WELCOME TO THE 29TH MEETING OF THE NCATS ADVISORY COUNCIL AND I AM GOING TO SWITCH MY WEB CAM FROM THE GAVEL TO ME SO HOPEFULLY YOU CAN SEE ME NOW. EARLIER THIS MORNING WE WERE HAVING POSSIBILITIES OF SNOW ICE, THAT SEEMS TO HAVE GONE AWAY SO I THINK WE WILL BE IN GOOD SHAPE GOING FORWARD. THE MEETING TO SPAN A COUPLE OF DAYS TODAY AND TOMORROW AND WE HAVE A PACKED AGENDA, HOPE YOU WILL FIND IT INTERESTING. BEFORE WE START, ANNA I WILL TURN IT TO YOU FOR THE OFFICIAL ROLL CALL. >> NEXT SLIDE PLEASE. PAUL HARRIS. >> HERE. >> KRISTINA HARTMAN. KRISTINA, ARE YOU THERE? TED HOLEMAN. >> GOOD MORNING. REBECCA JACKSON. >> HERE >> ANNIE KENNEDY. >> HERE. >> MATTHIAS KRRETZLER. >>ER HUE. >> KELLY MCVEARRY. >>ER HUE. >> KEITH MUELLER >> HERE. >> RAJESH RANGANATHAN >> HERE. PAULA SHIREMAN. >> HERE. >> AND MARSHALL SUMMAR. THOSE ARE OUR COUNCIL MEMBERS. JONI, BACK TO YOU. >> THANK YOU SO MUCH. THIS IS THE AGENDA FOR TODAY'S PORTION OF THE NCATS COUNCIL AND WE HAVE A VARIETY AND PROGRAMMATIC UPDATES AND CONCEPT CLEARANCES TO I LOOK FORWARD TO GOING THROUGH THOSE EVENTS WITH YOU. I THINK THEN WE'LL ADJOURN FOR DAY ONE AND COME BACK TOMORROW AT 1 P.M. EASTERN TIME AGAIN. AND WE'LL HAVE A VARIETY OF PRESENTATIONS FOR TOMORROW AS WELL. BEFORE WE START WITH DIRECTOR'S REPORT I'LL TURN IT TO ANNA FOR ANNOUNCEMENTS TO MAKE SURE WE ARE ON THE SAME PAGE FOR VARIETY OF KEY THINGS YOU NEED TO KNOW ABOUT BEFORE WE START THE DAY. ANNA BACK TO YOU. >> THANK YOU, JONI. EVERYONE IN ZOOM MEETING IS A PANELIST TODAY SO YOU ARE FREE TO SPEAK. HOWEVER IN ORDER TO MAINTAIN A SMOOTH FLOW WE REQUEST YOU USE THE RAISED HAND FEATURE AND WAIT UNTIL CALLED UPON TO PROVIDE INPUT. WE ASK YOU RESERVE USE OF THE CHAT FOR ACTIVITIES SUCH AS POSTING LINKS PERHAPS, INFORMATION, BUT PLEASE USE THE CHAT TO A MINIMUM. PLEASE ALLOW SPEAKERS TO MOVE THROUGH THEIR PRESENTATIONS, NOTING YOUR COMMENTS AND THEN PRESENTING THEM WHEN CALLED UPON. WE ARE USING THE VIDEOCAST FEATURE TODAY, SO FOR THOSE OF YOU WHO ARE NOT IN THE ZOOM MEETING, YOU MAY SUBMIT COMMENTS BY USING THE EMAIL FUNCTION AVAILABLE ON THE NIH VIDEOCAST SITE. THERE IS A BUTTON THERE AND OR YOU CAN SEND EMAIL DIRECTLY TO THE ADDRESS LISTED IN THE SLIDE NCATS COUNCILINPUT@MAIL.NIH.GOV. SO THE FIRST THING I WOULD LIKE TO DO IS CONSIDERATION OF OUR MINUTES AND OUR NCATS GENERAL COUNCIL OPERATING PROCEDURES. WE ARE SEEKING APPROVAL OF THE MINUTES FOR THE SEPTEMBER 21ST MEETING, THEY ARE AVAILABLE IN THE ELECTRONIC COUNCIL BOOK. COULD WE HAVE A MOTION TO APPROVE THE MINUTES FOR THE SEPTEMBER 21ST MEETING? >> SO MOVE. >> THANK YOU. SECOND? >> SECOND. >> ALL IN FAVOR? >> A. AYE. AYE. >> ANY OPPOSED? ANY ABSTENTIONS? THE MINUTES ARE APPROVED. I WOULD ALSO NOW LIKE TO MOVE TO SEEKING YOUR APPROVAL FOR COUNCIL OPERATING PROCEDURES FOR 2022. THESE ARE ALSO AVAILABLE IN YOUR ELECTRONIC COUNCIL BOOK. COULD WE HAVE A MOTION TO APPROVE THE 2022 COUNCIL OPERATING PROCEDURES? >> SO MOVED. >> HE COULD IS. >>> SECOND. >> ALL IN FAVOR. >> A. >> ANY OPPOSED? ANY ABSTENTION? WITH THAT OUR OPERATING PROCEDURES FOR 2022 ARE APPROVED APPROVED. NEXT SLIDE PLEASE. FUTURE DATES FOR OUR ADVISORY COUNCIL MEETING IN 2022 WE PLAN TO MEET MAY 19 AND SEPTEMBER 22ND FACE TO FACE AS OF NOW. IN 2023 WE INTEND TO HAVE A VIRTUAL MEETING ON JANUARY 26 AND 27 AS WE ARE TODAY. AND TOMORROW AND HAVE FACE TO FACE MEETINGS ON MAY 25 AND SEPTEMBER 28TH. I WOULD LIKE TO POINT OUT TINA MORRISON FROM THE FDA ALSO JOINED US TODAY ON BEHALF OF FRANK WHITEHOLD. WITH THAT, I WOULD LIKE TO TURN IT BACK OVER THE JONI. -- OVER TO JONI. >> THANK YOU VERY MUCH. I WILL GET START WITH THE COUNCIL REPORT AND I HAVE TO SAY A LOT HAPPENED SINCE WE LAST MET, SEEMS FOUR MONTHS IS A LONG TIME. AND NOT LEAST OF WHICH OF COURSE IS THAT DELTA HAS COME ON SCENE, OFF SCENE AND NOW OMICRON IS NOW THE WE WE ARE DEALING WITH, I HOPE YOU ARE HANGING IN AND DOING WELL DURING THIS TIME. AS I GO THROUGH THE DIRECTOR'S REPORT PLEASE FEEL FREE TO PUT QUESTIONS AND COMMENTS IN THE CHAT AS ANNA MENTIONED, OUR DEPUTY DIRECTOR CLAIRE SCHMIDT AND ANN MIGHT BE TAG TEAM WITH COMMUNICATIONS EDUCATION, THEY WILL BE MONITORING THE DISCUSSION AND BE ABLE TO LOOK AT THE CHAT AND THE RAISED HANDS AND THEY WILL CALL ON YOU AT THE END OF THE REPORT AND HOPEFULLY HAVE GOOD AMOUNT OF TIME FOR DISCUSSION. PLEASE DO SO. FIRST I WANT TO RELAY SOME OF YOU MAY KNOW, NOT SURE IF CHRISTINA WILL BE ABLE TO MAKE IT TODAY, I HOPE SHE IS ON TODAY, SOME MAY KNOW KRISTINA HARTMAN IS NO LONGER AT THE ASSISTANCE FUND. THIS IS HER LAST OFFICIAL DAY ON OUR COUNCIL. SO WE ARE SAYING GOODBYE TO KRISTINA AND WISH HER WELL IN HER NEW POSITION AND HER NEW POSITION PRECLUDES HER SERVICE ON COUNCIL SO I KNOW THOUGH THAT WE WILL CONTINUE TO WORK WITH KRISTINA IN A VARIETY OF OTHER CAPACITIES. I KNOW SHE WILL CONTINUE TO CONTINUE TO GIVE TO THE SCIENTIFIC IMMUNITY, WE LOOK FORWARD TO WORKING WITH YOU AND YOUR NEW ROLE. >> THANK YOU, JONI. >> GLAD YOU MADE IT. NICE TO SEE YOU. SEVERAL NIH TRANSITION LEADERSHIP TOO. DR. COLLINS STEPPED DOWN AS DIRECTOR OF THE NIH. HE WAS THE LONGEST SERVING NIH DIRECTOR AND SERVED THREE PRESIDENTS. AND IN CASE YOU MISSED IT, THERE WAS A WONDERFUL TRIBUTE TO DR. COLLINS AND THE LINK IS SHOWN HERE BELOW. THERE WERE VARIETY OF FAIR WELL MESSAGES FROM LUMINARY SCIENTISTS, LIKE JANE GOODALL TO PRESIDENTS AND VICE PRESIDENTS AND POLITICIANS TO CO-MEDIANS AND ACTORS AND MUSICIANS. SO IT WAS REALLY A WONDERFUL EVENT SO IF YOU HAVEN'T HAD A CHANCE PLEASE TAKE A LOOK. AND AS DR. COLLINS WAS GOING THROUGH THIS FAIR WELL TOUR HE ALSO CONDUCTED AN INTERVIEW PUBLISHED IN JAMA, HE WAS ASKED ABOUT HIS TOP THREE SCIENTIFIC ACCOMPLISHMENTS. HIS RESPONSE INCLUDED THE FOUNDING OF NCATS AMONG THE TOP THREE ACCOMPLISHMENTS. I CERTAINLY COULDN'T AGREE MORE, COULDN'T BE MORE PROUD OF THAT. WITH THE VISION OF HIS VISION FORMING NCATS AND THEN CHRIS AUSTIN'S LEADERSHIP THE LAST TEN YEARS IT IS BUILT NCATS FROM GROUND UP AND NOW IT HAS COME INTO ITS OWN. IT IS I THINK EXCITING FOR US TO BE AND I HOPE YOU ARE AS EXCITED AS I AM TO CONSIDER THE NEXT DECADE OF WHAT NCATS IS DOING FOR TRANSLATION SCIENCE AND RARE DISEASE RESEARCH AS WELL. SO I WANTED TO DEFINITELY CALL THAT OUT FOR YOU TODAY. THE POSITION OF DIRECTOR IS PRESIDENTIALLY APPOINTED AND ALSO SENATE CONFIRMED. THIS PROCESS IS WHOLLY OWNED BY THE WHITE HOUSE. NIH IS NOT INVOLVED AT ALL SO WE WON'T HAVE ANY EXTRA RUMORS OR ANY IDEAS FOR THAT MATTER. NO CANDIDATES TO DATE HAVE BEEN PUT FORWARD BUT IN THE MEANTIME, THE PRESIDENT HAS ASKED DR. LARRY TABAK TO BE ACTING NIH DIRECTOR AND HE SERVED AS THE NIH PRINCIPLE DEPUTY DIRECTOR WITH DR. COLLINS. ALONG WITH THAT DR. TARA SCHWETZ HAS TAKEN HIS PLACE AS ACTING NIH PRINCIPLE DEPUTY DIRECTOR. MORE TO COME AS WE HEAR NEWS AND WE WILL HEAR ABOUT IT AT THE SAME TIME SO STAY TUNED. OPEN SEARCHES, THE NCATS DIRECTOR POSITION HAS BEEN POSTED SINCE WE LAST MET. THIS ONE DOES NOT REQUIRE A PRESIDENTIAL APPOINTMENT OR SENATE CONFIRMATION. BUT SIMILAR TO THE NIH DIRECTOR POSITION THIS ONE IS ALSO NOT WHOLLY OWNED BY NCATS. THE SEARCH FOR THIS POSITION IS CONDUCTED BY THE NIH DIRECTORS OFFICE. THIS IS THE ANNOUNCEMENT ON THE SCREEN, IT APPEARED IN A NUMBER OF VENUES. IT IS OPEN UNTIL THE END OF THIS MONTH, JANUARY 31ST AND SO PLEASE HELP SPREAD THE WORD AND WITH ANY LUCK WE'LL HAVE AN UPDATE IN MAY I HOPE ON THIS PROCESS AS WELCH FEW OTHER NCATS POSITIONS UNDERGOING TRANSITION THAT I WANT TO TELL YOU ABOUT. THE FIRST IS DR. ANTON HE'S BEEN IN THE ROLE FOR SEVEN YEARS AND HE DECIDED TO STEP DOWN TO FOCUS ON OTHER HATS HE WEARS IN THE N CATS LABS IN THE DIVISION OF PRE-CLINICAL INNOVATION. HE'S LOOKING FORWARD TO DEVOTING THE BULK OF TIME AT CHEMICAL GENOMICS BRANCH. WHERE HE'S BRANCH CHIEF OF THAT MANY THE N CATS LABS. BUT IN THE MEANTIME ANTON HAS GRACIOUSLY AGREED TO STAY ON AS SCIENTIFIC DIRECTOR UNTIL WE CONCLUDE A SEARCH. WITH THE NCATS DIRECTOR POSITION MOVING FORWARD IN PARALLEL WHICH HOPE TO BEGIN THE NATIONWIDE SEARCH FOR THE NEXT SCIENTIFIC DIRECTOR FOLLOWING THE, IN CATS SEARCH BY A FEW MONTHS. HOPEFULLY NOT TOO MUCH TIME. I I'M GRATEFUL WE WILL CONTINUE TO WORK WITH ANTON IN HIS ROLE AND HE'S BEEN REALLY A TERRIFIC PARTNER IN THINKING ABOUT HOW TO POSITION NCATS LABS GOING FORWARD. WE REMAIN IN GOOD HANDS AND CONGRATULATE ANTON FOR ALL THE WORK HE CONDUCTED MAKING THE NCATS LABS WHAT IT IS NOW, REALLY SUPERMEN SUPER. I CAN'T BLAME HIM FOR WANTING TO BACK TO THE LAB EITHER. WAY TO GO,ANTON. THANK YOU. LASTLY, COURTROOM ANN PARISER IS RETIRING, I ASKED HER TO PRESENT TO COUNCIL, YOU WILL HEAR HER PRESENTATION TOMORROW. I ASKED HER TO PRESENT BECAUSE THERE IS INCREDIBLE PROGRESS SHE LED FOR OFFICE OF RARE DISEASE RESEARCH OVER LAST FIVE YEARS, SHE CAME TO NCATS FROM THE FDA TO LEAD THIS OFFICE. AND SINCE SHE ARRIVED SHE EXPANDED THE OFFICE SHE'S LED WORK TO DESCRIBE AND UNDERSTAND THE BURDEN OF RARE DISEASES. AND SHE'S DEVELOPED INCREDIBLE RELATIONSHIPS WITH W IN THE AS WELL AS ACROSS THE RARE DISEASE BIOMEDICAL SPACE TO DRIVE ALL AREAS AND MOST RECENTLY LED THE WORK FOR NCATS ORPHAN DRUG STATUS FOR ONE OF THE PAT TRIALS. SO WE ARE GOING TO MISS ANN'S LEADERSHIP AND PASSION FOR RARE DISEASE RESEARCH SO WE WISH HER WELL IN RETIREMENT TOO. DR. PJ BROOKS IS WITH ANN ALONG THE WAY AND I HAVE ASKED HIM TO STEP IN AS ACTING DIRECTOR UNTIL A SEARCH IS COMPLETE. SO THEY WILL TAG TEAM TOMORROW FOR THEIR PRESENTATION AS SORT OF A WARM HAND OFF. AS WITH THE SCIENTIFIC DIRECTOR TRANSITION THAT I MENTIONED BEFORE, THERE WILL BE A SEARCH FOR NEW DIRECTOR FOR OFFICE OF RARE DISEASE RESEARCH AS WELL. THAT WILL COMMENCE RELATIVELY -- AT SIMILAR TIME AS WE CONDUCT THESE OTHER SEARCHES. IN THE MEANTIME, WE WELCOME PJ IN THIS ACTING ROLE AND WE WON'T SKIP A BEAT WITH HIS LEADERSHIP THERE. SO THAT WAS A LOT OF PERSONNEL CHANGES AND THERE'S A LOT GOING ON WITH OTHER ANNOUNCEMENTS AND EVENTS I WILL RELAY. ALSO VERY EXCITING BECAUSE ONE IS TO REALLY RECOGNIZE AND CONGRATULATE OUR LEADERS IN THE NCATS AND CTSA COMMUNITY. SHERRY BURKIN ANDREA GARCIA, KEN MANDL AND LIZ MCNALLY AND KEITH NORRIS, AND MARCELLA SMITH, IT UNDERSCORES THE IMPORTANT WORK WE DO SO CONGRATULATIONS TO ALL THESE FOLKS. IN THE SAME VEIN, COLLEEN KELLY, MEGAN SRINIVAS AND CH ARKANSAS YANG ARE ALSO RECOGNIZED FOR THEIR WORK WHAT THEIR ARE DOING NOW, SOME SCHOLARS AND TRAININGS AND DR. CHAO YANG IS IN COMMUNITY ENGAGEMENT, SELECTED AS PEOPLE, 40 PEOPLE WITHIN THEIR CATEGORIES WHO ARE UNDER 40. SO CONGRATULATIONS TO THEM, I THINK WE ARE DEFINITELY IN GOOD HANDS GOING FORWARD. RARE DISEASE DAY IS FEBRUARY 28, THE LINK AT THE BOTTOM TO REGISTER IF YOU HAVEN'T DONE SO ALREADY. IT IS REALLY A PACKED AGENDA, ADDRESSING DIVERSITY IN RARE DISEASE, RESEARCH INEQUITY OF CARE, IT IS ABOUT PERSONALIZED MEDICINE IMPORTANCE OF ADVOCACY AND COLLABORATIONS. NATURAL HISTORY DATA COLLECTION. FOR GENE THERAPY TRIALS. THE USE OF TELEHEALTH AND EFFORTS ON ADDRESSING THE DIAGNOSTIC ODYSSEY, THIS IS REALLY A I THINK A VERY EXCITING AGENDA WITH MEATY TOPICS REALLY PRIMING RELEVANT FOR WHAT WE DO SO HOPE YOU CAN JOIN US I GUARANTEE YOU THAT THIS WOULD BE ONE OF THE BEST MEETINGS YOU ATTEND ALL YEAR SO MAKE IT IF YOU CAN OR ALERT CUR COLLEAGUES AS WELL. SO FINALLY WE HAVE TALKED ABOUT ARPAH IN PREVIOUS MEETINGS. AND SO THIS ROUND I DECIDED DR. SCHWETZ IS NOW BACK TO NIH SO I ASKED TARA TO JOIN US TO GIVE UPDATE ON TOPIC OF ARPA H. SHE'S ACTING PRINCIPAL DEPUTY DIRECTOR BUT THE LAST SIX MONTHS SHE'S BEEN DETAILED TO THE OFFICE OF SCIENCE TECHNOLOGY AND POLICY AT OSTP. SHE'S WORKING VERY CLOSELY WITH DERRICK LANDER ON PLANNING ARPA H SO I WILL LET HER UPDATE. I DON'T WANT TO STEAL HER THUNDER. SHE WILL FOLLOW ME DIRECTLY. WAR PA THAT WILL BE THE NEXT TALK. TO ROUND OUT I HAVE A FEW UPDATES ON DIVERSITY AND EQUITY AND INCLUSION OR DEI EFFORT AT NCATS AND THE NIH. THE NIH IS HOLDING A SERIES OF LISTENING SESSIONS AND I HAPPEN TO HOLD ONE LAST WEEK FOR THE HEALTH CENTERS AN SYSTEMS, AND THERE'S ALSO A FEW COMING UP SO I PUT THOSE DATES HERE SO YOU CAN SEE THEM BUT THERE IS A LINK AT THE BOTTOM THAT YOU CAN CHECK INTO TO SEE OTHER ACTIVITIES THAT ARE GOING ON IN THIS SPACE AND REGISTER FOR ONE OF THESE ACTIVITIES IF YOU ARE ABLE TO. ENCOURAGE YOU TO JOIN OR SEND TO COLLEAGUES IF THEY ARE INTERESTED AS WELL. IN ADDITION TO THE UNITE EFFORTS WE ARE DOING AT NCATS WE ESTABLISHED AN INTERNAL DEIA HEALTH DISPARITIES GROUP TO BUILD AND SUSTAIN A WELCOMING AND INCLUSIVE ENVIRONMENT TO MAKE SURE THAT OUR PROCESSES AND OPERATIONS ARE ALL INCLUSIVE OF THAT HAVE THINKING AND JUST -- I GUESS IT WAS OVER THE SUMMER PROBABLY NOW WE ARE ALSO MAKING SURE THESE ARE IDEAS AND TOPICS THAT ARE DISCUSSED AT MEETINGS AND CONFERENCES THAT WE SUPPORT. ANY TOPICS THAT CAN COVER THE SCIENCE NEEDS TO ALSO ADDRESS HEALTH EQUITY IF THERE IS AN OPPORTUNITY TO DO SO. WE ENCOURAGE TO HAPPEN IN THEK SCIENTIFIC OFFICE AS WELL. ANOTHER CTSA INVESTIGATOR PUBLISHED A PIECE ABOUT DEI IN CLINICAL TRANSITIONOR RATIONAL RESEARCH AND THIS PAPER I DON'T HAVE A LINK BUT I DID PUT THE TITLE ON THE SLIDE HERE. THIS PAPER LAYS OUT A PATH FORWARD AND IT ALSO REPRESENTS I THINK A DEEPER EFFORT WITHIN THE STEERING COMMITTEE AS WELL AS CTSA COMMUNITY AS LARGE. THERE IS NOW A DEI TASK FORCE WITHIN THE STEERING COMMITTEE OF THE CTSA PROGRAM. A LOVE OF THE EFFORTS WITH THAT TASK FORCE BUT ALSO PRIOR TO THE DEVELOPMENT OF THAT TASK FORCE THERE'S BEING DISCUSSIONS WITH CTSA PROGRAM ABOUT THIS. THIS PARTICULAR PAPER I THINK IS A CULMINATION OF LOT OF THOSE DISCUSSIONS THAT TALKS ABOUT LEADERSHIP AND TRAINING AND RESEARCH AND CLINICAL TRIALS AND PROVIDES CONCRETE GOALS THAT TRANSFORM AND BUILD CAPACITY AS WELL AS BUILD TRUST. SO I'M COMMITTED TO TRANSLATING THESE SORTS OF EFFORTS INTO MEASURABLE ACTION AS WE GO FORWARD. I WANT TO SPEND A FEW SECONDS ON THE BUDGETS NOT MUCH TO RELAY SINCE THE LAST MEETING UNFORTUNATELY. THE CONTINUING RESOLUTION THAT WAS TO DECEMBER WAS REUPPED IF YOU WILL, WE HAVE A CONTINUING RESOLUTION THROUGH FEBRUARY 18. JUST REMINDER THAT THE FULL HOUSE VOTED AND APPROVED THEIR APPROPRIATIONS BILLS BACK IN JULY AND THE SENATE -- THEY COULDN'T AGREE ON THE TOP LINE APPROPRIATION NUMBERS BUT MAJORITY RELEASED DRAFT BILLS IN REPORTS FOR PUBLIC AWARENESS ON I THINK THAT WAS -- YEAH, OCTOBER 18. THESE BILLS HAVEN'T BEEN FORMALLY INTRODUCED. WE ARE HOPEFUL OVER THE NEXT COMING WEEKS WE WILL START TO SEE THAT MOVEMENT AND FEBRUARY IS GOING TO BE A CONFUSING MONTH, NOT ONLY IS THAT HAPPENING BUT ALSO THE PRESIDENT'S BUDGET COMES OUT EVERY FEBRUARY SO THE FY 23 BUDGET IS ANTICIPATED TO BE RELEASED IN EARLY FEBRUARY AS WELL. SO JUST STAY TUNED TO WHAT'S HAPPENING IN TERMS OF THE CONTINUING RESOLUTION AS WELL AS THE FY 22 BUDGET. I'M ALSO TAKING A MOMENT TO HIGHLIGHT SOME OF THE RESEARCH FUNDING OPPORTUNITIES THAT ARE CURRENTLY ON THE STREET. I WON'T WALK THROUGH ALL OF THESE BUT I WANTED YOU TO HAVE THIS LIST SO YOU WOULD BE ABLE TO LOOK AT THE DIFFERENT FUNDING ANNOUNCEMENT OPPORTUNITIES AND THE TITLES, IT REALLY HIGHLIGHTS THE BREADTH OF ACTIVITIES THAT WE ARE INVOLVED IN AND HOPE YOU AND COLLEAGUES CAN SPREAD THE WORD OR APPLY TO THESE ACTIVITIES. SO I WANT TO MOVE ON TO THE MORE SCIENCE PORTION OF MY REPORT AND WILL IS A LOT TO RELAY HERE BUT WANT TO GIVE A HEADS UP ON OTHER THINGS THAT WILL BE GIVING YOU UPDATES ON AS WE GO FORWARD. VALERIE GORDON WILL TALK ABOUT INCLUSION MONITORING REPORTS. THIS IS A REQUIREMENT FOR US TO RELAY TO YOU ON A, IT IS NOT A ROUTINE BASIS BUT IT IS A ROUTINE BASIS BUT NOT FREQUENT BASIS. SO SHE WILL TELL YOU ABOUT THAT REPORT AND WHY IT IS IMPORTANT THAT WE GET YOUR INPUT ON THAT. THEN AFTER VALERIE GOES LILY PORTILLA FROM OFFICE OF STRATEGIC ALLIANCE WHO WILL UPDATE ON ACTIVITIES IN HER OFFICE AND THEN AS I MENTIONED ANN AND PJ WILL BE TALKING ABOUT ACTIVITIES AROUND RARE DISEASE SPACE TOO. FINALLY KEITH WILL BE TALKING ABOUT A NEW APPROACH WE ARE TAKE FOGGER OUR ORGANIZATION OF NCATS, THAT IS ALSO SOMETHING WE NEED TO RELAY SO HE WILL TELL YOU ABOUT THAT MORE TOWARDS THE END. NOW I WANT TO DIVE INTO THE RESEARCH EFFORTS WE HAVE BEEN DOING. BEFORE I I SHOULD SAY BECAUSE OF THE NATURE OF NCATS OUR TEAM BASED APPROACH, OUR FOCUS ON PLATFORM TECHNOLOGIES, APPROACH ON RARE DISEASE AUTOMATION AND ROBOTICS ACTIVITIES EMPHASIS ON DATA SCIENCE AND OUR -- ALL HE IS LEAD TO OUR ABILITY TO RESPOND TO PUBLIC HEALTH EMERGENCIES, AND GET INVOLVED IN VARIETY OF DISEASE RELATED ACTIVES BUT CERTAINLY OVER THE LAST COUPLE OF YEARS IT HAS BEEN FOCUSED ON THIS -- THE COVID PUBLIC HEALTH EMERGENCY. ALL OF WHAT WE CAN BRING TO THE TABLE ARE QUINTESSENTIALLY NCATS SO I WILL GIVE YOU A SLIVER OF THE LARGER PIE OF ACTIVITIES WE DO NOW BECAUSE OF THE COVID RELATIONSHIP TO THOSE ACTIVITIES BUT IT DOES JUST REPRESENT A PIECE SLIVER OF WHAT WE ARE DOING. I WILL TELL YOU PROGRESS ON THE COVID WORK -- COVERING A VARIETY OF AREAS BUT WILL START WITH THE CLINICAL TRIALS AND THEN MOVE INTO THE ANTIVIRAL PROGRAM ON PANDEMICS AND DIVE INTO OUR ELECTRONIC HEALTH RECORD NATIONAL COVID COHORT COLLABORATIVE ACTIVITIES. THEN AT THE END OF THE TALK JUST GIVE YOU A FAIR WARNING, AT THE END OF THE TALK I WANT TO SWITCH GEARS THE LAST TEN OR SO MINUTES TO WALK THROUGH SOME HIGH LEVEL GOALS AND I WANT TO TACKLE OVER THE NEXT DECADE AND WITH WHAT I PRESENT TODAY I HOPE IT SERVE AS BROAD RANGE OF SCIENTIFIC PURSUIT AND THE GOALS OUTLINED EMBRACE THAT APPROACH AND WILL SERVE TO HELP DRIVE THAT SUCCESS AS WE GO FORWARD. SO FIRST UP OF COURSE IS THE -- I MENTION CLINICAL TRIALS. THE CTSA PROGRAM AGAIN HAS BEEN DOING THE LION'S SHARE OF THE COVID CLINICAL TRIAL WORK THROUGH THE ACTIVE PROGRAM THAT WE HAVE THROUGH THE FNIH AS WELL AS THE NIH AND VARIETY OF PRIVATE PARTNERS. WITH THIS PUBLIC PRIVATE PARTNER FRAMEWORK WE HAVE -- WE HAVE DONE A VARIETY OF CLINICAL TRIALS AND SOME OF THEM HAVE BEEN NCATS WHOLLY SUPPORTED LIKE THE CONVALESCENT PLASMA TRIALS BUT SOME THROUGH THE PUBLIC PRIVATE PARTNERSHIP THAT NCATS HAS SPONSORED. MOST MONEY COMING ARE NOT NCATS DOLLARS, THESE ARE DOLLARS (INAUDIBLE) RESPONSE. I'M GOING TO TALK ABOUT THE CONVALESCENT PLASMA TRIALS, THERE'S EARLY WORK COMING OUT, A BIGGER STORY TO TELL THAT WE WILL HEAR MORE OVER THE NEXT COMING MONTHS BUT THERE'S ONE REPORT OUT THAT I CAN TALK ABOUT RELATED TO THE CONTAIN TRIAL. I'M TALKING ABOUT SOME OF THE OTHER ACTIVITIES TOO. TESTIFY CONTAIN STUDY IS LOOKING AT EFFICACY OF COVID-19 CONVALESCENT PLASMA IN HOSPITALIZED PATIENTS. THIS IS OUT OF THE NEW YORK UNIVERSITY AND CTSA HUBS AND AFFILIATES WITH THEM. AND THE TOP LINE IS THAT CONVALESCENT PLASMA DID NOT MEET THE PRE-SPECIFIED CRITERIA FOR EFFICACY IN THIS STUDY. THEY WERE USING THE HUE SCORE FOR SEVERITY, 11 POINT SCALE WHERE 0 IS ASYMPTOMATIC AND 10 IS DEATH. AND THIS GRAPH HERE SHOWS THERE'S ODDS RATIOS POST TIER YEAR PROBABILITY ANALYSIS SO THAT RED LINE THERE IN THE MIDDLE IF YOU ARE TO THE LEFT OF THAT LINE THAT SHOWS A LITTLE BIT MORE BENEFIT, BUT FOR THIS THERE'S NO SIGNIFICANT BENEFIT THAT IS INDICATED IN GENERAL WITH CONVALESCENT PLASMA. BUT WHAT WAS INTERESTING IS WHAT THEY FOUND WHEN THEY DID SUBGROUP ANALYSIS IS THAT EARLY IN THE PANDEMIC WHEN THERE WERE NO TREATMENTS, IT SHOWED SOME EFFECTIVENESS IN THAT SUBGROUP ANALYSIS. HOWEVER, AS REMDESIVIR AND CORTICAL STEROIDS AND OTHER TYPES OF TREATMENT VACCINES ARE ON THE SCENE, IT HAS -- IT HAS WANED IN THAT BENEFIT SO THERE'S NO LONGER REALLY A BENEFIT FOR CONVALESCENT PLASMA THAT WE ARE SEEING NOW. THE CONVALESCENT PLASMA STORY ISN'T DONE YET SO KEEP YOUR EYE OUT FOR OTHER REPORTS COMING SOON FROM THE WORK WE SUPPORTED AS WELL. AS WELL AS OTHERS. ACTIVE ONE ENDED ENROLLMENT WITH THE LAST PATIENT FOLLOW-UPS THAT WILL HAPPEN IN FEBRUARY AND MARCH. THIS ACTIVE ONE STUDY LED BY BILL WASHINGTON UNIVERSITY ST. LOUIS CTSA ALONG WITH 30 OTHER CTSA SITES INVOLVED WITH OTHER SITES TOO. THIS IS A DOUBLE BLIND PLACEBO CONTROL TRIAL AND HOSPITALIZED PATIENTS WITH RANDOMIZED ACROSS THREE DIFFERENT IMMUNOMODULATORS. SENATE P -- SENEPIVEROC ENDED EARLY BUT TOP LINE RESULTS DID COMPLETE ENROLLMENT AND WE WILL BE HEARING MORE ABOUT THESE AROUND MAY OR SO WHEN WE GOT TO GET THAT DATA AND ANALYSIS COMPLETED. STAY TUNED IN MAY, HOPEFULLY WE'LL UPDATE THEN. ACTIVE 6 IS LED BY DUKE AND DCRI AS WELL AS VANDERBILT AS COORDINATING CENTER. IT IS AN OUTPATIENT TRIAL TO TEST EXISTING DRUGS