I WOULD LIKE TO CALL TO ORDER THE 87TH MEETING OF THE NATIONAL ARTHRITIS AND MUSCULO HE WILL TALL AND SKIN DISEASES ADVISORY COUNCIL. I WANT TO WELCOME NOT ONLY OUR COUNCIL MEMBERS AND GUESTS WHO ARE HERE BUT ALSO ANY WHO ARE VIEWING ON THE VIDEOCAST. THIS VIDEOCAST WILL BE AVAILABLE FOR SIX MONTHS. WE DECIDED TO DO THIS AT OUR LAST MEETING, SOME OF THE OTHER COUNCILS HAVE DONE THIS AND THE WAY I FOUND OUT ABOUT IT FRANKLY WAS BECAUSE I WAS HAVING LUNCH AT A -- VISITED A TRAINING PROGRAM FOR MUSCLE BIOLOGISTS AT THE UNIVERSITY OF MARYLAND, A BIG TRAINING PROGRAM. SOMEBODY WAS COMPLAINING ABOUT AT ONE OF THE OTHER INSTITUTES, I WON'T SAY WHICH ONE. HOW WOULD YOU KNOW THAT WENT ON AT THE COUNCIL MEET TODAY, DID THEY GO INTO GREAT DETAIL IN THE MINUTES? HE SAID OH, NO, I WATCH IT ON THE VIDEOCAST. SO I THINK IN WITH ALL THE OTHER THINGS THAT WE DO REGARDING TRANSPARENCY, THIS IS NATURAL TO DO THIS LIVE. WE HAVE TWO PEOPLE ON THE PHONE. CLIFF ROSEN AND ALEX SILVER, WELCOME BOTH OF YOU. >> THANK YOU. >> CLIFF AS YOU KNOW IS A FORMER COUNCIL MEMBER AND I HAVE ASKED HIM PARTICULARLY TO COMMENT ON OUR EFFORTS IN TERMS OF CLINICAL RESEARCH. HE'S BEEN CHAIRING OUR INTERNAL AMS CLINICAL STUDY SECTION. WE'RE WAITING FOR ELIZABETH SHANE WHO WILL -- IS ELIZABETH ON? >> YES, I AM. >> HI, ELIZABETH. >> HI. >> GOOD TO HAVE YOU ON THE PHONE. WITH US. >> I JUST NEED TO ASK YOU TO DO ONE THING, ELIZABETH. IF YOU'RE ALSO WATCHING THE VIDEOCAST PLEASE MUTE YOUR COMPUTE SORE WE DON'T GET AN ECHO THROUGH THE PHONE. >> I THINK IT'S MUTED. >> GREAT. >> YOU ELIZABETH AND ALEX CAN CERTAINLY AND CLIFF CAN CERTAINLY PARTICIPATE IN THE DISCUSSIONS NOT THROUGH THE VIDEO BUT THROUGH YOUR PHONES. >> OKAY. >> COUNCIL MEETINGS ARE OPEN TO THE GENERAL PUBLIC AS REQUIRED BY PUBLIC LAW 92-463, THE CLOSED PORTION OF THE MEETING IS CLOSED FOR REVIEW DISCUSSION EVALUATION OF INDIVIDUAL GRANT APPLICATIONS IN ACCORDANCE WITH CERTAIN PROVISIONSES OF THE U.S. CODE. YOUR FOLDERS CONTAIN STATEMENTS REGARDING CONFLICTS OF INTEREST YOU MUST SIGN AND RETURN TO DOUG MULLIN. PLEASE TAKE A MOMENT MOW TO FIND THAT STATEMENT READ SIGN IT AND PASS IT TO THE HEAD OF THE TABLE. >> PASS THAT SIGN IN SHEET TOO WHEN YOU DO THAT. SO WE WANT TO CONSIDER THE MINUTES, THERE WAS ONE SMALL POINT THAT WAS BROUGHT UP AT THE -- IN TERMS OF THE MINUTES CHANGE. IT'S FAR FROM SUBSTANTIVE BUT WE WANT IT CORRECT AND WE APPRECIATE THE COUNCIL REVIEW OF THE MINUTES AND WE ARE AWARE OF THAT AND LAURA IS CHANGING THE MINUTES IN TERMS OF DR. RANKIN'S PARTICIPATION AT THE LAST MEETING WHICH HE DID PARTICIPATE IN WITH JUST THE CLOSED SESSION. THEN SOME HOUSEKEEPING. >> I WANTED TO REMIND YOU THE NEW CONFLICT OF INTEREST REPORTING DATES, THE NEXT REPORTING DATE IS GOING TO BE OCTOBER 2ND. THAT'S -- THAT SEEMS A LONG WAY FROM NOW BUT IT'S NOT THAT FAR. YOU MUST RESPOND WITHIN 30 DAYS TO PARTICIPATE IN FUTURE COUNCIL BUSINESS SO PLEASE BE ATTENTIVE TO THAT REMINDER WHEN YOU GET IT. IF YOU HAVE CHANGED YOUR FLIGHTS, PLEASE LET PAM KNOW OR IF YOU WANT TO MAKE CHANGES IN YOUR FLIGHTS FOR RETURNING THIS AFTERNOON, LET HER KNOW SO SHE CAN TAKE CARE OF THAT FOR YOU. THANKS. >> I HAVE TO VOTE ON THE MINUTES. ALL IN FAVOR. NONE OPPOSED P. I'LL GO ON TO MY REMARKS I WANT TO THANK YOU ALL AGAIN FOR BEING HERE, ESPECIALLY AFTER A LONG WEEKEND, THE NEXT TWO YEARS WE'RE NOT GOING TO HAVE THE SAME THING THOUGH THERE'S NOTED IN FUTURE COUNCIL MEETINGS. THE MEETINGS FROM THE CALENDAR, IT'S WEDNESDAY, NOT ON A TUESDAY. BUT I DO APPRECIATE GREATLY PARTICULARLY THOSE WHO TRAVEL VERY FAR, AND EVEN WHEN IT CAME TO THE LAST MEETING THOSE WHO TRAVEL NOT FAR WAS A DIFFICULT THING IN TERMS OF GETTING HERE BUT I DO APPRECIATE YOUR VERY MUCH YOUR COMMITMENT TO THE MEETING AND CLIFF I WANT TO SAY I THANK YOU, VERY MUCH FOR BEING ON THE PHONE THIS MORNING. I KNOW THERE ARE SEVERAL THINGS THAT YOU CAN CONTRIBUTE TO SO I APPRECIATE YOUR PARTICIPATION. THE DEPARTING COUNCIL MEMBERS TAKE NOTE. WE CALL UPON OUR PAST COUNCIL MEMBERS FOR ADVICE, I THINK THAT YOUR KNOWLEDGE OF HOW THE COUNCIL WORKS AND WHAT I'M LOOKING FOR, THE CANDOR I'M LOOKING FOR IS IMPORTANT AND CERTAINLY I KNOW CLIFF CAN ATTEST TO THAT. AS I WENT AROUND THE TABLE I WAS AMAZED THAT FOUR YEARS HAD PASSED PERHAPS NOT AS AMAZED AS SOME OF YOU BUT PASS QUICKLY, O SIGNS FEY WANING JOINED THE COUNCIL. WE'RE GRATEFUL FOR THE GROUPs DELIBERATIONS. WE WILL HAVE A PLAQUE AND SOME PICTURES TAKEN AT THE BREAK. THIS MORNING I WILL TOUCH THREE BROAD AREAS IN MY DIRECTOR'S REPORT. I WILL TALK ABOUT AN UPDATE ON THE BUDGET AND CONGRESSIONAL ACTIONS. BACK TODAY BY THE WAY IF THERE'S A LOT OF TRAFFIC YOU KNOW WHY. AN OVERVIEW -- WATCH WHAT I SAY NOW WE'RE ON VIDEOCAST. I WILL PROVIDE AN OVERVIEW OF NIH AND NIMS ACTIVITIES AND PLANS AND HIGHLIGHT SELECTED RECENT ADVANCES. FIRST WITH THE UPDATE ON THE BUDGET AND CONGRESSIONAL ACTIVITIES. ON OCTOBER 1st THE FEDERAL GOVERNMENT WILL BEGIN THE NEW FISCAL YEAR, WE HOPE. WE ANTICIPATE BEGINNING OF FISCAL YEAR 2016 WITH A CONTINUED RESOLUTION. THAT'S THE CURRENT THOUGHT. AS JUST AS AN ASIDE ADRIENNE HALLETT IS COMING LATER, SHE IS OUR LEGISLATIVE LIAISON. SHE HAS A BIGGER TITLE THAN THAT FROM THE NIH TO THE CONGRESS, YOU CAN ASK HER MORE ABOUT THIS WHEN SHE'S HERE. THE DETAILS WILL BE CLARIFIED IN THE LEGISLATION THE CONTINUED RESOLUTION WILL MEAN THE NIH CONTINUES AT THE CURRENT BUDGET OR A LITTLE LOWER BUDGET. HOWEVER, IF IF YOU LOOK AT THE SLIDE, YOU CAN SEE THAT THE PRESIDENT'S BUDGET AND SENATE BUDGET IS -- AND ALSO THE HOUSE BUDGET IS WAY OVER EXPECTED INTEREST IN INCREASING THE NIH BUDGET FOR FISCAL YEAR 2016. IN KEEPING WITH OUR POLICY AT THE NIMS TRANSPARENCY WE WILL POST OUR FISCAL YEAR 2016 INTERIM PAY LINES AS SOON AS AVAILABLE BUT NOT BEFORE WE HAVE A BUDGET. SO WE HOPE IT WILL BE A SHORT TERM CONTINUING RESOLUTION. ONCE WE GET A CONTINUING RESOLUTION, ONCE WE WORK WITH OUR BUDGET OFFICE IN TERMS OF KNOWING WHERE WE ARE IN TERMS OF OUR APPLICATION PROCESS, THEN WE PUT UP OUR PAY LINES AND I HOPE THAT EVERYONE HERE AND ANYBODY LOOK ON KNOWS THAT THOSE GO UP RIGHT AWAY ONCE WE MAKE A DECISION. AS MANY OF YOU KNOW THE INSTITUTE RESERVES A PORTION FOR PROJECTS THAT ADDRESS SUBJECTS OF PARTICULAR RELEVANCE TO THE INSTITUTE SCIENTIFIC HEALTH PRIORITIES EVEN IF ASSIGNED SCORES AND PERCENT TALL RANKINGS WOULDN'T QUALIFY UNDER THE CURRENT PAY LINES. THERE'S NO P APPLICATION PROCESS FOR THIS TYPE OF SELECT FUNDING. SUGGESTIONS COME FROM NIMS STAFF AND WE WELCOME COUNCIL MEMBERS INPUT ON SUGGESTIONS IN THIS AREA. THE SELECT PAY PROCESS IS DESCRIBED ON OUR WEBSITE AS A CHART DEPICTING NUMBER OF RO-1 APPLICATIONS JUST FOR RO-1 APPLICATIONS YOU SEE THAT NICSMS RECEIVED AND FUNDED IN FISCAL YEAR 2014. WE DON'T HAVE THE DATA YET FOR 2015. AS A FUNCTION OF THE SCORES THE APPLICATIONS RECEIVED DURING THE PEER REVIEW PROCESS SO YOU CAN SEE BEYOND PAY LINE WE NOT ONLY PAY NEW INVESTIGATORS WE HAVE A NEW INVESTIGATOR PAY LINE BUT ALSO WITHIN HERE THERE ARE OTHER APPLICATIONS THAT ARE NOT NEW OR EARLY STAGE INVESTIGATORS. IT SHOULD BE NOTED AS YOU RECALL THAT WE RECEIVE APPLICATION OF LOW PROGRAM PRIORITY AND WITH COUNCIL'S RECOMMENDATION WE DON'T FUND SUCH APPLICATIONS. ALSO PLEASE AS I SHOWED YOU ON THAT SLIDE WE HAVE A DIFFERENTIAL PAY LINE FOR NEW EXPERIENCE AND NEW INVESTIGATORS AND WHAT WE -- WHAT THE GOAL HERE AT NIH HAS BEEN FOR THE LAST FEW YEARS, IS THAT THE SUCCESS RATE FOR NEW APPLICATIONS FROM EXPERIENCE -- THIS SLIDE DOESN'T SHOW BUT SUCCESS RATE FROM NEW EXPERIENCED INVESTIGATORS FOR NEW APPLICATIONS IS SAME AS SUCCESS RATE FOR NEW INVESTIGATORS. AND WE HAVE BEEN PRETTY CLOSE MOST YEARS, THIS YEAR THE SUCCESS RATE IS HIGHER FOR NEW INVESTIGATORS THAN EXPERIENCED INVESTIGATORS APPLYING FOR NEW APPLICATIONS BUT NOT A SURPRISE THE SUCCESS RATE WOULD NOT BE THE SAME FOR BOTH GROUP BECAUSE ONE GROUP HAS BEEN IN THE BUSINESS FOR LONGER AND SUCCESS RATE FOR TYPE 2 APPLICATIONS OR RENEWAL APPLICATIONS ARE MUCH GREATER. TAKE THAT SLIDE OFF, THANK YOU. SO THE HOUSE AND SENATE BOTH INTERESTED IN THE NIH STRATEGIC PLAN AND PRIORITY SETTING PROCESS HOW TO MAKE SELECT DECISIONS. WE RECEIVE QUESTIONS FROM SEVERAL MEMBERS OF CONGRESS DURING RECENT YEARS AND THE CONGRESS ASKED NIH TO DEVELOP A FORMAL STRATEGIC PLAN AS PART OF THE FISCAL YEAR APPROPRIATION BILL. IN JUNE I MENTIONED THE NIH ADVISORY COMMITTEE TO THE DIRECTOR DISCUSSED EARLIER VERSION OF THE PLAN IN DEPTH AND YOU WILL ALSO HEAR THAT THE 21st CENTURY CURES ACT THERE'S FURTHER DISCUSSION ABOUT STRATEGIC PLAN. TODAY WE HAVE INVITED THE NIH PRINCIPLE DEPUTY DIRECTOR LARRY TABAK TO TELL YOU MORE ABOUT NUMBER ONE, NIH EFFORTS TO DEVELOP A PLAN TO FULFILL THE REQUIREMENTS TO ATTENTION WHILE MAINTAINING THE RESEARCH COMMUNITIES FLEXIBILITY TO RESPOND TO EMERGING SCIENTIFIC OPPORTUNITIES. I KNOW LARRY WOULD APPRECIATE GREATLY YOUR INPUT AND ACTIVE PARTICIPATION SO FEEL FREE, HE WILL BE HERE AT 10:30. HE IS MAKING TWO PRESENTATIONS, HE'S ALSO GOING TO UPDATE US ON WHAT'S CALLED ECHO, AN ACRONYM FOR ENVIRONMENTAL INFLUENCES ON CHILD HEALTH OUTCOMES PROGRAM. WHICH THE NIH IS DEVELOPING TO ACCOMPLISH THE SPECIFIC GOALS OF THE NATIONAL CHILDREN'S STUDY. HE WILL TELL YOU HOW THE CHILDREN'S -- THE CHILDREN'S STUDY THAT WAS STARTED IN EARLY 2000s IS -- WAS STOP AND HOW WE MOVE FORWARD TRYING TO ADDRESS THOSE SPECIFIC AIMS. ANOTHER AGENERAL DA ITEM IS PRIORITY -- AGENDA ITEM IS PRIORITY SETTING, CURES EFFORT IN THE HOUSE LED BY REPRESENTATIVES FRED UPTON AND DIANE DEGET PASSED THE HOUSE BY A VOTE OF 350 TO WHATEVER. TO ACCELERATE THE DISCOVERY DEVELOPMENT AND DELIVERY OF TREATMENT IN CURES FOR DISEASE. WE INVITED DR. HALLETT, NIH ASSOCIATE DIRECTOR FOR LEGISLATIVE POLICY, THAT WAS WHAT I WAS LOOKING FOR AND ANALYSIS TO PROVIDE UPDATE OF THAT 21st CENTURY CURES ACT THAT MIGHT BE OF INTEREST TO Y'ALL THOUGH NOT IN EFFECT, IT'S WAITING TO BE IN EFFECT AND WAIT ING FOR SENATE RECONCILIATION BETWEEN SENATE AND HOUSE SENATE BILL CALLED INNOVATION FOR HEALTHIER AMERICANS INITIATIVE. SHE H TALK ABOUT THAT. WE APPRECIATE THE OPPORTUNITIES TO EDUCATE MEMBERS OF CONGRESS ABOUT THE NIH, THE NIMS AND IMPORTANCE OF THE WORK THAT WE SUPPORT. SINCE WE HAVE ASKED PARTICIPATED A SERIES OF COURTESY VISITS ORGANIZED BY AMERICAN ACADEMY OF DERMATOLOGY ASSOCIATION. THESE SOME OF THE -- THESE ARE SOME OF THE PICTURES THAT ARE TAKEN WITH THIS IS WITH SENATOR CASSIDY BUT I MET WITH MARK LEDWALL AADA PRESIDENT, I SPENT A FULL DAY ON CAPITOL HILL MEETING WITH RICHARD DURBID JACK KENNEDY AND CHUCK FLIESMAN FROM TENNESSEE. VERY INTERESTED IN WHAT GOES ON AT NIH, AT LEAST IT'S MY PERCEPTION, MAYBE A MISPERCEPTION BUT THEY'RE INTERESTED IN WHAT GOES ON HERE, PEOPLE ARE INTERESTED IN HEALTH. THAT'S WHAT SORT OF BINDS US ALL TOGETHER. IT'S A BIPARTISAN THING. IT'S A RATHER HI SRI EXPERIENCE TO -- HEAVY EXPERIENCE BECAUSE EVERYBODY IS FOR IT, QUESTION IS HOW TO GET THERE, HOW TO FINALLY GET THERE. THEY WERE INTERESTED IN HOW NIH FUNDED RESEARCH CONTRIBUTES NEW TREATMENTS, THE COST OF THESE NEW TREATMENTS WAYS TO SPEED THE DEVELOPMENT PROCESS, SENATOR D DURBIN ASKED THE ACCELERATING MEDICINES PARTNERSHIP FOR RA LUPUS WHICH CONTINUES TO MAKE PROGRESS TOWARDS TRANSITIONING TO PHASE 1, AN EFFORT BEING LED BY BOB CARTER AND SUSANA SERRATE-SZTEIN, AND MICHAEL HOLLIS PLAYING A CRITICAL ROLE IN LEADING TO ITS SUCCESS. SENATOR CASSIDY I MENTIONED IN A PICTURE IS A GASTROENTEROLOGIST FROM LOUISIANA. A MEMBER INTERESTED IN NIH PRIORITY SETTING, VIS-A-VIS HIV AND AIDS. AND WHAT WE'RE DOING IN THAT RESEARCH RELATIVE TO OTHER PUBLIC HEALTH ISSUES. AS I MENTIONED IN JUNE, THE NIH IS SEARCHING FOR NEW ASSOCIATE DIRECT TO FOR AIDS RESEARCH, FOLLOWING JACK WHITECARVER'S RETIREMENT AT THE BEING OF JULY. I SHOULD MENTION SHOWING THIS SLIDE, THAT WE DO HAVE A NEW TRANS-NIH PLAN FOR HIV, RELATED RESEARCH. AND THE PLAN HAS BEEN SET NOT ONLY BY THEIR ADVISORY COUNCIL BUT ALSO BY THE DIRECTORS AND ANYONE INTERESTED SHOULD TAKE NOTE OF THIS PUBLISHED NOTICE IN THE NIH GUIDE FOR RESEARCH AND GRANTS THAT SPELLS OUTS THE FISCAL YEAR 2016 PLANS. WE DO SOME HIV RELATED RESEARCH AS YOU CAN IMAGINE MANY OF OUR DISEASES ARE CHRONIC DISEASES AND NOW WHAT WE SEE WITH THE CHRONICITY OF PATIENTS WITH AIDS LIVING LONGER, THEY HAVE MANY OF THE PROBLEMS THAT WE DEAL WITH. WHETHER IT'S LIPODYSTROPHY, WHETHER IT'S OSTEOPOROSIS. ALL THESE THINGS ARE -- THEY SORT OF NOW INTERSECT INTO OUR SPHERE OF PARTICULAR INTEREST. I WAS ABLE TO TALK TO REPRESENTATIVE CHARLIE DENT ABOUT OUR COMMITMENT TO SUPPORTING YOUNG INVESTIGATORS INCLUDING OUR NEW SUPPLEMENTS TO ADVANCE RESEARCH, THE STAR PROGRAM FROM PROJECT TO PROGRAMS AWARDS, AS YOU WILL RECALL WE AWARDED THREE OF THEM AT OUR LAST SESSION. AND THE STAR PROGRAM WE HAVE DISCUSSED HERE, AND WE HAVE MADE THOSE AWARDS TO DR. MULLLY, DR. CHOW AND DR. YANG. THESE ARE THE FIRST THREE STAR AWARDEES. JUST SO YOU KNOW OUR APPLICATION PROCESS IS TWICE A YEAR. NOT THREE TIME AS YEAR, SO THE TWICE A YEAR YOU WILL SEE OTHER APPLICATIONS COME IN FOR THE FEBRUARY COUNCIL PERSONNEL CHANGES AT THE NIH AND NICSMS, -- NIMS. DR. ALAN GUTTMACHER ANNOUNCED LAST MONTHS HE IS GOING TO RETIRE AT THE DIRECTOR OF THE EUGENE KENNEDY SHRIVER NATIONAL CHILD HEALTH AND HUMAN DEVELOPMENT. DR. SPONG WILL SERVE AS ACTING DIRECTOR. DR. RILEY IS NEW OFFICE OF BEHAVIORAL AND SOCIAL SCIENCE RESEARCH. WE HAVE INTERACTED WITH HIM A FAIR AMOUNT OVER THE YEARS. HE'S WORKED IN SEVERAL OTHER INSTITUTES. WITHIN OUR OWN INSTITUTE WE HAVE HIRED DR. TOM CHEEVER AS AN NIMS PROGRAM DIRECTOR, TOM, IS TOM HERE? STAND UP, TOM. TOM IS SCIENTIST WITH STRONG SCIENTIFIC BACKGROUND NEURO MUSCULAR BIOLOGY SPINAL MUSCULAR ASTRO FEW AND MUSCULAR DYSTROPHY AND WILL MANAGE MUSCLE DISORDERS AND THERAPIES PROGRAM AND HE COMES TO US FROM NINDS. SO WE HAVE MADE TRAITS -- I HATE TO USE BASEBALL ANALOGIES BUT WE MADE SOME TRADES, WE HAVE A COUPLE OF HUNDRED THOUSAND DOLLARS IN ADDITION TO TOM CHEEVER. WELCOME, TOM. SOMETIMES WE DON'T HAVE TO TRADE BECAUSE WE HAVE PEOPLE COMING UP AND WE WELCOME DR. YEN LU. OR NEWEST SCIENTIFIC REVIEW OFFICER. HE COMES TO US FROM THE NIMS INTRAMURAL RESEARCH PROGRAM, WHERE HE SERVE AS STAFF SCIENTIST AND TRANSLATIONAL PRIOR TO JOINING THE PROGRAM TO EXPERIMENTAL IMMUNOLOGY BRANCH. SO WELCOME. DR. LU. THE VAST MAJORITY OF NIMS BUDGET SUPPORTS INVESTIGATOR INITIATED RESEARCH PROJECTS REVIEWED THROUGH THE NIH CENTER FOR SCIENTIFIC REVIEW, WE SCAN THE SCIENTIFIC LANDSCAPE FOR AREA ACTIVITIES RIPE FOR INVESTMENT BUT NOT BEING PURSUED THROUGH THE REGULAR UNSOLICITED GRANT PROCESS. WE WILL SPEND TIME LATER THIS MORNING TALKING INITIATIVES WE ARE CONSIDERING. NOT THAT WE DO BUT ARE CONSIDERING FOR FISCAL YEAR 2017 TO PROMOTE RESEARCH IN ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES. THE NEXT SLIDE. AT THE END OF MY REMARKS, I WILL COME BACK TO THIS. I WANT TO DISCUSS -- GET YOUR THOUGHTS ON EXISTING SUITE OF CLINICAL RESEARCH INITIATIVES AND ON OUR NEW APPROACHES THAT WE CONSIDER TO ENCOURAGE THE CLINICAL RESEARCH COMMUNITY. TO SEND BEST IDEAS FOR HIGH QUALITY HIGH IMPACT CLINICAL TRIALS THAT ARE LIKELY TO CHANGE CLINICAL PRACTICE. THIS DEPICTS SOME OF WHAT THOSE -- WHAT THAT MENU IS FOR CLINICAL TRIALS AND WHAT WE GET IN CLINICAL TRIAL WE EXPECT TO SEE CLINICAL TRIAL EXPLORATORY CLINICAL TRIAL OR CLINICAL OBSERVATION STUDY THAT WILL LEAD TO THE ONSET OF CLINICAL TRIAL. THIS LEADS TO TWO THINGS, NOT ONLY WHAT WE'RE DOING BUT ALSO IN A FEW MINUTES I'LL TALK PROPOSED CHANGES TO THE COMMON RULE WHICH ALSO AFFECT CLINICAL TRIALS. THE CURRENT CLINICAL TRIALS PATHWAY WHICH IS DEPICTED HERE, EMERGE WHEN WE EXAMINE THE ISSUE FIVE YEARS AGO, WE TALKED ABOUT H THIS, I THINK DURING HIS COUNCIL'S LIFETIME. AT THE SAME TIME WE FORMED A DEDICATED STUDY SECTION FOR REVIEW OF APPLICATIONS SUBMITTED UNDER THESE INITIATIVES. AND ESTABLISHED A WORK GROUP OF COUNCIL TO ADVISE US ON THE LATEST REQUEST INVESTIGATORS SUBMIT TO NIMS IN ADVANCE OF THEIR APPLICATIONS. THE REASON I ASK CLIFF TO BE ON THIS CALL IS HE HAS CHAIRED THIS DEDICATED STUDY SECTION NIMS AND I WOULD LIKE TO GIVE HIS PERSPECTIVES ON THAT. AS A START TO THE DISCUSSION WE WILL HAVE AT THE END OF MY REMARKS. FIVE YEARS LATER WE ASKED THE FOLLOWING QUESTION AS PART OF ONGOING STEWARDSHIP RESPONSIBILITIES IN EXAMINING THE CLINICAL TRIALS. THIS IS BY THAT I SENT TO Y'ALL WAYS OUR SUITE OF CLINICAL TRIAL APPLICATIONS AND FUNDING OPPORTUNITY ANNOUNCEMENTS CAN BE APPROVED UPON, TO ADEQUATELY PROVIDE OPPORTUNITIES FOR ALL TYPES OF CLINICAL TRIALS. NUMBER ONE, NECESSARY TO SUPPORT DIFFERENT STAGES OF CLINICAL TRIAL PRESENTATION, WAYS TO OPTIMIZE THE EARLY REVIEW OF THE CONCEPT OF FUTURE CLINICAL TRIAL AND OTHER AREAS SEEN AS RELEVANT TO THE OPTIMIZATION OF NIH-SUPPORTED CLINICAL TRIALS. I'LL PUT THIS SLIDE BACK UP AT THE END OF MY TALK SO WE CAN HAVE A BRIEF DISCUSSION THAT FOCUSES JUST ON THAT. A BRIEF NOT SO BRIEF. THANK YOU. ALSO RELEVANT