WELCOME BACK TO THE BSA MEETING AND WELCOME TO STAFF AND PUBLIC. APOLOGIES FOR TAKING AWAY YOUR 10 MINUTES BREAK BUT I WAS TOLD YOU'D GET A BONUS SO NOT TO BE CONCERNED. >> NOT A BONUS. >> IT DOESN'T HAVE TO BE A FINANCIAL BONUS. IT'S 10 MORE MINUTES TOGETHER. >> OKAY. WE'RE ALL ON THE SAME PAGE, NOW. >> TERRIFIC. SO WE HAVE SEVEN CONCEPTS. THREE REISSUES AND TO REMIND EVERYONE IF THE VOTERS AND ISSUANCE. LET'S JUMP RIGHT IN TO THE FIRST CONCEPT IS A REISSUE EARLY DETECTION NETWORK AND WE HAVE A PRESENTATION. SO TO MAKE THIS PRESENTATION DR. CASTLE WILL BE PRESENTING. PHIL. EDRN IS AT THE CORE OF THE PROGRAM AND BIOMARKER DISCOVERY AND EARLY DETECTION. IT'S SHIFT TOWARDS A MORE RIGOROUS APPROACHES WITH MOLECULAR SCIENCES TO IDENTIFY PEOPLE WHO HAVE OR AT RISK OF DEVELOPING CANCER. THE PROGRAM OBJECTIVES. SO SUPPORT AND INVESTIGATORS INITIATED RESEARCH FOR THE DEVELOPMENT AND VALIDATION OF BIOMARKERS FOR EARLY DETECTION PROGRESSION, FOSTERING BETWEEN CLINICAL AND INDUSTRIAL LEADERS AND APPLY BIOMARKER VALIDATION AND CRITERIA AND QUALITY ASSURANCE AND FACILITATE REGULATORY PROCESS TO BRING BIOMARKERS RAPIDLY TO CLINICAL USE AND IT'S AT THE CORE FOR EARLY VALIDATION AND SCREENING AND EARLY DETECTION OF CANCER. HERE'S THE OPERATIONAL AND ORGANIZATIONAL STRUCTURE. PREVIOUSLY, THERE WERE FOUR COMPONENTS WHICH IS THE REFERENCE LABORATORY AND DISCOVERY AND DEVELOPMENTAL LABORATORY AND CLINICAL VALIDATION CENTERS ALONG WITH THE MANAGEMENT AND COORDINATING CENTER. IN THE NEXT PHASE BRL WILL BE COMBINED INTO A BIOMARKER CRITICAL LABORATORY FOR BETTER INTEGRATION. THERE'S A STEERING AND EXECUTIVE COMMITTEE. THERE'S ALSO A NETWORK CONSULTING TEAM WHICH I BELIEVE YOU RECEIVED THEIR REPORT UPON REVIEW OF THE EDRN. THERE ARE FOUR RESEARCH GROUPS, PROSTATE AND OTHER UROLOGIC AND COLON AND OTHER GI. THIS IS THE EXTENT OF COLLABORATIONS AND I SUMMARIZED THIS. THERE'S MANY MORE. IMPORTANTLY, THERE ARE FELLOW PARTNERS INVOLVED PHARMA AND BIO TECH INDUSTRY AND MANY MEMBERS WHO IN THE ACT WITH EDRN PERSONNEL. THE BSA DID A RIGOROUS REVIEW A AND THEY NOTED THE PROGRESS AND PRODUCTIVITY OF THE PROGRAM HAD BEEN SUBSTANTIAL. THEY EMPHASIZED AND RECOMMENDED THE VALIDATION OF TRIALS INCLUDE REPRESENTATION OF DIVERSITY INCLUSION AND IMPLEMENTATION SCIENCE AND ENERGY AND APPLIED A.I. AND MACHINE LEARNING AND EMPHASIZED INCREASING COLLABORATION ACROSS INSTITUTIONS AND BIO TECH COMPANIES NATIONALLY AND INTERNATIONALLY. THERE ARE SOME OF THE QUESTIONS. ONE IS THE RETURN [INDISCERNIBLE] OF SUPPORTED PRODUCTS AND DEVICES THAT HAVE THE GREATEST IMPACT USED IN CLINICAL PRACTICE. ARE THERE ANY OTHER COOPERATIVE GROUPS USING THESE RESOURCES AND PRODUCTS. HOW MANY DEVICES HAVE BEEN DEVELOPED AND NON-DIAGNOSTIC TESTS. DOES THE NCI FUND OTHER MECHANISMS AND PROGRAMS THAT PROMOTE BIOMARKER DEVELOPMENT AND VALIDATION AND TRANSLATION. WHAT ARE THE BEST EXAMPLES HOW THE PROGRAM CHANGED THE PRACTICE OF CLINICAL ONKOL BY OUTCOMES AND -- ONCOLOGY OUTCOMES AND WHAT ARE BEING REVIEWED AND TO BE HIGHLY TRANSFORMATIVE IN THE NEXT FIVE YEARS AND WHAT WOULD BE THE POTENTIAL IMPACT TO KNOW IT'S NO LONGER FUNDED AND THE NEXT FUNDING CYCLE, IN TERMS OF PRIORITIES AND PROCEDURES IS EXPECTED. SO,000 ARE JUST SOME SUMMARY MILESTONES AT THE HEART OF THE INVESTMENT. TO DATE THERE ARE 18 FDA AND THREE CYCLES AND 16 CERTIFIED TESTS FOR PROTOCOLS. THERE'S A VERY LARGE CLINICAL REFERENCE SAMPLE SET EXPANDED TO COLON, PANCREAS AND WHEN WE COMPARE THE RO1 GRANTS WE FOUND THERE WAS A PATENT DIFFERENCE 19-0 PRE APPROVED PROTOCOL TEST DIFFERENCE AND TWICE THE NUMBER OF PUBLICATIONS INCLUDING TWICE THE NUMBER OF PATIENTS ALMOST TWICE FOR IMPACT. WE REVIEWED THE COORDINATION CENTER FOR INVESTIGATOR INITIATED UNBIASSED RESEARCH ON BIOMARKER DISCOVERY. I'M NOT GOING TO RUN THROUGH THIS ENTIRE LIST. THIS IS THE DIAGNOSTIC TEST USED AND REIMBURSED. THERE'S ALMOST A DOZEN. SOME EXAMPLES IN THE NEXT COUPLE SLIDES FDA APPROVE TESTIFIED WITH SIGNIFICANT CLINICAL APPLICATION TO FDA APPROVED ASSAYS. DETERMINE RISK OF MALIGNANCY WITH THOSE LIVING WITH MASSES REFERRED TO AS GYNECOLOGY [INDISCERNIBLE] AND ONE EXAMPLE ANOTHER ADVANCE IS IMPERVIOUS SPECIFICITY FOR CANCER SCREENING AND THE MIPs SCORE AND HELPS EVALUATE PATIENT'S RISK OF PROSTA PROSTATE KEARN AND IT'S UP TO 27% OF BIOPSIES. THE FINDINGS INFORM GUIDELINES FOR COLON CANCER AND INVESTIGATORS IN ARE NOW IN DISCUSSION WITH THE FDA AND FINALLY BIOMARKERS TO STRATIFY EFFICIENTS WITH LUNG CANCER SCREENING. I WANT TO HIGHLIGHT THIS HELPED INITIATIVE IATE THE BIOPSY PROTECTION THERE'S FUNDING PROGRAMS AND AS MENTIONED EARLIER THERE ARE MORE THAN 330 ASSOCIATE MEMBERS FOR PARTNERS TO VALIDATE THE BIOMARKERS AND ACCESS THE REFERENCE SETS AND EXPENSIVE DEVELOPMENT OF METHODOLOGIES AND NOVEL PURCHASE. AND NEW TECHNOLOGIES AND RESOURCES INCLUDING INFORMATICS AND JUST TO HIGHLIGHT THE FUNDING GRANTEES FOR CANCER CENTERS AND A COLLABORATIVE COMMUNITY. CONTRIBUTIONS TOWARDS NON-DIAGNOSTIC DEVICES AND THERE'S A LONG LIST HERE. LIKE THE LUNAR LANDING THERE'S BEEN THE DEVELOPMENT OF NEW TECHNOLOGIES AND METHODOLOGY THAT'S WILL HAVE LONG-LASTING IMPACT NOT LEAST OF WHICH IS CERTAINLY WITH A BIOPSY AND MORE IN IMAGING AND ANALYSIS. AND THEY CAN WORK CLOSELY WICK -- WITH THE ATLAS CENTERS TO IDENTIFY PRECANCEROUS LESIONS WHICH WILL DOVETAIL INTO THE INITIATIVE. OTHER PRIORITIES IN THE NEXT CYCLE BASED ON THE CT RECOMMENDATIONS GOING THROUGH WITH DATA SCIENCE AND ARTIFICIAL INTELLIGENCE AND BIOMARKERS AND MULTI CANCER SCREENING AND INCREASED EFFORTS ON INCLUSION AROUND DIVERSITY AND EFFORTS ON EARLY STAGE JUNIOR INVESTIGATORS. >> THIS IS THE FUNDING TABLE TO SUMMARIZE WE'RE ASKING FOR THESE AMOUNTS AND IT DOES NOT INCLUDE THE TO% CUT BUT IT WILL BE MERITORIOUS APPLICATIONS. THERE CAN BE GREATER VALIDATION IN OUT YEARS OF THE RENEWAL. AND JUST FOR REFERENCE HERE THE COST FUNDING LEVEL IS ABOUT $25 MILLION. SO WITH JUSTIFICATION THIS IS MY LAST SLIDE ISSUANCE REQUEST THEY VALUE THE ROI LIKELY TO INCREASE FROM GIVEN THE MATCH ART OF THE INFRASTRUCTURE WITH THE POTENTIAL TO TACKLE MORE COMPLEX QUESTIONS AND MAINTAIN A COLLABORATI COLLABORATIVE EFFORTS AND ACCELERATE THE DEVELOPMENT OF BIOMARKERS THERE WILL CHANGE PRACTICE CRITICAL TO THE MISSION OF NCI AND ENSURE DATA REPRODUCABILITY AND NEGATIVE FINDINGS ARE AS IMPORTANT AS TOSS PIF ONES AND CHECKS AND BALANCES FOR UNSUBSTANTIATED CLAIMS AND INCREASES WILL COVER ADDITIONAL CLINICAL UTILITY STUDIES AND MORE SUPPORT FOR INVESTIGATORS AND INCREASE INVESTMENT IN DATA ANALYTICS AND MODELLING AND IMAGE ANALYSIS AND INCREASE ACCRUAL FOR UNDER REPRESENTED POPULATIONS. OF COURSE THE ACTUAL IMPACT ON THE BUDGET OR THE PROGRAMATIC COSTS ARE BASED ON THE NUMBER OF SUPPORTS. THANK YOU TO THE REVIEWERS FOR THEIR EXCELLENT FEEDBACK. >> THE PRESENTATION IS OPEN FOR THE BSA REVIEWERS TO MAKE THEIR COMMENT. >> THANK YOU TO DR. CASTLE WHICH RESPONDS TO THE ASPECT THE SUBCOMMITTEE RAISED AFTER WE REVIEWED WHAT HAS TO BE ONE OF THE MOST EXTENSIVE SET OF DOCUMENTS FORRE-ISSUANCE I'VE ENCOUNTERED AND COMPREHENSIVE AND PROVIDED ONGOING AND OVERVIEW OF THE PROGRESS OVER THE PAST FIVE YEARS AS WELL AS TYING IT INTO THE OVERALL HISTORY OF THE EDRN. SO WITH THAT, WE HAD A SERIES OF QUESTIONS AS DR. CASTLE OUTLINED AND WE HAD A PRODUCTIVE DISCUSSION WITH DR. CASTLE AS WELL AS MANY OF HIS COLLEAGUES. [LISTI [LISTING DOCTORS] AND JUST TO TOUCH ON A COUPLE OF THE POINTS THAT WAS RAISED BY PHIL IN HIS PRESENTATION, WE DID THINK WE WERE CONVINCED THERE HAS BEEN GOOD RETURN ON INVESTMENT OVER THE 20 YEARS OF THIS PROGRAM BESIDES THE USUAL METRICS OF FDA APPROVALS AND PATENTS AND CLIA CERTIFIED TESTING AND SO FORTH WE WERE CONVINCED THERE'S BEEN TRUE CLINICAL IMPACT. THERE'S BEEN USE OF THE PRODUCTS AND THE DEVICES AND THE PROCESS INTO CLINICAL PRACTICE AND UTILIZED IT WITHIN THE COOPERATIVE GROUPS AND CLINICAL TRIALS SETTINGS. WE DID FEEL THE RETURN ON INVESTMENT HAS BEEN THERE FOR THIS PROGRAM. THE OTHER THING TOO OBVIOUSLY WITH OVER TIME IN A 20 YEAR PROGRAM YOU WANT TO MAKE SURE THERE ISN'T REDUNDANCIES. THERE AREN'T ANY OTHER MECHANISMS THAT MIGHT EXIST FOR THE DEVELOPMENT TESTING AND VALIDATION OF BIOMARKERS AND NEW TECHNOLOGIES. AND WE WERE CONVINCED THAT NCI ISN'T SUPPORTING OTHER MECHANISMS THAT REALLY DO OVERLAP DIRECTLY JUST AS WE SAW YESTERDAY WITH THE CAPEX PROPOSAL AND SO ON, EDRN IS A NICE COMPLIMENT TO CREATING WHAT ESSENTIALLY IS A REALLY STRONG PIPELINE TO GO FROM DISCOVERY ALL THE WAY TO IMPLEMENTATION FOR MANY OF THESE BIOMARKERS. ALSO, WE WERE CONVINCED IF THIS WASN'T APPROVED, IF THIS PROGRAM DIDN'T GO FORWARD, THERE REALLY WOULDN'T BE -- THERE'S NOTHING TO REALLY TAKE ITS PLACE. IT WOULD CREATE A MAJOR GAP IN TERMS OF THAT ALLOWS THAT CONTINUE UP THAT PIPELINE. SO OVERALL WE SAW THERE'S BEEN INCREDIBLY STRONG INFRASTRUCTURE DEVELOPED OVER TIME. IT'S BEEN MONITORED VERY CLOSELY AND WE THINK THIS IS SOMETHING THAT REALLY SHOULD BE GOING FORWARD. ANOTHER POINT I THINK REALLY IMPORTANT AND THAT'S WHEN DR. CASTLE MENTIONED IN HIS PRESENTATION IS THERE'S AN INCREDIBLE AMOUNT OF VALUE ADDED BY EDRN. IN TERMS OF THE ESTABLISHMENT OF NEW CONSORTIA AND COLLABORATIVE PROJECTS WHICH SPAN INVESTIGATORS GETTING RO1, PO1 GRANTS THAT INCLUDE DEVELOPMENT OF BIOMARKERS AND DISCOVERY OF BIOMARKERS AND DEVELOPMENT OF NEW DEVICES. SO I THINK THAT THE VALUE-ADDED IS SOMETHING THAT WE CAN'T UNDERESTIMATE FOR EDRN AND LASTLY GOING FORWARD I THINK THE NCT AND THE REPORT IS NICELY AND GAVE EXCEPTIONAL RESEARCH OPPORTUNITIES FOR EDRN IN THE FUTURE THAT COULD CAPITALIZE ON CURRENT ADVANCES ON SCIENCE AND TECHNOLOGY AND HOW THIS IS GOING TO KEEP UP WITH THE ADVANCES AND CAPITALIZE THEM GOING FORWARD. AND DOES ANYBODY HAVE COMMENTS THEY'D LIKE TO MAKE. >> I WANT TO THANK PHIL AND HIS GROUP FOR THE EXCELLENT PRESENTATION BECAUSE YOU ADDRESSED