I WANT TO WELCOME EVERYONE AGAIN. THIS IS DAY 2 OF OUR JOINT BOARD MEETING. I'D LIKE TO WELCOME THE BOARD OF SCIENTIFIC ADVISERS AND THE NATIONAL CANCER ADVISORY BOARD, THE EX-OFFICIO MEMO BETTERS, LIAISON REPRESENTATIVES, STAFF AND GUESTS. WE HAVE SIX NEW CANCER MOONSHOT CONCEPTS FOR THE BOARD TO CONSIDER. THE BSA MEMBERS WILL VOTE TO APPROVE, DISAPPROVE OR DEFER A CONCEPT. BOTH NCAB AND BSA MEMBERS WILL PARTICIPATE IN THE DISCUSSION BUT ONLY THE BSA MEMBERS CAN VOTE. >> GOOD MORNING, EVERYBODY. SO WE'RE GOING TO GET RIGHT INTO IT. OUR FIRST CONCEPT TODAY IS IMMUNOONCOLOGY TRANSLATION NETWORK OR THE IOTN. THIS IS AN RNA COOPERATIVE AGREEMENT. WE'LL HAND IT OVER TO NANCY. THANKS FOR JOINING US THIS MORNING. >> OKAY. SO GOOD MORNING. I'M GOING TO THIS NETWORK WAS FORMED IN RESPONSE TO RECOMMENDATIONS FROM THE BLUE RIBBON PANEL FOR IMMUNOONCOLOGY, AND ESSENTIALLY THE OVERALL GOAL IS TO ACCELERATE THE TRANSLATION OF BASIC DISCOVERIES INTO TRANSLATIONAL AND CLINICAL APPLICATION, AND SPECIFIC RECOMMENDATION WAS TO CREATE A NETWORK FOR TRANSLATIONAL SCIENCE. AND SO THE TEAM -- THE IMPLEMENTATION TEAM, WHICH I'M A PART OF, WAS WORKING TO SORT OF OUTLINE HOW WE COULD SUPPORT THE DISCOULD COVER REAND EVALUATION OF NOVEL IMMUNOTHERAPY BASED APPROACHES AS WELL AS TO IDENTIFY BARRIERS THAT PREVENT SORT OF MORE WIDESPREAD APPLICATION OF EXISTING THERAPIES, AND SECOND TO THIS, WE ALSO WANTED TO SUPPORT DEVELOPING VAC SEEPS FOR EARLY PREVENTION FOR HIGH RISK GROUPS. SO WHAT I WANT TO DO IS JUST SORT OF GIVE YOU AN OUTLINE OF WHAT OF EXISTING NETWORK IS SO YOU HAVE SOME CONTEXT AS TO HOW THE NEW INITIATIVES WE'RE PROPOSING WILL FIT IN. SO WHAT WE DID IN THE LAST YEAR WAS WE ISSUED FOUR RFAs. SO THE ONE AT THE TOP, THE CANCER IMMUNOTHERAPY RFA WAS DESIGNED TO SOLICIT PRE-CLINICAL BASIC DISCOVERY RESEARCH FOR IMMUNOTHERAPY AND THESE ORGAN SITES THAT YOU CAN SEE AROUND THE CIRCLE WERE PRIORITIZED IN THIS RFA BECAUSE THOSE WERE ALSO PART OF THE RECOMMENDATION OF THE BLUE RIBBON PANEL AND THEY ALSO ALIGNED WITH SOME OF THE EFFORTS IN THE HUMAN TUMOR ATLAS NETWORK. THEN WE ALSO PARTNERED WITH OTHER INSTITUTES SO WE'VE EXPANDED THIS TO ALSO INCLUDE GLIOBLASTOMA, HEAD AND NECK, AS WELL AS LIVER CANCER, SO THIS WAS VERY WELL RECEIVED. WE GOT 72 APPLICATIONS IN RESPONSE TO THIS, SO WE'VE COVERED MOST OF THESE ORGAN SITES AS WELL. THE SECOND MAJOR RFA THAT WE PUT OUT WAS FOR CANCER IMMUNOPREVENTION, AND I'LL DEFER TALKING ABOUT THAT NOW BECAUSE I'M GOING TO COME BACK TO THAT IN A COUPLE OF SLIDES. THE OTHER THING WE WANTED TO HAVE WAS TO ESTABLISH A DATA MANAGEMENT RESOURCE CENTER. SO THIS CENTER WOULD BE CHARGED WITH FACILITATING THE TRANSFER OF DATA BETWEEN THE DIFFERENT P.I.s FUNDED THROUGH THE DIFFERENT UL1 MECHANISMS AND ALSO IT WOULD HELP ORGANIZE AND DIRECT THE STEERING COMMITTEE THAT WAS GOING TO BE COMPOSED OF P.I.s FROM EACH OF THE UL1 GRANTS, ADVOCATES AND MEMBERS OF THE NIH STAFF. THE LAST PIECE IS THE CELLULAR IMMUNOTHERAPY DATA SOURCE. THIS IS BEING ESTABLISHED SO THAT DATA COMING FROM ONGOING CLINICAL TRIALS CAN BE MADE AVAILABLE TO THE RESEARCHERS IN THE NETWORK AND HELP SORT OF GUIDE SOME OF THEIR CHOICES GOING FORWARD. SO THIS IS THE BASIC FRAMEWORK THAT WE PUT INTO PLACE AND THEN THE OTHER PIECE OF THIS IS JUST SHOWING HOW IT ALSO INTERFACES WITH A NUMBER OF EXISTING NCI PROGRAMS AND THEY'RE ALL LISTED DOWN THE SIDE. BUT I WON'T GO THROUGH ALL OF THESE BUT I JUST WANT TO DRAW YOUR ATTENTION TO THE PDAC, PANCREATIC CANCER CONSORTIUM, BECAUSE THAT WAS FORMED THE YEAR EARLIER AND THAT'S FOCUSING ON SETTING THE IMMUNE MICROENVIRONMENT AND N. PANCREATIC TUMORS, SO THAT'S ALSO PART OF THIS LARGER CONSORTIUM. SO GOING FORWARD, THERE ARE TWO NEW INITIATIVES THAT WE THINK WILL NICELY COMPLEMENT WHAT WE HAVE GOING ON ALREADY. AND I'LL TALK ABOUT THOSE TODAY AND NAMELY, THERE'S A NEW CANCER IMMUNOPREVENTION INITIATIVE THAT WE'D LIKE TO ADD AS WELL AS THESE IMMUNOENGINEERING OR I3 CENTERS. SO I'LL START WITH THE IMMUNOPREVENTION RESEARCH PROJECTS. AS I MENTIONED, WE HAD AN EXISTING RFA FOR UL1 GRANTS AND THE GOALS FOR THE NEW INITIATIVE THAT I'LL GIVE YOU SOME DETAILS ABOUT WILL BE THE SAME, AND SO THE IDEA WITH THE IMMUNOPREVENTION IS TO TRY TO IDENTIFY NEOEPITOPES OR NEOANTIGENS OR OTHER ACTIONABLE TARGETS THAT YOU CAN USE TO THEN DEVELOP VACCINES FOR CANCER PREVENTION, AND THE STRATEGY IS TO FOCUS ON THESE HIGH RISK POPULATIONS, THESE ARE INDIVIDUALS THAT ARE GENETICALLY PREDISPOSED TO DEVELOPING CANCERS, AND THERE'S A NUMBER OF THEM LISTED HERE. SO THIS WOULD BE THE OVERALL APPROACH AND STRATEGY, AND I HAVE JUST ONE SORT OF SCHEMATIC EXAMPLE OF HOW THIS COULD WORK, AND SO THIS IS USEING LINT SYNDROME, SO THESE INDIVIDUALS HEUL TEULLY HAVE -- THEY'RE SUBJECT TO DEVELOPING THESE RECURRENT FRAME SHIFT MUTATIONS, SO THIS GIVES RISE TO THESE UNIQUE PEPTIDE NEOANTIGENS AND THOSE CAN BE USED TO DEVELOP VACCINES, AND THIS IS AN EXAMPLE FROM A PHASE 1 CLINICAL TRIAL AND IN THIS CASE, A MULTIVALENT PEPTIDE VACCINE WAS DEVELOPED AND COULD THEORETICALLY COVER UP TO 98% OF PATIENTS WITH THESE DIFFERENT NEOANTIGENS. SO THIS IS THE TYPE OF RESEARCH THAT WE HOPE TO ACHIEVE, SO THIS IS SORT OF AN IDEAL SITUATION FOR IMMUNOPREVENTION. SO AS FAR AS WHAT WE HAVE GOING ON, AS I MENTIONED, WE ISSUED THE RFA LAST YEAR FOR THE UO1s, SO UNLIKE THE IMMUNOTHERAPY THAT GOT 72 APPLICATIONS, WE ONLY GOT 11 FOR THE IMMUNOPREVENTION. AND THEY ONLY COVERED A LIMITED SUBSET OF SOME OF THESE HIGH RISK COHORTS THAT WE'RE INTERESTED IN TARGETING. SO THE IMPORTANT THING, THOUGH, THAT THERE WAS A LOT OF INTEREST AMONG INVESTIGATORS TO COME IN TO THIS FIELD, THEY JUST DIDN'T FEEL THAT THEY WERE READY OR HAD SUFFICIENT PRELIMINARY DATA FOR A LARGER GRANT. SO WHAT WE'D LIKE TO PROAPSZ TO PROPOSE TO GO ALONG WITH RE-ISSUING THE UO1 AWARDS WO ULD BE THIS PHASED MECHANISM TO BRING PEOPLE WHO ARE INTERESTED IN NEOANTIGEN DISCOVERY BUT BRING THEM INTO THE IMMUNOPREVENTION FIELD. SO THE WAY THESE AWARDS ARE SET UP IS THEY'RE IN TWO PHASES, SO THE FIRST, THE UH2 PHASE, IS TWO YEARS LONG SO YOU CAN APPLY FOR THIS, BUT LIMITED PLIMENT PRELIMINARY DATA. COST OF ABOUT $400,000 DIRECT COST PER YEAR, SO YOU HAVE TWO YEARS TO SORT OF DO A PROOF OF CONCEPT OR IDENTIFY A POTENTIAL TARGET THAT YOU WANT TO DEVELOP FURTHER, AND THEN IF YOU'RE SUCCESSFUL IN THIS APPROACH, THEN YOU CAN APPLY FOR AN ADDITIONAL THREE YEARS OF FUNDING AT THE SAME RATE, AND THAT WILL LET YOU DO THE ACTUAL DEVELOPMENT AND VALIDATION OF ANY VACCINES. SO WE THINK THAT THIS WOULD SORT OF BRING MORE PEOPLE INTO THIS EMERGING FIELD, SO THIS IS THE FIRST CONCEPT THAT WE'RE PROPOSING TO ENHANCE THE NETWORK NETWORK. SECONDLY, WE ARE ALSO PROPOSING TO ESTABLISH THESE IMMUNOENGINEERING IMPROVEMENT, IMMUNOTHERAPY CENTERS OR I3s, THIS COMES FROM THE BLUE RIBBON PANEL BECAUSE WITH THE OVERALL GOAL OF ACCELERATING THE TRANSLATION OF RESEARCH, THERE'S ALSO A FOCUS ON TRYING TO DEVELOP MORE EFFECTIVE, SAFER, MORE BROADLY APPLICABLE IMMUNOTHERAPIES, AND SO MAY HELP US ACHIEVE THIS A LOT QUICKER. SO THE GOAL THEN FOR THESE IMMUNOENGINEERING OR I3 CENTERS WOULD BE TO BRING TOGETHER BIOENGINEERS, CANCER BIOLOGISTS AND POTENTIALLY SYSTEM BIOLOGISTS, AND YOU CAN CREATE THESE MULTIDISCIPLINARY TEAMS, AND THEN THEY COULD USE A VARIETY OF DIFFERENT TOOLS WITH THE END GOAL BEING TO PRODUCE MORE EFFICIENT, SAFER, MORE BROADLY APPLICABLE THERAPIES. SO I HAVE A FEW EXAMPLES OF HOW THIS MIGHT WORK. AND THIS IS JUST SHOWING -- RIGHT NOW CAR T THERAPY IS RESTRICTED BECAUSE OF POTENTIAL GRAFT VERSUS HOST DISEASE, SO THERE'S INTEREST IN MAKING THESE UNIVERSAL CAR T-CELLS WHERE YOU CAN TAKE OUT THE MHC OR THE ENDOGENOUS T-CELL RECEPTOR OR YOU COULD ARM THEM WITH SUICIDE MOLECULES TO REDUCE THE TOX TOXICITY TOXICITY. AND THERE ARE SIMILAR THINGS BEING DONE TO NATURAL KILLER CELLS TO IMPROVE THEIR ABILITY TO INTERACT WITH THE TUMOR. SO THESE KIND OF APPROACHES COULD INCREASE THE APPLICABILITY APPLICABILITY. ALSO, TOO, ONE OF THE LIMITATIONS FOR CAR T IS THAT IT'S A VERY LABORIOUS PROCESS, YOU'VE GOT TO TAKE THE CELLS OUT, YOU'VE GOT TO TRANSECT THEM EX VIVO, SELECT OUT THE CLONES, PUT THEM BACK IN, SO THERE'S ONLY A FEW CENTERS THAT CAN ACTUALLY DO THIS, BUT THIS IS SORT OF A CLEVER IN VIVO NANOPARTICLE APPROACH WHEREBY THESE NANOPARTICLES WOULD HAVE ANTIBODIES THAT TARGET THE T-CELLS IN VIVO SO YOU INJECT THEM AND THEY'RE ALSO CARRYING THIS PAYLOAD WHICH IS THE CDNA ENCODING THE CHIMERIC T ANTIGEN, SO THEY GET TO THE T-CELLS RIGHT IN THE BODY, AND THEY'RE READY TO GO. SO THAT WOULD MAKE THE PROCESS MUCH MORE EFFICIENT. THEN ANOTHER EXAMPLE WOULD BE YOU COULD ACTUALLY USE BIOENGINEERING APPROACHES TO HELP WITH THE VACCINE DEVELOPMENT. SO THERE ARE THESE BIOSYNTHETIC SCAFFOLDS, LACTIC ACID, GLYCOLIC ACIDS, YOU CAN LOAD THEM UP WITH TUMOR ANTIGENS AND GIVE THEM CHEMOKINES SO THEY COME INTO THIS SPONG THAT'S IMPLANTED IN VIVO, THEY GET EDUCATED, THEY MATURE, AND THAT CAN SORT OF AMPLIFY THE MATURATION OF THESE ANTIGEN PRESENTING CELLS. SO THE WAY THAT WE WOULD ENVISION THE BEST WAY TO IMPLEMENT THESE CENTERS WOULD BE USING THIS U54 MECHANISM. SO THIS ALLOWS TO CREATE A CENTER AND WE FEEL THAT IT MAY BE UP TO THREE DIFFERENT PROJECTS, MULTIDISCIPLINARY PROJECTS COULD BE WITHIN ONE CENTER, AND THEN THERE ALSO WOULD BE AN ADMINISTRATIVE CORE FOR EACH OF THESE BECAUSE THAT WOULD ENSURE THAT THESE MULTIDISCIPLINARY TEAMS WOULD ACTUALLY COMMUNICATE WITH EACH OTHER, AND THEN ALSO COMMUNICATE WITH THE OTHER IMMUNOENGINEERING CENTERS THAT MIGHT BE ESTABLISHED, AND THEN TOGETHER, THEY WOULD SORT OF FACILITATE TRANSFER OF TECHNOLOGY OUT TO THE VARIOUS UO1 GRANT HOLDERS WITHIN THE NETWORK. AND WE'RE PROPOSING, AGAIN WE'VE PARTNERED WITH OTHER INSTITUTES IN A TYPE OF CO-FUNDING AGREEMENT, SO WE ANTICIPATE OR WE WOULD LIKE TO FUND ANYWHERE BETWEEN TWO AND FOUR OF THESE CENTERS AT A DIRECT COST OF $1.5 MILLION A YEAR OVER FIVE YEARS. SO THIS IS JUST A SUMMARY THEN OF, AGAIN, HERE'S THE CURRENT ORGANIZATION OF THE IMMUNOTHERAPY CONSORTIUM, AND THEN WE WOULD LIKE TO ADD IN THIS UH2, UH3 PHASED MECHANISM TO BOLSTER RESEARCH IN THE IMMUNOPREVENTION AND THEN ALSO INTRODUCE THESE I3 CENTERS TO SORT OF FACILITATE THE DEVELOPMENT OF THE IMMUNOTHERAPIES AND MAKE THEM MORE EFFICIENT AND MORE EFFECTIVE. AND WE THINK THAT THESE ARE BOTH FAIRLY WELL JUSTIFIED BECAUSE IF YOU LOOK AT THE CURRENT PORTFOLIO OF WHAT'S FUNDED, I'VE MENTIONED A FEW TIMES THAT IMMUNOPREVENTION IS REALLY KIND OF IN ITS INFANCY, SO THERE ARE ONLY SEVEN GRANTS THAT ARE CURRENTLY OUT THERE THAT ARE DIRECTED TOWARDS IMMUNOPREVENTION. ALSO THERE'S A LOT MORE ACTIVITY IN THE IMMUNOENGINEERING OR BIOENGINEERING FIELD BUT IF YOU EXAMINE THESE GRANTS PRETTY CAREFULLY, THEY DON'T EXACTLY FOCUS ON IMMUNOENGINEERING FOR IMMUNOTHERAPY, SORT OF AS WAS ENVISIONED BY THE BLUE RIBBON PANEL. SO WE THINK THIS WOULD BE A NICE ADDITION TO THE NETWORK. THEN OSKT MEASURES OF SUCCESS FOR THESE PROGRAMS WOULD BE ONES OBVIOUSLY BRINGING MORE PEOPLE INTO IMMUNOPREVENTION, IDENTIFYING ADDITIONAL ANTIGENS THAT COULD BE USED FOR DEVELOPMENT OF VACCINES FOR CANCER PREVENTION, AND IMPROVING THE IMMUNOTHERAPIES THAT ARE AVAILABLE, AND THEN GETTING THESE THINGS READY FOR TRANSLATION INTO THE CLINIC. AND THIS IS THE BUDGET FOR BOTH OF THESE NEW INITIATIVES COMBINED, AND SO AGAIN THIS IS THE UH2, SO WE'D PROPOSE TO FUND MAYBE TWO TO THREE OF THESE STARTING IN THE UH2 PHASE, $400,000 DIRECT PER YEAR, AND OVER A FIVE-YEAR SPAN WHERE THEY COULD ROLL INTO THE UH3 PHASE, AND THEN THE U54 I3 CENTERS AT $1.5 MILLION DIRECT FOR EACH CENTER, SO HERE'S THE TOTAL DIRECT COST FOR A YEAR, HERE'S THE TOTAL COST INCLUDING THE ESTIMATED INDIRECT COST AND THIS IS WHAT WE WOULD ESTIMATE THIS WOULD COST OVER THE FIVE-YEAR PERIOD. AND I WOULD BE HAPPY TO TAKE QUESTIONS. >> TERRIFIC. THANK YOU SO MUCH FOR THE PRESENTATION. WE WILL NOW HAVE THE SUBCOMMITTEE COMMENTS, OUR SUBCOMMITTEE MEMBERS WERE SHANNON THOMPSON AND THEN -- WHO'S NOT PRESENT SO I'LL TURN IT OVER TO KEVIN. >> SO I SPOKE WITH DAVID BRIEFLY AND ALSO REVIEWED THIS, AND OBVIOUSLY THIS IS REALLY AN IMPORTANT AREA FOR THE NCI, IMMUNOTHERAPY, AND A LOT OF THIS IS ROLLED OUT MOONSHOT. THE ONE THING WHICH DAVID BROUGHT UP THAT WAS JUST A QUESTION FOR THE PROGRAM OFFICERS WAS -- IS THE INTENT TO HAVE -- TO USE ORGANOID MODELS AT ALL OR ENCOURAGE THE USE OF ORGANOID MODELS WHERE DAVID'S POINT IS YOU CAN TEST DIFFERENT IMMUNE POPULATIONS IN VITRO AND AS SORT OF MORE CONTROLLED AND HIGHER THROUGHPUT SYSTEM. WOULD THAT BE EMPHASIZED IN THE RFA? THAT WAS REALLY THE ONLY POINT THAT CAME UP FROM DAVID. >> ACTUALLY THAT'S SOMETHING WE DO PLAN TO EMPHASIZE FOR THE RFA, BECAUSE THIS SEEKS TO MAKE A MORE EFFICIENT PROCESS. >> I'D LIKE TO CONGRATULATE YOU ON YOUR FLEETNESS IN FOOT IN RESPONDING TO THE SMALL NUMBER OF APPLICATIONS FOR THE IMMUNOPREVENTION. I THINK THAT'S EXTREMELY IMPORTANT, AND SO A VERY NICE RESPONSE TO THAT. THANK YOU. >> IS ONE OF THESE SUPPOSED TO BE INTRAINSTITUTIONAL? IN TERMS OF THESE GRANTS, THEY'RE SUPPOSED TO BE WITHIN ONE INSTITUTION? >> YOU KNOW, THEY CAN BE MULTI-INSTITUTIONAL. YOU MEAN LIKE THE CENTER GRANTS, FOR EXAMPLE? NO, THEY COULD BE MULTI-INSTITUTIONAL. >> I'M SURPRISED IN TERMS OF IMMUNOPREVENTION THAT THERE WOULDN'T BE MORE GRANTS FROM THINGS THAT ARE FOCUSING ON POTENTIAL -- PREMALIGNANT PERCOLATING OF HPV,OR PHARYNX -- >> THERE IS A LOT OF INTEREST IN SECONDARY PREVENTION FOR VIRALLY INDUCED CANCERS BUT AS FAR AS THE SORT OF HIGH RISK GROUPS, THERE'S REALLY NOT A LOT GOING ON THERE, SO THIS IS THE AREA THAT WE'RE REALLY TRYING TO STIMULATE. I THINK THEY WOULD BENEFIT MOST FROM A PREVENTIVE APPROAH. >> I ALSO WANT TO CONGRATULATE YOU ON REALLY CAPTURING A LOT OF WHAT THE CANCER IMMUNOLOGY COMMUNITY NEEDS TO MOVE EVERYTHING TO THE NEXT STEP. I JUST HAD A COUPLE OF COMMENTS JUST TO MAKE SURE YOU'RE THINKING ABOUT SOME OTHER AREAS TO COVER SINCE IT IS MY AREA OF EXPERTISE, SO THE WHOLE CONCEPT OF NEOEPITOPE VACCINES IS WONDERFUL AND I'M CERTAINLY IN THAT FIELD -- THAT SPACE AS WELL. ONE OF THE CHALLENGES IS PREDICTING THE NEOEPITOPES, SO IF YOU WERE ABLE TO BRING PEOPLE TOGETHER AND YOU'VE GOT TO BRING IT FROM THE STRUCTURAL, COMPUTATIONAL BIOLOGISTS AND IMMUNOLOGISTS TO BE THINKING ABOUT THIS, SO IF THIS NEW RFA WERE TO SUGGEST, YOU KNOW, THESE PEOPLE SHOULD APPLY AS WELL FOR THAT AREA BECAUSE I DON'T THINK IT'S GOING TO MOVE OTHERWISE, BECAUSE IT'S NOT THE HIGHEST BINDERS THAT ARE THE ONES YOU WANT TO UTILIZE. SO THAT'S JUST ONE AREA JUST TO MAKE SURE IT'S BEING COVERED. >> AND I PROBABLY DIDN'T EMPHASIZE IT ENOUGH IN THIS PRESENTATION, BUT WE'RE THINKING ABOUT, YOU KNOW, THE PREDICTIVE MODELING, AND THOSE -- >> EXACTLY. >> IT WOULD REALLY BE A NICE COMPLEMENT FOR THE ANTIGEN DISCOVERY. >> AND THERE'S SOME GOOD PEOPLE OUT THERE THINKING ABOUT THIS NOW. AND IN NOVEL WAYS TO DELIVER, SO YOU MENTIONED PEPTIDES AND BIOENGINEERING, ALSO IMPORTANT WILL BE THINGS LIKE ADJUVANTS, WHAT ARE THE BEST ADJUVANTS, BECAUSE WE KIND OF FORGET ABOUT THAT BUT WE REALLY HAVEN'T IDENTIFIED THE BEST WAYS TO DELIVER THESE AND GET THE IMMUNE SYSTEM TO SEE THEM, PROCESS THEM, ET CETERA. AND THEN WITH THE PREVENTION, IMMUNOPREVENTION, I THINK IT'S A REALLY IMPORTANT AREA, WHY DID YOU ELIMINATE SOME OTHER CANCERS SO THERE ARE PEOPLE IN A NUMBER OF DIFFERENT OTHER CANCERS WHO ARE LOOKING AT THIS AS WELL. IS IT POSSIBLE TO OPEN IT UP TO MORE CANCER TYPES? >> I THINK THE INITIAL IDEA WAS TO GO AFTER THESE HIGH RISK GROUPS BECAUSE THAT'S WHERE YOU COULD SEE, YOU KNOW, PROOF OF CONCEPT OF HOW EFFECTIVE THIS MIGHT BE, BUT DEFINITELY ERG THAT COMES OUT OF THAT IS ALSO GOING TO BE PROBABLY APPLICABLE TO SOME OF THE OTHER CANCERS, SO I DON'T SEE ANY REASON WHY IT CAN'T BE EXTENDED. SO >> THERE ARE PEOPLE IN OTHER CANCERS TOO WHO ARE DOING THIS, SO JUST BRINGING IN MORE APPLICATIONS. ONE OTHER THING THAT WE'RE FINDING, THE BIGGEST BARRIER BESIDS THE PREDICTING EPITOPES, IS THE BARRIER TO CLINICAL DEVELOPMENT, SO THERE AREN'T A LOT OF CONTRACTING COMPANIES OUT THERE TO MAKE THESE PEPTIDES, AND JUST TO GIVE YOU AN EXAMPL, WEE DOING THIS GETTING A CLINICAL TRIAL GOING, IT'S ABOUT 50 TO $80,000 A PATIENT FOR FOUR VACCINATIONS OF NEOEPITOPES. YEAH. SO I JUST WANT YOU TO BE THINKING ABOUT THAT, BECAUSE YOU'RE GOING TO HAVE ALL THIS GREAT SCIENCE AND THEN HOW ARE WE GETTING IT TO THE PATIENT. SO THOSE ARE MY COMMENTS. >> GREAT SUGGESTIONS. THANK YOU. >> AND JUST ONE OTHER COMMENT FROM THE PEDIATRIC SIDE OF THE HOUSE, I THINK THAT OBVIOUSLY EMPHASIZING THE ADULT EPITHELIAL CANCERS IS REALLY IMPORTANT, BUT ONE SORT OF EMERGING AREA IN PEDIATRICS IS SINCE THERE ARE VERY LOW MUTATION BURDEN, IS TO TRY TO DISCOVER DEVELOPMENTAL ANTIGENS. SOME OF THOSE MAY ACTUALLY BE APPLICABLE TO SOME OF THE ADULT INITIATED TEU MO AND WONDER IF