WE HAVE FOUR PEOPLE ON THE PHONE, FIVE NOW. THE FOUR PEOPLE ON THE PHONE ARE FOLEY, EMMONS, SMITH, VERDINE AND WHO IS FIFTH PERSON? >> DREBIN. >> AND DREBIN. WE HAVE FIVE PEOPLE OP THE LINE. THOSE OF YOU THAT ARE ON THE LINE, ON THE PHONE, PLEASE INDICATE WHO YOU ARE BEFORE YOU SPEAK, BEFORE YOU ASK A QUESTION. I WILL NOW SEND IT OVER TO TODD TO TAKE IT FROM THERE. TODD, WE DO HAVE A QUORUM. >> THANK YOU, PAULETTE. VERY EXCITING, FIRST EVER VIRTUAL MEETING OF THE BOARD OF SCIENTIFIC ADVISORS. FOR THOSE WHO THOUGHT YOU YOU COULD ESCAPE THE RITUAL READING OF THE GOSPEL ACCORDING TO PAULETTE, YOU'RE MISTAKEN. AM YOU STILL HAVE TO SUFFER THROUGH MY READING OF THE OBLIGATORY PARAGRAPH. >> PUT YOUR MUTE ON AND READ IT. >> DR. PAULET GRAY, SECRETARY OF THE BOARD. WRITTEN STATEMENTS WILL RECEIVE CAREFUL CONSIDERATION. BOARD MEMBERS, I WANT TO REMIND YOU, SPECIFIC MATTER CREATING THE APPEARANCE OF ONE. ADVISE THE EXECUTIVE SECRETRY THE CURRENT POLICIES GOVERNING FINANCIAL HOLDINGS OF SPECIAL GOVERNMENT EMPLOYEES WHICH CATEGORY INCLUDES -- WE MUST DEPEND ON YOU TO ABSENT YOURSELF IN DISCUSSIONS OF MATTERS THAT COULD IMPACT THE STATUS. WE TRUST YOUR JUDGMENT IN THESE INSTANCES. DURING ANY CLOSED SESSION, NOT PLANNED TODAY, ANY MATERIALS OR DISCUSSION OF A CONFIDENTIAL NATURE, DELIBERATED TODAY ARE PRIVILEGED INFORMATION AND ARE MADE AVAILABLE ON A NEED TO KNOW BASIS, SUCH DELIBERATIONS ARE PRIVATE AND CONTENTS SHOULD NOT BE DIVULGED. WE HAVE A QUORUM. AS PAULETTE SAID, MUTE YOUR VOICE, IF YOU'RE NOT SPEAKING. REMEMBER TO UNMUTE YOURSELF IF YOU WANT TO MAKE A COMMENT, IF YOU WANT TO ASK A QUESTION OR MAKE A COMMENT, YOU CAN GESTICULATE OR WE'LL FIGURE OUT HOW DO THIS AS WE GO ALONG. I THINK THAT'S IT. WE'LL START WITH HAROLD. >> OKAY, TODD. THANK YOU VERY MUCH. PAULETTE ASKED ME TO POINT OUT ONE OF YOUR MEMBERS, BRIAN DRUKER IS IN THE ROOM AND WE HAVE A QUORUM. I WANT TO DRAW YOUR ATTENTION TO THINGS THAT HAVE HAPPENED AT THE NCI OVER THE LAST FEW MONTHS. OBVIOUSLY, A MUCH MORE DETAILED UPDATE WILL BE AVAILABLE WHEN WE HAVE OUR JOINT MEETING WITH D I WOULD DRAW YOUR ATTENTION THE NCAB IN JUNE. TO THE FACT THAT YOU CAN SEE ALL OR PART OF LAST WEEK'S NCAB MEETING ONLINE, IT WILL BE ARCHIVED SHORTLY. AND THERE ARE MORE EXTENSIVE REMARKS FROM ME OF AN IMPORTANT PRESENTATION FROM BARBARA RHYMER, HEAD OF THE PRESIDENT'S CANCER PANEL, AND AN INFORMATIVE SILL POS SILL SYMPOSIUM ON TOBACCO, TO THE SURGEON GENERAL'S REPORT AND VERSIONS,ES AND NEW GLOBAL CONTROLLED TOBACCO, LOTS OF INTERESTING STUFF. I URGE YOU TO HAVE A LOOK AT THAT. A FEW COMMENTS ABOUT PERSONNEL YOU'LL BE INTERESTED IN, FIRST OF ALL, WE'RE SUSTAINING A TREMENDOUS LOSS WITH THE DEPARTIEURE OF THE EXECUTIVE OFFICE TO A POSITION AT A LESSER INSTITUTION IN CAME CAMBRIDGE, ACTUALLY BOSS ONAT THE ALREADY SRAR HARVARD MEDICAL SCENE, S CHOOL, IN CHARGE OF RESEARCH ACTIVITIES AND CHANGES IN THE COMMUNICATION STAFF. LANORE JOHNSON HAS MOVED TO ANOTHER INSTITUTE AND PETER GARRETT IS TAKING OVER HER POSITION AT THE OCE. AND IN ADDITION,s I'VE BEEN ABLE TO RECRUIT ON A PART-TIME BASIS ANN THOMAS, MANY OF YOU KNOW WAS THE DIRECTOR OF NIH COMMUNICATIONS, AND WORKED WITH ME AT THE MEMORIAL SLOAN KETTERING FOR SOME YEARS TO HANDLE MUCH OF MY PRESS RELATIONSHIPS. SOME OF YOU MAY BE CONFUSED BY ALL OF THE INFORMATION AND LACK OF INFORMATION ABOUT BUDGET FOR 2014 AND 15. LET ME RECAP VERY BRIEFLY WHAT IS CURRENTLY IN PLAY. AN APPROPRIATION BILL THAT TAKES US OUT TO THE END OF FY 14, THE END OF SEPTEMBER OF 2014, WAS PASSED JUST BEFORE THE DEADLINE OF JANUARY 15. YOU CAN -- THIS IS A CLASSICAL GLASS HALF EMPTY, GLASS HALF FILLED. IT RESTORED A LITTLE MORE THAN HALF OF THE MONEY THAT WAS TAKEN AWAY BY SEQUESTRATION, SO ON THE GOOD NEWS, NIH GOT A BILLION DOLLARS BACK. THE BAD NEWS IS THAT ALMOST TWO BILLION HAD BEEN TAKEN AWAY AND WE DON'T HAVE ALL THAT BACK. WE'RE ABOUT HALFWAY BACK TO 2012 LEVELS, ALL OF YOU PROBABLY REMEMBER 2012 WAS A FLAT YEAR, AFTER A YEAR IN WHICH WE HAD LOST 1% OF OUR BUDGET, SO OVERALL WE'RE STILL DOWN ABOUT 3% IN REAL DOLLARS, NOT CONSTANT DOLLARS, IN REAL DOLLARS COMPARED TO 2010, THE YEAR THAT I WAS FIRST HERE. AND THAT IS ON THE WHOLE A LAMENTABLE DECLINE. ON THE OTHER HAND, ONE CAN ARGUE WE'VE TURNED A CORNER, WE HIT BOTTOM IN 2013 AND WE'RE HALFWAY BACK IN 14. THE OPERATING PLAN APPROVAL WILL BE RELEASED SOON, BUT I HINK ALL OF YOU PROBABLY HAVE SOME IDEA MORE OR LESS HOW THESE INCREASES WILL BE DISTRIBUTED, WE CAN TALK MORE ABOUT THAT IF YOU HAVE SOME QUESTIONS. THIS WEEK, THE PRESIDENT ANNOUNCED HIS BUDGET FOR 2015, THE PROPOSAL THAT GOES TO CONGRESS. THERE IS NOT MUCH IN THAT BUDGET THAT IS SURPRISING, OR SUBJECT FOR APPLAUSE, BECAUSE WE'RE UNDERRING UNDER SEVERE CONSTRAINTS, THE DEPARTMENT ACTUALLY IS TAKING A BIT OF A CUT. NIH HAS A VERY SLIGHT INCREASE, THAT INCREASE IS MORE FOR THE NIH OVERALL AND PERCENTAGE TERMS THAN FOR THE NCI BECAUSE THERE ARE CERTAIN PROGRAMATIC ASSIGNMENTS, EARMARKS IF YOU WILL, FOR THE BRAIN INITIATIVE, FOR DIABETES, FOR ALZHEIMER'S RESEARCH THAT MEANS THAT NIH OVERALL HAS A SLIGHTLY HIGHER NUMBER THAN NCI. THE NCI INCREASE OVER FY 2014 IS NOT -- I STILL DON'T HAVE A PRECISE CA CALCULATION BUT 10 TO 20 BILLION AREA. THE MONEY IS APPRECIATED. I'M GLAD WE DIDN'T TAKE FURTHER CUTS, AND ATTENTION THE PRESIDENT'S PROPOSAL, WHICH IF YOU'RE FOLLOWING THE NEWS YOU KNOW IS A REQUEST FROM THE PRESIDENT WHICH CONGRESS MAY WELL NOT HONOR, IN MANY RESPECTS, BECAUSE THERE ARE TAX CHANGES BUILT INTO IT AND SOME FOLKS THINK THAT NONE OF THOSE TAX MEASURES WILL EVER GET PASSED, AND I THINK WE ALL WILL SIMPLY NEED TO WORK AS HARD AS WE CAN CAN CONGRESS TO BE SURE THAT THE PRESIDENT'S ASPIRATION FOR NIH ARE NOT ONLY MET