WE WOULD LIKE TO WELCOME THE MEMBERS OF BOTH THE BOARD OF SCIENTIFIC ADVISORS AND NATIONAL CANCER ADVISORY BOARD, THE EX OFFICIO MEMBERS, STAFF AND GUESTS. MEMBERS OF THE PUBLIC WHO MAY WISH TO EXPRESS VIEWS REGARDING ANY ITEMS DISCUSSED DURING THIS MEETING MAY DO SO BY WRITING DR. PAULETTE GRAY, EXECUTIVE SECRETARY OF THE BOARD, WITHIN TEN DAYS AFTER THE MEETING. ANY WRITTEN STATEMENTS OR QUESTIONS SUBMITTED BY MEMBERS OF THE PUBLIC WILL RECEIVE CAREFUL CONSIDERATION. AS BOARD MEMBERS, I WANT TO REMIND YOU YOU MUST ABSENT YOURSELF VIRTUALLY DURING SPECIFIC DISCUSSIONS WHEN YOUR PARTICIPATION AND DELIBERATIONS ON A PARTICULAR PRODUCT, PROGRAM, OR OTHER SPECIFIC MATTER WOULD CONSTITUTE CONFLICT OF INTEREST OR CREATE THE APPEARANCE OF ONE. IT IS INCUMBENT UPON YOU TO ADVISE EXECUTIVE SECRETARY AND ABSTAIN REGARDING THAT MATTER. IN LIGHT OF THE CURRENT POLICIES GOVERNING CONFLICT OF INTEREST BASED ON FINANCIAL HOLDINGS OF SPECIAL GOVERNMENT EMPLOYEES INCLUDING ALL MEMBERS OF BOTH BOARDS WE MUST DEPEND ON YOU TO VOLUNTARY ABSENT YOURSELF DURING ANY AND ALL DISCUSSIONS OF MATTERS THAT COULD IMPACT STATUS OF THOSE HOLDINGS. WE TRUST YOUR JUDGMENT IN THESE INSTANCES. ANY MATERIALS OR DISCUSSIONS OF A CONFIDENTIAL NATURE DELIBERATED ON IN CLOSED SESSION ARE PRIVILEGED INFORMATION MADE AVAILABLE ON A NEED TO KNOW BASIS. SUCH DELIBERATIONS ARE PRIVATE AND CONTENTS SHOULD NOT BE DIVULGED. FUTURE MEETING DATES ARE PROVIDED TO YOU AND ARE LISTED ON THE AGENDA. APPROVE FEBRUARY 11, 2020 VIRTUAL MEETING SUMMARY MINUTES MUST BE DONE AT THIS TIME, SO I WOULD LIKE ALL NCIB MEMBERS TO VOTE, EITHER YAY, NAY, OR TO ABSENT. CAN I GET A MOTION TO ACCEPT? >>> SO MOVED. >> SECOND? >> SECOND. >> ANY DISCUSSION? ALL THOSE IN FAVOR PLEASE SAY AYE OR RAISE YOUR HAND. >> AYE. >> AYE. >> ANYONE NOT APPROVING? ANYONE ABSTAINING? OKAY. MINUTES ARE APPROVED. WE WOULD LIKE TO APPROVE THE BSA 2020 MAY 12 VIRTUAL MEETING SUMMARY MINUTES. I NEED AGAIN ONLY THE BSA MEMBERS. DO I HAVE SOMEONE TO MOTION APPROVAL? >> SO MOVED. >> SECOND? >> SECOND. >> SECOND. >> ANY OTHER DISCUSSION BEFORE WE MOVE FORWARD? ALL THOSE IN FAVOR SAY YAY. >> YAY. >> YAY. >> ANY NAY? ANYONE WANT TO ABSENT? SO APPROVED. THANK YOU ALL. I NEED TO MAKE SURE WE HAVE A QUORUM. >> LIZ, WE HAVE (INDISCERNIBLE). >> SORRY, I DIDN'T SEE THAT ON THE LIST. I NEED TO APPROVE APRIL 92020 BSA/NCAB MEETING MINUTES. THANK YOU, PAULETTE. I DID MISS THAT. VIRTUAL MEETING SUMMARY MINUTES. I NEED SOMEONE TO MOTION APPROVAL. >> SO MOVED. >> SECOND? >> SECOND. >> ANY DISCUSSION? IN FAVOR SAY YAY. >> YAY. >> YAY. >> YAY. >> ANY NAYS? ANYONE WANT WANT TO ABSENT? THANK YOU VERY MUCH. MOVING TO THE QUORUM, BY LAW A QUORUM OF BOARD MEMBERS IS REQUIRED FOR EACH INSTANCE WHICH VOTE MAY OCCUR, OPEN OR CLOSED SESSION, A MINIMUM OF 23 APPOINTED MEMBERS MUST BE PRESENT TO VOICE VOTES. YOUR PRESENCE IN THE VIRTUAL ROOM FOR ALL SEGMENTS IS A MUST. WHEN WE DO CONCEPTS LATER TODAY, BOTH BOARDS CAN PARTICIPATES IN DISCUSSION ONLY BSA MEMBERS WILL BE COUNTED IN THE VOTE. THE QUORUM AT THAT TIME WILL BE 15 MEMBERS. AND TO ENSURE NO INTERRUPTIONS DURING TODAY'S MEETING, PLEASE ENSURE THAT YOU ARE MUTE AND REMAIN SO UNTIL YOU'RE RECOGNIZED BY MYSELF, EXECUTIVE SECRETARY, NCI DIRECTOR OR SPEAKER AT THAT TIME. IF THERE'S NO CONCERNS OR QUESTIONS WE'LL NOW BEGIN WITH TODAY'S AGENDA, AND THE NCI DIRECTOR'S REPORT. NED? >> GOOD MORNING, ESPECIALLY THOSE ON THE WEST COAST UP EARLY TO JOIN US. THANK YOU FOR JOINING US VIRTUALLY. WE HAVE A LONG AGENDA, FULL AGENDA AHEAD SO I'LL GET INTO IT TO MAKE MY REMARKS BRIEF. WE'RE DELIGHTED TO WELCOME FOUR NEW FULL MEMBERS TODAY, I INTRODUCED THESE NEW MEMBERS LAST TIME WHEN THEY WERE ATTENDING AS NCAB GUESTS. DR. ANNA BARKER, DR. HOWARD FINGER, WITH A LONG EXPERIENCE ADVISING THE NCI AND FDA. DR. ANDREA HAZE JORDAN, SURGEON IN CHIEF, UNIVERSITY OF NORTH CAROLINA CHILDREN'S HOSPITAL, AND DR. SUSAN VATTA, VICE CHAIR, MOFFITT CANCER CENTER. I HAVE SLIDES TOO IF WE COULD BRING THOSE UP. LATELY EACH TIME WE MEET OUR CIRCUMSTANCES HAVE CHANGED IN WAYS WE DID NOT FORESEE. IN EARLY APRIL, WE HELD A MEETING TO FOCUS ON PANDEMIC AND NCI RESPONSE. AT THAT TIME NCI AND MANY INSTITUTIONS MOVED TO TELEWORK ENVIRONMENT FOR COVID-19 RELATED CARE AND RESEARCH, THREE TO FOUR WEEKS IN AT THAT TIME. CONVENING A MEETING VIRTUALLY ENTIRELY WAS STILL NEW, AND THE CANCER RESEARCH COMMUNITY WAS REELING WITH LIMITED EVIDENCE, MANY REMEMBER THE GLIMPSE INTO THE PANDEMIC EPICENTER AT NYU. I REFLECTED ON A QUOTE FROM HAMLET THAT I LIKE, WHEN SORROWS COME, THEY COME NOT AS SINGLE SPIES BUT BATTALIONS. SADLY THAT SENTIMENT IS STILL WITH US TODAY. MAY 12 BSA GATHERED FOR A MARATHON MEETING, REVIEWING 13 CONCEPTS. I FOR ONE FOUND IT REASSURING TO FOCUS ON BREAD AND BUTTER CANCER RESEARCH, IDENTIFYING AND INCENTIVIZING THIS GREAT CANCER RESEARCH THAT'S THE BUSINESS OF NCI. AND TODAY FOUR WEEKS LATER IT SEEMS EVERYTHING ONCE AGAIN HAS BEEN SCRAMBLED AND CHANGED. THE NEWS IS NOW FILLED WITH IMAGES SHOCKING AND UNFORGETTABLE BUT ALSO DEFY EXPLANATION, NO LONGER CROWD OF E.R.s AND ICUS AND AMBULANCES BUT INSTEAD POLICE BRUTALITY MARCHES AND PROTESTS. WE EACH WRESTLE WITH THE STARK REALITIES OF RACIAL INJUSTICE WE HAVE TO CONFRONT ISSUES AS A PROFESSION, AS PEOPLE WHO DEVOTED CAREERS TO ALLEVIATING I'M GRATEFUL FOR OUR LEADERS SPEAKING OUT, SOMETHING IN PARTICULAR I ADMIRED WERE TWO PIECES IN THE RECENT JUNE 5 CANCER LETTER FROM ROB WYNN, VCU, AND OTIS BRAWLEY, WITH US TODAY. I HIGHLY RECOMMEND THEM. OTIS, THANK YOU FOR YOUR COMMENTS AND LIFETIME OF LEADERSHIP. I ANTICIPATES IN FUTURE BOARD MEETINGS WE'LL SEEK COUNCIL ON HOW NCI CAN ENHANCE CURRENT PROGRAMS TO ADDRESS CANCER DISPARITIES AND WORKFORCE DIVERSITY. WE ALSO HAVE SOME NEW THINGS IN THE WORKS THAT WE'LL WANT TO DISCUSS WHEN THEY ARE READY FOR TALKING ABOUT. IN THE MEANTIME WE'RE HERE TO LISTEN. NEXT SLIDE PLEASE. USUAL BUSINESS, A TRADITIONAL SLIDE I ALWAYS SHOW WHERE WE ARE IN THE BUDGETING PROCESS. OBVIOUSLY THIS YEAR'S APPROPRIATION PROCESS IS QUITE STRANGE AND DIFFERENT FROM PRIOR YEARS. CONGRESS IN ADDITION TO WORKING ON THE 2021 BUDGET IS ALSO HARD AT WORK STILL ON A FIFTH SUPPLEMENT TO THE 2020 BUDGET, THERE'S A LOT IN PLAY ON THIS TOPIC, IT'S COMPLICATED AND I'LL LEAVE THIS TO M.K. HOLOHAN TO TALK ABOUT LATER ON THIS MORNING, VERY INTERESTING, A LOT GOING ON. NEXT SLIDE PLEASE. OUR PRIMARY CONCERN IS OF COURSE THE HEALTH AND SAFETY OF PEOPLE WITH CANCER, HEALTH CARE PROVIDERS, AND NCI GRANTEES AND STAFF. AND WE'RE FORTUNATE AND PROUD TO BE ABLE TO CONTINUE TO CONTRIBUTE OUR EXPERTISE AND INFRASTRUCTURE TO THE CRITICAL RESEARCH ON COVID-19 SEPARATE. HERE ARE A LIST OF SOME ACTIVITIES AS WELL AS LINK AT THE BOTTOM TO PROVIDE FURTHER INFORMATION ON THESE ITEMS, WE'VE DISCUSSED A LOT OF THIS AT PRIOR MEETINGS, I WON'T GO INTO DETAIL, AND DOUG WILL TALK ABOUT SEROLOGY MORE. I'LL HIGHLIGHT ON THE CLINICAL TRIALS OF IMMUNOMODULATORY AGENTS, NEW TRIAL THAT'S OPEN FOR TOCILIZUMAB AND AND ACALABRUTINIB. AND EVEN THOUGH WE'VE HAD RECENT PRESENTATIONS, I'LL UPDATE YOU BRIEFLY. NEXT SLIDE PLEASE. AS YOU ARE AWARE, CONGRESS HAS PROVIDED NATIONAL CANCER INSTITUTE WITH A LARGE SUPPLEMENTAL APPROPRIATION FOR RESEARCH OF COVID-19 SEROLOGY AND RELATED TECHNOLOGIES. THE HISTORY OF THIS IS EARLY MARCH DURING EARLY DAYS OF THE PANDEMIC RESPONSE WE PIVOTED TOP NOTCH SEROLOGY LAB AT FREDERICK NATIONAL LAB WHICH DOES REGULATORY GRADE WORK FOR HPV AND MOVED THAT LAB TO WORK ON CORONAVIRUS, COLLECTED SAMPLES, REAGENTS, WORKING WITH CDC AND NIAID DEVELOPED AN ELISA RESPONSE, MANY HELPING WITH SAMPLES. WE WERE APPROACHED BY DEVICE CENTER AT FDA FOR HELP WITH PERFORMANCE TESTING LEADING TO EXCITING AND GRATIFYING INTERAGENCY COLLABORATION TO TEST USABILITY IN REAL WORLD SETTINGS. SEROLOGY WORK AT FREDERICK AND OTHER PARTS OF THE NCI CONTINUES TODAY AT FURIOUS PACE WITH COLLABORATORS AT FDA, CDC, BARDA AND NIAID, AND DOUG WILL TALK MORE ABOUT THIS LATER. NEXT SLIDE. I SHOULD MENTION REGARDING SEROLOGY THE MAY MEETING DINAH SINGER SHARED PLANS FOR SEROLOGIC SCIENCE NETWORK, HATS OFF TO THE TEAM FOR MOBILIZING STAFF TO CRAFT THIS PROGRAM. WE RECENTLY PUBLISHED TWO FUNDING ANNOUNCEMENTS TO MEET URGENT NEED ASSOCIATED WITH PANDEMIC, OPEN RFAs DEVELOPED IN RECORD TIME, CLOSE ON JULY 22. EXPERTISE IN THESE AREAS IS WELL BEYOND RESEARCHERS USUALLY AT NCI POOL, WE'RE REACHING OUT THROUGH NON-TRADITIONAL CHANNELERS. I EXPLAINED HOW THE NETWORK IS NOT SOLELY CANCER FOCUSED, WE HOPE AND EXPECT MANY BASIC SCIENCE INQUIRIES REPORTED BY THE NETWORK, FOR EXAMPLE, LINKS BETWEEN IMMUNITY OR ANTIBODY STRUCTURE AND FUNCTION, WE HOPE AN EXPECT THESE STUDIES WILL BE HIGHLY VALUABLE TO CANCER RESEARCH AS WELL. NEXT SLIDE PLEASE. I'M SORRY. OOPS. GO BACK PLEASE. THANK YOU. JIM DOROSHOW SHARED PLANS FOR THIS STUDY IN APRIL. THIS IS OUR CLINICAL TRIAL STUDYING COVID-19 NATURAL HISTORY IN CANCER PATIENTS. THINGS ON THIS FRONT PROGRESSED MARVELOUSLY. THIS IS NOT A REGISTRY BUT TRIAL WITH INFORMED CONSEN ALLOWING LONGITUDINAL COLLECTION OF SAMPLES AND DATA FROM PATIENTS INCLUDING IMAGING RESULTS. THERE ALREADY ROBUST ANALYSIS OF SERUM BIOMARKERS TO IDENTIFY PREDICTOR OF OUTCOMES AND GERMLINE, NCCAPS HAS PLANS TO ENROLL 10,000 PATIENTS. IN MAY I SPOKE ABOUT THE IMPACT OF THE PANDEMIC ON CANCER OUTCOMES, SOMETHING MANY OF US ARE BECOMING MORE CONCERNED ABOUT. WE'VE SEEN DECADES OF GREAT PROGRESS WITH REGARD TO NATIONAL CANCER MORTALITY STATISTICS, AND NO ONE WANTS TO SEE THAT PROGRESS UNDERMINED. THIS SLIDE SHOWS WHAT WE SHOULD BE WORRIED ABOUT, WAYS THE GLOBAL PANDEMIC COULD DISRUPT CANCER PROGRESS. THERE'S THE ISSUE OF DELAYED DIAGNOSIS, PATIENTS ARE LESS LIKELY TO SEE DOCTORS FOR NEW SYMPTOM OR ROUTINE SCREENING DURING THE PANDEMIC. THERE'S THE ISSUE OF DEFERRED CARE BECAUSE HOSPITALS AND CLINICS STOPPED CERTAIN QUOTE/UNQUOTE ELECTIVE PROCEDURES, ELECTIVE LIKE RESECTION OF TUMORS AND ELECTIVE CHEMOTHERAPY. AND THEY STOPPED ELECTIVE PROCEDURES TO PRESERVE HOSPITAL CAPACITY DURING THE PANDEMIC. THERE'S THE ISSUE OF REDUCED NON-STANDARD CARE DURING THE PANDEMIC. FOR EXAMPLE, SOME CENTERS HAVE BEEN USING NEOADJUVANT THERAPIES TO DELAY SURGERY FOR SOME DIAGNOSED CANCERS, NOT A STANDARD PRACTICE NECESSARILY IN THOSE DISEASES, UNCLEAR HOW REGIMENS WILL AFFECT OUTCOME. TO BE CLEAR WE THINK HOSPITAL CLOSURES AND PAUSES WERE APPROPRIATE AT THE TIME BUT WE'RE ALSO NOW VERY MUCH INTERESTED IN UNDERSTANDING HOW WE GET OUR PATIENTS BACK IN THE CLINIC AND GET CARE RESUMED FOR THEIR BENEFIT. TO GET AN IDEA OF AN ESTIMATE OF WHAT WE THINK THE IMPACT OF THE CHANGES WILL BE I ASKED ROCKY FOYER AT NCI SIS-NET TO HELP FIGURE THIS OUT. YOU'RE FAMILIAR WITH THE NETWORK. I ASKED THEM TO TRY AND UNDERSTAND EFFECTS OF DELAYED AND INFERRED CARE ON CANCER OUTCOMES. WE CHOSE TO DO THIS FOR BREAST AND COLON CANCER, SHOWN HERE, SINCE THESE ARE COMMON CANCERS, RELATIVELY HIGH SCREENING RATES. INVESTIGATORS DEVELOPED SOPHISTICATED AND VALIDATED SIMULATION MODELS THAT PROVIDED A LINK BETWEEN COMPLEX EVIDENCE AND ACTIONABLE PUBLIC HEALTH STRATEGIES. WE MADE REASONABLE ASSUMPTIONS AND MODELED EFFECTS ON MORTALITY OVER THE NEXT DECADE. THIS ANALYSIS IS SHOWN WITH EXCESS MORTALITY PLOTTED BY YEAR, WE'LL SEE ROUGHLY 10,000 EXCESS BREAST AND COLORECTAL CANCER DEATHS OVER THE NEXT TEN YEARS, WHICH REPRESENTS ROUGHLY 1% EXCESS IN DEATHS FROM THE TUMOR TYPES OVER THAT PERIOD. FOR BOTH THESE CANCER TYPES WE BELIEVE THE PANDEMIC WILL INFLUENCE CANCER DEATHS FOR A DECADE. I FIND THIS WORRY SOME, EVEN 1% INCREASE IS A LOT OF SUFFERING, AND THIS IS CONSERVATIVE. WE DO NOT CONSIDER CANCERS OTHER THAN THOSE OF BREAST AND COLON BUT THERE'S EVERY REASON TO BELIEVE THE PANDEMIC WILL AFFECT OTHER TYPES TOO. WE DID NOT ACCOUNT FOR NON-LETHAL MORBIDITY FROM UPSTAGING, THIS ASSUMES ONLY A MODERATE DISRUPTION IN SCREENING AND CARE THAT COMPLETELY RESOLVES AFTER SIX MONTHS. OBVIOUSLY, IF THE PANDEMIC DISRUPTS ROUTINE CANCER CARE TO GREATER DEGREE OR LONGER PERIOD EFFECT COULD BE WORSE. THIS ANALYSIS BEGINS TO HELP US UNDERSTAND COSTS WITH REGARD TO CANCER OUTCOMES OF THE PANDEMIC. LET'S ALL DEGREE WE'LL DO EVERYTHING IN OUR POWER TO MINIMIZE THESE ADVERSE EFFECTS TO PROTECT OUR PATIENTS FROM CANCER SUFFERING. NEXT SLIDE. I'D LIKE TO SHOW SOME SCIENCE FROM THE INTRAMURAL PROGRAM. THIS IS A REALLY HANDSOME PAPER FROM CCR, PUBLISHED LAST WEEK IN "CELL." , STUDYING BIOMARKERS FOR LIVER CANCER, THE LARGEST STUDY TO DATE USING HIGH-THROUGHPUT IN PATIENTS WITH HEPATOCARCINOMA. VIRAL EXPOSURE SIGNATURES HOLD PROMISE FOR BEING DEVELOPED AS CANCER BIOMARKERS FOR EARLY ONSET OF HEPATOCELLULAR CARCINOMA, TESTING ON 173 PEOPLE WITH CHRONIC LIVER DISEASE. THE SIGNATURE CORRECTLY IDENTIFIED THOSE WHO DEVELOPED HCC WITH AREA UNDER CURVE .98, ALSO WHEN USING BLOOD SAMPLE IT IS HE BEGINNING, TEN YEARS BEFORE DIAGNOSIS, PROMISING DEVELOPMENTS FOR CANCER WHERE THERE'S NOT BEEN A LOT OF GOOD NEWS, OF GROWING IMPORTANCE IN THE UNITED STATES AND INTERNATIONALLY. NEXT SLIDE. HERE'S ANOTHER EFFORT OF SOMETHING WE'RE JUST GETTING STARTED WITH WE'VE BEEN WORKING ON A LONG TIME, AND TO ADDRESS ANOTHER VERY DIFFICULT G.I. MALIGNANCY, PANCREATIC CANCER WHERE THERE'S NOT BEEN SUFFICIENT PROGRESS. NEW ONSET DIABETICS OVER AT 50 ARE AT HIGHER RISK OF BEING DIAGNOSED WITH PANCREATIC CANCER WITHIN THREE YEARS OF DIAGNOSIS WITH A NEW STUDY TO EXAMINE THIS HIGH RISK POPULATION. THIS WILL COLLECT COHORT TO FOLLOW INDIVIDUALS FOR DEVELOPMENT OF PANCREATIC ADENOCARCINOMA, ESTABLISHING A BIOBANK OF CLINICALLY ANNOTATED BIOSPECIMENS, FACILITATE VALIDATION FOR IDENTIFYING SUBJECTS AT HIGH RISK USING CLINICALLY ANNOTATED BIOSPECIMEN REFERENCE SET, PROVIDING A PLATFORM FOR FUTURE DEVELOPMENT OF EARLY DETECTION PROTOCOL IN NEW ONSET DIABETES SUBJECTS INCORPORATION NOVEL IMAGING AS WELL AS OTHER CLINICAL PARAMETERS. NEXT SLIDE PLEASE. WE'LL SOON WELCOME DR. PHIL CASTLE, I'M TOLD EARLY JULY, DIRECTOR OF DIVISION OF CANCER PREVENTION. WE'RE GRATEFUL TO DEBBIE WYNN FOR SUPERB WORK HOLDING THAT JOB IN ACTING CAPACITY FOR MORE THAN A YEAR. I'M ALSO PLEASED TO ANNOUNCE EMILY TONARESOS WILL JOIN NCI AS DIRECTOR OF OFFICE OF CANCER SURVIVORSHIP, DR. TONOREZOS IS AT MEMORIAL SLOAN-KETTERING, SHE'S BEEN SELECTED PENDING CLEARANCE AND I WOULD LIKE TO THANK DEB MAYER AT UNC, SINCE THE RETIREMENT OF JULIA. NEXT SLIDE. FINAL WORD, I'D LIKE TO REMIND YOU OF BOTTOM LINE BLOG. WE'VE CONTINUED TO POST ARTICLES OF PARTICULAR INTEREST TO THE NCI, ABOUT CONCEPTS, CANCER RESEARCH AND COVID-19, CANCER TRAINING DURING THE PANDEMIC. THE RESPONSE HAS BEEN GREAT. I HOPE YOU FOUND IT USEFUL AND YOU'LL CONTINUE TO SPREAD THE WORD AND POINT OTHERS TO THIS WHERE IT CONTAINS A LOT OF INFORMATION FOR GRANTEES AND OTHER INTERESTED STAKEHOLDERS. I'LL LOWS AND LEAVE TIME FOR QUESTIONS. WE HAVE MORE DISCUSSION ON THESE TOPICS TODAY. GOOD SEEING YOU VIRTUALLY AND LET'S SEE IF ANYBODY HAS QUESTIONS. THANK YOU. >> NED, WHEN WILL THE ELISA BE AVAILABLE TO THE COMMUNITY? >> YOU'RE ASKING A SEROLOGY QUESTION, MARTINE, WHEN WILL ELISA TESTS BE AVAILABLE TO THE COMMUNITY, THEY ARE AVAILABLE AT SOME LEVEL, QUEST AND LABCORP NOW HAVE AN ELISA, THEY CALL IT LIKE PATIENT ORIENTED OR WHATEVER, MEANING YOU CAN GET THE TEST WITHOUT SEEING A PHYSICIAN. THERE'S INFORMATION ON BOTH WEBSITES TO HOW TO DO THIS. AS YOU -- I THINK THE MORE IMPORTANT ISSUE IS AT PRESENT HOW TO USE THAT INFORMATION IS EXTREMELY UNCLEAR, AND MANY OF YOU MAY HAVE SEEN THE CDC PUT OUT A GUIDANCE TWO WEEKS AGO SUGGESTING THAT ANTIBODY STATUS SHOULD NOT BE USED FOR RETURN TO WORK DECISIONS OR CHANGES IN PERSONAL BEHAVIOR OR OTHER THINGS LIKE THAT. THE QUESTION REALLY IS WHEN ARE WE GOING HAVE THE DATA AND HOW, TO KNOW HOW TO USE ANTIBODYY TESTING BECAUSE TESTING IS BECOMING MORE AVAILABLE EVERY DAY. >> THIS IS FRANK. HELLO? (INDISCERNIBLE) DUE TO COVID. THAT'S BASED ON DELAYED DIAGNOSIS (INDISCERNIBLE) AND IN THE PATIENT, THAT MIGHT BE CAUSED BY THE -- THAT KNOWLEDGE IS CONSTANTLY BEING UPGRADED. (INDISCERNIBLE). >> I DIDN'T HEAR THE LAST PART OF YOUR QUESTION. >> THE IMPACT OF THE VIRUS ON THE PATIENT, THE CANCER PATIENT. THAT INFORMATION IS BEING ACCRUED AS THE DISEASE IS BETTER UNDERSTOOD. WHAT YOU PREVENTED IS MODEST, AS WE GET MORE UNDERSTANDING OF THE HOST/VIRUS INTERACTION. >> I'LL TAKE A STAB. WE SHOWED EXCESS MORTALITY, NOT A CHANGE IN INCIDENCE BUT REALLY RESULTS OF DELAYED DIAGNOSIS AND DELAYED SCREENING, DEFERRED CARE, COMBINATION OF THOSE THINGS. DID THE ANALYSIS BREAKING IT AT SCREENING OR DEFERRED CARE, WHAT WE SHOWED WAS COMBINATION THEREOF. I THINK YOU'RE RIGHT. CERTAIN POPULATIONS, COVID-19 IS A GREATER THREAT TO THEIR SURVIVAL TODAY THAN 1% INCREASE IN MORTALITY OVER THE NEXT DECADE. THAT'S CLEARLY TRUE. THAT'S WHY WE THINK THAT MANY OF THE VERY IMPORTANT PUBLIC HEALTH MEASURES SEEKING TO LIMIT SPREAD OF CORONAVIRUS IN VULNERABLE POPULATIONS ARE IMPORTANT, SOMETHING THE NCI IS SUPPORTIVE OF AND ENDORSED BUT IT'S ALSO IMPORTANT TO REALIZE AT SOME POINT THESE DELAYS AND DEFERRALS IN CARE WILL HAVE AN IMPACT. YOU KNOW, IF IT WERE 1% ACROSS ALL CANCERS, NO ONE IS SAYING IT IS BECAUSE WE'VE ONLY MODELED BREAST AND COLON, BUT THERE WOULD BE 6 MILLION DEATHS, SO THAT'S LIKE 60,000 DEATHS, THAT STARTS TO ADD UP. WE THINK THAT ANALYSIS IS ON THE CONSERVATIVE SIDE. IF THIS PANDEMIC WERE TO DISRUPT CARE FOR A VERY LONG TIME, MORE THAN SIX MONTHS, IT COULD GET WORSE. REALLY TO ASK HOSPITALS TO BE INNOVATIVE, FIGURING OUT HOW TO GET PATIENTS BACK IN AND START SCREENING AND (INDISCERNIBLE) ONGOING FOR A WHILE. >> THIS IS LIZ. I WANTED TO FOLLOW UP. IT WAS A GREAT SUMMARY. IS THERE ANY WAY THAT THE NCI CAN PARTNER WITH THE CANCER CENTERS TO, . >> THE THINGS THAT ARE REALLY IMPORTANT TO STARTING THIS OUT. >> THANK YOU FOR THE COMMENT, DEB. I DON'T DISAGREE. I THINK GETTING BETTER DATA IS IMPORTANT FOR MANY AREAS THE NCI WORKS, AND I THINK AS I SAID OF RESEARCH IS REALLY NOW. IT'S A GOOD OPPORTUNITY. WE WILL HAVE PRESENTATION LATER TODAY ABOUT THE NCCAPS OR CLINICAL TRIALS IN GEN, AND JIM CAN SPEAK MORE SPECIFICALLY ABOUT DATA COLLECTION REGARDING SOCIAL DETERMINANTS OF HEALTH AND OTHER AREAS AT THAT TIME, UNLESS JIM WANTS TO SAY SOMETHING NOW AND I'LL LET HIM PIPE UP BUT OTHERWISE WE CAN DEFER TO HIS PRESENTATION. ANYTHING ELSE? THANK YOU, LIZ, TAKE IT AWAY. >> NEXT IS M.K. HOLOHAN, LEGISLATIVE REPORT. M.K.? >> GOOD MORNING. THANK YOU FOR THE OPPORTUNITY TO SPEAK WITH YOU TODAY. CAN I HAVE THE SLIDE PLEASE? OKAY, THANK YOU. THANK YOU SO MUCH. NEXT SLIDE PLEASE. I'M GOING TO GIVE YOU A BRIEF UPDATE. THERE IS MORE DETAIL ON ALL OF THE ITEMS I'M GOING TO DISCUSS IN THE LEGISLATIVE UPDATE SENT WITH MEETING MATERIALS. AS ALWAYS, I'M GLAD TO SPEAK WITH ANY BOARD MEMBERS OR STAFF OFFLINE IF YOU HAVE PARTICULAR QUESTIONS ABOUT ANY OF THE SPECIFICS I'M COVERING. WE'LL COVER CONGRESSIONAL OPERATIONS AND HOW THOSE HAVE CHANGED, COVID-19 FUNDING AND WHAT CONGRESS HAS BEEN BUSY DOING, FY20 21 APPROPRIATIONS PROCESS WHERE THINGS STAND AND OTHER LEGISLATIVE ISSUES WE MAY SEE EMERGING IN THE NEXT COUPLE OF MONTHS. NEXT SLIDE. SO, OBVIOUSLY THE CHANGES THAT THE PANDEMIC HAVE BROUGHT ABOUT THROUGHOUT THE COUNTRY ARE MIRRORED IN CONGRESS, THE MOST OBVIOUS BEING THE MASK WEARING ACROSS MEMBERS. MY PARTICULAR FAVORITE IS THE UPPER LEFT CORNER, SENATOR TIM KANE AT A HEALTH COMMITTEE HEARING, THIS LED TO A FAVORITE TWEET, SOMEONE SAYING WHEN YOU HAVE A SENATE HEARING AT TEN, STAGE COACH ROBBERY AT NOON, ALL JOKES ASIDE, WE'VE SEEN POLITICIZATION IN SOME AREAS OF THE COUNTRY, FOR THE MOST PART MEMBERS ARE CAREFUL IN CONGRESSIONAL BUILDINGS, WE'RE SEEING DISTANCING AND MASK WEARING WHEN THERE ARE MEMBERS PRESENT. NEXT SLIDE PLEASE. ONE OF THE PROBLEMS WITH THE CONGRESS IS REALLY NOT VERY WELL SUITED TO TELEWORKING. IT'S NOT SOMETHING THAT'S DONE BY STAFF. THEY SORT OF EXIST TO COME TOGETHER. THE LATIN WORD CONGRESSIVE IS WHERE THE WORD CONGRESS COMES FROM. THE TWO THAT SEEM MOST APPROPRIATE FOR CONGRESS, HOW THEY ARE IN THE MODERN TIMES, IS I THINK WHAT MOST MEMBERS WOULD AGREE WITH, FIRST CHARACTERIZATION OF FRIENDLY MEETINGS, HOSTILE ENCOUNTER, THE ACT OF COMING TOGETHER AND MEETING. PHYSICAL PRESENCE IS JUST PART OF THE CULTURE. IT IS A WAY THAT -- IT'S THE WAY THEY WORK. YOU CAN'T BE PART OF THREATENING FILIBUSTERS FROM THE FAIR ROOM. THE BOTTOM IS COTS WHEN THERE'S A THREAT OF FILIBUSTER, ONE MIGHT HOLD THE FLOOR ALL NIGHT TO HOLD UP LEGISLATION. MEMBERS ARE JUDGED BY HOW THEY VOTE BUT IF THEY VOTE. WE'VE ALL SEEN POLITICAL ADS WHERE AN OPPONENT IS CRITICIZING THEIR COUNTERPART BECAUSE THEY SKIPPED 40% OF VOTES OR SOMETHING LIKE THAT. SO GOING TO REMOTE VOTING IS VERY CULTURALLY DIFFICULT FOR CONGRESS. AND WE'VE ALL SEEN DRAMATIC VOTES WHERE SENATOR EDWARD KENNEDY IN 2008 WHEN RECOVERING FROM SURGERY FOR GLIOBLASTOMA RETURNED TO CAST A VOTE. SENATOR JOHN McCAIN RECOVERING, RETURNED TO THE SENATE TO CAST DECIDING VOTE TO PROTECT HEALTH CARE REFORM. AND A LESS RECENT BUT REALLY INTERESTING EXAMPLE I UNCOVERED IS SENATE SENATOR CLAIRE ENGVALL ALSO RECOVERING FROM GLIA BLASTOMA, RETURNED IN 1964 TO CAST A VOTE TO SHUT DOWN A FILIBUSTER PREVENTING 1964 CIVIL RIGHTS ACT, AND THE CONGRESSMAN WAS UNABLE TO SPEAK BUT HE POINTED TO HIS EYES INDICATING HE WAS VOTING AYE, DRAMATIC HISTORY, UNCOMFORTABLE FOR CONGRESS TO MOVED TO REMOTE APPLICATIONS AND THE ADOPTION HAS BEEN SORT OF ERRATIC. NEXT SLIDE PLEASE. IT WASN'T UNTIL MAY 15 THAT WE SAW THE HOUSE PASS A RULE THAT ALLOWED FOR PROXY VOTING FOR FLOOR VOTES. IT'S EASIER FOR THE SENATE. THERE'S 100 MEMBERS. THERE'S EASIER FOR THEM WITH THOSE NUMBERS TO SPACE OUT, HAVE PHYSICAL DISTANCING AND PERHAPS NOT ALL MEMBERS OF THE COMMITTEE SHOW UP TO DO BUSINESS AND VOTE OVER TIME. WITH THE HOUSE, THERE'S CURRENTLY 430 MEMBERS, FIVE VACANCIES, NORMALLY THERE WOULD BE 435. FOR THEM IT'S MUCH HARDER. WE SAW THREE TIMES, FOUR TIMES THAT CONGRESS PRIOR TO PASSING THIS REMOTE PROXY VOTE RESOLUTION HUNDREDS OF MEMBERS OF CONGRESS CAME TO VOTE ON THE CORONAVIRUS FUNDING BILLS. YOU KNOW, TRAVELING IN PLANES, DRIVING FOR -- ONE MEMBER FROM IDAHO REPORTED DRIVING 31 HOURS TO VOTE BECAUSE TRAVEL WAS NOT RELIABLE. THERE'S NOT THAT MANY FLIGHTS ANYWAY FOR HIM. SO THIS IS A BIG CHANGE. SOME OPPOSITION RELATES TO CONCERN THERE'S A FAVOR, FAVORS MAJORITY, COMMITTEE PROCESS MIGHT NOT BE TRANSPARENT. SO THIS RULE IS TEMPORARY. IT'S AUTHORIZED FOR 45 DAYS FOR THE HOUSE, CAN BE EXTENDED DEPENDING ON CONDITIONS, BUT GOOD TO SEE WE'RE NOT HAVING IN TIMES OF INCREASING CASES AT THIS POINT MEMBERS FLOCKING IN THE HUNDREDS TO VOTE IN D.C. THIS WAS A MARCH 3 SENATE HEALTH LABOR AND PENSION COMMITTEE HEARING, FEDERAL RESPONSE TO THE CORONAVIRUS OUTBREAK. YOU CAN SEE WITNESSES ARE SHOULDER TO SHOULDER AT COMMITTEE, AUDIENCES IN CLOSE PROXIMITY TO ONE ANOTHER, THE MEMBERS ARE CLOSE TOGETHER. NEXT SLIDE. WHAT WE SEE NOW ON MAY 12, THIS WAS A RECENT SENATE HEARING COMMITTEE, GETTING BACK TO WORK AND BACK TO SCHOOL. AND YOU SEE MUCH LARGER ROOM, VERY VIEW SENATORS VERY SPACED OUT, MOST WERE ATTENDING REMOTELY. NEXT SLIDE PLEASE. AND INTERESTINGLY FOR THIS HEARING ALL OF THE WITNESSES WERE APPEARING REMOTELY, THAT WAS BECAUSE DR. HAHN, DR. FAUCI AND DR. REDFIELD WERE SELF QUARANTINING, AND THE SENATOR QUARANTINING. HEARINGS HAVE GONE LONG BECAUSE OF CYCLE OF TAKING QUESTIONS, HAVE GONE ON AND ON FOR ROUNDS OF QUESTIONS, BUT THEY SEEM TO BE FINDING A WAY TO CONDUCT THEIR BUSINESS. NET SLIDE PLEASE. FOR THE HOUSE THIS SHOULD BE A TREMENDOUS BENEFIT AS THEY MOVE TOWARDS WHAT WILL HAVE HAPPEN NEXT FOR THE NEXT CORONAVIRUS FUNDING PACKAGE. SO CONGRESS HAS REALLY MOVED INCREDIBLY RAPIDLY TO ADDRESS THE ECONOMIC IMPACT OF THE CORONAVIRUS, WITHIN 50 DAYS THEY DEVELOPED, PASSED, AND HAD ENACTED FOUR SEPARATE SPENDING PACKAGES TOTALING 2.6 TRILLION. SOMETIMES YOU'LL HEAR PEOPLE SAY THEY ARE STILL WAITING FOR THE FOURTH BILL BECAUSE THE ACTUAL FOURTH PIECE OF LEGISLATION PASSED IN APRIL IS REALLY -- IT PROVIDED ADDITIONAL FUNDING FOR PROGRAMS ALREADY PUT IN PLACE IN AN EARLIER PACKAGE. SO SOMETIMES YOU'LL HEAR IT REFERRED TO AS 3.5, 3B, THERE HAVE BEEN FOUR PIECES THUS FAR. THE FIFTH, WHAT WILL BE IN THE FIFTH IS THE SUBJECT OF MUCH DEBATE RIGHT NOW. SO NEXT SLIDE PLEASE. NIH HAS RECEIVED FUNDING IN THREE OF THE PAST FOUR COVID-19 SUPPLEMENTAL BILLS. IN THE MOST RECENT, THE 3.5 BILL THAT PASSED IN APRIL, WE HAVE SEEN A TOTAL OF $3.6 BILLION FOR NIH, NIH RECEIVED $306 MILLION IN THE MOST RECENT FUNDING PACKAGE, THIS WAS ACTUALLY THE LARGEST PACKAGE FOR NIH TOTAL WITH A $1.8 BILLION APPROPRIATION. NEXT SLIDE PLEASE. THE NCI $306 MILLION, AND WE'LL HEAR MORE FROM DR. LOWY AND OTHERS, IS SPECIFIC FOR DEVELOP THE, VALIDATION, IMPROVEMENT AND IMPLEMENTATION OF SEROLOGIC TESTING AND ASSOCIATED TECHNOLOGIES. THIS IS COVID-19 FOCUSED, DISTINCT FROM OUR ANNUAL APPROPRIATION, IT IS DIFFERENT, IT WILL BE TRACKED DIFFERENTLY, MONEY IS AVAILABLE FOR DIFFERENT AMOUNTS OF TIME, ENTIRELY DISTINCT FROM NCI REGULAR APPROPRIATION. NEXT SLIDE PLEASE. CONGRESS IS VERY INTERESTED IN OBVIOUSLY CORONAVIRUS TESTING, IT'S BEEN CHALLENGING, DIAGNOSIS TESTING, INTERESTED IN ANTIBODY TESTING, MANY BRIEFINGS, HEARINGS, REQUEST FOR INFORMATION FROM HHS, NCI HAS BEEN INVOLVED WITH SOME OF THOSE REQUESTS. WHAT WE'RE SEEING NOW ARE DISCUSSIONS AND DISCUSSIONS ARE INTENSIFYING WITH SOME OF THE NOT POSITIVE ECONOMIC DATA ABOUT U.S. STOCK FUTURES IN THE PAST FEW DAYS, ABOUT WHAT CONGRESS SHOULD DO NEXT. SO ALSO ON MAY 15, THE HOUSE PASSED THEIR VERSION, THEIR SORT OF WISH LIST OF THE NEXT FUNDING PACKAGE. AND THEIRS IS THE HEROES ACT. IT'S A $3 TRILLION PRICE TAG. IT'S A LOT OF MONEY. THAT IS MORE THAN ALL OF THE OTHER ECONOMIC AID PACKAGES COMBINED. THERE'S ABOUT 2.7, 2.6 IN THE OTHERS. THIS IS $3 TRILLION, BIGGEST APPROPRIATION BILL EVER IN FACT. SO THEY WERE NOT ABLE TO GET THE SENATE TO START NEGOTIATING WITH THEM, AND THE SENATE WANTED TO MOVE AT A DIFFERENT PACE. MAJORITY LEADER MCCONNELL WANTED TO WAIT AND SEE WHAT HAPPENS. OTHERS SAID LET'S NOT RUSH. HOUSE DEMOCRATS DECIDED TO GO WITH THEIR BILL. THEIR PRIORITIES IN ADDITION TO FUNDING, SOME FUNDING SPECIFICALLY GOING TO STATE AND LOCAL GOVERNMENT. WHAT WE'VE HEARD FROM THE SENATE IS THAT LEADER MCCONNELL'S PRIORITY IS LIABILITY PROTECTION FOR EMPLOYERS AND CORPORATIONS. HE WANTS SOMETHING MORE IN THE $1 TRILLION RANGE. OVER THE WEEKEND THE WHITE HOUSE, PETER NAVARRO MADE STATEMENTS ABOUT THE PRESIDENT LOOKING FOR $2 TRILLION FUNDING PACKAGE, AND WANTING PAYROLL TAX CUTS. SO IT'S NOT CERTAIN WHETHER THAT IS 100% OF FEDERAL TAXES, HOW LONG THAT WOULD BE IN PLACE, THAT IS A PROVISION THAT THE DEMOCRATS HAVE BEEN OPPOSED TO FOR SEVERAL REASONS, IT ONLY AFFECTS AND BENEFITS PEOPLE WHO ARE GETTING PAYCHECKS, WHICH IS OBVIOUSLY NOT EVERYONE WITH OVER 21 MILLION AMERICANS UNEMPLOYED. AND THEY ARE CONCERNED ABOUT SHORTFALLS IN SOCIAL SECURITY AND MEDICARE FUNDING, NOT CONTRIBUTING TO THOSE PROGRAMS DURING THE TIME OF THE PAYROLL TAX CUT. WHAT WE DID SEE THAT WAS ACTUALLY VERY ENCOURAGING TO US IN THIS HEROES ACT, ALTHOUGH IT WAS A PARTISAN BILL, IT'S A DEMOCRATIC WISH LIST, THERE WAS OVER WILL $4 BILLION FOR NIH, HOW RESEARCH CENTERS HAVE BEEN AFFECTED BY THE VIRUS AND SHUTDOWN, THAT WAS ENCOURAGING AND WE'RE HOPEFUL THAT ANY BIPARTISAN NEGOTIATION THAT SOMETHING LIKE THAT WILL SURVIVE. I THINK ALL SIGNS INDICATE IT WILL. IT'S INTERESTING THIS VOTE WAS 209-199. 