AS I MENTIONED ALSO RELEVANT TO CLINICAL RESEARCH, CONSIDER THE WORK DR. CATHY HUDSON HAS BEEN DOING FOR MANY YEARS TO UPDATE THE COMMON RULE FOR THE PROTECTION OF HUMAN SUBJECTS RESEARCH. I MUST ADMIT THAT I HEARD THE TERM COMMON RULE FOR MANY YEARS AND I THOUGHT IT WAS JUST A COMMON RULE BUT THE COMMON RULE -- THE COMMON RULE BECAUSE MANY AGENCIES AND GOVERNMENT HAVE AGREED TO IT. SO IT'S COMMON ACROSS THE GOVERNMENT. EVERYBODY ELSE KNEW THAT BUT I DIDN'T KNOW THAT. THE CURRENT REGULATIONS WHICH HAVE BEEN IN PLACE SINCE 1991 DEVELOPED AT A TIME WHEN RESEARCH WAS PREDOMINANTLY CONDUCTED AT MEDICAL INSTITUTIONS, EACH STUDY GENERALLY TOOK PLACE IN -- TIMES HAVE CHANGED. WE KNOW THAT. EXPANSION OF RESEARCH SCIENTIFIC DISCIPLINES GENOMICS ALONG WITH INCREASE IN MULTI-SITE CYSTOIDS SIGNIFICANT ADVANCES IN TECHNOLOGY HIGHLIGHTED THE NEED TO UPDATE REGULATORY FRAMEWORK. NOTABLY MORE PARTICIPATORY MODEL OF RESEARCH IS ALSO EMERGED. WITH INDIVIDUALS LOOKING FOR MORE RESEARCH ENTERPRISE. THOSE WHO ARE ON COUNCIL LAST SEPTEMBER REMEMBER DR. HUSSON'S PRESENTATION WHERE SHE DESCRIBED THE ADVANCE NOTICE OF PROPOSED RULE MAKING. THAT INCLUDED KEY REFORMS LIKE -- I THINK THOSE OF YOU WHO DO CLINICAL RESEARCH RESONATE TO THOSE WHO DON'T -- CAN APPRECIATE I THINK THE SIMPLIFIED CONSENT DOCUMENTS, TO CALIBRATE OVERSIGHT TO LEVEL OF RISK. INCREASE PRIVACY AND SECURITY SAFEGUARDS FOR RESEARCH WITH BIOSPECIMENS AND DATA. SO THEY BROAD PARTICIPATION IN RESEARCH AND STREAMLINE THE IRB REVIEW. SO THOSE ARE THINGS THAT REALLY NEED FIXING AND NEED FIXING AND WE HAVE NOW MOVED ON TO THE NEXT STAGE WHICH IS SHOWN HERE ON THIS SLIDE, THE DEPARTMENT OF HEALTH AND HUMAN SERVICES HAS ADDRESSED THE INPUT IT RECEIVED, TODAY PUBLISHED UPDATED PROPOSAL IN THE FORM OF NOTICE OF PROPOSED RULE MAKING, EVERYTHING HAS AN ACRONYM IN THE GOVERNMENT, THIS IS THE NPRM, THE NOTICE OF PROPOSED RULE MAKING. AND THE UPDATED COMMON RULE WOULD APPLY TO ALL CLINICAL TRIALS REGARDLESS OF FUNDING SOURCE IF THEY CONDUCTED IN THE U.S. INSTITUTION THAT RECEIVES FUNDING FOR RESEARCH INVOLVING HUMAN PARTICIPANTS FROM A COMMON RULE AGENCY. SO ANYTHING THAT'S BEING SUPPORTED BY GOVERNMENT AGENCY IS NOT ONLY THOSE STUDIES BUT STUDIES ARE SUPPORTED BY AN AGENCY THE PLACE THEY'RE SUPPORTED HAVE TO ABIDE BY THE COMMON RULE. SO WE URGE YOU, YOUR INSTITUTION AND PROFESSIONAL SOCIETIES BY YOU'RE INVOLVED TO PROVIDE POLICY AND PROVIDE ANY COMMENTS WITHIN 90 DAYS. INTERESTING TO KNOW FROM THOSE WHO DEANS OR DEANS OF RESEARCH TO KNOW WHAT THE IMPACT IS ON THESE THINGS AND HOW CLOSELY UNIVERSITIES FOLLOWING THIS ACTIVITY, I PERSONALLY WOULD BE INTERESTED IN KNOWING THAT. I THINK FROM HUDSON IS INTERESTED AS WELL. THE NIH IS PROUD TO SUPPORT PARTICIPATE IN MANY TRANS-NIH PROGRAMS AND THANK THE MANY STAFF MEMBERS WHO HAVE CONTRIBUTED TO THESE EFFORTS. ONE OF THE EFFORTS WHICH IS A TREAT YOU WILL HEAR ABOUT THIS MORNING, AS I MENTIONED DURING THE JUNE MEETING DR. JOAN MCGOWAN WHO WILL TELL US A NEW NIH COMMON FUND PROGRAM TO EXTENSIVELY CATALOG THE BIOLOGICAL MOLECULES AFFECTED BY PHYSICAL ACTIVITY IN PEOPLE. JOAN AND TEAM HAVE BEEN WORKING ON THIS FOR THREE YEARS. SO THAT HAS BEEN THE INCUBATION PERIOD, A MASSIVE EFFORT, THE EFFORTS HAS BEEN ALONG WITH OUR COLLEAGUES IN NATIONAL INSTITUTE DIABETES AND SUGGESTIVE DISEASE AND AGING BUT ALSO REPRESENTATIVES WHO BASICALLY ALL INSTITUTES AND CENTERS HAVE BEEN INTERESTED IN MOVING THIS EFFORT FORWARD. IT'S -- THIS IS A MULTI-INSTITUTE ENDEAVOR AND HAS BEEN ANNOUNCED IN FACT THE SCIENTIFIC COMMUNITY IS WELL-POSITIONED TO TAKE ADVANTAGE OF A COORDINATING EFFORT IN THIS AREA AS EVIDENCED BY A PLENARY SESSION SCHEDULE FORD THIS YEAR'S ANNUAL MEETING BY DR. BRUCE SPEAKELMAN WHO HAS BEEN HELPFUL IN TALKING ABOUT THESE ADVANCES THAT HAVE -- WHAT COULD COME AND WHAT THE OPPORTUNITIES ARE. HE'S SPEAKING AT -- AS I SAID THE ASBMR. SO WE WILL HEAR MORE ABOUT THIS WITH JOAN BUT IT IS A MASSIVE EFFORT, WE'RE HAPPY TO LEAD IT ADS ONE OF THE THREE INSTITUTES LEADING THE EFFORT. LATER YOU WILL HEAR FROM DR. SUSANNAH SERRATE-SZTEIN AND UPDATE YOU ON THE DEVELOPMENT OF ACTIVE PLAN FOR LUPUS RESEARCH, WE APPRECIATE THE FEEDBACK WE RECEIVED DURING THE PLANS DEVELOPMENT, WE USE THE WEBINARS TO A GREAT EXTENT TO HELP US WITH REGARD TO THIS FEED BACK, AS REMINDER WE'RE DEVELOPING THIS PLAN ON BEHALF OF THE ENTIRE NIH BECAUSE SO MANY INSTITUTES ARE INTERESTED IN LIEU PUS AND THEY HAVE A -- LUPUS AND THEY HAVE A STAKE IN LIEU PUS RESEARCH GOING FORWARDS. WE ALSO CONTINUE TO INCORPORATE PUBLIC FEEDBACK INTO OUR PLANS FOR THE PRESIDENT'S PRECISION MEDICINE INITIATIVE THAT SOME OF YOU HAVE HEARD ABOUT. P N IS A NATIONAL RESEARCH OF OVER 1 MILLION VOLUNTEERS, NOT YET DEFINED WHAT THIS PMI WILL BE. THIS SUMMER NIH LAUNCHED OTHER OUTREACH ACTIVITIES TO SHAPE THE COHORT GENETIC DATA DIET LIFESTYLE INFORMATION AND ELECTRONIC HEALTH RECORDS SO RESEARCH PUTS PRECISION MEDICINE INTO LARGE SCALE PRACTICE. YOU WILL HEAR MORE ANT THIS IN OUR FEBRUARY MEETING BECAUSE IT WILL BE BETTER OUTLINED AT THAT TIME. WE HAVE HAD A LONG STANDING COMMITMENT TO ENGAGING PATIENT COMMUNITIES AND OTHER MEMBERS OF PUBLIC IN OUR ACTIVITIES AND NOW WE WANT TO TALK ABOUT OUR COALITION OUTREACH AND EDUCATION DAY. WHICH WILL BE HELD OCTOBER 27th THIS YEAR. WE HOLD IT EVERY TWO YEARS. WE WILL HOST IT, IT'S THE NICSMS COALITION IS AN INDEPENDENT CONSORTIUM OF NATIONAL PROFESSIONAL VOLUNTARY ORGANIZATIONS COMMITTEE, RAISING AWARENESS ABOUT NIMS FUNDED RESEARCH, I KNOW DR. LEAH -- I KNOW LEAH HOWARD IS SOMETIMES HERE. CO-CHAIRS AND WE APPRECIATE THAT GREATLY, OUR OTHER CO-CHAIRS -- MARY WHEATLY, MAYBE ON THE VIDEOCAST AS WELL. MARY, WE APPRECIATE MARY, JUST COME ON AS CO-CHAIR AND WE APPRECIATE THAT RESPONSIBILITY. THESE MEETINGS PROVIDE A FORUM FOR COALITION MEMBERS TO SHARE BEST PRACTICES FOR CONNECTING SCIENCE TO THE PUBLIC WHILE GAINING A BETTER UNDERSTANDING OF HOW THE NIH WORKS. ALEX SILVER AGREED TO PARTICIPATE TO GIVE A SENSE OF BEST CASE SCENARIOS HOW TO DO THINGS B WE APPRECIATE ALEX VERY MUCH YOUR PARTICIPATION IN THAT MEETING. WE DO -- WE DON'T HAVE FACE TO FACE MEETINGS TWICE A YEAR WE DO HAVE PHONE MEETINGS OR WEBINARS TO BRING COALITION MEMBERS UP TO SPEED IN TERMS OF WHAT THE INSTITUTE IS DOING. WE JOINED A FEW COALITION PARTNERS AT THE NIH'S NATIONAL CENTER FOR COMPLIMENTARY AND HEALTH AND CDC TWITTER CHAT ABOUT ARTHRITIS. THE ABC NETWORKS CHIEF MEDICAL EDITOR DR. RICHARD BESSER HOSTED THE EVENT ESTIMATED TO REACH MORE THAN 600,000 TWITTER ACCOUNTS. WE'RE ALWAYS HAPPY TO FEATURE NIMS RESOURCES AND RESEARCH FINDINGS VIA SOCIAL MEDIA. SOME OF THE HIGHLIGHTS OF OUR INFORMATION DISSEMINATION EFFORT ARE NUMBER ONE FOR EXAMPLE THE MONTHLY LETTER THAT COMES OUT THIS MONTH WAS AUGUST LETTER WAS WRITTEN BY DR. JANINE CLAYTON WHO SPOKE AT THIS MEETING, IT FEATURED -- IT FOCUSED ON AND EMPHASIZED THE NEW NIH POLICY ON INCLUSION OF SEX ANALYSES IN PRE-CLINICAL RESEARCH. WE HE TALKED ABOUT HERE. JUST TO MAKE EVERYONE AWARE OF THE IMPORTANCE TO HAVE THE ISSUE OF SEX AND GENDER ISSUES IN DO ING RESEARCH NOT ONLY HUMAN RESEARCH BUT ANIMAL BEHAVIOR RESEARCH. I ENCOURAGE THE FREQUENTLY ASKED QUESTION THE OFFICE OF EXTRAMURAL RESEARCH GUIDE APPLICANTS, HER LETTER POINTS TO THAT AS WELL. ALSO CELEBRATION OF HISPANIC HERITAGE MONTH. NIH REFRESHED SPANISH LANGUAGE PORTAL, NEW SITE FEATURES QUICK EASY NAVIGATION TOOLS, TO HELP SPANISH SPEAKING INDIVIDUALS IDENTIFY AND LOCATE NIMS HEALTH TOPICS, IT ALSO INCLUDES LANDING PAGES THAT PROVIDE ALL INFORMATION ON A GIVEN TOPIC AND ADDITIONAL ENHANCEMENTS OR IMPROVED ACCESS TO NIMS SPANISH LANGUAGE HEALTH INFORMATION PARTICIPATING IN CLINICAL RESEARCH STUDIES AND RESPONSIVE DESIGN THAT MAKES THE SITE EASIER TO READ. THE WAY E KNOW IT IS GOOD BECAUSE MY WIFE REVIEWED IT AND SHE'S VERY GOOD IN SPANISH SO SHE GAVE HER STAMP OF APPROVAL AND SHE SETS A HIGH BAR SO IT MUST BE GOOD. WE'RE ALSO IMPROVING DIGITAL ACCESSIBILITY OF INFORMATION FOR AMERICAN INDIANS AND ALASKA NATIVES. ON BEHALF OF ACHE AMERICAN INDIAN ALASKA NATIVE HEALTH WORK GROUP, THE THEY LAUNCH AD E NEWS LETTER HONORING HEALTH RESOURCES FOR INDIANS AND AMERICAN NATIVES. WE HOPE THIS WILL BE UTILIZED, DE NOVO ISSUE FEATURES HEALTHY AGING WITH CONTENT FROM THE NATIONAL INSTITUTE OF AGING. I WANT TO TALK A LITTLE BIT ABOUT SOME OF THE ADVANCES THAT WE HAVE SEEN. BEAR WITH ME IN THAT A LOT OF THESE ADVANCES FOCUS MORE ON THE CLINICAL RATHER THAN BASIC. WE HAVE MANY, MANY ADVANCES. SOME OF THEM JUST TO PUT IN A CONTEXTUAL FRAMEWORK A MUCH EASIER TO DISCUSS IN -- IF THEY'RE CLINICAL RATHER THAN A MORE BASIC FIRST DEALS WITH ONE THAT COMES FROM GRACE PAPLAS LAB ENTITLED FRINGEIAL CELLS UNDERGO MYOGENESIS UNDER BASAL CONDITIONS AND SHE MIGHT WANT TO SAY SOMETHING ABOUT THIS, DEALING WITH STEM CELLS AND SWALLOWING MUSCLES THAT ARE DISTINCT FROM THOSE LIMB MUSCLES AND MAY ACCOUNT FOR WHY THERE ARE CERTAIN TYPES OF DYSTROPHIES THAT ONLY AFFECT THESE PHARYNGEAL MUSCLES. THEY UNDERCOVERED SOME WAYS TO TO PREPARE MAINTENANCE STEM CELLS, WITH TYPES OF MUSCLES WITH SKELETAL -- THEY ARE DIFFERENT THEY FUNCTION DIFFERENTLY AND INCORPORATE INTO THE MUSCLE CELLS DIFFERENTLY AND MAYBE AFFECTED DIFFERENTLY BECAUSE THEIR LIFE CYCLE BUT MORE IF THERE IS MORE TO SAY, GRACE, WE'LL INVITE YOU AT THE END. IT DOES PROVIDE INSIGHT INTO SWALLOWING PROBLEMS ASSOCIATED WITH AGING AND CERTAIN DYSTROPHY IES. ANOTHER VERY INTERESTING ADVANCE COMES FROM DR. (INDISCERNIBLE) AND COLLEAGUES AT TEMPLE UNIVERSITY PROVIDES BACTERIAL INFECTIONS DEVASTATING TO PEOPLE WITH LUPUS. THE FINDINGS OF DNA PROTEIN COMPLEXES CAN INDUCE LUPUS LIKE DISEASE, WE KNOW THAT IN ANIMAL MODELS, DR. (INDISCERNIBLE) AND COLLEAGUES DETERMINED THE INTERACTIONS BETWEEN BACTERIAL PROTEIN AND -- BETWEEN BACTERIAL PROTEIN CURRENTLY, THESE ARE SUBSTANCES THAT SURROUND THE BACTERIA AND FRAGMENTED BACTERIA DNA CONTRIBUTED MOLECULE KNOWN TO PLAY A ROLE IN LIEU PUS PATHOLOGY, SOMETIMES THEY ARE PROTECTED, SOMETIMES NOT PROTECTED. IN LIEU PUS THEY ARE NOT PROTECT AND ACCELERATE LUPUS THAT PATHOLOGY AND PROVOKE AUTO-IMMUNITY IN NORMAL CONTROL MICE. THIS IS A BIOFILM PEOPLE TALK ABOUT, BIOFILM, THESE STUDIES -- THESE STUDY DEMONSTRATE THESE STRUCTURES CAN PROTECT BACTERIA FROM THE IMMUNE SYSTEM OR CAN BE PART OF THE INFLUENCE ON THE IMMUNE SYSTEM THEY CAN TRIGGER CERTAIN TYPES OF IMMUNE RESPONSE S. THE NEXT IS A STUDY ON ME IN THISCAL INJURY PRECEDE CARTILAGE DAMAGE IN THE ARTHRITIC KNEE AND IT REALLY QUESTIONS THE CURRENT DOGMA OF BONE ON BONE BEING THE ACTUAL INSIDER OF THE OSTEOARTHRITIS. AND PAPERS IS CALLED WHAT COMES FIRST, MULTI-TISSUE INVOLVEMENT LEADERRING TO RADIO GRAPHIC OSTEOARTHRITIS, MAGNETIC RESONANCE IMAGING TRAJECTORY ANALYSIS OVER FOUR YEARS IN THE OSTEOARTHRITIS INITIATIVE. LAUNCHED NEW DATA CONNECTED TO THE OSTEOARTHRITIS INITIATIVE WE AND THE AGING INSTITUTE SUPPORTED FOR 12 YEARS, THIS IS DATABASE WE HAVE SUPPORTED THAT IS -- YOU GO TO ANY MEETING DEALING WITH RHEUMATIC DISEASE OR WITH MUSCULOSKELETAL DISEASE, PEOPLE USE THIS LONGITUDINAL DATABASE TO A GREAT EXTENT AND IT'S CHANGING HOW WE LOOK AT EVENT LEADING TO OSTEOARTHRITIS AND IDENTIFYING ASPECTS OF DISEASE THAT PROVE FRUITFUL DRUGGER TARGETS. OSTEOARTHRITIS SEVERITY IS QUANTITATED BY THE EXTENT TO WHICH ARTICULATE CARTILAGE IS MEASURED BY RADIO GRAPHIC JOINT SPACE, WITH DR. REAMER ACROSS THE UNIVERSITY AND COLLEAGUES COMPARED THE X-RAYS, THIS IS A MULTI-CENTER STUDY I BELIEVE. I KNOW IT IS. THEY COMPARED THE X-RAY AND MI FROM MORE THAN 350 PEOPLE IN THE OSTEOARTHRITIS INITIATIVE WHO DEVELOPED OSTEOARTHRITIS AND EQUAL NUMBER OF PARTICIPANTS WHO DID NOT DEVELOP OSTEOARTHRITIS AND IDENTIFIED SEVERAL MRI FEATURES THAT PRECEDED RADIO GRAPHIC OSTEOARTHRITIS BY ONE TO TWO YEARS. THE MAJOR RISK FACTOR THEY THINK WAS -- WERE EFFUSION INCENTVITIS AND OTHER SIGNS OF INFLAMMATION. BONE MARROW LESIONS AT VARIOUS LESIONS LEG BONES AND ME IN THISCAL DAMAGE, CART LANGUAGE DAMAGE LONG CONSIDERED THE PATHOGENERAL -- CARTILAGE DAMAGE THE HALLMARK OF OS YOUR ARTHRITIS WAS NOT ASSOCIATED WITH INCREASED RISK OF SUBSTANCETIVE RADIO GRAPHIC OSTEOARTHRITIS. SO HAVING FIVE OR SIX STRUCTURAL CHANGES CONSIDERED STATISTICALLY MEANINGFUL RISK FACTORS DRAMATICALLY INCREASES A PERSON'S RISK OF DEVELOPING OSTEOARTHRITIS NEXT YEAR OR TWO. EACH OF THESE INDIVIDUALLY OR IN COMBINATION COULD BE VIEWED AS RISK FACTORS BIOMARKERS MOVING THE FIELD BEYOND THE CARTILAGE TARGETS FOCUSED ON SO MANY CREASE. -- YEARS. THE NEXT TWO ALSO ADDRESSED OSTEOARTHRITIS, THE DISCONNECT BETWEEN PATIENT REPORTED SYMPTOM S AND JOINT DETERIORATION THAT SHOWED X-RAY OR MI. ONE IS OSTEOARTHRITIS AND ONE IS RHEUMATOID ARTHRITIS. DR. MESSIER FROM WAKE FOREST WE PUT ON THE DIET EXERCISE FOR ARTHRITIS TRIAL THE IDEA TRIAL 18 MONTH RADIO GRAPHIC MRI OUTCOMES. HE AND HIS COLLEAGUES SHOW IS THAT THIS DISCONNECT BETWEEN STRUCTURAL CHANGES AND CLINICAL SYMPTOMATIC CHANGES. IF ONE LOSES WEIGHT IT IT MAY IMPROVE SYMPTOMS OF OSTEOARTHRITIS. NO ONE IS HAS SHOWN BEFORE IT DOESN'T APPEAR TO SLOW JOINT DETERIORATION. VERY IMPORTANT STUDY. ONE ALWAYS LOOKS FOR CHANGE -- STRUCTURAL CHANGES BUT IT MAYBE THESE SYMPTOMATOLOGY RHEUMATOLOGISTS PROBABLY HAVE KNOWN THIS A LONG TIME. THIS IS GOOD PROOF THAT THEY DON'T GO TOGETHER AND IT MIGHT BE INTERESTING TO GO BACK AND LOOK AT THE FINDINGS OF OSTEOARTHRITIS STUDY I TALKED ABOUT, SEE IF THOSE PARAMETERS HAVE CHANGED WITH DIET OR THE PREVALENCE OF INFLAMMATION OR EFFUSION INCENTVITIS. RHEUMATOID ARTHRITIS, A STUDY BY RAIN GRAND AND OTHERS MULTICENTER STUDY DR. CURTIS, DR. MORELAND, DR. ODELL SUGGESTS ON GOING INFORMATION RHEUMATOID ARTHRITIS IN E REMISSIONS. THEY PUT PATIENTS IN REMISSIONS IN THE TIER TRIAL, TREATMENT OF EARLY AGGRESSIVE RHEUMATOID ARTHRITIS TRIAL, WHAT THEY FOUND WAS THAT PATIENTS WENT INTO REMISSIONS, BUT IF YOU DO MRI STUDIES YOU FIND THESE PATIENTS STILL HAVE ONGOING EVIDENCE OF DAMAGE. SO THE QUESTION IS WHAT IS THAT DAMAGE GOING TO DO? DO THEY HAVE DAMAGE ELSEWHERE, DO THEY HAVE INFLAMMATION ELSEWHERE? IS THAT STOPPING DRUG TREATMENT, IT DEALS WITH SIMILAR ISSUES OSTEOARTHRITIS TRIAL AS WELL. TALKING ABOUT BIOMARKERS. THERE WAS ANOTHER VERY INTERESTING STUDY, LARGE SCALE PROTEIN BIOMARKER DISCOVERY PROGRAM IN DUCHENNES MUSCULAR DYSTROPHY. I MIGHT GO TO THIS STUDY BUT TO TELL YOU OUR AWARDEES WE -- DR. MCDONALD FROM CALIFORNIA, HOFFMAN FROM WASHINGTON IN THE PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES AND FEEL DUCHENNES MUSCULAR DYSTROPHY THIS PROVOCATION DESCRIBES THE IDENTIFICATION OF 44 PROTEINS THAT COULD SERVE AS BIOMARKERS FOR DUCHENNE MUSCULAR DYSTROPHY BECAUSE THEY'RE PRESENT IN SIGNIFICANTLY DIFFERENT AMOUNTS BETWEEN DOES CHEN PATIENTS AN AGE MATCH CONTROLS. -- DUCHENNE PATIENTS AND AGE MATCHED CONTROLS SO A MATTER OF WHAT HAPPENS TO BIOMARKERS WHEN PATIENTS ARE TREATED. 