OUR CONCERNS AND LAST WAS THE CLIENTS IN EDRN AND THEY'RE MOVING FORWARD AND INCORPORATING NOVEL METHODOLOGIES AND OTHER TYPES OF THINGS INTO THEIR FUTURE PLANS. I WAS REALLY IMPRESSED BECAUSE WE WERE CONCERNED THE BOARD WOULD LOOK AT THIS AND IT'S A BIG TICKET ITEM AND ALMOST $177 MILLION AND WE WANTED TO REASSURE OUR COLLEAGUES THAT WE LOOKED AT THIS VERY CAREFULLY AND FELT CONFIDENT THAT THE WORK THEY WERE PROPOSING AND THE HISTORY OF WHAT THEY'VE ALREADY DONE AND THEIR PAST HISTORY SHOWS THAT WE FEEL LIKE THIS IS SOMETHING TO MOVE FORWARD WITH AND THERE WILL BE SUCCESSES FOR SCIENCE IN CANCER AND BIOMARKERS IS REALLY THE AREA WE NEED TO MOVE IN AS WE MOVE FORWARD AND I WAS IMPRESSED WITH THE WORK THEY'VE DONE AND THE REPORT THEY INCLUDED WITH OUR EVALUATION. SO THANK YOU. THAT'S ALL I HAVE TO ADD. >> I THINK BOTH YOU AND LEWIS HAVE SUMMARIZED THE ISSUES THAT CLEARLY WERE OUR CONCERNS ON THE INITIAL REVIEW AND THE STRENGTH OF THE TIES OUT TO OTHER INITIATED FROM NCI WAS PART OF THE CONVINCING US OF THE PLATFORM TO KEEP GOING BEYOND JUST THE FUNDING HERE. I THINK I'LL STOP WITH THAT AND PASS IT BACK TO YOU. >> THANK YOU VERY MUCH FOR YOUR PRESENTATION AND CLEAR ASSESSMENT. I WANTED TO INVITE MEMBERS PANEL TO CONTRIBUTE ANY COMMENTS WE MIGHT HAVE. >> THIS IS VISE. I WANT TO -- VICKY, I WANT TO APPLAUD THE LEADERS OF THE PROGRAM TO MAKE IT A PRIORITY TO INCLUDE INDIVIDUALS OF DIVERSE RACE AND ETHNICITY PARTICULARLY IN THE AREA OF LUNG CANCER REALLY PRODUCTIVE SCREENING SIGNATURES HAVE COME FORWARD. I THINK THE PEOPLE THAT DEVELOPED THEM RECOGNIZED THIS AND ENTHUSIASTIC YOU MADE THIS A PRIORITY. JI WANT TO ECHO THE >> I WANT TO ECHO THE COMMENTS AND IT'S BEEN MANY YEARS SINCE I'VE BEEN AT THE EDRN. WHAT'S AMAZING ABOUT THE GROUP AND INVESTIGATORS IS HOW THEY'VE BEEN FLEXIBLE. A LOT OF WHAT WE'VE SEEN AND THE PRESENTATION FIVE YEARS SINCE I'VE LOOKED AT IT CONTINUES TO EVOLVE WITH NEW TECHNOLOGIES AND NEW APPROACHES AND NEW COLLABORATIONS AND I THINK THEY'RE VERY RECEPTIVE TO CRITICISM AND WHAT WE WANT TO SEE IN A PROGRAM THAT'S BEEN AROUND A LONG TIME AND HOPE TO BE AROUND A LONG TIME AND ENTHUSIASTIC SUPPORT. >> I TOO WANT TO CONGRATULATE THE FOLKS RUNNING THE PROGRAM. WHEN DID YOU START THE EDRN BECAUSE I THINK IT'S IMPORTANT AS A LEARNING TOOL A HUGE PAYOFF HERE. LOTS OF THINGS HAVE COME OUT AND WHAT DIDN'T HAPPEN IN JUST FIVE YEARS. THIS IS A LONG-TERM INVESTMENT. CAN YOU TELL ME WHEN YOU STARTED THE EDRN? >> I'D BE HAPPY TO. IT STARTED UP 2000. THE FIRST FIVE YEARS WE WORKED WITH NASA AND JPL AND STANDARDS OF TECHNOLOGY AND OTHER FEDERAL AGENCIES THAT NEEDED INFRASTRUCTURE. AND THE VERY FIRST FIVE YEARS WE ALSO TRIED TO IMPROVE THE SUBSEQUENT CYCLE AND IN WE STARTED IN 2000 AND SINCE 2000 WE HAVE BEEN ABLE TO BRING ALMOST ABOUT EIGHT BIOMARKERS. IF YOU LOOK THE NUMBER OF BIOMARKERS APPROVED -- >> WE'LL HAVE TO ASK YOU TO KEEP YOUR REMARKS SHORT. >> STARTED IN 2000. THANK YOU. >> OKAY. UNLESS SOMEONE HAS A CRITICAL COMMENT FOR THE VOTING THEN I WILL ASK -- JIM, IS THIS SOMETHING THE PANEL NEEDS TO KNOW BEFORE VOTING? >> NO, IT'S MORE FORWARD LOOKING. >> OKAY. >> SO IF YOU CAN DO IT IN FIVE SECONDS THAT'S OKAY. >> I CAN DO IT IN FIVE SECONDS, THANK YOU. >> BUILDING ON WHAT IS COVERED BY THE LEARNING TOOL, THREE-QUARTERS OF THE BUDGET GOES TO THE LABORATORIES THE CDCs AND IT WOULD BE WORTHWHILE TO LOOK AT THAT. THAT'S WHAT PROGRAMS SHOULD LOOK LIKE IN 20 YEARS AND HOW MUCH IS GOING TOWARDS FACILITIES AND PERSONAL RESEARCH COSTS CAN HELP INFORM NCI PLANNING. >> THANK YOU VERY MUCH. >> THANK YOU. I THINK IT'S AN IMPORTANT ANALYTIC TOOL THAT CAN BE USED. WE'LL ME OF TO VOTING. I WOULD LIKE TO ASK FOR A MOTION. >> APPROVE. >> I'LL SECOND. >> DISCUSSION? >> DOES ANYONE [INDISCERNIBLE]. ANY ABSTENTIONS? >> I'LL ABSTAIN. >> I HAVE THREE ABSTENTIONS. >> OKAY. >> OKAY. ARE WE DONE? >> GREAT. >> THE NEXT CONCEPT IS A REISSUE COOPERATIVE AGREEMENT ACQUIRED RESISTANCE TO THERAPY NETWORK ART NET AND THE PRESENTER IS GOING TO BE DR. IVY AND MEMBERS OF THE SUBCOMMITTEE THAT WE REVIEWED ARE MICHELLE AND MARTIN AND I WILL INVIDE TO PRESENT. >> THANK YOU FOR THE OPPORTUNITY TO PRESENT. THIS IS A REISSUANCE AND BECAUSE OF MODIFICATIONS MADE WE HAVE MODIFIED THE NAME ALSO TO THE ACQUIRED RESISTANCE TO THERAPY NETWORK. RIDE LIKE TO TELL YOU WHERE THIS CONCEPTUALLY CAME FROM. AS PART OF THE MOONSHOT RECOMMEND WE WERE LOOKING FOR THERAPY AND THIS WAS TO BE AN INTERDISCIPLINARY INITIATIVE TO PREVENT OR OVERCOME A TUMOR'S ABILITY TO EXIST OR BECOME NON-RESPONSIVE TO CANCER THERAPY. SO THE PHARMACEUTICAL UNDER PINNINGS OF THE CONCEPT IS UNDERSTANDING THE BIOLOGY AND CLINICAL CHALLENGES AND THIS A HIGH PRIORITY AS IT'S A MAJOR CAUSE OF TREATMENT FAILURE. MOST TUMORS ADAPT AND THE UNDERPINNING OF THIS ADAPTATION TO DEVELOPERS IS WHAT WE WANT TO BETTER UNDERSTAND. WE WANTED A FOCUS COORDINATED AND ITERATIVE SET OF INVESTIGATIONS THAT USED PRE-CLINICALAL MODELS AND BASIC WORK AND CLINICAL PERSPECTIVES AND WE FELT STRONGLY THAT BOTH WERE NEEDED. THE GOAL IS TO BRIDGE THE GAP BETWEEN THE BASIC AND CLINICAL TRANSLATIONAL RESEARCH AND THROUGH THIS TO OVERCOME AND IMPROVE SENSITIVITY TO TREATMENT. THIS IS WHAT THE ORIGINAL CONCEPT THE FIRST CONCEPT LOOKED LIKE AND THAT WAS THE DEVELOPMENT OF A DRUG RESISTANT SENSITIVITY NETWORK AND FIVE GRANTS ASSOCIATED AND TOWARDS THE END OF THE LAST YEAR WE ALSO ADDED CENTRAL TO THAT A COORDINATING CENTER. SO THIS LED TO ADDRESS A SPECIFIC PROGRAMMATIC NEED TO PROVIDE BETTER INTEGRATED BASIC PRE-CLINICAL RESEARCH. IT BECAME PART OF THE MOON SHOT INITIATIVE AND THERE WERE 134 PUBLICATIONS AND CITED OVER 500 TILES AND HADDED 12 SUPPLEMENTS AND TWO PROJECTS I'LL TOUCH ON BRIEFLY. THEY'VE INITIATED 25 CLINICAL TRIALS OUT OF THIS WORK AND TWO WE'RE USING AGENTS SO INVESTIGATIONAL DRUGS. THUS IS A HIGH LEVEL OVERVIEW OF THE PROGRAMS. YOU CAN READ THE PART AT THE BOTTOM. WE WANTED AN OPPORTUNITY FOR COLLABORATION WITH THE LABORATORY. IF AWARDED THE SUPPLEMENTS WOULD COLLABORATE AND THE INVESTIGATOR WOULD RECEIVE ADDITIONAL SUPPLEMENTAL FUNDING TO FURTHER FACILITATE THE COLLABORATION WITH THE OUTSIDE INVESTIGATORS. THERE WAS A BROAD AND DIVERSE GROUP OF SUPPLEMENT POLITICALED THE WORK AND ADDED TO THE WORK BEING DONE BY THE DRSN. SO AS PART OF THE REISSUANCE, WE PERFORMED AN EXTERNAL REVIEW OF THE PROGRAM AS A WHOLE AND WE HAD NATIONAL AND INTERNATIONAL REVIEWERS. THEY WERE BOTH FROM ACADEMIC AND PHARMA GROUPS AND BASICALLY WHAT THEY SAID WAS THAT THERE WERE AREAS WE NEEDED TO OPT MIGHT BUT OVERALL THE SITES WERE HIGHLY PRODUCTIVE AND THEY DID SYSTEMATIC TESTING OF COMBINATIONS AND THEY WOULD USE IT FOR MORE SPECIFIC PURPOSE AND HYPOTHESIS TESTING PROJECTS AND FURTHER CONSIDERATION AND EVALUATION PRIOR TO VALIDATION CLINICAL TRIALS. THE DRSN ITSELF INCREASED NETWORK FUNCTIONALITY AND I THINK THERE WERE SOME INTERNAL AND EXTERNAL BARRIERS TO THAT. MOST OF WHICH WE HAVE ADDRESSED PROGRAMMATICALLY AND WE WANTED TO MAKE THE RANGE OF SYSTEMS BETTER AND PRIORITIZE THE FOCUS OF ACQUIRED RESISTANCE AND THAT'S THE PRIMARY FOCUS OF THE RE-ISSUANCE. WE WANTED MODELS OF OCCURRENCE AND WANTED ADAPTIVE RESPONSE TO THERAPY AND STRENGTHEN WAYS TO CONNECT PRECLINICAL FINDINGS WITH CLINICAL VALIDATION. WHAT WE'RE TRYING TO DO IS TIE BASIC AND TRANSLATIONAL RESEARCH TOGETHER TO TESTING APPROACHES. WE IDENTIFIED 47 THE AWARDS OF -- 479 AWARDS IN THE NCI PORTFOLIO. I REFERENCED DRUG RESISTANCE IN SOME WAY WHAT I CAN SAY IS NONE OF THEM WERE JOINTLY HELD PROGRAMS THAT CONNECTED AND INTEGRATED ACROSS THE BASIC CLINICAL AND PRE-CLINICAL SPECTRUM AND THERE WAS AN AREA OF ACQUIRED RESISTANCE AND DISEASE RECURRENCE AND THE OTHER OTHER AREA DEFICIT WAS UNDER WEIGHTED RESEARCH IN THE AREA OF AND THE COMPLEXITIES INVOLVED IN THE TUMOR MICROENVIRONMENT AND HOW THAT MIGHT RELATE TO SYSTEMS. WE DIDN'T FEEL THERE WAS MAJOR OVERLAP HELD IN THE PORTFOLIO. AND WE WANTED TO EXPAND THE SCOPE TO FURTHER FOCUS ON THE AREA OF ACQUIRED RESISTANCE AND WE WANTED TO HAVE A WIDE ARRANGE OF MODALITIES AND TO ESTABLISH AN ITERATIVE BRIDGE BETWEEN BASIC MECHANISTIC AND PRE-CLINICAL AND CLINICAL TRANSLATIONAL SCIENCE. TO ACCOMPLISH THIS WE WANTED ACQUIRED RESISTANCE MECHANISMS AND ASSOCIATED THERAPEUTICS AND COMBINATIONS OR TREATMENT MODALITIES FOR TRIALS. THEY'RE NOT BEING FUNDED TO PERFORM CLINICAL TRIALS JUST TO PROVIDE THE DATA AND RESEARCH FOR SIGNED CLINICAL TRIALS. IN UNDERSTANDING RESISTANCE SENSITIVITY I WANTED TO TOUCH BRIEFLY ON THE UNDER STUDY AND UNDEVELOPED AREAS WE HOPE TO FOCUS THE NETWORK ON FURTHER IN THE FUTURE. THE FIRST WAS TO LOOK AT DYNAMICS AND TUMOR MICRO ENVIRONMENTS AND UNDERSTAND THE REWIRING OF THE VARIETY OF SURVIVAL PATHWAYS AND PLACE A STRONGER EMPHASIS ON HOW THE MICROBIOTA HAS FURTHER RESISTANCE AND DO WORK IN THOSE AND PLACE A STRONGER EMPHASIS ON DISPARITIES RESEARCH AND LEVERAGING A NUMBER OF MODELS THAT HAVE BEEN INVOLVED IN OTHER PROGRAMS WITHIN THE NCI. THIS IS HOW WE VISUALIZE THE ART NET AND WHAT THE U54 CENTER ORGANIZATION REQUIREMENTS ARE. FIRST THERE WAS A REQUIRED STRUCTURE. WE WOULD LIKE EACH APPLICATION AND EACH CENTER TO HAVE A MINIMUM OF THREE PROJECTS AND SO WE PROVIDED SOME EXAMPLES LIKE TWO BASIC MECHANISTIC AND ONE PRE-CLINICAL OR VICE VERSA AND CLEARLY NEEDED TO HAVE RELEVANT [INDISCERNIBLE] THAT HAD RESEARCH AND BIO SPECIMEN EVALUATION AND THE CENTER WOULD BE DEFINED BY A PIE BOTH SIS RELATE -- HYPOTHESIS RELATED TO MECHANISTIC BASIC ACQUIRED RESISTANCE AND HAVE SPECIAL REVIEW CRITERIA THAT HAD TO DO WITH THE RATIONALE AND SIGNIFICANCE AND THE LEVEL OF ITERATION BACK AND FORTH BETWEEN BASIC SCIENCE AND THE CLINIC. THIS IS THE STRUCTURE OF THE ART NET. WE THINK WE'LL HAVE FOUR BUT PERHAPS FIVE RESEARCH PROGRAMS. THEY'LL BE U54 GRANTS AND ONE U24 GRANT THAT LOOKS TO COORDINATE THE DATA MANAGEMENT