WELCOME TO THE--I THINK IT'S ACTUALLY THE 102 MEETING OF THE NATIONAL ARTHRITIS AND MUSCULOSKELETAL SKIN DISEASES ADVISORY COUNCIL. SO THE VIRTUAL GAVEL HAS JUST BEEN RUNG. SO THANKS EVERYBODY FOR JOINING US TODAY AND PARTICULARLY THOSE FOR WHOM IT'S 7:00 IN THE MORNING. THE COUNCIL MEMBERS ARE OPEN TO THE PUBLIC AS REQUIRED BY LAW EXCEPT FOR THE REVIEW, DISCUSSION AND EVALUATION OF GRANT APPLICATIONS OR RELATED INFORMATION WHICH WE WILL DO IN THE CLOSED SESSION THIS AFTERNOON. WE SENT EACH OF YOU A STATEMENT REGARDING CONFLICTS OF INTEREST WHICH EACH OF YOU HAVE SIGNED AND RETURNED TO US SO THANK YOU FOR THAT. BUT BEFORE WE PROCEED WITH THE BUSINESS OF THE MEETING, WE WOULD LIKE TO GO OVER CONSIDERATION OF MINUTES FROM THE LAST COUNCIL MEETING AND FUTURE COUNCIL DATES. MELINDA? >> GOOD MORNING AND WELCOME EVERYONE. THIS IS OUR SECOND VIRTUAL COUNCIL MEETING AND OUR COUNCIL MEMBERS AND LIMITED STAFF ARE ON THE WEBEX CALL THIS MORNING AND THE REST OF THE STAFF AND THE PUBLIC ARE WATCHING US VIA THE LIVE VIDEOCAST. IF ANY STAFFER IS WATCHING ON THE VIDEOCAST AND HAS AN URGENT COMMENT OR QUESTION, AGAIN, AS NEAL HAD SAID BEFORE PLEASE E-MAIL LIZ BORIS AT ELIZABETH.BORIS @NIH.GOV, AND SHE WILL REMIT THAT QUESTION TO ME. I WOULD LIKE TO REMIND VIEWERS THAT PUBLIC COMMENTS CAN BE MADE UP TO 15 DAYS AFTER THE COUNCIL MEETING AND THESE WOULD ALSO BE SENT TO ELIZABETH BORIS. ANYONE ON THE WEBEX CALL MAY SPEAK BUT PLEASE MAKE SURE, AGAIN THAT YOU MUTE YOUR LINES WHEN YOU'RE NOT SPEAKING. YOU CAN ALSO RAISE YOUR HAND, YOU CAN ALSO PUT A CHAT. NEAL ROBERTS WILL HELP WITH THE MUTING AND UNMUTING AND BE THE HOST WITH US TODAY AND ESPECIALLY WHEN WE'RE TAKING VOTES, HE WILL BE MANAGING THAT. SO IF COUNCIL MEMBERS NEED ANY COMPUTER SUPPORT OR HELP WITH THE ELECTRONIC COUNCIL VOTE DURING THE MEETING, AGAIN, PLEASE E-MAIL LIZ, LIZ HAS ALL THE CONFLICT OF INTEREST FORMS TO EVERYONE AND SHE TELLS ME THAT THEY'RE ALL BACK, SO THANK YOU AGAIN. REPORTING DATES ARE OCTOBER, FEBRUARY AND JUNE. SO WHEN YOU RECEIVED THE REQUEST, YOU MUST GET THEM BACK WITHIN 30 DAYS IN ORDER TO PARTICIPATE IN ANY COUNCIL RELATED ACTIVITIES. SO LET ME TURN TO THE MINUTES. WE'RE GOING TO TAKE A VOTE. SO IF THE COUNCIL MEMBERS COULD ACTUALLY UNMUTE YOURSELVES, FORGET WHAT I SAID EARLIER, EVERYONE WILL UNMUTE THEMSELVES, COUNCIL MEMBERS, YOU'VE ALREADY SEEN THE MINUTES OF THE JUNE 9th 2020 COUNCIL MEETING WHICH WERE POSTED IN THE ELECTRONIC COUNCIL BOOK. DOES ANYONE HAVE ANY COMMENTS OR CORRECTIONS TO THOSE MINUTES? HEARING NONE MAY I HAVE A MOTION TO,A PROVE THE JUNE 9th COUNCIL MINUTES. >> SO MOVED. >> SECOND? >> SECOND. >> SECOND. >> SAY AYE. >> AYE. >> AYE. OPPOSED? THE MOTION PASSES, THANK YOU. I'D ALSO LIKE TO--LET'S EVERYBODY GO ON MUTE AGAIN, PLEASE. I WOULD ALSO LIKE TO REMIND YOU THAT THE DATES THE FUTURE COUNCIL MEETINGS ARE IN THE ECB. OUR NEXT MEETING IS ON JANUARY 26th AND NIH HAS MADE THE DECISION THAT THE JANUARY AND FEBRUARY COUNCIL MEETINGS WILL BE VIRTUAL AS WELL AND WE VERY MUCH APPRECIATE YOUR PARTICIPATION IN THOSE MEETINGS SO JUST MAKE SURE THAT THOSE DATES ARE ON YOUR CALENDAR AND NOW I WILL TURN THIS BACK TO >> THANK YOU MELINDA, ONCE AGAIN, [AUDIO CUTS OUT ] WISH WE BEING BE PRESENT, I THINK EVERYBODY'S SAFE TRAVEL BUT WE'RE STILL IN A PANDEMIC AND OUR PRIMARY CONCERN IS EVERYONE STAY SAFE AND HEALTHY BUT THANKS FOR JOINING. SO MY--MY TALK TODAY IS GOING TO BE SEPARATED INTO 3 DIFFERENT SECTIONS, FIRST IS ON PERSONNEL CHANGES AT NIH AND NIAMS, AND THEN AN UPDATE ON THE NIH AND NIAMS BUDGET WHICH ACTUALLY WILL BE BRIEF AND THEN FOR THE DISCUSSION OF NIH AND NIAMS ACTIVITIES. SO MY FIRST ORDER OF BUSINESS WAS TO INTRODUCE DR. CRISWELL, AND DR. COLLINS ANNOUNCED DR. CRISWELL, AS THE THIRD DIRECTOR OF NIAMS, SHE SERVES AS VICE CHANCELLOR OF RESEARCH AT UNIVERSITY OF CALIFORNIA SAN FRN CISCO, SHE'S ALSO WITH THE DEPARTMENT OF MEDICINE AND PROFESSOR OF OROFACIAL SCIENCES IN THE SCHOOL OF DENTISTRY. SHE BRINGS RICH VARIANCES AS A CLINICAL RESEARCHER AND ADMINISTRATOR AT NIH, OR ABILITY TO OVERSEE 1 OF THE TOP 10 MEDICAL SCHOOLS AND HER DISEASES MAKES HER GREAT FOR THE DIRECTOR POSITION AT NIAMS, MORE IMPORTANTLY SHE HAS A SOLID RELATIONSHIP WITH OUR INSTITUTE, SHE WAS FUNDED CONTINUOUSLY SINCE 1997 AND SERVED THE INSTITUTE IN MANY CAPACITIES AND CURRENTLY MOST RECENTLY TO THE BOARD OF SCIENTIFIC COUNSELORS, WE EXPECT HER TO JOIN THE INSTITUTE IN 2021 AT WHICH POINT I WILL RETURN TO MY POSITION AS DEPUTY DIRECTOR WHEN I WILL SUPPORT AND ASSIST DR. CRISWELL, S SHE BRINGS NEW ENERGY, ENTHUSIASM AND VISION TO NIAMS. IT'S IMPORTANT TO KNOW LINDSAY WILL CONTINUE TO BE AN INVESTIGATOR AT UCSF UNTIL SHE ARRIVES AT NIAMS, THIS IS DIFFERENT BETWEEN THE ANNOUNCEMENT OF HER SELECTION WHICH IS WHAT DR. COLLINS ANNOUNCED AND HER ARRIVAL AND ACTUAL APPOINTMENT AS DIRECTOR WHICH WILL HAPPEN AS SAID IN EARLY 2021. UNTIL THEN THE LEADERSHIP AT THE INSTITUTE WILL REMAIN IN PLACE, HOWEVER, I DO WANT TO EMPHASIZE AGAIN HOW COMMITTED I AM TO ASSISTING HER IN HER TRANSITION AND HER TAKING THE HELM AS DIRECTOR AND I'M REALLY LOOKING IF ORDER TO THAT. SO LET'S SEE IF DR. CRISWELL IS ABLE TO SPEAK. >> DR. CARTER SHE IS ON THE PHONE, SHE WASN'T ABLE TO GET ON TO THE WEBEX BUT SHE IS ON THE PHONE WITH US. >> YES, CAN YOU HEAR ME? >> WE CAN, YES. >> A LITTLE LITTLE QUIET. >> I'LL SPEAK AS LOUDLY AS I CAN, TERRIBLY SORRY FOR THE TECHNICAL DIFFICULTIES. I WAS ABLE TO GET INTO THE LIVE VIDEOCAST BUT YOU COULDN'T SEE ME AND I COULDN'T GET INTO THE WEBEX SO I'M REALLY DELIGHTED AND THRILLED TO HAVE THIS PRIVILEGE. I'M GRATEFUL TO FOLLOW FROM BOB AND STEVE [INDISCERNIBLE] BEFORE HIM OF COURSE, I'M REALLY SORRY I CAN'T BE LOOKING AT YOU NOW ON MY SCREEN BUT I'M LOOKING FORWARD TO GETTING TO KNOW YOU ALL AND EVENTUALLY TO BEING ABLE TO MEET WITH YOU IN PERSON. SO I'M REALLY, REALLY GRATEFUL FOR THE SUPPORT AND IT'S A GREAT HONOR TO HAVE BEEN CHOSEN AND I'M LOOKING FORWARD TO TRANSITIONING INTO THIS NEW ROLE AND I'M SO GRATEFUL THAT I'LL HAVE THE SUPPORT OF DR. CARTER WITH HIS VAST EXPERIENCE AT NIAMS, I'M SURE THAT WILL BE A HUGE HELP IN ALLOWING ME TO GET UP TO SPEED QUICKLY SO THANK YOU SO MUCH. I'M SORRY THAT THIS IS NOT A MORE PERSONAL GREETING BUT I LOOK FORWARD TO MEETING WITH YOU VIRTUALLY AND EVENTUALLY IN PERSON OVER THE COMING MONTHS. THANK YOU SO MUCH. >> THANK YOU LINDSAY. I WANT TO SAY THAT SPEAKING ON BEHALF OF THE ENTIRE INSTITUTE AND REALLY IT'S THE ENTIRE INSTITUTE THAT IS THERE TO SUPPORT YOU AND WHAT'S REALLY REMARKABLE IS THE ROLE OF THE DIRECTOR IS SIMPLY TO ENABLE THE STAFF TO DO THEIR JOBS AND WHAT'S BEEN REMARKABLE IS HOW WELL THEY'VE DONE THEIR JOBS IN THE EXCEPTIONAL CIRCUMSTANCES, SO I THINK YOU WILL FIND THE PLACE--WE ALWAYS HAVE PROBLEMS, THERE ARE ALWAYS THINGS TO DEAL WITH, BUT THE STAFF IS JUST A THRILLING GROUP TO WORK WITH. SO THANKS FOR JOINING US. SO WE WILL MOVE TO THE NEXT SECTION OF TALK ABOUT NEWS FROM NIH. SO, LET ME CHECK THE NEXT SLIDE. RIGHT. SO, THERE HAVE BEEN 4 NEW INSTITUTE DIRECTORS IN ADDITION TO DR. CRISWELL, SINCE WE LAST MET WHICH IS PRETTY REMARKABLE. FIRST DR. MICHAEL CHANG IS THE NEW DIRECTOR OF THE NATIONAL EYE INSTITUTE, PRACTICING OPERATING GLOBALLY THAT WILL MALGST AND THE KNOWS PROFESSOR, IN CLINICAL EPIDEMIOLOGY AT OREGON HEALTH AND SCIENCE UNIVERSITY IN PORTLAND AND ASSOCIATE DIRECTOR OF THE OHSU KC EYE INSTITUTE. HIS RESEARCH INVOLVES TELEMEDICINE AND ARTIFICIAL INTELLIGENCE FOR DIAGNOSIS OF RETINAL LOCATIONINOSEIS AND OTHER OPHTHALMOLOGIC DISEASES AND MODELING CLINICAL WORK THROW AND DATA AND ANALYTICS. NEXT DR. RENA, D'SOUZA IS DIRECTOR OF THE NATIONAL INSTITUTE OF DENTAL AND CRANEIO FACIAL RESEARCH, SERVING AS ASSISTANT VICE PRESIDENT FOR ACADEMIC AFFAIR FOR HEALTH SCIENCES AT THE UNIVERSITY OF UTAH SALT LAKE CITY, PROFESSOR OF DENTISTRY AND [INDISCERNIBLE] SCHOOL OF DENTISTRY, ANATOMY, PATHOLOGY AND SURGERY IN THE SCHOOL OF MEDICINE AND THE DEPARTMENT OF BIOMEDICAL ENGINEERING. SO [INDISCERNIBLE] HER CURRENT RESEARCH FOCUSING ON THE MOLECULAR MECHANISMS UNDERLYING THE GENERAL ABSENCE OF 1 OR MERE TEETH, A CONDITION KNOWN AS TEETHE GENESIS. RICK WOYCHIK IS THE DIRECTOR OFLET NATIONAL INSTITUTE OF THE ENVIRONMENT HEALTH SYSTEMS WHICH HE'S BEENACKING ON SINCE OCTOBER OF 2019. HIS VISION IS INCORPORATE EPIGENETIC AND BIOLOGICAL VAIRMT FOR RESEARCH STRATEGIC PLAN KNOWLEDGEYS [AUDIO CUTS OUT ] FOR ENVIRONMENTAL TOXICOLOGY. AND DR. SHANNON ZENK IS THE DIRECTOR FOR THE NATIONAL INSTITUTE OF NURSING RESEARCH, SHE HOLDS THE TIELTS OF NURSING COLLEGIATE PROFESSOR IN HEALTH NURSES SCIENCE AT UNIVERSITY OF ILLINOIS AT UNIVERSITY OF CHICAGO AND A FELLOW OF THE OF THE UNIVERSITY'S INSTITUTE FOR HEALTH RESEARCH AND POLICY. HER RESEARCH FOCUSES ON SOCIAL INIQUITIES AND HEALTH WITH THE GOAL OF IDENTIFYING MULTILEVEL APPROACHES, THE IMPROVED HEALTH AND ELIMINATE HEALTH DISPARITIES. HER PIONEERING WORK, IN THE ENVIRONMENTAL IN FOOD DESERTS, ENVIRONMENT AND FOOD DESERTS HELP TO BRING NATIONAL ATTENTION TO THE PROBLEM OF INADEQUATE ACCESS TO HEALTHY FOODS TO LOW INCOME NEIGHBORHOODS. >> NEXT SLIDE AT NIAMS, IN OUR EXTRAMURAL RESEARCH PROGRAM DR. REYES IS OUR NEW DEPUTY GRANTS MANAGEMENT OFFICER, SHE COMES TO US FROM THE NATIONAL INSTITUTE OF AGING WHERE SHE SERVED AS A TEAM LEADER IN THE GRANTS SPECIALIST AND SERVED IS THE 10 YEARS GRANTS COMPLIANCE [AUDIO CUTS OUT ] AND THE NEXT SLIDE, SHOWS OUR FUNDING PLAN WHICH IS ACTUALLY NOT QUITE FINAL BUT WE STILL MAKING CHANGES TO TRY TO FIND AS MANY APPLICATIONS AS WE CAN. IT'S LIKELY THAT THE 2021 WILL START UNDER A CONTINUING RESOLUTION. I THINK--ASSUME YOU HAVE READ THE PAPERS AND THE DIFFICULTIES IN PUTTING TOGETHER AN ADDITIONAL BILL TO HELP WITH COVID AND ECONOMIC ISSUES IS AN ILLUSTRATION OF THE PROBLEMS TO COME IN PUTTING TOGETHER THE BUDGET. SO WE DON'T HAVE A CRYSTAL BALL AND I HOPE I'M WRONG BUT LIKELIHOOD IS THAT WE WILL BE ON A CONTINUING RESOLUTION UNTIL AT LEAST THE ELECTION. SO THAT MEANS WE DON'T KNOW WHAT OUR BUDGET WILL BE FOR NEXT YEAR AND WE HAVE TO START OFF WITH VERY CONSERVATIVE PROJECTIONS BECAUSE WE--IF CHANGES HAPPEN, LATER IN THE YEAR, WE HAVE TO BE READY TO ABSORB BOTH CUTS AS WELL AS HOPEFULLY ANY INCREASES. SO THIS IS THE INTERIM PLAN THAT'S SHOWN HERE BUT AGAIN, I DO WANT TO MAKE THE POINT THAT WE ARE STILL WORKING TO FIND AS MANY MERITORIOUS GRANTS AS POSSIBLE IN THIS FISCAL YEAR MPLET I DO WANT TO FOLLOW UP ON THE DISCUSSION WE HAD FOR THE BUDGET ON THE BUDGET MEETING. AS I SAID THEN, THE GOOD NEWS IS THAT EVEN THOUGH THE PAY LINE IS 11%, WE'RE FUNDING APPROXIMATELY THE SAME NUMBER OF GRANTS THIS YEAR AS IN THE PREVIOUS YEARS DESPITE THE INCREMENTALLY LOWER PAY LINE. I WANT TO SAY THAT I DO AGREE WITH [INDISCERNIBLE]'S POINT THAT SHE MADE AT THE LAST COUNCIL IS THAT WE NEED TO FUND MORE GRANTS. I THINK WE ALL WOULD AGREE WITH THAT AND WE WOULD LIKE TO INVOLVE COUNCIL IN DISCUSSIONS OF HOW WE WOULD--ADJUSTMENTS WE CAN MAKE TO FIND MORE GRANTS. BUT DURING THIS LEADERSHIP TRANSITION, IT WOULD BE INAPPROPRIATE FOR ME TO LEAVE THE FORMATION OF A NEW WORKING GROUP OR ANYTHING LIKE THAT UNTIL LINDSAY IS ON BOARD AND HAS A CHANCE TO DECIDE WHICH DIRECTION SHE WOULD LIKE THE INSTITUTE TO GO. SO AS I SAID, IN THE MEAN TIME WE WILL CONTINUE TO WORK TOWARDS FUNDING MORE GRANTS AND HOPEFULLY WILL RETURN TO THIS ISSUE AT A LATER DATE AND I JUST WANT TO REINFORCE THAT THE INPUT OF COUNCIL FROM THE TRADE OFFS BETWEEN CUTS TO SOME CURRENTLY AWARDED GRANTS AND BEING ABLE TO FUND MORE GRANTS IS IMPORTANT AND WE HOPE TO CONTINUE THAT DISCUSSION AT A LATER TIME. SO NEXT SLIDE, ADDITIONAL NIAMS ACTIVITIES. I WANT TO MENTION THAT OUR SCIENCE, COMMUNICATION BRANCH RECENTLY CIRCULATED AN ARTICLE THAT I WROTE ABOUT AND SUPPORT FROM THE EXTRAMURAL RESEARCHERS WHO HAVE BEEN INPACTED BY THE COVID-19 PANDEMIC. YOU CAN READ THE LETTER ON OUR WEBSITE BUT I WANT TO POINT OUT THAT NIAMS LIKE THE OTHER INSTITUTES AND CENTERS AT NIH, ARE 2 BASIC TOOLS TO HELP THOSE WHOSE RESEARCH [AUDIO CUTS OUT ] EXTENSIONS IN TIME, EXTENSIONS TO THE PROJECT PERIOD AND SUPPLEMENTAL FUNDING. WE CAN RESPOND TO REQUESTS FOR EXTENSIONS NOW. PARTICULARLY RELAILTED TO DEADLINES FOR TRAINEES. THEN WE WANT TO DO WHAT WE CAN AND BE ABLE TO RETURN TO THE LAB AS SOON AS POSSIBLE. HOWEVER, NIAMS CURRENTLY DOES NOT HAVE ANY FUND BEING AVAILABLE FOR COVID-19 RELATED SUPPLEMENTS, ANY SPECIFIC FUNDS. WE WILL HAVE A BETTER IDEA OF WHAT WE CAN OFFER ONCE WE KNOW WHAT OUR FISCAL 21 BUDGET IS, BOTH FROM COVID-19 SPECIFIC FUNDING AND FOR NONCOVID RELATED RESEARCH. BUT FOR THIS REASON WE RECOMMEND THAT EXTRAMURAL RESEARCHERS DELAY ANY REQUESTS FOR SUPPLEMENTAL FUNDING UNTIL THE FULL IMPACT OF THE PANDEMICOT RESEARCH PROJECT IS CLEAR, ALTHOUGH WE DO MAKE EXCEPTIONS FOR EXTREME HARDSHIPS AND IN THOSE CASES, IT'S VERY, VERY IMPORTANT THAT YOU CONTACT US AND WE STRONGLY SUGGEST THAT ANY RESEARCHER INTERESTED IN THE COVID-19 RELATED SUPPLEMENT DISCUSS THE VARIOUS OPTIONS WITH THEIR INSTITUTIONAL AIDS AND WITH THE RELEVANT NIAMS STAFF. THE STAFF CONVERSATION SHOULD EXPLORE THE USE OF REBUDGETTING AND CARRY OVER FUNDS AS WELL AS WHETHER AN ADMINISTRATIVE SUPPLEMENT IS THE BEST OPTION FOR THIS GRANT. NEXT SLIDE. THIS IS AN UPDATE ON SOME PREVIOUS BUSINESS. THERE'S BEEN OW FEW COUNCIL ROUNDS SINCE WE MENTIONED OUR STRATEGIC PLAN--TO DOWNLOAD FROM OUR WEBSITE AND DISTRIBUTED AND TO DISTRIBUTE WHEN THEY'RE TALKING ABOUT NIAMS SUPPORTED RESEARCH. THE DRAFT PROTOTYPES OF THESE HANDOUTS ARE AVAILABLE IN THE ELECTRONIC COUNCIL BOOK. I WANT TO THANK TONY ORO AND FORMER COUNCIL MEMBER BILL [INDISCERNIBLE] FOR ENCOURAGING US TO TAKE ON THIS PROJECT AT LAST SEPTEMBER'S COUNCIL MEETING. SO EACH OF THESE FILES WILL EMPHASIZE THE PLANS CROSS CUTTING THEMES AND WILL FOCUS EACH