BUT POSSIBLY EVEN EXCEEDED. I'M PROBABLY NOT SUPPOSED TO SAY THAT BUT I THINK THAT'S WHAT ALL OF US WOULD LIKE TO SEE HAPPEN. SO I ALSO DRAW YOUR ATTENTION IN YOUR ROLE AS ADVISORS TO THE NCI TO THE DEPARTURES OF MANY PEOPLE IN CONGRESS IMPORTANT TO THE NIH AND NCI, WITHOUT GOING INTO DETELL HEARKEN, KINGSTON, HOLD, WAX MAN AND DINGEL, ALL WHO PLAYED IMPORTANT ROLES IN THE LEGISLATION THAT AFFECTS SCIENCE, WILL BE DEPARTING AT THE END OF THIS YEAR. LET ME MENTION A COUPLE OTHER THINGS BEFORE WE TURN IT OVER TO THE MAIN ACTIVITY, THE CONSIDERATION OF A NUMBER OF RFA'S. TO NOTE A FEW THINGS OF INTEREST TO YOU, FIRST WE'VE HAD SOME DISCUSSIONS ABOUT NEW TYPES OF AWARDS, AND IN PARTICULAR DISCUSSION ABOUT OUTSTANDING INVESTIGATORS AWARDS THAT WE WOULD LIKE TO SEE INSTITUTED AS A SEVEN-YEAR AWARD. THIS HAS BEEN FAVORABLY RECEIVED NOT ONLY BY MY ADVISORY GROUPS AND BY THE OTHER INSTITUTE DIRECTORS AT THE ANNUAL INSTITUTE DIRECTORS RETREAT IN JANUARY. WE ARE PREPARED TO ANNOUNCE THIS NEW PROGRAM BUT WE'RE STILL HAVING DISCUSSIONS, DIFFIC DISCUSSIONS I HAVE TO SAY, WITH THE DEPARTMENT ABOUT MAKING THIS A SEVEN-YEAR AWARD RATHER THAN A FIVE-YEAR AWARD, MORE ON THAT SOON I HOPE. A NUMBER EVE OF OTHER THINGS ABOUT OUR GRANT-MAKING CAPACITIES, AND GRANT REVIEWING ACTIVITIES, YOU'VE ALL HAD SOME EXPOSURE TO OUR EFFORTS TO CHANGE THE NIH BIOSKETCH TO EMPHASIZE CONTRIBUTIONS TO SCIENCE, RATHER THAN A LIST OF PAPERS BEEN FAVORABLY RECEIVED BY THE INSTITUTE DIRECTORS AND WE WILL SEE SHORTLY SOME ACTION NIH-WIDE, I HOPE, AND IN GENERAL THE NIH INSTITUTE DIRECTORS HAVE BEEN VERY FAVORABLY DISPOSED TO SOME NEW IDEAS ABOUT AWARDS THAT WOULD EMPHASIZE CAREER DEVELOPMENT, ESPECIALLY EARLY STAGES OF CAREERS, I THINK WE'LL ALL SEE PROPOSALS OVER THEIES OVER THE NEXT YEAR OR TWO, THAT MIGHT BE A TOPIC WORTH BRINGING BEFORE YOU AND NCAB IN FORTHCOMING MEETINGS. YOU MAY BE READING ABOUT THE FACT THAT NIH-WIDE ALL INTRAMURAL PROGRAMS ARE BEING EVALUATED BY BLUE RIBBON PANEL THE. NINCI IS CERTAINLY AMONG THEM. OUR INTENTION IS TO TRY TO MAKE THIS AN EXERCISE IN WHICH WE IDENTIFY SOME WAYS IN WHICH OUR INTRAMURAL PROGRAM CAN BE IMPROVED, I'M CONCERNED ABOUT FUNDING OF THE CLINICAL CENTER, AND HOPEFULLY THERE WILL BE SOME RECOMMENDATIONS EMERGING FROM THIS REVIEW THAT WILL HELP US WITH RESPECT TO THAT DIFFICULTY. AND I'M HOPING THERE WILL BE SOME IDENTIFICATION OF EXCITING NEW PROJECTS THAT MIGHT BE MOST URAL PROGRAM. APPROPRIATERY CONDUCTED IN THE IN THAT VEIN, WE COULD DO SOMETHING ANALAGOUS THANKS TO THE LEADERSHIP OF GRO JOE GRAY, IN OUR CHAIRING OUR ADVISORY COMMITTEE FOR THE FREDERICK NATIONAL LABORATORY FOR CANCER RESEARCH, JOE RAN HIS FIRST MEETING RECENTLY AND WE HAD I THOUGHT A VERY FRUITFUL DISCUSSION OF A NUMBER OF PROPOSALS FOR PROJECTS THAT MIGHT BE SIMILAR IN MODE OF CONDUCT BUT DIFFERENT IN TOPIC FROM THE CURRENTLY -- RECENTLY INITIATED PROJECT TO TRY TO FIND BETTER WAYS TO KILL CELLS DRIVEN BY RASS MUTATIONS, MAKING THE NATIONAL LAB A VENUE FOR TAKING ON AMBITIOUS PROJECTS THAT WE THINK WILL HAVE GREAT PAY OR AND BENEFIT FROMMING AGGREGATED RESOURCES AT FREDERICK, A MODEL FOR WHAT THE INTRAMURAL PROGRAM MIGHT DO. PROGRESS MADE IN DEVELOPING CLINICAL TRIALS DEPENDENT ON GENOMIC INFORMATION, AND THESE INCLUDE THE MATCH PROGRAM, AN EFFORT TO UNDERSTAND EXCEPTIONAL RESPONDERS, TO DEVELOP WHAT'S CALLED A MASTER PROTOCOL FOR STUDYING A SMALL CELL LUNG CANCER, AND THEN A FEW OTHERS THAT WE CAN DISCUSS IF THERE'S TIME LATER ON. I THINK I'M GOING TO STOP THERE AND SEE IF THERE ARE ANY QUESTIONS. I WANT TO MOVE TO THE REVIEW OF PROPOSALS FOR YOUR CONSIDERATION INTENDED TO BE NOT ONLY A VIRTUAL MEETING BUT A SHORT ONE, BUT CERTAINLY HAPPY, AND MY COLLEAGUES ARE AS WELL, TO ENTERTAIN ANY QUESTIONS. TAKE OFF YOUR MUTE BUTTON. [INAUDIBLE] >> WE CAN'T HEAR YOU. ANY QUESTIONS FOR HAROLD BEFORE WE MOVE ON TO THE RFA'S? OKAY. THANK YOU, HAROLD. LET'S MOVE ON THEN. WE HAVE THREE REISSUED PROGRAMS FOR CONSIDERATION. WE WILL GO THROUGH THEM, PRESENTATIONS FROM NCI STAFF, WE'RE NOT REQUESTED FOR THESE BUT I WANT TO REMIND PEOPLE WE HAVE A QUARTER OF A BILLION DOLLARS ON THE TABLE FOR CONSIDERATION, SO LET'S MAKE SURE WE HAVE GOOD DISCUSSION ON THESE. THE FIRST REISSUE CONCEPT IS THE AIDS MALIGNANCY CLINICAL TRIALS CONSORTIUM, KEN ANDERSON CHAIRED THIS, BUT WAS UNABLE TO MAKE THE MEETING TODAY. STAN GERSON IS GOING TO LEAD THE DISCUSSION ALSO WITH JEFF DREBIN. SO STAN? >> I ASSUME YOU CAN HEAR ME. >> YES. >> GOOD. >> THANK YOU. TODD, THANKS FOR THE FLOOR. THE REVIEW COMMITTEE WHICH WAS IDENTIFIED FROM THE BSA ANALYZED THE ISSUES RELATED TO THE REISSUE OF THE AMC AND THE MID-CYCLE EVALUATION OF THIS CONSORTIUM, WE BASED OUR CONCLUSIONS THAT WE DIDN'T NEED A FULL PRESENTATION BY NCI STAFF ON THE QUALITY AND INFORMATION WE GATHERED FROM THE REVIEW WHICH I THINK WAS VERY CAREFULLY WRITTEN, VERY INSTRUCTIVE, AND QUITE POSITIVE. LET ME JUST REVIEW QUICKLY THAT AND OFFER SOME COMMENTS. THE MID-CYCLE EVALUATION OF THE AIDS MALIGNANCY CLINICAL TRIALS CONSORTIUM WAS LED BY FRED BANK. WANG. THEY SUPREME COUR SCORED YOU IS SUBSETS I N THE NIH SCORING SYSTEM BETWEEN METRICS OF 16 TO 46. ALL WERE LESS THAN 32, SO ALL QUITE FAVORABLE EXCEPT FOR ONE SECTION WHICH IS DESCRIBED AS SORT OF STILL IN ITS INFANCY, AND THAT IS THE BEHAVIORAL COME BACK TO THAT IF THERE ARE QUESTIONS. ON THE WHOLE, THE AMC EFFORT HAS BEEN QUITE UNIQUE, BRINGING TOGETHER ABOUT 25 CENTERS, OVER 100 PATIENTS AT THE COMPLE TRIALS, IN THE SPACE OF AIDS MALIGNANCIES PROVIDING A UNIQUE RESOURCE FOR THAT ACTIVITY THAT'S QUITE DISTINCT FROM THE FOCUS OF THE GROUPS. THERE ARE TOUCH POINTS BETWEEN THE TWO EFFORTS. WE ASKED ABOUT OVERLAP. SOMETHING OF NOTE, IS THE 40% INCREASE IN