WELCOME TO MEMBERS OF THE BOARD OF SCIENTIFIC ADVISORS, NCI STAFF AND VIEWERS. BEFORE WE BEGIN THERE'S SOME HOUSEKEEPING THINGS I NEED TO REMIND OF YOU. THOSE WHO WISH TO EXPRESS VIEWS FOR ANY ITEMS DISCUSSED DURING THE MEETING CAN WRITE TO THE EXECUTIVE SECRETARY OF THE BOARD WITHIN 10 DAYS OF THE MEETING. ANY WRITTEN COMMENTS WILL RECEIVE CAREFUL CONSIDERATION. AS BOARD MEMBERS, I WANT TO REMIND YOU MUST WITHDRAW YOURSELVES IN CERTAIN PARTICIPATIONS IN A PARTICULAR PRODUCT, PROGRAM OR OTHER SPECIFIC MANNER WHO CONSTITUTE A CONFLICT OF CONSIDER OR THE APPEARANCE OF ONE. IT'S INCUMBENT ON YOU TO ABSTAIN ON ANY PARTICIPATION IN DISCUSSION OR ACTION REGARDING THAT MATTER. IN LIGHT OF POLICIES GOVERNING CONFLICT OF INTEREST BASED ON FINANCIAL HOLDING OF SPECIAL GOVERNMENT EMPLOYEE, WHICH INCLUDES ALL MEMBERS, WE MUST DEPEND ON YOU TO VOLUNTARILY ABSENT YOURSELF DURING ANY AND ALL DISCUSSIONS OF MATTERS THAT COULD CONCEIVABLY IMPACT THE STATUS OF THOSE HOLDINGS. WE TRUST YOUR JUDGMENT IN THESE INSTANCES. FUTURE METER DATSDZ -- DATES ARE ON THE AGENDA AND MAY I HAVE A MOTION FOR THE 2022 DATES. >> SO MOVED. >> CAN I HAVE A SECOND? >> SECOND. >> ANY DISCUSSION? >> SO WE'LL VOTE NOW. ANY FOR NAY? ANY ABSTENTIONS? THE MOTION CARRIES. THERE ARE NO MINUTES FOR APPROVAL AT THIS MEETING THOSE WHO JOINED WERE APPROVED BY THE NCAB AT THE FEBRUARY 2021 VIRTUAL MEETING. A COPY WAS SENT TO YOU AND THE MINUTES HAVE BEEN POSTED. A QUORUM OF BOARD MEMBERS IS REQUIRED FOR EACH INSTANCE IN WHICH A VOTE MAY OCCUR WHETHER IN OPEN OR CLOSED SESSION. DURING THIS MEETING THE MINIMUM OF 14 APPOINTED MEMBERS MUST BE PRESENT TO VOICE THEIR VOTES AND SINCE WE CAN'T PREDICT THE TIME NOR THE OCCURRENCE OF ANY MOTION YOUR PRESENCE IN THE VIRTUAL ROOM FOR ALL SEGMENTS OF THE MEETING IS REQUIRED. AND BEFORE I TURN THE MEETING OVER TO FOR OUR FIRST AGENDA ITEM I WANT TO RECOGNIZE WITH ALL OF YOU WE'RE COMING UP ON A YEAR SINCE OUR FIRST VIRTUAL MEETING SINCE THE COVID MOSTLY CLOUDY -- COVID SYMPTOMS STARTED AND I WANT TO RECOGNIZE JOY AND RI RICARDO FOR HELPING US ADJUST AND ADOPT TO THE NEW NORMAL. IT'S BEEN A HER OBIC EFFORT AND WE COULDN'T -- HEROIC EFFORT AND COULDN'T HAVE CONTINUED WITHOUT YOUR HELP OR NCI STAFF. WITH THAT I'LL TURN IT OVER TO NEED TO GIVE THE DIRECTOR REPORT. >> THANK YOU. GOOD AFTERNOON, EVERYONE. I APPRECIATE THE MANAGEMENT AND HANDLING OF THE ISSUES RUNNING THE VIRTUAL BOARD DURING THE PANDEMIC BECAUSE IT'S ONE OF THE UNTOLD STORIES HOW THE NCI HAS WRITTEN TO THE CHALLENGE AND I DON'T THINK WE SKIPPED A BEAT TO THANK YOU FOR POINTING THAT OUT. I THOUGHT I'D QUICKLY GO THROUGH SUBJECTS AND HAVE TIME AT THE END FOR QUESTION. THERE'S A LOT TO DISCUSS. I'LL PRESS ON. HERE'S A QUICK LOOK AT THE AGENDA AND THOUGHT I'D SAY SOMETHING ABOUT THE EFFORT AT NY NCI AND MOON SHOT AND CANCER INITIATIVE AND NCI APPROPRIATIONS AND PAY LINES AND COVID AND RESEARCH AND WE'LL HAVE MORE DETAIL ABOUT THE ADMINISTRATION'S NEW INTEREST IN CANCER RESEARCH WHICH I THINK IS EXCITING. ANOTHER THING TO SAY IS THOUGH ON THE FIRST ANNIVERSARY OF THE PANDEMIC IT'S BEEN A STRANGE AND TUMULTUOUS YEAR FOR CANCER RESEARCH AND A PRODUCTIVE YEAR. 2020 LED TO A LOT OF IMPORTANT ADVANC ADVANCES AND FOR THE RESEARCH AS A WHOLE. WE'RE A LITTLE MORE THAN A MONTH IN THE NEW ADMINISTRATION OR CLOSING IN ON TWO MONTHS AND WE'VE SEEN INTENSE INTEREST FROM THE NEW ADMINISTRATION IN CANCER RESEARCH. THIS WAS A VIRTUAL MEETING FROM THE FIRST LADY IN FEBRUARY AND HAD A VISIT TO THE CANCER CENTER I WENT TO VISIT A CENTER IN PERSON AND IT WAS EXCITING TO INTRODUCE HER TO THE OTHER LEADERS AND HEAR ABOUT THEIR WORK ON ENGAGEMENT AND IT'S A REMINDER OF THE PASSION AND COMMITMENT OF THE PRESIDENT AND FIRST LADY TO CANCER RESEARCH EFFORTS. DURING HER VISIT TO THE NCI WE SHOWED PERSPECTIVES FROM THREE LEADERS AND TALKED ABOUT NCOR AND BRINGS TRIALS TO COMMUNITIES AND WE SPOKE ABOUT WHAT IT'S LIKE TO BRING CUTTING EDGE TREATMENT AND ABOUT THE NCI'S ROLE IN ZOOLOGY EFFORTS AND THE FIRST LADY WAS VERY IMPRESSED BY OUR WORK AND SAID LOVELY POSITIVE REMARKS ABOUT IT. CANCER'S ONE OF THE FIRST LADY'S FOCUS AND DURING THE INITIAL STAGE OF THE NEW ADMINISTRATION WE'VE HAD A VISIT OR TWO FROM THE FIRST LADY AND PRESIDENT TO THE NIH. IT SPEAKS CLEARLY BEABOUT THE NEW ADMINISTRATION'S INTEREST IN SCIENCE AND BELIEF IN THE WORK OF THE NATIONAL CANCER INSTITUTE AND THERE WAS A VISIT TO THE PFIZER PLANNED AND IN THE OVAL OFFICE EVENT ABOUT HIS DESIRE TO QUOTE END CANCER AS WE KNOW IT. CLEARLY WE ARE ALL SUPPORTING THE PRESIDENT IN THAT GOAL. BACK IN DECEMBER I'VE BEEN SPEAKING ABOUT THE COMMEMORATION AND WE'RE TRYING TO GET TOTAL INVOLVEMENT AND AS I MENTIONED LAST YEAR IT'S AN OPPORTUNITY TO INCITE RESEARCH AND THE POTENTIAL FOR THE ACTIVITY TO SPOT LIGHT WHAT WE'VE ACCOMPLISHED IN THE LAST FIVE DECADES FROM BASIC SCIENCE AND AND THE WORK BEFORE US TO MAKE PROGRESS FOR CANCER CARE AND CANCER DISCOVERY. WE STARTED PREPARING SOME MATERIALS AND WANTED TO JOIN WITH THE COMMUNITY IN COMMUNICATING AROUND THE EFFORT AND YOU CAN SEE SOME OF THE IMAGES AND LOGOS WE'VE COME UP WITH AND WE NOW HAVE THE VIDEO WE'D LIKE TO BRIEFLY SHOW. AND CUE UP THE VIDEO AND GIVES A SENSE FOR WHAT WE'RE TRYING TO COMMUNICATE HERE. >> 50 YEAR IN SOME WAYS IT FEELS LIKE A LIFE TIME AGO. IN OTHERS LIKE A BLINK OF AN EYE. TIME TAKES ON NEW MEANING FOR THOSE WHO HEAR THREE WORDS, YOU HAVE CANCER. IT USED TO MEANTIME IS RUNNING OUT BUT THE SIGNING OF THE NATIONAL CANCER ACT OF 1971 PROMISED TO CHANGE THAT. FROM THIS LANDMARK LEGISLATION, A NATIONALLY COORDINATED APPROACH TO RESEARCH WAS BORN. ONE THAT WASTED NO TIME IN ADVANCING CLINICAL TRIAL LED TO REVOLUTIONARY TREATMENTS, IMMUNOTHERAPIES, TARGETED THERAPIES AND ADVANCED TUMOR IMAGING. BUT IT WAS ABOUT MORE THAN TREATMENT, BY PUTTING THE UNPRECEDENTED FOCUS ON BASIC RESEARCH IT HELPED PEOPLE TO TRULY BEGIN TO UNDERSTAND CANCER AND HU TO POSSIBLY PREVENT IT. THE NATIONAL CANCER ACT IS MEN AND WOMEN TAKING PART OF THE GLOBAL EFFORT TO GIVE PATIENTS AND SURVIVORS AND FAMILIES THE GREATEST GIFT OF ALL, MORE TIME. NOTHING WILL STOP US. >> THANK YOU. THAT'S AN EXAMPLE OF THE WAY THE NCI IS DESCRIBING THE EFFORT AND AND THE OPPORTUNITY TO COMMUNICATE CORRECTLY WITH ADVOCACY AND PATIENTS AND CAREGIVERS TO REALLY HELP PEOPLE UNDERSTAND WHAT'S GOING ON IN CANCER RESEARCH AND WHERE THE OPPORTUNITIES ARE. LET ME TALK ABOUT BRIEFLY ABOUT THE CANCER MOON SHOT. WE'RE ROUGHLY AT THE MIDWAY POINT. A LITTLE PAST IT'S SEVEN YEARS OF FUNDING AND JUST STARTING THE FIFTH YEAR. I WOULD ARGUE THE PROGRESS TO DATE HAS BEEN VERY IMPRESSIVE. YOU RECALL CONGRESSIONAL KATED -- ALLOCATED SEVEN YEARS OF FUNDING AND THERE WAS A BLUE RIBBON PANEL AROUND THE AREAS OF FOCUS AND WENT ACROSS A CONTINUUM OF CANCER RESEARCH TOPICS INCLUDING THINGS LIKE IDENTIFYING WAYS TO TARGET DRIVERS OF CHILDHOOD CANCER AND IDENTIFYING RESEARCH TO INCREASE GENETIC COUNSELING AND SCREENING INDIVIDUALS AND EFFORTS TO ENGAGE PATIENTS MORE DIRECTLY IN RESEARCH AND MANY MORE TOPICS YOU CAN SEE 240 INITIATIVES OR PROJECTS THAT HAVE BEGUN UNDER THE MOONSHOT. OF COURSE SOME MAY TAKE YEARS TO TRANSLATE TO CLINICAL BENEFIT BUT WE BELIEVE THE EFFORT IS OFF TO A FANTASTIC START AND IMPRESSIVE. MANY PROJECTS ARE BEGINNING TO ORGANIZE AND SHARE THROUGH WEBSITES AND BLOG POSTS AND WE HAVE AN UPCOMING TOPIC ON CANCER CELL AND WE'RE WORKING FOR FUTURE MOONSHOT AND IT SUN SETS IN TO -- 2023 AND WE NEED TO ENSURE CONTINUATION OF THE PROGRAM WITHOUT THE DISRUPTION OF THE IMPORTANT WORK AS WE TRANSITION THE EFFORTS TO THE OTHER PARTS OF THE NCI BUDGET. MANY INITIATIVES ARE THE FIRST COORDINATED OF THEIR KIND AND WOULD BE DISRUPTIVE TO INTERRUPT THEM NOW MAKING SURE WE'RE GOOD STEWARDS OF THE EFFORTS IS TOP OF THE MIND OF NCI NOW. I LIKE THIS VISUAL DISPLAY SHOWS THE KEY FOCUS AREAS AS SHOWN BY TO THE BLUE RIBBON PANEL AND YOU SEE THE INITIATIVES FUNDED WITHIN EACH OF THE TOPICS AND SEE IN ALL AREAS HAVE HAD RESEARCH SUPPORT IN ALL PHYSICAL YEARS. IT'S AN OVERWHELMING AMOUNT OF NEW RESEARCH THE MOONSHOT SUPPORTED AND THEY'RE OFF TO WONDERFUL STARTS AND THEY'RE TRANSLATING TO PATIENT BENEFIT. WE'LL BE SHARING MORE ANALYSIS OF MOONSHOT PRODUCTIVITY IN A FUTURE DATE. ONE SNAPSHOT WE ALREADY STARTED TO LOOK AT WHICH IS ANALYSIS BY OUR CENTRE FOR RESEARCH STRATEGY AND THERE WAS A CONCERN WHEN THE MOONSHOT BEGAN IT WOULD ONLY FUND THE NCI INSIDERS AND IT WOULDN'T REALLY BRING NEW PEOPLE TO THE FIELD AND THAT'S NOT TRUE. THE MOONSHOT IS BRINGING NEW PEOPLE TO OUR FIELD AND NEW IDEAS AND NEW WAYS OF THINKING IN CANCER RESEARCH AND THIS WAS A KEY GOAL OF THE RESEARCH TO EXPAND THE DIVERSITY AROUND THE RESEARCH AND THIS DATA PROVE WE'VE BEEN SUCCESSFUL IN THAT REGARD. LET ME TAKE A MOMENT FOR THE BUDGET AND WHEN WE LAST MET NCI WAS UNDER A CONTINUING RESOLUTION FOR FY21 AND NOW WE HAVE THE APPROPRIATION FOR THE ENTIRE NIH. IT'S $42.9 BILLION AN INCREASE OF $1.25 BILLION FROM THE PRIOR YEAR AND FOR NCI WE HAVE AN INCREASE FROM 2020 AND $195 MILLION FOR THE CANCER MOONSHOT AND INCLUDED $50 BILLION FO$50 BILLION FOR THE SECOND YEAR YEAR OF THE CHILDHOOD CANCER INITIATIVE AND THE BILL DESIGNATES IN 2021 THE NCI SHOULD SPENT $37.5 BILLION FOR THE COMPETING GRANTS AND SUSTAINING COMMITMENT WITH THE GOAL OF SUPPORTING MORE AWARDS AND IMPROVING SUCCESS RATES. THAT'S A DEDICATION -- A GOAL OF CONGRESS TO INCREASE IT WITHIN THE RBG. IT'S CLEAR CONGRESS HAS HEARD ABOUT THE PAYLINE PROBLEM AT NCI WE HAD IN THE PAST BECAUSE OF SO MANY GREAT APPLICATIONS BEING SUBMITTED AND THIS IS THE SECOND YEAR IN A ROW IN WHICH CONGRESS HAS SPOKEN TO THAT PROBLEM DIRECTLY IN REPORT LANGUAGE BY ASKING NCI TO DEDICATE RESOURCES AND HERE IS THE $306 MILLION OF SUPPLEMENTAL FUNDING TO THE NCI FOR COVID RESEARCH FOR ZOOLOGY AND RELATED TECHNOLOGY. THIS IS FUNDING ALL THE COVID RESEARCH I'VE TALKED ABOUT IN THE PAST YEAR TO BE CLEAR WE DONE THESE EFFORTS WITH THIS APPROPRIATION IN CONGRESS WHILE ALSO CONTINUING OUR DAY JOB OF WORKING AGAINST CANCER USING OUR REGULAR APPROPRIATION FOR THAT. CANCER MONIES HAVE NOT BEEN USED FOR COVID RESEARCH IN OTHER WORDS. THIS ACTION BY CONGRESS IS GREAT NEWS FOR THE RESEARCH COMMUNITY AND THERE'S A BUDGET THAT ALLOWS US TO RAISE PAY LINE FOR OUR HIGHLY COMPETITIVE RO1 GRANTS AND I SPOKE ABOUT THE IMPORTANCE FOR FY22 IN THE BYPASS BUDGET TO THE PAY LINES AND WHERE WE ANNOUNCED THE BOWL -- GOAL OF THE PAY LINE OF IS A BY 25 INITIATIVE I'VE BEEN CALLING IT SOMETHING THE NCI WILL HAVE TO DO GRADUALLY BECAUSE OF THE ADDED COSTS AND THE AND WE HAVE ADDITIONAL FUNDING FOR NON-COMPETING GRANTS ALL CONGRESS'S SUPPORT HAS ALLOWED NCI TO RAISE RO1 AWARDS AND THAT'S A SIGNIFICANT INCREASE IN RECEIVE THIS KIND OF AWARD. FOR TWO CONSECUTIVE YEARS IT'S NOW AT 16 PERCENTILE. IT'S THE BEST PAY LINE FOR AN RO1 IN A LONG TIME. WE'RE PLEASED WE WERE ABLE TO IMPROVE SUCCESS RATES FOR EARLY STAGE INVESTIGATORS SO CANCER WILL BE A CAREER WELCOMING AND WILL LOOK LIKE A PLACE WHERE A NEW INVESTIGATOR HAS A CHANCE OF SUSTAINING AN AWARD OR OBTAINING AN AWARD. WE'RE ALSO SUSTAINING CONTINUING AWARD ON 100% PERCENTILE AND THAT'S THE CLARITY FOR 2021. THE PANDEMIC HAS PROVIDED ADDITIONAL UNCERTAINTIES BEYOND THE USUAL AMOUNT REGARDING OUR BUDGET. THERE'S A NUMBER OF PANDEMIC SOCIETIED COSTS AND WE CAN TALK ABOUT MORE ABOUT THAT IF THERE'S INTEREST -- ASSOCIATED COSTS. WE TALKED ABOUT THE PAST WITH COVID ACTIVITIES IN THE NCI. I'M PROUD OF THE RESEARCH PORTFOLIO. I THINK THE NCI STEPPED UP TO ADDRESS THE EMERGENCY AND I THINK THE WORK OF THE NATIONAL CANCER INSTITUTE HAS BEEN OUTSTANDING WHILE MAINTAINING OUR FOCUS ON THE CENTRAL MISSION OF HELPING PEOPLE WITH CANCER AND HELPING IN THAT RESEARCH AS WELL. THE INSTITUTE SUPPORTS THE COMMUNITY EFFORT TO RECOVER AND CONTINUE PROGRESS IN CANCER RESEARCH AND THAT WILL CONTINUE IN THE NEW YEAR. THE SLIDE SHOWS A BROAD OVERVIEW OF THE ACTIVITIES WE'VE TAKEN ON IN RESPONSE TO THE PRESIDENT-ELECT. AND I WON'T GO THROUGH ALL OF THESE BUT THERE'S A LARGE SEROLOGY NET TO THE LEFT AND A BUNCH OF CLINICAL FUNDS AND FUNDING ACADEMIC INSTITUTIONS STOOD UP QUICKLY AND RESEARCH EFFORTS IN THE MIDDLE INCLUDING THE SURVEYS AND CREATING A REFERENCE STANDARD FOR NATIONAL USE AND PRESUMABLY INTERNATIONAL USE AND SPECIFIC AGENT AND THEN THERE'S WORK WE'VE DONE TO SUPPORT THE RESEARCH COMMUNITY AND OTHER EFFORTS IN THE BOTTOM RIGHT I WON'T GO INTO TODAY UNLESS THERE'S QUESTIONS. I THOUGHT I'D UPDATE YOU ON TWO EFFORTS RELATED TO COVID RESEARCH FROM NCI. FIRST IS THE NCAPS TRIAL AND THE IDEA OF LOOKING AT THE OUTCOME OF PATIENTS WITH CANCER WHO WERE UNFORTUNATE ENOUGH TO GET CORONAVIRUS AND LOOK AT THE NATURAL HISTORY OF ILLNESS AND HAVE ACTIVATED THIS AND CLOSING IN ON 95 SITES IN THE UNITED STATES AND PUERTO RICO AND THIS STUDY WILL BE VERY USEFUL FOR STUDYING COVID-19 WITH CANCER AND IMPORTANT FOR THE SEQUELAE OF COVID INFECTION. I THINK IT WILL BE A VERY IMPORTANT STUDY FOR THAT BECAUSE IT'S A WELL CONSTRUCTED