ON 1 OF 5 DISEASE AND TISSUE SPECIFIC AREAS INCLUDING SYSTEMIC AND AUTOIMMUNE DISEASES, SKIN BIOLOGY DISEASES, JOINT BIOLOGY, MUSCLE BIOLOGY [AUDIO CUTS OUT ]--SO NEXT SLIDE. JUNE, YOU HEARD ABOUT OUR PLANS TO ADDRESS THE PERENNIAL CHALLENGE OF HOW TO MAKE THE RESEARCH COMMUNITY MORE AWARE OF OUR FUNDING OPPORTUNITY ANNOUNCEMENTS AND PARTICULARLY 1S THAT BE OF INTEREST TO THEM. THIS HAS BEEN A TASK THAT I'VE BEEN FOCUSED ON FOR SEVERAL YEARS NOW AND JUST IN THE LAST MONTH, WE'VE NOW LAUNCHED AN E-MAIL NEWS LETTER AND TWITTER FEED SPECIFIC TO THE NIAMS FUNDING OPPORTUNITIES. AND SO WHAT YOU SEE HERE IS A PROTOTYPE OF WHAT AN E-MAIL BLAST WOULD LOOK LIKE WHERE WE WOULD NOTIFY THE COMMUNITY OF A FUNDING OPPORTUNITY AND IT MAY BE 1 THAT DRIVES FROM NIAMS AND MAYBE 1 THAT WE'RE SIGNED ON TO OR THROUGH BUILDING 1. BUT THE IMPORTANT POINT IS THAT E-MAIL ADDRESS THAT WE HAVE NOW, THE LIST WE HAVE NOW IS FOR CURRENTLY FUNDED AWARDEES, BUT THAT'S A VERY SMALL PART OF THE NIAMS RESEARCH COMMUNITY. SO, TO JOIN THIS LIST SERVE, YOU NEED TO ACTUALLY SIGN UP FOR IT IF YOU'RE NOT CURRENTLY AN AWARDEE. SO PLEASE INVITE THE ENTIRE NIAMS RESEARCH COMMUNITY TO SUBSCRIBE TO THE E-MAIL AND LIST, USING THE LINK POSTED ON THE SLIDE AND FOLLOW THE NEW TWITTER FEED WHICH IS ALSO SHOWN. NEXT SLIDE. SO WE ACTUALLY DO ASK OUR COUNCIL MEMBERS TO HELP US WITH THAT BECAUSE TO GROW THAT SUBSCRIBER LIST TO START TO REACH THE BROADER GROUP OF APPLICANTS, WE REALLY NEED TO SPREAD THE WORD THAT THIS LIST SERVE IS NOW AVAILABLE AND IS--AND MY THINKING WILL BE THE BEST WAY AS A SINGLE E-MAIL WITH A SINGLE SUBJECT ABOUT A SINGLE FUNDING OPPORTUNITY ANNOUNCEMENT IS THE BEST WAY TO STAY IN TOUCH WITH THE GRANT OPPORTUNITIES THAT WE HAVE. SO NOW I WANT TO SHIFT GEARS TO MENTION 2 TRANSNIH ACTIVITIES TO ADDRESS ISSUES RELATING TO INSURING THE SCIENTIFIC COMMUNITY PROVIDE A SAFE AND CONSTRUCTIVE ENVIRONMENT FOR EVERYONE TO DO THEIR JOBS. AS NIH DIRECTOR FRANCIS COLLYNNS AND COLLEAGUES NOTED IN THE JUNE 19th ARTICLE IN SCIENCE, SEXUAL HARASSMENT INCLUDING GENDER HARASSMENT PRESENTS AN UNACCEPTABLE BARRIER THAT PREVENTS WOMEN FROM ACHIEVING THEIR RIGHTFUL PLACE IN SCIENCE AND ROBS SOCIETY AND THE SCIENTIFIC ENTERPRISE OF DIVERSE AND CRITICAL TALENT. SO THE IN, IH IS NOW TAKING STEPS TO FOSTER HARASSMENT-FREE ENVIRONMENT IN OUR INTRAMURAL PROGRAMS AND AT GRANTEE INSTITUTIONS. TO THIS END, MOST RECENTLY, NIH ISSUED GUIDANCE TO GRANTEES THAT SETS CLEAR EXPECTATIONS FOR REPORTING WHEN A GRANTEE INSTITUTION HAS A FINDING OF SEXUAL HARASSMENT OF A PI NAMED ON AN NIH GRANT. THE NOTICE MAKES IT CLEAR THAT THE NIH EXPECTS ITS GRANT RECIPIENTS WHO REQUEST CHANGES IN EITHER INVESTIGATORS OR MOVEMENT OF GRANT TO A NEW RECIPIENT INSTITUTION TO PROPERLY INFORM THE AGENCY WHETHER CHANGES RELATED TO CONCERNS ABOUT SAFETY OR WORK ENVIRONMENTS. EQUALLY PRESSING IS THE SUBJECT OF ANTIRACISM AND IN FACT, OVER THE LAST COUPLE OF MONTHS HAS BEEN A CENTRAL FOCUS AMONG NIH LEADERSHIP FROM STARTING WITH FRANCIS AND LARRY TABAK AND ALL OF THE INSTITUTE DIRECTORS. ACROSS THE INSTITUTE, INCLAUDING OUR STAFF, OUR--AND PARTICULARLY IN THE OFFICE OF THE DIRECTOR, INTRAMURAL RESEARCH PROGRAM [AUDIO CUTS OUT ]--LEADERSHIP LEVEL AND THROUGHOUT THE INTRAMURAL PROGRAM TO ELIMINATE--]AUDIO CUTS OUT ] FUNDING. SO AS WITH THE SEXUAL HARASSMENT, YOU KNOW LIFE HISTORIES THAT WE HEARD OVER THE LAST 2 YEARS. THE STORIES WE'RE HEARING ON RACISM ARE ALSO IMPACTFUL AND INSIGHTFUL AS TO EXPERIENCES OF INDIVIDUALS WHO'VE BEEN SUBJECT TO THIS. WE WANT TO CONTINUE TO PROVIDE A WAY FOR THOSE WHO PARTICIPATE IN THESE CONVERSATIONS AND SHARE THEIR STORIES TO BE FREE OF BACKLASH. AND FRANKLY, THAT'S SORT OF WHERE WE ARE AT THE LEADERSHIP LEVEL AT THE MOMENT, OF MAKING SURE WE CAN CREATE AN AVENUE FOR COMMUNICATION THAT IS SAFE AND TRUSTED AND THAT'S NOT A TRIVIAL TASK. SO CURRENTLY, THERE'S A LOT OF INTROSPECTION AND THINKING. SO I HESITATE TO SHARE SPECIFICS BUT THERE IS A COMMITMENT TO CORRECT THE CULTURE AND TO BE ACCOUNTABLE TO INSURE THE CHANGES ARE REAL AND NOT JUST WINDOW DRESSING. SO I DO WANT TO SAY THAT THE LEADERSHIP IS TAKING A HARD LOOK AT THE STRUCTURAL RACISM THAT EXISTS ON CAMPUS AND HOW TO CORRECT THAT. WITHIN NIAMS, WE FORMED AN INTERNAL COMMITTEE TO HELP LEADERSHIP ADDRESS AND CORRECT BOTH OF THESE IMPORTANT PROBLEMS AND WE WILL CONTINUE TO UPDATE YOU ON THESE ACTIVITIES AS THEY MOVE FORWARD. SWITCHING GEARS, NEXT. THANK YOU. SO I WANT TO SHIFT FROM THERE TO BRIEFLY MENTIONING THE 3 TALKS THAT YOU WILL HEAR THIS MORNING. THE FIRST WILL BE BY DR. PATRICIA BRENNAN, DIRECTOR OF THE NATIONAL LIBRARY OF MEDICINE. WE WILL TAKEN--THEYUC ABOUT THE REQUIREMENT THAT ELECTRONIC HEALTH SYSTEMS PROVIDE THE CLINICAL DATA NECESSARY FOR NATIONWIDE INTEROPERABLE HEALTH INFORMATION EXCHANGE THROUGH THE ADOPTION OF THE U.S. CORE DATA FOR INTEROPERABILITY FOR THE USCDI STANDARD. NIH WOULD LIKE TO USE THE STANDARD SET OF HEALTHCARE DATA CLASSES, DATA ELEMENTS IN ASSOCIATED [INDISCERNIBLE] STANDARDS IN THE USCDI VERSION 1 TO ENABLE GREATER INTEROPERABLE EXCHANGE OF HEALTH INFORMATION OR CLINICAL RESEARCH AND CARE. SO THE USCDI IS THE WHAT OF THE DATA SHARING, WHAT SHOULD BE SHARED. FHIR OR FAST HEALTHCARE INTEROPERABILITY ABILITY RESOURCES WILL FOLLOW AND THAT WILL PROVIDE THE HOW. FOLLOWING DR. --NEXT SLIDE--FOLLOWING DR. BRENNAN'S PRESENTATION, DR. SUZANNEA SERRATE-SZTEIN WILL GIVE AN UPDATE ON THE AMP AND LESSONS LEARNED FROM THAT EFFORT CAN FORM TEAM SCIENCE MOVING FORWARD. NEXT SLIDE. A THIRD PRESENTATION WILL BE FROM DR. DAVID GEORGE FROM THE INSTITUTE OF BIOMEDICAL EMERGENCYING, AND DR. KAHA NA WILL INTRODUCE THE NEW DR. STEPHEN I. KATZ AWARD. AS YOU KNOW HE WAS DEEPLY INVOLVED WITH JUNIOR INVESTIGATORS AND HELPING THEM THROUGH THEIR CAREERS. THIS ACKNOWLEDGES STEVE'S ENTHUSIASTIC SUPPORT FOR RESEARCHERS IN THIS EARLY STAGE AND PROVIDES THEM WITH OPPORTUNITY TO LAUNCH CAREERS IN AREAS UNRELATED TO THE AREAS TO THE TOPICS OF THEIR POST DOCTORAL LABORATORIES. NEXT SLIDE. AND FINALLY JUST BEFORE LUNCH, DR. GAYLE, LESTER, WILL SPEAK ON CONCEPT CLEARANCE AND THE IDEAS THAT WILL BE PUT FORTH AS A CONCEPT FOR YOUR CONSIDERATION MPLET SO, FINAL SLIDE. THIS CONCLUDES THE MY FORMAL PRESENTATION AND I INVITE TO YOU ASK QUESTIONS ABOUT ANY OF THE TOPICS I'VE RAISED OR ANYTHING ELSE THAT'S ON YOUR MIND EITHER THROUGH THE CHAT FUNCTION OR RAISING YOUR HAND. SO I WOULD INVITE ANYBODY TO LEAD OFF WITH ANY QUESTIONS THAT THEY MIGHT HAVE. >> SORRY BOB. CAN SOMEONE SEND US THE LINK TO THE NEWS LETTER. I HAVE TO SAY I DID NOT WRITE THINGS DOWN FAST ENOUGH. >> YOU CAN GET THAT FROM LIZ THROUGH NANCY. >> DEFINITELY. I THINK THAT NANCY IN OUR COMMUNICATIONS OFFICE DOES HAVE A PLAN TO DISSEMINATE THAT TO EVERYBODY VERY, VERY SHORTLY. >> GREAT. >> AND WE DID JUST UPDATE THE LINK, SO, WE WILL GET YOU THE NEW 1 IF IT'S NOT AN EASY E-MAIL BUT ANYTHING YOU CAN DO TO HELP SPREAD THE WORD FOR THE LISTSERV, FOR ANYBODY THAT MIGHT BE INTERESTED IN ANY OF THE RESEARCH PROGRAMS THAT WE DO. THAT WOULD BE APPRECIATED MPLET. >> AND CAN WE SHARE THOSE FOR THE STRATEGIC PLAN OR ARE THOSE NOT QUITE READY FOR DISSEMINATION YET? >> NOT QUITE. PRETTY CLOSE. SHOULD BE A MATTER OF DAYS TO WEEKS. BUT AGAIN, THOSE WERE DEVELOPED AT THE REQUEST OF SOME OF YOU ALL, SO HOPE YOU'LL USE THEM AND DISSEMINATE THEM. >> AND THEY LOOK GREAT. >> SO-- >> JEN. >> I HAD A QUICK QUESTION, IN THE COVID-19 PERIOD, DID YOU NOTICE ANY DIFFERENCES IN THE AMOUNT OF GRANTS RECEIVED AND IS THERE ANY SHIFT IN THE GENDER BALANCE? >> THAT I HAVE SEEN AND I'M HESITANT BECAUSE I DON'T WANT TO GET IT WRONG. LET ME DO SOME HOME WORK AND FIND OUT WHAT DATE I DID SEE AND GET BACK TO YOU. SO ACTUALLY WE'LL HAVE--I DON'T KNOW IF IT WILL BE NANCY OR CINDY TO HELP ME REMEMBER TO PULL THAT DATA. IT COMES OUT OF BUILDING 1 FROM THE OFFICE OF EXTRAMURAL RESEARCH, SO I'LL HAVE TO GET BACK TO YOU ON THAT 1. >> THANKS. >> THANKS. >> DR. ABRAHAM. >> HOW ARE YOU? >> GOOD TO SEE YOU. >> JUST A QUICK QUESTION, I WAS SURPRISED TO SEE THE DIFFERENCE IN THE PAY LINE FOR KO8 AND THE K23, I WAS WONDERING WHAT THE HISTORY OF THAT IS? YOU ARE MUTED BOB. >> THANK YOU. KD--SALLY LAWFULTER [LAUGHTER] >> JOYS OF WEBEX, PONTIFICATING TO YOURSELF. WE USE THE STANDARDS NOT IN THE NIEWMERRIC PAY LINE BUT IN THE NUMBER OF GRANTS WE AWARD IN A SPECIFIC PROGRAM. HAVING SAID THAT, WE DO TRY TO MAKE SURE THAT WE'VE GOT A DESCENT CADRE OF CLINICAL CASE, THE KO8 AND THE K23S BUT THEY ARE SEPARATED IN TERMS OF LOOKING AT THE NUMBERS OF AWARDEES THAT WE HAVE IN EACH CATEGORY SO HENCE THE DIFFERENCE IN PAY LINE. TONY? >> HI, BOB. THANKS AGAIN FOR THE GREAT OVERVIEW, I JUST WANTED TO REITERATE THE--FIRST OF ALL TO THANK THE STAFF FOR PUTTING TOGETHER THE VERY--THE SUMMARIES OF THE 5 YEAR PLAN. I THINK THEY WILL BE VERY EFFECTIVE FOR THE COMMUNITY. SO THANK YOU VERY MUCH FOR DOING THAT BUT THE QUESTION I HAD WAS THIS NEED IN OUR COMMUNITY FOR THE COVID HELP--I GUESS, I KNOW THAT YOU WANT TO LEAVE THIS PLAN FOR THE NEXT DIRECTOR FOR LINDSAY BUT DO YOU HAVE SORT OF THOUGHTS ABOUT FOR THE COMMUNITY WHO ARE LISTENING IN TERMS OF THE POST DOCS AND TRAINEES WHO ARE SORT OF TRAPPED IN THIS TRANSITION BECAUSE OF COVID? WHAT ARE THE PRINCIPLES GOING FORWARD THAT WE MIGHT BE ABLE TO HELP THEM MAKE THIS REALLY PRECARIOUS TRANSITION DURING THE TIME OF COVID? BECAUSE REALLY THERE'S A CHANCE THAT WE COULD BASICALLY LOSE A WHOLE GENERATION OF TRAINEES BECAUSE OF THE--THIS DELAY, THE 1 OR 2 YEAR DELAY WE'RE SEEING. DO YOU HAVE ANY THOUGHTS ON THIS GOING FORWARD AND HOW WE CAN ACTUALLY HELP THAT? >> SO WE'VE SPENT A LOT OF TIME THINKING ABOUT THE--SO FIRST OF ALL IT IS A COMMITMENT ON THE PART OF THE INSTITUTE TO DO WHAT WE CAN TO HELP THE TRAINEES AS JUST THE HIGHEST PRIORITY. [AUDIO CUTS OUT ] THE K-AWARDEES, THAT'S WHEN I SAID THERE HAVE BEEN SPECIAL CIRCUMSTANCES WHERE WE HAVE SORT OF SCRAPED UP SOME FUNDS TO KEEP SOMEBODY IN BUSINESS. A COUPLE TIMES TO MY KNOWLEDGE WITH 1 OR 2 EXCEPTIONS, THAT'S PRETTY MUCH ONLY BEEN TRAINEES WHERE WE'VE BEEN WILLING TO PULL THOSE FUNDS. THE TRAINEES ARE ON AN RO1, IT'S A LITTLE MORE DIFFICULT AND THEIR--I THINK WE WILL HAVE TO GET INSTITUTIONAL HELP AS MUCH AS FROM NIAMS DIRECTLY. LIKE I SAID, WE LITERALLY DO NOT HAVE FUNDS RIGHT NOW FOR COVID SUPPLEMENTS. YOU KNOW, COME OCTOBER 1, I HAD HOPED THAT WE WOULD BE IN A BETTER PLACE. I AM NOT MAKING ANY LOBBYING, I'M NOT MAKING ANY REQUESTS FROM CONGRESS AND I WILL TRY TO GET THE FACTS AND THE FACTS WERE THAT IN SOME OF THE DRAFT LANGUAGE IN THE BILLS THAT WERE BEING PUT FORWARD AHEAD OF THE NEXT SUPPLEMENT, THE 1 THAT BLEW UP WAS LANGUAGE TO PROVIDE FUNDS TO NIH TO HELP PEOPLE OVERCOME THE FUNDS THAT WERE LOST DUE TO PAYING SALARIES OR KEEPING MICE ALIVE WHEN THE LABS WERE CLOSED. AS I SAID THOSE TALKS HAVE FAILED AND I BELIEVE CONGRESS IS IN RECESS AND I THINK IN THE MOST LIKELY EVENT WILL BE THAT ANY ADDITIONAL SUPPLEMENT THAT COMES OUT OTHER THAN THE NEW BUDGET WILL BE SMALLER IN SCALE. BUT THE BE POSSIBILITY EXISTS THAT THAT LANGUAGE TO HELP NIH KEEP ITS INVESTIGATORS IN BUSINESS AND MAKE THEM WHOLE AFTER THE LOSSES TO COVID WOULD MAKE IT INTO A BILL. I'M NOT ADVOCATING, I HOPE I'M JUST STATING FACTS. >> RIGHT. THESE ARE YOUNG PEOPLE THAT COULD ACTUALLY HAVE SOLUTIONS TO THE COVID CRISIS THAT ARE BASICALLY NOT BEING ABLE TO--BECAUSE MOST INSTITUTIONS HAVE FROZEN THEIR HIRING SO THAT THE POST DOCS CAN'T FIND JOBS AND THE TRAINEES CAN'T FIND POST DOC POSITIONS SO IT'S KIND OF FREEZING THEIR ENTIRE GENERATION HERE IN PLACE. >> SO IN THE BIGGER PICTURE TONY, IF THERE ARE NO FUNDS EAR MARKED OR PROVIDED BY CONGRESS ON TOP OF OUR BUDGET TO MAKE PEOPLE WHOLE, NEXT YEAR'S GOING TO BE PRETTY THIN IN TERMS OF NEW AWARDS. I THINK WE HAVE A COMMITMENT TO PEOPLE WHO WE'VE TOLD THAT THEY COULD USE THEIR FUNDS TO KEEP THE SALARIES GOING, ET CETERA BUT IF THERE ARE NO SUPPLEMENTAL FUNDS TO MAKE PEOPLE WHOLE, THE BIG PICTURE IS THAT THE FUNDS TO DO THAT ARE GOING TO HAVE TO COME OUT OF OUR COMPETING POOL PLUS PROBABLY SOME CUT TO THE NONCOMPETING POOL IN ORDER TO ACCOMPLISH IT BUT IT'S GOING TO BE A SKINNY YEAR IF THAT'S WHAT HAPPENS AND IN SOME WAYS IN NIGH MIND IT MAY EVEN BE A YEAR LOST IN ORDER TO COMPLETE THE PROJECTS THAT ARE UNDERWAY. AND THAT'S EVEN BEFORE YOU GET INTO THE WHOLE CONNUND DRUM OF CLINICAL TRIALS THAT GOT INTERRUPTED. SO IT'S A DIFFICULT PICTURE AND IT'S 1 TO THINK ABOUT CONTINUOUSLY AND LOOKING FOR AVENUES OF WAYS TO BRING PEOPLE IN, THEY HAD TO TALK ABOUT GOING BACK TO 1 OF THE--IN THE ERA, YOU ARE THE ARRA WHEN THERE WAS THAT PROGRAM TO MATCH INSTITUTIONS TO HIGHER NEW INVESTIGATORS AND THEN IT WAS PART OF THE ECONOMIC STIMULUS. THAT OPTION HAS BEEN DISCUSSED AT THE NIH LEVEL, I'M NOT AWARE THAT IT'S MOVED FORWARD BEYOND THAT. SO THERE ARE SOME POSSIBLE OBSTACLES BUT THE BIG PICTURE WILL BE SO IMPACTFUL THAT WE'VE GOT TO UNDERSTAND THAT BEFORE WE FIGURE OUT WHICH OF THESE TOOLS TO PULL OUT. NYEAH, THANK YOU VERY MUCH, BOB, I REALLY APPRECIATE YOUR THOUGHTS. >> DR. CARTER, THIS IS MELINDA, IN RESPONSE TO THE QUESTION EARLIER ABOUT DATA ON GRANT APPLICATIONS, CINDY KAUFMAN JUST PROVIDED A LINK TO AN OPEN MIC, THE MIKE LAUER BLOG WHICH IS CALLED AN EARLY LOOK IN APPLICATION SUBMISSIONS [AUDIO CUTS OUT ]--SO IT'S A PRETTY FAIRLY LONG REPORT WITH SOME DATA AND THAT SHOULD BE IN THE ECB IN A COUPLE OF MINUTES. >> THAT'S GREAT. APPRECIATE IT. I READ THE THING SO I WAS AWARE OF IT. THANK YOU SO MUCH FOR FINDING IT AND GETTING IT POSTED. THAT'S GREAT. >> ARE THERE ANY OTHER QUESTIONS FOR DR. CARTER? >> SO NEXT QUESTION THEN IS WHEN PATTY IS AVAILABLE? >> YEAH, SO WE ARE CALLING HER NOW BECAUSE YOU WERE VERY QUICK AND TALKED VERY QUICKLY AND WE WOULD APPRECIATE SOME MORE QUESTIONS, WE'VE