MINORITY ACCRUAL, TO THESE TRIALS. THERE ARE A NUMBER OF COMPONENTS OF THE CONSORTIUM THAT INCLUDES CORE FACILITIES, 25 SITES, INTERNATIONAL EFFORT WITH ACTIVITIES THROUGHOUT THE WORLD AND ARE MAKING MEANINGFUL CONTRIBUTIONS TO THE THERAPY OF A VARIETY OF MALIGNANCIES ASSOCIATED WITH AIDS AND NOT ONLY THOSE DEFINED AS PART OF AIDS BUT ALSO MALIGNANCY ASSOCIATED WITH AIDS. WE FOUND THAT THE REVIEWERS' COMMENTS WERE, AS I SAID, VERY CONSTRUCTIVE AND POSITIVE, FOR THE AMC AS A WHOLE AND PROVIDED SOME DETAILED GUIDELINES AND ROAD MAP FOR IMPROVEMENT THAT SHOULD BE MADE, AND SHOULD BE IMPORTANT IN THE CONSIDERATION OF THE APPLICATIONS THROUGH THE RFA. WE WERE QUITE POSITIVE. BY THE AREA OF CONCERN WAS BY REVIEWSERS, THE BEHAVIORAL GROUP, FOCUSING ON ACCRUAL SURVIVORSHIP, QUALITY OF LIFE, MEASURES, AND THEY JUST HADN'T COME TO FRUITION AS OF YET. I'LL STOP RIGHT THERE AND ASK IF THERE ARE OTHER COMMENTS FROM THE COMMITTEE. JEFF MAY HAVE SOME AND THEN WE'LL OPEN IT UP. >> ALL RIGHT. I DON'T KNOW IF EVERYBODY CAN HEAR ME. IT'S JEFF. I HAVE NO REAL ADDITIONS. I THOUGHT IT WAS A VERY STRONG PROPOSAL, GREAT TRACK RECORD OF PUBLICATION, YOU KNOW, EXCELLENT PUBLICATIONS, HIGH PROFILE JOURNALS, AND A GREAT SORT OF SO CONSORTIUM MODEL INCLUDING ALL THE IMPORTANT CENTERS IN THE COUNTRY. >> OKAY. CAN I JUST ASK ONE CLARIFYING QUESTION? THE LION'S SHARE OF THE BUDGET FOR THIS GOES TO A SINGLE CLINICAL TRIAL, WAS THERE DISCUSSION ON THE COMMITTEE ABOUT THAT? IT WASN'T CLEAR WHETHER THAT TRIAL WAS FORMALLY REVIEW ELSEWHERE AND NOW IT'S COMING UNDER THE UMBRELLA OF THE AMC OR NOT. >> I WILL HAVE TO DEFER TO NCI STAFF GIVEN THE PERSPECTIVE THIS IS TO FUND THE CON SOME THAT WOULD THEN MAKE THE DECISIONS ABOUT APPROPRIATE UTILIZATION FOR SPECIFIC CLINICAL TRIALS. WE DIDN'T TRY TO MANAGE THAT ASPECT, BUT I WOULD LOVE AN ANSWER FROM NCI STAFF. >> I CAN CLARIFY A BIT OF THAT. THE SPECIFIC TRIAL THAT IS MENTIONED -- THIS IS DR. [INAUDIBLE] IT'S A TRIAL O OF ANAL DYSPLACIA, IT NEEDS TO BE IN ORDER TO DEFINE THE PRACTICE IN THIS AREA. THE TRIAL IS, AS YOU MENTIONED, A LARGE -- QUITE LARGE TRIAL, IT'S UNDERGONE NUMEROUS REVIEWS, BOTH WITHIN AND OUTSIDE THE CANCER INSTITUTE, BOTH IN INTERNAL WORKING GROUP, AND THEN THROUGH SPL AND CTEP AND REVIEWED BY ANE AN AD HOC COMMITTEE AND WAS APPROVED ON THAT BASIS. THE BUDGET WAS SUPPLEMENTED TO PAY FOR THIS BECAUSE THEY VIEW THE TRIAL QUITE FAVORABLY. THAT I HAVE TO SAY ABOUT THE REVIEW OF THE TRIAL. MAYBE I COULD FOLLOW UP ON THIS ADDITIONAL QUESTION. WHEN A TRIAL LIKE THIS IS REVIEWED IS THAT DONE IN THE CONTEXT OF THE OPPORTUNITY COST OF OTHER AIDS-RELATED TRIALS OR IN ISOLATION? I'M FIXATED A LITTLE BIT ON THIS BEING A $66 MILLION TRIAL OUT OF $100 MILLION TOTAL BUDGET. >> YES, IT'S DONE IN THE CONTENT OF THE AIDS PORTFOLIO. IT'S A RELATIVELY SMALL PART OF THE TOTAL PORTFOLIO. THERE'S SOME MONEY THAT WAS AVAILABLE FOR THE PROGRAMMING. WE'VE USED IT FOR THE PROGRAM IN THE OFFICE OF AIDS RESEARCH. [INAUDIBLE] >> OKAY. LET'S OPEN IT UP FOR QUESTIONS. >> THE NUMBER 100 IS NOT RIGHT. >> THE NUMBER 100 IS NOT RIGHT? >> THE TOLD AIDS BUDGET IS APPROXIMATELY $260 MILLION PER YEAR, AND THIS TRIAL RANGES BETWEEN $7 AND $10 MILLION PER YEAR. >> YEAH, IT'S 66 OUT OF 104 OR SOMETHING FOR THIS, FOR THE AMC. >> CORRECT. >> OKAY. LET'S THROW IT OPEN TO QUESTIONS OR COMMENTS FROM ANYONE ON THE BOARD. >> THIS IS FRANCIS ALLEY OSMAN. THE PROJECTION WITH RESPECT TO ACCRUAL AND SO ON, HAVE THEY BEEN MET? ACCRUALS WERE UNDER THESE CIRCUMSTANCES RELATIVELY MODEST OF 100 PER YEAR, AND HAD BEEN MET. THERE WAS SOME DISCUSSION WITHIN THE SUMMARY DOCUMENT ABOUT INSTITUTIONS, AND DISTRIBUTIONS, I ASSUME IN THE RFA THAT WILL BE ADDRESSED. >> YOU MENTIONED THE BEHAVIORAL FLOOR HAS BEEN SLOWER TO START. I'M WONDER FIGURE THERE'S MORE DETAIL OR PLAN IN PLACE? IT SEEMS A LOT OF EFFORT IS GOING TO ONE PARTICULAR CLINICAL TRIAL, I WONDER IF THERE'S A PLAN TO INCLUDE A POPULATION SCIENCE COMPONENT TO THAT TRIAL? [INAUDIBLE] >> A PLAN TO INCLUDE THE QUALITY OF LIFE TO INCLUDE THAT TRIAL. >> OKAY, THANK YOU. >> THIS IS PAULETTE GRAY. LET ME ASK YOU TO PLEASE MUTE IF YOU'RE NOT TALKING. IF EVERYBODY WOULD MUTE NOW. MUTE. M-U-T-E. A COUPLE PEOPLE ARE STILL OPEN. NOBODY WANTS TO MUTE. >> OKAY. WE HAVE LOW RESOLUTION HERE. I DON'T KNOW IF THAT'S ME OR EVERYBODY. ARE THERE FURTHER QUESTIONS? OR COMMENTS? YES? >> YEAH, SO FOLLOWING UP ON TODD'S QUESTION, IS THIS A NEW CLINICAL TRIAL EFFORTOR A CONTINUATION OF THE PAST? >> THE TRIAL IS STARTING THIS YEAR. IT WILL BE CONTINUED IN THE COMPETITION. >> SO THIS WILL BE A NEW CLINICAL TRIAL STUDY, NOT A CONTINUATION OF SOMETHING THAT'S HAPPENED IN THE PAST? [INAUDIBLE] >> THERE ARE ONGOING TRIALS. >> I THINK THE QUESTION IS RELATED TO THE ANCHOR TRIAL, AND THAT TRIAL IS STARTING THIS YEAR. AND THE FIRST TWO WILL PROBABLY BE DONE IN THIS CYCLE, AND THEN THE PLAN IS THE TRIAL TO CONTINUE WITH THE REISSUANCE OF THE AMC. >> I'M CURIOUS IN TERMS OF THE SIZE OF THE BUDGET, IF IT HAS BEEN INVESTED IN PREVIOUS ACTIVITIES, WHAT WERE SOME OF THE HIGHLIGHTS THAT'S BEEN ACHIEVED, SO THAT'S ALL I WAS CURIOUS ABOUT. >> IT'S INCLUDED IN THE DOCUMENTS, SOME HIGHLIGHTS HAVE BEEN THE DEFINITION OF -- [INAUDIBLE] A NUMBER OF TRIALS DEFINE THE USE OF HIGH LEVEL CHEMOTHERAPY FOR LYMPHOMA AND DIFFERENT TYPES OF LYMPHOMA. THERE'S ALSO BEEN A SUBSTANTIAL EFFORT WITHIN THE CURRENT PROGRAM TO DEFINE THE BEST TREATMENT FOR ANAL DYSPLASIA AND OTHER FORMS, CONSIDERED THE BACK DROP TO DEVELOPING THE CANCER TRIAL TO WORK ON ANAL CANCER. >> OKAY. ANY REMAINING -- >> A POINT. SPECIMEN ACQUISITION AS PART OF THE CLINICAL TRIALS, HAS THIS BEEN REALIZED, THE DIFFERENT CENTERS, THE ACQUISITION? >> THE SPECIMENS THAT