WELCOME STAFF AND GUESTS. BEFORE WE BEGIN TODAY, THERE'S SOME REQUIRED HOUSEKEEPING AND I MUST ATTEND TO. MEMBERS OF THE PUBLIC WHO MAY WISH TO EXPRESS VIEWS REGARDING ANY DISCUSS MAY DO BY WRITING SECRETARY OF THE BOARD AND WITHIN 10 DAYS FOLLOWING THE VIRTUAL MEETING. THEY WILL RECEIVE CAREFUL CONSIDERATION. I WANT TO REMIND YOU, YOU MUST ABSENT YOURSELF DURING DISCUSSIONS WHEN YOU ARE PARTICIPATION AND DELIBERATIONS ON A PROJECT, PROGRAM OR OTHER SPECIFIC MALTERS WHO CONSTITUTE A CONFLICT OF INTEREST OR CREATE THE APPEARANCE OF ONE. ADVISE THE SECRETARY AND ABSTAIN FROM PARTICIPATION AND DISCUSSION OR ACTION REGARDING THAT MATTER. IN LIGHT OF THE CURRENT POLICIES AND CONFLICT OF INTEREST ON FINANCIAL HOLDINGS AND SPECIAL GOVERNMENT EMPLOYEES WHICH INCLUDE ALL MEMBERS OF THIS BOARD, WE MUST DEPEND ON YOU TO ABSENT YOURSELF DURING ALL AND DISCUSSION MATTERS THAT COULD IMPACT THE STATUS OF THOSE HOLDINGS. WE TRUST YOUR JUDGMENT IN THESE INSTANCES. TO ENSURE NO INTERRUPTS TODAY, PLEASE MUTE YOURSELVES AND REMAIN SO UNTIL RECOGNIZED MYSELF, PAULETTE, AT THE NCI DIRECTOR AND THESE SPEAKERS. BY WE CAN'T PREDICT THE TIME OR CURRENT OF MOTION YOUR PRESENCE IN THE VIRTUAL MEETING ROOM FOR ALL SEGMENTS OF THE MEETINGS IS A MUST. OUR NEXT MEETING SPANS JUNE 14th AND 15th OF THIS YEAR. THIS IS GOING TO BE A JOINT MEETING WITH THE NATIONAL CANCER ADVISORY BOARD AND IT WILL BE AN IN-PERSON MEETING. OUR FIRST ONE IN THREE YEARS. WITH HYBRID PARTICIPATION POTENTIAL FOR THOSE WHO ARE UNABLE TO MAKE IT IN-PERSON. PLEASE MARK YOUR CALENDARS. A LIST OF FUTURE MEETING DATES IS ON THE AGENDA. AS SUCH, WE NEED TO CONFIRM THE 2025 MEETING DATES WHICH ARE ALSO LISTED ON THE AGENDA. I'D LIKE TO CALL FOR A MOTION SECOND AND DISCUSSION REGARDING THE PROPOSED MEETING DATES. I THINK PAULETTE, THAT'S THE ONLY ITEM SPECIFICALLY AT THIS POINT? >> CORRECT. >> Dr. Flaherty: GREAT. I'M ASSUMING YOU ALL REVIEWED THE AGENDA WITH THOSE DATES BASICALLY I NEED A MOTION AND A SECOND TO GET US MOVING IN THAT DIRECTION. THANK YOU. >> MOVE TO APPROVE. >> Dr. Flaherty: THANK YOU. AND AS WELL. SO THAT WAS A MOTION AND A SECOND. ANY DISCUSSION REGARDING THE PROPOSED MEETING DATES? OBVIOUS CONFLICTS THAT MIGHT INTERFERE WITH MEETING ON THOSE DATES. >> JUST QUICK CLARIFICATION, VERY MUCH APPRECIATED THAT WOULD BE GREAT AND SO, AM I TO ASSUME TENTATIVE SCHEDULE AS YOU COME IN ON THE 14th OR COME IN ON THE 15th BECAUSE IT'S TWO FULL DAYS? >> YOU SHOULD COME IN ON THE 13th BECAUSE THE MEETING WILL START IN THE 14th. >> IN THE MORNING? OKAY. RIGHT. ALL RIGHT. AND WE'LL ABOUT THROUGH THE 15th. I'M JUST TRYING TO PLAN SCHEDULES? >> WE HAVEN'T FOCUSED ON THE JUNE AGENDA YET. IN THE PAST WE'VE INCLUDED AROUND MID-DAY ON THE SECOND DAY. >> SOMETIMES 6789 WHICH HOPE THERE'S A GOOD MANY MORE CONCEPTS TO DISCUSS AT THE JUNE MEETING AND SO PAULETTE WILL KEEP US ADVISED IN TERMS OF THE NUMBER AND ITS IMPACT ON THE AGENDA BUT A DAY AND A HALF IS TYPICAL. ANY OTHER DISCUSSION? OKAY. SO, WITH A MOTION AND A SECOND TO APPROVE THESE MEETING DATES AND AS WITH OUR REGULAR VOTING PROCESS, WHEN WE'RE MEETING VIRTUALLY, ONLY LOOKING FOR YOUR PRESENCE ON CAMERAS AND EMPHASIS AT PRESENCE ON CAMERA IS TAKEN AS AN AN ACCENT. PEOPLE CAN ABSTAIN ALTHOUGH I DO NOT EXPECT ABSTENTIONS FROM THIS VOTE. ANY NAY VOTES IN TERMS OF THE PROPOSED MEETING DATES? OKAY. CHECKING ON THE SECOND SCREEN >> Dr. Flaherty: THE FIRST IS THE NCI DIRECTOR'S REPORT. MONICA BERTAGNOLLI. >> Dr. Bertagnolli: OKAY. THANK YOU, Dr. FLAHERTY, AND THANK YOU Dr. GRAY. IT'S WONDERFUL TO SEE YOU ALL AND I'M LOOKING FORWARD TO AN IN-PERSON MEETING IN JUNE. THAT WILL BE FANTASTIC. SO TODAY, I'LL GOING TO TALK ABOUT RESENT PROGRESS. A LITTLE BIT ABOUT OUR BUDGET OUTLOOK, ABOUT THE NATIONAL CANCER PLAN AND THEN ALSO SOME BRIEF, VERY BRIEF PROGRAM AND RESEARCH UPDATES. I'M SURE MANY OF YOU SAW THE STATE OF THE UNION ADDRESS PRESIDENT JOE BIDEN CONTINUES TO SHOW VERY STRONG SUPPORT FOR WHAT WE ALL SEEK TO DO. LAST MONTH, HE REITERATED HIS MESSAGE HE WILL GO BIG IN ORDER TO ACHIEVE BOLD GOALS FOR PROGRESS AGAINST CANCER AND HIS SPEECH WAS TOUCHING. YOU KNOW, IN HIS UNIQUE WAY, HE ALWAYS MAKES SURE WE KNOW WHO WE'RE HERE TO SERVE. HE CALLED ATTENTION TO EVA, WHO IS A 3-YEAR-OLD GIRL WITH A RARE KIDNEY CANCER AND HER PARENTS WERE UNTIL THE AUDIENCE THERE AND YOU COULD REALLY SEE ON THEIR FACES THE STRUGGLE THEY'VE BEEN THROUGH, THEIR COURAGE AND THEIR HOPE. THE GREAT NEWS IS THAT EVA'S OUTLOOK APPEARS VERY PROMISING. WE CAN NEVER FORGET IT'S PEOPLE LIKE HER AND HER PAMLY THAT WE'RE HERE TO SERVE. NEXT SLIDE, PLEASE. >> SO THE SER MOONSHOT, PRESIDENT BIDEN HAS REITERATED HIS CALL TO END CANCER AS WE KNOW IT. WE HAVE A FIRM GOAL TO CUT THE MORTALITY RATE BY 50% IN 25 YEARS TO TURN MORE CANCERS FROM DEATH SENTENCES INTO TREATABLE DISEASES AND PROVIDE MORE SUPPORT FOR PATIENTS AND FAMILIES. ACHIEVING THIS WILL CERTAINLY BE TRANSFORM THE EXPERIENCE WITH CANCER AND SOMETHING WE THINK NOT ONLY IMPORTANT AND IT'S VERY ACHIEVABLE. WE'LL EXCELLENT DONE BY NCI DIVISION OF CANCER AND GENETICS ANAND IT AND THERE ANNA COMPANY COMMENTARY AS WELL SOME EFFORTS UPCOMING AT AACR IN APRIL. SO, KEEP ON THE LOOK OUT FOR THIS. NEXT SLIDE. THE 2024 BUDGET BREAKDOWN. WELL, PRESIDENT JOE BIDEN SHOWED HOW MUCH OF A PRIORITY CANCER PROGRESS IS TO HIM. IN HIS FISCAL YEAR 2024 BUDGET REQUEST JUST RELEASED LAST WEEK. HE PROPOSED A TOTAL BUDGET OF 7.8 BILLION FOR NCI FOR FISCAL YEAR 2024. WHICH WOULD BE A 6.9% INCREASE. THAT WOULD BE A GREAT BOOST. AS YOU KNOW, WE'RE IN THE LAST YEAR OF 21st CENTURY CURES AGENT FUNDING PROVIDED THE MOONSHOT PENDING HELPED US TO LAUNCH AN INCREDIBLE ARRAY OF TRANSFORMATIVE RESEARCH PROJECTS. THE PRESIDENT'S BUDGET WOULD HELP US AVOID A FUNDING CLIFF WITH 216 MILLION YOU SEE THERE IN THE MIDDLE, WHICH MATCHES THIS YEAR'S AMOUNT. HE ALSO CALLED FOR A $500 MILLION INCREASE FOR NEXT YEAR GIVING US $716 MILLION TOTAL INCREASE FOR NCI FOR 2024. ONE SOMEWHAT UNUSUAL AND EXCITING ASPECT OF THE BUDGET IS IT ALSO PROPOSES REAUTHORIZATION OF THE 21st CENTURY CURES ACT AND MANDATORY FUNDING OF $1.45 BILLION BUDGET AUTHORITY FOR NCI IN FISCAL YEAR 2025 AND 2026. SO, WE ARE VERY EXCITED TO SUPPORT THOSE AUTHORIZING EFFORTS HAD THE FUTURE. YOU SEE HERE THAT IN RESENT YEARS, CONGRESS APPROPRIATION HAS COME IN HIGHER THAN THE PRESIDENT'S NUMBERS SIGNALING THEIR STEADY COMMITMENT TO CANCER PROGRESS. WITH THIS BUDGET REQUEST, HOWEVER, PRESIDENT JOE BIDEN HAS TRULY COMMUNICATED TO CONGRESS THAT HE WANTS TO GO BIG. IT WILL BE UP TO CONGRESS TO DECIDE HOW MUCH FUNDING IS ACTUALLY APPROPRIATED TO HAVE NCI AND ACROSS ALL FEDERAL AGENCIES. M.K. HOLOHAN WILL SPEAK ABOUT WHAT IT MEANS IN HER SECTION TO FOLLOW. WE GOT GOOD NEWS FROM CONGRESS IN DECEMBER. PRESIDENT JOE BIDEN SIGNED LEGISLATION THAT PROVIDED BIDE THROUGH SEPTEMBER 30th OF THIS YEAR TO OUR BASE BUDGET AS WELL AS A $22 MILLION INCREASE TO THE FINAL YEAR OF INITIAL MOONSHOT FUNDING. THAT MEANS, WHEN YOU ADD IT ALL UP, WE RECEIVED $216 MILLION IN MOONSHOT FUNDING FOR 2023 AS ANTICIPATED FROM THE 21s 21st CENTURY CURES ACT. THE ADDITIONAL INCREASE TO OUR BASE MADE IT POSSIBLE TO FUND MORE COMPELLING BELONG WORKER EFFORTS OUTSIDE OF THE POOL LIKE OUR CLINICAL TRIALS NETWORKS, CORE SUPPORT FOR NCI DESIGNATED CANCER CENTERS AND THIS CONTINUES OUR UPWARD TREND FROM THE EIGHTH PERCENTILE IN 2019 AND IT'S STILL NOT AS HIGH AS WE WOULD LIKE AND WE'RE STILL LEAVG INNOVATIVE IDEAS ON THE TABLE. IT SHOWS THAT WE'VE MADE STEADY PROGRESS IN OUR ABILITY TO FUND IMPORTANT RESEARCH. WE WERE ALSO ABLE TO INCREASE THE EARLY STAGE INVESTIGATOR RO1s TO THE 17th PERCENT UP FROM 16 PERCENT. BECAUSE OF THESE PAYLINE INCREASES, WE ARE ABLE TO FUND MORE THAN 100 ADDITIONAL RO1s AND THE ESI AWARDS COMPARED TO LAST YEAR. RPG FUNDING IS CRITICAL. IT ALLOWS INVESTIGATORS ACROSS THE NATION TO SUBMIT THEIR VERY BEST IDEAS AND TURN THEM INTO ANSWERS THAT DRIVE PROGRESS. IF IN ADDITION, FUNDING CRITICAL INFRASTRUCTURE INCLUDING INFORMATION TECHNOLOGY IS OF A BIG PRIORITY FOR NCI. THESE ARE THE THINGS THAT AMPLIFY RESEARCH RESULTS, DRIVE NEW COLLABORATION AND ENSURE MAXIMAL USE OF OUR PRIOR INVESTMENTS IN RESEARCH. SO WE'VE ALSO ALLOCATED NEW FUNDING TO MEET THESE GOALS. UNFORTUNATELY, WE, LIKE ALL OF YOU, HAVE NOT BEEN MANY UN IMMUO SIGNIFICANT INFLATION. AS A RESULT, THESE DECISIONS TO SUPPORT THE RPG POOL AND SUPPORT OUR INFRASTRUCTURE ALSO MEANS WE'VE NEEDED COST-CUTTING ELSEWHERE. WE DECIDE TODAY PAY MOST CONTINUING RAIN CON POM EATING GRANTS THAT IS YEARS TWO THROUGH FIVE OF THE FIVE-YEAR GRANT AT 98% AND -- JUST AS WE ASKED OUR INTRAMURAL RESEARCHERS TO DO. AND THIS SLIDE JUST ILLUSTRATES THE CHALLENGE THAT -- AND YOU MIGHT HAVE SEEN THIS IN OUR FISCAL YEAR 2024, PROFESSIONAL JUDGMENT BUDGET ON THE WEBSITE SHOWS THE CHALLENGE WE TAKE ON EVERY TIME WE RAISE THE PAYLINE BY 1%. WHEN WE INCREASE THIS, WE MAKE A COMMITMENT TO SUSTAIN THOSE NEW GRANTS FOR FIVE YEARS IN THE FUTURE. WE ALWAYS REQUIRE ADDITIONAL RESOURCES IN THE OUT YEARS WHICH ARE YEARS TWO THROUGH FIVE JUST TO SUSTAIN FUNDING AT THAT PERCENT STYLE LEVEL. AND EVEN MORE, IF WE ARE TO GO ON TO FURTHER INCREASE THE PAYLINE. LET ME EMPHASIS OUR PAYLINE AT 12% THIS YEAR IS THE HIGHEST IT HAS BEEN SINCE 2010. I'M SURE YOU WILL AUTOMATIC SEE ALL SEE THEIMPORTANCE MUCH THIST INTRODUCES FUNDING CHALLENGES FOR FUTURE AND HAS ALSO ASKED US TO DO SOME BELT-TIGHTENING ELSEWHERE. I WROTE ABOUT THESE BUDGET DECISIONS IN A RESENT POST ON THE NCI BOTTOM LINE BLOG. AS FOR THE NCI CANCER CURRENT BLOGS, I ALSO WROTE A POST THAT EMPHASIZES THAT THIS REALLY IS A GREAT OPPORTUNITY FOR CANCER RESEARCH. HIGHLIGHTING PROGRESS FROM DECADES OF INVESTMENTS, PRESIDENT JOE BIDEN'S COMMITMENT, AND IMPORTANT NEW NCI PROGRAMS. I ALSO UNDERSCORED IN THIS BLOG THE IMPORTANCE OF THE LAST MILE. FROM VALIDATION OF A SUCCESSFUL INTERVENTION AGAINST CANCER TO ITS WIDESPREAD ADOPTION AND BROAD IMPLEMENTATION. THIS LAST MILE REQUIRES PARTICIPATION FROM SO MANY OTHERS THROUGHOUT OUR SOCIETY. I WANT TO EMPHASIZE IF WE ARE GOING TO END CANCER AS WE KNOW IT AND NOT SURE ALL OF OUR ADVANCES BENEFIT EVERYONE WHO NEEDS THEM, IT TAKES ALL OF SOCIETY APPROACH TO BRIDGE THE GAP. NCI CANNOT DO THIS ALONE. IN THIS POST, I ALSO TOUCHED BRIEFLY ON OUR NEW NATIONAL CANCER PLAN, WHICH IS AIMED AT EXACTLY THIS LAST-MILE ISSUE. OVER THE LAST FEW MONTHS, WE WORKED WITH RESEARCHERS REPEATING BOTH WITHIN AND OUTSIDE OF THE NCI TO PRODUCE A NEW NATIONAL CANCER PLAN TO ALIGN BROAD SOCIETAL ENGAGEMENT AND FOCUS ON CRITICAL NEEDS TO END CAP SER AS WE KNOW IT. AND THAT MEANS EVERYBODY WITH CANCER AND EVERY CANCER. IT EMBRACES THE IDEA THAT EVERYONE HAS A ROLE TO PLAY ACROSS FEDERAL AGENCIES AND AS WELL AS INDUSTRY AND ANG A DAMIA, ADVOCACY GROUPS, NON PROFITS EVEN CAREGIVERS AND INDIVIDUAL PATIENTS. OUR INTENT IS WHEN ANY ORGANIZATION OR PERSON LOOKS AT THIS PLAN, THEY WILL SEE WHERE THEY FIT AS A CONTRIBUTE OOR TO PROGRESS. IT PROVIDES A FRAMEWORK THAT WILL HELP EVERYONE SEE THE FULL RANGE OF WHAT IS NECESSARY TO BE ABLE TO STRATEGIZE AND MOST IMPORTANT OF ALL TO WORK TOGETHER TO SUSTAIN AND ACCELERATE PROGRESS. WE'RE IN THE FINAL PHASES NOW AND WE ARE GETTING INPUT FROM SUCH A WIDE RANGE OF STAKEHOLDERS ON THIS PLAN. IT WILL VERY SOON BE FINALIZED AND COMMUNICATED WIDELY TO BE TO THE PUBLIC. JUST TO BE CLEAR, THE NATIONAL CANCER PLAN IS NOT THE SAME AS THE REIGNITED CANCER MOONSHOT. THE CANCER PLAN IS ALIGNED WITH ALL OF THE MOONSHOT GOALS. IT PROVIDES A VISION FOR EVERYONE ACROSS ALL SOCIETY TEE TO WORK TOWARDS THOSE GOALS AND REALLY FOCUSES ON HOW WE WILL UTILIZE OUR COLLECTIVE RESOURCES SO THAT WE ACHIEVE THE FASTEST POSSIBLE RESULTS TO END CANCER AS WE KNOW IT FOR ALL PEOPLE. THE MOONSHOT IS HOW THE PRESIDENT IS CALLING ON ALL OF US TO MOBILE SIZE SOCIETY TO TAKE ACTION, BRING GOVERNMENT AGENCIES TOGETHER TO FOCUS AND WORK TOGETHER AND HE IS ALSO ADVOCATING FOR THE RESOURCES NEEDED TO ACCELERATE OUR PROGRESS. SO IN THIS WAY, THE NATIONAL CANCER PLAN AND THE MOONSHOT WORK VERY MUCH HAND IN HAND. AND WE ARE COORDINATING WITH THE WHITE HOUSE TO ENSURE THE NATIONAL CANCER PLAN PROVIDES A FOCUS FOR ACHIEVING THE GOALS OF THE CANCER MOONSHOT. ANOTHER VERY IMPORTANT THING TO DRY YOUR ATTENTION TO IS ARPA-H. THE NEW ADVANCED RESEARCH PROJECTS AGENCY FOR HEALTH. A VERY IMPORTANT -- NEW PARTNER FOR CANCER RESEARCH. RENEE WEGRZYN AND I TALK FREQUENTLY AND WORKING TOGETHER TO DECIDE HOW ARPA-H AND NCI CAN HAVE THE MOST POWERFUL COLLABORATION. I CAN TELL YOU THAT ACROSS ALL OF NIH, WE'RE GIVING HER MANY GOOD IDEAS FOR HOW THIS NEW AGENCY CAN HELP ALL OF US. WE KNOW THAT THERE WILL BE SOME NOTABLE DIFFERENCES IN HOW FAR NCI AND ARPA-H WILL OPERATE. THESE WILL HELP US TO BE COMPLIMENTARY. WHAT NCI DOES, OFTEN REQUIRED MANY DECADES. WE TAKE THE LONG VIEW AND SUSTAIN OUR PROGRAMS OVER TIME. WE ARE RESPONSIBLE AT NCI FOR EVERYTHING FROM FUNDAMENTAL SCIENCE ALL THE WAY TO CARE DELIVERY RESEARCH TO ENSURE THAT A LABORATORY DISCOVERY TRANSLATES INTO A OF CLINICALLY TESTED PROCEDURES DRUG OR DEVICE THAT BENEFITS PEOPLE. ARPA-H IS FOCUS IS VERY DIFFERENT. THINK OF IT AS A SWAT TEAM OR RAPID DEPLOYMENT THAT IDENTIFIES KEY ISSUES WITH HIGH-RISK, HIGH REWARD, RESEARCH FOCUS. THEY THEN NOT ENGAGE THE MOST IMPORTANT PLAYERS FROM ACROSS THE RESEARCH AND DEVELOPMENT ECOSYSTEM TO SOLVE A PROBLEM IN A RELATIVELY SHORT TIMEFRAME. WE'RE VERY EXCITE TODAY WORK IN WAYS THAT COMPLIMENT WHAT ARPA-H BRINGS. WE VIEW OURSELVES AS THE RECEIVE OF THESE SOLUTIONS TO PROBLEMS THAT ARPA-H PRODUCES. AND THOSE PROVIDING SCIENTIFIC LEADERSHIP TO THEIR PROJECTS O THEY BEST ADDRESS THE NEEDS OF CANCER RESEARCH. NEXT SLIDE. I'M ALSO PLEASED TO SAY THAT THE CANCER GRAND CHALLENGES COLLABORATION HAS ENTERED INTO A NEW PHASE THROUGH OUR PARTNERSHIP WITH CANCER RESEARCH U.K., WE JUST ANNOUNCED NINE NEW RESEARCH CHALLENGES AIMED AT TACKLING PROFOUND PROBLEMS IN RESEARCH, YOU SEE THEM LISTED. TO SUPPORT THE BRIGHTEST MINDS ACROSS THE GLOBAL RESEARCH COMMUNITY AS THEY TACKLE SOME OF THE MOST COMPLEX CHALLENGES IN CANCER RESEARCH. NCI CLINICAL TRIALS ARE ABSOLUTELY ESSENTIAL. THEY TURN POSSIBILITIES INTO TREATMENT PREVENTION AND EARLY DETECTION OR DIAGNOSIS METHODS. FOR A VARIETY OF REASONS, WE JUST DON'T HAVE ENOUGH PEOPLE PARTICIPATING IN OUR TRIALS AND ESPECIALLY THOSE FROM MINORITY GROUPS OR FROM RURAL AREAS AND WE ALSO DON'T GET RESULTS FAST ENOUGH. WE NEED NEW STRUCTURES THAT ARE MORE NIMBLE AND MORE INCLUSIVE OF ALL OF THE PEOPLE WE'RE HERE TO SERVE. SO AT NCI WE'VE LAUNCHED WHAT WE'RE CALLING OUR CLINICAL TRIALS INNOVATION UNIT TO SPEARHEAD PROGRESS. THIS IS A VERY EXCITING COLLABORATION BETWEEN NCI, THE FDA, AND THE EXTRAMURAL CANCER CLINICAL RESEARCH COMMUNITY. THE UNIT WILL SELECT A FEW VERY HIVE PRIORITIES SCIENTIFIC QUESTIONS THAT ARE PARTICULARLY STUDY DESIGN AND OPERATIONAL PROCEDURES. THIS IS FOR THIS INNOVATION UNIT, ALL ASPECTS ARE ON THE STABLE. STUDY ELIGIBILITY, COMPARE ARMS, ENDPOINTS, DIAGNOSTICS, USE OF TELEHEALTH AND OTHER STUDY DATA COLLECTION AND PROCEDURES AND PARTICIPANT ENGAGEMENT STRATEGIES AND EVERYTHING THAT CAN HELP US ENGAGE MORE BROADLY AND DELIVERING RESULTS FASTER IS OPT TABLE. WE ANTICIPATE SUCCESS WILL APPROACH US AND -- WE HAVE A FEW IMPORTANT UPDATES. EARLY DETECTION OF CANCERS CAN SIGNIFICANTLY IMPROVE OUTCOMES BUT THAT UNFORTUNATELY, NOT ENOUGH PEOPLE ARE GETTING THE RECOMMENDEDDED SCREENING. A NEW NCI FUNDED STUDY FOUND THAT AMONG A SAMPLE OF PRIVATE SECTOR WORKERS, MEMBER OGRAPHY AND COLORECTAL SCREENING, WERE HIGHER IN AREAS WHERE THIS SUGGESTS A LACK OF PAID SICK LEAVE COVERAGE PREVENTS A BARRIER TO CANCER SCREENING AND INFORM POTENTIAL POLICY SOLUTION THAT'S COULD BOOST SCREENING AND SAVE LIVES. WE KNOW THAT ALCOHOL CAN INCREASE RISK OF DEVELOPING SEVERAL CANCER TYPES. AND AN NCI STUDY FOUND THAT MOST AMERICANS WEREN'T AWARE OF THIS CONNECTION. THE RESEARCHERS CONCLUDED THAT CHANGES NEED TO BE MADE TO RAISE PUBLIC AWARENESS OF THIS IMPORTANT FACT. WE KNOW THAT AWARENESS DOESN'T GUARANTEE ACTION. WE'LL NEED FURTHER RESEARCH TO SOLVE THESE CHALLENGES. WE MAY BE ON THE PATH TO NEW ANSWERS TO A CHILDHOOD CANCER THAT IS DIFFICULT TO TREAT. EVEN OCCURS IN SOME DIFFICULTIES. RESEARCH SPONSORED BY OUR CANCER MOONSHOT'S FUSION ONCOPROTEINS IN FOUND THAT THE EVT6 PROTEIN MODULATES THE INFUSION ON CO PROTEIN RESPONSIBLE FOR THE MAJORITY OF EWING CAR COMA. IT'S HOPED IT WILL PREVENT A TARGETED DRUG THAT INTER FIERCE WITH THE ACTION BETWEEN EVT6 AND THE FUSION ON CO PROTEIN AND LEAD TO TREATMENT. WE ANTICIPATE SEEING MORE MORE RESULTS OUT OF THIS VERY IMPORTANT MOONSHOT CONSORTIUM. THE CHILDHOOD CANCER DATA INITIATIVE IS REALLY PROCESSING IN LINE WITH ALL OF OUR HOPES FOR THIS IMPORTANT PROGRAM. GETTING DATA WE NEED TO IMPROVE OUR UNDERSTANDING OF CANCER, ESPECIALLY CHILDHOOD CANCER, WHERE DATA HAS BEEN DIFFICULT TO COME BY IS VERY CHALLENGE AND COSTLY AND THE GOOD NEWS IS HEAD LAY AND TO GET MUCH CHILD AND INTO THE HANDS OF SCIENTISTS THROUGH CCDI. THIS FOCUS PROGRAM HAS MADE TREMENDOUS PROGRESS TO ACCUMULATE DATA THAT HAS BEEN HISTORICALLY VERY DIFFICULT FOR RESEARCHERS TO ACCESS AND FOR RESEARCH TEAMS TO SHARE. THE AGREEMENT IS TAKEN CHARGE OF CCDI BRINGING HIS VAST EXPERIENCE FROM TIME LEADING