>>TODAY IS THE SECOND DAY OF OUR COUNCIL MEETING AND TODAY IS LARGELY DEVOTED TO CONCEPT CLEARANCES BUT BEFORE WE GET STARTED, WE NEED TO DO A ROLL CALL AGAIN. SO I'M GOING TO GO THROUGH THE MEMBER LIST AND JUST LET ME KNOW IF YOU'RE HERE. SO PLEASE SPEAK UP OR WAVE A HAND. [ ROLL CALL ] I THINK WE ALSO HAVE AD-HOC MEMBERS IN ATTENDANCE TODAY: [ ROLL CALL ] THINK DOES IT. AND I THINK WE ARE GOOD TO GO. ANNA DOES THAT COMPORT WITH YOUR LIST? >> YES, IT DOES. >> OKAY. FANTASTIC. AGAIN, THANK YOU EVERYONE FOR BEING HERE TODAY. AS YOU CAN SEE FOR THE AGENDA TODAY ON DAY 2, WE WILL BE PRIMARILY DEVOTING THIS DAY TO THE CLEARANCE OF A VARIETY OF CONCEPTS. WE HAVE FOR YOU TODAY BUT BEFORE WE GET STARTED ON THE CONCEPTS, I WANT TO MAKE SURE WE GO OVER ANY REMAINING LOGISTICS, ANNA, THAT YOU HAVE. DO YOU WANT TO GIVE US A SHOUT OUT ON THE LOGISTICS AND THEN WE'LL GET BACK TO THE AGENDA AND THE CONCEPTS. >> CERTAINLY. AGAIN TODAY WE ARE HAVING A ZOOM MEETING. EVERYONE IN THE ZOOM MEETING IS A PANELIST SO YOU'RE FREE TO SPEAK. HOWEVER, IN ORDER TO HAVE SOME ORDER TO THE SESSION, WE'D LIKE TO YOU USE THE RAISE HAND OR CHAT FEATURE AND THEN WAIT TO BE CALLED UPON TO PROVIDE INPUT. [ READING ] WITH THAT, I'D LIKE TO TURN IT OVER TO JONI. >> YES, YOU HAVE A COMMENT, FIRST? >> I HAVE A QUESTION ON THOSE DATES. THE SEPTEMBER MEETING IS TWO DAYS BECAUSE WE ANTICIPATE HALF DAYS BECAUSE OF ZOOM? OR IT WOULD COLLAPSE TO ONE DAY IF IT TURNS OUT TO BE IN PERSON? >> THAT'S GENERALLY HOW IT WOULD WORK. SO RIGHT NOW, WE EXPECT IT TO BE VIRTUAL. WE ARE DOING TWO HALF-DAY ZOOM MEETINGS. UNTIL NIH NOTIFIES US OTHERWISE WE ARE GOING TO PLAN FOR THE VIRTUAL SESSIONS. BUT OTHERWISE IF WE ARE FACE-TO-FACE, WE SHOULD ONLY MEET ONE DAY. >> SECOND QUESTION. THIS PORTION OF THE MEETING IS OPEN TO THE PUBLIC, CORRECT? >> YES. >> AND DO WE HAVE A ROLL CALL OF WHO IS ATTENDING? DO WE KNOW THAT? >> NOT ON THE PUBLIC SIDE. THEY ARE WATCHING BY VIDEOCAST. >> OKAY. THANK YOU. >> TODAY WE WILL CONSIDER 7 CONCEPTS. WE DO HAVE A BREAK SPREAD THROUGHOUT SO THAT SHOULD BE HELPFUL AS WE GO THROUGH THESE CONCEPTS. I'M GOING TO ALSO JUST MENTION THAT CLAIRE WILL BE MODERATING THE DISCUSSION FOR FIRST AND SECOND CONCEPTS AND HELPING TO MODERATE THE OTHER CONCEPTS 3-7. I'LL BE DOING SOMETHING OF THAT AS WELL. FOR EACH CONCEPT, THE PROGRAM OFFICER WILL PRESENT THE CONCEPT AND THEN WILL ASK DISCUSSANTS ASSIGNED TO THAT CONCEPT, AND OTHER MEMBERS TO, COMMENT. AND THEN WE'LL OPEN THE FLOOR FOR ADDITIONAL DISCUSSION AT THAT POINT IN TIME. WE'LL VOTE IMMEDIATELY AFTER EACH OF THE FIRST TWO CONCEPTS BECAUSE THEY ARE NOT LINKED TO ONE ANOTHER. THEY ARE DISTINCT IN AND OF THEMSELVES SO WE ARE GOING TO GO AHEAD AND HOLD THE DISCUSSION AFTER EACH ONE OF THOSE FIRST TWO AND THEN VOTE AFTER EACH ONE. FOR THE REMAINDER OF THE CTSA SUITE OF CONCEPTS BELOW THAT DARK LINE HERE ON THIS TABLE, WE WILL PRESENT ALL FIVE CONCEPTS AND DISCUSS EACH OF THOSE IN TURN. SO WE'LL HAVE AN OPPORTUNITY TO DISCUSS RIGHT AFTER EACH ONE. AND THEN WE ARE GOING TO HOLD OFF ON THE VOTING UNTIL THE END SO THAT YOU CAN SEE THE ENTIRE PACKAGE OF THE SUITE OF THE CTSA CONCEPTS BEFORE VOTING ON ALL OF THEM. THAT'S THE IDEA OF WHY WE ARE DOING IT IN THAT WAY FOR THOSE CTSA CONCEPTS. IN ADDITION, AFTER WE COMPLETE THE CTSA CONCEPT PRESENTATIONS AND DISCUSSION, THERE WAS A LETTER THAT WAS ADDRESSED TO THE COUNCIL MEMBERS AND TO ME THAT I RECEIVED, AND IT IS DIRECTLY RELATED TO THE CTSA PROGRAM CONCEPTS. RECEIPT OF THIS LETTER WILL BE DOCUMENTED IN THE MINUTES FOR THIS COUNCIL MEETING. AND THEN AFTER THE DISCUSSION OF ALL OF THESE CONCEPTS, WE WILL THEN HOLD A VOTE ON EACH OF THE CTSA CONCEPTS INDIVIDUALLY AND ALSO HAVE AN OPPORTUNITY TO DISCUSS THAT AT THAT POINT IN TIME. SO, NOW I THINK I'M GOING TO TURN IT BACK OVER TO ANNA TO INTRODUCE THE CONCEPT PRESENTATIONS AND GO AHEAD AND MOVE FORWARD WITH THAT. SO ANNA, BACK TO YOU. >> THANK YOU, JONI. SO OUR FIRST CONCEPT FOR THE DAY WILL BE TO IDENTIFY DUANE FOR A CONTRACT SUPPORT FOR THE NCATS INTRAMURAL R&D ACTIVITY. TAKE IT AWAY DUANE. >> THANK YOU, ANNA. GOOD AFTERNOON. I'M DUANE, DEPUTY DIRECTOR OF THE THERAPEUTIC DEVELOPMENT BRANCH AND WE SEEK COUNCIL CONCURRENCE FOR THE RENEWAL CONTRACT SUPPORT FOR THE INTRAMURAL R&D ACTIVITIES. FIRST SLIDE, PLEASE. SO FOR BACKGROUND, THE COMPLIMENT IN-HOUSE SCIENTIFIC CAPE BUILT, DBPI SCIENTISTS REQUIRE DEVELOPING SUPPORT SERVICES SUCH AS: [ READING ] THIS CONTRACT MECHANISM IS A KEY COMPONENT OF OUR DAY-TO-DAY ACTIVITIES AND NCATS PROPOSES TO RENEW THIS CONCEPT IN ORDER TO MAINTAIN CONTINUED ACCESS TO OUR MISSION CRITICAL RESEARCH SERVICES. NEXT SLIDE, PLEASE. OBJECTIVES AND AREAS OF EMPHASIS: [ READING ] A COUPLE OF RECENT EXAMPLES INCLUDES A SMALL MOLECULE FOR TREATING SICKLE CELL DISEASE AND BIOLOGICS FOR SPINAL CORD REGENERATION. [ READING ] THIS IS IN A TOTAL OF OUR 40INDs THAT ALL OF OUR PROGRAMS HAVE BEEN A PART OF TO DATE. SO NEXT SLIDE, PLEASE. SO IMPLEMENTATION AND EXPECTED INPUT: [ READING ] JUST TO CLARIFY, A DECK ALLOWS THE GOVERNMENT TO RESTRICT OR ELIMINATE A CONTRACTOR'S RIGHT TO FEDERALLY-FUNDED INVENTIONS OR DATA INCLUDING ANY COLLABORATOR IP OR DATA THAT MAY HAVE BEEN BROUGHT TO THE PROJECT BEFOREHAND. AND THIS ASSURES NON DILUTION OF OUR COLLABORATOR'S IP BY THE CONTRACT AT CRO. SUCCESS WILL BE MEASURED BY: [ READING ] NEXT SLIDE. COUNCIL WILL CONSIDER THE FOLLOWING FEATURES IN THEIR REVIEW, AND ALTHOUGH I WON'T GO INTO EACH OF THESE INDIVIDUALLY, I WANT TO STATE THAT TO DATE, THIS HAS BEEN A VERY SUCCESSFUL MECHANISM FOR FUNDING OUR PROJECTS AND THERE ARE MANY CROs IN THE PRIVATE SECTOR THAT WILL BE ABLE TO COMPETE FOR THIS CONTRACT MECHANISM AND BASICALLY PROVIDE ALL THE SERVICES THAT WE WOULD REQUIRE. NEXT SLIDE. IN SUMMARY: [ READING ] AND IF I COULD HAVE THE LAST SLIDE. SPECIFIC QUESTIONS TO COUNCIL INCLUDE: [ READING ] AT THIS POINT I'D LIKE TO TURP IT OVER TO OUR DISCUSSANTS. >> THANK YOU. I GUESS I CAN GET STARTED. I HAD A COUPLE OF QUESTIONS FOR YOU, MORE TO GET CAUGHT UP ON HISTORY. WHEN THE ORIGINAL CONCEPT WAS CLEARED IN 2015, HOW MANY CONTRACTS HAVE YOU ENDED UP ISSUING IN THE YEARS? >> THAT'S A GOOD QUESTION AND I DON'T HAVE THAT DATA IN FRONT OF ME. THIS MECHANISM IS NOT OUR ONLY WAY TO FUND VARIOUS PROJECT PARTS. WE HAVE THINGS THAT SPAN, PURCHASE ORDER TO SMALLER CONTRACTS THROUGH THE INSIDE FREDRICK FACILITY. AND I JUST RIGHT NOW DON'T HAVE A TOTAL NUMBER THAT I COULD GIVE YOU. BUT I CAN DEFINITELY GET THAT INFORMATION FOR YOU. >> AND HOW MUCH DID YOU END UP SPENDING IN CONTRACTS OVER THOSE YEARS? >> THOSE ARE THINGS THAT WE DON'T DISCUSS IN OPEN SESSION. >> THAT'S FINE. >> WE CAN GET YOU THAT DATA FOR YOUR REVIEW. >> SO THE CONTRACTS YOU DID GET, THAT YOU DID AWARD, WERE THAT ONE ORGANIZATION THAT COULD PROVIDE ALL THE SUITE OF ACTIVITIES OR WAS PHARMACOLOGY ONE CONTRACT, MEDICINE AND CHEMISTRY ANOTHER -- >> EXACTLY. THESE ARE SPLIT UP, COMPETED THROUGH OUR OFFICE OF ACQUISITIONS ON THE STREET AND THEN THERE IS USUALLY A PRIME OF SUBS FOR VARIOUS SUBS THAT PROVIDE VARIOUS PIECES OF THE PRE-CLINICAL PACKAGE THAT WE NORMALLY WORK ON. >> AND YOU CURRENTLY HAVE A PRIME CONTRACTOR AT THE MOMENT? >> NOT ONE THAT I KNOW OF. NO NOT ONE STRAIGHT OFF. >> YOU'RE CURRENT CONTRACTS ARE NOT RUN THROUGH A PRIVATE OF SUBS, JUST ALL DISTRIBUTED? >> YES, DISTRIBUTED. >> OKAY. I HAD ONE MORE QUESTION. JUST GIVE ME A SECOND HERE. >> SURE. >> AND SO THOSE WHO HAVE BEEN -- PROVIDED OR HAVE THE CONTRACT CURRENTLY, THEY ARE ELIGIBLE TO REAPPLY? >> YES. >> SO THOSE ARE THE QUESTIONS FOR NOW. I'LL TURN IT OVER. >> GREAT, THANK YOU. >> THIS IS PROFESSOR HOLE MAN. SO REALLY THIS IS A WONDERFUL PROGRAM. I THINK IT REALLY GIVES NCATS SOME FLEXIBILITY. THE ONE THING I'VE WORKED WITH IN THESE CONTRACTS THROUGH THE NIH, AND I HAVE TALKED TO FRIENDS THAT HAVE AS AS WELL. AND THE ONE THING I AM ALWAYS CURIOUS ABOUT, WHEN A CONTRACTOR IS NOT -- MANY OF THEM DO A WONDERFUL JOB SO DON'T GET ME WRONG THERE. I DON'T WANT TO PAINT A NEGATIVE BRUSH, BUT WHEN THEY ARE NOT UPHOLDING THE CONTRACT, THE SPIRIT OF THE CONTRACT, I GOT A FEELING THAT IT WAS HARD TO HOLD THEM ACCOUNTABLE, BUT I DON'T KNOW THE INNER WORKINGS OF IT VERY WELL. COULD YOU HELP ME UNDERSTAND THAT AND HELP ME UNDERSTAND WHAT THE MECHANISMS ARE TO MAKE SURE THAT THESE CONTRACTS ARE PULLING THEIR WEIGHT? BECAUSE THEY ARE GETTING PAID WELL, I'M ASSUMING. SO HOW DOES THAT WORK? >> SURE, FOR A SPECIFIC TASK, WE USUALLY CONFIGURE IT WITH A BASE PLUS OPTIONS. SO THE OPTIONS ARE CONTINGENT ON MILESTONES AND PROJECT PERFORMANCE SO THEY DON'T ALWAYS GET ALL THE MONEY UPFRONT. SO WE HAVE VARIOUS WAYS TO SHEPERD THEM ALONG OUR PATH THAT WE NEED AND THEN OUR OFFICE OF ACQUISITIONS IS VERY GOOD ABOUT ENFORCING ALL OF THE FEDERAL CONTRACT RULES. IT'S -- THERE ARE A LOT OF OVERSIGHT WITH OUR PROJECT MANAGERS BECAUSE THEY ARE THE WHO UNDERSTANDS THAT HAVE THE DAY-TO-DAY PULSE OF THE PROJECT. THEY ASSURE THAT THE GOVERNMENT GETS ITS VALUE. >> EXACTLY. AND I HAVE SEEN THAT PERSONALLY AND IT'S BEEN NICE. FROM THE PI'S PERSPECTIVE, THERE IS ASTHENIES WE DON'T HAVE A LOT OF CONTROL -- THERE IS A SENSE THAT -- SOMETIMES THERE IS A LIMITED NUMBER OF CONTRACTORS AVAILABLE. SO FROM THIS ONE COLLEAGUE OF MINE, HE FELT HE WAS A LITTLE BIT UP AGAINST A ROCK BECAUSE THERE WASN'T ANY OPTIONS HE HAD TO WORK WITH THIS ONE CONTRACTOR. >> SOMETIMES IT DEPENDS ON THE TECH. IF YOU HAVE ONLY A ONE SHOP THAT CAN PROVIDE A VERY SPECIALIZED SERVICE, THAT COULD BE AN ISSUE. BUT ALL-IN-ALL, I THINK MAJORITY OF OUR PRE-CLINICAL DEVELOPMENT PROJECTS ARE STANDARD CATALOG ITEMS FOR EVERYTHING THAT GOES INTO THE ICHM3 FOR AN IND. >> AND DON'T GET ME WRONG, THE MAJORITY OF THINGS WORK WELL. IT'S FUNNY. WHEN THINGS GO WRONG THAT'S WHEN PEOPLE GET VERY EMOTIONAL ABOUT THINGS. >> SURE. >> THANK YOU VERY MUCH. I APPRECIATE YOUR FEEDBACK. >> THANK YOU. >> ONE OTHER FOLLOW-UP QUESTION. ARE THESE -- IS THE WAY THIS IS STRUCTURED, ARE FOREIGN ENTITIES ALLOWED TO APPLY? >> GOOD QUESTION. I BELIEVE IT'S ALL U.S.-BASED ALTHOUGH DEPENDING ON THE COMPANY, I GUESS THEY COULD HAVE A FOREIGN COMPONENT BUT I'M NOT SURE WHAT THE ACTUAL FEDERAL REGULATIONS ON THAT ARE. BUT EVERYTHING IS WITHIN SPECK BY THE LAW WE ARE REQUIRED TO FOLLOW. >> I GUESS I'M NOT WORRIED SO MUCH ABOUT SPEC, I'M MORE WORRIED ABOUT WHETHER THERE IS FLEXIBILITY FOR THE U.S. TAXPAYER TO SAVE MONEY BECAUSE SOME OF THEM CAN BE DONE MORE ECONOMICALLY IN OTHER SITES OUTSIDE OF THE U.S. >> SURE. WE GO OUT OF OUR WAY TO GET THE MOST VALUE AND UNLESS WE ARE LIMITED BY A PARTICULAR TECHNOLOGY THAT CAN ONLY BE DONE IN ONE PARTICULAR LOCATION, THAT WOULD COME INTO PLAY. BUT ALL-IN-ALL, I THINK THE TAXPAYER GETS ITS VALUE. >> COULD I GET A LITTLE CLARIFICATION, PLEASE? WHO HAS ACCESS TO THESE RESOURCES THAT YOU'RE CONTRACTING FOR? >> EVERYBODY WITHIN THE DIVISION OF PRE-CLINICAL INNOVATION BUT ALSO NCATS WIDE, I BELIEVE. THE WAY IT IS GOING TO BE CONFIGURED IF ANYBODY NEEDS THESE SERVICES. BUT IT IS PRETTY MUCH ALL DTI INTRAMURAL. >> AND NIH DOES NOT CONTRACT FOR THESE SERVICES BROADLY ACROSS NIH? THEY DO IT INSTITUTE BY INSTITUTE? >> I BELIEVE THAT IS THE CASE, YES. >> OKAY. OF THE INDs, HOW MANY HAVE GONE ON TO PHASE II? >> GOOD QUESTION. I DON'T HAVE THAT DATA IN FRONT OF ME BUT WE COULD GET THAT FOR YOU. >> OKAY. >> THERE WERE A COUPLE OF OTHER QUESTIONS IN THE CHAT. I DON'T KNOW IF SOMEBODY WILL READ THEM OUT. I THINK THEY ARE RELEVANT TO THIS. >> THERESA WAS MODERATING THAT PART? >> ACTUALLY I'M MODERATING IT, CLAIRE. SO I WAS GOING TO GET TO THE QUESTIONS. Mr. BRAID EN BERG ASKED THE ESTIMATED ANNUAL COST OF THIS CONTRACT SUPPORT AND WE TYPICALLY DON'T TALK ABOUT NUMBERS IN OPEN SESSION. DR. SOMBER ASKED HIS QUESTION AND YOU ANSWERED. KELLIE HAS A QUESTION. HOW IS THE DEC MECHANISM STRUCTURED TO PROVIDE NON-DILUTION TO COLLABORATORS AND INDUSTRY? LOUIE ANSWERED THAT. IT HELPS THE COLLABORATOR FROM HAVING TO NEGOTIATE WITH THE CONTRACTOR TO OBTAIN ANY NEW IT THAT THEY MAY DEVELOP. SO DEC IS VERY SIMILAR ARRANGEMENT THAT PHARMA AND BIOTECH HAVE BEEN PLACED WITH CROs. >> THANK YOU, LILLY. >> GEORGE BRAID EN BERG ALSO ASKED, 19INDs OVER SIX YEARS. HOW DO WE KNOW THIS IS A GOOD OR EXCELLENT -- WHAT IS THE COMPARATOR? AND PRIVATE SECTOR PLAYERS HAVE ACCESS TO THIS PROGRAM. THE LATTER QUESTION, I BELIEVE, DUANE ANSWERED. THIS IS REALLY FOR INTRAMURAL FOR NCATS. BUT DUANE, WOULD YOU LIKE TO SPEAK TO THE 19INDs OVER SIX YEARS OR PERHAPS ANTON IS ON THE PHONE AND COULD ADDRESS THIS? I THINK HE HAS A BIT MORE HISTORY. >> THE 19 ARE ONES THAT SPECIFICALLY WERE SUPPORTED UNDER THIS CONTRACT MECHANISM. I WANT TO MAKE THAT CLEAR. AND THEN WHAT WAS THE SECOND PART OF THAT? >> IT'S MAINLY HOW WOULD WE JUDGE? GOOD PERFORMANCE? EXCELLENT PERFORMANCE OR WHAT IS THE COMPARATOR? >> WE DON'T REALLY HAVE A SET, DEFINED MATRIX FOR THAT BECAUSE EVERY YEAR IS DIFFERENT. I CAN TELL YOU THAT OUR COLLABORATIVE FUNCTION THAT OCCURS WITH THE THERAPEUTIC DEVELOPMENT BRANCH IS OPEN TO ANYONE ALTHOUGH WE TEND TO BE DISEASE AGNOSTIC AND GO AFTER THINGS THAT ARE RARE OR UNDER FUNDED. SO WE COLLABORATE WITH SMALL BIOTECHS, INTRAMURAL RESEARCHERS AND OTHER ICs, RARE DISEASE FOUNDATIONS, THAT SORT OF THING. AND THE MAJORITY OF OUR PROJECTS COME IN EITHER THROUGH THE BRIDGES OR THE PROGRAM THAT ANTON DESCRIBED YESTERDAY. AND WE TAKE COLD CALLS FOR ANYONE. >> THE CHALLENGE HERE IS NOT KNOWING, BECAUSE YOU'RE NOT ABLE TO SHARE WITH US THE DETAILS OF WHAT IS SPENT, IT'S HARD TO ACTUALLY KNOW WHAT THE VALUE FOR THE 19INDs ARE AND TRYING TO COMPARE ABOUT SPENDING TO GET TO AN IND. I GUESS THE OTHER COMPARATOR, I DON'T KNOW IF YOU HAVE DONE THIS, IS THAT SOME PIs SET UP THE PROGRAMS AT INDS, EVERY GROUP HAS ITS OWN CONTRACTS BUT IT'S THE BENCHMARK ACROSS THE NIH IN TERMS OF YOUR PERFORMANCE WITH THESE CONTRACTS. >> AS FAR AS I KNOW, TDB, SPECIFICALLY, IS UNIQUE AT THE NIH. WE ARE ABOUT THE CLOSEST THING TO A PRE-CLINICAL CRO THAT WE HAVE. SO WE ARE KIND OF IN A CLASS BY OURSELVES. >> WELL, I MEAN THE NINDS PROGRAM HAS THERAPEUTICS WHICH I SET UP 10 YEARS AGO THAT -- >> ISN'T THAT PRIMARILY EXTRAMURAL? >> IT DOESN'T MATTER IF IT'S INTRAMURAL OR EXTRAMURAL. THE QUESTION IS HOW MUCH ARE YOU SPENDING ON THE CONTRACTS TO GET A SENSE OF HOW MANY INDs YOU'RE GETTING. THE ONLY THING MA MAKES THE DIFFERENCE WHERE THE IDEA IS COMING FROM. >> I THINK I MIGHT REFER THAT TO MY BRANCH CHIEF. Y SEE HE HAS HIS HAND UP. >> YES, HI. MAYBE I CAN MAKE A QUICK GENERAL COMMENT, ALTHOUGH WE SHOULDN'T BE TALKING ABOUT EXACT FIGURES BUT A GENERAL OUTLINE OF ORDER OF MAGNITUDE. AND I THINK IF WE COMPARE TO OTHER PROGRAMS, PARTICULARLY COMPARING TO THE OUTSIDE AND THE INVESTMENT WORLD, I THINK HAVING AN AVERAGE OF 3-4INDs CONSISTENTLY OVER A DECADE IS ACTUALLY QUITE HIGH. I THINK PROFESSOR LOW ACTUALLY HAS A MUCH BETTER BROAD PERSPECTIVE OVER THE PULSE SECTOR BUT I THINK IF YOU WERE COMPARE OUR PRODUCTIVITY TO RELATIVELY SIMILAR-SIZE OPERATIONS IN OTHER SECTORS IN THE PRIVATE SECTOR, I WOULD SAY THAT IS QUITE IMPRESSIVE NUMBER. >> I DON'T KNOW IF IT'S POSSIBLE AT SOME OTHER TIME OR CLOSED SESSION, I WOULD BE INTERESTED TO SEE ACTUAL DATA. >> SURE, ABSOLUTELY. >> SO FOR THE QUESTIONS FOR COUNCIL, WHAT MIGHT IMPROVE THIS CONCEPT? I HAVE INTERACTED WITH THE PROGRAM BEFORE AND WHAT I WOULD SAY IS, IT'S OUTWARD FACE IS A LITTLE BIT CRYPTIC UNLESS YOU REALLY HAVE SOME GOOD INSIDER INFORMATION. SO I WOULD SAY FROM THE STANDPOINT -- I LIVE IN DC SO IT WAS EASY TO VISIT AND TALK THROUGH THINGS BUT I DO THINK IT'S OUTWARD-FACED. WHO CAN ACCESS IT AND WHAT THEY CAN ACCESS FOR FOR THESE TYPES OF PARTNERSHIPS -- YOU COULD PROBABLY DO A BETTER JOB OF MAKING THAT CLEARER. >> GREAT. >> SO NOTED, SIR. >> THANK YOU. >> OKAY AND I BELIEVE THIS WAS SO FAR THE LAST QUESTION. HOW MANY INVESTIGATORS MAKE UP THE DENOMINATOR FOR THE 19? AND PROBABLY -- >> WOW. I WOULD HAVE TO DO A FULL PORTFOLIO ANALYSIS FOR YOU AND GET THOSE FIGURES TO YOU SEPARATELY. >> JUST A ROUGH -- >> I CAN GIVE YOU ANOTHER KIND OF ANSWER, WHICH IS THAT OUR OVERALL SUCCESS RATE IN IND CLEARANCE IS OVER PROJECT. SO THE SUCCESS RATE OF PROJECTS REACHING IND IS WELL ABOVE HALF. THAT GIVES YOU AN OUTLINE. >> SO DON, I THINK PERHAPS THE QUESTION WAS GETTING AT, LIKE IF YOU HAVE 19, DO YOU HAVE 19 INVESTIGATORS OR DO YOU HAVE THREE INVESTIGATORS? IT'S A PRETTY BROAD -- >> SORRY. EACH ONE REPRESENTS AN INVESTIGATOR TEAM. SO FOR EXAMPLE, IF IT'S AN ACADEMIC COLLABORATOR WE WOULD SAY AT LEAST HALF OR MORE OF OUR PROJECTS TEND TO BE COLLABORATIONS WITH BIOTECH COMPANIES. SO IT'S NOT INVESTIGATOR, PER SE BUT THE ENTITY. >> I GUESS MY -- LET ME MAYBE I'M NOT BEING CLEAR. MY QUESTION WAS REALLY GIVEN THIS IS PRIMARILY TWO INTRAMURAL PROJECTS, THE NUMBER OF INVESTIGATORS AT NIH THAT HAVE ACCESS TO THIS PROGRAM BENEFIT FROM THESE SERVICES, WOULD BE -- >> GOT YOU. JUST TO CLARIFY. SO NONE OF THE PROJECTS -- ESSENTIALLY NONE OF THE PROJECTS ORIGINATE IN TERMS OFIDATION. THESE ARE ALL COLLABORATIONS. FOR THE MOST PART THE COLLABORATIONS ARE EXTERNAL. EXTERNAL ACADEMIC GROUPS OR BIOTECHS. AND RELATIVELY SMALL FRACTION, MAYBE 20%, ARE WITH OTHER INVESTIGATORS AT THE NIH WITH OTHER ICs. SO THAT GIVES YOU A ROUGH IDEA? >> CLOSER. HOW MANY PROJECTS ARE WE TALKING ABOUT THAT WENT TO IND? HOW MANY HAVE YOU DONE SINCE 2015? JUST A ROUGH NUMBER? I WON'T HOLD YOU TO IT. >> OKAY, 25-ISH. BECAUSE THESE ARE ALL OBVIOUSLY -- THE LIFETIME OF THESE STUDIES PERHAPS FIVE YEARS AND SO THAT SAN ARBITRARY THOUGHT. >> YOU GOT ALMOST 70% -- YOU GO ABOUT 75% OF YOUR PROJECTS CONVERTING TO INDs? >> PRETTY IMPRESSIVE. >> AND SOME PROJECTS, I'M SORRY, SOME PROJECTS DON'T ALWAYS LEAD TO AN IND. WE HAVE PROJECTS WE HELPED PEOPLE FOR SIMPLE FORMULATIONS FOR CLINICAL TRIALS AND STUFF LIKE THAT. >> ABSOLUTELY. >> STILL 25 AND 19 OF THOSE GOING FORWARD SEEMS PRETTY HIGH TO ME FROM THE ACADEMIC WORLD. >> SO THERE IS AN OLD ADAGE IN THE BIOTECH WORLD WHICH IS, MOST BIOTECHS FAILURE BECAUSE THEY RUN OUT OF MONEY OR DON'T HAVE THE RIGHT MANAGEMENT OR RESOURCES AND NEVER GET TO THE CRITICAL PROOF-OF-CONCEPT, EITHER PRE-CLINICAL OR CLINICALLY. SO I THINK OUR MODEL OF COLLABORATION ALLOWS US TO ABSORB A LOT OF THAT RISK SO THAT AS A NET RESULT, OUR IND'S SUCCESS RATE BEATS WHAT YOU SEE IN THE WILD, SO TO SPEAK. >> THANK YOU. AND THERE WAS ANOTHER QUESTION FROM GEORGE BRAIDENBURG ASKING SOUNDS LIKE BIOTECHS CAN ACCESS THIS PROGRAM. IT'S NOT JUST INTRAMURAL PIs. SO DON, COULD YOU JUST TOUCH AGAIN ON THE PARTNERSHIPS AND HOW THAT -- >> SURE. I THINK IT'S A SYMANTEC. OUTSIDE BIOTECHS CAN ACCESS OUR PROGRAM AND OUR PROGRAM, MORE THAN HALF OF OUR PROJECTS ARE WITH BIOTECH COMPANIES BUT THEY CAN'T DIRECTLY ACCESS THE CONTRACTS. WE ARE NOT A PASSTHROUGH TO THE CONTRACT MECHANISM. FATHER WE ENTER INTO A COLLABORATION WITH AN EXTERNAL BIOTECH, THEN WE DO SOME WORK ON OUR SIDE OF THE RESEARCH IN HOUSE AND A LOT OF IT THROUGH THESE CONTRACT MECHANISMS. IS THAT CLEAR? DOES THAT HELP? >> NOT REALLY. SO I'M JUST SAYING, IT GOES A LITTLE TO MARSHA'S QUESTION ABOUT THE INTERFACE. WAS THE INTERFACE WITH EXTERNAL WORLDS? I WAS ABOUT TO ASK THE QUESTION AT THIS LEVEL OF PERFORMANCE, IF YOU DOUBLED YOUR BUDGET, COULD YOU HANDLE 50 PROJECTS OVER FIVE YEARS AS OPPOSED TO 25? >> WELL, AS ANTON WAS REFERRING TO YESTERDAY, WE HAVE A CORE BUDGET OF A CERTAIN AMOUNT THAT IS KIND OF LIKE OUR HARD SUPPORT. AND THEN OVER THE LAST FEW YEARS AND IN THE FUTURE, WE ARE LOOKING AT, IN FACT, SIGNIFICANT EXPANSION OF RESOURCE FUNDING AVAILABLE THROUGH SOFTWARE MECHANISMS LIKE HEAL. SO INDEED, OUR TEAM HAS BEEN PRETTY GOOD AT BEING ABLE TO EXPAND THE NUMBER OF PROJECTS WE CAN HELP PROSECUTE AND COLLABORATE WITHOUT EXPANDING OUR STAFF VERY MUCH. FOR A LARGE PART BECAUSE WE ARE ABLE TO LEVERAGE A LOT OF WORK THROUGH THESE CONTRACT MECHANISMS. AND IN TERMS OF WHAT MARSHA WAS REFERRING TO, I TOTALLY AGREE. WE ARE A BIT CRYPTIC. IT'S HARD TO UNDERSTAND HOW TO GET IN TOUCH WITH US. SINCE I HAVE BEEN HERE, ONLY ABOUT FOUR YEARS, I TRIED TO HAVE A OPEN DOOR. I PERSONALLY TAKE CARE OF EVERY PHONE CALL THAT COMES THROUGH OUR WEBSITE SO WE HAVE A CHANCE OF EXPLAINING HOW THE PROJECT WORKS. AND LIKE ANTON SAID YESTERDAY, IT'S KIND OF LIKE A VERSION OF THE EXTRAMURAL PROGRAM. SO NOT WITH THE STUDY SECTIONS AS ANTON MENTIONED, BUT RATHER INTERNAL REVIEW PROCESS THAT INVOLVES EXTERNAL EXPERT ADVICE TO OUR SYSTEM. BUT FROM THE APPLICANT POINT OF VIEW, IT KIND OF LOOKS LIKE A -- IT LOOKS REMINISCENT TO AN APPLICATION IN THE EXTERNAL WORLD IT'S A SIMILAR PROPOSAL FOR US AND REVIEWED IN A DIFFERENT WAY. >> BUT IT'S PURELY AN IN-KIND SCIENTIFIC COLLABORATION. THERE IS NO MONEY PASSED THROUGH? >> THAT'S RIGHT. SO NO GRANTS. NOTHING LIKE THAT. AND AGAIN, THE COLLABORATOR DOES NOT HAVE DIRECT ACCESS TO THE CONTRACT MECHANISM WE ARE DISCUSSING BUT RATHER THROUGH OUR COLLABORATIVE MODEL ARE ACCESSING THE CONTRACT MECHANISM ESSENTIALLY. WE WOULD PROVIDE THE SUPPORT. >> CAN EACH PROJECT GO UNDER THE WATCHFUL EYE OF A DEDICATEED PROJECT MANAGER IN MOST CASES? >> OKAY. I THINK WE HAVE ONE LAST QUESTION HERE AND THEN WE NEED TO MOVE TO THE NEXT PORTION N DR. HARRIS, WHERE DOES THEIDATION START? INTRAMURAL OR OUTSIDE? >> OUTSIDE. >> SORRY. >> IN MOST CASES, ALTHOUGH I THINK WE HAVE ONE OR TWO HOME-GROWN PROJECTS. ANTON TOUCHED ON THAT YESTERDAY. I BELIEVE THERE WAS ONE EXAMPLE RECENTLY. I DON'T RECALL THE ACTUAL THERAPEUTIC AREA. IT WASN'T WITHIN TDB. >> OKAY. ANNA WE'LL TURN IT BACK OVER TO YOU. >> THANK YOU, EVERYBODY. >> GREAT, THIS IS ANNA. NOW THAT WE ARE DONE WITH OUR DISCUSSION, WHICH REALLY WAS A ROBUST DISCUSSION, THANK YOU, IT'S TIME FOR A MOTION TO APPROVE THE CONCEPT. DO I HAVE A MOTION? >> SO MOTIONED. >> SECOND? >> SECOND. >> ALL IN FAVOR. >> AYE. >> ANY OPPOSED? ANY ABSTENTIONS? HEARING NONE, THE CONCEPT IS APPROVED. OUR NEXT CONCEPT IS GOING