THIS IS THE 75TH MEETING OF THE NCRA AND I THINK WE HAVE A NIGHTS SORT OF AGENDA LAID OUT FOR YOU TODAY. I'LL TURN IT OVER TO DAVID SO SORT OF CONTINUE TO WELCOME YOU AND INTRODUCE A COUPLE OF NEW MEMBERS THAT WE HAVE. BUT WE'RE ANXIOUS TO GET STARTED AND SO HAPPY THAT YOU'RE HERE. >> THANKS, AMY. WELCOME, EVERYBODY. APPRECIATE EVERYBODY TAKING THE TIME TO TRAVEL FROM NEAR AND FAR TO BE HERE AT THIS NCRA MEETING. IT'S A GREAT DAY TO BE TOGETHER, IT'S ALSO A SAD DAY BECAUSE OF THE RECENT PASSING OF ONE OF OUR MEMBERS, KIMBERLY KNEWMAN MCCOWN. I THIS Y'ALL GOT THE NOTICE ABOUT HER PASSING. SO HOPE WE CAN BAN TOGETHER AND DEDICATE THIS MEETING TO OUR FRIEND KIMBERLY. SHE WAS REALLY AN OUTSTANDING MEMBER OF THE GROUP AND ADDED A LOT TO OUR CONVERSATIONS AND WAS JUST SIMPLY GREAT TO BE AROUND. SO IF YOU WANT TO KNOW MORE ABOUT HER AS A PERSON, AND HER AS JUST A GREAT MEMBER OF THIS BOARD, PLEASE ASK ANY OF US. WE WILL HAVE A GREAT MEMORY WITH KIMBERLY TO SHARE. I KNOW THE NCI IS REACHING OUT. BEFORE I ONLY GETTING STARTED, I READ THIS OPENING STATEMENT. THIS IS THE BUREAUCRATIC PARTY OF -- PART OF WHAT WE DO. PROBABLY THE MOST ARTICULATE WILL BE ALL DAY BECAUSE IT'S WRITTEN HERE IN FRONT SO I CAN'T REALLY GO WRONG. AS COMMITTEE MEMBERS I WANT TO REMIND YOU THAT YOU MUST ABSENT YOURSELVES, ABSENT, WHO USES THAT IN THEIR NORMAL LANGUAGE? THE GOVERNMENT. YOU'RE RIGHT. ABSENT YOURSELVES DURING SPECIFIC DISCUSSIONS WHEN YOU -- WHENEVER YOU PARTICIPATION DELIBERATIONS ON A PARTICULAR PRODUCT PROGRAM OR OTHER SPECIFIC MATTER CONSTITUTE A CONFLICT OF INTEREST OR CREATE THE APPEARANCE OF ONE. IT IS INCUMBENT TO ADVISE THE EXECUTIVE SECRETARY AND ABSTAIN FROM ANY PARTICIPATION AND DISCUSSION OR ACTION REGARDING THAT MATTER. IN LIGHT OF CURRENT POLICIES GOVERNING CONFLICT OF INTEREST BASED ON FINANCIAL HOLDINGS SPECIAL GOVERNMENT EMPLOYEES WHICH WE ARE, WHICH INCLUDE ALL MEMBERS OF THIS COMMITTEE, WE MUST DEPEND UPON YOU TO VOLUNTARILY ABSENT YOURSELVES DURING ANY AND ALL DISCUSSIONS OF MATTERS THAT COULD CONCEIVABLY IMPACT STATUS OF THOSE HOLDINGS. WE TRUST YOUR JUDGMENTS IN THESES INSTANCES. BY LAW A QUORUM OF BOARD MEMBERS IS REQUIRED FOR EACH INSTANCE IN WHICH A VOTE OCCURS IN AN OPEN SESSION. DURING THIS MEETING A MINIMUM OF 7 APPOINTED MEMBERS MUST BE PRESENT TO VOICE THEIR VOTES. NEW MEMBERS NOT CURRENT MEMBERS OF ANOTHER NCI ADVISORY BOARD ARE NOT VOTING UNTIL THEY HAVE BEEN CLEARED BY THE NCI ETHICS OFFICE AND OFFICE OF HUMAN RESOURCES. I HAVE GIVEN SOME WELCOMING REMARKS BUT ONE THING WE'RE EXCITED ABOUT TODAY IS JUST TO WELCOME OUR TWO NEW MEMBERS OF THIS GROUP, MR. BANKS AND MS. LEECH. LOOK FORWARD TO THEM TO INTRODUCE THEMSELVES A BIT MORE BIOS I THINK YOU HAVE BIOS IN YOUR PACKETS TODAY F. GREG BANKS HAS BEEN AN OUTSTANDING MEMBER OF THE PATIENT ADVOCACY COMMUNITY AND OF THE RESEARCH ADVOCACY COMMUNITY FOR A VERY LONG TIME AND AN IMPORTANT MEMBER OF THE SWOG OR SOUTHWEST ONCOLOGY GROUP PATIENT ADVOCACY COMMITTEE, DEEPLY INVOLVED IN DIFFERENT PATIENT ADVOCACY GROUPS, IS A KNOWS PATIENTS AND KNOWS RESEARCH AND STUDIES THE JOURNALS. SO RICK IS REALLY EXCITED. DANIELLE IS NO STRANGER TO THE NCRA, HAS BEEN AROUND THIS GROUP FOR MANY YEARS. AND IS JUST ONE OF THE GREAT NON-PROFIT PATIENT ADVOCATES WE HAVE IN WASHINGTON AND THROUGHOUT OUR COUNTRY. SHE'S SENIOR DIRECTOR OF ADVOCACY AND GOVERNMENT RELATIONS AT SAINT BALL DISTRICT'S FOUNDATION, THE LARGEST NON-PROFIT IN OUR COUNTRY DEVOTED TOWARDS FINDING A CURE TO CHILDHOOD CANCER. HAD A GREAT EXPERIENCE WORKING WITH DANIELLE THE LAST FEW YEARS, AND A LOT HAS BEEN IN CHILDHOOD CANCER ADVOCACY WORKING WITH DANIELLE. DANIELLE ALSO IS A LEADER OF THE ALLIANCE FOR CHILDHOOD CANCER, LARGEST COALITION OF CHILDHOOD CANCER ORGANIZATIONS IN OUR COUNTRY. SHE'S A ROCK STAR ADVOCATE AND REALLY HONORED FOR HER TO BE JOINING THIS GROUP. SO WE HAVE A FULL AGENDA TODAY. I KNOW WE'RE GOING TO BE GOING ON TO THE BUDGET AND LEGISLATIVE UPDATE, WE JUST -- IN TERMS OF THIS AGENDA, WE GOT SOME IMPORTANT STUFF TO COVER, THE BUDGET AND LEGISLATIVE STUFF THAT MK AND TEAM ARE GOING TO COVER AND IT'S A CRITICAL TIME, OBVIOUSLY WITH CONGRESS REALLY DEBATING HEALTHCARE REFORM, ACTIVELY THIS WEEK, HAVING TO SEE IF THEY ARE GOING TO DO ANYTHING BEFORE SEPTEMBER 30th. THE NEXT FISCAL YEAR THE BUDGET PROCESS, ALL THESE THINGS ARE AT PLAY THE NEXT FEW WEEKS BEFORE CONGRESS EVENTUALLY DECIDES TO QUIT FOR THE YEAR. THIS IS A VERY WELL TIMED MEETING FOR ALL OF US TO COME TOGETHER TO LEARN WHAT'S AT STAKE AND WHAT WE CAN DO TO CONTRIBUTE TO STRENGTHENING CANCER RESEARCH AND THE ROLE OF THE NATIONAL CANCER INSTITUTE. WE WILL HAVE PART TWO ENGAGING DISCUSSION OF RARE TUMOR ENGAGEMENT NETWORK, VERY IMPORTANT INITIATIVE OF THE NCI WHICH NEEDS OUR HELP. THIS IS A SESSION WHERE WE CAN ROLL UP OUR SLEEVES, LEARN IN GREATER DEPTH WHAT THE RARE TUMOR ENGAGEMENT NETWORK IS TRYING TO DO AND SEE HOW WE CAN ACTUALLY TAKE SOME HOME WORK ASSIGNMENTS AND TO DOs BACK TO THE COMMUNITY TO TRY TO HELP THAT INITIATIVE. I KNOW YOU GOT THE SLIDES ON THAT AND PREPARED VOLUMINOUS QUESTIONS FOR THOSE DOCTORS AS I HAVE. I KNOW JULIE PREPARED 17 DIFFERENT QUESTIONS FOR THEM. I KNOW OTHERS HAVE AS WELL. THEN LATER WE WILL HAVE A GREAT DISCUSSION AROUND PRECISION MEDICINE CLINICAL TRIALS. THIS WILL BE A BIT OF MORE A BIG PICTURE, A LITTLE BIT OF MENTAL STRETCH IN THE SENSE OF THINKING BIG PICTURE HOW READY ARE WE AS A PATIENT COMMUNITY FOR THE CLINICAL TRIALS NETWORKS AND STRATEGIES OF THE FUTURE. WHAT CAN WE DO TO BETTER GET PATIENTS READY FOR THAT WORLD OF MAN TRIALS AND PERHAPS TOO FEW PATIENTS FOR THOSE TRIALS. THEN WE'LL HEAR FROM DR. LOWY AND HAVE AN OPPORTUNITY FOR GREAT DISCUSSION WITH HIM AS ALWAYS. SO WITH THAT >> I WANT TO TURN IT BACK TO AMY AND AMY SHOULD WE JUST MOVE TO MK? HOLLY? >> THANKS. SO MK IS GOING TO GIVE OUR LEGISLATIVE UPDATE AS DAVID MENTIONED. >> HI THERE P. GOOD MORNING, EVERYONE. GREAT TO BE BACK WITH THE NCRA. HOLLY GIBBONS IS GOING TO TALK ABOUT ONE OR TWO THINGS THAT ARE ON THE AGENDA HERE TODAY AND TAKING OVER FOR ME IF I GET A FIT OF COUGHING. I APOLOGIZE IN ADVANCE FOR THAT. IT WOULD BE GOOD IF I HAD A SENSE OF -- OKAY. I PRESSED THE ARROW, IT DIDN'T HAPPEN. ONE THING I'LL SAY WHILE WE'RE FIXING WHAT I MESSED UP HERE, THAT ERROR. THE ONE TIME THE PERSON IS NOT COVERING TO TELL ME WHAT TO DO. HEALTHCARE REFORM AND THE EFFORTS WE'RE ALL WATCHING, A LITTLE BIT OF A WET SAW WITH ONE MORE TIME HERE. THE ONLY THING I WILL SAY ABOUT THAT, I WILL TALK ABOUT THE APPROPRIATIONS PROCESS, WHAT WE HAVE SEEN FROM THE COMMITTEES AND WHAT OUR OUTLOOK IS FOR FY 18. THE REASON THERE'S A PRESS FORGET SOMETHING DONE AND HAVING ANOTHER VOTE BY SEPTEMBER 30th AND MANY OF YOU PROBABLY KNOW THIS, AND HAVE READ ABOUT IT IN THE POLITICAL REPORTING, ACTUALLY THIS LEVEL OF DETAIL IS STARTING TO GET INTO THE MAINSTREAM REPORTING. IS THAT WHEN THE FISCAL YEAR ENDS THE BUDGET RESOLUTION THAT PROVIDED RECONCILIATION INSTRUCTIONS WHICH IS A PROCESS WHERE THERE'S A BUDGET POLICY, SOMETHING HAS TO HAVE A BUDGET POLICY PIECE OF LEGISLATION TO QUALIFY FOR RECONCILIATION, WHAT THAT DOES PROCEDURALLY IS IT GIVES SENATE THE ABILITY TO PASS SOMETHING WITH A SIMPLE MAJORITY. SO THEY DON'T NEED 60 VOTES. SO THAT'S WHY THERE'S A PRESS TO GET ANOTHER HEALTHCARE REFORM VOTE DONE BEFORE SEPTEMBER 30th, END OF SEPTEMBER 30th BECAUSE RECONCILIATION INSTRUCTIONS EXPIRE AT THE END OF FISCAL YEAR SO IF THEY CAN'T GET IT DONE BY THEN THEY'RE IN A SITUATION OF REGULAR LEGISLATIVE SITUATION VOTE IN SENATE NEEDING 60 VOTES TO GET SOMETHING PASSED AND 50 IS A PROBLEM. THAT'S WHY THERE'S A PRESS NOW TO GET A SIMPLE MAJORITY. WHERE WE ARE FOR FY 18. THIS IS THE TYPICAL PROCESS HOW THE CYCLE IS SUPPOSED TO WORK. THE PRESIDENT WHITE HOUSE SCHMITZ A BUDGET PROPOSAL -- SUBMITS A BUDGET PROPOSAL USUALLY IN FEBRUARY. IF THE NEW ADMINISTRATION HAPPENS LATER BECAUSE THEY HAVEN'T HAD TIME FOR -- IN THIS PAST FISCAL YEAR IT HAPPENED LATE IN THE GAME BUT THAT WAS UNDERSTANDABLE BECAUSE OF THE CHANGE IN ADMINISTRATION. THEN THE CONGRESSIONAL APPROPRIATIONS COMMITTEE, THEY CONSIDER THE PROPOSAL, THEY PREPARE LEGISLATION. AS PART OF THAT PROCESS THEY HOLD HEARINGS, THEY CONSIDER SPECIFIC ASPECTS OF THE BILL AND TAKE THE PRESIDENT'S BUDGET AS A SUGGESTION. IT STARTS THE CONVERSATION. THE NEXT STEP CONGRESS RECONCILES AND FINALIZES APPROPRIATIONS BILLS BEFORE PASSING THEM SENDING THEM TO THE PRESIDENT FOR SIGNATURE AND WHEN SIGNED INTO LAW THEN THERE'S AN APPROPRIATIONS BILL WE CAN GET OUR FUNDING. SO FOR FY 18 WE ARE STILL BETWEEN STEPS TWO AND THREE. WE HAVE EDGED A LITTLE FURTHER DOWN THE TRACK HERE BECAUSE BOTH OUR APPROPRIATIONS COMMITTEES HAVE FINALIZED OUR BILLS. WE ARE NOT YET THAT MUCH CLOSER TO FINAL APPROPRIATION FOR FY 18. AS YOU KNOW, WE ARE NOT HAVING A SHUT DOWN AT THIS POINT AT THE END OF THE FISCAL YEAR BECAUSE THERE WAS A PREEMPTRY DECISION MADE WHERE ON FRIDAY SEPTEMBER 8 THE PRESIDENT SIGNED HR 601 INTO LAW. THIS WAS AN UNUSUAL COMBINATION OF PROVISION, JUST OVER 15 BILLION FOR VICTIMS OF HURRICANE HARVEY, A CONTINUING RESOLUTION THAT TAKES US THROUGH DECEMBER 8 PLUS A TEMPORARY EXTENSION OF THE DEBT LIMIT. NOW DEBT LIMIT I DON'T THINK ANYONE HAD IN MIND A THREE MONTH DEBT LIMIT INCREASE BECAUSE IT'S A VOLATILE POLITICAL ISSUE ALWAYS, IT IS USUALLY THE NECESSITY AND EXIGENCY OF DEBT LIMIT VOTE INCREASE HAS BEEN PART OF MANY BUDGET DEALS. IT IS A FACTOR THAT WILL T CATALYZE A DEAL OF SOME KIND BECAUSE THE GOVERNMENT HAS TO BE -- DEBT LIMIT HAS TO BE INCREASED WHEN THE TREASURY DEPARTMENT SAYS THERE'S NO MORE EXTREME MEASURES IT CAN TAKE, IT MUST BE DONE. IT'S A VERY POLITICAL SITUATION WHEN THERE'S A DEBT LIMIT INCREASE. IT'S BEEN PUNTED FOR A VERY SHORT TIME. WHAT'S THEN REPORTED IS THAT THERE WAS REALLY AN INTERESTING GETTING AN 18 MONTH DEBT REDUCTION EXTENSION. SO THEY ENDED UP WITH THREE AT THE END OF THE DAY. SO THIS MEASURE PASSED AND THE GOVERNMENT IS FUNDED THROUGH DECEMBER 8 SO WE'RE LOOKING AT A DRAMATIC DECEMBER WHEN THIS EXPIRES. THERE'S A VARIETY OF OTHER ISSUES HAVE TO BE DEALT WITH IN AND AREN'T THE BUDGET SO PRESIDENT'S BUDGET AS THIS GROUP IS FAMILIAR WE TALKED ABOUT AT THE LAST MEETING WAS RELEASED THE END OF MAY. IT WOULD HAVE INCLUDE AD 20% CUT TO NIH BUDGET COMPARED TO FY 18 -- I MEAN FY 17 LEVEL. SO THE HEARINGS THAT I WAS REFERENCING EARLIER THE HOUSE HAD THE HEARING IN MAY FOR THE NIH BUDGET AND SENATE HAS THEIRS END OF JUNE. DR. LOWY ATTENDED BOTH AND CAN ANSWER QUESTIONS. TE HOUSE BILL, WHAT WE SAW IN TERMS OF THE APPROPRIATIONS COMMITTEE REACTIONS AND RESPONSES TO THE BUDGET PROPOSAL, THEY REALLY DIDN'T LIKE THE IDEA OF CUTTING FUNDING FOR NIH. THE HOUSE BILL INCLUDED 1.$1 BILLION INCREASE OVER THE FY 17 ENACTED LEVEL. THAT WOULD HAVE BEEN 82 MILLION FOR NCI. THAT'S THE PROPORTIONAL SHARE. ALSO INCLUDED THE FULL 300 MILLION FROM THE 21st CENTURY CURES FUNDING, AUTHORIZED BY THE CURES LEGISLATION BUT HAS TO BE APPROPRIATED. THERE HAS TO BE STEP BY APPROPRIATIONS COMMITTEES TO DELIVER FUNDING. THE SENATE BILL INCLUDED A $2 BILLION INCREASE FOR NIH WHICH FOR NCI IS ABOUT 169 MILLION OVER FY 17 ENACTED LEVEL. THEY ALSO INCLUDED THE CURES TRANSFER. THESE ARE QUOTE FROM TWO CHAIRMEN, ROY BLUNT AND TOM COLE FROM OKLAHOMA AND MISSOURI RESPECTIVELY. THE REPORT LANGUAGE FOR APPROPRIATIONS COMMITTEES INCLUDED SOME PRETTY STRONG LANGUAGE ABOUT WANTING TO SUSTAIN THEIR INCREASE FUNDING INCREASES FOR NIH AND THIS IS THE THIRD YEAR THAT WE HAVE SEEN SUBSTANTIAL INCREASE. IT'S CERTAINLY AT THE COST OF OTHER PROGRAMS AND THIS IS A BIPARTISAN PRIORITY SO IT'S ONE OF THE THINGS IN -- ONE THING WE CAN AGREE ON. SO THERE WAS REALLY STRONG LANGUAGE IN THE REPORT CONTINUING SUPPORT FOR NIH FUNDING. THEY -- THERE WAS ALSO A FEW OTHER ITEMS DRESSED IN THE REPORT LANGUAGE, JUST IN TERMS OF THE RESPONSE OF THE PRESIDENT BUDGET, IT IS NOT UNCOMMON FOR ANY PRESIDENT BUDGET REQUEST AND ANY ROSTER OF APPROPRIATIONS COMMITTEES, YOU DON'T SEE A FULL SALE ADOPTION OF PRESIDENT BUDGET PROPOSAL. CONGRESS STATES THE POWER SERIOUSLY RESPONSIBILITY AND THIS IS ONE OF THE REALLY IMPORTANT FUNCTIONS THEY DO. WHEN YOU LISTEN TO APPROPRIATIONS CHAIRS TALK ABOUT THAT RESPONSIBILITY THEY WILL EMPHASIZE TRY TO FIND COMMON GROUND WHEN THEY CAN. THEY WILL REVIEW PROPOSALS FOR NEW INITIATIVES IN THE BUDGET. BUT IT'S NOT UNIQUE TO THIS YEAR AND THIS BUDGET. THERE IS VARIATION OF WHAT THE COMMITTEES DECIDE TO DO. HOUSE AND SENATE DON'T ALWAYS AGREE, IN THIS CASE THEY'RE FAIRLY ABOUT THE NIH SUPPORT ISSUE, REALLY IN LOCK STEP, THAT'S WHY I HAVE A PICTURE OF TWO CHAIRMEN TOGETHER BECAUSE SENTIMENTS THEY EXPRESS AND REPORT LANGUAGE AND COMMENTS THEY MAKE AT THE HEARINGS ARE REALLY CONSISTENT. BUT WE DON'T SEE A RUBBER STAMP OF THE PRESIDENT'S BUDGET EVER SO THIS IS NOT UNUSUAL. WHAT'S REALLY POSITIVE TO SEE IS THE SUPPORT OF STATEMENTS FOR NIH AND THE KIND OF -- WE SEE IN THE REPORT LANGUAGE IN BOTH HOUSE AND SENATE ENDORSEMENT OF THE IMPORTANCE OF BASIC RESEARCH. A LOT OF YOU ARE PROBABLY AWARE THE PRESIDENT'S BUDGET PROPOSAL INCLUDED SOME PROVISIONS TO CHANGE THE WAY INDIRECT COTSES ARE AWARDED TO UNIVERSITIES. -- COSTS ARE AWARDED TO UNIVERSITIES AND HOW THAT'S NEGOTIATED. WE SAW LANGUAGE IN BOTH HOUSE AND SENATE THAT WOULD PROHIBIT CHANGES TO THE SOMETIMES CALLED FACILITIES AND ADMINISTRATIVE COST OR F AND A, SAME THING INDIRECT COSTS F AND A, WE SAW LANGUAGE THAT WAS CLEAR ABOUT THE COMMITTEE'S THINKING THERE WAS NOT A PLAN, THEY WERE COMFORTABLE SUPPORTING AT THIS POINT IN TIME SO THEY PUT IN LANGUAGE THAT WILL ESSENTIALLY PRESERVE THE STATUS QUO AT LEAST THROUGH DECEMBER 8 SO THEY DON'T WANT TO SEE CHANGES AT THIS POINT TO THAT. THERE WERE PROVISIONS IN THE BUDGET PROPOSAL TO ELIMINATE THE FOGARTY INTERNATIONAL CENTER. WE SAW LANGUAGE IN THE APPROPRIATIONS REPORTS THAT THEY DECLINED TO SUPPORT THAT AND CONTINUE TO PROVIDE APPROPRIATION FOR FOGARTY. THERE WAS LANGUAGE IN THE BUDGET PROPOSAL THAT WOULD HAVE FOLDED AHRQ INTO NIH AND THERE WAS LANGUAGE DECLINING TO SUPPORT THAT PROPOSAL. I THINK SOME OF THESE THINGS ARE JUST PERHAPS DISCUSSED IN MORE DETAIL WITH AUTHORIZERS, THERE MAYBE MORE THOROUGH DISCUSSION WITH CONGRESS IN THE FUTURE. BUT A MESSAGE IN THE APPROPRIATIONS COMMITTEES WERE THIS IS TOO SOON, THIS IS OFF THE TABLE FOR NOW. THAT SIGNED INTO STATUTE BUT ONLY THROUGH DECEMBER 8. WE'LL SEE WHAT HAPPENS AFTER THAT. THE SLIDE ON THE SCREEN NOW I WANT TO THANK MY COLLEAGUES IN THE BUDGET OFFICE, CAROL CREATED THIS SLIDE AND THE ONE AFTER IT. SO THIS IS JUST TO SHOW YOU THE DIFFERENCE IN THE PROPORTIONAL DIFFERENCE FROM THE FY 17 ENACTED APPROPRIATION FOR NIH, WHAT THE PRESIDENT'S BUDGET PROPOSAL WOULD BE FOR FY 18, WHAT THE HOUSE MARK WAS SO WHEN PEOPLE SAY THE MARK, CHAIRMAN'S MARK THAT'S WHAT THE REPORT LANGUAGE THE LEVEL THAT WAS GIVEN IN THE DRAFT BILL. THEN THE SENATE ALLOWANCE SO YOU CAN SEE THEY'RE CLOSE, THE SENATE IS HIGHER BUT IT'S A DRAMATIC DIFFERENCE BETWEEN PRESIDENT'S BUDGET IN 17 AND PRESIDENT'S BUDGET AND HOUSE AND SENATE FOR 18. ALSO SLIDE FROM MY BUDGET COLLEAGUES THIS IS JUST SHOWING THE NATIONAL CANCER INSTITUTE APPROPRIATIONS WITH THE SAME IN THE SAME CATEGORIES FY 17 ENACTED. PRESIDENT'S BUDGETS REQUEST FOR FY 18 AND HOUSE AND SENATE MARKS. AND THE LITTLE GOLD BAR IS SHOWING THE CURES 300 MILLION ALLOCATION FOR CURES ALSO APPROPRIATED. SO I KNOW WE HAVE TALKED QUITE QUITE A BIT ABOUT AND I SEE YOU AT HILL EVENTS WHERE NCI PARTICIPATING AND WE ARE PLEASED TO HAVE THE OPPORTUNITY TO DO THAT AND APPRECIATE THE INVITATION TO BE PART OF THE DISCUSSIONS. AS YOU KNOW THERE'S STRONG BIPARTISAN SUPPORT FOR NIH AND NCI AND THIS YEAR HAS BEEN PARTICULARLY BUSY WITH VISITS. THESE ARE REALLY GREAT, GREAT OPPORTUNITIES FOR THE NIH TO THE MORE PEOPLE WHO ARE MAKING DECISIONS ABOUT OUR BUDGETS AND STATUTORY PROVISIONS THAT MIGHT AFFECT THE PROGRAM. THE MORE THEY UNDERSTAND THE PROCESS AND THE MORE ENGAGED THEY CAN BE AND MORE INFORMED THE BETTER. THIS AFTERNOON WE HAVE A VISIT BY THE CONGRESSIONAL BLACK CAUCUS NIH AND NCI BETTER PARTICIPATING IN THAT. THERE'S 13 MEMBERS ARE ATTENDING THIS REALLY REMARKABLE, FIRST TIME THIS HAPPENED WITH CONGRESSIONAL BLACK CAUCUS. INDIVIDUAL MENS VISITED BUT TO MY KNOWLEDGE THEY HAVE VISITED AS A CAUCUS. THIS IS EXCITING. WE HAVE BEEN TRYING TO HAVE THIS HAPPEN FOR A LONG TIME. SO WE HAD A LOT OF VISITS BY MEMBERS AND STAFF THIS YEAR AND IN 2017, OVER 20 MEMBERS AND OVER 50 STAFFERS VISITED WITH NCI WITH OUR RESEARCHERS, WITH DR. WIDEMANN WHO YOU WILL MEET LATER, SHE'S BEEN PART OF A LOT OF THOSE. DR. LOWY MAKES TIME FOR THESE AND IT'S A PRIORITY FOR US. THE PICTURE ON THE RIGHT HAND SIDE IS A VISIT WE HAD, TRYING TO REMEMBER THE DATE OF THE VISIT. THEY'RE BLURRING TOGETHER. EARLY JUNE. WE HAD NINE SENATORS COME TO VISIT TOGETHER, THAT IS UNUSUAL THEY USUALLY COME ONE AT A TIME AND IT'S A BIG DEAL AND CHAIR MAN BLOUNT BROUGHT WITH HI INVITATION. THAT WAS AN EXCITING VISIT. HERE IS ONE WE HAD IN AUGUST BY THE HOUSE BUDGET COMMITTEE, THEY HAVE NEVER VISITED. THAT'S EXCITING BECAUSE THERE'S A DIFFERENT -- THEIR FUNCTION IS DIFFERENT. THEY DON'T HAVE TO GET ENGAGED IN THE NIH BUDGET AND REVIEW LINE ITEM, THEY HAVE A BROADER AND NOTER PANORAMIC FUNCTION. SO THIS WAS REALLY EXCITING THEY CAME AND VISITED AND HERE VISITING WITH DR. JACK SHEERIN IN THE PEDIATRIC ONCOLOGY BRANCH WITH DR. WIDEMANN. THAT WAS A GREAT VISIT. I WANT TO ASK COLLEAGUES TO SAY A QUICK WORD ABOUT THE CHILDHOOD CANCER CAUCUS VISIT WHERE DR. STEVEN CHANNICK FROM ONE OF OUR DIVISIONS PARTICIPATED IN A DISCUSSION. >> I THINK WHEN THE BOARD MET LAST WE HAD JUST HAD STAFF MEMBERS TO CO-CHAIRS OF THIS CAUCUS OR FOUR CO-CHAIRS YOU SEE CHAIR MAN MCCALL IS ONE OF THE FOUNDING MEMBERS. CONGRESSMAN BUTTERFIELD, CONGRESSWOMAN JACKIE SPEAR AND CONGRESSMAN MIKE KELLY ARE THE OTHER CO-CHAIRS. THIS IS A WONDERFUL EVENT THAT HAPPENS EVERY SEPTEMBER DURING CHILDHOOD CANCER AWARENESS MONTH. LAST YEAR DR. LOWY PARTICIPATED. THAT'S SOMETHING WE WERE HONORED TO BE INVITED BACK TO AGAIN THIS YEAR. UNFORTUNATELY DR. LOWY COULDN'T JOIN, HE WAS RECEIVED THE LASKR AWARD THAT DAY BUT DR. CHANNICK,S A PEDIATRIC ONCOLOGIST AND EPIDEMIOLOGY AND GENETICS REPRESENTED NCI THIS YEAR AND ALSO STAYED TO JOIN THE ALLIANCE FOR CHILDHOOD CANCER ACT AND THE ART SHOW AFTERWARDS. SO JUST A WONDERFUL OPPORTUNITY TO SUPPORT THE WORK OF THE CAUCUS AND BE PART OF THAT EVENT. SO WE'RE HOPING TO HAVE CO-CHAIRS OF THE CAUCUS COME TO CAMPUS AT SOME POINT AS WELL. WE'LL KEEP YOU POSTED. CONGRESSMAN BUTTERFIELD IS ALSO MEMBER OF THE CONGRESSIONAL BLACK CAUCUS AND WILL BE HERE THIS AFTERNOON AS PART OF THAT EVENT BUT VISITING OUR CROSS STATE CANCER RESEARCH HERBS. RESEARCHERS. >> OUTLOOK FOR FY 18, IT'S COMPLICATED BECAUSE THEY NEED A BUDGET DEAL ANYONE WANTS. ALL THE CURRENT PROPOSALS WHETHER PRESIDENT'S, WHETHER HOUSE OR SENATE EXCEED THE BUDGETS CAPS. THERE NEEDS TO BE ANOTHER DEBT LIMIT INCREASE, THAT MAYBE THE CATALYST. WE SEE ALL THESE ROLLED TOGETHER AGAIN. IN TERMS OF BUDGET FOR FY 18, DEBT LIMIT AND BUDGET DEAL. IT LOOKS LIKE THERE'S SEVERAL MORE ITERATIONS OF ALL THIS OF HURRICANE RELIEF AID. SO I WANT TO SHOW YOU THIS SLIDE FROM THE NATIONAL JOURNAL SHOWS WHERE THE APPROPRIATIONS COMMITTEES, WHERE THE PROGRESS HAS BEEN. SO THE HOUSE COMPLETED ALL OF THEIR BILLS SO THEY'RE PASSED OUT OF THE COMMITTEE. SENATE COMPLETED SEVERAL BILLS INCLUDING THE LABOR HHS BILL THAT FUNDS NIH. WHAT DOES THIS MEAN? YOU MAY HAVE HEARD THERE WAS AN OMNIBUS PASSED IN THE HOUSE. THIS IS A QUOTE FROM A CQ ARTICLE. SO THAT THE HOUSE LEADERSHIP PUSHED A -- WEEKS AND WEEKS OF FEVERED WORK TO GET A 12 BILL OMNIBUS ROLLED TOGETHER AND PASS THROUGH THE HOUSE. THIS IS NOT MY OPINION, THIS IS WHAT IS BEING REPORTED THAT THEY CAST THEIR VOTES FOR THIS BILL BUT HAD NO FUTURE IN THE SENATE, WOULD NEVER BECOME LAW. THE IDEA IS TOO CONSERVATIVE IN TERMS OF >>SCOTT POLOKOFF SHY WRITERS TO PASS THE SENATE WHERE IT'S A DIFFERENT THING, SO I THINK THE POINT HERE IS THAT THE APPROPRIATORS ARE DOING EVERYTHING THEY CAN TO MOVE THIS PROCESS FORWARD. SO THERE ARE POLICY WRITERS THAT ARE NOT GOING TO PASS A SENATE VOTE BUT THIS WASN'T A HOUSE AND SENATE APPROPRIATIONS COMMITTEE DOING OMNIBUS TOGETHER, THIS IS THE HOUSE VERSION. SO THERE HAS BEEN SOME MOMENT UP, WE'RE HOPEFUL TO ACTUALLY SEE IN OMNIBUS THERE'S AN OPPORTUNITY FOR '01 NEW PROGRAMS AND NEW LANGUAGE FOR FY 18 WITH CURRENT FUNDING LEVELS ANT THE CHAIR OF THE HOUSE APPROPRIATIONS COMMITTEE IS QUOTED SAYING IT'S IMPERATIVE FOR BILLS TO BE SIGNED INTO LAW IN THE NEURO. ONE THING THAT'S TALKING ABOUT UNCERTAINTY AND INSTANT OF THREAT OF SHUT DOWN AND ALSO INSTABILITY CAUSE FOR PROGRAMS FOR PLANNING WHEN THAT I DON'T KNOW WHAT THE APPROPRIATION WILL BE THE NEXT YEAR AND HOW CHALLENGING THAT IS. I WILL JUST OPEN UP FOR QUESTIONS BUT IN TERMS OF STABILITY AND PLANNING FROM BUCKET PERSPECTIVE, THE BUDGET OFFICER CAN GIVE YOU A VIEW ON THAT AND WHAT THAT MEANS FOR PROGRAM PERSPECTIVE. SO ANY QUESTIONS NOW OR LATER IF YOU WANT TO DO QUESTIONS TOGETHER AFTERWARDS THAT'S WHAT WE'LL DO. >> THANKS. I THINK WE'LL HAVE LORI PRESENT. SO THE PRESENTATIONS CAN GO TOGETHER THEN WE'LL SAVE QUESTIONS TO THE END. >> GOOD MORNING, EVERYONE. PLEASED TO BE HERE. MY COLLEAGUE MICHELLE CANDY JOINED YOU IN JUNE, I APOLOGIZE I COULDN'T BE HERE. TODAY MICHELLE AND I ARE SWITCHING PLACES. SO MICHELLE IS BACK AT THE OFFICE AND AS WE'LL TALK ABOUT WHAT'S GOING ON AT THE OFFICE, YOU'LL UNDERSTAND WHY WE HAVE TO ALWAYS KIND OF SHARE DUTIES BUT I'M PLEASED TO HAVE THE OPPORTUNITY TO JOIN AND TALK HOW WE OPERATIONALIZE WHAT MK JUST TALKED ABOUT. SO THIS IS ONE OF MICHELLE'S SLIDES FROM JUNE THAT I HAD TO MODIFY AND JUST TO HIGHLIGHT THAT IN THE OFFICE OF BUDGET AND FINANCE WE'RE WORKING IN MULTIPLE FISCAL YEARS. I DID UPDATE THIS TO SHOW FISCAL YEAR 18 AS IN SIX DAYS WE WILL BE STARTING FISCAL YEAR 18. AND I THINK IT'S IMPORTANT TO LOOK FORWARD NOT BACKWARD SO NOT ONLY APPROPRIATION AND EXECUTION, WE'LL ALSO START OUR REPORTING PROCESS SO I'LL BRIEFLY GO THROUGH THE THREE FISCAL YEARS WE'RE FOCUS ON AND TALK ABOUT WHAT WE ARE -- WHAT ACTIVITIES ARE HAPPENING AT NCI. WE IN ARE IN THE FINAL STRETCH, FIVE THEYS IN FY 17. THIS IS A BIG TIME OF YEAR IN THE FEDERAL GOVERNMENT. WE WERE REALLY PLEASED THIS YEAR TO RECEIVE FUND THROUGH 21st CENTURY CURES CANCER MOON SHOT. AS YOU KNOW, THOSE FUNDINGS ARE NO YEAR DOLLARS. SO ON THE OPERATIONAL SIDE OF THE HOUSE, WE HAD TO GET ALL NEW ACCOUNTS SET UP FOR THOSE FUNDS. IT TOOK TIME AND WORKING ACROSS NIH HHS AND ONB AND TREASURY DEPARTMENT TO GET READY TO RECEIVE THOSE DOLLARS THAT CONGRESS PROVIDE TO US IN DECEMBER. THE CANCER MOON SHOT BLUE RIBBON PANEL WERE MOVING GETTING THINGS GOING GETTING RFAs IN THE STREET, GETTING THINGS READY TO GO. ON OUR SIDE OF THE HOUSE WE WERE TRYING TO GET THE MONEY. TRYING TO GET INTO NCI AND READY TO GET IT OUT THE DOOR. WE ARE DOING TWO CLOSE OUTS. CLOSING THE ANNUAL ACCOUNT FY 17 OVER $5 BILLION BUT ALSO CLOSING OUT 300 MILLION FOR CANCER MOON SHOT. CLOSING OUT MOON SHOT, THAT MONEY CAN CARRY OVER FROM YEAR-TO-YEAR, THAT'S THE POINT OF KNOW YOUR MONEY, WE ARE AWNING LIKE ANY OTHER