LONGITUDINAL ANALYSIS. ALSO, AS MANY ARE AWARE, THE NCI HAS A LONG HISTORY IN DOING WORK IN THE TOPIC OF VACCINE HESITANCY BECAUSE OF THE LONG WORK FOR VACCINES PREVENTING CANCER CAUSING VIRUSES AND SO VACCINE HESITANCY IS AN ISSUE FOR COVID AND WE'VE BEGUN TO TAKE ON THIS TOPIC AS WELL. THERE'S A TIMELY REPORT ON VACCINE CONFIDENCE AND HESITANCY WRITTEN AND WORKING WITH THE OFFICE OF SOCIAL SCIENCES AND RESEARCH AND FOR THE LAST DECADE THE ISSUE HAS BEEN FOCUSSED ON SOCIAL MEDIA AND SETTING A RESEARCH AGENDA TO BETTER UNDERSTAND AND ADDRESS HEALTH MISINFORMATION ONLINE AND RELATED TOPICS TO PROVIDE ADVICE ON HOW TO CREATE A SHARING ENVIRONMENT FOR USEFUL DATA AROUND VACCINATION THAT WILL NOT LEAD TO MISINFORMATION BUT DECREASE VACCINE HESITANCY. THE REPORT HAS BEEN WIDELY SHARED IN HHS AND NSF, CONSORTIUM OF SOCIAL SCIENCES, AMERICAN PSYCHOLOGICAL ASSOCIATION AND MANY STATE AND PUBLIC HEALTH ENTITIES ARE USING THIS AS DEFINITIVE WORK ON VACCINE HESITANCY AND MAKE A CASE FOR EVIDENCE-INFORMED VACCINATION AND IT'S A USEFUL TOOL TO COMBAT VACCINE MISINFORMATION. THERE'S AN UPCOMING COMMENTARY THAT LEVERAGES RISK COMMUNICATION SCIENCE ACROSS U.S. FEDERAL AGENCIES INCLUDING CDC, FDA AND ALSO OTHER PARTS OF THE GOVERNMENT AND HIGHLIGHTS THE SYNERGY ACROSS EFFICIENCIES AND IS SCIENTIFICALLY DISTANT BUT SHARE A COMMUNICATION OF RISK AND I TURNED THE CHILDHOOD INITIATIVE. IN THE YEAR HEAD WE'LL SPAN ADVOCACY TO RESEARCH NETWORKS AND CARE PROVIDERS. IT'S LED TO A STRUCTURE WITH FOUR WORKING GROUP. THE CANCER DATA INITIATIVE AND CANCER DATA PLATFORM WORKING GROUP DEVELOPING AN INFRASTRUCTURE FOR ENHANCING, SHARING OF NEW AND EXISTING DATA FOR THE NCI AND OTHER SOURCES. THERE'S THE CHILDHOOD COHORT WORKING GROUP GATHERING DATA FROM EVERY CHILD WHO DEVELOPED CANCER AND THERE'S A COORDINATION CENTER WORKING GROUP DEVELOPING AND GUIDELINE TO ADDRESS ACROCROSS-CUTTING ISSUES AND THERE'S A STEERING COMMITTEE TO OVERSEE THE FOUR WORKING GROUPS AND INFORMED BY THE ENGAGEMENT COMMITTEE SHOWN HERE. THE EFFORT CAN BE ONLY SUCCESSFUL WITH THE SUPPORT OF THE COMMUNITY THAT ENGAGES AND SO BELIEVED BY THIS LEADERSHIP AND THE IMPORTANT WORK OF THIS COMMITTEE. AND THE FIRST MEETING OF THE STEERING COMMITTEE WILL BE THIS MONTH SO I THINK THE CCDI IS OFF TO A GREAT START IN A LITTLE MORE OF A YEAR IN ITS EXISTENCE. I SUSPECT MOST ARE AWARE OF THE FULL-COURT PRESS THE RESEARCH COMMUNITY IS PUTTING ON STRUCTURAL RACISM IN BIOMEDICAL RESEARCH. FRANCIS COLLINS ISSUED A STRONG STATEMENT TO THAT LAST WEEK AND IT HAS TO BE ADDRESSED. LET ME START WITH A REVIEW OF THE NIH PROGRAMS RECENTLY DEVELOPED THE UNITE INITIATIVE AND TALK ABOUT WHAT NCI IS DOING ALONG THE LINES. IT'S DESIGNED TO ADDRESS THE NEED FOR DIVERSITY, EQUITY AND INCLUSION IN THE RESEARCH COMMUNITY TO IDENTIFY AND DISMANTLE PRACTICES THAT MAY HARM HE WORKFORCE AND TO END STRUCTUR STRUCTURAL RACISM AND INEQUALITY IN BIOMEDICAL RESEARCH AND THERE'S FIVE WORKING GROUPS WITH THE GOALS SHOWN WITH THE LETTER IN THE WORD UNITE AND AS SOME HEARD THE PRESENTATION OF ACD WORKING GROUP ALSO HEARD DR. COLLINS TALK ABOUT HIS REALLY SPECIFIC PROPOSALS TO START DOING SUBSTANTIVE THINGS TO HELP THE NIH ADDRESS THE PROBLEM. THE NCI HAS BEEN WORKING WITH THE NIH INITIATIVE AND WE SPOKE ABOUT WHAT WE'VE DONE AND IT'S THE EQUITY AND INCLUSION PROGRAM WITH A STRUCTURE SHOWN HERE. WE HAVE AN EQUITY COUNCIL I SHARE WITH PAULA GRAY THAT IS SORT OF A STRATEGIC PLANNING GROUP AND STEERING COMMITTEE AND HAS FIVE WORKING GROUPS FOCUSSED ON DISPARITIES AND RESEARCH WORKFORCE ISSUES AND CREATE CULTURE OF INCLUSION WITHIN NCI AND HAS TWO WORKING GROUPS CHA ARE CROSS CUTTING. ONE IS ON TRACK AND VACCINATION AND THE OTHER DOES COMMUNICATION AND OUTREACH. I YOU CAN SEE THE CHAIRS SHOWN HERE. EACH WORKING GROUP HAS DEVELOPED A ROSTER AND WORKING ON PROPOSALS BOTH AND SHORT-TERM ACTIVITY TO TAKE ACTION IN THE RESPECTIVE AREAS AND IT'S OFF TO A STRONG START AND I WANT TO THANK PAULA GRAY FOR HER LEADERSHIP BECAUSE WE HAVE A LOT OF WORK TO DO. WE DISCUSSED THIS PROGRAM BEFORE THE CANCER GRANT CHALLENGES WE AWARD GRAND TO TEAMS PURSUING THE GRAND CHALLENGES. LETTERS OF INTEREST ARE DUE IN APRI APRIL. THE CHALLENGES SHOWN ON THE SLIDE AND IT REQUIRES INTERNATIONAL TEAMS TO JOIN FORCES TO TAKE ON THE CHALLENGES. WE ANTICIPATE AWARDING US A MODEST NUMBER OF LARGE GRANTS TO ADDRESS THE CHALLENGES TO THE BEST AND MOST PROFISHT -- PROFI PROFICIENT TEAMS AND WE DECIDED TO PUT ON A PAUSE ON THE PREROGATIVE QUESTIONS SO WE WON'T ISSUE A NEW PROGRAM ANNOUNCEMENT IN THE NEAR FUTURE. WE'RE CONDUCTING AN INTERNAL EVALUATION OF THE PROGRAM AND DETERMINE NEXT STEPS AND FELT LIKE A GOOD TIME TO DO THAT GIVEN START THE NEW PROGRAM AS WELL AS OTHER DISRUPTIONS COVERED BY COVID-19. LET ME TALK ABOUT A FEW BITS OF SCIENCE AND THIS IS AN IMPORTANT STUDY IN THE JOURNAL OF SIGNING AND HAS AUTHORIZE FROM FREDERICK NATIONAL LAN AND -- LAB AND INTERNATIONAL LABS AND THE STUDY TOOK PATIENTS WITH ADVANCED MELANOMA WHO INITIALLY DID NOT RESPONSE TO IMMUNE CHECK MOINT INHIBITOR AND -- POINT INHIBITOR AND RECEIVED A FECAL TRANSPLANT AND RECHALLENGED WITH THE DRUG AND A MODERATE NUMBER WHEN RECHALLENGED WITH THE CHECKPOINT INHIBITOR HAD A STABLE DISEASE OR EVEN A RESPONSE SUGGESTING THE FECAL MICROBIOME MAY INFLUENCE THE RESPONSE TO IMMUNOONCOLOGY APPROACHES. VERY INTERESTING FINDING AND THERE'S A TRIAL TO CORROBORATE THE STUDY AND IT SUGGEST THE FECAL MICROBIOME IS RELATED TO THE RESPONSE AND THIS IS THE FIRST TYPE OF THE TRIAL I'M AWARE OF AND SOMETHING TO BE WORKING ON IN THE FUTURE. WE'RE EXCITED ABOUT THIS ANNOUNCEMENT FROM THE U.S. PREVENTIVE SERVICES TASK FORCE WHICH RELEASED THE EXPANDED RECOMMENDATION. AND THIS HAS BEEN AN DRAFT FORM FOR A WHILE AND NOW FINALLY AN OFFICIAL RECOMMENDATION AND REMEMBER THE EVIDENCE FOR THIS IN PART INITIALLY CAME FROM THE WHOLE PRACTICE OF LUNG CANCER SCREENING AND LOW CT SCREENING FROM THE STUDY AN NCI STUDY AND THIS LOOKED AT THE IMPLICATIONS OF STARTING SCREENING AT A YOUNGER AGE AND BELIEVE THE RECOMMENDATIONS WILL DOUBLE THOSE ELIGIBLE FOR LUNG CANCER SCREENING PARTICULARLY WOMEN AND PATIENTS MUCH UNDER REPRESENTED MINORITIES THROUGH THE NEW SET OF RECOMMENDATION. IT'S IMPORTANT TO GET THE BROADER ADOPTION OF SCREENING FOR LUNG CANCER AND HAS A GREAT CHANCE TO REDUCE THE LUNG CANCER INCIDENTS. I'D LIKE TO TALK ABOUT THE EFFORT AT FREDERICK NATIONAL LAB. MANY HAVE HEARD WE HAVE BEGUN AND GENERATED AND CREATED A GNP CAR T MANUFACTURING FACILITY AND HAVE NOW BEGUN TO DEPLOY THE CAPABILITIES FOR MULTI INSTITUTIONAL TRIALS IN ACADEMIC INSTITUTIONS AND PARTNERSHIPS AND THIS IS AN EFFORT TO HAVE A LOT OF GROWTH I THOUGHT IS WHERE THE NCI COULD PROVIDE USEFUL LEADERSHIP AND WE HAVE SEEN THIS WORK AND THERE'S A SHORT VIDEO AND I'LL GIVE A FLAVOR OF IT. >> WHAT SETS IT APART FROM OTHER THERAPY IS THE MAIN MANUFACTURING PROCESS IS THE PRODUCT. >> CAR T CELL THERAPIES ARE CUSTOM MADE FOR EACH PATIENT. MAKING CAR T CELL INVOLVES TAKING WHITE BLOOD CELLS AND CREATING AN ANTIGEN RECEPTOR AND TO FIND AND KILL CANCER CELLS AND THEY GROW BY THE HUNDREDS OF MILLIONS AND INFUSED BACK IN THE PATIENT. IF THAT SOUNDS COMPLEX, THAT IS BECAUSE IT'S. IT'S ALSO EXPENSIVE AND HIGHLY REGULATED BY THE FDA. ONLY A HANDFUL OF RESEARCH LABS IN THE COUNTRY HAVE THE ABILITY TO MAKE CAR T CELL THERAPY TO BE USED IN HUMAN STUDIES. FORTUNATELY, THAT HAS LIMITED CAR T CELL RESEARCH TO SMALL GROUPS OF PATIENTS AT INDIVIDUAL HOSPITALS. TO EXPAND THE RESEARCH WE NEED A CENTRALIZED WAY TO MAKE HIGH QUALITY CAR T CELL AVAILABLE FOR STUDIES FOR MORE PATIENTS AND THAT'S WHAT THE NATIONAL CANCER INSTITUTE HAS STEPPED UP TO DO. NCI HAS ESTABLISHED A CAR T CELL MANUFACTURING PROGRAM AT ITS LABS IN FREDERICK, MARYLAND SPECIFICALLY AIMED AT MAKING THESE TREATMENTS FOR USE IN STUDIES DONE IN MULTIPLE HOSPITALS. USING A SYSTEM CALLED PRODIGY TO TRANSFORM A PATIENT'S WHITE BLOOD CELLS TO A COMPLETE CAR T CELL THERAPY IN SEVEN DAYS. THE FIRST CLINICAL TRIAL TO BE SUPPORTED BY THIS NEW PROGRAM IS BEING LED BY NCI AND CHILDREN'S HOSPITAL OF PHILADELPHIA. THEIR STUDIES TESTING AND EXPERIMENTAL CAR T CELL FOR CHILDREN WITH AN AGGRESSIVE KIND OF LEUKEMIA CALLED ACUTE MYELOID LEUKEMIA OR AML. >> THANK YOU. YOU CAN SEE IT'S INTENDED FOR A GENERAL AUDIENCE INTERESTED IN THE TOPIC AND DESCRIBES WHAT'S GOING WELL IN FED RICK AND MENTIONED ANOTHER CLINICAL TRIAL WITH A DIFFERENT GROUP OF INVESTIGATORS AN EXCITING NEW INITIATIVE FROM NCI AND SOMETHING WE'LL TALK ABOUT MORE AS IT INCREASES CAPACITY AND WE HAVE LOOKED AT A NEED FOR PRODUCTION OF THE VECTOR FOR THE TRIALS AND SOMETHING FREDERICK CAN BE HELPFUL AND ONE LAST ANNOUNCEMENT ON WEDNESDAY AT CTAC NANCY DAVIDSON WILL REPORT OF THE AD HOC WORKING GROUP ON CLINICAL CANCER TRIALS. TUNE IN FOR THAT SESSION AT 1:00 P.M. THAT CONCLUDES MY REPAIRED REMARKS TODAY -- PREPARED REMARKS TODAY. THANK YOU FOR YOUR ATTENTION AND ANY QUESTIONS? >> NED, WITH THE INCREASE IN PAY LINES FOR RO1s IS THERE ANY CHANGE FOR OTHER AWARD MECHANISMS, Ks AND Ps AND Us OR STAYING FLAT? SORRY, I HAVE TO ASK. >> I MAY HAVE TO GET DETE -- DATA AND GET BACK TO YOU. I SHARED RO1s AND ESPI'S IN THE SLIDE. I CAN TELL YOU I THINK PO1s, WE DON'T SET A PAY LINE FOR THOSE BUT WE'LL PROBABLY DO A LITTLE BIT BETTER THAN LAST YEAR IN TERMS OF TRAINING GRANTS AND THEY ASK OLIVER TO COME ON AND PROVIDE MORE DETAILS AND EVERYBODY HUNKERED DOWN DURING THE PANDEMIC AND WROTE APPLICATIONS. IT'S A CHALLENGING GRANT. I EXPECT IT WILL REMAIN SO THIS YEAR. MAYBE I CAN GET YOU MORE INFORMATION AT A LATER SESSION. KEVIN. >> THANKS, NED. TO FOLLOW-UP ON KIM'S COMMENTS I THINK MANY OF US THINK IT'S A LOW NUMBER WITH THE K23 PROGRAM. THERE SEEMS TO BE SUCH AN INBALANCE BETWEEN THE NUMBER OF PHYSICIAN SCIENCES AND THE NEED IN CANCER CENTERS EVERYWHERE FOR THESE FOLKS TO SERVE AS BRIDGES. I WONDER IF YOU'LL LOOK AT IT AT SOME POINT. >> WE'VE HAD DRAMATIC CHANGES AND THE THINGS INSTITUTED THERE. I AGREE THE K AWARDS ARE AN IMPORTANT POOL. CERTAINLY SUPPORTING THAT GROUP OF RESEARCHERS IS A PRIORITY FOR THE NCI. >> IS THERE A THOUGHT HOW IT AFFECT THE INVESTIGATORS AND WHAT IS TO BE DONE ABOUT IT BECAUSE IT'S THE GROUP THAT HAS BEEN REALLY AFFECTED MOST SIGNIFICANTLY. IT IMPACT THE RESEARCH. >> THE IMPACT OF TRAINEES AND EARLY STAGE INVESTIGATORS IS AN IMPORTANT QUESTION. WE'RE STILL GATHERING DATA AS IS THE NIH. MIKE LAUER HAD A BLOG ON THE EFFECT ON THE GROUPS AND GRANTEES. >> IF YOU LOOK AT THE COSTS AND SOME NEEDED A COST EXTENSION TO AN AWARD AND WE'VE THOUGHT ABOUT WHAT TO DO FOR THOSE INDIVIDUALS AND THINK THE QUESTION RAISED ABOUT THE ESI POOL IS IMPORTANT AND WHAT FUNDS THE EARLY CAREER GRANTS THROUGH ASSISTANT PROFESSORS FOUNDATION AWARDS ARE NOT DOING SO WELL THIS YEAR AND THEY'VE NOT HAD FUND RAISING AND THEY'LL HAVE TROUBLE AND THEY'LL NEED AN NCI GRANT MORE THAN OF. LATE STAGE TRAINING GRANTS AND ESI AWARDS ARE AREAS WHERE AND WHERE WE GET ADDITIONAL SUPPORT FOR CONGRESS AND THAT'S WHAT WE'RE ASKING FOR AND IT WOULD BE HELPFUL. I THINK WITH A FEWER MOTHER'S DAY WE'LL BE ABLE TO PROVIDE A FULLER PICTURE WHAT'S GOING ON >> ARE THERE THINGS WHERE THE NCI IS DOING GRANT REVIEW OR MEETINGS OR THINGS THAT HAVE HAPPENED AND WHAT MAY BE WORTH RETAINI RETAINING LONG TERM AND WHAT THAT LOOKS LIKE? >> AFTER DISCUSSIONS FROM THE FDA WE OFFER FLEXIBILITY TO THE CLINICAL TRIALS AND THE ABILITY TO DO CONSENT BY PHONE AND SHIP DRUGS BY MAIL AND THOSE WERE POPULAR AND PROBABLY HELPED PRESERVE TRIALS DURING THE PANDEMIC AND THE INVESTIGATORS LIKED THE TRIALS AND WE HAVE SEEN SUPPORT FOR CONTINUING THAT KIND OF SUPPORT POST PANDEMIC AND WE'VE BEGUN TO THINK ABOUT THOSE KINDS OF THINGS. N NCI'S BEEN ABLE TO REVIEW GRANTS AND THAT'S WORKED DURING THE PANDEMIC WORKING WELL WITH OTHER PARTS OF THE PANDEMIC AND BRINGS UP THE QUESTION OF SOME ADVANTAGES TO VIRTUAL SITE VISITS BY TELECONFERENCE BECAUSE IT'S KEEPER AND YOU GET MORE INVESTIGATORS FROM THE WEST COAST AND PEOPLE ARE MORE LIKELY TO SAY YES. SOME LEVEL OF VIRTUAL REVIEW EXISTS POST PANDEMIC AND THERE'S ROLES FOR IN-PERSON REVIEWS. AND THAT'S IMPORTANT IN THE CANCER CENTER PROGRAM AND WE'RE EAGER TO RESUME SITE VISITS FOR THE PROGRAM AS SOON AS POSSIBLE. WE THINK SOME LEVEL OF VIRTUAL REVIEWS WILL CONTINUE AFTER THE PANDEMIC. WE ALSO FRANKLY HAVE A LOT OF OFFICE SPACE PEOPLE USED TO SIT IN AND WE FOUND A LOT OF OUR WORKERS LIKED TELEWORK AND HAVE BEEN VERY EFFECTIVE AND WE MEASURED LEVELS OF PRODUCTIVITY AND SHOULD ASK OURSELVES WHAT LEVEL OF TELEWORK WE'LL HAVE GOING FORWARD AND YOU'LL ALL PROBABLY EXAMINING THE SAME QUESTIONS AT YOUR INSTITUTIONS RIGHT NOW AND THERE'S A NO STRAIGHTFORWARD ANSWER BUT SOMETHING WE'RE THINKING A LOT ABOUT. >> I WAS GOING TO VOICE ENTHUSIASM FOR MOVING BACK TO THE IN-PERSON ASSET MANY OF THE CANCER PROGRAMS. -- ASSESSMENT OF THE CANCER PROGRAMS. >> AS THE DIRECTOR I KNEW HOW VALUABLE THEY ARE WERE AND SOME THINGS WORK WELL. >> WE CAN'T CHAT TO