14 DEMOCRATS VOTED AGAINST THE BILL. SOME ARE UP FOR REELECTION. WE MAY SEE THE PACE PICKING UP AT THIS POINT WITH SOME RECENT ECONOMIC DATA. NEXT SLIDE PLEASE. APPROPRIATIONS OUTLOOK, NOT THAT LONG UNTIL THE NEXT FISCAL YEAR BEGINS. APPROPRIATORS CONTINUED TO WORK ON THE BILLS WITH A REGULAR HEARING ON MARCH 4, DR. SHARPLESS TESTIFIED, THE LAST NORMAL-LOOKING HEARING FOR SOME TIME. SENATE HEARING SCHEDULED FOR THE 26th OF MARCH, POSTPONED, NOT HAPPENING NOW. COMMITTEES ARE BEGINNING MARKUPS NEXT WEEK. THE SENATE IS GOING BEFORE THE HOUSE, WHICH IS UNUSUAL AND OUT OF ORDER BUT THAT IS WHEN THEY ARE GOING TO TACKLE THOSE. SO WE'RE HOPING WE'LL SEE MOVEMENT FAIRLY QUICKLY. IT'S NOT THAT LIKELY BILLS ARE ENACTED AT OR SOON AFTER THE START OF THE FISCAL YEAR GIVEN THIS IS AN ELECTION YEAR, LIKELY THERE WILL BE A CONTINUING RESOLUTION, IT'S NOT CERTAINTY BUT IT'S LIKELY, UNTIL AFTER THE NOVEMBER ELECTIONS, AT THAT POINT IF MAJORITIES CHANGE IT COULD BE THE CASE LAME DUCK CONGRESS DOESN'T WANT TO GO WITH BILLS AS WRITTEN BY 116th CONGRESS. THEY WANT TO TRY TO HAVE A CRACK AT CHANGING ALLOCATIONS AS MAJORITY CHANGES, SO IT COULD BE PUNTED TILL THE NEXT CONGRESS IN JANUARY. THAT'S SOMETHING WE'RE JUST GOING TO HAVE TO WATCH AND SEE. THERE'S NO CERTAINTY THERE. ANOTHER PIECE OF REALITY THAT MAY BE A COMPLICATION IS CERTAINLY A COMPLEXITY TO LEGISLATING IN THE SUMMER, IS THAT IT'S CLEAR THERE'S GOING TO BE SOME POLICE REFORM LEGISLATION. THERE HAVE BEEN SOME BILLS IN THE HOUSE. THERE'S A BILL INTRODUCED THIS WEEK IN THE SENATE. A SECOND BILL INTRODUCES THIS WEEK IN THE SENATE, SO THAT'S GOING TO BE SOMETHING THAT'S GOING TO HAVE A LOT OF ATTENTION, WE ANTICIPATE THAT BEING -- PRESSURE BEING ON FOR THAT TO BE COMPLETED BEFORE THE ELECTION IN NOVEMBER. NEXT SLIDE PLEASE. AS YOU CAN SEE FOR THIS CONGRESSIONAL CALENDAR, THERE'S VERY LITTLE TIME LEFT. THE PURPLE BLOCKS SHOW WHEN BOTH CHAMBERS ARE SCHEDULED TO BE IN SESSION. SO NOT MUCH TIME FOR THESE BILLS TO BE ENACTED AND PASSED EVEN THOUGH THERE'S REMOTE VOTING ALLOWED IN THE HOUSE, IT'S NOT THE CASE IN THE SENATE. AND SO JUST IN TERMS OF COMING TOGETHER TO ACTUALLY NEGOTIATE SOME OF THESE ARE DIFFICULT NEXT STEPS WITH LEGISLATION. THERE'S NOT A LOT OF TIME. NOT A LOT OF TIME BEFORE THE ELECTION. SO, THAT'S WHERE THINGS STAND WITH THE CONGRESSIONAL OUTLOOK NOW. I'M HAPPY TO TAKE ANY QUESTIONS EITHER NOW OR OFFLINE. THANK YOU FOR YOUR TIME. >> THANKS, M.K. THIS IS LIZ. I HAD TWO QUESTIONS RELATED. IN ALL OF THIS DISCUSSION ON THE HILL, HAVE THEY TALKED ABOUT ALLOCATING SIGNIFICANT FUNDS FOR UNIVERSITY MEDICAL CENTERS WHICH ARE REPORTEDLY WORRIED THEY ARE GOING TO HAVE BETWEEN 150 AND 300 MILLION IN DEFICITS, AND THE SECOND PART OF THE QUESTIN DO THEY TALK ABOUT THE EARLY CAREER AND TRAINEES WHO ARE PROBABLY GOING TO SUFFER THE MOST IN RESEARCH, YOU KNOW, OBVIOUSLY WE'RE INTERESTED IN CANCER RESEARCH BUT IN ANY AREA OF RESEARCH DUE TO COVID AND THE SLOWING OF WHAT'S HAPPENED AT UNIVERSITY CENTERS? >> SURE, YEAH, I THINK THAT THOSE ARE PART OF THE CONSIDERATIONS FOR THE RESTART MONEY, AND FOR JUST OTHER FUNDING TO NIH. WE OBVIOUSLY DON'T KNOW WHAT THAT'S GOING TO LOOK LIKE BUT I THINK THERE'S TREMENDOUS CONCERN ABOUT ACADEMIC INSTITUTIONS, PRIVATE ENTITIES, AND, YOU KNOW, NOT -- AS DR. SHARPLESS WAS TALKING ABOUT NOT COMPROMISING MOMENTUM FOR ALL THOSE ENDEAVORS SO I DO THINK ONE WAY WE'RE SEEING SOME DISCUSSION ABOUT THAT, AND IT'S POSSIBLY TANGENTIAL BUT TELEMEDICINE. THIS IS A MOMENT FOR TELEMEDICINE. WE MIGHT SEE IN THE NEXT FUNDING PACKAGE PROVISIONS FOR MAKING PERMANENT SOME CMS POLICY CHANGES ABOUT TELEMEDICINE, EXPANDING THOSE, WHICH WILL INEVITABLY ALSO END UP IN A DISCUSSION ABOUT BROADBAND, SOME COMMUNITIES DON'T HAVE THAT, THEY ARE DOING TELEPHONE MEDICINE. AND ALSO PRIVACY CONSIDERATIONS ABOUT HEALTH I.T. AND CONTACT TRACING AND THINGS LIKE THAT, WHICH IS A DIFFERENT ISSUE. BUT I THINK THERE'S -- THERE WILL BE CONTINUED PRIORITIZATION OF EARLY-STAGE INVESTIGATORS AND THE NEXT GENERATION BECAUSE THAT HAS BEEN A PARTICULAR FAVORITE INTEREST. I GUESS THE CONCERN IS THOSE GROUPS WILL BE AFFECTED MORE THAN OTHERS, PROFESSIONALLY. IT'S A GREAT QUESTION. THANK YOU. >> THANK YOU. ANY OTHER QUESTIONS FOR M.K.? THANK YOU VERY MUCH. THIS WAS TERRIFIC. WE APPRECIATE IT. NEXT UP WE'LL HEAR ABOUT COVID-19 SEROLOGY AND IMMUNOLOGY CAPACITY, AND DOUG LOWY IS GOING TO PRESENT. >> THANKS VERY MUCH, LIZ. GOOD MORNING, EVERYONE. IF WE COULD HAVE THE FIRST SLIDE. THANK YOU. I AM GOING TO CONTINUE TALKING ABOUT SOMETHING THAT I STARTED AT THE JOINT BOARD MEETING BACK IN APRIL. BUT IT IS NOT GOING TO BE A TWICE-TOLD TALE BECAUSE THERE'S A LOT OF PROGRESS SINCE THEN. AND IN ADDITION, THE SEROLOGY SCIENCE NETWORK THAT NED REFERRED TO HAS ALREADY BEEN PRESENTED TO THE BOARD OF SCIENTIFIC ADVISORS, SO I WILL BE DISCUSSING THAT AS WELL. COULD WE HAVE THE FIRST SLIDE PLEASE? ACTUALLY THE SECOND SLIDE. I AM GOING TO COVER THREE THINGS IN MY PRESENTATION. FIRST, THE NOTION OF THE FREDERICK NATIONAL LABORATORY BEING USED BY THE INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES FOR RESPONDING. SECOND, FOR THE FREDERICK NATIONAL LAB USING THE EXPERTISE IN SEROLOGY AS NCI RESPONDS TO THE EPIDEMIC. AND THIRD, THE PROPOSED SEROLOGICAL SCIENCES NETWORK, WHICH DINAH DISCUSSED WITH THE BSA PREVIOUSLY. I'M ON SLIDE THREE. CAN PEOPLE HEAR ME? >> YES, BUT NO SLIDES. >> I THOUGHT THE SLIDES WERE BEING PRESENTED CENTRALLY. >> THEY ARE BEING PRESENTED. THEY ARE HAVING A NETWORK ISSUE. THEY SHOULD BE UP SHORTLY. >> OKAY, THANK YOU. IN THE INTEREST OF TIME, I WILL CONTINUE. SLIDES WILL BE MADE AVAILABLE TO EVERYONE SO THAT YOU'LL BE ABLE TO SEE THEM LATER. SO NIAID, AS I MENTIONED BACK IN APRIL, HAS MADE EXTENSIVE USE OF FREDERICK NATIONAL LABORATORY TO RESPOND TO OTHER EPIDEMICS SUCH AS SARS, EBOLA, ZIKA. I MENTIONED THEY HAD INITIATED THE REMDESAVIR TRIAL, AND THAT THIS WAS THROUGH THE FREDERICK NATIONAL LABORATORY, THAT THE TRIAL WAS SET UP IN A VERY RAPID MANNER, IT'S AN INTERNATIONAL TRIAL. WE'RE ABOUT 60 TO 70% FROM THE UNITED STATES, BUT THE OTHER 30 TO 40% WAS FROM OTHER COUNTRIES, ASIA, EUROPE, AND THE RESULTS WERE PRESENTED IN AN OVAL OFFICE MEETING BACK IN APRIL. AND JUST TO REMIND YOU, REMDESAVIR IS A NUCLEOSIDE ANALOG, IT FUNCTIONS AS AN RNA CHAIN TERMINATOR. IT WAS ORIGINALLY DEVELOPED FOR TREATMENT OF EBOLA AND MARBURG VIRUS INFECTION, FOUND TO INHIBIT REPLICATION OF OTHER RNA VIRUSES INCLUDING CORONAVIRUSES. ON APRIL 29, TONY FAUCI AT THE WHITE HOUSE ANNOUNCED THAT THE TRIAL HAD ACTUALLY REACHED AN ENDPOINT, WHERE PATIENTS ON REMDESAVIR TREATMENT IMPROVED FASTER THAN THOSE ON PLACEBO. AND THE TRIAL WAS PUBLISHED IN -- IF WE COULD GO TO SLIDE 4. THE NEXT SLIDE. THANK YOU. ANOTHER. THIS IS AN OLD VERSION OF MY SLIDES. IT WAS PUBLISHED MAY 22, VITAL ET AL. PUBLISHED IN THE NEW NEW ENGLAND JOURNAL OF MEDICINE WITH THE RESULTS. THE RESULTS INDICATED THAT REMDESAVIR TREATMENT, THE PATIENTS IT WAS ALL PATIENTS WHO WERE HOSPITALIZED, THE PATIENTS WERE DISCHARGED 31% PASTER THAN PATIENTS WHO WERE ON PLACEBO. THE -- AND THE LOWER -- THERE WAS A LOWER 14-DAY MORTALITY RATE FOR REMDESAVIR, I'M ON MY SLIDE NUMBER 6 NOW. BUT IT DID NOT QUITE ACHIEVE STATISTICAL SIGNIFICANCE. THE P-VALUE WAS EQUAL TO .059. THE PLACEBO GROUP, THE MORTALITY RATE WAS 11.9%. WHEREAS IN THE REMDESAVIR GROUP, IT WAS 7.1%. SO THE HAZARD RATIO WAS .70, BUT AS I MENTIONED, THE P-VALUE DID NOT -- YES, THERE IT IS. THANK YOU. THE P-VALUE DID NOT QUITE MAKE IT. IT WAS .059. NEXT SLIDE PLEASE. SO, A JOURNALIST IN THE "WASHINGTON POST" LAST MONTH SAID NO ONE WANTS TO HAVE COVID-19, BUT EVERYONE WANTS TO HAVE HAD IT. AND I USE THIS AS KIND OF AN INTRODUCTION FOR THE SEROLOGICAL STUDIES THAT HAVE BEEN CONDUCTED AT THE FREDERICK NATIONAL LABORATORY. NEXT SLIDE PLEASE. AS M.K. HAS MENTIONED, THE NCI RECEIVED THIS $306 MILLION APPROPRIATION SPECIFICALLY FOR COVID-19, AND DISTINCT FROM THE ANNUAL APPROPRIATION. NEXT SLIDE PLEASE. AND WE HAVE BENEFITED FROM AN INCREDIBLE COLLABORATION, PRIMARILY OTHER PARTS OF NIH AND THE DEPARTMENT OF HEALTH AND HUMAN SERVICES, NIAID, FDA, CDC, AND BARDA, AND ALSO MOUNT SINAI, WHERE RAMON PARSONS, FLOORIAN KRAMER AND COLLEAGUES HAVE REALLY BEEN VERY HELPFUL. AND AS NED MENTIONED IN ADDITION, OTHER CANCER CENTERS AS WELL. THE SHORTER TERM GOALS HAVE BEEN TO CHARACTERIZE PERFORMANCE OF SEROLOGIC ASSAYS CORRELATE WITH NEUTRALIZATION AND CROSS-REACTIVE SERA, CORRELATED WITH SEROLOGIC TESTS, TO UNDERSTAND IMPLICATIONS OF BEING SEROPOSITIVE, DOES THIS REALLY MEAN RESISTANCE TO REINFECTION, AND DURATION OF SEROPOSITIVE ITY AND I'LL HAVE MORE TO SAY IN A FEW MINUTES. CO-ORIENTED RESEARCH PROJECTS, AND JIM DOROSHOW WILL BE MENTIONED TO YOU ONE OF THOSE PROJECTS. NEXT SLIDE PLEASE. THE FDA HAD ISSUED A NUMBER OF PRESS RELEASED WHERE FIRST IN MARCH 16 THEY PERMITTED SALE OF COMMERCIAL LABORATORY BASED RAPID LATERAL FLOW SARS-COV-2 DEVICES WITHOUT ASSESSING PERFORMANCE. THE SEROLOGY DEVICES IMPORTANTLY ARE NOT USED TO DIAGNOSE CURRENT INFECTION. THAT'S MEASURING VIRAL RNA OR VIRAL PROTEIN. THIS INSTEAD IS MEASURING ANTIBODIES. DURING THIS INITIAL PERIOD, THERE WAS A LOT OF HETEROGENEITY IN THE QUALITY OF THE DEVICES THAT WERE AVAILABLE. BUT AT THE BEGINNING OF MAY, THE FDA GAVE EMERGENCY USE AUTHORIZATION TO SEVERAL COMMERCIAL DEVICES, AND REQUIRED THAT ALL OTHER MANUFACTURERS WOULD SUBMIT EMERGENCY USE AUTHORIZATIONS, EUA REQUESTS, WITHIN TEN BUSINESS DAYS. AND SOME OF THE EMERGENCY USE AUTHORIZATIONS WAS BASED ON -- THEY TOOK ADVANTAGE OF DATA THAT HAD BEEN DEVELOPED AT THE FREDERICK NATIONAL LABORATORY IN THE SEROLOGY LABORATORY. AND THEN ABOUT TEN DAYS AGO, THE FDA GAVE EMERGENCY USE AUTHORIZATION FOR SEVERAL DEVICES. THIS SLIDE SUMMARIZES -- NEXT SLIDE PLEASE. THIS SUMMARIZES THE RESULTS OF THE INITIAL 40 COMMERCIAL SEROLOGY DEVICES THAT HAVE BEEN EVALUATED BY THE FREDERICK NATIONAL LABORATORY SEROLOGY LABORATORY. WE HAVE TESTED BOTH IgM AND IgG ANTIBODY TESTS. BUT I THINK THAT PEOPLE SHOULD BE FOCUSED MORE ON THE IgG ANTIBODY TESTS BECAUSE IgM AND IgG IN THIS DISEASE BECOME POSITIVE AT ABOUT THE SAME TIME, BUT IgM GOES DOWN FASTER THAN IgG. WHAT WE'VE FOUND IN THIS ANALYSIS IS THAT THE SENSITIVITY FOR THE VARIOUS DEVICE, ABILITY TO DETECT TRUE POSITIVES, VERY ENORMOUSLY. SOME OF THEM WERE EXTRAORDINARILY GOOD, BEING IN THE 90 TO 100% RANGE BUT SOME DEVICES WERE NOT VERY GOOD, AND HAD SENSITIVITY THAT WAS WELL BELOW THAT AND ONE AS LOW AS 30%. SPECIFICITY WAS ALSO QUITE VARIABLE. AND I'LL HAVE SOMETHING TO SAY ABOUT THAT IN THE SUBSEQUENT SLIDE. THE SPECIFICITY IS TO TRY -- IT'S THE EFFICIENCY WITH WHICH YOU DON'T ATTEMPT FALSE POSITIVES. AND IT VARIED FROM A HIGH OF 100% TO A LOW OF 87%. THE RESULTS WERE SENT TO THE FDA TO HELP FDA DETERMINE SUIT BUILT FOR EMERGENCY USE AUTHORIZATION. THE FDA HAS MADE SOME NCI EVALUATION RESULTS PUBLICLY AVAILABLE AND OTHERS WILL BE RELEASED IN THE NEAR FUTURE. AND MY EXPECTATION IS THAT BECAUSE OF THE INCREASED STRINGENCY ONLY THOSE WITH HIGH SPECIFICITY SHOULD BE AVAILABLE IN THE UNITED STATES. NEXT SLIDE PLEASE. THIS SLIDE DEPICTS FOR YOU THE IMPORTANCE OF SPECIFICITY AT LOW RATES OF SEROPREVALENCE. THE VAST MAJORITY OF THE UNITED STATES WITH POSSIBLE EXCEPTION OF PERHAPS FIRST RESPONDERS OR HEALTH CARE WORKERS IN NEW YORK AND A FEW OTHER PLACES, THE SEROPREVALENCE IS ACTUALLY QUITE LOW, WELL BELOW 10% IN VIRTUALLY ALL AREAS OF THE UNITED STATES, WHEN YOU LOOK ON A STATEWIDE LEVEL RATHER THAN LOOKING AT SPECIFIC POPULATIONS SUCH AS NURSING HOMES, YOU KNOW, OR MEAT PROCESSING PLANTS. BUT IF YOU LOOK AT THIS SLIDE, IF A TEST HAS 99% SPECIFICITY, WHICH WE WOULD CONSIDER A VERY GOOD TEST, AND THE SEROPREVALENCE IS FOUND TO BE AT 5%, 20% OF THE POSITIVE WILL BE FALSE POSITIVE. 1 OUT OF 5 OF POSITIVES WILL BE FALSE POSITIVES. IF YOU NOW DROP DOWN TO THE SECOND BULLET POINT, IF A TEST HAS 95% SENSITIVITY, WHICH YOU USUALLY THINK ABOUT AS BEING QUITE GOOD, AND THE SEROPREVALENCE WAS FOUND TO BE 5%, AT THAT POINT 50% OF THE POSITIVES WILL BE FALSE POSITIVES, WHICH MEANS THERE'S A TREMENDOUS FALSE ERROR RATE. THAT IS WHY IT'S SO IMPORTANT FOR THE CURRENT TEST TO HAVE VERY HIGH SPECIFICITY. NEXT SLIDE PLEASE. SO, I WANT TO GO OVER WITH YOU SOME OF THE QUESTIONS THAT CURRENTLY ARE UNKNOWN AND BEING ADDRESSED BY RESEARCH. FIRST, BEING ANTIBODY POSITIVE MEANS EITHER THE PERSON IS CURRENTLY INFECTED WITH SARS-COV-2 OR HAS BEEN PREVIOUSLY INFECTED. SECOND, YOU CAN NOW USE THE TEST FOR SEROPREVALENCE STUDIES, IT SHOULD IDENTIFY MOST PEOPLE WHO HAD ASYMPTOMATIC OR SYMPTOMATIC INFECTION. HOWEVER, A SMALL MINORITY OF PEOPLE MAINLY THOSE WITH ASYMPTOMATIC INFECTION MAY REMAIN ANTIBODY NEGATIVE. THIRD BULLET POINT WHICH IN MANY WAYS IS THE MOST IMPORTANT, IT'S NOT CURRENTLY KNOWN WHETHER BEING ANTIBODY POSITIVE IS ASSOCIATED WITH PROTECTION AGAINST REINFECTION. WHAT ANTIBODY LEVELS MAY BE ASSOCIATED WITH PROTECTION, AND HOW LONG PROTECTION AND ANTIBODY LEVELS WILL LAST. AND THEREFORE, WE THINK THAT ANTIBODY TITERS ARE LIKELY TO BECOME IMPORTANT AND WE ARE IN THE PROCESS OF DEVELOPING QUANTITATIVE ASSAYS AND I THINK IN THE NEAR FUTURE THE FDA WILL ALSO BE EVALUATING QUANTITATIVE ASSAYS. FOR CANDIDATE POLYCLONAL ANTIBODIES FROM CONVALESCENT SERA AND NEUTRALIZING ANTIBODIES CURRENTLY BEING INITIATED IN CLINICAL TRIALS, WILL THEY REDUCE THE RISK OF SERIOUS DISEASE? IT REMAINS TO BE SEEN. IF THEY DO, IT WILL IMPLY THAT THE CANDIDATE SARS-COV-2 VACCINES WHICH MAINLY WE THINK WILL FUNCTION BY INDUCING NEUTRALIZING ANTIBODIES WOULD BE MORE LIKELY TO CONFER PROTECTION. THE PHASE 3 TRIALS FOR THE VACCINES WILL BE STARTING SOMETIME NEXT MONTH, AS MANY OF YOU HAVE HEARD, BUT THEY WILL BE RANDOMIZED CONTROLLED TRIALS THAT WILL LOOK AT EVALUATING WHETHER THERE ARE ENOUGH EVENTS IN THE CONTROL GROUP AND THE VACCINE GROUP TO BE ABLE TO IDENTIFY A CLEAR-CUT BENEFIT. NOW, IF WE GO TO THE NEXT SLIDE, I JUST WANT -- THIS IS A THANK YOU SLIDE FOR THIS PART OF THE PRESENTATION. I JUST WANT YOU TO SEE HOW MANY DIFFERENT PEOPLE HAVE BEEN INVOLVED IN MAKING THIS EFFORT POSSIBLE. I OF COURSE WANT TO ACKNOWLEDGE THE PEOPLE AT THE FREDERICK SEROLOGY LABORATORY, (INDISCERNIBLE) AND JIM CHERRY. I'D LIKE TO GO TO THE NEXT SLIDE WHICH IS ANOTHER ENDEAVOR WHICH IS VERY RECENT. THIS IS SETTING UP A DATA RESOURCE FOR STRATEGIC ASSESSMENT OF SEROLOGY. IT WILL BE A COVID-19 SEROTRACK. WE ARE SETTING THIS UP WITH THE STRONG COLLABORATION WITH NIAID AND CDC. THE REASON WE'RE DOING IT IS THAT BOTH THE NIAID AND CDC ASKED US IF WE COULD DO IT BECAUSE THEY WERE SO STRAPPED FOR THEIR VARIOUS RESOURCES, AND SO TONY KERLAVAGE AND STEVE HAVE BEEN SETTING THIS UP OVER A VERY REAL PERIOD. NEIL FRIEDMAN FROM NCI WILL BE THE SUBJECT MATTER EXPERT AT NCI, AND THERE WILL BE SUBJECT MATTERS EXPERTS FROM NIAID AND CDC. THE IDEA IS TO COLLECT AND MANAGE COVID-19 SEROLOGIC TEST RESULTS AND SERVE AS RESEARCH RESOURCE TO NCI, NIAID, CDC, AND THE BROADER RESEARCH COMMUNITY. AND THE DASHBOARD, THE GOAL WILL BE TO -- A SUMMARY OF GLOBAL SEROLOGIC STUDIES, ASSAY TYPES AND RESULTS GENERATED AND ANTIBODY PREVALENCE IN THE U.S. WITH THE ABILITY TO FILTER RESULTS BY GEOGRAPHY AND DEMOGRAPHICS. IF YOU LOOK ON THE RIGHT, THE PROTOTYPE WOULD BE IN TWO STAGES, WE HOPE THAT THE SUMMARY DASHBOARD WILL BE ABLE TO BE SET UP SOMETIME THIS SUMMER. AND THE LARGER PROTOTYPE TO BE A A PROTOTYPE TO BE WORKING IN THE FALL, SO STAY TUNED FOR THIS. THE NEXT SLIDE, I WANT TO NOW FOR THE REMAINDER OF THE TIME TALK ABOUT THE PROPOSED SEROLOGICAL SCIENCES NETWORK FOR SARS-COV-2. THE ANNOUNCEMENT FOR THIS NETWORK CAME OUT TEN DAYS AGO. AND THE DUE DATE IS GOING TO BE BY JULY 22. AND I GO OVER THAT IN THE SUBSEQUENT SLIDES. SO THERE WILL BE SEROLOGICAL SCIENCE CAPACITY BUILDING CENTERS, THE GOAL TO EXPAND THE TESTING CAPACITY AND PRACTICE IN THE COMMUNITY, IMPLEMENTING STANDARDIZATION FOR SEROLOGY DEVELOPMENT, AND USING THESE TESTS AND SCALEUP AS NECESSARY FOR TESTING. AND TO ACQUIRE CONVALESCENT SERA FROM RECOVERED PATIENTS WHO ARE SEROPOSITIVE, AND TO CONDUCT SURVEILLANCE TRIALS AND PURSUE FOCUSED SEROLOGICAL SCIENCE. NEXT SLIDE. THERE WILL ALSO BE THE SEROLOGICAL CENTER OF EXCELLENCE, AND THEIR GOALS ARE TO UNDERSTAND MECHANISMS DRIVING SEROLOGICAL HUMORAL RESPONSES TO SARS-COV-2 VIRAL INFECTION AND TO INFORM THE DEVELOPMENT OF NOVEL SEROLOGICAL TESTS, DETERMINE SEROLOGICAL CORRELATES WITH DISEASE PATHOGENESIS AGAINST FUTURE INFECTION AND IMPROVED POPULATION BASED MODELS OF OUTBREAK AND SUSCEPTIBILITY THROUGH SEROLOGICAL-FOCUSED STUDIES. EACH CENTER WILL HAVE SEVERAL PROJECTS AND ADMINISTRATIVE CORE AND POSSIBILITY OF TECHNICAL CORE AND THESE WILL BE U54 AWARDS. THE THIRD COMPONENT WILL BE THE SEROLOGICAL SCIENCE PROJECTS, AND THE GOALS WILL BE TO UNDERSTAND THE MECHANISMS DRIVING THE SEROLOGICAL, HUMORAL AND CELLULAR IMMUNE RESPONSE TO INFECTION, INFORM DEVELOPMENT OF TESTS, DETERMINE SEROLOGICAL CORRELATES, IMPROVE POPULATION BASED MODELS, PREFERENCE FOR CANCER RELEVANT COMPONENT, 5 TO 10 U01 AWARDS, AND UP TO 500,000 COST PER YEAR, AND UP TO FIVE YEARS. THERE WILL BE A NETWORK COODINATING CENTER AT THE FREDERICK NATIONAL LAB DISTINCT FROM THE DASHBOARD I MENTIONED. THE GOALS WILL BE TO PROVIDE PROGRAM MANAGEMENT COORDINATION AND COMMUNICATION ACROSS THE NETWORK. COORDINATION FOR SHARING OF DATA, REAGENTS, SAMPLES, ASSAYS, COORDINATE COMPARISON OF RESULTS AMONG DIFFERENT CENTERS AND ASSAYS, COLLABORATIVE STUDIES LEADING TO INTERNATIONAL SEROLOGICAL STANDARDIZATION. AND TO COORDINATE THE PARTNERSHIPS WITH NATIONAL AND INTERNATIONAL ASSOCIATES SUCH AS FDA, CDC, WORLD HEALTH ORGANIZATION, NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL AND OTHERS, TO WORK IN COLLABORATION WITH THE PROGRAM STAFF. NEXT SLIDE. THERE WAS A REQUEST FOR INFORMATION, RFI, FOR STRATEGY FOR THE CORONAVIRUS TESTING. AND THE -- AND THAT WAS SEEKING INPUT FROM RESEARCH COMMUNITY. IT CLOSED ABOUT THREE WEEKS AGO. AND SOME OF THE RESPONSES ARE BEING INCORPORATED INTO THE SCOPE OF THE NETWORK. AND NOW MY LAST SLIDE PLEASE, WHICH IS REALLY ON THE LEFT TO SUMMARIZE THE HUB AND SPOKE NOTION OF THE SEROLOGICAL SCIENCE NETWORKS, AND IMPORTANTLY TO ACKNOWLEDGE THE MANY PEOPLE WHO HAVE BEEN INSTRUMENTAL IN PUTTING THIS ASPECT TOGETHER, PARTICULARLY I'D LIKE TO ACKNOWLEDGE DINAH SINGER AND CHRISTA WOLFRY AND SARAH HOOK AT NCI, AND AT NIAID CARL DIEFFENBACH, EMILY ERBELDING AND CRISTINA CASSETTI. THANKS FOR YOUR ATTENTION AND I LIKE FORWARD TO YOUR QUESTIONS AND COMMENTS IN THE REMAINING TIME. >> THERE'S AT LEAST ONE QUESTION IN THE CHAT BOX ALREADY. ANNA, I THINK THAT'S YOU. >> HI, YES. THANK YOU, DOUG. THAT'S A LOT OF WORK IN A SHORT CONGRATULATIONS ON THAT. THE QUESTION THOUGH THE RFA, ARE YOU ACTUALLY AIMING TO ATTRACT FOLKS FROM THE -- SCIENTISTS FROM INFECTIOUS DISEASE DISEASE COMMUNITIES OR CANCER RESEARCH WORLD OR BOTH? I'M CURIOUS. >> THIS IS ALL COLLABORATIVE WITH NIAID. AND WE ARE LOOKING TO ATTRACT BOTH GROUPS. AS NED MENTIONED, THERE ARE A LOT OF TALENTED PEOPLE IN THE CANCER RESEARCH COMMUNITY. IF THEY WISH TO APPLY FOR THIS, THAT WOULD BE FINE. BUT THERE ARE ALSO PEOPLE OUTSIDE THE CANCER RESEARCH COMMUNITY WITH TREMENDOUS EXPERTISE IN THIS AREA, AND PERHAPS AT LEAST SOME OF THESE APPLICATIONS WOULD BE A FUSION BETWEEN BOTH GROUPS. >> HAVE THESE BEEN SOLICITED OR ARE THEY GOING TO BE SOLICITED? >> LIZ, THE ANNOUNCEMENT CAME OUT TEN DAYS AGO, AND THEY ARE DUE JULY 22. >> OTHER QUESTIONS FOR DOUG? >> A FOLLOW-UP, LIZ. REMEMBERING THE HIV CRISIS THAT OCCURRED WAY BACK WHEN, WHICH WE'VE -- ACTUALLY NCI -- ARE NOW, QUITE ACTIVELY, AND A NUMBER OF OUR NCI CANCER-SUPPORTED INVESTIGATORS BECAME HIV INVESTIGATORS. I THINK WE SHOULD TRACK AS WE GO INTO THIS SORT OF RELOOK AT, YOU KNOW, INFECTIOUS DISEASE AND CANCER. WE MIGHT WANT TO TRACK HOW MANY OF OUR CANCER RESEARCHERS ARE ACTUALLY MOVING OVER TO FOCUS MORE IN INFECTIOUS DISEASES AS WE THINK ABOUT PANDEMICS IN THE FUTURE. I THINK IT'S AN INTERESTING QUESTION TO SORT OF START LOOKING AT. >> YES, AND I WOULD POINT OUT THAT SAM BRODER REALLY DID A LOT OF THE INITIAL AZT WORK, PARTICULARLY WITH BOB ARCHLIN AND SUBSEQUENTLY BECAME NCI DIRECTOR, WITH A MAJOR INTEREST IN HIV. THAT'S AN INTERESTING QUESTION TO TRACK HOW PEOPLE GO. I SAW THAT THERE WAS A QUESTION, I THINK ABOUT WHETHER MY SLIDES WOULD BE SHARED. OF COURSE. YES, THEY ARE. >> DOUG, THIS IS DAFNA. I HAD A QUESTION ABOUT WHETHER THERE IS ANY EFFORT TO TRY TO GET FROM CANCER CENTERS AROUND THE COUNTRY INFORMATION ABOUT PARALLEL EFFORTS THAT ARE GOING ON TO THIS SEROLOGY INITIATIVE, REALLY BY WAY OF TRYING TO MAKE SURE THAT WE TAKE ADVANTAGE OF WHAT'S GOING ON AS OPPOSED TO HAVING A LOT OF RESOURCES THAT ARE BEING PUT TO UNDERPOWERED STUDIES, THINGS OF THIS NATURE. >> DAFNA, THAT'S A GREAT QUESTION. AND PART OF -- ONE OF THE ADVANTAGES OF OUR WORKING IN THIS CONTEXT WITH NIAID IS THAT WE ARE MADE AWARE OF WHAT IS BEING -- RESEARCH THAT'S GOING ON, WHAT'S BEING SUPPORTED. FOR EXAMPLE, FIVE WEEKS AGO, I WAS INVOLVED IN A WORKSHOP FOR SEROLOGY, IT WAS PUT ON BY NIAID, ACTUALLY DEPARTMENT OF DEFENSE, CDC, AND MARK MULLIVAN FROM NYU MADE A VERY NICE PRESENTATION ABOUT SOME OF THE ONGOING RESEARCH AT NYU. >> THANK YOU. ANY OTHER QUESTIONS FOR DOUG? SOUNDS TERRIFIC. THANK YOU SO MUCH. OUR NEXT PRESENTATION IS FROM JIM DOROSHOW ON NCI-SUPPORTED CLINICAL RESEARCH DURING COVID-19 PANDEMIC. JIM, YOUR TURN. >> THANKS, LIZ, IT'S A PLEASURE TO BE HERE AND TALK TO YOU AND IN PARTICULAR TO UPDATE ALL OF YOU ON ACTIVITIES THAT I OUTLINED, WE'RE ABOUT TO GET STARTED, IN EARLY APRIL. ND TO GIVE YOU SOME IDEAS OF PROGRESS THAT'S BEEN MADE OVER THE LAST SEVERAL WEEKS. SO COULD I HAVE THE NEXT SLIDE PLEASE. BEFORE I GET STARTED I THOUGHT I OUGHT TO UNDERSCORE WHAT YOU KNOW BUT THESE FIGURES THAT WERE IN THE JUNE 2 WASHINGTON POST JUST HIT ME, IT'S HARD TO UNDERSTAND, IF YOU LOOK AT THE DECREASE IN HOSPITAL ADMISSIONS IN THE UPPER LEFT, IF YOU LOOK AT THE LOSS OF REVENUE ACROSS HOSPITALS IN STATE AFTER STATE, IF YOU LOOK AT THE INCREDIBLY DRAMATIC DROP IN PERSONAL HEALTH CARE SPENDING THAT HAPPENED FROM FEBRUARY TO APRIL, PROBABLY WORSE IN MAY, YOU UNDERSTAND THE SITUATION THAT WE'RE IN AS WE TRY TO CONTINUE TO CONDUCT CLINICAL RESEARCH, RESEARCH OF ALL TYPES IN HOSPITALS ACROSS THE COUNTRY. NEXT SLIDE. IF YOU THINK ABOUT THE CHANGES IN HOSPITAL FINANCE, THE DIFFICULTY OF PATIENTS GETTING TO THE HOSPITAL, IT'S NOT DIFFICULT TO PUT TOGETHER A LIST OF IMPEDIMENTS TO CLINICAL CANCER RESEARCH. BY NO MEANS DO I WANT TO IMPLY THAT THIS IS A COMPLETELY -- A LIST THAT ENCOMPASSES EVERYTHING THAT'S GONE ON BUT IT'S REALLY FAIRLY EXTRAORDINARY. IN TERMS OF THE DECREASED EFFICIENCY OF SEEING PATIENTS, THE NEED FOR PPE, LIMITATIONS TO THE VOLUME THAT WE SEE IN OUTPATIENT CLINICS AND LIMITATIONS TO A WHOLE VARIETY OF INPATIENT SOURCES, REPROGRAMMING OF RESEARCH STAFF AND TO COVID-19 RELATED DUTIES, REDUCED ACTIVITIES IN CLINICAL LABS IN TERMS OF THEIR ABILITY TO DO SPECIMENS FOR ROUTINE PATIENT CARE, DECREASES IN AVAILABILITY OF IMAGING, AND INTERVENTIONAL RADIOLOGY SERVICES, CRITICALLY IMPORTANT TO TRANSLATIONAL RESEARCH TRIALS. DRAMATICALLY DECREASED. THERE ARE CLEARLY PRACTICAL IMPEDIMENTS TO HANDLING RESEARCH SPECIMENS. TRAVEL RESTRICTIONS MAKE IT DIFFICULT FOR PEOPLE TO GET TO THEIR VISITS. HAVE HAVE BEEN SIGNIFICANT REPROGRAMMING OR DECREASED STAFFING IN INVESTIGATIONAL DRUG PHARMACIES. AND FOR SURE, SUSPENSION IN LABORATORY UPDATES ACROSS CANCER CENTERS LEAD TO DECREASE IN TRANSLATIONAL RESEARCH LABORATORY ACTIVITIES. LAST BUT NOT LEAST, THE VOLUME OF NOT ONLY COVID-RELATED STUDIES BUT ABILITY OF IRBs TO HANDLE RESEARCH ACTIVITIES RELATED TO CLINICAL CANCER RESEARCH HAS BEEN DIMINISHED. NEXT SLIDE. IT'S REALLY NOT A SURPRISE AT ALL WHEN YOU LOOK AT A SLIDE LIKE THIS, THIS IS FOR THE NCI NCTN TRIALS, BUT THE DROP FROM EARLY MID-MARCH TO THE END OF MARCH AND BEGINNING OF APRIL ACROSS ALL OTHER NETWORKS IS NOT AT ALL DIFFERENT. APPROXIMATELY AT ITS WORST, 45% DECREASE IN ACCRUAL TO INTERVENTIONAL TRIALS, AND EVEN WORSE DECREASE IN ACCRUAL TO SCREENING ACTIVITIES. I DON'T WANT TO SAY THAT THIS IS GOING TO GO ON FOREVER, AND I'M VERY DELIGHTED TO TELL YOU AS THIS MEETING HAS PROGRESSED THIS MORNING, I GOT AN E-MAIL TO TELL ME THAT FOR THE LAST WEEK AND THE WEEK ENDING LAST FRIDAY THAT ACCRUAL TO INTERVENTIONAL TRIAL INCREASED TO 250, WHICH IS THE BIGGEST -- LARGEST NUMBER SINCE EARLY MID-MARCH. SO I HOPE WE'RE ON THE RIGHT TRACK. I CAN'T SWEAR BUT THERE'S SOME OPENING UP IN TERMS OF ACCRUAL TO OUR MAJOR CLINICAL TRIALS NETWORKS, I'M HAPPY TO REPORT. NEXT SLIDE. I'M GOING TO FOCUS FOR THE TIME I HAVE REALLY ON 2 1/2 ITEMS, TALKING ABOUT THE NATURAL HISTORY STUDY THAT NED INTRODUCED, I'M GOING TO TALK ABOUT ALSO THE -- WHAT HE INTRODUCED, THE VERY RECENT RESULTS FROM THE INTRAMURAL PROGRAM ON THE USE OF BBK INHIBITOR TO AMELIORATE SIDE EFFECTS OF COVID-19 INFECTION. I DON'T HAVE TIME TO TALK DID TOCILIZUMAB COMPASSIONATE USE, IT'S NOW CENTRAL IRB APPROVED, WE'RE PLACING THE STUDY ACROSS THE COUNTRY IN SITES WITH DECREASED ACCESS TO IL-6 RECEPTOR ANTIBODY IN UNDERSERVED SETTINGS, PRACTICES AND HOSPITALS. HOPEFULLY I'LL BE ABLE TO GIVE AN UPDATE ON THAT AT A FUTURE MEETING. NEXT SLIDE. LET ME THANK, AT THE BEGINNING, DR. BRIAN BRENNY AND LORESSA FROM NCI, BECAUSE WITHOUT THEM AND A GROUP OF INDIVIDUALS WOULD NOT HAVE GOTTEN THIS OFF THE GROUND. NEXT SLIDE. IT MAKES SENSE IT'S CLEAR WHY WE WAN TO UNDERSTAND IN A LONGITUDINAL WAY WITH APPROPRIATELY INFORMED CONSENT HOW INFECTION WITH COVID-19 IS DISRUPTING CANCER CARE BUT WE'RE ALSO VERY INTERESTED IN THE LONG-TERM OUTCOMES OF PATIENTS WITH COVID-19 AND CANCER. WE HAVE NO IDEA WHAT THE INTERACTION IS BETWEEN MALIGNANCY AND INFECTION. COMORBIDITIES ENHANCE SENSITIVITY TO VIRAL INFECTION AND RISKS, WE KNOW THAT CANCER PATIENTS ARE ADMITTED TO HOSPITALS MORE FREQUENTLY. THEY NEED MECHANICAL VENTILATION MORE FREQUENTLY, IN THE VERY RECENTLY PUBLISHED STUDY FROM VANDERBILT AND CCI-19 CONSORTIUM, 30-DAY MORTALITY WAS A REMARKABLE 13% FOR PATIENTS WITH CANCER. THE GOALS OF THE TRIAL ARE TO ENROLL A LARGE COHORT OF PATIENTS, UNDERGOING CANCER THERAPY, CARE FOR ISOLATE FACTORS ASSOCIATED WITH COVID-19 AND SEVERITY OF CANCER AND INFECTION, UNDERSTAND HOW TREATMENT MODIFICATIONS, WHAT THE IMPACT OF THE VIRUS IS ON TREATMENT AND HOW PATIENTS DO, WHEN THEY HAVE BOTH DISEASES. WE WANT TO UNDERSTAND WHETHER THERE'S SPECIFIC CLINICAL PATHOLOGIC CORRELATIONS IN CERTAIN HISTOLOGIES, AND NOT OTHERS. AND VERY IMPORTANTLY WE WANT TO UNDERSTAND THE DEVELOPMENT OF SARS-COV-2 ANTIBODIES IN PATIENTS WITH CANCER, UNDERSTAND HOW CYTOKINES SECRETION IS ALTERED, GENETIC POLYMORPHISMS ASSOCIATED WITH SEVERE DISEASE AND I THINK I MENTIONED BEFORE TO CREATE A BANK OF CLINICAL DATA, RESEARCH BLOOD SPECIMENS AND RADIOLOGICAL IMAGES, FURTHER UNDERSTAND INTERACTION BETWEEN THE VIRUS AND VARIOUS TYPES OF MALIGNANCY. NEXT SLIDE. I'M HERE TODAY TO TELL YOU THE STUDY IS OPEN, OPEN ACROSS ALL OF THE NCI'S PARTICIPATING SITES, ROUGHLY IT WILL BE OPEN O ROUGHLY 1800 TO 2,000 SITES, THE SITES IN NCTN, EARLY PHASE THERAPEUTIC NETWORK AND COMMUNITY NETWORK, NCCOR. IN THE SCHEMA, IT'S STRAIGHTFORWARD, WE'RE LOOKING TO ACCRUE A THOUSAND PATIENTS, FOLLOW-UP FOR TWO YEARS, BUT WE'RE ALLOWING PATIENTS TO INITIALLY BE SCREENED WHO HAVE CANCER AND ARE BEING TESTED, NOT YET KNOWN TO HAVE INFECTION. THAT ANOTHER NOT -- IF THEY ARE, THEY ARE REGISTERED. SET OF DATA IS COLLECTED, INTENSE AMOUNT COLLECTED IF PATIENTS ARE INPATIENTS WITH COVID-19 WITH CANCER. WHAT ARE THE ISSUES RELATED TO DOING A STUDY LIKE THIS, AS WE'RE ROLLING IT OUT AND HAVING MANY DISCUSSIONS OVER THE MONTH OF MAY, IT BECAME CLEAR WE WANTED TO GET ACCRUAL AND TO OBTAIN THE INFORMATION THAT WAS NECESSARY. WE HAD TO HAVE A STUDY THAT WAS FEASIBLE TO DO IN THE CONTEXT OF THE COVID-19 PANDEMIC. SO AS I DISCUSSED PREVIOUSLY, IN TERMS OF THE CHANGES IN THE CLINICAL TRIAL PROCESS THAT NCI HAS INTRODUCED FOR THIS STUDY IN PARTICULAR CONSENT CAN BE DONE REMOTELY. WE'VE SPECIFICALLY MADE IT MANDATORY THAT NO EXTRA VISITS OR BLOOD TESTING OR CLINICAL EVALUATION ARE DONE OUTSIDE OF WHAT IS NECESSARY, FOR ROUTINE CLINICAL CARE. RESEARCH BLOOD SPECIMENS WILL BE COLLECTED AT THE SAME TIME AS ROUTINE BLOOD DRAWS, IMAGING DONE ONLY BASED ON SCANS THAT ARE NEEDED FOR THE FOLLOW-UP FOR PATIENTS MALIGNANCY. WE ALSO INITIALLY, YOU'LL SEE THIS WILL CHANGE OVER TIME, INITIALLY THE RESEARCH BLOOD TESTS DRAWN WERE DEVISED SUCH A WAY AS TO NOT REQUIRE ON-SITE PROCESSING WE KNEW THIS WAS GOING TO BE OPEN, MANY SITES, IT WASN'T CLEAR INITIALLY WHETHER OR NOT EVEN SPECIAL KITS WILL BE PROVIDED WHETHER ALL SITES COULD DO WHAT IS NECESSARY FOR TESTS WE WOULD HAVE LIKED TO INITIALLY STARTED WITH. YOU'LL SEE THAT'S CHANGED. AND THEN CLEARLY, VERY IMPORTANTLY, ALL OF THE SITES ACROSS THE UNITED STATES SUPPORTED BY THE NCI PARTICIPATE IN THIS STUDY WILL BE FULLY REIMBURSED BASED ON REQUIREMENTS OF ETC CN GRANT, NCORP OR NCTN. WE PUT FORWARD AND OPENED THE STUDY, IT'S OPEN NOW, WE HOPE IN A MONTH WE'LL HAVE AMENDMENT ONE REVIEWED BY THE FEDERAL IRB, OPEN ENROLLMENT TO PEDIATRIC PATIENTS, ALSO WE HAVE A WORKING GROUP WORKING ON QUALITY OF LIFE ASSESSMENT, FOR OUTPATIENTS, SO THAT'S GOING TO BE INCORPORATED. DEB, I'LL MAKE SURE OUR COLLEAGUES IN DCCPS WILL CONTACT YOU TO MAKE SURE THE DATA WILL BE REQUIRED IN THIS AMENDMENT, APPROPRIATE FROM YOUR PERSPECTIVE. WE'RE ALSO WORKING WITH A WORKING GROUP FOR IMAGING ANALYSIS, THEY ARE CONTRIBUTING TO THIS AMENDMENT SO WE UNDERSTAND WHAT KIND OF DATA AND HOW THAT WILL BE HOUSED AND QC'ed, DEFINED IN THE FIRST AMENDMENT. SECOND AMENDMENT HAS RECENTLY BEEN AGREED UPON, AND THIS WILL ALLOW FOR AND SPECIFY ADDITIONAL BLOOD COLLECTIONS FOR SITES TO HAVE ON-SITE PROCESSING CAPABILITIES. WE WEREN'T SURE THIS WAS GOING TO BE POSSIBLE BUT TWO WEEKS AGO WE GOT RESULTS OF A SURVEY WE DID ACROSS THE ENTIRE NCI CLINICAL TRIALS NETWORK, TURNS OUT APPROXIMATELY 85% OF ALL SITES ARE FULLY CAPABLE OF DOING CERTIFICATION NECESSARY TO COLLECT SERUM TUBES FROM NEUTRALIZING ANTIBODY STUDIES AND COAGULATION ASSAYS THAT ARE IMPORTANT IN PARTS OF THIS TRIAL, WE'RE ENCOURAGED AND THAT WILL BE THE SUBJECT OF AMENDMENT 2. FINALLY NCCAPS STUDY, UP TO 450 SITES REGISTERED, FROM THE IMAGINATION STAGE ON APRIL 1 TO BEING ACTIVATED ON MAY 21. WE'VE HAD OUR FIRST PATIENTS ENROLLED AND WE'RE GRATEFUL TO SITES AROUND THE COUNTRY RAPIDLY DECIDED THEY WANTED TO PARTICIPATE IN THIS INVESTIGATION. NEXT SLIDE. I'M GOING TO MOVE TO A FEW SLIDES ABOUT A VERY IMPORTANT STUDY THAT WAS PUBLISHED TEN DAYS AGO IN SCIENCE IMMUNOLOGY, DEVISED IN LARGE MAYBE BY LOU STOUT AND THE INTRAMURAL PROGRAM, CARRIED OUT AT A VARIETY OF SITES, WITH ASSISTANCE AND STRONG SUPPORT OF ASTRA ZENECA TO USE ABRUTINIB. PART OF PATHOPHYSIOLOGY IN THE LUNG NATIVATION THROUGH