CLOSE OUTS. WE'RE TRACKING DOLLARS AND GRANTS AND CONTRACTS GET OUT THE DOOR, MAKING SURE EVERYTHING HAPPENS AN CLOSELY SETTING A TARGET HOW MUCH WE THINK WE'RE CARRY OVER AND WHAT THE STRATEGY IS BY CARRYING THOSE DOLLARS OVER. AS YOU KNOW IF YOU WORKED IN THE FEDERAL GOVERNMENT AS YOU DO IN YOUR OWN INSTITUTES AND ORGANIZATIONS, FISCAL YEAR-END CLOSE IS INSTITUTE WISE ACTIVITY AND OUR OFFICE IS A TEAM OF NINE. OUR TEAM HAS OVERSIGHT RESPONSIBILITY AND WE HAVE THE STRATEGIC PLAN HOW TO IMPLEMENT YEAR-END CLOSE. WE MEET REGULARLY WITH DR. LOWY AND HIS TEAM, TO TALK ABOUT WHAT HE'S HOPING AS FY 17 COMES TO A CLOSE. MY PRIMARY RESPONSIBILITY IS TO MAKE THAT HAPPEN FOR HIM. I WORK CLOSELY WITH SISTER OFFICES, OFFICE OF GRANTS ADMINISTRATION, OFFICE OF OAFIA. THERE'S FOLKS THAT TRACK FUNDING OF GRANTS AND OFFICE OF SITUATIONS. THIS IS POINT WE'RE DOING CALLS MULTIPLE TIMES A WEEK TO MAKE SURE OUR PLAN IS WORKING OUT AND THAT WE'RE MOVING TOWARDS SATURDAY AT NOON WHEN I WILL CERTIFY AND SAY WE ARE DONE. I'M LOOKING FORWARD TO THAT. SO IT'S A REALLY EXCITING TIME RIGHT NOW, SEVEN DAY A WEEK MODE, GREAT TIME TO BE MAKING SURE SCIENCE IS HAPPENING IN THE TIME LINE AND PRETTY MUCH PUTTING OUT FIRES. ONCE WE MOVE TO SUNDAY AND MONDAY NEXT WEEK WE'LL BEGIN REPORTING ACTIVITIES SO WE IMMEDIATELY MOVE INTO REPORTING MODE. WE PROVIDE FUNDING FOR A VARIETY OF RESOURCES INCLUDING OUR FACT BOOK. WE ARE WORKING CLOSELY, I HAVE A PRIORITY IN OFFICE TO MAKE SURE THE FACT BOOK COMES OUT IN TIMELY MANNER AND MAKE SURE IT'S OUT AND USEFUL, I SEE MY COLLEAGUES FROM OFFICE OF COMMUNICATION. SONA IS, WHOING TO MAKE SURE THE DATA IS OUT AND AVAILABLE AND USEFUL FORMAT. SO WE MOVE INTO 17 REPORTING. AS MK TALKED ABOUT WE'RE CLOSED WE'RE NOT NERVOUS ABOUT SUNDAY COMING. WE WILL BE OPEN AND CONTINUING TO BE OPEN THROUGH DECEMBER 8. AS YOU MAY KNOW, THE WAY FCR WORKS, NCI RECEIVE AS PRORATED APPROPRIATION FOR 69 DAYS IN THE CR THAT EQUALS 18.9% OF THE CLEAR SO TAKE 69 OVER 365 DAYS YOU GET 18.9%. THERE'S AN ACROSS THE BOARD REDUCTION EXTREMELY COMMON IN CR. THEY TAKE 17 ENACTED LEVEL, THEY TAKE REDUCTION OUT AND THEN THEY GIVE US THE PROPORTION OF THE MONEY FOR THE 69 DAYS. WHAT WE DO ONCE WE THEN RECEIVE THE APPORTIONMENT IS THEN WE PROVIDE ALL NCI DIVISIONS OFFICES AND CENTERS WITH THEIR PRORATED OPERATING BUDGET FOR THE CR PERIOD. AND WE MAKE SURE ANY ANOMALIES MAJOR GRANTS, ACTIVITIES, THE FOLKS EXPECT TO HAPPEN IN THE 69 DAYS THEY HAVE THE MONEY THEY NEED TO MAKE IT HAPPEN. WE JUST TAKE THAT ACTION AND WE MOVE IT INTO OPERATING PLANS. IN THE CR THERE IS SECOND YEAR MOON SHOT FUNDING AT 300 MILLION, THE SAME CALCULATION TAKES PLACE AND WE WILL HAVE ACCESS TO 18.9% OF THAT MONEY AS WELL. DECEMBER 9TH ADS MK DISCUSSED WE'LL SEE WHAT HAPPENS. AND THEN WE'RE POISED TO MAKE SURE THAT WE HAVE AN APPROPRIATION READY TO GO. I WILL TELL YOU THAT DR. LOWY HAS CONTINUED TO HAVE US RUN SCENARIO PLANNING FOR 18. AND WE HAVE BEEN RUNNING SCENARIO PLANNING FOR MONTHS. SO WE ARE READY TO GO BASED ON WHATEVER ENDS OP HAPPENING. OR WE SHUT DOWN A PERIOD OF TIME WE'RE READY FOR THAT AS WELL. THAT'S PART OF WHAT THE OFFICE DOES IS RUN SCENARIO PLANNING. FOR FY 19 THE BUDGET FORMULATION OF THE PRESIDENT'S BUDGET IS ACTIVELY UNDERWAY. NIH HAS BEEN RESPONDING TO QUERIES FROM HHS AND TO ONB. ONB'S NORMAL PROCESS YOU MIGHT BE FAMILIAR WITH IS IN THEIR BUDGET DEVELOPMENT PROCESS AND THEY NORMALLY PASS BACK THEIR DECISIONS FOLLOWING THE THANKSGIVING HOLIDAY. HERE AT NIH WE DO HAVE A DIFFERENT BUDGET FORMULATION PROCESS THAN OTHER AGENCIES THAT YOU MAY WORK WITH. OR HAVE WORKED AT. WE DON'T BUILD AN NCI SPECIFIC BUDGET TO GO FORWARD. NIH BILLION DOLLARS THE BUDGET FOR ALL INSTITUTES AND CENTERS ON OUR BEHALF. OUR BUDGET JUSTIFICATION IS DWIGHT SHORT. 39 PAGES LAST YEAR. IT IS A VERY RETROSPECTIVE PROFESSIONAL BUDGET JUSTIFICATION PROVIDING EXAMPLES OF PROGRAMS AND WHAT WE HAVE DONE IN THE PAST. AND ALL THE GREAT THINGS WE HAVE DONE AND MAKES THE VARIETY OF TABLES THAT WE HAVE TO REQUEST THE NEW FUNDING. NCI IS IN A UNIQUE POSITION TO HAVE THE AUTHORITY TO DO A PROFESSIONAL JUDGMENT BUDGET. THAT PROFESSIONAL JUDGMENT BUDGET CAME OUT IN SEPTEMBER. OR I BELIEVE IN AUGUST. AND THAT IS THE OPPORTUNITY WE CAN BE PROSPECTIVE. WE CAN LOOK FORWARD AND SAY THESE ARE THE AMAZING THINGS WE WOULD LIKE TO DO SO THAT DOCUMENT IS OUT AND WE HAVE WORKED ACROSS NIH, THERE'S ORGANIZES THAT HAVE THE SAME AUTHORITY AND WE WANT TO MAKE SURE OURS WAS TIMED WITH THEIRS. SO WE RELEASE THE BUDGET PORTION EARLIER THAN THE ANNUAL PLAN. YOU CAN SEE WE HAVE THOSE NUMBERS OUT. THOSE ARE THE THREE YEARS I'M FOCUSED ON RIGHT NOW. MK, HOLLY AND I WOULD BE HAPPY TO ANSWER ANY QUESTIONS YOU HAVE FOR US. >> ANY QUESTIONS? >> THIS IS RICK BANKS. CURIOUS AS TO WHETHER THERE'S ANY WORK -- I'M SURE THERE'S BEEN SOME WORK DONE ON MEASURING THE VALUE OF THE RESEARCH BEING FUNDED HERE. COULD YOU TALK A LITTLE BIT ABOUT HOW THE HEALTH ECONOMISTS WEIGH IN IN TERMS OF DRIVING THAT VALUE DISCUSSION? IT'S IMPORTANT, THERE'S A CHALLENGE OF THE AMERICAN PUBLIC IN TERMS OF UNDERSTANDING THE VALUE OF WHAT THEY'RE GETTING. THERE'S A ROLE FOR ADVOCACY IN THAT PROPOSITION. CURIOUS WHAT KIND OF WORK HAS BEEN DONE IN TERMS OF ARTICULATING THAT. >> IF I'M UNDERSTANDING YOUR QUESTION, WHAT COMES FROM NIH FUNDED RESEARCH, WHAT ARE THE RESULTS FOR PATIENTS AND >> FOR EXAMPLE AT SWAB WE HAVE DONE RESEARCH THAT SPOKE TO MILLIONS OF PATIENTS LIVES SAVED. I USE THAT AS AN EXAMPLE, THAT'S NOT QUANTITATIVE FINANCIAL BUT INDICATIVE OF THE KIND OF THINGS I THINK THAT THE HEALTH ECONOMIST CAN HELP US WITH. WE CAN BE MORE POWERFUL RAISING OUR VOICES RELATIVE TO RESEARCH IF WE HAVE SOMETHING TO HANG OUR HATS ON THROUGH SOCIAL MEDIA OR WHATEVER THAT ARTICULATES THE VALUE OF WHAT THE AMERICAN PUBLIC IS GETTING. >> THAT IS A REALLY GREAT POINT AND SOMETHING THAT WE'RE COGNIZANT OF. THERE IS NOT ONE WAY THAT HAPPENS. IF YOU GO TO NIH WEBSITE YOU WILL SEE A WHOLE SECTION ABOUT THE ECONOMIC BENEFITS THEY ARE TRYING TO HIGHLIGHT BENEFITS FOR PATIENTS ACROSS DISEASE AREAS. AT NCI WE ARE ALWAYS TRYING TO MAKE SURE THE MESSAGE WE INTEGRATE THAT INTO EVERY CONGRESSIONAL MESSAGING,, EVER BRIEFING BUT IT'S NOT ONE SPECIFIC WAY. WE MIGHT BE TALKING BAYING IS RESEARCH AND ONE OF THE THINGS WE FIND IS A REALLY IMPORTANT CHALLENGE TO MAKE SURE THERE'S AN UNDERSTANDING OF BUDGET GOES TO BASIC RESEARCH AND HOW CRITICAL THAT IS TO ADVANCES THAT YOU DON'T GET THE BREAK THROUGH DRUG, YOU DON'T GET INCREDIBLE ADVANCES IN IMMUNOTHERAPY WITHOUT DECADES OF INVESTMENT. THAT'S SOMETHING THAT NEEDS TO BE UNDERSTOOD, SO WE TRY TO BLEND THOSE INTO EXAMPLES WHEN THERE'S A SPECIFIC DISEASE AND THERAPY THAT WE CAN MAKE THAT REAL. WE DON'T FOCUS A LOT FROM OUR MESSAGING ABOUT THE ECONOMIC IMPACT THOUGH WHEN WE TALK TO GROUPS IN A PARTICULAR REGION OR STAFFERS FROM A PARTICULAR STATE OR DISTRICT, WE ALWAYS KNOW WHAT THE GRANTS ARE TO THEIR AREA, WITH THEIR SBIR PROGRAM, IT'S EASIER TO HAVE SPECIFIC METRICS THERE FOR BUSINESSES THAT ARE LAUNCHED FOR JOBS CREATED. BUT REALLY WE FOCUS MORE ON THERAPIES, PRACTICE CHANGING CLINICAL TRIALS. IT'S AS MUCH SOMETHING WE DON'T HAVE I WOULD SAY NOT ONE CONCENTRATED AREA OF FOCUS BUT IT IS SOMETHING THAT IS PART OF ALL OUR COMMUNICATIONS. I THINK YOUR POINT IS A GOOD ONE BECAUSE WE NEED TO FIGURE WHAT IS THE BANDWIDTH? WHAT IS THE ATTENTION SPAN AND ZOOMING BACK SAYING HERE IS WHAT YOU NEED TO UNDERSTAND ABOUT WHERE THAT MONEY IS SPENT AND WHAT IT MEANS. I THINK THAT'S SOMETHING WE ARE CONSTANTLY TRYING TO FIND WAYS TO REFLECT IN WAYS THAT ARE ACCESSIBLE AND MEANINGFUL FOR OUR CONSTITUENCY AND OUR AUDIENCES. I DON'T KNOW IF YOU HAVE ANYTHING TO ADD. IT'S CERTAINLY SOMETHING MEMBERS ARE INTERESTED IN AND WE WORK WITH DISEASE CAUCUSES FOR EXAMPLE, IN SOME WAYS IT'S A MORE NARROW FOCUS OF THE SAME QUESTION. BUT I THINK THAT'S A GOOD POINT, IT'S A WONDERFUL THING FOR ADVOCATES TO DO BECAUSE THERE ARE WAYS YOU CAN PROMOTE THAT MESSAGE THAT WE CAN'T. SO THANK YOU FOR YOUR QUESTION. >> MK, HOLLY THANKS. FIRST OF ALL GREAT JOB I THINK ON THE GETTING SO MANY MEMBERS OF CONGRESS TO SEE WHAT IS DONE HERE, THAT SOCIALIZATION IS OBVIOUSLY VALUABLE TO EDUCATING DECISION MAKERS ABOUT APPROPRIATION, BUDGETING, LEVELS OF SUPPORT. IT'S INTERESTING TO SEE CORRELATION BETWEEN RISING NUMBER OF CONGRESSIONAL VISITS TO BETHESDA, AND NUMBER OF TRIPS OF THE DIRECTOR TO NCI DESIGNATED CANCER CENTERS IN URBAN AND RURAL SETTINGS. BOTH INCREASE AND BIPARTISAN SUPPORT IN CONGRESS. WE'RE GETTING IN A CROWD OF STUDIES THERE'S SOME CORRELATION BETWEEN THOSE TWO THINGS. FOR THE PATIENT COMMUNITY GREAT WORK ON THAT, THE QUESTION ON HEALTHCARE FORUM IS OBVIOUSLY NOT OVER UNTIL'S OVER. -- UNTIL IT'S OVER BUT ONE THING THAT IS CONCERNED AMONG MANY THINGS IS WHETHER IT'S THE LATEST ONE THE GRAM CASSIDY OR OTHER VERSIONS. IS HOW WILL THESE PROPOSALS AFFECT CANCER RESEARCH. IN PARTICULAR FOR EXAMPLE IF SOMETHING IS REPLACED WITH AFFORDABLE CARE ACT IS REPLACED WHERE IT'S SIGNIFICANTLY MODIFIED AND STATES CAN CHOOSE WHICH BENEFITS THEY'RE GOING TO COVER, AND WHAT HAPPENS TO THE WHOLE CONCEPT OF INSURANCE COVERAGE FOR ROUTINE MEDICAL CARE ASSOCIATED WITH CLINICAL TRIALS, YOU NEED INSURANCE SYSTEM TO SUPPORT THINGS THAT GO AROUND A CLINICAL TRIAL WHETHER IT'S AN NCTN RUN TRIAL OR A NON-NCTN RUN TRIAL. SO JUST WONDERING IF THAT IS A TOPIC THAT'S -- YOU GUYS HAVE BEEN DISCUSSING IS HOW THESE ISSUES WILL AFFECT CLINICAL RESEARCH. >> I THINK IT'S VERY IMPORTANT, SOMETHING WE'RE PAYING ATTENTION TO. WITHOUT SOMETHING THAT'S ADVANCED, I DON'T KNOW WHAT'S GOING TO HAPPEN WITH THIS EVERY TIME I CHECK THE NEWS IT'S LOOKING A LITTLE LESS LIKELY THAT THEY'RE GOING TO BE ABLE TO DO SOMETHING BY SEPTEMBER 30th. I THINK YOU'LL SEE A LOT OF ATTENTION THIS ISSUE WITH OVAC WITH ACS CAN AND AACR AND ASCO. I THINK THOSE ARE APPROPRIATE FORUMS TO TAKE PLACE AND GROUPS LIKE NCRA TO BE PART OF THOSE DISCUSSIONS BECAUSE THAT'S CRITICALLY IMPORTANT NOT JUST FOR CANCER RESEARCH BUT FOR CANCER TREATMENT. SO IT'S CERTAINLY SOMETHING WE'RE GOING TO BE WATCHING AND WORRYING ABOUT. BUT I THINK IT'S TOO EARLY TO TELL HOW THAT PIECE WILL PLAY OUT. (INDISCERNIBLE) BUT CERTAINLY SOMETHING WE'LL BE WATCHING. (OFF MIC) >> YOU'RE EXACTLY RIGHT. WITH IT BE KNOW YOUR MONEY, IT'S APPROPRIATED IN ONE YEAR SO IT'S APPROPRIATED IN 17 BUT WE CAN CARRY OVER MONEY INTO THE FUTURE YEAR. SO WE GET AN ACCOUNT, IT'S MORE LIKE YOUR CHECKBOOK SO IT DOESN'T EXPIRE. WITH OUR ANNUAL APPROPRIATION, THE MAJORITY OF MONEY, THE $5 BILLION WE HAVE TO HAVE IT OBLIGATED COMMITTED OR OBLIGATED BY SEPTEMBER 30th AND THAT'S WHAT'S GOING ON RIGHT NOW. IF IT'S NOT COMMITTED OR OBLIGATED BY SEPTEMBER 30th, THEN YOU DO LAPSE IT BUT ALL THAT MONEY WE DO HAVE FIVE YEARS TO MAKE CORRECTIONS TO IT. THE MONEY DOESN'T RETURN TO THE TREASURY IN AN ANNUAL ACCOUNT UNTIL AFTER FIVE YEARS. SO THE REAL BENEFIT OF THE KNOW YOUR MONEY FOR THE CURES MOON SHOT IS THAT WE AS WE DO RIGHT NOW WE HAVE A STRATEGIC PLAN OF HOW WE WANT TO MOVE MONEY AND WE DIDN'T NEED TO HIT 300 MILLION TO THE PENNY ON SEPTEMBER 30th BECAUSE WE HAVE A PLAN FOR 18 AND WE KNOW WE NEED SOME OF THAT MONEY IN 18. IN ADDITION TO THE 300 MILLION WE'RE HOPING TO GET IN 18 ADS WELL. >> LORI, REAL QUICK WHILE YOU'RE UP THERE. YOU MENTIONED THE WORK THAT YOU DO TO PREVENT LAPSES. CAN YOU EXPLAIN THAT A LITTLE BIT MORE SO THAT PEOPLE UNDERSTAND THE UNDERPINNINGS? >> SURE. SO TO PREVENT LAPSE OF FUNDING WHAT WE DO -- DR. LOWY HAS BEEN FOR MONTHS BEING VERY CLEAR WITH US WHAT OUR INSTRUCTIONS WERE FOR FY 17. FOR FY 17 WE ARE SUPPOSED TO MAKE INVESTMENTS NOW TO MAKE SURE THAT WE BEST POSITION OURSELVES FOR 18 AND BEYOND. DR. LOWY IS EXTREMELY CLEAR YOU KNOW BETTER THAN ME, MAJORITY OF MONEY OUT THE DOOR FOR THE GRANTS IS MORTGAGE MONEY, MORTGAGING THINGS OVER FIVE OR SEVEN YEAR PERIOD AND WHAT DECISIONS YOU MAKE NOW BEFORE YOU'RE ENCLOSED HE WANTS TO MAKE SURE WE'RE NOT CREATING HUGE TAILS FOR OURSELF, MAJOR MORTGAGE DEBT IN THE OUTYEARS. GIVEN UNCERTAINTY OF 18 HE KNEW WE WOULD BE UNCERTAIN FOR 18 AS SOON AS PRESIDENT'S BUDGET CAME OUT SAYING WE NEEDED TO COME OUT WITH 20% REDUCTION. AND WHAT WE WERE LOOKING FOR AND WHAT HOLLY AND MK KNEW MOST IMPORTANT NUMBERS IS HOW THE SENATE AND SENATE MARKS AND HOW THEY RESPONDED TO THE PRESIDENT'S BUDGET. THERE CONTINUES TO BE UNCERTAINTY WHAT'S GOING TO HAPPEN FOR THE REST OF THE FISCAL YEAR. FOR YEAR-END CLOSE WE HAVE A VARIETY OF FACTORS THAT WE PLAY INTO MUCH MONEY WE WILL PUT OUT THAT IS MORTGAGED MONEY IN THE GRANTS, HOW MUCH WE'RE PUTTING OUT IN CONTRACTS AND ARE WE MAKING STRATEGIC DECISIONS IN OUR CONTRACTING AND OBVIOUSLY OUR INTRAMURAL PROGRAM. WE ARE PLACING OURSELVES TO LAPSE A VERY LITTLE BIT AMOUNT OF MONEY AND WHAT THAT MEANS IS WE LEAVE MONEY IN THE 17 ACCOUNT, WE DIDN'T COMMIT IT OBLIGATE IT BUT IT IS AVAILABLE IN OCTOBER FOR US TO CORRECT THINGS. YOU HAVE A BILL THAT COMES IN AND IT DOESN'T COME IN BY SEPTEMBER 30th WE STILL HAVE TO PAY THAT BILL BUT WE HAVE TO PAY IT BUT WE RECEIVE THE SERVICE SO I NEED TO HAVE A BUNCH OF MONEY IN 17 ACCOUNT AVAILABLE TO PAY THAT INVOICE WHEN IT COMES IN. IT'S A RISK DISCUSSION AND MY COLLEAGUE AND I ARE SICK OF USING THE WORD RISK BUT THAT'S ALL I TALK ABOUT WHAT'S THE RISK IF WE TAKE THE ACTION, WHAT'S THE RISK IF WE DON'T. WE HAVE THE MAKE SURE WE DON'T HAVE AN ANTI-DEFICIENCY ACT VIOLATION AND THAT'S NOT MY GOAL BEING NCI BUDGET OFFICER, TO HAVE A VIOLATION. WE TAKE GREAT CARE AND WE DO A LARGE AMOUNT OF TRACKING OUR SISTER OFFICES OUR SISTER OFFICES ARE PUSHING THE BUTTONS TO SPEND THE MONEY. WE'RE KEEPING TRACK AND MAKING SURE THE GAME PLAN IS WORKING AND STAYING WITHIN OUR PARAMETERS. IS THAT WHAT YOU WERE --? I APOLOGIZE. YOU HAD A QUESTION? >> MIGHT BE A LITTLE BIT RELATED BUT CAN YOU BRIEFLY DESCRIBE WHAT IT MEANS WITH THE SHUTDOWN? WE'RE TALKING ABOUT HAVING MONEY IN THE BANK, SHUT DOWN IMPACTS THINGS DIFFERENTLY AND FROM A DIRECT PATIENT PERSPECTIVE WHAT'S THE REAL DANGERS FORGIVE ME, RISK ASSOCIATED WITH THE CLINICAL TRIALS GOING ON THAT ARE STAFFED EVERY MAN TRACKED WITH REAL DANGER. >> THE REAL DANGER AS DR. LOWY AND COLLINS EXPLICITLY SAID TO CONGRESS AND OTHERS, THE SHUTDOWN IS THE WORST THING THAT CAN HAPPEN IN THE INTRAMURAL PROGRAM. HARD DECISIONS HAVE TO BE MADE OF WHAT ARE WE GOING TO KEEP DOING AND ARE WE GOING TO TURN PATIENTS AWAY WHO ARE PLANNING TO COME. SO A SHUTDOWN IS ABSOLUTELY THE WORST THING THAT CAN HAPPEN HERE. I'M SURE THERE ARE WORST THINGS THAT CAN HAPPEN, IT'S A TERRIBLE THING THAT CAN HAPPEN HERE. FROM AN OPERATIONAL STANDPOINT FOR ALL OF US WHO DO NOT DIRECTLY IMPACT PATIENT CARE, WE DON'T COME TO WORK. WE SHUT DOWN AND THERE'S MORE MONEY THERE. FOR ANY OF US TO COME TO WORK OR TO DO ANYTHING, THERE'S A SMALL COHORT I BELIEVE TO 600 PEOPLE AT NCI WHO COME TO WORK EVERY DAY. PROVIDING DIRECT PATIENT CARE OR SUPPORTK DIRECT PATIENT CARE. AND HAVE MORE TO ADD TO THAT BUT IT'S A SCENARIO THAT WE HAVE TO ALWAYS PREPARE OURSELVES FOR BUT WE PREPARE ON A REGULAR BASIS. WE VOLS HAVE TO PREPARE FOR OCTOBER 1 AND WE WILL PREPARE FOR IT FOR DECEMBER 9. WE JUST HAVE TO BE READY TO GO. >> FOR THOSE WHO DON'T KNOW ME, I'M ANN -- THE DEPUTY EXECUTIVE OFFICER AT NCI AND I WAS ONE OF THE 600 PEOPLE THE LAST TIME WE DID THE UNFORTUNATE INSTANCE OF SHUTTING DOWN AND THINK THE FUNDAMENTAL THING TO KNOW IS THAT THE REAL TERMS OF THIS YOU CAN'T COMMIT ANY FUNDING TO DO ANYTHING NEW. SO FOR THOSE WHO MIGHT REMEMBER THE SHUT DOWN ANDERSON COOPER STANDING OUTSIDE THE CLINICAL CENTER TALKING ABOUT HOW PEOPLE ARE UNABLE TO GET TO CLINICAL TRIALS. YES. THAT IS FACTUALLY CORRECT. HOWEVER, PEOPLE WHO WERE IN CLINICAL TRIALS IN THE CLINICAL CENTER WERE BEING CARED FOR, PEOPLE WHO HAD APPOINTMENTS AND WERE IN THE SYSTEM TO BE CARED FOR, BEING CARED FOR, WE WEREN'T ABLE TO START A NEW TRIAL OR ADD ANYONE TO A PROPERTY IF THEY WENT -- ESSENTIALLY INCURRING NEW COST TO THE GOVERNMENT. THESE ARE NUANCES BUT I WILL TELL YOU WE WORK HARD TO ENSURE ANYBODY WHO WAS ON THAT LIP OF WAITING TO COME TO THE CLINICAL CENTER HAD AN APPOINTMENT IN THE SYSTEM AND WAS ABLE TO GET CARE. WHAT WE SAW IN THAT LAST SHUT DOWN WAS A GROUND SWELL NOT ONLY WITHIN THE NCI AND THE NIH BUT ALSO IN CONGRESS TO SAY THIS IS NOT ACCEPTABLE IN THE FACE OF SHUT DOWN. I WILL SAY EVERY TIME WE SHUT DOWN DONE IT THAT MUCH BUT IT'S A LITTLE DIFFERENT. THERE'S NUANCES TO WHAT'S PERMITTED AND WHAT'S NOT BUT WHAT WE DO IS WORK VERY HARD IN OUR PLANNING ADS LAURA SAID TO ENSURE THAT NOT ONLY ARE PATIENTS ARE CARED FOR BUT INVESTMENTS MADE OVER YEARS OF RESEARCH THAT THOSE INVESTMENTS ARE NOT LOST. YOU CAN IMAGINE IF AN EXPERIMENT YOU HAVE INVESTED YEARS IN GETTING READY TO RUN IN A PIVOTAL MOMENT WE SHUT DOWN, THAT RESEARCH COULD BE LOST. WE WORK VERY HARD TO TRY TO FULFILL OUR OBLIGATION AS FEDERAL EMPLOYEES TO INCUR COSTS FOR THE GOVERNMENT BUT AT THE SAME TIME SERVE THE PEOPLE WHO COUNT ON THIS MOST. THAT'S CANCER PATIENTS. THERE'S A LOT OF NEGOTIATION THAT GOES AROUND WHAT A SHUTDOWN LOOKS LIKE FOR US HERE. IT IS NO ONE WINS IN THAT CIRCUMSTANCE. >> CAN I ADD TO THAT, I THINK THAT THERE IS A -- TO THE CONTRARY OF TWEETS YOU MIGHT HAVE SEEN FROM PEOPLE IN THE EXECUTIVE BRANCH INCLUDING THE TREASURY SECRETARY ABOUT SHUTDOWNS BEING GOOD. OR THAT WE NEED ONE. THERE'S VERY LITTLE INTEREST VAST MAJORITY OF MEMBERS OF CONGRESS FOR A SHUT DOWN, POLITICALLY RISKY, THERE'S FALL OUT AND OUR CHAIR MAN AND HOUSE APPROPRIATION SUBCOMMITTEE FOR LABOR TOM COLE MADE SEVERAL -- CONTROLLING THE WHITE HOUSE AND SENATE, THE GOVERNMENT SHUTDOWN HE USED THE WORD STUPIDEST THING HE HEARD OF. SO IS IT'S NON-SENSICLE, IT IS RISKY POLITICALLY, NO ONE WANTS THIS. REALLY. SO WHAT WE WILL FIND IS A GREAT DEAL OF ENERGY LEADING UP TO THE SHUT DOWN QUESTION, AFTER WHEN WE HAD THE SHUT DOWN BEFORE, NON-STOP THE ONLY QUESTION WE GOT, I CAN'T REMEMBER THE NUMBER OF STAFFERS CALLING BECAUSE THEIR BOSSES WANTED TO KNOW WHAT WERE THE AFFECTS. THEY WANT TO TALK UP TO THE MINUTE. THESE ARE AGONIZING DECISIONS AT TOP LEVEL NCI AND INTRAMURAL PROGRAM, THESE ARE PEOPLE'S LIVES. PEOPLE AREN'T GETTING ON CLINICAL TRIALS CLINICAL CENTER IN THE CENTER FOR CANCER RESEARCH FOR NON-SERIOUS SITUATIONS. SO IT'S SOMETHING THAT IS SO INEFFECTIVE AS A POLITICAL DEVICE, I'M HOPEFUL THIS IS NOT SOMETHING WE LEARN FROM THE EXPERIENCE BEFORE BUT APPROPRIATORS BRING THAT UP WHEN THEY VISIT NCI AND WHEN THEY MEET PATIENTS THEY BRING THEM UP. I'M SORRY, YOU HAD A QUESTION. IS THERE TO WRAP ME HEAD AREN'T, IF THERE'S SIX FOLKS WORKING DURING SHUT DOWN WHAT IS THE AVERAGE DAY TO DAY AMOUNT OF FOLKS THAT ARE WORK SOMETHING >> IF YOU INCLUDE EVERYONE, LORI CAN CORRECT ME WE HAVE ABOUT 3300 WHAT WE CALL FTEs BUT WE HAVE FELLOWS AND CONTRACTORS. SO OUR BIG N IS SOMEWHERE IN THE NEIGHBORHOOD OF 6,000, SO IT'S ABOUT TEN PERCENT. I WILL TELL YOU THAT HAVING BEEN ONE OF THOSE PEOPLE, YOUR BASICALLY WEARING A MULTITUDE OF HATS. THE ONLY THING I DIDN'T DO WAS PATIENT CARE. AND PATIENTS APPRECIATE THAT. THESE ARE PEOPLE ON THIS CAMPUS, IS THAT WHO YOU'RE REFERRING TO? >> AND ELSEWHERE. IT'S -- HAS TO BE FEDERAL EMPLOYEES. >> IF WE THINK ABOUT THE NCTN, OPERATIONS, BIOSTATISTICIANS, THAT FUNDING WOULD BE CUT OFF. IF THEY HAVE FUNDING THEY DON'T GET NEW MONEY FOR US. >> IF YOU ALREADY HAVE YOUR MONEY YOU CONTINUE THE OPERATE. >> SO ENOUGH MONEY WITHIN FISCAL YEAR THAT DOESN'T GET CUT OFF? >> CORRECT. BUT YOU WOULDN'T HAVE ANYBODY TO CALL AT NCI. >> THEY CALL ME. AND I'M SURE WE'LL FIGURE IT OUT. >> SO YOU KEEP WORKING. >> YOU GET THE BUSY SIGNAL. >> CANCER CENTERS AROUND SHUTTING DOWN BUT WE CAN'T GIVE THEM -- IF THEY HAD A FUNDING COMING AND OFFICE WAS GOING TO FLIPPING THE SWITCH -- >> I WOULDN'T FLIP THAT SWITCH. SHE WOULDN'T BE ABLE TO DO THAT. >> OFFICE OF GRANTS ADMINISTRATION WOULDN'T FLIP THE SWITCH FOR NEW MONEY. THE MONEY IS OUT THE DOOR, ANYTHING IN PROCESS HERE AT NCI WOULD PAUSE. >> THERE COULD BE LIKE RDCN FREDERICK WHO IS TAKING CARE OF ANIMALS, WHO ARE CENTRAL TO A XENOGRAPH PATIENT DISEASE MODEL, YOU HAVE TO KEEP THEM ALIVE, THESE ARE THINGS THAT ANN IS REFERRING TO LIKE THE RESEARCH IS -- IT'S A PROGRESSION. SO YOU CAN'T JUST STOP. IS THAT DIRECT PATIENT CARE, IT'S VERY IMPORTANT RESEARCH RESOURCE FOR EXTRA MULE RESEARCH ACROSS THE COUNTRY. THE LOSS IF WE HAD TO STOP IS TREMENDOUS. SO WE HAVE TO FIND WAYS TO KEEP THAT GOING BUT IT IS I CAN'T IMAGINE HOW PEOPLE WHO ARE TAKING CARE OF ANIMALS ARE BECAUSE THEY'RE NOT GOING TO GIVE A BIG EXCEPTION. MORE EXCEPTIONS FOR PATIENT CARE HERE AT THE CLINICAL CENTER THAN YOU ARE FOR A REALLY SIGNIFICANT ANIMAL RESEARCH PROGRAM. IT'S A TERRIBLE THING. ONE OF THE MOST TERRIBLE TO HAPPEN. WE'RE HOPEFUL THAT THE COOLER HEADS WILL PREVAIL. NO ONE BENEFITS FROM THIS. SO THERE IF THERE IS NOT A CLEAR I JUST SAY THAT WE PLAN FOR A LOT OF THINGS THAT DONE HAPPEN. FROM THAT IS PART OF THE GREAT PART OF MY JOB IS THAT IT DOESN'T HAPPEN. WE CALL IT FUNNY MONEY, WHATEVER BUT THESE THINGS DON'T HAPPEN. HAPPY TO DO IT PART OF OUR JOB BUT WE DON'T LIKE IT WHEN IT BECOMES OPERATIONALIZED. >> THANK YOU FOR THAT REPORT. I THINK EVEN SPEAKER RYAN HAS SAID HE DOESN'T REALLY WANT A GOVERNMENT SHUTDOWN. BUT WHAT ISN'T WIDELY KNOWN IS WHAT YOU SAID EARLIER IS THAT DURING A CR, THERE'S A REDUCTION FUNDING. NOT A COMMONLY KNOWN FACT, DO YOU EXPECT THAT REDUCTION FUNDING, THAT TEMPORARY PERIOD OF TIME TO HAVE ANY EFFECT ON ANY SIGNIFICANT EFFECT ON NCI OPERATIONS. >> WE DO NOT. AT THE LOW PERCENTAGE THAT IT IS, LESS THAN ONE PERCENT WE DO NOT. IN ADDITION AS YOU KNOW THE MAJORITY OF NCI COLLARS GO OUT THE DOOR IN THE FOURTH QUARTER. SO WE CAN MAKE SURE THE FIRST QUARTER, IT'S ALMOST THE ENTIRE QUARTER FIRST QUARTER CR WE CAN ENSURE EVERYONE HAS THE MONEY THEY NEED WITHIN THE TOTAL ALLOCATION THAT WE HAVE. AND AS I SAID WE WORK WITH LEADERSHIP, THEY HAVE SOMETHING THAT NEEDS TO HAPPEN. WE KNOW SOMETHING IS NOT HAPPENING IN THAT PERIOD AND MAKE SURE THEY HAVE THE MONEY THAT THEY NEED. SO WE CAN CONTINUE. AS BEST AS WE CAN BUSINESS AS USUAL UNDER THE CR. >> THANKS AGAIN TO ALL OF YOU FOR THAT PRESENTATION. I KNOW WE NEED TO SET UP FOR THE NEXT SECTION FOR THE RARE TUMOR ENGAGEMENT NETWORK. WE'RE TAKING A TWO MINUTE BREAK FOR TECHNICAL SERVICES. AND REGINA, ARE YOU STILL ON THE PHONE HANGING IN THERE WITH US. WE DON'T KNOW. >> SORRY, I WAS MUTED. >> THAT'S OKAY, JUST WANT TO MAKE SURE YOU'RE STILL THERE. SO WE'RE GOING TO TAKE A TWO MINUTE BREAK THEN COME BACK FOR THE NEXT SECTION. >> I JUST WANT EVERYBODY TO KNOW THAT THIS IS JUNE MCKOY. I'M ON THE CALL. >> HI, JUNE. WELCOME. JUNE AND REGINA, SINCE YOU'RE NOT HERE TODAY YOU'LL OWE LATTES AT THE NEXT MEETING. >> WILL DO. THANK YOU. >> BE BACK IN TWO MINUTES. WE'RE PLEASED TO BE ABLE TO MOVE TO THE NEXT AGENDA ITEM, RARE TUMOR ENGAGEMENT NETWORK. PLEASED THAT DR. ARMSTRONG, DR. WIDEMANN, DR. GILBERT, ARE HERE TO PRESENT AND RECAP WHAT WE DID IN THE LAST MEETING AND TAKE US THROUGH WHERE WE NEED TO GO IN THE NEAR TERM FUTURE WITH THE RARE TUMOR ENGAGEMENT NETWORK LEADING UP TO HOW WE CAN HELP. SO WITH THAT, IT'S A GREAT PLEASURE TO INTRODUCE DR. TERRY