ASKED HER TO COME ONLINE AT 10 MINUTES BEFORE 11, WHICH IS IN 7 MINUTES. IF THERE ARE NO MORE QUESTIONS, I SUPPOSE WE COULD TAKE A STRETCHING BREAK OR CERTAINLY LIKE TO HEAR IF THERE ARE OTHER QUESTIONS IF THAT WAS POSSIBLE. >> YEAH, IF YOU ARE IN YOUR PAJAMA BOTTOMS-- >> [SPEAKING AT ONCE ] >> HI, JEN. >> I POSTED A QUESTION IN THE CHAT, MAYBE YOU CAN'T SEE IT BUT IT'S GREAT TO HEAR THAT INITIATIVES THAT THE NIAMS AND THE NIH IS DOING REGARDING RACISM AND SEXUAL HARASSMENT HAS NIAMS PERFORMED A CULTURAL ASSESSMENT TO UNDERSTAND HOW THE NIAMS STAFF FEELS ABOUT THESE ISSUES? >> NIH CULTURE SURVEY, MORE FOCUSED ON SEXUAL AND GENDER HARASSMENT. I WILL SAY THAT THE RACISM ISSUE IS SORT OF BLOSSOMED, AS YOU ARE ALL AWARE NATIONALLY OVER THE LAST YEAR. THE GOOD NEWS IS THERE'S 2 DIFFERENT SURVEYS, 1 THAT WE'VE ALWAYS DONE FOR FEDERAL ENVIRONMENT, EMPLOYEE VIEW POINTS SURVEY WHERE IT'S SORT OF A GENERAL SURVEY OF [AUDIO CUTS OUT ] AND THEN THE OTHER 1 OF FOCUSED ON HARASSMENT AND THOSE TYPES OF ISSUES. I'M DELIGHTED TO SAY, THAT OUR NUMBERS, OUR NUMBERS WERE PRETTY GOOD. THEY WERE ALMOST ACROSS THE BOARD, BETTER THAN AVERAGE OR IN SOME CASES AT THE TOP. BUT THERE WERE AREAS WHERE THERE WERE ISSUES THAT WE IDENTIFIED AND SO, IT SORT OF SOUNDS--THIS IS MORE OF A PROCESS ISSUE BUT 1 OF THE THINGS THAT CAME OUT WAS THAT ALTHOUGH PEOPLE THINK WE'RE DOING GOOD THINGS, OUR COMMUNICATION OF WHAT WE'RE DOING IS NOT OPTIMAL. SO THE PROBLEMS ARE MORE WITH THAT LEVEL THAN AT THE FUNDAMENTAL LEVEL, I WOULD SAY, BUT YOU KNOW ANY CASE OF HARASSMENT ANY PLACE PARTICULARLY OF RETALIATION IS JUST UNACCEPTABLE. SO I DO NOT TAKE THE FACT THAT THE SURVEY CAME BACK WITH US NOT% HAVING ANY RED FLAGS. IT DOES NOT MEAN IT DOESN'T EXIST. >> WE'RE HEARING SOME FEEDBACK, IF EVERYBODY CAN MUTE THEIR PHONE PLEASE. >> THANK YOU FOR THAT, I LOOK FORWARD TO HEARING MORE ABOUT IT AND COMING COUNCIL MEETINGS AS WE GET THE PLANS TOGETHER. THESE ARE NOT EASY ISSUES. I THINK EVERY INSTITUTION IS STRUGGLING WITH IT AT THIS POINT AND THERE'S MULTIPLE APPROACHES SO OBVIOUSLY HEARING ABOUT WHAT EVERYBODY'S DOING, WE'LL BE ABLE TO SHARE IDEAS. >> ABSOLUTELY. AGREE. AT NIH, EACH INSTITUTE IS DIFFERENT AN MANY OF YOU KNOW, BUT SO THAT'S WHY WE DO PUT UP OUR OWN--SO THERE IS A--COUPLE OFFICES AT NIH WHICH HAVE BEEN TREMENDOUSLY HELPFUL. ONE WOULD ACTUALLY CALL CIVIL AND WE DID FORM THIS COMMITTEE, AND GAVE THEM A CHARGE AND THE NEXT STEP WILL BE GETTING THIS OFFICE CALLED CIVIL TO DO WHAT'S CALLED TRAIN THE TRAINER LESSONS FOR THE MEMBERS OF THE COMMITTEE AND THEN ONCE THAT'S DONE, THEN THE COMMITTEE CAN START THINKING ABOUT HOW TO ROLL THIS OUT--ANOTHER HOUR OF STARING AT A VIDEO AND HOPEFULLY WE CAN CLICK THROUGH THIS AS FAST AS POSSIBLE BUT AT THE SAME TIME MAKING IT CLEAR THAT THERE'S CERTAIN ACTIVITIES, CERTAIN BEHAVIORS THAT ENTIRELY UNACCEPTABLE. AND YOU KNOW THERE IS THAT DATA THAT THE TRAINING ON IMPLICIT BIAS CAN HELP, IT DOES ACTUALLY HELP REDUCE DISPARITIES AND OUTCOMES. SO STILL A WORK IN PROGRESS OF EXACTLY WHAT THE NIAMS PLAN WILL BE, THIS IS BEING LED BY RICK PHILLIPS AND OUR ACTING EXECUTIVE OFFICER AND BIG THANKS TO HIM FOR ORGANIZING THIS AND IT'S A VERY GOOD COMMITTEE AND VERY MUCH LOOKING FORWARD TO THEIR SUGGESTIONS. >> DR. ORO, DO YOU HAVE A NEW QUESTION OR IS YOUR HAND STILL UP FROM YOUR PREVIOUS QUESTION? >> OH, JUST A FOLLOW UP TO JUDGE, EN'S QUESTION WHICH WAS IN TERMS OF THIS IMPLICIT BIAS, BOTH WITH RACISM AS WELL, YOU KNOW THERE'S AN--IT REQUIRES TRAINING FOR ALL FUNDEES AND GRADUATE PROGRAMS, ACTUALLY IN TERMS OF YOU KNOW TRAINING--IS THERE A PLAN TO INCLUDE THIS TYPE OF IMPLICIT BIAS IN THAT REQUIRED TRAINING. BECAUSE THAT WOULD BE A GOOD PLACE TO PUT IT, JUST, YOU KNOW ETHICAL TRAINING FOR RESEARCHERS, THAT MIGHT BE A GOOD PLACE TO ACTUALLY SORT OF INCLUDE THAT IMPLICIT BIAS TYPE OF TRAINING, YOU KNOW FOR GENDER AS WELL AS FOR RACIAL ISSUES. >> AND CERTAINLY ON THE TABLE, YES. I'M NOT MYSELF UP TO DATE ON WHERE THE THINKING IS IN TERMS OF ROLLING THAT OUT TO THE COMMUNITY RIGHT NOW BUT IT IS CERTAINLY 1 OF THE THINGS THAT'S BEING DISCUSSED. >> ALL RIGHT, THANK YOU. DR. ABRAHAM, HAVE YOU A QUESTION? >> YEAH, I ALSO WANTED TO SORT OF FOLLOW UP WITH JEN'S QUESTION. AT OUR INSTITUTION, I CAN TELL YOU THAT WE'VE DONE A LOT OF NEW THINGS SINCE THE CRISIS. JUST TO GIVE YOU AN EXAMPLE, WE'VE ACTUALLY HAD TOWN HALL MEETINGS ON DIVERSITY AND ANTIRACISM THAT 1 OF MY OFFICE, 1 OF THE HATS I WEAR IS THAT I'M THE SENIOR ASSOCIATE DEAN FOR DIVERSITY AT CORNELL MEDICINE AND FROM THOSE TOWN HALL MEETINGS WHICH MANY OF THEM ACTUALLY HAD MORE THAN A THOUSAND FACULTY MEMBERS PARTICIPATING, WE SOLICITED IDEAS ON ISSUES AND YOU KNOW SOME OF THE RECOMMENDATIONINGS THAT CAME OUT OF THAT SORT OF SETTING WERE INSTITUTIONALLY ADOPTED AND THE LONG-TERM IS TO CONDUCT ON A REGULAR BASIS THE EXPLICIT/IMPLICIT BIAS TESTING THAT'S NOW REQUIRED FOR FACULTY AND STAFF AT CORNELL MEDICINE. AND WE ALSO CREATED A NEW CENTER FOR HEALTH EQUITY, OR INSTITUTE FOR HEALTH JUSTICE ACTUALLY AT NYP, USING A 50 MILLION-DOLLAR NEW DONATION WHICH IS ACTUALLY QUITE REMARKABLE TO SEE THE PEOPLE DONATING TOWARDS CAUSES LIKE THAT. WE'VE ALSO ADOPTED NEW POLICIES ON RACISM AND BIAS IN GENERAL, WE'VE ACTUALLY CREATED A NEW OFFICE FROM HR CALLED INSTITUTIONAL EQUITY OFFICE THAT DIRECTLY REPORTS TO ME AND IT IS DESIGNED TO BE AN INTERVENTIONIST OFFICE, NOT JUST AN EFFICACY FOR DIVERSITY OFFICE SO, STUDENTS OR FACULTY WHO ARE EXPERIENCE DISCRIMINATION OF ANY KIND WILL ACTUALLY BE ABLE TO DIRECTLY FILE THE COMPLAINT AND THAT WILL SCALE UP TO THE [INDISCERNIBLE]. SO THOSE ARE--THERE ARE A DOZEN SORT OF NEW INTERVENTIONS WE HAVE PUT IN PLACE BUT JUST TO ANSWER YOUR QUESTION, I THINK A LOT OF THESE THINGS HAVE TO MAKE DIFFERENT INSTITUTIONS TO A DIFFERENT SCALE BECAUSE IT'S THE RIGHT THING TO DO. >> YEAH, ON A LOT OF DIFFERENT FRONTS. SO, HANNAH VALENTINA HAS BEEN A REAL CHAMPION AT NIH AND PARTICULARLY SHE'S REALLY FOCUSED ON THE NUMBERS AND THE GOOD NEWS IS THAT--[AUDIO CUTS OUT ]--INCREASED OVER THE LAST COUPLE YEARS, THE BAD NEWS IS IT'S STILL LESS THAN 1 PERCENT OF OUR TOTAL GRANTS. SO THERE IS A COMMITMENT TO THIS IS NOT JUST TALK. WE ACTUALLY ARE TO FIX THIS AND FIX IT NOW. WE ARE NOT LEGAL ME--WE CANNOT CONSIDER RACE OR GENDER IN FUNDING DECISIONS. SO IN THE SENSE ANY SORT OF AFFIRMATIVE ACTION TYPE WORK ON THE LEVEL OF FUNDING, IF THAT'S NOT LEGAL, WHAT IS LEGAL IS THAT WE NEED A DIVERSITY PERSPECTIVES AND THAT'S BEEN A TALKING POINT THAT IF A COMPANY HAS A DIVERSE BOARD IT DOES BETTER THAN 1 THAT'S ALL PEOPLE LIKE ME. SO THERE'S A COMMITMENT THAT WE CAN CONSIDER DIVERSITY OF PERSPECTIVES IN FUNDING DECISIONS, AS WELL AS IT'S PERFECTLY LEGAL TO HAVE FUNDING OPPORTUNITIES TARGETED TO SPECIFIC POPULATIONS. SO I THINK BETWEEN THOSE 2 THINGS, I THINK I AM HOPEFUL THAT WE WILL--THE NUMBERS AT NIH WILL DO BETTER. AND AGAIN, THE COMMITMENT IS THAT THIS IS NOT TALK, THIS IS A FUNDAMENTAL WAY OF CHANGE AND AS YOU ALL KNOW, IT'S REALLY TOUGH TO CHANGE AND SOMETIMES IT'S JUST, YOU DO COME UP AGAINST THESE LEGAL THINGS BUT THE IDEA THAT ACADEMIC MEDICINE OR NIH HAS FUNCTIONED ON THE MANIFESTATION MENTALITY PART OF THE CONVERSATION-- >> BOB, THIS IS KAREN. >> HI, KAREN. >> I APPRECIATE THAT EVERYONE IN YOUR INSTITUTIONS ARE PUTTING IN THE ANTIRACISM COMPONENTS AND POLICIES, I THINK THAT'S A HUGE STEP FORWARD FOR US. AS A NATION, I WANTED TO JUST INQUIRE IF YOU'RE ALSO INCLUDING IN THAT DIVERSITY STATEMENT OR IF IT'S IN THE LANGUAGE ANYWHERE ABOUT DISABILITY AND VISIBLE DIFFERENCES. BECAUSE I THINK RACISM IS A HUGE UMBRELLA NOW THAT ADDRESSES SKIN AND COLOR BUT I JUST WANT TO INQUIRE AND SEE IF WE ARE ALSO INCLUDING VISIBILITY DIFFERENCES IN DISABILITIES IN THOSE STATEMENTS? >> YEAH, YEAH, KAREN, ABSOLUTELY. I THINK THE FOCUS OF THE LAST FEW MONTHS HAVE BEEN ON RACISM BUT WE HAVE ACTUALLY BEEN LONG STANDING VERY SOLID POLICIES THAT ARE RESEARCH MORE BROADER THAN JUST RACE AND ETHNICITY AND WE HAVE A VERY, VERY BROAD POLICIES ON DISABILITY AND OTHER FORMS OF DISTINGUISHING SORT OF FEATURES WHETHER IT'S BIOLOGICAL OR PHYSICAL. SO YES, I THINK THE ANSWER IS YES, BUT I WAS JUST MAKING REMARKS ABOUT THE CURRENT SORT OF FOCUS ON RACE, AND THAT'S WHAT WAS ON THE FOREFRONT BECAUSE THAT'S LAWN MOWER WE FOCUS ON OUR ATTENTION ON, YES, BUT I WANT TO ACTUALLY GO BACK TO BOB, BOB, I NOTED TO ASK YOU ABOUT THE NIH INITIATIVE ON HIRING, IS THAT STILL ON THE BOOKS OR IF THAT HAS SORT OF DISSIPATED. >> TO MY KNOWLEDGE I AGREE WITH YOU, I HAVEN'T HEARD AS MUCH IN 2 OR 3 MONTHS. I DON'T KNOW IF ANYBODY ELSE FROM STAFF KNOWS OF ANY UPDATE OF WHERE THIS FUNDING OPPORTUNITIES ARE BUT THAT STILL IS THE THINKING THAT HIRING NOT PEOPLE INTO 1 DEPARTMENT ISN'T THE THING BUT IS HIRING A GROUP OF PEOPLE AS A CLUSTER WHO MAY BE IN DIFFERENT DEPARTMENTS BUT CAN WORK IN DIFFERENT DEPARTMENTS ON A COMMON THEME IS A WAY TO KEEP PEOPLE AND CREATE AN VIERPT THAT WILL BE HOSPITABLE AND WELCOMING AND THAT 1-OFF HIRES OF PEOPLE WHO FEEL ISOLATED IS NOT THE BEST SOLUTION. SO THANK YOU ALL. THAT'S WONDERFUL, I WANT TO SEE IF PAT SEON? >> CAN I JUST ADD 1 MORE THING, LINKS TO THE NEWS LETTER AND WE HAVE LINKS TO OUR TWITTER ACCOUNT. WE PUT THOSE ON THE ECB RIGHT NOW AND LATER ON SHE WILL ALSO SEND IT OUT TO YOU ALL. >> THANK YOU. >> BOB, WE WERE NOT ACTUALLY ABLE TO CONTACT PATTY. >> SHE'S ON. >> EXCELLENT. >> SHE'S ON, IT LOOKS LIKE. >> SO WE ARE GETTING SOME FEEDBACK, SO IF EVERYONE COULD MUTE. NTHIS IS NEIL, PATTY, IT LOOKS LIKE YOU ARE ON, YOU ARE ON MUTE. >> GOOD MORNING. >> LET ME DO A BRIEF INTRODUCTION. SO I MENTIONED BEFORE THE IMPORTANCE OF THE STRUCTURED DATA BECAUSE IT REALLY IS ESSENTIAL TO ALMOST SO MUCH OF THE HUMAN STUDIES WE SUPPORT AND IN FACT IT'S BEEN SORT OF A THORN IN OUR SIDE THAT EUROPE HAS BEEN ABLE TO DO THIS WORK MUCH MORE READILY THAN WE CAN BECAUSE WE HAVEN'T HAD THE SHARED DATA. SO SHE WILL INTRODUCE US TO THIS NEW EFFORT TO ENCOURAGE THE NEWS OF THE DATA STANDARDS AND RESEARCH TO HELP NIH ACHIEVE ITS DATA SCIENCE AND OPEN SCIENCE GOAL BUT ON A PERSONAL NOTE, I WANT TO SAY HOW MUCH A APPRECIATED PATTY ALONG WITH SUSAN GREGURICK, DRIVING FORWARD SCIENCE FOR NIH, BUT I WANT TO ADD I'M DEEPLY GRATEFUL TO PATTY BECAUSE SHE'S BEEN A REAL SOURCE OF HELP AND SUPPORT THESE 2 YEARS SO WITH THAT, PATTY THANK YOU FOR JOINING US. >> PATTY, IF YOU ARE SPEAKING, YOU ARE ON MUTE. >> GOT IT. OFF MUTE AND YOU HAVE ME CLEAR? >> YES, SO I STARTED OFF BY SAYING THANKS VERY MUCH FOR THAT KIND INTRODUCTION AND I APOLOGIZE FOR NIGH DELAY, MY CALENDAR MUST HAVE BEEN INCORRECT AND I AM VERY, VERY EXCITED ABOUT THE OPPORTUNITY TO SPEAK TO THIS PARTICULAR COMMUNITY BECAUSE OF YOUR DEEP COMMITMENT TO COMMUNITY BASED BOTH INSTITUTIONAL AND HOME BASED CARE. THE NATIONAL LIBRARY OF MEDICINE HAS BEEN SUPPORTING THE NIH IN DRIVING FORWARD THE BETTER USE OF CLINICAL DATA FOR RESEARCH AND OUR GOAL HERE IS REALLY TO KEEP A FOCUS ON TRYING TO COME UP WITH A WAY TO MAKE SURE THAT DATA THAT'S COLLECTED ONCE IN THE CLINICAL AREA, ULTIMATELY BECOMES USEFUL AND BENEFICIAL TO PEOPLE WHO ARE--EEIVETTUALLY WANTING TO USE THAT DATA FOR RESEARCH. NOW REMEMBER, ALONG THE WAY, THERE'S MANY, MANY THINGS THAT HAVE TO GO INTO USING CLINICAL DATA FOR RESEARCH. SO IT'S NOT SIMPLY A POSSIBILITY OF CAPTURING THE DATA BUT IT'S ALSO CAPTURING IT WITH THE PATIENT'S PERMISSION, GETTING IT IN A WAY THAT ACTUALLY,A LOWS FOR THE LOWEST BURDEN ON THE CLINICIAN AND THE POINT OF CARE ACTIVITY AS WELL AS MAKING SURE THAT WE ARE PROVIDING THE INFORMATION, DRIVING NEW KNOWLEDGE BUILDING AND THEN GETTING THAT KNOWLEDGE BACK INTO THE CLINICAL CARE AREA. LET ME GO--NEXT SLIDE, PLEASE BECAUSE I WANT TO TELL YOU ABOUT THE--PUT THIS IN A MUCH LARGER CONTEXT, OVER THE LAST 18 MONTHS THE NIH HAS BEEN REALLY EMPHASIZING ACCEL BRATEING RESEARCH BY LEVERAGING ELECTRONIC HEALTH RECORDS. ABOUT 15 YEARS AGO THE UNITED STATES EMBARKED ON AN INITIATIVE TO [AUDIO CUTS OUT ]--FACILITIES AROUND THE COUNTRY. THE IN, IH WAS A PARTY TO THAT IN THE SENSE THAT WE BECAME THE HOST FOR THE TERMINOLOGIES THAT ARE USED. THERE ARE MANY OTHER THINGS THAT WILL BE SPEAKING ABOUT THIS MORNING BUT YOU WILL HEAR A LOT OF NIH AND NLM PARTICIPATING AND ACTUALLY BEGAN UNDER THE OFFICE OF THE NATIONAL COORDINATOR FOR HEALTH IT. THE HAPPENING WAS WE NEEDED A PLACE TO COORDINATE STANDARDS, PURCHASING POWER AND COORDINATING ELECTRONIC RECORDS SO THE OFFICE OF THE NATIONZAL COORDINATOR BECAME THAT SPOT. THE INCENTIVE STRATEGY ON THE OTHER HAND CAME OUT OF CMS. AT THE TIME MEDICARE AND MEDICAID JOINED IN THE IDEA THAT CLINICAL RECORDS SYSTEMS TO BE USEFUL HAD TO BE MEANINGFUL PHRASE MEANINGFUL USE CAME FORWARD AND INSTITUTIONS BEGAN TO FIRST BE INCENTIVIZED AND THEN BE COMPENSATED FOR CARE THAT WAS PROVIDED IN A WAY THAT WAS DOCUMENTED BY ELECTRONIC HEALTH RECORDS [CHECK] WE'RE GOING TO HAVE SOME TIME, BOB, I THINK WE HAVE TILL THE HALFFUL HOUR, RIGHT? FOR MY SESSION? SO WE'RE GOING TO HAVE--I WILL LEAVE TIME AT THE END BECAUSE I'M SURE SEVERAL OF YOU HAVE QUESTIONS OR COMMENTS. , WE DO HAVE UNTIL 11:40. >> 11:40, OKAY, THAT'S BETTER. SO I WILL HAVE PLENTY OF TIME FOR CONVERSATION AND I'M SURE WILL THERE WILL BE A LOT OF QUESTIONS, AND YES, ELECTRONIC HEALTH RECORDS ARE HERRIBLE AND HOW PHYSICIANS HATE THEM AND WE CAN TALK ABOUT THAT ALSO BECAUSE THE IMPLEMENTATION--[AUDIO CUTS OUT ]--PRESENTATION IS GOING TO BE ON THE FOCUS ON THE DATA THAT'S INSIDE THE RECORD SO I WILL GIVE YOU AN OVERALL CONTEXT OF THE 5 KEY POINTS THAT ARE ON THE SCREEN FIRST, TALK A LITTLE BIT ABOUT THE NATIONAL LIBRARY OF MEDICINE IS SUPPORTING THESE AND THEN TALK A LITTLE ABOUT THE END AT THE U.S. CORGREATIGATE FOR INTEROPERABILITY. FIRST WE BEGIN WITH TERMINOLOGIES. TERMINOLOGIES