ARE COLLECTED ON THE AMC ARE GENERALLY -- [INAUDIBLE] -- WHICH HAS BEEN AVAILABLE TO INVESTIGATORS. THE TRIAL IS TO HOLD THE SPECIMENS UNTIL IT'S DETERMINED WHICH PATIENTS DEVELOP CANCERAND THEN TO MAKE THESE AVAILABLE TO THE GENERAL COMMUNITY IN OPEN COMPETITION. >> THIS IS GOING TOWARD THE CLINICAL DATA, TREATMENT OUTCOMES, YOU KNOW, FOR FUTURE. THIS IS VERY CRITICAL ULTIMATELY IN TRYING TO UNDERSTAND SOME OF THE FUNDAMENTAL BIOLOGY, YOU KNOW. SO WE'LL HAVE TO LOOK AT THAT CAREFULLY. >> TO BE HONEST GIVEN THE ACCOMPLISHMENTS OF THE STRUCTURE, WE EMPHASIZE VIEW OF THE STRUCTURE AND REVIEW COMMITTEES AND WE DIDN'T TRY TO INSTITUTE THE FUTURE RFA AND RESPONSE. WE'RE AFFIDAVI AFTER ALL TALKING ABOUT RE-ISSUE, NOT APPLICATION. I DON'T HAVE A PERSPECTIVE ON YOUR QUESTION. >> OTHER COMMENTS? >> YES, THIS IS ELENA MARTINEZ. IN THE BEHAVIOR WORKING GROUP IT'S NOTED THE FINDING IS COMING FROM THE HEALTH DISPARITIES. IS THAT THE ONLY SOURCE OF FUNDING FOR THE WORKING GROUP OR IS THERE ADDICTIONAL FUNDING? [INAUDIBLE] >> I'M SORRY, I DIDN'T UNDERSTAND THE ANSWER. [INAUDIBLE] >> THANK YOU. >> OKAY. IF THERE ARE NO FURTHER QUESTIONS, STAN, WOULD YOU LIKE TO MAKE A MOTION ON THIS PROPOSAL? >> THANKS, TODD. WE WOULD MOVE THAT THE COMMITTEE ACCEPT THE RECOMMENDATION TO REISSUE THE RFA FOR THE AIDS MA LAYING CRITICAL CONDITION TALLAHASSEE TRIALS CONSORTIUM AND RECOMMENDATIONS FOR THE MID-CYCLE EVALUATION. >> IS THERE A SECOND? >> SECOND. >> ANY FURTHER DISCUSSION? SO WE HAVE A BIT OF A LOWE LOGISTICAL CHALLENGE. FOR THOSE OPPOSED, SAY SO. OR THOSE THAT ARE ABSTAINING WILL SAY SO. IF YOU'RE SILENT WE WILL ASSUME THAT YOU ARE VOTING IN FAVOR. SO THOSE OPPOSED? WE REPORT ZERO. ANY ABSTENTIONS? OKAY. PAULETTE, THAT SOUNDS LIKE A UNANIMOUS VOTE IN FAVOR. , IF I'FAVOR, IF I'M NOT MISTAKEN. OKAY, THANK YOU VERY MUCH. NOW WE MOVE TO THE SECOND RFA, THE CENTERS FOR CANCER NANOTECHNOLOGY EXCELLENCE, THIS COMMITTEE WAS CHAIRED BY JOE GRAY. JOE? >> CAN YOU HEAR ME? CAN YOU HEA ME? >> YES. >> EXCELLENT. OKAY. SO THE COMMITTEE MET ON FEBRUARY 14, AND REVIEWED THE PROGRAM, AND I THINK THAT OVERALL WE'RE VERY ENTHUSIASTIC ABOUT WHAT WE HEARD, AND STRONGLY SUPPORTED A ONE-TIME REISSUANCE AND DIDN'T FEEL WE NEEDED -- [INAUDIBLE] -- AT THIS TIME. AN IMPORTANT PROGRAM IN THE PORTFOLIO, IT'S BEEN QUITE PRODUCTIVE IN TERMS OF SUPPORTING ASPECTS OF ONCOLOGY, CLINICAL RESEARCH, NANO PARTICLE FUNCTIONAL CHARACTER CHARACTERIZATION, IN VITRO AND CLINICAL MODELS. IT'S BEEN ACTUALLY QUITE REMARKABLY EFFECTIVE IN GENERATING A MULTI-DISCIPLINARY RESEARCH COMMUNITY AND PRODUCTIVITY OF THE PROGRAM IN OUR VIEW HAS BEEN OUTSTANDING, BOTH IN TERMS OF THE NUMBER AND QUALITY AND ALSO IN TERMS OF THE NUMBER OF CLINICAL TRIALS INITIATED USING THE NANOTAO*ERL NANOMATERIALS. A REPORT CITED THE SUMMARY OF THE CCNE PROGRAMS AND THE FIELD ND I THINK WE FELT THAT AT IN GENERAL. LEAST FOR SOME ASPECTS OF THAT PROGRAM OUGHT TO BE MADE PUBLICLY AVAILABLE PERHAPS BY POSTING SOME SORT OF SITE. WE THOUGHT THAT THE RFA MECHANISM WAS GOOD, IN THE PAST GENERATED A COHESIVE PROGRAM, AND CONTINUED. ALSO THOUGHT THAT THE IDEAS FOR THIS RFA WAS APPROPRIATE GIVEN THE SUCCESSFUL PAST HISTORY. WE WERE SURPRISED TO SEE THE BUDGET HAD BEEN CUT, BUT THAT'S A NOTE IN PASSING. WE THOUGHT THAT ALTHOUGH WE DIDN'T CALL FOR A PRESENTATION OF THE PROGRAM, WE DID THINK WHAT WE HEARD AND READ WAS SUFFICIENTLY IMPRESSIVE THAT WE WOULD RECOMMEND THAT AT SOME FUTURE TIME, PERHAPS WE HAVE A PRESENTATION FOR THIS PROGRAM, JUST SO THAT WE CAN BENEFIT FROM THE LESSONS LEARNED IN THIS VERY IF YOU CANEL IS BRING TOGETHER ASFUL EFFORT TO MULTI-DISCIPLINARY PROGRAM. I THINK IT'S BROUGHT TOGETHER A GREAT GROUP OF INDIVIDUALS FROM ACADEMIA, INDUSTRY AND SO ON TOGETHER, AND WE LOOK FORWARD TO ITS CONTINUATION. THE FREDERICK NATIONAL LABORATORY, IT WAS FELT THAT THE FREDERICK NATIONAL LABORATORY DID PLAY A SUBSTANTIAL ROLE IN THE NANOMATERIALS PROCESS, SINCE THE FRET RIC FREDERICK NATIONAL LAB IS THINKING ABOUT FUTURE DIRECTION, IT'S ONE OF THE THINGS WE WOULD LIKE TO PUT ON THE TABLE FOR PERHAPS DISCUSSION IN THE FUTURE, THE IDEA THAT THE FREDERICK LAB MIGHT PLAY AN EVEN LARGER ROLE IN THIS PROGRAM. SO WITH THAT, I THINK WE ALL WERE ENTHUSIASTIC. 'M NOT SURE WHETHER VERY HAVE ANITA ON THE PHONE. DO WE HAVE YOU? NOPE. JOSHUA, ANY COMMENTS? >> YOU CAN ALL HEAR ME? >> YES. >>> WE USED TO HAVE A GOOD VISUAL, NOW IT'S COMING AND GOING. I DON'T KNOW IF THEY SWITCHED THE IMAGE BUT IT'S GOTTEN WORSE. I DON'T HAVE A LOT TO ADD TO WHAT JOE JUST SAID, JUST A COUPLE QUICK POINTS. FIRST OF ALL, I THINK THIS IS THE PROGRAM REPRESENTATIVE OF THE KIND OF THING I THINK AN RFA DOES WELL, WHICH IS TO TAKE A FIELD THAT NEEDS ENCOURAGEMENT, THEY SHOW DATA IN THE PRESENTATION HERE THAT, YOU KNOW, INITIALLY THERE ROEN'T A LOT OF GRANTS, THE O 1RO-1 4, BY ORGANIZING IT IN AN ALLIANCE LIKE THIS, INTERCOMMUNICATION, IMPROVING THE QUALITY AND LED TO HIGH OUTPUT IN TERMS OF WHAT JOE SAID IN TERMS OF PUBLICATIONS AS WELL AS PATENTS, THERE HAVE BEEN 39 ISSUED PATENTS, AND AT LEAST A HUNDRED MORE APPLICATIONS GOING ON. I THINK THERE WAS A 160-PAGE DOCUMENT, ALL OF IT IS OUTSTANDING SO I'M VERY SUPPORTIVE OF CONTINUING. >> OKAY. SOUNDS LIKE THERE'S A LOT OF ENTHUSIASM. THE FLOOR IS OPEN FOR QUESTIONS. >> ALL RIGHT. TODD, ONE BRIEF COMMENT. THE SCIENTIFIC PROGRAM LEADERS WHEN THEY REVIEW THIS WERE STRONGLY SUPPORTIVE BUT WERE COGNIZANT OF THE IDEA RFA'S CANNOT GO ON FOREVER. THIS IS THE THIRD ISSUE, IT WILL BE THE THIRD ISSUANCE, AND WE WOULD BE GRATEFUL FOR COMMENTS FROM THE MEMBERS ABOUT WHETHER THERE ARE CRITERIA YOU WOULD LIKE TO SEE FULFILLED IN THE NEXT ITERATION THAT WOULD INCOURAGE OR DISCOURAGE A SUBSEQUENT REISSUANCE. WE