ARMSTRONG. >> THANKS, DAVID. WE APPRECIATE THE OPPORTUNITY TO COME BACK. WE KNOW THIS IS A VALUABLE TIME AND WE APPRECIATE THAT WE HAVE BEEN GIVEN A SECOND CHANCE TO TALK TO YOU. THERE ARE A COUPLE OF NEW MEMBERS THAT WE'RE GO FOG GO THROUGH A FEW OF THE BACKGROUND SLIDES WE WENT THROUGH THE LAST TIME AND KIND OF MOVE ON. WE WANT THE MAJORITY OF TIME TO BE A DISCUSSION, WE WANT INPUT FROM YOU ON SOME THOUGHTS WE'RE HAVING AS WE MOVE FORWARD. DR. RILEY IS AT GRANT REVIEW SO CAN'T BE WITH US BUT DR. GILBERT AND WIDEMANN ARE HERE PARTICIPATE IN DISCUSSION AS WELL. SO JUST REVIEW AGAIN, THIS IS A INTROMURAL PROGRAM FUNDED THROUGH THE MOON SHOT MECHANISM. IT'S A COLLABORATIVE EFFORT BETWEEN PEDIATRIC ONCOLOGY AN NEURAL ONCOLOGY WITH THE PURPOSE TO REALLY CONNECT WITH THE EXTRAMURAL COMMUNITY IN TERMS OF CLINICIANS AS WELL AS PATIENTS. AND THIS IS OUR MISSION STATEMENT WICH WAS SHARED BEFORE, WE'RE ABOUT DEVELOPING A NETWORK OF CLINICAL AND RESEARCH SITES AS WELL AS A NETWORK WITH PATIENTS AND ADVOCACY AND INTERFACE THAT WE CAN ADVANCE THE CARE OF PATIENTS WITH THESE RARE TUMORS THROUGH SHARED INFRASTRUCTURE AND TRIALS. HOW WE ENVISION THIS NETWORK WORKING IS FIRST WE WANT TO CONNECT DIRECTLY WITH THESE PATIENTS AND I'LL SHARE OUR EXPERIENCE WITH THE -- THAT'S ONE FOCUS. WE WANT TO DO THAT THROUGH SOCIAL MEDIA AND ELECTRONIC AND OTHER MEDIA SOURCES AS WELL AS PARTNERING WITH ADVOCACY ORGANIZATIONS. OUR FIRST INPUT FROM PATIENTS WILL BE TOTALLY WEB-BASED. WE WANT TO CONNECT WITH PATIENTS WHERE THEY LIVE AND WHERE THEY ARE. AND LET THEM SHARE THEIR STORY WITH US. IN TERMS OF DIAGNOSIS, TREATMENT, AND THEIR CURRENT HEALTH HISTORY. WE'RE ALSO GOING TO BE ASKING QUESTIONS TO TRY TO UNDERSTAND UNDERLYING DEEMOLOGY AND RISK FOR -- EPIDEMIOLOGY AND LIST FOR RARE TUMORS AFTER WEB-BASED ENGAGEMENT PATIENTS ARE INVITED TO COME TO THE NIH CAMPUS, COMING HERE WILL ALLOW US TO MORE FULLY INTERROGATE BIOSPECIMENS, TUMOR, BLOOD AND OTHER SPECIMENS PROVIDE A SECOND OPINION FOR THEM WITH WORLD RENOWN EXPERTS ON THE CARE OF THEIR TUMOR. AND THEN EVALUATE FOR EVIDENCE OF SOME TARGETED APPROACHES THAT WE CAN THEN ENROLL THEM INTO CLINICAL TRIALS. WE PLAN TO HAVE CLINICAL TRIALS AVAILABLE TO PATIENTS HERE. NETWORK WITH OTHER INSTITUTIONS AROUND THE COUNTRY AND AROUND THE WORLD TO ALLOW PATIENTS TO HAVE THESE TREATMENTS WHERE THEY LISP. THE DATA THEY COLLECT WE'LL STORE IN A CLOUD BASED BIOREPOSITORY WHICH WE WILL ALLOW SHARING OF DEIDENTIFIED DATA WITH RESEARCHERS AROUND THE WORLD. WE WANT TO ASK QUESTIONS TO ADVANCE CARE OF PATIENTS AND SHARE INFORMATION WITH PATIENTS THEMSELVES AND DEVELOPING EDUCATIONAL MATERIALS AND SUPPORT MATERIALS FOR PATIENTS THAT WILL LIVE WITHIN THIS WEB PORTAL, ACCESSIBLE TO PATIENTS IN THE NETWORK AND THOSE WHO MAY NOT BE INVOLVED. WE HAVE THREE GOALS, FIRST TO DEVELOP INFRASTRUCTURE ACROSS NATIONAL AND INTERNATIONAL SITES, WILL BE COLLECTING AND ANALYZING ALL AVAILABLE DATA FROM PATIENTS AND THIRD QUARTER PROVIDERS AS WELL AS FROM ANALYSIS OF BIOSPECIMENS THAT WE CAN DO IN A COST EFFECTIVE WAY HERE. AND BEING ABLE TO DEVELOP A NETWORK TO TRANSLATE THESE FINDINGS INTO NEW CLINICAL TRIALS AND TREATMENT APPROACHES FOR RARE CANCERS. SO YOU HAVE BEEN PROVIDED ALL THE SLIDES WE SHARED THE LAST TIME THAT PROVIDES MORE DETAIL ABOUT THE PROGRAM, JUST A COUPLE OF OTHER POINTS TO RECOGNIZE, WE DO HAVE TWO PRIMARY APPROACHES ONE IN ADULT NEURAL ONCOLOGY OR BRAIN AND SPINAL CORD TUMORS, AND LOOKING AT TUMORS THAT GO FROM PEDIATRIC TO ADULT POPULATION. THESE ARE EXISTING INSTITUTIONS THAT WE ALREADY HAVE NETWORKS DEVELOPED WITH THAT WE WILL BE ADDING TO IN ORDER TO BRING THESE TRIALS TO PATIENTS WHERE THEY LIVE. >> CAN I ASK A FOUNDATIONAL QUESTION? WHAT IS A RARE TUMOR IN THIS CONTEXT. >> DR. GILBERT. >> IF YOU DEFINE RARE TUMOR BY FDA IT'S LESS THAN 50,000 CASES RARE DISEASE LESS THAN 50,000 DISEASES IN THE UNITED STATES PER YEAR. IN THE CONTEXT OF CNS CANCER WHERE THE TOTAL INCIDENCE OF ALL TUMORS IS ABOUT 80,000 AND ABOUT HALF OF THEM ARE BENIGN. WE ARE FOCUSING ON THE ONES THAT HAVE AN INCIDENCE LESS THAN A THOUSAND PER YEAR. IT'S A STRINGENT -- >> COULD WE GO ONE CLICK DOWN FROM THERE. >> IF WE THINK ABOUT HISTOLOGY BIOMARKERS VARIANTS, SUBTYPES, THESE ARE ALL ONE CLICK DOWN FROM RARE TUMOR, OR TUMOR. SO ARE WE -- SOME OUR MAJOR DISEASES ARE COMPRISED OF SOME RARE DISEASES, EVEN THOUGH THEY'RE COMMON DISEASES SO I'M JUST TRYING TO FRAME THIS SO THAT WE GET THE RIGHT PERSPECTIVE ON THIS. I THINK IT'S CENTRAL TO WHAT WE'RE TRYING TO DO HERE AND WHO THE OUTREACH WOULD BE. >> IT'S A GREAT POINT. I'LL LET DR. WIDEMANN ALSO COMMENT FROM THE PEDIATRIC PERSPECTIVE. IN ESSENCE WHAT YOU'RE SAYING IF YOU LOOK AT OUR MOST COMMON BRAIN TUMOR WHICH IS GLIOBLASTOMA AND YOU DO MOLECULAR SUBTYPING YOU CAN EASILY FIND GROUPS THAT DROP BELOW THAT MAGIC THOUSAND MARK. YOU'RE ABSOLUTELY CORRECT. IT'S JUST OUR FIRST ROLL OUT WE WANT TO FOCUS IN ON AREAS OF COMPLETE UNMET NEED. SO THERE'S VERY LITTLE INFORMATION ON TUMOR SUBTYPES THAT WE HAVE SELECTED. BUT ULTIMATELY THE GOAL WILL BE TO USE THE SAME TYPE OF OUTREACH, SAME TYPE OF RESEARCH AND CLINICAL TRIAL INFRASTRUCTURE TO GET EXACTLY AT THE POINT THAT YOU ARE DESCRIBING. WE HAD TO MAKE A SELECTION. THERE ARE -- EVEN WITHOUT MOLECULAR SUBTYPES OF THE MORE COMMON TYPES OF BRAIN AND SPINAL CORD TUMORS THERE ARE ALREADY 130 HISTOLOGIC DESIGNATIONS. WE HAVE SELECTED TEN TO FOCUS ON. BUT THE CONCEPT THAT YOU HAVE ALLUDED TO, IS SOMETHING THAT WE HAVE HAD DISCUSSION AND I THINK IT WOULD BE EASY ONCE WE CREATE THE INFRASTRUCTURE TO OVERLAY THAT ON TO THAT. BUT FOR OUR FIRST PASS IT'S CONCEPTUALLY VERY EASY FOR PEOPLE TO SAY -- WHICH HAS AN ANNUAL INCIDENCE OF 500, IS A RARE CANCER TO SAY THAT AN FGFR TAC 1 FUSION GLIOBLASTOMA IS 3% GBM, THEREFORE YOU'RE LOOKING AT 300 PATIENTS A YEAR IN THE UNITED STATES IS HARDER TO DO OUT OF THE STARTING BLOCK. SO WE WANTED TO GO AND BE IN A SITUATION WHERE WE CAN VERY EASILY DESCRIBE WHAT OUR GOALS ARE. BUT OUR ULTIMATE GOAL IS TO LOOK AT THESE DISEASES IN WAY THAT MAKES IT AS EASY AS POSSIBLE TO FIND STRATEGIES FOR TREATMENT. OVERCOME LOGISTICAL CHALLENGES IN ENROLLING FOR THAT SPECIFIC GLIOBLASTOMA SUBTYPE. BUT I THINK OUR APPROACH AS DR. ARMSTRONG WILL NOW TALK ABOUT IN APENDAMOMA SHOW A ROAD MAP TO EXTEND TO CLASSICALLY DEFINED RARE CANCER AND THEN HAVE THE ULTIMATE GOAL OF GOING INTO THE MOLECULARLY DEFINED SUBTYPES OF WHAT HAVE BEEN CLASSIC HISTOLOGICALLY DEFINE TUMORS. THAT'S THE WAY WE WILL GO ABOUT IT. AND HOPEFULLY THAT STRATEGY WILL BE SUCCESSFUL. I THINK IT WILL BE HARDER NOW. THE BIOLOGY IS STARTING TO GET TO A POINT WHERE WE ARE ABLE TO SUBTYPE. BUT THEN WHERE DO YOU DRAW THE LINE, UNDER GLIOBLASTOMA THERE ARE A FEW BUT EVERY FEW MONTHS FORTUNATELY DISCOVERIES COMING UP WE WERE AGE TO MAKE SUBDIVISIONS. WE'RE GOING IN THAT DIRECTION. SO WILL BIOLOGY OF THOSE MORE COMMON DISEASES, NOT JUST -- >> I THINK NOTHING REALLY TO ADD OTHER THAN PEDIATRICS, THERE'S MORE -- MOST PEDIATRIC PATIENTS IN CLINICAL TRIALS EVEN WITH CHILDREN'S ONCOLOGY GROUP THERE ARE A NUMBER OF TUMORS WHERE DISEASES ARE SO RARE THAT CLINICAL TRIALS CANNOT BE MEANINGFULLY PERFORMED SO THOSE OTHERS THAT WE ARE FOCUSING ON AND WILL BE WORKING WITH THE COLLABORATING INCLUDING (INAUDIBLE) SELECT THOSE. >> THANK YOU FOR THAT QUESTION. ONE OF THE THINGS WE WERE ASKED IS TO GIVE AN UPDATE ON THE STATUS OF THE PROGRAM AND WE'RE EXCITED TO SAY THAT FUNDING HAD BEEN SECURED AND WE DO HAVE START OF OCTOBER 1st. TO START THIS PROGRAM, CHARGE IS TO DO TEN YEARS OF RESEARCH IN FIVE YEARS SO WE'RE TAKING THAT SERIOUSLY AND WE HAVE STARTED HIRING AS WELL AS SETTING UP INFRASTRUCTURE. SO WE'RE FINALIZING THE FINANCIAL AND CONTRACTUAL ISSUES, WE HAVE A MEETING TO MOVE THAT FORWARD. IT'S -- WE'RE HIRING PERSONNEL, WE POSTED PROGRAM MANAGERS ONCOLOGISTS NEURO-ONCOLOGISTS, NURSE PRACTITIONERS GENETIC COUNSELORS AND ADVOCACY LIAISON NAVIGATOR, RESEARCH AND WEB COMMUNICATION SPECIALISTS, SO ALL THOSE POSITIONS ARE POSTED AND WE WILL BE HIRING THEM WITH THE GOAL TO HAVE KEY PERSONNEL IN PLACE IN OCTOBER TO START RIGHT AWAY. WE HAVE PROTOCOLS THAT HAVE BEEN DEVELOPED AND ARE CURRENTLY IN DEVELOPMENT THAT INCLUDES NATURAL HISTORY STUDY THAT WILL ALLOW US TO BRING PATIENTS TO THE NIH, BE ABLE TO INTERROGATE SAMPLES, LOOKING AT UNDERLYING METHYLATION STATUS OR GENETIC STATUS OF THE TUMORS. WE WILL BE ABLE TO COLLECT PATIENT REPORTED OUTCOMES AND CLINICAL HISTORY ON PATIENTS AND FOLLOW THEM LONGITUDE NAYLY. WE ALSO HAVE -- LONGITUDINALLY, WE ARE HAVING APEDAMOMA EXPANNING TO OTHER CANCERS. WE HAVE AN IMMUNOTHERAPY BASKET TRIAL READY FOR MOON SHOT IN OCTOBER AND A SECOND STUDY FOR POSITIVE APPEND MOW MA WHICH IS IN DEVELOPMENT AND WE HOPE TO LAUNCH IN THE SPRING. SO THAT'S AN UPDATE, KIND OF A THOUSAND FOOT OVERVIEW OF WHETHER WE'RE DOING. I HOPE YOU CAN SEE WE'RE EXCITED. WE'RE STARTING RIGHT AWAY TO GET THINGS SET SO WE CAN START ON OCTOBER 1. SO WE REALLY WANTED TO COME HERE TO TALK ABOUT ENGAGEMENT AND SEEK YOUR COUNCIL AND ADVICE AND WE HOPE THIS IS A RELATIONSHIP WE CAN CONTINUE AS WE MOVE THINGS FORWARD. WE HAVE A SERIES OF QUESTIONS THAT WE LIKE TO POSE TO YOU BUT I THOUGHT I WOULD SHARE EXPERIENCE THAT WE HAVE LEADING US TO HOW WE'RE DOING THIS PROGRAM GOING FORWARD. THESE ARE QUESTIONS WE POSE THE LAST TIME FOR THOSE WHO ARE HERE, WE'RE GOING TO DRILL DOWN ON A FEW OF THESE AT THE END OF MY LAST PART OF THE PRESENTATION. I WANT TO SHARE EXPERIENCE TO GUIDE WHAT WE'RE THINKING ABOUT DOING WITHIN THE NETWORK AND GET YOUR FEEDBACK ON IT. IN 2009 WE DEVELOP A PARTNERSHIP WITH PHILANTHROPY DISCERN FOUNDATION, COLLABORATIVE RESEARCH NETWORK FOCUSED ON UNDERSTANDING THE DISEASE OF APPEND MOW MA. IT'S A RARE CNS CANCER THAT OCCURS IN THE BRAIN OR THE SPINE AND INVOLVES CHILDREN AND ADULTS. IN THE U.S. EACH YEAR THERE'S A LITTLE OVER A THOUSAND ADULTS DIAGNOSED AND 185 CHILDREN DIAGNOSED EACH YEAR. WHEN WE LOOK AT LITERATURE SERIES REPORTED ON STUDIES ON 30 TO 40 PATIENTS. BACK IN 2009 WE DECIDED FIRST TO LOOK AT OUR EXPERIENCE AT MD ANDERSON. WHAT DID PATIENTS GO THROUGH, WHAT IS THE COURSE. WE LOOK BETWEEN 1990 AND 2007. THERE ARE 123 PATIENTS SEEN AT MD ANDERSON. LARGE eCANCER HOSPITAL IN THE WORLD THIS LED US TO THINK THAT MAYBE THESE PATIENTS AREN'T GOING TO CENTERS OF EXCELLENCE FOR THEIR CARE. WE NEEDED TO REACH THEM IN SOME OTHER WAY. WE LAUNCHED A WEB-BASED OUTCOME SURVEY ON THE GLIOMA OUTCOMES PROJECT DONE A FEW YEARS EARLIER IN GLIOBLASTOMA. WITHIN LESS THAN A YEAR WE HAD ALMOST 120 ADULT PATIENTS WHO SIGNED UP AND SHARED EXPERIENCE. WHAT WE LEARN FROM THAT, OUT OF THOSE 118 PATIENTS THERE WERE 66 SEPARATE PROVIDERS PROVIDING CARE TO THESE PATIENT AND MAJORITIES WERE COMMUNITY NEUROSURGEONS OR FAMILY PRACTICE ES AND NOT ONCOLOGISTS. SO WE NEEDED TO REACH OTHER CARE PROVIDERS IN ORDER TO PROVIDE CARE -- BETTER CARE TO THESE PATIENTS BUT ALSO REACH THOSE PATIENT DIRECTLY, IT WOULD BE IMPOSSIBLE TO REACH EVER PROVIDER CARING FOR THESE PATIENTS. SO WE CONTINUED THIS SURVEY AND AT THE SAME TIME DEVELOPED A NETWORK WITH INSTITUTIONS AROUND THE COUNTRY TO BE ABLE TO GATHER WHAT THEY HAVE AT THEIR SITES IN TERMS OF PATIENT OUTCOME DATA TUMOR TISSUE AND TO DEVELOP THE TISSUE REPOSITORY. EACH SITE AROUND THE UNITED STATES, THERE WERE 28, WE DISCOVERED HAD 30, 25 TO 30 CASES MAXIMUM AT EACH OF THEIR INSTITUTIONS. SO IT'S IMPOSSIBLE FOR ANY ONE OF THOSE SITES TO INTERROGATE THE DISEASE. SO WE DEVELOP THIS REPOSITORY WE CENTRALLY HOUSE AN ANALYZE THE TISSUE AND COLLECTED THE CLINICAL ANNOTATION. SIMILAR TO TCGA BUT CLINICAL ANNOTATION WAS MUCH BETTER THAN IS IN THE TCGA. AT THE SAME TIME WE CONTINUED OUR OUTCOMES WORK THROUGH WEB-BASED PORTAL AND WE DID A FOLLOW-UP SURVEY AT THE SOCIO ECONOMIC IMPACT OF APPEND MOW MA IN PATIENTS INTERESTINGLY WE WERE ABLE TO GET FOLKS WHO WERE ON THE LOWER END OF INCOME. SO WE HAD 15% WHO EARNED LESS THAN $20,000 PER YEAR. WE ALSO HAD ABLE TO REACH PEOPLE AT VARIOUS EDUCATION LEVELS AND THAT WAS ONE OF THE OUR CONCERNS USING WEB-BASED PORTALS TO BE ABLE TO GET A DIVERSE POPULATION. WE HAD REPRESENTATION FROM EVERY STATE IN THE UNITED STATES AND REPRESENTATION FROM COUNTRIES AROUND THE WORLD. INTERESTING AT THAT TIME I FOUND OVER OF 0% PATIENTS HAD A LOSS OR CHANGE IN THEIR EMPLOYMENT RELATED TO THIS TUMOR. THIS IS THE TYPE OF TUMOR TALKING TO CLINICS THEY SAY THIS IS ONE OF THE GOOD ONES. BECAUSE PATIENTS CAN LIVE FOR YEARS. WE FOUND THE IMPACT OF PATIENT ON DAILY LIFE WAS QUITE SIGNIFICANT. AT THE SAME TIME AS WE CONTINUED THAT WORK WE LOOKED TO MASS ONE OF THE LARGEST COLLECTIONS OF TUMOR TISSUE WITH ALMOST 700 CASES OF APENDAMOMA WHICH WE HAVE TUMOR SAMPLES AN ANNOTATION AND WORK WITH RESEARCHERS AT SAINT JUDES AND SICK KIDS AND OTHER INSTITUTIONS TO ANALYZE THIS TUMOR TISSUE AND ABLE TO RECOGNIZE DIFFERENCES IN SURVIVAL BASED ON TUMOR GRADE BUT MOST IMPORTANTLY THERE WERE NINE SUBTYPES OF APPEND MOW MA THAT EXISTED. SO THIS TISSUE REPOSITORY WAS HELPFUL IN BRINGING THAT FORWARD. AS WE CONTINUE THE OUTCOMES PROJECT AND PUBLISHED AGAIN, IN 2016, AT THAT TIME WE HAD 264 PATIENTS, ABLE TO IDENTIFY SIGNIFICANT IMPACT ON PATIENTS AND BEGIN TO DEVELOP EDUCATIONAL MATERIALS TOWARD THE ISSUES THAT THEY HAD. PATIENTS HAD SIGNIFICANT PAIN, SPINE TUMOR PATIENTS OVER 75% NEEDED NARCOTIC ANALGESICS TO MANAGE PAIN. AGAIN, 60% CONTINUED TO REMAIN UNABLE TO WORK OR HAVING A CHANGE IN EMPLOYMENT. WE WERE ABLE TO PROVIDE EDUCATIONAL MATERIALS ON DISABILITY AND LOSS OF EMPLOYMENT. SO IN ORDER TO CONTINUE THAT WORK AND DEVELOP IT FURTHER, WHEN WE CAME HERE, WE DECIDED TO MARRY OUR APPEND MOW MA OUTCOMES PROJECT WITH A EPIDEMIOLOGICAL RISK STUDY. NO ONE LOOKED TO SEE WHAT RISK FACTORS THESE PATIENTS MAY HAVE FOR THE DEVELOPMENT OF THE DISEASE. APPEND MOW MA HAD BEEN INCLUDED IN OTHER CANCER EPIDEMIOLOGIC SURVEYS BUT MOST INCLUDE ONLY A SMALL FRACTION. SO WE MARRIED THE STUDIES TOGETHER EPIDEMIOLOGIC RISK STUDY AND OUTCOMES STUDY WEB-BASED PATIENTS REGISTER ONLINE, THEN WE OBTAIN SALIVA SAMPLES TO LOOK AT GERM LINE DNA. WE LAUNCHED IN AUGUST OF 2017, SPHEARS THROUGH DIRECT MAIL PEOPLE WE WORKED WITH IN THE OUTCOMES PROJECT AND WE HAVE OVER 170 PATIENTS WHO ENROLLED IN LESS THAN A MONTH TO BE PART OF THE STUDY. TO US THAT MEANS WE'RE CONNECTING WITH THESE PATIENTS AND CONTINUING TO WORK WITH THEM AND WE HOPE TO USE THIS WITHIN THE MOON SHOT AS WELL. ONE OF THE QUESTIONS WE HAVE IS HOW DO WE MAINTAIN THAT ENGAGEMENT OVER TIME. WHAT WE DID WITHIN -- AND WHAT WE HOPE TO DO WITHIN THE MOON SHOT INCLUDING FEEDBACK IS SOCIAL MEDIA. TWITTER FACEBOOK AND YOUTUBE TO REACH PATIENTS. WE DID CONSTANT POSTINGS ONCE A WEEK ON TWITTER AND DEVELOPED EDUCATIONAL VIDEOS THAT WE POSTED ON YOUTUBE, WHAT IS APPEND MOW MA, HOW DO YOU PRONOUNCE IT, TREAT IT, WE INCLUDED PATIENT STORIES PATIENTS SHARED EXPERIENCE OTHER PATIENTS COULD THEN CONNECT WITH. WOVE OVER 600 FOLLOWERS ON TWITTER AND OVER 3,000 FOLLOWERS ON FACEBOOK NOT. OUR WEB PORTAL IS A WAY FOR PATIENTS TO CONNECT WITH EACH OTHER. AND EDUCATIONAL MATERIALS AND WAY TO -- WE SHARE THE RESULTS OF OUR OUTCOMES PROJECT. SO AGGREGATE RESULTS POSTED ON THE WEBSITE, ANY PATIENT THAT WANTS TO SEE WHAT IS THE EXPERIENCE OF APPEND MOW MA PATIENTS THEY CAN ACCESS THAT DATA. FINALLY WE HAVE DONE AWARENESS DAY AND MONTH ACTIVITIES TO CONTINUE BRINGING PEOPLE IN WHO MAY NOT BE AWARE BY EDUCATING THE PUBLIC ABOUT THIS DISEASE. AND HOPEFULLY IMPROVING THE ERICA. FOR PATIENTS GETTING CARE IN THIS COMMUNITY CENTERS. BEFORE WE START ON THAT I WOULD LIKE THE OPEN UP IF THERE'S QUESTIONS WITH WHAT I SHARED SO FAR. >> HOW IS THIS COMPLIMENTARY TO EXISTING WORK BEING DONE IN COG AND HOW DOES THAT WORK TOGETHER WITH INFORMATION AND WITH PATIENT POPULATIONS BECAUSE THERE'S A LOT OF OVERLAP IN THE PEDIATRIC POPULATION? THAT'S ONE OF MY CONCERNS. >> SO IT'S REALLY IMPORTANT TO COLLABORATE WITH PARTNERS. WE HAVE REACHED OUT TO THE CUG, ALSO REACHED OUT TO OTHERS THAT DO ALREADY RESEARCH, LIKE (INAUDIBLE) FOR EXAMPLE TO COLLABORATION WITH THESE GROUPS STUDYING TUMORS OF THE INTEREST. ONE EXAMPLE WE STUDY IN THE CCR, IT IS EXCEEDINGLY RARE. WE DID A STUDY, TWO STUDIES THE WITH CHILDREN'S ONCOLOGY GROUP, THE ONLY PATIENTS INVOLVED WERE COD OPEN WAS AT THE NCI BECAUSE THEY ARE SO RARE. WE ALSO TALKED SO THAT WOULD BE ONE EXAMPLE OF AREAS WHERE WE CAN MAKE A DIFFERENCE. OTHERS ARE RARE TYPES OF SARCOMAS. IT'S POSSIBLE THAT KATIE (INAUDIBLE) NETWORK COLLECTED SOME TUMORS ALREADY. THAT WE CAN ANALYZE AND CONNECT WITH THEM. PEDIATRICS ARE MUCH MORE CONNECTED BUT THERE ARE MUCH TUMORS WHERE THE DISEASES ARE SO RARE THAT DOING CHILDREN'S ONCOLOGY SPECIFIC TRIALS IS NOT GOING TO BE SOMETHING COG WILL DO BUT WE CAN HOPEFULLY PARTNER TO GET PATIENTS THEY CANNOT ENROLL IN THE TRIALS. >> THAT IS TRUE ACROSS ADULT POPULATION AND ONE THING WE DID WITH INSERNA WE HOPE TO EXPAND HERE. NEE DATA WE GENERATE IS HOUSED ON THE CLOUD. PARTNER WITH TUMOR REGISTRIES WE CAN WORK TOGETHER AND DID THAT TOO WHERE WE AND THEY SHARED SAMPLES TO ADVANCE THE KNOWLEDGE. ONE THING SIMILAR IN THE ADULTS IS PEDIATRICS IT IS HARD FOR THE SITES TO KEEP TRIALS OPEN AND ONLY ENROLL A COUPLE OF PATIENTS ON THE TRIAL, THAT WOULD BE FORCED TO CLOSE IT THROUGH IRB. BY HAVING TRIALS WE CAN DO AND BRING PATIENTS HERE WE CAN ADVANCE THE SCIENCE THROUGH THE PHASE 1, 2 SETTINGS AND BRING IT TO THE NETWORKS TO EXPAND WORK. MARK, DID YOU HAVE SOMETHING TO ADD? >> JUST FOR MANY OF THE ADULT RARE CNS CANCERS THERE'S ABSOLUTELY NO ACTIVITY GOING ON OUTSIDE OF THIS EFFORT. IN FACT, THE FIRST PROSPECTIVE CLINICAL TRIAL AND ADULT APPEND MOW MA WAS DONE BY SIRN. SO THE LITERATURE IS A LOT OF ANECDOTAL REPORTS SMALL SERIES FROM INSTITUTIONS WE'RE ABLE TO PULL THAT TOGETHER. IT WAS INFORMATIVE AND IT'S A MAP THAT WE'RE GOING TO USE GOING FORWARD. EXCEPTIONS TO THAT ARE THINGS HIKE HIGHER GRADE MENINGIOMAS WHICH ARE PART OF OUR PLAN AND WE HAVE REACHED TO COLLEAGUES WHO DO THAT RESEARCH. SO SEE IF THERE'S OPPORTUNITY FOR COLLABORATION AND NETWORKING. >> MAYBE ONE MORE POINT. WE ALSO HAVE THE RARE TUMOR CLINICS WE HOLD WHERE WE BRING PATIENTS. THIS WORKS BEST FOR DISEASES THAT ARE NOT RAPIDLY PROGRESSIVE BUT WE BRING PATIENTS AND EXTRAMURAL AND EXPERTS. AND ADVOCACY GROUPS TO NCI TO DO IN DEPTH CLINICAL STUDIES, NOT MUCH DONE IN COG PHASE 1 AND 2 TRIALS LOOKING AT PATIENT REPORTED OUTCOMES AND WE CAN DO IN DEPTH TUMOR STUDIES PATIENT REPORTED OUTCOME STUDIES CLINICAL PHENOTYPING THAT HAVE LED TO SUBSTANTIAL INCREASE IN THE UNDERSTANDING OF THE VERY RARE POPULATIONS. APPROXIMATE EXAMPLE HOW THE CCR CAN MAKE MEANINGFUL CONTRIBUTIONS. >> DID YOU HAVE A QUESTION? >> HOW ARE YOU ENGANGING PATIENTS AND WHERE THERE ANY ADVOCACY GROUPS ESTABLISHED AND WHEN YOU WORK WITH A PATIENT THROUGH THE SERN FOUNDATION IS THERE COMPENSATION FOR TIME AND EFFORT? OUR WORK THERE THERE IS NOT PAYMENT TO PATIENTS WHEN THEY PARTICIPATE THROUGH SERN. WITHIN OUR STUDIES HERE, WE AREN'T PLANNING ON HAVING COMPENSATION TO PATIENTS FOR INVOLVEMENT. IF THAT'S AN ISSUE YOU WOULD LIKE TO TALK ABOUT WE'RE GLAD TO HEAR ABOUT IT. WE DON'T HAVE ESTABLISHED RELATIONSHIP WITH ADVOCACY ORGANIZATIONS. WE ARE WORKING NOW WITH CCR TO UNDERSTAND WHAT WE'RE ABLE TO DO. IN TERMS OF SHARING OF INFORMATION ON THEIR WEBSITES OR SHARING FROM THEIR PORTALS, TO OUR PORTAL, THEN WE'LL REACH OUT TO ADVOCACY GROUPS AN ENCOURAGE THAT RELATIONSHIP. SO THAT IS PART OF THE INITIAL PROCESS WE'RE WORKING ON. >> I DIDN'T MEAN PATIENTS ENROLLED IN STUDY, I MEANT PATIENTS ACTING AS ADVISERS OR PART OF ADVOCACY GROUP. A LOT OF TIMES THEY'RE NOT WELL RESOURCED. AND BEING ABLE TO HAVE SOME TYPE OF FUNDING AND SUPPORT FORE EFFORTS, NOT JEST TRAVEL, AND ACCOMMODATIONS BUT ACTUAL EFFORTS AND PROMOTION. RECRUITMENT AND TRANSLATING MATERIALS INTO LAY LANGUAGE. THAT'S A CRITICAL PART OF IT. I WOULD STRONGLY ENCOURAGE THAT. HAPPY TO GIVE YOU INCITE. THIS IS AN AREA I WORK IN, PERSPECTIVE OF RARE POPULATION THAT IS TRYING TO ENCOURAGE PATIENT ENGAGEMENT IN RESEARCH. THAT IS HELPFUL. >> CIRCLE BACK TO PEDIATRICS. I BELIEVE LAST TIME YOU GUYS GAVE A PRESENTATION, MAY HAVE ASKED THIS QUESTION, YOU MENTION THE PARTNER YOU MENTION IS BOSTON CHILDREN'S HOSPITAL. WHAT ARE YOU DOING TO PARTNER THROUGHOUT COG? I'M SAN ANTONIO WE HAVE ABOUT 250, # HUNDRED PATIENTS IN THE CITY BUT THEY'R SPREAD OUT. VARIOUS INSTITUTIONS AND I THINK MOST PATIENTS ARE NOT GETTING ENROLLED IN THE TUMOR DATA BANKS THINGS LIKE THAT. HOW DO YOU ENVICES, SITES ACROSS COG ARE ACTUALLY LIKE OURS. IT'S NOT HAVE RESOURCE RICH LIKE BOSTON AND TEXAS CHILDREN'S. AND MISSING AN OPPORTUNITY TO GET -- IF WE DON'T CONSIDER THOSE AREAS. >> FROM YOU'RE RAISING THE MOST IMPORTANT QUESTION THAT I HAVE BEEN STRUGGLE WITH, BECAUSE THERE ARE EXAMPLES BUT YOU'RE RIGHT WE NEED TO (INDISCERNIBLE) THAT DO NOT GET TO BOSTON CHILDREN'S OR SAINT JUDE. BECAUSE THOSE WILL BE THE ONES THAT ARE NOT TAKING CARE OF AND BENEFIT FROM THIS. THAT'S EXACTLY WHERE I THINK WE NEED YOUR HELP AND WILL PLAN TO MAYBE MARK CAN COMMENT ON THIS TOO, THAT'S WHAT THEIR EXPERTISE EXPERIENCE SHOWED, THAT'S EXACTLY RIGHT. FROM YOU ARE RIGHT THERE, SOMETHING TO ACCOMPLISH THROUGH OUR OUTREACH EFFORTS. >> I THINK DANIELLE AND I ARE WILLING TO TRY TO GET ADVOCACY COMMUNITY BEHIND IDENTIFYING THESE PATIENTS. EDUCATING POSITIONS IF THERE'S AN OPPORTUNITY. THOSE ARE THE MOST FRUSTRATED PATIENTS REALLY DON'T HAVE A LOT OF OPTIONS. TO GET THE FAMILY WE CAN IMPROVE THEIR -- THOSE SITUATIONS THROUGH RESEARCH. THAT NEEDS TO BE DONE AND THERE'S A HUGE OPPORTUNITY HERE. >> I WOULD VERY MUCH APPRECIATE, WE CAN TOUCH BASE ABOUT THIS EFFORT, THAT WOULD BE WONDERFUL, THANK YOU. >> AS PART OF OUR VARY WE ASK FOLKS WHO DID YOUR SURGERY, WHO ARE YOUR CURRENTLY SEEING FOR FOLLOW-UP AND WE ASK NAMES AND ADDRESSES OF WHO THEY'RE FOLLOWING AND REACH OUT TO THOSE PROVIDERS NOT WITH THAT PARTICULAR PATIENT INFORMATION BUT WE SAY WE SHARE INFORMATION, WE ARE SERN, HUER ARE THE TRIALS AVAILABLE HERE IS WEB-BASED HERE IS OUR PHONE NUMBER. IF YOU HAVE A PATIENT AND HAVE QUESTIONS ABOUT HOW TO PROVIDE CARE, YOU CAN REACH ONE OF THE INVESTIGATORS AND TALK TO THEM. BY REACHING TO THE PATIENT TO REACH THE PROVIDER PROVIDER, I THINK THAT WORKED WELL IN THE ADULT COMMUNITY, IT WAS IMPOSSIBLE -- IT WAS IMPOSSIBLE FOR US TO REACH OUT TO PROVIDERS. WE DID MAILING LISTS FROM THE AMERICAN COLLEGE OF NEUROSURGEONS AND AMERICAN ACADEMY OF NEUROLOGICAL SURGERY, GOT MAILING LISTS AND SENT IT TO TUMOR GROUPS INCLUDING A MAGNET, WE HAD OUR PHONE NUMBER, IF YOU SEE THIS TUMOR CALL THIS NUMBER AND WE CAN HELP BUT BY THAT DIRECT ENGAGEMENT WITH PATIENTS AND DIRECT MAILERS IN CONTACT WITH THOSE PROVIDERS, THAT SEEMED TO WORK VERY WELL. I DON'T KNOW DR. GILBERT IF YOU HAVE ANY THOUGHTS. >> ALWAYS DIRECT COMMUNICATION THAT'S HELPFUL AND ONE OF THE WAYS TO DO I THINK ON MORE GLOBAL SCALE WILL BE THE MODEL WE'RE GOING TO IMPLEMENT WHICH IS HAVE PATIENTS HAVE THE OPPORTUNITY TO COME HERE TO SEE US AT THE NIH THEN WE'LL HAVE THROUGH NETWORK, 26 CENTERS ACROSS THE COUNTRY, IT'S GOING TO INCREASE TO 30. THEY WILL BE THE REGIONAL CARE AND THEN WE HOPE THAT THERE WOULD BE COMMUNICATION BETWEEN THAT