>> WE WOULD LIKE TO WELCOME AGAIN THE MEMBERS OF BOTH THE BOARD OF SCIENTIFIC ADVISERS AND THE NATIONAL CANCER ADVISORY BOARD AND EX-OFFICIO MEMBERS, STAFF AND GUESTS. TODAY WE HAVE FOUR CONCEPT FOR THE BORED'S CONSIDERATION. BSA MEMBERS ARE REVIEWERS AND THE BSA WILL VOTE TO APPROVE, DISAPPROVE OR DEFER THE CONCEPT. BOTH NCAB AND BSA MEMBERS MAY PARTICIPATE IN THE DISCUSSION BUT ONLY BSA MEMBERS WILL VOTE. DURING THE VOTING, I WILL ASK HOW MANY MEMBERS DAYS PROVE, NON NON CONCUR AND ABSTAIN. WHEN ASKED, STATE YOUR NAME TO PAULETTE CAN COUNT AND RECORD THE VOTE. SO, WITHOUT FURTHER ADIEU, TODAY'S FIRST CONCEPT IS A NEW R.F.A. CO-OPERATIVE AGREEMENT PROPOSED INITIATIVE IMPLEMENTATION SCIENCE FOR CANCER CONTROL IN PEOPLE LIVING WITH HIV IN LOW AND MIDDLE INCOME COUNTRIES. Dr. VEDHAM IS GOING TO PRESENT AND THE SUBCOMMITTEE MEMBERS THAT REVIEWED THESE CONCEPT ARE CAROLE FARRENS, GAME LAC JIM LACY AND EILEEN WHITE. >> THANK YOU, EVERYONE. I'M PROGRAM DIRECTOR OF THE CENTER FOR GLOBAL HEALTH. I'M HERE TO PRESENT OUR CONCEPT TO SUPPORT IMPLEMENTATION SCIENCE FOR CANCER CONTROL AMONG PEOPLE LIVING WITH HIV AND LOWER MIDDLE INCOME COUNTRY. THIS CONCEPT WAS DEVELOPED BY CGH WITH INPUT FROM COLLEAGUES IN DCPPS, ALL HANDS AND DCP. AS OF 2019, 30 MILLION PEOPLE ARE LIVING WITH HIV WORLDWIDE. 36 MILLION INDIVIDUALS HAVE ACCESS TO ANTI-RETRO VILE PAL. 90% OF POSITIVE INDIVIDUALS RESIDE IN LOW AND MIDDLE INCOME COUNTRIES. IN LMICs, HIV INFECTION IS A MANAGEABLE CHRONIC HEALTH CENTER DUE TO INCREASED ACCESS TO A. R.T. AND SERVE DELIVERIES SUCH AS COMMUNITY BASED MODELS OF CARE, AND HAVE LED TO INCREASED LIFESPAN AMONG PEOPLE LIVING WITH HIV. HOWEVER, THIS AGING HIV POPULATION IN LMICs IS NOW EXPERIENCING INCREASED CANCER RELATED MORBIDITY AND MORTALITY. ALE TOALTHOUGH THERE'S EVIDENCE BASED CANCER FOR HIV POSITIVE INDIVIDUALS, IN COUNTRY, THEY'RE UNREALIZED OPPORTUNITIES FOR TRANSLATING THIS EVIDENCE TO BENEFIT HIV POPULATION. LEVERAGING AND BUILDING ON COMMUNITY INFRASTRUCTURE AND TO PROMOTE EVIDENCE BASED CANCER CONTROL INTERVENTIONS AND OUR EVIDENCE-BASED CANCER CONTROL INTERVENTIONS INTO HIV TREATMENT PROGRAMS THAT ENGAGE REMOTE AND VULNERABLE COMMUNITIES AND DEVELOPING AND ADAPTING IN TELEMEDICINE AND TO IMPROVE THE UPDATE AND REACH OF EVIDENCE BASED CONTROL INTERVENTIONS IN PEOPLE LIVING WITH HIV. THAT INCREASE THE SUSTAINABILITY OF EVIDENCE-BASED INTERVENTIONS INTO PRACTICE. IMPLEMENTATION SCIENCE IS THE STUDY OF STRATEGIES TO PROMOTE THE ADOPTION AND INTEGRATION OF EVIDENCE-BASED INTERVENTIONS IN A VARIETY OF SETTINGS TO IMPROVE THE IMPACT AND POPULATION HEALTH. BUT INTERVENTIONS MAY MEAN PROGRAMS, PRACTICES OF POLICIES, THAT HAVE BEEN DEMONSTRATED TO IMPROVE HEALTH. BY STRATEGIES, THEY MEAN METHODS AND ENHANCING THE ADOPTION AND INCOMPETENT INAUGURATION, SUSTAINABILITY OF THESE PROVEN INTERVENTIONS. IN 2000, THEY ESTIMATED THAT THE FOCUS OF IMPLEMENTATION STRATEGIES, IT TAKES 17 YEARS FOR ONLY 14% OF ORIGINAL RESEARCH FINDINGS TO REACH PATIENTS. THIS ANALYSIS WAS FROM HIGH INCOME COUNTRIES AND THE INTERVAL IS IN THE LONGER AND LOWER IN LMICs SO IT'S A CRITICAL TOOL FOR ACHIEVING GLOBAL CANCER CONTROL. DESPITE ITS IMPORTANCE FOR BRIDGING TO EVIDENCE GAPS, IMPLEMENTATION SIGNS IN LMCIs IS UNDER REPRESENTED IN THE CURRENT NCI PORTFOLIO, ESPECIALLY FOR HIV INFECTED INDIVIDUALS. THE GOAL OF THIS RFA IS TO SUPPORT THE ADAPTATION AND TESTING OF IMPLEMENTATION STRATEGIES TO DELIVER EVIDENCE-BASED INTERVENTIONS TOOLS AND TECHNOLOGIES FOR CANCER CONTROL AMONG PEOPLE LIVING WITH HIV IN LMICs. THIS CONCEPT WAS APPROVED FOR IN CONCLUSION IN THE NIH OFFICE OF AIDS RESEARCH AND FY-22 BUDGET TO ADDRESS MULTIPLE NIH PRIORITIES FOR AN HIV INCLUDING THE CURRENT OAR STRATEGIC PLAN GOAL TO PROMOTE THE DES SEM NATION AND IMPLICATION OF RESEARCH DISCOVERIES FOR PUBLIC-HEALTH IMPACT GLOBALLY. WE'RE REQUESTING A MECHANISM TO STIMULATE HIGH-QUALITY APPLICATIONS AND TO SUPPORT A HOE COURCOHORT OF AGREEMENT PROJECTS IN THIS PRIORITY RESEARCH AREA. HERE ARE SOME EXAMPLES OF RESEARCH WE ANTICIPATE FROM. STUDY TO DESIGN, DEVELOP AND TEST THEORY IN FARM IMPLEMENTATION STRATEGIES TO IMPROVE UPTAKE AND INTEGRATION OF EVIDENCE-BASED CANCER CONTROL INTERVENTIONS FOR PEOPLE LIVING WITH HIV, STUDIES THE VALUE COMPARATIVE EFFECTIVENESS AND COST EFFECTIVENESS OF DIFFERENT IMPLEMENTATION STRATEGIES AND STUDIES OF POLICIES AND OTHER CONTEXTUAL FACTORS THAT IN TERMS OF SUCCESS OF DES SIM NATION AND STUDIES THAT EXPLORE STRATEGIES FOR TELEHEALTH AND TELEMEDICINE INTERVENTIONS TO DELIVER EVIDENCE BASED CANCER CONTROL IN STUDIES TO UNDERSTAND HOW AND WHY IMPLEMENTATION EFFORTS ARE SUCCESSFUL OR UNSUCCESSFUL IN HIV POPULATIONS IN LMICs. NEXT SLIDE, PLEASE. BASED ON OUR DISCUSSION WITH THE BSE REVIEW SUBCOMMITTEE, WE HAVE MADE SUBSTANTIAL MODIFICATIONS TO THE RFA THAT WILL BE REFLECTED IN THE FUNDING OPPORTUNITY ANNOUNCEMENT. WE HAVE ADDITIONAL REQUIREMENTS FOR APPLICANTS SUCH AS APPLICANTS MUST DELIVER THE LMIC ENVIRONMENT AND HOW THE PROJECT ADDRESSES LOCAL CANCER CONTROL PRIORITIES AND PROVIDE PRELIMINARY DATA REGARDING THE EFFICACY OF THE INTERVENTIONS TO BE IMPLEMENTED, INCLUDES PLANS FOR FEASIBILITY AND ACCEPTABILITY OF THE INTERVENTION AND DESCRIBE FOR POTENTIAL TO BE SCALED UP AND SUSTAINED AND THEY MUST DEMONSTRATE A TRACK RECORD OF LONG-TERM PARTNERSHIPS WITH THE LMIC INSTITUTIONS AND THE DIVERSE LMIC STAKEHOLDERS. THEY ALSO ADDED THE FOLLOWING EXCLUSION CRITERIA FOR NONRESPONSE I HAVE PROJECTS, PROJECTS THAT DEVELOP AND TEST INTERVENTIONS, NEW INTERVENTIONS OR UTILIZE INTERVENTIONS WITH NO INITIAL PROOF OF CONCEPT. PROJECTS THAT ABSENCE OF KEY PERSONNEL UNTIL LM. >> Catherine: s, PROJECTICs OF THEIMPLEMEN TATION STRATEGIES. AND IN ADDITION THROUGH THE U1 MECHANISM, THEY FACILITATE APPROPRIATE FOR COLLABORATIONS INCLUDING, SHARING OF METHODS AND SAMPLES AND DATA WITH OTHER RELEVANT HIV OR IMPLEMENTATION SIGNS NETWORKS AT NCI ORB NIH. NCI WILL FACILITATE TRAINING FOR RESEARCHERS WHEN NEEDED AND THE NEXT SLIDE, PLEASE. THEY WILL BE ASKED TO REFLECT THE CHANGES MENTIONED EARLIER. DOES THE PROJECT ADEQUATELY ACCOUNT FOR CHARACTERISTICS OF THE LOCAL HEALTH SYSTEM AND IS A PROPOSED IMPLEMENTATION APPROACH APPROPRIATE FOR THE PROBLEM AND THE POPULATION PROPOSED AND THE RESEARCH METHODS RELEVANT AND PRACTICAL IN THE CONTEXT OF LMCI SETTINGS AND DOES THE PROPOSAL DEMONSTRATE RELEVANT COMMUNITIEN ENGAGEMENT INCLUDING EQUITABLE PARTNERSHIPS OPPORTUNITIES FOR RESEARCH, COMMUNITY AND A CLEARLY POTENTIAL FOR SCALABILITY AND SUSTAINABILITY AND AS THE PROJECT INCLUDED ADEQUATE TRAINING WITH LMIC INSTITUTIONS, INVESTIGATORS AND STAKEHOLDERS. IN SUMMARY, I HAVE DEMONSTRATED REMARKABLE GAINS IN HIV, THOUGHT CONTROL HAVE CREATED IMPORTANT CANCER CONTROL OPPORTUNITIES AMONG PEOPLE LIVING WITH HIV AND RECEIVING A. R.T. WHO ARE EXPERIENCING AN INCREASING CANCER BURDEN IN LMICs AND IMPLEMENTATION SCIENCE IS A PRIORITY RESEARCH AREA FOR THE NCI AND NIH STRATEGIC PLAN FOR HIV AND HIV-RELATED RYE SEARCH. HOWEVER, IMPLEMENTATION SCIENCE IS UNDER REPRESENTED IN THE CURRENT NCI GLOBAL AND 46th HIV PORTFOLIOS. INCREASING SUPPORT FOR IMPLEMENTATIONS SCIENCE AS A DISCIPLINE AND COMMUNITY IN LMICs CAN LIKELY ADDRESS CRITICAL EVIDENCE TO PRACTICE GAPS AND COMPLIMENT EXISTING HIV-RELATED PROGRAMS AT NIH AND NCI. THIS SUPPORTS PROJECTS TAIL ORDER TO THE DIVERSE CANCEL CONTROL NEEDS OF PEOPLE LIVING WITH HIV BY CARE DELIVERY IN LMICs. WITH THAT I THANK YOU FOR THE OPPORTUNITY AND I WOULD BE HAPPY TO TAKE QUESTIONS. THANK YOU. >> THANK YOU, VERY MUCH. IT WAS A VERY CLEAR PRESENTATION AND I WILL TURN IT OVER TO CAROLE, WHO CHAIRED THE REVIEW COMMITTEE. >> THANK YOU. SO, WE HAD A REALLY VERY ENGAGING DIALOGUE WITH Dr. VEDHAM AND SHE WAS EXTREMELY RESPONSIVE. OUR REVIEW GROUP WAS ENTHUSIASTIC ABOUT THE CONCEPT, OBVIOUSLY. THERE'S A NEED FOR IMPLEMENTATION SCIENCE AND CANCER CONTROL AND PEOPLE LIVING WITH HIV IN LOW AND MIDDLE INCOME COUNTRY. IS THE CONCEPT WAS WELL WRITTEN. THE COST OF THE ENTIRE PROJECT IS $25 MILLION, IT CAME TO US WITH APPROVAL ALREADY FOR USE OF AIDS FUNDING FROM OAR. AND SO, OUR CONCERNS OR CONTRIBUTIONS TO THIS WAS ALONG THE LINES OF THE ENTIRE DOCUMENT WAS FRAMED IN A VERY BROAD, ALL-INCLUSIVE MANNER AND WE WERE CONCERNED THAT ADDITIONAL INFORMATION BE PROVIDED AS WELL AS CRITERIA IN ORDER TO ENSURE THE SUCCESS OF THIS. SO, OUR COMMENTS WERE LISTED, OUR COMMENTS WERE RESPONDED TO VERY NICELY BY Dr. VEDHAM AND IT WAS LISTED FOR YOU IN THOSE TWO SLIDES. YOU SAW THOSE. THEY WERE CONCERNING THE REVIEW CRITERIA THAT THERE WOULD BE MORE FIRM REVIEW CRITERIA FOR THIS. THE EFFORTS THAT WERE SELECTED WOULD BE ABLE TO BE SCALED UP AND THAT THERE WOULD BE REQUIREMENTS FOR PARTNERSHIP AND TAKES HOLDERS, DISSEMINATION, ALL TO ENSURE THE SUCCESS OF THESE EFFORTS AND SO THIS MONEY WOULDN'T BE WASTED. WE ENCOURAGED EVENTS ON TRAINING AND DES SEM NATION FOR THIS AND THOSE WERE OUTLINED FOR YOU NICELY AND THOSE TWO SLIDES SO I DON'T THINK I HAVE TO GO INTO A LOT OF DETAIL. THEY WERE ALL RESPONDED TO AND I PERSONALLY WAS VERY PLEASED WITH Dr. VEDHAM'S RESPONSE. I'D LIKE TO OPEN IT UP TO JIM LACY AND EILEEN WHITE, WHO WERE ALSO ON THE REVIEW COMMITTEE. >> SO, CAROLE, SUMMARIZED EVERYTHING QUITE THOROUGHLY SO I HAVE NOTHING TO ADD. >> JUST ONE MINOR COMMENT, IF I MAY. OVER THE LAST COUPLE OF YEARS, WE'VE SEEN A NUMBER OF THESE PROPOSALS FOCUSING WITH SOUND SCIENTIFIC RATIONALE ON RESEARCH AND LMICs AND THERE'S BEEN EFFORTS ON CLINICAL TRIALS AND INCREASING THE ROLE OF TECHNOLOGY AND TO MAKE ONE JUST FOLLOW-UP POINT ABOUT THE REVIEW CRITERIA, NCI IS IN A GREAT POSITION TO LEVERAGE SUCCESSES AND LESSONS LEARNED ACROSS THOSE MULTIPLE INITIATIVES. I WOULD URGE PROGRAM TO LOOK AT THE BOARD AT NCGH IS WHAT IS WORKING ON THESE INITIATIVES FOCUSED CORRECTLY, AS WE ALL AGREE, BOOSTING BOTH RESEARCH AND INFRASTRUCTURE AND OPPORTUNITIES IN LMICs AND AS CAROLE MENTIONED, THIS CONCEPT, THE NUMBER OF STEPS IN THAT DIRECTION I REALLY URGE THE NCI TO KEEP AN EYE ON THAT SO THEY CAN MANAGE IT AS MUCH AS THEY CAN. THANK YOU. THERE'S A COMMENT FROM KEVIN. KENT, DO YOKENT, DO YOUKEVIN, DO YOU WANT TO ADD SOMETHING? >> I HAVE A COMMENT JUST LEADING THE BOARD. >> ALL RIGHT. THAT'S OK. ANY COMMENTS, ADDITIONAL COMMENTS FROM THE PANEL? >> JUST A POINT OF CLARIFICATION FOR THE REVIEW CRY TEIA, IN TERMS OF THE PRELIMINARY DATA ON THE INTERVENTIONS BEING PROPOSED, CAN YOU CLARIFY IS THAT DATA IN LMICs OR JUST DATA ON THE INTERVENTION IN SOME OF THE POPULATION THAT WOULD BE CONSIDERED APPROPRIATE FOR A PROPOSAL? >> IDEALLY WE WOULD LIKE DATA FROM LMICs. THAT BEING SAID, WE UNDERSTAND THAT THERE'S A NEED TO TEST INTERVENTIONS THAT HAVE BEEN DONE IN HIGH-INCOME SETTINGS OR OTHER SETTINGS THAT CAN BE EXPLORED OR ADAPTED