APPROVED FOR OTHER INDICATIONS TO SEE IF THEY WERE BE REPURPOSED FOR COVID-19 SYMPTOM RELIEF. THIS PARTICULAR CLINICAL TRIAL IS LOOKING AT THREE MAIN DRUGS, IVERMECTIN AND FLUVOXAMINE. WE ARE SENDING THESE MEDICATIONS TO PATIENT HOME AND DO FOLLOW-UP ONLINE OR THROUGH TELEPHONE SURVEYS SO IT IS A UNIQUE TRIAL WITHIN THE ACTIVE PARTNERSHIP. BUT IT IS GOING VERY WELL AND TARGETED ENROLLMENT SHOULD BE MET BY END OF MAY, SORRY BY END OF I GUESS I'LL SAY SPRING, PROBABLY MARCH, APRIL MORE LIKELY. AND HOPEFULLY WE'LL BE ABLE TO GIVE MORE DETAILS ON THIS ACTIVITY IN OUR MAY COUNCIL. WE ARE ALSO RAMPING UP OUR ANTIVIRAL PROGRAM FOR PANDEMICS. THIS IS A COLLABORATION WITH M CATS, NIAID, AND BARTA AND THIS IS TO CREATE PHASE 2 TRIAL READY ANTIVIRALS FOR RAPID PANDEMIC RESPONSE SO THEY WILL GET THROUGH CERTAINLY AT LEAST PHASE 2 AND BE READY OR GET THROUGH PHASE 1 AND BE READY FOR PHASE 2 IN CASE THERE IS ANOTHER NEED FOR A PANDEMIC RESPONSE. WE HAVE DONE SURVEY OF VIRAL FAMILIES AND ESSENTIALLY SEVEN VIRAL FAMILIES THOUGHT TO BE OF THE HIGHEST FOR PANDEMIC POTENTIAL. SO THOSE ARE SHOWN HERE ON THE LEFT. GIVEN WE ARE CURRENTLY IN THE PANDEMIC OF THE CORONA VIRUS FAMILY, MOST OF THE WORK WE DO CURRENTLY IS RELATED TO CORONA VIRUS. SOME OF THE PROJECTS DOING TO DATE, ARE LISTED HERE WITH CLEAR CREEK BIO COLUMBIA UNIVERSITY AND NCATS SUPPORTING THESE ACTIVITIES AS WELL. WE ARE LOOKING AT THINGS LIKE PROTEASE INHIBITORS TO STOP VIRAL REPLICATION WAY TO STOP VIRAL REPLICATION AND INFECTIVITY. WE ARE ALSO LOOKING AT COUPLE OF ANALOGS RNA DEPENDENT RNA POLYMERASES, AND THESE SORTS OF INHIBITORS TO ALSO HELP PREVENT VIRAL REPLICATION. SO THESE ARE SOME OF THE PROJECTS IN THE WAY IN OUR NCATS LABS IS LEADING THIS EFFORT FOR NCATS. WE HAVE A GREAT TEAM PUSHING REALLY A LOT OF HE IS SORTS OF ACTIVITIES -- THESE SORTS OF ACTIVITIES AND WE ARE OPEN FOR BUSINESS SO ANY IDEAS ALONG THE WAY, WE ARE HAPPY TO HEAR ABOUT THEM. EXCITING STUFF AS THIS IS GETTING OFF THE GROUND. SO I WANT TO ALSO JUST SHOW YOU SOME OTHER ACTIVITIES THAT WE ARE DOING IN TERMS OF MAKING SURE DATA ARE READILY ACCESSIBLE AND AVAILABLE FOR SCIENTISTS AND RESEARCHERS AND OTHERS. WE ARE LEADING THIS EFFORT WITH THE ACTIVE GROUPS TO FOLLOW ALL THE ACTIVE RELATED ACTIVITIES AND VACCINES AND THERAPEUTICS. AND THIS IS SORT OF A ONE PLACE WE CAN GO TO EASY TO READ DATA IN THIS OPEN DATA PORTAL. IT IS ON OUR NCATS WEBSITE. IT IS -- SO JUST TO ORIENT YOU AT THE TOP CORNER WITH ALL THOSE LITTLE DOTS THAT ARE DIFFERENT COLORS THOSE REPRESENT THE DIFFERENT WAVES OF THE DIFFERENT VARIANTS OF THE VIRUS. ON THE LEFT-HAND SIDE, ALL THAT IS REALLY REPRESENTING JUST THE OMICRON WAVE DATA. SO ALL THE DATA WE COLLECTED AS OMICRON HAS COME ON TO SCENE AS RELATES TO THE VACCINES AND THE DIFFERENT MOAN:AL ANTIBODIES AS WELL AS OTHER THERAPEUTICS. SO ALL THOSE DOTS THERE ON THE RIGHT HAND SIDE INDICATE THAT ACTIVITY IS WANED BUT IF THE DOT IS COLORED ON THE LEFT-HAND SIDE, THAT MEANS NO REDUCTION IN BENEFIT AND THOSE ARE ACTUALLY VIABLE CANDIDATES FOR THERAPEUTICS TO HELP THE OMICRON PIECE OF THE PANDEMIC. ON THE RIGHT HAND SIDE SHOWS THE DIFFERENT KINDS OF ASSAYS THAT WE CONDUCT TO SHOW THIS VIABILITY EFFICACY, THESE TYPES OF MEDICATIONS. SO IT IS REALLY A GREAT RESOURCE TO LOOK, NOT JUST AT CURRENT RATE BUT ALSO THE OTHER WAVES TO SEE THE DIFFERENCES AND WHY IT IS VERY IMPORTANT WE HAVE THIS LARGE THERAPEUTICS PROGRAM, THAT IS HELPFUL AS WE MOVE FORWARD IN THIS PANDEMIC WHICH IT IS -- I DON'T KNOW THAT ANY OF US COULD HAVE PREDICTED IT WOULD BE HERE TODAY WHERE WE ARE SO I HOPE WE CAN CONTINUE TO MAKE THESE THINGS AVAILABLE AND CONTINUE THE ACTIVITIES GOING FORWARD. THE OTHER MAJOR AREA IS AS I TALKED BEFORE IS MAKING ELECTRONIC HEALTH RECORD INFORMATION AVAILABLE FOR STUDYING COVID-19. THIS IS A PARTNERSHIP WITH THE SAVE PROGRAM 2H ALONG WITH NATIONAL INSTITUTE ON GENERAL MEDICAL SCIENCES AND THE IDEA CLINICAL RESEARCH PROGRAM AS WELL AS NON-PROFIT HEALTH IT ORGANIZATION WORKING TO IMPROVE HEALTH EQUITY. NCATS IS JOINED UP WITH OTHER FEDERAL AGENCIES AS WELL FOR EXAMPLE THE FDA, OFFICE OF NATIONAL COORDINATOR FOR HEALTH INFORMATION AND TECHNOLOGY AS WELL AS BRTA AND A FEW OTHERS. TO DATE, THERE ARE NOW OVER 10 MILLION ELECTRONIC HEALTH RECORDS WITHIN THE DATA SET WITH 3.7 MILLION REPRESENTED COVID POSITIVE CASES. OVER 12 BILLION ROWS OF DATA WITH ENTIRE COMMUNITY WHO IS MAKING HEADWAY ON ORGANIZING AND ANALYZING THIS DATA. AND THERE IS A DASHBOARD HERE AT THE BOTTOM, A LINK THERE YOU CAN GO TO NCATS DASHBOARD AND YOU CAN SEE THIS DATA COLLECTED. BUT AS I MENTION 12 BILLION ROWS OF DATA SO THINK ABOUT THAT ROWS OF DATA, AND IF YOU RUN THE SPREADSHEET AND PRINT OUT THAT SPREADSHEET AND YOU THINK ABOUT EACH CELL IN A ROW IS PROBABLY AN INCH, THE AMOUNT OF DATA THAT IS BEING COLLECTED, IF YOU WERE TO TAKE THE PREED SHEET AND MAKE LINEAR ACROSS EACH ROW, THAT ROW WOULD GO AROUND THE EARTH MORE THAN THREE TIMES. SO I AM GLAD WE ARE DIGITAL, IT IS VERY HELPFUL BUT IT IS A LOT OF DATA BEING CHECKED AND REALLY IMPRESSIVE WORK THAT THIS GROUP HAS DONE. WE HAVE DONE BIT MORE TO AUGMENT DATA AS YOU MIGHT IMAGINE, ELECTRONIC HEALTH RECORDS CAN BE MESSY AND INCOMPLETE SO WE WANT TO MAKE SURE WE ARE DOING OUR DUE DILIGENCE TO GET AS MUCH INFORMATION AS POSSIBLE. SO WE HAVE THE DATA HERE IS NOT REALLY THAT CRITICAL BUT IT IS NOW INCLUDING MORTALITY DATA, IT IS INCLUDING VIRAL VARIANT SEQUENCE DATA SO WE KNOW WHICH VARIANTS PARTICULAR PEOPLE HAVE BEEN EXPOSED TO AND HOW THAT MIGHT DRIVE OUTCOMES. WE ARE GETTING CMS DATA WHICH INCLUDES CLAIMS DATA, PRESCRIPTIONS AND OTHER INDICATORS OF HEALTHCARE UTILIZATION. SO THESE ADDED ON DATA SETS WILL BE MADE AVAILABLE LIKELY STARTING IN BEGINNING OF FEBRUARY. AND WE ARE NOT DONE THERE, WE WANT TO GO AND THINK ABOUT WHAT IS NEXT SO WORKING TOWARD FIGURING WAYS OF OBTAINING ICU WAGE INFORMATION FORM AS WELL AS IMAGING DATA. SO WE HAVE REALLY MOVED THE BAR IN ADOPTING PRIVACY TECHNIQUESES TO ENABLE THIS TYPE OF ACTIVITY AND MAXIMIZE POTENTIAL OF THESE EXTERNAL DATA SETS AS WELL AS OTHER FUNDED REPOSITORIES LIKE THOSE BEING DEALT FOR RECOVER PROGRAM THAT POST ACUTE SEQUELAE OF COVID CONDUCTED OUT OF NHLBI WE ARE PARTNERING WITH THEM SO A VARIETY OF THINGS PULLED INTO AND I THINK THE IS MAKING THIS DATA SYSTEM VERY ROBUST. I WILL GIVE YOU A SENSE OF ACTIVITIES ONGOING IN A MOMENT BUT I WANT TO RELAY TWO MORE POINTS THAT ARE NEW RELATED TO THAT. ONE IS WORKING TOWARDS A TRIBAL CONSULTATION, WE HAVE BEEN WORKING THIS OVER A YEAR BUT THE REASON THAT IT TOOK A BIT TO GET THERE, THERE'S OTHER ACTIVITIES AROUND COVID THAT ARE ALSO TRIBAL CONSULTATION SO WE HAVE BEEN IN THE QUEUE AND IT IS NOW OUR TURN. THE REASON THIS IS IMPORTANT, WHEN WE GET TO DEMOGRAPHIC FROM DATA CONTRIBUTORS IT CONTAINS THE OMB RACE TABLES WHICH INCLUDES AMERICAN INDIAN ALASKA NATIVE OR AIAN DATA. THESE ARE SELF-IDENTIFIED OR PROVIDER IDENTIFIED CLASSIFICATION OF RACE FROM EXISTING DATA. WE DON'T RECEIVE TRIBAL AFFILIATION DATA, SIMPLY THE RACE TABLES WE GET. KEEPING INTEGRITY OF THE TRIBAL SOVEREIGNTY AND PRIVACY WHILE WE ARE WAITING TRIBAL CONSULTATION WE HAVE BEEN MEETING WITH OUR TRIBAL HEALTH RESEARCH OFFICE AND CENTERS ACROSS THE COUNTRY AND OTHER EXPERIENCED NIH POO TO DISCUSS OPTIONS WHAT WE CAN DO UNTIL WE HAVE THAT CONSULTATION. BASED ON DIVISION CUSHIONS WITH THE TRIBAL RESEARCH OFFICE, NCATS DECIDED AT THAT TIME OUTSET WHEN WE FIRST MADE THE DATA PUBLICLY AVAILABLE WE OBSCURED THE AIAN RACE DATA AS WELL AS OBSCURED THE 2,659 ZIP CODE DATA THAT OVERLAPS WITH TRIBAL LANDS TO PREVENT INFERENCE OF TRIBAL AFFILIATION. THESE ARE TWO APPROACHES WE CAN DO UNTIL WE HAVE TRIBAL CONSULTATION. WE LOOK FORWARD TO MEETING WITH TRIBAL LEADERS AND HAVE AN OPPORTUNITY TO PROVIDE WHETHER AND HOW TO UTILIZE THESE SORTS OF DATA AND (INAUDIBLE) WHICH MIGHT BENEFIT THE COMMUNITY AS WELL. IN FEBRUARY WE WILL BE HAVING THIS TRIBAL CONSULTATION AND VARIETY OF ACTIVITIES WILL FOLLOW SUIT. THE SECOND AND LAST UPDATE IS REALLY GIVE YOU A I WANT TO SHOW AN OPPORTUNITY THAT CAME ACROSS WITH US, THIS IS A REAL WORLD EVIDENCE STUDY OUT OF UNIVERSITY OF COLORADO BY THE INDIANS -- THEY ARE LOOKING AT EFFECTIVENESS OF TREATMENT WITH MONOCLONAL ANTIBODIES. THERE IS AN OPPORTUNITY HERE TO LOOK AT THE IMPACT OF VIRAL VARIANTS SPECIFICALLY ON MONOCLONAL ANTIBODY INTERVENTION. SO THIS IDEA CAME ACROSS BECAUSE OF DISCUSSION WE HAD WITH JANET WOOD COKE WHCOKC, ABOUTING DEPUTY COMMISSIONER OF THE FDA BUT ALSO WHITE HOUSE LEADING A LOT OF ACTIVITIES RELATED TO THE COVID RESPONSE. SO THIS CAME OUT OF JANET'S HEAD AND WE WANTED TO SEE THIS KIND OF STUDY HAPPEN. AND BECAUSE OF THE OPPORTUNITIES WE HAVE WITHIN NCATS THERE WAS A WAY TO GET GET COVID SPECIFIC FUNDS TO SUPPORT THIS KIND OF ACTIVITY. NOW BEHOLD THIS PROJECT IS ESSENTIALLY TO ENROLL 4,000 INDIVIDUALS SOME WHO RECEIVED MONOCLONAL ANTIBODIES AND SOME WHO DIDN'T AND FOLLOW THE INDIVIDUALS WITH TELEPHONE SURVEYS AND LIKE, WE ALSO RECEIVE ELECTRONIC HEALTH RECORD INFORMATION TOO. AND THIS IS A WAY FOR US TO DETERMINE THE EFFECTIVENESS OF THE TREATMENT AND PREVENTING HOSPITALIZATION AND ATTRACT -- TO TRACK THOSE LONGER TERM SYMPTOMS AS WELL. SO THE UNIVERSITY OF COLORADO TEAM RECOGNIZED THAT WE REALLY NEEDED TO UNDERSTAND WHO IS MORE AT RISK TO GET THE DISEASE AND MORE AT RISK TO BE HOSPITALIZED SO THAT THE LIMITED SUPPLY PERHAPS SOMETIMES OF THESE MONOCLONAL ANTIBODIES COULD BE USED AND DIRECTED EFFICIENTLY AND MOST EQUITABLY. SO THESE ARE THE DATA THAT I'M SHOWING HERE ON THE SCREEN, IT IS THIS IS OUT OF NET ARCHIVE, NOT PUBLISHED YET BUT IT IS PRE-PRINT SERVER ON MED ARCHIVES. SO STILL ONGOING BUT EARLIER RESULTS THESE ARE DATA THROUGH JULY SHOW IMPRESSIVE RESULTS BY DAY 28 FOR EXAMPLE, THIS FIRST RED LINE HERE, THE MONOCLONAL ANTIBODY SHOW 50% EFFECTIVENESS PREVENTING HOSPITALIZATION AND THEN DOWN AT BOTTOM YOU SEE IT IS QUITE EFFECTIVE IN TERMS OF THE LENGTH OF STAY AND MINIMIZING LENGTH OF STAY OF THOSE WHO ARE HOSPITALIZED. THEN THERE'S ALSO BY DAY 90 IN TERMS OF ALL CAUSE MORTALITY, THERE'S 83% EFFECTIVENESS IN PREVENTING DEATH. SO THESE ARE REALLY IMPORTANT DATA FOR US TO UNDERSTAND AND KNOW AND FIGURE HOW TO BEST USE THESE KINDS OF TREATMENTS IF THEY ARE IN LIMITED SUPPLY. SO WE LOOK FORWARD TO I HOPE BEING ABLE TO EXPAND SOME OF THIS WORK, AND ESPECIALLY AS THE PANDEMIC CONTINUES, THIS KIND OF INFORMATION IS VERY VALUABLE. THIS IS A LOT MORE WORK COMING OUT OF N 3C, HIGHLIGHT A FEW PAPERS HERE IN TERMS OF PUBLICATION AS WELL AS PRE-PRINT AND SOME OF THE NEWS OUTLETS CAPTURING A LOT OF THE WORK GOING ON IN NTC SO THAT'S EXCITING TO SEE THIS UPTAKE OF THIS PARTICULAR DATA SET, IT IS QUITE RICH AND IT IS GETTING RICHER WITH THAT INFORMATION I KNOW IT WILL BE VALUABLE. WITH THAT ADDED INFORMATION. IT IS HARD SOMETIMES GET MAGNITUDE ASIDE FROM THE FACT THE DATA GO AROUND EARTH THREE TIMES. LILY PORTILLA SENT ME NUMBERS OF AGREEMENTS IN SUPPORT OF N 3C THAT WE OBTAIN TO DATE, IT IS AMAZING, THIS IS TRULY AN ENTERPRISE LEVEL COLLABORATION WITH OVER 400 PAYMENTS IN PLACE THAT SUPPORT THIS WORK. SO I JUST GIVE YOU A SENSE OF THE MAGNITUDE OF THAT. SO I'M GOING TO SWITCH GEARS A LITTLE BIT NOW, I WANT TO CLOSE OUT BY TALKING ABOUT WHAT IS NEXT FOR NCATS. ON DECEMBER 7 AS YOU MAY HAVE REMEMBERED IT IS OUR BIRTHDAY, AND WE HAD OUR BIRTHDAY PARTY AND IT WAS JUST REALLY A WONDERFUL EVENT. WE HAD OUR 10TH ANNIVERSARY CELEBRATION WHICH WHERE WE HAD 771 ATTENDEES AND AVAILABLE ON DEMAND, YOU ARE WELCOME TO VIEW ON DEMAND AS WELL. BUT IT GAVE US AN OPPORTUNITY TO TAKE STOCK AND TALK ABOUT MANY OF THE PROGRAMS AND TOPICS THAT ARE LISTED HERE FROM PATIENT IMPACT TO DATA DRIVEN SOLUTIONS. IN ADDITION O THE COVID WORK WE HAVE BEEN DOING. WE TALKED TO SUMMARIZE IF YOU WILL, WE TALK ABOUT HOW TRANSITIONAL SCIENCE IS REALLY PROVEN ITSELF OVER AND OVER TO DRIVE INNOVATION AND LEAD TRANSFORMATIONAL APPROACHES THAT BRING US TO OUR ABILITY TO DO MORE PREDICTIVE PRE-CLINICAL PIPELINE DEVELOPMENT, TO EXPAND OUR REPERTOIRE IN TECHNOLOGIES, TO REVOLUTIONIZE DIAGNOSTIC TREATMENTS TO PRIORITIZE DEI AND ALL THE ACTIVITIES THAT WE SUPPORT. IN WAYS THAT WE TRAIN THE NEXT GENERATION OF SCIENTISTS AND ENGAGE OLD STAKEHOLDERS, SHOULDN'T SAY OLD BUT PERHAPS WHO HAVE BEEN OUR STAKEHOLDERS A FILE AND FINDING NEW ONES WE WANT TO BUILD THAT TRUST IN AND NOSHTURE RELATIONSHIPS GOING FORWARD. THIS IS THE WAY TO BRING YOUR TREATMENTS TO ALL PEOPLE MORE QUICKLY. THIS IS NOT JUST OUR MANTRA. THIS IS OUR VISION. WITH THAT VISION IT PROVIDED AN OPPORTUNITY TO LOOK AHEAD O THE NEXT DECADE, IN THE KEY NODE ADDRESS DURING THAT EVENT I SET FORTH THREE AUDACIOUS GOALS THAT ARE FORWARD-LOOKING AND I WANT TO SET A PATH NEXT DECADE HOW TO OBTAIN THEM. NCATS COUNCIL HEAR YOUR THOUGHTS AND REACTS AND AS WE GET A PERMANENT DIRECTOR, FOR NCATS THERE WILL BE AN OPPORTUNITY TO HONE AND DEVELOP AND METRACISE THESE MORE. BUT I WANT TO RUN LIEU THEM BECAUSE ED I WOULD LIKE YOUR REACTIONS SO GOAL NUMBER ONE, MORE TREATMENT. PERIOD. RIGHT NOW WE HAVE 5% DISEASE THAT HAVE A TREATMENT SHOWN HERE IN THAT -- THIS BOTTOM BAR HERE ON THE GRAPHIC WITH -- WE HAVE ABOUT -- WE KNOW THERE'S OVER 7,000 RARE DISEASE TO DATE BUT MORE ARE ON THE WAY. WE ONLY HAVE 500 THERAPIES SO 5% OF DISEASE HAVE A TREATMENT. LET'S WORK TO GET THAT NUMBER UP SO THAT A QUARTER OF KNOWN DISEASE HAVE A TREATMENT IN THE PIPELINE SO WE WENT 5% TO 25%. WE ALSO KNOW 90% OF DRUGS IN CLINICAL TRIALS PAIL BECAUSE OF THE LACK OF EFFICACY AND SAFETY CONCERNS. IN VITRO ASSAYS THAT RECAPITULATE HUMAN PHYSIOLOGY AND PATHOLOGY SHOW INCREDIBLE PROMISE BEING MORE PREDICTIVE OF TOXICITY AND EFFICACY IN HUMANS SO WE NEED TO REALLY ENABLE THAT KIND OF DEVELOPMENT AND THOSE TYPES OF TECHNOLOGIES TO HAVE A WIDE ARRAY OF RESOURCES THAT DON'T JUST MODEL TISSUES AND ORGANS BUT MODEL DIVERSITY OF INDIVIDUAL, MODEL GENETIC MAKE UP, ENVIRONMENTAL EXPOSURES. SO THERE'S MORE WORK TORR DO HERE. -- WORK TO DO HERE. THERE'S OTHER INITIATIVES AS WELL THAT WILL DEMOCRATIZE AND DISSEMINATE NEW TREATMENT APPROACHES, WE TALK ABOUT THE PAGT PROGRAM AND THERAPY CONSORTIUM. THE SOMATIC CELL GENE EDITING INITIATIVE; THESE ARE POISED TO TRANSPERFORM THE PIPELINE FOR GENE TARGETED THERAPIES BY BREAKING DOWN THE BARRIERS OF THE PRE-CLINICAL TO CLINICAL APPROACHES BUT ALSO ADDRESS THE MANUFACTURING AND THE REGULATORY HURDLES IN THE PIPELINE AND SO ANY RARE DISEASE CAUSE BY SINGLE GENETIC MUTATION WE HOPE WILL BE ABLE TO HAVE THE OPPORTUNITY TO GET FIXED BY SOME OF THESE. AND WHEN YOU THINK ABOUT 80% OF THE RARE DISEASE ARE CAUSED BY SINGLE GENE DISORDERS, THAT MAKES IT SO THAT IF THIS ONLY WORKS FOR HALF, THAT'S HUNDREDS OF DISEASES. THESE ARE WHY THE TYPES OF PROGRAMS WHAT WE DO AT N CATS WITH SRI AND ACADEMIA AND PATIENTS, PATIENT ADVOCACY GROUPS AND REGULATORS AND FEDERAL PARTNERS WHO COME TO IDENTIFY AND DIAGNOSE WHAT IS CAUSING THIS SLOW PACE OF TREATMENT AND DEVELOPMENT OF THE TREATMENT AND WE ARE WORKING HARD AND COLLABORATIVELY TO BUILD PROGRAMS THAT WILL BRING ABOUT THIS REVOLUTIONARY TRANSFORMATION SO THIS IS A MODEL THAT WE LOOK FORWARD TO. GOAL TWO ALL PEOPLE. WE WANT TO DRAMATICALLY INCREASE INCLUSIVITY IN ALL AREAS, WORK FORCE TRAINING RESEARCH CLINICAL TRIALS AND HEALTH OUTCOMES. AND JUST WHEN YOU THINK ABOUT COVID, VERY RECENT AND STARK EXAMPLES, ARE COMING OUT FROM COVID FOR SURE, BUT THE COVID-19 OCCURRENCE OF DEATH AMONG RACIAL ETHNIC POPULATIONS IN RURAL COMMUNITIES IN OUR COUNTRY HAVE BEEN ONE OF THE MOST PAINFUL ACTS TO SEE DURING THIS PANDEMIC. BLACK AND AFRICAN AMERICANS HISPANIC AND LATINO, AMERICAN INDIAN AND ALASKA NATIVE ARE CONTRACTING AND DYING FROM COVID-19 THAN WHITE ASIAN COUNTER PARTS IN THOSE POPULATIONS. THERE WAS A RECENT PRE-PRINT OUT OF THE NIGMS CTR PROGRAM USING M 3C SHOWING RATES IN RURAL COMMUNITIES ARE 40% HIGHER THAN IN OTHER COMMUNITIES. THIS IS A BIG DEAL. WE NEED TO ADDRESS IT, WE NEED TO DO BETTER. CTSA ACROSS THE COUNTRY PRIORITIZED ENGAGEMENT PARTNERSHIPS AND INNOVATING AROUND STRATEGIES THAT MEET PEOPLE WHERE THEY ARE, MOBILE VANS, COMMUNITY, CENTERS PLACES OF WORSHIP, GROCERY STORES LIBRARIES, ALL THOSE SORTS OF THINGS. THESE EFFORTS ARE MADE CTSA CORNERSTONE OF THE TRUSTED COMMUNITY PARTNERS THAT HAVE AND WE NEED TO ENABLE THEM MORE TO PIVOT RAPIDLY ON A VARIETY OF HEALTH OUTCOMES WE ARE INTERESTED IN PURSUING AS WELL. TALK ABOUT DEIA EFFORTS A BIT AGO AND THE POINT IS THAT STUDIES OF TOMORROW, WHAT WE DO IN THE NEXT DECADE ENSURE NO ONE IS LEFT BEHIND IN OUR PLANNING DESIGNING OUR IMPLEMENTING. RESEARCH IMPROVES LIVES FOR ALL. INCREASING DIVERSITY IN ALL WAYS IS GOAL NUMBER TWO. GOAL 3, MORE QUICKLY, WE WANT TO REDUCE THE TIME IT TAKES FOR A TREATMENT TO REACH THE MARKET BY HALF. IT TAKES 10 TO 15 YEARS AND $2.6 BILLION FOR DRUG TO MAKE IT TO MARKET. WHICH NEED REDUCE THAT TIME. TO DO THAT WE NEED TO FAIL FAST, EARLIER AND IMPORTANTLY WE NEED TO FAIL FORWARD AND THAT IS A KEY FACTOR BECAUSE WHEN YOU FAIL FORWARD YOU ARE TRIPPING OVER THE VULNERABILITIES THAT WE HAVE FOUND AND YOU CAN FIX THEM BUT YOU -- WHEN YOU FAIL FORWARD, YOU NOT HOLDING YOURSELF BACK YOU ARE FAILING FORWARD TO MAKE SURE YOU IDENTIFY THOSE VULNERABILITIES AND MITIGATE THAT RISK. IT IS IMPORTANT TO DO THAT. WE WANT TO PROMOTE EMPLOY MORE STRATEGIES ADDRESSING MANY DISEASES AT A TIME AND FINDING WHAT IS COMMON ACROSS DISEASE AND TARGETING THOSE UNDERLYING MECHANISMS. ON TOP OF THAT HAVE TRAINING THE NEXT GENERATION OF SCIENTISTS IS HUGELY IMPORTANT TO HELP RETHINK HOW WE TRAIN OUR SCIENTISTS AND ENCOURAGING TO THINK MORE REVOLUTIONARY AND TRANSFORMATIONAL TERMS AS OPPOSED TO MORE EVOLUTIONARY TERMS. FINDING COLLABORATION AND PART SHIPS ARE CRITICAL FOR NCATS AND WHAT WE DO AND WHEN WE THINK ABOUT EXECUTING AGREEMENTS THOSE CAN TAKE TIME SO WHAT WE HAVE BEEN ABLE TO DO IS QUICKLY LAUNCH COLLABORATION BECAUSE WE USE COLLABORATIVE THEM PLACE OR AGREEMENT THEM PLACE THAT ALLOW COLLABORATIONS TO HAPPEN ON ORDER OF HOURS, DAYS SOMETIMES BUT THERE'S BEEN A COUPLE OF THEM DONE ON HOURS AND NOT MONTHS. SO THIS TIME SAVING IS HUGELY IMPORTANT FOR US. THE COVID SCENARIO FOR THE CLINICAL TRIALS HAVE REALLY IDENTIFIED HOW MASTERED UMBRELLA PROTOCOLS ARE REALLY HELPING US TO BE CLINICAL TRIAL READY. THINKING SINGLE IRB REVIEW BOARDS AND ALLOWING THEM TO ACTIVATE MORE EFFICIENTLY AND ENROLL PARTICIPANTS SOONER, THESE ARE THE KEY ACTIVITIES. AT THE LAST COUNCIL I TALK DATA SCIENCE EFFORTS AND NEW TOOLS TO SEE PATTERNS OF BIG DATA THAT WE HAVEN'T SEEN BEFORE. OF COURSE N 3C SHOWS US WE CAN CATALYZE THE HEALTH DATA AS A PRINCIPLE THAT IS SOMETHING TO PUSH FOR ALL DISEASES. THINKING OTHER APPROACHES LIKE DRUG REPURPOSING, OF COURSE IF YOU CAN DO DRUG REPURPOSING CUT THAT TIME LINE TO COUPLE OF YEARS AS OPPOSED TO TEN YEARS THAT IT TAKES TO DEVELOP DRUGS BECAUSE WE KNOW A LOT ABOUT THOSE DRUGS BEING REPURPOSED, BEEN FDA APPROVED FOR EXAMPLE SO OTHER WAYS TO GAIN E FORB SHIES SO A LOT OF -- EFFICIENCIES. SO THESE ACTIVITIES ARE AROUND THAT APPROACH AND GOALS ARE ASPIRATIONAL BUT THE WHOLE IDEA IS TO BRING MORE TREATMENT TO ALL PEOPLE. AS I TALK TO OUR INTERNAL TEAM MORE ON THESE IDEAS IT IS CLEAR TO ME WE CAN MAKE HEADWAY ON THEM. IMPORTANTLY THE GOALS WE FINALIZE WILL GUIDE AND -- US TO THE NEXT DECADE AND KEEP US FOCUSED ON MAKING THESE GOALS A REALITY. SO I PLAN TO USE THESE TO ALSO HELP FRAME SOME OF THE SUCCESS THAT WE HAVE MADE, AND WITH THAT I'M INTERESTED IN YOUR THOUGHTS ON ALL THINGS WE DO TODAY AN ESPECIALLY AROUND THESE THREE AMBITIOUS AND AUDACIOUS GOALS. I WILL STOP HERE AND I'M GOING TO TURN IT OVER TO CLAIRE AND PENNY TO MANAGE THE DISCUSSION. THANK YOU VERY MUCH. I APPRECIATE YOUR ATTENTION. >> GREAT, JONI. THANKS SO MUCH. MS. KENNEDY, WOULD YOU LIKE TO VERBALIZE THE COMMENT YOU PUT IN THE CHAT BOX? >> SURE, I ALSO HAVE A QUESTION IF I CAN JUMP IN WITH THAT. I WANT TO THANK THOSE WHO ARE STEP DOWN FROM THEIR ROLES AND NCATS AND ESPECIALLY DR. PARISER ONER HER RETIREMENT FROM PUBLIC SERVICE AT NCATS AND PREVIOUSLY AT FDA WITHOUT A DOUBT HER SERVICE CHANGED OUR RARE DISEASE LANDSCAPE FOREVER SO I THINK WE NEED TO RECOGNIZE THAT AND ACKNOWLEDGE THAT WE HAVE A DEPTH OF GRATITUDE TO YOU. WE ARE REALLY EAGER TO CONTINUE TO WORK WITH DR. BROOKS WE KNOW A LOT OF MOMENTUM IN ORDR IS BECAUSE OF SHARED LEADERSHIP SO LOOKING FORWARD TO WORKING WITH BOTH OF YOU THROUGHOUT THIS