NETWORKS PROVIDER AND THE PATIENTS LOCAL PHYSICIANS. THERE ARE THREE PEOPLE OR THREE GROUPS, DON'T WANT TO SAY INDIVIDUAL PEOPLE. SO WE WOULD BE THE CENTER WHERE WE CAN HELP EVERYBODY. BUT THERE WILL BE LOCAL CENTER OF EXCELLENCE PART OF THE NETWORK. THAT CENTER OF EXCELLENCE WILL HOPEFULLY ESTABLISH AND MAINTAIN A VERY GOOD COLLABORATION WITH LOCAL CARE PROVIDER. THAT WOULD BY NETWORK TERMINOLOGY HOPEFULLY GIVE US A HUGE COVERAGE AND BY HAVING MANY CENTERS IN OUR NETWORK GEOGRAPHICALLY DISTRIBUTED ACROSS THE UNITED STATES. WE IDENTIFIED SOME GAPS AND WE WILL FILL THE GAPS, PATIENTS DON'T TRAVEL FAR FOR SPECIALIZED CARE, THEY CAN HAVE MUCH CARE PROVIDED AT HOME BY THEIR LOCAL PROVIDER. IS A MODEL THAT SOUNDS GOOD AND I HOPE AT LEAST ON OUR EXPERIENCE WITH APPEND MOW MA THAT CAN BE VERY SUCCESSFUL. WE ESTABLISHED SOME VERY GOOD RELATIONSHIPS AND RIGHT NOW WE HAVE BECOME THE ADULT APENKAMOMA CENTER FOR THE COUNTRY. SEEING FOUR TO EIGHT APENDAMOMA PATIENTS A WEEK. >> SO DR. ARMSTRONG, I ASSUME YOU'RE GOING TO -- YOU'RE PUSHING US FORWARD TO -- TALK ABOUT WHAT WE CAN DO? OR IS THAT -- >> SO YEAH, SO WE HAVE SPECIFIC QUESTIONS FOR YOU IN TERMS OF THOUGHTS YOU HAVE ABOUT PATIENT ENGAGEMENT AND WE WOULD LIKE TO CONTINUE THE CONVERSATION AFTER THIS WITH PEOPLE WHO ARE INTERESTED. WE APPRECIATE THAT INVOLVEMENT THAT YOU HAVE. BASED ON WHAT WE HAVE SHARED SO FAR, WE WOULD LIKE YOUR OPINIONS OR THOUGHTS ABOUT OUR PLAN FOR ENGAGEMENT. OUR PLAN IS TO REACH THE PATIENTINGS USE, SOCIAL MEDIA OR PLAN TO RESOURCES, PLAN TO REACH OUT TO NETWORKS OF CARE PROVIDERS WE KNOW EXIST. WE HAVE QUESTIONS ABOUT THAT, THAT HAVE BEEN PROBLEMS IN THE PAST. UNDER-REPRESENTED POPULATIONS ARE WE REACHING THEM OR ANOTHER AVENUE TO CONSIDER FOR THAT. FOR THE ADOLESCENT AND YOUNG ADULT POPULATION, THAT'S A GROUP THAT DOESN'T PARTICIPATE WELL IN CLINICAL TRIALS. ANY THOUGHTS OR ADVICE THAT YOU HAVE FOR US RELATED TO THAT? AND ALSO THESE LAST REPRESENT -- LESS REPRESENTED AREAS OF THE COUNTRY AS WELL. ANY GUIDANCE OR THOUGHTS FROM YOUR EXPERIENCE TO ADVISE US, WE WOULD APPRECIATE THAT. >> >> HI. MY NAME IS ROBERTO, NOT SURE MORNING OR AFTERNOON, I'M ON WEST COAST TIME. THANKS FOR THE PRESENTATION. I WOULD LIKE TO SUPPORT COMMENTS MADE BY SUE EARLIER WITH REGARD TO PROVIDING RESOURCES THAT SUPPORT PARTNERS THAT REACH POPULATIONS UNDER-REPRESENTED. IT'S CHALLENGING FOR ME TO WRAP MY HEAD AROUND THE BEST APPROACH WHEN LOOKING AT SUCH A SMALL POPULATION. BUT WHAT WE FOUND IN THE BAY AREA, BY PARTNEING WITH THOSE ORGANIZATIONS THAT ARE UNDERTO BE TRUSTED ADVOCATES FOR POPULATIONS UNDER-REPRESENTED, I'M THINKING ONE EXAMPLE, WE'RE OUT OF THE UCSF CANCER CENTER, FOLKS SPENT YEARS DEVELOPING STRONGER RELATIONSHIPS WITH AFRICAN AMERICAN CONGREGATIONS ACROSS THE BAY AREA. AND REALLY INVESTING TIME AND BUILDING THOSE RELATIONSHIPS AND GETTING TO A PLACE WHERE THEY FEEL THAT IT IS BEGINNING TO BARE FRUIT AND FOLKS IN THE AFRICAN AMERICAN COMMUNITIES ACROSS THE BAY AREA AS A RESULT OF THOSE -- THAT RELATIONSHIP BUILDING, ARE MUCH MORE ANTICIPATION AND EXPECTATION AS WE EXPAND THE NUMBER OF DISEASES, WE LOOK AT WE HAVE SIMILAR SUCCESS. >> I'M NOT AN EPIDEMIOLOGIST. I ASSUME YOU'RE PARTNERING WITH FACT STUDY IS GOING TO GIVE INCITES INTO SOME OF THE QUESTIONS YOU'RE ASKING SUCH AS AWARE THESE PATIENTS FOR THE HEALTHCARE SYSTEM. WHERE ARE THEY POPPING OFF? WHAT KIND OF DIAGRAM OR WHAT KIND OF VISUAL IS THAT GOING TO GIVE YOU BECAUSE I THINK AS YOU MOVE FORWARD THROUGH THE DIFFERENT RARE TUMORS AND SELECTED TEN, THAT THAT IS GOING TO BE INFORMING YOU TO ANSWER SOME OF THESE QUESTIONS, IS THAT CORRECT? >> ABSOLUTELY. WITHIN THE OUTCOMES SURVEY WE ASK THOSE QUESTIONS TO TRY TO UNDERSTAND THAT. WE HAVE WORKED WITH MELISSA BONN DIAND KERRY TO DESIGN RISK-BASED SURVEY WHERE WE ASKED ENVIRONMENTAL EXPOSURE QUESTIONS AS WELL. SO WE'RE BUILDING ON THE WORK THEY HAVE THEY HAVE ALREADY DONE. AND APPLYING TO IT THE CNS TUMORS AN ADVANCE TO THE PEDIATRIC TUMORS AS WELL. WE LEARNED SO MUCH FROM EXACTLY THAT AND IN TERMS OF HOW LONG IT TAKES TO BE DIAGNOSED. THOSE ARE ISSUES WE THINK DON'T APPLY TO THE UNITED STATES BUT AT LEAST THE SPINAL CORD TUMORS MOST PATIENTS WERE SYMPTOMATIC FOR A YEAR BEFORE HAVING DIAGNOSTIC IMAGING SO WE LEARNED A LOT THAT WE THEN NEED TO TRY TO INFORM FAMILY SIGNATURES WHOSE MAY NOT BE SEEING THE PATIENTS TO BEGIN WITH. DEFINITELY QUESTIONS EXACTLY THAT WITHIN THE OUTCOMES TO TRY TO UNDERSTAND PATTERNS AND WHAT WE'RE SEEING AND WHAT WE NEED TO EDUCATE ON. AND WHAT QUESTIONS WE NEED THE ASK AND FOLLOW-UP. SO WITH WITHIN THE OUTCOMES SURVEY, THAT'S WHAT HAPPENED WITH THE OUTCOME SURVEY WE KNEW WE HAD TO ASK OTHER QUESTIONS, LIKE NUMBER OF FOLKS NOT ABLE TO WORK. DID THEY HAVE TO CHANGE THEIR POSITION. BECAUSE OF NEUROLOGIC DEFICITS. IT HELPED US UNDERSTAND WHAT WAS HAPPENING WITH THAT POPULATION. IT WILL CONTINUE TO BE AN ITERATIVE PROCESS, ALL THESE TUMORS ENTERING NOT KNOWING THE ANSWERS, MAYBE DIFFERENCE THAN WE THINK. LIKE WE LEARNED FROM APPEND MOW MA. >> THAT'S WHY WE HAVE A RARE CANCER COMMITTEE. WE HAVE A SPECIFIC TRIAL FOR RARE CANCERS, THE DART TRIAL WHICH YOU MAYBE -- IT'S A SMALL WORD YOU GUYS ALREADY KNOW THIS. BUT I CAN TELL YOU SHE'S EXTREMELY WELL CONNECTED YOU PROBABLY ALREADY KNOW THAT. SHE HAS A PATIENT ADVOCATE EXTREMELY WELL CONNECTED. AND BETWEEN THE TWO OF THEM THEY CAN -- IF YOU HAVEN'T REACHED OUT WE'LL BE WORKING WITH HER. I THINK THEY CAN BE E TREATMENTLY HELPFUL TO YOU ARE YOU CAUSE. SO I KNOW -- VERY WELL, WE WORK AT M D ANDERSON IN THE PAST LIFE AS YOU WOULD SAY. I KNOW ABOUT THE PROGRAM. I THINK THEIR RARE CANCER INITIATIVE EXCLUDES CNS. SO -- >> YOU MEAN SPECIFICALLY THE DARK -- >> I THINK THERE WOULD BE TREMENDOUS OPPORTUNITY WHEN UP AND MOVING. BUT THEY ALSO -- SO I UNDERSTAND THE POINT ABOUT THE EXCLUSION. BUT IN TERMS OF THE NETWORK AND THE PROCESS, I CAN TELL YOU MARSHA AND RIZ ACTIONLL WOULD BE EXTREMELY HELPFUL AND INSIGHTFUL TO YOUR CAUSE. >> I WAS GOING TO SAY THEY WOULD BE PERFECTLY COMPLIMENTARY BECAUSE NO OVERLAP, BUT YET SAME TYPE OF CHALLENGES. >> YOU ALREADY KNOW RIZELL BUT DO YOU NEED -- IF YOU NEED HELP FROM MY SIDE. >> APPRECIATE IT. >> SHE'S IN SAN DIEGO. >> THANK YOU SO MUCH. I KNOW WE HAVE LIMITED TIME BUT SOME THINGS BROUGHT UP IT WOULD BE NICE TO DELVE INTO MORE. WHAT WOULD ADVOCACY NEED OR WANT FROM THE PARTNERSHIP. SO RIGHT NOW WE HAVE A PLANNED LIAISON WORKING WITH ADVOCACY, TO DEVELOP ACTUALLY A RELATIONSHIP IN WHICH THEY'RE ABLE TO SHARE WHAT WE'RE DOING BUT WE'RE ALSO ABLE TO SHARE WITH ADVOCACY GROUPS ARE DOING. ONE STOP SHOP RARE CANCER, WE NEED TO REFER OUT TO THESE COMMUNITIES AS WELL. THERE'S SOME TALK ABOUT RESOURCES, I WONDER IF YOU WOULDN'T MIND EXPANDING ON WHAT THAT MEANS. IN OUR MINDS WE WERE THINKING WE NEED TO HAVE MEETING WITH ADVOCACY GROUPS, WE BRING THEM HERE AND SEEING WHAT AND UNDERSTAND WHAT WE'RE DOING AND GET ADVICE OR REVIEW MATERIALS THAT WE HAD. OR IS IT SOMETHING DIFFERENT. ADVOCACY GROUPS WOULD NEED. >> THAT'S A GREAT QUESTION, IT DEPENDS ON THE GROUP, THERE'S AN ASSUMPTION IT'S PART OF OUR MISSION SO THEREFORE WE NEED TO SUPPORT IT BUT MOST OF US ARE UNDERRESOURCED AND UNDERSTAFFED SO WHAT IT MEANS IF YOU'RE ASKING FOR VOLUNTEERS WE TRAIN ADVOCATES, WE GO OUT AND REVIEW MATERIALS SO THAT IT DEPENDS LIKE AN ORGANIZATION LIKE OURS WE HAVE A MENU. THIS IS THE TIME IT TAKES, THESE ARE THE RESOURCES AND THIS IS THE COST. THAT MAKES IT EASIER BECAUSE THERE ARE FIXED COSTS ASSOCIATED WITH IT. A LOT OF START UP GROUPS AND SMALLER GROUPS DON'T HAVE THAT SO THEY JUST DO IT AND THEY DO IT IN SO MANY DIFFERENT PLACES. SOON THEY WHERE YOU KNOW OUT OF BANDWIDTH IN ONE WAY. IT'S NOT JUST THE TRAVEL HERE AND IT'S A GREAT EXPERIENCE TO COME AND REVIEW AND HAVE A CHANCE TO LOOK AT THE CAMPUS AND TALK TO SCIENTISTS, IT IS COMPENSATION FOR THEIR TIME. SO USUALLY THERE'S DEPENDS ON PERSON AND ADVOCATE AND WHAT THEY DO IN REAL LIFE OR IF THEY'RE FULL TIME ADVOCATE. THAT COULD BE A CONVERSATION TO HAVE WITH THEM. SO IS IT'S THAT STUDY PROMOTION AND RECRUITMENT, THOSE ARE MENU ITEMS, THEY HAVE RESOURCES BECAUSE WE'RE MANAGING A DATABASE. IF WE FIND THOSE ADVOCACY GROUPS MY SUGGESTION IS TO HAVE TO HELP THEM GET GOOD ADVISORY BOARD MEMBERS THAT ARE TOP SCIENTISTS THAT WANT TO WORK WITH THEM TO MAKE SURE THAT EVERYTHING THEY PROMOTE AND ALL THE MATERIALS THAT THEY PUSH OUT TO THE COMMUNITY ARE EVIDENCE BASED AND BALANCED. THAT PERSON CAN BE THE LIAISON BETWEEN THEM AND YOU. SO IF YOU THINK MAYBE THERE'S SOMETHING THAT HAS HAPPENED WITHIN THE IMMUNITY AND IT'S INAPPROPRIATE OR SOMEONE WITH AGENDA AND THEY'RE SPEAKING VERY LOUDLY, AND REALLYNOMWITHOUT EVIDENCE, THAT YOU CAN INVOLVE THE ADVISORY BOARD MEMBER TO HAVE A CONVERSATION WITH THEM. AND STILL RESPECT THEIR CULTURE TOO. THAT WAS A LOT. >> FOR MANY ADVOCACY ORGANIZATIONS, HOW THE COMMUNICATE THE PARTNERSHIP, THAT -- HOW THEY CAN PROMOTE WHETHER A THEY'RE DOING AND PARTNERSHIP WITH YOU, THAT CAN BE A GREAT BENEFIT TO THE ADVOCACY GROUP. HOW WE VET ADVOCACY GROUPS WORKING WITH EXISTING COALITIONS, ESPECIALLY IN THE PEDIATRIC CANCER SPACE, YOU CAN PISS OFF A LOT OF PEOPLE IF YOU CAN CHOOSE ONE OFF ANOTHER. THERE ARE MULTIPLE WE CAN TALK ABOUT THAT IN SOME WAYS SO IT'S IMPORTANT TO BEEN COLLUSIVE. TALKING ABOUT A SPECIFIC DISEASE AND GROUP OF DISEASES AND MAKING SURE THERE'S ENOUGH PEOPLE WORKING WITH THE COALITIONS CAN BE VERY HELPFUL AND HELPING IDENTIFY SOME OF THOSE GROUPS. >> SO WE KNOW THAT THERE ARE A LOT OF ADVOCACY GROUPS. AND THIS WE IS ACTUALLY TO HELP US WHAT WE HAVE BEEN INSTRUCTED SO FAR IS THAT WE HAVE TO HAVE AN OPEN PROCESS WHERE ANY GROUP THAT CALLS HIMSELF AN ADVOCACY GROUP IN OUR RESPECTIVE SPACES IS ALLOWED TO APPLY, WE DON'T KNOW -- WE CAN NEVER ENDORSE, THAT'S OFF THE TABLE BUT WE CAN LINK OR SOMETHING I DON'T WANT TO SAY TOO MUCH BECAUSE I REALLY DON'T UNDERSTAND. BUT WHAT QUESTIONS SHOULD WE ASK IN THIS? BECAUSE WE OBVIOUSLY -- IT'S CUMBERSOME, IT'S NOT POSSIBLE TO -- FROM THE PEDIATRIC SPACE FOR DR. WIDEMANN AND HER PART OF THE PROGRAM TO BE ENGAGING A THOUSAND ADVOCACY GROUPS. SO WHAT ARE THE CRITERIA BY WHICH YOU THINK WOULD BE FAIR FOR US TO MEASURE WHICH ONES? NOT SAYING THE ONES THAT DON'T QUALIFY AREN'T GOOD, JUST NOT APPROPRIATE FOR WHAT WE'RE TRYING TO ACCOMPLISH. THAT'S WHAT WE'RE STRUGGLING WITH. THERE'S SOME BRAIN KAREN WHAT IS ARE NO BRAINERS PUN INTENDED. >> BUT THERE ARE OTHERS THAT WE DON'T KNOW THEM BUT THEY MAY COME FORTH THEY SEE THIS AS AN OPPORTUNITY MUTUALLY BENEFICIAL, AND THERE ARE OTHERS THAT, WE WON'T BE HELPFUL TO THEIR MISSION AND NOT HELPFUL TO OUR MISSION. HOW DO YOU FIND THAT OUT? WITHOUT ACTUALLY GETTING INTO THAT COLLABORATIVE RELATIONSHIP AND FINDING OUT THAT IT'S NOT SUCCESSFUL. >> I SUGGESTED TIERED APPROACH APPLICATION PROCESS AND MAYBE WHEN YOU'RE HAVING THOSE MEETINGS THAT ARE ADVOCATES AND SCIENTISTS IT GIVES YOU THE ABILITY TO HAVE FACE TIME WITH THAT AND SEE WHAT THEIR COMMITMENT IS AND COMPENSATION DOESN'T HAVE TO BE AT THE BEGINNING. THEY RISE TO THE SURFACE AND WANT TO BE PART OF STUDY DESIGN EVEN POTENTIALLY BUT I THINK THAT LOOKING ON THIS WEBSITE AND LOOKING AT NEWS AND IT'S A CRN MEMBERS ARE A COLLABORATIVE NETWORK OF RESEARCHERS AND MEDICAL PROVIDERS WHO ARE CONSTANTLY MAKING NEW DISCOVERIES MAKE THEM PART OF THAT. ALLOW THEM TO BE PART OF STUDY DESIGN, MAYBE THEY HAVE PROs THEY'RE INTERESTED IN. IF YOU TIER IT YOU WILL HAVE A SENSE OF WHO IS MOST COMMITTED AND WHO IS MORE SCIENTIFICALLY OR YENNED AND ALLOW IT TO BE A LITTLE BIT FLEXIBLE. IT SOUNDS LIKE YOU MAY NOT HAVE THAT FLEXIBILITY ON YOUR END. >> YOU WANT SOME ADHERENCE TO YOUR MESSAGING. SO ADVOCACY GROUPS DON'T OVERSTATE WHAT YOU'RE GOING TO DO OR MISSTATE PARTICULARLY WITH PATIENTS AT STAKE. SO SOME WAY THE NCI ANOTHER EXAMPLE, THERE'S OTHER SITUATIONS WHERE ADVOCATE GROUPS PARTNER WITH NCI TO GET MATERIALS OUT TO STICK TO MESSAGING. >> JUST TO TACK ON, IT'S SUPER HELPFUL TO GET COMMENTS AROUND THE TABLE ABOUT CRITERIA FOR ADVOCATE ENGAGEMENT, I HEARD YOU ABOUT TIERING IT AND PRIORITIZING. THIS IS VERY MUCH THAT THE OFFICE DOES PLAY WITH OUR SCIENTIFIC LEADERSHIP CLINIC AND THE COMMUNITY. WHERE WE ARE A FRONT DOOR FOR THE ADVOCACY COMMUNITY, WE HAVE RELATIONSHIPS WE'RE ALWAYSING NEW RELATIONSHIPS AND WE CAN FACILITATE THIS PROCESS. WHERE WE UNDERSTAND THE ORGANIZATIONS DO AND DON'T AND WHICH MIGHT BE BETTER TO PARTNER WITH, IN GENERAL IT IS IMPORTANT TO COMMUNIQUE WITH EVERYONE AS AN ENTIRE COMMUNITY AND THEN AND SEE WHO SELF-SELECTS TO PARTICIPATE. WHO MAYBE DOING IMPORTANT WORK BUT DOESN'T PARTICULARLY RELATE TO RARE TUMOR NETWORK. THAT'S A ROLE THAT ADVOCATES OFFICE ON BEHALF OF ALL OF YOU AS THIS GETS OFF AND RUNNING. >> GREAT. THANK YOU SO MUCH. FINAL SET OF QUESTIONS AND ANY COMMENTS THAT YOU WANT TO SHARE ABOUT HOW TO FOSTER THE RELATIONSHIP WITH PATIENTS AS WE GO FORWARD. HOW BEST THE PROVIDE THAT KIND OF VIRTUAL SUPPORT FOR PATIENTS AND MAINTAIN COMMUNICATION. IS IT THROUGH DIRECT MAIL OR DIRECT EMAIL COMMUNICATION, DO YOU THINK THAT NEWS LETTERS ARE AN APPROPRIATE WAY TO COMMUNICATE? DO YOU THINK THAT WE NEED TV SCHEDULED PATIENT STORIES OR INVITATION FOR PEOPLE TO SHARE THEIR MESSAGE WITH OTHER FOLKS, ANY ADVICE FROM YOUR EXPERIENCE ABOUT FOSTERING THAT RELATIONSHIP AND CONTINUING THAT COMMUNICATION WOULD BE WELCOME. >> REALLY IMPORTANT WHATEVER YOU'RE DOING IS COMPLIMENTARY, I THINK YOU'RE GOING TO FIND YOUR AD HAVE SHY GROUPS ARE DO -- ADVOCACY GROUPS ARE DOING THIS ALREADY. IT'S LIKE YOU HAVE TO LOOK AT THIS ON A CASE-BY-CASE BASIS AND DEFINE VALUE PROPOSITION THAT WORKS FOR THE INDIVIDUAL GROUP BECAUSE SOME OF THEM BELIEVE YOU'RE DISPLACING THEM. THAT WON'T BE NECESSARILY A GOOD THING. OTHERS WILL WANT SPECIFIC ITEMS IN YOUR -- CALL IT A CAFETERIA OF CHOICES. AND THAT WILL BE GOOD. >> MY COMMENT WAS CLOSE TO I THINK AMY WHERE YOU WERE GOING, I'M NOT SURE YOU NEED TO WORRY ABOUT TAKING AND SELECTING THE GROUPS. MAKE THIS OPEN. THE STARS WILL RISE TO THE TOP. THEY ALWAYS DO. THERE WILL BE PEOPLE DOING ABSOLUTELY NOTHING, THAT'S FINE BUT THEY CAN GET COMMUNICATION, YOU DON'T NEED TO PUSH THEM OFF THE ISLAND. STARS RISE TO THE TOP, AND THOSE WILL BE THE ONES THAT AUTOMATICALLY WILL ENGAGE IN, AND OBVIOUSLY BASIC RESEARCH REALLY BASIC SO NON-PROFIT ORGANIZATIONS, THEY HAVE 501C 3 ORGANIZATION, NOT INDIVIDUAL, THESE ARE KIND OF BASIC BUT I DON'T KNOW. MY THOUGHTS ARE BEYOND THAT. >> SO YOU THINK IT WILL BE BINARY? I'M JUST CONCERNED THAT IT WON'T QUITE BE BINARY, THERE'S A GROUP IN THE MIDDLE. PRETTY E S I TO INVITE ONE GROUP AND THEY'RE SORT OF NOT GET INVITED AND CREATE -- >> WHEN YOU SAY INVITED >> SO PART OF THIS IS HOW DO WE CONNECT TO THESE GROUPS AND WE'RE TOLD, I DON'T KNOW IF IT'S OFFICIAL YET. BUT WE CAN ACTUALLY PUT GROUPS LOGOS ON OUR -- WHEN WE HAVE OUR WEBSITE AND OBVIOUSLY THE EXPECTATION IS THAT THEY WOULD REFER TO OUR PROGRAM ON THEIR WEBSITE, WE HAVE NO CONTROL OVER THAT. THEN IF WE DON'T INCLUDE SOMEBODY BECAUSE THEY DIDN'T RISE TO TOP AND THEY TAKE A DIM VIEW OF THAT, DO WE REALLY WANT TO GET CAUGHT IN SOCIAL MEDIA WARS? I UNDERSTAND, I DON'T PARTICIPATE IN THOSE. I'M HOPING YOU'RE RIGHT. I HOPE IT'S REALLY EASY BUT I DON'T KNOW. I THINK GROUPS SOMETIMES GROUPS PERCEPTIONS OF THEIR WHERE THEY STAND MAYBE DIFFERENT THAN OTHER PERCEPTIONS. >> I TOTALLY UNDERSTAND WHERE YOU'RE COMING FROM. I THINK THERE ARE SITUATIONS WHERE THAT HAPPENED HISTORICALLY. I THINK THAT WE CAN FACILITATE THAT, THE ADVOCACY OFFICE CAN HELP IN THOSE DISCUSSIONS AND LARGELY YOU GET AROUND THAT BY BEING INCLUSIVE AT THE BEGINNING AND COMMUNICATING WITH ENTIRE COMMUNITIES. SOME WILL SELF-SELECT TO PARTICIPATE AND OTHERS WILL NOT. AS THAT EBB AND FLOW IS HAPPENING, IF YOU KEEP COMMUNICATION CHANNELS OPEN, THAT HELPS WITH THAT. CERTAINLY WHEN IT COMES TO BEING SPECIFIC ABOUT LOGOS, COMMUNICATIONS OFFICE AND WORK CLOSELY TOGETHER TO HELP PROGRAM STAFF WITH THAT. BUT I DON'T THINK WE NEED TO FOCUS ON THAT SO MUCH THAT IT DICTATES OUR BEHAVIORS. WE COME UP WITH A PLAN WE REACH OUT BROADLY. WE KEEP LINES OF COMMUNICATION OPEN AN STARS WILL RISE, THOSE THAT ARE MOST APPROPRIATE AND THOSE WHO ARE NOT PARTICIPATE ON THAT LEVEL, WE COMMUNICATE WITH, THAT'S FINE BUT I THINK THE ADVOCACY COMMUNITY HAS EVOLVED A LOT IN THE PAST FIVE TO TEN YEARS, EVEN SO THEY'RE SAVVY, THEY KNOW WHAT HATS TO WEAR AND HOW TO ENGAGE IN THE COMMUNITY AND THEY HAVE A PLAN. WE SEE LESS OF THAT NOW. BECAUSE OF HOW PROFESSIONAL AND SAVVY THEY R. >> AND THE GOAL IS TO GET MORE PATIENTS TO YOUR PROGRAM. SO KEEP THAT ON YOUR FOREFRONT. YOU'RE GOING TO HAVE COUPLE OF BAD SEEDS BUT THAT'S FINE. THEY'LL GO AWAY. IT WILL BE FINE. BY INCLUDING WORK YOU'RE GO FOG GET TO (INAUDIBLE). >> HILLED ENCOURAGE YOU THE SHARE AS MUCH DATA AS YOU'RE ALLOWED TO AND CAN. IT CAN SEEM TO BE LIKE MINUSCULE BUT SHARING BAKE TO PATIENTS WE SENT OUR THESE SURVEYS AN 132 OF YOU RESPONDED AND 50 OF YOU GAVE US THE NAMES OF YOUR PHYSICIANS AND WE CONTACTED THEM AND OF THEM, 32 RESPONDED THAT TYPE OF THINKING THAT LEVEL OF DETAIL MAKES PEOPLE FEEL ENGAGED. SO I DO THINK A NEWS LETTER AND BEING ABLE TO PROVIDE WHATEVER FACTOID ABOUT THE RESEARCH THEY SHARED WITH YOU, BACK TO THEM, IS REALLY HELPFUL. AND ENGAGING. >> BACK TO REASONING'S POINT, IF WE CAN -- AS A NON-PROFIT IF WE CAN FRAME WHAT YOU'RE DOING, MAYBE SOMETHING WE CAN'T DO. IN A SENSE EXTENDING OUR CAPACITY. TO HELP PEOPLE, THAT'S A GREAT THING. SO IS IT'S A WIN FOR YOU AND A WIN FOR A NON-PROFIT. >> LOOK AT SPECIFIC NICHE GROUPS. WE'RE LOOKING AT THE WHOLE BRAIN TUMOR COMMUNITY, IF YOU'RE DOING SOMETHING THAT HELP AS SUBGROUP AND THEY CAN LATCH ON TO THAT, AND THAT'S HELPFUL, THAT'S A WIN. >> THE TERM PARTNERING BECOMES REALLY IMPORTANT BECAUSE THEN IT SEEMS LIKE IT'S AN EQUAL RELATIONSHIP AFFILIATED WITH OR CONNECTED TO. OR WILLING TO PUT ACTUAL PARTNER. THAT'S THE SUCCESS OF THIS IS GOING TO BE PREDICATEDDED ON OUR PARTNERSHIP WITH ADVOCACY. >> AND FRANKLY THE BULK OF MY WORK MUCH MORE THAN ADVOCACY IS AROUND HELPING TO FACILITATE PARTNERSHIP BETWEEN SCIENTISTS AND COMMUNITY. AND THERE'S TREMENDOUS FIELD AROUND THAT. AND SCIENCE AND ART AROUND HOW TO DO THAT AND I CAN SHARE MORE RESOURCES AROUND THAT OFFLINE. DR. IS AN INTERNATIONAL ORGANIZATION THAT SUPPORTS THAT TYPE OF WORK. SO I CAN SHARE RESOURCE AROUND CONCEPTS THAT BUILD RELATIONSHIPS BETWEEN THOSE COMMUNITIES. >> JUNE, REGINA, WANT TO MAKE SURE YOU WANT TO WEIGH IN. >> YOU GUYS HAVE BEEN HAVING A GREAT DISCUSSION, I HAVE BEEN FOLLOWING IT AND SOUND LIKE YOU GOVERNED THE GAMUT OF THINGS TO RECOMMEND. >> THANK YOU. ANYONE IN PUBLISH? >> OKAY. >> WHY DON'T WE THANK DR. ARMSTRONG, GILBERT AND WIDEMANN. THIS GROUP, THIS IS NOT THE LAST OF THE CONVERSATIONS, OBVIOUSLY, THIS IS THE BEGINNING AND WE LOOK FORWARD TO PARTNERING WITH THIS -- WITH THIS INITIATIVE AS NCRA. >> THANK YOU SO MUCH. >> APPRECIATE YOUR FEEDBACK AND YOUR TIME. THANK YOU. >> SO WE WILL TAKE A QUICK BREAK NOW. WE'LL GIVE EVERYBODY 15 MINUTES, IT IS 35 AFTER SO WE'LL COME BACK AT 11:15 AND START WITH THE NEXT SESSION. THIS IS THE NEXT SECTION HERE LEADING UP TO LUNCHTIME IS AN OPPORTUNITY TO DISCUSS MORE OF A GLOBAL ISSUE IN PRECISION MEDICINE CLINICAL TRIALS FROM THE PATIENT ADVOCACY PERSPECTIVE PATRICK WAS KIND ENOUGH TO SEND OUT A IMPORTANT ARTICLE FROM THE NEW YORK TIMES FROM AUGUST AROUND SUBJECT OF PRECISION MEDICINE CLINICAL TRIALS, THE ARTICLE ADDRESSED COUPLE OF BIG ISSUES. ONE IS DO WE HAVE TOO MANY TRIALS FOR TOO FEW PATIENTS IN THE ERA OF MOLECULAR MEDICINE. THE SECOND ISSUE HOW TO DO DRUG PRIORITIZATION WHEN THERE ARE MULTIPLE AGENTS FOR EXAMPLE ANTI-PD 1s AND HOW DO WE PRIORITIZE THOSE AGENTS TO INTO TOO FEW CLINICAL TRIALS IN SOME WAYS TOO MANY AGENTS. SO WHO GOES FIRST. BUT THE BIGGER ISSUE IS REALLY IF THERE ARE A LOT OF TRIALS AND NOT ENOUGH PATIENTS, HOW DO WE KEEP CLINICAL RESEARCH GOING FORWARD AS WE GET SMALLER GROUPS, THE PATIENTS ARE HARDER AND HARDER TO FINE. THE ARTICLE INTERESTINGLY QUOTED THE INCOMING NCI DIRECTOR, DR. SHARPLESS SAYING THE ERA OF 700 PATIENT PHASE 3s MAYBE OVER AND WE'RE NOW DOWN TO MUCH SMALLER GROUPS. THAT'S ALSO CONSISTENT WITH THE DIRECTION THE FDA COMMISSIONER SAID A FEW WEEKS AGO, WE DON'T NEED AS MANY PHASE 3s ANY MORE. WE NEED -- WE CAN APPROVE THINGS AFTER PHASE 1 AND 2 WITH CLINICAL BENEFIT AND STRONG SAFETY PROFILE SO WE'RE MOVING THE ERA OF SMALLER AND HOW THE FIND THOSE PATIENTS. HOW DO WE AS CANCER CELL ADVOCACY LEADERS GET OUR HEAD AROUND CHANGE IN LANDSCAPE OF MIDDLE EARTH AND IN DOING SO EDUCATE THOSE WE WORK WITH AND GET OUR ORGANIZATIONS AND HOPEFULLY HELP OUR PATIENT COMMUNITIES GET STRUCTURED TO MORE FULLY AND MORE ROW ROBUSTLY PARTICIPATE IN PRECISION MEDICINE. SO THAT'S THE BIG ENCHILADA OF THE TOPICAL QUESTION. WE WROTE DOWN SOME FACILITATED QUESTIONS HERE TO GET GOING BUT WANTEDDED TO STOP THERE AND SEE IF OTHERS, IF THIS TOPIC RESONATES WITH YOU, IF IT'S BEEN OUR YOUR MIND AS WELL. IT'S CERTAINLY BEEN ON OUR MIND AT NATIONAL BRAIN SOCIETY BECAUSE WE HAVE MANY PATIENTS IN THESE SMALL RARE DISEASES WE'RE WORRIED ABOUT THEM GETTING INTO THE RIGHT TRIALS FOR THEM. SO STOP THERE AND JUST OPEN IT UP. >> I WANTED TO NOTE THAT NCI PLAYS A LOT OF ROLES WITHIN THE CANCER COMMUNITY, ONE IS TO ACT AS CON VIE NOR. AND WHILE WE DECIDED THE TALK ABOUT THIS TODAY, WHILE WE HAD Y'ALL IN THE SAME ROOM. THIS IS NOT TYPICAL DISCUSSION WE HAVE WITH THESE MEETINGS BRINGING IN NCI SCIENTIST OR HIGHLIGHT A PROGRAM. THIS IS NOT REALLY -- THIS DISCUSSION IS NOT NCI FOCUSED. WE WANTED TO INSTEAD BRING TOGETHER ALL OF YOU AND HAVE A DISCUSSION WITH ADVOCATES ABOUT PATIENTS. AND YOUR CONSTITUENTS AND HOW YOU FEEL LIKE YOU CAN CONTRIBUTE TO THIS AND FOR US TO HAVE AN OPPORTUNITY TO HEAR THAT AND WORK TOGETHER. THIS IS DIFFERENT FROM THE OTHER PRESENTATIONS THAT WE HAVE IN THAT THIS IS A REAL ADVOCACY ISSUE AND TRY TO ACT AS CONVENER WITHIN THE IMMUNITY FOR THE BENEFIT OF PATIENTS AND KEEPING DISCUSSION GOING AND HOPEFULLY SEEING PEOPLE WORK TOGETHER IN DIFFERENT WAYS. >> TWO THINGS THAT I WANT TO SAY, AT FORCE WE THOUGHT ABOUT THIS A LOT. AT A TIME ABOUT LITTLE OVER A DECADE AGO WHEN PARP INHIBITORS WERE FIRST DEVELOPED FOR BRCA, CANCERS, SOON AFTER THOSE FIRST CLINICAL TRIALS STARTED THERE WAS A NEW APPROPRIATION FOR TRIPLE NEGATIVE BREAST CANCERS THEN THERE WERE ALL OF THESE TRIPLE NEGATIVE TRIALS SHOWING UP, AND THE UPSHOT OF THAT, THERE'S MORE TRIPLE NEGATIVE BREAST CANCER SURVIVORS THAN BRCA MUTATION SURVIVORS, THERE WERE MORE CLINICAL TRIALS ENROLLING PEOPLE BUT THERE'S OVERLAP. IT'S A CHALLENGE BECAUSE WE WANTED THE TRIPLE NEGATIVE STUDIES SUCCEED. AT THE SAME TIME THEY WERE COMPETING WITH PATIENTS THAT WRE FOR SMALLER CLINICAL TRIALS THAT WERE REALLY SPECIFIC TO COMMUNITY WHICH WAS BRCA, SO A SMALLER SUBSET OF A LARGER -- EVEN A LARGER SUBSET OF A LARGER DISEASE STATE MEANT A LOT OF CLINICAL TRIALS PULLING FROM THIS POTENTIAL VERY, VERY SMALL FOR THE PEOPLE. I WANT TO ADD ANOTHER THING TO THE CONVERSATION. THIS CAME UP RECENTLY. AFTER OVER A DECADE WE SAW THE FIRST PARP INHIBITOR FOR O VARY I CAN'T UNDERSTAND CANCER TREATMENT, TREATMENT, FOLLOWED BY TWO MORE. RECENTLY, THERE