IT IS MY VERY GREAT HONOR TO CALL THE FIRST MEETING OF THIS ADVISORY PANEL TO ORDER. AND WE'LL BEGIN BY ASKING OUR EXECUTIVE SECRETARY TO DO THE ROLL CALL. >> GOOD MORNING, THANKS TO EVERYONE FOR BEING HERE AND BEING ON THE LINE. I'M GOING TO ANOINT THE PEOPLE WHO ARE IN THE ROOM AND ASK FOR ROLL FOR PEOPLE WHO ARE POSSIBLY ON THE TELECONFERENCE. DR. BRIGGS, THE CHAIR IS IN THE ROM. DR. LONCARTIN IS ON THE ROOM. IS [INDISCERNIBLE] ON THE ROOM. IS TONY COALS ON THE PHONE? IS DR. RORY COLLINS ON THE PHONE? PLURIPOTENT ERIC DISHMAN OKAY. WE'RE EXPECTING ERIC A LITTLE LATER MS. ALEJANDRA GAP. WE'RE EXPECKING HER AS WELL IS DR. MIRANDA ON THE PHONE? IS DR. ROB CALEB ON THE PHONE? OKAY. WE EXPECT HIM TO BE JOINING US IN PERSON A LITTLE LATER IN THE MORNING. IS DR. KAREN DESAVO ON THE LINE? NO. OKAY. WE DO NOT EXPECT HER TO JOIN. WE EXPECT HER ALTERNATE OTHER JOHN WHITE WILL BE JOINING US SOON IN PERSON. IS DR. MAGASIANO ON THE PHONE IN OKAY. WE EXPECT MIKE IS GOING TO BE JOINING US IN PERSON LATER ON IN THE AFTERNOON. >> THANK YOU, GWEN. SO I WANT TO BEGIN BY ASKING ALL OF YOU WHO ARE IN THE ROOM TO INTRODUCE YOURSELVES TO EACH OTHER. GIVE US A SENTENCE OR TWO ABOUT YOUR BACKGROUND AND AREAS OF YOUR OWN EXPERTISE SO NA YOUR COLLEAGUES WILL, I KNOW A PLEASURE OF PULLING TOGETHER THIS PANEL, BUT NOT EVERYONE KNOWS EACH OTHER SO I THINK THAT INTRODUCTION IS IMPORTANT. LET ME TELL YOU JUST VERY BRIEFLY ABOUT MYSELF. I'M A NEPHROLOGIES, I'VE LED A SIZEABLE MEMBER OF SIZEABLE PROJECTS, 2 LONGITUDINAL COHORT STUDIES ON KIDNEY DISEASE. FOR THE LAST SIX YEARS, I'VE SERVED AS THE DIRECTOR OF K. IMPLEMENTARY AND INTEGRATIVE HEALTH AND HAVE GAIN SOME EXPERIENCE IN OUR LEADING RESEARCH THAT IS EMBEDDED IN HEALTHCARE SYSTEMS THROUGH LEADERSHIP OF THE HEALTHCARE NIH COMMON FIND HEALTHCARE COLLABTORY. BUT THERE ARE MANY PARTS OF THIS COMPLEX DOMAIN THAT I'M GOING TO BE DEPENDENT UPON OUTSIDE ADVICE AND EXPERTISE. SO IT'S MY INTRODUCTION. I HAVE ASKED BILL REILLY TO SIRS POO SERVE AS MY DEPUTY. >> THANKS, JOSE, BILL REILLY, I'VE BEEN AT THE NIH FOR ABOUT 10 YEARS AND AUGUST APPOINTED AS DIRECTOR OF THE OFFICE OF BEHAVIOR AND SOCIAL SCIENCES RESEARCH HERE AT THE NIH. I'VE BEEN ENVELOPED IN P.M.I. SPADES I THINK PRETTY CLOSE TO ITS INCEPTION AND SERVING AS AN INTERIM DEPUTY DIRECTOR AND HAPPY TO DO SO. THOUGH LIKE JOSE, I'M HOPEFUL THAT WE FIND PERMANENT FOLKS FOR THESE POSITIONS AS SOON AS POSSIBLE. >> I'M AN AN THESEIOLOGIST BY CLINICAL PRACTICE, DOING LIVER TRANSKNOW PLANT, VASCULAR ANESTHESIA. MY BACKGROUND IS IN ENPHOMATICS. WENT INTO MEDICINE. I LEAD A COUPLE OF INITIATIVES [INDISCERNIBLE] HOLMGREN SYSTEMS AND WE HAVE GOT ABOUT 4 AND A HALF MILLION PATIENT RECORDS ACROSS 20, 30 HEALTH SYSTEMS. AND I'VE BEEN WORKING WITH THE PMI, WONDERING GROUP SINCE FEBRUARY, MENSH, TOO HELP INFORM THE DATA CONCEPTS AROUND AGGREGATION AND HOW TO USE THAT FOR PRAGMATIC TRIALS AND PRAGMATIC COHORT DEVELOPMENT. >> I'M GREG SIMON. CLINICAL TRAINING IS AS A GENERAL INTERNIST, AND NOW, AS A PSYCHIATRIST. I WORK AT GROUP HEALTH INSTITUTE IN SEATTLE. ASK SPEND ABOUT TWO-THIRDS OF MY TIME IN THE RATHER THAN WORLD WHERE I DO MOST OF MY WORK WENT MENTAL HEALTH RATHER THAN NETWORK, IT'S AN NIMH-FUNDED NETWORK THAT BRINGS TOGETHER, 13 HEALTH SYSTEMS, COVER GOING 12 MILLION PEOPLE. SOME LARGE OBSERVATION TRIALS AND PRAGMATIC TRIALS AN AND SERVE FOR THE NATIONAL ADVOCACY FOR PEOPLE WHO LIVE WITH MOOD DISORDER. >> NIH PROGRAM DIRECTOR ACCIDENT I'M TRAINED AS AN INTERNIST, I WAS A PROFESSOR AT CRAWL AND UIN, C CHAPEL HILL. I'VE BEEN HERE FOR ABOUT FIVE YEARS. I HAVE AN ACTIVE RATHER THAN PROGRAM IN CELL PHYSIOLOGY AND I HAVE NO SPECIFIC TRAINING THAT'S RELEVANT TO THIS PROGRAM. BUT JOSE ALLOWED ME TO EXPLAIN WHILE I'M HERE IN A FEW MINUTES. SO WE'LL WAIT. >> I'M DAVID WILLIAMS, A SOCIOLOGIST AT THE HARVARD SCHOOL OF PUBLIC HEALTH AND DEPARTMENT OF AFRICAN-AMERICAN STUDIES AT HARVARD. I HAVE SPENT MY CAREER. LOOKING AT SOCIAL CLASSES. PARTICULARLY, SOCIOECONOMIC AND RACIAL ETHNIC DIFFERENCES IN WHAT ARE THE PATTERNS AND UNDERLYING CONDITIONS OUTSIDE OF THE HEALTHCARE SYSTEM THAT DETERMINE VARIATIONS IN HEALTH. >> I SERVED AS ONE. COCHAIRS OF THE WORKING GROUP THAT WAS RESPONSIBLE FOR DEVELOPING THIS REPORT THAT WE'RE ABOUT TO EXPLORE. I COME TO THIS WORK FROM THE PARTICIPATE ENGAGEMENT SET OF THINGS THE I WAS ORIGINALLY PATIENT IN AN ABORTED CLINICAL TRIAL, THAT FAILED DUE TO SLOW ENROLLMENT, LACK OF ENGAGING PARTICIPANTS AND DESIGN, CONDUCT OVERSIGHT. I WORK AT DUKE UNIVERSITY AS THE DIRECTOR FOR PATIENT ENGAGEMENT AT RTCSA AND THE DIRECTOR OF STAKEHOLDER ENGAGEMENT FOR CLINICAL TRIAL TRANSFORMATION INITIATIVE, AN FDA PUBLIC PRIVATE PARTNERSHIP TO IMPROVE EFFICIENCY OF CLINICAL TRIAL. AND I THINK I'M HERE BECAUSE I PERSPECTIVES TOGETHER AND MAKE SURE WE DO OUR JOB AND DON'T SKIMP ON THE ENGAGEMENT AND REALLY HAVING PARTICIPANTS AS PARTNERS IN THIS COHORT. >> GOOD MORNING, I'M DR. AARON, THE CHIEF EXECUTIVE OFFICER OF THE YWCA OF THE UNITED STATES OF AMERICA, THE WORLD'S OLDEST AND LARGEST MULTI CULTURAL ORGANIZE THAT DEDICATED TO END RACISM AND EMPOWERING WOMEN. I'M A PHYSICIAN BY TRADE AND AN ADVOCATE BY CHOICE. IDENTIFY A VARIED DEGREE OF A FIGURE. I'M AN INTERNEST, AND HAVING TRAINED AT BELL VIEW, THE WORLD'S OLDEST CITY HOSPITAL. I'VE SEEN HEALTH DISPARITIES IN VERY DISTURBING FORM. SO I BELIEVE WHAT I'LL BRING TO THIS GROUP IS AN UNDERSTANDING OF HEALTH, DISPARITIES, AND ALSO ALSO, HOPEFULLY, BE ABLE TO ASSIST AND PARTICIPANT IN ENGAGEMENT AS WELL. >> SHARON KERRY, PRESIDENT AND EOOF -- RANGING FROM CLINICS OF HOSPITALS AND RARE DISEASES AND EVERYTHING IN BETWEEN. I'M HERE IN MY ORIGINS AS A MOM OF TWO KIDS WITH AGENETIC DISEASE WHO WERE DIAGNOSED BETWEEN THE YEARS AGO. I FOUNDED A FOUNDATION AND FOUND ONE OFFING THESE DISEASES WAS NOT GOING TO BE SUCCESSFUL. MOVED TO GENETIC ALLIANCE 14 YEARS AGO AND OUR WORK IS TO TRY AND FIND OUT SYSTEMATIC CHANGE THAT WILL MAKE A DIFFERENCE, LARGELY AFTERNOON GETTING PEOPLE INVOLVED ENGAGEMENT, FIGURING OUT BETTER SYSTEMS INTEGRATION AND BRINGING SOME OF THE STUFF FROM OTHER INDUSTRIES, IN TERMS OF SOCIAL MEDIA OR NOVEL WAYS OF INTERACTING TOGETHER. WE'RE MAKING A CHANGE IN A VERY OLD AND COTTAGE INDUSTRY. >> AND I'M LON CARTIN. I'VE BEEN INVOLVED WITH A WHOLE SET OF THE FOLLOW-ON PROJECTS, THE HUMAN GENOME PROJECT. I WAS ON THE EQUIVALENT OF THE WORKING GROUP FOR THE U.K. BIOBANK. MY GROUP WITH A WHOLE BUNCH OF COLLABORATORS -- SEVEN YEARS AGO, I MADE THE MOVE TO SEE WHAT WE CAN DO WITH ALL THIS GENETIC INFORMATION, AND NOW, I LEAD VARIOUS GROUPS NA WE CALL ALTERNATE ALTERNATIVE DISCOVERY AND DEVELOPMENT TO TRY AND DO THINGS A LITTLE BIT DIFFERENTLY AND REALLY CHANGE THE PARADIGM. >> CAN I ASK YOU TO INTRODUCE YOURSELF PLEASE. >> VAUGHN WHITE, I'M A 10 CLOCK SCHOLAR. [LAUGHTER] I'M THE DEPUTY NATIONAL DEPARTMENT OF HEALTH AND HUMANSERSES. IT HAS BEEN A PRIVILEGE AND HONOR TO WORK WITH SEVERAL OF OUR COLLEAGUES HERE, AROUND THE TABLE FOR THE PAST YEAR IN SHAPING THE PRECISION MEDICINE INITIATIVE. I'M HERE TODAY, IN PLACE OF KAREN DESALVO, MY BOSS, WHO IS THE NATIONAL COORDINATOR OF NIT. IN AN EX-OPH OFFICI O-- EX-OFFICIO CAPACITY. >> HAS ANYONE DIALED IN SINCE WE TOOK ROLE. >> ERIC DISHMAN'S HERE. >> ERIC. JOSE BRIGGS. CAN I ASK TO YOU SPRUCE YOURSELF, PLEASE PLEASE. >> SURE. ERIC DISHMAN. I RUN INTEL HEALTH SCIENCE BUT I'M HERE AS MUCH AS A SOCIAL SCIENTIST WHO HAD SPENT A LOT OF YEARS SPENDING PATIENT-ZAX AROUND THE WORLD, WITH TECH COMPANIES AND I'M A PERSONALIZED BENEFICIARY MEDICINE. I HAD 23 YEARS OF WELL INTENTIONED GUESS WORK TO DEAL WITH ADVANCED CANCER AND FINALLY A A WHOLE GENOME SEQUENCE SAVED MY LIFE AND I CAME BACK AND SAID TO INTEL, I'M GOING TO DO EVERYTHING I CAN WITH MY POWER AND RESOURCES TO HELP ACCELERATE GENOMIC MEDICINE FOR EVERYBODY. I'M THRILLED TO BE BACK WITH THE BAND, AND HAVING NEW MEMBERS OF THE BAND AFTER HAVING NEW MEMBERS WORK ON THIS. >> THANK YOU. WE'RE THRILL WOULD TO HAVE YOUR INPUT. I THINK SO WE HAVE DONE THE INTRODUCTIONS, PANEL MEMBERS WHO ARE CURRENTLY WITH US. THERE ARE A COUPLE OF OTHER KEY INTRODUCTIONS OF THE SORED OF LEADERSHIP TEAM. CARRIE, JOIN US AT TABLE. CARRIE IS THE DIRECTOR OF THE OFFICE OF SCIENCE POLICY AT N.I.H. CARRIE, CAN I ASK YOU TO INTRODUCE YOURSELF, PLEASE? >> SURE. >> ASSOCIATE DIRECTOR FOR SCIENCE POLICY AT NIH AND DIRECTOR AT THE OFFICE OF SCIE POLICY AND OUR OFFICE HANDLES A WIDE RANGE OF BIOMEDICAL RESEARCH POLICY ISSUES AND IS WORKING SORT OF ACROSS THE BOARD ON THE POLICY ISSUES RELATED TO THE PRECISION MEDICINE COHORT PROGRAM AND YOU'LL BE HEARING A LITTLE BIT MORE ABOUT THAT LATER ON IN OUR AGENDA. >> I ALSO WANT TO INTRODUCE JOHN BURKLO AND MELISSA COTLER. THEY'RE OUR LEADS FOR COMMUNICATION ACTIVITIES. THIS IS JOHN, THIS IS MELISSA, IN THE CLOSED SESSION TOMORROW MORNING, WE WILL BE, ONE OF THE THINGS WE WILL BE REVIEWING TOGETHER IS THE RESPONSE TO SOLICITATION FOR COMMUNICATION ACTIVITIES, AND TASK THE LEADS IN THAT ACTIVITY. AND NOW, I WANT TO INTRODUCE SOME OF THE KEY MEMBERS OF OUR TEAM. I'LL START BECAUSE I KNOW THEY WOULDN'T TELL YOU THEIR QUALIFICATIONS, BUT I'VE ACTUALLY, AND THEN THEY MAY ADD THINGS OR CORRECT ME IF I DON'T CORRECTLY SUMMARIZE THEIR BACKGROUNDS BUT I'VE BEEN BIZLY PULLING TOGETHER A SUPUSH GROUP OF VOLUNTEERS TO HELP IN THIS INTERIM PERIOD IN ADDITION TO A LISA AND JOHN. GWEN JENKINS IS OUR EXECUTIVE SECRETARY. SHE'S WELL KNOWN TO EVERYONE WHO IS PART OF THE ACD WORKING GROUP BECAUSE SHE IS THE TRUE AUTHOR OF THAT REPORT. AND HAS BEEN THE REAL POLICY LEAD AND GLUE IN THIS PROJECT FROM THE START I'M VERY DELIGHTED TO HAVE PERSUADED DEB KAZILKY TO HAVE JOINED US. SHE IS A VERY EXPERIENCED PERSON OF ADMINISTRATIVE PROCESSES AT THE N.I.H. SHE IS ONE TIME WITH THE BUDGET OFFICER BUT LED AN EXTENSIVE TRANSFORMATION OF THE TECHNOLOGY TRANSFER OFFICE IN BUILDING 1 AND IS VERY FAMILIAR WITH ALL ASPECTS OF HOW WE GET WORK DONE HERE IN THE GOVERNMENT, A VERY KEY MEMBER OF OUR TEAM. ACTING AS THE LEAD FOR THE PROGRAM ACTIVITIES IS JOANIE RUTTER. SHE ACTUALLY HAS A DAY JOB AS WELL. SHE DIRECTS BASIC SCIENCE DIVISION IN THE NATIONAL INSTITUTES OF DRUG ABUSE BUT SHE HAS BEEN REALLY, THE CRITICAL LEAD IN PULLING TOGETHER THE PROGRAM EXPERTISE, TOO PUT TOGETHER THE RFA'S THAT I THINK YOU'RE GOING TO HEAR MORE ABOUT TODAY, WHICH HAVE INVOLVED INPUT FROM MANY, MANY TEAM. LEADING THE ACTIVITIES RELATED TO THE DIRECT VOLUNTEER'S PILOT, WE HAVE RECRUITED JAMES MCCAIN, HE'S SITTING RIGHT THERE. HE'S FROM THE NATIONAL CANCER INSTITUTE. JAMES, STAND UM AND MAKE SURE EVERYBODY SEES YOU. JAMES HAS BEEN BROUGHT INTO THIS EFFORT BECAUSE OF SUBSTANTIAL EXPERSE IN I.T. INTERFACING IN WORK. BRINGING EXPERTISE IN THE GENOMICS ASPECTS OF THE WORK IS CAROLYN HUDDER. SHE IS FROM THE GENOME INSTITUTE, WHERE SHE'S HAD A SUBSTANTIAL ROLE IN A LARGE NUMBER OF PROGRAMS AND IS SORRY EXPERIENCED ON THE MANAGEMENT OF LARGE GENOMIC PROJECTS. AND GINA WAY ALSO HAS TAKEN ON A LARGE ROLE IN THE DEVELOPMENT OF ERFA'S. GINA IS FROM THE HEART BLOOD AND LUNG INSTITUTE AND HAS EXPERIENCE IN LAUNCHING COHORT STUDIES AND SHE HAS BEEN VERY ACTIVELY INVOLVE IN PROVIDING IN THAT. NOT HERE YET IS REBECCA RESULI FROM DIGESTIVE AND KIDNEY DISEASE. REBECCA WILL BE OUR LEAD FOR ALL ASPECTS OF OUR BIOBANK. SHE LEADS LARGE BIOBANK FROM D.K. AND HAS PRINTOUT TOGETHER A GROUP WITH BIOBANKING EXPERTISE. IN THE GREEN SHIRT IS CATHERINE, PART OF OUR COMMUNICATIONS GROUP, BUT HAS BEEN ACRITICAL PERSON IN ALL THE CORRESPONDENTS, INCLUDING ANSWERING MANY PEOPLE WHO ARE INTERESTED IN THIS PROJECT AND WE HAVE A VERY EXCONTINUOUSIVE CORRESPONDENTS DEMAND BECAUSE OF THE GREAT PUBLIC INTEREST, AND SHE'S LEADING THAT. SO THAT'S THE CURRENT TEAM. LARGELY VOLUNTEERS AT THIS POINT. THE FULL TIMERS HAVE BEEN, AND GO WEN AND BILL AND I ARE NOT FULL TIMERS. IT KIND OF FEELS THAT WAY. THERE'S A VERY ACTIVE SEARCH GOING ON FOR A PERMIT DIRECTOR. SHARON AND BRAY ARE MEMBERS OF THE COMMITTEE LOOKING AT THAT, AS WELL AS A NUMBER OF OTHER PEOPLE WITH EXTENDIVE EXPERIENCE IN THIS GENERAL DOMAIN AND WE ARE GUARDEDLY OPTIMISTIC THAT THERE WILL BE A DIRECTOR IN PLACE, WITHIN A COUPLE MONTHS. AND MY INTENT AT THIS POINT, IS TO GET A WORKING TEAM IN PLACE WHILE SIMULTANEOUSLY ALLOWING THAT PERSON THE OPTIMUM FLEXIBILITY TO BUILD A TEAM NEEDED TO GET THIS WORK DONE. SO THAT'S WHY WE'RE GETTING THE POSITION DESCRIPTIONS AND OTHER THINGS IN PLACE. BUT WE ARE NOT DOING MUCH PERMIT HIRING YET. SO THAT'S AN INTRODUCTION OF OUR TEAM AND WHERE WE ARE AT THE PRESENT TIME. AT THIS POINT, I'D LIKE TO TURN TO JIM ANDERSON. HE WILL EXPLAIN THE RELATIONSHIP OF THIS GROUP WITH THE COUNCIL DR. ANDERSON. >> THANK YOU, JOSE, GOOD MORNING AND IT'S A PLEASURE TO JOIN YOU FOR THE PANEL MEETING TODAY. THANKS FOR YOUR SERVICE ON THIS IMPORTANT PANEL, ALCOHOL PROVIDE TH-- ALCOHOLPROVIDE EXPERTISE. -- WHICH WILL PROVIDE EXPERTISE. OUR DIVISION CONTAINS AT THIS POINT, 11 OFFICE THAT IS COORDINATE ACTIVITIES WITHIN VERY BROAD TRANSNIH ST. PETERS BASILICA THEMES LIKE WOMEN'S HEALTH, BEHAVIORAL SOCIAL SCIENCE RESEARCH, I'LL POINT OUT BILL REILLY IS THE NIH DIRECTOR OF RESEARCH AND DIRECTOR OF THAT OFFICE IN OUR DIVISION. THE DIVISION IS ADVISED BY A CHARTED ADVISORY COMMITTEE, WHICH I CHAIR CALLED THE COUNSEL OF COUNCILS, WHICH PROVIDES ADVICE TO THE NIH DIRECTOR AND ME, ON OUR DIVISION AND ON TRANSNIH RATHER THAN ACTIVITIES. MANY OF OUR COUNCIL MEMBERS ARE SIMULTANEOUSLY MEMBERS OF INSTITUTE AND CENTER ADVISORY COUNCILS. SO THE PMI COHORT PROGRAM IS AE TRANSNIH P ROGRAM, IT'S NOT AN INSTITUTE-SPECIFIC PROGRAM. SO IT'S WHY YOUR PANEL IS BEING FORMED AS A WORKING GROUP AS THE COUNSEL OF COUNCILS SO YOUR RECOMMENDATILL BE PRESENTED TO THE NIH. THROUGH A COUNCIL THAT HAS THINKING OF TRANSNIH AND BROAD PERSPECTIVE. YOU'LL SPEND EFFORTS WORKING WITH THE PMI COHORT PROGRAM DIRECTOR AND STAFF. BUT WHEN YOU PROVIDE RECOMMENDATIONS ON NEW PROGRAM DRECKS, WHAT TO SPEND TAXPAYERS' DOLLARS ON AND WHAT TO PEN, I WILL HELP YOU INNER SEED WITH THE COUNSEL OF COUNCILS SO THEY CAN CONCUR WITH YOUR RECOMMENDATIONS. SO I DON'T WANT TO GET INTO A LOT OF ADMINISTRATIVE DETAILS WITH THIS RELATIONSHIP, BUT I CAN ANSWER ANY QUESTIONS. >> SO I THINK AS ALL OF YOU ARE AWARE, THIS IS AN IMPORTANT PART OF NIH'S STRUCTURE OF DECISION MAKING IS THE USE OF PEER REVIEW PANELS. ADVISORY PANELS AND THEN ULTIMATELY FORMAL BODIES THAT ARE SET UP AS COUNCILS. AT THIS POINT, WE HAVE NOT MADE ALL OF YOU SPECIAL GOVERNMENT EMPLOYEES. BE THANKFUL FOR THAT. THE PAPERWORK HURDLES ASSOCIATED WITH BEING AN SGEARE IN FACT, PAINFUL FOR EVERYBODY. AND IT OFTEN TAKES THREE MONTHS TO GET IT DONE AND WE DID DECIDE, SETTING UP A FORMAL BODY WAS CUMBERSOME WAS CUMBERSOME AT THIS STAGE. THE COUNSEL OF COUNCIL HAS A BROAD PERSPECTIVE, 30,000 FEET PERSPECTIVE, I THINK IN GENERAL, AND OVER TIME, IN THE NEXT PANEL FOR COUNSEL OF COUNCILS IS NAMED, WE WILL HAVE ONE OF THE MEMBERS OF THIS ADVISORY PANEL, ALSO SERVE AS A MEMBER OF THE COUNSEL OF COUNCILS, ALTHOUGH THERE IS NO STRICT REQUIREMENT FOR THAT. THAT WILL HELP US ENSURE THAT WE HAVE LEVELS OF DELIBERATIONSES, THAT ARE APPROPRIATE AND INTEGRATED. AND I THINK THIS IS CREATING A GOVERNANCE STRUCTURE TO HAVE THE FUTURE PROPONENT DIRECTOR TO HAVE THE ADVICE FROM THE KIND OF EXPERTISE THAT YOU SEE IN THIS ROOM AND YET, HAVE DECISION MAKING PROCESS THAT'S PROPERTILY, CREATES FLEXIBILITY. THIS AFTERNOON, WE'RE GOING TO REALLY DELVE INTO SOME OF THE PLANNING ASPECT THAT NEED TO GO ON FROM HERE AND WE'LL AGAIN RETURN TO TALKING ABOUT GOVERNANCE AND WHO'S MAKING WHAT DECISIONS BECAUSE THAT IS COMPLEX IN A BIG PROJECT LIKE THIS AND I'D LIKE TO YOU HEAR OUR CURRENT THINKING ABOUT THAT. AND TO GET YOUR CONTINUED INPUT INTO WHAT WE ENVISION AS THE PROCESS, FOR EXAMPLE, PROTOCOL. IT REQUIRES A CERTAIN AMOUNT OF DEPTHNESS AT NIH LEADERSHIP TO ENGAGE PEOPLE AT THE RIGHT LEVEL TO NOT HAVE PEOPLE TOO FAR IN THE WEEDS OR TOO FAR AT 30,000 FEET PHYTOTOMIES IMPORTANT ISSUES AND I WELCOME INPUT FROM ALL OF YOU, AS TO HOW WE'RE DOING AND WHETHER WE'RE GETTING THAT RIGHT. SO ANY OTHER QUESTIONS FOR JIM OR ABOUT THIS ASPECT OF OUR ADMINISTRATIVE STRUCTURE? >> GREG SIMON. IT'S SORT OF A PARLIAMENT TREE QUESTION. I'M ACCUSTOMED TO THIS RULE THAT, DISCUSSIONS ABOUT STRATEGIES, LONG-TERM, POTENTIAL FUNDING OPPORTUNITIES BELONG IN OPEN SEGREGATED, WHILE ANY DISCUSSION ABOUT PLUGS UNDER CONSIDERING, PENALLING, BELONGS IN CLOSED SESSION. WITH SOME OF THESE ISSUES, WE'RE SORT OF IN AN IN-BETWEEN PHASE, WHERE FUNDING OPPORTUNITIES OF COURSE ANNOUNCED, PEOPLE ARE CONSIDERING THEM, APPLICATIONS HAVE NOT BEEN RECEIVD. THERE ARE NO APPLICATIONS UNDER CONSIDERATION. IF WE HAVE THOUGHTS ABOUT PRIORITIES, ABOUT WHAT'S IMPORTANT FOR THOSE PROGRAMS, ARE THOSE OPEN SESSION OR CLOSED SESSION QUESTIONS? >> RIGHT. SO AS YOU CORRECTLY INDICATE, THESE ISSUES CAN, THERE CAN BE A GRAY ZONE. WE ARE IN FACT, IN CLOSED SESSION THIS AFTERNOON AT 2:30. WHERE WE WILL TALK ABOUT THE OTHER TRANSACTIONS AUTHORITY AWARDS THAT ARE EMINENT AND THIS AFTERNOON WE WILL INTRODUCE THE BACKGROUND FOR THOSE AND TOMORROW'S WORK WILL INVOLVE CONSIDERATION OF THOSE TWO AND THAT'S WHERE WE'LL BE TALKING ABOUT SPECIFIC APPLICATIONS. YOU'RE ABSOLUTELY CORRECT THAT WE HAVE A [INDISCERNIBLE] PHASE ON THE STREET, AND THOSE ARE VERY ACTIVE INTEREST TO OUR APPLICANT COMMUNITY. THEY'RE ALREADY OUT AND DRASTIC MODIFYING IN THOSE ARE NOT REALLY POSSIBLE AT THIS STAGE, BUT THERE ARE MANY ASPECTS OF THE WORK THAT WILL BE DONE UNDER THOSE, THAT ARE SUITABLE, I THINK FOR OUR CONVERSATIONS TOGETHER AND WE'LL BE TO GO THAT IN OPEN SESSION DURING THE DAY. BUT IN CIRCUMSTANCES WHERE IT IS IMPORTANT TO RAISE THE QUESTION IS THIS AN OPEN SEGREGATED OR CLOSED SESSION DISCUSSION, AND I'LL BE HAPPY TO TRY TO ADDRESS THOSE IN HERE AND HERE ARE YOUR THOUGHTS ON THAT. ANYMORE QUESTIONS ABOUT THAT AREA OR OTHER TOPICS ABOUT OUR COLLECTIVE CHARGE RIGHT NOW? >> GOOD. SO AT THIS POINT. 15 MINUTES AHEAD OF SCHEDULE. >> MAYBE WE'LL COME IN UNDER BUDGET, TOO. [LAUGHTER] WE'LL NOW TURN TO -- A NUMBER OF YOU WERE PRESENT AND PART OF THE ACD WORKING GROUP DELIBERATIONS. OTHERS WERE -- WELL, PARTS OF T. WE FELT THE FIRST STEP IN OUR CONVERSATIONS TOGETHER WAS TO REVIEW THAT WHOLE PROCESS AND WHERE THAT ADVISORY PROCESS GOT US, AS OF SEPTEMBER 17, WHEN THAT REPORT WAS FINALIZED AND DELIVERED TO THE NIH DIRECTOR AND PROVED BY THE ADVISORY COMMITTEE TO THE DIRECTOR. AS I MENTIONED EARLIER, GWEN JENKINS WAS THE EXECT FOR THAT. AND WAS ACRITICAL PERSON IN CONCEPTUALIZING MANY ASPECTS OF T SO I ASKED GWEN TO GIVE THE INITIAL SUMMARY OF THAT PROCESS. >> GWEN: GREAT. THANK YOU. AND IT'S SUCH A PLEASU TO BE BACK AGAIN AND HAVE THE OPPORTUNITY TO CONTINUE WITH THE PROGRAM. I THINK EVERYONE WHO HAS BEEN INVOLVED BECOMES SO INVESTED IN WHAT'S REALLY GOING TO BE A TRANSFORMATIONAL INITIATIVE, THAT, YOU KNOW, HAVING THE OPPORTUNITY TO CONTINUE TO BE INVOLVED IS REALLY AN HONOR. AND SO JOSIE AND I ARE GOING TO BE TAG TEAMING THIS SLIDE SO I'M GOING TO DO THE FIRST PART. FOR FOLKS IN THE ROOM WHO ARE PART OF THE PROCESS, WE'RE GOING TO BE OPENING IT UP FOR YOU TO ADD YOUR OWN THOUGHTS ABOUT WHAT THE WORKING GROUP EXPERIENCE WAS, WHAT OUR CONSIDERATIONS WERE AND YOUR THOUGHTS ABOUT THE REPORT SO. >> TALK TALK WAY. -- I'M GOING FOR THE BENEFIT OF THE DIVERSITY OF CONTACT WE HAVE IN THE ROOM, WITH THE PRECISION MEDICINE INITIATIVE AND ON THE VIDEO CAST AS WELL. AND SO OF COURSE, YOU KNOW, THE CHALLENGES THAT KIND OF BROUGHT US TO THIS PLACE THAT WE KIND OF STARTED WITH OR WE HAVE HAD FOR A LONG TIME THAT, WE'RE CERTAINLY AWARE OF, START FRIDAY LAST JANUARY THAT MANY DISEASES, LACK OF EFFECTIVE PREVENTION, STRATEGIES, DIAGNOSTICS OR TREATMENTS AND REALLY LACK THE INDIVIDUALIZED APPROACH THAT BEING BRING MUCH GREATER ADVOCACY TO THEM. PARTICIPANTS IN BIOMEDICAL RESEARCH ARE OFTEN TREATED AS SUBJECTS, RATHER THAN THAN AS PARTNERS. RATHER THAN FINDINGS OFTEN TAKE FAR TOO LONG TO IMPLEMENT INTO CLINICAL PRACTICE AND AS WELL, THE RECOGNITION WHERE WE ARE IN TERMS OF THINKING ABOUT PERSONALIZED AND PROGRESSION MEDICINE, VERY GENOMIC FOCUSED BUT REALLY NEEDS TO BE AN APPROACH THAT GOOD BEYOND THE SCREEN NOPE. SO ALMOST A YEAR AGO TODAY T PRESIDENT OBAMA ANNOUNCED DURING HIS STATE OF UNION ADDRESS, HIS INTENTION TO FORM THE PRECISION MEDICINE INITIATIVE. I JUST WANTED TO KIND OF, AS A REPRISE, PLAY THIS FOR YOU. >> TONIGHT, I'M LAUNCHING A NEW PRECISION MEDICINE INITIATIVE TO BNG US CLOSE TORE CURING DISEASES LIKE CANSER AND DIABETES, AND GIVE ALL OF US ACCESS TO THE PERSONALIZED INFORMATION WE NEED TO KEEP OURSELVESES AND OUR FAMILY HEALTHIER. WE CAN DO THIS. >> THE MIRACLE OF BIPARTISAN SUPPORT, MANIFESTED IN THIS CLIP. OF COURSE, WE GOT A NICE SHOT OUT FROM THE PRESIDENT DURING THE LAST STATE OF UNION ADDRESS, AND WE CONTINUE TO HAVE STRONG BIPARTISAN SUPPORT FOR THE INITIATIVE. THIS SLIDE USED TO SAY "PROPOSED 2016 FISCAL YEAR BUDGET" AND NOW, IT JUST SAYS "BUDGET" BECAUSE THIS IS WHAT WE HAVE. THE PRESIDENT'S INITIATIVE MEDICINE. ONE OF THE REASONS WE'RE ALWAYS CAREFUL TO TALK ABOUT WHAT WE'RE DOING AS A PMI COHORT PROGRAM IS BECAUSE