TRANSITION AND DR. BROOKS IN THE MONTHS AND HOPEFULLY YEARS AHEAD. THANK YOU. I DID HAVE A QUESTION, IF I CAN DO THAT AS WELL. SO FIRST, THANK YOU FOR THIS WONDERFUL PRESENTATION, I FEEL LIKE I GET TO MAYBE HEAR YOU MONTHLY AND EVERY TIME THERE'S A LOT OF NEW INFORMATION THAT YOU BRING FORWARD AND A LOT OF GREAT PROGRESS. A COUPLE OF THINGS YOU PRESENTED SPEAKS OUT TO ME AS AGILITY OF NCATS AND THE ABILITY TO NCATS TO PIVOT. ONE EXAMPLE YOU GAVE WAS IN A CONVERSATION WITH DR. WOODCOCK, A CONCEPT AND IDEA SHE HAD HAS NOW COME TO FRUITION AND YOU ARE SOON GOING TO HAVE DATA AROUND REAL WORLD EVIDENCE. UTILIZING MONOCLONAL ANTIBODIES. THAT IS A QUICK PIVOT. ONE THOUGHT WE DON'T HAVE TO ANSWER HERE BUT ONE QUESTION IS HOW DO WE BETTER COMMUNICATE NOT JURY OUR IMMEDIATE STAKE HOLDERS BUT THE GENERAL PUCKLY THE IMPACT NCATS HAS ON ANSWERING SOME OF OUR URGENT PUBLIC HEALTH ISSUES. AND ADDRESSING SOME OF THOSE. SO THAT SERVES SORT OF STRIKESES ME AS NCATS IS ONE OF OUR BEST KEPT SECRETS AND ONE OF THE MOST POWERFUL RESOURCES AND TOOLS. AS YOU WERE PRESENTING THAT JUMPED OUT AT ME TIME AND AGAIN. THANK YOU FOR THE WORK YOU ARE LEADING. >> THANK YOU SO MUCH, ANNIE. ECHOING YOUR THANKS TO ANN PARISER, WHICH I COULDN'T AGREE MORE, YOUR QUESTIONS, I DON'T KNOW HOW TO ANSWER YOUR QUESTION. EXCEPT TO SAY THAT AGREE WE NEED TO THINK ABOUT WAYS TO COMMUNICATE THIS KIND OF INFORMATION, I THINK AT THIS STAGE HOW WE ARE GATHERING THIS INFORMATION AGAIN THE ONE I PRESENTED IN THERE WILL BE OPPORTUNITIES FOR US TO DO CERTAINLY PRESS RELEASES TO GET THAT INFORMATION OUT MORE AND BUT I THINK THERE IS MORE TO LEARN TOO IN TERMS OF HOW WE THINK ABOUT WHO IS GOING TO BE AT RISK OR HOSPITALIZATION, WHO WE NEED TO TARGET FOR THESE KINDS OF THERAPIES. AND NOT ONLY THAT, YOU MENTIONED THE PUBLIC COMMUNICATIONS BUT THERE'S ALSO THE PHYSICIAN COMMUNICATION, MONOCLONAL ANTIBODIES ARE NOT REALLY A WIDESPREAD THERAPEUTIC IN MANY SPACES SO THERE'S PHYSICIANS WHO DON'T KNOW A LOT ABOUT MONOCLONAL ANTIBODIES AND HOW THEY ARE USED AND WHY USEFUL FOR COVID-19. SO A LOT OF THE WORK THAT I THINK WE ARE FINDING IS HOW DO WE DO WE COMMUNICATE TO STAKEHOLDERS AND PHYSICIAN COMMUNITY SO THEY UNDERSTAND HOW TO USE THESE TYPES OF THERAPIES AND WHEN TO USE THEM AS WELL, RECOGNIZING THAT WITH DIFFERENT VIRAL VARIANTS YOU MIGHT HAVE DIFFERENT RESPOND -- HAVE DIFFERENT RESPONSES TO THE MONOCLONAL ANTIBODIES. SO THAT IS ONE THING. THE OTHER IDEA WE HAVE, I THINK WE DO A REALLY GOOD JOB COMMUNICATING TO SCIENTIFIC COMMUNITY, THROUGH THE OPEN DATA PORTAL BECAUSE PEOPLE CAN UNDERSTAND HOW TO READ THAT INFORMATION BUT WE TRY TO DO A GOOD JOB IN HOW WE DISPLAY THAT DATA TO MAKE IT AS EASILY DIGESTIBLE AS POSSIBLE. THE OPEN DATA PORTAL IS A WONDERFUL EXAMPLE OF THAT, IT IS EASY TO COMMUNICATE THAT. THEN THE QUESTION IS HOW DO WE THINK ABOUT COMMUNITIES AND I WOULD LOVE TO HEAR IDEAS THIS GROUP MIGHT HAVE TO BE ABLE TO DO MORE OUTREACH ON EDUCATING FOLKS AND PERHAPS THAT IS MORE WEB PAGES BUT THERE ARE OTHER MORE ACTIVE KINDS OF THINGS THAT WE CAN DO. SO I LIKE THAT IDEA, AS WE TALKED ABOUT MORE RECENT DATA FROM MONOCLONAL ANTIBODY DATA, WE ARE SEEING THAT SAME IDEA OF HOW DO WE THINK ABOUT THIS INFORMATION OUT THERE, DISSEMINATION IS A KEY ASPECTS OF WHAT WE DO. SO WE ARE TRYING TO FIGURE OUT THAT AS WELL. THAT IS A VERY GOOD POINT. >> DR. CRESLER WOULD YOU LIKE THE GO? >> THANK YOU FOR SHOWING HOW NCATS IS RESPONDING TO THE ACUTE NEEDS AT HAND AND STILL KEEP LONG TERM STRATEGY IN HAND AND REALLY WANT TO 5 TO 25% PUSH FOR DEVELOPING TREATMENTS. IT SOUNDS AUDACIOUS TO ACTUALLY IMPOSSIBLE TO DO AND I WILL COUNT ON THAT. BECAUSE WHAT WE ARE SEEING RIGHT NOW IS THAT WE ARE DEFINING AND REDEFINING HOW WE WORK WITH HUMANS AS OUR HEAT MAP AND CELL BASED -- WE ARE ALIGNING CIVIL AND MACHINERY AND MOST IMPORTANTLY WHY THEY FAIL. WHY IT MIGHT NOT BE POSSIBLE TO DEVELOP SPECIFIC TARGETED THERAPIES FOR TWO AND A HALF THOUSAND DISEASES AND I THINK WE HAVE ALL THE INSTRUMENT TIME AT HAND AND NCATS HAS THE TOOLS TO DEPLOY THEM, TO IDENTIFY SHARE COMMON PATHWAYS OF DISEASE MANIFESTATIONS WHICH CAN PREVENT A LESION WHICH WOULD CAUSE A PHENOTYPE IN THE PATIENTS TO REMAIN SUB CLINICAL. I KNOW THAT THAT HAS BEEN DISCUSSED INSIDE NCATS FOR QUITE A WHILE IN SEVERAL KNOWLEDGE ACTIVITIES, I HEADED THAT WAY BUT IT IS RARELY -- REALLY IMPRESSIVE TO SEE HOW QUICKLY DISEASE SPECIFIC ACTIVITIES IN THE CELL MAPPING WE ARE MAKING FOCUS TO IDENTIFY THESE PATIENT SPECIFIC CHANNELS AND HOW TO ENTERPEER WITH THEM IN A TRANS-- INTERFERE WITH A TRANSLATIONAL SENSE. THIS IS THE INSTITUTE WHO LEVERAGE ALL THEIR KNOWLEDGE AND EXOSOME DISCUSSIO DISCUSSIONS WITH VERY SPECIFIC APPLICATION ALREADY BUT I THINK WHATEVER YOU CAN PUSH BACK, THIS IS JUST ARBITRARY NUMBER, NO IT ACTUALLY ISN'T. >> >> SORRY ABOUT THAT MA,THIAS. THANK YOU SO MUCH FOR THOSE COMMENTS. I WAS WORRIED TOO THAT IT MIGHT BE -- THAT 25% NUMBER MIGHT BE TOO BIG BUT AT THE SAME TIME I AGREE WITH YOU. I THINK WE HAVE TO GO FOR IT. YOUR POINT ABOUT THE SUB CLINICAL UNDERSTANDING OF THOSE END POINTS IS ALSO IMPORTANT AND I THINK WITH THE IN VITRO ASSAYS THAT WE CAN PUT TOGETHER PRINTING AND TISSUE CHIPS WE ARE USING, IT IS ALSO TO START IDENTIFYING WHAT THE SUB CLINICAL PHENOTYPES ARE AS BIOMARKERS THAT CAN BECOME SOMETHING USED CHUNKILY AND AN AREA WE WILL TRY TO DRIVE FORWARD AS WELL. APPRECIATE YOUR COMMENTS. >> THAT WAS TERRIFIC. THANK YOU SO MUCH. WHAT I WOULD LIKE TO EMPHASIZE, WE ARE ALMOST SEEING EMERGENCE OF NEW TYPE OF FIELD OF MEDICINE. WHICH IS AROUND SMALL PATIENT GROUP POPULATIONS WHO HAVE YOU BEEN SUBDIVIDED BY MOLECULAR AND OTHER TYPES AND THE RARE DISEASE FIELD THAT I LIVE IN, WE ARE LITERALLY SEEING 11 NEW CONDITIONS A WEEK. WHEN YOU LOOK AT THE LINKING OF GENETIC VARIATION TO THAT. THAT REALLY DOESN'T FIT THE CLASSIC MODEL, THE STATISTICS ARE DIFFERENT, THE EVIDENTIARY PROOF IS DIFFERENT. THE CLINICAL TRIALS MODELS AND THERE'S REALLY M CATS IS BETTER POSITIONED TO DEAL WITH THIS AND TO LEAD THE WAY THAN ANY OTHER GROUP. BECAUSE IT IS DISEASE AGNOSTIC TO A CERTAIN EXTENT. THE METHODOLOGIES THAT APPLY TO THESE SMALL GROUPS CAN GO ACROSS MULTIPLES BUT WE NEED A HOMING TOOL -- WE ARE BUILDING A TOOLBOX, WE HAVE TO CONTINUE TO BUILD THAT. SO THE ONLY THING I WOULD ADD ON TOP OF THAT VERY GOOD PRESENTATION IS BUCKLE UP BUT ALSO IT IS VERY IMPORTANT TO ENGAGE THE FDA CONSISTENTLY AND ACTIVELY. BECAUSE IF WE DON'T A LOT OF THE WORK THAT WE DO IS GOING TO BE WAISTED WHEN PEOPLE HAVE TO GO BACK AND USE A DIFFERENT CLASSIC MODEL WHEN TAKING TRIALS THROUGH FOR APPROVAL. >> THAT IS A GREAT POINT, MARSHALL. THANK YOU FOR BRINGING UP THAT SPECIFIC ISSUE AROUND THE FDA AND I'M GRATEFUL FOR THE WORK THAT THE FDA DOES AND THEY -- THEY WORK HAND IN HAND WITH US ALONG THE WAY. CASE IN POINT THAT I WOULD SAY IS WITH THE SPOKE GENE THERAPY CONSORTIUM, THIS IS ANOTHER ONE OF THESE PUBLIC PRIVATE PARTNERSHIPS THAT WE DO WITHIN THE NIH DUE TO THE ACCELERATED MEDICINE PROGRAM. FOR THAT PARTICULAR PROGRAM FDA IS IN IT FROM THE BEGINNING. AND THEY ARE HELPING US BUILD IT AND DEVELOP THE FRAMEWORK FOR IT BECAUSE IT IS NOT JUST ABOUT THE SCIENCE THAT WE NEED TO SUPPORT IN TERMS OF UNDERSTANDING THE ADENOASSOCIATED VIRAL THERAPIES BUT IT IS ALSO THAT WE NEED TO FIGURE OUT THAT MODEL OF HOW TO WORK THROUGH REGULATORY SPACE SO THAT IT IS NOT JUST A ONE OFF, IT IS A PLATFORM TECHNOLOGY. I THINK THE DISCUSSION WE HAVE HAD WITH PETER MARKS AT THE FDA HAVE BEEN REALLY EXCITING THAT THEY ARE VERY MUCH INTO THAT KIND OF IDEA AND WE LOOK FORWARD TO WORKING THROUGH THAT THAT PLATFORM IN AND OF ITSELF FOR SPOKE GENE THERAPY PROGRAM BUT IF IT WORKS IT BECOMES A BIGGER PLATFORM WHICH YOU CAN APPLY OLGONUCLEOTIDE TYPES OR OTHER THINGS SO IT WILL BECOME A PLATFORM OF PLATFORMS AND I THINK THAT'S REALLY EXCITING. >> ONE MORE THING TOO, I SAT ON COUPLE OF FDA COMMITTEES WHERE WE TALK ABOUT HOW WE IN THE MODERN AGE HOW WE DO CLINICAL TRIALS AROUND THESE. THERE'S ANOTHER SIDE TOO, NOT JUST WHAT WE ARE GIVING TO PATIENTS IS HOW WE ARE TESTING THE OUTCOMES. WE NEED A NEW SET OF TOOLS THAT ARE MORE DESIGNED AROUND PATIENTS WHO ARE GEOGRAPHICALLY SEPARATED IN OTHER WORDS ONLINE DIGITAL TOOLS AND COVID TAUGHT US NOTHING ELSE CONCERNING MOST EVERY NIH PROTOCOL WAS FULL OF PROTOCOL VIOLATIONS BECAUSE PATIENTS COULDN'T COME IN ANY MORE FOR THINGS BUT NONE OF THE TOOLS ARE VALIDATED SO THERE IS A LOT OF ROOM FOR PARTNERSHIP ON DEVELOPING TOOLS, VALIDATING THE TOOLS. SO THAT NOT ONLY CAN WE PROVIDE PLATFORMS LIKE OUR GENE THERAPY BUT ALSO WE HAVE WAYS TO SAY OKAY IS IT EFFICACIOUS, AND CAN WE DO THAT IN A WAY THAT ISN'T GOING TO CRUSH THE FAMILIES AND PATIENTS. THEY ALREADY GOT ENOUGH ON THEIR PLATE ALREADY. >> ABSOLUTELY. AND AS YOU KNOW, THEY ARE THE ONES DOING ALL THE MONEY RAISING AND FOR HERMING THOSE PARTICULAR DISEASE, IF THIS WORKS IT WOULD BE A HUGE BURDEN OFF OF THEIR SHOULDERS. >> VERY EXCITING. THANK YOU. >> DR. HARRIS, YOU ARE NEXT. >> THANK YOU. ECHO OTHER COMMENTS THAT GREAT PRESENTATION, LOVE THE GOALS. I SORT OF FOCUS ON THE MORE PEOPLE AND THINKING ABOUT THE FACT THAT GIVEN WORK YOU GUYS HAVE DONE WITH N 3C NHLBI HAS DONE WITH BIODATA CATALYST AND THIS IS A NEW ERA WE ARE IN AND IT DEMOCK TIDESES ACCESS TO SOME RESOURCES THAT WERE UNHEARD OF A DECADE AGO. BUT I THINK TO MAKE IT REALLY WORK, WE NEED TO THINK ABOUT INVESTING IN THE WORK FORCE AND MAKING SURE THAT PEOPLE ARE DATA PROFICIENT AND INVEST IN WHAT YOU CALL TRANSLATORS OR MATCH MAKERS, BEING ABLE TO PAIR DATA SCIENTISTS WITH CLINICAL EXPERTS WITH COMMUNITY ENGAGEMENT EXPERTS, ET CETERA. THAT IS GOING TO BE NEEDED TO TAKE US FROM WHERE WE ARE TO WHERE WE COULD BE BUT SO JUST ENCOURAGE US ALL TO BE THINKING STRATEGICALLY ABOUT THAT SORT OF WORK. >> GREAT IDEA. WITHIN THE N 3C WHAT I DON'T TALK ABOUT TOO MUCH IS THERE ARE THINGS CALLED DOMAIN TEAMS. THE IDEA BEHIND IT, IT'S GETTING TO THAT, IT IS ABOUT PAIRING STATISTICIAN WITH CLINICIAN ON A PARTICULAR OUTCOME THEY MIGHT BE LOOKING AT BUT A STATISTICIAN IS NOT GOING TO KNOW WHETHER IS IMPORTANT IN TERMS OF UNDERSTANDING END POINTS SO DOING THAT KIND OF PAIRING IS GOOD BUT WHAT YOU ARE SAYING IS THAT -- THAT MIGHT BE NECESSARY BUT IT IS NOT SUFFICIENT. I THINK YOU ARE RIGHT, WE HAVE BEEN THINKING ABOUT THIS, WE HAVE BEEN PARTNERING WITH NIH AND THE OFFICE OF DATA SCIENCE AND STRATEGY, THEY ARE DOING A VARIETY OF PROGRAMS ON SOMETHING CALLED IN THE HEAD TRYING TO MAKE SURE THEY ARE TOOLS AND RESOURCES AVAILABLE FOR ALL COMMUNITIES TO BE MORE DATA PROFICIENT BUT EVEN THERE I FEAR IT IS NECESSARY BUT NOT SUFFICIENT SO THAT IS SOMETHING TO KEEP UPDATED ON, IT IS A VERY ASTUTE POINT AND I WROTE IT DOWN. THANK YOU. >> DR. JACKSON. >> HI, JONI. THANK YOU FOR THAT OVERVIEW AND TOUCHING SOME OF THE HIGHLIGHTS OVER THE LAST SEVERAL MONTHS. I GUESS I WANT TO FOLLOW-UP ON PAUL. SO I HAVE TO MAKE SURE I RAISE MY HAND BEFORE PAUL SO HE DOESN'T FEEL WHAT I WAS GOING SO SAY BUT IT IS ALSO AROUND SAME CONCEPT OF ALL PEOPLE AND DATA DEMOCRATIZATION. I WONDER WHAT ARE KIND OF THE EFFORTS THAT ARE GOING TO BE GOING FORWARD WITH N CATS SPECIFICALLY AROUND DATA EQUITY ACCESSIBILITY PARTICULARLY FOR COMMUNITY STAKEHOLDERS, AND OTHERS REDUCING BIAS WITH DATA FROM INCEPTION TO FINAL ANALYSIS. THEN ADDRESSING SOME OF THE ISSUES AROUND DIGITAL EQUITY AS WELL. ARE THESE AREAS THAT NCATS IN FACT TAKE SOME LEADERSHIP BOTH AROUND THE RARE DISEASE BUT BROADLY AROUND TRANSLATIONAL SCIENCE, BECAUSE IT IS THE QUALITY OF OUR DATA, DON'T INCLUDE KIND OF THE BREADTH OF OTHER THINGS THAT IMPACT HUMAN HEALTH, THEN WE WILL CONTINUE TO MAKE ERRORS AS WE MOVE FORWARD NOT UNDERSTANDING EVERYTHING FROM EXOSOME ALL THE WAY THROUGH SOCIAL DETERMINANTS OF HEALTH OR EVEN ISSUES ASSOCIATED WITH STRUCTURAL RACISM. >> THANK YOU FOR BRINGING THAT UP. THE SHORT ANSWER IS THAT AT NCATS WE HAVE JUST STARTED TO -- MAYBE THIS IS THE LONG ANSWER. SHORT ANSWER YES. THE LONG ANSWER THOUGH IS MORE INTERESTING. WE JUST STARTED TO BUILD A REALLY DEEP AND WIDE FOCUS ON DATA SCIENCE. AND WE HAVE A DATA SCIENCE LEAD THAT IS MANAGING ACROSS THE NCATS AND A LITTLE BIT ABOUT WHAT WE HAVE COME UP WITH, WE HAD A RETREAT TO TALK ABOUT DATA SCIENCE AND WE ARE NOW HAVING A FOCUSED EFFORT IN THE TYPES OF DATA SETS AND RESOURCES THAT WE HAVE. ABLE TO MAKE SURE THAT -- AVAILABLE. TO MAKE SURE WE ARE TALKING ABOUT THE IDEA OF TRANSPARENCY AND WHAT IS IN THE DATA HOW TO UNDERSTAND WHAT IS IN THE DATA. ALSO TO MAKE SURE THAT WE CAN IDENTIFY BIASES IF THEY ARE IN THE DATA. IF YOU KNOW AND IDENTIFY YOU CAN INTERPRET THINGS BETTER. THE WHOLE IDEA OF COURSE THEN TOO IS UNDERSTAND WHAT BIASES ARE SO YOU CAN ADDRESS THEM AND BRING MORE DATA INTO EVALUATE THAT. I WILL SAY ONE OF THE THINGS FOR THE N 3C WE HAVE BEEN WORKING ON, IS A MORE CONCRETE EXAMPLE WE REALLY WANTED TO WORK WITH -- BECAUSE THE DATA TYPES THEY ARE BRINGING IN ARE AREAS MORE UNDERSERVED SO WE WANTED TO MAKE SURE WE -- THAT TYPE OF DATA WAS REPRESENTED IN THE N 3C COHORT. EVEN THEN I THINK WE STILL NEED TO DO A BETTER JOB AND ENSURE THAT WE ARE GETTING THAT DISTRIBUTION AND REPRESENTATION OF THE UNITED STATES SO THAT WE HAVE THAT DATA TRANSPARENCY SO THAT THINGS WE INTERPRET FROM THE STUDIES THAT WE DO ARE GENERALIZABLE IN A WAY. AND I THINK THAT IS SO IMPORTANT. AND THIS GOES BACK TO WHY I THINK I'M EXCITED ABOUT THE TRIBAL CONSULTATION WE ARE ABOUT TO HAVE THAWS BAY IS ANOTHER AREA WE NEED TO BOLSTER AND SUPPORT BUT ALSO RECOGNIZE THAT THE -- THEY HAVE TRIBAL SOVEREIGNTY OVER DATA THEY HAVE. AND WE WANT TO MAKE SURE WE ARE HONORING THAT AND RECOGNIZING THAT. SO WE WANT TO USE THAT VERY WELL, AND SO THAT THAT COMMUNITY THEN CAN TAKE A LOOK AT THE DATA AND APPLY IT NECESSARILY TO HELP THEM THINK ABOUT WHAT KINDS OF RESOURCES THEY MIGHT NEED GIVEN SPECIFIC SCENARIOS IN THAT COMMUNITY AND THINK ABOUT DOING THAT AS WELL. SO THIS IDEA OF BIAS IS SOMETHING WE THINK ABOUT AND TALK ABOUT A LOT AND I AM -- THIS IS -- I THINK OVER THE NEXT YEAR AT N CATS DATA SCIENCE AND THIS PARTICULAR IDEA IS ONE OF THE BIGGER THINGS THAT WE WILL BE FOCUSING ON. >> MS. HARTMAN YOU ARE NEXT. >> THANK YOU. >> FEW FOR THE FAIR WELL, I'M SAD THIS IS MY LAST MEETING BUT LOOK FORWARD TO WORKING WITH ALL OF YOU MANY LEADING GOVERNMENT AFFAIRS FOR ALLIANCE FOR REGENERATIVE MEDICINE SO STILL IN THIS SPACE BUT I WANT TO COMMENT MORE WEARING MY HAT AS A RARE MOM, ONE OF THE MOST IMPORTANT THINGS I HAVE SEEN WORKING WITH NCATS HAS BEEN CHAMPIONSHIP RARE DISEASE. ANNIE SAID QUITE A BIT ABOUT THIS AND ECHOED COMMENTS AND SAME WITH MARSHALL SUMMERS RARE IS A PUBLIC HEALTH PRIORITY. THIS HAS BEEN AN ISSUE THAT WE HAVE BEEN TRYING TO PUSH WITH THE ASSISTANCE FUND WORKING CLOSELY WITH DR. SUMMER AND CHILDREN'S NATIONAL WORKING CLOSELY WITH ANNIE KENNEDY AND HER COLLEAGUES AT THE EVERY LIFE FOUNDATION AND THE REST OF THE RARE DISEASE COMMUNITY. NCATS HAS ALWAYS BEEN THE BIGGEST CHAMPION FOR RARE DISEASE. JONI YOUR LEADERSHIP IN THIS SPACE IS CRITICAL AND WE HOPE THIS WILL CONTINUE. PERSONALLY AND PROFESSIONALLY VERY IMPORTANT TO ME THAT THIS CONTINUES. I KNOW WE WILL HEAR FROM TARA ON ARPA H AND THIS IS AN ISSUE THE RARE COMMUNITY IS FOCUSED ON HOW TO ENSURE THAT RARE DISEASES ARE ALSO PRIORITIZED WITHIN ARPA H THE RARE DISEASE COMMUNITY THE ASSISTANCE FUND EVERY LIFE GLOBAL GENES RARE -- THE WHOLE SLEW OF ORGANIZATIONS PUT A WHITE PAPER TOGETHER, HAPPY TO SHARE IF YOU HAVEN'T SEEN IT, IT IS VERY SHORT BUT OUTLINES WHAT RARE DISEASE COMMUNITY WOULD LIKE TO SEE, ARPA H FOCUS ON AND WORK WITH NCATS GOING FORWARD. SOME OF THE RARE PARENTS AND I HAVE HAD A THE CUSHION ABOUT WHAT WAS RAISED IN -- DISCUSSION ABOUT WHAT WAS RAISED IN TERMS OF NIH AND FDA WORK CLOSE TOGETHER AND MAKING SURE THEY ARE WORKING WITH CMS SO THAT ONCE THESE DRUGS HIT THE MARKET PATIENTS CAN ACCESS THEM AS WELL AND THAT IS SOMETHING WE SPENT TIME ON AT THE ASSISTANCE FUND. WHEN IT COMES TO EVEN GETTING THESE DRUGS INTO THE PIPELINE AND THROUGH THE FDA, ONE CONVERSATION WE HAVE BEEN HAVING AS CAREGIVERS OF RARE DISEASE QUITE A BIT IS THE NEED FOR A NEW LOOK AT THE RISK CALCULATION THAT FDA IS USING. THIS IS SOMETHING A LOT OF US HAVE SPOKEN PUBLICLY ABOUT BUT THERE NEEDS TO BE A LARGER CONVERSATION. WHEN CHILDREN ARE DYING, THAT IS SOMETHING THAT THE FDA DOES UNDERSTAND. MANY OF YOU MAY REALIZE WITH MY SITUATION MY DAUGHTER HAS A SEVERE DEVELOPMENTAL DISABILITY. SO SHE'S ESSENTIALLY A PERPETUAL TODDLER, SHE CAN BARELY WALK, SHE CAN'T TALK, SHE'S GOING TO BE SIX SOON, SHE CANNOT COMPLETE ANY OF THE ACTIVITIES OF DAILY LIVING WITHOUT ASSISTANCE. IT IS VERY MUCH LIFE ALTERING. THE RISK CALCULATION FOR US IS ALSO VERY DIFFERENT. WE -- THERE WAS JUST A CONVERSATION THAT LUKE ROSEN RELEASED ABOUT HOW CAREGIVERS WOULD LIKE TO TIME OUR LEAVING THIS PLANET WITH OUR CHILDREN BECAUSE THE THOUGHT OF LEAVING THEM HERE ALONE IS TERRIFYING BECAUSE WE ARE NOT SET UP IN THIS SOCIETY TO CARE FOR THEM. IT IS IMPORTANT TO CONSIDER THIS RISK CALCULATION. FOR THESE CHILDREN AS WELL. BECAUSE RIGHT NOW, WE DON'T HAVE A GOOD SOLUTION. A LOT OF US ARE AWAKE A LOT OF NIGHTS THINKING ABOUT THIS. THE HOPE THAT THE SCIENCE WILL MOVE FORWARD IS CRITICAL. I'M ALSO HOPEFUL THAT WE'LL DO MORE WORK AND THIS IS NOT NCATS JOB BUT LOOKING HOW WE DO TAKE CARE OF THESE CHILDREN. THERE IS NOT ENOUGH OF THE -- IN THE WORLD TO CARE FOR THEM. WE DON'T WANT TO HAVE ANOTHER WILLOW BUTCH, THE INSTITUTION WHERE THEY ARE NOW DOING MY DAUGHTERS UNNATURAL HISTORY STUDY TRANSFORMED SINCE THE '80s. THESE ARE THINGS THAT NEED TO BE BROUGHT INTO THE OPEN. WE NEED DISCUSSION WITH THE PARENTS AND WITH THE CAREGIVERS. S ESPECIALLY FOR CHILDREN BRAIN ARE NOT WORKING CORRECTLY AND CANNOT SPEAK OR THINK FOR THEMSELVES. IT IS A SOCIETAL QUESTION. THAT I THINK WE REALLY NEED TO ADDRESS. ONE LAST THING, MY RESEARCH EMAILED US WORKING ON THE ARPA H GETTING PRY YOUR PHASE FOR ARPA H, HE SAID COLLEAGUES WERE ASKING HIM WHY WOULD WE FOCUS ON RARE DISEASES? WHY WOULDN'T WE FOCUS ON SOME MORE COMMON DISEASES? AND WHAT ALL OF US DISCUSSED AGAIN OFFLINE QUITE A BIT IS WE WOULD KILL FOR CORTICOSTEROIDS IF OUR KIDS HAD ASTHMA, KILL FOR INSULIN PUMPS LIKE IF YOU ARE DEALING WITH DIABETES, NOT TO SAY WE CAN'T DO BETTER IN THOSE SPACES BUT IF YOU CAN PERFORM BASIC ACTIVITIES OF DAILY LIVING, YOU HAVE GOT A HUGE STEP UP. SO I THINK WE CAN DO MORE WORK TO TRY TO GET PEOPLE TO THAT PLACE WHERE THEY CAN FUNCTION AT EVEN BASIC LEVEL IN SOCIETY AND THAT'S THE HOPE THE SCIENCE AND NCATS IS BRINGING TO US BUT I REALLY DO THINK BENEED TO HAVE NCATS PULL IN, YOU HAVE BEEN GOOD AT THIS, THE PATIENT CAREGIVER COMMUNITIES, MAKE SURE FDA IS REALLY LISTENING, MAKE SURE CMS IS REALLY LISTENING THE WHITE HOUSE IS LISTENING, AND THAT WE ARE MOVING THIS FIELD FORWARD AND WE ARE TAKING INTO ACCOUNT THAT PERSPECTIVE WHEN THINKING ABOUT RISK. ONE LAST THING, IN TERMS OF THE DATA DEMOCRATIZATION, I AGREE THAT IS SO CRITICAL. AND I'M THRILLED MY DAUGHTERS DISEASE DAY IS PARTICIPATING IN RARE X. THE DATA IS OWN AND AVAILABLE AND PATIENTS AND THEIR FAMILIES MAKE THE DECISION TO SHARE IT AND EVENTUALLY, I DON'T WANT TO PUT KELLY ON THE SPOT BUT SHE'S BEEN LEADING A LOT IN MAKING SURE,IOTONLY THAT PATIENTS OWN THEIR DATA BUT THAT THEY GET COMPENSATED FOR THEIR DATA. THAT IS IMPORTANT GOING TO THE FUTURE. WE KNOW THE STORY OF HENRY LACKS, IF THE PATIENTS THEMSELVES ARE THE ONES GENERATING THESE MILLIONS AND BILLIONS OF DOLLARS THAT SOME OF THOSE RESOURCES ARE COMING BACK FOR WHAT THEY PUT IN. THAT IT SEEMS TO ME TWO CENTS, HAPPY TO SHARE THE ARPA H WHITE PAPER BUT I THINK NCATS IS WELL-POSITIONED TO KEEP LEADING THIS DISCUSSION AND MOVING IT INTO THE 21ST CENTURY AND HOPEFULLY WILL HAVE 21ST SENT ARE I TREATMENTS AND CURES HITTING THE MARKET AND AVAILABLE FOR KIDS LIKE MY DAUGHTER AND MORE. THANK YOU. >> THANK YOU SO MUCH, REINFORCES WHY WE ARE GOING TO MISS YOU SO MUCH ON COUNCIL. HUE FOR JOINING US TODAY. VERY WELL SAID. ALL OF IT WAS WELL SAID AND WE DO HAVE TINA MORRISON HERE, I DON'T WANT IF YOU WANT TO RESPOND QUICKLY, YOU HAVE A COMMENT IN THE BOX. DO YOU WANT TO SAY SOMETHING AND UNMUTE YOURSELF? >> THANKS FOR THE CHANCE, I APPRECIATE IT. CAN YOU HEAR ME OKAY? >> WE CAN. YES. >> I AM GOING TO SHARE A LINK FROM THE RECENT SUMMIT SPONSORED BY THE CENTERS OF EXCELLENCE AND REGULATORY SCIENCE AND INNOVATION. THERE WAS A REALLY