WAS ICER CONVENED THIS MEETING ABOUT COST EFFECTIVENESS. FOR ALL INTENTS AND PURPOSES LOOKS LIKE THEIR GOAL IS TO GIVE PAYERS A REASON NOT TO REIMBURSE FOR THESE DRUGS. I ALSO WORRY POST CLINICAL TRIAL, WE HAVE DONE A LOT OF MESSAGING ABOUT THESE ARE NEW DRUGS, TARGETED, THEY OTHER FOR OUR COMMUNITY AND THOUGH AT THE END OF THE DAY THEY'RE NOT ONLY BEING USED ADS TARGETED THERAPIES, IF AT THE END OF ALL OF THAT AND OVER A DECADE OF RESEARCH AND RECRUITMENT AND GETTING THOSE CLINICAL TRIALS DONE, IF PATIENTS CAN'T GET ACCESS TO THE DRUGS, IT IS A DISINCENTIVE FOR THE COMMUNITY TO PARTICIPATE FOR BIOTECH COMPANIES TO DEVELOP THE DRUGS. I'M CONCERNED ABOUT THAT POST RESEARCH ACCESS TO CARE AT THE SAME TIME. TOO. >> THAT'S HELPFUL, SUE. WHAT I'M STARTING TO DO THROUGHOUT THIS CONVERSATION IS WRITE DOWN PATIENT ADVOCACY ISSUES IN THIS ISSUE SPOTTING. AS WE GO ALONG. UNFORTUNATE WHAT LAWYERS DO HALF THE TIME. JULIE. >> I THINK THIS WHOLE AREA TO ME IS FORCING PATIENT ADVOCACY ORGANIZATIONS TO BECOME MUCH MORE SOPHISTICATED IN TERMS OF THE TYPES OF INFORMATION, TYPES OF SERVICES AND PROGRAMS WE HAVE TO RUN AND FUND IF WE WANT TO BE PART OF THIS AND WE WANT TO BE ABLE TO PROVIDE PATIENTS WITH GOOD INFORMATION SO THEY CAN BE -- SO WE HAVE DONE SEVERAL THINGS ALONG THE GAMUT SO I WON'T GO INTO THAT UNLESS THERE'S AN EXAMPLE. I KNOW ONE ISSUE WE'RE HAVING ONE THING WE'RE TRYING TO LOOK AT NOW IS UNDERSTANDING SPECIFICALLY FOR PANCREATIC CANCER WHERE IS MOLECULAR PROFILING DONE AS STANDARD OF CARE. IF YOU GO TO INSTITUTIONS, WEBSITES AROUND THE COUNTRY THEY SAY THEY'RE DOING PROFILING AND YOU CAN'T REALLY GET AT WHAT THAT MEANS WHICH DISEASES THEY DO IT FOR ROUTINELY, AND FOR US BECAUSE WE PROVIDE A SERVICE FOR THIS, WE'RE TRYING TO UNDERSTAND WHERE TO PUSH PATIENT BACKS TO HAVE IT DONE WITH PROVIDER VERSUS WHERE WE NEED TO STEP IN AND HELP THEM WAS THEY'RE NOT GOING TO GET IT OTHERWISE. AND WE'RE TRYING TO FIGURE HOW TO VALIDATE THAT. THAT TO ME IS AN ISSUE WE'RE STRUGGLING WITH. THE IDEA OF THESE CLINICAL TRIALS PANCREATIC CANCER IS BEING TREATED AS ONE DISEASE. BUT IT'S NOT. SO HELP REALLY BEING FORCED TO WORK WITH THE FIELD TO CHANGE THAT DIRECTION HAVING THE FUND LARGE EXPENSIVE INITIATIVES. JUST PLAYING A ROLE ADVOCACY TRADITIONALS HAVE NOT MAYED. >> JULIE, WHAT YOU SAID MAKES ME THINK OF ONE OF THE ISSUES WE DEAL WITH IS LACK OF STANDARD FOR WHAT MOLECULAR TESTS NEED TO BE DONE THAT YOU CAN TIE MEDICALLY NECESSARY TO FOR WHAT YOU CAN GET BOTH REIMBURSEMENT BUT ALSO THE NORMATIVE QUESTION OF WHAT SHOULD BE DONE BY WHOM AND IN EXCHANGE FOR WHAT KIND OF MONEY TO GO FORWARD. SO I DON'T KNOW IF PANCREATIC OR BREAST CANCER OTHER AREAS WHETHER STANDARDS HAVE BEEN SET BY COLLEGE OF AMERICAN PA THOLING, BRAIN TUMORS NOT SET BUT ON THEIR WAY. >> THEY'RE NOT SET FOR PANCREATIC CANCER EITHER AND CERTAINLY A LOT OF RESEARCH DONE TO GET TO PLACE WE KNOW WHO TO TEST AND HOW IT WILL BE USEFUL. OUR STANGS HAS BEEN IF YOU DON'T START GATHERING THAT INFORMATION AND LEARNING, WE'RE NEVER GOING TO GET TO THAT POINT RATHER THAN STAYING ON SIDE OF WE WON'T KNOW WHAT TO DO FOR EVERY PATIENT SO WE FORCED IT BUT IT'S ALSO FORCING US TO PAY FOR EXPENSIVE PROGRAMS IN ORDER TO GATHER THAT INFORMATION. SO THAT WE CAN LEARN. >>TY AGREE ACCESS TO CLINICAL TRIALS IS A MAJOR ISSUE. I ALSO THINK EQUALLY AS IMPORTANT IS THE ISSUE OF FINDING A CLINICAL TRIAL. WE'RE AT A TIPPING POINT, I HAVE DONE WORK WITH CLINICALTRIALS.GOV TEAM, I HAVE AN IT BACKGROUND. AND SO I THINK THEY HAVE IF THEY WERE TO SHARE VISION WITH THIS GROUP, PEOPLE WOULD BE IMPRESSED WITH THE VISION. QUESTION IS HOW TO GET FROM HERE TO THE VISION. I CAN IT WILL YOU THERE'S SIGNIFICANT ISSUES IN TERMS OF THE WAY WE'RE PROVIDING DATA TO CLINICALTRIALS.GOV. IF WE DON'T IF I CAN THOSE PROBLEMS, I DON'T CARE HOW SOPHISTICATED THE USER INTERFACE IS, THE RELEVANCE OF THE TRIALS WE PRESENT NEVER WILL MATCH THE GOAL WE SHOLD HAVE COLLECTIVELY. WE CANNOT BECOME AMAZON EASY TO USE INTERFACE WITHOUT THE SUPPORTING DATA. >> WE BUILT A WRAPPER AROUND CLINICALTRIALS.GOV SEARCH FOR BRCA AND HEREDITARY CANCERS. AND ONE OF THE THINGS WE HAVE SOMEONE WITH BACKGROUND IN IT AND DATABASES AND SHE WAS LOOKING WE WERE TRYING TO HELP PEOPLE FIND TRIPLE NEGATIVE VERSUS HER-2 POSITIVE. THE WAY THAT DATA IS ENTERED IS SO DIFFERENT WE HAVE TO TAKE CRITERIA OUT OF OUR SEARCH BECAUSE THERE'S SO MANY WAYS PEOPLE INPUT HER 2 POSITIVE, HER 2 NEGATIVE, TRIPLE NEGATIVE, IF YOU'RE TRYING TO BUILD A WRAPPER TO HELP COMMUNITY TAP INTO THE GREAT INFORMATION ALREADY THERE, THERE'S NO UNIFORMITY ACROSS THE DIFFERENT CRITERIA THAT PEOPLE WOULD SEARCH. SO THERE'S AN OPPORTUNITY THERE. IS THAT -- >> EXACTLY WHAT I'M SAYING SO I KNOW MORE THAN I SHOULD ABOUT THIS. SO THE ISSUE BECOMES HOW DO WE TALK ABOUT WHO THIS TRIAL IS RELEVANT FOR, INCLUSIONS AND EXCLUSIONS. RIGHT NOW, I CAN'T GET -- PRECISION MEDICINE MAKES THIS PROBLEM EXNO ANYONIALLY WORSE. WE HAVE TO SOLVE THIS, I THINK ADVOCACY GROUPS ARE LOOKING FOR AND PUTTING WRAPPERS AROUND CT.GOV BUT THEY'RE HAVING -- THEY'RE FINDING OUT THEY HAVE TO GO IN THERE AND GET INTO THE GUTS OF THE DATA. BECAUSE -- AND WILL TRACK WHERE I'M EGOING. A LOT OF DATA IS ONE FEEL, FREE FORM TEXT, IT'S NOT PULL DOWN, I SELECT THIS THIS DATA POINT OR THAT DATA POINT. SO IT'S VERY STRUCTURED. IT'S VERY UNSTRUCTURED. SO YOU HAVE TO INTERPRET IT, WE CAN CREATE ARTIFICIAL INTELLIGENCE ON CASE-BY-CASE BASIS, YOU HAVE TO GO IN AND CREATE ARTIFICIAL INTELLIGENCE MIGHT BE USED FOR YOUR TRIAL, MIGHT BE DIFFERENCE FROM WHAT I USE FOR YOURS. SO WE CAN'T GET THERE THE C -- CT.GOV FOLKS HAVE THE VISION AND KNOW WHAT THEY NEED TO DO BUT UNLESS WE COLLECTIVELY HELP THEM, I DON'T THINK WE CAN -- >> I WOULD ADD IT PROBABLY GOES FURTHER OUT BECAUSE THE COMPLIANCE WITH THE RECOMMENDATION STRAIGHTS OF A TRIAL. IS FAIRLY HORRIFIC. BECAUSE ADVOCACY GROUPS CAN PLAY A ROLE IS PRESSURE TESTING HOW FAR REGULATORY -- THERE IS A REGULATORY REQUIREMENT BUT THERE'S NO ENFORCEMENT SO THE REGISTRATION OF THE TRIAL ISN'T TIED TO ANY THINGS, SPONSORS WORRY ABOUT COMPETITIVE INTELLIGENCE. WE'RE WORKING ON SOMETHING UNIQUE AND BIOMARKER SPACE, PRECISION MEDICINE, HOW MUCH DO I PUT OUT THERE. PHASE 1 ISN'T REQUIRED TO BE REGISTER BUD MOST DO. THERE'S A LOT OF THINGS BUT YOU MAYBE LOOKING FOR A TRIAL THAT EXISTS BUT ISN'T THERE, ISN'T ACCURATELY REPRESENTED SO IT GOES (INAUDIBLE). TO BE FAIR TO PATIENTS AND FAMILIES WHO GO TO THAT TOOL THIS IS MY (INAUDIBLE) PATIENTS RELY ON GET INFORMATION -- THEY CARE ABOUT CLINICAL TRIALS FROM THEIR CARE PHYSICIANS. SO ANOTHER PLACE -- THOSE PHYSICIANS MOB TRYING TO USE C.D..GOV. >> THAT'S PART OF THE CHALLENGE. REFERK CLINICIAN CANNOT FIND A RELEVANT TRIAL BECAUSE IF -- IT'S THE SAME UNSTRUCTURED DATA. I HAVE CLINICIANS THAT KNOW I'M DOING WORK WITH THEM. BLESS YOU, I CAN'T FIND TRIALS FOR MY PATIENTS. >> SOMEWHAT REFER, IF IT'S ANOTHER -- AND THIS IS THE CHALLENGE WE SAW, SO GOING BACK TO TRIPLE NEGATIVE BRCA. I DID A SERIES OF SLIDES AND KIND OF THIS EXERCISE. I LOOKED UP ALL THE BREAST CANCER CLINICAL TRIALS FOR METASTATIC BREAST CANCER IN THE COUNTRY AT THE TIME I WAS DOING THIS POWERPOINT. I SHOWED IT ON THE MAP AND LOOK AT TRIPLE NEGATIVE AND THE BRCA. AT THE TIME THERE WERE FIVE BRCA CLINICAL TRIALS, THEY WERE FOR PEOPLE WITH BRCA 1 OR 2 AND METASTATIC BREAST CANCER VERY SMALL SPECIFIC POPULATION. VERY RELEVANT TO PEOPLE IN THAT POPULATION WHO WILL BE MOTIVATED TO SEE STUDIES GET COMPLETED FOR NEW AGENTS FOR THAT COMMUNITY. IT WAS SPECIFIC THEN I LOOK AT TRIPLE NEGATIVE BECAUSE THERE'S OVERLAP AND THEN THE ERPR POSITIVE BECAUSE THERE'S OVERLAP WITH BRCA TWO. SOMETHING LIKE 300 CLINICAL TRIALS FOR TRIPLE NEGATIVE BREAST CANCER, OR FIVE CLINICAL TRIALS FOR BR CCA SO YOU CAN SEE THE CHALLENGE WHEN YOU HAVE THIS SMALL USED A PUZZLE, IF YOU ONLY HAVE A CERTAIN NUMBER OF PUZZLE PIECE WHOSE ARE BRCA TO COMPLETE THE PUZZLE, AND YOU HAVE MUCH MORE TRIPLE NEGATIVE PUZZLE PIECES BUT MORE LIMITED TO COMPLETE THE TRIPLE NEGATIVE SO IF YOU'RE COMING WITH THE IDEA OF EACH OF THESE ARE PUSSINGS AND WE NEED TO COMPLETE THEM ALL. PUZZLES AND WE NEED TO COMPLETE THEM ALL, IT MAKES SENSE KNOW TO PRIORITIZE IN SOME WAY AS A COMMUNITY, FIGURING HOW TO GET PUZZLES COMPLETED WITH A LIMITED PUZZLE PIECE. SO START WITH RARE ONES. I THINK YOU NEED TO INCENTIVIZE HEALTHCARE PROVIDERS POPULATION TO THE REFER PEOPLE TO ANOTHER INSTITUTION. BUT HAVE RECIPROCITY AND EVEN RECIPROCITY BETWEEN COMPETING BIOTECH COMPANIES. FOR EXAMPLE, GENENTECH IS SPONSORING A CLINICAL TRIAL PEOPLE WHO MAY NOT QUALIFY FOR THAT WORK COLLABORATIVELY WITH OTHER BIOTECH AND SAY PEOPLE WHO MAYBE CLOSE TO THE POPULATION WE'RE ENROLLING HERE, THEY DON'T QUALIFY FOR THIS STUDY, REFER THEM TO THIS STUDY. I JUST THINK WE CAN GET ALL THESE STUDIES DONE BUT WE HAVE TO DO IT IN A WAY WHERE HARDEST PEOPLE ARE PUT INTO OR AT LEAST PRIORITIZED AND NOTIFIED ABOUT THE HARDEST FILL CLINICAL TRIALS THEY QUALIFY. AND MOVE OUT FROM THERE. >> NOT TO -- PRESSURING THE CENTRAL PREMISE OF TOO MANY TRIALS TOO FEW PATIENT BUS IF WE SAW PUZZLES MAYBE THERE ARE PATIENTS AND IF WE SOLVE THE PUZZLE THERE COULD BE MORE FITS. (OFF MIC) >> GREG. >> >> I REMEMBER READING THIS EDITORIAL WHEN IT CAME OUT AND ONE OF THE THOUGHTS THAT IMDA INTO MY HEAD WAS DO WE HAVE TO VIEW PATIENTS FOR CLINICAL TRIALS -- TOO FEW PATIENTS FOR CLINICAL TRIALS? MY PERSPECTIVE IS ILLUSTRATED BY WHAT WE FACE IN PEDIATRIC ONCOLOGY. WE HAVE BEEN FACED WITH THIS PROBLEM TOO FEW PATIENTS TO DO CLINICAL TRIALS. SO THE WAY THAT HISTORICALLY THAT HAS BEEN COMBATED IS BY BEING COLLABORATIVE ACROSS THE COUNTRY AND WITH EUROPE AND ACROSS THE WORLD BUT ADDITIONALLY THIS IS KEY. CLINICAL TRIAL PARTICIPATION IN PEDIATRIC ONCOLOGY IS MUCH MORE THAN ADULTS SO IN MY MIND WHEN I THINK ABOUT IS THERE ENOUGH PATIENTS FOR THESE TRIALS WHEN IT COMES TO RARE ADULT CANCERS, MY QUESTION IS THAT TRUE? IF WE GET BETTER CLINICAL TRIAL PARTICIPATION IN SOME OF THESE ADULT DISEASES, WOULD THAT BE THE CASE. THAT'S A QUESTION I AGREE THE QUESTION NEEDS TO BE ANSWERED BUT GOING FORWARD THE ADULT COMMUNITY WILL FACE THE SAME PROBLEMS IF PEDIATRIC COMMUNITY SYSTEM -- THAT IS AS WE FURTHER REFINE THE DISEASE SUBGROUPS ALL THE ADULT DISEASES ARE GOING TO BECOME WE HAVE A DISEASE LIKE BLASTOMA, THERE'S MAYBE A HUNDRED CASES IN THE UNITED STTES IN A YEAR. YET WE HAVE BEEN ABLE TO PUSH BLASTOMA SURVIVAL RATE OVER 80%. 70 TO 80% FIVE YEAR SURVIVAL RACE, WE DO IT BY COLLABORATIVE INTERNATIONAL CLINICAL TRIALS. SO THAT'S I THINK THERE'S AN OPPORTUNITY FOR PERSPECTIVES WHEN THE PEDIATRIC FROM WORLD TO BE SHARED WITH ADULT WORLD VICE VERSA. THE DRUG DEVELOPMENT COULD HELP PEDIATRIC WORLD BECAUSE WE DON'T FACE THE PROBLEM OF TOO MANY DRUGS TO TEST IN PATIENTS. WE HAVE TOO FEW PATIENT AND THERE'S NO DRUGS TO TEST. THERE'S EXPERTISE ON BPO SIDES, IF YOU PUT TOGETHER THERE'S AN OPPORTUNITY TO HELP DISEASE GOING FORWARD THESE ARE SOLVABLE PROBLEMS, JUST LOOK AT A LITTLE BIT DIFFERENT PERSPECTIVE THAN DONE HISTORICALLY. ARE WE GETTING OURSELVES THE PATIENT COMMUNITY READY ENOUGH TO BE THE CANCER PATIENT FOR THE MOLECULAR WORLD? WHO IS DOING THE MOLECULAR TEST SOMETHING IF WE DON'T KNOW IN ONE CANCER, WE DON'T KNOW IN ANOTHER CANCER. IS THAT AN ADVOCACY ISSUE WHERE IT'S FILE FOR SOME CHANGE FOR THE ADVOCACY COMMUNITY TO COME TOGETHER AND SAY LET'S FIGURE THIS OUT, LET'S GET OUTSIDERSES READY, LET'S GET THE RIGHT -- WE NEED PROVIDERS, INSURANCE COVERAGE, WE NEED TO GET OURSELVES THIS SERVICE SO WE CAN BE AS READY AS WE WAN TO BE. SOME SAY NOT FOR ME. BECAUSE I GET CANCER, I DON'T WANT TO KNOW ANY MORE, IT'S PATIENT CHOICE, FAMILY CHOICE. ARE WITH DOING ENOUGH AS ADVOCACY COMMUNITY TO GET YOURSELF READY FOR PRECISION NOTICE. >> IN TERMS OF ACCESS TO PRECISION MEDICINE TRIAL. I THINK WHAT WE HAVE SEEN IN THE PEDIATRIC SPACE AND SEEN IN ADULT SPACE, YOU'RE ANOTHER A PARTICULAR INSTITUTION THAT MAY HAVE A STRONG PROGRAM OF THEIR OWN. OUTSIDE THE INSTITUTION WHEREAS EVERYBODY SHOULD HAVE THE SAME PLAN AND ACCESS TO INFORMATION ABOUT WHAT IS ALL AVAILABLE IN PRECISION MEDICINE IN THEIR SPACE ARE THEIR THAN THIS IS WHAT I RECOMMEND THERE'S A LOT OF COMPETING AMONG INSTITUTIONS AND YOU HAVE THESE MATCH AND OTHER COLLABORATIVE EFFORTS THAT AREN'T -- THAT ARE COMPETITION. IT'S CREATING MORE COMPETITION AMONG OTHERS. IT'S OF CONCERN THAT IF YOU'RE NOT BEING TREATED IN YOUR MIDWEST, YOU'RE SCREWED BECAUSE YOU'RE NOT ABLE TO FIND WHAT YOU NEED. TWO ISSUE, ONE INADEQUATE CLINICAL TRIAL EDUCATION AND REFERRAL. THE OTHER IS INADEQUATE PROFILING SO THE PATIENT UNDERSTANDING THEIR OWN TUMOR SUFFICIENTLY TO MOVE TO THE RIGHT LANE RIGHT TRIAL FOR THEM. LET'S WORK THE MOLECULAR PROFILING. HOW DO WE MOVE FORWARD WITH THAT TO KNOW IF AGAIN NON-PROFITS ARE AROUND BECAUSE OF MARKET FAILURE AND GOVERNMENT FAILURE TO SOME EXTEN. HOW DO WE STEP UP AND START TO FRAME THAT ISSUE U, GET AROUND IT, MARY APP? -- MARY ANN? >> I WAS THINKING WHEN YOU FIRST BROUGHT IT UP, I TOTALLY AGREED WITH DANIELLE AS AN ADVOCACY GROUP I'M NOT -- I MEAN, OUR FIRST OBLIGATION SO TO EXPLAIN WHAT THAT IS. I DON'T KNOW THAT IF WE ASK PEOPLE ON THE STREET DO YOU KNOW WHAT PRECISION MEDICINE IS AND IT BENEFIT HOUSE? ANYONE HAVE ANY IDEA WHAT WE'RE TALKING ABOUT. MAYBE I'M WRONG BUT I HAVE TO GO BACK -- PRECISION MEDICINE COULD BE GENETICS. IT COULD BE BIOMARKER, IT COULD BE DIFFERENT THINGS. I THINK THERE'S A CHALLENGE TO THE ADVOCACY COMMUNITY TO EDUCATE WHAT PRECISION MEDICINE MEANS. CREATING A VISION FOR 2025. I THINK WOULD BE GOOD. IT WOULD BE -- SIMPLE ISSUE, SOUNDS SIMPLE. IF YOU DONATE YOUR GENOME AS PART OF RESEARCH TRIAL MOST COMPANIES DO NOW, DO YOU OWN YOUR DATA? SHOULD YOU NOT GET YOUR DATA, SHOULD YOU NOT HAVE -- I HAVE DONE 23 AND ME AND I GOT IT AND LOOKED AT IT AND MY GENOME IS FAIRLY BORING. OTHER THAN BROWN HAIR BLUE EYES, # 9% EASTERN EUROPEAN. BUT PATIENTS WANT DATA, WHERE DOES THAT FIT IN? THE DATA TO SAY HEY, I -- YEAH YOU LOOK AT MY GENOME FOR THIS, AND THIS IS WHAT WE KNOW ARE CERTIFIED GENETIC MARKERS TODAY. BUT IN TEN YEARS WHEN THEY DEVELOP ANOTHER TEST THAT SHOWS THREE MARKERS AVAILABLE FOR CERTAIN CANCERS HOW DO I TAKE MY DATA TO GO BACK AND HAVE SOMEONE -- BECAUSE THAT CONTINUING ONGOING NEED GENES AREN'T -- THE GENOME IS NOT GOING TO CHANGE. IT'S GOING TO (INAUDIBLE) AND SPONSORS ARE TALKING ABOUT, GOING TO -- (INDISCERNIBLE) WHERE A PATIENT LIVES. HOW CAN WE HAVE REMOTE ELECTRONIC INFORMED CONSENT? WE CAN SHIP DRUG, WE CAN SHIP SAMPLES. (INDISCERNIBLE) SO TAKING TIME TO GETTING (INAUDIBLE) (INDISCERNIBLE) THAT'S GOING TO HELP THEM -- MANAGE PATIENTS. SO I THINK (INAUDIBLE) (INDISCERNIBLE) (INDISCERNIBLE) (INDISCERNIBLE) >> COULD THOSE ON THE PHONE PLEASE MUTE? WE'RE HAVING A HARD TIME HEARING. >> MARY ANN, THAT WAS A LOT OF DIFFERENT IDEAS. AND THEY'RE INTERESTING SO I HAD COMMENTS ON A LOT OF THEM. ALSO AROUND THIS TUMOR PROFILING EDUCATING PATIENTS, PART OF IT IS THOUGH THAT THIS ENTERED THE COMMERCIAL SPACE. AND SO YOU MENTION 23 AND ME. SO WE HAVE HAD PEOPLE COME TO FORCE AND THEY HAVE DONE 23 AND ME AND THEY DON'T GET RESULTS ON BRCA SO THEY RUN IT THROUGH PROMEATIUS AND THEY GET THESE RESULTS THEY DON'T UNDERSTAND. SO ONE IS TRYING TO KEEP UP WITH ALL THESE COMMERCIAL TESTS THAT ARE MARKETING THESE TESTS FOR TUMOR PROFILING BUT THEY HAVEN'T NECESSARILY BEEN VALIDATED YET. INSURANCE ISN'T NECESSARILY COVERING IT YET, CLINICS DON'T REALLY KNOW WHAT TO DO WITH THE INFORMATION YET. SO WITHIN A CLINICAL TRIAL IT MAY MAKE SENSE AND WE CAN EDUCATE PEOPLE AROUND IT BUT AT THE SAME TIME IF THERE'S COMPANIES COMMERCIAL ENTITIES MASHING IN IT AND THEY'RE ALREADY DEVELOPING PATIENT FACING INFORMATION, IT MAKES IT REALLY HARD FOR US TO STEP INTO THAT SPACE AND SAY WHOA, WAIT. I AGREE PEOPLE SHOULD HAVE ACCESS TO THE INFORMATION ABOUT TUMOR AND ACCESS TO WHAT IT MEANS AND ACCESS TO UPDATES ON IT. BUT I'M NOT INSURE HOW YOU DO THAT, OR HOW YOU ONLY KATE PEOPLE ABOUT THIS WORLD OF TUMOR PROFILING IN A CLINICAL TRIAL, TUMOR PROFILING THROW A COMPANY. IT'S HARDER THAN JUST HAVING DEVELOP EDUCATIONAL MATERIAL. BUT I'M NOT SURE WHAT THE ANSWER IS. WE NEED TO GO IN THAT DIRECTION AND INFORM CONSUMERS. PEOPLE WANT IT. I'M WORRIED ABOUT WHAT WILL BE DONE WITH IT AND WHO IS PROFITING OFF OF IT AND HOW IT'S BEING USED AND IS IT REALLY BEING TIED TO PATIENT OUTCOMES. >> I WAS GOING TO SAY IN REGARDS TO THE PROFILE, I THINK WE'RE AT THE POINT NOW WHERE THERE IS INTEREST FROM PATIENTS AND GROUPS TO GET PROFILING BUT WE'RE NOT AT THE PLACE SCIENTIFICALLY WHERE WE CAN DEFINITIVELY SAY IT NEEDS TO BE DONE. SO I WHAT ENDS UP HAPPENING IS THERE'S RESEARCH GOING ON TRYING TO UNDERSTAND -- SO I DON'T KNOW WE'RE AT THE POINT TO MANDATE BUT YOU'RE NOT GOING TO QUESTION WHETHER OR NOT A PATIENT GOING IN IS GOING TO GET A HISTOLOGIC ANALYSIS OF TUMOR BUT PROBABLY IN TEN, 15 YEARS, THE PROFILING IS GOING TO BE CONSIDERED IN THE SAME VEIN AS HISTOLOGY IS NOW, PATHOLOGY IS NOW. HOW DO WE SUPPORT RESEARCH -- PARTICIPATION BY PATIENTS THAT WILL SUPPORT RESEARCH THAT NEEDS TO BE DONE TO ANSWER THAT QUESTION AND GET TO THE POINT WHERE PROFILE IS ACTUALLY (INAUDIBLE) FOR ALL PATIENTS. THE WAY IT IS NOW DEPENDING -- DANIELLE ALLUDED TO THIS, YOU CAN BE A PATIENT AT A HOSPITAL AND YOU GET YOUR TUMOR SEQUENCED GERM LIEN SEQUENCED, -- LINE SEQUENCED IF U YOU SHOW UP SIX HOURS A WAY YOU MIGHT NOT GET THAT DONE. AS THESE TYPES OF STUDIES BECOME COMMON PLACE THE ROLE OF THE ADVOCACY COMMUNITY IS TO MAKE SURE ALL PARENTS HAVING ASSESS TO THAT SAME BASELINE INFORMATION. IT WILL TAKE A WHILE TO GET TO THAT POINT. >> GREG TO PRESS A BIT, ARE YOU THINKING RIGHT NOW MOLECULAR PROFILING IS NOT ENOUGH OF A MEDICAL SERVICE YET FOR WHICH PATIENT ADVOCACY COMMUNITY NEEDS TO PRESS ON ACCESS ISSUES, IS IT TOO IMMATURE FOR US TO SAY WE NEED ROBUST ACCESS TO IT, ACCESS INSURANCE COVERAGE FOR IT OR DO WE NEED MORE TIME? >> I THINK WE NEED MORE TIME. I DON'T KNOW IF YOU HAVE THE EVIDENCE TO GO TO ARGUE THAT IT NEEDS TO BE COVERED BY INSURANCE. I THINK WE'RE -- PETTY NOW (INAUDIBLE) TO GET THERE WE HAVE TO HAVE WHAT'S NEEDED COMPLETED. SO THAT WE CAN ARGUE THAT. ANYTHING WE CAN DO TO GET MORE PATIENTS INVOLVED FOR RESEARCH ASPECT WILL APPLY WHEN WE GO TO TRY TO GET THEM MANDATED CARE. IT'S COMING FAST BUT I DON'T KNOW IF WE'RE THERE YET. >> SO I THINK AS ALWAYS TRUE, WE ADVOCACY SIDE NEED TO BE PUSHING THE AGENDA THAT PATIENTS SHOULD BE SEEKING CLINICAL TRIALS. I KNOW WHAT (INAUDIBLE) THE UNIVERSAL GOAL SHOULD BE EVERY PATIENT SHOULD CONSIDER A CLINICAL TRIAL. WHETHER THEY PARTICIPATE OR NOT. I DON'T THINK THE ADVOCACY COMMUNITY IS BRINGING THAT BELL LOUDLY ENOUGH, UNIVERSALRY, I KNOW THIS POCKETS. I GET IT. PARTICULARLY IN THE AREA AS PRECISION MEDICINE PIX UP SPEED, THE OTHER ISSUE THAT WE NEED TO BE PUSHING IS SECOND OPINIONS. BECAUSE WHERE IT USED TO BE THE CASE, WE'RE REACHING A POINT WHERE IF YOU DON'T GET THE SECOND OPINION YOU WON'T FIND OUT ABOUT THE CLINICAL TRIAL THAT YOU DIDN'T KNOW ABOUT IN PRECISION MEDICINE THERE ARE POCKETS. SO THOSE ARE TWO KEY MESSAGING POINTS THE ADVOCACY COMMUNITY WILL PUSH HARDER. THE SECOND OPINION ONE IS A LITTLE TRICKY FOR THE ADVOCACY GROUPS. THEY DON'T WANT TO SECOND GUESS PHYSICIANS. ON THE OTHER HAND WE HAVE TO ENCOURAGE PEOPLE TO DO THAT. >> -- AMONG RESEARCHERS DISCUSSING PRECISION MEDICINE RECENTLY IN THE BAY AREA, IT WAS A NATIONAL CONVENE BUT BIG CONVERSATION WAS AROUND PRECISION MEDICINE ALSO MEANS MAKING BETTER USE OF BIG DATA. AND GETTING BETTER AROUND SHARING DATA THAT EXISTS OR SHARING THE DATA THAT WERE INCREASINGLY COLLECTING. AND DOING BETTER ANALYSIS OF THAT DATA. FOR US TO REMEMBER, I APPRECIATE THE POINT Y'ALL BROUGHT UP EARLIER ABOUT MAKING SURE THAT FOLKS ARE SHARING DATA AND DOING BETTER ANALYSIS. SO WE'RE NOT JUST CONCENTRATEING AT THE INDIVIDUAL PATIENT LEVEL AND WHAT THE BENEFITS OF PRESIS ARE FOR THE INDIVIDUAL BUT ALSO LOOKING AT LARGE POPULATIONS, THAT'S ONE POINT I WANT TO SHARE. ANOTHER IS THAT AS WITH MANY CUTTING EDGE TECHNOLOGICAL ADVANCES, THE SAME COMMUNITIES UNDER-REPRESENTED IN CLINICAL TRIALS GET LEFT OUT. WHETHER'S FOLKS IN RURAL GEOGRAPHY, FOLKS WHO AREN'T PROFICIENT IN ENGLISH, POPULATIONS HISTORICALLY BEEN EITHER HARMED OR ABUSED BY THE SCIENTIFIC ENTERPRISE, WE RUN THE RISK OF EXACERBATING THAT LACK OF REPRESENTATION IN CLINICAL TRIALS. WE FOUND FOR EXAMPLE, THAT WHILE ALL ARE EXCITED ABOUT POTENTIAL REPRESENTED THROUGH UNDERSTANDING MORE DEEPLY GENETIC MAKE UP OF EACH INDIVIDUAL PATIENT, WE LEARN THERE'S NOT A LOT OF FOLKS -- NOT A LOT OF GENETICS COUNSELORS WHO SPEAK SPANISH. FOR EXAMPLE, ACROSS THE AMERICAS SO THIS IS NOT JUST A PROBLEM HERE IN THE U.S. BUT ACROSS THE AMERICAS, THERE AREN'T FOLKS WITH THAT LEVEL OF TRAINING. WHO SPEAK LANGUAGES OTHER THAN ENGLISH SO IT'S CHALLENGE REPRESENTED IN OTHER LANGUAGES. AS WE PURSUE OPPORTUNITIES REPRESENTED PRECISION MEDICINE, I THINK WE JUST NEED TO STAY COGNIZANT OF THE PERSISTENT CHALLENGES TO ENGAGING THOSE SAME POPULATIONS THAT ARE ALWAYS UNDER-REPRESENTED CLINICAL TRIALS. >> SO JUST SORT OF TAKE STOCK WHERE WE ARE, BECAUSE WE'RE PROBABLY ALL HUNGRY AND TRYING -- IS WE HAVE WORKED TWO DIFFERENT LEANS OF THE LAST FEW MINUTES, ONE IS THE MOLECULAR PROFILING AREA AS AN AREA FOR PATIENT ADVOCACY AND WE HAVE IDENTIFIED SEVEN ISSUES, ONE THE DEFINITIONAL CHALLENGE OF IT, WHICH MARY ANN YOU BROUGHT THAT UP AT THE BEING HOW TO DEFINE GETTING INTO, HOW DO WE KEEP UP WITH THE UNVALIDATED TEST, WHO IS DOING IT OUT THERE. ARE THEY QUALIFIED. WHAT ABOUT INSURANCE REIMBURSEMENT FOR IT? ARE CLINICS -- ARE THEY CAPABLE OF USING THE INFORMATION? WHAT IS THE STATUS OF THAT? GREG BROUGHT THAT UP WHAT IS NEEDED IN TERMS OF MOLECULAR PROFILING AND WHAT NEEDS TO BE VALIDATED IN ORDER TO MAKE IT -- TO KNOW IT'S MEDICALLY NECESSARY AND RIGHT FOR PATIENTS. THEN A 7TH ISSUE IS WE DIDN'T BRING THIS UP, IT'S -- IT'S BEEN AROUND FOR COUPLE OF YEARS, THE SAFETY OF THE TEST ITSELF, THERE'S QUITE A FDA DEBATE GOING ON ABOUT THE SAFETY OF LABORATORY DIAGNOSTIC TESTS. IN OUR CLINICAL TRIALS ONLYCATION, WE DISCUSSED THE POINT THAT RICK AND OTHERS BROUGHT UP, EVERY PATIENT SHOULD KNOW ABOUT CLINICAL TRIALS. EVEN IF THEY DON'T GO INTO ONE, KNOWING ABOUT IT. ROBERTO BROUGHT UP PART IS MAKING SURE IT'S NOT JUST GENERAL EDUCATION, IT'S SPECIFICALLY ADDRESSING THOSE COMMUNITIES WHERE THERE LEAST LIKELY TO BE EDUCATED OR ENGAGED IN CLINICAL TRIALS AND BROUGHT UP EARLIER THIS IS TYPICALLY CLINICAL TRIALS EDUCATION NOT TYPICALLY REIMBURSABLE EVENT, THERE'S NOT REIMBURSEMENT FOR CLINICAL TRIALS EDUCATION, CERTAINLY NOT REIMBURSEMENT FOR REFERRAL. THOSE ISSUES WERE NOT POLICY ISSUES FOR THE MOON SHOT EXERCISE OF LAST YEAR IN A POLICY DOCUMENT BUT WERE NOT TAKEN UP. THESE ARE CRITICAL ISSUES. AS SOMEONE THAT PARTICIPATES IN COALITIONS, I FIND THERE'S NOT LOT OF COALITION ACTIVITY AROUND THE ISSUES WE JUST DISCUSSED IN SORT OF THE CLASSIC WASHINGTON BASED PUBLIC POLICY ADVOCACY WORK WE DO. WE'RE VERY MUCH FOCUSED ON APPROPRIATIONS, FOCUSED ON HEALTHCARE REFORM. THERE IS A CROP OF ISSUES COMING UP IN ADVOCATES THAT WE HAVEN'T ADDRESSED YET AS COALITIONS PEDIATRIC LEVEL