18 PROTEINS WERE ELEVATED, YOUNG PATIENTS COMPARED TO AGE MATCH CONTROLS FELT THE NEW NORMAL LEVELS AS PATIENTS MATURED. ANOTHER 15 DIDN'T CHANGE CONCENTRATION WITH AGE AND PRESENT AT SIGNIFICANTLY LOWER AMOUNTS AND OTHER CHANGES IN THE OTHER PROTEINS. NOW WE KNOW FROM THIS STUDIES OF VAN DEBORN AND COWORKERS AT FLORIDA THAT MRI IS BECOMING A MIGHT BE INTERESTING FOR CATHY TO COMMENT, HOPEFULLY ACCEPTABLE AS A BIOMARKER AND THESE -- THE FDA HAS INCLUDED IN QUALIFICATIONS USING MRI BIOMARKERS, OTHERS ARE CONSTANTLY BEING SOUGHT AND WOULD BE INTERESTED TO KNOW WHETHER THIS GROUP PUT TOGETHER WITH THAT OTHER GROUP VALIDATES THE BIOMARKERS NOT ONLY THE SERUM BIOMARKERS IN THIS CASE SERUM PROTEINS WITH THE MRI BIOMARKERS, WHEN WE FINISH I WILL ASK YOU TO COMMENT ON THAT AS WELL. FINALLY I WANT TO TALK A BIT ABOUT A NEW DRUG TARGETING TGF BETA THAT IMPROVES SKIN DISEASE AND DECREASE BIOMARKERS IN PATIENTS WITH SCLERODERMA, A STUDY BY BOB (INDISCERNIBLE) AND OTHERS IN A GENERAL CLINICAL INVESTIGATION, THEY SHOWED THAT A ANTI-TGF BETA WAS NOT ONLY BIOMARKERS LOOKING AT SKIN BUT ALSO IMPROVING THE MODIFIED SKIN SCORE. OBVIOUSLY A STUDY THAT NEEDS TO BE -- THAT NEEDS TO BE REPLICATED ON A LARGER SCALE. ALL THESE NIMS FUNDED CLINICAL STUDIES ADDRESS PRESSING RESEARCH QUESTIONS THAT COULD DRAMATICALLY IMPROVE CARE, IMPROVE CARE IN LARGE POPULATIONS IN SOME CASES, IN SMALL POPULATIONS, IN OTHERS. THAT'S OUR GOAL FOR EVERY PROJECT OUR CLINICAL RESEARCH PORTFOLIO, HOWEVER THE PROCESS FOR MEETING THE GOAL VARIES WITH EVERY RESEARCH QUESTION. THEREFORE BEFORE GOING INTO THESE QUESTIONS I WANT TO FOR A MOMENT PEJORATIVE SENSE DIGRESS BUT ASK GRACE TO COMMENT ON THE DIFFERENTIAL THAT IS SHOWN IN STUDIES OF NASOPHARYNGEAL MUSCLES AND THE NEED FOR SATELLITE STEM CELLS AND CATHY IN TERMS OF IMPORTANCE OF IDENTIFY BIOMARKERS AND WE GET INTO THE LAST SLIDE WHICH IS STRENGTHENING THE IMPACT OF NIMS CLINICAL TRIALS. CATHY. >> GREAT. JUST TWO POINTS. ONE, I THINK OUR WORK TO TRY TELLING THE POINT THAT CELL BIOLOGY MUSCLE STEM CELL IS DIFFERENT IN DIFFERENT MUSCLE AND WE SHOULDN'T FOCUS ON STUDIES THAT LOOK AT MUSCLES AND THE SECOND POINT WAS JUST OUR FOLLOW-UP STUDIES USING ANIMAL MODELS OF DISEASE TO SEE THOUSAND HAO THOSE CELLS ARE AFFECTED. >> CATHY. >> THE MRI DUCHENNE IS EXTREMELY PROMISING. I THINK THE PROTEIN IN URINE BIOMARKERS ARE GOING TO TAKE MORE WORK TO UNDERSTAND EXACTLY WHAT THEY MEAN. CERTAINLY WE HOPE WE CAN FIND SOMETHING THAT RELATES TO DISEASE PROGRESSION. >> THANK YOU. I JUST GOT WORD FROM ALEX SOBER INDIRECTLY THAT VIDEOCAST IS BETTER THAN NET FLIX. >> I DON'T KNOW, MY EXPERIENCE WITH NET FLIX THAT DOESN'T SAY MUCH. >> THE HD QUALITY IS QUITE IMPRESSIVE ACTUALLY. >> VERY IMPRESSIVE. >> THANK YOU. >> GREAT. >> I CAN READ OTHER PEOPLE'S EMAILS SO MAYBE -- [LAUGHTER] >> WOW. I'M GLAD -- YOU CAN'T GO BACK IN TIME, GLAD WE STARTED THIS, AND I HOPE ACTUALLY LET ME MAKE A PLEA THAT I WOULD LIKE TO HEAR FROM PEOPLE WHO ARE LISTENING IN TO KNOW WHETHER THEY FIND THIS USEFUL. FOR PEOPLE ON COUNCIL IT'S IMPORTANT FOR US TO GET YOUR INPUT BUT PEOPLE NOT ON THE COUNCIL IT WOULD BE GREAT FOR ME AND US TO KNOW HOW USEFUL THIS TYPE OF INFORMATION EXCHANGE IS. AND ANY SUGGESTIONS YOU HAVE WE'RE CERTAINLY READY TO LISTEN TO THEM. I WANT TO GO BACK AND OPEN THE FLOOR, FEEDBACK ON ISSUES WE LOOK AT HOW BEST HOW TO IMPACT CLINICAL STUDIES TO IMPROVE LIVES OF PEOPLE AFFECTED BY DISEASES AND CONDITIONS WITHIN OUR MISSION. I WOULD LIKE TO START WITH CLIFF WHO I ASKED TO OPEN THIS, AND CLIFF IS A FORMER COUNCIL MEMBER BUT IMPORTANTLY THE CHAIR OF NIAMS STUDY THAT DEALS WITH CLINICAL TRIAL SUPPORT. CLIFF THE FLOOR IS YOURS AND THEN WE'LL OPEN UP. >> THANKS STEVE VERY MUCH. GREAT TO BE BACK SORT OF AND THE VIDEO IS AWESOME. SO LET ME JUST START BY SAYING I SPENT FIVE YEARS AS CHAIR OF AMCSD, THE CLINICAL TRIALS STUDY SECTION AND MANY OF YOU MAY KNOW THAT BACKGROUND BUT IT WAS FORMED IN RESPONSE TO THE NEED TO REALLY IMPROVE THE REVIEW OF CLINICAL TRIALS, BASICALLY DONE IN A REGULAR STUDY SECTION PREVIOUSLY AND THERE WAS A LOT OF COMPLAINTS THAT THE EXPERTISE WAS NOT THERE. SO THE PANEL WAS FORMED AND I CAN TELL YOU WE HAVE HAD SUCCESS AND LIMITATIONS. I WILL BRIEFLY MENTION THE SUCCESSES. IT TOOK US A YEAR AND A HALF OR TWO YEARS TO REALLY BRING TOGETHER IN A SYNCHRONOUS WAY CLINICAL TRIALSISTS INVESTIGATORS, BIOLOGISTS AND STATISTICIANS. I THOUGHT IT WOULD BE EASIER BUT IT WAS ACTUALLY QUITE DIFFICULT TO GET THEM ON THE SAME WAVELENGTH. THAT'S WHAT WE NEED TO HAVE A FAIR REVIEW OF A CLINICAL TRIAL. IT CAN'T JUST BE CLINICAL TRIAL, JUST CAN'T BE BIOSTATISTICIANS. AND EVERYBODY COMES FROM A DIFFERENT PERSPECTIVE. SO HARMONIZING THOSE INTERESTS INCLUDING BASIC BIOLOGY REQUIRES A FAIR AMOUNT OF EFFORT. AND I THINK THAT RUN IN PERIOD WAS AT LEAST A YEAR BEFORE EVERYBODY WAS IN SYNC SAYING THE COMMON PURPOSE OF THE FUND IS TO LOOK AT THE BEST CLINICAL TRIALS AND RECOMMEND THOSE TRIALS BASED ON SCORES. I THINK WE HAVE DONE A REALLY GOOD JOB WITH THAT. THAT'S BEEN ONE OF THE SUCCESSES AND I WOULD ENCOURAGE PEOPLE TO SIT IN ON THESE MEETINGS BECAUSE THEY'RE AMAZINGLY INTERESTING BECAUSE YOU HAVE SO MANY DIFFERENT PERSPECTIVES. AND LEADERSHIP IN THAT IS VERY IMPORTANT AND I HAVE LEARNED A TREMENDOUS AMOUNT IN THE FIVE YEARS I HAVE BEEN DOING THIS. BECAUSE IT DOES REQUIRE CONSENSUS. IT'S ALSO A MODEL DK AND NIA HAVE BEEN VERY INTERESTED IN HOW WE DO THIS BECAUSE THEY'RE CONSTITUENCY HAS THE SAME COMPLAINT THAT CLINICAL TRIALS ARE NOT REVIEWED BARELY. I THINK THE INSTITUTION, THE THE INSTITUTE ADDING THE COS, THE OBSERVATIONAL STUDY IS A REAL PLUS, IT WAS APPROXIMATE AREA THAT WE DIDN'T KNOW REALLY HOW TO DEAL WITH IT IN THE CLINICAL TRIALS REVIEW PANEL AND I THINK ADDING THIS IS GOING TO OPEN UP OPPORTUNITIES FOR OTHER INVESTIGATORS. THE OTHER SUCCESS IS THE PLANNING GRANTS. THESE ARE ESSENTIAL, THEY'RE COST EFFECTIVE, I THINK THEY'RE MUCH BETTER THAN TRYING TO INCORPORATE PLANNING INTO A CLINICAL TRIAL AND I THINK FOR THE MOST PART WHAT I SEE IS THOSE PLANNING GRANTS WORK BECAUSE IN A WAY THEY ALSO GET AIRED AT CONCEPT EPICLEARING. U-34 PLANNING GRANTS BUT EVERYBODY IS DISCUSSING AROUND THE TABLE HOW THOSE TRIALS ARE ULTIMATELY GOING TO BE IMPLEMENTED. SO THERE IS SOME CONCEPT CLEARING IN THAT. LIKE ANY STUDY SECTION THERE ARE LIMITATIONS AND THERE ARE CONCERNS AND THERE ARE FEEDBACK FROM OTHER INVESTIGATORS THAT HAVEN'T BEEN AS SUCCESSFUL AND I ACTUALLY SEE -- EMAILED ME AND I CALLED A FEW PEOPLE AND LISTENED TO SOME OF THE CONCERNS AND COMPLAINTS. AND IT'S NOT SURPRISING LIKE ANY STUDY SECTION THOSE THAT DON'T DO WELL, TEND TO COMPLAIN, BUT THERE'S SOME RATIONALE FOR SOME OF THESE. I WANT TO HIGHLIGHT A COUPLE OF THINGS THAT I THINK WE COULD FOCUS ON BECAUSE THEY MAY BE MODIFIABLE. ONE THING IS PEOPLE ARE GOING BACK AGAIN AND AGAIN IN MULTIPLE ATTEMPTS TO GET FUNDED AND I JUST HEARD ON THE PHONE EARLY THIS MORNING FROM A VERY SENIOR INVESTIGATOR WHO IS IN FOR THE THIRD TIME IN AN R-21 EXPLORATORY CLINICAL GRANT. HER COMPLAINT WAS REALLY RELATED TO THE IDEA THERE WASN'T ENOUGH EXPERTISE AFTER THOSE IN CONFLICT LEFT THE ROOM. THIS HAPPENED TO BE A BONE GRANT SOY UNDERSTAND WHAT THAT WAS ABOUT AND WE CAN IMPRO-THAT BY ACTUALLY MAKING SURE WE HAVE MORE PEOPLE ON AD HOC. THAT HIGHLIGHTS ANOTHER IMPORTANT POINT N THE FIVE YEARS I HAVE BEEN THERE, MOST OF THE SAME PLAYERS HAVE BEEN THEREN WE NEED TO ROTATE MORE STUDY SECTION PEOPLE AND CONSIDER THE IDEA THAT MAYBE A THREE YEAR TERM OR A TWO YEAR TERM WOULD WORK. THE REASON I SAY THAT, THOUGH THE MIX OF PEOPLE REALLY WORKS WELL, WE NEED GREATER VISIBILITY IN THE RESEARCH COMMUNITY TO UNDERSTAND HOW WELL THE SYSTEM WE THINK WORKS AND THEREFORE GETTING MORE PEOPLE IN, PEOPLE CAN SEE WHAT WE'RE DOING, IT'S MUCH MORE TRANSPARENT. SO I HOPE TO ROTATE PEOPLE MORE RAPIDLY THAN WE HAVE BEEN DOING IT. AND I THINK THAT GOES ALONG WITH THE ISSUE OF IF THERE'S CONFLICT, IN IS WHAT THEY DO. I THINK WE CAN ALSO TO A BETTER JOB OF FOCUSING ON THE YOUNG INVESTIGATORS AND MAKING SURE THAT THERE'S SOME CONSENSUS AROUND THOSE INDIVIDUALS, TRYING TO MAKE SURE THAT THE FEEDBACK WE GIVE THEM IS APPROPRIATE AND THEY UNDERSTAND THE PROCESS AND WHERE THEY NEED TO MAKE REVISIONS. THE OTHER THING THAT I THINK IS REALLY CRITICAL IS WE NEED METRICS. WE NEED GOOD METRICS TO UNDERSTAND HOW WE'RE DOING. THAT'S AN AREA THAT I REALLY THINK WE'RE GOING TO HAVE TO FOCUS ON IN SOME WAY, WHAT ARE THINGS THAT ARE GETTING THROUGH. AND WHY THEY'RE GETTING THROUGH WHY ARE SOME HELD UP OR NOT RECOMMENDED TO GO FURTHER. THAT'S AN IMPORTANT ISSUE SO LOOKING AT THOSE THAT DON'T MAKE IT OR NOT AS CLOSE ARE IMPORTANT AND DECIDING ON METRICS THAT CAN HELP US IMPROVE OR OWN PERFORMANCE IS GOING TO BE ESSENTIAL. STEVE AND I TALKED ABOUT THIS NOT EVERY STUDY IS A HOME RUN, NOT EVERY ONE MAKE IT IS NEW ENGLAND JOURNAL AND VERY FEW ARE, EDITING THE NEW ENGLAND JOURNAL A YEAR AND A HALF, I UNDERSTAND THAT PROCESS, THE ONES THAT MAKE IT ARE HUGE AND THE ONES THAT WE'RE LOOKING AT ARE MUCH MORE INCREMENTAL. THEY LOOK AT RELATIVE CHANGES OF 50% RISK REDUCTION OR RISK. SO THEY'RE NOT THE INSTITUTE IS NOT SPONSORING THESE HUGE TRIALS BUT THESE ARE VERY IMPORTANT STUDIES. AND THEY NEED TO BE DONE IN NIAMS IS THE INSTITUTE TO DO IT. SO WE HAVE TO SORT OF KEEP THAT IN MIND AS REVIEWERS AND AS FUNDERS, THAT THIS IS IMPORTANT SCIENCE. IT NEEDS TO BE -- IT NEEDS TO BE CONTINUED. MY LAST COMMENT HAS TO DO WITH CONCEPT CLEARING AND THE ISSUE OF IS THERE A BETTER WAY TO DO CONCEPT CLEARING AND FOR THAT I'M GOING TO FALL BACK TO MY FOUR YEAR TERM AT THE NATIONAL INSTITUTE OF AGING WHERE WE WERE INVOLVED IN CONCEPT CLEAR, CALLED THE CLINICAL TRIALS PLANNING REVIEW GROUP. WHAT WE DID, AND THE MISTAKE THERE I THINK WAS NIH SET PRIORITY, THEY GAVE IT TO CCAP OUR GROUP AND THEY OPENED IT UP TO THE INVESTIGATORS. THE INVESTIGATORS FED IN CONCEPTS, WE REVIEWED IT, IT WENT BACK TO NIA. THE PROBLEM IS, IS THAT THE CONCEPT STARTED AT NIA, NOT WITH THE INVESTIGATORS. OFTENTIMES WE GET THESE CONCEPTS BUT THE INSTITUTE WOULDN'T ENDORSE IT. SO THE FRUSTRATION AT THE INVESTIGATOR LEVEL WAS HERE ARE MORE LOOPS TO GO THROUGH BEFORE YOU EVEN GET INTO A PEER ARE VIEW SYSTEM. AND SO I THINK THAT WOULD NOT WORK FOR OUTS IN THE CONCEPT CLEARING STATUS. I THINK WE HAVE TO THINK ABOUT OTHER WAYS OF DOING THAT, THAT ARE BASED ON THE INVESTIGATOR PROPOSING THE CONCEPTS AND THEN SOME FORM OF CLEARINGHOUSE. SO THOSE ARE INs SENSE MY SUMMARY OF FIVE YEARS, SUCCESSES AND LIMITATIONS. WE NEED TO BE AS TRANSPARENT AS WE POSSIBLY CAN. I KNOW THERE'S FRUSTRATION OUT THERE. A LOT HAS TO DO WITH THE FUNDING LEVELS. I'M SURE THIS IS TRUE FOR OTHER STUDY SECTIONS, BUT I THINK WE HAVE TO SELL THE FACT THAT WE ARE MAKING AN EFFORT IN THAT THING VERSUS WORKED AND BOTH THE STUDY SECTION HAS EVOLVED AND OUR CONCEPTS OF WHAT WORKS. AND IF WE CAN GET MORE METRICS AND SOME FEEDBACK, I THINK THAT WOULD BE VERY HELPFUL SO I'M OPEN TO COMMENTS AND DISCUSSION. I HOPE I ELUCIDATE DAYTIMED THE MAJOR POINT. >> THANK YOU VERY MUCH. I WOULD SAY WE HAVE ACTUALLY STARTED ROTATING THE FEEDBACK THEY HAVE GOT IS A GREAT JOB AND WE APPRECIATE GREATLY, HE HAS STARTED ROTATING THE REVIEWERS. THE CONCEPT CLEARANCE HAS ALWAYS BEEN IN THE INSTITUTE FOR THE COMMUNITY TO SEND IN CONCEPTS AND FOR SUBGROUP OF COUNCIL TO LOOK AT THOSE, NOT VERY HELPFUL BECAUSE EVERYTHING THAT COMES IN COULD CHANGE CLINICAL PRACTICE. THE THIRD THING, THIRD THING THERE IS RFI REQUEST FOR INFORMATION ON THE STREET WE APPRECIATE PEOPLE RESPONDING TO ORGANIZATIONS RESPONDING TO AND FOUR, THESE CLINICAL TRIALS ARE EXPENSIVE. WE LOOK AT THEM CAREFULLY TO SEE WOULD IT MAKE A DIFFERENCE NOT JUST WHETHER IT'S DONE BUT WILL IT MAKE A DIFFERENCE. AS YOU SAY, IF YOU HAVE AN INCREMENT OF DIFFERENCE, IN A POPULATION OF PEOPLE THAT WHERE THE DISEASE AFFECTS 10 MILLION PEOPLE AN INCREMENT IS IMPORTANT. BUT WE HAVE TO THINKN'T OUR BUDGET IN TERMS OF WHAT IT DOES TO THE REST OF OUR BUDGET. SO THAT'S WHERE THE BALANCE SHEET IS. DOES ELIZABETHER ALEX HAVE A COMMENT? >> ELIZABETH. I -- THANKS P CLIFF, THAT WAS A GREAT SUMMARY. AWARE OF THE STEPS YOU HAVE TAKEN SO I'M GLAD TO KNOW AND IT WOULD BE GREAT IF THERE WERE A WAY TO CONVEY ALL THAT WORK AND PROGRESS THAT YOU HAVE DONE TO THE REST OF THE COMMUNITY. I DON'T KNOW WHETHER THAT'S POSSIBLE. >> I WAS GOING TO SAY, VERY SIMILAR THING WHICH IS THERE A WAY, IT'S FANTASTIC INFORMATION. IS THERE A WAY IN A SIMPLE FORM WHETHER ONLINE TO MAKE THESE FINDINGS REALLY KNOWLEDGE ASSESS -- ACCESSIBLE TO THE COMMUNITY, THE RARE DISEASE COMMUNITY OR COMMUNITY AT LARGE BECAUSE EACH OF THESE THINGS BUILDING UPON THE KNOWLEDGE OF OTHERS AND EFFECTIVELY UNDERSTANDING WHAT WORKS, WHAT DOESN'T, SHORTCOMING MISTAKES PRESERVES THE GREATEST ASSET OF TIME TO EACH OF THESE DISPARATE COMMUNITIES IN GENERAL THE COMMUNITY AT LARGE. SO THERE IS A WAY TO PUT THIS TOGETHER IN A FORMAT THAT ISN'T TOO COUPLE BEARSOME ON YOU OR THE PARTICIPANTS BUT ALSO DISTILLS TO THE KEY POINTS WOULD BE A GREAT VALUE PERSONALLY. >> SO WE FOCUS MONTHLY NEWS LETTERS ON THE WAYS WE APPROACH THIS, BOB CARTER AND CERTAINLY JOE MCGOWAN AND SUSANNAH SERRATE-SZTEIN CRITICAL IN IMPLEMENTING THESE CHANGES, TALKED ABOUT THEM AT VARIOUS AND SUNDRY MEETINGS BUT IT'S CLEAR IT IS NEVER ENOUGH AND REDUNDANCIES IN THIS PARTICULAR CASE ARE IMPORTANT AND MESSAGE HAS BEEN HEARD. CINDY. >> I WANT TO CONGRATULATE CLIFF AND STUDY SECTION THIS IS REALLY IMPORTANT ADVANCE IN TERMS OF CLINICAL TRIALS. I WANT TO RAISE GRADATIONS IN CLINICAL TRIALS. THE NIH DEFINITION OF CLINICAL TRIAL IS FAIRLY UNEQUIVOCAL, THERE'S BEHAVIORAL OR PHARMACEUTICAL INTERVENTION INVOLVED. LET ME PROPOSE A SCENARIO THAT I DON'T THINK IS THAT UNCOMMON AND ASK WHERE THAT TYPE OF GRANT WOULD BEST GO. ESPECIALLY IN THIS ERA OF MULTIPLE PIs, YOU CAN ENVISION A RO-1 APPLICATION THAT ISN'T 2 MILLION, IT'S UNDER 500,000, MODEST SIZE, THAT MAY INVOLVE ONE OR TWO BASIC OR NULL STUDIES LOOKING AT SOME MECHANISM, AIM THREE INVOLVES A HUMAN STUDY THAT HAS SOME INTERVENTION IN IT. IT'S NOT THERAPEUTIC INTENT BUT AN INTERVENTION OF SOME SORT THAT ARE ENLIGHTENED THE UNDERLYING MECHANISMS. BY KIND OF A SIMPLE DEFINITION THAT BECOMES A CLINICAL TRIAL GRANT BUT IT'S VERY DIFFERENT FROM PHASE 2 OR 3, $3 MILLION STUDY THAT THE STUDY SECTION USED TO REVIEWING. I GUESS THE QUESTION IS FOR THOSE TYPES OF STUDIES, WHICH WE WANT TO ENCOURAGE, IT BUILDS TEAM SCIENCE, HELPS TRANSLATE FROM BASIC TO CLINICAL HUMAN STUDIES, DO YOU THEN WANT THOSE INVESTIGATORS TO GO THROUGH A PRE-APPROVAL PROCESS THROUGH CONCEPT TO PLANNINGING GRANT, OR OTHER BETTER MECHANISMS TO PUT THOSE GRANTS FORWARD AND SHOULD THEY GO TO CLINICAL TRIALS STUDY SECTION ASSUMING THEY CAN GARNER THE APPROPRIATE EXPERTISE PERHAPS THROUGH AD HOC MEMBERS, YOU CAN ARGUE THAT MIGHT HAVE BEEN THAT MIGHT BE A STUDY SECTION THAN PURELY BASIC STUDY SECTION THAT ISN'T USED TO DEALING WITH STUDIES. MY CONCERN IS SOME OF THESE DO FALL THROUGH THE CRACKS AND THOSE ARE KINDS OF STUDIES WE WANT TO ENCOURAGE. ELIZABETH AND I TALKED ABOUT THIS, MAYBE ELIZABETH WANTS TO COMMENT ON -- >> THANK YOU. I WOULD LIKE TO COMMENT ON IT, BECAUSE I HAVE HAD MYSELF CONCERNS ABOUT THIS PARTICULARLY FROM THE PERSPECTIVE OF CLINICAL INVESTIGATOR AND PARTICULARLY FROM THE PERSPECTIVE OF WANTING TO DO MECHANISTIC SCIENCE. IT'S FAIRLY HARD TO DO MECHANISTIC CLINICAL STUDIES IF THERE IS NO WAY TO PERTURB THE SYSTEM. EVEN IF NOT WITH THERAPEUTIC INTENT, IF IT'S A PRESERVATION OF SYSTEMS THAT JUST LOOKS AT HOW SOMETHING WORKS OR TEST IT IS HYPOTHESIS ABOUT A MECHANISM. SO I THINK THAT WE NEED TO HAVE SOME SORT OF MECHANISM, TYPE OF MECHANISM WHEREBY A GRANT WHICH IS PRIMARILY NOT A LARGE CLINICAL TRIAL BUT WHICH DOES HAVE A NAME THAT SPEAKS TO PERTURB THE SYSTEM IN ORDER TO ASK A QUESTION THAT IS MECHANISTIC ABOUT AN ISSUE NEEDS TO HAVE A HOME TO GO FOR REVIEW. I VERY MUCH AGREEMENT GRIEVE WITH SUNDEEP, I DON'T KNOW WHAT THE RIGHT ANSWER IS OR WHERE IT'S BEST REVIEWED BUT I THINK WE DO NEED TO THINK ABOUT THAT SORT OF INTERVENTION IN A DIFFERENT WAY FROM A CLINICAL TRIAL PER SE. >> SO THANK YOU FOR THAT COMMENT. THIS IS A DIFFICULT ISSUE, THE DEFINITION OF CLINICAL TRIALS HAS BEEN EXPANDED BY THE NIH. AND PROTOCOLS THAT INVOLVE AN INTERVENTION IN HUMANS IN ORDER TO MANIPULATE THE SYSTEM IF YOU WILL STUDY MECHANISM IS NOW INCLUDED AS PART OF THE DEFINITION OF A CLINICAL TRIAL. THE PROBLEM FOR US, IF WE ACCEPT THOSE, AND WE APPLY THE DEFINITION OF CLINICAL TRIAL, WHAT ARE THE REGULAR RATORY REQUIREMENTS IMPOSED IN THOSE DIVERSE STUDIES. HUMAN SUBJECTS CONCERNS, SAFETY ISSUES, REGULATORY ISSUES, FDA INVOLVEMENT, ARE SOMEWHAT DIFFERENT FOR MECHANISTIC TRIALS VERSUS THOSE TRADITIONAL INTERVENTIONAL STUDIES LOOKING FOR CLINICAL OUTCOMES THAT MIGHT BE UNKNOWN AT THE TIME THE INTERVENTION BEGINS. SO THERE ARE LEVELS OF COMPLEXITY ACCEPTING APPLICATIONS, REVIEWING APPLICATIONS DIFFICULT CLINICAL TRIALS DESIGNED TO TEST NEW INTERVENTION VERSUS MECHANISTIC STUDIES, THE TYPE OF EXPERTISE YOU NEED BE SOMEWHAT DIFFERENT AND REQUIREMENTS APPLICANT AND APPLICATION WOULD BE SOMEWHAT -- SHOULD BE SOMEWHAT DIFFERENT. THE PROBLEM IS YOU PUT THEM TOGETHER THEN YOU PUT EVERYONE UNDER THE SAME REQUIREMENT. >> ELIZABETH ANDRY ARGUING THEY ARE NOT TO BE PUT TOGETHER, THEY ARE FUNDAMENTALLY DIFFERENT. THE REGULATORY ISSUES ARE LESS A CONCERN BECAUSE WHEN YOU STUDY HUMANS YOU HAVE THE SAME IRB REQUIREMENTS, THE IND IDE INTERVENTION SO FORTH, IS MORE HOW NIAMS DEALS WITH APPLICATIONS AND HOW OR WHERE THEY REVIEWED BECOMES THE ISSUE. >> IT GETS TO THE DEFINITION WHICH IS NOT JUST INTERVENTION BUT IT HAS AN EFFECT ON HEALTH RELATED OUTCOME. AND I AGREE WITH YOU, THAT IS A BROAD DEFINITION THAT ADMINISTRATIVELY THINGS ARE NOW CLINICAL TRIALS. BUT THE ISSUE IS HOW DO YOU INTERPRET THAT HEALTH RELATED OUTCOME. IN THAT CASE, IF SOMETHING HAS EFFECT ON B CELL, B CELLS ARE RELATED TO HEALTH BUT NIAMS COULD DRY DRAW A LINE TO SAY THIS ISN'T REALLY ABOUT HEALTH, THIS IS ABOUT B CELLS. SO I AGREE ADMINISTRATIVE ISSUES CAN BE DEALT WITH, THERE ARE CLINICAL TRIALS THAT GO THROUGH REGULAR CSR THAT WE CAN TRY TO FIND A WAY TO DRAW THAT LINE BETWEEN SOMETHING PRIMARY HEALTH OUTCOME VERSUS MECHANISTIC ONE THAT AFFECTS SOMETHING THAT IS SOMEHOW RELATED TO HEALTH. I WOULD LIKE TO WEIGH IN ON BOB'S COMMENTS. I A AGREE WITH THAT, THE WAY STEVE AND THE REST OF THE INSTITUTE CONCEPTUALIZED THE STUDY SECTION WAS THAT THERE WOULD BE BIOLOGISTS AND THERE WOULD BE MECHANISM THAT WOULD BE -- THAT WOULD HAVE TO BE ADDRESSED. WE CERTAINLY SEE STUDIES IN WHICH THERE ARE MECHANISMS INVOKED OR PROPOSED, BASED ON SURROGATE MEASURES AND AS YOU CAN IMAGINE THEY RANGE FROM A LOT OF DIFFERENT PERSPECTIVES. BUT I THINK SUNDEEP'S POINT WELL TAKEN THERE ARE RO-1s THAT HAVE A BASIC OR TRANSLATIONAL COMPONENT WITH THE STUDIES AND THEN SOME CLINICAL OUTCOMES. AND I THINK ANSET CAN DEAL WITH THAT. WE CONSTITUTED IT SO THAT IT IS MECHANISTICALLY