AND ALSO WORKING AT FDI AND MARCH 21st, CCDI WILL HOST THE SYMPOSIUM TO GATHER EXPERTS FROM ACROSS COUNTRY AND WE'RE VERY EXCITED TO HIGHLIGHT NEW RESOURCES THAT ARE AVAILABLE TO THE SCIENTIST I CAN COMMUNITY. AS WELL AS HIGHLIGHT FUTURE AND OPPORTUNITIES. AND TO INTEND YOU CAN DO IT IN-PERSON EVEN IF YOU ARE NOT AND RESEARCHER BUT IF YOU ARE PARTICULARLY INTERESTED IN CHILDHOOD CANCER AND TO ALL OF OUR WORK. IT'S A PLAN FOR THE FUTURE. I THINK MORE THAN ANYTHING THAT WE'VE DONE, CCDI IS DEMONSTRATING THE GREAT POWER OF DATA SHARING AND COLLABORATION AND WE REALLY THINK THIS CAN BE A PARADIGM FOR WHAT WE CAN DO FOR EVERYONE WITH CANCER AND EVERY RESEARCH TEAM. SOME FINAL THOUGHTS, THERE'S A LOT HAPPENING. FROM STEP-BY-STEP SCIENCE THAT WE SIMPLY WON'T MAKE PROGRESS WITHOUT, WHICH WE'RE VERY HAPPY TO SAY WE'LL INCREASE WITH MORE RO1 FUNDING, TO HIGH-LEVEL PLANNING TO LEAD OF BEST ALIGN THE CANCER RESEARCH ENTERPRISE AND TRULY ALL OF OUR SOCIETY AS WE ACHIEVE THE PROGRESS EVERYONE IS COUNTING ON. WE'RE STILL VERY FAR FROM WHERE WE NEED TO BE FOR THE PEOPLE WHO ARE COUNTING ON US. BUT I'M REALLY EXCITED ABOUT THE STEPS WE'RE TAKING NOW AND RECENT ACCOMPLISHMENTS TO ENSURE WE CAN WORK TOGETHER AND WE'RE ON THE RIGHT PATH TO DO SO. SO LET ME END HERE, AND GET TO THE BEST PART WHICH IS TO TAKE ALL OF YOUR QUESTIONS. IF YOU. >> HI. THANK YOU, THAT'S ABSOLUTELY WONDERFUL. SO EXCITE TO GO SEE. I'M CURIOUS ABOUT THE INNOVATIONS FOR CLINICAL TRIALS. YOU MENTIONED THE BROAD SCOPE. I KNOW YOU KNOW WHAT I'M GOING TO ASK. DOES INNOVATIONS INCLUDE BETTER WAYS TO WRITE TRIALS AND AUTHOR TRIALS AND WHAT ARE YOUR THOUGHTS ABOUT WAYS WE CAN ENCOURAGE THE SPONSORS TO USE STRUCTURED FORMS OF AUTHORIZING TRIALS THAT MAKE IT EASIER TO DO DOWNSTREAM INA LIT TICKS AND. >> EVERY PASS OF TRIAL DESIGN IS ON THE STABLE AND AND INCLUDING WHAT YOU JUST DESCRIBED AND WHAT IS GIVING US, GOT US REALLY EXCITED AND YOU MENTIONED INDUSTRY AND I MEAN, ANY COLLABORATORS AND WE'RE EXCITED ABOUT FDA IS AT THE TABLE THEY'RE WEIGHING IN AND I CAN TELL YOU THAT THE FIRST TRIAL TO COME OUT OF THE FIRST-GENERATION OF THE TRIALS AND IT'S A REGISTRATION TRIAL DESIGNED TO BE REALLY, REALLY NIMBLE AND SIMPLE AND STRAIGHT FORWARD AND ABLE TO EVERY COMMUNITY AND UNITED STATES THROUGH THE NCTN AND THE ENCORE SO HAVING FDA THERE HAS BEEN A POWERFUL FORCED TO MAKE SURE THAT WE CAN DO THIS. KAREN. >> >> THANK YOU FOR THAT PRESENTATION MONICA IT'S GREAT AND EXCITE TO GO SEE THE PROGRESS. ANY QUESTIONS ABOUT ARPA-H AND BEING DONE WITHIN NCI AND THE RIGHT KIND OF PROTECT OR ARPA-H. >> ARPA-H HAD ITS FIRST YEAR, FIRST YEAR CELEBRATION AND AT THAT TIME, YOU CAN GO TO THEIR WEBSITE THERE'S NOW A BROAD AGENCY ANNOUNCEMENT AND OUT TO BE SO ANYONE CAN SUBMIT PROPOSALS AND ARPA-H AND THEY'RE AND THEIR PROJECT MAPPINGERS AND ANY IDEAS CAN GO THERE. WE'RE TELLING PEOPLE HOW TO COLLABORATE WITH NCI AND WE HAVE Dr. DINA SINGER WHO MANY OF YOU I'M SURE KNOW AND IS NCI COORDINATOR FOR INTERACTIONS BETWEEN NCI AND ARPA-H. Dr. SINGER IS HAPPY TO TAKE -- DROP HER AN E-MAIL IF YOU SAY I HAVE AN IDEA THAT MIGHT FELLOWSHIP IN ARPA-H AND INVOLVE WORK THAT AND DO WITH NCI AND Dr. SINGER IS REALLY HELPING US AND MANAGE ALL OF THOSE THAT INTEREST. AND SHE'S VERY BUSY DOING THAT. SO IT'S EXCITING. WE REALLY -- WHAT WE WANT TO DO IS WHATEVER ARPA-H DEVELOPS, WE WANT TO BE THE USERS, RIGHT. WE WANT TO BE THE END USERS. THE OTHER THING I HEARD WHICH IS VERY POSITIVE IS WE'RE GOING TO BE THE TEST ENVIRONMENT. YOU KNOW, IF THEY DEVELOP SOMETHING NEW AND SEE WHETHER IT WORKS OR NOT, WE'LL BE WITH HER TO HELP ASSIST. TAKE A LOOK, IT'S THERE AND READY TO GO. >> GREAT, THANK YOU. >> Dr. Flaherty: KAREN. >> MONICA, I REALLY APPRECIATE THE FISCAL TRANSPARENCY AND THE PAYLINE AND WHAT THE OPPORTUNITY COSTS WAS THERE AND YOU KNOW, KUDOS FOR GETTING THE RPG PAYLINE TO WHAT IT IS RIGHT NOW AND LOOK FORWARD TO FURTHER DISCUSSIONS SO THANK YOU FOR THAT AND MY QUESTION HAS TO DO WITH THE REISSUANCE OF THE NATIONAL CANCER ACT AND SO I'M WONDERING IF THERE'S ANYTHING YOU CAN TELL US ABOUT PROPOSED CHANGES, ADDITIONS, ANYTHING THAT WE MIGHT EXPECT AS WE THINK TOWARDS WHAT THAT LOOKS LIKE FOR THE PATH FORWARD? >> Dr. Bertagnolli: YEAH, SO WE'RE STILL WORKING WITH THE OSTP WITH THE PRESIDENT ON WHAT A REISSUANCE WILL LOOK LIKE, YOU KNOW, I REALLY CAN'T SHARE A LOT YET OTHER THAN IT'S VERY CLEAR THAT THE PRESIDENT WANTS NCI TO HAVE ALL THE TOOLS THAT IT NEEDS TO MAKE THE FASTEST POSSIBLE PROGRESS. AND SO, NOW WE'RE WORKING ON EXACTLY WHAT THOSE TOOLS AND AUTHORITIES LOOK LIKE. AND IT'S A TOPIC THAT GOES WAY MOPPED HERE AND HOW WE DO OUR HIGHERING AND IT'S REALLY THE NUTS AND BOLTS AND NITTY GRITTY OF HOW WE GET WORK ACCOMPLISHED BUT I CAN JUST TELL YOU THAT THE PRESIDENT'S OFFICE IS BEHIND NOT PUTTING WHAT WE NEED IN THERE TO BE EFFICIENT, AND MORE NIMBLE THAN WE'VE BEEN AND MAKE GREAT PROGRESS SO WE'RE EXCITED ABOUT IT. >> ONE OF THE THINGS THAT'S REFRESHING THAT WE HEARD IN YOUR PRESENTATION THE INCLUSION OF THE FDA SO YOU GET WHERE I'M HEADED. I HOPE IT IS INCLUDED IN THIS REISSUANCE. >> Dr. Bertagnolli: I CAN TELL YOU ABSOLUTELY WHAT HAS ALREADY BEEN INCLUDED IS THE FACT THAT THE NATIONAL CANCER PLAN IS BEEN PRESENTED TO, WELL IT WILL BE TOMORROW, I BELIEVE, PRESENTED TO THE SECRETARY OF HEALTH AND HUMAN APP SERVICES AND IT'S ALREADY GONE THROUGH ALL OF HIS -- THIS IS WHY WE WONDER I'VE BEEN TALKING ABOUT THIS PLAN FOR A WHILE. WHY IS IT TAKING TIME TO DELIVER? THAT'S BECAUSE WE HAVE ENGAGEMENT AND INVESTMENT ACROSS HEALTH AND HUMAN SERVICES ACROSS NCI AND ACROSS OSTP AND YOU KNOW, SO THAT ALL OF GOVERNMENT APPROACH IS VERY MUCH GOING TO BE REFLECTED IN THE PLAN. WHICH IS KEY. WE KNOW WHAT WE NEED TO MANAGE TO AND WE'VE ALL AGREED -- YOU KNOW, WE'VE ALL SIGNED ONTO IT SO RIGHT THERE THAT'S A TREMENDOUS STEP. >> THANK YOU, THAT WAS GREAT. I WAS HEART END TO HEART ABOUT THE INCREASE IN CANCER FUNDING. THE COST OF DOING SCIENCE IS REALLY GOING UP AND ESPECIALLY BECAUSE MANY OF US ARE FACING THE ISSUE OF OUR TRAININGS NEEDING TO BE SUPPORTED WITH THE LIVING RAGE AND KA OFFERING CAL SALARY TO INDUSTRY AND WE ARE NOT BUDGETED TO REALLY MEET THOSE SALARY INCREASES AND SALARY RANGE IN GRANTS ARE OUT DATE AND SOME OF US ARE USING GRANTS FUNDED YEARS AGO WHERE THE GRANTS YOU KNOW, WHERE THE SALARY RANGING ARE NOT UP-TO-DATE SO WHAT IS NCI THINK ABOUT HOW WE CAN ADDRESS THIS AND IS THERE ANY DISCUSSION THAT NCI IS HAVING WITH CANCER CENTERS AND INSTITUTIONS ABOUT HOW WE CAN SORT OF MEET THESE DIFFERENT PRIORITIES. >> OH, BOY. WE ARE JUST SO CONCERNED AS YOU ARE ABOUT THE ISSUE OF SALARY AND YOU KNOW, AND FOR OUR TRAINEES AND ABSOLUTELY AND DO WE WANT BIGGER GRANTS OR FEWER GRANTS? IF YOU GOT BIGGER GRANTS, YOU WILL HAVE FEWER. IF YOU HAVE THE SAME GRANTS, YOU CAN HAVE MORE. IT'S THE MATH. SO, WE ARE ABSOLUTELY OPEN TO -- IF WE RAISE, WE CAN RAISE THE AMOUNT OF -- WE CAN RAISE SALARIES BUT THAT WOULD BE FEWER GRANTS OVER ALL. THE PAYLINE WILL GO DOWN. THAT'S WHAT WE'RE GOING TO BE FIGHTING. THAT'S PART OF AN ONGOING DISCUSSION WE'RE HAVING WITH THE CANCER CENTER DIRECTORS AND WE'LL HAVE A RETREAT IN MAY COMING UP AND THAT'S THE MATH. THAT'S THE ONLY TIME YOU NEED -- >> I KNOW. I GUESS ONE OF THE ISSUES IS MAYBE TO CREATE A SITUATION WHERE IN OF THE INDIVIDUAL INVESTIGATORS ARE SORT OF REQUIRED TO MEET THESE MANDATES BASED ON THE NOT INSTITUTIONAL CAN THEY MAKE SURE THERE'S A GRACE PERIOD TO MAKE SURE THESE ARE PHASED IN AS OPPOSED TO KIND OF PUT INTO PLACE WHICH MAKES IT CHALLENGES FOR INVESTIGATORS WORKING UNDER NCI GRANTS THAT ARE FUNDED YEARS AGO. >> I DON'T KNOW OF ANY CHANGES WE'RE MANDATING AT THIS POINT. IT SOUNDS LIKE IT'S DEFINITELY -- THIS IS AN ONGOING CONVERSATION. YOU WILL SEE IN THE NATIONAL CANCER PLAN AND UP WITH GOAL OF THE PLAN IS WORKFORCE. AND ALL ABOUT THIS ISSUE AND HOW WE REALLY ALL NEED TO WORK TOGETHER ON THIS ON SO MANY LEVELS. THAT'S A LONG DISCUSSION AND WE STILL HAVE SIGNIFICANT AMOUNT OF WORK TO DO WITH THE COMMUNITY TO FIGURE OUT WHAT THE RIGHT THING TO DO IT IS WE'RE VERY OSHA TO ANY KIND OF SOLUTION THAT BRINGS BENEFIT TO OUR TRAINEES. >> Dr. Flaherty: WE'RE GOING TO BE CHALLENGED FOR TIME. I'M GOING TO HONOR THE FIRST TIME SO GO AHEAD. >> THANK YOU. THIS IS GOING TO BE QUICK. MONICA, THANK YOU SO MUCH FOR THIS. I WAS REALLY INTERESTED ABOUT A CLCLINICAL TRIALS AND ALL OF GOVERNMENT MEANS ALL OF GOVERNMENT WORKS AGAIN. THE QUESTION IF YOU ARE WILLING TO SHARE IS TO WHAT EXTENT IS THIS GOING TO BE POINTED IN THE DIRECTION OF ADDRESSING REALLY THE SYSTEMIC BARRIERS TO PARTICIPATION BY PLAQUE PEOPLE, HISPANIC PEOPLE, NATIVE AMERICAN PEOPLE BECAUSE IT SEEMS TO BE REALLY IMPORTANT TEST BED OR LABORATORY FOR THIS SORT OF EXPERIMENT AND SIMPLIFY AND MAKE THEM MORE ACCESSIBLE SO MANY MORE PEOPLE NEED IT DESPERATELY CAN GET ACCESS TO LIFE SAVING THERAPIES. >> Dr. Bertagnolli: OH, YES. IT'S NOT JUST SIMPLIFIED. IT'S MEETING EVERY DIVERSE COMMUNITY WHERE THEY ARE, RIGHT. IT'S A COMPLETELY DIFFERENT SOLUTION FOR SOMEONE WHO LIVES WHERE I GREW UP, WHICH IS 100 MILES FROM ANY HOSPITAL IN A VERY RURAL LOCATION TO SOMEONE WHO LIVES ON A INDIAN RESERVATION OR A CITY WHERE THEY DON'T HAVE GOOD ACCESS TO HEALTHY FOOD. EVERY COMMUNITY NEEDS A DIFFERENT SOLUTION AND WE'VE LEARNED THAT THEY'RE NOTING COME TO US, WE NEED TO GO TO THEM. THAT'S INTER WOVEN THROUGH THE NATIONAL CANCER PLAN. YOU WILL SEE THIS THEME AND IT'S SO DIVERSE AND WE HAVE TO GO TO THEM THEY'RE NOT COMING TO US. >> Dr. Flaherty: I LOOK AT THE SECOND PAGE BUT YOU ARE ON MY FIRST PAGE SO YOU ARE UP. >> WONDERFUL. MONICA, I'M SO EXCITED NOT ONLY ABOUT THE PAYLINE WHICH WE NEED TO OF COURSE INCREASE. I'M ALWAYS IN FAVOR OF MORE GRANTS AND SMALLER GRANTS JUST AS A LITTLE VOTE. THE CLINICAL TRIALS INNOVATION UNIT SOUNDS FASCINATING AND IMPORTANT AND I HAVE JUST SOME QUESTIONS ABOUT IT. SO FIRST OF ALL, IT WILL HELP WITH INCLUSION, SIMPLIFICATION OF TRIALS AND SAVE US ALL MONEY, INCREASE EFFICIENCY AND I'M WONDERING WHETHER YOU CAN COMMENT A LITTLE BIT ON THE PROCESS OF HOW THIS IS DEVELOPED AND WHETHER THERE'S A RESEARCH COMPONENT TO IT. >> SO THE CLINICAL TRIALS INNOVATION UNIT TAKES IDEAS. THE IDEAS COME INTO THROUGH THE NATIONAL CLINICAL TRIALS NETWORKS LEADERS RIGHT NOW. THEY CAN PROPOSAL IDEAS AND YOU CAN PITCH THEM TO ANY OF THE NCTN LEADERS. THERE ARE ALSO TWO DIRECTORS OF THE CLINICAL TRIALS UNIT AND THEY'RE Dr. SHELIA PRINCIPLE DA ZEAL AND CLINICAL TRIALS AND CCT AT NCI AND MICHAEL MOORE IS WHO IS THE CO DIRECTOR AND WHEN THEY AGREE TO TAKE ON A STUDY THE CLINICAL TRIALS INNOVATION UNIT AGREES TO MAKE IT HAPPEN TO FIND THE PARTNERS AND DEAL WITH INDUSTRY AND GET IT ALL TOGETHER SO THEY'RE NOT GOING TO BE ABLE TO TAKE THAT MANY. I AM ANTICIPATING IT'S FIRST YEAR, WE'LL SEE THREE MAYBE FOUR NEW STUDIES LAUNCHED BY THE UNIT OVER VARIOUS AREAS. BUT LIKE I SAID, AS THIS HAPPENS, SOME OF THE TOOLS CAN BE MORE MAINSTREAM AND FIT INTO OUR RESEARCH AND MECHANISM. I HOPE THAT ANSWERS YOUR QUESTIONS. THE IDEA TO GO TO THE UNIT. >> VERY QUICK FOLLOW-UP, RATHER WE DO IMPLEMENTATIONS SCIENCE ON THE RESEARCH ON THE NEW METHODS THAT ARE GETTING EMPLOYED WHETHER IT'S REMOTE SENSOR OR OTHER ACTIVITIES? >> ANYTHING IS ON THE TABLE FOR THAT UNIT. THEY CAN ABSOLUTELY DO IMPLEMENTATION SCIENCE, THEY CAN DO BIOMARKER DEVELOPMENT, ANYTHING WE NEED TO REACH PATIENTS AND DO A CLINICAL RESEARCH FOR IS THERE. IT'S NOT GOING TO DO OBSERVATIONAL STUDIES RIGHT NOW. >> THANK YOU. >> Dr. Flaherty: LAST QUESTION. KAREN. >> THANK YOU, MONICA. WONDERFUL PRESENTATION. I AM ALSO GOING TO ASK JUST FOR SOME MORE VERIFICATION ABOUT THE CLINICAL TRIALS INNOVATION UNIT. SO, A LOT OF THE EXAMPLES WERE SEEMING TO FOCUS ON DEVELOPMENT OF INNOVATION AROUND TREATMENT TRIALS AND I'M CURIOUS ABOUT YOUR PERSPECTIVE ON THE PRIORITIES OF ENCORE WHICH IS A LITTLE DIFFERENT FROM THE PRIORITIES OF THE NCTN GROUPS WITH CANCER CONTROL STUDIES, SIM POM MANAGEMENT, PREVENTION STUDIES AND ALSO CANCER CARE AND DELIVERY AND ALL OF THAT AND THERE'S A LOT OF INNOVATION THAT NEEDS TO BE DONE THERE AND PARTNERING SO I'M CURIOUS ON YOUR THOUGHTS ABOUT THAT AND IS IT PART OF WHAT YOU EXPECT TO SEE? >> IF THIS HELPS, TWO IDEAS THAT ARE CURRENTLY BEING THROWN AROUND, NOT ACCEPTED YET BUT JUST GENERAL IDEAS THAT ARE OUT THERE, ONE OF THEM IS A SYMPTOM INTERVENTION STUDY THAT IS REALLY EXCITING AND IT ACTUALLY MIGHT BE A COLLABORATION WITH ONE OF THE OTHER NIH INSTITUTES EVEN WHICH IS REALLY EXCITING. AND THEN THERE'S ALSO ONE ABOUT DATA COLLECTION FOR A CLINICAL TRIAL WITH THE FDA THAT WOULD USE THE ELECTRONIC HEALTH RECORD AS THE SOURCE OF THE DATA. SO THERE'S SOME PRETTY COOL STUFF HAPPENING AND IT'S NOT JUST, IT'S NOT JUST TREATMENT. >> PERFECT. THANK YOU. >> THANK YOU, ALL. THANK YOU, MONICA. NEXT DEB LOWY IS GOING TO GIVE A PRESENTATION ENTITLED NCI RESEARCH PROJECT GRANTS BUDGET IS BEYOND. >> Dr. Lowy: THANK YOU, VERY MUCH. GOOD MORNING TO YOU. THIS IS NOT DEJA VU ALL OVER AGAIN. BUT I GAVE A SIMILAR TALK TO THE VSA A YEAR AGO BUT WE THINK THAT A FAIR AMOUNT HAS HAPPENED AND THAT IS REFLECTED, FOR EXAMPLE, IN THE VARIOUS QUESTIONS THAT YOU HAVE ALREADY ASKED MONICA AND I JUST WANT TO SAY THAT FOR ANDY CHAN'S QUESTION, WE ARE ACTUALLY DEVELOPING DATA LOOKING AT VARIOUS OPTIONS THAT THE THANK YOU FOR PUTTING THE PRESENTATION TOGETHER. THE NEXT SLIDE TELLS YOU ABOUT THE THREE AREAS THAT I PLAN TO COVER IN THE NEXT 15 MINUTES. ONE THE DISTRIBUTION OF THE APPROPRIATED THAT DEAD TO THE POLICIES THAT YOU HAVE ALREADY SEEN. THE NEXT TWO SLIDES FOCUS ON THE NCI BUDGET OVER ALL AND WHAT IS SHOWN ON THE OUTER PART ARE REALLY THE DISTRIBUTION OF THE EXTRAMURAL PARTS WHICH ARE IN VARIOUS SHADES OF BLUE AND THEN THE OTHER FUNDING THAT INCLUDES RESEARCH MANAGEMENT AND SUPPORT IN THE INTRAMURAL RESEARCH AND BASICALLY, ABOUT THREE QUARTERS OF THE FUNDING FROM NCI GOES TO EXTRAMURAL FUNDING AND ABOUT A QUARTER TO COVER THESE REALLY TWO AREAS OF INTRAMURAL RESEARCH, RESEARCH MANAGEMENT AND SUPPORT AND ALSO BUILDINGS AND FACILITIES. THE NEXT SLIDE SHOWS THE SAME AREA BUT TO HIGHLIGHT A FEW THINGS, FIRST, THE RESEARCH PROJECT GRANTS, THE RPGs REPRESENT THE SINGLE LARGEST AMOUNT OF INVESTMENT FOR THE NCI BUDGET, 44%. BUT AS SHOWN IN THE TWO BULLET POINTS ON THE RIGHT, NCI SUPPORTS A LOT OF RESEARCH AND OTHER ACTIVITIES THAT ARE OUTSIDE THE RPG POOL, MONICA HAS ALREADY ALLU ALLUDED TO SOME BUE SECOND BULLET, CANCER CENTER SUPPORT GRANTS, SPORES AND TRAINING. THE NEXT SLIDE LOOKS AT WHAT HAVE WE DONE ESSENTIALLY WITH THE $1 BILLION INCREASE THAT THE NCI HAS RECEIVED FROM 2018 THROUGH 2022. WE'RE NOT INCLUDING 2023 BECAUSE WE DON'T KNOW EXACTLY WHAT THE NUMBERS ARE GOING TO BE. ON THE LEFT, I HOPE YOU CAN APPRECIATE THAT ABOUT 53% OR ABOUT $550,000,000.1.072 MILLION HAS GONE TO THE RPG POOL AND 47% TO ANOTHER AND JUST REMIND YOU ON THE OTHER SLIDE, THAT THE RPG POOL IS 44%. SO WE'VE ALL OWE INDICATED MORE FUNDING TO THE RPG POOL THAN TO THE REST OF THE AREA. OVER THAT FOUR-YEAR PERIOD, THE PREPORTION OF THE RPG POOL HAS GONE FRIENDSHIP 41 TO 44 PERCENT AND THIS REPRESENTS AN AVERAGE OF ABOUT $140 MILLION OF THE 260 FOR THE INCREASES THAT WE'VE SEEN ON AVERAGE IN THE LAST FOUR YEARS. THE PERCENTAGE IS PROJECTED TO INCREASE FURTHER IN '23 BUT WE'RE NOT INCLUDING IT BECAUSE WE DON'T KNOW THE PRECISE AMOUNT. THE NEXT FEW SLIDES TALK ABOUT THE RPG POOL TRENDS. THE NEXT SLIDE, THERE ARE FOUR SLIDES IN THIS PART. INDICATES WHAT WE SAW ABOUT FIVE OR SIX YEARS AGO WHICH WAS THE RATE OF APPLICATIONS AND NUMBER OF APPLICANTS TO NCI WENT UP FASTER THAN THE NUMBER OF APPLICATIONS AND APPLICANTS FROM OTHER INSTITUTES AND CENTERS AND AS OF 2022, BETWEEN 2013 AND '2Y APPLICANTS IN TERMS OF THE INCREASE AND NCI AND THE NEXT SLIDE, SHOWS WHAT HAS HAPPENED REALLY OVER THE LAST COUPLE OF DECADES FOR FUNDING WITH THE RPG AND THIS IS NOT A PAYLINE, THIS IS SUCCESS RATES OKAY AND THE BLUE IS THE NIH AND THE ORANGE IS NCI. WHAT I THINK YOU WANT TO SEE AND APPRECIATE IS THAT DURING THIS TIME, THAT THERE WAS THIS SUBSTANTIAL INCREASE IN THE NUMBER OF APPLICATIONS AND OUR FUNDING OF ACTUALLY OUR SUCCESS RATES WENT DOWN AND THEY HAD GONE UP OVER THE LAST FEW YEARS BUT NOT AS HIGH AS NIH PART OF THAT IS ACCOUNTED FOR BECAUSE WE SUPPORT RESEARCH OUTSIDE OF THE RPG AREA WHERE THE RPG PORTION ACCOUNTS FOR A SUBSTANTIALLY HIGHER PERCENTAGE FOR MANY OTHER INSTITUTES AND CENTERS. SO THIS SLIDE DEPICTS WHAT HAPPENED FOR EARLY STAGE INVESTIGATORS AND IN THE GREEN OR THE TOTAL NUMBER OF AWARDS THAT WERE MADE EACH YEAR TO THE EARLY STAGE INVESTIGATORS AND IN BLUE, THE PAYLINE FOR THE AEROMEXICO STAGE INVESTIGATORS FOR EACH OF THE YEARS. I HAVE OUTLINED IN THE RED RECTANGLE, 2019 BECAUSE I WANT YOU HAD TO USE THAT AS A REFERENCE POINT FOR THE EXPERIENCED INVESTIGATORS THAT YOU WILL SEE ON THE NEXT SLIDE. BUT BEFORE WE GO THERE, THE NUMBER OF AWARDS THAT WE'VE BEEN ABLE TO MAKE TO AEROMEXICO STAGE INVESTIGATORS HAS REALLY GONE UP SUBSTANTIALLY SINCE THE 2016 AND 2017 AREA GOING FROM THE 80s TO THE 130s. THE NEXT SLIDE SHOWS YOU WITH EXPERIENCED INVESTIGATORS, THAT THE NUMBER OF AWARDS THAT WE'VE BEEN ABLE TO MAKE HAS GONE UP AGAIN PARTICULARLY SINCE 2019 WHEN WE HAD THIS LOW PAYLINE OF 8% AND THAT YEAR WE ACTUALLY