IMPORTANT PANEL DISCUSSION WITH FIVE FDA COMMISSIONERS THE CURRENT ACTING COMMISSIONER MODERATED THE SESSION JANET WOODCOCK AND ONE FASCINATING PIECE OF THE DISCUSSION WAS FOCUSING ON RARE DISEASE, TALKING ABOUT OUR RELATIONSHIP WITH CMS, AND PAYERS TO REALLY THINK ABOUT WHAT STRUCK ME JONI IN YOUR COMMENTS ABOUT GETTING MORE TREATMENT TO ALL PATIENTS, OR ALL PEOPLE, I FORGET YOUR EXACT VISION BUT THE THING THAT CAME TO MY MIND IS WE CAN DEVELOP THE TREATMENTS BUT WHAT IS THE ROLE OF NCATS AND HOW TO GET TO THE PATIENT AND A LOT OF THAT HAS TO DO WITH PAYERS AND CONVERSATION WITH START WITH CMS AND JUST THINKING THE ROLE FDA CAN PLAY IN HELPING THAT AND I KNOW THAT FDA HAS WORKED MY PAST EXPERIENCES COME FROM (INAUDIBLE) I WAS A REGULATOR THERE FOR SEVERAL YEARS. WE CONSTANTLY TALKED ABOUT THIS CONVERSATION THAT NEEDS TO HAPPEN BETWEEN FDA AND CMS AS A START TO SAY WHAT IS THE DATA FDA NEEDS? WHAT IS THE DATA CMS NEEDS? IS THERE WAY TO WORK TOGETHER SO THAT ONCE SOMETHING LEAVES FDA AND LANDS ON CMS DESK IS THERE A WAY FOR US TO ANSWER THOSE QUESTIONS FOR THEM IN THAT PASSING OF THE BATON WHERE WE WORK TOGETHER WHEN BATON IS PASSED AND WE SUPPORT CMS MISSION TO MAKE DECISIONS FASTER BECAUSE SOMETIMES THAT IS A HUGE HURDLE EVEN THE TREATMENTS ARE THERE PATIENTS STILL CAN'T GET THEM. >> THANK YOU SO MUCH FOR THOSE COMMENTS. I COULDN'T AGREE MORE, THE GOAL OR THE THREE GOALS I OUTLINE IN MANTRA OF MORE TREATMENT TO ALL PEOPLE MORE QUICKLY, THAT IS NCATS CAN'T DO THAT ALONE. IT IS ABOUT THE ENTIRE BIOMEDICAL SYSTEM COMING TOGETHER AND THE PATIENT AND PATIENT ADVOCACY GROUPS COMING TOGETHER. KRISTINA, I APPRECIATE YOUR THE WAY YOU CAN ARTICULATE THESE THINGS BECAUSE YOU ARE A RARE MOM AND YOU SEE THESE FIRSTHAND AND I THINK THAT IS VALUABLE TO BRING INTO THESE DISCUSSIONS. SO THAT WE CAN FIGHT THOSE -- THE OPERATIONAL PIECE OF THIS ARE SO IMPORTANT AND CRITICAL FOR US TO ADDRESS THE AT THE SAME TIME TIME WE ADDRESS SCIENCE. I. A A RARE KID I GUESS. I HAVEN'T THOUGHT ABOUT THAT HOW TO SAY THAT BUT HOW YOU PHRASE IT AS BEING A RARE MOM, IS SO COMPELLING. MY MOM HAD A RARE DISEASE, IT WASN'T A GENETIC DISEASE, IT WAS MORE DIFFERENT KINDS OF CANCER RELATED CONDITIONS BUT IT WAS A RARE DISEASE NONETHELESS SO THESE KINDS OF ISSUES ARE JUST REALLY IMPORTANT TO ME AND THE MORE WE BRING THESE PEOPLE AND COMMUNITIES TOGETHER OUR VOICES ARE GOING TO BE LOUDER AND LOUDER. AND WILL CREATE THAT SWELL OF OPPORTUNITIES COMMUNITY SO THAT WE CAN BE SUCCESSFUL FOR THESE GOALS. I THINK UNFORTUNATELY I HAVE TO CUT OFF OUR DISCUSSION BECAUSE WE DO HAVE OUR SPECIAL GUEST WHO HAS ARRIVED. TARA SCHWETZ, I HOPE YOU ARE ABLE TO BE ON SCREEN HERE. I WANT TO QUICKLY INTRODUCE TARA TARA. FOR MUCH OF 2021 LAST YEAR TARA SCHWETZ HAS BEEN ON DETAIL TO WHITE HOUSE OFFICE OF SCIENCE TECHNOLOGY AND POLICY AS THE ASSISTANT DIRECTOR FOR BIOMEDICAL SCIENCE INITIATIVES. IN THIS ROLE SHE'S LED THE EFFORTS TO STAND UP THE ADVANCE RESEARCH PROJECTS AGENCY HEALTH FOR ARPA H AND SHE'S BEEN WORKING WITHIN THE BIDEN ADMINISTRATION TO PROPOSE ASH PA H TO TACKLE SOME OF THESE ISSUES THAT WE HAVE BEEN TALKING ABOUT AS WELL. NOW SHE IS IN HER NEW ROLE AS ACTING PRINCIPAL DEPUTY DIRECTOR AT THE NIH SO WE ARE HAPPY TO HAVE TARA BACK AT THE NIH, BUT HER CONNECTIONS WITH THIS PARTICULAR ARPA H OSTP LIAISON AND DETAILING HAS -- I THINK WILL PROVE VERY BENEFICIAL AS WE GO FORWARD NO MATTER WHAT THAT MIGHT LOOK LIKE. SO TARA, I WILL TURN IT TO YOU AND HAVE YOU GIVE US A STATUS UPDATE ON WHAT YOU KNOW ABOUT ARPA H. THANK YOU SO MUCH FOR JOINING US. >> THAW FOR HAVING ME. I HOPE YOU CAN HEAR ME. I'M GOING TO PREFACE THIS I HAVE BEEN HAVING INTERNET TROUBLE ALL DAY ON AND OFF SO I HAVE BACK UPON BACK UP HERE IF I NEED TO SWITCH NETWORKS AND COMPUTERS AND EVERYTHING ELSE. I'M GLAD I WAS ABLE TO GET ON COUPLE OF MINUTES EARLY TO HEAR THE END OF THAT DISCUSSION BECAUSE I THINK THIS TIES SO NICELY WITH WHAT SOME OF THE ROLES THAT ARPA H CAN PLAY PARTICULARLY TO THE LAST COMMENTS BECAUSE I HOPE ARPA H IS A FACILITATOR BETWEEN THE RESEARCH EFFORTS COMING OUT WORKING WITH FDA AND CMS MORE CLOSELY, THAT WILL BE A CRITICAL ROLE: SO WE CAN HELP ADVANCE THAT AS ARPA H HOPEFULLY GETS PULLED TOGETHER AND IS ABLE GET LAUNCHED. I KNOW Y'ALL HEARD ABOUT ARPA H BEFORE AND CLEARLY BY DISCUSSION THIS IS NOTHING COMPLETELY NEW FOR ALL OF YOU BUT JUST TO SORT OF TAKE A STEP BACK AND ENSURE EVERYONE IS ON THE SAME PAGE, I WANT TO REMIND FOLKS ARPA H IS ADVANCE RESEARCH PRODUCT AGENCY FOR HEALTH. THIS IS BEING PROPOSED AS A NEW ENTITY THAT WILL EQUITABLY BENEFIT HEALTH OF ALL AMERICANS BY HELPING CATALYZE FULL BREAK THROUGH, THE SHORT AND SIMPLE OF IT. IF YOU CAN GO TO THE NEXT SLIDE. THINKING ABOUT WHAT COULD BE DONE AND WHAT HAS BEEN DONE OVER THE LAST SEVERAL DECADES. WE KNOW SCIENCE HAS DONE AMAZING THINGS. WE ARE AT THIS REALLY UNPRECEDENTED MOMENT OF PROGRESS PARTICULARLY AS WE ARE STILL MISPANDEMIC BUT WE HAVE BEEN ABLE THE SEE SOME AMAZING SCIENTIFIC WORK COME OUT OF WORK DONE AND SUPPORTED BY NCATS BUT IT TAKES CAUSES TAKE A STEP BACK AND SAY WHAT MORE CAN WE DO TO SPEED REVOLUTIONIZE AND TRANSFORM MEDICINE AND IMPROVE THE HEALTH OF ALL AMERICANS. SO IF WE IMAGINE FOR -- FOR INSTANCE, IF WE CAN PROGRAM MRNA TO PRE-VACCINATE US AGAINST 50 MOST COMMON MUTATIONS TA DRIVE CANCER, THIS GIVES OUR BODIES A CHANCE TO TARGET AND ELIMINATE BEFORE THEY CAN CREATE A TUMOR, WHAT IF WE COULD DEVELOP DRUGS THAT HAVE PRECISE MOLECULAR ZIP CODES THAT WOULD ALLOW FOR UNPRECEDENTED TARGETING ACROSS THE BLOOD BRAIN BARRIER TO SPECIFIC CELLS IN OUR BODY, WITHOUT ANY UNTOWARD SIDE EFFECTS AND THESE ARE JUST COUPLE OF EXAMPLES AND THERE ARE OTHERS ON THE SLIDE AS WELL OF THE POTENTIAL CAPABILITIES AND PLATFORMS THAT COULD BE POSSIBLE IF WE COULD HARNESS THE BEST IDEAS AT THE RIGHT TIME WITH THE RIGHT AMOUNT OF RESOURCES. I'M SURE Y'ALL HAVE BETTER IDEAS YOU ARE HIKING AS YOU LOOK AT THIS SLIDE. I THINK THAT FOR ME WHAT THAT SIGNAL IS POTENTIAL FOR OPPORTUNITIES HERE THAT WE HAVE WITH ARPA H IS EVEN MORE EXCITING AND REALLY TREMENDOUS. SO WE MOVE TO THE NEXT SLIDE. I JUST WANT TO QUICKLY GO OVER WHAT POTENTIAL VERSION OF THE MISSION COULD READ BECAUSE OF COURSE AT MOMENT ARPA H IS STILL JUST A PROPOSAL. BUT WHAT WE HAVE HERE IS THAT AID COULD BENEFIT THE HEALTH OF ALL AMERICANS BY UTILIZING HEALTH BREAK THROUGHS NOT READILY ACCOMPLISHED THROUGH TRADITIONAL RESEARCH OR COMMERCIAL ACTIVITY. TO ME THE LAST POINT IS REALLY KEY BECAUSE WHAT WE ARE TALKING ABOUT IS DOING THINGS THAT CAN'T BE DONE CURRENTLY, THAT ARE REALLY INCREDIBLY DIFFICULT TO DO. THAT IS THE SPACE THAT ARPA H WANTS TO LIVE IN. ADVANCING THIS MISSION AND THE IDEAS MENTIONED PREVIOUSLY, IS GOING TO REQUIRE A NOVEL APPROACH TO MORE SUPPORTING BROAD BIOMEDICAL RESEARCH. AND THE IDEA WITH ARPA H IS TO LEVERAGE -- >> WE HAVE LOST YOUR AUDIO. HOPEFULLY YOU CAN STILL HEAR US? >> I CAN. >> I HEAR TARA JUST FINE. HAVE OTHERS? >> SAME HERE. >> I'M HEARING HER FINE AS WELL. >> WE CAN HEAR HER. >> OKAY. GOOD. I WAS WORRIED FOR A SECOND. I HAVE OTHER DEVICES TO SWITCH TO IF NEEDED. HOPEFULLY AUDIO GETS CORRECTED ON YOUR END AND OTHERS CAN STILL HEAR ME. TO GO BACK TO THIS APPROACH, THAT ARPA H IS GOING TO TAKE, LEVERAGING WHAT WAS PIONEERED AT DARPA, IT'S UTILIZED THERE FOR 60 PLUS YEARS, AND HAS ALSO BEEN APPLIED IN OTHER AREAS OF R&D MORE RECENTLY. IF YOU THINK ABOUT ARPA E, AND EVEN BRTA, AND WE REALLY WANT TO EMBRACE THIS APPROACH FOR BIOMEDICAL AND HEALTH RESEARCH. WE PROPOSE TO CREATE THIS DISTINCT ENTITY WITHIN NIH THAT'S HAVE AUTONOMY AND INDEPENDENCE RESOURCES AND AUTHORITIES TO TACKLE SOME OF THESE BIG CHALLENGES FACING HUMAN HEALTH. IN THE NEXT SLIDE WE TALK ABOUT THIS ARPA MODEL. FOR ANYONE WHO MAY BE LESS FAMILIAR JUST AGAIN TO LEVEL A LITTLE, THE MODEL EMBRACES A PROGRAM MANAGER CENTRIC MENTALITY, IT PROMOTES ACTIVE PROJECT MANAGEMENT AND ACCOUNTABILITY THROUGH QUANTIFIABLE METRICS AN STAGE GATING. IT APPROACH THE ORGANIZATION THROUGH A LENS OF BEING LEAN AND MINIMUMMABLE BUT BUILDS IN A FAIR AMOUNT OF AUTONOMY AND ACCOUNTABILITY. IT FOCUSES ON MISSION DRIVEN RATHER THAN REQUIREMENT OR CAST DRIVEN -- TASK DRIVEN RESEARCH. MENT THAT WHICH IS BOLD AND RISKY BUT COULD OFFER REALLY HIGH RETURN. T THAT ADHERES TO URGENT TIME BOUND PRINCIPLES THAT ARE APPLIED NOT JUST TO THE PROGRAM -- BUT ALSO TO THE STAFF TENURE. IN REFERENCE TO SORT OF THIS HIGH RISK HIGH REWARD APPROACH I LIKE TO GIVE THE ANALOGY THAT WHAT WE WANT TO DO WITH ARPA H IS ON SOME LEVEL, HITTING -- IT IS LIKE THROWING A DART IN A DARK ROOM. IF YOU HIT A DARK DART BOARD, ON THE BULLS EYE IT IS AMAZING. AND IF YOU DON'T YOU LEARN THAT IT IS NOT IN THAT LOCATION AND NOW YOU CAN AIM SOMEWHERE ELSE. BUT OBVIOUSLY BUILDING OFF AND LEARNING FROM WHAT YOU ARE DOING BUT HAVING THE POTENTIAL TO HAVE A REALLY HIGH IMPACT SO IF WE MOVE TO THE NEXT SLIDE. TO ENUMERATE THE GOALS OF ARPA H, POTENTIAL GOALS OF ARPA H. THEY ARE HERE SUPPORTING TRANSFORMATIVE HIGH RISK HIGH REWARD RESEARCH OF COURSE BUT DOING SO BY EMBRACING A SENSE OF URGENCY AND SPEEDING THE APPLICATION IMPLEMENTATION OF BREAK THROUGHS AT VARIETY OF DIFFERENT LEVELS. SO WE SAY FROM THE MOLECULAR TO THE SOCIETAL. AND RECOGNIZING THAT IS PRETTY BROAD BUT DOING SO IN A WAY THEY SERVE ALL PEOPLE. TO BUILD CAPABILITIES AND PLATFORMS THAT ARE BROADLY APPLICABLE ACROSS A WIDE RANGE OF DISEASE AND CONDITIONS. TO REVOLUTIONIZE HOW WE PREVENT DETECT TREAT CURE THEM. WE WANT TO FOCUS ON CONVERTING USE DRIVEN IDEAS SO THOSE IDEAS WITH DIRECT APPLICATION INTO THE SOLUTION FOR PATIENTS REALLY QUICKLY. AND THEN HELP OVERCOME MARKET FAILURES THROUGH CREATIVE SOLUTIONS AND DERISKING. THERE ARE AREAS RIPE FOR TRANSFORMATION IF STIMULATED THEM THROUGH THE RIGHT SUPPORT AND COLLABORATION. IF WE MOVE TO THE NEXT SLIDE. THE GUIDING PRINCIPLES THAT DRIVE ARPA H ECHO ELEMENTS OF THE ARPA MODEL. ARPA H IS CENTERED AROUND AND SHOWING THIS RISK TOLERANCE OR RISK ACCEPTANCE, AND INSTILLING KEY FOUNDATIONAL VALUES THAT ARE INHERENT IN THE ARPA MODEL. BUT IN ORDER TO DO THAT WE RECOGNIZE CULTURE IS KEY TO ARPA H SUCCESS. THAT IS SOMETHING NCATS WORKED HARD TO BUILD AND DEVELOP OVER ITS TEN PLUS YEARS NOW HISTORY. AND THINKING ABOUT WHERE ARPA H SHOULD LIVE, THE ADMINISTRATION SUPPORTS ARPA H, HE PROPOSES A COME PENT OF NIH. AND LINKED TO NIH REALLY DRAW ON THE VAST KNOWLEDGE EXPERTISE AND INFRASTRUCTURE THAT CURRENTLY EXISTS HERE AT NIH. INCLUDING INSTITUTES LIKE NCATS AND THINKING CONNECTIONS AND COLLABORATIONS AND SYNERGIES THAT WE CAN BUILD THERE. BUT RECOGNIZING THAT IT DOES NEED TO BE DISTINCT AND HAVE ITS OWN CULTURE AND ORGANIZATION AUTONOMY. IN DOING SO ARPA H IS GOING TO SEEK THE BRING ON THE MOST INNOVATIVE PEOPLE WITH THE MOST NOVEL IDEAS THAT WILL FORM ROBUSTLY DIVERSE AND COLLABORATIVE TEAM. AND EQUITY IS GOING TO BE ESSENTIAL AND GOING TO BE CONSIDERED ESSENTIAL ELEMENT OF ARPA H AND KEY IN ITS INTERNAL PRACTICES LIKE HIRING AND IN THE PROJECTS AND PROGRAMS IT SUPPORTS, I LOOK AT THIS IN SORT OF THREE WAYS. RIGHT? THINKING ABOUT ROBUST EQUITY IN THE PEOPLE THAT HIRE, THE PROGRAMS THAT SUPPORT, AND THE PERFORMERS IT MAKES AWARDS TO. CONTINUING WHICH IS DOES AROUND PEOPLE, THE DIRECTOR OF ARPA H AS WELL AS PROGRAM MANAGERS ARE INTENDED TO BE TERM LIMITED AND NOT A 20 YEAR TERM, MUCH SHORTER TERMS. THINKING IN THE LIKE THREE TO FIVE YEAR RANGE. THIS FIRST DIRECTOR, THEY ARE GOING TO SET THE STAGE FOR SO MANY YEARS TO COME AND IT IS GOING TO BE REALLY CRITICAL FOR US TO FIND THE RIGHT LEADER, THAT'S GOING TO EXCEL TECHNICALLY AND AS A LEADER. IT WILL ALSO BE A REALLY FLAT DYNAMIC ORGANIZATION BUILT NIMBLE AND OPERATIONALIZING SCIENTIFIC PORTFOLIO. AND BUSINESS PROCESSES. AGAIN WE TALK ABOUT THAT SENSE OF URGENCY AND OPERATING UNDER TIME BOUND PRINCIPLES. WHAT WE MEAN BY THAT IN ADDITION TO TERM LIMITS WHAT I ALWAYS HEAR WHAT I HAVE HEARD MANY, MANY TIMES FROM THE DRPA FOLKS I HAVE SPOKEN WITH IS WHEN THEY COME ON BOARD, THEY GET THEIR BADGE AND THEIR BADGE HAS AN EXPIRATION DATE ON IT AND THAT'S THEIR TICKING TIME CLOCK. THEY LOOK AT THAT EVERY DAY WHEN THEY PLUG TO COMPUTER OR WHEN WE WERE GOING BACK TO THE OFFICE AND THEY SCANNED IT TO GET IN THE BUILDING OR THROUGH THE GATE OR WHATEVER. IT WAS A CONSTANT REMINDER OF WHAT THEY WANTED TO ACHIEVE OVER THAT TIME PERIOD. I THINK THAT THAT IS JUST A REALLY NICE MANIFESTATION OF LIKE THAT CULTURAL ASPECT. I WILL ALSO MENTION IN TERMS OF THINKING THROUGH TIME BOUND PRINCIPLES. IT IS GOING TO BE GOING TO OPERATE WITH UTILIZING DIFFERENT PROCESSES. FROM THE REST OF NIH, IT LIKELY WILL NOT BE ISSUING GRANTS BUT MORE TAKE AGO APPROPRIATE OF CONTRACTS AILINGOR AND TRANSACTION AND CHALLENGES, THINGS YOU ARE FAMILIAR WITH BUT WANTED TO MENTION THAT. WITHOUT DWELL ON THIS SLIDE TOO MUCH LONGER, I JUST WANT TO REITERATE THE IMPORTANCE OF OPEN AND TRANSPARENT. ABOUT PROsS AND APPROACHES AS IT DEVELOPS THEM. AND IMPORTANTLY, ENGAGING STAKEHOLDERS ACROSS A WIDE RANGE OF SECTORS AND DISCIPLINES EARLY AND OFTEN. IF WE ARE DEVELOPING THIS AS WE TALK ABOUT IT WITH A FOCUS ON USE DRIVEN RESEARCH, WE WANT TO BE COGNIZANT ABOUT THE FACT THAT THOSE END USERS SHOULD BE INVOLVED AND AT THE TABLE FROM THE BEGINNING STAGES OF DEVELOPING A PROGRAM. AND CONSULTING THROUGH THE PROCESS. AND TO MISQUOTE I GUESS, THE -- I GUESS OFTEN USED FIELD OF DREAMS ANALOGY, IF YOU BUILD IT THEY WILL COME, WHAT WE DON'T WANT TO DO IS BUILD IT, HAVE THEM COME AND THEN WHY ON EARTH DID YOU BUILD A BASEBALL PEELED IN THE MIDDLE OF A CORN FIELD? AND SOMETIMES THAT WORKS AND IT IS AMAZING BUT OTHER TIMES I ASK WHY DIDN'T YOU BUILD A SOCCER FIELD, THAT'S WHAT WE WOULD HAVE WANTED. SOMETHING COMPLETELY DIFFERENT. NOT EVEN A FIELD TO PLAY A SUPPORT ON SO JUST RECOGNIZING THE IMPORTANCE OF THAT REALLY EARLY AND FREQUENT ENGAGEMENT. AND PROMOTING INDEPENDENCE AND ACCOUNTABILITY THAT REINFORCED THROUGH AMBITIOUS MILESTONES AND METRICS. THIS WILL BE DRIVEN THROUGH THE PROGRAM MANAGERS PRIMARILY. WHO WILL HAVE BROAD AUTONOMY AND AUTHORITY TO BE CREATIVE AND DRIVE INVASION AND TRACK METRICS AND MAKE DECISIONS ABOUT FUTURES OF THE PROGRAM BASED ON THOSE METRICS. THEN OF COURSE FOLLOWING A FAIL FORWARD APPROACH AND EMBRACING THE ETHOS OF IF YOU ARE GOING TO FAIL, FAIL EARLY AND ACCEPTING FAILURE AS A NORMAL EXPECTED COMPONENT OF ITS OPERATIONS SO ESSENTIALLY WHAT THIS MEANS IS YOU ARE FAILING IF YOU ARE NOT AT LEAST FAILING OCCASIONALLY. IF WE CAN MOVE TO NEXT SLIDE. I WILL CALL OUT OUT AUTHORITIES NEEDED TO DO THIS BECAUSE THIS IS REALLY KEY AND CRITICAL TO SUCCESS. MOSTLY A LOT OF THEM ANYWAY ARE AROUND ABILITY TO HIRE AND RECRUIT THE BEST PEOPLE. AND HAVING FLEXIBLE FUNDING AUTHORITIES THAT ALLOW FOR USE OF MULTIPLE APPROACH TO DISTRIBUTE RESOURCES. AND TO DO SO OVER MULTIPLE YEARS. SO AGAIN THIS WOULD BE THINGS LIKE OTHER TRANSACTION AND PRIZE AUTHORITIES AND MULTI-YEAR APPROPRIATIONS. THE PEER REVIEW PROCESS ARE ROBUST AND EXPERT DRIVEN BUT DIFFERENT THAN TRADITIONAL NIH PEER REVIEW PROCESS AND AUTHORITIES WOULD BE IMMEDIATED TO ENSURE THIS IS POSSIBLE FOR ALL MECHANISMS ESPECIALLY IF PLACED WITHIN NIH INFRASTRUCTURE. THERE ARE OBVIOUSLY A FEW OTHER THINGS LIKE EXEMPTING CERTAIN INFORMATION FROM FOIA, RELATED TO COMPANIES BUSINESS AND COMMERCIALIZATION INVESTMENT PLANS AND COLLABORATING WITH AND POTENTIALLY REIMBURSING FDA FOR CERTAIN ACTIVITIES. AND THIS WOULD BE A WAY TO FACILITATE THAT INTERACTION IN A MUCH MORE ROBUST AND DEFINED WAY. IF WE MOVE TO THE NEXT SLIDE. WE ARE ASKED QUITE A BIT ABOUT WHERE IDEAS WILL COME FROM. SO HERE JUST TRY TO ILLUSTRATE THAT IDEAS ARE GOING TO COME FROM AND FORMED BY MANY DIFFERENT SOURCES. PATIENTS ADVOCATES, ACADEMIA, INDUSTRY AS WELL AS OTHER SCIENTIFIC SAKE HOLDERS LIKE FROM ACROSS THE FEDERAL GOVERNMENT AND IDEAS GENERATED AND REFINED BY CONSIDERING THE DIVERSE ARRAY OF PERSPECTIVES, BRINGING IN PEOPLE WITH DIFFERENT BACKGROUNDS AND EXPERTISE. DIFFERENT STAKEHOLDERS, DIFFERENT SCIENTIFIC DISCIPLINES, DIFFERENT PARTNERSHIPS AND MORE. THE ARPA H DIRECTOR HAS AUTONOMY TO STEP PRIORITIES AND PROVIDE PROGRAM MANAGER WHOSE WILL COME BEARING IDEAS WITH THE INDEPENDENCE TO ENACT THAT VISION. WITH ROBUST SUPPORT BUT OFTEN MINIMAL INVOLVEMENT FROM THE DIRECTOR. ESSENTIALLY WHAT THAT MEANS IS HIRE REALLY GOOD SMART PEOPLE AND GIVE THEM THE FREEDOM TO DO WHAT THEY DO BEST. THAT'S WHAT ARPA H PROGRAM MANAGERS WILL BE DOING, THEY WILL BE RESPONSIBLE FOR TAKING IN FEEDBACK FROM ALL THESE DIFFERENT SOURCES, THAT THEY ARE RECEIVING. AND DRAFTING OLD PROGRAMS NEXT SLIDE WE DON'T HAVE THE GOOD IDEAS AND KNOW CHALLENGES AND ISSUES FACING THE COMMUNITY WE HAVE BEEN TRYING TO FIRST FOREMOST SHARE INFORMATION ABOUT ARPA H AS AVAILABLE ALSO MORE IMPORTANTLY TO HEAR FROM THE COMMUNITY. TO DATE NIH AND OSTP HELD AN INFORMATION SESSION AVAILABLE ONLINE, PUBLISHED COMMENTARY IN SCIENCE AND HAS HELD NUMEROUS MEETINGS WITH DIFFERENT ORGANIZATIONS, VARIETY OF DIFFERENT PRESENTATIONS, SUCH AS THIS. WE ALSO UNDERTOOK A SERIES OF LISTENING SESSIONS. TO HEAR FROM DIFFERENT VOICES ACROSS THE COMMUNITY. GO TO NEXT SLIDE SUMMARIZE THOSE LISTENING SESSIONS WHICH WERE LED BY LEADERSHIP FROM ACROSS THE OSPTP AND NIH INCLUDE ALL 27 INSTITUTE AND CENTER DIRECTORS AND JONI PARTICIPATED IN ONE OF THOSE. OVER THE COURSE OF WE HAD 15 SESSIONS AND THEN ONE FEEDBACK SESSION, 16. WE HEARD FROM OVER 5100 STAKEHOLDERS INCLUDING NEARLY 250 ORGANIZATIONS FROM ALL OVER THE COUNTRY. I HOPE MANY OF YOU ARE ABLE TO PARTICIPATE IN THOSE. WHAT CAME OUT OF THAT IS SEVERAL THEMES THAT WE HAVE GROUPED INTO TWO MAIN BUCKETS. COMMENTS ON THE NATURE OF SCIENTIFIC PORTFOLIO AND THE KEY ASPECT ON WHICH TO FOCUS AS WELL AS THE ADOPTION OF STREAMLINE YET NIMBLE PROCESSES FOR FLEXIBILITY AND BROAD INCLUSION. I FOR GOT TO SAY -- HERE IS AN ANIMATION HERE BUT IF WE CAN MOVE FORWARD TWO NOW. THAT WOULD BE GOOD BECAUSE I WILL TALK ABOUT THAT A LITTLE BIT FURTHER. SO IF WE MOVE TO THE NEXT SLIDE. THE AREAS OF FOCUS ON THE PORTFOLIO IN TERMS OF FEEDBACK WE RECEIVE REALLY CENTERED AROUND THE NEED TO COMPLIMENT NIH RESEARCH PORTFOLIO AND NOT DUPLICATE IT AND OF COURSE THAT SOMETHING THAT WE OBVIOUSLY ARE VERY KEENLY AWARE OF AND WANT TO TAKE STEPS TO AVOID. AND REALLY TO ALSO NOT JUST AVOID DUPLICATION BUT IDENTIFY AREAS FOR COLLABORATION AND SYNERGY TO ENHANCE EFFORTS ACROSS BOTH ORGANIZATIONS WHETHER ARPA H OR NIH INSTITUTES AND CENTERS. WE ALSO HEARD ROBUSTLY ABOUT THE IMPORTANCE AND CRITICALITY OF ADDRESSING HEALTH INEQUITIES. AND PROMOTING HEALTH EQUITY AND THIS IS IMPORTANT TO THE ADMINISTRATION BROADLY AND SOMETHING WE IN THINKING ABOUT SETTING UP A NEW ORGANIZATION WE WANT TO BUILD IN TO IT FROM ITS FOUNDATION. WE HEARD A DESIRE TO HAVE -- TO BUILD TECHNOLOGIES, PLATFORMS THAT ARE REALLY BROADLY APPLICABLE THAT ARE NOT DISEASE SPECIFIC. ALSO WE HEARD BROADLY ABOUT EVERY SINGLE COMMENT YOU CAN IMAGINE ABOUT DATA SO THINKING ABOUT ACCESSIBILITY INTEGRATION SHARING STANDARDS TOOLS, ET CETERA. HOW TO LEVERAGE AI IN CREATIVE AND UNIQUE WAYS. AND FOCUS ON COMMERCIALIZATION AND PUSHING PRODUCT CLOSER TO MARK TO GET TO PATIENTS. WE HEARD ABOUT PROCESSES. AND THE MAIN TAKE HOME HERE IS THE NEED THE STREAMLINE PROCESSES TO EXPEDITE DISCOVERY THROUGH INTEGRATION OF THE COMMUNITY PATIENTS AND THEIR PROVIDERS EARLY IN THE PROCESS AS MENTIONED BEFORE. BUT BUILDING MULTI-DISCIPLINARY COLLABORATION AND PARTNERSHIPS, SO DRAWING IN SCIENTISTS FROM OTHER DISCIPLINES, HOW WE CAN PULL IN FOLKS FROM CHEMISTRY OR MATH OR PHYSICS. ENGINEERING. I KNOW THIS IS SOMETHING THAT THERE IS A PUSH FOR THIS ACROSS SCIENCE, THAT WAS EMPHASIZED WE SHOULD FOCUS ON WITH ARPA H AND WORKING WITH INDUSTRY NON-PROFITS AND OTHERS IN THE PRIVATE SECTOR. SO GO TO NEXT SLIDE. BACK IN SEPTEMBER WE RELEASED A REPORT SUMMARIZING THE FEEDBACK, THAT IS AVAILABLE ON LINE, ON THE OSTP AND I BELIEVE ALSO POSTED ON THE HIPPOWEBSITE. AS I MENTIONED -- NIH WEBSITE. WE HELD A FOLLOW-UP LISTENING AND FEEDBACK SESSION TO ENSURE THAT WHAT WE HEARD INDICATED TO US WE CAPTURED IN OUR ELEMENTS AND THAT WE WERE HEARING FOLKS CORRECTLY. WE ALSO HOOKED TOGETHER ADDITIONAL FEEDBACK HOW TO ENGAGE WITH THE COMMUNITY. IF YOU MOVE TO THE NEXT SLIDE. JUST SORT OF UPDATE I GUESS OR REMINDER MAYBE WHERE THINGS STAND. THE PRESIDENT IN HIS FY 22 BUDGET REQUEST INCLUDED $6.5 BILLION FOR ARPA H, NOW THE HOUSE INCLUDED ARPA H IN THEIR