THERE ARE MANY COHORTS TO THE PRESIDENT'S TOTAL PMI WRIT AT LARGE. INCLUDING THE NIH. SO $130 MILLION, FOR WHAT WE'RE HERE TO TALK ABOUT TODAY, ANOTHER $7 MILLION FOR OUR PARTNERS AT NCI, WHO ARE DOING ANOTHER PMI FOR ONCOLOGY, AND THEN THE FDA AND THE ONC, AS WELL, ARE PART OF THE PRECISION MEDICINE INITIATIVE. DRAWN IN, NOT BUDGETED, BUT DRAWN IN AS WELL ARE PARTNERS IN CMS AND THE VETERAN'S ADMINISTRATION, AND IN OTHER AREAS, IN TERMS OF LOTS OF POLICY DEVELOPMENT. SO THE PMIVERY LARGE CROSS AGENCY INITIATIVE. A REMINDER ABOUT WHY THIS IS THE RIGHT TIME TO DO IT. FRANCIS COLLINS OUR DIRECTOR WAS VERY INTERESTED IN DOING A PERSONALIZED MEDICINE PROJECT 10 YEARS AGO, AND SO, AND PROPOSED IT AND IT REALLY DIDN'T GET MUCH LEGS BUT WHEN YOU LOOK AT THE THE COST AND AMOUNT OF TIME IT TAKES TO DO SEQUENCING HAS REDUCED EXPONENTIALLY. THE NUMBER OF SPLATTER PHONES THAT WE HAVE IN THE UNITED STATES, MANY COMPUTERS TO STAY CONNECTED HAS INCREASED DRAMATICALLY, AND IS SURPRISINGLY YOU KNOW, KIND OF EEGALITARIAN, IN TERMS OF ITS UPTAKE. EHR ADOPTION RATES ARE HUGE. AND THE EXPECTATIONS FOR INDIVIDUALS IN TERMS OF BEING ENGAGED, PATIENTS IN THE CLINICAL SETTING AND BEING ENGAGED PARTICIPATES IN RESEARCH CONTINUES TO RISE DRAMATICALLY AND SO THIS IS KIND OF A PERFECT NEXUS FOR LAUNCHING THE PMI, AS IT'S BEEN UNDERSTAND. I THINK PROPOSED BY THE PRESIDENT, AND INTERPRETED AND BEING IM-- INTERPRETED BY THE WORKING GROUP AND IMPLEMENTED BY THE NIH. SO I AMED TO SHARE WITH YOU SOME OF CORE VALUES THAT OF COURSE ARTICULATED BY THE WHITE HOUSE AND VERY MUCH EMBRACED BY THE NIH IN TERMS OF BEING PMI WHITAKER VALUES. SO PARTICIPATION IS OPEN TO WE WANT EVERYBODY WHO WANTS TO BE PART OF IT, TOO WELCOMED IN THE DOOR. WE WANT TO REPRESENT THE RICH DIVERSITY OF AMERICA. THAT'S ESSENTIAL. WE CONSTRUE PARTICIPANTS OF PARTNERSHIPS IN ALL PHASES OF THE COHORT PROGRAM AND THAT'S A STRONG COMMITMENT, AS I'M SURE YOU SAW IN THE WORKING GROUP REPORT, TO THE FACT THAT PARTICIPANTS GET ACCESS TO INFORMATION AND OUR MANDATE FROM THE PRESIDENT ALL THROUGHOUT THE WORKING GROUP PROCESS, IS IF THERE'S INFORMATION THAT'S NOT GOING TO GO BACK TO PARTICIPANTS, YOU NEED TO COME BACK TO KNEE PERSONALLY, BARACK OBAMA AND TELL ME WHY THAT IS. A HUGE, VERY DEEP AND STRONG MANDATE TO BE OPEN AND STRANDS PARENT WITH STUDY INFORMATION AND DATA. FOR DATA TO BE ACCESSIBLE BROADLY FOR RESEARCH PURPOSES, THIS INCLUDES MAKING AS MUCH DATA AS REASONABLY AND SECURELY CAN BE MADE FOR CITIZEN SCIENCE. ADHERENS TO THE PMI PRIVACY PRINCIPLES, DEVELOPED THAT YOU A WORKING GROUP IN THE WHITE HOUSE. AS WELL AS THE SECURITY FRAMEWORK THAT IS, I THINK -- HAS IT BEEN RELEASED YET OR IS IT JUST CLOSE? THE POTENTIAL FOR THE WORK THAT'S GOING TO BE DONE, CAN CHANGE AND CATALYZE AND THINKING ABOUT ACCESS TO PARTICIPATION, RESEARCH DATA, THINKING ABOUT HOW WE COLLABORATE AND HOW WE PROMOTE HEALTH IS TRULY TRANSFORMATIONAL. SO FRANCES ESTABLISHED THE WORKING GROUP OF HIS ADVISORY COMMITTEE TO THE DIRECTOR ON NUMBER OF PEOPLE WHO ARE ON THAT WORKING GROUP ARE HERE IN THE ROOM. NA GROUP VERY QUICKLY GOT TO WORK. IT'S CHARGED TO DEVELOP A VISION FOR THE PMI COHORT PROGRAM AND TO ADVISE ON HOW DO WE CREATE A COHORT OF A MILLION OR MORE VOLUNTEERS. THESE ARE SOME OF THE VERY HIGH-LEVEL QUESTION THAT IS CAME UP FOR US AGAIN AND AGAIN. HOW DO WE DO THIS. DO WE LEVERAGE EXISTING RESOURCES. DO WE INDICATE SOMETHING THAT'S HYBRID. HOW DO WE CAPTURE THAT RICH DIVERSITY IN ALL OF ITS MANIFEST EGGS. WHAT KIND OF DATA TYPES DO WE INCLUDE. WHAT KIND OF POLICIES. TO BE MAXIMUM BENEFICIAL. SO WE HAD A NUMBER OF INPUTS THROUGHOUT THE PROCESS. THESE CAME UP IN QUICK SUCCESSION. WE HAD FOUR MAJOR NATIONAL WORKSHOPS IN A PERIOD OF FOUR MONTHS. TWO RFI'S THAT WENT OUT, THE FNIH CONDUCTED A SURVEY OF PUBLIC PER ACCEPTINGS OF A PRECISION MEDICINE COHORT. I'LL GIVE YOU A PICTURE OF SOME OF THE DATA. AND THE WHITE HOUSE DEVELOPED TRUST AND PRINCIPLES. THE CUTER FRAMEWORK WAS PULLED OUT OF THAT, SO IT COULD HAVE ITS OWN PROCESS AS WELL. AND THIS IS WHAT I WANTED TO SHARE WITH YOU. WE THINK THIS IS AMAZING DATA. SO THE FNIH SURVEY OF PUBLIC OPINION FOUND THAT, ANDS IN A REPRESENTATIVE SAMPLE. BEAUTIFULLY DONE RESEARCH, COMPARATIVE WITH RATHER THAN THE FNIH HAS DONE BEFORE. YOU KNOW, 80% OF PEOPLE ESSENTIALLY FELT THE RATHER THAN SHOULD BE DONE THAT'S BEING PROPOSED. OVER HALF SAID THEY PROBABLY OR DEFINITELY WOULD PARTICIPATE IN SUCH A COHORT. AND WHAT MOTIVATED THEIR INTEREST WAS OFTENTIMES, GETTING RESULTS. GETTING THAT DATA BACK. HAVING ACCESS TO DATA AND AS WELL AS ALTRUISM. WISHING TO ADVANCE HEALTH RESEARCH, AND AGAIN, VERY STRONG COMMITMENT TO PARTNERSHIP, TOO BEING ENGAGED AND BEING TRULY THERE, YOU KNOW, WITH THE REACHERS, MAKING THIS INITIATIVE A SUCCESS. SO THE WORKING GROUP ISSUED ITS REPORT ON SEPTEMBER 17. EVERYBODY HAS COPIES OF T. ACCESSIBLE AT THE TABLE. AND SO WHAT DID THE WORKING GROUP COME UP WITH? >> WELL, ONE OF THE FIRST THINGS WE WANTED TO DO IS SAY, WHAT ARE WE BUILDING TOWARDS, WHAT KIND OF SCIENTIFIC OPPORTUNITIES, DO WE WANT TO BE SURE WE CAN ANSWER. THIS ISN'T A MANDATE FOR RESEARCH BUT A PRESSURE TESTING OF CONCEPTS, FROM THE BUILD THAT WE'RE PROPOSING IN THE REPORT AND YOU CAN SEE, THAT'S A WIDE DIVERSITY OF OPPORTUNITY THAT IS WE'RE LOOKING FOR AND THEY RANGE FROM BEING SURE THAT STUDY PARTICIPANTS ARE EMPOWERED WITH DATA AND INFORMATION TO IMPROVE THEIR OWN HEALTH, TOO DISCOVERING NEW DISEASE CLASSIFICATIONS. LEARNING HOW TO SUCCESSFULLY AND EMPIRICALLY DEMONSTRATE THE USE OF MOBILE HEALTH TECHNOLOGIES, AND CAN BE HELPFUL GOING FORWARD. BIOLOGICAL MARKERS. NEW WAYS TO USE FARM CODE GENOMICS, ET CETERA. SO WE WERE LOOKING AT SOME BROAD KINDS OF RATHER THAN THAT WE THOUGHT THE BUILD OUGHT TO BE ABLE TO SUPPORT. SO THIS IS THIS IS A HIGH-LEVEL PICTURE OF 90-PLUS RECOMMENDATIONS THAT ARE IN THE REPORT. WHAT THE WORKING GROUP CAME OUT AND SIDES, ONE OF THE QUESTIONS WAS, IS A MILLION THE RIGHT NUMBER. THE WORKING GROUP SAID, ABSOLUTELY. WE WANT A MILLION OR HOPEFULLY MORE, U.S. VOLUNTEERS, THEY MUST REFLECT THE DIVERSITY OF THE UNITED STATES, AND THIS INCLUDED IMPORTANTLY FOR THE DELIBERATIONS, FAMILY MEMBERS FOR ALL AGES. ONE OF THE BIG QUESTIONS WAS, DO WE INCLUDE CHILDREN IN THIS AND THE ANSWER WAS A DEFINITIVE YES. WE'RE GOING TO BE TALKING ABOUT WHAT ARE SOME OF THE CHALLENGES TO THAT AND HOW DO WE GO ABOUT MAKING THAT HAPPEN. WE WANT ALL HEALTH STATUSES. WE DON'T JUST WANT HEALTHY AND PEOPLE WITH DISEASE OR SPECIFIC DISEASE COHORTS. WE WANT EVERYBODY. WE WANT ALL AREAS, GEOGRAPHIC AREAS OF THE UNITED STATES, AND WE WANT A STRONG FOCUS ON UNDER REPRESENTED GROUPS. , TAB THE RECOMMENDATION OF THIS, MUST BE A LONGITUDINAL COHORT. WE'D LOVE TO SEE 10 YEARS OUT OF THIS COHORT. AND WE'D LOVE TO SEE IT CONTINUE AFTER 10 YEARS. PEOPLE HAVE TO BE RECOMPACTABLE FOR SECONDARY STUDIES. WE ANTICIPATED CHECKING BIOSPECIMENS, AND SURVEY DATA STORAGE AS AND A COMPLETE BASELINE EXAM, WHICH WE'RE CALLING A PHYSICAL VALUING AND WORKING GROUP CAME UP WITH A PROPOSAL FOR TWO METHODS OF ENROLLMENT. FIRST, DIRECT VOLUNTEER. WE WANTED TO BE SURE IN THE WORKING GROUP'S REPORTS THAT NT TO BE PART OF THIS ANYONE CAN RAISE THEIR HAND AND COHORT AND HAVE A WAY INTO T. THE SECOND OF THE THAT WE USE HEALTHCARE PROVIDER ORGANIZES INCLUDING HEALTH CENTERS WHICH SERVE THE VAST MAJORITY OF VULNERABLE POPULATIONS IN THE U.S.ING AND THEY SHOULD BE EXPECTED TO BRING IN DIVERSE PARTICIPANTS BE ABLE TO PROVIDE PARTICIPANT FOLLOW-UPS. AND SUBSTANTIAL PARTICIPATION ENGAGEMENT, NOT JUST KIND OF THE FINAL GETTING PEOPLE IN THE DOOR AND YOU'RE PART OF IT, BUT WE WANTED PARTICIPANTS TO BE PART OF THE DEVELOPMENT OF THE PMI COHORT CONCEPT, THE IMPLEMENTATION, AND THE GOVERNANCE. AND THE BENEFITS OF THIS APPROACH ARE SOMETHING THAT WE THOUGHT A LOT ABOUT. WE WANT SOMETHING THAT IS LARGE AND DIVERSE. WE WANT A COHORT THAT'S LARGE AND DIVERSE, YOU KNOW, A REPRESENTATIVE SAMPLE IS RARELY ACHIEVABLE. WHAT WE'RE PROPOSING IS LES COSTLY AND LES DIFFICULT. BUT ABLE TO GENERATE GOOD ESTIMATES FOR AFFECT AND ASSOCIATE AND PERMITTING SAMPLES. THE APPROACH WE'RE TAKING SETTLEMENTS THE WORKING GROUP. AGAIN, IT'S CONSTING ATE WITH THE UNDER SERVED POPULATIONS AND GIVES AN KNOWINGS OF RESISTANCE AND DEVELOPMENT OF DISEASES. IT IS BEENED TO COMPLEMENT B YOU NOT TO DUPLICATE, EXISTING DISEASE COHORTS. THERE WILL BE A RELATIONSHIP WITH A WONDERFUL, ENRICHED COHORTS THAT ARE OUT THERE RIGH NOW FOR DISEASE-SPECIFIC RATHER THAN, BUT THIS IS NOT A DISEASE-SPECIFIC ROACH APPROACH THAT WE ARE EXECUTING IN THE PMI COHORT PROGRAM. SO THE INITIAL CORE DATA SET WAS PROPOSED IN THE WORKING GROUP REPORT AS BEING KIND OF A HYBRID APPROACH OF CENTRALLY CONNECTED CORE DATA, AT A COORDINATING CENTER, AND FEDERATED DATA AS WELL. IN OUR APPROACH RECOMMENDATION WAS TO ARC LINE WITH OTHER DATA SETS WHENEVER POSSIBLE AND LEVERAGE EXISTING STARNS AND EXOAT DATASELF-REPORTED MEASURES, BASELINE ES, BIOSPECIMENS AND HEALTH DATA SO THIS IS KIND OF A VISUAL MUCH HOW WE ANTICIPATED OR HOW THE WORKING GROUP PROPOSED THE DATA FLOW. WE UNDERSTOOD KIND OF DIRECT VOLUNTEER SO THOSE THAT ARE ANYWHERE IN THE U.S. HOLDING UP THEIR HANDS TO BE PROVIDING THEIR OWN SELF-REPORTED MEASURES AND HEALTH DATA CONSENT AND WHEN IS IS SOMETHING THAT IS NOT KNOW FOR RIGHT NOW, THAT'S COMING BUT THAT THE ONE OF THE OBJECTIVES, ONE OF THE GOALS THAT THE RECOMMENDATIONS INCLUDED AND THROUGH THEIR INTERACTION WITH THE HEALTHCARE PROVIDE EVERY, PROVIDING A BASELINE EXAMINE B. SO THE VOLUNTEERS ARE GETTING THE SAME DATA. BUT IT'S COMING IN THAT YOU SLIGHTLY DIFFERENT WAYS. WE ANTICIPATE THE HEALTHCARE PROVIDER WILL BE PROVIDING EHR SPADES DATA. AND WE SEE, YOU KNOW, THIS DATA COMING OUT INTO A BEAUTIFUL CLOUD OF BIG DATA AND SOME OF THE DATA SOURCES THAT ARE REVIEWED IN THE COHORT ARE INCLUDED HERE. I WANTED TO DRAW OUT YOUR PARTICULAR ATTENTION TO THIS ROW, SECOND TO THE BOTTOM. GEOSPATIAL AND ENVIRONMENTAL DATA INCREDIBLY IMPORTANT COMPONENT OF THIS, WE'RE NOT JUST LOOKING FOR CLINICAL DATA WE'RE LOOKING FOR GEOSPATIAL, BEHAVIORAL INFORMATION AS WELL. SO DIVERSE DATASET. AND IN TERMS OF THE INFORMATION FLOWING OUT, WHICH IS ACRITICAL PART OF WHAT WE WANT TO ACCOMPLISH FOR THIS COHORT WE HAVE GOT OUR CHECKS HERE, GOING INTO RESEARCH. I THINK SOMETHING THAT IS NOT WELL REPRESENTED IN THIS SLIDE, I TAKE FULL RESPONSIBILITY FOR THAT IS THIS DATA IS ALSO KIND OF OUT AND ACCESSIBLE FOR CITIZEN SCIENCE. AND RESULT RESULTS COMING BACK IN. SO A STRONG REQUIREMENT AND KIND OF PRINCIPLE AND REACHERS WILL HAVE TO COME BACK INTO THE COHORT. WE WANT THOSE RESULTO BE PUBLICLY ACCESSIBLE, AND WE WANT DATA TO COME BACK OUT TO VOLUNTEERS AS THEY WISH TO RECEIVE IT. AND THE ANTICIPATION IS THAT THIS BEAUTIFUL CLOUD OF DATA CONTINUES TO GROW OVER TIME. SO JUST A FEW MORE THINGS, IN TERMS OF RETURN RESULTS AND DATA, ONE OF THE THINGS I JUSTER ELUDED TO, AND WE APPRECIATED VERY STRONGLY IN THE REPORT. PARTICIPANTS WILL HAVE PREACHES ABOUT WHAT THEY WANT TO GET BACK. KATHY HAS SAID, FRANCES IS THE DEPUTY DIRECTOR OF SCIENCE OUTREACH AND POLICY, WHO IS ONE OF THE COCHAIRS OF THE RESPECT SAID I DON'T WANT TO GET ANYTHING BACK. BUT SHE'S NOT LIKE OTHER PEOPLE. SO IT'S VERY IMPORTANT THAT WE HAVE PEOPLE BE ABLE TO CONTROL THEIR PREFERENCES FOR WHAT KIND OF INFORMATION THEY GET BACK. OR WHAT INFORMATION THEY WANT EXPOSURE TO. AND THEN IN TERMS OF PARTICIPANT ENGAGEMENT IN THE PMICOHORT PROGRAM. PARTICIPANTS MUST BE SUBSTANTIALLY REPRESENT ITCH AT ALL CONSTRUCTURES. SO THE GOVERNANCE AND THE DESIGN OF THE COHORT, IN THE CONTACT OF RATHER THAN, DR. WALL IS GOING TO BE TALKING MORE ABOUT THIS. DISSEMINATION, FOR EXAMPLE, THE IRB. DISSEMINATION OF RATHER THAN RESULTS, EVALUATION OF THE PROGRAM IN HELPING US MAKE SURE THAT WE'RE BUILDING THAT STRONG FOUNDATION OF TRUST SO THIS IS A CORE REQUIREMENT FOR HEALTHCARE PROVIDER ORGANIZATIONS, THEY SHARE OUR COMMITMENT TO PARTICIPATE ENGAGEMENT X THEY ENACT THAT COMMITMENT, IN REAL, AND ROBUST WAYS AND THE WORKING GROUP REPORT, ALSO HAD A BEAUTIFUL SECOND ON POLICY. AGAIN, THIS IS JUST TO GIVE YOU A HEADS UP THAT THIS WAS PART OF IT. DR. WELL IS GOING TO BE TALKING ABOUT T. SOME OF THE POLICIES THAT WERE RECOGN IS THE NEED TO DEAL PRODUCTIVELY WITH IRB. WITH PRIVACY AND SECURITY, WITH HOW WE GO ABOUT ENACKING THIS VERY AMBITIOUS APPROACH TO SHARING RESULTS AND PROVIDING ACCESS TO DATA AND HOW DO WE DO WITH SPECIAL POLICY SITUATIONS IN RETAINING CHILDREN, ENROLLING AND RETAINING PEOPLE WHO ARE DECISIONALLY IMPAIRED DURING THEIR PARTICIPATION IN THE COHORT, AS WELL AS PARTICIPANTS WHO MAY BECOME INCARCERATED. AND THEN THE FINAL PIECE, WAS THE GOVERNANCE STRUCTURE AND SO THE RECOMMENDATIONS ARE VERY CLOSE TO WHAT WE HAVE ENACTED HERE. SO WITH THAT, I AM GOING TO CLOSE MY SUMMARY OF KIND OF HOW WE GOT TO THE POINT OF SEPTEMBER 17 WHEN W E ISSUED THE WORKING GROUP REPORT AND ILL LIKE TOIN' SIGHT TH -- I WOULD LIKE TO INS IGHT, WELCOME FOLKS AROUND THE TABLE WHO WERE A PART THAT HAVE PROCESS, JOINT CONVERSATION AND GIVE THEIR REFLECTIONS. >> GWEN, THANK YOU, THAT WAS TERRIFIC. AND A VERY SPECIAL CONSULTATIVE PROCESS. A NUMBER OF YOU PARTICIPATED IN IT, A NUMBER MUCH YOU WERE PARTICIPANTS IN ONE MORE PIECE IT OF IT [PLEASE STAND BY] PUCKER PUSH THROUGH A SERIES OF WORKSHOPS, WE ALL LEARNED FROM EACH OTHER. AND WE MOVED THOSE JUST A LITTLE CLOSER TOGETHER. I THINK THAT'S A SPIRIT OF INNOVATION AND NOT FAILING IN A FAMILIAR WAY. EXPECTATIONS OF ENGAGEMENT. WILL PRIME OUR RESEARCH. SOMETHING IMPORTANT IS THE ABILITY TO RECONTACT GOING TO TOUCH,A THE NIH. IT'S GOING TO PREP AND PRIME RESEARCH IN THAT WAY. I THINK WE'RE REALLY GOING TO HAVE TO TOW THE LINE ON THAT. >> TERRIFIC. THANK YOU MUCH. ERIC DISHMAN. CAN YOU TELL US YOUR THOUGHTS FROM THIS CONSULTATIVE PROCESS OF THIS WORKING GROUP. >> SURE. >> I'LL HAVE TO SAY, I'VE MISSED DOING THIS I WILL SAY, ALL OF THIS SITTING AROUND THIS TABLE, AND SERVE ON LOTS OF DIFFERENT WORKING GROUPS AND EXIT COMMITTEES THAT GET SET UP. IT IS A WORKING GROUP, THIS IS NOT A -- YOU KNOW, IT WAS ARE THEY WRITATION GROUP PATIENT TOGETHER, YOU KNOW, PEOPLE ARE FINALLING CITATIONS FOR THE FINAL REPORT. AND IT'S HARD ENOUGH TO WRITE A DISSERTATION BY YOURSELF, BUT DOING IT WITH, PEOPLE, IT WAS BOTH INCREDIBLY ENERGIZING, AND CAN BE FRUSTRATING AS WELL. I LEARNED MORE DURING THAT PERIOD OF TIME THAN THE PREVIOUS 20 YEARS COMBINED. IT WAS A GREAT OPPORTUNITY TO LEARN ABOUT DISCIPLINES FROM OTHER. I'M NOT SURPRISEDLY, GIVEN THAT I COME FROM INTEL X WORKED IN THE TECHNOLOGY FOR 25 YEARS, I FOCUSED A LOT ON DATA TYPES AND THE KECK NOOLOGY INFRASTRUCTURE. ON THAT FRONT THERE WAS QUITE A BIT OF DEBATE ABOUT WHEN AND WHEN WE START TAKING SOME OF THESE, DATA TYPES THERE WERE PEOPLE IN THE RECOMMENDATIONS AND WORKING GROUP WHO WANTED TO FOCUS AND THERE WERE, PEOPLE THAT NO, IF WE TART FIRST WITH ANYTHING, IT OUT TO BE APPS AND DATA, THOSE ARE EASY TO GET OUT THERE QUICKLY COLLECT THE DATA, LET PEOPLE USE IT AND SEE IF THERE ARE CORRELATIONS AND PREDICTIVE AND INTERVENTIONAL CAPABILITY THAT IS REALLY MATTER. SO YOU'LL HEAR ME SAY A LOT. THEY'RE PROBABLY GOING TO GET ME A T-SHIRT. I USED TO SAY A LOT IN THE -IN-THE- MEETINGS. TECHNOLOGICALLY AND ENGAGEMENT, WE NEED TO ESCAPE TO WHERE THE PUC IS GOING. THIS IS DIFFICULT TO DO BUT WE HAVE TO BUILD AN ARCHITECTURE FOR THE PROGRAM, BOTH TECHNICALLY AND PROTOCOL WISE. ARCHITECT AND STEIN FOR THINGS WE CAN AND CAN'T ANTICIPATE AS WELL AS WE CAN, BUT ALSO BE VERY PRACTICAL AND GET STARTED STARTED WITH SPECIAL LOW-HAING FRUIT OTHER THAN VENTIONS AND TECHNOLOGIES AND SENSING AND DATA DEVICES WHERE WE CAN JUST START RIGHT OUT OF THE GATE. I LOOK FORWARD TO IT. I DON'T THINK WE HAVE TO WRITE A DISSERTATION THIS TIME, BUT I THINK IT'LL BE LOTS [INDISCERNIBLE] >> DON'T COUNT ON IT. WE HAVE SOME REAL WORK PRODUCTS ENVISIONED AHEAD. I HOPE TO USE ALL OF YOU TO GIVE US SOME VERY CONCRETE ADVICE ABOUT SOME OF THE PRACTICAL CHALLENGES AHEAD. >> OBVIOUSLY, I WANT TO REINFORCE THE MENS OF THE PREVIOUS SPEAKERS BUT ALSO, IT'S AMAZING HOW MUCH STILL HAS TO BE FIGURED OUT. DESPITE THE 110 PAGES AND HUNDREDS OF RECOMMEND EGGS, IT IS IMPRESSIVE. HOW MUCH WE LEFT UNDECIDED BECAUSE IT NEEDED TO BE. BECAUSE WE REALLY WANT THE PARTICIPANTS TO HELP US DECIDE, AND THE SCIENCE WILL HELP US DECIDE. SO I THINK BOTH THE ADVISORY PANEL AND THE EVENTUAL AWARDEES AND STEERING COMMITS HAVE A LOT MADE. THAT DOESN'T NECESSARILY COME ACROSS IN THE DETAILS OF THE 110 PAGES. AND THOSE IMPORTANT DECISIONS NEED TO BE MADE IN A WAY THAT ALLOWS US TO DO SOMETHING WHICH WE TYPICALLY DON'T DO. WHICH IS MAKE SMALL MISTAKES OFTEN. SO THAT WE MAKE BIG SUCCESSES. CELEBRATE THE MALL FAILURES SO IT ENABLES BIGGER SUCCESSES. I THINK WE WE NEED TO CREATE A CULTURE AFTERNOON THAT. AND THE WORKING GROUP TRIED TO DO THAT. AND WHAT'S THE RIGHT AWAY ON TO MAKE THAT BALANCE OF TINY MISTAKES BECAUSE THAT'S HOW WE MAKE BETTER SCIENCE. ONE IMPORTANT THING THAT CAME ACROSS IN THE CONVERSATIONS, AND THE WORKING GROUP ALSO MENTIONS, WE HAVE TO FOCUS ON MAKING SURE THE GOVERNMENT LEADS BY EXAMPLE HERE. THERE ARE A LOT OF THINGS REGARDING OPENNESS, DATA ACCESS. PARTICIPANT ENGAGEMENT, DIVERSITY AND HITTICALLY, WE HAVEN'T NECESSARILY LED BY EXAMPLES IN THOSE AREAS. WE HAVE GOT GOVERNMENTAL AGENCIES, THE CDC OR MEDICARE. THAT ARE VERY HARD TO GET DATA OUT OF. YET, WE'RE ASKING AWARDEES AND BE VERY OPEN WITH THE DATA YET, WE WON'T GIVE THEM DATA BACK. ONE OF THE THINGS TABLET BY EXAMPLE IS FOCUS ON EXECUTION AND PACE. ANNOUNCE AN RFP. AND HAVE IT REVIEWED A MONTH LATER. THE CONCEPT LEADING BY EXAMPLE WHEN, WE TOLL POTENTIAL APPLICANTS. YOU NEED TO MOVE FAST ON THIS. THAT'S GOING TO HAVE TO CONTINUE IN A LOT OF VERY SPECIFIC AREAS AND IT'LL BE UNCOMFORTABLE FOR THE GOVERNMENT AND THAT'S WONDERFUL. IT'LL BE UNCOMFORTABLE FOR ALL PARTICIPATES AS WELL JOHN, YOU ARE ALSO VERY MUCH PART OF THESE DELIBERATIONS. TELL US YOUR THOUGHTS AND BEING PART OF THE GOVERNMENT AND LEADING BY EXAMPLE TO BOTH YOU AND I. SO THERE ARE PROBABLY FOUR THINGS I'LL TRY TO TELL YOU BRIEFLY. THE FIRST IS THAT I REALLY, I CANNOT ON THE OTHER HAND SCORE ENOUGH, THE UNIQUE NATURE OF THIS INITIATIVE. YOU KNOW, I'VE BEEN IN GOVERNMENT FOREVER, FOR A -- EYE HAVEN'T BEEN IN GOVERNMENT PHOTOGRAPHER, BUT I'VE BEEN IN GOVERNMENT FOR A REASONABLY LONG TIME. THE EXCITEMENT AND ENTHUSIASM THAT I HAVE WITNESSED FROM NOT JUST MY COLLEAGUES FROM AROUND THE TABLE. BUT THE WHITE HOUSE BUT THE WHITE HOUSE AND CONGRESS, SPENT A A LOT OF TIME TALKING TO CONGRESS THIS PAST YEAR, AND THEY GET IT. PERIODIC. AND THAT'S A BIG DEAL IN WASHINGTON. SO IT IS UNIQUE OPPORTUNITY AND IT'S A REALLY EXCITING OPPORTUNITY. SO I'M GLAD YOU ARE HERE ON THE JOURNEY. I'VE SEEN A LOT OF REPORTINGS. IT'S A REALLY GOOD REPORT. SO THE FIRST IS THAT AS YOU SAW, LAID OUT IN ALL THE RECOMMEND EGGS, THE DEEP ROOTEDNESS OF DATA AND INFORMATION AND DATA SCIENCES THROUGHOUT ALL THIS, YOU KNOW, WE MAY HAVE BEEN STARTING TALKING ABOUT THE GENOME AND YEAH, 10, 11 YEARS AGO KIND OF STARTED WITH THIS BECAUSE THAT'S WHERE FRANCIS CAME FROM, BUT I THINK AS THINGS HAVE COME INTO BLOOP, THE PERVASIVE NATURE TELEVISION DATA AND QUANTIFIABLE DATA IN OUR LIVES NOW, AND THE RECOGNITION OF THE POWER AND PERIL OF THAT, AS WELL, I THINK THAT REFLECTS THE CHANGE THAT I'VE BEEN PART OF, TOO SEE CHANGE IN HEALTHCARE OVER THE PAST FIVE, SIX CAREERS, WHICH HAS BEEN THE DRAMATIC UPTICK, ACCELERATED BY AN INCENTIVE PROGRAM OF THE USE IN INFORMATION TECHNOLOGY. AS A FAMILY DOC. THAT WAS MY DEAL. OCCASIONALLY, I'D CUT SOMETHING OFF OF SOMEONE, OR INJECTED THEM WITH SOMETHING. SO THE -- THIS WAS THE SECOND THING. THE THIRD THING S I ALSO THINK IS REFLECTED IN THE RECOMMEND EGGS ARE MY BOSS, KAREN'S DEEP SEEDED TIRE THAT THIS NOT BE BUSINESS AS USUAL FOR RESEARCH AND IT MUST REFLECT DIVERSITY PARTICIPANTS. ACROSS THE NATION. -- AND COMPLEXITY, AND YOU KNOW, PEOPLE AT DIFFERENT PLACES IN THEIR LIVES. CAN'T JUST HELP, YOU KNOW THE REALLY BRIGHT ACCIDENT TALENTED PEOPLE. WE HAVE GOT TO HELP EVERYBODY WITH THIS SO I THINK THIS IS WELL REFLECTED, AND I KNOW KAREN AND I WILL WANT TO SEE THAT DRIVE FORWARD. THIS IS A STORY FROM HOME, SO MY WIFE AND I, HOME SCHOOL OUR THREE KIDS AND I AM THE DESIGNATED SCIENCE TEACHER AND MY DAUGHTER IS A FRESHMAN IN HIGH SCHOOL, AND WE HAVE BEEN DOING BIOLOGY THIS SEMESTER, LITERALLY, THE PAST COUPLE OF DAYS, FIRST OF ALL, I'VE GOT TO THANK MY COLLEAGUES HERE AT NIH. YOU GUYS CRUST MAKE SO MUCH MORE SENSE IN COLLEGE THAN IT DOES NOW. THANK YOU. BUT SECOND, YOU KNOW, I STARTED LIFE AS A FAMILY DOCTOR, AND I BECAME A BUREAUCRAT, AND THE AND I DO WHAT I DO TO HELP OTHER DOCTORS TAKE CARE OF PEOPLE WITH THEIR OTHER INFORMATION SYSTEMS BUT AS WE WERE TALKING ABOUT PRECISION MEDICINE STUFF OVER THE PAST YEAR AND AB GAL GOT F. SHE'S LIKE OH. ALL THIS GENOMIC INFORMATION ABOUT US, THIS IS PART OF WHO WE ARE AND HELPS US UNDERSTAND WHAT KEEPS IT HEALTHY OR NOT: THAT WAS HER WORDS. I'M LIKE, YEAH. THAT'S T. I KNOW ALL OF US AROUND THE ROOM ARE DRIVEN BY THE FOLKS IN OUR LIVES THAT ARE AFFECTED BY THIS STUFF. THIS IS SOMETHING WE'RE NOT DOING JUST FOR US HERE AND THE NEXT COUPLE OF YEARS. THIS IS FOR DECADES TO COME. SO IT'S GOOD WORK. LET'S GET TO IT. THANKS. SHARON, YOU PARTICIPATED I ECHO A LOT OF THE COMMENTS WE HEARD, AND REALLY APPRECIATE YOUR SUMMARY. I WAS IMPRESSED WITH BOTH THE PROCESS, AND THE SENSE IT WAS TRULY A GOOD OUTREACH TO LOTS OF COMMUNITIES WE HEARD FROM PEOPLE WE DON'T NORMALLY HEAR FROM. I MEANINGFUL PARTICIPATE, AND NOT JUST BECAUSE I'VE MATURED BUT I THINK NIH HAS MATURED AND A LOT OF THINGS THAT I THINK ARE IMPORTANT, THE ONE THING I WILL SAY IS I'M REALLY INTERESTED IN HELPING AND BEING PART OF DOING SOMETHING IN A DIFFERENT WAY. AND THAT IS, I THINK WE HAVE SEEN HELP COME FROM THE TECHNOLOGY SECTOR, OUT OF SILICON VALLEY, NEGLECTED THE FACT THAT WE ARE IN A SYSTEM THAT ONE COULD CALL, AS I SAID EARLY EARTHS COTTAGE 43 OR A VERY HIGHLY REGULATED COMPLEX INDUSTRY. IT'S BOTH AND I THINK THOSE 4 WAYS FROM SILICONE VALLEY HAVE THE HEALTH PIECE DOWN AS WELL AS THEY SHOULD. LIVING INSIDE THE BELTWAY, AND, WONDERING HERE ALL THESE YEARS, I THINK WE I THINK WE ARE SO ENTRENCHED IN TRADITIONAL MODELS THAT ARE EGG BOGGED DOWN, IT'S ASTOUNDING AND SUPER ASTOUNDING TO THE PUBLIC AND IT WAS TO ME, EVEN WHEN MY KIDS WERE DIAGNOSED AND THERE WAS NO REGULARD TO EP PATH TO GET TO A SOLUTION. 