THE -- NOT NECESSARILY NEOANTIGENS DUE TO MUTATIONAL BURDEN BUT ANTIGENS THAT MAY REPRESENT DEVELOPMENTAL STAGES OF EARLY DEVELOPMENT THAT ARE NOT EXPRESSED ON NORMAL ADULT TISSUES BUT COULD BE GOOD TARGETS. >> WE HAVEN'T SPECIFICALLY OUTLINED THAT, BUT DANA, WERE YOU GOING TO SAY SOMETHING? >> WE DO HAVE THE COMPLEMENTARY PEDIATRIC IMMUNOTHERAPY NETWORK THAT I THINK IS GOING TO BE FOCUSING ON THAT. >> VERY NICE PRESENTATION. ONE OF THE OBSERVATIONS THAT HAVE BEEN MADE IN THE CLINICAL IMMUNOTHERAPY TRIALS -- GLIOBLASTOMA, MOST OF THESE ARE PHASE 1 TRIALS SO THESE ARE HEAVILY PRE-TREATED A PATIENT'S WHO HAVE FAILED EVERYTHING THAT'S AVAILABLE, AND WE GET A SOMEWHAT UNEXPECTED OBSERVATION THAT AFTER THE FAILED IMMUNOTHERAPY, AND THEN LACK OF ANYTHING ELSE TO DO, YOU GIVE THEM THE CHEMOTHERAPY THAT THEY'VE FAILED BEFORE AND THEN THEY SHOW AN INCREDIBLE RESPONSE TO IT. SO I THINK THERE IS AN INTERESTING AREA THAT -- I'M NOT SURE IF IT'S COVERED IN WHAT YOU'RE DOING, THE INTERFACE BETWEEN IMMUNOTHERAPY AND CHEMOTHERAPY, OR OTHER MODALITIES. AS A MATTER OF FACT, RADIATION THERAPY IS -- THERE'S SOME EVIDENCE THAT THAT MIGHT BE THE, THAT -- AND THIS INTRIGUING OBSERVATION IS -- AS A MATTER OF FACT, I'M NOT SURE EVEN IF THOSE WHO OH RESPOND TO IMMUNOTHERAPY FROM HE'S HEAVILY TREATED PATIENTS, MAYBE THE PRE-TREATMENT SET THEM UP FOR BETTER RESPONSE IN IMMUNOTHERAPY. SECONDLY, WHAT WE'RE SEEING IS THAT THE FAILED RADIATION, YOU GIVE IMMUNOTHERAPY, THEY FAIL THAT, YOU GIVE THEM WHAT THEY FAILED TO BEFORE AND THEN THEY RESPOND TREMENDOUSLIMENT I THINK THAT'S AN INCREDIBLE SCIENTIFIC AREA THAT IS GOING TO YIELD AND SET A BASIS FOR FUTURE COMBINATION THERAPY, IMMUNOTHERAPY -- >> THE APPLICATIONS THAT CAME IN FOR THE UO1s FOR THE IMMUNOTHERAPY, THERE WERE QUITE A FEW THAT WERE DEALING WITH THESE COMBINATIONS OR PEOPLE THAT HAVE PREVIOUSLY FAILED SOMETHING WENT BACK ON CHEMO. SO THERE ARE SEVERAL APPLICATIONS THAT CAME IN IN THE LAST ROUND THAT ADDRESS THE ISSUE THAT YOU'RE TALKING ABOUT, AND THEN THIS IS GOING TO BE RE-ISSUED FOR NEXT YEAR AGO AS WELL AND PART OF THE RFA STATES THAT WE'RE INTERESTED IN COMBINATIONS OF DIFFERENT MODALITIES OF THERAPY, AND YOU KNOW, THEN THE DIFFERENT HISTORY OF WHEN THEY'VE BEEN ADMINISTERED, SO HOPEFULLY WE CAN RE-EMPHASIZE THAT AGAIN IN THE RE-ISSUED RFA, BUT WE'RE SEEING A FEW APPLICATIONS AT LEAST ADDRESSING THAT, SO THAT'S A GOOD POINT. >> GREAT PRESENTATION. FOR THE I3 COMPONENT OF THE PRESENTATION, THERE ARE GRADE GRATE NEEDS FOR INFRASTRUCTURE THAT WAS NON-EXISTING. I WAS JUST CURIOUS WHETHER THE BUDGET WILL PERMIT EXPENSES TO GO TOWARDS INFRASTRUCTURE. >> RIGHT. RIGHT NOW WE'RE JUST PROPOSING THE $1.5 MILLION DIRECT. BUT IT'S A GOOD POINT AND I DON'T KNOW IF WE'VE CONSIDERED THERE HAVE TO BE ADDITIONAL FUNDS ALLOCATED FOR THAT. >> [INAUDIBLE QUESTION] >> RIGHT. >> I THINK THERE WILL CERTAINLY BEING A SUPPLEMENT PROGRAM FOR THA KIND OF INFRASTRUCTURE DEVELOPMENT. >> IF THERE ARE NO FURTHER COMMENTS, SO I MOVE THAT WE APPROVE THIS CONCEPT. >> SECOND. >> ALL IN FAVOR OF THE MOTION? OKAY. ANY NAYS? ANY DISSENSIONS? ABSTENTIONS, DISSENSIONS. LATE NIGHT EDITING PAPERS. [LAUGHTER] THE MOTION CARRIES UNANIMOUSLY. THANK YOU VERY MUCH. >> GOOD MORNING. SO OUR INTERSECTION CONCEPT IS IMPLEMENTATION SCIENCE CENTER FOR CONTROL. THIS IS AN RFA, AND DAVID CHAMBERS IS GOING TO BE PRESENTING. DAVID, THANKS SO MUCH FOR COMING. >> SURE. GOOD MORNING, EVERYONE. JUST TO NOTE ON THIS TITLE SLIDE, THIS PRESENTATION REPRESENTS THE WORK OF MULTIPLE CANCER MOONSHOT IMPLEMENTATION TEAMS, SO YOU SEE RIGHT HERE THAT I AM A MESSENGER FOR THREE OF THOSE TEAMS, PREVENTION, EARLY DETECTION, EVIDENCE-BASED APPROACHES, CANCER SEQUENCING -- AND SYMPTOM MANAGEMENT. SO GOING BACK TO WHAT THE WORKING GROUP OF THE BLUE RIBBON PANEL THAT WAS FOCUSING ON IMPLEMENTATION SCIENCE TOLD US, THEY RECOGNIZED THAT WE HAVE A LOT OF EVIDENCE-BASED CANCER CONTROL PROGRAMS, PREVENTION SCREENING, BUT THEY'RE NOT BEING TAKEN UP TO THE EXTENT WHERE THEY'RE REACHING PARTICULARLY UNDERSERVED POPULATIONS. AND IF WE COULD ONLY BETTER IMPLEMENT WHAT'S ALREADY BEEN TESTED, WE COULD AVERT HUNDREDS OF THOUSANDS OF CANCER CASES AND HUNDREDS OF THOUSANDS OF CANCER DEATHS A YEAR. WHAT THE BLUE RIBBON PANEL TOLD US WAS THAT IF WE HAD THAT ROBUST KNOWLEDGE BASE AROUND IMPLEMENTATION STRATEGIES ABOUT HOW WE GET THOSE INTERVENTIONS TO BE TAKEN UP AND SUSTAINED OVER TIME, THAT WE WOULD BE ABLE TO MAKE SIGNIFICANT PROGRESS TOWARDS THIS GOAL. SO JUST ONE SPECIFIC EXAMPLE OF THE EVIDENCE THAT HAS COME FROM A LOT OF THE WORK OF NCI-FUNDED INVESTIGATORS OVER THE YEARS, WE HAVE A RESEARCH TESTED INTERVENTION PROGRAMS WEBSITE THAT WE MANAGE WITHIN OUR IMPLEMENTATION SCIENCE TEAM. JUST ON THAT ONE WEBSITE, WE HAVE ALMOST 200 EVIDENCE-BASED INTERVENTION PROGRAMS COVERING DIFFERENT ASPECTS OF CANCER CONTROL AND THIS IS JUST A SUBSET OF WHAT THE FIELD HAS BEEN ABLE TO DEVELOP. BUT IF WE REALLY WANT TO SEE THAT WE'RE HAVING POPULATION IMPROVEMENT, IT'S GOING TO COME FROM OUR ABILITY TO SHIFT FROM WHAT DO WE DO FOR THIS INDIVIDUAL PATIENT TO HOW DO WE GET THOSE INTERVENTIONS TO BE TAKEN UP TO BE SUSTAINED OVER TIME, SO WHAT THIS QUICK SKETCH WHICH COMES FROM A PAPER FROM 2009 THAT WE HAD DEVELOPED IS TO EMPHASIZE THAT IT'S NOT JUST ABOUT WHAT DO WE DO, BUT IT'S WHAT ARE THE CONDITIONS THAT ENABLE OUR COMMUNITIES, OUR SERVICE SYSTEMS, OUR OH HEALTHCARE SETTINGS TO BE ABLE TO DELIVER THOSE INTERVENTIONS. WE HAVE KEY IMPLEMENTATION OUTCOMES THAT SAY HAVE WE BEEN SUCCESSFUL IN GETTING THESE INTERVENTIONS TO BE TAKEN UP, ARE THEY FEASIBLE, ARE THEY SUSTAINED OVER TIME, WHAT ARE THE COSTS ASSOCIATED WITH BRINGING THOSE PRACTICES INTO OUR HEALTHCARE AND OUR COMMUNITY SETTINGS. THE ARGUMENT IS THAT IF WE GET IMPLEMENTATION RIGHT, WE GET IMPROVEMENTS BROADLY IN THE SERVICES WE'RE ABLE TO PROVIDE TO OUR POPULATION, THEN YOU SEE ON THE RIGHT END, THAT WE'RE NOT ONLY ABLE TO MOVE HEALTH OUTCOMES ONE PERSON AT A TIME, BUT THAT WE'RE REALLY ABLE TO DRIVE IMPROVEMENTS TO OP LAITION LAITIONS. SO USING THE CLEVER USE OF ANIMATION, YOU CAN SEE THIS SPECIFIC GRAPHIC EMPHASIZES THAT WE'RE REALLY FOCUSING ON HOW DO WE GET THESE INTERVENTIONS TO BE TAKEN UP. SO THE BLUE RIBBON PANEL GAVE US THAT CHARGE, AND OVER THE LAST YEAR, ACROSS THESE THREE DIFFERENT GROUPS, WE'VE BEEN THINKING ABOUT WHAT ARE SOME TARGETED WAYS TO START MOVING THE DIAL. SO ONE OF WHICH YOU HEARD ALL OF THESE LAST YEAR AT THIS TIME, ONE OF WHICH WAS SPECIFICALLY FOCUSING AROUND COLORECTAL CANCER SCREENING, FOLLOW-UP AND REEFL TO CARE, REFERRAL TO CARE, WHAT ARE THE STRATEGIES THAT ARE GOING TO IMPROVE UP TAKE TO CANCER SCREENING RELATIVE TO UNDERSERVED" AND YOU HEARD ABOUT A THIRD RFA THAT WAS FOCUSING ON HOW DO WE DO BEATER JOB OF BRINGING THE EVIDENCE BASE AROUND HEREDITARY CANCERS TO THE POPULATION HEALTH BENEFIT. AT THE SAME TIME, THROUGH TARGETED SUPPLEMENTS TO CANCER CENTERS, WE'VE BEEN ABLE TO REALLY TRY AND IMPROVE IMPLEMENTATION OF TOBACCO CESSATION AND WE'VE BEEN ABLE TO ISSUE TWO ROUNDS OF THOSE SUPPLEMENTS AND WE'VE ALSO BEEN WORKING WITH CANCER CENTERS AROUND HOW DO WE BETTER UNDERSTAND THE LOCAL FACTORS AFFECTING WHETHER THE HPV VACCINATION CAN BE TAKEN UP WITHIN THE COMMUNITIES. SO WE'VE BEEN ABLE TO DO A LOT AND SO IT'S ENABLED UTION NOW US NOW TO SAY WHAT IS THAT NEXT STEP THAT ISIDEALLY GOING TO BUILD ON ALL OF THESE ACTIVITIES? SO AS WE LOOKED AT WHAT ARE WE CURRENTLY DOING IN IMPLEMENTATION SCIENCE AND WHAT IMPORTANTLY ARE WE NOT DOING, WE IDENTIFIED THESE KEY NEXT STEPS THAT WOULD REALLY BUILD ALL OF THE WORK THAT HAS BEEN GOING SO FAR THROUGH MOONSHOT. SO ONE OF THOSE IS, COULD WE HAVE ONGOING SORT OF CLINICAL AND COMMUNITY SITES THAT ARE GATHERED TOGETHER TO FORM OUR IMPLEMENTATION LABORATORIES, SO THE LABORATORIES TO STUDY IMPLEMENTATION ARE COMMUNITY AND CLINICAL SITES THAT ARE READY TO BE ABLE TO EVALUATE ALL OF THESE ONGOING EFFORTS TO TRY AND IMPLEMENT EFFECTIVE PRACTICES. WHAT WE DON'T CURRENTLY HAVE RIGHT NOW, WE COULD BENEFIT FROM, WOULD BE THE IDEA OF A WHOLE RANGE OF DIFFERENT NATURAL EXPERIMENTS, RAPID CYCLE TESTING THAT IN SOME CASE WE'RE NOT GETTING THROUGH OUR TYPICAL R01 ANNOUNCEMENTS. THE DEVELOPMENT OF A WHOLE RANGE OF DIFFERENT VALID RELIABLE AND PRAGMATIC MEASURES TO FILL GAPS IN TERMS OF WHAT ARE THE OUTCOMES AROUND IMPLEMENTATION SCIENCE THAT WE DON'T NECESSARILY HAVE THE RIGHT MEASURES, AN EASIER WAY TO TRY AND GENERATE PILOT STUDIES, PARTICULARLY IN AREAS OF IMPLEMENTATION SCIENCE, WE'RE NOT SEEING AS MUCH. SO THINKING ABOUT PRECISION MEDICINE BUT THINKING ABOUT HOW DOES THAT GET IMPLEMENTED WITHIN THE CLINIC, THINKING ABOUT DEIMPLEMENTATION, HOW DO WE STOP DOING THINGS THAT WE KNOW TO BE NOT AS EFFECTIVE OR EVEN HARMFUL, HOW DO WE BETTER UNDERSTAND ABOUT HOW INTERVENTIONS ARE TAILORED OR ADAPTED LOCALLY TO BE OPTIMIZED, AT LEAST THE FIT BETWEEN THOSE INTERVENTIONS AND THE COMMUNITY, HOW DO WE THINK MORE MECHANISTICALLY ABOUT IMPLEMENTATION STRATEGIES. AT THE SAME TIME, WE RECOGNIZE THE NEED FOR BROADER SUPPORT FOR THE COUNTRY IN TERMS OF IMPLEMENTATION SCIENCE IN CANCER CONTROL. THE IDEA THAT ANNUAL MEETINGS SPECIFICALLY FOR CANCER CONTROL IMPLEMENTATION MIGHT HELP, TRAINING AND MENTORING SUPPORT, VARIOUS WAYS IN WHICH WE CAN TRY AND MORE RAPIDLY ADVANCE UPON WHAT'S ALREADY GOING ON. COLLABORATIVE WORK SPACE FOR INNOVATIVE STUDY CONCEPTS. SO IN TRYING TO ADDRESS THESE CURRENT NEEDS, WE THOUGHT THAT THIS WAS A PERFECT TIME TO BE THINKING ABOUT SPECIFICALLY IMPLEMENTATION SCIENCE CENTERS FOR CANCER CONTROL. THE GOAL OVERALL IS TO REALLY SCALE UP THE IMPLEMENTATION SCIENCE EFFORTS ACROSS MOONSHOT, AS WELL AS WHAT'S BEEN GOING ON WITHIN THE BROADER FIELD, INCLUDED WITHIN EACH CENTER IS A SPECIFIC ADMINISTRATIVE CORE THAT SHOWS HOW THE CENTER IS GOING TO FUNCTION. AT THE CORE OF THESE CENTERS IS THIS IDEA OF ESTABLISHED COLLABORATION WITH HEALTH AND COMMUNITY SYSTEMS TO FORM THESE NATURAL LABORATORIES WHERE WE CAN STUDY IMPLEMENTATION IN VIVO, ONCOLOGY SETTINGS, PRIMARY CARE, COMMUNITY SETTINGS FOR EXAMPLE, THAT EACH THESE CENTERS WOULD HAVE SPECIFIC FOCUS ON ADVANCING MEASUREMENT AND METHODS TO DEAL WITH THE COMPLEX PHENOMENA OF HOW WE IMPLEMENT THINGS AS THE SETTINGS ARE CHANGING OVER TIME THAT THEY WOULD HAVE A SET OF INNOVATIVE RESEARCH PILOTS AND IMPORTANTLY THAT EACH CENTER WOULD HAVE A NETWORK CORE WITH THE IDEA THAT OVERALL, THE PROGRAM WOULD PERMIT INCREASED CAPACITY FOR THE FIELD, SO A PROGRAM-WIDE IMPLEMENTATION SCIENCE CONSORTIUM, HOSTING ANNUAL MEETINGS, THINKING ABOUT HOW DO WE DISSEMINATE THE FINDINGS FROM PILOTS, HOW DO WE ADVANCE THEM INTO LARGER STU DIDZ, HOW DO WE PROVIDE TRAINING OPPORTUNITIES FOR THE FIELD. SO ONE EXAMPLE OF THIS, IF WE THINK ABOUT THE FIT BETWEEN OUR INTERVENTIONS AND OUR SETTINGS, WE RECOGNIZE THAT AS DIFFERENT COMMUNITY AND CLINICAL SETTINGS ARE TRYING TO TAKE THESE PROGRAMS OFF THE SHELF, THEY'RE FINDING THAT THERE CAN BE A MISMATCH, SO THEY'RE IN VERY CRUDE WAYS FIGURING OUT HOW DO I ADAPT THIS INTERVENTION SO IT CAN BE IMPLEMENTED AND ACTUALLY REACH THE PATIENT POPULATION THAT I'M TRYING TO GET TO. IF I WERE GOING TO THINK ABOUT AN IMPLEMENTATION SCIENCE CENTER THAT'S SPECIFICALLY FOCUSED ON INTERVENTION ADAPTATION, HERE'S AT LEAST ONE CUT OF HOW IT MIGHT LOOK LIKE. I WOULD HAVE SPECIFIC METHODS AND MEASUREMENT PROJECTS THAT ARE HELPING ME UNDERSTAND HOW DO I MEASURE HOW THESE INTERVENTIONS ARE BEING ADAPTED OVER TIME, HOW DO I USE REALTIME DATA CAPTURE TO BETTER UNDERSTAND WHERE DIFFERENT INTERVENTIONS ARE BEING TAILORED FOR DIFFERENT POPULATIONS. IF I'M THINKING ABOUT INNOVATIVE RESEARCH PILOTS, I WOULD BE THINKING ABOUT IS IT POTENTIAL TO USE TECHNOLOGY AS TO HOW I'M ADAPTING THESE DIFFERENT INTERVENTIONS, ARE THERE WAYS IN WHICH I MIGHT USE NATURAL LANGUAGE PROCESSING TO IDENTIFY KEY INFORMATION FROM ELECTRONIC HEALTH RECORDS THAT MIGHT THEN GET ME A BETTER SENSE OF HOW ARE THESE INTERVENTIONS BEING ADAPTED AND HOW MIGHT I MORE RATIONALLY FIGURE OUT THE RIGHT WAY TO CUSTOMIZE THESE INTERVENTIONS SO THEY REACH THE POPULATION. I MIGHT BE THINKING ABOUT A WHOLE SET OF PRIMARY CARE PRACTICES IF I'M THINKING ABOUT SCREENING OR CANCER PREVENTION, AND THE IDEA THAT THERE'S A COMMON ELECTRONIC HEALTH RECORD LEADERSHIP BUY-IN INTEREST WITHIN THESE SETTINGS IN TRYING TO FIGURE OUT THE BEST WAY TO TAILOR INTERVENTIONS SO THEY CAN BE DELIVERED IN PRACTICE AND A RANGE OF NATURA EXPERIMENTS THAT I CAN EXPLOIT. AND THEN MY NETWORK CORE IS REALLY FOCUSING ON HOW DO I DISSEMINATE THE FINDINGS, HOW DO I CONNECT WITH A LOT OF THE ONGOING MOONSHOT GRANTEES AND WHAT ROLE MIGHT I PLAY AS ONE OF A COUPLE OF CENTERS IN THINKING ABOUT HOSTING LARGER EFFORTS FOR THE FIELD, SHARING TOMBS, TOOLS, TRAINING ACROSS THE FIELD AND PROVIDING TRAINING OPPORTUNITIES. SO WHAT DOES THIS LOOK LIKE TO WHAT WE'VE ALREADY DONE IN MOONSHOT, ACCESS HAS BEEN TRYING TO PROVIDE A NUMBER OF PROSPECTIVE TRIALS, STRATEGIES TARGETING COLORECTAL CANCER SCREENING AND FOLLOW-UP. IMPACT HAS BEEN PROSPECTIVE TRIALS FOCUSING ON IMPROVEMENT OF IMPLEMENTING SYMPTOM MANAGEMENT. THE HEREDITARY CANCERS HAS AGAIN BEEN ABOUT PRO PROSPECTIVE TRIALS, GENETIC RISK FACTORS AND FORESHA DOAG WHAT YOU'RE GOING TO HEAR IN JUST A LITTLE BIT, WE HAVE OTHER ACTIVITIES TRYING TO FIGURE OUT HOW DO WE DO A BETTER JOB OF IMPROVING ENGAGEMENT IN CLINICAL TRIALS OTHER RESEARCH STUDIES. THIS CENTER ANNOUNCEMENT IS INTENDED TO TRY AND CAPITALIZE ON ALL OF THESE. THE IDEA THAT WE WOULD BE CREATING A FIELD WIDE CONSORTIUM TO LEARN FROM ONE ANOTHER, THE IDEA WE WOULD BE STANDING UP NATURAL LABORATORIES OF IMPLEMENTATION, THE IDEA THAT WE WOULD HAVE MUCH MORE FLUID, MUCH MORE RAPID PILOT STUDIES AND THAT WE WOULD HAVE ADVANCES IN MEASUREMENT DEVELOPMENT THAT WOULD REALLY CUT ACROSS ALL OF THEETS AREAS. JUST TO SAY THAT THIS IS ALSO TRYING TO LEVERAGE THE CANCER CENTER SUPPLEMENTS, NCOR AS A POTENTIAL PLATFORM FOR COMMUNITY ONCOLOGY THAT WE WOULD WANT TO LEVERAGE AS WELL AS OUR STANDING TRANS-NIH PROGRAM ANNOUNCEMENTS ON DISSEMINATION AND IMPLEMENTATION THAT BEEN MORE FOR THE LARGER SORT OF FULLY BAKED R01 IMPLEMENTATION TRIALS. SO IN SUMMARY, WHAT WE WOULD BE LOOKING FOR IS FOUR TO FIVE RESEARCH CENTERS, EACH WOULD HAVE THIS IMPLEMENTATION LABORATORY, CORES TO TRY TO ESTABLISH MORE METHODS AND MEASUREMENT DEVELOPMENT, AS WELL AS NETWORKING ACROSS THE FIELD, PILOT IMPLEMENTATION STUDIES, REALLY FOCUSING ON COMMON DATA ELEMENTS THAT EMERGE ACROSS THE FIELD AND HOW CAN WE BUILD THIS BY CONSORTIUM, WE SEE THE POTENTIAL BENEFIT BECAUSE THERE ARE CERTAIN AREAS OF IMPLEMENTATION SCIENCE WHERE WE'VE HAD A LOT MORE ACTIVITY OF ADDING ADVANCED CENTERS IN THOSE ESTABLISHED CENTERS, CANCER SCREENING SYMPTOM MANAGEMENT, BUT ALSO ENABLING FOR MORE INNOVATIVE, MORE NIMBLE SMALLER DEVELOPING CENTERS IN AREAS WHERE WE REALLY HAVEN'T SEEN NEARLY AS MUCH, AND THIS IS OUR CHANCE TO TRY AND ADVANCE IMPLEMENTATION SCIENCE. SO WE THINK ABOUT PRECISION MEDICINE OR DEIMPLEMENTATION AS ONE OF THOSE EFFORTS. OVERALL, WE WOULD SEE THE POTENTIAL TO HAVE THREE OF THESE ADVANCED CENTERS, THIS IS TOTAL COSTS AT 2 MILL YONDZ PER YEAR, TWO OF THESE DEVELOPING CENTERS, $1 MILLION TOTAL COST, SO THAT WOULD GIVE US FOR THE FIRST YEAR, $8 MILLION TOTAL KUCINICHS FOR THE BUDGET WHICH OVER THE YEARS WOULD -- WE VERY MUCH APPRECIATE THEIR GREAT FEEDBACK AND HERE'S JUST A SUMMARY OF SOME OF THE DISCUSSION THAT WE HAD ON HOW WE'RE THINKING ABOUT RESPONDING. SO THEY TOLD US THAT IT WOULD BE HELPFUL TO HAVE MUCH MORE EXPLICIT EXPECTATIONS OF HOW THESE CENTERS ARE ORGANIZED ADMINISTRATIVELY, PARTICULARLY TO PERMIT SORT OF INTEROPERABILITY. IF EACH OF THE CENTERS HAS A SPECIFICALLY MEASUREMENT AND METHODS CORE, THEN WE CAN SEEING A SEEING A GATING THE WORK EACH CENTER IS DOING FOR THE FIELD. ANOTHER RECOMMENDATION OF MOONSHOT WHICH IS THE CANCER DATA ECOSYSTEM AND WHATS WHAT DOES THAT LOOK LIKE FOR IMPLEMENTATION. FOR US WE'RE THINKING ABOUT PUSHING FOR COMMON DATA ELEMENTS BEING REQUIRED, TARGETED DEVELOPMENT OF KEY MEASURES THAT THEN COULD BE EXPANDED TO THE ONGOING IMPLEMENTATION SCIENCE TRIALS BUT ALSO FOR THE BROADER FIELD IN GENERAL. THEY ASKED US TO CONSIDER WHAT DO WE EXPECT OF INDIVIDUAL CENTERS TO DO IN ISOLATION VERSUS WHAT'S EXPECTED OF THE CONSORTIUM. IF WE THINK ABOUT OUR EARLY STAGE INVESTIGATORS, WE SEE FEUNTS FOR THOSE INVESTIGATORS TO BE INVOLVED IN THE THEMATIC PROJECTS, THE STUDIES WITHIN THE INDIVIDUAL CENTERS. IN TERMS OF BROADER FIELD TRAINING OR OPPORTUNITIES FOR NEW INVESTIGATORS, THAT'S WHERE WE SEE THAT LARGER CONSORTIUM COMING IN AND THINKING ABOUT HOW WE CAN BUILD BROADER CAPACITY FOR THE FIELD. THEY ASKED US TO CLARIFY THE NUMBERS AND TYPES OF PILOTS SO YOU CAN SEE THE PILOTS IN TERMS OF SCALE. THE MEASUREMENT ONES ARE GOING TO LOOK MORE