TO LOW INCOME SETTINGS. WE DO ANCHORAGE TO SEE SOME DATA FROM THE LOW INCOME AT TH SETTINGS FOR THE SETTINGS. >> THAT'S GOOD. I ENCOURAGE YOU HAVING IT OPEN. BECAUSE THERE ARE SOME INTERVENTIONS THAT PROBABLY DON'T REQUIRE THAT ADDITIONAL STEP OF PRELIMINARY DATA FROM AN LMIC THAT COULD HAVE A TERRIFIC IMPACT SO I LIKE THE IDEA THAT IT CAN BE EITHER DIRECTION. THANK YOU. >> ANY ADDITION AT COMMENTS AND WE'LL MOVE TO THE VOTING. I SEE NONE. IS SO, I WOULD LIKE TO ASK FOR A MOTION. >> I'LL MOVE TO APPROVE. >> SECOND. >> >> I'LL SECOND THAT. >> ANY OTHER DISCUSSION POINTS? >> IF NONE, I WILL ASK HOW MANY OF YOU DISAPPROVE? ANY ABSTENTIONS? MOTION CARRIES UNANIMOUSLY. SO WE WILL MOVE NOW TO THE NEXT CONCEPT WHICH IS A NEW RFA AND MULTI-LEVEL APPROACH TO CONNECTING UNDER REPRESENTED POPULATIONS TO CLINICAL TRIALS AND Dr. BAILEY WILL PRESENT AND THE SUBCOMMITTEE MEMBERS THAT REVIEW THESE ARE OTIS BRAWLLY AND KEN AND CHERYL WILLIAMS SO, LEHAMN, THE FLOOR IS YOURS. >> THANK YOU. GOOD AFTERNOON, EVERYONE. AND THANK YOU FOR THE OPPORTUNITY TO PRESENT CONNECTING UNDER REPRESENTED POPULATIONS TO CLINICAL TRIALS. NIH AND MCI LEADERSHIP ARE COMMITTED TO ACTIONABLE CHANGE WITH REGARD TO STRUCTURAL RISK RACISM AND DISPARITIES AND IT'S PARTICULARLY TIMELY IN LIGHT OF FINDINGS IN THE SIGNING OF A WHITE HOUSE EXECUTIVE ORDER THAT FOCUSES ON DISPARITIES AND THIS WAS FURTHER REINFORCED BY Dr. JOE BIDEN RECENT VISIT TO NCI AS WELL AS A TRIP TO MASSEY CANCER CENTER. THE INNOVATION IS ITS FOCUS ON ADVANCING OUTREACH AND EDUCATION INTERVENTIONS THAT TARGET NOT ONLY UNDER REPRESENTED MINORITY POPULATIONS BUT REFERRING PHYSICIANS THROUGH A COLLABORATIVE TEAM EFFORT USING COMMUNITY HEALTH EDUCATORS AND LAY HEALTH ADVISERS. THE PURPOSE OF THE PROGRAM IS TO EVALUATE MULTI LEVEL AND CULTURALLY TAILORED OUTREACH AND EDUCATION INTERVENTIONS WITH THE PRIMARY GOAL OF INCREASING REFER ALF POPULATION TO NCI SUPPORTED CLINICAL TRIALS. NEXT SLIDE, PLEASE. THE UNDER REPRESENTED RACIAL ETHNIC POPULATIONS OF INTEREST ARE SHOWN HERE AND THERE ARE CERTAINLY OTHER DISPARITIES POPULATIONS BUT WE'RE FOCUSED ON THESE POPULATIONS FOR THIS PROGRAM INITIALLY. AND SO, NCI CLINICAL TRIALS HAS IMPROVED AS DEMONSTRATED BY THESE DATA AND THEY ARE NOTED IN RACIAL AND ETHNIC MINORITY POPULATIONS TO THE NATIONAL CLINICAL TRIAL NETWORK AND NCI COMMUNITY ONCOLOGY RESEARCH PROGRAM. THE DATA CAPTURE DEPICTS THE CLINICAL TRIALS FROM 1999 TO 2019 AS ONE CAN SEE, THE CURRENT NUMBER ARE STILL SUBSTANTIALLY BELOW THE RACIAL AND ETHNIC MAKE UP OF THE GENERAL U.S. POPULATION THE ASPIRATION IS THE CLINICAL TRIAL COHORTS WOULD PROVIDE A REP REPRESENTATION OF THE U.S. POPULATION SO THERE IS A NEED TIME PROVE. A PORTFOLIO ANALYSIS WAS CONDUCTED TO IDENTIFY NCI FUNDED GRANTS, FOCUSED ON CLINICAL TRIALS AND UNDER REPRESENTED POPULATIONS AWARDED BETWEEN THE YEARS OF 2010 AND 2019. THE DATA INDICATE THERE'S A CRITICAL NEED FOR RESEARCH AS TO THE EFFECTIVENESS OF OUTREACH, EDUCATION AND REFERRAL IN INCREASING UNDER REPRESENTED MINORITY PARTICIPATION IN CLINICAL TRIALS. SEVERAL POTENTIAL WAYS EXIST AND MANY APPROACHES ARE IN PLAY AND REFLECTED THROUGH THE EFFORTS OF THE NCI CLINICAL TRIAL PROGRAM. APPROACHED INCLUDE INCREASED TRIAL FOR PARTNERSHIPS BETWEEN MAJOR CANCER CENTER AND SATELLITE HOSPITALS AND ALTERNATIVELY, PATIENTS CAN BE ENROLLED A LOT THEIR LOCAL HOSPITAL AND UNDERGO TREATMENT THERE AND IT CAN BE SET TO THE CANCER CENTER AND TARGETED INTERVENTIONS SUCH AS SPANISH INTERPRETERS, HAVE BEEN USED TO HELP ENROLL UNDER REPRESENTED PATIENTS IN CLINICAL TRIALS AND THERE'S AN OPPORTUNITY TIME PROVE STANDARDIZE EFFORTS ACROSS PROGRAMS. THE GOAL IS TO PRODUCE LEVERAGE INCREASE CLINICAL TRIAL RESEARCH PARTICIPATION, THAT IS SUPERIOR AND COMPARES TO INDIVIDUALS SILOED EFFORTS. THERE ARE THROW LEVELS OF BARRIERS THAT PREVENT THE RACIAL AND ETHNIC MINORITY POPULATIONS IN CLINICAL TRIALS AT THE PATIENT PROVIDER AND SITE LEVEL. PROPOSING THE USE OF LAY HEALTH AT VICARS AND COMMUNITY HEALTH EDUCATORS BASED ON THEIR EFFECTIVE ABILITY TO SERVE AS LIAISONS BETWEEN THE COMMUNITY AND HEALTHCARE PROVIDERS WITH THE FEATURES OF BEING IN AN INTEGRATE AND COORDINATED TEAM AND THE ADOPTION FOR TURLEYLY TO ADDRESS THE BARRIERS AT DIFFERENT LEVELS. NEXT SLIDE, PLEASE. THE PERCEPTION EXIST THAT CLINICAL TRIAL REFERRAL IS STRAIGHT FORWARD BUT IT'S ANYTHING BUT. A FEW OF THE REFERRAL CHARGES ARE OUTLINED HERE AND THEY'RE NOT NEW. IT WILL FOCUS ON INTERCEPTIONS THROUGHOUT THE REFERRAL PROCESS DELIVERED BY THE LAY HEALTH ADVISERS AND INTEGRATED TEAM TO ADDRESS ITEMS LIKE IMPLICIT BIAS, LANGUAGE OR LITERACY BEARERS AS WELL AS ADDITIONAL ACCESS PROBLEMS. IF THERE ARE REFERRAL PROGRAMS AND PARTICIPANTS WHO NEED THEM, BUT THE SERVICES ARE DISCONNECTED, THEY'RE NOT AS EFFECTIVE. SO THE BOTTOM LINE IS, IS THAT IF RACIAL AND ETHNIC MINORITY POPULATIONS ARE NOT ENGAGE IN EDUCATED ABOUT THE CLINICAL TRIALS, THEY WON'T PARTICIPATE. CT IS PROVIDING EDUCATION AND OUTREACH TO THE COMMUNITIES AS WELL AS THE REFERRAL CARE PROVIDERS INCREASING CLINICAL TRIAL AWARENESS OVER ALL, AND IMPLEMENTING THESE INTERVENTIONS TO ADDRESS BARRIERS. THEY WILL USE THE PROPOSED INTERVENTIONS TO TALK ABOUT ACTIVE TRIALS AND ALL INTEGRATED TEAM MEMBERS WILL PLAY VITAL ROLES IN INCREASING DIVERSITY AND PROVIDING COORDINATED CARE. THE PROGRAM WILL REQUIRE INTEGRATED APPROACHES AND MANAGEMENT. ALTHOUGH CUSP2CT'S MAIN GOAL IS THE REFER ALF PARTICIPANTS TO CLINICAL TRIALS, IT IS EXPECTED THAT DOWNSTREAM EFFECTS WILL INCLUDE THE INCREASED RECRUITMENT AND ENROLLMENT AND RETENTION. THE CUSP2CT NETWORK WILL HAVE FOUR GRANTEE SITES. U01 WITH INTERVENTIONS TO EDUCATE AND REFER THE POPULATIONS ABOUT THE TRIAL AND TO INCREASE THE AWARENESS. A DATA EVALUATION AND COORDINATE CENTERING WILL BE RESPONSIBLE FOR MONITORING REFERRAL RATES, SUCCESSFUL IMPLEMENTATION OF INTERVENTION AND DATA COLLECTION EFFORTS INCLUDING BEST PRACTICES, DES SEM NATION AND OVER ALL PROGRESS. THE COORDINATING CENTER AND THE INDIVIDUAL U01s CAN FORM A LEARNING COLLABORATIVE WHERE THEY CAN IDENTIFY COMMON METRICS, GATHER DATA, AND EXAMINE THE DATA TOWARDS REFINING THE STRATEGIES BEING TESTED. WORKING TO SCALE UP THE ONES THAT ARE MORE EFFECTIVE OR SHUTTING AWAY FROM THOSE NOT AS SUCCESSFUL. A FEW AREAS OF RESEARCH INTEREST ARE DETAILED HERE AND WE ARE INTERESTED IN A VARIETY OF TOPICS. INCLUDING RESEARCH TO ADDRESS IMPLICIT BIAS AND STRENGTHEN THE COMMUNICATION SKILLS OF PRIMARY CARE AND REFERRAL PROVIDERS SO THAT THEY'RE MORE OPEN AND PREPARED TO EFFECTIVELY DISCUSS TRIALS WITH PATIENTS. THE DEVELOPMENT OF REFERRAL PATHWAYS TO CLINICAL TRIALS THAT WOULD REQUIRE MINIMAL RESOURCE INVESTMENTS ON THE PART OF THE HEALTHCARE ORGANIZATIONS AND INCLUDING LINKAGES TO COMMUNITY BASED RESOURCES THAT CAN EASE THE REFERRAL ON PROVIDERS AND THEIR STAFF, IS ALSO OF KEEN INTEREST. THE EXPECTATION IS APPLICANTS WILL LEVERAGE THEIR CURRENT PARTNERSHIPS AND INFRASTRUCTURE DEVELOPING NEW ONES IN TANDEM WITH THE HEALTH ADVISERS IN THE INCOMPETENT GREATED TEAINTEGRATED TEAM. WORKING TOGETHER, THE SITES WILL ADDRESS BARRIERS, PURSUE SUSTAINABILITY, AS WELL AS LEVERAGE FACILITATORS. ELEMENTS FOR CONSIDERATION ARE LISTED HERE. AND INCLUDE THE TYPE OF SETTING, COMMUNITY OF FOCUS, THE COMPOSITION OF THE INTEGRATED PERSONAL TEAMS AS WELL AS THE PROPOSED INTERVENTIONS. SUSTAINABILITY WILL ALSO BE CRITICALLY IMPORTANT AND THE EXPECTATION IS THAT THE SITES WILL LEVERAGE EXISTING RESOURCES, STAFF, AND RELATIONSHIPS TO ENSURE PERPETUITY. THE APPLICATIONS ALSO REPRESENT AN OPPORTUNITY FOR THE COMMUNITIES TO PRIORITIZE THE CLINICAL TRIALS OF INTEREST, SUCH AS AFRICAN AMERICAN FEMALES AND TRIPLE NEGATIVE BREAST CANCER. THE DATA EVALUATION AND COORDINATING CENTER WILL SUPPORTIVE TEASE INCLUDING THE RECEIPT, STORAGE AND ANALIZATION OF DATA FROM THE GRANDE SITES. THE DATA COLLECTED BY THIS U 4:00 WILL SUPPLEMENT AND ALREADY BEING COLLECTED THROUGH THE NETWORK OF CENTRALIZED OPERATIONS. NEXT SLIDE, PLEASE. FOR THE PURPOSES OF TODAY, I WON'T GO THROUGH ALL THE MET TRACKS BUMETRICSBUT HERE IS A SNAPSHOT OF HOW WE ADDRESS SUCCESS MEASURES. WE REALLY DO WANT TO BE ABLE TO TELL S. THIS PROGRAM WORKING? IS THIS AUGMENTING, EXTENDING THE REACH AND ARE THE INTERVENTIONS WORKING? THIS IS THE BUDGET THAT WAS APPROVED BY THE NCI SPECIAL PROGRAM LEADERS. THERE'S BEEN RICH DISCUSSION WITH MANY GROUPS REGARDING THESE ALLOCATIONS AND THIS INCLUDES SOME INSIGHTFUL COMMENTS AND SUGGESTIONS BY OUR BSA REVIEWERSMENT THE TOTAL AIM WILL COST FOR THE 4 10:0 AWARDS ARE $3.6 MILLION AND THE TOTAL COST FOR A FIVE-YEAR PROJECT PERIOD ARE $18.2 MILLION. IN SUMMARY, THE IMPLEMENTATION OF CUSP2CT WILL UNDERTAKE THE PARALLEL DELIVERY OF COMMUNITY OUTREACH AND EDUCATION BY COMMUNITY HEALTH EDUCATORS AND LAY HEALTH AT VICORS, STRATEGIC ENGAGEMENT WITH PROVIDERS, AND SUPPORT SERVICES ADDS NEED TODAY PRODUCING INCREASE CLINICAL RESEARCH ENGAGEMENT THAT IS SUPERIOR IN COMPARISON TO INDIVIDUAL SILO EFFORTS. IN THE WORDS OF THE REPRESENTATIVE ELI SHA CUMMINGS, MANY OF THESE AMERICANS STRUGGLING TO SURVIVE ARE AMERICANS OF COLOR. THEIR ASSISTANCE CAN FRONT AMERICA WITH A TEST OF OUR MORAL COMPASS AS A NATION AND IN SHORT, WE HAVE TO DO BETTER AND WE HAVE TO DO IT TOGETHER. A CONCEPT SUCH AS THIS REQUIRES A COLLABORATIVE MULTI DISCIPLINARY TEAM AND THE WORKING GROUP FOR THIS CONCEPT REPRESENTS A TRANS NIH AND NCI COMPOSITION. I'D LIKE TO THANK THEM FOR BEING SO GENEROUS WITH OUR TIME, TALENT AND EXPERTISE. A SPECIAL THANK YOU GOES TO THE CRCHD LEADERSHIP AND CONCEPT TEAM FOR THEIR PATIENTS, PERSEVERANCE AND SUPPORT. AND LASTLY WE'D LIKE TO THANK THE BSA REVIEWER FOR THEIR THOROUGH REVIEW AND THOUGHTFUL FEEDBACK. AND WITH THAT, I'D LIKE TO THANK YOU FOR YOUR TIME AND ATTENTION AND WE WOULD BE HAPPY TO ANSWER ANY QUESTIONS. >> THANK YOU, LEANNE. GREAT PRESENTATION. OBVIOUSLY ON A VERY, VERY IMPORTANT TOPIC. SO, I WILL TURN IT OVER NOW TO THE SUBCOMMITTEE. WHY DUE START US OFF. >> THANK YOU. I'D LIKE TO THANK Dr. BAILEY FOR A WONDERFUL PRESENTATION AND RESPONDING VERY MUCH TO OUR CONCERNS. Dr. WALDMAN AND I REVIEWED THE PRESENTATION, THE ORIGINAL PRESENTATION. WE WERE VERY ENTHUSIASTIC OF THE IDEA AND THE CONCEPT. THE ONE CRITICISM WAS THAT THIS IS NOT BEING DONE ENOUGH AND ENOUGH MONEY IS NOT BEING PUT NO THESE TYPES OF PROBLEMS AND WE UNDERSTAND THE PROBLEMS THAT NED AND THE NCI FACE AND SO WEREN'T BEING TOO HARSH ON THE NCI FOR THAT. ONE THING I WILL POINT OUT, THERE'S A WONDERFUL SLIDE THAT TALKS ABOUT THE 11% OF BLACKS WHO ARE ON NCI CLINICAL TRIALS. THIS IS ACTUALLY SOMETHING I THINK THE NCI CAN BE VERY PROUD OF. WHILE IT'S 13% OF THE AMERICAN POPULATION IS BLACK, IT'S 11.2% OF THE AMERICAN POPULATION WITH CANCER THAT IS BLACK. SO, YOU ARE 11% IS VERY CLOSE