THE ESIs WERE 6 PERCENTAGE POINT HIGHER FOR THE SWEPT YEARS IT'S BEEN 5% POINTS HIGHER AND AS MONICA POINTED OUT, WE ANTICIPATE A SUB T SUBSTANTIAL INCREASE IN THE TOTAL NUMBER OF AWARDS IN 2023 BUT WE DON'T KNOW THE NUMBERS BECAUSE WE'RE STILL REALLY JUST THE FIRST HALF OF THE FISCAL YEAR. I NOW HAVE FIVE SLIDES FOR CONSIDERATION OF FY23. THE FIRST SLIDE IS BASICALLY WHAT YOU HAVE SEEN ALREADY FROM MONICA'S PRESENTATION WHERE THE ESTABLISHED INVESTIGATORS OF THE 12% EARLY STAGE INVESTIGATORS, 17th% AND SHE DIDN'T MENTION BUT THE R21s NINTH PERCENTILE AND THE COMPETING GRANTS AT 98% SO LET'S GO THROUGH THIS TO TRY TO UNDERSTAND BETTER HOW WE GOT THERE. NEXT SLIDE. SO, EACH YEAR, THIS ARE TWO OVER ALL INVESTMENT CATEGORIES WITHIN THE RPG POOL. THE COMPETING AWARDS ORCHARD REFOR THE NEWAWARDS AND THE SECE NON COMPETING AWARDS OR THE OUT-YEAR AWARDS. TO PRIORITIZE FUNDING MORE NEW AWARDS, WE GENERALLY FUND ONLY THE FIRST YEAR OF THE AWARDS WHEN THEY ARE MADE, HOWEVER, THEY'RE MORE THAN ONE YEAR. THE R56 AWARDS ARE NOTABLE EXCEPTION JUST ONE YEAR BUT MOSTLY THE VAST MAJORITY ARE MORE THAN ONE YEAR AND THE AVERAGE LENGTH IS FIVE YEARS AND GO THROUGH SOME OF THE IMPLICATIONS OF THAT. NEXT SLIDE. WE HAVE TWO MAIN FUNDING SOURCES FOR THE RPG POOL. ONE IS THE TURNOVER FUNDS FROM THE NON COMPETING RPG AWARDS THAT WERE COMPLETED IN THE. PRIOR YEAR. IF EVERYTHING WERE AT STUDY STATE THAT WOULD BE SUFFICIENT. THAT'S NOT SUFFICIENT AND SO WE NEED TO AT FUNDS FROM THE NCI APPROPRIATION BECAUSE TURNOVER DOLLARS ARE INSUFFICIENT. THE THE AVERAGE COST OF EACH COMPETING AWARD WILL BE HIGHER THAN THE COST OF EACH COMPLETED AWARD. AND THIRD, THE OUT YEAR COST OF MULTI-YEAR AWARDS. MONICA SHOWED YOU THE STAIR STEP NOTION THAT WE NEED TO ADD MORE FUNDING EACH YEAR IN ORDER TO COVER THE OUT YEAR COST. I NOW WANT TO GO TO THE NON COMPETING AWARDS. WHY MIGHT WE FUND THEM AT LESS THAN 100% OF THE COMMITMENT LEVEL? THE FIRST BULLET TELLS YOU NCI CONSIDERS THIS OPTION WHEN THE FUNDS FROM TURNOVER COMPLETED AWARDS PLUS FROM NCI APPROPRIATIONS ARE I AM SUFFICINSUFFICIENT.IT'S WHETHERS THAT IS HAVING A HIGHER PAYLINE OR TO PRIORITIZE FUNDING NON COMPETING GRANTS AND ARE 100% AND WE'VE CONSULTED WITH YOU AND NCAB IN THE PAST AND WE ARE USUALLY PRIORITIZING FUNDING MORE COMPETING AWARDS BECAUSE THAT SEEMS TO BE THE SENSE OF THE COMMUNITY. NEXT SLIDE. THESE ARE SOME COLLAR DOLLAR CONSIDERATIONS. THE RPG PEOPLE AT THE END OF 2022, WAS $2.89 BILLION. THE RO1s MAKE UP 60% OF THE TOTAL RPG POOL. EACH TIME WE INCREASE OR DECREASE THE PAYLINE BY A PERCENTILE POINT, WE ARE ADDING OR SUBTRACTING ABOUT $33 MILLION. AND WHEN WE ARE LOOKING AT THE NON COMPETING PERCENTILE, THAT PERCENT IS $21 MILLION SO THESE VARIOUS CONSIDERATIONS ARE WHAT LEAD US TO MAKE THE DECISIONS. THE FINAL SLIDE, REALLY IS THE SUMMARY. FIRST, NCI HAS PRIOR TASED RPG FUNDING ABOUT $550 MILLION HAS BEEN ADDED TO THE RPG POOL DURING THE FOUR YEARS BETWEEN 2018 AND '22. EXTRAMURAL FUNDING RESEARCH LIES OUTSIDE THE RPG POOL AND NCI HAS NOT NEGLECTED THE OTHER PARTS OF THIS RESEARCH PORTFOLIO. THANK YOU VERY MUCH AND I THINK WE HAVE A FEW MINUTES FOR QUESTIONS AND COMMENTS. >> Dr. Flaherty: THANK YOU, DOUG. QUESTIONS? >> THANK YOU, DOUG. COULD YOU COMMENT MORE ABOUT THE DENOMINAT OR AND THE NUMBER OF APPLICATIONS COMING TO THE NCI? >> Dr. Lowy: THE NUMBER? >> YEAH. >> Dr. Lowy: WE GET, I HOPE I'M CORRECT, WE GET AROUND 3500 APPLICATIONS EACH YEAR THE SUCCESS RATE IS ABOUT 14% AND SO THE SUCCESS RATE FOR RPGs IS WE GET ABOUT 800 SO PROBABLY ABOUT 400,000 TO 5,000 APPLICATIONS. >> I MEANT THE TRENDS AND HOW IT COMPARES TO THE OTHER INSTITUTES? >> Dr. Lowy: I'M SORRY, BOB, THE TRENDS ARE THAT HOURS HAVE BEEN FLAT FOR THE LAST COUPLE OF YEARS. WE CAN SEE THE INTERPRETED WHEN WE LOOK AT THE RELEVANT SLIDE. >> YOU HAVE A COMMENT? >> YES, THANK YOU, DOUG. I WAS JUST CURE BUS THE R37 GRANTS. IT MAY BE TOO EARLY TO SEE WHAT THE IMPACT IS INTENSE ON FUNDING BUT ONE -- THAT -- >> THAT'S A VERY IMPORTANT QUESTION. WE INSTITUTED THAT POLICY A NUMBER OF YEARS AGO BECAUSE WE WANTED EARLY STAGE INVESTIGATORS TO HAVE AN EVEN GREATER OPPORTUNITY TO TRY TO MAKE AN IMPACT WITH THEIR FIRST AWARD. AND WHAT HAPPENS IS THAT IT'S NOT AUTOMATIC THAT EVER FIVE YEARS THAT THEY GO TO THE EXTRA TWO YEARS. THEY WRITE A PROGRESS REPORT AND THEN ENCLOSED SESSION AND I'M PLEASED TO TELL YOU THAT THE PROBLEM THAT THE VAST MAJORITY OF THE PEOPLE WHO ARE ELIGIBLE THUS FAR FOR THE R37, THEIR PROGRESS HAS THEY'RE GERMANE TO THIS STATISTIC THAT YOU QUOTED -- I DID NOT APPRECIATE, YOU CHANGED THE FUNDING LINE BY ONE POINT OR ONE PERCENT YOU SAID AND IT'S SEVERAL BILLION DOLLARS OF EFFECT, IF I REMEMBER THAT SLIDE. THAT TO ME WAS EYE-OPENING AND I WAS SITTING HERE TRYING TO THINK OF HOW THAT CAN POSSIBLY BE SO IF IT'S 1%, OF 3,500 GRANTS WHICH IS WHAT THE ANSWER WAS TO BOB'S QUESTION, THAT WOULD ONLY BE 35 GRANTS. SO UNDERSTANDING THAT THE LINK BETWEEN THE 1% AND THE 3 BILLION WOULD BE EYE-OPENING. IT IS CERTAINLY A SHOCKING STATISTIC. >> Dr. Lowy: YEAH. SO, THE THE NEW AWARDS THAT WE MAKE EACH YEAR, ABOUT 60% OF THEM ARE RO1 OR RO1 AWARDS. AND THE 33 MILLION IS REALLY FOR EACH PERCENT STYLE SO IF WE'RE AT, TO USE AN EASY NUMBER AND THAT WOULD BE IT'S NOT THAT EACH PERCENTILE IS NOT BUT THAT'S WHAT IT COMES DOWN TO SO THIS -- YOU KNOW, BASICALLY, FOR THE 12%, YOU ARE TALKING ABOUT $66 MILLION PLUS THE 300 SO IN ROUND FIGURES IT'S $400 MILLION IN NEW RO1 AWARDS. >> THANK YOU, IT'S A STRIKING STATISTIC. >> BUT WHAT IS EQUALLY IMPORTANT IS THE NUMBER OF INCREDIBLY OUTSTANDING APPLICATIONS THAT WE CAN'T FUND. AT 129% THEY WERE JUST SO MANY HOW DO YOU DIS TICK WISH AND TO BE POSITIVE I'VE QUOTED SUCCESS RATE OF 13% AND I THINK -- >> THIS IS FOR ALL AWARDS. THIS IS NOT JUST THE RO1s. >> YEAH. >> 10% OF RO1s WERE 14% I BELIEVE LAST YEAR. SHERRI, THIS NEEDS TO BE THE LAST QUESTION, I'M SORRY. >> Dr. Flaherty: THANK YOU. ASK YOUR QUESTION. >> I DID. I SAID THAT YOU CLOSED THE GAP. >> Dr. Lowy: OH, I'M SORRY. >> AND NOW IT'S JUST 15 AND 21 SO WE ARE MOVING IN THE RIGHT DIRECTION. >> Dr. Lowy: YEAH. KEITH, BACK TO YOU. >> Dr. Flaherty: THANK YOU, DOUG. NOW, ON TO THE LEGISLATIVE REPORT. M.K. HOLOHAN. >> Ms. Holohan: YOU HAVE IF QUESTIONS THAT I DON'T COVER HERE OR WE DON'T HAVE TIME TO GET TO QUESTIONS, PLEASE REACH OUT TO ME AND WE'RE HAPPY TO TALK WITH YOU OR YOUR STAFF. NEXT SLIDE, PLEASE. I'M GOING TO TOUCH ON THESE FOUR TOPICS TODAY. THE DEBT LIMIT AND BUDGET NEGOTIATIONS THAT JUST RELEASED PRESIDENT'S BUDGET REQUEST FOR FISCAL YEAR 2024 AND IT TEES OFF THE CONGRESSIONAL APPROPRIATIONS PROCESS AND THEN A WORD ABOUT OVERSIGHT IN THIS 118 118th CONGRESS. NEXT SLIDE, PLEASE. SO THE DEBT CEILING GAME OF CHICKEN BEGINS. SO, DEBT LIMIT INCREASES ARE ROUTINE. THEY PASS IN ALL SORTS OF ADMINISTRATIONS RND ADMINISTRATIONS AND THEY DO BECOME LEVERAGE FOR DEAL-MAKING. THE URGENCY OF A DEBT LIMIT. AND THE IMPENDING X DATE OF THE TREASURY REFERS TO IT IT SERVING AS LEVERAGE AND CREATES URGENCY AND THERE'S BEEN -- A DEBT LIMIT INCREASE HAS BEEN PART OF THE CALCULATIONS FOR MOST OF THE THE BIG BUDGET DEALS WE'VE SEEN IN THE MODERN HISTORY OF THE CONGRESS AND THE BUDGET CONTROL ACT OF 2011 THAT SETS SPENDING CAPS FOR 10 YEARS. THIS WERE LOTS OF OTHER CONDITIONS, SOME INVOLVED PROCESS AND UNDERSTANDABLY MANY MEMBERS HAVE BEEN FRUSTRATED ABOUT ONLY GETTING TO SEE THESE HUGE OMNIBUS BILLS. UP WITH OF THE PROBLEMS THAT WAS GOING TO BE THAT THEY DON'T MOVE 12 BILLS THROUGH FOR EACH SUBCOMMITTEE SEPARATELY AND THAT JUST TAKES A LOT OF TIME. WE'LL GO TO THE NEXT SLIDE, PLEASE. SO, THE PRESIDENT RELEASED HIS FY24 BUDGET REQUEST LAST WEEK AND THIS WAS A BIT LATER THAN NORMAL USUALLY IT'S A MONDAY AND FIRST MONDAY IN FEBRUARY AND COME RIGHT AFTER THE STATE OF THE UNION AND FY23 WASN'T COMPLETED UNTIL THE END OF THE CALENDER YEAR SO SINCE BLEE THERE NEEDED TO BE MORE TIME AND DEVELOPING THE BUDGET REQUEST AND SO UP WITH OF THE THINGS THAT WE SEE HERE ARE THE BUDGET REALLY SHOWCASE AND YOU'VE HEARD PRESIDENT BIDEN SAY THIS, DON'T TELL ME WHAT YOU VALUE SHOW ME YOUR BUDGET THAT TELLS ME WHAT YOU VALUE WHAT THIS BUDGET CALLS FOR NEW INVESTMENT IN CLEAN ENERGY AND CLIMATE SCIENCE AND NEW TECHNOLOGIES. A LOT OF IT IS PAID FOR BY TAX INCREASES ON THE WEALTHIEST AMERICANS AND CORPORATIONS AND TAX CREDIT ROLL BACKS AND SOME OF THE BUDGET PROVISIONS AND ANTICIPATE SAVINGS FROM NEGOTIATING PRESCRIPTION DRUG PRICES AND SO AS YOU WOULD EXPECT, THEY'RE IMMEDIATE IDEOLOGICAL CLASHES. HOUSE REPUBLICANS HAVE RULED OUT ANY NEW TAXES AS A SOLUTION TO THE FEDERAL DEBT, MUCH LESS IN A NEW BUDGET PROPOSAL. THIS BUDGE WET PROPOSE A 3.2% INCREASE FOR DEFENSE THAT NUMBER IS NOT GOING TO BE ACCEPTABLE TO REPUBLICANS. ONE THING WORTH CONSIDERING, WHEN LOOKING AT THE IT WOULD BE AN 8% CU 8 CUT WITH FY '23 AND S NOT THAT ONEROUS. IF YOU TAKE OUT VETERANS PROGRAMS AND DEFENSE, WHICH THEY WOULD NOT CUT, YOU ARE LOOKING AT A 22% CUT WITH ALL THE DISCRETIONARY SPENDING AND THAT'S VERY SIGNIFICANT. SO, THAT SORT OF THE FRAMEWORK AND THE MIND SET IN WHICH THIS PRESIDENT'S BUDGET PROPOSAL IS BEING RECEIVED. ONE PART OF THIS BUDGET THAT THE PRESIDENT HAS MADE VERY CLEAR IS THAT HE WANTS TO PROPOSE A UNITY AGENDA PROGRAMS SORT OF SELECT PIECES OF THE BUDGET REQUEST THAT COULD HAVE BIPARTISAN SUPPORT AND THE CANCER MOONSHOT AND THE GOAL OF REDUCING CANCER DEATHS BY 50% IN 25 YEARS IS ONE ASPECT AND ANOTHER IS MENTAL HEALTH INVESTMENTS AND VETERAN PROGRAMS AND INVESTMENTS INTO OPIOID DEPOSIT EPIDEMIC. SO LOOKING AT THE PAST TWO YEARS, WHAT YOU CAN SEE HERE IS SORT OF THE NUMBERS THAT HAVE BEEN PUT FOURTH FOR NCI AND NIH OVER ALL AND ARPA-H. THIS IS NEW AGENCY WHICH NOW SITS WITHIN NIH THAT O CH COULDF THERE'S AUTHORIZATION LEGISLATION THAT CHANGES WHERE IT SITS BUT THAT'S WHERE ARPA-H IS. AND I HAVE THEIR NUMBER SEVEN RAT BECAUSE IT'S INTERESTING TO SEE THE PROPOSED GROWTH OF THAT AGENCY. AND SO WHAT WE CAN SEE FOR FY2024 IS FOR NCI THE PROPOSAL WOULD CONTINUE THE $216 MILLION THAT WE'RE RECEIVING FY2 FOR THE CANCER MOONSHOT SO TAKEAWAY THAT FUNDING CLIFF FOR NEXT FISCAL YEAR AND IT PROPOSES AN ADDITIONAL $500 MILLION FOR CANCER MOONSHOT ACTIVITIES AND SO THIS IS SORT OF THE SECOND VERSION OF THE CANCER MOONSHOT. AND THAT THIS WOULD BE ALL OF GOVERNMENT APPROACH THAT Dr. BERTAGNOLLI DESCRIBED IN HER PRESENTATION. THE OVER ALL INCREASE IS 1% INCLUDING THE MONEY THAT'S BEEN PROPOSED FOR NCI CANCER MOONSHOT AND ARPA-H THERE'S ANOTHER BILLION DOLLARS PROPOSED ANOTHER THING THE PRESIDENT'S BUDGET PROPOSES AND NOW THE PRESIDENT'S BUDGET IS AT ITS CORE A PROPOSAL FOR DISCRETION FUNDING FOR THE COMING FISCAL YEAR AND IT'S ALSO A MESSAGING DOCUMENT AND IT GOES IN MANY OF THE PROTECTIONS THAT INCLUDES SOME OF THEIR DEBT REDUCTION AND SOME OF THEM ARE ABOUT INVESTMENTS IN BROAD PROGRAMS AND SO THIS THIS PROPOSES MAPPED TORI FUNDING FOR THE CANCER MOONSHOT FOR FY25 AND AND HOWEVER, REAUTHORIZATION SORT OF SUGGESTS OR IMPLIES THAT SOMETHING A BILL NEEDS TO BE IT IS FOR EXAMPLE FDA USER FEE LEGISLATION AND IT'S MUSS PASS LEDGETATLEDGETATION SO WHAT WE'E LOOKING AT REAUTHORIZATION OF THE NATIONAL NOT APPROPRIATORS AND MIGHT INCLUDE A SPECIFIC SECTOR FOR THE NATIONAL CANCER ACT THAT MIGHT INCLUDE OTHER SECTIONS RELATED TO BIO MEDICAL RESEARCH AND IT COULD BE NIH AND FDA AND IT COULD BE CDC AND LOTS OF DIFFERENT PIECES AND COULD BE ROLE INTO THAT. ONE OF THE THINGS THAT I WANT TODAY MAKE A POINT OF IS WHAT WE REALLY HAVE SEEN IN THIS BUDGET PROPOSAL IS THAT THE CANCER MOONSHOT, AS ENVISIONED BY THE ADMINISTRATION IS NOT LIMITED TO JUST NCI. AS Dr. BERTAGNOLLI EXPLAINED, THIS IS PERCEIVED AS AN ALL OF GOVERNMENT APPROACH WITH LOTS OF COLLABORATION AND I JUST PULLED A FEW EXAMPLES HERE. THESE WERE KIND OF WITHIN EACH OF THESE DIFFERENT AGENCIES, BUDGET SECTIONS AND SO YOU CAN SEE THIS 716 MILLION BEING PROPOSED FOR NCI AND THERE'S 20 MILLION FOR HER SA, 180 MILLION FOR THE INDIAN HEALTH SERVICE AND 70 MILLION FOR IMPLEMENTATION OF THE PACKED ACT AND $15 MILLION FOR CDC AND FOR SOME SCREENING AND SO ON AND ANOTHER THING THAT WE SAW IN THIS BUDGET REQUEST WHICH IS NEW, IS A PROPOSAL TO ELIMINATE HEPATITIS C AND A MAJOR RISK FACT OR FOR LIVER CANCER AND THAT IS FOR MANDATORY FUNDING SO THERE'S GOING TO BE A TALL HURDLE THERE. THIS IS SOMETHING NCI HAS BEEN PAYING ATTENTION TO FOR MANY YEARS AND EXPLORING FOR MANY YEARS SO WE'RE PLEASED TO SEE THE ATTENTION TO THIS IDEA OF PREVENTING LIVER CANCER WITH HEPATITIS C TREATMENT. >> REGARDLESS OF SORT OF THE MID RECEPTION IT'S EXCITING TO SEE FRESH APPROACH AND CANCER RESEARCH FOR OUR COMMUNITY. NEXT SLIDE, PLEASE. AND I WAS GOING TO SAY TOO, EVEN WHEN THE PRESIDENT AND THE CHAMBERS OF CONGRESS ARE THE SAME PARTY WE NEVER SEE CONGRESS APPROPRIATING EXACTLY WHAT THE PRESIDENT REQUESTS. APPROPRIATORS TAKE THEIR JOBS VERY SERIOUSLY AND THEY TEND TO BE A LESS PARTISAN GROUP THAN I THINK I COMMENTED IN ONE OF THE LAST BOARD MEETINGS THAT THEY'RE APP OLD SAYING IN D.C. THAT THERE'S DEMOCRATS, REPUBLICANS AND APPROPRIATORS. TO THE EXTENT IT'S TRUE IN ALL GOVERNMENT AGENCIES. THIS SLIDE SHOWS THE TWO LEADERS OF THE HOUSE PRO PRE AIGS COMMITTEE AND THEY ARE SEASON VETERANS AND LONG TIME COLLEAGUES AND THEY HAVE A LOT OF RESPECT FOR ONE ANOTHER. THEY HAVE A TOUGH JOB. YOU MAY KNOW ON THE SENATE SIDE, THERE ARE ANOTHER TWO SET OF LONG TIME COLLEAGUES WHO ARE BOTH WOMEN AS WELL WHO ARE IN CHARGE OF THE SENATE APPROPRIATIONS COMMITTEE. SENATOR PATTY MURRAY OF WASHINGTON STATE AND SUSAN COLLINS OF MAIN AND TH OF MAINE. THIS IS THE FIRST TIME THEY'VE BEEN WOMEN AND THEY HAVE BEEN HAPPENED A VERY DIFFICULT TASK FOR FY24 AND I WISH THAT THIS GROUP HAD A LITTLE BIT MORE BREATHING ROOM WITH WHAT THEY'RE TRYING TO DO AND I WANTED TO SHOW YOU IN THIS SLIDE, KAY GRANGER, THE CHAIR OF THE APPROPRIATIONS COMMITTEE HAS BEEN CLEAR-CUTTING DEFENSE WON'T HAPPEN WHEN SHE'S THE CHAIR OF APPROPRIATIONS AND CONGRESSWOMAN, THE RANKING MEMBER, HAS MADE THE COMMENT ABOUT THIS DEAL TO RETURN TO FY22 LEVELS AND YOU CAN PASS PRO PRE ALLEGATIONS BILLS IN THAT WAY. THE PRESIDENT WON'T SIGN THEM AND THEY'RE NOT GOING TO GET THROUGH COMMITTEE AND SHE MADE THESE COMMENTS FAIRLY EARLY SAYING IF YOU INSIST ON THIS AND PROCEED WITH THAT GOAL, YOU WILL BE LOOKING AT A SHUT DOWN. WE'LL GET TO PREDICTION THIS IS A MOMENT. I WANT TODAY POINT OUT THAT CHAIRMAN GRANGER ACTUALLY HAS A VERY DIFFICULT TASK BECAUSE AMONG THE CONCESSIONS THAT WERE MADE BY SPEAKER McCARTHY, EARLIER ON AS HE WAS TRYING TO GET VOTES TO BE SPEAKER, HE AGREED TO AN OPEN AMENDMENT PROCESS AND THAT'S A LINT OF PROCEDURAL DETAILS THAT IS ONLY IMPORTANT FOR OUR CONVERSATIONS IN THAT USUALLY LEGISLATION IS CONSIDERED IN THE HOUSE UNDER A CLOSED RULE. SO YOU CANNOT HAVE EVERY MEMBER OF THE HOUSE OFFERING AMENDMENTS TO A PIECE OF LEGISLATION IN SOME WAYS, SOMETIMES PEOPLE WANT TO OFFER AMENDMENTS TO MAKE THEIR OWN POINT TO FORCE THEIR COLLEAGUES TO TAKE A VOTE ON SOMETHING AND DEMOCRATS HAD AN OPEN PROCESS BACK IN THE -- I KNOW IT WAS -- IT ENDED IN 2009 WHEN THEY GAVE UP ON IT BECAUSE IT JUST TOOK WAY TOO MUCH TIME. SO IF YOU ARE GOING TO BE ON THE HOUSE FLOOR WITH THE BILL AND YOU HAVE OPEN AMENDMENTS AND OPEN RULE PROCESS YOU WILL SPENE TO GET THE BILL THROUGH THE RULE COMMITTEE AND THROUGH THE HOUSE. THAT'S GOING TO MAKE CONGRESSWOMAN, CHAIRWOMAN GRANGER'S JOB MUCH MORE DIFFICULT MOVING THESE BILLS, ESPECIALLY SINCE HER KOUAKOU HEO CUT $150 BILLION THROUGH THE LEVELS. SHE KNOWS THE GOP COLLEAGUES AND THE PRESIDENT AS COPYING RECEIPT WOMAN DELAURO POINTS OUT THE GOVERNMENT WON'T SIGN A BILL LIKE THAT. THIS IS A TOUGH JOB FOR THESE TWO LEADERS. I WANTED TO POINT OUT THAT WE ACTUALLY HAVE NEW LEADERSHIP IN THE SENATE LEADERSHIP HHS SUBCOMMITTEE AND WE HAVE WE WE COVERED THE NEW CHAIR IS ROBERT ADDERHOLT FROM ALABAMA HE WAS CHAIR OF THE THE AG SUBCOMMITTEE AND LONG TIME EXPERIENCES APPROPRIATOR AND CONGRESSWOMAN DELAURO WAS THE RANKING POSITION AND THEY KNOW EACH OTHER VERY WELL FROM SERVED ON THE AG COMMITTEE AND BEEN ON CONGRESS FOR YEARS AND YEARS TOGETHER. ON THE SENATE SIDE, SENATOR ROY BANKBLUNT RETIRED AND THE RANKIG MEMBER IS SHELLY MOORE CAPITO AND TAMMY BALDWIN MOVED UP TO SHARE THE CHAIR AND WAS NOT GOING TO BE KEEP THIS SUBCOMMITTEE GAVEL AS WELL. SO THESE TWO MEMBERS, THESE TWO SENATORS HAVE BOTH BEEN REALLY STRONG SUPPORTERS OF BIOMEDICAL RESEARCH AND BOTH HAVE VISITED NCI IN RESENT YEARS AND SENATOR CAPITO HAS BEEN A BIG SUPPORTER OF CHILDHOOD CANCER RESEARCH SO WE'RE PLEASED TO BE HAVING THESE LEADERS IN POSITIONS WORKING WITH THEM AND THERE'S A FEW NEW MEMBERS ON THE SUBCOMMITTEE ON THE REPUBLICAN SIDE AS WELL. SO IN TERMS OF WHAT IS GOING TO HAPPEN NEXT, THERE ARE BUDGET HEARINGS HAPPENING AT A REALLY FAST PACE RIGHT NOW. SECRETARY VA SER A HAS HEARINGS THIS WEEK AND THE OMB DIRECTOR YOUNG HAS BEEN ATTENDING CONGRESSIONAL HEARINGS. WE'LL SEE ALL THE SECRETARY CABINET LEVEL HEARINGS HAPPENING AT FIRST. TIME IS VERY TIGHT SO THERE MAY NOT BE THE SAME NUMBER OF HEARINGS AS WE HAVE SEEN IN RESENT YEARS. YOU KNOW, WE NEVER EXPECTED FUNDING BILLS TO BE ENACTED BEFORE THE START OF THE FISCAL YEAR AND WHEN IT HAS HAPPENED ONCE IN RESENT YEARS, I THINK IT WAS Dr. SHARPLESS' FIRST YEAR AS DIRECTOR