20 YEARS LATER, THERE'S STILL NOT. I THINK THE TENSION FOR US IS HOW DO WE DO THESE INSIDE THE WALLS. WE HAVE A DIRECT DIRECTOR THAT HAS VISION AND PASSION ACTING DIRECTOR AND CODIRECT ARES ON THAT ARE ALSO FILLED WITH PASSION, BUT WE'RE INSIDE A SYSTEM THAT IS REALLY BOGGED DOWN. SO HOW CAN WE NOT BE SUCKED INTO THE TRADITIONAL PATHWAYS AND EVEN THE REVIEWS FOR THESE VARIOUS PROPOSALS THAT WILL BE COMING IN, IN THE NEXT WAVE, AND HOW CAN WE NOT BE SO DISCONNECT FRIDAY HEALTH, AND ENAMORED WITH THE WIDGETS AND TECHNOLOGIES WE SEE PASSION THAT IS DO TAKE OVER THOSE TREES, WE HAVEN'T SEEN THAT EASY CONNECTION IN HEALTH BECAUSE CONSUMERS ARE SO DISCONNECTED AND NATIONAL POTENTIALLY BRINGS TO PLAYS WHERE WE ARE CONNECTED AND I WANT TO WORK TOWARDS THAT AND HELP US TO REMEMBER THAT AS WE MOVE FORWARD. >> THANK YOU. PEOPLE WHO WERE NOT PARTICIPANTS IN THIS PROCESS, HAVE QUESTIONS ABOUT THE DO YOU HAVE QUESTIONS ABOUT THIS FIRST STAGE? MAKE SURE WE'RE ALL ON THE SAME PAGE. SO I WONDERED IF YOU HAD COMMENTS OR QUESTIONS ON WHAT YOU'VE HEARD SO FAR. I REALLY COMMENT THE GROUP FOR PULLING THAT TOGETHER. AND I THINK IT'S MUCH MORE THAN HAVING BEEN ABLE TO, WHAT I READ FROM T BEEN ABLE TO ASSEMBLE DIFFERENT VIEWPOINTS. IT'S NEARLY RIGID OR COMES DOWN TO A WATERED DOWN VERSION OF COMPROMISE. I THINK IT CAPTURES THE VISION FOR A FUTURE THAT DOESN'T EXIST TODAY AND ENABLES A LOT OF FLEXIBILITY. IT COULDN'T OF COURSE EASY, NOT JUST IN THE RIGHTING AND THE PRACTICAL PART, BUT IN GETTING PROBABLY VERY DESPERATE VIEWPOINTINGS AROUND THAT TABLE. >> I REALLY WANT TO ECHO THIS POINT. AFTER BEING PART OF MANY STRATEGIC PLANNING EFFORTS, MANY OF SUCH DOCUMENTS END UP BEING A AND B THE AMBIG IS HUGE. WE HAVE A LOT LEFT TO DO BUT IT WAS A TERRIFIC ACCOMPLISHMENT. I CAN'T SEEM TO FIND IT THROUGH AND YOU HAD IT IN YOUR SLIDE. WHY IS CANTSER SPLIT OUT IF IT'S ALL AGES ALL DISEASES WHY DO WE ALWAYS DO THAT >> >> SO LET ME TRY AND GWEN CAN AMPLIFY THAT IN TERMS OF USING GENOMIC TOOLS TO TARGET AND DEVELOP THERAPIES, THERE ARE CANCER ACTIVITIES THAT ARE AHEAD OF MOST, DISEASES AND SO WE DO HAVE A NUMBER OF PLACES WHERE THERAPEUTIC ALTERNATIVES, DRIVEN BY JEN EXPRESSION IN THE TUMOR IS STARTING TO COME TOGETHER. AND SO THAT REALLY SEEMED BY ITSELF, MATURE ENOUGH FOR ESSENTIAL ADDITIONAL INVESTMENT. IT'S SORT OF LIKE THAT BLOCK IS ALREADY HERE. LET'S KEEP IT MOVING AND BUT THE COHORT PROGRAM THAT WE'RE TALKING ABOUT TOGETHER. SO THERE'S NO INTENTION THAT THE WORK WE TALK ABOUT THAT YOU THIS MILLION PERSON PROGRAM CAN'T LOOK AT SUSCEPTIBILITY CANCER OR DIAGNOSTICS FOR CANCER OR EARLY TREATMENT ISSUES BUT REALLY, THE INTENT OF THE 70 MILLION NCIINVESTMENT IS TO REALLY BUILD ON THE PROGRAMSING LEADS FOR THERAPEUTIC DEVELOPMENT, THAT ARE ALREADY READY TO BE ACTIONABLE. SO THESE ARE PARALLEL, BUT ONE IS TAKING A PART OF THE PROCESS A BIT MORE MATURE >> SO IT'S HELPFUL TO HEAR THAT RESPONSE BECAUSE THAT MAKES SENSE. I THINK IT'S HARD TO ARGUE THAT CANCER IS NOT AHEAD FOR REASONS YOU DESCRIBED. THE CONCERN WAS, IT'S FUNNED AND DEALT WITH SEPARATELY, THEN THE REST OF THE DISEASES DON'T GET TO LEARN FROM THOSE LESSONS OF CANCER >> AND I THINK WE HAVE TO COLLECTIVELY MAKE SURE THAT WE ARE LEARNING FROM EVERYTHING THAT'S HAPPENING THERE. BUT NO ONE HAS THOUGHT THAT CANCER APPLICATIONS OF THE MILLION PERSON COHORT ARE NOT GOING TO BE PART OF THE AGENDA, SO JUST TO CLARIFY THAT. LET ME KEEP GOING TO HEAR FROM EACH ARE YOU -- WE'RE HEARING SOMEONE ON THE PHONE. WHO IS THAT? >> I'M GOING TO TRY TO JUST LISTEN IN, WHILE I'M IN TRANSIT AND LOOK FORWARD TO SEEING YOU GUY THIS IS AFTERNOON. JUST TO REITERATE WHAT YOU SAID IN THE WORKING GROUP, INS DIDN'T CANCER IS GOING TO BE AN IMPORTANT PART OF THE MILLION PERSON COHORT. SO IT WILL BE COMPLEMENTARY THROUGHOUT PRECISION ONCOLOGY COMPONENT. FROM THIS POINT ON WHILE I'M IN FRANCEITY I'M GOING TO LISTEN QUIETLY WITH THE PHONE ON MUTE. >> WE WELCOME YOUR PRESENCE, AS SOON AS CAN YOU PHYSICALLY BE HERE IN THE ROOM WITH US MANY OF YOU KNOW, MIKE IS ONE OF THE KEY LEADERS OF THE MILLIONS VETS PROGRAM, A PROGRAM WE EXPECT TO WORK VERY HARD TO ACTIVELY INTEGRATE WITH WHAT WE'RE CREATING HERE. SO I WANT TO HEAR FROM OUR OTHER ADVISORY PANEL MEMBERS FROM QUESTIONS THAT HAVE COME UP FROM WHAT YOU HEARD SO FAR. I REALLY DON'T HAVE ANY QUESTIONS, OTHER THAN, YOU KNOW, LOOKING AT THE CORE VALUES AND REALIZING THAT IT'S REALLY A TALL HURDLE. , I GUESS IF I HAD TO LAND ON ONE THING Q. YOU THINK ABOUT THIS BEING A LONGITUDINAL STUDY I THINK OF HOW FAR DIFFICULT IT IS TO TRACK PEOPLE IN UNDER REPRESENTED COMMUNITIES. I THINK OF THAT IN MY DAYS FROM BELL VIEW AND WE'LL HAVE TO BE REAL CRAFTY ABOUT HOW WE MAKE THAT HAPPEN >> TOTALLY AGREE. THANK YOU. IMPORTANT POINT. >> I'M IMPRESSED BY OVER ALL VISION AND SCOPE OF THE PROJECT, AND IT WOULD BE HELPFUL TO GET A COPY OF THE POWERPOINT SLIDES. THERE WAS A -- WE HAVE MADE A DECISION, AND WE NEED TO REALIZE THE SIGNIFICANT IMPLICATIONS OF THE DECISION. THE DECISION NOT TO PURSUE NATIONAL REPRESENTATIVE SAMPLE. THE SAMPLE IS REALLY ACHIEVABLE. IT'S ABSOLUTE AND ACCURATE. THERE ARE LARGE FEDERAL SURVEY THAT IS DO NATIONAL REPPIVE SAMPLES. THERE'S THE AMERICAN -- >> LET ME EXPLAIN THAT >> LET ME JUST FINISH. AMERICAN COMMUNITY SURVEY THAT SAMPLE 700,000 -- EYE JUST LOOKED IT UP. A RESPONSE RATE OF 96 PASSPORT 7%. SO IT CAN BE DONE AND IT IS EXPENSIVE. IT'LL DEFINITELY COST MORE, AND I THINK WE DO NOT HAVE UNLIMITED RESOURCES AND WE MAY DECIDE, WE CANNOT POSSIBLY AFFORD IT. THAT'S THE REAL WORLD AND THAT'S FINE. BUT I THINK WE SHOULD SAY THAT BUT RECOGNIZE THAT THE GOAL OF ACHIEVING THE DIVERSITY THAT YOU WANT IS GOING TO BE GREATLY COMPROMISED BY NOT USING THE REPRESENTATIVE STRATEGY. WHAT I MEAN BY THAT. OF COURSE YOU COULD GET CLINICS INVOLVED AND NUMBERS BUT WHAT YOU WANT TO DO IS TO GET NUMBERS THAT ARE REPRESENTATIVE OF A LARGER GROUP SO THAT YOU KNOW THAT YOU DIDN'T JUST GET SOME NATIVE HAWAIIANCE HERE AND? NATIVE-AMERICAN HERE AND AFRICAN-AMERICANS THERE BUT YOU HAVE A SAMPLE THAT IS REPRESENTATIVE OF THE POPULATION SO THAT YOU CAN IN FACT, MAKE STATEMENTS THAT ARE TRUE OF THE ENTIRE POPULATION. IT'S A HUGE PROBLEM IN A LOT OF MEDICAL RESEARCH CURRENTLY, WHERE WE USE AD HOC SAMPLES AND GENERALIZE ALL POPULATION GROUPS IN OTHER AREAS OF SCIENCE, THAT WOULD BE REGARDED AS MALPRACTICE. NO SAMPLE STATISTICIANS IS GOING TO GENERALIZE FROM AN AD HOC GROUP IN THE CORNER, TOO SAY WHAT PERCENTAGE OF THE AMERICANS THAT SUPPORT AN EXCANDIDATE AND WHY. YOU WANT TO HAVE A REPRESENTATIVE SAMPLE. WE NEED TO DEVOTE EXPLICIT ATTENTION. HOW DO WE ENSURE WE GET RANGE OF DIVERSITY WITHIN POPULATION THAT IS WE WANT. LET ME TRY, AND OTHER CONSIST ADD TO THIS. GIVE YOU SOME BACKGROUND ON HOW THIS DECISION WAS MADE. THE NIH AND CDC INVEST PRETTY HEAVILY IN PROCESSES TO GET POPULATION SAMPLES. OUR SMALL CENTER PUTS ABOUT 3-$5 MILLION A YEAR, ON THE USE OF COMPLEMENTARY AND INTEGRATIVE HEALTH. AND I HAVE FOR A NUMBER OF YEARS YEARS, SEEN ACTIVITY I PHILLY UNDERSTAND THE INCREDIBLE IMPORTANCE OF DATA SETS THAT TRULY ALLOW YOU TO MAKE CONCHEWINGS ABOUT THE ENTIRE POPULATION. EXPECTATION THAT IS WE BE ABLE TO COMPARE THE DEMOGRAPHICS, TOO SET STANDARDS FOR THE DEMOGRAPHICS, THAT CAN BE A BENCH MARKED AGAINST OUR LARGE INVESTMENT IN OUR REPRESENTATIVE SAMPLES. ONE OF THE THINGS THAT WAS IN THE BACKGROUND WAS WERE THE INCREDIBLE CROSSOVER RUNS IN THE DEVELOPMENT. THE REAL FAILURE OF EFFECTIVE CREATION OF A REPRESENTATIVE SAMPLE, AND THAT WAS INDEED, PART OF I THINK YET WORKING GROUP CAME DOWN WITH THIS ALTERNATE STRATEGY. BUT BUT I FULLY UNDERSTAND THE POINT YOU'RE MAKING AND I THINK ONE OF THE THINGS YOU WILL HAVE TO INTERJECT INTO OUR CONFERREDS WITH IRREGULATED LAYERITY, IS EXACTLY THAT MONTH. HOW DO WE THINK ABOUT THE SAMPLE WE HAVE CREATED AND WHAT ARE THE METRICS TO SAY, WE HAVE PULLED A SUBSET, WE CREATED A SUBSET THAT ALLOWS EXTRAPOLATION BEYOND TO A POPULATION SAMPLE. IF YOU'RE A GEOGRAALLY REPRESENTATIVE, THAT MEANS MORE PEOPLE IN CALIFORNIA SHOULD BE IN A COHORT. WE SPECIFICALLY DONE THE CHOOSE THAT WORD, PARTLY BECAUSE IT MAY RESULT IN PEOPLE INTERPRETING IT TO, THINGS OTHER THAN WHAT'S INTENDED BY THAT A BIOSAMPLE AND COHORT THAT WAS AS NONREPRESENTATIVE AS WE HAD TODAY, IT WOULD ABE COMPLETE AND TOTAL FAILURE AND THAT HOPEFULLY, CAME ACROSS VERY CLEARLY IT BECAME A MATHEMATICAL CONCEPT AND WE DIDN'T WANT MATH MATHEMATICAL CONCEPTS THAT CAN BE BIAS IN OTHER WAYS BY GEOGRAPHY OR OTHER THINGS TO GO TO THIS. THIS IS ONE OF THE AREAS WE LEFT IT A LITTLE BIT VAGUE, BUT CARITY CLEARLY, WE CAN'T KEEP DOING WHAT WE'RE DOING. THAT WOULD BE A FAILURE. A MAJOR ACTIVITY IN THE COMMUNICATION PILOT, IT IS KNOWN THAT UNDER SERVED POPULATIONS, TYPICALLY ARE UNDER SERVED BY OUR RATHER THAN PROCESSES. SO THE INTENT HERE HAS BEEN TO DEVELOP STRATEGIES THAT WILL -- THAT WILL OVER RECRUIT IN POPULATIONS THAT WE KNOW, IF WE LET THIS UNUNIMPEDED, WE WILL HAVE A SKEWING IN THE OPPOSITE DIRECT. THIS IS AN INCREDIBLY CRITICAL ISSUE, AND ONE THAT WILL BE A CONSTANT TENACIN, OR SUBJECT FOR METRICS AND MEASUREMENT AS WE MOVE FORWARD. I WANTED TO BRING UP TWO, WHAT I SEE AS POTENTIAY IMPORTANT OPPORTUNITIES, AND TELL ME IF THESE VERGE OVER TO THE TERRITORY THAT BELONG IN THE CLOSED SESSION. ONE HAS TO DO WITH AN ENGAGING WITH HEALTHCARE SYSTEMS REGARDING PATIENT-REPORTED OUT COMES AND OTHER STANDARDIZED MEASUREMENTS TO ME. IF WE WERE ABLE TO SUCCESSFULLY ENGAGE WITH LARGE HEALTHCARE SYSTEMS ABOUT HARMONIZATION OF MEASUREMENT, YOU KNOW, WE'VE BEEN ABLE TO DO THAT IN A SMALL MENTAL HEALTH NETWORK RESEARCH. SITDOWN WITH MEDICAL DIRECTORS OF LARGE HEALTHCARE SYSTEMS ABOUT SYSTEMATIC OUTCOME ASSESSMENTS PEOPLE RECEIVING MENTAL HEALTH CARE X WHAT IT'S RESULTED IN, AT NO COST TO THE GOVERNMENT. A DATA RESOURCE NOW COVERS SEVERAL HUNDREDS OF THANS OF PEOPLE. AND SEQUENTIAL OPERATIONS AND RECORDED IN THE HR. THE KEY TO OF THE REALIZING, AS I TRY TO REMIND MYSELF EVERY DAY. WE ARE JUST THE TAIL. WE ARE NOT THE DOG. AND SITTING IN A ROOM WITH PEOPLE WHO RUN LARGE HEALTHCARE SYSTEMS AND REALIZING, REMINISCEN OF THE AUSTIN POWERS MOVIE, WE'RE SITTING THERE, THINKING WE HAVE A RESEARCH GRANT OF $1 MILLION. WHEN YOU REALIZE THE COMBINED ANNUAL EXPENDITURES OF THE PEOPLE SITTING AROUND THIS TABLE. WERE 95 BILLION. SO CLEARLY, THEY ARE NOT FIGURE -- CLEARLY, THEY ARE NOT GOING TO FOLLOW OUR AGENDA, BUT I THINK THE POINT THAT THERE IS A CONVENING FUNCTION, AN EXPORTING AND INSPIRING FUNCTION TO GET HEALTHCARE SYSTEMS ON BOARD WHAT WE'RE TALKING ABOUT REALLY, IS THE TRANSFORMATION OF AMERICAN HEALTHCARE INTO SYSTEMATIC HEALTHCARE ASSESSMENT. IF WE HAVE MUCH MORE DETAILED INFORMATION ON A DEFINED COHORT, WE'RE ABLE TO EMBED THAT IN PLAYS WHERE R IT CAME FROM I HAVE A SECOND ONE, BUT THAT'S ONE OF MY CAMPAIGN SPEECHES IF YOU LOOK AT MACRO LEGISLATION, RECENTLY PASSED FOR ALL NET CARE PROVIDERS THEY HAVE TO USE CERTIFY HEALTH PROVIDERS TO PARTICIPATE IN THE INCENTIVE. USE CERTIFIED HEALTH I.T. FOR THAT. SO I THINK WE ARE KEENLY INTERESTED IN BEING PART OF THE CONVERSATION AND AS STANDARDIZATION, EITHER OF DATA OR HOW YOU HANDLE DATA, APPROACH DATA, HOW YOU DEAL WITH PRIVACY POLICIES AND THINGS LIKE THAT. THAT GETS INCORPORATED INTO THE BROADER DELIVERY SYSTEM REFORM EFFORTS THAT ARE, YOU KNOW, HEALTHCARE AND DRIVING, HOPEFULLY, TOO A BETTER PLACE. I'M EAGER TO HEAR YOUR SECOND COMMENT. THE WAY IF HAS -- THE VOICES ACROSS THE FEDERAL GOVERNMENT EFFECTIVELY USE TO USE FOR FEDERAL POLICIES THAT IMPACT ON THE IMPLEMENTATIO IMPLEMENTATION -- KAREN -- YOU'RE GOING TO HEAR FROM HER MORE THIS AFTERNOON, BUT I THOUGHT SHE MAY HAVE SOME COMMENTS AT THIS STAGE IN THE CONVERSATION. BUT YOU HAD A SECOND POINT. >> SURE. THE SECOND POINT OR SUGGESTION OR POSSIBLY QUESTION, RELATES TO THE SORT OF RETURN OF RESULTS TO PARTICIPANTS. I WONDERED IF IT WAS ON THE TABLE AND I HOPED WE COULD PUT ON THE TABLE FOR PARTICIPANTS TO KNOW, WHO HAS TOUCHED MY INFORMATION AND WHAT HAVE THEY USED IT FOR. WHATY WE TALKED TO PEOPLE WITH MENTAL HEALTH CONSCIENCE, ABOUT USE OF ELECTRONIC RATHER THAN, THIS IS A PRIORITY, AND ONE OF THE, I THINK SOMETIMES ONE OF THE MISTAKES WE HAVE MADE WHEN WE TALK ABOUT PEOPLE'S USE OF HEALTH INFORMATION. WE SAID RESEARCHERS DESERVE PRIVACY OF THE PATIENTS THAT LIVE WITH THESE HEALTH CONDITIONS, THAT IT SHOULD BE AN OPEN BOOK. WE KNEW WE NEEDED A ONE WAY MIRROR. WE JUST INSTALL TODAY IN THE WRONG DIRECTION. AND IF WE WERE TO TURN THAT MIRROR AN. IT WOULD CHANGE THE CULTURE OF RESEARCHERS. THE QUESTIONS I ASK, I SHOULD BE ABLE TO ASK AND THINK ABOUT IN PRIVATE AND NO ONE SHOULD KNOW ABOUT, UNTIL I AM GOOD AND READY TO TELL THEM. MY OWN VIEW, I GET ON A SOAPBOX ABOUT THAT, THAT IS A BIG PROBLEM. BUT IT COULD BE REALLY TRANSFORMATIONAL, PEOPLE THAT CONTRIBUTE THEIR INFORMATION TO HEALTH RESEARCH, SHOULD KNOW HOW IT SHOULD BE USED AND IDEALLY, KNOW THAT IN A PRETTY TIMELY WAY. THIS IS A TOPIC WE WILL BE DISCUSSING IN ITS MANY NUANCES AND PROCESS IT AT MANY STAGES AS THIS MOVES FORWARD. AND I'M DELIGHTED TO HAVE YOUR EXPERTISE AND THOUGHTS ON THIS ONE. TWO OTHER PEOPLE, WE HAD ACTIVE PARTICIPATION FROM BOTH OUR OFFICE OF SCIENCE POLICY, NOW HEADED BY CARRIE AND FROM OUR BEHAVIORAL SCIENCE RESEARCH TEAM LED BY BILL REILLY, SO I WANTED TO HEAR THEIR PERSPECTIVES ON THE PLANNING STEPS THAT WE'RE GOING TO HEAR MORE FROM THEM LATER AS IT GOES FORWARD. CARRIE, WHAT DID YOU WANT TO ADD AT THIS POINT? >> I'LL TALK A LITTLE BIT MORE IN DEPTH LATER THIS AFTERNOON. BUT I THINK THE WORKING GROUP REPORT HAS AN ENTIRE CHAPTER ON CHAPTER 7. AND EMBEDDED THROUGHOUT, THERE ARE A LOT OF SORT OF RELATED TO POLICY RECOMMENDATIONS AND DISCUSSIONS THERE'S KIND OF THE BIG P POLICY STUFF, THAT INVOLVES COORDINATION WITH OTHER COORDINATION WITH OTHER AGENCIES, CHANGES THE STATUTE IT IS, LAWS, REGULATIONS, THINKING ABOUT HARMONIZATION ACROSS AGENCIES AND SOME OF THIS WERE DRECKS THAT ARE VERY MUCH THE BRED AND BUTTER OF WHERE NIH IS MOVING ANY I AWAY, BUT I THINK THE PMIAND THE COHORT PROGRAM HAS LENT A NEW SENSE OF URGENCY TO MOVING SOME OF THESE FORWARD AND SO OF COURSE SPENDING A LOT OF TIME COORDINATING ACROSS THE FEDERAL GOVERNMENT, AS JOSE MENTIONED, THEN THERE ARE THE SORT OF LITTLE P QUALITY QUESTIONS THAT ARE EMBEDDED IN THAT CHAPTER AND SORT OF THROUGHOUT THE REPORT, AND WHICH AROSE IN CONVERSATIONS, OVER AND OVER AGAIN, AS WE HELD WORKSHOPS AND DISCUSSED THE SORT OF VISION FOR PMI, EVERYBODY FROM CONSENTS TO RETURN OF RESULTS TO ACCESS TO DATA AND UNDERLYING THAT AND I'LL TALK MORE ABOUT IT THIS AFTERNOON, IS THAT FOUNDATION OF HEARING FROM PARTICIPANTS IN THE COHORT PROGRAM, AND AS WE SHAPE THOSE POLICIES AND MAKE DECISIONS AND HOW DO WE MAKE SURE THAT WE REALLY ARE ENGAGING AND HEARING FROM PARTICIPANTS IN A MEANINGFUL WAY WHAT THEIR POLICIES -- NOT JUST SORT OF WE HAVE CHECKED THE BOX OF THE PUBLIC COMMENT PERIOD. AND THAT IS A REALLY INTERESTING CHALLENGE THAT WE'RE SPENDING A LOT OF TIME THINKING ABOUT. AND I THINK, YOU KNOW, ARISES FROM THE FOUNDATION, PLANNING PROCESS AND WORKING GROUP REPORT, AND WE'RE TRYING TO TAKE THE SORT OF NEXT LEVEL IN OUR LOOKING FOR ALL OF YOU FOR A HELP LIST. >> THANK YOU, CARRIE. THE PERSON WHO I'M GOING TO TURN TO FOR LOTS OF ASPECTS OF THE BEHAVIORAL SCIENCE AND AND DEVICE-RELATED PARTS OF THIS PROJECT, IS MYISH RIM DEPUTY, BILL REILLY AND BILL WAS VERY MUCH A PART OF THE WORKING GROUP DELIBERATIONS ON THIS ASPECT OF IT. SO BILL, I WANTED YOU TO COMMENT ON WHAT YOU TOOK OUT OF THAT WHOLE DELIBERATIVE PROCESS. >> COUNTRY, SO THANK YOU, JOSE. I THINK FROM OUR PERSPECTIVE, WE'RE VERY EXCITED ABOUT THE 80 TO INFUSE BEHAVIORAL AND ENVIRONMENTAL RISK FACTORS VERY STRONGLY INTO THIS PROCESS, AND UNDERSTAND ALL THE VARIOUS SORT OF INFLUENCES OF HEALTH AND TO USE TECHNOLOGY IN WAYS WE HAVE NEVER USED BEFORE. I THINK ONE OF THE FACTORS FOR US OVER MANY YEARS HAS BEEN MOST OF WHAT WE'VE BEEN ABLE TO DO IN UNDERSTANDING BEHAVIORAL AND ENVIRONMENTAL RISK FACTORS HAS COME FROM SELF-REPORT. WE'LL STILL BE DOING A FAIR AMOUNT OF THE WORK. BUT THE TECHNOLOGY ALLOWS US TO DO THINGS IN WAYS WE PREVIOUSLY WERE INN ABLE TO DO. IN TERMS OF MEASURING BEHAVIORAL AND ENVIRONMENTAL INFLUENCES. AT ENVIRONMENTAL LEVEL, NEIGHBORHOOD LEVEL, POVERTY LEVEL. ALL OF THOSE SORTS OF THINGS, AS WELL HOW THEY BEHAVE IN DAY-TO-DAY SITUATIONS. DIET, PHYSICAL ACTIVITY, SMOKING. SO WE'RE EXCITED ABOUT THAT. THE SHIED THAT GWEN SHED ON M HEALTH, STARTED A MILLION IN 2004 -- [INDISCERNIBLE] IN 2004, YOU PROBABLY WOULDN'T RECOGNIZE WHAT THOSE WERE AS SMART PHONES. TECHNICALLY, THEY WERE. BUT THE IPHONE DIDN'T ACTUALLY COME ABOUT IN 2007. AND IN 14, THERE'S 58% PENETRATION. INER YEAH, WE'RE AT 68% PENETRATION IN SMART PHONE USE. SO ALL OF THOSE TECHNOLOGIES ARE BEING USED MUCH MORE RAPIDLY. WE WANT TO TAKE ADVANTAGE THE SMART PHONE PLATFORM, AND THE TECHNOLOGIES THAT CAN COME ALONG WITH THEM, TO BE ABLE TO MONITOR BEHAVIOR, DENSELY AND BE ABLE TO GET A BETTER UNDERSTANDING OF HOW THESE CHANGES OCCUR OVER TIME. SO WE'RE EXCITED ABOUT THAT PIECE OF IT. AND THAT CERTAINLY WAS AN EXCITING PART OF WHAT THE ACD WORKED ON AND THE FOCUS THEY HAD ON THOSE TECHNOLOGIES. , I GUESS THE LAST THING I'LL MENTION, JUST BECAUSE IT'S A STRUGGLE FOR US, ARE THESE THINGS VALIDATED OR ADEQUATELY TESTED IN RESEARCH POPULATIONS AND YOU'LL SEE IN THE FIELD RIGHT NOW, WHAT I THINK IS A REAL DISCORDANCE BETWEEN WHAT RESEARCHERS USE AND RATHER THAN-TRADE LEVELS OF TECHNOLOGY AND WHAT'S OUT IN THE COMMERCIAL SECTOR. IN SMOKING SENSATION, THERE'S ALREADY COCHRAN REVIEWS TO SHOW TEXT MESSAGES IS A VALID, REASONABLE EFFECTIVE WAY TO DO SMOKING SENSATION. STUDIES HAVE SEWN THAT, INCLUDING LARGE-SCALE CLINICAL TRIALS ON THAT. WHAT YOU WON'T SEE IF YOU GO OUT IN THE COMMERCIAL SECONDER, MOST AREN'T EMPEERICALLY BASED, MOST AREN'T CLEARLY SORT OF VALIDATED SO THERE'S A DISCONNECT BETWEEN WHAT WE CAN USE IN THE RESEARCH WORLD, AND WHAT WE USE OUT IN THE COMMERCIAL WORLD CAFE AND WE HAVE TO FIND SOME I AWAYS AND THIS WILL PROBABLY BE ONE OF THE EXCITING WAYS TO BETTER VALIDATE THINGS THAT ARE OUT THERE. BEING MORE READILY USED BY THE GENERAL POPULATION MCKEOWN COMMUNITY. SO I'LL STOP THERE >> ANY OTHER QUESTIONS FOR PEOPLE WHO PARTICIPATED IN THIS LAUNCHING ADVISORY PROCESS ABOUT THE ADVICE WE GOT AT THAT STAPLE. YOU'RE GOING TO HEAR, RIGHT AFTER OUR BREAK FROM ME, WHAT WE GOT STARTED WHAT I CALL PERFORMANCE MEASURES AND PSYCHOLOGICAL PERFORMS MEASURES. IN TERMS OF PERSONAL SITUATION AND MENTAL HEALTH TREATMENT, WE'RE PROBABLY A LOT CLOSER TO USING BIAS PROCESS OF EMOTION-RELATED INFORMATION OR EXECUTIVE FUNCTION MEASURES AND CERTAINLY, ANY OF THESE, THEY'RE DEPLOYABLE RIGHT NOW. I HAVE SOME OF THEM ON MY PHONE. SO THE TECHNOLOGY PART IS NOT HARD. BUT I DIDN'T SEE THE SORT OF, I SAW THE SELF-REPORT MEASURES, SOCIAL ENVIRONMENT AND BEHAVIORAL MEASURES BUT I THINK THIS IN-BETWEEN CATEGORY OF INTENTIONAL PERFORMS MEASURES THAT'S REALLY IMPORTANT. THESE PERFORMANCE MEASURES, ESPECIALLY ON COGNITIVE PERFORMANCE, AND THOSE ARE GETTING TO THE POINT, WHERE MORE AND MORE ARE ON THESE MOBILE PLATFORMS, AS OPPOSED TO LAPTOPS. >> YOU KNOW, I HAVE A COMMENT, I WANT TO JUST TAKE US BACK AND SAY, THERE'S ONE THING THAT IS GOING TO BE KEY, AND I THINK WE'LL LIVE WITH THIS ADVISORY PANEL IS THE TRAP BETWEEN GOING FOR THE QUICK WINS, AND THE EARLY SUCCESSES AND HOLDING US BELIEVABLE FOR THE VISION I COME FROM A BACKGROUND OF HUMAN SOURCES, I DIDN'T GET INTO, BUT IT IS HARDER AND MORE EXPENSIVE TO GO AND ENGAGE UNDER REPRESENTED POPULATIONS AND REACH PEOPLE THAT HAVEN'T BEEN THING FROMMAL USUAL SUSPECTS AND RESEARCH I FIND THE PRESIDENT'S INTEREST IN THIS BELIEVES ME TO BELIEVE THERE'S GOING TO BE PRESSURE TO PRODUCE SOMETHING BY THE END OF THE YEAR, AND BEING AGO AT YEARS 3-5 AND 5-10, I THINK THIS GROUP IS REALLY GOING TO HAVE TO REDEFINE