TO 11.2%, VERY CLOSE TO PROPORTIONAL AND THERE'S BEEN A TREND UPWARDS OVER THE LAST SO YEARS OR SO FROM THE NCI. INDUSTRY TRIALS ARE NOT AS REPRESENTATIVE OF MINORITIES. EVEN NCI TRIALS HAVE DISPARITIES WHEN WE TALK ABOUT ASIANS AND OTHER GROUPS. THERE'S A SHORTAGE OF PEOPLE GOING ON THE CANCER TRIALS, PERIOD. THE BIG SHORTAGE IS ONLY 3% TO 5% OF PEOPLE WITH CANCER GOING ON TO A CLINICAL TRIAL, PERIOD. THERE'S A LOT OF TALK ABOUT RACE AND INCLUSION. ONE OF THE THINGS I WORRY ABOUT IS THAT PEOPLE DON'T REALLY UNDERSTAND WHY RACE AND INCLUSION IS IMPORTANT. THERE'S A LOT OF FOLKS WHO SEE SUBSTANTIVE ANALYSIS AMONG THE VARIOUS RACES IS IMPORTANT. THAT'S ACTUALLY AN INCREDIBLE OVER SIMPLIFICATION OF THE NEED FOR MINORITIES. IN ANY EVENT, I THOUGHT THAT WE REALLY LIKE THIS AND WE WISH WE COULD DO MORE OF STUFF LIKE THIS. WE WISH THAT EACH INDIVIDUAL GRANT COULD HAVE MORE MONEY AND THAT THERE COULD BE MORE GRANTS LIKE THIS AND I WILL YIELD TO MY COLLEAGUES. >> GREAT, I'LL JUMP IN. I DON'T HAVE A LOT TO ADD. THE ONE THING THAT I WILL ADD IS THAT ONE OF THE REASONS THAT WE WOULD LIKE TO ENCOURAGE THIS TO BE BIGGER IS THAT WITH FOUR CENTERS, THE IDEAS THAT THEY COORDINATE AND LEARN FROM EACH OTHER AND URBAN CENTER WILL BE VERY DIFFERENT THAN A RURAL CENTER THAN A CENTER THAT IS MORE IN THE SOUTHWEST OR THE SOUTH -- >> SO THANK YOU, Dr. BAILEY. YOU DO A FANTASTIC PRESENTATION AND YOU ARE DOING PHENOMENAL WORK. I THINK THIS IS A TREMENDOUS INITIATIVE AND WE DID SOME TOYING AROUND SO I'D LIKE TO MAKE A FEW SUGGESTIONS TO Dr. SHARPLESS. THEEL CHALLENGE WITH THIS PROPOSAL IS JUST NOT ENOUGH MONEY TO HAVE THE IMPACT THAT WE WOULD ALL LIKE THIS TO HAVE. FUNDING FOR INSTITUTIONS IS FAR TOO FEW. WE HAD AN IDEA THAT MIGHT NOT COST YOU A LOT OF MONEY. I THINK YOU ARE GOING TO HAVE A TON OF APPLICANTS TO THIS. I THINK EVERY NCI CANCER CENTER IS LIKELY TO RESPOND, PARTICULARLY THOSE THAT HAVE CLINICAL TRIALS NETWORKS, OR COLLABORATIONS WITH COMMUNITY HOSPITALS AND COPS OR MINORITIES SITES THAT HAVE ESTABLISHED NETWORKS AND USE THEIR OWN INSTITUTIONAL FUNDS NOW TO TAKE COMMUNITY OUTREACH AND ENGAGEMENT AND OTHER CLINICAL TRIALS STAFF TO TRY TO DO THESE THINGS AND WE ALL LOVE THE IDEA OF THIS LEARNING COLLABORATIVE WHERE THERE'S REAL SHARING. ONE OF THE THOUGHTS WE HAD, NED, IS THIS WAS PROPOSAL WAS TO FUND AND Dr. BAILEY, WAS TO FUND FOUR GRANTS OF $450,000. IF YOU ACTUALLY TOOK THE SAME AMOUNT OF MONEY, YOU COULD FUND SIX GRANTS AT $300,000 A YEAR. MOST CANCER CENTERS AND OTHER INSTITUTIONS ARE INTO THIS BALL GAME, YOU GOING TO PUT UP MATCHING MONEY AND SO ONE SIMPLE THING IS WE THOUGHT YOU CAN DO SIX GRANTS RATHER THAN $450 THAT $150,000 IS A GOING TO MAKE A BREAK AN APPLICATION AND PLAYING WITH A PATH FOR A LITTLE MORE FOR JUST A MILLION DOLLARS MORE A YEAR YOU COULD FUND EIGHT TO NINE INSTITUTIONS SO WE WOULD LOVE TO SEE THE NCA PLAY A I OBJECT INITIAL WITH THIS INITIATIVE SO BEING ABLE TO FUND EIGHT TO 10 OR SIX TO EIGHT INSTITUTIONS AND BY ACTUALLY LOWERING THE INDIVIDUAL GRANTS TO TO BRING MORE PEOPLE TO THIS INITIATIVE WOULD REALLY BE A GREAT IDEA SO WITH A SCRATCH PAD AND PIECE OF PAPER, YOU COULD FUND SIX GRANTS AT THE SAME AMOUNT OF MONEY THAT IS ALREADY BEEN APPROVED FOR THIS INITIATIVE IT WOULD NOT JUST BE $5 MILLION A YEAR OVER THE ENTIRE OR FIVE MILLION DOLLARS FOR THE LIFE OF THE PROJECT SO I WOULD LOVE TO MAKE A REQUEST THE NCI CONSIDER PLAYING WITH THE VERGE GRANT BUDGETS A LITTLE BIT TO BRING MORE INDIVIDUALS AND THE INITIATIVE BECAUSE THIS INITIATIVE IS CRITICALLY IMPORTANT SO THANK YOU VERY MUCH FOR THE OPPORTUNITY TO COMMENT AND THANK YOU. IT'S TERRIFIC. >> OK. WE HAVE A FEW COMMENTS IN THE CHATBOX IF YOU WANT TO ADDRESS IT. >> WE HAVE A CHANCE AND I THINK THE PROPOSAL OF THE GRANTS AT SMALLER SIZE AND IT'S INTERESTING AND WE SHOULD TALK ABOUT THAT AND. >> WE'RE HAVING A HARD TIME HEARING YOU. >> OK. I THINK THERE ARE A COUPLE OF COMMENTS AND WE HAVE A FEW MINUTES KAREN. >> GOOD, I THINK NED WANTED Dr. BAILEY TO COMMENT AND THAT IS WHAT I HEARD HIM SAY. DO YOU WANT TO HAVE THE COMMENTS FIRST? >> YOU NEED TO UNMUTE. >> THANK YOU SO MUCH FOR YOUR KIND WORDS. I DO THINK THAT MANY OF THE MORE ESTABLISHED PROGRAMS DO HAVE THESE RELATIONSHIPS IN PLACE AND WOULD BE WILLING TO QUOTE-UNQUOTE PUT SKIN IN THE GAME BY EITHER MATCHING RESOURCES OR FUNDING AND HOWEVER, WE ALWAYS HAVE THE CONCERN THAT WE WOULD BE UNDER RESOURCING THEM. BECAUSE, AGAIN, IT'S A LEARNING COLLABORATIVE AND WE DON'T WANT TO TRUNCATE THE IMPACT AND EFFORTS BY NOT PROVIDING WHAT IS REQUIRED. SO, WITH THAT BEING SAID, YOU KNOW, WE COULD REVISIT THE SCOPE AND CONSTRUCTING THE R. F.A. WITH THAT PERSPECTIVE IN MIND AND I DO THINK THAT EXPANDING THE NUMBER OF WARDS WOULD BE TREMENDOUS BECAUSE WE WANT TO HAVE SENSITIVITY WITH DIVERSITY WITH RACIAL ETHNIC POPULATIONS AS IT'S BEEN NOTED GEOGRAPHICALLY. THERE ARE FACTORS WE'RE TRYING TO SQUEEZE IN. WE'LL HAVE TO HAVE A CONVERSATION ABOUT THAT. >> THANK YOU, LIANNA. >> I HAVE A QUESTION. >> GO AHEAD MANY OF. >> I HAVE A QUESTION FOR Dr. BAILEY. THIS IS A WONDERFUL PROPOSAL AND IT'S GOING TO HELP A LOT. I HAVE A COUPLE CONCERNS ABOUT, AND IT MAY HAVE BEEN BURIED THERE AND I MISSED IT. PART OF THIS I PRESUME IS GOING TO BE TO DEVELOP NURSE NAVIGATORS THAT CAN HELP REMOVE THE BARRIERS THAT SOME MINORITIES HAVE AND ACCESSING AND UNDERSTANDING CLINICAL TRIALS. THEN I ALSO SAW THAT THEY WOULD BE UTILIZING THEIR CURRENT RESOURCES FOR THIS AND MY CONCERN IS SOME INSTITUTIONS MAY NOT HAVE ENOUGH NURSE NAVIGATORS WHO LOOK LIKE THE PATIENT POPULATION YOU ARE TRYING TO RECRUIT TO CLINICAL TRIALS. I HAVE HAD EXPERIENCE WHERE I HAD A CAUCASIAN COLLEAGUE TRY TO CONSENT AN AFRICAN AMERICAN FOR CLINICAL TRIALS AND THEN GUILE TO DO THE CONSENT AND THEY AGREED WHEN I CONSENT THEM BECAUSE THEY TRUST ME BECAUSE I LOOK LIKE THEM. AND I'VE HAD THAT HAPPEN MANY, MANY, MANY TIMES. SO, I'M CONCERNED THAT IF YOU UTILIZE THE RESOURCES THAT A CENTER ALREADY HAS, THEY MAY NOT HAVE ACCESS TO NURSE NAVIGATORS WHO REFLECT THE MINORITY POPULATION THAT THEY'RE TRYING TO ATTRACT. SO, IS THERE ANY MECHANISM IN PLACE WHERE THEY, IF THEY DON'T HAVE THOSE RESOURCES THAT THEY CAN USE AS MONEY TO GET IT FROM OTHER NOW THAT WE HAVE ALL THESE CONNECTION REQUESTS THE CONNECTIONS WITH THE ELECTRONICS AND THEY CAN CONNECT THEM WITH THE ZOOM CALL YOU HAVE MORE SUCCESS GETTING THEM ENROLLED IN THE CLINICAL TRIALS. >> WE SUPPORT AT THE CENTER THE NATIONAL OUTREACH NETWORK WHICH HAS COMMUNITY HEALTH EDUCATORS THAT LIAISON WITH THE COMMUNITY OUTREACH AND EDUCATION CORE OF CANCER CENTERS AND MANY OF THEM REFLECREFLECT THE POPULATIONS THEY SERVE. SO WE ABSOLUTELY AGREE WITH YOU THAT DIVERSITY IS NEEDED. MANY OF OUR COMMUNITY HEALTH INDICATORS ARE MULTI LINGUAL, RIGHT, AND REALLY HAVE THE CAPABILITY TO TAILOR AND BE CULTURALLY APPROPRIATE. NOT ONLY IN THEIR ENGAGEMENT WITH THE COMMUNITY BUT ALSO WITH PROVIDERS. IT'S NOT NECESSARILY NURSE NAVIGATORS, REGULAR NAVIGATORS, LIAISONS, COMMUNITY HEALTH EDUCATORS, IT'S REALLY INCUMBENT UPON THE APPLICANT TO FIGURE OUT WHAT'S REQUIRED, RIGHT, TO AUGMENT THEIR TEAM AND MAKE THEM MORE EFFECTIVE. EVEN IF THEY HAVE BASELINE MATERIALS AND RELATIONSHIPS, THIS IS IS THE OPPORTUNITY TO INCREASE THE RICHNESS AND RELATE TO YOUR POINT, ENGAGE THESE UNDER REPRESENTED POPULATIONS. >> THAT WILL BE GREAT. THOSE COMMUNITY FOLKS NEED ADVICE HOW TO GET THEM ENROLLED. THAT'S REALLY IMPORTANT. SO THANK YOU. >> SO LOTS OF GREAT SUGGESTIONS IN THE CHAT. LEANNE, I'M SURE YOU WILL BE ABLE TO PERUSE THROUGH THEM. MAYBE WE'LL HAVE ANOTHER COUPLE OF MINUTES, TWO OR THREE MINUTES TO RUN THROUGH SOME OF THEM. HOWARD WAS SUGGESTING TO PROVIDE SOME PERSPECTIVE FROM INDUSTRY EXPERIENCE, HOWARD? >> SURE. I MEAN, I THINK THERE HAVE BEEN MULTIPLE INITIATIVES INDUSTRY TO FOR THE MODERN THERAPIES IN CANCER WHEN THEY'RE DRIVEN BY BIOMARKERS OR DEVICES AND FOR INSTANCE, THERE'S A CANADIAN GROUP THAT IS GONE TO GENERALIZE IT'S CLINICAL TRIAL PROGRAMS AND I THINK IT'S CALLED VENTIS AND THEY'RE SUCCEEDING AND GETTING ENROLLMENT ACROSS MULTIPLE DISTANCE CENTERS AND MINORITY POPULATION THAT'S HAVEN'T BEEN PART OF TRIALS ANYMORE AND YOU SAW MY CHAT, THERE'S EXPERIENCES WERE IN CONTRAST AND THE MYELOMA PROGRAM THAT ENROLLED 20% AFRICAN AMERICANS AND ANOTHER ONE THAT GOT MINORITY AND ELDERLY THROUGH THE V.A. SYSTEM, THROUGH THE V.A. SO ALL I'M SAYING IS THERE ARE INDUSTRY EXPERIENCES THAT HAVE BEEN, I THICTHINK, ON THE POSITIVE SIDE. THESE PEOPLE, THESE ARE TRIALS THAT ARE COMPLETED AND PEOPLE WANT TO SHARE THE GOOD NEWS AND THE GOOD EXPERIENCES AS WELL. >> OK. THANK YOU, COWARD. KAREN, YOU WANTED TO ADD SOMETHING. >> THANK YOU, YOU ARE SAVING ME FROM TYPING INTO THE CHAT. IN THIS CASE, I VERY STRONGLY SUM OR THE CHERYL'S CONTENTION ABOUT EXPANDING TO THE NUMBER OF CENTERS AND IF YOU CAN'T MAKE IT A REQUIREMENT, OR THE NUMBER OF INSTITUTIONS FUNDED, IF YOU CAN'T MAKE IT A REQUIREMENT YOU CAN STRONGLY SUGGEST THERE'S INSTITUTIONAL SUPPORT AND YOU ARE FIND YOU GET IT IN THE SAME WAY AND THAT HAS ALLOWED THERE TO BE FUNDING ACROSS THE WIDE VARIETY OF INSTITUTIONS AND I DON'T THINK IT'S JUST THE WELL RESOURCES ONES THAT WOULD TAKE ADVANTAGE OF THAT AND I WOULD JUST LIKE TO PROPOSE THAT YOU ARE DOING THE CANCER CENTER A PAGE AND THIS IS STRUGGLE AND TO GET RESOURCES SO HAVING THAT EXPECTATIONS AND THERE'S MATCH THAT CAN STILL GET YOU THE SAME LEVEL OF FUNDING AND EXECUTE ON THE PROPOSAL AND IT ALLOWS THIS LEARNING COMMUNITY TO GROW ACROSS THE WIDER AND RURAL VERSUS URBAN IS GOING TO BE DIFFERENT AND COULDN'T AGREE MORE AND SO FOUR, I'M WORRIED IS TOO SMALL OF A SAMPLE SIZE FOR US TO GO WHERE WE WANT TO GO. >> SO, I GUESS THIS IS MY LONG WAY AND TO REQUIRE AN INSTITUTIONAL MATCH OR MAKE THAT STRONGLY ENCOURAGED AND WHATEVER THE SAME LANGUAGE IS IN THIS. >> THANK YOU TO CLOSE AWFUL YOU. IT'S SUCH AN IMPORTANT INITIATIVE AND I CAN'T REMEMBER WHO SAID IT BUT, HAVING NAVIGATORS WHO LOOK LIKE ME AND SPEAK INDIGENOUS OR SPANISH OR OTHER LANGUAGES, WHO CAN SPEAK IN TERMS THAT ARE CULTURALLY ACCEPTABLE AND APPROPRIATE ABOUT RESEARCH AND SOMETIMES INDIGENOUS LANGUAGES IN NEW MEXICO DON'T EVEN HAVE WORDS FOR THE TERMS THAT WE USE AND SO, HAVING THAT PERSON WHO LOOKS LIKE ME IS SO IMPORTANT AND I JUST THINK THE INITIATIVE IS WONDERFUL AND IT WOULD BE GREAT IF WE CAN FIGURE OUT HOW TO GOT MER CENTERS IN THE PROGRAM AND I WANT DER IF THERE'S A WAY TO AUGMENT THE PROGRAM THROUGH SUPPLEMENTS TO CENTERS THAT MIGHT LOOK FOR EVEN A GREATER MATCH FROM THE CENTER SO THEY COULD BE PART OF THE PROGRAM. WITH A SMALL SEED INVESTMENTS FROM NCI SO MANY ARE ENGAGE IN TRYING TO DO THIS WORK ALREADY AND IF WE CAN PART OF THE LARGER COLLABORATIVE THAT Dr. BAILEY PROPOSING THROUGH A LIGHTLY DIFFERENT