TO BE INTRODUCED BY DR. COLVIS. >> HI. I'M CHRISTINE COLVIS. I REPRESENT A SMALL GROUP WE REFER TO AS THE DRUG DEVELOPMENT PARTNERSHIP PROGRAM. SO IT SITS IN THE OFFICE OF THE DIRECTOR AT NCATS AND TODAY ONE OF MY STAFF MEMBERS, DR. TYLER BECK, WILL BE TELLING YOU ABOUT A CONCEPT ANOTHER COLLEAGUE OF MINE, AND I CONCEIVED SEVERAL YEARS AGO BUT HAVEN'T HAD THE BANDWIDTH TO PURSUE THIS. FOR ME THIS IDEA IS BORNE OUT OF MY APPRECIATION FOR THE NIH'S DESIRE TO HAVE RESEARCHERS SHARE THEIR DATA AND AN AWARENESS AT THE SAME TIME RESEARCHERS LIVELIHOODS DEPEND ON PUBLISHING PAPERS. SO THROUGH THIS CONCEPT, WE HOPE TO DEMONSTRATE A MODEL THAT SATISFIES BOTH THE NIH AND THE INVESTIGATORS NEEDS AND THIS IS ALSO ADDRESSING A NEED FOR A MACHINE-READABLE KNOWLEDGE THAT SEVERAL OTHER PROGRAMS OF NCATS HAVE. THE CONCEPT WE THINK IS NOVEL ENOUGH THAT WE WANT TO RUN A SMALL PILOT TO DEMONSTRATE HOW IT WOULD WORK SO PUBLISHERS AND THE NATIONAL LIBRARY OF MEDICINE AND, COULD TAKE UP THE CHARGE IF THERE IS ENOUGH TRACTION. AND THIS PILOT ITSELF IS GOING TO BE ESTABLISHED IN THREE STEPS AND TYLER WILL PRESENT A CONCEPT FOR THE FIRST TWO OF THOSE THREE STEPS. WITH THAT, I WILL HAND IT OVER TO TYLER. >> THANK YOU, CHRISTINE. HI, EVERYONE. I'M TYLER BECK. I'M A PROGRAM OFFICER WORKING ON SEVERAL DIFFERENT PROJECTS WITHIN THE DDP. AND I WANT TO START BY THANKING THE COUNCIL MECHANICS FOR YOUR TIME AND THE OPPORTUNITY TO PRESENT THE CONCEPT. I'M GOING TO BE PRESENTING TO YOU A CONTHAT HE WANT IS STILL IN THE EARLY PLANNING STAGES. WE TURNED THE CONCEPT LIT COIN AND HAS THE POTENTIAL TO FUNDAMENTALLY SHIFT THE WAY THAT RESEARCHERS GET CREDIT FOR THEIR WORK. WE ENVISION AS A PILOT PROGRAM TO CREATE A NEW TYPE OF SCIENTIFIC PUBLICATION WITH ADOPTION BY PUBLISHERS AND RESEARCHERS WHO HAVE A STRONG COMMITMENT TO OPEN DATA SHARING. NEXT SLIDE, PLEASE. AT THIS TIME, THERE ARE RELATIVELY FEW INCENTIVES FOR RESEARCH TOURS SHARE DATA IN OPEN AND MACHINE-READABLE FASHION. WE HAVE A LOT OF DATA SCIENTISTS WHO ARE TRYING TO BUILD KNOWLEDGE FOR PUBLISHED WORKS BUT GENERATING THIS KIND OF COMPUTATIONALLY ACCESSIBLE DATA IS COSTLY AND INVOLVES A LOT OF MANUAL DATA CURATION. AND FINALLY THERE ARE FEW WAYS FOR RESEARCHERS TO SHARE REPRODUCIBLE RESULTS THAT MAY NOT FIT WITHIN THE TYPICAL PUBLICATION STRUCTURE AND STILL GET THEIR CREDITS FOR THEIR WORK. AND WE FEEL THAT FOCUSING ON EARLY-CAREER RESEARCHERS HELPS MAKE THE NEED FOR THIS MORER CHOO. NEXT SLIDE. SO WE ARE PRESENTING A WAY TO INCENTIVIZE AND ENHANCE THE SHARING OF MACHINE-READABLE KNOWLEDGE AND THAT IS A KEYWORD THERE. KNOWLEDGE, NOT JUST DATA. FROM THE FREE TEXT OF RESEARCH PUBLICATIONS. SO I'M GOING TO WALK YOU THROUGH THE CONCEPTUAL FRAMEWORK. A RESEARCHER WOULD MAKE A DISCOVERY USING NORMAL COURSE OF RESEARCH. THIS COULD BE A RELATIVELY SMALL SCALE BUT IMPORTANTLY IS A REPRODUCIBLE OBSERVATION F THIS REPRODUCIBLE OBSERVATION IS NOT NEEDED FOR NEXT BIG PUBLICATION THEY ARE WORKING ON, IT'S LIKELY IT WILL BE NOTED IN A LAB NOTEBOOK OR SAVED IN A FLASH DRIVE AND POTENTIALLY LITTLE ELSE IS DONE WITH IT FOR A MYRIAD OF REASONS, TIME, COST, ET CETERA N THIS PROPOSED PARADIGM I'M SHOWING YOU TODAY, INSTEAD WRITE A SHORT MANUSCRIPT, 1000-2000 WORDS. THE RESEARCHER WOULD GO TO THE HYPOTHETICAL LIT COIN WEB PAGE AND UP LOAD THIS TEXT TO THEIR SERVER. THIS WOULD REQUIRE SUBMISSION OF THE UNDERLYING DATA TO AN OPEN ACCESS DATABASE OF SOME KIND AND ALSO REQUIRES A MINIMUM OF ONE DATA FIGURE ACCOMPANYING THE TEXT. THE LIT COIN SERVER WOULD RUN A NATURAL LANGUAGE PROCESSING 58GRITHM TO IDENTIFY BIOMEDICAL CONCEPTS IN THE TEXT AND ALSO IDENTIFY RELATIONSHIPS BETWEEN THESE CONCEPTS FROM THE TEXT TO BUILD KNOWLEDGE ASSERTIONS. FOR EXAMPLE, IF THERE WAS A SENTENCE THAT SAID, THE COVID-19 VACCINE SHOWED 95% EFFICACY AT REDUCING INFECTION, THE ALGORITHM MIGHT CREATE AN ASSERTION AND THAT COULD LOOK LIKE THIS, COVID-19 VACCINE REDUCES SARS-COV-2 INFECTION. THIS MIGHT ALSO HAVE SOME CONTEXTURAL INFORMATION ASSOCIATED WITH IT BUT THE ASSERTION THAT INCLUDES THE 95% EFFICACY THAT WAS OBSERVED. ASSERTIONS LIKE THIS WOULD BE DISPLAYED TO THE RESEARCHER. THAT RESEARCHER WOULD THEN HAVE THE CHANCE TO VERIFY THE ASSERTIONS AND EDIT THEM IF THEY WERE INCORRECTLY IDENTIFIED. THIS SERVES SEVERAL PURSES. THEY WOULD BE PRE CURATED WITH MUCH LESS CHANCE OF INCORRECT ASUGGESTIONS WHICH WOULD CUT DOWN ON THE NEEDED POST CURATIONING AND CREATE A TRAINING DATA FOR THE NLP ALGORITHM TO IMPROVE ACCURACY MOVING FORWARD. AFTER VERIFYING THIS IS CORRECT, THE RESEARCHER WOULD CHOOSE FROM A LIS OF PARTNERS AND DOWNLOAD A SUBMISSION PACKAGE FROM THE SERVER THAT IS SPECIFIC FOR THAT PUBLISHING GROUP. THEY WOULD TAKE THAT SUBMISSION PACKAGE TO THE PUBLISHER'S WEBSITE AND SUBMIT TO BE PUBLISHED. THE LIT COIN SUBMISSION WOULD BE REVIEWED THROUGH THAT PUBLISHER'S NORMAL REVIEW PROCESS AND WE ENVISION THAT REVIEWERS WILL HAVE ACCESS TO THE KNOWLEDGE ASSERTIONS AND THE ABILITY TO CONFIRM THE ASSERTIONS ARE SUPPORTED BY THE TEXT AND UNDERLYING OPEN DATA SUBMISSION. NEXT SLIDE. IF THE LIT COIN WAS FAVORABLY REVIEWED, IT WOULD BE PUBLISHED LIKE ANY OTHER PAPER AND GET CITATIONS. NEXT SLIDE. AND THAT WOULD LEAD TO DATA REVIEWS FROM THE ASSOCIATED OPEN DATA INCLUDED AS PART OF THE SUBMISSION. IN ADDITION THE PUBLISHER WOULD INFORM THE LIT COIN SERVER IT WAS APPROVED FOR PUBLICATION AT THE TIME THE ASSERTIONS FROM THE SUBMISSION WOULD BE DEPOSITED INTO AN ASSERTION KNOWLEDGE BASE AND ACCESSIBLE TO RESEARCHERS. WITH EACH ASSERTION REFERENCING THE PUBLISHED LIT COIN THROUGH METADATA. TODAY'S CONCEPT CLEARANCE IS FOR TWO CHALLENGED PRIZE COMPETITION TO GET US A LONG WAY TOWARDS THAT CONCEPT AND GIVE NCATS THE OPPORTUNITY TO FLUSH OUT THE IDEA MORE WHILE MAKING SOLID STEPS FOR SMALL FINANCIAL INVESTMENTS. THE FIRST CHALLENGE WILL ENTAIL PROCURING NLP ALGORITHM TO GENERATE MACHINE READABLE KNOWLEDGE FROM FREE TEXT SHOWING UTILITY FOR NCATS FOR OTHER PROGRAMS SUCH AS BIOMEDICAL DATA TRANSLATOR AND THE GENETIC AND RARE DISEASES INFORMATION CENTER CENTER. THE SECOND CHALLENGE WILL FOCUS ON THE BROADER IDEA AS A WHOLE GIVING NCATS THE CHANCE TO SYNTHESIZE CONCEPTUAL FRAMEWORKS FROM MULTIPLE SOURCES IN ORDER TO CREATE THE MOST INNOVATIVE IMPLEMENTATION OF THE OVERALL CONCEPT. WE HOPE TO DEMONSTRATE FEASIBILITY OF THE CONCEPT THROUGH A PILOT AND THEN DISSEMINATE IT THROUGH KEY PARTNERS IN ACADEMIA, GOVERNMENT AND THE PRIVATE SECTOR. WE EXPECT TO RUN THE FIRST PRIZED COMPETITION LATER THIS YEAR AND THIS WILL AND CONTESTANTS TO SUBMIT SOFTWARE TO GENERATE ACCURATE, COMPUTATIONALLY ACCESSIBLE DATA FROM FREE TEXT. ALL CONTESTANTS WILL BE REQUIRED TO GRANT NIH A LICENSE FOR THE SMITTY SOFTWARE TO ALLOW US TO USE IT IN PERPETUITY. THE SECOND CHALLENGE WILL RUN NEXT FISCAL YEAR TO GENERATE END-TO-END PLANS TO BUILD THE PLATFORM, STORY BORING, USER FEEDBACK AND A LONG-TERM PLAN FOR SUSTAINABILITY. THERE WILL BE MULTIPLE SUBMISSION THAT PROPOSE DIFFERENT SOLUTIONS AND WE COULD MIX-AND-MATCH SOLUTIONS FOR BUILDING OUT THE SUBMISSION PLATFORM FOR THE PILOT PROGRAM AND THIS WOULD BE BROUGHT AS A CONCEPT FOR CLEARANCE LATER ON. FINAL SLIDE, PLEASE. SO IN SUMMARY, WE LIKE TO RUN TWO CHALLENGE PRIZE COMPETITIONS, ONE TO CREATE THE NLP COMPONENT OF THE LARGER CONCEPT AND THEN GENERATE INNOVATIVE WAYS TO USE IT TO INCENTIVIZE DATA SHARING. WE HOPE TO LEVERAGE CURRENT EVERYONE'S WHEN DOING SO ALLOWING US TO JUMPSTART THE DEVELOPMENT FOR PILOT PROJECT WITH MINIMAL UPFRONT COSTS. WE'LL ALSO BE OPTIMIZING THE LARGER SYSTEM DESIGN BY EMERGING BEST ELEMENTS MULTIPLE DESIGN IDEAS PROCURED THROUGH THE SECOND CHALLENGE. IN ORDER TO ENGAGE STAKEHOLDERS FOR FEEDBACK ON THE LARGER CONCEPT, WE ARE PLANNING A VIRTUAL WORKSHOP TO BE HELD NEXT THURSDAY AND FRIDAY, 17 AND 18 OF JUNIOR. WE HAVE 6 PARTNERS PLANNING TO PARTICIPATE AND ALSO HAVE SEVERAL COLLEAGUES FROM THE NATIONAL LIBRARY OF MEDICINE WHO ARE VERY INTERESTED IN THIS CONCEPT. NEXT SLIDE. WE HAVE SEVERAL QUESTIONS THAT WE FEEL COUNCIL MEMBERS CAN HELP US ADDRESS, INCLUDING WAYS TO IMPROVE THE OVERALL INITIATIVE, WHAT FACTORS MIGHT BE KEY TO THE SUCCESS OF THE PROGRAM IN THE LONG RUN AND HOW TO WORK EARLY ON TO MAKE SURE ADOPTION AND DISSEMINATION OF THE IDEA HAPPENS. AND WITH THAT, THANK YOU VERY MUCH FOR THE OPPORTUNITY TO TALK ABOUT THE IDEA AND I'M HAPPY TO TURN THIS OVER TO DR.S HARRIS AND CRESSLER AS OUR DISCUSSANTS. >> THANK YOU. THAT WAS A HELPFUL PRESENTATION. I HAVE A NUMBER OF COMMENTS AND A NUMBER OF QUESTIONS. SO I'LL START AND INVITE MIDLEG ALSO JUMP IN WHENEVER. I GUESS GOING BACK A SLIDE, YOU MENTIONED THE INFORMATION SESSION OR THE STAKEHOLDER ENGAGEMENT SESSION. YOU DIDN'T MENTION THAT YOU WERE GOING TO HAVE RESEARCHERS IN THAT SESSION AS EXPERTS. IS THAT PLANNED? >> YES. SO WE HAVE FIVE PANELS PLANNED DURING THE WORKSHOP NEXT WEEK. ONE OF THE PANELS IS VERY FOCUSED ON THE PUBLISHERS AND SEVERAL OTHERS ON DIFFERENT RESEARCHER AND STAKEHOLDERS IN DIFFERENT FIELDS. SO A FEW OF THEM FOCUSED MORE ON THE NATURAL LANGUAGE PROCESSING AND A FEW MORE FOCUSED ON HOW RESEARCHERS CURRENTLY PRESENT AND SHARE THEIR DATA AND HOW THAT CAN BE IMPROVED. >> OKAY. SO I THINK AS I WAS READING THE NARRATIVE PIECE OF THIS, NOT THE SLIDES, ONE OF THE THINGS I KEPT GOING BACK TO WAS WHETHER YOU WERE THINKING THAT THIS, YOU AND THE PUBLISHERS ARE THINKING THAT THIS SORT OF SMALL MICRODISCOVERY OF PUBLICATION WOULD BE A SPECIAL TYPE OF -- A SPECIAL CLASS OF PUBLICATION WITHIN THE PUBLISHER'S PORTFOLIO OR THE JOURNAL'S PORTFOLIO? >> WE ARE RIGHT NOW ENVISIONING THIS AS BEING A NEW PUBLICATION TYPE. SO SOMETHING LIKE RESEARCH ARTICLE OR LETTER TO THE EDITOR. IT WOULD BE A NEW CATEGORY OF ARTICLES THAT WOULD GO INTO EXISTING JOURNALS. AND THESE WOULD BE JOURNALS VERY FOCUSED ON OPEN DATA SHARING AND THINGS LIKE THAT. AND THERE IS STILL A LOT TO WORK OUT. ONE OF THE REASONS WE ARE HAVING THIS WORKSHOP NEXT WEEK IS TO GET THE PUBLISHERS VIEWPOINTS ON HOW BEST TO MAKE THAT FIT WITHIN THEIR PARADIGM AND HOW BEST TO MAKE IT FIT WITHIN THEIR REVIEW PROCESS AND THINGS LIKE THAT. >> AND WHEN YOU SAY PUBLISH, I'M ASSUMING YOU'RE GOING TO THE LEVEL OF EDITORS? >> YES, WE HAVE SEVERAL EDITORS THAT ARE PART OF THE PANELS AND SEVERAL PEOPLE WHO WORK MORE ON THE ACTUAL PUBLISHING SIDE. BUT YES WE HAVE EDITORS AND PUBLISHERS. >> AND HOW ABOUT REVIEWERS? >> WE DON'T REALLY HAVE A SPECIFIC SESSION FOCUSED ON REVIEWERS DURING THE WORKSHOP, BUT I FEEL LIKE WE COULD DEFINITELY GET THAT FEEDBACK THROUGH SOME MORE TARGETED WORK AFTER THAT. >> WHEN YOU'RE SUBMITTING FOR THE ASSERTION GENERATION, WHY DO YOU NEED THE FIGURE? >> I THINK THE REASON WE WANT TO HAVE A FIGURE IS FOR THE SAKE OF BEING ABLE TO MAKE SURE THAT THERE IS DATA ASSOCIATED WITH THE PROJECT AND IT'S NOT JUST BEING INCLUDED JUST AS TEXT. I THINK THAT BASICALLY THE IDEA THERE IS TO HAVE A FIGURE THAT IS REPRESENTATIVE OF THE UNDERLYING DATA THAT WAS SUBMITTED TO AN OPEN DATA SOURCE. AND SO WE REALLY WANT TO MAKE SURE THIS IS NOT JUST A LITTLE PIECE OF TEXT THAT GETS STUCK INTO THE JOURNAL BUT THAT IT STILL REPRESENTS A RESEARCH DISCOVERY. >> BUT WILL YOU BE DOING ANYTHING WITH THE JOURNAL? SORRY, THE FIGURE? >> OUR HOPE WOULD BE THE FIGURE WOULD BE INCLUDED WITH THE SUBMISSION IN THE JOURNAL AND THEN THE -- IT DEPENDS ON WHAT TYPE OF DATA IT IS. IT MAY BE THAT THE FIGURE IS THE ACTUAL SUBMITTED UNDERLYING DATA DEPENDING ON THE TYPE OF INFORMATION THAT THE RESEARCHERS ARE SUBMITTING. >> JUST ONE OTHER QUESTION WOULD BE -- I LOOKED AT THIS FROM THE EYES OF A SYSTEM DEVELOPER, I KEPT THINKING, I DO THE CONTEST IN THE OPPOSITE ORDER BECAUSE IF YOU CAN'T GET THE USE CASE WELL DEVELOPED AND DESIGNED, IF YOU DON'T HAVE CONFIDENCE IN THE USE CASE, THEN THE METHODS DEVELOPMENT DOESN'T REALLY MATTER. IS THERE A REASON THAT YOU KIND OF CHOSEN TO DO THE NLP METHOD WORK FIRST AND THE USE CASE SECOND? >> YES, ACTUALLY. SO THE BIGGEST REASON IS THAT THE NLP ALGORITHM WE GET FROM THIS FIRST CHALLENGE COULD BE USEFUL TO NCATS PROGRAMS REGARDLESS OF THE LIT COIN PROGRAM MOVING FORWARD IN AND OF ITSELF. SO WE COULD MAKE USE OF THAT ALGORITHM TO ANALYZE BIOMEDICAL TEXT FOR THE BIOMEDICAL DATA TRANSLATOR OR POTENTIALLY FOR GUARD OR A MEREIAT OF OTHER PROJECTS. WE FEEL LIKE THE NLP DESIGN IN AND OF ITSELF AND GETTING THE MOST VALUE OUT OF A PROCURING NEW ALGORITHM WILL BE USEFUL TO NCATS REGARDLESS OF MOVING FORWARD IN THE REST OF THE PROJECT. >> SO IF THE USE CASE AND THE SYSTEM PIECE OF IT FAILED, YOU STILL HAVE THIS? >> EXACTLY. AT LEAST PARTIALLY. >> YOU MENTIONED A THIRD COMPONENT THAT WASN'T DISCUSSED. WHAT IS THE THIRD? >> THE THIRD COMPONENT WOULD BE ANOTHER CONCEPT WE WOULD EVENTUALLY BRING FORWARD FOR BUILDING OUT THE LIT COIN SUBMISSION SERVER AND THE LARGER SYSTEM. BUT WE WANT TO MAKE SURE THAT WE -- ONE OF THE REASONS WE WANT TO DO A CHALLENGE FOR THE CONCEPT, CONCEPTUAL FRAMEWORK ITSELF IS THAT WE REALLY WANT THIS TO BE AS INNOVATIVE AS POSSIBLE AND MAKE SURE THAT IT GETS AS MUCH INTEREST FROM STAKEHOLDERS AS POSSIBLE AND WE FEEL LIKE RUNNING THE CONCEPTUAL CHALLENGE TO BUILD THE LARGER, WHOLE SYSTEM, WILL BE A REALLY GOO GOOD WAY TO DO THAT. >> OKAY. AND ONE MORE. THANK YOU FOR TAKING THESE QUESTIONS. ONE MORE COMMENT, TAKE IT OR LEAVE IT. BUT THE LIT COIN STRUCK ME THE NAMING OF IT STRUCK ME AS KIND OF CLEVER BUT ALSO A LITTLE BIT OF RISK THERE IN THAT PEOPLE ARE THINKING ABOUT BITCOIN AND IF BITCOIN GOES BELLY UP OR THE REPUTATION SUFFERS, YOUR NAME WOULD SUFFER AS WELL. WE HAD THAT HAPPEN A COUPLE OF TIMES, MOST NOTABLY WITH A GROUP CALLED ISIS A FEW YEARS AGO. AND THEY WERE LIKE, WE WEREN'T ISIS, BUT IT HURT OUR REPUTATION REPUTATION. >> I UNDERSTAND THAT AND THE NAME REALLY IT DID COME OUT OF THE SORT OF CONCEPT OF BITCOIN WHERE YOU HAVE A LARGE NETWORK THAT IS DISTRIBUTED AND ALLOWS YOU TO FOLLOW THINGS FROM BEGINNING TO END. AND THAT SORT OF -- WE WOULD LOVE THIS TO BECOME IN THE LONG TERM AFTER THIS PILOT, TO BECOME A PLACE FOR FOLLOWING RESEARCH, NOT JUST RESEARCHERS BUT ALSO THE PUBLICATION THAT IS COME OUT OF IT, FOLLOWING THEM FROM BEGINNING ALL THE WAY TO THE LATER WORK THAT IS BESIDES THEM. SO THAT'S WHERE THE NAME ORIGINALLY CAME FROM. AND CHRISTINE CAN SPEAK TO THAT MORE THAN I CAN EVEN. >> THANK YOU. IT REALLY IS A DOUBLE-EDGED SWORD AND I THINK OUR THINKING WAS REALLY TO TRY TO CHANGE THE CURRENCY OF ACADEMIA, WHICH RIGHT NOW ARE THESE FULL-BLOWN PUBLICATIONS WHICH WOULD BE LIKE THE PAPER MONEY. AND THAT BY HAVING THESE SORT OF LITTLE PIECES OF KNOWLEDGE THAT ARE REPRODUCIBLE AND YOU SEE OVER AND OVER AGAIN, THAT MAYBE VERY, VERY USEFUL TO ANOTHER INVESTIGATOR TO GIVE THOSE A PLATFORM TO BE SHARED AND HAVE THE MACHINE READABLE AND DO THE TYPES OF THINGS THAT TYLER WAS MENTIONING. >> THANK YOU. I HAD A BUNCH OF SMALL THOUGHTS AS WELL BUT I THINK ALL OF THOSE THOUGHTS ARE GOING TO COME OUT IN YOUR SESSION NEXT WEEK WHERE YOU'RE GETTING DOWN INTO THE WEEDS. THANK YOU. >> THANK YOU. >> WE SHOULD MOVE ON TO -- [ MULTIPLE SPEAKERS ] >> [ INDISCERNIBLE ] WE ARE LOSING A LOT OF FEDERALLY-FUNDED RESEARCH DATA AND THE STATED KNOW IN THE CONCEPT. WHAT IS CRITICALLY COMPREHENSIVE STAKEHOLDER ENGAGEMENT NEXT WEEK, REALLY MAKE SURE YOU HAVE ALL ON THE TABLE -- SOME POTENTIAL NEED ON ANTICIPATED CONCEPT CLEARANCES OF YOUR ACTIVITIES. THIS ACTIVITY HAS TO BE IMPACTFUL FOR JUNIOR INVESTIGATORS. JUNIOR INVESTIGATORS ARE CRITICAL FOR THEIR CAREER SO THE -- IT HAS TO BE EQUIVALENT AND ADD UP TO THE PAPER MONEY CURRENTLY. >> ABSOLUTELY. >> AND THAT WAS A COMMENT YOU HAD EARLIER. HOW IS THIS STACKED AGAINST THE OTHER CURRENCIES AND PUBLICATIONS? IF THIS IS FALLING INTO A LEVEL OF CASE REPORT WHICH DO NOT COUNT FOR PROMOTION AND BETTER LIMITED FOR INVESTIGATORS TO WORK HERE. IF THIS FALL INTUSE A SHORT COMMUNICATION FRAMEWORK. THAT IS COMMUNICATIONS INVESTIGATORS AND ACADEMIC ENTITIES AND REPRESENTORS MIGHT BE HELPFUL AND I WOULD HOPE THAT SOME OF THEM -- [ INAUDIBLE ] >> ABSOLUTELY. I THINK IN OUR MINDS THIS DEFINITELY FITS SOMEWHERE BETWEEN THE SORT OF STANDARD RESEARCH ARTICLE AND SOMETHING -- RIGHT NOW WE HAVE A LOT OF WAYS TO DO, TO GET DATA OUT THERE THAT IS NOT PEER-REVIEWED AND SO ONE OF THE REASONS THAT WE WANTED TO INSERT THIS INTO THE STANDARD REVIEW PROCESS IS SO THAT PEOPLE CAN FEEL LIKE WHAT COMES OUT OF THESE ARE NOT JUST SMALL BITS OF INFORMATION, BUT SMALL ARTICLES THAT SHOULD HOPEFULLY COUNT TOWARDS PEOPLE'S CAREER. SO THAT'S WHY WE WANTED TO START THIS PILOT PROGRAM WITH THE NOTION THAT IT'S ALL PART OF THE STANDARD PUBLISHING PIPELINE TO GIVE PEOPLE REALLY THAT FEELING OF THE DATA THAT COMES OUT OF THIS IS GOING TO BE GOOD AND USEABLE AND REUSABLE. >> AND I FULLY AGREE THERE IS A CONCEPT THAT NLM HAS TO BE AT THE TABLE EARLY ON AND REPRESENTED NEXT WEEK BECAUSE DATA WILL BE ALSO THE KEY TO CONCEPT. I WOULD ENCOURAGE YOU TO ENSURE WITH THE PRESENTATION IF THIS IS TO BE ADOPTED, NOT ONLY HAVE TO MODEL FOR U.S. INVESTIGATORS BUT IT HAS TO BE ACCESS AND I BELIEVE UTILIZED ACROSS THE DIFFERENT FRAMEWORKS. MY LAST COMMENT IS FOR THE NLM, MAKE SURE YOU HAVE FROM THE ONCOLOGY COMMUNITY AND MACHINE DATA IS ONE THING. IF THESE ENTITIES ARE BROUGHT INTO EXISTING ONCOLOGYIES THEN -- [ INAUDIBLE ] IT'S CLEARLY AN OPPORTUNITY YOU CAN NOT MISS. IF YOU NOT DONE SO, MAKE SURE YOU HAVE OTHER REPRESENTATIONS AT THE NEXT MEETINGS AND NLM COMPETITION GOALS ARE EXPLAINED ROBUST FRAMEWORK AVAILABLE FOR THE PLETHORA OF SCIENTIFIC KNOWLEDGE YOU WANT TO ENCOMPASS. I LIKE THE CONCEPT A LOT AND YOU HAVE DATA SHARING DISCUSSIONS AND THIS WOULD BE A VERY NICE ADDED ELEMENT TO MAKE SURE FEDERALLY-INVESTIGATOR RESEARCH BECOMES AS USEFUL AS POSSIBLE -- >> THANK YOU FOR THAT. >> THANK YOU. >> I DO HOPE THAT YOU CAN BE PART OF THE WORKSHOP NEXT WEEK OR LISTEN IN. WE ARE ADDRESSING ALMOST ALL OF THE POINTS FOR SURE THAT YOU JUST MENTIONED AND I THINK WE ARE GOING TO HAVE ONTOLOGY EXPERTS ON ONE OF THE PANELS SPECIFICALLY AND I THINK THAT THE WORKSHOP WILL BRING OUT A LOT OF THESE IDEAS. >> THANK YOU. WE ONLY HAVE A FEW MORE MINUTES FOR QUESTIONS. THERE ARE IS CLEARLY A LOT OF INTEREST IN THIS. I'LL GO THROUGH A FEW OF THE ONES IN THE CHAT REALLY QUICKLY. DR. LOWASKED, WHAT IS THE PRIZE THAT WOULD INCENTIVIZE THE PIs TO PARTICIPATE. CAN YOU ANSWER THAT DISTINCTLY? >> ABSOLUTELY. SO THE PRIZE FOR THE PIs WILL BE -- SO WHEN THEY SUBMIT THEIR TEXT AND THE NLP PULLS OUT THE ASSERTIONS ONE OF THE THINGS WE ARE HOPING TO DO IS HAVE THOSE ASSERTIONS COMPARED TO ALL PREVIOUS PUBMED ABSTRACT OR PERHAPS EVEN ALL PREVIOUS PUBMED PAPERS AND TO TELL THE RESEARCHER HOW MANY TIMES A SIMILAR IDEA OR THE SAME ASSERTION WAS MADE IN A PREVIOUS PAPER. AND LINK OUT TO THOSE. SO IT COULD BE NOT ONLY A GOOD EXAMPLE OR GOOD WAY TO DETERMINE HOW NOVEL YOUR IDEA IS, OR HOW NOVEL THE ASSERTION IS THAT YOU'RE MAKING HERE IN YOUR PAPER, BUT ALSO TO HELP YOU BUILD YOUR BIBLIOGRAPHY REALLY VERY QUICKLY. WHICH IS A TIME CONSUMING THING FOR RESEARCHERS. >> AND THE PRIZE WE ARE TALKING ABOUT HERE IS ACTUALLY FOR DEVELOPING THE NL. AND FOR COMING UP WITH THE CONCEPT. SO THE PRIZE ISN'T FOR THE OFFERS. >> RIGHT. EXACTLY. THE INCENTIVE FOR THE RESEARCHER IS THE -- WHAT I JUST DESCRIBED BUT THE PRIZES ARE MEANT FOR THE NLP DESIGN AND BUILDING AND THEN ALSO THE DESIGN OF THE OVERALL FRAMEWORK. >> OKAY. AND WILL DR. BRAID EN BERG WAS ASKING IF A MACHINE READABLE ASSERTION IS ACCEPTED IS THAT ASSERTION CREDITED TO LIT COIN OR TO A JOURNAL SUCH AS NATURE OR SCIENCE? >> SO IT WOULD BE -- I WOULD SAY YOU COULD CONSIDER IT BOTH. SO IT WOULD BE SUBMITTED INTO THE UNDERLYING KNOWLEDGE BASE THAT WE WOULD BE BUILDING FOR LIT COIN AND SO ACCESSIBLE THROUGH THAT KNOWLEDGE GRAFT AND THEN ALSO BE DIRECTLY CONNECTED TO THE SENTENCE OR PHRASE THAT IT WAS PULLED OUT FROM BY THE NLP AND THEN LINKED OUT TO THE PUBLISHED WORK IN THAT WAY. >> WHICH WOULD BE THE LIT COIN. SO IT WOULD BE A PUBLISHED, TO PAULE'S QUESTION IF YOU THINK ABOUT THE REVIEWED ARTICLES, EDITORIALS AND COMMENT AIRS AND PUBLICATIONS, THIS WOULD BE A PRIMARY PUBLICATION. IT WOULD BE A SMALLER PIECE RATHER THAN A LARGE STORY. >> LET'S GO BACK TO THE HARTMAN AND THEN I'LL GO BACK TO A COUPLE IN THE CHAT. >> I'M NOT A DOCTOR BUT THANK YOU FOR THE HONORARY MENTION. SO I HAD A QUESTION FOR CHRISTINE AND TYLER ABOUT THE BITCOIN RELATIONSHIP AND THE LIKELY NAME BECAUSE YOU KNOW THE WHOLE IMPETUS BEHIND BITCOIN WAS THE LEDGER, THE BLOCK CHAIN AND I APPRECIATE THAT THIS WILL BE GREAT. YOU COULD DISTRIBUTE THIS TO A LOT OF NETWORKS REALLY QUICKLY BUT THE REAL BENEFIT AND THE REASON A LOT OF PEOPLE LIKE MY YOUNGER BROTHER FOR THE LAST DECADE MIND BIT COINS IS BECAUSE THERE IS THAT OWNERSHIP AND IT GOES BACK, LIKE IT'S YOURS FOREVER UNLESS YOU LOSE THE PASSWORD OR SOMETHING. IS THERE A BENEFIT TO PEOPLE WHO PARTICIPATE IN TERMS OF SHOWING THAT THEY HAD OWNERSHIP OF WHAT WAS PUT INTO THE SYSTEM FROM THE BEGINNING AS THINGS BUILD FROM THIS? AND WHAT ABOUT THE WHOLE CONCEPT OF ANONYMITY? THAT'S A LOT OF THINGS THAT PEOPLE LOVE ABOUT BITCOIN. >> SO THAT SAY REALLY GOOD POINT. I DO THINK THAT WE IMAGINED THE EACH ASSERTION WOULD BE CONNECTED TO THE RESEARCHER THAT SUBMITTED THE TEXT PROBABLY THROUGH THEIR ORCID AND THEN IN THAT WAY, THEY WOULD BE CREDITED WITH THE ASSERTION AND ALSO CONNECTED TO ANY PREVIOUS INSTANCES OF THAT SAME ASSERTION IN PREVIOUS PAPERS. BUT THE ANONYMITY IS SOMETHING THAT I HAVE A LOT OF -- I WOULD HAVE A LOT OF CONCERN ABOUT. I THINK THAT WE ARE NOT TRYING TO INCREASE ANONYMITY IN SCIENTIFIC RESEARCH IN MY MIND. SO I WOULD SAY THAT'S ONE OF THE BIGGEST PIECES OF BITCOIN LEDGER IDEA THAT WE WOULD TRY TO STAY AWAY FROM IS THE ANONYMITY ASPECT. >> OKAY. WE ARE GOING TO DO ONE LAST -- DR. LOW HAS BEEN TRYING TO RAISE HIS HAND FOR A WHILE AND THE FUNCTION IS NOT WORKING. BUT JUST WANTED TO SAY ANY COUNCIL MEMBERS OR THE PUBLIC HAVE ANY COMMENTS AFTER THIS, PLEASE SEND