AND HE WAS SURPRISED WHEN OUR BILL WAS COMBINED WITH DEFENSE AND THEY BOTH WENT INTO WERE ENACTED BEFORE THE START OF THE FISCAL YEAR BUT THAT HADN'T HAPPENED FOR DECADES BEFORE AND IT HASN'T HAPPENED SINCE. WE SORT OF EXPECT CONTINUING RESOLUTIONS. WE REALLY DON'T KNOW HOW LONG. THERE'S BEEN SOME REPORTING THAT THERE MAY BE SOME SHORT TERM DEBT LIMIT INCREASES IN ORDER TO BUY MORE TIME FOR THE APPROPRIATIONS PROCESS TO PLAY OUT SO THEY'RE NOT GOING TO BE UP AGAINST A WALL FOR BOTH DEBT LIMIT VOTE AND CONTINUE RESOLUTION TO KEEP THE GOVERNMENT OPEN. WE REALLY DON'T KNOW WHAT WILL HAPPEN. YOU WILL HEAR A LOT OF DIRE PREDICTIONS ABOUT THE SHUT DOWNS AND FULL UCRs. YOU KNOW, DEFENSE HAS NEVER HAD A FULL YEAR RC BECAUSE THERE'S ALWAYS BEEN AN JUSTMENT OF SOME KIND TO ALLOW THEM TO HAVE AN INCREASE AND THERE'S COMBINATIONS WE CAN SEE HAPPENING. THERE COULD BE AN OMNIBUS SPENDING BILL THAT KEEPS ACCOUNTS AND AGENCIES FLAT FUNDED LIKE A CR WOULD. THAT DOES INCREASE FOR CERTAIN PROGRAMS. OBVIOUSLY WE WOULD BE HOPING CANCER RESEARCH WOULD BE ONE OF THOSE PROGRAMS THAT COULD BE SUPPORTED BY BOTH PARTIES AND DEFENSE AND WE HAVE TO GET SORT OF INCREASED REQUESTED IN THE BUDGET PROPOSAL IF THIS IS GOING TO GET BIPARTISAN SUPPORT AND WE REALLY WHAT IS GOING TO HAPPEN FROM THIS IS MUCH AS THE ADMINISTRATION AND NEVER WANTS TO ANY ADMINISTRATION NEVER WANTS TO NEGOTIATE. JUST A QUICK WORD ABOUT OVERSIGHT AND YOU MAY HAVE SEEN REPORTING, THIS WAS A HEARING EARLY FEBRUARY. Dr. TABAK AND CDC AND FDA LEADERSHIP TESTIFIED AT A HEARING THAT ENERGY AND COMMERCE HELD ABOUT THE FEDERAL RESPONSE TO COVID AND WE SAW ANOTHER HEARING MAYBE TWO WEEKS AGO AND THE COMMITTEE ON OVERSIGHT AND ACCOUNTABILITY AND THESE ARE BOTH HOUSE COMMITTEES ABOUT THE ORIGINS OF THE NOVEL SARS-CoV-2 VIRUS AND LAB LEAKS VERSUS OTHER SORT OF IDEOLOGY. THIS IS NOT AND THIS IS BEEN SOME AND THEY WERE PUSHED AND THERE WAS A THAT COULD BE DONE AND THE FEDERAL AGENCIES AND IN THE EXTREME CIRCUMSTANCES THEY WERE FACING AND OTHER THINGS THAT HAVE LED IF THERE'S AUTHORIZATION LAW DEVELOP THAT WOULD TOUCH ON THE HEALTH SECTOR AND IN A CURES REAUTHORIZATION OF THE CURES ACT, THERE MAY BE SOME SORT OF CODIFICATION OF OVERSIGHT PRE VISION THIS IS THAT AND NOT NECESSARILY NEW AUTHORITIES BUT JUST RESTATEMENT OF KIND OF THE OVERSIGHT RESPONSIBILITIES AND MAYBE REPORTING. WE MUCH SEE THAT SORT OF THING. THIS IS MY LAST SLIDE. >> THANK YOU FOR THE UPDATES. I GUESS I WAS CURIOUS GOING BACK TO THE EARLIER CONVERSATIONS AROUND LABEL COST AND HOW BEST FACTORING INTO THE BUDGET AND THEY MAY SAY IN THIS SIDE BAR. >> I'M NOT SURE I UNDERSTAND THE QUESTION. >> THE LABOR COSTS ARE ALL-TIME HIGH AND INFLATION IS A BIG ISSUE AND I GUESS GOING BACK TO THE QUESTION ABOUT THE PRESSURES AND RESEARCH ENVIRONMENTS AND IT'S NOT GOING TO BE ME IN FRONT OF THIS PROCESS. SO, I JUST WAS CURIOUS ABOUT HOW CONSIDERATIONS ABOUT THE COST INFLATION THAT CAN FACTOR INTO THIS OVER ALL THEATER AS I CALLED IT. ON A FEDERAL BUDGETING PROCESS. >> I MEAN, YOU WILL ABSOLUTELY HEAR IN HEARINGS MEMBERS AND SO THERE'S PUBLIC WITNESSES OPPORTUNITIES IN THESE HEARINGS AS WELL AS THE AGENCY HEARINGS THAT CERTAINLY SOMETHING THAT'S ADDRESSED. WE SORT OF ACKNOWLEDGE AND REQUEST FUNDING TO COVER THE COST OF INFLATION. WE RARELY GET IT. BUT TO THE EXTENT THE ACADEMIC RESEARCH COMMUNITY CAN COME TOGETHER AND MAKE THOSE POINTS IN A ORGANIZED WAY IN A SORT OF UNIFIED WAY, THAT'S VERY HELPFUL. MEMBERS AND IS SUBCOMMITTEE STAFF WANT TO HEAR FROM PROFESSIONAL GROUPS WHO CAN SAY, HERE IS WHAT YOU MIGHT NOT UNDERSTAND. THEY'RE LOOKING AT WHAT WAS THE SUCCESS RATE AND THE FUNDS THAT GIVE US AND IN WAYS THAT WE CAN SEE DELIVERABLES AND METRICS. IT'S MEANINGFUL COMING FROM RESEARCHERS THEMSELVES. >> SEEING NO OTHER HANDS. THANK YOU SO MUCH M.K. NEXT WE HAVE SCIENTIFIC PRESENTATIONS FROM JIM DOROSHOW. JIM AS YOU KNOW IS THE NCI DEPOSIT YOU TREE DIRECTOR AND DIRECTOR OF DIVISION CANCER TREATMENT AND DIAGNOSIS. JIM, ALL YOURS. >> THANK YOU, VERY MUCH, KEITH. IT'S TIMELY GIVEN THAT IT'S JUST THREE YEARS SINCE ALL OF US STARTED TO CONFRONT THE ISSUE OF THE PANDEMIC AND OUR CLINICAL RESEARCH INFRASTRUCTURE TO REVIEW SOME OF THE THINGS THAT HAPPENED AND SOME OF OUR RESPONSES TO THOSE THINGS. AND HOW WE VIEW THE FUTURE. NEXT SLIDE. SO MY OVERVIEW REALLY IS TO TALK ABOUT THE ON GOING EFFORTS TO DEAL WITH THE EFFECTS OF THE PANDEMIC ON CLINICAL CANCER RESEARCH. TO TALK A LITTLE BIT ABOUT OUR 2030 STRATEGIC VISION FOR CLINICAL TRIALS AND THEN TO TALK ABOUT AND HOPEFULLY TALK WITH YOU ABOUT ACTIVITIES TO' MILL RATE THE CURRENT CLINICAL RESEARCH THAT ARE IMPACTING I THINK ALL OF US. WHAT ABOUT THE USE OF IMAGING AND LABORATORY FACILITIES THAT REQUIRED PATIENTS TO COME TO ACADEMIC MEDICAL CENTERS AND TO COLLECT DATA THAT MIGHT OR MIGHT NOT BE OF GREAT IMPORTANCE FOR THE TRIALS THAT WE CONDUCT. WHAT ABOUT THE NEED TO COLLECT LOW-GRADE ADVERSE EFFORTS DESPITE THE LACK OF THE RELEVANCE OF THOSE POTENTIAL STUDY END POINTS AND IMPORTANTLY ABOUT WHAT THE LIMITED ACCESS TO PERSONNEL AND FACILITIES AND THE REPROGRAMMING OF CLINICAL RESEARCH RESOURCES FOR CARE THAT ALL OCCURRED VERY RAPIDLY IN FEBRUARY AND MARCH AND APRIL OF 2020. SO WE'VE ALL DEALT WITH THAT AND WE'LL TALK ABOUT HOW SOME OF THE THINGS THAT WE'VE DONE TO TRY TO DEAL WITH THOSE ISSUES. I WANT TODAY EMPHASIZE THAT THERE ARE REALLY ARE MAJOR ON GOING ISSUES THAT EVEN THOUGH SOME OF THE WORST ASPECTS OF THE PANDEMIC HAVE BEEN CONFRONTED AND DEALT WITH, THEY REMAIN CRITICAL SHORTAGES OF RESEARCH NURSES AND CRAs AND RESEARCH STAFF IN REGULATORY OFFICE THAT'S ARE ESSENTIAL. ESSENTIAL HEALTHCARE WORKERS IN RADIOLOGY AND PATHOLOGY AND THE INFRASTRUCTURE AND IN TERMS OF OUR IRBs AND CONTRACTING OFFICES AND REALLY HAVE AUTOMATIC -- THESE HAVE LED TO DELAYS IN REPORTING SO TRIALS MAKE IT OPENED BUT THE DATA ARE NOT GETTING REPORTED IN A TIMELY FASHION IN IS SOME CASES WHICH LEADS TO A DECREASE IN THE TIMELINESS THAT RESULTS GET PUBLISHED. ALL CREDIT GOES TO MY COLLEAGUES WHO THREE YEARS AGO, WORKED VERY QUICKLY FOR THE NCI CLINICAL TRIALS PORTFOLIOS TO CHANGE TO THE USE OF THE ELECTRONIC CONSENTING AND TO PROVIDE ORAL INVESTIGATIONAL AGENCY TO PATIENTS AND TO INITIATE ELECTRONIC RATHER THAN IN-PERSON STUDY AUDITS. TO FACILITATE TELEMEDICINE FOR STUDY VISITS AND THEN TO TAKE SPECIFIC ACTION TO LIMIT THE ADVERSE IMPACT OF MINOR STUDY DEVIATIONS ON TRIAL CONDUCT OR THE EVALUATION OF THOSE TRIALS AND DEGREE CENTRALIZED TESTING AND ENERGY STUDIES AND AS I'LL TALK ABOUT A LITTLE BIT, DURING THAT THE MIDST OF THIS OR THE WORST PART OF THE PANDE PANDEMIN 2020 AND 2021 WE HAD A NEW PLAN FOR NCI CLINICAL TRIALS PROGRAMS WHICH IS IN THE MIDST OF BEING IMPLEMENTED. HERE IS SOME DATA. AND THIS IS UP-TO-DATE DATA THROUGH THE END OF 2022 AND EVERYBODY KNOWS BECAUSE I THINK I'VE SHOWN THIS GROUP BEFORE, WHAT I CALL THE GRAND CANYON IN ACCRUAL, THESE REPE DOES NOT INE THE INDUSTRIAL TRIALS AND IN MARCH AND APRIL AND MAY JUNE THERE WAS THIS 50% DECREASE IN ACCRUAL TO NCTN. CO-OPERATIVE GROUP TRIALS TO INVESTIGATOR INITIALED TRIALS TO PEER-REVIEWED GRANT FUNDED TRIALS AND THE WHAT YOU CAN SEE IN GRAY IS RAPIDLY AND HAPPILY FOR US, THE NCTN ACCRUAL CAME BACK TO WHERE IT WAS IN 2019. AND HAS MAINTAINED A STEADY STATE OVER THE LAST THREE YEARS BUT WHAT I THINK IS EQUALLY CLEAR IN ORANGE FOR PROSECUTE REVIEW TRIALS OR IN BLUE FOR INVESTIGATOR INITIATED TIMES, THE CANCER CENTERS THAT REPORT THIS INTO THE CTRP IT'S STILL ABOUT 25% BELOW WHERE IT WAS BEFORE THE PANDEMIC. AND THIS IS I THINK A MAJOR CONCERN BECAUSE MANY OF THE INNOVATIVE STUDIES THAT INVESTIGATORS PURSUE WHETHER THEY'RE GRANT SUPPORTED IITs HAVE NOT COME BACK AND OVER THE LONG-TERM, AND THREE YEARS IS LONG-TERM, TO HAVE AN ADVERSE I AM IMPACT ON THE A LOT OF OUR CLINICAL TRIALS SYSTEM TO DO WHAT IT NEEDS TO DO. IF YOU LOOK AT THE BARON THE LEFT, YOU SEE WHERE WE WERE IN 2019 AND IN 2020 EVERY CATEGORY OF TRIAL WHETHER IT'S PHARMA, PEER-REVIEWED STUDY AND INSTITUTIONAL TRIAL OR THE NCTN TRIALS HAVE ALL DIMINISHED AND THEY'VE DIMINISHED SIGNIFICANTLY BUT IF YOU COMPARE 2020 TO 2022 AND YOU LOOK AT THE NUMBERS, WHAT YOU SEE IS THE PHARMA ACCRUAL IS BACK TO WHERE IT WAS PRE-PANDEMIC AND NONE OF THE OTHER CATEGORIES SAFE FOR NCTN SO SPECIFICALLY PEER REVIEW TRIALS, GRANT FUNDED TRIALS AND IMPORTANTLY INSTITUTIONAL IITs ARE FAR PEL OWE WHERE THEY WERE PRE-PANDEMIC AND IF YOU LOOK AT THE LIGHT BLUE, WE'RE TALKING ABOUT A DROP FROM 19,000 PATIENTS IN 2019 TO 14,000 PATIENTS ON IITs IN 2022 AND I'M SURE THE MEMBERS OF THE BSA WHO WORK IN CLINICAL TRIALS AT THEIR CANCER CENTERS ARE WELL AWARE OF THIS ISSUE. WE WANTED TO FIND OUT EXACTLY WHAT WAS IND LYING THIS AND I'M SURE NONE OF THE DATA THAT I'M GOING TO SHOW SUE GOING TO BE NEW TO MOST OF YOU. BUT WE DID A SURVEY THAT REMARKABLY GOT A RESPONSE FROM 100% OF THE CANCER CENTERS THAT DO CLINICAL TRIALS. I WANTED TO UNDERSTAND THE IMPACT OF COVID ON THE CURRENT CLINICAL TRIAL CAPACITY AND I THINK THE POINTS TO BE RAISED ARE SHOWN IN BLUE. REALLY, THE MAJOR IMPACT THAT WAS FELT WAS THAT TRIALS WERE NOT OPEN AS RAPIDLY AS ONE HAD HOPED AND THERE WAS BECAUSE OF THE LIMITED CAPACITY OF THE RESEARCH STAFF, THE ACCRUAL TRIALS WERE PUT ON HOLD IN TERMS OF ACCRUAL AND THE ACCRUAL NUMBERS DECREASED AS I SHOWED. SO WHY? WELL, BECAUSE WE LOST A TREMENDOUS PERCENTAGE OF OUR CLINICAL RESEARCH STAFF. AND WHERE DID THEY GO? THEY WENT BASICALLY TO CROs AND PHARMA BECAUSE THOSE ENTITIES WERE ABLE TO PAY SUBSTANTIALLY HIGHER AMOUNTS OF SALARY MONEY AND PROVIDED GREATER FLEXIBILITY AT LEAST INITIALLY IN TERMS OF THE ABILITY TO WORK REMOTELY. AND THIS IS HAD A MAJOR IMPACT, NEXT SLIDE. AND YOU CAN SEE THAT THIS, WE'RE TALKING ABOUT HALF OF OUR LOSS WAS TO PHARMA AND CROs AND THIS ADVERSE IMPACT IS SUCH THAT THE VAST MAJORITY OF THE NCI DES EGG NATURED CANCER CENTERS IN ONE WAY OR ANOTHER HAVE HAD A DIFFICULT TIME IN MAINTAINING THEIR CLINICAL TRIALS ACCRUAL OVER THE LAST THREE YEARS. NEXT SLIDE. WHEN PEOPLE PROVIDE INPUT IN TERMS OF THE LOSSES THEY EXPERIENCE AND THE LOSSES BOTH IN THE REALM OF SENIORS STAFF AS WELL AS RECENT TRAINEES, WHICH MEANS THAT THE ENTIRE POOL OF QUALIFIED CA CANDIDATES WERE SUD UP INTO A DIFFERENT SYSTEM TO DO CLINICAL TRIALS AND THIS HAS HAD AN ADVERSE IMPACT IN THE ABILITY OF MANY CANCER CENTERS TO MAINTAIN THE PACE AND THE VIABILITY OFFER A PROLONGED PERIOD OF TIME. SO, RIGHT IN THE MIDST OF THIS, WE BEGAN WORKING ON A NEW VISION FOR OUR CLINICAL TRIALS PROGRAMS. I'D LIKE TO SHARE SOME OF THE MAJOR AREAS THAT WERE RECOMMENDED FOR CHANGE AND SOME OF THE THINGS THAT WE'VE I AM IMPLEMENTED.THIS IS APP ON GOIN, NEXT SLIDE. WHAT WERE THE MAJOR THEMES. WHAT INFRASTRUCTURES WERE CRITICAL? AND THE MAJOR THEMES WERE TRIAL COMPLEXITY AND COST, NO SURPRISE, HOW DO WE DEAL WITH DECENTRALIZED TRIAL ACTIVITIES WHILE AT THE SAME TIME PROMOTING ACCRUAL AND ACCESS. CAN WE DEVELOP NEW DATA COLLECTION APPROACHES AND HOW DO WE COLLECT PRO DATA IN THIS ENVIRONMENT? AND SPECIFICSLY, HOW DO WE DEAL WITH THE OPERATIONAL BURDEN SO THERE WERE SOME STATISTIC ISSUES AND AT END OF THE THIS ISSUE OF WORKFORCE THAT IS CRITICALLY IMPORTANT. NEXT SLIDE. IF WE TAKE THE 30,000-FOOT VIEW OF THIS ENTIRE PROCESS, OUR GOAL AND THIS IS A MULTI AND ALREADY AND TRY TO DEVELOP MORE FLEXIBILITY, FASTER, SIMPLER, LESS EXPENSIVE TRIALS THAT INTEGRATE WITH CLINICAL PRACTICES AND WE MUST STREAMLINE FOR TRIAL DESIGN AND EXECUTION AND FOCUS ON -- I'LL TALK ABOUT THIS MORE, ON THE MOST ESSENTIAL END POINTS. DECREASE REGULATORY BURDENS AND INCREASE THE EFFICIENCY OF OUR DATA COLLECTION. SO I'M GOING TO TALK A LITTLE BIT ABOUT STREAMLINING CLINICAL TRIALS BECAUSE WE'VE REALLY MADE SOME PROGRESS IN THIS AREA AND I THINK IT'S GOING TO HAVE A SIGNIFICANT IMPACT IN EVERYTHING THAT WE DO IN TERMS OF THE NCI SUPPORT CLINICAL TRIALS AND THE FIRST AREA I'M GOING TO TALK ABOUT IS LIMITING THE DATA ELEMENTS THAT WE COLLECT. YOU ALL KNOW THAT FOR EVERY PIECE OF DATA YOU COLLECT, EVERY DATA ELEMENT COST MONEY. AND WE HAVE TO -- THE QUESTION IS, DO WE NEED TO COLLECT EVERYTHING THAT WE'RE CURRENTLY COLLECTING, ESPECIALLY IN OUR LATE PHASE PORTFOLIO OF TRIALS. AND SO TO ANALYZE WHAT WE'RE DOING, WE PUT TOGETHER AN EXPERT WORKING GROUP AND ANALYZED A LARGE SERIES OF ON GOING PHASE 3 TREATMENT PROTOCOLS TO UNDERSTAND WHAT WE WERE COLLECTING AND JUST HOW IMPORTANT WERE THE DATA THAT -- AND NOW DID IT IMPACT THE OUT PUTS FOR THESE TRIALS. AND I'M ALSO GOING TO TALK ABOUT THE REALLY DIFFICULT ISSUES OF GETTING THE TREATMENT REGIMENTS INTO OUR EHRs A PROBLEM THAT DIDN'T EXIST 10 YEARS AGO THAT THAT'S MADE A MAJOR IMPACT IS COSTLY AND IT'S SOMETHING THAT'S NOT GOTTEN A LOT OF REVIEW AND I THINK I'M GOING TO HELP TO SHOW YOU THAT WE'RE TRYING TO MAKE SOME IMPACT IN DEALING WITH THIS REALLY IMPORTANT PROBLEM AND IT SLOWS DOWN THE ENTIRE PROCESS AND IT'S VERY COSTLY. NEXT SLIDE. SO WHAT ARE THE LOW DATA VALUE ELEMENTS THAT ARE EXPERT GROUP CAME UP WITH. WHAT IS THE SCOPE OF THE RECOMMENDATION THAT'S THEY CAME UP WITH SO THE FIRST WE GET IS TO TRY TO UNDERSTAND WHERE COULD WE FOCUS ON CHANGING THE STANDARD OF PRACTICE. WHAT DID WE HAVE CONTROL OVER THAT COULD BE RESULTED IN CHANGES THAT WE COULD MANAGE IN A RELATIVELY RAPID TIMEFRAME. SO WE FOCUSED INITIALLY ON EVALUATING CTEP MANAGED TRIALS, LATE-PHASE TRIALS, TREATMENT TRIALS AND ADULT TRIALS AND IND EXEMPT TRIALS. IT DOESN'T MEAN THAT WE'RE NOT INTERESTED IN PEDIATRIC TRIALS OR PREVENTION TRIALS OR OTHER KINDS OF THINGS BUT THESE THINGS BECAUSE THEY'RE IND EXEMPT, AND HAVE OUR MAKE UP A MAJOR PORTION OF THE PORTFOLIO OF NCTN TRIALS, WE COULD CHANGE WITHOUT GETTING MAKING MAJOR REGULATORY HAVING REGULATORY HURDLES. NEXT SLIDE. SO WHAT ARE THE CATEGORIES THAT WE'RE EVALUATING? THESE ARE THE THINGS IF YOU REALLY TALK TO FOLKS WHO ARE IN THE DAY-TO-DAY BUSINESS OF RUNNING CLINICAL TRIALS, EVERY ONE OF THESE CATEGORIES, WE COULD SPEND HOURS ON THE COMPLAINTS THAT PEOPLE HAVE ABOUT THE EXCESS AMOUNT OF DATA THAT WE COLLECT IN EVERY ONE OF THESE AREAS AND I'M GOING TO SHOW YOU SOME OF THE THINGS WE THINK CAN BE CHANGED THAT WILL STREAMLINE THE PROCESS OF OUR LATE PHASE CLINICAL TRIALS PROGRAMS. NEXT SLIDE. I WOULD SAY ON THE TOP OF THE LIST OF PET PEEVES THAT CLINICAL INVESTIGATORS HAVE IS WHY WE SHOULD CONTINUE TO COLLECT FOR WELL ESTABLISHED DRUGS THAT HAVE TOXICITY PROFILES THAT ARE WELL-KNOWN, WHY SHOULD WE COLLECT LOW-GRADE ADVERSE EVENTS AND PROBABLY WORSE, WHY SHOULD WE TRY TO UNDERSTAND THE ATTRIBUTION, AND WORSE OF ALL, THEIR START DATE AND STOP DATES. WE HAVE CRAs SPENDING HOURS AND SHOWERS TRYING TO ASSESS FROM THE MEDICAL RECORD THOSE DATA ARE ESSENTIALLY NEVER USED WHEN THE PUBLICATION COMES OUT. WE THOUGHT FOUGHT CLEARLY ABOUT ALL THE EXCESS LABORATORY DATA THAT'S COLLECTED AND ESPECIALLY LABORATORY THAT'S COLLECTED BEYOND STANDARD OF CARE AND IT'S UNRELATE TO STUDY ENTER POINTS OR SAFETY MONITORING. I'VE HAD PERSONAL EXPERIENCE WHEN I WAS ON ODAC OF PEOPLE WANTING TO KNOW WHAT MIGHT THE HEMOGLOBIN BE ON DATE 8 OF CYCLE 14 OF SOME REGIMENT THAT HAD NOTHING TO DO WITH THE OUTCOME OF THE TRIAL. WE COLLECT ALL THAT DATA. WE DON'T USE THAT DATA. AND THIS MEANS THAT THERE ARE UP USED COMPONENTS IN LABORATORY PANELS THAT GET PUT INTO CASE REPORT FORMS AND THAT ARE ABSOLUTELY UNNECESSARY AND TAKE TIME AND NEVER HAVE SIGNIFICANT IMPACT ON THE OVER ALL OUTCOME OF THE TRIAL AND THE SAME CAN BE SAID CHAPTER AND VERSE FOR IMAGING THAT IS DONE BEYOND THE STANDARD OF CARE. NEXT SLIDE. REMARKABLY, THERE ARE MANY THINGS ABOUT HISTORY AND PHYSICAL EXAMINATION. THEY'RE NEVER USED. WE COLLECT ENORMOUS AMOUNTS OF DATA ON MEDICATION THAT'S ARE COMPLETELY IRRELEVANT TO PROTOCOLS. WE COLLECT EVEN MORE DATA WHEN THOSE CON COM TANT ARE STARTED AND DIS CONTINUED THAT HAVE NORTH TO DO WITH SAFETY. THEY WILL BE FOCUSED ON LATE-STAGE TRIALS, IND EXEMPT TRIALS TO REDUCE THE OPERATIONAL BURDEN OF THOSE TRIALS AND THEN TO PROVIDE INSIGHTS THAT WILL INFORM US IN TERMS OF WHAT IS ACTUALLY NEEDED, WHAT DATA ARE NEEDED TO BE COLLECTED, FOR A LATE-PHASE IND RELATED TRIALS AND PEDIATRIC TRIALS AND WE ARE IN THE PROCESS OF TRYING TO DEVELOP A BROAD STAKEHOLDER ENGAGEMENT IN INPUT AND HOW TO SUCCESSFULLY IMPLEMENT CHANGES THAT WILL BE EMBRACED ACROSS THE COMMUNITY AND REQUIRING US TO COLLECT MUCH LESS DATA AND HOPEFULLY WILL ALLOW US TO USE OUR PERSONAL MUCH MORE EFFECTIVELY. NEXT SLIDE. THIS IS NOT JUST A FANTASY. THIS IS THE SCHEME FOR THE PRAGMATIC TRIAL. I WANT TO SAY TWO THINGS ABOUT THIS STUDY. WE STARTED TALKING ABOUT THIS TRIAL LATE IN AUGUST. OF 2022. THE FIRST PATIENT WAS ENTERED ON PRAG PRAGMATIC LAST WEEK. SIX AND A HALF MONTHS FROM START TO FINISH FOR A RANDOMIZED TRIAL THAT WILL LEAD TO AN INDICATION PROVED BY THE FDA AND A SURVIVAL OUTCOME ONLY, NO PFS, WITH MINIMAL IMAGING AND MINIMAL LABORATORY COLLECTION, AND NO ADVERSE EVENTS COLLECTED EXCEPT FOR HOSPITALIZATIONS THAT HAS A SCHEME A PAGE THAT IS SMALLER THAN ANYONE WHO HAS WRITTEN A CLIP CAL CLINICAL TRIALS BECAUSS DATA BECAUSE WE'RE LOOKING FOR WHETHER OR NOT THIS TRIAL, WHICH IS AN EXPANSION OF A TRIAL THAT WAS INITIALLY A SMALL RANDOMIZED PHASE 2 STUDY IN LONG MAP, NOW EXPANDED TO ABOUT 700 PATIENTS WILL ACTUALLY REACH THE MOST IMPORTANT END