RECOGNIZE THIS IS A NEW FIELD, THIS INITIATIVE IS DONE WELL, BUT AT CERTAIN POINT NANOTECHNOLOGY BECOMES PART OF THE GENERAL LEXICON OF DOING CANCER RESEARCH AND WE WELCOME ANY SUGGESTIONS FOR HOW WE DETERMINE WHETHER OR NOT THAT THRESHOLD HAS BEEN REACHED. I'M SORRY, THERE'S BEEN A LOT OF LOCAL DIFFICULTIES HERE WITH THE FEED. CAN NOD YOUR HEAD IF YOU HEAR ME NOW. ALL RIGHT. YOU DIDN'T HEAR ME PREVIOUSLY? YOU DID NOT? OKAY. LET ME REPEAT MYSELF, PERHAPS EVEN MORE ELOQUENTLY THAN THE FIRST TIME. [LAUGHTER] SO THE SCIENTIFIC PROGRAM LEADERS, SPL, IN REVIEWING THIS PROPOSAL GAVE IT VERY STRONG SUPPORT. BUT THE SPL OPERATES IN AN ERA IN WHICH BUDGETS ARE DECREASING, CERTAINLY NOT INCREASING, AND WE ARE VERY AWARE OF THE NEED TO TERMINATE SOME PROGRAMS THAT CAN'T GO ON FOREVER. SO IN THINKING ABOUT THIS PROGRAM, WHICH HAS BEEN SUCCESSFUL, WE ARE LOOKING TO YOU FOR ADVICE ABOUT WHAT KIND OF CRITERIA OUGHT TO BE FULFILLED IN THIS, WHICH WOULD BE THE THIRD ITERATION OF THIS PROGRAM, THAT WOULD ENCOURAGE US TO THINK ABOUT WHETHER THERE SHOULD BE A FOURTH ITERATION. WE RECOGNIZE THERE'S A NEED TO DEVELOP NEW TECHNOLOGY THROUGH PROGRAMS OF THIS KIND, AT A CERTAIN POINT THE TECHNOLOGIES DO BECOME EXPERT AND THE NEED TO HAVE SOME KIND OF ADDITIONAL SET-ASIDE SUPPORT FOR THESE PROGRAMS IS NO LONGER MANDATORY. SO ANY ADVICE YOU CAN GIVE US ALONG THOSE LINES WOULD BE USEFUL. IN ADDITION, I WELCOME THE SUGGESTION TO HAVE A PRESENTATION OF THE NANOTECHNOLOGY INITIATIVE AT A SUBSEQUENT BSA MEETING AND I USE THAT RECOMMENDATION AS OF A PLATFORM, ASKING FOR OTHER SUGGESTIONS FOR TOPICS TO PURSUE AT OUR SUBSEQUENT BSA MEETINGS, SUBJECTS THAT BRING US INTO THE REALM, ESPECIALLY OF DECIDING WHAT KINDS OF THINGS YOU WANT TO BE DELIBERATING ABOUT IN THE TIME THAT'S NOT DEVOTED TO THESE SPECIFIC PROPOSALS. >> THE FIRST QUESTION IS A GOOD ONE. I DON'T KNOW IF ANYONE CAN HEAR ME. ONE SUGGESTION FOR THE NEXT PROGRAM WOULD BE WHY CAN'T INFORMATION MOVE DOWN THETCHING PIPELINE, CLINICAL OR TRANSLATIONAL APPLICATION, I THINK THEY ARE WELL ON THEIR WAY. THERE ARE PATENTS THAT HAVE BEEN ISSUED NOW, AND SO ONE WOULD HOPE TO START SEEING THEM ACTUALLY APPEAR. THAT WILL BE ONE MEASURE. >> WE AGREE ON GENERAL PRINCIPLE, BUT PERHAPS A MORE CONCRETE CRITERIA WOULD BE -- [INAUDIBLE] REISSUANCE STARTING IN 2004, IT'S NOW TEN YEARS, IT WOULD BE VERY HELP -- WE SHOULD BE THINKING ACTIVELY ABOUT WHEN IT ENDS. >> THE REPORT WAS THE CONCEPT THAT THE NUMBER OF RO-1'S IN THIS GENERAL SPACE WAS INCREASING BUT STILL NOT WELL REPRESENTED, SO I THINK ONE OF THE CRITERIA THAT WE MIGHT THINK ABOUT IN THE FUTURE IS TO SORT OF TRACK THE EMERGENCE OF THIS FIELD IN THE RO-1 COMMUNITY IN THIS COMMUNITY AND OTHER COMMUNITIES, I DON'T KNOW HOW TO QUANTIFY THAT YET BUT I THINK THAT AS IT STARTS TO GROW IN THAT SPACE, THEN WE OUGHT TO THINK ABOUT TAKING IT OUT. >> YOU KNOW, I DON'T KNOW IF YOU HEARD ME BEFORE, THE QUESTION I HAD WAS, I MEAN, I'M SUPPORTIVE OF THIS PROGRAM. I THINK IT'S BEEN VERY SUCCESSFUL. HOWEVER, IT IS NOW QUITE A MATURE FIELD. I DON'T THINK R O 1' RO-1'S ARE A GOOD MEASURE BECAUSE OFTEN TIMES TH IS RELATIVELY EXPENSIVE SCIENCE TO DO AND RAPIDLY ENGINEERS TRANSLATE THEIR STUFF INTO INDUSTRY, MUCH FASTER THAN WE WOULD DO IT IN OTHER AREAS OF CANCER RESEARCH. SO THE QUESTION IS, THE NIH MUST HAVE OTHER INITIATIVES IN NANOTECHNOLOGY TO SUPPORT NANOTECHNOLOGY DEVELOPMENT. OUTSIDE OF THE NCI, WHETHER IT'S TIME TO START COORDINATING SOME OF THOSE EFFORTS, PARTICULARLY IN THE DEVELOPMENT OF DRUG DELIVERY TECHNOLOGY AND MONITORING TECHNOLOGIES, WITH OTHER AREAS SUCH AS DIABETES AND OTHER THINGS THAT I KNOW ARE GOING ON. HAS THERE BEEN ANY ATTEMPT TO DO THAT? DID YOU HEAR WHAT I SAID, TODD? >> YES. >> ORGANIZING A RESPONSE FROM PETER. >> THIS IS PETER FROM NCI. THERE ARE OTHER PROGRAMS WITHIN NIH ON NANOTECHNOLOGY, ONE PROGRAM OF NOTE, THE PROGRAM OF EXCELLENCE. NHLDI, WHICH WILL START ABOUT THE SAME TIME AS THIS ONE, THERE WAS ALSO A PROGRAM WHICH WAS PART OF THE NIH ROAD MAP WHICH WAS MORE BASIC IN NATURE, AND SOME OF THIS TECH NOR TECHNOLOGY IT PLATFORM-LIKE,E,ED,ED CAN, CAN BE USED IN APPLICATIONS FOR DIFFERENCE DISEASES. SOME TRANSLATIONAL SUPPORTS FOR ACTIVITIES LIKE THAT CAN BE COORDINATED ON NIH LEVEL, RATHER THAN INDIVIDUAL INSTITUTE LEVEL, SO THAT WILL HELP LOOKING AT THE PLATFORM NATURE OF THAT AND REAPPLICATION OF THAT TO DIFFERENT DISEASES. YOUR POINT IS WELL TAKEN BUT WE'RE LOOKING AT IT ALREADY. >> I THINK THAT RAISES THE ISSUE IN DETERMINING WHAT TYPE OF THINGS TO SUPPORT, THE PLATFORM, BASIC PLATFORM SHOULD BE DISCOURAGED FROM THE NCI AND THERE SHOULD BE A REAL FOCUS ON CANCER IN THESE, AND I AGREE WITH THE SUGGESTION SINCE THIS IS A RELATIVELY MATURE AREA, EVEN IN INDUSTRY NOW, THAT SOME TRANSLATIONAL CRITERIA BE INCLUDED IN THIS. >> YEAH, I WANTED TO COMMENT ON THAT ALSO. I SUPPOSE YOU COULD SAY THE FIELD IS MATURE IN SOME RESPECTS, BUT ITS APPLICATION TO CANCER RESEARCH, TO ME, STILL SEEMS THEY, VER VERY, VERY EARLY AND STILL NEEDS SERIOUS ENCOURAGEMENT. THAT CERTAINLY IS NOT -- MOST PEOPLE IN THE CANCER RESEARCH FIELD ARE NOT THINKING ABOUT HOW TO REALLY USE THESE TECHNOLOGIES, WHAT ASPECTS ARE AND WHAT'S NOT,ANNED WHAT'S IT'S APPROPRIATE FOR NCI TO TARGET SUPPORT UNTIL THE ISSUES ARE CLEAR. >> YEAH, HOWEVER, ON THE OPPOSITE SIDE OF THAT, MOST OF THE NANOTECHNOLOGY DEVELOPMENT LABORATORIES IN THE COUNTRY HAVE STOPPE GOT FUNDING FROM NCI TO DEVELOP INFRASTRUCTURE PLATFORMS OR DEVELOPMENT NANOTECHNOLOGY, AND THOSE OF COURSE OVERLAP WITH WHAT I JUST SAID BEFORE, OTHER INSTITUTE-FUNDED THINGS SO I THINK THE NCI SHOULD FOCUS ON CANCER RESEARCH. >> OKAY, OTHER QUESTIONS? >> MAY I INTERJECT HERE? SO PETER FROM NCI AGAIN. ALL