ARE THE FORMAL LANGUAGES THAT REPRESENT THE CONCEPTS OF PATIENT CARE, THEN FIRE, FAST HEALTHCARE INTEROPERATIVE RESOURCE, THAT IS A MESSAGING STANDARD, IT'S ESSENTIALLY A TRANSPORT STANDARD, ONCE WE KNOW WHO SHOULD BE IN THE MESSAGE WE HAVE A WAY OF SORTING IT OUT AND READ AND INTERPRETED IN A PROPER BY BY COMPUTER SYSTEMS. >> THIRD WHAT WE REFER TO AS COMMON ELEMENTS. COMMON DATA ELEMENTS THAT RESEARCHERS IN SOME CASES CAN USE AS THE CRITICAL SET TO DESCRIBE A PARTICULAR PHENOMENON. THINK FOR EXAMPLE ABOUT PAIN OR FUNCTION, THE NLM SUPPORTS A REPOSITORY FOR COMMON DATA ELEMENTS AND SUPPORTS THE IMPLEMENTATION OF COMMON DATA ELEMENTS FOR QUESTIONNAIRES SO THAT RERESEARCHERS ARE ABLE TO BRING FORWARD AND EASILY IMPLEMENTED THESE COMMON DATA ELEMENTS IN THEIR RESEARCH AND ALSO THE FIRE IMPLEMENTATION ALLOWS US TO EASILY CONNECT THEM. VALUE SETS ARE A DIFFERENT KIND OF COLLECTION OF TERMINOLOGIES ARE ORGANIZATIONS OF PARTICULAR INDICATORS OF PROBLEMS THINK FOR EXAMPLE WHAT CHARACTERIZES DIABETES OR WHAT IS ESSENTIAL TO MAKE A COVID DIAGNOSIS, RARELY IS SUCH A LABBATORY TEST, WITH RESPECT TO DIABETES, MAYBE A HEMOGLOBIN A-1 C, COUPLED WITH DAILY BLOOD SUGARS AND COUPLED WITH RESPONSE TO INSULINS AS WELL AS FRANKLY DEMONSTRATE THE QUALITY CARE THEY'RE GIIVE AND FINALLY WE WILL TALK ABOUT RESEARCH. THIS IS MY OVERVIEW FOR THE TALK THIS MORNING. NEXT SLIDE, PLEASE. THIS REQUIRES THE USE OF MEANINGFUL HEALTH RECORDS THEY DWECHED SOMETHING CALLED THE UNIFIED MEDICAL SYSTEM, THIS IS CROSS MAPPING ACROSS ALL OF OUR VARIOUS TERMINOLOGIES BUT THE 3 I'M MOST FAMILIAR WITH IF YOU WORK IN CLINICAL CARE AT ALL ARE THE 3 BELOW THIS. SNOMED CT, THE STANDARD NOMENCLATURE OF MEDICINE CLINICAL TERMS. RX NORM WHICH IS A NORMALIZED SET OF NORMS AND CLINICAL VOCABULARIES AND FINALLY LOINC, LOGICAL OBSERVATIONS IDENT FERS NAMES AND CODES, CLINICAL TERMINOLOGY IMPORTANT FOR LABORATORY TESTS ORDERS AND RESULTS. ANY SYSTEM THAT'S CERTIFIED AS BEING APPROPRIATE FOR USE IN THE UNITED STATES OR THAT IS DEEMED TO BE MEANINGFULLY USEFUL WILL INCLUDE SOME OF THESE TERMINOLOGIES AND LABELING CLINICAL PROBLEMS AND DIAGNOSIS, SNOMED CT IS AN INTERNATIONAL STANDARD, THE IHT, SDO SIMPLY SAYING THIS IS AN INTERNATIONAL HEALTHCARE TECHNOLOGY STANDARDS DEVELOPMENT ORGANIZATIONS. ON BEHALF OF THE NIH AND THE COUNTRY AS A WHOLE THE NATIONAL LIBRARY OF MEDICINE PARTICIPATES IN THE IHT STO, ACQUIRES SNOW MED AND DISTRIBUTES IT AT NO COST TO THE COUNTRY, SO THERE SAY REFERENCE TERMINOLOGY THAT CLINICAL INFORMATION SYSTEMS ARE ABLE TO USE TO ESSENTIALLY INCORPORATE INTO THEIR SYSTEM. THE DECISION TO TO INVEST THIS WAY RATHER THAN HAVING EVERY HOSPITAL HAVE TO PURCHASE ITS OWN TERMINOLOGY SYSTEM HAPPENED UNDER SECRETARY THOMPSON'S LEADERSHIP MANY, MANY YEARS AGO. THE IDEA BEING IF THE UNITED STATES GOVERNMENT PROVIDED ACCESS TO A TERMINOLOGY, WE WERE MORE LIKELY TO GET IT ADOPTED ACROSS USE. THE TERMINOLOGY IS UPDATED EVERY YEAR TO REFLECT NEW TRENDS AND INFORMATION, IT'S AN INTERNATIONAL STANDARD, THERE ARE CERTAIN TERMS THAT APPEAR IN THE U.S. EXTENSION THAT DON'T APPEAR IN THE EUROPEAN EXTENSION BUT BY AND LARGE SNOMED AND SNOMED-CT IS SAN INTERNATIONAL STANDARD. RX NORM WAS BUILT AT THE NATIONAL LIBRARY OF MEDICINE. IT IS BUILT IN CLOSE COLLABORATION WITH THE FDA AND IT IS A WAY TO DEVELOPED NORMALIZING AND STANDARD NAMES FOR KLUGS AND DRUG FOCUSED ON VABULARYS, THERE ARE 17 DIFFERENT WAYS THAT TYLENOL APPEARS IN THE RX NORM BECAUSE OF THE DOSAGE STRENGTH, BECAUSE OF THE FORM IT'S IN, LIQUID, GEL, CAPSULE, EACH OF THOSE IN--PRESCRIBING FOR MEDICATIONS BUT RECENTLY IT'S BEEN VERY IMPORTANT IN WHAT WE CONSIDER MEDICATION RECONCILIATION, MAKING SURE WE UNDERSTAND WHAT A PERSON IS ACTUALLY TAKING. ONE OF THE KEY ASPECTS OF NORMALIZED DRUGS WHICH WAS NOT SURPRISING TO IA CLINICAL OR SCIENTIFIC AUDIENCE IS THE FACT THAT MANY DRUGS HAVE A COMMERCIAL NAME THAT'S DIFFERENT THAN THE PHARMACOLOGICAL NAMES AND RX NORMAL HAS A BEHIND THE SCENES ENGAGEMENT OF THAT. LOINC THE OBSERVATIONS IDENTIFIERS AND NAMES AND CODES WAS EXPANDED TO A LABORATORY AND AND INTERNATIONAL CLASSIFICATIONIGATORS, IT ALLOWS A SPECIFIC LAB RAARE TOY TEST WITH THIS PARTICULAR SAMPLE ON THIS PARTICULAR DEVICE RUN AGAINST THIS PARTICULAR SET OF NORMS TO BE RECORDED IN A PROPER FASHION. NEXT SLIDE, PLEASE. JUST TO SHOW YOU WHAT LOINC LOOKS LIKE RIGHT NOW FOR COVID TESTING, YOU SEE ACROSS THE SCREENS HERE THE MANUFACTURES, MODELS, VENDOR, NAME, THE SPECIMEN DESCRIPTION WHETHER IT'S NAISAL SWAB, NAISAL FACAS RENCHIAL, THE WAY THE RESULTS WITH CAN BE PRESENTED, POSITIVE, NEGATIVE, INVALID, THERE'S NO TEST AT THE END OF THIS PRESENTATION, AND YOU WON'T NEED TO MEMORIZE THIS BUT WHAT YOU NEED TO KNOW UNDERNEATH ALL ELECTRONIC HEALTH RECORD SYSTEMS IS THAT SECOND COLUMN FROM THE LEFT, THERE'S A COMPUTABLE CODE THAT BE UNDERSTOOD BY THE COMPUTER SYSTEM TO MAKE THESE INTERPRETATIONS. WHEN WE ARE STARTING TO STUDY MASSIVE ACCESS TO TESTING SUCH AS UNDER THE RADX PROGRAM, THESE LOINC CODES WILL BE PARTICULARLY IMPORTANT FOR US TO BE ABLE TO RECORD. NOW I'VE SPOKEN TO YOU SO FAR ABOUT THE TERMINOLOGIES WE USE, SENDING ELECTRONIC MESSAGES FROM 1 CLINICAL RECORD SYSTEM TO ANOTHER OR EXTRACTING CLINICAL DATA FOR A RESEARCH PURPOSE REQUIRES NOT ONLY KNOWING WHAT THE WORDS MEAN BUT KNOWING THEY'RE IN A PREDICTABLE FORMAT. NEXT SLIDE, PLEASE, AND THAT'S WHERE THE 5 STANDARD COMES INTO PLAY. THE 5 STANDA ARD WAS DEVELOPED OVER THE LAST--OH MAYBE, GOSH NOW 5 YEARS AS A WAY TO PROVIDE AN INTERNATIONAL FORMATTING OF STANDARD. THIS MEANS THAT ANY RECORD SYSTEM THAT IS EXPORTING A PARTICULAR CLINICAL OBSERVATION OR LABORATORY TEST OR DIAGNOSIS KNOWS THAT THE MESSAGE WILL COME OUT IN A CERTAIN ORDER, MAISHT NAME FIRST, DIAGNOSTIC TEST IS SECOND, THIRD MAY BE INSTITUTION, NAME AND ADDRESS, THE FOURTH FIELD BE THE SPECIFIC RESULTS THAT, STRUCTURE IS A LOT LIKE THE STRUCTURE ON THE OUTSIDE OF YOUR ENVELOPES WHEN YOU'RE SENDING A LETTER, THE FIRST NAME--FIRST LINE IS CONVENTION THE RECIPIENTS NAME, SECOND LINE IS THE STREET ADDRESS, THIRD LINE IS THE CITY AND STATE. FIRE IS SIMPLY AN ELECTRONIC STANDARD THAT MIMICS IN THE COMPUTER WHAT THAT CONVENTION OF USING ENVELOPES IS FOR OUR EVERY DAY CORRESPONDENCE IF YOU'RE STILL WRITING HANDWRITTEN LETTERS. >> NEXT SLIDE PLEASE, FHIR, IS 1 STEP THAT TAKESITOUS MAKING INFORMATION FAIR, JUST STAY ON THAT SLIDE, BUT GO TO THE PREVIOUS SLIDE PLEASE, MAKING INFORMATION FAIR FHIR MEANS MAKING IT FINDABLE, ACCESSIBLE, INTEROPERABILITY AND REUSABLE, AND HAVING THE PROPER SET OF TERMS, INFORMATION CODED IN A CERTAIN WAY AND HAVING A SET OF REFERENCE TERMINOLOGIES IS WHAT HAPPENS TO MAKE THIS HAPPEN AND IT'S CRITICAL NOW FOR RESEARCH AS WE RECOGNIZING INCREASINGLY THAT THE CLINICAL TRIALS AND CLINICAL STUDIES THAT WE'RE TRYING TO CONDUCT THROUGH THE NIH ARE INCREDIBLY EXPENSIVE AND THE AMOUNT OF TIME SPENT SENDING CLINICAL NURSES IN OR CLINICAL PHARM CYSTS INTO HAND TRANSCRIBE INFORMATION AT CLINICAL RECORDS ON TO STUDY FORM SYSTEM BECOMING--JUST UNSUPPORTABLE, SO THE MORE WE CAN LEVERAGE ELECTRONIC HEALTH RECORDS AND MAKE THEM USEFUL FOR RESEARCH, THE BETTER OFF WE'LL BE. SO THE NEXT SLIDE PLEASE. SO HERE'S WHAT WE'VE BEEN DOING AT THE NIH RECENTLY. WE SEE THESE OPPORTUNITIES FOR INCREASING ACCESS TO CLINICAL DATA AND THE DESIRE TO MAKING DATA FROM A SINGLE STUDY, ONCE COLLECTED, STORE INDEED A STANDARD FORMAT SO IT CAN BE USE INDEED OTHER STUDIES THAT'S WHAT WE CALL RESEARCH REUSE. IN THE NIH IN JULY OF 29 RELEASED GUIDANCE INCREASING USE OF THE FHIR'S STANDARD THAT INFORMATION AVAILABLE FROM CLINICAL RECORD SYSTEM EXPORT INDEED A WAY THAT'S CONSISTENT AND EXPECTED BY CLINICAL RESEARCHERS. SO IT REDUCES THE SECOND STEP OF HAVING TO GET CLINICAL INFORMATION. IN THE SUMMER OF 19 WE LAUNCHED 2 INITIATIVES TO MAKE FHIR TOOLS MORE USEFUL. THOSE ARE THE CONTRACTS LISTED IN THE LOWER PART OF THE SECOND COLUMN. --NOW IT'S POSSIBLE TO EXPORT DATA FROM A CLINICAL DATA DIRECTLY INTO A RED CAP AND USING THIS STABBED ARD. WE NEEDED TO FIND WAYS TO RECORD GENOMIC INFORMATION FOR RESEARCH AND THAT'S WHAT THE LAST LINE IS, IS PHENOPACKETS ON FHIR, WORKING WITH MELISSA--[AUDIO CUTS OUT ] AND HAVE A PLACE TO GO TO GET THESE TOOLS TO BE ABLE TO EXPORT DATA FROM CLINICAL CARE AND BRING IT INTO A RESEARCH OPERATION. THE NIBIB ALSO FUBDED IT SEVERAL SBIR INITIATIVES TO ENCOURAGE COMPANIES TO BUILD RESEARCH TOOLS SO WE CAN ACCELERATE THE USE OF STANDARDS PARTICULARLY FHIR BASE STANDARDS FOR CLINICAL RESEARCH. NEXT SLIDE, PLEASE. IN THE INSTITUTION WHERE THEY COULD BE LAYING DOWN IT COULD BE A FEDERAL HEALTH CENTER, PHYSICIAN'S PRACTICE OR CLINICAL TERMINOLOGIES ARE RUNNING IN THE BACKGROUND BEHIND THE CLINICAL SYSTEMS, WHAT WE WILL BE SPEAKING ABOUT FOR THE NEXT FEW MINUTES IS THE USCDI, WHICH IS THE U.S. CORE DATA FOR INTEROPERABILITY, THAT IS THE MINIMUM SET OF DATA EXPECTED TO BE PRESENT IN EVERY CLINICAL FACILITY AND EVERY CLINICAL RECORDS SYSTEM. FHIR IS THE MESSAGING STANDARD THAT HELPS TO TRANSLATE THAT CLINICAL INFORMATION INTO SOMETHING THAT CAN BE USEFUL FOR OTHER PURPOSES IN OUR CASE, IT WOULD BE USEFUL FOR THE RESEARCH RECORD. NEXT SLIDE, PLEASE. NOW THIS SLIDE IS A LITTLE BIT BIEWZY --BUSY AND WE WILL BE ABLE TO DISTRIBUTE THESE TO YOU, YOU SEE THEUS CORE DATA FOR INTEROPERATION 1. THIS IS A SET OF TERMS AND DATA AND STANDARDS THAT IS PRESENTED TO THE COUNTRY AFTER BEING AUTHORED BY U.S. HEALTHCARE TECHNOLOGY AND INTEROPERABILITY COMMISSION. THERE ARE SEVERAL DIFFERENT AREAS THAT ARE ADDRESSED. SO EVERY CLINICAL RECORD TO HAVE--TO BE CONSIDERED INTEROPERABILITY FOR OTHER RECORDS SHOULD HAVE INFORMATION ABOUT ACTIVITY, ALLERGY AND INTOLERANCE, ASSESSMENT AND PLAN OF TREATMENT, IDENTIFICATION OF THE TREATMENT, MEMBERS, CLINICAL NOTES AND PLEASE NOTE THIS IS A NEW PART OF THE STANDARD THAT SAYS WE WOULD EXPECT THE NARRATIVE AS WELL AS STRUCTURED NOTATION WOULD BE AVAILABLE, AND LISTS OF GOALS, HEALTH CONCERNS AND IMMUNIZATIONS, LABORATORY MEDICATIONS, I'M ON THE SECOND COLUMN, NOW THE THIRD COLUMN PATIENT PROBLEMS, PROCEDURES AND PROVIDENCE THAT EXTENDS ACROSS ALL OF THESE, I'LL COME BACK IN A MOMENT. SMOKING STATUS, UNIQUE IDENTIFIER FOR A PATIENT'S IMPLANTABLE DEVICE, SO FOR PATIENTS THAT HAVE A COCHLEAR IMPLANT OR MAYBE A NEW JOINT AND THEN A SET OF VITAL SIGNS. INTEROPERABILITY WAS COMMISSIONED THROUGH A COMMITTEE UNDER THE NATIONAL COORDINATOR FOR HEALTH IT AND RELEASED FOR PUBLIC COMMENT. IT HAS--IT WILL BE UPDATED EVERY YEAR BY--WITH INPUT TO THE COMMUNITY AND WE WILL COME BACK TO THAT BECAUSE THERE'S VERY SPECIAL THINGS I WILL BE TALKING TO THIS COMMUNITY ABOUT IN JUST A DPIEW MINUTES BUT WHAT I WANT YOU TO UNDERSTAND ABOUT THIS IS THE CONCEPT OF CORE DATA FOR INTEROPERABILITY OR A CORE DATA SET IS ESSENTIALLY A MINIMUM DATA SET THAT'S EXPECTED TO BE HELD ON ANY SINGLE PATIENT IN ANY SINGLE ELECTRONIC RECORD. AT THE BOTTOM OF THE SECOND COLUMN, THE INDICATION OF PROVIDENCE IS AN INDICATION OF WHERE AND WHEN EACH OF THESE DATA ELEMENTS WAS ENTERED. WE'LL RETURN TO THIS SLIDE IN A FEW MINUTES SO BE PREPARED TO COME BACK TO SLIDE 9 BUT LET'S GO TO SLIDE 10 AND 11 AND TALK ABOUT THESE FIRST. THE NIH IS ENCOURAGING ALL OF OUR CLINICAL PROGRAMS, THAT IS CLINICAL FACILITIES AROUND THE COUNTRY AS WELL AS RESEARCHERS TO ADOPT AND USE THIS STANDARDIZED SET OF DATA CLASSES, DATA ELEMENTS AND ASSOCIATED SOPHISTICATED CABULARY STANDARDS SPECIFIC IN THE USCDI AS A WAY TO ENCOURAGE INVESTIGATORS TO BE ABLE TO LEVERAGE CLINICAL DATA FOR THE PURPOSES OF RESEARCH AND BRING THAT DATA INTO THE CLINICAL--THE RESEARCH ACTIVITIES. [AUDIO CUTS OUT ] WE ARE READY SO THAT WE CAN ACCELERATE CLINICAL TRIALS AND MAKE THOSE CLINICAL TRIALS MORE REALISTIC, THAT IS MORE DEPENDENT ON CLINICAL CARE INFORMATION. THE USCDI DEFINES CODING SYSTEMS WHICH WE TALKED ABOUT EARLIER, THE TERMINOLOGIES, RX NORM, SNOMED AND LOINC, THAT ARE APPLICABLE TO ALL CLINICAL DATA EXCHAIMPLE STANDARDS, WHETHER IT'S HOSPITAL TO HOSPITAL, HOSPITAL TO NURSING HOME OR HOSPITAL TO RESEARCH FACILITY. IN THE CURES ACT FROM THIS SPRING, THERE IS A REQUIREMENT THAT CERTIFIED ELECTRONIC HEALTH RECORDS WE WERE SPEAKING OF EARLIER, MEANINGFUL USE ELECTRONIC RECORDS MUST ADOPT AND USE THESE USCDI VERSION 1 AND WE BELIEVE THAT BY ACTUALLY CARRYING THIS OUT WE WILL BE ABLE TO BE SURE THAT TO IMPROVE THE USE OF CLINICAL DATA IN THE COURSE OF RESEARCH. NEXT SLIDE. NOW WHEN I PRESENT ED TO THIS THE INSTITUTE OF DIRECTORS THERE WAS A LOT CONCERN ABOUT THE PARTICULAR NUANCED OR SPECIALIZED VARIABLES THAT MAY BE MISSING FROM A PARTICULAR GROUP. FOR EXAMPLE, THE--CAN WE RETURN TO SLIDE 9 FOR JUST A MOMENT, PLEASE? YOU'LL NOTICE THAT ALLERGIES AND INTOLERANCE HAS A LISTING FOR SUBSTANCE MEDICATION, SUBSTANCE DRUG CLASS AND REACTION, AND THEN ON THE UPPER RIGHT HAND SIDE, SMOKING STATUS. AND YET, ANY--THROUGHOUT THE REST OF THE SCREEN YOU SEE IN FRONT OF YOU, THERE'S NO SPECIFIC CALL OUT FOR SUBSTANCE USE, SUBSTANCE MISUSE, VAPING, NICOTINE DELIVERY THROUGH VAPING, PRESCRIPTION DRUG USE AND OUR BOTH NIDA, DIRECTOR OF NIDA AND DIRECTOR OF THE NIAAA, SAYS IT'S ESSENTIAL TO HAVE A CLINICAL RECORD OF THIS ELEMENT OF MORE DETAILED INFORMATION ABOUT THE SUBSIDIARY STANCE USE AND SUBSTANCE MISUSE PROBLEMS. IF WE CAN GO BACK TO SLIDE 12, THEN. I WANT TO TALK TO YOU JUST A BIT ABOUT HOW 1 GOES ABOUT GETTING THE USCDI ENRICHED BY DATA THAT ARE RELEVANT TO A PARTICULAR COMMUNITY AND THE NIAMS COMMUNITY UNDERSTANDING FUNCTION, SKIN STATUS AND MUSCULOSKELETAL DISEASES IN A WAY THAT NO OTHER COMMUNITY UNDERSTADS. SO YOUR COMMUNITY MAY BE INTERESTED IN ENRICHING THE USCDI WITH EVIDENCE OR WITH TERMINOLOGIES OR WITH MEASUREMENTS THAT ARE SPECIFIC TO SKELETAL OR MUSCULOSKELETAL AND FUNCTION. THE WAY 1 DOES THAT