SUCCESS. INSTEAD OF GOING FOR, WE HAVE ENROLLED A MILLION PEOPLE. ARE WE REALLY CHANGES THE CRITIC OF RESEARCH. I THINK THIS GROUP WILL HAVE A TREMENDOUS RESPONSIBILITY ON UPON HADDING US DEFINE SUCCESS APPROPRIATELY. >> ,A MEN. THE QUESTION OF THE SEQUENCE OF THE NEXT STEPS THE COMMENTS YOU MADE, LET'S MAKE SMALL MISTAKES. SO THAT WE CAN BUILD A BASE FOR BIG SUCCESS AND FIGURE OUT WHAT ARE THE STEPS THAT WE SHOULD START WITH IS REALLY GOING TO BE THE MAJOR TOPIC FOR THIS AFTERNOON. THIS IS INCREDIBLY AMBITIOUS, AND HAS INCREDIBLE POTENTIAL OVER TIME, BUT MAKING THE RIGHT STARTING STEPS THAT ARE TRULY INFORMATIVE ABOUT THIS RESEARCH AND TRULY SETS THE GOWN WORK FOR DOING RESEARCH IN A MUORE INNOVATIVE KIND OF WAY. THERE ARE MANY TOUGH DECISIONS AHEAD AND I TURN TO ALL OF YOU FOR A LOT OF INPUT AS WE FACE EACH OF THOSE DECISIONS. ERIC MENTIONED IT WAS LIKE WRITATION DISSERTATION. THAT, UNFORTUNATELY IS STILL AHEAD OF US. THERE ARE MANY SUBDISSERTATIONS THAT ARE GOING TO NEED TO BE WRITTEN WRITTEN. WE ARE GOING TO BE ASKING YOU FOR ADVICE AND INPUT ON MANY OF THESE PIECES SO LET'S TAKE A BREAK NOTICE AND RECONVENE AT ABOUT 10 OF 11:0:00. ROB KALEB IS ON HIS WAY AND HE'S GOING TO JOIN US ABOUT 11 AND HE HE MAY HAVE SOME COMMENTS ON THE PREVIOUS DELIBERATIONS. HE'S THINKING VERY ACTIVELY ON HIS ROLE AS ACTING DEPUTY AT THE FDA AND POTENTIALLY COMMISSIONER BUT HE WILL HAVE A PERSPECTIVE ON THIS PROCESS AS WELL. BUT RIGHT NOW, LET'S TAKE ABOUT A 15 MINUTE BREAK AND THEN COME BACK AT I'D SAY, 10 OF, TOO START AGAIN. I'M DELIGHTED WE'RE ALREADY GETTING INTO THE HEART ISSUES. FOR EXAMPLE, HOW WE DEAL WITH QUESTIONS LIKE WHAT IF WE HAVE HIC OR DISEASE GROUPS. VAST NUMBERS IN VOLUNTEERS IN WE ARE BEGINNING TO DEVELOP TRAIT EGOS FOR - THESE HARD QUESTIONS AND YOU ARE GOING TO BE A QUICK KEY SOUNDING BOARD AS WE MOVE FORWARD ON THESE QUESTIONS. SO THE FIRST VERSION RIGHT AFTER. SO THIS, WONDERING GROUP OR GROUP OF REPORT WENT TO THE ADVISORY COMMITTEE DIRECTOR ON SEPTEMBER 17. AND ARE YOU WILLING TO TAKE THIS ON. -- WE HAVE BEEN PRETTY HARD AT WORK SINCE THEN AT FLUSHING OUT THE DESIGN AND PROCESS THAT WAS ORIGINALLY PUT UP HERE. I'M GOING TO SHOW YOU THE BIG PIECES OF WHAT WE HAVE ALREADY ISSUED SOLICITATIONS THIS IS DISCUSSION PART. THIS ISN'T A SPEECH. SO STOP ME AT ANY POINT WHERE YOU HAVE QUESTIONS ABOUT WHAT WE ARE PUTTING TOGETHER. CERTAINLY, ONE OF THE THINGS THAT WAS RECOGNIZED VERY EARLY IS THAT WE WOULD NEED YOU. SO YOU ARE THAT BLUE BOX. LL REPORT -- WHO'S RECOMMENDICH EGGS WILL, IN A FORMAL SENSE, GO THROUGH THE COUNCIL OF COUNCILS AND A DIRECT REPORT TO THE NIH DIRECTOR. THE PMIA PROGRAM OFFICE WILL BE ESTABLISHED AS PART OF THE OFFICE OF THE DIRECTOR. WE ARE ANTICIPATING THAT THE AWARDEES WILL BE OVER SEEN BITE PROGRAM OFFICE AND WE'LL PUT TOGETHER A STEERING COMMITTEE, AN EXECUTIVE COMMITTEE AND WORKING GROUP. SO THAT'S SORT OF THE BROAD STROKES OF HOW THIS WILL RUN. AND AN ABSOLUTELY CRITICAL PIECE IN THE OVERSIGHT WHEN THIS IS IN FULL IMPLEMENTATION WILL BE A COORDINATING CENTER, WHICH WILL BE IN CHARGE OF BRINGING TOGETHER AND INTEGRATING THE ACTIVITIES OF ALL THE PIECES THAT YOU'RE GOING TO HEAR ABOUT. SO THE FUNDING ANNOUNCEMENTS THAT HAVE BEEN PT OUT, THE TIME WE FIRST MADE THIS SLIDE WAS FOR THE COORDINATING CENTER FOR THE LARGE HEALTH PROVIDER ORGANIZATIONS FOR THE PARTICIPANT TECHNOLOGY CENTER, AND DIRECT VOLUNTEERS IS ACTUALLY A PART OF THE COORDINATING IN THE BIOBANK. WE'LL TALK A LITTLE LATER ABOUT THE QUALIFIED HEALTH CENTERS AND YOU'RE GOING TO HEAR A LOT ABOUT OUR DIRECT VOLUNTEERS PROCESS. WE HAVE NOT YET, ISSUED SOLICITATIONS FOR THE DIRECT VOLUNTEER HEALTH EXAMINES OR SPECIMEN COLLECTION OR FOR THE LABORATORY ANALYSES. THOSE ARE PART THE OF THIS ACTIVITY THAT ARE STILL URGE WAY. VERY BROADLY, THIS IS WHAT WE TO SEE IN TERMS OF NUMBERS. THE SOLICITATION ASKED EACH HEALTH PROVIDER ORGANIZATION TO RECRUIT 10,000 SUBJECTS IN ITS FIRST YEAR. THIS IS CALENDAR YEAR, NOT FUNDING YEAR, SO NUMBERS END UP SLIGHTLY DIFFERENT. BUT WE HAVE A GUESS ESTIMATE. AND THIS GETS US TO APPROXIMATELY A MILLION ENROLLEES BY 2019. SO HERE IS WHERE WE ARE RIGHT NOW. WE HAVE JUST COMPLETED THE FIRST AND SECOND LEVEL REVIEW FOR THE PILOTS. YOU'RE GOING TO HEAR DETAILS ABOUT EACH OF THESE FUNDING OPPORTUNITIES, AS I GO ON AND WE ARE CONVENIENCE YOUR ADVICE PRIOR TO MAKING THE FIRST SET OF AWARDS GLAD TO HAVE YOU ALL HERE. THE KEY ELEMENTS IN THE COORDINATING CENTER. THE COORDINATING CENTER HAS THREE ELEMENTS. ADMINISTRATIVE CORE, A RESEARCH SETTLEMENT CORE AND A DATA CORE. THE CHARGE FOR THE COORDINATING CENTER ADMINISTRATIVE CORE ARE THESE TASKS LISTED HERE. SO THE COORDINATING CENTER IS EXPECTED. THE PIOF THE COORDINATING CENTER IS EXPECTED TO BE TOGETHER WITH THE PERMANENT DIRECTOR. COCHAIRING OF THE STEERING AND EXECUTIVE COMMITTEES. THEY ARE CHARGED WITH AN EFFECTIVE TRANSITION FROM A PILOT PHASE THAT WE'RE ENGAGED IN NOW, AND CHARGED WITH THE PROTOCOL DEVELOPMENT AND OF THE MONITORING DEVELOPM AND PROTOCOL IMPLEMENTATION, INCLUDING WHAT WE HAVE BEEN TALKING ABOUT, THE DIVERSITY OF THE SAMPLE. THE COORDINATING CENTER WILL BE THE CENTER OF DIRECT FOR DIRECT VOLUNTEER OPERATIONS. THEY WILL BE CHARGED WITH FOR DIRECT VOLUNTEERS, SCHEDULING AND TRACKING BIOSPECIMENS, AND PHYSICAL EVALUATIONS, AND THEY WILL BE PROVIDING INSURANCE OF EFFECTIVE PROTOCOL IMPLEMENTATION AND PATIENT ENGAGEMENT FOR THE HPO'S. BUT THE HPO'S WILL BE CHARGED WITH IMPLEMENTING THEIR PART OF THE WORK. THE DATA CORE IS VERY MATERIAL AND CRITICAL PART OF THE COORDINATING CENTER. THE FUNKS ASSIGNED TO THE DATA CORE ARE SHOWN HERE AND THEY WILL BE CHARGED WITH ALL DATA ASPECTS AND WILL BE THE PLACE WHERE WE WILL EXPECT THE EXPERTISE ON CREATING INTERFACES THAT WILL INTEGRATE DATA FROM HEALTH I.T. RECORDS FROM BOTH THE HPO'S, AND FROM THE DIRECT VOLUNTEERS AND THE THIRD BIG PIECE OF THE COORDINATING CENTER IS THE RESEARCH SUPPORT, CORE. WE HAVE ASKED THEM TO TELL US HOW THEY CAN ESTABLISH AND OVERSEE A SECURE COMPUTING ENVIRONMENT WE ARE ANTICIPATING THE DATA FROM THIS WILL BE EXISTS IN AN ENVIRONMENT IN WHICH USERS ARE, HAVE CREDENTIALS AND ARE TRACKED AND THAT THAT UNIDENTIFIED OR INDIVIDUALLY IDENTIFIED DATA WOULD NOT LEAVE THIS SECURE, COMPUTING ENVIRONMENT. THE COORDINATING CENTER IS EXPECTED TO FIND AND DEVELOP THE ANALYTIC KIND OF TOOLS THAT ARE NEEDED TO WORK WITH THIS DATA SET. AND TO PROVIDE ACTUAL SUPPORT FOR THE USERS AT ALL LEVELS OF SOPHISTICATION, WHETHER CITIZEN SCIENTISTS OR THE MOST SOPHISTICATED GENERAL INVESTIGATORS, TOO USE THE DATA. LAB SERVICES AND LABORATORY SERVICES DEVELOP, THEY WILL BE THE INNER FACE TO IT AND WILL BE THE ACTUAL HOME FOR THE DATA ITSELF. AND THEY WILL BE THE PLACE WHERE QUALITY ASSESSMENT IS OVERSEEING. SO THOSE ARE THE THREE THE COORDINATING CENTER AND THOSE APPLICATIONS WILL BE COMING IN, IN ABOUT A MONTH AND YOU WILL BE LOOKING AT, WITH US, AT THOSE APPLICATIONS AFTER THEY HAVE BETWEEN THROUGH REVIEW. AT SOME POINT, IN JUNE. ANY COMMENTS ON THE COORDINATING CENTER FUNKS? >> SO I HAVE A QUESTION. SO IF SAMPLES, IF THE CENTER HAS SIMPLES AND A RESEARCHER SAYS, YOU KNOW, I DON'T NEED ACCESS TO THE DATA SET, THE LAB ANALYSIS, BUT I NEED THE ACTUAL SAMPLE, CAN SAMPLES LEAD >> THE SAMPLES WILL IN FACT BE IN THE BIOBANK. BUT THE COORDINATING CENTER WITH OUR HELP AND YOUR ADVICE, WILL NEED TO DEVELOP POLICIES FOR ACCESS FOR THOSE SAMPLES, AND THAT WILL BE A COORDINATING CENTER FUNCTION. SO WE DO NOT ANTICIPATE HAVING WHERE PEOPLE DIRECTLY K-G THE BIOBANK. THE BIOBANK IS REALLY JUST A REPOSITORY OF THE SAMPLES. THE ACCESS POLICIES FOR SAMPLE IT IS WILL BE A STEERING COMMITTEE CHARGE, AND THE ACTUAL IMPLEMENTATION OF THAT WILL BE THOUGHT COORDINATING CENTER. IS THAT YOUR QUESTION? >> YEAH, BUT I THINK IT MATTERS TO PARTICIPANTS JUST MAKING SURE THAT THEY UNDERSTAND ALL THE PEOPLE THAT CAN ACCESS WILL ACTUAL SAMPLE IS GOING TO BE IMPORTANT. >> ABSOLUTELY. AND ONE OF THE CORE PRINCIPLE THE FUND BEING ANNOUNCEMENTS IS PARTICIPANTS CAN DECIDE NO LONGER TO PARTICIPANT AND WHAT INCLUDES THE BIOBANK HAS TO HAVE THE CAPACITY TO REMOVE AND DESTROY SAMPLES IF THE PARTICIPANT ELECTS THAT. SO THAT WAS WRITTEN INTO THE BIOBANK. BUT THE RESPON FOR KNOWING, AND MAKING SURE PARTICIPANTS ARE AWARE OF THE CHAIN OF CUSTODY AND ACCESS FOR THEIR SIMPLES IS A RESPONSIBILITY WE WILL ASSIGN TO THE COORDINATING CENTER WE HAVE AN EXPECTATION THAT PEOPLE NEED TO BE INFORMED. THEY HAVE THAT'S ALREADY BEEN USED OR ANALYSIS THAT CAN'T NECESSARILY ENSURE WITHDRAWL FOR WORK THAT IS ALREADY UNDERWAY. AND SO THERE IS A PROVISION WE NEED TO ESTABLISH THAT IF DATA ANALYSIS HAVE ALREADY BEEN DONE. YOUR DEIDENTIFIED DATA POTENTIALLY PART OF THOSE AND WE CAN'T PULL IT OUT. BUT WE CAN CERTAINLY LIMIT ITS FUTURE USE. THE REKNIT OF THIS COORDINATING CENTER IS BIGGER AND AND DEEPER THAN I'VE ALREADY SEEN. IS THIS A PRACTICAL REALITY FOR THIS >> WELL, I HOPE SO. THE BUDGET IS ALSO BIGGER THAN MOST PROJECTS. WE ANTICIPATE AND WE DIVIDED IT INTO THESE THREE BLOCKS. BECAUSE OF A RECOGNITION THAT PARTICULARLY THE DATA CAPACITY MAY NOT BE PRESENT IN ACADEMIC. WE THINK THAT A AND C ARE TASKED MANY ACADEMIC COORDINATING CENTERS WOULD BELIEVE QUITE ABLE TO DO. THE CREATION OF THIS UNTIL COMPUTING ENVIRONMEN, AND CAPACITY TO HAM AND MEET FEDERAL SECURITY REQUIREMENTS FOR THE DATA, ARE ACTUALLY WILL, I THINK, REQUIRE A SUCCESSFUL APPLICANT HAVE DATA HANDLING STRENGTHS AND DATA CAPACITIES THAT FAR EXCEED WHAT ARE NORMALLY NT IN ACADEMIC SITES. SO SO I'M GLAD YOU'RE WORRYING WITH US. BUT I BELIEVE THERE ARE MANY COORDINATING CENTERS WITH CAPACITIES, TASKS THAT'S A AND C. BUT TASKS IS BIGGER THAN MOST THINGS. >> I'M ANTICIPATING WHEN THESE APPLICATIONS COME AN, WE'LL HAVE TCH AREAS AND WHICH WILL ALLOW TO BUDGET AND BE D THE WAY WE HAVE WRITTEN WEAKER ON. THESE THREE SOLICITATIONS. THESE THREE COMPONENTS USE A U- U-24. U2C MECHANISM WHICH ALLOWS US THE FLEX WE'RE FLEXIBILITY TO AWARD A AND C TO ONE SIDE AND B TO ANOTHER. AND REQUIRES THAT THE APPLICANTS COME IN WITH US, WITH BUDGETS SEPARABLE FOR THESE THREE COMPONENTS. AS WE TALK ABOUT THE REVIEW, I THINK YOU MENTIONED THAT PLUGS WILL BE AVAILABLE IN ABOUT A MONTH AND OUR COMMITTEE WILL REVIEW THEM IN JUNE. >> YEAH -- >> ACTUALLY THAT'S NOT MY QUESTION >> BUT JUST JUST SO TO CLARIFY. YOU WILL BE PERFORMING SOME OF THE ANALOGOUS ROUGHLY TO SECOND-LEVEL REVIEW. SO THERE WILL BE AN EXPERT PANEL, CONVENED BY A VERY EXPERIENCED SET OF REVIEWERS IN THE CENTER FOR SCIENTIFIC REVIEW AND THEY WILL PROVIDE PRETTY DETAILED REVIEWS OF EACH OF THESE COMPONENTS AND PRIORITY RECOMMEND EGGS. WE WILL THEN REVIEW THOSE VERY CAREFULLY, AND PREPARE SUMMARY OF THAT, AND YOU'LL SEE THE FULL SUMMARY STATEMENTS, PRIOR TO MAKING THE FINAL AWARD DECISIONS. >> ON THAT NOTE, ON THE SCIENTIFIC REVIEWERS, I THINK THERE'S CONCERN FOR THOSE OF US FROM THE WORKING GROUP, THE ORIGINAL PHASE THE SPIRIT OF THIS, WONDERING GROUP, AND THE INNOVATION. I WANT TO MAKE SURE THAT WHOEVER'S CONVENING THOSE GROUPS, THAT INFORMATION GOES FORWARD, WE WANT TO THINK OUT OF THE BOX. WHAT WILL THE MAKE UP OF THE GROUP BE? WILL IT BE THE WORKING GROUP OR IS ITING FROMMAL ACADEMIC. >> [SPEAKING AWAY FROM MICROPHONE] >> WHAT ROLE, WHAT WEIGHT IS OUR OPINION GIVEN. SO YOU ANSWERED IT. >> WE HOPE TO HAVE A VERY CAREFUL DECISION MAKING PROCESS ABOUT THIS SUITLY CRITICAL COMPONENT. GREG. >> AND WE CAN RETURN TO SOME OF THESE DETAILED ISSUES IN CLOSED SESSION LATER >> IT SEEMS TO HERE'S REGARDING THE USE OF A DATA ENCLAVE TO ALLOW MORING FROMMAL SCIENTISTS, AND STATUS SCIENTISTS TO BRING QUESTION TO DATA, AS OOPPOSED BRING DATA TO QUESTIONS, IS PROBABLY THE RIGHT GENERAL STRATEGY SEEMS THERE'S GOING TO BE IMPORTANT THINGS TO WORK OUT. WHEN YOU HEAR PEOPLE TALK ABOUT DATA ENCLAVES, THEY TALK ABOUT APPROPRIATELY QUALIFIED USERS. WHAT APPROPRIATELY QUALIFIED MEANS, WHETHER THAT HAS TO DO WITH CREDENTIALS OR ACCEPTING A CULTURE OF TRANSPARENCY AND INTEGRITY. AND THE USE OF AN ENCLAVE MODEL IS ESSENTIALLY, IT CREATES A COMPLETELY DETAIL AUDIT TRAIT OF EVERY QUESTION ASKED AND EVERY ANSWER DELIVERED. AND I THINK, YOU KNOW, IT WOULD BE VERY IMPORTANT STRATEGICALLY TO THINK ABOUT WHEN AND HOW DOES THAT AUDIT TRAIL BECOME PUBLIC. >> ONE OF THE WORKING GROUP CONVERSATIONS WAS AROUND -- ONE OF THE WORSE CASE SCENARIOS IS IF A PARTICIPANT MOTIVATED, EXCITED, ENGAGED, CREDIBILITIES DATA AND HEARS NOTHING FO HEAR -- AND CONT RIBUTES DATA, AND DOESN'T HEAR ANYTHING. SO ERRING ON THE SIDE OF CAREFULLY EXCEEDING IT'S TRAILING AND IS THIS STUDY GOING ON. PEOPLE WOULD WANT TO KNOW THAT ON A REGULAR BASIS, IF YOU'RE GOING TO ENGAGE THEM AND ASK THEM FOR ANOTHER BIOSAMPLER OR ASK THEM TO FILL OUT A DIET SURVEY HATER. THEY NEED TO KNOW, SOMETHING IS HAPPENING FROM THEIR PREVIOUS INVESTMENT. SO THE WORKING RECOMMENDATION WAS TO CLEARLY ERR ON THE SIDE OF INCREASED TRANSPARENCY AND FREQUENCY OF THAT FEEDBACK IN ORDER TO GIVE THE PARTICIPANTS A SENSE OF SOMETHING'S HAPPENING, THEREFORE, I WANT TO GIVE MORE. >> AND THIS NOG OF REASONABLY FREQUENT. PERHAPS FREQUENCY DETERMINED BY PARTICIPANTS ARE OF INTERACTION WITH THIS STUDY. IT'S GOING TO BE A RECURRENT THEME AS WE TALK ABOUT THIS. >> I WANTED TO JUST ADD ANOTHER BENEFIT TO FREQUENCY. ANY TIME YOU'RE TRACKING A LONGITUDINAL COHORT, IT'S OPTIMAL TO GET IN TOUCH WITH THEM, EVERY 6 MONTHS. EVERY 6 MONTHS, 6 MONTHS IS WHAT EXPIRES, THE POST OFFICE, CHANGE OF ADDRESS. IT'S ONE WAY TO KEEP TRACK OF CHANGE WITHIN THE POPULATION AND THAT CONTACT CAN BE NOT ONLY GIVING THEM INFORMATION OF WHAT HAPPENED WITH THE STUDY, BUT IT'S ALSO BIRTH DAY CARDS, THINGS LIKE THAT, THAT MAKE THEM FEEL A PART OF THE FAMILY AND FEEL INFORMED. ONE OF THE ISSUES, I'M JUST THINKING ABOUT THIS, WE MAY HAVE TO ADDRESS IT IT. IT MAY NOT BE A PROBLEM. BUT I DIDN'T REALIZED WE WERE GOING TO PLAY A ROLE IN REVIEWING, THE EXTENT OF WHICH MANY OF US MAY HAVE CONFLICT OF INTEREST WITH THE APPLICANTS THAT COME IN, TEND TO BE IN CONFLICT. >> RIGHT. RIGHT. SO WE WILL TALK ABOUT THAT THIS AFTERNOON BOTH AT THE CONCLUSION OF THIS OPEN SESSION, AND THEN A LITTLE BIT MORE IN CLOSED SESSION. I THINK THE ISSUES THAT WE'RE TALKING ABOUT NOW, ARE NOT ONES THAT WE SEE YOU AS IN CONFLICT N ALSO, I DON'T SEE YOU AS IN CONFLICT ON SOME OF THE POLICY DECISIONS BUT CLEARLY, WHEN IT COMES DOWN TO AWARDS, WE WILL NEED TO IDENTIFY AND RELATIONSHIPS WITH POTENTIAL AWARDEES, WE WILL NEED TO IDENTIFY CONFLICTS AND WE'LL BE WORKING TOGETHER TO DO THAT. THERE ARE MANY QUESTIONS HERE THAT NEED ADVICE AND I REALLY VERY MUCH HOPE YOU'RE NOT OUT OF THE ROOM VERY MUCH OF THE TIME. BUT THAT'S GOING TO BE AN ISSUE. >> I'LL JUST ADD ONE MORE THING. YOU'LL SEE IT WHEN WE TALK ABOUT THE D.B. PILOT. OUR FOOD AND WATER BACK ABOUT THE SYSTEM IS POTENTIALLY MORE THAN DALEY FREQUENT. OVER TIME SOMEONE PROVIDES DATA, WE'RE PROVIDING BACK TO THEM. THIS IS HOW IT COME PAIRS WITH ANOTHER PEOPLE IN WHATEVER KIND OF PREFERENCE THEY WILL LIKE TO HAVE THIS IN I THINK OUR FEEDBACK LOOPS ARING FROMMAL >> ONE OF THE THINGS TO LEARN IN THE DIRECT PILOT IS HOW TO TAILOR, HOW TO PERSONALIZE THE FEEDBACK IN WAYS THAT MAXIMIZES PEOPLE'S ENGAGEMENT AND MAKES IT INTERESTING AND FUN AND THAT MAY NEED AS MUCH PERSONALIZATION AS ANYTHING. BILL IS GOING TO BE LEARNING HOW TO DO THIS. BUT IT IS, I THINK, ONE OF THE THINGS THAT IS REALLY EXCITING. CALL OUT TO MAKE SURE THE ADVISORY PANEL IS AWARE, I'VE BEEN THINKING ABOUT IT, KAREN HAS BEEN THINK GOING IT AND WE PROBABLY WANT YOU TO THINK ABOUT IT, TOO. GWEN AND JOSE KNOW, I HAVE HAD AN INTENSE, ONGOING INTEREST IN THE DATA CENTER AND, YOU KNOW, THE CORE AND HOW THAT'S GOING TO BE APPROACHED THESE ARE COOPERATIVE AGREEMENTS SO THEY'RE NOT AGREEMENTS AND THEY'RE NOT CONTRACTS. SO THE TERMS AND THE CONDITIONS THAT GO INTO THE NOTICE OF AWARD ARE A BIG DEAL. I HOPE IN CLOSED SESSION, THERE MAY BE AN OPPORTUNITY TO TALK ABOUT THAT OR NOT. T NECESSARILY, THE REVIEW, BUT TERMS OF AWARD BECAUSE YOU KNOW, IF YOU'RE RUNNING THE DATA CE THAT IS PULLING DATA FROM ACROSS THE COUNTRY ON A LOT OF DIFFERENT PEOPLE, THERE'S RAMIFICATION THAT IS GO ALONG WITH THAT. EXCITING TUNES WITH RAMIFICATIONS. THE OTHER PIECE OF THAT. THE SOFTWARE, WHAT A TREMENDOUS OPPORTUNITY TO CREATE A COMMON GOOD FOR THE COUNTRY. TO DEVELOP REALLY GREATLY, ROBUST, WIDELY USEABLE SOFTWARE, TO BE ABLE TO DO THIS KIND OF ANALYSIS, THAT IS NOT LOCKED UP IN SOMETHING PROPRIETOR AND IS BEING FUNDED BY TAXPAYER DOLLARS. SO JUST TYING IT UP FOR EVERYBODY. THAT'S SOMETHING I'VE BEEN INTERESTED IN, AND I HOPE WE CAN PAY SOME ATTENTION TO IT >> YEAH, ABSOLUTELY AND WE ACTUALLY, JOHN AND I WERE BOTH ON A CALL YESTERDAY. AND THIS IS THE RATE OF CHANGE AND SPACE AND THE POTENTIAL FOR IN PROGRAM BEING A CATALYST FOR SOME VERY IMPORTANT CHANGES, I THINK IS ENORMOUS. OKAY. PIECE TWO IN OUR CURRENT SOLICITATIONS IS FOR HEALTH PROVIDER ORGANIZATIONS. THE ADVISORY COMMITTEE DID SUGGEST TO US, THAT PROBABLY TWO QUARTERS TO -- OF THE APPLICANTS WOULD COME FROM HEALTH PROVIDER ORGANIZATION ENROLLMENT SITES AND SO WE HAVE SOLICITATION FOR MAJOR HEALTHCARE PROVIDER ORGANIZATIONS RELATIVELY LOOSELY DESIGNED, TOO ESTABLISH STRUCTURES TO ENROLL PARTICIPANTS, INCLUDING POTENTIAL FAMILY MEMBERS AND HELP MEET THE TARGETS OF OVER REPRESENTATION OF UNDER REPRESENTED GROUPS. THEY ARE CHARGED WITH ESTABLISHING STRATEGIES FOR EFFECTIVE LOCAL PARTICIPANT ENGAGEMENT AND MONITORING PARTICIPANT ENGAGEMENT AND REENROLLMENT. THEY'RE EXPECTED TO HAVE EXPERTISE IN EACH SITE N PARTICIPANT ENGAGEMENT AND WILL STRATEGIES FOR THAT. WE HAVE SET TARGETS IN THIS SOLICITATION THAT EACH SITE ENROLL IN THE FIRST YEAR 10,000 ENROLLEES. THESE ARE TO BE AWARDED IN, WITH A KIND OF MECHANISM THAT WAS ACTUALLY PRETTY MUCH PIONEERED IN THE COLLABTORY, AND GREG IS VERY FAMILIAR WITH, OF PHASED AWARD, WHERE THERE ARE CERTAIN THINGS TO BE ACCOMPLISHED IN YEAR ONE. IF YEAR ONE IS SUCCESSFUL, THE N IRK H PUT THEM IN A REVIEW PROCESS, REVIEWS THE PROCESS TO THE MILESTONE, MAKES A DECISION OF THE SUBSEQUENT ENROLLMENT PROCESS. AND THAT IS A WAY FOR US, IN SOME WAYS TO, IDENTIFY THINGS THAT ARE INN WORKING REL LIVELY EARLY. WE HAVEN'T SAID MUCH MORE ABOUT THE KINDS OF NETWORKS OF ORGANIZES THAT COULD COMPETE FOR THIS. AND INTENDED THAT THIS BE FLEXIBLE AND FROM OUR EARLY STAGE OF INQUIRIES, WE THINK THAT A VARIETY OF ORGANIZATIONS ARE INTERESTED IN MEETING THIS. FOR A VERY LARGE HEALTHCARE SYSTEM, THESE ARE ACTUALLY NOT LARGE NUMBERS AND SO THESE ARE NOT I THINK, UNACHIEVABLE TARGETS. FOR NETWORKS OF SMALLER UNITS, THESE ARE BIG NUMBERS. FEDERALLY QUALIFY NETWORKS. THESE MAY BE HARDER TARGETS TO REACH, BUT I THINK THEY ARE NOT UNREALISTIC NUMBERS AND THE PROJECTED ENROLLMENT TABLE YOU NUMBERS. WE ARE PROPOSING AT THIS POINT, TOO ENROLL 7 OF THESE. WE HAVE FLEXIBILITY IN THAT NUMBER BUT THAT'S WAY WE HAVE TALKED ABOUT THIS PART OF IT. SO THE IMPORTANT QUESTIONS AND COMMENT THAT IS JOHN RAISES WILL BE PARTLY IMPLEMENTED AT THE HEALTH PROVIDER ORGANIZE SITE, AND PARTLY, RESPONSIBILITY OF THE DATA COORDINATING CENTER, AND IT REALLY WILL BE CAN WE BUILD THOSE BRIDGES EFFECTIVELY BETWEEN THE HPO'S, AND THE DATA COORDINATING CENTER THAT'S WHERE THE KEY INNER FACE WILL HAVE TO HAPPEN. ANY QUESTIONS ABOUT THE HEALTH PROVIDER ORGANIZE PIECE? >> WHEN ONE LOOKS AT ALL OF THESE, THE SIX TOTAL, THE COORDINATION AND I KNOW WE'RE SAYING DATA COORDINATING CENTER. THE COORDINATION, THERE'S GOING TO BE A LOT OF PARTNERS, SOME OF THEM HAVE WORKED WITH EACH OTHER BEFORE AND SOME HAVEN'T, AND WE KNOW FROM NETWORKS LIKE CTSAS, I CO-CHAIRED THE IOM STUDY ON NA NETWORK, THAT IT'S VERY HARD TO DO THE KIND OF CULTURE CHANGE WE'RE TRYING TO DO. THE TRAN FORMATIONAL PIECE AND ALL THESE DIFFERENT KINDS OF ACTORS, WORKING TOGETHER, EFFICIENTLY, AND FAIRLY QUICKLY. THE OTHER THING YOU DON'T WANT TO DO IS SAY, LET'S TAKE 5 YEARS AND NOT JUST $120 MILLION, BUT PROBABLY A BILLION AUTHORIZE, WHICH MAY SET THIS UP. WHICH MAY SEEM MORE LOGICAL, BUT NOT EFFECTIVE >> IT WAS MENTIONED EARLIER, THE ORGANIZATIONS, THE HPO APPLICANTS WILL PROVIDE A PLAN ON HOW THEY'RE GOING TO DO THAT, BUT IN IN THE ACTUAL TERMS AND CONSCIENCE OF THE AWARDS. WE IS SET SOME EXPECTATIONS. THE NIH HAS SOME EXPERIENCE OF RUNNING MULTI SITE COHORT STUDIES. NOT AT THIS SCALE. BUT THIS IS A PART OF THE DECISION, THIS IS NOT BRING IN ALL YOUR LEGACY COHORTS. THIS IS AND IF YOU HAVE LEGACY DATA, GREAT. BUT THE ENROLLEES IN THIS COHORT ARE ENROLLED IN THIS COHORT AND SO IT WILL HAVE A COMMON PROTOCOL AND COMMON DATA ELEMENTS FOR THE KEY THINGS. BUT A LOT OF THE QUESTIONS YOU'RE RAISING ABOUT HOW MUCH OF THE PLANNING SHOULD BE LEFT TO THE GRANTEES, VERSUS HOW MUCH WILL BE CENTRALIZED, I THINK THE ADVICE FROM THE WORKING GROUP IS A VERY SIZEABLE AMOUNT NEEDS TO BE A CENTRAL FUNCTION AND NA WILL BE SOMETHING WE'LL TALK MORE ABOUT THIS AFTERNOON. BUT IT'LL BE AN ONGOING NEED FOR DEAFNESS AND BALANCE. >> AND JOSE, THE OTHER THING THAT'S STRIKING TO ME, THAT ARE DIFFERENT FROM OTHER THINGS AND NIH AND OTHERS HAVE DONE, THIS IDEA OF PEOPLE AS PARTNERS GOING TO BE REALLY BOTH GNARLY AND WONDERFUL. >> RIGHT. I HAVE A QUESTION ABOUT THAT, THE