THEM IN. WE ALSO SAVE THE CHAT, WHICH IS JUST WITHIN THE COUNCIL MEMBERS. SO WE WILL BE ABLE TO ADDRESS THESE AND EVEN COME BACK TO YOU IF WE ARE NOT SURE ABOUT A QUESTION. SO DR. LOW, IF YOU COULD ASK YOUR QUESTION. >> JUST A COUPLE OF COMMENTS AND MAYBE A QUESTION OR TWO. SO THIS IS A REALLY INTERESTING SET OF IDEAS AND I THINK THAT -- LET ME SEPARATE IT INTO TWO PIECES. ONE IS THE IDEA ABOUT GETTING ACADEMICS TO SHARE DITA AND THEY GET CREDIT FOR IT. AND THE SECOND IS TO BE ABLE TO DEVELOP ALGORITHMS THAT COULD TAKE A VARIETY OF PUBLICATIONS AND DISPEL FROM THEM LOGICAL STATEMENTS TO BE PIECED TOGETHER AND USED TO MAKE OTHER INFERENCES. I THINK THOSE TWO SEPARATE THINGS AND THEY PLAY SEPARATE ROLES AND I THINK THAT THIS CONCEPT SHOULD APPLY BOTH BECAUSE THEY ARE BOTH EXCITING. WITH RESPECT TO THE FIRST, I THINK IT IS IMPORTANT IN ORDER TO GET ACADEMICS TO PARTICIPATE, TO BE ABLE TO GIVE THEM CREDIT IN AREAS THEY WANT CREDIT, MAINLY TO HELP THEM GET TENURE AND TO HELP THEM DISSEMINATE THEIR IDEAS. SO I THINK IT WOULD BE CRITICAL TO PARTNER UPFRONT WITH A JOURNAL LIKE SCIENCE, NATURE OR CELL, IF YOU COULD DO THAT, IF THEY ARE WILLING TO DO THAT WITH YOU. THAT WOULD BE REALLY POWERFUL. BUT EVEN IF THEY AREN'T, I MIGHT CONSIDER GOING WITH NET ARCHIVE OR BIOARCHIVE, WHICH IS MUCH MORE OPEN TO THESE KINDS OF PARTNERSHIPS THAN THE TOP JOURNALS. THAT'S THE FIRST THING. >> I'LL SAY WE HAVE BOTH SPRINGER NATURE AND BIOARCHIVE REPRESENTATIVES AT THE WORKSHOP NEXT WEEK ON THE PANEL. SO I'M HOPING TO HEAR GOOD THINGS FROM BOTH OF THEM. >> I WOULD BE PROACTIVE AND INVITE THEM TO CONSIDER PARTNERING WITH YOU GUYS TO DO THIS TOGETHER BECAUSE HAVING A BIOARCHIVE OR A NATURE OR SCIENCE TO BE PARTICIPATING THAT WOULD GET REAL CREDIT AND THEN YOU'LL GET A TON OF PEOPLE TO PARTICIPATE. SECOND ISSUE, I THINK THE COMPUTER SCIENCE FIELD HAS HAD A LOT OF PROGRESS, PARTICULARLY WITH THE AREA CALLED CATEGORY THEORY, WHERE THEY BASICALLY USE SOME VERY ABSTRACT MATHEMATICS DEVELOP LOGICAL MAPPINGS ACROSS DIFFERENT AREAS USING EXACTLY THE KIND OF CONCEPT PATTERNS THAT YOU'RE FOCUSING ON. I WOULD ENCOURAGE YOU TO CONTACT COMPUTER SCIENTISTS IN THE CATEGORY THEORY AREA, INVITE THEM TO THE CONFERENCE AND HAVE THEM INTERACT TO FIGURE OUT -- I THINK THAT IS WHERE YOU OUGHT TO PUT THE CALL FOR THIS CONCEPT AND BE ABLE TO GET THEM TO PARTICIPATE. AND BUT THE LAST THING IS THAT I THINK THAT IN TERMS OF BEING ABLE TO GET THIS OUT THERE, RATHER THAN CREATING A WHOLE NEW CATEGORY OF LIT COIN, WHICH I'M NERVOUS ABOUT THAT ASSOCIATION FOR THE REASONS THAT PAULE HARRIS MENTIONED. YOU COULD APPLY THE ALGORITHMS TO EXISTING PUBLICATIONS AND PAST DATA. IN OTHER WORDS, START BY ASKING PIs TO PLAY WITH THIS AND THEN USE HISTORICAL DATA THAT NO LONGER MATTERS. THE STEAKS ARE MUCH LOWER BECAUSE IF YOU YOU'RE ASKING PEOPLE TO CONTRIBUTE DATA YOU'RE CURRENTLY WORKING ON, THEY MAY BE RELUCTANT. BUT IF YOU ASK THEM TO CONTRIBUTE DATA THEY HAVE DONE 10 YEARS AGO JUST TO SEE HOW THE THING WORKS, THAT MIGHT BE A POWERFUL PROOF-OF-CONCEPT WITHOUT HAVING TO GET THEM TO WORRY ABOUT WHETHER OR NOT THEY ARE GIVING UP SOMETHING PROPRIETARY RIGHT NOW. >> CAN I JUST -- >> THANK YOU VERY MUCH. REALLY FAST BECAUSE WE HAVE A -- >> I GUESS I WANTED TO -- AND TWO PEOPLE SAID THIS. I WANT TO ALSO MAKE IN THE VOCAL SESSION TO SAY I THINK ONE OF THE COMPONENTS WE ENCOURAGE YOU TO CONSIDER IS THE NEGATIVE DATA PIECE, EXPERIMENTS THAT DON'T WORK. WHICH WE ALSO STRUGGLED WITH ESSENTIALLY SETTING IN SHELVES AND LABS AND NEVER COMING OUT THAT COULD INFORM SCIENCE. BUT BOTH OF THESE, WHETHER POSITIVE OR NEGATIVE DATA. I HAVE ONE CONCERN WITH THE VERY FIRST BOX OF YOUR FLOWCHART WHERE I THINK YOU SAID THE WORDS THAT THE DATA SHOULD BE REPRODUCIBLE. AND THAT IS ACHILLES HEAL I WORRY ABOUT FOR YOUR PROGRAM BECAUSE THE ONE INDIVIDUAL WHO DOES IT -- WE HAVE 80% OF NATURE PAPERS THAT ARE REPRODUCIBLE. SO I DON'T QUITE KNOW HOW YOU ARE GOING TO ESSENTIALLY MAKE SURE THAT THIS PARTICULAR OBSERVATION THAT SOMEBODY SUBMITTING IS REPRODUCIBLE. >> IF I COULD CLARIFY. BECAUSE I HEARD SOMEBODY ELSE HAVE A CONFUSION ABOUT THIS. SO MAYBE WE HAVE TO CHANGE OUR REPRESENTATION. YOU MAKE THE OBSERVATION -- EVERY TIME YOU DO THIS EXPERIMENT, YOU SEE THIS OTHER THING. YOU'RE NOT SURE HOW IT RELATES TO YOUR STUDY BUT IT SHOWS UP REPRODUCEIBLY OF WHAT OTHER PEOPLE MIGHT CALL AN ARTIFACT OF YOUR STUTY BUT YOU SEE IT EVERY SINGLE TIME. WE DON'T MEAN REPRODUCIBLE AS IN ANOTHER LAB REPRODUCED IT. SO WE MIGHT BE USING A DIFFERENT WORD BUT THAT IS WHAT WE MEAN. SO WE DON'T -- IN OTHER WORDS WE ARE AVOIDING THE CASE STUDY THING. WHERE ONE TIME I SAW THIS BUT IT'S THAT EVERY TIME I RUN THIS EXPERIMENT, I DID 10 RUNS OF THIS BUT THE PIECE I'M FOCUSING ON IS SOMETHING ELSE BUT I ALSO MAKE THIS OTHER OBSERVATION AND THAT IS THE THING WE WANT TO GIVE PEOPLE A PLATFORM FOR. >> SO YOU'RE GOING TO HAVE TO HAVE A BEFORE YOU'RE ABLE TO HAVE AN ENTRY POINT HERE THEN. >> PROBABLY WILL BE. YES. >> THANK YOU. >> REPEATED. MAYBE REPEATED IS THE BETTER WORD. >> OKAY. THANK YOU, EVERYBODY. THIS IS GREAT THERE IS SO MUCH INTEREST AROUND THIS ONE. TYLER HAS A LOT OF GREAT FEEDBACK. I'M GOING TO TURN IT BACK TO ANNA. >> ALL RIGHT. NOW THAT WE HAVE CONCLUDED OUR DISCUSSION, IS THERE A MOTION TO ADVANCE THIS CONCEPT? >> MOTION. >> IS THERE A SECOND? >> SECOND. >> ALL IN FAVOR. >> AYE. >> OPPOSED? >> THANK YOU. >> I'M SORRY? >> ALL RIGHT SO THE CONCEPT IS APPROVED. WE HEARD THE DISCUSSION AND WE'LL MODIFY, TAKE YOUR CONTRIBUTIONS UNDER ADVISEMENT FOR SURE. ALL RIGHT. SO WE ARE DONE WITH THIS CONCEPT AND NOW WE ARE GOING TO MOVE ON TO THE CTSA SUITE OF CONCEPTS. THE OVERVIEW IS GOING TO BE PROVIDED BY DR. MICHAEL KURILLA WHO IS THE DIRECTOR OF OUR DIVISION OF CLINICAL INNOVATION. MIKE? >> THANK YOU, ANNA. HOPEFULLY EVERYONE CAN HEAR ME. >> WE CAN. >> THANK YOU. SO WE ARE GOING TO PRESENT A SUITE OF CONCEPTS ABOUT THE CTSA AND SO ACTUALLY A THEME YOU'LL HEAR THROUGHOUT RATHER THAN HAVING EACH INDIVIDUAL CONCEPT REPEAT, I'M GOING TO GIVE A LOT OF THE OVERVIEW FOR THE ENTIRE PACKAGE. I'LL TRY TO PROVIDE YOU WITH OUR RATIONAL FOR THE MODIFICATIONS THAT WE ARE SUGGESTING. I'M GOING TO SPEND A LITTLE BIT OF TIME HIGHLIGHTING SOME OF THE LONG TERM SUSTAINABILITY ISSUES WITH THE PROGRAM THAT HAS BEEN PARTLY THE DRIVER FOR WHAT WE ARE TRYING TO ACHIEVE HERE AS WELL AS CONVEY THE LONGTERM VISION FOR THE PROGRAM, PARTICULARLY AT THE HUB LEVEL. THIS IS NOT THE ENTIRE CTSA PROGRAM. THIS IS PRIMARILY TALKING ABOUT THE HUB. SO NEXT SLIDE, PLEASE. SO THE CTSA PROGRAM LIVES WITHIN THE NCATS DIVISION OF CLINICAL INNOVATION AND YOU SEE THAT OUR MANDATE IS AROUND INNOVATING CLINICAL AND TRANSLATIONAL SCIENCES. CTSA IS OUR PRIMARY, NOT EXCLUSIVE, BUT PRIMARY PROGRAM WE SUPPORT. AND JUST EMPHASIZE THAT WHILE CLINICAL IS THERE, WE REALLY DO SPAN THE T1-T4 SPACE BUT WITH A RECOGNITION THAT AT THE NIH LEVEL, T4 IS PROBABLY RELATIVELY UNDER REPRESENTED. SINCE WE FEEL IT IS A PRIMARY SPACE FOR ADDRESSING THINGS LIKE HEALTH DISPARITIES, WE WANT TO MAKE SURE THAT WE HAVE SUFFICIENT EMPHASIS IN THAT AREA. NEXT SLIDE, PLEASE. SO THIS JUST GIVES YOU A BROAD OVERVIEW OF THE SCOPE OF THE CTSA PROGRAM WHERE THEY ARE, THE PURPLE STARS ARE THE HUBS, THE RED DOTS ARE PARTNERING INSTITUTIONS AND COLLABORATORS, ASSOCIATED WITH THOSE. YOU SEE THAT IN SOME PLACES WE ARE OFF THE MAINLAND IN PUERTO RICO AND WE EVEN HAVE SOME ACTIVITIES UP IN ALASKA GOING ON. THE GREEN DOTS ARE ASSOCIATED WITH THEINS INSTITUTIONAL DEVELOPMENT NETWORK OR THE IDEA CTRs AND WE HAVE ESTABLISHED INCREASING COLLABORATION COLLABORATIONS TO IN GAUGE THOSE OPERATIONS BECAUSE THEY GIVE US GEOGRAPHIC ACCESS TO UNIQUE POPULATIONS THAT ARE SOMETIMES LIMITING WITHIN THE OVERALL CTSA PROGRAM. NEXT SLIDE, PLEASE. SO THE CTSA PROGRAM FOCUS REALLY REVOLVES AROUND THESE SIX ELEMENTS, INNOVATION IS ALWAYS THE KEY. WE TALK ABOUT MORE TREATMENTS TO MORE PEOPLE, MORE QUICKLY AND I LIKE TO THINK OF IT AS WE REALLY DO THE HEAVY LIFT OF TRYING TO TURN SCIENCE INTO MEDICINE. AND WE WANT TO DO THAT FASTER. THERE HAS BEEN A TREMENDOUS AMOUNT OF FOCUS ON IMPACTFUL PARTNERSHIPS AND COLLABORATIONS THROUGHOUT THE ENTIRE SYSTEM. AGAIN, VERY IMPORTANTLY ADDRESSING HEALTH DISPARITIES BECAUSE WE FEEL THIS DOESN'T ALWAYS NEED A NEW TREATMENT. IT'S FIGURING OUT HOW TO GET ALL THE TREATMENTS WE HAVE TO EVERYONE WHO ACTUALLY NEEDS THEM. WE HAVE SEEN VERY PROMINENTLY IN THE LAST YEAR THAT THE ABILITY TO HAVE A RAPID RESPONSE TO URGENT PUBLIC HEALTH NEEDS. COVID HAS DRIVEN THIS HOME AND THE CTSAs HAVE BEEN INVOLVED IN A LARGE COMPONENT OF THAT NATIONAL RESOURCE IN ORDER TO RAPIDLY MOVE CONCEPTS AND A POTENTIAL THERAPEUTICS FASTER INTO THE CLINICAL SPACE. TRAINING AND CAREER SUPPORT, WE FEEL IS INCREDIBLY IMPORTANT AND THE FIELD OF TRANSLATIONAL SCIENCE, WHICH IS STILL DEVELOPING, WE REALLY WANT TO CONTINUE TO NURTURE THAT FIELD AS MUCH AS POSSIBLE. NEXT SLIDE, PLEASE. SO THIS IS THE CTSA PROGRAM AT A GLANCE. IN FY20, THERE ARE 60CTSA HUBS IN THE PURPLE BOX YOU SEE THAT THE REQUIRED COMPONENT FOR A HUB AWARD IS THE MAIN CTSA GRANT ITSELF, THE UL1 WITH THE REQUIRED INSTITUTIONAL MENTOR CAREER DEVELOPMENT PROGRAM OR THE K PROGRAM, AND THEN AN OPTIONAL INSTITUTIONAL TRAINING PROGRAM, THE T. WE HAVE A NUMBER OF CONSORTIUM-WIDE ACTIVITIES. I'M NOT GOING TO ADDRESS THEM TODAY. AND WE HAVE A NUMBER OF ADDITIONAL PROGRAM FUNDING OPPORTUNITIES INCLUDING OUR COLLABORATIVE INNOVATION AWARDS THAT ALLOW MULTIPLE CTSA INSTITUTIONS COME TOGETHER TO WORK ON A PARTICULAR PROJECT. AND THEN WE HAVE A NUMBER OF SUPPLEMENTS, INCLUDING DIVERSITY AND CAREER RE-ENTRY OPPORTUNITIES. SO THE CTSA PACKAGE YOU'RE GOING TO HEAR ABOUT IS AN INTEGRATED SUITE OF RELATED AND IMPORTANTLY LIMITED COMPETITION INITIATIVES THAT ADDRESS MANY OR IF NOT ALL OF THE CTSA PROGRAM GOALS. THE CURRENT U54 FOA WILL EXPIRE ON JULY 16 AND WE WOULD LIKE TO BE ABLE TO HAVE THIS AVAILABLE COMING ON AFTER THAT. BUT YOU'RE GOING TO HEAR ABOUT THE NEW HUB COMPONENT, UM1, AS OPPOSED TO THE UL1 WE CURRENTLY HAVE. SPECIALIZED INNOVATION PROGRAMS WHAT IS GOING TO BE AN RC2 MECHANISM ALTHOUGH THIS WILL BE PRESENTED TODAY, THIS WILL BE PUBLISHED LATER THAN THE REST OF THE PACKAGE BECAUSE IT WILL BE LIMITED TO UM1 AWARDEES. AND THEN YOU'RE GOING TO HEAR ABOUT A SERIES OF INSTITUTIONAL TRAINING T32 PRE AND POST DOC ACCIDENT, INSTITUTIONAL CAREER DEVELOPMENT AS K12 AND THEN EDUCATION RESOURCE, SHORT TERM RESEARCH EXPERIENCE. SO WHAT I'M GOING TO DO IS TRY TO GIVE YOU SOME HIGHLIGHTS AND THEN GO INTO A LITTLE MORE DETAIL SO ON THE NEXT SLIDE, THE PROPOSED PROGRAM ENHANCEMENTS, I'LL MENTION THESE HAVE BEEN INFORMED BY PUBLIC CTSA AND BROADER SCIENTIFIC COMMUNITY FEEDBACK. SO JUST SOME OF THE HIGHLIGHTS OF THIS. THIS HAS BEEN A LONG TIME COMING. IT'S TAKEN A LOT OF CONVERSATIONS. A LOT OF BACK-AND-FORTH. BUT WE HAVE BEEN ABLE TO SECURE WITH THIS NEW MECHANISM THE INCREASED HUB AWARD PERIOD FROM 5-7 YEARS. IN ADDITION, THE ADVANTAGE WE FEEL IN THIS NEW SERIES OF MECHANISMS IS THAT WE WILL HAVE THE POTENTIAL TO AWARD THE HUB COMPONENT INDEPENDENTLY OF OTHER COMPONENTS. RIGHT NOW, THE U54 IS AN ALL-OR-NONE. YOU EITHER GET EVERYTHING OR YOU GET NOTHING. AND SO WE FEEL THAT THIS OFFERS SOME TREMENDOUS ADVANTAGE TO A LOT OF INSTITUTIONS THAT FIND SOME TIMES THAT ONE COMPONENT REALLY DRAGGED DOWN THEIR SPORT. WE INCREASED EMPHASIS ON PARTNERING AND COLLABORATING PARTICULARLY WITH MINORITY-SERVING INSTITUTIONS TO FOCUS MORE EMPHASIS ON HEALTH DISPARITIES AND TRYING TO INCREASE THE EMPHASIS ON CLINICAL RESEARCH CAPACITIES AND CAPABILITIES OF THOSE PARTNERS THAT COME INTO THE CTSA PROGRAM. WE HAVE DONE A LOT OF THE MODIFICATIONS WITH STREAMLINING APPLICATIONS BOTH PRE AND POST AWARD, BOTH ON THE APPLICANT SIDE AND ON OUR SIDE, WHICH DOES INVOLVE QUITE A BIT OF BACK-AND-FORTH WITH THE INSTITUTIONS THAT WORK THOSE THROUGH. AND WE HAVE ADDED TRAINING AND OTHER FUNDING OPPORTUNITIES AS YOU'LL SEE. NEXT SLIDE. SO WHAT DO WE NOT CHANGE? IT'S BEEN NO ATTEMPT TO CHANGE EITHER THE HOWEVER ALL NUMBER OR THE AWARD SIZE. MODELING AND FORECASTING WE HAVE DONE UNDER THESE NEW MECHANISMS AND PROJECTIONS HAS BEEN WITHA AN EYE TOWARDS MAINTAINING AS MUCH AS POSSIBLE OF BUDGET NEUTRAL APPROACH. SO THE HUBS WILL NOT BE SEEN ANY SIGNIFICANT CHANGE IN THE FUNDING AS THEY ARE CURRENTLY UNDER OUR CURRENT PARADIGM THAT I'LL DESCRIBE LATER ON. THE OVERALL IN INVESTMENTS INCLUDES A HUB, CAREER DEVELOPMENT AND A TRAINING AND EACH INSTITUTION WILL BE LIMITED TO ONE U AWARD, ONE K AWARD AND UP TO ONE EACH OF THE THREE TYPES OF TRAINING. THE INSTITUTION WILL BE OVERSEE THE WHOLE THING AS AN INTEGRATED PROGRAM AND WE HAVE EVERY EXPECTATION THAT EACH HUB WILL HAVE ONE K. AND THE PARTNER COLLABORATOR SELECTION AGAIN AS WE SAID, IS FIRST AND FOREMOST FOR ACHIEVING THE OVERALL APPLICATION OBJECTIVES THAT ARE PROPOSED. NEXT SLIDE. I WANT TO EMPHASIZE A LITTLE BIT -- SORRY, OUR EMPHASIS ON PROGRAM PARTNERSHIPS, THEY REMAIN A CORE ELEMENT. WE THINK THEY ARE INCREDIBLY IMPORTANT AND VIOLATES FOR ACHIEVING THE CTSA GOALS. THEY ALLOW US TO GET A LOT OF ACTIVITY AND PARTICULARLY IN COMMUNITY ENGAGE INDEPENDENT ADDRESSING HEALTH DISPARITIES. THE SELECTION OF THESE PARTNERS AND COLLABORATORS IS CRITICALLY IMPORTANT FOR THE HUB TO BE ABLE TO ACHIEVE THEIR OBJECTIVES AND IT IS CONSIDERED DURING PEER REVIEW, IN PARTICULAR, WE RECOGNIZE THAT NOT ALL HUB PARTNERING INSTITUTIONS NECESSARILY RECEIVE NIH FUNDING. THE INCREASED EMPHASIS PUTTING ON CLINICAL RESEARCH CAPABILITIES, WE HOPE WILL ENCOURAGE INCREASED PARTNERING OVERALL AND WE HAVE AN INCREASED EMPHASIS ON THE INCLUSION OF PARTNERS AND COLLABORATORS TO ADDRESS THE BURDEN OF CONDITIONS DISPROPORTIONATELY WILL EFFECT RURAL MINORITY AND UNDERSERVED POP POLICE STATION WE THINK THIS WILL ENCOURAGE ENHANCED PARTNERING OPTIONS FOR THE INSTITUTIONS. POPULATIONS -- THERE ARE ALL TYPES OF EXAMPLES HERE. NEXT SLIDE. SO HOW DID WE GET HERE? SO WE'VE HAD A WIDE VARIETY SOLICITED INPUT FROM A WIDE VARIETY OF SOURCES. WE DID HAVE A REQUEST FOR INFORMATION, OR RFE THAT WAS PUT OUT IN OCTOBER 2019. WE HAD STAKEHOLDER FEEDBACK SESSIONS OR VIDEOS AND SLIDES AVAILABLE FOR THAT. I SHOULD ADD THAT I CAME ONBOARD INTO THIS PROGRAM IN DECEMBER OF 2017 AND HAD PUT AS AN OBJECTIVE TO VISIT EVERY CTSA IN THE FIRST THREE YEARS OF MY TENURE HERE THROUGH THE FIRST TWO YEARS, I ACTUALLY WAS SUCCESSFULLY THROUGH TWO-THIRDS OF ALL THE CTSA PROGRAM VISITS, UNFORTUNATELY 2020 WAS COVID AND TRAVEL WAS SERIOUSLY CUT BACK. ONE ASPECT IN ADDITION THAT WE HAVE BEEN WORKING TOWARDS FOR THE LAST SEVERAL YEARS IS THE PEER REVIEWERS WE UTILIZE FOR THESE APPLICATIONS AFTER EVERY ROUND AND HAVE A FRANK DISCUSSION WHAT WORKED AND WHAT DIDN'T WORK AND WHAT THEY LIKED AND WHAT THEY THINK WOULD BE BETTER. WHAT WAS PROBLEMATIC FOR THEM IN TERMS OF THE REVIEW. -- SUPREME LINED APPLICATION PROCESS BOTH FROM THE STANDPOINT OF PREPARING THE AWARD, TO REVIEWING THE AWARD APPLICATION AND TO AWARDING THAT APPLICATION AND THEN MY SIGNIFICANT INVOLVEMENT WITH THE CTSA COMMUNITY AS WELL AS STAFF THROUGHOUT HAVE BROUGHT IN QUITE A BIT OF FEEDBACK. ON THE NEXT SLIDE, THIS SHOWS YOU THE TIMELINE. SO WE HAVE ESSENTIALLY BEEN WORKING ON THIS FOR THE LAST THREE FISCAL YEARS, 18, 19 AND 20 IS WHEN THIS WAS INITIATED. THIS GIVES YOU THE TIME LINES. WHAT WE ARE TALKING ABOUT HERE NOW FOR THE CONCEPTS, THE FIRST HUB NEW AWARDS WOULD NOT BE UNTIL FISCAL YEAR 23 AND THEN THE SPECIALIZED INNOVATION PROGRAMS WOULD BE COMING ON IN FY24. WE HOPE TO BE ABLE TO INTRODUCE ADDITIONAL SCHOLAR SLOTS LATER AND THEN BY FY27, WE WOULD ANTICIPATE ALL THE HUBS WOULD BE UNDER THIS NEW FOA. THE C3R2D2 WE SPOKE ABOUT AT LENGTH AND THAT CONCEPT HAD BEEN APPROVED BACK AT THE JANUARY COUNCIL MEETING AND THOSE AWARDS, THE FIRST APPLICATIONS ARE UNDER REVIEW AT THE MOMENT. NEXT SLIDE, PLEASE. SO THE PLANNED MODIFICATIONS YOU'RE GOING TO HEAR ABOUT REALLY CAN BE PUT INTO THREE DISTINCT BUCKETS. ONE WAS DECREASING THE APPLICANT ADMINISTRATIVE BURDEN. WE HEARD THIS LOUD AND CLEAR FROM NEARLY UNIFORM CONSENSUS THAT THE APPLICATION PROCESS IS INCREDIBLY CUMBERSOME AND REPETITIVE AND BECAUSE IT'S AN ALL OR NOTHING FAILURE MEANS YOU GO BACK AND START ALL OVER AGAIN. WE ALSO RECOGNIZED THAT WHILE THERE MAY HAVE BEEN UNINTENDED CONSEQUENCE OF TRYING TO STREAMLINE THINGS IN THE PAST, THERE WAS A GENERAL PERCEPTION THAT THERE WAS A LITTLE BIT OF TOO MUCH OF COOKIE CUTTER FOCUS FROM NCATS IN TERMS OF HOW THE HUBS -- TOO MUCH GUIDANCE A LITTLE TOO MUCH DIRECTION. AND A CALL FOR MORE INCREASING THE ABILITY FOR THE HUBS TO HAVE A GREATER FLEXIBILITY AND IN PARTICULAR TO GIVE THE HUBS MORE OPPORTUNITY TO SPECIALIZE IN AREAS THAT THEY EITHER HAD PARTICULAR ASSETS, PARTICULAR EXPERTISE, OR AREAS THAT THEY WANTED TO PURSUE OVER AND ABOVE. SO RATHER THAN HAVING 68 IDENTICAL HUBS ACROSS THE COUNTRY, WAS TO REALLY HAVE 60 CENTERS OF INNOVATION THAT WERE EACH DOING FUNDAMENTALLY A SET OF THINGS THAT MAKE A CTSA A CTSA BUT ALLOW THE HUBS THE OPTION AND THE OPPORTUNITY TO BE ABLE TO MOVE IN DIRECTIONS THAT THEY FELT WERE REALLY ADVANTAGEOUS TO THEM EITHER BECAUSE OF THEIR LOCAL CONDITIONS OR BECAUSE OF THEIR LOCAL EXPERTISE AND LOCAL INTEREST OR WHATEVER. AND THEN FINALLY THE THIRD WAS, EXPAND THE HUB FUNDING OPTIONS. AS MUCH AS POSSIBLE. NOT SURPRISING COMING FROM THE SCIENTIFIC COMMUNITY THAT WE'D LIKE TO SEE MORE FUNDING OPTIONS. HARD TO ARGUE WITH THAT. SO, I'LL GIVE YOU SOME HIGH-LEVEL ASPECTS ON WHAT THESE LOOK LIKE. THE NEXT SLIDE -- SO THE CURRENT HUB, STRUCTURE IS A U54 MECHANISM. THIS IS ONE GIANT COMBINED UKT APPLICATION. WE HAVE HEARD FROM HUBS THAT SOMETIMES THESE AMOUNT TO UPWARDS OF 2-3,000 PAGES. THEY ARE REVIEWED AND SCORED AS A PACKAGE. THERE IS ONE SINGLE SCORE. SO YOU EITHER LIVE AND DIE BY THAT SCORE AND THE HUB AND CAREER, THE U AND K ARE REQUIRED REQUIRED. THE T OPTIONAL. UNDER THE NEW PROPOSAL THAT WE ARE SUGGESTING IS THE HUB WILL TRANSITION FROM A U54 TO A UM1. ERICA WILL GO INTO MORE DETAILS WITH THIS BUT AT THE TIME WHEN THE CTSAs WERE CREATED BACK IN 2016R.6, THE UM1 DID NOT EXIST. IT WAS CREATED ABOUT A DECADE AGO. SO AROUND THE TIME NCATS WAS BEING CREATEDMENT, THE MM1 WAS BEING CREATED INDEPENDENT OF NCATS AND WE HAVE ABOUT A DECADE OF EXPERIENCE WITH MULTIPLE ICs ACROSS NIH UTILIZING THE U MORE. 1 AND WE REALLY FEEL THE UM1 STRUCTURE IS MORE ALIGNED AND MORE IN SYNCH WITH THE ACTIVITIES OF THE CTSA PROGRAM. SO WHILE WE HAVE DELINKED THE U AND THE K AND THE T, THERE WILL BE CONCURRENT SUBMISSION OF THE HUB WITH CAREER AND TRAINING APPLICATIONS, BUT THESE WILL BE REVIEWED AND SCORED SEPARATELY AND THUS THE HUB CAN BE AWARDED INDEPENDENTLY OF THE Ks AND Ts. BUT WE HAVE EVERY EXPECTATION AND IN ALL OF OUR BUDGETING AND FORECASTING, WE HAVE ASSUMED THAT EACH HUB IS GOING TO HAVE ONE K ASSOCIATED WITH IT. NEXT SLIDE. NOW THE OTHER MAJOR CHANGE WE ARE PROPOSING IS CHANGING THE AWARD CALCULATION. NOW THIS WAS A LITTLE COMPLICATED. SO I'M GOING TO WALK YOU THROUGH THIS. SO THE CURRENT PARADIGM FOR HOW THE AWARD CALCULATION IS MADE IS THE TOTAL NIH FUNDING OF THE APPLICANT AND THE PARTNER OVER THE PREVIOUS YEAR FROM THEIR APPLICATION, BECAUSE THAT'S WHEN WE HAD THE MOST OR THE MOST RELEVANT FULL DATASET AVAILABLE TO US. AND THEN THERE IS -- THAT IS SCALED AS ORIGINALLY SET DOWN WITH 2.5 -- TO THE AWARD IS 2.5% OF THE NIH FUNDING. WITH MINIMUMS AND MAXIMUMS AND THAT IS HOW THIS WAS ORIGINALLY SET UP AND THAT IS HOW THIS IS STILL BEEN MAINTAINED. I'LL TALK IN MORE DETAIL IN A MINUTE. THE PROPOSED IS A ROLLING AVERAGE OF THE PREVIOUS FIVE YEARS OF TOTAL NIH FUNDING FOR THE APPLICANT PLUS THE FIVE-YEAR ROLLING AVERAGE OF THE NIH CLINICAL RESEARCH FUNDING OF ALL OF THEIR PARTNERS. NOW THE REASON WE WENT TO A ROLLING FIVE-YEAR AVERAGE IS WE FIND OUT FROM A LOT OF BUDGET MODELING THAT THIS SMOOTHS OUT A LOT OF FUNDING CYCLES FOR MANY INSTITUTIONS AND SO THAT OVER ANY ADJACENT FIVE-YEAR ROLLING AVERAGE THERE IS VERY LITTLE CHANGE IN THE RELATIVE STANDING OF THOSE INSTITUTIONS. EMPHASIS IS ON CLINICAL RESEARCH. WE ARE USING JUST THE NIH CLINICAL RESEARCH FUNDING ALL OF THESE FIGURES ARE PUBLICLY AVAILABLE SO INSTITUTIONS WILL BE ABLE TO CALCULATE WHAT THERE IS. AND THEN ONCE YOU ARE SET IN THAT OVERALL AVERAGE, WE HAVE FOUR GENERAL CATEGORIES FOR FUNDING REQUESTS THAT WILL BE SET BASED ON OUR ALLOWABLE BUDGET. THE MODELING AND THE FORECASTING THAT WE HAVE DONE HAS ALL BEEN -- HAS ALL BEEN DONE WITH THE INTENT OF A FUNDING NEUTRAL OUTCOME FOR THE HUB SO THE AMOUNT OF MONEY YOU'RE GETTING UNDER THE CURRENT PARADIGM, YOU WILL GET COMPARABLE MONEY UNDER THE NEW PARADIGM. ON THE NEXT SLIDE, I WANT TO TRY TO GO THROUGH AND SORT OF TELL YOU WHY WE HAVE COME ABOUT THIS. SO NCATS BEGAN IN 2012. WE ARE IN 2021 AT THIS POINT IN TIME. SO THE OVERALL NIH BUDGET HAS OUTPACED THE CTSA BUDGET OVER THIS PAST 10 YEARS. SUCH THAT WHILE THE NIH BUDGET HAS GROWN AT 39% OVERALL, THE CTSA BUDGET HAS ONLY GROWN BY 20%, ABOUT HALF THE RATE THAT THE NIH BUDGET IS GROWING. AND WHILE THERE WASN'T ANYTHING DONE BETWEEN THE ORIGINAL 2006 WHEN PRIOR TO NCATS, WHEN THE CTSAs WAS SET UP IN NCRR, THE BUDGET WAS NOT SPLIT OUT SO IT'S HARD TO GIVE FIGURES THERE IN THIS REGARD. WHETHER IT CAME TO 2012, THEY RECOGNIZED THERE WAS SOME DISPARITY GROWING BECAUSE OF THE SIZE OF THE BUDGET RELATIVE TO THE CTSA BUDGET MAINTAINING THAT TIE OF 2.5%. SO BY 2014, TO ADDRESS THAT, THIS WAS WHERE THE MAXIMUM CAP WAS PLACED ON CTSA BUDGETS. SO THE TOTAL COST WAS INITIAL NE2014, SET AT A MAX NUMB OF 10 MILLION DOLLARS EVENLY THOUGH THERE WERE MANY INSTITUTIONS AS A RESULT OF THE CTSA TIE SHOULD HAVE RECEIVED MORE THAN 10 MILLION. IT WAS RECOGNIZED AFTER THIS WAS DONE THAT BECAUSE UPON DISTINCTION NECESSARY INDIRECT COST RATES, IT WAS A PENALIZING INSTITUTIONS THAT HIGHER INDIRECT COST RATES SHIFTED TO 7.5 MILLION DIRECT