IS BY REACHING OUT TO THE INTEROPERABILITY STANDARDS THAT THE OFFICE OF THE NATIONAL COORDINATOR USES TO INCLIEWTD NEW TERMINOLOGIES, RECOGNIZE INTEROPERABILITY STANDARDS THAT CAN BE A VALUE ACROSS THE CLINICAL AREAS. THE WEBSITE IS ON THE BOTTOM RIGHT HAND SIDE, H TTPS//WWW.HEALTHIT.GOV/ISA/. SHOULD YOUR COMMUNITY OR COLLEAGUES BE ADDING TERMINOLOGY INTO THE USCDI, THIS IS THE PATHWAY THEY WOULD GO. THEY WOULD APPROACH--USUALLY IT COMES THROUGH A RECOGNIZED TEAM, RECOGNIZED CLINICAL BODY PRESENTS A NEW SETY OF TERMS OR A NEW--SET OF TERMS OR NEW STANDARD OR MEASURE TO THE ISA, IF GOES OUT FOR PUBLIC, IF IT'S SUFFICIENT PUBLIC COMMENT IT GETS ENDORSED AND ADDED TO THE USCKI. SO THERE IS A SYSTEM TO MODIFY WHAT IS CURRENT AND MORE RELEVANT OR TO ADD THINGS THAT ARE MORE RELEVANT TO YOUR COMMUNITY. I WANT TO CLOSE BY TALKING ABOUT COMMON DATA ELEMENTS WHICH IS A SLIGHTLY DIFFERENT FORM OF THE--OF THE FORMAL TERMINOLOGIES AND ALSO ABOUT THE VALUE SETS. CAN I GO TO THE NEXT SLIDE, PLEASE? COMMON DATA ELEMENTS HAVE GOTTEN A LOT OF INTEREST IN THE LAST FEW YEARS. IT'S A SINGLE ITEM INDICATOR OR MULTIITEM SCALE THAT MEASURES THE SAME CONCEPT ACROSS DIFFERENT STUDIES, I WILL GIVE AN EXAMPLE OF THE CONCEPT OF DEPRESSION WHICH COULD BE MEASURED BY THE DEPRESSION INVENTORY, BY THE PHQ9, BY THE CESD, OR BY SELF-REPORT OF AN INDIVIDUAL DESCRIBING THEIR OWN MOOD STATE. THE PURPOSE OF COMMON DATA ELEMENT SYSTEM TO MAKE SURE THAT RESEARCH COLLECTED VARIABLES CAN BE SHARED OR BECOME INTEROPERABLE ACROSS RESEARCH PROGRAMS. SOMETIMES THESE ORIGINATE IN CLINICAL DATA, SOMETIMES THEY ARE NIQUE AND INITIATED UNDER SPECIFIC RESEARCH PROGRAM. THE NIH HAS INITIATED A COMMON DATA ELEMENT REPOSITORY THAT PROVIDES ACCESS TO STRUCTURED HUMAN AND MACHINE READABLE DEFINITIONS OF DATA ELEMENTS THAT HAVE BEEN RECOMMENDED OR REQUIRED BY NIH INSTITUTES AND CENTERS AND OTHER RESEARCH ORGANIZATIONS FOR USE IN RESEARCH AND FOR OTHER PURPOSES. LET ME GIVE YOU 2 EXAMPLES OF THESE. NEXT SLIDE, PLEASE. --FOR RACE AND ETHNICITY SHOULD BE MEASURED. THIS IS REQUIRED ON ALL NIH STUDIES, WHAT THE NIH IS PROPOSING IS REQUIRING, EXCUSE ME, OR THE 2 QUESTIONS YOU SEE ON THE SCREEN IN FRONT OF YOU IS THE REFERENCE PERSON AND THAT'S REFERRED TO AS PERSON 1 HERE OF HISPANIC LATINO OR SPANISH ORIGIN AND THEN THERE ARE SEVERAL OPTIONS IN RESPONSE. WHAT IS THIS PERSON'S RACE AND MARK 1 OR MORE BOX AND YOU CAN PRINT THE ORIGINS. HERE TO COLLECT COMMON WAY--BRACK AUDIO CUTS OUT ] INCLUDING TO DEMONSTRATE THAT OUR EXPRCH REACHING INTO AND RESPONDING TO COMMUNITIES OF INTEREST, AND ALSO DOCUMENT THE PARTICIPATION AND RESEARCH STUDIES AND IMPORTANTLY TO BE ABLE TO BE SURE OUR RESEARCH IS AADDRESSING THE CONCERNS OF DIFFERENT GROUPS. NOW, THESE 2 QUESTIONS ARE FAIRLY STRAIGHT FORWARD BUT I WILL TELL YOU UP UNTIL ABOUT A YEAR AND A HALF AGO, WITHIN THE NIESHES H CVE REPOSITORY THERE WERE 71 DIFFERENT WAYS TO MEASURE RACE AND ETHNICITY. INCLUDING THE 1 ADVANCED BY THE OFFICE OF MANAGEMENT AND BUDGET INCLUDING DIFFERENT SELF-IDENTIFIED WAYS THAT INVESTIGATORS PROPOSED AS BEING MORE SOUND OR MORE VALID, THE CHALLENGE OF COMING UP WITH COMMON DATA ELEMENTS IS COMING TO SOME AGREEMENT ACROSS A DISCIPLINARY GROUP. THE MEASURE IS VALID, RELIABLE AND APPROPRIATE FOR THIS PARTICULAR PHENOMENON. NEXT SLIDE, PLEASE. AS I IBDICATED IN THE BEGINNING, DEPRESSION IS 1 OF THE ELEMENTS THAT WE DO NEED TO MEASURE IN SOME KIND OF A COMMON WAY IF SOMETHING MORE TO BE ABLE TO CROSS MAP BETWEEN A MEASURE OF DEPRESSION UNDER THE PHQ9 AND 1 UNDER THE MEASURE OF THE DEPRESSION INVENTOR SOY WE CAN LOOK FOR EQUIVALENTS ACROSS STUDIES. IF 1 GOES TO THE CDE REPOSITORY 1 WOULD FIND THIS PARTICULAR MEASURE FOR DEPRESSION, THIS IS THE PHQ9 AND THE QUESTIONS AND THE ACCEPTABLE ANSWERS ARE THERE. FUNDAMENTALLY A COMMON DATA ELEMENT IS THE REPRESENTATION OF A CONCEPT THROUGH A QUESTION AND ANSWER SET AND RIGHT NOW WE HAVE, AT THE NIH OVER SEVERAL THOUSAND DIFFERENT COMMON DATA ELEMENTS AS WE MOVE INTO THIS PERIOD OF TIME FOR STUDYING COVID-19 AND THE PATIENT'S EXPERIENCE AND SEQUELA OF COVID-19 WE ARE TRYING TO CLUSTER THOSE INTO SPECIFIC RECOMMENDED SETS SO IF AN INVESTIGATOR IS READY TO TEST COMMON DATA ELEMENTS OR TESTS INTERVENTION FOR COVID, THEY'RE ABLE TO DESCRIBE THE PHENOMENON IN A COMMON WAY. MY LAST STRUCTURED APPROACH TO DATA, I'LL SPEAK YOU TO ABOUT IS THE VALUE SETS. PLEASE'RE NEXT SLIDE, PLEASE. IN A VALUE SET, A PROFESSIONAL SOCIETY GROUP HAS PROPOSED A PARTICULAR SET OF CODES OR INDICATORS THAT ARE--THAT ARE EXPECTED TO BE USED TO CHARACTERIZE A SPECIFIC PROBLEM. THE NLM HOSTS THE VALUE SET OF AUTHORITY THAT HAS WE PROVIDE THE REFERENCE SET SO THAT ONCE A PROFESSIONAL GROUP HAS IDENTIFIED A CLUSTER OFICISM OF-- SYMPTOMS THAT ARE INDICATIVE OF A PARTICULAR PHENOMENON, WE HAVE A PLACE WHERE THAT CAN BE STORED AND IN FACT THIS CAN BE READ ELECTRONICALLY BY COMPUTER AND ELECTRONIC HEALTH RECORD SYSTEMS SO WE SUPPORT THE CONSTANT FLEE AND MEASUREMENT OF THIS. RIGHT NOW IN THIS SCREEN IN FRONT OF YOU, YOU SEE THE CODES WE'VE BEGUN TO USE TO IDENTIFY THE COVID-19 UP UNTIL JANUARY OF THIS YEAR, WE DID NOT HAVE ANY VALUE SETS THAT INDICATED HOW 1 WOULD DETERMINE IN A PATIENT WAS TRULY BEING CARED FOR FOR COVID-19. AND AS MANY OF YOU KNOW, WE HAVE PATIENTS WHO ARE SYMPTOMATIC BUT SCR A NEGATIVE TEST, OTHERS HAVE A POSITIVE TEST BUT ARE ASYMPTOMATIC AND SO MAKING THE DIAGNOSE FOR COVID-19 IS NOT STRAIGHT FORWARD. IF AN INSTITUTION NEEDS TO DEMONSTRATE THEY ARE CARING FOR PATIENTS WITH THIS DIAGNOSE AND APPROPRIATELY COMPENSATED, THE VALUE SETS PROVIDE A WAY, REFERENCED STRUCTURE SO THAT THE BILLING, CLINICAL CARE AND QUALITY MEASURING CAN BE COLONEL PLETELY ALIGNED. LAST SLIDE I PROMISE. NEXT SLIDE, PLEASE, I'VE COVERED A LOT OF MATERIAL AND WHAT I WANTED TO LEAVE YOU WITH IS A COUPLE OF MESSAGES. FIRST AND FOREMOST, WITHIN THE U.S. CORE DATA FOR INTEROPERABILITY, IF THERE IS--IF THERE IS A NEED TO REPRESENT PHENOMENON THAT YOUR COMMUNITY IS MOST INTERESTED IN, PLEASE TAKE ADVANTAGE OF WORKING WITH THE INTEROPERABILITY STANDARDS ADVISORY PROCESS. IN ADDITION THOUGH, WE ASKED AS NIAMS GOES FORWARD WITH NEW INITIATIVES THAT THE LANGUAGE RELATED TO LEVERAGING THE USCDI FOR RESEARCH SHOULD BE INCLUDE HAD IN ALL NOTICES OF SPECIAL INTERESTS AND FUNDING OPPORTUNITY ANNOUNCEMENTS. WE ENCOURAGE YOU TO MAKE YOUR INVESTIGATORS AWARE OF AND MAKE USE OF THE USCDI TO AID IN BOTH GETTING BETTER CLINICAL DATA FOR--[AUDIO CUTS OUT ]--WE ENCOURAGE AS NIH BEGINS TO LAUNCH DATA MANAGEMENT AND SHARING PLANS WE ENCOURAGE THAT THOSE PLANS SPECIFICALLY MAKE REFERENCE TO THE USCDI AND OTHER STANDARDS STRATEGIES AND THEN AS WE BEGIN TO SET UP REPOSITORIES THAT IS RESEARCH DATA THAT CAN BE REUSED, PROPERLY APPROVED FOR OTHER STUDIES THAT THE CDI AND OTHER STANDARDS BECOME THE BASIS FOR ESTABLISHING THOSE REPOSITORY. AND FINALLY WE ENCOURAGE YOUR PROGRAM OFFICERS TO CONSIDER THIS MATERIAL AS A WAY TO DEVELOP AND FUNDING OPPORTUNITIESA, NOUNSMENTS AND TO EVALUATE THEIR PROPOSALS. THAT CONCLUDES MY FORMAL REMARKS. I HAVE TAKEN YOU THROUGH A VERY QUICK TOUR OF WHAT IS TURNING OUT TO BE A REALLY CRITICAL RESEARCH TOOL MAKING SURE THAT DATA ARE FINDABLE, INTEROPERABILITY, SHAREABLE AND REUSABLE. THANKS VERY MUCH FOR THE TIME, BOB AND I THINK I LEFT SOME TIME FOR QUESTIONS. >> THANK YOU, THATS WAS MAGNIFICENT, THAT IS THE POINT OF WHY YOU ARE HERE TODAY. WE REALLY APPRECIATE IT. I HOPE THAT PEOPLE--THE COUNCIL OR ANYBODY DOES CLINICAL RESEARCH PROBABLY HAS QUESTIONS AND THAT INCLUDES NOT JUST COUNCIL BUT EVERYBODY ON THE VIDEOCAST SO I'M SURE WE WILL HEAR ABOUT THIS BUT I DO WANT TO PERSPECTIVE, THIS IS THE THING THAT NIAMS SHOULD DO EVERYTHING WE CAN TO PROMOTE, INCLUDING REQUIRING IT IN THE NOTICES AND IN THE FUNDING OPPORTUNITIES BECAUSE AS ANYBODY WHO DOES CLINICAL RESEARCH KNOWS, THAT ABILITY TO GET DATA IS THE HEART AND BLOOD OF HUMAN STUDY. AND IF WE CAN DO IT IN SUCH A WAY THAT HAS THE DATA ELEMENTS THAT WE NEED, SURE WE CAN ALSO THINK OF THING SAYS WE WOULD LIKE--THINGS WE WOULD LIKE TO ADD BUT THIS IS TERRIFICALLY IMPORTANT. SO WITH THAT LET'S TURN TO SEE WHO MIGHT HAVE ANY QUESTIONS. >> I HAVE A QUESTION. >> THIS IS JILL, CAN I-- >> YES. >> JILL, WITH NYU, THIS IS PROBABLY THE MOST IMPORTANT AREA FOR CLINICAL RESEARCH THAT EXISTS BUT THE ELEPHANT IN THE ROOM WHICH WE REALLY DO NEED TO STRUGGLE WITH IS WHAT WOULD THESE ELECTRONIC SYSTEMS REALLY USE FOR ORIGINALLY OF COURSE WAS BILLING PURPOSES AND I THINK TO BALANCE BILLING CHALLENGES VERSUS QUALITY AND RESEARCH IS THE UTMOST ELEPHANT IN THE ROOM AND JUST EVEN AS AN EXAMPLE, WE AS DIRECTORS OF DIVISIONS HAVE TO DEAL WITH RBUs, TIME COMMITMENTS PER PHYSICIAN, WHO ENTERS THIS INCREDIBLE COMPLEX DATA AND EVEN IF YOU LOOK AT ICD CODES FOR LUPUS THERE ARE ABOUT 30, NONE OF WHICH MAKE ANY SENSE. WE DON'T INCORPORATE CRITERIA BEAUSE NO 1 WOULD HAVE TIME TO DO THAT. SO HOW DO WE RECONCILE THE QUALITY NEEDED FOR RESEARCH VERSUS GETTING THE JOB DONE AND MAKING IT BILLABLE FOR THE INSTITUTION. I MEAN, THAT TO ME IS TOUGH. >> THAT'S A VERY FAIR QUESTION AND IS A VERY APPROPRIATE QUESTION THAT REQUIRES A NUMBER OF PEOPLE TO PARTICIPATE IN THE ANSWER FOR. SO LET ME BEGIN BY THAT AND I'M SURE THERE MAY BE OTHER SUGGESTIONS, THE FIRST 1 IS I'M PERSONALLY, I'M A NURSE AND INDUSTRIAL ENGINEER I'M NOT A PHYSICIAN AND THE LAST TIME I WAS IN CLINICAL CARE WAS IN 1979. SO IT WAS A LONG TIME AGO. SO WHAT I WILL TELL YOU IS THAT MY ENTIRE RESEARCH CAREER HAS FOCUSED ON PATIENT PARTICIPATION AND RESEARCH AND THEIR CARE AND WHAT I WILL SAY IS IF WE REQUIRE ALL OF THAT INFORMATION TO BE GATHEREDDA THE MOMENT OF THE SINGLE SHORT PHYSICAL ENCOUNTER WITH THE PATIENT IN THE ROOM, WE WILL KILL OUR CLINICIANS, TELL BE EXHAUSTING AND MORE COMPLEX AND COGNITIVELY DAMAGING THAN WE WANT IT TO BE. SO WHAT BECOMES CRITICAL IS TO THINK ABOUT THE INFORMATION AND FLOW ACROSS THE PATIENT, EXPERIENCE OF CARE AS OPPOSE TO THE SINGLE EPISODE OF CARE AND WE NEED TO BEGIN TO RELY ON PATIENT SELF-REPORT, VALIDATED SELF-REPORTS AND FIND WAYS TO GATHER INFORMATION IN A WAY THAT SUPPORTS THE USE OF THAT INFORMATION BY OUR CLINICIANS AND REMOVES OUR CLINICIANS FROM BEING THE TRANSCRIBERS AND TRANSCRIPTIONISTS. NOW, SOME OF THAT HAS TO DO WITH PROFESSIONAL PRACTICE AND INSTITUTIONS, SOME OF THAT DOES HAVE TO DO WITH THE FACT THAT WE HAVE PRETTY PERVERSE INCENTIVES AND OUR CLINICAL RECORDS SYSTEMS ORIGINALLY AS CREATED BOTH GROW OUT OF THE BILLING SYSTEM AND THE IDEA BEING IF WE COULD COUNT EVERY PIECE OF CARE WE GAVE, WE CAN PROPERLY BE COMPENSATED FOR IT AND FRANKLY WERE INITIALLY BUILT TO REASSURE THE CLINICIAN THAT IT WOULDN'T LOOK ANY DIFFERENT THAN THE PATIENT CHART. BUT IN FACT--[AUDIO CUTS OUT ]--REALLY DO HAVE TO OPERATE DIFFERENTLY. I HAVE SOME CONFIDENCE THAT THE RECORD SYSTEMS ARE IMPROVING. I HAVE A LITTLE LESS CONFIDENCE THAT WE'VE YET GOTTEN THE RIGHT ENGINEERING OF THE INFORMATION OF FLOW IN THE CLINICAL CARE EXPERIENCED BUT I THINK THE PRACTICES SESES OF ENGAGING PEOPLE IN PRE-VISIT PLANNING [AUDIO CUTS OUT ] RATHER THAN PROVIDERS OF CONTEXT, I WOULD BE VERY INTERESTED IN HEARING SOME OF THE OTHER INTERESTS IN THIS GROUP, WE ARE HAPPY TO TALK WITH YOU OFFLINE ABOUT SOME OF THE THINGS THE NLM IS DOING TO ACCELERATE PATIENT LEVEL TO ENGAGE WITH THEIR INFORMATION? >> I'M MIKE, I'LL ALSO A DIVISION CHIEF OF ENDOCRINOLOGY AND IN OUR GROUP, WE KNOW EVERY MINUTE THAT SOMEONE'S ON THE EMR, IT'S SLIGHTLY EVERY 30 MINUTES PER PATIENT FOR PHYSICIAN TIME WHICH IS ASTOUNDING CONSIDERING A REGULAR VISIT AND 20 MINUTES AND WE REALLY HAVE TO BE CAREFUL THIS ISN'T [INDISCERNIBLE] BECAUSE THIS IS EMRs ARE REALLY HURTING PHYSICIAN WELLNESS, PARTICULARLY IN THE ENM FIELDS OF ENDOCRINOLOGY AND [INDISCERNIBLE] FOR EXAMPLE. SO ANY ADDITIONAL BURDEN PLACED ON THE CLINICIAN AND THE CLINICAL RESOURCE IS REALLY UNWELCOME. >> SO 1 OF THE THINGS THAT WE--IT IS HOPED BY THE USE OF THE CORE DATA FOR INTEROPERABILITY IS THAT THERE CAN BE GREATER REUSE OF CLINICAL INFORMATION AND THAT REQUIRES BOTH A TECHNICAL CHANGE AS WELL AS SOCIOLOGICAL LOGICAL CHANGE. TRUSTING THE INFORMATION TO SLOW DOWN THE CHAIN, MOVING OURSELVES AWAY FROM REPEATED REPLACING OF THE SAME DATA BECAUSE WE'RE WORKING FOR CONFIRMATION SO WE HAVE A PARTICULAR WAY OF HEARING IT IS 1 CHOICE. THE SECOND THING IS I CALL ON OUR EDUCATORS IN THE COMMUNITY TO REACH INTO YOUR TRAINING PROGRAMS. HOW WE TREAT--HOW WE TEACH INDIVIDUALS ABOUT HOW TO USE INFORMATION IN THE PROCESS OF CLINICAL CARE. OFTEN WHEN THERE'S AN INFORMATICS COURSE, I WILL ASK PEOPLE TO GO ON MUTE BECAUSE I'M GETTING A LOT OF FEEDBACK, OFTEN WHEN THERE'S A CLINICAL INFORMATICS COURSE OFFERED TO MEDICAL STUDENTS IT OFTEN TEACHES THEM HOW TO DO LIBRARY SEARCHING, THAT'S NOT ENOUGH. WE HAVE TO TEACH THEM HOW TO BECOME EFFECTIVE USERS OF INFORMATION TO THE POINT OF NEED AND WE ALSO HAVE TO FIGURE OUT WAYS TO BUILD TRUST AND INFORMATION THAT'S PRESENTED. THIS WILL NOT HAPPEN WITH A 2000 PAGE CHART HANDED TO A BUSY CLINICIAN IN AN ER, WE GET THAT, SO BUILDING TOOLS FROM NEVERL LANGUAGE PROCESSING, WORK LIKE [INDISCERNIBLE] IS DOING AT HARVARD TO TRY TO CREATE TIME SERIES OF PATIENTS. THAT IS HERE'S THE TIME TRAJECTORY SUMMARY OF THIS PATIENT'S RECORD SO WE CAN USE ARTIFICIAL INTELLIGENCE TECHNIQUES TO IMPLEMENT THINKING OPPOSE TO MAKE THE CLINICIAN BE THE FERITER OF INFORMATION AND THE FINDER OF INFORMATION IS REALLY VERY CRITICAL. I WOULD ALSO BE A LITTLE REMISS IF I DIDN'T COMMENT SLIGHTLY ON OUR SIGNIFICANT ADJUDICATION. OUR LEGISLATIVE SYSTEM, OUR LEGAL MEDICAL SYSTEM HAS PUT US IN A MODE WHERE ACQUIRING INFORMATION AS A PROTECTIVE DEVICE IS BECOME SOMETHING OF THE NORM. THANK YOU. >> GO AHEAD. >> SORRY. >> JUDITH,. >> SO PATTY THIS WAS A GREAT