A VARIETY OF PATHWAYS, INFLAMMASOME NF-kappaB MEDIATED PATHWAYS TO ACTIVATE SECRETION OF WIDE VARIETY OF PRO-INFLAMMATORY CYTOKINES VERY DAMAGING TO THE LUNG AND TO THE IMMUNE SYSTEM. AND SO THE IDEA, ACALABRUTINIB WHETHER ITS COULD BE USED IN PATIENTS WITH SIGNIFICANT DISEASE TO INTERFERE WITH DEVELOPMENT OF HYPERINFLAMMATORY PATHOPHYSIOLOGY. NEXT SLIDE. HYPOTHESIS WAS BLOCKING IMMUNE SYSTEM WOULD REDUCE NEED FOR MECHANICAL VENTILATION, AND DECREASE THE SEVERE PULMONARY INJURY LEADING TO DEATH BUT OBJECTIVE AS WELL OF COURSE TO UNDERSTAND WHETHER THIS ANTI-CANCER DRUG COULD BE USED SAFELY IN THE CONTEXT OF THE ADDITION TO BEST SUPPORTIVE CARE IN PATIENTS WITH SEVERE COVID-19 INFECTION. ENDPOINTS WERE ACTUALLY PRETTY HIGH BAR ENDPOINTS, THAT IS TO SAY NEED FOR MECHANICAL VENTILATION OR DEATH, AND OVERALL SAFETY PROFILE. PATIENTS WERE ELIGIBLE FOR THE STUDY IF THEY HAD EVIDENCE OF SEVERE INFLAMMATION, VERY HIGH CRP, AND DECREASED OXYGEN SATURATION AT THE OUTSET. NEXT SLIDE. THIS REPORTS IN SCIENCE IMMUNOLOGY INVOLVED 19 PATIENTS, TAKEN FROM AROUND THE COUNTRY, WALTER REED AND SITES AROUND THE COUNTRY THAT INVOLVED STANDARD DOSE REGIMEN OF ACALABRUTINIB, MONITORING OF FIO2 AND INFLAMMATORY MARKERS WITH BIOMARKER ASSESSMENTS AS WELL. THE MOST DRAMATIC, AMONGST THE MOST DRAMATIC WAYS TO UNDERSTAND WHAT HAPPENED TO THESE PATIENTS IS LOOK AT THE TIME COURSE OF BOTH OXYGEN SATURATION FOR THESE PATIENTS, AS WELL AS CRPs, LYMPHOCYTE COUNTS AND INTRODUCTION OF ACALABRUTINIB. WITHIN A MATTER OF A FEW DAYS BOTH PATIENTS SHOWED DRAMATIC DECREASE IN C-REACTIVE PROTEIN, CONCOMITANT WITH INCREASE IN BLOOD SATURATION. WHAT YOU FOUND REPORTED IN 9 OF 11 PATIENTS NEED FOR SUPPLEMENTAL OXYGEN WAS SIGNIFICANTLY DECREASED, 4 OF 8 EXTUBATED, WITH ACALABRUTINIB, DECREASED IN PRO-INFLAMMATORY BIOMARKERS SUGGESTING HYPOTHESIS THAT WAS THE BASIS WAS IN FACT AT LEAST FROM THIS INITIAL PILOT STUDY VALIDATED. NEXT SLIDE. I WOULD LIKE TO END MY TALK AND TAKE QUESTIONS, BUT FIRST THANK MY COLLEAGUES FROM ACROSS ESSENTIALLY EVERY DIVISION OF THE NCI AS WELL AS COLLEAGUES AT VANDERBILT AND OHIO STATE, AND ASTRA ZENECA WHO MADE THESE STUDIES POSSIBLE, AND WE HOPE THAT OVER TIME WE'LL DEVELOP THE KIND OF DATA TO HELP US UNDERSTAND AND INTERACT WITH CANCER PATIENTS SO I'M HAPPY TO TAKE QUESTIONS. >> THANK YOU, JIM. OUR FIRST QUESTION FROM ANDREA HAYES JORDAN. >> I'M EXCITED TO SEE INCLUSION OF PEDIATRIC PATIENTS IN AMENDMENT 1. WE REALLY WOULD ENCOURAGE EVERYONE INVOLVED IN THAT INVESTIGATION TO BE VERY INCLUSIVE, ALL AGENTS OF PEDIATRIC PATIENTS AND SYMPTOMATOLOGY WE'RE SEEING IS DIFFERENT IN PEDIATRIC CANCER PATIENTS, ONE OF THE FIRST SYMPTOMS SEEMS TO BE, THIS MAY BE JUST SOME PATIENTS WE'VE SEEN, BUT LOSS OF SMELL AND TASTE AS OPPOSED TO PULMONARY SYMPTOMS, AND IN THE NON-CANCER PATIENTS WITH COVID-19 WE'RE SEEING NEUROLOGIC SYMPTOMS SUCH AS BRAIN HERNIATION AND RESPIRATORY SYMPTOMS OCCURRING LATER. AS THESE NEW DRUGS ARE BEING TESTED, AS THESE PROTOCOLS ARE BEING ROLLED OUT, I WOULD ENCOURAGE NOT TO LIMIT TO LOOKING AT PATIENTS WITH RESPIRATORY SYMPTOMS, CHILDREN, ALSO GOING ALL THE WAY DOWN TO LITERALLY THE NEWBORNS AND THE INFANTS WITH ALL THIS TESTING. I THINK THAT WOULD REALLY EXPAND OUR KNOWLEDGE. >> GREAT. THANK YOU. >> QUESTION YOU DESCRIBE THE DESIGN OF THE BIOMARKER STOMACHY IT SEEMED THAT IF THEY TESTED NEGATIVE THEY WERE ALL STUDIED, WHAT PERCENTAGE DO YOU EXPECT TO BE FALSE NEGATIVE? >> I THINK RELATIVELY SMALL. THERE'S A LOT OF DISCUSSION A SMALL LINE ON THE BOTTOM, I SHOULD HAVE MADE IT CLEAR WE'RE LOOKING FOR PATIENTS WHO ARE COVID-19 POSITIVE WITHIN 14 DAYS OF STARTING ON THE TRIAL. THE IDEA BEING WE WANT TO UNDERSTAND FULL INTERACTION, SO FOR PATIENTS WHO WERE COVID-19 POSITIVE MONTHS PREVIOUSLY I'M NOT SURE THAT WOULD MEET GOALS OF THE INVESTIGATION. >> OKAY, GREAT. JUST CURIOUS. IT LOOKED LIKE YOU WERE TESTING EVERYBODY AT THE SAME PLACE SO IT'S THE SAME ASSAY THAT'S BEING USED, IS THAT CORRECT? >> IT BASICALLY HAS TO BE AN FDA-APPROVED CLIA-CERTIFIED. >> THANK YOU. LOOKS LIKE THERE'S ANOTHER -- KEVIN HAS A QUESTION. >> YEAH, JIM, THIS IS KEVIN. THAT WAS REALLY INTERESTING PRESENTATION. I HAVE A QUESTION FOR YOU, MAYBE GETTING TOO DEEPLY IN THE WEEDS, BUT YOU MENTIONED VERY HIGH MORTALITY RATE IN CANCER PATIENTS WITH COVID-19, 13% FROM VANDERBILT STUDY, AND AT THE END SHOWED THIS BEAUTIFUL HYPERINFLAMMATORY SORT OF INTERVENTION FROM LOU STOUT. AND I'M WONDERING IF THOSE TWO THINGS ARE -- I DISCONNECTED IN SOME WAY, YOU WOULD EXPECT PERHAPS LESS OF AN IMMUNE RESPONSE IN CANCER POPULATION. SO DO YOU SEE DIFFERENT FORMS OF COVID-19, ONE THAT AFFECTS IMMUNOSUPPRESSED PATIENTS THAT DON'T MOUNT MUCH OF IMMUNE RESPONSE AND ANOTHER VARIANT OF IMMUNOCOMPETENT PATIENTS WHO OVERSHOOT AND GET SICK BECAUSE OF HYPERIMMUNE RESPONSE, IS THERE ANYTHING YOU'VE BEEN ABLE TO SEE ABOUT THAT, THAT SUGGESTS SOMETHING ALONG THOSE LINES WHERE YOU MAY NEED TO USE A BIOMARKER LIKE CRP TO SEE WHO WOULD BENEFIT FROM SORT OF SUPPRESSING THE IMMUNE RESPONSE? >> THAT'S A GREAT QUESTION. I REALLY DON'T KNOW THE ANSWER. THERE ARE JUST RECENTLY DESCRIBED MUTATIONS IN COVID-19 THAT MAY HELP TO EXPLAIN OR MAY NOT, THERE MAY BE VARIANTS THAT DIFFERENT POPULATIONS AS I THINK I MENTIONED LAST TIME, STEVE JANIK IS DOING GWAS STUDIES, WE DON'T KNOW IF THERE ARE GENETIC VARIANTS THAT AFFECT CLINICAL MANIFESTATIONS IN PATIENTS AT DIFFERENT AGES, ETHNICITIES, ET CETERA. THAT'S ONE OF THE MAIN THINGS I HOPE THIS NATURAL HISTORY STUDY WILL DEFINE, HOPEFULLY WILL BE LARGE ENOUGH TO LOOK AT A WIDE VARIETY OF AGES, ETHNIC BACKGROUNDS, GENETIC BACKGROUNDS TO BE ABLE TO UNDERSTAND SOME OF THE POINTS THAT YOU JUST MADE. >> ANNA BARKER HAS A QUESTION. >> HI, JIM. REALLY INTERESTING STUDY. SINCE WE KNOW THIS PARTICULAR VIRUS MORTALITY SKEWS TO AGED POPULATION AND COMORBIDITIES SOMETIMES THE COMBINATION OF BOTH DID YOU SEE REAL DIFFERENCES IN TERMS OF OXYGEN SATURATION, FOR EXAMPLE IN THE OLDER PATIENTS OR THOSE A BIT SICKER AND DID IT CORRELATE WITH BIOMARKER STUDIES, ESPECIALLY IMMUNOLOGIC PROFILES? >> SO FIRST, I WANT TO MAKE SURE THAT IT'S CLEAR THAT THE BEAUTIFUL STUDY THAT LOU AND WYNDHAM REPORTED WAS THEIR STUDY, NOT MINE. I WANT TO MAKE THAT ABSOLUTELY CLEAR, AND THEIR IDEAS. I THINK THAT TO GET INTO THE STUDY YOU HAVE TO HAVE DIMINISHED IO, WHICH MAKES IT MORE DRAMATIC THESE WERE CIRCUMSTANCE PATIENTS WITH LOW FIO2, ON A VENTILATOR, I DON'T KNOW THE ANSWER BUT THERE'S SOME SUBCATEGORY OF PATIENTS WHO GET THIS DISEASE THAT REALLY HAVE A HYPERIMMUNE STATE THAT ONE WITH INTERVENE WITH, BUT EXACTLY WHAT PERCENTAGE OF THOSE PATIENTS ARE AND WHAT THEIR DEMOGRAPHICS MIGHT BE, I DON'T THINK THE SAMPLE SIZE IS LARGE ENOUGH. >> THANK YOU. VERY INTERESTING STUDY. >> ANY OTHER QUESTIONS FOR JIM? THANK YOU SO MUCH. REALLY INTERESTING. APPRECIATE IT, JIM. OKAY. OUR LAST PRESENTATION THIS MORNING IS ON MINORITY ACCRUAL TO NCTN AND CLINICAL TRIALS, DR. MCCASKILL-STEVENS, DIVISION OF CANCER PREVENTION, WILL BE PRESENTING TODAY. WORTA? >> THANK YOU VERY MUCH. I'M GOING TO PRESENT TODAY ACCRUAL OF MINORITIES IN THE NCTN AND NCORP CLINICAL TRIALS, A 20-YEAR VIEW. NEXT SLIDE PLEASE. THE SCIENTIFIC EVIDENCE GAINED FROM CLINICAL TRIALS PROVIDES THE MOST IMPORTANT AND RELIABLE INFORMATION FROM EFFECTIVE CARE AND MANAGEMENT OF CANCER PATIENTS AS WELL AS THOSE INDIVIDUALS AT RISK OF DEVELOPING CANCER. FOR THESE REASONS THE TRIALS MUST PROVIDE EVIDENCE THAT'S VALID AND GENERALIZABLE TO ALL POPULATIONS, HENCE FREQUENT INTEREST AND FREQUENT QUESTIONS WHO PARTICIPATES AT NCI CLINICAL TRIALS. INDIVIDUALS OF DIVERSE POPULATIONS NEED ACCESS, THESE TWO NETWORKS PROVIDE ACCESS FOR PATIENTS TO EMBARK UPON A JOURNEY TO CLINICAL TRIALS FOR IMPROVED OUTCOMES FOR THEMSELVES AS WELL AS OTHERS. AND FINALLY, DIVERSE ENROLLMENT IS A MAJOR AIM OF MANY NATIONAL RESEARCH POLICIES. NEXT SLIDE. TODAY'S DISCUSSION WILL INCLUDE ACCRUALS FROM 1999 TO 2019, AS REPORTED USING OFFICE OF MANAGEMENT AND BUDGET CATEGORIES. MINORITY ACCRUAL IN NEWER GENERATIONS OF TRIALS ARE INCLUDED, ALLOWS US TO LOOK AT THE TRIALS COMPLETED, CURRENT TRIALS HOW WE SHOULD LOOK AT UNDERREPRESENTATION FOR FUTURE TRIALS. NEXT SLIDE. WE USE THE CANCER THERAPY EVALUATION PROGRAM ENTERPRISE SYSTEM, LOOKED AT GROUPS FROM 1999, REORGANIZATION INTO NCTN AND COMMUNITY CLINICAL ONCOLOGY PROGRAM AND ORGANIZATION AND TRANSITION TO NCORP, LOOKING AT THREE YEAR INTERVALS AND FOR SUBSETS OF MINORITIES, SPECIFICALLY AFRICAN AMERICAN AND HISPANICS. NEXT SLIDE. SO WE FIRST LOOKED AT ALL PHASES OF TRIALS, AS YOU CAN SEE IN THE ENCIRCLED NUMBER, 355,000 ENROLLED OVER THIS TIME PERIOD. OF THOSE, 122,000 MET CRITERIA FOR RACIAL AND ETHNIC MINORITIES. WE STARTED IN 1999, SOMEWHAT ARBITRARILY, BUT IT'S SIX YEARS AFTER THE NIH REVITALIZATION ACT, AND THIS MANDATED INCLUSION OF WOMEN AND MINORITIES IN CLINICAL TRIALS. THIS IS IMPORTANT BECAUSE INSTITUTIONS THINK ABOUT HOW THEY WOULD GO TO COLLECT DATA TO ALLOW INTERVENTION SO PATIENTS COULD SELF REPORT ACCURACY OF THIS INFORMATION. YOU CAN SEE PERCENTAGE OF MINORITY ENROLLMENT OVER TIME IS 19%. YOU CAN SEE THAT THERE HAVE BEEN INCREASES. THERE ARE VARIATIONS THAT VARY DEPENDING UPON AVAILABILITY OF TRIALS. INCLUDED OVER THE YEARS WAS LARGE ADJUVANT TRIAL IN BREAST AND BOWEL IN PARTICULAR, TWO LARGE PREVENTION TRIALS FOR BREAST AND PROSTATE THAT AFFECT SOME VARIATIONS THAT YOU MAY SEE. WE HAD BEGUN ABOUT THIS PERIOD OF TIME, THE MID-20s, TO INFORM INVESTIGATORS THAT WE WERE GOING TO UTILIZE NEW TECHNOLOGY AND MOLECULAR CHARACTERIZED TRIALS AND WILL BE LESS ADJUVANT TRIALS. TAILOR X BEGAN IN TWIEKS FOR ITS APPROVAL. YOU CAN SEE AS WE GET CLOSER TO THE LAST OR THREE YEAR INTERVALS WE HAVE DECREASE THAT REFLECTS THAT TRANSITION TO NEW GENERATION OF TRIALS. WE EFFECT USED ON SUBSET OF AFRICAN AMERICANS, 50,000 ENROLLED. THEY MIRRORED ENROLLMENT OVERALL FOR CLINICAL TRIALS, AND THE TOTAL ACCRUAL IS 9%, BUT AS YOU LOOK THROUGH THE YEARS, 8%, LAST THREE YEARS, 11%. NEXT SLIDE PLEASE. WE LOOKED AT AGE, INTERESTED IN THE PEDIATRIC POPULATION, AS WELL AS THE INTEREST IN ADOLESCENCE AND YOUNG ADULTS, BETWEEN 15 AND 39. WE CAN NOTE FOR AFRICAN AMERICANS MAJORITY OF PATIENTS IN THE AGE GROUP OF 40 TO 69, VERY CONCERNED ABOUT THE UNDERREPRESENTATION OF MINORITIES AND ELDERLY PATIENTS PAYING CLOSE ATTENTION TO COMORBIDITIES WE KNOW ARE SEEN IN THESE POPULATIONS. WE CAN SEE IF YOU COMBINE YOUNGER CHILDREN AND ADOLESCENCE, PERCENTAGES IS 19%, AFRICAN AMERICAN DOES NOT HAVE THE HIGHEST DISTRIBUTION OF YOUNGER POPULATIONS WITHIN THAT GROUP. WE FOCUSED ON ENROLLMENT OF HISPANICS OR LATINOS, BEGINNING FROM 1999 AS WE TRAVERSE, WE DOUBLE THE ENROLLMENT, OVER 43,000 INDIVIDUALS ENROLLED IN CLINICAL TRIALS. OF NOTE WHEN WE LOOK AT YOUNGER POPULATION WE CAN SEE THAT HISPANIC VERSUS YOUNGER WAS A THIRD OR 18% BETWEEN THE AGES OF 1 TO 18, AND ANOTHER THIRD, 15 MILLION, BETWEEN 18 AND 33. IN CONTRAST TO WHAT WE SAW IN THE AFRICAN AMERICAN PERCENTAGE IF YOU COMBINE THE YOUNGER CHILDREN, NEXT SLIDE PLEASE, IF YOU COMBINE THE YOUNGER CHILDREN WITH HE ADOLESCENTS AND YOUNG ADULTS YOU HAVE 19% SEEN IN THE AFRICAN AMERICANS. SO THIS POPULATION IS MUCH YOUNGER, IF ONE-RUN WERE TO ASK, WELL, WHAT'S THE PERCENTAGE OF CANCERS IN THIS GROUP PRETTY MUCH DRIVEN BY LEUKEMIA, HISPANIC POPULATION HAS THE HIGHEST PERCENT OF LEUKEMIA AMONG YOUNGER POPULATION. SO WE LOOKED AT 2018 AND IT WAS REPORTED AND ESTIMATED THAT ABOUT 2700 PATIENTS WOULD BE DIAGNOSED WITH CANCER IN THE 0 TO 14 GROUP SO DEPENDING UPON AVAILABILITY OF LEUKEMIA TRIALS WE'RE CLOSELY MATCHING THAT AGE RANGE. NEXT SLIDE PLEASE. WE LOOKED AT PHASE 3 TRIALS, REPRESENTING 87% OF THE TOTAL PHASES. WE CAN SEE OVER 500,000 PATIENTS WERE ENROLLED. I WANTED TO DIRECT YOUR ATTENTION TO THE MINORITY ENROLLMENT. IF YOU FOCUS ON PHASE 3 TRIALS IN THE LAST THREE YEARS, WE'RE UP TO 27%. NOT SHOWN HERE ARE PHASE 2 TRIALS, WE DID NOT INCLUDE THEM BECAUSE WE DID NOT OBSERVE SIGNIFICANT DIFFERENCES IN THE TREND OF ENROLLMENT OF RACIAL AND ETHNIC MINORITIES. NEXT SLIDE PLEASE. WE THEN LOOKED AT THE OTHER FOUR CATEGORIES IN THE OMB CRITERION, AND THE OVERALL ASIAN ENROLLMENT IS ABOUT 3%, SO LESS THAN WHAT WE'RE SEEING THROUGHOUT THE U.S. COUNTRY. CERTAINLY FOR AMERICAN INDIANS AS WELL AS ALASKA NATIVE I S AND HAWAIIAN ISLANDERS, LESS THAN 1%, WE HAVEN'T SEEN SIGNIFICANT TRENDS BUT THERE ARE SIGNIFICANT EFFORTS TO ENGAGE THESE POPULATIONS BY VARIOUS INITIATIVES. NEXT SLIDE. WE ASKED THE QUESTION, WHAT DO WE SEE IN TERMS OF ENROLLMENT FROM THE COMMUNITY SETTING AND THE ACADEMIC SETTING. SO WHAT YOU SEE HERE AND WE JUST STARTED INFECTION OF NCORP IN 2014, LOOKED AT SIMILAR TIME POINTS FOR NCTN GROUP. YOU SEE TOTAL OF 23,000 ENROLLMENTS FOR THE NCORP, 90,000 FROM THE NCTN. THE OVERALL CONTRIBUTION BEING 26%, MINORITY 27%, PLEASE NOTE NCORP PROGRAM HAS A SPECIFIC COMPONENT DEDICATED TO MINORITY UNDERSERVED POPULATIONS TO WHICH THE ENROLLMENT FOR RACIAL AND ETHNIC MINORITY IS 55%. WE INCLUDED SCIENCE OF CANCER CARE DELIVERY RESEARCH, THE GOAL TO IMPROVE CLINTON OUTCOMES BY INTERVENING ON PATIENTS, CLINICIANS AND ORGANIZATIONS. FACTORS INFLUENCED DELIVERY OF CARE, IMPORTANT INSIGHT AS TO OTHER AREAS THAT MIGHT INFLUENCE ENROLLMENT OF UNDERSERVED POPULATIONS. SPECIFICALLY IN THE ORGANIZATION. 6900 PATIENTS WERE ENROLLED, 26% MINORITIES, RARELY AND ETHNICITY MINORITIES, 60% OF THAT CAME FROM THE MINORITY UNDERSERVED NCORP. NEXT SLIDE. THIS WAS A PICTURE TAKEN FROM AN ARTICLE PUBLISHED IN THE "NEW YORK TIMES" IN 2016, ABOUT THE TIME THERE WAS TREMENDOUS EXCITEMENT ABOUT IMMUNOTHERAPY. ESSENTIALLY THE ARTICLE STATES PARTICIPANTS WERE OVERWHELMINGLY WHITE. WE TOOK A SNAPSHOT, FROZEN IN TIME, TWO SLIDES WITH ENOUGH TARGETED THERAPIES AND THOUGHT WE COULD PRESENT THE FIRST TRIAL, ONE THAT UTILIZED IMMUNOTHERAPY DEVELOPMENT IN THE PERIOPERATIVE SETTING, PATIENTS WILLING TO UNDERGO NEPHRECTOMY FOR RENAL CARCINOMA. YOU SEE 20% OVERALL MINORITY ACCRUAL. WE THOUGHT IN THE CONTEXT OF THE PARTICIPATION IN THE CLINICAL TRIALS THAT GIVE THE DRUG APPROVAL. FOR EACH OF THE CATEGORIES AT THIS PARTICULAR TIME, THE MINORITY REPRESENTATION FOR ALL GROUPS EXCEEDS THAT OF THE REPRESENTATION AT THE TIME OF FDA APPROVAL, AND WITH THE EXCEPTION OF ASIAN POPULATIONS BECAUSE THAT POPULATION HAD THE HIGHEST NUMBER OF MINORITIES IN THE FDA APPROVAL CLINICAL TRIALS. THE SECOND TRIAL WE WANTED TO BRING TO YOUR ATTENTION WAS A TRIAL THAT WAS USING IN THE ADJUVANT SETTING WITH TRIPLE-NEGATIVE, PATIENTS WERE RANDOMIZED AFTER RECEIVING NEOADJUVANT THERAPY, MINORITY ENROLLMENT 28%. LOOKING AT POPULATIONS WITH TRIPLE-NEGATIVE, BLACKS AND HISPANICS, THEY EXCEEDED ENROLLMENT INTO FDA APPROVAL TRIALS BUT IN ADDITION THIS EXCEEDS -- ABOUT EQUAL TO AFRICAN AMERICAN POPULATION, IMPORTANTLY CONSISTENT WITH THE INCIDENCE OF TRIPLE-NEGATIVE BREAST CANCER IN THE AFRICAN AMERICAN POPULATIONS, SIMILARLY FOR HISPANICS. NEXT SLIDE. MOVING FORWARD, PUSH THE BUTTON FOR ME. OKAY. ONE OF THE IMPETUS FOR HAVING THESE DATA PRESENTED TO YOU WAS THE QUESTION REGARDING DISAGGREGATION WITHIN RACE AND ETHNICITY, WHICH IS A VERY IMPORTANT ONE. CURRENTLY WE HAVE BEGUN TO SEE IMPORTANCE ON AFRICAN AMERICAN, WHETHER THEY COME FROM THE CARIBBEAN, SUBSAHARA IN AFRICA. WE'RE GOING TO BEGIN TO LOOK AT THIS IN THE HISPANIC POPULATION, INCREDIBLY IMPORTANT, INCREASING IN THE COUNTRY AND ESTIMATED INCREASES OVER TIME. WE HAVE FOCUSED OUR ATTENTION ON LANGUAGE, ALSO VERY INTERESTED IN THE COUNTRY OF ORIGIN, NOT ONLY FOR THE NUANCES OF LANGUAGE AND CULTURE BUT WE WANT TO HAVE WAYS OF INFORMED STRATEGIES FOR ENROLLING, FOR EXAMPLE, WHETHER THAT INDIVIDUAL COMES FROM A COUNTRY THAT HAS HAD A REGISTRY, HAS HAD ACCESS TO CLINICAL TRIALS, EXISTENCE OF CLINICAL TRIALS TO BETTER UNDERSTAND WAYS TO OVERCOME BARRIERS FROM THOSE AREAS. NEXT PLEASE. WE HAVE IMPLEMENTED A CLINICAL TRIAL LOG FOR PEDIATRICS AS WELL AS ADULTS, WITH THE GOAL TO EXPAND DEMOGRAPHIC COLLECTION OF INFORMATION INCLUDING EDUCATION, SOCIOECONOMIC FACTORS, BARRIERS, COMORBIDITIES TO HELP US IN TRIAL DESIGN AS WE THINK ABOUT THAT INFORMATION. NEXT PLEASE. WE HAD CONSENSUS WHEN WE BEGAN TO ENROLL PATIENTS IN TISSUE ACQUISITION, MOST STUDYING ADVANCED DISEASE AND PROVIDING INFORMATION TO TREATMENT TRIALS. WE HAD NOT IN THE PAST PROVIDED ACCRUALS, WE'RE CURRENTLY DOING THAT AT THIS TIME, MOVING FORWARD, TO MONITOR THE PARTICIPATION OF THESE POPULATIONS THAT ARE VERY, VERY IMPORTANT AS WE THINK THIS IS THE DIRECTION WE'RE GOING TO BE GOING WITH OUR CLINICAL RESEARCH. NEXT PLEASE. QUALITY OF LIFE STUDY EXPERTISE WITHIN THE NCORP AS WELL AS REVIEW. WE HAVE A NUMBER OF QUALITY OF LIFE STUDIES EMBEDDED IN TREATMENT TRIALS AND QUALITY OF LIFE POPULATIONS WITH SIGNIFICANT OBESITY AND OTHER CHRONIC DISEASES IS VERY IMPORTANT, SO ACCRUAL ALSO IS BEING MONITORED AND GIVEN TO THE SITES FOR PARTICIPATION. NEXT SLIDE. AND FOR THOSE IMPORTANT TOOLS THAT ARE INCLUDED IN QUALITY OF LIFE ACCRUALS, WE HAVE FOUND MANY TOOLS ARE NOT TRANSLATED IN POPULATIONS TO LANGUAGES THAT WILL BE INCLUSIVE FOR POPULATIONS. WE HAVE MOONSHOT FUNDING TO LOOK AND VALIDATE TOOLS FOR VARIOUS LANGUAGES BUT THAT'S LED BY DIANE AND THE NCORP GROUP AND FINALLY WE HAVE EXPERTISE AND INTEREST ACROSS THE USER SPACE TO LOOK AT OTHER GROUPS FOR UNDERREPRESENTATION INCLUDING ELDERLY, AND RURAL POPULATIONS NOW IDENTIFIED AS POPULATION ELIGIBLE TO PARTICIPATION . I THANK YOU FOR YOUR ATTENTION AND I'M HAPPY TO ANSWER QUESTIONS. >> WE HAVE ONE QUESTION. >> WORTA, LET'S SEE. I VERY MUCH APPLAUD YOUR EFFORTS AND WHAT YOU'VE BEEN DOING. PARTICULARLY YOUR EFFORTS TO AGGREGATE WITHIN RACE AND ETHNICITY. ONE QUESTION THAT I HAVE IS ARE YOU INCLUDING GENETIC ADMIXTURE STUDIES? >> IN STUDIES FOCUSED ON RACIAL AND ETHNIC POPULATIONS WE ARE DOING THAT, IN PARTICULAR I THINK ABOUT A STUDY LOOKING AT PERIPHERAL NEUROPATHY, ASSOCIATED WITH DIABETES OF COURSE, PREVALENT IN AFRICAN AMERICANS, WITHIN THAT STUDY WE'RE USING THOSE PLATFORMS, AS AN EXAMPLE. >> THANK YOU. >> OTHER QUESTIONS? I SEE KAREN -- SHE APPLAUDS YOU. >> HI. THANKS, LIZ AND WORTA. MY QUESTION HAS TO DO WITH TRYING TO UNDERSTAND IF WE SHOULD -- HOW MUCH MORE WORK WE HAVE TO DO. SO IN THE FIRST THREE-YEAR PERIOD AFRICAN AMERICAN ENROLLMENT WAS 8%, NOW IT'S GONE TO 11%. HOW DOES THAT COMPARE TO THE COMMUNITY FROM WHICH THESE PATIENTS ARE DRAWN, SOME COMMUNITIES HAVE A MUCH HIGHER PERCENTAGE OF AFRICAN AMERICANS AND THOSE NUMBERS SEEM LOW. SO IS THERE A WAY TO SORT THAT OUT? >> WELL, I THINK, YOU KNOW, WE HAVEN'T COME TO WHETHER THERE SHOULD BE THE METHOD SHOULD BE MULTI-FACTORIAL. ARE WE PROVIDING ACCESS IN AREAS WITH THE HIGHEST CONCENTRATION, AND WE HAVE SUCH A PROGRAM. IT'S NOT -- DOESN'T A -- WE COVER ALL THE STATES BUT DO WE COVER EVERY AREA WHERE WE HAVE THE HIGHEST CONCENTRATIONS, WE DO NOT. AND I THINK THERE'S WORK IN THAT AREA BUT I THINK ALSO TRIALS ARE VERY SPECIFIC. I THINK THAT WE HAVE TO THINK ABOUT IN DESIGNING OUR TRIALS, YOU KNOW, WHERE THE POPULATIONS THAT ARE GOING TO BE MOST IMPACTED BY THESE TRIALS, AND A PRIORI MAKE SURE THERE'S OUTREACH BEYOND THE FUNDED INSTITUTIONS TO DO THAT. IT'S COMPLICATED AT THE LOCAL LEVEL BECAUSE MUCH HAS TO DO WITH REFERRAL, AND OVERALL TO ANSWER YOUR QUESTION, YES, WE HAVE LOTS OF WORK TO DO BUT I THINK WE'RE BEGINNING TO COLLECT INFORMATION ON THE TOOLS THAT ARE GOING TO HELP US, CERTAINLY GOING BEYOND WHAT WE HAVE TRADITIONAL COLLECTED. WE NEED TO TAKE INTO CONSIDERATION ACCESS, COST, AS WELL AS OTHER THINGS. >> DR. MCCASKILL-STEVENS, I WANT TO CONGRATULATE YOU. WE TOO RARELY SEE PRESENTATIONS LIKE YOU'VE JUST PRESENTED, SO THAT WAS FANTASTIC. AND SO MANY HAVE ALREADY SAID WE SEE NEED FOR IMPROVEMENT. WE HAVE SO MUCH WORK TO DO, AND WE WANT TO ENGAGE IN THAT WORK AND SUPPORT YOU. I THINK ONE OF THE BARRIERS WE'VE SEEN MINORITY SERVING INSTITUTIONS HAS BEEN THE ISSUE OF ELIGIBILITY CRITERIA ON SO MANY CLINICAL TRIALS THAT HAVE, YOU KNOW, LIMITED ELIGIBILITY DUE TO COMORBIDITIES AND CHALLENGES WE TOO OFTEN UNFORTUNATELY SEE AND MINORITY AND UNDERSERVED POPULATIONS. I KNOW THE NCIB MAY WANT TO COMMENT HAS TRIED TO DO WORK AROUND THAT BUT HOW DEEPLY WE'VE ACTUALLY IMPACTED CHANGING ELIGIBILITY CRITERIA FOR US IS A HUGE ISSUE. THE SECOND IS DEVELOPING TRIALS IN AREAS WHERE WE HAVE HIGHER INCIDENCES IN CERTAIN POPULATIONS AND I KNOW WHEN YOU VISITED WE LOOK AT TRIBAL COMMUNITIES WITH SOME OF THE HIGHEST RATES OF KIDNEY AND LIVER CANCER IN THE UNITED STATES YET TRIAL MENUS ARE MORE LIMITED, WAS EXCITED ABOUT THE REPORT DR. SHARPLESS TALKED ABOUT, ABOUT EARLY SCREENS FOR KIDNEY CANCER, WE'RE WORKING ON -- OR FOR LIVER CANCER, WE'RE WORKING ON ONE FOR LIVER CANCER, AND I THINK NATURAL HISTORY AND EVEN PREVENTION SCREENING TRIALS INCLUDING THINGS LIKE THIS IN THE FUTURE COULD BE INCREDIBLE. I JUST WOULD LOVE TO HEAR YOU MAKE A FEW COMMENTS ABOUT WHERE WE ARE WITH ELIGIBILITY ISSUE THAT I THINK CAN BE DISCRIMINATORY AND BUILDING ALMOST I KNOW THE IDEA OF A MORE REGIONAL MENU THAT MATCH POPULATIONS ACTUALLY SERVED WHERE A CENTER IF YOU WILL WOULD BE ALLOWED TO HAVE A DIFFERENT TRIAL MENU, BASED ON THEIR POPULATION, SO COMMENTS ABOUT THAT? BUT FANTASTIC PRESENTATION. >> THANK YOU, CHERYL. LET ME COMMENT ABOUT THE NATIVE AMERICAN POPULATIONS, AS YOU KNOW, WHICH IS VERY, VERY COMPLICATED. SOME OF THE TRIAL IS SPECIFIC, ALSO AN IMPORTANT AREA IS INDIAN HEALTH SERVICE. WE HAVE HAD SUCCESS WITH SPECIFIC TRIALS, AS YOU KNOW, AS I THINK WE ALL APPRECIATE IN CLINICAL TRIALS, MUCH HAS TO DO WITH HAVING AN ADVOCATE, SOME WHO IS EMPASSIONED, A LEADER, A CHAMPION. WE'VE HAD THOSE, THESE HAVE NOT BEEN SUSTAINED. THAT'S ONE BARRIER. CHRONIC DISEASE AND ELIGIBILITY, NEAR AND DEAR TO OUR HEARTS, THERE ARE -- NCI AND ASCO HAS COME UP WITH INITIAL STEPS. ONE THING WE'VE ENCOUNTERED, I THINK A PARTNERSHIP THAT'S NEEDED BETWEEN THE PRIMARY CARE PHYSICIANS AND ONCOLOGISTS. I THINK THAT FOR MANY, THE POPULATIONS, THE BURDEN WITH COMORBIDITY, VERY INVESTED IN THEIR PRIMARY CARE PHYSICIANS AND MANY PATIENTS DON'T -- AREN'T ELIGIBLE BECAUSE OF THEM BUT I THINK THERE'S A FEAR FROM ONCOLOGISTS ABOUT THE CO-MANAGEMENT, PARTICULARLY THAT'S WELL MANAGED, SO WE'RE BRINGING TOGETHER PRIMARY CARE PHYSICIANS TO HOPEFULLY HAVE A STRONGER PARTNERSHIP WITH THE PRIMARY CARE PHYSICIAN, ONOLOGYISTS, PATIENTS BEING RELEASED FROM ONCOLOGIC CARE, PERHAPS BEFORE COVID, A KEY AREA WE'LL INTERVENE. WE'RE COLLECTING THAT INFORMATION, JUST COLLECTING IS NOT ENOUGH BUT WE'VE GOT TO GET SO WE CAN BETTER MANAGE PATIENTS BECAUSE I THINK THAT'S PART OF THE PROBLEM OF THEM NOT GOING ON TO TRIALS. THOSE ARE MY COMMENTS. >> A QUICK FOLLOW-UP COMMENT, I LOVE THE IDEA OF THE PRIMARY CARE ONCOLOGY NETWORK AND HOW YOU MIGHT DO THAT THROUGH THE CANCER CARE DELIVERY PART OF NCORP, FOR INSTANCE IS A REALLY GREAT IDEA TO BUILDING THOSE NETWORKS BUT COME CANCER CENTERS LIKE OURS AND I KNOW OTHERS, 32% OF PATIENTS WHO ENTER OUR COMPREHENSIVE CANCER CENTER HAVE NO PRIMARY CARE PROVIDER. THAT'S THE DISASTROUS STATE OF HEALTH DISPARITIES IN THE REGION WE SERVE, SO OUR ONCOLOGISTS HAVE OFTEN DEALING WITH PRIMARY CARE PROBLEMS, IT'S THE REVERSE ISSUE. I THINK LOOKING AT THAT ISSUE ON BOTH SIDES WOULD BE PHENOMENAL BUT AGAIN I APPLAUD YOU FOR YOUR WORK. >> THANK YOU. >> OTIS? >> THANK YOU. LET ME SPEAK, I GUESS I SHOULD DECLARE THAT I APPLAUD DR. McCASS STEVENS GOOD WORK. I RAN A CANCER CENTER AT ONE TIME, SO I HAVE THOSE TWO PREJUDICE. I THINK THAT THIS DATA SPEAKS TO ACCESS AND FAIRNESS. DO BLACKS, HISPANICS, NATIVE AMERICANS HAVE ACCESS, FAIR ACCESS TO CLINICAL TRIALS. I SPEAK TO THAT BECAUSE I HAVE WRITTEN ABOUT THIS 27 YEARS AGO EVEN, THE NIH REVITALIZATION ACT, CONGRESSIONAL MANDATE, ACTUALL CALLS FOR SUBSET ANALYSIS AMONGST RACES AS IF BLACK IS A BIOLOGICAL CATEGORY DIFFERENT FROM WHITE, DIFFERENT FROM NATIVE AMERICAN. AND I THINK THE POLITICIANS GOT THAT TOTALLY WRONG. I'D LIKE TO POINT OUT THE OMB DIRECTIVE 15 SAYS THEY ARE SOCIOECONOMIC CATEGORIES, AND IF YOU LOOK AT 23ANDME OR ANCESTRY.COM MOST AFRICAN AMERICANS IN COUNTRY INTEREST AT LEAST 10% WHITE ADMIXTURE, CAUCASIAN ADMIXTURE, THAT MAKES SENSE THAT CATEGORY BLACK IS SOCIOECONOMIC AND NOT BIOLOGIC, FOR EXAMPLE. I THINK THAT WE NEED TO -- IN ORDER TO GET THE COMPLETE ANSWER TO THE QUESTION OF SOME DISPARITIES IN HEALTH, WE NEED TO START THINKING ABOUT CERTAIN VERY FOCUSED STUDIES THAT LOOK AT VERY PARTICULAR GROUPS OF INDIVIDUALS WHO DO HAVE AN INCREASED RISK OF A PARTICULAR DISEASE BECAUSE OF, I WILL USE THE CATEGORY, AREA OF GEOGRAPHIC ORIGIN AS OPPOSED TO RACE. FOR EXAMPLE, THERE ARE SOME NATIVE AMERICAN POPULATIONS THAT MAY BE BETTER DEFINED WHO HAVE INCREASED RISK OF GALLBLADDER CANCER. THE AFRICAN, SUB-SAHARAN INCREASED RISK OF PROSTATE CANCER, YOU KNOW, AGAIN I'M GETTING AWAY FROM RACE AND GETTING CLOSE TO AREA OF GEOGRAPHIC ORIGIN AND ASKING THE QUESTION SHOULD WE DO SOME VERY DEFINED STUDIES ON PARTICULAR PROBLEMS THAT ARE REALLY SIGNIFICANT PROBLEMS. NOW, I'LL JUST END BY SAYING WORK DR. MCCASKILL-STEVENS PRESENTED IS WONDERFUL, 11% OF THE AMERICAN POPULATION IS BLACK, 11% OF PEOPLE ON NCI CLINICAL TRIALS ARE BLACK. SO FROM A NATIONAL PERSPECTIVE WE'RE VERY REPRESENTATIVE OF THE POPULATION BUT I'M THINKING ABOUT THESE VERY SPECIFIC TARGETED QUESTIONS ON SPECIFIC AREAS OF GEOGRAPHIC ORIGIN. >> YOU'RE MUTED. >> THANK YOU FOR THAT COMMENT. I APPRECIATE IT. I THINK WE'RE PROBABLY ON THE SAME PAGE. FOR EXAMPLE, YOU KNOW, WHEN WE LOOKED IN THE BRONX, IN NEW YORK, THE THINKING WAS THAT MOST OF THE BLACKS IN THE BRONX WERE AFRICAN AMERICAN BUT IN FACT THE MAJORITY OF THEM WERE ACTUALLY CARIBBEAN. BUT IF YOU DON'T KNOW THEIR COUNTRY OF ORIGIN, IF YOU DON'T HAVE SOMETHING TO GIVE YOU THE INFORMATION THEY ARE CARIBBEAN, FOR EXAMPLE, HIGH RATES OF PROSTATE CANCER, I MEAN, YOU NEED TO START THERE. I THINK I ABSOLUTELY AGREE WITH YOU. WE HAVE ENCOURAGED OUR INVESTIGATORS TO THINK OF THESE TYPES OF STUDIES, TO ADDRESS DISPARITIES IN THE MANNER WHICH YOU'RE SPEAKING ABOUT. >> THE OTHER THING IF I CAN -- JUST ONE MORE THING. AS A FORMER CANCER CENTER DIRECTOR, IN A POOR HOSPITAL, THERE IS THE TENDENCY OR PRESSURE ON THE CANCER CENTER DIRECTOR, ESPECIALLY IN ACADEMIC HOSPITALS, TO DIVERT RESOURCES AWAY FROM PROGRAMS THAT CAN ACTUALLY HELP THE POPULATION AND TO BUILD A PROGRAM TO PUT PEOPLE ON CLINICAL TRIALS, AND THAT CAN ACTUALLY HURT THE HOSPITAL. WE HAVE TO BE CAREFUL THAT THE NIH IN GENERAL IS NOT ENCOURAGING CANCER CENTER DIRECTORS TO TAKE HOSPITAL RESOURCES THAT SHOULD BE GOING INTO OTHER THINGS, MAYBE EVEN OTHER NON-CANCER THINGS, THAT WOULD HELP THEIR COMMUNITY IN ORDER TO BUILD A CANCER RESEARCH ENVIRONMENT. THAT JUST MEANS THE FEDERAL GOVERNMENT NEEDS TO PAY MORE FOR THIS ACCRUAL FROM HOSPITALS THAT -- ESPECIALLY HOSPITALS THAT TAKE CARE OF A LOT OF POOR FOLKS AND HAVE A LOT OF MEDICAID COMING IN. >> THANK YOU. I THINK PERHAPS WE CAN GET COMMENTS FROM SOME OF THE CANCER CENTER DIRECTORS BUT I CAN SHARE ONE OF THE THINGS WE'RE ENCOUNTERING IN THE COMMUNITY SETTING WAS INCREASING NUMBER OF HEALTH SYSTEMS VERY SIMILAR TO THAT IN THAT THE PERCEPTION SUPPORTING RESEARCH IS TO SOME DEGREE RELATIVELY NEW AND WE HAVE TO -- OUR EFFORTS HAVE BEEN DIRECTED TO BETTER ENGAGING THEM TO UNDERSTANDING THE GOALS OF THE COMMUNITY PROGRAMS TO ENGAGE AND SERVE THOSE COMMUNITIES. >> IAN THOMPSON HAS A QUESTION. >> SO, DR. MCCASKILL-STEVENS, I'D LIKE TO ECHO THE GROUP. FABULOUS. I WOULD ALMOST CHARACTERIZE YOURS AS A SPOT-LIKE REPORT ON WHERE WE HAVE MADE PROGRESS A ND WHERE WE HAVE OPPORTUNITIES, HAVING BEEN A CANCER CENTER DIRECTOR OF A REGION PREDOMINANTLY HISPANIC WITH ALL THE UNIQUE CHALLENGES THAT FACE THAT IN A STATE WHERE THERE IS VERY HIGH RATES OF LACK OF HEALTH INSURANCE AND ACCESS TO CARE, RURAL ISSUES. A NUMBER OF YEARS AGO WE WENT BACK AND LOOKED AT HISPANIC ACCRUAL TO PHASE 3 TRIALS, AND ONE OF THE CHALLENGES THAT WE FACED WAS THAT TABLE 1 DOES NOT LOOK THE SAME FOR ALL OF THOSE REPORTS. FOR THOSE OF YOU THAT KNOW WHAT TABLE 1 IS, THE DEMOGRAPHIC CHARACTERIZATION. ONE THING THAT CAME TO MIND WOULDN'T IT BE NICE IF ALL TABLEs 1 LOOKED ALIKE. I'D LIKE TO VOTE, SOME SAY WE CAN COLLECTIVELY SAY IF YOU DON'T HAVE THE DATA, YOU SHOULD BE COLLECTING IT. WHEN YOU DO COLLECT IT YOU SHOULD REPORT ACCORDINGLY SO YOU CAN BE HELD ACCOUNTABLE. >> GREAT. THANK YOU. >> AND A COMMENT ON THE PRIOR DISCUSSION, BOB. >> THANKS, LIZ. I WANTED TO ADD AS WE THINK ABOUT OUR CANCER CENTER IN THE MIDDLE OF PHILADELPHIA, THIS IS A HIGH PRIORITY TO ENSURE ACCESS OF CLINICAL TRIALS TO BLACK PATIENTS IN OUR COMMUNITIES, THE LARGEST MINORITY POPULATION IN THIS CITY. WE REALIZE THERE ARE TWO MAJOR PROBLEMS THAT WE HAD TO ADDRESS AND DID SO OVER THE LAST TEN YEARS, FIRST WHAT OTIS SAID, THAT IS ACCESS TO THIS HEALTH SYSTEM. AND WE CHANGED THAT. WE WERE FAR BELOW SEEING NUMBER OF BLACK PATIENTS WE SAW COMPARED TO NUMBER OF PATIENTS IN THIS CATCHMENT AREA WHO ARE BLACK AND HAD CANCER, SO WE CHANGED ACCESS WE THEN LOOKED AT WHAT HAPPENED TO ENROLLMENT ON INTERVENTIONAL TRIALS, AMONG BLACK PATIENTS. AND IT WENT UP, THE SINGLE MOST IMPORTANT THING WE DID SIMPLY TO IMPROVE ACCESS TO BLACK