LIKE RO3s, THE SORT OF INNOVATIVE PILOT STUDIES OF IMPLEMENTATION STRATEGIES ARE GOING THROOK MORE TO LOOK MORE LIKE R21s. WE SET AS A BOTTOM THRESHOLD FOUR OF THOSE TO BE PROPOSED IN ADVANCED CENTERS, TWO IN DEVELOPING CENTERS BUT MORE IF THEY HAVE THE BUDGET FOR THEM. THEY WANTED MORE DISTINCTION BETWEEN THIS DEVELOPING AND ADVANCED CENTER IDEA, IT'S SCALE OF THE LABORATORY THAT THEY'RE ABLE TO SET UP, IT'S THE SCALE OF THE NETWORK THAT THEY'RE TRYING TO REACH OUT TO, AND IMPORTANTLY, IT'S THE SCIENTIFIC FOCUS, SOME MAY NOT BE READY FOR AS LARGE EAFNT AS OAMPLETS AN EFFORT AS OT HERS. WE'RE LUCKY TO HAVE AN IMPLEMENTATION TEAM, HOW CAN WE PROMOTE DATA SHARING, HOW CAN WE PROMOTE DISSEMINATION OF ALL OF THE FINDINGS, AND HOW CAN WE SUPPORT SOME OF THE MEETINGS, SOME OF THE GATHERINGS OF FOLKS TOGETHER. SO LAST THING THAT I'LL SAY IN ADDITION TO THANKING THE BSA SUBCOMMITTEE AND ALL OF YOU IS TO THANK THE CO-CHAIRS OF THE THREE DIFFERENT IMPLEMENTATION TEAMS, SPECIFICALLY TO MENTION APRIL OWENS, CINDY VINCENT WHO HAVE BEEN INSTRUMENTAL IN ADVANCING THOUGHTS I'VE SHARED WITH YOU ALONG WITH OUR LEADERSHIP AT DCCPS AND OUR IMPLEMENTATION SCIENCE TEAM. SO THANK YOU. [APPLAUSE] >> DAVID, THANKS SO MUCH FOR YOUR EXCELLENT PRESENTATION AND ALSO FOR ALL OF YOUR EFFORTS TO ADVANCE THIS FIELD AT NCI. WE HAVE A SUBCOMMITTEE WITH DR. EVANS AS CHAIR, DR. I'LL HAND IT OVER TO YOU. >> THANK YOU. SO I JUST WANT TO AS A WAY OF BACKGROUND SAY THAT NCI HAS REALLY BEEN A LEADER IN DEVELOPING THE FIELD OF IMPLEMENTATION SCIENCE AND SHOULD BE VERY PROUD OF THAT. WE'VE BENEFITED SO MUCH IN HOW WE KNOW, WHAT WE DO. HOW DO WE MOVE AS WE HAVE DISCOVERIES, HOW DO WE MOVE THEM INTO PRACTICE FOR EVERYBODY, AND HOW DO WE THINK ABOUT THE DISCOVERIES THAT ARE COMING DOWN THE PIKE WHERE WE MAY ACTUALLY ENHANCE DISPARITIES RATHER THAN TAMP DISPARITIES DOWN, SO THIS IS ABSOLUTELY ESSENTIAL TO THE WHOLE CANCER CONTINUUM IN MY VIEW, SO I THINK THIS IS JUST REALLY, REALLY IMPORTANT, AND BECAUSE OF ALL THIS GROUNDWORK AND VERY STRATEGIC THINKING THAT DAVID LAID OUT, WE ARE REALLY AT A MOMENT WHERE THERE'S ENOUGH CRITICAL MASS TO BE ABLE TO DO THIS IN A WAY THAT WILL CATAPULT THE FIELD FORWARD EVEN MORE, SO I THINK THIS IS JUST REALLY THE RIGHT MOMENT FOR THIS KIND OF WORK. WE HAD A REALLY GOOD COMMITTEE DISCUSSION WITH DAVID AND HIS TEAM. I'M NOT GOING TO GO OVER THE FEEDBACK IN DETAIL BECAUSE DAVID JUST DID THAT IN LARGE PART. SOME OF OUR -- A FEW HIGHLIGHTS. SOME OF OUR COMMENTS WERE REALLY ABOUT THE STRUCTURE AND HAVING A LITTLE MORE SPECIFICITY. I THINK ORIGINALLY YOU WERE THINKING LET'S SEE WHAT COMES TO US, BUT BECAUSE YOU WANT THIS TO BE SO INTERCONNECTED, GIVING MORE STRUCTURE WILL HELP PEOPLE REALLY SET YOU UP WELL FOR THAT. SO THEY'VE BEEN VERY RESPONSIVE TO THAT, BRINGING IN AN ADMIN CORE, DEFINING PILOTS MORE, SO I THINK THAT WILL BE EXTREMELY HELPFUL TO THE INVESTIGATORS AS THEY TRY TO WRITE THIS. IT'S A VERY DIFFERENT KIND OF MECHANISM FOR US, SO I THINK THAT WILL BE VERY HELPFUL. A COUPLE THINGS WE DISCUSSED AND I THINK WILL PROBABLY COME IN TO THE RFA BUT ARE WORTH BRINGING UP HERE IS A REALLY IMPORTANT OPPORTUNITY IS TO THINK ABOUT POLICY IMPLEMENTATION. I THINK IT'S PRETTY CLEAR THAT IF WE'RE GOING TO REALLY ADDRESS CANCER DISPARITIES, WE HAVE TO MOVE TOWARDS HELPING OUR LOCAL, STATE AND FEDERAL GOVERNMENTS THINK MORE ABOUT HOW WE GIVE ACCESS AND POLICY IS GOING TO BE A HUGE PART OF THAT SO I THINK THAT'S A HUGE AREA, IT'S VERY OPEN AND SOMETHING THAT I HOPE WILL COME IN TO THIS EFFORT THE. WE ALSO WERE. WE ALSO WERE A LITTLE CONCERNED ABOUT THE ADVANCED DEVELOPING CENTERS IN TERMS OF THE SIZE OF THIS. THERE'S A TOTAL COST CAP ON THIS. I HAVE TO SAY JUST AT THE NCI LEVEL, I CONTINUE TO BE CONFUSED ABOUT WHEN TOTAL COST CAPS ARE USED AND WHEN DIRECT COST CAPS ARE USED. IN THE CONCEPT THAT WAS JUST PRESENTED, BEFORE IT -- I'M VERY CONFUSED ABOUT THAT AND THINK IT WOULD BE WORTH HAVING SEPARATE DISCUSSION ABOUT THAT. WE WANTED FLEXIBILITY SO IF THERE ARE SEVERAL ADVANCED CENTERS COMING IN THAT WERE REALLY STRONG, MAYBE NOT DOING DEVELOPING CENTERS IF THOSE ARE WEAKER, VICE VERSA. IT SOUNDED LIKE NCI WOULD HAVE THAT FLEXIBILITY SO WE WOULD STRONGLY ENCOURAGE THEM TO BUILD THAT IN SO THAT THEY'RE ABLE TO DO THAT. THINK THOSE ARE MY COMMENTS. OTHER COMMITTEE MEMBERS MAY WANT TO ADD OTHER THINGS OR AMPLIFY. >> OKAY. GRAHAM? >> SO AGAIN, FANTASTIC TO BE MOVING TO THE NEXT LEVEL HERE. THE POTENTIAL OPPORTUNITY AS KAREN HAS DESCRIBED TO GO BEYOND THE PREVENTION AND CONTROL EXAMINED TO THERAPY THAT'S BEING GUIDED BY GENOMIC TESTING, THERE ARE LOTS OF PLACES THAT THESE SAME PRINCIPLES APPLY AND AS WE GO FORWARD AS THE CENTERS -- THE BROADER COLLECTION OF CANCER CENTER LEADERSHIP AND ONGOING ACTIVITY, I THINK IS KEY. YOU POINTED TO THE HPV AND TOBACCO CONTROL AS EXAMPLES, BUT THEY'RE VERY MUCH ON PREVENTION AND THE IMMUNE MONITORING MAY BE, IN FACT, AN EXAMPLE THAT'S MORE ON THE DEVELOPING THERAPY PEW TICK END, BUT HOW DO WE MAKE SURE THESE ALL TALK TOGETHER THROUGH THIS WHOLE PROCESS. BUT OTHER OH WISE, I THINK IT'S REALLY AN IMPORTANT NEXT STEP. >> >> THE KE KEY QUESTION HOW TO CLOSE THE GAP IS AN URGENT ONE. FOLLOWING THE COMMENTS WE JUST HEARD AS WELL AS THE COMMENTS YESTERDAY, I THINK THAT THIS IS HEADED IN THE RIGHT DIRECTION AND THERE ARE TWO AREAS WHERE HE'D ENCOURAGE YOU TO PUSH IT A LITTLE FASTER. ONE IS THE DATA ECOSYSTEM. IN THIS IS STANCE OF HOW TO CLOSE THE GAP AND GET CONSISTENCY, COMMITMENT TO DATA SCIENCE CAN BE A KEY ENABLER, SENDS A MESS ANL THAT, MESSAGE THAT YES, T HERE IS A WAY TO DO IMPLEMENTATION, NOT EVERY GROUP HAS TO NECESSARILY REINVEST THINGS SO I'D ENCOURAGE YOU TO LEVERAGE THAT KEY ASSET. THE SECOND PART, THIS IS, I HOPE, A SAFE SPACE FOR BIG IDEAS. THINK OF HOW SUCCESSFUL THE NIH HAS BEEN IN PUSHING DATA SHARING BY MAKING THAT A CORE COMPONENT. NOW WE'RE AT A POINT WHERE IMPLEMENTATION IS GOING TO BE AN ISSUE. WHAT ARE THE IMPLEMENTATION PLANS, WHAT ARE THE POTENTIAL BARRIERS YOU'RE GOING TO SEE. I THINK WE'RE GETTING CLOSER TO THAT POINT WHERE WE KNOW THAT'S COMING AND IF NIH AND NCI CAN START TO ASK APPLICANTS IN PROJECTS HOW ARE YOU GOING TO DEAL WITH THAT, THEN I THINK THAT WOULD HELP ADVANCE THE OVERALL GOALS. OVERALL, GREAT CONCEPT, I THINK IT WILL BE A KEY STEP FORWARD. THANKS FOR THE PRESENTATION. >> THANKS SO MUCH. JUST BEFORE WE TAKE COMMENTS, ONE OF THE QUESTIONS THAT KAREN RAISED WAS ABOUT TOTAL VERSUS DIRECT COST CAPS WITHIN DIFFERENT PROPOSALS. YOU MAY NOT BE IN A POSITION TO COMMENT MORE GLOBALLY BUT PERHAPS WE CAN TALK ABOUT THAT FOR A MOMENT BECAUSE IT ACTUALLY HAS COME UP IN SEVERAL OF THESE CONCEPTS. >> OBVIOUSLY IT'S NOT EXCLUSIVE IT TO THIS PARTICULAR PROPOSAL, SO DEAN, I DON'T KNOW IF YOU WANTED TO MAKE THE MORE GENERAL COMMENT OR NED OR -- >> SO IN GENERAL, WE USE THE DIRECT COSTS IN THE PUBLISHED RFA FOR THE P.I. TO KNOW WHAT THE CAP IS THAT THEY CAN ASK BUT, IN FACT, WHAT IT COST OHS THE NCI IS THE TOTAL COST BECAUSE OF THE INDIRECTS TO THE DIFFERENT INSTITUTIONS, SO WHEN WE PRESENT THIS TO YOU OR WITHIN THE NCI, WE GIVE BOTH THE DIRECT COST WHICH IS RELEVANT TO THE P.I. AND THEN THE TOTAL COST WHICH IS RELEVANT TO NCI AND TO THE BSA FOR WHAT IT'S ACTUALLY GOING TO COST. BECAUSE THE INDIRECT COSTS ARE DIFFERENT FROM INSTITUTION TO INSTITUTION, WE CAN'T PUBLISH THAT BECAUSE THAT'S NOT HELPFUL TO YOU. >> SO IN THE PREVIOUS PRESENTATION, THEY DID PULL OUT DIRECT COSTS SO JUST TO HAVE APPLES TO APPLES, IT WOULD BE HELPFUL TO -- I DON'T KNOW HOW TO DO THE MATH TO GO BACKWARD, YOU MUCH HAVE A WEIGHTING -- >> I THINK THIS IS ONE OF THOSE THINGS, THIS IS ONE OF THESE THINGS WHERE INSIDESIDE THE FEDERAL GOVERNMENT, IT IS VERY EASY TO CONVERT BETWEEN THESE TWO NUMBERS BUT IT MIGHT BE CONFUSING TO PEOPLE WHO DON'T DO THIS EVERY DAY. THERE'S HEMOGLOBIN AND HEMATOCRIT TO A HEMATOLOGIST. SO PROVIDING BOTH DIRECT AND TOTAL, TOTAL IS ACTUALLY THE NUMBER YOU SHOULD PAY ATTENTION TO WENT DIRECT IS WHAT THE P.I.s SHOULD LOOK TO WHEN THEY'RE WRITING THEIR GRANT. FROM THE NCI POINT OF VIEW, AS THEIR MISSION IN THIS JOB, YOU'RE WATCHING TOTAL COSTS. >> DO THEY HAVE YOU HAVE IN MONEY FOR THESE CENTERS TO DO WHAT THEY'RE ASKING TO DO? SCOPE ON THIS IS PRETTY DARN BIG, SO THAT'S WHAT WE WERE WORRIED ABOUT, IS THERE ENOUGH TO REALLY PULL OFF THIS. >> THAT'S A DIFFERENT -- ISSUE. >> THE P50 CENTERS ARE $2 MILLION TOTAL EACH, PER YEAR. THE SCOPE IS REALLY LARGE FOR THAT AMOUNT OF BUDGET. IT REALLY IS LARGE. I THINK YOU'RE GOING TO HAVE TO RE-THINK EITHER THE SCOPE OR THE AMOUNT OF MONEY PER CENTER. >> SO DR. CHAMBERS, THAT WAS A PHENOMENAL PRESENTATION. SEVERAL OF US ARE THINKING A VERY SIMILAR THOUGHT WHICH IS, AS I THINK ABOUT THE TWO STAINLS OF CENTERS THAT YOU HAVE, I THINK WOULD MY CANCER CENTER BE ABLE TO COMPETE? PROBABLY NOT, BUT WHAT WE COULD BRING OUR HUGE NETWORKS OF PRIMARY CARE CLINICS IN DEEP RURAL SETTINGS WITH MASSIVE DISPARITIES AND VERY UNIQUE POPULATIONS, SO I WONDER AS YOU THINK ABOUT THE RFA IS YOU ACTUALLY START WITH THOSE KIND OF BIG CENTERS AT FIRST WHO PROBABLY HAVE SOME MORE EXPERIENCE AND EXPERTISE IN THE IMPLEMENTATION SCIENCE AND MAYBE I AGREE WITH ALL THE COMMENTS ABOUT SETTING SOME AREAS OF CONCENTRATION. I LOVE THE PRECISION MEDICINE ONE, I SAT HERE YESTERDAY THINKING ABOUT HOW IS A CENTER LIKE OURS IN A REALLY POOR STATE GOING TO DELIVER NEW NEOANTIGEN-BASED IMMUNOTHERAPY VACCINES? WHY SHOULDN'T MOST PEOPLE HAVE THE SAME ETHICAL RIGHT TO THAT TREATMENT? SO THE ONLY WAY TO REALLY DO THAT IS COLLABORATION. SO WHAT I WAS THINKING IS, IF YOU FOCUS ON LARGER CENTERS AND SORT OF FORM SOME CONCEPTS AROUND PRECISION MEDICINE OR VACCINATION AND SCREENING WHICH WE'RE ALL STRUGGLING WITH, AND I LOVE THE IMMUNOSCREENING AND PREVENTION, AND THEN YOU THINK ABOUT A MECHANISM AS THOSE CENTERS DEVELOP WHERE OTHER CENTERS CAN THEN ALIGN WITH THEM, YOU COULD FUND THOSE, YOU KNOW, THROUGH SUPPLEMENTS TO THE ICs, YOU COULD FUND IT THROUGH SUPPLEMENTS TO THE CANCER CENTERS TO ACTUALLY BEGIN TO DEVELOP A BROADER COLLABORATIVE NETWORK. AND ANOTHER PIECE, MAYBE IT'S OUR CONVERSATION YESTERDAY AND THE EMAILS ELECTRA AND I HAVE EXCHANGED BUT ANOTHER COMPONENT OF THAT IMPLEMENTATION CENTER, I THINK, SHOULD BE TRAINING, CAPACITY BUILDING OF PEOPLE TO DO THIS WORK. SO IF THOSE LARGER CENTERS ALSO COULD HAVE THAT, AND THEN SMALLER CENTERS COULD BEGIN TO NETWORK AND COLLABORATE TO REALLY TRAIN PEOPLE OR HAVE THEM BE TRAINED BY YOU AND COME BACK HOME TO US, I JUST WOULD LOVE YOU TO THINK ABOUT THAT, BECAUSE I AGREE THAT PROBABLY THE FUNDING ISN'T ADEQUATE TO DO ALL THE THINGS WE ALL WOULD LOVE, BUT I LOVE THE CONCEPT OF TO BUILD AREAS OF FOCUS THAT COME FORWARD AND THEN THINKING ABOUT HOW THOSE OF US CAN BEGIN TO TIE IN WITH OUR POPULATIONS AND NETWORKS THAT WE COULD BRING TO THE PARTY WITH SUPPLEMENTAL FUNDING. BUT OVERALL, I THINK IT'S FANTASTIC. I REALLY LOVE TO SEE US GETTING PAST THEORY INTO TRUISM PLEM TAITION, SO IMPLEMENTATION SO CONGRATULATIONS. I IF YOUI FULLY SUPPORT IT. >> IT'S BEEN A CHALLENGE TO FIGURE OUT HOW DO WE BUILD OFF AREAS THAT HAVE AT LEAST A FAIR A START AND OTHER AREAS THAT WE SAY IF WE DON'T START THINKING ABOUT THIS, THEN WE'RE REALLY GOING TO MISS THAT OPPORTUNITY TO TAKE THOSE DISCOVERIES AND REALLY TRY TO APPLY THEM. IT WAS RECOGNIZING, WE WANTED TO CALL OUT THAT THERE ARE CERTAIN PLACES WHERE WE DON'T WANT TO WAIT AND WE THINK THERE ARE ESTABLISHED GROUPS THAT MAY NOT HAVE BEEN FOCUSING ON CANCER, MAYBE FOCUSING ON OTHER AREAS, THAT WE MIGHT BE ABLE TO BRING IN TO THINK ABOUT HOW DO WE FOCUS MORE ON DEIMPLEMENTATION, HOW DO WE THINK EARLY ABOUT PRECISION MEDICINE. IT'S THAT GOOD QUESTION TO SAY, IS THE SAME GROUP THAT IS ESTABLISHED AROUND A PARTICULAR SET OF EXPERTISE THE GROUP THAT WILL NATURALLY EXPAND TO SOME OF THOSE CURRENTLY UNDERSUBSCRIBED AREAS. SO THAT WAS REALLY THIS IDEA OF SAYING THAT THERE MIGHT BE TWO DIFFERENT STAGES. IT'S A GOOD POINT TO SAY THAT UNTIL WE KNOW WHETHER ANYONE IS GOING TO COME IN FOR THESE DEVELOPING CENTERS, WE DON'T QUITE KNOW HOW WELL IT WILL WORK, AND IT MAY BE THE CASE THAT IT'S THE ADVANCED CENTERS THAT END UP FLOWING. BUT IT WAS THAT IDEA OF HOW DO WE TRY AND PERMIT A SAFE SPACE FOR PEOPLE WHO MIGHT HAVE EXPERTISE FROM OTHER AREAS THAT WE WANT TO PULL IN TO THIS LARGER CONSORTIUM, AND THEN A GREAT POINT ABOUT TRAINING, AND THAT IS THIS IDEA OF TRYING TO SEE THESE CENTERS NOT AS SILOS, BUT THIS IDEA OF THE BROADER CONSORTIUM. SO WE'VE BEEN DOING A LOT OF THE TRAINING IN THE FIELD AND THE IDEA WAS TO TRY AND CREATE MORE OF THESE CENTERS OF EXCELLENCE, MORE OF THIS INSTITUTIONAL BASIS FOR THAT TRAINING BEING SPREAD. BUT IT'S ALWAYS HARD TO SAY, AS I THINK WAS MENTIONED, YES IT'S A BROAD SCOPE, YES, IT'S AMBITIOUS, YES, WE'RE TRYING TO LEVERAGE AROUND A LOT OF GOOD WORK BUT IT'S BEEN TOUGH TO TRY AND SAY WHAT IS THAT MAGIC AMOUNT PER CENTER -- >> THE COMMENTS ABOUT COULD YOU DEFINE SOME AREAS OF FOCUS THAT YOU THINK WOULD BE A GOOD START MIGHT GIVE MORE GRANULARITY TO WHAT THE LARGER CENTERS WANT TO DO. I THINK THIS COULD BE PHASE 1 AND YOUR PHASE 2 IS, HOW DO YOU THEN BEGIN TO DEVELOP COLLABORATIVE NETWORKS WITH THE LARGER CENTERS ACROSS CANCER CENTERS, ACROSS OTHER PROGRAMMATIC ASPECTS OF NCI, IT WOULD REALLY START REACHING DEEP INTO POPULATIONS. >> SURE. GREAT POINTS. THANK YOU. >> SO THIS WAS A REALLY INTERESTING CONCEPT, AND AN IMPORTANT ONE, BUT I HAVE TWO QUESTIONS ABOUT HOW YOU'RE THINKING ABOUT THIS IN THE LONG TERM. ONE IS, HAVE YOU BUILT IN TOOLS TO MEASURE SUCCESS? IT'S A GREAT CONCEPT, BUT HOW WILL YOU DETERMINE WHETHER YOU'RE GETTING WHERE YOU WANT TO BE? THE COROLLARY TO THAT IS, WHAT DO YOU IMAGINE IS THE DELIVERABLE IN THIS PROCESS? WILL THERE BE BEST PRACTICES THAT CAN BE IMPLEMENTED BY PEOPLE AS A WAY FORWARD TO IMPLEMENT GOOD IDEAS OR WILL THERE BE CONSULTING AWARD FOR NCI INVESTIGATORS? WHAT WILL THE FUTURE HOLD IN TERMS OF DELIVERABLES? >> IT'S A GREAT QUESTION. I THINK IF YOU REMEMBER THE SLIDE THAT TALKED ABOUT THE WORK THAT HAS BEEN DONE TO AGGREGATE EVIDENCE-BASED INTERVENTIONS, WHAT WE HAVEN'T DONE IS REALLY PULLED TOGETHER THAT KNOWLEDGE BASE AROUND THE IMPLEMENTATION STRATEGIES. ONE KEY DELIVERABLE WILL BE THE EQUIVALENT SO THAT SOMEBODY WHO IS TASKED WITH HOW DO I FIT THIS PARTICULAR INTERVENTION IN MY SETTING DOESN'T HAVE TO MAKE IT UP FROM SCRATCH, WHICH IS WHAT A LOT OF FOLKS HAVE BEEN DOING. HOW DO I CUSTOMIZE THIS, HOW DO I TAILOR IT. SO I THINK PART OF THE DELIVERABLE IS IN BEING ABLE TO SORT OF MAKE ACTIONABLE THE EMERGENT SET OF KNOWLEDGE AROUND WHAT ARE THOSE TOOLS THAT GET US INTERVENTIONS TO BE SUSTAINED WITHIN TIME. I THINK THERE ARE OTHER DELIVERABLES -- HAS WORKED FOR YEARS TO TRY TO GET THE LANDSCAPE OF WHAT CAN WE MEASURE AND WHAT IS MISSING. SO I THINK WE HAVE OTHER DELIVERABLES FILLING THE GAPS IN TERMS OF WHAT MEASUREMENT TOOLS CAN WE APPLY TO DIFFERENT STUDIE. I THINK IN TERMS OF DESIGNS, WE'RE SEEING THE EMERGENCE IN CLINICAL TRIALS OF A LOT OF DIFFERENT ADAPTIVE DESIGNS, OF THINKING MORE ABOUT CUSTOMIZED TREATMENT. THOSE ARE THE SAME KIND OF DESIGNS THAT WE'RE GOING TO NEED APPLIED TO IMPLEMENTATION WHEN WE KNOW THAT PROVIDERS VARY, SETTINGS VARY, ET CETERA. AND SO PART OF -- I THINK THERE ARE GOING TO BE SOME VERY SPECIFIC TOOLS THAT WE WILL SEE AFTER THE FIVE YEARS, THERE'S ALSO GOING TO BE OTHER THINGS, DO WE SEE THE MECHANISTIC FOCUS IN OUR R01s THAT ARE COMING IN ORGANICALLY TO OUR ONGOING P.A.s, DO WE SEE THAT ADVANCED, IS IT BEYOND THIS SORT OF ONE SIZE FITS ALL KIND OF THING. AND THEN THERE'S PUBLICATIONS AND THEN TRAINING, I THINK, IS ANOTHER ONE. WE'RE SEEING MORE PEOPLE WHO BEFORE WOULD SAY AT A PARTICULAR STAGE IN THEIR CAREER, NOW I WANT TO THINK ABOUT IMPLEMENTATION, THAT'S SHIFTING TO A NEW CROP OF INVESTIGATORS WHO ARE SAYING THIS FROM AN EARLY STAGE IN MY CAREER IS WHERE I REALLY WANT TO JUMP IN, SO I THINK SEEING THE WORKFORCE SHIFT OVER TIME IS ANOTHER INDICATOR. >> CAN YOU BUILD THOSE CONCEPTS INTO THE RFA, MEASUREMENT TOOLS FOR SUCCESS AND DELIVERABLES? >> YEAH, YEAH, YEAH. THANK YOU. >> HI, DAVID. CONGRATULATIONS AGAIN. I WANT TO ECHO WHAT EVERYBODY IS SAYING. THIS IS SOMETHING THE BLUE RIBBON PANEL IS VERY, VERY PROUD OF AND THANK YOU FOR CONTINUING TO PUSH THIS. I WANT TO REALLY ECHO WHAT KAREN SAID ABOUT POLICY. THOSE OF YOU WHO WERE ON THE WORKING GROUP IMPLEMENTATION SCIENCE WORKING GROUP, POLICY WAS PUT IN A SEPARATE LIST. REMEMBER, WE HAD TO FOCUS ON THE RESEARCH. BUT THE MORE AND MORE I TALK, ESPECIALLY TO MY CLINICIAN COLLEAGUES WHO WORK IN COMMUNITY HEALTH CENTERS, THE V.A., AND THE CANCER CENTERS, THEY TELL ME TIME AND TIME AGAIN, WITHOUT THE POLICY, YOU CAN HAVE ALL THESE MODELS, YOU CAN HAVE ALL THESE EBIs AND WHAT YOU HAVE, AND UNTIL WE'RE ABLE TO INFLUENCE POLICY, WE'RE