CENTER AND WHILE BE ASKED TO NETWORK AND COLLABORATE IN THE FUNDING FOR THE AWARD THEY'LL HAVE RESTRICTED FUNDINGS THAT ACCOUNT FOR IS A -- 15% OF THE GRANT AND COLLABORATION AND HOPE IT WILL IMPROVE THE NETWORK CONNECTIVITY TO A LESSER DEGREE. WE ALSO TO ACCOMPLISH THIS WILL AMPLIFY THE ESTABLISHED WORKING GROUP AND AND WE HAVE OTHER CLINICAL AND RESEARCH NETWORKS AND I LISTED THEM AT THE BOTTOM IN THE DIAGRAM. THIS IS THE FUNDING REQUIREMENT. THE FUNDING IS FOR FIVE YEARS AT $7.6 MILLION AND THE TOTAL COST IS FOR $38 MILLION IN TOTAL COST FOR FIVE YEARS. I THINK THAT'S MY LAST SLIDE. WE WANT TO LOOK AT HOW THEY COLLECT AND SHARE AND CURATE SYSTEMS AND SHARE CATALOGS FOR SOFTWARE AND PRE-CLINICAL MODELS AND DATA SHARING TO THE INDUSTRIAL OF INNOVATION TO LOOK AT THE EFFECTIVENESS AND EXPANDING THEIR ORIGINAL NAMES AND TO EVALUATE THE DEVELOPMENT, IMPLEMENTATION AND COORDINATION OF A WORKING GROUP AND AS ALWAYS THE TRACK RECORD ON PUBLICATION. I THINK THAT'S MY LAST SLIDE AND WITH THAT I WOULD BE LAYED TOED TO TAKE ANY QUESTIONS OR ANSWER FURTHER QUESTIONS BASED ON THE REVIEW BY THE BSA. THANK YOU. >> THANK YOU. WE ARE TIGHT ON TIME. I WOULD LIKE TO ASK THE REVIEWERS TO BE AS SUCCINCT AS POSSIBLE SO WE DON'T GET BEHIND SCHEDULE TOO MUCH. MICHELLE I THINK YOU WERE LEADING THE DISCUSSION. >> THANK YOU FOR THE THOUGHTFUL AND THOROUGH RESPONSE TO OUR QUESTIONS. AS YOU HEARD FROM DR. IVY, THIS IS A RE-ISSUANCE OF THE DRSN U54 AND BECAUSE IT'S BEEN ENHANCED AND REVISED TO EXPAND BASED ON THE LESSONS LEARNED FROM THE DRSN AS WELL AS THE ADVICE OF THE EXTERNAL ADVISORY COMMITTEE IT'S BEEN EXPANDED AND RENAMED AS THE ARTNET. WE THE COMMITTEE WAS STRONGLY SUPPORTIVE WITH CONCURRENCE OF THE ONE-TIME REISSUANCE. WE THOUGHT THIS IS A VERY STRONG CLINICAL JUSTIFICATION BECAUSE IT ADDRESSES A PROBLEM OF AFFECTED THERAPY AND THERE'S RICH OPPORTUNITIES TO TAKE ADVANTAGE OF INTEGRATING TO UNDERSTAND TUMOR PLASTICITY AND INTERACTIONS BETWEEN THE TUMOR AND TUMOR MICROENVIRONMENT TO UNDERSTAND THE MECHANISMS OF RESISTANCE AND IN PARTICULAR TO PROPOSE HYPOTHESIS THRIVEN STUDIES THAT WILL ELUCIDATE MECHANISMS OF DRUG RESISTANCE AND ARETIRED -- ACQUIRED MECHANISMS. WE THOUGHT IT WAS TIMELY BECAUSE OF THE OPPORTUNITIES TO HAVE AN ITERATIVE BI-DIRECTIONAL APPROACH FROM BASIC TO CLINICAL AND PRE-CLINICAL AND THE COMPONENTS. PE THE PROOF OF PRINCIPLE AND VALUE DEMONSTRATED BY THE EXISTING DRSN WAS VERY STRONG. IT'S ONLY BEEN IN EXISTENCE THREE YEARS HAS BEEN VERY PRODUCTIVE AND THE EXTERNAL ADVISERS AND HAD AN IMPORTANT RECOMMENDATIONS THAT HAVE NOW BEEN USED TO STRENGTHEN THE ART NET. WE FELT IT WAS THE APPROPRIATE MECHANISM FOR THE STRUCTURE WITH PROJECTS AND A RICH OPPORTUNITY TO INTERACT WITHIN THE CONSORTIUM AND NETWORK AND PROGRAM TO USE 15% OF THE BUDGET TO INCENTIVIZE COLLABORATIONS AND THOUGHT THAT WAS GOING TO BE A VERY IMPORTANT MECHANISM TO PROMOTE INTERACTIONS. WE HAD A ROBUST DISCUSSION ABOUT WHETHER THIS WAS TUMOR AGNOSTIC, HOW TO THIS DIFFERED FROM THE RSN AND HOW THE REVIEWER'S SCIENTIFIC RECOMMENDATION COULD BE ADDRESSED AND MAXIMIZE HYPOTHESIS DRIVEN RESEARCH AND WERE VERY COMFORTABLE THAT DR. IVY AND HER COLLEAGUES HAD TAKEN PROMOTE MEASURES TO ENSURE THESE WOULD BE TAKEN. WE WERE VERY SUPPORTIVE AND I'D LIKE TO TURN IT OVER TO MY COLLEAGUES DR. SEWALT AND MYSELF. >> MICHELLE HAS BEEN QUITE THOROUGH. NOTHING TO HAD. >> ANY FURTHER COMMENTS FROM THE PANEL OR QUESTIONS BEFORE WE MOVE TO VOTING? >> ONE QUICK QUESTION. CAN YOU SPEAK TO THE FACT THAT ACQUIRED RESISTANCE IS A VERY ROBUST LIVE INVESTIGATION IN CANCER RESEARCH. CAN YOU MENTION HOW THIS SEPARATES OR PROVIDES A UNIQUE ADVANTAGE TO BASICALLY RO1s GOING AFTER THE SAME QUESTION? >> I HOPE THAT WE'VE PRESENTED OR MAYBE I NEED TO STRENGTHEN MY PORTFOLIO RA -- ANALYSIS. THERE'S RO1s AND OTHERS ADDRESSING THE QUESTION OF RESISTANCE AND WHAT THEY HAVE NOT REVIEWED IS THE TRANSLATIONAL COMPONENT. THE GOING BACK AND FORTH BETWEEN BASIC RESEARCH AND PRE-CLINICAL RESEARCH DIRECTED AT DESIGNING THE CLINICAL TRIAL AND THE KIND OF INFORMATION YOU NEED FOR THAT AND CLINICAL RESEARCH AND THE OTHER ASPECT IS IF CLINICAL RESEARCHERS IDENTIFY A CLINICAL PROBLEM FOR WHICH THEY DON'T HAVE THE BASIC RESEARCH DATA TO MOVE FORWARD THEN WE CAN SHUTTLE AND FOSTER THOSE COLLABORATIONS TO GET THAT INFORMATION SO THEY CAN MOVE FORWARD CLINICALLY. I THINK THAT IS THE DIFFERENCE. THIS PROPOSAL IS VERY UNIQUE FROM THAT PERSPECTIVE AND THE REVIEW OF THE CURRENT NCI GRANT PORTFOLIO RELATED TO DRUG RESISTANCE. >> SUPER. THANK YOU. >> THANK YOU VERY MUCH FOR THE CLARIFICATION. >> SO WITH THAT WE'LL MOVE TO VOTING. I WOULD LIKE TO ASK FOR A MOTION. >> SO MOVED. >> ANY FURTHER DISCUSSION? OKAY, DOES ANYONE NOT CONCUR? ANY ABSTENTIONS? >> TWO. >> OKAY. >> THE NEXT CONCEPT IS A NEW RFA PANCREATIC DUCTAL ADENO CARCINOMA STROMAL REPROGRAMMING CONSORTIUM AND THE PANEL THAT REVIEWED ARE [LISTING NAMES] >> THANK YOU VERY MUCH. THANK YOU TO THE BSA FOR LETTING US PRESENT TO YOU. IN ORDER TO SHOW YOU THE JUSTIFICATION FOR OUR INTENT TO CREATE THIS CONSORTIUM, I'D LIKE TO GO THROUGH THE CLINICAL AND BIOLOGY CHALLENGES WE'RE FACING. STANDARD OF CARE FOR ADVANCED PDAC INVOLVES SURGERY, CHEMOTHERAPY AND RADIATION TO TARGET THE TUMOR MASS. SYSTEMIC TREATMENT DID LITTLE TO ADDRESS THE BLEED OF PATIENTS AND A QUARTER OF THE COMBINATION OF FOLFIRINOX AND OTHERS HAD LIMITED USE. RECENT ATTEMPTED TO ENHANCE DRUG DELIVERY AND MODULATE THE VASCULAR IMMUNE MICROENVIRONMENT RESULTED IN PARTIAL SUCCESSES. THE CLINICAL FACTS WE BELIEVE ARE BASED ON THE ONGOING DISCONNECT BETWEEN BASIC AND TRANSLATIONAL RESOURCE THAT PRECLUDED CHARACTERIZATION OF STROMAL TARGETS. THIS IS FURTHER EXACERBATED BY THE INEFFICIENT BIOLOGICAL STUDIES AND THE ROLE OF STROMAL ORGANIZERS AS IN EFFECT. THIS WILL BUILD ON THE PANCREATIC CANCER NETWORK AND A MOONSHOT THAT WILL EXPIRE NEXT YEAR. THIS CONSORTIUM IS FOCUSSED ON THE IMMUNE RESPONSES WITHIN. THESE ARE FIVE PROJECTS AND IT'S A HIGHLY PRODUCTIVE CONSORTIUM AND HAVE PUBLICATIONS AND THERE'S INVESTIGATORS FROM ACROSS THE UNITED STATES AS SUPPORT MEMBERS. THERE ARE SEVERAL TRIAL COOPERATIVE PROJECTS STARTED AND THE RESOURCE AND THERE'S HIGHLIGHTS AND ACHIECHLTS. FIRST I'D LIKE TO MENTION A STUDY CONDUCTED BY THE GROUP LED BY -- ACHIEVEMENTS. THAT HELPED INFORM WITH CLINICAL TRIALS WITH PROMISING RESULTS. ANOTHER DEALS WITH VACCINE STUDIES AND LED TO A PHASE 1 CLINICAL TRIAL. THE NEXT SLIDE WILL SHOW HOW WE CAN ADDRESS ISSUES. THESE ARE THE CHALLENGES AND GAPS. THE PSRC IS GOING TO ADDRESS THESE. DEVELOP THE COMMUNITY OF PDAC RESEARCHERS TO EXPAND UPON TRADITIONAL TUMOR AC CENTRIC STUDIES AND ALMOSTS DRIVING PROGRESSION AND RESPONSE TO THERAPY. AND THIS IS BY A RESEARCH MODEL IN THE PURSUIT OF NOVEL BIOLOGICALLY BASED TARGETS TO INTERRUPT THE TUMOR SUSTAINING DYNAMICS. HOPEFULLY THIS WILL INFORM THE DESIGN AND TESTING OF MORE EFFECTIVE COMBINING APPROACHES AND USING PDAC AND THE PSRC PROGRAMS SHOULD FURTHER STIMULATE OTHER CANCER PLATFORMS. THIS CONSORTIUM SHOULD BUILD ON AND EVENTUALLY REPLACE THE OTHER ONGOING NCI SPONSORS PROGRAMS SUCH AS THE SPORES AND PANCREATIC CANCER DETECTION CONSORTIUM AND OTHERS. PSRC WILL REACH SIGNS WITH PRE CLINICAL TRANSLATIONAL SIGNS BY THE ENVIRONMENT DRIVERS OF TUMOR PROGRESSION AND RESPONSE TO THERAPY. INVESTIGATION OF EXTRA CELLULAR MATRIX FROM EPITHELIAL CELL BEHAVIOR AND THE PSRC PROGRAM INTENDS TO FURTHER CULTIVATE AND SUPPORT TUMOR CELL INTRINSICS AND THEY MUST TRIANGULATE WITH THE TRANSLATIONAL AREAS HIGHLIGHTED HERE. I PUT FIBROBLASTS AND THEY'RE THE PRIMARY SOURCE OF VASCULAR COLLAPSE AND IMMUNE LOGICALLY TUMOR MICROENVIRONMENT. HOWEVER, SHOWS PRESSURE OR ELIMINATION OF ACTIVATED CATS AND BLOCKADE OF SONIC HEDGEHOG AND CGS BETA SIGNALLING IN THESE EFFECTS TUMORS JUST GROW STRONGER. THERE'S THE ROLE OF NUMEROUS OTHER STROMAL CELL TYPES THAT REMAIN POORLY UNDERSTAND AND UNDER STUDIES. THESE ARE NEUROTUMOR INTERACTIONS AND ENDOTHELIAL INTERACTIONS IN AGGRESSIVENESS AND ADD POSE TISSUE MEDIATED THERAPY RESISTANCE. LASTLY, THERE'S ALSO A MICROBIOME BUT THAT'S OFTEN OVERLOOKED IN THE TME COMPONENT. WHEREVER POSSIBLE WE'D LIKE OUR INVESTIGATORS TO STUDY THESE IN THE CONTEXT OF RESEARCH AS YOU KNOW IT'S UNDER DEVELOPED AND IMPORTANT TO FOLLOW. THE ANALYSIS REVEALED 50% OF THE CURRENTLY FUNDED GRANTS BY THE NCI FOCUS ON TUMOR CELLS. ONE THIRD FOCUSES ON THE TME. THERE'S ABOUT 18% FOCUSSING ON NON-IMMUNE TME AND 5% CROSS-CUTTING TME. HOWEVER, IF YOU LOOK AT STROMAL DRIVES 7 OUT OF THE 149 GRANTS FOCUS ON THAT AREA. THIS IS WHERE OUR FOCUS SHOULD BE. OUR VISION IS THAT WE'D LIKE TO FUND SIX RESEARCH PROGRAMS. EACH URL 1 WILL HAVE COMPLIMENTARY MULTI PI AND TRANSLATIONAL RESEARCH AREAS. THEY SHOULD HAVE ACCESS TO CLINICAL SUPPRESS -- SPECIMENS AND BIOLOGY INFRASTRUCTURE. THIS WILL BE COMPLIMENTED BY THE U24 COORDINATING AND CENTER WITH MULTIPLE FUNCTIONS. WE WOULD LIKE IT SUPPORT THE NETWORKING IN THE MEASURES. RESTRICTED FUNDS FROM COLLABORATIONS AND 15% OF THE BUDGET IN EACH GRANT AND ADDRESS COMMON GOALS AND SHARING OF TOOLS AND SOURCES AND REQUIRED STEERING COMMITTEE LED MEETINGS AND INCLUDING OF ASSOCIATE MEMBERS CAN BE HELPFUL. SPECIFICALLY THE STEERING COMMITTEE AND WORKING GROUP ACTIVITIES SHOULD FOCUS ON PRIORITIZATION AND LEVERAGING RESOURCES OF THE CONSORTIUM WITH NCI RESOURCES [AUDIO DIGITIZING] AND BROADER RESOURCES AND THE DEVELOPMENT OF RESEARCH TOOLS AND APPLICATIONS FOR PATIENT MANAGEMENT. AND WE ARE PLANNING SIX PLUS ONE GRANTS EACH OF THEM $600,000 DIRECT COST FOR THE FIRST YEAR WHICH IS PRORATED TO $6.93 MILLION FOR THE FIRST YEAR AND $34.65 MILLION FOR THE GRANT TOTAL. THANK YOU VERY MUCH AND I'D LIKE TO SPECIALLY THANK OUR THREE REVIEWERS FOR VALUABLE SUGGESTIONS AND COMMENTS. >> THANK YOU VERY MUCH. DAVE COULD NOT BE WITH US AND HE SENT