PATIENTS, BLACK CITIZENS WHO LIVE IN OUR CATCHMENT AREA. YOU HAVE TO STUDY AS A CANCER DIRECTOR WHEN A BLACK PATIENT OR OTHER MINORITY PATIENT IS SEEN AT YOUR CENTER, DO THEY HAVE THE SAME CHANCE OF GOING ON INTERVENTIONAL CLINICAL TRIAL AS OTHER PATIENTS? AND THAT'S THE SECOND HALF OF THE PROBLEM. AND THEY ARE TWO DIFFERENT PROBLEMS. ONE IN THE COMMUNITY, ONE WITHIN YOUR OWN CANCER CENTER. >> DID YOU WANT TO COMMENT ON THAT? >> I APPRECIATE THE COMMENT. >> DEBRA BRUNER, DID YOU WANT TO MAKE A COMMENT OR IS IT JUST MORE CHAT? >> (INDISCERNIBLE). >> SORRY. >> ANY OTHER COMMENTS? >> THIS IS DAN. NED. I WAS SURPRISED. THERE'S BETTER PROGRESS IN A FEW AREAS BUT STILL AREAS WHERE MORE PROGRESS IS NEEDED BUT I THINK THIS IS SOMETHING THE NCI HAS REALLY EMPHASIZED AND CONTINUES TO EMPHASIZE, AND I THINK FEEDBACK OF THIS GROUP IS VERY HELPFUL THROUGH THE DISCUSSION. SO THANK YOU. >> THIS IS A VERY IMPORTANT DISCUSSION, WORTA. THANK YOU FOR THE PARENTHESES THAT BROUGHT UP IMPORTANT POINTS FOR DISCUSSION. >> THANK YOU. >> WE'RE INTO THE MORNING SESSION. TWO LATE QUESTIONS FOR JIM DOROSHOW, WE STILL HAVE A FEW MINUTES SO I'M GOING TO USE MY CHAIRMAN'S PREROGATIVE AND ASK. FIRST, A COMMENT. >> THANKS, LIZ. JUST A CHANCE, JIM, TO GET FEEDBACK. ON THE ELIGIBILITY CRITERIA FOR BIOMARKER STUDY, SINCE APRIL WE NOTICED A MASSIVE NUMBER OF CLINICAL TRIALS WHERE ENROLLMENT IS DIFFICULT BECAUSE WE HAVE MORE TRIALS THAN COVID-19 PATIENTS. THERE'S A QUESTION IN THE -- AN ELIGIBILITY ABOUT THIS 14 DAYS, YOU HAVE TO BE DIAGNOSED WITH COVID WITHIN 14 DAYS. OUR CALCULATION MEANS THAT'S VERY HARD DUE TO QUARANTINE REQUIREMENTS TO GET A PATIENT, AN OUTPATIENT, ON THIS STUDY. COULD THERE BE A WAY TO INCREASE THAT, NOT TO MONTHS AS YOU SAID, I UNDERSTAND THE RATIONALE, BUT MORE THAN TWO WEEKS SO WE CAN HAVE A BETTER CHANCE OF ENROLLING OUTPATIENTS? >> I THINK THE CONSENSUS WAS THERE WOULD BE A PROBLEM IN TERMS OF KNOWING THE IMPACT, BUT WHAT I WOULD ENCOURAGE IS THAT SINCE OUTPATIENT -- PATIENTS CAN BE CONSENTED THEY DON'T HAVE TO BE PRESENT, CAN BE DONE ELECTRONICALLY, RIGHT? THAT IT'S ENTIRELY POSSIBLE THAT SOMEONE IS SEEN, IS TESTED AT ONE OF OUR OUTSIDE SITES OR WHATEVER, CAN BE ENROLLED WITHOUT EVER SETTING FOOT ON THE PENN CAMPUS, RIGHT? SO TO GET AT THEM INITIATED, ONTO THE TRIAL, COULD BE REGISTERED, THEY DON'T HAVE TO BE PHYSICALLY PRESENT. >> YOU CAN DRAW THE BLOOD SOME OTHER TIME? >> EXACTLY. WE'RE TRYING VERY HARD NOT TO MAKE THIS SO DIFFICULT, IF YOU MISSED A BLOOD DRAW THEN, YOU KNOW, ALL HELL IS GOING TO BREAK LOOSE. IT'S JUST THE OPPOSITE, RIGHT? SO I THINK THAT IF IT'S 14 DAYS BUT THEY HAVEN'T SHOWN UP ON CAMPUS, BUT THEY COULD BE CONSENTED, YOU KNOW, ELECTRONICALLY AND MISS THE FIRST BLOOD DRAW THAT WOULD BE FINE. >> OKAY, THANK YOU. >> THIS IS THE BRAVE NEW WORLD OF CLINICAL TRIALS, AND THIS IS SOMETHING I HOPE WHERE WE DON'T GO BACK, RIGHT? WE REMEMBER HOW TO HAVE MORE FLEXIBILITY ABOUT ENROLLMENT IN THE MODERN ERA OF CLINICAL TRIALS EVEN WHEN THE PANDEMIC IS OVER. >> AND THEN DAVID HAD A QUESTION. >> YES, HI. THIS IS FOR JIM BUT WOULD APPLY ALSO TO DR. MCCASKILL-STEVENS. AS WAS SAID, THE NUMBER OF IDEAS THAT COULD BE TESTED IN COVID PATIENTS MAY OUTSTRIP THE NUMBER OF PATIENTS. THE NUMBERS OF CENTERS EXCITED TO DO SOME TRIALS ALSO IS IN ABUNDANCE NOW. ADAPTIVE TRIAL DESIGNS AVAILABLE ORGANIZED POTENTIALLY BY ESSENTIAL AUTHORITY SO THAT LOCAL SITES CAN STILL LEAD ON WHATEVER THEY HAVE INTELLECTUAL CAPITAL IN BUT PATIENTS COULD BE CONTRIBUTED THROUGHOUT THE COUNTRY LIKE THE NCI HAS DONE FOR THE MATCH TRIAL, COULD INCLUDE GROUPS THAT MAY HAVE PARTICULAR ETHNIC BACKGROUNDS, AGE RANGES AND FACTORS SO BOB WOULDN'T BE SO DEPRESSED ALL THE TIME, OR LIZ OR ANY, WE WOULD ALL SEE OUR IDEAS BE TESTED THROUGHOUT THE COUNTRY, WHEREVER THE PATIENTS MAY BE AVAILABLE WITH THE GUIDANCE OF A CONTROL POPULATION WHICH IS ESSENTIAL INSTEAD OF HAVING THESE CASE SERIES REPORTS SO WE HAVE TO HAVE A CONTROL AT ALL TIMES TO ENSURE THAT WE'RE STUDYING SOMETHING IMPORTANT. THE QUESTION TO JIM, ALSO TO THE LAST SPEAKER IN SOME FASHION. THANK YOU. >> SO, THANK YOU. QUICK QUESTION, I THINK YOU SHOULD MAKE IT CLEAR THAT WE HAVE NOT CHOSEN FOR THE MOST PART TO DO VIROLOGY STUDY, TO USE NCI CANCER CLINICAL TRIAL DOLLARS FOR -- >> LET ME INTERJECT. ONE OF THE MAIN CONCERNS MANY OF US HAVE IS THAT OUR CANCER PATIENTS ARE PICKING UP COVID. AS BOB SAID WE DON'T KNOW IF WE CAN BRING THEM BACK TO THE CANCER CENTER OR NOT. AND SO WE HAVE A POPULATION GROWING BEFORE OUR EYES, OF CANCER PATIENTS THAT ARE NOW COVID POSITIVE. AND SO WE DON'T HAVE TO WORRY ABOUT BECOMING VIROLOGISTS, WE HAVE TO WORRY ABOUT STAYING CANCER DOCTORS. I ACTUALLY THINK WE SHOULD EMBRACE IT AND NOT RETREAT. WE MAY HELP THE WHOLE POPULATION BY DOING SO. >> SO THERE ARE MANY -- ONE OF THE REASONS TO DO THE NCCAPS TRIAL, IT'S A NATIONAL TRIAL OPEN AT EVERY SITE WE SUPPORT. >> THE NUMBER OF VARIOUS SMALL RP2-TYPE STUDIES, WHERE YOU WOULD GET REAL ANSWERS, SEQUENTIALLY, SO YOU COULD EXCLUDE OR RULE IN VARIOUS THERAPIES RAPIDLY. I DIDN'T SEE THAT IN THE DESIGN OF ANY OF THAT. AM I MISSING SOMETHING? >> I GUESS IT'S AN EXCELLENT QUESTION. THE REAL ISSUE WILL BE WHAT'S THE RATE THAT WE ACCRUE, BECAUSE THE IDEA IS TO TRY TO BEGIN TO USE THE SPECIMENS IF THEY COME IN FAST ENOUGH, RAPIDLY, NOT TO WAIT. IT'S DESIGNED NOT TO WAIT TILL THE END OF THE STUDY TO ACTUALLY ASK QUESTIONS. SO IF WE GET THE SAMPLES, THAT REPOSITORY WILL BE OPEN TO INVESTIGATORS TO POSE QUESTIONS. >> ESSENTIALLY THE TOPIC SHOULD BE DISCUSSED A BIT MORE BY THOSE OF US IN THE THROES OF TRYING TO DESIGN STUDIES AND WE'RE STARTING UP, RANDOMIZED PHASE 2, GREATER NEW YORK AREA WITH BASIC SCIENCE CANCER CENTER BEING PART OF IT, LOOK AT A PARTICULAR DRUG COMPARED TO PLACEBO BECAUSE WE HAVE A STRONG ENOUGH SIGNAL, TERRIFIC TO HAVE THAT INCORPORATED IN A LARGER FRAMEWORK THINKING ABOUT THIS DISEASE WHICH HAS ACTUALLY NOT GONE AWAY, AND, YOU KNOW, AGAIN IT'S EXCITING TO SEE THE NUMBER OF IDEAS THAT ARE OUT THERE. I DO THINK WE CAN DO A LOT IN THE OUTPATIENT SETTING AS I THINK YOU WERE TELLING BOB, AND I THINK THESE SMALLER POPULATIONS, CANCER POPULATIONS, ETHNIC POPULATIONS, ET CETERA, COULD BE VERY WELL SERVED BY SUCH AN APPROACH. >> GREAT. I THINK UNLESS THERE'S ANY OTHER COMMENTS OR QUESTIONS, WE'VE COME TO THE END OF THE MORNING SESSION. I WANT TO THANK EVERYONE FOR VERY INTERACTIVE DISCUSSION ON EACH OF THE TOPICS. THE TOPICS WERE EXTREMELY WELL PRESENTED AND WE REALLY APPRECIATE AS A COMMUNITY THE UPDATE. SO AT THIS POINT WE'RE GOING TO TAKE A LUNCH BREAK, AND NCIB AND BSA MEMBERS AND NCI STAFF AROUND THE VIRTUAL TABLE WILL GO INTO ADMINISTRATIVE SESSION. THOSE AROUND THE VIRTUAL TABLE AND WEBEX SHOULD NOT DISCONNECT. ALL OTHER PLEASE DISCONNECT AND TAKE A 35-MINUTE BREAK. THE MEETING WILL RESUME PROMPTLY AT 1:00 P.M. AND I WANT TO THANK YOU ALL FOR JOINING VIRTUALLY. WE'LL TAKE A 10-MINUTE BSA AND NCAB WILL TAKE A TEN-MINUTE BREAK AND WILL BE BACK AT 12:30. ANYTHING ELSE, PAULETTE? OKAY, GREAT. SEE YOU IN A FEW MINUTES. >> WELCOME BACK TO THE OPEN SESSION. WE'LL HEAR FROM BSA CHILDHOOD CANCER DATA INITIATIVE, AD HOC WORKING GROUP CHAIRED BY DR. KEVIN SHANNON, UCSF, AND OTIS BRAWLEY, BLOOMBERG DISTINGUISHED PROFESSOR AT JOHNS HOPKINS. THEY ARE GOING TO PRESENT THE WORKING GROUP REPORT, OTIS AND KEVIN, THANK YOU. >> DO I HAVE TO GO AWAY OR CAN I STAY IN? >> THIS IS AN OPEN MEETING. DID YOU HEAR ME, SUSAN? THIS IS OPEN, EVERYONE. PLEASE STAY, I'M GLAD YOU JOINED US, IF YOU'RE BACK. >> HELLO, CAN I START? OKAY, GREAT. IT WAS MY PERIPHERALLY TO CO-CHAIR THIS COMMITTEE WITH DR. KEVIN SHANNON, WHO IS JUST AN EXTRAORDINARY PHYSICIAN AND HUMAN BEING, AND I WILL BE GIVING PRESENTATION FOR THE NEXT 10 TO 12 MINUTES WHAT THE COMMITTEE CAME UP, WORKING GROUP CAME UP WITH. NEXT SLIDE PLEASE. NEXT SLIDE. THIS IS THE WORKING GROUP, A BROAD GROUP OF INDIVIDUALS, DIVERSE BACKGROUNDS, TO INCLUDE SOME PATIENT ADVOCATE PARENTS, AS WELL AS CLINICIANS AND BASIC SCIENTISTS. NEXT PLEASE. THE WORKING GROUP WAS CONVENED BY NED SHARPLESS AND DOUG LOWY, WE WERE ASKED TO GIVE GUIDANCE EFFICIENT WAY TO CHAIR CANCER DATA, TO HELP IDENTIFY THERAPEUTIC TARGETS AND APPROACHES, LEARN ABOUT DRUG DEVELOPMENT, AS WELL AS ENABLE SOME NEW RESEARCH PURSUITS AND UNDERSTAND BIOLOGY OF CANCER. NEXT SLIDE PLEASE. WE STARTED BECAUSE CONGRESS APPROPRIATED MONEY FOR THE CHILDHOOD CANCER DATA INITIATIVE, THE INITIAL APPROPRIATION IS $50 MILLION, WITH THE INTENTION IT'S GOING TO BE $50 MILLION PER YEAR FOR THE NEXT TEN YEARS, TOTAL OF $500 MILLION. NEXT SLIDE. THE GOAL OF COURSE IS TO LEARN SOMETHING FROM EVERY CHILD WITH CANCER SO THAT EVERY CHILD WILL BENEFIT. NEXT SLIDE PLEASE. GOALS TO MAXIMIZE EVERY OPPORTUNITY TO IMPROVE TREATMENT AND OUTCOME, BUILD DATA INFRASTRUCTURE THAT ENABLES SHARING OF CHILDHOOD CANCER DATA, TO IDENTIFY OPPORTUNITIES TO WORK BETTER FOR PATIENTS, CLINICIANS AND RESEARCHERS, TO DEVELOP TOOLS TO EXTRACT DATA. NEXT PLEASE. TALKING ABOUT CHILDHOOD, ADOLESCENT AND YOUNG ADULT CANCER INITIATIVES, THERE'S A LOT OF DATA INITIATIVES INCLUDING BASIC RESEARCH, POPULATION STUDIES, REAL WORLD PATIENT DATA, PRE-CLINICAL MODELS, BIOSPECIMEN REPOSITORIES, AS WELL AS CLINICAL TRIALS. NEXT PLEASE. THAT IS IMPORTANT, AS I WAS STARTING ON THIS PROJECT, I THOUGHT WE WERE TALKING ONLY ABOUT MOLECULAR DATA BUT THERE'S A NUMBER OF DIFFERENT TYPES OF DATA THAT THAT COME FROM SOURCES INCLUDING SOME OF THE LARGE PRIVATE HOSPITALS, CORPORATIONS, AS WELL AS CLINICAL COOPERATIVE GROUPS, GROUPS THAT LOOK AT SURVIVORSHIP, NCI, AND SEER PROGRAM, A NUMBER OF PLACES. WE WANT TO LOOK AT CHILDHOOD CANCER DATA FROM ALL OF THESE THINGS AND FIGURE OUT HOW WE CAN BRING THEM TOGETHER AND ACTUALLY MAKE THE DATA MORE USEFUL PROVIDING IMPROVED UNDERSTANDING OF WHY SOME CANCERS DEVELOP RESISTANCE, FIGURE OUT LESS TOXIC TREATMENT, DEVELOP RESEARCH TOOLS AND THERAPIES AND GENERATE IDEAS FOR INTERVENTIONS. NEXT PLEASE. THE GROUP, THIS IS A 10-MONTH EFFORT, SEPTEMBER OF LAST YEAR. DR. SHARPLESS STARTED BRINGING TOGETHER THE GROUP, THE CHARGE WAS ISSUED IN NOVEMBER, AND HERE IT IS JUNE AND WE'RE PRESENTING OUR REPORT AFTER A NUMBER OF MEETINGS. THIS BECAME PERHAPS THE FIRST WORKING GROUP FOR THE NCI THAT WAS DONE PRIMARILY VIRTUALLY THROUGH -- I GUESS IT'S NOT ZOOM, IT'S ANOTHER PROGRAM, BUT ANYWAY WE HAD ONLY ONE IN-PERSON MEETING. KEY AREAS OF FOCUS, LOOKING AT LANDSCAPE OF PEDIATRIC AND ADOLESCENT YOUNG ADULT CANCER RESEARCH DATA, AND NEEDS ANALYSIS LOOKING AT POTENTIAL BARRIERS TO PROGRESS, GENERATING NEW DATA, DISTINCTION BETWEEN RESEARCH AND CLINICAL DATA, ENGAGING DIVERSE ARRAY OF STAKEHOLDERS FOR INPUT, AND POTENTIAL OPPORTUNITIES FOR TRANSFORMATIVE STUDIES, AND THROUGH THIS CAME UP WITH 24 RECOMMENDATIONS. NEXT PLEASE. THE RECOMMENDATIONS FALL, AND I'VE HIGHLIGHTED OR BOLDED JUST THE CLIFF NOTES VERSION OF RECOMMENDATIONS. WE RECOMMEND FIRST IN TERMS OF TIMES OF DATA FOR COLLECTION AND AGGREGATION LOOK AT CLINICAL OUTCOMES, TREATMENT, EPIGENOMICS, PROTEOMIC, WHOLE EXOME DATA TIMES AND OTHER TYPES OF GENOMIC DATA, LOOK AT AVAILABILITY AND LOCATION OF ARCHIVED BIOSPECIMENS, INCLUDING GERMLINE AND TUMOR DNA THAT MIGHT BE SEQUENCABLE, LOOK AT LONGITUDINAL POPULATION DATA FROM BOTH PATIENTS AND SURVIVORS AND LOOK AT ALSO PATIENT-DERIVED XENOGRAFT AND MOUSE MODELS AND DATA GENERATED FROM THOSE MODELS. NEXT PLEASE. CCDI AGGREGATE FROM PREVIOUS MOLECULAR ANALYSIS, RESPECTIVE OF WHETHER STUDIES, WE REALIZED THERE'S A GROUP OF DATA THAT'S SPECIFICALLY DONE FOR RESEARCH AND DATA DONE FOR CLINICAL TREATMET PURPOSES, WE NEED TO CONSIDER ALL OF THAT DATA AND IMPLEMENT STRATEGIES FOR THE POPULATION. WE DISCUSSED THIS EARLIER, WE KNOW THE PEDIATRIC CLINICAL TRIALS POPULATION IS REPRESENTATIVE OF THE U.S. POPULATION BY RACE AND ETHNICITY, WE DON'T KNOW THE SAME IS TRUE WHEN IT LOOKS AT CERTAIN ASPECTS OF CCDI DATA, FOR EXAMPLE, WHEN WE LOOK AT MOLECULAR SEQUENCING DATA AND SO FORTH. AND WE CERTAINLY DON'T KNOW THAT WE COLLECTED DATA LOOKING AT SOCIOECONOMICS OR SOCIODEPRIVATION AND WE DON'T KNOW THAT DATA IS REPRESENTATIVE. WE SPENT MORE TIME ON THE RACE/ETHNICITY QUESTION THAN THE SOCIOECONOMIC QUESTION. WE ALSO RECOMMEND CCDI EFFORT HAVE PLANS TO TAKE INTO ACCOUNT NEW TECHNOLOGIES AND EVOLVE OVER TIME. NEXT PLEASE. LOOKING AT LANDSCAPE DATA AND NEEDS ANALYSIS WE THINK NCI NEEDS TO ADDRESS WHAT CLINICAL AND MOLECULAR CHARACTERIZATION SAMPLE ARCHIVING SHOULD BE PERFORMED AND WHEN THEY SHOULD BE PERFORMED FOR EACH PEDIATRIC AND AYAK CANCER DIAGNOSIS. I REALIZE THIS IS UNUSUAL THAT WORKING GROUPS DON'T USUALLY RECOMMEND ANOTHER WORKING GROUP. THE WORKING GROUP SUGGESTS WE CONSIDER BOTH CLINICALLY ACTIONABLE SEQUENCING TO INFORM DIAGNOSIS AND THERAPY AS WELL AS DISCOVERY ANALYSIS FOR RESEARCH PURPOSES. ALSO, WE HAVE TO DEAL WITH HOW WE'RE GOING TO PAY FOR ALL OF THIS. WE'RE VERY UNDERSTANDING THAT $50 MILLION A YEAR IS NOT GOING TO PAY FOR, FOR EXAMPLE, GENOMIC SEQUENCING OF ALL PEDIATRIC PATIENTS WHO ARE DIAGNOSED WITH CANCER. WE'RE ALSO UNDERSTANDING THE NCI'S MANDATE IS TO DO RESEARCH AND NOT TO PROVIDE CLINICAL CARE, BUT THE COST OF GATHERING SOME OF THIS INFORMATION MAY VERY WELL BE FAR MORE THAN THE $50 MILLION PER YEAR. WE RECOMMEND THE NCI PERFORM COMPREHENSIVE INVENTORY OF DATA AND DATABASES, SHARED RESEARCH INFRASTRUCTURES FOR WHICH EACH SHOULD BE ASSESSED FOR QUALITY AS WE LOOK AT DATABASES WE KNOW ABOUT, THEY ALL USE VARIOUS DIFFERENCES AND STANDARDS AND QUALITY AND HARMONIZATION, MAY VERY WELL BE A HUGE PROBLEM, GOING FORWARD NCI MIGHT WANT TO SET STANDARDS FOR DATA TO BE COLLECTED FROM VARIOUS SOURCES. NOW, WE ALSO RECOMMEND THE CCDI EFFORTS INCLUDE COLLECTION AND INTEGRATION, IDEAL DATA TYPES PROSPECTIVELY ON EVERY NEWLY DIAGNOSED PATIENT OFFERING STANDARDIZED MARKER OR OMICS TESTING BIOLOGY PANEL FOR EVERY PATIENT. NEXT SLIDE PLEASE. RECOMMENDATIONS LOOKING AT LANDSCAPE OF PEDIATRIC AYA CANCER RESEARCH, WE RECOMMEND THE NCI CONSIDER HOW TO COLLECT ALL TRIAL CLINICAL DATA, RECOMMEND THE NCI REVIEW CURRENT PRACTICES FOR COLLECTING AND CATALOGING BIOSPECIMENS AND ASSIGNING PRIVACY LABELS TO THESE DATA. WE NEED TO FIGURE OUT A WAY THAT WE CAN KEEP SOME TYPE OF ANONYMITY TO THE SPECIMENS, REALIZING WHOLE GENOME DATA IS ALWAYS GOING TO BE IDENTIFIABLE, WITH PEDIATRIC CHILDREN'S ONCOLOGY GROUP HAS ACTUALLY PIONEERED SOME OF THIS LABELING, THAT MIGHT BE ADAPTABLE TO THIS WHOLE PROCESS. WE ALSO REALIZE THE NCI'S DEVELOPING NATIONAL CHILDHOOD CANCER REGISTRY, THIS IS A NATIONAL RESOURCE THAT'S GOING TO BE AGGREGATING QUALITY CLINICAL INFORMATION WITH MOLECULAR DATA AS WELL, SHOULD BE IN THAT DATABASE. NEXT PLEASE. LOOKING AGAIN AT THE LANDSCAPE, WE THINK THE NCI SHOULD CONVENE A BROAD SPECTRUM OF SUBJECT MATTER EXPERTS AND STAKEHOLDERS WITH EXPERTISE IN TECHNOLOGY, DATA SCIENCE TO ASSIST WITH ARCHITECTURE DESIGN AND ROAD MAPPING AND FOCUS ON PRE-CLINICAL DATA AND DEVELOPMENT OF INFRASTRUCTURE AND TOOLS THAT WILL ENHANCE CLINICAL TRANSLATION, THESE EFFORTS FOCUSED ON THE FDA'S RELEVANT MOLECULAR TARGETS LIST, AND FULFILLING MANDATES OF THE RACE FOR CHILDREN ACT. AS NOTED EARLIER, THERE ARE A LOT OF ORGANIZATIONS THAT HAVE DATA, AND WE HAVE TO COME UP WITH SOME WAY TO ENCOURAGE ALL THOSE ORGANIZATIONS TO WORK TOGETHER AND ESPECIALLY TAKE THEIR DATA THAT CAN BE HARMONIZED AND PUT IT ALL WITHIN CCDI, CARROTS TO ENCOURAGE ORGANIZATIONS TO BE WILLING TO PARTICIPATE IS BETTER THAN HAVING SOME STICKS, ALTHOUGH THE NCI MAY WANT TO MAKE PARTICIPATION IN CCDI AS NECESSARY IN ORDER TO GET NCI GRANTS FOR AN ORGANIZATION, IF THAT IS INDEED POSSIBLE. WE ALSO THINK THE NCI SHOULD CONSIDER MULTIPLE AND CREATIVE WAYS TO ENGAGE WITH AND UTILIZE EXPERTISE FROM A WIDE VARIETY OF STAKEHOLDERS AND PEDIATRIC AND AYA SURVIVOR COMMUNITY, PARENTS AS WELL AS PATIENTS, AND SHOULD PURSUE PUBLIC/PRIVATE PARTNERSHIPS WITH OTHER ENTITIES INCLUDING LARGE PEDIATRIC CARE CENTERS, FOUNDATIONS, AND INDUSTRY, AND NCI SHOULD CONSIDER COMMITTING RESOURCES TO CONSENT SEQUENCE SAMPLES AND RETAIN DIVERSE POPULATIONS, DEFINED BY, AGAIN, RACE AND ETHNICITY, AS WELL AS SOCIOECONOMICS, AND GEOGRAPHY. NEXT PLEASE. IN TERMS OF GENERATING NEW IDEAS, THE NCI SHOULD SEEK TO SUPPORT THE GENERATION OF EVIDENCE NEEDED TO CHANGE OUTCOMES FOR PEDIATRIC CANCER. THIS WILL REQUIRE SUPPORTING NEW AS WELL AS EXISTING INITIATIVES, ALIGNED WITH THE NCAB'S AD HOC DATA SCIENCE WORKING GROUP REPORT. THE CCDI NEEDS TO HARMONIZE TECHNOLOGIES AND CODING BETWEEN CANCER RESEARCH AND CLINICAL CARE DATA, AND WE CONCUR THAT APPLYING OF A.I. AND MACHINE LEARNING APPROACHES TO ANALYZE CANCER DATASETS FROM THE ELECTRONIC HEALTH RECORD IS GOING TO BE INCREDIBLY IMPORTANT. THIS IS DIRECTLY FROM THE NCAB AD HOC DATA SCIENCE WORKING GROUP REPORT. AND WE RECOMMEND THAT THE CCDI REMOVE BARRIERS TO DATA ACCESS FOR BROADER COMMUNITY USE BY SUPPORTING THE CREATION OF DATA RESOURCES THAT SIMPLIFY DATA ACCESS, SUCH AS USE OF LIMITED DATASETS, SAFE HARBOR DATASETS AND SYNTHETIC DATASETS THAT CAN BE BROADLY ASSESSED. NEXT SLIDE PLEASE. THE NIH AND NCI SHOULD SET CLEAR EXPECTATIONS REGARDING NEED FOR DATA SHARING, AS NOTED EARLIER AND EXPLORE BARCODING AND -- IS THIS A REPEAT SLIDE? THIS IS A REPEAT SLIDE. NEXT PLEASE. ARE WE IN A CIRCLE HERE? OKAY. WE SHOULD CONSIDER MULTIPLE CREATIVE WAYS TO ENGAGE WITH AND UTILIZE EXPERTISE FROM A WIDE VARIETY OF STAKEHOLDERS AND WE NEED TO COME UP WITH A WAY THAT PARENTS CAN OPT IN AND LATER AS YOUNG ADULTS THE PATIENTS CAN OPT IN OR OPT OUT IN TERMS OF USAGE OF THEIR DATA, AND THE NCI SHOULD CONSIDER DEVELOPING THE CCDI'S INFRASTRUCTURE IN A WAY THAT ALLOWS PATIENTS AND FAMILIES TO SEE THEIR DATA AND ALLOW THEM TO SHARE IT. THERE SHOULD BE A CLEAR MECHANISM FOR SWITCHING CONTROL WHEN THE PATIENT TURNS 18. NEXT PLEASE. WE SHOULD DEVELOP A NATIONAL STRATEGY TO OFFER APPROPRIATE BIOSPECIMEN COLLECTION AND GENOMIC TESTING THAT EVERY PATIENT WITH CANCER WITHIN THE NEXT TWO YEARS, WOULD BE OUR HOPE. WE NEED TO AGGREGATE THAT DATA FROM EXISTING CELL LINES, PATIENT-DERIVED XENOGRAFTS, GENETICALLY ENGINEERING MOUSE MODELS, ANY KIND OF DATA THAT WE CAN ACTUALLY GET. NEXT PLEASE. THERE'S SOME OPPORTUNITIES FOR TRANSFORMATIVE DISCOVERIES HERE. AND THIS INCLUDES IDENTIFYING PATIENTS THAT HAVE A REMARKABLE INITIAL RESPONSE TO CONVENTIONAL OR TARGETED THERAPY AND STUDYING THEM VERY WELL, FOCUS BIOLOGICAL EFFORTS TO DELINEATE MOLECULAR LANDSCAPE AND VULNERABILITIES OF CERTAIN RARE TUMORS. THE CHILDREN'S ONCOLOGY GROUP HAS A REPOSITORY WITH A LARGE NUMBER OF GERMLINE SAMPLES THAT COULD BE USED FOR PREDISPOSITION GENE DISCOVERY, ESPECIALLY FOR HISTOLOGIES, WHERE LARGE GERMLINE ANALYSIS HAVE NOT BEEN DONE SUCH AS LIVER TUMORS AND GERM CELL TUMORS AND WE CAN IMPROVE BIOBANKING EFFORTS AND INTAKE BY ADDING QUALITY CONTROL DIGITAL IMAGE GENERATION, AND NUCLEIC ACID EXTRACTION FOR ALL CHILDREN DIAGNOSED WITH SPECIFIC SOLID TUMORS. NEXT SLIDE PLEASE. THIS IS THE END OF OUR RECOMMENDATIONS. I WANT TO THANK A NUMBER OF INDIVIDUALS WHO WERE VERY HELPFUL FROM THE NCI, AS WELL AS THE FDA, IN CONTRIBUTING SUPPORT TO THE EFFORT TO PUT TOGETHER THIS WORKING GROUP REPORT, AND I ALSO, NEXT SLIDE, WANT TO ESPECIALLY THANK JAMIE GUIDRY AUVIL AND HER STAFF FOR SPECTACULAR SUPPORT OVER THE LAST NINE TO TEN MONTHS. THAT'S THE END OF OUR REPORT. >> THANK YOU. THAT'S TERRIFIC, OTIS. KEVIN, DID YOU WANT TO ADD ANYTHING? >> BRIEF COMMENTS. I THINK A LOT OF LANDSCAPE, AS WE GOT INTO THIS, LIZ, WE BEGAN TO EXPERIENCE THE RUSSIAN DOLL PHENOMENON, OPENED A DOLL AND FOUND ANOTHER QUESTION AND ANOTHER QUESTION. IT WASN'T REALLY AS MUCH ABOUT AGGREGATING DATA ABOUT WHAT DATA EXISTS, NATIONAL STANDARDS. AND HOW DOES THE NCI THINK ABOUT THIS RESEARCH ORGANIZATION BECAUSE A LOT OF THIS HINGES ON A LOT OF QUESTIONS INCLUDING CARE AND THE DIFFERENCE BETWEEN DIAGNOSTIC SEQUENCING AND RESEARCH QUESTIONING, TARGETING TOWARDS TUMORS WITH POOR OUTCOMES WITH PEDIATRIC SEEING CURE RATES, AND THE IMPORTANT ASPECTS OF, NUMBER ONE, MAINTAIN CONTACT AS THEY AGE OUT OF THEIR PARENTS, START THEIR OWN LIVES, CHANGE HEALTH INSURANCE SIX TIMES, AND SO WE CAN TRACK LATE EFFECTS OF THESE TUMOR -- OF THESE THERAPIES WE'RE GIVING THEM FOR MANY, MANY YEARS. SO IT REALLY IS VERY COMPLICATED, AS WE TALKED ABOUT IT, THERE WAS A LOT OF BACK AND FORTH CONVERSATION ABOUT THIS. CERTAINLY OUR APPROACH IS DIFFERENT THAN, SAY, IN GERMANY WHERE EVERYTHING IS DONE IN A CENTRALIZED MANNER, SPECIMENS ARE COLLECTED, MOLECULARLY ANALYZED, AND NATIONAL SORT OF EFFORT IN THIS AREA. WE OBVIOUSLY HAVE DIFFERENT (INDISCERNIBLE) HERE. IT WAS VERY INTERESTING AND THE REPORT PROBABLY RAISED AS MANY QUESTIONS AS IT DID ANSWERED THEM BUT AT LEAST I THINK IT LAID THINGS OUT ON THE TABLE FOR PEOPLE TO DISCUSS. AND I ALSO WANT TO THANK THE NCI STAFF AND EVERYBODY ON THE COMMITTEE, PEOPLE REALLY WORKED HARD, IT'S A REAL SENSE OF COLLEGIALITY IN TRYING TO CONSENSUS AND RESPECT FOR EACH OTHER'S DIFFERENCE OF OPINION. THERE'S A MAN DADE MANDATE BECAUSE OF THE ACT, BRINGING NEW AGENTS TO PEDIATRIC PATIENCE, AND HOW WE'RE GOING TO DO THAT AND WHAT THE ROLE (INDISCERNIBLE) OF MODELS IN RARE CANCERS ARE, THERE'S A LOT OF QUESTIONS AND IF PEOPLE ARE INTERESTED AND HAVE INPUT TO READ THE REPORT WHICH WE TRIED TO KEEP FAIRLY SHORT. IT'S ABOUT TEN PAGES I THINK. THANK YOU BOTH. MICHELLE HAS THE FIRST QUESTION. WE CAN'T HEAR YOU MICHELLE. >> I'D LIKE TO CONGRATULATE OTIS AND KEVIN AND THE WORKING GROUP AND NCI WORKING GROUP. THIS IS A THOUGHTFUL AND COMPREHENSIVE REPORT. I'M VERY SUPPORTIVE OF THE POINTS THAT YOU RAISE. KEVIN, YOU'RE SO RIGHT ABOUT THE RUSSIAN DOLL, WE'VE EXPERIENCED THAT WITH DATA SHARING WORKSHOPS BEFORE. MY QUESTION DOES RELATE TO DATA SHARING. MANY OF US ARE BECOMING INCREASINGLY CONCERNED BY NEW INITIATIVES THAT ARE BEING LAUNCHED BY PRIVATE FOUNDATIONS, THAT MAY BE PARTNERING WITH PUBLIC COMPANIES SUCH AS PHARMA, BUT ARE ALSO ENGAGING ACADEMIC INSTITUTIONS AND GROUPS LIKE COG IN THIS CASE. HOW DO WE INCENTIVIZE THOSE GROUPS TO INCLUDE THEIR DATA IN THIS TYPE OF AN INITIATIVE BECAUSE THEY DON'T REALLY FEEL THE NEED TO DO SO? >> THAT'S A TOUGH QUESTION. I DO NOT TOTALLY HAVE AN ANSWER FOR YOU. ESPECIALLY WHEN WE START TALKING ABOUT DEALING WITH THE PRIVATE CORPORATIONS, YEAH. THE UNIVERSITIES, IT'S A LITTLE EASIER TO ANSWER BUT PRIVATE CORPORATIONS WE DON'T HAVE A BIG STICK ON THEM. >> SURE, BUT THEY ARE BENEFITING FROM THE INFRASTRUCTURE THAT NCI HAS SUPPORTED BUILDING AT ACADEMIC INSTITUTIONS AND GROUPS LIKE COG AND COG SAMPLES, FOR EXAMPLE. >> YEAH. >> GOOD POINT, ESSENTIALLY WHAT OTIS RAISED THAT WE ALL RECOGNIZE, COST OF SEQUENCING. I THINK THAT PUTS BOTH WAYS, WITH THE GENIE CONSORTIUM OF MAJOR CENTERS THAT ARE -- INVOLVES POOLING DATA, AND (INDISCERNIBLE) WITH BIOPHARMA, OPEN PLATFORM, WE'D LIKE TO SEE SOMETHING LIKE THAT IN PEDIATRIC SPACE, PEDIATRIC INSTITUTIONS HAVE BEEN INVITED TO JOIN AND ARE PARTICIPATING. AGAIN, TO GET TO THE RUSSIAN DOLL PROBLEM, A LOT OF ADULT INSTITUTIONS (INDISCERNIBLE) FOR, SAY, COLON OR BREAST OR LUNG CANCER, PHARMACEUTICAL COMPANIES ARE (INDISCERNIBLE). >> YOU'RE GOING IN AND OUT. >> LOOK AT GENIE DATABASE, PEDIATRIC, 85% OF SAMPLES FROM FOREIGN INSTITUTIONS THAT HAVE DONE IT ON MORE OR LESS OF A VOLUNTARY BASIS AT THEIR OWN COAST. CHOP, UCSF, HARVARD, I FORGET THE FOURTH, IT WAS STRIKING. OH, MEMORIAL SLOAN-KETTERING. WE LOOK AT THE FOUR, THOSE WERE THE FOUR THAT WERE CONTRIBUTING 85% OF THE DATA. OBVIOUSLY WE COULD GRAB THAT DATA FROM OTHER PLACES BUT WE MAY NEED TO FUND PEDIATRIC CANCER TO DO IT DIFFERENT THAN THE WAY PHARMACEUTICAL COMPANIES ARE FUNDING GENIE, SO THAT'S ONE EXAMPLE OF THAT. >> A QUESTION FROM LES ROBSON. >> YES, I WANT TO ECHO MICHELLE'S KUDOS FOR A GREAT REPORT AND INITIATIVE THAT I THINK IS INCREDIBLY IMPORTANT. I WANTED TO BRING UP ONE ASPECT I DIDN'T SEE COVERED WELL IN THE REPORT, MENTIONED A FEW TIMES, BUT TO ME THE VERY BASIS FOR AND INITIATIVE, QUALITY OF THE DATA. AND WHILE, YES, THERE'S DISCUSSION ABOUT QUALITY DATA AND SO ON, WHEN WE'RE PULLING DATA TOGETHER FROM SO MANY DIFFERENT SOURCES, I DON'T THINK WE CAN MINIMIZE LEVEL OF INVESTMENT AND INFRASTRUCTURE AND MONITORING THAT'S GOING TO BE REQUIRED TO MAKE SURE THAT THE DATA THAT GOES INTO THIS REPOSITORY IS OF HIGH QUALITY TO ALLOW PEOPLE TO MOVE FORWARD. THAT RELATES TO ANOTHER POINT THAT I FOUND REPORTED, THE RECOMMENDATION, DATA BE POSTED WITHIN 6 TO 12 MONTHS OF COLLECTION. I THINK THAT NEEDS TO BE RECONSIDERED, BECAUSE WE DON'T WANT PEOPLE POSTING DATA BEFORE DATA ARE ADEQUATELY GATHERING AND IN MANY OF THE NCI-FUNDED STUDIES THAT ARE COLLECTING SOME OF THESE DATA WE REALLY DON'T HAVE THE RESOURCES WITHIN THE GRANTS TO GET ON AN ONGOING BASIS, WE DO IT AT CERTAIN TIME POINTS OVER THE SPAN OF THREE TO FOUR YEARS SO I WOULD WORRY A BIT ABOUT MAKING SPEED OVER QUALITY, IN TERMS OF POSTING OF DATA AS THINGS GO FORWARD. I HAVE TO MAKE THE COMMENT THAT THE SECTION ABOUT HOSTING, SO ON, THE PUNITIVE TONY THINK TONE, I THINK WAS WRONG FOR THIS REPORT FRANKLY, CALLING OUT T32 GRANTS, TARGETS, PUNISHING INVESTIGATORS FOR NOT (INDISCERNIBLE) I THINK WE CAN PICK OTHER WAYS OF ACTUALLY GOING AFTER INVESTIGATORS THAT DON'T COMPLY RATHER THAN GOING AFTER TRAINING GRANTS. LASTLY FEDERATION. FEDERATED DATABASE, AGAIN, TO GET BACK TO THE QUALITY, MANY OF THESE FEDERATED DATABASES, I PERSONALLY FEEL THAT THE QUALITY OF THE DATA HAS BEEN VETTED TO AN EXTENT WHERE I THINK THEY MAY BE -- YOU KNOW, IDEAL SOURCES, MAYBE NOT BEING DISMISSED AS POSSIBLE ALTERNATIVE TO CREATING A WHOLE NEW DATASET. SO I WOULD BE INTERESTED, OTIS AND KEVIN, IN TERMS OF DISCUSSIONS ABOUT QUALITY. >> YEAH, I TAKE ALL OF YOUR COMMENTS QUITE SERIOUSLY. THE QUALITY ISSUE, I WOULD AGREE WITH YOU, I THOUGHT IT WAS THERE IN THE REPORT BUT IT DEFINITELY DOES NEED TO BE EMPHASIZED IN A REPORT, ESPECIALLY WHEN WE START TALKING ABOUT MOLECULAR CHARACTERIZATION, THINGS ARE ALL OVER THE BOARD IN TERMS OF WHAT TYPES OF SEQUENCING PEOPLE HAVE BEEN DOING, RNA SEQUENCING, DNA SEQUENCING, PROTEIN, A NUMBER OF DIFFERENT THINGS. AND THEN WHEN YOU GET TO ANY ONE PARTICULAR TYPE OF SEQUENCING, THE QUALITY OF ACTUALLY THAT, YOU KNOW, SEQUENCING IS AN ISSUE. SO, YES, I TAKE EVERYTHING YOU SAID QUITE SERIOUSLY, AND THEY ARE ALL GOOD POINTS. >> I WANTED TO GIVE THE OVER PEOPLE WAITING -- WE ONLY HAVE A MINUTE LEFT, ANNA, TIM, I WILL TRY TO GET TO YOU. >> (INDISCERNIBLE). >> NO, NO, I'VE BEEN GOING IN ORDER. I PROMISE WE'LL GET FRANCIS TOO, AND THAT'S IT. ANNA, MAKE IT BRIEF. >> YES, BRIEFLY, OTIS, DOES THE STAR HELP OR HURT OR ABILITY, ESPECIALLY AROUND PRIVACY? >> I -- LET ME YIELD TO KEVIN ON THAT. I AM WORRIED ABOUT THE STAR ACT. THE RACE ACT IS I THINK MUCH BETTER BUT STAR -- KEVIN? >> YEAH, I'M NOT A SUBJECT MATTER EXPERT. I THINK THAT IN THE INTEREST OF TIME I THINK THAT'S PROBABLY AN IMPORTANT QUESTION FOR NED AND NCI STAFF, I DON'T KNOW THE ANSWER. >> I THINK IT IS. SO STAFF WILL KNOW BUT WE RAN RIGHT INTO IT ON CCDI EARLY ON. SOMEBODY SHOULD TAKE A LOOK AT IT. >> THANK YOU, ANNA. TIM? >> YOU THINK ABOUT THE KINDS OF GENOMIC DATA YOU'LL OBTAIN FROM THE STUDY, IT'S IMPORTANT TO REMEMBER THERE'S REALLY ONLY ONE STABLE GENOMIC PLATFORM GOING FORWARD. THAT'S WHOLE GENOME SEQUENCING. NONE OF THE OTHERS ARE STABLE OVER TIME. NONE OF THEM WILL CREATE THE LONG-TERM GENOMIC INFORMATION THAT EVERYONE REALLY WILL ULTIMATELY NEED TO MAKE THE BEST USE OF THIS STUDY. I HOPE YOU'LL CONSIDER THAT HARMONIZATION TOOL FOR GENOMIC DATA BEING CONSIDERED HERE BECAUSE THAT DECISION COULD HAVE VERY, VERY LONG TERM IMPACT ON ULTIMATE VALUE OF THIS DATA. >> AND FRANCIS? >> I'LL BE BRIEF. VERY NICE WORK. I KNOW THIS WAS DATA WORKING GROUP. HOWEVER, WHEN I LOOK BACK TO MY TIME AS HEAD OF PEDIATRIC ONCOLOGY RESEARCH AT M.D. ANDERSON, ONE OF THE BIGGEST CHALLENGES TO MEANINGFUL RESEARCH IN PEDIATRIC CANCER IS OTHER THAN LEUKEMIA MOST OF THEM ARE VERY, VERY -- SIGNIFICANT PAUCITY IN NUMBER OF TUMORS, VERY FEW PATIENTS, CNS TUMORS, FOR EXAMPLE, SECOND LARGEST TUMOR, SOMETIMES IN SOME CASES LIKE BLASTOMA, YOU HAVE A DOZEN PER INSTITUTION. THIS HAS BEEN A MAJOR, MAJOR OBSTACLE RUNNING CLINICAL TRIALS AND COMPREHENSIVE RESEARCH. WE TOOK GENOMIC DATA, YOU NEED NUMBERS TO DO THAT. I THINK ONE OF THE RECOMMENDATIONS SHOULD BE WAYS TO INCENTIVIZE INSTITUTIONS WORKING TOGETHER. THE PEDIATRIC ONCOLOGY GROUP AND CHILDREN'S CANCER GROUP HAVE DONE QUITE A BIT TO IMPROVE BUT IT'S STILL A MAJOR PROBLEM. MOST INSTITUTIONS KEEP SPECIMENS TO DO THEIR OWN WORK, COMPREHENSIVE LARGER SCALE STUDIES HAVE BEEN A BIG PROBLEM, AND STILL ARE. IN BRAIN TUMORS, ONE OF THE THINGS WE STRUGGLE WITH. SO ANY WAY OR RECOMMENDATIONS FOR INCENTIVES FOR PEOPLE TO WORK TOGETHER AND PUT TOGETHER BIOSPECIMENS, CENTRALIZE, SO IT'S GOING TO GO TO A LONG WAY, DATA WILL BE ANALYZED. >> I NEED A MOTION TO ACCEPT THE REPORT. CAN I HAVE A MOTION? >> SO MOVED. >> SECOND? >> SECOND. >> ANY DISCUSSION BEFORE WE VOTE? ALL IN FAVOR RAISE YOUR HAND FOR ACCEPTING THE REPORT. ANYONE OPPOSED? ANYONE WANT TO ABSTAIN? GREAT. THANKS AGAIN FOR A TERRIFIC REPORT. IT'S ACCEPTED. I TURN THE CHAIRMANSHIP TO DAFNA. >> A TOUGH ACT TO