ENGAGEMENT PIECE, PARTICULARLY, ON SOME OF THE ADVISORY BOARDS. LOOKS LIKE FROM ONE OF THE EARLIER SLIDES THAT A LOT OF THE ADVISORY BOARDS LIVE AT THE COORDINATING CENTER AND NOT AT PME. LIKE, THIS IS THE ADVISORY PANEL FOR PMI SO WHERE THERE BE DUPLICATE BOARDS OR WHO OWNS THAT PIECE OF THE ENGAGEMENT >> WE'RE GOING TO NEED HELP WITH THAT QUESTION, AND WE DO NEED TO SET CLEAR EXPECTATIONS FOR THE STRATEGIES FOR PARTICIPANT ENGAGEMENT. I WILL ADD, ONE THING THAT MAKES THIS DIFFERENT IS THAT AS WE DEVELOP A SET OF PAPS, WE ACTUALLY, SO PEOPLE WHO HAVE VOLUNTEERED, BECOME PARTICIPANTS. THEY'RE NOT -- WE'RE NOT NECESSARILY WORKING ONLY THROUGH OUR INTERMEDIARIES AT PARTICIPANT ENGAGEMENTS. I'VE NAUGHT A LOT ABOUT A VERY CRITICAL AND IMPORTANT PIECE OF THIS PROCESS, AND ONE THAT'S GOING TO REQUIRE A LOT OF FURTHER THOUGHT. I'VE BECOME ACUTELY AWARE. IN SPITE OF SHARON SAYING THAT WE HAVE MADE PROGRESS IN PARTICIPANT ENGAGEMENT AT THE NIH, HOW FAR WE HAVE TO GO AND HOW MUCH AND HOW OFTEN PARTICIPANT ENGAGEMENT PROCESSES, HAVE A LITTLE BIT THE QUALITY OF BRINGING IN A COUPLE OF VOICES FROM THE ADVOCACY COMMUNITY AND AREN'T REALLY SUBSTANTIVE OR QUALITATIVE WAYS TO DO THIS. SO I THINK WE REALLY HAVE TO BREAK THE RULES OF WHAT'S EXISTED BEFORE, AND DEVELOP BETTER AND MORE -- ENSURE MORE SUBSTANTIVE ENGAGEMENT. I WAS JUST LOOKING AT A SET OF PROPOSALS FOR CANADIAN NETWORKS ON KIDNEY DISEASE AND HAD A VERY ACTIVE PARTICIPANT IN ENGAGEMENT PROCESS AND I WAS VERY STRUCK. I OVERSEE KIDNEY RESEARCH FOR SOME TIME AND I WAS STRUCK AT HOW THE PARTICINT ENGAGEMENT RESULTED IN QUESTIONS ABOUT SYMPTOM MANAGEMENT AND ADRENAL TEASE POPULATION, THAT NEVER CAME UP WHEN WHEY DIDN'T HAVE THE PARTICIPANT VOICE IN A VERY SUBSTANTIVE WAY. I REALLY THINK WE HAVE TO DO THIS BETTER THAN WHAT'S BEEN DONE BEFORE. BUT I DON'T HAVE -- AND, YOU KNOW, YOU ARE VOICES HERE IN THIS ROOM TO TALK AND THINK ABOUT US ABOUT HOW IS IT GOING GOING. BUT WE DO NEED TO MAKE IT PART OF THE ENTIRE CULTURE OF THIS WHOLE PROGRAM. AND WE NEED HELP IN THINKING ABOUT THAT. COMMENTS? >> GOING BACK TO DAVID'S POINT EARLIER ABOUT REPRESENTATIVE SAMPLE, IT'S TOO LATE TO ADD BULLET POINTS. BUT ONE THAT WOULD BE IMPORTANT TO THINK ABOUT, THE NEXT BEST THING TO HAVING A REPRESENTATIVE SAMPLE IS KNOWING HOW UNREPRESENTATIVE YOUR SAMPLE IS. SO WHAT THAT MEANS IS DEFINING A SAMPLING FRAME, DEFINING IMPORTANT SUBPOPULATIONS AND RESPONSE RATES ACCORDING TO SUBPOPULATION AND RECRUITMENT METHOD. THAT'S GOING TO BE CHALLENGING BECAUSE THESE ORGANIZATIONS ARE GOING TO BE DIVERSE. SO EVENING SAYING WHAT IS THE DEFINITION OF A SAMPLING FRAME. BUT IT SEEMS TO ME, THAT'S GOING TO BE A REALLY IMPORTAN TASK TO GET PEOPLE AROUND THE TABLE AND SAY, CAN WE COME UP WITH A COMMON DEFINITION OF A SAMPLING FRAME >> YES. THANK YOU. >> I THINK THE FACT YOU'RE DOING IT AS A COOPERATIVE AGREEMENT, YOU'RE GOING TO HAVE MULTIPLE ORGANIZES AND I THINK IT'S SOMETHING THAT IS ABOUT HAVING THEM SIT AROUND A TABLE AND HAVING THE CONVERSATION. I SEE DIFFERENT ORGANIZE THAT IS HAVE ACCESS TO DIFFERENT SUBPOPULATIONS AND I THINK IT'S PARTICULAR BE COORDINATED BUT I AGREE, YOU HAVE TO BE EXPLICIT ABOUT IT AND MAKE SURE THAT'S SOMETHING WE HAVE OUR EYES ON. >> WE'RE DOING SOME OER PROJECTS, SOME MAJOR WORK WITH MAJOR HEALTHCARE PROVIDER ORGANIZES AND SOME OF THEM DO HAVE VERY SIZEABLE INNERTEA POPULATIONS, VERY SIZEABLE POPULATIONS THAT CAPTURE SOME OF THE UNDER SERVED. THEY, HOWEVER, CAPTURE PEOPLE ARE GETTING HEALTHCARE AND DIMPLE, AND AND THAT'S WHY TO DO THE PILOT WORK HAS EMERGED -- CAPTURE A POPULATION THAT MOST HEALTHCARE PROVIDER ORGANIZES DON'T M I JUST WANT TO JUMP OFF FOR A SECOND, AND PUT ON MY METHODOLOGY GEEK HAT. KEEPING IN MIND, YOU KNOW, WE ARE TALKING ABOUT, YOU KNOW, SIGNIFICANT EVOLUTION IN THE METHOLOGIES OF HOW WE'RE, YOU KNOW, SO ALL THIS DUG IS GOOD. IT'S ALL IMPORTANT. I ALSO WANT, IT WOULD BELIEVE GREAT TO KEEP MINDS OPEN THAT WHEN WE TALK ABOUT THE SAMPLING FRAME, WE TALKED ABOUT, YOU KNOW APPLYING THAT POPULATION, THAT THE METHODS YOU WINE UP USING TO ANALYZE IS LARGE, DIVERSE, MESSI, NOISY, DATA SETS MAY OR MAY NOT COMPORT WITH THAT LOGICAL, YOU OTHER THAN, SET OF HOW WE'RE SETTING UP STUDIES. SO IT'S GOOD. THAT'S WHERE WE ARE. AND THAT'S WHAT WE KNOW. BUT AS WE MOVE TO THE NEUROMETHODOLOGIES, IT'S GOING TO BE IMPORTANT TO STEP BACK. JUST IN THE CONTEXT OF THE GREAT DISCUSSION >> YUP. >> YUP. THANK YOU. OKAY. SO NEXT PHASE ON THE STREET IS FOR THE PARTICIPANT TECHNOLOGY FROM. THIS SITE WILL BE CHARGED WITH MOBILE APPLICATIONS DEVELOPED IN THE PILOT PHASE FOR ENROLLMENT AND REGULAR ENGAGEMENT OF PARTICIPANTS, CHARGE 1 WE CALL THAT OUR PARTICIPANT INTERFACE AND WE'RE GOING TO GET TO WORK ON BUILDING A PROTOTYPE FOR THAT VERY SOON AND THEN, WE ANTICIPATE, IT'S GOING TO HAVE TO BE CONTINUALLY UPGRADED, SORT OF LIKE THOSE, PPS ON YOUR PHONE THAT, TELL YOU EVERY MONTH OR SO THAT THAT'S AN UPGRADE. L THAT'S KIND OF WHAT WE THINK OUR PARTICIPANT ENGAGEMENT INTERFACE IS GOING TO HAVE TO PROVIDE. WE SUMMER RECOGNIZE THAT THERE WILL BE POPULATIONS WHERE THE SMART PHONE ISN'T THE WAY TO BE THE INNER FACE AND SO WE ARE IMAGINING THAT WE WILL BE EXPECTING THE DEVELOPMENT OF PHONE BASE AND WEBSITE AND ACTUAL HUMAN BEING BASED INTERFACES SO THAT'S ALL THE PROTOTYPE INTERFACE PIECE. BUT IN ADDITION, WE ARE VERY EXCITED ABOUT SOME OF THE THINGS ALREADY MENTIONED EARLIER TODAYOF TECHNICA L EXPERTISE FOR VARIOUS DEVICES ARE CENTER BASED APPROACHES INCLUDE WHAT GREG MENTIONED, COGNITIVE FUNCTION TESTING OR OTHER MEASURES SOME OF THIS WILL START AS PILOTS AND POTENTIALLY, AS APPROPRIATE FOR THE SCIENTIFIC QUESTION, BE IMPLEMENTED MORE WIDELY ACROSS THE COHORT. IT'S EXCITING TO THINK THAT SEIZE SENSORS MIGHT HELP MEASURE ENVIRONMENTAL VARIABLES OR LEARN HOW PEOPLE MOVE THROUGH SPACE, AND WHAT THAT TELLS US ABOUT THEIR IMPACT. MAYBE EVEN WHAT THEIR SOCIAL NETWORKS ARE LIKE. SO THERE ARE MANY EMERGING IDEAS IN THE TECHNOLOGY AND USE OF GADGETS THAT CONNECT US AND WE HOPE TO HAVE SOME VERY INNOVATIVE THINKERS, AND A GOOD PROCESS TO ENSURE THAT OUR OUR ENGAGEMENT OF PARTICIPANTS IS FILLED WITH GOOD IMPLEMENTATION CAPACITIES AND GOOD IDEAS. >> SO THE COMMUNICATIONS GROUP WOULD HAVE A PUBLIC FACING WEBSITE. BUT THE GROUP WOULD HAVE A WEB PORTAL THAT ENGAGES PARTICIPANTS IN THE RESEARCH? >> YEAH. SO WE'LL TALK IN CLOSED SESSION ABOUT THE DEVELOPMENT OF THE COMMUNICATION INTERFACE, WHICH IS GOING A LITTLE AHEAD OF THIS. WE ARE GOING TO HAVE SOME INTERESTING CHALLENGES, IN ENSURING A SEAMS TRANSITION OF WHAT WE DEVELOP IN THE COMMUNICATIONS ASPECT TO THE PARTICIPANT TECHNOLOGIES AND ACCORDING CENTER. IN FACT, I AM WORRIED THAT WE DIDN'T PERHAPS SPECIFY SOME OF THOSE TRANSFER POINTS AS WELL AS WEEK HAVE, AND THAT WILL BE AN AREA THAT WE HAVE TO COLLECTIVELY WORRY ABOUT. >> THIS GOES BACK, WE WERE ALREADY FEELING A SENSE THAT COORDINATING CENTER WAS ALREADY WAY TOO BIG, RIGHT? SO TO ADD ON ALL OF THE TECHNOLOGY COMPONENTS ON TOP OF IT, IN SOME WAYS, THOUGH, THEY HAVE TO BE MORE INTEGRATED. THE PARTICIPANT TECHNOLOGY CENTER, AND COORDINATING CENTER WILL HAVE TO WORK TOGETHER CLOSELY, EVEN WITH A DATA SHARING HANDSHAKE BACK AND FORTH, IT'LL NEED TO HAPPEN. BUT WE FELT THAT AT THE END OF THE DAY, IT WAS BETTER TO HAVE A SEPARATE FOLK FOCUS ON THE TECHNOLOGY PIECE AND FIGURE OUT WAYS TO WORK CLOSELY TO MAKE THAT HAPPEN. WE HAD A PRETTY GOOD IDEA OF A VERY LONG TASK LIST AND TRY TO BREAK IT INTO THE RIGHT PIECES WAS THE SENT OF A FAIR AMOUNT OF INTERNAL DISCUSSION. I THINK WE HAVE GOT THEM ABOUT RIGHT, BUT THE CORNERS AND OVERLAPPING AREAS WILL BE ONES THAT WE HAVE TO WORK ON AND WORRY ABOUT. WE'RE PRETTY WELL AWARE OF THAT BUT HAVEN'T NECESSARILY SOLVED IT ALL. >> SO THIS IS AN AREA, OBVIOUSLY, WHERE THINGS ARE MOVING REALLY, REALLY FAST >> RIGHT >> AND WE'RE GOING TO MAKE A BET, A 4-5-YEAR BET, TODAY, TOMORROW, SOMETIME SOON, IT'S VERY LIKELY THAT OTHER GROUPS, COMPANIES WILL EMERGE DURING THE COURSE OF THAT FOUR, FIVE YEARS. DID THE WORKING GROUP TALK ABOUT HOW TO SHIFT ON THE FLY WITH THIS SORT OF THING OR DO THESE HAVE THE OBJECTABILITIES FOR BRING FIGURE THINGS YOU CAN'T ANTICIPATE TODAY >> ACTUALLY, THINK THE NIH LEADERSHIP IS GOING TO HAVE TO PLAY A VERY CRITICAL ROLE IN THIS SHIFTING SENSORRED TECH APP DEVELOPMENT. SOME OF US HAVE SHIFTED SO I THINK THINKING ABOUT DEVICES, AND THAT IS THE WAY, WE NEED AN INTERFACE FOR OUR PARTICIPANTS. THAT'S KIND OF BULLETS ONE AND TWO. BUT FOR THE USE OF SENSOR DEVICES. THINK OF THIS IS AS PILOTING AND MOVING INCREMENTALLY, MAKE MALL MISTAKES, RATHER THAN BIG ONES AND IT'S POSSIBLE THAT SENSOR DEVICES MAY CHANGE AND BE USED ON SUBGROUPS AS THE STUDY EVOLVES, IT IS LIKELY AND THAT PUBLIC-PRIVATE PARTNERSHIPS CAN BE USED TO AMPLIFY OUR ABILITY TO CAPTURE NOVEL TECHNOLOGY MIMES THESE PARTNERSHIPS HAPPEN BEST IN BETHESDA, AND SOMETIMES THEY ARE BEST NEGOTIATED BY OUR MAJOR AWARDEES WE WANT THE FLEXIBILITY TO LET THEM HAPPEN AND NOT PRECLUDE PARTNERSHIPS THAT EVOLVE AT THE LEADERSHIP TIMES WE PUT TOGETHER THIS WAY. BUT ALSO, TOO PRESERVE THE CAPACITY OF THE NIH TO BE THE BRIDGE THAT BUILD THIS IS. SOMETIMES EVEN THE WHITE HOUSE IS THE BRIDGE SO THIS IS COMPLEX. BUT HOPEFULLY, WE'RE SETTING UP A STRUCTURE HERE, THAT WILL ALLOW THE NEEDED FLEXIBILITY. I THINK YOU'RE EXACTLY RIGHT. IF WE STARTED THE STUDY EIGHT YEARS AGO. THERE WOULDN'T BE ANY SMART PHONES IN IT. SO WE HAVE TO THINK AHEAD, FOUR, FIVE YEARS FROM NOW, THIS WOULD ALL BE VERY DIFFERENT. SO I REALLY FEEL THE PTC SHOULD IN PART, BE PAYING TENACIN TO THOSE EMERGING TECHNOLOGY THAT IS COME OUT. COCAP BRATTING AND PILOT STUDIES, ESPECIALLY IF -- COCALIBRATING AND PILOT STUDIES, AND EVEN ADDING NEW DATA IN WAYS THAT WE NEVER THOUGHT OF AT THIS POINT. >> THE MAIN ASSUMING OF THE WORKING GROUP, IS THAT WE WOULD BE WRONG NO MATTER WHAT WE SAID. BECAUSE THAT'S THE ONLY TRUTH WHEN IT COMES TO TECHNOLOGY ESPECIALLY CONSUMER TECHNOLOGY. YOU'RE WRONG IN A DIFFERENT PACE THAN YOU ARE WHEN IT COMES TO CONSUMER TECHNOLOGY. THIS IS REALLY, A CHALLENGE WE GAVE TO THE NIH LEADERSHIP AND WE SAW THE END RESULTS. IT'S GOING TO BE WRONG. YOU NEED TO MAKE SURE YOU'RE NOT CHOOSING SPECIFIC PLATFORMS. THERE'S AN EXTENSIVE DISCUSSION REGARDING DISPARITIES AND WHO USES WHICH PLAT PLATFORMS. THESE CONSULTANT BE PLATFORM SPECIFIC CHOICES AND DISPARITIES, AND OPENNESS OF THE VARIOUS PLATFORMS OUT THERE TO KNOW THAT THIS, IF IT'S GOVERNMENT INITIATED, HAS TO INCLUDE OPEN KNOW OF A KEY ELEMENT OF THOSE PLATFORMS AND THOSE CRITERIA, DID THE GOOD JOB OF SAYING, HOPEFULLY, THERE IS AN AWARDEE AVAILABLE TO KEEP PACE WITH THIS, KNOWING THAT THE END TECHNOLOGY AND MAYBE THENNED PLATFORM WILL BE DIPLOMAT FIVE YEARS FROM NOW, AND I HOPE DURING THE EVALUATION PROCESS, THERE IS A LACK OF SPECIFICITY REGARDING PLATFORM. CORPORATE AMERICA, PRODUCT PLAN, I THINK ANY OF THE STUFF YOU PLAN FIVE YEARS AGO, AND LET'S ADMIT THAT REALITY. WE'LL BE WRONG SO WE'RE NOT GOING TO STATE WHAT IT SHOULD BE. >> AND I WOULD ADD AT THE SAME TIME WE SAID LOOK, THERE ARE THINGS WE CAN DO ABOUT FRAMEWORK THAT IS REQUIRE, YOU KNOW THE DEVICES AND SOFTWARE THAT ARE USED TO USE STANDARDS WHEN THEY ARE THERE HAVE PARTICULAR OPEN A.P.I.S AND YOU KNOW, THE BIG CHALLENGES, JUST BLACK BOX ALGORITHMS FROM THE CORPORATE ENTITIES THAT DO THIS. IF YOU'RE DEVICE IS GOING TO BE USED IN THESE THINGS, WE NEED ACCESS TO THE RAW DATA BECAUSE IT MAY NEED TO BE PROCESSED IN WAYS THAT YOUR PARTICULAR ALGORITHM IS NOT WHAT WE NEED FOR THE STUDY. SO YOU KNOW, WE CAN PUT IN SOME AT LEAST IN THEORY, MAKE IT EASIER TO ACTUALLY USE THIS DATA FOR RESEARCH PURPOSES, WHICH IS ONE OF THE BIG CHALLENGES EVERYBODY'S HAVING TODAY. IF I PAY FOR T COMING AND GOING AND IT'S ALREADY BEEN PROCESSED THROUGH THEIR BLACK BOX AILING ATH. >> AND I THINK, YOU KNOW THE IMPORTANT THING TO THINK ABOUT THIS COMPONENT OF THE PROGRAM FOCUSING ON THE THINGS WHICH ARE MORE ENDURING AND TO ME, THE BEHAVIORAL SCIENCE IS THE MOST IMPORTANT. I CAN REMEMBER DECISION FOR MICROSOFT DEVELOPING MOBILE SENSORRING DEVICES AND FOR CARDIOVASCULAR PHYSIOLOGY AND THEY WERE DEALING WITH THE ISSUE OF WHAT YOU CAN SENSE IF YOU HAD A SENSOR ON THE RADIAL ARTERY VERSUS THE CAROTID ARTERY. IF YOU THOUGHT OF THAT FROM A PHYSIOLOGY OR TECHNOLOGY STANDPOINT, THE ANSWER IS OBVIOUS, AROUND THE NECK. BUT IF YOU THOUGHT ABOUT THAT, ABOUT THE WAY PEOPLE HAVE FELT NOT FOR THE LAST 10 YEARS BUT PROBABLY FOR THE LAST HUMAN THOUSAN-- HUNDREDTHOUSAND YEARS AROUND THE NECK IS AN ISSUE. >> [SPEAKING AWAY FROM MICROPHONE] -- MOST CLEARLY DEFINED TASKS, WILL BE ABSOLUTELY ACRITICAL ONE, BUT AS I THINK I ADDRESSED AND ANSWER, THE DECISIONS AND LL NOT BE HANDLED BY THEEXAMPLE, BIOBANK, ALTHOUGH IT'LL BE HANDLED BY THE COORDINATING BUT WE ARE EAGER TO HAVE A STATE OF THE ART BIOBANK, WITH SUBSTANTIAL IT'S MEGS. DNA EXTRACK AND POTENTIALLY WHEN WE GET TO BUDGETED THIS AT 35 SPECIMENS PER ENROLLEE, WHEN WE GET TO 35 ALIQUOTS PER ENROLLEE, WHEN WE GET TO AUTOMATED SPECIMEN, WE WILL HAVE A NEED FOR AUTOMATED SPECIMEN RETRIEVAL AT POINT WHERE WE GET TO MAYBE 300,000 ENROLLEES. DIRECT VOLUNTEER, SPECIMEN VALUING. WE RECOGNIZE THAT IT WILL BE ESSENTIAL TO DEVELOP AN EFFECTIVE STRATEGY, TOO PROVIDE A SIMPLE, PHYSICAL EVALUATION AND BIOSPECIMEN COLLECTION, FROM VOLUNTEERS LIVING ANYWHERE IN THE U.S. A NUMBER OF ORGANIZATIONS HAVE TALKED TO US ABOUT POTENTIAL PARTNERSHIPS IN DOING THIS, MODELS OF HOW TO DO THIS HAVE GONE ANYWHERE FROM CV S-BASED MINUTE CLINICS TO BLOOD BANKS TO USE OF LIFE INSURANCE EXAMINERS TO WORKING WITH NETWORKS, OTHER SORT THAT IS DO DISABILITY EVALUATIONS FOR THE FEDERAL GOVERNMENT. SO THERE HAVE BEEN A VARIETY OF IDEAS THAT OF COURSE SENT OUR WAY. RIGHT NOW, WE HAVE ON THE NIH GUIDE, A REQUEST FOR INFORMATION. THERE'S ITS NUMBER. ASKING HOW TO ACHIEVE THIS PART OF THE PROGRAM COST EFFECTIVELY INCLUDING A COST FOR SPECIFICS ESTIMATES. OUR GUESS AT THIS TABLING IS THIS WILL COST US DEPENDING ON WHAT ONE PERFORMS, FROM 150 TO 300,000 -- $300 PER PARTICIPANT. YOU MULTIPLY THAT BY THE NUMBER OF PARTICIPANTS SO WE ARE GOING TO WORK HARD TO FIGURE OUT THE MOST COST EFFECTIVE WAY TO DO THIS. AND WE HAVE ALSO BECOME INCREASINGLY AWARE, AS WE WERE TALKING BRIEFLY IN THE BREAK, THAT THE INTENSITY OF EVALUATION FOR HPO AND TEXT VOLUNTEERS, MAY NEED TO VARY, IF OUR ENROLLEES ARE DEMOGRAPHICALLY SHIFTED IN WAYS THATTEN UP FEELING WE ARE NOT GETTING THE SAMPLE WE NEED. THE PARTS THAT CAN BE DONE COST EFFECTIVELY MAY INCLUDE THE DIRECT VOLUNTEER PARTICIPANT PROVIDED INFORMATION AND EVEN PERHAPS, THE BLUE BUTTON OR FIRE INTERFACE, PROVIDED HEALTH RECORDS. -- THIS IS STILL A WORK IN PROGRESS. WE WILL SUMMARIZE FOR ALL OF YOU, WHAT WE HAVE LEARNED FROM THIS RFIIN A MONTH OR SO. IT IS ON THE STREET RIGHT NOW. HARD TIME KEEPING UP WITH A LOT OF THESE PIECES. BUT IN THE TEXT FROM VOLUNTEER, DO WE GET A PEAK OF SOME OF THE CREATIVE WAYS. AREN'T THE DV GROUPS DOING SAMPLING AND CHECKS? >> SO THE SOLICITATION HAD A CERTAIN AMOUNT OF WIGGLE ROOM IN THAT REGARD, AND THE PRIMARY FOCUS OF THE PILOT WILL BE ON ENGAGING, ENROLLING AND ENGAGING AND NOT ON SAMPLE COLLECTION. WE LEFT OPEN A POSSIBILITY THAT PROPOSERS COULD TELL US SOMETHING ABOUT SALIVA VERSUS BLOOD SAMPLES BUT THAT IS NOT PRO PRESCRIBED IN THE SOLICITATION. FOLLOW WE HAD A BIOBANK, DONE MAKE MUCH SENSE TO DO SPECIMEN CHECK. SO THE DIRECT VOLUNTEER PILOT IS GOING TO TART PRETTY SOON, BUT WE DON'T ANTICIPATE DOING SPECIMEN COLLECTION UNTIL OUR BIOBANK COMES ON BOARD IN JULY. THE TIME OF DATA BEING COLLECTED, THAT'S PRESCRIBED ALREADY. THE EASIEST WAY TO CUT COST IS -- >> NO. THE TYPE OF DATA THAT IS BEING COLLECTED IS NOT YET PRESCRIBED AND WE'RE GOING TO TALK THIS AFTERNOON ABOUT A POTENTIAL PROCESS TO GET INPUT ABOUT THAT. SO IN FACT, ALTHOUGH WE HAVE WRITTEN SOME BROAD SCOPE GUIDELINES AND WORK GROUP REPORT HAD SOME BROAD SUGGESTIONS OF ALL THE TYPES OF DATA OF INTEREST, THE INITIAL CORE, BASELINE ENROLLMENT PROTOCOL IS NOT YET DETERMINED AND I'M GOING TO OUTLINE TO YOU, A PROCESS I'M PROPOSING TO APPROACH THAT, BUT THAT'S REALLY PART OF THE WORK FOR THE NEXT FEW MONTHS. I'M GLAD YOU ASKED. I'M PLANNING TO PUT YOU BACK TO WORK ON THAT. SO THOSE ARE THE RFA'S THAT ARE ON THE TREAT AND THE RFIFOR THE DIRECT VOLUNTEERS. WHAT WE'LL BE TALKING ABOUT IN CLOSED SESSION LATE THIS AFTERNOON AND THEN TOMORROW, ARE THE RESPONSES TO TWO SOLICITATIONS, USING OTHER TRANSACTIONS AUTHORITY. OTHER TRACKS AUTHORITY WILL KIND OF BRIEF YOU ON THE ADVANTAGES OF THIS AS A MECHANISM TO DO WORK SOMEWHAT MORE RAPIDLY, THAN IS CONVENTIONAL, AND WE'LL TALK MORE ABOUT THAT LATER THIS AFTERNOON. BUT THE SOLICITATION WAS WRITTEN WAS WRITTEN WITH THIS BROAD CHARGE. DATA COLLECTION MANAGEMENT AND PARTICIPATION ENGAGEMENT. SET UP A WEBSITE TO ENGAGE POTENTIAL VOLUNTEERS, WORK TO ENGAGE AND OPTIMIZE A PARTICIPANT INTO PHASE WHICH IS SMART PHONE BASED. DID YOU SAY AND CONSIDER POSSIBLE PILOT EXFAMILY MEMBERS AND CREATE SOME DATA STRUCTURES THAT IS SURE THIS PRELIMINARY DATA SET CAN BE CUTER CONNECTED AND SHARED >> THE OTHER SOLICITATION ON THE STREET IS FOR COMMUNICATION COMMUNICATION SETTLEMENT BOTH FOR THE COHORT PROGRAM AND FOR THE PMI INITIATIVE AT LARGE, AS GWEN INDICATED, FOR THE ENTIRE INITIATIVE INCLUDING CANCER PIECE. TO WORK COSILY WITH THE WEBSITE DEVELOPERS, THROUGH THE OTHER SOLICITATION. IT IS TO EVALUATE SOME OF THE COMMUNICATION, DEVELOP COMMUNICATION METRICS AND TELL US -- AND IMPLEMENT WAYS OF VARIETIES, STRATEGIES AND PLATFORMS, AND YOU'LL SEE A FAIR AMOUNT MORE ABOUT THIS. SO OTHER TRANSCRIBING. AUTHORITY ADJUST BRIEF IS DESIGNED TO OBTAIN TECHNOLOGY. IT DIFFERS FROM GRANT AND CONTRACTING MECHANISMS IN THAT IT IS DESIGNED TO FACILITATE EMPLOYMENT OR BRING IF NONTRADITIONAL SOURCES WHO DO NOT ALWAYS RESPOND TO READ THE NIH GUIDE AND RESPOND INTO THE OPPORTUNITIES FOR GRANTS OR CONTRACTS AND TO BE SUBSTANTIALLY MORE MEXIBLE. WE'LL TALK AT SOME DETAIL ABOUT WHAT O.T.A. IS, LATER THIS AFTERNOON. THIS IS THE BROAD STROKES OF THE FUNNELING ANNOUNCEMENTS WE HAVE JUST TALKED TO YOU THROUGH THESE ARE THE VERY -- WE WE ELECTED NOT TO SPECIFY THE BUDGET FOR COMMUNICATION SUSPECT TO,COMMUNE -- COMMUN ICATION SUPPORT. THE COMMUNICATION SUPPORT IS ANTICIPATED A TWO-DREAR AWARD. THE DIRECT VOLUNTEERS ARE ANTICIPATED AS A ONE-CARY AWARD, OVERLAPPING FOR SIX MONTHS, WITH THE PERIOD WHERE THE AWARDS ARE MADE URGE THE FOLLOWING FOR PLUGS WILL -- WHERE THE FOLLOWING 4 PLUGS WILL OCCUR. OH. HERE'S OUR TIMELINE SO WE ARE ANTICIPATING, MAKING THE MAJOR AWARDS FOR THE COORDINATING CENTER. THE HPO'S, BIOBANK AND PARTICIPANT TECHNOLOGY SITES, THE MAKING WILL BE COMING IN TOWARDS THE END OF FEBRUARY AND EARLY MARCH. AND WE'RE ANTICIPATING MAKING THOSE AWARDS BY JULY 1. THE DIRECT VOLUNTEER AND THE OT PHASE, WHICH WE'RE ENTERING IN NOW, WE WILL BE TALKING ABOUT THOSE AWARDS TOMORROW AND HOPE TO MAKE THEM EARLY IN FEBRUARY. ONE PIECE THEY HAVEN'T TALKED ABOUT VERY MUCH, BECAUSE IT'S STILL VERY MUCH A WORK IN PROGRESS, IS A PARTNERSHIP WITH HERSA TO PILOT IN SITE THAT IS SERVE MEDICAID POPULATIONS AND OTHER URGE SERVED POPULATIONS, LARGELY IN INNER CITIES. A SMALL NUMBER OF PILOT SITES TO LEARN MORE ABOUT PARTICIPANT ENGAGEMENT WITH THOSE POPULATIONS WE KNOW ARE JUST RARELY CAPTURED IN OUR RESEARCH PROCESS. THIS IS A PROCESS, GWEN IS LEADING OUR DIALOGUE WITH THIS AREA AND WE HAVE IDENTIFIED A FUNDING MECHANISM FOR CONTRACTS WITH A SMALL NUMBER OF SITES AND ARE WORKING HARD ON DEVELOPING AN APPROACH TO DO THIS AS SOON AS OUR DIRECT VOLUNTEER PARTICIPANT INNER FACE IS READY, WE'RE EAGER TO TRY USING THE SAME WEBSITE AND MATERIALS IN THE SO THING OF FQHC'S AND LEARN HOW TO WORK WITH THE HEALTHCARE PROVIDERS, NURSING, DOCS AND COMMUNITY ENGAGEMENT APPARATUS IN THE SMALL NUMBER OF SITES, SEE WHETHER WHAT WE HAVE WORKS AT ALL OR DOESN'T AND LEARNING A LITTLE BIT TO SEE IF THIS IS A GOOD WAY TO EXPAND THIS RESEARCH. WE HAVE CONCLUDED, BASED ON MENS FROM EVERYONE WHO KNOWS HOW TO WORK IN THIS ENVIRONMENT, THAT SUBSTANTIALLY, MORE INTERPERSONAL TRUSTED INDIVIDUAL INTERACTIONS WILL BE ESSENTIAL TO ENGAGE PEOPLE. SO WE'RE GOING TO TRY TO LEARN A LITTLE MORE IN A SMALL WAY, IN A SMALL SAMPLE OF HOW TO DO THAT, BEFORE WE EXPAND, MAKE DECISIONS ABOUT HOW TO EXPAND THAT ASPECT OF EQUIPMENT. FEDERAL GOVERNMENT RUNS A NUMBER OF HEALTHCARE SETTINGS, INCLUDING THE FQC'S, WHICH HADDING HEALTH CLINICS, AND HEALTH SERVICE CLINICS THAT MAY BE USEFUL AS A WAY FOR STRENGTH AND ENROLLMENT, PERHAPS WE NEED TO WORK WITH CHURCHES THAT SERVE URN SERVED POPULATIONS. PERHAPS WE NEED OTHER STRAIT YEARS THAN HEALTHCARE PROVIDING ORGANIZATIONS TO MEET WHAT WE ALL KNOW IS GOING TO BE A VERY TOUGH CHALLENGE THAT'S THE YELLOW BAR AND THAT'S A WORK IN PROGRESS. BUT ONE WE ARE CONSIDERING AN IMPORTANT PART OF LEARNING HOW TO DO THIS KIND OF WORK. SO I THINK THAT'S MY LAST PRELAUNCH SLIDE. BUT AFTER LUNCH, WE ARE GOING TO TURN TO SOME OF HARD QUESTIONS THAT HAVE ALREADY COME UP DURING THE MORNING LIKE HOW ARE WE GOING TO APPROACH BASELINE PROTOCOL DEVELOPMENT, HOW TO DO THIS AT THE RIGHT SCALE AND THE RIGHT STAGING AND HOW TO DEVELOP A PROCESS FOR CRITICAL POLICY QUESTIONS. SO