EVERYBODY IN THE ROOM SO WONDERING IF WE CAN GET THAT FIXED. >> AND >> THANK YOU FOR AN INFORMATIVE PRESENTATION AND TO NOW TO THE LEGISLATIVE REPORT. I'LL COVER THE NEW ADMINISTRATION SOME FRAMING WITH THE COVID RELIEF PACKAGE JUST SIGNED INTO LAW AND A LITTLE BIT OF A PREVIEW OF WHAT WE ANTICIPATE FOR FY22 APPROPRIATIONS. I WANT TO TAKE A MOMENT TO POINT OUT TO THE BOARD MEMBERS THERE'S A DETAILED UPDATE IN YOUR MEETING MATERIALS. THERE'S A LITTLE MORE DETAIL AND THEN I'LL HAVE TIME TO COVER TODAY AND WE'RE HAPPY TO TALK WITH YOU OR YOUR STAFF IF YOU HAVE ANY QUESTIONS IF YOU WANT TO GET IN TOUCH OUTSIDE THE MEETINGS I'M HAPPY TO DISCUSS WHATEVER AREAS YOU WANT MORE INFORMATION ABOUT. WE'RE 55 DAYS IN THE NEW ADMINISTRATION. THE SENATE CONFIRMED 16 OUT OF 23 OF PRESIDENT BIDEN'S CABINET MEMBERS SO FAR. INTERESTINGLY THERE'S A NEW SEAT AT THE TABLE IN THE CABINET ROOM OR WILL BE. DR. ERIC LANDER NOMINATED TO BE THE DIRECTOR OF OFFICE OF SCIENCE AND TECHNOLOGY POLICY. THAT HAS POSITION HAS ELEVATED TO A CABINET LEVEL POSITION. THAT'S NOT HAPPENED BEFORE. THE POSITION ALWAYS REQUIRED SENATE CONFIRMATION AND IT STARTED IN THAT ROLE IS JANUARY 25th. HE'S ON THE JOB IN SOME CAPACITY ONE NOMINEE WHO WE EXPECT TO BE CONFIRMED ANY DAY NOW IS THE NOM NOMINEE FOR SECRETARY OF HEALTH AND HUMAN SERVICES AND JAVIER BECERRA IS A LONG-TERM MEMBER OF HOUSE AND HAS BEEN THE ATTORNEY GENERAL OF CALIFORNIA THE POSITION KAMALA HARRIS HAD AND HAS BEEN ACTIVE IN TOBACCO CONTROL ISSUES AND THE LAWSUIT AGAINST JUUL AND THE ONLY THING LEFT IS TO BRING IT UP ON THE FLOOR FOR A VOTE SO IT'S' MATTER OF TIME AND WE'RE HOPE UNTIL THE SECRETARY IS IN PLACE IN THE NEAR FUTURE. WHEN WE MET LAST WAS THE LAME DUCK CONGRESS AND THERE WERE TWO JANUARY RACES YET TO KNOW THE RESULTS OF AND THERE WERE STILL SEVERAL RACES IN THE HOUSE NOT CALLED AT THIS POINT WHERE THINGS LANDED AND THERE'S THE LIMBEST OF MAJORITIES. THE DEMOCRATS LOST 13 SEATS AND REMAINED THE MAJORITY. RIGHT NEW IT'S 220 TO 211 WITH FOUR VACANCIES AND SOON TO BE FIVE. TWO ARE FOUR REPUBLICAN MEMBERS BOTH OF WHO DIED FROM COVID AND A 41 DIED BEFORE HE COULD TAKE OFFICE AND A 67-YEAR-OLD THE ONLY SITTING MEMBER OF CONGRESS TO DIE FROM COVID WAS ALSO A LUNG CANCER PATIENT. THE OTHER IS A DEMOCRAT FROM LOUISIANA WHO JOINED THE BIDEN ADMINISTRATION AND ANOTHER FROM OHIO WILL BE SECRETARY OF HUD. THERE'LL PROBABLY BE ONE MORE HOUSE MEMBER LEAVING CONGRESS AND THINKS ARE HAPPENING AND LEAVES SPEAKER PELOSI WITH A SLIM MARGIN AND VICE PRESIDENT HARRIS CAN BE -- IF NEEDED BUT SENATOR SCHUMER HAS TO OLD EVERY SINGLE VOTE AND THAT IS CHALLENGING. ONE THING ABOUT THE CONGRESS THAT IS NOTABLE FOR THE SIXTH CONGRESS IN A ROW THEY BROKE RECORDS ABOUT BEING THE MOST ETHNICALLY DIVERSE CONGRESS AND THERE'S A 50% INCREASE IN WOMEN IN THE PAST 10 YEARS. I WANTED TO SHOW YOU WHO IS ON WHAT COMMITTEES. THE REASON IS THIS MISHOUSE ENERGY AND COMMERCE COMMITTEE AUTHORIZES LEGISLATION AND AGENCIES AND IF THERE WERE A CHANGE TO BE IN THE MISSION OR A 21st CENTURIES CURE PACKAGE THEY WOULD HOLD THE PEN IN THE HOUSE ON THE REPUBLICAN SIDE WE HAVE A NEW RANKING MEMBER FOR THE FULL COMMITTEE AND NEW MEMBER AS A HEALTH SUBCOMMITTEE. WE HAVE THE CENTER FROM WASHINGTON IS NOW THE CHAIR AND THE FORMER CHAIR RETIRED. THE TOP RANKING REPUBLICAN IS NOW RICHARD BURR OF NORTH CAROLINA. WE TALK ABOUT APPROPRIATIONS BECAUSE THEY HAVE TO PASS BILLS TO GET THE GOVERNMENT FUNDED AND IF THEY'RE NOT PASSING APPROPRIATION BILLS THEY'RE PASSING CONTINUED RESOLUTIONS. IN THE HOUSE WE HAD ONE CHANGE CONGRESS WOMAN OF NEW YORK WAS THE CHAIR OF THE FULL APPROPRIATIONS COMMITTEE AND THE OTHER IS REMAINING CARE OF THE LABOR HHS SUBCOMMITTEE. HER REPUBLICAN COUNTERPART IS FROM TEXAS AND ONE FROM OKLAHOMA FROM THE SUBCOMMITTEE. ON THE RANCORS BECAME CHAIRS AND THE CHAIRS BECAME RANKERS. THE GOOD THING AND I WANT TO POINT OUT THESE INDIVIDUALS WORKING TOGETHER FOR THE PAST EIGHT TO NINE YEARS IN A PRODUCTIVE WAY AND IT WASN'T ALWAYS LIKE THAT FOR THE SUB SUBCOMMITTEE. IT'S GREAT WE HAVE PEOPLE STAYING IN PLACE WITH A HISTORY OF SUCCESSFUL COLLABORATION. THIS IS A TIME LINE OF THE MAJOR COVID PACKAGES THERE'S TWO THINGS I WANTED TO POINT OUT. THE FIRST LAST SPRING WHEN WE REALIZED THIS WAS GOING TO BE A BIG DEAL. CONGRESS ACTED EXTREMELY QUICKLY AND IN SEVEN WEEKS THEY PASSED ON A BIPARTISAN BASIS FOUR DIFFERENT PACKAGES TOTALLING ALMOST $3 TRILLION. THE SPEED AND THE SIZE OF THE PACKAGES WERE REALLY SOMETHING. THERE STARTED TO BE MORE DIVERGENT OPINIONS ON WHAT WAS NEEDED OVER THE SUMMER AND THINGS BECAME MORE PARTISAN AND THORNY FOR THE NEGOTIATIONS. IN DECEMBER AFTER CHRISTMAS, CONGRESS PASSED THE FY2021 APPROPRIATIONS BILL FOR THIS FIS YAL YEAR AND COMBINED -- FISCAL YEAR AND COMBINED WITH THE CORONAVIRUS RELIEF PACKAGE ALL IN A BIPARTISAN BASIS AND THE ACTIVE RESCUE PLAN FOR $1.9 TRILLION COVID PACKAGE WAS DONE WITH NO REPUBLICAN VOTES PARTLY BECAUSE OF THE PROCESS USED TO GET THE VOTE DONE. IT WAS DIFFICULT AND DROWN OUT AND KIND OF DRAMATIC. THE RECONCILIATION STARTS WITH A BUDGET RESOLUTION AND INSTRUCTION TO COMMITTEE TO WRITE LEGISLATION THAT AFFECTS SPENDING, REVENUES OR DEFICITS. THERE'S ONLY THINGS THAT CAN BE INCLUDED IN A RECONCILIATION PACKAGE. THE PROVISION TO REQUIRE A $15 FEDERAL MINIMUM WAGE WAS VOTED NON GERMANE TO THE PACK AND AND STRUCK OUT BY THE SENATE PARLIAMENTARIAN AND PREVENTS A PROCEDURAL HURDLE WHICH IS THREAT OF A FILL BESTER IN THE SENATE. -- FILIBUSTER. YOU DON'T NEED TO GET 60 VOTES IN THE SENATE AND THAT MADE ALL THE DIFFERENCE IN GETTING THIS DONE REQUIRING THE SENATE TO DO TWO ALL-NIGHTERS. VICE PRESIDENT HARRIS CAME TO THE FLOOR TWICE TO BREAK TIES. AND VOTERAMA. THE MINORITY IS ALLOWED TO OFFER UNLIMITED AMENDMENTS TO THE LEGISLATION AND THEY CAN FORCE VOTES AS LONG AS THEY VOTE ON AS MANY AMENDMENTS AS THEY WANT AND REFERRED TO AS VOTERAMA. WITH THE MOST RECENT BILL THAT WAS AN ADDED QUIST THE DEMOCRATS WERE -- TWIST. THERE WAS A 12-HOUR DELAY WHERE REPUBLICANS AND DEMOCRATS TRIED TO CONVINCE CENTER JOE MANCHIN OF WEST VIRGINIA TO SIDE WITH THEM AND WAS NOT SATISFIED WITH THE LENGTH OF TIME UNEMPLOYMENT PAYMENTS WOULD BE MADE OR THE AMOUNT TAX DEFERRED. THAT PROCESS DOUBLED THE DEBATE AND FINALLY THAT WAS RESOLVED WITH CHANGE AND NOW THE VOTE COULD GO EITHER WAY FOR DIFFERENT ISSUES. THAT'S SOMETHING MAJORITY LEADER SCHUMER HAS TO PLAN AHEAD IN LEGISLATION. IT ENDED UP BEING A PARTY LINE VOTE AND ONE OF THE REPUBLICANS WAS HUNG WITH A FAMILY EMERGENCY AND THE VOTE WAS FINALLY PASSED AND SIGNED INTO LAW LAST THURSDAY. THERE'S FUNDING FOR HHS AND NOT SPECIFICALLY DIRECTED TO NIH AND THERE'S FUNDING IN TWO TO THREE AREAS. DETAILS ARE STILL EMERGING EVERYWHERE DAY IN POLITICAL REPORTING ABOUT DIFFERENT DETAILS THERE'S FUNDING FOR TELEHEALTH AND PROVISIONS ABOUT PSYCHOSOCIAL REPORT FOR CHILDREN AND INDIAN HEALTH SERVICE USE OF TELEHEALTH AND THAT'S OF INTEREST TO A LOT OF OUR RESEARCHERS AND WE'LL FOL THOSE ISSUES. -- FOLLOW THOSE ISSUES. WE TALKED ABOUT THE RESTART COSTS. I'VE HEARD OF IT AS RESEARCH RELIEF RECENTLY. NO PROVISIONS ABOUT THAT WERE IN THIS PACKAGE UNFORTUNATELY. THERE WAS LEGISLATION INTRODUCED IN THE RISE ACT FUNDING TO SCIENCE AGENCIES TO SUPPORT RESEARCH RESEARCHERS IMPACTED BY THE PANDEMIC AND THAT LEGISLATION INCLUDES A $10 BILLION AUTHORIZATION FOR NIH. IT WAS RE-INTRODUCED IN THE CONGRESS AND THERE'S CURRENTLY ABOUT 124 CO-SPONSORS. CONGRESS HEARD THIS MESSAGE AND HEARD FROM UNIVERSITIES AND ARE PAYING ATTENTION. THERE WERE EFFORTS BY APPROPRIATORS TO INCLUDE LOST PRODUCTIVITY. NOOERJ BECAME LAW IN THE FINE SPENDING BILLS. THERE'S BEEN AN EXTRAORDINARY LIST OF NEEDS AND A RESPONSE AND SOMETHING WE HEAR TALK ABOUT. THERE WAS AN EFFORT DURING THE ENERGY AND MARK UP OF THE PACKAGE TO ADD AN AMENDMENT TO PROVIDE $10 BILLION FOR NIH FOR RESEARCH COSTS. THE AMENDMENT WAS NOT ADOPTED REALLY THE COMMITTEE'S COMMENTS WERE NOT THAT IT WASN'T THEY WOULD HAVE LIKED TO DO. THEY DIDN'T HAVE AN EXTRA $10 BILLION AND WOULD HAVE HAD TO CUT IT FROM SOMETHING ELSE STILL FRAMED AS A RESCUE PASSAGE. IT WAS SEEN AS NOT FITTING IN AT THIS POINT IN TIME. THERE ARE OTHER OPPORTUNITIES COMING AND HOPEFULLY THERE'S ANOTHER LEGISLATIVE VEHICLE WHERE IT COULD BE ADDRESSED WITH THE POSSIBILITY OF APPROPRIATIONS. WE DON'T KNOW WHAT THE TIMING WILL BE FOR APPROPRIATIONS THIS YEAR OTHER THAN LATER THAN USUAL A NEW PRESIDENT AND ADMINISTRATION HAS AMORE TIME TO SUBMIT A BUDGET REQUEST TO CONGRESS. TIP TRIP IT'S THE FIRST MONDAY IN FEBRUARY. AND ANOTHER COMPLICATION IS THERE'S AN EXPIRATION OF THE DEBT LIMIT SUSPENSION ON JULY 31 OF THIS YEAR AND TRIGGER A DISCUSSION ABOUT BUDGET CAPS AND THAT WILL COMPLICATE THE APPROPRIATIONS PROCESS. WHAT WE ANTICIPATE IS A SKINNY BUDGET AN OUTLINE OF TOP PRIORITIES COULD BE ANY DAY, SOME TIME THIS MONTH AND LATER PROBABLY NEXT MONTH OR IN MAY A FULL BUDGET REQUEST COMING TO CONGRESS. AND PRESIDENTIAL ELECTIONS COMPLICATE NOT ONLY THE CURRENT YEAR APPROPRIATION AND IN THE 2021 ELECTION IN NOVEMBER OF 2012 WE'RE IN FIPHYSICA PHYSICAL -- FISCAL YEAR 13 AND THIS CHARTS SHOWS HOW LONG. IN 2016 THERE WAS AN EXTRAORDINARY DELAY. WE DIDN'T GET OUR APPROPRIATION UNTIL MAY AND THEN EVEN LONGER WE DON'T KNOW WHAT THAT'S GOING TO LOOK LIKE. THEY HAVE TO HOLD HEARINGS AND DRAFT BILLS AND GET THEM THROUGH COMMITTEE AND THEN THE CHAMBER. THERE'S AN OPPORTUNITY TO CONSIDER THINGS LIKE RESEARCH COST AND RELIEF FOR UNIVERSITIES. THE OTHER OPTIONS PRESIDENT BIDEN HAS TALKED OR TALKED ON THE CAMPAIGN TRAIL ABOUT AN INFRASTRUCTURE PACK AND AND YOU HEAR SECRETARY TALK ABOUT THIS AND THE PRICE TAGS ARE IT -- $2 TRILLION AND UP AND NO WAY TO KNOW HOW IT WILL SHAKE UP EXCEPT SENATOR MANCHIN WAS IN AN INTERVIEW IN THE PAST WEEK AND SID HE WILL NOT SUPPORT -- SAID HE WILL NOT SUPPORT A RECONCILIATION PACKAGE FOR INFRASTRUCTURE AND WANTS IT TO BE BIPARTISAN PACKAGE AND THAT WILL CHANGE HOW THEY DO THINGS AND THERE'S TALK ABOUT HAVING A PACKAGE DIVIDED INTO AN UP OR DOWN VOTE WHERE YOU MAY NOT BE ABLE TO GET BIPARTISAN SUPPORT BUT BREAKING ITS UP INTO PIECES WITH BROADBAND ACCESS AND THE COVID PANDEMIC HAS HIGHLIGHTED THE DISPARITIES FOR URBAN AND RURAL ACCESS AND AVAILABLE NATIONWIDE AND THEY'RE LOOKING AT A BROADER DEFINITION THAT COULD INCLUDE OPPORTUNITIES FOR RESEARCH. SENATOR SCHUMER IS PUSHING SENATE COMMITTEES TO DRAFT ON TECHNOLOGY AND COMPETING WITH CHINA AND CREATING NEW JOBS AND ACCELERATING AMERICAN PROGRESS AND TECHNOLOGY SAYING IT'S THE CENTERPIECE OF THE LEGISLATION AND A BILL INTRODUCED IN THE LAST CONGRESS CALLED THE LAST FRONTIERS ACT. THAT BILL WOULD HAVE INCREASED THE BUDGET FOR THE NATIONAL SCIENCE FOUNDATION UP TO $100 BILLION AND IT'S STARTING IN A PRESS CONFERENCE HE TALKED ABOUT BIOMARKER RESEARCH AS POTENTIALLY BE PART OF THE PACK AND -- PACKAGE AND THIS HAS BIPARTISAN SUPPORT FOR SOME PRINCIPLES BEHIND THIS KIND OF LEGISLATIVE APPROACH. AS DR. SHARPLESS POINTED OUT QUOTING THE FIRST LAID AND PRESIDENT AND CANCER RESEARCH IS PERSONAL TO THEM AND TELEGRAPHED A STRONG COMMITMENT TO DO SOMETHING AND TO PRESIDE OVER THE END OF CANCER AS WE KNOW IT. THERE WAS A BIPARTISAN MEETING IN THE OVAL OFFICE WITH BOTH CENTERS AND MEMBERS OF THE HOUSE OF REPRESENTS IN EARLY MARCH AND THERE WERE COMMENTS ABOUT THE MEMBERS WHAT PLAY KEY ROLES IN THE 21st CENTURIES CURES ACT AND FUNDS APPROPRIATED FOR THAT EFFORT. WE'LL SEE WHERE IT GOES BUT IT'S SOMETHING THAT'S REACHING TO A BROUGHT POPULATION WITHIN CONGRESS TO SUPPORT AND EXCITED TO SEE WHAT PROPOSALS COME OUT OF THIS. HAPPY TO TAKE QUESTIONS NOW OR IN THE FUTURE. I KNOW WE'RE SHORT ON TIME. >> THANK YOU. MAYBE WE'LL PICK UP UNLESS THERE'S ONE QUESTION THAT SOMEONE WOULD LIKE TO ASK NOW AND MAYBE WE CAN PICK UP ON SOME REMAINING QUESTIONS LATER IF THERE IS TIME. >> SO THE NEXT PRESENTATION IS NCI CENTER FOR BLBL HEALTH CELEBRATING 10 YEARS AND LOOK AHEAD AND THE DR. GOPAL IS TO THE DIRECTOR FOR GLOBAL HEALTH. >> THANK YOU, I DIRECT THE NCI CENTER FOR GLOBAL HEALTH ESTABLISHED 10 YEARS AGO AND GRATEFUL FOR THE OPPORTUNITY TO DISCUSS OUR WORK AND IDEAS ABOUT MOVING FORWARD. THE ANNIVERSARY COINCIDES WITH THE 50th ANNIVERSARY OF THE NATIONAL CANCER ACT. WE HAVE BEEN TRYING TO AMPLIFY THE MESSAGE WITH OUR INTERNATIONAL PARTNERS WHICH HAS BEEN EXTREMELY WELL RECEIVED. MANY COUNTRIES ARE AWARE THE IMPORTANCE OF THIS LANDMARK FOR ACCELERATING PROGRESS AGAINST CANCER AND LOOKING FOR SOMETHING AND IT'S ALLOWING US TO HIGHLIGHT IMPORTANT GLOBAL HEALTH STORIES WITHIN THE NARRATI NARRATIVE AND MY ON WORK LOOKS AT LYMPHOID MALIGNANCIES IN AFRICA AND I LIKE THE GAME BECAUSE IT NICELY ILLUSTRATES THE SUCCESSES AND FAILURES AND INEQUITIES OF THE GLOBAL CANCER RESEARCH STORY. IN A MONTH WHERE DR. COLLINS AND SHARPLESS HAVE MADE COMMENTS ON ADDRESSING STRUCTURAL RACISM AND NEED TO ACKNOWLEDGE HOW THE ISSUES ARE PART OF THE COMPLICATED HISTORY OF GLOBAL CANCER RESEARCH. STARTING IN TOP LEFT IN 1958 THERE WAS A NEW TUMOR