>> GOOD MORNING, AND WELCOME TO THE 116TH MEETING OF THE NATIONAL INSTITUTES OF HEALTH ADVISORY COMMITTEE TO THE DIRECTOR ACCIDENT WELCOME TO THOSE OF YOU IN THE ROOM AND PEOPLE WHO ARE WATCHING REMOTELY BY VIDEO. A REMINDER OF OUR USUAL LOGISTICAL ITEMS, THIS MEETING IS OPEN TO THE PUBLIC, INCLUDING MEMBERS OF THE PRESS AND IS BEING WEBCAST, THE MEETING IS BEING TRANSCRIBED, SO COUNCILMEMBERS PLEASE SPEAK DIRECTLY INTO THE MICROPHONES WHEN YOU HAVE SOMETHING TO SAY AND PLEASE ALSO TURN OFF THE MICROPHONE AFTER YOU FINISH BECAUSE I THINK THERE THERE'S A LIMIT IN TERMS OF HOW MANY OF THESE CAN BE ON AT THE SAME TIME YOU HAVE MEETING NOTEBOOKS AT YOUR PLACE, THEY SHOULD HAVE ALL THE MATERIALS IN THERE THAT YOU'LL NEED FOR THE NEXT DAY AND A HALF. AT THE CONCLUSION OF THE MEETING WE'LL HAVE THESE MAILED TO YOU SO YOU DON'T HAVE TO SCHLEP THEM HOME UNLESS YOU WOULD LIKE TO. WE'LL TAKE A GROUP PHOTO AT LUNCH TODAY SO BEFORE YOU DASH OFF TO GET A BITE THE LET'S GATHER IN THE CORNER IN THE TRADITIONAL WAY AND GET A PHOTO OAT TAKEN OF THIS DISTINGUISHED GROUP. I WANT TO DIRECT YOUR ATTENTION, THERE WAS A PUBLIC COMMENT RECEIVED LAST EVENING UNDER TAB 18 SO WHEN YOU GET A CHANCE YOU MIGHT LOOK AT THAT. I WILL POINT OUT IN TERMS OF COUNCILMEMBERS, ROY WILSON WILL BE ARRIVING LATE ABOUT 1:20, WHEN HE DOES, HE'LL BE THERE. RICK LIFTON IS ONLY ABLE TO PARTICIPATE ON FRIDAY BY PHONE BECAUSE APPARENTLY TODAY IS ROCKEFELLER'S CONVOCATION AND I GUESS HE SORT OF FELT LIKE HE OUGHT TO BE THERE. WE GET THAT. JAMES HILDRETH UNFORTUNATELY HAD A VERY LAST MINUTE COMPLICATION OF SOME SORT AND WON'T BE ABLE TO JOIN US FOR THIS MEETING WHICH I'M SORRY ABOUT BECAUSE WE LOOKED FORWARD TO HAVING HIM IN PURN. AND WE HAVE ANNE CHURCHILL ON THE PHONE WHO I THINK I HEARD EARLIER SO HOPEFULLY SHE CAN HEAR. ANNE, LET ME CHECK. >> YES, EVERYONE, I CAN HEAR EVERYTHING VERY WELL. >> Francis Collins, MD: OKAY, GREAT. THANK YOU. WELL, REMEMBER THEY DECEMBER MEETING THAT I MENTIONED WE HAD NEW MEMBERS COMING BUT COULDN'T QUITE YET SAY MORE ABOUT THEM BECAUSE OF THE PROCESS WE GO THROUGH IN TERMS OF GETTING APPROVALS, WHICH REQUIRE ACTIONS NOT JUST BY US BUT BY THE DEPARTMENT, AND I'M HAPPY TO SAY WE DO NOW HAVE THOSE FOLKS ON BOARD, AND JUST LET ME SAY A WORD ABOUT THEM. SO ON THE PHONE THIS MORNING AND TOMORROW MORNING, I JUST MENTIONED, ANNE CHURCHLIN, PH-D SHE'S A NEUROSCIENTIST WHO GOT HER DEGREE FROM UCSF BUT IS NOW ASSOCIATE PROFESSOR AT COLD SPRING HARBOR AND SHE'S PART OF THE BRAIN 2.0 WORKING GROUP THAT YOU'LL BE HEARING MORE ABOUT THIS AFTERNOON, ANNE UNABLE TO BE HERE IN PERSON BECAUSE WE DIDN'T GIVE HER A WHOLE LOT OF NOTICE BUT SHE'S LOOKING FORWARD TO BEING HERE IN PERSON IN DECEMBER. ANNE, WELCOME TO YOU. >> THANK YOU VERY MUCH. GREAT PLEASURE TO BE HERE. >> Francis Collins, MD: OVER HERE ON THE FAR SIDE OF THE TABLE, FRANCIS CUSS, WHO IS THE RETIRED EXECUTIVE VICE PRESIDENT , CHIEF SCIENTIFIC OFFICER AND HEAD OF R & D AT BRISTOL-MYERS SQUIBB SOMEBODY I HAD THE PLEASURE OF WORKING WITH SEVERAL YEARS ON THE ACCELERAT ING MEDICINE PARTICIPATE SHIP ARRIVING HERE FOR HIS FIRST OFFICIAL APPEARANCE AS PARTED OF THE ACD, WELCOME, FRANCIS. NOW WE HAVE TWO FRANCISS IN THE ROOM AND EVERYBODY WILL GET CONFUSED. >> WE'LL JUST CALL YOU FRANCIS C >> Francis Collins, MD: DOESN'T WORK EITHER. GOT TO GO ALL THE WAY DOWN. MARK DIBEL, PHYSICIAN, PROFESSOR OF MEDICINE AND CO-FACULTY DIRECTOR FOR GLOBAL HEALTH AND QUALITY AT GEORGETOWN UNIVERSITY , SIGNIFICANT ROLE IN PEPFAR AND MANY OTHER THINGS AND IS PART OF THE WORKING GROUP ON THE MOCK TRIAL WE'LL BE TALKING ABOUT TOARNLINGS WONDERFUL TO HAVE MARK COME AND JOIN US. WELCOME. AND DAVID GLAZ HE R OVER HERE, A REMARKABLE INFORMATICS EXPERT WHO WE HAVE DEPENDED ON IN ALL SORTS OF INTERESTING WAYS IN THE SHAPING AND NOW THE IMPLEMENTATION OF THE ALL OF US PROGRAM, ENGINEERING DIRECTOR FOR VERILY LIFE SCIENCE AND FORM HE WILL GOOGLE. WELCOME TO YOU. UNABLE TO JOIN US FOR THIS MEETING, I'VE ALREADY MENTIONED JAMES HILL DRETH PRESIDENT AND CRE O OF THERE MAHARI, WHO HAD A CONFLICT. AND CHARLES HANSON, WHO WILL BE GOING FORWARD DESCR WORKING FORWARD WITH THE WORKING GROUP K I'LL LOOK FORWARD TO INTRODUCING HIM IN DECEMBER, UNABLE TO BE HERE. AGAIN PERHAPS A ROUND OF APPLAUSE FOR OUR NEW MEMBERS. [APPLAUSE] AND WELCOME TO EVERYBODY AROUND THE ABLE -- AROUND THE TABLE. MAYBE TBLED A USEFUL THING FOR ME TO GO THROUGH A BIT OF THE AGENDA JUST TO SORT OF GIVE YOU A QUICK BIT OF COLOR COMMENTARY ON HOW WE'RE GOING TO SPEND THE NEXT DAY AND A HALF. AGAIN, IT'S BEEN A PRETTY INTENSE SIX MONTHS SINCE LAST WE MET AND THAT'S GOING TO BE REFLECTED BY REPORTS FROM WORKING GROUPS AND OTHER TOPICS THAT WE'RE BRINGING TO YOU TODAY AND TOMORROW. WE WILL START OFF WITH THE ALWAYS ANTICIPATED DIRECTOR'S REPORT, WHICH WILL INCLUDE SOME CAMEO APPEARANCES, ONE FROM TONY FA TU CCI WHO IS HERE AND WILL TELL YOU WHAT'S GOING ON WITH EBOLA AND THE DRC BECAUSE WE'RE IN THE MIDDLE OF THIS OBVIOUSLY INTENSE PUBLIC HEALTH ISSUE, WE'LL ALSO HEAR NEAR THE END OF MY DIRECTOR'S REPORT I'LL ASK NEIL SHAPIRO OUR BUDGET OFFICER TO GIVE YOU EVER THE SKINNY ON WHAT'S HAPPENING IN THE BUDGET PROCESS, BOTH THE ONE WE'RE ALREADY DONE WITH AND THE WORK WE'RE WORKING ON AND THE ONE THAT COMES AFTER THAT, WE'RE ALWAYS IN AT LEAST THREE BUDGET CYCLES AT THE SAME TIME. THEN I'LL ASK ADRIAN HALLET OUR LEGISLATIVE EXPERT TO TALK TO YOU ABOUT THINGS HAPPENING ON THE HILL AND THAT'S ONE OF THOSE CASES WHERE SHE ALWAYS HAS TO CHANGE HER SLIDES A MINUTE BEFORE WE START BECAUSE EVERYTHING IS ALWAYS UP IN THE AIR AND THIS IS NO EXCEPTION THIS YEAR. AFTER THAT, AND AGAIN I HOPE WE'LL HAVE PLENTY OF TIME FOR DISCUSSION AND I'LL ENCOURAGE YOU IN THE COURSE OF THE DIRECTOR'S REPORT TO INTERRUPT ME SO IT DOESN'T TURN INTO A VERY LONG MONOLOGUE, WHICH SOMETIMES HAS HAPPENED, THEN WE'LL TAKE A BREAK, IT DOESN'T SAY THAT IN THE SCHEDULE, BUT BY 10:45 I THINK EVERYBODY WILL BE READY TO STAND UP AND STRETCH AND THEN WE'LL ASK NED SHARPLESS TO TAKE THE ROLE WE HAVE OFTEN 1K-D IN THE COURSE OF AN ACD MEETING TO HAVE AN INSTITUTE DIRECTOR TALK ABOUT WHAT'S HAPPENING IN THEIR PART IN THIS AMAZING INSTITUTION, NED APPEARS THE STILL RELATIVELY NEW DIRECTOR OF THE NCI WILL BRING YOU SOME INTERESTING SCIENCE TO TALK OVER WITH YOU. WE'LL THEN HAVE BY 11:45 A REPORT THAT CARRIE WOLINETZ, WHO IS BOTH ASSOCIATE DIRECTOR FOR SCIENCE POLICY AND ACTING CHIEF OF STAFF WILL TELL YOU ABOUT WHAT WE ARE DOING IN THIS LATEST CYCLE OF REVIEWING APPLICATIONS FOR ACCESS TO THE HELA GENOME SEQUENCE AND REMIND YOU HOW WE GOT TO THIS PARTICULAR PROCESS AND HOW WE'RE CARRYING IT FORWARD. WE'LL THEN HAVE THE GROUP PHOTO AND THEN LUNCH, AND THEN FOLLOWING LUNCH HEAR FROM A WORKING GROUP THAT HOE ZI FLOREZ AND LARRY TABAK HAVE BEEN LEADING ABOUT THE NEXT GENERATION RESEARCHERS, VERY MUCH FOCUSED ON THE IMPORTANCE OF DOING EVERYTHING WE CAN TO ENCOURAGE THE NEXT GENERATION OF RESEARCHERS TO FIND A SATISFYING AND ENCOURAGING EXPIN NOTICE VAI TIVE -- AND INFLOW NOTICE VAI TIVE PATHWAY TOWARDS THEIR OWN CAREERS WHICH WE VERY MUCH WANT TO NURTURE AND ENCOURAGE SINCE THEY'RE OUR MOST IMPORTANT RESOURCES. FOLLOWING THAT, MIKE LAUER WILL GIVE YOU A TOPIC ON WHAT'S HAPPENED IN THE ARE TOPIC OF RIGOR AND REPRODUCIBILITY. THEN A BREAK. 3:00 I SUSPECT WE'LL HAVE A PRETTY INTENSE AND IMPORTANT CONVERSATION ABOUT THE ISSUE OF SEXUAL HARASSMENT AND WHAT NIH IS DOING IN TERMS OF POLICIES AND PROCEDURES IN THIS VERY IMPORTANT TOPIC WHICH IS RIGHTLY RECEIVING A LOT OF ATTENTION, INCLUDING A NATIONAL AKD NATIONAL ACADEMY REPORT THE DAY BEFORE YESTERDAY. AT 3:45 WE'LL HEAR FROM ANOTHER WORKING GROUP THAT BRENDAN LEE AND LARRY TABAK HAVE BEEN CO- LEADING ON HIGH RISK, HIGH REWARD WORKING GROUP, THESE ARE THE PIONEER AWARDS, THE NEW INNOVATOR AWARDS, THE TRANSFORM ATIVE RESEARCH AWARDS EXPERL INDEPENDENCE AWARDS AND ARE WE IN FACT SEEING THE KIND OF OUTCOMES FROM THIS THAT WE DREAMED OF AND ARE WE IN PARTICULAR MAKING THESE PROGRAMS AVAILABLE TO PEOPLE FROM ALL SORTS OF BACKGROUNDS, WE'RE PARTICULARLY CONCERNED ABOUT THE BALANCE HERE IN TERMS OF HAVING MORE WOMEN IN THESE PROGRAMS AND MORE UNDERREPRESENTED GROUPS. YOU'LL HEAR FROM THEM ABOUT THAT 6789 THEN BY 4:15 WALTER KOROSHE TZ, DIRECTOR OF NINDS AND JOSH GORDON DIRECTOR. NIMH, CO-LEADS OF THE NIH BRAIN INITIATIVE WILL COME AND TALK TO YOU ABOUT THE WORKING GROUP FOR BRAIN 2.0 WHICH VOFERLZ ANNE CHURCHILL WHO IS ON THE PHONE AND GIVE YOU A STATUSES REPORT ON WHERE THIS EFFORT IS TO TRY TO REFRESH THE PLAN FOR THE BRAIN INITIATIVE WHICH AS YOU MAY REMEMBER WAS ORIGINALLY PUT TOGETHER BY A WORKING GROUP OF THIS ACD IN THAT CASE LED BY COREY BARGMAN AND BILL NU ST MAN PUT IS FORTH A REMARKABLE REPORT ABOUT WHAT WE MAY BE ABLE TO ACHIEVE BY 2025, ROIFERSING THE SCIENCE CHANGING VERY QUICKLY WE FELT IT'S TIME TOM REFRESH THIS LOOKING AT A NEW GROUP LOOKING AT THESE ISSUES AND WALTER AND JOSH WILL TELL YOU WHERE WE STAND WITH THAT AND WHAT THE PLAN IS FOR ATTEMPTING TO HAVE A NEW VERSION OF THAT INITIATIVE IN ANOTHER YEAR FROM NOW. WE EXPECT WE'LL ADJOURN SOMETIME AROUND 51:25. THRBL A SHUTTLE AVAILABLE AT ABOUT 5:45, WHICH WILL GIVE YOU THE OPPORTUNITY TO COME AND SPEND A LOVELY EVENING AT THE TA BAK HOME. I HAVE IT ON GOOD AUTHORITY THAT LARRY HAS BEEN COOKING FOR THE LAST THREE DAYS, AND HE AND ROBIN WILL HOST ALL OF US ACD MEMBERS AND A FEW MEMBERS OF THE EXECUTIVE COMMITTEE AT THEIR HOME FOR WHAT WE HOPE WILL BE A VERY PLEASANT INFORMAL EVENING ON A BEAUTIFUL EVENING AS WELL. SO MAYBE WE'LL EVEN GET TO BE OUTSIDE A LITTLE BIT. >> A LOT. >> Francis Collins, MD: A LOT, BECAUSE THE HOUSE IS NOT THAT BIG. RIGHT? ANYWAY, WE'LL MAKE SURE TO GET YOU TRANSPORTED THERE. IF ALL GOES WELL, YOU'LL HAVE ABOUT A HALF HOUR BREAK TO DO SOME THINGS LIKE E-MAILS AND PHONE CALLS, THEN THERE WILL BE SHUTTLE BUSES THAT WE'LL TALK ABOUT LATER AT THE C WING TO TAKE YOU. WHEN THAT SAYS OVER, EITHER MEMBERS OF -- WHEN THAT IS OVER, EITHER MEMBERS OF NIH WILL STAFF GET YOU BACK TO THE MARRIOTT OR LARRY IS SUGGESTING WE COULD ALL WALK BECAUSE IT'S ONLY FIVE MINUTES. SO THAT'S SORT OF THE PREVIEW OF TODAY. TOMORROW, FRIDAY, WE'LL START AGAIN AT 9:00, THRBL A QUICK REVIEW OF OUTSIDE AWARDS FOR ACD APPROVAL, LARRY WILL GO THROUGH THAT AND I GUESS RICK LIFTON WILL BE ON THE PHONE AND IS YOUR PARTNER IN THAT. AND LINDA ALSO. SORRY. THEN WE'LL HAVE AN INTENSE OPPORTUNITY TO HEAR FROM MYSELF, FROM WALTER KOROSHETZ ABOUT WHAT NIH IS DOING ABOUT THE OPIOID CRISIS. TIMELY BECAUSE IN TUESDAY OF THIS WEEK WE PUBLISHED A PAPER IN JAMA, OUTLINES A SERIES OF NO LESS THAN 15 INITIATIVES THAT NI H AIMS TO UNDERTAKE WITH COLLABORATORS AND COLLEAGUES BASED UPON THE $500 MILLION A YEAR THAT CONGRESS ALLOCATED FOR THIS PURPOSE IN THE LATEST OMNIBUS BILL WHICH WE TAKE VERY SERIOUSLY AND WANT TO MOVE FORWARD VERY AGGRESSIVELY. SO I'M SURE THERE WILL BE LOTS OF DISCUSSION ABOUT THAT. HAD E-DIVERSE DIVERSITY WORKING GROUP, HANNA AND ROY VALENTINE HAVE BEEN LEADING WILL THEN HAVE AN OPPORTUNITY TO TALK TO YOU ABOUT THE WORK THEY'VE BEEN DOING WHICH I THINK YOU'LL ALSO FIND INTERESTING AND IS A LONG TERM PROJECT OF THIS ACD. THEN FINAL TOPIC AT 11 4R5 WE WILL -- AT 11 4R5 WE WILL DISCUSS THE OUTCOME OF A WORKING GROUP THAT'S INVOLVED LARRY AND MARK AND JAY ON THE MODERATE ALCOHOL AND CARDIOVASCULAR HEALTH TRIAL, WHICH HAS BEEN SOMEWHAT IN THE PRESS AND WHERE WE'VE BEEN ENGAGED IN AN INTENSE INVESTIGATION ON THE RESULTS OF THE WAY IN WHICH THIS PARTICULAR STUDY WAS DESIGNED, AND I THINK YOU'LL ALL FIND THAT TO BE A VERY IMPORTANT CONVERSATION. WE REALLY SEEK THE ACD'S INPUT IN LOOKING AT THE RECOMMENDATION S THAT THAT WORKING GROUP IS GOING TO BRING TO YOU. IF ALL GOES WELL, WE SHOULD WRAP UP BY 12:30 TOMORROW AND GET YOU ON YOUR WAY. SO THAT'S WHAT YOU'RE IN FOR. SO I THOUGHT AS PART OF THE DIRECTOR'S REPORT I MIGHT DO SOME THINGS THAT I'VE DONE BEFORE IN TERMS OF GIVING YOU HIGHLIGHTS OF EVENTS THAT HAVE HAPPENED SINCE WE LAST GATHERED, AND THERE HAVE BEEN A LOT, AND THAT ALSO INCLUDES SOME RECOGNITION OF PEOPLE WHO HAVE WORKED LONG AND HARD FOR NIH AND WHO DO TEND ULTIMATELY TO DECIDE IT'S TIME TO MOVE ON TO OTHER THINGS OR TO RETIRE. SO I WANT TO RECOGNIZE A FEW OF THOSE FOLKS. NOW I CAN HAVE THE FIRST SLIDE. I WANT TO BEGIN WITH RICHARD NOK UMORA WHO HAS RETIRED AT THE END OF APRIL AS DIRECTOR OF THE CENTER FOR SCIENTIFIC REVIEW. RICHARD HAS A 39-YEAR CAREER AT NIH, STARTING AS A POST-DOC, THEN A BRANCH CHIEF, DEPUTY DIRECTOR, SCIENTIFIC DIRECTOR AT NIMH AND HE'S BEEN THE CSR DIRECTOR AND VERY ABLY LED THIS EFFORT. HE HAS CERTAINLY PROVIDED WISE COUNSEL TO ME AND MANY OTHERS OVER ALL THESE YEARS AND OF COURSE CSR IS A FUNDAMENTAL PART OF WHO WE ARE AND WHAT WE DO, OVERSEEING A GREAT MANY STRONG MAJORITY OF ALL THE PEER REVIEW THAT WE CARRY OUT. SO HE WILL BE MUCH MISSED. I JUST CHARGED THE SEARCH COMMITTEE YESTERDAY THAT WE HAVE SET UP TO LOOK FOR A NEW DIRECTOR OF CSR. IN THE MEAN TIERNLINGS I'M HAPPY TO SAY THAT NONI BURNS WHO IS SITTING RIGHT HERE, MAYBE STAND UP AND WAVE TO PEOPLE SO THEY CAN SEE YOU HAS AGREED TO SERVE AS ACTING CSR DIRECTOR AND IS DOING SO IN A VERY EFFECTIVE WAY HAD ANOTHER RETIREMENT TO NOTE, JIM BADDY, DIRECTOR OF THE NATIONAL INSTITUTE OF DEAFNESS AND OTHER COMMUNICATION DISORDERS AT NICD RETIRED JUNE 1-RBGS YOU CAN SEE HERE SOME PHOTOS FROM OUR FAREWELL RECEPTION ON MAY 21 INCLUDING SOME PHOTOS OF HIS FAMILY AND SOME SILLINESS THAT ALSO HAPPENED AS PART OF THIS. JIM ALSO WORKED IN MANY ROLES AT NCI, NINDS AND THEN NDNDC IN HIS TOTALS OF 35 YEARS INCLUDING 21 YEARS WHERE HE WAS PART OF THE COMMISSION CORPS, CONTRIBUTIONS INCLUDING THINGS SUCH AS COMMUNITY TOOLS FOR PROGRAMS SCREENING FOR NEWBORN HEARING. WHILE CONDUCTING A NATIONAL SEARCH FOR A NEW DREK TORQUES ALREADY UNDERWAY, JUDITH COOPER HAS AGREED TO SERVE AS ACTING DIRECTOR. JUDITH, MAYBE YOU COULD STAND UP AND WAVE. AGAIN, WE'RE FORTUNATE TO HAVE DR. COOPER SERVING VERY EFFECTIVELY IN THIS ROLE. ONE OTHER DEPARTURE TO NOTE, A REMARKABLE PERSON WHO SERVED AS THE CHIEF LEGAL ADVISOR, THE GENERAL COUNSEL TO NIH, BARBARA McGARY, HERE YOU SEE BEING SERENADED IN HER FAREWELL AND IN A PHOTOGRAPH THERE WITH HER HUSBAND, PATRICK AND MY WIFE DIANE. SHE HAS BEEN OUR CHIEF LEGAL ADVISOR FOR THE PAST 17 YEARS, ALTHOUGH TECHNICALLY SHE WORKS FOR HHS, CERTAINLY HER DEVOTION TO TRYING TO HELP NIH NEGOTIATE THROUGH MANY COMPLEX ISSUES IN TERMS OF LEGAL FACTORS HAS BEEN INCREDIBLY VALUABLE. SHE STARTED HERE AT NIH MANY YEARS AGO AS AN INTENSIVE CARE NURSE IN THE CLINICAL CENTER AND THEN STARTED GOING TO LAW SCHOOL AT NIGHT, SHE WORKED IN THE OFFICE OF TECH TRANSFER AT NIH AND WAS ONE OF MY POST TRUSTED ADVISORS, SO WE CERTAINLY ARE GOING TO MISS HER, BUT WE'RE FORTUNATE AGAIN TO HAVE WHILE THE SEARCH IS GOING ON FOR A REPLACEMENT AND THAT IS A SEARCH THAT HHS WILL DO, BUT DAVID ATLANTICFORD IS NOW ACTING -- DAVID LANKFORD IS NOW ACTING. SO THOSE ARE DEPARTURES OF PEOPLE WHO HAVE SERVED NOTICEABLY AND ABLY AND WE'LL MISS. WE ALSO HAVE SEARCHES GOING ON FOR PEOPLE THAT YOU HEARD ABOUT PREVIOUSLY DECIDING TO MOVE ON. FOR INSTANCE, AT N THRI IF AIB ROBERT PEDIGREW ACCEPTED A REMARKABLE OPPORTUNITY TO START A NEW MEDICAL SCHOOL IN HOUSTON, STARTING A REPLACEMENT FOR NIMIB , LIKEWISE FOR THE NATIONAL CENTER FOR COMPLEMENTARY EXPINT GRAYTIVE HEALTH WITH JOE ZI BRIGGS DECISION TO RETIRE AND TAKE ON THE JOB AS A JOURNAL EDITOR WE ARE ENGAGED IN A RESEARCH FOR A REPLACEMENT THERE HAPPY TO SAY BOTH OF THOSE SEARCHES HAVE GONE REALLY WELL AND WE HAVE REMARKABLY STRONG CANDIDATES ON THE SHORT LIST AND HOPE TO BE ABLE BY THE TIME WE GATHER IN DECEMBER TO TALK TO YOU ABOUT WHO WILL BE TAKING ON THOSE REINS AND MAYBE EVEN HAVE THEM PRETTY CLOSE TO ARRIVING. THEN WE'VE LAUNCHED A SEARCH FOR A NEW LEADERSHIP POSITION AT NIH CALLED THE CHIEF DATA STRATEGIST THIS NEW POSITION IS SOMEONE WHO WILL REPORT DIRECTLY TO ME AND WILL SERVE AS THE PRINCIPAL ADVISOR TO ME AND OTHER NIH LEADERSHIP IN THE BROAD DOMAIN OF LARGE SCALE PLALT FORMS AND TECHNOLOGIES AND TOOLS AND ECOSYSTEMS TO FACILITATE DATA SCIENCE. WE RECOGNIZE JUST HOW CRITICAL THIS FIELD IS TO OUR FUTURE. WE'VE HAD ADVICE FROM LOTS OF PEOPLE ABOUT HOW BEST TO ORGANIZE THAT AND BASICALLY SETTLED ON THE IDEA THAT WE NEED A LEADER IN THIS SPACE WHO HAS THAT KIND OF BIG DATA EXPERIENCE , AND I MUST SAY WE'RE PARTICULARLY INTERESTED IN FINDING THOSE WHO HAVE SPENT SOME TIME IN SILICON VALLEY, WE WANT TO KIND OF BRING THAT VERY EXPERIENCED PERSON TO THIS INSTITUTION. THAT WILL MEAN ENGAGING WITH EXCITING DATA INTENSE RESEARCH PROGRAMS SUCH AS ALL OF US, THE BRAIN INITIATIVE, THE CANCER MOONSHOT, AS WELL AS THE INTRA MURAL RESEARCH PROGRAM WHERE THERE'S A LOT OF DATA BEING PRODUCED AS WELL. THE GOAL BEING TO PROMOTE THE COORDINATION AND HARMONIZATION OF DATA, METHODS, TECHNOLOGIES, AND BEING SENSITIVE OF COURSE TO THE UNIQUE PROGRAMS AND GOALS OF THE INDIVIDUAL NIH INSTITUTES AND CENTERS. THE INCUMBENT RLSZ SHOULD POSITION NIH AS A CUTTING EDGE LEADER WITHIN THEFUL OF FIELD AND ENSURING NIH BENEFITS FROM AND CONTRIBUTES TO EFFECTIVELY USE OF PROPER USE OF RLSZ DISCOVERY, INNOVATION AND CARE AND COMMERCE. I WOULD ASK THE ACD TO KEEP YOUR EYES OPEN IF YOU HAVE IDEAS ABOUT THE RIGHT KIND OF PERSON WHO COULD FILL THIS CRITICAL ROLE, I HOPE YOU'LL SHARE THAT WITH LARRY, WITH ME, WE ARE VERY INTERESTED IN FINDING AN ABSOLUTELY SUPERB AND HIGHLY EXPERIENCED AND INNOVATIVE PERSON FOR THIS ROLE. AND FRANKLY, I THINK WE ARE MORE FOCUSED ON TRYING TO FIND SOMEONE WITH INDUSTRY AND SILICON VALLEY EXPERIENCE MAYBE THAN SOMEBODY WHO SPENT THEIR ENTIRE CAREER IN ACADEMIA, NOT THAT THERE'S ANYTHING WRONG WITH THAT, BUT FOR THIS PARTICULAR ROLE, THE KIND OF LEADERSHIP WE'RE LOOKING FOR MAY WELL BE THE KIND THAT DOESN'T NECESSARILY JUST HAPPEN IN A UNIVERSITY. SO THOSE ARE SOME OF OUR BOTH DEPARTURES AND HOPE FOR ARRIVALS , LET ME NOW TURN TO A FUEL OTHER NOTABLE EVENTS AT NIH SINCE WE MET, SPEAKING OF DATA SCIENCE, WE DID RELEASE JUST A COUPLE WEEKS APPEARING THE NIH STRATEGIC PLAN FOR DATA SCIENCE WHICH SEEKSZ TO CAPITALIZE ON THE OPPORTUNITIES I'VE BEEN MENTIONING TO MOVE FORWARD IN THIS AREA, DESCRIESHING NIH'S OVERARCHING GOALS, STRATEGIC OBJECTIVES, IMPLEMENTATION TACTICS, IF YOU HAVEN'T HAD A CHANCE TO LOOK AT THAT, I HOPE YOU WILL. IT IS A DOCUMENT THAT TOOK A LOT OF THOUGHT AND INPUT AND I THINK R I THINK WELL REPRESENTS WHERE WE WANT TO TAKE THE ENTERPRISE, INCLUDING STANDARDS THAT WE WANT TO ADHEEF -- TO ACHIEVE IN TERMS OF FAIR PRINCIPLES, INTEGRATION OF EXISTING TOOLS AND DEVELOPMENT OF NEW ONES, AND HOW TO HANDLE THE GROWING COSTS OF DATA MANAGEMENT. AND MUCH THANKS TO THE GROUP THAT HAS PUT THAT TOGETHER, PARTICULARLY JORN LORSCH AND STEVE CATS WHO OVERSEE THE THIS DOCUMENT ALONG WITH OTHER COLLEAGUES. THAT'S A BIG DEAL. ANOTHER BIG DEAL HAS BEEN THE LAUNCH OF A PROJECT WHICH WAS PRETTY MUCH SHAPED BY THE ACD, AND THAT IS THE PRECISION MEDICINE INITIATIVE. YOU WILL NO DOUBT REMEMBER SOME OF YOU AT LEAST THE HISTORY OF THIS, THAT THIS WAS AN IDEA WHICH WAS PUT FORWARD INITIALLY IN THE STATE OF THE UNION ADDRESS BY PRESIDENT OBAMA AND THEN NIH WAS GIVEN THE CHARGE TO ACTUALLY DESIGN THIS AND A WORKING GROUP OF THE ACD SPENT A VERY INTENSE YEAR COMING UP WITH THE OVERALL PLAN AND THEN WE PUT IN PLACE A TEAM TO BEGIN TO TRY TO PRODUCE THE NECESSARY OUTPUTS THERE'S BEEN BROAD ENTHUSIASM ABOUT THIS PROJECT ALL ALONG FROM BOTH THE ADMINISTRATION AND THE CONGRESS. THE CONGRESS INCLUDED FUNDING FOR ALL OF US IN THE 21ST CENTURY CURES BILL, WHICH MEANS IT HAS A FUNDING TRAJECTORY THAT STRETCHES OUT OVER 10 YEARS AS WELL AS SOME ADDITIONAL FUNDING IN THE BASE THAT WE GET EACH YEAR IN APPROPRIATIONS. ERIC DISHMAN WAS HIRED FROM INTEL TO COME AND BE THE DIRECTOR AND HAS BRAWRT WITH HIM ENORMOUS -- BROUGHT WITH HIM ENORMOUS AMOUNT OF ENERGY AND ENTHUSIASM AND EXPERIENCE IN THE MANAGEMENT OF LARGE COMPLICATED PROJECTS AS WELL AS HIS OWN PASSION FOR THIS GIVEN HIS OWN PERSONAL HISTORY OF KIDNEY CANCER AND HOW PRECISION MEDICINE APPROACH HE WOULD CREDIT FOR THE FACT THAT HE'S STILL ALIVE. HE HAS BEEN A WONDERFUL BREATH OF INTENSE FRESH AIR TO THIS PLACE AS HE'S ARRIVED TO MANAGE THIS. KNOWING THAT THIS WAS GOING TO BE A REALLY COMPLICATED PROJECT TO TRY TO AFTER ALL ENROLL A MILLION AMERICANS IN A DISPL FOLLOW-UP STUDY, TCHES DECIDED THAT WE NEEDED TO ENLIST HEALTH PROVIDER ORGANIZATIONS AS PART OF THE EFFORT BUT ALSO TO MAKE IT POSSIBLE FOR DIRECT VOLUNTEERS ANYWHERE IN THE COUNTRY TO SIGN UP, THAT WAS THE RECOMMENDATION OF THAT ACD WORKING GROUP, TO TEST OUT ALL THE PARTS OF THIS, INCLUDING THE DATA CENTER WHICH INVOLVES BOTH VERILY AND VANDERBILT AND THE BIOSPECIMEN REPOSITORY WHICH IS AT MAYO, A BETA TEST OF THIS BEGAN JUST ABOUT A YEAR AGO BRINGING ON BOARD BIT BY BIT THE VARIOUS PIECES OF THIS TO SEE HOW THEY WOULD FUNCTION. WE HAVE LEARNED A TREMENDOUS AMOUNT ABOUT THAT PROJECT ALONG THE WAY AND JUST THE BETA TEST WAS ABLE TO ENROLL 27,000 PEOPLE MAKING IT ONE OF THE LARGER STUDIES THAT NIH HAS MOUNTED, AND THAT WAS JUST THE PILOT. BUILDING ON ALL OF THAT AND WITH CONFIDENCE THAT THE DATASETS WERE OF THE KIND THAT WE NEEDED IN TERMS OF THE QUALITY OF THE DATA AND ALSO THE SECURITY OF THE DATA WE NEEDED BASED ON HACK ATHONS WITH WHITE HATLE AND OTHER MEASURES, WE DECIDED IT WAS TIME TO LAUNCH, AND ON MAY 6 IN A ARE EXTRAVAGANZA ON A SUNDAY AFTERNOON ACROSS THE COUNTRY IN 7 DIFFERENT LOCATIONS ALLOFUS IN FACT GOT UNDERWAY IN A FASHION THAT YOU MIGHT HAVE SEEN SOMETHING ABOUT, MAIL 6, 2018, I'M JUST GOING TO PLAY YOU THE ONE MINUTE VIDEO THAT WAS MADE TO SORT OF CAPTURE A FEW OF THE THINGS THAT HAPPENED ON THAT DAY IN THE 7 DIFFERENT LOCATIONS I WAS AT THE ABISINIAN BAPTIST CHURCH IN HARLEM, ONE OF THE SITES IN NEW YORK, IT WAS INSPIRING TO BE IN THE MIDDLE OF ALL THIS AND TO SEE THE EMBRACE, RF WIEFDLY DIVERSE COMMUNITIES AND THE IMPORTANCE OF TAKING PART IN THIS. [MUSIC] * ARE * >> Francis Collins, MD: AND IF YOU HAVEN'T ALREADY SIGNED UP, JOIN ALL OF US.ORG IS ALL YOU NEED TO KNOW, THE SIGN-UP PROCESS WILL TAKE YOU ABOUT HALF AN HOUR. DEPENDING ON WHERE YOU ARE, THE ABILITY TO THEN GET THE BLOOD SAMPLE AND THE PHYSICAL MEASUREMENTS MIGHT HAPPEN READILY IF YOU'RE CLOSE TO ONE OF THE HEALTH PROVIDER ORGANIZATIONS OR IT MAY BE SOMETHING WE'LL BE SCHEDULING IN THE COMING MONTHS ACROSS THE NATION, TAKING ADVANTAGE OF PARTNERS SUCH AS WALGREENS TO MAKE IT POSSIBLE TO BE CLOSE TO MOST PEOPLE. SO THIS IS UNDERWAY. WE HAD A WONDERFUL RESULT THE VERY FIRST WEEK OF A VERY BIG BUMP IN SIGNUPS AND THAT MOMENTUM SEEMS TO BE CONTINUING, AND OBVIOUSLY THAT NEEDS TO IF WE'RE GOING TO GET TO A MILLION, THAT'S A BIG NUMBER. AND WE WANT TO MOVE AS FAST AS WE CAN IN THAT. IF YOU DIDN'T SEE ERIC DISHMAN'S IT OP-ED IN THE STAT JOURNAL YESTERDAY, THAT WOULD BE A GOOD PLACE TO LOOK FOR A NICE SUMMARY OF WHY WE'RE DOING THIS AND WHAT IT IS ALL ABOUT