WRITTEN COMMENTS I WAS TRYING TO MARRIAGE WITH THE OTHER COMMENTS ABOUT A HALF AN HOUR AGO SO FORGIVE ME IF IT SOUNDS CHOPPY BUT TRYING TO INTEGRATE EVERYTHING TOGETHER. IT WAS DAVE, MARY AND MYSELF THAT MET WITH PETER AND JEFF TWICE. WE REVIEWED THE PROPOSAL. IN PRINCIPAL WE'RE ALL EXTREMELY SUPPORTIVE OF THE CONCEPT. THE SCIENTIFIC AREAS THEY COVER ARE CENTRAL TO WHAT DRIVES PDAC. THE MAJOR QUESTION THE FIRST WAS RELATED TO METRIC OF SUCCESS WHICH PETER OUTLINED VERY NICELY AT THE END OF HIS PRESENTATION. THE SECOND ONE IS IN FACT ECHOING SOME OF THE DISCUSSION WE ALREADY STARTED YESTERDAY CONCERNING THE ROLES OF THE U24s AND THE NEED PERHAPS TO THINK HOW THEY CAN DIFFERENTIATE THEMSELVES AND IN RESPECT TO PARTICULAR PROGRAMS. THE DISCUSSION RAISED HAD TO DO WITH THE FACT THAT AT THE VERY LEAST DAVE AND I AS INDIVIDUALS IMMERSED IN THIS PARTICULAR FIELD FELT THAT ONE OF THE RATE LIMITING STEPS IN CONDUCTING THESE IMPORTANT STUDIES IS THE LACK OF AVAILABILITY TO FACILITIES OR TO CAPABILITIES THAT ALLOW PRE-CLINICAL STUDIES. THESE ARE THE ONLY SMALL CENTERS AROUND THE COUNTRY THAT CAN DO THESE TYPES OF ANALYSIS IN MODELS OR IN SLIGHTLY MORE REDUCTIONIST MODELS REQUIRES OF COURSE THE CAPABILITY TO DO ULTRASOUND AND A LOT OF OTHER THINGS THAT NEED TO BE PERHAPS WILL AUGMENT THE GOAL OF THIS PROGRAM WHICH IS REALLY TO TAKE THE FINDING THE BIOLOGY INTO POTENTIALLY TRANSLATIONAL ARENAS. THE QUESTION RAISED IS WHETHER THE U24 IN THIS PARTICULAR CASE COULD ADDRESS THE NEEDS BY HAVING A CENTRALIZED CAPABILITY TO DO THESE TYPES OF PRE-CLINICAL STUDIES. THE OTHER QUESTION IS AN INTERESTING CONCEPT THIS IS A CONTINUATION OF THE MOON SHOT INITIATIVE FOR A PROGRAM FUNDED BY THE MOONSHOT INITIATIVE AND I'LL TURN IT OVER TO MARY AND YESTERDAY WE DISCUSSED IT AND FELT IT WOULD BE IMPORTANT TO UNDERSTAND WHETHER THIS IS THE BEST MECHANISM TO FUND RESEARCH IN THESE AREAS. AGAIN, THE QUESTION WE HAD YESTERDAY OTHER ONES VERSUS UR1s WHETHER WE NEED TO LOOK AT IT MORE CAREFULLY KNOWING IT'S A PROGRAM THAT WAS FUNDED BY ADDITIONAL MONEY THE NCI RECEIVED BUT IS NOW BECOMING PART OF OUR POOLS. MARY AND ED IF I SKIPPED SOMETHING, GO AHEAD. >> THANK YOU. I THINK SHE DID A GREAT JOB OF THE VIEWS AND I WAS ENTHUSIASTIC FOR THE PROJECT FOR THE REASONS MENTIONED. THE FACT IT ADDRESSES A MAJOR UNMET MEDICAL NEED IN THE AREA OF PDAC AND IS A NEW AREA WHERE DETAILED INVESTIGATION WOULD BE VERY PROMISING AND THAT IS MORE OF A FOCUS ON THE CO-ORGANIZER ASPECTS OF THE TUMOR MICROENVIRONMENT. AND PARTICULARLY THE NON-IMMUNE TUMOR MICROENVIRONMENT LIKE THE FIBROBLAST NEURONS AND ENDOTHELIAL CELLS WHERE WE HAVE EVIDENCE THERE'S IMPORTANT FUNCTIONAL IMPACT BUT WE DON'T REALLY HAVE WAYS TO TARGET THAT OR UNDERSTAND THE DETAILED MECHANISTIC CONTRIBUTIONS TO TUMOR PROGRESSION OR RESISTANCE TO THERAPY. I THINK WE WERE ALL UNIFORMLY ENTHUSIASTIC AND THE ISSUE BROUGHT UP AT THE ENDS CAME ULT IN THE COURSE OF -- CAME UP IN THE COURSE OF OUR BSA DISCUSSIONS WHICH IS HOW WE WISELY ADDRESS CONTINUATION OF MOON SHOT EFRTHS WHEN WE DON'T REALLY -- EFFORTS WHEN WE DON'T UNDERSTAND WHERE THE RESOURCES WILL BE COMING FROM. REMAIN ENTHUSIASTIC AND ASK GOING FORWARD. >> IT'S ABOTCH MY PAY GRADE I DEFER TO YOU AND DAVE AND ONE THING THAT CAME FROM THE DISCUSSION IS THE IDEA THE TUMOR MICROENVIRONMENT IS IN DEPENDENT OF THE TUMOR. I THINK ONE OF THE STARTLING LESSONS OF THE LUNG CANCER PATIENTS HAD DRAMATIC RESPONSE WHY YOU CAN SWITCH THE MASS MUTATION AND SEE WHAT IT DOES TO THE MICRO ENVIRONMENT. >> I DON'T KNOW IF YOU WANT TO ADD ANYTHING AND WE'LL MOVE TO VOTING AFTER. BOB. >> THAT'S A GOOD QUESTION. I LIKE YOUR ANSWER. THE AUTHORS OF THE CONCEPT VERY MUCH EMPHASIZE COORDINATION OF TME ASPECTS WITH TUMOR INTRINSIC ASPECTS AND IMMUNE CELL ASPECTS. I DON'T THINK THERE'S ANY INTENTION TO SILOIZE IN THIS REGARD BUT MAKE SURE THE THIRD DIMENSION IS STUDIED MECHANISTICALLY AS WELL. >> IT MAKES SENSE STO -- TO ME. THAT SOUNDS GOOD. >> OKAY. WE'LL MOVE FOR TO VOTING. >> OKAY. MOVING TO THE NEXT CONCEPT RESEARCH FOR MOLECULAR IMAGING IN CANCER. >> THE FOR THE OPPORTUNITY TO PRESENT OUR CONCEPT FOR MOLECULAR IMAGING AND I AM -- INFLAMMATION IN CANCER AND THANK THE REVIEWSER FOR THE COMMENTS THEY HAD. REVIEWERS AND ADDITIONAL COMMENTS THEY HAD. AS THE TITLE SUGGESTS THIS IS IS A PAR FOR MOLECULAR IMAGING AND INFLAMMATION. WE CONSULTED A NUMBER OF BIOLOGY AND IMAGING EXPERTS AND DEVELOPMENT OF THIS CONCEPT BUT WHERE IT BEGAN WAS FROM THE TWO DISCUSSIONS THAT AROSE FROM TWO TRANS-NIH WORKSHOPS ON CHRONIC INFLAMMATION AND WHAT BECAME APPARENT IS THERE'S A NUMBER OF NEEDS IN CANCER AS WELL AS OTHER DISEASE TYPES THAT HAVE INFLAMMATORY PROCESSES AT WORK. OF COURSE WE ALL KNOW INFLAMMATION AND THERE'S A LOT OF STUDIES IN INFLAMMATION IN TREATMENT AND TUMOR RESPONSES AND IT'S DYNAMIC AND HETEROGENEOUS AND THOUGHT MOLECULAR IMAGING TECHNIQUES CAN PROVIDE A METHOD FOR THE DYNAMICS AND HETEROGENEITY AND AS A RESULT OF THE WORKSHOP ON CHRONIC INFLAMMATION THERE WAS A NEED FOR IMAGING TOOLS AND APPROACHES FOR CANCER INFORMATION. >> WHEN WE LOOKED AT A PORTFOLIO AT THE NCI, THERE ARE NOT MANY PROJECT HAVE BEEN FUNDED BY THE NCI IN CANCER IMAGING AND IN INFLAMMATION AND THIS IS I PORTFOLIO LACK COMPARED TO WHAT IS GOING ON IN OTHER INSTITUTES. ONE IDEA IS TO BRING OTHER APPROACHES TO CANCER QUESTIONS AND HOW TO DO THAT AND THAT IS TO WORK WITH THE CANCER BIOLOGY SCIENTISTS TO HAVE THEM HELP IDENTIFY IMPORTANT INFLAMMATION PAR -- TARGETS FOR IMAGING AGENTS NA HAVE BEEN DEVELOPED. THAT'S IDENTIFY NEW TARGETS FOR DEVELOPING NEW MOLECULES AS WELL AS BRINGING EXISTING IMAGING AGENTS TO SOME OF THESE QUESTIONS. SO OF COURSE WE WOULD EXPECT THAT THE IMAGING COMMUNITY WOULD APPLY IT'S USUAL TECHNIQUES FOR CHARACTERIZING MOLECULES AND THEIR PERFORMANCE BUT THE IMPORTANT POINT IS THE INTERACTION BETWEEN THE CANCER BIOLOGISTS AND THE IMAGING SCIENTISTS TO DEVELOP AND HAVE AN INTERACTIVE APPROACH TO IMMUNOLOGY AND HOW IT CAN CONTRIBUTE TO BIOLOGICAL LABORATORY SCIENCE AND WE EXPECT THIS TO BE A TWO-WAY STREET AN ROBUST COLLABORATION WHICH HAS BEEN PRETTY WEAK AS FAR AS WE CAN TELL. HERE'S EXAMPLES OF IMAGING INFLAMMATION APPLIED TO CANCER AND COULD HAVE PULLED THEM FROM CLASS RASH -- VASCULAR DISEASES AND MUSCULODISEASES AND WE HAVE AN MR IMAGE SHOWING AN EARLY RESPONSE TO ANDROGEN ABLATION THERAPY AND NEXT THERE'S A SMALL ANIMAL IMAGE OF TUMOR IN A HOUSE TREATED SHOWING AREAS OF APOPTOSIS AND THE LAST SLIDE IS ANOTHER SPEC IMAGE THIS TIME OF FIBROBLASTIC TRACER AS A SURROGATE BIOMARKER FOR REDUCED LEVELS. I KNOW THIS IS UNDERGOING EARLY CLINICAL TRIALS IN PATIENTS WITH A VARIETY OF DIFFERENT TUMORS. SO AS I MENTIONED EARLIER, MANY PROMISING MOLECULAR IMAGING PROBES HAVE BEEN INVOLVED FOR OTHER CANCER APPLICATIONS AND THERE ARE PROBABLY NEW TARGETS THAT THE CANCER BIOLOGY COMMUNITY WOULD CONSIDER TO BE RELEVANT FOR IMAGING APPLICATIONS AS WELL. THE POINT IS WE'D LIKE TO JOIN THE TWO COMMUNITIES AND GROUPS OF SICIENTISTS TO FURTHER OUR UNDERSTANDING OF CANCER INFLAMMATION AND CELLULAR PHYSIOLOGY AND FURTHER PROCESS AND RESEARCH THESE IMPORTANT BIOLOGICAL QUESTIONS. SO WHAT ARE WE REALLY TALKING ABOUT MOLECULAR IMAGING CONCEPTS AND IDEAS. TO APPLY TECHNIQUES NON-INVASIVE AND REPEATABLE AND FAST. VERY FAST AT THE TIME OF CHEMICAL TRANSITION TO OBSERVE AS CHEMICAL PROCESSES ARE OCCURRING. OF COURSE THEY NEED TO BE QUANTITATIVE SPECIFIC, SENSITIVE, HAVE HIGH SPATIAL RESOLUTION AND ROBUST APPLICATION PACKAGES FOR IMAGE AND DATA ANALYSIS WHICH IS EXTREMELY IMPORTANT FOR INTERPRETATION OF THE RESULTS. DYNAMIC MEASUREMENTS NEED TO BE VERY ROBUST AND ADVANCED SO WE CAN LOOK AT SPECIFIC INTERACTIONS BETWEEN DIFFERENT MOLECULES, CELLULAR GROUPS AND TUMOR ETCETERA THROUGHOUT THE TUMOR ENVIRONMENT AS WELL AS THE TUMOR ITSELF. WE FOCUS THE CONCEPT ON CANCERS WITH NON-INFLAMMATORY ASSOCIATION OF NON-VIRAL ORIGIN. THESE APPROACHES SHOULD BE HYPOTHESIS DRIVEN WITH AN AGREEMENT AND COLLABORATION BETWEEN THE IMAGING SCIENTISTS AND CANCER BIOLOGISTS. HERE'S WHAT WE ENVISION RO1s FOR FIVE YEAR PROGRAM ANNOUNCEMENT WITH TWO RECEIPT DATES PER YEAR. AND REVIEW BY STANDING STUDY SECTIONS WITH SPECIAL REVIEW CRITERIA WHICH EMPHASIZE COLLABORATION BETWEEN THE SCIENTIFIC GROUPS AND IDENTIFICATION OF APPROPRIATE TARGETS AND HOW THEY'LL TRANSFER INFLAMMATION. IT'S A SHORT PRESENTATION BUT WITH THAT I'LL STOP. >> I'LL INVITE SILVIA TO START US OFF. >> THANK YOU. WE HAD A PRODUCTIVE CALL. ALL THE SUBCOMMITTEE MEMBERS EXPRESSED ENTHUSIASM AND SUPPORT FOR THE CONCEPT. WE ALL AGREE IT'S IMPORTANT TO DEVELOP AND APPLY MOLECULAR IMAGING CAPABILITIES AND STUDY THE BIOLOGY OF CANCER INFLAMMATION. THE SUBCOMMITTEE HAD A COUPLE RECOMMENDATIONS IT'S CLEAR THE CONCEPT CALLS OUT FOR MULTI DISCIPLINARY WORK WITH A FOCUS ON THE INTERACTION BETWEEN THE CANCER BIOLOGISTS AND IMAGING RESEARCHERS. AGE WE CAN ARTICULATE WORK THAT IS HYPOTHESIS GENERATING OR TESTING. AND THE RESPONSIVE CANCERS TO RFA. THE CONCEPT WAS RESTRICTED TO COLON AND BLADDER AND BREAST CANCER AND OTHERS WE RECOMMENDED THE PI BE ALLOWED TO HAVE A RESPONSE IN ANY GIVEN CANCER KIND. I'LL WELCOME MY COLLEAGUES ON THE SUBCOMMITTEE TO ADD THEIR COMMENTS. I'LL TIME IN. >> WE HAD COMMENTS AND LOOKS LIKE THEY WERE INTEGRATE AND WE'RE VERY ENTHUSIASTIC. IT'S WORTH A DISCUSSION NOW ABOUT THE RESTRICTION OF THE TUMOR TYPES. THE TUMOR TYPES SEEMED ODD AND IT'S STILL THERE AND -- >> WE'LL SWITCH IT UP IN THE WRITE UP. >> THE OTHER BOB. >> THE WHOLE PROCESS IS CENTERED IN IMMUNOLOGY SO WHY WERE THERE NOT CALLS FOR IMMUNOLOGISTS TO BE INVOLVED HERE AT ALL? >> WE ASSUME IMMUNOLOGIST AND CANCER IMMUNOBIOLOGISTS WOULD BE AN IMPORTANT COLLABORATION FOR THE INVESTIGATORS. WE DON'T HAVE RESTRICTIONS ON WHO WE'D LIKE TO COLLABORATE BUT WANT IT TO RELEVANT PEOPLE AND AT THE FOREFRONT OF