PROGRAMS, ALL PROJECTS WHICH WERE FUNDED CURRENTLY ARE DEDICATED TO CANCER. I WAS JUST SAYING POTENTIALLY SOME OF THIS TECHNOLOGY CONCEPT CAN BE USED TO OTHER DISEASES BUT THE WHOLE PURPOSE OF THIS PROGRAM WAS ACTUALLY TO GRINNING TOGETHER TECHNOLOGY AND ONCOLOGY BECAUSE FROM THE TECHNOLOGY STANDPOINT OF NANO PARTICLES OR NANO DEVICES, YES, THEY PROBABLY HAVE MATURED TO A CERTAIN LEVEL BUT WHEN IT COMES TO USING THEM TO SOLVING CERTAIN PROBLEMS, OR DEVELOPING NEW THERAPIES AND DIAGNOSTICS, THE GUIDANCE FROM AN KOE CANCER AND ONCOLOGY IS NECESSARY, AND THE PROCESS HAS STARTED BUT THAT LEVEL IS NOT AS HIGH AS THE DEVELOPMENT OF THE TECHNOLOGY ITSELF. THANK YOU. >> THIS IS FRANK TORTI. I WANT TO GET BACK TO HAROLD'S ORIGINAL QUESTION. YOU KNOW, IT STRIKES ME THAT VIRTUALLY NONE OF THE PROGRAMS THAT WE HEAR ABOUT ARE NOT OF VALUE. THEY ARE ALL OF SOME VALUE. THERE'S NO QUESTION ABOUT IT. YOU WOULD EXPECT THAT BECAUSE THEY HAVE BEEN CAREFULLY -- [INAUDIBLE] AND WE RARELY RECOMMEND THAT PROGRAM IS TERMINATED AS WELL. I JUST WONDER IF -- WHEN THESE PROGRAMS ARE INITIATED, NOW NOT SPEAKING SPECIFICALLY ABOUT NANOTECHNOLOGY PROGRAM BUT GENERALLY, WHEN THESE LARGE PROGRAMS ARE INITIATED, MAYBE THEY SHOULD BE -- ANYBODY [INAUDIBLE] -- SO A SUCCESSFUL PROGRAM, FIVE YEARS, TEN YEARS, SHOULD HAVE AN END DATE AND WHAT WOULD HAVE TO COME HERE AND ARGUE NOT TO TERMINATE THE PROGRAM AS OPPOSED TO JUST FUND THE PROGRAM. THE TURNOVER OF DOLLARS IN NEW PROGRAMS IS HAMPERED BY THE CONTINUATION OF SOME OF THESE PROGRAMS THAT MAYBE HAVE A LEGACY AND I THINK ALL OF US AROUND THE TABLE, I DON'T KNOW WHAT OTHERS THINK ABOUT THAT. >> OTHER COMMENTS? THIS WOULD BE A DEFINED PERIOD, AND THEN IT ENDS. >> LUIS PARADA, CAN YOU HEAR ME? HELLO? OKAY. I JUST SIMPLY WANT TO, NUMBER ONE, AGREE WITH WHAT BRUCE HAD TO SAY AND ALSO TO THE COMMENTS, ONE OF THE GREAT THIS COMMITTEE IS A TREMENDOUS I THINK RELUCTANCE TO NOT QUESTION PROGRAMS BECAUSE ALL THE PROGRAMS HAVE INTRINSIC VALUE. BUT AT A TIME WHEN FUNDING IS SO DIFFICULT, I THINK IT'S CRITICAL TO MAKE SURE THAT EACH PROGRAM IS SOME SORT OF ASCENDANT AS OPPOSED TO LET'S MAKE SURE IT EXISTS. IF IT ISN'T ASCENDANT TO HAVE GOOD CLEAR JUSTIFICATION OF SUNSET APPEALS TO ME. >> THIS IS BRUCE AGAIN. YOU KNOW, ONE OF THE THINGS THAT DRIVES THE REQUESTS FOR CENTERS IS THE FACT THAT AS I SAID BEFORE, PARTICULARLY THIS TYPE OF RESEARCH IS COLLABORATIVE, IT'S ALSO VERY EXPENSIVE. OR IT CAN BE EXPENSIVE, PARTICULARLY IF YOU'RE TRYING TO TRANSLATE SOME OF THIS INTO THE CLINIC. I THINK THE NCI SHOULD THINK ABOUT AN ALTERNATIVE, AND THIS COULD GO ACROSS DIFFERENT AREAS OF SCIENCE, NOT JUST NANOTECHNOLOGY, INSTEAD OF ISSUING THESE RFA'S, WHATEVER THIS $75 MILLION IS, SOME OF THIS MONEY COULD BE USED BY HAVING A GRANT MECHANISM WITH INVESTIGATORS, AND I MEAN INVESTIGATOR-INITIATED RESEARCH, WOULD GET UP TO, YOU KNOW, SOMETHING LIKE A MILLION COLLABORATIVE RO-1 IS NOT THE DOLLARS A YEAR TO DO SOMETHING. TYPE OF MONEY YOU CAN SUPPORT THIS TYPE OF EFFORT. INDIRECTLY BETWEEN NANOTECHNOLOGY AND ONCOLOGISTS, IF THERE WAS A GRANT MECHANISM TO DO THIS, A STATED GRANT MECHANISM, NOT SOMETHING YOU HAVE TO DO A DEAL WITH UP FRONT AND IT DOESN'T GO TO A STUDY SECTION WITH NO CLUE ABOUT WHAT THE NIH WANTS, I THINK CSR -- [INAUDIBLE] -- WHAT THIS BOARD ENDORSES. THAT'S ONE SUGGESTION FOR THE FUTURE ON HOW TO TRANSLATE THESE THINGS. THAT COULD GO ACROSS LOTS OF AREAS. >> OTHER COMMENTS? >> YEAH, THIS IS JOSH. I DON'T KNOW IF YOU CAN HEAR ME. I THINK THAT SOME OF WHAT DRIVES THESE RFA'S, AT LEAST IN MY VIEW, RECOGNIZING THERE'S AN AREA OF RESEARCH THAT IS GETTING LESS ATTENTION THAN IT NEEDS, AND TRYING TO ATTRACT SCIENTISTS TO THAT AREA. SOMETIMES THAT CAN HAPPEN THROUGH RO-1'S BUT OFTEN TIMES WITH RO-1'S, PEOPLE DO A LITTLE BIT OF WORK AND WALK AWAY AND DO SOMETHING DIFFERENT. IF YOU SEE AN AREA OF RESEARCH THAT NEEDS ATTENTION, DEVELOPMENT, YOU TRY TO ATTRACT PEOPLE TO THAT. I THINK THE TIME TO SUNSET THAT IS WHEN YOU REALIZE THAT AREA NO LONGER NEEDS ATTRACTION, PEOPLE ARE THERE, IT'S GETTING DONE OR THAT AREA IS NO LONGER NEEDED FOR SOME REASON. IT HAS TO BE TOPIC SPECIFIC. IF WE SEE NANOTECHNOLOGY IS NEEDED, IF WE THINK IT HAS AN OPPORTUNITY TO MAKE A DIFFERENT -- EITHER IN RESEARCH FORM OR CLINICAL FORM, YOU ATTRACT PEOPLE TO THAT. IF WE THINK THAT AREA DOESN'T REALLY NEED ATTENTION, THAT WOULD BE A DIFFERENT CHOICE. BUT I THINK RO-1'S ARE GREAT FOR SOME TYPES OF RESEARCH. OTHER AREAS YOU NEED A MORE COORDINATED EFFORT, NOT JUST MORE MONEY BUT COORDINATION, I THINK THAT'S WHERE YOU WANT TO PUT AN FRA. AN RFA. >> OTHER COMMENTS? >> YEAH, THIS IS JOE. PROBLEONE OF THE THINGS I THINK THE RFA DOES, PARTICULARLY WELL, IS TO BRING TOGETHER A MULTI-DISCIPLINARY COMMUNITY, SO IT'S NOT JUST EXPENSIVE -- IT IS EXPENSIVE, IT'S ALSO THE CASE THAT IN SOME OF THESE, INTERACTING TOGETHER, DON'T NECESSARILY KNOW EACH OTHER, SO ONE OF THE PURPOSES OF RFA'S IS TO BUILD THAT MULTI-DISCIPLINARY COMMUNITY. PERSONALLY READING ON THIS, THOUGHT THIS COMMUNITY WAS COMING TOGETHER NICELY AS A RESULT OF THIS RFA AND IT'S NOT THERE YET IN TERMS OF BEING ABLE TO SELF ASSEMBLE INTO RO-1'S OR SUPER RO-1'S AS CHRIS WAS TALKING ABOUT BUT IT'S GETTING THERE. >> HI. ONE OTHER QUICK THOUGHT. ANOTHER POTENTIAL APPLICATION HERE IS THAT BY ORGANIZING INTO KIND OF ALLIANCE, I THINK THAT'S ANOTHER AREA WHEREBY SETTING STANDARDS WE ENSURE EVERYBODY DOES HIGHER LEVEL WORK AND MORE BELIEVABLE WORK, IF YOU WILL. >> I'M HEARING ENTHUSIASM BUT ALSO SOME QUESTIONS, WOULD ANYONE LIKE TO MAKE THE CASE THAT THE TIME FOR SUNSET IS NOW, BECAUSE THE APPROACH IS OFF TO THE RACES? OKAY. JOE, WOULD YOU LIKE TO MAKE A RECOMMENDATION? >> YES, I RECOMMEND THAT