AND WHY PEOPLE MIGHT WANT TO CONSIDER SIGNING UP. AND I MIGHT SAY THAT ONE OF THE THINGS THAT WE'RE PARTICULARLY EXCITED ABOUT HAD IS THE OPPORTUNITY TO DO SOME INTERNATIONAL COLLABORATIONS WITH OTHER PROJECTS LIKE THIS AND OF COURSE PARTICULARLY WE THINK THE UK BIOBANK WHICH HAS BEEN UNDERWAY NOW FOR SEVERAL YEARS, BUT MANY OTHER PROJECTS. IN THAT REGARD I WAS DELIGHTED THAT JEFF GINSBURG AND TERRY MOL ONIO THROUGH THE PROGRAM G2C HOSTED A COHORT SUMMIT IN MARP AT DUKE AND BROUGHT TOGETHER THE PRINCIPAL INVESTIGATORS OF A VERY LARGE NUMBER OF THESE STUDIES THAT HAVE PLANNED TO ENROLL OR ALREADY ENROLLED AT LEAST 100,000 PEOPLE AND TRY TO WORK THROUGH SOME IDEAS ABOUT HOW TO HAVE SOME SHARING PLAN ARE, SOME DATA STANDARDS SO THAT SHARING COULD MAKE SENSE, WE COULD DO META-ANALYSES, THRCHES A LOT OF THERE ENTHUSIASTIC AND EXCITEMENT, JEFF, I'LL CALL YOU ON IF YOU WANT TO COMMENT ABOUT HOW THAT MEETING WENT AND WHAT WE MIGHT DO NEXT TO TRY TO BUILD ON THAT. >> FRANKS, FRANCIS, THANK YOU FOR -- THANKS, FRANCIS, THANK YOU FOR FIRST INITIATING THIS OVER A YEAR AGO THROUGH THE HOE ROW ORGANIZATION R AT THE TIME YOU WERE CO-CHAIRING, IT WAS A YEAR AGO AT THIS MEETING THAT WE BEGAN TO TALK ABOUT PUTTING THIS SUMMIT TOGETHER AND WE WERE QUITE DELIGHTED THAT FIRST OF ALL WE WERE ABLE TO IDENTIFY OVER 60 COHORTS AROUND THE WORLD THAT HAD OVER 100,000 INDIVIDUALS TARGETED OR CURRENTLY UNDER THEIR ENROLLMENT WITH BIOLOGICAL SPECIMENS, LONGITUDINAL FOLLOW-UP AND THAT WAS WHAT WAS REPRESENTED AT THIS MEETING THROUGH A SURVEY WE IDENTIFIED THAT WE HAD OVER 25 MILLION PARTICIPANTS REPRESENTED IN THE ROOM THROUGH THESE COHORTS AND I THINK THE ENGAGEMENT OF THE PI'S OF THESE GROUPS TOO, I THINK ABOUT COLLABORATIVE WORK, DATA SHARING AND HARMONIZATION OF THESE EFFORTS TO REALLY CATAPULT SCIENCE AS WELL AS POTENTIALLY CLINICAL APPLICATIONS WAS TREMENDOUS. SO LAST WEEK OR THE WEEK BEFORE, THE SUMMARY OF THIS MEETING WAS PRESENTED TO THE HEADS OF INTERNATIONAL RESEARCH ORGANIZATIONS AND I THINK ROGER GLASS WAS THERE, ERIC GREEN MADE THE PRESENTATION, AND I THINK THE FEEDBACK WAS UNIFORMALLY POSITIVE THAT THIS WAS A GREAT START AND THAT WE NEEDED TO NOW COME UP WITH A PLAN TO MOVE THE INITIATIVE FORWARD TO REALLY ACHIEVE THE GOALS THAT ARE ARTICULATED ON THIS SLIDE. SO WE'RE WORKING TOWARDS THAT. THANK YOU. >> Francis Collins, MD: WELL, THANKS TO YOU AND TO THE G2MC FOR AGREEING TO TAKE ON THE HOST ING OF THAT MEETING AND WHAT WE NEED TO DO NEXT. SO I THINK -- LET ME SEE WHAT THE NEXT SLIDE IS. YEAH. SOMETHING SLIPPED IN MY NOTES. ANYWAY, I WANTED TO TELL BU SOME OTHER THINGS THAT HAVE HAPPENED IN THE COURSE OF THE LAST SIX MONTHS, BEGINNING WITH SCIENCE ADVANCES. THERE HAVE BEEN SO MANY DEVELOPMENTS OVER THESE SIX MONTHS, THAT THIS ONLY CAPTURES A FEW OF THE HEADLINES THAT ARE REPRESENTED BY VARIOUS PRESS RELEASES WE HAVE PUT OUT. I HOPE ALL OF YOU ARE HAVING THE OPPORTUNITY NOW AND THEN TO LOOK AT THE BLOG I WRITE EVERY TUESDAY AND EVERY THURSDAY, MOST OF THOSE BLOGS ARE ABOUT SCIENCE ADVANCES THAT HAVE HAPPENED, SO IF YOU JUST GO TO THE NIH WEBSITE, GO TO THE NIH DIRECTOR AND LOOK FOR THE BLOG, YOU CAN SIGN UP, THOSE BLOGS NOW ARE REACHING TENS OF THOUSANDS OF PEOPLE, IT'S QUITE A WIDE VARIETY OF FOLKS. I TRY TO WRITE THESE SO THAT THEY'RE ACCESSIBLE TO SOMEBODY WHO IS INTERESTED IN SCIENCE BUT NOT NECESSARILY HIEM SOPHISTICATED ABOUT IT. AND IT'S NO PROBLEM FINDING THINGS TO WRITE B IT'S ALWAYS A CHALLENGE TO FIGURE OUT WHICH THING TO PICK BECAUSE THERE'S USUALLY SEVERAL THINGS EACH WEEK THAT I WOULD THINK WOULD BE FUN TO TALK ABOUT. ON THURSDAYS I OFTEN WRITE ABOUT A PARTICULAR SCIENTIST WHO IS DOING AN INNOVATIVE KIND OF PROJECT AND TRY TO PROFILE THAT SCIENTIST OR ELSE SOMETIMES WE PICK INTERESTING VISUAL IMAGES BECAUSE BIOLOGY PRODUCES A LOT OF THOSE AND PUT THOSE OUT THERE FOR PEOPLE TO LOOK AT. SO YEAH, LOTS OF AMAZING SCIENCE HAPPENING. WE ALSO HAVE HAD A LOT OF VISITORS, SO I WANTED TO TALK TO YOU ABOUT THE VISITS WE'VE HAD, EXECUTIVE BRANCH AND THE LEGISLATIVE BRANCH. WE HAVEN'T HAD ANY FROM THE SUPREME COURT BUT WE'RE LOOKING FORWARD TO THAT. ADMINISTRATION, WE HAD A LOVELY VISIT ON VALENTINE'S DAY FROM THE FIRST LADY OF THE UNITED STATES WHO CAME TO VISIT WITH CHILDREN WHO ARE STAYING THERE. THEY ARE KIDS WHO ARE IN CLINICAL TRIALS AT THE CLINICAL CENTER, AND THEY SPEND THEIR EVENINGS ALONG WITH THEIR FAMILIES AT THE CHILDREN'S INN, THOSE OF YOU ON THE ACD WHO WERE HERE LAST DECEMBER KNOW THAT WE HAD DINNER THERE AT THE CHILDREN 'S INN AND YOU HAD A CHANCE FOR A TOUR, ALWAYS AN INCREDIBLY INSPIRING PLACE. AND MELANIA TRUMP ON HER OWN TO COME AND VISIT THE CHILDREN'S INN AND JENNY LUCA WHO IS SITTING OVER HERE, THE CHIEF EXECUTIVE OFFICER OF THE CHILDREN'S INN ARRANGED A REALLY WONDERFUL AFTERNOON AND MRS. TRUMP I THINK WAS VERY AFFECTED BY WHAT SHE SAW SAW, SPOKE WARMLY ABOUT IT IN TIMES THAT I'VE SEEN HER SINCE THEN AS HAVING BEEN A REALLY SPECIAL DAY SHE WAS INCREDIBLY GRACIOUS AND AT EASE WITH THE KIDS IN THIS SETTING AND OF COURSE IT WAS VALENTINE'S DAY SO THERE WERE COOKIES BEING DECORATED AND CARDS BEING MADE AND SHE WAS TOTALLY AT HOME WITH ALL OF THAT WE'VE HAD OUR NEW SECRETARIAL LEKS SAZAR OUT TO VISIT AND FOUND HIM TO BE A REMARKABLE PERSON TO WORK WITH AND ALLY IN MANY THINGS, HERE YOU SEE HIM WITH STEVE ROSENBERG EXPLAINING A PARTICULAR CASE OF CANCER IMMUNOTHERAPY AND OF COURSE WE HAD TO GIVE HIM SOMETHING TO CO- NOTE THE SOMETIME HE GOT SCRUBS WITH HIS NAME ON IT, SINCE WE ARE BOTH A RESEARCH ORGANIZATION AND WE RUN A HOSPITAL. I'VE HAD THE PRIVILEGE ALONG WITH LARRY OF MEETING WITH SECRETARY ACZAR EVERY TWO WEEKS FOR A GOOD SOLID HOUR, I ALWAYS BRING TO THOSE MEETING SOME EXCITING SCIENCE TO START IT OFF WITH, WHICH HE ALWAYS APPRECIATES, ASKS GREAT QUESTIONS, HIS COMBINATION OF EXPERIENCE IN GOVERNMENT BECAUSE HE WAS IN THE GEORGE W. BUSH ADMINISTRATION AS GENERAL COUNSEL AND THEN AS DEPUTY SECRETARY, HE KNOWS HOW GOVERNMENT WORKS BUT HE SPENT NINE YEARS AT LILY SO HE ALSO KNOWS HOW IT IS THAT YOU MAKE DRUGS AND HOW YOU FEED SCIENCE INTO ULTIMATE PUBLIC BENEFIT, SO HE'S BROUGHT A LOT OF SKILL AND EXPERTISE AND HAS BEEN REALLY QUITE REMARKABLE PERSON FOR US TO WORK WITH. ALSO REMARKABLE ARRIVING ON THE SCENE, OUR SURGEON GENERAL, JEROME ADAMS COMING TO US FROM HIS PREVIOUS ROLE AS THE PUBLIC HEALTH COMMISSIONER IN INDIANA, BUT A PROUD ALUMNUS OF UMBC, FREEMAN HERBOWSKI'S PROGRAM, JEROME HAS BEEN A REMARKABLE VISIONARY ARTICULATOR OF THE NEEDS FOR BETTER PUBLIC HEALTH ACROSS A NUMBER OF AREAS AND OF COURSE RIGHT NOW MUCH OF THAT FOCUSED ON OPIOIDS. HE'S BEEN OUT TO VISIT US ALMOST FROM THE FIRST DAY THAT HE ARRIVED AND THEN AGAIN CAME OUT IN MAY FOR A FIRESIDE CHAT WITH ME AS PART OF OUR PAIN INITIATIVE RESEARCH PROGRAM AND HAS BEEN A WONDERFUL ALLY IN MANY THINGS AND JUST A REMARKABLE HUMAN BEING. AND ALSO IN THE DEPARTMENT L ADMIRAL BRETT GIRAR, A PEDIATRIC INTENSIFIST IN TRAINING RUNNING A PEDIATRIC IN THE PAST, ASSISTANT SECRETARY FOR HEALTH, HAS COME TO US TO VISIT AND LEARN ABOUT WHAT'S HAPPENING IN THE VACCINE RESEARCH CENTER, WHICH IS WHAT'S BEING DESCRIBED HERE, HE'S TAKEN IT ON TO BE THE COORDINATOR ACROSS THE DEPARTMENT OF EVERYTHING WE'RE DOING WITH OPIOIDS AND PAIN AND HAS BEEN REMARKABLY EFFECTIVE IN THAT WAY TO BE SURE THAT NIH AND CDC AND FDA AND SAMHSA AND HRSA AND ARC AND CMS AND ALL THE OTHER COMPONENTS THAT HAVE EQUITIES HERE HAVE A CHANCE TO DO SO IN THE MOST EFFICIENT FASHION AND WE ARE REALLY HAPPY TO HAVE HIM IN THAT LEADERSHIP ROLE AND YOU'LL PROBABLY HEAR MORE ABOUT THAT TOMORROW WHEN WE TALK ABOUT OPIOIDS. JUST TWO DAYS APPEARING THE NEW CDC DIRECTOR BOB REDFIELD CAME FOR AN AFTERNOON, I GUESS THREE DAYS AGO, JUNE 11, MET WITH TONY AND MYSELF AND YOU'LL ALSO SEAL HERE JIM GILMAN WHO IS THE CEO OF THE CLINICAL CENTER, BOB GOT A TOUR THROUGH THE VACCINE RESEARCH CENTER BY TONY AND HIS COLLEAGUES, PARTICULAR INTEREST OF COURSE ON WHAT'S HAPPENING WITH THE EFFORT TO DEVELOP AN INFLUENZA VACCINE, TONY ALSO TOOK HIM UP TO SEE THE SPECIAL CLINICAL STUDIES UNIT, OUR UNIT THAT IS DESIGNED IF NECESSARY TO HANDLE PATIENTS WITH HIGHLY INFECTIOUS DISEASES SUCH AS EBOLA, THAT SAME UNIT WHERE WE TOOK CARE PREVIOUSLY, PATIENTS WITH EBOLA, TONY WAS PERSONALLY INVOLVED IN CARING FOR, AND IF WE NEED TO USE IT AGAIN, IT'S READY TO GO. IN TERMS OF THE CONGRESS, WE'VE ALSO HAD OPPORTUNITIES TO INVITE FOLKS OUT HERE AND WE LOVE IT WHEN THEY COME TO SEE US BECAUSE WE CAN SHOW THEM SOME OF THE THINGS HAPPENING IN BASIC SCIENCE ALL THE WAY TO CLINICAL APPLICATIONS. SENATOR ROY BLUNT OF MISSOURI, CHAIR OF THE SENATE APPROPRIATIONS SUBCOMMITTEE WANTED TO SEE WHAT WAS GOING ON AT NCATS SO THIS IS A PHOTOGRAPH WITH CHRIS AUSTIN OUT THERE AT THE NCATS FACILITY STANDING IN FRONT. ROBOT CAPABLE OF DOING HIGH THROUGHPUT SCREENING AND SENATOR BLUNT HAD LOTS OF GREAT QUESTIONS AND I THINK WAS VERY IMPRESSED WITH THE KINDS OF TECHNOLOGIES THAT EXIST IN THAT NCATS FACILITY, WHICH ARE REALLY QUITE BREATHTAKING. SENATOR MAGGIE HASSUN FROM NEW HAMPSHIRE CAME TO VISIT WITH A GREAT DEAL OF INTEREST IN A NUMBER OF THINGS, INCLUDING ALZHEIMER'S DISEASE, INCLUDING OPIOIDS, HERE SHE'S GETTING A DEMONSTRATION ABOUT SOME RESEARCH BEING DONE IN THE EYE INSTITUTE. REPRESENTATIVE LEONARD LANCE CAME AS PART OF RARE DISEASE DAY, HE'S THE COAL CHAIR OF THE RARE DISEASE CAUCUS IN THE CONGRESS AND SPENT SOME TIME WITH US AND GAVE SOME NICE REMARKS AS PART OF A SPECIAL EVENT WE HAD ON THAT DAY CELEBRATING ADVANCES IN RARE DISEASE WITH MANY ADVOCATES PRESENT TO TALK ABOUT WHAT THEIR HOPES ARE FOR WHERE THIS CAN ALL GO. REPRESENTATIVE JAMIE RASKIN, WHO IS THE CONGRESSMAN FROM MONTGOMERY COUNTY MARYLAND, HE'S THE DISTRICT IN WHOM NIH EXISTS, CAME TO SEE US, FIRST TERM CONGRESSMAN, WE GAVE HIM AN OVER VIEW OF WHAT NIH IS ALL ABOUT AND HE WAS QUITE ENTHUSIASTIC ABOUT THAT. SENATOR JACK REED FROM RHODE ISLAND WITH A PARTICULAR INTEREST IN PEDIATRIC CANCER CAME AND VISITED WITH THE PATIENTS IN THE CLINICAL CENTER AS YOU CAN SEE THERE AND THEN HAD SOME PRETTY INTERESTING CULGT EDGE SCIENCE EXPLAINED -- CUTTING EDGE SCIENCE EXPLAINED TO HIM BY NED SHARPLESS AND COLLEAGUES. NCI. IN ADDITION TO POLITICAL FIGURES , WE'VE HAD SOME OTHER SPECIAL EVENTS AND IT'S ALWAYS FUN TO TELL YOU WHAT THESE ARE. WE DO HAVE THE OPPORTUNITY BECAUSE OF BEING A LARGE COMPLICATED INSTITUTION LOCATED IN A PLACE WHERE A LOT OF PEOPLE ARE INTERESTED IN COMING TO INVITE SPECIAL FOLKS TO TURN UP. SO JIM KIM WAS HERE, OUR PRESIDENT OF THE WORLD BANK, FOR A SHOWING OF THE FILM THAT IS ABOUT PARTNERS IN HEALTH AND THE WORK THAT THEY DID IN HAITI AND IN PERU AND IN RWANDA AND THEN JIM AND I HAD A CONVERSATION ABOUT WHERE WE'RE GOING WITH GLOBAL HEALTH IN FRONT OF A PACKED AUDIENCE ON MARCH 12 AND I GOT A LOT OF -- AND IT GOT A LOT OF PEOPLE I THINK PRETTY FIRED UP ABOUT WHERE THIS COULD ALL GO. HE'S SOMEBODY WHO IS A PHYSICIAN HEAD OF THE WORLD BARK, REMARKABLE CIRCUMSTANCE, PREVIOUS PRESIDENT OF DARTMOUTH AND WITH A GREAT ASP PITCHES VISION ABOUT HOW TO MAKE THE WORLD A BETTER PLACES AND PARTICULARLY HOW TO DEAL WITH THOSE MOST DIFFICULT AREAS OF EXTREME POVERTY AND ILL HEALTH AND HE'S BEEN A GREAT ALLY. THE NEW DIRECTOR GENERAL. WORLD HEALTH ORGANIZATION -- NEW DIRECTOR OF THE GENERAL OF THE WORLD HEALTH ORGANIZATION, TEDRO S, HE'S FINE WITH BEING CALLED DR. TEDROS, HE INVITED BY ROGER AND TONY AND MYSELF CAME ON APRIL 20 FOR A MEETING WITH SOME OF THE INSTITUTE DIRECTORS AND THEN THE SIGNING OF AN MOU ABOUT INFECTIOUS DISEASES, WHICH YOU CAN SEE HE AND TONY PUTTING DOWN THEIR SIGNATURES RIGHT THERE IN THE STONE HOUSE HERE ON THE CAMPUS T THEN CARRIE AND JOHN BURKLOW AND I WERE INVITED TO COME TO THE FOURTH ANNUAL VATICAN CONFERENCE, THIS IS ACTUALLY IN ROME, THIS IS A CONFERENCE THAT'S BEEN HELD EVERY TWO YEARS AS AN OPPORTUNITY FOR THE CATHOLIC CHURCH TO HEAR FROM SCIENTISTS ABOUT WHAT IS HAPPENING IN ADVANCES AND THIS FOCUS WAS PARTICULARLY ON CELL THERAPY AND GENE THERAPY AND GENE EDITING WAS HEAVILY FEATURED AS WELL, A MIX OF PEOPLE IN ACADEMIA, IN THE PRIVATE SECTOR, ADVOCATES, WITH A LOT OF SENIOR LEADERSHIP OF THE CATHOLIC CHURCH PRESENT SOAKING UP WHAT THE POSSIBILITIES ARE HERE, INCLUDING A PRIVATE SESSION THAT WE HAD AT THE PONTIFICAL ACADEMY , AND LOTS OF INTERESTING CONNECTIONS THERE, AND WE WERE ALSO GIVEN AN OPPORTUNITY TO HEAR FROM POPE FRANCIS IN A CLOSED SESSION WHERE HE SPOKE ABOUT HIS OWN HOPES ABOUT HOW SCIENCE CAN BRING ANSWER TO CASES OF HUMAN SUFFERING. AND I WAS HONORED BY THIS PONTIF ICAL KEY SCIENTIFIC AWARD, AS YOU CAN SEE IN THAT PHOTO, SURROUNDED BY CARDINALS, SOMETHING I DON'T THINK HAS HAPPENED TO ME BEFORE, AGAIN, A VERY MEMORABLE OCCASION. AND THEN AS OUR CULTURAL LECTURE OF THE YEAR, WE HAD NONE OTHER THAN BARBARA STREISAND HERE ON MAY 18. SHE IS BOTH OF COURSE ONE OF THE BEST KNOWN SINGERS, SONGWRITERS, FILM PRODUCERS AND ACTRESSES IN THE WORLD, BUT ALSO CO-FOUNDER OF THE WOMEN'S HEART ALLIANCE FOCUSED PARTICULARLY ON WHAT SHE AND MANY OTHERS HAVE ARGUED IS A NEED FOR MORE ATTENTION TO HEART DISEASE IN WOMEN, THAT IT IS IN SOME WAYS DIFFERENT THAN HEART DISEASE IN MEN AND HAS NOT GOTTEN NEARLY THE SAME ATTENTION SHE GAVE A STIRRING SPEECH AND THEN SAT DOWN WITH ME FOR A CONVERSATION ABOUT WHERE THIS MIGHT ALL GO, AND WE THEN GAVE HER A TOUR OF SOME PARTS OF THE CLINICAL CENTER. SHE MET PATIENTS WHO ARE INVOLVED IN CURRENT TRIALS ABOUT THE CONNECTION BETWEEN HIV AND HEART DISEASE IN WOMEN AND WHAT WE MIGHT BE ABLE TO DO ABOUT THAT IN TERMS OF INTERVENTIONS. AND SHE ALSO BROUGHT ALONG ANOTHER PERSON WHO HAPPENS TO BE HER HUSBAND, JIM BROLAND, WHO WAS ALSO DELIGHTFUL TO INTERACT WITH. ANYBODY WHO IS OLD ENOUGH LIKE ME TO REMEMBER MARCUS WELBY, MD, WELL, THCHES THE YOUNGER DOCTOR WITH THE MOTORCYCLE WHO WAS REALLY COOL. HE SAYS HE DOESN'T RIDE MOTORCYCLES ANYMORE BUT HE HAS A REALLY GOOD PICKUP. A LOVELY GUY. BUT HAVING THE OPPORTUNITY TO WORK WITH BARBARA IN THIS SETTING AND TO SPREAD THE WORD ABOUT THE IMPORTANCE OF FOCUS ON WOMEN'S HELTD WAS REALLY QUITE MEMORABLE -- WOMEN'S HEALTH WAS REALLY QUITE MEMORABLE. WE'RE FORTUNATE EVERY YEAR TO BE ABLE TO INVITE SOMEBODY OF REMARKABLE STATURE AS A CULTURAL RRLSZ LECTURE, LAST YEAR IT WAS YOYO MA, NOT LONG AGO IT WAS THE DALAI LAMA, THAT IS A GREAT THING TO PUT IN FRONT OF THE 23,000 PEEMENT THAT WORK HERE AND HAVE A CHANCE TO HEAR FROM PEOPLE OF THAT CALIBER TO HEAR ABOUT HOW THEY CARE ABOUT WHAT'S GOING ON IN MEDICAL RESEARCH. THEN JUST A WEEK AGO WE ALSO HAVE AN ANNUAL EVENT, THIS IS ONLY THE SECOND TIME WE'VE DONE IT, CALLED THE BIG READ WHERE A BOOK IS CHOSEN THAT IS OF INTEREST BECAUSE IT'S RELATED TO SOME MEDICAL THEME. LAST YEAR IT WAS IT SEDARKI MUTH IGI TALKING ABOUT HIS BOOK ON THE GENE CVMENTD THIS YEAR, FIRST BOOK CALLED I CONTAIN MULTITUDES, ABOUT THE MICROBIOME, THAT BOOK IS FASCINATING THE NUMBER OF EXAMPLES HE COMES UP WITH NOT JUST IN HUMAN HEALTH BUT ACROSS PRETTY MUCH ALL ACROSS BIOLOGY AND ZOOLOGY, SO WE HAD A CHAT AGAIN WITH QUESTIONS SUPPLIED BY THE AUDIENCE FOR HIM TO DISCUSS WHAT MADE HIM DECIDE TO WRITE ABOUT THIS AND WHAT ARE SOME OF THE THINGS THAT HE WOULD WANT EVERYBODY TO KNOW H BY ED YONG. AND FINALLY JUST FOR THE FUN OF IT, JUST THIS PAST TUESDAY R WHERE THERE IS A WONDERFUL TUESDAY CAMP FANTASTIC WHICH THE NCI HAS BEEN RUNNING FOR MANY YEARS, WHICH IS A CAMP FOR KIDS WITH CANCERRING IT'S HELD HERE IN FRONT ROYAL FOR A WEEK, ALL THE KIDS WHO COME THERE ARE EITHER SURVIVORS OR CURRENTLY BATTLING CHILDHOOD CANCERS, MANY OF THEM ACTUALLY CAN YOU REMEMBER UNDERGOING THERAPY, STEVE CHANEK WHO RUNS THIS ENTERPRISE HAS TO SET UP EFFECTIVELY ALMOST AN ICU IN CASE SOMEBODY GETS SICK BUT LOTS OF THE KIDS THERE ARE GETTING DAILY INFUSIONS AND IT IS SUCH A GIFT TO THEM BECAUSE THEY'RE ABLE FOR THAT WEEK TO BE KIDS WHO WENT TO CAMP AND TO BE THERE WITH OTHER KIDS LIKE THEM WHO HAVE BEEN GOING THROUGH THIS. SO THERE WAS A BARBECUE TO BASICALLY DRAW ATTENTION TO CAMP FANTASTIC AND THEY INVITED THE BAND, WHICH I HAVE THE PRIVILEGE OF BEING PART OF. WE ARE THE AFFORDABLE ROCK & WE'RE SO AFARDABLE WE'RE FREE BECAUSE WE'RE ALL GOVERNMENT EMPLOYEES SO WE HAVE TO BE FREE. EVERYBODY YOU SEE THERE IS A SCIENTIST IN ONE PART OF THE NIH OR ANOTHER, INCLUDING EVERYTHING FROM POST BACKS POST BACCS LIKE OUR LEAD SINGER STANDING NEXT TO ME, INCLUDING TO PEOPLE LIKE JOHN OH SHAI, A SCIENTIFIC DIRECTOR OF R, AND EVERYTHING IN BETWEEN. WE MAY NOT BE THAT IF IT GREAT BUT WE SURE HAVE A GOOD TIME. WE MANAGED A TWO HOUR IT SESSION WITHOUT REPEATING ANY SONGS AND ROCKED THE HOUSES. THAT'S THE KIND OF THING THAT YOU CAN DO IN THIS PLACE NOW AND THEN JUST BECAUSE PEOPLE ARE ENTHUSIASTIC AND THEY HAVE DIVERSE ASPECTS TO WHO THEY ARE AND NOT JUST THE SCIENCE THEY DO WHO SAID SCIENTISTS DON'T KNOW HOW TO ROCK? THOSE ARE THE THINGS I WANTED TO TELL BU IN TERMS OF THINGS HAPPENING AROUND HERE, VISITS AND OTHER THINGS. I THINK I'LL AT THIS POINT TURN THIS TO TONY FAUCCI AND ASK HIM TO TALK TO YOU ABOUT WHERE WE ARE WITH EBOLA AND TONY MAYBE YOUR SLIDES CAN BE PULLED UP. TONY, THANK YOU FOR TAKING TIME OUT OF A VERY BUSY THURSDAY, I'M SURE, TO COME AND ADDRESS THE AC D. >> THANK YOU VERY MUCH, FRANCIS, FOR GIVING ME THIS OPPORTUNITY TO BRING YOU ALL UP TO DATE ON THE ISSUE OF EBOLA. FRANCIS ASKED ME TO DO THIS ABOUT A DAY AGO. >> Francis Collins, MD: YEAH, YEAH. >> I'VE ENTITLED THIS EBOLA THEN AND NOW, AND I WANT TO MAKE JUST TWO POINTS TO LEAVE YOU WITH, WITH THIS PRESENTATION. ONE IS HOW ONE CAN LEARN FROM A PREVIOUS EXPERIENCE OF AN OUT BREAK AND APPLY IT TO A SUBSEQUENT OUTBREAK OF SIMILAR TYPE, BUT ALSO I THINK AS MORE IMPORTANTLY THE ROLE OF THE NIH IN DOING SOMETHING THAT YOU DON'T USUALLY THINK THEY TORQUES NAME AM IN THE ARENA OF RO1'S AND PO1'S AND CONTRACTS BUT HOW WE AS AN ORGANIZATION CAN ESSENTIALLY HIT THE GROUND RUNNING WHEN CALLED UPON IN AN EMERGENCY SITUATION. SO THE ISSUE IS EBOLA, THIS IS A TYPICAL EM THAT WE ALL USE. I SHOW IT BECAUSE IT JUST SORT OF REFLECTS THE SERIOUSNESS OF THE DISEASE ITSELF. THIS IS A TERRIBLE DISEASE AND A VERY UGLY-LOOKING VIRUS, AS YOU CAN SEE HERE. JUST VERY, VERY QUICKLY, I'M SURE MOST IF NOT ALL OF YOU ARE FAMILIAR, BUT THE EBOLA IS A MEMBER. FAMILY FILA VIRUS, THERE ARE MULTIPLE SUBGROUPS, THE ONE WE'VE BEEN DEALING WITH IS THE Z IEA EBOLA VIRUS, ABOUT 40 PERCENT OF AWFL THE ISOLETTES THAT HAVE OCCURRED SINCE THE DISCOVERY OF THIS VIRUS HAS BEEN THE ZIEA EBOLA VIRUS SUB SPECIES THIS IS A TYPICAL CLINICAL COURSE, IT'S IMPORTANT, I WANT TO POINT OUT A COUPLE THINGS TO YOU. FROM THE TIME OF EXPOSURE, INCUBATION PERIOD, ALTHOUGH USUALLY AROUND 8 TO 10 DAYS THE RANGE IS 2-21 DAYS. THE 21 DAY IS IMPORTANT BECAUSE WHEN THE PUBLIC HEALTH SERVICE -- EXCUSE ME, WHEN THE W HO DECLARES AN OUTBREAK ENDED, IT HAS TO BE 21 DAYS FOLLOWING THE LAST RECOGNIZED CASE. AND THAT WILL BE RELEVANT TO WHAT WE'RE TALKING ABOUT WITH THE CURRENT OUTBREAK. THE SYMPTOMS BEGIN AND THEY RAPIDLY PROGRESS WITH WEAKNESS, FEVER, VOMITING, DIARRHEA, HYPOTENSION AND MULTIPLE ORGAN SYSTEM FAILURE WHICH IN A HIGH PERCENTAGE OF CASES LEADS TO DEATH. SO LET'S JUST GO HISTORICALLY BEFORE WE GET TO THE CURRENT SITUATION THAT WE'RE DEALING WITH. PROBABLY NOT VERY WELL APPRECIATED AMONG THE GENERAL PUBLIC IS THE FACT THAT WE HAVE HAD ABOUT 24 EBOLA OUTBREAKS SINCE THE TIME IT WAS DISCOVERED IN 1976, OF VARYING SIZES, RANGING FROM TWO TO THREE PEOPLE TO A FEW HUNDRED PEOPLE, UNTIL THE 2014 TO 2016 OUTBREAK. SO WHAT WAS DONE IN A PAPER IN NATURE WAS TO FROM A SPHIENTD OF VARIATION -- STANDPOINT OF VARIATION IN SIZES OF THE CIRCLES, TO SHOW YOU SOME OF THE REPRESENTATIVE OUTBREAKS THAT HAVE OCCURRED SINCE THE ORIGINAL OUTBREAK IN ZA DPRI ER, THE DEMOCRATIC REPUBLIC OF THE CONGRESS, FROM 1976 TO 2014-2016 THIS IS WHAT HAPPENED IN 2014 AND I SHOW IT TO YOU BECAUSE IT'S IN MARKED CONTRAST TO WHAT WE'RE SEEING RIGHT NOW IN THE DEMOCRATIC REPUBLIC OF THE CONGO WE'VE REFERRED TO THE OUTBREAK IN WEST AFRICA AS THE PERFECT STORM FOR EBOLA OUTBREAK, AND I THINK YOU CAN SEE IT ON THIS SLIDE BECAUSE IF YOU LOOK AT BEGIN ANY, THE -- AT GUINEA, THE WAY IT WRAPS ITSELF AROUND SIERRA LEONE AND LIBERIA, THOSE BORDERS IN A POPULUS AREA THAT HAD NO PRIOR EXPERIENCE WITH EBOLA VIRUS. UNLIKE THE DEMOCRATIC REPUBLIC OF THE CONGO. AND THE FIRST CASE WAS IN DECEMBER OF 2013 IN GUINEA, IT WENT UNRECOGNIZED UNTIL WE GOT TO MARCH OF 2014, THAT WAS ONE OF THE BIG LESSONS OF THE INABILITY TO COMMUNICATE THE BEGINNING OF AN OUTBREAK WHICH LED ULTIMATELY TO ESSENTIALLY A REGIONAL CATASTROPHE. THIS IS WHAT HAPPENED. NOTICE THE BIG CITIES OF MONROVI A, FREE TOWN AND CONITRE IN THE THREE RESPECTIVE COUNTRIES. OVER A PERIOD OF MONTHS THIS IS WHAT WE SAW. THE SPREAD TO THE POINT WHERE ESSENTIALLY THE ENTIRE COUNTRY WAS INVOLVED. THE IRB USE WITH VIRAL HEMORRHAGIC FEVER IS THEY HAVE A HIGH DEGREE OF LETHALITY AND HIGH DEGREE OF INEFECTIVITY OF WHICH WE SOMETIMES GET CONFUSED. INIF HE CAN ACTIVITY IS HIGH WHEN YOU HAVE DIRECTED -- INEFECTIVITY IS HIGH WHEN YOU HAVE HIGH CONTACT WITH THE PATIENTS, UNLIKE INFLUENZA, WHICH CAN BE SPREAD IN AN AIRPLANE OR ELEVATOR, YOU HAVE TO HAVE DIRECT CONTACT. THERAPY IS MAINLY SUPPORTIVE. AT THE TIME A VACCINE WAS NOT AVAILABLE. NOW, WHEN THIS FIRST CAME OUT, I WROTE A COMMENTARY IN THE NEW ENGLAND JOURNAL OF MEDICINE AND I ENTITLED IT: UNDERSCORING THE GLOBAL DISPARITIES IN HEALTHCARE RESOURCES, AND THE POINT I MADE IN THIS SHORT COMMENTARY IS THAT WITHOUT THE ADVANTAGE OF HIGH-TECH INTERVENTIONS LIKE ANTIMICROBIALS, INTIE VIRALS, VACCINES, THAT YOU CAN ACTUALLY BLOCK AN EPIDEMIC BY THE SOUND PUBLIC HEALTH PRACTICES. AND AS A MATTER OF FACT, THESE ARE THE PUBLIC HEALTH RESPONSES TO EBOLAS IN THE EFFECTIVE COUNTRIES. VERY, VERY CLEARLY, THERE'S NOTHING THERE THAT IS ESSENTIALLY A MEDICAL INTERVENTION. THERE'S EDUCATION, HYGIENIC PRACTICES, IDENTIFICATION, CONTACT TRACING, ISOLATION, SAFE BURIALS AND AGGRESSIVE SUPPORTIVE CARE. THIS IS WHAT HAPPENED EARLY ON IN THE OUTBREAK. AS SOME OF YOU MAY REMEMBER, THE UNITED STATES, AMONG OTHER GROUPS AND OTHER AGENCIES, THROUGHOUT THE WORLD AND OTHER COUNTRIES, HAD A VERY STRONG RESPONSE TO THE EBOLA OUTBREAK. PRESIDENT OBAMA TOOK A VERY PERSONAL INTEREST IN THIS. IT'S REALLY EXTRAORDINARY THAT DURING THE OUTBREAK THAT I HAD THE OPPORTUNITY TOGETHER WITH SECRETARY BURWELL AND TOM FREEDA N OF THE CDC TO MEET AT LEAST 15 TIMES WITH THE PRESIDENT OF THE UNITED STATES ABOUT THIS. IT WAS REALLY AN EXTRAORDINARY SITUATION. WE HAD MEETINGS IN THE SITUATION ROOM AND EVEN IN THE OVAL OFFICE ABOUT THIS VERY FREQUENTLY. WHEN WE SENT IN PEOPLE, WE, THE GLOBAL HEALTH COMMUNITY TORQUE ASSIST, AND THE CDC WAS VERY HEAVILY REPRESENTED THERE, AS WAS METSON FRONTIER, YOU WOULD EXPECT, SINCE PEOPLE WITH THE HIGHEST RISKS ARE HEALTHCARE WORKERS AND PEOPLE WHO WERE INVOLVED IN CARING FOR THE DEAD, FUNERAL WORKERS AND UNDERTAKERS, THAT PEOPLE WERE GETTING INFECTED. AND WHEN