OR ADULT LEVEL. THIS IS THE KIND OF GROUP THAT CAN BRING THESE ISSUES TO LIGHT AND TALK ABOUT PIECES OF, PARTS AND WHOLES OF WHAT WE CAN DO TOGETHER. SO IF ANYBODY HAS SUGGESTIONS ON THAT, THIS WOULD BE A GOOD TIME TO TALK ABOUT WHAT ARE THESE TOPICS SHOULD WE THEN TAKE BACK TO OUR RESPECTIVE COALITION, SHOULD WE HAVE ANOTHER MEETING ABOUT THIS. HOW DO WE START TO TAKE ACTION ON SOME OF THESE ISSUES. FOOTNOTE POINT, ONE OF THE ISSUES THAT STRIKES ME, SOMETIMES THE ISSUES ARE NOT SQUARELY IN ONE FEDERAL AGENCIES JURISDICTIONS. THAT'S ALWAYS SOMETIMES A PROBLEM. IT'S NOT THE NCI JOB TO MAKE SURE THAT MOLECULAR PROFILING IS REIMBURSED. IT'S NOT THE FDA'S JOB EITHER. LOOK AT THE CDC CANCER CONTROL PROGRAM, THEY HAVE BEEN FOCUSED ON B SAPP AND TOBACCO CONTROL FOR DECADES. THINK OF PRECISION MEDICINE AS CANCER CONTROL ACTIVITY, IT'S NOT -- IT'S NOT BEING DISCUSSED AT THE CDC TERMS OF CLINICAL TRIALS EDUCATION. BUT I THINK YOU CAN MAKE A ARGUMENT THAT FUNDING OF STATE HEALTH DEPARTMENTS AND NON-PROFITS TO DO ONLY CASE AROUND CLINICAL TRIALS, RICK, COULD BE WORTH DOING. SOME OF THESE ISSUES DON'T FAIRLY FALL IN A NICHE FOR ONE AGENCY WHICH IS SOMETIMES A BARRIER TO MOVING POLICY ISSUES FORWARD. >> JUST OCCURRED TO ME, WHAT IF YOU COULD CONVENE ALL THE NIH INSTITUTES AROUND THIS ONE TOPIC WITH ADVOCATES AND PATIENTS JUST AROUND CLINICAL TRIALS ISSUE. BRING CDC AND NCI. CAN YOU BRING SILOED ORGANIZATIONS TOGETHER? ONE MEETING, WOULD THERE BE VALUE IN IT? JUST A COMMENT I GUESS. (OFF MIC) I THINK THAT DAVID'S QUESTION IS -- SO YEAH, THE ANSWER IS YES T. (INAUDIBLE) DEPENDING ON WORK WE DID WHAT ROLE ADVOCATES COMMUNITY PLAY WITH EACH OTHER AND ADS A FACILITATOR FOR THOSE DISCUSSIONS, YOU GUYS (INAUDIBLE) >> I THOUGHT FOR A LONG TIME THERE'S TREMENDOUS OPPORTUNITY FOR A LARGE SCALE EDUCATIONAL CAMPAIGN ABOUT CLINICAL TRIALS, THERE'S SUCH A LACK OF AWARENESS ABOUT IT. THAT HAS NOT -- THERE'S NO ONE DOING THAT. THERE'S NO ONE. THERE'S A HUGE GAP. I REMEMBER WHEN I FIRST GOT INVOLVED IN THIS INDUSTRY BACK IN 2000, THERE WAS ACTUALLY EFFORTS AROUND EDUCATING THE PUBLIC ABOUT CLINICAL CLINICAL TRIALS, IT SORT OF ALL DIED IN THE EARLY 2000s. SO I THINK THERE'S TREMENDOUS OPPORTUNITY AND ANECDOTALLY LOOKING PUBLISHED WORK THAT'S DONE. THE ENROLLMENT RATE FOR PANCREATIC CLINICAL TRIALS ACROSS THE TRIAL IS 4%. PRETTY IN LINE WITH ADULT CANCERS. FOR THOSE PATIENT WHOSE CALL OUR CALL CENTER AND GET CLINICAL TRIAL INFORMATION AND WE FOLLOW-UP SUIT ENROLLED IN THE TRIAL THE ENROLLMENT RATE IS 12%, FOR THE PATIENTS THAT KNOW THE TUMOR SERVICE WITH THE MOLECULAR PROFILING DONE AND BASED ON THE REPORT THE -- SO WE JUST SHOWS THAT TREMENDOUS OPPORTUNITY IF YOU'RE PROVIDING INFORMATION AND RESOURCES AND NARROWING, IT'S NOT THAT PATIENTS DON'T WANT TO ENROLL THEY JUST DON'T HAVE INFORMATION AND AS WE HAVE BEEN TALKING ABOUT LANDSCAPE, SO LARGE, SO MANY TRIALS, HOW DO I PICK THE ONE THAT IS BEST FOR ME. I WOULD LOVE TO SEE THERE WOULD BE A LARGE EDUCATIONAL AWARENESS CAMPAIGN AROUND CLINICAL TRIAL. HAPPY TO HELP. >> DAVID TO YOUR POINT ABOUT BRINGING COALITIONS, COALITIONS SHOULD CONVENE FIRST AND HAVE A CONVERSATION ABOUT WHERE YOU FEEL APPROPRIATE THAT WE CAN COME TOGETHER AND TALK ABOUT THOSE ISSUES AND HOW WE THINK WE CAN ENGAGE TOGETHER BETTER ON IT. THEN COME BACK TO GROUPS OR IN THE INTERIM O ARCR CAN WORK WITH US WHAT THEY ARE HEARING FROM INDIVIDUAL COALITIONS ON THE NEEDS AS WE MOVE FORWARD, KIND OF LARGER AGENDA. >> QUICK COMMENT. THE IDEA POPPED INTO MY HEAD. I GUESS HOW IS -- HOW ARE CLINICAL -- HOW IS PRECISION MEDICINE TRIAL LIKE THE MATCH TRIAL, THE ADULT MATCH TRIAL? HOW WAS THAT DIFFERENT THAN THE OTHER CLINICAL TRIALS? IN THIS REGARD. THAT WAS THE FASTEST ACCRUING CLINICAL TRIAL SO WHAT IS DIFFERENT ABOUT THAT ONE THERE'S SO MUCH PARTICIPATION? SO CLEARLY THERE'S PATIENT AND PROVIDERS THAT KNOW ABOUT IT IN SOME WAY. IF WE CAN FIGURE OUT WHAT IT IS ABOUT THAT EFFORT, THAT LED IT TO BE SO SUCCESSFUL, MAYBE SOME OF THE PRINCIPLES FROM -- THAT YOU UNCOVERED COULD BE APPLIED TO SOME OF THE DRUG TRIALS AND OTHER THINGS GOING ON. >> GOOD POINT. I DON'T HAVE THE ANSWER TO THAT ONE. >> I DON'T HAVE THE ANSWER SO I DON'T WANT TO GO THERE, I HAVE SOME IDEAS BECAUSE THERE'S SO MANY SITES AND A LOT OF OUR COMMUNITY BASED SITES PROGRAM SAW PATIENTS AND -- THOSE ARE HIGHEST ACCRUING SITES, I ALSO COUNT HELP IT WAS MULTIPLE MUTATION, MULTIPLE ARMS, ALL TUMOR TYPES. IT WAS BROAD. SO THERE'S A VARIETY OF DIFFERENT FACETS. THAT ALLOW THAT TO (INAUDIBLE). >> THAT'S -- THAT WOULD BE PART OF THE ANSWER THAT I WOULD GIVE, IT'S NOT THE WHOLE ANSWER BUT THE FACT THAT YOU HAVE A BASKET OF POSSIBILITY, THIS BETS BACK TO CLINICAL TRIAL AWARENESS IF I TRY TO BUILD AWARENESS AROUND A SPECIFIC TRIAL MATCH NOTWITHSTANDING I PROBABLY WILL FAIL, PROBABLY NOT A GOOD RETURN ON INVESTMENT. SO I THINK THAT THE MATCH TRIAL IS A GOOD DEMONSTRATION OF THE POWER OF THE MASSES. AND THE MATCH HAD A WIDE SWATH THAT IT TARGETED, THAT IT WAS SUCCESSFUL BECAUSE OF THAT, THERE WAS A LOT OF WORK DONE THAT WOULDN'T HAVE BEEN DONE HAD IT BEEN A SICKLE TRIAL WITH TWO ARMS. >> TO YOUR POINT EDUCATION WOULD BE AROUND THAT BASKET OF HERE ARE THE BREAST CANCER TRIALS, THIS IS WHAT BREAST CANCER LOOKS LEAK, HERE ARE CLINICAL TRIALS IN BREAST CANCER AND HERE ARE THE MORE SPECIFIC ONES. KIND OF GETTING TO THAT EDUCATION. SMALL BASKET AND LARGER BASKET OR SMALL POT AND LARGER BASKET, AND IF YOU DON'T QUALIFY FOR THIS ONE PERHAPS YOU QUALIFY FOR THIS ONE. MAYBE WE CAN BUILD A -- I DON'T KNOW WHAT THE WORD WOULD BE BUT STEP WISE GOING FROM THIS MOMENT TO THE LARGER JUST IN GENERAL AROUND CLINICAL TRIALS, SAME WITH OREGON TYPES OF CANCER, I KNOW BREAST, OVARIAN. THERE'S A LOT OF DIFFERENT SUBTYPES AND THERE ARE MORE SPECIFIC CLINICAL TRIALS AND THERE ARE LESS. KIND OF TEACHING PEOPLE TO LOOK AT THE MORE SPECIFIC AND SLIGHTLY LETS SPECIFIC AND THE REALLY NON-SPECIFIC ALL COMERS AND TRAINING PEOPLE THAT CLINICAL TRIALS ARE MORE NUANCED. >> ONE THOUGHT I HAD, I GUESS IT WAS ABOUT NOW YOU A YEAR AGO DANIELLE MAYBE MEMORY SERVES, THE -- A BIG PAPER WAS COMPLETED LOOKING AT THE LANDSCAPE OF CHILDHOOD CANCER RESEARCH. IT COVERED THINGS SO THESE TOPICS MOLECULAR PROFILE, CLINICAL TRIALS EDUCATION, MADE ME THINK OF IS THAT SOMETHING THIS GROUP OR THIS GROUP AUGMENTEDDED BY A FEW PEOPLE WE COULD IMAGINE A LANDSCAPE ANALYSIS THAT COULD BE WRITTEN THAT WOULD ANSWER CRITICAL QUESTIONS AROUND CLINICAL TRIALS EDUCATION OR WHAT DOES THE LANDSCAPE LOOK LIKE FROM MOLECULAR PROFILING. WHERE ARE OTHER STANDARDS THAT ATTACH TO WHERE THEY'RE NOT. WHAT'S VALIDATED. WHAT'S NOT. IDENTIFY -- ASK THE RIGHT QUESTIONS, GET SOME QUESTIONS ANSWERED, MAYBE THAT'S SOMETHING THE NCI COULD SPECK THE RIGHT STAFF TO LITERALLY DIVE INTO A LANDSCAPE ANALYSIS WITH THE ASSUMPTION HERE THAT DOING THAT ANALYSIS WOULD THEN ULTIMATELY FURTHER CANCER RESEARCH BECAUSE IT WOULD HELP RESEARCH AND WITH CARE. BUT IT WOULD PROVIDE SOME ANSWERS THAT WOULD HELP US ACROSS THE BOARD TO THE GAPS IN THE FIELD. IN ANY OF OUR NON-PROFITS'S HARD TO GET LANDSCAPE ANALYSES DONE BECAUSE THERE OFTEN ISN'T ONE STAFF VERSUS WHO CAN JUST DO IT. >> I WOULD SAY IT DEFINITELY REQUIRES -- WE DID IT IN SEVEN MONTHS, EIGHT MONTHS, IT REQUIRES A REAL COMMITMENT OF A TEAM OF COLLABORATIVE COALITION TO WORK TOGETHER. WE DID WEEKLY CALLS FOR EIGHT MONTHS TO GET THAT WRITTEN. >> I KNOW NCI WAS INVOLVED (INAUDIBLE) SCIENCE WEIGHING INTO COMPONENTS BUT VERY MUCH KEPT PRESSURE ON. >> SOMETIMES ADVOCACY START WITH KEY PIECE OF PUBLIC INTEREST RESEARCH BEING DONE. WHAT'S THE LANDSCAPE, WHAT'S THE TRENDS, WHAT'S THE TRAJECTORY OF THIS ISSUE, HOW DO WE GET A FOUNDATION. SAY WOW THERE'S A MASSIVE GAP IN THIS OR THAT AREA. THERE'S NO ONE ORGANIZATION THAT'S -- EVERYONE IS SAYING THEY WANT CLINICAL TRIALS BUT NO ONE ORGANIZATION IS FULLY COMMITTED TO IT. IN THE GLOBAL WAY. THINKING MAYBE CANCER SUPPORT COMMUNITIES IS DOING A LOT SO THAT'S KIND OF ONE EXAMPLE OF DOING A LOT. IS THAT SOMETHING THE NCI INTERESTED IN, THAT KIND OF LOOKING AT A LANDSCAPE OF THE FIELD. >> THIS COULD BE SOMETHING WE LOOK AT PUBLIC OR PRIVATE PARTNERSHIP BECAUSE IT DOES REQUIRE FUNDING IN ORDER TO MAKE THAT HAPPEN, WE DID HIRE AN EXTERNAL FIRM TO DO ANALYSIS AND OVERVIEW, IT WASN'T A CHEAP UNDERTAKING, BUT IT WAS PERFECTLY REASONABLE BUT IT'S SOMETHING THAT WHERE PEOPLE CAN PUT SKIN IN THE GAME IN PARTNERSHIP WITH NCI IN ORDER TO HELP GET IT DONE. (OFF MIC) ISSUES ARE IMPORTANT HOW TO WORK TOGETHER AND TAKE IT FROM THERE. >> WHAT ISSUES DOES THE NCTN, AT ISSUE. >> THE SEVEN TO EIGHT MONTHS, THE CHALLENGES WERE -- 200,000 FEET. WHAT'S THE -- WHAT WAS THE BIG CHALLENGE, BIGGEST CHALLENGES THAT REQUIRE ALL THIS EFFORT TO BE INVOLVED? >> I WOULDN'T SAY IT WAS CHALLENGES, IT WAS A BIG BULK OF WORK BECAUSE IF YOU SEE THE SCOPE OF THE PROBLEM THAT WE WERE EXAMINING PEDIATRIC CANCER IS A BIG BUCKET TO LOOK AT SO TRYING TO LOOK DOWN, WE SPECIFICALLY FOCUS ON RESEARCH DRUG DEVELOPMENT SO BEING FOCUSED AND DEFINED AND MAKING SURE WHICH STAYED WITHIN THAT LANE. SOME OF THE BASELINE INFORMATION THAT WE HAD TO GATHER WAS FROM MULTIPLE SOURCES AND MAKING SURE WE WERE BETTING AS GROUP. THE COMMITMENT TO THE COLLABORATIVE PROCESS, YES IT'S EASY FOR ONE ORGANIZATION TO GO OUT AND WRITE SOMETHING. IT'S SOMETHING VERY DIFFERENT WHEN YOU HAVE EIGHT OR NINE PEOPLE SITTING AROUND THE TABLE TRYING TO DO THAT, WRITING BY COMMITTEE, WE WERE ALL VERY INVOLVED IN THE PROCESS, THERE WAS A STEERING COMMITTEE AND EXTERNAL REVIEWERS OF CHAPTERS THEY HAD BUY FROM THE COMMUNITY SO THERE'S A LOT OF PROCESS TO MAKE SURE IT WAS VETTED APPROPRIATELY ACROSS THE CONTINUUM. IT IS PROCESS ISSUES, WE GOT THE BUY IN FROM THE COMMUNITY. BEFORE THINGS WERE ALSO SOME OF THIS REVIEW PROCESS OF E TERM CONSULTANT WORK AND WE DID ANALYSIS ON CLINICALTRIALS.GOV. IT WAS EXPENSIVE, THEY DID INTERVIEWS ACROSS THE COMMUNITY, WE HAVE CONSULTING FIRM NEUTRAL -- QUESTIONS ACROSS THE COMMUNE THE ON SOME OF THE CHALLENGES. AND OPPORTUNITIES THAT WERE THERE. SO REALLY IT WAS MORE PROCESS ISSUE. JUST TRYING TO GET IT DONE AND GET IT DONE WELL WITH BUY IN FROM THE COMMUNITY, FOR MULTIPLE SOURCES. THERE WAS TEN OF US ON THE COMMITTEE. I WOULD SAY FIVE WERE ON THE REGULAR CALLS BUT IT WAS REALLY GOOD GROUP OF COMMITTED PEOPLE WHO WERE ABLE TO DRIVE IT BUT IT REQUIRED EVERYBODY IN THE COMMUNITY, THE BUY IN TO FEEDING THE INFORMATION TO EVERYBODY. SO THAT WE CAN GET IT DONE. AS LONG AS YOU HAVE THAT DRIVING GROUP AND ONE THAT IS WILLING TO MAKE SURE THAT THERE'S BUY IN FROM EVERYBODY ELSE AND PEOPLE HAVE THE OPPORTUNITY TO COMMENT OR REVIEW PIECES, REALLY HELPS THE VALIDITY OF THE REPORT. >> I WAS GOING TO COMMENT, I THINK IT'S REALLY A GREAT IDEA. I THINK BALANCING THAT WITH WHAT WE KNOW WILL POTENTIALLY HAVE REGULATORY LANDSCAPE. PROFILING OF UNDERSTANDING EFFICACY OF THE DRUG. PREDICTING EFFICACY OF THE DRUG, IT WILL NOT GO INTO LARGER PHASE 3 TRIALS. CANCER IS ONE OF THOSE AREAS WHERE WE NEED MORE ASSURANCE PEOPLE GO INTO POPULATIONS, I THAT'S WHERE ADVOCACY HAS TO BE (INAUDIBLE) INFORM THE PUBLIC. TWO THINGS HAPPENING TOGETHER. RIGHT? SO IF WE CAN GAIN KNOWLEDGE AND INFORMATION POTENTIAL EFFICACY OF TREATMENT BASED ON TESTING. AND THEN WE CAN MAKE DECISIONS ABOUT THAT. THEN THAT IS DIFFERENT HAVING TO WAIT 7 TO 10 YEARS FOR THE DRUG REGULATORY PROCESS TO GO THROUGH. NOT THE SAME SCENARIO. HAVING VALIDATION -- >> IS THIS AN ISSUE YOU FEEL BAG AROUND THIS, THIS IS THE KIND OF THING DANIELLE SAID TAKE TO COALITIONS WE CAN OR WE CAN HAVE ANOTHER GROUP CALL, NOT AT NCRA MEETING BOOGIED OUR HEADS AROUND THIS WITH THE NCI AND TRY TO GET SOME TRACTION AROUND -- I DO FEEL -- >> THINK OF THE WAYS SHE WANTED TO ENGAGE AND FOR US TO DO THE SAMEN OUR SIDE MAKES SENSE. >> THERE'S ISSUES TO PRIORITIZE. THESE ARE ADVOCATES ISSUE, THERE'S NO WAY TO DO ALL OF THEM AT THE SAME -- BE LIKE NINE NUMBER ONE PRIORITY ISSUES. THERE'S NO WAY TO DO IT. WITH ALL THE OTHER ISSUES LIKE FIGHTING FOR APPROPRIATIONS. SO HOW DO WE PRIORITIZE HERE. CLINICAL TRIALS EDUCATION, THAT'S OBVIOUSLY A BIG ONE. I CAN SPEAK FOR US, BRAIN TUMORS THAT WE'RE REALLY WORRIED THAT BRAIN TUMOR PATIENTS TO YOU ARE YOU POINT MARY ANN, SOME HOSPITALS ARE NOT DOING PATHOLOGY TO FIND OUT IF GLIOBLASTOMA HAS -- IS EGFR MUTATED. THAT'S 60% OF GLIOBLASTOMA PATIENTS, YOU DON'T FIND THAT OUT, YOU DON'T KNOW WHICH PRECISION MEDICINE TRIALS ARE ELIGIBLE FOR. SO THAT'S A PROBLEM. SO HOUSTON WE HAVE A PROBLEM KIND OF ISSUE. WHY DON'T WE TAKE THIS, GO AHEAD SUE. >> SORRY. I HAD A QUESTION, WE HEAR STATISTICS 5% OR LESS THAN 5% OF ADULT CANCER PATIENTS PARTICIPATE IN CLINICAL TRIALS. I WAS WONDERING HOW MANY OF THEM WOULD BE ELIGIBLE AND HOW MANY PATIENTS OVERALL OF ALL THE PATIENTS THAT THEY'RE TRYING TO ENROLL, DOES THAT REPRESENT? BECAUSE THAT NUMBER JUST IS HARD FOR ME TO WRAP MYSELF AROUND WHEN, NOT AS MEANINGFUL TO ME. I WAS WONDERING IF ANYONE -- HOW MANY ADULT CANCER PATIENTS WE NEED TO FILL THE CLINICAL TRIALS OR WHAT PERCENT WILL BE ELIGIBLE FOR CLINICAL TRIALS. >> I DON'T HAVE THAT NUMBER BUT I CAN DO DILIGENCE ON OUR END TO SEE WHAT OUR BEST IDEAS AROUND THAT WOULD BE. >> NOT SURE ANYONE DOES BUT PEOPLE WHO HAVE -- >> ELLEN SEIGAL ONE OF THE PRESSING POINTS SHE BRINGS UP IN MEETINGS WHEN IT GETS TO THIS POINT IS CAREFUL NOT TO MAKE AN ASSUMPTION ALL TRIALS ARE GOOD, IT'S ONE OF THE RIGHT TRIALS >> I THINK THAT'S THE ISSUE. HELLO. >> IS THAT YOU JUNE? >> THAT'S ME. SORRY. >> YOU HAVE THE FLOOR. >> I REALLY APPRECIATE THE QUESTION. I THINK THE CHALLENGES ARE EXACTLY WHAT SOMEONE I THINK SAID BEFORE I DID. IT'S REALLY DIFFICULT TO KNOW WHO (INAUDIBLE) AND ALSO WILL THE TRIAL BE A GOOD TRIAL. SO I WILL SAY WITH RECENTLY WITH A PATIENT WITH BLADDER CANCER, WHO WANTED TO ASK ME TO SEE CLINICAL TRIALS THAT WE SEE BE ELIGIBLE AND HE WAS REFERRING TO TRIALS.GOV AND ALSO CLINICALTRIALS.GOV AND ALSO I WOULD ACTUALLY SPEAK WITH COLLEAGUES OF MINE AT NCI BUT A NUMBER OF SCENES ARE SURPRISING BUT IT IS REALLY QUITE TRUE. THE PERCENT IS SMALL. AND IT CONTINUES TO BE SMALL EVEN AS CLINICAL TRIALS TRY HARD TO RECRUIT PEOPLE INTO THOSE TRIALS, IT WILL CONTINUE TO BE A CHALLENGE, WHAT WE CAN DO OTHER STRATEGIES USING THE INTERNET, WE HAVE TO GO OUTSIDE OUR COMFORT ZONE AND OUTSIDE TRADITIONS THAT WE HAVE USED. WHAT WE HAVE USED IS REALLY NOT BRINGING PEOPLE AT LEAST IN (INAUDIBLE). EVERY TRY TO MEET CRITERIA, TRY TO BRING THIS PRIOR POPULATION IN, DIVERSE POPULATIONS AND IT'S REALLY DIFFICULT, IT'S A BIG CHALLENGE. >> APPRECIATE THAT COMMENT. WE HAVE AN ACTION ITEM FROM THIS CONVERSATION. AND THAT IS TWO FOLD. ONE, WE'LL TALK ABOUT IN OUR OWN RESPECTIVE COALITIONS, WHAT WE TALK ABOUT HERE TODAY. DO THE SAME AT THE NCI. LET'S -- WE CAN HAVE A MINI CALL ABOUT THIS, NOT ALL DAY TELECONFERENCE BUT A ONE HOUR GROUP CALL ON THIS. IN SAY A MONTH AFTER WE HAVE TALKED TO OUR RESPECTIVE COALITIONS. SO THAT IF WE HAD 30 DAYS HOME WORK ASSIGNMENT TO GO BACK, SEE WHERE THIS SORT OF GESTATES WITHIN OUR OWN COALITION AN COME BACK ON THIS SUBJECT. AND COME BACK TO THIS AFTER WE HAVE ASSIMILATED THIS. >> WE SET UP THIS CONVERSATION WITHIN PRECISION MEDICINE THINKING THINKING THAT WAS THE FRAMEWORK WORRYING ABOUT WHICH TIED IN MOLECULAR PROFILE PEOPLE MAYBE NOT READY FOR CLINICAL TRIALS BECAUSE THEY DON'T KNOW THEIR TUMOR WELL ENOUGH YET. TO CONTRAST THAT WITH HEALTH ISSUE KNOWING THINGS AT THE GENOMIC LEVEL ARE NOT AS -- AS IMPORTANT. THE OTHER TAKE A WAY THIS MORNING IS WITH THE RARE TUMOR NETWORK. THAT SOUNDS LIKE THEY'RE GOING TO COME BACK TO US WITH A SPECIFIC HOPEFULLY PARTNERSHIP PROPOSAL OR PLAN HOW TO ENGAGE ADVOCACY GROUPS. BUT ALSO I THINK WHEN I HEARD FROM THEM, IT'S REALLY PRETTY CLEAR INVITATION FOR ANYONE AROUND THIS TABLE WHO WOULD LIKE TO GET A LAYER DEEPER WITH THEM TO PARTNER WITH THEM AND START WORKING WITH THEM TO HELP THEM DO THEIR WORK. AND TO GET INVOLVED WITH DR. GILBERT, DR. ARMSTRONG, DR. WIDEMANN TO GET INVOLVED IN THAT AS AN ADVISOR, AS A PARTICIPANT, AS A PARTNER IN SOME WAY. I THINK WE HAVE TO -- I DON'T THINK WE HAVE TO WAIT UNTIL THERE'S A FORMAL PARTNERSHIP INVITATION TO GET INVOLVED THERE. GET INVOLVED THROUGH AMY. TWO ACTION ITEMS COMING OUT OF THIS MORNING. ANY OTHER ACTION ITEMS THAT >> I WANT TO COMMENT, I THINK WE CAN CONNECT THE DOTS BETWEEN THIS MORNING'S CONVERSATION AND THE AFTERNOON CONVERSATION, IN TERMS OF WHERE WE ARE GOING. PRETTY MUCH MOST CANCERS ARE GOING TO BE RARE CANCER WHEN WE GET INTO PRECISION MEDICINE. IF WE DON'T SOLVE THIS MORNING'S PROBLEM WE DON'T HAVE AN ANSWER TO THIS AFTERNOON'S PROBLEM. >> GOOD POINT. THANKS, RICK. >> ANYBODY HUNGRY? OKAY. WHEN WE GO TO LUNCH THEN WE COME BACK AT -- WHY DON'T WE GO TO LUNCH AND COME BACK AT 1:50. >> YES. SO WE'LL GO TO LUNCH, IT'S ONE O'CLOCK NOW. AT AROUND 1:50, A LITTLE BEFORE 2:00 DOUG WILL BE JOINING US, WE WILL START BACK AT 2:0 BUT WE'RE GOING TO MEET NOT SURE EXACTLY WHERE BUT AS A GROUP FOR GROUP PHOTO WITH DR. LOWY. >> SHOULDN'T WE HUDDLE HERE? RIGHT HERE. WE'LL LOOK FOR YOU BACK HERE AT 1:50. >> GOOD AFTERNOON, EVERYONE. I'M PLEASED TO BE HERE AND TO GIVE YOU AN UPDATE OF WHAT HAS BEEN GOING ON AT NCI SINCE WE LAST MET IN JUNE. I ACTUALLY THINK THAT A LOT HAS BEEN HAPPENING. PERHAPS NOT AS MUCH AS WE MIGHT HOPE BUT STILL REALLY A LOT THAT'S BEEN HAPPENING. I KNOW YOU HAVE ALREADY HAD QUITE A FEW PRESENTATIONS, I'M GOING TO TRY HARD NOT TO BE DUPLICATIVE OF WHAT YOU HAVE ALREADY HEARD. I HAVE A FEW SLIDES AT THE BEGINNING. AND THEN I'M GOING TO GO INTO A NUMBER OF SPECIFIC AREAS THAT ARE IMPORTANT FOR NCI ESPECIALLY SUPPORT FOR NEW GENERATION OF RESEARCHERS. PEDIATRIC AND ADULT MATCH TRIALS, OUR NEW ARRANGEMENT WITH THE VETERANS ADMINISTRATION AND SMALL UPDATE ABOUT THE CANCER MOON SHOT AND ITS CURRENT STATUS. SO BEFORE GOING FURTHER, I WANT TO WELCOME DANIELLE AND RICK TO THE NCRA AND WE APPRECIATE YOUR WILLINGNESS TO PARTICIPATE IN THIS IMPORTANT COUNCIL AND LOOK FORWARD TO GETTING YOUR INPUT AND IDEAS NOT JUST IN THE FORMAL MEETINGS BUT INFORMALLY BEFORE AND AFTER THE MEETINGS OCCUR. SECOND THING THAT I WANT TO DO, A BIG SHOUT OUT AND THANK YOU TO JULIA ROLAND WHO IS GOING TO BE RETIRING FROM THE OFFICE OF CANCER SURVIVORSHIP WHICH SHE HAS ABLY LED FOR THE LAST 18 YEARS SINCE 1999. DURING THAT PERIOD THERE HAS BEEN AN ENORMOUS INCREASE IN THE NUMBER OF CANCER SURVIVORS IN THE UNITED STATES. WE HAVE GONE FROM BEING UNDER 3% OF THE ADULT POPULATION BEING CANCER SURVIVORS TO NOW BEING JUST UNDER 5%. MOST IS ATTRIBUTABLE TO JULIA BUT NOT ALL OF IT. SHE HAS BEEN A STAUNCH STALLWORTH ADVOCATE FOR IMPORTANCE OF SURVIVORSHIP IN AS PART OF THE CANCER RESEARCH ENDEAVOR. SHE HAS BEEN ORGANIZING AND HOLDING CONFERENCES ON CANCER SURVIVORSHIP EVER OTHER YEAR THAT LED TO NEW INITIATIVES, NEW RESEARCH AWARDS, ET CETERA. AND IDENTIFY THE MYRIAD DIMENSION TO SURVIVORSHIP. GREAT TO BE A SURVIVOR BUT WE NEED TO BE MAKING SURE THE MEDICAL ASPECTS ARE ADEQUATELY TAKEN CARE OF AS WELL AS THE SOCIAL AND SOCIO LOGIC ASPECTS AND DOING WHAT WE CAN TO MITIGATE THOSE SO THAT PEOPLE WHO HAVE A DIAGNOSIS OF CANCER AND ARE ABLE TO SURVIVE IT ARE ABLE TO THEN AS MUCH AS POSSIBLE GO BACK TO LIVING THEIR NORMAL LIVES. JULIA, WE ARE IN YOUR DEBT FOR ALL OF THE EFFORTS THAT YOU HAVE MADE DURING THIS PERIOD. THANK YOU. >> THIS IS FROM ONE OF HER RECENT PAPERS SHOWING YOU THE DRAMATIC CHANGE IN THE -- IN SURVIVORSHIP BETWEEN MID 1970s AND NOW. THEN WHAT'S PROJECTED OVER THE NEXT 25 YEARS, NOTHING SHORT OF REMARKABLE. BUT REALLY GOING TO HAVE A LOT OF PEOPLE LIVING WITH CANCER AND WE NEED TO BE SURE THAT WE ARE ADDRESSING ALL OF THEIR NEEDS TO THE EXTENT POSSIBLE. SINCE THE LAST TIME WE MET, THE TRUMP ADMINISTRATION ANNOUNCED THAT NED SHARPLESS IS GOING TO BECOME NCI DIRECTOR. HE'S BEEN DIRECTOR OF THE NCI DESIGNATED CANCER CENTER AT THE UNIVERSITY OF NORTH CAROLINA AND REALLY IS JUST WAITING FOR FINAL VETTING FOR APPROVAL BEFORE HE BECOMES THE NCI DIRECTOR. DURING THIS PERIOD HE AND I MET MULTIPLE TIME, WE ARE MEETING THIS AFTERNOON AFTER THE CONFERENCE IS OVER. FOR EXAMPLE, HE HAS ASKED ME TO STAY ON AS THE PRINCIPLE DEPUTY DIRECTOR OF NCI AND I AM ENTHUSIASTICALLY DOING SO BECAUSE I REALLY THINK THAT WE WILL BE ABLE TO WORK VERY EFFECTIVELY TOGETHER HOWEVER, WHILE WE ARE WAITING FOR DR. SHARPLESS TO ASSUME POSITION OF NCI DIRECTOR, WE ARE GOING FORWARD, WE ARE MAKING DECISIONS AND WE ARE PLANNING FOR THE FUTURE. TY AM VERY MUCH LOOKING FORWARD TO HIS BECOMING DIRECTOR BUT -- CANCER IS TOO IMPORTANT TO WAIT IN TERMS OF FUTURE PLANNING DEAN SIGNATURES MAKING. A -- AND DECISION MAKING. A WORD ABOUT THE HURRICANES THAT HIT THE LAST MONTH. NEEDLESS TO SAY, A TERRIBLE TOLL IN TERMS OF LIFE AS WELL AS SO MANY PEOPLE BEING STRANDED LEFT HOMELESS, ET CETERA. WITHIN THE NCI WE ARE LOOKING AT IT FROM A VERY SMALL ASPECT BUT ONE THAT IS POTENTIALLY IMPORTANT WHAT IS THE IMPACT ON AWARDEES IN TERMS OF THEIR CANCER RESEARCH? AND STEVEN WHITE DIVISION OF CANCER BIOLOGY UNFORTUNATELY IS A VETERAN OF THESE KINDS OF NATURAL DISASTERS AND HE HAS BEEN REALLY REACHING OUT TO THE DIFFERENT AREAS INFLUENCED BY THIS. WE DON'T YET HAVE ANY KIND OF GOOD EVALUATION IN PUERTO RICO BUT THE ISSUES IN FLORIDA, AND IN THE USE THUS FAR AFFECTED JUST RESEARCHERS AT THE UNIVERSITY OF HOUSTON BUT WE ARE CONTINUING TO MONITOR THIS. MK HOLOHAN TALKED WITH YOU EARLIER TODAY ABOUT THE CONTINUING RESOLUTION AND START OF FY 18, SATURDAY, IT IS EXTREMELY BENEFICIAL FOR US THAT WE DO NOT NEED TO WORRY ABOUT A GOVERNMENT SHUT DOWN AT THE END OF THIS WEEK. SEVERAL YEARS AGO I WAS IN THE UNFORTUNATE SITUATION OF BEING IN SUCH A -- BEING IN SUCH A SITUATION WHERE THERE WASN'T FORMAL GOVERNMENT SHUTDOWN BUT BECAUSE THERE WASN'T FUNDING FRIDAY NIGHT AND I WAS SUPPOSED TO LEAVE SATURDAY MORNING TO GO TO THE CONFERENCE, I COULDN'T GO BECAUSE IT WAS AGAINST THE LAW TO ISSUE MY PLAIN TICKET JUST TO GIVE YOU ONE PERSONAL ANECDOTE. THE CONTINUING RESOLUTION AS EXPLAIN INCLUDES FUNDING FOR THE CANCER MOON SHOT AND IN THE LATTER PART, I WILL BE GIVING YOU AN UPDATE ABOUT THAT. I NOW WANT TO DEAL WITH FIRST OF THE MORE GENERAL THEMES AND WHEN I FINISH THE PRESENTATION THERE SHOULD BE PLENTY OF TIME FOR US TO HAVE A GIVE AND TAKE WITH QUESTIONS AND COMMENTS. BACK AT THE BEGINNING OF JUNE WHAT THE NIH WAS PROMOTING WAS THE GRANT SUPPORT INDEX FOCUSED ON REDUCING THE NUMBER OF INVESTIGATORS WHO HAD MANY GRANTS AND IT WOULD INDIRECTLY HAVE IMPACT WITH TRYING TO HELP MORE YOUNGER RESEARCHERS. THEY POSTED QUICKLY -- PAVE -- PIVOTED QUICKLY ABOUT THE GRANT SUPPORTEN DECKS WHAT THEY NOW ARE ADVOCATING, THE SO CALLED NEXT GENERATION RESEARCH INITIATIVE OR NGRI. AND THE FOCUS IS INCREASING SUPPORTS FOR EARLY STAGE INVESTIGATORS OR SO CALLED ESIs, AND FOR EARLY ESTABLISHED INVESTIGATORS OR EEIs, AT THE NCI WE HAVE TAKEN A LOOK TO TRY THE DO A DEEP DIVE INTO WHAT IS HAPPENING, WHO O OUR AWARDEES FROM A DEMOGRAPHIC PERSPECTIVE, AND ALSO IN TERMS THEIR AGE, AND I WANT TO GIVE YOU PART OF A PRESENTATION THAT WAS MADE BY MICHELLE BENNETT AT THE NATIONAL CANCER ADVISORY BOARD AND BOARD OF SCIENTIFIC ADVISORY MEETING. I HAVE HER SLIDE, IF ANY OF YOU WANT TO SEE THE ENTIRE PRESENTATION YOU CAN GO TO THE JOINT BOARD MEETING AND SEE ALL OF IT. THIS IS WHAT THE NIH PRESENTS FREQUENTLY AS THE SOURCE OF THE EARLY INVESTIGATORS, INVESTIGATORS UNDER AGE 45 HAS GONE DOWN SINCE THE -- SINCE 1990. WITH SOME STABILIZATION HERE STARTING AROUND 2005 OR SO. AND WITH THIS GRAPH IT LOOKS AS THOUGH THERE IS NOT MUCH CHANGE FOR THE GREEN LINE WHICH IS PEOPLE IN MID CAREER, WHERE PEOPLE IN THEIR LATER STAGES OF THEIR CAREER, THERE SEEMS TO BE THIS GOES UP AND THIS GOES DOWN. SEW WE WANTED TO LOOK AT THIS FOR NCI AND MY INTERPRETATION IS WE DO HAVE A DECREASE IN INVESTIGATORS UNDER AGE 45, BUT WE HAVE HAD LESS PRESIP AT THIS INCREASE IF YOU WILL OAR ACUTE INCREASE IN THE OLDER INVESTIGATORS. WE ARE GOING FROM OLDEST TO YOUNGEST FIVE YEAR GROUPS. THIS IS FROM 1990 THROUGH 2015. YOU CAN SEE INVESTIGATORS OVER 65, THERE HAS BEEN AN INCREASE BUT THE INCREASE HAS NOT BEEN AS STEEP AS NIH WIDE. WE HAVE HAD INCREASE IN INVESTIGATOR WHOSE ARE 60 TO 64 AND INCREASES IN INVESTIGATORS WHO ARE BETWEEN 50 AND 59. WE START GETTING A LEVELING OFF FOR THE INVESTIGATORS WHO ARE 45 TO 49. AND WE SEE FOR THE INVESTIGATORS WHO ARE IN THEIR EARLY 40 EGGS, IT REALLY HAS BEEN A LEVELING OFF BEFORE 2000. AND A SUBSTANTIAL INCREASE IN INVESTIGATORS OVER 40. OUR OWN PERSPECTIVE IS THE PRINCIPLE REASON FOR THIS DECREASE IS BECAUSE THE TRAINING PERIOD FOR INVESTIGATORS HAS GONE UP SUBSTANTIALLY DURING THIS PERIOD. THERE WERE MULTIPLE FACTORS THAT ACCOUNT FOR IT. YOU CAN SEE THE TOTAL NUMBER OF INVESTIGATORS HAS GONE UP FROM -- IN 1990 A LITTLE MORE THAN 2000 TO IN 2016 MORE THAN 4700. THESE ARE DATES THAT MIGHT BE OF INTEREST TO YOU, SUPER IMPOSED ON THESE CURVES. SO MANDATORY RETIREMENT AT A CERTAIN AGE WAS I LIMBNATED IN THE -- ELIMINATED IN THE MID 1990s AND THIS CONTRIBUTED IMPORTANTLY TO THE PEOPLE OVER 65. THE NIH DOUBLING OCCURRED IN 1998 TO 2003. THE PRINCIPLE BENEFICIARIES WERE DOUBLING OF PEOPLE OVER 45. OUR MONEY, THIS WAS INFUSION OF FUNDS IN 2009 AND 10. THE NCI GOT A BILLION DOLLARS BETWEEN THOSE TWO PERIODS AND NOT THAT MUCH CHANGED, A LOT WENT TO NEW INITIATIVES RATHER THAN TO INVESTIGATOR INITIATED RESEARCH. THIS WAS THE SEQUESTER IN TO 13. 