DRAFT FY 22 APPROPRIATIONS BILL AND PUT FORTH 3 BILLION IN APPROPRIATIONS. WE SAW SIMILAR LANGUAGE ON THE SENATE SIDE WITH BUDGET OF 2.4 BILLION SO OF COURSE THE FY 22 APPROPRIATION HASN'T OFFICIALLY MOVED FORWARD OR PASSED YET SO WE ARE KIND OF IN A WAITING STATUS THERE TO SEE HOW THIS ALL PLAYS OUT AND WHERE IT ENDS UP GETTING FINALIZED IN THE MIDDLE. IF YOU MOVE TO NEXT SLIDE IN TERMS OF OUR AUTHORIZATION, THERE ARE COUPLE OF OPTIONS FOR AUTHORIZATION THAT HAVE BEEN INTRODUCED. THERE WAS A BILL REPRESENTATIVE ESCHEW RELEASED IN OCTOBER AND THE CARES 2.0 BILL THAT REPRESENTATIVES UPTON INTRODUCED IN OCTOBER AND WE HOPE TO SEE MOVEMENT SOON. ONE THING I WILL SAY IS IN ADDITION TO PRESIDENTIAL SUPPORT THIS INITIATIVE HAS, WE'VE HEARD GREAT BIPARTISAN CONGRESSIONAL SUPPORT AND SO OPTIMISTIC ABOUT IT, ITS SUCCESS FOR HOPEFULLY FY 22 BUT FOR THE FUTURE. SO YOU GO TO THE FINAL SLIDE I BELIEVE. THE TAKE HOME HERE IS THAT WE KNOW THIS ARPA MODEL WORKS. AND WE HAVE SEEN HOW SUCCESSFUL DARPA HAS BEEN. THERE ARE SO MANY AREAS RIPE FOR TRANSFORMATION. WE JUST NEED TO HARNESS AND FOSTER THEM SO THAT WE CAN TAKE THESE POTENTIAL OPPORTUNITIES TO SHAPE THE FUTURE OF HEALTH AND MEDICINE AND SIGNIFICANTLY IMPROVE QUALITY OF LIFE FOR ALL AMERICANS BY LEVERAGING THIS MODEL WE KNOW WORKS. SO WITH THAT JONI, I DON'T KNOW I THINK WE STILL HAVE A FEW MINUTES OR QUESTIONS OR COMMENTS? >> THANK YOU SO MUCH. REALLY APPRECIATE IT. WE DO HAVE A FEW MINUTES FOR QUESTIONS. PAUL I SEE YOUR HAND FIRST PLEASE GO AHEAD. >> TARA GREAT JOB. THANK YOU FOR THAT PRESENTATION. WHERE DO YOU SEE OR WHERE DO THE GROUP THINKING ABOUT THIS MOST SEE THE IC RECORDS SITTING HERE? I'M THINKING ONE LEVEL DOWN MAKING SURE WE DON'T HAVE THAT DUPLICATION OF EFFORT AND FOCUSING ON THE RIGHT PROBLEMS. >> OVER THE SUMMER AND INTO FALL, THE NIH LEADERSHIP CONVENED A GROUP OF IC DIRECTORS THINK THROUGH HOW HAY WORK TOGETHER AND I CAN'T RECALL JONI IF YOU WERE ON THAT GROUP. >> YES. >> I KNOW I SPOKE AT THEM ONCE OR TWICE. THEY PROVIDED SOME REALLY GREAT FEEDBACK IN THINKING THROUGH HOW WE CAN COORDINATE, HOW WE COULD ENSURE THAT THERE WAS AN EXCHANGE OF IDEAS AND EXCHANGE OF INFORMATION ACROSS THEM. GOING FORWARD THERE'S A COUPLE OF AREAS WE CAN ENOR ENVISION COLLABORATION BETWEEN ARPA H AND ICs AND THAT'S FIRST AND FOREMOST REVIEW PROCESS WILL BE MOSTLY HEARD OF FEDERAL DRIVEN PROCESS AND WE'LL NEED EXPERT REVIEWERS TO REVIEW SOME OF THE ARPA H APPLICATIONS. SO THAT TO ME IS A GREAT WAY TO HAVE INVOLVEMENT AND TO LEVERAGE EXPERTISE OF DIFFERENT ICs. WE ALSO KNOW THERE'S GOING TO BE SOURCES OF IDEAS AND SO SHOULD -- GOING TO TRY TO THINK THROUGH A FEEDBACK LOOP IF YOU WILL FOR DEVELOPMENT OF THOSE IDEAS AND WHAT EXACTLY THAT MEANS AND LOOK LIKE. AND I THINK WITH ARPA H ESPECIALLY AS THIS IS GETTING DEVELOPED, THIS IS NOT LIMITED TO THE OTHER NIH ICs BUT BROADER ACROSS THE FEDERAL GOVERNMENT, WE WANT TO MAKE SURE THAT PEOPLE ARE AWARE OF AND SUPPORTIVE OF ARPA H AND WHAT IT IS DOING AND TRYING TO THINK THROUGH REALLY ROBUST WAYS TO FACILITATE STAFF INTERACTION AND EVEN DETAILS AND OTHER WORK KIND OF EXCHANGE OPPORTUNITIES AS WE CONTINUE TO BUILD UP THIS EFFORT AND WE DISCUSSED THESE ALSO ON THE INTERAGENCY LEVEL TOO BECAUSE WE HAVE INTERAGENCY COMMITTEE. >> THANKS. RAJESH YOU HAD YOUR HAND UP. >> AS SOMEONE WHO SORT OF WORKED INDUSTRY CAME TO NIH THEN LEFT NIH GO BACK TO ACADEMIA AND INDUSTRY, I WOULD RAISE A COUPLE OF THINGS THAT I -- YOU MIGHT HAVE HEARD ME TALK ABOUT. THIS MODEL OF ESSENTIALLY HIRING WORK FORCE THAT IS TERM LIMITED IS RUNS COUNTER TO THE COMPENSATION SCHEME AVAILABLE IN THE GOVERNMENT. SO IF YOU ARE PLANNING TO HIRE THE BIGGEST BEST AND BRIGHTEST INCLUDING THE DIRECTOR OF ARPA H, YOU CAN PAY A PERSON THESE PRESIDENT SALARY, NOT SURE YOU ARE GOING TO GET A LIST CHARACTERS. SO I'M VERY SKEPTICAL ABOUT THAT PARTICULAR PIECE OF HOW YOU WILL STRUCTURE AND IF IT WILL SIT WITHIN THE NIH. THE OTHER PART I GUESS LINKED TO THE IC QUESTION, WILL THIS BE AN IC, WILL THIS BE SAME SANDING OF IC, WILL IT BE OFFICE? WHAT IS IT STRUCTURE? I WAS INVOLVED IN THE STANDING UP OF NCATS, THERE IS A 19 WHATEVER -- 79 OR 89 LAW, 26 INSTITUTES AT NIH. SO IF ONE NEEDS TO CREATE A NEW ONE, ONE NEEDS TO DISAPPEAR. LAST TIME IT WAS NCRR TO CREATE NCATS. SO THAT'S BEGS THE QUESTION TO WHAT LEVEL THIS IS BEING SET UP. LINKED TO THAT QUESTION IS NCATS COUNCIL MEMBER, I GUESS I WOULD JUST RAISE THE PRESENTATION AND VALUES YOU ESPOUSED AND ETHOS YOU WANT THERE, THESE ARE THINGS THAT WE ARE SEEING IN PRACTICE BEING PUT MANY PLAY BY THE NCATS STAFF. SO HOW SHALL I PUT IT, A VOLKSWAGEN AND AUDI ARE ON THE SAME CHASSI. SO IS CAMRY AND INFINITY. SO IF THERE IS A REQUIREMENT FOR REBRANDING THAT WOULD MAKE A DIFFERENCE OKAY WE CAN SEPTEMBER THAT BUT YOU GOT A FRAMEWORK -- ACCEPT THAT, BUT YOU HAVE A FRAMEWORK OF SOMETHING WHY NOT USE WHAT YOU HAVE TO BUILD WHAT YOU NEED TO DO RATHER THAN COMPLETELY REINVENT SOMETHING NEW. I WORRY A LITTLE BIT ABOUT THE NIH SYNDROME, CALL IT NOT INVENTED HERE SYNDROME IN PLAY HERE. SO I'M RAISING -- BEING GLASS HALF EMPTY HERE BUT ON BEHALF OF N CATS I'M CONCERNED HOW ARPA H SETS ITSELF UP FOR SUCCESS, THE GOAL IS LAUDABLE BUT THE -- IN AN OPERATIONAL WAY TO GET THE RIGHT PEOPLE YOU GOT TO PAY THEM THE RIGHT AMOUNT TO GIVE THEM THE AUTONOMY BUT IN THE STRUCTURE OF THE NIH HOW ARE YOU GOING TO MAKE THAT HAPPEN? >> I THINK A LOT OF IT TIES BACK TO THE SHORT ANSWER FOR ALL THREE OF THOSE QUESTIONS, REALLY TIES BACK TO AUTHORITIES THAT ARE NEEDED. THESE ARE THINGS WE HAVE BEEN WORKING VERY CLOSELY WITH THE HILL ON IN GIVING TECHNICAL ASSISTANCE WHERE NEEDED. TO PROVIDE RATIONALE FOR WHY WE DO THINK THAT IT IS IMPORTANT FOR ARPA H TO HAVE FOR EXAMPLE REALLY ROBUST FLEXIBLE HIRING AUTHORITIES. BECAUSE AS YOU INDICATED, THERE ARE LIMITATIONS THERE. WE HOPE SOME LEVEL ONE OF THE THINGS THAT WE WILL ARACKET FOLKS TO IS THE ABILITY ESPECIALLY WITH FIRST INSTRUCTOR TO SHAPE AND MOLD THIS ORGANIZATION BUT ALSO THE POTENTIAL OPPORTUNITIES THAT EXIST SO WE ARE GOING TO BE CONFINED BY CERTAIN RESTRICTIONS, OPERATING WITHIN THE FEDERAL GOVERNMENT BUT HAVING AS FLEXIBLE OF AUTHORITY AS POSSIBLE WILL BE REALLY HELPFUL. SO HA IS THE FIRST POINT. THE SECOND QUESTION, I'M FAILING THIS COGNITIVE TEST, WAS AROUND REALLY -- REMIND ME. >> ABOUT THE ICs, WHERE WILL IT STAND, IS THE STRUCTURE. >> YEAH. SO THE STRUCTURAL ORGANIZATION THAT BEING CONSIDERED RIGHT NOW, IT WILL HINGE ON THE LANGUAGE IN THE FINAL BILLS FOR THIS BECAUSE AGAIN THIS IS STILL PROPOSAL PHASE, DOESN'T EXIST, IN DRAFT FORM. T IT IS BEING PROPOSED AS NOT CALLING AN INSTITUTE, IT WON'T BE LOCATED WITHIN THE OD. I LIKE TO REFER TO IT AS ARPA H BECAUSE IT IS UNIQUE. IT IS DIFFERENT BUT IT WOULD BE AT SIMILAR LEVEL AS AN IC. I DON'T THINK WE HAVE TO WORRY AT ALL KIND OF THE ISSUE OF RESTRUCTURING NIH TO ACCOUNT FOR THAT CAP, THAT IS SOMETHING THAT WILL BE ADDRESSED AS NEEDED WITHIN THE AUTHORIZING LANGUAGE AND TO YOUR LAST POINT ABOUT THE SYNERGIES AND COMMONALITIES OF ARPA H COUPLE OF THINGS TO POINT OUT, ARPA H DOES NOT INTEND TO HAVE AN INTRAMURAL PROGRAM, SO ONE THING THAT WILL MAKE IT SOMEWHAT DISTINCT. AMONG THE INSTITUTES AND CENTERS. BUT ALSO WHAT WE ARE TALKING ABOUT HERE TOO IS LEVERAGING DIFFERENT APPROACH AND MIND SET TO FUNDING BIOMEDICAL RESEARCH, THAT DRPA OR ARPA MODEL IF YOU WILL AND WHILE I DO THINK THERE ARE ELEMENTS THAT I THINK RING TRUE AND PROBABLY SOUND SOMEWHAT FAMILIAR FROM AN NCATS SIDE THERE ARE DISTINCT DIFFERENCES AND IT IS SOMETHING JONI AND I TALK ABOUT HOW TO ENSURE THE DISTINCTION AND THE COORDINATION BETWEEN NCATS AND ARPA H THERE AND AGAIN WE WANT THIS TO BE COMPLIMENTARY SO WE ARE BUILDING OFF THE DIFFERENT EFFORTS THAT NOT JUST NCATS BUT ALL THE ICs. >> MAY I ASK A FOLLOW UP QUESTION? >> KELLY WILL HAVE THE LAST WORD. GO AHEAD. >> I GUESS IF I HAIR YOU TALKING ABOUT THAT HOW NCATS, MAYBE I'M JUST TOO USED TO THINKING STRUCTURE AND HOW THEY WORK. JUST AS BARTA COULD BE PART OF NIH BUT IT ISN'T. GIVEN WHAT IT DOES. IF YOU ARE GOING TO DO THIS WHY NOT SET IT UP UNDER HHS AS ANOTHER AGENCY EQUAL TO NIH RATHERTHER HAHN SUBSUMING NIH, NOT SURE WHAT -- YOU WANT A DIFFERENT CULTURE, YOU WANT SOMETHING DIFFERENT PRESUMABLY NOT GOING TO PUT ON THE THE SAME CAMPUS SAME BUILDINGS, SUFFICIENTLY DIFFERENTLY SO WHY SHORN IT? >> SHOE HORN IT? >> THREE REASONS, IT FITS WELL WITH NIH. THE MISSION OF ARPA H FITS WELL AND SQUARELY WITHIN THE MISSION OF NIH. SO THAT'S ONE POINT. THE SECOND POINT I WOULD SAY IS TO LEVERAGE EXPERTISE AND KNOWLEDGE THAT WE HAVE AT NIH AND REALLY HELP TO FACILITATE COLLABORATION. THE FURTHER REMOVED YOU ARE, THE HARDER TO BUILD THOSE. WE HAVE SEEN INTERACTIONS WITH BARTA. TAKEN A LONG TIME TO GET TO WHERE WE CURRENTLY ARE. THE THIRD POINT IS MAYBE THE MOST PRACTICAL. THAT IS THAT WE -- STARTING THIS WITHIN AN EXISTING ORGANIZATION LIKE NIH ALLOW US TO LEVERAGE INFRASTRUCTURE THAT EXISTS AND WHAT I MEAN BY THAT, IS THE IT NETWORKS, AGREEMENTS AROUND GETTING SPACE AND REALLY JUST PRACTICAL THINGS THAT ALLOW US TO GET UP AND RUNNING IN A MUCH QUICKER TIME FRAME THAN IF WE HAD TO START COMPLETELY FROM SCRATCH AS A NEW ORGANIZATION WITHIN HHS. IT WOULD SET US BACK YEARS. >> I HAVE ONE OTHER QUESTION BUT WILL LET KELLY GO FIRST. >> WE COULD PROBABLY TALK ALL DAY. >> WE PROBABLY COULD. IN EX TIME WE'LL HAVE MORE TIME FOR YOU. >> THANK YOU, TARA, THAT IS A NICE PRESENTATION AND EVERYBODY LIKES TO HEAR THE IDEA OF MORE SPEED MORE URGENCY AND MORE IMPORTANTLY MORE BUDGET TO FOCUS ON BETTER HEALTH AND THE SIDE OF THIS THAT IS ALSO ABOUT GLOBAL COMPETITION FOR THE US. YOU JUST STARTED GOING DOWN A PATH AND I THOUGHT OH I CAN RETRACT MY QUESTION I DON'T NEED TO ASK BECAUSE YOU SAID THE PRACTICAL REASON IS REALLY ABOUT SHARED INFRASTRUCTURE. I WONDER WHAT REDUNDANCIES WILL BE MANAGED BY ARPA H WHEN YOU START TO THINK THE BREAK THROUGH INFRASTRUCTURE ALL THE WORDS THAT YOU USE TALKING ABOUT THE PLATFORM FOCUS PARTNERSHIPS AND COLLABORATIONS, I REALLY WAITING TO HEAR WHAT IS GOING TO BE REALLY DIFFERENT I FEEL LIKE NCATS DOES ALL OF THAT AND I THINK THE BREAK THROUGH INFRASTRUCTURE THEY HAVE IN PLACE AND I DON'T THINK THAT THAT IS A TERM USED ANYWHERE BUT THAT IS SORT OF WHAT HAS BEEN SET UP OVER THE PAST DECADE, WILL THAT BE LEVERAGED, THERE WILL BE RECONDITION DANCIES IF IT IS GOING TO NOT INCLUDE INTRAMURAL RESEARCH WILL EXTERNAL PEOPLE WORK AND COLLABORATE TO HAVE ACCESS TO SOME OF THESE RESOURCES THIS INFRASTRUCTURE THAT DOESN'T EXIST ANY PLACE ELSE IN THE WORLD EXCEPT BIG PHARMA. COULD YOU COMMENT ON THAT A LITTLE BIT? THAT GETS INTO SOME OF THE PRACTICAL BRASS TAX THAT HAS NOT BECOME CLEAR TO ME YET. >> I THINK EVERYTHING YOU JUST LAID OUT IS ABSOLUTELY CORRECT. THE LEVERAGING THE INFRASTRUCTURE THAT EXISTS HERE IS GOING TO BE A KEY ELEMENT OF ARPA H. I THINK THAT WE WOULD EXPAND THAT EVEN FURTHER TO TALK ABOUT SOME OF THE INFRASTRUCTURE THAT EXISTS ACROSS THE FEDERAL GOVERNMENT BECAUSE I THINK THERE IS A WHOLE LOT MORE WE COULD DO IN OPERATING IN SORT OF MUCH BETTER COORDINATION AS A WHOLE. EXACTLY WHAT YOU SAID, THE IDEA IS IS THAT WE WOULDN'T BE SETTING UP OUR OWN CLINICAL TRIAL NETWORKS OR OTHER THINGS THAT ALREADY EXIST WITHIN NIH BUT RATHER I VIEW IT AS A FEEDBACK LOOP. MAYBE EXAMPLE THIS IS NOT LIMITING BUT SOME OF THE REALLY INTERESTING AND EXCITING FUNDAMENTAL BASIC RESEARCH THAT'S COMING OUT OF THE INSTITUTES FEEDS INTO OR ALLOWS FOR THE IDEA ARPA H HAS TO MOVE FORWARD AND MAKE STRIDES AND ADVANCEMENTS AND THEN MAYBE YOU TAKE THAT AND GET THAT TO PROOF OF CONCEPT STAGE, AND YOU LEVERAGE AN ICs CLINICAL TRIAL NETWORK AND WORK WITH FDA AND CMS AND OTHERS ACROSS THE FEDERAL GOVERNMENT TO MOVE THAT FORWARD IN A ROBUST WAY. THERE MIGHT BE THEN AN OPPORTUNITY AT THE END TO OBVIOUSLY THEN HAVE ANOTHER MAYBE EVEN ARPA H PROJECT WHERE WHAT DOES THAT LOOK LIKE TO ADDRESS SOME MAYBE LARGE SCALE NATIONAL CHALLENGES TOWARDS IMPLEMENTATION. I THINK THE OTHER THING TO POINT OUT TOO IS THAT WITH ARPA H WHAT WE ARE TALKING ABOUT IS BIOMEDICAL AND HEALTH RESEARCH, WE USE THAT TERMINOLOGY REALLY BROADLY BECAUSE WE SORT OF VIEW IT FROM REALLY LARGE SPECTRUM OF THE TYPE OF RESEARCH THIS WILL SUPPORT AND GET INTO IMPLEMENTATION AND DISSEMINATION AND HOW THESE THINGS GET OUT TO PATIENTS. >> THANK YOU. >> LAST QUESTION OR IMMEDIATE TO CLOSE OUT? >> WE NEED TO CLOSE OUT. GO AHEAD, ASK YOUR QUESTION PLEASE. >> I WANT TO COME TO MONEY. SO YOU ARE MAKING THIS ASK IN THE BUDGET WHATEVER THE NUMBERS YOU SAID WHETHER IT IS WE HEARD DIFFERENT NUMBERS THROWN AROUND, 3 BILLION, 6 BILLION WHATEVER THAT MIGHT BE. HARKENING BACK TO EXPERIENCE STARTING N CATS AND WHAT WE GOT INITIALLY AND HOW WE GET IT TO THE POINT AND ONE OF THE THINGS THAT WAS A THIRD RAIL IN THE ORGANIZATION WHEN NCATS WAS STOOD UP IS THE IDEA THAT HE PUT IN ANY WAY CANNIBALIZE ANY OTHER IC BUDGET SO IN A SENSE THAT THERE IS A ZERO SUM CONCERN THAT THIS HAD TO BE NEW MONEY HA COMES IN TO DO THIS. SO ARE WE SAYING THAT THAT IS WHAT REALLY IS GOING TO HAPPEN WITH THE POLITICAL CLIMATE CERTAINLY SUPPORT ONE FIFTH OF THE NIH BUDGET TO BE ARPA H, THAT'S THE SIZE OF ESSENTIALLY THE LARGEST INSTITUTE LIKE NCI AND NIAID WOULD BE STOOD UP FROM THE GET GO. >> I MEAN IF YOU -- LOOK AT THE DRAFT LEGISLATION, IT IS ALL DRAFT LANGUAGE IN TERMS OF APPROPRIATION. IT IS NEW MONEY, IT IS NOT CANNIBALIZING FROM THE NIH BUDGET. WE WOULD NOT ADVOCATE FOR THAT IN FACT WE DIDN'T, WE NAVIGATED HARD THAT THAT SHOULDN'T BE THE CASE. IF FACT I THINK BOTH THE HOUSE AND SENATE GAVE THE NIH INCREASES ON TOP OF THE FY 21 BUDGET FOR FY 22. THIS IS ALL DRAFT LANGUAGE, NOTHING HAS BEEN PASSED YET. >> THANKS, THAT WAS TERRIFIC. YOU EXPERTLY ANSWERED A LOT OF QUESTIONS AND WE REALLY APPRECIATE YOUR TIME HERE. THANK YOU FOR THE PRESENTATION. WE LOOK FORWARD TO SAYING ALONG WITH YOU HOW WE UPHOLD THIS GOING FORWARD AND HOPEFULLY WE CAN HAVE THIS BACK SOON AT COUNCIL. >> I APPRECIATE COPY OF THAT REPORT MENTIONED AT THE BEGINNING, WOULD LOVE TO SEE THAT. THANK YOU FOR INVITING ME. APPRECIATE THE ROBUST DISCUSSION AND I'M ASSURE JONI YOU AND I WILL TALK AGAIN. TAKE CARE. >> THANK YOU. >> THANK YOU SO MUCH. WITH THAT WE DID GET A LITTLE OVER IN TIME SO HOPE WE CAN MAKE UP FOR THAT IN THE NEXT COUPLE OF PRESENTATIONS. BUT WE ARE GOING TO MOVE ON TO LILY PORTILLA I BELIEVE IS NEXT TO TALK ABOUT THE OFFICE OF STRATEGIC ALLIANCE. SO LILY PLEASE GO AHEAD. >> CAN YOU HEAR ME? >> YEP. >> GREAT. HI, I'M LILY PORTILLA, DIRECTOR OF STRATEGIC ALLIANCES AT NCATS AND JUST TO ORIENT TO COUNCIL OUR OFFICE IS IN CHARGE OF ALL THE AGREEMENT AND PARTNERSHIP ESTABLISHMENTS THAT GO ON ACROSS THE CENTER, THE OTHER THING WE DO IS ALSO RUN THE SBIR STTR PROGRAM AND THE FOCUS OF MY CONVERSATION TODAY OR MY PRESENTATION TODAY IS GOING TO BE ON THE SBR STTR PROGRAM AND OUR EFFORTS AROUND THAT SPECIFIC PROGRAM, WITH THAT I WILL START. NEXT SLIDE PLEASE. SO THE NIH SBIR STTR PROGRAMS LARGEST SOURCES OF EARLY STAGE SEED FUNDING IN THE COUNTRY. BUDGET IS WELL OVER A BILLION DOLLARS NOW THAT ACROSS THE NIH THAT HAS TO GO TO U.S. SMALL BUSINESSES WORKING IN THE BIOMEDICAL SPACE AND 24 INSTITUTES INCLUDING NCATS HAVE BUDGETS THAT SUPPORT THE SBIR STTR PROGRAM. IT IS A 3.65% SET ASIDE, IT IS A CONGRESSIONALLY MANDATED PROGRAM, IT IS NOT MONEY THAT CAN BE REPROGRAMMED TO OTHER GRANT LINES OR CONTRACT LINES, IT HAS TO BE USED IN SUPPORT OF U.S. SMALL BUSINESS. LET'S GO TO NEXT SLIDE. LET'S CLICK ONE MORE TIME. MAJORITY OF APPLICATIONS THREE WAYS APPLICATIONS COME IN FOR THIS PROGRAM. THE MAJORITY OF THE APPLICATIONS COME IN WHAT'S CALLED THE OMNIBUS THAT IS 24 PARTICIPATING INSTITUTES UTILIZES WELL AS OUR SISTER AGENCIES AT THE CDC AND FDA, OTHER PARTS OF HHS. I WOULD SAY ABOUT 90% APPLICATIONS THAT WE GET IN ARE FUNDED THROUGH THE OMNIBUS WHICH IS BROAD TOPICS ACROSS THE NIH NCATS HAS LISTED THOSE RESEARCH PRIORITIES AS PART OF THE OMNIBUS SOLICITATION. THE OTHER WAY WE GET APPLICATIONS IS LIEU TARGETED SOLICITATION, WE HAVE A FEW OF THEM WE GENERATED HERE AT N CATS, WE ALSO PARTICIPATE IN SOLICITATION OTHER INSTITUTES HAVE PUT TOGETHER. ONCE A YEAR THERE IS A CONTRACT SOLICITATION AND THIS IS WHEN SPECIFIC DELIVERABLE -- WE BELIEVE A SPECIFIC DELIVERABLE CAN BE TARGETED BY SMALL BUSINESS AND I WANT TO CLARIFY THAT IT IS NOT LIKE A SERVICE, WE ARE NOT ASKING FOR A SERVICE TO BE PROVIDED BY A SMALL BUSINESS BUT WE ARE SAYING THAT WE THINK THERE'S A TECHNOLOGY SOLUTION PROVIDED BY SMALL BUSINESS AND THE CONTRACT MECHANISM WHICH HAPPENS ONCE A YEAR, IS BEST WAY THE GET THOSE, WE BROAD THOSE TO YOU ALL AND COUNCIL THE APPROVE. SBIR STTR HAS SEVERAL BENEFITS AS I MENTIONED LEAD TO OVERALL BUDGET SO IT IS STABLE AND PREDICTABLE,IT IS NON-DILUTIVE. THE GOVERNMENT DOESN'T TAKE IP RIGHTS DEVELOPED UNDER THIS PROGRAM. ONCE IN THE PROGRAM, ONCE YOU RECEIVE A GRANT YOU GET ACCESS TO SOME TECHNICAL ASSISTANCE AND COMMERCIALIZATION PROGRAMS THAT THE NIH OFFERS ALONGSIDE OF WITH THE GRANT WE FOR EXAMPLE OFFER COMPANIES OPPORTUNITY TO GO THROUGH INNOVATION CORE TRAINING PROGRAM. WE WILL PAY FOR THEM TO DO THAT. WE ALSO NIH HOST IN LARGE CONFERENCES LIKE BIO AND ABMED HAVE SPACE WHERE MANY COMPANIES CAN DO PITCHES TO POTENTIAL INVESTORS AS WELL TOO, THAT IS ANOTHER BENEFIT OF BEING IN THE PROGRAM. I BELIEVE I MENTIONED THAT BEFORE THAT, ONE OF THE OTHER BENEFITS IS THAT THE PROGRAM -- THE GRANTS AND CONTRACTS GO THROUGH RIGOROUS PEER REVIEW PROCESS, WHICH THEY CAN THEN LEVERAGE FOR ADDITIONAL FUNDING THROUGH OTHER SOURCES, PRIVATE INVESTMENT, AND EVEN STATE ECONOMIC ORGANIZATIONS HAVE COMPLIMENTARY PROGRAMS ONCE YOU GET AT NIH SBIR STTR. IT IS THREE PHASE PROGRAM, PHASE 1 IS FEASIBILITY STUDIES AND THERE ARE PROGRAM CAPS BUDGET CAPS THAT THE NIH HAS TO ADHERE TO THAT ARE SET BY THE SMALL BUSINESS ADMINISTRATION. HOWEVER, THERE ARE SOME TOPICS ACROSS THE NIH THAT WE HAVE ALLOWED HIGHER BUDGET DOLLAR AMOUNTS, PHASE 2 IS MORE FULL ADD PROGRAMS WE CAN GO UP TO 2 MILLION OVER PROJECTS THAT LAST BETWEEN TWO TO THREE YEARS. THE FAST TRACK THAT COMBINES BOTH THE PHASE 1 AND PHASE 2 ONE REVIEW THE COMPANY HAS TO GO THROUGH. DIRECT TO PHASE 2 WHICH ALLOWS YOU TO SKIP THE PHASE 1 IF YOU HAVE ENOUGH DATA YOU HAVE GOTTEN UNDER FEASIBILITY STUDY. AND THE PHASE 2B COMPETING RENEWAL PROGRAM WE OFFER TO ONLY COMPANIES THAT WE FUND IN PHASE 2. UNLIKE OTHER AGENCIES WITH STIR SBIR, WE DO NOT HAVE A PHASE 3 PROGRAM BUT WE PRESUME COMPANIES ARE GRADUATING OUT OF THE PROGRAM AND PSYCHING PRIVATE SOURCES OF FUNDING, OR DEVELOPING STRATEGIC PARTNERSHIPS. HOPEFULLY THE GRANT HAS GOT TO THAT KEY INFLECTION POINT WHERE THEY CAN DO THAT. NEXT SLIDE. THERE ARE -- I WON'T GO THROUGH THE DIFFERENCES BETWEEN GUIDELINE AND ELIGIBILITY REQUIREMENTS BUT THERE ARE -- THE MAIN DIFFERENCE BETWEEN THE TWO OF SBIR AND STTR IS THE STTR HAS -- MUST HAVE A RESEARCH INSTITUTION COMPONENT TO IT. IN THAT INSTANCE THE PI CAN EITHER WORK FOR THE RESEARCH INSTITUTION OR CAN WORK FOR THE SMALL BUSINESS. BUT KEEP IN MIND THAT THE GRANT ALWAYS HAS TO GO TO THE SMALL BUSINESS. THERE ARE WORK REQUIREMENTS DIFFERENCE BETWEEN PROGRAMS NOT ALL GRANT CAN BE OUTSOURCED, MANY TIMES WE HAVE VIRTUAL COMPANY ASKING IF THEY WANT TO PARTICIPATE IN THE PROGRAM BUT THERE HAS TO BE WORK DONE WITHIN THAT SMALL BUSINESS IN ORDER TO BE ELIGIBLE TO RECEIVE THE AWARD. NOW I WILL GET INTO INITIATIVES AND PROGRAM CHANGES ACROSS THE NIH. NEXT SLIDE. THERE HAVE BEEN CHANGES TO THE BUDGET CAPS, THERE WAS A PERIOD OF TIME THERE WHERE THE BUDGET CAP STAYED STATIC OF SMALL BUSINESS ADMINISTRATION OVER SEVERAL YEARS HAS INCREASED THAT WE ARE NOW UP TO 275 AND CHANGE FOR PHASE 1 AND 1.8 MILLION FOR PHASE 2. THERE ARE TOPICS AT THE NIH DOES ALLOW FOR HIGHER BUDGET AMOUNTS AND THEY ARE CALLED WAIVER TOPICS. EACH INSTITUTE HAS THEIR WAIVER TOPICS THAT YOU CAN APPLY UNDER AND FOR US THE WAIVER TOPICS ALLOW YOU TO GO UP TO 325,000 FOR PHASE 1. 