NOT GOING TO BE ABLE TO MAKE HUGE DENTS HERE. SO IS IT POSSIBLE TO HAVE A LONG TERM DELIVERABLE, THE POLICY THAT CAN -- YOU KNOW, YOU HAVE ALL THIS EVIDENCE, HOW DO WE MOVE IT INTO POLICY. SO IN COMMUNITY HEALTH CENTERS, IF THERE IS A WAY THAT YOU CAN DRIVE THE POLICY SO THAT THIS IS ADOPTED AND PAY PAID FOR AND WHAT PAID FOR AND WHAT HAVE YOU, THAT'S WHEN YOU TRULY HAVE CHANGE. THAT'S A TALL ORDER AND WE STRUGGLE WITH THAT. >> SO I THINK IT'S A REALLY IMPORTANT LEVERAGE POINT THAT EITHER IS GOING TO INCREASE UPTAKE OR IN SOME CASES GET IN THE WAY. I'D LIKE TO THINK THAT OUT OF THESE LABORATORIES REALLY, NATURAL LABORATORIES FOR IMPLEMENTATION, WE'LL HAVE THE OPPORTUNITY TO REALLY LEARN FROM A WHOLE RANGE OF DIFFERENT POLICY -- WHETHER YOU CALL THEM SOLUTIONS OR MAYBE NOT SOLVING IT AS WELL AS WE WOULD LIKE. AS I SEE IT, THESE CENTERS ARE RESEARCH CENTERS SO THEY ARE TRYING TO ADVANCE THE KNOWLEDGE BASE. BUT I THINK THAT KNOWLEDGE BASE CAN BE EXTENDED BY UNDERSTANDING HOW DO VARIOUS FEATURES OF THE LOCAL ENVIRONMENT IMPACT ON SUCCESSFUL IMPLEMENTATION, IMPACT ON SUCCESSFUL DEIMPLEMENTATION WHEN WE NEED TO STOP THINGS, IMPACT ON DISPARITIES WHERE WE'RE TRYING TO ADVANCE THEM. SO I BOPT SEE THAT BOTH SEE THERE'S A CHAN CE TO LEARN FROM IT, I ALSO SEE THAT THERE'S AN OPPORTUNITY TO DEVELOP A KNOWLEDGE BASE THAT'S GOING TO HELP WITH A WHOLE RANGE OF DIFFERENT DECISIONS THAT NEED TO BE MADE AT DIFFERENT LEVELS. BOB MIGHT WANT TO -- >> ONE OF THE BIGGEST GAPS THAT MANY OF YOU ARE FAMILIAR THAT WE'VE ENCOUNTERED IS THAT OUR RESEARCH COMMUNITY IS VERY UNFAMILIAR WITH THE CRITERIA BY WHICH POLICY AND PAYMENT DECISIONS GET MADE. AND SO I THINK PART OF THIS EDUCATIONAL EFFORT IS, OUR APPLIED RESEARCH CONSISTENCY NEEDS TO BE BETTER TRAINED AND INFORMED ABOUT WHAT'S THE RELEVANT GERMANE EVIDENCE THAT NEEDS TO BE GENERATED FROM THEIR INTERVENTION STUDIES. IF YOU'RE TESTING AN INTERVENTION TO IMPROVE UP TAKE TO CLOA LOW COLORECTAL CANCER -- IF YOU DOWNED UNDERSTAND REGULATIONS YOU'RE DEAD IN THE WATER. SO WE HAVE KIND OF A KNOWLEDGE GAP BUT THEN AS DAVID MENTIONED A METHODS AND MEASURES GAP. WE NEED MORE ME TOURS OF COST BUILT IN TO INTERVENTION STUDY, NOT JUST BEHAVIOR CHANGE, BUT HOW MUCH DOES IT COST TO ACHIEVE, EQUIP OR QUIT FOR A TOBACCO SMOKE E AND THEN WORK WITH FELLOW AGENCIES TO MARRY OUR PROCESS WITH A POLICY DEVELOPMENT EVIDENCE REVIEW AND DECISION-MAKING IN THE POLICY CONTEXT JUST AS WE DO FOR THERAPEUTICS, DIAGNOSTICS AND OTHER DOMAINS. >> THANK YOU. >> THIS IS A VERY IMPORTANT INITIATIVE BUT I WANT TO GO BACK TO THE QUESTION OF HOW DO WE MEASURE SUCCESS. WITH UP TAKE OF BEST PRACTICES AT POPULATION LEVEL INCIDENCE AND MORTALITY. THINKING SPECIFICALLY IN THE AREA OF SCREENING AND THE FACT THAT WE DON'T ACTUALLY INCLUDE THE SCREEN DETECTION MODE IN THE SEER DATABASE MAKES IT HARD TO UNDERSTAND HOW MUCH IMPACT SCREENING HAS HAD HE POPULATION LEVEL. AND THAT EXTENDS BEYOND SCREENING. SO I WOULD JUST SUGGEST THAT US A MOVE THIS FORWARD, YOU WORK WITH THE CANCER REGISTRIES AND THINK MORE ABOUT HOW TO INTRODUCE INFORMATION INTO THE REGISTRIES AS TO HOW THESE PRACTICE PATTERNS ARE CHANGING UPTAKE OF PREVENTION AND SCREENING AND OTHER INTERVENTION STRATEGIES. >> I THINK THAT'S A GREAT POINT. ONE OF THE THINGS THAT OUR GROUP DOES EVERY MONTH IS A SET OF WEBINARS WHERE WE'RE THINKING ABOUT AREAS THAT WE REALLY NEED TO GROW. NEXT MONTH THAT IS A CONVERSATION ABOUT HOW DO WE INTEGRATE IMPLEMENTATION SCIENCE AND SURVEILLANCE, SO LYN PENBERTHY AND I ARE GOING TO BE UK TING ABOUT THESE KIND OF ISSUES OF HOW CAN WE -- AS SEER, I THINK, ALREADY HAS BEEN MOVING TO BE THINKING ABOUT DIFFERENT DATA LINKAGES, HOW DO WE ADVANCE THAT SO WE HAVE A MUCH BETTER SENSE OF WHAT DOES IMPLEMENTATION LOOK LIKE ON THE GROUND LEVEL, WHICH AT LEAST HISTORICALLY WE'VE HAD A LOT OF GAPS FOR. WITHBUT I THINK THAT'S A GREAT POINT. THE OTHER THING, I THINK WHAT'S BEEN NICE ABOUT JUST THE OVERALL MOONSHOT EFFORT IS THAT WHILE I MENTIONED THE THREE GROUPS, AND YOU'LL HEAR FROM THE PATIENT ENGAGEMENT GROUP WHICH IS ALSO TIED IN, IT'S BEEN GRADE GRATE TO WORK WITH THE FOLKS WHO ARE THINKING ABOUT TECHNOLOGIES, WHO ARE THINKING ABOUT THE CANCER DATA ECOSYSTEM, BECAUSE IDEALLY, THIS ALL COMES TOGETHER AND THA'S, I THINK, OUR HOPE. >> TERRIFIC. THANKS MUCH. WE'RE GOING TO MOVE TO A MOTION NOW I'LL TAKE THE CHAIR'S PREROGATIVE TO MAKE A QUICK COMMENT FOLLOWING UP ON BOB'S WHICH IS THAT THERE ARE OPPORTUNITIES TO WORK WITH VALUE BASED CARE INITIATIVES BS FOR EXAMPLE, WITH THE OCM THROUGH CMMI, AND TO FORGE RELATIONSHIPS WITH THOSE IN THE QUALITY, IN THE Q.I. SPACE WHICH ALL OF OUR INSTITUTIONS HAVE, WHICH ARE ACTUALLY IMPLEMENTING STUFF ALL THE TIME. DR. EVANS, I'LL MOVE TO YOU FOR A MOTION. >> I'D MAKE A MOTION TO APPROVE THE CONCEPT. >> SECOND. >> I'LL SEC. >> SECOND. >> OKAY. DISCUSSION? OKAY. ALL IN FAVOR TO APPROVE? DISAPPROVE? DEFER? IT'S UNANIMOUS. THANK YOU VERY MUCH. THAT WAS A VERY NICE DISCUSSION. WE'RE GOING TO MOVE NOW TO THE NEXT CONCEPT, COMMUNICATIONS AND DECISION-MAKING IN THE CONTEXT OF RISK AND UNCERTAINTY FOR INDIVIDUALS WITH INHERITED CANCER SYNDROMES. THIS IS AN RFA. DR. WENDY NELSON IS GOING TO PRESENT. THANK YOU, WENDY. I THINK YOUR MICROPHONE IS NOT LIVE. >> THAT'S BETTER. GOOD MORNING. I'M GOING TO BE PRESENTING OUR CONCEPT ON COMMUNICATION DECISION-MAKING FOR INDIVIDUALS WITH INHERITED CANCER SYNDROMES. THE BASIS FOR OUR RFA IS A BLUE RIBBON PANEL RECOMMENDATION G, WHICH CALLS FOR IMPROVING THE CURRENT STAIFT EARLY DETECTION, GENETIC TESTING, GENETIC COUNSEL, AND I CREASING TESTING FOR HEREDITARY CANCER SYNDROMES SO PEOPLE CAN BEGIN EARLY PREVENTION AND SCREENING EFFORTS. IN A FEBRUARY 27 WORKSHOP, THE CASE OF LINT SYNDROME DISDISCUSS APPROACHES TO RECOMMENDATION G. THE MEDIUM COVERAGE TESTING, CURRENT PRACTICES, DELIVERY APPROACHES -- FOR HEREDITARY CANCERS, AND ONE OF THE MAJOR THEMES OF THIS MEETING WAS THE NEED FOR STUDIES ON COMMUNICATION AND DECISION-MAKING. SO THE GOAL OF OUR RFA IS TO DEVELOP, TEST AND EVALUATE INTERVENTIONS AND IMPLEMENTATION APPROACHES OR -- TO PROVIDE PATIENT, PROVIDER, DECISION-MAKING FOR INDIVIDUALS AND FAMILIES WITH INHERITED SUSCEPTIBILITY TO CANCER. I'D LIKE TO POINT OUT THAT YOU MAY RECALL THAT YOU PREVIOUSLY APPROVED A MOONSHOT RFA THAT CALLED FOR EVIDENCE-BASED HEALTHCARE DELIVERY MODELS FOR HEREDITARY CANCER PREVENTION AND DETECTION. AND THIS PROPOSED RFA, OUR PROPOSED RFA, WAS DEVELOPED TO COMPLEMENT THIS EARLIER MOONSHOT RFA ON HEREDITARY CANCER SYNDROMES. NOW, IT'S BELIEVED THAT HEREDITARY CANCERS ACCOUNT FOR 5 TO 10% OF ALL CANCERS. THIS DIAGRAM ILLUSTRATES WHY COMMUNICATION IS SO CRITICAL IN THE DELIVERY OF QUALITY CARE FOR INDIVIDUALS WHO HAVE AN INHERITED SUSCEPTIBILITY TO CANCER. THERE ARE A NUMBER OF KEY POINTS OF COMMUNICATION HERE. SO HERE YOU HAVE A PATIENT WITH CANCER DIAGNOSIS OR PERHAPS A FAMILY HISTORY OF CANCER, AND THEY'RE GOING TO NEED TO COMMUNICATE WITH EITHER A MEDICAL ONCOLOGIST, RADIATION ONCOLOGIST, A SURGEON, AN INTERNIST, PRIMARY CARE DOCTOR, WHO WILL THEN PROVIDE A REFERRAL FOR GENETIC COUNSELING. THE GENETIC COUNSELOR MUST THEN CONTACT THE INDIVIDUAL AND THEN EDUCATE THE PATIENT ABOUT TESTING PROCEDURE, OBTAIN CONSENT TO TEST, AND THEN DELIVER THE RESULTS IN A WAY THAT'S GOING TO FACILITATE DECISION-MAKING FOR THEIR CLINICAL CARE. BUT SOMETIMES YOU GET AN UNINFORMED TEST RESULT SUCH AS A VARIANT OF UNCERTAIN SIGNIFICANCE, AND CURRENTLY THERE ARE NO BEST PRACTICES FOR HOW TO COMMUNICATE ABOUT AN UNINFORMED TEST RESULT. AND THEN FINALLY, THEY MUST COMMUNICATE WITH THE FAMILY AND FAMILY MEMBERS IN A WAY THAT'S GOING TO MINIMIZE PSYCHOLOGICAL DISTRESS, BUT ALSO HELP THEM MAKE A GOOD CLINICAL MANAGEMENT DECISION. AND THEN FINALLY, INFORMATION NEEDS TO BE COMMUNICATED BACK TO THE PRIMARY CARE PROVIDER SO THAT PATIENTS AND THEIR FAMILY MEMBERS CAN RECEIVE APPROPRIATE FOLLOW-UP CARE. IS NOW WE KNOW THAT PATIENTS BENEFIT FROM PARTICIPATING IN THE DECISION-MAKING PROCESS, BUT COLLABORATIVE PATIENT PROVIDER DECISION-MAKING CAN ONLY OCCUR IF THERE'S EFFECTIVE COMMUNICATION. AND COMMUNICATION IS ESSENTIAL TO UNDERSTANDING RISK AND MANAGING UNCERTAINTY, AND INDIVIDUALS NEED TO UNDERSTAND THEIR RISK IF THEY'RE GOING TO MAKE GOOD CLINICAL RISK MANAGEMENT DECISIONS FOR THEMSELVES. BUT HOW WE UNDERSTAND RISK IS INFLUENCED BY A LOT OF DIFFERENT FACTORS, SUCH AS COGNITIVE BIASES, CULTURAL BELIEFS, PERSONAL ILLNESS EXPERIENCES, OR FAMILY HISTORY OF CANCER. UNFORTUNATELY, THERE ARE NO GOLD STANDARD PRACTICES FOR COMMUNICATING RISK AND COMMUNICATING JE NE IT TICK TEST RESULTS. GENETIC TEST RESULTS AND WE NEED COMMUNICATION STRIKE THAT YEES TO PROMOTE GUIDELINE CON KORNS, TESTING AND FOLLOW-UP HEALTHCARE. FOR EXAMPLE, WITH HE KNOW 60 TO 80% OF PEOPLE WHO ARE REFERRED FOR GENETIC SERVICES DO NOT MEET THE FAMILY HISTORY OR REFERRAL REQUIREMENT. WE NEED TO FACILITATE DISCLOSURE OF GENETIC TESTS TO FAMILY MEMBERS AND WE ALSO NEED TO IMPROVE THE COUNSELING PROCESS FOR THE RETURN OF UNINFORMATIVE TEST RESULTS SUCH AS VARIANT OF UNCERTAIN SIGNIFICANCE, AND THIS IS PARTICULARLY IMPORTANT SINCE NEXT GENERATION SEQUENCING TECHNOLOGY MEANS WE'RE GOING TO BE IDENTIFYING MORE AND MORE VARIANTS OF UNCERTAIN SIGNIFICANCE. SO THE AIMS OF OUR RFA ARE TO SOLICIT APPLICATIONS THAT WILL DEVELOP, TEST, EVALUATE AND IMPLEMENT INTERVENTIONS OR ADAPT AND IMPLEMENT EXISTING INTERVENTIONS THAT LOOK AT PATIENT LEVEL COMMUNICATION APPROACHES TO GENETIC COUNSELING AND TESTING THAT PROMOTE UNDERSTANDING OF GENETIC RISK AND HELP GUIDE CLINICAL MANAGEMENT DECISION-MAKING. AND THESE CAN BE TECHNOLOGICAL APPROACHES SUCH AS TELEGENETICS, CAN BE ORAL APPROACHES OR THEY COULD BE WRITTEN APPROACHES. AND WE NEED A VARIETY OF COMMUNICATION APPROACHES DEPENDING ON THE CLINICAL SETTING THAT WE'RE WORKING IN AND THE PATIENT POPULATION WE'RE ADDRESSING. FOR EXAMPLE, WE MIGHT BE WORKING IN A COMMUNITY HOSPITAL SETTING OR AN HMO SETTING OR A PRIVATE PRACTICE SETTING. WE MIGHT BE ADDRESSING A MINORITY POP LAYING, NON-ENGLISH SPEEP SPEEKING POPULATION, AND WE NEED TO INCLUDE MULTIPLE HEALTHCARE SETTINGS BECAUSE SO MUCH OF CLINICAL CARE IS NOW DELIVERED OUTSIDE OF ACADEMIC HEALTH SETTINGS. WE NEED COMMUNICATION APPROACHES ALSO FOR CANCER RISK DISCLOSURE TO FAMILY MEMBERS, WE NEED TAILORED COMMUNICATION STRATEGIES THAT WILL ADDRESS THE UNIQUE NEEDS OF UNDERSERVED POPULATIONS SUCH AS LOW INCOME POPULATIONS, MINORITY, RURAL, LOW PNEUMONIA NUMERA TE., NON-ENGLISH SPEAKING POPULATIONS, AND FINALLY WE NEED TOOLS AND TECHNIQUES THAT WILL PROMOTE UNDERSTANDING OF RISKS AND IMPROVE CLINICAL MANAGEMENT DECISION-MAKING. ARE WE ARE ENCOURAGING PEOPLE TO STUDY ALL INHERITED CANCER SYNDROMES, NOT SIMPLY HEREDITARY, BREAST AND OVARIAN CANCER SYNDROME OR LINK SYNDROME, AND WE ALSO NEED STUDIES OF ALL AT RISK INDIVIDUALS. WE WOULD LIKE STUDIES THAT GO ACROSS A VARIETY OF GENETIC COUNSELING METHODS AND PROVIDERS, AND STUDIES THAT WILL ADDRESS DEMOGRAPHICALLY DIVERSE POPULATIONS, AND WE ARE STRONGLY RECOMMENDING THAT APPLICANTS CONDUCT CLINICAL TRIALS. THIS IS A HYPOTHETICAL EXAMPLE OF WHAT INTERVENTION MIGHT LOOK LIKE. FOR EXAMPLE, YOU COULD BE WORKING IN A FEDERALLY QUALIFIED HEALTH CENTER WHERE YOU'RE DEALING WITH AN UNDERSERVED URBAN POPULATION, OR YOU MIGHT BE WORKING IN AN URBAN INTEGRATED MANAGED CARE PRACTICE LIKE AN HMO, WHICH IS AN URBAN, MORE MIDDLE CLASS POPULATION, AND THEN YOU CAN LOOK AT DIFFERENT MODES OF DELIVERING GENETIC COUNSELING. IN THIS CASE, I'VE JUST PUT TELEGENETICS AND GROUP COUNSELING AND IN-PERSON COUNSELING. AND YOU CAN SEE, ARE OTHER METHODS, ALTERNATIVE METHODS OF COUNSELING AS EFFECTIVE AS IN-PERSON COUNSELING. AND THEN I JUST LISTED SOME PSYCHOSOCIAL COMMUNICATION AND BEHAVIORAL OUTCOMES THAT YOU COULD THEN LOOK AT AND COMPARE, PERHAPS IN-PERSON COUNSELING, PATIENTS FEEL MORE SATISFIED WITH COUNSELING, WHEREAS WITH GROUP COUNSELING, THEY MAY FEEL LESS ANXIOUS AND LESS WORRIED BECAUSE OF THE GROUP DYNAMIC. SO EACH OF THESE OUTCOMES IS AN OUTCOME IN AND OF ITSELF, AND IT AT THE SAME TIME, IT'S ALSO A FACTOR IN DETERMINING WHETHER THE INDIVIDUAL WILL PURSUE GENETIC TESTING AND GET THE APPROPRIATE FOLLOW-UP CARE. FOR EXAMPLE, IF SOMEONE IS NOT SATISFIED WITH COUNSELING OR THEY'RE OVERLY ANXIOUS AND STRESS BIDED BY COUNSELING, THEY MAY NOT PURSUE TESTING AND GET THE HEALTHCARE THEY REALLY NEED. SOMETHING I'D ALSO LIKE TO POINT OUT, THIS IS FROM A DISCUSSION I HAD WITH A PROGRAM DIRECTOR COLLEAGUE IN THE LC PROGRAM AT NHGRI, AND HE HAD VERY GRACIOUSLY REVIEWED THE CONCEPT AND WAS GIVING ME FEEDBACK, AND THE VERY FIRST THING HE SAID TO ME WAS, YOU HAVE ABSOLUTELY NO IDEA THE EXTENT OF MISUNDERSTANDING THAT THERE IS SURROUNDING GENETIC TESTING. HE SAID WHAT WE REALLY NEED IS TO IDENTIFY THE BARRIERS TO UNDERSTANDING AND DEVELOP BETTER WAYS OF CLARIFYING AND COMMUNICATING THIS INFORMATION TO THEM. WE WOULD LIKE STUDIES TO FACILITATE UNDERSTANDING OF GENETIC RISK AND DELIVERY OF COUNSELING AND IMPROVE CLINICAL MAN AJT MANAGEMENT DECISIONS. HEWE WOULD LIKE TO SEE GEOGRAPHICALLY DIVERSE POPULATIONS INCLUDED, WE WOULD LIKE COMMUNICATION RELATED TO GENETIC COUNSELING AND TESTING AND RISK MAN AJT DECISION-MAKING, WE WOULD LIKE FOCUS ON A VARIETY OF CLINICAL SETTINGS AND COUNSELING METHODS, DEMONSTRATE INTERDISCIPLINARY COLLABORATIONS, AND ALSO DEMONSTRATE EVIDENCE OF RESEARCH PRODUCTIVITY AND IMPACT OF JOURNALS. WE WILL CONDUCT FUNDED EXTRAMURAL RESEARCH PROJECTS SPECIFICALLY FOCUSED ON APPROACHES TO OPTIMIZE COMMUNICATION AND DECISION-MAKING IN THE CONTEXT OF INHERITED CANCER SYNDROMES, AND WE IDENTIFIED 10 GRANTS THAT WERE RELATED TO COUNSELING, COMMUNICATION OF GENETIC INFORMATION OR DECISION-MAKING. BUT UNFORTUNATELY NO GRANTS BROADLY FOCUSED ON HEREDITARY SYNDROMES, AND WE NEED TO SOLICIT APPLICATIONS WITH A BROADER FOCUS BECAUSE WHEN PEOPLE PRESENT, THEY OFTEN PRESENT WITH A FAMILY HISTORY THAT DOESN'T FIT NEED NEETLY INTO NEATLY INTO A PARTICULAR SYNDROME. NINE OF THESE 10 GRANTS FOCUSED EXCLUSIVELY ON HEREDITARY BREAST AND OVARIAN CANCER, ONLY TWO ADDRESSED MULTI-GENE PANEL TESTING, AND THIS IS AN UNDERSTUDIED AREA. WE NEED TO UNDERSTAND HOW PEOPLE ARE MAKING DECISIONS ABOUT WHETHER OR NOT TO HAVE PANEL TESTING, AND IF THEY HAVE PANEL TESTING, HOW THEY'RE USING THE RESULTS OF PANEL TESTING TO MAKE RISK MAN MANAGEMENT DECISIONS. TWO OF THE GRANTS ADDRESSED COMMUNICATION WITH LATINO POPULATIONS AND ONLY ONE ADDRESSED COMMUNICATION OF VARIANT OF UNCERTAINTY SIGNIFICANCE RESULTS. AS I MENTIONED EARLIER, THIS IS PARTICULARLY IMPORTANT NOT ONLY BECAUSE OF VARIANT OF UNCERTAIN SIGNIFICANCE RESULT MAKES IT DIFFICULT TO PROVIDE ANY KIND OF CLINICAL RECOMMENDATION, BUT ALSO BECAUSE WE'RE PROBABLY GOING TO BE IDENTIFYING MORE AND MORE VARIANTS OF UNCERTAIN SIGNIFICANCE IN THE FUTURE. WE ARE REQUESTING A COOPERATIVE AGREEMENT SO THAT WE CAN ASSURE THAT THE PROJECTS THAT WE AWARD ADDRESS THE SCIENCE THAT WE WOULD LIKE TO SUPPORT. WE WOULD LIKE TO SEE FIVE AWARDS FOR FISCAL YEARS 2019 THROUGH 2023 AT AN ANNUAL COST OF $5 MILLION A YEAR FOR A TOTAL COST OF 25 MILL YONDZ. $25 MILLION. IN SUMMARY, OUR RFA ADDRESSES RECOMMENDATION G OF THE BLUE RIBBON PANEL REPORT, AND IT COMPLEMENTS RFA CA-17-041 BY ADDRESSING COMMUNICATION AND DECISION-MAKING THAT NEED TO BE PART OF DELIVERY PROCESS FOR INDIVIDUALS WITH INHERITED CANCER SYNDROMES. THE GOAL OF 17-041 WAS TO INCREASE CASE ASCERTAINMENT OF HEREDITARY CANCERS AND DEVELOP EVIDENCE-BASED HEALTHCARE DELIVERY MODELS FOR HEREDITARY CANCER DETECTION AND PREVENTION. THE RFA SEEKS TO ESTABLISH BEST PRACTICES FOR HOW WE CAN COMMUNICATE GENETIC RISK IN THE CONTEXT OF UNCERTAINTY AND ENCOURAGES PROJECTS THAT WILL DEVELOP, TEST, EVALUATE AND IMPLEMENT EFFECTIVE RISK COMMUNICATION STRATEGIES FOR DIVERSE POPULATIONS AND CLINICAL SETTINGS, AND ENCOURAGES PROJECTS THAT WILL DEVELOP OR IMPROVE APPROACHES TO COMMUNICATING HEALTH INFORMATION VIA TECHNOLOGY. AND THIS IS PARTICULARLY IMPORTANT SINCE THE DEMAND FOR GENETIC SERVICES NOW FAR EXCEEDS THE NUMBER OF GENETIC COUNSELORS IN THIS COUNTRY. AND THERE ARE WHOLE AREAS, I'VE LOOKED AT A MAP WHERE GENETIC COUNSELORS ARE, THERE ARE WHOLE AREAS WHERE THERE MAY BE 1 OR 2 IN THE STATE, GENETIC COUNSELORS IN THE STATE. AND SO FINALLY, WE WOULD LIKE TO THANK OUR SUBCOMMITTEE FOR THEIR VERY HELPFUL QUESTIONS AND HELPFUL CONFERENCE CALL, AND AS A RESULT OF OUR DISCUSSION, WE MADE SOME CLARIFICATIONS AND CHANGES TO OUR CONTENT AND I'D JUST LIKE TO BRIEFLY REVIEW FOUR OF THE QUESTIONS THE COMMITTEE POSED TO US. THEY ASKED HOW WE WILL MEASURE THE SUCCESS OF THE PROPOSED AND THERE ARE A COUPLE WAYS WE CAN DO THAT. WE CAN LOOK AT THE PSYCHOSOCIAL BEHAVIORAL AND COMMUNICATION OUTCOMES ON THE SLIDE THAT I JUST SHOWED YOU, AND WE CAN ALSO LOOK FOR EVIDENCE OF ADHERENCE TO GUIDELINE-CONCORDANT