THEY GOT INFECTED, THEY GOT AIR-EVACKED TO VARIOUS PLACES THROUGHOUT THE WORLD DEPENDING UPON THEIR COUNTRY OF ORIGIN. THE NIH WAS ONE OF THREE AND STILL IS DESIGNATED EBOLA TREATMENT FACILITIES, DUE TO OUR SPECIAL CLINICAL STUDIES UBT UBT UNIT. HISTORICALLY THE SPECIAL CLINICAL STUDIES UNLTD AS PART. CLINICAL CENTER WAS ESTABLISHED ORIGINALLY FOR THE PURPOSE OF INDIVIDUAL SCIENTISTS WHO MIGHT BE INVOLVED IN STUDIES OF HIGH CONTAINMENT REQUIRED ORGANISMS THAT MIGHT HAVE AN ACCIDENT IN THE LABORATORY. ORIGINALLY THAT WAS TAKEN CARE OF IN FREDERICK MARYLAND AT FORT DIETHRICH BUT WE ASSUMED THE RESPONSIBILITY A FEW YEARS LATER , SO WE BECAME ONE OF THE COMPONENTS THAT RESPONDED. THIS IS JUST SOME HISTORICAL PICTURES. AS FRANCIS MENTIONED, WE TOOK CARE OF TWO EBOLA PATIENTS, ONE OF WHICH WAS VERY HIGHLY PUBLICIZED, THIS IS NINA FAMM, THIS IS A PICTURE OF FRANCIS AND I AND CLIFF LANE PUBLICLY DISCHARING NINA FAMM IN FRONT OF THE CLINICAL CENTER, AND ON THE RIGHT IS OUR NURSES WHO VERY MUCH ARE SNROSTLED HER CARE. TSMS VERY IMPORTANT TO HAVE THIS PUBLIC DISCHARGE AND PURGT MY ARM AROUND -- AND PUTTING MY ARM AROUND HER BECAUSE AT THE TIME THERE WAS AN EXTRAORDINARY AMOUNT OF STIGMA, NOT ONLY AGAINST INDIVIDUALS WHO RECOVERED FROM EBOLA BUT FROM THE HEALTHCARE WORKERS WHO WERE ACTUALLY TAKING CARE OF THEM. AND WE HAD SOME VERY INTERESTING EXPERIENCES HERE WITH RELUCTANCE OF PEOPLE TO COME NEAR SOME OF US WHO WERE TAKING CARE OF EE EBOLA PATIENTS, WHICH TELLS YOU THAT EVEN IN A HIGHLY EDUCATED GROUP ABOUT TRANSMISSION MISSION , THERE'S A LOT OF MISPERCEPTIONS AND MISCONCEPTION S ABOUT THE TRANCE MISS SIBILITY. BUT THE ONE THAT TAUGHT US THE MOST IMPORTANT LESSON ABOUT WHAT THE ROLE OF INTENSIVE CARE IS IN A DISEASE THAT WAS OTHERWISE FELT TO BE AS HIGH AS 90% LETHAL WAS OUR EXPERIENCE WITH ANOTHER PATIENT WHO WE WILL NOT NAME BECAUSE HE WANTED TO REMAIN COMPLETELY ANONYMOUS. WHAT WE DID, WE MOBILIZED, HERE IS PART OF OUR TEAM, AND THE TEAM WAS ORGANIZED BY RICK DAVY WHO IS THE DIRECTOR OF THE SPECIAL CLINICAL STUDIES UNIT, A MEMBER OF NIAID BUT HE ALSO HAS ANOTHER ROLE AND IS MADE UP OF A COMBINATION OF INFECTIOUS DISEASE EXPERTS, INTENSIVE CAR ISTS AND A GROUP OF INTENSIVE CARE AND INFECTION DISEASE NURSES. SO THIS IS US HERE IN MARCH OF 2015 TAKING THIS PATIENT UP THROUGH THE BACK ELEVATOR OF THE NIH CLINICAL CENTER TO OUR SPECIAL CLINICAL STUDIES UNIT, AND IT WAS A VERY WELL TRAINED PROCESS IN WHICH WE ALL HAD TO BE CERTIFIED AND TESTED BY A GROUP OF NURSES WHO DID NOT CARE IF YOU WERE THE DIRECTOR OF THE NIH OR IF YOU WERE JUST A PARTICULAR IN THE TRENCHES NURSES, YOU COULDN'T GET INTO THE ROOM UNLESS YOU WERE QUALIFIED AND TRAINED. SO THIS IS A PICTURE OF DAN CHER TOW AND I, THIS PICTURE WAS TAKEN ABOUT 2:45 IN THE MORNING. I TRY TO KEEP MY JOB AS THE DIRECTOR OF NIAID AT THE SAME TIME AS I DID THIS, SO I HAD THE NIGHT SHIFTS WITH DAN, WHO WAS AMAZING. DAN HAD SPENT THE MONTH IN LIBERIA AND SIERRA LEONE TAKING CARE OF PATIENTS DURING THE OUT BREAK, SO HE WAS A GREAT MENTOR TO ALL OF US ABOUT HOW TO TAKE CARE OF THESE PATIENTS. THIS IS ME GETTING READY TO GO INTO THE ROOM, AND THIS IS DAN AND I IN AND THIS PATIENT WHO HAD MULTIPLE ORGAN SYSTEM FAILURE. FOR THOSE WHO WERE INTERESTED IN THE CLINICAL ASPECTS OF IT, I'LL TAKE 30 SECONDS TO TELL YOU, THE IMPORTANT THING ABOUT THIS IS THAT WE WERE ALL UNDER THE IMPRESSION THAT PEOPLE WHO GET MULTIPLE ORGAN SYSTEM FAILURE GET SO BECAUSE THEY EITHER GET DEHYDRATED OR BLEED OUT AND GET HYPOTENSIVE WITH MULTIPLE ORGAN SYSTEM FAILURE. THAT WAS ABSOLUTELY NOT THE CASES. THIS PATIENT WAS PLUGGED IN IN INTENSIVE CARE AND NEVER FOR A MINUTE DID HIS BLOOD PRESSURE DROP BELOW THE NORMAL LEVEL, YET OVER A PERIOD OF SEVERAL DAYS TO WEEKS, HE DEVELOPED PROGRESSIVE LY CARDIOPULMONARY FAILURE, MYOCARDITIS, CR MENIGAL ENCEPHALITIS AND RENAL FAILURE. HE WAS FINALLY DISCHARGED WELL AND WAS STILL SEEING HIM IN CLINIC ABOUT EVERY SIX MONTHS DOING VERY WELL. NOW, THE ISSUE THAT WAS IMPORTANT WAS THE RESEARCH ENDEAVOR THAT WE AT NIH DID AND A TYPICAL THING WE DO WITH EVERY DISEASE BASIC AND CLINICAL RESEARCH FOR THE OPPORTUNITY TO DEVELOP VACCINES, THERAPEUTICS AND DIAGNOSTICS. AND JUST HISTORICALLY WHAT HAPPENED IS THAT THE VSV VACCINE THE FIRST CLINICAL TRIAL WAS DONE AT THE NIH CLINICAL CENTER JUST A FEW HUNDRED YARDS FROM THIS BUILDING. IN ADDITION, CLIFF LANE ESSENTIALLY DEVOTED MUCH OF A YEAR DEVELOPING A RESEARCH COMPONENT IN LIBERIA, AND THIS IS A PICTURE OF CLIFF SPEAKING AT THE OPENING CEREMONY FOR THE PREVAIL STANDS FOR PARTNERSHIP FOR RESEARCH ON EBOLA VIRUS IN LIBERIA. IF YOU JUST FOCUS ON THIS SLIDE, EACH OF THESE CLINICAL RESEARCH PROJECTS CONDUCTED DURING THE OUTBREAK ITSELF, FROM THE VACCINE TRIAL TO THE ZMAM STUDY TO THE STUDY OF SURVIVORS, AND THE RESEARCH YIELDED RESULTS. THIS IS A STUDY THAT WAS RUN BY RAKE DAVEY AND CLIFF LANE WHICH WE PUBLISH IN THE NEW ENGLAND JOURNAL IN WHICH WE DID A RANDOMIZED CONTROL TRIAL OF EXPWHR MA -- OF ZMA OF EBOLA VIRUS, THE N WASN'T BIG ENOUGH BECAUSE FROM DR. THE OUTBREAK DIED DOWN BEFORE WE HAD ENOUGH PATIENTS, BUT STRONG TREND TOWARDS EFFICACY. DID PHASE II PLACEBO CONTROLLED TRIAL OF THE Z MAP CONCERN, TOGETHER WITH THE CAN VACCINE WHICH WAS A CHIMP ADENO AND THE VSV WAS USE IN AN OPEN LABEL RING VACCINATION STUDY AND SHOWN TO BE EFFECTIVEMENT NOW, THE IMPORTANT PART THAT I WANT TO JUST LEAVE YOU WITH IS THAT THE NATIONAL ACADEMY OF MEDICINE DID A STUDY EXAMINING WHAT HAPPENED DURING THAT OUTBREAK AND IS SOMETHING THAT WE INSISTED UPON AT NIH THAT YOU COULD CONDUCT ETHICALLY SOUND SCIENTIFICALLY SOUND RESEARCH IN THE MIDDLE OF AN OUTBREAK WITHOUT COMPROMISING EITHER ETHICS OR SCIENCE, AND THEY CAME OUT VERY STRONGLY WITH THAT. SO NOW FAST TBOORTD CURRENT SITUATION. WE HAVE AN JOWLT BREAK IN THE DEMOCRATIC REPUBLIC OF THE CONGO THIS NUMBER YOU'LL SEE, IT GOES FROM 55 TO 62, BACK DOWN TO 55, PEOPLE WONDER WHY DOES IT GO UP TO 60 AND THEN BACK TO 50? BECAUSE THEY COUNT BOTH CONFIRMED, PROBABLE AND SUSPICIOUS CASES. WHEN A SUSPICIOUS CASE IS RULED OUT AS NOT BEING EBOLA, THEN THE NUMBER OF TOTAL CASES GOES DOWN. SO DON'T GET CONFUSED BY THAT. SO THERE ARE A COUPLE OF KEY CHANGES IN THE DIFFERENCE BETWEEN THEN AND NOW, AND I'LL SPEND THE LAST MINUTE OR TWO ON THAT. FIRST, BETTER COORDINATION AT THE INTERNATIONAL LEVEL. A MAJOR DIFFERENCE BETWEEN OUR RELATIONSHIP WITH WHO THEN AND OUR RELATIONSHIP WITH WHO NOW. THAT HAS A LOT TO DO WITH A NUMBER OF FACTORS BEING BUT ONE OF THE MOST IMPORTANT WAS THE SLIDE THAT FRANCIS SHOWED OF TED ROS COMING HERE, SIGNING A MEMORANDUM OF UNDERSTANDING AND INVOLVED NOT ONLY WITH US BUT ESSENTIALLY WITH EVERYONE ELSE THROUGHOUT THE WORLD WHO IS GETTING INVOLVED. THE NEXT WAS EXPERIENCE IN COUNTRY. THE DRC WAS THE COUNTRY IN WHICH THE EBOLA VIRUS WAS FIRST DISCOVERED IN 1976, AND THIS IS A PICTURE OF SOME OF THE INDIVIDUALS INVOLVED WITH THAT. JOEL BREMMER, ONE OF OUR OWN HERE AT THE NIH WAS ONE OF THE TEAM THAT DISCOVERED THE EBOLA VIRUS. DRC, THIS IS THEIR NINTH OUT BREAK, SO AS MUCH OF A POOR COUNTRY THAT THE DRC IS, THEY ARE VERY GOOD AND VERY EXPERIENCED ABOUT HOW YOU HANDLE IDENTIFICATION, CONTACT TRACING AND ISOLATION. THE NEXT IS STRONG PREEXISTING PARTNERSHIPS. WE HAD A PARTNERSHIP WITH THE DR C THAT GOES BACK MANY YEARS, IN FACT, ONE OF THE MONOCLONAL ANTIBODIES THAT WE HAVE OFFERED TO BE ABLE TO BE USED IN THE DRC WAS FROM A SURVIVOR OF THE 195 KICK WIC OUTBREAK AND THE MINISTER OF HEALTH, AND THIS IS SOMETHING THAT IS UNUSUAL, BUT I THINK IT JUST BESPEAKS THE IMPORTANT INTERACTION AND COLLABORATIONS AMONG COUNTRIES. THE MINISTER OF HEALTH. DRC WITHIN DAYS WROTE ME A LETTER ASKING IF WE COULD HELP OUT BY SENDING THE MONOCLONAL ANTIBODY AS WELL AS A TEAM TO INSTRUCT THEM HOW TO USE THAT. THIS IS REALLY UNPRECEDENTED WHEN YOU THINK IN OUTBREAKS. FINALLY THERE ARE A NUMBER OF COUNTERMEASURES WITH EVIDENCE WITH ROBUST CLINICAL TRIALS. WE NOW HAVE A MUCH BETTER DIAGNOSTIC THAT IS ESSENTIALLY MODEL THE AFTER THE GENE EXPERT THAT WAS STARTED WITH TUBERCULOSIS, IT'S NOW BEEN EX- TRAP THRIETD EBOLA. WE HAVE SPENT SOME OF OUR ROCKY MOUNTAIN PEOPLE WHO HAVE GONE OVER NOT ONLY TO THE DRC BUT ALSO TO BRAZIVILLE IN CASE IT SPREADS THERE. VACCINE IS BEING USED IN A VACCINATION RING STUDY, 50 RINGS HAVE BEEN IDENTIFIED WITH 150 VACCINATIONS PER RING AND FINALLY AS YOU CAN SEE, THE EPIDEMIC AS YOU MEASURED HERE BY THE BLUE BARS HAS WE HOPE PEEKED WHICH IS COMING DOWN -- PEAKED AND IS COMING DOWN. THE REASON I SHOWED U THE I THINK BASE PERIOD THERE IS THAT NO ONE SHOULD EVER CLAIM VICTORY IN EBOLA UNTIL YOU ARE 21 DAYS PAST THE LAST RECOGNIZED CASE. AS YOU CAN SEE FROM THE DATES ON THE SLIDE WE'RE NOT BUT HOPEFULLY WE'LL GET THERE. SO I'LL STOP THERE AND I'LL BE HAPPY TO ANSWER ANY QUESTIONS. >> Francis Collins, MD: THANKS FOR THAT SPECTACULAR REVIEW OF WHERE WE'VE BEEN AND WHERE WE ARE NOW. LET ME STOP AND ASK QUESTIONS. DO THE ACD WANT TO POSE ANY? >> THANKS FOR THAT UPDATE. GIVEN THE 21-DAY INCUBATION PERIOD THAT YOU MENTIONED, HOW ARE WE DOING WITH RESPECT TO PRE SYMPTOMATIC DETECTION AND SCREENING TOOLS IN THE SETTING OF AN OUTBREAK THAT COULD IDENTIFY PEOPLE WHO ARE EXPOSED BUT HAVE YET TO DEVELOP SYMPTOMS >> YEAH, THAT'S A VERY GOOD QUESTION. WE PARTICULARLY WITH THESE NEW OUTBREAKS ARE TRYING TO SEE IF WE CAN GET A SITUATION WHERE WE CAN GET MORE EARLY STAGE VIREMIA , IF YOU LOOK AT IT, IF YOU GET LOW LEVELS OF VIREMIA THAT WE COULD PROBABLY DETECT BY THIS GENE EXPERT APPROACH BEFORE PEOPLE BECOME SYMPTOMATIC. WE'RE TRYING TO DO THAT AROUND SOME OF THE CACTSZ. WE WERE UNABLE TO DO THAT BEFORE BECAUSE WE HAD NO STATE OF THE ART POINT OF CARE DIAGNOSTIC. I DON'T HAVE ANY RESULTS YET BECAUSE WE'RE STILL IN THE VERY EITHER STAGES OF THAT. BUT THAT'S A GOOD QUESTION. YEAH. >> WHICH IS THE VACCINE YOU'RE USING, WHERE IS IT IN THE PRODUCT DEVELOPMENT CYCLE? IS IT A CLEN CAL TRIAL ONGOING? >> IT'S AN INTERESTING -- A GOOD QUESTION AND AN INTERESTING SITUATION. A LITTLE COMPLICATED. LET ME TRY TO MAKE IT AS SIMPLE AS POSSIBLE. IT'S THE FROM MERCK VSV WITH THE EXPRESSION OF THE GENE. IT WAS USED IN A PHASE I TRIAL HERE, IN A PHASE II TRIAL WITHOUT ANY CASES BECAUSE WHEN WE DID IT IN LIE BEER YARKS THE CASES STARTING TO COME DOWN. AT THE LAST MINUTE IT WAS USED IN A RING VACCINATION STUDY IN G UINEA, IT WAS PUBLISHED IN LANCET BUT THE PROBLEM WAS EVEN THOUGH IT WAS PROFESSED I THINK APPROPRIATELY SO TO BE EFFECTIVE , THE DESIGN OF A RING VATION NATION STUDY, AS YOU WELL KNOW, IS NOT A RANDOMIZED CONTROL TRIAL SO THE REGULATORY AUTHORITIES HAVE NOT BEEN ABLE TO ESSENTIALLY APPROVE IT AS A LICENSED PRODUCT IN A COUNTRY YET SO WHAT ARE WE DOING TO GET THERE? WE HAVE VERY GOOD ANIMAL DATA, WE ARE CONTINUING A LARGE PHASE II B TRIAL OF THE VSV AGAINST AN ADENO2-6RBGS EVEN THOUGH THERE ARE NO -- 26, EVEN THOUGH THERE ARE NO CASES IN WEST AFRICA, WE'RE CONTINUING IT, SO HOPEFULLY WE'LL GET A FEW THOUSAND PEOPLE. IF WE GET GOOD SAFETY DATA AND GOOD IMMUNOGENICITY DATA THAT WE COULD BRIDGE TO THE ANIMALS, THE FDA, THOUGH THEY'LL NEVER PROMISE ANYTHING, AND I THINK APPROPRIATELY, SO SAID THEY WOULD SERIOUSLY CONSIDER AN ACCELERATED APPROVAL IF WE GET ENOUGH SAFETY PLUS IMMUNO GENICITY PLUS BRIDGING DATA. BUT ON THE BASIS OF THE ORIGINAL RING VACCINATION STUDY, IT'S NOT BEEN APPROVED. SCOL COL S DL. >> Francis Collins, MD:TONY, THANK YOU VERY MUCH FOR GIVING US SUCH AN ELEGANT PRESENTATION ABOUT A TOPIC MUCH ON PEOPLE'S MINDS. WE'RE ALL HOLDING OUR BREATH BUT I MUST SAY COMPARED TO WHAT WE SAW IN WEST AFRICA WHERE THE NUMBER OF NEW CASES BEGAN TO RISE EXPONENTIALLY, THIS LOOKS VERY PROMISING INDEED. I KNOW THE BIG CONCERN WAS WHETHER THIS WOULD FIND ILTS WAY INTO A MAJOR CITY AND OF COURSE IT DID, BUT IT IS SO FAR BEEN CONTAINABLE. MUCH CREDIT TO ALL OF THE WORLDWIDE RESPONSE. GIVEN THAT WE'VE JUST HEARD ABOUT A VERY SIGNIFICANT GLOBAL HEALTH PROBLEM, I JUST THOUGHT I WOULD SAY A WORD OR TWO ABOUT A COUPLE OTHER THINGS THAT ARE HAPPENING WITH NIH'S SUPPORT OF GLOBAL HEALTH AND PART OF THIS COMES THROUGH THE COMMON FUND WHICH HAS AN INITIATIVE TO STRENGTHEN BIOMEDICAL RESEARCH CAPACITY IN AFRICA. THAT IS NOW LED TO THE ANNOUNCEMENT OF SOMETHING CALLED HEPI, THE HEALTH PROFESSIONAL EDUCATION PARTNERSHIP INITIATIVE , WHICH IS A SUCCESSOR TO A PROGRAM THAT WE CO- SUPPORTED WITH PEPFAR CALLED THE MEDICAL EDUCATION PARTNERSHIP INITIATIVE. AGAIN, ENHANCING MEDICINE AND NURSING EDUCATION THROUGH CURRICULAR AND OTHER MEASURES. WE ARE HAPPY TO SAY THAT THE PROGRAM THAT WAS STARTED JOINTLY WITH THE WELCOME TRUST CALLED H3 AFRICA, HUMAN HEALTH AND HEREDITY IN AFRICA, HAS MOVED INTO ITS SECOND FIVE-YEAR PHASE WITH THE AWARD OF A NEW SET OF GRANTS FROM NIH AND FROM WELCOME THIS IS A PROJECT WHICH INVOLVES MORE THAN 500 INVESTIGATORS IN 29 AFRICAN COUNTRIES, 48 RESEARCH PROJECTS, 60,000 RESEARCH PARTICIPANTS INCLUDING BIOSPECIMENS THAT ARE CONSENTED FOR FUTURE USE, 80,000 DNA SAMPLES AVAILABLE WITH MOST OF THOSE OR HALF OF THOSE ANYWAY ALREADY IN H3 AFRICA BIO REPOSITORIES, BUILDING OF AN INTERNET CONNECTION BETWEEN THESE INSTITUTIONS AND GROWING STRENGTH IN BILE OH INFORMATICS EXPET IKS WORK -- BIOINFORMATICS AND ETHICS WORKING GROUP FOR THE SAMPLING HANDLING, AND I THINK REALLY A REMARKABLE EXAMPLE OF NOW WE ARE SEEKING TO MOVE THE CENTER OF GRAVITY FOR A LEADERSHIP OF AFRICAN RESEARCH TO AFRICA AND PUT IT INTO THE HANDS OF PRINCIPAL INVESTIGATORS AND THEIR INSTITUTIONS WITH WHAT I THINK HAS BEEN A REALLY REMARKABLE POSITIVE EXPERIENCE. WE CONTINUE BUILDING ON THAT BETWEEN HEPI AND H3 AFRICA AND OTHER EXPERIENCES, AND AGAIN WORKING WITH COLLEAGUES AT THE WELCOME TRUST AND THE GATES FOUNDATION TO SUPPORT NOTION OF A COALITION FOR AFRICAN RESEARCH AND INNOVATION, CARI, WHICH HAS NOW BEEN PRESENTED ON NUMEROUS PLACES INCLUDING AT THE WORLD ECONOMIC FORUM TO SEE WHETHER WE COULD SEE A MODEL DEVELOP WHERE THERE IS AN OPPORTUNITY TO BUILD RESEARCH CAPACITY ACROSS SUBSAHARAN AFRICA BY PROVIDING APPROPRIATE RESOURCES, BUT DOING SO IN A FASHION THAT GETS AWAY FROM THE TRADITONAL COLONIAL MODEL WHERE THE RESEARCH IS PRETTY MUCH DIRECTED FROM OUTSIDE THE CONTINENT TO WHERE IT CAN BE IN FACT EMBRACED AND SUPPORTED AND LED BY PEOPLE WHO HAVE THE BEST IDEA ABOUT WHAT RESEARCH QUESTIONS ARE MOST IMPORTANT TO ASK. THIS OF COURSE VOFLTZ THE NEED THEN TO ENGAGE AFRICAN GOVERNMENTS TO SEE THIS AS A WORTHWHILE INVESTMENT AS OPPOSED TO AGAIN THE TRADITIONAL MODEL WHERE THOSE RESOURCES CAME FROM OUTSIDE. KIND OF TO PUT IT INTO A PHRASE, MOVING FROM A DONORSHIP TO OWNERSHIP OF MEDICAL RESEARCH IN AFRICA. THERE IS AN EFFORT NOW TO PUT TOGETHER A BUSINESS PLAN FOR CAR I, THERE'S BEEN A WONDERFUL WORKING GROUP ASSEMBLED WITH MUCH HELP FROM PAUL STOFL FROM J NJ, PHARMACEUTICAL COMPANIES, CONDUCTED A LANDSCAPE ANALYSIS OF WHAT THE CURRENT RESOURCES LOOK LIKE ON THE CONTINENT IN TERMS OF CLINICAL AND TRANSLATIONAL RESEARCH AND MUCH MORE TO COME ON THIS. SO I'M SURE I'LL BE REPORTING BACK TO THIS GROUP AT A LATER DATE, BUT I JUST WANTED YOU TO KNOW THE MOMENTUM HERE IS EXCITING TO SEE, AND IT HELPS ALSO THAT WE HAVE THE STRONG SUPPORT OF THE AFRICAN ACADEMY OF SCIENCES, OF NEPAD, OF THE AFRICAN UNION AND IN NAIROBI THE AFRICAN EFFORT THAT WAS PARTICULARLY ENCOURAGED BY WELCOME TRUST, THE AFRICAN EXCELLENCE IN SCIENCE IN AFRICA, LED BY TOM CARIUK I, SO WE HAVE QUITE A CRITICAL MASS HERE OF DETERMINED EFFORTS. BUT LET'S MAKE NO MISTAKE, THIS IS CHALLENGING TO TRY TO CHANGE LONG-STANDING DYNAMIC INTO SOMETHING THAT IS GOING TO BE MORE PRODUCTIVE, AND HERE I HAVE TO GIVE MY SHOWLT OUT TO -- SHOUT OUT TO REIMAGINER GLASS AND ROB ES YOU SITTING OVER THERE FOR THEIR WISE ADVICE ABOUT HOW LTS THAT WE MIGHT TURN THIS INTO A SUCCESS. ONE OTHER INITIATIVE THAT I WANT TO MENTION TO YOU, WHICH HAS JUST RECENTLY COME TOGETHER AND WAS A SIGNIFICANT ITEM IN THE FY 18 OMNIBUS APPROPRIATIONS REPORT WAS AN ENCOURAGEMENT FOR NIH TO DEVELOP A TRANS-NIH APPROACH TO ADDRESS THE CRITICAL HEALTH AND QUALITY OF LIFE NEEDS FOR INDIVIDUALS WITH DOWN'S SYNDROME OF THE LARRY TABAK, DIANA WI BIANCI AND GARY GIBBONS HAVE BEEN WORKING ON HOW WE MIGHT RAMP UP OUR EFFORTS IN THIS REGARD BECAUSE IT AFFECTS A WIDE VA RIGHT ORGAN SYSTEMS AND YOU CAN -- WIDE VARIETY OF ORGAN SYSTEMS, IN CHILD HEALTH AND VIROLOGY AND OTHER PLACES INCLUDING HEART LUNG AND BLOOD AND SO ON, INDIVIDUALS WITH DOWN'S SYNDROME SEEM TO HAVE A MUCH LOWER AGE ADJUSTED DR. CORONARY DPL ARTERY DISEASE AND OF CANCER AND WE DON'T KNOW WHY THAT IS. SO WORKSHOPS BEING PLANNED, ENGAGEMENT WITH STAKEHOLDERS, SOME DAICIALG ADMINISTRATIVE SUPPLEMENTS WITH OTHER FUNDS EXPECTED TO COME FORWARD IN FY19 , SOMETHING WE BELIEVE IS HIGHLY APPROPRIATE, WE WEREN'T TALKING ABOUT A HUGE AMOUNT OF MONEY HERE BUT IT IS I THINK A GOOD INITIATIVE AND CERTAINLY ONE THAT THE CONGRESS HAS ENCOURAGED US TO LOOK AT. WITH THAT IN THE WAY OF HITTING SOME HIGH POINTS, MUCH OF THE REST OF HIGH POINTS WILL BE HIT IN OTHER PRESENTATIONS, I WANT TO ASK FOR NEIL SHAPIRO, OUR BUDGET OFFICER, TO TELL US SOMETHING ABOUT WHERE WE ARE WITH THE BUDGET SITUATION AND THEN ADRIAN HALLETT WHO WILL COME AND TALK ABOUT LEGISLATIVE UPDATES. AND THEN I THINK AT THAT POINT IF YOU HAVE OTHER THINGS TO DISCUSS, WE'LL INVITE THOSE. I THINK WE ARE DOING PRETTILY -- PRETTY WELL HERE AT STAYING ON SCHEDULE. BUT NEIL THE FLOOR IS YOURS. >> THANK YOU, FRANCIS, GOOD MORNING, EVERYONE. IN TERMS OF THE BUDGET THIS YEAR , LET ME STARTED WITH HOW WE BEGAN THE FISCAL YEAR WITH A SERIES OF FIVE CONTINUING RESOLUTIONS. AS I THINK YOU ALL RECALL, UNTIL WE HAVE OUR ACTUAL APPROPRIATION S, THERE ARE PROVISIONS TO ALLOW THE GOVERNMENT TO KEEP FUNCTIONING AND WE GOT A SERIES OF THOSE, INCLUDING YOU MAY NOTE IN JANUARY WE HAD A WEEKEND SHUT DOWN IN BETWEEN THE THIRD AND THE FOWRLT ONE, AND AS -- AND THE FOWRLT ONE, AND AS THESE WENT O THE CONGRESS WAS WORKING THROUGH ITS VARIOUS FISCAL PRIORITIES FOR THE YEAR AND IN TERMS OF THE ORDER OF THINGS IN WHICH THEY PASS BILLS, THEY STARTED OUT WITH TAX REFORM AND THEN MOVED FROM THERE TO THE BROADER BUDGET ISSUE OF DISCRETIONARY CAPS AND THEN FINALLY TO THE ACTUAL APPROPRIATIONS BILLS, WHICH DIDN'T PASS UNTIL MARCH 23RD. SO WE OPERATE UNDER A CONTINUING RESOLUTION DURING THAT PERIOD. IT DOES TEND TO SLOW THINGS DOWN A BIT. AND WE ALSO TYPICALLY WILL MAKE OUR NONCOMPETING GRANTS AT 90% OF THEIR COMMITTED LEVEL JUST IN CASE, UNTIL WE KNOW WHAT OUR FINAL APPROPRIATIONS ARE, SO THAT DOES TEND TO HOLD THINGS UP A BIT, BUT IT ALL WORKED OUT IN THE END. I DID WANT TO POINT OUT THAT THE FINAL BILL, THE ONE THAT PASSED ON FEBRUARY 9TH, THE CONTINUING RESOLUTION WAS PART OF THE ARE BIPARTISAN BUDGET ACTED AND THAT HAD A NUMBER OF THINGS WHICH APPLIED TO US, THE FIRST PART AS I MENTIONED AN INCREASE IN THE DISCRETIONARY CAPS. SO THE EXISTING CAPSZ THAT HAD BEEN IN PLACE FOR SOME YEARS NOW AHAD THE MOST RECENT ADJUSTMENT TO IT, ENDED IN 2017, SO THERE WAS A POINT AT WHICH THERE WOULD NOT HAVE BEEN AS MUCH FUNDING FOR DISCRETIONARY PROGRAMS SUCH AS OURS AVAILABLE IF THE CAPS DIDN'T GO UP, SO PART OF BARM BUDGET ACT WAS TO INCREASE THOSE CAPS OVER TWO YEARS, AND I THINK ADRIAN WILL STALK MORE ABOUT THAT NEXT. THE SECOND PARTED IMPORTANT FOR US WAS REAUTHORIZATION OF THE SPECIAL DIABETES PROGRAM, THIS IS CONSIDERED MANDATORY FUNDING SO IT DOESN'T GET INCLUDED IN THE ANNUAL APPROPRIATIONS ACT, AS A RESULT, IT NEEDS ITS OWN LEGISLATION AND THE PREVIOUS LEGISLATION AGAIN ONLY WENT THROUGH 2017 SO WE NEEDED THAT CONTINUED, SO IN THIS BILL THERE WAS A TWO-YEAR CONTINUATION AT THE SAME FUNDING LEVEL OF $150 MILLION. THE LAST PIECE HERE WAS FOR HURRICANE RECOVERY FOR THE STORMS LAST YEAR, A NUMBER OF RESEARCH PROJECTS FUNDED BY NIH WERE AIF HE CAN AND HAD HAD DAMAGE, IN SOME CASES SEVERE DAMAGE FROM THOSE STORMS, SO CONGRESS PROVIDED $50 MILLION OF EMERGENCY SUPPLEMENTAL FUNDS THAT WE COULD AWARD OVER A THREE -YEAR PERIOD TO HELP THOSE PROGRAMS RECOVER FROM THE HURRICANES. THEN WE GOT TO THE 23RD AND OUR ANNUAL APPROPRIATION IN THE OMNIBUS AND IT WAS AN EXCELLENT ONE. $3 BILLION INCREASE OVER THE PRIOR YEAR'S ENACTED LEVEL, SO THE THIRD YEAR IN A ROW IN WHICH WE HAD HAD LARGE INCREASES FROM CONGRESS. THAT INCLUDED A GENERAL INCREASE , SO ACROSS THE BOARD FOR INSTITUTES AND CENTERS, OVER 5% THIS TIME. VERY HEALTHY, AS WELL AS SOME TARGETED INCREASES I'LL TALK ABOUT IN A MINUTE. BUT DID IMENT TO MENTION THAT TOGETHER WITH THE PRIOR TWO YEARS INCREASES, SO $7 BILLION OVER THREE YEARS, THAT WAS A HUGE HELP IN TERMS OF NIH PURCHASING POWER. SO WE LOOK AT HOW OUR BUDGET IS AFFECTED BY INFLATION AND OVER TIME IN RECENT YEARS THE BUDGET HAD NOT BEEN KEEPING UP, AND THIS GRAPH SHOWS YOU IN TERMS OF INFLATION ADJUSTED DOLLARS, REAL DOLLARS, WE HAD A PERIOD FROM 1998 TO 2003, THE DOUBLING OF THE NIH BUDGET, IT IS CALLED, WHERE WE PEAKED IN TERMS OF REAL DOLLARS, AND SINCE 2003 OVER THE NEXT SEVERAL YEARS THROUGH 2015 REALLY THE INFLATION ADJUSTED BUDGET HAD DECLINED BY UP TO 22% AND THE PAST THREE YEARS WITH 2 BILLION, 2 BILLION, AND NOW 3 BILLION, WE HAVE MADE HALF OF THAT SO THAT WE'RE NOW ONLY 11% BELOW THE PURCHASING POWER THAT WE HAD IN PHYSICIANS SCAL 2003 -- IN FISCAL 2003. SO REALLY EXTREMELY HELPFUL RESULTS HELP FROM OUR FRIENDS IN CONGRESS. SO THE TARGET INCREASES THAT I MENTIONED AS PART OF THIS YEAR'S $3 BILLION INCLUDED SEVERAL PROGRAMS THAT YOU'LL BE HEARING ABOUT OVER THE COURSE OF THIS MEETING. OPIOID PAIN RESEARCH DEDICATED INDICATED 500 MILLION DLARKSZ ALZHEIMER'S DISEASE, BRAIN INITIATIVE, ALL OF US RESEARCH PROGRAM AND A NUMBER OF THESE WERE CONTINUATIONS OF A MULTI YEAR RAMPUP THAT WE'VE SEEN AND HAVE BEEN ABLE TO DO WITH CONGRESSIONAL SUPPORT FOR ALZHEIMER'S DISEASE, FUNDING FOR THAT HAS BASICALLY TRIPLED OVER THE LAST COUPLE YEARS. THE BRAIN INITIATIVE WITH THIS INCREASE IS NOW UP TO $400 MILLION TOTAL. THE ALL OF US RESEARCH PROGRAMS, PART OF PRECISION MEDICINE, UP TO NOW A TOTAL OF 290 MILLION, AS WELL AS ANTIMICROBIAL RESISTANCE, WHICH HAS NEARLY DOUBLED OVER SEVERAL YEARS, AND THE UNIVERSAL FLU VACCINE NOW UP TO $1,200,000,000 TOTAL. DAIRK NOW UP TO $100 MILLION TOTAL. IN TERMS. OPIOID PAIN RESEARCH, WE'VE NOW HAD AND OFFICIALLY ANNOUNCED THE HEEL INITIATIVE -- HEAL INITIATIVE, STANDS FOR HELPING TO END ADDICTION LONG-TERM, YOU'LL BE HEARING MORE ABOUT THAT TOMORROW IN DETAIL, FROM A FUNDING PERSPECTIVE THE $500 MILLION IS SPLIT EQUALLY BETWEEN NIDA AND NINDS BUT WE ALSO WERE GIVEN TRANSFER AUTHORITY SO THAT OTHER INSTITUTES COULD FUND THEIR INITIATIVES OUT OF THAT AMOUNT AND WE HAVE A PLAN NOW TO TRANSFER FUNDS 36 MILLION TOTAL TO THREE OTHER INSTITUTES, NCATS , NICHD AND NIAID FOR PROJECTS THAT ARE PART OF THE HEAL INITIATIVE, AS WELL AS BEING ABLE TO SUPPLEMENT GRANTS THROUGHOUT NIH THAT COULD CONTRIBUTE TO THE HEAL INITIATIVE IN A VA RIGHT OF DIFFERENT WAYS -- IN A VARIETY OF DIFFERENT WAYS. LET ME TOWRN THE 2019 PRESIDENT 'S BUDGET, THIS IS A RATHER COMPLICATED