ORIENTED. THAT'S A QUESTION THAT COMES UP FREQUENTLY ESPECIALLY IN THE PLANNING GRANT WHEN WE'RE THINKING ABOUT THE TRANSLATIONAL ASPECTS OF HOW THAT GRANT WILL LOOK. HOW THAT TRIAL WILL LOOK ONCE IT COMES OUT. SO I THINK THAT THAT IS AN IMPORTANT POINT. ONE OTHER POINT, I THINK PEOPLE MENTIONED THE VISIBILITY ISSUE. AND I THINK WE COULD GO FURTHER BY PROMOTING IT AT DIFFERENT MEETINGS. THE UNIQUE THING ABOUT AMSET, IT'S SKIN, MUSCLE BONE ARTHRITIS ALL IN ONE GROUP. SO WE TEND TO -- IT'S JUST A FUNCTION OF MAKING SURE THAT THE BONE PEOPLE KNOW THIS IS WHERE IT'S GOING AND THIS IS THE GROUP OF PEOPLE, AND THE SKIN PEOPLE AND ARTHRITIS PEOPLE, I THINK IT COULD BE ADVERTISED MORE EASILY, AT SOME OF THE SPECIALTY MEETINGS. >> COULD I JUST SWEAR APOLOGETIC, THIS IS ELIZABETH AGAIN. I THINK THAT -- INTERJECT. THIS IS ELIZABETH AGAIN. I THINK THAT'S GREAT, IN FACT I WAS THINKING MAYBE VARIOUS NUMBERS OF THE STUDY SECTION WITH EXPERTISE IN THE DIFFERENT MISSIONS COULD WRITE A SMALL PERSPECTIVE FOR THEIR MAIN JOURNAL LIKE JBMR OR THE OTHER MAJOR JOURNALS AND JUST SORT OF HAVE AN INVITED OR PERSPECTIVE OR SHORT THING TALKING ABOUT THE TRIAL -- THE STUDY SECTION FOR THEIR CONSTITUENCY, THAT'S ANOTHER WAY AS WELL AS THE MEETING. I DECIDED TO GET BACK TO THE ISSUE OF THESE SMALL PER THE TEAR BASES OF THE SYSTEM THAT MEANT TO ASK MECHANISTIC QUESTIONS. I DON'T ALWAYS NECESSARILY SEE IT IN THE CONTEXT OF A BASIC OR TRANSLATIONAL STUDY. OFTENTIMES THERE ARE OBSERVATIONAL STUDIES THAT ARE CROSS SECTIONAL, PERSPECTIVE LONGITUDINAL STUDIES WHERE IT MIGHT MAKE SENSE TO TAKE A SMALL GROUP OF INDIVIDUALS WHO HAVE DISEASE QUESTION AND INTERVENE IN SOME WAY THAT LOOKS AT ONE OF THE MECHANISMS ONE IS TESTING. I JUST DON'T -- I DON'T KNOW HOW THAT WOULD WORK WITHIN YOUR STUDY SECTION. BUT TO HAVE TO DO A PLANNING GRANT FOR THAT WOULD ADD QUITE LOT OF TIME TO PREPARATION OF THE RO-1. AND TO SUBMIT THE STUDY WITHOUT THAT WOULD MEAN IT'S PURELY OBSERVATIONAL WITHOUT VERY MUCH MECHANISM INVOLVED. I THINK IT'S HARD TO DO A CLINICAL RESEARCH STUDY THAT IS MECHANISTIC WITHOUT PERTURBING THE SYSTEM IN SOME WAY. SO I'M HOPEFUL THAT WHAT BOB SAID WILL TURN OUT POSSIBLE, THERE WILL BE A WAY TAKING THESE THINGS NOT NECESSARILY AFFECTING A HEALTH OUTCOME PER SE. BUT SMALL INTERVENTION MEANT TO LOOK AT PATHOPHYSIOLOGY AND VIEWING IT IN A SOMEWHAT DIFFERENT CONTEXT, MAYBE IT SHOULD GO TO THE CTs, THE NIAMS CTs BUT I DON'T THINK IT -- THEY ALWAYS NEED A PLANNING GRANT, IT MAYBE A SMALL NUMBER OF PEOPLE. ALL OF OUR INSTITUTIONS ARE SUBJECT TO INTENSIVE OVERSIGHT WITH IRB AND FDA AND REQUIREMENTS. SO IT'S NOT LIKE PLANNING A $3 MILLION STUDY, THESE ARE SMALL STUDIES PROF OF CONCEPT STUDIES SOMETIMES EVEN USING THE RO-1 MEEK ANYMORE TO IN ADDITION TO DOING OBSERVATIONAL STUDIES BUT ALSO TO LOOKING AT TO DETERMINE WHETHER YOU CAN GET PRELIMINARY DATA TO THINK -- TO DETERMINE WHETHER SOMETHING SHOULD GO FORWARD, LATER ON IN THE CLINICAL TRIAL. THESE ARE DIFFERENT QUESTIONS AND AND WE HAVE TO -- THEY'RE IMPORTANT QUESTIONS, AND I THINK WE NEED TO FIND A WAY TO DEAL WITH THEM. >> I CAN'T HEAR. (OFF MIC) >> I'M SORRY, I'M NOT ABLE TO -- >> WE'RE HAVING TROUBLE HEARING. >> CAN'T HEAR. >> IS IT WORKING NOW? >> YES. >> GOOD. SO MY COMMENT WAS JUST TO FOLLOW-UP WITH SUNDEEP, IFFY THAT FIRST OF ALL THIS IS A -- I THINK THIS IS A GREAT ATTRIBUTE TO NIAMS HAVE THOUGHT THIS THROUGH AND CREATED THE STUDY SECTION. BUT I THINK THAT THE GRANTS YOU DESCRIBE SUNDEEP ARE GOING TO COME MORE FREQUENTLY. BECAUSE CERTAINLY WE'RE STRONGLY ENCOURAGING OUR INVESTIGATORS WHO ARE DOING BASIC MECHANISTIC STUDIES TO ASK THE QUESTION LIKE SO WHAT. SO WHAT IS THAT AIM 3 NOW WHERE YOU'RE ASKING THE QUESTION WHETHER OR NOT THIS ACTUALLY AFFECTS HUMANS. I WOULD SUGGEST, THINKING ABOUT THIS NOW, I THINK ABOUT THESE AS HYBRID GRANTS IN MANY WAYS WHERE YOU WANT AIM 3 TO BE REVIEWED EXPERTLY, NOT ENOUGH TO SAY WE MADE THIS DISCOVERY AND NOW TAKE IT TO CUBANS WHICH IS WHAT MANY PEOPLE DO IN THAT AIM 3. BUT DO IT IN A WAY RIGOROUS AND THOUGHTFUL SO HAVING A WAY TO UNDERSTAND THESE GRANTS, MAKE SURE STUDY SECTIONS BELONG IN A STUDY SECTION THAT WE PERHAPS USE THE EXPERTISE OF THE CLINICAL INVESTIGATORS TO AD HOC FOR PARTICULAR GRANTS WHERE THIS QUESTION COMES UP YOU WILL SEE MORE OF THESE. THAT'S THE APPROPRIATE EVOLUTION >> THANK YOU. I WANT TO MAKE A COMMENT ABOUT SOMETHING A LITTLE BIT DIFFERENT IF THAT IS OKAY. FIRST TO CONGRATULATE NIAMS AND THE TEAM, THIS IS A REMARKABLE ADVANCE AND I'M NOT SURPRISED THAT OTHER AREAS OF NIH ARE LOOKING AND LEARNING FROM WHAT YOU DO AND HOPEFULLY TRYING TO FOLLOW SUIT. I WANT TO TALK ABOUT THE OBSERVATION, THE CLINICAL OBSERVATION. I THINK THAT IS ALSO OOH GREAT STEP FORWARD BECAUSE CLINICAL OBSERVATIONAL STUDIES DONE RIGHT SHOULD HELP IDENTIFY RESEARCH QUESTIONS WHICH MIGHT BE MOST PROMISING. AND FEEL THAT UNMET NEED. MY QUESTION IS WHAT ABOUT THE OTHER OBSERVATIONAL STUDIES CAN ALSO INFORM THE PROCESS OF THE OTHER END IF YOU WILL, POST INTERVENTION AFTER THE TRIAL IS DONE OR POST MARKETING. THAT INTERSECTS WITH THE WORK AT THE FDA OR OMAP OR THE UDALL FOUNDATION SO MORE PHARMACO AT THE HOST INTERVENTION SIDE. I WONDER IF ANY THOUGHT IS GIVEN TO OBSERVATIONAL STUDIES AT THAT END OF THE PROSECT WHICH CAN FEED WACK AND -- BACK AND INFORM THE NEXT CLINICAL TRIAL. IS THAT IN SCOPE, OUT OF SCOPE, WHAT DO FOLKS THINK ABOUT THAT? >> TO ME IT WOULD BE IN SCOPE IF RELATED TO ONE OF OUR VISIONARIES OBSERVATIONAL TRIAL AS YOU SAW IN TRIANGLES SHOWN IN THE FIRST SLIDE, LEADS TO SUCH A INTERVENTIONAL TRIAL. OBSERVATIONS WHETHER IDENTIFICATION OF RISK FACTORS, IDENTIFICATION OF BIOMARKERS, ET CETERA, MIGHT LEAD TO A CLINICAL TRIAL. >> MAYBE IT'S A BIT OF REFRAMING. THE WAY THE SLIDE SUGGESTED IT WAS THAT IT WAS BEFORE THE TRIAL. I SEE IT INFORMATIVE. >> I ABSOLUTELY AGREE WITH THAT. ONE LAST COMMENT THEN MOVE ON. >> I THINK THIS HAS BEEN REALLY HELPFUL DISCUSSION. THE WAY I SEE IT CLINICAL TRIAL STUDY SECTION IS IDEALLY SUITED TO THE INTERVENTIONAL CLINICAL TRIAL, PLANNING GRANT IS REQUIRED. YOU WANT TO FUND THE RIGHT THING. TO ME THE DISCUSSION, THERE'S TWO FLAVORS, WHAT ELIZABETH IS TALKING ABOUT IN TERMS OF PURELY HUMAN STUDIES WHICH DON'T NESTLY INVOLVE BASIC OR MOUSE STUDIES, THESE ARE HUMAN STUDIES WITH SMALL NUMBERS OF SUBJECTS THAT INVOLVE SOME INTERVENTION TO GET AT UNDERLYING MECHANISMS IN HUMANS. POTENTIALLY THAT COULD GO TO THIS CLINICAL TRIAL STUDY SECTION BUT TO HAVE A PLANNING GRANT FOR THOSE STUDIES WHICH GENERALLY UNDER $500,000, REQUIRE SMALL NUMBERS OF SUBJECTS DOESN'T SEEM LIKE IT'S THE RIGHT APPROACH. THEN THERE'S THE THIRD FLAVOR WHICH IS THE TRULY TRANSLATIONAL STUDIES THAT INVOLVE BASIC AND HUMAN STUDIES. THOSE MAYOR MAY NOT BELONG IN THE CLINICAL TRIAL STUDY SECTION BUT IT'S NOT CLEAR STUDY SECTIONS HAVE NECESSARY EXPERTISE EITHER AND THOSE HAVE TROUBLE BECAUSE NOBODY KNOW HOUSE TO REVIEW THEM. >> WE HAD -- GO BACK TO ONE OTHER COMMENT ON CONFLICT, IT'S A REAL ISSUE BECAUSE ONE CYCLE WE HAD THREE OR FOUR LARGE CLINICAL TRIALS WHICH ARE MULTI-SITE, WHICH PUT THEM IN CONFLICT, ALL LARGE TRIALS WERE IN CONFLICT AND HAD TO GO TO A SET. THESE A REAL PROBLEM, MAYBE AS GRADUATES BECOME MEMBERS OF (INAUDIBLE). >> CAN I MAKE ONE LAST COMMENT? I WANT TO SAY THE R-21 MECHANISM IS NOT USED AS OFTEN AS IT SHOULD BE IN A AMSCT BECAUSE IT FOCUSES ON WHAT ELIZABETH IS TALKING ABOUT, SMALL GROUP OF SUBJECTS, NO NEEDS FOR PLANNING GRANT, THIS IS PROOF OF CONCEPT. AND THIS IS WHAT WE HAVE TRIED TO PROPAGATE THIS IDEA THAT YOU HAVE AN IDEA PROOF OF CONCEPT, SMALL CLINICAL TRIAL, NOT A CLINICAL TRIALER JUST THE PROOF AND THAT IS THE R-21, IT ISN'T A LOT OF MONEY BUT IT HAS BEEN EXPANDED SLIGHTLY SO THAT IS ONE POSSIBLE ROOT AND WE DO SEE THOSE BUT WE CERTAINLY LIKE TO SEE MORE OF THOSE. >> YOU DO SEE THEM AND THE LAST WORD BY JOENY BECKDALL. >> IN REGARDS TO THE CONFLICT, ALSO IN REGARDS TO THE IDEA THE YOUNGER INVESTIGATOR NEED FEEDBACK IS COMBINING THE TWO TO HAVE A SEPARATE GROUP OF INVESTIGATORS THAT ARE YOUNGER CLINICIANS THAT CAN MAYBE PROVIDE SOME CLINICAL INPUT BUT AT THE SAME TIME RECEIVE TRAINING IN THE WHOLE PROCESS. >> WE'RE VERY CONSCIOUS OF THAT, THANK YOU VERY MUCH FOR THE INPUT ON THIS IMPORTANT DISCUSSION. THIS IS ONGOING FOR A VERY LONG TIME. I HAVE GIVEN THE INTRODUCTION TO THIS NEW PHENOMENAL COMMON FUND EFFORT AND JOAN, DON'T THINK WE HAVE TAKEN TIME FROM YOU BECAUSE WE HAVE PLENTY OF TIME TO GO THROUGH WHAT YOU HAVE PLANNED TO TALK ABOUT. I KNOW JOAN WOULD APPRECIATE FEEDBACK AND CLIFF, YOU ARE WELCOME TO STAY ON ACTUALLY FOR COMMENTS. >> THANKS VERY MUCH, STEVE. IT IS REALLY EXCITING TO FINALLY BE ABLE TO GIVE YOU A PRESENTATION ON THIS. STEVE NOTED THAT WE HAVE BEEN WORKING ON THIS FOR THREE YEARS. I WILL SHOW YOU SOMETHING THAT INDICATES WE HAVE BEEN WORKING ON IT MUCH LONGER THAN THAT. BUT IT HAS A LOT OF PRECONCEPTION EFFORTS THAT WE PUT INTO THIS I WOULD LIKE TO INTRODUCE YOU A LITTLE BIT TO THE COMMON FUNDS, YOU HAVE HEARD ABOUT IT OVER THE YEARS, AT THIS COUNCIL MEETING AND THIS INITIATIVE THAT I'M TALKING ABOUT MOLECULAR TRANSDUCERS OF PHYSICAL ACTIVITY IN HUMANS, AFTER THE LAST COMMON FUND MEET MANY OF US SAW AS THE BIRTHDAY OF THE INITIATIVE ITSELF. COMMON FUNDS IS IN EXISTENCE THIS YEAR WAS THE 10TH ANNIVERSARY CELEBRATION. YOU KNOW WELL MANY EXCITING PROJECTS BUT MOST ESPECIALLY PROMISE THAT WHERE THIS INSTITUTE DR. SERRATE-SZTEIN, DR. WITTER, FILL TONKINS TOOK A -- PHIL TONKINS TOOK A PROMINENT ROLE FOR DECADE LEADING THAT PROMISE INITIATIVE BUT AS WELL READING IN THE NEWSPAPER ABOUT THE MICROBIOME. YOU ALL KNOW MORE ABOUT WHAT'S GOING ON WITH THE BUGS IN YOUR BODY. BECAUSE OF THE POW FOCUS ON THE COMMON FUND MICROBIOME. THERE ARE MANY OTHER TREMENDOUS ADVANCES IN SCIENTIFIC RESEARCH THAT HAVE COME OUT OF THE COMMON FUND. AND WE'RE PART OF THE IT AGAIN. WHAT DO YOU HAVE TO DO TO BE A COMMON FUND PROGRAM? THE MOST IMPORTANT THING, IT HAS HIGH POTENTIAL TO DRAMATICALLY AFFECT BIOMEDICAL OR BEHAVIORAL RESEARCH OVER THE NEXT DECADE AND HAVE A CATALYTIC EFFECT AND THAT IS HAVE MORE LEGS THAN JUST A TEN YEAR INITIATIVE. IT HAS TO ACHIEVE SET OF GOALS WITHIN A DEFINED PERIOD OF TIME AND TEN YEARS IS ABOUT THE TIME LIMIT. EACH ARE GIVEN A MUCH SHORTER PERIOD OF TIME IN ORDER TO SHOW SOME RESULT. THE OUTCOMES HAVE TO SYNERGISTICALLY ADVANCE THE MISSIONS OF THE INDIVIDUAL INSTITUTES AN CENTERS AND BENEFIT HEALTH AREAS THAT CUT ACROSS INSTITUTES AND BE RELEVANT TO MULTIPLE DISEASES AND CONDITIONS. ANOTHER PART THEY HAVE TO BE SUFFICIENTLY COMPLEX THAT IT REQUIRES A COORDINATED TRANS-NIH EFFORT. IF IT CAN BE DONE WITH RFA SOLICITING INVESTIGATOR INITIATED GRANTS, IT'S NOT A COMMON FUND INITIATIVE. BECAUSE IT SHOULD BE SOMETHING THAT NO OTHER ENTITY IS LIKELY TO DO. AS YOU CAN SEE THIS IS A HARD SET OF CRITERIA FOR US TO MEET WHEN WE FIRST STARTED DEVELOPING THE CONCEPT. SOMETHING UNIQUE, TRANSFORMATIVE, SYNERGIST SYNERGISTIC CROSS CUTTING AND CATALYTIC. CAT COUNTRY 98.7LYTIC DELIVERABLES IS THE PASSWORD. THE PUBLIC AND SCIENTIFIC COMMUNITY IS TREMENDOUSLY INTERESTED IN PHYSICAL ACTIVITY DEFINED BY THE CDC IS ANY BODILY MOVEMENT PRODUCED BY THE CONTRACTION OF SKELETAL MUSCLE THAT INCREASES ENERGY EXPENDITURE BEYOND A BASAL LEVEL. SO STANDING VERSUS SITTING. THIS ARTICLE IN THE WASHINGTON POST SHOWING HOW INACTIVITY CHANGES THE BRAIN, FEATURED A PHOTO FROM ONE OF OUR MOTOR PACK WORKING GROUPS. THAT'S HOW WE MET TO PLAN THIS THING. ONE FIRST THING WE DID IS LOOK AT THE NIH PORTFOLIO AND SEE WHAT WAS GOING ON AND AS A RESULT OF THAT, WE SAW THAT THERE IS A LOT OF ATTENTION TO PERFORMANCE, HOW TO ENHANCE THE PERFORMANCE OF YOUR MUSCLES AND ATHLETIC PERFORMANCE BUT MORE WE SAW INSTITUTES WERE VERY INVOLVED IN LOOKING AT THE EFFECT OF DIFFERENT TYPES OF PHYSICAL ACTIVITY ON THEIR PARTICULAR MISSION HEALTH OUTCOME. THE EFFECT ON CARDIOVASCULAR DISEASE, EFFECT ON CANCER, VERY COMMON ACROSS THE HUNDRED IN THE PORTFOLIOS OF THE DIFFERENT INSTITUTES. THE OTHER PART, WHAT CONNECTS THE PHYSICAL ACTIVITY, WHAT ARE THE MECHANISMS, AND MOLECULES THAT ARE ACTUALLY CAUSING THAT ACTIVITY OF SKELETAL MUSCLE TO RESULT IN SOME BENEFICIAL OUTCOME WITH THE GAP AREA WE IDENTIFIED. IT'S A GAP AREA, IT'S NOT BEEN UNEXPLORED BECAUSE WE CERTAINLY WOULDN'T BE ABLE TO PURSUE THIS IF WE COULDN'T STAND ON THE TOP OF A TREMENDOUS INTEREST IN THE SCIENTIFIC IMMUNITY TO PER SUE SOMETHING LIKE THIS. I WILL GIVE AN EXAMPLE, DR. KATZ MENTIONED DR. BRUCE SPEIGLEMAN WHO IS COUNCIL MEMBER OF THE NIDDK AND QUITE A CHAMPION IN THE SCIENTIFIC COMMUNITY OF OUR EFFORTS AND WHO IS INVOLVED IN LOOKING FOR PUNITIVE MOLECULAR TRANSDUCERS. IN 2012 HIS PAPER SHOWING IRISON WHO WOULD BE ASSOCIATED IN MICE WITH ENHANCED PHYSICAL ACTIVITY WAS A CATALYTIC IN ITSELF. THIS SHOWS THE NUMBER OF PUBLICATION ACCUMULATED JUST UNTIL JUNE OF 2015 FROM 2012 AFTER THIS PAPER ABOUT IRISON. WHEN YOU DO SOMETHING THAT REALLY INTERESTS THE SCIENTIFIC COMMUNITY, THAT DOES SPUR REPLICATION BY OTHERS. SO THIS IS ONE OF THE CASES WHERE YOU HAD A LOT OF PAPERS COMING FORWARD, THESE ARE NOT ALL DR. SPEIGLEMAN'S PAPER FOLLOWING UP HIS OWN BUT THE SCIENTIFIC COMMUNITY DIGGING IN, MICE, YEAH, WHAT ABOUT HUMAN? EVEN SOME OF THAT WAS QUITE CRITICAL. IN FACT, THERE WAS ONE ARTICLE SAYING IRISON WAS A MYTH, THAT PAPER WAS JUNE 2015 AND IT BASICALLY IS LOOKING AT THE USE OF ANTIBODIES TO IDENTIFY IRISON IN MICE, HUMANS AND FINDING THAT THE RESULTS WERE VERY SPORADIC AND IN THEIR OPINION NOT CREDIBLE. SO DR. SPEIGLEMAN AND TEAM CERTAINLY TOOK THIS SERIOUSLY AND THEY HAVE GONE BACK AND BOTH DETECTED AND QUANTIFIED CIRCULATING HUMAN IRISON BY MASS SPECTROMETRY SO VERY, VERY CREDIBLE VALIDATION OF THIS. INVESTIGATION AND REPLICATION STUDIES OF THIS ONE MOLECULE WILL CERTAINLY GO ON. THIS AUGUST THERE WAS A PAPER IN THE SCIENTISTS SAYING IRISON REDEEMED. SO I'M SURE THAT PLEASES PEOPLE. BUT TO BRING THE PUBLIC BACK INTO IT, AT AMAZON YOU CAN NOW BUY IRISON. SO IF YOU CAN FIGURE OUT HOW TO USE IRISON PERHAPS INSTEAD OF STANDING OR PHYSICAL ACTIVITY, IT'S THERE FOR YOU AT AMAZON AND SURE IF YOU GO I DIDN'T GO ANY FURTHER BUT SURE IF YOU GO THERE, YOU WILL FIND OUT HOW TO USE IRISON. THIS IS TO SAY THE SCIENTIFIC COMMUNITY IS EXCITED ABOUT THIS TYPE OF RESEARCH. THAT'S THE BACKGROUND FOR MOLECULAR TRANSDUCERS OF PHYSICAL ACTIVITY IN HUMANS. THE 2016 COMMON FUND INITIATIVE HAS THE GOAL TO DISCOVER THE MOST CALLS AND PATHWAYS RESPONSIBLE FOR PHYSICAL ACTIVITY BENEFITS AND THE REASON FOR PURSUING THIS, THE EXPLOITATION OF THESE MOLECULAR MECHANISM MECHANISMS CAN HAVE PAY OFF IN UNDERSTANDING HEALTH BENEFITS, IT'S BEEN HINDERED BY THIS LACK OF KNOWLEDGE ABOUT HOW THE SIGNALING MOLECULES ARE ALTERED BY PHYSICAL ACTIVITY, AND HOW THIS COMMUNICATION NETWORK BETWEEN AND AMONG CELLS OF THE BODY WORKS. WE HAVE 27 INSTITUTES AND CENTERS OF THE NIH. THE LEAD INSTITUTE ON THIS IS DR. KATZ MENTIONED ARE THE DIABETES INSTITUTE, NATIONAL INSTITUTE OF DIABETES, DIGESTIVE AND KIDNEY DISEASES, THE NATIONAL INSTITUTE ON AGING. AND NIAMS. WE CAN'T GO ON WITHOUT SAYING THAT WE HAVE HAD OUR CHAMPIONS IN DR. ROGERS, DR. HODES AND DR. KATZ. WE HAVE HAD A LOT OF GUYS THAT WE HAVE SPOKEN TO TO GET THIS APPROVED AND KEEP IT ROLLING. THESE THREE INDIVIDUALS WERE WORKING WITH THE LEADERSHIP ALL THE TIME. AND WORKING WITH US TO GET A BETTER AND BETTER PRODUCT FOR US TO PRESENT. SO THEY WERE VERY INVOLVED, CRITICAL AS WE MOVE ALONG. WE HAVE QUITE A LOT OF THOSE INSTITUTES STAFF, STAFF FROM THOSE INSTITUTES, INVOLVED IN THIS AND IN THIS PICTURE I SHOW A LITTLE CELEBRATION, TAKE A MOMENT ONCE IN A WHILE AND CELEBRATE SO AFTER THE PRESS RELEASE WE DID HAVE A CELEBRATION, THIS SHOWS MY COLLEAGUE DR. JOHN WILLIAMS FROM THE NATIONAL INSTITUTE ON AGING, AND DR. LOCK LYNN FROM NIDK WHO ARE CRITICAL PARTNERS IN COORDINATION OF THIS MUCH LARGER WORKING GROUP. SO THE WORKING GROUP HAS 39 REPRESENTATIVES FROM INSTITUTES AND CENTERS AS WELL AS THREE OFFICE OF DIRECTOR OFFICES INVOLVED IN THIS. IT IS QUITE A LOT OF PEOPLE HELPING US TO DO WHAT WE HAVE DONE. I HAVE TO SITE A LITTLE HISTORY BACK TO 2010 WHEN AMANDA BOYCE AND GLENN KNUCKLES ARGUE RECOGNIZED A ROUND TABLE, ROUND TABLE SOMETIME DON'T SEE THE EFFECTS IMMEDIATELY, WHAT'S HAPPENED AFTER THEY DISCUSS THIS AT THE ROUND TABLE, WE HAVE ONE ON EXERCISE AND MUSCLE IN 2010. BRINGING UP ISSUES OF HOW DO WE KNOW, WHAT ARE THE MECHANISMS OF EXERCISE AND WHAT STUDIES COULD BE DONE. WE DIDN'T IMMEDIATELY COME UP WITH A PATHWAY, WE CERTAINLY DIDN'T COME UP WITH A PATHWAY NIAMS ALONE COULD GO FORWARD WITH ANY KIND OF INITIATIVE THAT WOULD HELP THIS AREA. AMANDA WAS THERE AT THE BIRTH AND WE PRESENTED THIS AS A COMMON FUND PROPOSAL DUE TO DR. KATZ URGING. IN 2012. YOU SEE THE SMILE FACE, WE RESUBMITTED AGAIN IN 2013 AND THROUGHOUT THIS, THAT SHE NOT ONLY HAS HER HANDS ON THESE SLIDES, I HAVE TO APOLOGIZE TO HER BECAUSE THINGS LIKE BRINGING IN HER PICTURE