I'LL LEAD THE FIRST HALF AND CARRIE WILL LEAD THE SECOND HALF OF THAT CONVERSATION. AFTER GETTING YOUR INPUT AND WARNING YOU OF THE WORK TO COME IN BOG OF THOSE SPACES, WE WILL THEN GIVE YOU A KIND OF QUICK BACKGROUND LESSON AND OTHER TRANSACTION AUTHORITY AND THEN L ADJOURN THE OPEN SEGREGATED AND TAKE -- THE OPENSESSION, AN D TALK ABOUT THE CONCRETE RESPONSES AND SOLICITATIONS. SO THAT'S THE PLAN FOR THE REST OF THE DAY. QUESTIONS FOR ME AT THIS POINT? >> WHAT'S THE THIRD ITEM YOU MENTIONED. YOU MENTIONED BASELINE, PROTOCOL, PROTOCOL SCALE. >> OTA. OTHER TRANSACTION AUTHOR. WHAT IT IS, AND WHAT THE REDUCE ARE ABOUT IT AND HOW THE GOVERNMENT USE THIS IS METHOD OF GETTING WORK DONE. IT'S SOMETHING THAT HAS ONLY BEEN USED OCCASIONALLY, THE FAMOUS USES WERE BY DARPA AND SO IT'S UNFAMILIAR FOR THE PEOPLE WHEN WORK FOR THE FEDERAL GOVERNMENT BECAUSE IT'S ONLY USED OCCASIONALLY, SO I FEEL PEOPLE NEED TO HEAR WHAT THE RULES ARE ABOUT IT. >> I THINK YOU GUYS HAVE DONE A GREAT JOB, MAKING THEM JUST THE RIGHT SIZE BECAUSE WE DIDN'T OFFER YOU ANY GUIDANCE IN THAT AREA. YEAH. I THINK YOU GUESSED RIGHT REALLY WELL. >> WELL, WE'LL SEE. THERE WAS DRAFT FOR EIGHT SO LISATATIONS, SO WE TRIED TO TIDY UP BOUNDARIES. I DON'T KNOW IF WE GOT IT QUITE RIGHT. BUT WE'LL LEARN. IT WAS A BIG PART OF THE INITIAL TASK >> I JUST WANT TO OFFER A QUICK INSIDE COMPLIMENT TO THE TEAM. WE WORKED WITH THEM ON A COUPLE OF THE PROVISIONS AND THEY WERE REALLY MASTER FULL. GOOD JOB. DEAN. >> DO YOU HAVE A SENSE -- >> YEAH, READ THE RS PHASE. T WE'RE KIND OF PROUD OF THEM. NOT THAT THEY'RE PERFECT. >> THE ONLY CONCERN I WOULD HAVE IS THE DATA COORDINATING CENTER, AND THE BIOBANK, YOU KNOW, HAVE CUSTOMERS, WHICH ARE ACTUALLY THE PARTICIPANTS, BUT WE PUT THE H.P.O.S AND OTHER THINGS IN BETWEEN THEM AND I THINK THATON IS OKAY BE CAUSE ACTUALLY, IT'S A DIVERSITY OF OPINION IS ONE WAY TO THINK OF IT. BUT MAKING SURE THAT WE IDENTIFY THE RULES AND RESPONSIBILITIES. YOU ARE WISE ENOUGH TO MAKE SOMEBODY THIS FAR AWAY, FROM THE END CONSUMER, BUT WE HAVE MOVED IT ONE STEP OUT. BY STILL PUTTING THEM IN BETWEEN. I THINK PRODUCTS. THESE ARE MINIMAL, VIABLE PRODUCTS. WE HAVE TO GET OUT THERE, ITERATE, WITH A VISION AND THAT ITERATIVE PROCESS REALLY ASSUMES THE END PARTICIPANT, NOT JUST IN THE ENGAGED BUT THAT THE ENTITY MAKING THOSE CHOICES IS TOUCHING THAT PARTICIPANT WITHOUT AN INTERMEDIARY. WITHOUT A FILTERING OF OPINION AND A FILTERING OF VOICE TO SAY, IT'S TOO HARD TO CONNECT THAT BLOOD. THAT PARTNER MAY BE THE NURSE, PHYSICIAN, WHOEVER IT IS, THAT'S WHICH I RECOLLECTING THAT SAMPLE. YOU'RE SUDDENNING THE DATA BACK OUT -- YOU'RE SUDDENNING THAT DATA BACK OUT -- YOU'RE SENDING THAT DATA BACK OUT. THE DIRECT INTERACTION WITH THE END VARIETY OF CUSTOMERS >> I HAVE THOUGHT IT IS ABSOLUTELY ESSENTIAL THAT THIS PROGRAM HAVE DIRECT CONTACT WITH THE PARTICIPANTS. THAT WHILE THE H.P.O.S ARE IMPORTANT PARTNERS HERE, WE CAN'T LET THEM BE THE FILTERS FOR OUR ENGAGEMENT WITH THE PARTICIPANT. THAT'S WHY WE ELECTED NOT TO BUILD THIS COHORT OUT OF LEGACY COHORTS THAT THE H.P.O.S ALREADY HAD. AND WE HAVE TO DO THIS WITH ATTENTION TO INSENSITIVITIES, THESE ARE THEIR PATIENTS BUT THINK IF YOU HAVE A LARGE HEALTHCARE SYSTEM. GROUP HEALTH. NOW, KAISER NUMBER TWO, NORTHWEST WE DO NEED TO BE SENSI TO THE FACT THAT THEY ARE THE ORGANIZE PROVIDING HEALTHCARE TO THAT ORGANIZE [ [PHONE MUSIC] >> I CAN SEE DEVICES ARE EVERYONE. I THINK WE HAVE TO BUILD A STRUCTURE WHERE THERE IS A DIRECT ABILITY TO CAPTURE THE VOICE, AND THAT IS GOING TO CAPTURE A NEGOTIATION THAT HAS TO BE ATTENTIVE TO THE SENSITIVITY THAT IS GO INTO IT AND HOPEFULLY, WEEK HAVE THAT >> AND I THINK, IT'S A BROADER DISCUSSION, NOT JUST HEALTHCARE PROVIDER ORGANIZES BUT SOME OTHER ORGANIZES, YOU KNOW WHEN, WE'RE WORKING THROUGH GATE KEEPERS WHEN IS A GATE KEEPER REALLY SERVING THE INTEREST OF THOSE THEY WOULD THINK THAT THEY SERVE AND WHEN IS THE GATE INTERESTS AND THERE'S SOME IMPORTANT ECT CAL ISSUES ABOUT GATE KEEPER CONTROL THAT WE NEED TO BE THINKING ABOUT. >> OKAY. I THINK IT'S A GOOD POINT FOR A BREAK. AND THE CAFETERIA IS DOWN ON THE FIRST FLOOR. HAS ANYONE ELSE I DON'T UNDERSTAND ON THE PHONE? MIKE IS THERE. I THINK ERIC DISHMAN. ANYONE ELSE ON THE PHONE AT THIS POINT? I THINK WE HEARD ONE PING AT LEAST >> YEAH, ROB CARLIF. SHORT TRIP, SORRY I COULDN'T GET OVER THERE. BUT THERE WASALLY MESSINESS OVER AT THE FDA >> YOUR WELCOME AND WAY CAN YOU JOIN US AND WE'LL CERTAINLY MAKE SURE YOU HEAR A SYNOPSIS OF EVERYTHING HAPPENING HERE. >> RIGHT. THANKS. OKAY. SO WE ARE GOING TO BREAK UNTIL 1:00. AND GET BACK TO WORK AT THAT POINT. THANK YOU. PERHAPS OVERLY OPTIMISTIC. AND SO THAT'S ALL UNDERSTANDABLE. ALL VERY BUSY BUT WE WANT TO HIT SOME OF THE AREAS WHERE THERE ISN'T CLARITY ON WHO'S DOING WHAT. PROBABLY THE BIGGEST IS THAT THERE SEEMS TO BE A LACK OF CLARITY ON WHERE THE BILL COSTS FOR THE DIRECT VOLUNTEER PHYSICAL EVALUATION WILL BE HANDLE AND WE WANT TO CORRECT THAT BUT THERE ARE A FEW OTHERS THAT ARE CLEARLY AMBIGUOUS FROM THE QUESTIONS WE GOT. WE'RE GOING TO PUT TOGETHER A DOCUMENT. WE PUT IT IN GUIDE. WE HAVE SENT PEOPLE WHO ASKED US QUESTIONS A NOTE THAT THERE'S A CLARIFICATION AND I THINK WE HAVE PRETTY GOOD STRATEGIES AND MECHANISMS TO CORRECT THOSE THAT ARE NOT FULLY WELL UNDERSTOOD. KATHY, WELCOME >> THANK YOU. AS YOU ALL KNOW, KATHY HAS BEEN LEADING THE DIALOGUE, THE ACD WORKING GROUP AND WAS ONE OF THE CHAIRS IN IT, AND IS IN MANY WAYS, THE MASTER MIND BEHIND ALL THESE COMPLEXITIES KATHY AND I ARE WORKING HARD ON THE MANY COMPLEXITIES OF IMPLEMENTATION. WE HAD A VERY GOOD DISCUSSION THIS MORNING, AND I THINK PEOPLE ARE FEELING, HAVE RAISED SOME OF GOOD AND HARD QUESTIONS AND WE'RE ABOUT TO TALK NOW ABOUT THE NEXT SET OF TASKS, AND THIS AFTERNOON IN CLOSED SESSION, WE'LL BEGIN THIS PROCESS OF APPROACHING DECISION MAKING ABOUT THE APPLICATIONS THAT ARE ALREADY. SO I WANT TO LAYOUT WHERE WE ARE ON THIS WORK TO DO AND IN PARTICULAR CHAPTER OF THE WORK TO DO IS THE DEVELOPMENT OF THE BASELINE CORE PROTOCOL. SO HERE WE ARE. SECOND WEEK IN JANUARY, AND I AM MOST PARTICULARLY, WORRY GOING YEAR ONE. I WANTED TO DELINEATE SOME OF THE TASKS I SEE OCCURRING IN YEAR ONE, NOT THAT THERE AREN'T IMPORTANT LONG-TERM TASKS AS WELL, BUT THESE HAVE A PARTICULAR URGENCY. JULY 1, WE MAKE TO MAKE THE AWARDS FOR THE BIOBANK AND PARTICIPANT TECHNOLOGIES, ALL OF THESE, WE TALKED ABOUT THIS MORNING. RIGHT NOW, WE'RE AT THE POINT OF APPROACHING, MAKING AWARDS FOR A VOLUNTEER PILOT AND COMMUNICATION AWARDS. BUT WE ARE AIMING VERY AMBITIOUSLY FOR LONGITUDINAL COHORT STUDY TO BEGIN SOME PORTION OF DIRECT VOLUNTEER AND HPOENOLEMENT IN THE FALL. AND I THINK MANY MUCH YOU HAVE BEEN INVOLVED IN STUDIES LIKE THIS AND KNOW THIS IS A FASTER TIMELINE THAN NORMALLY OCCURS I LIKE TO BOAST, I DON'T THINK THE NIH HAS EVER BEEN, ISSUED A SOLICITATION IN NOVEMBER RECEIVED THE APPLICATIONS A MONTH LATER AT CHRISTMAS, REVIEWED THEM EARLY IN JANUARY IN PREPARING TO MAKE WORDS AT THE END OF JANUARY. SO WE ARE MOVING FASTER, BY GOVERNMENT STANDARDS, LET ME TELL YOU, THIS IS LIGHTNING. I FEEL PRETTY CONFIDENT WITH THE PROCESS, THE INTEREST, BASED IN PART, BECAUSE PEOPLE OF COURSE TALKING ABOUT THIS FOR A COUPLE YEARS ON WHAT WE GOT AND WHAT WE'RE GOING TO BE SHOWING YOU TOMORROW MORNING, IN TERMS OF OUR FIRST AWARDEES. BUT I'M VERY WORRIED NOW, ABOUT GETTING THE RIGHT THINKING THE RIGHT BALANCE ON ORGANIZATION AND PARTICIPANT LAUNCHED HERE, TO MAKE IT REALISTIC THAT SOME PART OF THE ENROLLMENT, BASED ON ENROLLMENT CAN BE READY FOR ACTUAL IMPLEMENTAT IN THE FALL. YOU'RE GOING TO HEAR THROUGHOUT THIS CONVERSATION, JOSE'S BIAS, WHICH IS KEEP IT SIMPLE. NOW, I'VE BEEN INVOLVED IN BIG STUDIES BEFORE AND I'VE ALSO BEEN ONE OF THOSE VOICES THAT SAID, OH, IT WOULD BE TERRIBLE THIS STAGE TO ADD THIS AND THIS AND THIS, AND THERE OF COURSE PART OF PROJECTS THAT ENDED UP PUTTING QUESTIONNAIRE STACKS WHEN WE LAUNCHED A CHRONIC WE FELT AT THE START, WE HAD TO CAPTURE LOTS OF THINGS ABOUT PEOPLE. IN RETROSPECT, A LOT OF THAT DATA NEVER ENDED UP USED AND ALSO, I'VE BECOME AWARE IN THE OCCASIONAL STUDY WHERE I'VE BEEN A VOLUNTEER, THAT WHEN PEOPLE ASK YOU 312 QUESTIONS, YOUR PATIENCE WEANS, AND YOU'VE HEARD A FAIR AMOUNT OF DISCUSSION THIS MORNING AND HOW THIS IS GOING TO DIFFERENT. IT'S GOING TO BE A PROCESS IN WHICH WE HAVE QUESTIONS REPEATEDLY, IN SMALL BITE SIZED PIECES, AS PARTICIPANTS LEARN WHICH QUESTIONS ARE FUN TO ANSWER. WHICH QUESTIONS CREATE QUESTIONS BACK TO THE PARTICIPANT, WHICH KEEPS THEM ENGAGED SO A BIG PART OF OUR PROTOCOL HAS TO BE WHAT HELPS US ENGAGE PEOPLE AND KEEP THEM PART OF IT PEOPLE TALK ABOUT THE PHRASE, "PARTICIPANT BURDEN" AND KATHY KIND OF I THINK RIELY CROSSED THAT OUT IN THE DOCUMENT. I SAID WE DON'T WANT BURDENING OUR PARTICIPANTS. WE WANT EVERYTHING IN THIS TO BE ENGAGING AND THAT IS THE VISION BUT IT'S GOING TO BE CHALLENGING TO ACTUALLY IMPLEMENT WE HAVE THIS MANDATE, SO I'M GOING TO ASK YOU FOR A LOT OF HELP IN HOW WHEY THINK ABOUT WHAT WE CAN COLLECT AND WHAT WE WILL MEASURE. I KNOW FROM THE CONVERSATIONS WE ALREADY STARTED HAVING HERE AT THE NIH, WE HAVE HAD A FAIRLY ACTIVE GROUP WORKING ON DIFFERENT PARTICIPANT PROVIDED INFORMATION AND WE BRING IN PEOPLE WHO RUN STUDIES IN DIFFERENT AREAS FROM DIFFERENT NIHIC'S AND WE ARE IMMEDIATELY TOLD BOY, THAT WOULD BE TRAGIC IF YOU DON'T CAPTURE ALL THE ELEMENTS RELEVANT TO DRUG ABUSE OR ALL THE ELEMENTS RELEVANT. ENGAGED AND HOW TO MAKE A LEAN, INTELLIGENT START, WITHOUT ACTIVELY CREATING SOMETHING THAT FIT THAT IS NAME PARTICIPANT BURDEN BUT IN FACT, IS PARTICIPANT ENGAGEMENT. >> SO HAVE WE HAD ANY PARTICIPANTS BEING A PART OF THOSE WORKING GROUPS YET? >> WELL, THE ONLY ONE THAT EXISTS IS A GROUP THAT PULL TOGETHER THE PAIDED INFORMATION FROM THE MILLION VETS AND BIOBANK AND THREE OTHER LARGE COHORT STUDIES AND COMPARED THE -- SHARON WAS PART OF THAT, AND THAT'S THE ONLY ONE THAT HAS ACTUALLY STARTE. THE OTHER PIECES ARE STILL IN. WE HAVE HAD SOME INTERNAL DISCUSSION, BUT NO REAL CENTRAL AMERICAS YET. >> I'M GLAD TO HEAR SHARON. THANK YOU >> AND NOTE, THIS IS ONE THAT NOW NEEDS TO -- THAT WAS ACTUALLY GOING ON EVEN BEFORE WE WROTE THE RFA'S, AND WE NOW ARE GOING TO HAVE TO MOVE AND MATURE IT TO A PROCESS. SO I'M GOING TO SHOW YOU HOW I PROPOSE TO DO THIS. SO HERE'S THE CORE PRINTS INVOLVED. BASED ON PROTOCOL, WILL BE DEVELOP COOPERATIVELY WITH THE STEERING COMMITTEE AND THE PME. BITE STEERING COMMIT AND THE PMIPROGRAM COHORT DIRECTOR, WITH ADVICE AND INPUT FROM YOU, THE ADVISORY PANEL AND FROM THE PROGRAM STAFF. THIS IS THE BEGINNING OF A CONSULTIVE PROCESS. WE NEED TO DEVELOP, USE OUR RESOURCES TO FIND THE ELEMENTS OF MAXIMUM VALUE, BOTH TO PARTICIPANTS AND RESEARCHERS. WE NEED TO INTERACT REGULARLY, THROUGHOUT THE ENTIRE PROCESS, WITH PARTICIPANTS AND LEARN WHAT INTEREST PARTICIPANTS CARE ABOUT AND MAINTAIN ENGAGEMENTS. AND YOU'VE JUST HEARD ME SAY THAT I THINK IT IS REALLY IMPORTANT THAT THIS BASELINE ENROLLMENT PROTOCOL BE AS SIMPLE. MEASURE OF INTEREST TO PARTICIPANTS AND WILL IT HELP INCREASE ENGAGEMENT IS THE MEASURE, PERHAPS FOR SUBGROUP DEVELOPMENT OR IMPLEMENTATION. NOW THERE ARE OTHER THINGS THAT COME INTO THIS. THAT SHOULD HELP CROSS WALKING DATA WITH OTHER LARGE COHORTS, IS IT GOING TO BE SIMPLE TO IMPLEMENT AND FOR ITERH ELEMENTS, ARE THEY VARIABLES THAT ARE CONSISTENTLY DEFINED AND CAN BE REASONABLY EFFECTIVELY INTEGRATED. ONE PIECE OF THIS AS JOHN AND I HAVE ALREADY BEEN TALKING ABOUT, WILL BE WHAT ARE THE BEST PIECINGS OF HEALTH I.T. DATA TO START WITH, AND WE ALL RECOGNIZE THAT OVER THE NEXT FEW YEARS, THE CAPACITIES OF HEALTH ID DATA TO ENRICH THIS ARE GOING TO GROW, BUT WE WANT TO TART WITH THE CORE SET OF VARIABLES WE'LL START WITH THE BASIC DATA STRUCTURES, BUT WE. LEADERSHIPS LIKE MEDICATIONS OR OTHERS THAT ARE REASONABLY WELL STANDARDIZED OR THAT ARE GOING TO WORK FOR THE BLUE BUTTON OR EMERGING FIRE STANDARDS. AND THE ELECTRONIC HEALTH RECORDS, INCLUDING NATURAL LANGUAGE OF PROCESSING, THAT MAY NOT BE THE PLACES WE WANT TO START. I AM FOLK FOCUSING. NOT ON THE ENTIRE YEAR, BUT WHAT WE SHOULD BE DOING OVER NEXT FOUR, FIVE MONTHS UNTIL WE MAKE THESE AWARDS. SO HERE'S A PROCESS I WANT TO PRO TO YOU AND I WANT YOU TO TELL ME WHAT YOU THINK ABOUT THIS PROCESS AND WHETHER WE GOT IT ABOUT RIGHT. THE FIRST PHASE IS A CONVERSATION ON WHAT ARE SOME BACKGROUND INFORMATION THAT CAN INFORM THAT. THE KNOWLEDGE AND THE BACKGROUND DOCUMENTS WOULD IN PHASE TWO -- EACH PHASE COULD POTENTIALLY ENGAGE PARTICIPANTS BUT IN PHASE TWO IS THE WHERE I HOPE TO REALLY BROADEN OUR INPUT AND HAVE A DOCUMENT AND PERHAPS AN ONLINE FORUM, PERHAPS SOME FOCUS GROUPS, A TRUE PROCESS THAT GETS A BROADER MORE REPRESENTATIVE CAPTURE. AND EACH OF THESE PHASES, THE BACKGROUND DOCUMENTS, I ANTICIPATE YOU FOLKS LOOKING TO READ AND LOOK AT AND THEN THE INPUT WE GET IN PHASE 2, I EXPECT YOU TO LOOK AT AND THE BACKGROUND DOCUMENTS, AND COMING UP WITH A SET OF PAPERS THAT SUMMARIZE WHAT WE HAVE LEARNED THROUGH THAT PROCESS. NOW, THERE'S ONE MATTER HERE, WHICH WAS ALREADY TALKED ABOUT. WE DON'T WANT THE OVERALL EVOLUTION OF THE PROTOCOL HAS TO BE ONE, THESE WILL BE COOPERATIVE AGREEMENTS. WE WANT TO HAVE ONE HOMEWORK DONE -- ENOUGH HOMEWORK DONE, REASONABLY RAPID START, WITHOUT BEING TOO HEAVY HANDED AND MOVING INTO DECISIONAL TOPICS WHERE OUR AWARDEES NEED TO BE INVOLVED. AND THAT'S ANOTHER AREA I'M GOING TO TURN TO YOU FOR ADVICE. ARE WE GETTING THAT RIGHT AND EACH OF THESE BACKGROUND PAPERS WILL BE PHRASED, PERHAPS SLIGHTLY DIFFERENTLY. BIOSPECIMENS. HOW LONG WILL THEY SIT BEFORE THEY'RE CENTRIFUGED, MAY NOT BE A LOT OF. WE JUST LEARNED WHAT OCCUR IN BEST PRACTICES. THE COMPLEXITYINGS OF WHAT'S DOWNLOADABLE CURRENTLY FROM THE COMMON SYSTEMS BY HPOIS MAYBE A PRETTY TECHNICAL QUESTION. BUT THERE ARE A LOT OF DOMAINS THAT WILL HAVE MORE COMPLEX DECISIONS STILL TO BE MADE, EVEN AFTER WE PULL TOGETHER SOME THINKING. SO WE HAVE TO KIND OF GET THAT JUST ABOUT RIGHT. NOT TOO PRESENTIVE, BUT THOUGHT THROUGH ENOUGH TO BE HELPFUL TO THE STEERING COMMITTEE AND PERMANENT DIRECTOR. I'M HOPING THAT WHEN THE REALLY HARD DECISIONS HAVE TO BE MADE, SOMEBODY ELSE IS SITTING IN THIS CHAIR. BUT ANY WAY, WE'RE WORKING HARD ON THAT. BUT I THINK AT LEAST THINKING ABOUT WHAT BACKGROUNDS YOU NEED TO KNOW. PULL TOGETHER TOGETHER, AND SUMMARIZING THE KIND OF CRITICAL QUESTIONS IS STEP ONE. A BROAD MECHANISM FOR INPUT IS STEP 2, AND SOME ADVICE OF RECOMMENDATION SYSTEM PHASE THREE. AND I HOPE YOU ARE KIND OF READING INTO THIS THAT YOUR NAMES ARE GOING TO HELP POPULATE THIS PROCESS AND I WANT THE ADVISORY PANEL TO HAVE SEEN EVERY BACKGROUND DOCUMENT WE HAVE DEVELOPED TO SEE SOME KIND OF SENSIBLE HARE OF THE INPUT WE HAVE GOTTEN, AND TO BE VERY MUCH PART OF THE FORMULATION OF THE FINAL PHASE III. SO THAT'S PROCESS. I'M GOING TO AMPLIFY THIS A BIT. ONE THING THAT WE HAVE ALL REALIZED, AS WE THINK ABOUT THIS IS OUR CORE PRINCIPLES THAT YOU SAW ARTICULATED SO WELL IN THE ADVISORY REPORT OF THE WORKING GROUP, WILL NEED TO BE A KIND OF CORE ZUCK HERE. SO THAT WHEN PEOPLE RESPOND TO THIS, THEY UNDERSTAND THE CORE PRINCIPLES AND HOW WE'RE GOING TO EXTRACT THAT FROM WHAT'S ALREADY BEEN WRITTEN. HOW WE'RE GOING TO TALK ABOUT THAT AND DO OUR BEST TO ENSURE THIS INPUT OCCURS ON THE BACKGROUND OF A CLEAR STATEMENT OF THOSE CORE PRINCIPLES WILL BE ANOTHER CHALLENGE THAT WE HAVE GOT TO WORK ON. >> CAN I MAKE A SUGGESTION THAT WE ALSO MAYBE ADD SOME OF THE IN HOUSE OR TECH GROUPS IN PHASE TWO BECAUSE I THINK WE NEED TO BRING TOGETHER, NOT ONLY THE PARTICIPATE RESEARCH BUT I WANT TO KNOW WHAT COOL THINGS WE CAN DO WITH THE DATA, AS WE'RE EVALUATING. I FEEL LIKE WE NEED SOMEBODY TO SAY, I NEED THIS TYPE OF DATA TO DO THESE BENCH MARKING. >> OPTIMISTIC DIRECT VOLUNTEER PILOT IS GOING TO HELP US IN A WAY, POPULATE. BUT I TOTALLY AGREE BUT WHEN YOU SEE MY TOPICS, YOU'LL REALIZE THAT I AM A LITTLE CAUTIOUS. I AM TALKING ABOUT A PROCESS BETWEEN NOW AND JULY. AND SOME OF THE END HEALTH PIECE AND SOME OF THAT HAVE PROCESS HAS TO KEEP GOING. SO JOSE'S IMMEDIATE WORRY IS GETTING ENOUGH HOMEWORK DONE THAT AT THE TIME WE HAVE THESE AWARDEES IN PLACE, WE CAN ENSURE PRETTY RAPID MOVEMENT FROM THERE. YOU ARE ALSO RAISING THE VERY IMPORTANT QUESTION OF WHAT ARE THE MOST IMPORTANT FIRST USES AND I THINK THAT'S AN IMPORTANT SET OF QUESTIONS, ONE THAT I HAVE TO ADMIT AS WE THINK WHAT WILL BE THROUGHOUT FIRST DATA SETS GENERATED, THEN THE QUESTION OF WHAT WILL BE THE FIRST USES WILL ALSO START TO CRYSTALLIZE. THE DIRECT VOLUNTEER PILOTS WILL CREATE SOME DATA THAT WAS USABLE FOR SOME OF THE QUESTIONS YOU'RE RAISING BUT I THINK WE DO NEED TO CRYSTALLIZE OR CATALYZE A DIALOGUE WHAT ARE THE EARLY USES AND WE'RE NOT AS FAR ON THAT AS I WISH WE WERE. SO THAT'S WHAT WE ARE TALKING ABOUT. SO I AM PROPOSING AT THIS POINT, BUT I REALLY WELCOME YOUR HELP. SIX TOPIC AREAS, WE HAVE ALREADY TALKED ABOUT THIS MORNING, THIS SORT OF QUESTION OF HOW DO YOU BREAK UP BOXES, ENDS UP COMPLEX IN A PROJECT OF THIS SIZE. BUT I'M PROPOSING SIX BOXES AND I'M GOING TO SHOW YOU THOSE BECOMES QUICKLY. AND THEN GET YOUR INPUT AS TOHETHER WE HAV E GOT SOME RIGHT. I WILL TURN WHAT WE ARE TALKING ABOUT TOGETHER INTO A PROCESS OF PROTOCOL DEVELOPMENT PAPER THAT WILL DESCRIBE THE PROCESS THAT WE'RE UNDERTAKING. YOU'LL THEN BE ASKED TO BLESS THAT OR TWEAK IT OR CHANGE IT OR VETO IT AND TOTALLY TURN IT UPSIDE DOWN. BUT WHATEVER. WE ARE TRYING TO EVOLVE A PROCESS HERE THAT WILL ENSURE THAT WE CAN MOVE FORWARD OVER THE NEXT FOUR ENVELOPE MONTHS, TOO USE YOUR ADVICE WELL AND TO FACILITATE THE PROCESSES THAT THE STEERING COMMITTEE AND PERMANENT DIRECTOR WILL HAVE TO LAUNCH AND I HOPE OUR VOLUNTEER AWARDEE AND COMMUNICATIONS AWARDEE WILL BE A VERY MUCH PART OF THE SUPPORTS FOR WHAT WE'RE DOING OVER THE NEXT FEW MONTHS. THIS IS JOSE'S PROPOSED TOPIC ONE. WHAT IS THE CORE INFORMATION TO BE PROVIDED BY ALL PARTICIPANTS CONSIDERED ENROLLED IN THE COHORT. WHAT ARE ADDITIONAL MAJOR DOMAINS FOR POSITIONS, PROVIDED INFORMATION. AND WHAT ARE CRITICAL ELEMENTS CAPTURED IN EACH DOMAIN IN THE INITIAL ENROLLMENT PHASE. NOW, THIS IS BACK TO THIS IDEA THAT WE'RE GOING TO DO THIS PIECEMEAL, THAT WE'RE GOING TO BE COMING BACK TO PEOPLE WITH MORE DETAILED INFORMATION. MAYBE WE START WITH FIST QUESTIONS AND THEN WE GO BACK TO THEM AT INTERVALS WITH FIVE QUESTIONS AT A TIME AND SOME OF THAT, WE CAN LEARN FROM THE DIRECT VOLUNTEERS PART OF THIS WILL BE ADDITIONAL CORE INFORMATION WHICH WILL ONLY BE A SUBGROUP OF OUR ENROLLEES, AND A SIZEABLE SUBGROUP IN THE ENROLLMENT PHASE. CHAPTER 1. CHAPTER TWO. THAT SHOULD BE THE COMPONENTS. AND AN PERSONALITY QUESTION IS THE PROCESS TO DO THIS AND WE ARE CERTAINLY GOING TO LEARN THIS. I MENTIONED THE RFIWE HAD ABOUT THE PHYSICAL VALUING CAPABILITIES FOR DIRECT VOLUNTEERS. HOW MIGHT IT DIFFER. ARE THERE WAYS IN WHICH AN A.P.O.-BASED PHYSICAL EVALUATION WOULD HAVE SOME COMPONENTS THAT MIGHT BE HARD TO IMPLEMENT FOR DIRECT VOLUNTEERS OR SHOULD WE TRY TO KEEP IT SIMPLE AND SANE EVERYONE. AND FLUSHING OUT, LEARNING WHAT ARE THE COMPONENTS THAT HAVE BEEN USED IN OTHER STUDIES, GINA WAY AND I WERE JUST TALKING ABOUT THIS, HEART LUNG AND BLOOD RUNS A NUMBER OF LONGITUDINAL COHORT STUDIES. SOME OF TEMHAVE PRETTY BRIEF EVALUATIONS. SOME OF OUR THEM HAVE A WHOLE DAY COMPLEX EVALUATION. WE'RE DELIGHTED TO MAKE WITH US.