FUNDING MECHANISM AND TO A CENTER WHO THEN MIGHT PUT UP THE MONEY BECAUSE THEY WANT TO BE PART OF THE LEARNING COLLABORATIVE SO WE REALLY APPRECIATE TO TAKE SOME INNOVATIVE THINKING ABOUT HOW TO EXPAND THE GROUP THAT COULD BE PART OF THIS PRO ANT PROJECT BUT THANK YOU VERY MUCH, AGAIN, EVERYONE FOR YOUR GREAT WORK. >> GREAT, GREAT SUGGESTION AND GREAT DISCUSSION AND FORT A LOTLY WE'RE GOING TO HAVE TO TRY TO FINALIZE IT. I HAVE A QUESTION INFORM PAULETTE. IF WAN WANTS TO CONSIDER SOME OF THE SUGGESTION THAT'S HAVE BEEN MADE NOW, IN TERMS OF INCREASING THE NUMBER OF AWARDS OR ASKING INSTITUTIONAL MATCHING FUNDS, WHAT ARE WE VOTING FOR? BECAUSE IF THERE'S GOING TO BE ANY AMENDMENT, ARE WE VOTING TO APPROVE OR ARE WE VOTING TO DID HE FER UNTIL THESE MODIFICATIONS ARE BEING MADE? >> I DON'T THINK WE WANT TO DEFER BUT I THINK, I DON'T KNOW THAT WE HAVE TO CHANGE THE APPROVAL? WE JUST WOULD LIKE THE -- >> THAT'S WHAT I'M ASKING. >> SO, YOU SIMPLY NEED TO CONCUR WITH THE CONCEPT. WE HEARD COMMENTS AND ET CETERA, AND THEY WILL BE TAKEN NO CONSIDERATION. >> I MOVE TO APPROVE THIS CONCEPT AND ENCOURAGE NCI STAFF TO CONSIDER EXPANDING THE PROGRAM. >> I'LL SECOND THAT. ANY FURTHER DISCUSSION? IF NOT, LET ME ASK HOW MANY OF YOU DISAPPROVE? ANY A ABSTENTIONS. THE MOTION IS CARRIED UNANIMOUSLY. >> THE MOTION CARRIES. >> YEAH. >> THE CAVEAT, AS INDICATED. OK. YOU CAN GO TO THE NEXT ONE. >> OK. >> OK, SO THE NEXT CONCEPT IS A NEW P.A.C. THAT IMPACT CANCER RISK AFTER BAR AT TRICK SURGERY. WE HAVE Dr. SAUTER PRESENTING AND THE SUBCOMMITTEE MEMBERS THAT REVIEWED IT ARE MICHELLE, WHO CHAIRED IT AND DAVID AND GRANT AND I'LL TURN IT OVER TO YOU RIGHT NOW. >> AS STATED, WE'RE GOING TO TALK BRIEFLY ABOUT MECHANISMS THAT IMPACT CANCER RISK AFTER BARIATRIC SURGERY. WHICH IS IMPORTANTLY NEEDED. SO THIS IS A TRANS NCI PARTNERSHIP AND I WON'T GO THROUGH ALL THE LISTS THERE BUT IMPORTANTLY, MY COLLEAGUES ON THIS P.A.R. FROM THE DIVISION OF CANCER BIOLOGY, CHRIS WILLIS AND THE CANCER CELL BIOLOGY BRANCH AND PHIL DASHNER AND THE CANCER IMMUNOLOGY AND SO, I WON'T BELABOR THIS AND 13 CANCERSES ARE INVOLVED AND IT WILL SURPASS TTOBACCO AS THE LEADING CAUSE OF CANCER AND BARIATRIC SURGERY IS THE MOST CONVINCING EVIDENCE THAT WEIGHT LOSS LEADS TO REDUCTIONS IN CANCER RISK AND CANCER MORTALITY. SO, THIS IS AN IMPORTANT PAPER PUBLISHED IN NEW ENGLAND JOURNAL THAT HIGHLIGHTS HOW THE IMPORTANCE OF BARRIE AT TRICK SURGERY AND IMPACTING CANCER RISK. I'D LIKE TO GO OVER -- IT IMPACTS PRE AND POST MENOPAUSAL WOMEN AND IT IMPACTS INDIVIDUALS WITH AND WITHOUT DIABETES. IT IMPACTS PEOPLE WITH THE B.M.I. LESS THAN 40 AND THOSE WITH A B.M.I. GREATER THAN 40. YOUNGER AND OLDER THAN 46 YEARS, SMOKERS AND NON SMOKERS. THIS IS A SWEDISH OBESE SUBJECT STUDY AND THE ONLY LARGE PROSPECULATIVE SURGERY ASSESSING CANCER RISK. IT TOOK 20 PLUS YEARS FOR THIS COHORT TO MATURE SO THEY COULD PUBLISH THIS AND THIS IS IS ONE OF THE BIG ISSUES WITH BARIATRIC SURGERY IN CANCER COMPARED TO BARIATRIC SURGERY AND DIABETES AND CARDIOVASCULAR RISK. SO, ONE OF THE CONFUSIONS IS RELATED TO THE FACT THAT THERE ARE MULTIPLE PROCEDURES THAT HAVE BEEN DEVELOPED OVER THE YEARS IN BARIATRIC SURGERY. TODAY, THE MOST COMMON ARE THE GASTRIC BYPASS, GENERALLY THE ONE ON THE LEFT AND THE VERTICAL SLEEVE GASTRECTOMY AND THAT IS 97% IN THE WESTERN WORLD. THEY'RE DIFFERENT IS INSOFAR AS THE FACT THAT THE GASTRIC BY PASS, WHICH BY PASSES MOST OF THE DOM A STOCK AK AND PART OF THE SMALL INTESTINE IS RESTRICTIVE, THAT IS RESTRICTS THE POUCH AND PART OF THE SMALL INTESTINE IS BYPASSED SO NUTRIENTS NOT ABSORBED TO THE SAME BENEFIT THAT THEY NORMALLY ARE. CONTRAST THAT WITH THE SLEEVE, WHICH IS A RESTRICTIVE PROCEDURE, IT DOES NOT BY PASS THE SMALL INTESTINE. THE QUESTION IS, IS THAT MATTER? IN THE DATA SO FAR SUGGESTS IT MIGHT WELL. FOR EXAMPLE, GASTRIC BY PASS GENERALLY HAS SHOWN A GREATER BENEFIT WITH MORE WEIGHT LOSS AND MORE METABOLIC IMPROVEMENT THAN THE SLEEVE. SO, BARIATRIC SURGERY VERSUS DIET, IN MORBIDLY OBESE SUBJECTS. NOTABLY, THE RATE OF BARIATRIC SURGERY IN THIS COUNTRY AND WORLDWIDE IS INCREASING AND 2019, THE LAST YEAR DATA WAS AVAILABLE IN THE U.S. THERE WERE OVER 250,000 PROCEDURES AND OVER A MILLION WORLDWIDE AND THAT IS A 38% INCREASE IN THE LAST 10 YEARS. BARIATRIC IS INITIAL AND SUSTAINED WEIGHT LOSS, EVEN WITH INTENSIVE LIFESTYLE MODIFICATION AND THERE A IMPROVEMENT OR ELIMINATION WITH TYPE-2 DIABETESES AND NOTABLY, DIABETES IMPROVEMENT OR ELIMINATION OCCURS BEFORE SIGNIFICANT WEIGHT LOSS. THERE'S ALSO REDUCTION IN CARDIOVASCULAR RISK THE PROBLEM IS WE DON'T UNDERSTAND WHY THESE MECHANISMS OCCUR AND NOW THAT WE SEE THAT THERE'S PROBABLY A SIGNIFICANT IMPACT ON CANCER RISK AS WELL, WE DO NOT UNDERSTAND WHAT THE MECHANISMS DRIVING THIS RISK REDUCTION MIGHT BE. SO THE NIH HAS BEEN INVOLVED IN EVALUATION BARIATRIC SURGERY AT LEAST SINCE 1978. THERE'S BEEN THREE NIDDK AND NHLBI CONFERENCES AND THAT IS BECAUSE THE EARLY EFFECTS OF BARIATRIC SURGERY WERE IN DIABETES AND CARDIOVASCULAR RISK. AS I MENTIONED EARLIER. IN 2003, THE NIDDK ESTABLISHED THE LONGITUDAL ASSESSMENT OF BARIATRIC SURGERY AND SINCE THEN THERE'S BEEN LABS TOO AND LABS 3 AND ALSO THERE'S TEEN LABS SO THERE'S LONG STUDENTAL DATA IN THE LABS COHORT AND UNFORTUNATELY THE DATA IS NOT ADJUDICATED REGARDING CANCER AND THAT COHORT AND MORE RECENTLY NOW THAT THERE HAS BEEN INCREASING EVIDENCE OF THE ROLE OF BARIATRIC SURGERY IN CANCER RISK REDUCTION IT'S BEEN A FOCUS OF THE NATIONAL CANCER INSTITUTE, FOR EXAMPLE IN THE 2022NCI ANNUAL PLAN AND BUDGET PROPOSAL IT ADDRESSED THE BOY ALGAE AT THE INTERSECTION OF OBESITY AND CANCER AND IT MENTIONED BARIATRIC SURGERY AS AN APPROACH TO CONTROL OBESITY, LEADING TO THE LOWER RISK OF MULTIPLE CANCERS. SO THERE'S A LOT OF NECK TISMS THAT HAVE BEEN PROPOSED DRIVING OBESITY RELATED CANCER. AND SORRY FAR THESE THE NAME MECHANISMS WHICH BARIATRIC SURGERY WORKS BUT NONE OF THESE HAVE BEEN FORMALLY ADDRESSED AND PROSPECT OF MANNER OR AN ORGANIZED MANNER. LOW-LEVEL INFORMATION, GROWTH FACTOR SIGNALING, INCREASES AND THE USUALLY PLAYERS THAT WE'VE ALL HEARD OF BEFORE, BUT IT'S NOT BEEN FORMALLY STUDIED IN ANY OBJECTIVE MANNER NEXT SLIDE, PLEASE. ZOO SO THERE IS LITTLE PUBLISHED. EITHER IN MODELS OR IN HUMANS. DESPITE THE FACT THERE ARE MANY STUDIED IN ANIMAL MODELS ADDRESSING MECHANISMS BY WHICH IT IMPACTS DIABETES AND CARDIOVASCULAR RISK. AS I MENTIONED THE FOCUS HAS BEEN ON THESE MORE SEEN, EARLIER SEEN BENEFITS AFTER SURGERY LIKE A LOSS OF WEIGHT, REDUCTION IN DIABETES AND REDUCTION IN METABOLIC SYNDROME AS WELL AS CARDIOVASCULAR RISK. SO THE PURPOSE OF THE P.A.R. IS TO PROMOTE STUDIES EXAMINING THE NECKISM WHICH THEY IMPACT CANCER RISK AS WELL AS TO ATTRACT TALENTED SCIENTISTS WHO UNDERSTAND THE DYNAMIC CHANGES CAUSED BY BARIATRIC SURGERY AND THEY'RE ALREADY THERE, THEY JUST ARE NOT EVALUATING THE ROLE OF CANCER AFTER IMPACT AFTER BARIATRIC SURGERY. WE ARE PROPOSING AN R21 TO ALLOW FOR EARLY STAGE OR RESOURCE DEVELOPMENT PROJECTS AND WE DO NOT RECOMMEND A CLIN TAL TRIAL FOR THESE AS WELL AS AN RO1 MECHANISM, WHICH WOULD ACCOMMODATE BROADER SCOPE OR IN-DEPTH MECHANISM STUDIES WHERE A CLINICAL TRIAL WOULD BE OPTIONAL. SO SOME OF THE QUESTIONS AND THIS IS NOT A COMPLETE LIST BUT SOME OF THE IMPORTANT ONES IS DO THE ALTERATIONS AND RISK BIOMARKERS IN CANCER OCCUR BEFORE WEIGHT LOSS AND IF SO IN WHAT ORGANS AND ABOUT WHAT IS IMPORTANT. IS IT THE LONG-TERM WEIGHT LOSS AND REMEMBER WITH BARIATRIC SURGERY, ONE OF THE BENEFITS IS NOT ONLY THAT YOU HAVE A GREATER INITIAL WEIGHT LOSS BUT YOU HAVE A STRONGER, SUSTAINED, LONG-TERM WEIGHT LOSS AND USUALLY ABOUT TWO-THIRDS OF THE WEIGHT KEPT OFF ON AVERAGE. WHAT ARE THE MECHANISMS THAT EXPLAIN THE EVIDENCE THAT BARIATRIC SURGERY IS MORE BENEFICIAL IN WOMEN THAN MEN? DOES BARIATRIC SURGERY INCREASE OR DECREASE COLORECTAL CANCER? THERE ARE SOME PRELIMINARY EVIDENCE IT MITOCHONDRIA INCREASE COLORECTAL CANCER ESPECIALLY AFTER THE GASTRIC BYPASS THAT'S BEEN HYPOTHESIS ABOUT MORE BILE ACIDS IN THE COLIN AND THIS IS NOT BEEN DEMONSTRATE AND RECENT STUDIES SAY THIS IS NOT CORRECT. WHICH CANCERS ARE IMPACTED BY BARIATRIC SURGERY AND WHAT ARE THE MECHANISMS FOR THESE CANCERS BEING IMPACTED? FOR EXAMPLE, IS IT A CASE THAT IS DRIVING THE FEMALE CANCERS THAT WE ARE NOT SEEING IN THE MALE CANCEL SUCH POST MENOPAUSAL BREAST AND UT ERIN. DOES IT INFLUENCE CANCER IMPACT AND IF SO WHAT ARE THOSE MECHANISMS? SO IN THE PORTFOLIO ANALYSIS WE A FEED 28 GRANTS AND ONLY THREE WERE FUNDED AND TWO OF THOSE WERE R21s. CURRENTLY, THERE'S ONLY ONE GRANT THAT'S ACTIVE AND THAT IS PAR AND IT'S NOT REALLY DIRECTLY INVOLVED BECAUSE IT'S FOCUSING ON FESTIVE TEE AND THERE'S ONE APPROVED RFA BUT THAT REQUIRES HUMAN STUDIES. SO, WE THINK THAT OUR P.A.R. IS MORE APPROPRIATE BECAUSE THERE WOULD BE GREATER VISIBILITY AND IT'S ONLY ABOUT 28 GRANTS IN OVER 11 YEARS AND WE REMEMBER A REFERRAL TIE SINGLE CRS STUDY SECTION WITH SPECIAL ADDITIONAL EXPERTISE IN BARIATRIC SURGERY WHICH GENERALLY HAS BEEN MISSING AND SPECIAL REVIEW CRITERIA SHOULD INCLUDE PRIOR EXPERIENCE WITH BARIATRIC SURGERY EXPERIENCE BY ONE OR MORE OF THE INVESTIGATORS AND FOR CLINICAL TRAILS, ONE OR MORE OF THE COLLABORATORS SHOULD BE IN OUR OPINION, A BARIATRIC SURGEON. THANK YOU FOR YOUR TIME. I'M HAPPY TO TAKE QUESTIONS. >> THANK YOU, ED. I'LL TURN IT OVER NOW TO THE SUB MEMBER SUBCOMMITTEE MEMBERS. >> I'LL START. THANK YOU, Dr. SAUTER FOR THIS OUTSTANDING PRESENTATION AND OUR THANKS GO TO YOU AND Dr. WILLIS AND Dr. DASHNER FOR THIS CONCEPT. THE REVIEWERS WERE UNIFORM IN OUR OPINION THIS WAS A TIMELY AND EXTREMELY IMPORTANT CONCEPT. WE FELT THAT IT WAS VERY RESPONSIVE TO THE NEED TO UNDERSTAND THE RELATIONSHIP BETWEEN OBESITY AND CANCER RISK PREVENTION AND OUTCOMES AND TO DEVELOP INTERVENTIONS AND AS YOU HEARD FROM Dr. SAUTER, WE WERE IMPRESSED BY A NUMBER OF THINGS AS WE READ THIS CONCEPT AND ONE OF THEM AS YOU HEARD FROM Dr. SAUTER WAS HOW LITTLE IS KNOWN ABOUT THE NECK MISS TICK LINK BETWEEN OBESITY AND CANCER AND CARRY AT TRICK SURGERY AND THE VERY IMPORTANT QUESTIONS THAT ARE RAISED BY THIS CONCEPT AND WE ALSO FELT THAT THE GOALS OF THE WERE APPROPRIATE THAT PROMOTE STUDIES THROUGH WHICH BARIATRIC SURGERY IMPACTS CANCER RISK AND TO DRAW TALENTED SCIENTISTS WE STUDY BARIATRIC SURGERY AND TO INVESTIGATE IT'S EFFECTS ON CANCER AND AGAIN, WE WERE SURPRISED TO LEARN THAT THERE'S NO OFFER LAP WITH THE CURRENT PORTFOLIO AND THE STUDIES THAT HAVE FOCUSED ON CANCER AS OPPOSED TO THE MAJORITIES THAT FOCUS ON THE EFFECT OF BARIATRIC SURGERY AND DIABETES AND CARDIOVASCULAR. WE WERE SURPRISED THERE WAS NO INFORMATION AVAILABLE FROM OTHER TYPES OF CANCER CONSORTIUM OR GROUPS ON THE GENETIC AND THE CLINICAL FEATURES OF TUMORS THAT ARISE