WE APPROVE THE ONE-TIME ENROLL OF THIS RFA. >> IS THERE A SECOND? >> I'LL SECOND IT. >> ANY FURTHER DISCUSSION? AGAIN, WE'LL CALL -- >> I WOULD JUST LIKE TO FOLLOW WHAT BRUCE SAID ABOUT TRANSLATIONAL, YOU KNOW -- MAYBE IN LIGHT OF THE -- YOU KNOW, IT'S RECOMMENDED THAT EFFORTS SHOULD BE BASED ON TRYING TO TRANSLATE IN VIVO INTO THE CLINIC, AS OPPOSED TO TECHNOLOGY, FUNDAMENTAL TECHNOLOGY. I THINK THAT IF WE THINK OF ONE TIME AND THINK OF SUNSET, IT WOULD BE GOOD, I THINK WE HAVE 25 NEW TECHNOLOGIES. [INAUDIBLE] THIS IS WHERE IT WOULD BE A GOOD IDEA. >> OKAY. THANK YOU. SO WE'LL NOW VOTE ON THE MOTION TO REISSUE WITH THE STRONG RECOMMENDATION TO NCI STAFF THE RFA BE WRITTEN IN SUCH A WAY AS TO ENCOURAGE AND REWARD APPLICANTS THAT ARE PARTICULARLY CANCER AND TRANSLATIONALLY FOCUSED. ALL OPPOSED TO THIS MOTION? ANY ABSTENTIONS? >> I THINK I HAVE TO ABSTAIN. I THINK WE HAVE ONE AT OUR INSTITUTION. >> OKAY. ANY OTHERS? OKAY. ONE ABSTENTION. A MOTION PASSES. THE MOTION PASSES. THANK YOU VERY MUCH. OKAY, THE LAST CONCEPT IS CISNET. KAREN EVANS, ON THE PHONE, CHAIRED THIS COMMITTEE. >> CAN YOU HEAR ME? >> YES. >> OKAY. >> I CHAIRED THIS COMMITTEE WITH BASCH AND HUSBAN HUBBERT. WE REVIEWED THE REPORT FROM THE EXTERNAL EVALUATION, AND RECOMMENDED THAT THERE WOULD BE NO PRESENTATION. WE THOUGHT THE MATERIALS PROVIDED WERE REALLY EXCELLENT. WE DID POSE SOME QUESTIONS THAT WE GOT ANSWERED BY PROGRAM, I'LL BRIEFLY REVIEW THAT. THIS IS FOR A REISSUANCE THAT WOULD PROPOSE UP TO SIX FIVE-YEAR COOPERATIVE AGREEMENTS, FOCUSED ON DIFFERENT SITES. ESSENTIALLY WHAT CONSORTIUMIVE INVESTIGATORS DOES IS USE SIMULATION MODELING TO IMPROVE THE UNDERSTANDING OF THE IMPACT THAT CANCER CONTROL INTERVENTIONS HAVE ON POPULATION INCIDENTS AND MORE AT THAT TIME. MORTALITY. THERE WILL BE A SERIES OF CANCERS FOCUSED ON BREAST, PROSTATE, COA COLO-RECTAL AND ADDING CERVICAL AS WELL. THE COLLABORATION TO DATE USED A WIDE RANGE OF MODELS AND METHODS TO ANSWER QUESTIONS LOOKING AT EMERGING CANCER TRENDS, HOW DIFFERENT INTERVENTIONS COME ALONG MIGHT IMPACT ON FUTURE TRENDS, AND REALLY TO IDENTIFY THE VERY BEST STRATEGIES FOR REDUCING CANCER BURDEN. THE RULES O USEEL MODELING USE OF MODELIN G, THEY HAVE BEEN LEADERS OF THE PACK, DEVELOPING STRATEGIES NOW CONSIDERED TO BE STATE OF THE ART INTERNATIONALLY. AND WHAT THEY ARE TRYING TO DO IS TO REALLY NARROW THE GAP BETWEEN INNOVATION IN BIOMED SIDS ABIOMEDICINE AND INFLUENCE ON HEALTH. A THOROUGH REVIEW WAS DONE AND WE LARGELY CONCURRED WITH THEIR ENTHUSIASM. VERY PRODUCTIVE, THEY HAVE OVER THE COURSE OF THEIR FUNDING REALLY PRODUCED A LOT OF NEW KNOWLEDGE THER IN IMPORTANT AREAS, IN PARTICULAR EVALUATING NEW SCREENING STRA*T JUS STRATEGIES, TRYING T O ESTIMATE HEALTH BE AND COST EFFECTIVENESS LOOKING AT THE POLICY LEVEL SUPPORTING EVIDENCE-BASED GUIDELINES AND POLICY IMPLICATIONS AROUND THE STATE AND LOCAL AND NATIONAL CANCER CONTROL PLANNING. THE REVIEWERS NOTED IN PARTICULAR THERE'S BEEN A LOT OF PRODUCTIVITY IN PROVIDING SUPPORT FOR GUIDELINES DEVELOPMENT. LOOKING AHEAD, I THINK THERE'S A LOT OF THINGS HAPPENING RELATED TO AFFORDABLE CARE ACT AND NO ROLE OF GUIDELINES TO PROVIDE AN OPPORTUNITY FOR THIS GROUP TO YET MAKE ANOTHER LEAP FORWARD IN TERMS OF THINKING ABOUT THE MODELS THEY ARE USING AND USING MORE UPDATED MODELS THAT WILL HELP, AGAIN, TO CONTINUE TO GROW THE FIELD. THE COMMITTEE, OUR SUBCOMMITTEE, FELT VERY SIMILAR TO WHAT THE REVIEWERS DID, THAT THERE'S BEEN VERY GOOD WORK AMONG THESE INTENSIVELY FOCUSED MODEL HERS AND NOW THE STRATEGY SHOULD BE TO TRY TO ENGAGE OTHERS IN THE MODELS THEY DEVELOPED, TRYING TO DEVELOP MORE TRANSPARENC TRANSPARENCY AROUND MODELS, USER FRIENDLY MODELS WILL MAKE IT MORE ACCESSIBLE TO OTHERS, THAT'S SOMETHING THAT WAS RECOMMENDED GOING FORWARD. THE SUBCOMMITTEE, AGAIN, FELT ALTHOUGH THEY HAVE DONE A REALLY EXCELLENT JOB, THAT THERE COULD BE MUCH MORE DONE IN THE AREA OF DISPARITIES, AND THE RESPONSE FROM PROGRAM ON THIS SUGGESTS THERE MAY HAVE BEEN A PRESENTATION ISSUE THAT THE DISPARITIES WORK WAS NOT CALLED OUT PER SE BUT THERE'S A REAL CONTRIBUTION THIS WORK CAN MAKE IN THAT REGARD AND WE WOULD LOVE TO SEE THAT INCORPORATED STRONGLY AND THERE WERE SOME GREAT SUGGESTIONS FROM PROGRAM ABOUT HOW TO DO THAT. AND THEN I THINK OVERALL WE FELT THIS WAS QUITE RESPONSIVE TO THE CONCERNS THAT HAD BEEN RAISED IN THE RESPONSE FROM PROGRAM, I WANTED TO NOTE THAT WE HAD QUESTIONED THE ROLE OF PATIENT-CENTERED RESEARCH WHICH AS YOU KNOW IS GROWING MORE AND MORE AND THERE WAS REALLY THOUGHT EXCELLENT RESPONSE IN TERMS OF THE COLLABORATION WITH CORY AND TRYING TO ENGAGE WITH PECORI IN WAYS THAT WILL BE EFFECTIVE AS THIS MOVED FORWARD. THAT'S ESSENTIALLY MY QUICK SUMMARY AND I'LL LET ETHAN AND SHANITA ADD ANY COMMENTS THEY WOULD LIKE. >> SHANITA? >> THANK YOU. I DON'T HAVE ANYTHING TO ADD TO KAREN. I WOULD ECHO HER COMMENTS ON ENTHUSIASM ON THIS PROGRAM. >> THANK YOU. ETHAN? >> I AGREE. I THINK KAREN SUMMED IT UP NICELY. I'D LIKE TO ECHO THAT WE ALL DID AGREE THAT GREATER TRANSPARENCY AROUND THE MODELING TECHNIQUES WOULD BE VERY HELPFUL FOR THE GROUP AND COMMUNITY MOVING FORWARD, AND WE ALSO AGREED WITH INCLUDING CERVICAL CANCER IN THE UPCOMING ANNOUNCEMENT. >> OPENING WITH ONE QUESTION AND WE'LL OPEN IT UP TO THE BOARD. WAS THERE ANY DISCUSSION AROUND NONORGAN SITE-BASED WAYS OF ORGANIZING CISNET? >> I DON'T BELIEVE SO. I DON'T KNOW IF A PROGRAM IS THERE AND THEY CAN SPEAK TO THAT ISSUE, BUT I DON'T BELIEVE SO. THERE IS A VERY CLEAR DESCRIPTION ABOUT HOW THEY CHOOSE A CANCER SITE, AND SO THEY ARE REALLY FOCUSING ON THERE BEING A SIGNIFICANT BURDEN OF CANCER CASES AND DEATHS, OR IF THAT'S NOT THE CASE, A RAPIDLY RISING BURDEN OF DISEASE OR DISPROPORTIONAL SHARE