2 MILLION FOR PHASE 2. WE THINK THAT THAT IS WARRANTED FOR SOME TOPICS BUT WE BELIEVE OUR BUDGET CAN SUPPORT THESE HIGHER BUDGET DOLLAR AMOUNTS. NEXT SLIDE PLEASE. THERE'S ALSO CHANGES AROUND TECHNICAL AND BUSINESS ASSISTANCE PROGRAM. COMPANIES NOW REQUEST IN ADDITION TO THE -- THEIR BUDGET THEY CAN ASK FOR 6,500 PER YEAR PHASE 1 AND 50,000 FOR PHASE 2, IT WOULD ALLOW THE COMPANY TO DO THINGS LIKE MARKET ANALYSIS, OF TECHNOLOGY, PATENT LANDSCAPE OR FILING PATENTS BUT THIS IS A NEW INITIATIVE THAT IS STARTED NIH OFFERS COMPANIES THAT ARE INTERESTED CONSULTING SERVICES TO FIGURE TECHNOLOGY TO A INFLECTION POINT TO GET STRATEGIC PARTNERSHIP OR INVESTMENT BUT THE TECHNICAL ASSISTANCE FUNDING IS VERY HELPFUL IN TERMS OF DOING THAT. NEXT SLIDE PLEASE. I ALSO WANT TO POINT OUT THAT LIKE OTHER NIH GRANT PROGRAMS SBIR STTR TAKES ADMINISTRATIVE SUPPLEMENTS TO PROMOTE DIVERSITY. IN THIS INSTANCE THE -- THIS PARTICULAR ADMINISTRATIVE SUPPLEMENT IS IN SUPPORT OF INDIVIDUALS WHO WANT TO WORK IN SMALL BUSINESS AND GET EXPERIENCE AS PART OF THE C SUITE OR DOING RESEARCH FOR THE SMALL BUSINESS AND I WANT TO NOTE THIS IS A SPECIAL ADMINISTRATIVE SUPPLEMENT ONLY FOR SBIR STTR COMPANIES. WE ALSO PARTICIPATE WITH NINE OTHER INSTITUTES IN THE APPLICANT ASSISTANCE PROGRAM AND HERE APPLICANTS THAT HAVE EITHER NEVER APPLIED TO THE NIH OR APPLIED NOT SUCCESSFUL AND GIVEN A MENTOR TO WORK WITH PUTTING APPLICATION TOGETHER, HONING TOPICS AND THE CONSULTANT THAT WORKS WITH THEM HAS A LOT OF EXPERIENCE WORKING WITH -- HELPING COMPANIES WITH NIH GRANTS AND WHAT IT DOESN'T DO, IT DOESN'T WRITE THE GRANT FOR THEM BUT GIVES THEM THE TOOLS AND KNOWLEDGE NEEDED TO BE SUCCESSFUL IN GETTING NIH FUNDING. THE PROGRAM DOES HAVE A FOCUS ON SUPPORTING WOMEN AND MINORITY OWNED SMALL BUSINESSES AS WELL. TO THE NEXT SLIDE. HERE WE KIND OF TALK I THINK I MENTIONED A FEW THINGS HERE, THAT IF YOU ARE TO BE ELIGIBLE YOU HAVE NEVER GOTTEN NIH GRANT, COMPANY DOESN'T HAVE CURRENT APPLICATION UNDER REVIEW, WE AGAIN TRY TO MAKE SURE THAT THESE INTERESTS OF FOCUS OF THE APPLICATIONS ALIGN WITH THOSE INTEREST OF THE PARTICIPATING INSTITUTES. MENT WE ARE LOOKING AT THE PROGRAM OVERALL TO DETERMINE WHETHER IT IS SUCCESSFUL AND HOPEFULLY NEXT TIME WE MEET I WILL BE ABLE TO PROVIDE MORE DATA AROUND THAT. WE FOLLOW SOMETHING LIKE REALLY WOULD BE A GOOD INVESTMENT OF TIME AND ENERGY TO TRY TO FIGURE OUT HOW TO HELP CERTAIN APPLICANTS GET OVER THIS HUMP OF GITTING FUNDING FOR UNDER THIS SPECIFIC PROGRAM. SO INITIATIVES WE ARE DOING AROUND OUTREACH AND DRIVING AWARENESS TO THE NCATS SBIR STTR PROGRAM, NEXT SLIDE SO OUR OBJECTIVES ARE GETTING PEOPLE TO BE AWARE OF WHAT TYPES OF PROJECTS WE ARE FUNDING UNDER THE PROGRAM, TO INCREASE THE NUMBER OF APPLICATIONS THAT WOMEN OWN AND MINORITY OWNED SMALL BUSINESSES APPLY TO US INCREASING THOSE NUMBERS OF QUALITY APPLICATIONS, ALSO SMALL BUSINESSES IN STATES THAT TYPICALLY DON'T GET A LOT OF NIH FUNDING EITHER TRYING TO FOCUS EFFORTS AND OUTREACH AROUND THAT TOO, IN GENERAL ADVANCING INVASION AND DRUG DEVELOPMENT DISCOVERY RESEARCH TOOLS AND TECHNOLOGIES THAT IMPROVE PATIENT CARE AND THOSE RESEARCH TOPICS THAT ARE OF GREAT IMPORTANCE AND PRIORITY TO NCATS. NEXT SLIDE. THIS PAST YEAR EVEN THOUGH WE WEREN'T ABLE TO DO IN PERSON OUTREACH WE DID A FAIR AMOUNT OF WEBINARS WE WERE QUITE BUSY AND PARTNERED WITH VARIOUS GROUPS TO GET WEBINARS IN PLACE, STATE BIO ORGANIZATIONS, AS WELL AS ACADEMIC TECH TRANSFER OFFICES, INNOVATION HUBS AND ACCELERATORS AND GOVERNMENTAL PARTNERS WE WORKED WITH TO DO JOINT OUTREACH EVENTS. I WANT TO POINT OUT WE HAVE BEEN BUSY THOUGH NOT ABLE TO DO IN PERSON OUTREACH. THIS PAST YEAR WE WERE ABLE TO GET PARTICIPATION TO WEBINARS FROM 45 STATES, AND 45 SATES WERE IDEA STATES, WHICH WE WERE PURPOSEFULLY TARGETING. THIS PAST YEAR WE TALKED TO A HUNDRED APPLICANTS AND -- I WILL TALK ABOUT HOW WE TRACK WHAT HAPPENS AFTER THOSE CONVERSATIONS WHAT HAPPENS TO THE APPLICANTS BUT THIS YEAR WE WANT TO TARGET OTHER STATES WE WEREN'T ABLE TO MAKE IN ROADS IN AND THERE'S ONLY A FEW OF THEM HERE THAT WE HAVE LISTED. BUT THAT IS PRIORITY NUMBER ONE GOING INTO FY 22. NEXT SLIDE. WE HAVE A SOCIAL ENGAGEMENT CALENDAR WE PUT TOGETHER EVERY MONTH WITH OUR COMS TEAM. WE HAVE GOTTEN TRAFFIC AS A RESULT OF THE EFFORTS WE HAVE BEEN DOING EVERY TUESDAY WE HAVE A TIP TUESDAY SOCIAL ENGAGEMENT THAT GOES OUT ABOUT HOW TO PUT IN AN APPLICATION TOGETHER, ADVISING APPLICANTS WHAT TO DO FOR PARTICULAR FUNDING ANNOUNCEMENT. WE HIGHLIGHT NCATS STAFF INVOLVED WITH THE PROGRAM UPCOMING WEBINARS. ANOTHER THING THAT IS VERY SUCCESSFUL ARE THESE QUOTE CARDS HIGHLIGHT SOME OF OUR GRANTEES AND SPECIFICALLY SOME HIGHLIGHT AROUND COMPANIES, MILESTONE THEY REACHED IF WE CAN GO TO THE NEXT SLIDE. BY WAY OF EXAMPLE, THIS PAST YEAR WE HAVE WORKED CLOSELY WITH OUR PROGRAM OFFICERS AND ALSO HAVE ALERTS SO WE KNOW WHEN COMPANIES WE HAVE FUNDED HAVE GOTTEN ACANNINGAL FUNDING OR CREATED A STRATEGIC PARTNERSHIP, WE TALKED TO THAT GRANTEE, TO FIND OUT WHAT IS GOING ON. AND AMPLIFY THE FACT THAT THEY HAVE REACHED A MILESTONE. GREAT WAY ENGAGING COMPANY BUT ALSO OTHERS ABOUT GOOD WORK WE ARE DOING WITH PROGRAM AND ENTREPRENEURS THAT WE ARE FOCUSING AS PART OF THE SOCIAL ENGAGEMENT OPPORTUNITIES HERE. NEXT SLIDE. /TALK ABOUT FACT WE HAVE HAD -- WE DID 100 INDIVIDUALCALS WITH INDIVIDUALS WHO NEEDED TO TALK TO US ABOUT PROJECTS AND WE -- WHEN WE FIRST STARTED OUT WE HAD A HARD TIME TRACKING WHO WE SPOKE TO BUT MORE IMPORTANTLY WHAT HAPPENED AFTER THAT CONVERSATION. SO NOW WE ARE UTILIZING SALES FORCE TO GIVE US AN IDEA OF WHEN THESE CONVERSATIONS HAPPEN, HOW LONG DOES IT TAKE THE APPLICANT TO I APPLY TO THE PROGRAM AND ONCE THEY APPLY, HOW SUCCESSFUL WERE THEY. ARE THEY APPLYING FOR OTHER GRANTS AND NOW THIS -- OUR SALES FORCE APPLICATION IS ABLE TO TALK TO THE NIH SYSTEM SO WE ARE ABLE TO SEE REAL TIME GRANTS AT THESE POTENTIAL APPLICANTS HAVE AND TRACK WHAT CONVERSATIONS HAVE LED TO. IT IS A GREAT TOOL TO KEEP TRACK OF CERTAIN CAMPAIGNS THAT WE ARE DOING WEBINARS, WHAT'S BEEN THE INTEREST AROUND PARTICIPATION POST WEBINAR WITH FOLKS COMING TO NCATS, APPLYING TO THE PROGRAM. I WILL GIVE DATA, I TALKED INITIATIVES AROUND THE PROGRAM SO NOW THIS TIME THE TALK TO DATA SO LET'S DO THAT. QUICKLY TO GIVE YOU SENSE OF PROGRAM, IT IS 25 MILLION THAT GOES TO FUNDING SMALL BUSINESSES SBIR STTR. AT ANY GIVEN YEAR E WE HAVE ABOUT I WOULD SAY LIKE A 15 TO 80 -- 15 OR 20% OF OUR BUDGET GOES TO FUNDING THOSE SBIR CONTRACTS THAT I MENTIONED EARLIER AND THE REST REALLY GOES TOWARDS SUPPORTING THE GRANT PROGRAM. TO THE NEXT SLIDE. IF YOU WERE TO LOOK AT OUR PORTFOLIO THIS PACIFIST WALL YEAR I WOULD SAY THAT THEY FALL INTO FOUR BUCKETS THE MAJORITY ARE AROUND TOOLS AND TECHNOLOGIES FOR DRUG DISCOVERY AND DEVELOPMENT, IT IS A BROAD TOPIC, WE ALSO HAVE DEVICE PORTION OF OUR PORTFOLIO A LOT OF OUR TISSUE CHIP FALLS UNDER THAT SLIVER OF DEVICE. GENE THERAPY BECAUSE WE HAVE A FOCUS PROGRAM ANNOUNCEMENT AROUND GENE THERAPY AND THEN THE REST AROUND BIOINFORMATICS. SO THIS IS SHOWING OVER TIME THE NUMBERS OF APPLICATIONS THAT WE HAVE BEEN GETTING IN AND COUPLE OF OBSERVATIONS. ONE WE DON'T TALK ABOUT THIS PROGRAM WE DON'T SEE -- PEOPLE DON'T APPLY SO YOU HAVE TO IN ORDER TO GET PEOPLE/NEW FRESH GRANTEES TO THE MIX YOU NEED TO BE TALKING ABOUT THE PROGRAM AND DOING OUTREACH ON A PRETTY CONSISTENT BASIS. THE OTHER THING WE NOTICED WAS A DROP IN 2020 OF APPLICATIONS AND MANY APPLICANTS THOUGH HOME BOUND HAD TIME, THEY HAD OTHER RESPONSIBILITIES, I KNOW THAT ANECDOTALLY SEVERAL APPLICANTS SAID IT WAS HARD TO WRITE A GRANT WHEN THEY WERE HAVING TO TAKE CARE OF KIDS OR PARENTS DURING COVID. SO WE DID SEE A DROP IN APPLICATIONS HAPPENING AND ALSO SOME OF OUR COMPANIES WERE IMPACTED BY THE FACT THAT THEY COULDN'T HIRE DURING THE PANDEMIC SO THAT DELAYED THEM PERHAPS MOVING FROM THE PHASE 1 TO THE PHASE 2. IN 2021 BESTARTED TO SEE AN INCREASE BACK -- WE STARTED TO SEE AN INCREASE BACK AGAIN IN NUMBER OF APPLICATIONS THAT CAME TO US. NEXT SLIDE. HERE WE ARE FOCUSING ON AWARDED APPLICATIONS. TYPICALLY AT ANY GIVEN TIME I THINK WE RUN ANYWHERE BETWEEN 25 TO 35 APPLICATIONS THAT WE -- NEW APPLICATIONS WE FUND EVERY YEAR. NEXT SLIDE. HOW DO -- WHAT ARE -- DOES OUR PRIORITY SCORE, WHAT ARE WE FUNDING THE QUESTION WE GET OFTEN AND I THINK OVER TIME WE HAVE SEEN IMPROVEMENT IN THE AVERAGE PRIORITY SCORES NCATS FUNDS IN SBIR, AGAIN PRETTY PREDICTABLE WHAT OUR BUDGET IS GOING TO BE SO WE KNOW WHETHER KIND OF OUTREACH THAT WE HAVE TO DO IN OUR APPLICANTS -- WE HAVE REPEAT GRANTEES WHO COME BACK TO US AND FUND VARIOUS PROJECTS. SO I DO THINK THAT IT IS LEVELING OFF AND THIS IS KIND OF WHAT FY 20 -- FY 21 WAS VERY COMPETITIVE YEAR. BECAUSE WE HAVE SEEN OUR APPLICANTS NOT COME IN FOR ADDITIONAL FUNDING BECAUSE THEY HAVEN'T BEEN ABLE TO FINISH THEIR AIMS AND GRANT BECAUSE OF COVID. I DO EXPECT IT TO BE A DIFFERENT NUMBER THIS NEXT IN THISY 2022. WE WILL SEE WHAT HAPPENS SO WHAT DO WE LOOK LIKE COMPARED TO THE REST OF NIH? NEXT SLIDE. WE ARE CLOSE. SOME YEARS WE ARE DOING BETTER THAN WHAT NIH AVERAGE PRIORITY SCORES ARE FOR SBIR AND SOME YEARS WE ARE DOING A LITTLE BIT WORSE. CONSISTENTLY WE ARE STAYING ALONG THE LINES OF WHAT NIH FUNDS FOR SBIR. TO THE NEXT SLIDE. EYE A LITTLE BIT DIFFERENT. COUPLE OF REASONS. ONE IS THAT OUR BUDGET IS NOT THAT HIGH FOR STTR SO OUR APPLICANTS COME IN AND FIGURE AND SAY I WILL TAKE A CHANCE AND GOING TO APPLY FOR SBIR BECAUSE I FEEL LIKE I HAVE A BETTER CHANCE THERE. SOME YEARS WHAT WE SEE IS DROP OFF IN NUMBER OF APPLICATIONS THAT COME IN UNDER SPECIFIC -- UNDER STTR. OTHER YEARS WE SEE A FEW PHASE 2s TAKE UM THE BUDGET WHICH LIMITS WHAT WE CAN FUND. SO FREE YEAR-TO-YEAR THERE IS FLUCTUATION WITH WHAT WE FUND UNDER THE PROGRAM. SHOWING HOW WE ARE DOING WITH REST OF NIH, I THINK IT HAS BEEN A LITTLE ALL OVER PLACE. DEPENDS ON WHETHER THERE'S A STREAM OF APPLICATIONS COMING IN, WHETHER THERE'S PHASE 2s TO FUND. APPLICANTS COMING IN SAYING I'M GOING TO PUT TOGETHER ABIR VERSUS STTR. ANOTHER THING WE HAVE BEEN TRACKING TO IS WOMEN OWNED AND MINORITY OWNED SMALL BUSINESSES COMING AND APPLYING. DROVES A DROP OFF IN 2019. WE ACCOUNT THAT TO CHANGE IN HOW DATA IS COLLECTED. THE DATA USED TO BE COLLECTED AT THE NIH LEVEL WITHIN YOU PUT YOUR APPLICATION IN, YOU WOULD TAKE WHETHER YOU WERE MINORITY OWNED OR WOMAN OWNED SMALL BUSINESS VERY DEPENDENT ON SBA GUIDELINES. NOW THAT DATA IS CAPTURED ON THE SBA SITE SIDE WHEN YOU REGISTER, YOU DO YOUR SBA REGISTRATION. AND WE HAVE SEEN A SHIFT IN THE NUMBERS. IF YOU LOOK LOOK AT HER PARTS OF NIH YOU SEE SIMILAR SHIFTS AS WELL TOO IN TERMS OF DATE CAPTURE. TO THE NEXT SLIDE. I WILL END WITH SUCCESSORRIES. AS PART OF THE TEN YEAR ANNIVERSARY WE TALKED ABOUT WHAT WE DID ON I BELIEVE DECEMBER 7 WE HAD THIS BIG LOT OF PARTICIPATION AROUND THE TEN YEAR ANNIVERSARY BUT ALSO DECIDED TO DO SOMETHING WITH SBIR TOO AND HIGHLIGHT THREE SUCCESS STORIES WITH COUPLE OF OF OUR GRANTEES. LET ME GO THROUGH SOME OF THE STORIES. I WANT O GET A GOOD REPRESENTATION OF DIFFERENT PARTS OF THE ENTREPRENEURIAL CYCLE TO GIVE ILLUSTRATE HOW THESE COMPANIES USE THE GRANT MORE IMPORTANTLY HOW THEY HAVE GOT TO KEY INFLECTION POINTS ALONG THE WAY -- MOVING THEIR TECHNOLOGY FOR COMMERCIALIZATION. LET'S GO TO NEXT SLIDE. WE HAD DR. LIN PARKS WU WHO DEVELOPED THIS PORTABLE SYSTEM CALLED THE BLAZE SYSTEM WHICH COMBINES MASS SPEC WITH PROTEIN IMAGING AND LEONA WAS ABLE TO DO THIS WITH DEVELOPMENT WITH SBIR BUT SHE SOLD HER COMPANY TO (INAUDIBLE) AS A RESULT OF THAT SO THE COMPANY WAS INTEREST MISDEMEANOR THE PRODUCT AND HER EXIT STRATEGY WAS TO SELL THE ASSET WHICH IS WHAT SHE DID SHE WAS SUCCESSFUL IN DOING THAT BUT SBIR HELPED WITH THE EARLY DEVELOPMENT OF THE TECHNOLOGY. THE NEXT PERSON WAS CHRIS GIBSON, CHRIS SURE YOU HAVE HEARD ABOUT RE,CURSION. ONE OF THE FIRST COMPANIES WE FUNDED WHEN WE STARTED THE CENTER. IT EAT A GREAT STORY BECAUSE THAT INITIAL GRANT THAT CHRIS WENT FOR OVER TIME COMPANY WAS ABLE TO LEVERAGE INVESTMENT, CHRIS'S COMPANY WAS SUPPORTED BY NIH GOING TO VARIOUS PITCH PETITION THAT BIO HAD AND OTHER CONFERENCES HE COULD SHOWCASE WHAT HE WAS DOING AND TECHNOLOGY BUT ONE OF THE KEY THINGS WITH RECURSION WAS THEY MEET THE PINNACLE MILESTONE LISTED AS NASDAQ COMPANY THIS PAST YEAR WHICH IS A WONDERFUL STORY AND YES THE GRANT HELPED BUT CHRIS'S VISION AND WHAT HE'S DONE IS REALLY PAVED THE WAY TO SUCCESS OF THE COMPANY. THEN THE OTHER GRANTEE WE FOCUSED ON WAS DR. CHANG KIM BASED IN MILWAUKEE, WISCONSIN. HE HAD THIS POINT OF CARE TECHNOLOGY THAT WE WERE FUNDING FOR DIARRHEAL DISEASE AND WHEN COVID CAME IN HE SAID I THINK I CAN PIVOT AND START ADDRESSING COVID USING THE SAME PLATFORM. AND THAT IS WHAT HE DID, HE GAVE A SUPPLEMENT TO DO THAT. AND CHANG HE IS WORKING DILIGENTLY TO GET AUTHORIZATION FOR THE TECHNOLOGY TO BE USED, HE HAS A PORTAL VAN HE GOES AROUND MILWAUKEE USING HIS POINT OF CARE TECHNOLOGY TO GET COVID TESTS AND HE'S BEEN A GREAT SUCCESS STORY FOR US AND SHOWING HOW YOU CAN PIVOT PLATFORM TECHNOLOGIES AND IN THIS CASE WE OFFER THE SUPPORT TO GET HIM TO THAT NEXT CRITICAL STAGE. GO TO NEXT SLIDE. FUTURE DIRECTIONS FOR SBER STTR, FOCUS ON INCREASING PARTICIPATION OF WOMEN AND MINORITY OWNED SMALL BUSINESS, WE WANT TO CONTINUE TO IDENTIFY SUCCESS STORIES IN WAYS OF AMPLIFYING OUR COMPANIES REACHING PIVOTAL MILESTONES THAT SHOW EFFECTIVENESS OF THE PROGRAM, PROVIDING EDUCATIONAL PROGRAMMING TO GRANTEES HOW TO APPLY TO THE PROGRAM, WHAT WE ARE LOOKING FOR SPECIFICALLY HERE AT NCATS AND MORE IMPORTANTLY, HOW TO LEVERAGE WHAT WE ARE DOING HERE AT NCATS IN TERMS OF SCIENTIFIC PRIORITIES AND SEEING SBIR STTR AS A WAY OF ALSO GETTING THERE. SO IN TERMS OF ASPR COUNCIL MEMBERS I WE ARE ALWAYS LOOKING FOR OPPORTUNITIES TO DO OUTREACH FOR THE PROGRAM, IF YOU HAVE SUGGESTION WE WELCOME THOSE. AND IDEAS HOW TO LEVERAGE SBIR WITH OTHER NCATS INITIATIVES AND PROGRAMS, WE AGAIN HAPPY TO LISTEN AND I'M GOING TO OPEN IT UP FOR QUESTIONS. >> I WAS GOING TO FILE IN OUTREACH RECOMMENDATIONS -- GOING TO TIME IN OUTREACH RECOMMENDATIONS. I DON'T HAVE ANY QUESTIONS. JUST A COUPLE OF LEADS FOR HER. >> FANTASTIC. THANK YOU SO MUCH KELLY, APPRECIATE THAT. >> HI, LILY. ONE OF THE THINGS YOU MIGHT THINK ABOUT IN EXTENDING THIS IS REALLY IN THAT ACT AND USING MENTORS IS TO ALSO PARTNER TOGETHER WITH THE CTSA PROGRAMS AND OTHERS WHICH COULD REALLY USE LOCAL MENTORS SUCCESSFULLY TRAVERSES BOTH FROM ACADEMIC AND BUSINESS SIDE THAT COULD WORK TOGETHER WITH EXTENDING REACH, ALSO MAKE IT RELEVANT WITHIN THE OWN COMMERCIALIZATION SYSTEMS WITHIN OUR ECONOMIC DEVELOPMENT THINGS WITHIN THE STATES AND MIGHT HELP THAT SUSTAINABILITY AS YOU GO PHASE 1 TO PHASE 2 AND THIS LESSONS LEARNED THAT I THINK MAKE TEAMS MORE SUCCESSFUL. >> THANKS, BECKY. WE HAVE HAD VERY SUCCESSFUL ENGAGEMENT WITH VARIOUS CTSAs THAT HAVE PARTNERED WITH US TO TALK ABOUT THE PROGRAM. IN FACT LAST WEEK WE HAD A WEBINAR WITH A COMPANY THAT WAS STARTED FROM A K 1 SCHOLAR AT UT HOUSTON AND HE LICENSED TECHNOLOGY INTO THE COMPANY. ALSO PARTNERED WITH AN EXPERT WITHIN LOCAL CTING ISA. WE TALK ABOUT HOW TO ENGAGE WITH THE CTSA PROGRAM IF YOU ARE SMALL BUSINESS HOW YOU GO ABOUT DOING THAT. THE WEBINAR WAS VERY SUCCESSFUL IN TERMS OF MAKING TALKING THE STORY HOW TO BRIDGE THE TWO PROGRAMS, I WOULD LOVE TO SEE MORE OF THAT OVER TIME AS WELL TOO. MAYBE WE CAN TALK SEPARATELY AND GIVE ME MORE IDEAS ON WHERE TO GO. >> LOVE TO, WE CAN TALK OFFLINE. >> ANY OTHER QUESTIONS FOR LILY? >> LILY HOW PRESCRIPTIVE CAN YOU MAKE THE RFAs IF YOU WILL FOR THESE? IS IT JUST SORT OF OPEN EVERYTHING OR CAN YOU DO TARGETED ANNOUNCEMENTS? >> ABSOLUTELY WE CAN DO TARGETED ANNOUNCEMENTS. YES. OUR OMNIBUS TOPICS ARE ON THE BROADSIDE BECAUSE WE WANT TO CAPTURE AS MUCH AS WE POSSIBLY CAN WITH THAT. BUT WE DO TARGET SOLICITATION, ORDR IS VERY SUCCESSFUL IN LEVERAGING WHAT THEY -- THEY ARE DOING USING THE TARGETED SOLICITATIONS. THEY HAD A BASKET TRIAL RFA USING A U MECHANISM ABOUT WE USED A U 44 MECHANISM ON THE SBIR AS COMPLIMENTARY WAY OF GETTING SMALL BUSINESS ENGAGED. SO IT IS VERY MUCH SOMETHING THAT WE WANT TO SEE MORE OF GOING FORWARD AND FIGURING HOW TO LEVERAGE CURRENT PROGRAMS AND INITIATIVES USING SBIR STTR. >> COUPLE OF FOLLOW UPS. DOES THE END RESULT NEED TO BE A PRODUCT OR IT -- CAN IT BE A SUSTAINABLE SET OF SERVICES? >> TYPICALLY A PRODUCT. IN TERMS OF SUSTAINABLE SERVICE, IF THERE IS SOMETHING UNIQUE ABOUT INNOVATIVE ABOUT THAT SERVICE, THAT REQUIRES PERHAPS A PLATFORM OF SOME SORT TO DO, WE HAVE MANY COMPANIES THAT OFFER DRUG DEVELOPMENT SUPPORT AND DO IT AS PART OF SERVICE BUT IT IS THE TECHNOLOGY THEY USE BEHIND THE SCENES THAT IS THE INNOVATION THAT WAS FUNDED BY SBIR, THAT WOULD BE POSSIBLE. >> WHERE MY HEAD IS ON YOUR SECOND QUESTION THINKING BACK TO JONI'S AUDACIOUS GOALS, LOOKING AT WHERE THE GAPS ARE THAT MAY WELL NOT BE EASY TO FILL USING TRADITIONAL METHODS, SEEMS LIKE TARGETED ANNOUNCEMENTS MIGHT OFFER A GOOD OPPORTUNITY. >> WE ARE UP TO EXPLORING HOW TO MAKE THAT HAPPEN. IN SOME INSTANCES HAVING THE TARGETED ANNOUNCEMENTS IS GOING TO GET YOU MORE WHERE YOU IMMEDIATE TO GO, MAYBE THAT IS EXACTLY IN TERMS OF BRIDGING THOSE WITH JONI'S GOALS SHE MENTIONED, SPECIFICITY AROUND TARGETED SOLICITATION IS REALLY THE WAY TO GO OPPOSED TO BEING BROAD. >> LOVE THAT IDEA. ANY OTHER QUESTIONS FOR LILY? OKAY. HEARING NONE WE HAVE MADE UP SOME TIME. ANNA, QUICK PROCESS QUESTION HERE, SHOULD WE TAKE A BREAK? OR PROCEED WITH THE LAST BIT OF THE COUNCIL CONCEPT CLEARANCES? >> JONI, I THINK FOLKS WOULD APPRECIATE A SHORT BREAK. WE DO HAVE TIME, WE ARE 20 MINUTES AHEAD OF SCHEDULE. SO TEN MINUTE BREAK WOULDN'T BE PROBLEMATIC AT ALL. >> SOUNDS GREAT. EVERYBODY IN TEN MINUTE BREAK. ALL RIGHT. LET'S DO IT. SEE YOU BACK IN ABOUT TEN A LITTLE AFTER TEN OF 4. SEE YOU SOON. SO NEXT UP IS THE CLEARANCE OF CONCEPTS AND WE HAVE A COUPLE FOR TODAY AND WE HAVE A COUPLE FOR TOMORROW. THE FIRST ONE WITHINOR WILL BE WITH OFFICE OF POLICY COMMUNICATIONS AN EDUCATION CONCEPT AND PENNY BURGOON WILL KICK OFF AND THEN WE WILL HEAR FROM JESSICA TAGLE BADGER. >> THANK YOU, GOOD AFTERNOON, EVERYBODY. HERE TO OVERVIEW OFFICE OF POLICY COMMUNICATIONS AND EDUCATION. I WILL ALSO WEAVE INTO A BRIEF INTRODUCTION ABOUT THE CONCEPT FOR THE EDUCATION BRANCH. NEXT SLIDE PLEASE. THE OFFICE OF POLICY COMMUNICATIONS AND EDUCATION OTHERWISE KNOWN AS OPIC PROVIDES GUIDANCE AND SUPPORT FOR NCATS ON NUMBER OF ACTIVITIES IN THE PURVIEW OF SCIENCE POLICY. COMMUNICATIONS AND OUTREACH. THE NEWEST BRANCH IS OUR EDUCATION AN TRAINING BRANCH. THIS IS A GROUP THAT WAS -- WE HAD THE ORGANIZATIONAL APPROVAL PROBABLY AROUND 2017 BUT WE WERE NOT ABLE TO STAFF THE -- THIS BRANCH UNTIL 2019. NEXT SLIDE PLEASE. NOW, THE GOALS OF THE EDUCATION BRANCH ARE TO DISSEMINATE AND DEVELOP EVIDENCE BASED TOOLS AND BEST PRACTICES. TO IMPROVE THE UNDERSTANDING OF TRANSLATIONAL SCIENCE. AND IN THAT GOAL THEY ALSO HOPE TO EXPAND AND DIVERSIFY TRANSLATIONAL SCIENCE WORK FORCE. THE BRANCH AIMES TO ACHIEVE THESE GOLDSBY COORDINATING AND PROVIDING CENTRAL LEADERSHIP TO NCATS TRANSLATIONAL EDUCATION ACROSS THE CENTER. SO THEY WORK WITH ALL THE CENTER DIVISIONS AND OFFICES, IN DEVELOPING NEW INITIATIVES LED BY THIS BRANCH AND LEADING CENTER WIDE AND ALSO LEAVE A CENTER WIDE COMMITTEE FOCUSED ON TRANSLATIONAL SCIENCE EDUCATION. HERE IS AN EXAMPLE OF THE ACTIVITIES THEY STOOD UP IN THE SHORT TIME THEY HAVE BEEN IN EXISTENCE. THE 501 COURSE IS ONLINE COURSE INITIATED BY EDUCATION BRANCH AND THIS WAS TO BUILD ON EXISTING EFFORTS BY N CATS COURSES TO TEACH PRINCIPLES OF TRANSLATIONAL SCIENCE. THEY ARE WORKING WITH OUR COMMUNICATION BRANCH TO IMPRINT SOME OF THESE IMPORTANT PRINCIPLES IN TERMS OF BADGES TO HELP EXEMPLIFY SOME OF THE IDEAS AROUND TRANSLATIONAL SCIENCE THAT WE THINK NEED TO HAVE A PARTICULAR EMPHASIS. HERE ARE THINGS WE ARE WORKING ON, THIS IS IN DEVELOPMENT, IT IS NOT OUT THERE YET BUT THIS IS AN EXAMPLE OF THINGS WE ARE TALKING ABOUT IN TERMS OF HOW WE LOOK AT THE SCIENCE OF TRANSLATION AND WHAT THE WORK FORCE, WHAT NEED TO BE EXPERT GAINED EXPERTISE IN. WITH THAT THIS WILL LEAD TO NEW CONCEPT CLEARANCE AND I WILL HAND THIS OVER TO DR. JESSICA BADGER EDUCATION BRANCH CHIEF. >> THANK YOU, THIS IS A PROPOSAL TO DEVELOP A PORTFOLIO OF EXTRAMURAL RESEARCH EDUCATION AWARDS THAT RESULT IN A SUITE OF ONLINE EDUCATION ACTIVITIES THAT CENTER TEACHING EFFECTIVE PRACTICES AND CORE PRINCIPLES OF TRANSLATIONAL SCIENCE. WITH KNOW THERE IS A NEED FOR CURRICULAR ACTIVITIES THAT DISSEMINATE EFFECTIVE PRACTICES AND TRANSLATIONAL SCIENCE BASED ON OUR ACTIVITIES INCLUDING EXTENSIVE LIT REVIEW AND EXPERIENCE WITH OUR INTERNAL TRAINING PROGRAM AND MOST IMPORTANTLY WE RECEIVED THIS FEEDBACK FROM THE COMMUNITY. AS YOU HEARD FROM DR. BERRIGAN THE EDUCATION