>> DELIGHT ED TO BE HERE AND I WAS MEETING WITH SECRETARY MCDONALD THIS MORNING WHO SENDS HIS REGARDS. >> GOOD, SO I THINK, MIKE MAY EXPAND ON THIS INTRODUCTION, BUT AS MOST OF YOU KNOW, HE'S KEY LEADER OF THE PROGRAM IN THE V.A. CHAPTER THREE. PARTS OF IT ARE AND PARTS OF IT AREN'T. THE CHECKED PROTOCOL, THE PARAMETERS AROUND SPECIMEN HANDLING, BUT THEN THE BROAD QUESTION, WHAT SPECIMENS SHOULD BE COLLECTED, HOW SHOULD THEY BE PROCESSED, WHAT ACCOMMODATIONS IN THE CHECKEDS PROTOCOL ARE APPROPRIATE FOR DIRECT VOLUNTEER ENROLLEES. AND A VERY IMPORTANT CHAPTER WILL BE AROUND ELECTRONIC HEALTH RECORDS. CORE DATA ELEMENTS TO BE EXTRACTED INITIALLY. SOME OF THIS MAY INVOLVE SOME TECHNICAL SPECIFICATIONS THAT GET DEVELOPED IN COOPERATION WITH OTHER ECT PERIOD OF TIMES IN THE FEDERAL GOVERNMENT BUT WE HAVE TO CONSIDER VIABLE FOR OUR MAJOR HEALTHCARE PROVIDER ORGANIZATION AND RELEVANT HERE ARE THE DATA ELEMEN THAT WILL BE AVAILABLE. YOU'VE HEARD BLUE BUTTON OR ANOTHER THING THAT'S BEING MENTIONED, A PROCESS TO EXPAND OUR BLUE BUTTON. GENETIC MEASURES AND LAB TESTS, WHAT SHOULD BE MEASURED INITIALLY AND ISSUES AROUND ENROLLMENT OF FAMILY MEMBERS. WHAT WERE THE KEY ISSUES THAT NEED TO BE CONSIDERED IN EXPANDING ENROLLMENT TO FAMILY MEMBERS WHAT I'M PROPOSING IS SIX CHAPTERS IN WHAT I'M CALLING PROTOCOL DEVELOPMENT. TERRY WILL BEGIN TALKING ABOUT THE CHAPTERS, THERE ARE A LOT OF POLICY ISSUES AND TERRY WILL BE LEADING THAT PART OF THE PROCESS AND I'VE TRIED FOR THE PURPOSE OF THIS DEVELOPMENT OVER THE NEXT FEW MONTHS, TOO SEPARATE PROTOCOL DEVELOPMENT FROM POLICY DEVELOPMENT BECAUSE I THINK THAT IS A SPRAYING, BY AND LARGE, CAN BE MAD -- THAT IS A I THINK THAT IS SEPARATING BY AND LARGE. AND WILL IMPACT ON ALL ELEMENTS OF THIS. SO AT THIS POINT, I AMED TO HEAR FROM YOU, HOW YOU THINK ABOUT OUR PROCESS, WHAT ARE THINGS WE ADD TO IT AND WHAT ARE QUESTIONS THAT COME TO YOUR EXPERIENCED MINDS AS WE TALK ABOUT THIS. YEAH. GREG. >> NOT GETTING INTO DETAILS BUT WHAT I WAS WRITING DOWN, TOO ME, SORT OF TWO PRINCIPLES OR IDEAS TO HOLD IN MIND. I THINK WE HOPE THIS WILL BE A FUNDAMENTALLY DISCORRUPTIVE ACTIVITY. IN TWO WAYS IN WHICH I HOPE IT IS DISRUPTIVE, ONE IS, I THINK WE WANT TO AVOID THE NATURAL TO REPROVE WHAT WE ALREADY KNOW. SO WHEN WE TALK ABOUT MEASURES, I THINK MANY OF US WOULD MEDICAL JUMP TO THE MEASURES WHICH WOULD ALLOW US TO REPEATEDLY DEMONSTRATE THAT WHICH IS KNOWN. SO TO PICK ON MY OWN AREA, I THINK OUR QUESTION WOULD NOT BE FOR INSTANCE, ADVERSE CHILDHOOD EXPERIENCES ASSOCIATED WITH AN INCREASED RISK OF MOOD DISORDER. WE WANT TON WHY ARE THEY SOMETIMES AND NOT ON OTHER TIMES. THIS IS ALL ABOUT INTERACTION KNOW ABOUT WHAT ARE THE DIFFERENT MEASURES THAT WILL ALLOWS TO DISSECT AND MOVE BEYOND THE MAIN EFFECT. ANOTHER POINT, ALREADY A LOT OF THIS IN THE ORGANIZATIONAL STRUCTURE. I THINK IT'S IMPORTANT TO KEEP IS TO BREAK UP WHAT I SOMETIMES IN MY PROVOCATIVE MOMENTS, REFER TO AS THE INTROVERTED RESEARCH OF THE CARTEL ENTERPRISE. A RESEARCH ENTERPRISE INVOLVES A SINGLE ORGANIZATION, MANAGING ALL PHASES OF ACTIVITY, RANGING FROM ITS RELATIONSHIPS, TECHNICAL DECISIONS, THE MANAGEMENT ANALYSIS OF DATA AND DISSEMINATION OF THOSE RESULTS AND THERE'S RARELY A GROUP THAT'S THE BEST IN THE WORLD OF ALL THOSE THINGS. WHAT WE'RE TALKING ABOUT HERE, IS REALLY BREAKING THAT UP AND SAYING WE NEED TO MAKE SURE THAT THE PEOPLE WHO REALLY, YOU KNOW, CAN MAKE THE BEST DECISIONS ARE MAKING THE DECISIONS AT THAT LEVEL AND THIS STRUCTURE YOU'RE TRUCKING ABOUT, ALLOWING OPPORTUNITY TO BREAK APART THAT USUAL INTEGRATION >> I LOVE THAT COMMENT AND I'M REALLY EAGER TO HEAR AND CONTINUED THOUGHTS ABOUT HOW TO ACTUALLY IMPLEMENT THIS. IN THE DISCUSSIONS OF THE WORKING GROUP, THERE WERE PEOPLE POINTING OUT. SO FIRST OF ALL, A MILLION IS A VERY LARGE NUMBER. AND WE DO NOT KNEE OR HAVE TO, GET ALL THE INFORMATION ON A MILLION PEOPLE. WE NEED TO MAKE SURE THAT WE HAVE CREATE CREATED A STRUCTURE THAT ALLOWS THE FORMULATION OF THE APPROPRIATE SIZED GROUPS TO ANSWER ANYTHING QUESTIONS THAT CAN'T BE DONE CURRENTLY. MAYBE YOU NEED ONLY 20,000 PEOPLE TO DO THAT. SO AS IMPORTANT AND INTERESTING THE QUESTION IS MAYBE THE WAY WE NEED TO THINK ABOUT THIS IS WILL OUR BASELINE CORE ALLOW YOU TO IDENTIFY A SIMPLE THAT WILL ALLOW THAT KIND OF STUDY AND APPROPRIATE DEPTH. WHY DO WE HAVE SUCH AN INNER CITY PREPONDERANCE OF THE EVIDENCE OF CHRONIC KIDNEY DISEASE. AND I KNOW HOW HARD IT WOULD BE TO DEVELOP A -- HOW EBBING PENSIVE IT WOULD BE TO DEVELOP AN INNERCITY COHORT TO ANSWER THAT. FROM A MILLION PEOPLE, WHO COULD VERY EFFECTIVELY THINKER CHOOSE 20,000, WITH A ZIP CODE THAT WAS AT GREATEST RISK AND A BALANCED DEMOGRAPHIC GROUP THAT WASN'T AND GET AT SOME OF THOSE ISSUES IN GREATER DEPTH. WE WANT THIS TO BE DISRUPPIVE. WE WANT THIS TO BE A PLAYGROUND IN WHICH SMART IDEAS CAN COME IN AND UTILIZE THESE RESOURCES AND THE TEMPTATION IS THAT THE BASELINE CORE SHOULD PROVIDE INFORMATION FOR ALL OF THE INTERESTING QUESTIONS AND IT REALLY CAN'T AND SENT SHOULDN'T. YES, SHARON >> IT GOES WITHOUT SAYING YOU WILL, WE WILL TAKE INTO CONSIDERATION EVERYTHING THAT'S ALREADY BEEN DONE ON ALL OF THESE, I'M SURE WHAT YOU GET TO POLICIES, ANOTHER THE SAME THING. A COUPLE STRIKING THINGS TO ME. FOR EXAMPLE, THERE ARE SOME GOOD HING FROM. IN-THE-WILD EXPERIMENTS WE CAN FOR EXAMPLE, I JUST COLLECTED THE 20 DATA DICTIONARIES FROM THE 20 PATIENT POWERED RESEARCH STUDIES. THEY CALL AIM UP WITH WHATEVER THEY WANTED. IT WAS A COMPLETELY WILD EXPERIMENT, AND NOW, WE'RE LOOKING AT WHAT DID ALL 20, AND THIS IS PATIENT-PARTICIPANT LED. AD TO PICK TWO COHORTS. THERE'S A SKEW BECAUSE THEY ALL ONE COMMON, AND ONE RARE ACCIDENT BUT THEY'RE DISEASE-ORIENTED, WE HAVE PLIED. GAY, LESBIAN, BY SEXUAL. AND THERE'S BIOBANKS, AND I THINK THOSE WILL BE VERY HELPFUL. >> [SPEAKING AWAY FROM MICROPHONE] >> I HAVE A QUESTION ABOUT THE COMPONENT PARTS. IT'S PARTLY A PROCESS QUESTION: SO YOU'VE GOT THESE SIX CATEGORIES. ARE WE GOING TO SEE, OR WILL THEY BE DEVELOPED WITH SOME ASSEMBLANCE OF INTERDEPENDENCE OR GOING TO GO AUTONOMOUSLY. ONE OF THE THINGS THAT STRUCK ME ARE THE DISTINCTIONS OF PRATICALLITIES BETWEEN THE DIRECT VOLUNTEER. DIFFERENT BASELINE INFORMATION. BEFORE YOU KNOW IT, YOU MAY HAVE TWO DIFFERENT SAMPLES THERE IF WE DON'T WATCH OUT ON THAT BOTH OF THESE GROUPS AND THE ADVICE WE GOT FROM THE WORKING GROUP WERE TO USE THESE TWO DIFFERENT STRATEGIES FOR ENROLLMENT, BASED ON THE FANG THAT THESE PROVIDED DIFFERENT STRENGTHS AND WEAKNESSES, IN TERMS OF BOTH WHO WOULD BE BROUGHT IN AND IN TERMS OF SOME PRACTICAL CONVENIENCE SO WE WANT THE PROTOCOL TO BE AS THE SAME THERE MAY BE SOME PRACTICAL REASONS WHY IT CAN'T BE ABSOLUTELY IDENTICAL >> IT MAY BE WE HAVE ONE STREAM AND WE CAN ARC COMDATE THESE LITTLE DIFFERENCES. PUT IT ALL TOGETHER AND REALLY, THEY'RE NOT COMPARABLE AT ALL. >> NO, I THINK WE HAVE TO KEEP PAYING ATTENTION TO IT. I THINK THE CONTEXT HERE IS MOST IMPORTANT, WHICH IS, THIS IS A REASONABLE, I THINK THIS IS A GREAT PROCESS, BUT I'M NOT INTO BUT IT'S VERY IMPORTANT THAT PEOPLE REALIZE, WE'RE NOT TRYING TO GENERATE A WHITE PAPER, WE'RE TRYING TO GENERATE AN IMPLEMENTATION PLAN, BECAUSE WHITE PAPERS, YOU KNOW, THE WORKING GROUP REPORT, WE DIDN'T KNOW WHETHER WE WERE TALKING ABOUT THE NEXT YEAR OR THE NEXT 30 YEARS SO WE HAD TO BE SO VAGUE, AND SPECIFIC IN OTHERS. IS IS A GOOD PROCESS FORSSARY, IT IS WHAT ARE THE AWARDEES ON JULY 1 MODIFYING AND LITERALLY, I THINK WE NEED TO FIGURE OUT WHAT IS THE PURPOSE. IF PURPOSE IS TO GIVE MATCHING ORDERS WHICH THEY PUSH BACK ON OR GIVE THEM MATCHING ORDERS WHICH THEY START FROM. BECAUSE IF WE THINK ON, I NOTICED HOW YOU DIDN'T HAVE A SPECIFIC MONTH LISTED FOR ENROLLMENT ON THAT GRAPH. I LIKE THAT TECHNIQUE. SOMEWHERE AROUND SEPTEMBER 1. WE THINK SOMEONE'S GETTING ENROLLED IN HERE, IT CAN TAKE. EVEN AN ENGAGED IRB. IT COULD TAKE SEVERAL WEEKS TO SIGN OFF ON SOMETHING AS IMPACTFUL AS THIS. WE NEED TO BE HANDING THE AWARDEES ON JULY 1. THIS IS WHAT WE WANT TO YOU DO. TELL US WHETHER THIS IS UNREASONABLE OR INCONSISTENT IS MY SENSE WITH THAT TIMELINE. THAT IS INCONSISTENT WHAT WE HAVE BEEN SEEING, THAT WE WANT THE PARTICIPANTS REALLY INVOLVED IN DEFINING PROTOCOL. >> DON'T FORGET THAT PARTICIPANTS ARE BROADLY ENGAGED IN PHASE TWO AND THROUGH OUR DIRECT VOLUNTEER PILOT, WE WILL HAVE A SUBSET, DEFINITELY NOT A REPRESENTATIVE SUBSET, BUT I LIKE THE ARGUMENT YOU'RE MAKING BUT I KIND OF PLAYED AROUND DEVISING AN IMPLEMENTATION PLAN. DOES NIH SEEM A LITTLE HEAVY HANDED. SO I HELP PUT SOME GUIDANCE INTO THAT. WE ARE, IN SOME SENSE, GETTING CLOSE TONNA IMPLEMENTATION PLAN, BUT NOT QUITE RUNNING THE PROTOCOL. JUST FILLING UP ON SOME OF THE COMMENTS IN THE DISRUPTIVE SPACE THAT WE'RE WORKING IN. I THINK NA ONE OF THE KEY ELEMENTS WAS THE FACT THAT THIS -- WE'RE STARTING DOWN A PATH THAT WE'RE GOING TO BE ON FOR DECADES TO COME. THERE'S GOING TO BE ANORGANIC ASPECT TO IT AND YOU KNOW, WEEK AND TRY TO DESIGN SOMETHING PERFECT, AND IT STILL WON'T SERVE ALL THE NEED THAT IS WE HAVEN'T EVEN THOUGHT OF YET. IN SOME WAYS, HAVE YOU TO BEGIN, AND IT WILL EVOLVE, AND THERE WILL BE LESSONS LEARNED AND MODIFYING THAT IS HAVE TO HAPPEN. IT'LL BE ACCOMMODATIONS BUTT IDEA HERE IS TO BEGIN WITH A PLATFORM, THAT HAS GOT AS MANY POSSIBLE USES AS WE MIGHT THINK ABOUT TODAY AND WE KNOW, WITH THE ABILITY TO CONTACT AND RECOLLECT AND THE ABILITY TO UPDATE, THE CHECKED TOOLS, THE ABILITY TO CURE 8 THE DATA AND IN SOME CASES, WAYS WE HAVEN'T THOUGHT ABOUT YET. SO I THINK THE STARTING POINT DOESN'T HAVE TO CARVE EVERYTHING THAT WE COULD POTENTIALLY WANT TO DO IN STONE, AND SO THERE WILL BE SOME NEED TO ACCOMMODATE THE PRATICALLITIES OF IMPLEMENTATION, AND LATER, TOO ACCOMMODATE THE NEEDS OF A GIVEN TRADITIONAL OR EVEN UNIQUE INVESTIGATOR. >> THAT NEEDS TO BE EXPLICIT, ACTIVITY. THIS IS OUR LEVEL OF CERTAINTY FOR THE NEXT 12 MONTHS AND HERE OUR CHECK STEP, SIX MONS INTO RECRUITMENT. OTHERWISE, IT'LL TRY TO BE TOO CERTAIN OR VAGUE. SO IF YOU SAY THE PURPOSE OF THIS NEXT ACTIVITY IS TO ESTABLISH THE NEXT YEAR RECRUITMENT, I THINK THAT WOULD BE EXCEPTIONALLY HELPFUL TO THE PEOPLE DRAFTING THESE DOCUMENTS AND THE PEOPLE TRYING TO IMPLEMENT THESE DOCUMENTS AS WELL TO SAY THIS IS NOT ABOUT THE 5 YEAR VISION. THIS IS ABOUT THE FIRST YEAR VISION AND THEN WE'RE GOING TO MAKE THE SMALL MISTAKES AND THEN WE'RE GOING TO REESTABLISH OUR NEXT STEP. 18 MONTHS? >> THAT'S GREAT ADVICE. >> PROBABLY WON'T GET LANGUAGE AROUND THIS RIGHT. BII'M WONDERING IF SOME OF THESE WHITE PAPERS AND BACKGROUND DEVELOPMENT >> WE JUST RENAMED THEM IMPLEMENTATION DOCUMENTS >> OKAY. WHITE PAPERS. YEAH. SO THERE ARE SOME SPECIFIC GROUPS I WONDER WE DON'T NEED TO DO DEEPER WORK W. AT ONE OF OUR WORKSHOPS, WE HAD THE TRANSGENDER COMMUNITY THAT SAID THERE'S ABSOLUTELY NOTHING IN TRADITIONAL INTAKE FORMS AND HEALTH RECORDS THAT ARE ACTUALLY MEANINGFUL FOR US. AND THE [INDISCERNIBLE] REPORT DOES NOT GET AT THIS TIME AT IT, BUT THE PEER TOOL DOES. SO GETTING SOME TYPE OF ILLNESS ON THE DATA CHECK I WAS AT A WORKSHOP WHERE THERE WAS NOT CONSENSUS AROUND HOW YOU COLLECT INFORMATION REGARDING RACE, ETHNICITY ANCESTRY AND GENETICS AND I JUST ONEER HOW, YOU KNOW, ARE WE GOING TO LOOK ACROSS HPOS AND SAY, WHAT ARE WE COLLECTING AND HOW ARE WE GOING TO MAKE IT WORK FOR PME. THIS IS A NEW CRUCK FOR WHAT WORKS FOR PMI >> I THINK FOR OUR BASELINE ENROLLMENT INFORMATION, IT'S A NEW CONSTRUCT AND WE'RE NOT JUST EXTACTING IT FROM THE ROARS WE HAVE ALREADY. WE HAVE PULLED TOGETHER A LIST OF ABOUT EIGHT WAYS IN WHICH GENDER AND SEXUAL ORIENTATION QUESTIONS ARE ASKED AND IT IS THOUGHT OF AS A SPECIFIC TOPIC THAT WE HAVE TO FIGURE OUT A WAY D THIS NEED THAT WE CAPTURE, ISSUES RELATED TO MAJOR HEALTH DISPARITY SYSTEM -- DISPARITIES, IS LISTED AS A SEPARATE DOMAIN. WHAT ARE SOME OF THE STARTING QUESTIONS YOU WOULD USE, BUT THEN HOW DOES ONE DELVE INTO A SET OF QUESTIONS, YOU KNOW, ONE EVER BEEN INCARCERATED, IS THAT PART OF OUR FIRST 50 QUESTIONS OR NOT? I DON'T KNOW. BUT IT'S AN EXAMPLE OF A QUESTION THAT WILL BE QUITE IMPORTANT IN CERTAIN CONTEXT, BUT MAY NOT BE THE RIGHT STARTING QUESTION. THAT'S THE KIND OF ISSUE WE'RE GOING TO HAVE TO FIGURE OUT AND LEARN, AND GET OPPORTUNITIES FOR INPUT. BUT IT'S ONLY ONE. >> YEAH, AND JUST TO ADD ON TO THAT. I THINK SO WHAT THE DIRECT SELF-RESPECTING. HOW DO PEOPLE SELF-IDENTIFY THEIR RACE ETHNICITY. AND WHAT WE'RE FINDING A LOT OF TIMES IN HEALTH EXAMS, SOMEBODY LOOKS AT MANAGE AND SAYS, YOUR PHYSICAL CHARACTERISTICS ARE BLACK AND WE'RE WILLINGS YOU AS BLACK. SO I THINK THERE ARE SOME ISSUES AROUND THAT YOU KNOW, I'VE BECOME INCREASINGLY CONFIDENT THAT THE CORE DATA SET THAT WE'RE GOING TO BE WORKING WITH IS PARTICIPANT-PROVIDED INFORMATION INFORMATION. AND THE MORE I WATCH WHAT I'M SEEING, IN TERMS OF OUR QUANTITATIVE DATA, AS IMPORTANT AS MEDICATION EXTRACTED FROM THE HEALTH RECORDS ARE, IF YOU WANT TO KNOW WHAT PEOPLE ARE TAKING, YOU HAVE TO ASK THEM AND YOU HAVE TO ASK THEM IN A WAY THAT THEY KNOW >> JOSE, I FIND MYSELF REFLECTING WHEN YOU HAD THE SLIDE UP ABOUT THE PATIENT-PROVIDED INFORMATION. I DON'T FEEL LIKE EVERYTHING IN THE COHORT IS PATIENT-PROVIDED. I WONDER IF WE NEED TO DISTINGUISH THE PATIENT REPORTED PART. >> YEAH, THAT'S ABSOLUTELY RIGHT. THAT'S THE WRONG PHRASE. YEAH. >> BUT THAT'S WHAT YOU ARE INTENDING HERE. >> IT WAS ESSENTIALLY THE KIND OF ANSWERS TO QUESTIONS SO THERE IS A BUNCH OF EXCITING KIND OF PERFORMANCE. SO WE HAVE GOT A WHOLE POLICY CHAPTER TO JUST START TALKING ABOUT ALSO, BUT SHARON >> , I GUESS THE ONLY OTHER WATCH -- AND BY THE WAY, MY FRIENDS WHO ARE ENAMORED BY OUR DISCUSSIONS, SAID, MAKE SURE YOU'RE TALKING INTO THE MICROPHONES. YOU KNOW, THE PERFECT ENEMY OF THE GOOD THING IS SO THE SLIPPERY SLOPE HERE AND HAVING BEEN A PART OF CORNETT FOR TWO YEARS AND MAKING DECISIONS, YOU COULD JUST TWIST YOURSELF IN GOTS. AT THE END OF THE DAY, NOBODY IS HAPPY WHEN YOU MAKE A DECISION ABOUT ANY OF THIS WHICH IS A REALLY HORRIBLE PLACE TO START. BUT I LIKE THE CONVERSATION SO FAR IN THAT WE JUST BE VERY HAVE A START-UP STARTING UP AND IT NEEDS AN IMPLEMENTATION GUIDANCE AND IT NEEDS TO GO, AND WE'RE GOING TO LEARN AND IN 20 YEARS FROM NOW, WE'LL SAY, THAT WAS A DUMB MISTAKE BUT WE CAN IMPROVE THAT ON A RAPID SCALE. >> AND ONE THING THIS SET OF CONCLUSIONS OR BEGINNINGS, I'M NOT SURE WHICH OF THE TWO IT'LL BE. BENEFITS FROM, THERE ARE ACTUALLY RFA'S OUT NOW, YOU CAN OPINION 7 MILLION AND IT ENDS UP 1 NINETY ONE DOLLARS AND THAT IS AN IMPRESSIVELY IMPORTANT GUIDANCE. WE DIDN'T HAVE THAT AS A WORKING GROUP TO SAY, WHAT ARE WE ACTUALLY RESPONSIBLEOG PARTICIPANT, ON AVERAGE THROUGH THIS COHORT? THAT THAT WILL GET INTO VERY PRACTICAL ISSUES LIKE ARE WE CENTRIFUGING AT THE H.P.O. OR CENTRAL LIE? ARE WE DOING IT WITHIN 10 MINUTES OR THREE HOURS? I MEAN, THESE ARE MINUTIA THAT FUNDAMENTALLY CAN ADD OR REMOVE A ZERO FROM WHEN WE DO HERE AND NOW THAT WHOW MANY ZEROS ARE BEHIND THIS, WHOEVER -- AS WE REVIEW THIS, WE HAVE TO INCLUDE THOSE DOLLARS AMOUNTS. WE CAN'T COME UP WITH A SET OF RECOMMENDATIONS THAT ARE IGNORANT OF. >> YEAH, IT'S SORT OF A CORE RULE HERE. IF IT ONLY COST ACE HUNDRED DOLLARS PER PARTICANT. IT COSTS A HUMAN MILLION DOLLARS, YOU KNOW? [LAUGHTER] SO WE HAVE TO BE VERY CAREFUL, ND THAT'S THE OTHER ARGUMENT FOR KEEP TOGETHER SIMPLE IN THE BEGINNING. >> BY THE WAY, WE HOPE AND VERY MUCH BELIEVE, IF THIS IS WELL-BUILT, IT'LL BE THE BEST AND MOST COST EFFECTIVE WAY TO DO ALL SORTINGS OF OTHER THINGS AND FOR MANY OF THOSE, YOU NEED 20,000 OF THIS, AND 20,000 MATCH CONTROL. YOU DO NOT NEED A MILLION. SO WE THINK OF THIS AS CREATING A STRUCTURE THAT MAY MAKE LOTS OF KINDS OF QUESTION ANSWERING MORE COST EFFECTIVE. SO THAT'S WHY, I HAVE USED THIS MY CRITERIA, SOMEWHERE, WILL THIS HELP IDENTIFY, IS THE MEASURE IMPORTANT FOR SUBGROUP GROUP DEVELOPMENT. IT IS AN IMPORTANT PART OF WHAT BELONGS IN THE BASELINE. I THINK YOU'VE GIVEN ME ENOUGH INPUT TO KIND OF REBRIGHT THIS AND TURN THIS INTO A ONE-PAGER FOR YOU TO RESPOND TO. I'M SURE THAT I'M SURE LANGUAGE STILL NEEDS MORE TWEAKING AND WHEN YOU SEE IT AND READ T I'D LIKE YOU TO IMMEDIELY PHONE ME, E-MAIL, TEXT ME, WHATEVER WAY YOU CAN WITH OTHER THOUGHTS AND WE'LL KEEP MATURING THIS APPROACH. I THINK IT'S ALSO IMPORTANT HOW WE DO OUR TIMELINE. WELL, WHY DON'T WE HEAR, CARRIE HAS BEEN THINKING AND, WONDERING HARD ON HOW TO APPROACH AND IDENTIFY SOME OF THE CRITICAL POLICY QUESTIONS. SO LET ME TURN THE FLOOR OVER TO HER MAYBE WALK AROUND THE TABLE. TO GET A FEW MORE STEPS IN. SO AS JOSE MENTIONED, WE'RE SPENDING A LOT OF TIME THINK GOING POLICY, AND I SHOULD SAY FROM THE OUT SET THAT WHEN I USE THE PRONOUN "WE" I'M TALKING ABOUT MY COLLEAGUE, SITTING ACROSS THE ROOM HERE, WHO HAS REALLY DOING A LOT OF THE BOOTS ON THE BROWN, HARD WORK AND COORDINATION FOR THE POLICY ASPECTS OF THE PMICOHORT PROGRAM. WE WERE REALLY STARTING IN TRYING TO THINK CENTRALLY ABOUT ALL THE POLICY PIECES COHORT PROGRAM FROM THE VERY NICE BONES THAT WERE LAID OUT IN THE ACD WORKING GROUP. THAT EVERYTHING RASE FROM SOME VERY SPECIFIC RECOMMENDATIONS TO SOME VERY SORT OF BROAD IDEAS AND SO THAT'S REALLY OUR SORT OF INITIAL BLUEPRINTS, PRIMARY, CHAPTER 7 OF THE WORKING GROUP REPORT. BUT THERE ARE POLICY ISSUES, SORT OF SPRINKLED THROUGHOUT AND WE'RE THINKING ABOUT THIS, AS I MENTIONED, IN SORT OF BOTH THE KIND OF BIG P POLICY SENSE IN TERMS OF, YOU KNOW, WHAT ARE WE AS THE MIH AND THE OFFENSE OF SCIENCE POLICY, AND SOME OF THE OTHER AGENCIES THAT HAVE PMIAND SOME OF THE RULES, STATUTES, REGULATION THAT IS EFFECT PME. HOW CAN WE WORK TOGETHER TO EFFECT CHANGE THAT IS >> PROFESSOR: MOTIONAL TO MAKING COHORT HAPPEN, WHETHER IT'S REGULATORY HARM HARMONIZATION. S. PROTECTS, STATE LAWS AND THEIR BREAKS WITH THINGS LIKE VULNERABLE POPULATIONS AND CONSENTS AND THERE'S THE IT IS PEA POLICY. SO ALL OF THE SORT OF HOW THE POLICY ISSUES ARE OPERATIONALLIZED INTO THE COHORT PROGRAM AND HOW WE PUT TOGETHER SORT OF A PLAYBOOK FOR EVERYONE INVOLVED IN PMI THAT TOUCHES ON THE PRINCIPLES AND POLICIES WE WANT TO MOVE FORWARD. AND THERE ARE SOME INTERESTING POLICY CHALLENGES, WHICH WE HAVE HEARD THROUGHOUT THE COURSE OF THE DAY, RELATED TO PMI, IN TERMS OF THE THINKING OUTSIDE THE NORMAL WAY WE DO BE, WHEN IT COMES TO POLICY DEVELOPMENT; INCLUDING STARTING WITH THE QUESTION HOW WILL THIS POLICY DIG BUILD OR HARM THE RELATIONSHIP AND TRUST THE PARTICIPANTS IN THE COHORT. AND YOU IMAGINE, THIS IS A QUESTION WHO'S ANSWER MIGHT EVOLVE OVER TIME, AS WE DO BUILD THE COHORT AND THERE'S A RELATIONSHIP DEVELOPED BETWEEN MEMBERS AND PARTICIPANTS OF THE COHORT AND PMIAS SORT OF A CENTRAL GOVERNANCE PROCESS, BUT I THINK IT'S SOMETHING WE TRY TO, ON A REGULAR BASE, PUT OURSELVES INTO THE SHOES OF OTHER PARTICIPANTS AND PMI'S, TOO HELP US THINK OF THE QUESTIONS AND SOMETHING ELSE THAT'S ALSO VERY UNIQUE AND WE'RE SPENDING A LOT OF TIME THINKING THROUGH, AS YOU HEARD EARLIER, THE PRINCIPLES OF PMI OF COURSE, IS THAT THERE WILL BE SOME WAY TO ACCOMMODATE PREFERENCES. SO CREATING POLICIES THAT ARE FLEXIBLE ENOUGH, TOO ACCOMMODATE A RANGE OF PREFERENCES ON THINGS LIKE, ACCESS TO DATA, RETURN OF RESULTS, CONSENT, HOW OFTEN PEOPLE WANT TO BE RECONTACTED, ALL OF THESE THINGS, YOU KNOW, WHATEVER POLICIES THOU SHALT SORTS OF THINGS WE NEED TO PUT FORWARD. WE NEED TO ACCOMMODATE THAT KIND OF PREFERENCE. SO WHAT WE'VE BEEN DOING AND HAD N SOME WAY IS ANALOGOUS TO WHAT JOSE DESCRIBED, IS INGOING TO PUT DOWN ON PAPER A FRAMEWORK OF ALL THE POLTSES RELATED TO PMI, REALLY BUILT ON THE BONES OF THE WORKING GROUP RECOMMEND EGGS AND SOME OF THE THINGS LAID OUT IN THE FUNNELING OPPORTUNITY ANNOUNCEMENTS AS WELL. THERE ARE EXPECT TRANSCRIPTIONS, RELATED TO POLICIES FOR THE AWARDEES, WE WANT TO MAKE SURE WE'RE CAPTURIZING AND CENTRALIZING IN ONE PLACE ARE SO WE'RE CONSISTENT, GIVEN THE WIDE RANGE OF VERY RAPIDLY, MOVING AND EVOLVING OPPORTUNITIES AND I THINK AS WE GO FORWARD AND DEVELOP THIS SORT OF PLAYBOOK. THIS FRAMEWORK OF POLICIES, WE SEE THIS AS BEING A ITERATIVE FASHION, MUCH OF WHAT JOSIE DESCRIBED IN THE SENSE THAT I THINK WE CAN, WE, THE NIH AND THE OFFENSE OF SCIENCE POLICY, WORKING WITH THE PMICOHORT PROGRAM, AND ALL OF YOU, CAN BEGIN TO POPULATE THAT FRAMEWORK WITH, YOU KNOW, SOME DECISION THAT IS OF COURSE MADE, SOME OPTIONS, BUT I THINK WE ARE VERY CONSCIOUS OF THE FACT THAT WE ARE IN A STAGE IN WHICH PARTICIPANTS ARE REALLY ACTUALLY PREPPIVE PARTICIPANTS, RIGHT? BECAUSE NOBODY'S ACTUALLY ENROLLED YET. SO IN THEORY, WE ARE ALL PERSPECTIVE PARTICIPANTS. THAT AT SOME POINT, WHEN WE REALLY WANT IS TRUE PARTICIPANT ENGAGEMENT SO PEOPLE ARE ACTUALLY IN THE COHORT, GIVING VOICE TO THEIR GOVERNANCE OF THE COHORT ITSELF. SO I THINK WE SEE THIS AS SOMETHING THAT VERY EVOLVING OVER TIME N A VERY REAL WAY TO ACCOMMODATE THE GROWTH OF THE PROGRAM, AS WELL AS THE SET UP OF THESE NEW GOVERNANCE STUCKURE STRUCTURES. ONE THING WE WERE SPENDING A LOT OF TIME TALKING ABOUT, INTERNALLY, AND AND WE GOT A SENSOR OF IT FROM THE TIME JOSE JUST SHOWED, THE VISION ORIGINALLY OUTLINED IN THE WORKING GROUP REPORT, HAD A LOT OF POLICY DECISIONS BEING MADE BY GOVERNANCE STRUCTURES, WITHIN THE STEERING COMMITTEE, THROUGH THE COORDINATOR CENTER. WELL, THOSE GOVERNING STRUCTURES AREN'T GOING TO MISS UNTIL WE HAVE A COORDINATING CENTER DOWN THE ROAD AND WE MIGHT NEED TO MAKE SOME DECISIONS FOR THAT. WHAT ARE THE DECISIONS THAT WE EK YOUR INPUT INTO, AND I'LLE BE INTERESTED IN HEARING FROM YOU ON THIS. AND WHAT CAN WE KICK THE CAN DOWN THE ROAD AND SAY, OKAY. WE'RE GOING TO WAIT UNTIL WE HAVE A DATA ACCESS SUBCOMMITTEE OR A PRIVACY AND SECURITY SUBCOMMITTEE TO HELP MAKE THOSE DECISIONS. I ALSO THINK THAT WE WILL FAVOR A VERY TRANCE PARENT EVOLUTIONARY PROCESS. SO IT MIGHT MICK SENSE TO PUBLICLY DISPLAY, HOW OUR POLICIES CHANGE OVER TIME SO CAN YOU SEE DIFFERENT VERSIONS AS INPUT COMES IN, AS DECISIONS ARE MAY AND JUST A LIST OF TOPICS, THEY ARE VERY MUCH RESNENT WITH THE TOPICS . I THINK, BEGINNING WITH SORT OF THESE HIGHER LEVEL PRINCIPLES AND OF COURSE, OUTLINING WHAT'S INVOLVE IN THE POLICY DEVELOPMENT PROCESS, WITH AGAIN, MAKING SURE THAT PARTICIPANTS, AND THE ROLL OF PARTICIPANTS AND THE PERSPECTIVE OF PARTICIPANTS ARE SORT OF FRONT AND CENTER IN THAT. ISSUES RELATED TO INFORM CONCENT WHETHER WE WANT TO SET SPECIFIC EXPECTATIONS YARDS FOR SPECIAL POPULATIONS. GWEN TOUCHED ABOUT THIS A LITTLE BIT. THIS MORNING, WHETHER IT'S CHILDREN, WHETHER IT'S ISSUES RELATED TO SUBSTANCE ABUSE OR COGNITIVE UMPIREMENTS, PEOPLE WHO ARE INCARCERATED. JOSE CANNED THE QUESTION, WOULD YOU KNOW TO ASK. HAVE YOU EVER BEEN INCARCERATED. BUT WE MIGHT WANT TO ASK THE QUESTION, ARE YOU CURRENTLY INCARCERATED BECAUSE THAT DOES HAVE IMPLICONS FOR CONSENT AND SOME OTHER ISSUES. INDIVIDUAL RETURN OF RESULTS AND INFORMATION AND ACCESSING PMIDATA RESOURCES. ONE OF THE THINGS WE ARE SORT OF CATCHING OURSELVES, AS WE TRY TO PUT SOME PLEAS ON THE BONES OF SOME OF THESE ISSUE