POINT THAT IS THERE A COMBINATION OF A INHIBITOR AND A CHECKPOINT INHIBITOR WILL CHANGE THE SURVIVAL IN THIRD LINE NON SMALL LUNG CANCER TREATMENT. THAT'S IT. THAT'S THE QUESTION. EITHER WILL OR IT WON'T. IF IT DOES, IT'S LIKELY TO GET APPROVED SPECIFICALLY BY THE FDA AND WITH THE FULL CONCEPT OF AMERICAMERCKAND LILLY. IT'S POSSIBLE TO WRITE TRIALS THAT REQUIRE MINIMAL DATA THAT COULD ACTUALLY LEAD TO AN IMPORTANT CHANGE IN THE STANDARD OF CARE. SO I'D LIKE TO SAY A WORD TO EHR BILLS SO THIS IS NOT SOMETHING THAT GETS A LOT OF PUBLICITY AND YET IT IS THE BAIN OF THE EXISTENCE OF EVERY CLINICAL TRIALS OFFICE IN EVERY NCI DESIGNATED CANCER CENTER. SO WHAT DOES THIS MEAN? IT MEANS THAT FOR THOSE WHO REPEAT FAMILIAR WITH THIS, EVERY TIME YOU HAVE A CLINICAL TRIAL, IT REQUIRES THAT THE ORDERS FOR THE THE TREATMENT AND ALL THE LABORATORY STUDIES THAT WILL BE PERFORMED IN ALL THE STUDY VISITS GET PROGRAMMED INTO THE EHR RECORD SO WHY IS THAT A PROBLEM? WELL THE PROBLEM IS EVERY HOSPITAL THAT'S A DIFFERENT DRUG FORMULARY AND EVERY HOST AND CANCER CENTER HAS VARIETIES THAT MAY BE MODEST AND THEY'RE STILL DIFFERENT IN TERMS OF THE CLINICAL PRACTICE GUIDELINES THAT ARE USED FOR HOW DRUGS ARE PUT INTO VARIOUS KINDS OF INTERVENE US SOLUTIONS SO, IT MAY BE THAT AT THE DANA FARBER IS ONLY GIVEN IN SALINE AND IF THE CITY OF HOPE IT MAY BE GIVEN IN HALF NORMAL SALINE AND SOME PLACE ELSE IT MAY BE 50CCs AND SOME PLACE IT'S A LITER. EVERY SINGLE TIME THAT DRUG IS USED IN ANY PROTOCOL IT HAS TO BE DONE IN SUCH A WAY THAT IS CONSISTENT WITH THE INDIVIDUAL PRACTICE IN THAT HOSPITAL. SO THE ENORMOUS VARIATION ACROSS PROTOCOLS, AND IN TERMS OF WHAT IS IN THE PROTOCOL, AND WHAT IS NOT IN THE PROTOCOL AND HOW THAT GETS PUT INTO THE INDIVIDUAL INSTITUTIONS EHR IS ENORMOUS AND IT IS BEEN ESTIMATED THAT IT TAKES OVER 24 HOURS TO BUILD A TREATMENT PLANT FOR A SINGLE STUDY ARM IN EPIC SO LET ME JUST DO THE MATH, FOR NCI MATCH, 39 ARMS, ACROSS OVER 1800 SITES TIMES 26 HOURS AND IT'S UNBELIEVABLE AND THIS AMOUNT OF WORK AND LITERALLY BILLIONS OF DOLLARS TO BE ABLE TO PUT THE INFORMATION THAT YOU NEED TO CARRY OUT IN THE ELECTRONIC HEALTH RECORD AND THE LOGO RESOURCES ARE NEVER FULLY REIMBURSE AND SO THIS IS A HUGE PROBLEM AND WE'RE HOPING TO DO AT LEAST MAKE SOME DENT IN. SO, OUR GOAL IS TO TRY TO FACILITATE STANDARDIZED AND ACROSS CLINICAL TRIALS AND ABOUT A YEAR AND A HALF AND WE FUNDED TWO CONSORTIA AND CENTER TO CENTER TO CENTER. WE ARE IN THE PROCESS. PACKAGE THESE IN FORMS THAT CAN BE IMPORTED DIRECTLY INTO A SITE CHR OR WILL FACILITATE LOGO CUSTOMIZATION AND TO BASICALLY ECONOMIZE THIS EFFORT BECAUSE NOTHING COULD BE BETTER AND IF WE CAN HARM ON EYES THOSE THINGS IT WOULD SAVE MONTHS OF TIME TO ACTIVATE PROTOCOLS SITE AFTER SITE IT WOULD BE A WONDERFUL IF WE CAN FORMALIZE AND A LOT EASIER AND OPERATIONALIZE THEIR ACTIVATION OF THEIR TRIALS AND SAVE ENORMOUS AMOUNT OF MONEY. NEXT SLIDE. THE LAST THING I WOULD LIKE TO COME BACK TO, I SAID I WANTED TO ADDRESS SOME OF THESE ISSUES RELATED TO WORKFORCE. BECAUSE THIS IS A BIG DEAL. FROM CENTER TO CENTER AND SOME PLACES HAVE DEALT WITH IT BETTER THAN OTHERS AND THERE ARE SITES THAT LITERALLY OVER THE LAST THREE YEARS HAVE LOST 60% OF THEIR ENTIRE CLINICAL TRIALS WORKFORCE AND THEY'VE HAD TO REPLACE THOSE INDIVIDUALS THE NCI CAN HELP STREAMLINE THE PROCESS FOR TRIAL ACTIVATION AND MOST IMPORTANTLY REDUCE THE VOLUME OF WORK THAT'S REQUIRED TRIAL BY TRIAL AND TRY TO INCREASE THE FLEXIBILITY OF DOING THESE THINGS TO MAKE IT EASIER FOR CENTERS TO OPEN OUR TRIALS. SOME OF THE THINGS THAT I'VE TALKED ABOUT BEFORE THAT WIRE WORKING ON. IT'S WHETHER WE CAN CONSIDER DEVELOPING A TRAINING PROGRAM, TO TRY TO FOCUS THE DEVELOPMENT AND FACILITATE THE HIRING AND TRAINING OF INDIVIDUALS WHO MANY ARE IN POSTBAC PROGRAMS THAT WANT TO USE TRAINING AS A CRA, AS A STEPPING STONE OR WANT THIS AS A LONG-TERM CAREER AND WE FACILITATE DEVELOPING THOSE PROGRAMS AT CANCER CENTERS TO FIND THE PUMP SO WE HAVE A LONGER TERM SOLUTION TO FINDING THE PERSONNEL IT REQUIRES. LASTLY, I HOPE TO HAVE IF ABOUT SIX MONTHS HAVE ENOUGH EXPERIENCE IN THIS WHAT I CALL A VIRTUAL CLINICAL TRIALS OFFICE PILOT STUDY WE STARTED IN THE LAST FEW MONTHS AND TO TRY TO BRING BACK TO YOU, INTO THE METADATA RAVE SYSTEM TO TAKE THIS BURDEN OFF SITE SO THEY CAN ACTUALLY ACCRUE THEIR STUDIES AND OPEN THEIR TRIALS AND DO IT IN A MORE TIME EFFICIENT MANNER AND REALLY CONTINUE THE PROCESS OF OUR TRANSLATIONAL STUDIES IN A MORE EFFICIENT WAY. I'M HAPPY TO STOP HERE AND TAKE AS MANY QUESTIONS AS WE HAVE TIME FOR. >> THANK YOU, ANYMORE. IT'S QUITE AN INSPIRED INITIATIVE. I WILL JUST SAY AS A COMMENT, I'LL SAVE QUESTIONS FOR MABEL OFF LINE COMMUNICATIONS BUT REALLY FABULOUS. I THINK RAY, YOU MIGHT HAVE BEEN FIRST. >> YEAH, THANK YOU, KEITH. SO, JIM, I HAVE TO CONGRATULATE YOU FOR KEEPING THE FING FINGERF THE PULSE. I'M BLOWN AWAY HOW COMPREHENSIVE AND HO DEEP YOUR KNOWLEDGE FROM THE STANDARD EVIDENCE WHAT LIFE IS LIKE ON THE STREETS AND THE MINORITY UNDER SURVEY IN A HUGE COMMUNITY HEALTH-CARE SYSTEM ACROSS THE MISSISSIPPI DELTA AND THAT HAD NO PRIOR RESEARCH ACTIVITY AND YOU KNOW, A LOT OF WHAT YOU HAVE RAISED ARE VERY GERMANE AND SO A FEW THINGS I JUST WANT TO REINFORCE, ONE IS THIS COMPLEXITY OF INANE REQUEST THAT JUST CLEARLY ARE NOT RELEVANT TO THE WORK AT HAND THAT TAKE ON A LIFE OF THEIR OWN AND OCCUPY A LOT OF HUMAN RESOURCE AND I THINK IT'S VERY MUCH WORTHY OF IT'S LOOKING CRITICALLY UNLESS IT'S REALLY REDUNDANT THE THINGS THAT WE DO AND QUESTION I DO HAVE, JIM, IS THE END CORE RELAXATION ITEMS THAT CAME OUT OF THE VANCOUVER PANDEMIC, WE KEEP ASKING, WILL THEY BE MADE PERMANENT. WE DON'T WANT TO GO BACK TO A WORLD IN WHICH THINGS THAT TECHNOLOGY WILL ENABLE US TO DO MORE EFFICIENTLY AND WE HAVE TO DO MANUALLY SO DO YOU HAVE DO YOU HAVE A WORD OF THAT? >> WE'RE NOT GOING TO STOP SENDING ORAL DRUGS OUT TO SITES. PEOPLE ARE NOT GOING TO HAVE TO DRIVE 100 MILES ON PILLS AND WE'RE NOT GOING TO GO BACK TO WE REALLY -- I HOPE THAT THE RELAXATION IN TERMS OF BEING DINGED FOR GRADE 1 APPROXIMATE AEs THAT ARE USE LESS IN YOUR AUDITS IT MUST STOP, RIGHT. IT'S GOT TO BE THE COMMUNITY HAS TO AGREE THAT WE'RE GOING TO STOP THAT AND THE OUTCOME OF OUR TRIALS WILL BE JUST FINE WITHOUT THAT. I'VE BEEN ASKED ABOUT IMPORTANT ISSUES THAT I THINK YOU WOULD AGREE WITH. THERE ARE SOME THINGS THAT ARE LOW GRADE BUT CHRONIC TALKS SIS TEE. ESPECIALLY IF THEY'RE NOT KNOWN. WE CAN'T GIVE UP. SO IF SOMEONE HAS GRADE 2 DIARRHEA FOR FOUR MONTHS, YOU PROBABLY WANT TO KNOW THAT, RIGHT. YOU DON'T WANT TO KNOW IF SOMEONE HAS A HEMOGLOBIN OF 9.9 ON CYCLE FOUR OF WHATEVER. THAT'S USE LESS INFORMATION THAT'S NEVER GOING TO HAVE AN IMPACT ON YOUR PRACTICE, RIGHT. AND THE REAL WORLD. SO, MY VIEW IS THAT WE HAVE TO MAKE -- AND THIS SOUNDS SO BUREAUCRATIC YOU WILL JUST LAUGH, RIGHT. IT TURNS OUT, THAT WHAT IS THE ISSUE WITH TELEHEALTH. WE NEED TO LEARN HOW TO DO TELEHEALTH, TELEMEDICINE IN OUR TRIALS BETTER, OKAY. BUT IN TERMS OF IT BEING SOMETHING THAT IS ACCEPTABLE, IT NEEDS TO BE TELEHEALTH AND WE WEREN'T WRITING THOSE INTO PROTOCOLS. THIS IS BASICALLY ADMINISTRATIVE GOOK THAT CAN BE CHANGED VERY EASILY, RIGHT, AND SO TO ME THE NEXT STEP IS WE DID ALL THESE THINGS, WHAT IS THE NEXT WHOLE RANGE OF THINGS THAT WE DON'T HAVE TO DO? NOW I'M NOT -- YOU KNOW, I'M A PHASE 1 INVESTIGATOR, WE DON'T NEED TO VERY CAREFULLY, VERY CAREFULLY COLLECT INFORMATION ON TOXICITY AND EARLY PHASE TRIALS AND I DON'T MEAN TO IMPLY THAT AT ALL BUT HOW MANY TIMES DO WE HAVE TO RECOLLECT DATA ON PATIENTS GETTING A PEM BROW, RIGHT. WE DON'T. THIS MAKES A DIFFERENCE BECAUSE I REALLY, IF YOU THINK ABOUT WHAT CROs DO, AND THEY WANT TO COLLECT THIS AND I DON'T MEAN T. THEY GET PAID FOR EVERY DATA ELEMENT SO THE MORE THINGS THAT WE COLLECT, THE MORE THEY GET PAID. SO I THINK WE WILL RUN INTO THE LESS WE DO AND IF WE CAN HAVE OUTCOMES THAT SHOW WE GET THE ANSWERS TO THE QUESTIONS WE'RE INTERESTED IN, THEN WE'LL BE PUSH BACK FROM PHARMA. RIGHT. BUT THAT'S THE BLESSING OF HAVING THE NCI CLINICAL TRIALS PROGRAM, ESPECIALLY TO DO IF WE FOCUS INITIALLY ON NON IND STUDIES IS WE CAN MAKE THESE CHANGES. AND SEE WHAT THE OUTCOMES ARE GOING TO BE. >> WE'RE GOING TO BE PRESSED FOR TIME. OTIS -- >> FIRST, I JUST WANT TO SAY THANK YOU JIM. YOU JUST DON'T KNOW HOW THRILLED I AM TO KNOW THAT SOMEONE FROM THE GOVERNMENT UNDERSTANDS ME AND MY PROBLEMS. THE ONE THING THAT I WOULD ADD, DID THE CHARACTER IN NATURE OF OUR CLINICAL TRIALS CHANGE OVER THE LAST 10 YEARS AS WE WEPT TO PRECISION, MEDICINE AND IMMUNO THERAPIES AND OTHER THINGS AND DID THAT CONTRIBUTE TO THE DECLINE IN ENROLLMENT AS WELL? AT OUR INSTITUTION, ENROLLMENT STARTED DECLINING AND COVID JUST ACCELERATED THINGS EVEN FURTHER AND I'M WONDERING IF THAT'S PART OF THE REASON FOR THE DECLINE IT'S LIKE DECK CRATING CHRISTMAS TREES AND THEY'RE PRETTY BUT THEY DON'T REALLY CONTRIBUTE TO THE QUESTIONS THAT WE WANT TO ANSWER. AND THAT'S WHAT WE HAVE TO THINK ABOUT SERIOUSLY. >> THANK YOU SO MUCH. I MEAN, THIS IS LIKE THE SOLUTION FOR THE FUTURE FOR WORKFORCE ACROSS THE COUNTRY AND WITH NEW FORMS OF AI, WE MAY HAVE EVEN MORE POTENTIAL THERE. I WANTED TO ASK YOU, I HEARD CHALLENGES AND BIG PLAYERS IN SOFTWARE FIELD WHETHER IT'S EPIC OR ENCORE BEING COMPATIBLE SHALL WE SAY. WHAT CAN WE DO TO MOVE FORWARD OR WHAT'S YOUR APPROACH TO THIS? ARE YOU PLANNING TO START WITH SOME PLAYERS FIRST AND SEE WHAT WE CAN DO? >> SO THAT CONSORTIUM WORKING THERE'S ABOUT 10 NCI CANCER CENTERS WORKING ON THESE THINGS AND EPIC IS INVOLVED WHEN SENATORS INVOLVED MORE SO EPIC. BUT I THINK THE PROBLEM IS -- I HAD NO IDEA BECAUSE YOU KNOW, WE HAVE A COMPLETELY HOMEGROWN CLINICAL TRIALS MAPPINGMENT MANT SYSTEM AND IT'S UNLIKE ANYTHING ELSE OUT THERE AND I HAD NO IDEA THAT TO PUT 80 POTENTIAL DATA ELEMENTS TO ENTER ONE ORDER OF SIS PLATINUM, 80 DIFFERENT FIELDS THAT MIGHT CONCEIVABLY -- SO WE JUST HAVE TO FIGURE OUT A WAY AND ACTUALLY THE QUESTION CAME UP EARLIER AND I LIKE TO ADDRESS THAT AND YOU KNOW, IF WE WROTE PROTOCOLS WE DIDN'T WRITE THEM IN ENGLISH. WE WROTE THEM IN A FORMAT THAT BASICALLY JUST WROTE SCHEME A PAGES AND THEY COULD BE DIGITIZED IT WOULD MAKE THE ENTIRE PROCESS MUCH, MUCH SIMPLER. BUT I MEAN, YOU KNOW, IT'S JUST NOT WHAT PEOPLE HAVE DONE FOR 60 YEARS. THAT'S WHAT NEEDS TO BE DONE BECAUSE THEN YOU WOULD START FROM A -- EVERYONE WOULD START WITH A TEMPLATE THEY COULD MUCH MORE RAPIDLY ADAPT TO THEIR. >> PAULETTE IS STARING AT ME IN THE SCREEN AND BOB. >> THE IMPLEMENTATION AND ONE THING IS COMMENT AND THE CHAINING FOR THE WORKFORCE AND AND I WOULD JUST ADD ONE AND THINK ABOUT IN THAT AND RESEARCH BASIS AND IN THE COMMUNITY ALTHOUGH THERE'S A SIGNIFICANT OVERLAP BETWEEN THOSE THAT MAYBE WORK IN A CTO AND THERE'S ALSO A LOT THAT IS REALLY DIFFERENT AND MAKING SURE THAT THOSE ENTITIES COULD ALSO TAKE ADVANTAGE OF ANY KIND OF TRAINING GRADE OR TRAINING OPPORTUNITIES TO CREATE THOSE TO GENERATE THAT WORKFORCE AS WELL AND THEN MY QUESTION TO YOU IS WHEN WE THINK ABOUT SIMPLIFYING AND I COULDN'T AGREE WITH YOU MORE AND FOR US, WITH I THINK ABOUT THE RESEARCH BASE THAT I WORK IN AND HAVING A INVESTIGATOR PUT OUT A STUDY THAT IS AGREED UPON AND BY PIPELINE FOR TREATMENT GRANT AND THEY HAVE TO GO BEFORE A STEERING COMMITTEE FOR A PEER RW AND MANY ARE RO1 THAT IS PEER-REVIEWED SO IF APPROXIMATE YOU WANT THESE COULD BE SIMPLIFIED AND WHAT IS THE PLAN TO EDUCATE ALL THE DIFFERENT BODIES OF PEOPLE WHO ARE REVIEWING THE GRANTS BECAUSE THAT'S WHERE THEY END UP BECOME SEWING SOPHISTICATED THAT THEY'RE IMPOSSIBLE TO DO. SO WRITE IN BLACK WHITE NEW SOPs FOR WHAT IS -- AT LEAST I CAN'T TELL PHARMA WHAT TO DO. BUT WE CAN PUBLISH WHAT THE SOPs ARE FOR NCI TRIALS. WE CAN GET -- IF WE CAN BUY IN FROM THE NCTN GROUPS AND IT WILL CHANGE. IT WILL TAKE TIME. NEW STUDIES CAN BE DEVELOPED SAYING WELL, WE DON'T DO IT THIS WAY ANYMORE. THIS IS WHAT THE ENTIRE SYSTEM AS AGREED TO CHANGE AND IT WILL OVER TIME IT WILL CHANGE. >> YOU COULD WRITE THAT IN AN SOP BUT IF I HAVE AN INVESTIGATOR WHO IS GOING AFTER AFTER RO1 IN A REVIEW PANEL IT'S SAYING, WE KNOW YOU ARE ONLY PUT YOUR MEASURE THESE TWO OUTCOMES BUT WE WANT THESE FIVE COMPOUNDERS ALSO ADDED INTO THAT TRIAL IT'S A PEER REVIEW LONG BEFORE IT GETS TO OVER ALL DEVELOPMENT SO HOW CAN WE TAKE CARE OF THAT? >> MAYBE WE CHALLENGE THE USE OF CLINICAL PROGRESS NOTES FOR DATA COLLECTION AND LET'S JUST TAKE IT ALL ON. I JUST WANTED SAY QUICKLY, AMONG THE STAKEHOLDERS, WE RECOGNIZE WE ARE OWN OUR WORSEN MO ENEMY. WE HAVE NEED DEEPER CONVERSATIONS WITH PHARMA AND CONTRACT RESEARCH ORGANIZATIONS. AND I'VE BEEN PART OF A LOT OF PANELS AND I NEVER SEE A CRO REPRESENTED. I DON'T KNOW WHAT CAN NCI DO TO ENGAGE THE CROs SO THAT WE FIX THIS, NOT JUST NCI TRIALS BUT EVERYTHING? >> MY TWO CENTS IS THAT YOU KNOW, PHARMA RELUCTANT BECAUSE THEY HAVE -- THEY HAVE PERCEPTIONS OF WHAT THE FDA REQUIRES. AND SO AS Dr. BERTAGNOLLI SAID, DOING THINGS THAT ARE DONE IN CONCERT WITH THE FDA WHERE IT IS VERY CLEAR THAT THE REGULATORS SAY YOU DON'T NEED THIS INFORMATION AND IT'S THE ONLY WAY WE'LL REACH PHARMA. YOU HAVE TO KNOW IF THEY DO THOSE THINGS IN A DIFFERENT WAY, IF THEY'RE NOT PENALIZED WHEN THEY GO FOR APPROVAL. >> Dr. Flaherty: THANK YOU FOR REALLY EXCITING PRESENTATION AND IF YOU DON'T MIND CHECKING THE CHAT WINDOW BECAUSE THERE'S A FEW OVERFLOW QUESTIONS AND COMMENTS THAT WE DIDN'T HAVE TIME TO GET TO. LET'S MOVE TO CONCEPTS. WE HAVE THREE NEW AND UNREISSUED CONCEPT FOR TODAY'S DISCUSSION AND BSA MEMBERS HAVE BEEN REVIEWEDDERS AND INTERACTED WITH THE PRESENTSERS IN ADVANCE BUT WE NEED THE ENTIRETY OF THE BSA TO ENGAGE IN TODAY'S DISCUSSION AND ULTIMATELY VOTING FOR NEW CONCEPTS, WE WILL VOTE TO APPROVE DISAPPROVAL OR DEFER AND FOR THE ONE REISSUE CONCEPT, WE VOTE TO CONQ TO CONNECTICUT ACRD JUST TO REMIND YOU WHEN WE'RE IN THE VIRTUAL MODE HERE, KEEP YOUR CAMERAS ON WHEN WE'RE IN DISCUSSIONS AND THE VOTING PHASE AND I WILL COUNT YOUR PRESENCE AS A VOTE YES VO TAKE YOUR PICKD NOTIFYING ME AND WALL OUT AND PLEASE END INDICATE YOU ARE ABSTAINING AND STATE YOUR NAME. THE FIRST IS A NEW RFA AND SO COOPERATIVES AGREEMENT AND TRANSLATIONAL RESEARCH AND AND VACCINE AND IT'S GOING TO PRESENT AND THE SUBCOMMITTEE IS BEING CHAIRED BY DORTHY AND MARK AND BOB ARE MEMBERS OF THE SUBCOMMITTEE AS WELL AND REBECA, PLEASE TAKE IT AWAY. DIVISION OF CANCER CONTROL AND POPULATION STUDIES AND THE DIVISION OF CANCER BIOLOGY AND THE CENTER FOR GLOBAL HEALTH. THE PURPOSE OF THE RFA IS TO SUPPORT BASIC AND TRANSLATIONAL RESEARCH AND IT WILL GUIDE THE DEVELOPMENT OF A PREVENTATIVE OR NEED YOU'D I CAN WITH THE GOAL TO PREVENT AND TREAT KS AND OTHER KSHV AND OTHER ASSOCIATED DISEASES. THERE ARE FOUR KS TYPES EPIDEMIOLOGICALLY AND CLASSIC KS, TYPICALLY EFFECTS ELDERLY MEN OF MEDITERRANEAN DISSENT AND AN DEMIC KS WHICH OCCURS PRIMARILY IN CENTRAL AND SOUTHEAST AFRICA AND IT'S VERY AGGRESSIVE AND IMMUNO SUPPRESSION ASSOCIATED KS OCCURS IF TRANSPLANT PATIENTS AND EPIDEMIC KS OR AIDS RELATED KS JUST WANT OF THE POST COMMON HIV ASSOCIATED TUMORS IN THE U.S. AND THE MOST COMMON IN AFRICA NEXT SLIDE, PLEASE. RSHV IS HUMAN HERPESES VIRUS 8 IT WAS DISCOVERED IN FIRST-DEGREE 9 AND THE CAUSE TIVE AGENT OF KAPOSI SARCOMA AND MULTI CENTRIC CASTLE MEN DISEASE AND SIM LOMA ASSOCIATED WITH MCD AND CYTOKINE. THIS IS KS MOST MUCH OCCURS IN INDIVIDUALS WITH HIV WITH 90% OF THE CASES OCCURRING IF LOW AND MIDDLE INCOME COUNTRY. WITH OVER TWO-THIRDS OF THE CASES OCCURRING IN SUB SA HER ENTER AFRICA WHERE IT'S SIGNIFICANTLY CAUSE OF MORBIDITY AND MORTALITY. IT'S IMPORTANT TO NOTE THAT WITH RESPECT TO THE HIV EPIDEMIC AND KS INCIDENTS, COMBINATION ANTI RETRO VIRAL THERAPY DID INITIALLY DECREASE THE INCIDENTS OF KS IN THE UNITED STATES AND OTHER DEVELOPED COUNTRIES AND HOWEVER, THE DECREASE IN KS THAT IS PLAT AUD AND KS IS STILL ONE OF THE MOST COMMON MALIGNANCY ASSOCIATED WITH HIV. EVEN WHEN HIV IS WELL CONTROLLED. NEXT SLIDE, PLEASE. THIS SLIDE DEMONSTRATES A STUDY AT FOUR SITES IN EAST AFRICA. IT FOLLOWED 180 ADULT S WITH NEWLY DIAGNOSED HIV KS IN KENYA AND UGANDA AND DESPITE BEING ON SEA ART, WITH 46 OF THE PATIENTS AT THIS STAGE PROGNOSIS AND SURVIVAL IS POOR. IN THIS STUDY, 33% OF THE PATIENTS HAD DIED BY SIX MONTHS. NEXT SLIDE, PLEASE. NOW I'D LIKE TO PROVIDE SOME BASIC INFORMATION REGARDING KSA PREVALENCE AND KS AND KSV. CHILDREN ARE INFECTED EARLIER IN LIFE AND IN SOME COUNTRIES HAVE AN 83% PREVALENCE BY AGE 19. IN NORTH AMERICA, AND MOST OF AUTOPSY UP, OVER ALL ZERO PREVALENCE IS LOW BUT HIGHER IN MEN WHO HAVE SEX WITH MEN, MSM AND PERSONS FROM ENDEMIC AREAS IN THE U.S., KHS AND IS 365% IN HIV POSITIVE MSM AND 20% TO 30% IN THE HIV NEGATIVE MSM AND INCIDENTS OF KS IN THE U.K. PEOPLE WITH HIV IS DECREASING WITH COMBINATION ANTI RETRO VIRAL THERAPY HOWEVER, INCIDENTS IS INCREASING IN YOUNG BLACK MEN IN THE SOUTH. IN PARTS OF AFRICA, INCIDENTS OF KS REMAINS HIGH EVEN WIDESPREAD USE OF CR AND MULTI CENTRIC CASTLE MAN DISEASE HAS BEEN FOUND TO REPRESENT ALSO CAL KS IS A DISEASE OF THE ELDERLY AND THE HIV INFECTED POPULATION IS AGING IN THE U.S. THERE ARE CONCERNS THAT WE MAY SEE AN INCREASE IN KS AS BOTH HIV POSITIVE AND HIV NEGATIVE MEN WHO HAVE SEX WITH MEN WITH HSHV INFECTION AGE. KSHV