ONE TO EXPLAIN BECAUSE OF THE WAY THE TIMING WENT. WE HAD THE BUDGET, BUDGET CAME OUT ON FEBRUARY 12, THE BIPARTISAN BUDGET ACT CAME OUT ON FEBRUARY 9 JUST A COUPLE DAYS BEFORE SO THERE WASN'T ENOUGH TIME BEFORE THE BUDGET WAS RELEASED TO TAKE INTO ACCOUNT THE EFFECTS OF THOSE HIGHER DISCRETIONARY CAPS. SO BASED ON THE PREVIOUS CAPS, N IH BUDGET WAS ORIGINALLY GOING TO BE A REQUEST OF 25.6 BILLION FOR 2019, WHICH WOULD HAVE BEEN CONSIDERABLY LOWER THAN WHERE WE WERE LAST YEAR, BUT AS A RESULT OF THE HIGHER DISCRETIONARY CAPS , THE ADMINISTRATION DECIDED THAT THEY WERE GOING TO DO MORAL OF A FLAT BUDGET REQUEST FOR 2019, BUT DIDN'T HAVE TIME TO GET THAT INTO THE ORIGINAL BUDGET, SO THEY INCLUDED AT THE TIME OF THE RELEASE WHAT WAS CALLED AN ADDENDUM, WHICH BASICALLY SAID DESPITE WHAT'S IN THE PRINTED BUDGET, WE'RE ACTUALLY REQUESTING 34.8 BILLION FOR NIH. SO YOU COULD SEE IN THE TOP LINE OF THE TABLE, AGAIN AT THE TIME, BECAUSE THEY DIDN'T KNOW THAT WE WOULD EVENTUALLY HAVE OVER 37 BILLION, THE BUDGET WAS BASED ON THE LAST CONTINUING RESOLUTION LEVEL, WHICH WAS AROUND 34, AND SO THE REQUEST WAS SLIGHTLY HIGHER, ABOUT $700 MILLION HIGHER THAN THAT, BUT THAT WAS FOR CONSOLIDATING SOME OTHER PROGRAMS INTO NIH, WHICH I'LL TALK ABOUT IN A MINUTE. THE OTHER THING THAT WAS SIGNIFICANT FOR US IN THE ADDENDUM WAS A SEPARATE DEPARTMENT-WIDE REQUEST FOR AN ADDITIONAL $10 BILLION TO ADDRESS THE OPIOID CRISIS, OF THAT 750 MILLION WAS FOR NIH RESEARCH, THAT WOULD BE OVER A PERIOD OF MULTIPLE YEARS, BUT THAT WAS IN ADDITION TO THE NIH- SPECIFIC REQUEST THAT WE HAD AT THE 34 BILLION LEVEL. SO LET ME TALK A LITTLE BIT ABOUT SOME OF THOSE CONSOLIDATIONS AND SOME OTHER THINGS THAT HAVE CHANGED SINCE THE PREVIOUS BUDGET REQUEST. LAST YEAR THERE WAS A PROPOSAL TO CONSOLIDATE THE AGENCY FOR HEALTHCARE RESEARCH AND QUALITY INTO NIH. THAT PROPOSAL DID NOT GO THROUGH , WAS NOT APPROVED BY CONGRESS BUT WAS REQUESTED AGAIN , AND IN ADDITION THIS YEAR , THERE ARE PROPOSALS TO ADD N TI OSH, NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH, WHICH IS AT CDC, AND WHAT IS CALLED NIDLER OR NATIONAL INSTITUTE ON DISABILITY INDEPENDENT LIVING AND REHABILITATION RESEARCH, WHICH IS AT THE ADMINISTRATION FOR COMMUNITY LIVING BOTH WITHIN HHS , CONSOLIDATION OF THOSE AGENCIES INTO NIH FOR 2019 IN THIS PRESIDENT'S BUDGET PROPOSAL THERE WAS ANOTHER PROPOSAL LAST YEAR AND PART OF THAT CONSOLIDATION AND REORGANIZATION PROPOSAL THAT WOULD HAVE TERMINATED THE FOAL GARR TI INTERNATIONAL -- THE FOGARTY INTERNATIONAL CENTER, THAT IS NO LONGER PROPOSED, SO CONGRESS DID NOT ACCEPT THAT LAST YEAR AND THE ADMINISTRATION DID NOT PROPOSE THAT FOR 2019, SO THAT IS CHANGED. AND THE OTHER CHANGE THAT WAS AN ISSUE LAST YEAR YOU MAY RECALL, THERE HAD BEEN A PROPOSAL TO REDUCE INDIRECT COST PAYMENTS FOR EXTRAMURAL RESEARCH, CONGRESS DID NOT APPROVE THAT. IN FACT, PUT IN PROVISIONS TO BLOCK THAT IN THE CONTINUING RESOLUTIONS AND APPROPRIATIONS BILL, SO THIS BUDGET DOES NOT PROPOSE CHANGES TO INDIRECT COST POLICIES. WITHIN THE BUDGET, EVEN THOUGH IT'S MORE LIKE 2017 THAN 2018, THERE ARE SOME TARGETED INCREASES. THE FIRST FEW FOR THE 21ST CENTURY CURES FUNDING, THOSE WERE STATUTORY PLANNED INCREASES , SO WHEN THE 21ST CENTURY CURES ACT PASSED, IT HAD A MULTIYEAR PROJECTION OF FUNDING LEVELS, SO THESE INCREASES FOR THE CANCER MOONSHOT FOR THE ALL OF US RESEARCH EXPRAM FOR BRAIN ARE AT THE LEVELS IN THE 21ST CENTURY CURES ACT, AND IN ADDITION TO THAT, WE HAD PROPOSALS FOR THE NEXT GENERATION RESEARCHERS INITIATIVE, WHICH YOU'LL BE HEARING MORE ABOUT, OPIOIDS A PART OF NOW WHAT IS THE HEAL INITIATIVE, PUBLIC/PRIVATE PARTNERSHIP, THAT 1,200,000,000 WOULD BE IN ADDITION TO THE 750 THAT WAS PROPOSED FOR NIH-WIDE INITIATIVE, SO 850 TOTAL FOR OPIOIDS AS WELL AS INCREASES FOR BUILDING OF FACILITIES, PRIZE COMPETITIONS AND DATA SCIENCE. SO WITH THAT, LET ME STOP AND TAKE QUESTIONS. >> Francis Collins, MD: MAYBE WE SHOULD HAVE ADRIAN PRESENT AND THEN BOTH OF YOU COULD TAKE QUESTIONS TOGETHER BECAUSE THERE'S SOME OVERLAP HERE BETWEEN THE BUDGET-ISH UCH AND THE LEGISLATIVE ISSUE. ADRIAN HALLACK AND I SHOULD WELCOME ROY WILSON WHO I KNOW YOU HAD A REASON TO BE A LITTLE LATE, BUT I'M GLAD YOU JOINED US >> GOOD MORNING. SO AS FRANCIS MENTIONED, THERE IS A LOT HAPPENING, AND IT'S HARD WHEN WE LOOK BACK ON OUR LAST MEETING AT DECEMBER 15 TO REALLY ENCAPSULATE ALL THAT'S HAPPENED IN POLITICS. SO I'LL JUST GIVE ONE SENSE OF HOW FAR WE HAVE COME, THIS $3 BILLION NEWS. SIX MONTHS AGO, THIS IS WHERE WE WERE. WE ACTUALLY HAD A GOVERNMENT SHULTDOWN. SO THAT'S HOW WE STARTED THIS YEAR, IT HAS GONE MUCH BETTER SINCE THEN. IT TOOK ABOUT A YEAR TO GET A TWO-YEAR BUDGET DEAL AGREED TO. WE TALKED ABOUT WHAT THE STAKES WERE IN DECEMBER, BUT JUST BEFORE I TELL YOU WHAT'S IN T I WANT TO TILL A COUPLE THINGS ABOUT IT, AND THAT IS FIRST WHAT WE SAW IN THIS BUDGET AGREEMENT WAS INCREDIBLE. THEY WERE HAVING FIGHTS ABOUT THE CHIP EXTENSION, THEY WERE HAVING FIGHTS ABOUT THE MANDATORY BUDGET CAPS, THEY WERE HAVING FIETSZ ABOUT THE FARM BILL, THEY TOOK A WHOLE LOT OF ARGUMENTS BUNDLED IT INTO ONE BIG PACKAGE. SO WHAT YOU SEE IS THAT ALL OF THESE VARIOUS POLICY FIGHTS AND THE BUDGET FIGHTS ARE COMING TOGETHER. IT TAKES A WHILE TO GET THERE, BUT WHEN THEY GET THERE, IT'S A BIG DEAL. THE AUSTERITY BUDGET CAPS THAT THE TEA IT PARTY BROUGHT INTO THEM IN 2011 HAS ONLY GONE INTO EFFECT ONCE, 2013, THAT WAS THE SEQUESTER YEAR, SO WE'VE SEEN THESE TWO-YEAR DEALS, CONGRESS IS DEALING WITH THIS TWO YEARS AT A TIME AND THIS YEAR WAS NO EXCEPTION. THE BUDGET CAPS ACTUALLY EXPIRE IN 2022. SO HOPEFULLY WE CAN EXPECT ONE MORE TWO-YEAR DEAL. WE'RE GOING TO NEED ONE MORE TWO -YEAR DEAL. THIS IS WHAT THE TWO-YEAR BUDGET AGREEMENT DID. SO ON THE FAR LEFT YOU SEE FY17, THAT'S WHERE WE WERE AT 540, AND ORIGINALLY WE WERE SUPPOSED TO GO DOWN TO 516. THESE ARE NONDEFENSE DISCRETIONARY. YOU CAN SEE WHERE OUR $3 BILLION COMES FROM. IT WAS QUITE A SURPRISE TO GET $3 BILLION. OUR APPROPRIATORS HAVE CAUTIONED US NOT TO EXPECT IT AGAIN, AND YOU CAN SEE WHY. THIS WAS A UNIQUE OPPORTUNITY FOR THEM TO REALLY FOCUS SOME INVESTMENT, AND THEY DID. YOU CAN ALSO SEE WHY NOT EVERYBODY ON THE HILL WAS HAPPY WITH THIS DEAL. THESE WERE SOME LARGE INCREASES. THIS YEAR THERE'S A LITTLE MORE MODEST INCREASE, BUT THERE IS SOME ROOM FOR APPROPRIATORS TO MAKE SOME INVESTMENTS, AND WE ARE CERTAINLY ENCOURAGING THEM TO LOOK OUR DIRECTION. THE FY18 OMNIBUS AS NEIL DETAILED TO YOU HAD A $3 BILLION INCREASE. THE THING I'LL GET YOU TO NOTICE ABOUT IT IS THAT TYPICALLY THESE BIG OMNIBUS BILLS HAVE OVERWHELMING MINORITIES. THIS HAD DEFENSE IN IT -- MAJORITY JOR TIES. THIS HAD DEFENSE IN IT, HOMELAND SECURITY, THERE'S GENERALLY SOMETHING FOR EVERYBODY IN AN OMNIBUS. IT DIDN'T WIN BY THE BIG MARGINS YOU WOULD EXPECT IT TO WIN BY, SO THERE IS STILL SOME BUDGET AND SPENDING DISCORD GOING ON, THAT MIGHT BE THE POLITEST WAY TO SAY WHAT'S GOING ON. IT TOOK A YEAR TO GET THE BUDGET CAPS. IT TOOK SIX WEEKS TO AGREE TO ALL THE BUDGET AND POLICY FIGHTS GOVERNMENT-WIDE IN THIS BILL. ONCE THEY HAD THE TOP LINE NUMBER, THEY FLEW TO AN AGREEMENT BUT IT ALSO MEANS THAT THIS BILL PASSED IN MARCH. TIM CLI THE BUDGET SEASON FOR THIS COMING YEAR WOULD HAVE STARTED AT THE BEGINNING OF FEBRUARIES, SO AT THE END OF MARCH THEY WERE STILL DEALING WITH THE PRIOR YEAR. THEY'VE SET A SET A GOAL OF GETTING ALL THEIR BILLS WRITTEN AND OUT OF CAN COMMITTEE BY JULY 31ST, ALL THE BILLS ON THE HOUSE AND SENATE DEALING WITH ABSOLUTELY EVERYTHING IN GOVERNMENT AM IT'S A VERY COMPRESSED, VERY AMBITIOUS AGENDA. IN THE MIDDLE OF THAT THEY HAVE SOME HEARINGS. WE HAD THREE HEARINGS, ONE ON OPIOIDS AND TWO ON APPROPRIATION S, WHICH CAN BE ABOUT ANYTHING. I THREW UP SOME OF THE QUESTIONS THAT WE GOT AT MANY OF OUR HEARINGS. THE QUESTION WE GOT OVER AND OVER AND OVER AGAIN IS HOW ARE YOU GOING TO SPEND THAT $500 MILLION IN OPIOIDS AND PAIN FUNDING? WE GOT A LOT OF QUESTIONS ABOUT PEDIATRIC CANCERRING UNIVERSAL FLU VACCINE, THERE'S SOME EXCITEMENT AROUND THAT IS CORRECT AS YOU HAVE PROBABLY HEARD, ALZHEIMER'S IS PER SIS STERNGHTS OUR DOWN'S SYNDROME RESEARCH PLAN, WE GET A WIDE RANGE OF QUESTIONS BUT THE HILL IS REALLY FOCUSED ON OPIOIDS, SO THEY WERE VERY EXCITED WHEN WE MADE OUR HEAL INITIATIVE, WE GOT SOME GREAT RETWEETS, WE GOT SOME GREAT FLOOR STATEMENTS, EVERYBODY IS REALLY ENGAGED AND FOCUSED ON THIS INITIATIVE. DR. COLLINS SHOWED YOU ALL OF THE MEMBERS WE ARE ABLE TO LURE UP HERE TO BETHESDA TO SEAL OUR CLINICAL CENTER, BUT WE CAN'T ALWAYS GET PEOPLE TO COME HERE , SO SOMETIMES WE HAVE TO GO ON THE ROAD TO FIND THEM. THIS SPRING DR. COLLINS WENT TO SEE MR. YOHO IN FLORIDA, THIS IS AT AN INCUBATOR, SPOKE AT THE UNIVERSITY OF FLORIDA, THIS IS A WAY FOR US TO CONNECT WITH MEMBERS IN THEIR HOME STATES AND MAKE THE POINT ABOUT HOW NIH REALLY IMPACTS THEIR DISTRICT. THAT SAME TRIP IN THE GUISE OF NO VENUE IS TOO SMALL, WE WENT TO BENTONVILLE. >> Dr. Arkin: WITH MR. WOMACK A MEMBER OF OUR APPROPRIATIONS SUBCOMMITTEE AND BRAND-NEW CHAIFORT HOUSES BUDGET COMMITTEE , SPOKE TO A HIGH SCHOOL AND EVEN WENT TO THE KIWANIS YOUTH EXCELLENCE AWARDS, WHICH WAS A REALLY ACTUALLY GREAT EVENT. IN ADDITION, WE WENT TO SEE HOWE ROJ ERPZ AT HIS ANNUAL RX SUMMIT WHY DO WE GO -- HOWE ROGERS IS 45 MINUTES AWAY. WHY DO WE ALWAYS GO TO ATLANTA EVERY YEAR TO SEE HIM? IT'S BECAUSE HOWE ROGERS BRINGS WITH HIM LOTS OF OTHER MEMBERS, SO IN THAT ONE EVENT WE WERE ABLE TO MEET A LOT OF DIFFERENT MEMBERS AND TALK ABOUT ISSUES OF INTEREST TO THEM. THAT SHOWS YOU THERE'S A LOT OF FOLKS, WHEN A SENATOR FROM NEW HAMPSHIRE GOES TO ATLANTA TO TALK ABOUT OPIOIDS, YOU CAN SEE THAT THERE'S A FOCUS AND THERE'S AN OPPORTUNITY TO REALLY COME TOGETHER ACROSS THE POLITICAL SPECTRUM. BUT I DON'T WANT TO LEAVE YOU WITH THE THOUGHT THAT DR. COLLINS IS, ALTHOUGH HE IS OUR PREMIER AND OUR HOME RUN HIT TER, HE IS NOT THE ONLY PERSON AT NIH WHO TALKS TO CONGRESS. SO I WANT TO LET YOU KNOW THAT WE AS AN NIH ARE INCREDIBLY FORTUNATE TO HAVE 27 INSTITUTE AND CENTER DIRECTORS WHO ARE VERY TALENTED, VERY ENGAGING LEADERS IN THEIR FIELD AND WE HAVE SCIENTISTS ACROSS THIS CAMPUS WHO EVERY DAY ARE GOING DOWN TO THE HILL AND SPEAKING ABOUT TOPICS OF INTEREST. SO THIS IS LEGISLATIVE AFFAIRS IS A TEAM SPORT HERE AT NIH. SO THAT AMBITIOUS AGENDA FROM THE END OF NOOR THE END OF -- END OF MARCH TO THE END OF JULY, OUR FUNDING BILLS ARE SCHEDULED FOR COMMITTEE VOTES TOMORROW IN THE HOUSE SUBCOMMITTEE, NEXT WEDNESDAY HOUSE FULL COMMITTEE AND THEN THE FOLLOWING WEEK TUESDAY AND THURSDAY SUBCOMMITTEE AND FULL COMMITTEE. SO YOU'RE GOING TO HEAR A LOT OF TALK ABOUT NIH FUNDING AND NIH FUNDING PROPOSALS. IT MIGHT GET A LITTLE CONFUSING BECAUSE THE HOUSE AND SENATE REALLY ARE OVERLAPPING, BUT FORTUNATELY AS DR. COLLINS SAID, I NEVER KNOW WHEN MY SLIDES ARE SET AND AT 9:23 THIS MORNING AS HE WAS TALKING, THEY CHANGED. SO THE BILL FOR THE HOUSE WAS RELEASED THIS MORNING AT 9:23 A.M. THE HOUSE TOTAL FOR NIH IS A $1.25 BILLION INCREASE. YOU HEARD IT HERE FIRST. INCLUDED IN THAT IS A $400 MILLION INCREASE IN ALZHEIMER'S, A $30 MILLION INCREASE IN THE UNIVERSAL FLU VACCINE PROGRAM. THE ALL OF US PROGRAM HAS $147 MILLION INCREASE, WHICH IS INCREDIBLY NEEDED FOR THE WORK THEY ARE DOING AS WE RAMP UP AND ENROLL ALL OF THESE PEOPLE. WE GOT AN INCREASE IN THE CARB PROGRAM, THIS IS A CONSISTENT INTEREST OF CAPITOL HILL, $29 MILLION INCREASE FOR BRAIN, $15 MILLION INCREASE FOR IDEA, AND ONE OF THE THINGS WE ARE REALLY STARTING TO TALK ABOUT AND I PREDICT YOU'LL HEAR MORE ABOUT IN THE COMING YEARS IS OUR PHYSICAL FACILITIES HERE AT NIH. SO THERE'S A $70 MILLION INCREASE IN OUR PHYSICAL FACILITIES, AND YOU'LL HEAR MORE ABOUT THOSE INITIATIVES AS WE GO ALONG. SO I'M CONTINUING TO READ THAT BILL LANGUAGE RIGHT OVER THERE, IF YOU SEE MY HEAD BURIED, IT'S NOT THAT I'M NOT INTERESTED. SO I'LL LET YOU KNOW ANY DETAILS I UNCOVER AS THEY COME TO MIND. THERE ARE ALSO TWO POLICY ISSUES MOVING THAT I WANT YOU ALL TO BE AWARE OF. THE FIRST IS THE OTHER TRANSACTIONS AUTHORITY EXPANSION AND THE SECOND IS THE FACA AMENDMENTS BILL. YOU ARE A FEDERAL ADVISORY COMMITTEE, SO THAT BILL PARTICULARLY PERTAINS TO THE WAY YOU DO THIS JOB. OTHER TRANSACTIONS AUTHORITY. IT BASICALLY JUST SAYS THAT NIH CAN MAKE AWARDS THAT AREN'T A GRANT OR A CONTRACT. WE CAN MAKE OTHER AWARDS. IT GIVERS US SOME FLEXIBILITY IN THE WAYS WE INTERACT WITH OUR AWARDEES. ON JUNE 12 THE HOUSE APPROVED A BILL THAT EXPANDS OUR AUTHORITY TO HIGH IMPACT CUTTING EDGE RESEARCH, YOU CAN READ THE LANGUAGE, AND WORK THAT WE'RE TRYING TO DO TO RESPOND TO A PUBLIC HEALTH THREAT. THIS ALLOWS US TO MOVE A LOT FASTER AND ALSO IDENTIFY PARTNERS THAT WOULD BE REALLY IDEAL PARTNERS FOR UNIQUE NEEDS. IT'S SOMETHING THAT WE'VE USED TO GREAT SUCCESS IN THE ALL OF US PROGRAM AND ALSO IN THE COMMON FUND, NCATS HAS USED IT TO SOME DEGREE I BELIEVE IN CANN THE SENATE HEALTH COMMITTEE APPROVED IDENTICAL LANGUAGE IN APRIL, SO NOW THAT THIS IS IN THE SENATE, I DON'T EXPECT THERE TO BE ANY PROBLEM, IT'S JUST A QUESTION OF TIMING. SO THAT WILL APPLY TO ALL OF THE FUNDS AT NIH. THE FACA AMENDMENTS ACT, THIS IS A BILL THAT PASSED THE HOUSE WITH A SPATE OF PRO TRANSPARENCY BILLS EARLY IN THEIR SESSION, IT HAS NOW MOVED IN THE SENATE PAST COMMITTEE WITH NO CHANGES. IT HAS A NUMBER OF PROVISIONS THAT ARE OF CONCERN TO THE DEPARTMENT OF HEALTH AND HUMAN SERVICES AND TO NIH SPECIFICALLY IT WOULD REQUIRE ALL OF OUR PEER REVIEWERS TO BE SPECIAL GOVERNMENT EMPLOYEES. YOU ALL HAVE FILLED OUT THE PAPERWORK TO BE SPECIAL GOVERNMENT EMPLOYEES, YOU CAN IMAGINE, TOLD IT WILL TAKE A LITTLE OVER A YEAR FOR US TO GET OUR PEER REVIEWERS UP TO SPEED AND ABLE TO DO THE JOB WE ASK OF THEM. THE SUBCOMMITTEES OF ADVISORY COMMITTEES WILL BECOME FACA COMMITTEES, SO THOSE OF YOU WHO HAVE LED OR PARTICIPATE IN WORKING GROUPS OF THIS ACD, IT'S A MUCH DIFFERENT BALL GAME IF THIS BILL PASSES. PUBLIC COMMENT ON ANY NOMINATIONS, SO THERE WOULD BE A PUBLIC COMMENT PERIOD, ENJOY THAT. DE FACTO MEMBERSHIP, SO MY ANY OF YOU WHO REGULARLY COME TO OUR MEETING, WE DON'T KNOW WHAT THAT WOULD MEAN FOR QUORUMS OR FOR VOTING PURPOSES. PUBLICLY POST ANY FINANCIAL WAIVERS THAT YOU ALL HAVE. REQUIRE PUBLIC POSTING OF ALL MEETING MATERIALS AND IT'S NOT CLEAR YET WHETHER THAT APPLIES TO OUR CLOSED SESSION, BUT IT CERTAINLY COULD, AND THAT MORE IMPACTS OUR IC ADVISORY COMMITTEES WHERE THEY ARE ACTUALLY APPROVING GRANT APPLICATIONS. AND ALSO PUBLIC DISCLOSURE OF WHO IS NOMINATING PEOPLE. SO IT'S CLEAR THAT THIS IS A TRANSPARENCY EFFORT THAT'S GEARED AT CERTAIN ABUSES. WE ARE MAKING THE CASE TO THE HILL THAT IT DOESN'T REALLY FIT, THE WAY WE USE ADVISORY COMMITTEES IS A LITTLE BIT DIFFERENT THAN HOW MANY AGENCIES USE THEM. SO WE ARE TALKING TO THE HILL ABOUT T WE HAVE A COUPLE OF MEMBERS WHO ARE ENGAGING ON OUR BEHALF, BUT I WANTED TO MAKE SURE YOU ALL KNEW ABOUT IT BECAUSE THIS BILL IS MOVING FAST ONE VOLT ON A SENATE FLOOR MEANS THAT IT WOULD GO TO THE PRESIDENT'S DESK FOR SIGNATURE, SO THERE COULD BE SOME MAJOR CHANGES HAPPENING IN THE FUTURE. A LITTLE BIT OF A FORECAST, DR. COLLINS ALWAYS LIKES IT WHEN I FORECAST AND IT ALWAYS MAKES ME A LITTLE NAUSEOUS WHEN I TRY TO DO IT. BUT WE ARE IN THE MIDST OF THE SEASON FOR DRAMA. WE ARE IN AN ELECTION YEAR. THERE ARE PRIMARIES, AS YOU ALL PROBABLY KNOW AS CITIZENS OF THE UNITED STATES, DURING A PRIMARY WHAT WE SEE IS THE CANDIDATES DIVERGE BECAUSE THEY'RE TRYING TO APPEAL TO THE EXTREMES, THE PEOPLE WHO VOTE IN PRIMARIES. AND THEN ONCE THEY GET INTO THE GENERAL ELECTION, THEY TEND TO COME BACK TO THE CENTER. THERE'S A VERY LONG DIVIDE BETWEEN THE PRIMARIES. WE HAVE PRIMARIES GOING INTO SEPTEMBER. SO WE WILL SEE A LOT OF THIS ACTIVITY. IT WILL IMPACT THE FLOOR DEBATE. WHAT PEOPLE WANT TO TALK ABOUT ON THE FLOOR DEPENDS ENTIRELY ON -- NOT EN TIRELY, THAT'S NOT FAIR. THERE'S A GREAT INTEREST OF WHAT IS THE ELECTORAL LANDSCAPE WHEN THEY'RE TAKING VOTES. IN SEPTEMBER WE ALSO HAVE TO THINK ABOUT A SHUTDOWN, WE HAVE TO THINK ABOUT HOW FAR AND WHEN AND AT WHAT LEVEL THEY'RE GOING TO EXTEND FUNDING, BECAUSE I DON'T ANTICIPATE THEY WILL FINISH ALL TWELVE SPENDING BILLS BEFORE SEPTEMBER 30TH. POLITICS WILL COME TO PLAY. GO TFER IN OCTOBER, THAT IS GET OUT TO VOTE, THAT MEANS THAT'S MY PERSONAL HEADS UP TO YOU ALL AS A NEIGHBOR THAT THAT'S WHEN YOU GET THE DOOR KNOCKS, THAT'S WHEN PEOPLE WILL BE CALLING YOU CONSTANTLY. SO IN OCTOBER MAKE YOUR PLANS ABOUT YOUR TELEVISION WATCHING. NOVEMBER, EARLY NOVEMBER IS THE GENERAL ELECTION. DEPENDING ON WHAT HAPPENS IN THAT GENERAL ELECTION, IF ONE OF THE BODIES FLIPS, THAT WILL -- THEY WILL HAVE A LOT TO SAY ABOUT WHETHER THEY WANT TO CONCLUDE THEIR BUSINESS IN THE LAME DUCK SESSION OR WHETHER THEY WANT TO PUSH IT OFF TO JANUARY WHEN THE NEW MEMBERS CAN VOTE ON IT. SO THAT'S MORE AN EXCUSE FOR WHY I CAN'T TELL WHAT YOU CONGRESS IS GOING TO DO THIS SUMMER AND THIS FALL THAN A PREDICTION, BUT HOPEFULLY IT WILL HELP YOU AS YOU WATCH CONGRESS FROM HOME OF THE. WILL THE NEXT CONGRESS LOOK ANY DIFFERENT? WELL, WHAT'S INTERESTING ABOUT POLITICS AT THIS POINT, ONE THING THAT I FIND INTERESTING IS THAT ADVOCACY GROUPS ARE NO LONGER TRYING TO GET THEIR QUESTIONS IN FRONT OF POTENTIAL CANDIDATES. THEY'RE NOT TRYING TO GET COMMITMENTS ON THIS ISSUE OR THAT ISSUE FROM CANDIDATES. THE STRATEGY HAS CHANGED. ADVOCACY GROUPS ARE ACTUALLY FIELDING THEIR OWN CANDIDATES THAT THEY BELIEVE WILL HAVE A WORLD VIEW MORE LIKE THEIR OWN T-475 WOMEN ARE RUNNING, RIGHT NOW 120 WOMEN HAVE PEAMSED THE PRIMARY, THEY ARE GOING TO BE ON THE GENERAL ELECTION BALLOT. IN THE SENATE 23 WOMEN SERVE, 53 WOMEN ARE RUNNING, FIVE HAVE PASSED. KEEP IN MINDS THE WOMEN WHO PASS PRIMARIES SOME OF THEM ARE INCUMBENTS SO THESE WILL NOT JUST ADD TO THE TOTAL. BUT WE MAY SEE A DIFFERENCE THERE. VETERANS. THERE ARE 79 VETERANS SERVE EPG IN THE HOUSES. THERE ARE 200 RUNNING FOR THE HOUSE. AGAIN, IT'S NOT -- YOU CAN'T ASSUME THERE'S ONE PER DISTRICT. SOME OF THEM ARE RUNNING AGAINST ONE ANOTHER, SO WE'LL SEE WHAT THAT LOOKS LIKE AT THE END OF THE DAY, BUT IT IS AN INTEREST GROUP THAT'S REALLY PUSHING. AND THE HEALTH AND SCIENCE SECTOR IS NOT TO BE LEFT BEHIND, SO THERE HAS BEEN A LOT OF PUSH FROM SCIENTIFIC SOCIETIES AND MEDICAL SOCIETIES TO GET PRACTITIONERS MORE INTO ELECTED OFFICE. SO WILL THAT CHANGE THE AGENDA FOR CONGRESS NEXT SESSION? I DON'T KNOW. BUTS AN INTERESTING THING TO WATCH FOR AS OCCUPATIONS, PREVIOUS OCCUPATIONS OF MEMBERS BECOME EQUALLY IMPORTANT TO IDEOLOGY OR PROFESSED POSITIONS ON SPECIFIC ISSUES. THANK YOU. >> Francis Collins, MD: WELL, THANKS, DISMEEM ADRIAN FOR AN INTERESTING ROMP THROUGH ALL OF THE UNCERTAINTIES OF WHERE WE ARE WITH LEGISLATION AND BUDGET. QUECHES FROM THE ACD? YES K JOSE. >> ONE ISSUE THAT AFFECTS THE QUESTION OF SCIENCE IN THIS INDUSTRY IS THE ABILITY TO DRAW ON TALENT FROM MANY PARTS OF THE WORLD. WHAT IS THE STATUS OF IMMIGRATION IN TERMS OF THE COURT DECISIONS AND LEGISLATION TO ALLOW THE FREE EXCHANGE OF IDEAS AND PEOPLE? >> SO ON IMMIGRATION WHERE WE ARE RIGHT NOW, LIKE EVERY WE TALK ABOUT IN THE HOUSE, THERE IS A LARGE CONSERVATIVE CONTINGENT AND THERE IS A LARGE MODERATE CONTINGENT IN THE REPUBLICAN PARTY. MODERATE PARTY IS WORKING ON A DISCHARGE POSITION WHERE THEY CAN FORCE THEIR LEADERSHIP TO VOTE TO IT. THE CONSERVATIVES HAVE THEIR OWN PROPOSAL THAT THEY WANT TO VOTE ON, SO RIGHT NOW THE LEADERSHIP IS STRUGGLING TO COME UP WITH A COMPROMISE. I UNDERSTAND THAT THERE IS BILL LANGUAGE THAT THEY ARE FLOATING, THEY'RE TRYING DECISEPARATELY TO COME UP WITH SOMETHING THAT THE ENTIRE CAUCUS CAN SUPPORT. WE'RE GOING TO HAVE TO SEE. BUT I DO EXPECT IT TO BE AN ISSUE IN THE ELECTION. >> BUT IN TERMS OF THE TARGETING OF SPECIFIC COUNTRIES, WHERE DO WE STAND ON THAT? >> THERE ARE SOME EFFORTS TO THINK ABOUT HOW COUNTRIES ARE TRANSFERRING AND TO WHAT END THEY ARE TRANSFERRING KNOWLEDGE SO I DO KNOW THAT THERE ARE CERTAIN -- WE HAVE GOTTEN QUESTIONS AT HEARINGS ABOUT CERTAIN INSTITUTIONS AND CERTAIN COUNTRIES AND THEIR PRACTICES WITH KNOWLEDGE AND WITH DATA, SO I KNOW THAT IT'S EMERGING AS AN ISSUE IN SCIENCE. I CAN'T SAY WRITS GOING TO GO YET. I CAN'T SAY WHERE IT'S GOING TO GO YET. >> Francis Collins, MD: ROY? >> WE GOT THROUGH THE INDIRECT COSTS ISSUE, BUT AT THE SAME TIME WHEN THOSE DISCUSSIONS WERE GOING ON, THIS THREAT REALLY DID FEEL REAL AT THE TIME, AND MANY OF US IN THE UNIVERSITY COMMUNITY AND OTHER VENUES WROTE OP-EDS AND WROTE LETTERS AND SO FORTH, BUT ONE OF THE CHALLENGES THAT WE FOUND, IT WAS VERY DIFFICULT ON EXPLAIN WHAT INDIRECT COSTS WAS, AND EVEN MANUFACTURE OUR FACULTY DIDN'T UNDERSTAND WHAT INDIRECT COSTS WAS AND THOUGHT IT WAS SOME KIND OF SLUSH FUND THAT WOULD GO BACK TO THEM. SO, YOU KNOW, MANY OF US STARTED ADVOCATING FOR USING THE TERM FACILITIES ADMINISTRATION, F AND A, AND I THINK THAT THAT'S SOMETHING WE SHOULD CONTINUE TO REMEMBER AND CONTINUE TO USE WHENEVER WE COMMUNICATE BECAUSE THERE MAY BE A THREAT AGAIN COMING UP AND WE NEED TO BE REALLY PREPARED FOR THAT AND BE ABLE TO REALLY VERY CONCISELY EXPLAIN WHAT THESE COSTS ARE USED FOR. >> SO I UNDERSTAND OBVIOUSLY IT'S JUST A NUMBER CURRENTLY IN THE BILL FOR THE HOUSE, THE 1.25 IT SEEMS LIKE THERE WAS A SIGNIFICANT NUMBER IN TERMS OF TARGETED APPROPRIATIONS, FOR THE INNOVATION PROJECT AND SO FORTH. IN TERMS OF SORT OF THE MAGNITUDE OF WHAT'S LEFT, I GUESS THAT WOULD BE MORE LIMITED IN TERMS OF SORT OF BRAWFDLY FOR NIH. HOW MUCH CAN TRANSACTION THORLT OR NOVEL -- AUTHORITY OR NOVEL APPLICATION BE SORT OF USED TO TRY TO BROADLY USE THAT MONEY SORT OF TO FUND THE BEST SCIENCE >> SO JUST BACK TO THE ENVELOPE, I THINK OF THE 1.25 BILLION THERE'S ABOUT 700 THAT'S DEDICATED TO PROJECTS AND THE REST IS APPLIED GENERALLY ACROSS THE INSTITUTES AND CENTERS. IT WILL BE, I BELIEVE, ANY OF THE MONEY INCLUDING THE BASE FUNDS CAN BE USED WITH THIS OTHER IT TRANSACTIONS AUTHORITY. I THINK IT MAKES AWARDS MORE FLEXIBLE, IT MAKES IT POSSIBLY FASTER. I'M TOLD IT MAY COST MORE ADMINISTRATIVELY BECAUSE WE HAVE TO PUT CHEKSZ ON OURSELVES AS WE MAKE THESE -- CHECKS ON OURSELVES AS WE MAKE THESE AWARDS. SO I DON'T KNOW THAT IT MAKES IT CHEAPER FOR US TO MAKE AWARDS BUT IT CERTAINLY DOES MAKE IT FASTER. >> AND KEEP IN MIND THIS IS THE BILL THAT'S BEEN PUT OUT FOR DISCUSSION BUT WILL BE DISCUSSED TOMORROW IN A MARKUP OF THE SUBCOMMITTEE AND THEN THE FULL COMMITTEE THE FOLLOWING WEEK. THE SENATE HAS YET TO REVEAL WHAT THEIR NUMBER MIGHT BE FOR THE LAST COUPLE THREE YEARS. THE SENATE HAS COME UP WELL A SLIGHTLY HIGHER NUMBER THAN THE HOUSE, AND THEY HAVE THEN SAT DOWN TOGETHER AND TRIED TO FIGURE OUTER WHERE THEY WOULD -- FIGURE OUT WHERE THEY WOULD LAND AND THEY'VE GENERALLY LANDED WITH THE SENATE NUMBER. SO I WOULD SAY THIS IS VERY GOOD NEWS TO SEE THAT IN THIS CIRCUMSTANCE OF A LESS EASY TIME THAT THEY'VE HAD IN 19 COMPARED TO 18 FINDING MONEY THAT THE HOUSE LED BY CHAIRMAN COAL WITH