FOLLOW. I'M GOING TO TRY MY BEST. WE'LL BEGIN NOW THE REVIEW OF THE CONCEPTS, TODAY THERE ARE EIGHT NEW AND REISSUE CONCEPTS AS WELL AS REISSUE FOR CONSIDERATION WITH THE EXCEPTION OF THE REISSUE PARs, BSA MEMBERS WILL VOTE TO APPROVE, DISAPPROVE, OR DEFER NEW CONCEPT. IF IT IS A REISSUANCE, MEMBERS WILL VOTE TO CONCUR, NON-CONCUR OR DEFER WITH REISSUANCE. BOTH NCAB AND BSA MEMBERS MAY PARTICIPATE IN THE DISCUSSION OF EACH CONCEPT, BUT ONLY BSA MEMBERS WILL VOTE, BECAUSE OF THE LARGE NUMBER OF CONCEPTS I WILL ENCOURAGE US TO STAY ON SCHEDULE. DURING THE VOTING, I WILL ASK HOW MANY MEMBERS DISAPPROVE, CONCUR, ABSTAIN. WHEN ASKED PLEASE RAISE YOUR HAND AND/OR STATE YOUR NAME SO PAULETTE CAN COUNT AND RECORD THE VOTE. WITHOUT FURTHER ADO LET'S MOVE INTO THE FIRST CONCEPT, A NEW RFA, NEW COHORT TO ASSESS ENVIRONMENTAL EXPOSURES AND CANCER RISK. DR. MAHABIR IS PRESENTING. SANDA? >> SORRY, I'M HAVING SOME DIFFICULTIES WITH MY SLIDES. SORRY, I'M READY NOW. GOOD AFTERNOON. THANKS FOR THIS AFTERNOON TO DISCUSS A NEW COHORT ENVIRONMENTAL EXPOSURES AND CANCER RISK. THE PURPOSE OF THIS RFA TO SUPPORT CANCER ETIOLOGY COHORTS TO USE INNOVATIVE STRATEGIES AND APPROACHES TO ADDRESS KNOWLEDGE GAPS BETWEEN ENVIRONMENTAL EXPOSURES, GENETICS, AND OTHER MOLECULAR FACTORS AND CANCER ETIOLOGY ACROSS DIVERSE POPULATIONS. THE PURPOSE IS ALSO TO ENSURE RIGOR AND REPRODUCIBILITY OF DATA AND BIOSPECIMEN COLLECTIONS. THIS RFA IS RESPONSIVE TO NCI, NCAB COHORT SUBCOMMITTEE REPORT EMPHASIZED NEED FOR NEW ETIOLOGY COHORTS TO ADDRESS RESEARCH GAPS ON EXPOSURES. THE RFA WILL INCORPORATE NCAB'S RECOMMENDATIONS. THE GOAL IS FUND APPROXIMATELY FIVE NEW COHORTS TO ASSESS NEW AND UNDERSTUDIED EXPOSURE WITH INNOVATIVE DESIGNS AND MEASURES, FOCUS ON BOTH SHORT-TERM AND LONGER-TERM RESEARCH QUESTIONS. INVESTIGATORS WILL BE REQUIRED TO COLLABORATE, FACILITATED BY COORDINATING CENTER. THERE WILL BE COMMON DATA ELEMENTS AND BIOSPECIMEN COLLECTIONS AS WELL. PRIORITY WILL BE GIVEN TO INNOVATIVE, SIGNIFICANT AND ACTIONABLE RESEARCH. IN TERMS OF NEED FOR THE NEW ETIOLOGY COHORTS, WE KNOW ENVIRONMENTAL EXPOSURES, EXAMPLE NEW EXPOSURES, PERSISTENT CHEMICALS, AND CHEMICAL MIXTURES, HAVE BEEN UNDERSTUDIED. THE INTERNATIONAL AGENCY FOR CANCER RESEARCH, IARC AND NTP HAVE GROUP 1 OR KNOWN CARCINOGENS TO HUMAN BUS MANY LACK EVIDENCE TO CLASSIFY. IDENTIFICATION OF KEY CARCINOGENIC HALLMARKS ARE NEEDED. CHALLENGE WITH EXISTING COHORTS IS THEY ARE AGING COHORTS, AND THE EXISTING RESOURCES WHILE IMPORTANT HAVE LIMITATIONS IN ADDRESSING CURRENT AND EMERGING GAPS RELATED TO ENVIRONMENTAL EXPOSURES. IN ADDITION THERE'S INADEQUATE REPRESENTATION OF RACIAL AND ETHNIC POPULATIONS, THE RESOURCES OF EXISTING COHORTS, FOR EXAMPLE, DATA AND BIOSPECIMENS CAN BE UTILIZED, USING OTHER MECHANISMS SUCH AS R01. THIS SLIDE IS SHOWING AN EXAMPLE OF A NEW EXPOSURE, EMERGING CLASS PERSISTENT IN THE ENVIRONMENT, ACCUMULATE IN HUMANS AND ANIMALS AS WELL, INCLUDING THINGS LIKE POLYFLUERINATED SUBSTANCES. THE DIAGRAM SHOWS PFAS CONCENTRATION IN THE WATER SUPPLY IN THE UNITED STATES, ON THE X-AXIS IS SHOWN THE TOTAL PFAS IN PARTS PER TRILLION, AND ON THE Y-AXIS IS SHOWN THE 31 STATES AND DISTRICT OF COLUMBIA, AND WHAT THIS NEW DATA IS SHOWING ACTUALLY IS THAT PFAS CONTAMINATION OF DRINKING WATER IS FAR MORE PREVALENT THAN PREVIOUSLY REPORTED. IN TERMS OF CANCER ETIOLOGY COHORTS IN THE EXTRAMURAL PROGRAM, COHORTS ARE AGING COHORTS, I WILL ADDRESS THIS IN FURTHER DETAIL WHEN I DISCUSS THE PORTFOLIO. IN THE DCEG THERE'S SEVERAL COHORTS AND THERE ARE AGING COHORTS AS WELL, EXCEPT FOR THE NEW CONNECT COHORT. I SELECTED AGRICULTURAL HEALTH STUDY, AHS, OCCUPATIONAL COHORT STARTED IN 1993, AND THE USRT, IS ANOTHER OCCUPATIONAL COHORT FOLLOWIG TECHNOLOGY SINCE 1993. BOTH OF THESE LACK ADEQUATE DIVERSITY, THAT MOST OF PARTICIPANTS ARE WHITE SUBJECTS, IN TERMS OF THE CONNECT COHORT WHICH IS THE NEW ONE IT IS DIFFERENT THAN WHAT WE'RE PROPOSING BECAUSE CONNECT IS CONDUCTED WITHIN A SET OF INTEGRATED HEALTH CARE SYSTEMS. IN TERMS OF RELEVANCE TO THE NIH "ALL OF US" PROGRAM, "ALL OF US" IS NOT FOCUSED ON CANCER, AND IT IS ALSO NOT FOCUSED ON ENVIRONMENTAL EXPOSURES. HOWEVER, BIOLOGICAL SPECIMENS HAVE BEEN COLLECTED, AND THIS COULD BE RELEVANT. THE "ALL OF US" PROGRAM IS OPEN SOURCE, AND IT'S AVAILABLE FOR OTHER RESOURCE INVESTIGATIONS. WE ALSO COLLABORATE WITH NIEHS, AND WITHIN THE INTRAMURAL PROGRAM THERE IS THE SISTER STUDY WHICH IS A STUDY OF WOMEN WHOSE SISTER HAVE BREAST CANCER, THIS STUDY ALSO LACKS DIVERSITY, 84% OF THE WOMEN ARE WHITE. THIS SLIDE IS SHOWING EXAM PEELINGS OF RESEARCH THAT INVESTIGATORS COULD DO, SO IN THE SHORT TERM THEY CAN USE THE IARC FRAMEWORK. ALSO IN THE SHORT TERM COULD CONDUCT OTHER BIOLOGICAL ASSAYS, BUILD COHORTS IN THE SHORT TERM. ALSO THEY CAN USE INNOVATIVE RESEARCH STRATEGIES, CASE CONTROL AND COHORT STUDIES IN INITIAL YEARS. THEY TABLE IS SHOWING EXAMPLES OF BIOLOGICAL MECHANISMS, CARCINOGENIC CHARACTERISTICS, IN THE INTEREST OF TIME I WILL GO THROUGH THIS ONE EXAMPLE OF METABOLIC ACTIVATIONS, RESEARCHERS COULD METHOD DNA. WHAT CHEMICAL, FISCAL, LIFESTYLE AND GENETIC FACTORS INTERACT TO AFFECT CANCER RISK IN UNDERSTUDIED POPULATIONS? AND ON YOU ARE TIMING OF ENVIRONMENTAL EXPOSURES, MULTIPLE EXPOSURES, AND CHRONIC LOW-DOSE EXPOSURES ASSOCIATED WITH CANCER DEVELOPMENT? WE ALSO RECOGNIZE CANCER HAS A LOW LATENCY PERIOD, AND WE HAVE CONSIDERED SUSTAINABLE. ABILITY, WE HAVE THE SEER VIRTUAL POOLED REG CITY CANCER LINKAGE SYSTEM, HUMAN HEALTH EXPOSURE ANALYSIS RESOURCE, HHEAR, CO-FUNDED BY NCI, INNOVATIVE MOLECULAR ANALYSIS, IMAT PROGRAMS. R01 GRANT MECHANISMS AS WELL. IN TERMS OF PORTFOLIO ANALYSIS, NCI PROVIDES INFRASTRUCTURE ONLY SUPPORT FOR 16 ETIOLOGY COHORTS, TWO IN PHASED CLOSEOUT, TWO NOT U.S. BASED. THREE STARTED AS RANDOMIZED CONTROL TRIALS, THERE ARE MAIN ISSUES WITH OUR PORTFOLIO, ONE IS AGE, THE MAJORITY OF THE PARTICIPANTS NOW ARE FIVE YEARS OR OLDER, ATTRITION DUE TO DEATHS IS VERY HIGH, 62%. THERE IS ALSO LACK OF DIVERSITY, SO THE MAJORITY OF THE PARTICIPANTS ARE WHITE. AFRICAN AMERICANS ARE 16%, OTHER RACIAL AND ETHNIC GROUPS ARE SMALLER IN TERMS OF PERCENTAGES, WITH GEOGRAPHIC DISPARITIES AND WE NEED TO THINK ABOUT RURAL POPULATION, POPULATIONS OF LOW SES. THE EXISTING COHORTS AS WELL CANNOT ADEQUATELY ADDRESS NEW EXPOSURES, OVERALL IN TERMS OF NCI GRANT PORTFOLIO THERE'S A SCARCITY OF FUNDING OF RESEARCH FOCUSED ON ENVIRONMENTAL EXPOSURES. THIS RFA WILL SUPPORT A COORDINATING CENTER, MAINLY SUPPORTIVE. COORDINATING CENTER WILL HAVE SPECIFIC RESPONSIBILITIES, AND IN THE INTEREST OF TIME AGAIN I WOULD GO TO THIS ONE EXAMPLE, REQUIRED TO COME UP WITH STANDARD OPERATING PROCEDURES, AND THIS COULD AID IN DATA HARMONIZATION. THE RFA WILL FOLLOW THE UG3/UH3 MILESTONE MECHANISM. THE P.I. SETS MILESTONES FOR RECRUITMENT AND DATA COLLECTION, AND IN THE UH3 PHASE THE FOCUS WILL BE ON COMPLETING THE RESEARCH. THIS DIAGRAM IS SHOWING THE UG3/UH3 PROCESS, PRE-AWARD PHASE, DISCUSSIONS WITH P.I., MILESTONES, IN THE UG3 PHASE UP TO TWO YEARS MEET MILESTONES, AFTER WHICH THERE'S A TRANSITION TO UH3 PHASE. EVALUATION CRITERIA PRIORITY WILL BE GIVEN TO INNOVATIVE AND NOVEL PROJECTS, AS WELL AS STUDY DESIGNS, USING TECHNOLOGICAL AND MOLECULAR INNOVATION TO ADDRESS IDENTIFIED RESEARCH GAPS RELATED TO ENVIRONMENTAL EXPOSURES. THERE HAS TO BE ADEQUATE REPRESENTATION OF UNDERSTUDIED POPULATIONS, WE NEED DIVERSE POPULATIONS. THERE HAS TO BE A STRONG SCIENTIFIC JUSTIFICATION FOR RESEARCH QUESTIONS TO BE ADDRESSED, AS WELL AS APPROACH. AND THE POPULATION WILL ALSO HAVE TO BE JUSTIFIED. THAT HAS TO BE A WILLINGNESS TO COLLECT CORE DATA AND BIOLOGICAL SPECIMENS. THE MILESTONES MUST BE APPROPRIATE AND DATA SHARING HAS TO BE IN COMPLIANCE WITH NIH POLICIES, PROPOSALS FOR THE COORDINATING CENTER WILL BE EVALUATED ON EVIDENCE OF HAVING PROVIDED ADMINISTRATIVE AND LOGISTIC SUPPORT FOR COHORTS. IN TERMS OF JUSTIFICATION FOR RFA IN THE BUDGET, SET ASIDE FUNDS ARE REQUIRED AS WELL AS REVIEWERS FROM DIVERSE BACKGROUNDS. THE BUDGET HERE IS SHOWN AS TOTAL COSTS, TOTAL COST FOR FIVE COHORTS ESTIMATED AT $63 MILLION FOR ALL SIX YEARS, AND TOTAL COST FOR COORDINATING CENTER ESTIMATED AT $4.8 MILLION FOR ALL OF THE SIX YEARS. THESE ARE THE REVIEWER COMMENTS, AND WE'RE VERY THANKFUL TO REVIEWERS FOR COMMENTS, AND WE ARE IN FULL AGREEMENT WITH THESE COMMENTS AND INNOVATION IN THE RFA. IN TERMS OF RATIONALE, INADEQUATE ADDRESS CURRENT AND EMERGING GAPS IN DIVERSE POPULATIONS. POPULATIONS HAVE TO BE APPROPRIATELY DEFINED, RELEVANT TO RESEARCH QUESTIONS, INTERNATIONALLY COHORTS WILL BE ALLOWED, BUT THEY HAVE TO SHOW RELEVANCE TO U.S. POPULATIONS. P.I.s WILL BE PART OF THE COLLABORATIVE STEERING COMMITTEE. THANK YOU FOR YOUR TIME. I'M SORRY FOR THE (INDISCERNIBLE). >> THANK YOU FOR THE CLEAR PRESENTATION, THE COMMITTEE MEMBERS THAT REVIEWED, DO YOU WANT TO TAKE IT AWAY? VICKIE? PLEASE TURN OFF THE SLIDES. >> IS THAT OKAY? >> YEAH, THAT WORKS. VICKIE? WE CAN'T HEAR YOU. CAN YOU PLEASE UNMUTE, I.T.? DAFNA, GO TO THE NEXT PERSON AND WE'LL GO BACK TO HER. MELISSA, CAN YOU TAKE OVER? >> I COULD. I DON'T HAVE ALL OF OUR NOTES THAT VICKIE SENT. WE SPENT TIME GOING BACK AND FORTH WITH THE PROPOSAL AND RFA, WE CONCURRED, THERE MIGHT BE A FEW THINGS, WE FELT CONFIDENT THE RFA SHOULD GO FORWARD AND WE WERE DELIGHTED TO SEE THERE WAS ANOTHER PROPOSAL OF SUCH AN RFA THAT WAS AVAILABLE TO POPULATION SCIENCE AND RESEARCHERS. IT'S AN IMPORTANT AREA FOR US TO FOCUS ON SINCE VERY LITTLE HAS BEEN DONE IN THE ENVIRONMENT, AND WE FELT CONFIDENT THAT THIS WAS SOMETHING THAT WAS REALLY IMPORTANT TO THE COMMUNITY AND FOR US TO LEARN MORE ABOUT ENVIRONMENTAL EXPOSURES AND CANCER. I THINK THAT -- I MEAN THE QUESTIONS AND CONCERNS THAT WE HAD WERE ALL RESOLVED THROUGH DISCUSSIONS WITH PROGRAM. VICKIE, ARE YOU ON AND WANT TO ADD, OR TO LES? >> CAN YOU HEAR ME? OUR COMMITTEE SUPPORTS USE OF EVALUATING LINK BETWEEN ENVIRONMENTAL EXPOSURE AND CANCER RISK. AND AS WELL OUTLINED BY DR. MAHIBIR THE MAJORITY OF COHORTS LACKED DIVERSITY AND ARE AGING OUT AND WE'VE REALLY STRONGLY SUPPORTED EMPHASIS OF THIS ON ENVIRONMENTAL EXPOSURES IN UNDERSERVED POPULATIONS. WE FEEL THIS IS LONG OVERDUE. SO, AS MELISSA SAID WE NEEDED CLARIFICATION ON SPECIFIC ISSUES PARTICULARLY WANTED RFP TO SUPPORT STUDIES TRANSFORMATIVE THAT WENT BEYOND USUAL STUDIES, WE FELT SOME STUDIES IN THE PAST HAD QUITE A BIT OF PROMISE BUT FAILED TO DELIVER. SO WEARABLE DEVICES, MOLECULAR SIGNATURES OF EXPOSURE, WE WANTED INVESTIGATORS TO GO BEYOND SORT OF USUAL, AND WE FEEL THIS HAS BEEN WELL ADDRESSED. PART OF THE STRENGTH OF COHORTS WAS BIOBANKING, AND SO ONE OF THE THINGS THAT WE WERE PARTICULARLY FOCUSED ON WAS UNIFORM BIOBANKING PROTOCOLS, ACROSS ALL FIVE COHORTS WITH EMPHASIS ON RIGOR, REPRODUCIBILITY, QUALITY OF TISSUE AND BLOOD PRESERVATION, AND ALSO HARMONIZATION OF PLATFORM AND ASSAYS ACROSS COHORTS. WE ALSO FELT THAT THERE SHOULD BE UNIFORM AND ANNOTATION STANDARDIZED DATA COLLECTION AND PARTICULARLY RECORDED DETERMINANTS OF DISPARITIES. AND THEN IN THE END I THINK IT WAS BROUGHT UP BY THE INVESTIGATORS, CANCER HAS A LONG LATENCY, AND SO WE STRONGLY SUGGESTED CONSIDERATION OF INTERMEDIATE ENDPOINTS IN ADDITION TO CANCER ENDPOINT AND LES EMPHASIZED IMPORTANCE OF OCCUPATIONAL COHORTS. WE FELT WE HAD A LOT OF SUPPORT FOR THE GENERAL AREA OF THIS CONCEPT, FELT THE INVESTIGATORS WENT WELL BEYOND ALL EFFORTS TO ADDRESS THEM. WE WERE SATISFIED WITH THEIR RESPONSE AND ENDORSED THIS CONCEPT. >> THIS IS LES. I WON'T ADD MUCH. IT WAS COVERED NICELY. I THINK THE KEY ISSUE, WE WANTED TO PUSH, THE RFA IS GOING TO HAVE TO REALLY PUSH INVESTIGATORS TO REALLY GO BEYOND AND GO TO THE HIGH LEVEL OF INNOVATION, ESPECIALLY RELATED TO EXPOSURE ASSESSMENTS, RELATED ISSUES. THAT'S ONE OF THE REASONS WHY THERE'S PROBABLY SOMEWHAT OF A DEFICIT OF THESE TYPES OF STUDIES, BECAUSE THEY ARE SO CHALLENGING. I THINK AS THE WORKING GROUP REPORTS RECOMMENDED, IT'S STILL AN IMPORTANT AREA FOR NCI TO INVEST IN. >> OKAY.? I DON'T KNOW WHAT HAPPENED TO DAFNA. >> I'M ON THE PHONE. I DON'T KNOW. CAN YOU HEAR ME NOW? >> WE CAN, YES. >> OKAY. TERRIFIC. SO, I JUST REALLY WANT TO MAKE SURE THAT WE'RE STICKING TO TIME. ARE THERE ANY COMMENTS OR POINTS FOR DISCUSSION ON THIS PARTICULAR CONCEPT? >> THIS IS CHERYL, I HAD A COMMENT, DAFNA. >> SURE. >> JUST QUICKLY, I HAVEN'T READ THIS PROPOSAL BUT I APPRECIATE EVERYONE'S COMMENTS, I'M VERY SUPPORTIVE. IT REMINDS ME OF OTHER RFAs RECENTLY TARGETING MINORITY POPULATIONS THAT HAVE SENSITIVITIES ABOUT BIOSPECIMEN COLLECTION AND FUTURE UNSPECIFIED USE, I UNDERSTAND BIOSPECIMENS COULD BE STORED AND I COULD HAVE TO AGREE TO NIH SHARING FOR RESEARCH PURPOSES, OBVIOUSLY, BUT HAVE YOU GUYS CONSIDERED THOSE KINDS OF SENSITIVITIES? >> OKAY. WHO FROM THE REVIEW COMMITTEE -- >> THAT'S A QUESTION FOR ME I GUESS. YES, THAT'S A VERY IMPORTANT CONCERN THAT WE HAVE. AND WE WILL HAVE TO THINK CAREFULLY ABOUT THAT. WE WILL BE ADDRESSING THESE CONCERNS IN -- WITH THE COORDINATING COMMITTEE, HOW TO PROCEED, BUT SENSITIVE MATTERS, BIOSPECIMEN STORAGE FOR MINORITY POPULATIONS, WE THANK YOU FOR THE COMMENT AND WILL THINK HOW TO ADDRESS IT. >> A QUICK FOLLOW-UP COMMENT, YOU KNOW, THE PATIENT ENGAGEMENT AND CANCER GENOME SEQUENCING RFA, DR. MECHANIC AND DR. GALONDERS, GROUPS BEING IDENTIFIED FOR FUNDING, THERE'S A LOT OF EFFORT GOING INTO DISCUSSION ABOUT SENSITIVE BIOSPECIMEN COLLECTION FOR GENOME SEQUENCING, AND FUTURE USE OF SAMPLES, HOW THAT MIGHT BE CONDITIONED BY ENGAGEMENT AND PARTICIPATION OF COMMUNITIES IN THE RESEARCH AND COMMUNICATION ABOUT THE ONGOING STUDIES. IT WOULD BE INTERESTING FOR THE FUTURE DEVELOPMENT OF THIS RFA MAYBE TO HAVE CONVERSATIONS WITH THEM, I KNOW THERE HAVE BEEN SOME VERY DEEP DISCUSSIONS ABOUT THESE ISSUES THAT COULD BE SYNERGISTIC. >> HER OFFICE IS NEXT TO MINE, CONVERSATIONS ABOUT THOSE THINGS, TRY TO MAKE SURE WE ADDRESS ALL OF THOSE CONCEPTS. >> IF I COULD MAKE A -- IF DAVE COULD MAKE A COMMENT. >> CONNECTING THE CARCINOGEN OR THE PRO CARCINOGEN TO THE TISSUE MUTAGENIZED AS THE OBVIOUS APPROACH BUT I WOULD WONDER IF IN YOUR TISSUE COLLECTION APPROACH YOU COULD ALSO CONSIDER MICROBIOME-RELATED WORK BECAUSE WE NOW HAVE GREAT EVIDENCE THAT THERE'S AN E. COLI THAT MAKES ITS OWN CARCINOGEN, THAT CAUSES A SUBTYPE OF COLON CANCER, THE QUESTION NOW IS ARE ENVIRONMENTAL PERTURBAGENS CAUSING THIS TO EXIST IN THE FIRST PLACE. THE ENVIRONMENTAL AGENTS MAY ALTER THE MICROBIOME TO IN AND OF ITSELF CREATE CARCINOGENS, IF YOU COULD ADD IN LANGUAGE COLLECTION OF MICROBIOME SPECIMENS FOR THIS PURPOSE, THAT WOULD POTENTIALLY BE USEFUL. THANK YOU. >> YES, THANKS, I APPRECIATE THAT COMMENT AS WELL. AND IN TERMS OF BIOLOGICAL SPECIMEN COLLECTION THIS IS IMPORTANT BUT IT (INDISCERNIBLE) OF COURSE AND ALSO, YOU KNOW, IN TERMS OF THE BUDGET CONSIDERATION, WHAT WOULD BE ALLOWED DRIVEN BY SCIENCE, I THINK IT'S A VERY IMPORTANT THING TO ADDRESS, MICROBIOME, AGAIN IT'S SOMETHING THAT WE HAVE TO THINK ABOUT CAREFULLY. >> LIZ, CALL FOR THE MOTION. >> OKAY. I THINK WE CAN MOVE FORWARD WITH VOTING. CAN I CALL FOR A MOTION? >> I MOTION WE ACCEPT. >> OKAY. SECOND? >> SECOND. >> SECOND. >> ANY FURTHER DISCUSSION? OKAY. I WOULD LIKE NOW TO ASK HOW MANY MEMBERS DISAPPROVE. >> ONE PERSON (INDISCERNIBLE) MOVING FORWARD WITH THIS CONCEPT, CORRECT? >> YES. >> CORRECT. >> CORRECT. >> OKAY. >> CORRECT. >> OKAY. ABSTENTIONS? >> I ABSTAIN IN THIS ONE. >> MAY I MAKE ONE SUGGESTION GOING FORWARD WITH THE REST OF THE CONCEPTS? PLEASE KEEP YOUR QUESTIONS AND I WANT TO REMIND THE PRESENTERS THAT YOUR PRESENTATION IS FOR 15 MINUTES, NOT 20 MINUTES. OKAY? THANKS, LIZ. WE CAN GO TO THE NEXT ONE THEN. >> OKAY. NEXT CONCEPT IS A REISSUE RFA, CHILDHOOD CANCER SURVIVORSHIP STUDY, CCSS, SUBCOMMITTEE CONCURRED WITH REISSUANCE, DR. NITA SEIBEL IS PRESENTING. >> YES, THANK YOU VERY MUCH. SO, OVER THE NEXT TEN MINUTES I'D LIKE TO UPDATE YOU ON SOME OF THE RECENT WORK FROM THE CHILDHOOD CANCER SURVIVOR STUDY, AND TO TALK ABOUT SOME OF THE FUTURE OPPORTUNITIES. NEXT SLIDE. AS YOU ALL KNOW THE CHILDHOOD CANCER SURVIVOR STUDY IS A RETROSPECTIVELY ASCERTAINED COHORT WITH ONGOING LONGITUDINAL FOLLOW-UP DIAGNOSED OVER THREE DECADES FROM 1970 TO 1999, ALL LESS THAN 21 YEARS OF AGE AT THE TIMES OF DIAGNOSIS, AND WITH FOLLOWING TIMES OF CANCER. THERE ARE OVER 37,000 ELIGIBLE FIVE-YEAR SURVIVORS, VALUABLE TO LATE MORTALITY STUDIES, OVER 25,000 PARTICIPANTS OF WHICH OVER 14,000 WERE DIAGNOSED BETWEEN 1970 TO 1986 AND OVER 11,000 BETWEEN 1987 TO 1999, AND ALSO OVER 5,000 SIBLING CONTROLS. DETAILED TREATMENT INCLUDING THAT OF RADIATION THERAPY IS COLLECTED ON EACH, AS WELL AS GERMLINE DNA AND IF POSSIBLE AND FOR THOSE PARTICIPANTS WHO DEVELOP SUBSEQUENT MALIGNANT NEOPLASM AND HAVE TISSUE AVAILABLE THIS IS COLLECTED AND BANKED. THIS IS AN OPEN RESOURCE FOR INVESTIGATORS. SELF REPORTED HEALTH, PSYCHOSOCIAL OUTCOME AND RISK FACTORS ARE COLLECTED AT BASELINE AND ON SIX LONGITUDINAL FOLLOW-UP SURVEYS. AND THIS FORMS THE BASIS FOR 360 PUBLICATIONS FROM 700 INVESTIGATORS INCLUDING OVER 80 TRAINEES. AND FROM THIS, THERE HAVE BEEN 54 INVESTIGATOR INITIATED STUDIES WHICH TOTAL $53 MILLION IN GRANT SUPPORTS. NEXT SLIDE PLEASE. CCSF CONTINUES TO INFORM THE THE GUIDELINES, BETWEEN VERSION 4 TO VERSION 5 YOU CAN SEE IMPACT FROM CCSS. PARTICULARLY IN THE AREA OF RADIATION THERAPY, LATE EFFECTS, CANCER EXPERIENCE, THEY HAVE HAD A MAJOR CONTRIBUTION. IN ADDITION, INTERNATIONAL GUIDELINE HARMONIZATION GROUP ALSO HAS REFERENCED AND REFERRED TO THE WORK THAT'S BEEN DONE BY CCSS AND THEIR STATEMENT. NEXT SLIDE. OVER THE NEXT FEW MINUTES I'D LIKE TO UPDATE YOU ON SOME OF THE RECENT FINDINGS. HERE IS EXAMPLE LOOKING TO OUTCOME OF SOLID ORGAN TRANSPLANTATION IN SURVIVORS WITH END ORGAN FAILURE. THOSE CHILDHOOD CANCER SURVIVORS WHO UNDERWENT KIDNEY TRANSPLANT OR HEART TRANSPLANT HAD A FAIRLY GOOD OUTCOME. THIS IS IN COMPARISON TO THOSE WHO HAD A LIVER TRANSLANT OR LUNG TRANSPLANT. YOU CAN SEE HOW THIS REALLY INFORMS MEDICAL COMMUNITY ON THE OUTCOMES OF SOLID ORGAN TRANSPLANTS IN CHILDHOOD CANCER SURVIVORS. NEXT SLIDE. AS MANY ARE AWARE, CCSS HAS BEEN VERY ACTIVE IN DELINEATING THE RISK OF BREAST CANCER, PARTICULARLY IN THOSE YOUNG WOMEN WHO RECEIVED CHEST IRRADIATION FOR HODGKIN'S LYMPHOMA, HOW THIS RISK IS SIMILAR TO THAT OF A BRCA1 CARRIER. THEY IDENTIFIED ALSO THERE WAS INCREASED RISK, FOUR FOLD, WITH ANTRACYCLINE OR ALKYLATOR EXPOSURE, RISK OF ANTRACYCLINE FOR DEVELOPING BREAST CANCER, YOU CAN SEE THE ODDS RATIO FOR THE COMBINATION WAS MUCH HIGHER THAN WITH RADIATION ALONE. NEXT SLIDE PLEASE. IN ADDITION CCSS LOOKED AT OUTCOME OF CHILDHOOD CANCER SURVIVORS WHO GO ON TO DEVELOP BREAST CANCER AND COMPARED THIS TO THE -- USED SEER DATA AS A CONTROL FOR THOSE WOMEN WHO DEVELOPED DE NOVO BREAST CANCER. NOT SURPRISINGLY, CHILDHOOD CANCER SURVIVORS TEN YEAR OVERALL SURVIVAL WAS LOWER, 73%, COMPARED TO THE SEER COHORT. WHEN THEY LOOKED IN DETAIL AS TO THE CAUSE OF DEATH, YOU CAN SEE THERE WAS A SLIGHTLY HIGHER RISK FROM BREAST CANCER FOR THE CHILDHOOD CANCER SURVIVORS, BUT WHAT WAS PARTICULARLY STRIKING WAS INCREASED RISK FROM OTHER COMORBID CONDITIONS. THIS REALLY SPEAKS TO THE IMPORTANCE OF RISK-REDUCING INTERVENTIONS IN CHILDHOOD CANCER SURVIVORS. NEXT SLIDE. RECENTLY CCSS COLLABORATED WITH DUTCH LATER COHORT AND ST. JUDE TO LOOK AT RISK. THIS INVOLVED OVER 29,000 CHILDHOOD CANCER SURVIVORS, AND THEY IDENTIFIED 399 CASES OF CARDIOMYOPATHY WITH MEDIAN FOLLOW-UP OF 20 YEARS, DAUNORUBICIN WAS FELT TO BE EQUAL TAXICS TO DOXORUBICIN, 1 TO 1 RATIO DAUNORUBICIN SLIGHTLY LESS TOXIC, BUT SIGNIFICANTLY UNDERESTIMATED, MORE LIKE 10 TIMES AS CARDIOTOXIC AS DOXORUBICIN. NEXT SLIDE. THIS SLIDE SHOWS OTHER STUDIES LOOKING AT PSYCHOSOCIAL AND COGNITIVE OUTCOMES. I WON'T GO THROUGH ALL THESE BUT DRAW YOUR ATTENTION TO ONE OF THEM, RELATED TO FINANCIAL TOXICITY, THEY HAVE SHOWN CHILDHOOD CANCER SURVIVORS WHO HAVE OUT-OF-POCKET COSTS, MEDICAL COSTS OF GREATER THAN 10% OF THEIR OUTCOME ARE FAR MORE LIKELY TO DEFER CARE OR SKIP TREATMENT FOLLOW-UP THAN THOSE PATIENTS WHO HAVE LESS THAN MEDICAL -- MEDICAL COSTS LESS THAN 10% OF INCOME. CCSS IS RESOURCE FOR GENETIC INVESTIGATION, COLLABORATED WITH DCEG WITH LINDSEY MORTON AND STEPHEN CHANNICK, GWAS STUDY ON 5700 SURVIVORS, GENETIC VARIANTS. AGAIN, THEY HAVE DONE WHOLE EXOME SEQUENCING OF 5400. AND THEN ST. JUDE'S HAS DONE WHOLE GENOME SEQUENCING AND WHOLE EXOME SEQUENCING ON 2900 SURVIVORS WHO WERE DIAGNOSED MORE RECENTLY BETWEEN 1987 TO 1999. SO BY THE END OF 2020, MORE THAN 8, 8,000 CHILDHOOD CANCER SURVIVORS WILL BE SEQUENCED, A RESOURCE FOR INVESTIGATORS. NEXT SLIDE. THIS SLIDE SHOWS THE PROJECTS APPROVED FROM THE GWAS STUDY, TOGETHER DCEG AND CCSS GENETIC WORKING GROUP ISSUED RFP AND THEY ASKED FOR PROPOSALS FOR NONMALIGNANT ADVERSE EVENTS, AND SO YOU CAN SEE THE NUMBER OF PROJECTS THAT WERE APPROVED AND ARE ONGOING USING THOSE DATA. NEXT SLIDE. CCSS HAS ALSO BEEN VERY ACTIVE IN THE AREA OF RANDOMIZED CONTROLLED INTERVENTION TRIALS, AS YOU CAN SEE ON THE TOP THREE STUDIES THAT ARE LISTED, ONES THAT HAVE BEEN RECENTLY COMPLETED, AND THEN ON THE BOTTOM THREE ARE ONES THAT ARE READY TO START, OR SOON OR HAVE ALREADY BEEN ACTIVATED. CCSS IS ALSO LOOKING TRYING TO INCORPORATE MOBILE HEALTH INTO THE INTERVENTION STUDIES. NEXT SLIDE. SO IN ADDITION TO MAINTAINING AND ENHANCING COHORT FOR ALL INVESTIGATORS, THERE ARE SOME OPPORTUNITIES AHEAD, PARTICULARLY AS COHORT IS AGING, NOW AT A POINT WHERE THEY CAN EVALUATE PHYSIOLOGIC AND NEUROCOGNITIVE AGING AND UNDERLYING MECHANISMS OF ACCELERATED AGING IN THIS COHORT. THEY CAN ALSO ENHANCE THE RESOURCE TO BETTER FACILITATE HEALTH SERVICES RESEARCH. AND THEY CAN CONTINUE TO FACILITATE STUDIES UTILIZING GENOMIC DATA FROM THE COHORT AND TO COLLABORATE WITH OTHER COHORTS FOR DATA SHARING. THEY CAN PROMOTE PRECISION PREVENTION BY DEVELOPING CLINICAL RISK PREDICTION TOOLS, AND ESTABLISH CLOUD-BASED DATA SHARING PLATFORM THAT WILL MAKE ALL CCSS DATA INCLUDING BOTH CLINICAL AND GENOMIC DATA READILY AVAILABLE TO ALL INVESTIGATORS. THEY CAN CONTINUE TO EXPAND THE INTERVENTION STUDIES, PARTICULARLY UTILIZING MOBILE HEALTH APPROACHES, AND THEN YOU MIGHT HAVE NOTICED IN THE CONCEPT WE HAD INCLUDED A PROPOSAL FOR LIMITED RECRUITMENT OF WHAT WAS GOING TO BE CALLED CCSS VANGUARD COHORT THAT WOULD BE A PROCESS OF IDENTIFYING, ENROLLING, AND FOLLOW-UP OF SURVIVORS DIAGNOSED BETWEEN 2000 AND 2020 WHO RECEIVED NOVEL THERAPY. BASED ON DISCUSSIONS THAT WE HAD WITH THE BSA SUBCOMMITTEE, WE DECIDED THE TIMING IS NOT REALLY OPTIMAL TO EMBARK ON THIS. SO WHAT WE'RE PROPOSING IS PROVIDE SUPPORT TO DEVELOP A STRATEGY FOR HOW THEY WILL RECRUIT THESE PATIENTS WITH NOVEL THERAPY BUT RECRUIT AN ENTIRE NEW COHORT WITH THE APPROPRIATE CONTROLS THAT WILL BE POWERED TO ANSWER THESE QUESTIONS IN A STRONG SCIENTIFIC MANNER. NEXT SLIDE. THIS IS THE CURRENT BUDGET, $13.4 MILLION FOR OVER FIVE YEARS. AND SO WE'RE REQUESTING ADDITIONAL $300,000 IN DIRECT COSTS TO SUPPORT GATHERING THE DATA, THESE DATA FROM THE INDIVIDUAL INSTITUTIONS, SO THEY CAN REALLY SPECIFICALLY PROPOSE HOW THEY WOULD DESIGN THIS NEW COHORT, WHICH WOULD OCCUR SOMETIME AFTER 2025. NEXT SLIDE. SO WE'RE REQUESTING APPROVAL TO REISSUE A LETTER RFA FOR FIVE YEARS OF FUNDING, $2.74 MILLION, FOR A TOTAL OF 13.7 MILLION IN DIRECT COSTS, TRANSNCI ENDEAVOR, SUPPORTED NOT ONLY BY DCTD BUT DCCPS, DCEG AND DCP, ADDITIONAL CRITERIA HERE, INVESTIGATORS HAVE ACCESS TO GENOMIC AND CLINICAL DATA, EASILY AND TO DEVELOP A FAST TRACK FOR INVESTIGATORS WHO ARE USING CCSS FOR GRANT SUBMISSION. AND TO PROVIDE STRATEGIC PLAN AS WE DISCUSSED FOR HOW A NEW COHORT WOULD LOOK IN THE FUTURE AND I WOULD BE HAPPY TO ANSWER QUESTIONS. THANK YOU. >> THANK YOU, NITA. KEVIN AND CAROL WERE REVIEWERS. KEVIN? >> YEAH, THANKS, NITA, TERRIFIC PRESENTATION. I'LL BE BRIEF. WE CONCURRED AND BASED ON THE WONDERFUL PRESENTATION, FIRST OF ALL, THE INCIDENCE OF EARLY DEATH (INDISCERNIBLE) COMPLICATIONS IS REALLY A HUGE BURDEN FOR CHILDHOOD CANCER SURVIVORS, AND I THINK THAT THE COHORT HAS BEEN REVOLUTIONARY, A WONDERFUL RESOURCE, AND I ALSO THINK CAUTIONARY TALE, ONCOLOGISTS TREATING YOUNGER PATIENTS, YOU KNOW, ADULT SIDE, 20 TO 40, THIS IS ALL HAPPENING IN AGING COHORTS OF ADULTS SO THIS IS CLEARLY SOMETHING THAT NEEDS TO CONTINUE, ONE OF THE BEST INVESTMENTS NCI HAS EVER MADE. WE'VE TALKED ABOUT THE VANGUARD COHORT, AND I THINK NEEDED SOLUTION TO THIS (INDISCERNIBLE) ARE VERY SUPPORTIVE FOR EXAMPLE LOOKING AT NEW THERAPIES, SUCH AS PROTON BEAM RADIATION THERAPY AND KINASE INHIBITORS, AND HOW THEY THEY MAY BE BE CHANGING THE LANDSCAPE, CONCERNED ABOUT BEING SURE THERE WAS ADEQUATE POPULATION, ADEQUATE COHORT THAT COULD BE ASSEMBLED TO REALLY ANSWER THESE QUESTIONS, AND TO REALLY FOCUS ON THOSE NEW AGENTS AT BOTH TARGETED AND NON-TARGETED BECOME OF STANDARD OF CARE. AFTER THINKING ABOUT IT, NITA CAME TO THE CONCLUSION NEEDING STUDIES AND POWER ANALYSES AND DATA GENERATION FROM THE PARTICIPATING INSTITUTION TO FIGURE OUT WHICH WERE THE RIGHT THERAPIES AND RIGHT COHORTS THAT COULD BE ASSEMBLED. AND THEN WE ALSO SPOKE A BIT AND CAROL CAN ADDRESS THIS, THE NEED TO TRAIN THE NEXT GENERATION OF YOUNG INVESTIGATORS IN THIS FIELD, BOTH PEDIATRIC AND ADULT, AND ACCESS CCSS DATA AND INTEGRATE WITH CCDI WE TALKED ABOUT HALF AN HOUR AGO. THOSE ARE MY COMMENTS. I'M VERY SUPPORTIVE OF THIS CONCEPT AND REALLY APPRECIATE HOW NCI STAFF RESPONDED TO CONVERSATIONS WITH THEM. CAROL? >> SURE. SO -- >> CAROL, IF YOU COULD JUST BE BRIEF AND ADD ADDITIONAL COMMENTS, SO WE CAN GET BACK ON SCHEDULE. OKAY? >> SURE. I'LL BE HAPPY TO. SO THE ONLY OTHER KEY ISSUE WAS TRYING TO MAKE SURE THAT THERE WAS ACCESS TO INVESTIGATORS, BOTH NEW AS WELL AS ESTABLISHED INVESTIGATORS, WITH THE IDEA THAT FAST TRACKING PROPOSALS, PARTICULARLY FOR THOSE WHO HAVE THEIR OWN STATISTICAL SUPPORT, ONE OF THE THINGS THAT SLOWS DOWN ACCESS IS NEED TO HAVE PROPOSAL IDENTIFIED ON STATISTICAL TEAM, ONE ISSUE, BUT LOOKING AT WHAT NITA GAVE US, HOW LONG IT TAKES TO PROCESS A PROPOSAL, TO GET IT TO THE POINT OF APPROVAL, AND IT WAS SUBSTANTIAL LENGTH OF TIME THAT WOULD BE DEMOTIVATING PARTICULARLY FOR NEW INVESTIGATORS WHO ARE ON THE TENURE TRACK AND SO THIS WAS SOMETHING THAT WE EMPHASIZED WE WOULD LIKE IN THE NEXT ROUND FOR -- TO BE IMPROVED AND PART OF THE EVALUATION CRITERIA NOW, TO BRING IN SOME -- HOW MANY NON-CCSS INVESTIGATORS THEY ARE BRINGING IN, ALSO TO DEVELOP A FAST TRACK AND REDUCE THE TIME IT TAKES TO GET SOME IDEAS TO IMPROVE THE USE OF THIS VERY IMPORTANT DATASET. DAFNA, THAT'S IT FROM ME. >> THANK YOU, CAROL. VERY IMPORTANT. I ALSO WANTED TO MENTION ON THE CHAT ANNA BARKER MENTIONED THAT SHE THOUGHT IT'S A VERY IMPORTANT STUDY. MELISSA, A BRIEF COMMENT? >> VERY BRIEF. I'VE BEEN ON THE REVIEW COMMITTEE AS PART OF THE SCIENTIFIC ADVISORY COMMITTEE FOR CCSS, AND, CAROL, I WANT TO DISAGREE WITH WHAT YOU'VE BEEN SAYING BECAUSE I'VE BEEN ON THE REVIEW, THEY HAVE BEEN MEETING MULTIPLE TIMES. IT'S EARLY ON AT THE BEGINNING, WELCOMED JUNIOR PEOPLE TO SUBMIT SO THEY HAVE DONE AN INCREDIBLE JOB OF MAKING THE DATASET ACCESSIBLE AND ESPECIALLY TO JUNIOR INVESTIGATORS, THEY HAVE DONE A REALLY GREAT JOB SO I JUST WANTED TO ADD MY COMMENTS. >> THANK YOU, MELISSA. IF THERE ARE NO OTHER URGENT POINTS THAT SOMEONE WANTS TO RAISE BEFORE WE ARE MOVING TO VOTING LET'S DO THAT. SO, THIS IS A REISSUANCE, AND SO WE WILL FIRST START -- CAN SOMEONE CALL FOR A MOTION? >> I'LL CALL FOR A MOTION. >> AND I'LL SECOND. >> ANYBODY WANT TO BRING ANYTHING FOR FURTHER DISCUSSION WITH THE PANEL? IN IF NOT LET ME ASK DOES ANYONE NOT CONCUR? ZERO? OH, NO, ONE. >> NO, I DON'T THINK IT'S ( INDISCERNIBLE). >> MAYBE NOT. ANY ABSTENTIONS? >> THIS IS LES. I'M IN CONFLICT. >> OKAY. >> THIS IS (INDISCERNIBLE), I'M IN CONFLICT AS WELL >> I'M IN CONFLICT. >> OKAY. THREE ABSTENTIONS. PAULETTE, WE'RE GOOD? >> TWO ABSTENTIONS. EVERYBODY CONCURS. YOU'RE GOOD TO GO. >> OKAY. TERRIFIC. OKAY. SO, THE THIRD NEW CONCEPT IS AN RFE, CLINICAL TRIALS MONITORING SERVICE, GARRETT SMITH IS PRESENTING. >> I MADE A MISTAKE, WHILE WE'RE WAITING. TEN MINUTES, NOT 15. >> OKAY. >> I'M GARY SMITH, COR FOR THIS CLINICAL TRIALS MONITORING SERVICE, CO-CORs, ARE ROCIO PAUL AND MIKE MONTELLO. THE CONTRACT IS RECOMPETED, WE'RE GOING FOR TEN YEAR CONTRACT, LEVEL OF CONTRACT WITH COST PLUS (INDISCERNIBLE) THERADEX, TO START MAY 1, 2022. ONE YEAR BASE WITH NINE. THE PURPOSE OF THE CLINICAL TRIALS MONITORING SERVICE TO PROVIDE INFRASTRUCTURE AND CORE SERVICES FOR DATA MANAGEMENT FOR EXPERIMENTAL THERAPEUTICS CLINICAL TRIALS NETWORK, ETCTN, AND OTHER EARLY PHASE CLINICAL TRIALS. WE PROVIDE LIMITED SUPPORT FOR NCTN AND OTHER PROJECTS, ENSURE PROTECTION OF HUMAN SERVICES HIGH QUALITY DATA, COMPLIANCE WITH HHS, NCI, FDA AND GOOD CLINICAL PRACTICE REQUIREMENTS. TASK ONE IS CENTRAL PATIENT REGISTRATION, PROTOCOL PATIENT DATA CAPTURE SYSTEM, USING MEDIDATA RAVE, ENSURE QUALITY OF DATA AND PROVIDES A COORDINATION OF DATA SAFETY MONITORING BOARD FOR RANDOMIZED STUDIES, ALSO PROVIDES WEB REPORTING SYSTEM SO THE IDB MEDICAL OFFICERS CAN HAVE OVERSIGHT THROUGH THE WEB REPORTING SYSTEM FOR STUDIES CTEP AND IND, INVESTIGATIONS IN COMPLIANCE WITH FEDERAL REGULATIONS, NIH/NCI POLICIES AND PROCEDURES, ENSURING INTEGRITY OF DATA. NEXT SLIDE. TASK III CO-SITE VISITATION FOR NCTN NETWORK GROUP AUDITS, FOCUSES ON SITES WITH PAST PERFORMANCE PROBLEMS. TASK IV IS THE AUDITING OF OTHER INSTITUTIONS, MANY ARE BEING PHASED OUT, BECAUSE MOST OF THE CLINICAL TRIALS ARE NOW FALLING UNDER, BUT WE PREVIOUSLY HAD STUDIES NOT UNDER THESE NETWORKS, WHICH WERE PHASE 2 CONSORTIUMS (INDISCERNIBLE) AND THOSE ARE BEING PHASED OUT, MOST STUDIES OR ALL NEW STUDIES ARE UNDER THE (INDISCERNIBLE). NEXT SLIDE. JUST TO GIVE AN IDEA OF THE SCOPE, THERE ARE 8 LEAD ACADEMIC ORGANIZATIONS, 45 AFFILIATED ORGANIZATIONS, 15 EARLY DRUG DEVELOPMENT OPPORTUNITY PROGRAMS, (INDISCERNIBLE) CANCER CENTERS. NEXT SLIDE. RECENT ACCOMPLISHMENTS FOR YEAR, 30 NEW STUDIES BUILT IN MEDIDATA RAVE, 47 I 47 IMPLEMENTED. 