AFTER BARIATRIC SURGERY IS COMPARED TO THOSE ARISE IN PATIENTS WITHOUT BARIATRIC SURGERY AND THERE'S NO DATA THAT'S COME OUT OF EXISTING BIOMARKER CONSORTIUM THAT INFORM THIS QUESTION AND SO IN OUR MINDS THAT EMPHASIZED THE NEED FOR FURTHER STUDIES OF THIS YOU'RE. WE HAVE A ROBUST DISCUSSION AND THE GROUP RAISED CONCERNS ABOUT WESTERN A STUDY SECTION WOULD VALUE THIS TOPIC ENOUGH TO MOVE THIS SCIENCE FORWARD AND Dr. SAUTER EXPLAINED A SPECIAL REVIEW BY THE STUDY SECTION WOULD BE REQUESTED SO THAT ALL OF THE PROPOSALS I REVIEWED AS CONSIDERED AS A GROUP AND WE FELL THAT WAS IMPORTANT AND WE ALSO NOTED THAT THIS CUTS ACROSS MANY AREAS AND MANY NIH INSTITUTES AND WE WONDERED IF THIS SHOULD BE BROADER AND INCLUDE OTHER INSTITUTES BUT RE RECOGNIZED THERE'S A STRONG IMMEDIATE TO KEEP THIS FOCUSED ON CANCER BECAUSE OF THE DIRT OF INFORMATION AVAILABLE AND THAT JUSTIFY REALLY KEEPING IT FOCUSED ON WITHIN NCI AND ONE LAST QUESTION, THERE ARE VERY CRITICAL QUESTIONS AROUND THERE HOW RACIAL AND EFFECT NICK BACKGROUND AND BARIATRIC AND THE MECHANISM INVOLVED AND IT WILL BE HARD TO ADDRESS ALL AND TO HAVE ENOUGH PATIENTS AND ENOUGH STUDIES TO ADDRESS THESE ISSUES AND SOME OF THE OTHER CONCEPTS WE'VE HEARD AND OF ME BEING TOO CONTINUE THESE TYPES OF STUDIES AND REALLY EXPAND THESE ANALYSIS AS WE GO FORWARD SO, I'LL JUST SUMMARIZE BY SAYING WE WERE SUPPORTIVE AND ASKED Dr. SUGANSKI TO COMMENT. >> I THINK MICHELLE REALLY WENT THROUGH ALL OUR QUESTIONS AND ANSWERS AND MY QUESTION IS RELATED TO HOW MUCH IT'S COVERED IN OTHER INSTITUTES AND WHETHER THERE'S ANYWAY OF WORKING TOGETHER AND YOU HEARD THE ANSWER. IT WAS VERY INFORMATIVE FOR ME AND I REMAIN SUPPORTIVE. >> I'M SUNSHINE WILL HE SUPPORTIVE AND I CAN'T ANSWER ALL THESE QUESTIONS WITH ONE AND BRINGING MORE ATTENTION TO THIS WILL BE UNNECESSARY NEXT STEPS SO, FULLY SUPPORTED. ANY ADDITIONAL COMMENTS FROM THE PANEL? JUST CHECKING THE CHATBOX. >> I HAVE A QUICK QUESTION AND THIS MAY REFLECT BY NAIVE TAY. I WAS TRYING THINK ABOUT END POINTS OF A TRIAL LIKE THIS AND IF ONE WERE TO DO A CLINICAL TRIAL, HOW LONG WOULD YOU HAVE TO FOLLOW THESE PATIENTS OUT TO SEE A MEANINGFUL IMPACT ON ANY SORT OF CANCER AND IT WOULD PROBABLY BE SOMETHING LIKE 20 YEARS AND SO, GIVEN AN R015 MECHANISM BY BIAS IS TO THINK ABOUT FRAMING THE RFA IN A WAY THAT YOU WOULD LOOK AT POTENTIAL EARLY BIOMARKERS OR OTHER SORTS OF THINGS THAT MAKING TRACKED AND I WOULD BE INTERESTED IN SOME OF THE EPIDEMIOLOGISTS THINK ABOUT THIS. IT JUST SEEMS A LITTLE UNFEASIBLE THAT YOU WILL LAUNCH A CCSS LIKE COHORT TRIAL AND TO REALLY GET TO THE BOWEL OF WHICH CANCERS ARE EFFECTED AND HOW IS THE INCIDENTS CHANGED AND IT SEEMS LIKE A HARD QUESTION ALTHOUGH I REALLY SUPPORT, YOU KNOW, ANIMAL MODEL STUDY AND BIOMARKER STUFF AND SO I WOULD BE INTERESTED IN I GUESS AS MORE OF A HOW FEASIBLE IS THIS? IT'S THE QUESTION WE ALL ASK IN OUR OWN RESEARCH? HOW DOABLE IS THIS AND HOW LIKELY ARE YOU GOING TO ASK THE IMPORTANT QUESTION HERE. >> HAS ANYBODY EVEN LOOKED AT SAY, CLAIMS DATA OR DATA FROM CRFA IF THEY HAVE ANYTHING MATCHED UP WHERE THEY WERE ABLE TO GO BACK AND LOOK AT PEOPLE THAT HAVE HAD SURGERY AND OUTCOMES LATER BECAUSE AT LEAST THERE'S DATA FROM CLAIMS DATA TO KNOW THAT YOU'VE HAD CANCER AND YOU'VE HAD, I THINK THAT MAYBE I MISSED IT IF IT WAS A PRESENTATION. ED, DID YOU HAVE, HAS ANYBODY DONE THAT TO MOW IF THERE IS THAT ASSOCIATION? >> YES, COULD I BRIEFLY ANSWER THE PRIOR QUESTION. >> SURE, SORRY ABOUT THAT. >> THE FOCUS OF THIS P.A.R. IS NOT ON HUMAN STUDIED. HUMAN STUDIES ARE ALLOWED OR A CLINICAL TRIAL IS ALLOWED IN THE RO1 BUT IT'S A HARD END POINT OF CANCER IN ANIMAL MODELS WITH MECHANISMS. SO YOU KNOW, HAS HAS BEEN BROUGHT UP IT TAKES A LARGE SAMPLE SET, OVER 10 TO 20 YEARS OR MORE TO ACTUALLY ADDRESS THE BARIATRIC SURGERY AND CANCER IMPACT IN HUMANS AND THAT'S BEEN THE THE MAJOR REASON FOR DEET LAY. >> I WANT TODAY JUST MAKE THE POINT THAT YOU ACTUALLY BROUGHT UP VERY WELL THAT RELATES TO THE AN MODEL AND THAT IS NOT WHAT EQUATES WEIGHT LOSS AS AN END POINT WITH THE BARIATRIC SURGERY BECAUSE THE DATA IS ACTUALLY, IF YOU KNOW, VERY COMPELLING AND IN DIABETES AND CARDIO CAS KULAR DISEASE THE TWO ARE NOT LINKED AND THAT ONE HAS BENEFIT BEFORE THE WEIGHT LOSS AND THAT THERE IS EVEN IN THE ABSENCE OF WEIGHT LOSS THERE'S STILL BENEFITS. THE MECHANISM MAY NOT INVOLVE WEIGHT LOSS AS THE PRIMARY POINT AND EMPHASIZING THE BIOLOGY OF THIS IS REALLY A STRONG POINT OF THIS PROPOSAL BECAUSE IT SHOWS WE DON'T REALLY UNDERSTAND HOW BARIATRIC SURGERY IS WORKING. >> I DO WORRY ABOUT THE MIXED MESSAGE IN THE RFA IF IT'S CLINICAL TRIAL ALLOWED BARIATRIC SURGERY HAS TO BE PART OF IT OR IF THERE'S A CLINICAL TRIAL. I TOTALLY AGREE WITH THE LAST INVESTMENT THAT WE WANT TO DO MECHANISTIC STUDIES. >> IT'S I AM PRACTICAL TO DO CLINICAL TRAILS WITHIN A FIVE-YEAR PERIOD WITH THE AMOUNT OF MONEY AVAILABLE IN AN RO1 I THINK. OBVIOUSLY, I DIDN'T HAVE TIME TO ADDRESS ALL OF THIS. FOR HUMAN STUDIES, IT SEEMS TO ME IF THERE'S THE AVAILABILITY, WHICH THERE ARE, OF DATABASEs OR WHETHER YOU LOOK AT CLAIMS DATA, THIS SORT OF THING, THERE'S ALREADY KAISER IS ALREADY PUBLISHED THREE OR FOUR PAPERS ON THIS VERY TOPIC WHERE THEY LOOKED AT THEIR OWN COHORT AND SURGERY IN 2019 AND IT WAS A VERY GOOD PAPER AND ADDRESSING THE ISSUE SO THE ONLY PURPOSE OF A CLINICAL TRIAL TO ME WOULD BE TO VALIDATE YOUR PRE CLINICAL STUDIES OR TO INCLUDE A SMALL PROCESS RESPECTIVE STUDY WITH A RETROSPECTIVE ANALYSIS OF INDIVIDUALS WHO ARE UNDERGOING THE PRESSURE. >> GREAT DISCUSSION. UNFORTUNATELY, I THINK JUST TO KEEP US IN TIME WORE GOING TO HAVE TO PROBABLY MOVE FORWARD BEFORE I ASK FOR A NOTION IS THERE ANYTHING CRITICAL YOU WANT TO ASK TO THE DISCUSS. >> OK. SO, IF NOT CAN I HAVE A MOTION? >> MOVE TO APPROVE SECOND. >> DO I HEAR A SECOND? DAVID? >> I'LL SECOND. >> SECOND, TERRIFIC. ANY FURTHER DISCUSSION DISCUSSION? LOOKING AT THE CAPACITY. HOW MANY ARE DISAPPROVING? ANY AB TENSION? I THINK THE MOTION CARRIES UNANIMOUSLY. IS THE FINAL CONCEPT FOR TODAY'S MEETING IS ALSO CANCER PREVENTION AND CONTROL CLINICAL TRIALS PLANNING GRANTS. Dr. BRANDY HECKMAN-STODDARD WILL BE PRESENTING AND THE SUBCOMMITTEE MEMBERS THAT REVIEWED IT ARE LESS ROBINSON, MELISSA BONDI AND VICKY SEA WALLED AND I'LL TURN IT OVER TO GRANDEY. >> THANK YOU SO MUCH. GOOD AFTERNOON, THANK YOU FOR PRESENTING THIS CONCEPT FOR A NEW TYPE OF FUNDING OPPORTUNITY FOR N. >> Catherine: CANCER PREVENTION AND CONTROL PROGRAM AND RATHER A R34 OR U34 CON BEHALF CANCER PREVENTION AND MY CO-LEAD IN THE DIVISION OF CANCER CONTROL AND POPULATION SCIENCES. AND NCI FUNDS CLINICAL TRIALS THROUGH STANDARD MECHANISMS INCLUDING R21 FOR EXPLORATORY PHASE WHICH ARE THE TRANSLATIONAL R21FOA SHARED BETWEEN CANCER TREATMENT AND DIAGNOSIS AND DCP AS WELL AS CLINICAL TRIALS OPTION AT FOA SUPPORTED BY DCCPS. CLINICAL TRIALS OTHER THAN PHASE 3 TRIALS FOR THE EFFICACY OF CANCER RELATED INTERVENTIONS OR TRIALS OF CANCER IMAGING MOW BALANCE TEASE, CAN BE SUPPORTED THROUGH RO1s AND DCP HAVE SHARED A GENERAL FOAL RELATED TO CANCER PREVENTION AND CONTROL SINCE THE 2019 TRIALS POLICY CHANGES AND FOR INVESTIGATORS, THAT STRUGGLED TO FIND SUCCESS THROUGH THIS MECHANISM, THERE ARE OFTEN QUESTIONS ABOUT THE CHOSEN STUDY DESIGN AND FEASIBILITY OF THE INTERVENTION OR CONCERNS ABOUT THE TRIAL ASSUMPTIONS AND THE SAME IS TRUE FOR CONCEPT THAT'S GET STALLED IN THEIR DEVELOPMENT PROCESS AS PART OF OUR NETWORK INFRASTRUCTURE, INCLUDES PHASE 2 TRIALS AS PART OF THE THE PHASE CLINICAL TRIALS PROGRAMS INCLUDING CANCER CARE DELIVERY STUDIES. THE R34 IS AN NICHE MECHANISM BUILT FOR PLANING AND OVERCOME THESE TYPES OF CHALLENGES THE GOAL IS TO PROVIDE SUPPORT OF A CLINICAL TRIAL OR RESEARCH PROJECTS INCLUDING ESTABLISH RESEARCH TEAMS, DEVELOPMENT OF TOOLS FOR DATA MANAGEMENT AND RESEARCH OVERSIGHTS AND DEVELOPMENT OF A TRIAL DESIGN OR EXPERIMENTAL RESEARCH DESIGN. FINALIZATION OF THE PROTOCOL, PREPARATION OF AN OPERATIONS OR PROCEDURES MAN ALL AND COLLECTION OF FEASIBILITY DATA FOR THE SUBSEQUENT RESEARCH PROJECTS. HERE, IN RELATION TO CLINICAL TRIALS, THE PLANNING GRANT IS DESIGNED TO PERMIT EARLY PEER REVIEW OF THE PASSIONAL AND CONCEPT FOR THE TRIAL AND SUPPORT DEVELOPMENT OF THE ESSENTIAL ELEMENTS AND ALL COST MORTALITY BUT THERE WERE CONCERNS ABOUT THE TOLERABILITY ABOUT THIS INTENSIVE CONTROL ON ONCOLOGY PATIENTS AND CONCERNS ABOUT THE IMPLEMENTATION OF SUCH AN INTENSIVE INTERVENTION IN THE COMMUNITY SETTING. SO IT WAS DESIGN TO DEFINE THE DISTRIBUTION OF BLOOD PRESSURE, CARDIOVASCULAR RISK WARS, INCIDENTS OF CARDIO CAS YOU LAR EVENTS AND AS WELL AS PERFORM A 50 PATIENT PILOT STUDY USING SITE BASED COLOR TER RANDOM SIZED FONG SITES AND COMPARING THE INTENSIVE BLOOD PRESSURE CONTROL TO USUALLY CARE FACILITATED BY A CENTRALIZED BLOOD PRESSURE ADVISORY CORE AND THE GOAL OF INFORMING THE TRAJECTORY OF THE BLOOD PRESSURE CONTROL AS WELL AS THE PARTICIPANTS AND SITE BURDEN. THE SECOND EXAMPLE IS A CANCER PREVENTION INTERVENTION AND ESOPHAGEUS AND THE FOUNDATION OF THIS STUD SEE THATTEN DOUGH SCOPIC AND HIGH GRADE DISPLAY AND THE GOAL OF THIS LAND TRIAL WAS TO CREATE A TRIAL IN LOW GRADE DISPLAYIA BENEFITS AND THEY'RE COMPARING TWO APPROACHES TO THE PRIMARY END POINT COMPARING DEFINED PATIENT REPORTED OUTCOMES BETWEEN THE TWO ARMS AND COMPARING THE PERFORMANCE OF MOLECULAR AND I AM NOT AGO BIOMARKERS FOR RISK STRATIFICATION AND LOW GRADE DISPLAY SHA FOR THE TRIAL. AND OTHER SPECIALISTS. THERE ARE OFTEN CHALLENGING STATISTICAL ISSUES ABOUT THE STUDY DESIGN, CONTROL GROUP, END ENTER AND ALWAYS QUESTIONS ABOUT THE FEASIBILITY OF RECRUITMENT AND THE ACCEPTANCE OF RANDOMIZATION. SO, THE PURPOSE OF THIS CONCEPT IS TO YIELD INFORMATION THAT IS BOTH SCIENTIFICALLY NECESSARY AND ALSO SUFFICIENT TO PERMIT FINAL DECISIONS ABOUT THE DESIGN OR CONDUCT OF THE LARGE PHASE 2 OR BEYOND CLINICAL TRIALS. IT MUST HAVE A SUMMARY OF THE FUTURE PLANNED TRIAL WITH A GOAL OF SAVING TIME AND COST TO ENSURE FUTURE TRIAL SUCCESS. I WANT TO NOTE THAT THIS PLANNING GRANT IS NOT A PREREQUISITE FOR A CLINICAL TRIAL OR LARGE TRIAL THROUGH OUR NETWORK. BUT IT JUST CREATES ONE ADDITIONAL OPPORTUNITY TO GAIN THE INFORMATION NEEDED TO PLAN A ROBUST TRIAL. THEY ARE NOT IDENTIFYING THE APPROPRIATE CONTROL AND COMPARISON GROUP, STANDARDIZEING AND EVALUATING FEASIBILITY OF THE INTERVENTION OR OUTCOME ACROSS MULTIPLE SITES AND PLAN FOG THE BLAH FOR A POPULATION THAT DIFFERS CURL USUALLY FOR WHICH IT WAS DESIGNED AND MODELING DATA TO SUPPORT THE TRIAL ASSUMPTIONS AND STATISTICAL DESIGNING. THERE WILL BE BOTH AN R34 AND A U34 WITH THE R34 BEING INVESTIGATED INITIATIVE AND PREP TRIAL. AND INVESTIGATORS CAN REQUEST ONE TO THREE YEARS OF SUPPORT PREPARTORY WITH A LARGE NETWORK AND THERE ARE