TALK AND I COMPLETELY AND TOTALLY AGREE WITH JILL, THAT THIS IS EXTREMELY IMPORTANT. WHAT I WORRY ABOUT IS THAT SO I'M FROM OKLAHOMA--SORRY JUDITH JAIMS FROM OKLAHOMA, AND SO THAT WE TAKE CARE OF A LOT OF RURAL PATIENTS AND PATIENTS IN THE INDIAN HEALTH SYSTEM, SO I CAN SEE EPIC AND OTHERS REALLY, REALLY BIG ELECTRONIC MEDICAL RECORDS MAKING INVESTMENTS IN TRYING TO DO THIS BUT WHAT I'M WORRIED ABOUT IS WHAT ABOUT A SIGNIFICANT PART OF OUR CALCULATION, A LOT OF PEOPLE WHO ARE UNDER SERVED, UNDERINSURE THAD WE NEED TO HAVE DATA ABOUT. HOW ARE WE GOING TO GET THAT DATA TO A POINT THAT WE CAN REUSE IT. >> YOU KNOW JUDITH, IT'S NICE TO YOU SEE YOU BOO I THE WAY AND I--BY THE WAY AND I APPRECIATE THE QUESTION. BECAUSE REALLY WE'RE TALKING ABOUT MOVING FROM A ONE-SIZE-FITS-ALL MODEL OF INFORMATION TO ACTUALLY LOOKING AT INFORMATION IN CONTEXT. ONE OF THE SIDE BENEFITS IS COVID, I HAVE TO SAY IS THAT WE ARE LOOKING AT HOW 1 CONNECTS PUBLIC HEALTH INFORMATION, ENVIRONMENTAL HEALTH INFORMATION AND PERSONAL HEALTH INFORMATION AND SO I BELIEVE WE WILL SEE NEW MODELS COMING FORWARD BUT IT WILL REQUIRE BRINGING--[AUDIO CUTS OUT ]--DIFFERENT WAY OF INCENTIVIZING PRACTICES BECAUSE WE MUST GET TIME FOR OUR PHYSICIANS TO DO THE PRACTICE, NOT JUST SIMPLY RECORD THE PRACTICE. >> AND THEN THE OTHER ISSUE WAS COSTS, RIGHT? BECAUSE I'VE DONE A LOT OF DATA CLEAN UP AND A LOT OF TRYING TO MINE DATA, RIGHT? AND THEN I MAKE THIS BEAUTIFUL DATA SET AND THEN LOTSS OF PEOPLE CAN REMINE IT AND THEY DON'T HAVE THE INIT COST AND I HAVE TO ADMIT THE STUDY SECTION IS NOT EXCITED ABOUT DATA CLEAN UP AS A SPECIFIC AIM SO ANY-- >> SO A COUPLE THINGS ARE COMING DOWN. WE HEAR YOU. FIRST OF ALL DATA WHAT WE CALL DATA HYGIENE OR DATA CURATION HAS TO BEGIN AT THE BEGINNING OF THE RESEARCH PROJECT, IT CAN'T BE AS THE POST DOC IS GOING OUT THE DOOR TO HER NEW JOB OR AS THE TENURE CASES PUT TOGETHER. SO WE'RE TRYING TO SOCIALIZE AND FRANKLY PUT TOOLS INTO THE RESEARCH PROCESS INCLUDING THE DATA MANAGEMENT AND SHARING PLAN THAT WILL ACTUALLY PUT THIS UP FRONT IN THE RESEARCH PROCESS, SECONDLY NIH REALIZES THAT YOU CAN'T SIMPLY HIDE RESEARCH CURATION DATA COSTS UNDER AN RO1. IT HAS TO BE CALLED OUT EXPLICITLY SO I WOULD CALL YOUR ATTENTION TO A MODEL PROJECT THAT'S STARTED AT THE NIMH BUT IS SPREADING SOMEWHAT RAPIDLY ACROSS THE ENTIRE OF NIH AND THAT IS TO INCLUDE DIRECT COSTS FOR DATA CURATION AND NIMH HAS A WONDERFUL SPREADSHEET THAT JUST HELPS YOU WORK OUT WHAT COSTS DO YOU ANTICIPATE. IT IS POSSIBLE TO PUT DIRECT COSTS INTO A GRANT NOW AND THAT'S REALLY IMPORTANT. POINT NUMBER 3 IS WE ARE BEGINNING TO RELEASE, AND I BELIEVE IT'S THIS FALL U54S THAT WILL BE DATA RESOURCE GRANTS AND THESE WILL BE RESEARCH GRANTS--I'M SORRY, THESE WILL BE NONRESEARCH GRANTS, RESOURCE GRANTS THAT FOCUS ON THE DEVELOPMENT AND REUSE OF DATA. UNDER THE AIBLE WHICH IS ARTIFICIAL INTELLIGENCE FOR BIOMEDICAL RESEARCH, JUST RELEASED THIS SPRING, WE ARE FOCUSING ON CREATING DATA SETS THAT ARE ANALYTICALLY READY. THIS IS A VERY DIFFERENT MODEL OF CREATING DATA SETS AND I WILL BE HAPPY TO TALK WITH COUNCIL AT SOME OTHER TIME ABOUT THE ALE PROGRAM OR SPEAK WITH YOU ABOUT IT, IT REALLY WILL BRIDGE NEW DATA SETS INTO USEFULNESS BUT LIKE DR. JAMES INDICATED WE EXPEND SO MUCH MONEY COLLECTING DATA SO FAR AND WHILE LIKE THE PICTURES OF OUR COMRN, NOT EVERY PIECE OF DATA IS AS BEAUTIFUL AS WE THINK IT IS, MUCH OF IT IS VALUABLE. SO THE NLM IS INVESTING IN PROGRAMS SUCH AS COMPUTATIONAL APPROACHES TO CURATION AT SCALE THAT WILL ALLOW US TO TAKE A LOOK AT AND APPRAISE QUANTITATIVELY, THE INTEGRITY OF THESE DATA SETS AND TO PROVIDE--PROVIDE A MECHANISM FOR MAKING USE OF DATA ONCE COLLECTED, EVEN IF IT'S IMPERFECT AND TO KNOW WHERE IT CAN AND CANNOT BE USE INDEED FUTURE MODELS. >> KAREN QUICK QUESTION? >> NO, THIS IS KAREN [INDISCERNIBLE] WITH THE WEBER FOUNDATION, I ABSOLUTELY ABSORBED THE WHOLE THING YOU SAID, I WAS SO EXCITED BY IT BECAUSE FOR YEARS I HAVE BEEN PUSHING THAT THE PATIENT VOICE AND 1 THAT DOES NEED TO BE HEARD WHETHER IT'S IMPERFECTLY STATED OR WHATEVER, SO AS YOU WERE TALKING IT WAS 1. THINGS I THOUGHT WAS WE AS ADVOCACY ORGANIZATIONS NEED TO BE BEGIN TO ASSESS OUR PATIENT SOPHISTICATION MUCH AS JUDITH WAS SAYING WITH HER POPULATION SO WE FROM OUR PERSPECTIVE NEED TO BEGIN TO DO A SERIES OF YOU KNOW WEBINARS, PODCASTS, WHATEVER AND AS WE'RE DEVELOPING OUR 26 CENTERS OF EXCELLENCE AROUND THE COUNTRY, TRYING TO FIGURE OUT THE BEST WAY TO PUT THEIR COLLECTIVE DATA ON [INDISCERNIBLE] WEBER TOGETHER, SO IT IS MEANINGFUL. YOUR POINT ABOUT TEACHING THEM HOW TO USE THE INFO IN THEIR CLINICAL CARE SETTING IS IMPORTANT, I THINK FROM THE PATIENT AND THE CARE PROVIDER STANDPOINT. SO THANK YOU VERY MUCH, I'M VERY EXCITED BY IT. >> THANK YOU SO MUCH, LET ME LEAVE YOU WITH 2 THOUGHTS. THE FIRST IS THE NATIONAL LIBRARY OF MEDICINE RECENTLY SPONSORED A REPORT THAT WAS RELEASED THIS SUMMER CALLED SUSTAINABILITY OF DATA RESOURCES AND IT WAS INTENDED TO PROVIDE A GUIDE POST TO PLAN THESE LARGE DATA RESOURCES IN 3 STAGES DURING THE ACTIVE PROGRAM, DURING THE PROGRAM WHERE THE DATA CAN BE REDUCED AND ARE STILL ACTIVELY USED AND THE STUDY IS OVER AND THEN FINALLY IN THE COLD STORAGE STAGE AND SO I URGE YOU TO LOOK AT THE NIAMS REPORT, I'LL SEND THE LISTEN TO BOB SO YOUR OFFICE HAS IT. AND THE SECOND IS THAT I WANT TO REMIND YOU THAT THE ISSUES OF SHARING DATA HAVE TO DO WITH THIS DISCOVERY AND THIS IS A SEAT CHANGE FROM THINKING ABOUT DISCOVERY BECAUSE THAT WILL REQUIRE OUR STUDY SECTIONS AND OUR SCIENTISTS REALLY THINK ABOUT NEW WAYS OF BUILD BEING KNOWLEDGE. I THANK YOU FOR YOUR TIME AND INTEREST, PARTICULARLY IN YOUR INTEREST IN TAKING THESE THOUGHTS FORWARD, HAPPY TO SPEAK WITH Y'ALL AFTER AND I'LL SEND YOU--[AUDIO CUTS OUT ] >> THANK YOU PATTY, VERY IMPORTANT, STIMULATED A LOT OF THINKING AND WORK TO BE DONE BUT I WANT TO REITERATE MY COMMITMENT TO FURTHERING SO THAT WE CAN SHARE USEABLE IMPORTANT DATA. SO THANKS AND ENJOY YOUR LEAVE. >> I WANT TO LEAVE MY FINAL THOUGHT OF THIS MEETING IS TO [INDISCERNIBLE] IN HIS ROLE FIRST AS DEPUTY AND NOW AS ACTING DIRECTOR, SMART, SHARP MAN WHO SPEAKS ON MANY SUBJECTS SO WELL AT THE IC DIRECTORS MEETING, I WILL MISS YOUR VOICE A LOT AND I HOPE WE CONTINUE TO GET TO WORK TOGETHER. THANK YOU. >> THANKS, PATTY, WE HAVE WORK TO DO. [LAUGHTER] AND WELCOME TO LINDSAY, YOU WILL ENJOY PATTY, I PROMISE YOU. THANKS AND WITH THAT WE WILL MOVE ON. SO THE NEXT IS LESSONS LEARNED SO DR. SZTEIN, TO THE WORKING GROUP PREVIOUSLY, TODAY WILL BE AN UPDATE REPORT TO FOLLOW WITH A SUBSEQUENT MEETING AND I WOULD LIKE TO THANK SUSAN FOR HER LEADERSHIP IN THIS EFFORT AND ALL THE MEMBERS OF THE WORKING GROUP WHICH INCLUDES POOEM HERE TODAY FOR THE CONTRIBUTIONS. THIS HAS BEEN A SUBSTANTIAL EFFORT. BUT MEMBERS OF COUNCIL ARE PARTICULARLY INVITED TO PROVIDING FEEDBACK AT THIS STAGE AT THE INTERIM REPORT BEFORE THE FINAL VERSION, SO THOSE ARE QUESTIONS ABOUT SOME OF THE RECOMMENDATIONS THAT SUZANNE OUTLINES TOWARDS THE END OF OUR PRESENTATION OR ITEMS THAT COUNCIL SHOULD BE CONSIDERED BOO ON THE WORKING GROUP MIGHT KILL- YOU BUT THIS IS THE TIME TO BRING IT UP. SO WITH THAT TURN IT TO SUZANNEA. >> THANK YOU BOB. GOOD MORNING, EVERYONE. AND AS BOB MENTIONED, WE FIRST NEED TO ACKNOWLEDGE SEVERAL MEMBERS OF OUR COUNCIL WHO ARE PARTICIPATING IN THE WORKING GROUP THAT IS CONDUCTING AN ASSESSMENT OF THE LESSONS LEARNED IN THE AMP EFFORT. WE ALSO HAVE MEMBERS EVER COUNCIL DR. NATHAN WHO IS AN INVESTIGATOR PARTICIPATING IN THE WORK, I DON'T KNOW IF DR. CRISWELL IS STILL ON THE LINE BUT DR. CRISWELL HAS ALSO BEEN A MEMBER OF THE LESSONS LEARNED WORKING GROUP. SO THANK YOU ALL FOR PARTICIPATING BOTH IN THE PROJECT AND IN THE WORKING GROUP. YOUR CONTRIBUTIONS ARE TREMENDOUS AND WE ARE VERY APPRECIATIVE OF THEM. >> SO TODAY I'M GOING TO TALK A LITTLE BIT ABOUT THE ACCELERATING MEDICINE PARTNERSHIP, THE UMBRELLA PARTNERSHIP PROJECT AND THE AMP, COMPONENT OF AMP THAT NIMS HAS BEEN LEADING IN MANAGING OVER LEADING OVER THE LAST 6 YEARS AND THEN WE WILL MOVE ON TO THE--SOME ASPECTS OF THE EVALUATION THAT WE'VE BEEN CONDUCTING AND FINALLY, I WILL END WITH 2 SLIDES WITH THE NEXT STEPS FOR RA LUPUS. SO IN THE NEXT SLIDE, THANK YOU, YOU CAN SEE SOME OF THE FEATURES OF THE ACCELERATING MEDICINES PARTNERSHIP, IT IS AN UMBRELLA STRATEGIC BIOMEDICAL INITIATIVE THAT THE NIH LAUNCH IN 2014 TO ADDRESS THE CHALLENGE OF THE NARROWING AND INEFFECTUAL PIPELINE FOR DIRECT DEVELOPMENT. IT IS IMPRESSIVE IN TERMS OF PARTNERSHIP WITH THE COMPANIES, PHARMACEUTICAL COMPANIES AND LIFE SCIENCES COMPANIES PARTICIPATING TOGETHER WITH THE NOT FOR PROFIT ORGANIZATION AND ACADEMITIONS AGREE TO WORK TOGETHER IN A COMPETITIVE SPACE AND AN AGENDA TO DEVELOP TOGETHER AND THE FUNDING IS SHARED BY THE NIH AND BY THE COMPANIES. ONE OF THE FEATURES OF THE AMP THAT MAKES IT SO SUCCESSFUL IS THE DEEP COMMITMENT OF LEADERSHIP BOTH AT NIH AND THE PRIVATE SECTOR TO ACHIEVING THE GOAL. AND CAN WE MOVE TO THE NEXT SLIDE, PLEASE. >> AND AS YOU CAN SEE, DEVELOP LINES ALONG THE RESEARCH AGENDA, IT'S MUTUALLY AGREEABLE BY NIH AND THE COMPANIES AND DEVELOPED UNDER THE OVERSIGHT OF A STEERING COMMITTEE. IN THE CASE OF RA LUPUS, THE STEERING COMMITTEE CHAIRED BY DR. CARTER AND DR. MARTY HODGE FROM PFIZER. THERE WERE 2--3 PROJECTS THAT WERE LAUNCH INDEED 2014 IN ALZHEIMER'S DISEASE AND A. D. AND IN TYPE 2 DIABETES. ABOUT TODAY IN R. A. LUPUS AND 2018 AND PARKINSON'S DISEASE PROJECT WAS LAUNCHED. NEXT SLIDE, PLEASE. NEXT SLIDE? IN THE NEXT SLIDE YOU WILL SEE THE LEVEL OF FUNDING THAT THE--THAT HAS BEEN COMMITTED TO THE ONGOING AMP PROJECTS. I SHOULD MENTION THE 2 NEWEST MEMBERS OF THE AMP GROUP OF PROJECTS ARE NOT LISTED HERE AND HAVE--ARE PROJECT AND IT IS GENE THERAPY IS IN SCHIZOPHRENIA. BUT THESE 4 PROJECTS THAT ARE LISTED HERE ARE FUNDED AND YOU CAN SEE THE LEVEL OF COMMITMENT. THERE IS A SIGNIFICANT DIFFERENCE BETWEEN THE INVESTMENT IN THE ALZHEIMERS DISEASE AMP PROJECT, AMP AD BECAUSE THAT PROJECT MOVED TO THE SECOND PHASE OF FUNDING, THE SECOND 5 YEARS OF FUNDING WHEREAS THE OTHER 3 PROJECTS HAVE NOT REACHED THAT POINT YET. BOTH THE AMP AND LUPUS AND THE AMP DIABETES WERE EXTEBDED INTO THE 6 YEAR WHICH IS WHERE WE ARE PRESENTLY. AS YOU CAN SEE THERE, THE NIH COMMITMENT TO THE AMP LUPUS HAS BEEN SIGNIFICANT AND WE HAVE BEEN EXTREMELY FORTUNATE TO PARTNER WITH THE NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES THAT PROVIDED A SIGNIFICANT, THE MOST--THE LARGEST SHARE, NIH SHARE OF THE FUNDING FOR AMP RA. THE GOOD NEWS IS THAT SOME OF THE PROJECTS ARE MOVING FORWARD INTO THE NEXT PHASE AND THAT THE COMPANIES HAVE AGREED AT LEAST FOR RA LUPUS TO CONTRIBUTE FUNDING FOR THE SIXTH YEAR WHICH I MENTION SIDE UNDERWAY. NEXT SLIDE, PLEASE. SO THIS IS WHO'S CARRYING OUT THE PROJECT AND THIS IS A SLIDE THAT YOU HAVE SEEN PREVENTIVEIOUSLY BECAUSE DR. JAIM MADE A PRESENTATION AT OUR FEBRUARY COUNCIL AND PROVIDED AN UPDATE ON THE SCIENTIFIC ADVANCES THAT HAVE BEEN MADE SO FAR BY THE NETWORK AND THE COMPONENTS, THERE ARE MANY INVESTIGATORS, MORE THAN 200 INVESTIGATORS ENGAGE IN AMP, LUPUS AND MULTILE INSTITUTIONS AND THAT CONTRIBUTES TO THE DIVERSITY OF THE PROJECT AND REALLY ENRICHES THE DISCUSSIONS IN THE OUTCOMES THAT REALLY HAVE BEEN INTEGRATED AND HAVE RESULTED IN THE VISION OF THE MANY INVESTIGATORS PROVIDING DIFFERENT PERSPECTIVES, CLINICAL, BASIC AND INFORMATICS PREDOMINANTLY. NEXT SLIDE, PLEASE. SO WHAT IS AMP RA LUPUS? WHAT IS THE PROJECT DOING? THE FOCUS IS ON DISEASE FUNCTION AND IN THE SECOND YEAR OF THE PROJECT THERE WAS AN AGREEMENT TO FOCUS THE SCIENTIFIC EFFORTS IN BOTH RA AND LUPUS ON THE INVESTIGATION AND DISEASE AND TISSUE AT THE SINGLE CELL LEVEL, WITH MAPPING AND IDENTIFYING THE SIGNIFICANT CELLULAR AND MOLECULAR COMPONENTS AND PATHWAYS THAT MEDIATE TISSUE INFLAMMATION, TISSUE INJURY AND TRY TO CORRELATE THOSE PATHWAYS WITH A CLINICAL DISEASE AND CLINICAL PHENOTYPE. THE HOPE IS THAT THE IDENTIFICATION OF THESE PATHWAYS WOULD LEAD TO THE IDENTIFICATION FOR TARGETS FOR DRUG INTERVENTION AND DRUG DEVELOPMENT AND [AUDIO CUTS OUT ] AND POTENTIALLY BIOMARKER. WE'RE VERY INTERESED IN INFRASTRUCTURE THAT WOULD ALLOW THE PROJECTS BASED ON RESEARCH ON TISSUE, BIOPSY, MATERIAL FROM PATIENTS WITH RHEUMATOID ARTHRITIS IS NOW FEASIBLE IN THE U.S., IT WASN'T THE CASE--IT WASN'T WIDELY DONE BEFORE AMP IN THE U.S. AND OBVIOUSLY MAKING SURE THAT KIDNEY BIOPSIES ARE CARRIED OUT FOR CLINICAL INDICATIONS COULD ALSO BE USED FOR RESEARCH. NEXT SLIDE. >> SO THIS IS WHERE WE ARE CURRENTLY WITH THE RAMP RA LUPUS PROJECT. WE ARE [AUDIO CUTS OUT ]--THE COLLECTION OF 100 BIOPSIES, RHEUMATOID ARTHRITIS BIOPSIES AND THEIR SEQUENCING, THE SINGLE CELL SEQUENCING IS NOW UNDERWAY, THERE WILL BE SINGLE CELL ANALYSIS OF BLOOD AND SIGNIFY TOMETRY ANALYSIS BOTH IN LUPUS AND RA. THE SEQUENCING OF THIS HAS NOW BEGUN OR THE PHASE 2 COMPONENT OF THE PROJECT THAT INCLUDES MORE THAN 160 KIDNEY BIOPSIES. WE EXPECT THE RESULTS TO BE AVAILABLE AND SHARED WITH THE COMMUNITY FOR RHEUMATOID ARTHRITIS BY THE END OF THIS CALENDAR YEAR AND FOR LUPUS AROUND FEBRUARY AND MARCH OF NEXT YEAR. NEXT SLIDE, PLEASE. SO I'M GOING--WE'RE GOING TO MOVE NEXT TO TALK TO YOU A LITTLE BIT ABOUT THE EVALUATION. NEXT SLIDE. THESE ARE THE INITIATIVES AS YOU CAN SEE HERE, THERE ARE MANY STAGES IN WHICH EVALUATION HAS BEEN CARRIED OUT AND AFTER COMPLETION, LESSONS LEARNED WHICH IS THE DENOTED HERE AND THE NUMBER 3 IS WHERE WE WILL BE TALKING ABOUT TODAY. BUT THERE WERE 2 OTHER--2 OTHER COMPONENTS IN THIS ASSESSMENT THAT WE HAVE MADE OF AMP RA LUPUS, 1 CONDUCTED BY FINEH, WHICH WAS A SURVEY OF THE COMPANIES AND MANY INVESTIGATORS INVOLVED IN RA, THAT HAD TO DO WITH IS THE PROJECT PRODUCING THE KIND OF INFORMATION, THE ACTUAL NUMBER