WERE NOT HER DOING SO ANY MISTAKES YOU SEE IN THESE SLIDES ARE NOT DUE TO JO JONELL BUT THE GOOD CONTENT THROUGHOUT THIS INITIATIVE HAS BEEN HER RIGOR, SHE HELPED WITH PRESENTATION, HELPED WITH PROPOSALS, PUTTING THINGS ON FORMATS YOU WOULDN'T IMAGINE SO SHE'S KEY THROUGHOUT THIS. THE 2013 PROPOSAL MET SOME SUCCESS AND WENT TO THE COUNCIL OF COUNCILS. BODY ADVISES DR. COLLINS ON THINGS THAT ARE CROSS CUTTING. AFTER COUNCIL OF COUNCIL APPROVAL WE GOT THE OPPORTUNITY TO MEET WITH THE IC DIRECTORS, THE INSTITUTE DIRECTORS AND DR. COLLINS AND WE GAVE OUR PRESENTATION AND THAT TIME WE GOT APPROVAL FOR A MEETING. SO BEGAN ORGANIZING A MEETING AND OVER THAT SUMMER, SPRING AND SUMMER WE HAD A SERIES OF WEBINARS THAT INVOLVED MANY FOLKS WHO EVENTUALLY CAME TO THIS WORKSHOP IN OCTOBER OF 14 UNDERSTANDING THE CELLULAR AND MOLECULAR MECHANISMS OF PHYSICAL ACTIVITY INTUESDAYED HEALTH BENEFITS. I THINK IT'S PROBABLY A GOOD THING THAT WE FINALLY GOT A SHORTER NAME. AND THE ACRONYM MOTOR PACK. SO YOU WILL SEE THAT ACRONYM. BEFORE I GET THERE, ANOTHER GREAT ASSET TO US WAS DR. ALEKEL WHO JOINED US FROM THE NCAM INSTITUTE, NOW NCCIH. SHE JOINED NIAMS AS YOU HEARD SIX MONTHS AGO AGO, SHE WOULD KNOW BETTER THAN I TO LEAD OSTEOPOROSIS AND METABOLIC BONE DISEASE PROGRAM. SHE WAS A MEMBER OF THE WORKING GROUP BEFORE THAT. AND SINCE THAT TIME SHE AND AMANDA AND JONELL HAVE WORKED TIRELESSLY ON DIFFERENT PROPOSALS AND FINALLY WHEN WE GOT APPROVAL THEY WORKED ON DEVELOPING FUNDING OPPORTUNITIES ANNOUNCEMENTS. WOULD BE THE CULMINATION OF THIS WHOLE THING. SO THE MEETING THAT WE HAD WAS DEVELOPED INTO A WHITE PAPER AND THAT THAT WHITE PAPER HAS PRESENTATIONS AN DISCUSSIONS THAT ARE DISTILLATIONS OF THE WEBINARS OVER THE SUMMER SO ANATOMY OF AN INITIATIVE, AND I'M SURE MANY COMMON FUND INITIATIVES HAVE WORKED THIS WAY. YOU GET LITTLE BABY STEPS AND YOU CAN BE PULLED BACK AT ANY MOMENT. SO THE PRESENTATIONS COVER THE CHALLENGES THAT ARE BY INTEGRATIVE INTERMITTENT NATURE OF ACTIVITY BUT ALSO EMPHASIZE TREMENDOUS POTENTIAL APPLYING OMICS TECHNOLOGIES TO UNDERSTAND INTER-ORGAN CROSS TALK. BECAUSE WE'RE STANDING ON TOP OF A LOT OF OTHER COMMON FUND INITIATIVES IN METABALOMICS, EPIGENOMICS, TRANSCRIPT OMICS THAT WASN'T RIPE, SHALL WE SAY, FIVE OR TEN YEARS AGO BUT IS REALLY RIPE NOW FOR EXPLOITATION. IT IS CLEAR WE NEED A CLINICAL INFRASTRUCTURE IF WE'RE GOING TO COLLECT SAMPLES FROM HUMANS WE HAVE TO HAVE SOME HUMAN VOLUNTEERS AND IT WILL HAVE TO BE ADEQUATELY SIZED IN ORDER TO COLLECT THESE SAMPLES AND MAKE A MOLECULAR MAP OUT OF THEM. THIS PARTICULAR ARTICLE WAS PUBLISHED IN THE JULY ISSUE OF CELL METABOLISM AND NIH SCORED THE COVER. YOU MIGHT REMEMBER JULY WAS THE WOMAN'S WORLD CUP. SHE PUTS THE SOCKER BALL IN THE GOAL. JONELL AND A TALENTED ARTIST IN THE CLINICAL CENTER HAD A BIG ROLE IN DEVELOPING THIS COVER OF JULY CELL METABOLISM. WHAT WERE THE DELIVERABLES? FROM THAT MEETING, WE IDENTIFIED A LOT OF DELIVERABLES FOR A MAP OF MOLECULAR TRANSDUCERS. AND NOT JUST PEPTIDES AND PROTEINS BUT POST TRANSLATIONAL MODIFICATIONS, NON-CODING NUCLEIC ACID, LIPIDS EPIGENETIC CHANGES CARBOHYDRATES EVEN AND CHEMICAL MESSENGERS. THESE PATHWAYS ARE VERY LIKELY TO BE VERY COMPLICATED BECAUSE THEY'RE INFLUENCED BY YOUR ACTIVITY LEVEL WHETHER IT'S NOVEL, WHETHER YOU'RE SEDENTARY EXERCISING FOR THE FIRST TIME OR ARE YOU A MORE EXPERIENCED EXERCISER OR ATHLETE, WHETHER THE EXERCISES ENDURANCE OR DISTANCE AND WHETHER IT'S LOW OR HIGH INTENSITY, LAYERED ON THAT THE PERSONAL CHARACTERISTICS OF A HUMAN, THEIR AGE, FINANCE LEVEL, -- FITNESS LEVEL THEIR SEX, SO A MAP IS GOING TO REQUIRE A DIVERSE POPULATION OF HUMANS, SEVERAL DIFFERENT TISSUES AND A LARGE POPULATION OF HUMANS APPROXIMATE ALSO WILL REQUIRE THE INVOLVEMENT OF SOME ANIMAL EXPERIMENTERS WHO CAN AD JUDGETIVELY TEST SOMETHING, A GREAT EXAMPLE IN ORGANS THAT YOU'RE NOT WILLING TO GIVE UP AND P HAVE TESTED LIKE THE BRAIN, THE LIVER, THINKING SKIN, FAT, CERTAINLY OR BLOOD PEOPLE WOULD BE WILLING TO DONATE. BUT WE NEED THE ANIMAL FOR TISSUE THAT ARE NOT ACCESSIBLE IN HUMANS. BIG THE CELEBRATION FOLLOWED JUNE 11th FOLLOWED BY THE RELEASE OF THE PRESS RELEASE TO THE WORLD THAT THIS WAS GOING TO GO FORWARD, AND THE ELEMENTS OF THAT PRESS RELEASE ARE REALLY THE BASIS OF THIS TALK. SO IF YOU THINK YOU'RE NOT GETTING AND IN DEPTH UNDERSTANDING OF EXACTLY WHAT WE'RE GOING TO DO, THAT'S CORRECT. BECAUSE WE HAVEN'T ANNOUNCED TO THE SCIENTIFIC COMMUNITY, TO THE PUBLIC, EXACTLY WHAT WE'RE GOING TO BE ASKING FOR. THE PRESS RELEASE SAID THIS WILL COVER FISCAL YEARS 16 THROUGH 21. 16 IS COMING FOR US OCTOBER 1. THE TOTAL AMOUNT WE HAVE TO DEVOTE TO THIS IS ABOUT $170 MILLION. AND OUR GOALS WILL BE TO MAP THE MOLECULAR CHANGES THAT OCCUR AFTER PHYSICAL ACTIVITY IN HUMANS AND PLACE ALL THAT INFORMATION IN A USER-FRIENDLY DATABASE. THAT'S WHAT'S GOING TO GIVE THIS INITIATIVE THE LEGS. THAT HYPOTHESES CEASE WILL BE TESTED DURING THE STUDY FOR SURE. THE MOLECULAR MAP WILL BE DEVELOPED BUT THEY WILL ALSO BE SAMPLED FOR INVESTIGATORS TO DRAW UPON TO HAVE MORE A BOUNCE TO THIS PARTICULAR INITIATIVE THIS WILL INVOLVE ALL HUMAN VOLUNTEERS, SOME ANNALS -- ANIMALS SPECIFIC PROTOCOLS AND A LOT OF SAMPLES, SAMPLES WILL BE CHECKED OVER A TIME SPAN, SAMPLES WILL INCLUDE DIFFERENT TYPES OF TISSUES THAT WE CAN GET FROM HUMANS. THIS WILL INVOLVE CHILDREN AS WELL AS ADULT HUMAN SUBJECTS. SO IT WILL BE A LOT OF SAMPLES A LOT OF THAT INCLUDES A ROBUST BIOINFORMATICS AND SYSTEMS BIOLOGY APPROACH. WILL BE THIS MOLECULAR MAP. THAT IS THE ULTIMATE DELIVERABLE THAT WE CAN GET FROM THIS. SO THE NEXT STEP WILL BE THE FUNDING OPPORTUNITY ANNOUNCEMENT S. THERE IS A COMMON FUND WEBSITE FOR MOLECULAR TRANSDUCERS AND STAY TUNED. THANK YOU. [APPLAUSE] >> THOSE THAT DON'T KNOW THIS IS HAS BEEN AN ENORMOUS AMOUNT OF EFFORT, AND REVISIONS. IT'S IN ITS A-5 REVISIONS. I THINK IF -- SAID SO IF THE -- THE FINAL ARBITER OF THIS EFFORT IS DR. COLLINS AND I MUST SAY THAT AT THE LAST MEETING WITH HIM, THIS WILL -- I DON'T KNOW WHETHER SHE MENTIONED BUT OBVIOUSLY IT CUTS ACROSS ALL AGE GROUPS BUT AT THE LAST MEETING WITH HIM, HE WAS -- SO ENGAGED THAT HE FELT THAT WE WERE UNDERFUNDING THIS AND AND THOUGHT IT REQUIRED MUCH MORE IN TERMS OF THE OMICS ACTIVITIES. WE WERE PLEASED IT WAS THAT ENTHUSIASM ON HIS PART AND PART OF OTHER OF THE DIRECTORS. LET ME OPEN THE FLOOR FOR QUESTIONS OR COMMENTS. FIRST LET ME OPEN THE FLOOR TO PEOPLE ON THE PHONE. >> STEVE, I WANT TO CONGRATULATE JOAN AND NIAMS, THIS IS A SPECTACULAR EFFORT AND THERE IS A HUGE NEED FOR THIS, THE RESPONSE IN THE RESEARCH COMMUNITY WILL BE OVERWHELMING. >> GREAT. THANK YOU FOR THAT. ELIZABETH, ANY COMMENTS? THEN ROUND THE TABLE. >> ELIZABETH, JOAN, THAT WAS GREAT. I JUST -- I THINK THIS IS VERY EXCITING AND TIMELY AND I AGREE WITH CLIFF THIS IS GOING TO BE A HUGE OUTPOURING OF GRANT APPLICATIONS TO FUND THE INITIATIVE. BIG NEW INFORMATION. >> THANK YOU. >> QUESTIONS OR COMMENTS AROUND THE TABLE. JOAN CAN ONLY TALK ABOUT THIS SO FAR. WE'LL KEEP YOU INFORMED AS WE MOVE FROM THIS POINT TO WHAT COMES IN. WE WILL -- WE AS A COUNCIL WILL BE ASKED TO PROVIDE OVERSIGHT FOR SOME OF THESE INITIATIVES BECAUSE THEY WILL BE REVIEWED IN THE NIMS AND COUNCIL -- OUR COUNCIL WILL BE THE SECOND LEVEL REVIEW FOR SOME OF THESE APPLICATIONS. SO STAY TUNED FOR GREATER SPECIFICITY. THANKS VERY MUCH. >> NEXT WE'LL CHANGE OUR ORDER A LITTLE BIT TO ACCOMMODATE TIME. AND AS YOU HAVE HEARD BEFORE WE HAVE THE LUPUS RESEARCH PLAN, THE ACTION PLAN, AND ANITA AND SUSANNAH SERRATE-SZTEIN HAVE BEEN LEADING THE EFFORT AND WILL BRING YOU UP TO DATE BECAUSE WE'RE ALMOST READY TO FLY WITH THIS. >> THANK YOU, VERY MUCH, DR. KATZ. AND AS DR. KATZ MENTIONED DR. SERRATE-SZTEIN AND I ARE GOING TO DO A BIT OF A TAG TEAM PRESENTATION, THIS COUNCIL HAS HEARD A HANDFUL OF TALKS ABOUT THE LUPUS RESEARCH PLAN IN THE PAST BUT QUICKLY RECAP, THE GENESIS OF THIS PARTICULAR DOCUMENT, THE NIAMS IS LEADING IT AS THE CONVENER OF THE FEDERAL WORKING GROUP ON LUPUS, ON BEHALF OF THE ENTIRE NIH DR. KATZ SAID IN HIS OPENING REMARKS SO A LITTLE OVER A YEAR AGO THE CONGRESSIONAL RUE PUS CAUCUS WROTE TO THE NIH AND ASKED THAT WE DEVELOP AN ACTION PLAN FOR LUPUS RESEARCH THAT COULD GUIDE AGENCY INVESTMENT IN THIS DISEASE IN THE COMING YEARS, IT'S BUILDING AN EARLIER RESEARCH PLAN THAT THE NIH PUT FORTH IN 2007. SO YOU WILL HEAR WHEN WE TALK ABOUT THE PROCESS THAT WE HAVE UNDERTAKEN TO DEVELOP THE NEW PLAN WE USE AS THE FOUNDATION FOR IT. THE EARLIER DOCUMENT WHICH SUSANNAH AND HER TEAM PUT TOGETHER SOME YEARS AGO. WE WANTED TO START THIS MORNING'S OVERVIEW OF THE LUPUS RESEARCH PLAN BY REMINDING THE THE COUNCIL HOW WE TEND TO USE A CROSS CUTTING DOCUMENT OF THIS NATURE. THERE ARE OF COURSE MANY INSTITUTES AND CENTERS AT THE NIH THAT HAVE AN INTEREST AND INVESTMENT IN LIEU PUS RESEARCH. ONCE THE PLAN IS FINALIZED, IT WILL PROVIDE A VERY BROAD OUTLINE OF THE SCIENTIFIC COMMUNITY CAN USE IN THINKING ABOUT FUTURE OPPORTUNITIES FOR LUPUS RESEARCH ACROSS THE BASIC TRANSLATIONAL AND CLINICAL RESEARCH ARENAS. WE IMPORTANTLY DO USE THIS TO COMMUNICATE THE AGENCIES PERSPECTIVES ABOUT THIS PARTICULAR DISEASE AND WHAT WE SEE AS THE NEEDS AND OPPORTUNITIES GOING FORWARD. CERTAINLY WITH THE CONGRESS, RESEARCH COMMUNITY, PATIENT ADVOCACY ORGANIZATIONS AND THE GENERAL PUBLIC. AND HOPE IT WILL BE A USEFUL RESOURCE FOR ALL OF THESE CONSTITUENCIES AND COMMUNITIES THAT ARE INTERESTED IN PROPELLING LUPUS RESEARCH IN THE FUTURE AND CERTAINLY FRAMEWORK TO ENCOURAGE INVESTIGATOR INITIATED APPLICATIONS GOING FORWARD. SO I HAVE TALKED ABOUT THE VERY PARTICIPATORY PROCESS THAT WE HAVE UNDERTAKEN OVER THE PAST MANY MONTHS TO PUT THIS PLAN TOGETHER. THAT INCLUDED SUBSTANTIVE INPUT FROM BOTH INTERNAL NIH EXPERTS IN AUTO-IMMUNITY AND LUPUS AS WELL AS CONSIDERABLE FEEDBACK FROM THE BROADER EXTRAMURAL COMMUNITY. WE ISSUED A REQUEST FOR INFORMATION AT THE OUTSET OF THIS PROCESS TO HELP US RETHINK THE FRAMEWORK, THE SCIENTIFIC FRAMEWORK FOR THE NEW ACTION PLAN AND DR. SERRATE-SZTEIN IS GOING TO TALK MORE IN DEPTH ABOUT THAT. WE ALSO HAD A WEBINAR IN THE SPRING THAT INCLUDED OVER 60 PARTICIPANTS FROM THE EXTRAMURAL RESEARCH COMMUNITY. AGAIN, TO HELP US ARTICULATE NEEDS AND OPPORTUNITIES GOING FORWARD. WE HAVE PUT TOGETHER BASED ON THAT FEEDBACK DRAFT ACTION PLAN. THAT IS CURRENTLY AVAILABLE ON OUR WEBSITE FOR PUBLIC COMMENT AND FEEDBACK. WE HOPE TO DELIVER THE FINAL PLAN TO REQUESTERS, THE CONGRESSIONAL LUPUS CAUCUS LATER THIS YEAR. THROUGHOUT THE PROCESS WE HAVE BEEN DILIGENT KEEPING OUR COLLEAGUES ON CAPITOL HILL APPRISED OF OUR PROGRESS IN TERMS OF DEVELOPING THE PLAN AND THE KIND OF INPUT WE HAVE BEEN RECEIVING FROM VARIOUS CONSTITUENCIES. WE HAVE SPOKEN AT THIS COUNCIL AND IMPORTANTLY LUPUS FEDERAL WORKING GROUP DR. KATZ AND DR. SERRATE-SZTEIN CO-CHAIR VERY MUCH INVOLVED IN THE CONCEPTUALIZATION OF THE DOCUMENT. JUST AS JOAN TALKED ABOUT FEDERAL ACTIVITY INITIATIVE A TRANSAGENCY EFFORT, THE DEVELOPMENT OF THIS PLAN INCLUDED INPUT FROM MANY ASPECTS OF THE NIH. AND HERE WE LIST THE PROCESS WE HAD AS THE PROCESS UNFOLDEDDED ACROSS THE ENTIRE AGENCY. I ALLUDED TO THIS INITIAL REQUEST FOR INFORMATION WE PUT TO THE BROAD SCIENTIFIC COMMUNITY ANCHORED AS I SAID ON THE NEEDS AND OPPORTUNITIES THAT HAD BEEN DESCRIBED IN THE EARLIER LUPUS RESEARCH PLAN HERE WE ARE SHARING AREAS WE SOLICITED FOR INPUT FROM THE BROAD SCIENTIFIC COMMUNITY AS WE WERE THINKING ABOUT HOW THE SCIENTIFIC LANDSCAPE IN LIEU PUS RESEARCH EVOLVED SINCE THE RELEASE OF THE EARLIER DOCUMENT IN 2007. WE GOT A CONSIDERABLE AMOUNT OF INPUT FROM THAT EARLIER REQUEST FOR INFORMATION, WE WERE DELIGHTED WITH THE SUBSTANTIVE FEEDBACK FROM THE BROAD COMMUNITY AND THIS IS A QUICK SNAP SHOT OF THE DIFFERENT AREAS OF INPUT BROKEN OUT BY THE EMPHASIS AREAS INCLUDED IN THAT EARLIER RESEARCH PLAN SO GIVES YOU A SENSE FROM THE INITIAL INPUT WE GOT THE AREAS THAT SEEM TO RISE TO THE TOP IN TERMS OF NEEDS AND OPPORTUNITIES AND WE HAVE ALSO INCLUDED WHICH SEGMENTS OF THE COMMUNITY WE HEARD FROM IN THAT PROCESS. SUSANNAH WILL PICK UP HERE AND TALK ABOUT THE SCIENTIFIC WEBINAR AND HOW WE USE THAT TO SHAPE THE NEW PLAN. >> WE HAD A STRUCTURE WEBINAR AND MAY 27, WITH NUMBER OF PARTICIPANTS FROM THE RESEARCH COMMUNITY AND THE PATIENT ADVOCACY ORGANIZATIONS AND REPRESENTATIVES FROM NIH. WE STRUCTURE IT IN A WAY SO THAT VARIOUS SEGMENTS IN THE WEBINAR TO COVER EACH AREAS WE IDENTIFY AS MAJOR AREAS OF EMPHASIS, BASED ON THE INPUT THAT WE GOT FROM RFI AND COMMUNITY. SO WE ASSIGN A COUPLE OF CO-CHAIRS FROM THE OUTSIDE, OUTSIDE EXPERTS TO GUIDE EACH DISCUSSION FOR EACH SEGMENT AND IF WE GO TO THE NEXT SLIDE. YOU CAN SEE WE HAD A LARGE NUMBER OF PEOPLE, 60 PEOPLE PARTICIPATING IN THE WEBINARS SO BUT THE WEBINAR WAS SUCCESSFUL WE MOVED ALONG WELSHING IT INCLUDED INPUT OF OPPORTUNITY INPUT FOR MANY PARTICIPANTS SO WE FELT THE PARTICIPANTS WERE TRULY ENGAGED. WE PROGRESS IN THESE KEY TOPICS, IDENTIFIED BASED ON THE RFI, RESPONSES TO THE RFI THAT WE HAVE PREVIOUSLY PUBLICIZED. SO BASED ON THE WEBINAR, INPUT FROM THE WEBINAR AND THE COMMENTS ON THE DRAFT PLAN, REVISED PLAN WAS DRAFTED, ORGANIZED ALONG THESE AREAS. THERE ARE SOME AREAS WE EXPECT FEEDBACK ON SUCH AS FOR EXAMPLE, MECHANISMS OF DISEASE, NOT SURPRISING THAT WE HAVE SIGNIFICANT AMOUNT OF YES SEARCH OPPORTUNITIES IN THAT PORTION OF THE PLAN AND IMMUNOLOGY INNATE IMMUNITY BUT THERE ARE SEVERAL AREAS OF THE PLAN SIGNIFICANTLY EXPANDED FROM THE OLD PLAN. WE ARE VERY EXCITED ABOUT THAT BECAUSE WE THINK THAT REFLECTS TRULY OPPORTUNITIES IN TERMS OF TECHNOLOGY AND APPROACHES TO RESEARCH. ONE OF THEM HAS TO DO WITH ETIOLOGY AND PREVENTION AND ENVIRONMENT IN LIEU PUS WHICH IS AN AREA WE HOPE AND WE EXPECT TO SEE GROWTH. CLEARLY BECAUSE ENVIRONMENTAL EXPOSURES CAN BE MEASURED NOW IN MUCH BETTER, WE HAVE BETTER TECHNOLOGIES TO MEASURE THAT IN TISSUES. BUT ALSO BECAUSE OF BIOLOGICAL BASIS FOR RELATIONSHIP BETWEEN ENVIRONMENTAL EXPOSURES AND DISEASE MECHANISMS AND GENETIC DISPOSITIONS BETTER UNDERSTOOD SO FOCUSES ON THAT AND IT ALSO HAS EXPANDED THE AREA OF EPIGENOMICS AND GENETICS TO REFLECT THAT. VERY INTERESTING AREA WE RECEIVE SIGNIFICANT INPUT AND SUGGESTIONS FOR OPPORTUNITIES TO DO WITH DIAGNOSIS AND CLINICAL CARE WHICH HAVEN'T BEEN EMPHASIZED IN THE PREVIOUS PLAN. THE COMMUNITY FEELS THERE ARE RESEARCH OPPORTUNITIES THERE, TO HAVE CLINICIANS MANAGE PATIENTS OF LUPUS STARTING FROM THE CONCEPT AND LUPUS IS NOT A SINGLE DISEASE, MULTIPLE FEEDERS OF DISEASE THAT PERHAPS HAVE TO BE MANAGED DIFFERENTLY, WITH NOT ONLY DISEASE -- BEING ABLE TO PREDICT TO SOME EXTHE TENT THE DISEASE COURSE AND THAT SHOULD TAYLOR TO SOME EXTENT TREATMENT SO THERE IS AN EXPECTATION THAT THE PLAN WILL INCLUDES -- THE PLAN DOES INCLUDE IS SEVERAL OPPORTUNITIES THERE AND WE HOPE TO SEE MORE RESEARCH ALONG THOSE LINES. IN ADDITION TO THAT WE ALSO HAVE ADDITIONAL ONLY FA IS ON AREAS OF PSYCHOSOCIAL RESEARCH AND AREA OF PATIENT REPORTED OUTCOMES AND THAT WE EXPECT INCREASINGLY TO SEE THAT ASPECT MORE HEAVILY REPRESENTED IN THE RESEARCH PORTFOLIO. AS WELL AS SPECIAL RESEARCH SPECIAL POPULATIONS. DISADVANTAGED POPULATIONS. SO WE'RE REALLY EXCITED ABOUT ABOUT ALL THOSE AREAS. THERE'S CONTINUED EMPHASIS ON CREATION OF EVIDENCE THAT LEAD DEVELOPMENT OF FUTURE CLINICAL TRIALS, AND EMPHASIS ON APPROACH TO COLLABORATIVE APPROACHES TO THE PREFERRED OR METHOD OF RESEARCH THAT SHOULD BE PRIORITIZED BECAUSE THERE ARE CRITICAL RESOURCES THAT ARE AVAILABLE IN TERMS OF PATIENT POPULATIONS COHORTS AND SPECIMENS IN THE COMMUNITY FEELS SHOULD BE TAKEN ADVANTAGE OF BUT PERHAPS IN COLLABORATIVE FASHION AS OPPOSED TO INDIVIDUAL LABORATORIES WORKING ON THEIR OWN KEY RESOURCES. SO I THINK YOU WILL SEE, LOOK AT THE PLANS, THOSE AREAS ARE NEW, SOMEWHAT NEW EMPHASIS ARE INDICATED AND WE HOPE TO GET MORE FEEDBACK BASED ON THE PLAN THAT IS OUT THERE AND WE WILL BE REVISING ACCORDINGLY BUT WE ARE IN THE LAST SPACE. RIGHT ANITA? >> THAT'S RIGHT. WE ARE IN THE HOME STRETCH SO AGAIN, THE SECOND REQUEST FOR INFORMATION IS CURRENTLY POSTED ON OUR WEBSITE AS WELL AS THE WEBSITE OF OUR SIBBING INSTITUTES AND CENTERS THAT HELPED US TO PUT THIS DOCUMENT TOGETHER AS WITH EARLIER RFI WE'RE LOOKING FORWARD TO AND WE HAVE ALREADY RECEIVED CONSIDERABLE INPUT FROM A CROSS SECTION OF OUR COMMUNITIES OF INTEREST, THE DEADLINE IS THIS FRIDAY SO THERE ARE STILL FEW DAYS LEFT FOR FOLKS TO GET INPUT EITHER ON THEIR OWN BEHALF AS INDIVIDUALS OR IF YOU ARE PART OF SCIENTIFIC SOCIETY PROFESSIONAL ORGANIZATION, SO ON, WE'RE PARTICULARLY INTERESTED IN HEARING FROM THOSE GROUPS AS WELL. SUSANNAH. >> I REALLY WOULD LIKE TO THANK STEPHANIE RAISE YOUR HAND. RHEA. THEY ARE WORKING IN ANITA'S OFFICE AND MY STAFF. DR. MANCINI AND KATIE MYRON AND THEY HAVE REALLY BEEN CRITICAL, CRUCIAL FOR THE DEVELOPMENT OF THIS PLAN. >> SO I WOULD LIKE TO UNDERSCORE THOSE ACCOLADES AND SAY THAT I THINK THE WAY THESE WEBINARS WERE DONE WAS