ADDITIONAL. HERE, INVESTIGATORS AGAIN CAN REQUEST ONE TO THROW YEARS OF FUNDING WITH THE FOLLOW-UP STUDY POTENTIALLY FUNDED AND CONDUCTED THROUGH THE NETWORK. JUSTIFICATION FOR THE PIR INCLUDES THE NEED FOR AN NCISEP WITH EXPERTISE ON CLINICAL TRIALS, DESIGN, IMPLEMENTATION AND LOGISTICS AND THE INCLUSION OF PATIENT ADVOCATES AND THESE MECHANISMS AND OTHER INSTITUTES ARE ALL MOSTLY REVIEWED BY INSTITUTES SPECIFIC STEPS. SO THEY'LL BE SPECIAL REVIEW CRITERIA AND FOR THE MECHANISM THEY MUST HAVE A LET OF SUPPORT AND ELITE AND WE'LL HAVE TWO RECEIPT DATES PER YEAR AND TO ACCOMMODATE SIX TO 12 APPLICATIONS PER ROUND SO THE APPLICATIONS CAN BE CLUSTERED FOR REVIEW. THIS IS NO SET ASIDE BUDGET FOR P.A.R. BUT THE DIRECTING COST WILL BE LIMIT TODAY $225,000 PER YEAR FOR A TOTAL OF 450 OVER TWO YEARS PROJECTS PERIOD AND IF THERE'S A FEASIBILITY TRIAL AND THE BUDGET CAN BE INCREASED FOR UP TO 600,000 DIRECTING COST OVER A THREE-YEAR PERIOD. WE HOPE TO POTENTIALLY FUND APPLICATIONS PER YEAR ACROSS THE TWO DIVISIONS AND FOR THE MECHANISM THE WORK MUST BE COMPLIMENTARY AND NOT DUPLICATIVE OF THE NETWORK. TO EVALUATE THIS PROGRAM, WE WILL LOOK AT BOTH SHORT TERM AND LONG-TERM METRICS INCLUDING THE NUMBER OF AND MODIFICATIONS AND THE TRIAL THAT RESULTED FROM THE KNOWLEDGE GAINED AND THE NUMBER OF TRIALS THAT THE NUMBER OF PREDDED TO A FULL CLINICAL TRIAL AND MOST IMPORTANTLY, THOSE THAT DEFINITIVELY DID NOT AND IN A REVIEW THAT DID A THIRD WERE NOT TO BE USEFUL AND DID NOT GO ON TO FUTURE CLINICAL TRIALS. AND A NUMBER OF CLINICAL TRIAL APPLICATIONS ARE PROTOCOL AND APPROVED FROM THESE AWARDEES AND THE PUBLICATION OF THE RESULTS, FOR A LONG-TERM METRICS WE'LL COMPARE THE SUCCESS OF TRIAL PLANNED THROUGH THE MECHANISMS VERSUS THOSE PLANNED AND CONDUCTED THROUGH OUR NON R34-U34 AWARDEES. WITH THAT I WANT TO THANK OUR BSA REVIEW AND HE IS I LOOK FORWARERS AND I LOOK FORWARDTO THE DISCUSS ION. >> THANK YOU, VERY MUCH, BRANDY AND I WILL ASK THE CHAIR OF THE COMMITTEE TO START US OFF. I'D LIKE TO THANK YOU FOR A CLEAR AND CONCISE PRESENTATION WHICH NEARED THE CONCISENESS OF THE CONCEPT PROPOSAL THAT WE ALSO RECEIVED AHEAD OF TIME, THAT WHEN MELISSA BONDY AND VICKY AND MYSELF REVIEWED THE CONCEPT, WE WERE IMPRESSED WITH THE PROPOSED MECHANISM, THE NEED AND TO SOME EXTENT SOMEWHAT SURPRISED THIS HADN'T BEEN ADOPTED AT AN EASTERLY YEAR TIME POINT BY THE NCI BECAUSE IT DOES REALLY SERVE A VERY IMPORTANT, WE THINK, IN TERMS OF THE PORTFOLIO DEVELOPMENT FOR CANCER PREVENTION AND CONTROL TRIALS AND WITHIN THE NCI SO TO SORT OF REITERATE JUST A FEW OF THE MAJOR STRENGTHS THAT WE SAW AND THIS IS THAT TYPICALLY FOR TRIALS THAT ARE CARRIED OUT FOR CANCER PREVENTION AND CONTROL, THEY TYPICALLY ARE LARGE AND THEY'RE COMPLEX STUDY AND LARGE IN TERMS OF POPULATIONS AND QUITE OFTEN, VERY COSTLY TO CARRY OUT. FOR THAT REASON, MANY STUDY SECTIONS REALLY SCRUTINIZE THESE TYPES OF PROPOSALS VERY CAREFULLY IN TERMS OF ALL OF THOSE COMPONENTS OF RATIONALE INSTRUMENTS, OUTCOMES, STUDY DESIGN, AND SO FOURTH. FOR THE MOST PART, YOU REALLY SUCCESSFUL APPLICATIONS NEED VERY EXTENSIVE PRELIMINARY DATA AND TYPICALLY, RESEARCHERS CAN USE THE AUDIENCE SOMETIMES THE R21 MECHANISM BUT QUITE OFTEN THEY HAVE TO GO TO INSTITUTIONAL SUPPORT OR FOUNDATION SUPPORT TO GENERATE THIS PRELIMINARY DATA TO ACTUALLY ADDRESS THESE CLINICAL TRIALS MANY OF IT'S A CHALLENGE FOR MANY INVESTIGATORS BECAUSE MUCH OF THE IPSOS-REI SUPPORT IS LIMITED IN SCOPE IN TERMS OF AMOUNT AND DURATION TO REALLY ADEQUATELY ADDRESS THE FEASIBILITY ISSUES TESTIFY THESE TRIALS SO THIS MECHANISM SEEMS LIKE THIS WOULD PROVIDE AN IDEAL WAY TO ALLOW INVESTIGATORS TO GO FORWARD WITH TRIALS. IT WILL HAVE A SUCCESS IN TERMS OF TWO YEARS, ONE WHICH Dr. HECK MANAS TO THARD SAID IT WOULD STOP STUDIES GOING FORWARD FOR R1 SUPPORT THAT MAY BE DETERMINED NOT TO BE TOTALLY FEASIBLE BUT ALSO, I BELIEVE IT WILL FACILITATE SOME VERY IMPORTANT TRIALS THAT SHOULD BE CARRIED OUT AND THEY MAY NOT BE ABLE TO BE SUCCESSFULLY FUNDED THROUGH THE TYPICAL RO1 MECHANISM BECAUSE OF THAT LACK OF VERY EXTENSIVE PRELIMINARY DATA GOING FORWARD. SO, WE THINK THAT THIS IS SOMETHING THAT IS VERY SUPPORTIVE AND THE TRACK RECORD OF THE OTHER INSTITUTES IN USING BOTH THE R34 AND U34 MECHANISMS IS VERY REASSURING IN TERMS OF THE NUMBER OF PROPOSALS AND THE SUCCESS AND THE OUTCOMES SO, IN SUMMARY, I THINK THAT WE ARE AND REALLY THINK THIS MECHANISM WILL FACILITATE NCI'S OVER ALL EXTRAMURAL FUNDING OF CLINICAL AND INTERVENTION-BASED RESEARCH TO PROMOTE CANCER PREVENTION AND CONTROL AND SO, I'LL END THERE AND LET MELISSA AND VICKY ALSO GIVE THEIR COMMENTS. I THINK YOU DID A REALLY GREAT REVIEW OF THE PROPOSAL AND ACTUALLY, WHEN WE RECEIVED THE PROPOSAL TO REVIEW, WE DIDN'T REALLY HAVE ANY COMMENTS AND QUESTIONS FOR BRANDY, BECAUSE IT WAS CLEAR AND WE APPRECIATED THE PACKED THAT THERPACKET AND THERE WAS AN EVALUATION THAT IF IT WAS SUCCESSFUL, THEN IT WOULD PROCEED. IF IT WASN'T SUCCESSFUL, THERE WOULD BE A STOPPING MECHANISM I DON'T HAVE ANY ADDITIONAL COMMENTS. WE WERE IN COMPLETE SUPPORT OF THE PROPOSAL AND MECHANISM AND THE WAY IT WAS PLANNED AND WE APPRECIATED THE FACT THAT THE NHL-BI IS DOING THIS FOR A WHILE AND YOU USE THEIR PROPOSAL AND THEIR MECHANISM FOR ESTABLISHING WHAT YOU WILL BE DOING AT NCI. SO I DON'T HAVE ANY FURTHER COMMENTS. I THINK YOU DID A GREAT JOB OF REPORTING THE SYNOPSIS IN OUR COMMENTS SO THANK YOU. >> I THANK YOU FOR THEIR COMMENTS. I DON'T HAVE ANYTHING TO ADD. I JUST WANT TO THANK BRANDY FOR PUTTING THIS FORWARD. THIS IS A HUGELY-NEEDED MECHANISM AND I THINK IT'S GOING TO BE VERY IMPORTANT GOING FORWARD. >> THANK YOU ALL. IT SEEMS LIKE UNANIMOUS SUPPORT. I WANT TO ASK IF ANYONE HAS ANYTHING TO ADD BEFORE WE MOVE FORWARD WITH VOTING? SO, I WOULD LIKE TO MAKE A MOTION. >> I'D MAKE A MOTION. >> I'LL SECOND IT. >> YOU MADE A MOTION? >> Y. I'LL MAKE TH YES, I'LL MAKE THE MOTI ON FOR APPROVAL. >> AND I'LL SECOND IT. >> OK. >> ANY FURTHER DISCUSSION? I'LL ASK HOW MANY OF YOU DISAPPROVE? ANY ABSTENTIONS? SO, WE HAVE TO CONTRACT ANNUAL PART REISSUANCE AND PAULETTE WILL PRESENT AND WE HAVE TO VOTE TTO CONCUR, NON CON SUR. THE FLOOR IS YOURS. >> SO, I'M NOT USING A POWERPOINT BECAUSE THE LIST OF THE P.A.R. WAS SENT TO BOTH BOARDS PRIOR TO TODAY'S MAKING. I WILL SIMPLY STATE THAT THERE ARE 31 REISSUED P.A.R.s BUT THE BSA'S CONSIDERATION TODAY. THE LIST THAT WAS SENT TO YOU INCLUDED A LINK TO EACH ONE OF THE P.A.R.s AND IF YOU RECALL, NIH PUT IN PLACE A POLICY BACK IN 2019 THAT REQUIRED AN OPEN FORUM DISCUSSION AND ACCEPTANCE AND ADVISORY COUNCIL FOR NEW AND REVIEW R.F.A.s AND P.A.R.s AND IF I RECALL NOTICES AS WELL. BECAUSE OF THE LARGE VOLUME OF P.A.R. REISSUES, THAT THE NCI HAS ANNUALLY, THIS BOARD AGREED TO REVIEW THE REISSUES AS A GROUP NOT INDIVIDUALLY. ADDITIONALLY, YOU REQUESTED METRICS WHILE EVALUATING THE P.A.R.s AND ON THE LIST PROVIDED, PRIOR TO TODAY'S MEETING, THERE WERE METRICS INCLUDED. ALSO, IN 2019, THE B.S.A. APPROVED INDEFINITELY REISSUANCE OF SELECT P.A.R.s AND THOSE P.A.R.s ARE OR WERE THE TRAINING INITIATIVES, REGULAR AND DIVERSITY SPECIFICALLY A CAREER DEVELOPMENT CASE AND RESEARCH EDUCATION R25s AND PRE DOCTORAL AND THE NATIONAL RESEARCH SERVICE AWARDS FOR INDIVIDUALS. FELLOWSHIPS TO PROMOTE DIVERSITY IN HEALTH RELATED RESEARCH. SMALL RESEARCH PROJECT RO3 OMNIBUS AND THE CCSGP30s. AS INDICATED, PREVIOUSLY, THESE PPARs WILL HOWEVER REQUIRE PSA CONCEPT CARE INTO THE PRESENTATION WHEN THERE ARE MAJOR CHANGES IN THE F.O.A. FROM THAT LIST, I JUST WENT OVER THERE ARE FOUR THAT WAS INCLUDED ON THE LIST FOR TODAY'S VOTES SPECIFICALLY THE NCI MENTOR DEVELOPMENT AWARD TO PROMOTE DIVERSITY, THE KO8 AND CLINICAL TRIALS AND THE NCI MEN FORWARD TO RESEARCH SCIENTIST DEVELOPMENT AWARD TO PROMOTE DIVERSITY KO1, AND THE NCI TRANSITION CAREER DEVELOPMENT AWARD K22 CLINICAL TRIALS NOT REQUIRED AS WELL AS THE PAUL CAREER DEVELOPMENT AWARD FOR CLINICAL ONOLOGY K12 AND I AM ADDRESSING THOSE FOUR, BECAUSE ON THE LIST YOU RECEIVED, THERE WERE DATES AND ONE OF THE DATES WENT BACK TO 1984 AND I WANTED TO HELP YOU PUT THIS INTO CON CONTEXT SO BASED ON THAT, YOU WERE ALSO REQUESTED THE B.S.A. TO INDICATE YOUR CONCURRENCE PRIOR TO TODAY'S MEETING. I KNOW WHAT THAT NUMBER IS, BUT I'M GOING TO TURN IT OVER TO CALL FOR THE VOTE BUT FIRST, I WILL ASK ARE THERE QUESTIONS PERTAINING TO THE P.A.R. REISSUESREISSUES? NO QUESTIONS? OK, I'LL TURN IT OVER TO YOU SO YOU CAN CALL FOR THE VOTE. >> I NEED TO CALL FOR A MOTION FIRST? >> YES. >> OK. SO, I NEED A MOTION FOR CONCUR CONCURRING? >> I'LL GIVE YOU THAT. >> OK. >> SECOND. >> SECOND. >> ANY DISCUSSION ITEMS? ALL RIGHT. SO, DOES ANYONE NOT CONCUR? ANY ABSTENTIONS? I THINK WE'RE GOOD, PAULETTE. >> THANK YOU. OK. SCOTT, THE FLOOR IS YOURS. >> THANK YOU. THE BOARDS WILL NOW CONSIDER ON GOING AND NEW BUSINESS. THE NCAB PLANNING AND SUBCOMMITTEE MEETING MET YESTERDAY TO AND THE CHAIR EMBARK AND WILL GIVE A REPORT. >> MY VIDEO IS NOT BEHAVING. THERE WE GO. I THINK THE MEETING HAS BEEN PLAGUED WITH SOME KIND OF SPIRIT ON SOUND. I DON'T KNOW WHAT IS GOING ON. SO I'M JUST GOING TO -- YOU HAVE A LONG REPORT FROM THE BUDGET AND PLANNING COMMITTEE THIS TIME. THERE WAS A LOT TO TALK ABOUT. AND I HOPE THAT THESE ARE THINGS THAT WILL HELP TO YOU THINK ABOUT HOW YOU CAN POTENTIALLY HELP IN AN AREA THAT I THINK WE NEED SUPPORT FOR NCI. I'LL COME TO THAT IN JUST A SECOND. IT'S A REALLY INTEREST YEAR FOR THE NATIONAL CANCER INSTITUTE AND I'VE BEEN INVOLVED WITH THE NCI SINCE THE 1970s SO I'VE SEEN A FEW THINGS COME AND GO, BOTH OUTSIDE AND THE COMMITTEES LIKE THIS AND ALSO FROM INSIDE. TO HAVE A YEAR WHERE WE HAVE A PRESIDENT WHO SAYS THAT HE WOULD LIKE TO DEVOTE 6 AND A HALF MILLION DOLLARS TO ELIMINATING THE SPECTOR OF CANCER IN OUR LIFETIME IS PRETTY SPECTACULAR. SO, YOU KNOW, IT'S KIND OF THE BEST OF TIMES. AS YOU SEE, SOMETIMES THE BEST OF TIMES HAVE UNINTENDED CONSEQUENCE ZOOS WE HAVE TO THINK ABOUT THIS IN TERMS OF OUR FOCUS. AND SO, IF YOU JUST STEP BACK AND THINK SINCE 2016, IN A STUNNING, COMMITTEE YESTERDAY, THAT SINCE 2016, THE NIH HAS RECEIVED $12.85 BILLION IN INCREASES AND THAT 42.7% INCREASE AND THOSE OF US THAT WERE INVOLVED IN DOUBLING OF THE NIH BUDGET, WE THOUGHT THAT WAS A PRETTY BIG DEAL. THAT IS DUE TO A LOT OF SUPPORT FROM OUR FRIENDS IN CONGRESS, ESPECIALLY THE GROUP THAT IS THERE NOW, MANY OF YOU KNOW AND TOM COAL AND PATTY MURRAY AND ROY BLUNT AND THEY'VE ALL BEEN IN TERMS BEING ON TOP OF THIS ISSUE AND WE HAVE CERTAINLY ONE OF THOSE FOLKS AND ACTUALLY TWO OF THEM WHO ARE REALLY, REALLY SUPPORTIVE OF CANCER RESEARCH SO WE'RE SEEING THE BENEFITS OF THAT AND MANY OF YOU IN YOUR VAR YOUR ROLES TESTIFIED FOR APPROPRIATIONS SO YOU KNOW IT REALLY IS AN EXTRAORDINARY TIME FOR CANCER RESEARCH. SO, JUST QUICKLY, A FEW THING I WANT TO POINT OUT. 2021 IS REALLY A SPECTACULAR FOR THE CANCER INSTITUTE. WE RECEIVED A GOOD INCREASE AND WE ALSO GOT OUR NEXT APPROPRIATION OF MOON SHINE MONEY AND ALSO $50 MILLION FROM THE CHILDREN'S CANCER INITIATIVE AND IT ALLOWED US TO ACTUALLY STAY ON POINT FOR FUNDING RO1s AND ALSO FUNDING NEW INVESTIGATORS SO, WE ACHIEVED AN 11% PAY LINE FOR THE RO1s WHICH WAS PART OF THE BY PASS BUDGET AND PART OF Dr. SHARPLESS' GOAL FOR 15% BY 2025. WE'LL KEEP OUR FINGERS CROSSED THERE. 