OF INFORMATION THAT WE'RE LOOKING FOR WITH THE RESULTS OF THE PROJECT CAN INFORM YOUR DRUG DEVELOPMENT PROGRAMS IN MANY CASES AND THIS SURVEY WAS CONDUCTED FOR ALL THE PROJECT EXPSES IN THE CASE OF RA LUPUS, THERE WERE A NUMBER OF POSITIVE RESPONSES FROM REPRESENTATIVES FROM THE COMPANIES AND FROM ACADEMIC INSTITUTIONS INDICATING THAT THE INFORMATION SO FAR HAD BEEN HELPFUL IN TERMS OF INFORMING THE PRIORITIZATION OF THEIR TARGETS AND EVEN IF IN A COUPLE OF CASES THE DECISION TO,A BANDON CERTAIN DEVELOPMENT OF CERTAIN TARGETS THAT WERE NOT LOOKING PROMISING IN THE EARLY FACES OF THE AMP RA LUPUS PROJECT. TODAY WE WILL FOCUS ON--NEXT SLIDE--SO I SHOULD MENTION THIS A COMPOSITION OF OUR WORKING GROUP. THE WORKING GROUP HAS BEEN CO CHAIRED BY DR. JAMES AND I AM VERY GRATEFUL TO ALL OF THE MEMBERS WHO ARE NOW IN THE PROCESS OF EDITING THE LAST PORGT OF THE REPORT THAT INCLUDES SOME OF THE THOUGHTS THAT THE WORKING GROUP HAS ABOUT THE TEAM SCIENCE ASK THE WAY WE CONVEY TO THE SOWNES ILLEGALS IN FEBRUARY. NEXT SLIDE, PLEASE? >> SO THIS IS A COMPLAINT OF THE LESSONS EVALUATION THAT HAS NOT--IT HAS TO DO WITH QUANTITATIVE EVALUATION, PREVIOUSLY WE PRECEPTED TO YOU THE QUANTITATIVE EVALUATION IN WHICH WE ASSESS AND A NUMBER OF MUTATIONS AND COMMUNICATIONS AS WELL AS THE IMPACT FACTOR, WE TALKED A LITTLE BIT ABOUT OUTREACH AND DISSEMINATION EFFORTS AND THE SUCCESSFUL THOSE AND WE ALSO TALKED TO YOU ABOUT THE--SOME OF THE LEVEL OF COLABORATION--[AUDIO CUTS OUT ]--DR. SZTEIN, YOU MUTED YOURSELF. >> THANK YOU. SO THE QUALITATIVE COMPONENT IS ANALYSIS IS BASED ON FEEDBACK THAT WE OBTAINED IN RESPONSE TO A REQUEST FOR INFORMATION THAT WE PUBLISHED PLUS A SERIES OF INTERVIEWS THAT WE CONDUCTED WITH MEMBERS OF THE NETWORK REPRESENTATIVES FROM THE NOT FOR PROFIT ORGANIZATIONS AND REPRESENTATIVES FROM NIH. WE ALSO CONDUCTED DISCUSSIONS WITH EACH OF THE MEMBERS OF THE WORKING GROUP EARLY IN THE PROCESS AND LATE PROCESS TO INSURE THAT THEY ARE INDIVIDUAL CONCERNS ADDRESS BOTH IN THE PROCESS AND [INDISCERNIBLE]--WE HAD MANY, MANY GOALS AND AGAIN, I'M VERY THANKFUL ALL OF YOU PARTICIPATING IN THIS CAUSE. NEXT SLIDE, PLEASE. NEXT SLIDE. OKAY, SO, WE DID NOT CONDUCTED FORMAL SURVEY. [AUDIO CUTS OUT ] --INTERVIEWS, AND THEY ALL RELATED TO THE FRAMEWORK WE ESTABLISHED AND AGREED UPON FOR THE EVALUATION. NEXT SLIDE, PLEASE? SO THE INTERVIEWS WERE CONDUCTED MOSTLY IN PERSON AND THEY LASTED FOR ABOUT AN HOUR AND WE--INTERVIEW A NUMBER OF INVESTIGATORS BOTH SENIOR AND JUNIOR INVESTIGATORS AND NEW INVESTIGATORS INVOLVED WITH THE NETWORK, AS WELL AS REPRESENTATIVES FROM THE NOT FOR PROFITS AND INDUSTRY. NEXT SLIDE, PLEASE. SO AFTER INTERVIEWS WE COLLECTED ALL THE NOTES AND FROM THOSE INTERVIEWS, WE CODED THEM AND INDEPENDENT NONPERSON, NONRELATED TO EVALUATE OR NOT RELATED TO THE PROJECT CODED THEM ACCORDING TO THE DIFFERENT AREAS AS LISTED HERE FROM PROJECT, BALANCE, GOVERNANCE, DATA SHARING AND LISTED THEM AS POSITIVE FEEDBACK, CHALLENGES IDENTIFIED AND POSITIVE RECOMMENDATIONS AND AS YOU CAN SEE IN ORANGE, THE ORANGE BAR REPRESENTS POSITIVE FEEDBACK AND IN IMPACT SIGNIFICANCE IT'S REALLY NOTABLE THAT ALL THE--EVERYONE WHOM WE INTERVIEWED AGREED ON HOW THE IMPACT OF THE PROJECT HAS AGREED IT WAS EXPECTED AND IT WASN'T REALLY A SURPRISE FOR US BUT MANY OF THE CONCERNINGS AND THE CHALLENGES THAT WERE IDENTIFIED BY THE INTERVIEWEES HAD TO DO WITH BALANCE IN THE PROJECT AND STRUCTURE AND GOVERNONS ISSUES SO A LOT OF INTK GOOD FEEDBACK AND RECOMMEND ANTICIPATIONS AND HOW TO MAKE PROJECTS LIKE THIS THAT WE MAY DECIDE TO CARRY IN THE FUTURE, BETTER. NEXT SLIDE, PLEASE. SO, DURING THOSE INTERVIEWS AND AFTER ANALYZING INFORMATION THAT WE RECEIVED, THERE WERE MANY THINGS THAT EMERGED THAT SEEMED TO FIND NOT IN COMPLETE UNIFORM CONSENSUS BUT REALLY SIGNIFICANT AGREEMENT AMONG THE INTERVIEWEES. OF AS I MENTIONED BEFORE, I THINK IT'S IMPORTANT AS WE THINK FOR FUTURE PROJECTS, THERE WAS SOME SUCCESS ABOUT THE IMPACT OF THE STUDY AND MOST JUNIOR-SENIOR INVESTIGATORS WERE EXCITED ABOUT PARTICIPATING IN THE PROJECT AND BEING PART OF THE PROJECT DESPITE ALL THE YOU KNOW DESPITE OF THE DIFFICULTIES THAT THE TEAM FACED. AND THERE WERE SOME DIFFICULTIES WITH THE PROJECT, THE FACT THAT THEY WERE DEALING WITH 2 DISEASES OPPOSE TO 1, WAS AN ISSUE THAT WAS IDENTIFIED BY MANY INTERVIEWYEES IN THE CHALLENGE. BUT THE IMPACT OF THE TISSUE AND ACQUISITION OF THE TECHNOLOGIES FOR DISCOVERY WERE RANKED AMONG THE MOST IMPORTANT FACTORS THAT KEPT PEOPLE ENGAGED WITH THE PROJECT. ONE OF THE ISSUES WE IDENTIFY THAD WE THOUGHT THIS WAS A VERY SIGNIFICANT--SIGNIFICANT INFORMATION THAT THE WE MAY FIND ACTIONABLE IS THE RECOMMENDATION IN ANY FUTURE PROJECTS, NIH PROVIDES AN OPPORTUNITY FOR THE RESPONSIBILITIES OF AN INVESTIGATORS AND DIFFERENT TASKS WITHIN THE PROJECTS TO BE CLEARLY ESTABLISHED FROM THE BECAUSE THE LACK OF [INDISCERNIBLE] CONFUSION [AUDIO CUTS OUT ] NEXT SLIDE, PLEASE. NEXTION, SORRY. SO ANOTHER IMPORTANT THEME THAT EMERGED WAS THAT THE NIH, PERHAPS IN ITS ROLE WAS NOT ONLY THE ENTITY THAT IS MANAGING THE AWARDS IN THE SCIENCE BUT ALSO THE ENTITY THAT COMMUNICATES EXPECTATIONS AND THE EXPECTATIONS NEED TO BE COMMUNICATED CLEARLY AND OFTEN. ONE OF THE MOST INTERESTING AND ACTUALLY GRATIFYING RESPONSES THAT WE GOT WAS FROM JUNIOR INVESTIGATORS, BOTH POST DOCS AND PREDOCS WHO ARE PARTICIPATING IN THE PROJECT WHICH WERE VERY ENTHUSIASTIC ABOUT BEING MEMBERS OF THE PROJECT, EVEN IF THEY DID NOT FULLY UNDERSTAND THE SCOPE OF THE--[AUDIO CUTS OUT ]--EXCITED TO BE PARARE TIS PARTICIPATE IN A TRIALING AND HAVE FOUND WAYS OF ESTABLISHING NEW COLLABORATIONS THAT WERE MEANINGFUL FOR THE [INDISCERNIBLE], IT WAS VERY, VERY REWARDING. WE ALSO GOT SIGNIFICANT NUMBER OF PARTICIPANTS RECOMMENDED THAT WE CONSIDER THE CREATION OF OPPORTUNITIES FOR PROFESSIONAL DEVELOPMENT WITHIN THE TEAM SCIENCE PROJECT. CERTAINLY AN ENVIRONMENT FOR THIS HAS AN OPPORTUNITY, CREATES AN OPPORTUNITY FOR TRAINING OF BOTH SENIOR AND JUNIOR INVESTIGATORS ON NOT ONLY IN NEW TECHNOLOGIES BUT ALSO ON APPROACHES TO DEVELOP EFFECTIVE COLLABORATIONS. SO IF WE CAN MOVE TO THE NEXT SLIDE. THE WORKING GROUP IS NOW EDITING THE FINAL PORTION OF THE REPORT WHICH WILL INCLUDE THE OBSERVATIONS THAT ARE GOING TO BE BROUGHT FORWARD TO THE COUNCIL. AS AN INSTITUTE LOOKS ABOUT THE FUTURE AND CAN SEE THERE'S FUNDING OF TEAM SCIENCE, WHAT OTHER FACT OARS THAT NEED TO BE TAKEN INTO OUR ACCOUNT. SO THE REPORT IS GOING TO BE FOCUSED ON--FOCUSING ON VALUE, AS 1 OF THE DRIVER'S THAT MOTIVATES AND ENGAGES THE SCIENTIFIC COMMUNITY TO COLLABORATE AND PARTICIPATE IN THIS HIGHLY COMPLEX PROJECTS: THE REPORT IS ALSO GOING TO INCLUDE CONSIDERATIONS OF ABOUT TEAM SCIENCE AND COMPETITION WHICH WAS AND COMPOSITION WHICH WAS 1 OF THE QUESTIONS THAT DR. [INDISCERNIBLE] BROUGHT TO THE TABLE WHEN HE GAVE THE CHARGE TO THE WORKING GROUP. AS YOU ARE AWARE, THERE IS PLENTY OF--THERE IS A LOT OF INFORMATION OUT THERE ABOUT THE EFFECTIVENESS OF LARGE AND SMALL TEAMS SO THIS IS A VERY IMPORTANT QUESTION. TEAM PROCESSES WILL BE ADDRESSED AND SOME CONSIDERATIONS THERE ABOUT APPROACHES TO COMMUNICATION. NEXT SLIDE. ONE OF THE MOST INTERESTING ITEMS WE DISCUSSED WITH THE WORKING GROUP ARE THE OPPORTUNITIES FOR TRAINING AND HOW COULD THAT BE--HOW COULD THOSE BE LEVERAGED BY OTHER ORGANIZATIONS WHO ARE PARTICIPATING AND MAY BE PARTNERING WITH THE NIH AND HARNESSING THE OPPORTUNITY FOR JUNIOR INVESTIGATORS AND THIS REPORT WAS ADDRESSED RESOURCES IN TERMS OF BUDGET AND THE 1 FINAL ITEM, THE--THE REPORT IS GOING TO INCLUDE REFERENCE TO SOME NAMES TO PROVIDE FOR ENGAGEMENT OF SITES WHO ARE INTERESTED IN PARTICIPATE NOTHING TEAM SCIENCE THROUGH AND THE OPPORTUNITIES FOR INVESTIGATORS WHO ARE NOT PART OF THE TEAM TO JOIN THE TEAM AFTER THE PROJECT IS INITIATED THROUGH THE USE OF OPPORTUNITY FUNDS. NEXT. THESE ARE MY ACKNOWLEDGES TO THE WORKING GROUP MEMBERS AND THE NIAMS TEAM, AND WORKING LESSONS LEARNED IN DR. NANDINI, AND OTHERS, THE PARTNERS AND THE INVESTIGATORS AND THE FENIH WHICH IS MANAGING THE PARTNERSHIP. THE LAST 2 SLIDES IF YOU CAN MOVE FORWARD, I WILL BE VERY BRIEF IS JUST TO MENTION THAT IF NIEH, FNIH IS NOW STARTED THE PROCESS TO MOVE FORWARD WITH THE NEXT PHASE FOR THE AMP RA/LUPUS HAS RECEIVED A NEW NAME. IT'S GOING TO BE THE NEW NAME IS AMP AIM FOR AUTOIMMUNE AND MEDIATED DISEASES. FNIH ESTABLISHED A WORKING GROUP THAT DEVELOPED A SERIES OF CONCEPTS AND THE CONCEPT TO MOVE FORWARD AS BEEN PRESENTED TO THIS EXECUTIVE COMMITTEE CHAIRED BY DR. COLLINS, THE CONCEPT HAS BEEN APPROVED. FNIH HAS BEGAN THE PROCESS OF CANVASSING COMPANIES THAT MIGHT BE INTERESTED IN PARTICPATING IN THE FUTURE AMP AIM PROJECT. I WILL STOP HERE AND I'LL BE HAPPY TO ANSWER ANY QUESTIONS BUT BEFORE WE DO THAT, MAYBE EITHER DR. [INDISCERNIBLE] OR DR. JAMES WOULD LIKE TO MAKE ANY COMMENTS? >> SO I WOULD JUST LIKE TO TAKE THIS OPPORTUNITY TO THANK DR. SUSSANA SERRATE-SZTEIN, SHE'S DONE A FANTASTIC JOB OF CORRALLING THIS GROUP AND GATHERING ALL KINDS OF INFORMATION. WE RECEIVED DOCUMENTS ABOUT TEAM SCIENCE AND THE SCIENCE OF TEAM SCIENCE AND HAD INVITED SPEAKERS FROM THAT AREA AS WELL AS BRINGING IN WAYS TO LOOK AT VISUALIZATION FOR SOME OF THE QUANTITATIVE DATA. WE TALKED ABOUT SOME OF THE QUANTITATIVE DATA. IN FEBRUARY YOU WILL HEAR ABOUT THE ENTIRE REPORT. I BEING THAT 1 OF THE THINGS THAT WAS BROUGHT UP BY COUNCIL BEFORE THAT HAS BEEN PUT INTO THE REPORT DRAFT THAT WE'RE WORKING ON IS ABOUT WAYS THAT WE CAN ENGAGE INVESTIGATORS FROM OUTSIDE OF AMP TO BE ABLE TO UTILIZE THE RESOURCE AND TO BUILD THE RESOURCE SO THAT WE CAN ANSWER EVEN BIGGER QUESTIONS. AND SO, THINGS ABOUT LIKE USING OPPORTUNITY FUND OR HAVING SOME KIND OF SMALL GRANT MECHANISM THAT MAY BE EITHER BY 1 OF THE PARTNERS OR FROM NIH TO BE ABLE TO APPLY NEW ANALYTIC APPROACHES OR BE ABLE TO REANALYZE DATA IN NEW WAYS FROM THESE TYPES OF LARGE COLLABORATIVE GRANTA APPLICATIONS. SO I WANT TO GIVE OTHER PEOPLE TIME TO TALK. SO, JILL? >> YEAH, SO I WOULD ECHO EVERYTHING JUDITH SAID INCLUDING THE ACCOLADE TOTION SUZANNEA BUT WHAT ALSO MAKES SUZANNEA'S POSITION VERY IMPORTANT HERE IS THAT SHE REALLY ATTENDED PRETTY MUCH EVERY SINGLE MEETING OF THE WORKING GROUPS AND THERE WAS A HUGE COMPLEXITY TO AMP AND WILL CONTINUE IN THE FUTURE. HOW DO WE ORGANIZE THE TECHNICAL PEOPLE, THE CLINICAL PEOPLE? THIS IS A VERY IMPORTANT PARTNERSHIP AND I THINK AMP REALLY WENT VERY FAR TO INTEGRATE THAT AND WE CONTINUE TO DO THAT AND TO BRING IN JUNIOR INVESTIGATORS USING AMP AS A PLATFORM TO DO THAT IS ALSO PRETTY UNIQUE WHERE THE PIs REALLY TURNED AROUND AND SAID, HEY HOW CAN OUR JUNIOR INVESTIGATORS PARTICIPATE? AND I THINK YOU WILL FIND THAT WHETHER IT'S A PERSON ON A T32 OR A PERSON WITH A K-AWARD, WE REALLY DID A SPECTACULAR JOB, I THINK AT LEAST IN THE LUPUS GROUP AND I'M SURE THE RA WHICH I KNOW A LITTLE LESS TO BRING IN A LOT OF THE JUNIOR INVESTIGATORS WHO LED SOME OF THE PROJECTS. I THINK THAT'S BEEN A HUGE PLUS. >> NEXT SPEAKERS ARE ONLINE, SO GIVE JOAN A CHANCE TO HAVE THE FINAL QUESTION, BUT I DO WANT TO FIND A WAY TO GET OTHER COUNCIL MEMBERS TO PROVIDE FEEDBACK, SO MAYBE WHAT WE'LL DO IS DISTRIBUTE SUZANNEA'S SLIDES AND ASK YOU ALL TO GIVE FEEDBACK, PARTICULARLY ON THIS SORT OF BACK END SLIDES ABOUT TOPICS AND LESSONS LEARNED AND HOW TO BUILD THESE TYPES OF PROJECTS IN THE FUTURE. SO, JOAN, LAST QUESTION? >> WE ARE NOT HEARING JOAN. >> HI, JOAN, YOU ARE UNMUTED. CAN YOU HEAR US? QUEE SEE THAT YOU HAVE YOUR HAND--WE SEE THAT YOU HAVE YOUR HAND RAISED. WELL WE CERTAINLY WANT TO KNOW WHAT SHE HAS TO SAY, BUT I'M AFRAID WE BETTER MOVE ON AND JUST BECAUSE OF PLIGHTNESS TO OUR SPEAKERS. SO WE WILL MOVE ON NOW TO THE PRESENTATION KATZ AWARD THIS IS A TRANSNIH EFFORT TO SUPPORT-- >> SORRY. , WHAT? >> THIS IS NEIL SORRY I WAS TOLD THAT SHOSHANA WANTED TO BE THE PERSON TO PRESENT DO YOU STILL WANT TO BE THAT PERSON OR SHOO WE CONTINUE TO HAVE MARK BROWN PRESENT FOR YOU? IS THAT THE WRONG AWARD? AM I COMPLETELY OFF RIGHT NOW? >> IS THAT NEIL IT'S DAVID GEORGE. HI. >> YEAH, WE ARE GOING TO CO-PRESENT, I'M NOT SURE WHAT YOU MEAN BY--THE SLIDES WE ARE HAPPY TO HAVE YOU DO IT. >> OKAY. , THAT WOULD BE FINE, THANK YOU. >> OKAY. LAWYER, SO I JUST -- >> ALL RIGHT, SO THIS IS A TRANSNIH EFFORT AND THIS IS SIGNIFICANT TO THOSE OF US WHO WORK ON THIS, AND THAT'S WHY WE ASKED DR. GEORGE AND DR. KAHANA TO PRESENT THE OPPORTUNITY. AND DR. NELSON WORKED ON THAT BUT GREAT THANKS TO DAVID AND SHOSHANA FOR THEIR LEADERSHIP OF THE WORKING GROUP. AND WITH THAT WE WILL TURN IT OVER TO YOU. >> THANK YOU, THANK YOU FOR THE INTRODUCTION DR. CARTER AND GOOD AFTERNOON EVERYONE AND ON BEHALF OF THE COLLEAGUES ON THE WORKING GROUP FOR THIS NEW PROGRAM, SHOSHANA WANT TO THANK OUR COLLEAGUES AND COUNCIL AT THE NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES FOR THIS NEW PROGRAM AT NIH, THE STEPHEN I. KATZ INVESTIGATOR RO1 AWARD PROGRAM. NEXT SLIDE, PLEASE. SO--SO MY WIFE HAS A POSITION THERE AND SHOSHANA LISTS NO DISCLOSURE. SO NEXT SLIDE PLEASE. AS YOU'RE WELL,A WARE THIS PROGRAM WAS NAMED TO HONOR DR. KATZ DIRECTOR AND HIS HIS NEXT GENERATION OF SCIENTISTS AND EARLY CAREER SCIENTISTS IN TRAINING AND MORE THAN THAT HE WAS THE MENTOR TO MANY AROUND HIM, BOTH YOUNG AND NOT SO YOUNG. SHOSHANA RECENTLY HAD A MEETING TO UPDATE DR. MIKE LAUER AT THE INTRAMURAL RESEARCH AND HIS DEPUTY ON THE STATUS AND UPDATE TO THE PROGRAM AND OF COURSE HE TALKED ABOUT DR. KATZ, AND HOW HE FELT HE WAS A MENTOR TO HIM AND MIKE POINTED OUT THAT PROBABLY HUNDREDS OF PEOPLE ACROSS NIH WOULD THINK THE SAME IN THEIR ROLE WITH DR. KATZ. AND FROM MY INSTITUTE, INSTITUTE OF BIOMEDICAL ENGINEERINGA THE SEARCH COMMITTEES THAT HIRED THE 2 IC DIRECTORS IN NIBIB'S HISTORY, THE FOUNDING DIRECTOR DR. ROBERT PETTIGREW, MAYBE