BRANCH -- BURGOON THROUGH DEVELOPMENT OF TWO ON LION COURSES THAT USE EXAMPLES OF SUCCESSFUL NCATS LED EFFORTS TO DEMONSTRATE HOW SPECIFIC RESEARCH ADVANCES CAN BE EXAMINED TO OFFER INSIGHT TO TRANSLATIONAL PROCESS IDENTIFY COMMON CHALLENGES THAT STYMIE TRANSLATIONAL PROJECTS AND SOLUTIONS THAT ARE APPLICABLE NOT ONLY TO THIS PARTICULAR CASE BUT ALSO MORE BROADLY TO RESEARCH INITIATIVES ACROSS THE TRANSLATIONAL SPECTRUM. THROUGH EXAMINING CASES N CATS STAFF ALSO IDENTIFIED THE SEVEN INITIAL PRINCIPLES FOR EFFECTIVE TRANSLATIONAL SCIENCE SHARED ON THE PRIOR SLIDE AND HAVE BEEN INCORPORATED INTO THESE COURSES. WE NOW WANT TO EXPAND UPON AND EXTEND THIS APPROACH THROUGH STIMULATING ADDITIONAL TRANSLATIONAL SCIENCE EDUCATION ACTIVITIES, OR WE CAN CALL THESE EDUCATION EXPERIMENTS, THAT FURTHER DEVELOP AND FORMALIZE TRANSLATIONAL SCIENCE FOR CONCEPTS APPROACHES AND STRATEGIES DERIVED FROM THE EXPERIENTIAL KNOWLEDGE IN THE FIELD. WE ALSO WANT TO DO THIS WITH AN EYE TOWARDS EXPANDING TRANSLATIONAL SCIENCE WORK FORCE ENHANCING WORK FORCE DIVERSITY ENSURING BROAD ACCESS TO ACTIVITIES AS WELL AS ENCOURAGING INNOVATION AND ONLINE TRANSLATIONAL SCIENCE EDUCATION. THESE AWARDS FUND FULL CYCLE FROM DEVELOPMENT TO IMPLEMENTATION TO EVALUATION OF THESE EDUCATIONAL ACTIVITIES. THIS PROPOSAL ALIGNS WITH TWO NCATS STRATEGIC GOALS, THAT IS ADVANCING TRANSLATIONAL SCIENCE BY UNCOVERING TRANSLATIONAL SCIENCE PRINCIPLES TO CATALYZE ADVANCES IN HEALTH INTERVENTIONS SO UNCOVERING PRINCIPLES AND TEACHING THOSE TO CURRENT FUTURE MEMBERS OF THE TRANSLATIONAL SCIENCE WORK FORCE. AND TO DO THAT, MEET STREAM GOAL THREE DEVELOPING FOSTERING INNOVATIVE TRANSLATIONAL SCIENCE TRAINING AND HIGHLY SKILLED CREATIVE AND DIVERSE TRANSLATIONAL SCIENCE WORK FORCE. WE REALLY SEE THIS AUGMENTING CURRENT EDUCATION TRAINING PROGRAMS. WE KNOW SOME CURRENT ACTIVITIES FOCUS ON THE CHARACTERISTICS OF THE TRANSLATIONAL SCIENCE BEING SKILLED COMMUNICATOR, DISTINCT PHASES OF TRANSLATION OR CONTENT AREAS RELATED TO TRANSLATION. BUT NOW WE WANT TO ADD TO THIS HOW DO WE EXPLORE TRANSLATIONAL SCIENCE BY LOOKING AT THE WHOLE SYSTEM. HOW DO WE IDENTIFY THESE EFFECTIVE PRACTICES AND TEACH THEM TO OTHERS, AND ARTICULATE THE BENEFITS OF A TRANSLATIONAL SCIENCE APPROACH. AND USING THESE PRINCIPLES COULD INVESTIGATE A SCIENCE MIND SET. THIS IS ESTABLISHING TRANSLATIONAL SCIENCE AS DISTINCT AREA OF STUDY. SO I MENTION WE HAVE DONE LIT REVIEW, I WILL SHARE ABOUT THE DATA HERE AS IT IS INFORMED OUR THINKING ON THIS. BUT WE WERE SPECIFICALLY LOOKING AT TRANSLATIONAL SCIENCE EDUCATION WHERE THERE WAS FORMAL CURRICULUM COMPONENT, EDUCATION OR COURSE, A WORKSHOP, SEMINAR SERIES AND THEN WHAT WAS TAUGHT OR CONVEYED WITHIN THOSE COURSES WORKSHOPS, ET CETERA. THIS IS SHOWING YOU CAN IMAGINE LIT REVIEW FOR TRANSLATIONAL SCIENCE EDUCATION YOU GET ARTICLES WHEN YOU NARROW DOWN SPECIFIC CURRICULUM COMPONENTS IT BECOMES FEW ARTICLES IN THE LITERATURE OVER THE SPAN WE LOOK AT FROM ABOUT 2005 THROUGH 2021. BASICALLY THE TAKE HOME MESSAGE IN THESE SLIDES THERE ARE CERTAIN SEGMENTS OF TRANSLATIONAL SCIENCE WORK FORCE WE ARE MISSING OR PEOPLE WHO WE WANTS BRING INTO THE WORK FORCE. AGAIN THIS WAS PRE-COVID WE KNOW A LOT HAPPENED WITH ONLINE EDUCATION IN THIS TIME. THERE WAS -- THERE WAS FEW ARTICLES MENTIONED ANYTHING ABOUT ONLINE COMPONENT. FROM OUR LITERATURE RESEARCH. WE ALSO ORGANIZED ARTICLES BASED ON FRAME WORK OF TRANSLATIONAL PRINCIPLES TO SEE WHERE GAPS OR ADDITIONAL EDUCATION NEEDS COULD EXIST AND AGAIN THIS SHOWS YOU THERE'S SOME THINGS THAT WE ARE TOUCHING ON FREQUENTLY LIKE TEAM SCIENCE BUT OTHER THINGS WE CAN BUILD OUT MORE. SO GIVE YOU SOME OF THE HIGHLIGHTS FOR THIS PROPOSAL, WHAT WE ARE PROPOSING IS FUNDING OPPORTUNITY FOR THE EXTRAMURAL COMMUNITY TO DEVELOP NEW EDUCATION OPPORTUNITIES TEACHING CORE TRANSLATIONAL SCIENCE CONCEPT, INCLUDING SCIENTIFIC OPERATIONAL PRINCIPLES KEY STRATEGIES AND APPROACHES USED EFFECTIVELY TO ADVANCE TRANSLATION LOOKING FOR THIS TO EXPAND AND DIVERSIFY TRANSLATIONAL SCIENCE WORK FORCE TO REACH PEOPLE NOT CURRENTLY REACHING WITH OUR CURRENT EDUCATION TRAINING PROGRAMS AND WE REALLY WANT TO STIMULATE INNOVATION AND EDUCATION CONTENT DESIGN. SO WHILE WE WANT THIS AVAILABLE IN AN ONLINE FORMAT WE ARE NOT FOCUSED IN ON THIS HAS TO BE TYPICAL ON LINE COURSE, THERE'S WAYS THIS CONTENT COULD BE DELIVERED. KEY PART OF THIS WILL BE EVALUATION. WE WANT THESE EDUCATION ACTIVITIES EVALUATED TO USE TO ESTABLISH EVIDENCE BASED FOR EFFECTIVE APPROACHES IN TEACHING TRANSLATIONAL SCIENCE CONCEPTS. SO AT NCATS WE SAY EVERYTHING IS AN EXPERIMENT WE ARE NOT AFRAID FOR THIS TO BE AN EXPERIMENT AND FOR US TO LEARN WHAT WORKS. THE NEXT SLIDE SPEAKS MORE TO SOME OF THE THINGS WE WOULD LIKE TO SEE COLLECTED AS THE EVALUATION COMPONENT. THAT INCLUDES DIVERSITY OF THE PARTICIPANTS IN THESE EDUCATION ACTIVITIES AND DIVERSITY IN ALL AREAS TRAINING AND CAREER STAGE, EMPLOYMENT SECTOR GENDER RACE ETHNICITY INSTITUTION TYPE GEOGRAPHY WE WANT TO KNOW ADHERENCE OR DEGREE OF PARTICIPATION IN A COURSE, THAT WOULD BE IMPORTANT. FOR THEM TAKING THIS TO THE NEXT LEVEL AND UNDERSTANDING HOW PEOPLE ARE UTILIZING THIS KNOWLEDGE AND HOW DOES IT INFLUENCE THEIR RESEARCH OR CAREER GOALS GOING FORWARD. SO WHAT DO WE EXPECT AN OUTCOME FROM THIS EDUCATION PROGRAM? BROADEN EXPAND FOUNDATIONAL TRANSLATIONAL SCIENCE KNOWLEDGE. DOING THROUGH VARIETY OF ONLINE EDUCATION ACTIVITIES TO INCREASE UNDERSTANDING OF TRANSLATIONAL SCIENCE PRINCIPLES AND EFFECTIVE APPROACHES AND TRANSLATIONAL SCIENCE. WE KNOW ONLINE LEARNING ONLINE EDUCATION ACTIVITIES ARE HERE TO STAY, PEOPLE APPRECIATE THE FLEXIBILITY OF THIS, THEY APPRECIATE ACCESSIBILITY, SO WE WANT TO MAXIMIZE ONLINE LEARNING AND EVALUATE THIS TO LEAD TO EVIDENCE INFORMED TEACHING APPROACHES FOR ONLINE EDUCATION AND TRANSLATIONAL SCIENCE REACHING DIVERSE AUDIENCE OF LEARNERS. WE WANT TO CATALYZE NEW TRANSLATIONAL SCIENCE CURRICULA. SO ULTIMATELY THESE EDUCATION OPPORTUNITIES OR ACTIVITIES SHOWN TO BE EFFECTIVE COULD BE INFORM RATED INTO A WIDE RANGE OF BIOMEDICAL RESEARCH AND TRAINING, RESEARCH EDUCATION AND TRAINING PROGRAMS INCLUDING THOSE FUNDED BY NCATS BUT MORE BROADLY, ACROSS NIH. IN SUMMARY THIS PROPOSAL WILL ADVANCE TRANSLATIONAL SCIENCE EDUCATION FOR DEVELOPMENT IMPLEMENTATION AND EVALUATION OF ONLINE EDUCATION ACTIVITIES UNDERSTANDING TRANSLATIONAL SCIENCE PRINCIPLES AN APPLICATION TO RESEARCH ACROSS THE TRANSLATIONAL SCIENCE SPECTRUM. NOW IS THE TIME TO AGGREGATE THIS EXPERIENCIAL KNOWLEDGE WE AMASS AND WE HEARD ABOUT MANY OF THESE ADVANCES AT OUR TENTH ANNIVERSARY AND WE KNOW THERE ARE MORE THAN THAT TO DRAW ON. TIME TO EXPANDS TRANSLATIONAL SCIENCE KNOWLEDGE BASE AND CONDITION SRI TO BROAD RANGE OF INDIVIDUALS TO EXPAND AND DIVERSIFY THE WORK FORCE AND STIMULATE INNOVATION AND TRANSLATIONAL SCIENCE EDUCATION AND HOW WE ARE DEVELOPING THAT FORCE. ON THE NEXT SLIDE I WILL TRANSITION TO TAKING QUESTIONS AND COMMENTS FROM THE COUNCIL, COUNCIL MEMBERS WE LOOK FORWARD TO HEARING FROM YOU WHAT IMPROVE THE INITIATIVE AND OTHER THINGS WE SHOULD BE CONSIDERING. >> JESSICA, BEFORE YOU MOVE ON WE HAVE COUPLE OF COUNCIL MEMBERS DISCUSSANTS FOR THIS CONCEPT. I WILL LET BEBECKY GO FIRST AND RAJESH AFTER THAT AND HEAR YOUR THOUGHTS AND WE WILL OPEN FOR BROADER DISCUSSION. BECKY, LEAD US OFF? >> THANKS, JONI. I LIKE TO START THIS OFF BY SAYING THAT I'M INCREDIBLY ENTHUSIASTIC ABOUT SEEING REALLY LEVERAGE OF BROADER EXTRAMURAL COMMUNITY, THAT INCLUDES PUBLIC PRIVATE PARTNERSHIPS AND OTHERS THAT CAN PULL TOGETHER BOTH BASIC AS WELL AS MORE ADVANCE TRAINING IN THE UNDERLYING PRINCIPLES OF TRANSLATIONAL SCIENCE AND REALLY SHARING WITHIN THAT SOME OF THE TOOLS THAT WE CAN UTILIZE FOR DOING THAT. I DO THINK IT IS IMPORTANT SHOULD BE EMPHASIZED THAT THIS SHOULD REALLY SUPPORT THAT FULL SPECTRUM OF TRANSLATIONAL SCIENCE REALLY FROM TAKING DISCOVERY TO THE BEDSIDE ALL THE WAY INTO DISSEMINATION AND IMPLEMENTATION SCIENCE BUT THERE ARE COUPLE OF THINGS THAT I THINK COULD IMPROVE THIS I HAVE A COUPLE OF SUGGESTIONS TO RESPOND TO. THE FIRST I THINK IS THAT AS THE FIELD OF TRANSLATIONAL SCIENCE CONTINUES TO EXPAND AND AS WE GET MORE CLARITY AROUND SOME OF THE THINGS THAT WILL ADVANCE GOALS THAT HAD BEEN TALKED ABOUT TODAY I THINK THAT IS GOING TO BE CRITICAL THAT ANY TYPE OF ON LION OPPORTUNITIES ARE KEPT UP TO DAY SO HAVING THAT SUSTAINABILITSUSTAINABILITY PLAN REVIEW AN D UPDATE OF MATERIALS OR SUN DOWNING THEM AT SPECIFIC PERIODS OF TIME ARE CRITICAL IN ORDER FOR THIS TO ACTUALLY HAVE A SIGNIFICANT IMPACT. I THINK THE SECOND THING WHICH YOU MENTIONED IN YOUR SLIDE, REALLY TO INNOVATE CURRICULAR YOU KNOWVATION AND I USE THIS AS A OPPORTUNITY TO SEE WHICH APPROACHES ARE MOST EFFECTIVE FOR ADULT LEARNERS IN TERMS OF ACTUALLY CHANGING BEHAVIOR AND CULTURE AND BEING MORE ENGAGED AND TRANSLATIONAL SCIENCE APPROACHES. SO ONE OF THE PROBLEMS AS ALL OF US KNOW WHO CREATED ONLINE LEARNING, IS THAT IT DOES NOT FOLLOW THE FIELD OF DREAMS WHICH YOU TALKED ABOUT EARLIER SO JUST BECAUSE YOU BUILD IT DOESN'T MEAN PEOPLE WILL COME. IT IS IMPORTANT WE THINK ABOUT REALLY COMING UP WITH MORE ENGAGING APPROACHES, AND INNOVATIVE APPROACHES WHETHER THIS IMPLICATION CASE STUDIES, EXTENDED MORE IN DEPTH READINGS ASSOCIATED WITH THIS OR OTHER TYPES OF ACTIVITIES THAT COULD BE PURSUED THAT WILL TAKE THAT LEVEL FROM BASIC TO NEXT LEVEL MASTERY ALL THE WAY TO ADVANCE. ONE OF THE THINGS TO THINK ABOUT THIS IS YOU ALSO WANT TO SUPPORT OTHER ASSOCIATED ACTIVITIES. SO DISCUSSION FORMS PEOPLE WHO ARE INVOLVED IN THIS, OR WAYS OF STARTING TO DEVELOP A COMMUNITY OF PRACTICE OR WAYS TO FURTHER EXPAND THE FIELD. I THINK THE OTHER THINGS THEN IS TO THINK ABOUT HOW DO WE REALLY DRIVE SUCCESS OF THIS. I THINK IT WOULD BE WORTHWHILE IN THIS IS RATHER THAN ASKING OR HAVING A MEETING JUST BETWEEN THOSE THAT ARE FUNDED IS TO REALLY THINK ABOUT WHETHER IT MIGHT BE MORE NIMBLE COST EFFECTIVE AND GET YOU REALLY MORE SIGNIFICANT RESULTS IF YOU CONSIDER THIS AS MORE FORMALIZED CONSORTIA WHERE YOU BRING TOGETHER AND MAKE SOME LEVEL OF CONSISTENCY OF STRUCTURE. YOU CAN DO THIS THEN THROUGH PORTAL, DEVELOPMENT OF EDUCATIONAL ONTOLOGIES THAT ALLOW PEOPLE TO FIND BOTH CONTENT THAT BEST MET THEIR NEEDS AT THE TIME THEY HAD THEM AS WELL AS MARKETING AND COMMUNICATION PLANS THAT DRIVE TO THE RESOURCE AND CONSISTENT AND ACTIONABLE EVALUATION PLAN SO YOU ARE COMPARING ACROSS ALL THE DIFFERENT PROGRAMS THE SAME KIND OF EVALUATION IN TERMS OF LOOKING AT LONG TERM IMPACT. SO DOES THAT CHANGE LEVEL OF TRAJECTORY OR ENGAGEMENT OF RESEARCH TRANSLATION, ARE MOVING THE FIELD MORE RAPIDLY AND ARE WE BEING MORE EFFICIENT. I THINK IF YOU THINK ABOUT EXPANDING THIS PROGRAM BEYOND JUST THE SERIES OF ON LINE COURSES TO REALLY SERIES OF ONLINE ENGAGING ACTIVITIES, AND LEARNING BETWEEN DIFFERENT FUNDED PROGRAMS YOU WILL HAVE GREATER IMPACT ON THE TRANSLATIONAL SCIENCE WORK FORCE AND SIMILARLY CAN REALLY THEN FOCUS ON APPROACHES THAT ALSO ENHANCE DIVERSITY AND INCLUSION MULTIPLE PERSPECTIVES AS WELL AS INDIVIDUALS. >> THANK YOU, THOSE ARE ALL FANTASTIC COMMENTS, THINGS WE CAN REALLY TAKE TO HEART AS WE CRAFT MORE SPECIFIC LANGUAGE. I REALLY APPRECIATE YOUR POINT TO HAVE OUTCOMES WE NEED PEOPLE TO BE ENGAGED HOW DO WE ENHANCE THAT ENGAGEMENT. >> THANK YOU, RAJESH NEXT PLEASE. >> SURE. JESSICA I'M SORRY WE DIDN'T HAVE A CHANCE TO MEET EARLIER THIS WEEK YOU CAN CONNECT WITH ME A COUPLE OF TIMES. SO I DESIGN/I TEND TO SPEAK MY MIND SO I WILL HERE. I'M NOT ENTHUSIASTIC ABOUT THIS, TELL YOU WHY. DOES BECAUSE OF MY PAST EXPERIENCE HAVING TO DO THIS, I WAS HEAD OF EDUCATION OF NOVARTIS FOR SEVEN YEARS MULTI-NATIONAL COMPANY WE BASICALLY THE ORIGINAL IDEA WAS DO IT ALL ONLINE, YOU HAVE SEX CENTERS PUT IT ONLINE, WILL LEARN DRUG DISCOVERY AND EVERYTHING WILL BE HUNKY DORY, ADULTS DON'T LEARN THAT WAY. THIS IS -- THIS IS NOT THE MODEL BY WHICH YOU ARE GOING TO GET THE BIGGEST BANG FOR THE BUCK IN MY OPINION. THAT IS WHY THE COURSE IS SUCH AS THE ONES YOU DEVELOPED WHETHER THEY ARE ONLINE IN CLASSROOM SESSIONS SPEAKING WITH EXPERTS AND WHAT HAVE YOU REALLY CASE STUDY METHODOLOGY AND OTHER THINGS THAT MAKE A DIFFERENCE IS PREFERRED TO JUST PUTTING THAT OUT THERE BECAUSE IT IS TOO PASSIVE. THE OTHER CONCERN IS ONLINE COURSE IF YOU PUT THIS RFA OUT THERE OR WHATEVER APPROACH YOU TAKE CALL FOR APPLICATION MY CONCERN IS THE COMMUNITY WILL JUST DEVELOP A WHOLE BUNCH OF LECTURES, THEY WILL DO A SERIES, FIND A BUNCH OF PEOPLE WHO GIVE SERIES OF LECTURES ONE AFTER ANOTHER, PART ONCOLOGIST CLINICIAN TALK ABOUT SOMETHING AND THEN THAT WILL GET POSTED AS ONE AND THAT WILL GET POSTED AS OTHER. QUALITY CONTROL WILL VARY, THERE WON'T BE ANY STRUCTURE NORMALIZATION OF PRINCIPLES THAT WILL BE TAUGHT IN THERE. IT WILL BE A BOON TOGGLE, I'M JUST REALLY PRESENTING YOU THE OTHER CONCERN THAT I WOULD HAVE IN PUTTING THIS OUT THERE. YOU SHOULD THINK CAREFULLY ABOUT THIS IS WHERE YOU WANT TO INVEST YOUR RESOURCES IN THE EDUCATIONAL REALM,S WITH THE ONLINE ARENA. I I'M NOT -- I WILL THROW POSITIVES OUT THERE NOT JUST TO BE NEGATIVE. ONE THING THAT ACTUALLY WORK WHICH TOOK A LOT TO DEVELOP, OUT THERE AS FREE WARE, I KNOW A BRAZILIAN GROUP, THEY CALL THEIR GAME SCREENER, WE DEVELOP A GAME IN PHARMA, IN THE NOVARTIS CALLED PHARMA GAME OR SOMETHING LIKE THAT. FORGET HOW THEY BRANDED IT BUT YOU CAN DEVELOP A GAME WHICH IS WHETHER OUR TEENAGERS DO IS PLAY A GAME ALL THE TIME, PLAY A GAME AND LEARN DRUG DISCOVERY THAT MIGHT HAVE MORE IMPACT AND MIGHT BE A COOL WAY TO MEET APPROACH OF CURRENT GENERATION DRUG DISCOVERY. IF YOU CAN INCLUDE IT MIGHT BE INTERESTING TO SEE IF PROGRAMMERS OUT THERE CAN THINK ABOUT THE COMPLEXITY OF THE WIRING DIAGRAM IN LAST SLIDE MEANT TO HAPPEN FASTER AND TAKE THAT WIRING DIAGRAM AND FIGURE A WAY TO DO INPUT OUTPUT CIRCUIT GAIN YOU CAN THEN AS GROUP DECISION MAKING MAY TRICK. SO -- MATRIX. SO PK IS NOT GOOD. WHAT THE HELL DO YOU DO NEXT? THAT'S WHAT IT COSTS ANOTHER MILLION DOLLARS. DO YOU HAVE THE MONEY, YOU DON'T HAVE THE MONEY SO HOW DO YOU KNOW HUH WHOM TO EMPERIMENT. YOU COLLECT -- YOU DO A DIFFERENT EXPERIMENT TAKE HELO CELLS AND THAT DOESN'T WORK. WHAT IS NEXT EXPERIMENT? THAT MIGHT TEACH THEM MORE THAN A BUNCH OF DRY LECTURES THAT ESSENTIAL WILL I PUTTING TO ON A WEBSITE. SO THAT WOULD BE I WILL STOP WILL. TRILLION READING WHAT YOU SAY, I'M NOT SURE WHETHER THE COMMUNITY THAT IS GOING TO RESPOND TO THIS I HATE TO SAY WILL BE OUR GENERATION. OURS IS GOING TO (INAUDIBLE) SOMETHING NOT GOING TO WORK FOR THE NEXT GENERATION IN ONLINE SPACE. >> THANK YOU. ANYTHING TO RESPOND? WE WILL OPEN IT UP. >> I APPRECIATE THE COMMENTS AND I THINK THERE ARE MANY CAVEATS HERE AND THINGS TO THINK ABOUT. ONE OF THE THINGS SO HERE ARE SOME OF THE CHALLENGES THAT I SEE. ONE OF THE REASONS WE DID THE -- WE START WITH THE ONLINE COURSE WHICH AGAIN MAY -- IS VERY TRADITIONAL, I HOPE WE CAN DO THIS IN A LOT OF WAYS. WAS TO REACH MORE PEOPLE MORE UNDERGRADS AND THINK ABOUT THOSE SEGMENTS THAT AREN'T HEARING TRANSLATIONAL SIEBS OR MIGHT NOT BE AT A HUB IN A FORMAL TRAINING PROGRAM. SO REALLY THINKING HOW DO WE PUSH TRANSLATIONAL SCIENCE EDUCATION OUT WILL TO MORE PEOPLE AND EXPAND THE WORK FORCE AND DI VERY PHI WHO WE RECRUIT TO THE WORK FORCE. THAT IS ONE PRINCIPLE UNDERLYING THIS. IS GETTING TRANSLATIONAL SCIENCE EDUCATION TO MORE PEOPLE. I UNDERSTAND SOME OF THE CONCERNS YOU MAZE RAISE, WITHIN NIH WE HAVE DIFFERENT WAYS WE CAN DI SIGN FUND MECHANISMS WHERE THERE'S GREATER INVOLVEMENT FROM M CATS STAFF AND WE CAN HELP SHAPE THINGS LITTLE MORE AS DR. JACKSON SAID THROUGH CONSORTIUM PROCESS AND SETTING CENTRALIZED EVALUATION MATRIX -- MEASURES AND BEING ABLE TO HAVE THAT SORT OF I DON'T KNOW IF I WANT TO USE OVERSIGHT BUT MORE CENTRALIZED FUNCTION ACROSS ALL THESE ACTIVITIES. WE COULD HELP SHAPE THAT AS WELL. SO I UNDERSTAND WHAT YOU ARE SAYING. (OVERLAPPING SPEAKERS) >> THIS MAY NOT FIT INTO YOUR SCHEME OF THINGS. SEND THIS OUT AS THINGS FOR HIGH SCHOOL STUDENTS AND COLLEGE STUDENTS TO BUILD RATHER THAN YOUR PI IN SOME UNIVERSITY AND THEN GIVE HEM THE EXPERTISE THEY NEED TO LEARN BUT THEY CAN BUILD WHAT NEEDS TO BE BUILT TO HELP PEERS LEARN. I THINK WHAT WE NEED IN THIS SITUATION IS SOME THOUGHTFUL EXPERTISE IN EDUCATIONAL METHODOLOGY THAT WORKS FOR THE GENERATION THAT WE ARE TRYING TO TEACH. NOT THE SAME YOU AND I LEARNED. WE MAKE THIS MISTAKE ALL THE TIME, IF WE TAKE IT THE WAY WE LEARN IT THEY WILL LEARN IT. I DON'T THINK THAT WORKS. >> GOOD POINT. GO I A HEAD. >> IT IS CLEARLY A SIGNIFICANT UNMET NEED THERE IS A FAIR ENOUGH ACTIVITY IN THE SPACE WHICH IF YOU CAN REACH INTO CONCEPT OF ONTOLOGY, FRAMEWORK WHAT HAS BEEN DEVELOPED INCLUDING IN OUR FORM OF TRAINING CERTIFICATE WHERE TRANSLATIONAL ELEMENTS ARE TAUGHT, THEIR DISEASE SPACE BUT MIGHT BE GENERALLY APPLICABLE IN SEVERAL CTSA SITES, TRANSLATION TRAINING PROGRAMS ONLINE SO THEN I THINK WOULD BE DELIVERABLE WHICH WOULD HAVE IMMEDIATE IMPACT EXTENDING ON RAJESH CONCEPT, WE ARE DEVELOPING COMPETITION FOR SPECIFIC NEEDS TO SOFTWARE DEVELOPMENT FOR MOLECULAR BIOLOGY DATA MINING TOOLS. THIS COULD BE ADOPTED AS WELL DEFINE EDUCATIONAL PROBLEM AND YOU LET COMPETITION COMPETE LARGE COMMUNITY OF DIVERSE STAKEHOLDERS AND THEN YOU HAVE A BENCHMARKING PROCESS AND THAT IS A KEY PIECE TO DEVELOP INNOVATIVE CREATIVE EFFECTIVE BENCHMARK,OBVIOUSLY THE COUNTER COMPETITIONS BUT MIGHT BE A WAY TO PULL IN UNEXPECTED IN A WAY THAT YOU ARE NOT CONSTRAINING TO ONLY ONE OR TWO BUT YOU GET WIDE SPECTRUM OF SOLUTIONS, YOU CAN SET UP COMPETITION THAT YOU HAVE STAGGERED RESOURCE DISTRIBUTION TO MAIN PERFORMANCE. WHICH IS OUT AND COULD BE ENGAGED. VERY YOUNG COMPETITORS ENTERING THESE SPACE AND SOMETIMES THEY ARE NOT TRAINING LEADING EDGE. >> YOU MADE COMMENTS IN CHAT. SAY ANYTHING MOTHER? >> I THINK WHAT YOU DESCRIBE THE GOAL OF PROFESSIONALIZING TRANSLATIONAL SCIENCE AS A DOMAIN OF EXPERTISE IS NECESSARY. IF IF GOAL IS TO REACH YOUNGER GENERATION I AGREE WITH RAGESH DO AN EXPERIMENT ON THE SIDE AND GUILTY IT BUT IF YOU ARE GOING TO GAMEFY IT DON'T DO IT IN A WEB 2.0, GO ALL THE WAY. GO ALL IN AND DO IT IN A WEB 3.0 ENVIRONMENT THEN REACH THE WORLD. >> MAKE IT VR. >> AGAIN, I DON'T WANT TO TAKE UP ALL THE REST OF THE TIME, IT IS LIKE I WAS JUST TEXTING BECAUSE I WAS GETTING REALLY INTO IT BECAUSE I'M INTO THIS SORT OF THING AND WE BUILD THIS STUFF. SO IT JUST HIT A NERVE IF THE GOAL IS THE YOUNGER GENERATION, I THINK IT IS WORTH THINKING CONTENT DELIVERY IN NEW WAY BUT YOU HAVE BEEN SO THOUGHTFUL WHAT THAT CONTENT IS. IT WAS JUST WRAPPING. >> I WOULD SECOND KELLY, I THINK THE CONTENT IS NOT THE ISSUE. IT WAS REALLY ABOUT HOW YOU WANT TO GET THIS ACROSS. WHO YOUR AUDIENCE IS. IF YOUR AUDIENCE IS 30 SOMETHINGs AND BELOW WHO YOU ARE WANTING TO BE THE NEXT GENERATION HAVE GROWN UP DIFFERENTLY THAN WE HAVE. >> RIGHT. YOU DID COME ACROSS AS SOUNDING LIKE A LITTLE BIT LIKE YOU WERE CRITICIZING THE CONTEMPT. JUST MY OPINION. IT IS GOOD YOU CLARIFIED THAT YOU DIDN'T MEAN THAT. >> GOOD. THANK YOU. KEITH I SEE YOUR HAND THEN WE WILL LET BECK KY HAVE THE LAST WORD HERE. KEITH GO AHEAD. >> I THINK YOU ARE MUTED. >> YOU ARE ON MUTE STILL. >> THANK YOU. I'M INTRIGUED BY THE VALUATION COMPONENT AND ESPECIALLY INTERESTED IN BEING SURE WE WILL LEARN HOW TO REACH DIFFERENT AUDIENCES DIFFERENTLY, I DON'T MEAN THE YOUTH AUDIENT. THAT IS MADE ALREADY. I'M THINKING IN TERMS OF DIVERSITY, IT IS A CHALLENGE FOR ME AS AN STROBING TORR EVEN IN A LIVE ENVIRONMENT TO THINK HOW DID I SAY THAT AND DID I SAY IN A WAY THAT RESONATES WITH DIVERSE AUDIENCE BY RACE ETHNICITY AGE, ET CETERA. RATHER THAN JUST GETTING BACK COUNTS OF WHO AND WHAT TYPES OF PEOPLE WENT THROUGH WHETHER GETTING BACK GENERAL IMPRESSIONS I WOULD LOVE TO SEE INNOVATION. HOW DO WE LEARN HOW TO TAILOR OUR PEDAGOGUE NO MATTER WHAT IT IS TOWARD THE DIFFERENT AUDIENCES. AND FINALLY VERY USE -- THEIR USE OF THAT IN THEIR TRANSLATIONAL WORK AS THEY REACH OUT, TO A MORE DIVERSE AUDIENCE. >> WELL TAKEN. THANK YOU. BECKY. >> IT SOUNDS LIKE THERE IS A CONSENSUS AMONG ALL OF US THAT TRADITIONAL LECTURE WITH POWERPOINT SLIDES, PROBABLY AN INEFFECTIVE STRATEGY FOR CERTAINLY CAN BE BACKGROUND MATERIAL BUT IT CLEARLY ISN'T THE MOST EFFECTIVE WAY I THINK IF YOU REALLY EXPAND THIS TO THINK OF HOW CAN WE USE OTHER ONLINE THAT INCLUDES LOTS OF DIFFERENT APPROACH AND THINK HOW THAT ACTUALLY BRINGS