COST, WHICH KEEPS IT ROUGHLY COMPARABLE. THAT WHERE WE ARE OPERATING R WE ARE AT NOW WITH THIS SHRINKING PORTION OF THE CTSA RELATIVE TO THE NIH BUDGET, IN 2020, WE ACTUALLY HAVE 15 HUBS THAT ARE AT THE MAX CAP THEY CAN RECEIVE OR ABOUT 25% OF THE ENTIRE CTSA PROGRAM. AND WILL OUR MODELING SUGGESTS THAT AT THIS CURRENT RATE OF GROWTH, WHICH RELYING ON PROFESSIONAL JUDGMENT FROM THE BUDGET PEOPLE, OVER THE NEXT FIVE YEARS, WE THEY WANT THAT NUMBER AT THE MAX IS GOING TO INCREASE BY 50%. AND SO THE CURRENT FUNDING OF THE 2.5% TIE NOT ONLY IS NOT SUSTAINABLE BUT IT IS ACTUALLY BECOMING LESS AND LESS RELEVANT FOR A GREATER NUMBER OF CTSA HUBS IT'S JUST -- EVERYONE IS GRADUALLY JUST MIGRATING TO THE MAX. SO THE BOTTOM LINE IS THAT THE CURRENT TIE, THE 2.5% TIE IS SIMPLY NOT SUSTAINABLE OVER THE LONG TERM AND THE ONLY WAY WE CAN ADDRESS THIS TO KEEP THE TIE AS IT IS, IS TO DO ONE OF TWO THINGS. WE EITHER FUND FEWER HUBS, WHICH WE DON'T WANT TO DO, OR WE NEED TO ACTUALLY LOWER THE MAXIMUM CAP, WHICH WE ALSO DO NOT WANT TO DO. SO THAT'S WHY WE ARE PROPOSING A DIFFERENT FUNDING PARADIGM. NEXT SLIDE, PLEASE. SO THE OTHER ASPECT I WANT TO TOUCH ON IS THAT WE ARE REALLY TRYING TO STRENGTHEN THE CLINICAL RESEARCH CAPABILITIES HERE. AND WE WANT TO EMPHASIZE THE CLINICAL RESEARCH FUNDING OF THE PARTNERING INSTITUTIONS, PARTICULARLY BECAUSE WE FEEL THAT THIS IS REALLY WHERE A LOT OF THE FOCUS OF THE CTSA, MANY OF THE PROGRAM GOALS SUCH AS ADDRESSING HEALTH DISPARITIES, ENHANCE COMMUNITY ENGAGEMENT TO MAKE THE APPLICANTS MUCH MORE COMPETITIVE. EXPANDING THE CLINICAL, NATIONAL CLINICAL RESEARCH WE FEEL HAS BEEN TREMENDOUSLY PRODUCTIVE IN TERMS OF OUR INITIALLY PRIOR TO COVID, THE OPIOID RESPONSE, WHICH ALLOWED THE CTSAs TO TAKE ON THE PAIN EFFECTIVENESS RESEARCH NETWORK AND IN TERMS OF COVID RESPONSES, THE CONVALESCENT PLASMA TRIALS WE HAVE UNDERTAKEN AS WELL AS ACTIVE 1 AND ACTIVE 6, 1/3 OF ALL THE ACTIVE PROGRAMS, HAS REALLY EMPHASIZED THE NATIONAL CAPABILITY OF THE OVERALL CTSA PROGRAM. IMPORTANTLY, WE WANT TO BE ABLE TO STABILIZE AND STANDARDIZE BUDGET AND PROJECTIONS AS MUCH AS POSSIBLE SO WE ARE NOT FORCED INTO THE POSITION OF HAVING TO ENGAGE WHEN SOME DRACONIAN MEASURE, SUCH AS MENTIONED EARLIER, REDUCING THE NUMBER OF HUBS OR LOWERING THE MAX CAP. NEXT SLIDE, PLEASE. SO JUST TO HIGHLIGHT WHAT WE HAVE COME OUT OF THIS. IF YOU LOOK IN THE TOP TABLE, THE CURRENT CTSA PROGRAM FUNDING HAS ESSENTIALLY NO FLEXIBILITY. THE APPLICATIONS, INDIVIDUAL SCORES ARE PROVIDED FOR EACH, THERE IS AN OVERALL SCORE THAT IS NOT THE AVERAGE OF THOSE SCORES BUT RATHER AN ASSESSMENT OF THE INTEGRATION OF THE THREE. SO IF YOU HAVE A U SCORE AND K SCORE IN THE FUNDABLE RANGE AND OVERALL SCORE IN THE FUNDABLE RANGE, YOU GET FUNDED. BUT YOU COULD HAVE A VERY GOOD U BUT THE K OR THE T MAY BE SUFFICIENTLY TO DRAG DOWN THE OVERALL U54 SCORE AND THEN THERE IS NO FUNDING. THE ENTIRE PACKAGE MUST BE RESUBMITTED. UNDER OUR PROPOSED CTSA FUNDING, BECAUSE THE U AND THE K AND Ts WILL BE REVIEWED SEPARATELY, A FUNDABLE -- A U SCORE IN THE FUNDABLE RANGE IIRREGARDLESS OF THE K OR T, WILL GET FUNDED. SO THE FUNDING OF THE U, WHICH IS THE MAJOR COMPONENT OF THE OVERALL CTSA AWARD PACKAGE, CAN BE FUNDED AND THE KS AND Ts MAY BE RESUBMITTED AT A LATER TIME. NEXT SLIDE, PLEASE. SO AS I DESCRIBED WHAT WE ARE TALKING ABOUT TODAY IS THE HUB OPPORTUNITIES ALL WITHIN THE BOX HERE. THE HUB OPERATIONS WITH THE UM1, YOU'LL HEAR ABOUT THE SPECIALIZED INNOVATION PROGRAM. THE SMALL GRANTS AWARDS IS RL3 WE ALREADY CONSTITUTEDDED SPECIFICALLY FOR THE HUBS. THE CAREER DEVELOPMENT IS JUST CONVERTING THE KL2 TO A K12 AND THEN THE TRAINING GRANTS SPLITTING THE TL1s INTO A T32, PRE AND POST AND THEN THE R25. AND YOU SEE IN RED ALL THE NEW OPPORTUNITIES THAT ARE BEING OFFERED. BELOW WE HAVE THE CCIAs OR COLLABORATIVE INNOVATION AWARDS FOR MULTIPLE CTSAs AND THEN THE CONSORTIUM-WIDE RESOURCE CENTERS HELP US TO SPAN THE ENTIRE BREATH OF THE TRANSLATION SPACE. NEXT SLIDE, PLEASE. SO HOW IS THIS APPLICATION SUBMISSION? WHAT ARE THE CHANGES FOR THE HUB? RIGHT NOW AS YOU SEE ON THE LEFT-HAND SIDE, THE TWO REQUIRED COMPONENTS WOULD BE OPTIONAL AND THERE IS ONE OVERALL IMPACT SCORE. NOW IF YOU CLICK ONCE -- THANK YOU. YOU'LL SEE THAT THE CTSA HUB GRANT BECOMES A CTSA HUB GRANT TO MEDICAL RESEARCH INSTITUTIONS OR THE UM1. THE NEXT -- CLICK AGAIN. THE KL2 ESSENTIALLY JUST BECOMES A SEPARATE SO WE ARE TALKING ABOUT EXACTLY PRETTY MUCH WHAT IS IN THE KL2 APPLICATION RIGHT NOW WITH AN ADDITIONAL COVER SHEET AND THEN THE OPTIONAL PIECE IS UP TO THE INDIVIDUAL INSTITUTIONS TO GO FROM ONE, ALL THREE OR THEY CAN STAGE THEM IN DIFFERENT TIMES AFTER THE AWARD OF THE UM1 BUT IT WOULD BE LIMITED TO UM1 RECIPIENTS. NEXT SLIDE, PLEASE. SO I WANTED TO GIVE YOU SOME SENSE. SO THE CURRENT OR LENGTH AND COMPLEXITY OF THE CURRENT AND PROPOSED HUB AWARD, THIS IS WHAT THE UL1 APPLICATION LOOKS LIKE AND YOU'LL SEE THE REASON FOR THE DIFFERENT COLOR ELEMENTS. ONE OF THE PROBLEMS WITH THIS U54 IS BECAUSE OF THE DIFFERENT SEGMENTS, THERE IS A LOT OF REPETITION THAT IS REPEATING THE SAME THING OVER AND OVER, WHICH ACTUALLY DETRACTS FROM THE ABILITY TO ACTUALLY EXPLAIN WHAT YOU'RE DOING. NOW IF YOU CLICK ONE MORE TIME, WHAT YOU SEE IS THAT THE UM1 RETAINS ALL OF THOSE ORIGINAL ELEMENTS, THE COLOR-CODING IS TO RELATE THAT. BUT WE JUST COMBINED THEM IN DIFFERENT WAYS AND IT STREAMLINES THE GRANT PROCESS. SO ONE MORE CLICK. SO UNDER THE UL1, IT'S HIGHLY REPETITIVE AND THE REVIEWERS FIND THIS VERY TROUBLESOME TO GO BACK-AND-FORTH LOOKING AND THEY SEE THE SAME THING REPEAT OVER AND OVER. THE UM1 IS A STREAMLINED STRUCTURE, LESS REPETITION, ALTHOUGH THE PAGE NUMBERS ARE SHORTER, THEY HAVE MORE OPPORTUNITY TO PROVIDE DETAILED INFORMATION ON WHAT THEY WANT TO TALK ABOUT BECAUSE THEY ARE NOT REPEATING THE SAME THINGS OVER AND OVER AGAIN. NEXT SLIDE. SO, AFTER OUR DISCUSSION CTSA PROGRAM CONCEPTS, THE UM1 WILL BE DISCUSSED OR PRESENTED BY ERICA. THE SLIGHT CHANGE, SPECIALIZED INNOVATION PROGRAM, PABLO IS ACTUALLY AT THE MOMENT AT THE HOSPITAL WITH HIS WIFE WHO IS DELIVERING A BABY TODAY. SO HE WAS NOT AVAILABLE. AND THEN THE CAREER AND TRAINING WILL BE PRESENTED BY MERCEDES, JOAN AND JAMIE. AND I THINK THAT IS IT. >> THANK YOU, MIKE. SINCE YOU DON'T HAVE A CONCEPT CLEARANCE, WE CAN MOVE ON TO THE CONCEPT CLEARANCE FOR THE UM1 AND WE'LL CIRCLE BACK TO A LIST OF QUESTIONS THAT ARE IN THE CHAT NOW. SO ANDREW AND GEORGE HOLD OFF AND HOLD YOUR QUESTIONS JUST A LITTLE BIT LONGER. WE NEED TO GET THROUGH THE CONCEPT CLEARANCE FIRST AND THEN HAVE THE DISCUSSION. SO ERICA PLEASE TAKE IT AWAY. >> GREAT THANK YOU VERY MUCH, JONI. CAN EVERYONE HEAR ME? >> YES. >> THIS IS A NEW CONCEPT PROPOSED TO SUPPORT THE CLINICAL AND TRANSLATIONAL SCIENCE AWARD. NEXT SLIDE. THE DEVELOPMENT AND IMPLEMENTATION OF CLINICAL INTERVENTIONS IS A COMPLEXITIERATIVE AND TIME CONSUMING PROCESS THAT TAKES YEARS BEFORE DISCOVERIES IN BIOMEDICAL RESEARCH RESULT IN HEALTH BENEFITS FOR PATIENTS AND COMMUNITIES. WE PROPOSE THIS CONCEPT TO SUPPORT INTEGRATED RESEARCH FOR TRAINING ENVIRONMENT FOR CLINICAL AND TRANSLATIONAL SCIENCE. NEXT SLIDE. THIS CONCEPT IS FOCUSED ON REALIZING THE OBJECTIVES IN AREAS OF EMPHASIS OF THE CTSA PROGRAM YOU JUST HEARD FROM MIKE EARLIER. A COUPLE OF POINTS TO EMPHASIZE HERE. THESE FOCUS AREAS DESCRIBE WHAT THE CTSAs ARE DOING TO ACHIEVE THE OVERARCHING GOAL OF THE PROGRAM WHICH IS TO IMPROVE THE TRANSLATIONAL RESEARCH PROCESS, TO BRING MORE TREATMENTS TO MORE PATIENTS MORE QUICKLY. THE CTSAs ARE A NATIONAL RESOURCE FOR THE RAPID RESPONSE TO URGENT, PUBLIC HEALTH NEEDS EMPHASIZED BY HOW THE CTSA PROGRAM HAS RESPONDED TO THE CHANGE IN CLINICAL RESEARCH ECOSYSTEM AND THE WORLD AS THE PROGRAM HAS MATURED. NEXT SLIDE, PLEASE. IN PLANNING FOR THE NEXT FUNDING OPPORTUNITY ANNOUNCEMENT, WE REALIZE VERY HEAVILY ON THE FEEDBACK FROM OUR STAKEHOLDERS. THE REQUEST FOR INFORMATION RESPONSES INDICATED THAT THERE WERE SEVERAL AREAS THAT NEEDED TO BE ADDRESSED. WE NEED TO SIMPLIFY THE FUNDING OPPORTUNITY ANNOUNCEMENTS. WE NEED TO CONSIDER A DIFFERENT FORMAT FOR THESE COMPLEX APPLICATIONS AND ELIMINATE THE REDUNDANCY IN THE APPLICATION. WE NEED TO FIND A WAY TO FACILITATE A SIGNING AND OVERALL SCORE TO THE HUB, CAREER DEVELOPMENT AND TRAINING COMPONENTS. WE NEED TO REMOVE THE CAREER DEVELOPMENT AND TRAINING APPLICATIONS AND REVIEW SEPARATELY. WE NEED TO SEPARATE THE AWARD FUNDING CYCLES FOR THE HUB, CAREER DEVELOPMENT AND TRAINING AND WE NEED TO ALIGN THE CAREER DEVELOPMENT AND TRAINING AWARDS WITH THE ACADEMIC CALENDAR. THESE CHALLENGES ARE ALL ADMINISTRATIVE IN NATURE WHICH CALLS FOR ADMINISTRATIVE SOLUTIONS. ALWAYS KEEPING IN MIND THE ULTIMATE GOAL IS ENHANCING THE CTSA PROGRAM. AND WE ARE PROPOSING TO RESPOND BY DECREASING THE APPLICANT'S ADMINISTRATIVE BURDEN BY SIMPLIFYING THE APPLICATION AND BUDGET. PAYING ATTENTION TO HOW TO ENHANCE THE REVIEW QUALITY. PAYING ATTENTION TO HOW WE STREAMLINE AWARD ACTIONS. AND HOW ARE WE DOING THIS? PLEASE CLICK. BEE MOVING AWAY FROM THE CURRENT U54 MECHANISM COMBINES THE HUB, CAREER DEVELOPMENT AND OPTIONAL TRAINING COMPONENT AND LEVERAGING THE UM1 MECHANISM. I WANT TO PAUSE TO EXPLAIN THIS MECHANISM. THIS REMAINS A COOPERATIVE AGREEMENT MECHANISM TO WHICH PROGRAM STAFF WILL HAVE SUBSTANTIAL INVOLVEMENT. IT IS FOR RESEARCH PROJECTS WITH COMPLEX STRETCHES. THIS PERFECTLY-DESCRIBED HUB AWARD. THE MECHANISM CAME INTO EXISTENCE IN 2011 AND HAS BEEN USED WIDELY ACROSS THE NIH FOR CLINICAL TRIAL NETWORKS AND OTHER CONSORTIUM NETWORKS. THERE ARE SEVERAL ADMINISTRATIVE BENEFITS TO THIS MECHANISM. APPLICATIONS WILL BE SHORTER, LESS REPETITIVE, MORE ORGANIZED AND HAVE A SINGLE BUDGET INSTEAD OF INDIVIDUAL BUDGETS FOR THE ACTIVITIES. THE HUB, CAREER DEVELOPMENT AND OPTIONAL TRAINING COMPONENTS ARE ABLE TO BE SEPARATE RESULTING IN INDEPENDENT SCORES, REVIEWS AND BE ABLE TO BE CONSIDERED SEPARATELY FOR FUNDING. NO MORE WILL YOU HAVE ONE COMPONENT BRINGING DOWN THE SIGNIFICANCE OF ANOTHER COMPONENT. THAT IS THE HUB SCORE WILL NOT BE AFFECTED BY CAREER DEVELOPMENT AWARD AND VICE VERSA. AS IS THE CASE WITH OUR CURRENT OFFERING. THIS WILL FACILITATE MORE ROBUST AND REPRODUCIBLE REVIEWS HAVING SEPARATE REVIEW PANELS ON THE INDIVIDUAL COMPONENT. AND FINALLY THE AWARD ACTIONS CAN BE STREAMLINED AS WE WILL NOT HAVE TO WAIT TO SEPARATE THE HUB APPLICATION INTO THE INDIVIDUAL COMPONENTS AND MAKE ADJUSTMENTS. AGAIN, ALL OF THESE ADMINISTRATIVE ENHANCEMENTS ARE TO SUPPORT ENHANCING THE CTSA PROGRAM WITH THE PURPOSE OF REMOVING OBSTACLES AND BOTTLENECKS TO CONDUCTING THE SCIENCE. NEXT SLIDE, PLEASE. WE ALSO HEARD FROM OUR STAKEHOLDERS THAT THERE WAS A NEED TO INCREASE THE FLEXIBILITY AND DIVERSITY ACROSS THE HUBS SO THEY CAN LEVERAGE THEIR STRENGTHS AND DRIVE INNOVATION. TO SIMPLIFY AND DECREASE THE NUMBER OF REQUIRED CORES, TO CONSIDER REORGANIZATION OF COMPONENTS AND ALLOW AWARDEES AND HUBS TO SPECIALIZE. WE RESPONDED BY REQUIRING FEWER ELEMENTS, ACCOMPLISHED USING ADMINISTRATIVE ENHANCEMENTS IN THE PROPOSED UM1, ALLOWING HUBS TO BE ABLE TO EMPHASIZE UNIQUE QUALITIES IN A HUB AND CREATING A HUB-SPECIFIC RESEARCH PROJECT. THIS IS WHERE SOME OF THE SCIENTIFIC ENHANCEMENTS COME TO THE FOREFRONT. NEXT CLICK, PLEASE. WE WANT TO EMPHASIZE THAT THE ACTIVITIES THAT MAKE A CTSA ARE A CTSA, ARE RETAINED. THE HUB'S ACTIVITIES WILL BE REORGANIZED AND GROUPED TO REFLECT THE BOOTS ON THE GROUND IMPLEMENTATION. NO ACTIVITIES WILL BE CUT OUT AND THE KEY ACTIVITIES ARE RETAINED. I'LL GO INTO THIS IN MORE DETAIL IN THE NEXT SLIDE. UNDER THE CONCEPT, THE HUBS WILL BE ABLE TO BALANCE THEIR EMPHASIS WITHIN THE HUB'S ACTIVITIES MORE EASILY UNDER A SINGLE BUDGET AND THIS IS EXPECTED TO RESULT IN THE HUB'S MORE EASILY BEING ABLE TO FOCUS ON AREAS IMPORTANT FOR THE HUB'S STAKEHOLDERS AND COMMUNITY. IT IS THESE ENHANCEMENTS TO ALLOW THE HUBS TO SHOWCASE STRENGTHS AND CAPABILITIES AND WE THINK THIS WILL CONTRIBUTE TO STRENGTHENING THE CONSORTIUM AS A WHOLE AND ADVANCING CLINICAL AND TRANSLATIONAL SCIENCE. AND FINALLY, THE DISCRETE RESEARCH PROJECT IS EXPECTED TO ADDRESS A SIGNIFICANT ROAD BLOCK IN CLINICAL AND TRANSLATIONAL SCIENCE THAT WILL INCREASE THE OVERALL EFFICIENCY OR EFFECTIVENESS OF TRANSLATION. CONSISTENT WITH THE NCATS MISSION TO CATALYZE TRANSLATION OF DISCOVERIES, THE RESEARCH PROJECT IS EXPECTED TO FOCUS ON CLINICAL AND FRANCEALATIONAL SCIENCE RATHER THAN BASIC DISCOVERY RESEARCH. SUCH RESEARCH PROJECTS SHOULD NOT ONLY ADDRESS A TRANSLATIONAL RESEARCH QUESTION IN A PARTICULAR DISEASE OR INTERVENTION, DEVELOPMENT, DISSEMINATION CONTEXT, BUT ALSO PROVIDE GENERALIZABLE, CLINICAL AND TRANSLATIONAL SCIENCE, INNOVATIONS OR INSIGHTS THAT CAN BE APPLIED TO OTHER TRANSLATIONAL RESEARCH PROJECTS. AND THEREFORE INCREASE THE OVERALL EFFICIENCY OR EFFECTIVENESS OF TRANSLATION. THIS NEW RESEARCH PROJECT PROVIDES AN OPPORTUNITY FOR HUBS TO SPECIALIZE AND FURTHER BUILD INNOVATIONS AND SPACES WHERE THEY EXCELL AND IT IN TURN INCREASES FLEXIBILITY AND DIVERSITY ACROSS HUBS TO LEVERAGE THEIR UNIQUE STRENGTHS AND TO DRIVE INNOVATION. NEXT SLIDE. SO WHAT'S DEPICTED IS THE TYPES OF ACTIVITIES SUPPORTED UNDER THE CURRENT HUB OFFERINGS AND THE PROPOSED HUB OFFERING. THIS IS THE POINT THAT ALL ACTIVITIES THAT MAKE THE BASE OF A CTSA, ADMINISTRATION, SUPPORT FOR THE NETWORK, LEVERAGING HUB LIAISONS TEAMS, ENGAGING COMMUNITIES IN THE RESEARCH PROCESS, SUPPORTING AND ENCOURAGING TEAM SCIENCE, DEVELOPING A CLINICAL AND TRANSLATIONAL SCIENCE WORKFORCE, SUPPORTING INNOVATING INFORMATICS, PROVIDING BIOSTATISTICS, EPIDEMIOLOGY AND RESEARCH DESIGN OR BIRD, REGULATORY KNOWLEDGE AND SUPPORT AND SUPPORTING THE PILOT PROGRAM ARE RETAINED. BASED ON THE FEEDBACK WE RECEIVED FROM STAKEHOLDERS, THE ACTIVITIES ARE REORGANIZED UNDER STRATEGIC MANAGEMENT, COMMUNITY ENGAGEMENT AND WORKFORCE DEVELOPMENT, CLINICAL AND TRANSLATIONAL SCIENCE RESOURCES AND PILOTS. ONE THING THAT WILL BE EMPHASIZED UNDER STRATEGIC MANAGEMENT IS THE RELATION THAT CTSAs WORK AS A CONSORTIUM AND INVESTMENT IN LOCAL CAPACITY AND LOCAL INNOVATIONS MAY FURTHER ENHANCE CAPACITY AT A DIFFERENT CTSA SHARED AND DISSEMINATED. THESE ACTIVITIES WILL BE ENCOURAGED UNDER STRATEGIC MANAGEMENT. THE OPTIONAL COURSE WILL BE SUPPORTED IN A SEPARATE OFFERING WITH AN EMPHASIZE OF SUPPORTING LOCAL INNOVATIONS WITHIN THE HUB AND THE RESEARCH PROJECT IS A REQUIRED ACTIVITY WITH THE GOAL OF ADDRESSING A SIGNIFICANT ROAD BLOCK IN CLINICAL AND TRANSLATIONAL SCIENCE. NEXT SLIDE, PLEASE. YOU CAN PULL OFF OF IT, THANK YOU. THIS IS MORE DETAILED DEPICTING HOW THE FUNDING OPPORTUNITIES ORGANIZED UNDER THE CURRENT FUNDING OPPORTUNITY ANNOUNCEMENT. THE UL1 AND THE PROPOSED FUNDING OPPORTUNITY ANNOUNCEMENT USING THE UM1 MECHANISM. AGAIN, THE SECTIONS OF THE OLD FUNDING OPPORTUNITY ANNOUNCEMENT ARE A MAP TO THE NEW FUNDING OPPORTUNITY ANNOUNCEMENT USING COLORS. THOSE CHALLENGING TO SEE THE DETAILS UNDER EACH SECTION OF THE UL1 THERE IS INFORMATION THAT IS REPEATED UNDER EACH COMPONENT, INCLUDING COVER PAGE, PERFORMANCE SITES, KEY PERSONNEL, HUMAN SUBJECTS, LETTERS OF SUPPORT, RESOURCE SHARING PLANS, THEN THE RESEARCH STRATEGY PLAN AND BUDGET. THIS IS REPEATED OVER AND OVER AGAIN. WITH THE UM1, THE INFORMATION THAT IS REPETITIVE AND PROVIDED IN EVERY SECTION OF THE UL1 IS PROVIDED IN A SINGLE-TIME IN THE OVERVIEW. AND EACH SECTION IS FOCUSED ON THE RESEARCH STRATEGY AND RESEARCH PLAN. THE UL1 HAS A STREAMLINE STRUCTURE WITH LESS PAGES MAKING IT EASIER FOR REVIEWERS TO FIND INFORMATION AND FOCUS ON REVIEWING THE SCIENCE. WE ARE AWARE OF CONCERNS THAT THE NEW FOA WILL REQUIRE EXTENSIVE CHANGES IN CURRENT CTSAs AS THE FOA HAS BEEN USED TO STRUCTURE ACTIVITIES AT THE APPLICANT INSTITUTIONS. I WANT TO RESTATE THAT THE ACTIVITIES IN THE CURRENT FOA ARE RETAINED IN THE NEW FOA IN THAT THE UM1 MECHANISMS WOULD LEVERAGE FOR ADMINISTRATIVE ENHANCEMENTS AND WE DON'T EXPECT THE CTSAs INDIVIDUAL TO SIGNIFICANTLY OR NEARLY AT ALL RESTRUCTURE OR REORGANIZE WHERE ACTIVITY TO BE RESPONSIVE TO THIS NEW FOA. NEXT SLIDE, PLEASE. SO IN SUMMARY, THE PROPOSED ENHANCEMENTS TO THE CTSA PROGRAM IS BASED ON FEEDBACK, DECREASING APPLICANT AND ADMINISTRATIVE BURDEN AND INCREASING FLEXIBILITY AND SPECIALIZATION OPPORTUNITIES, INCREASING HUB FLEXIBILITY AND HUB SPECIALIZATION OPPORTUNITIES, INTRODUCING CLINAL AND TRANSLATIONAL SCIENCE RESEARCH PROJECTS AND WE HOPE THAT THIS CONCEPT WILL DEMONSTRATE THAT THIS IS BUILDING ON THE EXISTING CTSA PROGRAM AND NURTURING INNOVATIONS IN CLINICAL AND TRANSLATIONAL SCIENCE. NEXT SLIDE. WITH THAT, I'LL TURN IT BACK OVER TO COUNCIL MEMBERS FOR THEIR COMMENTS AND QUESTIONS. THANK YOU. >> THANK YOU. WE HAVE PAULE HARRIS, BECKY JACKSON AND PAULA AS DISCUSSANTS. SO I'D LIKE TO HAVE THEM HAVE AN OPPORTUNITY TO DIME IN AND THEN WE'LL TURN IT OVER TO THE QUESTIONS IN ORDER THEY WERE COMING IN. SO PAULE HARRIS, BECKY JACKSON OR PAULASHIRE MAN, WHICH ONE OF YOU WOULD LIKE TO GO FIRST? >> I GOT TO GO FIRST LAST TIME. LET ME GIVE SOMEBODY ELSE AN OPPORTUNITY. >> THANK YOU, PAULE. PAULA, WOULD YOU LIKE TO CHIME IN? >> THANK YOU FOR THAT OVERVIEW. I DO AGREE A LOT OF THE COMPONENTS WE ARE TALKING ABOUT ARE VERY ADVANTAGEOUS. THE R. OUR LAST CTSA APPLICATION WAS OVER 1800 PAGES. I WILL SAY A LOT OF REDUNDANCY ARE TAKEN CARE OF WITH THE OVERVIEW WHERE WE HAD TO PUT THE SAME DOCUMENT IN OVER AND OVER FOR EACH CORE. I THINK THE THING THAT IS GOING TO CAUSE PERHAPS THE MOST CONTROVERSY OR THE MOST -- IS THE BUDGET. THE IDEA THAT IT WOULD JUST BE CLINICAL FUNDERS, A LOT OF CTSAs HAVE RELATIONSHIPS WITH MORE BASIC SCIENCE OR TRANSLATIONAL SCIENCE INSTITUTES THAT HAVE KIND OF A SEAMLESS THING ACROSS THE TRANSLATIONAL SPECTRUM. I WILL SAY, AS BEING A MEMBER FROM A CTSA THAT ON THE SMALLER END, A LOT OF THE PROGRAMS DON'T SCALE. SO IN OTHER WORDS, YOU DO HAVE THIS WIDE RANGE OF CTSA BUDGETS YET A LOT OF DIFFERENT ASPECTS AND SO AS YOU POINTED OUT THE UL1 REALLY DOESN'T DECREASE ANYTHING FROM THE UL1 SO THAT BOTTOM END OF THE BUDGET, WE REALLY HAVE A HARD TIME FITTING EVERYTHING IN. I DO LIKE THE IDEA AND I THINK YOU'RE VERY CORRECT IN YOUR ASSERTION, ESPECIALLY GIVEN THE PANDEMIC, THAT CTSAs HAVE BEEN VERY INSTRUMENTAL IN REACHING DISADVANTAGED POPULATIONS AND THE IDEA THAT OUR PARTNERING WITH LIKE FOR INSTANCE WE PARTNER WITH THE METROPOLITAN HEALTH DISTRICT. THEY DON'T GET ANY NIH GRANTS, HOWEVER, THEY REACH HARD TO REACH POPULATIONS AS DO WE WITH OUR COMMUNITY ENGAGEMENT. SO ONE OF THE THINGS THAT I THINK NEEDS TO BE UNDER CONSIDERATION IS THAT THE NIH, MANY OF THE ORGANIZATIONS, THE CTSAs PARTNER WITH, THE MOST CRITICAL FOR DIVERSITY, EQUITY AND INCLUSION, DO NOT HAVE NIH BUDGETS AND ARE NOT INCLUDED IN THE OVERALL UM1. SO CONSIDERING THOSE TYPES OF FACTORS, THE ORGANIZATIONS THAT WE PARTNER WITH THAT HAVE THE MOST NEED HAVE NO NIH BUDGET. AND THAT IS REALLY ESPECIALLY AS THE PANDEMIC HAS SHOWN, THESE ARE THE POPULATIONS THAT WE NEED TO BE ABLE TO REACH. SO I THINK CONSIDERATIONS AND MAKING SURE THAT THAT BOTTOM-LEVEL FOR THE CTSAs DOESN'T GO FURTHER, BECAUSE EVEN THOUGH YOU HAVE INCLUDED EVERYTHING, THERE IS YET ANOTHER THING ADDED. THE PROJECT, WHICH WILL ALSO TAKE FUNDS, WHICH I'M SURE IS GREAT AND I'M SURE THAT WE CAN COME UP WITH MANY UNIQUE IDEAS THAT WILL BE WONDERFUL AND CAN ADVANCE TRANSLATIONAL SCIENCE BUT IT'S STILL ONE MORE THING WE HAVE TO ADD TO THAT UM1 CORE THAT GETS VERY, VERY DIFFICULT AT THE BOTTOM END OF THE FUNDING. I LIKE THE IDEA OF GOING TO SEVEN YEARS. IT SEEMS AS THOUGH WE JUST GOT ONE FUNDED AND WE HAVE TO GO BACK IN. AND SOME OF THESE PROGRAMS TAKE TIME TO MATURE. THE IDEA THAT YOU CAN HAVE A UM1 AND THEN THE TRAINING PROGRAMS ARE THEN CONTINGENT UPON HAVING A UM1, I DO THINK SIMPLIFIES IT, HOWEVER I THINK THE TRAINING PROGRAMS ARE VERY MUCH LINKED TO THE UM1 AND SO WITHIN THOSE TRAINING PROGRAMS WHETHER THE K OR Ts, THAT THEN THERE HAS TO BE SOMETHING THAT GIVES THE FLAVOR OF WHAT THE UM1 IS. FOR EXAMPLE, WE ARE SENDING ANTONIO, WE HAVE A HISPANIC POPULATION AND THAT REALLY INFORMS MUCH OF WHAT WE DO, ALMOST ALL OF WHAT WE DO, BECAUSE WE HAVE TO TAKE CARE OF THE PATIENTS WHO ARE IN OUR BACKYARD. AND SO THE IDEA OF THE TRAINING COMPONENT, A SEPARATE REVIEW IS FINE BECAUSE IT GETS HARD FOR REVIEWERS TO WADE THROUGH 1800 PAGES OF APPLICATION BUT A FLAVOR OF THE UM1 AND THE GEOGRAPHIC REGION AND WHAT IS IMPORTANT TO THAT GEOGRAPHIC REGION NEEDS TO ALSO BE IN THE TRAINING AWARDS SO THAT THE REVIEWERS HAVE AN UNDERSTANDING OF THE FULL CTSA PROGRAM THAT ESSENTIALLY IS BEING REVIEWED EVEN THOUGH THEY ARE ONLY REVIEWING A SMALL PIECE. I THINK THAT THE NETWORK CAPACITY IS KIND OF GROWN AND EXPANDED, KIND OF WITHRIX AND TICKS AND TINS. NOW IT'S CD2H QUICKEN C3. HOW THE NETWORK CAPACITY GOES INTO THE BLUE ONE. SO NOW I HAVE GOTTEN THE COLOR-CODE UP HERE. I ALSO THINK THE GREEN IS GOING TO BE LOADED. SO I REALLY THINK THAT THE PAGE LIMITS, WE HAVE TO BE VERY CAUTIOUS OF BECAUSE THE REDUNDANCY IN THE APPLICATION COMES FROM ALL OF THE FACILITIES AND OTHER RESOURCES AND ALL THE THINGS THAT WE HAD TO ADD OVER AND OVER AGAIN TO REALLY GET A GOOD UNDERSTANDING OF A PROGRAM. WE NEED TO THINK ABOUT THAT BECAUSE IN THE CURRENT SCHEMA, A LOT OF THE CORES YOU SHOW AS ONE ARE REALLY TWO. THE BURDEN AND REGULATORY KNOWLEDGE. SO REALLY A LOT IS BEING PACKED IN THAT GREEN CLINICAL AND TRANSLATIONAL SCIENCE RESOURCES AND PILOTS. SO AT LEAST THINKING ABOUT SCALING THE PAGES TO REFLECT WHAT YOU'RE NOW FRONT LOADING INTO THESE DIFFERENT COMPONENTS I THINK WOULD BE VERY, VERY IMPORTANT. AND SO WITH THAT, I WILL YIELD THE FLOOR TO MY COLLEAGUES. >> OKAY. THANK YOU VERY MUCH. BECKY DO YOU WANT TO CHIME IN TOO AND THEN WE'LL GO TO PAULE? ARE YOU THERE? I THINK YOU'RE ON MUTE. >> I FORGOT TO UNMUTE. SORRY. SO MY COMMENTS REALLY ARE AROUND FOUR PRIMARY AREAS. SOME OVERLAP WAS WHAT WE JUST HEARD BUT I THINK MAYBE A LITTLE BIT