DISCOVERED AND IT LED TO A NEW ONCOGENIC ADVANCE AND IT CONTRIBUTED TO THE DISCOVERY OF MULTI AGENT THERAPIES AND A DISCOVERY OF THE 814 TRANS LOCATION IN THE PROTEIN. THIS IS FOL A TYPE OF LYMPHOMA SHOWING TUMOR BIOLOGY IS DETERMINED BY THE PRESENCE OF EBB AND THERAPEUTIC OPTIMIZATION IS PRODUCED AMAZING PATIENT OUTCOMES ACROSS ADOLESCENTS AND ADULTS INVOLVING CLINICAL TRIALS. IN CELEBRATING NCI50 DR. SHARPLESS SPOKE ABOUT THE PACE OF PROGRESS IN CANCER PERHAPS EXCEEDING ANY OTHER DEED IN THE HISTORY OF TIME IN BIOMEDICAL RESEARCH EVEN ACCORDING TO THAT HIGH STANDARD GOING FROM THE DISCOVERY OF A NEW HUMAN TUMOR TO FIRST LINE CURE OVER THIS PERIOD IN THE CONTEXT OF CLINICAL TRIALS IS REMARKABLE. WE SOMEWHERE NOT YESTERDAY DISCOVERED A DELIVERABLE SOLUTION BACK TO THE HUMANS WHO HELPED IN THE SCIENTIFIC PROGRESS. DURING THE DECADE I LIVED AND WORKED IN SUB-SAHARAN AFRICA I ROUTINELY SAW CHILDREN WHO PRESENTED AS THEY DID IN THE 1950s AND 1960s WITH SIMILAR OUTCOMES. AND WE FAILED TO COMPLETE WHAT SEEMS LIKE AN OBVIOUS NEXT STEP USING WHAT WE KNOW ABOUT THE TUMOR BIOLOGY AND THERAPEUTIC VULNERABILITIES CAN WE DEVELOP LESS TOXIC TREATMENTS TO ABBE APPLIED TO PATIENTS WORLDWIDE. I'LL ALSO OFFER A QUICK COUNTER POINT IN CELEBRATING NCA50. I MOVED TO MA MALAWI WITH MY DAUGHTER AND AN OPPORTUNITY TO DIRECTLY BENEFIT FROM RESEARCH CONTRIBUTED DOES REPRESENTATIVE A FAIRLY STARK CONTRAST TO THE UGANDAN CHILDREN FROM MY PREVIOUS SLIDE. WITHOUT TAKING TIME TO READS LANGUAGE FROM THE ORIGINAL LEGISLATION I DO LAKE TO REMIND PEOPLE THE NATIONAL CANCER ACT EXPLICITLY DIRECTED THE NCI TO ENGAGE IN GLOBAL CANCER RESEARCH AND TRAINING THESE GLOBAL ENGAGEMENTS WERE FELT TO REQUIRE A DEDICATED CENTER FOR GLOBAL HEALTH TO INCORPORATE CANCER CONTROL AND WORK WITH COLLABORATORS WITH SHARED OBJECTIVES. THE CREATION WAS IMPORTANT FOR ME PERSONALLY IN 2011 I WAS STARTING THE LAST YEAR OF MY HEMATOLOGY ONCOLOGY FELLOWSHIP AND CONTEMPLATING A PHYSICIAN SCIENTIST CAREER FOCUSSED ON GLOBAL HEALTH. THE CREATION OF CGH AT NCI MADE ME FEEL THE STRANGE CAREER CHOICE WAS WORTHWHILE AND CREATION OF CGH PROBABLY MADE MY INSTITUTION FEEL THIS CAREER CHOICE WAS WORTHWHILE. LARGELY BECAUSE I HAD EARLY CAREER FUNDING AND BECAUSE NCI SNALD A STRONG INTEREST AND MY CANCER CENTER WAS WILLING TO ENGAGE WHAT WAS A SOMEWHAT LUDICROUS CAREER PROPOSITION AND JOINING THE FACULTY AND MOVING TO A CULTURALLY RICH COUNTRY WHERE ANNUAL SPEND PER CAPITA IS $100,000 AND SUPPORT A CLINICAL RESEARCH CAREER AND PROGRAM PRIMARILY BY WRITING GRANTS. I ALLUDED TO THE MORAL AND SCIENTIFIC IMPORTANCE AT THE LEVEL OF INDIVIDUAL PATIENTS IN REFERRING TO THOSE WITH LIYMPHOMA AND THIS IS TRUE AT A POPULATION LEVEL AS WELL GIVEN 69% CANCER DEATHS WILL OCCUR IN LMICs WITH LOW INCOME COUNTRIES EXPERIENCING THE LARGEST PROPORTIONAL INCREASES IN CANCER BURDEN RELATIVE TO CURRENT ESTIMATES OVER THE NEXT 20 YEARS. TO BRIEFLY TOUCH ON COVID THIS IS HAVING WORLD EFFECTS ON CANCER SCREENING AND TREATMENT THOUGH I THINK WE'RE STILL LEARNING WHAT THE LONG-TERM EFFECTS WILL BE PARTICULARLY IN LMICs WHERE THE REAL AND MOIDEL DATA IS NOT AS GOOD AS IN HIGH INCOME COUNTRIES. WE NOW HAVE AN OPEN SUPPLEMENT OPPORTUNITY FOCUSSED ON STUDYING THE IMPACT OF COVID-19 ON GLOBAL CANCER PREVENTION AND CONTROL WHICH SEEMED LIKE A NEED NOT BE ADDRESSED BY FUNDING OPPORTUNITIES AND WOULD LIKE TO CONTINUE THINKING ABOUT THE AREA AND HOW TO CONTINUE TO FOSTER RESILIENCY FOR CANCER CONTROL DURING THE CURRENT AND FUTURE PANDEMICS AS WELL AS OTHER DISRUPTS. SO IN THIS CONTEXT WE'VE BEEN WORKING OVER THE LAST YEAR TO UPDATE OUR CGH STRATEGY FOR LEADING GLOBAL HEALTH EFFORTS AT NCI AND ADDRESSING SOME OF THESE GAPS. OUR MISSION IS TO ADVANCE GLOBAL CANCER RESEARCH AND COORDINATING NCI ENGAGEMENT AND CONTROL. WE ACHIEVE WORLDWIDE SUFFERING THROUGH DISCOVERY AND DISSEMINATION AND INTEND TO ORIENT OUR ACTIVITIES AROUND THE CORE VALUES OF IMPACT, EQUITY AND COLLABORATION. WE HOPE TO SUPPORT INNOVATIVE IMPACTFUL RESEARCH FOR GLOBAL CANCER CONTROL AND LEVERAGE UNIQUE OR UNUSUAL SCIENTIFIC OPPORTUNITIES WITH GLOBAL PARTNERS. SECOND, WE HOPE TO SUPPORT GLOBAL CANCER RESEARCH TRAINING THAT ENABLES IMPACTFUL SCIENTIFIC COLLABORATION AND THIRD WE PROMOTE THE SCIENTIFIC KNOWLEDGE INTO GLOBAL CANCER CONTROL AND POLICIES IN MRAKTS AND FINALLY WE PLAY A ROLE IN REPRESENTING THE NCI AND PROMOTING ENGAGEMENT WITH KEY PARTNERS IN GLOBAL CANCER RESEARCH AND CONTROL. OF NOTE FOR CGH-LED PROGRAMS IT WILL FOCUS ON LMIC SETTINGS WITH MOST THE WORLD'S CANCER BURDEN UNREPRESENTED IN THE NCI PORTFOLIO AND WHERE WE BELIEVE THERE ARE IMPORTANT RESEARCH AND CONTROL OPPORTUNITIES I WANT TO BRIEFLY ELABORATE ON THE GOAL AREAS WE PLAN TO ACCEL DEPLOYABLE TECHNOLOGIES FOR GLOBAL CANCER CONTROL AND ACCELERATING IMPLEMENTATION SCIENCE AND INCREASING SUPPORT FOR CANCER TRIALS AND INCREASING UNDERSTANDING OF CANCER ETIOLOGY THROUGH COLLABORATION WITH GLOBAL INVESTIGATORS AND POPULATIONS. WE HAVE EXISTING AND I WON'T SPEND A LOT OF TIME DISCUSSING EACH PROGRAM BUT SEVERAL HAVE COME BEFORE THE VASVSA AND WE LOOK FORWARD TO BUILD THE PORTFOLIO IN CONSULTATION WITH ALL OF YOU. I WANTED TO PROVIDE EXAMPLES OF THE TYPE OF RESEARCH WE SUPPORT AND ON THE LEFT IS THE AFFORDABLE CANCER TECHNOLOGIES PROGRAM WHICH WAS TO ACCELERATE THE DEVELOPMENT OF BATTERY POWERED PORTABLE COAGULATION DEVICE TO TREAT PRE-CERVICAL CANCER AND WITHOUT CRYOTHERAPY AND ACHIEVING THE STRATEGY WAS VIRTUALLY IMPOSSIBLE AND THEY INCORPORATED THE GUIDELINES RECOMMENDED AND THE REISSUANCE OF THE AFFORDABLE TECHNOLOGIES PROGRAM WAS APPROVED IN THE LAST MEETING IN DECEMBER AND PUBLISHED LAST MONTH. WE'RE GENUINELY EXCITED ABOUT CONTINUING TO SUPPORT SUCH INNOVATIVE GLOBAL HEALTH TECHNOLOGIES IN THE PROGRAM. ON RIGHT ARE DATA FROM A RANDOMIZED CLINICAL TRIAL TO REDUCE HOUSEHOLD EXPOSURE AMONG PREGNANT WOMEN IN FOUR COUNTRIES SHOWING HEALTH RELEVANT REDUCTION IN FINE PARTICULATE MATTER WAS ACHIEVABLE AT INDIAN TRIAL SITES. IT'S FOCUSED ON INFANT GROWTH AND PNEUMONIA AND WE ARE INCORPORATING SUPPORT WITH MULTIPLE INSTITUTES TO ASSESS SEVERAL BIOMARKERS AND THEREBY ASSOCIATE AIR POLLUTION AND CANCER RISK. I WANT TO TURN TO GLOBAL CANCER RESEARCH TRAINING AND WITH COLLABORATIONS BETWEEN NCI CANCER CENTERS AND THEIR INSTITUTIONAL PARTNERS WITHOUT A COMMENSURATE GROWTH IN DEDICATED GLOBAL CANCER RESEARCH TRAINING WE DEVELOPED A NEW D43 PROGRAM TO STRENGTHEN PART PART AND WE HOPE TO MAKE THE FIRST AWARD SOON WITH THE SECOND THIS COMING JUNE WE SUPPORT EARLY CAREER INVESTIGATORS INDUCTING MENTORED CANCER RESEARCHES IN LMICs AND SUPPORT EXPERIENTIAL OPPORTUNITIES TO WORK WITH EXTRAMURAL AND INTRAMURAL COLLABORATORS. ON RIGHT SAY RECENT OUTCOME FROM THE INTRAMURAL ENGAGEMENTS BETWEEN INVESTIGATORS AND CCR AND INDIA FOCUSSED ON DEVELOPING CELLULAR THERAPY CAPACITY IN INDIA. WE ALSO SUPPORT CANCER CONTROL. ONE IS THE INTERNATIONAL CANCER CONTROL PARTNERSHIP WITH A GROUP OF TECHNICAL EXPERTS TO PROVIDE GUIDANCE TO COUNTRIES IMPLEMENTING CANCER CONTROL PLANS. THAT GRUP HAS BEEN PARTICULARLY FOCUSSED ON ENCOURAGING A CONTINUED COMMITMENT TO GLOBAL CANCER CONTROL EVEN DURING COVID AND WE HELPED COORDINATE PARTICIPATION IN THE INTERNATIONAL CANCER SCREENING NETWORK AND COORDINATE THE COLLABORATING CENTER AGREEMENT FOR CANCER CONTROL. LAST WEEK WE HELD THE SYMPOSIUM ON GLOBAL EARTH RESEARCH WITH SEVERAL CANCER CENTERS AND INSTITUTIONAL PARTNERS AS A VIRTUAL MEETING. THIS HAS BECOME ONE OF THE LONGEST RUNNING SCIENTIFIC MEETINGS RESEARCHED ON CONTROL AND LAST WEEK'S MEETING WAS A TREMENDOUS SUCCESS WITH PARTICIPANTS FROM ALL AROUND THE WORLD. TIMELY I WANT TO TOUCH ON OUR PARTNERSHIP OPPORTUNITIES AND I WE'VE DOCUMENTED AND SUPPORT THE GROWTH OF ONCOLOGY AND SHARE THEM WITH THE BROADER COMMUNITY. WE ALONG WITH THE CENTER FOR RESEARCH STRATEGY HELPED INITIATE THE INTERNATIONAL RESEARCH PARTNERSHIP TO CONSOLIDATE DATA FROM FUNDERS AROUND THE WORLD WE PROVIDED EXTERNAL ADVICE FROM IARC IN THEIR STRATEGIC PLAN AND WE SUPPORT INTERNATIONAL AGREEMENTS AND COLLABORATIONS ACROSS NCI. I REFERENCED THE ALL IRELAND CONSORTIUM AGREEMENT WITH NCI AND COLLEAGUES IN IRELAND AND NORTHERN IRELAND THIS RESULTED IN A MARKED RESEARCH PRODUCTIVE ON THE CANCER OF IRELAND AND RENEWED TOMORROW ON ST. PATRICK'S DAY WHERE WE'VE BEEN PROVIDED KEY COMMUNICATION AND ADMINISTRATIVE SUPPORT. WE BELIEVE IT PRESENTS IMPORTANT OPPORTUNITIES FOR A RENEWED AND AMBITIOUS STRATEGY FOR GLOBAL HEALTH AT NCI AND I TRIED TO HIGHLIGHT SOME OF THE BROADER THEMES AROUND THIS AND BELIEVE THEY'RE NOT ANCILLARY BUT RATHER CENTRAL TO THE MISSION AND THE EQUITY GOALS. WE ADD CGH HOPE TO LEAD IT LEADING FORWARD TO REALIZE THE OPPORTUNITIES AND ADDRESS CRITICAL GAPS AND BACK TO A SLIDE I SHOWED AT THE BEGINNING AND HIGHLIGHTED THE FACT THAT WE HOPE TO SUPPORT AND APPLY RESEARCH AGENDA CONCEPTUALLY CENTERED AROUND THE INCOMPLETE ARROW I REFERRED TO EARLIER. IT'S CLEAR THIS WILL REQUIRE LEVERAGING NCI AND THE BSA AND WE LOOK FORWARD TO BRINGING NEW SPECIFIC INITIATIVES TO THIS GROUP IN MONTHS TO COME FOR YOUR ADVICE AND CONSIDERATION. THANKS AGAIN FOR THE OPPORTUNITY TO SPEAK TO ALL OF YOU AND I'LL END THERE AND LOOK FORWARD TO COMMENTS AND QUESTIONS. >> THANK YOU. >> THANK YOU. REALTY CREE IMPORTANT. DOES ANYBODY HAVE ANY QUESTIONS FOR SATISH? -- REALLY IMPORTANT QUESTIONS. NONE? NO QUESTIONS, SATISH BUT OBVIOUSLY THE GROUP IS GOING TO WELCOME YOU WHEN YOU COME BACK TO RUN BY US NEW CONCEPTS AND SOME IDEAS FOR THE FUTURE. THANKS AGAIN. >> THANK YOU ALL SO MUCH. WE'LL MOVE ON TO CONCEPTS AND WE'LL VOTE OR CONCUR OR NON CONFER AND DURING THE VOTING I'LL ASK HOW MUCH MEMBERS DISAPPROVE NON-CONCUR AND HOW MANY ABSTAIN. WHEN ASKED PLEASE RAID YOUR HAND OR STATE YOUR NAME SO WE CAN -- RAISE YOUR HAND OR STATE YOUR NAME SO WE CAN COUNT THE VOTE. WITH THAT WE'LL MOVE TO THE FIRST CONCEPT K9 CANCER IMMUNE THERAPY NETWORK. DR. SOME SOM -- DR. SOMMERS WILL PRESENT. >> THANK YOU FOR THE OPPORTUNITIES TO PRESENT THE NEW CONCEPT K9CIN. THE REASON THEY'RE GOOD IS THEY'RE SPONTANEOUS AND THE SIMILAR TO HUMANS AND ARISE IN A HOST AND DOGS HAVE SHORTER LIFE SPAN AND EXPRESSED DISEASE PROGRESSION TIME LINE TIME LINE ALLOWING FOR FASTER CLINICAL TRIALS. WE HAVE THE ABILITY TO TEST INVESTIGATIONAL DRUGS IN EARLY OR MINIMAL DISEASE STATES. THERE'S OFTEN NEWER STANDARD OF CARE AND DIFFERENT REGULATORY REQUIREMENTS ALLOWING US TO INITIATE CLINICAL TRIALS MORE QUICKLY AND HIGH DEGREE OF COOPERATION FROM PET OWNERS WHO WANT TO HELP NOT ONLY THEIR DOG BUT OTHER DOGS AND PEOPLE WITH CANCER. IS THE CANCER MOONSHOT FUNDED A K9 IMMUNOTHERAPY NETWORK IN 2019. CALLED PRECLINICAL MEDICAL NETWORK FOR PRE CLINICAL TRIALS AND. AT THE THREE YEAR OF THE FIVE YEAR PERIOD, GOING TO REPORT ON TWO ADVANCES. ONE GROUP WAS DOING TUMOR MICROENVIRONMENT MODULATORS AND ONE COMBINATION LED TO THE PHASE 1 CLINICAL TRIAL IN PEDIATRIC SARCOMA. OTHER USED A COMBINATION OF A NEW CD200 CHECKPOINT TARGET PEPTIDE WITH VACCINE AND THE DATA FROM THE DOGS CONTRIBUTED TO SUPPORT THE ADULT GLIAL BLASTOMA AND RELEASED AN IMMUNOONCOLOGY PANEL ALLOWING FOR HARMONIZED IMMUNE MONITORING AMONG CENTERS AND ADDRESSES SOME LIMITATIONS IN THE K9 FIELD OF LIMITED FLOW CYTOMETRY REAGENTS. THAT WAS A LOT OF PROGRESS IN ONLY THREE YEARS. WE FEEL WE NEED NEW FUNDING AND A NEW NETWORK. THIS IS A DEVELOPING FIELD. NOT ALL CANCER TYPES WERE COVERED FOR EXAMPLE BLADDER AND MAMMARY AND THYROID CANCER NOT COVERED. WE'RE MISSING COMBINATIONS. DOGS DOGSES -- DOGS ARE A GRADE MODEL FOR RADIATION AND THERE WAS LIMITED CAR T CELL OR NK CELL THERAPIES AND NO PD1 OR CTLA .4 IN IMMUNE BODY THERAPIES BECAUSE K9 REAGENTS HAVE NOT BEEN AVAILABLE AND BEING MADE AND BECOMING AVAILABLE NOW AND WE FEEL WILL LIKELY BE AVAILABLE BY THE TIME THE RFA WILL BE FUNDED. WE SUPPORTED K9 LITERATURES IN NATURALLY OCCURRING TUMORS ALLEN OR WITH OTHER MODALITIES WITH THE END GOAL OF INFORMING CANCER THERAPEUTICS IN HUMAN PROVIDING AN OPPORTUNITY FOR NCI TO TAKE A LEADERSHIP ROLE AND BUILD ON THE INITIAL INVESTMENTS. WHEN I DID A PORTFOLIO ANALYSIS OF K9 IMMUNOTHERAPY STUDIES VERSUS MOUSE IMMUNOTHERAPY STUDIES THERE WERE CANCER MOONSHOT K9 IMMUNOTHERAPY GRANTS INCLUDED IN THE MOON SHOTS AND WE RECEIVED APPLICATIONS AND FUNDED FIVE AND FIVE U24 AND FUNDED ONE. SO THERE ARE PLENTY OF GROUPS OUT THERE READY, WILLING AND ABLE TO DO THIS KIND OF RESEARCH. THE UL 1 SHOULD PROVIDE PUBLISHED OR PRELIMINARY DATA TO SUPPORT CLINICAL TRIALS AND STUDIES IT MUST INCLUDE THERAPEUTIC MODULATION OF THE TUMOR MICROENVIRONMENT OR DIRECT DESTRUCTION OF THE CANCER AND SHOULD INCLUDE AMINO PHENOTYPES OF BLOOD AND OTHER RELEVANT TISSUES. WE'LL PRIORITIZE TUMOR MICROENVIRONMENT THERAPY WITH OTHER THERAPIES SUCH AS TARGETED OR OTHER IMMUNOTHERAPIES. AND PROTOCOLS WITH CONTENT TIMING AND SEQUENCE TO THOSE INFORMED LANCELATION -- TO AND WE WILL ALSO PRIORITIZE APPLICATIONS THAT INCLUDE TUMOR DNA SEQUENCING AND TRANSCRIPTOMICS AND OTHER OMICS. EXAMPLES