WHAT PROBLEMS CAN BE ADDRESSED USING THESE TECHNOLOGIES. AND SPECIALISTS AN IMMUNOLOGISTS WOULD BE IN THE COLLABORATION AND MOST WELCOME. >> WOULD YOU LIKE US TO ADD THAT IN? >> THE OPENING STATEMENT WAS CANCER BIOLOGISTS AN IMAGING PEOPLE. >> WE WILL EXTEND THE PARTICIPATION AND THAT'S OUR INTENTION. THANK YOU SO MUCH. >> THANK YOU. I DO SUPPORT THIS. >> THANK YOU. >> YOU CAN GETS WHAT CUTS ACROSS THE DISCIPLINES. THE TYPE OF EXPERTISE WILL BE BETTER TO DEFINE IT BROADLY. >> THANK YOU >> THAT'S MUSIC TO OUR EARS. WE COULDN'T AGREE MORE. >> SURE. ANY OTHER COMMENTS? >> EILEEN. >> I WANT TO MAKE SURE IT INCLUDES CELLULAR AND THREE DIMENSIONAL RESTRICTION. IN THE CASE OF THE TUMOR MICROENVIRONMENT AND ASSESSING METABOLITES THE NEWEST TECHNOLOGY IS MASS SPECTOMETRY. I WANT IT MAKE SURE IT'S ALL IMAGI IMAGING INCLUDING 3-D RECONSTRUCTION. AND IMAGING AT SCALE AT THE MOUSE AND SUB ATOMIC IMAGING AND WHOLE MOUSE IMAGING. >> IMAGING IS IN THE EYE OF THE BEHOLDER. >> AS LONG AS IT IS PRESENTED AS SUCH. >> WE'RE RIGHT ON TIME. MAY I ASK FOR A MOTION? >> MOTION TO APPROVE. >> SECOND. >> ANY FURTHER DISCUSSION? HOW MUCH DISAPPROVE? ANY ABSTENTIONS? WE'RE RIGHT IN TIME TO WELCOME OUR GUEST. NED. >> BASED ON SOME CONVERSATIONS YESTERDAY THERE WERE SEVERAL QUESTIONS WITH TRAERNG -- TRAINING GRANTS AND I WAS UNABLE TO ANSWER THEM TO MY SATS FACE FACE -- SATISFACTION SO I ASKED OLIVER TO COME AND AT SOME FUTURE DATE IT MAY BE GOOD TO HAVE OLIVER BACK TO TALK ABOUT HIS TRAINING SINCE THAT'S OF INTEREST BUT I THOUGHT HE'D BE GOOD TO TALK ABOUT K AWARDS SO TAKE IT AWAY. >> THANK YOU FOR THE OPPORTUNITY TO BE WITH YOU. ON THE NEXT SLIDE IS A SUMMARY OF THE PORTFOLIO AND SNAPSHOT AND THERE'S INFORMATION ABOUT THE MECHANISM AND AWARD JEEZ AND THE PORTFOLIO CONSISTS OF 185 ACTIVE AWARDS WITH AN ANNUAL COMMITMENT OF CLOSE TO $39 MILLION AND FUNDING RATES AVERAGED PER YEAR OF 104 APPLICATION WINGS 36 AWARDS AND SUCCESS RATE OF 35%. BROKEN DOWN IN THE TABLE BELOW YOU CAN SEE MORE DETAIL AND YOU CAN SEE THERE IS THE LAST THREE YEARS HAVE BEEN QUITE GOOD FOR THE K08 AT NCI WITH THE SUCCESS RATES ABOVE 35% AND LAST FISCAL YEAR WE MADE 65 AWARDS. THE MECHANISM IS VIBRANT AND WE'RE EXCITED ABOUT THE GRANTS WE'RE GETTING AND THERE'S THE CONSIDERATION OF TO THE REQUIREMENT FOR RESEARCH FOR SCIENTISTS MORE ON THAT ANOTHER TIME. OND THE NEXT SLIDE IS A SIMILAR STUDY OF THE T32 MECHANISM. THE PORTFOLIO IS A COMMITMENT OF $67 MILLION PER YEAR THE APPLICATION AND FUNDING RATES ABOUT 68 A YEAR AND THE ONCOLOGY PROGRAM CAME UP YESTERDAY. IT'S TRUE WE DON'T HAVE A LOT OF T32s FOCUSSED ON ONCOLOGY AND I LOOK FORWARD TO ENGAGING FURTHER. WE REMOVED THE RETIREMENT OF PRE DOCS TO POST DOCS AND HOPING TO HAVE MORE SUBMISSIONS FROM THE COMMUNITY. THE MECHANISMS IN TRAINING AND EDUCATION ENJOY A ROBUST SUCCESS RATES. I WANTED TO GIVE YOU AN IDEA OF WHAT WE'RE INVESTING IN AND YOU SEE WE INVEST IN A LOT OF FOLKS AT THE PRE DOCS AND POST-DOCS AND EDUCATE, WELL, WE SUPPORT EDUCATIONAL EVENTS AND NEXT SLIDE RECENT HIGHLIGHTS WE RECENTLY LAUNCHED AT THE NASDAQ CONSORTIUM AND K COMPRESSION CAME UP BRIEFLY YESTERDAY. THAT'S A MECHANISM WE HAD LEFT BUT DECIDED TO REJOIN BECAUSE THE FOCUS WITH ENGINEERING BACKGROUNDS WERE NOT DOING WELL IN THE K99 MICK NIXES AND WE ARE BACK AND RENEWED OTHER MECHANISMS. I MENTIONED T32 AND K08 AND WE WORKED WITH THE COMMUNITY TO ENHANCE THAT MECHANISM BY GIVING THEM FUNDS TO CONVENE WHEN THAT BECOMES POSSIBLE AGAIN AND LAST SLIDE IS A SCHEMATIC OF OUR PORTFOLIO AND THE K25 AGAIN AND I LOOK FORWARD TO QUESTIONS AND COMMENTS AND FURTHER DIALOGUE AT SOME TIME IN THE FUTURE. THANK YOU. COULD YOU TALK ABOUT THE K12 POPULARITY. >> IT'S VERY POPULAR. THE ASK RATE IS HIGH. WE'RE ENCOURAGING FURTHER MECHANISMS BUT THERE'S A TREMENDOUS ADVANTAGE AND WE WELCOME FURTHER APPLICATIONS. THE SUCCESS RATE IS 65% OVER THE LAST FIVE YEARS. THERE'S ROOM FOR MORE COMPETITION. >> THANK YOU, THIS IS BUILDING OUR WORKFORCE CAPACITY THROUGH YOUNG SCIENTISTS AND IF YOU CAN SHARE IT THAT WOULD BE GREAT. THANK YOU. >> ONE OF THE QUESTIONS I WOULD HAVE AS YOU THINK ABOUT IT IS THERE'S ABOUT 100 CENTERS AND YOU'RE GETTING ABOUT 100 K08 APPLICATIONS PER YEAR. DO YOUIS THIS THE BAR IS BEING SET TOO HIGH AND WE'RE ASKING TOO MUCH AND NOT GETTING MORE APPLICATIONS IN ORDER TO AND I DON'T KNOW IF BOB OR OTHERS MAY COMMENT >> THAT'S A MECHANISM THAT HAS THE POTENTIAL TO GROW FURTHER. >> HIS COMMENT IS IMPORTANT BECAUSE WHERE PHARMA IS NEAR MAYBE BOB CAN BACK ME UP LEAKAGE IS HIGH COMING TO THE POINT WHERE THEY'D BE ELIGIBLE AND THEY'RE RECRUITED AWAY. IT'S ANOTHER CHALLENGE OF KEEPING PEOPLE IN ACADEMIC MEDICINE. IS THAT A CONSIDERATION OF SOMETHING TO LOOK AT? >> CERTAINLY. ONE THING I'D BE INTERESTED IN LOOKING AT IS WHAT WE'VE BEEN DOING IS ING TRANSITION AWARDS THAT IDENTIFY PROMISING INDIVIDUALS EARLY ON AND LAUNCH THEM QUICKLY THROUGH THE TRAINING TO THEIR INDEPENDENCE. WE DON'T HAVE THAT FOR CLINICIAN SCIENTISTS AND THAT IS SOMETHING WE CAN LOOK AT. >> THE K IS IT -- K12 AWARD IS A NICE INSTITUTIONAL AWARD CHALLENGED BY THE ISSUE OF PEOPLE GOING SOMEWHERE ELSE IT'S A POT OF FUNDS FOR THOSE INDIVIDUALS ONE CAN USE FOR JUST THAT PURPOSE AND THE SUCCESS RATES ARE 65%. AND WE'RE TRYING TO ADD MORE VALUE TO THE 612 FOLKS AS WELL. >> I HAVE A QUESTION ON THE K07s. THEY HAVE BEEN INCREDIBLE AWARDS FOR POPULATION SIGN TIFS. THERE'S NO OPPORTUNITY THE K08s ARE HARD FOR POPULATION SCIENCE AND NOT SURE IF YOU'RE CONSIDERING BRINGING THE K07 BACK AND I WAS A RECIPIENT WAY BACK CHEN -- WHEN AS OTHER COLLEAGUES AND THEY'RE GREAT AWARDS AND HOPING YOU'LL CONSIDER BRINGING IT BACK OR BUDGET TOGETHER A COMMITTEE TO SEE WHY WE DON'T HAVE IT ANYMORE AND HOW OTHER POPULATION SCIENTIST CANS ADVANCE THEIR CAREERS. >> THE BSA TOLD US OUR OFFERINGS WERE TOO COMPLEX AND WE SHOULD STREAMLINE THEM AND MY PREDECESSOR SPENT TIME DOING THE K COMPRESSION AND I AGREE WE NOTICED AND WHY THE K35 IS BACK I DON'T WANT TO UNDO EVERYTHING JONATHAN DID. I'M HERE TO ENGAGE WITH YOU ON THAT. >> THANK YOU. >> THE RETENTION RATE SET THE PROGRAM TO BE A NICE METHOD DOWN THE ROAD AND HAVE DONE A GREAT JOB ON THIS. AND THE DATA HAD A STRONG RECEPTOR AND KEEPING PEOPLE IN SCIENCE. >> THANK YOU. >> OLIVER IS IT TOO LATE TO SAY WELCOME TO THE NCI. >> NEVER. THANK YOU. >> THANK YOU, OLIVER. I KNOW IT WAS SHORT NOTICE BUT VERY HELPFUL. >> THANK YOU, NED FOR ORGANIZING IT. IT THINK IT WAS HELPFUL. SO ARE WE HAVING A 10-MINUTE BREAK, PAULETTE. THE NEXT CONCEPT IS AN EPSTEIN BAR VIRUS EBV AND NON-HODGKIN'S LYMPHOMA AND DR. READ-CONNOLE IS PRESENTING. >> THANK YOU FOR THE OPPORTUNITY TO PRESENT THE NEW PAR VARIOUS. >> DR. SHANNON WHITE AND ANDERSON FOR THEIR HELPFUL AND THOUGHTFUL SUGGESTIONS. I HAVE INCORPORATED THEIR SUGGESTIONS INTO THE SLIDES OR THEY'LL BE VERBALLY EXPRESSED DURING MY ORAL PRESENTATION. THE IDEA FOR THE PURPOSE OF THE PAR IS TO FOCUS ON THE ROLE OF EPSTEIN BAR VIRUS INFECTION ON NON-HODGKIN'S LYMPHOMA AND HODGKIN'S DISEASE WITH OR WITHOUT AN HIV INFECTION. WE HOPE IT WILL EXAMINE HOW EVB PROMOTES NON-HODGKIN'S LYMPHOMA OR THE DISEASE PROGRESSION AND RESULTING DISEASE SEQUELAE AND WILL PROVIDE INSIGHT INTO MECHANISTIC DIFFERENCES OF EVB INFECTION AND LYMPHOMEGENESIS BETWEEN HIV POSITIVE AND NEGATIVE PERSONS. FROM MY OWN PAST EXPERIENCE AS AN NCI POST-DOC IN THE CLINICAL CENTER I SAW HOW DREADFULLY ILL THESE PATIENTS ARE SO I'M ENTHUSIASTIC ABOUT PRESENTING THIS TO YOU. IN THE WAY OF BACKGROUND THE CHARACTERISTICS OF BOTH NON-HODGKIN'S LYMPHOMA AND HODGKIN'S DISEASE ARE DIFFERENT BETWEEN THE HIV POSITIVE POPULATION WITH EPSTEIN BAR VIRUS CO-INFECTION ARE VERY DIFFERENT FROM THOSE ONLY EPSTEIN BAR VIRUS GROUP. ABOUT 40% OF ALL EVB POSITIVE CASES NON-HODGKIN'S LYMPHOMA DEVELOP IN PERSONS LIVING WITH HIV. AND THE LYMPHOMA TYPES ARE DIFFUSE LARGE B CELL LYMPHOMAS OR CENTRAL NERVOUS SYSTEM LYMPHOMAS WHICH ARE ABOUT 100% EVB POSITIVE. AND IT'S FOUND APPROXIMATELY 50% OF NON HODGKIN'S LYMPHOMAS ARE [INDISCERNIBLE] AND 13% ARE EVB POSITIVE LYMPHOMAS. DLBCL IS NOT EVB POSITIVE AND THERE'S FEW CNS LYMPHOMAS. THE AGE OF ONSET IS MUCH OLDER IN THE RANGE OF 64 TO 74 YEARS OF AGE. IF WE COMPARE AND CONTRAST HODGKIN'S DISEASE WITH EVB WITHOUT AN HIV INFECTION THERE'S MIXED CELLULARITY AND THE CELLS ARE EVB INFECTED AND UNIQUE FEATURES OF THE TUMOR MICROENVIRONMENT RELATING TO THE IMMUNE INFILTRATES. IN CONTRAST, HODGKIN'S DISEASE AND EPSTEIN BAR VIRUS POSITIVE PATIENTS THERE ARE MORE FREQUENT SYSTEMS INCLUDING NIGHT SWEATS, FEVERS, PERHAPS ORGAN INVOLVEMENT AND WEIGHT LOSS AND THE AGE OF ONSET IS ALSO DIFFERENT EITHER ADOLESCENT HODGKIN HODGKIN'S DISEASE IN YOUNGER ADULTS OR ADULTS OVER 65 YEARS OF AGE. THESE ARE NOT ALL ABSOLUTE SUGGESTIONS BUT OUR SUGGESTIONS WE THINK CAN EXPLORE FURTHER DEVELOPMENT FOR BOTH NON-HODGKIN'S LYMPHOMA OR HODGKIN'S DISEASE ARE EVB POSITIVE AND/OR HIV POSITIVE -- SORRY, HIV NEGATIVE PATIENTS. ONE IS HOW HIV AFFECTS ALONE OR IN ASSOCIATION WITH EVB AND ESTABLISH THE ENVIRONMENT FOR THE DEVELOPMENT OF HOCK KINS DISEASE OR NON-HODGKIN'S LYMPHOMA AND HOW AND WHY DOES HIV INFECTION AND EBV REACTIVATION HAS AN IMPACT ON RESPONSES TO TREATMENT THAT DIFFER FROM HIV NEGATIVE PATIENTS AND ARE THERE POPULATION DIFFERENCES IN THE DEVELOPMENT OF NON-HODGKIN'S LYMPHOMA OR HODGKIN'S DISEASE AND DO EXOGENOUS OR ENDOGENOUS FACTORS CONTRIBUTE TO HODGKIN'S LYMPHOMA OR INFECTIONS WITH EVB. A HELPFUL SUGGESTION FOR REVIEWERS FOR THE CONCEPT CONCERNS THANKING OF SPECIMENS AND I WILL PUT IN TO THE GUIDE NOTICE IF APPROVED WE WILL DIRECT INVESTIGATORS IF AVAILABLE TO THE CANCER RESOURCE WHICH IS ALSO FUNDED BY THE NCI AND WE HAVE DONE THIS ON AN RFA RELEASED LAST YEAR. IF WE TURN TO RESEARCH SUGGESTION FOR LYMPHOMA OR HODGKIN'S DISEASE WE CAN THINK OF MECHANISTIC STUDIES EXPLORING HOW EVB INFECTION