ACROSS PROCESS GUILTYCATION SOMETHING WE USE A LOT OF. SOUNDS LIKE YOU DO TOO. IT IS SIMPLY MORE ENGAGING BUT BRINGING TOGETHER IN A WAY THAT YOU HAVE MORE INTEGRATED SYSTEM AND THEN THE WAY TO BE ABLE TO SEARCH WHAT YOU NEED AT THE TIME YOU NEED IT. WOULD ADVANCE ALONG AS YOU MAKE IT AN AVAILABLE SOURCE. >> THANK YOU FOR THAT. ANY FINAL THOUGHTS HERE TO RELAY? >> THIS IS HELPFUL I'M EXCITED TO HEAR THE THEWS AM AROUND THE CONTENT PIECE AND SOUNDS LIKE THE OTHER SUGGESTIONS GO FURTHER AS FAR AS FOSTERING MORE CREATIVE APPROACH HERE. THAT WOULD BE EXCITING FORWARD THING FOR NCATS TO DO LIKE ALWAYS. >> THANK YOU SO MUCH. WE HAVE A LOT TO THINK ABOUT. WBEWILL MOVE TO THE NEXT CONCEPT CLEARANCE, PRESENTATION. >> WE NEED TO VOTE. >> NO FURTHER DISCUSSION. MOTION TO ADVANCE CONCEPT WITH THEIR COMMENTS UNDER ADVISE. >> SO MOVED. >> SECOND? >> SECOND. >> ALL IN FAVOR >> AYE. AYE. AYE. >> ANY ABSTENTIONS? NEXT CONCEPT PLEASE. >> I WANT THE MAKE SURE YOU GOT THE ONE EXTENSION THERE. DID YOU GET IT, ANNA? >> I ABSTAINED BUT I WAS ON MUTE. >> GOT IT. WANT TO MAKE SURE. >> WE WILL GO AHEAD AND MOVE TO THE NEXT CONCEPT CLEARANCE. THIS IS WITH OFFICE OF SPECIAL INITIATIVES. I WILL TURN IT OVER TO DAN TAGLE. PLEASE TAKE IT AWAY. >> THANK YOU, GOOD AFTERNOON EVERYONE, THANK YOU FOR HANGING IN FOR THE LAST PRESENTATION OF THE DAY. I'M DAN TAGLE, DIRECTOR OF OFFICE OF SPECIAL INITIATIVES HERE TO GIVE A BACKGROUND ABOUT THE OFFICE AS WELL AS SOME BACKGROUND ABOUT THE INITIATIVE. NEXT SLIDE PLEASE. BRIEFLY AGAIN, I MENTIONED IN CLOSE SESSION THE MISSION OF OFFICE OF SPECIAL INITIATIVES IS REALLY TO DEVELOP INNOVATIVE SOLUTIONS THROUGH DISRUPTIVE TECHNOLOGY AND OTHER PARTNERSHIPS IN ORDER THE ADDRESS THE MAJOR TRANSLATIONAL PROBLEMS THAT THAT PERVADE IN THE FIELD. SO THIS IS A LISTING OF PROGRAMS AND ACTIVITIES WITHIN OFFICE OF SPECIAL INITIATIVES. SO THE CONCEPT THAT IS UP FOR YOUR DISCUSSION AND CONCURRENCE IS THE -- SO THAT EXTREME STANDS FOR EXOSOME BASED THERAPIES FOR REGENERATIVE MEDICINE, THIS WILL BE A NEW INITIATIVE WITHIN THE OFFICE BUT I WANT TO MEMBERS OF THEY JURY IT LEVERAGES PREVIOUS INVESTMENTS FROM THE NIH COMMON FUND. EXTRA CELLULAR RNA COMMUNICATION INDICATED IN ONE BULLET ABOVE WHICH LOOKS AT SECRETED RNA PRIMARILY FOR BIOMARKER THERAPY DEVELOPMENT. SO THERE IS FROM COMMON FUND IN TERMS OF TOOLS AND RESOURCES DEVELOPED IN ORDER TO ISOLATE EXOSOMES. SO NEXT SLIDE. WHAT ARE EXSOME? THEY HAVE BEEN RECOGNIZED AS AN ARTIFACT OR PERHAPS CELL DEBRIS, IT HAS ONLY BEEN RECOGNIZED WITHIN THE LAST DECADE OR SO THAT IT ACTUALLY CARRIES FORTH AN IMPORTANT FUNCTION WITHIN THE BODY. THAT FUNCTION IS NOVEL MESSENGER FOR INTERCELLULAR COMMUNICATION. EXOSOMES ARE ESSENTIALLY DIFFERENT SHADED FROM OTHER MICROVESICAL MS. THE SENSE MICROVESICALS FROM PLASMA MEMBRANE WHEREAS ENDOSOMES ARE RELEASED TO THE EXTRA CELLULAR MATRIX WHEN VESICULAR BODIES FUSE WITH CELL MEMBRANE SO ENDOSOMAL ORIGIN. THEY ARE PRETTY SMALL ORGANELLES THEY ARE ABOUT 40 TO 150 NANOMETERS. AND CARRY IMPORTANT BIOACTIVE MOLECULES WHICH ARE IMPORTANT FOR SIGNALING AS WELL AS FOR OTHER CELLULAR FUNCTION. SO THIS BIOACTIVE CARGO INCLUDES LIPIDS PROTEINS, MESSENGER RNA AND IMPORTANTLY ALSO REGULATORY RNA SUCH AS MICRORNA AND LONG NON-CODING RNAs. THESE EXSOMES CONTAIN SURFACE PROTEINS, ALLOWING IT TO TARGET TO SPECIFIC CELL TYPES TO ALLOW SPECIFIC COMMUNICATION BETWEEN DIFFERENT CELLS. AND DIFFERENT MILIEU. I THINK WE HEARD FROM TARA SCHWETZ EARLIER ABOUT ARPA H AND WANT OF THE INTERESTS IN MOLECULAR ZIP CODES, WE HAVE EXOSOMES THAT ARE NOT POPULATED WITH CELL SPECIFIC OR TISSUE SPECIFIC MOLECULAR ZIP CODES THAT ALLOW TO ZOOM IN WITH SPECIFIC TARGETS. IT HAS BEEN RECOGNIZED IMPORTANT AS INTRACELLULAR SIGNALING MOLECULES EXSOMES CAN BE USED TO REPAIR TISSUE INHERENTLY IN ITS OWN OR BECAUSE YOU CAN ACTUALLY MANIPULATE NOT ONLY SURFACE MARKERS BUT ALSO MANIPULATE CARGO, YOU CAN LOAD UP WITH VARIOUS THERAPEUTIC CARGOES SUCH AS PROTEINS, GENE THERAPIES AN VACCINES TO ALLOW SPECIFIC TARGETING WITH MINIMIZING ANY UNDUE EFFECTS IN THE TISSUE. MENTION SLIDE. NEXT SLIDE. THIS IS A IN U CONCEPT CLEARANCE, IT SAYS EXOSOME THERAPEUTICS FOR REGENERATIVE MEDICINE, DR. HAPPEL WILL DO THE PRESENTATION. SO SHE HAS A Ph.D. IN GENETICS FROM THEM IT WILL UNIVERSITY SCHOOL OF MEDICINE, SHE RECEIVED THE RUTH KIRSTEIN POST-DOCTORAL FELLOWSHIP AT HOPKINS WORKING ON MICRORNA REGULATION AS WELL AS DOING SECOND POST-DOC AT NCI. SO CHRISTINE WILL BE TALKING A LITTLE BIT MORE IN DETAIL ABOUT THIS CONCEPT CLEARANCE. SO I WILL TURN IT TO YOU, CHRISTINE. >> THANK YOU. THIS IS A NEW CONCEPT THAT WE ARE PROPOSING FOR NICELY NAMED EXTREME. NEXT SLIDE PLEASE. DESPITE SUCCESS IN REGENERATIVE MEDICINE MAJOR CHALLENGES ARE MAIN IN THE FIELD. STEM CELL TRANSPLANTATION CURRENTLY MAIN METHOD FOR TISSUE REGENERATION PROGRESS IS LIMITED HURDLES INCLUDE RELIABLE CELL SOURCE TUMOR FORMATION, INAPPROPRIATE STEM CELL MIGRATION, IMMUNE REJECTION OF TRANSPLANTED STEM CELLS, COMPLICATIONS DURING SURGERY AND POST-OPERATIVE INFECTION. WITH THIS CONCEPT NCATS PROPOSES A NOVEL EXSOME BASED THERAPEUTICS PROGRAM TO CATALYZE REGENERATIVE MEDICINE CREATING A THERAPEUTIC SO AS SEEN ON THE SCHEMATIC ON THE RIGHT EXOSOMES ARE SMALL ENDOGENOUS MEMBRANE ENCLOSED CARRIERS. ABOUT THE SIZE OF VIRUS PARTICLE. AND AS DAN SAID THEY CONTAIN BIOACTIVE PROTEIN LIPIDS AND NUCLEIC ACIDS, FOR INTRACELLULAR COMMUNICATION. EXOSOME BASED COMMUNICATION OCCURS IN A BIDIRECTIONAL MANNER AND TAKE PLACE DURING NORMAL CELL HOMEOSTASIS AND CONSEQUENCE OF PATHOLOGICAL DEVELOPMENT. SO THE SCHEMATIC SHOWN HERE SHOWS SIGNALING BETWEEN DISEASE CELL AND STEM CELL WHERE DISEASE CELL IS INDICATING DISTRESS. THE STEM CELL THEN RESPONDS BY RELEASING SPECIFIC REPAIR EXSOMES. WHAT MAKES THIS CONCEPT PARADIGM SHIFT IS THAT UTILIZES NON-LIVING CELLULAR PRODUCT RATHER THAN STEM CELLS THEMSELVES TO PROMOTE TISSUE REGENERATION. THERAPIES TO PROMOTE TISSUE REPAIR A WOUND HEALING TRANSLATED TO THE CLINIC. EXTREME KNOWLEDGE RESOURCES DEVELOPED BY COMMON FUND EXTRA CELLULAR RNA COMMUNICATION PROGRAM WHICH LOOK AT EXTRA CELLULAR RNA CARRIERS SUCH AS EXSOMES, AS CRITICAL MEDIATORS OF INTRACELLULAR COMMUNICATION. ALSO BUILD OFF RECENTLY CONCLUDED COMMON FUND REGENERATIVE MEDICINE PROGRAM, AND LEVERAGE EXPERTISE OF NCATS STEM CELL TRANSLATION LABORATORY. NEXT SLIDE. SO THE OBJECTIVE OF THIS PROGRAM IS TRANSFORM REGENERATIVE MEDICINE THROUGH NOVEL EXOSOME BASED THERAPEUTIC AND TISSUE REPAIR WOUND HEALING. AS SOON IN THE SCHEMATIC ON THE RIGHT THERE ARE TWO WAYS THIS CAN BE ACHIEVED. THE PERSON HAS DIRECT EXOSOME THERAPY WHICH UTILIZES EXOSOMES ISOLATED STEM CELLS STORED AS OFFICE THERAPY TO BE INFUSED IN PATIENTS. SO AN EXAMPLE OF DIRECT EXOSOME THERAPY, WE FOUND RECENT PUBLICATION WHERE THEY DEMONSTRATED ENDOTHELIAL CELL DERIVED EXOSOMES WERE ABLE TO INDUCE CARDIAC TISSUE REPAIR, FOLLOWING ISCHEMIC REPROFUSION INJURY BY SUPPLEMENTING NEARBY CELLS BY PROTEINS WITH CRITICAL CELLULAR PROCESSES. THE SECOND WAY THIS CAN BE ACHIEVE IS THROUGH DESIGN EVERYBODY EXOSOMES WHICH IS PERSONALIZED ACCORDING TO INDIVIDUAL PATIENT NEEDS. THIS MEANS STEM CELL CELLS ARE HARVESTED FROM PATIENT EXPANDED AND MODIFIED BASED ON NEEDS FOLLOWED BY GENERATION OF EXOSOMES THAT ARE INFUSED BACK INTO THE SAME PATIENT. MODIFICATIONS INCLUDE GENETIC MODIFICATION, ADDITION OF THERAPEUTIC SMALL MOLECULES OR CELL SURFACE RECEPTORS FOR SPECIFIC EXOSOME TARGETING. WE ANTICIPATE EXTREME ENCOMPASS KEY AREAS OF EXOSOME THERAPEUTICS. DIRECT EXOSOME THERAPY, WOULD BE MORMORE ACHIEVEABLE, DESIGNER EXOSOMES PUSH ENVELOPE IN WHAT CAN BE ACHIEVED. IMPLEMENTATION OF THIS CONCEPT INCLUDES FOCUS ON IND ENABLING THERAPEUTICS AND ENTAIL EARLY ENGAGEMENT WITH THE FDA TOWARD REGULATORY APPROVAL. UTILIZE A MILESTONE DRIVEN APPROACH TOWARD THESE THERAPEUTICS TRANSLATED TO CLINIC, A CONSORTIUM OF FUNDED INVESTIGATORS TO FACILITATE SHARING RESOURCES AND EXPERTISE. METRICS INCLUDE DEMONSTRATION OF ABILITY TO REGENERATE DISEASE ORGANS, FROM MANY HUMAN DISORDERS AND THE VALIDATION OF THESE THERAPEUTICS BENEFITS IN VIVO OR EXVIVO. SO THIS WOULD INCLUDE A KNOWLEDGE OF SPECIFIC STEM CELL DERIVED EXOSOME TO ENDEUCE REPAIR AND WOUND HEALING AT SPECIFIC TARGET ORGANS. FINALLY WE EXPECT THAT THE RESEARCH ACTIVITIES AND RESULTS SPUR NUMBER OF COMMERCIAL ACTIVITIES BEYOND INITIAL NCATS INVESTMENTMENINVESTMENT. NEXT SLIDE. IN SUMMARY, EXOSOMES REPRESENT THE THERAPY DUE TO NATURAL FUNCTION AS MEDIATORS OF TISSUE REPAIR AND WOUND HAILING. NCATS PROPOSES THIS CONCEPT TO TRANSFORM REGENERATIVE MEDICINE APPROACHES THROUGH THESE NOVEL EXOSOME BASED THERAPEUTICS, CREATING A BUT THERAPEUTIC PARADIGM. THIS CONCEPT WOULD DEVELOP CELL DERIVED HE CANSOME BASED THERAPEUTICS FOR REGULATORY APPROVAL AND TRANSLATION INTO THE CLINIC TO THE BENEFIT OF PATIENTS. WITH THAT WE WILL BRING UP OUR QUESTIONS FOR COUNCIL FOR DISCUSSION. THANK YOU. T >> WE HAVE A COUPLE OF DISCUSSANTS. ANNIE WOULD YOU LIKE TO GO FIRST? >> I DON'T KNOW THAT I CAN COMMENT ON THE SCIENCE ITSELF THAT WAS DESCRIBED BUT I THINK ONE OF THE THINGS AS I WAS READING THIS PROPOSAL OVER THE WEEKEND STRUCK BY WAS FIRST I APPRECIATE THE INNOVATION NATURE OF PERSONALIZED MEDICINE. ONE OF THE THINGS THAT WE TALKED ABOUT HERE ALREADY TODAY WE TALKED ABOUT PREVIOUSLY, WAS AS YOU ARTICULATED THE METRICS DEMONSTRATION ABILITY TO REPAIR DISEASED ORGANS FROM HUMAN DISORDERS AND VALIDATION OF THERAPEUTIC BENEFITS. AND I JUST WONDERING IF SPECIFIC TO THIS PROJECT AND PROGRAM IF WE SHOULDN'T BE THINKING ABOUT NCATS CHARGE AS BEING BEYOND JUST REGULATORY APPROVAL AT THE FDA? BUT THINKING ABOUT DECISIONS NOW HAPPENING WITHIN CMS. AND HOW IF YOU THINK ABOUT CONSORTIUM YOU BRING TOGETHER STAKEHOLDERS AND BUILDING ON THE PARADIGM YOU ARE THINKING ABOUT WHAT THE IMPLICATIONS FOR THIS WILL BE WITHIN THE ENVIRONMENT, HOW -- WHAT OUTCOMES YOU ARE LOOKING FOR AS YOU STRUCTURE THIS TO SHOW THAT BENEFITS IN VIVO EXVIVO ARE BETTER THAN WHAT IS AVAILABLE NOW REIMBURSED SUCH. SO JUST SOME THINGS FOR CONSIDERATION AS YOU ARE BUILDING OUT THE SCOPE OF THIS AND WE ARE THINKING WHICH PARTNER SO THAT WOULD BE DEPENDENT WHICH DISEASE COMMUNITIES WHETHER YOU ARE THINKING ABOUT MEDICARE STRUCTURE OR MEDICAID STRUCTURE, OR MORE COMMERCIAL ENTITIES. SO JUST SOMETHING TO THINK ABOUT MORE BROADLY. AND THEN OBVIOUSLY DATA SHARING COMPONENTS WHICH WE ALSO TALK ABOUT WOULD BE INCREDIBLY IMPORTANT TO CONSIDER. THOSE WERE MY ONLY COMMENTS ALSO EXTEND MORE BROADLY TO OTHER PROGRAMS WE ARE CONSIDERING AS WELL. WE ARE THINKING ABOUT ACCESS NOW. NEVER TOO EARLY. WE ARE THINKING ABOUT PROGRAM AND HA IS A FANTASTIC WAY TO KEEP OUR EYE ON THAT BALL. I APPRECIATE THAT COMMENT. >> VERY INSIGHTFUL QUESTIONS AND THINGS WE WILL KEEP IN MIND AS WE MOVE FORWARD. THEY ARE VERY IMPORTANT BIG PICTURE SUGGESTIONS, THANK YOU, THAT'S HELPFUL. >> KRISTINA, I THINK I CAN COMPLIMENT THIS I WILL BE A LITTLE MORE ON THE TAKING A MOLECULAR BIOLOGY ASPECT. I THINK VERY HIGHLY, RNA CONSORTIUM HAS DONE A TREMENDOUS JOB IN DEFINING ALL THE METHOD LOGICAL CONSTRAINT IN THAT SPACE, AND ASSETS LEVERAGE -- OBVIOUSLY WE HAVE SEEN SPECIFIC SUCCESSES WITH THESE TYPE OF INTERVENTIONS, FROM BASIC SCIENCE APPROACH, MY CONCERN STRATEGIES THAT IT IS BLACK BOX APPROACH. YOU TRANSFER BIOLOGICAL ACTIVITY WITHOUT CHARACTERIZATION OF BIOLOGICAL ACTIVITY INTO VARIOUS DISEASE SETTINGS. AND WHY THIS APPROACH CAN BE SUCCESSFUL A NEPHROLOGIST WHO HAS DONEPHORESES TREATMENTS AND STUDIES, IT REMAINS BLACK BOX. YOU WILL HAVE RESPONDERS AND NON-RESPONDERS AND IT WILL BE DIFFICULT OR IMPOSSIBLE TO DEFINE WHO IS RESPONDING AND FOR WHAT REASON. THE SCIENCE HAS MOVED FORWARD AS WE DISCUSSED EARLIER WE HAVE NOW AN OPPORTUNITY TO ACTUALLY KNOW THE BAR CODES, YOUR VESICLES ARE HEADING TOWARDS. YOU CAN SELECT AND DESIGN YOUR VESICALES, YOUR VESICLE SORT AND TYPE GETS PREDEFINED AND CONTENTS CAN BE DEFINED AS WELL. WHILE THIS MIGHT BE NOT IN SCOPE OF THE SPECIFIC OPPORTUNITY I AT LEAST WOULD DESIGN OPPORTUNITY SUCH THAT THIS MORE TARGETED APPROACH CAN BE DEVELOPED OUT OF CLINICAL IMPLEMENTATION STRATEGY SO WILL IS A AN ARM BUILT IN WHEN THE VESICALES ARE TRANSFERRED AND DEFINED RESPONSES WHICH THE TECHNOLOGIES I THINK ARE THERE NOW BASED ON O CONSORTIUM EFFORT YOU CAN DAPTURE WHO IS RESPONDING AND WHAT VESICAL -- CAPTURE WHO RESPONDING AND WHAT VESICLE RESPONDS TO MENTION STAGE TOWARDS MOLECULAR DEFINED INTERVENTIONS. OBVIOUSLY VESICALLY TARGETING TRANSCRIPTS WE HAVE SOME OF THOSE INTO OUR SHOULDERS RECENTLY. AND THEY HAVE BEEN MAJOR BREAK THROUGH AND FULL DISCLOSURE WE ARE WRITING WITH SUCH ENTITIES TO TARGET VESICALES TOWARDS SPECIFIC CELLS AND SPECIFIC DISEASES. SO IN A SINGLE MOLECULE DEFINE APPROACH ALREADY MOVING FORWARD BUT YOU STRATEGY MIGHT BE INTERMEDIATE SPACE WHERE YOU CAN UNDERSTAND WHERE BIOLOGY LEVERAGING PRINCIPLE TO COMMENT TOWARDS MOLECULAR CHEMICALLY DEFINED APPROACH. SO CERTAINLY MOVE FORWARD. BUT TRY TO BUILD DISCOVERY COMPONENT IN TO THE TRANSLATIONAL ASPECT INCENTIVIZING. >> THANK YOU FOR THOSE COMMENTS. CHRISTINE. DO YOU WANT TO -- >> YEAH. THANK YOU FOR THOSE COMMENTS. I THINK YOU ARE CERTAINLY RIGHT IN THAT RIGHT NOW THESE -- PEOPLE ARE STARTING TO GET TO THIS AREA AND RIGHT NOW IT IS A LITTLE BIT LIKE BLACK BOX BUT THAT IS WHY I THINK NCATS IS SO WELL-POSITIONED TO DIVE IN AND MAKE SIGNIFICANT IMPROVEMENTS. BECAUSE WE ARE LEVERAGING A LOT OF VERY NEW TECHNOLOGIES THAT HAVE BEEN DEVELOPED. SO THE M CATS STEM CELL LABORATORY THEY ARE WELL -- VERY WELL EXPERIENCED IN STEM CELL ISOLATION. SO WE CAN UTILIZE THEIR EXPERTISE TO GENERATE WELL CHARACTERIZED SOURCES OF THESE STEM CELL EXOSOMES AND UTILIZE KNOWLEDGE FROM EXTRA CELLULAR RNA COMMUNICATION PROGRAM AN EXOSOME LYSE ICE LAKES METHODS THEY DEVELOPED, TO REALLY CONTRIBUTE TO MAKING SOME VERY WELL CHARACTERIZED EXOSOME SOURCES BY PIECING ALL THESE DIFFERENT TECHNOLOGIES THAT HAVE BEEN DEVELOPED SO UTILIZING THE PRODUCTION OF WELL CHARACTERIZED STEM CELLS FROM A STEM CELLS TRANSLATION LABORATORY UTILIZING EXOSOME ISOLATION TECHNOLOGY FROM EXC CELLULAR COMMUNICATION PROGRAM AND ALSO SOME OF THE RESOURCES FROM THE REGENERATIVE MEDICINE SONOR CONSORTIUM SO IT IS THIS WHEN YOU FIT PIECES TOGETHER I THINK REALLY EVERYTHING IS THERE TO HELP A MAKE LESS A BLACK BOX AND MORE WELL DEFINED. EXACTLY WHAT THE MECHANISM ACTION IS FOR THESE EXOSOMAL THERAPIES SO WE UNDERSTAND EXACTLY WHAT IS TAKING PLACE AND WHAT IS DERIVING THE THERAPEUTIC EFFECTS. >> IF YOU MAKE SURE THE ACTIVITY IS NOT ONLY LOOKING AT CLINICAL EFFICACY BUT ALSO BUILT IN SPECIFIC AIMS TOWARD TO BUY GENERATING EFFICACY SIGNALS ALSO ALLOWING TO UNDERSTAND WHICH MOLECULAR COMPONENT EFFICACY IS TARGETING TO. THAT IS MY MAIN COMMENT. >> GREAT COMMENT. THANK YOU. SO >> SO WE WILL OPEN FOR DISCUSSION. I SEE MARSHALL AND RAGESH. >> ONE OF MY COLLEAGUES IS DOING WORK IN THIS. WHAT IS IT ACTUALLY DOING? IT GETS HAND WAVING QUICKLY. WHAT ARE THE COMPONENTS HAVING THERAPEUTIC EFFECT? WE DON'T KNOW. THERE'S SOMETHING THERE AND THINGS LIKE THAT ONE THING I MIGHT SUGGEST ANYWAY, IS THINK ABOUT PARTNERING WITH ANOTHER INSTITUTE WHETHER NSF OR SOMEBODY ELSE, WHO THE DO THE BASIC SCIENCE ON THIS. YOU WILL HAVE WELL CHARACTERIZED EXOSOMES FROM WELL CHARACTERIZED STEM CELLS, THAT DOESN'T MEAN YOU KNOW WHAT IS IN THEM. AND WHICH HAVING BIOACTIVE PROPERTIES. SO WHEN WE WERE DOING PEOPLE TRANSPLANTS, TAKING ONE TO THE OTHER PATIENTS WERE SEEING IMPROVEMENT, I DIDN'T DO THOSE IN GENETICS. WHEN YOU ASKED WHAT IT WAS TRANSPLANTED NO ONE KNEW WHAT IT WAS. YOU ARE IN A MUCH BETTER POSITION BUTTONLY RECOMMEND PARTNERSHIP WITH TO GET A GOOD ABASIC SCIENCE COMPONENT OF THIS. >> SO PEOPLE DON'T THINK I WOKE UP ON THE WRONG SIDE OF THE BED, I DO LIKE THIS PROPOSAL AND WANTED TO SAY SO. >> THANK YOU, RAJESH. I CAN JUMP IN, I THINK THAT THE ISOLATION TOOLS OF EXTRA CELLULAR RNA COMMUNICATION PROGRAM HAS DEVELOPED AS WELL AS THE ANALYTICAL TOOLS. I THINK ARE REALLY GOING TO BE ABLE TO ADDRESS A LOT OF THE BASIC CONCERNS ABOUT MECHANISM OF ACTION BECAUSE HISTORICALLY HE IS SMALL VESICALES ARE DIFFICULT TO PURIFY. BUT SOME OF THESE TECHNOLOGIES A LOT ARE MICROFLUIDIC BASED OR -- THERE'S A LOT OF DIFFERENT TECHNOLOGIES BUILT THROUGH THIS PROGRAM. THEN USING THESE TOOLS WILL HAVE MUCH MORE HOMOGENOUS PRODUCTION OF THESE EXOSOMES THAT ARE MORE WELL CHARACTERIZED. SO I THINK THAT WILL GO A LONG WAY INTO REALLY ANSWERING A LOT OF THOSE QUESTIONS MANY TERMS OF MECHANISM OF ACTION AND WHAT IS REALLY RESULTING THIS IN THERAPEUTIC EFFECT. >> YOU WILL HAVE A PURE SOURCE DEEP DIVING EVERYTHING -- EVEN IF SMALL MOLECULES, DOESN'T HAVE TO BE BIOLOGIC. GOD KNOWS WHAT IS IN THESE THINGS. >> EXACTLY. ANALYTICAL TOOLS THAT GO WITH THESE ISOLATION TECHNOLOGIES, SHOULD REALLY ALLOW US TO PINPOINT THE EXACT CARGO RESPONSIBLE FOR THESE ACTIVITIES. SO I'M CONFIDENT THAT THE NEW TECHNOLOGIES WHICH I KNOW ARE LOT OF THESE TECHNOLOGIES ARE JUST GETTING TO THE POINT WHERE BEING PUBLISHED, BUT I THINK THEY ARE GOING TO BE A VERY HELPFUL IN TERMS OF MAKING THESE -- EXOSOMES USEFUL IN TERMS OF THERAPEUTICS. >> STEVE WHAT IS CHANGING IS THAT WE NOW ARE LEARNING ZIP CODES WHERE THEY ARE HEADED. AND WHERE WHAT IS DIFFERENT FROM THREE FOUR YEARS AGO WHERE THE EXOSOMAL RNA CONSORTIUM HAD TO BROADEN THE -- CONCERNING THAT, THAT'S THE OPPORTUNITY YOU SHOULDN'T MISS. SO THAT COUPLE THAT IN DIFFERENT WAYS YOU CAN CAPTURE SIMILAR COMPONENTS SIMULATING RNAs IF YOURY ARE ASSOCIATING WITH INVASIVE -- TO GET THESE IN YOU CAN CAPTURE THE CELLS IN THE NEIGHBORHOOD, YOU ARE EXPOSING TO YOUR EXOSOMES SO CAN UNDERSTAND DRUG AND OBVIOUSLY THERE IS A TIME ON CHIP AND N CATS BEAUTIFUL PLATFORM YOU CAN HAVE EXVIVO STUDIES TO SEE IF YOU BUILD THESE PROCESSES UP IN HUMANS IN VIVO STUDIES YOU CAN FOLLOW-UP MECHANISTICALLY AS WELL SO VERY NEATLY CROSS FERTILIZATION IN MANY ONGOING N CATS AND COMMON FUND ACTIVITIES. >> I WANT TO MAKE ONE MORE SUBSTANTIVE COMMENT BECAUSE OF SOMETHING SAID SINCE KEN TO MINE, WHICH IS WE ARE LOOKING FOR PURIFIED SOURCES TO DO BIOLOGY, ONE OF THE COOL THINGS I HEARD MORE RESEASON WILL I IN THIS ARENA IS THINKING ABOUT EXOSOMES IN THE CONTEXT OF GUT BRAIN ACCESS. SO THE POSSIBILITY THAT THE EXOSOMES MIGHT BE DERIVED FROM PARTICULAR BACTERIAL STRAIN IN YOUR GUT BUT HAS MEANINGFUL EFFECT IN THE NERVOUS SYSTEM MIGHT BE OUTLANDISH TO BELIEVE, ALLOWS YOU A TESTABLE HYPOTHESIS BECAUSE IT GIVES YOU A SOURCE OF EXOSOMES THAT YOU CAN ACTUALLY THEN PERHAPS MAKE IN LARGE CULTURES PURIFY, IDENTIFY, MIX AND MATCH, DO THOSE THINGS THAT MIGHT GIVE YOU MORE TRACTION INTO WHAT THE UNDERLYING MECHANISM MIGHT BE FOR THERAPEUTICS ATTENTION. >> THE MAIN AREAS FOR THERAPEUTIC APPLICATIONS RIGHTS NOW ARE HEART LUNG KIDNEYS NEURODEGENERATIVE DISORDERS, AND EVEN SUCH THING WOUND HEALING AND CANCER SO THOSE ARE THE MAIN CURRENT APPLICATIONS THE LOW HANGING FRUIT BUT THERE IS TREMENDOUS AMOUNT OF OPPORTUNITIES IN THIS AREA TO SEE WHAT THIS THERAPEUTICS TO DO. AND THE SYNERGISM WITH CHIP, WITH THAT WE CAN EVALUATE THAT THERAPEUTIC POTENTIAL AND BREAK THINGS DOWN A LITTLE BIT MORE. THERE IS SYNERGY BEAN THOSE TWO PROGRAMS AS WELL THAT MAKES EXCITING. THE TISSUE CHIP PROGRAM DOES HAVE BLOOD BRAIN BARRIER CHIP SO THAT WOULD BE A WAY TO LOOK AT THAT AND ASSESS THAT. >> THANK YOU SO MUCH CHRISTINE. I BELIEVE I WILL TURN TO ANNA NOW AS WE GET CLOSE TIME HERE. NEED TO TAKE A VOTE. I REMEMBERED. THROW IT OVER TO YOU. >> THANK YOU. HEARING NO FURTHER DISCUSSION, I WOULD LICK TO ASK YOUR APPROVAL FOR THIS CONCEPT, DO I HAVE A NOMINATION? >> MOVED. >> SECOND. >> SECOND? >> SECOND. >> ALL IN FAVOR? >> AYE. AYE. AYE. AYE. >> ANY OPPOSED? ANY ABSTENTIONS? WITH THAT THE SECOND CONCEPT OF THE DAY IS APPROVED. THANK YOU VERY MUCH. BACK TO YOU, JONI. >> THANK YOU SO MUCH ANNA AND REST OF THE TEAM FOR THE PRESENTATIONS TODAY. I THINK THIS IS THE MOMENT WE JUST WRAP UP OUR FIRST DAY HERE. AND I WANT TO INVITE YOU TO PROVIDE ANY COMMENTS OR QUESTIONS HERE BEFORE WE CLOSE OUT TODAY. JUST QUICKLY MAKE SURE I'M NOT SEEING ANY. ANY LAST MINUTE QUESTIONS PLEASE RAISE YOUR HAND. IN THAT CASE WE WILL RECONVENE TOMORROW AFTERNOON AT 1 P.M. EASTERN AND I LOOK FORWARD THE SEEING YOU BACK THEN. I DON'T NEED THE GAVEL OUT NOW BECAUSE WE ARE STILL IN OPEN SESSION UNTIL TOMORROW AFTER 5. STAY TUNED WE WILL SEE YOU TOMORROW, THANK YOU FOR YOUR ATTENTION AN ENGAGEMENT TODAY.