ARE A FOCUSSED K9UPPO THERAPY CLINICAL TRIAL TRIAL BASED ON PRELIMINARY DATA OR A LEAKER FOCUSSED CLINICAL TRIAL AND WE HAVE BOTH IN THE CURRENT NETWORK. ANOTHER IS A CAR T CELL THERAPY WITH OR WITHOUT ADDITIONAL OR COMBINATION THERAPIES. FOR THE U24 THEY'LL COORDINATE IN-PERSON STARING COMMITTEE MEETINGS AND IT WILL HAVE NOT ONLY THE UL 1 AND U24 SITES BUT EXPERT ADVISORS AND NCI EXTRAMURAL AND INTRAMURAL STAFF AND AMY LEBLANC FROM THE ONCOLOGY PROGRAM HAS BEEN AND WILL CONTINUE TO BE INVOLVED IN THE NETWORKS AND IT WILL HARMONIZE CLINICAL DATA TO THE COMMENTS AND DEVELOP SOPs FOR THE VETERINARY COMMUNITY AT LARGE AND I DON'T HAVE TE TIME TO DISCUSS I CDC AND IT'S TO HOUSE K9 CANCER DETE AND IMAGING -- DATA AND IMAGING PHENOTYPING DATA AND LOTS OF DATA. THE U24 WILL HERE MARK FUNDING TO PROJECTS PROPOSING INTRANETWORK COLLABORATIONS OR PROJECTS NEARING TRANSLATION TO HUMANS. AND PROGRAM STAFF WILL HAVE FINAL APPROVAL OF THE PRIORITIZATION OF THE DISCRETIONARY PROJECTS. THE BUDGET IS $2.7 MILLION SO FOR SIX AWARDS IT'S $3.42 BILLION -- MILLION AND FOR THE TOTAL FIVE YEAR COST $17.1 MILLION. FOR THE RFA MECHANISM IS INEFFICIENT REPRESENTATION IN THE NCI PORTFOLIO FOR THE SPECIAL EMPHASIS PANEL THE KIND OF APPLICATIONS GO TO ALL THE SUDDENY SECTIONS AND THERE'S OFTEN NORT ENOUGH EXPERTISE TO GET A GOOD REVIEW. AND FORAY COOPERATIVE AGREEMENT MECHANISM WE WILL HAVE STAFF TO FACILITATE CONDUCT OF THE K9 CLINICAL TRIALS BUT TO FACILITATE DATA SHARING WITHIN THE COMMUNITY AND TO THEI CDC AND THIS -- THE ICDC AND THIS HAS GONE WELL IN THE FIRST NETWORK AND CAN COORDINATE AMONG THE U01 SITES WHICH IS IMPORTANT. ALF CONSULTATION WITH NCI IT CAN ACCELERATE PROGRESS OF ONE OR MORE GROUPS WITH THE EARMARKED FUNDING. AND SECOND STAGE COMBINATION AND CLINICAL TRIALS CAN GAIN FROM INFORMATION FROM NOT ONLY THEIR FIRST STAGE TRIALS BUT OTHERS IN THE UL 1 NETWORK. AND STFS JULY WITHOUT COMES -- SUCCESSFUL WITHOUT COMES TO A PHASE 1 CLINICAL TRIAL OR TRANSLATION TO A TRIAL AND FOR CELLS LIKE CAR T CELL THERAPIES AND ESTABLISHING A BASELINE THERAPEUTIC CONDITIONS RELEVANT TO HUMANS WITH VARIED COMBINATIONS CAN BE TESTED. AND DATA TO THE ICDC AND FINALLY ADVANCE CONTINUE NCI'S INVESTMENT IN THE UNDER DEVELOPED MODEL. WITH THAT I'D LIKE TO THANK THE MEMBERS OF MY TEAM AND TOBY HO HOATS WHO WROTE IT AND HAPPY TO TAKE YOUR QUESTIONS. >> OVER TO BOB FOR DISCUSSION. >> THE COMMITTEE MET WITH THEM A FEW WEEKS AGO AND WE'RE VERY ENTHUSE YAS. THIS IS WORKING WELL TO DRIVE THE DEVELOPMENT OF A NEW AND UNIQUE MODEL AND VETERINARY CANCER RESEARCH AND THIS IS HELPING TO BRING THAT FORWARD. THESE ARE NOT JUST BIG MICE OR FUZZY HUMANS. IT'S A DIFFERENT MODEL THAT PROVIDES NEW OPPORTUNITIES. WE'RE TALK ABOUT PEOPLE'S PETS NOT BEAGLES BRED FOR THIS PURPOSE. THEY GET CANCER A LOT AND THE TYPES OF CANCERS THEY GET ARE SIMILAR TO HUMANS AND THEY LIVE IN THE ENVIRONMENT AS WE DO. SO PRECINCT TURNED OUT TO BE HIGHLY SUCCESSFUL AND VERY PRODUCTIVE AND THIS IS THE NEXT OPPORTUNITY FOR THE NCI TO ACCELERATE THAT WORK AND NEW REAGENT NEEDED TO MAKE THE WORK THE MOST IMPACTFUL. I PERSONALLY AGREED FOR THE NEED FOR AN RFA BECAUSE OF THE SPECIALIZED NATURE OF THE WORK AND I'LL SEE IF OTHER MEMBERS WANT TO ADD ON. I THINK I THINK THE RESEARCH PROGRAM TAKES ON A WHOLE LEVEL OF IMPORTANCE AND THIS CAN BE A MORE POTENTIALLY IMPACTFUL PROGRAM AND BUILDING ON THE INITIAL FUNDING. I AGREE WITH BOTH COMMENTS. I THINK IT'S AN IMPORTANT FOCUS FOR THE NCI TO SUPPORT. I LIKE THE IDEA OF THE MOVE THAT WILL COME ABOUT OF GENERATING THE NEW REAGENTS WHICH I THINK ARE IMPORTANT. UNDERSTANDING THE OUTCOMES ON A MOLECULAR AND CELLULAR BASIS AND I'M VERY MUCH IN FAVOR OF THIS. >> THANK YOU. I WANTED TO INVITE THE PANEL IF THERE'S ANY QUESTIONS BEFORE WE MOVE TO VOTING. >> I HAVE A QUESTION FOR BOB AND KEITH AND I'M SUPPORTIVE OF THE GENERAL IDEA AND LIKE THEM SUPPORTING AN RFA BUT YOU ALREADY HAVE A NETWORK THAT WORKS SO WHY SHOULDN'T THIS BE FOR RFO1s TO PROPOSE INNOVATION AND JOIN THAT GROUP? WE HEARD ABOUT THE RO1 PAY LINES. WHY CREATE ANOTHER U WHEN WE'VE GOT A U UP AND RUNNING AND WORKING PROVIDING AND ASK THE COMMUNITY TO SUBMIT RO1s AND JOIN IN AND DO IT OVER A YEAR OR TWO AND GET THE BEST SCIENCE IN THIS DOMAIN INTO THE EXISTING NETWORK? I DON'T GET IT. >> I MAY NOT HAVE MADE THIS CLEAR. THE CANCER SMOON -- MOONSHOT IS MEANT TO CONTINUE WEN THE CURRENT NETWORK ENDS. I'D BE HAPPY TO TALK ABOUT MORE FUNDING BUT THIS NETWORK WOULD REPLACE THE NETWORK WHICH WILL BE ENDING IN 2022. I WANTED TO ASK A QUESTION REGARDING HOW THIS IS WORKING WITH PARTNERSHIPS WITH VETERINARY CARE. WHAT ARE THE REGULATORY ISSUES WE NEED TO CONSIDER IF AT ALL? IS THERE ANY STANDARDIZATION? AND THINKING ABOUT APPROACHES TO CLINICAL CARE AND THERE'S A LOT OF THINGS THAT NEED TO BE OBVIOUSLY MONITORED AND CODIFIED IN A WAY THAT ALLOWS ONE TO GET A MEANINGFUL SET OF CONCLUSIONS. >> I'M GOING TO CALL ON AMY LEBLANC WHO I THINK CAN ANSWER YOUR QUESTION BETTER THAN I CAN. >> YEAH, HIGH. THAT'S A GOOD POINT. I THINK THAT ONE THING TO REMEMBER IS THAT THESE ARE TRIALS AND DRUGS AND AGENTS AND MECHANISMS THAT SUPPORT AGENTS FOR HUMAN USE AND THERE'S ANIMAL CARE APPROVALS AT THE INSTITUTIONAL LEVEL AND ASSURANCES ON QAQC FOR THE PRODUCTS BEING STUDIED BUT NOT REGULATED BY THE CENTER FOR VETERINARY MEDICINE IN AN APREFL OR REGULATORY WAY DID -- IN AN APPROVAL OR REGULATORY WAY AND FOR BUY LOGICS THE USDA MAY BE INVOLVED FOR SHIPPING AND RECEIPT OF SAMPLES AND THINGS BUT THEY'RE NOT AGENT FOLLOWING A VETERINARY PATH >> MAYBE I'M CONFUSED THEN BECAUSE I HEARD THE PURPOSE WAS TO EXPEND THIS AREA OF INQUIRY TO TUMORS NOT CURRENTLY COVERED BY PRE SPIRCHKT AND TO LOOK AT COMBINATIONS THAT INCLUDE -- PRECINCT AND TO LOOK AT COMBINATIONS AND MAYBE I DIDN'T HEAR IT. >> I'M TELLING YOU WHAT WE WOULD PRIORITIZE AND WHY WE'RE NOT DONE AFTER FIVE YEARS. THERE'S STILL A LOT TO DO. IN TERMS OF -- DOES THAT ANSWER? >> NO, BECAUSE YOU SAID IT'S THE CONTINUATION OF PRECINCT WHEN MOONSHOT RUNS OUT AND THAT'S WHAT I'M HEARING. >> I THINK THE MECHANISM WILL REPLACE IT BUT DOESN'T NENE THE SCOPE WILL BE -- MEAN THE SCOPE WILL BE IDENTICAL. WE'RE REPLACING THE MECHANISM THAT EXISTED OUTSIDE OF MOON SHOT BUT I THINK THE IDEA WILL BE TO BRING APPLICATIONS THAT ADDRESS DIFFERENT TUMOR SITES. >> THE NCI MISSION IS TO PRIORITIZE CANCERS COMMON IN HUMAN AND DOGS IF IT'S A ONE OR THE OTHER. IT'S PROBABLY NOT GOING TO GET DONE. IT WILL DEPEND ON WHAT APPLICATIONS WE GET AND THE FUNDING IS ENDING AND WE'RE STARTING AGAIN AND WE'LL GO WITH WHAT APPLICATIONS WE HAVE AND WHAT ONES WE THINK ARE MOST SCIENTIFICALLY SOUND AND APPLICABLE TO HUMAN CANCER. >> WHAT IF THERE'S A LOT OF PROGRESS MADE IN SARCOMA OR MELANOMA YOU ADDED YOU WANTED TO HAVE DIFFERENT TUMOR MODELS. WHAT ABOUT THE ONES THAT ARE DOING WELL ALREADY. WILL THIS BE PART OF THIS? >> YES. THOSE ARE OBVIOUS CHOICES TO MAKE PROGRESS APPLICABLE TO HUMANS. I WOULD THINK THEY WOULD MAKE UP THE MAJORITY. FOR THE PRECINCT WE ADDED AUXILIARY MEMBERS WHO HAD GRANTS OR SUPPORT TO DO OF 9 WORK BUT -- K9 WORK BUT NOT PART OF THE UL1 SYSTEM. THEY PARTICIPATED IN THAT AND CONTRIBUTED. THERE WAS A BLADDER CANCER AND A MAMMARY CANCER AND THAT HELPED ROUND IT OUT. I THINK IF THE BEST PROJECTS WERE ONES THAT WERE ALREADY REPRESENTED IN PRECINCTS AND WE FELT NOT ENOUGH WAS DONE THOSE WERE THE ONES TO GET FUNDED. IF THIS SCIENCE POINTS TO THOSE WE'VE ALREADY DONE THEN WE'LL CONTINUE THAT. >> I'M SUPPORT. >> THE PEOPLE WHO WERE COMPETING OUT OF VETERINARY SCHOOL I IMAGINE THERE'S NOT A LOT OF DOGS TO BE TESTED IN TECHNICAL TRIALS AND MAYBE I MISUNDERSTOOD. >> CURRENTLY THEY'RE ALL ASSOCIATED WITH VETERINARY SCHOOLS. >> THEY CAN HAVE OTHER SITES AND SOMETIMES THEY HAVE PEOPLE IN THE COMMUNITY SO THEY DO TRY TO BRANK OUT BUT THEY'RE FROM VETERINARY SCHOOLS. -- BRANCH OUT. >> I WANTED TO MAKE A MORE GENERAL COMMENT. PRECINCT IS ONLY THE FIRST OF THE MOONSHOT PROGRAMS THAT ARE STARTING TO TRANSITION. YOU'LL SEE THE PROGRAMS FUNDED IN THE MOONSHOT AND AS THEY'VE EVOLVED WILL COME BACK TO BE FUNDED IN THE RPG. WE'RE IN THE PROCESS OF ASSESSING WHICH OF THOSE PROGRAMS ARE GOING TO GO FOR TO BE REMOVED, WHICH WILL EVOLVE INTO A SLIGHTLY DIFFERENT FORM AND WHICH WE'LL TERMINATE AND CLAIM SUCCESS AND GO ON. THIS IS THE FIRST OF THEM NOW TRANSITIONING AND I THINK WILL COME BACK TO YOU IN THE FUTURE TO TALK ABOUT OUR OVERALL STRATEGY FOR THAT BUT YOU CAN EXPECT TO SEE A NUMBER COMING TO THE BSA TO ANSWER KEVIN'S QUESTION ABOUT WHY YOU'RE NOT SIMPLY CONTINUING IT AS A RENEWAL BECAUSE IT'S MOSQUE INTO THE RPG. I HOPE THAT HELPS TO RESOLVE SOME ISSUES AROUND THIS PARTICULAR PROPOSAL AND ALSO ONES IN THE FUTURE. >> MAKES SENSE TO ME BUT I ASSUME BASED ON YOUR COMMENTS WE WON'T BE HEARING A PROPOSAL TO CONTINUE PRECINCT IN THE FUTURE. THIS IS THE PRECINCT SUCCESSOR WE'RE TALKING ABOUT THAT CORRECT? >> CORRECT. >> IT WOULD HAVE BEEN HELPFUL TO HAVE THAT MADE CLEAR IN THE PRESENTATION. >> IT WON'T BE THE SAME ALL THE TIME AND THIS WILL NOT BE THE LAST TIME THIS ISSUE COMES UP. >> SO WOMEN THAT IT WAS A GREAT -- SO WITH THAT IT WAS A GREAT DISCUSSION. I THINK WE'RE READY TO FOR A MOTION. DOES SOMEONE WANT TO CALL A MOTION? >> TO REMIND YOU, THIS IS A NEW RFA. WE'LL VOTE OR DISAPPROVE. >> I MOVE APPROVAL. >> SECOND? >> SECOND. >> HOW MANY ARE DISAPROVING? >> ONE COMMENT SINCE WE'RE IN A DISCUSSION PERIOD. WITH THE POINT OF MOONSHOT CONTINUAL SUPPORT AND ILIKE THE IDEA OF POTENTIALLY TAKING A 30,000 FOOT VIEW OF THE COLLECTION OF MOONSHOT INITIATIVES SO WE ARE LOOKING AT THE EFFORTS AND PRIORITIZING THEM IN AS MUCH OF A GROUPING AS WE CAN RATHER THAN A FIRST COME, FIRST SERVE KIND OF APPROACH. JUST A THOUGHT FOR APPROACH GOING FORWARD. >> IT WOULD BE NICE TO KNOW HOW LONG EACH INITIATIVE IS PLANNED. IS THE IDEA YOU GOT THE MOON SHOT AND FIVE YEARS TO TRANSITION IN ESTABLISH AN AREA AND NOT TO RENEW THIS OR AT LEAST SOME IDEA OF HOW LONG THESE WILL CONTINUE? IT WOULD ALSO BE GREAT TO HEAR -- >> I THINK YOU'RE BEING ASKED TO PRESENT SOMETHING THAT GIVE US A FRAMEWORK TO THINK ABOUT THESE THINGS WHICH NED MENTIONED WAS PLANNED NOT SURE WHETHER THE NEXT MEETING BUT IT WILL BE VERY HELPFUL. >> TO YOUR POINT JUST REMEMBER THAT THESE DIFFERENT INITIATIVES WERE STARTED OVER MULTIPLE YEARS. SOME ARE STILL GOING TO GO ON BEYOND '23. OTHERS HAVEN'T GOTTEN TO THE POINT OF NOT KNOWING WHAT THEY'RE GOING TO DO AND YOU CAN GIVE THE OVERVIEW OF YOUR BEST GUESS BUT IT'S STILL EVOLVING. >> UNDERSTOOD, THANK YOU. >> WITH THAT WE NEED TO STICK TO TIME. WE'RE ALREADY A LITTLE BIT LATE. I WILL ASK THOSE WHO IS THERE ANYBODY THAT IS GOING TO VOTE TO DISAPPROVE? >> READY TO MOVE FORWARD? >> LET'S MOVE. >> LET'S MOVE. >> SO THE NEXT NEW RFA CONCEPT IS RADIATION ONCOLOGY AND BIOLOGY INTEGRATION NETWORK. DOCTORS MIKE ESPEY AND DR. DRDR. BUCH DR. BUCHSBAUM. >> HELLO. I'LL BE PRESENTING THE FIRST HALF OF THE TALK AND THEN DR. MIKE ESPEY WILL TAKE OVER AND IT'S ABOUT RADIATION ONGY BIOLOGY INTEGRATION NETWORK OR ROBIN AN RFA PRESENTATION. BEFORE WE GO TO THE END OF THE TALK WE WANTED TO THANK EVERYONE INVOLVED AND DEMONSTRATE THE GROUP EFFORT AND FROM THE RESEARCH PROGRAM BUT MANY OTHER GROUPS AT NCI LOOKED AT THIS PRESENTATION AND CONTRIBUTED SIGNIFICANTLY. WE WOULD ALSO LIKE TO THANK OUR BSA MENTORS. IT REPRESENTS GAP ANALYSIS AND UNMET NEED. 50% OF ALL RECEIVE RADIATION THERAPY BUT FEW DATA IS COLLECTED FOR PATIENT RESPONSES TO RADIATION THERAPY. AT CANCER DIAGNOSIS WE'RE GOOD AT SAMPLING AND IMAGING AND FURTHER RESEARCH ANALYSIS AND NOT GOOD AT COLLECTING OR ANALYZING DATA. THIS SHOWED A RELATIVE ABSENCE OF INDUSTRY AND INTEGRATED NCI PROGRAMS TO SUPPORT DATA COLLECTION AND HYPOTHESIS TESTING THROUGH RADIATION THERAPY. SO TO ADDRESS THIS DR. SHARPLESS ASKED AN ADD AHOCK WORKING GROUP -- AD HOC GROUP AND ANALYZED THE SITUATION NATIONALLY. OUTSIDERS CAME BACK AFTER PEER REVIEW WITH THE FOLLOWING RECOMMENDATION THE OVERALL SUMMARY RECOGNITION WAS A CONSORTIUM TO ADVANCE THE STUDY OF THE BIOLOGIC MECHANISMS THROUGH PRE CLINICAL RESEARCH AND TRANSLATIONAL RESEARCH STUDIES TO DEVELOP PROMISING RADIO THERAPEUTIC APPROACHES WITH SPECIFIC POINTS ON THE PRIORITIZATION AND SUPPORT OF RESEARCH TO INVESTIGATE THE BIOLOGICAL CONSEQUENCES OF RADIATION TREATMENT AND TO SUPPORT LONGITUDINAL COLLECTION OF BIO SPECIMENS BEFORE ON TREATMENT AND AFTER RADIATION THERAPY AND TO SPECIFICALLY TO DEVELOP A MULTI DISCIPLINARY WORKFORCE TO BEST INFORM CLINICAL RADIATION ONOLOGY STUDIES. THE FOUNDATION OF THE CONCEPT A DEEP MULTI DIMENSIONAL CHARACTERIZATION TRIAL IN RADIATION THERAPIES. THERE'LL BE SMALL STUDIES, SMALL COHORTS UNDERGOING RADIATION THERAPY BEFORE OR AFTER TREATMENT FORMAT. SO A BEFORE TREATMENT ASSESSMENTS PRETREATMENT OR DURING THE COURSE OF THERAPY AND AFTER TREATMENT BOTH IN HOURS, DAYS AND MONTHS. WE HOPE TO GET RESPONSE TO RADIATION THERAPY. EACH SERVES AS THEIR OWN CONTROL CHARACTERIZATION OF THE RT RESPONSES