EVEN THE CO CHAIR OF THE CURRENT 1, I DON'T KNOW WHETHER HE WAS ORIGE NAWILLLY AFTER DR. STROMBERG, SO A BRIEF HISTORY OF HIM AS WELL AT MY INSTITUTE. NEXT SLIDE, PLEASE. SO IN TERMS OF WHERE THE CONCEPT FOR THIS AWARD CAME FROM IN 2017, THE ADVISORY COMMITTEE TO THE NIH DIRECTOR WORKING GROUP, NEXT GENERATION RESEARCH INITIATIVE, ASSEMBLED AND WAS CHARGED BY NIH DIRECTOR DR. FRANCIS COLLINS TO PROVIDE ADVICE AND RECOMMENDATIONS IN SEVERAL AREAS 1 OF WHICH WAS ON APPROACHES FOR DEVELOPING OR ENHANCING NIH FUNDING MECHANISMS AIMED AT ESIs AND AFTER A NUMBER OF MEETINGS AND LOTS OF HARD WORK IN DECEMBER OF 2018, A BROAD REPORT WAS ISSUED BY THE NGRI, I HAVE TO CONCENTRATE TO SAY THAT AND MAKE SURE NOT TO SAY ANOTHER INSTITUTE WITH A SIMILAR ACRONYM AT NIH. SO 2 OF THEM THAT ARE GERMANE TO THIS EFFORT, BECAUSE OF DR. COLLYNN'S ADOPTION OF THISEM LED TO THE DEVELOPMENT OF THIS PROGRAM, THE ESI RO1 PROGRAM, THE FIRST OF THOSE 2 RECOMMENDATIONS THAT WERE ADOPTED IS TO EXPAND PATHWAYS FOR FUNDING ESIs THROUGH PROGRAMS THAT DO NOT REQUIRE PRELIMINARY DATA. SO THE NGRI REPORT, WORK GROUP REPORT PROPOSED THAT THE ESIs BE SUPPORTED AND THEY POINTED OUT SORT OF 2 PATHWAYS, NOT THAT THESE ARE THE ONLY 1 YOU 1S BUT THEY WERE IN THE REPORT THAT ESI COULD BEGIN THEIR RESEARCH CAREER PATH IN THE DIRECTION THAT SORT OF CAME OUT OF THEIR POST DOCTORAL WORK, MOSTLY WITH CONTINUOUS WITH THAT AND FOR WHICH THEY HAVE PRELIMINARY DATA BUT ALSO THEY WANTED TO HAVE THE ABILITY FOR AN ESI TO LAUNCH A CAREER WITH THE PROPOSAL THAT PROPOSES WORK IN A NEW DIRECTION THAT BUILDS GENERALLY UPON THEIR PAST TRAINING EXPERIENCE BUT IS UNRELATED TO THEIR POST DOCTORAL WORK. AND THEN THE SECOND ITEM RELEVANT TO THIS PROGRAM IS THAT THE ESIs HAVE AN OPPORTUNITY TO COMPETE FOR RO-1 EQUIVALENT APPLICATIONS WITH THESE CHARACTERISTICS FOR THE NEXT 5 YEARS AND AGAIN THE NGRI WORK GROUP IS INTERESTED IN HAVING A SUSTAINED INITIAL FUNDING FOR THE ESI. SO NEXT SLIDE, PLEASE. SO IN ADOPTING THESE RECOMMENDATIONS FROM THE NGRI, DR. COLLINS THEREBY PROPOSED THESE KEY CHARACTERISTICS FOR THE KATZ ESI RO1 AWARD AND HE ANNOUNCED THEM AT THE JUNE 29th MEETING OF THE ACD. IF YOU'RE INTERESTED, I THINK IT'S AROUND THE 45 MINUTE MARK OF THE VIDEOCAST. WE ACTUALLY PLAYED IT AT 1 OF OUR COMMITTEE MEETINGS. SO DR. COLLINS POINTED OUT AT THAT TIME THAT A PROGRAM WILL BE DWENNED THAT WILL HAVE THE CHARACTERISTICS OF BEING A SEPARATE COMPETITIVE INVESTIGATOR-INITIATED RO1 TO WHICH EARLY INVESTIGATORS COULD SUBMIT APPLICATIONS WITH LITTLE OR NO PRELIMINARY DATA. YOU WILL SEE THE SOON THE RECOMMENDATION CAME, WE WENT WITH THE NO PRELIMINARY DAT AND THAT AN APPLICANT DOES NOT FEEL OBLIGATED TO USE THEIR PRELIMINARY DATA FROM THEIR TRAINING BUT COULD GO IN A TOTALLY NEW DIRECTION THAT THEY WERE EXCITED ABOUT MPLET SO VERY CONSISTENT WITH PROPOSED BY THE NGRI WORK GROUP. SO HAVING MADE THESE RECOMMENDATIONS, THEN A TRANSNIH COMMITTEE WAS ESTABLISHED WITH--I WON'T GO THROUGH THEM ALL EXCEPTION FOR 1, WITH THIS ESTABLISHED A COMMITTEE WAS CREATED WITH THE DIVERSITY OF INSTITUTES AND CENTERS AND O. D. OFFICES WE HAVE MEMBERS WITH BACKGROUNDS FROM PROGRAM INCLUDING THE COMMON FUND, REVIEW, TRAINING AND WORKFORCE DEVELOPMENT, REFERRAL POLICY, LEADERS OF DIVISIONS OF EXTRAMURAL ACTIVITIES AND CO CHAIRED BY A MEMBER OF [INDISCERNIBLE] [AUDIO CUTS OUT ]--AND AS DR. CARTER MENTIONED WE ALSO WOULD LIKE TO MAKE A BIG SHOUT OUT TO NIAMS, DR. NELSON WHO SERVED ON THE COMMITTEE AND IT WASENTIOUS SPECIALLY WONDERFUL TO HAVE MELINDA ON THE COMMITTEE BECAUSE SHE WORKED CLOSELY WITH DR. KATZ FOR A LONG TIME AND SHE OFTEN PROVIDED MOTIVATION TO THE COMMITTEE. SHE SHARED STORIES AND HELPED US TO KNOW WHAT IT'S LIKE WORKING WITH DR. KATZ FOR THOSE OF US WHO DID NOT HAVE THE PLEASURE OF WORKING WITH HIM CLOSELY: SO THANK YOU MELINDA, WE APPRECIATE YOUR CONTRIBUTIONS TO THE COMMITTEE. WE'RE NOT DONE YET. YOU'RE NOT OFF THE HOOK YET. SO IN TERMS OF MAPPING OUT GIVING THIS CHARGE, EXCUSE ME, THERE IS A MILIEU OF OTHER PROGRAMS AT NIH THAT HAVE SOME COMBINATION OF VARIATIONS ON THESE FEATURES SO WE GRAPHICALLY PUT THEM HERE. OUR CORE CHARGE TO HAVE SUPPORT FOR AN ESI THAT HASN'T GENERATED PRELIMINARY DATA YET BECAUSE THEY LIKE TO GO IN A NEW DIRECTION FOR A PERIOD OF 5 YEARS, THERE ARE OTHER INITIATIVES AROUND NIH THAT HAVE THESE CHARACTERISTICS WE THINK NONE OF THEM HAVE THIS PREICIZE GROUPING OF CHARACTERISTICS SO THE DP 2 IS WELL KNOWN, IT'S VERY HIGH RISK, IT'S A PERSON-BASED GRANT AS OPPOSE TO A PROJECT BASED GRANT, A MODEST NUMBER OF THEM OR COMPARATIVELY MODEST NUMBER OF THOSE AWARDS ARE MADE, DIRECTORS EARLY INDEPENDENCE AWARD, THE DP 5 FOR THIS ON A VERY, VERY JUNIOR, I THINK IF I RECALL CORRECTLY THE GOAL OF HAVING SKIPPED THE POST DOC AND THEN THERE ARE OTHER PROGRAMS NIGMS HAS THE 1 IN GREEN, NIEHS HAS THE 1S IN PRURPLE AND NIH HAS GRAY, I THINK THEY'RE SIMILAR, I THINK 1 OF THEM WAS MODELED ON THE OTHER, FOR NO OR PRELIMINARY DATA INFORMATION, NIBIB HAS A TRAIL BLAZER PROGRAM, R21 DIFFERENT MECHANISM AND NIGMS HAS A NO PRELIMINARY DATA MECHANISM, NIBIB HAS R21 WITH NO PRELIMINARY DATA SO THERE'S DIFFERENT CHARACTERISTICS AND DIFFERENT MECHANISMS BUT WE THINK THE KATZ OFFERS A UNIQUE SET THAT THE OTHERS DON'T HAVE. NEXT SLIDE, PLEASE. SO 1 THING, DON'T BE WORRIED ABOUT ANYTHING GO AWAY ON ACCOUNT OF THE KATZ COMING INTO EXISTENCE. AN ADDITIONAL PATHWAY, PREVIOUSLY UNAVAILABLE FOR ESIs, THERE'S NO FUNDING OPPORTUNITY GOING AWAY AS A RESULT OF THIS PROGRAM. THERE WILL BE PLENTY OF OPPORTUNITIES, THEY WILL CONTINUE TO EXIST FOR ESIs TO APLOY TO PRELIMINARY DATA, WHERE THEY WISH TO CONTINUE THEIR WORK CONSISTENT WITH THEIR CURRENT RESEARCH, THIS PROGRAM MAY NOT BE FOR ALL ESIs, IT'S AN OPPORTUNITY, SO IT'S JUST AN ADDITIONAL CHANCE IF AN ESI WISHES TO GO IN A NEW DIRECTION, LACKING COMMUNITY DATA, THIS IS AN OPPORTUNITY FOR THEM. NEXT SLIDE, PLEASE. OKAY, SO HAVING ESTABLISHED A KEY FEATURES OF THE PROGRAM IS ESPOUSED BY LEADERSHIPS AND CARRIED FORTH BY THE COMMITTEE. SHOSHANA WILL TAKE OVER AT THIS POINT OF THE PRESENTATION AND EXPLAIN MORE ABOUT THE KEY FEAT IRBS, APPLICATION REVIEW AND TIMELINE AND INFORMATION CLAIM PLANNING. , WONDERFUL, THANK YOU SO MUCH AGAIN, SO TO EMPHASIZE AGAIN THE KEY FEATURES OF THE KATZ PROGRAM WILL INCLUDE-- >> EXCUSE ME, SHOSHANA COULD YOU SPEAK UP MERE WE'RE HAVING TROUBLE HEARING YOU. >> SURE IS THIS BETTER? >> THAT IS A LITTLE BETTER. >> OKAY. SO TO EMPHASIZE AGAIN THE KEY FEATURES OF THE PROGRAM ARE THAT IT WILL BE OPEN FOR ESIs, THE PROJECT HAS TO REPRESENT A SIGNIFICANT RESEARCH PROJECT, NO PRELIMINARY DATA FOR THE PROJECT ARE ALLOWED AND THE PROPOSAL MUST REPRESENT A CHANGE IN DIRECTION, A CHANGE IN RESEARCH DIRECTION FOR THE PI. NEXT SLIDE, PLEASE. SO A LOT OF QUESTIONS THAT WE'VE RECEIVED ARE WHAT DOES PRELIMINARY DATA MEAN EXACTLY? SO ESSENTIALLY WE ARE STATING THAT [AUDIO CUTS OUT ] PUBLISHED DATA IS NOT ALLOWABLE AND IT'S INCLUSION WILL RESULT IN AN APPLICATION BEING W DRAWN. WE DO ACTUALLY PROVIDE ADDITIONAL DEFINITIONS FOR PRELIMINARY DATA IN THE FOA ITSELF. NEXT SLIDE, PLEASE? SO AGAIN IMPORTANTLY THE NEW RESEARCH DIRECTION IS RELATIVE AND MUST BE DIFFERENT FROM THE PIs PREVIOUS RESEARCH EFFORT. IT SHOULD NOT BE AN OBVIOUS OR INCREMENTAL EXPANSION OF PRIOR WORK. IT COULD BE A NEW APPROACH, METHODOLOGY, TECHNIQUE, DISCIPLINE, TARGET OR PARADIGM. IMPORTANTLY, THE OWENESS IS ON THE APPLICANT TO REALLY EXPLAIN HOW THE PROPOSED RESEARCH DIRECTION IS NOW TOO HIM OR HER AND AGAIN, A NEW RESEARCH DIRECTION IS VERY DISCIPLINE SPECIFIC AND REALLY DEPENDENT ON THE FIELD OF SCIENTIFIC RESEARCH. NEXT SLIDE, PLEASE. SO THESE APPLICATIONS WILL BE REVIEWED IN CSR. CSR HAS EXPERIENCE AND EXPERTISE IN REVIEWING APPLICATIONS WITHOUT PRELIMINARY DATA. DAVID AND I WILL BE WORKING WITH CSR TO PREPARE ORIENTATION MATERIALS ABOUT THE PROGRAM FOR BOTH SROs AND REVIEWERS. NEXT SLIDE, PLEASE. SO IN TERMS OF TIMELINE, WE EXPECT THERE WILL BE 3 RECEIPT DATES THROUGHOUT THE YEAR. THE FOA WILL BE RELEASED SHORTLY. THE FIRST RECEIPT DATE WILL BE WINTER 2021, PEER REVIEW AND COUNCIL IS SUMMER 2021, AND WE EXPECT AWARDS TO BE MADE EARLY IN FY2022. NEXT SLIDE, PLEASE. IN TERMS OF COMMUNICATION, WE ARE WORKING ON A--I WOULD SAY A VERY AGGRESSIVE COMMUNICATION PLAN WE'VE ALREADY HAVE BETA VERSION OF A KATZ WEBSITE UP THAT WE'RE CONTINUING TO ADD INFORMATION TO. WE'VE GENERATED BOTH FAQs FOR THE EXTRAMURAL AND THE INTRAMURAL COMMUNITIES, MIKE LAUER HAS ALSO EXPRESSED INTEREST IN BLOGGING ABOUT THE PROGRAM ONCE IT'S LIVE. WE ARE HAPPY ALSO TO TALK ABOUT THIS AT VARIOUS IC COUNCILS, WE WILL BE WORKING WITH THE COMMUNICATION OFFICES AT VARIOUS NIH ICs AND DAVID AND I WILL ALSO BE WORKING WITH OUR COMMUNICATION ICs TO WORK ON DROP-IN SLIDES FOR NIH STAFF WHO WE EXPECT WILL BE GETTING A LOT OF QUESTIONS FROM POTENTIAL APPLICATIONS. WITH THAT, DAVID AND I ARE HAPPY TO ANSWER. >> THIS IS VERY CLEAR, WE BREESHT YOU TAKING THE TIME TODAY AND LOOKING TO SEE ANY HANDS RAISED? >> SO SHOSHANA, I HAVE A QUICK QUESTION, YOU MAY HAVE ALREADY SAID THIS, AND I'M SURE THIS WILL COME UP IN TERMS OF THE ELIGIBILITY BUT SO DOES THE ESI HAVE TO BE SOMEBODY WHO ALREADY HAS A GRANT OR WAS FUNDED BY NIAMS OR IS THIS A NEW ESI, THE APPLICANT? >> SO IF I'M UNDERSTANDING YOUR QUESTION CORRECTLY, ANYONE WHO IS IN ESI, IN OTHER WORDS ANYONE WHO IS WITHIN THEIR 10-YEAR PERIOD RIGHT OF RECEIPT OF THEIR DEGREE AND HAS NOT HELD A SUBSTANTIAL RESEARCH AWARD IS ELIGIBLE TO APPLY FOR THIS. >> OH, OKAY. >> GOOD POINT. JUDITH. >> SORRY JENNIFER. SO IS THIS GOING TO BE HOUSED--SO WILL THESE AWARDS COME FROM ANY INSTITUTE THAT IS AT THE AREA OF INTEREST OR IS THIS AN OFFICE OF DIRECTOR AWARD? >> THIS IS BEING--THE SHORT ANSWER IS IT'S BEING ISSUED BY THE O. D. BUT WE EXPECT THE VAST MAJORITY OF NIH ICs TO SIGN ON. >> SO JUDITH DO YOU THINK YOU RECOMMEND THAT WE NOT SIGN ON TO THE KATZ AWARD. >> I WAS HOPING WOULD BE KRA MONEY FROM THE OFFICE OF THE DIRECTOR. -IS. >> S ARE IS THERE GOING TO BE A SEPARATE PANEL THAT REVIEWS ALL OF THESE. -- >> REGULAR STUDY SECTIONS TO MATCH THE WORK PROPOSED THE BEST WITH WHAT SHE'S SAYING CSI SROs WILL BE TEAMING UP WITH US TO MAKE SURE THEY KNOW THE VISION OF THE PROGRAM THAT THE REVIEWERS ARE WELL TRAINED, SO THE WHYED THAT THERE'S SO MANY INSTITUTES INVOLVED THAT PRESUMABLY WE DON'T KNOW YET, BUT IF THERE'S A HEALTHY RESPONSE, WE WILL TRY TO PUT THEM IN THEIR APPROPRIATE SCIENTIFIC HOMES BUT ABSOLUTELY ATTENTION TO REVIEW WILL BE VERY IMPORTANT TO THIS SUCCESS OF THE PROGRAM. >> OKAY AND--DO WE KNOW HOW MANY WILL BE FUNDED IN A PARTICULAR YEAR? >> I'M SORRY PARDON ME. >> HOW MUCH MONEY IS AVAILABLE OR HOW MANYY WILL BE FUNDED IN THE YEAR. >> THAT'S AN INSTITUTE QUESTION. AND TBD, BUT BUT IN KEEPING WITH THEIR COMMITMENT TO ESIs, I THINK THIS WILL BE AN IMPORTANT TOOL BUT I'M NOT GOING TO ANSWER THE QUESTION ANYMORE SPECIFICALLY THAN THAT. >> OKAY, 1 MORE QUESTION, I DIDN'T HEAR YOU TALKING ABOUT AS YOU CONSIDER THE CRITERIA, IN REGARDS TO OUR EARLIER CONVERSATION ON RACISM AND STRUCTURAL ISSUES, SO IF WE TAKE AWAY PRELIMINARY DATA WHAT'S LEFT IS THE IDEA AND THE PERSON, RIGHT? AND ARE THERE--AND THEIR PAST ACCOMPLISHMENTS, THOSE WILL BE THE MAJOR THINGS I THINK THAT STUDY SECTIONINGS WILL LOOKA AT. SO WILL THERE BE BIAS IN JUST HAVING THOSE CRITERIA AVAILABLE? OR IS THERE A PLAN TO HAVE CRITERIA RELATED TO PROMOTING DIVERSITY SX HEAT INCLUSION OR HEALTH DISPARITIES IN ADDRESSING THESE TYPES OF ISSUES. I THINK DR. KATZ IS VERY PASSIONATE ABOUT THAT. >> I THINK THAT'S A GREAT IDEA, WE ARE PRETTY FAR ALONG IN THIS VERSION OF THE FOA WHEN WE ACTUALLY RECEIVED THE FEEDBACK THAT WE REALLY MIGHT WANT TO CONSIDER POTENTIALLY A DIVERSITY FOCUSED OR JUST TO BE A LITTLE BIT MORE MINDFUL ABOUT INCLUSION OF DIVERSITY FACTORS, SO I DON'T KNOW IF IT WILL HAPPEN IN THIS VERSION, BUT I CERTAINLY THINK THAT--IT'S IMPORTANT POINT OF INCLUSION. >> YEAH, ULTIMATELY THAT DECISION WILL BE AT THE INSTITUTE LEVEL AND AGAIN AS I SAID EARLIER, IT IS ABSOLUTELY APPROPRIATE FOR US TO INSURE THAT THERE'S DIVERSITY OF PERSPECTIVES IN THE EARLY STAGE INVESTIGATORS. SO THAT IT WOULD BE A POTENTIAL TOOL TO HELP INSURE THAT THERE'S A PIPELINE OF DIVERSITY OF PERSPECTIVES. I THINK WE BETTER MOVE ON. WE HAVE 1 MORE PIECE OF BUSINESS. SO THANK YOU DAVID AND SHOSHAD, ANA, VERY CLEAR PRESENTATION AND APPRECIATE YOU AGAIN TAKING THE TIME. >> THANK YOU VERY MUCH. APPRECIATE THE OPPORTUNITY. >> THANK YOU. >> SO LAST UP IS A CONCEPT CLEARANCE WHICH MIGHT LOOK A LITTLE FAMILIAR. PRESENTED BY GAYLE. >> OKAY, SO I THINK THE COUNCIL IS FAMILIAR WITH THE CONCEPT CLEARANCE PROCESS. I KNOW I'M STANDING BETWEEN YOU AND LUNCH BUT I ONLY HAVE 1 SLIDE, SO IT SHOULD BE PRETTY STRAIGHT FORWARD. AT THE LAST COUNCIL MEETING WE ENTERTAINED A NUMBER OF CONCEPTS THAT WERE DISCUSSED AND VOTED ON BY THE COUNCIL. FOR THIS PARTICULAR MEETING, WE HAVE ONLY 1 AND THIS IS THE 1 THAT DR. SZTEIN IN HER PRESENTATION, THIS IS THE ACCELERATING MEDICINE'S PARTNERSHIP AUTOIMMUNE AND IMMUNE MEDIATED DISEASES AMP AIM CONCEPT. THE--WHAT WE WOULD LIKE IS APPROVAL FROM COUNCIL TO MOVE FORWARD WITH ACTIVITIES RELATED TO THIS. AND I'LL ASK MELINDA IF SHE HAS ANYTHING ELSE WE NEED TO ADD WITH REGARD TO WHAT WE NEED FROM COUNCIL. >> NO THAT'S IT. OUR REQUIREMENT IS TO MAKE SURE THAT WE SHARE THIS AND SHARE IT WITH [INDISCERNIBLE] SO IT'S DEFINITELY A REQUIREMENT. >> SO IF ANYBODY HAS ANY CONCERNS? PLEASE SPEAK UP? >> LET'S BE SURE WE'VE GIVEN EVERYONE A CHANCE. DON'T SEE ANY, OKAY, GREAT, THANK YOU. >> YEAH, MELINDA? THANK YOU AGAIN. >> YES, ALL RIGHTY. SO WHAT WE'RE GOING TO DO NOW IS WE'RE GOING TO TAKE A BREAK. THE MORNING SESSION WILL BE OVER AND ONLY THE COUNCIL MEMBERS WILL COME BACK AT 1:30