DIFFERENT ANGLES. SO LET ME START WITH THE FIRST, WHICH IS IT I THINK THAT THE TRUE GENIUS IN THE INNOVATION OF THE CTSA PROGRAM OVER THE LAST 15 YEARS HAS BEEN THAT PROVISION OF THE NETWORK OF RESEARCH RESOURCES INCLUDING THAT INTEGRATION OF WORKFORCE DEVELOPMENT THAT IS CREATED THIS INTEGRATED ECOSYSTEM OF TRANSLATIONAL SCIENCE AT BOTH THE HUB AND CONSORTIUM LEVEL. BUT WHEN I LOOK AT WHAT IS BEING PROPOSED IN THE REORGANIZATION OF THE WAY THAT THE UM1, THE K, THE T, AND THE NEW CYSTS ARE, IT REMINDS ME OF A DECONSTRUCTED SALAD. ALL THE COMPONENTS ORDERS THERE BUT WHEN YOU SEPARATE THEM WE LOSE THE TRANSFORMATIVE CAPACITY AS A RECIPE, THAT KIND OF EXTRA STEP THAT HAPPENS THAT IS MORE THAN JUST ADDITIVE BUT MAN TIMES IS EXPONENTIAL. AND SO I THINK THAT ONE OF THE THINGS THAT NCATS NEEDS TO THINK STRONGLY ABOUT IS HOW DO WE RETAIN THAT SECRET SAUCE? HOW DO WE MAKE SOME OF THE PARTS GREATER SO THAT THAT WHOLE REALLY BECOMES THE TYPE OF THING THAT IS GOING TO MEET THE OVERARCHING GOALS. AND I THINK WITHIN THAT, AS I THINK ABOUT SEPARATING INTO MULTIPLE DIFFERENT BUDGETARY AREAS, AND I THINK BACK OVER THE PANDEMIC AND OTHER RESPONSES, I THINK IT POTENTIALLY LIMITS OR MAKES IT MUCH MORE DIFFICULT FOR ME TO THINK ABOUT AS A CTSAUPI, HOW WE DO THAT NIMBLENESS, HOW WE RESPOND QUICKLY AND HOW WE CAN REALIGN BUDGETS AND ACTIVITIES, SUPPORT, ALL THE COMPONENTS WAY THAT IS WE ARE SURE ARE SUCCESSFUL. SO THINKING ABOUT THAT AND THINKING ABOUT THOSE TYPES OF EVENTS. CERTAINLY WE HOPE WE DON'T HAVE ANOTHER PANDEMIC BECAUSE THERE WILL BE OTHER TYPES OF DISRUPTIONS THAT OCCUR BOTH ON A POSITIVE FASHION THAT WILL BE ADOPTED AS WELL AS THINGS THAT WE ARE GOING TO HAVE TO REALLY RESPOND TO AS CHALLENGES. AND WE NEED TO CREATE STRUCTURES AND ALLOW THAT FLEXIBILITY BOTH AT A HUB LEVEL AND A CONSORTIUM LEVEL IN ORDER FOR US TO BE SUCCESSFUL. AND SO, MAYBE AFTER I MAKE MY COMMENTS, I ASK FOR HOW YOU'RE THINKING ABOUT COMING UP WITH WAYS OF RETAINING THE BENEFIT RATHER THAN THAT SPLITTING AND SUBDIVIDING. I THINK THAT MY SECOND COMMENTS REALLY FOCUSED AROUND THE CRITICAL ROLE THAT THE CTSAs, AND I THINK A REALLY UNIQUE ROLE WHEN I THINK OF ALL THE WAY ACROSS ALL OF THE NIH AREAS I'M AWARE OF, IS OUR ROLE CATALYZING AND ENABLING SCIENCE BUT IT'S SCIENCE ACROSS AN ENTIRE TRANSLATIONAL SPECTRUM. AND I THINK THAT WE HAVE DONE A LOT OF APPROACHES THROUGH THE PILOT PROGRAMS AND OTHER INITIATIVES THAT HAVE REALLY WITHIN MOTIVATING USE CASES AND OTHERS HAVE DISCOVERED AND VALIDATED NEW METHODS AND APPROACHES AND TOOLS THAT ARE GENERALIZABLE AND CAN BE UTILIZED ACROSS THINGS. BUT IF I UNDERSTAND THE LAST PART, THIS NEW COMPONENT OF THE UM1 THAT IS BEING PROPOSED AND THIS CONCEPT PROPOSAL, I THINK THAT WE HAVE TAKE KNOW WHAT HAS BEEN THIS INCREDIBLY ROBUST SYSTEM -- WE HAVE TAKEN WHAT HAS -- SUPPORTING LITERALLY HUNDREDS OF PROJECTS ACROSS THE CTSA CONSORTIUM, IF NOT THOUSANDS, THAT HAVE DONE THIS AND WE ARE GOING TO DISTILL THIS INTO A LOT OF RESOURCES GOING TOWARDS A SINGLE PROJECT AND I'M NOT SURE AGAIN THAT THE VALUE, THAT THE BENEFIT OF THIS INVESTMENT IN A SENGEL PROJECT RATHER THAN REALLY MAYBE BETTER DEFINING OR THINKING ABOUT HOW DO WE USE A PILOT PROJECT IN OTHER INNOVATIONS WITHIN A CTSA HUB, AS WELL AS A CONSORTIUM, HOW COULD WE MAY BE REACH THOSE SAME TYPES OF GOALS? AND I GUESS I WOULD ASK YOU WITHIN THOSE SINGLE PROJECTS, HOW WOULD YOU MEASURE SUCCESS? AND SUCCESS AS TO HOW THAT IS GOING TO REALLY BENEFIT TRANSLATIONAL SCIENCE AND THE CONSORTIUM AS A WHOLE? AND THEN I THINK MY THIRD AREA STAFF AT LEAST HIGHLIGHTING SOME THINGS TO THINK ABOUT, IS THAT WE REALLY THOUGHT ABOUT TRANSFORMING AND ENHANCING THE QUALITY OF INNOVATION, EFFICIENCY AND EFFECTIVENESS BUT IT'S ACROSS THE ENTIRE TRANSLATIONAL SPECTRUM. AND KIND OF THE DESCRIPTION THAT DR. CRIMINALLA AND DR. ROSE MAN GAVE TODAY, THIS IS MUCH MORE TIGHTLY FOCUSED WITHIN HUMAN SUBJECTS RESEARCH. SO ALTHOUGH THAT IS A CRITICALLY IMPORTANT COMPONENT, CERTAINLY THAT AREA OF HOW DO YOU EFFECTIVELY BRING THAT SCIENCE INTO THOSE FIRST IN MAN STUDIES IN ORDER TO BRING NEW THERAPEUTICS AND DIAGNOSTICS AND PREVENTIVE STRATEGIES, OR HOW DO YOU TAKE QUESTIONS THAT ARISE IN THE FIELD, FOR EXAMPLE WHEN WE FIRST SAW THE COVID-19 CASES. HOW DO YOU BRING THAT BACK TOWARDS THE BENCH AND THEN BRING IT BACK INTO THERAPEUTIC TARGETS AND OTHER APPROACHES? AND I THINK THAT IF WE LIMIT THE PARTNERSHIPS TO PRIMARILY THOSE THAT HAVE CLINICAL RESEARCH CAPACITIES AND ARE MORE BROADLY CONSIDERING HOW DO WE SUPPORT THAT FULL TRANSLATIONAL SPECTRUM ALL THE WAY TO DISSEMINATION AND IMPLEMENTATION SCIENCE THAT AGAIN WE LOSE SOME OF THE UNIQUENESS OF THE CTSA PROGRAM AND THE CONSORTIUM TO REALLY ACCELERATE THAT TRANSLATION, WHICH COMES MY LAST ONE. I HEARD REALLY SILENCE AROUND THAT AREA OF INNOVATION, COMMERCIALIZATION, ENTREPRENEURSHIP, AS ANOTHER PATHWAY TOWARDS TRANSLATION. AND REALLY I WANTED TO ASK, IS THAT IMPORTANT PART OF THE CTSA INITIATIVE? SO THESE ARE REALLY THE FOUR AREAS THAT I THINK THAT KIND OF FURTHER CLARIFICATION THINKING ABOUT HOW TO MEASURE THE IMPACT OF THESE CHANGES TO REALLY SEE THAT A CHANGE IN THIS CONCEPT PROPOSAL AND A CHANGE IN THE CTSA PROGRAM IS GOING TO MAKE THE DESIRED GOALS TO GET MORE DRUGS TO MORE PEOPLE AT THE APPROPRIATE TIME. >> THANK YOU, BECKY. THAT WAS PACKED AS WELL. I WANT TO ASK MIKE AND ERICA AND PAULE, HOW WOULD YOU LIKE TO PROCEED NEXT? WOULD YOU LIKE TO RESPOND TO ANY POPES THAT PAULA OR BECKY HAVE MADE OR SHOULD WE ASK FUEL MAKE HIS DISCUSSION POINTS? >> I WOULD LET PAULE GO FIRST. >> OKAY. PAULE? >> I'LL KEEP IT SHORT. SO FIRST I AGREE WITH BECKY'S COMMENTS ABOUT THE DANGER OF A SINGLE PROJECT FOCUS. I ARTICULATED SOME OF THOSE IN CHAT SO I WON'T REPEAT. REFLECTING ON IT, WE HAVE SEEN A LOT MORE INNOVATION OUT OF LOTS OF SMALL PILOTS THAN WE HAVE OUT OF BIG HUGE PROJECTS. SO ECHO THAT. I AM NERVOUS ABOUT WHAT SEEMS TO BE A DEEMPHASIS ON NETWORK CAPACITY. I KNOW THE COLLABORATIVE GRANTS SHOULD TAKE CARE OF SOME OF THAT BUT I THINK THERE IS POWER IN NETWORK CAPACITY WHERE ALL 60CTSA HUBS ARE COMBINED SO JUST BEING CAREFUL THERE. MIKE, YOUR COMMENT ABOUT THE OLD SECTIONS BEING COOKIE CUTTERS. I SMILED ON THAT ONE BECAUSE I THINK YOU'RE RIGHT AND I HAVE -- ANY NOBODY OF TIMES THOUGHT INTO A SECONDS WAS QUITE LIMITING BECAUSE WE ONLY HAD SO MANY PAGES AND WE NEEDED TO COVER A LOT OF THE STUFF THAT -- A LOT OF THE COOKIE CUTTER STUFF. BUT I ALSO WANT TO POINT OUT THAT THOSE COOKIE CUTTERS HAVE SERVED A GOOD PURPOSE. ABOUT TWO YEARS AGO, I WAS LOOKING AT THE RFA AND STARTED GOING BACK AND LOOKING AT OLD RFAs AND COMPARING AND I REALIZED THAT AT LEAST FOR THE INFORMATICS COMMUNITY, THE RFA HAD BEEN A HUGE DRIVER FOR BASICALLY CREATING MATURITY MODELS AT OUR INSTITUTIONS. SO I WOULDN'T DISCOUNT THE VALUE OF THAT. I DID PUT SOME OTHER COMMENTS ABOUT CONCERNS ABOUT REDUCING THE SECTIONS IN THE CHAT AS WELL BUT DEFINITELY AGREE WITH REDUCING THE REDUNDANCY. AND THEN FINALLY, I AGREE WITH OTHERS. I THINK SEVERAL ECHOED THE SAME COMMENT AROUND THE VALUING OR EVALUATING THE VALUE OF PARTNERS JUST ON THE NIH CLINICAL RESEARCH BUDGET. I THINK IT IS LIMITING. I THINK WE ARE GOING TO LOSE RICHNESS OF THE COLLABORATIONS. THAT IS GOING TO BE AN OUTREACH. THE COMMUNITY ENGAGEMENT, BEING ABLE TO CONNECT WITH RURAL PARTNERS AND UNDERSERVED. SO I THINK WE NEED TO BE CAREFUL ON THAT ONE. I'M DONE, JONI. >> OKAY. THANK YOU, PAULE. SO THIS IS THE END OF THE DISCUSSANTS. I'D LIKE TO ALLOW MIKE AND ERICA TO RESPOND TO MANY OF THE QUESTIONS THAT THEY CAN ADDRESS NOW TO THOSE POINTS AND THEN WE WILL OPEN IT UP AND I HAVE A LIST OF PEOPLE AND THEIR NAMES WHO WERE FIRST IN LINE AND WE'LL GET TO YOU IN JUST A SECOND AFTER MIKE AND ERICA HAD A CHANCE TO RESPOND. SO MIKE, OVER TO YOU. >> THANK YOU. LET ME JUST ADDRESS THE CLINICAL EMPHASIS BECAUSE I THINK THIS HAS BEEN QUITE CONFUSING TO A LOT OF PEOPLE IT'S NOT A DESIRE TO SAY DON'T HAVE ANYTHING TO DO WITH PEOPLE WHO DON'T DO CLINICAL WORK. IT'S THAT RIGHT NOW THE WAY THE CALCULATION IS, IF I SAY YOU'RE A PARTNER, I GET TO INCLUDE ALL OF YOU AND PEOPLE -- THERE IS THE ABILITY TO, FOR LACK OF A BETTER TERM, GAIN THE SYSTEM TO INCREASE THE AWARD. NOW THAT'S UNDER THE 2.5% TIE. WHAT WILL HAPPEN UNDER THE SYSTEM WE ARE PROPOSING IS THERE WON'T BE ANY ADVANTAGE TO BRINGING IN SOMEBODY WITH A LARGE NIH FUNDING. IT'S NOT GOING TO HELP YOU ANYMORE IN THAT REGARD T DOESN'T MEAN YOU CAN'T COLLABORATE WITH THOSE PEOPLE AND WE CERTAINLY DON'T WANT TO ELIMINATE THAT. BUT BEING A PARTNER MEANS MONEY IS FLOWING IN CERTAIN DIRECTIONS AND THE INCENTIVE HAS BEEN TO JUST FIND PARTNERS WITH A LOT OF NIH FUNDING BECAUSE THAT BRINGS IN MORE MONEY OVERALL. WE HAVE LOOKED AT MODELING IN TERMS OF, LET'S SAY, THE -- MANY OF THESE HBCUs AND UNDER REPRESENTED MINORITY INSTITUTIONS AND IN FACT, THEIR BREAKDOWN WITH REGARD TO CLINICAL FUNDING VERSUS TOTAL NIH FUNDING IS NOT SUBSTANTIALLY DIFFERENT FROM THE REST OF NIH. AND SINCE THIS IS NOT NOW THE TOTAL NOT NOW GOING TO CONTRIBUTE WHAT YOU'RE GOING TO GET, IN TERMS OF A TIE PORTION TO PUT YOU INTO A CATEGORY, THE MODELING WE DONE WITH THIS IS THAT THERE REALLY IS VERY LITTLE CHANGE. THE FUNDING LEVELS OF INDIVIDUAL HUBS WILL RECEIVE IS GOING TO BE PLUS OR MINUS 5% OF WHAT YOU'RE SEEING RIGHT NOW. SO WE DON'T ANTICIPATE ANY SIGNIFICANT CHANGES FOR THE VAST MAJORITY OF CTSAs AND AGAIN, IT IS NOT DISCOURAGING PEOPLE FROM COLLABORATING WITH ANY INSTITUTION THAT DON'T HAVE A LOT OF CLINICAL RESEARCH. AUTO JUST THAT IT WON'T CONTRIBUTE TO PUTTING YOU INTO A PARTICULAR CATEGORY BUT WE DON'T SEE MUCH CHANGE IN TERMS OF THE CURRENT STRUCTURE OF THE WAY THE CTSAs ARE PARTNERING AND COLLABORATING. I HOPE THAT HELPS. >> THANK YOU, MIKE. AND ANDREW HAS BEEN WANTING TO CHIME IN ON THIS AS WELL. ON THIS PARTICULAR TOPIC. SO ANDREW, I WANT TO GIVE YOU A CHANCE TO DO THAT BECAUSE YOU HAVE MADE A COUPLE OF COMMENT RESPECTIVE OF THIS PARTICULAR QUESTION. >> I WAS HOPING THAT WE COULD ACTUALLY TURN THE SLIDE DECK TO THE SPECIFIC PAGE THAT HAS THE CURRENT AND PROPOSED FOA LANGUAGE SO WE CAN KNOW WHAT WE ARE TALKING ABOUT. AND CAN I MAKE A REQUEST IN THE FUTURE WE GET COPIES OF THE SLIDES IN ADVANCE BECAUSE I SPENT A BIT OF TIME PREPARING FOR THESE MEETINGS SO I LIKE TO HAVE THE MATERIALS IN ADVANCE TO GO OVER THEM. I GUESS FIRST OF ALL, I WANT TO SAY THE CTSA PROGRAM IS ONE OF THE CROWN JEWELS OF NCATS. IT IS NOT JUST A NATIONAL RESOURCE IT'S A NATIONAL TREASURE. WE TALK ABOUT THE VALUE. AS A FINANCIAL ECONOMIST I'M FOCUSING ON THE FUNDING AND THE LANDSCAPE OF THE PROCESS BY TAKING IDEAS FROM THE LABORATORY INTO THE CLINIC. THIS IS EXACTLY FOCUSED AND DEALING WITH THE VALLEY OF DEATH. WITHOUT CTSA, THE VALLEY OF DEATH WOULD BE A LOT WORSE. AND SO I ACTUALLY THINK THAT WE SHOULD DO ALL OF US, DO WHATEVER WE CAN TO INCREASE THE TOTAL AMOUNT OF FUNDING FOR CTSA AND LET 1000 FLOWERS BLOOM IT'S JUST AN INCREDIBLE RESOURCE IN ALL SORTS OF WAYS, AND PARTICULARLY OVER THE LAST 12 MONTHS, I HAVE SEEN WHAT HAS BEEN GOING ON WITH A VARIETY OF CTSAs WITH RESPECT TO COVID. AND THANK GOD FOR WHAT HAS BEEN HAPPENING AT UNIVERSITIES AND RESEARCH LABS AROUND THE COUNTRY. SO THAT IS THE FIRST THING I WANT TO MENTION. BUT WITH REGARD TO THE SLIDE, CAN WE GO BACK TO THAT? FOR SOME REASON WE WERE ON THAT SLIDE AND NOW -- >> RIGHT THERE. HOLD. THE PROPOSED LANGUAGE HAS THIS ONE LITTLE CHANGE THAT IS NOT INNOCUOUS. IT SAYS THE ROLLING AVERAGE OF PREVIOUS 5-YEAR NIH CLINICAL RESEARCH. AND THAT WORD, CLINICAL, BASICALLY DISCOURAGES PARTNERSHIPS WITH UNIVERSITIES LIKE MIT, CALL TECH, CARNEGIE MELLON, WHERE THERE IS NOT A LOT OF CLINICAL ACTIVITY GOING ON BUT WHERE THERE IS A LOT OF SCIENCE GOING ON THAT WORKS WELL WITH OTHER CLINICAL PARTNERS. FOR EXAMPLE, THE MIT TUFTS PARTNERSHIP HAS BEEN INCREDIBLY PRODUCTIVE BUT I ALSO KNOW THAT AT CALL TECH, THEY ARE STARTING TO DO MORE WITH THE CITY OF HOPE. AND THIS ONE SMALL CHANGE IS GOING TO HAVE A BIG IMPACT ON THEM. IT MAY NOT HAVE A BIG IMPACT IN THE GRAND SCHEME OF THINGS BUT IT HAS A HUGE IMPACT IN TERMS OF THE KIND OF RESEARCH THAT IS BEING DONE AT NON-CLINICAL RESEARCH UNIVERSITIES. AND IT SEEMS TO ME THAT ONE OF THE POINTS OF NCATS IS TO CREATE THOSE KINDS OF INTERDISCIPLINARY CONNECTIONS BETWEEN ENGINEERING, DATA SCIENCE, BETWEEN MECHANICAL ENGINEERING AND MIT PLAYED A BIG ROLE IN PROVIDING PPE TO THE STATE OF MASSACHUSETTS. I WOULD SUGGEST JUST SIMPLY DELETING THE WORD, CLINICAL FROM NIH CLINICAL RESEARCH FUNDING IN A PROPOSED LANGUAGE AND KEEPING IT THE WAY IT WAS AND ALLOWING COLLABORATIONS TO SEE. >> SO YOU'RE SAYING CALL TECH AND -- AND FULL DISCLOSURE, I'M A GRADUATE OF CALL TECH. SO I WAS THERE. CALL TECH AND MIT WOULD HAVE NO INTEREST IN ENGAGING WITH THE ACADEMIC COMMUNITY UNLESS THEY ACTUALLY RECEIVED SPECIFIC FUNDING FROM THE ACADEMIC COMMUNITY? >> NOT AT ALL. I THINK THAT THEY WOULD HAVE AN INTEREST IN ENGAGING BUT THE CLINICAL CENTERS HAVE A DISINCENTIVE TO PARTNER WITH THEM. >> NO, NO. BUT THERE IS NO DISINCENTIVE. THEY ARE NOT BEING HURT BY THIS BECAUSE ROOTS NOT PRECLUDING THEM FROM GOING OUT AND THEY NEED TO HAVE CLINICAL PARTNERS. AND SO WHAT WE HAVE SEEN IS THAT IF WE DO THE MODELING, INSTITUTIONS THAT ARE EVEN LARGELY PARTNERED WITH A LOT OF UNDER REPRESENTED MINORITIES, THEY ACTUALLY COME OUT BETTER UNDER THIS PARADOX. MOST PEOPLE DON'T CHANGE AT ALL. IT REALLY DOESN'T INFLUENCE THE VAST MAJORITY OF PEOPLE, THERE IS ABSOLUTELY NO DIFFERENCE. >> THAT'S NOT WHAT I HEARD FROM THESE UNIVERSITIES AND THE REASON WE GOT THIS LETTER WAS BECAUSE THEY ARE CONCERNED ABOUT THIS ONE PARTICULAR ISSUE AMONG LITTLER. >> THAT'S BECAUSE I THINK BECAUSE THEY ARE THINKING IN TERMS OF THE 2.5% TIE, WHICH IS WHAT IS THE PARADIGM THAT IS GOING ON FOR 50 YEARS AND THAT IS BEING CHANGED. SO BY PUTTING YOU INTO A CATEGORY, IT'S NOT HELPING OR HURTING ANYMORE, IT'S JUST DEFINING -- >> AND SORRY. I THINK YOU CUT OFF THERE JUST FOR A MINUTE. I THINK THE OTHER THING IS WHAT ANDREW IS TALKING ABOUT IS THINKING ABOUT JUST TAKING A LOOK AT THAT LANGUAGE AND CONSIDERING HOW TO BEST REFLECT THAT BETTER IN WHAT YOU'RE SAYING. I THINK THAT'S THE MAIN POINT HERE. I THINK THAT IS SOMETHING THAT WE CAN CERTAINLY DO. SO I'D LIKE TO -- WE REALLY NEED TO GO AHEAD AND MOVE FORWARD TO THESE NEXT COMMENTS FROM OTHER INDIVIDUALS HERE. GEORGE HAD TO SIGN OFF AND HE LET ME KNOW THAT HE WAS SIGNING OFF. SO ALTHOUGH HE WAS FIRST, I'M GOING TO MOVE ON TO GO TO PAULE. YOU HAD SOME COMMENTS IN THERE BUT SINCE YOU WERE A DISCUSSANT, I THINK YOU RELAYED THOSE. I WANTED TO MAKE SURE WE CAPTURED YOUR COMMENTS FROM THE DISCUSSANT SECTION? >> I HAD SOME COMMENTS IN THERE THAT PROBABLY STAND ALONE. SO HAPPY FOR THOSE TO JUST BE COLLECTED AND USED DOWNSTREAM. >> OKAY. GREAT. THANK YOU. THEN WE WILL GO TO MARSHAL FIRST AND THENERAGEESH WAS NEXT. SO MARSHAL PLEASE GO AHEAD. >> THIS WILL GIVE YOU YOUR CHANCE TO KICK ME OFF COUNCIL IF YOU WANT TO. I GO ALL THE WAY BACK TO THE GCRC DAYS OF YORE AND THEN GREW UP THERETO THE CTSA PROGRAMS AND EVERY ELSE. SO MANY YEARS OF WATCHING WHAT IS HAPPENING. WHAT I HAVE SEEN IS THE AMOUNT OF FUNDING COMING TO AN INSTITUTION, WHILE IMPORTANT FOR THE CTSA IS NOT THE PRIMARY DRIVER OF THE APPLICATION. IT'S THE NETWORKING AND THE PRESTIGE THAT COMES WITH BEING ABLE TO SAY YOU ARE A CTSA, NCATS INSTITUTION. SO I ALMOST VIEW THE PURPOSE OF THE CTSA PROGRAM -- SORRY, THE CTSA PROGRAM MORE AS A ESSENTIAL ENGINEERING TOOL TO PROMOTE COLLABORATION, TO PROMOTE NETWORKING, TO PROMOTE STANDARDS OF WHAT PEOPLE ARE DOING THERE THAN ALMOST ANYTHING ELSE. I'M A LITTLE WORRIED THAT SHIFTING THE FOCUS AROUND PRIMARY -- SINGLE PROJECT, THINGS LIKE THAT, IS GOING TO I THINK SHIFT THE PARADIGM THERE A LITTLE BIT. AND LIKE I SAID, I COME FROM A DAY AND AGE WHEN IT WAS PRIMARILY AROUND PROVIDING INFRASTRUCTURE AT THE INSTITUTIONS FOR WHATEVER RESEARCH THEY WERE DOING THERE AND THEN IT BECAME MORE OF AROUND PILOTS AND NETWORK PROJECTS, THINGS LIKE THAT. SO I THINK THAT'S JUST SOMETHING WE WANT TO MAKE SURE WE DON'T LOSE THROUGH THIS PROCESS. BECAUSE LIKE I SAID, I TUBING A LOT OF DIFFERENT GROUPS THAT ALL WANT TO GET CTSA GRANTS AND THE THEY REALLY PROBABLY LOSE MONEY ON THEM. I WOULD BE CURIOUS TO SEE IF ANYONE ELSE WHO HAS GOT ONE OF THEIRS IF IT'S A HUGE FINANCIAL BOONE YOUR INSTITUTION WHEN YOU DIVIDE IT ACROSS 60 -- EVEN THOUGH IT'S A HUGE SINGLE POT, THE PIE HAS BEEN SLICED INTO A LOT OF SMALLER SLICES. >> IF I SHALL JUST COMMENT ON THE SINGLE PROJECT. A LOT OF PEOPLE BROUGHT THIS UP AND IT'S PROBABLY ONE OF THESE THINGS WHERE THE SPECIFIC LANGUAGE IN THE FOA, WHICH WE'RE NOT HERE TO REALLY DISCUSS IN DETAIL, WOULD PROBABLY BE HELPFUL. THE IMPETUS AROUND RESEARCH PROJECT IS REALLY TO TRY TO HAVE THE HUBS IDENTIFY WHAT THEY RECALLED AS SIGNIFICANT OR PROBLEMATIC TRANSLATIONAL SCIENCE BOTTLENECK. AN ISSUE AND THEN BUT IDENTIFY A VERY APPROPRIATE USE CASE THAT IS TIED TO THEIR PARTICULAR AREA OF EXPERTISE OR SPECIALTY OR CAPABILITIES WITHIN THAT INSTITUTION. AND REALLY APPROACH THAT, NOT JUST AS A PROJECT IN AND OF ITSELF, BUT AS DEMONSTRATION OF A USE CASE THAT CAN REALLY HAVE MUCH MORE BROAD APPLICABILITY TO TRANSLATIONAL SCIENCE IN GENERAL. AND THAT'S THE INTENTION AROUND THE QUOTE RESEARCH PROJECT. >> IF I COULD MAKE ONE LAST COMMENT ON THAT. >> SURE. >> WE HAD THAT SAME THING IN THE RARE DISEASE CLINICAL RESEARCH NETWORK WHERE THE DIFFERENT CENTERS HAD A PRIMARY PROJECT OR TWO PRIMARY PROJECTS. WHAT I FOUND AND WE WERE ONE OF THE FIRST CENTERS BACK WITH CHILDRENS AND EVERYBODY IN 2004. AND WHAT I FOUND IS THAT IT DISTRACTED FROM THE GOAL AND PURPOSE AND THE COLLABORATION, BECAUSE TYPICALLY ONE CENTER OR ONE OF THE PARTNERS IS GOING TO BE THE ONE THAT IS GOING TO EXECUTE THAT PRIMARY PROJECT AND THAT ACTUALLY PULLED RESOURCES AROUND FROM WHAT YOU WERE DOING AROUND NETWORK AND SUPPORTING MORE COLLABORATIVE RESEARCH. AND THAT'S AN OBSERVATION I'D MAKE. >> WE WANT TO AVOID THAT UNINTENDED CONSEQUENCE. >> THEY THINK IS SOMETHING THAT CAN BE ADDRESSED FOR SURE GOING FORWARD. [ MULTIPLE SPEAKERS ] >> I'LL JUST ADD ONE COMMENT ABOUT THE RESEARCH PROJECT. THIS IS REALLY SOMETHING THAT WE HEARD FROM THE RFI THAT THE HUBS REALLY DIDN'T HAVE SUFFICIENT FUNDS TO BUILD OUT CERTAIN RESEARCH AREAS WITHIN THE HUB ACTIVITIES AND SO ALONG THE RESEARCH PROJECT THE FUNDING WILL BE FLEXIBLE AS WELL. SO WE HEAR YOUR CONCERN ABOUT THIS IS ANOTHER ADDED ACTIVITY BUT WE ARE THINKING ABOUT THE FLEXIBILITY AND THE NEED AND WHAT STAKEHOLDERS HAD REQUESTED WITH THIS PARTICULAR OFFERING. >> AND ERICA WHAT I WOULD SAY IS YOU'RE VERY WELL RESOURCED CENTERS, THIS IS REALLY A NONISSUE FOR THEM. BUT THOSE CENTERS THAT YOU'RE TRYING TO JUMPSTART AND BRING UP TO A HIGHER LEVEL OF RESEARCH COLLABORATION, I THINK DIVERSION TOWARDS A SPECIFIC PROJECT IS PROBABLY GOING TO BLUNT SOME OF THAT EFFECT. I'LL STOP NOW. >> THANK YOU, MARSHAL. >> THANK YOU. >> WE CAN DEFINITELY NOTE THAT. ERAGE YOU'RE NEXT. >> RAJ. >> IF YOU DECIDE TO NOT GIVE UP MARSHAL I'LL GIVE YOU A CHANCE TO PICK ON SOMEBODY ELSE. I'M FLIPPING BACK AND THINKING ABOUT THE CTSAs ARE SUCH A LARGE ASPECT OF THE ENTIRE BUDGET AND I GUESS IT FEELS LIKE A FORGONE CONCLUSION BECAUSE IT'S A LINE ITEM IN THE BUDGET AND YOU HAVE TO DO IT AND SO ON AND SO FORTH. BUT I DON'T KNOW WHERE THE CHANCES FOR US TO STEP BACK AND THINK ABOUT OTHER CREATIVE WAYS TO THINK ABOUT USING THIS FUNDING ALLOTMENT IN THE CONTEXT OF THE GOALS OF NCATS. SO I GUESS I'M JUST NOT BINDING TO THE PREMISE. MAYBE I'M DISAGREEING WITH ANDREW DIRECTLY HERE THAT THE CTSAs ARE THE WAY TO ESSENTIALLY FILL THE VALLEY OF DEATH GAP HERE. ALTHOUGH I WILL MAKE ONE SIDE REMARK ABOUT THE THOUSAND FLOWER BLOOM. I DON'T KNOW IF ANYBODY EVERY RESEARCH INTO THE PROVIDENCE OF THAT QUOTE. TO ALLOW DISSONANCE TO COME OUT TO BLOW THEIR HEADS OFF. SO KEEP THAT IN MIND. SO I WOULD JUST LIKE TO HEAR EITHER FROM YOU JOHNNY OR FROM MIKE. I'M NOT TRYING TO KILL THE CTSA OR SAY DO ANYTHING LIKE THIS. I WAS INVOLVED IN THE EARLY DAYS FROM EVALUATING THE GCRC CONCEPT TO THE CTSAs TO ALL OF THIS AND THE QUESTION WHERE IS THE FLEXIBILITY? TO BEEN WHAT TO DO WITH IT? >> I THINK ONE OF THE DRIVING ISSUES IS THAT WHAT WE HAVE BEEN TRYING TO ADDRESS IS TO PROVIDE THE HUB WITH MORE FLEXIBILITY. AS MORE AND MORE THINGS HAVE BEEN ADDED OVER THE YEARS, YOU GO BACK 15 YEARS, INFORMATICS WAS QUITE IN AN IN FEN TILE STAGE RELATIVELY SPEAKING. A LOT OF THE ACTIVITIES THAT CTSAs HAVE BEEN DOING HAVE GOTTEN MORE AND MORE PROMINENCE OVER TIME. AND AT SOME POINT, WE JUST CAN'T ADD MORE ELEMENTS OF WHAT THEY NEED TO DO. WE WANT TO GIVE THEM THE FLEXIBILITY. IT DOESN'T MEAN WE ARE TRYING -- WE DON'T WANT TO NECESSARILY TAKE ANYTHING AWAY BUT WE KNOW THAT UNFORTUNATELY, UNLESS FUNDS ARE SUBSTANTIALLY INCREASED, THE HUBS WILL HAVE TO MAKE CHOICES IN TERMS OF WHAT THEY WANT TO FOCUS AND WE WANT TO GIVE THEM THE ABILITY TO FOCUS ON THOSE ELEMENTS THAT THEY REGARD AS -- WHERE THEY CAN BE MOST IMPACTFUL BECAUSE OF WHAT THEY HAVE LOCALLY IN TERMS OF EXPERTISE, PATIENT POPULATIONS, WHAT THEY WANT TO MAKE THEIR FOCUS. AND SO WE TRIED TO BE AS -- TRIEDED TO PROVIDE A MECHANISM WHERE THEY HAVE MORE FLEXIBILITY IN TERMS OF ALLOCATING THEIR FUNDS WITHIN THE CTSA TO REALLY FOCUS AND EMPHASIZE ON THE ELEMENTS THEY FEEL WHERE THEY CAN BE MOST IMPACTFUL. LET 1000 FLOWERS BLOOM. AND ADDRESSING THE VALLEY OF DEATH, THE CTSAs ARE THERE BUT WE CAN'T BE THE ONLY PLAYER. WE ARE NOT THE ONLY PLAYER. AT LEAST AT THIS POINT IN TIME. SO RATHER THAN TRYING TO BE OVERLY PRESCRIPTIVE IN HOW WE APPROACH THE CTSAs, IN ESSENCE, I'M LETTING 60 HUBS BLOOM TO REALLY TELL ME WHAT THEY WANT TO FOCUS ON. THE RESEARCH PROJECT, ONE OF THE THINGS WE HOPE TO LEARN FROM THAT IS WHAT DOES THE COMMUNITY REALLY WANT TO DO AND WHERE DO THEY THINK THEY REALLY SHOULD BE PUTTING THEIR RESOURCES TOWARDS RATHER