RANKING MEMBER DELORO HAVE BEEN ABLE TO COME UP WITH THIS AS THEIR DRAFT THAT'S GOING TO BE MARKED UP TOMORROW. THAT PUTS US ON A VERY POSITIVE TRAJECTORY. MARK? >> FIRST I WANT TO COMMEND YOU, GETTING EXTRA MONEY IN THIS ENVIRONMENT IS PRETTY TOUGH, AND THEY'RE PICKING WINNERS AND LOSERS, THEY'RE NOT JUST GOING ACROSS THE BOARD. SO THE WORK YOU'VE BEEN DOING HAS REALLY PAID OFF, AND I PARTICULARLY COMMEND YOUR WORK IN DISTRICTS AND CON CONSTITUENCIES. VERY FEW PEOPLE HAVE UNDERSTOOD THAT PEOPLE ARE A LOT MORE FOCUSED ON THEIR CONSTITUENCIES THAN GOING TO DISTRICTS OR GOING TO SENATORS OR MEMBERS' EVENT IS HUGE THE BENEFIT, IT'S A BIG SIN K ON YOUR TIME BUT A GREAT INVESTMENT. I THINK HAL ROGERS WANTS, HE'S ONE OF THE SMARTEST AAPPROPRIATE PRI A TORS IN THE WORLD AND EVERYBODY LIRCHES TO HIM. I GUESS THE QUESTION IS LOOKING OUT TO 2020, ALL THE APPROPRIATORS I'M SPEAKING WITH ON THE MAIN COMMITTEE AND THE COMMITTEES I DEAL WITH, 2020 SCARES THEM, YOU KNOW, THE CAPS ARE STILL THERE, THERE ISN'T THE SAME KIND OF CONSENT ON CAPS THAT THERE WAS BECAUSE OF THE TAX CUT, NO ONE KNOWS WHAT REVENUES ARE GOING TO BE AND HOW WIDE THAT GAP IS GOING TO BE, SO I DON'T KNOW HOW YOU'RE THINKING ABOUT 2020. I MEAN ALSO, I'M NOT SEEING THE TACKING BACK TOWARDS MODERATION IN GENERALS THAT WE USED TO SEE. IF ANYTHING SHES IT SEEMS PEOPLE GO TO THE RAILS AND STAY ON THE RAILS BECAUSE THEY'RE TRYING TO GET THEIR VOTERS OUT AND WITH 2020 BEING ANOTHER ELECTION YEAR , IT COULD BE PRETTY ROUGH. SO I DON'T KNOW WHAT YOU'RE THINKING, YOUR SCENARIO PLANNING MIGHT BE TOO EARLY, BUT JUST YOUR SENSE OF THAT BECAUSE 2020 SCARES ME A LOT ACROSS THE BOARD. >> Francis Collins, MD: I THINK WE ARE ALSO QUITE CONCERNED ABOUT HOW THAT WILL SWHAIP OUT BECAUSE OF THE NEED FOR ANOTHER BUDGET AGREEMENT AND LESS CONFIDENCE ABOUT HOW THAT MAY PLAY. I DON'T KNOW ADRIAN IF YOU WANT TO LOOK IN YOUR CRYSTAL BALL OR WHETHER IT'S JUST TOO CLOW CLOUDY. >> I WOULD SAY AS A FORMER APPROPRIATION STAFFER, LONG TIME APPROPRIATION, APPROPRIATORS LIVE AND DIE ONE AT A TIME. I THINK THEY'RE REALLY FOCUSED ON GETTING THROUGH THIS CYCLE. THE SHIFTS, YOU KNOW, WE COULD SEE A REALLY BIG WAVE ELECTION AND IT COULD CHANGE A LOT OF THINGS. I DON'T KNOW WHERE THE ADMINISTRATION IS GOING TO BE EVEN ON THEIR PROPOSAL IN TERMS OF THLZ YEAR THEY WERE SPLIT ON WHETHER THEY SHOULD EVEN USE THE MONEY ON THE CAPS. I THINK WE HAVE A LOFLT TALKING TOLD WITHIN THE ADMINISTRATION ABOUT WHERE THE ADMINISTRATION WANTS TO BE. I DO THINK THE HOUSE MODERATES ARE MUCH MORE EMBOLDEN, WATCHING THEM IN THIS IMMIGRATION DEBATE HAS BEEN FASCINATING, THEY'RE GETTING MUCH MORE ORGANIZED AND PROACTIVE IN THEIR MESSAGING, SO I THINK A LOT OF 2020 DEPENDS ON THIS ELECTION, WHERE DO THE AMERICAN PEOPLE WANT US TO GO. >> NED, SLIDE ON HRQ AND SOME OTHER INSTITUTES GETTING FOLDED ED INTO NIH. I'M CURIOUS, IS THAT JUST AN ADMINISTRATIVE SHIFT OR IS THERE LIKE A -- DO THESE BECOME IC'S OR WHAT'S THE STRUCTURE OR PLAN THERE? >> NEIL CAN TELL YOU WHAT HAS BEEN PROPOSED. >> THE PROPOSAL IS THAT EACH THEM WOULD BECOME ANOTHER INSTITUTE. ARE. >> ANY OTHER QUESTIONS? THAWRKS ADRIAN, THANK YOU -- THANK YOU, ADRIAN, THANK YOU, NEIL. WE ARE JUST ABOUT READY FOR A BREAK. IN FACT, WE ARE READY FOR A BREAK. SO IF WE COULD TAKE 8 MINUTES AND THEN COME BACK AT 11:00, I SEE NED SHARPLESS HAS ARRIVED AND HE'S GOING TO TELL US SOME PRETTY COOL STUFF ABOUT CANCER RESEARCH. SO PLEASE RETURN AT 11:00. >> Francis Collins, MD: WELCOME BACK, EVERYBODY. WE ARE FORT MATT AT MOST OF THESE ACD MEETINGS TO HAVE TIME TO INVITE AN INSTITUTE DIRECTOR TO COME AND TALK ABOUT THE SCIENCE THEY'RE OVERSEEING AND TODAY WE ARE FORTUNATE TO HAVE THE 15TH DIRECTOR OF THE NATIONAL CANCER INSTITUTE WHO WAS SWORN IN ON OCTOBER 17TH AND THAT IS NED SHARPLESS WHO CAME TO US FROM A PREVIOUS POSITION AS THE DIRECTOR OF THE UNC LINE BERGER COMPREHENSIVE CANCER CENTER, HE HAS A DISTINGUISHED SCIENTIFIC CAREER RECOGNIZED BY VARIOUS IMPORTANT THINGS SUCH AS BEING A MEMBER OF THE AAP AND THE ASCI, HE'S AUTHORED MORE THAN 150 PAPERS HIMSELF, WELL-KNOWN FOR THE WORK HE'S DONE ON P16 AND MANY OTHER THINGS, WE ARE FORTUNATE AND DELIGHTED THAT HE AGREED TO COME ON AND TAKE ON THIS REMARKABLE ROLE DIRECTING THE LARGEST OF AWFL THE 27 INSTITUTES AND CENTERS. NCI AND IT'S BEEN A REAL DELIGHT HAVING HIM ON BOARD NOW FOR THE LAST NINE MONTHS OR SODS, JOIN ING ALL THE OTHER INSTITUTE DIRECTORS AROUND THE TABLE WITH REALLY WONDERFUL INNOVATIVE AND VISIONARY ADVICE. SO NED, IT'S GREAT TO HAVE YOU HERE AND I'M SURELY ACD WOULD LOVE TO HEAR FROM YOU. >> THANK YOU FOR THE OPPORTUNITY TO COME TODAY. I'M REALLY I KNOW WORK OF THIS BODY IS VERY IMPORTANT AND I'M GLAD TO SAY A FEW WORDS ABOUT THE CANCER INSTITUTE AND ALSO LEAVE SOME TIME FOR QUESTIONS SO I HOPE IF THERE ARE THINGS ABOUT THE NCI YOU'VE ALWAYS WANTED TO KNOW, TO THE EXTENT THAT I'LL BE ABLE TO ANSWER THEM, I WILL TRY. SO AS FRANCIS MENTIONED, I'VE BEEN HERE A BRIEF TIME, GOING ON NINE MONTHS NOW, THIS IS MY WIFE AND I GETTING SWORN IN BY ERIC H ARGAN BACK IN OCTOBER. SO I'M STILL AT A STAGE WHERE I THINK YOU HAVE TO BE AN IC DIRECTOR MORE THAN A YEAR BEFORE I FEEL LIKE YOU UNDERSTAND THE N IH, SO I'M STILL AT MEETINGS WHERE I TRYING TO FIGURE OUT WHAT THE ACRONYMS STAND FOR. THE C IS PROBABLY FOR CANCER BUT I'M NOT SURE. [LAUGHTER] SOME OF THESE COMMITTEES. SO FAR, SO GOOD. S I ENJOY THE JOB, GET TO WORK WITH GREAT PEOPLE AND THE PERSONNEL AT NCI IN PARTICULAR HAS BEEN WHAT I WOULD SAY THE MOST PLEASANT SURPRISE. IT'S COME PRIEMENTZED OF THESE INDIVIDUALS THAT HAVE THIS PASSION AND MISSION FOR CURING CANCER THAT IS REALLY INSPIRING AND A LOT OF FUN TO WORK WITH THIS LARGE NUMBER OF FEDERAL EMPLOYEES. SO I THOUGHT WHAT I WOULD DO IS MAYBE GIVE FOR THOSE OF YOU -- WHAT I FOUND MOST SURPRISING ABOUT THE NCI IS MOST OF THE THINGS THAT SURPRISE ME AND THE WAY IT'S DIFFERENT FROM OTHER NI H ALL REALLY KIND OF DATE TO THIS, THE CANCER ACTED OF 1971. NCI WAS CREATED BY ROOSEVELT IN 1937 BUT I THINK IT WAS MODERNIZED BY THIS ACT SIGNED BY RICHARD NIXON AND IT DID A NUMBER OF IMPORTANT THINGS FOR THE NATIONAL CANCER INSTITUTE AND LED TO SOME OF THE DIFFERENCES THAT THE NC I HAS COMPARED TO THE OTHER IC'S. SO ONE THING IT DID WAS PROIM MORE MONEY FOR THE NCI, SO IT CELLED THE FUNDING SUBSTANTIALLY AT THAT TIME. S ALSO MADE THE NCI DIRECTOR PRESIDENTIAL APPOINTEE CREATED TWO SPECIAL BOARDS ACCIDENT NATIONAL CANCER ADVISORY BOARD APPOINTED BY THE WHITE HOUSE AND PRESIDENT'S PANEL, ASKED NCI TO WRITE A PROFESSIONAL BYPASS BUDGET, NOT THE ONLY INSTITUTE AT NIH WITH THAT ARE CAPACITY BUT THE FIRST OF THE MPLEZ FROM. IT MANDATED THAT NCI CREATED AN INTERNATIONAL CANCER DATABASED WITH REIMMUNE RAITIONZ TO GO ON AND BECOME SEER, EXPAND UNDERSTAND THE RESEARCH FACILITIES, THIS ACT AND A FOLLOW-UP LAW FOR THE NATIONAL CANCER INSTITUTE AND LED TO THE CREATION OF FREDERICK NATIONAL LAB WHICH HAS INTERESTING CAPABILITIES. AND IT SORT OF MANDATED THE NC I DIRECTOR PLAY THIS ORGANIZATION AL ROLE IN THE NATION'S CANCER EFFORTS AND ONE OF THE WAYS IT SUGGESTED A WAY TO DO THAT WAS TO CREATE CANCER CENTERS SO IT ACTUALLY AT THE TIME SPECIFIED THERE WOULD BE 15 CANCER CENTERS, THERE ARE NOW 70 SO IF YOU THINK ABOUT SEER, THE CANCER CENTER, NATIONAL LAB, SOME OF THE BIGGEST AND MOST DIFFERENT CAPABILITIES OF THE NC I, THEY ALL REALLY SORT OF DATE TO THIS. I WILL BRIEFLY TALK A LITTLE BIT ABOUT THOSE. FREDERICK NATIONAL LAB IS, WE ALWAYS SHOW THIS SHINY BUILDING, BUT I THINK THIS CONFUSES PEOPLE THIS IS ACTUALLY THE ATRF, ADVANCED TECHNOLOGY RESEARCH FACILITY IN FREDERICK, AND IT IS IN FREDERICK, BUT REALLY WHAT FREDERICK IS INITIALLY WAS A DIFFERENT FACILITY IN FORT DIETHRICH AND THAT IS WORTH VISITING, THAT IS THE STEAM PIPES ARE ABOVEGROUND THAT LIKE DATE TO 1910, AND MANY OF THE BUILDINGS HAD TO BE REDONE BECAUSE OF ASBESTOS, SO WHEN PEOPLE SAY FREDERICK, I'M NEVER QUITE SURE IF THEY'RE TALKING ABOUT THE ATRF WHICH IS A GORGEOUS NEW SHI ANY BUILDING, TALKING ABOUT FORT DIETHRICH OR THERE ARE ACTUAL A FEW OTHER THINGS WE HAVE UP IN FREDERICK, SO I'VE COME TO THINK OF FREDERICK AS MORE OF A STATE OF MIND THAN A LOCATION, AND WHAT FREDERICK IS IS A GOVERNMENT OWNED CONTRACTOR OPERATED ENTITY , GOCO, SO IT MEANS THAT THE NCI PROVIDES FUNDING AND THEN HAS A CONTRACTOR AND AT THE PRESENT TIME IT'S LIDOS AFFECT THAT VISION. THAT IS A NICE FRAMEWORK FOR A NUMBER OF REASONS. PARTICULARLY, IT ALLOWS THE NCI TO GET CERTAIN THINGS DONE IN A QUICK WAY, SO THERE ARE CERTAIN KIND OF CORE-LIKE ACTIVITIES, LIKE WE NEED TO MAKE AN ANTIBODY FOR A CANCER TRIAL, WE HAVE A GENE P FACILITY, WE HAVE THE PERSONNEL THAT CAN DO THAT, THAT WOULD BE THE KIND OF THING WE CAN DO ON A RAPID -- IN A RELATIVELY RAPID WAY. AND I THINK THIS CAPABILITY HAS PROVEN VALUABLE TO THE REST OF THE NIH. FOR EXAMPLE, N I AD HAS A NUMBER OF ACTIVITIES THROUGH FREDERICK AS WELL NOW AND FREDERICK HAS WORK ON THE EBOLA VACCINE FOR EXAMPLE AND THINGS LIKE THAT, SO FREDERICK HAS AN IMPORTANT SET OF K5EU7 ABILITIES TO THE NATIONAL CANCER INSTITUTE AS WELL AS -- OF CAPABILITIES TO THE NATIONAL CANCER INSTITUTE AS WELL AS IC'S. HAROLD VARMAS DECIDED WE HAD TO HAVE FREDERICK NATIONAL LAB AND CAME TO THE CONCLUSION IF WE HAD TO HAVE IT, IT HAD TO BE GREAT. SO HE WHEN HE WAS NCI DIRECTOR STARTED A NUMBER OF THINGS TO TRY AND RAISE THE PROFILE AND THE QUALITY OF THE SCIENCE AT FREDERICK NATIONAL LAB. ONE IS HE DESIGNATED IT A NATIONAL LAB, IT IS THE ONLY NATIONAL LAB IN HHS, ALL THE OTHER NATIONAL LABS THAT YOU KNOW OF LIKE ARGONNE AND OAK RIDGE AND THINGS LIKE THAT ARE IN DOE. HE ALSO CREATED ADVISORY BOARD, FNLAC, ADVISORY BOARD THAT ADVISES ME AND HAD TRIED TO PUT GREAT SCIENCE IN IT. THE MODEL THAT WAS INITIALLY TESTED WAS THIS SORT OF VISITING SCIENTIST MODEL WHERE WE CREATE A HUB AND SPOKE MODEL THAT'S RUN BY SOMEONE I AM IMMINENT IN THE FIELD AND THIS WORKS WELL FOR THIS THING CALLED THE RASS INITIATIVE WHERE THE NCI HAS TRIED TO EFFECTIVELY DRUG RASS, THAT'S THE FIRST OF ALL DRUG TARGETS, DESPITE 40 YEARS OF FAILURE IN THAT FIELD, WE DECIDE TO DO APPLY REALLY MODERN TECHNOLOGY AND STRUCTURAL BIOLOGY TO DEVELOP THERAPEUTIC APPROACHES TO RASS, BEING LED BY FRANK McCORMICK A VISITING SCIENTIST FROM UCSF AND FORMER CANCER CENTER DIRECTOR. FREDERICK NATIONAL LAB IS IMPORTANT, WE HAVE TECHNOLOGY CHARACTERIZATION LAB, WE HAVE A VERY SUCCESSFUL CRYO-E FACILITY BEING RUN FOR OVER A YEAR, DONE OVER 100 PROJECTS T PAPERS IN PROMINENT JOURNALS, HIGHLY USED AND SUCCESSFUL, AND I THINK WE HAVE PLANS TO OPEN A CELLULARS FACILITY IN THERE, GMP FACILITY THERE WE'LL BE STARTING A PRODUCTION SITE FOR CANCER CELLS AND T CELLS. THE CSM SEER PROGRAM WAS THE FUSION OF TWO OTHER OLD CANCER REGISTRIES AND IT IS ONE OF THE MOST IMPORTANT THINGS THE NC I DOES IN TERMS OF HEALTH SERVICES RESEARCH IN POPULATION SCIENCE, SO AS I MENTIONED, THE NATIONAL CANCER ACT MANDATED THE CREATION OF SUCH A DATABASES, SEER STARTED IN 1973 ABOUT TWO YEARS LATER AND EVERY STATE IS REQUIRED TO HAVE A CANCER REGISTRY. IT'S A REPORTABLE EVENT IN THE UNITED STATES, AND IT'S HIPAA EXEMPT FOR THAT REASON. SO THAT MEANS THAT OUR STATISTICS ON CANCER IN THE UNITED STATES ARE MUCH BETTER THAN THEY ARE FOR ALMOST ANY OTHER DISEASE YOU CAN THINK OF, BUT MOST OF THE STATES HAVE A REGISTRY INDUSTRY FUNDED BY THE CDC BUT A FEW STATES NOW UP TO 33% OF THE NATION ARE COVERED THROUGH SEER CONTRACTS AND THE WAY THAT WORKS IS THAT WE HAVE TEN OF THESE CONTRACTS FOR EACH REGION AND THE PATIENT DATA ACTUALLY IDENTIFYING DATA IS GIVEN TO THOSE CONTRACTORS, IT'S AGGREGATED AND DEIDENTIFIED IN A WAY THAT IT IS SUCH CONTRIBUTED TO THE NCI AND WE SHARE IT NATIONAL AND WILL INTERNATIONALLY, AND ALSO WITH MEDICARE SOME OF THE DATA IS LINKED TO CLAIMS SO THERE'S THE SEER MEDICARE DATABASE WHICH IS PROBABLY THE MOST WIDELY USED DATASET FOR CANCER RESEARCH WITH REGARDS TO TREATMENT OUTCOME IN THE WORLD. SEER IS QUITE A THING. IT'S NOW BEEN RECOME PEELTED, THIS SLIDE IS NO -- RECOMPETED. IT'S NOW UP TO IT 38% OF THE POPULATION DPLRKS 450,000 CASES A YEAR SEER. 450,000 PALTOLOGY REPORTS. PATHOLOGY REPORT LEUKEMIA THESE DAYS, 30, 40 PAGES THESE DOCUMENTS CAN BE. WE HAVE A HUGE DATA PROBLEM WITH SEER. SEER IS MUCH MORE THAN LIKE LMS ARE CURES FOR COLON CANCER, IT HAS BIG ROBUST DATA CHALLENGES, THIS IS THE BIGGEST OF OUR BIG DATA PROJECTS, WE'VE BEEN THINKING A LOT ABOUT WHAT NEXT TO DO WITH SEER AND HOW TO MODERNIZE SEER, A VERY INTERESTING PILOT PROGRAM IN GEORGIA WHERE WE'VE LINKED THE SEER DATA TO THE CASE DATA TO THE PHARMACY OUTPATIENT PHARMACY FILLING CLAIMS FOR WALGREENS, SO WE KNOW WHO, YOU KNOW, HOW TO DIAGNOSE LYMPHOMA AND ALSO HAVE A PRESCRIPTION FILLED FOR AN ORAL ALKYLATING AGENT FOR EXAMPLE SO WE CAN DO FASCINATING CAN MULTIDATASET MATCHING PROJECTS LIKE THAT. SO I THINK SEER ALSO HAS SOME OF THE BEST DATA IN TEMPLETZ USAGE OF DRURGZ IN THE REAL WORLD. THERE ARE A BUNCH OF NEW PD12 ANTIBODIES, CHECKPOINT INHIBITORS WORKING FOR CANCER. I WOULD DEFY YOU TO FIGURE OUT HOW THEY'RE BEING USED IN THE COMMUNITY WITHOUT GOING TO SEER MEDICARE, THAT'S REALLY THE BEST SOURCE OF WHAT DRUG IS BEING USED BY WHOM FOR WHAT PURPOSE SOTS A REAL RESOURCE. THE PRESIDENT'S CANCER PANEL IS A THREE PERSON PANEL CREATED TO GIVE I THINK REALLY -- I SPOKE TO VINCE DAVIDA ABOUT THE HISTORY, HIS CONTENTION IS THIS WAS CREATED TO GIVE THE INSIDE DIRECTOR SOME ENTREE INTO THE WHITE HOUSES, TALKING TO CONGRESS AND THE EXECUTIVE BRANCH AND THE IDEA WAS THAT IT WOULD BE SHARED BY A PROM NEBILITY SORT OF CANCER FIGURE AND PASS -- CAN PROMINENT SORT OF CANCER FIGURE AND CHAIRS, AND IT WOULD TAKE ON TOPICS OF THEIR CHOOSING. A NUMBER OF PCP REPORTS HAVE BEEN DONE OVER THE YEARS, THEY TYPICALLY GET ABOUT ONE A YEAR OR EVERY OTHER YEAR DONE. THE MOST RECENT PRESIDENT'S CANCER PANEL WAS CHAIRED BY BARB REIMER, MY FORMER DEAN AT THE UNIVERSITY OF NORTH CAROLINA IN THE SCHOOL OF PUBLIC HEALTH AND THEY FOCUSED ON INTERESTING THINGS. THIS IS THE MOST RECENT REPORT ON DRUG PRICING, THIS CAME OUT AT A VERY SIMILAR TIME AS TWO OTHER REPORTS, ONE FROM THE NATIONAL ACADEMY -- I MEAN NATIONAL -- FROM NAS AND ONE FROM THE COUNCIL OF ECONOMIC ADVISORS. THE PCP ALSO DID REPORTS ON HPV VACCINATION, THAT MAYBE ONE OF THE MOST CAN IMPORTANT REPORTS THE PRESIDENT'S PANEL HAS DONE OVER THE PAST DECADE OR SO, HAS BEEN WIDELY CIRCULATED AS THE ARGUMEN FOR WHY WE NEED TO BE DOING MORE VACCINATION ENTER ACIALLY AS WELL, DID INTERESTING REPORT ON SORT OF RURAL CONNECTIVENESS TO THE INTERPRET AND CANCER OUTCOMES WHICH IS INTERESTING. PCP IS INDEPENDENT FROM THE NCI SO WE MANAGE IT ADD MIIVELY AND ORGANIZE THE MEETINGS BUT THEIR CONCLUSIONS AND THOUGHTS ARE THEIR OWN. THEN I MENTIONED THE CANCER CENTERS, WITH OKLAHOMA STEVENSON CANCER CENTER WHICH IS NOT EVEN A DOT ON MY MAP YET I'M SEEING, SHOULD BE RIGHT THERE, WE'RE NOW UP TO 70 NCI DESIGNATED CANCER CENTERS. THERE'S THREE KINDS. CLINICAL CANCER CENTERS, THERE'S THE BASIC SCIENCE CANCER CENTERS AND THEN THE COMPREHENSIVE CANCER CENTERS THAT HAVE ALL THE CAPABILITIES. THESE ARE AS I SAID WEESH FIRST SORT OF STARTED WITH THE NATIONAL CANCERS ACT AND ARE I THINK HAVE BEEN WIDELY POPULAR. THEY ARE CERTAINLY POPULAR WITH THE ADVOCACY COMMUNITY, THE PATIENT COMMUNITY AND THE LEGISLATORS. AS A FORMER CANCER CENTER DREK TORQUES I FEEL LIKE THE CANCER CENTERS DO A GREAT JOB OF DISSEMINATING BEST PRACTICES IN CANCER RESEARCH TO THE COMMUNITY AND ALSO ARE REALLY NOW SOME OF THE REAL HOD BEDS OF CANCER PLACES, PLACES LIKE SLOAN CATER ING AND M.D. ANDERSON AND THE MAJOR UNIVERSITIES. I THINK, YOU KNOW, THIS IS IMPORTANT TO REALIZE THIS IS AN EXPENSIVE PROGRAM, SO IF WE DIDN'T HAVE THE CANCER CENTER PROGRAM, WE WOULD HAVE HIGHER PAY LOTS FOR SURE ACCIDENT I CAN SAY THAT IS DEFINITELY TRUE. THE PAY LINES FOR RO 1Z ARE LOWER IN NC I THAN SOME OTHER I C'S. I WOULD ARGUE THIS PROGRAM IS WORTH IT BUT IT IS SOMETHING THAT IS RELATIVELY UNIQUE AT NIH THERE AREN'T REALLYIES AT THIS SCALE IN HISTORY ELSEWHERE. ONE CONCERN WE HAVE ABOUT THIS PROGRAM IS ONCE YOU BECOME A CANCER CENTER, IT IS VERY HARD TO LOSE CANCER CENTER DESIGNATION. IT BECOMES A THING UNTO ITSELF AND IS VERY POPULAR WITH THE SENATOR FROM THAT STATE AND PRRLZ ANDY TOLD ME THIS IS THE NUMBER ONE REASON HE WOULD GET PHONE CALLS FROM CONGRESSMEN AND I WOULD SAY THAT'S THAT'S BEEN MY EXPERIENCE THUS FAR AS WELL. THAT ASIDE, IT IS A VERY IMPORTANT PART OF OUR MISSION AND I REALLY ENJOY WORKING WITH THE CANCER CENTER DIRECTORS AND I FEEL LIKE THE ABILITY TO TALK TO THEM AND GET ADVICE FROM THEM AND MOVE THINGS IN THE COMMUNITY THROUGH THEM IS A VERY PORCHLT PART OF THE NCI'S MISSION. SO LET ME TURN NOW A LITTLE BIT, THIS IS A RECENT DATA FROM THE ANNUAL REPORT TO THE NATION, A DOCUMENT THAT'S CREATED EVERY YEAR BY THE AMERICAN CANCER SOCIETY, THE NCI AND THE CDC ON SORT OF THE STATE OF CANCER. AND I THINK THIS MAKES THE POINT THAT IT'S A PRETTY GOOD TIME TO BE DIRECTOR OF THE NATIONAL CANCER INSTITUTE. THERE'S A LOT GOING ON IN CANCERS ACCIDENT A LOT OF INTERESTING RESEARCH, A LOT OF INTERESTING NEUROMODALITIES, WE'RE MAKING REAL PROGRESS, THERE'S A REAL SENSE OF ENTHUSIASM, AND I THINK IT HAS TO BE SAID THE SUPPORT FOR CONGRESS, FROM CONGRESS FOR CANCER RESEARCH HAS BEEN GREAT. THE SUPPORT FROM CONGRESS FOR THE NIH IN GENERAL HAS BEEN GREAT AND I THINK CANCER IN PARTICULAR HAS BENEFITED FROM THAT SUPPORT. BY THE WAY, NOW THAT I HAVE BEEN ON THIS SIDE AND I'VE BEEN HERE EIGHT MONTHS AND I SORT OF KNOW HOW THINGS WORK, I THINK THAT A LARGE PART OF THAT CREDIT FOR THAT GOES TO FRANCIS IN BUILDING ONE, THEY HAVE DONE A GREAT JOB OF COMMUNICATING TO THE LEGISLATURE ABOUT HOW IMPORTANT BIOMEDICAL RESEARCH IS AND WHY IT BENEFITS EVERYBODY, SO WHEN I GO DOWN THERE TO TALK TO LEGISLATORS, IT'S JUST GENERALLY BORDERS ON A LOVE FEST, THERE'S THIS BIPARTISAN APPEAL OF THE NI H AND IT HAS GOT THIS GREAT BRAND AND I THINK THAT'S REALLY A TESTIMONY TO THE CONTINUING LEADERSHIP OF DR. COLLINS AND COLLEAGUES. SO, YOU KNOW, CONGRESS LIKES US, STUFF IS HAPPENING, AND THE STATISTICS BEAR THAT OUT. SO, YOU KNOW, IT'S A LUCKY TIME TO COME TO THE NC I. SO THIS SHOWS THE DEATH RATES FOR MEN AND WOMEN OF THE MOST COMMON CANCERS, AND YOU CAN SEE MOST THINGS ARE GOING DOWN. YOU KNOW, THIS IS REMARKABLE, BY THE WAY. 4% DECREASE IN LUNG CANCER DEATH FOR MEN, YOU KNOW, ANNUALLY. THESE TRENDS BY THE WAY HAVE BEEN GOING ON SINCE REALLY THE 1990S, SINCE LIKE 1993. SO THE PEAK INCIDENCE AGE ADJUSTED MORTALITY WAS ABOUT 250 I THINK AND WE'RE DOWN TO ABOUT 160. SO A SUBSTANTIAL IMPROVEMENT. NOW WE'RE START TO GO SEE IMPROVEMENT IN A LOT OF THE WORSE SOLID TUMORS, THE THINGS THAT HAD BEEN HARD TO MAKE PROGRESS ON FOR MANY YEARS BECAUSE OF A VARIETY OF NEW APPROACHES. BY THE WAY, THIS DATA ONLY GOES THROUGH 2015 SO THE EFFECT OF IMMUNOTHERAPY ON CANCER OUTCOMES I WOULD ARGUE IS NOT REALLY REFLECTED TO DATE, THIS IS MOSTLY OLD KINDS OF AGENTS AND NOT SMOKE AND GO PREVENTION MEASURES. SO GREAT PROGRESS. I GUESS THE BAD NEWS TO ME IS UP HERE. WE SEE A LOT OF LIVER CANCER IS BECOME AN ISSUE IN THE UNITED STATES. LIVER CANCER IN THE UNITED STATES USED TO BE LARGELY DRIVEN BY CIRROTIC DISEEZS, ALCOHOLISM AND HELP B AND HEP C AND THAT IS CHANGING, WE EXPECT IN THE NEXT DECADE OR TWO THAT OBESITY ASSOCIATED NONALCOHOLIC CL HEPATITIS WILL BE THE MAJOR CAUSE OF LIVER CANCER IN THE YATES. ALSO SEE AN INCREASE IN PANCREATIC CANCER DEATH SAYS AND IN OTHER GI CANCER DEATHS THAT WE THINK ARE PARTICULARLY ASSOCIATED WITH OBESITY. AND UTERINE CANCER IN WOMEN, FOR EXAMPLE. SO IT'S NOT ALL GREAT NEWS FOR US. WE HAVE TO -- THOSE ARE EMERGING CHALLENGES FOR US. I THINK ALSO THERE ARE A FEW CANCERS WHERE MAYBE THE INCIDENCE IS STAYING FLAT BUT THE PROGNOSIS IS NOT IMPROVED SUBSTANTIALLY, LIKE GLIOBLASTOMA AND CERTAIN CHILDHOOD BRAIN CANCERS FOR EXAMPLE WHERE I WOULD ARGUE WE NEED NEW IDEAS. I THINK WE HAVE TRIED A LOT OF CLINICAL TRIALS AND THEY HAVEN'T WORKED, SO IT'S TIME FOR I THINK A BETTER BIOLOGICAL UNDERSTANDING OF THOSE DISEASES TO MAKE PROGRESS. BUT HERE IS THE KIND OF EXCITING STUFF GOING ON, AND THIS IS REALLY ONE WEEK'S WORTH OF PRESS CLIPPINGS FROM THE NCI. THIS IS THE STUFF THAT CAME OUT RIGHT AFTER ASCO WHICH FINISHED LAST WEEK, THIS SHOWS THIS STUDY CALLED TAYLOR X THAT THE NCI STARTED IN 2004 WITH ECOG-ACRIN, STARTED AT THAT TIME WITH ECOG, NOW IT'S ECOG-ACRIN, AND IT SHOWED THAT WOMEN WITH HORMONE RECEPTOR POSITIVE BREAST CANCER SCORE USING THIS RNA BASE TEST THAT IS MADE BY GENOMIC HEALTH COULD SKIP CHEMOTHERAPY, IS IT THEIR JOWTD COME BY TAMOXIFEN OR SOMETHING, AFTER THEIR SURGERIES , ADJUVANT THERAPY FOR BREAST CANCER WOULD DO AS WELL AS PEOPLE TREATED WITH HORMONES ALONE. CHEMOTHERAPY IS A BIG DEAL, VERY EXPENSIVE, ON THE ORDER OF $70,000 A PATIENT FOR CHEMO THERAPY FORAGE VANLT BREAST CARNTION ALSO HIGHLY TOXIC, IT CAUSES BOTH EQ TOXICITIES AND LIFELONG TOXICITIES, SO BEING ABLE TONT GIVE THM THERAPY -- BEING ABLE TONT GIVE THIS THERAPY IN THAT SETTING IS VERY MEANINGFUL FOR PATIENTS AND PART OF A LARGER ONCOLOGY RESEARCH ON DEINTENSIFICATION IN TREATMENT. WE HAVE A LOT OF TRIALS LIKE THAT. IF YOU LOOK AT WHO FUNDS THOSE TRIALS, FOR THE MOST PART IT'S N CI. 18% OF CLINICAL TRIALS CAN IN THE UNITED STATES FOR CANCER ARE SUPPORTED BY NC I IN SOME WAY. LOOK AT THE DE-ESCALATION TRIALS THEY ARE MORE THAN TWO-THIRDS FUNDED BY THE NCI. IT'S A GOOD FIT FOR US, GENERALLY NOT IN THE PHARMACEUTICAL INTERESTS TO FIND LESS OF THEIR DRUG IS AS EFFECTIVE. SIMILARLY, WE HAD A COUPLE PAPERS ON THIS PATIENT FROM STEVE ROSENBERG, SO STEVE NOW HAS SORT OF ADOPTED, HE'S BEEN DOING T I LS FOR A LONG TIME, TUMOR INFILTRATING LYMPHOCYTES AND HAS NOW MADE A MAJOR IMREUFERMENT IN THE TECHNOLOGY IN THAT HE CULTURES THEITY LS EX-VIVO AS HE'S DONE FOR MANY YEARS BUT HE NOW SELECTS THERNLINGS HE SEQUENCE MS THE PATIENT'S ENTIRE TURNLINGS FINDS ALL THE PREDICTED AN ANTIGENS, MUTATIONS TAITIONZ THAT WILL CAUSE A NEW EPITOPE, PUMSLESS THE CELLS ARE, LTD NEW EPITOPES, 20 OR 30, INFUSES, MUCH HIGHER RESPONSE RATE. IT SOUNDS LIKE SCIENCE FICTION, AND WHAT'S COMING NEXT I CAN TELL YOU IS THAT YOU'RE GOING TO GENETICALLY ENGINEER THOSE T CELL RECEPTORS USING LINTHI FLMS VIRUSES, EVERY PATIENT'S THERAPY IS DIFFERENT FROM EVERYBODY ELSE 'S, VERY FEW SHARED ANTIGENS , BUT IT WORKS. THIS PATIENT JUDY FISH WAS CURED OF METASTATIC OR APPEARS TO BE CURED, SHE'S THREE YEARS POST INFUSION, THAT'S PRETTY GOOD, STEVE HAS PUBLISHED PATIENTS WITH CERVICAL CANCER, COLANGIO CARCINOMA, COLON CANCER PATIENT, IT'S BEYOND THE ANECDOTE STAGE, IT'S NOW HUNDRED S OF PATIENTS HAVE BEEN TREATED, SORT OF ESTIMATED RESPONSE RATE IS ABOUT 15%, SO IT'S BECOMING SORT OF A LARGE SINGLE INSTITUTION EXPERIENCE I THINK A REAL CHALLENGE FOR THE N CI, I'VE STARTED REFERRING TO THIS AS THE TAXOL PROBLEM, THOSE OF YOU WHO REMEMBER TAXOL IN THE EARLY DAYS, IT BECAME EARLY IN THE TESTING OF THE DRUG THAT IT WAS PHENOMENALLY