WILL BE POSSIBLE AND MULTI MODAL HIGH CONTENT ANALYSIS WILL BE PERFORMED. >> POSSIBLE TYPES OF INVASIVE AND NON-INVASIVE INCLUDE BYPASSES AT TUMOR AND BLOOD AND FUNCTIONAL GEE -- GENOMIC AND MRI/CT AND PET SCANS AND PATIENT REPORTED OUTCOME AND OTHER METADATA. POSSIBLE CANCERS MOST AMENABLE INCLUDE AREAS WHERE THERE IS SIGNIFICANT NEED FOR IMPROVEMENT IN OUTCOME AND INCLUDE POSSIBLY GASTROINTESTINAL TUMORS AND HEAD AND NECK AND SARCOMA AND PEDIATRIC AND LUNG CANCERS. THE DATA DENSE CHARACTERIZATION STUDIES ARE COMMONLY USED IN EARLY PHASE CLINICAL TRIALS WHICH ALLOWS FOR TREATMENT RESPONSES AND ADVANTAGE FOUR SERIAL SAMPLING AND DEVOTED PATIENT VOLUNTEERS AND CAN BE COMPLETED RAPIDLY AND ALLOW FOR TEST AND PROGRESS. AN EXAMPLE IS THE HUMAN NETWORK AND THE ATLAS MULTIPLE TYPES OF CANCER COMBINING MULTIPLE APPROACHES THE STUDIES ARE LONGITUDINAL AND HYPOTHESIS GENERATED NON-MARKER VALIDATION DRIVEN. THE POINT OF THE SLIDE IS TO DEMONSTRATE THESE SMALL TYPES OF STUDIES AN IMPACT THE STANDARD OF CARE LONGITUDINAL DATA EXISTS THAT HAVE BEEN SYSTEM ACALLY APPLIED AND MULTI-MODAL DATA DENSE APPROACH FEASIBLE IN AN RT SECT AND BLOOD AND BIOMARKER BASED ARE SHOWN IN THE CATEGORY. IN CONDITION COLLUSION BIOLOGY NETWORK OR ROBIN PROGRAM SAY NETWORK OF U54 CENTERS THAT BEST ACHIEVE THE FOLLOWING GOALS COLLECT DATA THAT DESCRIBES THE BIOLOGICAL BASIS FOR RESPONSE AND SPUR INNOVATION FOR A VIEW OF RADIO THERAPY IN TUMORS AND NORMAL TISSUE AND GROW A SCIENTIFIC WORKFORCE WITHIN THE CANCER COMMUNITY AT THIS POINT I'D LIKE TO HAND IT TO DR. DR. ESPEY. >> THROUGH THE RADIATION ONCOLOGY AND VIROLOGY CENTERS OR ROBBINS WE SEEK TO EFFECTIVELY LINK CLINICAL RADIATION ONCOLOGY WITH RESEARCH DEEMED AT CHARACTERIZATION THE TREATMENT RESPONSES. EACH U54 WILL BE DRIVEN BY A CENTRAL HYPOTHESIS AS RECOMMENDED BY THE CTAC RADIATION ONCOLOGY WORKING GROUPS. THESE INCLUDE INTEGRATION OF ORTHOGONAL MEASURES OF RT RESPONSES AND PROXIMAL TO RADIATION THERAPY AND CAN INFORM ON THE BASIS OF LATE EFFECTS. REGARDING MULTI SCALE THEY CREATE A HOLISTIC VIEW OF RADIATION THERAPY WITH A BREADTH OF DATA THAT LINKS CELLULAR AND PATIENT-LEVEL SCALES. A DEDICATED WORKFORCE COMPONENT I'LL COVER ON THE NEXT SLIDE. HERE ON THE RIGHT YOU SEE IT DEPICTS THE STRUCTURE AS WE ENVISION IT. THE FOUNDATION OF EACH ROBIN U54 WILL BE STRUCTURED TO COLLECT MULTI MODAL DATA ALONG THE CONTINUUM AND THEY FEED INTO INTERDISCIPLINARY RESEARCH PROJECTS THAT FOCUS ON OBJECTIVE MEASURES OF PATIENT RADIATION RESPONSES IN LINE WITH TESTING THE CENTER'S CENTRAL HYPOTHESIS. THE WAY WE ENVISION THIS IS THE FOUNDATION OF THE ROBIN CENTER WORKS WITH THE RESEARCH PROJECTS. IMPORTANTLY THE COARSE ARE A SUPPORTING -- COURSE ARE SUPPORTING IMAGERY. BECAUSE THIS A DATA INTENSIVE PROGRAM A POSITION. AND OTHERS ARE ACROSS TRAINING CORE TO FACILITATE THE WORKFORCE DEVELOPMENT IN LINE WITH THE CTAC WORKING GROUP AND WITHIN THE RESEARCH CENTER WILL BE A TOOL FOR WORKFORCE DEVELOPMENT AND PROMOTES EXCHANGE OF IDEAS AND SKILLS ACROSS THE NETWORK. ON THIS SLIDE WE HAVE THE LANDSCAPE VISION OF THE ROBIN PROGRAM. AND EACH CENTER IS GUIDED BY UNIQUE OVER ARCHING THEME. THE AND AND THE PROJECT WILL BE FACED IN THE YEARS OF 2-5 AND COOPERATIVE OPPORTUNITIES SOMETHING FOUND TO BE EFFECTIVE AS A CATALYST FOR STRENGTHENING NETWORKS. AND GOVERNANCE THROUGH THE STEERING COMMITTEE TO FACILITATE COORDINATION OF TRANS NETWORK ACTIVITIES INCLUDING TOPICAL TEAM SCIENCE SUB GROUPS THE EXAMPLES OF WHICH ARE SHOWN BLOW. IN PANEL D SHOWS THE BROADER STRUCTURE TO LEVERAGE EXISTING NCI INFRASTRUCTURE INCLUDING ALLIANCES WITH OTHER PROGRAMS AND THE CENTER FOR CANCER TRAINING. LIKEWISE WE SEEK TO PROMOTE ENGAGEMENT WITH OTHER ACTS BRINGING IN COMPLIMENTARY TOOLS. AND THE BUDGETS BE APPROXIMATELY $2 MILLION IN TOTAL COSTS NOT INCLUDING THE 20% POLICY CUT WITH A TOTAL BUDGET OF $6 MILLION PER YEAR OVER THE FIVE YEAR PROJECT PERIOD TO SUPPORT A NETWORK OF THREE ROBIN CENTERS. THIS SHOWS OUR METRICS FOR SUCCESS. WE WANT TO DEVELOP A ROBUST CHARACTERIZATION KNOWLEDGE BASED THERAPY RESPONSES THAT DESCRIBES THE TRAJECTORY OF INDIVIDUAL PATIENTS WHO ARE UNDERGOING RADIATION TREATMENT LONGITUDINAL AND DYNAMIC DATA. IT'S DATA COLLECTED FOR RESEARCH SPECIMENS DURING THE RADIATION TREATMENT CONTINUUM. THIS WILL ENABLE TESTING OF NEW HYPOTHESIS THAT RELATE TO THE BIOLOGICAL RESPONSE TO THE PHYSICAL DOSE DELIVERED AND SERVE AS A PNEUMLATION POINT THROUGH THE -- NUKE -- NUCLIZATION POINT AND WE ANTICIPATE THIS WILL HELP ENABLE DEVELOPMENT OF THE NEXT GENERATION OF INTERDISCIPLINARY SCIENTISTS AND HAVE A RIPPLE AFFECT ON K AWARDS AND 232 TRAINING GRANTS. AND THIS CONCLUDES OUR PRESENTATION AND HAPPY TO TAKE QUESTIONS AFTER THE DISCUSSION. >> THANK YOU FOR A GREAT PRESENTATION. THEY SERVED ON ME FOR THE SUBCOMMITTEE AND WE HAD A PRODUCTIVE ZOOM CALL WITH THE COMMITTEE MEMBERS HAD SUPPORT AND WE WANT TO PROVIDE SAMPLES TO RESPONSE. THE CONCEPT MADE A CONVINCING CASE WITH THE DEEP PROFILING ARE ON TAP IN THE STUDY IN THE CONTEXT OF CLINICAL SAMPLES. WE UNDERSTAND THE MAJORITY OF THE FUNDS IS IN TECHNOLOGY DEVELOPMENT AND THE ROBIN CONCEPT PUSHES US TOWARDS AN OPPORTUNITY TO DE VIVE AND APPLY NEW BIOLOGICAL KNOWLEDGE IN THE RADIATION TREATMENT AND COMBINATION WITH OTHER TREATMENTS. THE AND I WAS PLEASED TO SEE SOME HIGHLIGHTS AND DISCUSSED THE ROLE OF SPOTLIGHTING THE HI HYPOTHESIS OF THE RADIATION RESPONSE AND THE REQUIREMENT OF THE CROSS TRAINING CORE. WE WERE DISMAYED TO LEARN ABOUT THE TRAINING GRANT FOR RADIATION SCIENCES BUT THAT'S A TOPIC FOR A DIFFERENT TIME AND DISCUSSED IT'S OFTEN GIVEN IN COMBINATION SO ANY RESPONSIVE AWARD WOULD NEED TO MAKE EXPLICIT TO UNVIVED AFFECTS WITH RADIATION THERAPY ALONE. AND FINALLY WE EMPHASIZED THE NEED TO DATA REPOSITORY PLAN AND THE CONSIDERATION OF SUPPLEMENTAL FUNDS FOR OTHERS TO EXPLOIT THAT DATA. WITH THAT I WELCOME COMMENTS FROM ANY COLLEAGUES. >> THANK YOU. >> THE ARGUMENT THAT RADIATION ONCOLOGY IS RESEARCH FUNDED WAS CLEARLY MADE AS A GREAT INTERVENTION. THAT'S DISCUSSION FOR ANOTHER DAY. >> ADDITIONAL COMMENTS? >> THAT CONCEPT IS ECHOED FOR INCREASING FUNDING RADIATION RESEARCH. IS THERE DISCUSSION OU THE U54 CENTERS MAY INTERSECT WITH THE NR AND VAST DATABASES OF TISSUE FOR PATIENTS WHO HAVE UNDER GONE RADIO THERAPY? I WANT TO KNOW ABOUT THE CONNECTION THERE AND IF THAT WAS DISCUSSED. >> IT WASN'T BUT COLLECT TISSUE ON SUBSETS OF THEIR PATIENT WOULD BE APPROPRIATELY DURING AND AFTER THE COURSE OF TREATMENT LIKE DATABASES CURRENTLY IN PLACE IN THE ADULT SPACE AND AFTER TREATMENT BUT IT'S EXTREMELY RARE IF NOT ALMOST IMPOSSIBLE TO FIND DURING TREATMENT BIOLOGY WHERE THE RESPONSES MAY BE IMPORTANT FOR FURTHER DISCOVERIES. YES, THAT COULD BE DONE AND I THINK IT WOULD BE REASONABLE PLACE TO COLLABORATE WITH THE CENTERS. >> DOES THAT ANSWER THE QUESTION? >> I THINK THERE'S OVERLAP THERE, RIGHT WITH SOME OF THE TROONSLATIONAL COMMITTEES IN THE NRG VERSUS WHAT THESE CENTERS WOULD LIKE TO ACHIEVE AND HOW TO MAXIMIZE THE OVERLAPPING GOALS. >> UNDERSTOOD. IN MY LIMITED ABILITY TO HEAR THE CONVERSATIONS WITHIN THE PROTOCOLS AND MY ROLE AS A FORMER CIG SIGNIFICANT INVESTIGATOR, THERE WERE NEVER FUNDS IN THE PIPELINE TO DO THE KINDS OF DAENS DATA COLLECTION. I WANT TO BE CLEAR ON THE DENSE DATA COLLECTION AND THE IDEA OF DAILY DATA. WE DON'T HAVE THAT KIND OF FUNDING STRUCTURE IN ANY OF THE NRG OR COG TRIALS AT THIS TIME. >> THERE'S THE NOTION OF HYPOTHESIS TESTING IS IMPORTANT TO THE ROBIN PROGRAM SO A LOT OF THE SAMPLES COLLECTED WITHIN THE NRG DON'T NECESSARILY FIT INTO THE OVERALL CONCEPT THE U54 WOULD HAVE OF INTEGRATING SEVERAL PROJECTS THAT WOULD BE COMPLIMENTARY TO DRIVE OUT THE HYPOTHESIS TO UNDERSTAND MEC MISTCALLY WHERE THE -- MECHANISTICALLY WHERE THEY OCCUR AND A HOLISTIC VIEW POINT. >> I LIKE THE IDEA OF THE SMALL TRIALS BUT MANY CANCERS ARE BEING TREATED WITH COMBINATIONS OF RADIATION AND CHEMOTHERAPY. IS THE RFA GOING RESTRICT TO THIS SMALL DESIGN TO ADDRESS THE QUESTIONS OR GIVEN FLEXIBILITY BECAUSE OF THE HETEROGENEITY BECAUSE OF THE EXPOSURES. THEY MAY REQUIRE LARGER SAMPLES THAN THE SMALL DATA DENSE APPROACHES. I WORRY ABOUT BEING ABLE TO ZEN ANGLE RADIATION THERAPY OR SUPPORT EFFECTS. >> I'LL START WITH THE ANSWER. >> THAT'S ONE WHERE WE'LL TALK TO ADDRESS. AS A FORMER INVESTIGATOR WHERE I WAS ON STUDIES, WE WOULD TYPICALLY HAVE THE FIRST WEEKS OF A RADIATION AND HAD IT HELD ONE WEEK. IT'S NOT THOUGHT THAT'S DISADD HAVE BEEN TAKE OUT BUT IN THE TRIAL FASHION AND THERE'S THE ISSUE OF TISSUE COLLECTION THAT CAN BE DONE IN THE SPRT SPACE I THINK THE DISENTANGLEMENT IS POSSIBLE AND I'M QUITE SURE THE P.I.s WILL BE ABLE TO REACH THAT LEVEL OF SOPHISTICATION. I'M NOT CONCERNED ABOUT IT. WE HAD QUITE A BIT OF DISCUSSION ON THIS POINT WHEN THE SUBCOMMITTEE MET WITH THE NCI. WE WANT THE INVESTIGATORS TO TELL US HOW THEY'LL UNRAVEL THE EFFECTS AND SPECIFICALLY ASSOCIATED AFFECTS OF COMPONENT AND A RESPONSIBLE AWARD NEEDS TO BE ABLE TO DO THAT. >> THAT'S VERY HELPFUL. WE NEED TO BE CLEAR. >> IF THERE ARE ANY OTHER ISSUES THAT ANYBODY FIELD COMPELLED TO BRING UP MAYBE WE SHOULD DO IT IN AN OPEN DISCUSSION AFTER WE PROCEED WITH VOTING I'LL ASK FOR A MOTION. >> I MOTION TO APPROVE. >> SECOND. >> DISCUSSION? OKAY. ANYBODY VOTING TO DISAPPROVE? DEFER? AB SENSES? -- ABSTENTION. >> OKAY, THE THIRD CONCEPT BEFORE THE QUICK BREAK IS AN RFA CALLED THE GLOBAL CLINIC TRIALS NETWORK TO IMPROVE SCREENING AND PREVENTATIVE THERAPY OUTCOMES FOR CERVICAL CANCER WITH WOMEN LIVING WITH HIV. I WON'T TRY TO PRONOUNCE THE LAST NAME OF THE PRESENTER. THE SUBCOMMITTEE MEMBERS ARE CAROL AND SHERYL AND IAN. >> I'M HAPPY TO PRESENT THIS FOR AN RFA ON COMBLBL CLINICAL TRIALS NETWORK FOR PREVENTIVE THERAPY OUTCOMES FOR CERVICAL CANCER FOR WOMEN LIVING WITH HIV. THIS ADDRESSES TWO EPIDEMICS OF HIV/AIDS AND CERVICAL CANCER AND THE BURDEN IS SIGNIFICANT ESPECIALLY LOW AND MIDDLE INCOME COUNTRIES AND ACROSS THE U.S. IN REGIONS WITH SIGNIFICANT HEALTH CARE DISPARITIES. HIV S THE SIGNIFICANCE OF HIV RELATED CANCER. AS A RESULT OF MASSIVE GLOBAL IMMOBILIZATION AND MILLIONS LIVING WITH HIV ARE ACCEPTING RET RETROVIRAL THERAPY AND LIVING LONGER LIVES BUT UNSETTLING AS CLINICIANS AND RESEARCHERS THAT REMEMBER HIV REMAINS AT RISK OF DYING FROM CERVICAL CANCER IN THE ABSENCE OF CERVICAL CANCER THERAPIES AND BUILDING EVIDENCE THAT CAN SAVE LIVES. IT SEEKS TO ADDRESS THE IMPACT OF RACIAL AND ETHNIC DISPARITIES WHICH EYE PROMINENT FEATURE INFLUENCING THE BURDEN OF HIV AIDS AND CERVICAL CANCER HERE AND IN THE UNITED STATES. THERE'S TWO KEY DEVELOPMENTS UNDER THE DEVELOPMENT OF THE CASCADE INITIATIVE. THERE'S BEEN SIGNIFICANT OBSERVATION IN THE MOVEMENT TOWARDS REGULATORY APPROVAL OF CATALYTIC TECHNOLOGIES FOR PRE CANCER TREATMENT AND SAMPLING AND DIAGNOSTIC APPROACHES AND SECOND TRIP THERE'S BEEN A RENEWED EMPHASIS ON BILATERAL AND MULTI LATERAL CERVICAL CANCER TREATMENT GLOBALLY. THE PRESIDENT'S EMERGENCY PLAN FOR PEP FAR PROGRAMS IS EXPANSIONING DELIVERY TO THE HIGHEST BURDEN REGIONS ESPECIALLY IN SUB-SAHARAN INFRASTRUCTURE IN ADDITION THE WHO RECENTLY LAUNCHED A GLOBAL INITIATIVE TO ELIMINATE GLOBAL HEALTH CANCER AS A GLOBAL HEALTH PROBLEM. AND THAT'S A GOAL TO OPTIMIZE THE CERVICAL CANCER CASCADE FOR WOMEN LIVING WITH HIV. THE PROPOSED CLINICAL TRIALS NETWORK WILL FOCUS ON I78 PROVING THE TREATMENT ACCESS AND OPTIMIZATION OF PRECANCER TREATMENT. THERE ARE SEFRL OUTSTANDING QUESTIONS IN EACH OF THESE AREAS THAT ARE FOCUSSED ON CLINICAL ELEMENT AND OPERATIONAL ASPECTS AND COMPARATIVE EFFECTIVENESS. THE CASCADE NETWORK WILL CONDUCT PHASE 4 CLINICAL TRIALS WITH EFFECTIVENESS AND DESIGNS FOR COUNTRIES AND IN AREAS OF HIGH DISEASE BURDEN AND HEALTH CARE DISPARITIES WITHIN THE U.S. THE TRIALS WILL EVALUATE THE EFFECTIVENESS OF THE VACCINATIONS AND MEASUREMENT OF OUTCOMES INCLUDING INFECTION RATES AND GO CURL INFORMATION SUCH AS COSTS AND TO INFORM SCALE UP OF INTERVENTIONS. A RANDOMIZED TRIAL IN THE NETWORK COULD EVALUATE THE EFFECTIVENESS FOR MANAGEMENT OF HIV AND COMPARING A STRATEGY OF ABLATIVE TREATMENT AND A STRATEGY THAT REQUIRES TRIAGE WITH MOLECULAR BIOMARKERS OR VISUAL APPROACHES BEFORE THE ABLATION TREATMENT FOR THE PERIOD TO BE MEASURED OF THE PRIMARY OUTCOME OF THE TRIAL AND OUTCOMES GIVEN THE PROPORTIONS OF WOMEN ELIGIBLE FOR TREATMENT AND STUDY VISITS BETWEEN THE TWO GROUPS IT SEEMS TO TAKE MEASURES FOR TREATMENT SHOULD THE TREATMENT ON CERVICAL CANCER PREVENTION SUPPORTED BY THE NCI AS SHOWN IN THE SLIDE WILL FILL A RESEARCH GAP AND INITIATIVES IN THE AREA OF CERVICAL CANCER PREVENTION SHOWN IN THE SLIDE WHICH DON'T HAVE AN EXCLUSIVE HIV FOCUS. THE CLINICAL TRIALS WILL TRANSLATE APPROACHES INTO EVIDENCE TO INFORM POLICY AND PRACTICE CHANGE BOTH IN THE UNITED STATES AND IN INTERNATIONALLY. AND IN THIS INITIATIVE FORMING STRATEGIC FORMATION AND PRACTICES ACROSS THE INSTITUTIONAL PORTFOLIO AND FACILITATE INTERACTION WITH OTHER FUNDING AGENCIES FOR SEAMLESS PARTNERSHIPS AND