GENETIC TESTING AND FOLLOW-UP, EVIDENCE OF OUTREACH TO DIVERSE POPULATIONS, EVIDENCE OF OUTREACH TO AT-RISK RELATIVES AND EVIDENCE OF CASCADE TESTING FOR RELATIVES. AND THEN THEY ASKED HOW CAN YOU TAILOR COMMUNICATION STRATEGIES FOR UNDERSERVED POPULATIONS IF GENETIC COUNSELING IS NOT OFFERED, AND THAT'S WHY WE REALLY NEED TECHNOLOGY, SO WE CAN REACH THESE UNDERSERVED GROUPS SUCH AS RURAL, MINORITY, NON-ENGLISH-SPEAKING POPULATIONS. AND THEN THEY ASKED, HOW DOES RISK COMMUNICATION IN THE CONTEXT OF INHERITED CANCER DIFFER FROM OTHER SITUATIONS? AND WE REALLY THOUGHT ABOUT THAT ONE FOR A LONG TIME. AND WE FELT THAT ANY TIME YOU'RE TALKING ABOUT COUNSELING, TESTING, CHOOSING RISK MANAGEMENT STRATEGY, I MEAN, COMMUNICATION IS GOING TO BE VERY COMPLEX, AND FRAUGHT WITH A LOT OF UNCERTAINTY. AND FURTHERMORE, TESTING DOESN'T ONLY HAVE SIGNIFICANT IMPLICATIONS FOR THE INTERVENTION, BUT IT MAY HAVE VERY SIGNIFICANT IMPLICATIONS FOR FAMILY MEMBERS AND FUTURE OFFSPRING, IT MAY HAVE IMPLICATIONS FOR DECISIONS ABOUT MARRIAGE, DECISIONS ABOUT CHILD BEARING. AND FINALLY, AN UNINFORMED TEST RESULT CAN ENGENDER EXTREME EMOTIONAL RESPONSES RANGING FROM UNDUE ANXIETY AND WORRY ALL THE WAY TO BEING FALSELY REASSURED THAT YOU HAVE NOTHING TO WORRY ABOUT. AND FINALLY, WE HAD INITIALLY SAID THAT OUR PROJECT SHOULD FOCUS ON AT LEAST TWO CLINICAL SETTINGS AND AS THE COMMITTEE POINTED OUT, IF SOMEONE HAS EXPERTISE WORKING WITH THE PARTICULAR POPULATION LIKE A RURAL POPULATION OR NON-ENGLISH-SPEAKING POPULATION, IT MAKES SENSE FOR THEM TO FOCUS IN THAT CLINICAL SETTING. SO WE ARE NOT REQUIRING TWO CLINICAL SETTINGS, BUT AGAIN, WE ARE JUST ENCOURAGING THAT. AND WITH THAT, THANK YOU TO THE SUBCOMMITTEE, AND THANK YOU FOR YOUR ATTENTION. [APPLAUSE] >> THANK YOU VERY MUCH. WE'LL NOW TURN TO THE SUBCOMMITTEE CHAIRED BY DIANE QUAIL, MARY LOU SMITH WHO IS NOT HERE TODAY WAS ALSO ON THE COMMITTEE AND PARTICIPATED IN THE CALLS AND I WAS ALSO ON THIS COMMITTEE. I'LL TURN TO DIANE. >> THANKS, WENDY, THAT WAS A GREAT PRESENTATION. THANK YOU FOR YOUR RESPONSIVENESS. YOU GOT BACK TO US QUICKLY WITH OUR QUESTIONS AND AS YOU MENTIONED, WE HAD A GREAT CALL. THE SUBCOMMITTEE IS VERY SUPPORTIVE OF THIS CONCEPT BECAUSE WE BELIEVE IT ADDRESSES A REALLY IMPORTANT NEED IN THE CANCER COMMUNITY, EFFECTIVELY COMMUNICATING INFORMATION REGARDING GENETIC RISK FOR CANCER, AND PROVIDING PATIENTS AND THEIR FAMILIES WITH THE TOOLS TO MAKE THEM ACTIVE PARTICIPANTS IN THEIR CARE WILL IMPROVE OUTCOMES AND WE THINK THIS CONCEPT IS A VERY GOOD ONE. YOU COVERED OUR QUESTIONS REALLY WELL IN YOUR PRESENTATION. OUR PRIMARY QUESTION HAD TO DO WITH MEASURING OUTCOMES, RECOGNIZING THAT ONE SIZE DOES NOT FIT ALL, AND HOW ARE WE GOING TO MAKE SURE THAT THESE INTERVENTIONS ARE SUCCESSFUL AND THE STAFF GAVE US A GOOD IDEA OF THE EXAMPLES AND THINGS THEY WILL INCLUDE TO HELP MEASUREMENT ONE QUESTION THAT WE DID RAISE THAT WASN'T COVERED WAS WE HAD A QUESTION AS TO WHETHER OR NOT THIS PROPOSAL WAS DIRECTED AT THE PUBLIC OR JUST PATIENTS WHO ALREADY WERE DIAGNOSED WITH CANCER, RECOGNIZING THAT YOU HAVE TO REACH -- THOSE ARE TWO DIFFERENT GROUPS THAT YOU NEED TO REACH. AND THE STAFF EXPLAINED THIS WAS MEANT TO REACH THE GENERAL PUBLIC SO WE ENCOURAGE THEM TO MAKE SURE THAT THESE INTERVENTIONS RECOGNIZE THE DIFFERENCE IN THOSE TWO GROUPS BECAUSE YOU WILL NEED DIFFERENT TOOLS TO DO SO. AND OTHER WIE, I THINK EVERYTHING ELSE WAS COVERED WELL, SO THANK YOU VERY MUCH. >> THANKS. I ALSO SERVED ON THE EXPHIT EE. I DON'T HAVE MUCH TO ADD. I WOULD SAY ONE OF THE AREAS THAT WE WERE INTERESTED IN THAT YOU DID COVER WAS THE DEVELOPMENT OF BEST PRACTICES OUT OF THIS CONSORTIUM, YOU'RE LOOKING AT A VARIETY OF APPROACH, WE THOUGHT THAT WOULD BE A CONTRIBUTION TO THE FIELD THAT COULD COME OUT OF THIS AS A DISCRETE DELIVERABLE. THE SECOND WAS THAT WE HAD QUESTIONS ABOUT WHETHER THE TECHNIQUES DEVELOPED WOULD ONLY APPLY TO GENETIC COUNSELORS OR WERE THESE TECHNIQUES THAT COULD BE USED BY, SAY, PHYSICIANS, BY NURSE NAVIGATORS, BY LAY PROFESSIONALS, AND ARE THOSE WITHIN THE CONSTELLATION. I THINK THAT YOU ALLUDED TO THAT, THAT YOU'RE REALLY LOOKING BROADLY BUT YOU COULD COMMENT ON THAT. >> YES, WE ARE LOOKING BROADLY, BECAUSE OF THE SCARCITY OF GENETIC COUNSELORS, I THINK WE NEED TO LOOK FOR OTHER WAYS AND OTHER PROVIDERS THAT CAN PROVIDE THOSE SERVICES OR AT LEAST AN APPROXIMATION OF GENETIC COUNSELING. >> THANK YOU. I THINK WE CONCUR WITH YOUR PERSPECTIVE ON THAT. THINK THE THIRD WAS A GENERAL COMMENT WHICH IS THAT BECAUSE THIS IS AN AREA WHERE TELEHEALTH, TELEMEDICINE WILL LIKELY PLAY A ROLE, WE THOUGHT THIS MIGHT BE AN AREA RIPE FOR SBIRs IN THE FUTURE AS THIS COULD BE OF INTEREST TO THE PRIVATE SECTOR AS WELL FOR CREATING TOOLS. OKAY. WITH THAT, I WOULD TURN TO THE GROUP FOR ANY DISCUSSION. >> A VERY NICE PRESENTATION AND THANK YOU FOR EVERYONE'S EFFORTS FOR FOCUSING ON THIS. I GUESS THE QUESTION WITH REGARDS TO HOW ARE YOU GOING TO DEAL WITH THE DIRECT-TO-CONSUMER GENETIC TESTING THAT'S ALREADY OUT THERE? I WON'T REVISIT ALL THE PROBLEMS THAT EXIST, BUT THESE FOLKS ARE NOT HAVING COUNSELING AND THEY'RE GOING TO THEIR PRIMARY CARE PRACTITIONERS, AND I THINK ONE OF THE THINGS THAT'S LEFT OUT HERE IS, YOU KNOW, THE CONNECTION DIRECTLY WITH THE COUNSELOR AND THE PCP OR THINGS LIKE THAT TO REALLY HELP WITH THE CASCADE TESTING AND HELP WITH THE FOLLOW-THROUGH. SO I THINK AS THE TRAIN HAS LEFT THE STATION AND EF ONE IS EVERYONE IS SIGNING UP TO HAVE DIRECT-TO-CONSUMER SNP ANALYSIS, HOW CAN THAT BE IMPLEMENTED BECAUSE WE DON'T HAVE ENOUGH GENETIC COUNSELORS, AND THIS IS SUCH AN IMPORTANT AVENUE TO REDUCE OUR CANCER BURDEN, AND NOT HAVE TO WAIT UNTIL SOMEONE IN THE FAMILY GETS CANCER, THAT I GUESS I WOULD -- CONSIDERING THAT US A LOOK TO THE IMPLEMENTATION OF THIS, IT FALLS WELL INTO THE LAST IMPLEMENTATION SCIENCE APPROACH AS WELL. >> I THINK IN MY CONCEPT, I HAD PUT A POSSIBLE RESEARCH QUESTION RELATING TO DIRECT-TO-CONSUMER, BECAUSE WE REALLY DON'T KNOW HOW PEOPLE ARE USING AND INTERPRETING THESE TESTS, AND WE DON'T KNOW IF THEY GO BACK TO THEIR PRIMARY CARE IF THE PROVIDERS THEMSELVES CAN PROVIDE, YOU KNOW, APPROPRIATE EDUCATION AND FOLLOW-UP. >> I CAN TELL ANECDOTALLY IN OUR COMMUNITY WHERE THIS IS BEING DONE A LOT, AND THEY'RE NOT NECESSARILY FOLLOWING UP ON MEDICAL GENETIC TESTING AND œINTERVENTIONS ARE BEINGICAL RECOMMENDED WILL AND PERFORM AND PERFORMED . SO THERE'S A REAL LIFE SIDE TO SOME OF THIS, AND IT'S SO IMPORTANT TO DO THIS RIGHT, AND I THINK THAT'S REALLY WHAT YOU'RE AIMING AT. SO JUST GIVING OTHERS BACKGROUND THOUGHTS FOR YOU. >> THANKS. >> KEVIN? >> ONE QUESTION THAT ALWAYS COMES UP ON THE PEDIATRIC SIDE ON THIS WHEN WE SEE A CHILD WHO'S GOT AN UNEXPECTED GERMLINE MUTATION IS OBVIOUSLY THE REPRODUCTIVE IMPLICATIONS FOR THE FAMILY WHICH YOU MENTIONED BUT ALSO THE EMPLOYMENT QUESTIONS PEOPLE ASK, STA GOING TO BE EXPLICITLY THOUGHT ABOUT IN TERMS OF WHAT SORT OF INFORMATION COUNSELORS ARE PROVIDING BACK TO THESE PEOPLE WHEN THEY ASK ABOUT WILL THIS AFFECT MY EMPLOYMENT, WILL I HAVE TO PUT THIS DOWN ON A JOB APPLICATION, WHAT MIGHT HAPPEN TO MY INSURANCE. I KNOW GINA EXISTS, BUT A LOT OF THE WORLD DOESN'T KNOW GINA EXISTS AND IT'S ALWAYS A QUESTION THAT WE WRESTLE WITH WHEN WE HAVE TO THINK ABOUT TALKING TO THESE FAMILIES. SO I JUST BRING THAT UP AS TO WHETHER THAT CAME UP IN ANY OF THE DISCUSSIONS WITH THE COMMITTEE OR INTERNALLY AT THE NCI AROUND SORT OF ECONOMIC -- POTENTIAL ECONOMIC IMPLICATIONS TO A PARTICULAR FAMILY OF SOME OF THESE DIAGNOSES. >> WE DIDN'T PARTICULARLY -- THAT'S NOT SOMETHING THAT WE LOOKED AT SPECIFICALLY. OBVIOUSLY IT'S EXTREMELY IMPORTANT. >> ANY FURTHER COMMENTS? OKAY. THEN DIANE, WOULD YOU LIKE TO MAKE A MOTION? >> I MOVE APPROVAL OF THIS CONCEPT. >> SECOND? OKAY. FURTHER DISCUSSION? OKAY. WE'LL HAVE A VOTE IN FAVOR TO APPROVE? DISAPPROVE? DEFER? OKAY. IT'S UNANIMOUS. THANK YOU VERY MUCH. WE'LL NOW MOVE TO RESEARCH TO DEVELOP EVIDENCE-BASED APPROACHES TO PATIENT ENGAGEMENT. THIS IS AN RFA COOPERATIVE AGREEMENT. DR. DEBBIE WINN IS PRESENTING. THANK YOU FOR COMING, DEBBIE. >> OKAY. I'LL BE PRESENTING ON AN RFA FOR RESEARCH TO DEVELOP EVIDENCE-BASED APPROACHES TO PATIENT ENGAGEMENT ON BEHALF OF THE MOONSHOT NETWORK FOR DIRECT PATIENT ENGAGEMENT TEAM, AS WELL AS THE CANCER DATA ECOSYSTEM IMPLEMENTATION TEAM. RECOMMENDATION A FROM THE MOONSHOT BLUE RIBBON PANEL CALLED TO ESTABLISH A NETWORK FOR DIRECT PATIENT ENGAGEMENT. IT HAD MULTIPLE KEY COMPONENTS, DIRECT PATIENT ENGAGEMENT WAS ONE BUT ALSO EXTENSIVE TUMOR SEQUENCING TO ENABLE PATIENTS TO BE ENROLLED IN CLINICAL TRIALS, ENGAGING PATIENTS TO CONTRIBUTE THEIR COMPREHENSIVE TUMOR PROFILE DATA, TO INFORM AND ADVANCE PRECISION MEDICINE. THEY NOTED THAT PATIENTS ARE EAGER TO PROVIDE THEIR DATA FOR THESE PURPOSES. THE PANEL CALLED FOR DATA SHARING, EXTENSIVE DATA SHARING, AND THE ABILITY TO PREREGISTER PEOPLE SO THAT -- INTO A NETWORK SO THAT THEY COULD BE CONTACTED LATER IF THEY BECAME ELIGIBLE FOR A STUDY, AN ALSO THEY STRONGLY ENCOURAGE THE NEED TO REACH MINORITY AND UNDERSERVED POPULATIONS. SO THE PANEL'S RECOMMENDATIONS WERE SWEEPING AND AMBITIOUS, AND WE THANK THEM FOR THAT, BUT TO ADDRESS THEM, WE TOOK THE APPROACH OF BREAKING THE COMPONENTS INTO MANAGEABLE AND MORE COMPLEMENTARY PIECES. WE DO HOPE THAT THE THREE INITIATIVES THAT YOU'RE GOING TO HEAR ABOUT INCLUDING MINE WILL HELP PROVIDE INSIGHT INTO AND INFORM THE DEVELOPMENT OF A LARGER NETWORK. SO THE BLUE RIBBON PANEL NOTED THAT THERE'S A CRITICAL NEED FOR RESEARCHERS TO ENGAGE DIRECTLY WITH PATIENTS, AND FOR THE PURPOSES OF THESE RFAs, WE'RE GOING TO BE DEFINING PATIENT ENGAGEMENT AS AN ONGOING BI-DIRECTIONAL AND MUTUALLY BENEFICIAL INTERACTION BETWEEN PATIENTS AND RESEARCHERS WHERE PATIENTS ARE INCLUDED AS AN INTEGRAL PART OF THE RESEARCH PROCESS AND BY EXTENSION ACROSS THE RESEARCH CONTINUUM FROM BASIC RESEARCH TO PRAGMATIC TRIALS. I WANT TO NOTE THAT OUR FOCUS IS ON ENGAGING PATIENTS TO BECOME PARTICIPANTS IN RESEARCH STUDIES, SO IT FOCUSES ON ENROLLMENT AND RETENTION. WE'RE NOT FOCUSING ON ENGAGEMENT FOR THE PURPOSE OF IMPROVING HEALTH OR FOR CLINICAL DECISION-MAKING. THESE ARE BEYOND THE SCOPE OF OUR PLANS RIGHT NOW. THE NEXT SLIDE, WE'LL PROVIDE YOU WITH WHAT WE ARE FOCUSING ON. THIS OUTLINES THETHREE PROJECTS YOU'RE GOING TO BE HEARING ABOUT. I'LL BE PRESENTING OBJECT FIRST BAR, RESEARCH TO DEVELOP EVIDENCE-BASED APPROACHES TO PATIENT ENGAGEMENT. IN THE DEMONSTRATION PROJECTS THAT YOU'LL HEAR ABOUT NEXT, THE GOALS ARE TO LEARN WHAT PATIENT ENGAGEMENT APPROACHES WORK BEST TO IDENTIFY AND ENROLL PATIENTS WHO ARE CHALLENGING TO RECRUIT THROUGH TRADITIONAL METHODS INTO A TUMOR SEQUENCING PLATFORM. AND THE GOAL OF THE THIRD INITIATIVE, THE PATIENT PORTAL, IS TO CREATE A COMMUNICATIONS CHANNEL THAT WILL BE PART OF CANCER.GOV'S OVERALL COMMUNICATION STRATEGY AND ITS FOCUS IS ON HELPING PATIENTS ACROSS THE COUNTRY HAVE AN ACCESSIBLE AND PATIENT-FRIENDLY GATEWAY INTO PARTICIPATING INTO RESEARCH STUDIES. SO NOW TO MY PROJECT, I WANT TO THANK DRS. -- I HOPE THE PURPOSE OF THE R FA FOR WE'RE PRESENTING IS TO BUILD THE KNOWLEDGE BASE ABOUT USING DIRECT PATIENT ENGAGEMENT TO IMPROVE PATIENT EXPERIENCES RELATED TO PARTICIPATION IN CANCER RE SECH STUDIES AND FOSTER PATIENT PARTICIPATION -- PARTICIPANT RECRUITMENT AND RETENTION FOR A NUMBER OF DIFFERENT TYPES OF STUDIES, AND I'LL TALK ABOUT THAT LATER, THAT COULD BE BROADLY APPLIED IN FUTURE RESEARCH STUDIES AND WITH A PRIORITY ON PARTICIPATION BY MINORITY AND UNDERSERVED POPULATIONS. SO ENGAGING PATIENTS AS PARTICIPANTS IN RESEARCH STUDIES IS VERY COMPLEX. THERE ARE MANY BARRIERS AND FACILITATORS, AMONG THEM ARE COGNITIVE ONES SUCH AS HEALTH LITERACY, THERE ARE OPPORTUNITY FACTORS SUCH AS BEING OFFERED AN OPPORTUNITY TO PARTICIPATE IN THE RESEARCH STUDY, THERE ARE MULTIPLE SOCIODEMOGRAPHIC CHARACTERISTICS SUCH AS AGE, GENDER, RACE AND ETHNICITY. THERE ARE MOTIVATIONAL FACTORS SUCH AS, FOR EXAMPLE, THE RETURN OF VALUE FROM PARTICIPATION OF THAT THE PATIENT PERCEIVED WILL OCCUR AS A RESULT OF THEIR PARTICIPATION, AND THEN THERE ARE ENVIRONMENTAL OR EEK LOGICAL FACTORS TO THE PATIENT'S FAMILY, COMMUNITY, HEALTHCARE PROVIDER AND SYSTEMS THAT INFLUENCE ALL OF THIS. MOST OF THE RESEARCH IN THESE AREAS ARE FOCUSED ON A SINGLE OR JUST A FEW OF THESE CHARACTERISTICS, AND A LOT OF THE WORK IN THIS AREA IS QUITE SILOED. TO GIVE YOU AN EXAMPLE OF UNDERSTANDING DISPARITIES AND ENGAGEMENT IN RECRUITING AND RETAINING PEOPLE INTO CANCER STUDIES IS THIS EXAMPLE FROM SUSAN EGLEY, AND THE BARS REPRESENT THE TIME IN MINUTES THE PATIENT AND THEIR ONCOLOGIST SPENT IN CONVERSING ABOUT THE ELEMENTS OF RISK IN A CONSENT FORM. AND THE LOWER BARS FOR THE BLACK PATIENTS SHOW THAT FOR NEARLY ALL OF THE ELEMENTS OF CONSENT, THE TIME SPENT BETWEEN THE TWO IN THESE IMPORTANT DISCUSSIONS WAS LOWER FOR THE BLACK PATIENTS THAN FOR THE WHITE PATIENTS. NOW I'LL GIVE YOU AN EXAMPLE OF POSSIBLE INTERVENTION STUDY. IT IS ALSO BY THE EGGLEY GROUP, BUT I HAVE LOOSELY INTERPRESENTED -- THIS IS A HYPOTHETICAL EXAMPLE JUST LOOSELY BASED ON THEIR STUDY TO GIVE YOU AN IDEA OF AN INTERVENTION STUDY. SO LET'S IMAGINE THAT THIS IS AN ONCOLOGIST PATIENT COMMUNICATION EFFORT ABOUT WHETHER THE PATIENT SHOULD ENROLL IN A TRIAL. THE PATIENT MIGHT BE IN THE INTERVENTION ARM PROVIDD WITH A PROMPT LIST OF QUESTIONS THEY COULD ASK THEIR ONCOLOGIST AND THEY WOULD BE ASKED TO READ A BROCHURE TALKING ABOUT PATIENTS AND PHYSICIANS HAVEING EQUAL IMPORTANT ROLES TO BENEFIT THE PATIENT. AT THE SAME TIME THE INTERVENTION COULD INVOLVE PHYSICIAN TRAINING ON UNCONSCIOUS RACIAL BIAS AND COMMUNICATION SKILLS. OUTCOMES COULD INCLUDE THE ULTIMATE ENROLLMENT OF THE PATIENT IN CLINICAL TRIAL BUT THERE ARE PATIENT CENTRIC OUTCOMES THAT SHOULD ALSO BE CONSIDERED, FOR EXAMPLE, THE PATIENT'S UNDERSTANDING OF THE TRIAL BEING OFFERED, OTHER SECONDARY OUTCOMES COULD BE THE PHYSICIAN'S PERCEPTION ABOUT THEIR ABILITIES TO COMMUNICATE AND THE PATIENT'S COMPLETION OF THE ENROLLMENT PROCESS OR THE PATIENT'S CONSIDERATION OF WHAT WAS INVOLVED IN ENROLLING IN THE STUDY. SO THERE ARE GAPS AND CHALLENGES IN A LOT OF THE RESEARCH STUDIES, MOST OF IT IS DESCRIPTIVE, THERE ARE SOME INTERVENTION STUDIES BUT FOR THE MOST PART, NOT A WHOLE LOT OF HYPOTHESIS-DRIVEN WORK. THERE ARE SOME ENGAGEMENT RESEARCH STUDIES THAT HAVE METHOD LOGIC LIMITATIONS, ABSENCE OF A CONTROL GROUP, THERE'S INSUFFICIENT PROGRESS IN ADDRESSING DISPARITIES IN PARTICIPATION AND RESEARCH STUDIES. PATIENTS' PERSPECTIVES WERE NOT FULLY INCORPORATED AND NOT USUALLY PART OF METRICS OF SUCCESS. NEW TECHNOLOGICAL AND INNOVATIVE APPROACHES ARE NOT WELL STUDIED, AND INTERVENTIONS THAT WE KNOW WORK DO NOT NECESSARILY GET BROADLY APPLIED. SO WE BELIEVE THAT PATIENT ENGAGEMENT RESEARCH COULD LEAD TO IMPROVED PARTICIPATION IN CANCER RESEARCH STUDIES. SO WE'RE PLANNING AN RFA FOR COOPERATIVE AGREEMENTS, WE EXPECT ABOUT FIVE WAIRDZ TO BE FIVE AWARDS WOULD BE MADE TO FILL KNOWLEDGE GAPS TO UNDERSTAND HOW BETTER -- INFLUENCE PATIENT ENGAGEMENT, DEVELOP AND TEST EFFICACY OF INTERVENTIONS TO IMPROVE PATIENT ENGAGEMENT, ESPECIALLY AMONG THE UNDERSERVED, EXPLORE STRATEGIES TO OVERCOME BARRIERS TO ADOPTION, ADAPTATION, SCALABILITY, SO THIS IS MORE OF AN EXPLORATORY AIM, NOT A FULL BORE IMPLEMENTATION SCIENCE STUDIES. AND APPLICANTS MAY ADDRESS ONE OR MORE OF THESE GOALS. THEY SHOULD FOCUS ON PATIENT ENGAGEMENT APPROACHES, PATIENT-CENTERED OUTCOMES MUST BE PART OF THIS AND, IF APPROPRIATE, ALSO THE ULTIMATE ENROLLMENT AND RETENTION STUDIES IF APPROPRIATE, MULTILEVEL CONTRIBUTORS. THESE INTERVENTIONS COULD -- WITH THE PATIENTS, WITH THE HEALTHCARE PROVIDERS AND HEALTHCARE PRACTICES OR ALL THREE. THE TYPES OF STUDIES, WE WOULD LIKE TO HAVE IT INCLUDE, A RANGE OF STUDIES SUCH AS BIOBANKING, NATURAL HISTORY STUDIES, EPI CANCER PREVENTION TRIALS -- TREATMENT TRIALS AND SURVIVORSHIP STUDIES, THE OUR SUBCOMMITTEE SUGGESTED A MORE NARROW FOCUS PERHAPS TO CLINICAL TRIALS, NOTING THE SMALL NUMBER OF AWARDS THAT MIGHT BE MADE IN CONCENTRATING EFFORT IN ONE PARTICULAR AREA. ON THE OTHER HAND, WE WERE ALSO CONCERNED THAT THERE ARE AREAS SUCH AS BIOBANKING THAT HAVE RECEIVED VERY FAR LESS ATTENTION AND HAS THEIR OWN PARTICULAR ISSUES AS WELL AS FOR SOME OF THESE OTHER AREAS SO WE WOULD LIKE TO SEE IT EXPANDED. WE ALSO BELIEVE THAT ALTHOUGH STUDIES ARE VERY DIFFERENT IN THE VAL EU THE EFFORT PEOPLE HAVE TO 50 THROUGH TO BE PARTICIPANTS, BUT THAT THERE ARE SOME COMMONLITIES IN TERMS OF PROCESSIONS ABOUT RETURN OF VALUE FROM THE PATIENT'S PARTICIPATION IN OTHER PATIENT-CENTRIC CONSIDERATIONS. THESE MUST INCLUDE A STRONG COMPONENT ON MINORITIES AND UNDERSERVED, AND WE HAVE PLANNED SOME COLLABORATIVE STUDIES. I'M JUST GOING TO TALK ABOUT THREE EXAMPLES OF POTENTIAL RESEARCH QUESTIONS. ONE MIGHT