1148 ENROLLED. 1070 REVIEWED. ADDITIONALLY 19 COG PHASE 1, REVIEWED AS PART OF ON-SITE AUDITS, 39 CANCER CENTER SITE VISITS. NEXT SLIDE. AN IDEA OF THE BREAKDOWN OF STUDIES, DURING THE PAST THREE YEARS, PHASE 1, PILOT OR OTHER STUDIES, OTHER WAS TISSUE PROCUREMENT STUDIES, THREE IN THE OTHER CATEGORIES, BUT 40 IN PHASE 1 OR PILOT OR OTHER. PHASE 1/2, 8. PHASE 2, THERE WERE 24. RANDOMIZED PHASE 2, THERE WERE 8 STUDIES. NEXT SLIDE. THIS IS THE ETCTN CENTRAL INFRASTRUCTURE SUPPORT, SHARED WITH THE EXCEPTION OF ARROW ON THE LOWER RIGHT-HAND CORNER, CLINICAL TRIALS MONITORING SERVICE. FOR THE NCTN, EACH NETWORK GROUP HAS A COORDINATING CENTER, ETCTN THIS PERFORMED BY CLINICAL TRIALS MONITORING SERVICE, INCLUDES STUDY BUILT IN MEDIDATA RAVE, REVIEW OF DATA I PREVIOUSLY MENTIONED, AND THE DATA SAFETY MONITORING AND REMEMBER REPORTING. NEXT SLIDE. THIS IS DATA SHARED WITH THE NCTN, CLINICAL TRIALS MONITORING SERVICE CONTRACT USING MEDIDATA RAVE AS WELL AS BUSINESS INTELLIGENCE TOOL IZENDA, DATA DRILLING AND WEB REPORTING, PART OF RECOMPETITION PROCESS, CUSTOM FUNCTIONS AND SAMPLE CRFs. NEXT SLIDE. WEB REPORTING SYSTEM ENABLES SUFFICIENT AND COME PRINT DATA REVIEW BY MEDICAL MONITORS AND TORS AND SITE P.I.s, REMINDERS FOR DUE DATES, ONLINE FORMS TO COMMUNICATE WITH MEDICAL MONITORING IDB. NEXT SLIDE. HERE ARE SOME EXAMPLES THAT CAN BE GENERATED FROM WEB REPORTING, REQUIREMENTS, STUDY SPOTS, HAVE TIMELY REVIEW OF SAFETY INFORMATION FOR IND STUDIES WE SPONSOR. NEXT SLIDE. RECENT ACCOMPLISHMENTS, JANUARY 2020 DATASET MAPPING UTILITY WAS LAUNCHED, ENABLES ADVERSE EVENT DATA FROM NCTN STUDIES TO BE MAPPED AND DISPLAYED IN THE WEB REPORTING SYSTEM. IN MARCH 2020 ROLLOUT OF ELECTRONIC CASE REPORT FORMS CDASH COMPLIANT, TRANSITIONS ANNUAL REPORT TO REPORT TO FDA, DATA SAFETY UPDATE REPORT IN PROCESS NOW. THERE'S DATA SAFETY MONITORING BOARD BEING ROLLED OUT AS WE SPEAK. AND THE BIOBANK PROJECT IS BEING WORKED ON AS WELL. NEXT SLIDE. THERE ARE SEVERAL OPTIONS TO THE CONTRACT. OPTION C IS FUNDING OF UP TO THREE GOOD MANUFACTURING PRACTICE AUDITS PER YEAR, OPTION D FUNDING UP TO FIVE GLP AUDITS, OPTION E SUPPORTS ANY MAJOR INITIATIVES THAT MIGHT HAVE TO OCCUR WITHIN THE NEXT TEN YEARS. AND OPTION F IS IMPLEMENTATION OF ELECTRONIC INFORMED CONSENT. THESE WOULD ONLY BE EXERCISED IF NEED BE, AND IF FUNDING WERE AVAILABLE TO MOVE FORWARD WITH THESE ITEMS. BUT PUTTING THEM ON THIS OPTION ENABLES US TO HAVE THEM WITHIN SCOPE OF THE CONTRACT SHOULD WE NEED TO EXERCISE THESE. NEXT SLIDE. HERE'S THE OVERALL BUDGET FOR THE TEN YEARS, STARTING OUT AT $7.5 MILLION, FOR TOTAL OF APPROXIMATELY $89 MILLION OVER THE 10-YEAR TIME FRAME. AND NEXT SLIDE PLEASE. AND JUST TO GIVE A COST COMPARISON, IT'S DIFFICULT TO PARSE OUT EXPENSES, BUT FOR INDUSTRY, PHARMA-LED ONCOLOGY TRIAL FOR PHASE 1 IS APPROXIMATELY $4.5 MILLION BASED ON THE REFERENCE HERE, AND FOR PHASE 2, $11.2 MILLION, SO GIVEN THE VOLUME OF STUDIES THAT WE'RE CONDUCTING, TO BE A VERY COST EFFECTIVE PROCESS. AGAIN, THE CONTRACT THAT I'M SPEAKING OF IS LIMITED TO DATA MANAGEMENT AND ON-SITE REVIEW, THERE ARE OTHER COST AREAS THAT WOULD HAVE TO BE ACCOUNTED FOR BUT GIVEN THE VOLUME WE'RE WELL WITHIN THIS AMOUNT. I'M HAPPY TO ANSWER ANY QUESTIONS YOU MIGHT HAVE. >> DAFNA, GO AHEAD. >> YES. SORRY ABOUT THAT. URGENT CALL. SO YES, WHY DON'T YOU START, KIM. >> WE REVIEWED THIS, DIVING INTO THE SCOPE OF THE WORK, THIS IS A PROGRAM THAT PROVIDES PRETTY COMPREHENSIVE OVERSIGHT COMPLIANCE, ADHERENCE TO REGULATORY STANDARDS, MONITORING AND AUDITING AND PROVIDING DATA MANAGEMENT FOR TRIALS WITHIN THE CTEP SPACE, PREVIOUSLY EXISTING MASTER AGREEMENT, A RECOMPETE. IN ADDITION PART OF WHAT THEY PROVIDE IS AUDITING, AND GO OUT AND DO SITE AUDITING AS WELL AS MAKING ECRF. WE REVIEWED THE COST AND EXPENSE AND HAD THAT LAST DATA WAS RESPONSIVE TO THE REQUEST HELP UNDERSTAND THIS IS IN FACT A COST EFFECTIVE PROGRAM AS WELL AS PROVIDING A GOOD QUALITY OF SERVICE. AND WE ALSO TALKED A BIT ABOUT SOME OF THE ABILITY OF THIS SERVICE TO FLEX AND THAT WAS DEMONSTRATED WITH THE COVID TRANSITION AND SOME THINGS THEY DID THERE. IN PARTICULAR AROUND NOW DOING SOME MORE E-CONSENTING. WE SPENT TIME RELEVANT TO CONVERSATIONS THIS MORNING AS WELL ABOUT, YOU KNOW, WHAT KINDS OF SCALABILITY AND THE FUTURE WORLD OF CLINICAL TRIALS AND THOSE OPTIONS THAT ARE BUILT IN ARE MEANT TO CONVEY SOME OF THE FLEXIBILITY TO ANTICIPATED DIFFERENT FUTURE AND CLINICAL TRIALS SUPPORT. SO OVERALL, I THINK WE HAD A GOOD OPPORTUNITY TO ASK ALL THE QUESTIONS THAT WE WANTED TO HAVE, AND CAN WEIGH MY PERSPECTIVE OF CONCURRENCE. WE'LL SEE IF KEN HAS ANY COMMENTS. >> WELL SUMMARIZED, KIM. THANKS. >> I WOULD JUST SAY THE ABILITY TO PREDICT TEN YEARS IN THE FUTURE, LOOK WHAT WE'RE DOING TODAY, IS DIFFICULT. BUT THEY WERE VERY RESPONSIVE AND THE IDEA OF THINKING ABOUT HOW TO ADAPT AS KEITH STRESSED IN OUR CONVERSATIONS WITH THE ELECTRONIC ASPECTS, ELECTRONIC CONSENT FORMS AND ALL OF THE MONITORING THAT WILL BE DONE MORE AND MORE ONLINE, I THINK IT'S VERY RESPONSIVE PROGRAM AND VERY IMPORTANT PROGRAM FOR THE WORK OF THE NCI. >> I WASN'T GOING TO SAY ANYTHING. CAN I ADD, KEN, NCI LEADERSHIP REALLY SHOULD CONTINUE PROVIDING SUPPORT THROUGH THIS MECHANISM FOR MORE AND MORE REMOTE MONITORING. IT WAS MADE CLEAR LAST FALL THERE WAS ESSENTIALLY NONE AND NOW THERE'S A VAST AMOUNT ONGOING. AND THIS MECHANISM IS NIMBLE AND CAPABLE OF IT, IT JUST HASN'T BEEN THE STANDARD. THAT'S NOT THE NCI'S ISSUE. IT'S ACTUALLY MORE OF THE SITE LEVEL, BECAUSE CANCER CENTERS I GATHER HAVE BEEN RELUCTANT TO GIVE ACCESS FOR MONITORS, FOR REMOTE MONITORING. I WOULD REALLY STRONGLY SUGGEST NED'S EARLIER COMMENT ABOUT MAINTAINING SOME THINGS THAT HAPPENED AS A CONSEQUENCE OF COVID, THIS IS A MAJOR, MAJOR OPPORTUNITY TO REALLY LEAPFROG INTO REMOTE MONITORING THROUGH THIS MECHANISM. >> THANK YOU VERY MUCH. I TOTALLY AGREE WITH YOUR COMMENTS. THANK YOU. >> LIZ? LIZ? >> I THINK YOU WANT DAFNA. >> YEAH, I MEAN DAFNA. >> I'M HERE. >> OKAY.. >> ALL RIGHT. ANY OTHER DISCUSSION, ANYBODY WHO WOULD LIKE TO ADD ANYTHING BEFORE WE MOVE TO VOTING? >> I HAD A QUICK QUESTION, THE 10-YEAR PLAN, IS THERE A REEVALUATION AT FIVE YEARS OR DOES THIS DECISION VALID FOR THE NEXT 10 YEARS? >> OKAY. >> SO IT'S ONE YEAR BASE, IT'S A ONE-YEAR BASE WITH NINE OPTION YEARS. SO-- >> THANK YOU FOR CLARIFYING. >> UH-HUH. >> OKAY. SO WE'RE GOING TO MOVE NOW TO THE VOTING PART OF THE PRESENTATION. I NEED A MOTION. >> MOVE TO CONCUR. >> OKAY. A SECOND? >> AND A SECOND. >> TERRIFIC. ANY OTHER POINTS FOR DISCUSSION? IF NONE, CAN I ASK THOSE WHO DISAPPROVE TO VOTE PLEASE. OKAY. ANY ABSTENTIONS? ALL RIGHT. >> IT'S UNANIMOUS, DAFNA. >> UNANIMOUS, ALL RIGHTY. OKAY. SO NEXT IS NEW RFA, COLLABORATIVE APPROACHES TO ENGINEERED BIOLOGY FOR CANCER APPLICATION, DR. MICHELLE BERNY-LANG IS PRESENTING. MICHELLE? >> THANK YOU, GOOD AFTERNOON. I'M PLEASED TO BE HERE TO SHARE THIS CONCEPT. HIGH LEVEL OVERVIEW TO PROMOTE INNOVATIVE AND NOVEL SYNTHETIC BIOLOGY APPROACHES ACROSS CANCER RESEARCH THROUGH ENGINEER AND CANCER RESEARCHER PARTNERSHIPS, ACROSS NCI, IN COLLABORATION WITH NIBIB. BECAUSE SO MANY PEOPLE PROVIDED INPUT, HOW THIS MIGHT COMPLEMENT PORTFOLIOS I WANTED TO LEAD WITH MY ACKNOWLEDGMENT SLIDE RECOGNIZING OUR GREAT COLLABORATORS AT NIBIB AND ACROSS NCI. I ALSO WANTED TO ACKNOWLEDGE THE BSA SUBCOMMITTEE SHOWN IN THE BOX ON THE BOTTOM, PROVIDED HELPFUL GUIDANCE AND INPUT. I'LL POINT OUT CHANGES THAT WERE MADE IN RESPONSE TO THAT AS I GO THROUGH THE PRESENTATION. TO HIGHLIGHT THE OPPORTUNITY I WANTED TO START WITH DEFINITION OF SYNTHETIC BIOLOGY THAT WE'RE USING IN THIS PARTICULAR CASE AND DISCUSSING SYSTEMATIC DESIGN, CONTROL, IMPROVEMENT OF ENTIRE BIOLOGICAL PATHWAYS, NETWORKS, ORGANISMS USING ENGINEERING DESIGN PRINCIPLES. THE IMAGE IS A CELLULAR ILLUSTRATION, A CELL HAS BEEN ENGINEERED WITH SENSOR, RESPOND TO ENDOGENOUS OR EXOGENOUS INPUT THAT WILL BE RECEIVED AND COMPUTED BY A PROCESSOR, WHICH WILL THEN INITIATE THE RESPONSE THROUGH ACTUATOR, THESE ASPECTS ARE TIGHTLY CONTROLLED AND REGULATED. THE APPROACHES HAVE BEEN ADVANCED BY DEVELOPMENTS IN CELL, MOLECULAR AND GENETIC COMPUTATIONS, CRISPR HELPED MOVE THIS FORWARD. IT CAN BE USE TO TEST MATHEMATICAL MODELS AND THOSE CAN BE USED TO INFORM AND PREDICT BEHAVIOR OF ENGINEERED SYSTEMS. AS TECHNOLOGIES HAVE CONTINUED TO ADVANCE AND DEVELOP, WE'RE AT A POINT WHERE THERE'S TRANSFORMATIVE POTENTIAL TO BRING MORE INTO CANCER RESEARCH. YOU CAN IMAGINE IN THE FUTURE, OPPORTUNITIES TO RECONSTRUCT COMPLEX CELLULAR NETWORKS THAT ARE BEYOND THE COMPLEXITY OF OUR CURRENT TOOLS, WE CAN GET AT CELLULAR PHENOTYPES LIKE FITNESS, OR THE ABILITY TO DETECT TRANSFORMED CELLS AT EARLIEST STAGES AND ALTER TRAJECTORY. I WANT TO TAKE ADVANTAGE OF NIBIB SUPPORT FOR ENGINEERS AND TECHNOLOGY DEVELOPMENT, AND NCI LEADERSHIP IN THE CANCER RESEARCH NEEDS. AND BUILD UPON THE CURRENT NIH INVESTMENT IN GROWING SYNTHETIC BIOLOGY PORTFOLIO. A CONSORTIUM MEETS ANNUALLY TO BRING INVESTIGATORS AND APPROACHES TOGETHER, IMPORTANTLY AT THE FALL 2019 MEETING THERE WERE BREAKOUT SESSIONS LED BY NCI PROGRAM DIRECTORS, IT WAS CLEAR WITH DISCUSSIONS THERE WERE CANCER CHALLENGES REALLY RIPE FOR THESE APPROACHES, BUT THERE ARE GAPS BETWEEN THE SYNTHETIC BIOLOGY AND CANCER RESEARCH COMMUNITIES, AN OPPORTUNITY TO FORM MORE BRIDGES. WE WANT TO TAKE ADVANTAGE OF THE INVESTMENT THAT NIBIB HAS MADE WITH THEIR GROWING GRANT PORTFOLIO, THIS IS LARGELY IN THE TECHNOLOGY DEVELOPMENT SPACE AND APPLIED TO A VARIETY OF BIOLOGICAL SYSTEMS WITH THE LIMITED NUMBER OF APPLICATIONS IN CANCER. SO WE HAVE TECHNOLOGIES THAT ARE THERE AT NIH AND REALLY PRIME TO MOVE INTO CANCER. I'LL GIVE A FEW EXAMPLES ON MY NEXT SLIDE. THE FIRST IS A NOVEL DELIVERY SYSTEM WHERE PLATELETS HAVE BEEN ENGINEERED TO CONTAIN A SPECIFIC THERAPEUTIC CONSENT, THEY CAN RELEASE THAT AT A SPECIFIC SITE, LYSOSOME STORAGE DISEASES, MOVING TO TARGET CIRCULATING TUMOR CELLS. THERE ARE BIOSENSOR APPROACH, BACTERIA ENGINEERED TO SENSE A MICRO NUTRIENT AND RELEASE A PIGMENT BASED UPON CONCENTRATION. YOU CAN MOVE FROM NUTRIENTS TO STUDYING YOUR FAVORITE CANCER BIOMARKER. THERE ARE APPROACHES TO IMPROVE THE SAFETY OF GENE THERAPY WHERE YOU CAN ADD GENETIC SAFETY SWITCHES TO CONTROL CRISPR, BEING USED IN LIVER INJURY AND THIS COULD TRANSITION TO CANCER THERAPY. AND THEN APPROACHES WITH MEMORY CIRCUITS WHERE YOU CAN TRACK LINEAGE AND TRANSCRIPTIONAL HISTORY OF CELLS APPLIED IN BRAIN DEVELOPMENT WITH ABILITY TO SHIFT TO DEVELOPMENT OF BRAIN CANCER, A HANDFUL OF TOOLS AND HOW THEY MAY WORK IN A CANCER SETTING. WHAT WE WANT TO DO IS BRING THESE COMMUNITIES TOGETHER, SO WE'RE EXPANDING THE DIVERSITY OF SYNTHETIC BIOLOGY APPROACHES BEING USED TO ADVANCE CANCER RESEARCH. I SEE THIS AS TWO PARTS THAT WERE BRINGING IN MORE ENGINEERS AND MORE TECHNOLOGIES, IMPORTANTLY WE WANT TO HAVE THE CANCER RESEARCH NEED DRIVE TECHNOLOGY APPLICATION. SO WE'RE LOOKING FOR COMPELLING CANCER RESEARCH QUESTIONS, THAT ARE UNIQUELY SUITED TO BE ADDRESSED BY SYNTHETIC BIOLOGY. CANCER RESEARCH COMMUNITY AND SYNTHETIC BIOLOGY COMMUNITIES ARE EXTREMELY CREATIVE, THEY HAVE A BROAD ABILITY TO FORM DIVERSE RESEARCH DIRECTIONS, A HANDFUL HERE ARE THESE RECORDINGS OF EXPOSURE AND GENETIC CHANGES, BIOSENSORS THAT CAN AMPLY FIVE SIGNALS OR DETECT TRANSIENT AND RECORD AND CONTROLLED THERAPEUTIC DELIVERY OR ACTION. THIS IS AN RFA REQUEST USING U01, REQUIRING WE HAVE ENGINEERING AND CANCER RESEARCH EXPERTISE, INPUT FROM THE SUBCOMMITTEE, THIS COULD BE FROM AN INDIVIDUAL P.I. OR MULTI-P.I.s BRINGING THAT TOGETHER. WE TALKED ABOUT THE USE OF THE COOPERATIVE AGREEMENT MECHANISM WITH SUBCOMMITTEE AND SO I HAVE A FEW POINTS TO EXPLAIN WHY THIS IS HELPFUL. DRAWING FROM EXPERTISE FROM OTHER PROGRAMS THAT NCI BROUGHT DISCIPLINES TOGETHER LIKE THE PHYSICAL SCIENCE ONCOLOGY NETWORK, CANCER SYSTEMS BIOLOGY CONSORTIA, WHERE IT'S BEEN HELPFUL TO HAVE STEERING COMMITTEE AND OTHER ACTIVITIES TO HELP THE GROUP GET ON BOARD, WITH THE FOUR TO SIX AWARDS WE'RE INTERESTED IN SUPPORTING, WE WOULD CONNECT THEM INTO THE BROADER NIH SYNTHETIC BIOLOGY COMMUNITY, AND IMPORTANTLY INTO BROADER CANCER RESEARCH COMMUNITY. DEPENDING UPON THE SCOPE OF RESEARCH THAT COMES IN, WE WOULD CONNECT THEM INTO APPROPRIATE NETWORKS AND CONSORTIA. THEY COULD BE CONNECTED TO IMMUNONETWORK, THEY COULD BE CONNECTED TO THE CANCER SYSTEMS BIOLOGY CONSORTIUM, IF THEY HAVE HUMAN TUMOR ATLAS PERSPECTIVE THERE'S A VARIETY OF WAYS TO CONNECT DEPENDING ON THE RESEARCH THEY CHOOSE TO PURSUE. WE'RE LOOKING TO SUPPORT A SMALL SYNTHETIC TECHNOLOGY CONSORTIUM, ENGINEERING P.I.s AND OTHER P.I.s OF INTEREST WILL COME TOGETHER TO ITERATE ON TECHNOLOGIES FOR MULTIPLE AWARDS FUNDED, FOR FISCAL 21 TO SUPPORT A PROMISING AREA WITH LIMITED NCI PORTFOLIO, CHALLENGING FOR REVIEW BECAUSE OF TRANSDISCIPLINARY RESEARCH. THE RFA WILL CEMENT PARTNERSHIPS WITH NIBIB. THE TOTAL BUDGET REQUEST IS $4.2 MILLION, WE HAVE A $1 MILLION COMMITMENT FROM NIBIB. FEEDBACK FROM THE SUBCOMMITTEE WAS TO TALK ABOUT HOW THIS MIGHT FIT IN BROADER TECHNOLOGY LANDSCAPE AND I'VE SHOWN AN EXAMPLE OF THE PIPELINE HERE AND EXAMPLE PROGRAMS. THIS IS NOT MEANT TO BE EXHAUSTIVE, JUST TO PROVIDE EXAMPLES WITH THE PROGRAM WE'RE DISCUSSING SHOWN AT THE BOTTOM HERE, REALLY SEEING THIS FITTING WITHIN THE CONTEXT OF USE WITH ADVANCED DEVELOPMENT AND SCALING AND OPTIMIZATION, WITH AWARDEES ABLE TO COLLABORATE, AND WE ENVISION BRINGING IN INVESTIGATORS WHO ARE SUCCESSFUL AT THESE EARLIER STAGE TECHNOLOGY DEVELOPMENT PROGRAMS, PREPARED FOR SUCCESSFUL APPLICATION IN THE SYNTHETIC BIOLOGY AND CANCER APPROACH. OVERALL SUCCESS, WE'RE LOOKING FOR SIGNIFICANT COMPELLING CANCER RESEARCH QUESTION THAT'S SUITED WITH SYNTHETIC BIOLOGY TO TACKLE. IN ITEMS OF TECHNOLOGY RELATING BACK TO THE PREVIOUS SLIDE WE'RE LOOKING FOR TECHNOLOGY THAT'S FEASIBLE, EVEN THE FIRST INSTANCE OF APPLYING IN THE CANCER SETTING. A LOT OF APPROACHES HAVE BEEN DONE IN VITRO AND MICROBIAL SYSTEMS REAR WE'RE LOOKING TO MOVE INTO MAMMALIAN TISSUE OR MAMMALIAN MODEL SYSTEMS. ON THE PROGRAM AS A WHOLE LOOKING TO SPUR NEW SUSTAINED COLLABORATIONS BETWEEN ENGINEERS AND CANCER RESEARCHERS, TO HELP PROMOTE THAT WE'RE HAVING A FALL MEETING TO BRING TOGETHER SYNTHETIC BIOLOGY TO SPUR PARTNERSHIPS AND IDEAS , IN TERMS OF OUTPUTS CANCER RESEARCH MEETINGS WHERE THEY MAY NOT BE WELL REPRESENTED, PATENTS AND GRANTS TO CONTINUE RESEARCH AREAS, WITH COOPERATIVE AGREEMENT WE'RE LOOKING FOR SHARED WE SOURCES SUCH AS MODELS UNIQUELY SUITED, SHARED PROTOCOLS AND WE WANT TO THINK ABOUT THE NEXT GENERATION BY TRAINING EARLY CAREER INVESTIGATORS WHO WILL GET TRAINING WITH CANCER AND TECHNOLOGY SIDE. I'LL LEAVE THIS WITH MY FINAL SLIDE, REQUEST FOR THE TRANSNCI AND NIBIB COLLABORATION TO BRING SYNTHETIC BIOLOGY APPROACHES TO ADDRESS IMPORTANT CANCER RESEARCH QUESTIONS AND I WOULD BE HAPPY TO TAKE YOUR QUESTIONS. THANK YOU. >> THANK YOU VERY MUCH, MICHELLE. GREAT PRESENTATION. SYLVIA, JIM AND BOB WERE REVIEWING. SYLVIA, WOULD YOU LIKE TO START US OFF? >> YES, I'M DELIGHTED TO. OUR COMMITTEE HAD A VERY PRODUCTIVE DISCUSSION WITH MICHELLE, AFTERWARDS AS MICHELLE INDICATED SHE FOLLOWED UP WITH AN UPDATED PRESENTATION. AND A DETAILED E-MAIL WITH POINT-BY-POINT RESPONSE TO COMMENTS. OVERALL WE'RE VERY SUPPORTIVE OF THE CONCEPT. WE VIEW IT AS INCREDIBLY TIMELY. WE UNDERSTAND THE IMPORTANCE OF PROMOTING SYNTHETIC BIOLOGY APPROACH TO CANCER RESEARCH AND POTENTIAL SYNTHETIC BIOLOGY CONTRIBUTING ACROSS THE SPECTRUM FROM BASIC BIOLOGY TO RESEARCH WITH TRANSLATIONAL POTENTIAL AREAS OF PREVENTION, DIAGNOSIS AND TREATMENT, PARTICULARLY HAPPY TO SEE THIS ANNOUNCEMENT IS AND NCI-NIBIB PROGRAM, COST SHARING FOR BOTH, THE RELATIONSHIP WITH NIBIB IS CRITICAL, IT IS A PARTNER THAT COMMONLY SUPPORTS ENGINEER TECHNOLOGY DEVELOPMENT. MICHELLE ADDRESSED OUR REQUEST BY PROVIDING MORE EXAM EXAMPLES OF TRANSLATION, MAMMALIAN CELLS, ADDRESSED RELATIONSHIP WITH OTHER NCI PROGRAMS, THE SUPPORT FROM SEVERAL WORKING GROUPS THROUGH SEVERA MEETINGS ON THE TOPIC, IN ADDITION SHE TALKED ABOUT THE IMPORTANCE OF SYNERGY WITH OTHER CONSORTIA, SUCH AS SYSTEMS BIOLOGY CONSORTIUM, AN IMPORTANT ASPECT TO KEEP IN MIND FOR THE SUCCESS OF THE PROGRAM, PARTICULARLY EXCITED ABOUT THIS COMMENT AND I WELCOME MY FELLOW COMMITTEE MEMBERS TO ADD THEIR COMMENTS. >> JIM OR BOB? JIM, YOU'RE ON. >> THANK YOU. YEAH, I'LL SECOND WHAT SYLVIA SAID. THERE'S A LOT OF EXCITEMENT ABOUT IT, A LOT OF DISCUSSION THAT WE INITIALLY HAD WAS ABOUT FIT, AND THIS IS SOMETHING THAT'S REALLY WELL SUITED TOWARDS A COOPERATIVE AGREEMENT. MICHELLE WAS GREAT IN PROVIDING MORE DETAIL ABOUT HOW TO FIT INTO EXISTING NCI PROGRAMS, NIH PROGRAMS, AND I THINK WHEN THIS IS DONE WELL, COOPERATIVE AGREEMENT CAN FACILITATE SOME OF THESE KINDS OF NOVEL INNOVATIVE QUESTIONS. WE'VE ALL SEEN THEM COME UP, WHEN A QUESTION IS URGING SOMETHING, A NEW AREA LIKE THIS, IT'S THE ISSUE OF HOW DOES IT FIT IN. AND THIS CONCEPT AND PRESENTATION AND RESPONSE TO QUESTIONS SHOW A LOT OF CAREFUL THOUGHT BY MICHELLE AND COLLEAGUES HOW IT'S GOING TO FIT IN, POSITIONED FOR SUCCESS. >> BOB? >> I HAVE VERY LITTLE TO ADD. I THINK I CLEARLY AGREE WITH EVERYTHING THAT EVERYONE HAS SAID, THE IMPORTANCE OF IT, AND CERTAINLY AS AN IMMUNOLOGIST WHEN WE THINK ABOUT SPECIFICITY BUT NEED TO THINK ABOUT TIMING, I THINK THIS IS GOING TO BRING FORTH A NUMBER OF DIFFERENT WAYS THAT WE COULD CONTROL THE TIMING OF RELEASE OF ACTIVE COMPOUNDS SO I'M VERY MUCH IN FAVOR OF THIS. >> TERRIFIC. ANY OTHER COMMENTS FROM MEMBERS OF THE BOARD? ARE YOU GETTING TIRED? [LAUGHTER] OKAY. ALL RIGHT. JUST CHECKING, JUST CHECKING. OKAY. I THINK WE'RE READY TO VOTE. I WILL NEED TO HAVE A MOTION, THIS IS A NEW -- >> MOVE TO CONCUR. >> SECOND. >> ANY OTHER DISCUSSION POINTS THAT ANYBODY WANTS TO BRING UP? >> I THINK IT'S VERY EXCITING. VERY EXCITING. >> ALL RIGHT. SO WITH THAT LET ME ASK HOW MANY OF YOU DISAPPOVE, IS THERE ANYBODY HERE THAT IS DISAPPROVING? NONE? ANY ABSTENTIONS? NONE? PAULETTE? >> UNANIMOUS. >> FANTASTIC. OKAY. NEXT IS A REISSUE OF AN RFA, THE NCI PRE-DOCTORAL TO POSTDOCTORAL FELLOW TRANSITION AWARD, F 99/K00, OLIVER BOGLER IS PRESENTING. >> THANK YOU FOR THE OPPORTUNITY TO PRESENT THIS REQUEST TO HAVE THIS RFA REISSUED, NCI PRE-DOC TO POSTDOC FELLOW TRANSITION AWARD. IF I MAY HAVE THE NEXT SLIDE PLEASE. I'LL MENTION THE BACKGROUND, TALK ABOUT AWARD ELEMENTS, HOW WE REVIEW, THE EVALUATION CRITERIA, GIVE A BRIEF PORTFOLIO ANALYSIS AND JUSTIFICATION FOR THE RFA. IF I COULD HAVE THE NEXT SLIDE PLEASE. BACKGROUND IS WELL KNOWN TO EVERYONE. THERE IS A MISMATCH BETWEEN THE NUMBER OF TRAINEES AND NUMBER OF INDEPENDENT INVESTIGATOR POSITIONS. THERE'S BEEN A DOUBLING OF STUDENTS RECEIVING DOCTORATES IN BIOMEDICINE OVER 30 YEARS, TRIPLING OF POSTDOCS, NUMBER OF INDEPENDENT INVESTIGATOR POSITIONS IS NOT INCREASING, AVERAGE AGE OF Ph.D. P.I. FIRST R 01 IS 43. CANCER RESEARCH CAREER IS REWARDING OPTION, TO IDENTIFY BEST OF THE BRIGHTEST AT THE EARLIEST STAGES, ENGAGE AND RETAIN IN CANCER RESEARCH, FACILITATE JOINING TOP LABS IN THE CANCER FIELD AND POSITION THEM FOR APPLYING FOR K99/R00, WHICH IS TRANSITION TO INDEPENDENCE AWARD. WE ESTABLISHED THIS TRANSITION AWARD ABOUT FIVE YEARS AGO, LATE STAGE GRADUATE STUDENTS TO TRANSITION TO POST DOCTORAL STUDIES. YOU CAN SEE HOW THIS AWARD FITS IN WITH OUR GENERAL OFFERINGS IN THIS PART OF THE CAREER STAGE, IT'S RIGHT THERE IN THE RED BOX, WITH GOAL OF FEEDING INTO THE K99/R 00. IT HAS THE FOLLOWING CHARACTERISTICS, HAVING ONE APPLICATION CYCLE PER YEAR, REQUIRE NOM NAPLES OF ONE APPLICANTS PER INSTITUTION PER YEAR. I'LL RETURN TO THAT IN A COUPLE MOMENTS. THE AWARD SUPPORTS UP TO TWO YEARS OF PRE-DOC WORK, FOUR YEARS OF POSTDOC WORK, SO TOTAL OF SIX YEARS. ATTRACTIVE, HOPEFULLY, TO THE COMMUNITY, K00 SALARY LEVELS EXCEED CURRENT STIPENDS, PORTABLE TO ALLOW GRANTEE TO HAVE FLEXIBILITY IN SELECTING POSTDOC TRAINING OPPORTUNITY OF THEIR CHOICE. NEXT SLIDE, YOU CAN SEE HOW THE REVIEW OCCURS. THE APPLICANTS COMES IN AT F 99, INCLUDES QUALITY OF APPLICANT, ACADEMIC AND PUBLICATION RECORD, RECOMMENDATION LETTERS, REQUEST BRIEF UPDATE ON ACCOMPLISHMENTS, WILL LEAD TO THEIR DEGREE, AND WE REQUIRE MENTOR HOLD AN R01 EQUIVALENT GRANT. THAT'S REVIEWED BY A STUDY SECTION IN THE REGULAR MANNER. TRANSITION POINT, BRIEF PROPOSAL FOR THEIR K00 POSTDOCTORAL PHASE, PROPOSAL INCLUDES INFORMATION ON SUPPORT FROM THEIR PROPOSED POSTDOCTORAL MENTOR, SHORT RESEARCH DESCRIPTION, MENTOR REQUIRED TO HOLD R01 OR EQUIVALENT, APPROVED AT THE DISCRETION OF PROGRAM DIRECTORS IN CENTER FOR CANCER TRAINING. NEXT SLIDE YOU CAN SEE OUR LARGELY PLANNED PROGRAM EVALUATION, LARGELY PLANNED BECAUSE AS YOU NOTICED IT'S A SIX-YEAR AWARD. THIS IS THE FIRST REISSUANCE WE'RE REQUESTING, EVEN OUR FIRST COHORT IS NOT COMPLETED THEIR K00 TERM YET, MANY OUTCOMES ON THE RIGHT UNDER MID--TERM AND LONG-TERM WE DON'T HAVE ANY DATA BECAUSE WE HAVEN'T HAD THE OPPORTUNITY TO SEE PEOPLE REACH THAT PHASE. I CAN SHOW YOU SHORT-TERM OUTCOMES OF TRANSITION INTO THE K00s. AT THE RIGHT TIME WE DO PLAN TO DO AN IN-DEPTH QUALITATIVE DATA ANALYSIS, LOOK AT PRODUCTIVITY MEASURES. IT'S STILL A BIT EARLY TO DO THAT IN-DEPTH ANALYSIS. I WOULD LIKE TO SHOW YOU ON THE NEXT SLIDES AND FOLLOWING INFORMATION ON CURRENT PORTFOLIO. YOU CAN SEE THE FOUR COHORTS, STARTING IN FY16, AND WE'RE WORKING ON FINALIZING THE FIFTH COHORT NOW, IT HASN'T BEEN FINALIZED YET. YOU CAN SEE THE NUMBER OF APPLICATIONS, NUMBER OF AWARDS. THERE WERE 36, NOW IN THE MID-20s. SUCCESS RATES WITH GOOD. ACTUALLY ON A PAR WITH MOST OF THE TRAINING AWARDS AT NCI. AND THEN ON THE RIGHT-HAND TABLE IN COHORTS 1 AND 2 WE HAVE 100% SUCCESS RATE FOR COMPLETING THEIR GRADUATE WORK, THE NUMBER WHO TRANSITIONED, MOST ARE DOING K00s IN CANCER CENTERS, ABOUT 85%, AND UNFORTUNATELY NONE HAVE JOINED THE INTRAMURAL PROGRAM YET BUT THERE'S STILL HOPE. A SMALL NUMBER STARTED APPLYING FOR THE K99/R00, IT'S STILL TOO EARLY FOR MOST BUT IT'S NOT SURPRISING THESE NUMBERS ARE SMALL. NEXT SLIDE YOU CAN GET A FEELING THROUGH THE INFOGRAPHIC OF THE BREADTH OF SCIENCE THAT OUR F 99 AWARDEES ARE FOCUSING ON, AND I SHOULD MENTION THE F 99 PHASE DOES NOT HAVE TO BE CANCER FOCUSED BUT K00 PHASE DOES. SO IT'S A BROAD SPECTRUM. YOU CAN SEE DATA ON EXISTING COHORTS. OF THOSE K99s THAT HAVE BEEN APPLIED FOR THERE'S SOME PENDING REVIEW. THERE'S ONLY A COUPLE WHO ARE NOT IN CANCER RESEARCH, FRANKLY, FOR F 99 PHASE, MAJORITIES ARE IN THAT AREA. QUITE A FEW PUBLICATIONS FROM THESE COHORTS, AND THEN SOME OF THEM COME FROM F31s, AND THIS AWARD MECHANISM ALLOWS NON-U.S. CITIZENS TO APPLY, SO YOU CAN SEE STATISTICS THERE ON U.S. CITIZENS AND NON-CITIZENS, NON-CITIZEN NATIONALS OR PERMANENT RESIDENTS AND TEMPORARY U.S. VISAS. NEXT SLIDE GIVERS JUSTIFICATION FOR WHY WE WOULD LIKE TO CONTINUE IN AN RFA. NEXT SLIDE PLEASE. THANK YOU. NO, SORRY, ONE BACK. APOLOGIES. MAYBE MY COMPUTER IS SLOW. THIS IS THE JUSTIFICATION. DOING AN RFA NOTIFIES THE COMMUNITY OF THE INTENDED SIZE AND SCOPE, 24 AWARDS PER YEAR IS TARGET, DEMONSTRATING COMMITMENT TO CAREER PHASE, ALLOWS SPECIAL REVIEW CRITERION, SPECIAL REVIEW PANEL, WHICH IS IMPORTANT BECAUSE WE NEED A WIDE RANGE OF SCIENTIFIC EXPERTISE TO BE REPRESENTED ON THE PANEL AND WE NEED FAMILIARITY WITH TRAINING AWARDS BECAUSE THESE ARE NOT PRIMARILY RESEARCH PLAN DRIVEN APPLICATIONS. SO WE PROPOSE 24 AWARDS PER YEAR, APPROXIMATELY. AND ONE RECEIPT DATE PER YEAR FOR FIVE YEARS. THAT'S THE WHY. TOTAL COST PER COHORT IS ABOUT $11 MILLION. SO FOR FIVE YEARS, IT WOULD BE FIVE TIMES THAT. NEXT SLIDE YOU CAN SEE A LOOK AT GEOGRAPHIC DISTRIBUTION, AND ONE OF THE REASONS THE CURRENT APPROACH OF ONE NOMINEE PER INSTITUTION I THINK PROVIDES US WITH SOME OPPORTUNITIES. IN THE TOP SET OF TEXT AND GRAPH AND MAP YOU CAN SEE K99 R00, DOES NOT HAVE NOMINATION REQUIREMENTS, YOU CAN SEE OF THE AWARDS THAT HAVE BEEN MADE FOR THAT MECHANISM, 444 TO DATE SINCE THIS IS 2007, ABOUT 40% OF THEM HAVE GONE TO THREE CONGRESSIONAL DISTRICTS. LOOK AT THE TOP FOUR INSTITUTIONS, THEY IN COMBINATION MANAGED TO GET 27% OF AWARDS. IN CONTRAST F 99/K00 EACH CAN NOMINATE ONE APPLICANTS GEOGRAPHIC DISTRIBUTION IS MORE EVEN, TOP THREE CONGRESSIONAL DISTRICTS HAVE ONLY 18% OF THE AWARDS, ABOUT HALF THAT OF THE K99, TOP FOUR INSTITUTIONS TOGETHER HAD 14% OF TOTAL AWARDS, AND YOU CAN SEE THAT GRAPHICALLY AND ON THE MAP. WE BELIEVE THIS APPROACH GIVES SOME ABILITY TO CONTINUE TO LET PEOPLE ACROSS THE COUNTRY KNOW ABOUT THIS PARTICULAR MECHANISM AND ENCOURAGE THEM TO APPLY. ON THE NEXT SLIDE THEN IS THE BUDGET PROPOSAL, THIS JUST GIVES AN IDEA OF WHAT EACH COHORT OF 24 APPLICANTS OR AWARDEES RATHER WOULD COST. ON THE LEFT YOU SEE F 99 PHASE, THERE'S A STIPEND, INSTITUTIONAL ALLOWANCE, ANNUAL MEETING WHERE WE CONVENE THE GRANTEES HERE AT NCI IN ORDER TO BRING THEM TOGETHER AND SUPPORT THEM. THERE'S SOME TUITION AND SO ON, SO THAT'S ABOUT 47,000 PER INDIVIDUAL, FOR TOTAL OF $1.1 MILLION, YOU CAN SEE THE NUMBER PER YEAR TWO, TRANSITION TO K00 PHASE THE COSTS GO UP AND THEY ALSO CHANGE NOW THEY HAVE A SALARY, INSTITUTIONAL ALLOWANCE, YOU CAN READ IT FOR YOURSELF. ABOUT $2 MILLION APPROXIMATELY FOR YEARS THREE, FOUR, FIVE AND SIX. TOTAL COST PER COHORT IS $11 MILLION. NEXT SLIDE SHOWS THE NEXT FIVE YEARS, SO YEAR ONE WOULD BE FY 21, A SINGLE COHORT OF F 99s, CONDITIONED YOU CAN SEE OTHER COHORTS LINING UP. NEXT SLIDE, IF WE WERE SUCCESSFUL WE COULD HAVE TEN COHORTS, FOUR ALREADY AWARDED FROM THE LAST AWARD, ONE IN THE PROGRESS BEING DONE FINALIZED NOW, AND FIVE MORE COHORTS FOLLOWING. SO THAT'S IT FOR MY PRESENTATION. I WOULD BE GLAD TO ANSWER ANY QUESTIONS. THANK YOU VERY MUCH. >> THANK YOU VERY MUCH, OLIVER. THE COMMITTEE MEMBERS THAT REVIEWED WERE MICHELLE, EILEEN, CHERYL. MICHELLE, DO YOU WANT TO START US OFF? >> CERTAINLY. THANK YOU, DR. BOGLER. I'D LIKE TO THANK MY CO-REVIEWERS WHO SHARED THEIR EXPERTISE AND PERSPECTIVE THROUGH TELEPHONE CALLS, ELECTRONIC COMMUNICATIONS AND REVIEWING THE RESPONSES THAT DR. BOGLER SUBMITTED IN RESPONSE TO OUR QUESTIONS. WE RECOGNIZED THE STRONG GOAL, COMPELLING GOAL OF THIS RFA AND THIS PROGRAM, TO RETAIN THE MOST TALENTED GRADUATE STUDENTS, TO IDENTIFY THOSE WHO HAVE THE CAPACITY TO DEVELOP INTO INDEPENDENT INVESTIGATORS AND PROVIDE A PATH BY WHICH THEY CAN TRANSITION THROUGH THE TRAINING PHASES AND ALLOW THEM TO REACH INDEPENDENCE AS QUICKLY AS POSSIBLE. WE THOUGHT THAT THERE WERE A NUMBER OF VERY IMPORTANT POSITIVE POINTS ABOUT THIS PROPOSAL. IT WAS VERY WELL WRITTEN. AND VERY THOROUGH. I THINK ONE OF THE IMPORTANT POINTS IS THAT IT IS A UNIQUE PROGRAM. THERE'S NO OTHER MECHANISM AT NIH TO SUPPORT TRANSITION TO POSTDOCTORAL FELLOWS. WE FELT RECRITERIA WAS STRONG AND VIGOROUS, I WON'T BELABOR. WE FELT IT WAS BORN IMPORTANT TO BE OPEN TO ALL APPLICANTS, AND IT ALLOWS STUDENTS WHO START CAREER IN A NON-CANCER FIELD TO APPLY THEIR WORK TO CANCER, AND THIS MAY HAVE THE OPPORTUNITY TO DRAW PEOPLE FROM AREAS THAT WE NEED TO GROW IN CANCER SCIENCE SUCH AS QUANTITATIVE SCIENCE, BIOINFORMATICS, AND THIS TYPE OF PROGRAM MAKES INDIVIDUALS MORE COMPETITIVE FOR POSTDOCTORAL TRAINING AT THE TOP INSTITUTIONS, AND ONE OF THE THINGS THAT WE'RE ALL SEEING NOW AT OUR INSTITUTIONS IS HOW MUCH WE VALUE AN INDIVIDUAL WHO HAS SHOWN THAT THEY ARE ABLE TO SECURE K99 AND R00, THIS MAKES THESE INDIVIDUALS MORE COMPETITIVE BY GIVING THEM PAST EXPERIENCE AND TRAINING IN APPLYING FOR THESE TYPES OF AWARD. FINALLY WE FELT THERE'S A RIGOROUS PLAN FOR EVALUATING THE PLAN BUT AS DR. BOGLER PRESENTED IT'S STILL EARLY DAYS, THERE WILL BE MORE INFORMATION COMING OVER THE NEXT FEW YEARS. WE HAVE SEVERAL QUESTIONS. AND THEY RELATED TO THE EXPECTED GEOGRAPHIC DISTRIBUTION, ENSURING THAT THERE WAS GOOD REPRESENTATION ACROSS THE COUNTRY, AND WE HAD ASKED WHAT MECHANISMS THEY HAD IN PLACE TO ASSURE THAT THE POOL OF INVESTIGATORS WOULD BE REPRESENTATIVE ACROSS THE SPECTRUM OF INSTITUTIONS. AND WE HAD ALSO ASKED WHAT STEPS MIGHT BE TAKEN TO ENSURE THAT THERE'S APPROPRIATE GENDER REPRESENTATION AND INCLUSION OF INDIVIDUALS FROM UNDERREPRESENTED POPULATIONS. AND DR. BOGLER WAS ABLE TO PROVIDE INFORMATION REGARDING THE GEOGRAPHIC DISTRIBUTION AND REASSURE US THE APPROACH ALLOWING ONE APPLICATION PER INSTITUTION ENABLED SPREADING OF THE AWARDEES ACROSS THE COUNTRY THAT WAS APPROPRIATE FOR THIS TYPE OF PROGRAM, AND - THE REVIEW COMMITTEE WAS ALL WOMEN, WE'RE THRILLED MANY AWARDEES ARE WOMEN AS WELL, WOMEN ARE ACTUALLY OVERREPRESENTED IN THE AWARDEES. INFORMATION ON UNDERREPRESENTED POPULATIONS WILL SHALL FORTHCOMING IN FUTURE EVALUATIONS OF THIS PROGRAM. WE FELT DR. BOGLER ADDRESSED ALL OF MY CONCERNS, AND I THINK THE COMMITTEE WAS SUPPORTIVE AND I IMAGINE WE'LL RECOMMEND CONCURRENCE OF THIS REISSUE. I'LL ASK THE OTHERS TO COMMENT. >> EILEEN OR CHERYL, ANY COMMENTS? >> THIS IS EILEEN. THIS IS A VERY EXCITING FUNDING MECHANISM AND I I THINK MICHELLE DID A FANTASTIC JOB DESCRIBING AND I'M SUPPORTIVE. THANK YOU FOR THE PRESENTATION. >> CHERYL? >> I AGREE AS WELL. THIS IS CHERYL. >> I HAD A COUPLE -- I THINK TIM WANTED TO RAISE A QUESTION. I WANTED ALSO TO ASK SOMETHING. >> IT'S A GREAT PROGRAM. NO QUESTION, OLIVER. THANKS FOR YOUR PRESENTATION. IT EXCLUDES M.D. Ph.D.s, IF YOU GO BACK TO ORIGINAL INTENT OF THE K99/R00 IT WAS NEVER INTENDED TO BE A PhD-only pipeline yet that's how it turned out to be, more than 90% of applicants and awardees are PhDs, VERY FEW MD/PHD CANDIDATES RECEIVED THESE AWARDS. I WONDER IN THE SENSE OF FAIRNESS, I MEAN, THERE'S A WHOLE GROUP OF PEOPLE THAT WE WANT TO RETAIN PHYSICIAN-SCIENTISTS INTERESTED THAT ARE NOT AVAILED OF THIS KIND OF PROGRAM. I DON'T KNOW HOW THIS PROGRAM CAN ADDRESS IT BUT SHOULD THERE BE SOMETHING PARALLEL THAT'S EQUIVALENT THAT WE DISCUSSED A FEW YEARS AGO IN THE NCI TO SEE WHETHER THERE SHOULD BE AN M.D.