THAN LETTING PEER REVIEW TELL US WHICH SHOULD BE DONE IN THIS WAY? WE THINK IT WILL BE PART OF THE PEER REVIEW PROCESS BUT NOT THE ENTIRE -- IT WON'T BE THE ONLY THING THAT GETS PEER-REVIEWED IN TERMS OF APPLICATION. IT GIVES THE POTENTIAL TO REALLY IDENTIFY CONCEPTS AND IDEAS AND INNOVATIVE APPROACHES THAT MAYBE CAN'T NECESSARILY SURVIVE ON THEIR OWN INDEPENDENTLY BUT THE HUB CAN REALLY NURTURE IT ALONG. WILL IT ALL BE SUCCESSFUL? I DOUBT IT. AND THAT'S THE NATURE OF THE SCIENCE. >> OKAY. THANK YOU. WE ARE GOING TO MOVE ON TO MATTHIAS AND GENERAL. WE ARE PUSHING THE TIME LIMITS HERE. SO PLEASE BE SUCCINCT AND THEN WE'LL MOVE TO GEORGE FOR HIS FINAL COMMENTS FOR THIS SESSION. >> SUMMERY [ INAUDIBLE ] SHOWN HOW CTSAs CAN COME TOGETHER TO BUILD A NATIONAL RESPONSE. IT NEEDS TO BE RETAINED AND IF YOU HAVE 60 INDIVIDUALIZED -- ONE OF VERY FEW MECHANISMS WE HAVE -- STRONGLY ENCOURAGE TO LOOK AT POSITIVE LESSONS LEARNED ON COVID RESPONSE -- >> THANK YOU. AND I THINK WE MIGHT EVEN ADDRESS THAT STILL MOVING FORWARD IN THESE OTHER CONCEPT CLEARANCES THAT WE STILL NEED TO GO THROUGH. SO MAYBE WE COULD ADDRESS THAT TOO. AND THEN WE -- [ MULTIPLE SPEAKERS ] >> LET ME ADD. THE HUB PROGRAM IS NOT THE ONLY COMPONENT OF THE CTSA THAT REALLY ADDRESSES SOME OF THOSE THINGS. N3Z A GOOD EXAMPLE OF CD2H AND MOVING FORWARD IN THE CONSORTIUM-WIDE RESOURCE CENTERS, THERE IS ALWAYS GOING TO BE CERTAIN ELEMENTS AND CERTAIN TOPICS THAT ARE BETTER HANDLED AT A CONSORTIUM LEVEL THAN AN INDIVIDUAL HUB. AND SO, WE AREN'T TALKING ABOUT ANY OF THOSE EXTRA HUB ACTIVITIES TODAY. >> THANK YOU. AND GEORGE. YOU'RE BACK ON. >> I'M BACK ON. I'LL BE BRIEF SO YOU'RE GOING TO TAKE RAJ OFF AND MARSHAL OFF AND YOU'RE NOT GOING TO LET ME ON. >> YOU LOOK LIKE YOU'RE IN A HELICOPTER. >> FLYMAKER ON THE WAY TO AN AIRPORT. MY COMMENT IS THAT ALLOWING 60 FLOWERS TO BLOOM AND ESSENTIALLY BEING A FINANCING MECHANISM FOR DISPARATE HUBS IS GOING AGAINST THE GRAIN HERE WHERE WE BRAG ABOUT WHAT WE DID WITH COVID WHICH WAS NOT JUST LETTING 1000 FLOWERS BLOOM BUT WHETHER IT WAS GREATER CONCENTRATION ON A PROBLEM AND HOW TO TRANSFORM EXISTING SYSTEMS TO BEND TO SOLVE THE PROBLEM. THE THRUST IS LET US GET MASSIVE TRANSFORMATIONAL, A LARGE TRANSFORMATIONAL VEHICLE TO DECIDE WHAT MAJOR PROBLEMS NEED TO BE SOLVED AND THEN SOLVE THEM WITH NEW CAPABILITIES. I THOUGHT THAT THE ROOTS OF NCATS AND THE ROOTS OF CTSA WAS BASICALLY TO INCREASE THE PERFORMANCE OF THE CLINICAL TRIAL SYSTEM ACROSS ALL THERAPEUTIC AREAS. BUT THERE IS NO PERFORMANCE-BASED MECHANISM HERE TO REWARD THOSE WHO ARE CONTRIBUTING TO THAT PARTICULAR OUTPUT SO THEN THE FACT YOU'RE MEASURING CAPACITY AND THEIR DESIRES BUT NOT ACTUALLY SAYING, OUR GOAL AS A NATION IS TO EXPEDITE THERAPEUTIC DEVELOPMENT AND THEN DELIVER THEM TO THE PATIENTS THAT ARE APPROPRIATE FOR THOSE THERAPEUTIC OUTPUTS. SO WE ARE NOT MEASURING AGAINST THAT. SO IT DOESN'T SEEM TO BE ACCOMPLISHED IN A NATIONAL PURPOSE. IT DOESN'T SEEM TO BE CREATING A TRANSFORMATIONAL PURPOSE. IT SEEMS TO BE A FINANCING MECHANISM FOR 60 DIFFERENT IDEAS. AND THAT DOESN'T STRIKE ME AS THE CORE OF WHAT WE WERE THINKING WE WERE DOING WITH NCATS. BUT I AM THE LEAST CAPABLE OF ANSWERING THAT QUESTION SINCE ADVISORY COUNCIL. BUT IT JUST DOESN'T STRIKE ME AS FROM A BUSINESS PERSPECTIVE WHAT WE OUGHT TO BE DOING WITH THE CTSA PROGRAM. THE END. >> THANK YOU, GEORGE. APPRECIATE THOSE COMMENTS. WITH, THAT I THINK WE NEED MOVE ON TO THE NEXT PROPOSAL. ANNA, JUST A TIME CHECK FROM YOU. DO WE NEED TO TAKE A BREAK? CAN WE GO AHEAD AND MOVE FORWARD IN THE INTEREST OF TIME? IF YOU NEED TO TAKE A BREAK, YOU CAN STEP AWAY. >> LET'S MOVE FORWARD AND WE CAN TAKE A BREAK AFTER THIS ONE IF WE MUST BUT WE ARE CRUNCHED ON TIME. SO LET'S KEEP GOING. >> OKAY. GREAT. SO I'M ERICA ROSEMONT, NOT PABLO. HE IS AT THE HOSPITAL RIGHT NOW. SO I'M GOING TO BE PRESENTING FOR HIM THE SPECIALIZED INNOVATION PROGRAM CONCEPT. NEXT SLIDE, PLEASE. I MENTIONED EARLIER THE CONCEPT I'M ABOUT TO PRESENT IS PART OF THE INTEGRATED SUITE OF LIMITED COMPETITION INITIATIVES TO ADDRESS THE CTSA PROGRAM, EVOLUTION AND FEEDBACK. RECEIVED FROM THE COMMUNITY THROUGH THE RFI PROCESS LISTED HERE. THE CONCEPT IS AIMED AT PROVIDING SUPPORT TO SPECIALIZED INNOVATION PROGRAMS THROUGH AN RC2 FUNDING MECHANISM SPECIFICALLY WITH THE GOAL OF CATALYZING CLINICAL AND TRANSLATIONAL SCIENCE LOCALLY THROUGH THE SUPPORT OF UNIQUE ACTIVITIES, RESOURCES AND/OR EXPERTISE AT CTSA HUBS. NEXT SLIDE. THE RC2 MECHANISM IS DESIGNED TO SUPPORT LOCALLY HIGH-IMPACT IDEAS OR RESOURCES THAT CAN HELP ACCELERATE BREAKTHROUGHS, STIMULATE RESEARCH AND CUTTING-EDGE TECHNOLOGIES OR FOSTER NEW APPROACHES TO ADVANCE A SPECIFIC AREA. IN THIS CASE, CLINICAL AND TRANSLATIONAL SCIENCE. THIS LOCAL EXPERTISE WILL BE INTEGRAL PART OF THE CTSA INNOVATION ECOSYSTEM WHICH ALREADY INCLUDES MECHANISMS TO SUPPORT COLLABORATIONS BETWEEN CTSA HUBS, THE CTSA COLLABORATIVE INNOVATION AWARDS OR CTIAs, R21 AND U01 MECHANISMS AS WELL AS THE CTSA CONSORTIUM-WIDE CENTERS, RESOURCES FOR RAPID DEMONSTRATION AND DISSEMINATION WHICH WILL BE FUNDED THROUGH A U24 GRANT MECHANISM. THESE PROGRAMS ARE DESIGNED TO STIMULATE THE DEVELOPMENT AND DEMONSTRATION OF UNIQUE EXPERTISE AND RESOURCES LOCALLY. SUCCESSFUL PROGRAMS PRESENTED MODELS AND FURTHER DISSEMINATED TO OTHERS. ALL WITH THE GOAL OF IMPROVING HUMAN HEALTH. NEXT SLIDE. CURRENTLY THROUGH THE CTSA PROGRAM, THE U54 GRANT MECHANISM, NCATS FUNDS OPTIONAL FUNCTIONAL CORES. THESE CORES ARE DESIGNED TO SUPPORT SPECIFIC STRENGTHS AND PROGRAM NEEDS LOCALLY. EACH CTSA HUB CAN SUPPORT UP TO TWO OPTIONAL CORES AS PART OF THE U54 APPLICATION. NEXT CLICK. SOME SAMPLE OPTIONAL CORES, INCLUDE CORES IN LEARNING HEALTH CARE SYSTEM,, REGULATORY SCIENCE AND PRECISION MEDICINE, POPULATION HEALTH AND DISSEMINATION AND IMPLEMENTATION SCIENCE AS WELL AS CORES IN DATA SCIENCE. NEXT CLICK, PLEASE. HOWEVER, THE CURRENT REVIEW AND OPTIONAL CORE SELECTION PROCESS HAD SOME LIMITATIONS. BECAUSE THE REVIEW OF THE AUTOMATIONAL CORE WITHIN THE U54 REVIEW, THERE IS HIGH VARIABILITY IN THE SCIENCE AND TOPICS WHICH MAY NOT NECESSARILY COME WITHIN AREAS OF CRITICAL NEED. THEREFORE AS ONE OF THE COMPONENTS OF THE U54, OPTIONAL CORES DO NOT RECEIVE A SPECIFIC SCORE. FINALLY, SINCE THESE ARE NOT STAND ALONE PROGRAMS AND CAN ALSO BE CHALLENGING TO TRACK AND EVALUATE THOSE INDIVIDUALLY AND OVERALL. NEXT SLIDE, PLEASE. SO IF APPROVED, THE CONCEPT THAT WE ARE PROPOSING TODAY WILL INCORPORATE SUCCESSFUL ASPECTS OF THE U54 OPTIONAL, FUNCTION CORES INTO A LIMITED COMPETITION RC2 FUNDING MECHANISM WITH THE GOAL OF SUPPORTING HIGHLY SPECIALIZED RESOURCES AND CAPABILITIES AND CLINICAL AND TRANSLATIONAL SCIENCE THAT CAN PRODUCE TANGIBLE RESULTS WITH LONG TERM SUSTAINABILITY AND EARLY DISSEMINATION OF SUCCESSFUL RESOURCES IN MIND. AT THE SAME TIME, THIS SUPPORTING MECHANISM WILL ALLOW FOR A STREAMLINED PROGRAM LEVEL TRACKING OF PROGRESS OUTCOMES AND IMPACTS. AND REVIEWED SEPARATELY. PANEL REVIEWERS WITH EXPERTISE IN SPECIALIZED AREAS OF CLINICAL AND TRANSLATIONAL SCIENCE AND TOPICS PROPOSED TO REMAIN A KEY ASPECT. AT THE SAME TIME, PROGRAM WILL HAVE THE ABILITY TO SELECT MOST MERITORIOUS AND HIGHLY INNOVATIVE PROGRAMS WITH THE HIGHEST POTENTIAL TO ADDRESS CRITICAL AREAS OF UNMET NEED. LIMITED COMPETITION MEANS THAT ONLY ACTIVE UM1 HUBS WILL BE ELIGIBLE TO APPLY. NEXT SLIDE, PLEASE. THE FOLLOWING ARE SOME EXAMPLES OF AREAS SPECIALIZED INNOVATION PROGRAMS COULD FOCUS ON. THESE INCLUDE TELEHEALTH, SYSTEMS, REGULATORY SCIENCE, CLINICAL INFORMATICS AND ANALYSTIC TOOLS, GENETICS AND GENOMICS, PRACTICING MALTIC CLINICAL TRIALS AND THE USE OF REAL WORLD EVIDENCE, DISSEMINATION AND IMPLEMENTATION OF NEW THERAPEUTICS AND APPROACHES, INNOVATIVE PROGRAMS ADDRESSING RURAL HEALTH AND HEALTH DISPARITIES, COMMUNITY OUTREACH AND ENGAGEMENT IN THE CLINICAL AND TRANSLATIONAL SCIENCE PROCESS AND OTHER SPECIALIZED PROGRAMS IN RESPONSE TO THE LOCAL NEEDS. NEXT SLIDE. IN SUMMARY, IF APPROVED, THIS CONCEPT WILL HELP SUPPORT SPECIALIZED CTSA HUB RESOURCES, EXPERTISE AND/OR CAPABILITIES WITH THE HIGHEST PROBABILITY TO POSITIVELY IMPACT CLINICAL AND TRANSLATIONAL SCIENCE LOCALLY WITH EARLY DISSEMINATION IN MIND. THE PROPOSED CONCEPT WILL ALLOW FOR A MORE STREAMLINED PROGRAM-LEVEL TRACKING OF PROGRESS OUTCOMES AND IMPACT. NEXT SLIDE. AND WITH THAT, I WILL TURN IT OVER TO THE DISCUSSANTS TO HELP US THINK ABOUT HOW TO IMPROVE THIS INITIATIVE. >> IT'S REALLY CHALLENGING TO UNDERSTAND WHAT EVERYONE IS DOING IN THIS SPACE. IT TOOK A PRETTY HERCULEAN EFFORT FOR US TO PUT TOGETHER A POSTER SESSION WITH OUR COORDINATING CENTER FOR THE CTSAs TO BE ABLE TO SHARE THIS INFORMATION AND LET EACH OTHER KNOW WHAT WAS HAPPENING IN THESE SPACES IT'S A VERY -- IF YOU LOOK AT SOME OF THE OPTIONAL CORE ACTIVITIES THAT ARE HAPPENING WITHIN THE CTSAs RIGHT NOW, THEY ARE VERY EXCITING. THEY ARE VERY INNOVATIVE. I I HAVE LOTS OF STORIES ABOUT HOW THEY HAVE BEEN SO SUCCESSFUL THAT THE INSTITUTION ACTUALLY TAKES THEM ON AS A COMMITMENT SO THAT THE HUBS CAN START PILOTING SOMETHING ELSE THAT THEY WANT TO DEVELOP OR INVEST IN, IN THIS SPACE. AND SO, I UNDERSTAND THAT THE CONS AND THE PROS OF BOTH SITUATIONS OF RETAINING IT WITHIN THE UM1, BUT WE HAVE DONE THAT AND WE REALLY SEE VALUE IN EXTRACTING THOSE AND MAKING THEM MORE VISIBLE FOR OTHERS TO BE ABLE TO ALSO LEARN FROM THESE REALLY, REALLY EXCITING RESEARCH PROJECTS. >> THANKS. AND THE FACT THAT IT'S RESTRICTIVE ONLY TOW CTSAs IS THAT JUST BECAUSE IT WAS IN THERE ORIGINALLY AND WE WANT TO KEEP IT WITHIN THAT FRAMEWORK? DOES THAT -- >> YES. >> DOES THAT STIFLE OTHER PEOPLE COMING IN THAT COULD HAVE IDEAS? THAT'S ONE NEGATIVE TO THAT. >> GO AHEAD MIKE. >> LET ME JUST SAY THAT THAT PRESENTS ONE OPPORTUNITY THAT A INSTITUTION NOT PART OF A CTSA WOULD ACTUALLY MAYBE PRESENT A COLLABORATIVE OR PARTNERING SITUATION FOR THAT CTSA WITH REGARD TO THAT KIND OF PROJECT. WE DO HAVE TO -- WE ARE SENSITIVE TO THE FACT THAT THE LINE ITEM IN OUR BUDGET IS CTSA AND IT'S -- EVERYTHING WE DO IS SUPPOSED TO STAY WITHIN THE CTSA AND SO WE ALWAYS HIGHLIGHT LIMITED COMPETITION WITHIN THE PROGRAM. NOW WITH ADDITIONAL FUNDING, WE COULD THEORETICALLY BRANCH OUT A LITTLE BIT MORE BUT RIGHT NOW, WE'D LIKE TO -- WE REGARD THE CTSA AS A CONSORTIUM SO WE KEEP THE ACTIVITIES WITHIN THE CONSORTIUM. >> THANK YOU. >> BUT I THINK THE OTHER POINT TO EMPHASIZE IS THAT WHILE -- ERICA WENT INTO THE EXPLAINING THE OPTIONAL MODULES BUT WITH LIMITED FLEXIBILITY WITHIN THE BUDGET OF THE CTSA HUB AWARD, THEY DON'T ALWAYS HAVE THE CAPABILITY TO PUT IN AS MUCH RESOURCES INTO THOSE EFFORTS AS POSSIBLE AND WE THOUGHT THIS WOULD ALLOW FOR THE -- AND AGAIN, ONE POINT TO EMPHASIZE, DISTINCT FROM THE RESEARCH PROJECT, THIS IS NOT MEANT TO BE A SPECIFIC PROJECT BUT IS MEANT TO FOCUS ON AN AREA SUCH AS TELEHEALTH, MOBILE TECHNOLOGIES THAT MIGHT INVOLVE A NUMBER OF PROP JECT THAT ARE INTERRELATED WITH ONE ANOTHER, BUILDING OFF ONE ANOTHER IT'S MEANT TO BE MORE EXPANSIVE THAN JUST A SINGLE PROJECT THAT MIGHT BE PROPOSED. >> GREAT. THANK YOU. AND ANDREW TO YOU FOR THE DISCUSSANT. >> SO I DON'T HAVE MUCH TO ADD BEYOND WHAT TED SUGGESTED. I THINK THIS IS A GREAT PROGRAM AND THE IDEA OF SPECIALIZATION MAKES A LOT OF SENSE, PARTICULARLY GIVEN HOW COMPLEX TRANSLATIONAL MEDICINE HAS BECOME AND THE FACT THAT THERE ARE ALL SORTS OF AUXILIARY FIELDS THAT HAVE A LOT TO ADD, INCLUDING COMPUTER SCIENCE AND MECHANICAL ENGINEERING AND A NUMBER OF FIELDS AND THIS ALSO GOES BACK TO MY CONCERN ABOUT THE CLINICAL WORK WE TALKED ABOUT. I THINK IT ALSO UNDERSCORES WHAT DR. JACKSON SAID ABOUT THE FACT THAT THERE ARE A NUMBER OF RESEARCH AREAS THAT DON'T NECESSARILY GET A LOT OF NIH FUNDING BUT COULD BE VERY USEFUL. SO I THINK THIS PROGRAM PROVIDES IN TERMS OF THE ABILITY TO SPECIALIZE IN THESE AREAS A WAY TO ATTRACT THOSE KINDS OF FIELDS. I REALLY THINK THIS IS A GREAT INITIATIVE. THE ONLY SUGGESTION I HAVE ABOUT IMPROVING IT IS SOMETHING I MENTIONED IN PREVIOUS MEETINGS. IN ORDER TO ADVERTISE THIS KIND OF COLLABORATION AND INTERDISCIPLINARY WORK, IT WOULD BE USEFUL TO HAVE SOME COMMENT DEDICATED TO AN ON LINE DISTRIBUTION OF INFORMATION, SOME KIND OF ON LINE LEARNING COMPONENT WHERE YOU PROVIDE SHORT VIDEOS, EVEN ON LINE FOR THESE SPECIALIZED THINGS AND TO MAKE AS MAY BE PART OF THE GRANT, SOME VERY SMALL PORTION DEDICATED TO CREATING EDUCATIONAL MATERIALS THAT NOT NECESSARILY JUST FOR STUDENTS BUT FOR OTHER RESEARCHERS, SO THAT THIS KIND OF SPECIALIZED AREA CAN BE MORE BROADLY DISSEMINATED IN THE ECOSYSTEM. BUT OTHERWISE I THOUGHT IT WAS GREAT. >> OKAY. THANK YOU. AND NOW WE CAN OPEN IT UP TO OTHER COMMENTS. I SEE MA TEEIAS RAISED HIS HAND. >> IT IS ONE OF THE MOST CRITICAL MECHANISMS OF THE CTSA. ONE OF A FEW NATIONAL OUTREACH TOOLS WE HAVE AVAILABLE TO QUICKLY RESPOND LIKE WE DID TO COVID. THE CHALLENGE IS SOMETIMES IT COMES INSTITUTIONAL COSTS AND IF YOU DO THAT AS A FUNDING MECHANISM -- AND IT MIGHT NOT DECIDE TO OPT IN FOR EXAMPLE TO ESTABLISH A SHARE DATA STANDARDS WHICH WILL REQUIRE SOME LOCAL RESOURCES TO DO THAT. AND HOW YOU CAN ADD INCENTIVE TO MAKE SURE THAT THERE IS STRONG SUPPORT ACROSS THE DIFFERENT CTSAs TO ENGAGE WHICH ARE PARTICULAR IMPORTANT FOR PATIENT HEALTH. >> THANK YOU. THAT'S A GREAT COMMENT. IT LOOKS LIKE PAULA HAD A COMMENT IN THERE ABOUT REVIEWER EXPERTISE. PAULA, DO YOU WANT TO MAKE A COMMENT ON THAT? >> I SECOND THE IDEA THAT HAVING EVERYONE PUT THEIR OWN CORE INTO THE UL1 NOW MAKES IT VERY DIFFICULT FOR REVIEWERS TO HAVE APPROPRIATE EXPERTISE. SO THIS IS A WAY AND THIS ALSO MIGHT HELP WITH THE IDEA OF ONE OF THE CORE IDEAS OR THE -- COULD BE PARTNERING WITH MIT OR WHATEVER TO MAYBE FILL IN SOME GAPS THAT MIGHT VERY WELL BE FROM OUR PRIOR CONVERSATION WITH THE UM1 TO KIND OF PUT THINGS IN ALL THE DIFFERENT AREAS OF THE TRANSLATIONAL SPECTRUM AND KNOWING THE CTSAs AND THE INSTITUTIONS MOST LIKELY WILL HAPPEN. >> OKAY. >> THAT'S A GREAT SUGGESTION, PAULA. REALLY GREAT -- REALLY SECURES THE CRITICAL EXPERTISE WITH SOME OF THOSE INSTITUTION THAT IS DO WANT TO PARTICIPATE BUT IT DOES IT IN A VERY PROACTIVE MANNER. >> AS WELL AS POTENTIALLY HITTING THAT OTHER SIDE WHERE YOU HAVE GOT ALL OF THESE CLINICS AND THAT WOULD GIVE YOU ACCESS TO CLINICAL POPULATIONS BUT THEY DON'T HAVE NIH FUNDING. SO A SPECIAL CORE THAT REACHES OUT TO FEDERALLY-QUALIFIED HEALTH CENTERS OR SOMETHING LIKE THAT. IT WOULD ALSO BE SOMETHING THAT YOU WOULD SEE VERY MUCH IN THE RUBRIC. >> THANK YOU. BECKY JACKSON, YOU HAVE A COUPLE OF COMMENTS IN THE CHAT BOX SO I'LL LET YOU GO AHEAD AND RELAY THOSE. >> I THINK I'LL START WITH THE SECOND ONE FIRST. SO WHEN I THINK THROUGH THE MATH AND THE BUDGET THAT WE NOW HAVE FROM USED TO BE A UL1 AND A KL2, WE NOW HAVE KIND OF SPLIT THIS OUT TO A UM1, RC2, INDEPENDENT K12, AND I'LL SAY THE TL1 HAD A DIFFERENT BUDGET LINE SO IT WASN'T THE SAME. MY QUESTION -- AND THEN THE SHORT SUMMER EXPERIENCE ONE, WHICH I CAN'T REMEMBER THE NUMBER OF. SO I GUESS MY QUESTION IS, HOW CAN YOU DEAL WITH THE FUNDING FOR ALL OF THESE PROGRAMS AND YET SAY THAT WE'LL TRY TO KEEP THE UM1 WITHIN 5% OR SO OF WHERE IT CURRENTLY FITS? SO I'M JUST TRYING -- HAVING TROUBLE THINKING, ARE WE GOING TO HAVE SUFFICIENT FUNDING TO HAVE AN IMPACT WITH THIS PROGRAM? THEY ARE ASKING FOR A DOLLAR AMOUNT BUT HOW ABOUT THINKING ABOUT BALANCING THESE? >> UNDERSTOOD. SO A COUPLE OF THINGS. KEEP IN MIND THAT THE RC2s WILL BE DELAYED RELATIVELY ONE YEAR SO THEY WON'T GO AT THE SAME TIME. SECONDLY, IT WILL OHM BE ELIGIBLE TO UM1 AWARDEES SO IT WILL BE PHASED IN OVER TIME AND WHAT WE PROJECTED IS THAT OUR ANTICIPATED -- AGAIN USING WHAT THE BUDGET PEOPLE TELL ME IS THE OFFICIAL PROFESSIONAL JUDGMENT OF WHAT WE ARE ALLOWED TO PROJECT, THAT OUR ANTICIPATED BUDGET GROWTH OVER THE NEXT FIVE YEARS WILL BE ABLE TO ABSORB A SIP PROGRAM THAT ENDS UP BEING RELATIVELY COMPARABLE TO THE TOTAL -- PERCENTAGE OF OPTIONAL MODULES WE SEE IN THE PROGRAM. SO WE WILL GROW TOWARDS THAT NUMBER OVER TIME. >> AND I THINK WE HAVE -- LET'S SEE. I THINK MARSHAL WAS THE NEXT ONE THAT I SAW. I'M SORRY, KEITH MUELLER. DID YOU WANT TO RELAY YOUR COMMENT OR WAS IT ADDRESSED ALREADY? >> MOSTLY ADDRESSED AND THEN THEY WERE JUST COMMENTS NOT QUESTIONS. >> GOT IT. THANK YOU SO MUCH. AND I BELIEVE THE NEXT ONE WAS MARSHAL. MARSHAL, YOU HAD A COMMENT AS WELL. I WANT TO MAKE SURE WE ADDRESS THAT. >> JUST AN EASY THING. IS THERE A DISSEMINATION MECHANISM FOR THAT LOCAL GRANT COMES UP WITH SOMETHING WONDERFULLY USEFUL THE REST OF THE NETWORK WOULD BENEFIT FROM? >> SO MARSHAL, WHAT WE ARE NOT TALKING ABOUT HERE IS SOME OF OUR MORE CONSORTIUM-WIDE ACTIVITY. SO WHAT WE HAVE RIGHT NOW IS THE CONSORTIUM-WIDE RESOURCE RESEARCH CENTERS. AND THAT IS SOMETHING THAT SOMEONE COULD, WITH A SUCCESSFUL SIP FIVE YEARS FROM NOW OR SEVERAL YEARS FROM NOW WITH THE CONCEPT THAT REALLY LOOKS LIKE IT IS RIPE FOR DISSEMINATION, IS THAT GROUP COULD COLLABORATE WITH A NUMBER OF OTHER CTSAs AND PUT IN FOR A R2D2 SPECIFICALLY FOCUSED ON DISSEMINATION AND IMPLEMENTATION OF WHATEVER COMES OUT OF THAT. >> IF YOU HAD SOME SORT OF SHOWCASE FOR THOSE SMALL PROJECTS GOING ON, PEOPLE MIGHT FIND OPPORTUNITIES. >> AND WHAT WE HAVE SEEN IS THAT HAS BEEN DONE IN A NUMBER OF INSTANCES WITH THE CCIAs, COLLABORATIVE AWARDS WE SEEN WHERE SOMETHING THAT HAS BEEN DONE AT ONE INSTITUTION AS PART OF A PILOT OR IN CONJUNCTION WITH ANOTHER NIH-IC, THEY THEN COME IN LATER ON WITH A NUMBER OF OTHER INSTITUTIONS FOR CCIA TO DEMONSTRATE THEY CAN DO THE SAME THING AT OTHER INSTITUTIONS. I THINK IT IS ONE OF THE REAL RATE LIMITING STEPS IN DISSEMINATION IS THAT PEOPLE JUST DON'T KNOW IF IT'S GOING TO BE TRANSLATABLE PHYSICALLY, NOT JUST TRANSLATABLE IN TERMS OF WHAT WE CALL TRANSLATION. BUT IT WORKED AT YOUR INSTITUTION BUT WILL IT WORK AT MINE? THAT IS WHAT THIS -- THERE ARE A NUMBER OF CCIA PROJECTS SPECIFICALLY AROUND DOING SPECIFICALLY THAT. >> AND TO THAT POINT, WE ARE RELAYING A VARIETY OF CTSA CONCEPTS HERE BUT THERE IS ALSO ANOTHER SUITE OF OTHER CTSA PROGRAMS AS WELL THAT ARE CURRENTLY ONGOING. SO THIS IS JUST REPRESENTATIVE OF THE CONCEPT CLEARANCES THAT WE ARE HOPING TO CONDUCT HERE TODAY. SO MAYBE AT SOME POINT IT WOULD BE GOOD FOR PROBABLY THE NEXT COUNCIL, I BELIEVE, THAT MIKE WOULD RELAY THE BROADER WAY THAT THE CTSAs FUNCTION AND THAT WILL ALSO HELP. SO THESE ARE GREAT QUESTIONS AND YOU'RE DEFINITELY TRACKING WITH THE WHOLE IDEA. WE ARE GOING TO GO AHEAD AND MOVE ON TO THE NEXT CONCEPT. WE HAVE GOTTEN THROUGH ALL OF THESE QUESTIONS AND SO WE'LL GO AHEAD AND MOVE TO THE NEXT CONCEPT FOR THE CTSA PROGRAM CENTER CAREER TRAINING AND RESEARCH EDUCATION AWARDS. I'M GOING TO TURN THIS OVER TO MERCEDES. >> GOOD AFTERNOON. HOPEFULLY YOU CAN HEAR ME. MY NAME IS MERCEDES. AND I'M THE PROGRAM OFFICER IN THE DIVISION OF CLINICAL INNOVATION AND I'M PRESENTING AN OVERVIEW OF THE CAREER TRAINING AND RESEARCH EDUCATION CONCEPTS FOR THE CTSA PROGRAM. NEXT SLIDE, PLEASE. THE CTSA PROGRAM CREATES AN ENVIRONMENT OF EXCELLENCE AND INNOVATION THAT PROMOTES TRAINING AND CAREER DEVELOPMENT AND NURTURES THE FIELD OF TRANSLATIONAL SCIENCE THAT IN TURN INSURES THE DEVELOPMENT OF A 21ST CENTURY WORKFORCE CAPABLE OF ADVANCING CLINICAL AND TRANSLATIONAL SCIENCE. ONE WAY THIS IS ACCOMPLISHED IS THROUGH THE SUPPORT OF TRAINING AND CAREER DEVELOPMENT OPPORTUNITIES. THE NATIONAL SERVICE TRAINING GRANT, TL1 HIGHLIGHTED ON THE SLIDE, SPARRED UNDERGRADUATES, GRADUATES AND POSTDOCTORAL FELLOWS WITH A GOAL OF PREPARING TRAINEES TO ADVANCE DIAGNOSTIC THERAPEUTICS, CLINICAL INTERVENTIONS AND BEHAVIORAL MODIFICATIONS THAT IMPROVE HEALTH. THE MEPPED TO CAREER DEVELOPMENT AWARD, THE KL2, SUPPORTS LATER-STAGE POSTDOCTORAL FELLOWS AND JUNIOR FACULTY PREPARING THEM FOR RESEARCH CAREERS IN CLINICAL AND TRANSLATIONAL RESEARCH. NEXT SLIDE, PLEASE. INPUT FROM STAKEHOLDERS ON ENHANCING WORKFORCE DEVELOPMENT OPPORTUNITIES FOR THE CTSA PROGRAM, INCLUDED THE NEED FOR INCREASED FLEXIBILITY, THE SEPARATION OF REVIEW AND SCORES FOR THE CAREER AND TRAINING APPLICATIONS, SOME CALL FOR THE NEED TO ALIGN CAREER AND TRAINING AWARDS WITH THE ACADEMIC CALENDAR AND THE OPPORTUNITY TO EXPAND AND ENHANCE LEARNING. IN RESPONSE, NCATS PROPOSES TO SEPARATE THE CAREER AND TRAINING APPLICATION FROM THE HUB AS IT IS ALREADY MENTIONED, AND THIS WOULD ALLOW SEPARATE REVIEW AND SCORES AND START DATES THAT MAY ALIGN WITH THE ACADEMIC CALENDAR. BICEP RATING THE TRAINING OPPORTUNITIES FOR PRE-DOCTORAL, POSTDOCTORAL AND THE SHORT TERM TRAINING, INSTITUTIONS CAN BUILD UPON THEIR STRENGTHS. THEY WILL BE ABLE TO MEET LOCAL TRAINING AND CAREER DEVELOPMENT NEEDS IN CLINICAL AND TRANSLATIONAL SCIENCE RESEARCH. AND THEY WILL BE ABLE TOL ENHANCE RESEARCH OPPORTUNITIES AT DIFFERENT CAREER LEVELS AND AT PARLOR INSTITUTIONS. FOR THIS CONCEPT CLEARS, ALL ACTIVITIES OF THE CURRENT CAREER TRAINING RESEARCH EDUCATIONAL EFFORTS ARE RETAINED. THIS INCLUDES THE NUMBER OF TRAINEES AND THE CURRENT INVESTMENT. WHILE OFFERING FLEXIBILITY TO ENHANCE AND CUSTOMIZE THE CAREER TRAINING AND RESOURCE EDUCATION OPPORTUNITY THAT SYNERGIZED THE LEVERAGE LOCAL STRENGTHS AND NEEDS. NEXT SLIDE. WITH THIS IN MIND, FOUR LIMITED COMPETITION CONCEPTS FOR THE CAREER TRAINING AND RESEARCH EDUCATIONAL OPPORTUNITIES ARE PROPOSED. THESE ARE TWO NRSA, ONE AT THE POSTDOCTORAL AND ONE AT THE PRE-DOCTORAL LEVEL. AND INSTITUTIONAL MENTOR CAREER DEVELOPMENT AWARD, THE K12, AND A RESEARCH EDUCATION GRANT, THE R25. THE GOAL OF THE PRE-DOCTORAL T32 IS TO PREPARE GRADUATE PRE-DOCTORAL TRAINEES TO ADVANCE DIAGNOSTIC THERAPEUTICS, CLINICAL INTERVENTIONS THROUGH MODIFICATION THAT IS IMPROVE HEALTH IN CLINICAL AND TRANSLATIONAL SCIENCE. THE EXPECTATION OF THE POSTDOCTORAL T32 IS FOR EARLY-STAGE POSTDOCTORAL TRAINEES TO BE POISED TO ADVANCE CLINICAL AND TRANSLATIONAL SCIENCE. THIS CONCEPT CLEARANCE FOR THE T32 REMAINS OPTIONAL. THE INSTITUTIONAL