BE WHAT MOTIVATES PATIENTS TO PARTICIPATE IN CANCER RESEARCH STUDIES AND WHY. A SECOND, WHAT ARE PATIENTS PREFERENCES REGARDING METHODS OF BEING ENGAGED AND HOW CAN WE ENSURE THAT THOSE WAYS ARE CONSISTENTLY A LINED WITH PEOPLE'S VALUES AND GOALS, AND THEN FINALLY, FOR EXAMPLE, AT THE BOTTOM, WHAT'S THE BEST MODEL FOR COLLABORATIONS AMONG CANCER RESEARCHES, CLINICIANS AND CAREGIVERS AND PATIENTS TO ENSURE THAT PATIENTS REMAINED ENGAGED THROUGHOUT THE RESEARCH PROCESS. SO WE FOUND 24 GRANTS THAT USE PATIENT ENGAGEMENT STRATEGIES IN THE PORTFOLIO, BUT THESE WERE IN THE CONTEXT OF HEALTHCARE DECISION-MAKING AND HEALTH OUTCOMES. ONLY ONE OF THEM ADDRESSES -- THAT'S FROM THE EGGLEY GROUP, ADDRESSES PATIENT ENGAGEMENT IN PARTS PAYING IN CANCER RESEARCH STUDIES. ALSO FOUNDED ON THE BASIS OF PATIENT ENGAGEMENT AND ALSO HIGHLY FOCUSED ON PATIENT ENGAGEMENT BOTH FOR HEALTH OUTCOMES AND CLINICAL DECISION-MAKING AND ALSO FOR PATIENT ENGAGEMENT IN ALL ASPECTS OF THE RESEARCH PROCESS. THEY DON'T CURRENTLY HAVE ANYTHING EXACTLY LIKE THIS WHICH IS FOCUSING MUCH MORE NARROWLY, BUT I SHOULD ALSO NOTE THE THAT WE HAVE BEEN IN TOUCH WITH OUR COLLEAGUES OVER IN P CORY AND WE'LL BE COORDINATING WITH THEM. WE CANNOT CO-FUND THAT WITH THEM BECAUSE THEY'RE NOT A FEDERAL INSTITUTION. WE ALSO NOTE THAT NCI SUPPORTS A LOT OF ACTIVITIES THAT WORK ON PARTICIPANT ENGAGEMENT IN SPECIFIC STUDIES TO SOLVE PROBLEMS OF GETTING PATIENTS INTO SPECIFIC STUDIES, AND THESE ARE COMMUNITY OUTREACH EDUCATIONAL PROGRAMS, BEST PRACTICES, BUT THEY'RE NOT INTENDED AS GENERALIZABLE SCIENTIFIC FINDINGS UNLIKE WHAT WE'RE PROPOSING HERE, BUT THIS ALL SUGGESTS THERE'S A LOT OF INVESTIGATORS WHO COULD APPLY TO THIS. WE'RE PLANNING FIVE AWARDS WITH A TOTAL COST OF $500,000 EACH PER YEAR, WHICH RESULTS IN $2.5 MILLION IN EACH OF FISCAL YEARS '19 TO '23 FOR A TOTAL OF $12.5 MILLION. WE ALSO ARE INTEGRATED ACROSS WHAT WE'RE CALLING DISCOVERY SCIENCE RESEARCH PROGRAM, SO WE DO PLAN A CONTRACT COORDINATING CENTER TO HELP US COORDINATE ACROSS THIS AND ALSO TO SHARE BEST PRACTICES. IF YOU LOOK AT THE BOTTOM LEFT, THIS RESEARCH INITIATIVE IS WILL GOING TO HAVE COMMAND CON ADMINISTRATIVE SUPPLEMENTS AVAILABLE TO ANYONE IN THE RESEARCH COMMUNITY WHO QUAL POO GUYS TO SUBMIT AN ADMINISTRATIVE SUPPLEMENT AND WE'RE ALSO PLANNING OR HAVING WORKSHOPS THAT ARE MOSTLY AGENDA-SETTING WORKSHOPS TO FURTHER THIS INITIATIVE. FINALLY THE CRITERIA FOR SUCCESS, WE HOPE THIS WILL RESULT IN STRONG EVIDENCE OF BARRIERS AND FACILITATORS THAT INFLUENCE PATIENT ENGAGEMENT IN RESEARCH STUDIES, AND HOPEFULLY FIND FUNDAMENTAL INSIGHTS INTO BEHAVIOR AND MOTIVATION OF PATIENTS AND OTHERS AND INFORM FUTURE INTERVENTIONS. WE HOPE TO LEARN MORE ABOUT THE BASIS FOR DISPARITIES AND WHAT WE CAN DO ABOUT IT. WE WANT TO FIND OUT ABOUT EFFICACY OF INTERVENTIONS THAT ENABLE PATIENTS TO BE MORE CONFIDENT IN MAKING DECISIONS ABOUT THEIR PARTICIPATION IN RESEARCH AND THEN WE'LL BE READY FOR BROAD IMPLEMENTATION. SO -- AND WE HOPE THAT THIS EVIDENCE WILL BETTER INFORM THE BROADER IMPLEMENTATION OF RECOMMENDATION A. THANK YOU. >> THANK YOU VERY MUCH FOR THE PRESENTATION. WE HAD A SUBCOMMITTEE CONSISTING OF MYSELF AS CHAIR, DR. EMMONS AND DR. COLDITS. WE'LL START WITH SOME COMMENTS FROM US AND THEN OPEN IT UP FOR A DISCUSSION. SO I THINK WE ALL ACKNOWLEDGE THIS IS A VERY IMPORTANT AREA, ENGAGING PATIENTS IN THE RESEARCH ENTERPRISE THROUGHOUT THE CONTINUUM OF DEVELOPMENT ALL THE WAY THROUGH CONDUCT OF RESEARCH IS ESSENTIAL. THE NCI HAS LED THE WAY IN HAVING PATIENT INVOLVEMENT IN MANY DIFFERENT WAYS IN THE RESEARCH ENTERPRISE AND WE THINK THAT TAKING THIS TO THE NEXT STEP TO ENGAGE PATIENTS IS VITALLY IMPORTANT AND THE SENTIMENT REALLY RESONATES WITH US. I AM A LITTLE BIT CONCERNED THAT SOME OF THE REALLY KEY RECOMMENDATIONS THAT THE PANEL MADE IN THIS CASE DIDN'T SEEM TO MAKE IT INTO THE PRESENTATION, AND MAYBE WE CAN GO THROUGH SOME OF THOSE AND WHAT I'LL DO IS I MIGHT JUST GO THROUGH THEM QUICKLY AND LET THE OTHERS ADD TO THAT AND THEN MAYBE IF YOU WANT TO RESPOND TO THAT, I THINK THAT WOULD BE OKAY. THE FIRST IS, WE REALLY DID FEEL THAT SCOPE WAS VERY BROAD. I THINK THIS IS A SMALL BUDGET CONSORTIUM OF A SMALL NUMBER OF CENTERS AND INCLUDING PATIENT ENGAGEMENT AND OBSERVATIONAL STUDIES, BIOBANKING PREVENTION, CLINICAL TRIALS, YOU KNOW, WE JUST FELT IT WAS REALLY BROAD IN THE TECHNIQUES -- AND THE TECHNIQUES MAY VARY SUBSTANTIALLY. YOUR CONCERN ABOUT NOT GETTING APPLICANTS RESONATES BUT AT THE SAME TIME, WE REALLY FELT THAT MAYBE STARTING WITH THE NARROWER FOCUS, PERHAPS JUST CLINICAL TRIAL ACCRUAL AND RETENTION AND HOW PATIENTS ARE ENGAGED MIGHT, YOU KNOW, GIVE YOU SOMETHING MORE COHERENT SO YOU COULD DEVELOP A TOOLBOX THAT COULD BE USED, AND THEN MAYBE EXPAND FROM THERE, OR MAYBE DO TWO CONTACTS, WE FELT IT WAS BROAD. THE SECOND IS THAT WE WEREN'T CLEAR IF THIS IS REALLY A FOCUS ON DISPARITIES OR IF THIS IS A FOCUS JUST ON PROBLEMS WITH ENGAGES PATIENTS AND AKREUT IN GENERAL. WHAT IS OUR GOAL? IS IT TO NARROW DISPARITIES AND CREATE EQUITY THE IN ACCRUAL TO TRIALS OR IS IT JUST SIMPLY TO ADDRESS THIS ISSUE YOU THAT MANY PATIENTS DON'T GET ENROLLED? THEY'RE OBVIOUSLY CONNECTED BUT I THINK THAT, YOU KNOW, A FOCUS WOULD BE TSH >> WE >> -- >> WE DIDN'T WANT TO SAY YOU MUST BE FOCUSING ON A DISPARITIES ISSUE. WHAT WE'RE CALLING FOR, ALTHOUGH WE WOULD BE PERFECTLY RECEPTIVE TO THAT, WE THOUGHT THAT THE ISSUES ARE GENERALIZABLE TO MANY POPULATIONS BUT IT WOULD REQUIRE THAT APPLICANTS FOR THE RFA HAVE A VERY STRONG COMPONENT IN MINORITIES AND HEALTH DISPARITIES, MEANING ANYONE THAT REALLY HAD SOMETHING WEAK OR NOT THE A ALL OR DID NOT FULLY ADDRESS THAT WOULD NOT BE SCORED WELL AND NOT MUCH IN THE RUNNING. HOWEVER, WE'D BE TOTALLY HAPPY TO MAKE MAKE A HARD AND FAST MUST -- IS REQUIRED TO HAVE TO FOCUS ON DISPARITIES. WE COULD GO EITHER WAY. >> MAYBE THAT WILL BE DRAWN OUT IN THE DISCUSSION A LITTLE BIT. THE THIRD WAS REALLY AROUND THE PRIMARY GOAL OF THESE KINDS OF PATIENT ENGAGEMENT INTERVENTION INTERVENTIONS, AND I THINK IT WAS OUR FEELING THAT ALTHOUGH COMMUNICATION AND ENGAGEMENT -- LARGE IS VERY IMPORTANT, THAT AT THE END OF THE DAY, WE WANT ACCRUAL AND WE WANT RETENTION AND WE WANT STUDY PARTICIPANTS TO UNDERSTAND THE GOALS, THE RISKS, THE BENEFITS OF THE TRIALS SO WE DID FEEL THAT THOSE KINDS OF END POINTS WOULD IDEALLY BE HIGHLIGHTED, AND YOU DID ALLUDE -- SOME OF THAT DID MAKE IT IN. >> THAT'S EXACTLY WHAT WE INTEND. >> YEAH. AND THEN THE LAST ONE THAT I'LL TOUCH ON, THEN MAYBE I'LL TURN IT TO KAREN, WAS AROUND THE BUDGET. I THINK THIS ISN'T REALLY -- THIS IS LESS A CRITIQUE OF THE PRESENTATION. WE DID FEEL THAT TOTAL COST OF $500,000 PER SITE GIVEN THE VERY, YOU KNOW, SUBSTANTIAL MANDATE, IT COULD PRESENT CHALLENGES TO POTENTIAL APPLICANTS AND MIGHT DISSUADE STRONG APPLICANTS FROM APPLYING TO THIS MECHANISM. I'LL TURN TO KAREN. >> I'LL JUST AMPLIFY THE ISSUE RELATED TO DIVERSITY AND DISPARITIES. THE ISSUE THAT WE WERE CONCERNED ABOUT THERE, AND I THINK WE TALKED ABOUT THIS A BIT ON THE CALL, IS THAT IF WE'RE JUST TRYING TO GET PEOPLE IN AND THEN WE IGNORE WHETHER OR NOT WE'RE EFFECTIVELY KEEP KEEPING THEM IN THE TRIAL, WE'RE ADHERING TO WHAT THEY'RE ASKING THEM TO DO, WE'RE SATISFIED WITH THEIR EXPERIENCE, WE'RE JUST WASTING AN OPPORTUNITY SO THAT'S WHY I THINK THAT WHOLE CASCADE IS SUPER IMPORTANT. I THINK REALLY WORTH CLARIFYING. SO I GUESS FOR ME -- >> IT'S NOT ABOUT THE NUMBERS OF PEOPLE GETTING INTO THE STUDY. IT'S ABOUT THEIR ENTIRE EXPERIENCE AND THEY'RE BEING ABLE TO MAKE AN INFORMED DECISION. AND FINDING VALUE IN THEIR PARTICIPATION THAT ENABLES THEM TO STAY IN THE STUDY. >> AND GET THE FULL BENEFIT OF THE TREATMENT. I THINK THAT'S SUPERB, AND I WOULD OH BRING WOULD BRING THAT BACK UP TO THE ISSUE OF THE VERY AMBITIOUS NATURE OF THE SCOPE. TO ME, THOSE ARE ACTUALLY IN MANY WAYS VERY DIFFERENT THINGS YOU'RE ASKING THE CENTERS TO DO, GETTING PEOPLE IN,, INCREASING SATISFACTION, SO THAT TO ME NARROWS THE SCOPE A BIT SO IT'S MUCH MORE FOCUSED. >> THANK YOU. GRAHAM? >> MUCH TO PROVIDING INPUT THAT'S REFLECTED IN THIS DISCUSSION ALREADY, THE SCOPE AND FOCUS ON DISPARITIES FEELS LIKE WE DON'T WANT TO UNDERSTATE THE DISPARITIES PIECE. I HEARD A PUSHBACK THAT WE DON'T WANT IT TO BE ONLY DISPARITIES DRIVEN, BUT WORKING A WAY TO NARROW TOWARDS THAT MIGHT ADDRESS SOME OF THE CONCERNS OF THE BREADTH HERE, SINCE THAT REALLY IS FUNDAMENTAL TO BRINGING ALL OUT DISCOVERIES TO THE POPULATION SUBGROUPS IN THE COUNTRY. >> WE'LL OPEN IT UP. >> SO AGAIN I HAVEN'T READ THE FULL RFA, BUT JUST SPEAKING FROM THE EXPEIENCE OF WORKING WITH OUR OWN POPULATION, CERTAINLY WITH OUR TRIBAL NATIONS THAT REALLY WANT TO HAVE FORMAL CONSORTIUM AGREEMENTS. ONE IS SUBMIT VIA SPECIMENS, ONE -- SCIENCE, WITH ONE CAVEAT: PROTECT MY INDIVIDUAL GENETIC IDENTITY BECAUSE IT'S MY SOCIAL AND CULTURAL I'D I SO IF WE IDENTITY. SO IF WE CAN GET THERE, THAT'S GREAT. BUT THE CHALLENGE IN COLLECTING -- WE'RE COLLECTING A LOT OF BIOSPECIMENS FROM THEM, IS THERE NEEDS TO BE A PURPOSE CLEARLY DEFINED, SO THE IDEA THAT WE'RE GOING TO DO OPEN-ENDED BIOSPECIMEN COLLECTION WOULD MAKE THEM WALK OUT OF THE ROOM. SO I REALLY FEEL THAT THIS HAS TO HAVE A DISPARITIES FOCUS, AND IT OUGHT TO BE TREATED OR TIED TO SOME SORT OF INTERVENTION. AND THIS IS TOTALLY THINKING OFF THE TOP OF MY HEAD, BUT IT SEEMS RATHER -- SINCE YOU HAVE A FOCUSED AMOUNT OF FUNDING FOR THE RFA, IT WOULD BE BEAUTIFUL TO ACTUALLY TIE THIS TO SOME NATIONAL NCI THE NCTN STRIEL LIKE THE NEXT MATCH STUDY, WHERE WE WOULD ALL BE KIND OF WORKING OFF THE SAME PLATFORM WITH THE SAME SORT OF CONSENT CRITERIA BUT EXAMINING HOW WE BRING MINORITY PATIENTS TO THAT STUDY IN A MORE EFFECTIVE WAY. I THINK THAT COULD MAKE THIS SORT OF GET OVER THE ISSUE OF IT KIND OF BEING BROAD AND DEFINED, MAYBE IT NEEDS TO BE DISPARITIES FOCUSED, BUT IT'S ACTUALLY A HUGE PROBLEM THAT WE SEE EVERY DAY, AND I'M SURE MANY OTHER FOLKS AROUND THE NATION DO AND THE PATIENTS THEY'RE TRYING TO BRING IN TO STUDIES WE REALLY WANT THEM TO PARTICIPATE IN. SO THAT MAY BE TOTALLY OFF THE WALL, BUT IT WOULD BE HUGE IF WE COULD ACTUALLY ACHIEVE THAT AND THINK ABOUT THAT. >> ONE THING IN TERMS OF GIVING PEOPLE THE VALUE FOR SOMETHING LIKE BIOSPECIMEN BANKING WOULD BE -- AND SOME PEOPLE ARE DOING THIS ALREADY, PROVIDING PEOPLE BACK NOT ONLY NEWSLETTERS AND BIG PICTURE OF WHAT HAS TRANSPIRED IN THAT SYSTEM, BUT WHAT ARE THE OF THE ACTUAL PATIENT'S SPECIMENS WERE USED, AND BRINGING THAT INFORMATION BACK TO -- >> THESE THEAS MY RECOMMENDATION OF TYING THIS TO A SPECIFIC STUDY, I THINK YOU COULD GO FULL CIRCLE, BECAUSE AGAIN, WHY AM I COLLECTING THE TISSUE, WHAT'S THE -- MOST OF OUR PATIENTS DON'T HAVE TROUBLE UNDERSTANDING THEY'RE GOING TO BE IN DIFFERENT ARMS OR WE DON'T KNOW WHAT THE OUTCOME IS YET, BUT SOMEDAY YOU'RE GOING TO TELL ME -- >> WHAT CAME FROM IT. >> SO I THINK FOCUSING PERHAPS ON THIS AS AN OPPORTUNITY TIED TO SOME SPECIFIC OTHER INITIATIVE THAT COULD BE AN INTERVENTIONAL TRIAL OF SOME SORT, I LIKE THE PRECISION MEDICINE IDEA, OR ANY TRIAL REALLY, WOULD ALLOW YOU TO COME BACK FULL CIRCLE TO THAT COMMUNITY AND STUDY ACTUALLY BEST MODES OF FOLLOW-UP COMMUNICATION OF RESULTS, WHICH I WOULD ARGUE WE'RE EQUALLY BAD AT, OR UNDERSTANDING WHAT THEIR EXPERIENCE WAS DURING THE COURSE OF THAT TRIAL. OR IMPLEMENT THOSE TRIALS MORE EFFECTIVELY SO THEY ACTUALLY STAY ON THE TRIAL AND COMPLETE. SO IT WOULD BE INTERESTING IF WE COULD DO IT THIS WAY. I REALIZE WE NEED TO PUT OUT RFAs THAT SORT OF SEEK IDEAS, BUT -- AND I'M THE BIGGEST COMPLAINER WHEN WE DIRECT SCIENCE, BUT I ACTUALLY THINK IN THIS EXAMPLE PICKING A COMMON PLATFORM AND DIRECTING THE INFRASTRUCTURE THAT WE'RE TYING THE SCIENCE TO WOULD REALLY BE HELPFUL. >> THANKS. WE'LL GO TO ELECTRA. >> THANKS. THANKS, DEB, FOR THAT PRESENTATION. I'M GOING TO SORT OF CARRY ON A LITTLE BIT OF WHAT CHERYL IS TALKING ABOUT. SO I'LL START WITH A LITTLE BIT OF CONFUSION. SO I'VE BEEN WORKING IN THIS AREA, WHY PEOPLE PARTICIPATE IN CLINICAL TRIALS, SINCE ABOUT 1989, AND THERE'S BEEN A LOT OF RESEARCH DONE IN THIS IN THE PAST. WE KNOW WHY PEOPLE DON'T PARTICIPATE IN TRIALS, WE KNOW WHY MINORITY OR DIVERSE POP POPULATIONS DON'T PARTICIPATE IN TRIALS. WE KNOW THAT. SO WE USED TO CALL IT PARTICIPATION. WHEN YOU TALK ABOUT ENGAGEMENT, WHAT YOU TALKED ABOUT IS NOT WHAT I THINK ABOUT ENGAGEMENT. ENGAGEMENT IS ASKING PEOPLE WHAT STUDIES THEY WOULD LIKE TO SEE, HOW THEY WOULD LIKE TO BE APPROACHED. THAT'S NOT REALLY REFLECTED IN THE MISSION OF THIS UO1, IT REALLY ISN'T. IT'S REALLY PARTICIPATION, HOW CAN YOU INCREASE PARTICIPATION OF PEOPLE, ESPECIALLY DIVERSE POPULATIONS, IN YOUR RESEARCH PROPOSAL -- I MEAN IN YOUR RESEARCH STUDIES? THAT'S WHAT YOU WANT TO DO. IT'S REALLY NOT PATIENT ENGAGEMENT. AND YOUR DEFINITION OF PATIENT ENGAGEMENT, I READ THREE TIMES THIS MORNING, AND IT IS NOT WHAT YOU'RE SAYING. YOU ARE REALLY LOOKING AT PARTICIPATION. AND THERE'S A WHOLE FACTOR THAT YOU HAVE NOT INCLUDED IN THIS, WHICH IS ACTUALLY THE BIGGEST REASON WHY PEOPLE DON'T PARTICIPATE AND WHY DIVERSE POPULATIONS DON'T PARTICIPATE. AND THAT'S BECAUSE WE WRITE OUR PROTOCOLS TO DISPROPORTIONATELY EXCLUDE PEOPLE FROM MINORITY GROUPS AND DIVERSE POPULATIONS. AND IT DOESN'T MATTER IF YOU HAVE 400 PROTOCOLS AT YOUR INSTITUTION. IF YOU HAVE MINORITY MEN IN YOUR POPULATION WHO HAVE BEEN PRE-TREATED ELSEWHERE BECAUSE THEY'VE GON TO THEIR COMMUNITY FOR TREATMENT OR THEY HAVE CHRONIC, YOU KNOW, COMORBIDITIES THAT EXCLUDE THEM, YOU ARE NOT GOING TO GET THEM TO BE ENGAGED OR PARTICIPATE IN YOUR STUDY. SO WE HAVEN'T FIXED THE ROOT PROBLEM, WHICH IS THE PROTOCOLS WE WRITE. NUMBER ONE REASON, YOU WILL GET 60% OR MORE OF PATIENTS INELIGIBLE BECAUSE OF THAT. THE SECOND IS THE PROVIDERS DON'T ASK THEM. THOSE ARE THE BIGGEST PROBLEMS. ONCE YOU GET TO THE PATIENT, THEY'LL PARTICIPATE. THAT'S NOT THE PROBLEM. THAT IS NOT THE PROBLEM. THE FIRST TWO ARE THE PROBLEMS. AND THE WORK BY THE KARMONOS FOLKS ABOUT PERCEIVED BIAS AND ALL THAT, THAT'S FABULOUS, AND THAT COULD HELP WITH ASKING PEOPLE, BUT WE'RE NOT ADDRESSING THE ROOT PROBLEM. AND I CHAIR THE ALLIANCE HEALTH DISPARITIES COMMITTEE AND WE ARE WORKING ON TRYING TO ACTRESS THIS. THERE'S ALL THE HEALTH DISPARITIES IN THE COOPERATIVE GROUPS THAT ARE TRYING TO ADDRESS THIS, BUT THIS U01 DOES NOT ADDRESS THE RAO OF ROOT OF THE PROBLEM, I'M AFRAID IT'S REALLY NOT. AND LAST THING I'LL SAY, YOU'VE GOT TO FOCUS ON INTERVENTION. WE KNOW WHY. YOU'VE GOT TO TAKE WHAT WE KNOW AND MOVE TO INTERVENTION. IT'S NOT GOING TO HELP US ANYMORE TO SPEND MONEY TO UNDERSTAND WHY. WE KNOW WHY. >> I'M GOING TO TURN TO JIM, WHO'S BEEN WAITING, AND THEN TO ELANA, AND THEN WE'LL TAKE ONE MORE TODAY. >> [INAUDIBLE] >> YEAH, IT IS A THEME THAT'S COME UP MULTIPLE TIMES THIS MORNING. CHERYL, I THOUGHT YOUR COMMENTS WERE SPOT-ON. DEBBIE, THE PRESENTATION OUTLINED THE UNIVERSE OF THIS BIG CHALLENGE. BUT I THINK THE TENSION I SEE AND THE CONCEPT IS HOW CAN YOU FIND THE RIGHT BALANCE OF BROAD VERSUS DEEP -- REALLY, I LOOK AT ENGAGEMENT PARTICIPATION AS ALMOST CUSTOMER SERVICE. I WISH THE BLUE RIBBON PANEL WOULD HAVE COME OUT AND SAID WHAT WE REALLY NEED IS SORT OF AN EER, AN ELECTRONIC ENGAGEMENT RECORD, WHICH MEANS AS A FIELD TRACKING EVERY DATA POINT AND PUTTING DATA ON EACH OF THOSE DECISIONS SO WE CAN ADDRESS THE ISSUE OF WHAT'S THE STATED PREFERENCE VERSUS ACTUAL BEHAVIOR. AND I THINK FOR THIS CONCEPT, LOOKING AGAIN AT THE IDEA OF FOCUSING ON A DOMAIN AND SAYING WE'RE GOING TO ASK RESPONDENTS TO COLLECT THE TYPE OF DATA NECESSARY SO THAT THOSE THINGS CAN BE BETTER UNDERSTOOD, AND IDENTIFY WHERE IN THIS MULTISTAGE PROCESS ARE PEOPLE LEAKING, I THINK THAT WOULD PROBABLY GET YOU FASTER PROGRESS, AND THEN MAKE THE SUBSEQUENT REACHES INTO THOSE OTHER AREAS EVEN BETTER INFORMED AND STRONGER. >> THANKS. WE'RE JUST GOING TO TAKE TWO MORE COMMENTS. >> SO I COMPLETELY AGREE WITH ELECTRA. WE HAD SOMEWHAT OF A DISCUSSION IN OUR CONCEPT ABOUT WHAT IS PATIENT ENGAGEMENT, AND WE NEED TO DEFINE IT. AND I THINK IN THE SETTING OF WE KNOW WHAT THE END REACH PROBLEMS AT EACH INSTITUTION ARE, WHAT THE OUTREACH ISSUES ARE, SO IS IT AN INREACH PROBLEM OR AN OUTREACH PROBLEM AND WE CAN DISCUSS THAT, BUT IN TERMS OF PATIENT ENGAGEMENT. ENGAGEMENT, THE ONE AREA THAT MAYBE COULD BE A POTENTIAL AND WE DISCUSSED THIS IN OUR CALL FOR THE OTHER RFA IS LIKE IN THE POPULATIONS THAT WE SERVE, WHICH IS HISPANIC, LOW INCOME, LOW LITERACY, SPANISH SPEAKING, THE PATIENT ENGAGEMENT COMPONENT THAT I FEEL WE HAVEN'T REALLY UNDERSTOOD IS, YES, THEY WILL CONSENT BUT THEY DON'T UNDERSTAND WHAT THEY'RE CONSENTING TO. AND I HAVE HAD THIS DISCUSSION EVEN IN A COOPERATIVE GROUP ABOUT ASSESSING UNDERSTANDING OF CONSENT, AND I WON'T SAY ANY NAMES, BUT THE PERSON TOLD ME, ALL WE KNOW, THEY