ACTIVE, WOMEN DYING OF OVARIAN CANCER WOULD LITERALLY LEAVE HOSPICE AND GO HOME AND LIVE YEARS LONGER THANKS TO PAKILTAXOL AND AS RUMOR AND WORD OF EFFICACY OF THIS SPREAD, THE DEMAND AS YOU CAN IMAGINE, EVERYBODY WHO HAD OVARIAN CANCER IN THE UNITED STATES AT SOME POINT WANTED THAT DRG AND LATER ON IN BREAST CANCER AS WELL. AND SAM BRODER, THE NCI DIRECTOR AT THAT TIME, REAL IERMTZED THAT THE WORLD'S SUPPLY OF TAXOL WAS AT THE NCI AND IT WAS LIKE ENOUGH TO TREAT 100 PATIENTS AND THE ONLY WAY TO GET MORE OF IT WAS TO CUT DOWN THIS GORGEOUS TREE IN THE PACIFIC NORTHWEST THAT WAS PROTECTED BY THE ENVIRONMENTALISTS, SO IT WAS A REAL KIND OF DR. SEUSS NOVEL OF HOW TO FIX THIS, AND IT WAS VERY INNOVATIVE BIDDING OUT PROCESS. SO WORKING WITH BMS, THEY MANAG ED TO CREATE AN INDUSTRY SYNTHESIS SCHEME THAT RATHER THAN USING THE PACIFIC EWE TREE USED THIS SCRUB BRUSH IN ENGLAND THAT NOBODY CARED ABOUT AND USING SOME WEED, YOU KNOW, BUT IT WAS LIKE THE EWE BUSH, BY THE WAY, WHO KNEW. SO THEY MANAGED TO SCALE THAT UP RAPIDLY. BUT I'M WORRIED WE'RE GOING TO START HAVING THIS, THE EVIDENCE FOR THAT BY THE WAY IS THAT STEVE HAS ABOUT 100 PATIENTS FOR EVERY SLOT ON HIS TRIALS PRESENTLY, SO I MENTIONED THE NC I IS BUILDING A CELLULAR PROCESSING FACILITY AT FREDERICK AND THAT'S PART OF THE REASON IS THAT WE HAVE BOTH INTRAMURAL AND EXTRAMURAL DEMAND FOR THIS TECHNOLOGY THAT I THINK IS GOING TO INCREASE RAPIDLY AND THE OTHER THING WE HAVE TO FIGURE OUT IS HOW TO DO IT MORE QUICKLY , MORE CHEAPLY, BETTER MANUFACTURE IN A WAY THAT'S MORE USABLE IN THE REAL WORLD. AS I ALLUDED TO, CANCER I AM THERAPY IS A BIG -- IM NOTICE STHAIRP A BIG PART DPLFT FORT R PORLT FOLIO, THIS IS A PET IMAGING OF A PATIENT WITH MYELOMA WHO IS TREATED WITH CAR T CELLS FIRST TESTED AT THE NCI AGAINST BCMA THMS T CELLS, AND ALL THE DOTS HERE ARE PR MEDULLARY DISEASE TUMOR IN THE BONE MARROW, THEY PRET TICH ALL GO AWAY EXCEPT FOR NORMAL BLADDER AND BRAIN, SUPPOSED TO BE THERE, VERY GOOD RESPONSE, WE'VE BEEN CURING PATIENTS WITH CAR T CELLS AND B CELL MALIGNANCIES FOR SEVERAL YEARS AND NOW HAVING THESE KIND OF RESPONSES IN OTHER HEMATOLODGE LICK CANCERS, THERE'S POSITIVE DATA. STILL NOT WORKING IN SOLID TUMORS BUT WE ARE WORKING TO TRY TO FIGURE THAT OUT. I THINK IT'S IMPORTANT TO MENTION THAT THE NCI'S ROLE IN IMMUNOTHERAPY REALLY DATES TO THE '70S, THE INITIAL HAD MICHAEL POTTER WON FOR ANTIBODIES BEING DEVELOPED HERE AND IT'S CONTINUED FROM THERE. IRA PASTON, FIRST PEOPLE TO THINK ABOUT IMMUNOCONJUGATES, USING ANTI- ANTIBODIES TO TARGET TOXIC AGENTS TO AGENTS. STEVE LED TO THE APPROVAL OF IL2 , FIRST IMMUNOTHERAPY APPROVAL, THEN VIRTUALLY EVERY IMMUNOTHERAPY DRUG THAT'S BEEN TESTED AND APPROVED HAS HAD SOME TESTING IN THE NC I INTRAMURAL PROGRAM AND ALSO BEEN EXTRAMURAL LY SUPPORTED. THIS IS ONE OF THOSE PATIENTS I MENTIONED THAT HAD THIS TIL THERAPY, THE SPOKE T I L THERAPY N THIS CASE IT WAS TO A SHARED ANTIGENS, HOPEFULLY MORE PEOPLE WILL RESPOND TO THIS ANTIGEN, NAS ABOUT 15% OF HUMAN CANCER, SO IT IS A MORE COMMON NEW NEO ANTIGEN. BRIEF WORD ABOUT THE CANCER MOONSHOT. I'M SURE MANY OF YOU HEARD ABOUT THIS. IT WAS QUITE HIGH PROFILE, IT STARTED WITH THE DESIRE OF VICE PRESIDENT BIDEN TO DO MORE IN CANCER RESEARCH AND THE MOONSHOT FOR THOSE OF YOU WHO DIDN'T FOLLOW ALOONG -- ALONG WAS FOIKS ED SPECIFICALLY AROUND TRANSLATIONAL IMPLEMENTATION OF GREAT IDEAS. MOONSHOT DIDN'T WANT TO FUND PURE BASIC SCIENCE OR TRAINING, IT WANTED TO TAKE THINGS THAT WERE LIKE ALMOST READY FOR CLINICAL USE AND RAPIDLY MOVE THEM INTO THE CLINIC. AND AS I SAID, IT WAS PART OF THE 21ST CENTURY CURES ACT THAT HAS PROVIDED 300 MILLION DLARPZ IN THE FIRST TWO YEARS, IT WOULD BE $400 MILLION NEXT YEAR FOR CANCER MOONSHOT EXPENDITURES, AND THE WAY WE HAVE DISPERSED THE FUNDS HAS BEEN GUIDED BY THIS PROCESS THAT THE NIH AND NC I REALLY LED OF THIS BLUE RIBBON PANEL WHERE 48 EXPERTS IN CANCER MET TOGETHER AND IDENTIFIED TEN THEMES THAT THEY FELT MET THAT GOAL OF RAPID TRANSLATION, THE TEN BLUE RIBBON PANEL RECOMMENDATION PS AND THE THEMES ARE ON THE WEB IF YOU SORT OF GOOGLE CANCER MOONSHOT, BUT MORE IMPORTANTLY, RIGHT NOW FOR EXAMPLE I THINK THERE ARE PROBABLY ABOUT 50 FUNDING ANNOUNCEMENTS THAT ARE OPEN FOR MOONSHOT RELATED ACTIVITIES AND SO I ROUTINELY SEND INVESTIGATOR S TO THAT SITE TO LOOK FOR THINGS THAT ARE, YOU KNOW, IF THEY'RE LOOKING FOR NEW FUPGD OPPORTUNITIES, THAT'S WHERE MOST OF THE NCI PORTFOLIO IS FOR THE MOMENT. AS I SAID, WE HOPE NEXT YEAR WE WOULD -- THE BUDGET FOR THE MOON SHOLT WOULD INCREASE TO 400 MILLION AND THEN IT GOES TO -- 400 MILLION ONE YEAR AND 200 MILLION FOUR YEARS AND OFF, TOTAL OF 2.8 FROM TOTALS H DLING THE MOONSHOT HAS DONE A LOT OF INNOVATIVE INTERESTING THIRNTIONZ I DON'T HAVE TIME TO GO THROUGH ALL OF THEM. LOTS OF FUNDING OPPORTUNITIES THAT OPEN ON THE WEBSITE, SOME INTRAMURAL INITIATIVES THAT ARE INTERESTING AND WORTH TALKING ABOUT, THERE IS AN INTEREST THROUGHOUT ALL THE TEN AREAS FOR DISPARITIES UNDERSERVED POPULATIONS, CANCER RESEARCH IN UNDERSERVED POPULATIONS AND I'M -- YOU KNOW, I THINK THIS INTEREST HAS BEEN MORE SUCCESSFUL IN SOME OF THOSE TEN AREAS THAN OTHERS AND WE'RE TRYING TO MAKE SURE THAT PORTFOLIO IS WHAT WE EXPECTED. BUT THIS IS THE KIND OF THING THE MOONSHOT CAN DO. AND I HAVE TO SAY THIS WAS REALLY DONE BY DOUG LOWIE AND FRANCIS BEFORE I STARTED, ONE OF THE GREAT THINGS ABOUT NCI I GET TO TAKE CREDIT FOR BUT DIDN'T DO MUCH. THAT'S THE FEDERAL GOVERNMENT BY THE WAY, I'M NOT THE ONLY ONE. THIS IS A REALLY INTERESTING PUBLIC/PRIVATE PARTNERSHIP CALLED PACT AND THE IDEA IS THAT THE MOONSHOT SETS UP THESE CENTERS OF WHICH THERE'S SORT OF FIVE, THERE ARE FOUR OF THESE THINGS CALLED SIMAX, CENTERS FOR MONITORING AND ONE DATA CENTER AT THESE PLACES AND THE CENTERS THEMSELVES ARE SORT OF, YOU KNOW , $12 MILLION EACH, THAT'S LIKE 60 MILLION FOR THE CENTERS AND THEN THE CENTERS WILL DO ANALYSIS OF CLINICAL TRIALS SUPPORTED BY OUR NATIONAL CLINICAL TRIALS NETWORKS AND OTHER NETWORKS AND ON THE ORDER OF $100 MILLION OF CLINICAL TRIALS RESEARCH SUPPORT AND THEN NOW THE PHARMACEUTICAL INDUSTRY IS COMING IN WITH $5 MILLION PER COMPANY TIMES 12 COMPANIES IS ANOTHER $60 MILLION AND THE IDEA IS THAT THIS WILL BE FOCUSED ON IN A PRECOMPETITIVE SPACE TO ANALYZE BIOMARKERS THAT WILL PREDICT RESPONSE TO IMMUNO ONCOLOGY AGENTS AND IT'S BOTH CELLULAR AGENTS LIKE CAR T CELLS AND CHECKPOINT INHIBITOR DRUGS, THINGS THAT AUGMENT CAN T CELL RESPONSE. AND PACKET IS GOING SWIMMINGLY, WE'VE HAD A NUMBER OF MEETINGS AT VARIOUS LEVELS, WE HAVE A GOVERNANCE STRUCTURE, WE HAVE CREATED A LIST OF TRIALS THAT WE WANT TO FOCUS FOR INITIAL IMPLEMENTATION OF THE SORT OF PACKET PROGRAM, WE'VE CREATED A LIST OF BIOMARKERS WE INTEND TO GET ON EVERY SAMPLE AND THERE'S A TIER 1, 2 AND 3 LIST AND IT INCLUDES ALL THE THINGS, YOU KNOW, TIER 1 FOR EXAMPLE IS EVERYTHING YOU WOULD THINK OF YOU WOULD NEED TO DO IMMUNO ONCOLOGY IN THE COMMUNITY SETTING, SEQUENCING OF THE TUMOR AND IMMUNOHISTO CHEMICAL ANALYSIS AND THINGS LIKE THAT, SO IT'S QUITE SOPHISTICATED AND ALSO HAS A WAY OF INTAKING NOVEL BIOMARKERS TO INVESTIGATE IN DETERMINING RESPONSE TO IMMUNO ONCOLOGY BECAUSE THE PROBLEM BY THE WAY TO WHICH PACKET IS SEEKING TO ADDRESS IS THAT WE KNOW IMMUNOONCOLOGY APPROACHES CAN WORK PHENOMENALLY WELL IN PATIENTS BUT THEY USUALLY DON'T WORK SO EVEN IN LUNG CANCER, WITH THE EXCEPTION OF MELANOMA, WHERE MOST PATIENTS ARE NOW RESPONDING TO IMMUNO ONCOLOGY BRIDGES, IN LUNG CANCER WHERE THE RESPONSE RATE IS FAIRLY HIGH, PARTICULARLY IN PATIENTS WITH HIGH MUTATIONAL BURDEN IN THEIR TUMOR, WE STILL HAVE THE MAJORITY OF PATIENTS NOT RESPOND, SO FIGURING OUT WHY AND HOW YOU CAN MAKE THOSE NON RESPONDERS BECOME RESPONDERS IS THE KEY QUESTION FOR THE FIELD. SINCE STARTING SHES I'VE ANNOUNCED SORT OF CAN MY KEY AREAS, THINGS I WOULD LIKE TO FOCUS ON AS NCI DIRECTOR H THEY ARE HERE. NONE OF THESE ARE NEW, THEY'RE ALL THINGS WE'VE BEEN DOING FOR A WHILE. I BELIEVE TWO THINGS, BECAUSE THERE ARE SOME NEW OPPORTUNITIES IN THESE SPACES WHERE I THOUGHT IT WAS A GOOD TIME FOR FOCUS AND ALSO THESE ARE THINGS THE NCI I FELT HAS TO DO. THERE ARE OTHER THING IN THE ARE CANCER COMMUNITY BETTER FIT FOR ADVOCACY OR ACADEMIA BUT THESE ARE AREAS BECAUSE. SCALE AND HEFT AND NATIONAL CAPABILITIES OF THE NATIONAL CANCER INSTITUTE I THOUGHT THE N CI IS REALLY FORCED TO PLAY SOME DIRECT ROLE. A FEW BRIEF WORDS ABOUT ALL OF THEM. BASIC SCIENCE IS, YOU KNOW, OBVIOUSLY SOMETHING THAT THE NC I HAS BEEN COMMITTED TO SINCE ITS INCEPTION. EVERYONE AT THE NC I BELIEVES THAT A BASIC UNDERSTANDING OF THE BIOLOGY OF CANCER IS CRITICAL TO MAKING PROGRESS IN CANCER. THE REASON I FEEL LIKE IT'S WORTH STATING THIS REAFFIRMATION TO A COMMITMENT IS THAT FOR THOSE OF YOU THAT HAVEN'T NOTICED, THERE IS THIS THING GOING ON IN CANCER NOW WHERE THERE'S A SENSE WHERE WE ARE MAKING SO MUCH PROGRESS AND THAT PROGRESS IS NOT EVEN. SO, YOU KNOW, FOR EXAMPLE, PEOPLE SEE JIMMY CARTER WITH A BRAIN METASTASIS FOR MELANOMA BASICALLY CURED BUT THEIR LOVED ONE HAS CANCER VERY LITTLE PROGRESS AND DOM THE NCI AND SAY WHY HAVEN'T YOU MADE PROGRESS IN X DISEASE, ONLY Y PERCENT OF YOUR BUDGET IS SPENLTD ON IF X DISEASE AND Y IS WAY TOO LOW, THAT COMES UP OVER AND OVER AGAIN. THE THING THAT THE NC I DIRECTOR IS CONSTANTLY ASKED TO DO IS FUND DISEASE SPECIFIC RESEARCH, LET'S DO A BIG CLINICAL TRIAL IN THE DISEASE ABOUT WHICH I MUST CURE. I HAVE GET THAT, I UNDERSTAND HOW A GUT RENCHING IT CAN BE TO SEE THUN EQUAL PROGRESS, IF YOUR LOVED ONE HAS GLIOBLASTOMA THE GREAT NEWS OF ASCO LAST WEEK DOESN'T MAKE YOU FEEL MUCH BETTER. I UNDERSTAND WHY PEOPLE FEEL THAT WAY BUT TO ME THAT'S SKIPPING A STEP F WE GO TO BIG TRIALS WITHOUT A BASIC UNDERSTANDING OF THE TUMOR, WE WON'T BE SUCCESSFUL. I AM CERTAIN FOR ONE AS A BASIC SCIENTIST THAT WE DON'T REALLY HAVE CANCER FIGURED OUT, THAT WHILE WE'VE MADE A LOT OF PROGRESS, THERE ARE STILL REAL GAPS IN OUR UNDERSTANDING THAT WE HAVE TO ADDRESSES BEFORE WE'RE REALLY GOING TO MAKE PROGRESS IN ALL DISEASE PS TO THE EXTENT WE WOULD LIKE. WORKFORCE DEVELOPMENT IS AN AREA WHERE I WOULD ARGUE THIS IS PROBABLY THE MOST IMPORTANT THING THE NATIONAL CANCER INSTITUTE DOES IS TRAIN THE FUTURE CANCER RESEARCHERS AND I WOULD ALSO ARGUE THE NC I HAS BEEN PHENOMENALLY SUCCESSFUL IN THAT, GO AROUND TO ANY INSTITUTION IN THE COUNTRY AND LOOK WHO RUNS THE INSTITUTION AND EVERYBODY HAS A STINT AT NCI AT SOME POINT, THERE FOR A FELLOWSHIP FOR TWO YEARS OR STARTED IN SOMEBODY'S LAB SO I THINK THAT WE HAVE CONTRIBUTED TO THE TRAINING AND LEADERS OF CANCER RESEARCH NATIONAL AND WILL INTERNATIONALLY BUT WE NEED TO CONTINUE TO DO THAT, I THINK THIS IS ABOUT SPENDING MONEY FOR CAREER DEVELOPMENT AND TRAINING BUT IT'S ALSO ABOUT SPENDING MONEY IN THE RIGHT WAY, SO ONE QUESTION I'VE BEEN CURRENTLY ASKING DURING MY SORT OF LEARNING AND LISTENING TOUR WHEN I WENT AROUND THE COUNTRY FOR SIX MONTHS AND TALKED TO PEOPLE ABOUT WHAT THE NCI DOES WELL AND SHOULD DO BETTER, YOU KNOW, IERVE VERY FOCUSED ON THE TOPIC OF WHAT SHOULD THE NCI BE TRAINING PEOPLE TO DO, WHAT BUILT OF EXPERTISE WILL WE NEED IN THE NEXT TWO DECADES THAT WE DON'T HAVE TODAY? I'LL TELL YOU SOME OF THOSE ANSWERS HAVE BEEN, YOU KNOW, EXPERTISE IN DATA SCIENCE, YOU KNOW, BIG DATA, BUT MORE POINTED LY NOT JUST LIKE SOMEONE TO A ALIGN YOUR BAM FILES, BUT ACTUALLY SOMEONE WHO IS LIKE A COMPUTER SCIENTIST OR DOES COMPLEX STATISTICAL METHOD LOGIC RESEARCH OR PEOPLE WHO ARE INTERESTED IN MOLECULAR DYNAMIC SIMULATION AND THINGS LIKE THIS, SO VERY SPECIALIZED EXPERT ADVERTISES IN BIG DATA THAT WE DON'T HAVE. I THINK THERE'S A FEELING THIS ONCOLOGY THAT WE'RE NOT TRAINING ENOUGH PEOPLE WITH UNDERSTANDING IMMUNOLOGY, RECOMMITMENT TO BASIC IMMUNOLOGY IS IMPORTANT TO US GIVEN THAT WILL WE NOW HAVE THIS FOURTH MODALITY, SURGERY, RADIATIONS, CHEMOTHERAPY AND NOW IMMUNOONCOLOGY, THERE ARE FEELINGS ABOUT METHOD LOGIC RESEARCH TREATED CLINICAL TRIALS , WE HAVE A COMPLAINT IN THE COMMUNITY THAT WE DON'T HAVE ENOUGH PEOPLE THAT CAN PLAN CLINICAL TRIALS FOR THE MODERN AREA OF COMPLEX ADAPTIVE DESIGN, NOT JUST CLINICAL TRIALS OF ONE AGENT ANYMORE. WE ARE WORKING ON THAT. WE ARE TRYING NEW THINGS TO BE INNOVATIVE. ONE THING WE'RE DOING IS WREF A LIVE PROGRAM CALMED THE R37 PROGRAM WHERE IF YOU GET AN RO1 AND YOU'RE AN ESI, EARLY STAGE INVESTIGATOR FOR THE NCI, IN THE PAY LINE, YOU ARE GET AN R37 INSTEAD OF RO 1-RBGS SAME GRANT, EXCEPTION OPTION FOR TWO ADDITIONAL YEARS OF FUNDING WITH VERY MINIMAL EXTRA PAPERWORK. I WANTED TO GIVE A SEVEN YEAR GRANT BUT I WAS TOLD THAT WE DANT CAN'T GIVE A GRANT TO SOMEONE IF THEY DON'T APPLY FORT BUDGET SO THEY HAVE TO SUBMIT A NEW BUDGET FOR THE FOLLOWING TWO YEARS SO WE'RE TESTING THAT OUT OUT. WE'RE NOT GIVING THAT TO ESI'S NOT INSIDE THE PAY LINE, ABOUT A THIRD OF OUR ES SI'S WE FUND THROUGH SELECT PAY, MEANING EVEN OUS THE PAY LINE, THOSE INDIVIDUALS WE'LL GIVE AN RO1 TO SO WE'LL HAVE A CONTROL GROUP THERE OF AND IN SOME TIME TEN YEARS FROM NOW WE CAN SAY DID SEVEN YEARS OF FUNDING HELP OR HURT PEOPLE COMPARED TO FIVE YEARS OF IF YOU COULD FUNDING IN TERMS OF PRODUCTIVITY. ALSO PUTTING IN NEW FUNS AT ESI, WE SET ASIDE ENOUGH FUNDS THIS YEAR TO INCREASE OUR ESI POOL BY 25%S AT LEAST SO THAT MEANS GOING FROM 80-ISH ESI'S TO MORE LIKE 1120 ESI'S. WE'LL SEE HOW THE NUMBERS GO. THIS RECOMMITMENT TO BASIC SCIENCE ALSO INCLUDES A BIG INCREASE TO OUR PG POOL, OVER $100 MILLION OF FUNDING TO THE R PG TOOL WHICH IS THE LARGEST INCREASE SINCE 2003 TO THE POOL AND INCLUDES DEDICATED FUNDING FOR ESI'S. BIG DATA I'VE TALKED A LITTLE BIT ABOUT SEER, I'LL BRIEFLY MENTION ALL OF US AT THE END, BUT REALLY THIS IS A PROBLEM IN CANCER, WE HAVE INCIDENCE DATA, GENOMICS BUT WE DON'T REALLY HAVE MUCH ELSE SO WE DON'T REALLY KNOW WHO RESPONDS TO THERAPY, WHAT RECURS, SO GETTING OUR HANDS ON BIG DATA IS A BIG ISSUE. CLINICAL TRIALS PARADIGM OF 8,000 PATIENTS, 4,000 GET DRUG X , 4,000 GET DRUG Y, YOU GET 2% DIFFERENCE IN SURVIVAL. WHAT USED TO BE A PLENARY SESSION AT ASCO DOESN'T WORK ANYMORE, NOW OUR TRIALS ARE SMALLER AND HAVE MOLECULARLY TARGETED POPULATIONS. ONE TRIAL DESIGN I'M VERY ENTHUSIASTIC ABOUT IS THIS THING CALLED A MATCHED TRIAL WHICH WE HAVE JUST STARTED RELEASING SOME OF THE DATA. THIS ENROLLED 6,000 PATIENTS AT 1100 PATIENTS IN MOLECULARLY DEFINED WAY, PATIENTS TUMOR SEQUENCED, BASIC ALLOCATIONS TO THERAPY. THIS TRIAL CLOSED TWO YEARS AHEAD OF SCHEDULE, SO IT WAS THE FAST FASTEST OCCURRING TRIAL IN THE HISTORY OF THE NCI. I THINK THIS TELLS YOU AND MOST OF THE ACRUEL WAS IN THE COMMUNITY, THERE ARE NOT 1100 CANCER CENTERS IN THE UNITED STATES. THIS TELLS YOU THAT IF YOU WRITE THE RIGHT KIND OF TRIAL AND PROVIDE ACCESS TO AGENTS THAT ARE INTERESTING AND IMPORTANT, THEN THE PATIENTS WILL COME AND WE'LL ADDRESS OUR ACCRUAL PROBLEMS THAT THE NCI HAS, IT'S A BIG ISSUE FOR US. I'LL SHOW A BUILT OF DATD FROM THE NCI TRIAL FOR THOSE YOU THAT ARE INTERESTED. THIS IS SORT OF THIS NOTION OF PRECISION ONCOLOGY. ONE OF THE COMPLAINTS AND THAT IF YOU SEQUENCE ALL THESE PEOPLE , LUR GET THE SAME RESULT IF TWO DIFFERENT CR CAN LABS DO THAT, THE ANSWER IS YES, THE RESULTS ARE QUITE ROBUST. BUT ALSO HOW MANY OF THEM WILL ACTUAL HAVE THEIR THERAPY CHANGED BASED ON SEQUENCING. AND IN THE WILD WITH 30 ARMS OPEN IT'S ABOUT 12%. SO IN THE REAL WORLD A SIGNIFICANT FRACTION OF PATIENTS WILL GET A NEW THERAPY BASED ON GENETIC TESTING WITH THE TUMOR AND SOME OF THOSE PATIENTS WILL RESPOND. WE'RE NOW STARTING TO PRESENT THE EFFICACY DATA AT MEETINGS. THIS IS I THINK HOW CLINICAL TRIALS WILL HAPPEN IN THE FUTURE THE IDEA THAT WE'LL TAKE ALL COMERS AND HAVE NO MOLECULAR DATA FOR THE PATIENTS THOSE DAYS ARE OVER. WE STILL HAVE MATCH GOING ON, THE RARE VARIANT INITIATIVE IS STILL ENROLLING, FOR THE ARMS THAT DIDN'T ACCRUE BECAUSE THE VARIANT ASSIGNS YOU TO THIS ARM IS QUITE RARE AND YOU CAN SEE THE MATCH RATE FOR THOSE ABOUT 45 OUT OF 75 PATIENTS ARE ALLOCATED TO THERAPY BECAUSE THESE PATIENTS WERE IDENTIFIED BY SOME KIND OF COMMERCIAL TESTING LIKE FOUNDATION MEDICINE AND THEN THE RESULTS WERE SENT TO US. THERE'S A PEDIATRIC VERSION GOING ON, SO THIS IS NOW ENROLLING ALTHOUGH 200 SITES IN THE UNITED STATES, CHILDREN'S ONCOLOGY GROUP AND HAS 8 ARMS OPEN. AND WE HAVE AS I SAID A LARGE NATIONAL CLINICAL TRIAL, NC I NATIONAL CLINICAL TRIALS NETWORK THAT HAS WHAT USED TO BE KNOWN APPEARS THE INTERGROUPS OR COOPERATIVE GROUPS, IT'S BEEN STREAMLINED AND SHRUNK, WE HAVE PUT NEW FUNDING INTO THIS AS WELL, THIS HAS BEEN UNDER RESOURCED FOR THE LAST FEW YEARS AND I THINK THE NCT TN HAS SUFFERED IN TERMS OF PHARMACEUTICAL ARE TRIALS -- COMPARED TO. IN TERMS. LAST QUESTION FOR THE NC I WE'RE STILL WORKING THROUGH IS WHAT CAN WE DO WITH THIS GREAT RESOURCE THE NIH IS PROVIDING WITH THE ALL OF US DATASET. THERE ARE CERTAIN KINDS OF TRIALS THAT I THINK WOULD BE IMPOSSIBLE FOR THE NC I TO DO THAT CAN FIT WITHIN THIS FRAMEWORK, LIKE THE ROLE OF NUTRITION ON CANCER INCIDENCE OVER A DECADE, SOMETHING LIKE THAT, THAT WOULD BE HARD FOR US TO FUND THROUGH ANY OTHER MECHANISM SO WE ARE VERY INTERESTEDS IN HOW TO USE ALL OF US AND IF THERE SHOULD BE SPECIFIC POPULATIONSED THAT WE SHOULD TRY TO OVERENROLL FOR EXAMPLE AND I THINK A BIG FIT FOR OUR DATA QUESTIONS IN GENERAL THROUGHOUT THE NCI. I'LL FINISH UP BY SAYING WE WORK A LOT WITH THE OTHER IC'S. THE REAL LIST IS 14 SLIDES LONG. THIS IS A SMATTERING OF EXAMPLES THESE ARE THINGS THAING ARE EXCITING GOING ON RIGHT NOW. THIS IS A REALLY COOL STUDY WHERE IT TURNS OUT PEOPLE WHO GET TYPE 2 DIABETES AS ADULTS HAVE INCREASED PANCREATIC CANCER , 1% OVER THE NEXT FEW YEARS, WE'LL COLLECT A BUNCH OF BIOMARKERS AND SEE IF WE CAN IDENTIFY EARLY ON SEFT PANCREATIC. THE OTHERS I WON'T GO THROUGH AND READ. BUT I THINK SCANNERS A PART OF, YOU KNOW, ALMOST EVERY OTHER NIH HAS SOME INTEREST IN CANCER AND CANCER PORTFOLIO SO IT'S NATURAL FOR US TO COLLABORATE IN A TRANS -NIH WAY. WITH THAT, I MAYBE WENT A LITTLE OVER, I APOLOGIZE, BUT I WOULD LIKE TO TAKE A FEW QUESTIONS IF THERE ARE ANY AND THANK YOU FOR THE OPPORTUNITY TO COME TODAY. [APPLAUSE] >> Francis Collins, MD: THANK YOU. YEAH, WE CAN TAKE A FEW QUESTIONS. IT DOESN'T MATTER IF WE SPILL OVER A LITTLE BIT INTO YOUR LUNCH HOUR. JOSE? >> THAT WAS GREAT. THANK YOU. CONGRATULATIONS ON THE SIX MONTHS GETTING US UP TO SPEED. >> NINE MONTHS. >> NINE MONTHS. SORRY. >> THOSE THREE MONTHS MATTER. [LAUGHTER] >> YOU MENTIONED THAT ONE OF THE REASONS WHY THE PAY LINE IS DIFFICULT TO INCREASE AT NCI IS THE CANCERS CENTERS WHICH WENT FROM 15 TO 70 AND ALSO MENTIONED THAT ONCE YOU BECOME A CANCER CENTER IT'S VERY DIFFICULT TO SOUTHEAST BEING ONE. -- TO CEASE BEING ONE. IT'S MORE OF A MUSICAL CHAIRS APPROACH WHERE A SUCCESSFUL PR APPLICATION USUALLY MEANS UN SEELTING ONE OF THE OTHER MEMBERS WHO COMES BACK FIVE YEARS LATER TRYING TO COME BACK. DID YOU PLAN TO KIND OF TAME THE TIGER? WHAT IS THE TREND FOR THE CANCER CENTERS AND, YOU KNOW -- >> THERE IS IMMENSE DISCUSSION ON THIS TOPIC. I SHOULD MENTION THAT IT'S NOT JUST THE CANCER CENTERS, OUR SPORE PROGRAM, SPECIALIZED -- YOU KNOW, I THINK WHAT MOST PLACES HAVE, OTHER IC'S HAVE IN TERMS OF THESE CENTER GRANTS RESPECT MORE SIMILAR TO THE SPORE PROGRAM, SPECIALIZED RESEARCH EFFORTS, AND THOSE ARE QUITE COMPETITIVE AND PEOPLE GET DESPORED AND RESPORED AND THAT IS A DIFFERENT THING. THE CANCER CENTER PROGRAM BECAUSE OF ITS LEGACY IN HISTORY IS SOMEWHAT DIFFERENT AND I CAN SAY THAT IT'S, YOU KNOW, AT EVERY INSTITUTION THAT HAS A CANCER CENTER IT IS CLEARLY A LOST LEADER. THE SIZE OF THE GRANT RELATIVE TO THE BURDEN OF HAVING A CANCER CENTER IS SUCH THAT YOU WOULDN'T DO IT FOR THE MONEY, IT'S REALLY THE NC I DEZ NATION AND ALL OF THESE PLACES USE IT IN THEIR MARKETING MATERIALS AND WANT TO USE IT TO DRIVE PATIENTS TO THEIR CENTER VERSUS COMPETITORS SO IT'S BECOME HIGHLY VISIBLE AND VERY, VERY IMPORTANT. I THINK THE LAST CENTER TO LOSE NC I DESIGNATION WAS IN LIKE SOUTH FLORIDA ALMOST 1R5 YEARS AGO OR SOMETHING LIKE THAT -- 15 YEARS AGO OR SOMETHING LIKE THAT I HAVE ASKED IF WE CAN BE MORE -- ENFORCE THE ROLE -- THE RULES A BIT BETTER AND I THINK THAT WE PROBABLYIED CLRS SEE THE OCCASIONAL CENTER LOSE NCI DESIGNATION OVER THE NEXT FEW YEARS, I THINK THAT WILL HAPPEN ON ACTUALLY CRACKING DOWN ON WHAT IT MEANS TO BE A SERPT, IT'S NEVER GOING TO BE A COMMON THING HFLT IT'S IMMENSELY POP LARP WITH THE SIT CITIZENS OF THAT CATCHMENT AREA AND LEGISLATURE OF THAT CATCHMENT AREA AND IT'S A TOUGH TIGER TO TAME, USING YOUR WORDS. I THINK WE'VE BEEN THOUGHTFUL ABOUT HOW WE FUND THOSE CENTERS AND WHAT SORT OF INCREASES TO THE GRANT WE ALLOW, BUT IT IS AS I SAID WILDLY POPULAR AND ALSO REALLY IMPORTANT. I MEAN, IT DOES GIVE US CAPABILITIES THAT I'M GLAD WE HAVE. >> THANKS FOR THAT, AND CONGRATULATIONS ON THE TAYLOR RX RESULTS AND TRIAL. I'M JUST WONDERING HOW YOU THINK , GIVEN THE PROLIFERATION OF GENOMIC SIGNATURES AND OTHER POTENTIAL CANCER DIAGNOSTIC PROGNOSTIC TESTS, HOW DO YOU THINK ABOUT SCALING THAT, BECAUSE IT SEEMS LIKE IT'S AN UNTENABLE SITUATION GIVEN THE AMOUNT OF DATA THAT'S BEING PRODUCED AND WHAT NEEDS TO BE DONE TO ACTUAL GET IT INTO CLINICAL CARE. FOR MORE PRECISE MOLECULAR UNDERSTANDING OF CANCER PRIOR TO THE TREATMENT OF PATIENTS S YOU KNOW, A FORCE IN ONCOLOGY. I WOULD ARGUE IT'S SORT OF MAJOR THING GOING ON IN OUR FIELD RIGHT NOW. AND EVEN AS A DRIVING FORCE OF HOW WE USE IMMUNOONCOLOGY. SO IMMUNOONCOLOGY IS THE MOST VISIBLE THING HAPPENING RIGHT NOW, IT'S WHAT'S IN THE NEW YORK TIMES, BUT IF YOU REALLY LOOK AT WHAT'S REALLY HAPPENING, IT'S THAT WHEN YOU HAVE LUNG CANCER, YOU DON'T HAVE LUNG CANCER ANYMORE, YOU HAVE SEQUENCED LUNG CANCER AND YOU RAPIDLY DETERMINE IF IT'S EGFR OR ALK OR RASS OR HIGH TMB AND DEPENDING ON THOSE RESULTS YOU GET PC19 OR WHAT, SO I THINK IT'S REALLY BECOMING THE DRIVING THING, AND THE GOOD NEWS IS THAT WE HAVE A WAY OF DEALING WITH THIS, YOU KNOW, FOR MANY YEARS NOW PATHOLOGISTS AT BOAST CANCER CENTERS AND COMMUNITY HOSPITALS HAVE BEEN COMFORTABLE WITH THE NOTION OF GETTING SOME LIMITED REPERTOIRE OF MOLECULAR TESTS ON THEIR PATIENTS, WHICH REALLY STARTED WITH IMMUNO CHEMISTRY BUT HAS NOW ALSO MORPHED INTO I THINK SEQUENCING IS NOW DONE ROUTINELY IN ALMOST ANYPLACE THAT TREATS CANCER PATIENTS FOR CERTAIN DIAGNOSES, BUT THE QUESTION THEN, YOU KNOW, GOING FROM ONE OR TWO TESTS PER TUMOR TO PANEL SEQUENCING, WHICH IS ULTIMATELY MORE COST-EFFECTIVE AND I BELIEVE BETTER, THAT IS A BIG CHALLENGE FOR THE FIELD. THERE HAVE BEEN TWO RECENT DWOMENTSZ THAT ARE IMPORTANT, SO NOWR A FEW OF THESE TESTS ARE FD A APPROVED, MOST VISIBLE ONE BEING FOUNDATION MEDICINE, A 400 GENE PANEL, AND AS OF A FEW MONTHS AGO, CMS IS PAYING FOR IT IN THE MEDICARE POPULATION AND I EXPECT OTHER HEALTHCARE PROVIDERS WILL START PAYING FOR THIS SOON TOO. IT WAS INTERESTING TO WATCH THIS PROCESS. I WOULD SAY I READ THE COMMENTS ON THE CMS WEBSITES CAREFULLY, THERE WERE LIKE EIGHT PAGES OF, YOU KNOW, 8 