2013. THIS IS THE SNAP SHOT THAT WE HAVE AND AND WHAT I WOULD LIKE TO LEAVE YOU WITH IS THAT WE ARE FOR FY 17 INCREASING THE NUMBER OF INVESTIGATORS WHO ARE DEEMED EARLY STAGE INVESTIGATORS, THESE ARE INVESTIGATORS WHO HAVE NEVER HAD A MAJOR GRANT FROM NIH, NOT JUST NCI BUT FROM ALL OF NIH. WE'RE AIMING TO GO UP BY AROUND 10% OR SO COMPARED TO WHAT WE DID IN 2016. WHILE TAKING A MORE SYSTEMATIC LOOK AT OUR RESEARCH PORTFOLIO AND TRYING TO PROJECT FORWARD WHAT WOULD BE AN OPTIMAL NUMBER OF INVESTIGATORS TO HAVE AS WELL AS SOME OTHER POTENTIALLY IMPORTANT PARAMETERS, HAPPY TO DISCUSS THINGS AFTERWARDS DURING THE DISCUSSION PERIOD. I SHOWEDDED YOU THE SLIDE LAST JUNE, IT IS MY WAY OF INTRODUCING YOU TO THE NCI MATCH TRIAL AND I MENTIONED IN JUNE HOW ON A PER CAPITA BASIS THIS IS TRULY A NATIONAL TRIAL WHERE A LOT OF THE PATIENTS ARE COMING FROM AREAS THAT DON'T HAVE NCI DESIGNATED CANCER CENTERS. SO THE ENROLLMENT AS OF A COUPLE OF WEEKS AGO, REALLY HAS GONE OVER THE 6,000 THAT WE WERE AIMING TO GET. WE HAD INITIALLY PLANNED IN 2015 TO HAVE ONLY 3,000 PEOPLE ENROLLED IN THE MATCH TRIAL. BUT BECAUSE OF THE INCREASE FUNDING FOR THE PRECISION MEDICINE INITIATIVE IN ONCOLOGY, AS WELL ADS THE RAPID ACCRUAL IN THE TRIAL WE DOUBLED THAT. I HAVE THIS MORE THAN 5482 RECEIVE THEIR TEST RESULTS BECAUSE THE DATA THAT I HAVE IS NOT TOTALLY UP TO DATE AND IT'S OUT OF DATE -- I DON'T KNOW HOW MUCH BIGGER THAT NUMBER IS. BUT BASICALLY JUST UNDER A THOUSAND PATIENTS, A LITTLE LESS THAN 1 IN 6 PATIENTS HAD A GENE ABNORMALITY MATCHING AVAILABLE TREATMENT. JUST UNDER 700 PATIENTS, 70% ELIGIBLE PATIENTS HAVE ENROLLED IN ONE OF THE MORE THAN 30 TREATMENT ARMS FOR THE ADULT MATCH TRIALS. THEY WERE INITIALLY 25 BUT IN MARCH OF THIS YEAR WE ADDED SIX MORE. HALF OF THOSE ARMS ARE FULLY ACCRUED, 25% AROUND -- BUT A QUARTER OF THEM NEED ADDITIONAL FROM THE RARE VARIANT STUDY, I HAVE A SLIDE ABOUT THE RARE VARIANT STUDY SHORTLY. ASSAY SUCCESS RATE HAD BEEN OVER 90%, WE ARE NOT AWARE OF ANY OTHER MULTI-CENTER TRIAL WHERE SUCH A SUCCESS RATE HAS BEEN SEEN. THE MEDIAN ASSAY TURN AROUND TIMES JUST OVER TWO WEEKS, THE TREATMENT TOXICITY IS ACCEPTABLE AND THERE'S OBJECTIVE RESPONSES. WE DON'T HAVE THE ANALYSIS YET, THOSE ANNEAL SEIZE WILL BE THE FIRST ANALYSES ABOUT THE RESPONSE RATES FOR DIFFERENT ARMS WILL BE COMING OUT IN THE END OF THE FOURTH QUARTER OF THIS YEAR. THE WAY THE MATCH TRIAL IS DESIGNED IS THERE'S POTENTIAL INPUT FOR RAPID INCREASE IN NUMBER OF PATIENTS FOR A RELEVANT ARM. SO IF THERE IS NOT A SIGNAL THAT LOOKS AS THOUGH SOMETHING IS WORKING. WE CAN RAPIDLY INCREASE THE -- THOSE ARMS. SO A MORE CAREFUL EVALUATION CAN BE MADE. I'M NOT GOING TO GO THROUGH ALL OF THIS SLIDE BUT TO TELL YOU ABOUT THE RARE VARIANT INITIATIVE AND SIMPLY TO REPEAT WHAT I SAID, WHICH IS THAT ABOUT A QUARTER OF THE ARMS ARE NOT EXPECTED TO FULFILL BECAUSE OF THE RARITY OF THE RARITY IN THE POPULATION. STILL EVIDENCE THESE DRIVERS OF CANCER MIGHT RESPOND TO DRUGS IN THE TRIAL, SO IT'S REALLY OPENING UP THE MATCH TRIAL TO MORE PATIENTS, SPECIFICALLY FOR THESE ARMS THAT ARE UNDERACCRUING AND TO ENRICH FOR SEVERAL ADDITIONAL CLIA CERTIFIED LABS BUT THE PLAN IS TO GO FOR A PROCESS OF QUALIFYING OTHER COMMERCIAL ACADEMIC SEQUENCING LABS TO ENCOURAGE ADDITIONAL ACCRUAL TO THIS PHASE OF THE NCI MATCH TRIAL. SO THIS IS ANOTHER -- IF YOU WILL FOLLOW-UP TO THE MATCH -- TO THE ADULT MATCH TRIAL. IN JULY WE STARTED THE NCI PEDIATRIC MATCH TRIAL AND IT IS AGAIN, THERE ARE MULTIPLE INHIBITORS THAT ARE BEING TESTED IN MULTIPLE ARMS, THESE ARE FOR CHILDREN WITH RELAPSE REFRACTORY SOLID TUMORS AND LYMPHOMAS. AND THE TRIAL HAS ACTUALLY STARTED TO ACCRUE PATIENTS TO IT. ONE OF THE BIG DIFFERENCES BETWEEN THE PEDIATRIC MATCH STUDY AND THE ADULT MATCH STUDY WAS THE NEED TO HAVE RIGOROUS ASSESSMENT OF THE GERM LINE CONFIGURATION OF THE CHILDREN WHO DEVELOP CANCER. IN ADULTS, TENDS TO BE LESS IMPORTANT GERM LINE CON FILLING RATION BUT A SUBSET OF CHILDREN WHO DEVELOP CANCER THIS PART, THE GERM LINE CONFIGURATION IS A VERY IMPORTANT CONSIDERATION BECAUSE OF PRE-DISPOSING MUTATIONS THAT ACCOUNT FOR THE DEVELOPMENT OF THE CANCER. NEEDLESS TO SAY IT IS EARLY DAYS FOR THE MATCH BUT WE ARE VERY PLEASED THAT IT IS UNDERWAY. THE SECOND MAJOR AREA I WANTED TO DISCUSS IS A VERY RECENT AGREEMENT THAT HAS BEEN MADE BETWEEN THE NCI AND VETERANS ADMINISTRATION. THE PURPOSE OF IT IS MAINLY TO ACCELERATE TRIAL ENROLLMENT AND AS I HAVE OBSERVED PREVIOUSLY, WE'RE INSIDE THE BELTWAY, SO WE MUST HAVE AN ACRONYM FOR WHAT WE ARE DOING. THIS IS CALLED THE NAVIGATE -- I'M REFERRING YOU TO SHEILA PRINDIVILLE'S PRESENTATION BECAUSE I'M JUST SHOWING A FEW OF HER SLIDES FOR THOSE WHO ARE INTERESTED, THIS WAS DONE AT ONE OF OUR OTHER ADVISORY COUNCIL MEETINGS, CLINICALLY -- CLINICAL ADVISORY COUNCIL. THERE ARE MANY GROUPS OF PEOPLE IN THE NCI AS WELL AS AT THE VA WHO HAVE MADE IMPORTANT CONTRIBUTIONS FOR MAKING THIS -- MAKING THIS POSSIBLE. LET ME SHOW YOU THE POTENTIAL AND TALK ABOUT THE PROBLEMS AND BRIEFLY TELL YOU ABOUT THE SOLUTIONS GOING FORWARD. FIRST, THE VA HAS -- PEOPLE IN THE VA SYSTEM DEVELOP MANY CANCERS AND THIS IS FOR A -- THIS IS FOR A RECENT YEAR IN 2010 T. JUST UNDER 50,000 CANCERS IN THE V A SYSTEM, NEEDLESS TO SAY IT IS HEAVILY SKEWED TOWARD CANCER ARISING IN MEN, A SMALL PERCENTAGE ARE ARISING IN WOMEN. IN ADDITION IN ADDITION THERE'S HIGH PERCENTAGE OF MINORITIES ESPECIALLY AFRICAN AMERICANS WHO ARE IN THE VA. AND OUR GENERAL ACCRUAL RATE FOR AFRICAN -- MINORITY ENROLLMENT FOR OUR TRIALS IS ABOUT 20%. ONLY A LITTLE OVER HALF THAT ACCRUAL RATE IS IN AFRICAN AMERICANS SO THIS IS SUBSTANTIALLY HIGHER THAN WHAT WE SEE. IN OUR ACCRUAL RATE. THE OTHER THING I POINT OUT IT'S A LOT OF PATIENTS COME FROM SOME AREAS, THESE ARE AREAS OF HIGH CANCER INCIDENCE WHERE THERE IS OFTEN LESS RESEARCH KNOWN AND LESS ACCESS TO CLINICAL TRIALS. BARRIERS TO VA PARTICIPATION WERE MULTIPLE. ONE WAS REGULATORY AND POLICY COMPLIANCE ISSUES, WHEN WE STARTED THE VA WOULD NOT RECOGNIZE THE -- OUR IRB, NCI HAS THIS SINGLE IRB FOR NATIONAL -- FOR NATIONAL TRIALS SO WE HAD TO WORK THROUGH HOW TO RECONCILE IF YOU WILL THE REGULATORY ASPECTS FOR THE VA AND THE REGULATORY COMPLIANCE ASPECTS FOR THE NCI. THERE WERE OTHER ISSUES AND IMPORTANTLY LACK OF PERSONNEL AND RESOURCES FOR RECRUITMENT. AGAIN, WE GOT AROUND THIS BY PROVIDING VETERANS ADMINISTRATION WITH SOME FUNDING, SO THEY CAN PARTICIPATE IN THE TRIALS. AND OTHER ISSUES PARTICIPATION. SO THE OVERALL GOAL IS TO ENABLE MORE PATIENTS TO ENROLL NCI NATIONAL CLINICAL TRIALS AND THE INITIAL FOCUS ON ACTIVITY TO FACILITATE PARTICIPATION OF THE VA MEDICAL CENTER SITES IN NCI TRIALS, THE LONGER TERM GOALS INCLUDE SEEKING WAYS TO SUSTAIN THE -- THEIR PARTICIPATION BEYOND INTERINSTITUTE AGREEMENT THAT WE -- INTERAGENCY AGREEMENT THAT WE HAVE DEVELOPED WITH THE VA. THERE'S REALLY TOOK A LOT OF EFFORT ON BOTH SIDES, AND BOTH THERE WERE NO AGREEMENTS BEFORE. LET ME TELL YOU, IN A -- IN RECENT PERIODS OF THE 45,000 OR SO PATIENTS, FROM THE VA ON TRIALS ABOUT HUNDRED PER YEAR WILL BE PARTICIPATING IN THE NCI TRIALS BEFORE WE DID THIS. THE PRIMARY ACTIVITY SUPPORTED PROVIDE INFRASTRUCTURE FUNDING AS I MENTIONED AND THERE'S AN EXECUTIVE COMMITTEE TO OVERSEE THE ACTIVITIES AND HELP CONTINUE TO OVERCOME BARRIERS. AND THE BENEFITS ARE GOING TO BE SUBSTANTIAL. MOST IMPORTANTLY INCREASING ACCESS FOR VETERANS ACCELERATING APPROVAL, MINORITY POPULATION, VA CLINICAL INVESTIGATORS IS GOING TO HELP THEM PARTICIPATE IN NCI SCIENTIFIC STEERING COMMITTEES AN ENHANCE VAs OVERALL LEADER SHIP ROLE IN CANCER CARE. AND CLINICAL RESEARCH. AND WE ARE IN THE PROCESS OF DOING THIS, THE EXECUTIVE COMMITTEE IS ACTUALLY GOING TO BE FORMED NEXT -- WE HOPE NEXT MONTH. AND WE WILL RELEASE SOLICITATION TO FIND FUNDING FOR 8 TO 10 SITES AND TRY IN THE SPRING TO HAVE A KICK OFF MEETING WITH THOSE SITES. THE LAST TOPIC I WANT TO DISCUSS IS CANCER MOON SHOT, THE WAY THE PANEL RECOMMENDATIONS THAT WERE MADE LAST YEAR. AND THE FUNDING WE RECEIVED IN DECEMBER LAST YEAR WHILE CURRENT FISCAL YEAR WAS IN PROGRESS AND WHAT WE HAVE DONE ABOUT THIS. I HAVE TWO SLIDES ON THE STATUS OF FY 17 INITIATIVES. FIRST THE RFAs PUT OUT THERE'S SEVERAL RFAs THAT YOU CAN SEE HERE HAVE GONE OUT AND THAT WILL BE FUNDED BY THE END OF THIS WEEK. IN ADDITION THERE'S PARTNERSHIPS CONTRACTS AND SUPPLEMENTS AND THEY ARE ALSO INITIAL FUNDING IS GOING TO BE MADE BY THE END OF THIS WEEK. MUCH OF THIS FUNDING HAS ALREADY BEEN DONE BUT I WANT TO MAKE SURE THAT YOU ARE AWARE OF THIS. THE DEPARTMENT OF ENERGY COLLABORATIONS WITH PREDICTIVE MODELING. I WAS AT ORANGE LIVERMORE LABORATORIES ONE DEPARTMENT OF ENERGY LABORATORY TWO WEEKS AGO, REALLY PRESENTING EXCITING INTERESTING STUFF, WE'RE WORKING TOGETHER I THINK WE'RE GOING TO ACCOMPLISH THINGS WOULD CERTAINLY OUT OUT THE DEPARTMENT OF ENERGY WE WOULD BE MAKING THE PROGRESS THAT WE ARE MAKING. THE SMOKING CESSATION PROGRAM BOB CROYLE IS HERE, WE PUT OUT SUPPLEMENTS TO THE CANCER SENTs FOR TRYING TO DEVELOP SMOKING CESSATION. THAT'S GOING TO BE FOCUSED NOT JUST ON OVERALL SMOKING CESSATION BUT ESPECIALLY FOCUSED ON PATIENTS WITH RECENTLY DIAGNOSED CANCER BECAUSE THERE IS GOOD EVIDENCE CURRENT SMOKERS WHO HAVE RECENTLY DIAGNOSED CANCER IF THEY STOP SMOKING THEY WILL HAVE A BETTER OUTCOME. SO JUST ONE OF SEVERAL AREAS. UNDER POINT OUT WE HAVE TWO INITIATIVES AIMED SPECIFICALLY TOWARDS PEDIATRIC CANCER AND SPECIFICALLY TOWARDS DEVELOPING BETTER TREATMENT FOR CHILDREN WITH PEDIATRIC CANCER ONE WITH IMMUNOTHERAPY AND THE OTHER WITH TARGETED TREATMNT AGAINST FUSION PROTEINS THAT ARE PLAYING AN IMPORTANT ROLE IN THEM. I SHOULD ALSO POINT OUT WE ARE DOING A RESEARCH DEMONSTRATION PROJECT IN KENTUCKY THAT IS -- THAT HAS JUST BEEN FUNDED, BUT THIS IS ACTUALLY A THREE-WAY COLLABORATION BETWEEN NATIONAL INSTITUTE ON DRUG ABUSE HERE AT NIH AND CENTERS FOR DISEASE CONTROL. IT'S A DEMONSTRATION PROJECT IN SMALL TOWN IN EASTERN KENTUCKY AMONG PEOPLE WHO ARE HEPATITIS C VIRUS POSITIVE, OPIOID DRUG USERS IF WE CAN ESSENTIAL WILL BY TREATING OPIOID ABUSE AND TREATING HEPATITIS C VIRUS INFECTION SUBSTANTIALLY REDUCE OPIOID REDUCE AND DRAMATICALLY REDUCE NOT JUST PREVALENCE OF HEPATITIS C VIRUS INFECTION BUT ALSO THE INCIDENCE OF HEPATITIS C INFECTION. IT IS PROJECTED OVER THE NEXT 15 TO 20 YEARS THE SINGLE BIGGEST RISE IN CANCER INCIDENCE AND MORTALITY WILL COME FROM LIVER CANCER AND MAJOR DRIVER OF THAT CHANGE. IS CHRONIC HEPATITIS C VIRUS INFECTION. THESE ARE ALREADY PLANNED FOR FY 18 AND YOU CAN SEE WHY I AM ESPECIALLY GRATEFUL TO CONGRESS FOR HAVING PROVIDED FUNDING FOR THE CANCER MOON SHOT FOR FY 18. BECAUSE IT IS AN AMBITIOUS PROGRAM WHERE WE ARE EXPECTED TO BE FUNDING IN VIRTUALLY ALL TEN AREAS THAT WERE -- RECOMMENDED. FOR EXAMPLE, A COUPLE ARE EMPTY RETROSPECTIVE ANALYSIS BIOSPECIMENS, AND IT'S EMPTY BECAUSE WE HAVE PUT FUNDING ASIDE FOR THAT IN FY 17. BUT WE HAVEN'T DECIDED WHAT STUDIES ARE GOING TO BE USED FOR THE DETAILED MOLECULAR ANALYSIS. WE FIND OURSELVES IN A SITUATION WHERE WE HAVE SOME COMPLETED STUDIES WHERE WE HAVE EXCELLENT ANNOTATION WHAT PATIENTS ARE TREATED WITH, WHAT THE RESPONSE WAS, OUT. WE DON'T HAVE GOOD MOLECULAR ANALYSIS. CONVERSELY WE HAVE STUDIES WHERE THERE'S GOOD MOLECULAR ANALYSIS BUT WE DON'T HAVE GOOD CLINICAL ANNOTATION. AND IT'S FAR EASIER TO -- IF WE CAN HAVE ACCESS TO THE BIOSPECIMENS TO DO THE MOLECULAR ANALYSIS OF THOSE COHORTS WHERE WE ALREADY HAVE GOOD CLINICAL ANNOTATION TO DO MOLECULAR ANALYSIS. THAT'S ONE OF THOSE AREAS. I TRIED TO GIVE YOU THEOVER VIEW OF SOME OF THE HIGHLIGHTS OF WHAT -- WHAT HAD BEEN GOING ON. BUT I REALLY WANT US TO MAKE SURE WE HAVE PLENTY OF TIME FOR DISCUSSION SO I'LL STOP HERE AND ENTERTAIN YOUR COMMENTS AND QUESTIONS. THANKS VERY MUCH. [APPLAUSE] >> THANK YOU, DR. LOWY. I WANTED TO YOUR WORDS THANKS TO JULIA ROLAND. WE ARE SO GRATEFUL FROM ALL OF US IN ADVOCACY COMMUNITY, THANK YOU FOR ALL THAT YOU HAVE DONE FOR SURVIVORS AND FOR SURVIVORSHIP. AMAZING HOW THE FIELD HAS GROWN AND SINCE YOU TOOK OVER THIS OFFICE WE WILL MISS YOU VERY MUCH. GRATEFUL FOR ALL THAT YOU HAVE DONE AND LOOK FORWARD TO SEEING WHAT YOU DO NEXT -- IN YOUR NEXT LIFE AFTER LEAVING THE NCI. VERY SAD BUT GRATEFUL. SEE IF YOU WANT TO TALK A LITTLE BIT ABOUT THE PLANS FOR THE OFFICE AFTER JULIA RETIREMENT THIS WEEKEND. I KNOW THERE'S A SEARCH COMMITTEE. >> ONE OF MY PRINCIPLES IS I LEAVE THE HARD QUESTIONS TO SOMEBODY ELSE AND BOB CROYLE WHO IS THE DIRECTOR OF DIVISION WHERE THE OFFICE RESIDES JUST HAPPENS TO BE HERE. >> THANKS. SO THE OFFICE HAS EVOLVED AND IT'S ROLE AND FUNCTION OVER THE YEARS, ONE ANNA MEADOWS THE ORIGINAL DIRECTOR ON AN ACTING BASIS I THINK WE HAD A GRANT PORTFOLIO AND THAT'S GROWN A LOT T. ONE OF THE CHALLENGES MOVING FORWARD IS WE HAVE NOW ESTABLISHED ONE OF THE PRINCIPLE GOALS INITIALLY OF CREATING THE OFFICE GROWING A PORTFOLIO OF NCI AND SURVIVORSHIP, WHEN THE OFFICE STARTED MOST WORK ON SURVIVORSHIP IS PSYCHOSOCIAL FOCUSED. DIVERSIFIED INTO EPIDEMIOLOGICAL RESEARCH CLINICAL AND MEDICAL RESEARCH, LONG TERM SURVIVORS, WE HAD ALMOST NO DATA AT THE TIME. FIRST TWO RFAs FOCUSED ON LONG TERM SURVIVORS AND THEIR OUTCOMES. SO IN TERMS OF GROWTH OF THE PROGRAM, THAT IS HAPPENED. THOSE GRANTS ARE NOW MANAGED IN THE PROGRAMS AND THOSE DIFFERENT DISCIPLINES AT BEHAVIORAL SCIENCE WHATEVER IT MIGHT BE. THE LATEST THING THE LAST COUPLE OF THINGS WHAT RESEARCH INFRASTRUCTURE DOES THE INSTITUTE AND THE NATION NEED TO SCALE UP THE AMBITION OF OUR QUESTIONS. SO THE MAJOR CHANGE THE LAST COUPLE OF YEARS WE FUNDED OUR FIRST SERIES OF CANCER SURVIVOR COHORT STUDIES. THERE HAD BEEN ONE LAUNCHING A FEW YEARS AGO BY BETTY CAN AND KEISER AND LARRY KUSHI FOCUSED ON BREAST CANCER, MOST RECENTLY WE FUND AD NEW CANCER SURVIVOR COHORT, LED BY DAVID CHRISTIAN IN MASSACHUSETTS. ANOTHER ONE FOCUS ON AFRICAN AMERICAN POPULATIONS BASED IN DETROIT. SO THIS WAS ONE MISSING PIECE WAS WE HAD INDIVIDUAL GRANT PROJECTS, PROSPECTIVE STUDIES FOLLOWING LARGE GROUPS OF INDIVIDUALS OVER TIME. THE OTHER WAY THAT WE HAVE CHANGED THE PORTFOLIO WAS TO MAKE IT MORE POPULATION BASED, MORE GENERALIZABLE TO THE POPULATION AT LARGE. ONE OF THE STRUGGLES EARLY ON IS FIRST GROUP OF FOLKS SURVIVOR FOCUSED ON BREAST CANCER, BREAST CANCER SURVIVORS, A STRUGGLE TO DIVERSIFY THE RESEARCH COMMUNITY TO LOOK AT OTHER TYPES OF CANCER. THAT'S NOW HAPPEN JUST WITHIN THE LAST FEW YEARS. ONE OF THE MAIN STRATEGIC AREAS WE HAVE BEEN DISCUSSING THIS YEAR, WE'RE RECOMPETING THE SERE REGISTRY CONTRACTS, THOSE NEW CONTRACTS WILL BE AWARDED NEXT YEAR. THOSE OBVIOUSLY ARE POPULATION BASE, GEOGRAPHIC DOMAINS. HOW WE CAN BETTER LEVERAGE THE REGISTRY SYSTEM AS A COMPONENT AS A CANCER SURVIVOR RESEARCH INFRASTRUCTURE. THAT IS PIGGY BACKING ON POPULATION BASED REGISTRIES TO COLLECT DATA ABOUT CANCER SURVIVORS AND A MUCH MORE AMBITIOUS BROADWAY THAN WE HAVE DONE WITH THE FIRST GENERATION OF WORK WHICH IS REALLY CONVENIENCE RECRUITING OF FOLKS PRIMARILY CANCER CENTERS, OFTENTIMES ALREADY ENROLLED IN CLINICAL TRIALS IN NECESSTY EASY TO REACH POPULATION, THE WEAKEST AREA PORTFOLIO WE WOULD HOPEFULLY RECOGNIZE IS DISPARITIES AND UNDERSERVED POPULATIONS AND CANCER SURVIVORS SO THAT CLEARLY WOULD BE ANOTHER GOAL. BUT IN TERMS OF THANK YOU FOR AGREEING TO SERVE ON THE SEARCH COMMITTEE IN REP ON THE SEARCH COMMITTEE IS WE NEED YOUR FEEDBACK AND WE NEED THIS GROUP'S HELP AND RECRUITING AND IDENTIFYING OUTSTANDING PERSON TO LEAD OFFICE OF CANCER SURVIVOR. >> OUR COALITION FROM ALLIANCE, THE QUESTION CAME UP IS THERE PEDIATRIC REPRESENTATION ON THE SEARCH COMMITTEE AS PART OF FORMAL PROCESS? >> ABSOLUTELY. WITH THE CHILDHOOD CANCER STUDY COHORT, WE HAVE ALSO NCI FUNDERS OF THE SAINT JUDE COHORT AS WELL, ANOTHER ISSUE THAT HAS COME UP IS IN ADDITION COMPONENT INFRASTRUCTURE, MINIMAL ESSENTIAL COMPONENT RESEARCH PORTFOLIO, HOW CAN WE ENHANCE THAT AS WELL BECAUSE AGAIN, THAT IS A KEY COMPONENT BE YOU CAN'T ANSWER ALL QUESTIONS IN THOSE. >> THANKS, BOB. I WANT TO MENTION TWO THINGS ABOUT SERE REGISTRY THAT BOB HAS RAISED. THE FIRST IS THAT ALTHOUGH YOU MIGHT NOT SEE IMMEDIATELY WHY DEPARTMENT OF ENERGY WOULD BE KEY FOR DEVELOPING THE IF YOU WILL GETTING US INTO THE 21st CENTURY FOR THE SERE REGISTRY, THIS IS ONE OF THE PROJECTS THAT WE ARE WORKING WITH THE DEPARTMENT OF ENERGY ON. AND THE GOAL REALLY IS TO BE ABLE TO UPLOAD AS MUCH INFORMATION AS POSSIBLE ELECTRONICALLY YOU WOULD BE AMAZED HOW THE SEER REGISTRY HAS REALLY BEEN A COTTAGE INDUSTRY, WHERE MUCH OF THE IS UPLOADED MANUALLY, RATHER THAN IN AN AUTOMATED WAY. THIS IS ONE ASPECT. THE SECOND IS THAT I JUST CAME FROM TALKING WITH A NUMBER OF CONGRESSMEN AND CONGRESS WOMEN WHO ARE VISITING THE NIH THIS AFTERNOON AND ONE IS CONGRESSMAN BUTTERFIELD FROM NORTH CAROLINA. I WAS ABLE TO -- HE'S ON THE HOUSE ENERGY COMMERCE COMMITTEE, I WAS ABLE TO TELL HIM ABOUT OUR COLLABORATION WITH THE DEPARTMENT OF ENERGY NEEDLESS TO SAY HE WAS NOT AWARE OF IT BUT I WAS ABLE TO TELL HIM VERY HONESTLY THAT TOGETHER DOING MORE THAN EITHER OF US ONE ABLE TO DO IN THIS SPACE SEPARATELY. >> THANKS FOR THE UPDATE ON THE MOON SHOT. THE PRESENT. WHAT SHOULD WE AS ADVOCATES BE EXCITED ABOUT IN TERMS OF THE NEXT STAGE OF OF THE MOB SHOT KNOWING THE NCI IS DOING PLANNING FOR 2018, 2019, UNDERSTAND THE MOON SHOT IS VERY MUCH ALIVE AND KICKING AND ROLLING OUT WANT TO UNDERSTAND AS MUCH AS WE CAN GET AROUND IT SUPPORT IT AND AMPLIFY IT. >> DAVID, I THINK THAT THERE REALLY IS A TWO PART MESSAGE. THE FIRST IS THAT THANKS TO THE CANCER MOON SHOT WE ARE ABLE TO SUPPORT RESEARCH THAT OTHERWISE WE WOULD NOT BE ABLE TO SUPPORT AS STRONGLY AS WE ARE SUPPORTING. THE MEMBERS OF CONGRESS WENT TO SEE OUR PROSTATE CANCER IMAGING LABORATORY AND WE'RE TOLD ABOUT A CANCER MOON SHOT EFFORT TO TRY TO HELP THAT GROUP OF PATIENTS WITH PROSTATE CANCER WHO ARE THOUGHT TO HAVE PROSTATE CANCER THAT IS VERY LIMITED. BUT WITH NEW SOPHISTICATED HIGHLY SENSITIVE SPECIFIC IMAGING TECHNOLOGY, WE CAN IDENTIFY PATIENTS WHO ACTUALLY HAVE MORE EXTENSIVE PLASTIC CANCER THAN INITIALLY THOUGHT. AND WE'RE SETTING THIS UP AS AN INTRAMURAL EXTRA MURAL EFFORT THAT ALSO INVOLVES THE DA HOSPITAL TO IDENTIFY THOSE PATIENTS AND THEN TREAT THEM IN A WAY SO THAT WE WANT TO SEE CAN WE CHANGE THOSE -- THE NATURAL HISTORY OF THOSE PATIENTS, MANY OF WHOM END UP DYING UNEXPECT EDLY SO BY TREATING EARLY MIGHT WE CHANGE THAT NATURAL HISTORY. SO THIS IS JUST ONE EXAMPLE IN ADDITION TO THE ONES THAT I MENTIONED. EQUALLY IMPORTANT ASPECT IS HOW CRITICAL REGULAR APPROPRIATION IS. I ALLUDED TO THIS WHEN I TALKED WITH YOU IN JUNE. THIS IS REALLY FOR TWO REASONS. THE FIRST IS THERE'S A TREMENDOUS AMOUNT OF RESEARCH THAT IS SUPPORTED WITH THE REGULAR APPROPRIATION THAT IS NOT SUPPORTIVE BY THE -- BY CANCER MOON SHOT. MOST OF OUR CLINICAL TRIALS PROSTATE CANCER IS AN EXCEPTION BUT MOST OF THEM SUPPORTED BY REGULAR APPROPRIATION VIRTUALLY ALL OUR INVESTIGATOR INITIATED RESEARCH IS SUPPORTED THAT WAY, ALL OF OUR TRAINING IS SUPPORTED THAT WAY. THE SECOND REASON IS WE WANT TO MAKE SURE THAT CONGRESS CONTINUES TO MAKE A DISTINCTION BETWEEN THE REGULAR APPROPRIATION AND THE CANCER MOON SHOT. WE DON'T WANT TO BE IN A SITUATION WHERE CONGRESS SAYS YOU'RE GETTING MONEY FOR THE CANCER MOON SHOT SO WE DON'T NEED TO GIVE NCI AN INCREASE. WE PROJECTED THAT DURING THE SEVEN YEARS OF CANCER MOON SHOT FUNDING, FROM 2017 TO 2023, IF THERE WERE NO INCREASE IN THE NCI BASE BUDGET, THE REGULAR APPROPRIATION THAT BY THE END OF THOSE SEVEN YEARS OUR PURCHASING POWER WOULD BE DOWN ABOUT 25%. SO IT'S CRITICALLY IMPORTANT TO MAKE SURE THAT WE BOTH EMPHASIZE HERE ARE THE GREAT THINGS WE'RE ABLE TO DO THANKS TO THE CANCER MOON SHOT, THAT WE THINK ARE GOING TO REALLY ACCELERATE THE PACE OF RESEARCH, HAVE IMPACT SHORTER TIME PERIOD THAN OTHERWISE MIGHT BE POSSIBLE BUT AT THE SAME TIME GIVING EMPHASIS TO THE REGULAR APPROPRIATION BECAUSE THERE'S A LOT OF NON-OVERLAP BETWEEN TWO AND REGULAR APPROPRIATION WHICH REPRESENTS ABOUT 95% OUR FUNDING IS CRITICALLY IMPORTANT FOR WHAT WE DO. >> THIS IS REGINA, I'M SORRY I'M ON THE PHONE I COULDN'T HEAR WHEN YOUR TALKING ABOUT SE,R. ONE OF THE CRITICISMS IN THE PAST IS GEOGRAPHIC LACK OF DIVERSITY SHALL WE SAY, JUST NOT ENOUGH LOCATIONS. I WAS WONDERING IF THAT'S PART OF THE PROCESS OF THE EXPANSION OF IT IN THIS NEXT ROUND, IS THERE POTENTIAL FOR GOING TO EXPANDED GEOGRAPHY? >> THERE IS THE POTENTIAL FOR THERE TO BE A CHANGE IN DEMOGRAPHICS. BUT IT REALLY WILL DEPEND ON THE APPLICATIONS HOW THEY FAIR, ET CETERA. WE WANT TO SUPPORT THE BEST PROPOSALS. >> HI, DR. LOWY, I HAVE TWO QUESTIONS ABOUT NEW GENERATION RESEARCH INITIATIVE. IF YOU CAN CLARIFY THE AGE TRENDS (INAUDIBLE) FOR INVESTIGATORS, IS THAT INCLUSIVE OF COMMUNITY BASED RESEARCHERS AND THOSE WHO WORK AT NIH? ALSO IN THE IN THE PLANNING ARE YOU LOOKING AT WAYS TO STRATEGIZE HOW WE CAN ENGAGE MORE -- >> IN THE PLAN -- I'M SORRY. FROM IN THE PLANNING OF THIS INITIATIVE, DOES IT UNCOLLUDE A STRATEGY TO ENGAGE