-ONLY K99/R00 PROGRAM. THOUGHTS? >> YOU RAISE A VERY GOOD POINT. THE CLINICIAN SCIENTISTS POPULATIONS WHO WE'RE TRYING TO SUPPORT AS MUCH AS WE CAN, SO I THINK THE POINTS YOU RAISE WE KNOW THOSE THINGS ARE TRUE AND WE WOULD -- I WOULD BE GLAD TO LOOK AT THE OPPORTUNITY TO EITHER CREATE PARALLEL MECHANISMS OR MODIFY THE CURRENT ONES TO MAKE THAT HAPPEN. I KNOW FOR THE Fs WE HAVE SEPARATE Fs FOR M.D. AND Ph.D. STUDENTS, SIMILAR IN RESPONSE TO CONCERNS ABOUT UNDERREPRESENTED MINORITIES WE DO HAVE MINORITY-DIRECTED VERSIONS OF SOME OF OUR AWARDS AS WELL SO THESE ARE THINGS THAT I WOULD BE VERY GLAD TO LOOK AT. AND I THANK YOU FOR YOUR INPUT. >> AND (INDISCERNIBLE) -- AND OTIS WANTED TO SAY SOMETHING. OTIS? OTIS? IF OTIS IS NOT COMING, KEVIN? >> DAFNA -- >> GO AHEAD, OTIS. >> OLIVER, GREAT PRESENTATION, VERY IMPORTANT PROGRAM. I THINK YOU MADE SOME COMMENTS ON HOW YOU'RE GOING TO ADDRESS UNDERREPRESENTED MINORITIES. I THINK THIS WOULD BE AN INCREDIBLE OPPORTUNITY TO ADDRESS THE ISSUE OF DIVERSITY IN THE WORKFORCE PARTICULARLY IN THE K99. I DON'T THINK IT SHOULD BE TOO DIFFICULT TO HAVE CANDIDATE TO MAKE MAYBE SPECIAL EFFORT TO GET UNDERREPRESENTED MINORITIES. YOU DID VERY WELL WITH THE WOMEN. AND THEN YOU SEE HOW THEY PROGRESS BECAUSE GOING ON TO THE NEXT PHASE IS GOING TO DEPEND UPON THEIR PERFORMANCE. BUT THIS WOULD BE AT LEAST TO GIVE THEM A CHANCE TO PROVE THEMSELF AND BE ABLE TO TAKE ADVANTAGE OF THE OPPORTUNITY. SO I THINK MORE CONCRETE, A MORE CONCRETE APPROACH TO HOW YOU'RE GOING TO DIVERSIFY THE PROGRAM. SO I RECOMMEND YOU LOOK INTO THAT TO SEE PROACTIVELY HOW YOU COULD DO THAT. >> THANK YOU FOR THAT COMMENT. WE'RE AWAITING DATA FROM THE NIH OFFICE ON THE DIVERSITY OF OUR CURRENT AWARDEES, THAT WILL INFORM OUR THINKING ABOUT WHAT COMES NEXT AND PERHAPS IF THE BOARD WILL PERMIT I COULD REACH OUT TO THE MEMBERS FOR INPUT AS WELL. THANK YOU. >> OTIS, ARE YOU ON? OKAY. KEVIN? CAN YOU UNMUTE KEVIN? >> CAN YOU HEAR ME? >> YES. >> SORRY. I HAD TWO QUICK FOLLOW-UPS. ONE IS WHEN YOU -- IT'S VERY REASSURING WOMEN ARE GETTING MORE AWARDS BECAUSE WE WORRY ABOUT NOMINATION BIAS, AND WONDERING IF YOU MIGHT CONSIDER FOR UNDERREPRESENTED MINORITIES ALLOWING INSTITUTIONS TO NOMINATE TWO, IF ONE WAS AN UNDERREPRESENTED MINORITY. AND TO FOLLOW UP ON THE COMMENT, I CAN SEE THIS IS A CHALLENGE PATH BECAUSE (INDISCERNIBLE) REASONABLE PERCENTAGE AT TOP NSTPs, MAYBE 10% GET THE SCIENCE BUG, MAYBE THEIR PARENTS WANTED THEM TO BE A DOCTOR, THEY ARE FINISHING THEIR TWO YEARS OF MED SCHOOL AND DON'T NEED THE LAST -- FIRST TWO YEARS OF GRADUATE, BUT R00 FOR THEM WOULD BE FANTASTIC. THE PROGRAM FOR NSTP PRACTICED GREATS NOT GOING INTO CLINICAL TRAINING WOULD BE AN EASY FIX FOR THIS PROGRAM WHERE THEY WOULDN'T COST YOU THE FIRST TWO YEARS, TRANSITION FROM MEDICAL SCHOOL TO POSTDOC. ONE OR TWO KIDS, YOU KNOW, EVERY TWO OR THREE YEARS THAT DO THIS ARE OFTEN AMONG OUR VERY BEST SCIENTIST, AND IT'S A REALLY GOOD OPPORTUNITY, I THINK, TO KIND OF THINK ABOUT HOW TO BE REAL CREATIVE WITH THAT POOL. >> THANK YOU FOR THAT. >> I DON'T KNOW IF YOU HAVE OTIS ON THE LINE. I'M UNABLE TO UNMUTE HIM, PAULETTE, I DON'T KNOW IF SOMEONE FROM I.T. CAN HELP HIM. OLIVER, I WANTED TO ASK WHETHER YOU'VE GIVEN THOUGHT ABOUT POSSIBLE DELAY IN THE CAREER TRAJECTORY (INDISCERNIBLE) BECAUSE OF COVID. >> OLIVER, SOMEONE NEEDS TO UNMUTE. COULD YOU HEAR MY QUESTION, OLIVER? >> YOU WERE ASKING WHAT KIND OF RESPONSES WE'RE TAKING TO THE COVID-19 SITUATION REGARDING TRAINEES? >> WELL, REGARDING THE DELAYS THAT ARE GOING TO BE CALLED FOR THESE PARTICULAR INDIVIDUALS WHO NEEDS TO KIND EVER GO THROUGH A STEEP TRAJECTORY IN ORDER TO ACHIEVE THE MILESTONE. >> NO, WE'RE ABSOLUTELY TAKING A LOOK AND COMMUNICATING WITH BLOG POSTS, NCI LEVEL, REACHING OUT TO THE COMMUNITY TO DO EVERYTHING MAXIMUM FLEXIBILITY TO ACCOMMODATE DELAYS IN CAREERS OR DEADLINES OR ANYTHING WE CAN DO, AND WE'RE ALSO ACCEPTING APPLICATION FOR EXTENSION, FOR THE TRAINEES, THEY ARE PRECIOUS, WE'RE DOING EVERYTHING WE CAN. >> THAT'S GREAT. OKAY. ANY OTHER POINTS THAT ANYBODY WANTS TO RAISE? OKAY. IF NOT, THIS IS A REISSUE. WE'RE GOING TO NOW CONTINUE WITH THE VOTING. I WOULD LIKE TO CALL FOR A MOTION. >> I WOULD RECOMMEND CONCURRENCE OF REISSUE. >> OKAY. SECOND? >> SECOND. >> I SECOND. >> FURTHER DISCUSSION? ALL RIGHT. SO WE NEED TO FIND OUT IF ANYONE WANTS TO VOTE TO CONCUR? >> (INDISCERNIBLE). >> ALL RIGHT. (INDISCERNIBLE). >> DAFNA, WE CAN'T HEAR YOU. YOU'RE BREAKING UP. >> ALL I SAID WAS THE NEXT CONCEPT IS A 10-MINUTE BREAK. >> CAN WE MAKE THAT 15 MINUTES? I THINK WE NEED TO STRETCH. >> OKAY. >> DID WE TAKE A VOTE? >> NO. WE'LL RETURN IN 15 MINUTES. >> ALL RIGHT. GOOD. >> SEE YOU ALL AT 3:30, RIGHT? >> RIGHT. THAT'S 3:30. >> OKAY. >> NEXT SMALL BUSINESS TRANSITION GRANTS, DR. CORY HALLETT IS PRESENTING. CORY? >> THANK YOU. THANKS FOR THE OPPORTUNITY TO PRESENT TODAY. I'M GOING TO PRESENT THIS NEW RFA CONCEPT, SMALL BUSINESS TRANSITION GRANT. NEXT SLIDE PLEASE. SO THE PURPOSE OF THE SMALL BUSINESS TRANSITION GRANT IS REALLY AN ENTREPRENEURIAL TRAINING GRANT THAT'S MODELS AFTER THE K99/R00, AND INCREASINGLY WE SEE IN OUR PORTFOLIO JUNIOR SCIENTISTS THAT ARE TRANSITIONING TO ENTREPRENEUR, AND THERE REALLY IS NOT A TRANSITION GRANT TO HELP THEM MAKE THIS LEAP. THERE ARE RESTRICTIONS. A K99 IS A SMALL BUSINESS GRANT DOES NOT EXIST, THERE ARE RESTRICTIONS ON HOW FUNDS ARE SPENT BECAUSE IT'S NEW DATA PROGRAM SO WE'VE CREATED STTR TO SBIR HYBRID TO ACCOMPLISH THE SAME GOALS AT K99/R00. WHEN WE LOOK AT MOST SUCCESSFUL P.I.s, WE SEE THAT EXPERIENCED NIH INVESTIGATORS DEFINED AS INVESTIGATORS THAT HAVE RECEIVED R01 OR EQUIVALENT FUNDING OR AWARD THAT'S EQUIVALENT ARE THE MOST SUCCESSFUL AT RECEIVING SBIR AND STTR FUNDING ESPECIALLY FIVE TO TEN YEARS FOLLOWING TERMINAL DEGREE. A CHALLENGE IS THE GROUP OFTEN DISCOURAGED FROM OVERSEEING SMALL BUSINESS GRANTS BECAUSE THEY ARE -- IT'S AN IMPORTANT TIME IN THEIR ACADEMIC CAREER, AND SO EITHER THEY ARE DISCOURAGED OR DON'T WANT TO TAKE THE TIME AWAY TO OVERSEE A SMALL BUSINESS GRANT. NEXT SLIDE PLEASE. WE TALKED TO A SERIES OF ACADEMIC INNOVATION OFFICES, AND LAST YEAR, EARLY THIS YEAR, HOW WE STRUCTURED THIS WE TALKED TO 62 OF THE 70 NCI DESIGNATED CANCER CENTERS OR SERVING INSTITUTIONS AND TARGETED PERSON OR OFFICE A CANCER RESEARCHER WOULD REACH OUT TO IF THEY HAD A TECHNOLOGY TO SPIN INTO A SMALL BUSINESS OR TO MOVE INTO THE COMMERCIAL SECTOR IN SOME WAY. WE TALKED ABOUT HOW THEY SUPPORT ACADEMIC INNOVATION, WHAT CHALLENGES ARE, WHAT OPPORTUNITIES, WE HAD A WORKSHOP THIS YEAR RIGHT BEFORE EVERYTHING SORT OF -- EVERYONE STOPPED TRAVELING, THEY TALKED ABOUT POST DOCS MOVING WITH TECHNOLOGY TO A SMALL BUSINESS. THIS DOESN'T MEAN THAT THE POSTDOCS ARE OWNS A LARGE SHARE OF THE BUSINESS OR THEY ARE RUNNING THE BUSINESS AS CEO BUT MORE AN MORE POSTDOCS ARE MOVING WITH THE TECHNOLOGY, OVERSEEING TECHNOLOGY DEVELOPMENT IN THIS SMALL BUSINESS SETTING. AND ALSO SOMETHING THAT WAS CITED A LOT AS A BIG NEED WAS A NEED FOR MORE SCIENTISTS WITH BUSINESS EXPERIENCE TO MOVE WITH TECHNOLOGY OUT OF THE ACADEMIC SETTING INTO THE SMALL BUSINESS SETTING. SO WE HAD BEEN ASKING IF THERE'S A WAY TO SUPPORT TRAINING GRANTS AND FACULTY BUT WE'RE ABLE TO REFINE CONCEPTS. NEXT SLIDE PLEASE. THIS IS A HIGH LEVEL OVERVIEW, PHASE 1 AND PHASE 2, NOT CLINICAL TRIAL PHASES, JUST HOW GRANTS ARE STRUCTURED. THERE'S A FAST TRACK, COMBINED PHASE 1 AND PHASE 2. SBIR OR STTR. FAST TRACK MECHANISM IS A TRANSITION MECHANISM ALREADY AND SO THAT'S WHY WE THINK THAT'S THE RIGHT SYSTEM TO USE HERE AS WE'RE HELPING TRANSITION FROM ACADEMIA OR BRIDGE FROM ACADEMIA TO THE SMALL BUSINESS. STTR PROGRAM IS DESIGNED FOR HIGH ACADEMIC INVOLVEMENT, REQUIRES COLLABORATION WITH A UNIVERSITY, SOMETHING THAT'S IMPORTANT HERE, PRIMARY EMPLOYMENT IS NOT MANDATED, THE P.I. CAN STILL BE AT THE UNIVERSITY AND BE EMPLOYED BY THE UNIVERSITY, 12 MONTHS, MAX $400,000, FEASIBILITY IN ACADEMIC SETTING, TRANSITION TO PHASE 2. SBIR PROGRAM PROVIDES COLLABORATION WITH THE UNIVERSITY, LIMITED COMPARED TO STTR. WE SEE TRANSITION GOING TO SMALL BUSINESS AND REALLY CRITICAL TRANSITION IS P.I. MUST BE EMPLOYED, MAJORITY SMALL BUSINESS UNDER SBIR SO THEY WOULD MOVE WITH TECHNOLOGY, EMPLOYMENT WITH THE SMALL BUSINESS, TWO YEARS, UP TO $2 MILLION. NEXT SLIDE PLEASE. THIS IS MORE DETAIL HOW THE AWARD WOULD LOOK. THERE WOULD BE TWO COMPONENTS LIKE A K99 SO TRAINING AND TECHNICAL COMPONENT, THE P.I. WOULD BE THE POSTDOC OR JUNIOR SCIENTIST THAT'S GOING TO TRANSITION OUT OF THE ACADEMIC SETTING INTO THE SMALL BUSINESS. MENTORING PLAN REQUIRED WITH A TECHNICAL MENTOR, IDEALLY LAB HEAD FROM WHOSE LAB THE TECHNOLOGY IS COMING FROM. AND THERE WOULD BE A BUSINESS MENTOR TO HELP THE P.I. UNDERSTAND APPROPRIATE MILESTONES TO MOVE FORWARD FOR THE COMMERCIAL SECTOR. RESEARCH STRATEGY UNDER TECHNICAL PLAN, A LOT OF THIS WORK CARRIED OUT IN THE ACADEMIC SETTING, AND THE P.I., POSTDOC P.I. WOULD PREPARE TO MOVE TO THE SMALL BUSINESS, THE TEAM WOULD NEED TO COMPLETE I-CORPS AT NIH TO LAY OUT TECHNICAL PATH FOR THE RIGHT MARKET. TO TRANSITION UNIQUE CRITERIA FOR THIS MECHANISM TO MOVE TO BE THE P.I. MOVE EMPLOYMENT FROM UNIVERSITY TO THE SMALL BUSINESS. TECHNICAL UPDATES ARE PART OF THE FAST TRACK, THEY WOULD HAVE TO DEMONSTRATE THEY MET R&D MILESTONES AND UPDATE COMMERCIALIZATION PLAN, THEY ARE NOT COMMERCIAL MARKET, AND A LITTLE BIT UNIQUE TO THIS, I'M SORRY, SOMEONE'S CHAT POPPED UP. THERE WE GO. UNIQUE TO THIS IS WE WOULD REQUIRE AN UPDATED I.P. AGREEMENT DEMONSTRATING UNIVERSITY SUPPORTS THIS TECHNOLOGY MOVING INTO THE SMALL BUSINESS OR CONTINUOUS DEVELOPMENT IN SMALL BUSINESS BECAUSE WE THINK THAT'S CRITICAL TO TECHNOLOGY SUCCESS. UNDER THE PHASE 2 SBIR THERE WOULD BE A TRAINING COMPONENT, IT'S NOT ENDING AT PHASE 1. THIS IS NON-TRANSFERABLE, IT WOULD HAVE TO BE THE SAME P.I., AWARD TIED TO THE P.I. IN THIS CASE. MENTORING WOULD CONTINUE, TYPE AND FREQUENCY, RELATIONSHIPS MIGHT CHANGE BECAUSE YOU HAVE A BUSINESS TEAM TO ASSEMBLE, BUT IT WOULD NEED TO BE SORT OF PREDICTED IN THE ORIGINAL APPLICATION. AND THEN UNDER RESEARCH STRATEGY, TECHNICAL COMPONENT, MOST OF THE RESEARCH CONDUCTED AT SMALL BUSINESS SITE. BECAUSE RESEARCH STRATEGY WOULD HAVE BEEN PEER REVIEWED GOING INTO PHASE 1, SMALL BUSINESS ALLOWED WITH NO MAJOR SCOPE CHANGES. NEXT SLIDE PLEASE. JUST QUICKLY ON CRITICAL COMPONENTS, P.I.s, BECAUSE WE'RE TARGETING JUNIOR SCIENTISTS WOULD REQUIRE THEM TO BE NO MORE THAN EIGHT YEARS FROM TERMINAL DEGREE, A GOOD PROGRAM FOR WOMEN AND SCIENTISTS FROM UNDERREPRESENTED GROUPS, SO WE WOULD ENCOURAGE THOSE GROUPS TO APPLY. IT'S A GREAT OPPORTUNITY FOR UNDERREPRESENTED GEOGRAPHIES. FOR MENTORING, IT WOULD BE SPECIAL REVIEW CRITERIA HERE, WE WANT TO WORK WITH NCI CENTER FOR CANCER TRAINING AND WE'VE SPOKEN WITH THEM AND THEY HAVE EXPRESSED INTEREST IN WORKING WITH US, REALLY EXCITED ABOUT THAT COLLABORATION BECAUSE WE WANT TO LEARN -- THEY HAVE THE REAL DEEP KNOWLEDGE ON THE K99/R00 TO MAKE THIS A SUCCESS. TECHNICAL MENTORING COMMITMENT, THIS IS SOMETHING THAT CAME UP IN THE SUBCOMMITTEE, AND WE WOULD REQUEST OR REQUIRE I GUESS MENTORS HAVE NO MORE THAN ONE MENTEE SIMULTANEOUSLY TO HAVE THESE AWARDS BECAUSE IT SHOULD BE A FAIRLY SIGNIFICANT TIME COMMITMENT. AND THE BUSINESS MENTOR, THE P.I., POSTDOC P.I.s ON THESE AWARDS COULD UTILIZE MENTORING PROGRAMS AT A UNIVERSITY, IF IT WAS TEAM-BASED, FOR EXAMPLE, THEY WOULD NEED TO IDENTIFY LEAD MENTOR. WE EXPECT MENTORS TO HAVE A COMMITMENT OF TWO HOURS A WEEK AND AS I MENTIONED IN A PREVIOUS SLIDE COMPLETE I-CORPS. NEXT SLIDE PLEASE. SO, HERE TECHNOLOGY DEVELOPMENT IS CRITICAL. WE WOULD REQUIRE THAT THEY HAVE Go/NoGo CRITERIA WITH MILESTONES SO WE KNOW THE TECHNOLOGY IS PROCEEDING AT THE END OF PHASE 1 TO TRANSITION TO PHASE 2 AND WE'RE NOT GUARANTEEING TRAINING SUPPORT TO TRANEEES WHO WHOSE TECHNOLOGY FAILS. WE ARE REQUESTING PEER REVIEW. THIS IS NOT A PILOT RFA, SET-ASIDE FUNDS, BUT CRITICAL THING IS WE THINK COMMERCIALIZATION EXPERTISE ON THE REVIEW PANEL IS IMPORTANT AND WE'VE SEEN NCI DIVISION OF EXTRAMURAL ACTIVITIES IS PARTICULARLY GOOD AT COMMERCIALIZATION EXPERTISE ON PANELS, SO WE THINK THAT'S THE RIGHT PLACE FOR PEER REVIEW AND WE THINK BECAUSE THIS IS A NEW MECHANISM AND NEW CONCEPT BRIDGING TWO FUNDING MECHANISMS, AND TO INCORPORATE COLLABORATION WITH NCI CENTER FOR CANCER TRAINING, NCI DEI IS THE RIGHT PLACE. WE'RE ASKING TWO-YEAR PILOT, FIVE TO SEVEN AWARDS. THANK YOU. I WILL TAKE QUESTIONS. >> OKAY. THANK YOU VERY MUCH, KORY. IT'S OPEN FOR REVIEW BY THE GROUP THAT REVIEWED IT. >> FIRST OF ALL, THE GROUP HAD A LOT OF GREAT COMMENTS. WE LOOKED AT THIS, THIS IS A NEW CONCEPT. I'M GOING TO ADDRESS SOME OF THE QUESTIONS THAT POPPED UP BECAUSE THERE'S NOT COMPLETE UNDERSTANDING OF WHAT THIS MEANT TO DO. I THINK THE FIRST THING WE ALL HAVE TO DO IS TAKE A STEP BACK AND REALIZE NOT EVERY SINGLE PERSON THAT'S BEING TRAINED IN THE LABORATORY IS GOING TO BECOME A FACULTY MEMBER IN A UNIVERSITIES AND BE ABLE TO FUND THEMSELVES LONG TERM. WE ALL HAVE TO REALIZE THAT GOING THE COMMERCIAL ROUTE IS AN IMPORTANT -- A VERY IMPORTANT ROUTE PEOPLE CAN TAKE ALLOWS TECHNOLOGY, OUR GOAL, TO BECOME COMMERCIALIZED. ANY PROGRAM THAT CAN FACILITATE THAT IS IMPORTANT. ON A PERSONAL LEVEL HAVING STARTED SEVERAL COMPANIES THIS TRANSITION POINT IS VERY IMPORTANT BECAUSE WHAT GENERALLY HAPPENS IS THAT THERE MAY BE TECHNOLOGY THAT'S KIND OF STARTING TO BUBBLE UP IN SOMEBODY'S LABORATORY, BUT IT NEEDS MORE WORK TO REALLY BE ABLE TO HAVE COMMERCIAL POTENTIAL, WHETHER A DIAGNOSTIC OR A DRUG OR SOMETHING ELSE. I THINK WHAT'S IMPORTANT TO REALIZE IS THAT IT'S HARD FOR SOMEBODY TO JUST STEP UP AND TAKE RESPONSIBILITY. THE P.I., PEOPLE THAT WE'RE USED TO THINKING OF TAKING THE LEAD, VERY UNLIKELY AS WE'VE HEARD TO STEP OUT AND START A COMPANY BY THEMSELVES AND LEAVE THEIR ACADEMIC CAREER. ONE OF THESE POSTDOCS MAY WANT TO TAKE THIS TECHNOLOGY, MOVE IT FORWARD TO THE NEXT STEP. THE NEXT STEP THEN, YOU KNOW, ALLOWS THEM TO BE ABLE TO EVENTUALLY DO WORK WITHIN A COMPANY, PROBABLY CHIEF SCIENTIST TO START A PRODUCT GOING SO ATTRACT INVESTMENT. FROM THE COMMITTEE AND PERSONAL POINT OF VIEW, TRANSITION POINT IS RISKY, ALLOWING PEOPLE THAT WANT TO GO COMMERCIAL TRACK THE OPPORTUNITY TO TRANSITION AND GET INTO INDUSTRY WITH SOME SUPPORT IS VERY IMPORTANT. BUT BEYOND THE FINANCIAL SUPPORT, THE MOST IMPORTANT THING IS TO BE ABLE TO HAVE MENTORS THAT CAN HELP YOU DO THAT. THAT BECOMES TRICKY, BECAUSE THERE IS THE SCIENTIFIC PART WHERE YOUR NATURAL MENTOR IS ESSENTIALLY THE FACULTY MEMBER THAT IS THE P.I. OF MOST OF THE GRANTS IN THAT LAB. AND SO THEY CAN HELP YOU ON THE SCIENTIFIC SIDE, BUT YOU NEED TO HAVE REALLY THE MENTOR THAT HIS BUSINESS EXPERIENCE TO HELP YOU BE ABLE TO TRANSITION TO COMMERCIAL MILESTONES, TO BE ABLE TO MOVE THE PRODUCT OR DEVICE FORWARD AND ATTRACT FUNDING IN THE SBIR/STTR PROGRAM AS WELL AS FUTURE FUNDING, WHICH EVER WAY YOU MAY GO. IT'S BEEN THOUGHT OUT. CLEARLY THERE'S BEEN A LOT OF THOUGHT GIVEN TO THIS. THE TWO MENTORS MADE A LOT OF SENSE, WHAT THE COMMITTEE DELVES INTO IS ACCESS ACROSS THE U.S., WANTED TO MAKE SURE THAT ALL THESE INSTITUTIONS, NOT ONLY DO THEY HAVE PEOPLE THAT WERE INTERESTED WHICH WAS CLEARLY THE CASE IN TERMS OF STEPPING OUT OF THE LABORATORY IN THIS ROUND BUT IN TERMS OF MENTORSHIP, ACROSS THE BOARD EVEN SMALLER CENTERS THERE WAS PLENTY OF ENTREPRENEURS STEPPING UP AND INTERESTED IN POTENTIALLY BEING MENTORS. SO THOSE INSTITUTIONS FELT THEY WOULD HAVE THOSE MENTORS AVAILABLE. THE OTHER ISSUE THAT WAS BROUGHT UP, THIS IS AGAIN ON PERSONAL EXPERIENCE, IT WAS REFLECTED NOW IN THE COMMENTS YOU HEARD, THIS IS A TREMENDOUS TIME COMMITMENT TO TAKE A POSTDOC AND NOT ONLY MOVE THEM FORWARD IN TECHNOLOGY TO BE ABLE TO REALIZE COMMERCIAL MILESTONES BUT ALSO LEARN ABOUT BUSINESS ALONG THE WAY, TAKES A LOT OF COMMITMENT FROM BOTH MENTORS, SO WHAT WE GOT HERE I THINK IS THERE'S ONLY ONE MENTOR ALLOWED TO MENTOR ONE PERSON AT A TIME. WE DON'T WANT, WHICH DOES HAPPEN, ONE MENTOR IN A LAB MENTORING THREE OR FOUR OR FIVE AT THE SAME TIME. THERE ARE COMMITTEES AND GROUPS WHO WORK TOGETHER SO WHAT CAME OUT IS FINE, NEEDS TO BE A LEAD MENTOR BUT THEY CAN WORK WITH GROUPS AVAILABLE AND RESOURCES AVAILABLE. SO WE THINK THIS IS A GREAT IDEA ON A PERSONAL LEVEL, I CAN TELL YOU AS MUCH AS THE UNITED STATES IS A GREAT ENTREPRENEURIAL COMPANY, LACKS IN TERMS PER CAPITA IN MANY OTHER COUNTRIES THAT ARE MORE ENTREPRENEURIAL, AND ONE OF THE PROBLEMS IS EXACTLY THIS ISSUE. THIS IS A VERY IMPORTANT ISSUE. AND WHAT HAPPENS IS GETTING THAT TRANSITION, GETTING THE FIRST PERSON TO CHAMPION THE TECHNOLOGY, OTHER COUNTRIES HAVE BEEN ABLE TO DO BETTER THAN THE UNITED STATES SOMETIMES AND THIS IS A GREAT ANSWER TO THAT BY PROVIDING THE RESOURCES AND EVEN THE PLAN WHICH IS PART OF THE RESOURCES WHICH IS ADDITION TO FINANCIAL PART AND MENTORING PART TO BE ABLE TO MAKE IT HAPPEN. SO WE'RE ENTHUSIASTIC. IT'S NEW. WE'LL SEE HOW IT GOES. WE DID TALK BY THE WAY ABOUT THE ISSUE OF WOMEN AND DIVERSITY AND WE BROUGHT IT UP AND IT'S A NEW PROGRAM, THERE'S GOING TO BE EMPHASIS AND HOPEFULLY WE SEE THAT AS WELL. THANK YOU. >> OKAY. THANK YOU VERY MUCH, DAVID. THE OTHER MEMBERS OF THE COMMITTEE WERE GRAHAM AND IAN. WOULD YOU LIKE TO ADD ANYTHING GRAHAM? >> NOTHING TO ADD. DAVID SUMMARIZED DISCUSSION AND ENTHUSIASM, FULLY SUPPORTIVE. >> THANK YOU, GRAHAM. >> THIS IS IAN. DAVID DID IT ELOQUENTLY. I'D LIKE TO THANK DR. HALLETT FOR TWO THINGS. NUMBER ONE, FOR YOUR DEGREE OF WORK TO GET THE SENSE OF THE INPUT FROM THE INSTITUTIONS, AND THEN YOUR RESPONSIVENESS TO OUR COMMENTS DURING THE COMMITTEE CALL. THANK YOU VERY MUCH. >> THANK YOU. THANK YOU TO THE THREE OF YOU FOR YOUR THOUGHTFUL COMMENTS AND YOUR FEEDBACK. VERY HELPFUL. >> MAX, DID YOU RAISE YOUR HAND? >> YES, THIS IS MAX. A COMMENT ON GEOGRAPHIC DIVERSITY. IN THIS PARTICULAR CASE, THERE'S A PARTICULAR NEED FOR THE GEOGRAPHIC DIVERSITY, THAT EVEN GOES BEYOND SOME OF THE OTHER DIVERSITIES THAT WE'VE TALKED ABOUT BEFORE. AND THE REASON FOR IT IS IF YOU LOOK AT ENTREPRENEURSHIP, AND WHERE VENTURE CAPITAL MONEY IS GOING, AND IF YOU COMPARE THAT TO THE NIH PORTFOLIO, OR NCI PORTFOLIO, THERE'S A TREMENDOUS DISCONNECT. THAT IS, MANY INSTITUTIONS THAT ARE NOT ON THE TWO COASTS HAVE VERY SUBSTANTIAL NCI SUPPORT BUT VERY LITTLE VENTURE MONEY GOING IN, IN COMPARISON. SO, THIS IS A POTENTIAL WAY OF EVENING THAT OUT AND TRAINING PEOPLE THAT ARE NOT JUST ON THE TWO COASTS TO DEVELOP NEW BUSINESSES THAT MAY SPREAD OUT ACROSS THE COUNTRY. THAT'S ONE POINT. THE OTHER POINT I WANTED TO ASK YOU IS THAT IN SOME OF THE OTHER TRAINING GRANTS SPECIFIED WHETHER NON-U.S. CITIZENS ARE ELIGIBLE FOR IT, THIS ONE IS MUCH MORE DIFFICULT BECAUSE ONE OF THE GOALS WE WANT TO FOSTER IS TO CREATE COMPANIES IN THIS COUNTRY. SO IN THIS CASE, I DON'T THINK IT WOULD BE PRODUCTIVE TO TRAIN PEOPLE TO START NEW BUSINESSES HAVING THEM START THEM ABROAD. SO WHAT ARE YOUR THOUGHTS THERE? >> THANK YOU FOR THE COMMENTS, GEOGRAPHIC DIVERSITY IS A HIGH INTEREST OF MINE. WE TRIED TO MAKE SURE TO REACH OUT TO IDEA STATES. SO, THE QUESTION ON NON-U.S. CITIZENSHIP, THE SBIR AND STTR PROGRAM IS REQUIRED BY LAW, SMALL BUSINESSES BE U.S. OWNED AND OPERATED, OWNED BY U.S. CITIZENS, OPERATED IN THE UNITED STATES. IF THERE'S HEAVY RESTRICTION AT THE USE OF THE SBIR AND STTR FUNDS, THERE'S ALMOST NO CIRCUMSTANCE, VERY RARE CIRCUMSTANCES THEY CAN EVEN SPEND THE MONEY, EVEN AT CONTRACT RESEARCH, MANUFACTURING, THEY CAN EVEN SPEND THE MONEY OUTSIDE THE ITS. BUT YOUR COMMENTS ON U.S. CITIZENSHIP FOR THE PRINCIPAL INVESTIGATOR ARE SPOT ON AND THEY ARE SOMETHING THAT I'M DEFINITELY GOING TO THINK ABOUT AS WE'RE PUTTING THIS TOGETHER BECAUSE THERE ISN'T A REQUIREMENT FOR U.S. CITIZENSHIP ON THE PRINCIPAL INVESTIGATOR, IF THE COMPANY IS U.S. OWNED AND OPERATED. SO THAT'S SOMETHING THAT WE DEFINITELY WANT TO CONSIDER AND THANK YOU FOR THOSE COMMENTS. >> ANDREA, YOU HAD A QUESTION. >> YES, I JUST NEED A LITTLE MORE CLARIFICATION ON THE TWO PREVIOUS COMMENTS ABOUT UNIVERSITY TO TECHNOLOGY. IT MAKES ME UNCOMFORTABLE FEELING LIKE THIS IS SUPPORTING TRANSITIONING POSTDOCS FROM ACADEMIA TO SMALL BUSINESS WHEN WE'RE HAVING A TERRIBLY DIFFICULT TIME KEEPING OUR POSTDOCS INTO UNIVERSITY ACADEMIC RESEARCH. AND SO I NEED MORE CLARIFICATION ON WHY YOU FEEL THE NCI SUPPORT, WHAT FEELS TO ME LIKE YOU'RE SUPPORTING POSTDOCS LEAVING ACADEMIA AND GOING INTO SMALL BUSINESS. >> YEAH, GREAT COMMENT. THANK YOU. SO THIS IS SOMETHING WE THOUGHT ABOUT. I MEAN, WE'RE NOT LOOKING -- THIS IS PART OF THE REASON FOR THE FIVE TO SEVEN AWARDS PER YEAR. WE'RE NOT LOOKING TO RECRUIT A WHOLE LOT OF POSTDOCS, BUT THIS IS SOMETHING THAT'S HAPPENING ANYWAY. WE SEE IT, ESPECIALLY, WELL, FROM SOME INSTITUTIONS BUT WE SEE THIS AS A PATTERN ANYWAY WHERE, YOU KNOW, IF AN INVENTION IS MADE, IT'S COMMON FOR A POSTDOC TO BE THE ONE TO LEAVE, AND THE UNIVERSITIES ARE TARGETING POSTDOCS TO BE THE ONE TO LEAVE BECAUSE THEY WANT TO PRESERVE FACULTY TIME WITH THE SPONSORED RESEARCH THAT'S GOING TO THE UNIVERSITY. THESE ARE SBIR GRANTS, GOING TO THE SMALL BUSINESS, SO WE'RE LOOKING TO SUPPORT SOMETHING THAT'S ANYWAY IN A THOUGHTFUL WAY RATHER THAN PUSH IT TO HAPPEN. WE'RE ONLY LOOKING AT A FEW AWARDS A YEAR. >> HOWARD? UNMUTE. >> YES, UNMUTE. SORRY. ARE YOU HEARING AN ECHO? >> YES. I THINK IT'S COMING FROM YOU. TRY AGAIN. >> IS THAT BETTER? >> NO, IT'S NOT. >> OKAY. I'LL PUT MY COMMENT IN THE CHAT IF THAT'S ALL RIGHT. I'M NOT SURE HOW TO FIX THIS. >> DAFNA, GO TO DEB. >> ANYBODY ELSE WOULD LIKE TO ASK A QUESTION WHILE WE'RE WAITING FOR HOWARD? KEVIN? >> DEB BRUNER WANTS TO MAKE A COMMENT. >> KEVIN? >> I CAN DEFER. >> YES. PLEASE GO AHEAD. >> I WANT TO MAKE TWO QUICK COMMENTS. I AGREE WITH THE POINT JUST MADE ABOUT THE REALITY IS THAT TALENTED POSTDOCS IN MANY PLACES ARE DOING THIS ANYWAY. I MEAN, THIS IS -- WE SEE THIS A LOT, UCSF, FACULTY MEMBERS GETTING ENGAGED AND STARTING COMPANIES, POSTDOCS BEING THE FIRST EMPLOYEE SO I THINK THIS IS A GOOD IDEA. I ALSO THINK THAT THE ACCESS TO CAPITAL AND VENTURE CAPITAL IS OBVIOUSLY GREATER ON THE COASTS, AND I THINK A PROGRAM LIKE THIS MIGHT REALLY FACILITATE THESE OPPORTUNITIES IN STATES THAT DON'T HAVE A LOT OF VENTURE CAPITAL SO WHAT MAX SAID, I DO THINK THAT THIS PROGRAM ACTUALLY COULD IN A WAY BE DEMOCRATIC IN TERMS OF SPREADING OUT WHERE NEW COMPANIES ARE BEING STARTED AROUND THE COUNTRY AND NOT JUST IN THE BAY AREA IN BOSTON. I ACTUALLY THINK IT'S A REALLY GOOD IDEA TO TRY IT AS A PILOT. >> GREAT. THANK YOU. AND THAT WAS EXPRESSED BY THE SUBCOMMITTEE ALSO AND SO IN LISTENING TO THAT, CONCERNS HERE, WE HAD DISCUSSED INTERNALLY WE CAN PUT A PORTFOLIO BALANCE CLAUSE INTO THE RFA SO WE DON'T HAVE ALL THE AWARDS GOING TO THE COASTS, RIGHT? THAT WE CAN MANAGE THAT A LITTLE BIT. >> OKAY. THERE WAS A SUGGESTION, HOWARD, IF YOU CAN HEAR, SOMEONE SUGGESTED YOU CAN TURN OFF YOUR PHONE IF IT'S IN THE VICINITIES OF YOUR COMPUTER IT MIGHT CONTRIBUTE TO BACKGROUND NOISE. CAN YOU TRY AGAIN? I'M GOING TO UNMUTE YOU NOW. >> IS THAT BETTER? >> NO. WE STILL HAVE ECHO. ALL RIGHT. JUST SEND YOUR QUESTIONS. ANDREA, YOU HAD ANOTHER QUESTION? >> I JUST WANTED TO CLARIFY AS A PILOT, WHAT WOULD BE THE MEASURES OF SUCCESS OR FAILURE? >> YEAH, MEASURING SUCCESS IN SMALL BUSINESS IS REALLY TOUGH BECAUSE OF THE HIGH FAILURE RATE OF THE TECHNOLOGY, BUT SO GENERALLY WE HAVE A FEW MEASURES. WE'LL LOOK AT THE MENTORING TEAM, SO AS THESE TEAMS GO THROUGH I-CORPS WE'LL BE ABLE TO LOOK AT THE MENTORING TEAM AND HAVE SOME SORT OF SCORING ON THE MENTORING BUT COMING OUT OF THE PHASE 2 WE HAVE A NUMBER OF SORT OF INTERMEDIATE COMMERCIALIZATION PATH METRICS, TO DEMONSTRATE TECHNOLOGY IS STILL PROCEEDING TO COMMERCIALIZATION, WE SPEND A LOT OF TIME WORKING IN THIS SPACE. AND SO THINGS LIKE ENTERING A CLINICAL TRIAL, RECEIVING SOME SORT OF INVESTMENT OR VENTURE CAPITAL MONEY, BEING ACQUIRED BY A LARGE COMPANY, LICENSING THE TECHNOLOGY TO ANOTHER COMPANY. SO WE SPENT A LOT OF TIME GATHERING DATA ALONG THOSE LINES AND THAT WOULD BE ALSO TRUE HERE. FOR THE SUCCESS ON THE -- BECAUSE THAT'S THE TECHNOLOGY DEVELOPMENT SUCCESS CRITERIA, FOR SUCCESS ON THE TRAINEE, IT'S A LITTLE BIT MORE DIFFICULT. WE'VE TALKED ABOUT THE CENTER FOR CANCER TRAINING. THE LIKELY -- WE WOULD BE LOOKING AT THEIR CONTINUED ROLE WITHIN THE COMPANY, THE COMPANY SURVIVES AND THEY STAY OR IF THE COMPANY IS ACQUIRED AND THEY STAY WITH IT THAT WOULD BE SUCCESS. IT'S HARDER IF THEY GO ON TO JOIN ANOTHER SMALL BUSINESS. IDEALLY IF TECHNOLOGY FAILS OR COMPANY IS ACQUIRED OR SOMETHING LIKE THAT WE SEE THEM MOVE INTO OTHER SMALL BUSINESSES BUT THOSE ARE HARDER, DEFINITELY SOMETHING WE WOULD TRY TO GATHER THOUGH. >> OKAY. SO, I THINK WE'RE PRETTY MUCH -- >> DAFNA? >> YES? >> WE'LL GIVE HOWARD ONE LAST TRY. HOWARD, TRY LOWERING YOUR SPEAKERS. >> WHILE HE'S TRYING TO DO THAT, DEB HAD WANTED TO HAVE A QUESTION. LET'S TAKE HER QUESTION AND THEN WE CAN TAKE THE VOTE IF THIS DOESN'T WORK FOR HOWARD. >> IS THAT BETTER? >> SPEAK. >> YEAH. >> HOWARD? >> IT'S HOWARD SPEAKING. IS THAT BETTER? >> YES. THAT'S MUCH BETTER. OKAY. >> OKAY. I VIEW THIS HAVING GREAT POTENTIAL. I THINK IT IS TRUE THAT OF COURSE A LOT OF PEOPLE ARE TRANSITIONING FROM ACADEMIA TO INDUSTRY, BUT IT'S CHAOTIC. AND THE CURRENT SITUATION IS A VERY HIGH FAILURE RATE. VERY LITTLE. I MEAN, STATISTICS, 20% OR LESS OF THE PROTOCOLS AND DEVELOPMENT PLANS, ESPECIALLY IN THE START-UP COMMUNITIES ARE SUCCEEDED TO MOVE FORWARD. SO, THIS I THINK BEING AN ORGANIZED AND THOUGHTFUL APPROACH COULD HAVE GREAT VALUE. I MEAN THERE COULD BE CROSSOVER LEARNING, FOR INSTANCE TO BRING PEOPLE BACK WITH TELECOMS TO SHARE LEARNING ABOUT BEST PRACTICES THAT CHAOS DOESN'T ALLOW BECAUSE MUCH SEC RULES NOT ALLOWING PEOPLE TO TALK TO OTHER COMPANIES, THERE'S A LOT OF VALUE HERE. I WOULD WONDER THOUGH ABOUT WHETHER THE METRICS OF JUST STARTING -- YOU PROBABLY THOUGHT OF THIS BUT THE METRICS OF COMPLETING THE PROTOCOLS, COMPLETING MOVING ON FROM A PHASE 1 TO A PHASE 2, WHAT WE CALL MILESTONES, OR STAGE GATES, SHOULD ALSO BE SOMETHING THAT'S INCLUDED BECAUSE IT HELPS YOU ALSO DECIDE WHETHER OR NOT LET'S SAY A WORKING PRACTICE IS REALLY GOING TO BE SUCCESSFUL, GOING FORWARD. THE SBIR, I TRIED LOOKING INTO THIS. THEY ARE GOOD AT SHELLING OUT MONEY BUT I HAVEN'T SEEN THEM REALLY FOLLOW UP WITH THE SUCCESS RATE OF REALLY INTRODUCING IMPORTANT PRODUCTS FOR THE U.S. POPULATION. >> YEAH, THANK YOU FOR THE COMMENT. A COUPLE THINGS. YOU'RE ABSOLUTELY RIGHT. FANTASTIC METRIC WE USE IS TRANSITION RATE FROM PHASE 1 TO PHASE 2 BUT WE CAN LOOK AT FOLLOW-ON FUNDING, ESPECIALLY SBIR PROGRAM, A PHASE 2B, A ONE-TO-ONE MATCH WITH A PRIVATE INVESTOR LIKE VENTURE CAPITAL TO LOOK AT AWARD WIN RATES AS INDICATION TECHNOLOGY AND P.I. IS SUCCEEDING. YOUR COMMENTS ON OUTCOMES ON SBIR PROGRAM, THERE ARE NOT MANY STUDIES. THE NATIONAL ACADEMY PUTS OUT A REPORT EVERY FEW YEARS, THE NCI, WE DID AN IMPACT ANALYSIS AND WE RELEASED THAT LAST YEAR SO IT'S ON OUR WEBSITE. AND I'M HAPPY TO SHARE IT WITH YOU. BUT WE TRIED TO TRACK DOWN MANY OF THE SUCCESSES OUT OF OUR PROGRAM AND LOOK AT IMPACT ON THE U.S. ECONOMY, SO THANK YOU FOR YOUR COMMENTS. >> DEB? >> YES, THIS IS DEB BRUNER. OVERALL I THINK IT'S A GREAT PROGRAM. THE THING THAT CONCERNS ME IS TRANSITION PHASE THAT SEEMS TO, MAYBE I'M MISUNDERSTANDING, THAT THEY ARE PRIMARILY EMPLOYED BY THE SMALL BUSINESS, HIGH FAILURE RATE, A LOT OF POSTDOCS WANT TO KEEP A FOOT IN EACH DOOR, DERAILS THE POSTDOC TO BE FORCED TO WORK IN A SMALL BUSINESS, FIVE