NON-DUPLICATIVE EFFORTS. THE CASCADE NETWORK IS EXPECTED TO CONDUCT SIX TO EIGHT MULTI SITE TRIALS WITH A BASIS OF SELF-ORGANIZED CONSORTIUMS OF INVESTIGATORS TO PROVIDE THE SCIENTIFIC LEADERSHIP FOR THE TRIALS AND THE CLINICAL SITES IN LOW INCOME COUNTRIES AND THE U.S. PROVIDING INFRASTRUCTURE FOR THE PROTOCOLS AND DATA MANAGEMENT SUPPORT AND AUDITING OF THE TRIALS AND NCI WILL HAVE APPROVAL AND OVERSIGHT TO AN OVERSIGHT COMMITTEE. FUNDING IS PROPOSED TO SET ASIDE NCI FUNDS CONGRESSIONALLY MANDATED FOR HIV RESEARCH AND HAS BEEN APPROVED BY THE OFFICE OF AIDS FOR ALIGNMENT WITH THE AIDS RESEARCH PRIORITIES. IT HAS A NETWORK COORDINATING CENTER TO THE MECHANISM AND $1.5 MILLION TO FUND TWO OR THREE RESEARCH FOR AND AN EXPECTATION TWO OF THREE CLINIC SITES WILL BE IN THE UNITED STATES. AND WE REVIEWED THE CONCEPT AND PROVIDED EXCELLENT FEEDBACK. THESE ARE SOME OF THE QUESTIONS WE PROVIDED AND FIRST THIS INITIATIVE WILL BE OPEN TO ONGOING PARTNERSHIP AND DEVELOP NEW PARTNERSHIPS ACROSS THE RANGE OF HEALTH CARE SETTINGS. SECONDLY, THE REVIEW CRITERIA WILL EMPHASIZE THE IMPORTANCE OF LEVERAGING EXISTING INVESTMENTS AND GLOBALLY AND IN THE U.S. AND THE AREA OF SCIENTIFIC FOCUS MAY EVOLVE AND ONCE THE NETWORK IS FUNDED THE ORGANIZATIONAL STRUCTURE AND PROTOCOL DEVELOPMENT PATHWAYS WILL HAVE FLEXIBILITY TO ADAPT AND RESPOND TO OPPORTUNITIES AND CHALLENGES. THE SUBCOMMITTEE ALSO REQUESTED APPROACHES TO ENSURE HIGH QUALITY DATA COLLECTION IN AREAS. WE CLARIFIED THE FUNDS ARE PRIMARILY DESIGNED TO ENSURE EFFICIENCIES IN TRIAL CONDUCT INCLUDING STAFF SUPPORT OR RETENTION AND EFFORTS FOR CLINICAL OF DATA QUALITY AND INTEGRITY. THE REVIEWERS ASKED US HOW WILL THE STUDY SITES WILL BE APPLIED BROADLY AND BEYOND THE CONTEXT OF WELL ORGANIZED HEALTH CARE DELIVERY SETTINGS. WE CLARIFIED WE WILL ENSURE BOTH THE U.S. SITES BEEN THOSE WHO CATER TO PROGRAMS SUCH THAT THE SELECTION OF THE SITES AND FRAGMENTED AND ORGANIZED SETTINGS WILL IMPROVE THE REAL WORLD IMPLEMENTATION OF PRE CANCER TREATMENT SERVICES FOR WOMEN WITH HIV ACROSS THE U.S. AND COMBLOEBLLY. GLOBALLY. >> OVER TO CAROL. >> OUR REVIEW GROUP WAS VERY INTERESTED. THANK YOU. WE WERE ENTHUSIASTIC BECAUSE OF THE FOCUS ON SECONDARY PREVENTION OF CERVICAL CANCER IN WOMEN WITH HIV. AND PRAGMATIC CLINICAL TRIAL AND HAS A GLOBAL REACH AND ALWAYS GOOD THE FUNDING WILL COME FROM MONEY ALREADY ALLOCATED FOR HIV. AND THEY WERE LOGISTIC AND FINANCIAL IN NATURE BECAUSE LOW RESOURCE SETTINGS ARE THE ONES THAT MOST INTERESTED AND MOST STRETCHED IN TERMS OF STAFF AND RESOURCES AND THAT MAKES IT A CHALLENGE TO GET HIGH QUALITY DATA. OUR MAIN CONCERN IS REALLY FOCUSSED ON THE QUESTION IF THERE'S SUFFICIENT FUNDING TO SEE SUCCESS OF THIS INITIATIVE. THERE'S $5 MILLION PER YEAR FOR FIVE YEARS TO FUND TWO TO THREE RESEARCH BASES AND SIX TO EIGHT CLINICAL SITE AND ONE COORDINATING CENTER. AND INTERESTING LOW RESOURCE SETTINGS WOULD BE INCLUDED AND SUCCESSFULLY COMPETE AND PARTICIPATE. WE WERE HOPING ADDITIONAL FUNDS BE CONSIDERED FOR THIS FOR THE LOW RESOURCE SETTINGS BECAUSE THEY KNEAD MORE MONEY TO PROVIDE HIGH QUALITY DATA. THOSE ARE TE ONES WHO HAVE THE MOST CHALLENGE TO BEGIN WITH. WE WANTED TO ENSURE WE WOULD HAVE ADEQUATE RESOURCES. I'M SURE CHERYL AND IAN WOULD LIKE TO ADD THEIR COMMENTS AS WELL. >> MAYBE I'LL ECHO CAROL'S COMMENTS WE WERE ENTHUSIASTIC AND WE DID A SUPERB JOB OF NOT ONLY PRESENTING THIS BUT BEING RESPONSIVE OF OUR BIGGEST CONCERN WAS THIS WAS A PRAGMATIC UNDERTAKING AND THE CONCERN WAS THE FUNDING OR THE MOST CHALLENGING MAY BE CHALLENGING IN AND OF ITSELF. THE DATA MANAGEMENT AND INFRASTRUCTURE THEY HAVE AND ULTIMATELY THE SUCCESS OF THE PROGRAM BASED ON THEIR SUCCESS. OUR GREATEST CONCERN IS THIS A POTENTIAL WHERE WE WANT TO BE ABLE TO BE SURE IT'S GOING TO BE ADEQUATELY RESOURCED. THANK YOU. >> ARE YOU SAYING THIS IS UNDER RESOURCED AND SHUNT GO FORWARD AT -- SHOULDN'T GO FORWARD AT THIS LEVEL BECAUSE THERE'S TWO DIFFERENT THINGS. >> THE LATTER. THE MONEY OKAY AND WE'D LIKE TO SEE IT GO FORWARD BUT MORE MONEY WOULD BE BETTER AND EARMARKED TO FACILITATE THE LOW RESOURCED -- THANK YOU. >> I THINK WE'RE READY TO MOVE TO A VOTE. CAN I CALL FOR A MOTION? >> SO MOVED. >> MOVED TO APPROVE. >> I THINK WE HAD A SECOND. >> ANY DISCUSSION? ANYONE VOTES DISAPPROVAL OR DEFERRAL? ANY ABSTENTIONS? OKAY. I THINK IT'S UNANIMOUS. WITH THAT WE HAVE 28 MINUTE BREAK AND BACK AT 4:00 SHARP >> THE NEXT CONCEPT IS A NEW RFA, NCI CANCER PREVENTION INTEROCEPTION TARGETED AGENT DISCOVERY PROGRAM AND DR. SEI WILL PRESENT. >> THANK YOU. WE'RE PLEASED TO PRESENT OUR NEW PROGRAM AND FIRST FOR THE TERMINOLOGY WE'LL BE USING. THY WORKING DEFINITION OF CANCER CEPTION PREVENTION IS IN THE VIDEO AND FOLLOWING THE INTEROCEPTION IS DEFINED AS DISRUPT OF ON COGENIC PROCESS THROUGH THE INSTITUTE. THE STRATEGIES CAN BE TIERED BASED ON THE LEVEL OF TEST SERVIC SERVICES AND CANCER PREVENTION AND STRATEGY INTENDED FOR EVERYONE TO GO TO I A REDUCED CANCER RISK THROUGH EXAMPLE, SMOKING CRESSATION OR PREVENT -- CESSATION AND ADDITIONAL PREVENTION STRATEGY FOR HIGH RISK COHORT CANNOT BE UNIVERSAL BECAUSE COHORTS INCLUDE INDIVIDUALS WITH DIVERSE RISK FACTORS INCLUDING THE CASE OF DIFFERENT MUTATIONS OR RISING CANCER WITH OR WITHOUT XES AFFECTING MANY ONCOGEN PATHWAY THEREFORE PREVENTIVE STRATEGIES FOR HIGH RISK COHORTS SHOULD BE TAILORED FOR EACH HIGH RISK GROUP AND ALSO REFERRED TO AS PRECISION CANCER PREVENTION DEF INTERCEPTION AND THERE'S LITTLE RISK TAILORED INTERVENTION AND WE'LL ESTABLISH PIPELINE FOR CANCER PRE SENSE AND INTEROCEPTION FOR PASSING ON HIGH RISK INDIVIDUALS WE JUST DISCUSSED. THEREFORE IT'S NOT ABOUT DISCOVERING PREVENTIVE AGENTS FOR THE GENERAL POPULATION OR OR DETERMINING WHETHER CERTAIN THERAPEUTICS CAN BE EFCATION -- EFFICACIOUS AND DOESN'T INCLUDE SCREENING THAT ARE HIGH COST AND WHERE ARE SO LITTLE AVAILABLE BEYOND SURGERY? THERE'S INTERVENTION TARGETS WHICH HAS A ROAD BLOCK FOR HIGH RISK INDIVIDUALS AND INDUSTRIES ARE NOT INTERESTED IN SUCH RESEARCH ENDEAVOR HOWEVER, THERE'S EXPANDING DATA SCIENCE OPPORTUNITIES SUCH AS CHALLENGES FOR EXAMPLE GENOMIC AND MOLECULAR ANALYSIS OF PRE CANCER AND CANCER AND WHEN WE EXAMINE TOGETHER CAN IDENTIFY TARGETS FOR PREVENTIVE INTERVENTIONS. THE PROBLEM IS THERE ARE NO NCI PROGRAMS THAT WOULD FACILITATE WITH THE INNOVATIVE AGENT. WE ARE PROPOSING TO DEVELOP A PIPELINE FOR DISCOVERY TARGETS SPECIFIC AGENTS FOR SPECIFIC CANCER PREVENTION THROUGH VALIDATION OF POTENTIAL TARGETS ALREADY AVAILABLE OR EMERGING THROUGH BIG DATA SCIENCE INITIATIVES ESPECIALLY FOCUSSING ON THE HIGH RISK INDIVIDUALS WE DISCUSSED AND THEN IDENTIFYING AGENTS THAT CAN POTENTIALLY PREVENT OR ELIMINATE BEFORE THEY PROGRESS TO CANCER. NOW, BOTTOM HALF OF THE SLIDE SHOWS THE CURRENT AGENT DEVELOPMENT PIPELINE PREVENT ALSO KNOWN AS PREVENT PROGRAM WAS LAUNCHED ALMOST 10 YEARS AGO MODELLING AFTER THE NEXT PROGRAM SHOWN ON TOP WITH THE MICHELLE FOR INNOVATIVE CANCER PREVENTIVE AGENT TOWARDS CLINICAL TRIALS. AND RESEARCHERS IN ACADEMIA AND BIO TECH FIRMS BECAUSE THEY'RE FUNDED THROUGH RO1 AND OTHER GRANT MECHANISMS NOT ALL THE AGENTS ARE READY FOR LATE STAGE DEVELOPMENT. IT'S NOT PART OF PREVENT OR IS IT A BIG FOCUS OF BIG PHARMA R&D. BY ESTABLISHING MORE STREAMLINED DISCOVERY PIPELINE WE INTEND TO ENGAGE MORE EXTERNAL INVESTIGATORS AND CONVERSELY SCIENTIFIC AND TECHNICAL EXPERTISE TOWARDS THE DISCOVERY OF INNOVATIVE AGENT. THE PIPELINE WILL CONSISTENT OF SCREEN AND SELECTION PROCESSES AND THE PROJECT CAN START AT ANY POINT DEPENDING ON THE DISCOVERY STAGE. AND SUPPORT DEVELOPMENT THROUGH ENABLING STUDIES. ANY NEW INVENTIONS BY INVESTIGATORS WILL BE RETAINED BY THE ORIGINAL INVENTORS. WHAT KIND OF AGENTS DO WE EXPECT TO BE DISCOVERED THROUGH THE PROGRAM? THIS SHOWS ONE TARGETING ONCOGENIC PATHWAYS AND BASAL SELF SYNDROME IS A DOMINANT SYNDROME CAUSED BY GERM LINE MUTATIONS IN THE TUMOR. AFFECTED INDIVIDUALS DEVELOP THOUSANDS OF CARCINOMAS AND AT INCREASED RISK OF DEVELOPING VARIOUS CANCERS DUE TO SIGNALLING PATHWAY. SMALL MOLECULE INHIBITERS HAVE BEEN SHOWN TO EFFECTIVELY BLOCK THE HEDGEHOG PATHWAY. IN FACT IN THE RANDOMIZED PLACEBO CONTROLLED TRIAL NEARLY ALL HAS BEEN SHOWN TO NOT ONLY REDUCE TUMOR BURDEN AND PRESENT BASAL CELL CARCINOMA GROWTH SEEN BY THE BASELINE ON TOP AND BOTTOM. DUE TO THE SYSTEM SIDE EFFECT, THE FORMULATION WAS DEVELOPED AND TESTED IN PATIENTS IN PHASE 2 TRIAL THAT SHOW THE EFFICACY BASED ON THE PHASE 2 STUDY DATA, FDA GRANTED THE DESIGNATION FOR THIS AGENT IN TO 17 AND HAS COME TO PHASE 3 TRIAL. THIS IS THE KIND OF SPECIFIC AGENTS INVESTIGATORS WILL HOPEFULLY DISCOVER THROUGH THE PROGRAM. THROUGH THIS RFA WE ARE PROPOSING TO ESTABLISH UP TO FOUR CENTERS TO UNDERTAKE MULTI P.I. LED AND INTEGRATED STREAMLINE PROJECTS FOCUSSING ON HIGH RISK COHORTS. EACH SPECIALIZED CENTER WILL HAVE CAPABILITIES FOR TARGET VALIDATION, AGENT DISCOVERY AND EFFICACY TESTING. THE CAPABILITIES WILL BE MOBILIZED IN THE FLEXIBLE MODEL MADE ON NEEDS AND PROGRESS MADE AND WE ARE PROPOSING TO ESTABLISH ONE DATA AND RESOURCE COORDINATION CENTER WHICH WILL ESTABLISH A DATABASE AND PROVIDE FOR MANAGEMENT SUPPORT TO ENHANCE NETWORK SYNERGY. I'LL SKIP THIS SLIDE IN THE INTEREST OF TIME BUT EXCEPT TO NOTE OUR PORTFOLIO ANALYSIS HAS IDENTIFIED MORE PROJECTS FOCUSSED ON UNDERTAKING ALL THE RESEARCH OBJECTIVES. THE SLIDE SHOWS A PROPOSED BUDGET FOR FIVE YEARS STARTING IN FY22. WITH THE BUDGET WE EXPECT EACH CENTER TO CARRY OUT THE TO FOUR TO FIVE SUBJECTS IN FIVE YEARS AND CONTINUE THE OPPORTUNITIES WE HAVE DISCUSSED AND SET ASIDE TO SUPPORT ADMINISTRATIVE SUPPLEMENTS FOR NEW COLLABORATION OPPORTUNITIES ESPECIALLY WITH INVESTIGATORS. JUSTIFICATION FOR THE RFA INCLUDES A HIGH DEGREE OF SCIENTIFIC AND TECHNOLOGY COORDINATION EXPECTED TO BE REQUIRED. SET ASIDE FUNDING WILL ALSO ENSURE SUPPORT FOR INNOVATIVE RESEARCH PROJECT WITHOUT DISRUPTION AND THE AGREEMENT MECHANISM IS ALSO NECESSARY BECAUSE WE ANTICIPATE SPECIAL PROGRAMMATIC INVOLVEMENT AND ALLOW FLEXIBILITY AND COORDINATION. AND LASTLY, WE ARE VERY GRATEFUL TO BE REVIEWERS WHO PROVIDED HELPFUL COMMENTS AND SUGGESTION AND ADVICE AND THE SLIDE SUMMARIZES THE CLARIFICATION TO THE COMMENTS. I CAN STOP HERE AND YIELD TO THE CLIFF AND REVIEWS -- TO THE CHAIR AND REVIEWERS FOR COMMENT AND QUESTIONS IN THE INTEREST OF TIME. THANK YOU FOR YOUR ATTENTION. >> THANK YOU. KAREN. >> THANK YOU FOR THE CLEAR PRESENTATION. I THINK AS YOU SEE THIS IS AN ACCURATE REFLECTION OF THE COMMENTS OF MYSELF AND OVERALL WE HAD HIGH ENTHUSIASM AS A REVIEWER GROUP FOR THE INNOVATIVE APPROACH THAT THIS PROPOSAL IS TAKING TOWARD THE OVERALL GOAL. WHERE WE FELT VERY PASSIONATELY WHAT WAS ABOUT THE FLEXIBILITY POINT -- ARE YOU HEARING ECHOS OR IS THAT JUST ME? >> THERE IS SOME ECHO. CAN EVERYBODY MUTE? WITH WE HAD SIGNIFICANT INTEREST IN PROJECT ENTRY POINTS FOR EXAMPLE THERE COULD BE PRIORITIZATION FOR PROJECTS THAT HAD ALREADY GONE THROUGH THE TARGET VALIDATION STEP. MANY OF OUR COMMENTS WERE DRIVEN TOWARDS TRYING TO INCREASE THE PACE OF DISCOVERY AS MUCH AS HUMANLY POSSIBLE. WE ALSO TALKED ABOUT THE OVERALL MECHANISM OF THE U54 VERSUS AN RO1 MECHANISM FOR THIS TYPE OF INITIATIVE AND THERE WAS ADDITIONAL REFINEMENT OF THE PROPOSAL AS YOU SAW TO OFFER SUPPLEMENTS AND ALLOW OTHERS TO ENTER INTO IN THE POOL. WE SAW THE VALUE OF SUCH A PROGRAM AND IT'S CREATIVE AND INNOVATIVE AND I'LL ASK IF THERE'S ANYTHING I'VE MISSED. >> I DON'T HAVE MUCH TO ADD. ONE THING THAT COMES UP OFTEN IS THESE ARE TARGETS WE SEE AND CAN BE USED FOR ESTABLISHED CANCERS AND THE ANSWER IS NO THESE ARE DIFFERENT. AND AFTER BEING IN THE PREVENTION FIELD A LONG TIME WE'LL BE IN THE SAME FORMULATION. THERE'S A NEED TO GET MODEST PROGRAM AND OVERALL I THINK EACH CAN ANSWER APPROPRIATELY TO THE COMMENTS. >> VERY MUCH A SUPPORT PROGRAM AND KAREN CAPTURED ALL MY ORIGINAL COMMENTS. >> ANY FURTHER DISCUSSION FROM THE PANEL? >> I THINK AFTERNOON FATIGUE IS SETTLING IN. IF THERE'S NONE, MAYBE I CAN CALL FOR A MENTION. WE'LL ME OF TO VOTING NOW. >> I CAN MAKE A POINT. I THOUGHT IT WAS CLOSE TO THE PANEL. I FOUND IT INTERESTING AND VERY CLEAR THE DISTINCTION BETWEEN CAPID AND EDRN BUT THERE SEEMS TO BE SYNERGIES. I GUESS TO ME THE IDEA OF FIND DIAGNOSTIC MARKER FOR EARLY DETECTION OF CANCER IS REALLY IMPORTANT TO SORT OF TRY TO FIND THREE INVASIVE DISEASE AND THAT'S WHAT YOU'RE TARGETING IN CAPID. CAN YOU COMMENT ON THE CONNECTION MORE WITH EDRN AND MAYBE A NEED TO COORDINATE BECAUSE I THINK SOME DIAGNOSTIC MARKERS MAY ALSO BE THERAPEUTIC TARGETS. >> THANK YOU SO MUCH. IN THE INTEREST OF TIME I COULD NOT SHARE THE SLIDE WITH YOU BUT THAT'S EXACTLY OUR PLAN TO COORDINATE AND COLLABORATE WITH EDRN AND TURN TO A T BELL. THERE ARE MANY PROGRAMS WE'D LIKE TO WORK WITH TO PRIORITIZE TARGET AND THE DIFFERENCE BETWEEN EDRN AND CAPID IS AGE IN ENT DISCOVERY PART. IT'S LIKE MAKING A BRIDGE TO EDRN WHERE WE'LL BE CONSTANTLY WORKING WITH THEM TO REALLY PRIORITIZE AND MAY SERVE AS OUR TARGETS FOR