REALLY THE WEBINAR THAT I PARTICIPATED WAS EXCELLENT BECAUSE I -- NOT BECAUSE I PARTICIPATED BUT BECAUSE OF THE WAY IT WAS ORGANIZED. WE HAD LEADERS AT THE WEBINARS, WE ARE USING WEBINARS BIT MORE THESE DAYS BECAUSE IT OBVIATES TRAVEL AND FAR MORE INCLUSIVE TO USE WEBINARS TO GET RESPONSES FROM THE COMMUNITY, EITHER WE INVITE PEOPLE SPECIFICALLY TO PARTICIPATE IN THE WEBINAR, OR ANNOUNCE THE WEBINAR ALL COMERS CAN PARTICIPATE SO GREAT WAY TO DO BUSINESS, GET INPUT FROM THE COMMUNITY AND WE GOT INPUT ON THIS OTHER QUESTIONS OR COMMENTS? YES. MICHAEL. >> I WOULD LIKE TO ALSO CONGRATULATE THE GROUP INCLUSIVE OPPORTUNITY AND REALLY A TERRIFIC WAY BY WHICH THE COMMUNITY WAS ABLE TO PROVIDE INPUT ABOUT THE OPPORTUNITIES IN THE AREA. A QUESTION I HAVE ABOUT THIS EFFORT GOING FORWARD, WOULD -- RELATES TO THE QUESTION OF PRIORITIZATION OF EFFORTS. THIS IS REALLY A DOCUMENT THAT OUTLINES THE OPPORTUNITIES BUT DOES NOT IN ANY WAY PRESCRIBE A PATHWAY FORWARD OR A RELATIVE PRIORITIZATION OF WHERE PARTICULAR BENEFITS MAY COME BY EMPHASIS IN ONE AREA OR THE OTHER. I'M WONDERING WHETHER THERE MIGHT BE A SECOND PHASE TO THIS WHICH INCLUDES DISCUSSION ABOUT PRIORITIES AND WHERE WE THINK OR THE COMMUNITY THINKS THAT EMPHASIS MIGHT BE PUT TO GAIN THE MOST POTENTIAL BENCH >> WHEN YOU PUT TO IT THE COMMUNITY IN TERMS OF PRIORITIES , OR IF YOU PUT TO THE INSTITUTE IN TERMS OF PRIORITIES YOU FIND EVERYONE HAS THEIR PRIORITIES. SO AS HAPPENED, THIS IS OPEN INFORMATION WITH THE -- I TALKED ABOUT THE AIDS INPUT, THE AIDS SET OF GLOBAL EMPHASIS AREAS, THE AIDS COUNCIL WOULD NOT PUT THINGS IN PRIORITY BECAUSE IT IS REALLY THE SCIENTIFIC OPPORTUNITIES THAT IS MANY WAYS MUCH MORE THE DRIVER THAN THE PRIORITY, IF YOU HAVE A REALLY GREAT OPPORTUNITY TO LEARN SOMETHING IN BASIC MECHANISM RATHER THAN IN A BIOPSYCHOSOCIAL ASPECT, AND IT'S DEEMED TO BE OF IMPORTANCE SCIENTIFICALLY AND DEEMED DOABLE, SOMEBODY ELSE WILL SUPPORT IF IT HAS TO DO WITH KIDNEY, HEART, ET CETERA. SO THAT IS A VERY TOUCH THING TO DO, WE HAVE AVOIDED -- TOUGH THING TO DO, WE AVOIDED THAT IN TERMS OF SETTING PRIORITIES, THAT, THIS, THIS, THIS ARE THE MOST IMPORTANT BECAUSE IT'S REALLY NOT ONLY PRIORITIES BUT IT'S REALLY SCIENTIFIC OPPORTUNITIES THAT ARE THE DRIVER AND WE LEE THAT -- LEAVE THAT TO THE COMMUNITY MAINLY. ANY OTHER COMMENTS ABOUT THAT POINT OR ANY OTHER POINT? THAT POINT IS A POINT THAT UNDERSCORES HOW THIS INSTITUTE IS FUNCTIONING AT LEAST THE LAST 20 YEARS AND PERHAPS LONGER BEFORE I GOT HERE. IF THERE ARE NO COMMENTS WE'RE GOING TO TAKE A BREAK. WE'RE JUST ABOUT ON TIME, DR. TABAK WILL BE HERE IN TEN MINUTES. BUT I WOULD LIKE TO HAVE LIZ SMITH AND CATHY AND MICHELLE AND CHOW JENG OVER TO THIS PART OF THE ROOM. WE'LL TAKE A PICTURE TO COMMEMORATE OUR YEARS TOGETHER. WE'LL COME BACK AT 10:45 HOPEFULLY. >> WHEN I WAS A YOUNG BOY I LEARNED THAT YOU NEVER KEEP THE PRINCIPAL DEPUTY DIRECTOR OF NIH WAITING. >> LAST YEAR? >> LAST YEAR, RIGHT. SO LET ME INTRODUCE LARRY TABAK WHO IS A GOOD FRIEND AND PRINCIPLE DEPUTY DIRECTOR OF NIH. WHO WAS THE DIRECTOR OF NATIONAL INSTITUTE OF DENTAL CRANIOFACIAL RESEARCH FROM 2000 TO 2010. AND THEN BECAME ACTING DEPUTY AND THEN DEPUTY DIRECTOR IN THE OFFICE OF DIRECTOR. LARRY'S BACKGROUND IS AS A DENTIST, DDS FROM COLUMBIA AND Ph.D. FROM THE UNIVERSITY OF BUFFALO. HE'S A -- WHAT WE KNOW AS A GLYCO BIOLOGIST. AND HE WAS THE -- BEFORE HE CAME HERE, HE WAS THE SENIOR ASSOCIATE DEAN FOR RESEARCH AND PROFESSOR DENTISTRY AND BIOCHEMISTRY AND BIOPHYSICS IN THE SCHOOL OF MEDICINE AND DENTISTRY AT THE UNIVERSITY OF ROCHESTER IN NEW YORK. AND FORMER NIH RECIPIENT. SO WE'RE PLEASED THAT YOU'RE GOING TO DO TWO PRESENTATIONS, AGAIN, HE WILL TALK ABOUT THINGS THAT I REFERRED TO IN MY OPENING STATEMENT THAT REALLY HAVE TREMENDOUS IMPACT NIH-WIDE. THANK YOU FOR BEING HERE. >> THANKS, STEVEN. GOOD MORNING, EVERYBODY. SO I HOPE THIS IS BEING HEARD. YES? SO TO BEGIN WITH, BACKGROUND ON NIH STRATEGIC PLAN. WHY NOW ARE WITH WE EMBARKING ON THIS. THE SHORE OF IT IS BECAUSE IT'S IN THE LAW. IN THE SO-CALLED OMNIBUS, IT WAS WRITTEN THAT WE, NIH SUBMIT TO CONGRESS AN NIH-WIDE FIVE YEAR STRATEGIC PLAN, NO LATER THAN ONE YEAR AFTER ENACTMENT WHICH MEANS THIS IS DUE TO THE CONGRESS ON DECEMBER 16th 2015. ADDITIONALLY, I KNOW YOU WILL HEAR LATER THIS MORNING DISCUSSION ABOUT 21st CENTURY CURES ACT. WITHIN THAT PENDING LEGISLATION, THERE IS A DISCUSSION ABOUT WHAT THE STRATEGIC PLAN SHOULD INCLUDE AND IT IS OF INTEREST THEY WANT TONE SURE RARE PEDIATRIC DISEASES REMAIN A PRIORITY AS WELL AS MAINTAINING BIOMEDICAL RESEARCH WORK FORCE. IT'S HELPFUL TO TRY TO ARTICULATE WHAT THE PLAN SHOULD BE AND WHAT IT SHOULD NOT BE. SO THERE ARE NO EXPECTATIONS OUT OF SYNC. THIS SHOULD BE A LIVING DOCUMENT TO HELP GUIDE IN FULFILLING OUR MISSION OVER THE NEXT FIVE YEARS, IT DOESN'T SEEM REASONABLE WITH SCIENCE MOVING AS RAPIDLY AS IT DOES, TO CREATE A STATIC DOCUMENT THAT HOPE THAT IT WOULD BE RELEVANT FOR A FIVE YEAR PERIOD. STRATEGIC PLAN SHOULD ARTICULATE APPROACHES AND OPPORTUNITIES THAT ARE FORWARD-LOOKING AND HOPEFULLY ASPIRATIONAL AND SHOULD IDENTIFY MAJOR TRANS-NIH THEMES THAT ADVANCE BIOMEDICAL RESEARCH. IMPORTANTLY, THE STRATEGIC PLAN SHOULD NOT TRY AND DESCRIBE ALL THE MANY IMPORTANT THINGS THAT NIH DOES OR WILL DO. LESS THE DOCUMENT BECOME JUST OVERWHELMING IN SIZE, AND FINALLY, PERHAPS MOST IMPORTANTLY, THE STRATEGIC PLAN SHOULD NOT ADDRESS THE PRIORITIES OF INDIVIDUAL INSTITUTE CENTERS AND OFFICES SINCE EACH OF THESE HAS THEIR OWN STRATEGIC PLAN. WE WILL LAY FORWARDS AND BACKWARDS TO THESE DOCUMENTS BUT THE STRATEGIC PLAN FOR THE NIH IS MEANT TO BE COMPLIMENTARY TO THE STRATEGIC PLANS OF INSTITUTES OFFICES AND CENTERS AT THE AGENCY. HOW HAVE WE GOT TON THE POINT WHERE WE ARE? INITIALLY WE GATHERED A GROUP OF INSTITUTE AND CENTER DIRECTORS, HASHED AROUND SOME IDEAS, WE THEN ASKED EACH INSTITUTE CENTER AND OFFICE TO PROVIDE US VOLUNTEERS TO FORM A WORKING GROUP, WE HAVE BEEN MEETING WITH THIS GROUP ON A REGULAR BASIS. NMS HAS ONE REPRESENTATIVE ON THIS WORKING GROUP. THIS WORKING GROUP IN PARTICULAR HAS HELPED US WITH DEVELOPING CONTENTS OF THE STRATEGIC PLAN AND EXAMPLES OF RESEARCH ADVANCES WE'RE CALLING CALL OUT BOXES, I WILL SHOW YOU WHAT I MEAN IN A MOMENT. THE NIH DIRECTOR HAS ADVISORY COMMITTEE, THE ADVISORY COMMITTEE O THE NIH DIRECTOR THE ARCCD. WE HAVE MET TWICE WITH THE ACD ABOUT THE PLAN, FIRST DIDN'T GO SO WELL. THE SECOND TIME WENT A LOT BETTER AND WHILE POSITIVE ABOUT THE MOST RECENT FRAMEWORK I WILL SHARE WITH YOU WE DID ADVOCATE ADDITIONAL EMPHASIS ON CONNECTIVITY OF RESEARCH, INCLUSION OF CLINICAL METHODOLOGY IMPORTANT TO DRIVE RESEARCH AGENDA FORWARD, THEY WANTED US TO EMPHASIZE EVEN MORE INSTITUTES RELATED TO DATA SCIENCE AND THEY TOO WANTED DISCUSSION ABOUT WORK FORCE RETENTION. DR. COLLINS IS MONITORING THIS CAREFULLY AND HE'S OVERSEEING THE DEVELOPMENT OF MATERIALS AS WE GO FORWARD. THIS DISPLAYS THE CURRENT FRAMEWORK OF THE STRATEGIC PLAN AND I WILL GO THROUGH EACH IN TURN, THE FIRST IS TYPICAL OVERVIEW YOU WOULD EXPECT ARTICULATING THE MISSION OF THE AGENCY, TRYING TO CAPTURE THE EWE NOOK MOMENT IN BIOMEDICAL RESEARCH TODAY -- UNIQUE MOMENT, TEMPERED WITH CONSTRAINTS THAT CONFRONT THE COMMUNITY AND FACE LOSS OF PURCHASING POWER THE NEXT DECADE OR SO. NEXT ARE AREAS OF OPPORTUNITY THAT APPLY ACROSS BIOMEDICINE. WHAT THE FIGURE ATTEMPTS TO SHOW IS THE ENTERCONNECTIVETY AND THE CONTINUOUS NATURE OF THESE VARIOUS SUBSETS OF SCIENCE, FUNDAMENTAL SCIENCE HEALTH PROMOTION DISEASE PREVENTION, TREATMENTS AND CURE BUS EACH BEGETS THE OTHER. SO -- CURES BUT EACH BEGETS THE OTHER AND HOPEFULLY THAT COMES ACROSS TO YOU. FOR EACH OF THESE AREAS OF OPPORTUNITY WE'LL HAVE A SUCCINCT DESCRIPTION OF EMERGENT OPPORTUNITIES OF WHAT NIH NEEDS TO DO TO GET THERE. WE'LL HIGHLIGHT SPECIFIC EXAMPLES OF BREAK THROUGHS THE SO-CALLED RESEARCH CALL OUTS THAT I MENTIONED EARLIER. WE'LL ALIGN WITH THE HHS STRATEGIC PLAN, WE WILL ALSO TRY AND ARTICULATE WHAT THE ROLE OF NIH IS WITHIN HEALTH AND HUMAN SERVICES. SO WE REGARD THE FUND MEN AL SCIENCE SOME OF THE ELEMENTS WE'RE GOING TO EMPHASIZE, THE FACT THAT CONSEQUENCES FUNDAMENTAL SCIENCE ARE OFTEN UNPREDICTABLE. STAKEHOLDERS, POLICY MAKERS AND ALIKE OFTEN FORGET HOW MUCH SERENDIPITY DRIVES WHAT WE DO. WE WILL TALK ABOUT TECHNOLOGY LEAPS WHICH CATALYZE ADVANCES, ADVANCES IN CLINICAL METHODS AND THEN EMPHASIZE HOW IMPORTANT DATA SCIENCE IS TO EVERYTHING WE DO TODAY. WITH REGARD TO HEALTH PROMOTION AND DISEASE WE'LL EMPHASIZE WHY IT'S IMPORTANT TO STUDY HEALTHY INDIVIDUALS, EVERYBODY JUMPS TO STUDYING PATHOPHYSIOLOGY, WE'LL ARTICULATE THE REASONS WHY ADVANCES IN EARLY DIAGNOSIS AND DETECTION ARE IMPORTANT AND HAVE DESCRIPTION ABOUT THE NEED FOR EVIDENCE BASED ELIMINATION OR REDUCTION IF REALISTIC OF HEALTH DISPARITIES. UNDER TREATMENT AND CURE IT IS POINT TO BE MADE HERE IS INCREASED KNOWLEDGE IS BROKEN DOWN INTO DISEASE BOUNDRIES. A GOOD EXAMPLE IS ONCOGENESIS WHERE WE NO LONGER THINK OF CANCER AS ANATOMICALLY BUT RATHER BY THE SIGNAL TRANSDUCTIONS PATHWAYS ACT ACTIVATED OR DEACTIVATED. THE FACT THAT WE HAVE THESE BOUNDARIES REQUIRES WE NEED NEW PARTNERSHIPS AND THESE COME FROM UNEXPECTED DIRECTIONS. THE DRAFT FRAMEWORK WILL TALK UNIFYING PRINCIPLES HOW NIH SETS PRIORITIES AND HOW IT ENHANCES STEWARDSHIP OF THE FUNDS WE'RE ENTRUSTED WITH. EACH WILL HAVE A DESCRIPTION OF THE CURRENT STATUS, EMERGENT OPPORTUNITIES AND WHAT WE NEED TO REALIZE THESE OPPORTUNITIES THE, HIGHLIGHT SPECIFIC EXAMPLES OF THINGS WE HAVE BEEN ABLE TO ADVANCE IN THESE DOMAINS. WE'LL ALIGN THESE WITH HHS STRATEGIC PLAN. WITH REGARD TO SETTING PRIORITIES THIS IS OF INTENSE INTEREST WITH POLICY MAKERS AND FRANKLY STAKEHOLDERS WOULD LIKE THIS ELIMINATED IN A MORE TRANSPARENT MANNER AS WELL. BY WAY OF EXAMPLE, DISEASE BURDEN IS VERY IMPORTANT, IT'S CERTAINLY NOT THE ONLY FACTOR MAKING A DECISION. WE HAVE TO FOSTER SCIENTIFIC OPPORTUNITIES IN A NIMBLE WAY. WE NEED TO ADVANCE SEARCH OPPORTUNITIES PRESENTED BY RARE DISEASES AND FINALLY WE NEED TO CONSIDER THE VALUE OF ERADICATING A PANDEMIC. WITH REGARD TO STEWARDSHIP, THERE ARE NUMBER OF ELEMENTS HERE. THE NEED TO RECRUIT AND RETAIN OUTSTANDING RESEARCH WORK FORCE THAT IS DIVERSE IN NATURE YOU NEED TO ENCOURAGE INNOVATION, YOU NEED TO OPTIMIZE APPROACHES TO INFORM FUNDING DECISIONS. ENHANCE PARTNERSHIPS ENSURE RIGOR AND REPRODUCIBILITY OF SCIENCE, REDUCE ADMINISTRATIVE BURDEN, ANYBODY WANT TO VOTE AGAINST THAT ONE? O AND NEED TO EMPLOY RISK MANAGEMENT STRATEGIES IN EVERYTHING THAT WE DO. THUS FAR RECEIVE PUBLIC FEEDBACK IN A VARIETY OF WAYS, REQUEST FOR INFORMATION AND WEBINARS ABOUT A THOUSAND PARTICIPANTS ENGAGED IN THIS WAY. I'M VISITING THE NATIONAL ADVISORY COUNCIL 21 INSTITUTE CENTERS OR OFFICES, ONLY 17 MORE TO GO. I RECEIVED SOME FEEDBACK ALREADY BY THESE VARIOUS MEDIA TO EMPHASIZE IMPLEMENTATION SCIENCE, INTERDISCIPLINARITY OF SCIENCE, CHANGE PEER REVIEW AGAIN, ENHANCE WORK FORCE TRAINING AND NEED TO DO SYSTEMS APPROACHES, THERE IS A DISCUSSION RAISE BY MANY WHY WE NEED TO BE MORE EXPLICIT IN INCLUSION BEHAVIORAL AND SOCIAL SCIENCES, AND THE NEED TO HAVE PATIENTS AS PARTNERS, NOT AS SUBJECTS. THAT COMES UP MOST OFTEN, ALSO SPECIFIC SUGGESTIONS AS WELL AS SOME DISEASE SPECIFIC COMMENTS. TIME LINE, WE'RE NOW IN SEPTEMBER. WE ARE GATHERING FEEDBACK FROM VARIOUS NATIONAL ADVISORY COUNCILS, AS YOU CAN SEE THE GOAL WILL BE TO SEND THIS TO THE CONGRESS BY MID DECEMBER 2015. SO WITH THAT I WOULD LIKE TO OPEN THE THIS PART UP FOR DISCUSSION. YOU MAY WANT TO COMMENT ON THE BENEFITS AND DRAW BACKS OF THE FRAMEWORK, MAY WISH TO RAISE ANY TRANS-NIH THEMES THAT HAVEN'T BEEN CAPTURED OR FUTURE OPPORTUNITIES OR EMERGING RESEARCH NEEDS THAT SHOULD BE INCLUDED. SO WITH THAT, STEVE, I WILL TURN IT TO YOU. >> THANKS VERY MUCH, LARRY. WE HAVE A FEW DEANS IN THE GROUP SO I WOULD THINK THEY MIGHT HAVE SOME IMPACT ON THE OR SOMETHING TO SAY ABOUT ADMINISTRATIVE BURDENS WHICH YOU HAVE HEARD A LOT ABOUT, I WILL OPEN IT UP TO THE FLOOR, FIRST PLEASE INTRODUCE YOURSELF BEFORE YOU ASK YOUR QUESTION. GARY. >> GARY KRETSKI FROM WEILL CORNELL. ANYTHING IN THE DOCUMENT ABOUT PUBLIC PRIVATE PARTNERSHIPS? >> YEAH. >> KEY THING FOR ALL OF US TO IN CREASE IMPACT. >> RIGHT. IN FACT, THIS WILL BE UNDER STEWARDSHIP, A REQUIREMENT THAT THE AGENCY SEES FOR ITSELF GOING FORWARD. THIS ALSO ALLUDED TO IN THE FACT THAT BECAUSE WE HAVE THIS BREAK DOWN OF THE TRADITIONAL PATHOBIOLOGY, NOW WE NEED NEW PARTNERS. PARTICULARLY TO FOR PRIVATE SECTOR, GOOD EXAMPLE OF THIS IS THE ACCELERATING MEDICAL PROGRESS, THE AMP WHICH I KNOW MINS IS ENGAGED WITH. NIH, FDA, TEN PHARMA COMPANIES NOT FOR PROFITS ALL WORKING IN PRECOMPETITIVE SPACE, WE NEED MORE OF THOSE THINGS IN A DOCUMENT SHOULD REFLECT THAT. >> LARRY, PERHAPS YOU CAN TALK ABOUT THE CONCERN ABOUT TALKING ABOUT SOME DISEASES AND NOT OTHERS AND HOW OUR STRATEGIC PLAN FROM THE NIH DEALS WITH DISEASE, NOT DISEASE DEALS WITH COMMON DISEASE VERSUS RARE DISEASE. Q. AS YOU PROBABLY OBSERVE THERE'S A PAUCITY OF DETHE SUBSCRIPTION ABOUT ANY SPECIFIC DISEASE OR CONDITION. WE WILL OF COURSE USE EXAMPLES OF RESEARCH PROGRESS THAT MADE MENTION OF SPECIFIC DISEASES AND CONDITIONS BUT THE DOCUMENT IN NO WAY WILL ATTEMPT TO REFLECT THE MYRIAD OF DISEASES AND CONDITIONS THAT NIH DEALS WITH. THAT IS WHAT THE INSTITUTE AND CENTER AND OFFICE STRATEGIC PLANS AND MISSIONS OBVIOUSLY ARE ALL ABOUT. WHAT WE'RE TRYING TO DO WITH THIS DOCUMENT IS WE'RE TRYING TO ARTICULATE OVERARCHING PRINCIPLE S THAT WOULD HOPEFULLY BE APPLICABLE TO DECISION MAKING AS IS REQUIRED TO SUPPORT ALL DISEASES AND ALL CONDITIONS. SO THERE'S NO ATTEMPT MADE TO RE CAPITULATE EVERYTHING IN THE NIMS STRATEGIC PLAN FOR EXAMPLE. IT WOULDN'T BE FEASIBLE OR POSSIBLE BUT RATHER SUPERORDINANT P DECISION MAKING TREES. NOW, WE WILL TRY AND HAVE SOME BALANCE TO TYPES OF EXAMPLES WE POINT TO, WE HAVE MADE SPECIFIC REFERENCE TO THE IMPORTANCE OF SUPPORTING RESEARCH ON RARE DISEASES AND CONDITIONS. SOMETHING THAT I KNOW WOULD RESONATE WITH YOUR COUNCIL GIVEN INTEREST THAT YOUR STAKEHOLDERS HAVE. BUT THAT WILL BE THE EXTENT OF IT, REALLY, TO LOOK AT THE OVERARCHING PRINCIPLES AND THE FACT RARE DISEASES ARE IMPORTANT TO STUDY. >> CINDY. >> INDY MAYO CLINIC. FOLLOW-UP ON STEVE'S QUESTION, I GUESS I WOULD BED IN YOUR THOUGHTS, MAY NOT NECESSARILY BE PART OF THE STRATEGIC PLAN BUT WHAT'S THE BALANCE BETWEEN HISTORICALLY NIH SETTING PRIORITIES AND ALLOCATION OF FUNDS VERSUS AT LEAST THE PERCEPTION THAT SOME OF US HAVE MORE IS BEING LEGISLATEED. THE SPECIFIC QUESTION I GET AT AS AN EXAMPLE IF YOU'RE FUNDED THROUGH NIA FOR EXAMPLE, IF YOU HAVE A ALZHEIMER'S RO-1, THE PAY LINE IS THE 8TH PERCENTILE. WHEREAS IF LISTED AS ALZHEIMER'S IT'S 16 OR 17 PERCENTILE. AND THAT GOES AGAINST THE PHASE OF PEER REVIEW AND OTHER THINGS, WHETHER THAT'S GOING TO BE MORE FREQUENT. >> WE CERTAINLY HOPE NOT. AND THERE HAVE BEEN MOMENTS IN HISTORY WHERE CERTAIN DISEASES AND CONDITIONS HAVE COME TO THE FOREFRONT. LARGELY BECAUSE OF SCIENTIFIC NEED, SCIENTIFIC OPPORTUNITY. PUBLIC HEALTH BURDEN BUT ALSO OBVIOUSLY CATALYZED BY STAKEHOLDER INTEREST WHICH IN TURN TRANSLATES TO CONGRESSIONAL INTEREST. WHEN THAT HAPPENS YOU DO GET ABERRANT UNBALANCED SORTS OF RESULTS. WE TRY VERY HARD BY ARTICULATING OVERARCHING PRINCIPLES HOW TO SMOOTH OR AMELIORATE THOSE CIRCUMSTANCES. BUT YOU ARE QUITE RIGHT, THERE ARE EXAMPLES OF THIS, THE BEST WE CAN DO IS CONTINUE TO CONSIDER NOT ONLY DISEASE BURDEN WHICH OBVIOUSLY HAS TO PLAY AN IMPORTANT ROLE, BUT ALSO WHAT IS THE SCIENTIFIC OPPORTUNITY, HOW CAN WE BEST LEVERAGE THINGS THAT ARE IN EXISTENCE AND ALWAYS KEEP IN MIND THERE MAYBE SOME DISEASE OR CONDITION THAT IS AFFECTING ONLY A SMALL NUMBER OF PEOPLE BUT THAT WHEN YOU ELIMINATE THE -- ILLUMINATE THE UNDERPINNINGS OF THAT, YOU OFTEN OPEN UP A WHOLE NEW FIELD OF INQUIRY THAT INFLUENCES AND GIVES POSITIVE BENEFIT TO FOLKS WITH MORE COMMON DISEASES AND CONDITIONS. IT IS A COMPLICATED CALCULUS, THE INSTITUTE AND CENTERS DEAL WITH THIS EVERY DAY AND THE NIH LEVEL AS YOU POINT OUT, THAT CAN SOMETIMES LEADS TO SOME IMBALANCE. BUT WE TRY AND REBALANCE THINGS. WHERE POSSIBLE. >> AND CONGRESSIONAL, THERE YOU KNOW THERE'S A SPECIAL CONGRESSIONAL ALLOCATION FOR ALZHEIMERS THAT ALLOCATION ENABLED THE PERCENTILE SCORES TO BE AT THE 16th OR 17th PERCENTILE. FOR ALZHEIMER'S DISEASE. >> IF I CAN JUST COMMENT I SOME THINGS YOU MENTIONED THAT I THINK WOULD BE PARTICULARLY IMPORTANT, ONE IS THE STEWARD SHIP AND WORK FORCE DRAWING ON THE PHYSICIAN SCIENTIST REPORT FROM THE NIH BECAUSE I ACTUALLY THINK THAT'S A CRISIS. AND HAVING THAT BE A CENTRAL PART OF THE DOCUMENT WE'RE GOING TO GO NOWHERE IF WE DON'T HAVE PEEP DOLL THE WORK. SECOND PART IS SERENDIPITY AND BEING NIMBLE WHEN THERE'S ANOTHER PANDEMIC WOULD BE GOOD TO BE ABLE TO HAVE THE FLEXIBILITY TO STUDY IT AND DO SOMETHING ABOUT IT. RATHER THAN BEGIN TO DISCUSS IT. >> WE AGREE ON BOTH COUNTS, THERE'S