POINT FONT COMMENTS, 50% OF THE WORLD LOVED THIS IDEA , THE PATIENT ADVOCATES, PEOPLE WITH METASTATIC CANCER, THEY LOVED THE IDEA THAT THEY COULD GET MOLECULAR AGAINST OF THEIR TUMOR -- DEFINITION OF THEIR TUMOR, I WOULD SAY 40% OF THE WORLD WERE MOLECULAR PATHOLOGISTS WHO WERE WORRIED THAT CMS WASN'T GOING TO PAY THEIR LAB, WORRY THAT YOU AT BUSINESS WOULD BE SHUNTED, AND I THINK THOSE PEOPLE WERE HAPPY WITH THE DECISION TO MAKE IT BASICALLY TO STILL ALLOW SOME SORT OF MOLECULAR TESTING AT THE INSTITUTES THAT ARE DOING IT. BUT THEN THERE WAS THIS SORT OF 10% OF THE WORLD WHO ARE NOT GOING AWAY BY THE WAY WHO ARE BECOMING IF ANYTHING MORE VOCAL, THAT MOLECULAR TESTING, WE'RE GETTING AHEAD OF OURSELVES, IT'S NOT READY FOR PRIME TIME YET, IT'S A WASTE OF MONEY, DOESN'T HELP MOST PATIENTS, I SHOWED EVEN UNDER THE MOST OPTIMISTIC OF MATCH IT'S SORT OF 12% OF PATIENTS, SOME PEOPLE HAVE ESTIMATED HIGHER, SOME ESTIMATED TO BE HIGHER, THOSE PEOPLE I THINK ARE DOUBLING DOWN, THERE'S BEEN SOME STUFF IN THE LAY PRESS ABOUT THIS RECENTLY. BUT I THINK I BELIEVE THIS IS GOOD NEWS. I THINK THAT, YOU KNOW, LUNG CANCER KILLS MORE PEOPLE IN THE UNITED STATES THAN BREAST CANCER , COLON CANCER AND PROSTATE CANCER COMBINED. IF THIS MATTERED FOR NOTHING BUT LUNG CANCER, IT WOULD BE A HUGE ADVANCE, AND REALLY THERE ARE PROBABLY ABOUT 12 THINGS YOU WANT TO KNOW MOLECULARLY ON ANY NEW LUNG CANCER PATIENT TODAY THAT WILL DRIVE THERAPY. I THINK ONCE IT GETS PAST ONE OR TWO THINGS, PANEL SEQUENCING IS MUCH MORE EFFECTIVE. SO I THINK IT'S HERE TO STAY, IT'S AVAILABLE TO ANYBODY IN THE COUNTRY WHO WANTS TO HAVE IT BY SENDING THEIR BLOCK ON ONE OF THESE COMMERCIAL LABS AND I THINK IT'S JUST GOING TO INCREASE. BUT MY WORRY THEN IS BUT THEN HOW DO WE INCORPORATE THE RNA TEST, WHICH IS TAYLOR RX, CAN HOW THE NEW IN FLOW MARKERS, SO IT IS A BIT OF A MESS, AND I THINK THE ONLY SOLUTION IS REALLY BIG LARGE AGGREGATED DATASETS THAT INCLUDE OUTCOMES. >> REALLY EXCITING STUFF. AND THANKS FOR THE FOCUS ON BIG DATA. BIG DATA, IT'S KIND OF LIKE DISRUPTION INNOVATION, EVERYBODY IS TALKING ABOUT T BUT WHAT YOU'RE GOING TO DO WITH IT IS USUALLY LESS CLEAR. SO I HAVE TWO SPECIFIC QUESTIONS ONE, SEER SEEMS LIKE A GOOD BIG DATA PIECE, AND MAYBE IF YOU COULD TELL US IF THERE'S ANYTHING THAT'S COME OUT OF WHAT YOU FOUND THAT'S SURPRISING YOU, THAT SURPRISED YOU, ONE OR TWO THINGS THAT CAME OUT OF THE DATASETS THAT WERE SURPRISING, AND I DON'T KNOW IF THE DATA FROM THAT IS ACTUALLY WHAT'S BEEN USED FOR THE RECENT REPORTS ON THE GENDER AND RACE GAPS AND FROM DIAGNOSIS TO TREATMENT BUT GIVEN WHAT YOU WERE LOOKING AT IT IT SEEMS LIKE IT MIEVMENT THE OTHER POINT WAS IT IS FANTASTIC THAT YOU'RE TRYING TO DO THIS ACROSS CANCER BUT AS YOU NOTED HEAVILY, IMMUNOTHERAPY IS THE WA VE OF THE FUTURE AND IMMUNO THERAPY IS IN EVERYTHING NOW, INFECTIOUS DISEASES, NON COMMUNICABLE DISEASES AND EVERYTHING, SO IS THERE AN EFFORT TO ACTUAL START TRYING TO LINK IMMUNOTHERAPY INSIDE BIG DATA ACROSS DISCIPLINE BECAUSE, YOU KNOW, THE PEOPLE WORKING ON HIV CURE, FOR EXAMPLE, ARE LOOKING AT THE SAME STUFF THAT YOU ALL DO. >> YEAH, SO A BUNCH OF STUFF THERE. YOU KNOW, I'M STILL TRYING TO UNDERSTAND EXACTLY WHAT THE NC I SHOULD DO IN TERMS OF BIG DATA. WE HAVE A NUMBER OFS PROJECTS UNDER WADE AND MORE THAT WE'RE STARTING -- UNDERWAY AND MORE THAT WE'RE START AND GO A LOFT INTERESTING DISCUSSIONS ON THE TOPIC, BUT I AM 100% CERTAIN WHAT NCI SHOULD NOT DO WITH REGARD TORE BIG DATD WHICH IS TO TRY TO CREATE THE UBER SKY NET KIND OF THIS IS THE DATA UNIVERSE YOU MUST USE BECAUSE THAT WON'T WORK. I THINK WE DON'T KNOW ENOUGH OF WHAT WE DON'T KNOW TO BE ABLE TO CREATE THAT STRUCTURE TODAY IN 2018, SO MY APPROACH I THINK HAS BEEN MORE TO SUPPORT A NUMBER OF PROJECTS THAT HAVE A BIG DATA FLAVOR THAT HAVE DIFFERENT COMPONENTS AND TO GET A BETTER IDEA OF WHAT WORKS AND WHAT DOESN'T WORK. I WOULD SAY THE THING ASURPRISED ME THE MOST ABOUT THIS EFFORT AND WILL NOT BE SURPRISING TO YOU GUYS, IT WASN'T EVEN, YOU KNOW, IT'S SURPRISING IN THAT IT'S SO MUCH MORE OF A PROBLEM THAN I ALREADY KNEW IT TO BE A PROBLEM, AND THAT'S THE ISSUE OF THE TRAPPED DATA ELECTRONIC HEALTH RECORDS, THAT IT'S RELATIVELY EASY FOR US TO GET AGGREGATED DATASETS OF GENOMICS, IRAN, DNA, WE CAN GET -- RNA, DN A, WE CAN GET CHEST X-RAY, CAT SCANS, PATH REPORT, IMAGES OF THE SLIDES SCANNED IN, ALL THAT WILL STUFF IS PRETTY EASY, BUT THEN IF YOU WANT TO KNOW IF THAT PATIENT RESPONDED OR PROGRESSED OR RECURRED THAT IS TRAPPED IN SOME DOCTOR'S NOTE, THAT IS REALLY HARD TO GET OUT OF IT AND I HAVE NOT SEEN, YOU KNOW, THERE ARE MAYBE 14 OR 15 COMPANIES THAT HAVE SOME MACHINE LEARNING APPROACH THAT WILL LIBERATE THE DATA AND WHEN YOU REALLY LOOK AT HOW THINGS WORK, ALMOST ALL OF THEM ARE THE MECHANICAL TURKOR, GREAT STORY, GOOGLE T YOU RKOR IF YOU DON'T KNOW THE STORY. THEY HAVE HUNDREDS OF PEOPLE WHO DO DATA ABSTRACTION FOR THEM WHO ARE GENERALLIES IS KIND OFF COLG NURSES OR WHAT NOT. SOME OF THOSE EFFORTS HAVE NOW ING ABSTRACTED DATASETS, SO WE'RE WONDERING APPROXIMATE WE SHOULD USE THOSE CAPABILITIES. WHAT YOU COULD DO WITH SEER IN DATA MANNING MINING TOOLS IS IT AN INTERESTING QUESTION. I THINK WE ARE TRYING A NUMBER OF SMALL INITIATIVES TO SEE WHAT WORKS AND WHAT DOESN'T, SOME OF WHICH INVOLVE SEER AND SOME OF WHICH DON'T. ONE OF THE ONES I AM REALLY INTERESTED IN IS A PROJECT WITH THE DEPARTMENT OF DEFENSE. DOD HEARPZ THE SECOND LARGEST HEALTHCARE SYSTEM IN THE UNITED STATES I THINK AND THEY HAVE A LOT OF PATIENTS AND THEY HAVE HEY LOT OF CANCER ACTUALLY SO THEY CREATED THIS PROJECT CALLED APOLLO WHERE THEY WERE GOING TO FULLY SEQUENCE RNA DNA PROTEINS, PROTEOMIC CHARACTERIZATION OF 8,000 PATIENTS, THEY THREW IN THERE THEY WERE GOING TO GET CLINICAL DATA ON THE PATIENTS TOO BUT THEY HAD NO IDEA HOW TO DO THIS SO THEY HAVE AT MY INTRODUCTION HAVE GONE TO CHICAGO, MET THE PEOPLE FROM TEM PUS, DECIDED THAT TOOL IS INTERESTING AND SEE IF THEY CAN TRAIN TEMPUS'S ALGORITHMS TO MINE THE COMMITTEE HR OF THE DOD SMALL NUMBER OF PATIENTS, 8,000 PATIENTS IS NOT A HUGE DATASET BUT THAT'S THE KIND OF PROJECT WHERE WE CAN SEE IF THAT'S REALLY USEFUL AT LEAST IN A SINGLE EHR MPLET WHICH THE -- AT LEAST IN A SINGLE EHR -- TRYING TO AN NOTICE ANNOTATE HAS 250 DIFFERENT CONTRACTS THAT GO WITH THOSE PATIENTS, EACH ONE OF THOSE IS PRESUMABLY MAYBE ONLY HALF OF THEM ARE UNIQUE EHR'S OR SOMETHING, SO IT'S A TERRIBLE PROBLEM. ANYTHING ELSE? >> FINAL QUESTION FROM FRANCIS, THEN WE'LL NEED TO MOVE ON. >> I HAVE A QUESTION ON THE DISTRIBUTION OF CLINICAL TRIALS THROUGHOUT THE COUNTRY, I WAS VERY STRUCK BY YOUR MAP OF THE DESIGNATED CENTERS, THERE'S A BIG GAP IN THE MIDDLE OF THE COUNTRY, RIGHT? >> YEAH, THAT HAS BEEN NOTICED. [LAUGHTER] >> I WASN'T SURE WHETHER THAT WAS A POPULATION DEMOGRAPHIC, CANCER PATIENT DEMOGRAPHIC, ACADEMIC HIGH CLASS CENTER DEMOGRAPHIC OR JUST POLITICS ARE BUT, YOU KNOW YOU KNOW, DOES IT REPRESENT A GEOGRAPHICAL UNDER REPRESENTATION OF PATIENTS PARTICULARLY IN THE SENSIBLE WE ALL KNOW THAT PEOPLE PATIENTS WHO DO CLINICAL TRIALS IN CANCER PROBABLY DO BETTER, ARE WE GOING ON SEE SOMETHING IN THE SEER DATA SOON AS CLINICAL TRIALS BECOME A MUCH MORE PREVALENT WAY OF TREATING PATIENTS? >> I AGREE. I THINK WE COULD HAVE A CANCER CENTER IN EVERY STATE IN THE NATION AND WE STILL ARE GOING TO NEED A ROLE IN THE COMMUNITY, THE MAJORITY OF PATIENTS JUST DON'T WANT TO GO TO CANCER CENTERS. THEY MAY GO THERE FOR A SECOND OPINION BUT THEY WANTED TO GET THEIR CARE CLOSER TO HOME. SO WE HAVE TO FIGURE OUT HOW TO DO TRIALS IN THE COMMUNITY, ENROLL PATIENT IN THE COMMUNITY. REGARDING WHERE THE SERNTLE ARE SPREAD THE THES, THEY'RE GRANTS, SO WE FUND WHAT WE GET IF IT MEETS OUR CRITERIA. FOR EXAMPLE I MENTION MEDZ THE STEVENSON CANCER CENTER IN OKLAHOMA, THEY HAD A STATE LOW LAW IN 2001, THEIR STATE SLURL MANDATED THAT THE UNIVERSITY OF OKLAHOMA WOULD TRY TO GET NCI DESIGNATION, THEY SUNK IN $400 MILLION OF TOBACCO MONEY AND PHILANTHROPY AND 17 YEARS LATER HOORAY, THAT TELLS YOU WHAT THE PROCESS IS LIKE, IT IS MY MET TAL FOR IS LIKE IT'S TAKING STALINGRAT IN FEBRUARY, IT CAN BE DONE AT TREMENDOUS COST, SOS -- >> ANOTHER METAPHOR WOULD BE BETTER. [LAUGHTER] >> WE HAVE LOOKED AT YOUR POPULATION QUESTION AND I CAN TELL YOU FOR EXAMPLE THERE IS NOT REALLY A CANCER CENTER IN SOUTH FLORIDA SO THAT IS SOMETHING LIKE 7 MILLION PEOPLE THAT DON'T HAVE ACCESS TO A CANCER CENTER. LAS VEGAS SIMILARLY HAS A QUITE BIG METROCENTER THAT HAS NO CANCER CENTER. THERE ARE A FEW PLACES LIKE THAT FOR THE MOST PART, THOSE BIG AREAS WITHOUT A CANCER CENTER ARE SPARSELY POPULATED. ED YOUR SMACH REALLY DRIVEN BY THE NATIONAL COMMUNITY RESEARCH PROGRAM, NCOR, THERE ARE 50 OF THOSE, EACH HAVE MANY SATELLITES , 900 NCOR SITES. WEAPON ENROLLED FOR MATCH IN HAWAII, GUAM, PUERTO RICO, MATCH IS MUCH MORE COMPREHENSIVE. >> THANK YOU VERY MUCH. THAT WAS REALLY INFORMATIVE. WE'RE DOING FINE BECAUSE WE ALLOWED OURSELVES A LITTLE MORE TIME THAN WE PROBABLY NEED FOR LUNCH, SO HOLD TIGHT, EVERYBODY, WE'RE NOT DONE YET, WE'LL ASK CARRIE WOLINETZ TO COME AND GIVE A QUICK REPORT FROM THE HELA WORKING GROUP, FOR NEW PEOPLE WHO HAVE NOT BEEN PART OF THIS BEFORE, THIS GROUP HAS BEEN NOW IN PLACE FOR FIVE YEARS AFTER WE MADE AN AGREEMENT WITH THE LAX FAMILY ON SUBMITTING ACCESSING HELA GENOME SEQUENCE DATA, LISA COOPER SERVED AS THE COAL CHAIR OF THIS BUT AFTER SHE FINISHED HER TENURE ON THE WORKING GROUP AND THE ACD SPARROW MANSON WAS ASKED TO JOIN I THINK I MENTIONED EARLIER THAT SPARROW CAN'T BE HERE TODAY BUT WILL BE IN DECEMBER SO AT THIS POINT I'M GOING TO TURN IT OVER TO CARRIE TO TELL YOU WHAT'S HAPPENED WITH THIS WORKING GROUP'S DELIBERATIONS OVER THE LAST SIX MONTHS. >> GREAT. I'M VERY COGNIZANT OF THE FACT THAT I'M STANDING BETWEEN YOU AND THE GROUP PHOTO, WHICH I KNOW IS AN EVENT THAT YOU ALL LOOK FORWARD TO THROUGHOUT THE YEAR AND THEN OF COURSE LUNCH. SO I WILL BE VERY QUICK IN RUNNING THROUGH THIS. AS FRANCIS MENTIONS, WE'RE LOOKING FORWARD TO HAVING SPERO JOIN AS CO-CHAIR OF THIS WORKING GROUP. SO AS WAS JUST ALLUDED TO, WE HAVE THIS UNIQUE ARRANGEMENT WITH THE LAX FAMILY TO REVIEW DATA ACCESS REQUESTED FOR ACCESS TO THE HELA WHOLE GENOME SEQUENCE DATA IN DB GAP AND ASK RESEARCHERS WHO ARE REQUESTING THIS DATA TO ABIDE BY THE TERMS IN THE HELA GENOME DATA USE GREEMENTD AS IDENTIFIED HERE. THE WORKING GROUPIE VAULTS THOSE REQUESTS FOR CONSISTENCY WITH THAT DATA USE AGREEMENT, SO I WANT TO MAKE IT PERFECTLY CLEAR, THIS IS NOT AN EVALUATION BASED ON SCIENTIFIC MERITS, WE HAVE OTHER PROCESSES IN PLACE FOR THAT OF COURSE, WHICH IS ALSO AWARDING THAT WHEN I GET TO THE DATA ACCESS REQUEST THAT I'M GOING TO BE ASKING YOU ALL TO TAKE A LOOK AT, YOU ARE WELCOME TO ASK ME ABOUT THE SCIENCE, BUT I MAKE NO GUARANTEES ABOUT WHETHER OR NOT I'LL BE ABLE TO ANSWER YOUR QUESTIONS. AND THEN OF COURSE WE REPORT FINDINGS TO ALL OF YOU IN THE AC D AS WELL AS ON OCCASION MAKING RECOMMENDATIONS RELATED TO THE TERMS OF THE DATA USE AGREEMENT ITSELF. SO THIS IS A BIT OF AN OUTDATED PICTURE NOW, BUT IT'S REALLY IMPORTANT BECAUSE OF COURSE IT POINTS TO REALLY SOME OF THE MEMBERS OF OUR WORKING GROUP IN PARTICULAR DAVID LACKS, JERRY LACKS Y AND VERONICA EXPERIENCE WHO SERVE AS REPRESENTATIVES OF HENRIETTA LACKS' FAMILY AND WE FEEL QUITE PRIVILEGED TO HAVE THEM WORKING WITH US AND REALLY TREMENDOUS CHAMPIONS FOR SCIENCE AND BIOMEDICAL RESEARCH AS WELL. SO I AM GOING TO GET TO THE ACTION ITEM HERE, WHICH IS ASKING FOR YOUR APPROVAL BASED ON THE DATA USE REQUESTS THAT WE'VE GOTTEN, BUT BEFORE I DO THAT, I WANTED TO GIVE A LITTLE BIT OF A PREVIEW OF SOMETHING THAT IS COMING OUT OF THE WORKING GROUP, A LITTLE BIT OF A DIFFERENT PRODUCT THAN WHAT YOU'RE USED TO SEEING, YOU MAY RECALL THAT IN 2014 WE DID HAVE A WORKSHOP RELATED TO SCIENTIFIC AND ETHICAL ISSUES RELATED TO OPEN ACCESS, HELA GENOMIC DATA OUT OF WHICH THERE CAME A NUMBER OF RECOMMENDATIONS AND OUTCOMES AND THAT INCLUDED A PROMISE BY THE AGENCY TO DISSEMINATE INFORMATION ON THE STATE OF THE SCIENCE USING HELA CELLS, SO THIS IS AS IT TURNS OUT A TREMENDOUS AMOUNT OF INFORMATION TO PROCESS, BUT I WANTED TO GIVE YOU A SNEAK PREVIEW OF WHAT WE WILL SOON BE RELEASING IN THIS SPACE AND TREMENDOUS CREDIT REALLY GOES HERE TO THE NATIONAL LIBRARY OF MEDICINE AS WELL AS STAFF IN THE OFFICE OF SCIENCE POLICY WHO HAVE WORKED TOGETHER TO REALLY COMPILE THIS INFORMATION AND WE'LL BE WORKING TOGETHER TO UPDATE IT OVER TIME. SO JUST TO GIVE YOU A TASTE OF SOME OF THE INFORMATION, WE'LL BE RELEASING, AS YOU CAN SEE, WE'LL HAVE VISUAL IMAGES AND LINKS TO PUBLICATIONS OVER THE CONTRIBUTION OF HELA CELL RESEARCH TO BIOMEDICAL SCIENCE WHICH I THINK CAN BE SUMMED UP IN THE WORD TREMENDOUS, THERE'S BEEN A TREMENDOUS CONTRIBUTION, SO WE REMAIN GRATEFUL TO HENRIETTA LACKS AND HER DESCENDANTS FOR THEIR AMAZING CONTRIBUTION VIA HELA CELLS, THIS IS A WORLDWIDE EFFORT. THE RANGE OF TOPICS THAT HELA CELLS CONTRIBUTE TO IS AGAIN QUITE A WIDE BREADTH OF DIFFERENT RESEARCH VARYING FROM VERY BASIC FUNDAMENTAL UNDERSTANDING TO MORE CLINICAL APPLICATIONS AND TOOLS DEVELOPMENT, AND YOU'LL GET A SENSE OF THAT WHEN YOU SEE THE DATA USE REQUESTS WE'RE GOING TO BE TALKING ABOUT TODAY AS WELL. AND THEN OF COURSE WE'VE BEEN ABLE TO TRACE BACK SOME OF THE MAJOR DISCOVERIES USING HELA CELLS IN A NUMBER OF DIFFERENT AREAS, AND YOU'LL NOTE THOSE LITTLE GOLD COINS THERE WHICH INDICATE NOBEL PRIZE WINNING DISCOVERIES, SO IT'S REALLY PRETTY BREATHTAKING THAT THE IMPACT THAT THIS ONE LINE OF CELLS HAS REALLY HAD ACROSS THE SPECTRUM OF BIOMEDICAL RESEARCH. SO WE'LL LET YOU KNOW WHEN ALL OF THIS GOES PUBLIC, IT SHOULD BE SOON, AND YOU CAN PERUSE IT AT YOUR LEISURE. BUT ONTO THE ACTION ITEM TODAY, JUST A QUICK REMINDER OF THE HELA WHOLE GENOME SEQUENCE DATA THAT IS CURRENTLY CAPTURED IN DB GAP THAT'S BEEN SUBMITTED OVER THE PAST FIVE YEARS OR SO, AND ALSO A REMINDER OF WHAT IT IS THE WORKING GROUP IS ACTUALLY LOOKING ALTHOUGH WHEN THESE DATA USE REQUESTS COME IN LOOKING AT THE, AGAIN, CRITERIA OF THE AGREEMENT THAT WE HAVE WITH THE LACKS FAMILY IS THE RESEARCH FOCUSED ON HEALTH MEDICAL OR BIOMEDICAL RESEARCH OBJECTIVES, IS IT FOCUSED CONTRARY ON THE ANCESTRY OR POPULATION ORIGINS OF THE HELA CELLS, AND THEN SOME QUESTIONS RELATED TO INTELLECTUAL PROPERTY AS WELL AS PLANS TO PUBLISH OR PRESENT FINDINGS. SO WHEN THE WORKING GROUP LOOKS AT THESE, THEY CAN DOM A NUMBER OF CONCLUSIONS -- DOM A NUMBER OF CONCLUSIONS, THEY CAN SAY THAT THE REQUEST IS CONSISTENT OR INCONSISTENT WITH THE DATA USE AGREEMENT, THEY MAY ASK FOR ADDITIONAL INFORMATION OR GIVE A CONDITIONAL RESPONSE PENDING THAT ADDITIONAL INFORMATION AND SOMETIMES THE INFORMATION IS CRITICAL ENOUGH THAT WE'LL SAY IT'S A PEND ING REQUEST , WE NEED GOATD THAT BEFORE WE CAN MAKE A DETERMINAION ONE WAY OR THE OTHER SO WE'VE HAD A NUMBER OF REQUESTS IN THE TIME PERIOD THAT THIS WORKING GROUP HAS EXISTED. 80 REQUESTS, OF 6 OF WHICH HAVE BEEN APPROVED -- 66 OF WHICH HAVE BEEN APPROVED BY THE NIH DIRECTOR, ONE DISAPPROVED OF BEING INCONSISTENT WITH THE AGREEMENTS AND A NUMBER OF THAT HAVE BEEN DISAPPROVED BY NIH STAFF BECAUSE OF INCOMPLETENESS OF THE SUBMISSIONS AND TODAY WE ARE BRINGING YOU SIX NEW REQUESTS BEING BROUGHT TO THE AC D. SO I WON'T SPEND A LOT OF TIME ON THE DETAILS BECAUSE YOU HAVE THE INFORMATION IN THE PACKETS, BUT ESSENTIALLY THESE SIX REQUESTS RUN THE GAMUT FROM TOOL DEVELOPMENT USING HELA CELLS TO BASIC UNDERSTANDING OF THE UNDER PINNINGS OF DISEASE TO SOME MORE DISEASE-SPECIFIC REQUESTS, AND IN THIS CASE, ALL SIX OF THESE REQUESTS HAVE BEEN FOUND BY THE WORKING GROUP TO BE CONSISTENT WITH THE DATA USE AGREEMENT BASED ON THE CRITERIA I'VE MENTIONED. SO WITH THAT, I AM PUTTING BEFORE YOU THE QUESTION OF WHETHER OR NOT YOU ACCEPT THE RECOMMENDATIONS OF THE WORKING GROUP TO APPROVE THESE REQUESTS BASED ON THE FACT THAT WE HAVE FOUND THEM TO BE CONSISTENT WITH THE DATA USE AGREEMENT. AND I THINK I'VE DONE THAT IN RECORD TIME, AND OPEN IT TO YOUR DISCUSSION OR QUESTIONS. >> Francis Collins, MD: THANK YOU, CARRIE, AND THARNTION TO THE WORKING GROUP MEMBERS -- AND THANKS TO THE WORKING GROUP MEMBERS WHO WORK ON THIS SO CAREFULLY TO PUT THESE RECOMMENDATIONS TO YOU. YOU HAVE THE ACD IN FRONT OF YOU SIX PARTICULAR APPLICATIONS THAT HAVE BEEN RECOMMENDED FOR APPROVAL. ARE THERE QUESTIONS OR DISCUSSION ABOUT THIS? HEARING NONE, COULD I HEAR A MOTION? >> SO MOVED. >> Francis Collins, MD: MOVEMENT TO ACCEPTED. IS THERE A SECOND? >> SECOND. >> Francis Collins, MD: ANY DISCUSSION? THEN ALL IN FAVOR, PLEASE RAISE YOUR HANDS AND SAY AYE SO EVERYBODY CAN FIGURE THIS OUT. ANNE CHURCHILL, ARE YOU STILL ON THE PHONE? OKAY. SO IT LOOKS AS IF WE HAVE, THANK YOU, A SNAN RECOMMENDATION TO ACCEPT -- A UNANIMOUS RECOMMENDATION TO ACCEPT THESE. AS USUAL, I WILL NOW TAKE YOUR RECOMMENDATION UNDER ADVISEMENT, CONSULT WITH MILL STAFF AND RENDER A DECISION IN THE VERY NEAR FULT. THANK YOU VERY MUCH, THAT'S BEEN VERY HELPFUL, CARRIE, THANK YOU FOR WALKING US THROUGH THAT PROCESS AND I'M SURE WE'LL BE DOING THIS AGAIN IN DECEMBER. >> THANK YOU. >> Francis Collins, MD: ALL RIGHT. WITH THAT, I THINK WE ARE AT THE POINT OF LUNCH, BUT FIRST, THE PHOTO. SO DON'T FORGET, WE'LL BE GATHERING ACD MEMBERS OVER THERE AND HANG OUT IN THE SET OF CHAIRS BRIEFLY AND THEN IT WILL BE TIME FOR LUNCH. AND WE'LL RECONVENE AT 1:00. >> Francis Collins, MD: WE STILL HAVE A LOT TO COVER THIS AFTERNOON, SO WE SHOULD NOT SLIP BACK SO EARLY IN THE AFTERNOON. THE FIRST TOPIC WE'LL HEAR ABOUT PRESENTED BY JOSE FLOREZ, WHO IS CO-CHAIR OF THE WORKING GROUP ON NEXT GENERATION RESEARCHERS AND ABOUT THE INITIATIVE ABOUT THEM IS GOING TO I'M SURE INTEREST YOU AND GENERATE A LOT OF DISCUSSION, SO WITHOUT FURTHER ADO, JOSE, THE FLOOR IS YOURS. >> THANK YOU, FRANCIS, AND THANKS EVERYONE FOR JOINING. THIS IS THE INTERIM REPORT FROM THIS WORKING GROUP THAT LARRY AND I HAVE CO-CHAIRED ON THIS WHAT WE THINK A VERY CRUCIAL INITIATIVE IN THE NEXT GENERATION RESEARCHERS INITIATIVE. WE HAVE BEEN PRESENTING, WE PRESENTED SOME THOUGHTS TO THE GROUP AT THE LAST ACD MEETING ASK THIS IS NOW THE INTERIM REPORT IN ANTICIPATION OF THE FINAL REPORT. SO JUST AS AN OUTLINE, I WANT TO MAKE SURE THAT ESPECIALLY THE NEW MEMBERS ARE UP TO SPEED ON THE REVIEW OF WHY WE EXIST AND WHAT WE ARE TRYING TO ACCOMPLISH THE FACT THAT THERE'S ALREADY AN NGI POLICY THAT IS IN PLACE THAT WE ARE TRYING TO PROVIDE ADVICE ON, THEN SPEND MOST OF THE TALK DESCRIBING THE ACTIVITIES THAT WE HAVE, THE DRAFT RECOMMENDATIONS THAT ARE EMERGE FRG THIS GROUP WITH JUST A COUPLE SLIDES ON THE NEXT STEPS. WE EXIST BECAUSE OF A CONGRESSIONAL MANDATE AND SO THE 21ST CENTURY CURES ACT DIRECTED FRANCIS AND THE NIH TO REALLY ADDRESS THIS WHAT SEEMED TO BE A PROBLEM WITH THE STABILITY OF THE WORKFORCE PARTICULARLY FOR YOUNG INVESTIGATORS AND I WILL JUST READ THE ITALICS, FRANCIS WAS REQUIRED BY LAW TO DEVELOP, MODIFY OR PRIORITIZE POLICIES AS NEEDED WITHIN THE NIH TO PROVIDE OPPORTUNITIES FOR NEW RESEARCH ERS, CAN CAN RESEARCHERS END PENT, TO INCREASE TUCTS FOR RESEARCHERS TO RECEIVE FUNDING, ENHANCE TRAINING, MENTORSHIP PROGRAMS AND ENHANCE THE WORKFORCE DIVERSITY. THAT WAS THE GENERAL GUIDELINE. SO FRANCIS AND HIS OFFICE THEN DEVELOPED THAT INTO A CHARGE FOR THE WORKING GROUP THAT REALLY PROVIDED THESE SIX BULLETS WITH WHICH WE WERE ABOUT A YEAR AGO TOLD TO START ASSISTING THE ACD IN DEVELOPMENT OF A TRANS-NIH POLICY, REVIEW INDEPENDENT ASSESSMENTS FOR METRICS FOR RESEARCH PRODUCTIVITY, PROVIDE ADVICE RECOMMENDATIONS AND APPROACHES TO ENHANCE FUNDING MECHANISMS FOR BOTH EARLY STAGE INVESTIGATORS, A CATEGORY THAT HAD ALREADY BEEN DEFINED SEVERAL YEARS AGO AND THEN THIS NEW CATD GOAR OF EARLY DID ARE CATEGORY OF EARLY ESTABLISHED INVESTIGATORS, ALIGN THESE REMGHTSZ WITH THE WORK OF OTHER ACD WORKING GROUPS, FOR EXAMPLE, THE ONE ON WORKFORCE DIVERSITY AND THE Ph.D.'S, ET CETERA, AND REVIEW ANALYSES ON HOW THIS IS GOING TO AFFECT THE NIH, THIS IS OUR CHARGE, VERY BROAD, ALSO VERY CONCENTRATED ON TRYING TO HELP THIS GROUP. OUR GROUP WAS DOING DELIBERATIONS SHES THERE WAS A POLICY ALREADY IN PLACE, THE NGI R POLICY, SO NIH HAD TO WORK ON AN INTERIM BASIS WHILE TRYING TO DEVELOP THESE RECOMMENDATIONS SO FOR FY2018 NIH CONTINUES TO MONITOR HOW MANY SI'S ARE FUNDED AND HOW WELL THE SI INITIATIVE IS WORKING AND HOW MANY INVESTIGATORS RAILROAD AT RISK OF LOSING NIH FUNDING RECEIVE SUPPORTED. THESE EARLY ESTABLISHED INVESTIGATOR DECISION WHEN THE POLICY WAS FIRST ROLLED OUT INCLUDED PEOPLE WHO ARE TEN YEARS OUT FROM THE ES SI AND WHO HAD EITHER ONE GRANLTD AND THEY'RE ABOUT TO RENEW DISPLRT GRANT R ABOUT TO GET A SECOND GRANTED, THAT DEFINITION WAS FLAGGED AS POTENTIALLY BEING PROBLEMATIC IN THAT IT DID NOT REALLY CAPTURE ALL THE PEOPLE MEANT TO BE RESCUED OR PROTECTED FROM THE FUNDING CR VES TUD SAYS THAT LED PEOPLE TO THE FUNDING. THERE WAS A LOT OF DISCUSSION WITHIN THE COMMUNITY AND WITHIN OUR GROUP THAT THE EEI WAS INSUFFICIENT AND THERE WAS ANALYSIS I'LL DESCRIBE LATER IN DETAIL THAT SHOWED THAT BY APPLYING THE VERY STRAIGHT DEFINITION WE'RE NOT REALLY PROTECTING EVERYBODY WHO NEEDED TO BE THE TARGET OF THESE EFFORTS. THIS INVOLVED INTO THIS NEW DEFINITION THAT I WILL PRESENT AGAIN IN GREATER DETAIL LATER OF THE AT RISK INVESTIGATOR FOCUSING ON THE INVESTIGATOR NOT ONLY ON THE SCIENCE BUT ALSO ON THE PERSON, YEARS OUT FROM AID PREVIOUS STAGE REALLY AT RISK OF LOSING FUNDING. THE WORKING DEFINITION AT THIS POINT AS SHOWN IN THE LAST BULLET IS THE INVESTIGATOR WHO HAS NOT RECEIVED FUNDING ON ANY MAJOR AWARD FROM NIH IN THE EXISTING YEAR OR WHOSE NIH FUNDING IS ABOUT TO END, THAT'S THE PERSON AT RISK OF LOSING ALL THE NIH FUNDING AND THAT IS THE PERSON THAT FOR THE STABILITY OF THE WORKFORCE WE NEED TO PROTECT OF COURSE ASSUMING THAT THERE IS MERIT IN THE APPLICATION. SO THE WORKING GROUP HAS BEEN CONVENED AND I WILL GIVE YOU A BRIEF OUTLINE, YOU CAN SEE MOST OF US HERE AT THIS IN PERSON TRRLSZ MEETING THAT TOOK PLACE IN APRIL ALL OF US ARE QUITE ARE HAPPY, EXCEPT LARRY HAS SORT OF A GAPING MOUTH, HOW IS THIS COMING TOGETHER? IT'S AMAZING THAT THAT FROM THE DIVERSITY THAT THE GROUP REPRESENTS, INTRAMURAL, EXTRAMURAL, INTERNAL AND EXTERNAL, INTERNAL NIH INVESTIGATORS, TRAINEES, JUNIOR FACULTY FROM VARIOUS PLACES, MANY DIFFERENT PERSPECTIVES AND HE'S AMAZED THAT WE'RE WORKING AND SO HAPPY WITH THIS TOGETHER. SO IT'S BEEN A REALLY GREAT GROUP. I ALSO WANTED TO ACKNOWLEDGE NICOLE, DRUK WAVE -- YOU CAN WAVE, SHE'S JOINED LARRY'S OFFICE VERY RECENTLY I WOULD SAY WITHIN THE LAST TWO OR THREE MONTHS AND TO ME IT'S REMARKABLE HOW QUICKLY SHE'S GOTTEN UP TO SPHIED WITH EVERYTHING WE'VE DELIBERATED ON, ARE ALL WE'VE PRODUCED AND HOW SHE HAS ASSISTED IN PUTTING THIS PRESENTATION TOGETHER AND MANY OF OUR MATERIALS. AND THEN FROM LARRY, I'VE ALSO LEARNED, LARRY SEEMS LIKE A VERY NICE GUY, BUT HE REALLY IS VERY SMART, VERY SAVVY AND KNOWS THE INSTITUTE VERY WELL AND I'M LEARNING A