TUMOR INTEROCEPTION. THAT'S WHAT WE HAVE BEEN DISCUSSING OVER THE DIVISION. WE ALSO PLAN TO APPROACH OTHER PROGRAMS ONCE THE PROGRAM IS ESTABLISHED. THANK YOU FOR BRINGING THAT UP AND I APOLOGIZE FOR MISSING THAT SLIDE TODAY. >> THANK YOU FOR THE CLARIFICATION. VERY IMPORTANT. SO PERHAPS WE CAN MOVE NOW TO THE VOTING PART OF THE PRESENTATION. I WOULD LIKE IT CALL FOR A MOTION. >> MOTION TO APPROVE. >> SECOND. >> SECOND. >> ANY DISCUSSION? >> ANYBODY VOTING TO DISAPPROVE? ARE THERE ANY ABSTENTIONS? OKAY. I THINK WE ARE GOOD TO GO FOR UNANIMOUS APPROVAL. >> CONGRATULATIONS. OUR LAST CONCEPT IS A NEW CLINICIAN SCIENTIST RESEARCH AWARD CSRA. DIM -- JIM DOROW SHOW AND THE REVIEWERS ARE HERE. >> THANK YOU. THANK YOU IT'S A REAL PLEASURE TO PRESENT THE NEW CONCEPT FOR A CLINICIAN SCIENTIST R50 CONCEPT. I DON'T THINK I HAVE TO WORK VERY HARD TO CONVINCE THE MEMBERS OF THIS GROUP THAT INVESTIGATORS OF ACADEMIC INSTITUTIONS ARE VITAL TO THE MISSION OF THE NCI AND THOSE INCLUDE DEVELOPING NEW TRIALS AND DEFINING LEADERSHIP FOR THE INFRASTRUCTURE AND CANCER CENTERS AND OTHER INSTITUTIONS AND ALSO A FACT THAT CLINICAL DUTIES AND REQUIREMENTS TO GENERATE CLINICAL REVENUE MAKE IT DIFFICULT FOR CLINICIAN INVESTIGATORS TO SPEND THE TIME THEY NEED TO PEND TO DO ALL THE THINGS ESSENTIAL TO MOVING THE CLINICAL TRIALS PROCESS FORWARD. THE NCI IS VERY INTERESTED IN ENCOURAGING A CAREER PATH IN ACADEMIA THAT PROVIDES TABLE FUNDING FOR THE INDIVIDUALS VITAL TO MAINTAINING THE MISSION AT NCI NAMELY CLINICAL TRIALS IN AN INVESTIGATIONAL SETTING. SO WHAT'S THE PURPOSE OF THE AWARD? TO PROVIDE STABLE SALARIES FOR OUTSTANDING CLINICIAN SCIENTIST WHO'S WANT TO FOCUS ON CONDUCTING NCI CLINICAL TRIALS BUT NOT SEEKING THEIR OWN INDEPENDENT RESEARCH FUNDING. SO WHAT ABOUT OUR PORTFOLIO? THIS IS A SLIDE THAT TAKES VERY LITTLE TIME TO REVIEW BECAUSE THERE ARE NO CURRENT MECHANISM TO SUPPLY SUSTAINED SALARY SUPPORT FOR INVEST INVESTIGATORS AND SOMETIMES THEY PROVIDE SHORT TERM SUPPORT AND PEM -- PEOPLE ARE AWARDED AND THEY'RE NOT STABLE ONGOING SUPPORT FOR INVESTIGATOR AND WE HAVE THE ESTABLISHED RESEARCH SPECIALTY AWARDS FOR CORE LABORATORY SCIENTISTS WHO PROVIDE ESSENTIAL SUPPORT TO INDIVIDUALS WHO HOLD RO1 GRANTS OR CANCER CENTERS. THIS IS A PROGRAM THAT WAS A DIRECT OUTCOME OF THE CLINICAL TRIAL WORKING GROUP RECOMMENDATIONS AND PROVIDES RECOGNITION AND LIMITED SUPPORT FOR MID-LEVEL OR EARLIER LEVEL CLINICAL LEVEL INVESTIGATORS FOR INDIVIDUALS HELPING TO SUPPORT PROGRAMS AND CONDUCTING NCI FUNDED RESEARCH. THEY'RE ADMINISTRATIVE SUPPLEMENT TO B PO GRANTS. THEY'RE -- B30 GRANTS AND FOR $60,000 A YEAR FOR TWO YEARS AND IT'S BEEN A SUCCESSFUL PROGRAM AND 90% ARE STILL IN ACADEMIC RESEARCH POSITIONS FOR EARLY STAGE INVESTIGATORS AND FOR MONIES NON-RENEWABLE. WE'RE TALKING ABOUT TRYING TO PROVIDE FUNDING FOR EARLY MID LEVEL ASSOCIATE PROFESSORS WHO HAS PROVEN HIMSELF OR HERSELF TO BE ESSENTIAL TO THE CLINICAL TRIALS ENTERPRISING OR ACADEMIC INSTITUTION. WE'RE LOOKING TO SUPPORT CLINICIAN SCIENTIST WHO'S HAVE CLINICAL DEGREES PRACTICING IN AN ONCOLOGY CENTER OR Ph.D. DEGREES IN CLINICAL DISCIPLINES WITH DIRECT PATIENT CONDUCT AND INDIVIDUALS NOT THE EYES OF RO1 AS OR PO1s AND CAN HAVE A SMALL GRANT LIKE AN R03 OR CAN HAVE SOME FUNDING FROM THE NCTN OR FROM CAREER DEVELOPMENT AWARDS OR P30. AND NOTE THE PAST FUNDING ON THE SMALLER AWARDS WILL NOT AFFECT ELIGIBILITY. WE'RE LOOKING TO PROVIDE UP TO 40% CALORIE SUPPORT AND 40% EFFORT WITH THE INDIVIDUALS THROUGH THE RR50 AND HAVE FUNDING AT 50%. SOMEONE MAY BE THE P.I. FOR A CLINICAL TRIAL NOTE THE P.I. OF A PROGRAM PROJ THAT MAY GIVE THEM 5% TO 10% FUNDING AND THAT WOULD BE FINE. THIS WOULD REQUIRE SUPPORT FROM THE INSTITUTION AND LETTERS OF RECOMMENDATION AND THE INDIVIDUALS NEED TO BE CONDUCTING NCI FUNDED CLINICAL TRIALS AND NEED TO HAVE PARTICIPATED IN THE INFRASTRUCTURE IN THE INSTITUTION'S CLINICAL TRIALS AND ANY ACADEMIC INSTITUTION CONDUCTING NCI SUPPORTED TRIALS WOULD BE ABLE TO NOMINATE SOMEONE FOR THIS AWARD. SO HOW WILL WE EVALUATE THIS ACTIVITY? AND THE INDIVIDUALS THAT APPLY? WE'RE TALKING ABOUT THEIR ABILITY TO ACCRUE THE NCI CLINICAL TRIALS AND THE ABILITY TO DEVELOP NATIONAL TRIALS AND PROVIDE LEADERSHIP IN THE CLINICAL TRIALS NETWORKS PARTICIPATING IN OUR STEERING COMMITTEE AND AS SITE INVESTIGATORS OR NCI NETWORKS. AND THEY'RE INDIVIDUALS AND YOU KNOW WHO THESE FOLKS ARE WHO PROVIDE ESSENTIAL GLUE TO THE INSTITUTION'S CLINICAL TRIALS RESEARCH STRUCTURE WHETHER IT'S WORKING OR SUPERVISING IN THE IRB, PROTOCOL REVIEW AND MONITORING SYSTEM AND SAFETY MONITORING COMMITTEES. THEY'RE ESSENTIAL COMMITTEES RARELY ARE THERE PEER-REVIEWED SUPPORT AND YET THEY'RE ESSENTIAL. AND WE'RE LOOKING FOR INDIVIDUALS WHO PLAY' ROLE IN THE MODALITY BASED GROUPS WHICH ARE PRESENT AT ALL OF OUR CANCER CENTERS AND PARTICULARLY INTERESTED WHETHER THESE INDIVIDUALS HELP TO ENSURE THE INCLUSION OF UNDER SERVED POPULATIONS IN THE INSTITUTION'S CLINICAL TRIALS. SO WHAT'S THE BUDGET? WE'RE LOOKING TO SPEND ABOUT $3 MILLION A YEAR TOTAL COST TO SUPPORT 26 SUCH AWARDS AND ANTICIPATE BASED ON THE OTHER R50 GRANT TO HAVE FEWER APPLICATIONS GOING FORWARD AND MY GUESS IS WE'RE LIKELY TO HAVE A LARGE NUMBER OF APPLICATIONS FOR THIS ACTIVITY WHICH IS SO MUCH NOT SOMETHING THE NCI HAS SUPPORTED IN AN SIGNIFICANT LEVEL. WE'RE GOING EVALUATE THE PROGRAM THROUGH THE FIRST FIVE YEARS NOT ONLY BY THE STRENGTH OF THE APPLICATIONS OR NUMBER OF APPLICATIONS WE GET IN BUT I THINK WE'LL AND LONG-TERM WE'RE LOOKING TO HELP TO OUR NCI CLINICAL TRIALS AND SUPPORT THE LEADERSHIP AS PARTICIPANTS IN OUR NETWORKS. WE THINK THIS IS SOMETHING THAT NEEDS TO BE TESTED. WE HAVE AN EXCELLENT CONVERSATION WITH OUR SUBCOMMITTEE WE'RE LOOKING THAT SCIENTIST WHO'S PARTICIPATE AND FUNDED IN THIS FASHION CAN DO PHASE 1 STUDIES AND WORK ON NCTN AND DO CANCER CONTROL BUT THE FULL RANGE OF CLINICAL TRIAL OPPORTUNITIES. WE'RE NOT INTERESTED IN SUPPORTING CLINICIAN SCIENTIST WHO'S FOCUS PRIMARILY ON INDUSTRY TRIALS BUT WHO FOCUS ON THE NCI SYSTEMS AND FOR Ph.D. CLINICIAN SCIENTISTS LOOKING FOR INDIVIDUALS UNDER SUCH DIRECT PATIENT CONDUCT. WE CAPPED THE TOTAL GRANT AWARD TO 50% UP TO 40% IN THE R 50 AND THIS IS A RENEWABLE MECHANISM WE HOPE WILL PROVIDE INDIVIDUALS WITH STABLE SUPPORT. EACH INSTITUTION OR CANCER CENTER WILL BE LIMITED TO ONE APPLICATION IN A CALENDAR YEAR AND PUT IN TO THE LANGUAGE TO IMPROVE THE DIVERSITY OF THE WORKFORCE IN THE FUNDING ANNOUNCEMENT. I'D LIKE TO GIVE MY APPRECIATION TO MY COLLEAGUES IN THE OFFICE OF CANCER CENTERS AND CENTER FOR CLINICAL TRIALS AND DIVISION OF CANCER PREVENTION. ALL INDIVIDUALS PLAYED AN IMPORTANT ROLE IN DEVELOPING THIS CONCEPT AND IT WOULD NOT HAVE BEEN DEVELOPED WITHOUT THEIR HELP. HAPPY TO TAKE QUESTIONS. >> THANK YOU, JIM. KEVIN, YOU DO YOU WANT TO TAKE IT AWAY? >> THAT WAS A GREAT PRESENTATION AND CLEAR AND CRISP AND SUMMARIZED THE KEY POINTS AND EXCELLENT CONVERSATION IN TRYING TO WORK THROUGH SOME OF THESE QUESTIONS AND ISSUES WE DID EXPRESS SOME CONCERN IT WOULD BE SUB POPULAR BECAUSE IT'S FILLING SUCH A NEED AND WE'LL SEE HOW IT GOES. WE THOUGHT THE BUDGET WAS MODEST AND WELL JUSTIFIED. THERE WERE A FEW AREAS THAT CAME UP. THERE WERE MULTIPLE INSTITUTIONS UNDER A SINGLE NCI CANCER CENTER. WE CAN ENCOURAGE THE NCI TO RESTRICT THAT TO A SINGLE APPLICANT. AND WE TRY TO MAKE IT AVAILABLE BROADLY AROUND THE COUNTRY. WE CAME AROUND TO THE IDEA THAT IT WAS A GOOD IDEA WE LEVERAGED THE EXPERTISE AND ALSO CAME UP WITH THE CAP YOU DESCRIBED AS SOMEBODY IS GETTING 20% OR 25% OF THE EFFORT AND CONDUCTING CLINICAL TRIALS THROUGH A COLLABORATIVE GROUP THE R50 HAS BEEN SUCCESSFUL AND COPIED BY OTHER INSTITUTES. WE HAD AN INTERESTING CONVERSATION AND MAYBE OPENED A PANDORA'S BOX IS WHETHER THERE'S THOUGHT DOWN THE ROAD FOR THE NCI WITH A PARTNER AWARD FOR THIS WHICH WOULD BE AN R51 CLINICIAN SCIENTISTS AWARD. MODELLED ON THE F31 MODEL AND THE R51 WOULD BE FOR CLINICAL INVESTIGATORS FROM UNDER REPRESENTED MINORITY GROUPS GIVEN THE CHALLENGES IN TRYING TO FIRST OF DEVELOP A CADRE OF INVESTIGATORS AND LEADERS FROM UNDER REPRESENTED GROIPZ AND THE ABILITY -- GROUPS AND THEIR ABILITY TO SPEAK IT THOSE UNDER REPRESENTED IN CANCER CLINICAL TRIALS. THOSE WERE THE OTHER AREA WE HAD A LIVELY CONVERSATION ABOUT AND KIM IS IN CLINIC SEEING PATIENTS AND MAYBE I'LL TURN IT OVER TO OTIS. >> WIT AS A GREAT CONVERSATIONS AND WE HAD CONCERNS PUT ON A SLIDE THERE. I FULLY ENDORSE THE CONCEPT. >> I HAD A QUESTION IN TERMS OF INSTITUTIONAL ACCOUNTABILITY BECAUSE A LOT OF THE SUCCESS DEPENDS ON HOW THE INSTITUTION PRIORITIZED THE ROLE OF THIS PARTICULAR INVESTIGATOR. IS THAT PART OF THE MECHANISM? IS THERE A COMPONENT WHERE YOU GET THE BUY IN OF THE INSTITUTION? >> THERE HAS TO BE A NOMINATION. >> OKAY. BUT IS THERE ANYTHING OTHER THAN THE INSTITUTION SUGGESTING THIS INDIVIDUAL IS QUALIFIED OTHER THAN THAT DOES THERE HAVE TO BE ANY OTHER THINGS THAT LIDFIES THE PARTNERSHIP? AND THERE'S A BULLET THAT SAYS CLEARLY THESE AWARDS ARE NOT FOR INDIVIDUALS PRIMARILY PURSUING FULLY PHARMACEUTICAL SPONSORED TRIALS. AND THESE INDIVIDUALS ARE GOING TO GET UP TO 40% SUPPORT TO DO NCI AND NETWORK BASED TRIALS OR INVESTIGATOR INITIATED CANCER TRIALS FOT TRIALS THAT GENERATE ENORMOUS AMOUNTS OF REVENUE. INTEREST WOULD REQUIRE INSTITUTIONAL COMMITMENT. >> Ph.D.s CAN ALSO BE QUALIFIED AND THIS IS AN AREA WHERE WE CAN DO BETTER BECAUSE THERE'S A SIGNIFICANT NUMBER OF Ph.D.s NOW GRAVITATING TOWARDS THIS PARTICULAR AREA. YOU SID THE ONLY REQUIREMENT IS THE Ph.D. IS DOING WORK THAT INVOLVES CONTACT OR WAS THAT -- THAT'S THE ONLY THING THAT IS REQUIRED FOR THIS? >> MANY MANY EXAMPLES AND SEVERAL FOLKS ON THIS CALL REPRESENT THOSE AND CLINICAL PSYCHOLOGISTS DOING QUALITIES OF LIFE ARE APPROPRIATE AND A NURSE OR MANY INDIVIDUALS ONLY NEED AN M.D. DEGREE. >> AND CLINICAL SCIENTISTS MUST HAVE SOME SORT OF CLINICAL CONTACT AND YOU HAVE THE ENTIRE SCOPE OF CLINICAL TRIALS. >> IF THERE'S CONTACT I THINK IT WILL BE VERY APPROPRIATE. >> SO CLINICAL CONTACT MAY LIMIT THAT SO BE CLEAR OF THE WORDING BEING CLEAR THAT WORKING WITH PATIENTS IS APPLICABLE AS WELL. >> THE DISCUSSION WE HAD WITH OTIS AND KEVIN AND KIM THE EXAMPLE AND I WANT TO SAY SOME OF MY BEST FRIENDS ARE STATISTICIANS IT'S NOT AN AWARD FOR STATISTICIANS. >> THANK YOU. I SEE SOME CANCER CENTER DIRECTORS. >> A QUICK QUESTION. UNLESS I MISSED IT SOUNDS LIKE YOU'RE FIRST STAGE IN THIS AWARD AND THE THOUGHT IS THEY'LL CHOOSE FOR YOU WHETHER THEY WANT PEOPLE YOUNGISH BUT WHEN YOU DESCRIBE SOMEONE WHO IS SPENDING MOST OF THEIR TIME OR 40% OF THEIR TIME DOING NCI WORK, THAT'S GOING TO SELF-DETERMINE THE COOL AND SLANT TOWARDS AT LEAST MID CAREER THAT CONSUMES SACH OF THE TIME. I'M RAISING THAT BECAUSE I WANT TO GET YOUR THOUGHTS ON THIS AS A RETENTION EFFORT FOR THOSE PEOPLE. AND MANY HAVE REVENUE TO SUPPORT SALARIES WHERE YOUNG MID CAREER INVESTIGATORS ARE PRONE TO BE LOST. >> MOVE THE CTLA FIRST WE'RE TO TAKE PEOPLE JUST COMING ON FOURTH OR FIFTH YEAR FELLOWS GET THEIR FIRST TWO YEARS OF SUPPORT FROM THE CANCER CENTER AND HELP THEM ALONG I SEE THIS FOR ANYBODY THERE LATE ON AND I WAS A P.I. WITH CCSG. THE CCSG P.I. SAYS GEE, DON'T YOU WANT TO BE HEAD OF THE PROTOCOL REVIEW AND COMMITTEE. I CAN'T OFFER YOU MONEY BUT IT'S IMPORTANT. WE HAVE TO DO THIS. IT'S NOT JUST FOR PEOPLE WHO HAVE TRIALS BUT SUPPORT CRITICAL INFRASTRUCTURE WHO IF YOU DON'T HAVE A BIG RO1 PORTFOLIO, WELL, YOU KNOW WHAT I MEAN. >> THIS PHRASE NCI FUNDED TRIAL I HEARD IT A FEW DIFFERENT WAYS IN THE LAST 10, 15 MINUTES. >> IT WOULD BE A TRIAL THAT IS FUNDED ON THE PERSON THAT IS THE SBOR P.I. OR FROM PHILANTHROPIC DOLLARS BUT JUST NOT A PHARMA TRIAL. >> AND IF YOU HAVE A PHARMA SPONSORED TRIES TO AND A RO1 TO PAY FOR A HYBRID IS THAT TOO MUCH IN THE WEEDS? >> NO, BUT IF YOU HAVE AN RO1 YOU'RE NOT ELIGIBLE. THESE ARE FOR FOLKS WHO ARE NOT GOING TO GET AN RO1. >> I LIKE THIS CONCEPT. >> THIS WILL RESULT IN AKUGE MORE TRIALS AND ALL KINDS OF TRIALS ARE GREAT. I THINK IT WILL HAVE TO BE WATCHED VERY CAREFULLY THOUGH BECAUSE THE PRESSURES AT THE INSTITUTIONS ARE EVEN FOR THE CLINICIAN RESEARCH TO DO INDUSTRY TRIALS BECAUSE THEY BRING IN [INDISCERNIBLE] ETCETERA. WE HAVE FOLKS WHO HAVE EFFORT DOING CLINICAL TRIALS FROM TO THE SPORES. WE HAVE TO KEEP REMINDING THEM THEY THEY'RE DOING THE CLINICAL RESEARCH TRIALS BECAUSE THERE'S CLINICAL PURPOSES FOR THE ARTICLES IN MY OPINION TO ALLOW THEM TO BECOME CLINICAL TRIALS. I THINK IT'S WONDERFUL BUT THE CONCEPT OF TIME EVEN FOR SENIOR PEOPLE PROTECTS TIME TO DO THE CLINICAL RESEARCH AND ACCRUE TE PATIENTS THAT'S THE STRENGTH OF THE PROGRAM. >> I THINK GIVEN THE WE'RE ONE MINUTE OVER UNLESS THERE'S USH GENT ISSUES ANYBODY WANTS TO RAISE I SUGGEST WE MOVE TO VOTING. >> MOVE TO APPROVE. >> ANY DISCUSSION, ADDITIONAL DISCUSSION? OKAY. HOW MANY DISAPPROVE FOR DEFER >> GREAT, UNANIMOUSLY APPROVED. GREAT HAVING YOU ALL AND GREAT SESSION AND WE'LL SEE YOU ALL TOMORROW.