ALMOST UNIVERSAL AGREEMENT ABOUT THE NEED TO STABILIZE BIOMEDICAL RESEARCH WORK FORCE WITH PARTICULAR EMPHASIS ON PHYSICIAN SCIENTIST POOL WHICH IS UNDER GREAT DURESS AND CHALLENGE. THEN IN TERMS OF FLEXIBILITY, YES, ALL YOU NEED TO DO IS POINT TO TRAGEDIES IN WEST AFRICA, TO KNOW HOW VERY IMPORTANT IT IS TO BE ABLE FOR THE WHOLE SCIENTIFIC COMMUNITY TO BE ABLE TO MOBILIZE AND REACT AS RAPIDLY AS POSSIBLE. >> TO THAT POINT IF I COULD ADD AT OUR LAST MEETING WE HAD A LONG DISCUSSION ABOUT THE CLINICAL K AWARDS, I CAN TELL YOU THE INSTITUTE IS IMPLEMENTING CHANGE, THE NIH IS IMPLEMENTING CHANGE AT THE NIH LEVEL AND TRYING TO DO THIS IN CONCERT WITH THEM BUT WE ARE IMPLEMENTING CHANGE THAT WE HEARD HERE IN TERMS OF EMPHASIS ON THOSE CLINICAL K AWARDS. OTHER QUESTIONS OR COMMENTS? IF THERE ARE NONE, LARRY, HOLD THE STAGE. HOLD THAT STAGE. I WANT TO INTRODUCE LARRY TABAK. >> GOING TO UPDATE US ON THE FISCAL YEAR 16 NATIONAL CHILDREN'S STUDY BUT THANK MARY BETH KESTER BEING THE LIAISON ON THE TIER GROUP ON STRATEGIC PLAN AND REFLECTING OUR NIMS INTERESTS. BUT WE ALSO HAVE TWO PEOPLE IN OUR GROUP WHO ARE HELPING IN THIS REGARD, SUSANNA SERRATE-SZTEIN AND MARIE MANCINI WITH THE NATIONAL CHILDREN'S STUDY. LARRY. >> THANKS, STEVE AND THANKS TO STAFF WHO REALLY PLAYED AN IMPORTANT ROLE. BOTH OF THESE EFFORTS. SO THIS IS JUST TO UPDATE YOU ON WHERE WE ARE WITH THE RESOURCES THAT FORMALLY WERE USED FOR THE NATIONAL CHILDREN'S STUDY. JUST QUICKLY TO UPDATE YOU ON THE HISTORY, I THINK MOST OF YOU ARE FAMILIAR WITH THIS, AUTHORIZE THE NATIONAL CHILDREN'S STUDY, VANGUARD PILOT WAS LAUNCHED IN 2009, MAIN STUDY NEVER INITIATED THE INSTITUTE OF MEDICINE REVIEWED THIS AND IDENTIFIED A NUMBER OF CONCERNS ABOUT THE DESIGN OVERSIGHT MANAGEMENT AND STRUCTURE AND COST, DR. COLLINS CONVENED A WORKING GROUP OF ADVISORY COMMITTEE ACD, THEY FOUND THE NCS IS OUTLINED, WASN'T FEASIBLE , AS A RESULT, DR. COLLINS DETERMINEED THAT THE N NCS SHOULD BE DISCONTINUED AT THE END OF 2014. SO WE HAD THE OPPORTUNITY TO DEVELOP A SET OF INITIATIVES FOR FISCAL YEAR 15, AND THIS UPDATES YOU ON WHAT WE DID THIS FISCAL YEAR. P P P I SHOULD POINT OUT THAT AT ONSET WE WEREN'T SURE WHETHER THIS WAS GOING TO BE ONE TIME MONEY OR IF IT WOULD BE REFLECTED IN ONGOING BASE COMMITMENT SO IN PLANNING THE FISCAL YEAR 15 FUNDS WE ASSUMED IT WAS GOING TO BE ONE TIME MONEY. SO AS A RESULT, ALL THESE INITIATIVES ARE SO-CALLED FULLY FUNDED AND REQUIRE AND ALLOW COMMITMENTS. EVERYTHING IS SUPPORTED UP FRONT. THERE ARE THREE INITIATIVES, FIRST TO ENHANCE ENVIRONMENTAL INFLUENCES PEDIATRIC DISEASES INCLUDING CREATION OF VARIOUS SENSOR MONITORING DEVICES, A NATIONAL HEALTH EXPOSURE ANALYSIS RESOURCE LED BY NIAMS VALIDATION OF PEDIATRIC PATIENT REPORTED OUTCOMES IN CHRONIC DISEASES, THIS IS THE CHILDREN'S VERSION OF PROMIS WHICH I'M SURE YOU'RE QUITE FAMILIAR WITH. THE SECOND INITIATIVE IS STUDY INFLUENCE ON ENVIRONMENTAL IN UTERO DEVELOPMENT, WITH A GOAL OF IDENTIFYING THE SO CALLED SEEDS OF FUTURE CONDITIONS AN DISEASE DISEASES, HERE SMALL PROGRAM MAKING USE OF THE PLATFORM HERETOFORE WAS USED BY NCATS AN NIHS TO STUDY HIGH THROUGH PUT TOXICOLOGY MEASUREMENTS TO LOOK AT HOW THIS MAYBE AFFECTING HOW VARIOUS SMALL MOLECULES MAYBE INFECTING DEVELOPMENT, SO THINK ABOUT FOR EXAMPLE ZEBRAFISH AS A MODEL SYSTEM FOR SUCH HIGH THROUGH PUT SCREENING. WE MAINLY TOOK ADVANTAGE OF NICHD HUMAN PLACENTAL PROJECT WHICH WAS ALREADY MUCH IN THE PLANNING STAGE. FINALLY A SMALL INVESTMENT TO HELP EXTEND NIAHS ACTIVITY TO LOOK AT OLDER CHILDREN THAT AFFECT ENVIRONMENTAL HEALTH OF THEIR DEVELOPMENT. WE ARE IN THE MIDST OF DOING A PLAN FOR FY 16 IN CONVERSATIONS WITH CONGRESSIONAL STAFF WE BELIEVE THESE RESOURCES WILL NOW BE PUT WITHIN OUR BASE MAKING PROGRESS GOING FORWARD, TRYING TO TELL YOU HOW WE'RE APPROACHING THIS. BEGINNING BY ASKING EACH INSTITUTE AND CENTER DIRECTOR FOR VOLUNTEERS 16 DIFFERENT INSTITUTES CENTERS AND OFFICES HAVE ONE REPRESENTATIVE, STEVE MENTIONED TO YOU NIMS HAS TWO INDIVIDUALS INVOLVED, THE WHOLE EFFORT CO-LED WITH DR. JANINE CLAYTON, DIRECTOR OF ORWH AND THIS GROUP HAS BEEN ACTIVE HELPING TO DEVELOP DETAILS OF THE PLAN, COORDINATE OUTREACH ACTIVITIES AND NOW IN THE PROCESS OF BEGINNING TO DRAFT FUNDING OPPORTUNITIES ANNOUNCEMENTS. WE RECEIVED FEEDBACK FROM THE IMMUNITY, STAKEHOLDER ROUND TABLE MEETINGS 20 PEDIATRIC ENVIRONMENTAL HEALTH EPI AND OTHER ADVOCACY GROUPS WITH US IN JULY. WE HELD THREE WEBINARS, ROUGHLY 400 PERSONS IN TOTAL PARTICIPATED. WE HAD A REQUEST FOR INFORMATION, WE RECEIVED 190 RESPONSES, HARD TO DO WHERE YOU SAY AT THIS FOR THIS FEEDBACK BUT I WILL TRY. HERE IS A SUMMARY OF COMMENTS REITERATING PREGNANCY AND PRENATAL SHOULD BE A KEY FEATURE, BASIC RESEARCH AND TRAINING, THE IMPORTANCE OF SANITIZING AND HARMONIZING DATA, THERE AN IDEA STATES NETWORK AS PART OF THIS, MOST ARE POSITIVE ABOUT THIS. I WILL ELABORATE IN A MOMENT AND THERE WERE MANY, MANY QUESTIONS ON WHO WOULD BE ELIGIBLE WHICH COHORTS, SO FORTH T. I'LL ELABORATE ON THAT. SO THE OVER ARCHING GOAL OF THE FY 16 PLAN GOING FORWARD, IS TO TAKE ADVANTAGE OF EXISTING STUDIES, TO TAKE ADVANTAGE OF THE EXTANT COHORTS TO INVESTIGATE LONGITUDINAL IMPACT OF PRE- PERI AND POST ENVIRONMENTAL EXPOSURES ON PEDIATRIC OUTCOMES THAT HAVE A HIGH PUBLIC HEALTH IMPACT. SO THE GOAL WILL BE TO SUPPORT MULTIPLE SINNER GISTIC HONG TUESDAYSNAL STUDIES USING EXISTING STUDIES REPRESENTING A RANGE OF ENVIRONMENTAL EXPOSURES SHARING STANDARDIZED RESEARCH QUESTIONS AND FOCUSING ON FOUR CAI PEDIATRIC OUTCOMES WE ENVISION THERE WILL BE A SERIES OF CORE ELEMENTS THAT WILL BE ADDRESSED ACROSS ALL STUDIES SO TYPICAL DEMOGRAPHICS AND DESCRIPTION OF TYPICAL EARLY DEVELOPMENT, THERE HAS BEEN DISCUSSION ONE LOOK AT GENETIC VERSUS EPIGENETIC INFLUENCES AND OF COURSE ENVIRONMENTAL FACTORS. THE FOCUS AREAS DIRECTING OUR ATTENTION TO ARE UPPER AND ROWER AIRWAY MA,, -- AS ASTHMA, DEVELOPMENTAL DEFECT AND NEURAL DEVELOPMENT THINGS SUCH AS AUTISM. BROAD BUT YET FOCUSED. RATHER THAN OPENING IT UP TO OPENING TO YOU WILL THINGS ALL PEOPLE. S FROM DOING THIS PLANS ROBUST ENOUGH TO ADDRESS RACIAL ETHNIC MINORITY HEALTH ISSUES AND THERE IS A BALANCE BETWEEN ROBUST CHARACTERIZATIONS OF ENVIRONMENTAL FACTORS AND HEALTH RELATED END POINTS. BY LEVERAGING EXISTING STUDIES, WE ALSO HELP TO UTILIZE EXISTING TISSUE BANKS COLLECTED ACROSS -- DATA SETS FUND ADDITIONAL ANALYSES, WE THINK THIS CAN SERVE AS A TEST BED VALUE DATING TOOLS AND TECHNOLOGIES FOR EXAMPLE THOSE WE'LL LAUNCH SUPPORT OF THIS FISCAL YEAR FY 15. OBVIOUSLY THIS WILL REQUIRE A SYSTEMS APPROACH TO DEVELOP MULTI-VARIABLE MODELS TO PREDICT DISEASE DEVELOPMENT, ONE COULD ENVISION DOING THINGS LIKE RECRUITING WOMEN DURING THE SUBSEQUENT PREGNANCIES AND COMPARING OUTCOMES FIRST AND SECOND CHILDREN. ADDITIONAL OPPORTUNITY I ALLUDED TO WOULD BE TO CORRECT IDEA STATES NATIONAL PEDIATRIC CLINICAL NETWORK TO HELP ADDRESS GAPS FOR RURAL CHILDREN TO NATIONAL NETWORK EMBEDDED IN IDEAL HOECATION AND LINK THESE -- LOCATIONS AND LINK THESE WITH EXPERTS IN CLINICAL TRIALS LOCATED AROUND THE COUNTRY. WE'RE BEGINNING TO DRAFT SKELETON FUNDING OPPORTUNITY ANNOUNCEMENTS THAT FOCUS ON THE CALL FOR THE USE OF EXTANT COHORTS AND COORDINATING CENTER DATA ANALYTICS CENTER, WE WANT TO LEVERAGE THIS TOOL RESOURCE THAT WE ARE FUNDING FISCAL YEAR 15. CHAIR IS A NATIONAL NETWORK ONE CAN MEASURE BIOLOGICAL SAMPLES. MANY INDIVIDUAL INTERESTED IN ROLE OF ENVIRONMENT AND PEDIATRIC HEALTH OUTCOMES, MASS SPECTROMETRY NEEDED TO MEASURE ENVIRONMENTAL EXPOSURES. WE ARE THINKING ABOUT WHETHER OR NOT ONE NEEDS AN EPIGENETIC CENTER OR GENETICS CENTER FOCUS AREA HUBS FOR HELP WITH COORDINATION AND IDEA PROGRAM IDEA WHICH I MENTIONED TO YOU. IN TERMS OF GOVERNANCE MODELS WE WISH TO RECRUIT PEDIATRIC EPIDEMIOLOGY, WE'RE NOT SURE HOW THE REPORTING THIS IS STILL A WORK IN PROGRESS, WE LOVE YOUR FEEDBACK. THE MOMENT WE'RE THINKING THIS INDIVIDUAL WOULD REPORT O THE NIH DIRECTOR, BOARD OF IC DIRECTORS, EXTERNAL GROUP CONSISTING OF THE PRINCIPLE INVESTIGATORS INDEPENDENT EXPERT S, TRYING TO DECIDE WHERE TO LOCATE THIS, EMBED WITHIN AN INSTITUTE OR CENTER WHICH MAKE IT IS MOST SENSE ONE THIS THEORY EMBED WITHIN OFFICE OF THE DIRECTOR. THOSE OF YOU WHO LIKE PICKTOR REAL REPRESENTATIONS, THIS IS IN DRAFT STRUCTURE LOOKING LIKE AND WITH THAT HERE IS OUR TIME LINE WE ARE IN THE MIDST OF BEGINNING TO CRAFT FUNDING OPPORTUNITY ANNOUNCEMENTS WITH THE GOAL OF GETTING THESE OUT BY THE ENDS OF THE CALENDAR YEAR, VERY BEGINNING OF THE NEW CALENDAR YEAR APPLICATIONS DUE BY 5/1 AND ULTIMATELY THE FUNDING WOULD OCCUR AT THE END OF THE FISCAL YEAR 2016. WITH THAT I WILL STOP AND OPEN UP FOR QUESTIONS OR COMMENTS. >> THANKS VERY MUCH, LARRY. ONE REASON FOR INVITE YOU TO DO THIS SECOND PRESENTATION WAS TO GEAR UP OUR COMMUNITIES THAT ARE PARTICULARLY FOCUSED ON PEDIATRIC DISEASE AND PEDIATRIC HEALTH TO LET THEM KNOW THESE ARE ON THEIR WAY. ARE THERE QUESTIONS OR COMMENTS? CHRISTY? >> CHRISTY SANDBAR FROM STANFORD. MY QUESTION SURROUNDS THE USE OF EXISTING BIOREPOSITORIES AND DATA AND STUFF LIKE THAT. SO I DO KNOW IN STATE OF CALIFORNIA, EVERY BABIES WHEN THEY'RE BORN HAS BLOOD SPECIMENS THAT ARE SAVED, USED FOR RESEARCH, GOES 20 YEARS LATER SOME HUGE REPOSITORY THERE. SO THAT'S GOOD. HOW MANY EXISTING REPOSITORIES EXIST THAT WOULD FLOW INTO THIS? BECAUSE I GOT THE IMPRESSION I WONDER WHETHER IT'S IMPORTANT TO START ACTUALLY DEVELOPING NEW ONES. AS WE GO FORWARDs PERSONALLY IN EPIGENETICS BECAUSE THAT ISN'T SOMETHING WE IMAGINED MANY YEARS AGO. >> YOU ARE RIGHT. THERE WILL BE A RESTRICTED NUMBER OF THESE AVAILABLE ALTHOUGH OTHER STATES HAVE SIMILAR DESIGNS AS CALIFORNIA. WHEN WE SURVEY NIH SUPPORTED STUDIES THERE ARE A FAIR NUMBER THAT HAVE BEEN COLLECTING SPECIMENS, ONE YET TO BE DETERMINED, IS WHETHER OR NOT IT WOULD BE -- MAKE SENSE AND NOT COMPROMISE THE ONGOING STUDY TO BE ABLE TO SHARE, SO FORTH SO IT'S NOT MUTUALLY EXCLUSIVE. THE FACT THAT WE WOULD CERTAINLY RECOMMEND AND ADVOCATE FOR USE OF EXISTING SAMPLE REPOSITORIES DOES NOT PRECLUDE GOING FORWARD COLLECTING NEW MATERIALS. UNENVISION IF A PLACE HAS A BIOREPOSITORY BUT FOR WHATEVER REASON LIMITATIONS DONE HISTORICALLY PERHAPS THE SAME BIOREPOSITORY COULD BE EXPANDED AND USED FOR SUBSEQUENT MATERIALS GOING FORWARD. AGAIN WE HOPE TO LEVERAGE AS MUCH AS WE CAN BUT I CERTAINLY TAKE YOUR POINT. >> I THINK THIS IS VERY EXCITING WORK TO BE DONE AND THANK YOU FOR PUTTING THIS TOGETHER. >> OTHER QUESTIONS OR COMMENTS? CINDY. >> I AGREE, THIS IS REALLY EXCITING THE QUESTION I HAD, AS YOU KNOW THE IOM REPORT ON THE CTSA IS REALLY EMPHASIZED PEDIATRIC AND CHILD HEALTH. WITHIN THE CTSA CONSORTIUM EACH SITE IS BEING ASKED TO DEVELOP INFRASTRUCTURE FOR PEDIATRICS STUDIES AND SETTING UP COLLABORATIONS ACROSS THE NETWORK. SO I'M WONDERING HOW MUCH OF THIS INITIATIVE KIND OF TYING IN TO CTSA NETWORK. YOU HAVE THE INFRASTRUCTURE BEING FUNDED BY NIH TO FACILITATE THESE STUDIES. >> TO THE EXTENT CTSA HAS ALREADY LAUNCHED A PEDIATRIC COHORT OF SOME TYPE CERTAINLY THAT WOULD MAKE PERFECT SENSE TO TRY AND LEVERAGE OFF OF THAT AND COMPETE FOR THESE FUNDS. THE OTHER MODEL WE HEAR STAKEHOLDERS DISCUSSING IS FOR PEOPLE WHO HAVE TRIALS OR STUDIES IN A PARTICULAR AREA BANDING TOGETHER TO CREATE A SYNTHETIC COHORT FROM AMONG ALL EXISTING TRIALS IN THAT PARTICULAR AREA. EITHER MODEL IS PERFECTLY REASONABLE AND NOT MUTUALLY EXCLUSIVE. CERTAINLY WE ENCOURAGE ALL GROUPS THAT HAVE ONGOING CHILDREN'S STUDIES, OR STUDIES OF MOMS. SO YOU COULD ENVISION A STUDY WHERE MOM IS STUDIED OR DAD IS STUDIED BUT NOT THE CHILD, HERE YOU CAN FIND FUNDS STUDY FOR THE CHILD OR APPLY FOR FUNDS TO STUDY THE SECOND CHILD OF RESOURCES -- IF RESOURCES ARE AVAILABLE TO STUDY THE FIRST CHILD SO ANY OF THESE PERMUTATIONS I THINK WOULD BE A GOOD STEP FORWARD. >> OTHER QUESTIONS OR COMMENTS? ONE MORE. JOANIE BECKDAL. >> I WAS WONDERING ON THE OTHER PRESENTATION YOU GIVE, THANK YOU FOR YOUR WORK ON THIS AREA. IS THERE A WAY OR NEED TO FORMALLY PUT IN THE CONCEPT OF REPRODUCIBILITY RESEARCH? I KNOW THAT'S SOMETHING YOU HAVE BEEN INTERESTED IN. >> THAT'S COME UP COUPLE OF TIMES WE WANT INVESTIGATORS TO MAKE THE BEST CASE FOR THE MOST IMPORTANT QUESTIONS THAT THEY WANT TO ANSWER. AND IF THAT IS THE DOMAIN THAT AN INVESTIGATOR WOULD LIKE TO EXPLORE, FOR CERTAIN I'M NOT GOING TO DISUADE THEM FROM DOING THAT. THANK YOU FOR RAISING THAT. >> REPRODUCIBILITY AND PREMISE AND FRANCIS THAT WONDERFUL REVIEW LAST YEAR ON NIH COMMITMENT TO REPRODUCEIBILITY AND PREMISE. LARRY, THANK YOU, VERY MUCH FOR COMING HERE. APPRECIATE IT GREATLY. OUR NEXT SPEAKER IS ANOTHER LONG-TIME COLLEAGUE AT THE NIH, SHE'S BEEN HERE ALL FOUR MONTHS. ADRIENNE HALLETT. SHE KNOW MORRIS ABOUT THE NIH THAN PERHAPS ALL OF US TOGETHER BECAUSE SHE COMES FROM -- KNOWS MORE ABOUT THE NIH THAN PERHAPS ALL OF US TOGETHER SHE'S FROM THE UNITED STATES SENATE COMMITTEE ON APPROPRIATIONS SERVED MOST RECENTLY AS THE SENIOR POLICY ADVISOR AND SHE HAS BEEN HEAVILY INVOLVED -- SHE WAS SENIOR ADVISOR TO SENATE FOR HARKIN, HE WAS SO CRITICAL SO MUCH WHAT GOES ON HERE AND ALSO PROVIDED THAT ADVICE TO SENATOR MCKULSKY ON BIOMEDICAL RESEARCH AND HEALTHCARE AND SHE BRINGS TO THE NIH A WEALTH OF RESOURCES TO THIS POSITION INCLUDING BROAD CONTEXT BUT REALLY SHE KNOWS WHAT'S GOING ON ON THE HILL. WE MAY TALK ABOUT IT BUT SHE KNOWS. HAVING HEARD HER TALK ABOUT THE 21st CENTURY CURES AT ONE O OUR DIRECTORS MEETINGS IT WOULD BE OF INTEREST TO KNOW THOUGH THIS IS NOT LEGISLATION YET. IT IS REALLY IMPORTANT TO KNOW ABOUT THE INs AN OUTS PARTICULARLY FROM THE NIH STANDPOINT SO ADRIENNE I APPRECIATE YOU BEING HERE. >> THAT WAS A KIND SUMMARY OF WHAT I KNOW. IT TOOK ME PROBABLY THREE MONTHS TO FIGURE THE BATHROOMS AND COFFEE SHOPS AT NIH. WHAT I KNOW IS MORE THEORETICAL, SO TO GIVE YOU A LITTLE BIT OF AN UPDATE, I'M GOING TO START WITH HISTORY ON THE 21st CENTURY CURES ACT. YOU ALL PROBABLY HAVE BEEN FOLLOWING THIS THE LAST TWO YEARS, IT STARTED WITH A LOT OF CONVERSATION, THE HOUSE ENERGY AND COMMERCE COMMITTEE WANTS TO PUT FORWARD AN EFFORT TO TRY TO SPEED UP THE DISCOVERY OF CURES. THE 18 YEAR PIPELINE IS TOO LONG FOR THEIR PERSPECTIVE SO THIS IS THEIR COLLECTIVE EFFORT AT DOING THAT. HIGH PRIORITY FOR THE CHAIRMAN. MR. UPTON, SO NOW THAT WE HAVE SEEN THE FINAL PASSAGE OF BILL IN THE HOUSE, THE BILL PASSED THE HOUSE, NOW THE SENATE STARTED THEIR PROCESS. WE'LL TALK FOR A MINUTE IN THE HOUSE BILL SO YOU KNOW ONE-HALF OF THE DISCUSSION SO THAT WILL HAVE A HUGE IMPACT WHATEVER COMES OUT OF THE FINAL PROCESS. IT ESTABLISHES INNOVATION, THIS IS THE THING WE TALK ABOUT, THINK ABOUT CARE ABOUT THE MOST, ONE SET ASIDE A BILLION DOLLARS EACH YEAR FOR FIVE YEARS A LITTLE OVER $8 BILLION MANY TOTAL. THAT'S AN ACCELERATING ADVANCEMENT PROGRAM THAT'S $5 MILLION. THE REASON IT'S PARTICULARLY INTERESTING ONE THING YOU ALL SHOULD KNOW AS NIAMS ADVISORY COUNCIL IS THAT PROJECTS IN THIS ACCELERATING ADVANCEMENT FUND REQUIRE ONE TO ONE MATCH FROM ICs. COMMON FUND LIKE APPROACH. AFTER THAT, 35% OF THE REMAINING FUNDS ARE FOR EARLY STAGE INVESTIGATORS, THAT'S JUST -- I DID THE MATH FOR YOU. EACH YEAR $437.5 MILLION. THAT'S THE MINIMUM WE CAN SPEND ON EARLY STAGE INVESTIGATORS. AT LEAST 20% -- >> OVER AND ABOVE WHAT WE'RE CURRENTLY SPENDING I ASSUME. >> THERE IS A PROVISIONS IN THERE THAT SAYS FUNDS SHOULD -- THEIR INTENTION IS FUNDS SUPPLEMENT BUT NOT SUPPLANT. IT'S NOT CLEAR FROM THE LEGISLATIVE LANGUAGE WHETHER THAT'S TOTAL OR WHETHER THAT APPLIES TO EACH ONE OF THE BREAKBREAK DOWNS SO THAT'S CLEARLY THEIR INTENTION. WHETHER THE LETTER OF THE LAW I'M NOT SO SURE. HIGH RISK HIGH REWARD. 