IS OFTEN FOUND IN ORAL FLUIDS AND EVIDENCE TO DATE IND INDICATES THAT THIS IS THE MAIN ROUTE OF SPREAD. HOWEVER, MANY QUESTIONS REMAIN REGARDING PRINCIPLE MODES OF TRANSMISSION. IN AFRICA, ACQUISITION PRIMARILY OCCURS DURING CHILDHOOD. IN NON-ENDEMIC AREAS, SESSI IT S IN MSN. THE ROLE OF HETEROSEXUAL TRANSMISSION REMAINS IN CONCLUSIVE AND A PARSE TO VARY IN DIFFERENT PARTS OF THE WORLD. NEXT SLIDE, PLEASE. THE DOC PARTICIPATING IN THIS CURRENT CONCEPT PROPOSAL DEVELOPED AN RFA INVESTIGATION OF THE TRANSMISSION OF KSHV NINE RO1 GRANTS WERE AWARDED AND THE GOAL OF THE RFA WAS TO ADVANCE OUR KNOWLEDGE OF KSHV TRANSMISSION. AREAS OF RESEARCH ADDRESSED AND FUNDED GRANTS INCLUDES UNDERSTANDING THE STEPS IN KSHV INFECTION AND THE CHARACTERISTIC OF THE INITIAL IMMUNE RESPONSE TO KSHV AND KSHV IN HIGH-RISK GROUPS AND UNDERSTANDING THE BEHAVIORAL ENVIRONMENTAL GENETIC RISK FACTORS FOR KSHV. NEXT SLIDE, PLEASE. THE MSA, THE NCI, BSA SUBCOMMITTEE HAS BEEN DEFINING GAPS IN OUR UNDERSTANDING AND IN INFECTION AND SINCE AT FIRST CONVENED. WITH NCI'S DEVELOPMENT, OF THE KSHV TRANSMISSION RFA, THE BSA AD HOC WORKING GROUCH ENDORSED BY THE BSA. NEXT SLIDE, PLEASE. IN OCTOBER OF 2021, THEY HELD A VIRTUAL STATE OF THE SCIENCE WORKSHOP. EXPERTISE ACROSS THE SPECIFICS TRUONIMMUNOLOGY AND DISCUSSING E BENEFITS AND FEASIBILITY OF DEVELOPING A VACCINE AGAINST KSHV AND THEY DISCUSSED GAPS IN KNOWLEDGE AND REGARDING KSHV TRANSMISSION, EPIDEMIOLOGY AND IMMUNITY TO HERPES VIRUSES, THEY DISCUSSED LESSONS LEARNED FROM VACCINE DEVELOPMENT TO OTHER VIRUSES AND INCLUDING ON GOING WORK DEVELOPING APP EBV VACCINE. THEY HAD DISCUSSIONS IN THE CHALLENGES AND VACCINE DEVELOPMENT AND FORMULATION, TESTING, AND IMPLEMENTATION. IT'S A WORTH WHILE ENDEAVOR AT THIS TIME. THE MEETING WAS OPEN TO THE PUBLIC AND A STATE OF THE SCIENCE PAPER WAS GENERATED. NEXT SLIDE, PLEASE. THE SCOPE AND EXPECTATIONS OF THE RFA. LIKE TO PERFORM RESEARCH TO BETTER DEFINE THE INITIAL STEPS OF INFECTION WITH KSHB AND THE PRIMARY MEANS OF PERSON TO PERSON TRANSMISSION AND DIFFERENT POPULATIONS THAT CAN BE TARGETED WITH A VACCINE. IDENTIFICATION AND A EVALUATION OF KSHV STRUCTURAL AND NON STRUCTURAL TARGETS AND FOR A POTENTIAL KSHB VACCINE. AND DEVELOPMENT OF ANIMAL MODELS AND TO STUDENTS A PROTOCOL VACCINE AND TESTING OF CAP DATES AND STUDIES TO ASSESS HOW THE ADVOCACY OF A PROMISING VACCINE CAN BE OPTIMIZED, FOR PEOPLE WITH HIV. OPTIMIZIZATION AND STANDARDIZATION OF DETECTION METHODS. THE OVER ALL GOAL IS TO EXPAND THE RESEARCH SCOPE AND LEVERAGE THEY MADE THROUGH THE PREVIOUS RF A AND TO SUPPORT BASIC AND TRANSLATIONAL RESEARCH THAT WILL GUIDE THE DEVELOPMENT OF A VACCINE. NEXT SLIDE, PLEASE. WE PERFORMED A PORTFOLIO ANALYSIS FORTIS CAL YEAR '21 AND '22. OVER TWO ACTIVE RESEARCH PROJECT GRANTS AND NIDCA AND ADDRESSING KSHV VACCINE DEVELOPMENT. THE NCI HAS 56 FINANCED GRANTS THAT IN SOME WAY ADDRESS K IS SHV RELATED RESEARCH, NINE OF WHICH WERE FUNDED THROUGH THE PREVIOUS RFA. SIX NCI FUNDED GRANTS ADDRESS ISSUES SUCH AS VIROLOGY, EARLY INFECTION, ET CETERA, AND THAT COULD POTENTIALLY BE IMPORTANT IN VACCINE DEVELOPMENT. OTHER ICs IN THE PORTFOLIO FUNDED 17 GRANTS THAT IN SOME WAY ADDRESS KS OR KSHV AND WHEN COMPARED TO FISCAL YEAR 2015 AND 2016. NEXT SLIDE. PLEASE. THEY ARE PROPOSING A $3 MILLION BUDGET FOR EACH OF TWO RECEIPT DATES WITH A 15 MILLION OVER ALL REQUESTED FOR FIVE YEARS AND FOR EACH OF TWO RECEIPT DATES. WHICH WOULD INCLUDES $30 MILLION TOTAL THIS WOULD SUPPORT THREE TO FOUR AND THE CONCEPT HAS BEEN REVIEWED BY THE OAR AND DEEMED AIDS APPLIANCE. A UO1 MECHANISM IS BEING PROPOSED PRIMARILY BECAUSE OF THE BREADTH OF INTEREST IN COMPLEXITY THE SCOPE OF SCIENCE AND NEEDS TO BE CATALYZED THROUGH THIS INITIATIVE AND INTERNATIONAL PARTNERSHIPS IN LOW AND MIDDLE INCOME COUNTRIES WILL BE FACILITATED BY PROGRAM ENGAGEMENT IN ORDER TO OPTIMIZE SUCCESS. NEXT SLIDE, PLEASE. >> THANK YOU, REBECA. LET'S GET IT STARTED IN DISCUSSION. >> SURE. SO THANK YOU, REBECA THAT WAS A NICE PRESENTATION. Dr. DOROSHOW AND HE WASN'T ABLE TO MAKE THE MEETING BUT HE REVIEWED THE CONCEPT STATEMENT AND THE POWER POINTS AND PROVIDED FEEDBACK OVER E-MAIL. SO IN GENERAL, THE COMMUNITY MEMBERS WHICH REPRESENTS A MULTI-COLLABORATIVE EVENT ACROSS THE NCI DIVISIONS AND CENTERS. WE THOUGHT THAT THE FOCUS OF THE RFA IS CERTAINLY HIGHLY IMPORTANT IN THE NEED IS REALLY GREAT, ESPECIALLY IN THE SUB ZAHAR AN AFRICA. WE GOT THAT THERE WAS A LOGICAL PROGRESSION AND A STRONG FOUNDATION FOR THE DEVELOPMENT OF THIS RFA AND INCLUDING HAVING THIS MULTI-DISCIPLINARY MEETING ON THIS TOPIC AND RECOMMENDATIONS FROM THE BSA AD HOC COMMITTEES TO ADDRESS THE KSHB AND ALSO THE CURRENT WAVE OF RESEARCH ON THE DEVELOPMENT OF OTHER TYPES OF VACCINES AND FURTHERMORE SOME OF THE ATTRIBUTES OF THE VIRUS MAKES IT FEASIBLE TO TARGETED FOR A VACCINE. AND FINALLY THE PORTFOLIO ANALYSIS I THINK DEMONSTRATED THAT THE PROPOSAL, THIS PROPOSED RFA WILL FILL A GAP OR BE COMPLIMENTARY TO OTHER EXISTING FUNDINGS FOR RESEARCH ON THIS AREA. WE DID HAVE OF A FEW CONCERNS WHICH I THINK WERE ADDRESSED BUT REBECA AND BOB, ONE WAS THE POTENTIAL OVERLAP BETWEEN TARGET AREAS IN THE PRIOR RFA VERSUS THE PROPOSED RFA BUT WE WERE SURE THAT THIS RFA IS THAT DEVELOP AND THE VACCINES AND WE HAVE QUESTIONS AND WHETHER THE RESULTS FROM THE PRIOR RFA OUR INVESTIGATORS WHO ARE ABLE TO SECURE FUNDING AND WHAT REBECA HAD MENTIONED IS THAT PROBABLY THE INITIATION FEE PROPOSED RFA WOULD PROBABLY OCCUR WHILE THE PRIOR RFA RESULTS ARE BEING GENERATED. WE, I THINK, Dr. DOROSHOW HAD QUESTIONS ON THE WORK OF THE EVB EPSTEIN BAR VIRUS VACCINES WILL HELP INFORM THE KSHV VACCINE AND IN DEED THE RESPONSE WAS YES. AND FINALLY, OR I GUESS NOT FINALLY BUT THE OTHER RECOMMENDATION THAT WE HAD IS THAT THERE'S A PROPOSAL TO GET THE UO1 INVESTIGATORS TOGETHER TO SHARE INFORMATION WITH EACH OTHER BUT WE THOUGHT IT MIGHT BE GOOD TO OPEN IT UP TO OTHER INVESTIGATORS THAT HAVE CONDUCTED RESEARCH IN THIS PARTICULAR AREA. AND THEN FINALLY, THERE WAS A QUESTION AS TO WHETHER CLINICAL TRIALS ARE GOING TO BE REQUIRED FOR THIS RFA AND THE RESPONSE THAT IS THE CLINICAL TRIALS WILL BE OPTIONAL. SO, THAT IS IN SUMMARY OUR -- WHAT WE RECOMMENDED AND YOU KNOW, WHAT WE FELT ABOUT THE RFA AND WE'RE VERY SUPPORTIVE OF IT. >> I HIGHLIGHTED YOUR COMMENTS BUT IF YOU HAVE ANY ADDITIONAL COMMENTS. >> YEAH, NO, I THINK IT'S REALLY WELL DONE BACKGROUND AND PRESENTATIONS OF THE NEED AND YOU KNOW, EARLIER TODAY WE HEARD ABOUT FUNDINGS FORCES AND HOW THIS GETS FUNDED IS A LITTLE BIT DIFFERENT AS WELL WHICH IS FAVORABLE IN TERMS OF DEVELOPMENT OF THE VACCINE. THE THING, THE OTHER QUESTION I HAVE OVER TIME IS THIS IS A MAJOR ISSUE FOR SUB ZAHAR ANT AFRICA AND FOLKS HIV NEGOTIATE IT TIVE AND THEY AGE IN THE UNITED STATES AND I DON'T THINK WE KNOW THE ANSWER TO THAT YET SO HOPEFULLY DEVELOPMENT OF A VACCINE WOULD GENERATE A VACCINE THAT'S AFFORDABLE AND I MEAN, WE NEED THE VACCINES TO THE VACCINE FIRST. >> WE CLARIFY IT'S CLINICAL TRIALS OPTIONAL AND THAT'S ALL I HAVE TO ADD. >> YOU ARE MUTED. >> >THANK YOU.NICE PRESENTATION ANY TIMELY. I WONDER IF YOU HAD THOUGHT ABOUT COLLABORATIONS WITH THE NIEDCR BECAUSE ONE OF THE IMPORTANT ASPECTS OF ORAL KS, AS YOU KNOW, IS ASSOCIATED WITH HIV POSITIVE INDIVIDUALS AND THAT WOULD BE A NICE COLLABORATION TO BUILD ON. BUT, ONE OF THE THINGS THAT I AM THINKING ABOUT, AS YOU WENT THROUGH THE PRESENTATION, WAS THAT YOU HAVE ABOUT IT'S 80% ZERO POSITIVE. IN THE EVENT THIS VACCINE MATERIALIZES, TRYING TO THINK ABOUT HOW THIS WOULD BE SAY SOLVED IN TERMS OF TRANSMITTING TO INDIVIDUALS WHO REALLY NEEDS THE VACCINE, HAVE YOU THOUGHT ABOUT HOW THIS MIGHT BE WORKED OUT IN TERMS OF COLLABORATING WITH GOVERNMENTS AND THESE COUNTRIES AS WELL AS CHINESE GOVERNMENTS? HAS THERE BEEN DISCUSSIONS THAT HAS BEEN ON GOING WITH THIS? >> WELL, AS FAR AS COLLABORATION WITH THE NIDCR WHEN WE STARTED THIS INITIATIVE, WE DID WORK WITH THE NIDCR INITIALLY BUT THERE WERE PROGRAMMATIC ISSUES THAT PUT IT OUT OF THEIR REALM OF PARTICIPATION. SO WE'VE MOVED FORWARD I BELIEVE WE HAVE TO MOVE DOWN THE PIPELINE BEFORE WE CAN START CERTAINLY WILL WORK THROUGH NCI AS COLLABORATIVELY AND AS FORWARD-THINKING AS WE CAN POSSIBLY BE. TO GET THIS VACCINE, IF DEVELOPED, TO THE POPULATIONS THAT MOST NEED IT. I THINK THAT'S THE VALUE OF DOING THIS RESEARCH FOR VACCINE THAT PROBABLY WOULDN'T BE DEVELOPED COMMERCIALLY. >> I HAVE ONE OTHER COMMENT. IS THAT OKAY? >> YES, PLEASE. >> ONE OF THE OTHER THINGS THEY ARE THINKING ABOUT IS THIS VIRUS IS DIFFERENT TO EVE OR ECV THAT EFFECTS MOST OF THE OF THE POPULATION AND YOU HAVE A LARGE NUMBER OF ONCO GENETIC OR RF AS WELL AS QUEEN'S THAT ARE INVOLVED IN IMMUNE EVASION. DO YOU REALLY THINK WHICH AT THE POINT WHERE WE ARE READY TO START PUTTING EFFORT INTO THE DEVELOPING THE VACCINES WITH THIS HUGE KNOWLEDGE GAP THAT IS EXISTING CURRENTLY FOR THE DEVELOPING SUCH A VACCINE? >> I'M GOING TO SHOOT THAT ONE OVER AND. >> YOU KNOW ONE CAN ALWAYS SPLIT FOR THESE THINGS AND WE HAVE ENOUGH KNOWLEDGE AT THIS POINT WE CAN MOVE FORWARD. WE HAVE A PRETTY GOOD IDEA OF SOME OF THE SURFACE PROTEINS THAT IT'S ONLY TRANSMITTED IN CERTAIN SETS SO ONE HAS THE SENSE THAT ONE MAY NOT TO TWEAK THE IMMUNE RESPONSE TO THIS VIRUS THAT MUCH TO HAVE AN EFFECTIVE VACCINE. WE WON'T KNOW UNTIL WE DO IT BUT I THINK IT'S WORTH WHILE TO GIVE IT A SHOT AND WE LEARN ABOUT THE BIOLOGY FOR DEVELOPING A VACCINE. >> Dr. Flaherty: CAN YOU MAKE A MOTION? >> I MOVE TO VOTE. I MOVE TO APPROVAL. >> CAN I GET A SECOND. >> SECOND, PLEASE. THANK YOU, MARK. >> Dr. Flaherty: OKAY. ANY FURTHER DISCUSSION? MOTION IS FOR APPROVAL. AND YOUR PRESENCE ON CAMERA IS VOTED APPROVAL. SO YOU NEED TO RAISE YOUR HAND OR VOICE DISAPPROVAL IF YOU ARE VOTING IN THAT DIRECTION. I SEE YOU ARE HERE NONE. ANY ABSTENTIONS? NO. >> IT'S UNANIMOUS. >> THANK YOU. >> WE'VE REACHED THE POINT OF BREAK. THANK YOU VERY MUCH. FOR THAT REPRESENTATION AND DISCUSSION. I THINK WE -- IT'S SAFE TO SAY WE INVESTED SOME OF OUR BREAK IN THE Q&A THAT FOLLOWED JIM'S PRESENTATION LET'S SHRINK OUR BREAKDOWN TO FIVE MINUTES. WE HAVE TO SOME HAVE MAUD' CO T. >> Dr. Flaherty: WITH SAM AND JENNIFER AND ALL THREE WITH THE DISCUSSION OF CONCEPT AND SUZANNE COULDN'T JOIN US TODAY FOR THE MEETING. WE HAVE THE DISCUSSION AND GET US STARTED WHEN WE GET TO THAT POINT AND SAM AS YOU CAN SEE IS WITH US SUL. FOR TARGETING PROTEINS IN CHILDHOOD CANCER. THE OTHER MEMBERS OF THE TEAM WILL BE ON FOR QUESTIONS AND ANSWERS AFTERWARDS. FIRST POINT I WANT TO EMPHASIZE, IS THE IMPORTANCE OF ACTIVE TARGETED AGENTS, HAD WE HAVE ACTIVE AGENTS FOR A CANCER WE KNOW WHAT TO DO IN ORDER TO IMPROVE OUTCOMES FOR CHILDREN FOR CHILDHOOD ALL LOOKING ON FOR 2000 ONWARD THERE'S A 50% DECLINE IN MORTALITY WE HAVE INHIBITORS AND CAR T CELLS ARE AVAILABLE IN THE WE SEE THIS DECLINE FOR NON-HODG NON HOW MUH LYMPHOMA AND CD TARGETED 20 AND I AM H20 ANDOTHERS AND FINALLY N LYMPHOMA 80% DECLINE OF MORTALITY AND ACTIVATIONS AND LOOKING AVAILABLE IN THE LAST 10 YEARS. WE CAN IMPROVE THAT OUTCOME WHEN WE HAVE THESE ACTIVE NEW TARGETED AGENTS. IT'S A DIFFERENT STORY WHEN YOU LOOK AT SOFT TISSUE CANCER, CANCER LIKE SARCOMA AND WE LOOK AT BONE CANCER AND THOSE INCLUDE CANCERS LIKE OSTEO CAR COMA SO IT EMPHASISES NEEDED FOR CAN ZAR AND IN ORDER TO CURE MORE WITH THESE CANCER AND MANY OF THESE HARD TO TREAT CANCER WHICH HAS BEEN LITTLE PROGRESS ARE DRIVEN BY FUSION ONCA PROTEIN. IT BUILDS UPON THE NCI MOONSHOT INITIATIVE. THERE WERE NINE GRANTS U54 GRANTS IN SIX DIFFERENT FUSION ONCA PROTEINS AND STUDY FROM REMODELING, PHASE SEPARATION, MODEL DEVELOPMENT, PRO TAX AND APPLY STRATEGIES AND STUDYING CRITICAL DEPENDENCIES AND PROGRESS WAS MADE. Dr. BERTAGNOLLI DESCRIBED THE ADVANCES, THE IDENTIFICATION OF ETV6 IS A CRITICAL DEBEN SEE AND OTHER OTHER ADVANCE AND I DON'T HAVE TIME TO GO THROUGH ALL OF THESE BUT JUST TO MENTION A FEW. KIM AND HER TEAM SHOWED THAT TRIM 8 REGULATES EWS51 PROTEIN LEVELS AND EITHER TOO MUCH EWS51 OR TOO LITTLE IS DETERMINED BY THE ACTIVITY CAN BE TOXIC TO EWING SARCOMA CELLS AND AS WELL, JOHN BUSHWELLER HAS IDENTIFIED SMALL MOLECULES THAT STABILIZE FLIGHT 1 AND ANOTHER TRANSCRIPTION FACTORS THIS SHIFTS THE EQUILIBRIUM AWAY FROM DNA BINDING AND INHIBITS THE ACTIVITIES OF THESE TRANSCRIPTION FACTORS AND ANOTHER EXAMPLE, CHARLES MULLIGAN AND HIS U54 TEAM IDENTIFIED A CRITICAL DEPENDENCY AND REARRANGED LEUKEMIA AND THIS IS SOMETHING THAT CAN HAVE IMMEDIATE CLINICAL TRANSLATION BECAUSE MODELING AND CAN BE USED FOR DRUG SCREENING. WE DID HAVE EX INTERPRETTAL SCIENTIFIC CONSULT APARTMENTS TO ADVISE US ON NEXT ACCEPTS TO FOLLOW THROUGH THE CONSORTIUM. WHERE NCI MAKES CONTRIBUTIONS AND ANOTHER DIVERSIFYING THE PROTEINS INCLUDED IN FUTURE EFFORTS AND THEY RECOMMENDED APPLYING STATE OF THE ART METHODS TO DIRECTLY TARGETING INFUSION ONCA PROTEINS AND THEY HAVE SUCH A STATE IT'S POSSIBLE TO -- AND INNOVATIVE DRUG DEVELOPMENTS TO ALL OF THE INVESTIGATORS THAT ARE MEMBERS OF THE NETWORK AND TO DO DILIGENCE IN THE REASSURE OURSELVES IT'S SCIENTIFIC OPPORTUNITIES ARE AVAILABLE AND THERE'S INTEREST IN THE RESEARCH COMMUNITY WE ORGANIZED WEBINAR SERIES LAST YEAR ON NOVEL CHEMICAL APPROACHES FOR TARGETING FUSION ONCA PROTEINS AND WE HAD 1,000 HIGH LEVEL OF INTEREST IN THIS TOPIC AND REALLY THE -- WE CAME AWAY WITH MORE ENTHUSIASM I DON'T HAVE TIME TO GO THROUGH THE OPPORTUNITIES BUT THE METHODS FOR PROTEIN DEGRADATION FOR SCREENING, CO VARIANT INHIBITORS AND ALL OF THESE THINGS CREATE AN OPPORTUNITY FOR PROGRESS. SO, THE NETWORK THAT WE'RE PROPOSING HAS TWO COMPONENTS. THE FIRST IS FOR PROJECTS TO BETTER UNDERSTAND THE MECHANISMS OF FUSION DRIVEN ONCAGENESIS AND SO THOSE UO1 GRANTS STUDY THE PATHWAY BY WHICH THE FUSIONS CAN CAUSE CANCER, WHAT'S THEIR COMPLEXES THAT THESE FUSION ONCOPROTEINS ARE INVOLVED WITH AND THE INTERACTIONS WITHIN THE COMPLEX AND WHAT ARE THE ROLES LIKE NON CODING RNAs OR IN THE FUNCTION OF THESE FUSION ONCOPROTEINS AND THE SECOND ARE THE NEXT GENERATION CHEMISTRY CENTERS AND THESE ARE LARGER GRANTS THAT ALLOW SEVERAL SEEMS TO WORK TOGETHER AND WITH COMPLIMENTARY RESEARCH AND EXPERTISE TOWARDS A COMMON GOAL AND ANY OF THAT COMMON GOAL IS ACTIVITIES FOR THESE AND IDENTIFYING INHIBITORS OF FUSION ON CO PROTEIN ACTIVITY AND EITHER DIRECTING INHIBITORS BLACKING CRITICAL INTERACTIONS AND OR DEGRADING THE FUSION ON CO PROTEIN OR THE CRITICAL DEPEN DEN SEIZE. THESE A SCHEMATIC OF THE HOW WE I AM VISION OF THE NETWORK OF STEERING COMMITTEE WITH THE PIs OF THE UO1 AND THE UM1s. THE UM1s AND THE UO01s HANK OR THE NETWORK BUT OTHER GRANTEES CAN BE ASSOCIATE MEMBERS OF THE NETWORK AND THESE ARE STATION FUSION THROUGH OTHER NCI FUNDED GRANTS OR THESE STUDYING FUSION ONCOPROTEINS AND INCLUDING PATIENTS ADVOCATES AS WELL AND BETWEEN THE UM1 COMES THE RESEARCH TEAMS OUTSIDE OF THE NETWORK EVEN AND THE UM1 BUDGE LET'S HAVE 15% OF THEIR OVER ALL BUDGET TO APPLY THE STRATEGIES WITH INTERACTIONS BETWEEN THE UO1 AND THE UM1s. THE AS A RESULT OF OUR DISCUSSIONS WITH THE BSA SUBCOMMITTEE WE WANT TO -- THE NUMBER ONE IS FOCUS OF PROTEIN THAT HAVE A HIGH-RISK OF FAILURE AND LITTLE PROGRESS IN IDENTIFYING TARGETED AGENTS AND WHILE PARTICULARLY ENCOURAGED APPLICATIONS WHERE THEY SOLID TUMORS AND BRAIN TUMORS AND EXCLUDE FUSION O ON CO ONCOPROTD DATA SHARING AND COLLABORATE WITH OTHER NCI PROGRAMS SUCH AS THE CHILDHOOD DATA INITIATIVE TO ENSURE USABILITY AND ACCESSIBILITY AND SHAREABILITY OF THE DATA. IN TERMS OF THE BUDGET AND LOGISTICS, THERE'S SEPARATE RFAs, ONE FOR THE U01 AWARDS AND THEY WERE TARGETING 325,000 DIRECTING CALLS FOR THESE AND THE RFA FOR THE UM1 AWARDS, WE ENVISIONED TWO UM1 AWARDS EACH WITH $1.5 MILLION AND DIRECT COST AND WE THE 15% OF THE BUDGET BEING RESTRICTED FOR COLLABORATIVE PROJECTS IN YEARS TWO THROUGH FIVE. WITH $8.3 MILLION ANNUALLY FOR FIVE YEARS FROM FY24 TO FY28. SO, OUR MARKERS OF SUCCESS NUMBER ONE IS TUB THREE, NEW TECHNOLOGIES AND STRATEGIES IDENTIFYING FOR TARGETING FUSION ONCOPROTEINS OR THEIR DEPEN DEN SEIZE AND FINALLY, IDENTIFYING AND DEVELOPING CHEMICAL PROBES TOOLS OR ADVANCE LEADS THAT CAN BE OPTIMIZED TO NEW DRUG CANDIDATES SO THAT'S REALLY WHAT SO MY COLLEAGUES WILL BE AVAILABLE TO ADDRESS QUESTIONS THE BSA MEMBERS MAY HAVE. >> THANK YOU. DO YOU WANT TO GET US STARTED. >> HI, MALCOLM, THANK YOU FOR THAT. IT WAS A WONDERFUL PRESENTATION AND NICELY INCORPORATED SOME OF THE DISCUSSION TOPICS THAT WE HAD WHEN WE MET. WE WERE VERY ENGAGE IN ENTHUSIASTIC ABOUT THE CONCEPT AS YOU HAVE HEARD AND IT REALLY BUILDS UPON THIS SUCCESS AND LESSONS LEARNED IN THE U54 CONSORTIUM, THE QUESTION IS WHAT IS THE NEXT STEP. THE WE ARE NAR SERIES SHOWED A HIGH LEVEL OF ENGAGEMENT AND THIS IS JUST FELT TO US VERY LOGICAL AND WE WERE EXCITED BY THE POSSIBILITY OF BRINGING THE UM1 MECHANISM INTO NCI WHERE WHY THINK IT'S A COMMON MECHANISM FOR FUNDING. IT'S THE MECHANISM TO FUND THE CTSAs WHICH SEVERAL OF US ARE VERY FAMILIAR WITH AND THE NICE PART ABOUT THE UM1 MECHANISM IS IT'S REALLY FLEXIBLE. SO THIS PLUS THE INCENTIVIZED 15% COLLABORATIVE RESOURCES REALLY SEEM TO US LIKE THE RIGHT THING TO DO. WE REALLY HAD A COUPLE OF QUESTIONS AND CLARIFICATIONS WHICH WERE DISCUSSED IN TERMS OF OVER ALL STRUCTURE AND INTERACTIONS WITH BOTH BETWEEN UM1 AND