MORE PHYSICIANS IN THE COMMUNITY TO BECOME RESEARCHERS. I THINK I HEAR A LOT THAT A LOT OF PHYSICIANS PRACTICING PHYSICIANS, EXPERTS IN YOUR FIELD OFTEN ESPECIALLY YOUNGER ONES, THAT'S A LOT OF WORK, I DON'T HAVE THE RESOURCES, I DON'T KNOW HOW TO DO IT. SO RECRUITING AND LOOKING AND TARGETING THOSE PART OF COUNTRY, (INAUDIBLE) WOULD BE A GREAT OPPORTUNITY. >> THE ANSWER TO THE WE COULD -- THE ANSWER TO THE SECOND QUESTION REALLY IS THAT THAT'S NOT WHAT THIS INITIATIVE IS ABOUT. THIS INITIATIVE IS REALLY ABOUT PEOPLE WHO ARE TRYING TO GET THEIR OWN MAJOR GRANTS FROM NIH OR NCI AND THE PEOPLE THAT YOU'RE TALKING ABOUT VERY IMPORTANT FOR US TO ENGAGE IN RESEARCH. BUT NOT BY THIS MECHANISM. IN TERMS OF -- THE FIRST QUESTION ONE OF THE HANDICAPS THAT WE HAVE IS THAT WE DON'T HAVE DIRECT ACCESS TO THE AGE OF APPLICANTS. WE ONLY KNOW WHERE THEY STAND IN RELATION TO WHEN THEY GOT THEIR DEGREE OR THINGS LIKE THAT. THE NIH HAS THAT INFORMATION, THEY GIVE IT TO US IN A DEIDENTIFIED MANNER. BUT OUR PERCEPTION IS THERE IS ACTUALLY A LONG LAG TIME FROM THE TIME PEOPLE GET THEIR DEGREES EACH OF THE TIME THEY ACTALLY GET THEIR AWARD. WE ARE ACTUALLY PARADOXICALLY THINKING ABOUT INCREASING THAT AMOUNT OF TIME IN TERMS OF THE WAY WE DEFINE EARLY STAGE INVESTIGATORS RATHER THAN DECREASING IT BECAUSE WHAT WE SEE IS THAT INSTITUTIONS AREN'T HIRING PEOPLE RIGHT AWAY AFTER THEIR -- AFTER THEY GET THEIR DEGREE. SO DEMOGRAPHICALLY WE DON'T SEE BIG DIFFERENCES BETWEEN THE ESAs DEFINED AS TEN YEARS WITHIN GETTING YOUR DEGREE. WE DON'T SEE A BIG DIFFERENCE BETWEEN THOSE TEN YEARS OUT AND THOSE 12 YEARS OUT. NOT CLEAR THAT MAKES A DIFFERENCE BUT WE WORRY IF WE WERE TO EXPAND THAT DEFINITION MIGHT THAT NOT PUSH THE AGE AT GETTING FIRST AWARD UP AND HOW DO WE TRY TO DEAL CONSTRUCTIVELY WITH UNINTENDED NEGATIVE CONSEQUENCES. LET ME FINISH YOU CAN COME BACK AND ASK ME MORE. BUT WE ARE FOCUSED ON PRY MAY REMEMBERLY P PH,s. NOT BECAUSE WE DON'T LIKE M.D., I'M AN M.D. BUT DEFINITION OF EARLY STAGE INVESTIGATORS THE DIFFERENT FOR M.D. EGGS AND FOR Ph.D.s, FOR M.D.s IT'S WHEN YOU -- YOU FINISH YOUR TRAINING AND THEN YOU HAVE TEN YEARS. WHEREAS FOR Ph.D.ES IT'S WHEN YOU GET YOUR DEGREE SO WE SEE THIS AS BEING A MUCH BIGGER ISSUE FOR Ph.D.s THAN FOR M.D.s ALTHOUGH WHEN IT COMES TO M.D.s DOING RESEARCH CLEARLY WE WOULD LIKE FOR THERE TO BE MORE M.D.s IN THE PIPELINE. BUT THIS IS THIS PARTICULAR INITIATIVE ISN'T THE PRINCIPLE WAY OF GETTING THERE. >> THANKS DR. LOWY, WE WANT YOU TO JOIN US FOR MORE DISCUSSION IF YOU HAVE TIME. >> SURE. >> JULIA. OUT THE DOOR. THANKS TO DR. LOWY AND SHELLEY FOR OUR IT'S A PRIVILEGE TO SERVE IN THIS OFFICE. I'M EXCITED, BOB HAS PRESSURE ON HIM TO FIND A SUCCESSOR THE REMARKABLE THING IS -- OVER TIME THAT'S POSSIBLE BECAUSE OF ENORMOUS SUPPORT THE OFFICE FROM ALL LEVELS AT THE NCI, WE HAVE UNBELIEVABLY SUPPORTED NCI DIRECTORS, ALL FIVE DIRECTORS IN THE OFFICE WAS CREATED, HAVE BEEN WONDERFUL CHAMPIONS FOR THIS WORK CLEARLY MY BOSS AND HIS PREDECESSOR BARBARA RIMER WHO HAS THE WISDOM WHEN SHE CREATED AFTER THE OFFICE IS CREATED, IT WAS CREATED IN 1996, THE DIVISION WAS CREATED IN 1997 AND BARBARA RIMER MADE IT A CRITERION BY MOVING THE OFFICE INTO THAT DIVISION WHICH IS WONDERFUL BECAUSE IT CREATED THE INFRASTRUCTURE TO BUILD SCIENCE. WE HAVE SEEN THAT OVER TIME, 1996 WE HAD NINE GRANTS SURVIVORSHIP GRANTS, MOST RECENT PORTFOLIO ANALYSIS FY 2016, WE HAVE 215 GRANTS THAT WE NARROWLY DEFINE THAT, SO STUDIES POST TREATMENT EXCLUDES ALL THE SCIENCE WE DO IN ACTIVE TREATMENT OR END OF LIFE RECURRENCE. SO WE HAVE TO THINK ABOUT THAT WHEN WE THINK PORTFOLIO. SO BECAUSE WE ARE TALKING TRAINING REFLECT TOO THAT GRANT PORTFOLIO, 41 GRANTS ARE TRAINING GRANTS BECAUSE WE HAVE ENORMOUS INTEREST IN TRAINING UP AND DOING RESEARCH AND SURVIVORSHIP AND DELIVERING THAT CARE SO THAT'S VERY EXCITING. THE ONLY FINAL COMMENT I'LL MAKE IS IT'S ONLY HERE BECAUSE HOE THAT OFFICE EXISTS BECAUSE OF X SURVIVORS CAREGIVERS, HEALTHCARE PROFESSIONALS, NOT ENOUGH TO CURE CANCER OR CONTROL CANCER WITHOUT THE COST OF DOING THAT ON INDIVIDUAL, ON SOCIETY. THAT IS VERY IMPORTANT IN OUR ABILITY TO DO THE WORK WE'RE DOING. I FEEL LUCKY I CAME TO THE RIGHT PLACE AT THE RIGHT TIME. I WOULDN'T HAVE BEEN ON THIS POSITION WITHOUT ELLEN STOVALL COMING AND SAYING YOU NEED TO APLAY FOR THIS JOB. WE GO TO THEN DIRECTOR NCI BEN KLOSNER WHEN YOU HIRE HER BECAUSE SHE HAS A SENSE OF HUMOR. THAT'S THE BARGAINING CHIP. SO MY ONLY SENSE OF HUMOR EXCHANGE WITH DR. PLOSNER I MET HIM, I WAS TERRIFIED, MEETING NCI DIRECTOR, I'M A LONELY RESEARCH COMING OUT OF ACADEMIA WE WERE HAVING A WONDERFUL CONVERSATION AND WHEN I REFLECTED BACK I SAID DR. POSNER WHEN YOU DISCOVER THE CURE FOR CANCER NEXT WEEK MY OFFICE STILL BE HERE BECAUSE EVERYBODY IS SURVIVORS. ANYWAY, AGAIN, IT'S BEEN A PLEASURE. I AM NOT WALKING AWAY FROM THE FIELD AS SOME OF YOU KNOW I'M GOING TO BE GOING AND DOING SOME WORK FROM THE INFER CITY HERE IN D.C. -- INNER CITY, AT THE SMITH SENT FOR HEALING ARTS SO MY HOPE IS TO TAKE ALL INCREDIBLE EVIDENCE AT NCI USING TO SUPPORT AND UNDERSTAND HOW BETTER CARE -- AND DELIVERING -- PRIVILEGE TO SERVE. THANK YOU. [APPLAUSE] >> I SURE OTHERS HAVE QUESTIONS FOR DR. LOWY. ONE CAME TO MY MIND, PUTTING IMPRESSIVE STATUS OF THE ADULT MATCH TRIAL IN TERMS OF STATISTICS WE WERE MENTIONING. I GUESS MY QUESTION WAS ALMOST LIKE WHAT IS THE BUSINESS STRATEGY GOING FORWARD, HIGH ENROLLMENT, NUMBER OF ASSAYS. THAT'S A LOT OF PRODUCTION SO WILL CERTAIN ASPECTS GO INTO REGISTRATION TRIALS. >> I THINK IT WILL DEPEND ON THE OWNER. ONE POSSIBILITY IS THAT A MANUFACTURER OF THE DRUG MIGHT SAY THIS IS INTERESTING ENOUGH FOR US TO WANT TO DO A TRIAL. SO THEY MIGHT TAKE OVER THE TRIAL, ALTERNATIVELY THEY MIGHT SUPPORT SUCH A TRIAL CONDUCTED UNDER OUR AUSPICES. IT WILL DEPEND ON THE PARTICULAR TREATMENT ARM. THERE ARE OPPORTUNITIES FOR IMMUNOTHERAPY. TO BE ADDED AS ALTERNATIVES FOR SOME ARMS FOR PEOPLE WHO ARE NOT RESPONDING, ET CETERA. SO IT'S NOT AS THOUGH WE'RE FINISHED, IF YOU WILL, THESE MULTI-ARM TRIALS. WHEN I THINK HAS MADE THE TRIAL SUCCESSFUL, IS FIRST EXTRAORDINARY PLANNING. ON THE PART OF THE PEOPLE FROM THE COOPERATIVE GROUPS AND NCI DIVISION OF CANCER TREATMENT. AND DIAGNOSIS. AND MAKING IT A TRULY NATIONAL TRIAL. THE SECOND THING IS, ENGAGEMENT OF THE PHARMACEUTICAL COMPANIES, BECAUSE THE PHARMACEUTICAL COMPANIES RECOGNIZE THAT IF THEY PROVIDED DRUG THAT WAS REALLY ALL THEY NEEDED TO DO. THEN THESE SMALL PERCENT PATIENTS WITH PARTICULAR KIND OF CANCER COULD BE INVESTIGATED AND FOUND IF THERE WAS A SIGNAL U FOR COMPANIES TO DO THIS INDIVIDUALLY WOULD HAVE BEEN PROHIBITIVELY EXPENSIVE. IF YOU JUST ASSUME THAT EVERY DRUG THERE'S ONE PERCENT CHANCE OF A PATIENT TO BE ADDING APPROPRIATE ABOUT NORMALITY. FOR EVERY DRUG THEN YOU NEED TO SCREEN A HUNDRED PEOPLE. WHAT WE SAW IS BY PUTTING THESE DRUGS TOGETHER YOU ONLY NEED TO SCREEN A LITTLE OVER SIX PEOPLE IN ORDER TO IDENTIFY AN ABNORMALITY THAT CAN -- A PATIENT CAN PUT ON FOR A TRIAL. IT IS REALLY I THINK THE BECOMING COST EFFECTIVE IN THIS WAY A PUBLIC PRIVATE PARTNERSHIP AND CLEARLY A MAJOR, MAJOR NEED BECAUSE WE WOULDN'T BE HERE IF WE ALL DIDN'T RECOGNIZE MANY TOO MANY PEOPLE DIED FROM THEIR CANCER. THIS IS A WAY TO TRY TO INTERVENE WHILE WE'RE PURSUING RESEARCH EARLIER POINTS WILL BE SUCCESSFUL IN THOSE APPROACHES. >> FOR THE 90% OF PEOPLE WHO DON'T HAVE A TARGETABLE MATCH ON THE PROFILING. HAVE YOU GIVEN ANY ADDITIONAL THOUGHT TO TRYING TO MATCH THEM TO OTHER CLINICAL TRIALS? THAT MAYBE -- >> I DON'T THINK THERE HAS BEEN A SYSTEMATIC EFFORT TO DO THAT. BUT IF THERE WERE OTHER TRIALS THEY WILL BE TOLD ABOUT THAT FROM THEIR -- BY YOUR PHYSICIAN. BUT I DON'T THINK WE'RE SPECIFICALLY YOU WOULD BE ELIGIBLE FOR THAT. >> YES, WE ANTICIPATE LIKE THE ADULT MATCH TRIAL I THINK STARTED WITH TEN AGENTS. WE'LL NOW END UP WITH 30. WE LOOK FORWARD TO THERE BEING MORE -- IT'S ONE THING TO GET A COMPANY TO COMMIT IN PRINCIPLE, SOMETHING ELSE TO HAVE THEM. >> THANKS, DR. LOWY, FOR YOUR PRESENTATION. WITH REGARDS TO THE QUESTION WITH ENCOURAGING AND SUPPORTING EMERGING INVESTIGATORS, AND PARTICULARLY IN BRINGING WOMEN AN ETHNIC MINORITIES INTO THE FIELD, I HAD THE PRIVILEGE AND OPPORTUNITY TO PARTICIPATE IN THE LOMBARDI TRAINING PROGRAM IN CANCER CARE RESEARCH. AT UCSF AND IT REALLY FOR SOMEONE IN MY CASE, WHO WASN'T AT THAT MOMENT REALLY INTERESTED IN GOING INTO CANCER RESEARCH, IT INSPIRED ME AND MADE ME INTERESTED IN THE FIELD, MY UNDERSTANDING IS THAT HISTORICALLY THERE'S CHALLENGES TO THAT PROGRAM BEING ABLE TO EXPAND, ITS EACH. I'M WONDERING IF YOU GOT SOME SENSE AROUND WHAT THE FUTURE LOOKS LIKE. I UNDERSTAND Y'ALL DON'T KNOW YET WHAT YOUR BUDGET LOOKS LIKE. BUT AT LEAST >> WHAT YOU'RE REALLY ASKING IS ARE UNDER-REPRESENTED MINORITIES, GOING TO BE A FACTOR GOING FORWARD. >> I LIKE THAT QUESTION. AND THE ANSWER IS WE HAVEN'T MADE FIRM DECISIONS YET BUT WE ARE -- THIS IS SOMETHING VERY SERIOUSLY CONSIDERING DOING. THE PROBLEM -- JUST THE ISSUE WE HAVE LET'S SAY YOU FUND UP TO 12 PERCENTILE OR WHATEVER WHATEVER IT IS, HOW MUCH HIGHER SHOULD WE GO TO TRY TO GIVE SPECIAL CONSIDERING FOR WOMEN UNDER-REPRESENTED MINORITIES, RESEARCH ON MINORITY HEALTH IN CANCER. THESE ARE ALL ISSUES THAT WE'RE THINKING ABOUT THE REAL ISSUE IS HOW MUCH DO WE -- HOW MUCH DO WE TRY TO PROVIDE AN ADVANTAGE TO THOSE PEOPLE? IF WE GIVE EVERYONE AN ADVANTAGE, NO ONE GETS AN ADVANTAGE. SO WE HAVE TO THINK ABOUT THAT, AND IF YOU HAVE THOUGHTS ABOUT THAT I WOULD BE DELIGHTED TO -- I >> I DO FROM A SOCIAL SCIENCES PERSPECTIVE, I THINK WELL DOCUMENTED THAT WOMEN AND PEOPLE OF COLOR HAVE HAD SIGNIFICANT DISADVANTAGES HISTORICALLY. AND I THINK THAT THE SETTING A GOAL OF HAVING CLINICAL TRIALS, COMMUNITY OF INVESTIGATORS WORKING IN THE FIELD BEING PROPORTIONALLY REFLECTIVE OF THE COUNTRY FOR ME SEEMS LIKE A LAUDABLE GOAL. AS LONG AS WE KNOW FAR FROM GETTING THERE, THERE'S STILL COLLECTIVELY MOTIVATION FOR CONTINUED INVESTMENT UNTIL WE GET IT. >> MAY I SAY SOMETHING IN >> GO I A HEAD, JUNE. >> THANK YOU. FOR ME IT'S -- I APPRECIATE WHAT HE SAYS ABOUT LOOKING AT WHEN YOUR CUT OFF IS FROM EARLY INVESTIGATOR ONWARD. I DO UNDERSTAND THAT THIS MORE SO PARTICULAR Ph.D., I THINK THAT CONSIDERING THAT UNDER-REPRESENTED MINORITIES IN PARTICULAR TEND TO ACCESS THE SYSTEM OFTEN LATER COME THROUGH NON-TRADITIONAL ROOT. I LIKE THE SCIENCE, THEY'RE PURE, (INDISCERNIBLE) THAT BEING SAID I THINK THE IDEA OF MAYBE LOOKING AT PEOPLE TRAJECTORY IN TERMS OF THE FIRST GRANT, SO FORTH EXTENDING THAT FROM THE -- AND WE WANT TO KEEP THE FIELD FAIR, FAIRNESS IS WHAT I WANT. BUT FOR ME PERSONALLY AS AN UNDER-REPRESENTED MINORITY, I WANT THE SCIENCE TO STAND ON ITS OWN, BLINDED TO YOUR RACE. YES WRITE THE GRANT. I WOULD JUST LIKE SOME CONSIDERATION FOR Ph.D.s FOR WHEN YOU GET TO THE NEXT STAGE. BECAUSE IT OFTEN TAKES A LONGER TIME FOR URL TO -- RN A NEW RN TO GET TO THAT STAGE. >> JUNE, THANKS VERY MUCH. IT'S NOT JUST UNDER-REPRESENTED MINORITIES BUT THERE ARE A NUMBER OF TRAINING WE SUPPORT WHICH TAKE A LONG TIME. OTHER TRAINING COMPONENTS. SO WE'RE SERIOUSLY THINKING ABOUT HOW DO WE RECONCILE ALL OF THIS SO THAT WE CAN BE FAIR AS POSSIBLE TO APPLICANTS BUT AS I SAID, IN SOME WAYS WE CAN SIMPLY -- WE CAN SIMPLY ELIMINATE THOSE CRITERIA. EARLY STAGE INVESTIGATORS TO BEAT ANYBODY WHO HAD NEVER HAD A MAJOR NIH GRANT. AND THEN THERE WOULD BE NO TIME LINE, BUT WE WORRY THAT THAT MIGHT CREATE ITS OWN PROBLEMS. SO WHERE IS THE RIGHT BALANCE AND PART OF THE REASON WE'RE TRYING TO EXAMINE THIS CAREFULLY IS THAT WE DON'T YET KNOW EXACTLY WHERE THE RIGHT PLACE TO COME OUT IS BUT I'M TRYING TO GET A SENSE OF THE EXTREMES. >> THIS IS REGINA. ONE OF THE QUESTIONS I HAVE IS WHETHER NCI AND NIH HAVE CONSIDERED A BLINDED LETTER OF INTENT PROCESS. BECAUSE THE BLINDING OBVIOUSLY ALLOWED IT TO BE TRULY AS JUNE SAID BASED ON THE BEST SCIENCE AND THEN THE INVITEES ARE UNBLINDED TO THE STUDY SECTION ULTIMATELY BECAUSE ONE HAS TO JUDGE PROPENSITY OF THE CANDIDATE. I'M WONDERING IF THAT'S SOMETHING THAT'S BEEN CONSIDERED, AS A WAY TO BUILD ACROSS. >> THAT HAS BEEN CONSIDERED FOR A PILOT STUDIES AND THINGS LIKE THAT. BUT NOT NIH WIDE. >> (INAUDIBLE) BACK UP ON WHAT YOU SAID. >> PLEASE GO AHEAD. >> I HAVE BEEN AT STUDY SECTIONS WHERE I'M TELLING YOU WE HAVE (INDISCERNIBLE) PROPOSAL AND THIS WORK THEY'RE -- BUT SOMEONE WILL SAY WE KNOW THEY CAN DO IT. SO ALWAYS THE PERSON HAS THESE WONDERFUL GRANTS IS THAT PERSON WHO (INAUDIBLE) AT THIS PARTICULAR CITY OR ACTUALLY END UP BEING GIVEN THE BENEFIT. DOUBT AND THE EARLY INVESTIGATOR WHO DOES NOT ALL THAT MONEY AND THAT BIG LAB DOESN'T GET THE OPPORTUNITY. I THINK YES IT'S GOOD TO KNOW PEOPLE'S TRACK RECORD BUT SOMETIMES I THINK IT'S OVERLY BENEFICIAL TO THAT PERSON. WHO HAS RECOGNITION. SOMEONE GETTING ON THE PATHWAY WHERE THE SCIENCE TRULY IS WORTH ITS MEASURE AT EVERY SINGLE TIME WE SIT AND DISCUSS THESE KINDS OF PROPOSALS. I APPRECIATE WHAT REGINA SAID BECAUSE (INAUDIBLE). >> LET ME SAY WHEN IT COMES THE NEW APPLICATIONS, WE FUND ESSENTIALLY THE SAME RATE AS EARLY STAGE INVESTIGATORS AS FOR EXPERIENCED INVESTIGATORS. THE SUCCESS RATES ARE NOT HIGHER FOR THE EXPERIENCE INVESTIGATORS THAN THEY ARE FOR THE EARLY STAGE INVESTIGATORS. WHAT WE ARE ACTUALLY THINKING ABOUT NOW IS HAVING A BIGGER BOOST FOR EARLY STAGE INVESTIGATORS SO THEIR SUCCESS RATES WOULD BE HIGHER THAN THAT OF EXPERIENCED INVESTIGATORS WHO ARE MAKING A NEW PROPOSAL. WHEN IT COMES TO RENEWALS OF PROPOSALS THAT WE HAVE FUNDED PREVIOUSLY BY DEFINITION THOSE ARE COMING IN FROM EXPERIENCED INVESTIGATORS. THEY ACTUALLY -- THEY DO, DO BETTER THE NEW PROPOSALS OF BRAND NEW PROPOSALS. I WOULD ALSO POINT OUT HOWEVER THAT THE NCI FUND A SUBSTANTIALLY SMALLER PERCENTAGE OF RENEWALS OVERALL THAN NIH-WIDE. NIH WIDE THREE PROPOSALS THREE AWARDS IN TEN. ARE FROM RENEWALS, NCI IS TWO IN TEN SO 80% OF ALL OUR MAJOR AWARDS ARE NEW AWARDS. NIH WIDE IT'S ABOUT 70. >> THANK YOU. >> THANKS, JUNE. >> THANK YOU. >> AT THIS TIME WE'LL DO A SHORT PRESENTATION WITH SOME FINDINGS THAT WE CAME UP WITH YOU, DR. LOWY. >> THIS WAS AN N OF ONE STUDY IT WASN'T COMMISSIONED BY THE NIH BUT WE TOOK IT UPON OURSELVES TO REFLECT IN A SHORT RESEARCH STUDY, DIDN'T TAKE LONG, DIDN'T HAVE TO BE LONGITUDINAL BECAUSE IT'S SO OBVIOUS. UNDER DR. LOWY'S LEADERSHIP OUR COUNTRY HAS REALLY MADE A HECK OF A LOT OF PROGRESS. THINK ABOUT ALL THAT'S GONE ON AND REALLY TWO AND A HALF YEARS UNDER DR.S LOWY'S LEADERSHIP, IT'S BEEN AMAZING THE PROGRESS. AND IT'S NOT JUST AS A RESULT OF HIM, IT'S BEEN THROUGH HIM. HE'S A FACILITATIVE LEADER. SO LET'S TAKE A LOOK. THE LAST PRESIDENT WHO GOD PRECISION MEDICINE INITIATIVE GOT REALLY GOING, AND THERE'S THE CANCER PRECISION MEDICINE, AND DR. LOWY LEADERSHIP THAT TOOK OFF AND WE HEARD ABOUT BOTH MATCH TRIALS TODAY AND THE SUCCESS OF THIS EARLY LAUNCH OF THEM. JUST IMAGINE HOW MANY ASSAYS, THAT ASSAY NUMBER IS ASTOUNDING. ALL THOSE THINGS CAN BE HUGE, HUGE WINS. INCREDIBLE. THE CHILDHOOD CANCER COMMUNITY, WE ARE TICKLED PINK THAT THE PEDIATRIC MATCH TRIAL IS FINALLY UNDERWAY AND IS MOVING FORWARD. THE CANCER MOON SHOT LEADERSHIP ORGANIZATION THE INVOLVEMENT OF KEY NCI LEADERS LIKE DINA SINGER THE COLLABORATIVE LEADERSHIP AND NOW THE MOON SHOT RECOMMENDATIONS ARE BEING FUNDED INTRAMURALLY EXTRAMURALRY AND THE BEST IS YET TO COME. EXCITED ABOUT THE NEXT TWO YEARS WHERE THAT IS GOING, BIG EXPECTATIONS OF THAT. BUT ALSO THE WAY IT WAS DONE, MANY OF US AROUND THE ROOM PARTICIPATED IN ONE WAY OR ANOTHER IN THE CANCER MOON SHOT PROCESS ON THE WORKING GROUPS OVER 150 PEOPLE WERE INVOLVED IN THOSE WORKING GROUPS OVERALL, DRAWING UPON THE RESEARCH AND EXPERIENCE AND LIFE EXPERIENCE OF HUNDREDS MORE THE ONLINE ACTIVITY SOLICITATION PUBLIC COMMENT, ALL THAT WAS REALLY A GREAT EXAMPLE OF OPEN GOVERNMENT AT ITS BEST UNDER THE LOWY ADMINISTRATION OF NCI. WE HEARD A LOT ABOUT BIG DATA IN LAST FEW YEARS, ESPECIALLY WITH VICE PRESIDENT BIDEN HAMMERING US SAYING WE GOT TO GET TOGETHER ON BIG DATA AND THE NCI REALLY DID IT. DR. LOWY'S LEADERSHIP WITH LAUREN KIBBE AND SO MANY OTHERS LAUNCHED THE DATA COMMONS WHICH NOW FOUNDATION MEDICINE AND OTHERS ARE PUTTING MORE DATA INTO THAT. AND BRINGING THAT TO LIGHT. HEALTH DISPARITY, SOMETHING WE TALKED QUITE A BIT IN THIS ROOM, SUCH A NOT JUST INITIATIVE OR SILOED THING BUT SOMETHING THAT SHOULD BE IN EVERY POCKET, EVERY CORNER EVERY PIECE OF OUR THOUGHT PROCESS TO MOVE CANCER RESEARCH ALONG BUT A COUPLE OF MAJOR INITIATIVES GOT STARTED UNDER DR. LOWY WITH BREAST CANCER GENETICS PROJECT AND GROUND BREAKING STUDY IN AFRICAN AMERICAN CANCER SURVIVOR, MAJOR THINGS GOING ON AND DR. LOWY VISITED OKLAHOMA WHERE HE HAD RICH DIALOGUE WITH NATIVE AMERICAN TRIBES THERE. BIG INCREASE IN NCI IMMUNOTHERAPY. AGAIN, NOT ALL OF IT DR. LOWY DOING BUT LEADING THE TEAM TO DO IT. AND POSITION NCI TO BE LEADER SHIP FOR US AND MAKING PROGRESS IN IMMUNOTHERAPY. AS WELL AS EXPLAINING TO THE AMERICAN PUBLIC, WHAT IS IMMUNOTHERAPY, I' NOT ALL CAR T. HOPE ANY WE KNOW THAT NOW. CONTINUED COMMITMENT TO EARLY INVESTIGATORS. WE HAD A RICH DISCUSSION ABOUT THAT. WITH THIS ADMINISTRATION, THE LOWY ADMINISTRATION IS FOCUSED ON EARLY CAREER INVESTIGATORS, HELPING YOUNG PEOPLE GET STARTED IN THESE CAREER AND KEEP GOING. IMPROVING LIVES THROUGH CANCER RESEARCH. I HOPE ALL OF YOU SAW THE HUGE NEWS OF DR. LOWY, DR. SCHILLER'S HONOR IN THE LAST WEEK OR TWO FOR THE MARY LASKER AWARD FOR DEVELOPMENT OF HPV VACCINES. Y'ALL KNOW WHO MARY LASKER IS, ONE OF THE ORIGINAL CANCER ADVOCATES, FOUNDED THE WAR ON CANCER, WORKED WITH SIDNEY FARBER, THIS IS JUST A HUGE, HUGE HONOR. THIS IS THE TOP AMERICAN AWARD IN CANCER RESEARCH THERE IS. AND 82 WINNER AT THE LASKER PRIZE HAVE GONE ON TO WIN THE NOBEL PRIZE. SO SIT OOHs A BIG DEAL AND SO IT'S A REALLY BIG DEAL AND GENERATIONS OF PARENTS WILL THANK DR. LOWY AND DR. SCHILLER FOR THEIR WORK WHICH IS PROTECTING SO MANY KIDS TODAY. HUGE SET OF ACCOMPLISHMENTS. DR. LOWY'S BEEN AT THE NCI A GREAT NUMBER OF YEARS, WE HOPE HE'S HERE A GREAT NUMBER OF MORE YEARS. >> YOU CAN'T COUNT THAT HIGH. >> I REALLY CAN'T COUNT. BUT HOPE HE'S HERE A LONGER PERIOD OF TIME CONTINUING TO LEAD IN EVERY CAPACITY MAKING A HUGE DIFFERENCE AND JUST HUGE THANKS ON BEOF OF ADVOCATES TO DR. LOWY FOR THIS EXPERIENCE. THE DOOR HAS BEEN OPEN TO ADVOCATES SINCE DR. LOWY BECAME ACTING DIRECTOR. HE'S LISTENED TO US HEARD WHAT WE HAVE TO SAY, DOOR IS ALWAYS OPEN, GREAT LISTENING EAR. VERY MUCH AT LEAST I THINK THE PATIENTS NCI DIRECTOR. IN EVERY RESPECT. SO THANK YOU, DR. LOWY. [APPLAUSE] >> THANK YOU, DR. LOWY. >> THANK YOU ALL. I THINK JULIA SAID IT BEST. IT IS A PRIVILEGE TO SERVE. >> JUST WANT TO ECHO FOR THE CHILDHOOD CANCER COMMUNITY. I WANT TO SAY YOU TALK WITH US, NOT AT US. THAT IS A HUGE CHANGE OVER THE YEARS AND COMES TO THE TAME IN A WAY NO OTHER DIRECTOR HAS. WE HAVE SEEN THE COMMITMENT ON BEHALF OF NCI AND BRINGING CHANGE AND WE ARE ETERNALLY GRATEFUL. >> LAWRENCE LIVERMORE ONE OF THE PROGRAMS THAT WE WERE HELPING TO STAND UP IS TRYING TO SHORTEN THE TIME LINE FOR GOING FROM IDENTIFYING TARGET TO IDENTIFYING DRUG. THIS COLLABORATION INVOLVES PHARMACEUTICAL INDUSTRY. AS WELL AS LAWRENCE LIVERMORE. BUT I THINK SOME -- THEY WANTED TO BE PRECOMPETITIVE BUT I THINK THAT TRYING TO DEVELOP INHIBITORS FOR TARGETS AGAINST PEDIATRIC CANCER IS IN SOME WAYS A RIGHT THING TO DO BECAUSE YOU ARE NOT STEPPING ON THE TOES OF THE PHARMACEUTICAL INDUSTRY IF YOU WANT TO GO THAT DIRECTION. AFTER I MEET THIS AFTERNOON I'M MEETING WITH THE NCI PERSON COORDINATING THAT PROGRAM. >> I THINK WE SHOULD ECHO TALKING WITH US, NOT AT US. SO WE CAN WELCOME CHANGE AND APPRECIATE YOU ARE SO HOPE TO HEARING FROM US AS ADVOCATES. AND WHAT DAVID SAID ABOUT GENERATIONS OF PARENTS THANKING BUT WHEN I TOOK MY SON TO GET HIS HPV SHOT, IT HURTS MORE THAN OTHER SHOTS. SO HE WASN'T HAPPY ABOUT GOING BACK FOR THE SECOND AND THIRD. AND HE KNOWS I WORK IN CANCER AND THEY WORRY ABOUT CANCER AND WHAT WE CAN DO. I SAID THERE'S NOT A LOT YOU CAN DO TO PREVENT CANCER BUT THIS IS ONE OF THEM. I HAPPEN TO GET TO HEAR FROM THE MAN WHO IS RESPONSIBLE FOR THIS. AND I SAID THIS IS SOMETHING YOU CAN DO. HE HAD TO BE HELD DOWN BY A NURSE TO DO IT. I'M SO GRATEFUL AND MY UNCLE HAS BATTINGED HPV RELATED HEAD AND NECK CANCER. SO I CAN SAY WHAT UNCLE PAUL IS GOING THROUGH YOU MIGHT NOT HAVE TO GO THROUGH BECAUSE OF THIS. THANK YOU. >> SO I WANTED TO -- BECAUSE I'M A PEDIATRIC FOCUSED INDIVIDUAL I GO WITH WHAT DANIELLE SAID, IT'S EVIDENCE IN THE IMMUNITY HOW YOU'RE VIEWED. THAT'S A TESTAMENT TO THE WAY THAT YOU HAVE ADVOCATED FOR KIDS. I ALSO WANTED TO SAY SOMETHING ABOUT YOUR SUPPORT FOR SURVIVORSHIP. I HEARD YOU SPEAK IN MANY VENUE, A THAT'S A PROMINENT PART OF WHAT YOU TALKED ABOUT WHICH TO ME PERSONALLY AS A SURVIVOR I APPRECIATE THAT AND CARRIED FORE AND WE KEEP DOING IT. THANK YOU FOR LEADERSHIP. >> I ALSO WANT TO ASSAY A HUGE THANK YOU, IT'S BEEN A TREMENDOUS CHANGE IN BRINGING US TO THE TABLE AND FEELING LIKE WE HAVE A VOICE. AND WE CAN HAVE A VOICE AND SAY -- BE EMPOWERED TO HAVE ENTHUSIASM AND ENERGY AND SPIRIT AND THAT BE OKAY SO I APPRECIATE THAT. I'M ALSO VERY APPRECIATIVE THAT YOU HAVE BEEN SO OPEN TO PUBLIC PRIVATE PARTNERSHIPS. AND THAT THAT'S A REAL CHANGE FOR THE INSTITUTE. AND YOUR LEADERSHIP IS ALLOWING FOR THAT SO THANK YOU. >> THANKS, EVERYBODY, IT'S BEEN A GREAT DAY. DR. LOWY, THANK YOU FOR BEING WITH US. >> VERY GLAD THAT I DON'T NEED TO WEAR A HAT WHEN I GO OUTSIDE. BECAUSE IT WOULDN'T FIT ME. >> YES, I WOULD LIKE TO THANK DAVID FOR LEADING TODAY'S MEETING AND HELPING US PLAN A LOT OF WORK GOES INTO THESE IN ADVANCE AND A LOT OF WORK HAPPENS HERE AT THE TABLE AND I APPRECIATE BRINGING US TOGETHER AND KEEP OUR BRAINS WORKING AND MOVING FORWARD. I WANT TO THANK YOU FOR YOUR TIME AND YOUR THOUGHTS TODAY, WE COVERED A LOT OF STUFF, EVERYBODY SHOWED UP AND THAT IS TO THE BENEFIT OF PATIENTS ACROSS THE COUNTRY SO THANK YOU ALL. THANK YOU, DOUG, FOR JOINING US TODAY AND TO OUR SPEAKERS FROM THIS MORNING, IT REALLY IS A GROUP EFFORT AND THERE'S A LOT OF ENTHUSIASM AND SPIRIT, THIS IS THE PLACE FOR IT. SO WE LOOK FORWARD TO CONTINUE WORKING WITH YOU IN THE DAYS TO COME. MOST OF YOU STAFF FROM THE ADVOCACY OFFICE SITTING ALONG THE EDGES. I WANT TO THANK THEM FOR THE WORK THEY DO. WITH NCRA AND ADVOCATES ACROSS THE COUNTRY SO IF YOU HAVEN'T MET ALL OF THEM, I HOPE YOU CAN SPEAK TO EACH OTHER AS WE'RE HEADING OUT TODAY. THEY DO TREMENDOUS WORK ON BEHALF OF THE PATIENTS AS WELL. THANK YOU. I THINK WE'RE ADJOURNED. NOT SURE IF I SAY THAT OR YOU DO. >> JUNE AND REGINA, THEY CAN FOR HANGING IN THERE TODAY. >> YOU'RE WELCOME. THANK YOU SO MUCH FOR RUNNING THIS SO WELL. >> QUICKLY, I ALSO WANTED TO THANK YOU, DR. LOWY, I HAVEN'T HAD THE BENEFIT OF BEING ABLE TO COMPARE YOU TO OTHER DIRECTORS. BUT I APPRECIATE THE SENSE THAT -- I APPRECIATE THE SENSE YOU'RE ACCESSIBLE TO US AND YOU HAVE ALWAYS BEEN HERE. AND OPEN TO HEAR FROM US. SO THANK YOU SO MUCH. GLAD YOU'RE STILL AROUND. >> GLAD TO BE AROUND. >> MUCH SMALLER LEVEL. THOSE IN NEED OF TAXIS ARE ON THE WAY SO WE CAN SHEPHERD YOU RIGHT OUT FRONT. CLOSE TO WHERE YOU WERE DROPPED