DON'T UNDERSTAND AND WE DON'T WANT TO KNOW. RIGHT? AND SO MY RESPONSE TO THAT IS, THE PATIENT ENGAGEMENT, WE NEED TO UNDERSTAND HOW TO BETTER INFORM THE PATIENT SO THEY'RE ENGAGED WHEN THEY ARE APPROACHED WITH THE CONSENT. THAT IS MAYBE ONE AREA, AND WE WORK WITH PEDIATRIC ONCOLOGY, WITH THE PARENTS OF THE CHILDREN AND WHAT HAVE YOU, WE HAVE A WHOLE PROGRAM ON THIS, AND OUR EMPHASIS IS ON GETTING IN THIS CASE THE PARENTS AND MAYBE THE CHILDREN, DO THEY UNDERSTAND WHAT THEY'RE SIGNING UP FOR. I'LL STOP THERE. >> I'LL TAKE ONE MORE COMMENT. >> THANK YOU. I JUST WANTED TO AGREE, I THINK THIS IS TOO BROAD. I THINK FROM THE PATIENT STANDPOINT, THE DECISION-MAKING PROCESS TO ENTER INTO A TRIAL THAT DEALS WITH BIOBANKING VERSUS A CLINICAL TREATMENT TRIAL IS ENTIRELY DIFFERENT. AND I THINK THERE ARE TOO MANY FACTORS THAT DIFFER FROM THE PATIENT PERSPECTIVE. AND ALSO TO BRING IN A REAL WORLD CONCERN HERE, ONE OF THE PROBLEMS IN GIVING THE INFORMATION, THE SUFFICIENT INFORMATION TO THE PATIENTS TO GET THEM ENGAGED EITHER IN A CLINICAL TRIAL OR OTHERWISE IS TIME. AND WHERE IS THAT TIME GOING TO COME FROM? THE PHYSICIANS DON'T NECESSARILY HAVE IT, NOT ALL PHYSICIANS HAVE DEDICATED CLINICAL TRIALS NURSES OR ADMINISTRATORS, AND I THINK THAT'S SOMETHING THAT'S REALLY MISSING FROM THIS BECAUSE IF WE'RE GOING TO FILL THIS GAP, WE'VE GOT TO FIND THE TIME TO COMMUNICATE THE INFORMATION. AWBD FUND IT,AND FUND IT, YES. >> SO WE'RE GOING TO MOVE TOWARDS A VOTE. I THINK I'LL JUST MAKE A QUICK COMMENT BEFORE I MOVE TO THAT. FIRST OF ALL, I THINK YOU HAD AN INCREDIBLY CHALLENGING MANDATE HERE. I THINK WHAT YOU ARE HEARING IS TREMENDOUS ENTHUSIASM ABOUT A COMPLICATED PERENNIAL ISSUE THAT MAY NEED A MULTIPRONGED APPROACH. BUT IT'S NOT A LACK OF ENTHUSIASM FOR THE TOPIC THAT YOU'RE HEARING. WE APPRECIATE THE CHALLENGES OF ADDRESSING THIS. BECAUSE I'M SHARING, I'LL TURN TO DR. EE CHAIRING, I'LL TURN TO DR. EVANS TO MAKE A MOTION. >> THE NEED FOR SOME CONTINUED WORK ON THIS, I MAKE A MOTION THAT WE DEFER. >> SECOND? OKAY. SO THE MOTION IS TO DEFER, ALL IN FAVOR TO DEFER? ANY NAYS? OKAY. SO I'D JUST LIKE TO COMMENT THAT IN CASES OF DEFERRAL, -- OH, ANY ABSTENTIONS? IN SUCH CASES, YOU CAN WORK WITH A PANEL OF THREE BSA MEMBERS, FOR EXAMPLE, TO HELP TO FERRET OUT THE ISSUES A LITTLE BIT AND THEN BRING IT BACK TO THE BOARD. AND SO ARE THERE THREE VOLUNTEERS WHO WOULD BE INTERESTED? >> MOST OF US ARE -- >> CHERYL, JIM. >> I'M HAPPY TO HELP IN MY NON-BSA CAPACITY. >> ALL RIGHT. AND DIANE. WE'LL TAKE MORE THAN THREE. TERRIFIC. THANK YOU SO MUCH. WE HAVE FOUR. OKAY, PERFECT. GREAT, THANK YOU VERY MUCH. OUR FINAL CONCEPT FOR VOTING CONSIDERATION TODAY, RELATED CONCEPT, PATIENT ENGAGEMENT FOR PRIORITY CANCER SCREENING, WHICH IS RFA COOPERATIVE AGREEMENT, DR. MECHANIC IS PRESENTING. LEAH, THANK YOU FOR COMING. >> THANK YOU. ON MAF BEHALF OF OUR TEAM I APPRECIATE THE OPPORTUNITY TO PRESENT TODAY OUR CONCEPT, PATIENT ENGAGEMENT FOR PRIORITY CANCER SEQUENCING. SO THIS CONCEPT IS DESIGNED AS ONE OF THE DEMONSTRATION PROJECTS TO ILLUSTRATE HOW WE CAN USE PATIENT ENGAGEMENT TO SUPPORT DISCOVERY RESEARCH. THE GOAL OF THIS FUNDING OPPORTUNITY IS TO BUT SORT TARGETED DIRECT PATIENT ENGAGEMENT PROJECTS AND THIS IS BECAUSE A BLUE RIBBON PANEL NOTED THE IMPORTANCE OF DIRECTLY ENGAGING WITH PATIENTS IN RESEARCH. AND THE PANEL ALSO STATED THAT EFFORTS TO REACH MINORITY AND UNDERSERVED POPULATIONS SHOULD BE A HIGH PRIORITY. THROUGH THIS DIRECT PATIENT ENGAGEMENT, WE AIM TO GENERATE A COMPREHENSIVE GENOMIC LANDSCAPE OF THOSE CANCERS THAT ARE CURRENTLY POORLY CHARACTERIZED AND ADDRESS RESEARCH GAPS IN NCI PRIORITIES. SO THE CANCER GENOME ATLAS HAS BEEN VERY SUCCESSFUL AT CHARACTERIZING GENERAL CHARACTERIZATION OF CANCER BUT WE'RE AWARE THAT THERE ARE ALSO RESEARCH GAPS. LOOKING AT THE RACE DISTRIBUTION OF CANCERS FROM THE CANCER GENOME ATLAS, ONLY 14% OF THESE TUMORS COME FROM MINORITY POPULATIONS. EXAMINING THE ETHNICITY DISTRIBUTION, ONLY 3% OF THESE TUMORS COME FROM HISPANIC OR LAHTI FOE LATINO POPULATIONS. RESULTS SUCH AS THESE HAVE RESULTED IN SUBSTANTIAL GAINS IN THE UNDERSTANDING OF CANCER PREVENTION AND TREATMENT, YET THEIR GENERALIZABILITY TO ALL U.S. POPULATIONS IS LIMITED DUE TO LACK OF RACIAL AND ETHNIC DIVERSITY AND IT'S IMPERATIVE THAT THE CANCER MOONSHOT NOT REPEAT THIS IS HAD THIS HISTORY. SO ONE IS A DIRECT PATIENT ENGAGEMENT STRATEGY. WE'RE PROPOSING THE FOLLOWING MECHANISMS, THE PATIENT ENGAGEMENT WILL BE THROUGH COOPERATIVE AGREEMENTS,s DIRECT PATIENT ENGAGEMENT IN PRIORITY CANCER AREAS AND/OR UNDER STUDIED POPULATIONS, PATIENT ENGAGEMENT, REKREUPTMENT, TISSUE ACQUISITION, DATA COLLECTION, DATA ANALYSIS AND INTERPRETATION RETURN OF INFORMATION TO PARTICIPANTS. THE MOLECULAR CHARACTERIZATION AND DATA SHARING, NCI CENTER FOR CANCER GENOMICS PIPELINE, TISSUE PROCESSING MOLECULAR CHARACTERIZATION AND ANALYSIS, PLANNED CHARACTERIZATION, WHOLE EXOME SEQUENCING, WHOLE GENOME SEQUENCING, DNA NET METHYLATION AND RNA SEQUENCING, AND DATA TO BE SUBMITTED THROUGH BROAD DATA SHARING. SO I WANT TO GO INTO MORE DETAIL OF WHAT WE MEAN FOR THE PATIENT ENGAGEMENT REQUIREMENTS FOR OUR UO1 APPLICANTS, THEY MUST DEVELOP AN ENGAGEMENT PLAN THAT WILL BE EVALUATED IN PEER REVIEW AND THEY MUST INCORPORATE PATIENT INPUT THROUGHOUT THE RESEARCH PROCESS FOR THEIR PROGRAMS. ARE THEY MUST USE STATE OF THE ART CULTURALLY SENSITIVE AND APPROPRIATE METHODS OF ENGAGEMENT. AND THIS IS A CRITICAL COMPONENT BECAUSE WE KNOW IT'S BEEN CHALLENGING TO ENGAGE WITH THESE UNDERSTUDIED OR MINORITY POPULATIONS. WE'LL USE THE COORDINATING CENTER TO SERVE AS A CLEARINGHOUSE OF EXISTING RESOURCES AND BEST PRACTICES SUCH AS INFORMATION FROM THE CENTER TO REDUCE CANCER HEALTH DISPARITIES, AND ALSO TO FACILITATE INFORMATION SHARING ACROSS PROJECTS, AND YOU HEARD ABOUT THE INITIATIVE PRESENTED BY DEBBIE WINN AND DAVID CHAMBERS AND WHAT LESSONS WE CAN LEARN IN ENGAGING UNDERSTUDIED MOP POPULATIONS. THEY MUST MAINTAIN THE ABILITY TO RE-CONTACT PATIENTS AND THEY MUST PLAN REGULAR COMMUNICATIONS WITH PATIENTS BUT ALSO IMPORTANTLY LISTEN TO PATIENTS ABOUT FEEDBACK PRIORITIES AND CONCERNS, AND THE UO1s MUST PARTICIPATE IN BIANNUAL MEETINGS AND WEBINARS CENTERED ON PATIENTS. SO THIS FUNDING OPPORTUNITY WILL BE DESIGNED TO ADDRESS RESEARCH GAPS IN THE GENOME CHARACTERIZATION OF BOTH ADULT AND PEDIATRIC CANCERS. WE'LL OUTLINE OUR PRIORITY AREAS AND THEY INCLUDE RARE CANCERS, HIGHLY LETHAL CANCERS, CANCER SUBSETS WITH EARLY AGE OF ONSET, CANCERS WITH HIGH DISPARITIES AND CANCRS IN UNDERSTUDIED POPULATIONS. WE'LL ALSO -- ULTIMATELY THE PRIORITY AREAS WOULD BE SELECTED BASED ON SCIENTIFIC DISCUSSIONS AND PEER REVIEW, NCI PRIORITIES, AND A VERY CAREFUL REVIEW OF ALL ONGOING ACTIVITIES BOTH AT NCI AND IN THE RESEARCH COMMUNITY. SO AN IMPORTANT COMPONENT OF ENGAGING WITH PATIENTS IS THE RETURN OF INFORMATION TO PATIENTS. SO WE'RE LEVERAGING THE NCI CENTER FOR CANCER GENOMICS PIPELINE FOR RESEARCH AND, THEREFORE, THE SEQUENCING WILL BE PERFORMED AT A RESEARCH LABORATORY AND IS NOT A CLIA TEST AND THEREFORE NOT DIRECTED TO REPORT BACK TO PATIENTS. WE WILL VEL FOR THAT DEVELOP A POLICY SIMI LAR TO WHAT'S BEING USED FOR THE NCI MATCH AND OTHER PROJECT, BUT THIS AREA WILL EVOLVE AND THIS POLICY WILL BE PERIODICALLY EVALUATED SMED NAD, IN ADDITION, PATIENTS MAY RECEIVE SUMMARY OF INDIVIDUAL HEALTH INFORMATION, ONGOING UPDATES AND SUMMARY OF RESULTS. SO THERE ARE SEVERAL EVALUATION CRITERIA WE'LL USE TO EVALUATE THE SUCCESS OF THIS INITIATIVE. THIS INCLUDES PATIENT ENGAGEMENT METRICS AND SCIENTIFIC METRICS AND I'LL JUST HIGHLIGHT A COUPLE OF THEM THON SLIDE. IT'S IMPORTANT THAT PATIENTS FEEL RESPECTED, EMPOWERED AND MOTIVATED TO PARTICIPATE IN THIS INITIATIVE, INCLUDING THEIR CONFIDENCE AND ABILITY TO MAKE DECISIONS ABOUT THEIR PARTICIPATION IN THIS RESEARCH PROJECT, THE EASE OF PATIENTS FOR PROVIDING ACCESS TO CLINICAL DATA AND TISSUE SPENCE SPES MENS TO THIS PROGRAM, AND WHETHER OR NOT PATIENTS UNDERSTAND HOW AND WHERE THEIR TISSUE SPECIMENS WILL BE USED IN THE CONTEXT OF THIS PROGRAM. IT'S ALSO IMPORTANT FOR THIS PROGRAM TO INFORM PATIENT ENGAGEMENT STRATEGIES SPECIFIC TO CANCER SEQUENCING EFFORTS AND WHETHER WE WILL ACHIEVE A GREATER TIE VERSE IT OF PATIENTS AND CANCER TYPES. THE SCIENTIFIC METRICS WILL INCLUDE OUR ABILITY TO PERFORM GENOMIC CHARACTERIZATION USING THE PATIENT ENGAGEMENT APPROACH AND WHETHER WE HAVE ADDRESSED RESEARCH GAPS. SO I SPOKE TO YOU ABOUT DEMONSTRATION PROJECT, THE PATIENT ENGAGEMENT FOR PRIORITY CANCER SEQUENCING, ILLUSTRATING HOW WE USE PATIENT ENGAGEMENT FOR DISCOVERY SCIENCE WEE. BE ABLE TO LEVERAGE SOME OF THE THE LESSONS LEARNED IN THE FUNDAMENTAL RESEARCH PROGRAM, PARTICULARLY -- TO HELP US THINK ABOUT HOW WE ENGAGE UNDERSTUDIED POPULATIONS. THE DEMONSTRATION PROJECTS WILL ALSO BE ABLE TO INFORM THE NCI PATIENT PORTAL DESIGNED THAT YOU'LL HEAR ABOUT NEXT AND ALSO BE ABLE TO USE THE NCI DEVELOP PORTAL AS AN ADDITIONAL METHOD TO ENGAGE AND COMMUNICATE WITH PATIENTS. FINALLY WE HAVE A COORDINATING CENTER WHICH IS GOING TO SERVE AS A CLEARINGHOUSE OF BEST PRACTICES OF HOW TO ENGAGE WITH PATIENTS AND THAT WILL REALLY HELP OUR UO1s TRY TO BE ADAPTIVE AND USE THE BEST STRATEGIES. THE U01 PROJECTS WE'RE PROPOSING MUST WORK WITH THE COORDINATING CENTER AND THE FUNDAMENTAL RESEARCH PROGRAM TO DEVELOP BEST PRACTICES FOR PATIENT ENGAGEMENT AND DISSEMINATE AT THE END OF THIS INITIATIVE AND ALSO A PLAN FOR SUSTAINABILITY OF THE NETWORK. SO I WANTED TO THANK OUR SUBCOMMITTEE FOR THEIR FEED BACK, JIM, ELANA, MARY LEW. THE FIRST FOUR BULLETS ON THE SLIDE, I'VE ALREADY ADDRESSED IN THE CONTEXT OF THE PRESENTATION BUT HAPPY TO DISCUSS MORE. THE LAST -- THE SECOND TO LAST BULLET WAS ABOUT CONSIDERATIONS OF PEER REVIEW THAT WILL BE REALLY CRITICAL TO IDENTIFY APPROPRIATE REVIEWERS FOR THIS INITIATIVE GIVEN THE MULTIDISCIPLINARY NATURE OF IT. WE WILL WORK VERY CLOSELY WITH THE DIVISION OF EXTRAMURAL ACTIVITIES TO MAKE SURE WE HAVE APPROPRIATE EXPERTISE. THE LAST BULLET WAS THE CONSIDERATION OF THIS IN THE CONTEXT OF OTHER CLINICAL SEQUENCING OR OTHER ONGOING RESEARCH SEQUENCING EFFORTS, AND I'LL TALK ABOUT THIS ON THE NEXT SLIDE. SO IT'S IMPORTANT TO NOTE THAT CLINICAL CARE IS ALWAYS THE FIRST PRIORITY, WE WILL NOT COMPETE WITH CLINICAL CARE IN IN INITIATIVE. OUR PROGRAM IS DESIGNED TO HAVE A MORE NARROW FOCUS TO REALLY BE ENRICHED FOR THOSE RARE CANCER SUBSETS OR UNDERSTUDIED POPULATIONS THAT ARE CURRENTLY NOT WELL CAPTURED AND OUR PROGRAM IS REALLY DESIGNED TO BE FOCUSED ON DISCOVERY RESEARCH TO GENERATE MORE COMPREHENSIVE CHARACTERIZATION OF TUMORS IN SOME OTHER INITIATIVES. WE PLAN TO COLLECT RICH EPIDEMIOLOGY IN CLINICAL DATA TO ENRICH THE VALUE OF GENOMIC DATA. I'VE ALREADY TALKED ABOUT THESE TWO BULLETS BUT JUST TO SUMMARIZE, THIS IS REALLY A FOCUSED EFFORT DESIGNED TO COMPLEMENT EXISTING EFFORTS AND INFORM FUTURE NCI INITIATIVES. SO I WANTED TO PUT THIS IN THE CONTEXT OF NCI GRANT PORTFOLIO. THERE ARE A LARGE NUMBER OF GRANTS AND PROJECTS THAT CURRENTLY SUPPORT TUMOR EXEENS SCWEENSING BUT THESE DO NOT USE DIRECT PATIENT ENGAGEMENT STRATEGY AND RESEARCH GAPS IN OUR SEQUENCING REMAIN. AS DEBBIE ALREADY MENTIONED, THERE ARE A LARGE NUMBER OF INITIATIVES THAT HAVE BEEN USING PATIENT ENGAGEMENT IN DIFFERENT CONTEXTS BUT ONLY ONE NCI GRANT IS FOCUSED ON DIRECT PATIENT ENGAGEMENT TO INCREASE PARTICIPATION IN DISCOVERY RESEARCH. THIS DOES NOT INCLUDE TUMOR MOLECULAR CHARACTERIZATION. SO WE'RE ASKING FOR FUNDING FOR FOUR UO1 AWARDS, 600 THOWDZ TOTAL COST EACH FOR A TOTAL OF $12 MILLION. WE'LL ALSO BE PROVIDING FUNDS TO THE NCI CENTER CANCER GENOMICS PIPELINE OF $6 MILLION FOR A TOTAL OF 28 MILL YONDZ. SO TO SUMMARIZE, THIS PROGRAM WILL PROVIDE INSIGHTS TO DEVELOPMENT AND SUSTAINABILITY OF A LARGER NETWORK FOR DIRECT PATIENT ENGAGEMENT. IT WILL ENGAGE PATIENTS AS PART OF THE RESEARCH ENTERPRISE, AND IT WILL ADDRESS GAPS IN THE UNDERSTANDING OF OUR GENOMICS PROFILE OF PATIENTS WITH RARE CANCERS, CANCER SUBTYPES AND CANCER IN UNDERSTUDIED POP LAYINGS AND ALSO FOR THE BROAD RESEARCH COMMUNITY. I THANK YOU AND I'M HAPPY TO TAKE ANY QUESTIONS. >> THANKS SO MUCH, LEAH. APPRECIATE THE PRESENTATION. WE HAD A SUBCOMMITTEE CONSISTING OF JIM, ELANA AND MAYOR EYE LOU, WHO IS NOT HERE TODAY. I'LL TURN TO JIM. >> THANK YOU FOR A NICE PROPOSAL AND NICE PRESENTATION. SOME OF THE THEMES HAVE ALREADY BEEN ADDRESSED TODAY. YOU TOUCHED ON OR YOU SUMMARIZED NICELY THE ISSUES WE RAISED DURING OUR CALL WITH YOU, WHICH WAS THOROUGH. IF IT'S OKAY WITH THE GROUP, I'D LIKE TO PUNT A LITTLE BIT ON THAT FIRST ISSUE OF DEFINING AND MEASURING PATIENT ENGAGEMENT. WE'VE TALKED ABOUT THAT. IT'S GOING TO BE AN ISSUE. WE MENTIONED THAT -- YOU MENTIONED TO US THE TRANS-NIH PATIENT ENGAGEMENT OR IS IT TRANSNCI, DEBBIE, PATIENT ENGAGEMENT GROUP AND I THINK COORDINATION WITH THAT GROUP WOULD BE ESSENTIAL FOR DEFINING THIS. THE KEY TEAM THAT I WANT TO MENTION THAT HASN'T COME UP SO MUCH BUT I THINK IT INTERSECTS NICELY WITH WHAT WE JUST TALKED ABOUT IS PEER REVIEW. THE CHALLENGE OF PEER REVIEW CAME UP YESTERDAY IN GENERAL TERMS AND I THINK FOR THIS RFA, IT'S GOING TO COME UP IN SPECIFIC TERMS, AND YOU'VE DEFINED A BROADEN GAUGEMENT SPECTRUM. THE MORE YOU CAN CLEARLY ARTICULATE AND PROBABLY POINT BACK TO THAT VERY NICE SLIDE THAT DEBBIE PRESENTED ON BARRIERS, AND MAKE SOME DECISIONS, WHICH OF THOSE BARRIERS DO YOU WANT APPLICANTS TO ADDRESS, DO YOU WANT THEM TO ADDRESS ALL, AND IN DOING SO, I THINK YOU'LL OUTLINE WHAT KIND OF REQUIREMENT IS NEEDED FOR PEOPLE TO ADEQUATELY REVIEW THESE APPLICATIONS AND TO INFER APPLICANTS TO PROPOSE WHAT THEY'RE GOING TO DO. THE OTHER KEY THEME THAT I HOPE THE GROUP WILL BRING SOME COMMENTS ON THIS MORNING IS THE FOCUS ON SEQUENCING RACE AS THE ISSUE OF THESE ARE LIKELY GOING TO BE HIGH PRIORITY PATIENTS AND THEY'LL PROBABLY BE TARGETED FORECLINICAL AND RESEARCH SEQUENCING EFFORTS. IT'S VERY REASSURING TO HEAR THAT YOU WILL PRIORITIZE THE CLINICAL SEQUENCING NEEDS BUT I THINK AT THE POINT OF THEN THE AWARDS BEING ADMINISTERED, THAT'S GOING TO BE A SIGNIFICANT CHALLENGE OF MANAGING THOSE COMPETING PRIORITIES. OVERALL A VERY HIGH LEVEL OF ENTHUSIASM, WE HEARD THROUGH THE PRESENTATION, THROUGH YOUR COMMENTS, THAT THERE'S A DEEP UNDERSTANDING OF HOW IMPORTANT THIS CHALLENGE IS, BUT ALSO I THINK THAT THIS IS AN IMPORTANT STEP IN ADDRESSING IT. ELANA, ANY OTHER COMMENTS TO ADD FROM OUR DISCUSSION? >> NO MORE COMMENTS. I ALREADY COMMENTED ON THE PRIOR ONE. I DO WANT TO COMMEND YOU FOR REALLY HIGHLIGHTING THE IMPORTANCE AND ON UNDERSTUDIED POPULATIONS. THAT'S REALLY, REALLY IMPORTANT. >> DR. LOWY. >> SO I THINK THIS IS REALLY AN IMPORTANT PROJECT TO INCREASE MINORITY REPRESENTATION IN OUR GENOMIC DATABASES, BUT LIVING THIS EVERY DAY AND ACTUALLY TRYING TO IMPLEMENT THE EARLY ONSET MALIGNANCIES INITIATIVE THROUGH NCOR AND THE ORION PROJECT IN HISPANIC AND AMERICAN INDIAN POPULATIONS, I'M GOING TO TELL YOU WHAT THE PROBLEM IS. THE MAJOR REASON TO REFUSE CONSENT IS THE DATA DOESN'T COME BACK TO THE PATIENT, EVEN IF IT'S RESEARCH-GRADE DATA. THEY'RE LIKE, WHAT'S THE END POINT, WHO'S USING MY DATA AND WHY? IF THE SAMPLE GOES TO THE NCI, THEN WHAT HAPPENS TO IT? I LOSE CONTROL. WE HAVE VERY DEEP DATA ON ABOUT 1400 PATIENTS THAT COULD GIVE YOU THOSE RESULTS TODAY. SO WE SIT BACK WITH AN ETHICAL PROBLEM IN MY INSTITUTION ABOUT DO I KEEP DOING STUDIES LIKE TO TRY TO OVE RCOME THOSE ISSUES OR DO I TRY TO COME AT IT IN A DIFFERENT WAY. SO AGAIN I WONDER IF YOU LOOK AT THE EARLY ONSET MALIGNANCIES PROJECT, IT HASN'T BEEN SUCCESSFUL. THE ACCRUAL TO THAT HAS BEEN LIKE SUPER LOW AND I THINK WE SHOULD SIT HERE AND TALK ABOUT WHY IT IS. AND IT'S ALL KINDS OF ISSUES. SO ABSOLUTELY THE GOAL OF GETTING SEQUENCING DONE ON THESE MINORITY POPULATIONS IS HUGELY IMPORTANT, BUT THERE NEEDS TO BE A REAL END POINT. SO I WOULD WANT TO YOU GO BACK AND THINK ABOUT COULD YOU DO CLIA PANEL SEQUENCING IN THESE PATIENTS, WHICH CERTAINLY THE NCI COULD DO, WHILE YOU'RE DOING THE BROADER RESEARCH STUDY TO HAVE SOMETHING TO RETURN. BECAUSE THAT WOULD MAKE PEOPLE ACTUALLY BE WILLING TO ACCRUE AND COULD YOU NOT KEEP CUTTING THE CANCER CENTERS OUT OF THE MIDDLE WHERE ALL THE DATA GOES TO THE NCI AND SOMEDAY WE GET IT BACK, BUT YOU ACTUALLY DO THIS IN COLLABORATION WHERE THAT DATA COMES BACK IN REALTIME FOR SHARED PURPOSES, SO IT ACTUALLY CAN EFFECT PATIENT OUTCOME. IN THE NCOR EARLY ONSET MALIGNANCIES INITIATIVE, THE PROBLEM WAS THERE WASN'T ENOUGH TISH TEU TISSUE. SO I DON'T WANT TO DENY THE PERSON THE ABILITY TO GET CLI CLIA -- WHILE I DO WANT TO DO THE MORE COMPREHENSIVE RISK STUDY. SO THINKING ABOUT THAT APPROACH, I KNOW IN THE EXPERIENCES WE'VE LIVED, THESE ARE THE DIFFICULTIES WE'RE EXPERIENCING IN NCOR, IN OWE OH ORION. THE SENSE YOU'RE GOING TO EXPERIMENT ON ME