20% REMAINING FUNDS, $250 MILLION EACH YEAR. INTRAMURAL, THERE'S A CAP. SO THE OTHER TWO WERE FLOORS, THIS IS A CAP, MISSOURI THAN $175 MILLION EACH YEAR. ONCE YOU TALLY UP THAT, $1.75 MILLION, THE OTHER AUTHORIZED USES, THERE'S $387.5 MILLION LEFT OVER FOUR -- WHATEVER NIH DECIDES TO DO WITH IT. WE WERE ABLE TO GET THE COMMITTEE INITIALLY IT WAS VERY PRESCRIBED, WE GOT THE COMMITTEE TO BE FAIRLY BROAD. WE CAN DO RESEARCH PROJECT AWARDS, INDIVIDUAL RESEARCH AWARDS, THESE ARE NORMAL THINGS THAT NIH DOES WITH OUR MONEY. SO THERE'S A FAIR AMOUNT OF FLEXIBILITY OVER THOSE FUNDS. THE FUNDS ARE ONE TIME. EACH YEAR FOR FIVE YEARS BUT THE MONEY IS AVAILABLE UNTIL EXPENDED SO WE HAVE TIME TO SIT AND THINK ABOUT AND MAKE PLANS HOW WE USE RESOURCES STRATEGICALLY, THEY DON'T HAVE TO BE USED SEPTEMBER 30th THE WAY THE NORMAL APPROPRIATION WOULD. THE OFFSET FOR THIS BILKER THIS IS WHERE A LOT OF THE CONVERSATION HAPPENS. EVERYBODY TALKS ABOUT WANTING TO GIVE NIH MORE MONEY. THE DETAILS ARE ALWAYS IN WHAT THE OFFSET, WHERE IS THE MONEY COMING FROM, IN THIS BILL, MAJORITY OF THE MONEY COMES FROM SELLING OFF A PORTION OF THE STRATEGIC PETROLEUM RESERVE. WE WILL TALK LATER ABOUT THERE'S BILLS OUT THERE THAT USE THAT OFFSET. IT IS NOT CLEAR, IT IS NOT CLEAR IF THIS BILL WILL REACH THE FINISH LINE BEFORE SOME OF THE OTHER ONES, WHICHEVER BILL REACHES THE LINE FIRST GETS TO USE THE OFFSET. SO A BIT OF A RACE. >> YOU CAN'T USE IT OVER AND OVER AGAIN. >> SHOCKINGLY NOT. THERE ARE A LOT OF OTHER PROVISIONSES CONSIDERED NIH REFORM BILL. SO IT REAUTHORIZES THE NIH, IT ALSO REQUIRES US TO DO A STRATEGIC PLAN, YOU ARE TALKING ABOUT STRATEGIC PLAN, WE WERE ABLE TO WORK WITH THE COMMITTEE TO GET PROVISIONS BROAD ENOUGH SO THAT THE CURRENT PROCESS, WE ARE UNDERGOING NIH WIDE, WOULD BE CONSIDERED FULFILLING THIS REQUIREMENT. HELPFUL BECAUSE IT PUTS US ALL IN LINE, DR. TABAK DOING FOR THE LAST TWO YEARS. DR. KATZ IS INTERESTED TO HEAR THAT THERE'S A FIVE YEAR RENEWABLE TERM FOR IC DIRECTORS. >> VERY INTERESTED. >> VERY INTERESTED. IT REQUIRES US TO CREATE AN ENTERPRISES PROGRAM WITH EXTERNAL BOARD. SOME PEOPLE APPOINTED BY NIH DIRECTOR SOME BY CONGRESS. IT'S A PUBLIC PRIVATE VENTURE. THE SENSE OF CONGRESS. SO ONE OF THE THINGS THAT WE HAVE BEEN TALKING A LOT TO CONGRESS ABOUT AND HOPEFUL THAT THERE WILL BE MOVEMENT ON IS AS YOU MAY HAVE HEARD AFTER THE BIG GSA SCANDAL A COUPLE OF YEARS AGO WITH THE TRAINING CONFERENCE THEY PUT ON IN LAS VEGAS, THERE WERE RESTRICTIONS PUT IN ON GOVERNMENT TRAVEL. THAT'S IMPACTING OUR RESEARCHERS SIGNIFICANTLY IN TERMS OF TRAVEL AND THEIR PARTICIPATION AND CONFERENCES. THERE IS A WILLINGNESS AND INTEREST ON THE PART OF BOTH HOUSE AND SENATE COMMITTEES TO FIND WAYS FOR US TO LIFT THESE RESTRICTIONS ON CERTAIN TYPES OF MEETINGS OR CERTAIN TYPES OF RESEARCHERS, AT THE END OF THE DAY THE HOUSE IS NOT ABLE TO GET SOMETHING MORE MEATY THANS SENSE OF CONGRESS BUT A STAKE IN THE GROUND THEY'RE WILLING TO HAVE THIS CONVERSATION SO THIS MAY SEEM LIKE NOTHING BUT IT'S ACTUALLY I THINK GOING TO BE A VERY HELPFUL STEPPINGSTONE. AND WE ARE TALKING SENATE RIGHT NOW HOW TO MAKE IT MORE MEANINGFUL. Q. CAPSTONE AWARD. THIS IS AN ATTEMPT TO DEAL WITH THE FLOW OF RESEARCHERS, THIS WILL BE AT THE IC LEVEL SO THE CAPSTONE AWARD WILL BE THE DURATION OF THE AWARD, THE AMOUNT OF EACH AWARD, DETERMINED BY THE NIH DIRECTOR. BUT THE ICs ARE GOING TO HAVE INPUT INTO WHAT THAT IS. THE LOAN REPAYMENT PROGRAM, THAT ESTABLISHES A NEW -- WE DON'T HAVE PROVIDE IT BUT WE ARE ABLE TO, IT ALSO RAISES THE CAP. I WANT TO SAY THERE'S SOME CONCERN IN CONGRESS BOTH THE HOUSE AND THE SENATE, AROUND THE DECISION ABOUT IF THERE'S NOT NEW MONEY, HOW DO YOU RAISE THE CAP ON INDIVIDUAL AWARDS? ARE YOU GIVE MORGUE AWARDS, ARE YOU -- GIVING MORE AWARDS, GIVING MORE AWARDS TO SMALLER NUMBER OF PEOPLE. THIS CAP, RAISING THE CAP IS IT TO THE ICs AMONG THEMSELVES TO DECIDE YOU DON'T HAVE TO GO TO THE FULL AMOUNT FIRST YEAR, YOU CAN RAMP IT UP OVER TIME, WHAT YOU DO WITH THOSE AWARDS, THERE IS A FAIR AMOUNT OF FLEXIBILITY BUILT INTO THIS. SO LOOKING FORWARD, THE HOUSE HAS FINISHED THEIR BILL, MR. UPTON IS EAGER TO GET THE BILL ON THE BOOKS HE'S LOOKING AT THE PRESIDENTIAL ELECTION NEXT YEAR THINKING WE DOPE KNOW HOW LONG CONGRESS IS GOING TO BE WORKING BEFORE THE SILLY SEASON ENDS. THE SENATE IS ON A SLOWER PIPELINE, SENATORS ALEXANDER AND MURRAY ARE ON THE HEALTH COMMITTEE NOW. THEY'RE EAGER TO GET A BILL. THAT'S A LITTLE LESS -- MR. UPTON AND PALONE WERE'S TORE HAVE MANDATORY MONEY IN THAT BILL. IT'S NOT CLEAR RIGHT NOW. WE'RE HAVING CONVERSATIONS WITH WITH THE COMMITTEE, MY OFFICE IS ON THE PHONE WITH THEM EVERY DAY. AND ONE OF THE TOPICS IS TO WHAT DEGREE IS THE BILL GOING TO INCLUDE A SEPARATE FUNDING STREAM, SOME ARE DISCRETIONARY APPROPRIATION. WE EXPECT TO SEE THEY WILL PRODUCE A DRAFT, THEY ARE WORKING HARD ON CLARIFYING WHAT THEIR POLICY OBJECTIVES ARE, TO TURN INTO LEGISLATIVE TEXT RIGHT NOW. WE'RE WORKING TO PROVIDE THE TECHNICAL ASSISTANCE. WE'RE HOPING TO SEE S LAYTIVE DRAFT, IN A MONTH OR TWO, HOPING TO HAVE COMMITTEE ACTION LATE IN THE FALL, MAYBE EARLY DECEMBER. AND FINAL ACTION THE SENATE IS LOOKING AT EARLY NEXT YEAR. MR. UPTON CONTINUES TO MAKE COMMENTS THAT HE WOULD LIKE TO SEE THAT EARLIER. IN ADDITION TO 21st CENTURY I THOUGHT IT WOULD BE HELPFUL TO GIVE YOU ALL A MINUTE OR TWO ON WHAT YOU'RE GOING TO READ IN YOUR NEWSPAPERS OVER THE FALL AND HOW THAT IMPACTS NIH AND WHAT NIH IS THINKING ABOUT THAT. YOU PROBABLY READ IN THE NEWSPAPER, SEPTEMBER IS A SHORT MONTH, CONGRESS HAS A LOT TO DO, THEY GOT BACK TODAY OR GETTING BACK TODAY. NOT SURE WHERE THEY ARE RIGHT NOW. IN THE GREEN THOSE ARE THE DAYS, BOTH THE SENATE AND HOUSE ARE IN SESSION, THE SENATE IS IN SESSION ON THE YELLOW DAYS, SO IF YOU LOOK AT THE THINGS THAT THEY HAVE TO DO, THIS WEEK THEY ARE GOING TO BE CONSUMED WITH THE IRAN TREATY. NEXT WEEK THEY HAVE THREE WEEKS, THEY HAVE THREE DAYS OF FULL SESSION WITH BOTH OF THEM AND THE POPE IS THERE ON ONE SO I DONE EXPECT A LOT OF WORK DONE THAT DAY. THEN YOU HAVE A WEEK OFF FOR THE HOUSE, THE SENATE WILL BE IN, THE FISCAL YEAR GOT SHIFTED ON MY SLIDE, I APOLOGIZE, THE FISCAL YEAR DOES NOT END ON THE 24th, IT ENDS ON THE 30th. THAT WOULD GIVE PEOPLE SOME NERVOUSNESS. DON'T TELL THE GRANTS MANAGEMENT PEOPLE THEY WOULD KILL ME. WE ALSO HEARD, WE HAVE THE HIGHWAY BILL THAT IS OUT THERE PERCOLATING WE EXPECT THE SENATE HAD HOPED TO GET SOMETHING DONE BEFORE THE AUGUST RECESS BOTH HOUSE AND SENATE HAD HOPED. THEY PASSED A THREE MONTH EXTENSION, SO THAT WILL BE IN OCTOBER. ASSUMING THAT THE HOUSE AND SENATE DON'T WRAP THE SPENDING DECISIONS BY SEPTEMBER 30th I ASSUME THEY WILL NOT, THERE WILL BE A SHORT TERM CONTINUING RESOLUTION. WHEN THAT GOES TO WHAT THE NEW DEADLINE WILL BE, IF ANYBODY IS GUESSED -- IS ANYBODY'S GUESS NOW, A TYPICAL EXTENSION WILL GO THROUGH NOVEMBER OR EVEN UP UNTIL CHRISTMAS. DECEMBER 24th IS A NORMAL DAY FOR THAT. THE QUESTION IS TO WHAT EXTENT DO THEY WANT TO HAVE A DEAL WRAPPED INTO THE SEPTEMBER 30th EXTENSION. IF THEY WANT TO GET A DEAL BUT DON'T HAVE TIME, THEY MIGHT DO A SHORTER EXTENSION LIKE OCTOBER HOPING TO GIVE A FEW WEEKS TO COME UP WITH MORE DETAILS FOR SPENDING. WE ALSO SAW AN AUGUST 25th CONGRESSIONAL BUDGET OFFICE, WHICH I KNOW YOU ALL READ RELIGIOUSLY THEIR UPDATES. THE COMMERCIAL CAME UP WITH THEIR BASELINE THAT SAID THEY BELIEVE TREASURY IS GOING TO RUN OUT OF CASH. HIT OUR DEBT CEILING MID NOVEMBER. MAYBE EARLY DECEMBER. BUT YOU REALIZE WE HIT THE DEBT CEILING EARLIER THIS SPRING, THE TREASURY HAVE BEEN RELYING ON EXTRAORDINARY MEASURES, THEY HAVE BEEN MOVING MONEY AROUND DOING CASH FLOW MANAGEMENT SINCE THAT TIME, THE QUESTION WHEN THEY RUN OUT OF THOSE EMERGENCY MEASURES. THE CDO EXPECTS THAT TO BE MID NOVEMBER EARLY DECEMBER. IT'S GOING TO BE A VERY BUSY FALL TOE HAVE A LOT OF DECISIONS TO MAKE, AND A LOT OF THEM AROUND MONEY HOW TO EXTENT GOVERNMENT, HIGHWAY BILL, AND TAXING CENTERS. WHAT'S INTERESTING ABOUT THE TAX CODE IS THOUGH THE TAX YEAR IS THE CALENDAR YEAR, THEY DON'T HAVE TO FINISH TAX EXTENDER BUSINESS THE 31st, WHAT THE REAL DEADLINE IS WHEN IRS PUTS OUT THEIR GUIDANCE TO ALL THE PEOPLE WHO PREPARE TAXES. IN THE COUNTRY. THEY LIKE IT DONE BY DECEMBER 31st BECAUSE IRS WANTS TIME TO WRITE THE DOCUMENTS THEY LIKE TO READ THE LAW BEFORE EXPRESSING OPINIONS ON IT. THEY CAN GO A LITTLE BIT PAST THE YEAR. SO THAT BILL I THINK WILL BE IN THE NEXT, YOU'LL HEAR TALK ABOUT IT. IF THERE'S GOING TO BE A BIG -- WHAT MAKES BUDGET PEOPLE NERVOUS IS THE LINEUP OF THE GOVERNMENT FUNDING EXTENSION, HIGHWAY BILL AND THE DEBT CEILING. SO YOU PUT THOSE THREE THINGS TOGETHER, IT'S SORT OF THE MOTHER OF ALL FUNDING CLIFFS. IT'S POSSIBLE THOSE THREE THINGS WILL LINE UP AND THERE WILL BE A MEGA DEAL. IT'S POSSIBLE TO SEE, THE HOPE IS TO SEE SORT OF MURRAY RYAN LIKE APPROACH SO TWO YEARS AGO THERE WAS A CONTINUING RESOLUTION ON SEPTEMBER 30th, THAT SET UP THE MARIE RYAN COMMISSION THAT -- MURRAY RYAN COMMISSION THAT YOU COME UP WITH A PLAN BY NOVEMBER 15th AND THE NOVEMBER 15th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s THAT WANT TO PARTICIPATE THAT WILL LAUNCH PROGRAMS WITH THAT. THAT 1.75 BILLION IS MORE FLEXIBLE AND MORE UNDER OUR CONTROL. ANYBODY NEED A JOKE TO LIGHTEN UP THE MOOD? I FEEL LIKE I'M BEHIND -- THE MOST DEPRESSING SPEAKER. >> I THOUGHT THAT WAS ALL A JOKE. [LAUGHTER] >> IT'S REALLY, IT'S SUCH A CHALLENGE, SUCH A TREMENDOUS CHALLENGE. YOU HAVE TO APPRECIATE THE CHALLENGE, THEY HAVE TREMENDOUS CHALLENGES. I WAS WONDERING WHEN YOU GET PLANNED PARENTHOOD, BUT THAT'S AN ADDED CHALLENGE, IN ADDITION TO ALL THE REST EXTENDERS, ET CETERA. >> IF YOU'RE CURIOUS ABOUT THAT, RIGHT NOW THE LEADERS ARE TRYING TO PROPOSE TO THEIR -- I THINK WHAT'S HAPPENING IS THERE'S REMEMBER IN ADDITION ON THE PART OF CONGRESS THAT THEY WANT TO CONTINUE GOVERNMENT FUNDING, THEY DO NOT WANT TO SHUT DOWN, SO TRYING TO COME UP WITH A SOLUTION THAT IS A TWO PART SOLUTION, THERE IS A PLAN FLOATING OUT THERE THAT THEY DO A RECONCILIATION BILL WHICH IS A PRIVILEGE BILL THEY REQUIRE FEWER VOTES, BUDGET RECONCILIATION DESIGNED TO ACTUALLY REDUCE OUR DEFICIT, THE LEADERSHIP WOULD LIKE TO USE RECONCILIATION TO REPEAL PART OF THE AFFORDABLE CARE ACT, THERE'S A CONVERSATION ABOUT COMING OUT WITH A DRAFT OF THAT. IN SEPTEMBER THAT WOULD INCLUDE A DEFUNDING OF PLANNED PARENT HOOD AND THAT WOULD BE THE VEHICLE FOR THE PLANNED PARENTHOOD CONVERSATION RATHER THAN PR. THAT'S JUST AN IDEA. >> WE'RE NOT GOING TO GET INTO THAT HERE. >> NO. >> ARE THERE ANY QUESTIONS BESIDES THAT ISSUE? IF NOT ADRIENNE THANKS SO MUCH FOR KEEPING US UP TO DATE. PARTICULARLY THE 21st CENTURY CURES. WE HAVE TALKED ABOUT A LOT CRYSTALIZED WHAT IS REALLY IN IT. SO THANK YOU VERY MUCH. THANK YOU FOR FOR ALL OF US. WE'RE NOW GOING TO DO OUR CAP STONE PRESENTATION WHICH IS ON OUR INITIATIVES FOR 2017. AS YOU MAY KNOW, EVERY SEPTEMBER WE TALK ABOUT OUR INITIATIVES FOR NOT THE COMING YEAR BUT THE NEXT YEAR. WE DO THIS IN VERY GENERAL TERMS. NOT GO INTO ANY OF THE SPECIFIC BUS GIVE YOU AN IDEA WHAT'S COME THROUGH OUR DISCUSSIONS WITHIN THE INSTITUTE, OBVIOUSLY LOTS OF INPUT FROM THE EXTRAMURAL COMMUNITY. DR.S SERRATE-SZTEIN AND MCGOWAN, BE PRESENTING THIS. >> SO ONE THING WE HAVE DISCUSSED WITH THE COUNCIL IS THE ENTITIES ON VIEDING OPPORTUNITIES -- ON PROVIDING OPPORTUNITIES FOR NEW INVESTIGATORS IN PARTICULAR WHEN WE TALK ABOUT THE WORK FORCE, THAT WE HAVE HAD DISCUSSIONS ABOUT THE NEED TO SUPPORT INVESTIGATORS WHO ARE ALSO CLINICIANS IN PARTICULAR THE CLINICAL K AWARDEES. YOU KNOW THE INSTITUTE CONDUCTS A K FOR KO-8 AWARDEES AND WE HAVE RECEIVED SIGNIFICANT INPUT FROM THEM ABOUT THE NEEDS AND CHALLENGES IN TERMS OF ESTABLISHING SUCCESSFUL RESEARCH PROJECT AND PROGRAM. WE HAVE DISCUSSIONS HERE ABOUT THE SUCCESS OR THE OR THE OUT COMES OF OUR SMALL RESEARCH PROJECT PROGRAM FOR NEW INVESTIGATORS. SO BASED ON INPUT WE RECEIVED ONE INITIATIVE THAT WE ARE TAKING ON IS THE RECONFIGURATION OF THE SMALL GRANT PROGRAM AND THE POINT HERE IS THAT WE BELIEVE BASED ON DISCUSSIONS THAT TARGETING THE PROGRAM TO THE CLINICAL K AWARDEES WOULD BE AN EFFECTIVE USE OR COMBINATION TO HAVE STRONG FEATURES OF EACH PROGRAM, IN TERMS OF PROVIDING ADDITIONAL FUNDING FOR THE RESEARCH ACTIVITIES OF THE K AWARDEES. SINCE WE KNOW THAT ONE OF THE FACTORS THAT CONTRIBUTE SIGNIFICANTLY TO THEIR ABILITY TO ESTABLISH A RESEARCH PROGRAM. >> ELIZABETH, IF YOU'RE ON THE PHONE I KNOW YOU HAVE BEEN WORKING WITH YOUR RESEARCH COMMUNITY ON MAKING AN EFFORT TO SEE THAT THOSE IN CAREER DEVELOPMENT AWARDS HAVE THE SUPPORT THEY NEED TO LAUNCH THE NEXT STEP. DID YOU HAVE ANY COMMENTS OR THOUGHTS ON THIS? >> I CAN'T SEE THE SLIDE. WHERE IS THE SLIDE ON -- IN THE COUNCIL BOOK? >> THE SLIDE SHOULD BE THERE UNDER INITIATIVES ON THE OPEN SESSION. >> YOU DON'T HAVE IT EITHER. >> I'M SORRY, -- >> BASICALLY IT DESCRIBES THE DESIGN OF NIMS SMALL GRANTS PROGRAM FOR NEW INVESTIGATORS ENGAGED IN CLINICAL RESEARCH. >> AND I SEE IT NOW ON THE VIDEO. I JUST COULDN'T SEE IT AND I DIDN'T FIND IT IN ANIMY COUNCIL ELECTRONIC COUNCIL BOOK SO I DIDN'T HAVE TIME TO GO THROUGH IT BUT AS I RECALL DISCUSSION AT THE LAST COUNCIL MEETING, I'M CORRECT THAT WE WERE -- THINKING OF SUN SETTING THE RO-3 PROGRAM AND DEVELOPING A SMALL GRANT PROGRAM FOR K AWARDEES F. >> YOU ARE PRECISELY CORRECT AND YOU CAPTURED IT IN ONE SENTENCE. >> RIGHT THEN IT WAS GOING TO BE THE LAST COUPLE OF YEARS SO THEY CAN SPECIFICALLY GET MORE PRELIMINARY DATA THAT WOULD HELP THEM BECOME INDEPENDENT. TRANSITION FROM THEIR MENTOR A LITTLE BIT AND GET MORE PRELIMINARY DATA FOR A FIRST RO-1. I THINK THAT THIS IS A GREAT IDEA AND WE'LL BE VERY HELPFUL TO YOUNG PEOPLE -- YOUNG K AWARDEES AND REALLY THEY NEED TO BE VERY MUCH MADE AWAR OF THEM. IN THE APPROPRIATE -- EARLY ON IN THE CASE SO THEY CAN BE PLANNING. I THINK VERY GOOD IDEA. >> GARY. >> CAN I ASK THEN WOULD EXCLUDE KO-1 AWARDEES. THAT'S RIGHT? >> WE DON'T GO INTO GREAT DETAIL WHAT THIS IS. THE EMPHASIS HERE IS ON CLINICAL K AWARDS. >> WE HAD A LOT OF DISCUSSION ABOUT IT, I THINK THE LAST COUNCIL MEETING WE HEARD WHAT THE COUNCIL HAD TO SAY. WE'LL PUT A SPREADSHEET OF THE OTHER INITIATIVES IF ANYONE HAS QUESTIONS, ABOUT THEM, PARTICULARLY WE'RE HAPPY TO LISTEN, THESE WERE ALL IN THE ELECTRONIC COUNCIL BOOK, OBVIOUSLY WE CAN ONLY GO INTO SOME DETAIL ON THESE, WE DON'T TALK ABOUT THE MECHANISMS INVOLVED BUT WE DO TALK ABOUT WHAT THE CONCEPT IS. TONY DO YOU HAVE A QUESTION? >> IS THERE A TIME LINE FOR DEVELOPMENT? >> WE'RE TALKING ABOUT FISCAL YEAR 17. THESE ARE ALL INITIATIVES FOR FISCAL YEAR 17. SO JUST HAD A QUESTION ABOUT THE 3-D MODELS, I KNOW DRPA FUNDED A BUNCH OF PROJECTS RELATED TO THAT NOT LONG AGO. >> DRPA AND NIH, >> AND NIH, SO THE QUESTION, IS THAT -- DO WE FEEL THAT WE NEED MORE BEYOND WHAT THOSE ARE SUPPORTING SPECIFICALLY IN THE MUSCULOSKELETAL DISEASE ARIZONAIA? >> DO YOU WANT TO RESPOND? >> SURE, IT'S A MERIT OF LEVERAGING THE ADVANCES THAT HAVE BEEN MADE BY THE DRPA AND NCATS LED MICROPHYSIOLOGIC SYSTEMS. AND HOPEFULLY BRINGING THEM INTO OUR MISSION AREAS TO SEE OUR TISSUES AND DISEASE PROCESSES BETTER REPRESENTED WITH THAT TECHNOLOGY. CARL BAKER AND FAYE WONING HAVE BEEN VERY INVOLVED WITH THE DRPA NCATS NIH MICROPHYSIOLOGIC SYSTEMS AND THINK THAT WE CAN STAND ON TOP OF THAT INVESTMENT AND BRING MORE INTO ARTHRITIS MUSCULOSKELETAL AND SKIN DISEASES. -- >> JUST A QUESTION, THE CORE CENTERS FOR CLINICAL RESEARCH, ARE THOSE -- WILL THOSE HAVE INVESTIGATIONAL LIKE MANY RO-1s ASSOCIATED WITH THEM? IS THIS ONLY FOR CORE ACTIVITIES? >> THIS IS PERHAPS SUSANNAH -- ALL OF OUR CLINICAL ACTIVITIES ARE UNDERGOING TRANSITION AND THIS IS REALLY MEANT TO FOCUS ON WHAT WE THINK ARE NEEDS. WHAT WE THINK ARE NEEDS OF THE COMMUNITY RATHER THAN OUR CURRENT P-60 PROGRAM, THIS WOULD SUPPLANT THAT P-60 PROGRAM TO FOCUS ON AS WE HAVE CORE CENTERS IN MORE BASIC WORK MP-30s, THIS WOULD FOCUS ON THEM AND WOULD NOT HAVE THESE SMALL CLINICAL TRIALS THAT ARE ASSOCIATED WITH THEM. >> MICHAEL. >> SO GOOD TO SEE P-30, 50 AND 60 PROGRAMS ARE EVOLVING AS DISCUSSED SEVERAL YEARS AGO. IT'S A NICE EVOLUTION. WITH REGARD TO THE 21st CENTURY CURES, ARE THERE ADDITIONAL PROGRAMS THAT WOULD BE -- THAT ARE SITTING WAITING FOR DEVELOPMENT OR IN RESERVE IF YOU WILL? IF THAT FUNDING MECHANISM COMES THROUGH, OR WILL THERE BE AN ENTIRELY NEW EFFORT TO IDENTIFY OTHER AREAS? >> SO ALL I CAN SAY IS WE ARE POISED, WE ARE POISED FOR THE 21st CENTURY CURES. PARTICULARLY POISED IN THAT WE KNEW THIS WAS COMING AROUND, WE KNEW THIS WAS A -- THIS WAS A COOPERATIVE LEVERAGING PROGRAM AND WE HAVE DISCUSSED HERE, INNOVATION AND WHAT MARKS -- INNOVATION SO WE ARE POISED TO TAKE FULL ADVANTAGE OF THAT GOVERNMENT-WIDE INITIATIVE, NIH-WIDE INITIATIVE AND THAT'S WHY YOU DON'T NECESSARILY SEE ANYTHING HERE. THAT ACTUALLY HAVE SEEN IT BEFORE, YOU HAVE -- IT'S 2016 -- CORRECT ME IF I'M WRONG, FOR THE 2016 INITIATIVES I BELIEVE IT WAS IN THERE. SO THESE INITIATIVES ARE REALLY THEORETICAL BASIS, THINGS THAT WE MAY OR MAY NOT DO WITH COUNCIL APPROVAL BUT THAT WAS APPROVED AS I RECALL. HUNG, IS THAT NOT CORRECT? HUNG SAYS YES THAT'S CORRECT. WE ARE PREPARED FOR THAT. OTHER COMMENTS? IF NOT I'M GOING TO ADJOURN THE CLOSED SESSION, THE OPEN SESSION OF THE MEETING. AGAIN, I WOULD ASK ANYONE WHO HAS ATTENDED VIA CONFERENCE EITHER IN REAL TIME OR IN NON-REAL TIME LOOKING LATER TO CONTACT US TELL US HOW TO TO IT BETTER. FROM WE ARE NOT ABLE TO GET INPUT DIRECTLY AT TIME OF MEETINGS BECAUSE THE MEETINGS ARE JAM PACKED WITH INFORMATION. WE WANT TO MAKE SURE WE GET THE FULL FEEDBACK FROM OUR COUNCIL MEMBERS BUT I DO WANT TO GET FEEDBACK FROM THE COMMUNITY WHO ARE TAKING PART IN THIS VISUAL -- VIDEOCAST. WITH THAT, WE'RE GOING TO CLOSE, WE'RE GOING TO COME BACK AT EXACTLY ONE O'CLOCK, COUPLE OF MINUTES BEFORE ONE O'CLOCK AND START WITH A REPORT FROM OUR -- THE CHAIR OF BOARD OF SCIENTIFIC COUNSELORS, JAMES. AND THEN I WILL ASK OUR STAFF TO COME BACK AT ABOUT 1:20 WE SHOULD BE FINISHED WITH THE REPORT ON OUR BOARD OF SCIENTIFIC COUNSELORS. SO WITH THAT, I HOPE EVERYBODY KNOW WHERE IS TO GO TO LUNCH. AND THANK YOU VERY MUCH FOR YOUR ACTIVE PARTICIPATION.