SYSTEM TO MAKE SURE WE'RE DIFFERENTIATING BETWEEN ACCESS TO DATA AND RETURN OF RESULTS, WHICH HAVE SOME CROSSOVER BUT ARE NOT THE SAME THING, AND FROM A POLICY POINT OF VIEW, HAVE POTENTIALLY DIFFERENT CONSIDEREDS. AND YOU KNOW, ACCESSING PMI RESOURCES, YOU KNOW, WE'RE REALIZING, IT'S NOT ONE GIANT RESOURCE. CAN YOU BREAK IT DOWN INTO, THERE'S THE BIOBANK AND SPECIMENS IN THE BIOBANK. THERE'S THE DATA AND THE PARTICIPANTS THEMSELVES, THAT'S SORT OF A HUMAN RESOURCE AND WHAT ARE ALL THE CONSIDERINGS OF ACCESS FROM ALL THE TAKE HOLDERS INVOLVE IN PMIWE ASK OURSELVES QUESTIONS LIKE WELL, WHAT IF A PARTICIPANT COMES AND SAYS, I WANT ACCESS TO MY SPECIMEN IN THE BIOBANK? DO WE SAY OKAY. HERE'S YOUR BLOOD NOT IN THE I WANT TO WITHDRAWL IT SORT OF SENSE, BUT ILL LIKE TO TRACHE THIS SOMEWHERE ELSE FOR TEST FOR WHATEVER REASON. YOU KNOW, WHAT IS OUR APOLOGIES AROUND THAT? I DON'T HAVE AN ANSWER BUT THESE ARE THE SORTS OF QUESTIONS WE'RE TRYING TO GET OUT OF THE BOX AND ASK OURSELVES BOTH IN TERMS OF THE VERY PRACTICAL SETTING UP THE CENTRAL IRB BECAUSE WE'RE GOING TO NEED THAT UP AND READY VERY SOON AS WE START ROLLING OUT SOME OF SOME OF THE AWARDS AND THE PROTOCOL. BUT ALSO THINKING THROUGH QUESTIONS OF HOW EXACTLY ARE WE GOING TO USE THE MATERIAL IRB FOR PMIAND WILL THAT CHANGE OVER TIME SO WHAT IS THIS IRB ACTUALLY GOING TO BE REVIEWING? YOU COULD IMAGINE IN THE BEGINNING, THEY MIGHT BE REVIEWING EVERYTHING. WE SET UP, WE'RE AIMING TO SET UP A VERY UNIQUE CENTRAL IRB IN THE SENSE THAT WE'RE REALLY AIMING TO HAVE STRONG, PARTICIPANTS, INVOLVEMENTS AS WELL AS EXPERTISE, SPECIALIZED TO THE UNIQUE ASPECTS OF THE UNIQUE PMI COHORT PROGRAM. GENOMIC, HEALTH DISPARITIES, ET CETERA. YOU KNOW, WILL NA IRB, FIVE YEARS DOWN THE ROAD, BE REVIEWING RO1 APPLICATIONS THAT WANT ACCESS TO PMI DATA? I DON'T KNOW THE ANSWER TO THAT. BUT THAT'S THE SORT OF THING WE'RE TRYING TO BEGIN TO THINK THROUGH AND LAYOUT SOME OPTIONS FOR. DATA SECURITY AND PRIVACY, OF COURSE, BEING BUILT ON THE WHITE HOUSES, FRAMEWORK, RELATED TO PRIVACY AND OH. WORKING VERY CLOSELY WITH THE FOLKS, THE GROUP THAT'S WORKING ON THE BIOBANK SO WE MAKE SURE THAT POLICIES ARE DECIDED SORT OF CENTRALLY FOR PMI ARE CONSISTENT ACROSS THESE THINGS. ARE WE GETTING THE RIGHT LIST HERE, ARE THERE THINGS STILL MISSING, I CAN SELF-IDENTIFY SOMETHING WHICH IS NOT ON THE LIST. THERE'S NOTHING ABOUT MOBILE HEALTH HERE. ALTHOUGH ONE COULD IMAGINE A HOST OF POLICY ISSUES. SOME OF THAT IS EMBEDDING IN SOME OF THESE OTHER THINGS LIKE DATA ACCESS AND SECURITY AND PRIVACY. BUT ALSO BECAUSE I THINK MOBILE HEALTH TECHNOLOGY IS VERY NEW AND THERE'S STILL A LOT OF EMORPHOUSNESS TO THE POLICY SO THINKING THROUGH WHAT EXACTLY ARE THE POLICY DISCUSSIONS WE NEED TO HAVE THERE IS SOMETHING WE'RE GIVING A LOT OF THOUGHT TO. SO JUST TO GIVE YOU AN EXAMPLE OF THE SORTS OF QUESTIONS THAT WE PONDER. YOU KNOW, THE OLD LINE FROM THE MOVIE "JAWS" WE'RE GOING TO NEED A BIGGER BOAT. PMIMAKES ME FEEL LIKE WE'RE GOING TO NEED A BIGGER WHITE BOARD AS WE'RE GOING TO GET INTO THESE DISCUSSIONS AND THINKING THEM THROUGH. THINGS LIKE HOW WILL THE PARTICIPANT REFLECTIVES BE PERFECTED WHEN IT COMES TO ACCESS FOR DATA AND SPECIMENS. SO THIS IS THE PERSPECTIVE PARTICIPANT POINT OF VIEW, RIGHT? HOW DO WE MAKE SURE OUR PLACEHOLDER POLICIES, UNTIL WE GET OUR GOVERNANCE GROUP IF PLACE ARE APPROPRIATELY REFLECTING THE PERSPECTIVES OF ENROLLEES IN THE COHORT PROGRAM. WHAT'S THE LONG-TERM ROLE OF THE PMRIRB IN HOW WILL THAT EVOLVE OVER TIME. WHAT ARE SOME OF THE EXPECTATIONS FOR INTELLECTUAL PROPERTY, COMMERCIAL INTEREST. AND WE SPEND A LOT OF TIME TRYING TO GET TO THIS SORT OF TIMING AND SEQUENTIAL ISSUE OF, YOU KNOW, WHO MAKES THESE DECISIONS RELATED TO POLICIES, AT WHAT TIME, YOU KNOW, HOW MUCH DO WE DECIDE TO DICTATE KIND OF CENTRALLY, HOW MUCH DO WE LEAVE TO AWARDEES. DO WE SAY, DEAR PMIAWARDY, GO FORTH AND DEVELOP A GOVERNANCE PROCESS, IN ORDER TO CREATE A RETURN OF RESULTS POLICY OR DO WE SAY, HERE IS YOUR COMPLETELY FULL OF FORM RETURN POLICY OR IS IT SOMETHING IN BETWEEN. DO WE GIVE TM REALLIES, THAT'S A LOT OF WHAT WE THINK ABOUT, AS WELL AS, YOU KNOW, HOW CAN WE USE THE PILOT PROGRAM AND JOSE'S ALREADY TALKED ABOUT THIS. TO SORT OF EXPERIMENT WITH SOME OF THESE QUESTIONS, WHERE WE'RE UNCERTAIN, HOW CAN WE USE THE PILOT PROGRAM TO GET DIRECT INPUT FROM PARTICIPANTS, ACTUAL PARTICIPANTS WHO ARE ENROLLED IN HELPING US WORK THROUGH SOME OF THESE QUESTIONS AND ANSWERING SOME OF THESE QUESTIONS. SO WITH THAT, I WILL STOP TALKING. I'M GOING TO GO BACK TO THE TABLE AND I'M HAPPY TO CHAT HAD MORE. >> GREAT JOB, CARRIE. JUST ONE THING, AND I THINK I KNOW WHAT YOU MEAN, BUT OPTICS AND OTHER THINGS AROUND TRUST, I THINK IT WOULD BE A GOOD IDEA TO EXPAND A LITTLE. SO I WOULD TAKE THE TERM "INFORM CONSENT" AND BROADEN IT TO SOMETHING LIKE, ENGAGEMENTS. BY THAT I MEAN, THE FOCUS IS JUST ON THE TRANSACTION, RIGHT, THERE'S A LOT OF OTHER ASPECTS TO THIS. IN SOME CASES CAN WE USE NOTIFYINGS,? N? CASES CAN WE USE REPEAT MESSAGES AND I THINK WE. THAT A LITTLE I'M NOT SURE DISPARITIES, THAT THERE ARE LOTS OF ETHICAL ISSUES ABOUT THAT THAT WILL START TO EMERGE WHEN WE TART TO DO THIS. WHETHER WE'RE DOING EVERYTHINGT. HAVE WE STILL MISSED IT AND IS THAT THE ONLY SORT OF THING WE WANT TO MEASURE AND HOW WE WANT TO MEASURE IT. >> AND ACTUALLY, YOU KNOW, THAT PIVOTS ONTO ANOTHER QUESTION WE'RE ASKING WHICH IS THE ROLL OF THE IRB VERSUS VARIOUS GOVERNING POLICIES, ADDRESSING THESE ETHICAL ISSUES AS WELL IS SOMETHING WE NEED TO THINK A LITTLE BIT MORE ABOUT. ROARING POLTS REGARDING BECKUAL PROPERTY, IT'S COLLABORATIVELY CREATED. TOOLS AND PROCESSES CREATED AS PART OF THIS ENTERPRISE, VERSUS INTELLECTUAL PROPERTIES THAT ARE RESULTS OF RESEARCH. THE LADDER ONE IS REALLY COMPLICATED. BUT TO MY MINE, WHAT I LIKE TO PROPOSE IS THE FORM SERVED POPULATIONS QUITE SIMPLE. IT'S ALL IN THE PUBLIC DOMAIN AND THIS WAS A HARD REQUIREMENT OF THE COLLABTORY PRAGMATIC TRIAL. ALL COLLABORATIVE PROPERTY MUST BE PUBLIC AND THAT WAS NONNEGOTIABLE AND THAT WAS A REALLY GOOD THING. THINKING BACK WHAT JOHN WAS TALKING ABOUT, THE POTENTIAL TO CREATE REALLY USEFUL TOOLS AND WE'D WANT TO HAVE A CLEAR UNDERSTANDING AT THE BEGINNING THAT THOSE TOOLS BELONG TO THE PUBLIC. >> I NOTICED IN THE CARTOON. CHEERS. SO ONE OF THE THINGS THAT STRIKE ME, AND I'VE BEEN INVOLVE A LOT OF THESE DISCUSSIONS, ONE OF THE THINGS THAT KEEPS COMING BACK TO ME IS HOW DO WE MAKE SURE THAT WE ARE SUFFICIENTLY OPEN AND ENGAGED, EVEN IN THE EARLY DISCUSSIONS. I THINK IT'S SORT OF RELATED TO WHAT YOU HAVE, TOO, JOSE AND I DON'T KNOW WHAT THE ANSWER IS. CLEARLY, YOU GUYS ARE GOING TO BE PROVIDING ONGOING INPUT, BUT SEEMS THER'S GOING TO BE A LOT OF WORK THAT GOES ON, BETWEEN THE TIME THAT WE CONVENE YOU, AND I DON'T KNOW THAT THERE'S SOME SUBGROUP OF THIS GROUP, THAT WOULD PARTNER WITH CARRIE'S GROUP TO THINK THROUGH SOME OF THESE ISSUES OR WITH THE WHITE PAPER IMPLEMENTATION PLAN GROUP. IT FEELS LIKE THERE MIGHT BE ANOTHER LEVEL OF ENGAGEMENT THAT WE CAN DO, UNTIL WE GET THAT GOVERNANCE STRUCTURE IN PLACE. I DON'T KNOW. >> AS YOU'VE HEARD ALL OF THESE DUGS AND PIECES WE'RE TALKING ABOUT. I DO SEE YOU AS A SOUNDING BOARD FOR THE PRODUCTS THAT EMERGE IN ALL OF THEM. BUT WILL VERY MUCH WELCOME, VOLUNTEERS TO HELP THE SPECIFIC PIECE OF THOSE. IF YOU SEE PIECES OF THIS PROCESS, YOU WOULD PARTICULARLY LIKE TO BE ENGAGED IN, PLEASE LET US KNOW. THAT WILL NOT KEEP US FROM ASKING YOU, REGARDLESS OF WHETHER YOU VOLUNTEER TO HELP WITH ALL OF THESE PIECES. BUT MANY OF THESE PIECES ARE INTERCONNECTED AND AS WE TALK MORE ABOUT THIS MORNING, WE'RE TRYING TO MAKE THIS, GET THE RIGHT MIDDLE GROUND BETWEEN THIS BEING AN I. IMPLEMENTATION OR A SPECIFICATION PROCESS, IDENTIFY AREAS WHERE IT IS APPROPRIATE FOR THE FEDERAL GOVERNMENT TO SET THE RULES AND IDENTIFY WAYS IN WHICH WE CAN DO OUR BEST TO MAINTAIN MORE FLEXIBILITY WITHOUT SLOWING THE WORK DOWN MAYBE THAT'S WHY I THOUGHT I HAD TO DRAFT ACCESS. >> ROB ONCE LABELED ME A RADICAL LIBERAL -- I'M GOING TO GET A T-SHIRT AND WEAR IT EVERY DAY. >> MIKE. >> YEAH, I THINK THIS IS ANOTHER AREA WHERE THIS IS GOING TO BE A DISRUPTIVE ACTIVITY. WHAT WE HAVE NOT DONE IS TAKEN ON SOME OF THE KEY INNOVATION POLICIES. WHAT WE HAVE DONE, IS UNDERSTOOD RETROSPECTIVELY WHERE THE POLICY LANDSCAPE S AND PLAYED DESIGN STAYING AWAY FROM THE BOUNDARIES. I THINK THIS INITIATIVE HAS GOT SUCH MOMENTUM, I THINK IT HAS THE POTENTIAL TO DRIVE SOME OF THE POLICY DECISIONS. IT CREATES A LITTLE BIT OF A CHALLENGE WHEN YOU'RE TRYING TO IMPLEMENT IN PARALLEL WITH THE POLICY LANDSCAPE THAT'S CHANGING A LITTLE BIT. I THINK THAT'S GOING TO HAVE TO BE KEPT IN MIND THAT, YOU KNOW, YOU'RE DESIGNING SOMETHING THAT HAS CONCRETE DECISIONS, HAVE YOU TO MAKE WITH THAT POLICY CONSTRUCT, AND THE POLICY CONSTRUCT CHANGES. >> WE CAN'T ACTUALLY BREAK ANY LAWS AND WE HAVE TO LIVE WITHIN THE RE GS. BUT WE ARE ALSO WORKING TO CHANGE THEM. PMIFOR A POLICY THAT DOES NOT EXIST OR FROM A MODIFYING OF A CURRENT POLICY, WE ARE PURSUING THAT PRETTY ACTIVELY AND THERE IS LEGISLATION THAT MAY OR MAY NOT BE MOVING ON THE HILL, PASSED IN THE HOUSE. MAY OR MAY NOT BE MOVING IN THE SENATE: INNOVATION IN THE SENATE, AND THERE ARE IDEAS THAT WOULD BENEFIT THE COHORT SOME IMPORTANT AREAS THAT THOSE OF US OF COURSE WORKING AWAY AND HAS SEEN A DESIRABLE CHANGE. IN FACT, THE FACT THAT WE'RE WORKING SO MUCH MORE CLOSELY WITH THE OFFICE OF THE NATIONAL COORDINATOR IS ONE WE'RE ONE, IS I THINK, A VERY CLEAR IMPACT OF PME. >> WE WEREN'T FRIENDS BEFORE >> OF COURSE. WE'RE FAMILY. I JUST WANT TO ADD. IF YOU'VE GOT LAWYERS, BRING 'EM. WE'RE GOING TO NEED THEM. WE KNOW WHERE WE SPEAK. >> OH, YES. >> SO I'M MODERATELY TORMENTED HERE, BY THE KIND OF BALANCE THAT WE'RE GOING TO NEED TO HAVE, TO BE ABLE TO DO THIS QUICKLY ENOUGH TO GET ROLLING. AGAIN THIS TENSION AND SOMETHING YOU SAID, KATHY MOSTLY MEANT THAT WE SHOULD ALL CONSCRIPT OURSELVESES TO VARIOUS THINGS, AND THAT IS, THE DEGREE TO WHICH WE CAN ENGAGE PARTICIPANTS DEEPLY EVEN NOW. SO I KNOW WE DID A PRETTY GOOD JOB OVER 2015 OF GETTING PEOPLE'S OPINIONS ABOUT ALL THESE TOPICS, ACTUALLY, IF WE WENT THROUGH THE TRANSCRIPTS, WE SURE THAT'S WHAT YOU'VE DONE. ON THE OTHER HAND, WHEN I HEAR FROM THE PEOPLE, WE STILL HAVE SOMETHING ELSE TO SAY. SO THE IDEA BEING THAT IT MIGHT BE A LITTLE OUT OF THE BOX, BUT TO FIGURE OUT SOMETHING THAT CAN BE USED TO KEEP GETTING PUBLIC OPINION AND I KNOW THE OTHER PART OF THIS IS THEN YOU SAY, IF WE'RE NOT PAYING TENACIN AND RESPONDING TO EVERY ONE OF THOSE, YOU KNOW, MESSAGES, WE'RE NOT RESPONSIVE. BUT THERE ARE WAYS WITH NEWER KIND OF PLATFORMS TO QUICKLY A MAS THINGS, SEE WHAT'S SERVICING, LET THE PEOPLE HAVE CONVERSATION AND BRING THIS STUFF FORWARD INTO SOME OF THESE POLICIES. >> TOTALLY AGREE AND I THINK OUR AWARDEES FOR THE TWO SOLICITATION THAT IS I THINK WE'RE GOING TO START TALKING ABOUT CONCEITLY WILL ALLOW US A FUNDED MECHANISM TO DO SOME OF THAT BECAUSE I THINK WE WILL HAVE SOME REAL PARTICIPANT VOLUNTEERS. WE WILL HAVE AN 80 TO PULL TOGETHER. FOCUS GROUP OR OTHER THINGS TO CAPTURE, I THINK BETTER THAN WE HAVE DONE BEFORE, THE NEED FOR THIS KIND OF IMPLEMENTATION >> AND I WOULD ALSO ADD TO THAT, JOSE MENTIONED THE SEPARATION BETWEEN PROTOCOL AND POLICY. ONE THING I THINK THAT IS USEFUL AS SORT OF THE PROGRAM AND THE PROTOCOL BECOMES CLEARER, YOU KNOW, A LOT OF THESE THINGS, WE TALK ABOUT THEM IN THAN TRACT, AND PEOPLE OFFER THEIR OPINIONS AND THEY AB TRACT AND SO THE CLOSER WE GET TO SORT OF WHERE THE RUBBER MEETS THE ROAD POINT, I FEEL LIKE THE MORE USEFUL THE ANSWERS TO THE QUESTIONS ARE. BECAUSE THE QUESTIONS ARE GETTING MORE SPECIFIC I THINK THAT IS SEEN REFLECTED. YOU'VE GOT THE 30,000-FOOT LEVEL COMMENTS WE HEARD THROUGH THE PLANNING PROCESS, AND NOW, AS WE'RE BEGINNING TO SEMENTAL HEALTH THE PROTOTYPE PIECES. IT'S EASIER FOR US TO COME BACK AND I SAY, OKAY. THIS IS WHAT WE REALLY MEAN. NOW WHAT'S YOUR OPINION AND IT'S IMPORTANT TO KEEP TO GO THAT AS WE GET MORE AND MORE TANGIBLE. I HOPE WE HAVE A MECHANISM FOR CONTINUOUS EVALUATION FROM THE PARTICIPANT PERSPECTIVE OF WHAT WE NEED TO CHANGE AND WHAT WORKED. A QUICK RIMER ON OTHER TRANSACTION AUTHORITY. S IN JUST A FEW SLIDES TO GIVE YOU A LITTLE BACKGROUND ON THE ACTUAL AUTHORITY ITSELF. AND HOW IT LENDS ITSELF TO PME. -- NOT A GRANT, NOT A CONTRACT AND NOT A COOPERATIVE AGREEMENT. IN MANY WAYS, THE KEY BEING THAT O.T. AGREEMENTS ARE NOT SUBJECT TO THE FAR AND NOT SUBJECT TO THE COST ACCOUNTING STANDARDS, WHICH CREATES QUITE A BIT OF FLEXIBILITY AND THE 80 TO NEGOTIATE WITH OUR APPLICANTS AND AWARDEES IN THESE AGREEMENTS. THE OTHER ITEM OF NOTE IS O.T. AGREEMENTS ARE NOT SUBJECT TO G.A.O. PROTESTS WHICH I'M SURE IF YOU ARE INVOLVED IN COUNSEL, YOU ARE ALL AWARE OF SOME OF YOUR INSTITUTES HAVING TO GO THROUGH PROTESTS WITH CONTRACTS AND THINGS OF THAT NATURE >> JUST TO AMPLIFY ON THAT, THERE OF COURSE OCCASION WHERE IS NIH HAS ISSUED EYE CONTRACT TO DO CERTAIN KIND OF WORK LIKE PROVIDE AN INFRASTRUCTURE FOR CLINICAL TRIAL DATA CHECKED AND HAD THE UNSUCCESSFUL APPLICANT PREVENT THE ISSUING OF THE AWARD AND THIS CAN TIE UP THE AWARDING PRESSES FOR YEARS. LITERALLY. AND SO WE KNEW IF WE TRIED TO DO SOME OF THIS WORK WITH CONTRACTS. IT WOULD KE US 6-8 MONTHS TO GET THE SOLICITATION. BUT IF THERE WAS A REAL DANGER SOMEONE WAS UNHAPPY THEY COULDN'T GET IT, COULD KEEP US FROM GETTING AN AWARD. THAT'S THE REASON, ONE OF THE REASONS WHY THE O.T. AUTHORITY IS THOUGHT BY ALL AGENTS THAT USE IT TO GIVE THEM IMPORTANT FLEXIBILITY >> SO AT THIS TIME, THERE ARE 11 AGENTS THAT HAVE ON O.T. AUTHORITY. SOME IN DIFFERENT MEMBERSHIPS THAN OTHERS. D.O.D. HAS SPECIFIC LANGUAGE WITH REGARDS TO THE LANGUAGE PROTOTYPE. HOWEVER, AGENCIES SEES SUCH AS NASA AND TSA ALSO USE O.T. AUTHORITY FOR EDUCATION AND OUTREACH. THAT WILL BE IMPORTANT TO US AS WE TALK ABOUT OUR SOLICITATIONS LATER. THE OBVIOUSLYIVE, AND AND I'LL REPORT TO A G.A.O. REPORT, CUTTING EDGE TECHNOLOGY, FROM PARTNERS WHO GENERALLY DON'T, FOR WHATEVER REASON, PARTNER WITH THE FEDERAL GOVERNMENT, TOO ALLOW US TO BRING IN THE RIGHT EXPERTISE IN ORDER TO ACCOMPLISH CERTAIN TASKS. HIGH FLEXIBILITY, SPEED AT WHICH WE CAN GET THE AGREEMENTS IN PLACE AGAIN, THE TERMS AND CONSCIENCE ARTERM -- TERMS AND CONDITIONS. IT'S A VERY INTERESTING TWIST TO THE NORMAL PROCUREMENT TYPES THAT WE HAVE INSIDE THE FEDERAL GOVERNMENT I RECOMMEND, IF YOU CAN, TO GO TO THE G.A.O. WEBSITE, WHERE JUST LAST WEEK, THEY PUBLISHED THEIR MOST RECENT USE OF OTHER TRANSACTION AGREEMENTS WITHIN THE FEDERAL GOVERNMENT IT IS A 41 PAGE DOCUMENT BUT DO NOT DESPAIR. THEY'D ONLY HALF THE REAL ESTATE ON EACH PAGE, AND IT IS QUITE FASCINATING TO SEE HOW THE DIFFERENT AGENCIES HAVE USED O.T. AUTHORITY. NIH IS INCLUDED IN THIS REPORT, BUT I WILL NOTE, THAT A MAJORITY OF THE RESEARCH FOR THIS ARTICLE WAS DONE IN FISCAL YEARS 14 AND 15 AND PMIIS RELATIVELY NEW. SO YOU WON'T SEE REFERENCE FOR PMIIN THIS DOCUMENT. USE OF OT AUTHORITY HERE AT THE NIH IS RELATIVELY NEW. CURRENTLY, THERE ARE ONLY THREE ACTIVE O.T. OPPORTUNITIES OUT, ONE OF THEM BEING SPARK AND JIM, I DON'T KNOW FUN THE TO REFERENCE SPARK IN ANY WAY. IT'S VERY A GRANT LIKE MECHANISM, BEING WORKED THROUGH THE COMMON FUND. AND OUR TWO PMI, DIRECT VOLUNTEER PILOT AND ALSO, THE COMMUNICATION SUPPORT FOR THE PMI RESEARCH PROGRAM. IN ORDER TO USE OTHER TRANSACTION AUTHORITY, EACH AGENCY IS RESPONSIBLE FOR DEVELOPING POLICY SO HERE AT NIH THERE IS A POLICY GUIDE, SPECIFIC TO THE SPARK PROGRAM AND WE HAVE PUT TOGETHER A POLICY GUIDE FOR THE USE OF OTHER TRANSACTIONS WITH THE PMIPROGRAM. THESE LINKS ARE AVAILABLE TO TAKE YOU THROUGH THOSE SOLICITATIONS. IF YOU HAVEN'T READ THEM, YOU WILL BE THIS EVEN WHEN GWEN AS OUT YOUR HOMEWORK. WANT TO POINT YOU TO THE POLICY GUIDE. LISTED ON THE NIH PMIWEBSITE. IF YOU HAVE ANY QUESTIONS REGARDING HOW WE PLAN TO IMPLEMENT, TRANSACTION AUTHORITY FOR THE PMI PROGRAM. IN ADDITION TO THE FLEXIBILITY THAT THIS PERMANENT DIRECTORS, IN THE INITIAL AND NEW YORK OF THE TERMS AND AWARDS, IT IS THE MECHANISM IN WHICH THE GOVERNMENT DOES NOT COMMIT FUNDS FOR THE ENTIRE PROJECT THE GOVERNMENT COMMITS THE FUNDS AT SPECIFY INTERVALS, MAYBE ONCE A MONTH. SO IT IS FOR THE FEDERAL GOVERNMENT, MUCH LESS RISQUE, IN TERMS OF NOT GETTING WORK DONE THE A ONE EXPECTS SO EACH MONTHS, THERE COULD BE MILESTONE AND TASKS REPORTED AND THAT IS REPORTED IN THE NEXT FUNDINGS SO IT IS, AND I THINK FOR THE AGENCY THAT USE THIS, PARTICULARLY IN HIGH-TECH SETTINGS, IT REALLY HAS A LOT OF ADVANTAGES THE DOCUMENTS THAT DEB INDICATED, THE POLICY GUIDE, THIS WAS NOT A TRIVIAL URN TALKING TO PULL DOWN THE BACKGROUND AND REGULATORY INFORMATION TO CREATE THIS. BUT I THINK WE ARE MOVING INTO WAYS TO FUND WORK THAT CAN BE REALLY PERSONALITY IN THE FUTURE AND IS PART OF HOW WITHIN GOV SPEAK, THIS IS DISRUPTIV DISRUPTIVE >> IT'S LIKE THE LAWS OF GRAVITY HAVE BEEN REPEALED >> THE OTHER POINT TO MAKE ABOUT THIS, THE GOVERNMENT ACCOUNTING STARNS ARE VERY INTENSELY COMPLICATED SPECIFYINGS, AND MANY PRIVATE SECONDER ENTITIES ARE REALLY NOT INTERESTED IN PLAYING, IN TERMS OF GRANTS OR CONTRACTS BECAUSE OF ALL THE DETAIL OF THE REPORTING REQUIREMENTS. SO WE'RE GOING TO KNOW PRETTY WELL, HOW MONEY IS BEING SPENT. WE'RE GOING TO HAVE A GOOD HAN ON THAT. BUT THEY AREN'T GOING TO HAVE TO UTILIZE SOME VERY CLUNKY RESPECTING TOOL FOR HOW THE MONEY IS SPENT. WE THINK THIS IS GOING TO BE USEFUL AND A CHANGE AGENT. THE OTHER THING I WANTED TO MAKE SURE YOU HEAR BEFORE WE BREAK IS JUST A LITTLE BIT OF THE THINKING OF CONFLICT OF INTEREST ISSUES IN THE SETTING OF THIS STUDY, PARTICULARLY, CONFLICTS OF INTEREST THAT MAY ARISE ARE FOR YOU. SO GWEN OUR EXECUTIVE SECRETARY IS GOING TO HELP US TALK >> AND FOR THOSE WHO ARE WATCHING US ON ZOO CAST, MAYBE OUR VIDEO FOLKS CAN, FOR A MOMENT, SHOW -- OUR VIDEO CAST, CAN SHOW SEAT WEB SCENE. THIS IS PAGE THAT CONTAINS INFORMATION THAT WE CIRCULATED TO OUR WORKING GROUP MEMBERS. YOU CAN SEE ADVISORY COUNCILS OR BOARDS SO WE ARE, OF COURSE, A WORKING GROUP OF THE COUNSEL OF COUNCILS. SO WE ARE THE WORKING GROUP OF A COUNCIL. SO AS I CLEARLY, THERE ARE SOME VARIOUS OBVIOUS CONFLICTS OF INTERESTS, THAT PEOPLE WILL RECUSE THEMSELVES FROM SPECIFIC DECISIONS, IF YOU ARE A P.I. OR PMRIRB ON AN APPLYING THAT COMES IN, FOR EXAMPLE, OR HAVE ANOTHER REAL KIND OF BONA FIDE CONFLICT OF INTEREST. BUT AS YOU CAN SEE FROM THE GUIDANCE, ONSITING OBJECTIVITY. OTHER KINDS OF CONFLICTS THAT CAN BE FRONT OR AN APPEARANCE MUCH CONFLICTS, YOU KNOW, THE CENT OF THE NIH HAS BEEN THAT IN THE AGE OF PUSHES FOR BEING HIGHLY COLLABORATIVE AND FOR HAVING KIND OF, YOU KNOW, MANY RELATIONSHIPS WITH PEOPLE ACROSS INSTITUTIONS AND ACROSS SCIENTIFIC AREAS T BECOMES INCREASINGLY COMPLICATED FOR US AS AN EXTO, YOU KNOW, KIND OF PUSH ANYTHING THAT HAS AN PATIENCE OF CONFLICTS OUTSIDE OF THE ROOM SO PER THE GUIDANCE, THINGS LIKE SCIENTIFIC COMPETITION, THOSE ARE THINGS WE CAN DISCUSS AND DETERMINE WHETHER OR NOT THERE'S SUBJECT OBJECTIVITY TO BE MANAGED AND KEEP PEOPLE IN THE ROOM OR WHETHER OR NOT PEOPLE SHOULD BE RECUSED. THE SAME THING THOUGH, FOR COLLABORATIONS AND CONSULTATIONS FOR MENTOR-MEMENTEE RELATIONSHIPS. SOMEONE'S NAME APPEARS ON THE AUTHOR LINE. DOESN'T NECESSARILY MEAN THEY ARE IN A POSITION OF CONFLICT FOR A PARTICULAR APPLYING THAT COMES IN FOR SOMEONE ELSE, ON GOING PROFESSIONAL COMMITS, ET CETERA. WE ARE ALSO APPROACHING, BRINGING THE SAME SENSIBILITY TO APPLICATION THAT IS COME IN THE INSTITUTION OF INDIVIDUAL PANEL MEMBERS. PARTICULAR UNIVERSITIES DOESN'T MEAN YOU'RE FUNDAMENTALLY IN CONFLICT WITH AN APPLICATION THAT COMES FROM ANOTHER AREA. THOSE ARE THINGS WE'LL ISSUE TALKING ABOUT AS AN INITIATIVE IN DEALING WITH. HOPEFULLY, EVERYONE HAD A CHANCE TO LOOK AT GOVERNANCE PROVIDED. DOES ANYONE HAVE ANY QUESTION AT THIS TIME? >> I THINK YOU'VE SUMMARIZED IT, TOO LOOK AT THAT DOCUMENT. IF YOU HAVE QUESTIONS ABOUT YOUR RELATIONSHIP WITH SPECIFIC APPLICANTS SHE'LL TALK YOU THROUGH IT, AND WE'LL ATTEMPT WHICH MIGHT CREATE EITHER REAL OR APPEARANCE OF CONFLICT BUT AT THE SAME TIME, WE NEED AN ACTIVE ADVISORY GROUP AND I WANTED TO MAKE SURE THAT WE FORMULATE THIS, THAT MOST OF THE QUESTIONS I ANTICIPATE DISCUSSING IN OPEN SEGREGATED, WILL NOT POSE CONFLICT OF INTEREST BECAUSE THEY ARE NOT ABOUT THE DETAILS OF SPECIFIC APPLICATIONS. GWEN WILL BE OUR LEAD PERSON TO CONSULT ON THESE MATTERS. ANY QUESTIONS ABOUT THAT. IF NOT, I THINK WE ARE EXACTLY ON TIME. >> CAN WE JUST ASK WHO'S ON THE PHONE. WHO DO WE HAVE ON TELECONFERENCE AT THIS TIME? >> ERIC IS STILL HERE >> GREAT. ERIC DISHMAN. DO WE HAVE [OVERLAPPING SPEAKERS] >> WE HAVE GOT ROB. MIKE IN THE ROOM. OKAY. ANYONE ELSE? [INDISCERNIBLE] >> PARDON ME? >> AND BOTH MY DOGS, JUST SO YOU KNOW. [LAUGHTER] >> THEY MIGHT HAVE TO BE RECUSED, ERIC, I'M NOT SURE. SO GREAT. TY, AT 2:30. SO IN JUST A COUPLE OF MINUTES, VIDEO CAST IS GOING TO BE GOING DOWN, WE'RE GOING TO ENTER INTO, I THINK A 17-MINUTE BREAK OR SO. WE'LL COME BACK AND RESTART PRECISELY AT 2:45 IN CLOSED SESSION. SO FOR FOLKS, FOR ERIC WHO'S ON THE PHONE, PLEASE STAY TUNED. WE'LL BE USING THE SAME NUMBER. THANK YOU.