OF HEALTH RESOURCES FOR THAT SITE, WHICH IS THE CASE FOR CERVICAL, FOR EXAMPLE. AND THEN HAVING MODELING DATA FOR, YOU KNOW, DATA THAT COULD BE UTILIZED IN MODELING AS WELL AS COMMUNITY OF MODELERS. SO I THINK PROBABLY WITH THOSE CRITERIA THAT THAT EXPLAINS WHY THAT THERE ARE MORE ORGAN-BASED SITES BUT OTHERS FROM PROGRAM MAY BE ABLE TO ADJUST THAT BETTER. >> THIS IS DR. FOYER, PROGRAM COORDINATOR. MOST OF THE WORK HAS BEEN DONE OR BEGAN SITE SPECIFIC BECAUSE STUDYING THE NATURAL HISTORY OF DISEASE AND DATA SOURCES THAT ARE AVAILABLE, FOR EXAMPLE POLYP PREVALENCE AND THINGS LIKE THAT, ARE VERY CANCER-SITE SPECIFIC. WE HAVE ENCOURAGED GROUPS TO WORK CROSS CANCER SITES WHEN WE CAN SO FOR EXAMPLE WE'VE DEVELOPED LIFE TABLES AS A FUNCTION OF CO-MORBID DID COMORBIDITY OR BMI AND SMOKING THAT ARE USED ACROSS THE GROUP SO WE HAVE ENCOURAGED WORK ACROSS THE GROUPS WHERE POSSIBLE BUT THE CORE WORK HAS TO TAKE PLACE WITHIN EACH CANCER SITE. >> IN PARTICULAR, IF YOU'RE ADDING ANOTHER GROUP, WAS THERE A CONSIDERATION OF, SAY, AN HPV ASSOCIATED CANCERS AS OPPOSED TO CERVICAL CANCER, PER SE? >> WE CONSIDERED THOSE THINGS. WE THOUGHT WORKING ON A SPECIFIC CANCER SIT SITE IS REALLY A FOCUSED WAY TO GO. WE DO THINK THE WORK ON CERVICAL CANCER AND HPV VACCINATION AND IMMUNIZATION, HPV TESTING, WILL SPILL OVER TO HAVE BENEFITS FOR THE OTHER HPV-RELATED CANCERS, BUT I THINK WORKING ON A FOCUSED WAY ON ONE CANCER SITE WE FELT WAS A BETTER WAY TO GO AT THIS POINT. >> OKAY. OTHER QUESTIONS OR COMMENTS? >> THIS IS ELENA. I WANT TO ECHO THE COMMENT ABOUT ADDRESSING UNDERREPRESENTED GROUPS AND CANCER DISPARITIES BECAUSE I HAVE BEEN AT PRESENTATIONS FOR SOME GROUPS, WHEN I ASK THE QUESTIONS IT'S OBVIOUS THEY ARE NOT THERE YET. I REALLY WANT TO ENCOURAGE THAT. ISSUES THAT WERE BROUGHT UP, I WONDER IF THERE WAS DISCUSSION WORKING WITH THE GROUP, SOME OF THESE GROUPS ARE ADDRESSING THE SAME CANCERS, ALSO SOME GROUPS ARE ADDRESSING DISPARITIES. >> YES, SO DR. FOYER AGAIN. WE LISTED SIX OR SEVEN PRIORITY AREAS, AND ONE OF THEM IS UNDERSTANDING HOW SCREENING WORKS IN REAL WORLD SETTINGS AND DETERMINING THE BEST ROOTS NG WITH PROSPER, TRYING TO TO OPTIMIZE. HAVE A CLOSE COORDINATION WITH PROSPER, ADDING SOME CERVICAL CANCER SITES, SO WE'RE ENCOURAGED BY THAT AS WELL. >> THIS IS SHANITA. I HAD A QUESTION ABOUT FOR PROGRAMS ON -- I THINK IT'S GREAT YOU'VE ADDED -- SUGGESTING OPTIMAL ROUTES TO REDUCE HEALTH DISPARITIES AND I WONDER IF YOU COULD TALK ABOUT THOUGHTS ABOUT WHAT THAT WOULD ACTUALLY MEAN. >> YES, SO WHAT HAS BEEN IN MODELINGS, FOR EXAMPLE, WHAT CISNET HAS DONE IS TAKE RACE-SPECIFIC TREATMENT, SURVIVAL, INCIDENCE, MORTALITY AND TRIED TO DECOMPOSE AND APPLY, SAY, SURVIVAL THAT'S FOR WHITES TO BLACKS SO WE COULD SEE WHICH OF THE -- FOR SCREENING, TREATMENT, PREVENTION, WHAT ARE THE BIGGEST CORRECTORS TO HEALTH DISPARITIES. ALSO WE HAVE ONE OF THE PRIORITY AREAS THIS TIME IS IMPLEMENTATIONIMPLEMENT OF THE AFFORDABLE CARE ACT, HOPEFULLY ONE OF THE GREAT BENEFITS OF THE AFFORDABLE CARE ACT WILL BE REDUCING HEALTH DISPARITIES AND MODELING IMPACT AND UNDERSTANDING WHAT ARE THE CONTRIBUTORS TO THAT AS WE GO FORWARD. >> ONE OF THE QUESTIONS, A FOLLOW-UP QUESTION THEN, AS ITS OWN PRIORITY AREAS, IS THAT SOMETHING YOU WOULD REQUIRE APPLICANTS TO ADDRESS OR YOU WOULD SUGGEST THEY ADDRESS? HOW DO YOU SEE THAT PLAYING OUT IN TERMS OF PROPOSALS RECEIVED? >> IN GENERAL, THE PRIORITY AREAS, SO MANY PRIORITY AREAS THAT PEOPLE CAN'T ADDRESS, PEOPLE CAN'T ADDRESS ALL OF THEM IN THEIR APPLICATION. AS WE MENTIONED, WE ARE GOING TO ADD HEALTH DISPAR AS A PRIORITY AREA, AND I THINK WOULD VERY MUCH ENCOURAGE THEM TO INCLUDE THAT. WE JUST HAD SOME ADDITIONAL CONVERSATIONS WITH THE AMERICAN CANCER SOCIETY, AND THEY INDICATED THEY WOULD LIKE TO SEND SOME REPRESENTATIVES TO CISNET AND SOME OF THEIR HEALTHT IS PRIMARILY IN SET DISPARITIES, SO I THINK THAT WILL HELP PROMOTE THE AREA OF HEALTH DISPARITIES TO BECOME A CENTERPIECE OF SOME OF THE CISNET WORK. >> THIS IS KAREN. I THINK THAT'S TERRIFIC. [INAUDIBLE] I'D LIKE TO SEE THAT BASED HERE AS WELL. >> IS THERE ANOTHER COMMENT? >> I WAS WONDERING SO WHEN YOU DEVELOP THE MODELS THAT INCORPORATES VARIOUS THINGS, THE YOU HAVE OUTPUTS, THEY HAVE A SYSTEM TO VALIDATE THE MODELS IN TERMS OF WHETHER THEY CAN ACCURATELY PREDICT WHAT IT IS THAT YOU STRIVE TO GET. >> YES, SO WHAT WE DO IS, FOR EXAMPLE, CERTAIN TRIALS, WE CALIBRATED THE MODEL, DEVELOP BUILT THE MODEL WE TRY TO VALIDATE IT AGAINST OTHERS. THERE'S BEEN TRIALS OF FLEXIBLE SIGMOIDOSCOPY, AND THE GROUP WAS EXCITED BECAUSE IT REPRESENTED AN OPPORTUNITY TO VALIDATE THEIR MODEL BASED ON CALIBRATION THAT THEY DID ON OTHER TRIALS. SO THAT'S A REAL KEY TO CISNET MODELING, TO SEE IF WE COULD HIT GROUND TRUTH AND IF NOT CHANGE OUR MODELS, BUT IF SO IT GIVES US BETTER FEELING ABOUT THE CREDIBILITY OF THE MODELS AND HOW THEY HAVE BEEN DEVELOPED. >> OTHER COMMENTS? SOUNDS LIKE THERE'S A FAIR AMOUNT OF ENTHUSIASM. OKAY. KAREN, WOULD YOU MAKE A RECOMMENDATION? >> YES, I MOVE WE ACCEPT THE RECOMMENDATION TO REISSUE THE RFA AND TAKE THE RECOMMENDATIONS OF THE REVIEW INTO CONSIDERATION. >> IS THERE A SECOND? >> SECOND. >> ANY FURTHER DISCUSSION? OKAY. ALL OPPOSED? ANY ABSTENTIONS? OKAY. SOUNDS LIKE THE SUPPORT IS IN FAVOR OF REISSUANCE. OKAY. I THINK OUR OFFICIAL BUSINESS IS DONE. HAROLD, ANYTHING ELSE YOU WANT TO BRING TO THE BOARD? >> NOT AT THIS POINT. I WILL SEE YOU IN JUNE. >> SAY THAT AGAIN, HAROLD? >> I SAID NOT AT THIS POINT. I WILL SEE YOU IN JUNE. [INAUDIBLE] >> OKAY. THANK YOU, EVERYBODY. A SUCCESSFUL MEETING. MAYBE A B-MINUS ON THE TECHNOLOGY SIDE. >> YOU'RE A GENEROUS GRADER. >> A SUCCESS NONETHELESS. OKAY, WE'RE ADJOURNED. THANK YOU. >> THANK YOU.