CAUSES HODGKIN'S LYMPHOMA OR DISEASE AND WHY DIFFERENT LATENCY PROGRAMS ARE SELECTED AND HOW IT AFFECT THE DEVELOPMENT OF HD. EXPLORE POPULATION AND SEX DIFFERENCES IN THE DEVELOPMENT AND RESPONSES TO THERAPY DEVELOPED CELL, TISSUE OR SMALL ANIMAL MODELS TO STUDY EVB AND HODGKIN'S LYMPHOMA FOR HODGKIN'S DISEASE AND DEVELOP PREVENTIVE OR THERAPEUTIC STRATEGIES FOR EVB RELATED NON-HODGKIN'S LYMPHOMA OR HODGKIN'S DISEASE. AS A JUSTIFICATION FOR THE USE OF THE PAR, THIS IS A NECESSARY MECHANISM TO INCENTIVIZE INVESTIGATORS TO PROPOSE HIGH RISK PROJECT TO ADDRESS NON-HODGKIN'S LYMPHOMA WITH AND WITHOUT AN HIV INFECTION AND ALSO HODGKIN'S DISEASE IN BOTH CASES. APPLICATIONS WILL BE REVIEWED BY A PANEL OF AREA EXPERTS CONVENED BY THE NCI DIVISION OF EXTRAMURAL ACTIVITIES AND WE FEEL THIS WILL REQUIRE EXPERTISE TO REVIEW THE ENTIRE GROUP RECEIVED IN A SINGLE REVIEW MEETING FIRST THE MECHANISMS RO1 AND 21s AND RECEIPT DATES WE HOPE TO HAVE ONE RECEIPT DATE PER YEAR FOR ALL APPLICATIONS FOR THREE YEARS APPROXIMATELY AUGUST 2021, AUGUST 2022 AND AUGUST 2023. THE BUDGET SOURCE WILL BE THE RPG AND THE TOTAL WE ESTIMATE IS $2 MILLION PER YEAR AND I'LL ADD THAT THE OFFICE OF AIDS RESEARCH HAS AGREED TO COST SHARE OR SUPPORT THE AIDS RELATED APPLICATIONS. THE TOTAL BUDGET FOR THE ENTIRE PROJECT PERIOD OF UP TO FIVE YEARS WOULD BE $18 MILLION TOTAL. NOW LET'S LOOK AT THE PORTFOLIO ANALYSIS THIS IS THE PORTFOLIO ANALYSIS SOLELY OF THE CANCER GRANTS FROM THAT HAVE FUNDED IN FY20 AND FY21. DOING A SEARCH FOR EBB SEED VIRAL VIRUS IN CANCER IT LED TO 24 APPLICATIONS CURRENTLY FUNDED AND IF WE LOOK THAT'S SUB GROUP OF THOSE APPLICATIONS WE SEE 18 ARE RELATED TO EVB MOLECULAR ST STUDIES AND TO THE RIGHT YOU SEE 10 APPLICATIONS PART OF THE 24. OUR RESPONSE TO AIDS RELATED RFAs. OF THOSE 10 THREE HAVE RFA FUNDED APPLICATIONS INTO NON-HODGKIN'S LYMPHOMA. NONE WERE SPIFK FOR HODGKIN'S -- SPECIFIC FOR HODGKIN'S DISEASE. ALSO I WAS ASKED WHAT DID THE REST OF THE NIH PORTFOLIO LOOK LIKE? FIRST LOOKING FOR EVB AND LYMPHOMAS IN OTHER ICs I FOUND TWO APPLICATIONS. ONE UG1 ON AGE RELATED LYMPHOMA AND ONE AIFDS RELATED APPLICATION FROM NINDS. I ALSO LOOKED FOR STUDIES ON EPSTEIN BAR VIRUS AS YOU MIGHT EXPECT I FOUND 17 APPLICATIONS THAT WERE CURRENTLY FUNDED AND OF THESE THE MAJORITY ARE FROM THE NINDS AND DENTAL INSTITUTE AND THE REMAINING ONES REPRESENTED BY AGING GENERAL MEDICAL SCIENCES AND KIDNEY DISEASES AND E.S. ENVIRONMENTAL SCIENCES. THE PORTFOLIO IN EVB RELATED STUDIES FOR NIH IS NOT VERY LARGE FOR SOMETHING FOR A VIRUS THAT'S BEEN KNOWN FOR 50 YEARS AND I WOULD ALSO SAY THERE ARE INTERMURAL PROJECTS ON EVB AND MANY OF THESE ARE JOINTLY FUNDED BETWEEN NCI AND NIAID LOOKING INTO DEVELOPING AN EVB VACCINE. AND I'M HAPPY TO TAKE QUESTIONS. THANK YOU FOR YOUR ATTENTION. >> THANK YOU. >> I THINK EILEEN AND KEVIN AND I MET AND BROUGHT UP SOME OF THE ISSUES THAT BETSY JUST SO NICELY ADDRESSED. THE ISSUE OF THE PORTFOLIO SURGE AND THE ISSUE OF THE KINDS OF GRANTS THAT MIGHT BE SUPPORTED RO1 AND R21. I THINK BETSY DID A SUPER JOB. SHE TOLD US THE HISTORY OF THIS. THERE WAS A SUBCOMMITTEE THAT DISCUSSED THIS AS A PRIORITY AND THEY WROTE A COMPREHENSIVE PAR AND WE STRONGLY ENDORSED IT. THE IDEA YOU CAN LEARN FROM EVB POSITIVE VERSUS NEGATIVE HIV INFECTED VERSUS NOT AND HODGKIN'S VERSUS NON-HODGKIN'S LYMPHOMA ARE WONDERFUL SETTINGS IN WHICH TO LEARN MORE ABOUT THE BIOLOGY AND EPIDEMIOLOGY WE'VE BEEN TALKING ABOUT THE TUMOR MICROENVIRONMENT. THERE'S PROBABLY NOT A BETTER OPPORTUNITY TO STUDY THAT AND IMMUNE STUDIES WOULD BE OF GREAT INTEREST IN THE SETTING. AND BETSY ADDRESSED THE IDEA WHERE THE SAMPLES CAN COME FROM WHAT ABOUT OTHER PROGRAMS AND THE IDEA TO DEPOSIT IN AIDS AND SPECIMEN CANCER RESOURCE IS A WONDERFUL IDEA THAT WILL FAST FORWARD PROGRESS BY SHARING RESOURCES. I THINK WE STRONGLY ENDORSED AND THE FINAL THING I'LL SAY IS THE IDEA OF A SINGLE REVIEW PANEL SEEMED APPROPRIATE GIVEN THE SPECIFICITY AND BREADTH OF THE KINDS OF STUDIES YOU MIGHT RECEIVE HERE. THE I'D YOU CAN COST SHARE IS ALWAYS A GOOD ONE. HOPEFULLY THE OFFICE OF RAIDS RESEARCH WILL -- AIDS RESEARCH WILL CONTRIBUTE WHEN IT'S TIME TO FUND THE GRANTS. THANK YOU, WONDERFUL JOB. >> THANK YOU. >> THE PROGRAM WAS RESPONSIVE AND I'D BE INTERESTED IN ANY COMMENTS YOU MIGHT HAVE. >> KEN CAPTURED EVERYTHING QUITE WELL. I HAVE NOTHING TO ADD. >> OKAY. ANY QUESTIONS FROM BOARD MEMBERS? IF NONE I BELIEVE WE'RE READY TO MOVE FORWARD WITH VOTING. I WOULD LIKE TO ASK FOR A MOTION. >> ANY DISCUSSION? HOW MANY DISAPPROVE? ANY ABSTENTIONS? >> THIS IS A LITTLE NEW FOR US. IT'S BEEN EASIER IN THE PAST TO FUND HIV GRANTS THAN EVB HIV GRANTS AND PROBABLY WONDERED WHY AND HAD TO DO WITH THE POSTURE REGARDING FUNDING RESEARCH THAT WASN'T CLEARLY A BENEFIT TO PATIENTS WITH HIV. THERE WAS CONCERN THE I.C.s WOULD USE AIDS RESEARCH MONEY FOR NON-HIV RELATED DISEASE AND HAD CONVERSATIONS ABOUT THIS AND NOW WE HAVE A NICE AGREEMENT TO DO COST SHARING WHEN WE SEARCH PROPOSALS RELATED TO THE BENEFIT OF PATIENTS WITH HIV. IT'S SOMETHING WE WORKED ON A LOT AND PLEASED TO SEE IT GO FORWARD AND IMPORTANT WE CAN FUND THINGS LIKE EVB RESEARCH IN PATIENTS WITH OR WITHOUT AIDESES. >> WE SHOULD SEE MORE OF THIS. >> THANK YOU, NED. >> WE'LL MOVE TO THE NEXT CONCEPT THE RE-ISH SUE OF THE NCI CANCER SYSTEMS BIOLOGY CONSORTIUM. THE SUBCOMMITTEE CONCURRED WITH RE-ISHAN RE-ISHANCE -- ISSUANCE AND THE SUBCOMMITTEES THE REVIEWED IT WERE MICHAEL AND TIM LACY AND ONE PERSON HAD TOO STEP OUT >> THANK YOU FOR THE OPPORTUNITY TO SPEAK TO YOU AND THANK YOU FOR THE SUBCOMMITTEE THAT GAVE HELPFUL COMMENTS ON THE CONSORTIUM WE SUPPORTED THIS TO HAVE INVESTIGATOR INITIATED BIOLOGY USING SYSTEM BIOLOGY APPROACHES AND IT'S THE EXPLICIT INTEGRATION OF EXPLICIT BIOLOGY AND MATHEMATICAL MODELLING TO PRE BUILD PREDICTIVE MODELS TO BE TEST ORDER VALIDATED IN CANCER RELEVANT CONTEXT. AND IT CONSISTS OF 37 AWARDS. 13, U54s CENTERS AND ONE WITH THE NETWORK AND STE UR1 PROJECTS. AND THE UR1s ARE NOT BEING REQUESTED TO BE RE-ISSUED AT THE TIME. AND THERE'S CONTEXT P AV AND THERE'S SCIENTIFIC WORKING GROUPS. THERE'S AN ANNUAL MEETING AND THEIR FOCUS ON OUTREACH WHICH I'LL TALK MORE ABOUT LATER AND IS A REQUIRED COMPONENT OF OUR U54 CENTERS. THERE'S THREE MAIN GOALS. THE FIRST AND MOST IMPORTANT GOAL IS THE UNDERSTANDING OF MECHANISMS THAT UNDER LIE PROCESSES. THIS SHOWS 500 PUBLICATIONS FROM 2017 TO MID 2020 AND ORGANIZED BY THE ABSTRACT OF THE PAPERS TO ILLUSTRATE THE BREADTH OF RESEARCH. THERE'S A STRONG PORTFOLIO THAT LOOK AT THE DEVELOPMENT OF RESISTANCE ACROSS A VARIETY OF CANCERS. THERE'S ALSO A NUMBER OF INVESTIGATORS INTERESTED IN DESCRIBING AND UNDERSTANDING TUMOR HETEROGENEITY AND EVOLUTION AS IT RELATES TO METASTASIS. THERE'S A STRONG CONTINGENT OF INVESTIGATORS USING SINGLE CELL STUDIES AND DEVELOPING THE TYPES OF COMPUTATIONAL METHODS REQUIRED TO FACILITATE DATA. WE ARE LOOK AT TUMOR INTERACTIONS AND TUMOR IMMUNE CELL AND STROMAL CELL INTERACTIONS AND THERE'S ALSO A STRONG REPRESENTATION OF EXPERIMENTAL METHODS ACROSS THE CONSORTIUM. THE SECOND IS TO LOOK AT APPROACHES AND WE DO THIS THROUGH WORK SHOPS AND BRING IN NEW INVESTIGATORS TO INTERFACE WITH OUR RESEARCH SYSTEMS BIOLOGY MEMBERS WE ALSO SHARE THE RESOURCES AND TOOLS GENERATED BY THE ONCOLOGY NETWORK WITH THE PORTAL. AND WE HAVE A VARIETY OF OUTREACH ACTIVITIES AND SUPPORT THE TRADING OF NEW CANCER SYSTEMS BIOLOGIST. WE DO THAT PROGRAMMATICALLY WITH A RESEARCH PROGRAM THAT GIVES THE OPPORTUNITY FOR STUDENTS WHO OTHERWISE WOULD NOT HAVE THE OPPORTUNITY TO DO SYSTEMS BIOLOGY RESEARCH AND PROVIDE THE OPPORTUNITIES THROUGH THE RESEARCH CENTERS AND PROJECTS. WE ALSO TRACK TRAINEES OF THE 86 GRADUATE STUDENTS THAT MOVED ON IN THEIR POSITION BETWEEN 2017 AND 2020 AND THE MAJORITY STAY WITHIN AN ACADEMIC TRACK AND HAVE 25 ASSISTANT PROFESSORS THAT HAVE GRADUATED IN CANCER SYSTEMS BIOLOGY. AND WE AND WE LOOKED AT PROGRAM SUCCESSES AND OPPORTUNITIES FOR THE FUTURE AND MAKE WE'RE SHARING DATA SETS AND TOOLS IN A FAIR WAY. AND THE U54 RESEARCH CENTERS WILL LOOK SIMILAR TO HOW THEY LOOK NOW WITH REGARDS TO STRUCTURE AND EACH RESEARCH CENTER WILL BE RALLIED AROUND A RESEARCH THEME UP TO THREE PROJECTS WITHIN THE CENTERS SPEAK TO THAT RESEARCH THEME OF EACH CENTER CAN HAVE UP TO TWO SHARED RESEARCH CORES AND WILL MAINTAIN THE REQUIRED OUTREACH CORE. AND A PROJECT FUND WAS INCLUDED IN THE FIRST ROUND AND WE'LL MAINTAIN THAT IN THE SECOND ROUND AND SUGGEST STRONGLY THAT INVESTIGATORS USE THOSE FUNDS TO INCREASE THE DIVERSITY OF THE RESEARCH TEAMS AND ALSO MOVE THEIR FINDINGS TOWARDS THE CLINIC. WE PLAN TO INTRODUCE A NEW FUND OF $75,000 DIRECT COST TO SUPPORT CROSS CONSORTIUM COLLABORATIONS NOT JUST WITHIN THE CSBC BUT WITH OTHER INVESTIGATORS WHO ARE INTERESTED IN SYSTEMS BIOLOGY. IT WILL MAKE IT A REQUIREMENT TO SHARE YOUR DATA THROUGH THE NCI DATA COMMENTS AND TO WORK WITH U24 TO INCREASE THE INTEROPERABILITY OF OUR DATA SETS. I'M NOT GOING TO READ THE LIST INCLUDED IN THE CON SEPS BUT IT'S CLEAR -- CONCEPTS BUT THERE'S A VARIETY OF BASIC CANCER RESEARCH QUESTION COULD BE BEST ADDRESSED THROUGH A SYSTEMS BIOLOGY TYPE EFFORT. NEXT THE REISSUANCE OF THE U24. WE'D LIKE TO EXPAND THE COORDINATING CENTER TO COORDINATE FIVE PROGRAMS WITHIN THE DIVISION OF CANCER BIOLOGY NOT ONLY THE CSBC AND PHYSICAL SCIENCE ONCOLOGY BUT THE COLLABORATIVE AND THE CANCER CELL BIOLOGY RESOURCE. WE THINK IT WILL HELP TO BREAK DOWN SILOS BETWEEN OUR PROGRAMS AND MAKE BETTER TIES BETWEEN THE INVESTIGATORS AND LET THE INVESTIGATORS TAKE ADVANTAGE OF THE UNIQUE RESOURCES GENERATED BY EACH ONE OF THE PROGRAMS. THE COORDINATING CENTER WILL HAVE A THREE-HUB MODEL IN WHICH THE FIRST HUB WILL BE CHARGED WITH HELPING TO COORDINATE THE COLLABORATIONS THE PROGRAMS. THE SECOND WILL BE REQUIRED TO HELP INVESTIGATORS