WITHOUT GIVING ME SOMETHING BACK IS A HUGE BARRIER IN MINORITY POPULATIONS. THINK WE CAN WORK WITH THE NCI, TALK WITH DR. LOWY, ABOUT THAT OTHER ISSUE OF CAN YOU PROTECT MY INDIVIDUAL IDENTITY IN THESE DATABASES? THAT CAN BE OVERCOME. AND I THINK THESE MORE FUNDAMENTAL ISSUES ABOUT WHAT DO I GET OUT OF PARTICIPATING IN SUCH A STUDY MEAN IS A HUGE ISSUE IN MINORITY POPULATIONS. >> YOU'RE GETTING NODDING HEADS AROUND THE TABLE. GO AHEAD. >> I JUST WANTED TO FOLLOW UP ON THAT VERY INTERESTING DISCUSSION. SO IN OUR CANCER CENTER, WE ACTUALLY SET UP A CLIA LAB IN THE SEQUENCING LABS TO BE ABLE TO ACTUALLY DO BOTH, TO BE ABLE TO GET MORE IN DEPTH SEQUENCING THAN THE STANDARD TEST BUT BE ABLE TO GIVE THE INFORMATION BACK TO PATIENTS. THE QUESTION IS HOW MANY OTHER CANCER CENTERS ACTUALLY HAVE DONE THAT, AND IS THAT GOING TO BE SOMETHING IN THE FUTURE THAT WE'RE GOING TO SEE MORE AND MORE, PARTICULARLY IN CANCER CENTERS THAT WANT TO GENERATE NEW KIND OF INFORMATION THAT GO BEYOND PANEL TESTING, IS IT GOING TO BE VERY WORTHWHILE. IT ACTUALLY IS NOT THAT HARD OR EXPENSIVE TO SET IT UP, BUT YOU HAVE TO HAVE THE WILL TO DO IT. >> THANKS FOR THE COMMENT. >> THERE ARE A COUPLE OF THINGS THAT CONCERN ME ABOUT THIS. ONE IS, IT'S NOT CLEAR IF YOU'RE DOING A PROSPECTIVE STUDY WHERE YOU'RE ENROLLING, SEQUENCING, POSSIBLY RETURNING RESULTS, WHICH WILL TAKE A LONG TIME TO DO, PESHESLY FOR THESE RARE TUMORS TO IDENTIFY PEOPLE, OR WHETHER THE REAL GOAL IS TO REALLY UNDERSTAND THE TUMORS, IN WHICH CASE YOU'D BE BETTER OFF USING ALREADY CONSENTED SAMPLES FOR SEQUENCING WHERE RETURN OF RESULTS IS NOT AN ISSUE. SO THOSE ARE TWO COMPLETELY DIFFERENT WAYS TO DO THE STUDY. IT SOUNDS LIKE SOME KIND OF A HYBRID APPROACH WHERE YOU'RE GOING TO BE DOING SOME PROSPECTIVE SEQUENCING, RETURN OF RESULTS, ET CETERA, AND SOME THAT IS DONE WITH BANKED SAMPLES. IT WOULD GO A LOT FASTER IF YOU USE BANKED SAMPLES. >> SO TO CLARIFY -- SORRY I HAVEN'T ADDRESSED THE OTHER QUESTIONS BUT TO CLARIFY, IT WILL ACQUIRE SAMPLES THAT ARE ALREADY EXISTING SO WE'LL GET PERMISSION TO REQUEST THOSE SAMPLES. WE'RE REQUIRING THE U01 SITES TO GET GERMLINE GENETIC SAMPLES, SO IT IS SOMEWHAT OF A HYBRID MODEL. >> THAT COULD BE A PROBLEM BECAUSE THE WAY YOU HANDLE THOSE KINDS OF DATA ARE COMPLETELY DIFFERENT. THE PROSPECTIVE SEQUENCING, I AGREE WITH WHAT MAX AND CHERYL HAVE SAID. FOR THE ALL-OF-US PROPOSAL THAT'S OUT FOR RFA RIGHT NOW, IT'S ALL FOR WHOLE GENOME SEQUENCING WITH THE CARROT OF YOU'RE GOING TO RETURN ACTIONABLE SEQUENCING THAT'S DONE IN THE GERMLINE. IT'S ALL BEING DONE IN THE CLIA SETTING. SO IF YOU ARE GOING TO USE PROSPECTIVE BANKING, I AGREE THERE SHOULD BE THIS CARROT OF RETURN OF RESULTS, DOING EXOMES IN A CLIA LAB IS REALLY NOT THAT BIG OF A PROBLEM, IT'S NOT TERRIBLY EXPENSIVE. AND RETURN OF RESULTS COULD BE CONSIDERED. I THINK YOU HAVE TO THINK ABOUT TAILORING THIS PROPOSAL MORE NARROWLY. IT'S EITHER BANKED SAMPLES WHERE YOU'RE LEARNING ABOUT RARE TUMORS IN RARE POPULATION WHICH COULD GO QUITE QUICKLY IF YOU IDENTIFY THE RIGHT SOURCES, OR THE OTHER ISSUE BEING A PROSPECTIVE STUDY WITH RETURN OF RESULTS, THEY'RE REALLY QUITE DIFFERENT ISSUES IN TERMS OF HOW THE DATA WILL BE HANDLED. >> AND I MIGHT HAVE MISSPOKE TOO, BECAUSE I GUESS WE'RE NOT NECESSARILY -- WE THINK THERE'S MANY DESIGNS THAT THE UO1s CAN PROPOSE OF HOW THEY'RE GOING TO GET THE SAMPLES AND WE HAVEN'T BEENDESCRIPTIVE, BUT WE ARE RECRUITING THE PATIENTS PROSPECTIVELY BUT THEY MAY HAVE SOME SAMPLES THAT ARE BANKED THAT WE OBTAIN ACCESS TO AND APPROVAL FOR. SO I'M SORRY THAT I MADE THAT UNCLEAR. >> IF YOU'RE GOING TO DO THAT, THOUGH, THE RIGHT THING DO RIGHT NOW IS TO DO IT IN A CLIA LAB, CLEE WRA EXOME, AND RETURN RESULTS SO THAT CARROT REALLY EXISTS FOR THESE PATIENTS. I JUST THINK THE FIELD HAS MOVED ENOUGH IN THE LAST YEAR OR SO THAT THAT'S SORT OF BECOMING THE STANDARD OF EXPECTATIONS THAT PATIENTS PARTICIPATING IN THESE PROTOCOLS HAVE. >> ONE THOUGHT THAT WE HAVE IN THE INITIATIVE IS THAT THIS IS REALLY SORT OF A FIRST STEP THAT WE WANT THE U01s TO EXPLORE HOW TO DO THAT, BUT WE THOUGHT THAT AT LEAST IN A CONTEXT OF THE FIRST STEP THAT THAT MAY NOT BE AFFORDABLE OR POSSIBLE TO BE DONE, BUT THIS IS DEFINITELY -- WE CAN EXPLORE AND WE'VE THOUGHT ABOUT DOING A LOT OF THAT FOLLOW-UP CLIA TESTING TO REPORT BACK. >> I'D THINK ABOUT DOING IT RIGHT THE FIRST TIME. >> OKAY. THAT'S GOING TO MAKE -- >> NOT TO PRECLUDE DISCUSSION AND NOT TO TELL YOU GUYS TO DO OR WHAT NOT TO DO, BUT I WILL SAY STATEMENT THAT THESE SAMPLES EXIST IN FREEZERS AND ARE READY TO GO, I DON'T THINK IS TRUE. SO IF YOU WANT TO GET CERTAIN RARE MALIGNANCIES THIS IS WHERE JAK2 CAME FROM, GARY GOT EVERYBODY TO MAIL IN THEIR SAMPLES. THIS WORKS AND THIS IS THE ANGIOSARC PROGRAM THAT GOING ON AT THE FARBER NOW, SO THIS MIGHT BE A WAY TO GET ACCESS TO VERY RARE CANCERS WITH SOME CLINICAL ANNOTATION THAT WOULD BE HARD TO COME BY THROUGH OTHER MEANS. I DON'T THINK THEY'RE SITTING IN SOMEONE'S FREEZE ARE THAT THEY'LL EASILY COUGH UP TO THE NCI. WE'VE TRIED THAT, THAT'S BEEN GOING ON THROUGH THE RARE TUMOR PROGRAM ALREADY. SO I THINK THIS FRAMEWORK COULD BE VALUABLE FOR A SPECIFIC QUESTION. NOW IF YOU WANT TO BUILD IT INTO ANOTHER THING THAT'S ABOUT RECRUITING SPECIFIC POPULATIONS, RETURN OF RESULTS, IT'S A DIFFERENT THING. MAYBE WE SLU BE DOING THAT, THAT WOULD PROBABLY REQUIRE A DIFFERENT STRUCTURE AND BUDGET. THAT'S WHAT I THINK THIS COMMITTEE SHOULD BE DISCUSSING. >> I THINK WITH THAT, WE'LL TAKE A MOTION UNLESS YOU WANTED TO DISCUSS -- I'LL TURN TO JIM, OR KAREN. >> THIS IS REALLY A CROSS CUTTING COMMENT BUT IT DOES RELATE TO THIS ISSUE. I'M A LITTLE -- I THINK THIS WHOLE GROUP OF PROPOSALS IS REALLY INTERESTING AND I THINK IT WILL SHAPE UP REALLY WELL AND HELP THE FIELD ALO. I'M A LITTLE CONFUSED WHEN I TRY TO MAKE SENSE OF THE BUDGET NUMBERS. SO THE COMMUNICATION, WENDY'S PROPOSAL IS A MILLION DOLLARS A YEAR PER SITE, THE ONE THAT DEPEE PRESENTED IS $500,000 PER YEAR PER SITE AND THIS IS 600,000? I DON'T UNDERSTAND SORT OF THE MAP, BECAUSE IT SEEMS TO ME LIKE MANY OF THEM ARE ASKING A LOT OF THESE CENTERS. SO AS THESE ARE PRESENTED, IF ANY OF THEM COME BACK, YOU'LL IT WILL BE SUPER HELPFUL TO THE BOARD TO UNDERSTAND A LITTLE MORE CLEARLY WHAT'S BEING ASKED OF THE INVESTIGATORS AND WHY THE BUDGETS HAVE BEEN SET AS THEY ARE BECAUSE SOME OF THEM HAVE BEEN WRITTEN SO BROADLY THAT THERE'S AN AWFUL LOT HERE AND I THINK IT'S GOING TO AFFECT THE POOL OF PROPOSALS THAT YOU GET. >> OKAY. I THINK WITH THAT, WE NEED TO MOVE TO A MOTION. >> MAY I ASK A QUESTION GIVEN HE THE RELATEDNESS OF THIS QUESTION TO THE LAST ONE? IF THIS CONCEPT WOULD BE APPROVED, WOULD THERE BE DISCRETION AT THE PROGRAM OR INSTITUTE LEVEL TO COORDINATE IT WITH, FOR FOR EXAMPLE, THE DEFERRED PROPOSAL BEFORE IN TERMS OF TIMING AND SPECIFICS, THINGS LIKE THAT? >> [INAUDIBLE] >> SO BASED ON THAT, I'LL MAKE A MOTION HEARING ALL OF THE PRODUCTIVE COMMENTS AND SUGGESTION TO APPROVE THIS. >> SECOND? ANYBODY SECOND? OKAY. DISCUSSION? OKAY. >> ONE POINT. THE OTHER ISSUE THAT HE WE DIDN'T TALK SO MUCH ABOUT WERE THE METRICS. YOU LISTED THEM NICELY ON YOUR SLIDE. I THINK THAT INTERSECTION OF CLINICAL, YOU KNOW, CLIA TESTING VERSUS RESEARCH, IT MAY BE THAT IN THE SPIRIT OF THE MOONSHOT, BY THE TIME THIS WOULD GO OUT IN THREE, FOUR YEARS, THE NORM HAS BECOME RETURN RESULTS IN CLIA LABS, THE ONLY PLACE YOU'RE GOING TO GET THOSE METRICS IS IN THAT SETTING SO I'D ENCOURAGE YOU TO LOOK CLOSEL AT THAT AS WELL. >> THANK YOU. >> GO AHEAD. >> CAN I DISCUSS NOW OR DO WE HAVE -- WE HAVE SECOND? OKAY. THANK YOU. I GUESS MY FEELING IS BASED ON THE DISCUSSION WE JUST WHY WOULD YOU NOT RECOMMEND TO DEFER THIS ALONG WITH THE OTHER CONCEPT AND HAVE THEM BOTH COME BACK BETTER ALIGNED? >> IT'S A GOOD QUESTION SIMPLY FROM THE STARTING POINT OF IF THE GROUP PREFERS DEFER, THEN THEY CAN DISAGREE WITH THE VOTE TO APPROVE. I WOULDN'T TAKE OFFENSE TO THAT. TO ME, IT OPENED UP THE POBT FOR BOTH RATHER THAN STARTING FROM THE STANDPOINT OF DEFERRAL. BUT I COMPLETELY AGREE WITH THE SPIRIT OF YOUR QUESTION, I THINK IT'S A GOOD ONE. >> WHEN WE VOTE, WE VOTE EITHER TO APPROVE, DISAPPROVE OR DEFER, THAT WILL BE OUR VOTE. SO IT'S WITHIN THE SCOPE OF OUR VOTE. IS THERE ANY FURTHER COMMENT OR DISCUSSION? OKAY. SO ALL IN FAVOR TO APPROVE? ALL TO DISAPPROVE? ALL TO DEFER? WE'LL TAKE A VOTE. NOW YOU CAN GO. >> THANK YOU. >> THANK YOU VERY MUCH. >> SO THE NEXT AND FINAL PRESENTATION IS PORTAL TO SUPPORT PATIENT ENGAGEMENT PROJECT, AND THIS PORTAL IS TO SUPPORT THE LAST TWO CONCEPTS THAT WERE JUST DISCUSSED. BUT SINCE THIS CONCEPT IS GOING TO BE SUPPORTED BY LIDOS CONTRACT AND NOT A GRANT, A COOPERATIVE AGREEMENT OR RESEARCH AND DEVELOPMENT CONTRACT, IT'S BEING PRESENTED AS INFORMATION ONLY. SO WE WILL NOT BE VOTING ON THIS PARTICULAR PROPOSAL. AND DR. HANNAH DUECK WILL PRESENT. HANNAH? >> I'M HANNAH DUECK AND IEBL PRESENTING ON A PORTAL TO SUPPORT PATIENT ENGAGEMENTS ALONG WITH DR. HSU. THIS IS PART OF THE PATIENT ENGAGEMENT FOR DISCOVERY SCIENCE RESEARCH PROGRAM. AND THE VISION OF THIS PROJECT IS TO DEVELOP A PORTAL AND RELATED TOOLS TO SUPPORT NCI PROJECTS THAT DIRECTLY ENGAGE INDIVIDUALS AS A PART OF THEIR RESEARCH DESIGN. THE BLUE RIBBON PANEL RECOMMENDED A PORTAL UNDER BOTH THE ENHANCED DATA SHARING WORKING GROUP AND NETWORK FOR DIRECT PATIENT ENGAGEMENT. THE RECOMMENDATIONS IMAGINED A WEB PORTAL THAT WOULD ALLOW INDIVIDUALS TO SHARE THEIR HEALTH DATA FOR SCIENTIFIC RESEARCH. IN THE CONTEXT OF DIRECT PATIENT ENGAGEMENT FOR DISCOVERY RESEARCH, A PORTAL IS ESSENTIALLY A WEBSITE THAT ALLOWS A PROJECT TEAM TO INTERACT DIRECTLY AND VIRTUALLY WITH INDIVIDUAL PARTICIPANTS. THE TYPES OF -- AND INFORMATION EXCHANGE AND RETURN OF INFORMATION. BECAUSE THE LANGUAGE CAN GET CONFUSING IN THIS PRESENTATION I'LL REFER TO THIS TYPE OF WEBSITE AS A PORTAL AND I'LL REFER TO THIS PROJECT AS THE NIH CANCER.GOV OR THE PEARL PROJECT FOR SHORT. THE INTENTS OF THIS PROJECT IS TO SUPPORT NIH EFFORTS THAT REQUIRE A PORTAL AS ONE PIECE OF A LARGER ENGAGEMENT RESEARCH DESIGN. THERE ARE A COUPLE OF PROJECT THAT'S FALL INTO THIS CATEGORY. AND YOU JUST HEARD TWO OF THE PROPOSALS. THE CANCER MOON SHOOT BIOBANK WAS FUNDED IN FISCAL YEAR '16. FOR THIS PROJECT A PORTAL WILL HELP SUPPORT ONGOING INTERACTIONS BETWEEN A PROJECT TEAM AND THE INDIVIDUAL PARTICIPANTS AND PARTICULAR ATTENTION TO THE PARTICIPANTS ON THIS STUDY. THE MOON SHOT FUNDED THE RARE TOMB ARPATIENT ENGAGEMENT NETWORK IN FISCAL YEAR '18. THIS PROJECT AIMS. THESE PATIENTS WILL USE A PORTAL TO SELF-REPORT THEIR DATA OTHER TO RECEIVE RECOMMENDATIONS FOR RELEVANT CLINICAL TRIALS. BOTH IN ADULT AND PEDIATRIC POPULATION ARE INVOLVED IN THE STUDY. AND AS YOU'VE HEARD WE EXPECT MORE ENGAGEMENT PROJECTS IN THE FUTURE SUCH AS THE PROJECTS YOU JUST HEARD ABOUT. THIS PROJECT WILL SUPPORT EXISTING AND FUTURE NIH ENGAGEMENT EFFORT IN TWO KEY WAYS. FIRST IT WILL REDUCE DEVELOPMENT TIME AND COST FOR INDIVIDUAL ENGAGEMENTS PROJECTS. AND ALSO BY LEVERAGING NIH'S EXISTING DIGITAL RESOURCES BY THE PUBLIC INCLUDING CANCER.GOV. THIS PROJECT WILL SUPPORT AN INTEGRATED AND USER-FRIENDLY EXPERIENCE. THE GOAL IS TO DEVELOP A SYSTEM THAT IS RESPECTFUL OF PARTICIPATE TIME. BY AVOIDING THE NEED FOR PARTICIPANTS TO PARTICIPATE IN MULTIPLE PROJECTS AND BY MAKING SURE THAT INDIVIDUALS HEAR ABOUT ABOUT THEIR CONTINUESES TO RESEARCH. THE ULTIMATE VISION FOR THIS PROJECT INCLUDES TWO KEY PIECES. FIRST THE PATIENT GATEWAY WILL BE A SINGLE POINT OF ENTRY. THIS IS ESSENTIALLY A WEBSITE WHERE AN INDIVIDUAL CAN GO TO ENGAGE ANY PROJECT. GO TO THE SITE AND CLICK ON A LINK AND GO TO A SPECIFIC STUDY PORTAL. SECOND, THE MODULAR COMPONENTS WILL BE USED TO EFFICIENTLY LAUNCH A SPECIFIC STUDY FOR TO THE. -- PORTAL. FIRST THE PATIENT GATEWAY. BY PROVIDING ACCESS TO ALL NIH ENGAGEMENT PROJECTS IT WILL AMPLIFY AT EACH OF THE PROJECTS. IT WILL BE HOSTED ON CANCER.GOV THAT PROVIDES A WEALTH OF INFORMATION FOR CANCER POKERS AND HEALTH CARE PROVIDERS. AND ALSO BY NCI CONTACT CENTER. THE GATEWAY WILL ALSO PROVIDE A SET OF GLOBAL SERVICES. THIS SET OF SERVICES WILL INCLUDE THE ABILITY TO SEARCH AND FILTER ACROSS INDIVIDUAL STUDIES SO THAT PATIENTS CAN FIND RELEVANT PROJECTS. REDUCING THE NEED FOR DATA REENTRY AND ALSO SUPPORT THE ABILITY OF PROJECT TEAMS TO RECONTACT AND RETURN INFORMATION TO PARTICIPANTS AND PROVIDING GENERAL INFORMATION TO PARTICIPANTS INCLUDING LAY SUMMARIES OF STUDY RESOURCES AND LINK TO RESOURCES ON CANCER.GOV AND THE CENTER. WHILE THE PATIENT GATEWAY PROVIDES ACCESS TO ALL PROJECTS THE INTENT OF THE MODULAR COMPONENT IS TO SUPPORT SPECIFIC PROJECTS. THE SET OF COMPONENTS WILL INCLUDE CUSTOMIZABLE MODULES. TO ILLUSTRATE WE'LL IMAGINE THAT WE'RE LAUNCHING A PORTAL FOR A NEW ENGAGEMENT PROJECT. WE MAY NEED TO CONSENT PATIENTS AND ALLOW THEM TO -- DATA OVER TIME -- RECOMMEND RELEVANT CLINICAL TRIALS AND COMMUNICATE DIRECTLY WITH PARTICIPANTS. THIS INITIAL SET OF MODULES WAS BASED ON THE NEEDS OF THE EXISTING EFFORTS WHICH WERE THE EARLY ADOPTERS. EACH WILL BE STAND ALONE AND CUSTOMIZABLE. THE INTENT IS THAT THESE COMPONENTS CAN BE EASILY ADAPTED FOR RESEARCH DESIGNS. FINALLY THE MODULAR COMPONENTS WILL BE INTEGRATED WITH COMPLIMENTARY EFFORTS. THIS PROJECT WILL BE DEVELOPED IN A TWO PHASE PROCESS AND CURRENTLY PHASE I HAS BEEN APPROVED. THE GOALS ARE TO GENERATE RECOMMENDATIONS FOR HOW TO DEVELOP THE PROPONENTS AND TO LAUNCH THE PATIENT GATEWAY. THE FIRST SIX MONTHS OF THE PROJECT WILL INCLUDE A LANDSCAPE ANALYSIS AND NEEDS ASSESSMENT. THIS WILL INVOLVE A COMPREHENSIVE SURVEY. IT WILL ALSO INCLUDE INPUT TO IDENTIFY THE NEEDS AND PREFERENCES OF THESE DIVERSE POPULATIONS. IN COLLABORATION WITH THE NCI CENTER AND THE OFFICE OF ADVOCACY REALIZES. THE NEEDS ASSESSMENT WILL BE FOLLOWED BY A COMPLETE AND ENVIRONMENTAL SCAN. THIS ANALYSIS WILL BE USED TO DEVELOP A SET OF RECOMMENDATIONS FOR HOW TO DEVELOP THE MODULAR COMPONENTS. THE RECOMMENDS WILL ALSO INCLUDE A PLAN FOR HOW TO INTEGRATE MATERIALS. AND A PLAN TO INCORPORATE BEST PRACTICES. THE RECOMMENDATIONS WILL BE PRESENTED TO NC BE I FOR REVIEW. FINALLY THE FIRST PHASE OF THE PROJECT WILL INCLUDE INITIAL DEVELOPMENT OF THE PATIENT GATEWAY. THE STUDY SPECIFIC PORTALS WILL BE INCORPORATED INTO THE PATIENT GATEWAY. I WANTED TO HIGHLIGHT ALL ACTIVITY THAT'S WILL BE IN COLLABORATION. THIS OFFICE BRINGS EXPERTISE. ALL ACTIVITIES WILL ALSO BE DONE IN COLLABORATION WITH AN INTERNAL ADVISORY TEAM AND WILL INCLUDE REPRESENTATIVES FROM ACROSS NCI. THIS TEAM WILL PROVIDE EXPERTISE AND MAKE SURE THAT RELEVANT NCI RESOURCES ARE LEVERAGED WHERE EVER POSSIBLE. THE RECOMMENDATIONS DEVELOPED DURING THE FIRST PHASE OF THE PROJECT WILL INFORM THE SECOND PHASE AND PRIMARILY DEVELOPING THE MODULAR COMPONENTS. ALSO EXTENDING THE PATIENT GATEWAY TO MEET NEWLY IDENTIFIED NEEDS, CONTINUE DEVELOPED BASED ON FEEDBACK. DEVELOPING A MECHANISM FOR PROJECT TEAMS TO CONTRIBUTE ADDITIONAL MODULAR COMPONENTS. PARTNERSHIPS ARE CRITICAL AND THERE ARE A VARIETY OF EXTERNAL RESOURCES. THE LANDSCAPE ANALYSIS IN PHASE I WILL SURVEY BOTH INTERNAL AND EXTERNAL RESOURCES TO DETERMINE THE BEST BENEFITS FOR NCI NEEDS. AND I TALKED ABOUT SEVERAL KEY PARTNERS INCLUDING THE DEPARTMENT OF PUBLIC OFFICE. I ALSO WANTED TO BRIEFLY HIGHLIGHT THE IMPORTANCE. AND ALSO THE OFFICE OF ADVOCACY RELATIONS FOR REACHING KEY STAKEHOLDERS IN THIS PROJECT. IF APPROVED THE FUNDAMENTAL RESEARCH THAT IS PERFORMED BY THE PROJECTS BY DR. WYNN MAY IDENTIFY BETTER PRACTICES AND THOSE WILL BE INCORPORATED INTO THE DESIGN AND THE MODULAR COMPONENTS. THE EXISTING DEMONSTRATION PROJECTS -- PROVIDE THE DRIVING USE CASES FOR THE DEVELOPMENT OF THIS PROJECT. AND IF APPROVED INVESTIGATORS FOR THE SEQUENCING PROJECTS WILL HAVE THE OPPORTUNITY TO USE THE TOOLS AND RESOURCE THAT'S ARE DEVELOPED HERE. AND WITH THAT I WANT TO THANK YOU FOR YOUR ATTENTION AND WE'RE HAPPY TO TAKE ANY QUESTIONS. >> THANK YOU VERY MUCH. ANY QUESTIONS FOR HANNAH? NO. OKAY. THEN ONE MORE POINT. ON THE PRIOR DISCUSSION. -- AND WE'LL TALK TO KAREN -- [ INDISCERNIBLE ] OKAY. AND THEN BEFORE I HAND IT OVER TO LIZ TO FINISH UP THE MEETING I WANTED TO COMMENT QUICKLY -- THIS HAS BEEN REALLY AN INSPIRING AND GRATIFYING EXPERIENCE OVER THE PAST YEARS AND TO SEE UP CLOSE THE DEDICATION OF NCI LEADERSHIP AND STAFF IN SUCH A VIRTUOUS ENDEAVOR IT GIVES ONE FAITH SO THANK YOU VERY MUCH AND WITH THAT I HAND IT OVER TO LIZ. >> I SECOND EVERYTHING THAT ETHAN JUST SAID AND I WANT TO THANK THE BSA FOR A LIVELY DISCUSSION AND I ALSO WANT TO THANK THE NCI STAFF AND LEADERS FOR EVERYTHING THAT THEY ARE DOING AND IT'S AN AMAZING EFFORT AND I HOPE EVERYONE REALIZES HOW MUCH WORK HAS GONE IN TO THIS BY ALL OF THESE WONDERFUL PEOPLE. AND THANK YOU VERY MUCH. AND I JUST WANT TO SAY HAPPY SUMMER AND MEGA JOURNALED.