TO SEVEN YEARS IN THE BUSINESS GOES BUST, THEY ARE NOW -- THEY HAVE LOST ACADEMIC CREDENTIALS. SO WHAT IS THE THOUGHT BEHIND FORCING THEM INTO THE SMALL BUSINESS AND NOT ALLOWING THEM TO STAY PARTIALLY IN ACADEMIA? >> YEAH, I MEAN, SO IN A SITUATION YOU DESCRIBE, THEY COULD STILL APPLY FOR AN STTR FAST TRACK AND THEY COULD KEEP THEIR EMPLOYMENT AT THE UNIVERSITY. THE THOUGHT HERE IS THAT WE WANTED TO DEMONSTRATE A COMMITMENT TO THE SMALL BUSINESS AND MAKE SURE THAT THEY WERE SERIOUS ABOUT TRANSITIONING TO ENTREPRENEUR AND THAT WAS THE REASON FOR SWITCHING FROM STTR TO SBIR. AND IN -- WE SEE MOST -- THIS IS ANECDOTAL, INTERESTING IF I DID THE ANALYSIS, BUT MOST OF THE TIME THE POSTDOCS ARE APPLYING FOR THE SBIR PROGRAM BECAUSE THEY CAN LEAVE AND GO TO THE SMALL BUSINESS, WHEREAS IF THE - FOR STTR THAT'S A LOT OF ACADEMIC P.I.s APPLYING BECAUSE THEY CAN MAINTAIN UNIVERSITY COMPONENT. >> IT WOULD BE A GOOD METRIC, ESPECIALLY FOR 80% OF BUSINESSES THAT GO UNDER. >> GREAT COMMENTS. WE STARTING TALKING WITH CENTER FOR CANCER TRAINING BECAUSE THEY ARE MUCH BETTER AT METRICS FOR TRAINING AND THAT WILL DEFINITELY -- WE'LL TRY TO INCORPORATE THAT MORE INTO OUR METRICS. >> OKAY. GREAT DISCUSSION. LET'S MOVE NOW TO VOTE. THIS IS A NEW CONCEPT, TO REMIND EVERYONE, CAN I HAVE A MOTION? >> SO MOVED. >> SECOND? >> SECOND. >> DISCUSSION? ANY DISAPPROVALS? ANY ABSTENTIONS? UNANIMOUS VOTE. >> YES, IT IS. >> OKAY. SO, THE NEXT CONCEPT IS REISSUANCE RFA COOP AGREEMENT FOR THE CANCER GENOME ATLAS NETWORK, TCGA GENOME CHARACTERIZATION AND TCGO ANALYSIS CENTER, CONCUR, REQUESTED FIVE-MINUTE PRESENTATION, THEREFORE JEAN ZENKLUSEN IS PRESENTING. JEAN. OKAY, GREAT. >> I HAVE BEEN UNMUTED. THE ANALYSIS NETWORK COULD BE VIEWED AS A CHILD OF TCGA BASICALLY, ONE OF THE THINGS THAT RESULTED FROM TCGA PROGRAM THAT ALLOWED US TO HAVE GOOD QUALITY DATA. I'D LIKE TO BEGIN WITH THE EXPERIMENT NEEDS TO BE PERFORMED USING STRICT PROTOCOL BUT ALL RESULTS HAVE TO BE DEPOSITED IN PUBLIC DATABASE AND THOSE RESULTS ARE ANALYZED BY RETAINED SCIENTISTS OUTSIDE NCI THAT DO THE PRIMARY ANALYSIS OF THE RESOURCE PRODUCES THE FIRST MANUSCRIPT AND THEN MANUSCRIPT PUBLICATION ALLOWS OTHER SCIENTISTS TO UNDERSTAND THE SCOPE OF THE RESOURCE AND THEN USE THE RESOURCE. THIS UNIQUE WAY OF DOING THINGS HAS BEEN VERY, VERY SUCCESSFUL IN TCGA, IT WAS DECIDED THAT IN THE CENTER FOR CONCEPT GENOMICS WHICH I'M PART OF ALL THE FUTURE PROJECTS OR FUTURE LARGE SCALE PROJECTS WERE GOING TO USE THIS, GUIDELINE SHOWN HERE. WE GET THE SAMPLES AND CLINICAL DATA, HOSPITALS OR CLINICAL TRIAL GROUPS. THOSE GET PROCESSED INTO ANALYTES AND CLINICAL DATA GOES TO THE GENOMIC DATA COMMONS, ANALYTES GO TO CHARACTERIZATION CENTERS AND CENTERS PRODUCE PRIMARY DATA AND ALSO DEPOSIT GENOMICS DATA COMMONS, AND ANALYSIS NETWORK WHICH IS THE PART WE'RE ASKING TO RELEASE TODAY LOOKS AT THE DATA PRODUCES REPORT AND ALL THE DATA REACHES THE RESEARCH COMMUNITY. AS I SAID, WHAT WE'RE COMING HERE TO HAVE REISSUE IS IF THIS PART HIGHLIGHTED WITH THE BIG RED CIRCLE, WHICH IS THE GENOMIC DATA ANALYSIS NETWORK. WHAT PROJECTS ARE TO BE SERVED BY THIS PIPELINE? WE HAVE PROJECTS THAT ARE RUN IN CCG, A LOT IN COLLABORATION WITH DIVISIONS, EXAMPLES LISTED HERE, ALCHEMIST, EXCEPTIONAL RESPONDERS WHICH IS ABOUT TO FINISH AND PUBLICATIONS ARE ACCEPTED. THE CLINICAL TRIALS SEQUENCING PROGRAM, WHAT THE NAME SAYS, SEQUENCES CLINICAL TRIALS THAT HAVE BEEN FINISHED, COLLABORATION WITH DCTD. CARCINOMAS OF UNKNOWN PRIMARY, REFRACTORY CANCERS, ET CETERA. THIS RESOURCE CAN BE UTILIZED BY ANY NCI PROJECT THAT USES THE CHARACTERIZATION PIPELINE DEVELOPED BY TCGA AND IT'S NOW AVAILABLE AS A SET OF CONTRACTS. SO WHAT WE'RE SAYING HERE IS GENOMIC DATA ANALYSIS NETWORK IS NOT JUST FOR USE BY CCG, BUT USED BY ALL OTHER DOCS AT NCI. IN FACT MANY OF THEM HAVE AVAILED THEMSELVES TO THEIR SERVICES, MATCH IS ONE EXAMPLE USING SOME OF THE CENTERS THAT DO ANALYSIS TO HELP THEM IN THE MANUAL SIS OR WHATEVER MODEL OF MOLECULAR ANALYSIS THEY HAVE USED. THE COMPOSITION OF THE GENOME HAS CHANGED IN THIS REQUEST, FROM PREVIOUS ONES. WE USED TO HAVE A PROCESSING CENTER, TWO VISUALIZATION CENTERS, BUT NOW GENOMICS DATA COMMONS DATABASE HAS PROGRESSED, ALL THE PROCESSING OF THE DATA HAPPENS THROUGH THE GDC, AND THAT'S, WE DON'T NEED THE PROCESSING CENTER, AND BECAUSE THE GDC PROVIDES THE COMMUNITY AT LARGE WITH A NUMBER OF VISUALIZATION TOOLS AND WE DON'T FEEL WE NEED THAT COMPONENT ANYMORE. RIGHT NOW WHAT WE ARE ASKING FOR IS THAT THE NETWORK BE MADE FROM SPECIALIZED CENTERS THAT HAVE HIGH KNOWLEDGE AND HIGH ABILITIES IN THE FOLLOWING, YOU CAN READ THEM THERE. SOME OF THEM HAVE BEEN CONSOLIDATED FROM REVIEWS (INDISCERNIBLE) ANYTHING UNDER THE PATHWAY ANALYSIS BASICALLY SINGLE-CELL SEQUENCING ANALYSIS, ANALYSIS OF CIRCULATING CELL-FREE DNA, AND CIRCULATING TUMOR DNA, LONG-READ SEQUENCES ANALYSIS, SPECIAL GENOMICS AND DIN TALENTED IMAGING ACKNOWLEDGE SIS, ALL NEW COMPETENCIES BECAUSE WE FEEL THESE TECHNOLOGIES HAVE COME OF AGE. MANY PROGRAMS NCI ARE DOING IS DOING HAVE THESE MODALITIES, SO WE NEED TO HAVE THE ABILITY TO DO THE ANALYSIS WITH NEW GROUPS THAT CAN HELP US AND HAVE THE KNOW-HOW. THE MECHANISM OF AWARDS ARE GOING TO BE U24s, AS WE HAVE BEFORE COOPERATIVE AGREEMENTS, AND WE THINK THAT WE ARE GOING TO HAVE TEN AWARDS. IT'S A MAXIMUM OF TEN AWARDS THAT WE'RE ASKING, AMOUNT PER YEAR PER AWARD HALF A MILLION DOLLARS FOR A TOTAL OF $5 MILLION PER YEAR SO TOTAL ON FIVE YEARS WOULD BE $25 MILLION. THIS IS A SIGNIFICANT REDUCTION FROM PREVIOUS ITERATIONS BECAUSE AS I SAID WE HAVE SHRUNK THE NUMBER OF GROUPS AND ALSO WE HAVE GOTTEN PROCESSING, THE MORE EXPENSIVE AWARDS. THIS IS JUST A NICE PICTURE THAT SHOWS HOW PRODUCTIVES THE GROUP HAVE BEEN. THESE ARE THE PUBLICATIONS FOR TCGA, ANYTHING FROM 2015 ON HAS BEEN DONE AND THEY HAVE BEEN A USEFUL GROUP, IT'S OBVIOUS PRODUCTION IS WITHOUT ERROR, I WILL SAY. WITH THAT, I WILL TAKE ANY QUESTIONS OR COMMENTS. >> THANK YOU, GENE. KAREN, MICHAEL AND OTIS. KAREN, WOULD YOU LIKE TO START US OFF? >> SURE, ABSOLUTELY. LET ME JUST SAY THIS WAS ABSOLUTELY A PLEASURE FOR THE SUBCOMMITTEE TO REVIEW. WE WERE UNANIMOUS IN OUR OPINION THAT THIS WAS A HIGHLY SUCCESSFUL PROGRAM WITH SUSTAINED IMPACT, FOR WHICH THERE'S A MEASURABLE HIGH RETURN ON INVESTMENT. NONE OF US HAD CONCERNS ABOUT REISSUANCE AND WE WILL RECOMMEND CONCURRENCE AND REISSUANCE OF THIS CONCEPT. MOST OF THE DISCUSSIONS THAT WE HAD AS A GROUP CENTERED AROUND FURTHER MAXIMIZING POTENTIAL. AND URGED THE GROUP TO CONSIDER REFINING OPPORTUNITIES FOR INTERACTION, INTERACTION WITH EXISTING CANCER CENTERS AND NEURODATA ANALYTICS TEAMS, AS WELL AS INCORPORATING ANYTHING THAT WE CAN FROM DIGITAL IMAGING, AS WELL AS PHENOTYPIC AND CLINICAL OUTCOME DATA. SO, I'LL STOP THERE AND LET MIKE AND OTIS OPINE BUT WE FELT THIS IS AN IMPORTANT ONE FOR THE SCIENTIFIC COMMUNITY TO SEE JUST HOW MUCH HAD COME OUT OF THIS PREVIOUS CONCEPT. >> THANK YOU, KAREN. MIKE AND OTIS, ANY ADDITIONAL COMMENTS? >> SPEECHLESS. SPEECHLESS! >> OKAY. >> COULD I MAKE A COMMENT PLEASE? >> SURE. >> SO, I HAD A QUESTION ACTUALLY, JEAN, A COMMENT ALL THOSE YEARS AGO, MOST PEOPLE WILL REMEMBER PUSHBACK FROM THE COMMUNITIES. THAT WAS THEN, THIS IS NOW. WE MADE WE MADE A COMMITMENT TO EMPOWER EVERY INVESTIGATOR. I GUESS MY COMMENT IS I THINK DOING THIS UNDER THE RUBRIC OF TCGA, ONE OF MY IF NOT MY FAVORITE PROJECT, I'M WONDERING IF JUST EMPHASIZING, JEAN, THE NEW NAME FOR THE CONSORTIUM, IS A GOOD IDEA BECAUSE I THINK YOU'RE GOING TO BRING IN SO MUCH MORE NOW THAN WE'VE HAD IN THIS -- IN TCGA BEFORE AND JUST EMPHASIZING THAT NEW APPROACH I THINK IS GOING TO BE CRITICAL. >> ABSOLUTELY. WE BASICALLY KEPT THE TCGA CONCEPT GOING BECAUSE THIS IS, AS I SAID, IT'S A CHILD OF TCGA, AND FOR THIS REISSUANCE WE'RE EMPHASIZING GENOMIC ANALYSIS DATA NETWORK, A RESULT OF TCGA BUT BEYOND. WE'RE DONE. WE'RE DOING NEW PROJECTS, INSPIRED BY TCGA, AND WE HAVE LEARNED BETTER USE OF CLINICAL DATA AND ALL OF THAT. SO I'M WITH YOU, I THINK THIS IS THE LAST REISSUANCE. NEXT TIME WE'LL ENTER IT AS A NEW CONCEPT WITH THE IDEA ANALYSIS NETWORK, WHAT WE'RE DOING, NOT TCGA. >> WHICH WE SORELY NEED, AND FUNCTIONALIZING ALL OF THIS DATA AND NOT JUST TCGA DATA WILL BECOME CRITICAL. >> ABSOLUTELY. >> THAT'S MY COMMENT. >> OKAY. CHECKING TO SEE IF WE HAVE ANYBODY ELSE IN THE CHAT BOX. I DON'T THINK SO. ANYBODY WOULD LIKE TO. >> COULDN'T HEAR YOU, DAFNA. >> (INDISCERNIBLE). >> THIS IS A REISSUE CONCEPT. WE'LL VOTE CONCUR, NOT CONCUR. LET'S START OFF WITH A MOTION. >> MOTION TO CONCUR. >> OKAY. SECOND? >> I'LL SECOND. >> ALL RIGHT. >> WE CAN'T HEAR YOU, DAFNA. >> YEAH, THERE IS BACKGROUND NOISE. THERE'S A LOT OF BACKGROUND NOISE COMING. >> DAFNA? >> YES? >> I CAN'T HEAR YOU. YOU'RE MUDDLED. >> WELL, I'M NOT DOING ANYTHING -- >> THAT'S BETTER. >> YOU'RE GOOD NOW. >> OKAY. I'M NOT GOING TO MOVE FOR THE REST OF THE CENTURY. [LAUGHTER] SO, YEAH, WE NEED TO ASK NOW WHETHER ANYONE NON-CONCURS? ALL RIGHT. ANY ABSTENTIONS? >> IT'S UNANIMOUS. >> UNANIMOUS. ALL RIGHT. THE BEST PART OF THE AFTERNOON, YOU'RE UP NOW. >> I'LL BE BRIEF. >> THE NEXT WILL BE THE PAR REISSUANCES, (INDISCERNIBLE) NEED TO DECIDE, DUE TO LARGE NUMBER OF REISSUANCES THERE WILL BE (INDISCERNIBLE) AS A GROUP, PAULETTE WILL BRIEFLY WALK US THROUGH THOSE AND I WILL CALL FOR A VOTE. COLETTE? >> OKAY. SO THERE IS A POWERPOINT. IT'S ONLY ONE PAGE. IF YOU RECALL, BASED ON THE NIH POLICY, ESTABLISHED IN 2019, OPEN FORUM BY ADVISORY COUNCIL FOR REQUEST FOR APPLICATION, RFAs, FOR NEW AND REISSUE RFPs, REQUESTS FOR PROPOSALS, FOR PROGRAM ANNOUNCEMENT SPECIAL REFERRAL AND REVIEW AND FOR PROGRAM ANNOUNCEMENTS WITH SET-ASIDES. THERE ARE NO SET-ASIDE DOLLARS FOR PARs. BSA AGREED TO RECEIVE A LIST OF PAR REISSUANCES. SPECIFICALLY, THOSE WHERE THERE ARE NO MAJOR CHANGES. WE ALSO REQUESTED THAT METRICS BE INCLUDED. FOR TODAY CONSIDERATION WILL BE GIVEN (INDISCERNIBLE) CONCURRENCE WITH REISSUANCE OF 12 PARs, LIST WAS SPENT TO THE BSA AS WELL AS NCAB MEMBERS PRIOR TO TODAY'S MEETING. I SHOULD NOTE THAT ON THIS LIST THERE ARE THREE -- PERHAPS I SHOULD SUGGEST TWO PARs, AND THOSE TWO PARs YOU WILL SEE IN THE LAST COLUMN SO THAT NO GRANTS HAVE BEEN AWARDED. THOSE TWO SPECIFICALLY THE LAST ONE WHERE YOU SEE TWO ZEROES, THOSE WILL BE INCLUDED IN TODAY'S NCAB CLOSED SESSION EN BLOC. THE EARLIER ONE WILL STILL NEED BOTH FIRST LEVEL PEER REVIEW AS WELL AS NCAB CONSIDERATION. SO ARE THERE ANY QUESTIONS? OKAY. WE DID SOMETHING ELSE TOO, I WANT TO THANK THE BSA. WE PROVIDED LINKS TO PAR REISSUANCES, WE ALSO DEVELOPED THE PROCESS SO THAT YOU COULD VOTE PRIOR TO THE MEETING, WHICH WORKS WELL. BECAUSE YOU ACTUALLY VOTED THIS TIME. THE LAST TIME WE TRIED THAT ONLY TWO OR THREE PEOPLE VOTED. BUT WE STILL HAVE TO HAVE THE VOTE IN AN OPEN MEETING. SO DAFNA, I WOULD LIKE FOR YOU TO CALL FOR THE VOTE TO CONCUR WITH REISSUANCE. DAFNA? >> OKAY. I WOULD LIKE TO ASK DOES ANYONE NOT CONCUR WITH REISSUANCE OF THE PARs? ANY ABSTENTIONS? OKAY. >> OKAY. THANKS, GUYS. >> WE'RE GOOD. THANK YOU, PAULETTE. OKAY. SO THE NEXT AND THE LAST CONCEPT FOR CONSIDERATION TODAY IS A NEW MOONSHOT PAR, CLINICAL TRANSLATION OF ACTIVATED OPTICAL FLUORESCENCE METHODS AND TECHNOLOGIES FOR SENSITIVE CANCER DETECTION IN VIVO, ROBERT NORDSTROM PRESENTING. ROB? >> THANK YOU. >> OR BOB. >> BOB IS FINE. >> SORRY. >> WHATEVER. THIS IS A MOONSHOT CONCEPT. I WANT TO EMPHASIZE THIS IS A CLINICAL TRANSLATION CONCEPT AS WELL. THE TRANSLATION OF IMPROVED IN VIVO IMAGING SENSITIVITY, GO TO THE NEXT SLIDE. THIS SHOWS MOTIVATION, AS A TUMOR GROWS, IT WILL BE BECOME THE SIZE WHERE THE MATERIAL WILL BE RELEASED INTO THE BLOODSTREAM AND DETECTED BY METHODS CALLED LIQUID BIOPSY, A FEW MILLIMETERS IN VOLUME TO OCCUR, BUT THE SIZE OF THE TUMOR MUST GROW TO CUBIC CENTS METER BUT ACCURATE LOCATION. THIS IS A WINDOW OF UNCERTAINTIES, AND CAN BE SEVERAL YEARS IN DURATION. YOU CAN SEE THE WINDOW HAS NEW RECURRENT TUMORS CAN BE INDICATED BY LIQUID BIOPSY MEASUREMENT, BUT THE LOCATION AND CHARACTERISTICS OF THE TUMOR ARE LARGELY UNKNOWN WITHOUT ANY IMAGING. LOOK AT THE NEXT SLIDE. THE GOAL THEN OF THE PROJECT IS TO REDUCE THAT WINDOW OF UNCERTAINTY BY IMPROVING IMAGING SENSITIVITY. WE WOULD LIKE TO VISUALIZE THE SMALL TUMORS THAT ARE INDICATED BY THE FLUID-BASED DIAGNOSTICS. BECAUSE THIS IS A MOONSHOT PROJECT, WE MUST CONFORM WITH THE FRAMEWORK OF THE MOONSHOT PROGRAM, IN PARTICULAR SHOWING WE CAN BOTH PROVIDE TEN YEARS OF PROGRESS IN A FIVE-YEAR WINDOW. NEXT SLIDE. THERE ARE MANY CLINICAL BENEFITS TO IMPROVE IMAGING SENSITIVITY. THE EARLY DETECTION OF SMALL TUMORS THAT WE USE AS A MOTIVATION FOR THIS IS SIMPLY ONE OF THE MANY THAT COULD BE OCCURRING. WE COULD POINT TO EARLY STAGING AND TREATMENT PLANNING, TO DETECTION OF RESIDUAL DISEASE OR METASTATIC DISEASE IN CLINICAL TRIALS. CERTAINLY WITH RESPECT TO THAT WINDOW OF UNCERTAINTY THAT I JUST MENTIONED, SENSITIVE IMAGING AND EARLY DETECTION CAN REDUCE PATIENT ANXIETY, AND THERE ARE MORE BENEFITS TO IMPROVED IMAGING. NEXT SLIDE. BRUTE FORCE WAY TO IMPROVE SENSITIVITY IS TO CREATE NOVEL DEVICES. THINGS WITH REDUCED NOISE IN THE SYSTEM, INCREASED RESOLVING POWER, SUFFICIENT FIELD OF VIEW TO GET THE JOB DONE. BUT THESE ENGINEERING ENHANCEMENTS AND DESIGN IMPROVEMENTS COST DOLLARS AND TIME, THAT'S AGAINST THE ISSUE OF MOONSHOT PROGRAM, THAT'S ATTEMPTING TO FIND SOLUTIONS TO CANCER PROBLEMS IN A SHORTER TIME AVAILABLE. WE'RE LOOKING FOR STRAIGHTFORWARD AND SIMPLE WAY TO IMPROVE SENSITIVITY, AND WE DO THAT BY INCREASING CONTRAST BETWEEN THINGS SOUGHT AND SURROUNDING. STANDARD IMAGING HARDWARE, AS AN EXAMPLE CONSIDER THE MOON DURING THE DAYLIGHT. IT'S RELATIVELY FEATURELESS, DIFFICULT TO SEE. THE MOON DOESN'T GET ANY BRIGHTER AT NIGHT. IT'S THE CONTRAST BETWEEN IT AND THE NIGHT SKY INCREASES CONSIDERABLY. GIVING US THE ABILITY TO SEE SMALL DETAILS ON THE SURFACE THAT WERE INVISIBLE BEFORE. NEXT SLIDE. MEDICAL IMAGING, THE USE OF IMAGING PROBES OR AGENTS HAS BEEN PRIMARY METHOD FOR IMPROVING IMAGING SENSITIVITY THROUGH CONTRAST ENHANCEMENT. VIRTUALLY EVERY IN VIVO MODALITY CAN BE IMPROVED THROUGH CONTRAST IMAGING, MANY ARE LISTED RIGHT HERE. EACH MODALITY IMAGING HAS IMPORTANT BUT ROLES TO PLAY IN THE CLINIC. NEXT SLIDE. IN PARTICULAR I WANT TO TALK ABOUT OPTICAL FLUORESCENCE IMAGING, SHOWING GREAT POTENTIAL AT DIAGNOSING TUMORS IN A NUMBER OF BODY LUMENS AND ORGANS, INCORPORATED INTO TODAY'S ROBOTIC SURGICAL DEVICES. ALTHOUGH SOMEWHAT RESTRICTED TO INTRALUMINAL APPLICATIONS, THERE IS A DEMONSTRATED NEED FOR HIGH SENSITIVITY IMAGING IN THESE AREAS. IN ADDITION, IT HAS KNOWN CLINICAL IMAGES, NON-IONIZING RADIATION, EYE RESOLVING POWER, LOW COST OPERATIONS LISTED HERE. FOR THIS REASONS WE'VE SELECTED OPTICAL FLUORESCENCE IMAGING, STRONG TRANSLATION POTENTIAL TO DEMONSTRATE SENSITIVE TUMOR DETECTION IN CLINICAL UTILITIES. NEXT SLIDE. SYSTEMICALLY DELIVERED PROBES WERE CONCENTRATED BECAUSE OF VASCULATURE IN THE VICINITY OF THE TUMOR. PROGRESS WAS MADE WHEN THE IMAGING AGENTS WERE CONJUGATED WITH LIGANDS SUCH AS ANTIBODIES OR PEPTIDES, TARGETING RECEPTOR MOLECULES ON THE TUMOR CELL. THESE ALWAYS ON THERMOPHORES LIMITED CONTRAST THAT COULD BE PROVIDED BETWEEN THE TUMOR AND SURROUNDING TISSUE. SO INCREASED CIRCULATION TIME NEEDED TO WASH OUT THE UNBALANCED STAGING. THE PROBLEM IS IT REQUIRES INCREASED TIME AND CONTINUE THE OPTICAL ACTIVITY. THE NEXT STEP OCCURRED IN THE 1990s, SMART PROBES, OPTICAL SWITCHES, OR ACTIVATED PROBES. ENGINEERED MOLECULES WITH ACTIVATED FLUORESCENTS CHARACTERISTICS. ONE PARTICULAR EXAMPLE, PROBES CARRIED FLUORESCENCE POINTER, CONNECTED TO FLUOROPHORE, BUT THE PEPTIDE IS BROKEN IN PRESENCE OF SURFACE ENZYMES AT TUMOR SITE CAUSING IT TO FLUORESCE. A FEW ARE SHOWN HERE. TARGETED PROBES RESULT IN CONTRAST BETWEEN THE TUMOR AND BACKGROUND TISSUE ABOUT 10:1, ACTIVATED PROBES 100:1. NEXT SLIDE. I SHOULD MENTION PROGRESS IS ALSO MADE USING NANOPARTICLES INCLUDING QUANTUM DYE. NEXT SLIDE PLEASE. IN 2003, CHALLENGES WERE DISCUSSED OF TRANSLATING INTO LIVING SUBJECTS, CONCLUDED PROSPECT OF MOLECULAR IMAGE AING IN VIVO WAS VERY PROMISING IN PART DUE TO PROGRESS MADE BY ACTIVATED PROBE. YET DESPITE THIS FACT EARLY ENTHUSIASM LITTLE TRANSLATIONAL PROGRESS HAS BEEN MADE. NEXT SLIDE. OUR PLAN COULD SOLICIT APPLICATIONS DIRECTLY INVOLVING THE TRANSLATION OF ACTIVATED FLUORESCENCE. WE WANT TO SEEK TEAMS WITH TRACK RECORDS IN ACTIVATED FLUORESCENCE RESEARCH TO REDUCE TIME SPENT, EMPHASIZING NEED TO BUILD RESEARCH CLINICAL AND IMAGE AING INPUT FROM AING IN-- IMAGING INPUT, REQUIRING CLINICAL TRIAL VALIDATION AS OUTCOME RATHER THAN PRE-CLINICAL OR DEVELOPMENT WORK. NEXT SLIDE. SO I'LL CONCLUDE BY SAYING THAT WE FEEL IT'S THE MOST RAPID MOONSHOT PROGRESS (INDISCERNIBLE) CAN BE MADE BY TRANSLATING EXISTING TECHNOLOGY RATHER THAN CREATING NEW. THE CHALLENGE THEN IS TO BRIDGE THIS GAP BETWEEN THE DEVELOPMENT ACTIVITY AND CLINICAL TESTING. THERE ARE MANY BARRIERS, A FEW ARE SHOWN HERE IN THE SLIDE. WE'RE MOTIVATED BY THE WORDS OF DR. ZERHOUNI, IT'S THE RESPONSIBILITY OF THOSE INVOLVED IN TODAY'S BIOMEDICAL RESEARCH TO TRANSLATE REMARKABLE INNOVATIONS WE'RE WITNESSING IN DEVELOPING AGENTS. TRANSLATION IS EVERY BIT AS CHALLENGING AS INITIAL DEVELOPMENT, WE'RE PROPOSING A FEW FOCUSED PROGRAMS DEALING WITH TRANSLATION, CLINICAL VALIDATION, AND WORK FLOW INTEGRATION, $5 MILLION OVER FIVE-YEAR PERIOD IS SUFFICIENT TO DEMONSTRATE THE CLINICAL TESTING AND TRANSLATION. THESE PROJECTS, WE HOPE TO SHOW HIGH CONTRAST IMAGING IN CLINICAL SETTING CAN PROVIDE SENSITIVITY THAT WILL FILL THE GAP BETWEEN THE CURRENT CLINICAL IMAGING CAPABILITIES AND FLUID-BASED DETECTION. WITH THAT I'LL TAKE QUESTIONS. >> THANK YOU VERY MUCH, BOB. AND REVIEWERS WERE DAVE AND SYLVIA AND CHRIS. DAVE, WOULD YOU LIKE TO START US OFF? >> YES, DAFNA. THANK YOU. WE MET WITH DR. NORDSTROM ONCE BY ZOOM AND THEN HAD ONE FOLLOW-UP E-MAIL, AS HE DELINEATED THE MOONSHOT GOAL IS TO TRANSLATE TECHNOLOGIES THAT ARE SHOVEL READY FOR EVALUATION IN HUMANS. AND IN HIS OPINION THE OPTICAL PROBES ARE ONE SUCH ENTITY. THERE ARE OTHER WAYS TO VISUALIZE CANCER, OF COURSE, AND EARLY ON IN OUR DISCUSSION WE PROBED WHY OPTICAL PROBES MORE SO THAN OTHER MODALITIES SUCH AS RADIO TRACERS WHICH ARE FAR MORE SENSITIVE FOR THIS APPLICATION, AND BECAUSE THAT WOULD OBVIOUSLY IMPACT WHETHER THIS IS AN INVASIVE OR NON-INVASIVE PROCEDURE, IN THE GOALS OF EARLY DETECTION AND STAGING AND PATIENT MANAGEMENT. AND DR. NORDSTROM CONSULTED WITH HIS COLLEAGUES IN HIS DIVISION, JIM DOROSHOW'S DIVISION, THEY CAME TO THE CONCLUSION SINCE THEY HAD DISCRETE AMOUNT OF MONEY, THEY HAD A COHORT OF INVESTIGATORS WHO HAVE BEEN DEVELOPING OPTICAL PROBES WHO WERE AT THAT FINAL STAGE WHERE THEY WERE READY TO TRANSLATE PRE-CLINICAL WORK INTO THE CLINIC AND WANTED TO USE THIS AS IMPETUS FOR THAT. AND SO OPTICAL PROBES ARE FASCINATING. THEY WERE DESCRIBED VERY NICELY, SIGNAL TO NOISE HAS GONE UP BECAUSE YOU HAVE SMARTER PROBES. THEY ARE RESTRICTED FOR INTRALUMINAL OR INTRAOPERATIVE PROCEDURES DUE TO PENETRANCE ISSUE. THERE ARE THERE ARE OTHERS THAT ARE STRONGER, OTHERS COULD BE EARLY DIAGNOSING ESOPHAGEAL CANCER, A COMMON PRE-MALIGNANCY, FROM BARRETTES TO INVASIVE ADENOCARCINOMA OF THE ESOPHAGUS, YOU CAN THINK OF OTHER APPLICATIONS DUE TO COLONOSCOPY WHERE THIS COULD BE USED. INTRAOPERATIVELY, IF THE SURGEON IS ABLE TO SEE SMALL MICRO METS IN THE FIELD OF VIEW, THAT COULD CHANGE THE MANAGEMENT OF PATIENTS. LOCAL RADIOTHERAPY COULD THEN BE EMPLOYED, ADDITIONAL THERAPY, PATIENTS WOULD BE STAGED DIFFERENTLY, ON CLINICAL TRIALS, ET CETERA. SO AGAIN OUR COMMITTEE, WE WANTED TO ASK WHY ONLY OPTICAL, RECEIVED THIS ANSWER BACK, ENTHUSIASTIC FOR DEVELOPING BETTER METHODOLOGIES FOR STAGING PATIENTS FOR EARLY DIAGNOSIS OR FOR MANAGEMENT. METRIC IS CLINICAL TRIAL. A BIT LIKE A SPORE PROJECT IN THAT REGARD. INVESTIGATORS HAD PRE-CLINICAL DATA, ALL THE ANIMAL MODEL WERE READY TO DO CLINICAL SCIENCE TRIALS WITH THESE AGENTS. AND SO DR. NORDSTROM TALKED TO US FOR ABOUT AN HOUR. WE ASKED OUR QUESTIONS. HE WAS ABLE TO RESPOND BACK TO THEM. THEY DID WANT TO RESTRICT THE FIRST SETTING TWO TO THREE GRANTS FOR OPTICAL PROBES AND NOT INCLUDE OTHER IMAGING MODALITIES SO I WOULDN'T CALL THIS AGAIN A NON-INVASIVE SITUATION. THIS IS INTRALUMINAL OR INTRAOPERATIVE MOST LIKELY, AND THAT'S OKAY. THERE ARE A LOT OF OTHER PATIENTS WITH PANCREAS, LARYNX CANCER, ET CETERA, THIS IS NOT GOING TO BE THE METHODOLOGY THAT THEY NEED BUT I THINK THIS IS A GOOD START. AND OVERALL WE WERE SUPPORTIVE. I THINK SYLVIA FROM OUR GROUP IS STILL HERE SO SHE WANTS TO WEIGH IN ON THIS TOO. >> SYLVIA. >> THANK YOU. DAVE DID A GREAT JOB SUMMARIZING OUR SUBCOMMITTEE DISCUSSIONS AND VIEWS. I DON'T HAVE ANYTHING TO ADD. I REMAIN SUPPORTIVE. I LIKE THE TRANSLATIONAL FOCUS, AND DESPITE THE FACT THAT IT'S RESTRICTED TO OPTICAL PROBES, I THINK THE SIZE OF THE AWARD MAKES SENSE TO KEEP IT RESTRICTIVE. THANK YOU. >> OKAY. CHRIS? IS CHRIS ON THE CALL? I DON'T THINK I'VE SEEN HIM. >> CHRIS IS NOT GOING TO MAKE THE CALL TODAY. >> NO, CHRIS IS NOT ON THE CALL. >> OKAY. ALL RIGHT. OKAY, NOW I SEE. OKAY. ANY QUESTIONS FOR DR. NORDSTROM? I HAD A QUESTION ABOUT THE SIZE OF THE (INDISCERNIBLE) LOOKS TO ME THAT WHAT (INDISCERNIBLE) PARTICULARLY WITH EMPHASIS ON TRANSLATION, I'M NOT SURE, I DON'T KNOW IF THERE WAS ANY DISCUSSION OR AN ATTEMPT TO ASSESS WHAT SOMETHING LIKE THIS COULD COST (INDISCERNIBLE) YOU WANT TO BRING IT TO THE (INDISCERNIBLE) [BACKGROUND NOISE] WONDERING ABOUT THIS SIZE OF THE AWARD. >> THE AWARDS WERE BASICALLY (INDISCERNIBLE) BY NORMAL R01 (INDISCERNIBLE) HALF A MILLION DOLLARS, WE LOOKED TO SEE (INDISCERNIBLE) TRANSLATION PROGRAMS IN OTHER AREAS AND (INDISCERNIBLE) SMALL CLINICAL TRIALS (INDISCERNIBLE) CAN BE DONE WITH THE KIND OF MONEY THAT WE'RE TALKING ABOUT. >> I DON'T KNOW, I MEAN PROBABLY WE CAN THINK OF -- [BACKGROUND NOISE] JUST AS YOU WERE DESCRIBING I WAS TRYING TO TO BACK OF THE ENVELOPE CALCULATION TO GET ANY CONCLUSION MIGHT BE ENOUGH BUT MAYBE THE APPLICANT IS GOING TO HAVE TO JUSTIFY. I'M JUST CONCERNED THAT MAYBE WE'RE GOING FOR MORE WITH LESS FUNDING, GOING WITH LESS, WITH SIGNIFICANT FUNDING TO DO THE JOB RIGHT. BUT THIS IS SOMETHING -- (INDISCERNIBLE) [BACKGROUND NOISE] >> I'M HAVING A HARD TIME UNDERSTANDING. >> THERE IS BACKGROUND NOISE. I DON'T KNOW WHERE IT'S COMING FROM. CAN EVERYBODY MUTE? OKAY. >> I WAS JUST ASKING WHETHER IT WOULD BE WORTH CONSIDERING REDUCING -- I KNOW IT'S NOT A WHOLE LOT OF AWARDS BUT REDUCING THE NUMBER OF AWARDS AND INCREASING THE SIZE OF AN INDIVIDUAL AWARD BECAUSE TO ME IT LOOKS THAT A REGULAR SIZE R01 FOR THIS TYPE OF UNDERTAKING MIGHT NOT JUST CUT IT SO WE'RE GOING TO END UP WITH MULTIPLE AWARDS THAT ARE PARTIALLY ACCOMPLISHING WHAT THEY ARE SUPPOSED TO ACCOMPLISH. SO THAT WAS JUST A THOUGHT I HAVE, MAYBE WE'LL HAVE TO REEVALUATE WHEN PEOPLE ARE SUBMITTING BUDGETS. >> THAT'S TRUE. OF COURSE WE'LL HAVE TO WAIT AND SEE WHAT COMES IN. WE'RE LOOKING TO SEE THAT THE KINDS OF DETECTION THAT CAN BE DONE IS INDEED ON THE SAME LEVEL AS THE SMALL -- SIMILAR SMALL AREA DETECTION THAT IS SEEN WITH LIQUID BIOPSY. SO WE'RE NOT NECESSARILY LOOKING FOR POWER OF A CLINICAL TRIAL AS MUCH AS WE'RE LOOKING FOR THE PROOF OF VISIBILITY OF SOME OF THESE TUMORS AS THEY APPEAR IN CLINICAL TRIALS. >> CORRECT, YEAH. JUST TO MOVE IT FROM ANECDOTAL EVIDENCE TO SOMETHING THAT YOU CAN MOVE ONTO A REAL CLINICAL TRIAL MIGHT BE A LITTLE BIT MORE (INDISCERNIBLE). >> A STEPPING STONE, RIGHT, EXACTLY. >> OKAY. ANY OTHER COMMENTS, QUESTIONS, POINTS THAT ANYBODY WANTS TO RAISE? YES? >> I WANTED TO ASK A QUESTION, SORRY, I DIDN'T SEE YOU. WHO WAS IT? >> THIS IS VICKIE. THERE HAVE BEEN A LOT OF ADVANCES MADE IN NON-CONTRAST OPTICAL IMAGING, WILL YOU CONSIDER THE INCLUSION OF THIS TECHNOLOGY OR WOULD YOU REQUIRE THE USE OF A CONTRAST AGENT? >> WE'RE TALKING ABOUT THE USE OF CONTRAST AGENTS IN THIS PARTICULAR -- ACTIVATED CONTRAST AGENT. >> YOU WOULD NOT CONSIDER LIKE PAST IMAGING OR SOMETHING LIKE THAT? >> I HADN'T THOUGHT ABOUT IT, NO. I THINK FOR THE NUMBER OF APPLICATIONS WE'RE LOOKING FOR, YOU WANT TO KEEP IT FAIRLY FOCUSED ON THE IDEA THAT WE HAVE . >> ANY OTHER THOUGHTS, POINTS? I JUST DON'T WANT TO LET YOU GO BEFORE 4:55. SO I'M JUST -- I WANT TO MAKE SURE THAT YOU'RE FULL TIME. >> I DON'T HAVE TO DO THAT, DAFNA. [LAUGHTER] >> OKAY. ALL RIGHT. SO THIS IS A -- LET ME SEE, PAULETTE. THIS IS A NEW PAR? >> YES, IT IS NEW, RIGHT. >> OKAY. ALL RIGHT. SO I WILL ASK NOW FOR SOMEONE TO CALL FOR A MOTION. THIS IS A MOTION TO APPROVE OR DISAPPROVE. >> CORRECT. >> OKAY. >> MOTION TO CONCUR. >> APPROVE OR DISAPPROVE, YEAH. MOTION TO APPROVE? >> SECOND. >> OKAY. ANY DISCUSSION? OKAY. ANY DISAPPROVALS? ANY ABSTENTIONS? >> IT'S YOUR UNANIMOUS, DAFNA. >> WONDERFUL. OKAY. SO DO WE HAVE ANY OTHER BUSINESS , PAULETTE? >> NO. YOU CAN TURN IT BACK OVER TO LIZ. LIZ, IT'S ALL YOURS. >> THANKS, DAFNA. OKAY. SO JUST TO FINISH UP THE SESSION, I HAVE JUST QUESTIONS FOR FUTURE AGENDA ITEMS. ARE THERE ANY MEMBERS HERE WHO WOULD LIKE TO BRING UP ANYTHING FOR THE FUTURE TO BE NCI LEADERSHIP? YOU CAN DO IT NOW OR YOU CAN ALSO SEND YOUR AGENDA ITEMS TO EITHER PAULETTE, MYSELF, OR DAFNA, AND WE CAN THEN DISCUSS IT WITH LEADERSHIP. >> LIZ, IT'S KEVIN. I THINK THE LAST MEETING WE HAD OF THE BSA WE TALKED A LOT ABOUT TRYING TO TAKE A LOOK AT THE NCI'S OVERALL FUNDING PORTFOLIO, HOW MUCH OF THE BUDGET GOES TO RSGs, VERSUS NON-RSG FUNDING, AND PAYLINES THAT WE'VE BEEN CONCERNED ABOUT IT. I DIDN'T WANT THAT TO GET LOST IN TERMS OF FUTURE AGENDA ITEMS FOR US. >> IT'S NOT LOST, KEVIN. PLANS ARE TO HAVE A PRESENTATION AT THE JOINT MEETING IN DECEMBER. >> THANK YOU, PAULETTE. >> ANYTHING ELSE YOU WANT TO RAISE NOW BEFORE WE CONCLUDE? I SEE SOMEONE RAISING THEIR HAND. IS THAT HOWARD? >> HELLO? >> YEAH, HI. >> HI. SOMETHING'S HAPPENING THIS YEAR THAT I THINK BEARS ON MULTIPLE PROGRAMS THAT WERE DISCUSSED TODAY, THE CLINICAL TRANSITION GRANT, THAT'S WHAT'S GOING ON WITH THE INTERNATIONAL CONFERENCE ON HARMONIZATION, ICH. SO THERE'S MULTIPLE UPDATES THAT HAVE STARTED AND BEEN RELEASED, THEY ARE LOOKING FOR ENGAGEMENT, AND ON THE CLINICAL SIDE I THINK IT'S A GREAT OPPORTUNITY TO PUT THAT ON AS AGENDA ITEM, IF NOT HERE MAYBE IN THE CLINICAL -- WHAT'S IT CALLED? CLINICAL PROTOCOL SUBGROUP IF YOU THINK THAT WOULD BE WISER. AT DIA THIS WEEK MULTIPLE PRESENTATIONS BY INDUSTRY BUT ESPECIALLY FDA AND INTERNATIONAL REGULATORS ON, NEW DATA STANDARDS FOR CLINICAL PROTOCOLS. WHAT'S IMPORTANT, THESE ARE ALREADY BEING ENDORSED INTERNATIONALLY, FOR RARE TUMORS, WE NEED INTERNATIONAL ENROLLMENT TO ACHIEVE THINGS FOR THE U.S. POPULATION. SO THERE'S A LOT OF VALUE I THINK FOR US UNDERSTANDING BETTER WHAT THESE MEAN, WHAT IMPLICATIONS ARE FOR THE CANCER CLINICAL PROTOCOL ENTERPRISE, AND COMMUNITY. AND THE QUALITY ISSUES THAT ARE PART OF IT. >> OKAY. SO WE'LL PUT THAT ON (INDISCERNIBLE). >> YEAH, I THINK WHAT HOWARD IS PROPOSING IS SOMETHING THAT PERHAPS THE CLINICAL TRIALS SUBCOMMITTEE, NCAB SUBCOMMITTEE CAN ADDRESS. AND THEN IT CAN (INDISCERNIBLE) NCI LEADERSHIP, WE'RE GOING TO RECONSTITUTE, NOW THAT WE HAVE NEW MEMBERS AND ET CETERA, SOMETIME AFTER TODAY'S MEETING. OKAY? OKAY. >> THANKS, PAULETTE. ANYONE ELSE HAVE ANYTHING THEY WANT TO BRING UP? YES, I SEE SYLVIA. >> SO, BEFORE WE WERE TALKING ABOUT THE PARs, I TRIED TO SPEAK UP BUT MY INTERNET SORT OF GAVE UP ON ME. I WOULD REALLY LIKE TO UNDERSTAND WHY THE NUMBER OF R25s DECREASED SO MUCH. WHEN LOOKING AT THE PARs FOR THE R25s, EDUCATION RESEARCH AWARDS, THEY WENT DOWN FROM LIKE HUNDREDS TO TENS. SO-- >> I THINK, LIZ, DO YOU WANT TO RESPOND? OR DINAH PERHAPS? >> MAYBE DINAH COULD. I WILL SAY THIS IS ONE OF THE TOPICS TO GO THROUGH BY . CANCER CENTERS, CLINICAL TRIALS, R25s, FOR EXAMPLE, THAT'S ON THE DOCKET, AS PAULETTE ALLUDED TO EARLIER. SO WE WILL BRING A MORE THOROUGH DESCRIPTION WHY THAT OCCURRED UNLESS DINAH CAN ANSWER RIGHT NOW. >> I THINK WE'RE JUST REVIEWING WITH ALL OF OUR -- THE OVERALL COMPOSITION OF ALL OF OUR TRAINING PROGRAMS. THERE HAS BEEN INCREASING EMPHASIS ON INDIVIDUAL AWARDS, AS OPPOSED TO LARGE TRAINING GRANTS, THAT MAY ACCOUNT FOR SOME OF THE SHIFT. BUT AS I SAID WE'RE GOING THROUGH RIGHT NOW AND LOOKING AT THE DATA AND PLAN TO BRING IT BACK TO THE COMBINED BOARDS IN DECEMBER. >> I WOULD LIKE TO ADD AS YOU CONSIDER ONE THING THAT'S NICE ABOUT THESE AWARDS, BESIDES INDIVIDUAL AWARDS, THEY CREATE COMMUNITIES. AND SO THESE POSTDOCS ARE PART OF A PROGRAM AND CREATE A COHORT, SO IT'S SOMETHING TO KEEP IN MIND AS YOU THINK THIS THROUGH. >> THANKS. >> ANY OTHER SUGGESTIONS, COMMENTS? OKAY. IF NOT, THIS CONCLUDES THE OPEN SESSION. WE'LL HAVE A 10-MINUTE BREAK FOR NCAB MEMBERS AND DESIGNATED NCI STAFF WHO WILL MEET TO RETURN. OTHERWISE EVERYONE ELSE CAN SIGN OFF. THOSE ATTENDING THE CLOSED SESSION YOU NEED TO SIGN BACK ON WITHIN THE NEXT TEN MINUTES USING THE NEW WEBEX CONNECTION INFORMATION THAT WAS JUST SENT TO YOU IN THE PAST HALF HOUR. THANK YOU FOR A WONDERFUL SESSION. EVERYONE, PLEASE BE SAFE AND HAVE A WONDERFUL SUMMER. THANK YOU. >> THANKS, EVERYONE, WHO IS NOT MAKING THE CLOSED SESSION.