DEPOSIT WELL LABELLED DATA IN THE COMMENTS AND WE'RE NOT ASKING THIS COORDINATING CENTER TO DUPLICATE THE RESOURCES ALREADY AVAILABLE THROUGH THE DATA COMMENTS BUT RATHER HELP OUR INVESTIGATORS TAKE ADVANTAGE OF THOSE RESOURCES. FINALLY THE COMPUTATIONAL TOOLS AND RESOURCES GENERATED BY THE CSBC AND I'D LIKE TO PAUSE AND THANK THE SUBCOMMITTEE FOR SUGGESTING WE OPEN UP THE LIMITED COMPETITION TO AN OPEN COMPETITION AND WE AGREE IT WILL ENCOURAGE PARTICIPATION AND CONTINUE TO EVALUATE BASED ON THE ORIGINAL THREE GOALS I OUTLINED EARLIER IN THE PRESENTATION. ALSO ADD SOME ADDITIONAL ASPECTED TO WHAT WE EXPECT AS -- ASPECT OF A MEASURE OF SUCCESS. IN SUPPORT OF GOAL TWO OF SUPPORTING A BROAD APPLICATION OF SYSTEMS BIOLOGY NOT ONLY WILL WE COUNT THE NEW COLLABORATIONS FORMS WE'D LIKE TO INCREASE THE DIVERSITY OF THE CANCER SYSTEMS BIOLOGY FIELD ITSELF. IN SUMMARY, WE'RE REQUESTING REISHAN REISHANCE -- ISSUANCE TO SUPPORT THE U54 AND BIOLOGY PROGRAMS AND THE FIRST YEAR BUDGET WILL BE $14.85 MILLION. FINALLY, I'D LIKE TO SPEND ONE MINUTE TALKING ABOUT THE DISCUSSION WITH OUR REVIEWERS. A A AND WE ENGAGED IN EXTERNAL EXPERT PANEL THAT FOUND THE CSBC WAS HAVING EYE SIGNIFICANT IMPACT ON THE FIELD OF SYSTEMS BIOLOGY THROUGH THE INTRODUCTION OF THE APPROACHES. AND THE ANALYSIS SUPPORTED THE PANEL. THERE ARE A VARIETY OF DIFFERENT CHARACTERISTICS OF OUR AWARDEES THAT COULD BE PROVIDED. OF THE 70 MPIs IN OUR AWARD, NINE WERE EITHER EARLY STAGE OR INVESTIGATORS OR NEW INVESTIGATORS AT THE TIME OF AWARD. WE CONTINUE TO HAVE A LARGE COMMUNITY OF EARLY STAGE INVESTIGATORS INVOLVED IN THE PROGRAM ALL THE AWARDS GO TO RESEARCH INSTITUTIONS AND HOW IT'S AFFECTED THE PORTFOLIO? WE LOOKED AT THE OF PUBLICATIONS CITED AND FOUND OVER 2100 GRANT APPLICATIONS BETWEEN 2017 CITED CSBC WORK AND THE VAST MAJORITY COME FROM INVESTIGATORS OUTSIDE THE CSBC. WE KNOW OTHER COLLABORATIVE PROJECTS IN THE CSBC HAVE RESULT IN THE FUNDING AND RO1s AND THERE ARE OTHER QUESTIONS WE ALSO DISCUSSED WITH OUR BSA REVIEWERS I HOPEFULLY WAS ABLE TO IN COP RATE IN THE PRESENTATION -- INCORPORATE AND I'D LIKE TO THANK EVERYONE FOR YOUR ATTENTION AND I'D BE HAPPY TO TAKE ANY QUESTIONS. >> THANK YOU. I'D LIKE TO INVITE MIKE TOLL TO START THE DISCUSSION. THAT WAS RESPONSIVE. WE APPRECIATE THE COMPLETENESS OF THE CONCEPT THE SUBCOMMITTEE FELT THE POTENTIAL FOR SUCCESSES GIVEN THE SHORT PERIOD OF OPERATIONS WE THINK SHARING OF TOOLS AND KNOWLEDGE IS AN AREA HIGHLIGHTED IN THE EXPERT PANEL AND WHERE THE FOCUS OF OPENING OF THIS TO COMPETITION WAS RECOGNIZED AND THE SUBCOMMITTEE OF DATA AND RESOURCES BUT GETTING THE KNOWLEDGE IS FOCUSSED ON THE EXPANSION OF THIS TO THE FIVE INTERSECTING PROGRAM. IT HAS THE POTENTIAL TO INFORM CANCER TREATMENT AND PREVENTION OF PUBLICATIONS AND IMPACT HOWEVER, TO MAKE THE OPTIMAL IMPACT WE WANTED TO HAVE BETTER COORDINATION AND SERVE THE INTEREST IN THE PROGRAMS. THE INCREASED COLLABORATION AND OUTREACH TO BIOLOGICAL RESEARCHERS TO HUMAN IMPACT IS CRITICAL AND WE ADVOCATE WE THINK CAREFULLY ABOUT THAT AND SELECT IT CLEARLY TO MAKE SURE IT ACHIEVE THE STATED GOALS AND THE GENERATION IS DIFFERENT FOR JUST SHARING TOOLS AND DATA AND HAS AN ADDITIONAL CHALLENGE AND FEEL IT'S IMPORTANT TO SPEAK LOUDLY WITH THE CHOICE OF THE OUTREACH. I'LL OPEN IT UP TO JAMES BECAUSE DAVID'S NOT HERE FOR COMMENTS. >> THANK YOU. YOU SUMMARIZED IT WELL AND ONE OTHER ADDITIONAL POINT AND THANK YOU FOR THE PRESENTATION. YOU MENTIONED OCTOBER 20 EXPERT PANEL AND ON SLIDE 6 YOU MENTIONED SOME ACTIONS. I WANT TO POINT OUT ONE OTHER THING I'D LIKE TO ASK THE NCI TO KEEP IN ITS MIND AND BSA AS WELL THE COMMENT IN THE REPORT THE CSBC MAY NOT BE FULLY INCLUSIVE BECAUSE THE STRUCTURE CARRIES THE RISK THE FUNCTION OF SMALL IVE -- COGNITIVELY INFORM THE FIELD AND HAVE ORTHODOXYS. THE COMMENTS ON STRUCTURAL RACISM THIS IS THE SCENARIO WHERE IT CAN REAR ITS HEAD. I THINK IT'S A GOOD OPPORTUNITY AS WE GO IN THE NEXT PHASE TO GET OUT IN FRONT OF THAT AND BE MORE PROACTIVE. I WANT TO PARTICULARLY RECOGNIZE THE EFFORTS TO MAKE THAT COORDINATING CENTER EFFECTIVE WOULD BE PARTICULARLY GOOD AND I'LL STOP THERE. THANKS. >> THIS WOULD BE WITH THE NUMBER OF PEOPLE WE BRING IN THE NCI SO THANKS, JIM. >> OKAY. ARE THERE ANY QUESTIONS TO SHANNON OR TO THE REVIEWER FROM THE REVIEWERS FROM THE BOARD? >> CAN I ASK ABOUT ADDED VALUE AND IN THE SLIDE ABOUT SUBJECTIVE OF THE INVESTIGATORS ARE PURSUING SINGLE CELL SEQUENCING SOUNDS PRETTY ROUTINE IN MANY CENTERS NOW AND MORE SUPPORTED BY R10 -- ROCH -- R01s AND ASKED HOW THEY'RE APPLIED IN THE CANCER COMMUNITY. THERE'S TOOLS AND KNOWLEDGE PROCESSES. IT'S NOT JUST METHODOLOGY THAT'S IMPLIED AND IMPORTANT AND THERE'S NOT REALLY A GOOD PLACE TO SHARE THOSE IN THE NCI SUPERSTRUCTURE. THE TOOLS, MODELS AND METHODOLOGIES AND I SEE THAT VALUE CLEARLY BUT THAT IS. >> THEY'RE GENERATING THE TOOLS AND KNOWLEDGE PEOPLE IN RO ISs GO ON TO USE. MODELLING SINGLE CELL DATA IS A NEW AND CHALLENGING ASPECT AND WE HAVE SEVERAL PEOPLE IN OUR CONSORTIUM THINKING BEYOND CELL CATALOGING TO UNDERSTAND HOW THE CELLS ARE INTERACTING AND HOW TO MAKE PREDICTS ABOUT BEHAVIORS. I THINK THAT IS WHERE YOU CAN BRING A LOT OF VALUE. >> THESE ARE NOVEL TECHNIQUES. DESPITE THE RELATIVELY LOW DIAMETER AND LETTING THE DIFFERENT TOOLS INTERACT. AND I APPRECIATE THAT PART. ANY OTHER QUESTIONS OR COMMENTS? IF THERE'S NONE, I THINK ANYBODY SAY ANYTHING? OKAY. SO WE ARE GOING TO MOVE TO -- I THINK IT WAS A RE-ISSUANCE. I WILL IS ASK FOR A MOTION. >> MOTION TO APPROVE. >> I'LL SECOND THAT. >> MOTION TO CONCUR, RIGHT? OKAY. SECOND? ANYONE NOT CONCUR? ANY ABSTENTIONS. >> OKAY. >> THERE'S THE. >> OKAY. THE FINAL CONCEPT FOR TODAY IS A NEW RFB. SPIR CONTRACT TOPICS. MS. NARAYANAN WILL FRIEND. -- WILL PRESENT. >> THANK YOU FOR YOUR PATIENCE FOR THIS LAST PRESENTATION ON SBIRs AND CONTRACTS SOLICITATION TOPIC. THE BUDGET IS CONGRESSIONALLY SET ASIDE AND WE FUND PROMISING START-UPS BY SBIR GRANTS WHICH ARE INVESTIGATOR INITIATED AND CONTRACTS WHERE TOPICS ARE DEFINED BY THE NCI. THESE ARE PART OF A CONSOLIDATION AND SBIR CONTRIBUTES 10 TO 12 NEW TOPICS BETWEEN 15% TO 20% OF OUR BUDGET AND WE SPENT 14% OF OUR BUDGET ON CONTRACTS WHY DO WITH USE CONTRACT AS A VEHICLE AND IT'S ONE WAY TO GET MORE IN OUR PORTFOLIO AND SUPPORT KEY NCI PRIORITY AREAS AND PROGRAM OFFICERS ACROSS THE NCI HELP IDENTIFY SPECIFIC NEEDS IN THE CANCER COMMUNITY THAT WE CAN ADDRESS VIA CONTRACT. WITH USE CONTRACT TO SIMULATE AREAS WHERE PRIVATE SECTOR DOESN'T SUPPORT AND DELIVERABLE TO ENSURE COMPANIES TAKE A STREAMLINED APPROACH TO DEVELOPMENT. IN THE PAST WE USED TECHNOLOGY SUPPORT AND WE DO NOT SUPPORT TOPICS THAT ARE SUB ONLY NCI OR MUST HAVE A COMMERCIAL MARKET HOWEVER, SMALL THAT COULD BE. IDENTIFYING THE PROCESS WE SOLICIT IDEAS WITH NEW PROPOSALS ACROSS NCI SUBMITTED FROM PROGRAM DIRECTORS FROM THE DIVISIONS AND OFFICES ALL THE ONES IN RED HAVE SUBMITTED CONTRACT TOPICS IN THE PAST COUPLE YEARS. WE LEVERAGE THEIR KNOWLEDGE OF GAP AREAS IN THE PORTFOLIOS. AND THEY ATTEND CONFERENCES AND SO ON AND THEY KNOW WHAT IS EMERGING OR PART OF THE FIELD. THIS YEAR WE HAD TOPICS SUBMITTED BY THE OFFICE OF SCIENCE AND ENGINEERING LAPS. A DIVISION WITHIN THE FDA THAT SUPPORTS MEDICAL DEVICE DEVELOPMENT TOOLS. THE SBIR TEAM ASSEMBLED TWO TECHNOLOGY GROUPS TO EVALUATE THE TOPICS AND IN THE DAY LONG EVALUATIONS SUBJECT MATTER EXPERTS EVALUATE THE SUBMITTED TOPICS FOR INNOVATION AND CONCEPT AND COMMERCIAL OF THE PROPOSED CONCEPT OF THE TECHNOLOGY AND THE SIGNIFICANCE AND IMPACT ON CANCER PATIENTS PROVIDERS. THEY'RE PRIMARILY PROGRAMMED OFFICERS FROM DIFFERENT DIVISIONS AND OFFICES ACROSS NCI. REVIEWERS ALSO MAKE SURE TOPICS ARE NOT ALREADY REPRESENTED HEAVILY IN THE GRANTS PORTFOLIO AND IF THERE ARE RE-ISSUES THERE'S AN APPROPRIATE JUSTIFICATION FOR RE-ISSUING AND SUGGEST MODIFICATION TO IMPROVE THE TOPIC. BASED ON THE REVIEW, THEY PUT TECHNOLOGY SELECTED TOPICS IN FEBRUARY FOR THE APPROVAL AND LAST MONTH SEVEN TOPICS WERE PRESENTED AND APPROVED BY THE ICC MOONSHOT COMMITTEE AS BEING ALIGNED WITH MOONSHOT GOALS. THE PROCESS ENSURES NOTE ONLY THERE IS EQUAL REPRESENTATION OF TOPICS ACROSS THE NCI AND DIFFERENT TECHNOLOGY TIES WHETHER THAT'S DRUGS, DEVICES OR DIAGNOSTICS AND PRODUCTS THAT CAN BE USED ACROSS THE CANCER CARE CONTINUUM. LET ME QUICKLY GO OVER THE 16 TOPICS WE HAVE THIS YEAR. THESE TOPIC TECHNOLOGY AREAS ARE BROAD AND COVER THE ENTIRE MISSION OF THE NCI. THE BUDGET FOR EACH PHASE 1 IS $400,000 TOTAL COST FOR NINE MONTHS PROJECTS AND THE PHASE 2s ARE $2 MILLION TOTAL COST FOR TWO YEARS. COMPANIES IN MOST CASES HAVE TO APPLY FOR A PHASE 1. IT'S LISTED ON THE BOTTOM RIGHT. THE DIVISION SUBMITTED ARE PROVIDED BELOW THE TOPIC TITLE AND SBIR REPRESENTED FOR THE CONCEPT AND DO COMMERCIALIZATION ANALYSIS. I'VE INDICATED IF IT'S MOONSHOT RELEVANT OR A RE-ISSUE. WE HAVE THREE CANCER THERAPEUTIC TOPICS. THE FIRST IS DEVELOPMENT OF SIGNAL THERAPEUTIC AGENTS AND THEY HAVE UTILITY AS NEW ADJUVANT OR IN COMBINATION OR AND THE GROW IS TO SUPPORT THE DEVELOPMENT OF -- GOAL IS TO SUPPORT IN DEVELOPMENT. AND THE NEXT IS CANCER TREATMENT TECHNOLOGY FOR LOW-RESOURCE SETTINGS WITH THE GOAL OF DEVELOPING AND APPLYING AND EXISTING TECHNOLOGIES INTO SETTINGS FOR CANCER TREATMENT. THE LAST IS SYNTHETIC BIOLOGY FOR CANCER THERAPY. SYNTHETIC GENE CIRCUITS CAN BE DEVELOPED INTO EX VIVO OR IN VIVO. THE GOAL IS TO DEVELOP GENE THERAPIES AND MAKE PROGRAMS TO DISTINGUISH CANCER CELLS FROM NORMAL CELLS AND ACTIVATE EXPRESSION FROM INSIGHT TUMORS. WE HAVE THREE MEDICAL DEVICE TOPICS. THE FIRST IS DEVELOPING UNBIASSED MEDICAL BIOLOGIES AND THE LONG TERM GOAL IS THE DEVELOPMENT OF COST EFFECTIVE AND READILY DISSEMINATED MEDICAL TECHNOLOGIES DESIGNED TO REDUCE RACIAL AND ETHNIC BIAS IN THE MEDICAL CARE SYSTEM AND REDUCE DISPARITIES IN CANCER