UO1 AND RO1s, INTRAMURAL COMMUNITY IT ALL SOUNDS RIGHT. THE DATA ISSUE IS LARGE, I'LL LET SAM WEIGH IN ON THAT BECAUSE IT'S REALLY HIS AREA OF EXPERTISE. UP WITH OF THE IDEAS WE GOT EXCITED ABOUT IS LEARNING FROM THIS SUCCESS OF THE N3C EFFORT IN N CAT WHERE THERE WAS A REQUIREMENT DURING COVID TO SHARE ALL THE ELECTRONIC HEALTH RECORDS WITH THE NIH IN ORDER TO SUPPORT COVID RESEARCH. THERE REALLY ISN'T ANY REASON WHY NCI CAN'T LEVERAGE SUCH A EFFORT WITH THE COMPREHENSIVE CANCER CENTERS SO THE CANCER CENTER CONSORTIUM, WHEN THE TIME IS RIGHT, WHEN THE QUESTION IS RIGHT, YOU CERTAINLY HAVE THE POLITICAL CAPITOL TO DO IS SUCH AND I THIS I IT COULD REALLY CAPITALIZE WELL ON THE OTHER EFFORTS WE HEARD THIS MORNING AND NOT I THOUGHT THE HIGH LEVEL, LET'S NOT FOX SOMETHING THAT'S ALREADY SOLVED AND LET'S ATTEND TO THINGS THAT ARE STILL BROKEN IS A REALLY PRAGMATIC RESPONSE. YOU KNOW, SUZIE, SAM AND I WERE ALL VERY SUPPORTIVE AND I'LL LET SAM SPEAK NOW. >> THANK YOU. OBVIOUSLY VERY ENTHUSIASTIC ABOUT THIS. ESPECIALLY AS A SPEED FROM THE PEDIATRICONCOLOGIST AND ALL THET FROM THIS PROGRAM SO FAR. OBVIOUSLY I'VE BEEN CONCERNED ABOUT DATA SHARING AND WE NEED TO SEE EVERY OPPORTUNITY TO COLLECT AND AGO AGREE GATE AND HARMONIZE DATA LIKE THIS. WE HAD A DISCUSSION ABOUT THE DIFFERENT MECHANISMS THAT ARE IN PLACE FOR A FOR FOR AGGREGATINGO SHOW HOW RESEARCH OUTPUT FROM THIS PROGRAM CAN BE HARNESSES AND REPURPOSES FOR OTHER FOLKS THAT WANT TO USE THE DATA FOR THEIR OWN RESEARCH. THIS IS A GREAT OPPORTUNITY HERE AND ACROSS ALL OF OUR PROGRAMS OBVIOUSLY. SO THANK YOU FOR LETTING ME BE A PART OF THIS DISCUSSION. >> THANK YOU. OPEN FOR FURTHER DISCUSSION. >> WHAT HAPPENS TO THE CURRENT PROGRAM? IS THIS A REPLACEMENT FOR THE CURRENT MOONSHOT PROGRAM? >> YEAH, THE CONSORTIUM, THESE WERE MOONSHOT PROGRAMS FIVE YEAR AWARDS AND THEY WERE DONE TWICE AND SO SOME OF THE AWARDS WERE, THEY'RE ENDING ONE YEAR APART BUT THEY WERE FIVE YEAR AWARDS AND SO, IN SOME WAYS, THIS BUILDS UPON THAT AND WE'LL BE A SUCCESS FOR THAT AND THOSE AWARDS THEMSELVES WILL NOT BE ABLE TO CONTINUE. IN LOOKING AT THE KIND OF POINTS THAT THIS RFA WOULD BE POINTING TO, I'M SURPRISED THAT THERE WAS NOT ANY MENTION OF AN IMMUNE LOGICAL APPROACH BECAUSE FUSION PROTEINS ARE GOOD TARGETS AND THEY CAN ACTUALLY BE HIGHLY SPECIFIC AND THEY DON'T NEGATE THE DISTRICTED KIND OF SMALL MOLECULE APPROACH THAT IT'S TALKING ABOUT. BECAUSE I DON'T KNOW MUCH ABOUT THESE TUMORS AND WE HAVE AFTER EFFORT WITHIN NCI, PEDIATRIC IMMUNO NETWORK NOW THAT IS SPECIFICALLY APP APPLICATION THAT WOULD BE RIGHT WITHIN WHAT THOSE PROGRAMS WERE AIMING FOR. IS THERE SOMETHING ABOUT THESE FUSION PROTEINS THAT STIMULATES AN IMMUNE SPONSOR THAT THERE'S AN ACTIVE AREA OF RESEARCH AND IN PART WE DIDN'T MENTION IT HERE SIMPLY BECAUSE OTHERS ARE ADDRESSING IT AND OTHER PROGRAMS. >> THANK YOU. >> SEEING NO OTHER HANDS, WE CAN MOVE TO VOTING. JENNY, AS THE ACTING CHAIR, IT SOUNDS LIKE YOU ARE MOVING THIS IN SUPPORTIVE DIRECTION. WOULD YOU LIKE IT MAKE A MOTION? >> I MOVE TO APPROVE. >> CAN I GET A SECOND. >> ANY FURTHER DISCUSSION? HEARING NONE. THE ASSUMPTION IS VOTE OF APPROVAL. SO LOOKING FOR ANY DIS APPROVALS BY RAISE OF HANDS OR VOICE. I SEE AND HEAR NONE. ANY ABSTENTIONS. >> IT'S UNANIMOUS. >> THANK YOU, ALL. WE HAVE A REISSUANCE RFA AND CO-OPERATIVE HAIMON TISSUE NETWORK AND Dr. CHUAQUI WILL PRESENT AND IT'S SHARED BY SHELLY IRP AND CONSTITUTED BY FELLOW ALLRIDGE AND SUSAN BAKER AND AS NOTED, SUSAN COULDN'T JOIN US FOR THE MEETING TODAY. SHELLY AND NELLY ARE WITH US. AND I'LL JUST MENTION NOW AT THE OUTSET, THIS IS A LIMITED COMP COMPETITION AGREEMENT AT THE INSTITUTIONAL OR INTEREST LEVEL AS A CONSTITUTION WE HAVE A NUMBER OF CONFLICTS AND ABSTENTIONS THAT COME UP AT THE END. SIX OF OUR MEMBERS WILL BE ABSTAINING FROM THE VOTING PROCESS. AS WELL AS DISCUSSION WHEN WE GET THERE. SO JUST A FLAG THAT AS NON UNUSUAL FOR LIMITED COMPETITION INSTITUTIONAL LEVEL AWARDS LIKE THIS. SO WITH THAT SAID, RODRIGO, GO AHEAD WITH THE PRESENTATION. >> SORRY, DO YOU HAVE A QUEST QUESTION? >> SO THE COMPARATIVE TISSUE NETWORK IS AN NCI SUPPORTED RESEARCH WHOSE MAIN GOAL IS INFORM PROVIDE HIGH-QUALITY SPECIMEN MAINLY FOR BASIC AND EARLY TRANSLATIONAL RESEARCH AS WELL AS ASSAY DEVELOPMENT. NEXT SLIDE. THE PROBLEM HAS BEEN FUNCTIONING WITH HIGH PRODUCTIVITY SINCE 1987 AND HAS A WELL STRUCTURE IN CONSISTING OF SIX DIVISIONS, FIVE ADULT DIVISIONS THAT DISTRIBUTE SPECIMENS ACCORDING TO THE GEOGRAPHIC LOCATION OF THE THE ADULT DIVISIONS WORK WAYS BETWEEN ONE AND AND HAVE SIGNIFICANTLY CONTRIBUTED TO BIO SPECIMEN SCIENCE AND BIOBANKING. IT'S A UNIQUE REPOP TORI UNLIKE ANY FUNDED BY THE NCI. IF YOU LOOK AT THE RIGHT COLUMN, IT IS BASED AN PROSPECTIVE PROCUREMENT MODEL AND IN RESPONSE TO AN INVESTIGATOR REQUESTING THOSE SAMPLES. WITH LIMITED STORING. THE PROSTHETIC PROCUREMENT ALLOWS THE PROCESSING OF THE SAMPLES TO BE CUSTOMIZED TO THE INVESTIGATORS NEEDS AND THERE'S FREQUENT COMMUNICATION BETWEEN INVESTIGATOR AND THE CHTM. IN THE NETWORKING ON THE OTHER HAND, ALLOWS FOR A WIDE RANGE OF SAMPLES TO BE COLLECTED INCLUDING RARE SAMPLES. THEY ARE PROVIDED WITH BASIC DAMNGRAPH I CAN AND HISTO PATH S REQUESTED FOR MORE DATA. FRESH AND FROZEN SAMPLES, WHICH ARE USUALLY THE LIMITING FACTOR IN BIO REPOSITORIES CONSTITUTE ABOUT 50% OF THE SAMPLES AND THAT WERE SHIPPED IN THE LAST FIVE YEARS. THE CHTN IS AN OPEN RESOURCE IN SEARCH OF THE ENTIRE SCIENTIFIC COMMUNITY WITH A LOW PRIZE, LOW BAR AND EASY ACCESS TO THE SAMPLES. NEXT SLIDE, PLEASE. SO, THE CHTN CONTINUES TO WORK WITH HIGH PRODUCTIVITY AND THIS DATA REFERENCES TO FIVE YEARS, 2017-2021 AND OVER 1800 RESEARCHERS WERE SEARCHED, THREE QUARTERS OF THEM WERE ACADEMIC INVESTIGATORS, AND MOST OF THEM ARE ONE GUARANTEE AND 23% INVESTIGATORS IN INDUSTRY AND OTHER GOVERNMENT IN INTRAMURAL DOD. ALSO, OVER 175,000 SAMPLES WERE DISTRIBUTED. YOU CAN SEE ON THE LEFT GRAPH, THE DISTRIBUTION OF SAMPLES IN THE LAST 10 YEARS, AND ON THE RIGHT SIDE, YOU CAN SEE HALF THE SAMPLES PRETTY MUCH WHY FRESH OR FROZEN. OVER 500 PUBLICATIONS WERE GENERATED DURING THIS PERIOD USING CHDN SAMPLES AND 55 PATENTS, MOST BY INDUSTRY BUT ALSO WITH CONTRIBUTIONS BY AK ACADEMIA, DESPITE THE PROBLEM HAD TO FACE SOME CHALLENGES DURING THIS PERIOD, DESPITE THE INCREASED THAT WAS APPROVED FOR FUNDING IN THE LAST RECOMPETITION, THE POLICY OF CUTS TO GRANTS OR RFAs LED TO THE CURRENT FUNDING AND LAST ONE WAS OPEN COMP FISSION AND ONE DIVISION, THE SOUTHERN DIVISION THE TEENS WAS WAS REPLACED AND IT PROCESSES THAT MEANT SIGNIFICANT EFFORTS AND DIFFERENT LEVELS INCLUDING TRAINING, AND RE-ASSIGNMENT OF INVESTIGATORS, AND LEGAL AGREEMENTS, AND HIRING. AND OF COURSE, COVID IS MOST OF SCIENCE AND IMPACTED THE PROGRAM. NEXT SLIDE, PLEASE. AS I SAY, SOME DISTRIBUTED BY CHDN AND UNIVERSITIES IN THE IN CON HAVE THE CENTER INVESTIGATORS AND OF COURSE INTRAMURAL RESEARCHERS IN THE RIGHT-OF-WAY WE INCLUDE AND WIDE RANGE OF CURRENT HIGH-THROUGHPUT TECHNOLOGIES AND IN WHICH SAMPLES WERE USED FIVE YEARS AND ALL THE WAY TO GENOMICS AND TRANSCRIPT TOMB I CANS. DEMONSTRATING THE HIGH-QUALITY OF THE SAMPLES. LAST YEAR, THE REVIEW WAS CONDUCTED TO OUR PROGRAM FOR THE CHTN WHICH REVIEWSERS FOR BACKGROUNDS. THERE WAS A HIGH VALUE FOR THE RESEARCH COMMUNITIES AND EMPHASIZING OUR ONE GUARANTEES AND THE PROSPECTIVE MODEL PLACE A KEY ROLE IN BASIC AND EARLY TRANSLATIONAL RESEARCH AND AND THERE WAS SUPPORT FOR A LIMITED COMPETITION TO MAINTAIN THE DA BILL TEE OF THE PROGRAM AND REALLY THERE'S NO ALTERNATIVE TO THE COMMERCIAL RESOURCES CANNOT PLY THE FULL RANGE OF SERVICES AND INCLUDING THE TYPES OF SAMPLES AND THE PRICING. GENRE PROPOSING UP TO SIX AWARDS UNM GRANT AND AS I SAID THE LIMITED COMPETITION PROVIDED WE ALREADY HAVE ESTABLISHED A WELL BUILT STRUCTURE AND THE CURRENT FUNDING LEVEL IS 4.7 MILLION APE YEAR AND YOU CAN SEE AT THE BOTTOM HALF OF THE SLIDE MOST OF THE 3.7 MILLION AND COVERS THE COST OF THE PROCUREMENT AND DISTRIBUTION OF SAME POLLS AND THE REST IS USED FOR FUNCTIONS THAT SUPPORT THE OPERATIONS AND INCLUDING COORDINATION AND LOCAL ID. SO WE ARE QUESTIONING 6.2 MILLION A YEAR WITH 31 MILLION FOR FIVE YEARS FOR SIX AWARDS AND IT'S JUSTIFIED BY THE FACT THAT THERE'S BEEN SIGNIFICANT INCREASE IN DEMAND FOR MORE LABOR INTENSIVE SAMPLES. AND FRESH SAMPLES WHICH ARE ACTUALLY THE MOST LABOR INTENSIVE INCREASED DURING THE FIVE YEARS 33% REQUESTS INCLUDING CHART REVIEWS INCREASED FROM 11% TO 16% OF ALL THE REQUESTS. THERE WAS A THREE-FOLD INCREASE IN OTHER MORE DIFFICULT TO FULFILL REQUESTS SUCH AS SHORT ISCHEMIA TIME, FOR LABOR DATA, AND HIGHER HUMOR CONTENT. THERE WAS A TWO-FOLD IN THE AMOUNT OF TMAs AND THE DEMANDS FOR PROCUREMENT OF BLOOD INCREASED IN COMPLEXITY AND CTDNA AND CTCs TRIED TO. SO OUR MAIN GOAL CONTINUES TO BE TO SUPPLY THE ENTIRE RESEARCH COMMUNITY WITH HIGH-QUALITY SAMPLES. GREAT, THANK YOU, VERY MUCH. EXCELLENT PRESENTATION. WE'LL GET STARTED ON THE DISCUSSION. >> YES. SO SUZIE AND NELLY AND I MET WITH EACH AND THAT WAS RODRIGO AND AUDRYNA. THERE WAS A VERY GOOD AND THOROUGH -TZ OUTSIDE REVIEW THAT WAS DONE THAT WAS LED BY Dr. HOLLINGSWORTH AND WE TALKED ABOUT A NUMBER OF ASPECTS. WE HAD A NUMBER OF QUESTIONS THAT WERE RAISED. ONE OF THE MAJOR QUESTIONS WAS YES, THIS IS DEIDENTIFIED DATA SO WE HAD MADE ONE STRONG SUGGESTION THAT THE RFA ACTUALLY INCLUDED THAT THAT WOULD BE PART OF WHAT WAS NEEDED. THE FEELING WAS THERE'S A LOT OF GOOD DATA THAT HAS BEEN HAD A NUMBER OF ACADEMIC INSTITUTIONS, I BELIEVE IT'S BETWEEN THREE AND 400 EACH YEAR. YOU AWE 18 HUP INVESTIGATORS SO. ONE OF THE QUESTIONS IS THE COST ARE LOW AND WE'RE ALL WORRIED ABOUT COST THESE DAYS. THERE IT SHOULD BE LOOKED AT AND THERE DOING THINGS THAT I DON'T KNOW EXACTLY BUT THERE SHOULD BE THE INDUSTRY THAT USES THIS HAVE HAVE A LARGER PORTION OF THE COST AND THEN WE WERE A LITTLE -- THE GEOGRAPHIC DISTRIBUTION IF APPROXIMATE THE MATH IS TOTAL BUT ALL OF THE INSTITUTIONS ARE EAST OF THE MISSISSIPPI AND THE QUESTION IS HOW EFFECTIVE ARE WE AT DEVELOPING SAMPLING FROM A EXPANDED GEOGRAPHICAL AREA. THERE ARE PARTNERS FOR EACH ONE OF THESE GROUPS AND WE DIDN'T REALLY KNOW HOW WELL THAT WAS BEING EFFECTED. SO, WE DID FEEL THAT THE FOCUS ON FRESH AND FROZEN SAMPLES WAS PARTICULARLY APPROPRIATE. MOST PEOPLE HAVE ACCESS TO FIXED TISSUE SO WE THOUGHT IT WELCOME BACK EMPHASIZED MORE IN THE RFA. THOSE WERE MAJOR POINTS BUT I THINK NELLY MAY HAVE HAD SOME OTHER COMMUNITIES TOO THAT I HAVE MISSED. >> WELL, THANK YOU. I THINK THERE'S A LOT THAT IS VERY, VERY IMPORTANT ABOUT BIOBANKING AND IT'S EXTREMELY IMPORTANT FOR SUPPORTING RO1 TYPE OF RESEARCH AND WE HAD SOME REALLY GOOD CONVERSATIONS LOOKING ALSO AT HOW IS THE USE DEVELOPED OVER TIME AND WHAT IS REALLY PERHAPS THE GREATEST NEED FOR THIS RESOURCE AND YEAH, I THINK IT'S IMPORTANT TO CONSIDER WHICH THOUGHT FOR AN INCREASE IN THE BUDGET, THERE IS DEFINITELY A POTENTIAL TO CONSIDER THE FEE SCHEDULE FURTHER AND HOWEVER THEY ALREADY ADAPTED THAT SOMEWHAT AND I THINK THAT'S VERY HELPFUL. AND YOU KNOW, MAYBE SOME STRATEGIC PLANNING WOULD BE HELPFUL FOR THE FUTURE OF THINKING HOW COULD THIS BESTFUL FIST IN THE SCOPE OF OTHER BIO REPOSITORIES THAT EXIST AND I THINK OF THERE'S NO COMMERCIAL SUPPORTED BUT FIXED TISSUE ARE MORE EASILY AVAILABLE THESE DAYS AND I THINK THAT THIS EMPHASIZE ON FRESH FROZEN AND OTHER SAMPLES THAT ARE REALLY DIFFICULT TO OBTAIN SOMETHING WHERE THERE'S A UNIQUE NICHE FOR THIS RESOURCE. SO, THERE WAS ALSO MENTIONED OF INCREASING DIGITAL PATHOLOGY WHICH THE PRIOR REVIEWERS LIKED AND THOUGHT IT WOULD BE HELPFUL. THERE WERE SOME PLANS OF ADDITIONAL FOLLOW-UP IN CHART OBSTRUCTION BY THE PRIOR REVIEWERS THOUGHT IT WAS NOT THE BEST USE OF MONEY FOR THIS NEXT RFA SO OVER ALL, ALSO, I DON'T WANT TO SAY I'VE BEEN IMPRESSED THAT THIS RESOURCE HAS BEEN REALLY ABLE TO SERVE THE BROADER COMMUNITY ABOUT 40% OF THE CURRENT USE IS GOING TO THE INSTITUTIONS THAT HOLD ONE OF THESE GRANTS BUT 60% DON'T AND MAYBE FURTHER ADVERTISING AND MAKING THIS KNOWN VERY WELL, NOT JUST ON THE WEBSITE, WILL HELP TO MAKE SURE THAT IT CONTINUES AS A VERY IMPORTANT RESOURCE. SO, OFFER ALL WE REALLY APPRECIATE THE RESPONSIVENESS AND THE PROVISION OF EXTRA DATA. WE DO FEEL LIKE DIVERSITY IN REPRESENTATIVENESS IS IMPORTANT AND THAT WAS NOT SOMETHING YET CONSIDERED. >> THANK YOU. ANY FURTHER DISCUSSION? GO AHEAD, MARC. >> I MIGHT HAVE MISSED IT BUT IN TERMS OF THE REQUEST FOR INCREASING THE BUDGET, IT A PREPORTION AIM CREASE OR IS THERE MORE EFFICIENCY GAINED AND MOST OF THAT BUDGET GOES INTO TISSUE ACQUISITION OR HOW DOES THAT PLAY OUT? IN TERMS OF THAT INCREASE. ADMIN COST VERSUS SPECIMEN? >> THE PROCUREMENT AND LABOR TO DISTRIBUTE THE SPECIMENS, YEAH. >> MAYBE WE COULD ADD AT THIS POINT THERE'S AN EQUAL FEE FOR FIXED ISSUE VERSUS FRESH FROZEN TISSUE SO THAT WOULD BE AN OPPORTUNITY TO CONSIDER IF THERE IS A GREATER WORKLOAD INVOLVED TO, YOU KNOW, NOT TO MICRO MANAGE THIS OF COURSE. >> I'M UNCLEAR, IS THIS JUST STANDARD TISSUE BANKING? YOU KNOW, AMONG PATIENTS WHO GETS NIPPING REMOVED DURING CLINICAL CARE? OR IS THERE ANY OTHER CRITERIA THAT ARE PUT ON WHAT TISSUE IS COLLECTED, TISSUE OR BLOOD IT SOUNDS LIKE? >> IN THIS SIX PRIMARY INSTITUTIONS, ANY OF SURGERY THAT GENERATES IS CONSIDERED, A CANDIDATE TO BE A SAMPLE AND ARE STORED BECAUSE MOST OF THE MOST IS PROTUREMENT. >> THANK YOU. >> NO OTHER HANDS. WE CAN MOVE TO VOTING. SO, SHELLY IT SOUNDS LIKE YOU ARE IN A FAVORABLE DIRECTION, WOULD YOU LIKE TO MAKE A MOTION? >> YES, I WOULD LIKE TO MAKE A MOTION TO APPROVE. PARTICULARLY WITH THE ADDITION OF. >> I'M TRANSLATE THAT INTO A MOTION TO CONCUR SINCE THIS IS A REISSUANCE. >> CAN I GET A SECOND ON THAT? >> ANY FURTHER AND HE? >> OTHER OF HE DIDN'T JOIN THE IN-PERSON AND WHO HAD A CONFLICT AND. >> L YOU HAVE THE FIVE EXTENSIONS I GATHER. >> YES, I'LL ALL THEIR NAMES. >> WHO HAVE OBTAINED. SO THE VOTE IS 21 CONCUR AND ZERO NAYs AND FIVE ABSTENTIONS. >> Dr. Flaherty: GREAT. THANK YOU. ONE MORE CONCEPT A NEW RFP. AND SBIR CONTRACT TOPICS AND Dr. MONDAY E MONIQUE POND WILL T AND SUPPORTED BY MYSELF AND DAVID ALL OF WHOM WERE ALL PRESENT FOR THE DISCUSSION WHEN THE TIME COMES. SO, MO MONIQUE, GO AHEAD WITH YR PRESENTATION. >> GOOD AFTERNOON, EVERYONE, THANK YOU FOR YOUR TIME. I'LL BE PRESENTING THE SBIR TOPICS FOR FY2024 ON BEHALF OF OUR OFFICE. AND STTR PROGRAM IS CONGRESS LEHMAN DATING SET ASIDE THAT IS REQUIRED BY FEDERAL AGENCY THAT'S HAVE RND BUDGETS THAT EXCEED A CERTAIN SIZE. AND HERE AT NCI WE UTILIZE BOTH OF GRANTS AND CONTRACT MECHANISMS FOR FUNDING SO IN FY202222022, 20% WENT TOWARDS. WE DON'T PRESCRIBE A SET DOLLAR AMOUNT TO SPEND ON GRANTS FIRST OF CONTRACTS INSTEAD WE FOCUS ON FUNDING THE BEST TRANSLATIONAL SCIENCE AND THAT ARE HELP PATIENTS WITH CANCER. WITH THE CONTRACT MECHANISM, WE'RE ABLE TO DEFINE NARROWLY FOCUSED TOPICS THAT HAVE SPECIFIC PRODUCT DEVELOPMENT GOALS AND MILESTONES AND THIS IS IN CONTRAST TO THE GRANTS MECHANISM WHERE WE FIND INVESTIGATOR INITIATED PRODUCT DEVELOPMENT. AND I JUST WANT TO NOTE HERE THAT THE MONEY USED TO FUND THESE SMALL BUSINESS AWARDS, EITHER THROUGH GRANTS OR CONTRACTS, DOES NOT EFFECT THE RPG POOL. >> SOMETIMES TOPICS DEVELOP TO ADDRESS A SPECIFIC NEED BY THE CANCER COMMUNITY AND WE STIMULATE COMMERCIALIZATION OF PRODUCTS IN CERTAIN AREAS AND THIS WOULD BE A RELATIVELY NEW AREA OF RESEARCH WHERE WE WANT TO STIMULATE TRANSLATION OF SCIENCE INTO PRODUCTS FOR PATIENTS AND OR IT COULD BE TO SUPPORT DEVELOPMENT OF PRODUCTS THAT IS A PARTICULARLY CHALLENGING AREA OF HIGH IMAGE. LASTLY WE USED THE CONTRACT MECHANISM TO ADDRESS IMPORTANT CANCER INDICATIONS OR PATIENT POPULATIONS UNDER REPRESENTED IN OUR PORTFOLIO. SO SIMILAR TO THE GRANT APPLICATION CONTRACT PROPOSALS UNDER GO A RIGOROUS PEER REVIEW PROCESS. ONE MAIN DIFFERENCE IS CONTRACT REVIEWS ARE CONDUCTED BY THE NCI DIVISION OF EXTRAMURAL ACTIVITIES INSTEAD OF NIH CENTER FOR SCIENTIFIC REVIEW. IN ADDITION, CONTRACT PROPOSALS IN ORDER TO BE SUCCESSFUL, THEY REALLY MUST ALIGN WITH THIS SPECIFIC TOPIC AS WELL AS THE DELIVERABLES THAT ARE DETAILED IN THE SOLICITATION. SO, WHILE WE PROVIDE AND YOU PROBABLY NOTICED IN THE WRITE UPS WE HAVE AN ESTIMATE OF THE NUMBER OF PROPOSALS THAT WE MIGHT FUND UNDER A IT PARTICULAR TOPIC THEY HELP US WITH BUDGET PLANNING. IF WE DON'T RECEIVE ANY STRONG PROPOSALS FOR A PARTICULAR CONTRACT TOPIC, WE WON'T FUND ANY PROPOSALS UNDER THAT TOPIC AND THE BUDGETED FUNDING WILL JUSTING USED TO SUPPORT ADDITIONAL MAR TO BE YUS GRANT APPLICATIONS. NEXT SLIDE, PLEASE. BEFORE I PRESENT THE TOPICS I WOULD JUST LIKE TO GIVE YOU A SHORT SUMMARY OF OUR PROCESS FOR CONTRACT TOPIC DEVELOPMENT. EVERY OCTOBER WE SO MANY IS ITS NEW CONTRACT TOPIC ITEMS FROM ACROSS THE NCI DIVISION OFFICES ASK CENTERS AND WE RECEIVED THESE NEW TOPICS ITEMS FOR SUBJECT MATTER EXPERTS THIS COULD INCLUDE THE NCI DIRECTOR, DIVISION DIRECTORS, WORD PROGRAM OFFICERS AS WELL. BEGINNING THREE YEARS A. WE STARTED COM AB RATISTART GETTINS FOR TOPICS AS WELL. FOR FY2024, WE RECEIVED 18 CONTRACT TOPIC IDEAS COMMISSIONS AND THAT CAME FROM ACROSS NCI. AND AS PART OF EACH COMMISSION, TOPIC AUTHORS DO A PORTFOLIO ANALYSIS THAT DETAILS BOTH NCI AND NIH FUNDING IN THAT PARTICULAR SCIENTIFIC AREA. AND THIS ALSO INCLUDES