2022, LOOKING AHEAD, LOOKS ON PAPER PRETTY GOOD. WE'RE LOOKING AT $174 MILLION INCREASE FOR THE CANCER INSTITUTE AND SOUNDS GOOD, 2.67% INCREASE, HOWEVER, IF YOU READ THE REPORT THERE ARE A LOT OF SUBSTRACTIONS THAT ARE GOING TO COME FROM THAT BUDGET AND IT CERTAINLY DOES NOT REFLECT NIH'S LEVEL OF APPROPRIATIONS SO, WE'RE CONCERNED ABOUT 2022 BECAUSE IF YOU THINK ABOUT WHAT IS GOING TO HAPPEN, IT IS UNLIKELY THAT WE WILL BE ABLE TO MAINTAIN THE PAY LINES WHERE THEY ARE AND AS WE ALL KNOW, THAT IS A VERY HIGH INTEREST IN THE SCIENTIFIC COMMUNITY AND ALSO TO CONGRESS WHO THIS YEAR ASKED US TO DEVOTE A THIRD OF OUR BUDGET ACTUALLY AT THE NCI TO BEING SEWN THAT WE PAID RO1 GRANTS AT THE HIGHEST PAY LINE WE COULD ACHIEVE WITH THAT KIND OF AN APPROPRIATION. I THINK ALL OF YOU KNOW, WE DEDICATE MUCH MORE OF THAT BUDGET TO FUNDING RO1 GRANTS AND THAN THE THIRD THAT WE WERE ASKED TO DO. IT'S NOT ENOUGH BECAUSE AS THE IT DEMONSTRATE TODAY ALL OF US IF MONEY IS AVAILABLE AND NOT JUST FROM OUR OWN AREA OF CANCER RESEARCH AND THE THINK THE INCREASES ALMOST DAILY TO ENJOYED OTHER AREAS AND WE HAVE A LOT OF PROPOSALS COMING INTO THE CAN NATIONAL CANCER INSTITUTES AND IT EFFECTS THE PAY LINE. THE ESIs, THOSE GO TO YOUNG PEOPLE AND WE'VE BEEN CONTINUING TO DO VERY, VERY WELL TROLL THERE AND I THINK UNDER NED'S LEADERSHIP, WE'VE REALLY DONE WELL AND I THINK ALSO GETTING THE PAY LINEUP AND I COMMEND NED FOR HIS WORK ON THAT. I REALLY THINK THAT IF THIS BUDGET PASSES AND I THINK IT WILL, OBVIOUSLY APPROPRIATIONS ONE THING AND GETTING THE AUTHORITIES IS SOMETHING ELSE SO IT HAS TO GO THROUGH THIS PROCESS THIS YEAR AND I WANT TO SPEND A FEW MINUTES TALKING ABOUT RPAH WHICH ALL OF US HAVE HEARD ABOUT AND A LOT OF PEOPLE KNOW WHAT IS GOING ON AND THERE'S A LOT TO SAY ABOUT IT BUT NOT MUCH TO SAY ABOUT IT YET. IT KIND OF REMAINS A BLANK SLATE IN TERMS OF WHAT'S IT GOING TO BE. AND IT'S MODELED IN THEORY AFTER DARPA AND IF YOU KNOW DARPA, IT IS IN SOME WAYS A LITTLE COUNTER INTUITIVE FOR THE WAY INDIVIDUAL INVESTIGATORS WORK. DARPA IS AN ORGANIZATION THAT WORKS FOR THE DEFENSE DEPARTMENT. IT IS PRETTY OPAQUE IN TERMS OF THE KINDS OF PROJECTS IT UNDERTAKES BECAUSE OF THAT AND IT RUNS ON A SYSTEM OF PROJECT MANAGERS AND THESE PEOPLE ARE REALLY, REALLY GOOD AT WHAT THEY DO. IT TRIES TO BRING THE ACADEMICS TOGETHER TO SOLVE PROBLEMS, THAT'S SORT OF THE BOTTOM LINE AND THEY'RE USUALLY VERY HARD PROBLEMS AND THE PROGRAM MANAGER WITHIN DARPA IS ALL POWERFUL THERE. 100 OF THEM AND YOU SAW ON THE NEWS THAT'S WHAT Dr. COLLINS SUGGESTED THAT THEY MIGHT HIGHER TO STEP UP FOR DARPAH. THERE ARE THINGS DONE AND IN THE WAY WE DO BUSINESS IN RO1s, FOR EXAMPLE, ALTHOUGH THE CANCER INSTITUTE HAS MORE EXPERIENCE THAN ANY OTHER INSTITUTE WITH THE KIND OF SCIENCE THAT WILL BE DONE IN TERMS OF TRANSLATION. WE'RE HOPEFUL THAT THEY'RE GOING TO BE A LOT BETTER AT THIS THAN WE ARE AND TO NED'S COMMENTS ON THIS, IT'S ALWAYS GOOD TO GET MORE MONEY INTO CANCER RESEARCH, PERIOD. WE HAVE PROMISE TO DO THINGS THIS WE CAN'T DO EASILY IN THE CANCER INSTITUTE AND LET ME SAY MORE ABOUT THIS AND WE DON'T HAVE TIME FOR DISCUSSION TODAY BUT I REALLY HOPE YOU GO BACK TO YOUR HOME INNS DISCUSSION AND DISCUSS THIS AND TALK ABOUT IT BECAUSE THERE'S TIME HERE. THERE'S TIME AND TIME IS ON OUR SIDE OF IT. WE HAVE TIME TO SHAPE THIS. Dr. LANDER AND HIS CABINET APPOINTMENT IS GOING TO LEAD THIS AND MOST OF YOU KNOW ERIC. ERIC SERVED ON THE NCAB FOR SEVERAL YEARS AND WORKED WITH US LOWLCLOSELY AND STILL DOES, ON LOTS AND LOTS OF INITIATIVES. THIS, HOWEVER, THIS PARTICULAR IDEA IS THE PRESIDENT'S. IT STARTED WELL BEFORE HE ARRIVED IN THE OVAL OFFICE, SEVERAL YEARS AGO WHEN HE WAS WORKING ON THE MOON SHOT AND HE IS REALLY WANTING TO DO THIS FOR A LONG TIME SO I'M CONVINCED THAT HE IS GOING TO DO IT. EN THE POSITIVE SIDE WE HAVE EVERY OPPORTUNITY TO HELP SHAPE THIS. WE ARE NOT GOOD AT REPRESENTATIVES OURSELVES SO ESPECIALLY SOMETHING AROUND MONEY BECAUSE EVERYBODY SEES US AS SELF-SERVING AND ANYTHING HAVING TO DO WITH ANYTHING IN LEGISLATION IN THE NCI CANNOT SAY ANYTHING ABOUT. THAT'S AGAINST THE WILL YOU. AND WE WANT NED NOT TO END UP, YOU KNOW, IN THE CLINKER, SO, ANYTHING WE DO WILL BE IN OUR COMMUNITIES. AND I THINK THAT THERE IS AN OPPORTUNITY HERE TO HELP SHAPE THIS IN A WAY THAT IT WOULD REALLY BENEFIT US. IF YOU THINK ABOUT IT, THERE ARE SO MANY GREAT THINGS GOING ON RIGHT NOW IN BASIC AND TRANSLATIONAL SCIENCE THAT COULD GAIN FROM THIS. ONE INITIATIVE I'M INVOLVED WITH, THE AACR, AS A VERY LARGE GROUP AND THEIR LEGISLATIVE AFFAIRS PROGRAM THAT PUTS TOGETHER AN APPROACH TO SHAPE THIS AND THEY'RE GETTING SOME ATTENTION FOR WHAT THEY'RE DOING. SO THIS IS A GRAHAM THAT YOU COULD WORK WITH AND I THINK THERE WILL BE OTHER GROUPS THAT ARE GOING TO BE FORMED TO TRY TO HELP SHAPE THIS. NCI HAS A LOT OF EXPERIENCE IN THESE AREAS AND IT SHOULD ACCOUNT FOR A LOT. THE ONE THING WE HAVE MENTIONED IN HERE AND IT SHOULD BE SERIOUS LOW CONSIDERED, BY WHOEVER, ACTUALLY, ENDS UP STRUCTURALLING THIS IS FREDERICK. IT'S THE ONLY FFRDC AT HHS. IT HAS GREAT STRENGTH THIS IS SOME OF THE AREAS THEY'RE LOOKING FOR AND IT HAS AUTHORITIES AND IT NODES SOME MORE AUTHORITY TO DO WHAT NEEDS TO BE DONE IF IT IS DARPA BUT IT SHOULD BE CONSIDERED AND IT IS BEING INTERESTED AND THE LOCATION FOR SOMETHING LIKE THIS SO IT'S A REALLY GOOD IDEA BUT WHEN THERE'S THIS KIND OF MONEY OUT THERE, YOU CAN BET ANY AMOUNT OF MONEY THAT WE'RE GOING TO SEE IS A HUGE INCREASE AND PEOPLE DO NOT NECESSARILY UNDERSTAND UNDERSTAND THIS IS NOT GOING TO MORE MONEY FOR THE KINDS OF THINGS UP THE THE CURRENT BUDGET AND THE NUMBER OF GRANTS AND ONE FEAR WE HAVE DOWNSTREAM IS THIS INLESS THE CANCER RESEARCH COMMUNITY AND AFFAIRLY AGGRESSIVE WAY, AT LEAST FOR CANCER, I DON'T SEE HOW WE GET THE BEST IDEAS AND THESE KINDS OF THINGS ARE SUPPOSED TO IDEAS AND THE OTHER ISSUE IF WE GET THAT GRANTS AND WE DON'T GET AN INCREASE AND IF WE CAN HAVE, ANY ONE OF US OR AWFUL US OR SOME OF US, CAN HAVE MORE INFLUENCE ON SHAPING THE INITIATIVE THEN I THINK WE SHOULD GIVE THIS REALLY SERIOUS EFFORTS BECAUSE I THINK IT'S REALLY IMPORTANT TO CANCER RESEARCH SO THERE'S A LOT OF MORE MATERIAL IN THE REPORT AND PATRICK IS A PERSON THAT SUPPORTS THIS SUBCOMMITTEE AND KEEPS THIS SO THANK YOU, PATRICK. IT'S A WONDER OF WRITE-UP AND THE LAST THING I'LL SAY IS TO ACTUALLY ADVICE HERE AND Dr. COLLINS AND IF ININVITED AND INVITE I WOULD SUGGEST THAT YOU JOIN AT FIT' AND IT'S A AND THE LAST THING I WANT TO SAY, WITH ITS COMMITTEE AND IT'S ABOUT SUGGESTING THAT AT LEAST A PREPORTION OF THIS AND SIX AND A HALF MILLION GO TO CANCER SINCE THAT'S WHERE WE STARTED BUT EVERYONE WHO KNOWS THAT IT'S BEEN EXPANDED TO ALZHEIMER'S AND OTHER DISEASES SO, WE ARE GOING SEE SOME SHIFT TOWARDS AT LEAST PROPOSING TON DEDICATED TO CANCER IF WE WANT TO MAKE A DIFFERENCE SO I'LL STOP THERE. >> NED, DO YOU WANT TO MAKE ANY COMMENTS? ABOUT THE CONCERNS ABOUT PAY LINES? >> YOU KNOW, I THINK WE HAD EXTENSIVE CUSHION AROUND THAT TOPIC YESTERDAY. THE MESSAGE IS THAT LAID OUT THAT THERE'S A REAL OPPORTUNITY TO DO SOME GREAT NEW THINGS AND CANCER RESEARCH BUT WE ARE CONCERNED ABOUT PAY LINES AND I DON'T THINK I NEED TO ELABORATE FURTHER AND I DON'T KNOW IF WE HAVE TIME BUT IF THERE ARE ANY BRIEF COMMENTS I WOULD BE HAPPY TO ENTERTAIN THEM. >> THIS IS JUST A CURIOSITY WHY DO YOU THINK THERE WAS AN ENCHANTMENT WITH A DARPA LIKE MODEL, WHY THERE WAS A CHOICE TO PUT MONEY NO THIS MODEL AND MORE IMPORTANTLY AND THERE LESSONS CONCERNED AND WHAT ARE THE PAINFUL AND ADMINISTRATION AND MAYBE THE CURRENT THE CURRENT FUNDING MECHANISMS. >> I CAN'T REALLY GUESS. I CAN JUST STATE SOME FACTS. MANY OF YOU REMEMBER VICE PRESIDENT BIDEN'S COMMENTS AROUND THE PLANNING PROCESS WERE HE SPOKE WITH GREAT PASSION ABOUT CERTAIN AREAS OF CANCER RESEARCH HE THOUGHT NEEDED TO IMPROVE INCLUDING OTHERS AND THIS THE CONCEPT OF AN ENTER TEE IS SOMETHING THAT THE RESIDENTIAL CANDIDATE JOE BIDEN SPOKE ABOUT PRIOR TO THE ELECTIONS SO THIS IS SOMETHING THAT I THINK IS A HIGH PRIORITY OF HIS AND CERTAINLY NOW WITH HIS ELECTIONS IT'S ONE OF HIS TOP PRIORITIES SO I THINK THAT THOSE OF US IN THE ADMINISTRATION ARE TASKED WITH THE JOB OF ENACTING ON TOP PRIORITIES SO I THINK THE NIH IS A GREAT PLACE TO HOUSE THIS AND CANCER RESEARCH AND AND I DON'T KNOW THE SOURCE OF THE EXACT INTENT OF THIS OR IF THERE'S A SPECIFIC ISSUE OF A AUTHORITIES AND PEOPLE ARE UNHAPPY WITH AND NO ONE SAID SAID THAT TO ME AND I THINK THE FEELING IS THE NIH IS GOOD AT CERTAIN KINDS OF RESEARCH BUT THE IDEAS IS THEY WOULD ADD AND WE DON'T HAVE. >> AND THAT IS HE THOUGHT THAT IDEA THAT SHE MENTIONED ABOUT FREDERICK AND IS THE KIND OF A MODEL AS TO WHAT KINDS OF THINGS THEY MAY BE LOOKING AT AND POTENTIALLY PARTS OF THE INTERMURAL PROGRAM AND IT MADE WE ME WONDER AND SOME OF THE MONEY FROM THIS NEW TISH TIVE TO GO INTO THOSE ACTIVITIES ALLOWING THE NCI TO REPURPOSE SOME OF THE CURRENT BUDGET FOR THE PRIORITIES AND SO TRAINEE AND YOU COULD SEE IF IT'S IN THE CARDS POTENTIALLY. >> I MEAN, IT'S COMPLICATED ACCOUNTING. I THINK THAT THERE ARE LIKELY THINGS THAT THEY WOULD DO NO CANCER RESEARCH THAT THE NCI WOULD WANT DONE AND WITH PROPER COORDINATION, THE NCI WOULDN'T HAVE TO PAY FOR THOSE ACTIVITIES AND IT WOULD FREE UP FRIENDS FOR US IN THAT SENSE, I GUESS. IT'S HARD TO PLAN FOR THAT. >> ONE OF THE EXPERIMENTS THAT ACTUALLY HAPPENED RECENTLY WAS THE FORMATION OF PICORI AS A SEPARATE ENTITY OUTSIDE OF THE NIH AND HAVING SEEN THAT EXPERIMENT GO FORWARD, ALTHOUGH, IT WAS HER OLDED TO DIE AND NOW HAS BEEN REBORN FOR ANOTHER 10 YEARS, YOU KNOW, THERE ARE SOME VERY POSITIVE THINGS THAT CAME OUT OF THAT PECORI SUPERVISOR THAT HAVE INFLUENCED THE NIH DRAMATICALLY. ONE WONDERS IF THEY WILL SET UP ANOTHER OUTSIDE THE NIH INSTITUTES BASED ON WHAT HAPPENED WITH PECORI. THE POLITICS OF OUR PAGE ARE EARLY BECAUSE WE HAVE A PARAGRAPH OR MORE ON A LOT OF WELL INTENTIONED PEOPLE TRYING TO FIGURE IT OUT. IT'S GOING TO BE INTERESTING TO SEE HOW THIS EVOLVES. MY INITIAL GUT REACTION WAS NEGATIVE BECAUSE IT WOULD BE BETTER IF WE CAN GET ALL THE COMPONENTS WORKING BETTER TOGETHER OF HHS ON THE OTHER HAND, SOMETIMES STARTING FRESH IS A WAY TO CATALYZE CHANGE AND CANCER IS ONE OF