PRE CONVENIENCE AND CONTROL OUTCOMES. THE NEXT TOPIC IS ULTRA FAST DOSE RATE OR RADIATION DETECTERS AND MEASURE RADIATION DOSE LACK RESPONSE TIMES SUFFICIENT TO ADDRESS DOSE RATE AND THE GOAL OF THIS CONCEPT IS TO ADVANCE THE DEVELOPMENT AND THE APPLICATION OR THE APPLICATION OF DEVICES TO ALLOW FLOOR RADIATION THERAPY TO BE PROPERLY EVALUATED AND ULTIMATELY TRANSLATED INTO THE CLINIC. THE LAST DEVICE TOPIC IS DEVICES TO TREAT LYMPHODEMA AND INTENDED TO SUPPORT THE DEVELOPMENT OF TECHNOLOGIES THAT PREVENT, REDUCE OR ELIMINATE LYMPHODEMA FOLLOWING REMOVAL OR RADIATION OF LYMPH NODES DUE CANCER IN THE UPPER BODY. THE NEXT TOPIC IS NEW TECHNOLOGIES TO ANALYZE EXTRA CHROMOSOMAL DNA AND AIMS TO DEVELOP NEW TOOLS CRITICALLY NEEDED TO ANALYZE EXTRA CHROMOSOMAL STRUCTURE AND REGULATION. TOOLS AND TECHNOLOGIES DEVELOPED UNDER THE TOPIC ARE EXPECTED TO UNABLE IMPORTANT BASIC RESEARCH ON EXTRA CHROMOSOMAL DNA AND THIS TOPIC WAS IDENTIFIED AS A 2020 CHALLENGE TOPIC UNDER A FUNDING INITIATIVE BETWEEN THE NCI AND CANCER RESEARCH. THIS NEXT IS TUMOR CONSTRUCTION AND LOOKING AT THE THREE DIMENSIONS SUCH AS WITH TISSUE RECEPTION OR WHOLE BYPASS AND THE TUMOR ARCHITECTURE. AND THE CANCER MOON SHOT SUBCOMMITTEE. THE GOAL WAS TO DESIGN AND DEVELOP TOOLS AND TECHNOLOGIES AND PRODUCTS TO INFORM ON KOL ONCOLOGISTS TO TEACH ABOUT NEXT GEN SEQUENCING TESTING AND GUIDELINES. HELP THEM WITH THE RESULTS WHICH GO TO INDIVIDUAL PATIENTS AND THEN COMMUNICATE THEM WITH THE PATIENTS. THE NEXT IS ADVANCED PROCESSING PLATFORMS FOR MULTI OMIC ANALYSIS. THE GOAL IS TO DEVELOP A ROBUST SAMPLE PROCESSING PLATFORM THAT CAN IMPROVE SINGLE CELL PRE AND AN LIT TACK WORK FLOWS AND COMPATIBLE WITH DOWN STREAM ANALYSIS. THE LONG-TERM GOAL IS TO MOVE THE FORWARD THE FIELD OF MULTI CELL OMICS FOR CANCER CARE AND CLINICAL CARE. THE NEXT TOPIC IS RESOURCE SETTINGS FOCUSSED ON CANCER PREVENTION AND DIAGNOSIS AND THE DELIVERABLES FOR THERAPEUTICS WERE VERY DIFFERENT FROM DELIVERABLES FROM DEVICE AND THE GOAL IS TO DEVELOP COST EFFECTIVE AND AFFORDABLE TECHNOLOGIES FOR CANCER PREVENTION AND DIAGNOSIS THE TARGET LOW RESOURCE SETTINGS BY APPLYING OR ADAPTING EXISTING OR EMERGING TECHNOLOGIES AND PRIOR TI IS -- PRIOR TI TO CANCERS OF THE COLON AND RECTUM AND OTHER CAVITIES. THE NEXT IS AT-HOME SCREENING FOR EXPOSURE OR ACTIVE INFECTION THAT CAN BE USED AS A SELF-TEST IN NON-CLINICAL SETTINGS AND USED THIS IS QUANTITATIVE BIOMARKERS AS MEDICAL DEVICE DEVELOPMENT TOOLS FOR CANCER. AND THE TOOL FOR THIS TOPIC IS TO DEVELOP QUANTITATIVE BIOMARKER TESTS OF ASSAYS AND QUALIFY FOR THE TOOLS AS MEDICAL DEVICE DEVELOPMENT TOOLS. AND THEY CAN EXPEDITE THE APPROVAL PROCESS. NEXT IS COMPUTER AIDED TOOLS FOR THE GASTROAND INTESTINAL TRACT FOR CANCER PREVENTION AND TO ADVANCE THE DEVELOPMENT AND APPLICATION OF ALGORITHMS TO IMPROVE THE PRE-CANCER LESIONS THROUGH THE VIEWING OF LOWER AND UPPER ENDOSCOPIES. AND NEXT IS EYE TOOL FROM THE -- IS A TOOL FROM FDA TO LOOK AT QUALIFIED DATA SETS TO ASSESS MEDICAL DEVICES SUBJECT TO REGULATION BY THE CENTER FOR DEVICES AND [INDISCERNIBLE]. AND THE NEXT IS CELL BASED THERAPIES WITH THE GOAL OF IMPROVING THE SPEED AND COST OF PRODUCING CELL BASED THERAPIES. AND I'D LIKE TO SHARE THE SUCCESS STORIES FROM CONTRACTS WE'VE HAD ANDY THE IMPACT OF THE PROGRAM THIS WAS AWARDED A PHASE 1 TO PROTECT RADIO SENSITIVE ORGANS AND STRUCTURES DURING RADIATION THERAPY. AND THIS CAN BE ATTACHED TO REDUCE CANCER OCCURRENCE. AND THIS WAS ENSURING THE RADIO ACTIVE SEATS WHICH ALLOW THEM TO HAVE RADIATION ON ONE SIDE AND LESS WHERE THERE IS HEALTHY TISSUE AND THE DEVICE RECEIVED THE APPROVALS AND FDA APPROVALS AND NOW COMMERCIALLY AVAILABLE USED FOR PANCRECATTIC AND SARCOMAS AND THERE'S ANOTHER COUNT -- COMPANY FOR CLINICAL TRIALS AND THERE'S THEY LOOKED AT THE CLINICAL TRIAL PLATFORM AND ELECTRONIC CLINICAL OUTCOMES AND SO ON AND IN NOVEMBER 2020 THEY RECEIVED A $91 MILLION FROM INVESTIGATORS SIGNALLING INTEREST IN THE DECENTRALIZED TRIALS. WE DID AN ANALYSIS OF GRANT FUNDING AND THERE WAS 440 COMPANIES THAT RECEIVED $787 MILLION. WITH HAD AN EXTERNAL COMPANY TO FIND IT RESULTED IN $9 BILLION IN SALES APPROXIMATELY $3 BILLION IN TAX REVENUE BACK TO THE GOVERNMENT AND 800,000 NEW JOBS CREATED RESULTING IN $126 BILLION OF TOTAL ECONOMIC OUTPUT TO THE U.S. ECONOMY. THANK YOU FOR LISTENING AND I'M HAPPY TO TAKE QUESTIONS. >> THANK YOU FOR THE PRESENTATION. THE COMMITTEE IS SUPPORTIVE OF THE PROJECTS SHE RAN THROUGH QUICKLY BUT WE WENT THROUGH EVERY ONE ONE BY ONE AS A COMMITTEE. WE SPENT A LOT OF TIME WITH MEMBERS OF THE TEAM WE WONDERED THE PROCESS BY WHICH THE TOPIC WERE CHOSEN. WE ASKED ABOUT THE BUDGET AND HOW SUCCESSFUL WERE THE CONTRACTS AND SUGGESTED IT WOULD BE GOOD TO PROVIDE METRIC TO ENSURE THE CONTRACTS ACHIEVED THEIR GOAL. WE ASKED ABOUT THE RETURN ON INVESTMENT AND WOULD BE GOOD FOR THEM TO HAVE AN EXAMPLE OF FOR THIS CONTRACT. YOU HEARD WHAT THE COLLEAGUES HAVE ADDRESSED AND WE THOUGHT THERE'S A MIX OF TOOLS FOR CANCER TREATMENT AND MEDICAL DEVICES AND WE ADDRESSED HEALTH EQUITY AND SPECIFIC CANCERS AND WE CONCLUDED WITH THE APPROVAL OF THE CONTRACT FOR FY2022. >> YOU SAID IT PERFECTLY. I HAVE NOTHING TO ADD. >> I WANT TO REITERATE A COUPLE POINTS AND IT'S 15% THAT ALLOWS THE NCI TO STRATEGICALLY GO AFTER AREAS THAT THEY WANT TO INVEST IN. I THOUGHT IT WAS A BIG POINT. ANOTHER BIG POINT IS THE SELECTION PROCESS. WHEN YOU READ THESE, THEY'RE VERY SPECIFIC. WE SPENT A LOT OF TIME TRYING TO UNDERSTAND HOW YOU GET SPECIFIC RFAs AND THERE'S A RIGOROUS PROCESS THAT ALLOWED THE NCI AND WHAT SHOULD COME THROUGH IS IT SHOULD SPAN THE ENTIRE CANCER CONTINUUM AND WE'RE PLEASED TO SEE THAT. THERE'S NOT A CLUSTERING IN ANY ONE PLACE IN PARTICULAR. SO SPEAKING FOR MYSELF WE'RE IMPRESSED WITH THIS. >> IS THERE INFORMATION ABOUT IT. I REMEMBER VAGUELY THE PAY LINE. >> THESE GO TO A TECHNOLOGY EVALUATION PANEL WITHIN NCI AND WE BECAUSE THESE ARE CONTRACTS WE HAVE AN INTERNAL DISCUSSION ON WHICH TOPICS WE WOULD LIKE TO PROCEED. USUALLY IF THERE'S A SCORE OF 70 OR ABOVE IS WHERE WE GO AHEAD WITH THIS. AND THEN WE OF COURSE GET AN OPINION AND THERE'S NO PAY LINE WE HAVE AND WE COULD HAVE A DISCUSSION AND WE COULD HAVE MORE DISCUSSION IN HOUSE BEFORE WE FUND A POSITION. >> MAYBE YOU'RE TALKING ABOUT PAY LINES AS A WHOLE. >> YES. >> AS A WHOLE IT USED TO BE [INDISCERNIBLE] AND NO MORE. THE MECHANISM IS LOW THIS YEAR. WE'RE GETTING NEW STUFF. THEY'RE BETTER FOR STTRs BUT SPIRs ARE HIGHLY COMPETITIVE. >> THE REASON I'M BRINGING IT UP BECAUSE MAYBE FOR A SEPARATE DISCUSSION THERE'S A SENSE AT LEAST IN SOME DISCUSSIONS THAT I'VE BEEN ON THAT THE POOL OF CANCER RESEARCHERS WILLING DEVOTE TIME AND EFFORT TOWARDS THESE PARTICULAR ACTIVITY IS NOT GREAT. THERE ARE ATTEMPTS THROUGH OTHER ACTIVITIES TO INCREASE THE POOL. I'M CURIOUS WHETHER IT'S REFLECTED BY THE COMPETITION OF THE MECHANISM. JUST SOMETHING TO GIVEN THE IMPORTANCE AND RETURN ON INVESTMENT FOR THE MECHANISM. >> APART FROM OUR REGION AND SEVERAL [INDISCERNIBLE] IT'S A PRACTICE AND THIS IS A MAJOR PART OF THE CYCLE AND TRANSLATION AND GRANTS AND THE MECHANISMS. THIS IS AN IMPORTANT PART OF CLOSING THE LOOP. >> MARTIN? I THINK THE RETURN ON INVESTMENT IS VERY GOOD. >> THE RETURNS ARE PHENOMENAL AND WONDER IF WE CAN GET MORE BY INCREASING THE POOL OF PEOPLE WHO HAVE GOOD IDEAS THAT DON'T HAVE NECESSARILY THE TIME OR SKILLS TO MOVE THEM INTO THE MECHANISM. I AGREE, IT'S A VERY IMPORTANT MECHANISM >> I WANTED TO ADD ABOUT A NEW FUNDING OPPORTUNITY BEFORE THE BSA LAST TIME AND THAT'S A SMALL BUSINESS TRANSITION GRANT AND THAT WAS INTENDED TO TAKE TECHNOLOGIES FROM ACADEMIA TO INDUSTRY AND COMBINED WITH TRAINING. USUALLY YOU HAVE JUNIOR FACULTY POST-DOCS TO MOVE WITH THE TECHNOLOGY AND GIVE THEM TRAINING WITH THE FUNDS FOR PRODUCT DEVELOPMENT AND THAT IS ON THE STREET RIGHT NOW. >> VERY GOOD. >> WHEN I FIRST ARRIVED AT NCI WE HAD A WORKING GROUP AND ONE QUESTION WAS HOW TO GET MORE P.I.s INVOLVED. I THINK OUR DECLINING SUCCESS RATES HAVE SHOWN WE ACCOMPLISHED THAT WHICH IS GOOD AND BAD NEWS. IT'S STILL AN AREA WHERE WE LOOK TO SEE IF WE'RE DOING THINGS RIGHT. I DON'T THINK WE HAVE ENOUGH FEMALE P.I.s AND IT'S IMPROVING BUT NOT QUICK ENOUGH FOR MY TASTE. WE HOPE THE NEW MECHANISM IS FOR A RAPID AWARD MAY HELP IN THIS REGARD. IF YOU LOOK AT THE ROI ANALYSIS IT'S IMPRESSIVE. BETTER THAN ANY GIVEN THE 35X RETURN OR WHATEVER WE'RE GETTING. I THINK SOMETHING ELSE YOU MAY HAVE NOTICED IS MORE OF A WINK WITH THE DEVICE TO FDA ASKING WHAT THEY NEED AND THEY HAVE SPECIFIC INTEREST AND THAT'S A HARD COMMERCIAL PATH. I THINK NCI IS TRYING TO BE HELPFUL AND THERE'S OTHER THINGS WE CAN DO TO MAKE THE POOL BETTER THAN IT IS. >> ANY TRAINING GRANTS THAT EMPHASIZE IT, NED? >> WHAT WE TALKED ABOUT IS TO FIGURE OUT HOW TO DO TRAINING. THAT'S A JOINT COLLABORATION TO FIGURE OUT HOW TO DO THAT. >> OKAY. ANY OTHER QUESTIONS OR COMMENTS ON THIS PARTICULAR CONCEPT? >> [AUDIO DIGITIZING] >> OKAY. SO IF THERE'S NO OTHER QUESTIONS OR COMMENTS, THIS IS A NEW CONCEPT I WOULD LIKE TO ASK FOR A MOTION. >> I MOVE. >> SECOND. >> ANY DISCUSSION? ANY NOT APPROVE? ANY ABSTENTIONS? OKAY. UNANIMOUS. IT'S 3:45 ON THE DOT. >> GREAT WORK. WELL DONE. >> LET ME CLOSE THE MEETING BY SAYING IF THERE'S ANY AGENDA ITEMS YOU'DLIKE THE BOARD TO HAVE AT FUTURE MEETINGS, SEND THEM TO ME AND PAULETTE AND FEEL FREE TO SHARE WITH US ANY THOUGHTS YOU HAVE REGARDING TODAY'S MEETING. I CAN JUST TAKE THE CHAIR PREROGATIVE AND SUGGEST WE REVISIT IN THE NEXT MEETING THE TOPIC WE DISCUSSED ABOUT THE MOON SHOT FUNDING AND THE SUN SETTING OF SOME OF THESE PROGRAMS AND TRANSITIONING TO THE REGULAR NCI PORTFOLIO. AND IF THERE'S NO OTHER BUSINESS ITEMS WE ARE ADJOURNED AND WE'LL SEE EACH OTHER AT THE JUNE 13 AND 15 JOINT MEETING. STAY WELL AND ENJOY THE REST OF THE AFTERNOON.