MENTOR CAREER DEVELOPMENT AWARD, K12, PROVIDES PROTECTED TIME TO PROMISING LATER-STAGE FELLOWS AND JUNIOR FACULTY SCHOLARS AND PREPARES THEM FOR INDEPENDENT RESEARCH CAREERS IN CLINICAL AND TRANSLATIONAL SCIENCE. FOR THIS CONCEPT CLEARANCE, THE K12 OPPORTUNITY REMAINS REQUIRED. THE EXPECTATION FOR THE RESEARCH EDUCATION GRANT, R25, IS TO PROVIDE SHORT TERM RESEARCH OPPORTUNITIES FOR INDIVIDUALS FROM A RANGE OF CAREER STAGES FROM THE UNDERGRADUATE LEVEL THROUGH JUNIOR FACULTY. THE R25 CONCEPT EXPECTS TO BUILD RESEARCH OPPORTUNITIES AT LEVELS IN WAYS THAT ENHANCE EXPONENTIAL LEARNING BEYOND INDUSTRY. FOR THIS CONCEPT CLEARANCE, THE R25 OPPORTUNITY WILL BE OPTIONAL OPTIONAL. BY ENHANCING CAREER TRAINING AND RESEARCH EDUCATIONAL OPPORTUNITIES FOR THE CTSA PROGRAM, WE ALLOW FOR FLEXIBILITY AND ENCOURAGE TO BUILD ON LOCAL STRENGTHS AND ENHANCE OPPORTUNITIES, ENCOURAGE CUSTOMIZATION WITH AN EYE TOWARDS ADDRESSING NEEDS IN THE CLINICAL AND TRANSLATIONAL PATHWAY AND OFFER MULTIPLE ON RAMPS FOR INDIVIDUALS INTERESTED IN CLINICAL AND TRANSLATIONAL SCIENCE. NEXT SLIDE. I WANT TO HIGHLIGHT AREAS OF EMPHASIS ACROSS THESE CONCEPTS. FIRST, THE DEVELOPMENT OF THE CHARACTERISTICS OF A TRANSLATIONAL SCIENTIST IS AN EXPECTATION ACROSS ALL OF THESE. THESE CHARACTERISTICS ARE NOTED HERE IN THE INFO GRAPHIC AND THESE CHARACTERISTICS INCLUDE RIGOROUS RESEARCHER, PROCESS INNOVATOR AND DOMAIN EXPERT, JUST TO NAME A FEW. PROMOTING DIVERSITY AT ALL LEVELS FROM THE KIND OF SCIENCE TO THE REASON IN WHICH IT IS CONDUCTED, TO THE BACKGROUND OF THE INDIVIDUALS TO THE TYPES OF INSTITUTIONS, DIVERSITY AT ALL LEVELS IS NEEDED TO ADDRESS COMPLEX CLINICAL AND TRANSLATIONAL SCIENCE PROBLEMS AND STRENGTHEN THE CLINICAL AND TRANSLATIONAL SCIENCE RESEARCH ENTERPRISE. WE EXPECT THE USE OF EVIDENCE INFORMED PRACTICE, EFFECTIVE MENTORING IS ASSOCIATED WITH AND NOT LIMITED TO INCREASED EFFICACY, SELF-EFFICACY, EDUCATIONAL AND CAREER SATISFACTION, CAREER ADVANCEMENT AND RESEARCH PRODUCTIVITY. FINALLY, WE ENCOURAGE THAT EXCELLENCE IN INNOVATION -- WE RECOGNIZE THAT EXCELLENCE AND INNOVATION COMES FROM INDIVIDUALS ACROSS A TRANSLATIONAL SPECTRUM. WE EXPECT THAT TRAINEES AND SCHOLARS WILL BE EXPOSED TO A FULL RANGE OF WORKFORCE OPPORTUNITIES IN CAREERS IN CLINICAL AND TRANSLATIONAL SCIENCE. THROUGH THESE CONCEPTS, WE EXPECT THAT THE 21ST CENTURY CLINICAL AND TRANSLATIONAL SCIENCE WORKFORCE WILL BE IN THE POSITION TO ADDRESS ROAD BLOCKS THAT CURRENTLY LIMIT EFFICIENCY AND EFFECTIVENESS OF THE CLINICAL AND TRANSLATIONAL SCIENCE RESEARCH ECOSYSTEM. NEXT SLIDE. I WILL BE PRESENTING THE CONCEPT CLEARANCE FOR THE NRSA INSTITUTIONAL PREDOCTORAL AND POSTDOCTORAL RESEARCH TRAINING OR T32, BUT I WON'T BE THE ONLY ONE PRESENTING THESE CONCEPTS. I'M JOINED BY DR. JOAN WHO WILL PRESENT THE CONCEPT CLEARANCE FOR INSTITUTIONAL CAREER DEVELOPMENT AWARD OR THE K12. AND THEN DR. JAMIE WHO WILL PRESENT THE CONCEPT CLEARANCE FOR THE RESEARCH EDUCATION PROGRAM OR THE R25. THANK YOU. >> THANK YOU MERCEDES. THAT IS A GREAT OVERVIEW AND I THINK YOU CAN JUST GO AHEAD AND GO INTO THE NEXT CONCEPT AND WE'LL HOLD THE DISCUSSION AFTER WE HAVE THE CONCEPT THAT WE ARE DISCUSSING. SO GO AHEAD AND MOVE FORWARD. >> SO I'M BACK. NEXT SLIDE, PLEASE. THIS CONCEPT PROPOSES TWO STAND ALONE NATIONAL RESEARCH SERVICE AWARD INSTITUTIONAL TRAINING GRANTS. T32 PRE DOCKETAL AND T32 POSTDOCTORAL AS PART OF THE SUITE OF THE CAREER TRAINING AND RESEARCH EDUCATION CONCEPT FOR THE CTSA PROGRAM. THE T32 CONCEPT REMAINS OPTIONAL AS IS HIGHLIGHTED BY THE DASHED BOXES HERE. NEXT SLIDE. THE TL1 PROGRAMS ARE COMPRISED OF POSTDOCTORAL, PRE DOCTORIAL AND SHORT TERM SUMMER TRAINEE POSITIONS. IN FISCAL YEAR 20, THERE WERE 181 POSTDOCTORAL TRAINEES, 305 PRE DOCTORIAL TRAINEES AND 34 SHORT TERM/SUMMER TRAINEE POSITIONS. THE OBJECTIVE OF THIS CONCEPT IS TO ENHANCE TRAINING AND RESEARCH EDUCATION OPTIONS SO THAT LEVERAGE POOL OF CANDIDATES AND CUSTOMIZE RESEARCH TRAINING OPPORTUNITIES. THIS WOULD ALLOW FOR THE HUBS TO BUILD ON THEIR STRENGTHS AND PROVIDE QUALITY RESEARCH TRAINING IN CLINICAL AND TRANSLATIONAL SCIENCE. THE EXPECTATION IS FOR TRAINEES TO RECEIVE A TRANSDISCIPLINARY RESEARCH TRAINING THAT IMPARTS WITH AN UNDERSTANDING OF THE TRANSLATIONAL SPECTRUM AS A WHOLE. TRAINEES ARE EXPECTED TO GAIN SKILLS AND CHARACTERISTICS OF SUCCESSFUL TRANSLATIONAL SCIENTISTS AND THESE CHARACTERISTICS INCLUDE BUT ARE NOT LIMITED TO, SYSTEM THINKER, TEAM PLAYER, AND BOUNDARY CROSSER. MENTORING IS A KEY FEATURE OF A T32 RESEARCH TRAINING CONCEPT AND THE INCLUSION OF EVIDENCE INFORMED MENTORING PRACTICES EXPECTED. THE EXPECTATION IS FOR NRSAT32 TRAINEES, PRE-DOC AND POSTDOC, TO BE EXPOSED TO MANY CAREER PATH OPTIONS AVAILABLE IN THE CLINICAL AND TRANSLATIONAL AREA. THEY CAN GO TO A VARIETY OF WORKFORCE AREAS, MENTIONED PREVIOUSLY, INSIDE ACADEMIA, OUTSIDE ACADEMIA, WE WANT TO SEE THESE INDIVIDUALS BOTH TO WHERE THEIR PASSION TAKES THEM AND THEY COULD BE PREPARED FOR ANY OF THESE WORKFORCE SECTORS. IN OUR VIEW, THESE ARE ALL PLACES WHERE TRAINEES CAN FLEX THEIR CLINICAL AND TRANSLATIONAL SCIENCE MUSCLES AND SHOWCASE TO A BROAD AUDIENCE OF CLINICAL AND TRANSLATIONAL SCIENCE AND IMPROVE THE HEALTH OF INDIVIDUALS AND THE PUBLIC. SINCE WE EXPECT TO SEE INNOVATIONS AT THE POSTDOCTORIAL STAGE, LEADERSHIP AND MANAGEMENT TRAINING IS EXPECTED THESE INDIVIDUALS NEED TO BE READY TO STEP INTO LEADERSHIP AND MANAGEMENT POSITIONS. THIS CONCEPT ENHANCES CAREER AND TRAINING EDUCATIONAL OPPORTUNITIES AVAILABLE TO CLINICAL AND TRANSLATIONAL SCIENCE WORKFORCE. THIS CONCEPT SUPPORTS NCATS STRATEGIC GOAL NUMBER 3, TO DEVELOP AND FOSTER INNOVATIVE TRANSLATIONAL TRAINING IN A HIGHLY SKILLED AND DIVERSE TRANSLATIONAL WORKFORCE. THE CTSA PROGRAM HUB CREATES AN ENVIRONMENT OF EXCELLENCE AND INNOVATION. THIS CONCEPT ALLOWS FOR THE CUSTOMIZATION OF A CAREER IN TRAINING EDUCATIONAL OPPORTUNITIES CONSISTENT WITH THE LOCAL POOL OF CANDIDATES AND THE LOCAL TRAINING NEEDS AND WILL STRENGTHS. THE KEY IS TO IDENTIFY THE STRONGEST POOL, WHERE THE STRONGEST POOL IS AND WHERE THE BRIGHTEST IMPACT CAN BE MADE. IF THE STRONGEST POOL IS IN THE PREDOCTORAL LEVEL, THEN HUBS CAN CUSTOMIZE THEIR T32 TRAINING TRAINING EFFORTS AND ENERGY IN THIS SPACE T IS POSSIBLE THE HUBS MAY WANT TO ENHANCE RESEARCH TRAINING EFFORTS BY LEVERAGING BOTH THE T32 CONCEPTS AND THESE CONCEPTS MAKE IT POSSIBLE. THE GOAL IS TO ENSURE THAT THE DEVELOPMENT OF THE 21ST CENTURY WORKFORCE IS CAPABLE OF ADVANCING TRANSLATIONAL SCIENCE. NEXT SLIDE. WITH THIS, I TURN OVER TO THE DISCUSSANTS FOR COMMENTS AND QUESTIONS. WITH A PARTICULAR EYE TOWARDS HOW WE CAN IMPROVE THIS INITIATIVE. THANK YOU VERY MUCH. >> THANK YOU VERY MUCH MERCEDES AND FOR THIS PARTICULAR CONCEPT, WE HAVE PAULE HARRIS AND KEITH. SO PAULE OR KEITH, MAYBE PAULE YOU CAN GO FIRST? >> SURE. THANK YOU FOR THE PRESENTATION, MERCEDES. I'M JUST TRYING TO MAKE SURE I HAVE GOT MY HEAD AROUND THIS. SO BASICALLY THE T32, WE ARE GOING TO DO A LIFT AND SHIFT. IT'S GOING TO BE BROKEN APART FROM THE PARENT BUT WE ARE KIND OF LIFTING AND SHIFTING FROM THE UL1 MECHANISM WHICH IS VERY T32-LIKE TO THE T32. IS THAT THE NET EFFECT OF WHAT WE ARE TALKING ABOUT HERE? >> YES, BEING VERY EQUAL. AND REALLY NOTHING HAS CHANGED. >> RIGHT. THAT IS WHAT IT SEEMED LIKE TO ME. SO THE ONEY REQUEST I HAVE, THE ONE OTHER QUESTION I HAVE WOULD BE, IN YOUR PROJECTED MODELING, ARE YOU ANTICIPATING THAT THE CTSA PROGRAM AS A WHOLE WOULD HAVE BASICALLY EQUIVALENT NUMBER OF TRAINEES THEY DO UNDER THE OLD PROGRAM? >> YES. WE ARE COMMITTED TO KEEPING THE SAME NUMBER OF TRAINEES WE HAVE AS FUNDS GROW IN THE CTSA WORLD, WE WILL REVISIT THOSE NUMBERS AS WELL. BUT AT THE MOMENT, WE ARE HOLDING EVERYTHING AS WE ARE. NO LOSS. >> OKAY. THANK YOU, PAULE. KEITH DO YOU HAVE ANY COMMENTS? >> JUST A COUPLE. ONE IS THE -- I LIKE THE EMPHASIS THAT IS MULTIDISCIPLINARY AND SO THE TERMINOLOGY THAT YOU WERE USING IS ABOUT COVERING THERAPEUTIC, CLINICAL AND BEHAVIORAL. I'M WONDERING IF THE PROGRAM AGGREGATES SO WE HAVE SOME KNOWLEDGE OF HOW MANY PARTICIPANTS FROM VARIOUS DISCIPLINES, PARTICULARLY THROUGH -- PARTICULARLY INTERESTED IN THE T32 FOR DIVERSITY ACROSS DISCIPLINES, DIVERSITY ACROSS RACE ETHNICITY CATEGORIES AND THEN DIVERSITY IN WHERE THEY END UP. AS YOU SAY, YOU WANT TO MAKE SURE THEY UNDERSTAND THERE ARE DIFFERENT OCCUPATIONAL TRACKS. SO I'M WONDERING ABOUT DATABASES THAT YOU HAVE THAT LET US KNOW OF HOW MUCH DIVERSITY WE HAVE ACTUALLY SEEN. >> I THINK THAT IS GOING TO BE ONE OF THE STRENGTHS OF TAKING THESE PIECES OF THE PUZZLE APART. IT WOULD ALLOW FOR BETTER TRACKING. IT GETS A LITTLE MESSY GIVEN HOW IT IS BUNDLED. SO THAT IS ONE OF THE THINGS WE WILL BE ABLE TO BETTER BE ABLE TO TRACK SOME OF THESE THINGS. SO THANK YOU FOR THAT QUESTION. THAT IS ON OUR RADAR. >> AND THEN AT SOME POINT, THAT CAN BECOME STRONGER AND STRONGER AS CRITERIA FOR JUDGING THE APPLICANTS FOR THE T32? >> INDEED. >> THANK YOU. >> OKAY. -- [ MULTIPLE SPEAKERS ] I SEE A QUESTION FROM PAULE THAT LOOKS LIKE IT MIGHT HAVE BEEN ADDRESSED. PAULA DO YOU HAVE ANYTHING TO ADHERE? >> WELL, WE HAVE LIKE A FREESTANDING PROGRAM AND I USED TO BE A PROJECT COORDINATOR AND THEN DEPENDING UPON THE SIZE, HOW MANY PRE OR POST DOCKS, YOU GET PIECES OF PROJECT COORDINATORS. SO SOMETIMES WITH THE T32 AWARD THAT HAS BOTH PRE AND POST DOCKS, THE ADMINISTRATION IS SMALLER RATHER THAN HAVING TWO SEPARATE PROGRAMS. AND WONDERING IF WE COULDN'T CUT ADMINISTRATIVE COSTS BY COMBINING OR HAVING THE OPTION TO COMBINE WITH DIFFERENT SIZES OF PROGRAMS. IN THERE IS A LOT OF WAYS TO CUT AND PARSE THIS SO JUST THINKING ABOUT MORE MONEY GOING TO TRAINING AND LESS TO ADMINISTRATIVE OVERHEAD. >> THANK YOU FOR THAT. WE'LL TAKE THAT INTO CONSIDERATION. BUT I APPRECIATE THAT. THANK YOU. >> AND ANNIE, YOU HAVE A COMMENT AS WELL. DO YOU WANT TO RELAY IT? >> SURE. I'M NOT SURE IF THIS IS SOMETHING THAT IS ALREADY DONE OR NOT BUT WONDERING IF THE TRAINING GRANTS ARE EVER TAILORED TO HELP SPUR DEVELOPMENT IN AREAS OF UNMET NEED IN PLACES WHERE NCATS IS ALREADY TRYING TO SPUR DEVELOPMENT? SO FOR EXAMPLE IN THE ULTRARARE FIELD, NUMBER OF TRAINING GRANTS THOUGHT OUT TO INCENTIVIZE TRAINEES TO GO INTO THOSE FIELDS AND SO ON? >> I THINK IF THE STRENGTHS OF THAT HUB IS SOMETHING LIKE THAT, THE PROGRAM T32 COULD BE WITH THAT INTENT. I THINK THERE IS A LOT OF POSSIBILITIES THERE BUT IN PLACE OF LOCAL STRENGTHS OF THE HUBS. >> SO IF NONE OF THE HUBS ARE IDENTIFYING AS HAVING STRENGTHS IN THOSE AREAS, WE WOULD BE INCENTIVIZING TRAINING DEVELOPMENT IN THOSE SPACES? >> HOW PEOPLE ARE THINKING ALONG THESE THINGS, WHAT IS MISSING AND WHAT THEY CAN CONTRIBUTE? BUT WE'LL THINK ABOUT THAT. SO I APPRECIATE THE COMMENT. >> ONE OTHER POINT TO EMPHASIZE, ANNIE, IS WE HAVE OTHER OPPORTUNITIES INDEPENDENT OF WHAT WE ARE TALKING ABOUT HERE THAT CAN ADDRESS THAT. SO WE HAVE DIVERSITY AND RE-ENTRY SUPPLEMENTS THAT CANDIDATES CAN COME IN AND BE FOCUSED ON SOME OF THE TYPES OF AREAS THAT YOU'RE TALKING ABOUT AND IN ADDITION, WE HAVE SEEN OTHER ICs UTILIZE ANOTHER NIH PROGRAM THAT WE PARTICIPATE IN WHICH IS A LOAN REPAYMENT PROGRAM, SPECIFICALLY HIGHLIGHT AREAS WHERE WE LIKE TO SEE MORE EFFORT AND WE BASICALLY USE THE CARROT OF LOAN REPAYMENT FOR INDIVIDUALS. SO THERE ARE A NUMBER OF OTHER MECHANISMS THAT CAN TARGET, MORE SELECTIVE IN TERMS OF TARGETING WHAT WE ARE TRYING TO LOOK AT. >> IT'S A VERY RICH AND DIVERSE PORTFOLIO AND THE INSTITUTIONS DO INVEST IN THE TRANSLATIONAL SPECTRUM WHERE THEY SEE THEIR STRENGTHS. AND ALSO THEIR NEEDS TOO. I HAVE A TEAM THAT IS FOCUSED ON CLINICAL INFORMATICS. SO IT'S A REALLY RICH AND DIVERSE PORTFOLIO. >> THANK YOU VERY MUCH FOR THAT DISCUSSION. WE ARE GOING TO GO AHEAD AND MOVE ON TO THE NEXT CONCEPT CLEARANCE FOR THE INSTITUTIONAL CAREER DEVELOPMENT AWARD. K12. SO I'M GOING TO TURN IT OVER TO JOAN. >> IS. >> GOOD AFTERNOON. CAN YOU SEE ME? >> YES. >> GREAT. THANK YOU VERY MUCH MERCEDES. THANK YOU COUNCIL MEMBERS. APPRECIATE ALL OF THE LIVELY DISCUSSIONS TODAY. MY NAME IS JOAN NAGEL, A PROGRAM DIRECTOR HERE WITHIN THE DIVISION OF CLINICAL INNOVATION OF NCATS. AS YOU HEARD FROM MIKE, ERICA, MERCEDES AND THE OVERVIEW, THESE ARE A SUITE OF EDUCATIONAL OPPORTUNITIES THAT WE LIKE TO SHOWCASE TODAY. NEXT SLIDE. IN THIS GRAPHIC, YOU SEE THE INSTITUTIONAL CAREER DEVELOPMENT AWARD OR K12 IS FOCUSED ON SUPPORTING THE RESEARCH AND CAREER DEVELOPMENT OF MID TO LATE POSTDOCS AND JUNIOR FACULTY WHO ARE COMMITTED TO A CAREER IN CLINICAL AND TRANSLATIONAL SCIENCE RESEARCH AND ARE ABLE AND POISED TO TAKE ON LEADERSHIP POSITIONS. THIS CONCEPT AS YOU HEARD EARLIER, INCLUDES DIVERSITY AS A RECURRENT THEME THROUGHOUT, INCLUDING THE RECRUITMENT OF SCHOLARS FROM UNDER REPRESENTED GROUPS IN THE BIOMEDICAL AND BEHAVIORAL RESEARCH WORKFORCE AND INDIVIDUALS WITH DISABILITIES AND THOSE FROM DISADVANTAGED BACKGROUNDS. SO THE CURRENT INSTITUTIONAL CAREER DEVELOPMENT PROGRAM, OTHERWISE KNOWN AS KL2 OR THE LINKED AWARD, OFFERS POSTDOCTORAL SCHOLARS AND JUNIOR FACULTY WHO ARE COMMITTED TO RESEARCH INTENSIVE TENURED TRACK EXPERIENCE, ADVANCED TRAINING IN CLINICAL AND TRANSLATIONAL SCIENCE RESEARCH. IN FISCAL YEAR 20, THERE WAS 60 PROGRAMS THAT HAD 332 SCHOLARS, POSTDOCTORAL SCHOLARS AND JUNIOR FACULTY WHO WERE BEING TRAINED. THE KL2 OFFERS PROTECTED TIME, 75% PROTECTED TIME, SALARY, RESEARCH SUPPORT AND MULTIDISCIPLINARY MENTORING TO SUPPORT THE TRANSITION TO RESEARCH INDEPENDENCE. NEXT SLIDE. SO AGAIN WE LIKE TO REITERATE THAT THIS CONCEPT WILL RETAIN THE FEATURES OF THE CURRENT INSTITUTIONAL CAREER DEVELOPMENT PROGRAM OR CL2. THIS IS A D LINKING WITH SOME AREAS OF EMPHASIS THAT I WON'T GO THROUGH NOW. FIRST OF ALL, AS YOU HEARD AS MIKE AND ERICA HIGHLIGHTED, WE ARE PLANNING TO PROMOTE FLEXIBILITY UNDER THIS CONCEPT TO CUSTOMIZE THE CAREER DEVELOPMENT IN EDUCATION OPPORTUNITIES THAT ARE OFFERED TO ALIGN WITH LOCAL INSTITUTIONAL STRENGTHS AND RESOURCES. AND AGAIN, I KNOW THAT THIS QUESTION CAME UP ALSO DURING THE CHAT, THIS ISSUE OF HAVING THE LOCAL FLAVOR. AND SO THIS CONCEPT WILL ALLOW FOR TAILORING THE K12 TO THOSE LOCAL FLAVOR, TO THE LOCAL UNMET NEEDS. ANOTHER AREA OF EMPHASIS IS OFFERING FLEXIBLE INNOVATIVE LEARNING MODELS TO ENGAGE SCHOLARS IN TEAM SCIENCE AND TEAM SCIENCE TRAINING. HOW TO MANAGE TEAMS, INDIVIDUAL DEVELOPMENT PLANS AND ADVANCE RESEARCH TRAINING AS SCHOLARS DETERMINING THAT THEY NEED DEPENDING ON THEIR RESEARCH PROJECTS. SO FOR EXAMPLE, THEY COULD OBTAIN A MASTERS OR A CERTIFICATE IN CLINICAL AND TRANSLATIONAL SCIENCE RESEARCH IF THEY WISH. AS WAS MENTIONED WITH THE T32, THIS CONCEPT WILL PROMOTE EVIDENCE INFORMED MEASURING PRACTICES. WE KNOW THAT EFFECTIVE MENTORING IS A KEY COMPONENT OF SUCCESSFUL RESEARCH CAREERS. AND SO IN THIS CONCEPT, WE EXPECT THAT PROGRAMS WILL HAVE A STRUCTURED MENTORING PROGRAM AND A DESCRIPTION OF HOW PARTICIPATING MENTORS WILL BE TRAINED AND HOW BEST TO MENTOR UTILIZING EVIDENCE INFORMED PRACTICES AND EXTENSIVE MENTORING OF RESEARCH PROGRESS AS WELL AS HOW MENTORS WILL HELP MENTEES TRACK THEIR RESEARCH CONTRIBUTIONS AND HELP LAUNCH THE CAREERS OF A DIVERSE COHORT OF CLINICAL TRANSLATIONAL SCHOLARS. ANOTHER AREA OF EMPHASIS AS WITH THE T32, WILL INCLUDE A FOCUS ON LEADERSHIP AND MANAGEMENT SKILL SETS. AGAIN, WE KNOW THAT LEADERSHIP SKILLS, PARTICULARLY FOR JUNIOR FACULTY, ARE CRUCIAL TO THEIR CAREER SUCCESS. WE EXPECT THAT PROGRAMS THAT RESPOND TO THIS CONCEPT WILL HAVE LEADERSHIP AND MANAGEMENT SEMINARS EMBEDDED IN THEIR PROGRAM SUCH THAT SCHOLARS WILL LEARN TO BECOME EFFECTIVE LEADERS SO FOR EXAMPLE, TRAINING IN EMOTIONAL INTELLIGENCE, NEGOTIATION SKILLS, COMMUNICATION SKILLS, AS WELL AS LEARNING THE ROPES OF MANAGEMENT. AS THE T32, THIS CONCEPT WILL NURTURE THE CHARACTERISTICS OF A TRANSLATIONAL SCIENTIST. WE EXPECT THAT PROGRAMS THAT RESPOND TO THIS CONCEPT WILL EXPOSE THEIR SCHOLARS TO OPPORTUNITIES TO WORK ACROSS DISCIPLINES AND FIELDS AND TO BREAKDOWN BARRIERS TO TRANSLATIONAL DISCOVERIES INTO HEALTH. AND LASTLY, WITH THIS D LINKED INSTITUTIONAL CAREER DEVELOPMENT AWARD, WE EXPECT THAT THIS WILL LEAD TO ENHANCED TRACKING OF TRANSLATIONAL SCHOLAR OUTCOMES AND MEASURES OF IMPACT, PARTICULARLY WITH REGARDS TO RESEARCH PRODUCTIVITY AND CAREER ADVANCEMENT. NEXT SLIDE. SO WHAT ARE THE IMPLEMENTATION EXPECTATIONS FROM THIS CONCEPT? WE EXPECT THAT WITH THIS CONCEPT WE WILL CONTRIBUTE TO CREATING A CLEAR AND SUSTAINABLE CAREER PATHWAY FOR JUNIOR FACULTY. THIS IS AN AREA WE HAVE GRAPPLED WITH FOR SOMETIME AND WE HOPE AND EXPECT THAT PROGRAMS WILL HELP TO CONTRIBUTE TO A MORE SUSTAINABLE CAREER PATHWAY FOR THOSE SCHOLARS WHO ARE BEING TRAINED UNDER THE CTSA PROGRAM. WE ALSO EXPECT THAT THIS CONCEPT WILL ENABLE SCHOLARS TO ACQUIRE THE KNOWLEDGE AND SKILL SETS NEEDED TO CROSS TRANSLATIONAL HURDLES. YOU HEARD A LOT ABOUT THAT TODAY. AND WE EXPECT THAT WITH THIS CONCEPT, WE WILL CONTRIBUTE TO ENHANCING AND EXPANDING THE POOL OF TRAINEES AND SCHOLARS WHO HAVE THE SKILL SETS THAT ARE NEEDED IN TRANSLATIONAL SCIENCE. AND LASTLY, THIS CONCEPT SUPPORTS THE NCATS STRATEGIC GOAL 3, WHICH IS TO DEVELOP AND FOSTER INNOVATIVE TRANSLATIONAL TRAINING AND HIGHLY SKILLED AND DIVERSE TRANSLATIONAL SCIENCE WORKFORCE. NEXT SLIDE. SO IN SUMMARY, DCI IS PROPOSING THIS CONCEPT THAT LEVERAGES THE STRENGTHS OF CTSA PROGRAM HUBS. AS YOU HEARD THROUGHOUT THE DAY TODAY, CTSA PROGRAM HUBS CREATE AN ENVIRONMENT OF EXCELLENCE AND INNOVATION THAT ACCELERATES THE TRANSALATION OF DISCOVERIES BE THEY IN THE LABORATORY, CLINIC AND/OR THE COMMUNITY INTO TANGIBLE HEALTH BENEFITS. THIS CONCEPT WILL BUILD ON THAT BUT OFFER CUSTOMIZATION OF CAREER AND TRAINING EDUCATION OPPORTUNITIES AGAIN CONSISTENT WITH LOCAL CTSA STRENGTHS AND OPPORTUNITIES. THE GOAL OF THE CONCEPT IS TO SUPPORT THE NEXT GENERATION OF DIVERSE AND CLINICAL AND TRANSLATIONAL SCIENTISTS WHO HAVE THE KNOWLEDGE, SKILL SETS AND ABILITIES TO ADVANCE DISCOVERIES ACROSS THE TRANSLATIONAL SCIENCE SPECTRUM. T0-T4, TO IMPROVE HEALTH. NEXT SLIDE. I WILL NOW TURN IT BACK OVER TO ANNA AND JONI AND THE DISCUSSANTS AND HAPPY TO TAKE QUESTIONS. >> THANK YOU VERY MUCH, JOAN. THE DISCUSSANTS FOR THIS SECTION ARE PAULA AND MARSHAL. PAULA WOULD YOU LIKE TO KICK US OFF? >> SURE. IT SEEMS AS THOUGH THE ONLY REAL DIFFERENCE FOR THIS PROGRAM IS KIND OF THE UNLINKING OF THE REVIEW AND THE DIFFERENCES IN THE FUNDING. SO I DON'T THINK THERE IS A LOT DIFFERENT, WHICH IS FINE BECAUSE OBVIOUSLY ONE OF THE HUGEST PROBLEMS WE ARE HAVING IS CLINICIANS AND SCIENTISTS NOT MAKING -- THERE IS A VALLEY OF DEATH NOT ONLY FOR INNOVATIONS AND PRODUCTS AND DRUGS, BUT THERE IS A VALLEY OF DEATH FOR CLINICIAN RESEARCHERS AND SCIENTISTS IN THE CAREER TRAJECTORY OF GETTING CAREER DEVELOPMENT AWARDS AND GETTING TO THE R OR WHATEVER OTHER FUNDING MECHANISM. SO THING IS CRITICAL. WE ARE HAVING PROBLEMS WITH HAVING CLINICIANS WHO WILL DO CLINICAL TRIALS, GIVEN THE MIGHTY CHASE FOR THE RBU AND HOW CLINICIANS ESPECIALLY ARE BEING JUDGED AND MEASURED. SO THESE ARE CRITICAL, CRITICAL PROGRAMS SO THAT WE CAN TRAIN AND WORKFORCE DEVELOPMENT AND TRAIN THE NEXT GENERATION OF SCIENTISTS AND CLINICIAN RESEARCHERS TO CARRY ON WHAT ABSOLUTELY NEEDS TO BE DONE SO THAT I CAN BE TAKEN CARE OF IN MY OLD AGE. SO I HIGHLY SUPPORT THESE PROGRAMS. >> THANK YOU. MARSHAL? >> I'M GOING ECHO PAULA. I REALLY LIKE THESE PROGRAMS. I LIKE THE UNLINKING OF THAT AND THANK YOU FOR THE CLARIFICATIONS FROM THE AUDIENCE BECAUSE EVERYONE KEEPS THROWING THESE TWO TOGETHER OVER THE YEARS AND I KEEP -- THE ONE THING THAT I THINK WE NEED TO CONSIDER IS -- AS A CLINICAL DIVISION CHIEF, WHAT I'M FINDING IS JUST FINALLY 75% PROTECTION ON A BUDGET THAT DOESN'T SUPPORT THE 75% OF A SALARY FOR THAT CLINICIAN NEEDS. THE DIVISION CHIEF IS EATING 30-40% OF THAT PERSON'S PRODUCTIVITY OR AT LEAST OF THE COVERAGE FOR THAT PERSON. AND WE USED TO BE ABLE TO DO THAT MUCH MORE EASILY THAN WE CAN DO NOW. I DON'T KNOW IF ANY OTHER CLINICIANS WOULD AGREE WITH ME ON THAT. BUT I THINK THAT IS SOMETHING WE REALLY HAVE GOT TO ADDRESS IS WHEN WE WANT A GUARANTEE OF 75% PROTECTED TIME, WE PROBABLY NEED TO FIND A WAY TO COVER CLOSE TO 75% OF THAT PROTECTION. BECAUSE THE GAP IS GETTING HARD TO FILL. >> WE DO HAVE THE OPTION FOR SURGICAL SPECIALTY TO COMMIT 50% EFFORT. SO AT LEAST WITH THE INTERVENTIONAL FOLKS, THE SURGEONS THERE IS FLEXIBILITY THERE. YOU HAD COMMENTS, MIKE? >> I WOULD LIKE TO FOLLOW-UP ON MARSHAL'S COMMENT. I'M A VASCULAR SURGEON ANDA I A K08. AND THE MARGIN FOR THE CLINICAL DEPARTMENTS HAS GOTTEN SMALLER AND SMALLER AND SO IT IS HARDER AND HARDER FOR CLINICAL DEPARTMENTS EACH AT THE 50% LEVEL BECAUSE IT IS IMPORTANT FOR SURGEONS AND INTERVENTIONALISTS TO KEEP THE CLINIC ACTIVE AND THEIR SKILLS UP FOR WHAT THEY ARE DOING. BUT THIS GAP, AND THEN I'M ALSO AN REC LEADER FOR A PEPPER CENTER. SO RESEARCH EDUCATION CORE. SO WE ALWAYS ARE HAVING TO BALANCE. WE ONLY HAVE A CERTAIN AMOUNT OF FUNDS AND WE WANT TO SUPPORT CLINICIAN INVESTIGATORS AND THEN WE HAVE PHS WHO ARE DOING WORK THAT IS ALSO VERY RELEVANT BUT WE CAN SUPPORT MORE PH.D.s AND ONLY ONE MD. SO WE ARE ALWAYS FIGHTING THIS BATTLE OF HOW DO WE SUPPORT OUR TRAINEES AND HOW DO WE EXPAND THE POOL WITH WHAT IS SAID. A LIMITED SMALLER BUDGET AND ASKING CLINICAL DEVELOPMENTS TO FRONT MORE AND MORE AND THEY ARE ACTUALLY -- NOT THAT THEY ARE UNWILLING, THEY ARE UNABLE IN THE CURRENT FISCAL ENVIRONMENTS. >> YES. I'D SAY IT REALLY IS GETTING HIT SOME FINANCIAL REALITIES. IN SOME WAYS, THE SURGICAL INTERVENTIONS HAVE A HIGHER MARGIN WHERE THEY CAN SUPPORT A TRAINEE, EVEN THOUGH THEY ARE TAKING A HUGE FINANCIAL HIT BY DOING THAT. BUT ACTUALLY A LOT OF THE MEDICAL SPECIALTIES THAT YOU WANT TO SUPPORT THROUGH THIS, ARE EITHER NEGATIVE MARGIN FOR HOSPITALS, MOST WHAT I WOULD CALL SPECIALTIES ARE NEGATIVE MARGINAL HOSPITAL. SO THERE LITERALLY IS NO ROOM IN THE BASE BUDGET TO DO THIS. SO THE HOSPITAL IS ALWAYS TAKING A LOSS