THREE PROMINENTLY FEATURED DISEASES BUT YOU WONDER, HOW WILL THE BALANCE, PARTICULARLY FOR DIABETES AND ALZHEIMER'S HOME, HOW IT'S GOING TO ACTUALLY BE IN BALANCE OF ALL. SO, THIS IS A MAJOR EXPERIMENT THAT IS HAPPENING. >> WE'RE OUT OF TIME. DO YOU HAVE A QUICK COMMENT. >> JUST A QUICK COMMENT. I THINK BUILDING ON KEVIN'S COMMENT AND I AM SITTING ON THE AACR WORKING GROUP WITH ANNA AND OTHERS TO HELP WRITE THIS REPORT, WHICH I KNOW WILL WANT TO INTERACT WITH YOU ABOUT. MANY OF US WONDERED AND REALLY COMMENTED ON HOW THOSE RRRPA FUNDS COULD BE USED IN A LDRD LIKE MANNER LIKE THE FREDERICK PROJECT BUT WITH THE NCI COORDINATING AREAS OF FOCUS AND SYNERGY AND IN A WAY THAT WOULD BE A PARALLEL ONE, A PARALLEL WAY TO FUND MORE FUNDS FOR OUR CANCER PROGRAMS. I THINK THAT'S A DIRECTION WE VERY MUCH WOULD LIKE TO TRY TO GO INTO WITH OUR RECOMMENDATIONS BUT I'M ONE PERSON AND WE'LL SEE HOW IT PLAYS OUT OVER TIME. IS THAT SOMETHING, I'D JUST LIKE YOU TO SAY MORE ABOUT THAT? THAT YOU ENVISION THAT COULD BE A WORK OF A MODEL? DO YOU SEE IT AS A FREDERICK-TYPE MODEL? >> I DON'T THINK IT'S A FREDERICK-TYPE MAUD NOT MODEL AND THE POINT I WAS TRYING TO MAKE IS THAT IT COULD USE ANY AVAILABLE VEHICLE TO GET ITS SCIENCE DOES AND THE FFRCs MIGHT HAVE ADVANTAGES FOR THAT AS FOR NOVEL CONTRACT MECHANISMS OR HIRING AN INDUSTRY PARTNER. SO, I THINK THE NIMBLENESS AROUND THE RPH IS SORT OF VEHICLE AND MECHANISM AGNOSTIC AND THAT IS CERTAINLY THE WAY DARPA DOES THING AND YOU ARE NOT MARRIED TO ONE STRUCTURE OF GRANTS OR CARTS AND I THINK THE A LOT OF QUESTIONS WE REALLY CAN'T ANSWER ABOUT AND IN A WAY IT EXISTS. HOW IT WILL EXACTLY WORK WITH THE EXISTING NIH'S FRANCIS COLLINS WAS ASKED ABOUT THIS AT THE HEARING AND YOU KNOW, I ROW REFER YOU TO HIS REMARKS. HE SAID HE ENVISIONED THIS ENTITY WOULD WORK CLOSELY WITH THE OTHER 27ICs AND STUDENT CENTERS IN THE NIH. PRESUMABLY TO HELP PLAN INITIATIVES, BENEFIT FROM EXISTING INFRASTRUCTURE OF THOSE INITIATIVES AND BENEFIT FROM EXPERTISE IF YOU JUST KNOW ABOUT WHAT IT WOULD TAKE TO STAFF UP 100FDEs YOU REALIZE A LOT OF MONEY AT THIS FISCAL YEAR WOULD REQUIRE SUPPORT FROM EXISTING INSTITUTES AND CENTERS. I THINK THERE ARE TWO KIND OF EXISTING MODELS AT THE NIH. THERE'S THE COMMON FUND INITIATIVE, WHICH IS SOMETHING THAT IS SUCCESSFUL IN THE NCI HAS A GREAT RELATIONSHIP WITH MANY OF THE PROGRAMS AND THE FIRST INITIATIVE I HEARD ABOUT YESTERDAY WHICH I'M WILDLY ENTHUSIASTIC ABOUT AND WE'LL TALK ABOUT IT AT A FUTURE DATE. THAT'S COMMENT ON FUND INITIATIVE THAT WE HELPED PLAN AND IT'SE IT'S TERRIFIC. IT'S MORE TOWARDS THE OTHER MODEL WHICH IS THE NCAT MODEL WHICH IS A SPECIFIC ENTITY THAT WORKS. THAT MODEL CAN WORK FOR THE NCI TOO AND WE WORK CLOSELY AND WE HAVE IMPORTANT JOINT PROJECTS. WHEN THE STRUCTURE SET, I THINK THE ICs WILL FIND A WAY TO BENEFIT FROM THE STRUCTURE AND WORK FROM IT. >> THAT WAS A FANTASTIC DISCUSSION. I WOULD ENCOURAGE EVERYONE TO GO AND READ THE REPORT AND IF YOU HAVE THAT AND JUST CAME OUT THIS MORNING. DO WE HAVE A MOTION TO ACCEPT? >> SO MOVED. >> SECOND. >> SECOND. >> ANY ABSTENTIONS AND THIS IS NCAB MEMBERS ONLY? SEEING NONE. THE REPORT IS ACCEPTED AND THERE'S ONE ADDITIONAL BSA ITEM FOR ONLY THE BSA'S CONSIDERATION AND NED WILL PRESENT. >> WE MUTED HER. >> ALL OF YOU RECEIVED THE FUNCTIONAL STATEMENT LATE FRIDAY TO ESTABLISH AN AD HOC CHILDHOOD CANCER CENTER AND DATA INITIATIVE DURING COMMITTEE AND NED IS GOING TO SHARE HIS THOUGHTS FOR THAT. THANK YOU FOR HELP WITH AN IMPORTANT ISSUE. I THINK MANY OF YOU REMEMBER THE DECEMBER JOINT BOARD MEETING WE HAD A PRESENTATION FROM JIM AND WARREN ABOUT PROVIDING AN UPDATE ON THE CHILDHOOD CANCER INITIATIVE OF THE CCDI AND YOU REMEMBER A LOT OF THE CONCEPT AND THE DRIVE HYPED THE CCDI CAME FROM A WORKING GROUP THAT OTIS AND KEVIN SHARED THAT SORT OF HELPED US THROUGH THE ISSUES OF WHERE WE WANT THIS INITIATIVE TO GO. SINCE THAT MEETING, IN DECEMBER, WE'VE BEEN THINKING A LOT ABOUT ISSUES OF GOVERNANCE AND HOW WE'RE GOING TO GET ADVICE FROM THE EXTERNAL COMMUNITY AND WE'LL GET INPUT FROM THE EXTERNAL COMMUNITY AND I THINK IT'S BECOME IMPORTANT TO US THAT WE HAVE THE ABILITY TO FULLY ENGAGE WITH EACH OTHER AND IN A SOMEWHAT AND THAT IS WHAT WOULD BE HELPFUL TO THE NCI TO ESTABLISH A TEARING COMMITTEE THAT REPORTED TO THE BSA FOR THE CCDI SO THAT WE MAY FORMALLY ENGAGE OTHERS IN THE EFFORT AND THE FUNCTIONAL STATEMENT THAT PAULETTE SENT TO THE BSA I THINK OUTLINES WHAT WE HAD IN MIND HERE AND THIS IS A GROUP THAT WOULD REPORT AS APPROPRIATE TO THE BSA AND THIS IS A CRITICAL ENDEAVOR FOR THE NCI AND SOMETIMES THAT'S HIGHLY WATCHED AND I BELIEVE IT'S ALSO A REALLY IMPORTANT SORT OF EXPERIMENT IF YOU WILL FOR HOW WE CAN DO DATA AGGREGATION AND DATA SHARING FOR ALL OF CANCER, NOT JUST CHILDHOOD CANCER SO WE WANT THIS EFFORT TO BE SUCCESSFUL AND THE ABILITY TO INTERACT OR FORMALLY WITH THE EXTERNAL COMMUNITY WITH THIS SUPPORT OF A STEERING COMMITTEE WOULD BE EXTREMELY HELPFUL. SO THAT IS THE PROPOSAL. I'M HAPPY TO ANSWER QUESTIONS ABOUT THE NEED IF THERE ARE ANY. >> THIS IS LES. I FULLY SUPPORT IT COMPLETELY. CAN YOU JUST CLARIFY FOR ME THE AD HOC OF THE STEERING COMMITTEE? IS THIS -- WHERE DOES IT FIT WITHIN THE CCDI STRUCTURE? JUST AN ADVISORY? >> WELL, YOU KNOW, AS YOU KNOW, THE AD HOC, IT WOULD EXIST FOR A WHILE. WE NEED THIS STEERING COMMITTEE FOR YEARS, AS YOU KNOW THE PLANNED DURATION OF THE CCDIs. THIS WOK A SORT OF A TRANSMISSION IF YOU WILL, THAT WOULD TAKE THE WORKING GROUP, THE INPUT THAT WE'RE GETTING FROM VARIOUS ACTIVITIES LIKE THE REGISTRY INITIATIVE OR THE SEQUENCING INITIATIVE WHERE WE ARE ENGAGING WITH LOTS OF PEOPLE AND HEARING THOUGHTS AND THAT WOULD THEN BE THE KIND OF INNOVATION THAT WOULD BE REPORTED AT SOME FREQUENCY BY THIS WILL STEERING COMMITTEE TO BE THE BSA SO THE BSA CAN SEE WHAT WE'RE DOING AND PROVIDE ADVICE AND MAKE SURE IT'S HEADED IN THE DIRECTION TO THE COUNCILS TO THE NCI AGREE WITH. >> GREAT. THANK YOU. >> I STRONGLY SUPPORT THIS IDEA HAVING BEEN THROUGH THE VOTE AND THE PROCESS IN REALLY REALIZING WHAT A COMPLICATED TASK THIS IS FOR THE NCI. MY ADD VOICE IN CONSTITUTING THE STEERING COMMITTEE AND I THINK REALLY NEEDS VERY BROAD REPRESENTATION FROM OUTSIDE OF THE PEDIATRIC ONCOLOGY AND PARTICULARLY ADULT ONCOLOGY AND PEOPLE WITH INDUSTRY. I THINK WE REALLY NEED TO GET AWAY FROM WHAT SOMETIMES IS HAPPENING TO PEDIATRIC ONCOLOGY AND THE TASK WHICH IS A FAIR AMOUNT OF WE REALLY NODE TO BRING NEW IDEAS AND NEW PEOPLE IN FROM OTHER DOMAINS AND AREAS TO ADVISE OUR SPECIALTY. >> LET ME -- I THINK WE HAVE A FAIRLY HUGE NUMBER OF PEOPLE THAT WANT TO TALK TO THE NCI ABOUT CHILDHOOD CANCER INCLUDING THOSE YOU JUST MENTIONED AND ONCOLOGISTS AND ADVOCACY AND PROFESSIONAL DATA WRANGLERS AND I THINK THAT WE HAVE BUILT A STRUCTURE AND IF YOU COULD AND BEYOND FUNCTION OF THIS GROUP WOULD BE TO INTEGRATE THAT AND REPORT IT TO THE BSA IN A TIMELY WAY SO YOU CAN HAVE A DIGESTIBLE AMOUNT OF DATA. I SUPPOSE IF THE BSA WANTED TO HEAR ABOUT COMPONENTS OF THOSE PROPOSALS, WE CAN ARRANGE FOR MORE DISTINCT PRESENTATIONS. THERE ARE A LOT OF DIFFERENT PARTS THAT THE BSA MAY BE INTERESTED IN. THIS STEERING COMMITTEE ITSELF WOULD LIKELY BE ON THE SMALLER SIDE BECAUSE LARGE STEERING COMMITTEES ARE HARDER TO MANAGE BUT WOULD HEAR INPUT FROM A HUGE NUMBER OF DIVERSE E. TERNAL PEOPLE WITH THE EXPERTISE YOU MENTIONED. >> I WOULD SAY THE SMALL COMMITTEE AS WELL BUT IT SHOULD BE REPRESENTED WITH NON PEDIATRIC REPRESENTATIVES ON IT. >> I'M TOTALLY SUPPORTIVE OF CONCEPT, NED, OF THE SUM AND COMMITTEE BECAUSE IT'S A TREMENDOUS AMOUNT OF WORK. SOME PEOPLE NEED TO FOCUS ON COMMUNICATING THE SALELY ANT POINTS TO THE BSA. >> I HAVE A QUESTION. WAS IT RE STRICTED TO THE UNITED STATES OR WILL THAT ALSO INCLUDE PEOPLE OUTSIDE OF THE U.S. BECAUSE THIS IS A COMMUNITY THAT WORKS ACROSS THE GLOBE? BECAUSE OF THE TUMORS. >> RIGHT. THANK YOU FOR THE QUESTION. YOU KNOW, KEVIN AND OTIS CAN TALK ABOUT THEIR RECOMMENDATIONS BUT OUR VISION HAS ALWAYS BEEN THAT WE WOULD TRY AND LEARN FROM AS MANY CHILDREN WITH CANCER AS POSSIBLE. THERE ARE BARRIERS TO DATA TRANSFER BETWEEN COUNTRY. WE HAVE A NUMBER OF ACTIVITIES WITH INTERNATIONAL PARTNERS WHERE WE ARE TRYING TO SEE IF WE CAN LINK DATASETS, LINKING GENOMIC DATASETS. USAGE FUNDS INTERNATIONALLY IS AN ISSUE YOU ARE ALREADY FAMILIAR WITH. WE HAVE SOME ABILITY TO DO THAT BURR IT'S NOT UNLIMITED. THE GOOD NEWS HERE IS THAT THIS IS A REAL COALITION OF THE WILLING, AS I TALKED TO OTHER NCI COUNTERPARTS OVER THE COUNTRIES AND THEY'RE OFTEN INTERESTED TO TALK TO PEDIATRIC CANCER AND BE THAT BOTH IN AFFLUENT COUNTRIES, I SUSPECT THIS MIGHT BE THE KIND OF THING WE TALKED TO THE U.K. ABOUT. I MENTIONED THE U.K. YESTERDAY AND LOW AND MIDDLE COUNTRIES THERE'S AN INTEREST IN SOME BETTER SORT OF DATA HARMONIZATION TO THE EXTENT POSSIBLE AND THERE ARE SPECIFIC COUNTRY WITH A REAL EXPERTISE IN A SPECIFIC DISEASE AND WE WANT TO INCLUDE THAT AND SOME DIAGNOSIS THAT ARE SO RARE YOU HAVE TO HAVE LARGE COUNTRIES TO MAKE PROGRESS. FOR THOSE REASONS, WE VERY MUCH ENVISIONED INTERNATIONAL PARTNERSHIPS AS MUCH AS POSSIBLE. >> TRYING NOT READ HER MIND TOO MUCH BUT SOMEONE MIGHT (INAUDIBLE) FROM GERMANY WHO HAS DONE A PHENOMENAL JOB OF ORGANIZING THIS KIND OF EFFORT. IT WOULD BE PHENOMENAL FOR OUR STEERING COMMITTEE TO BRING SOMEONE IN WHO THOUGHT ABOUT THIS DEEPLY AND IMPLEMENTED SOMETHING THAT MIGHT WORK FOR US AND IT MIGHT NOT WORK BUT IT'S A MODEL TO CONSIDER. SORRY IF I WAS THINKING ALONG DIFFERENT LINE THAN YOU. >> THAT'S A EXACTLY WHO I WAS THINKING OF. ALSO, THERE ARE SOME EFFORTS IN THE U.K. AS WELL. WITHIN EUROPE ITSELF. >> PETER ADAM SOSON ISN'T HERE. >> DID WE LOSE SCOTT? >> HELLO. >> I THINK YOU NEED TO CLOSE THIS AND CALL FOR IN AUD. > -->> WE NEED A MOTION TO ACCEPT THE RECOMMENDATION I THINK. >> OK. YEAH. THAT'S RIGHT. I RETIRED PREMATURELY. OK. SO, I NEED A MOTION. >> I MAKE A MOTION TO APPROVE THE STEERING COMMITTEE. >> I SECOND IT. >> SECOND. >> WOW. WOW. SEW MANY SECONDS. >> I WANT TO CLARIFY THE LABEL TO ESTABLISH THIS COMMITTEE AND PROVE ESTABLISH RENT OF THE CCDI STEERING COMMITTEE, OK. >> THANK YOU, PAULETTE. >> OK. THE MOTION IS STILL THERE. I HAVE A YES. >> SO, ANY DISCUSSION? ALL RIGHT. SO WE NEED NAYs. ABSTENTION? I THINK THE MOTION CARRIES. >> THE MOTION CARRIES. >> ALL RIGHT. >> ALL RIGHT. >> ARE THERE ANY OTHER ISSUES FOR THE BOARD'S CONSIDERATION? THE ONE I WOULD LIKE TO BRING UP IS JUST TO THANK DAFNA FOR HER RELATIONSHIP. IT'S FANTASTIC SO, ALL THE OTHER BSA MEMBERS WHO WERE RECOGNIZED YESTERDAY. THANK YOU FOR YOUR SERVICE. FANTASTIC. IF THERE'S NO OTHER BUSINESS, THE MEETING IS ADJOURNED. WE'LL SEE THE NCAP VIRTUALLY IN SEPTEMBER. AND HOPE EVERYBODY HAS A GREAT SUMMER. STAY HEALTHY. >> THANK YOU.