FUNDING THROUGH SBIR OR NON SBIR MECHANISMS. THIS MISSION GOES TO OUR TECHNOLOGY ADVISORY GROUP WHERE THEY'RE REVIEWED AND DISCUSSED AND SCORED. WE HAVE TWO GROUPS, EACH FOCUSED ON REVIEWING TOPICS AND CERTAIN SCIENTIFIC AREAS. TECHNOLOGIES AND WHILE TAG 2 REVIEWS RADIATION THERAPY, MEDICAL DEVICES AND HEALTH IT TECHNOLOGIES. THESE TAGS ARE COMPOSED OF SUBJECT MATTER EXPERTS IN THE SPECIFIC AREAS FROM ACROSS NCI IN ADDITION TO THE PROGRAM DIRECTORS IN THE SBIR OFFICE. SO THIS YEAR 11 OF THE 18 TOPICS WERE SELECTED TO MOVE FORWARD FOR REVIEW BY OF SCIENTIFIC PROGRAM LEADS. BY THE COORDINATING COMMITTEE AS HAVING MOONSHOT REL CONVENIENCE. I JUST WANT TO NOTE ADDITIONAL INFORMATION IS THERE ON EACH TOPIC IN THE ONE PAGE WRITE-UP. SO THE FIRST TOPIC FOR CONSIDERATION IS THE DEVELOPMENT OF ULTRAFAST DOSE RATE RADIATION DETECTORS AND SAFETY SYSTEMS FOR CANCER TREATMENT. AND THE GOAL OF THIS TOP SICK TO DEVELOP DEVICE THAT'S CAN DELIVER TO PATIENTS SAFELY AND EFFECTIVELY IN A CLINICAL SETTING AND WITH THIS REQUEST, WE'RE FOCUSED ON RADIATION DETECTORS THAT CAN RELIABLY FUNCTION AT DOSE RATES OF 40 TO 120 PER SECOND AND ALSO INCLUDE SAFETY SYSTEMS CAPABLE OF RECORDING DELIVERY AND SHUTTING OFF DURING SLASH THERAPY IF NEEDED. THE PREVIOUSLY FUNDED PROPOSALS WERE SUCCESSFUL AND LED TO THE DEVELOPMENT OF TECHNICALLY SUFFICIENT DETECTORS AND WE LIKE COMPANIES TO EXPAND POP THESE DETECTORS TO FULLY DEVELOP THE SAFETY SYSTEM THAT GO WITH THEM. SO THESE PRODUCTS WE SEE HAVE THE POTENTIAL TO SIGNIFICANTLY DECREASE NORMAL TISSUE TOXICITY AND THEY MIGHT DELIVER THERAPEUTIC BENEFITS TO PATIENTS AVOIDING SOME OF THE SIDE EFFECTS. SO NOW I WILL SUMMARIZE SIX POTENTIAL CONTRACT TOPICS IN THE AREA OF CLINICAL DIAGNOSTICS AND MOLECULAR ANALYSIS. AS A GOAL OF THIS TOPIC, TECHNOLOGY IS FOR DETECTING TUMOR DERIVED AND SUPPORT IN VITRO TECHNOLOGY THAT CAN ENUMERATE AND IDENTIFY CELL TYPES. CURRENTLY THERE ARE VERY FEW MARKERS AVAILABLE FOR PREDICTING METASTATIC RISK AND ACCUMULATING EVIDENCE THAT SUGGEST THAT THESE CLUSTERS MAY BE AN IMPORTANT FACTOR AND MAT METASTASIS AND ASSOCIATED WITH CO PROGRESS FOR SURVIVAL AND OVER ALL SURVIVAL OF PATIENTS. AND PHASE 1, COMPANIES WITH USE ANIMAL CANCER MODELS TO DEMONSTRATE USABILITY AND ACCURACY. MUCH WE BELIEVE THAT TECHNOLOGIES THAT COULD STATIC RISK EARLY ON THEY HAVE THE POTENTIAL TO FACILITATE PROMPT INTERVENTIONS AND PARTICULAR IMPROVE CANCER OUTCOMES. THE NEXT TOPIC, RAPID AND A FORWARD ABLE POINT OF CARE DIAGNOSTIC FOR CERVICAL CANCER CONTROL. AIMS TO DEVELOP TESTING AS AN APPROPRIATE PRICE THAT WILL ENABLE THE ESTABLISHMENT OF SELF-TESTING PROGRAMS GLOBALLY. SO THESE TECHNOLOGIES ARE CRITICAL COMPONENTS OF THE WORLD HEALTH ORGANIZATIONS CERVICAL CANCER ELIMINATION STRATEGY WHICH IS FOCUSED ON ADDRESSING HEALTH DISPARITIES AND RESOURCE SETTINGS AND FOR HPV SCREENING. AND WHILE SOME PLATFORMS HAVE BEEN DEVELOPED FOR HPV TESTING, THERE'S STILL REMAI REMAINS A NR RAPID POINT OF CARE TESTING CAPABILITIES SO IN ORDER TO FOCUS NCI RESOURCES ON TECHNOLOGIES THAT ARE FURTHER ALONG IN DEVELOPMENT, IT COULD BE MODIFIED TO MEET THESE NEEDS AND THIN COMMERCIALIZE RAPIDLY AND THIS TOPIC WILL ONLY HAVE (INAUDIBLE) TO THESE TWO PROPOSALS. THE NEXT TOPIC IS THE TRANSLATION OF NOVEL CANCER SPECIFIC AND TECHNIQUES TO MEDIATE SUCCESSFUL IMAGE GUIDED NERVE. AND THE GOAL HERE IS TO DEVELOP TECHNOLOGIES THAT ARE CAPABLE OF DETECTING VERY SMALL TUMOR CELL CLUSTERS IN HUMANS USING IMAGING. AND THIS IS A REISSUED TOPIC. AND THE FOCUS HERE ON THE REISSUE IS CLINICAL TRANSLATION AND VALIDATION AND PREVIOUS DEVELOPMENTAL SUCCESSES WITH ACTIVATE ABLE DIAGNOSE TICK APPROACH. SO PART OF THE PHASE 1 DELIVER ABLES, COMPANIES ARE REQUIRED TO VALIDATE THE SENSITIVITY AND SPECIFICITY OTHER TECHNOLOGY ANIMAL CANCER MODELS AND OBTAIN IRB APPROVAL DURING DAY TWO, COMPANIES WILL BE REQUIRED TO CONDUCT A DOSE SOH AND SAFETY STUDY FOLLOWED BY VALIDATION STUDY IN HUMANS IN THE CANCER INDICATION OR INDICATIONS. THE NEXT TOPIC IS THE DEVELOPMENT OF MICROBIOME BASED TESTS FOR CANCER RESEARCH DIAGNOSIS PROGNOSIS OR PATIENT MANAGEMENT. LAST YEAR THE MICROBIOME WAS ADD TO THE LIST OF CANCER HALLMARKS AND IN ROW SEPTE RECENT YEARS, L STUDIES HAVE REVEALED THAT ASSOCIATION OF SPECIFIC HIGH ROWE BIOME SIGNATURES WITH THEIR CANCER AS WELL AS THERAPIES. SO PRODUCTS THAT ARE DEVELOPED UNDER THIS TOPIC COULD BE ASSAYS IN THE FORMS OF KITS OR SERVICE TO DETECT MICRO BIO SIGNATURES RELATED TO CANCER AND THESE TECHNOLOGIES WOULD BE CAPABLE OF USING WITH BIOPSIES AND IT CAN BE FASTER, SAFER AND MORE COST EFFECTIVE TO OBTAIN THAN BIOPSIES AND PARTICULARLY FOR CANCERS AND TUMORS THAT ARE DIFFICULT T TO ACCESS. THE NEXT TOPIC IS THE DEVELOPMENT OF ORGAN FOR PRECLINICAL AND TRANSLATIONAL RADIOLOGICAL STUDIES. AND WITH THIS NEW TOPIC, WE WOULD LIKE COMPANIES TO BUILD UPON WORK DONE IN THE SPACE AND VALIDATE THESE DEVICES IN ANIMAL CANCEL MODELS AND THE FOCUS SHOULD BE DEVELOPING A PRODUCT THAT ENABLES RESEARCHERS IN INDUSTRY SETTINGS TO CONDUCT STUDIES WITH RADIATION ALONE AS WELL AS SINGLE COMBINATION ALONG WITH OTHERS. SO THESE PRODUCTS THAT WE FEEL COULD ACCELERATE PROGRESS IN THE RADIO THERAPY MARKET BY IMPROVING THE ABILITY TO PREDICT EFFICACY AND TOXICITY OF DRUG RADIATION COMBINATION AS WELL THE POTENTIAL TO DECREASE THE COSTS OF PRECLINICAL RESEARCH WITH THERAPEUTICS. SO LAST TOPIC UNDER CLINICAL DIAGNOSTICS AND MOL IKE LAR ANALYSIS IS POINT OF CARE DETECTION OF PROSTATE SPECIFIC ANTIGENS. AND THE GOAL HERE IS TO DEVELOP AND VALIDATE A RAPID LOW COST, USER FRIENDLY, AND EQUIPMENT FREE POINT OF CARE TEST FOR PSA THAT REQUIRES ONLY THE USE OF BLOOD VIA A FINGER STICK. CURRENT TESTS AVAILABLE AND EITHER THEY REQUIRE SAMPLES THAT NEED TO BE MAILED TO A CENTRAL LAB OR THEY ARE AT A PRICE POINT THAT IT'S NOT AFFORDABLE FOR FULL ADOPTION OR THEY PROVIDE LESS THAN IDEAL READOUTS FOR PATIENTS AS WELL. SO THE AIM HERE IS THAT PRODUCTS WILL BE DEVELOPED THAT WILL REDUCE BARRIERS TO TESTING ESPECIALLY FOR AFRICAN AMERICAN MEN WHO MAY BENEFIT FROM PSA SCREENING AND THE ADDRESS OF SIGNIFICANT CANCER HEALTH DISPARITY. NOW I'LL HIGHLIGHT FOUR TOPICS THAT WE HAVE RELATED TO INFORMATION TECHNOLOGY AND BIO INFORMATICS AND THE FIRST IS CANCER REPRESSION AND TREATMENTS -- I BELIEVE WE'RE ALLFAMILIARF RECRUITMENT FROM CERTAIN COMMUNITIES AND AREAS OF THE COUNTRY AND THIS IS WELL DOCUMENTS AND WE HOPE IT SUPPORTS PRODUCTS THAT ADDRESS THESE ISSUES AND PROMOTE THE ENGAGEMENT OF ALL PATIENTS WITH CANCER AND CLINICAL TRIALS. THE NEXT TOPIC IS CLOUD BASED MULTI MODAL SOFTWARE FOR THE CANCER RESEARCH DATA COMMONS. AND OUR COLLEAGUES IDENTIFIED UNMET CHALLENGES WITH BIG DATA APPAL SIS THAT STILL EXIST AND SO SPECIFICALLY AN AREA ANALYTICAL TOOLS THAT CAN INTEGRATE WITH MULTI MODAL DATA AND WE'VE ADD DETAILS TO THE SOLICITATION THAT HIGHLIGHTS THE GAPS AND DATA ANALYSIS AND THIS IS NOT AN AREA WHERE WE RECEIVED MANY APPLICATIONS THROUGH OUR INVESTIGATOR INITIATED OMNIBUS GRANT MECHANISMS SO FUNDING THROUGH THIS TOPIC IS IMPORTANT TONE ABLE THE CRDC RESOURCE AND BE LEVERAGED BY THE CANCER RESEARCH COMMUNITY. NEXT SLIDE, PLEASE. CAN YOU ABOUT BACK ONE SLIDE, PLEASE? THE NEXT IS EVALUATION DATASETS AS MEDICAL DEVELOPMENT TOOLS FOR TESTING CANCER TECHNOLOGIES AND THE GOAL HERE IS TO DEVELOP DATASETS THAT CAN BE USED TO ASSESS MEDICAL DEVICES AND ONCOLOGY SETTINGS. AND I JUST WANT TO HIGHLIGHT HERE THAT THIS TOPIC WAS DEVELOPED IN COLLABORATION WITH COLLEAGUES AT THE FDA AND HAS THE ADDITIONAL GOAL OF SIMULATING PATIENTS OF SMALL BUSINESSES AND THE FKA'S MEDICAL DEVICE DEVELOPMENT TOOL PROGRAM. THIS PROGRAM IS A MECHANISM THAT FDA OTHERS TO QUALIFY TOOLS THAT CAN FACILITATE THE REGULATORY DECISION-MAKING WHEN EVALUATING A MEDICAL DEVICE. THIS PROGRAM WE BELIEVE BENEFITS NCI FUNDED COMPANIES BECAUSE THESE FDA QUALIFIED TOOLS WITH TO OTHER ENTREPRENEURS WHO ARE DEVELOPING NEW TECHNOLOGIES AND OR USED TO EVALUATE THEIR EXISTING TECHNOLOGIES AND THE TOTAL PRODUCT LIFE CYCLE AND THIS REALLY PROVIDES A REVENUE STREAM FOR THIS SMALL BUSINESS THAT ORIGINALLY DEVELOPED THE TOOLS. IN ADDITION, OTHER COMPANIES AND THIS INCLUDES OTHER NCI FUNDED SMALL BUSINESSES THAT USE THE TOOL, TO EVALUATE THEIR NEW TECHNOLOGIES ARE ABLE TO SPEED UP THE FDA REGULATORY REVIEW PROCESS AND POTENTIALLY SHORTEN THEIR OVER ALL DEVICE DEVELOPMENT TIMES. AND THIS IS A REISSUE TOPIC AND WE RECEIVED PROPOSALS PREVIOUSLY BUT WE DID NOT FUND THEM BECAUSE THEY WEREN'T WHAT WE WERE LOOKING FOR. SO WE'VE ADDED DETAILS AND EXAMPLES OF PRODUCTS TO THE REISSUE SOLICITATION THAT WILL FACILITATE MORE RESPONSIVE PROPOSALS AND WE THINK THIS IS AN IMPORTANT AREA FOR NIH TO FUND BECAUSE IT'S A SIGNIFICANT NEED WE SEE IN THE ONCOLOGY MEDICAL DEVICE COMMUNITY AS WELL AS THE GAP CURRENTLY IN OUR PORTFOLIO. THE LAST TOPIC FOR YOUR CONSIDERATION IS AUTOMATED SOFTWARE FOR POINT OF CARE TESTING TO IDENTIFY CANCER ASSOCIATED NON NUTRITION. AND THE GOAL HERE IS TO DEVELOP A NUTRITION SCREENERS THAT CAN DEPICT MALNUTRITION EARLY ON AS WELL AS CANCER CARE PARTICULARLY IN CANCER POPULATIONS WITH HIGHER PREVALENCE OF NON NUTRITION. AND NUTRITION RISK. THIS CONTRACT TOPIC WILL SUPPORT PRODUCT DEVELOPMENT THAT UTILIZES EITHER EXISTING NUTRITION SCREENERS AS WELL AS COUPLING THIS WITH SEGMENTATION WITH DIAGNOSTIC IMAGING FROM CT AND MRI. NEXT SLIDE, PLEASE. SO I WOULD JUST LIKE TO END TODAY BY EMPHASIZING THE SIBR CONTRACT MECHANISM HAS SUPPORTED THE SUCCESSFUL COMMERCIALIZATION OF MANY PRODUCTS THAT ARE USED FOR DIAGNOSING OR TREATING PATIENTS WITH CANCER AND HERE IS A SAMPLE, A SIDE PRODUCT FROM ACROSS DIFFERENT TECHNOLOGIES AREAS AND FROM 2013 TO 2018 WE FOUND THAT 20% OF FUNDED PROJECTS HAVE RESULTED ALREADY AND COMMERCIALIZED PRODUCTS. AND WHEN WE LOOK THE THE EARLIER YEARS, WHEN WE GOT TO 2013 THIS INCREASES TO JUST OVER 30% OF CONTRACT FUNDED PROJECTS THAT HAVE RESULTED IN COMMERCIALIZED PROJECTS. AND THIS WAS SIMILAR TO WHAT WE HAVE SEEN IN OUR GRANTS PORTFOLIO. SO, YOU KNOW, WE CONSIDER CONTRACTS TO BE A VERY IMPORTANT MECHANISM AND FOR NCI FUNDING AND IT'S A WAY THAT WE CAN REALLY SUPPORT INNOVATIVE PRODUCTS, GETTING TO THE CLIP I CANCLINICFOR PATIENTS WITH CANC. THANK YOU FOR YOUR TIME AND I'M HAPPY TO TAKE ANY QUESTIONS TODAY. >> Dr. Flaherty: THANK YOU, VERY MUCH. KAREN. >> THANK YOU, Dr. POND FOR SUCH A THOUGHTFUL PRESENTATION. YOU KNOW, I WAS CHAIRING THIS REVIEW PANEL ALONG WITH Dr. FLAHERTY AND WE HAD NOTHING BUT ENTHUSIASM FOR THE SBIR PROCESS AND WE VERY MUCH APPRECIATED THE WE WANT IT CARRIED FORWARD FROM THE NCI. OUR QUESTIONS ARE WITH Dr. POND AT OUR FIRST MEETING AROUNDS TWO YEARS, ONE IS ON PROCESS. SO HOW DOES THE DECISIONS THAT WERE MADE CIRCLE THE TOPIC AREAS? WHAT MADE IT THROUGH THAT FILTER AND WHAT WAS LEFT ON THE CUTTING ROOM FLOOR, IF YOU WILL AND TRYING TO UNDERSTAND HOW THOSE PRIORITIES WERE MADE SO WE HAD A GOOD DISCUSSION ABOUT THE THINGS THAT WERE REFLECTED NOW IN THIS MODIFIED PRESENTATION, YOU KNOW, WHAT OTHER AGENCIES WERE INVOLVED AND HOW THE CALLS WERE PREPARED AND HOW THE GROUP VIEWS PREDICTING THE NUMBER OF AWARDS AND A CERTAIN AREA THAT MAY COME TO PASS SO YOU REALLY FELT VERY COMFORTABLE WITH THOSE ANSWERS AND SECOND AREA THAT WE FOCUSED ON WAS HOW THIS RELATES TO SIMILAR TYPES OF MECHANISMS AS SBIR-LIKE MECHANISMS ACROSS THE NIH AND WAS THERE COR DIN SITUATION AND WHAT WE CAME TO LEARN WERE SOME OF THE DIS FINK, YES, THERE IS. EX ALSO TO LEARN ABOUT THE NCI VERSION OF THE SBIR PROGRAM WHICH YOU HEARD ABOUT. SO I THINK THERE WAS WIDESPREAD ENTHUSIASM FOR THIS CONCEPT AND I WILL TURN IT OVER TO Dr. FLAHERTY TO SEE IF I'VE BEEN COMPREHENSIVE IN MY REVIEW. >> Dr. Flaherty: THANK YOU, KAREN. DAVID. >> SO I THINK OVER THE YEARS I'VE HAD THE OPPORTUNITY TO REVEAL ALMOST ALL ASPECT APPROXIMATES OF THE SBIR PROGRAM AND I'M VERY CLEAR THAT IT PRODUCES A TREMENDOUS AMOUNT OF INNOVATION OVER ALL AND I THINK THE QUESTIONS RELATED HERE AS YOU SAID WERE MORE TO THE ISSUE OF WHAT IS THE CONTRACT MECHANISM OF WHAT GAP IT FILLS AND I FEEL CONVINCED THAT THE PROCESS WAS BOTH COMPREHENSIVE AND IMPORTANT IN TERMS OF HOW TOPICS WERE SELECTED. AND I FOCUSED ON THE DELIVERABLES BECAUSE IT'S IMPORTANT TO SEE EXACTLY WHAT HAPPENED WITH CONTRACTS VERSUS THE COMPETITIVE PROGRAM AND THE WIDESPREAD COMPETITIVE PROGRAM AND THAT DELIVERABLES ON BOTH SIDES ARE ACTUALLY QUITE IMPRESSIVE. REACHING 30% COMMERCIALIZATION IS I AM PROSE I HAVE AND SO I'M SUPPORTING AND CONTINUING IT. >> THIS IS THE MOST COMPLEX PORTFOLIO ANALYSIS THAT IS TAKEN WHICH IS WHERE WE CENTERED MUCH OF OUR CONVERSATIONS. IT CAME AWAY COMFORTABLE THAT VERY IMPRESSIVE REPERTOIRE FOR A DEEP DIVE ANNAL IS SIS OF WHAT ELSE THE NCI IS SUPPORTING. ANY A FURTHER DISCUSSION? I CAN'T HEAR YOU. >> WE LOST YOU AGAIN. >> SO THIS IS EXCITE TO GO SEE AND I JUST CUT TO THE CHASE. -- >> CAN YOU GET CLOSER TO THE MIC. >> I AM CLOSE. LET ME SEE. IS THERE SOMEONE ELSE WHO WANTS TO SAY -- >> NO. JUST GET A LITTLE BIT CLOSER AND WE CAN HEAR YOU. >> IS THIS GOOD? >> IT'S EXCITING. COMPREHENSIVE EX COMPLEX. A COUPLE OF QUESTIONS AND ONE IS LOOKING AT THE PORTFOLIO AND LOOKING INTO THE FUTURE A POINT OF CARE TESTING IS GREAT BUT WHAT ABOUT HOME TESTING TECHNOLOGIES IF THERE'S IN THE CARDS IN THE FUTURE AND THE SECOND QUESTION I HAVE IS WHAT IS THE PLAN AND THIS CAME BEFORE US IN THE PAST SO INCREASE DIVERSITY OF VENDORS AND THAT CONTRACTORS AND IN THE PROCESS THAT DO YOU GET VENDORS AND LET ME SAVE THAT WORD, CONTRACTORS OR AWARDS TO PROVIDE THAT DIVERSITY AND I THINK WE WANT TO SEE IN MANY OF THESE CONDITIONS THAT EFFECT POPULATIONS DISPROPORTIONATELY. SO TWO QUESTIONS. I'LL ADDRESS YOUR DIVERSITY QUESTION FIRST. THE QUESTION FIRST QUESTION, I COULDN'T HEAR WHICH CONTRACT TOPIC YOU ARE REFERRING TO YOU SAID INSTEAD OF POINT OF CARE, WHAT ABOUT HOME DEVICES? AND. >> THAT WAS MORE RATHER THAN TO ME QUESTION BECAUSE IF WE CAN DO A SELF TESTING AT HOME, SELF-SAMPLING AT HOME AND THE PRACTICE OF TEST IS A GOOD EXAMPLE. CAN'T WE DO THE SELF-TESTING PERHAPS IN THE FUTURE. >> TO SUGGEST YOUR QUESTION DIVERSITY IS AN IMPORTANT PART OF THE SBIR MISSION AND OUR GOALS AND ONE OF THE CONTRACT TOPICS I JUST PRESENTED, THE ONE ABOUT TOOL DEVELOPMENT FOR RECRUITMENT AND RETENTION OF DIVERSE POPULATIONS AND THIS HIGHLIGHTS ONE OF THE REAL BENEFITS OF USING A CONTRACT MECHANISM BECAUSE WE'RE ABLE TO SPECIFICALLY REQUIRE THE PRODUCT BE TESTED AND VALIDATED WITH DIVERSE POPULATIONS. AND SO THAT IS SOMETHING WE APPRECIATE FOR THE CONTACT MECHANISM AND WE FEEL IT BRINGS REAL VALUE. THE SECOND POINT IS, YOU KNOW, OUTSIDE OF CONTRACTS AND WITH OUR WHOLE PORTFOLIO, DIVERSITY OF ENTREPRENEURSHIP IS A FOCUS AND WE HAVE LAUNCHED WHAT WE CALL OUR AAP, OUR APPLICANT ASSISTANT PROGRAM AND IN 2019, IT WAS THE FIRST OF ITS KIND AT NIH AND THIS WAS A FREE 10-WEEK PROGRAM TO PEOPLE WHO WERE NEW TO ENTREPRENEURSHIP TO RECEIVE MENTORING AND TRAINING AND PUTTING TOGETHER THE APPLICATIONS AND OUT OF THIS PROGRAM, WE'VE HAD NINE COHORTS THAT HAVE GONE THROUGH THIS PROGRAM AND IT'S EXPAND TODAY 10 WHICH WE MANAGE ON BEHALF OF ALL 10 AND WE FOUND THAT OF THIS 55 OUT OF THE 63 AWARDS THAT COME HAVE OUT OF THAT PROGRAM HAVE BEEN TO UNDER REPRESEN REPRESEND POPULATIONS SO THIS IS WOMEN AND INDIVIDUALS FROM RACIAL AND NICK GROUPS THAT ARE UNDER REPRESENTED AS WELL AS COMPANIES LOCATED IN NIDS SPACE. ON HPV, YOU KNOW, THAT IS A GEE GOOD QUESTION AND I WILL TURN IT OVER TO MY COLLEAGUE WHO IS INVOLVED IN A FEW MORE OF THE DETAILS OF THIS TOPIC. >> GREAT QUESTION, I WORKED WITH THE TEAM FROM DIVISION OF CANCER PREVENTION ON THIS TOPIC AND FROM WHAT I UNDERSTAND, THE TOPIC WE'RE LOOKING FOR TECHNOLOGIES THAT ARE THE POINT OF CARE DELIVERY BECAUSE THERE'S OPPORTUNITIES TO DO RAPID TESTING AND PROVIDE TREATMENT TO WOMEN IN NEED SO IT COULD BE A APARTMENTED FOR HOME USE UNDER THE RIGHT SITUATION BUT WE'RE NOT LOOKING FOR THAT. >> THANK YOU. >> Dr. Flaherty: SEEING NO OTHER HANDS. WE CAN MOVE TO VOTING. KAREN, WOULD YOU LIKE TO MAKE A MOTION. >> I WOULD. I'D LIKE TO MAKE A MOTION TO APPROVE. >> Dr. Flaherty: GREAT. I WILL NOT BE THE SECONDER SINCE I'M CHAIRING AND DAVID, WOULD YOU LIKE TO SECOND THAT. >> SECOND. >> THANK YOU. >> Dr. Flaherty: ANY FURTHER DISCUSSION? SO WITH MOTION TO APPROVE, LOOKING FOR ANY DISAPPROVAL VOTES. VOICE OR RAISE OF HAND. ANY A ABSTENTIONS. I DON'T HAVE ANY RECORDED IN ADVANCE. >> IT'S UNANIMOUS APPROVAL. >> Dr. Flaherty: EXCELLENT. WE REACHED THE END OF OUR BRIEF REVIEW AND I HOPE TO SEE MORE PROPOSALS IN THE JUNE MEETING AS I SAID BEFORE. THANK YOU ALL FOR EXCELLENT DISCUSSION BOTH IN THE CONCEPTS AND PRIOR TO THAT TIME. WE ARE OVER TIME AND OUR AGENDA AND THE ONLY OTHER AGENDA ITEM IS ALWAYS WE USUALLY FINISH WITH ANY NEW BUSINESS PRESSING ISSUES FOR TODAY'S DISCUSSION AND AS WELL AS CONSIDERATIONS FOR FUTURE TOPICS TO DISCUSS AND FUTURE MEETINGS. I'LL SUGGEST THAT FOR THE FUTURE MEETINGS PLEASE REACH OUT TO ME DIRECTLY AND PAULETTE AND WE WILL ACCUMULATE SUGGESTIONS IN TERMS OF FUTURE TOPICS TO ASK NCI LEADERSHIP TO LIBERATOR ON WITH US AND ANY OTHER PRESSING ISSUES FOR TODAY? >> LOOK FORWARD TO JUNE. >> Dr. Flaherty: YES, IN-PERSON IN JUNE. ALL RIGHT. EXCELLENT. THANK YOU, ALL. APPRECIATE THE PARTICIPATION. >> THANK YOU. >> THANK YOU, EVERYONE. >> BYE.