ON THOSE. YOU CAN JUSTIFY A CERTAIN NUMBER BUT IT'S STARTING TO LIMIT THE POOL OF WHAT WE CAN DO. >> SO I'LL JUST -- THESE ARE REALLY GREAT COMMENTS AND ACTUALLY THE CTSA PROGRAM, CAN THE L2, RECOGNIZED THIS -- THE KL2, AND THE ONLY PROGRAM ACROSS THE NIH THAT PROVIDES BARELY SIGNIFICANT SALARY FOR THE SCHOLARS. RIGHT NOW, OUR LIMITED 120,000, WHICH IS FAR ABOVE WHAT OTHER K PROGRAMS PROVIDE TO THEIR SCHOLARS. SO IT'S DEFINITELY SOMETHING THAT WE ARE LOOKING AT AND CONCERNED ABOUT AS WELL. >> SO THESE ARE THE BIG MARIE EVANGELISTA:S OF K12. SO MOST OF THE OTHER K12S ARE 75 -100,000. >> I KNOW. I HAD SO MANY K SCHOLARS OVER THE YEARS AND THE CEO LOOKS AT ME WITH CROSSED EYES WHEN I COME TALK TO HIM. BUT REALIZE STARTING SALARIES ARE STARTING TO GET INTO THE 170, 180 RANGE, EACH FOR THE LOWEST-PAID PEDIATRICIANS AND GENETICISTS IN THE FIELD AND IT GOES UP FROM THERE. SO THAT GAP, IN OTHER WORDS WE DO APPRECIATE INCREASING, IT'S NOT GETTING US EVEN CLOSE. >> THANK YOU FOR THE COMMENTS. AND MUCH APPRECIATED, MARSHAL THAT SENTIMENT. RAJ YOU HAD YOUR HAND UP. I WANT TO MAKE SURE YOU HAVE A CHANCE TO COMMENT. >> I HAVE A GENERAL QUESTION ABOUT THESE TRAINING PROGRAMS IN THE CONTEXT OF CLINICAL. SEEMS TO BE A STRONG FOCUS ON THE CLINICAL SIDE, WONDERING ABOUT THE TRANSLATIONAL SCIENCE PIECE AND HOW -- WHAT DOES ANY ENCOURAGEMENT IN THESE PROGRAMS TO ENSURE THAT THERE IS OPPORTUNITIES FOR THE TRAINEES TO HAVE INDUSTRY EXPERIENCE? SO DO SABBATICAL ITS, EXTERNSHIPS, WORKING IN INDUSTRY LAB, HAVING INDUSTRY MENTOR? I RAN A POSTDOC PROGRAM AT NOVARTIS WHO HAD DUAL PARTNERSHIP AT MIT HARVARD AND NOVARTIS AND HAS 100 PLUS POSTDOCS IN THAT PROGRAM AND THOSE ARE PEOPLE THAT GET BONA FIDE TRANSLATIONAL TRAINING TO BE THE NEXT DRUG HUNTERS OF THE FUTURE. SO I'M JUST LOOKING FOR SOME SENSE OF ARE WE TRAINING THE NEXT PHYSICIANS AND GENERAL PRACTITIONERS HERE? ARE WE TRAINING PEOPLE WHO CAN ALSO THEN GO AHEAD AND FIND THE NEXT MEDICINES OF THE NEXT CENTURY? >> YES, SO THANK YOU FOR THAT QUESTION. REALLY I APPRECIATE IT BECAUSE THIS IS SOMETHING THAT WE HAVE BEEN WORKING ON SINCE THE INCEPTION OF THE PROGRAM. SO YOU SAW IN THE INFO GRAPHIC FROM THE DR. RUBIO DISPLAYED. THAT WE ARE REALLY TRYING TO NURTURE THE CHARACTERISTICS OF A TRANSLATIONAL SCIENTIST AND SO THE UNIQUE FEATURES OF THE CTSAK12 DISTINGUISHES IT FROM OTHER K12S ACROSS THE NIH IS THERE IS A STRONG EMPHASIS ON TEAM SCIENCE, TEAM SCIENCE TRAINING, EMPHASIS ALSO ON COMMUNICATION AND AS WELL AS DISSEMINATION AND IMPLEMENTATION. AND WE HAVE WORKING GROUPS UNDER THE WORKFORCE DEVELOPMENT ENTERPRISE COMMITTEE THAT ARE HELPING OUR SCHOLARS OBTAIN THESE TRANSLATIONAL SKILL SETS SO THAT THEY CAN REALLY HAVE TANGIBLE -- A TANGIBLE IMPACT ON HEALTH OUTCOMES. IN ADDITION IN 2016, WE LAUNCHED A PROGRAM WITH ELI LILLY THAT ALLOWS TRAINEES, TL1, T32s AND K12s TO GO TO INDUSTRY AND HAVE AN EXPERIENCE WHERE THEY LEARN FROM INDUSTRY SCIENCE IN TERMS OF SCIENTISTS IN TERMS OF CLINICAL TRIAL DESIGNS, PK/PD STUDIES AND THIS PROGRAM HAS BEEN IN PLACE FOR OVER THREE YEARS. I CONTRIBUTED TO THE LAUNCH OF THAT PROGRAM IN 2016 AND WE HAD AT LEAST TWO SCHOLARS OR TRAINEES GOING THROUGH THAT PROGRAM IN THREE YEARS. LAST YEAR BECAUSE OF COVID, THAT PROGRAM WAS PUT ON HOLD. BUT WE ONLY HEARD DR.SHIRERA MAY BE ABLE TO COMMENT ON THIS, WE HAD AMBASSADOR FOR THAT PROGRAM FROM SAN ANTONIO, AN ONCOLOGIST AND SHE WENT TO ELI LILLY, WORKED THERE AS A KL2 SCHOLAR AND BROUGHT BACK THOSE SKILL SETS TO THE ACADEMIC INSTITUTION AND SHE STILL CONTINUING TO HAVE COLLABORATIONS WITH ELI LILLY SCIENTISTS. SO WE ARE STARTING TO LOOK AT WAYS TO EXPAND THOSE OPPORTUNITIES, EDUCATIONAL OPPORTUNITIES IN INDUSTRY AND NON-PROFITS AND OTHER SECTORS FOR OUR TRAINEES. SOMETIMES IT'S A LITTLE DIFFICULT BECAUSE OF THE AGREEMENTS YOU NEED IN ORDER TO DO THOSE -- TO PROVIDE THOSE OPPORTUNITIES SO AS YOU KNOW, YOU NEED NON DISCLOSURE AGREEMENTS AND THE RESEARCH THAT IS BEING CONDUCTED HAS TO BE CLEARLY DEFINED AND SO ON. >> THANK YOU. [ MULTIPLE SPEAKERS ] >> ALL I WOULD SAY IS, I UNDERSTAND ALL OF THAT BUT IT'S IMMINENTLY DOABLE. IT'S NOT, NOT DOABLE. HAVING DONE IT, I CAN TELL YOU IT IS WORTH THE SQUEEZE. >> THANK YOU. >> WE AGREE. AND WE ARE EXPLORING MORE WAYS TO MAKE THAT MORE AMENABLE TO INSTITUTIONS. >> THANK YOU FOR THAT. OKAY, SO WE NEED TO GO AHEAD AND MOVE FORWARD. I THINK THERE WAS ONE MORE COMMENT FROM BECKY JACKSON, MAKING SURE THAT THERE IS DEVELOPMENT AND RESOURCES AND TOOLKITS THAT CAN BE SHARED AND ADOPTED BY OTHER HUBS AS WELL. THIS SHOULD BE BUILT INTO K12 AS WELL. SO I WANTED TO MAKE SURE THAT COMMENT WAS HEARD. WE ARE GOING TO MOVE ON TO THE NEXT CONCEPT -- I'M SORRY? WE'RE GOING TO MOVE TO THE NEXT CONCEPT. DR. JAMIE DOYLE FOR THE RESEARCH EDUCATION AWARDS. JAMIE, GO AHEAD, PLEASE. >> WELCOME, EVERYONE TO THE LAST CONCEPT OF THE DAY. MY NAME IS JAMIE DOYLE AND I'M A PROGRAM OFFICER IN THE DIVISION OF CLINICAL INNOVATION AND I WILL BE PRESENTING A NEW CONCEPT CLEARANCE FOR THE RESEARCH EDUCATION PROGRAM, R25. THE RESEARCH EDUCATION PROGRAM R25 IS AMONG THE SUITE OF CAREER TRAINING AND RESEARCH EDUCATION CONCEPTS FOR THE CTSA PROGRAM. FOR THOSE WHO MAY NOT BE FAMILIAR WITH THE RESEARCH EDUCATION PROGRAM, THE NIH RESEARCH GRANT SUPPORTS ACTIVITIES IN FOUR BROAD AREAS. RESEARCH OPPORTUNITIES THAT COMPLIMENT AND/OR ENHANCE THE TRAINING OF THE BIOMEDICAL WORKFORCE BUT IN WAY THAT IS DO NOT DUPLICATE EFFORTS. THAT IS EFFORTS TAKING PLACE IN TRAINING GRANTS. THE R25 CAN ALSO BE USED TO ENHANCE DIVERSITY. SOME NIH INSTITUTES USE THE R25 TO HELP RECRUIT INDIVIDUALS WITH SPECIFIC SPECIALTIES OR DISCIPLINARY BACKGROUNDS WHILE OTHER INSTITUTES USE THE RESEARCH EDUCATION GRANTS TO FOSTER A BETTER UNDERSTANDING OF BIOMEDICAL, BEHAVIORAL AND CLINICAL RESEARCH AND IMPLICATIONS. THERE ARE CURRENTLY 25 ACTIVE R25 FUNDING OPPORTUNITIES ACROSS NIH. AS MERCEDES MENTIONED, THE TL1 SUPPORTS SHORT TERM POSITIONS WHICH INCLUDES PRE-DOCTORAL AND POSTDOCTORAL OPPORTUNITIES. SHORT TERM POSITIONS ARE USED TO SUPPORT SOME RESEARCH OPPORTUNITIES FOR UNDERGRADUATES, THOSE IN THE FIRST OR SECOND YEAR OF A HEALTH PROFESSIONAL DEGREE AND GRADUATE STUDENTS. THESE SHORT TERM POSITIONS ARE ALSO USED TO PROVIDE RESEARCH OPPORTUNITIES WITH A FOCUS ON ENHANCING DIVERSITY. THIS OFFERS THE OPPORTUNITY FOR HUBS TO EXPAND AND ENHANCE WORKFORCE DEVELOPMENT EFFORTS IN THIS SPACE. WE EXPECT THAT THE R25 CONCEPT WILL AS ALREADY MENTIONED, COMPLIMENT AND/OR ENHANCE WORKFORCE DEVELOPMENT EFFORTS. IT WILL PROVIDE SHORT TERM RESEARCH EXPERIENCES THAT ARE BETWEEN 10-15 WEEKS. THESE ARE RESEARCH EXPERIENCES NOT AVAILABLE THROUGH FORMAL NIH TRAINING MECHANISMS AND IT WILL HELP BUILD A PATHWAY FOR TRANSLATIONAL SCIENCE WORKFORCE OF THE FUTURE. FOR EXAMPLE, WE EXPECT THAT THE RESEARCH EDUCATION PROGRAM CONCEPT WOULD MAKE IT POSSIBLE FOR JUNIOR FACULTY MEMBERS FOR MINORITY SERVING INSTITUTIONS SUCH AS HISTORICALLY PLAQUE COLLEGES AND UNIVERSITIES, HISPANIC-SERVING INSTITUTIONS, TRIBAL COLLEGES AND UNIVERSITIES, TO COLLABORATE AND PARTICIPATE IN SHORT TERM RESEARCH EXPERIENCES THAT HAVE PARTNER INSTITUTIONS. THAT IS SOMETHING THAT IS NOT CURRENTLY LEVERAGED. SIMILARLY, IT CAN SERVA AS A WAY TO EXPOSE UNDERGRADUATES TO THE SCIENTIFIC AND OPERATIONAL PRINCIPLES UNDERLYING EACH STEP OF THE TRANSLATIONAL PROCESS. IN TERMS OF IMPLEMENTATION AND IMPACT, THE R25 ENHANCES THE CAREER AND TRAINING EDUCATION OPPORTUNITIES AVAILABLE TO THE CLINICAL AND TRANSLATIONAL SCIENCE WORKFORCE. SIMILAR TO THE OTHER TRAINING CONSENTS, THIS INITIATIVE ALSO SUPPORTS NCATS STRATEGIC GOAL 3, TO DEVELOP AND FOSTER INNOVATIVE TRANSLATIONAL TRAINING ON A HIGHLY-SKILLED, CREATIVE AND DIVERSE TRANSLATIONAL SCIENCE WORKFORCE. TO SUMMARIZE THIS CONCEPT, THE RESEARCH EDUCATION PROGRAM WILL PROVIDE SHORT TERM CLINICAL AND TRANSLATIONAL RESEARCH OPPORTUNITIES THAT ARE BETWEEN 10-15 WEEKS THAT ARE NOT AVAILABLE THROUGH OTHER TRAINING MECHANISMS. THIS PROGRAM WILL ALLOW HUBS TO CUSTOMIZE CAREER AND TRAINING EDUCATION OPPORTUNITIES THAT COMPLIMENT AND/OR ENHANCE LOCAL STRENGTHS. SOME EXAMPLES INCLUDE SUMMER RESEARCH EXPERIENCES FOR UNDERGRADUATES AND JUNIOR FACULTY PROGRAMS FOR RESEARCHERS FROM MINORITY-SERVING INSTITUTIONS. MOST IMPORTANTLY, THE RESEARCH EDUCATION PROGRAM AS PART OF THE NEW SUITE OF CTSA PROGRAM CONCEPTS WILL HELP TO ENSURE THE DEVELOPMENT OF A DIVERSE 21ST CENTURY WORKFORCE CAPABLE OF ADVANCING CLINICAL AND TRANSLATIONAL SCIENCE. WITH THAT, I'D LIKE TO TURN OVER TO COUNCIL MEMBERS FOR COMMENTS AND FEEDBACK ON HOW TO IMPROVE THIS INITIATIVE. >> THANK YOU JAMIE. FOR THIS, WE HAVE CRESLER AND SUMMER AS THE DISCUSSANTS. SO WE WILL GO TO -- WHO WOULD LIKE TO GO FIRST? >> I CAN START. >> THANK YOU. >> THIS IS CLEARLY THIS NEEDS TO BE CONTINUED AND TO BE EXPANDED BASED ON EXPERIENCES. IT'S A CRITICAL TOOL FOR PARTICULARLY MINORITIES. AND IF YOU HAVE AN OPPORTUNITY TO LEVERAGE INTO THE UNDERGRADUATE, [ INAUDIBLE ] ONE ASPECT WHICH I HOPE YOU ARE ALREADY DOING AND HELPFUL -- LEARNING SHARING BETWEEN THE SIDES AND HOW TO REACH MINORITIES AND BRING THEM ONBOARD AND ENGAGE THEM AND HAVING -- ACCESSIBLE AND DEVELOPING TEACHING TRAINING TOOLS FOR SCIENTISTS, THIS GENERATION OF SCIENTISTS -- >> I WHOLEHEARTEDLY AGREE. I THINK THE HUB SHOULD BE A EXCHANGING BEST PRACTICES ESPECIALLY ON HOW TO RECRUIT, MAINTAIN AND MENTOR MINORITY STUDENTS. I THINK THAT IS CRITICALLY IMPORTANT AND ALSO JUST IN GENERAL, EXCHANGING BEST PRACTICES AND PEDAGOGICAL. I THINK IT WOULD BE TREMENDOUS FOR THIS PROGRAM. >> OKAY. THANK YOU FOR YOUR COMMENTS. MARSHAL YOU'RE THE OTHER DISCUSSANT. DO YOU HAVE ANYTHING TO ADD? >> NOT A WHOLE LOT TO ADD AND I KNOW IT'S LATE IN THE DAY SO I WON'T SAY MUCH. I THINK EARLIER IS BETTER, JAMIE, WHICH IS WHERE YOU'RE GOING. WE WERE ABLE TOL MOVE OUR PEDIATRIC RESIDENCY PROGRAM FROM 15% MINORITY REPRESENTATION TO 45% BY FOCUSING EARLIER IN THE PIPELINE. AND FINDING THOSE FOLKS AND PARTICULARLY IN THE HIGH SCHOOL, THESE TYPES OF THINGS, PRIZES AND AWARDS AND I THINK FRANKLY MAKING SURE THAT THEY GET HIGHLY PUBLICIZED TOO, LIKE THE OLD WESTING HOUSE AWARDS. THOSE THINGS ARE HIGHLY IMPACTFUL. IT GIVES PEOPLE FOR SOMETHING TO SHOOT AFTER. ABSOLUTELY SUPPORT IT. >> THANK YOU. THANK YOU FOR YOUR COMMENTS. AND I SEE RAJ HAS A COMMENT. >> SO THIS IS WHERE YOU HAVE LOW-HANGING FRUIT AGAIN TO ENGAGE INDUSTRY. THIS IS A SUMMER PROGRAM OR WHAT NOT. YOU COULD ALSO THINK ABOUT MATCHING FUNDS IF YOU WILL. WHERE YOUR FUNDING 6, THEY ARE FUNDING 6. YOU CAN CREATE ALL SORTS OF ECONOMIES OF SCALE HERE THAT COULD LEVERAGE AND I THINK THEY WOULD BE WELCOME PARTNERS GIVEN, DEPENDING ON WHERE THE CTSAs ARE AND WHERE LOCAL COMPANIES HAVE RESEARCH SITES. I HAD ONE -- [ MULTIPLE SPEAKERS ] >> HOW INSTITUTION VISIT SET UP THESE AGREEMENTS SO NOT HAVE TO REINVENT THE WHEEL -- THAT'S A OPPORTUNITY AS SUCH MENTIONED HAVING A SET OF GOOD PRACTICES -- >> AND I JUST ASK ONE OPERATIONAL QUESTION, MAYBE I MISSED THIS. SO I UNDERSTAND NOW THAT YOU'RE UNLINKING THE MECHANISM FOR THE HUB WITH ALL OF THESE PROGRAMS AND YOU'RE GOING TO REVIEW THEM SEPARATELY BUT THESE AWARDS ARE CONTINGENT UPON THERE BEING A HUB AWARD IF I UNDERSTAND THAT CORRECTLY. ARE YOU FROM A RFP AND A REVIEW PROCESS GOING TO DO THE UM1s FIRST AND THEN THEY GET TO APPLY TO THESE? OTHERWISE DOING THEM IN PARALLEL MIGHT BE A WASTE OF EFFORT ON THE REVIEW SIDE BECAUSE IF YOU DON'T GET THE UM1s, YOU CAN'T LINK THEM TO A EXISTING AWARD UM1. >> YES. MIKE OR -- >> THE COMPETITION WILL BE LIMITED TO THE UM1 BUT WE ARE ALLOWING PEOPLE TO COME IN AT THE SAME TIME. NOW YOU'RE CORRECT IF THEY DON'T GET THE UM1, THEN HOW THEY DO THE REVIEW, BUT ONCE THEY HAVE A SUCCESSFUL UM1, THEY JUST COME BACK IN WITH -- >> ONCE THEY HAVE A SUCCESSFUL UM1, I UNDERSTAND BUT APPLYING IN PARALLEL IS WHERE I'M HAVING A LITTLE BIT OF DISSONANCE BECAUSE THAT DOESN'T MAKE SENSE TO ME BECAUSE LET'S SAY I DON'T KNOW WHAT YOU'RE CUT OFF IS, LET'S SAY ONLY 20% OF YOUR APPLICANTS ARE U -- >> SO TO GIVE YOU JUST AN EXAMPLE, I THINK WITH A CURRENT -- I THINK ABOUT 70% OF OUR HUBS HAVE T PROGRAMS. AND WE ANTICIPATE THAT IN KEEPING ALL OF THE FUNDING LEVELS ABOUT THE SAME, THEN WE WOULD ANTICIPATE THAT WE WILL BE ABLE TO AFFORD DOWN THE PAY LINE EVERYONE WHO WANTS A T PROGRAM AT THIS POINT. THE SAME WITH THE Ks. I MEAN, TYPICALLY THE Ks AND THE Ts ARE WELL ALIGNED. SO I THINK THE SITUATION YOU'RE TALKING ABOUT IS GOING TO BE A VERY UNUSUAL SITUATION AND IS GOING TO EFFECT PERHAPS AT MOST MAYBE ONE APPLICATION A YEAR AT MOST. >> OKAY. THANK YOU SO MUCH. I THINK THAT CONCLUDES OUR PRESENTATIONS FOR THE DAY. AND SINCE WE ARE STILL SORT OF IN THE DISCUSSION SECTION, I WANT TO GO BACK TO THE FEATURES OF THIS AND SORT OF BRING BACK THIS LETTER THAT WE RECEIVED FROM A SUBSET OF THE CTSA PROGRAM INSTITUTIONS REQUESTING IMMEDIATE DELAY OF THE U54FOA. AND BECAUSE THIS LETTER WAS RELATED TO THE CONCEPTS THAT ARE BEING CONSIDERED, WE WANTED TO JUST PROVIDE AN OPPORTUNITY FOR THE COUNCIL TO DISCUSS THE LETTER BEFORE WE VOTE ON THEM, WHICH IS OUR NEXT STEP. AND SO SINCE THIS LETTER WAS RECEIVED PRIOR TO ANY PUBLIC DISCUSSION OF THE CONCEPTS AND HAVING THE BENEFIT OF HEARING THE DISCUSSIONS OF THE DAY, I WANTED TO JUST ASK, IF THERE IS ANYTHING IN THE LETTER THAT WAS NOT ADDRESSED BY THE CONCEPT PRESENTATIONS THAT WARRANTS WELL FURTHER DISCUSSION THAT THE COUNCIL WOULD LIKE TO BRING UP AT THIS POINT? SO I WILL ASK IF THERE ARE ANY FURTHER DISCUSSIONS THAT YOU WOULD LIKE TO BRING UP? >> RAJ? >> I HAVE TO SAY THE LETTER WAS FAIRLY SHORT AND CRYPTIC AND I DIDN'T NECESSARILY UNDERSTAND THE PARTICULAR CONCERN THAT WAS BEING RAISED BY THE SENATE BILL SET OF CTSAs AND THE CONTEXT OF WHAT I LEARNED TODAY. MAYBE SOMEBODY CAN TELL ME WHAT THEIR OBJECTION IS? >> AGREED. I COULDN'T QUITE FIGURE IT OUT. >> SO IF IT'S - IF THE LETTER WERE CLEAR IN TERMS OF WHAT THEY BELIEVE OR WHAT THEY THOUGHT THE PROBLEMS WERE GOING TO BE, THAT THEY WISH TO DISCUSS, THEN WE COULD THEN CONSIDER AS A BODY TO SAY WE RECOMMEND THAT NCATS HAVE ANOTHER PERIOD OF COMMENT OR DISCUSSIONS OR WHAT NOT BEFORE YOU MOVE FORWARD AS A CONCEPT. BUT IT JUST FEELS LIKE -- I MEAN, AGAIN I GUESS I WOULD SAY THEY HEARD THE CONCEPT IS CHANGING AND THEY WANT TO PAUSE IT BECAUSE PERHAPS THEY ARE HAPPY WITH WHAT THEY HAVE. BUT YOU HAVE GOT -- YOU HAVE GONE THROUGH, AS I UNDERSTAND, AN EXTENSIVE PERIOD OF GETTING INPUT, HAVING CONVERSATIONS TO GET TO THE POINT OF THIS CONCEPT. SO THE QUESTION IS, WHAT IS THE CONCRETE OBJECTION? >> ANY OTHER COMMENTS FROM THE COUNCIL ON THAT PARTICULAR ISSUE? >> I WOULD SAY THEY BROUGHT UP COVID AS A REASON BUT I DIDN'T NOTICE THAT THE NUMBER OF CONTACTS AND CONFERENCES AND CROSSTALK DECREASE SIGNIFICANTLY LAST YEAR IF ANYTHING I THINK IT INCREASED A LOT. AND I JUST HAD A LITTLE TROUBLE GETTING AT WHAT THEY WERE AND I THINK IF IT IS JUST WE WANT THE STATUS QUO, I'M NOT SURE THAT THAT HOLDS MUCH WITH ME. >> THANK YOU, MARSHAL. ANY OTHER COMMENTS? BECKY? >> YES, SORRY. I COULDN'T FIND MY RAISE MY HAND BUTTON. >> YOU RAISED YOUR HAND SO I GOT THAT. >> I RAISED IT BUT I WASN'T SURE IF YOU COULD STEVE IT. I THINK THAT ONE OF THE THINGS THAT DID COME UP WITH MANY OF THE PIs THAT WERE ENGAGED IN THIS IS, I THINK REALLY A LACK OF OPPORTUNITY TO HAVE A DISCUSSION FOLLOWING THE NIMBLENESS AND WHAT HAS BEEN LEARNED AS A RESULT OF THE COVID PANDEMIC, HOW THE CTSA CONSORTIUMS AND ARE THERE OTHER WAYS TO CONTRIBUTE TO THINKING ABOUT THE CONSORTIUM AS TO HOW WE CAN EVEN FUNCTION MORE EFFECTIVELY AND EFFICIENTLY AND MORE TRANSFORMATIVELY IN THE FUTURE. AND CERTAINLY, SOME OF THE IDEAS ARE NEW AND WOULDN'T NECESSARILY HAVE BEEN PRESENTED TO US BEFORE. IT COMES HERE IN FRONT OF COUNCIL BUT I THINK IT WAS THAT THE CONVERSATIONS AND THE WORLD OF TRANSLATIONAL SCIENCE IS REALLY FUNDAMENTALLY CHANGED WITH THE PANDEMIC. AND I THINK HAVING THAT KIND OF CONVERSATION, OPENING SOME DISCOURSE OF HOW DO WE TAKE ACCOUNT OF THOSE TYPES OF CHANGES IN MAKING SURE THE CONSORTIUM CAN BE BEST POSITIONED IN ORDER TO BE ABLE TO MEET THE GOALS OF NCATS? >> THANK YOU, BECKY. AND CERTAINLY WE HAVE BEEN AT THE FRONT AND CENTER ALL ALONG OF COVID AND HAVE BEEN WATCHING THAT AS WELL. AND MIKE YOU COULD PROBABLY RESPOND BETTER THAN I BUT THIS IS WHAT WE DO. SCIENCE CHANGES VERY FREQUENTLY AND OUR GOAL IS TO MAKE THE PROGRAM AS FLEXIBLE AS POSSIBLE TO BE ABLE TO REACT TO THEM. MIKE, DO YOU HAVE ANYTHING MORE TO ADD? AND THEN WE'LL HAVE ONE MORE COMMENT FROM PAULA AND THEN WE CAN MOVE ON TO THE VOTES. >> WHY DON'T WE TAKE PAULA'S COMMENT FIRST. >> GO AHEAD, PAULA. >> I WOULD ECHO BECKY. I THINK IT'S NOT HARD TO SAY THAT OUR WORLD AND WORLD VIEW HAS SHIFTED BECAUSE OF THE PANDEMIC. AND THE CTSA, I KNOW AT LEAST IN SAN ANTONIO AND ACROSS THE COUNTRY REALLY GRABBED INTO GEAR AND SHOWED US WE DIDN'T WRITE ABOUT THIS IN OUR GRANT, RIGHT? IT SHOWED US HOW IMPACTFUL WE COULD BE IN AN EMERGENCY AND IN OTHER THINGS. AND SO, I DO THINK THAT THAT WAS A LOT OF WHAT WAS PUTTING FORTH THIS LETTER. I ALSO THINK THAT GIVEN HOW INVESTED AND HOW IMPORTANT THE CTSAs WERE ACROSS THE COUNTRY WITH THE PANDEMIC, THAT THERE IS ALWAYS FEAR. FEAR OF CHANGE. AND I DO THINK PROBABLY ONE OF THE STICKING POINTS IS THAT THE CLINICAL FUNDING PIECE THAT IS IN, HOWEVER, I DO THINK IT WAS MOTIVATED WITH GOOD INTENT AND I CAN UNDERSTAND IF YOU AREN'T IN THE CTSA WORLD THE PEOPLE READING IT WOULD SEEM CRYPTIC. >> THANK YOU, PAULA. MIKE DO YOU WANT TO COMMENT ON THOSE? >> THE ONE THING I WOULD SAY IS THAT OBVIOUSLY WE HAVE BEEN WORKING ON THIS FOR SEVERAL YEARS. WE HAVE BEEN LISTENING TO THE COMMUNITY OBVIOUSLY FOR SEVERAL YEARS. AND AS WE TRIED TO OUTLINE ONE OF THE THINGS WE WERE REALLY TRYING TO DO WAS TO INCREASE THE FLEXIBILITY THAT THE HUBS HAVE. SO CAN WE TAKE A STEP BACK? CAN WE TAKE ANOTHER YEAR TO REVIEW HOW THINGS MIGHT BE DIFFERENT WITH COVID? THAT'S A THEORETICAL POSSIBILITY. I'M NOT SURE THAT WE WILL COME UP WITH ANYTHING DIFFERENT NECESSARILY THAT DIFFERENT FROM WHAT WE HAVE ALREADY. AND I WOULD WOULD BE HESITANT TO BE MORE PRESCRIPTIVE THAN WHAT WE HAVE BEEN IN THE PAST. I THINK ONE OF THE THINGS WE ARE TRYING TO MOVE AWAY FROM BEING OVERLY PRESCRIPTIVE AND GIVE THE HUBS MORE FLEXIBILITY TO LET THEM ALLOCATE THEIR RESOURCINGS AND THEIR CAPABILITIES IN A MUCH MORE FACILE MANNER WITH A SIMPLIFIED BUDGET. SO I THINK WHAT WE HAVE DONE WHILE MAYBE ONE COULD SEE IT DOESN'T DIRECTLY ADDRESS COVID, I THINK WHAT WE HAVE DONE WILL BE AMENABLE TO ANY CHANGES OR EVOLUTIONS THAT INSTITUTIONS FEEL WILL COME AS A RESULT OF COVID GOING FORWARD. >> THANK YOU, MIKE. AND RAJ YOU HAVE A FOLLOW-UP COMMENT? >> MIKE JUST SORT OF TOOK THE WORDS OUT OF MY MOUTH. THE BOTTOM LINE IS I WILL JUST ECHO. AND I DIDN'T HEAR ANYTHING THIS AFTERNOON THAT SUGGESTS TO ME THAT WHATEVER PIVOTS THE CTSAs MIGHT HAVE DONE, AND I APPRECIATE PAULA'S COMMENT I'M NOT IN THE CTSA SO I DON'T KNOW WHAT THEY MIGHT HAVE DONE, BUT I DIDN'T SEE ANY LOSS OF DEGREES OF FREEDOM THAT WOULD PREVENT THEM FROM CONTINUING TO DO WHAT THEY MIGHT WISH TO DO IN THIS NEW CONCEPT, IF ANYTHING, IT SIMPLIFIES THE PROCESS, AND ADDS MECHANISMS FOR TRAINEES. SO I THINK IT'S WORTH MOVING FORWARD FROM THAT PERSPECTIVE. >> THANK YOU. AND I'LL NOTE TOO THAT KEITH, SAID HE AGREED WITH THE COMMENTS THAT THERE WAS NOT SOMETHING SPECIFIC IN THE LETTER. SO SORT OF ALONG WITH THAT SENTIMENT. IN THAT CASE, AND I THINK WE HAVE EXHAUSTED THE CHAT BOX. I WILL TURN IT OVER TO YOU TO DOT OFFICIAL VOTING CRITERIA NOW. WE ARE ON THE HOMESTRETCH. THANK YOU FOR HANGING IN THERE WITH US. THIS HAS BEEN A FANTASTIC DISCUSSION. OF COURSE ALL OF THESE COMMENTS AND ANNA WILL SAY THIS TOO, ALL THESE COMMENTS ABOUT WILL GO INTO OUR PUBLIC RECORD AND WE WILL BE EVALUATING THEM AND ALSO MAKING SURE THAT WE PUT THE FINISHING TOUCHES, INCORPORATING THESE INTO THE FINAL PRODUCTS AS WE GO FORWARD. SO STAY TUNED ON THAT. ANNA, OVER TO YOU. >> ALL RIGHT. THANK YOU, JONI. INDEED, WE ARE IN THE HOMESTRETCH. SO WHAT I'M GOING TO DO NOW IS TAKE THE VOTES ON THESE INDIVIDUAL CONCEPTS IN REVERSE ORDER. SO WE ARE GOING TO START WITH THE R25 AND WORK OUR WAY UP. SO FOR THE R25, THE RESEARCH EDUCATION GRANT, DO I HAVE A MOTION TO APPROVE THE CONCEPT? >> SO MOVED. >> SECOND? >> SECOND. >> ALL IN FAVOR. >> AYE. >> ANY OPPOSED? ANY ABSTENTIONS? ALL RIGHT, WITH THAT THE R25 CONCEPT IS APPROVED. NEXT WE'LL DO THE K12, INSTITUTIONAL CAREER DEVELOPMENT AWARD CONCEPT. DO I HAVE A MOTION TO APPROVE THE CONCEPT? >> SO MOVED. >> SECOND? >> SECOND. >> ALL IN FAVOR? >> AYE. >> ANY OPPOSED? ANY ABSTENTIONS? WITH THAT, THE K12 CONCEPT IS APPROVED. THIRD COP SEPTEMBER, THIS IS OUR T32 PRE AND POST DOCK NRSA PROGRAM. DO I HAVE A MOTION TO APPROVE THE CONCEPT? >> SO MOVED. >> SECOND. >> ALL IN FAVOR. >> AYE. >> ANY OPPOSED? ANY ABSTENTIONS? WITH THAT, THE T32 CONCEPT IS APPROVED. NEXT IS OUR RC2SIP PROGRAM. MAY I HAVE A MOTION TO APPROVE THE SIP CONCEPT? >> SO MOVED. >> SECOND. >> ALL IN FAVOR. >> AYE. >> ANY OPPOSED? ANY ABSTENTIONS? WITH THAT THE RC2 CONCEPT IS APPROVED. NOW WE'LL MOVE TO OUR LAST CONCEPT OF THE DAY. THIS IS OUR CTSA SCIENCE AWARD. THIS IS OUR UM1. DO I HAVE A MOTION TO APPROVE THE CONCEPT AS PRESENTED? >> I'M SORRY? >> SO MOVED. >> SECOND? >> SECOND. >> ALL IN FAVOR. >> AYE. >> ANY OPPOSED? ANY ABSTENTIONS? AND WITH THAT, OUR UM1 CONCEPT IS APPROVED AND THEREBY THE ENTIRE SUITE OF CTSA CONCEPTS IS APPROVED. THANK YOU VERY MUCH. NOW WE WILL MAKE SURE THAT THE CHAT COMMENTS ARE INCLUDED IN THE MINUTES AND ANY COMMENTS THAT HAVE COME IN FROM THE PUBLIC TO THE INPUT MAILBOX WILL BE DOUBLED IN THE MINUTES AND BECOME PART OF THE OFFICIAL MEETING. BACK TO YOU JONI? >> THANK YOU SO MUCH FOR HANGING IN WITH US TODAY. I APPRECIATE ALL THE DISCUSSION AND I LOOK FORWARD TO SEEING YOU AGAIN IN SEPTEMBER. AND WITH THAT, I WILL GAVEL US OUT AND WE'LL SEE YOU SOON. THANK YOU, EVERYONE.