LOT FROM HOW WE'RE WORKING ON THIS TOGETHER. SO THANK YOU FOR THAT. WE HAD A VERY ACTIVE CALL WITH MANY CONFERENCE CALLS AND AN IN PERSON MEETING, AND SINCE THEN OF COURSE THERE'S THE GOVERNMENT SHUTDOWN AND SOME STAFF TURNOVER BUT WE'VE HAD TWO TELECONFERENCE S VERY PRODUCTIVE AND A VERY GOOD IN-PERSON MEETING IN APRIL THAT REALLY GAVE RISE TO THE PRESENTATION THAT I'M GOING TO UNFOLD. WE HAVE A VERY GROWING LIBRARY OF MATERIALS FROM THINGS THAT WE ARE DISCOVERING OURSELVES AND THAT ARE BEING SENT TO US AND THAT NICOLE IS COLLATING IN OUR SHARE FILE THAT'S BEEN REVIEWED FOR THE PREPARATION OF ALL OF OUR THOUGHTS AND GUIDING WHAT WE SEE. SOME OF THE MATERIAL MATERIALS HA WE READ ARE NOT ONLY THINGS THAT WE FIND BUT THINGS THAT MEMBERS OF THE WORK GROUP ARE GENERATING THEMSELVES BECAUSE THEY'RE INVESTED IN THIS AREA. THERE'S A LOT OF DATD GENERATED BY NIH ITSELF THAT IS BEING REVIEWED WITH A NUMBER OF PRESENTATIONS, THERE IS THE DATA THAT THE NATIONAL ACADEMIES HAVE ALSO USED TO ADDRESS THIS ISSUE THAT WE HAVE ACCESS TO, AND THERE ARE A NUMBER OF DIFFERENT PRESENTATIONS. HERE IS JUST A QUICK GATHERING OF MANY OF THE RECENT PUBLICATIONS THAT ADDRESS HAD PROBLEM THAT REALLY POINT TO THE MAGNITUDE AND THE INTEREST IN THIS ISSUE. THERE'S A NUMBER OF ORGANIZATIONS THAT REACH OUT TO US SO AFTER I JOINED THIS WORKING GROUP IT'S AMAZING WHAT YOUR E-MAIL IN BOX CAN DO, AND PEOPLE WHO FIND WHO YOU ARE AND WHY YOU MIGHT BE OF INTEREST TO THEM, SO MANY DIFFERENT PEOPLE HAVE BEEN WRITING AND ALSO REMARKABLE HOW THE COMMUNITY IS VERY THOUGHTFUL ABOUT THESE THINGS AND EVERYBODY HAS THE INTEREST, THE SAME GOAL REALLY IN MIND, MAYBE DIFFERENT IDEAS AND HOW TO PURSUE THAT GOAL, REALLY FOCUSED ON ALIGN WHAT WE THINK IS THE IMPORTANT ISSUE AT HAND VERY MUCH LIKE OUR COMMITTEE. SO SMFLT MAJOR THEMES WE'VE UN ERTDED AND HOPEFULLY A MATTER OF GENERAL CONSENSUS AND AGREEMENT IS REALLY THERE'S A URGENT NEED TO PROTECT JUNIOR INVESTIGATORS OF THE COUNTRY IN THE SAME WAY WE NEED TO PROTECT JUNIOR INVESTIGATORS WE NEED TO STABILIZE ALL THOSE PEOPLE WHO CAME INTO THE FIELD WHO HAVE BEEN PRODUCTIVE AND DONE TERRIFIC WORK AND BECAUSE OF DIFFERENT ECONOMIC AND FINANCIAL REALITIES ARE ON THE VERGE OF HAVING TO LEAVE THE WORKFORCE, SO THERE'S A NEED TO STABILIZE THOSE MID CAREER PEOPLE AS WELL. WE ARE COMPLETELY ALIGNED WITH THE IDEA THAT DIVERSITY IS IMPORTANT, WE SEE THE VALUE OF DIVERSITY IN PRODUCING GOOD SCIENCE AND ADDRESSING DIFFERENT QUESTIONS AND THERE IS A LOT OF ELM FA SISES ON THAT ON THE PREVIOUS ACD WORKING GROUP RMSZ BUT WE WANT TO MAKE SURE WE'RE ALIGNED WITH THOSE INITIATIVES AND INCORPORATE THAT INTO THINGS THAT SEEM TO BE OF COMMON PURPOSE. THIS DEFINITION OF INVESTIGATOR AT RISK. INITIALLY AS YOU REMEMBER AS I MENTIONED BRIEFLY THERE WAS THIS EARLY ESTABLISHED INVESTIGATOR DEFINITION THAT WAS A CHRONOLOGICAL DEFINITION AND MAYBE A DEFINITION THAT HAD TO DO WITH A NUMBER OF GRANTS PEOPLE HAD RECEIVED. AND WHEN THE POLICY GETS ROLLED OUT, THERE IS NO CLEAR DIRECTIVE ON WHERE THE FUNDS WOULD COME TO REALLY TRY TO PROTECT THOSE PEOPLE WHO ARE DEFINED AS EARLY ESTABLISHED INVESTIGATORS, AND WE SAW AN ANALYSIS CARRIED OUT BY JOHN LOURISH WITH THE DATA FROM THE 2014-2016 WHAT WOULD HAVE HAPPENED IF WE SIMPLY APPLY THOSE DEFINITIONS, WHAT WOULD HAVE HAPPENED TO THE WORKFORCE AND WE APPLY THOSE DEFINITIONS WITHOUT A DIRECTEDTIVE. THE EARLY ESTABLISHED INVESTIGATOR AS DEFINED A YEAR AGO, AND THE ANALYSIS, MAYBE ABOUT 200 OR MORE SO PEOPLE WOULD BE FUNDED THAT WOULD NOT HAVE BEEN FUNDED OTHERWISE AS YOU WOULD EXPECT BY DEFINITION BECAUSE THAT'S WHAT YOU'RE TRYING TO DO BUT THEN THAT'S AT THE COST OF WHAT, THAT IS AT THE COST OF OVER 200 OTHER PEOPLE WHO ARE ALSO AT RISK WHO ARE JUST MAYBE ONE YEAR OUT FROM MEETING THE DEFINITION, THEY HAD NOT FALLEN INTO THE BUCKET THAT WAS VERY NARROWLY DEFINED BUT THEY WERE REALLY EQUALLY MERITORIOUS AND ALSO EQUALLY AT RISK, SO IT REALLY WAS A WASH TO BE ABLE TO APPLY THE DEFINITION, SO THEN WE SHIFTED TO THIS IDEA THAT REALLY WHAT WE NEED TO DO IS TO IDENTIFY THE PEOPLE AT RISK, MERITORIOUS PEOPLE AT RISK SO THAT EMPHASIZES STABILIZATION OF THE WORKFORCE, DOES NOT UNDER MINE MERIT BECAUSE WE ARE TALKING ABOUT PEOPLE IN THE 25TH PERCENTILE AND DEMONSTRATED THAT THERE'S REALLY CLEARLY NOT A WHOLE LOT TO PREDICT, THE SUCCESS MUCH THAT PERSON'S SCIENCE WHEN YOU'RE IN THE TOP 25TH PERCENTILE, THAT NARROW GROUP OF VERY MERITORIOUS INVESTIGATORS AND BY DOING THAT, BY DEFINING THAT WE WANT TO PROTECT THE PEOPLE AT RISK, IT PREEMPTS THE NEED TO REALLY DIRECTING THAT WHERE THE MONEY NEEDS TO COME FROM BECAUSE IT ACHIEVES WHAT IS MEANT TO ACHIEVE WHICH IS PROTECTING THE PEOPLE AT NEED AND THEN IC DIRECTORS CAN DECIDE HOW BEST THAT IS DONE WITHOUT NECESSARILY TARGETING A PARTICULAR GROUP FOR RECEIVING LESS FUNDS. SO THAT IS REALLY THE REASON FOR INTRODUCING THIS DEFINITION. SOME OF THE OTHER MAJOR THEMES WE CULSED THAT WE REALLY NEED TO UNDERSTAND ANY UNINTENDED CONSEQUENCES, THE POLICY ROLLED OUT LAST YEAR, THERE WAS A CLEAR INDICATION WE NEEDED TO STUDY IN GREATER DEPTH TO MAKE SURE THINGS WERE NOT UNTOWARDS TO SOME PEOPLE SO THE POLICIES WE FEEL PROPOSE MUST BE WELL VETTED AND EVIDENCE-BASED, WE NEED TO CONTINUE TO MONITOR THEM OVER TIME, MAKE SURE THEY ACHIEVE WHAT THEY DO IN RELATIVELY SHORT PERIODS BUT AT THE SAME TIME WE NEED TO RECOMMEND TO RECOGNIZE THAT INSTITUTES AND CENTERS DO HAVE THEIR OWN AUTONOMY AND DECIDING BASED ON THEIR PARTICULAR PORTFOLIO WHAT MAKES THE MOST SENSE IN THEIR CONTEXT. THERE WAS ALSO A LITTLE BUILT OF A SHIFT THAT NIH -- LITTLE BIT OF A SHIFT THAT NIH WANTS TO FOCUS NOT ONLY ON THE SCIENCE OR PROJECT BEING PROPOSED NOT ONLY ON THE PARTICULAR RESEARCH PLAN BUT ON THE PERSON PROPOSING THE RESEARCH PLAN, THAT WE WILL REALLY CARE ABOUT HERE THE INVESTIGATOR AND THE FUTURE OF THE WORKFORCE DEPENDS ON PEOPLE AND THE PEOPLE REALLY COME UP WITH THE SCIENCE AND FINALLY THAT WE'LL USE PRODUCTIVITY METRICS EVEN THOUGH THERE WAS A LOT OF WORK SHOWING THAT BIBLIOGRAPHIC MET TRIKSZ USEFUL, THEY'RE NOT THE ONLY SOURCE OF PRODUCTIVITY, SO WE NEED TO CAST A WIDER NET AND BE MORE HOLISTIC ON HOW WE EVALUATED WHETHER NOT ONLY A GROUP OF PEOPLE BUT AN INDIVIDUAL CONTRIBUTES TO SCIENCE AS FAR AS HIS OR HER PRODUCTIVITY. ARE. ON TO THE RECOMMENDATIONS. FIEFER OR SO BASIC AREAS, I'LL UNFOLD EACH ONE. FIRST RECOMMENDATION IS MODIFYING, AS I ALREADY MENTIONED, THE DEFINITIONS IN THE POLICY SO WE'LL SPEAK ON THAT. DEVELOP METHODS TO IDENTIFY WHO ARE THESE AT RISK INVESTIGATORS AND THE EARLY STAGE INVESTIGATORS, WE'LL SPEND SOME TIME TALKING ABOUT DIVERSE IF I, OPTIMIZING THE WORK NORSE STABILITY, HERE WE NEED TO LOOK AT THE ENTIRE SPECTRUM OF PEOPLE IN THEIR CAREER STAGES AND HOW WE TARGET DISTRIBUTION OF INVESTIGATORS ACROSS TOES STAGES TO ENSURE FUTURE STABILITY AND THEN A SPHU WORDS ABOUT PRODUCTIVITY. MODIFYING THE ORIGINAL DEFINITION. WE WANT TO EXPAND THE DEFINITION OF ESI STATUS, IT WAS ABOUT TEN YEARS FROM THE TERMINAL DEGREE AND THE REASON IS BECAUSE OF TRENDS THAT WE HAVE OBSERVED FOR EXAMPLE FOR NCI, WHERE THE INSTITUTE SEEMS TO THINK THAT THE EARLY STAGE INVESTIGATORS MAYBE YOU NEED TO GO SOMETIMES TO TWELVE ORAL FIFTEEN YEARS, SO WE NEED TO GO A LITTLE BIT LONGER AND PEOPLE MAY HAVE HAD TO TAKE TIME OFF FOR WHATEVER, EITHER PROFESSIONAL OR PERSONAL REASONS FROM THEIR LAST TERMINAL DEGREE BEFORE THEY CAME BACK INTO SCIENCE AND WE WANT TO BE ABLE TO CAPTURE THOSE SIGN SCIENTISTS, SO THERE IS ONE PROPOSAL TO LENGTH EN THE ESI CHRONOLOGICAL DEFINITION FROM TEN TO FIFTEEN YEARS NOT TO MAKE PEOPLE SPEND MORE TIME IN A POSTDOCTORAL SETTING BUT TO CAPTURE PEOPLE WHO MAY HAVE HAD TO TAKE TIME OFF BUT WANT TO COME BACK INTO SCIENCE. THEN AT THE SAME TIME TO INTRODUCE A SECOND CRITERION BY WHICH A PERSON COULD CLAIM ESI STATUS, SONLT NECESSARILY THEY'RE NOT EXCLUSIVE, THEY'RE EITHER/OR, THEY'RE ONE OR THE OTHER, WHATEVER BENEFITS THE PERSON THE MOST, THAT IS WITH A STATUS CLOCK FOR ESI BEGINS AT THE TIME OF THEIR FIRST INDEPENDENT POSITION, FACULTY POSITION. WEAPON DON'T THINK THAT THIS CAN BE A SINGLE DEFINITION BECAUSE THAT VARIES FROM INSTITUTION TO INSTITUTION AND IT COULD BECOME DIFFICULT TO IMPLEMENT NATIONWIDE BUT AT LEAST IT ALLOWS A PERSON TO SAY THIS IS MY FIRST FACULTY POSITION AND MY CLOCK BEGINS TICKING FOR THE NEXT SEVEN YEARS BASED ON THIS OPERATION. SO ANY OF THESE TWO CRITERIA WOULD THEN ALLOW SOMEONE AS EARLY STAGE INVESTIGATOR AND MEANT TO WIDE N THE POOL OF PEOPLE WHO MIGHT BE PROTECTED TO BRNG IN VERY TALENTED PEOPLE INTO THE WORKFORCE. WHAT ABOUT THE EARLY ESTABLISHED INVESTIGATOR? AGAIN WE WANT TO MOVE AWAY FROM A CHRONOLOGICAL DEFINITION THAT IS PREDICATED UPON YOU HAVEN'T BEEN AN ESI IN THE PREVIOUS FEW YEARS AND DEPENDING ON YOUR GRANTS BUT REALLY IDENTIFY PEOPLE AT RISK AS DEFINED AS THOSE WHO ARE ABOUT TO LOSE ALL NIH FUNDING WITHIN THE FISCAL YEAR. THE IDEA HERE ALSO WOULD BE THAT WE WANT TO PROTECT PEOPLE SO SOMETIMES A YOUNG INVESTIGATOR IS PLACED IN THE POSITION OF HAVING TO LOSE THE LITTLE PERK OR ESI IF THEY COME IN AS A CO-P I IN AN APPLICATION THAT IS -- DISL BY WHICH JUNIOR PEOPLE WHO COME IN AS A CO-PI WITH SOMEONE ELSE DO NOT LOSE THAT EI STATUS AND THEY CAN STILL USE IT IN A GRANT OF THEIR OWN IN A SUBSEQUENT APPLICATION. THERE'S ALSO A BIG EMPHASIS TO CONTINUE TO STRALT PHI PEER REVIEW, COMPARE APPLES WITH APPLES AND ORANGES WITH ORANGES AND DON'T NECESSARILY WANT TO PUT JUNIOR PEOPLE AT A CONTINUOUS DISADVANTAGE WHEN BEING JUDGED WITH PEOPLE IT WHO HAVE BEEN DOING THIS FOR 30 YEARS. SO WE FEEL THAT ALTHOUGH RISK GRANTS PUT IN BY ALTHOUGH RISK INVESTIGATORS ALSO SHOULD BE CONSIDERED AS A BLOCK AND ALSO AT THE BEGINNING PEOPLE WHO HAVE RESTED AND HAVE THEIR COFFEE AS OPPOSED TO AT THE LAST AFTERNOON WHEN EVERYBODY IS TRYING TO GET HOME. THER ARE MANY CONSIDER INSTITUTES ALREADY INTRODUCED THAT RERS NAITD WITH A LOT OF OUR THINKING. WE'VE BEEN REVIEWING THOSE, NOT TO GO INTO DETAIL HERE, BUTS THIS MORNING HEARD FROM NED SHARPLESS ABOUT THE ESI MERIT AWARD AT NCI WHERE YOU GET FIVE YEARS PLUS TWO, A PRESENTATION WAS GIVEN ON THE AWARDS, THAT INSTITUTION THEY BET ON PEOPLE RATHER THAN THE ACTUAL SPECIFIC SCIENCE THAT IS BEING PROPOSED, THERE IS THE DIRECTORS AWARDS, EARLY INDEPENDENCE AND NEW IN INNOVATORS, ALL THESE ARE ALTHOUGH A PILOT STAGE BUT THEY PROVIDE A BLUEPRINT WE CAN LEVERAGE MAYBE TOAKS UP AND DOWN THEM THRIERNLGER EXTENT TO BENEFIT -- MAYBE EXPAND THEM TO A LARGER EXTENT TO BENEFIT MORE PEOPLE. ENHANCING DIVERSITY. THIS EFFORT TO BRING IN AND RETAIN YOUNG PEOPLE AND KEEP THEM INVESTED, REALLY NEED TO BE COGNIZANT OF THE RICHNESS THAT COMES IN WHEN THEY ALL COME FROM DIVERSE BACKGROUNDS. THERE'S A NUMBER OF RECOMMENDATIONS THAT WE THINK WOULD HELP THAT AND MANY OF THEM HAVE ALREADY BEEN PIONEERED, BY HANNA VALENTINE'S GROUP AND THE WORKING GROUP BY ROY WILSON AND OTHERS INCLUDING MYSELF PARTICIPATED N BUT ONE HAS TO DO WITH REALLY HELPING PROGRAM OFFICERS TO BE VERY INCLUSIVE AND REACHING OUT TO YOUNG PEOPLE AND HELPING THEM IN THE NEXT STAGE OF THEIR CAREERS AND BROAD SUPPORT OF THIS GROUP, UNCONSCIOUS BIAS, AN EMERGING CONCERN ABOUT -- ACROSS THE NIH AND OTHER INSTITUTIONS THAT REALLY NEEDS TO BE EXPANDED, THERE NEEDS TO BE TRAINING AT THE TIME OF PEER REVIEW FOR PEER REVIEWERS TO BE AWARE OF THESE TENDANCIES THAT WE ALL HAVE, ALL PROGRAM OFFICERS SHOULD RECEIVE TRAINING ON UNCONSCIOUS BIAS, COULD BE MAYBE PART OF THE RCR, PART OF TRAINING THAT TAKES PLACE FOR TRAINEES, BOTH AT THE EARLY STAGE, MID CAREER STAGE, AND ALSO A POINT THAT WAS BROUGHT UP BY AMY'S, ONE OF THE MEMBERS OF THE GROUP HERE, THAT THESE THINGS NEED TO BE DONE ON A REGULAR BASIS, CAN'T JUST HAPPEN ONCE, THAT IS SOMETHING THAT FALLS BACK INTO OUR SUBCONSCIOUS AND WE NEED TO BE REAUTO MINDED TO A CON -- REMIND ODD A CON STAT BASIS. GREAT AGREEMENT AND SUPPORT FOR THE CONCEPTS COMING OUT OF HANNA 'S OFFICE ON THIS TOPIC. CONTINUING THAT DIVERSITY AND INCLUSIVITY, THERE'S ISSUES THAT IS OF COURSE NOT ONLY ABOUT THE EARLY WORKFORCE BUT AT A FACULTY LEVEL AND WHAT CAN THE NIH DO TO MAYBE CHANGE CULTURE AT THE ACADEMIC INSTITUTION LEVEL BECAUSE THERE IS ONLY SO MUCH LEVERAGE THAT A FUNDING AGENCY CAN HAVE IN AFFECTING CULTURE CHANGE. SO ONE SPACE WHERE WE THINK THAT NIH HAS A LOT OF REACH IS IN TRAINING AND FELLOWSHIP AND CAREER AWARDS, SO THERE WE CAN CONTINUE TO REALLY ADVANCE THE CAUSE OF DIVERSITY, AND THERE IS MORE EXPLICIT LANGUAGE THAT CAN BE USED FOR EXAMPLE IN THIS FUNDING OPPORTUNITY ANNOUNCEMENT FROM NIGMS ABOUT INCLUSIVE ANDS -- CONSIDERS INCLUSION THAT ARE SUPPOSED TO COMMENT ON WHEN THEY SUBMIT TRAINING AND FELLOWSHIP APPLICATIONS OR CAREER AWARDS, SO AT LEAST ON THE PART OF WHAT NIH HAS PURVIEW OVER FOR TRAINING GRANTS, WE WANT TO CONTINUE HOLDING INSTITUTIONS ACCOUNTABLE FOR WHAT WE THINK LZ SHOULD BE A PRIORITY. AS FAR AS OPTIMIZING THE WORKFORCE STABILITY, ONE BIG QUESTION IS HOW MUCH CAN THE SYSTEM CARRY AND WHAT IS REALLY OPTIMUM? WE HAVEN'T SOLVED THAT QUESTION, WE DON'T HAVE A SOLUTION, BUT THERE'S A REQUEST IN THE NEXT FEW MONTHS TO TRY TO MODEL THE CARRYING CAPACITY OF THE NIH SYSTEM AND THEN WITHIN THAT WE CAN THEN DECIDE WHETHER APPROPRIATE DISTRIBUTION, WHAT THAT WOULD BE. THERE'S A GENERAL SENSE WE DON'T WANT TO MAKE DRASTIC CHANGES THAT'S RIGHT REDUCE OR INCREASE THE NUMBER OF INVESTIGATORS, YOU CAN HAVE A SITUATION WHERE YOU BRING A LOT OF PEOPLE IN BUT THEN YOU LEAVE THEM TO A CLIFF BECAUSE THERE'S NO WAY TO SUSTAIN THEM AND WHAT HAPPENS IN AN UNINTENDED FASHION MAYBE OF A DOUBLING OF THE NIH BUDGET BUT AT THE SAME TIME WE DON'T WANT TO RESTRICT, SO WE NEED TO COME UP WITH NUMBERS THAT MAKE SENSE AND THEN ALLOW FOR THE ABILITY TO CORRECT COURSE IF WE THINK THAT THE INTERVENTIONS THAT HAVE BEEN MADE ARE NOT YIELDING THE APPROPRIATE RESULTS. THE GOAL AS WE'VE BEEN CHARGED IS TO YIELD AN ELASTIC WORKFORCE THAT'S SUSTAINABLE AND HOPEFULLY GROWING BUT ALSO BE ENRICHED BY DIVERSITY AND TALENT. WE NEED TO THINK ON MAYBE WHAT ARE THE METRICS THAT WE'RE GOING TO BE USING TO ASSESS WHETHER THE INTERVENTIONS ARE ACHIEVING THE DESIRED EFFECT AND SO FOR THAT THERE IS THIS REALLY INTERESTING METRIC. ON THIS GRAPH, THIS IS NOW DONE FOR ESI, ALL NIH CAN S I APPLICATIONS IN 2017, WE'RE ABROADING THE AWARD HOW MANY PEOPLE LZ RECEIVE AN AWARD BASED ON THE PERCENTILE THAT THEY REACHED ON THEIR SCIENTIFIC REVIEW. SO WHEN WE SAY OKAY WE THINK THAT SCIENCE THAT IS SCORED IN THE 25TH PERCENTILE, TOP 75TH PERCENTILE IS VERY GOOD SCIENCE, SO PEOPLE WHO HAVE PERCENTILES LESS THAN 25, FOR ESI'S ACROSS ALL OF NIH, ABOUT 72% OF SUCH APPLICANTS WERE FUNDED, STHOS WHAT IS KNOWN FOR -- SO THIS IS WHAT IS KNOWN FOR EARLY DR. INVESTIGATORS AND THIS IS THE KIND OF THING WE WOULD DEVELOP FOR THE ALTHOUGH RISK INVESTIGATORS. WHEN YOU -- THE AT RISK INVESTIGATORS. WHEN YOU TAKE THE NUMBER OF 72% FOR ESI'S AND YOU SEE WHAT HAPPENS TO ALL OF NIH, NONES I APPLICATIONS OF PEOPLE BHO ARE AT RISK -- WHO ARE AT RISK, THE NUMBER OF PEOPLE AT RISK IS 61%, LOWER THAN FOR ESI, THE GOAL WOULD BE TO BRING SHOWS TO THE LEVEL OF ESI IF NOT HIGHER AND FOR THE REST OF NIH IS 60%. SO THAT WOULD BE THE ONE THING WE CAN FOLLOW FOR EXAMPLE AS A MEASURE OF HOW WE ARE DOING AND THIS IS VERY SIMILAR TO WHAT HAPPENED FOR EXAMPLE IN THE DEMOGRAPHIC TRENDS THAT ARE SEEN WHEN THE ESI DEFINITION WAS FIRST INTRODUCED AT NIH THAT YOU SEE AN INFLECTION POINT WHERE THE DROP IS BASICALLY STOPPED AND MAYBE INCREASED AS A RESULT. IN TERMS OF AWFUL THE HAVE MEASURES, OTHER EFFORTS SHOULD BE MONITORED SO THERE'S NO UN INTENDED CONSEQUENCE SAY ON SCIENCE OR THE TYPES OF PEOPLE WHO WANT TO RESEARCH OR SUSTAIN RESEARCH, DEMOGRAPHICS, ET CETERA, SO THERE IS GOING TO BE A NEED TO TRACK ALL THESE ESI'S AND AT RISK INVESTIGATORS ACROSS ALL THE INSTITUTES TO SEE WHO THEY ARE ACCIDENT HOW THEY DO AND WHAT IT IS T THE TOTALITY OF THE WORKFORCE. FINAL AM THE ISSUE OF PRODUCTIVITY, SO AGAIN THAT WAS A VERY GOOD FIRST STEP ON LOOKING AT BIBL GRAPHIC OUTPUT THAT IS CONTROLLED FOR THE TYPE OF SCIENCE AND SO ON AS THE ONE MEASURE OF PRODUCT ACTIVITY, WE RECOGNIZE IT'S NOT THE ONLY MEASURE THAT NEEDS TO PLAY INTO TH DISCUSSIONS, SO WE'RE CONTINUING TO DISCUSS WHAT ARE REALLY MORE HOLISTIC MULTIFACET ED APPROACHES THAT CAN BE APPLIED NOT TO AID GROUP OF PEOPLE, BUT TO THE INDIVIDUAL THAT GO BEYOND BIBL GRAPHIC OUT PUT, WHETHER IT'S PATENTS, TRAINEES, MENTORING OR CITIZENSHIP AT NIH OR CITIZENSHIP IN THEIR INSTITUTION , WHAT ARE SOME OF THOSE THINGS THAT ARE PRODUCTIVE , ARE ONE SUGGESTION TO RRMSZ PUT THAT INTO THE BIO SKETCH, SO THEY EMPHASIZE THEIR RECENT CONTRIBUTIONS TO SCIENCES AND THAT'S NOT JUST ABOUT PAPERS BUT ALSO ABOUT OTHER ACTIVITIES THEY MAY BE ENGAGED IN THAT CAN ALSO BE RE FLECTDZ IN A BIOSKETCH AND MAYBE THAT WOULD BE CONSIDERED AT A TIME OF PEER REVIEW AS AN INDIVIDUAL ASESSIONMENT OF THAT PERSON'S PRODUCT ACTIVITY. NEXT STEPTION WE'LL SPEND THE NEXT SIX MONTHS DEVELOPING THESE DRAFT RECOMMENDATIONS AND OF COURSE WE WELCOME YOUR FEEDBACK TODAY TO REALLY TRY TO MODEL THOSE IN A WAY THAT INCORPORATES YOUR IDEAS AND WE WANT TO RECEIVE INPUT FROM ADDITIONAL STAKEHOLDERS, WE'RE ACTUALLY QUITE BENEFITED BY THE PUBLICATION OF THE NATIONAL AKD IN HIS R MS. NGRI REPORT RECOMMENDATIONS AND WE'VE REVIEW ED THOSE CAN -- THE ACADEMIES. IT'S A HELPFUL REPORT, THERE'S A NOTCH THINGS THAT ARE RECOMMENDED THAT ARE APPLICABLE TO NIH, NOT ALL OF THEM R SOME OF THE THINGS ALIGNED WITH OUR RECOMMENDATIONS ARE THESE IDEAS THAT EARLY STAGE INVESTIGATORS TO MULTI-PI GRANTS SLUD NOT LOSE THEIR EI STATUS, WE WANT TO MAKE SURE THAT MANY PEER REVIEW IS STRATIFIED TO AGAIN HAVE PEOPLE IN THE SAME CATEGORIES WHEN THEY ARE BEING REVIEWED, EMPHASIZING RECENT CONTRIBUTIONS TO SCIENCE SO THAT PEOPLE DON'T LIVE OFF THEIR LAURELS IN A WAY BUT PEOPLE ARE BEING PRODUCTIVE IN THE IMMEDIATE PAST, THAT THE AT RISK INVESTIGATOR, THE RO1 SHOULD LAST AT LEAST FIVE YEARS TO ALLOW PEOPLE TO ESTABLISH A VIABLE RESEARCH PROGRAM AND THEN CENTRAL MECHANISM FOR EVALUATING IMPACTS, ALL THESE THINGS ARE BROUGHT UP IN THAT REPORT AND WE ARE COMPLETELY IN AGREEMENT. THERE'S THE NUMBER OF OTHER RECOMMENDATIONS THAT WERE MADE THAT FALL UNDER NIH PURVIEW. THERE'S ONE SUGGESTION TO LIMIT POSTDOCTORAL TRAINING TO FIVE YEARS, AGAIN SO THAT PEOPLE DON'T FEEL LIKE THEY'RE INDENTURED SERVANTS AT THE SERVICE OF A PI BUT THEY'RE REALLY BEING PROMOTED TO THE POINT OF HAVING AN INDEPENDENT FACULTY POSITION. THERE WAS ANOTHER SUGGESTION TO LIMIT POSTDOCTORAL SUPPORT ON RO 1'S TONAL THREE YEARS FOR THE SAME -- TO ONLY THREE YEARS FOR THE SAME PURPOSE, AND THERE WAS A RECOMMENDATION TO INCREASE BY SEVERAL FOLD THE USES OF F AND K AWARDS, WE WANT TO STUDY THAT AS WE BRING IN A LOT OF YOUNG PEOPLE BUT WE DON'T WANT TO JUST BRING PEOPLE IN FOR THE SAKE OF BRINGING THEM IN, WE WANT TO BRING THEM IN AND SUSTAIN THEM SO WE AGAIN NEED TO EVALUATE THE CARRYING CAPACITY OF THE SYSTEM BEFORE THIS RECOMMENDATION IS ISSUED. THERE'S A NUMBER OF OTHER RECOMMENDATIONS THAT THE NATIONAL ACADEMIES MADE THAT ARE REALLY OUTSIDE OF WHAT NIH CAN DO, SO THERE'S A NUMBER OF THINGS THAT YOU CAN READ HERE THAT WE DON'T HAVE THE ABILITY OR THE MANDATED TO BE ABLE TO DO THAT WITHIN NIH AND IT'S A LARGER CONVERSATION BY POLICY MAKE ERPZ. FUTURE DISCUSSION WILL ALSO INCLUDE TOPICS AS WHETHER THE SE SI OR AT RISK SUCCESS RATE SHOUD BE THE SAME OR MORE THAN IT IS FOR THE ESTABLISHED INVESTIGATORS, DO WE WANT TO TARGETED THAT, BASICALLY ACHIEVE THE SAME SUCCESS RATE AND THEN MODEL THE METRIC SO THAT HAPPENS OR DO WE NEED TO EVEN GO HIGHER. WE REALLY NEED TO CONTINUE TO LEARN FROM WHAT IS COMING OUT OF THE DIVERSITY WORKING GROUP SO ANY IDEAS ARE INCORPORATED INTO OUR REPORT. THEN THIS ISSUE THAT'S EMERGED RECENTLY WHERE THERE ARE SITUATIONS WHERE MAYBE THE SCIENCE THAT IS BEING DONE IS IN -- IS FUM EDDED BY SAY A FOR PROFIT COMPANY OF SOME KIND AND THEN THERE'S LIMITATIONS ON WHETHER THE POST-DOC OR TRAINEE WHO IS ENGAGE IN THAT SCIENCE CAN PUBLISH BASED ON LIMITATIONS PLACED BY THE FUNDING PERSON, THE FUNDING BODY FOR THAT PARTICULAR SORT OF WORK AND THEN WHAT CAN BE DONE TO MAKE SURE THAT THE TRAINEE IS PROTECTED IN SUCH A SITUATION. WE WANT TO DEVELOP RECOMMENDATIONS FOWZ TO REVIEW IN OUR FINAL REPORT THAT ARE SUSTAINABLE AND NOT JUST ACROSS IC'S OR INSTITUTIONS BUT REALLY THROUGH TIME, THE IDEA HERE IS NOT TO PUT IN A PATCH OR A STOPGAP MEASURE THAT IS GOING TO ADDRESS THE CONCERNS OF COMING FOR THE NEXT FIVE YEARS, IT IS SOMETHING WILL HAVE LAST LASTING IMPACT FOR THE INITIATIVES LIKE ESI HAS SHOWN TO HAVE. I WANTED TO THANK THIS DIVERSE AND CONGENIAL GROUP OF PEOPLE, REALLY THEY'RE VERY PASSIONATE, MANY OF THEM ARE IN THE GROUP, I WANT TO RECOGNIZE COMPALO IS HERE, AMY HERE, JOHN, LINDA, MIKE LAUER, LARRY, NICOLE AND GARY, THERE YOU GO, I SAW YOU EARLIER, AND OTHERS WHO COULDN'T JOIN US IN PERSON TODAY, BUT REALLY GREAT IDEAS AND IT'S AMAZING TO SEE HOW WE'VE ALL COALESCED INTO A COMMON VISION WITH DIFFERENT PARTS OF EXPERTISE. WITH THAT, I'LL BE HAPPY TO TAKE YOUR QUESTIONS. THANK YOU. >> Francis Collins, MD: THANKS, JOSE, FOR THAT VERY EFFECTIVE DESCRIPTION OF WHERE YOU ARE. AGAIN, THIS GIVES US A LITTLE MORE TIME TO DLIB RATE ABOUT THE DRAFT RECOMMENDATIONS, AND I WAS HOPING THIS WOULD BE A MOMENT THAT WE COULD DO SO AS YOU ALL THEN THINK ABOUT WHERE YOU WANT TO GET TO BY DECEMBER. START WITH ROY. >> THANKS, JOSE. VERY NICE PRESENTATION, AND KUDOS TO THE COMMITTEE. VERY THOUGHTFUL DELIBERATIONS. I WANT TO ASK YOU ABOUT YOUR COMMENT ABOUT FOCUSING ON THE INVESTIGATORS AND NOT THE PROJECT SO MUCH, AND I THINK YOU USED THE WORD BETHING ON THE INVESTIGATORS. SO FROM A PRACTICAL STANDPOINT, HOW DOES THAT PLAY OUT? I'M HAVING TROUBLE VISUALIZING WHAT THAT MEANS AND HOW YOU MITIGATE AGAINST MAYBE PERHAPS UNINTENDED POTENTIAL UNINTENDED CONSEQUENCE OF PERPETUATING THE STATUS QUO OR ADVANTAGING THOSE WHO ARE MOST WELL CONNECTED BY FOCUSING ON THE INVESTIGATOR AND NOT THE PROJECT. >> SO WHAT I MEAN BY THAT IS MORE OF A PHILOSOPHICAL APPROACH FOR THE PEOPLE AT RISK, SO THIS IS NOT FOCUSING ON THE INVESTIGATOR ACROSS ALL THE NIH FUNDING, THE IDEA IS ONCE YOU IDENTIFY PEOPLE AT RISK. >> OH, I GOT IT, OKAY, AS OPPOSED TO THE -- >> RIGHT. TO THE ENTIRE WORKFORCE. RIGHT. SO I THINK ONE EXAMPLE IS THE MYRA AWORD FROM NIGMS, THIS IS AN AWARD BY WHICH -- MAYBE JOHN CAN COMMENT MORE -- BUT PEOPLE APPLY AND THEN THEY'RE REALLY JUDGED ON THE POTENTIAL AND THE PROMISE AND NOT ONLY -- THE SCIENCE IS IMPORTANT AND THE SCIENTIST TO SCORE WELL, BUT REALLY THE IDEA HERE IS THAT WE WANT TO PROTECT PEOPLE BECAUSE PEOPLE ARE THE ONES WHO DO THE SCIENCE. >> THAT WAS A GREAT REPORT, AND I THINK THESE ARE GREAT RECOMMENDATIONS. SO IT STRIKES ME THAT THE MODELING PIECE OF IT IS CRITICAL , AND UNTIL YOU ACTUALLY HAVE A GOAL, THE QUANTITATIVELY DEFINED GOAL FOR WHAT YOU WANT THE DEMOGRAPHIC TO LOOK LIKE OF OUR WORKFORCE IN A WAY THAT MATCHES THE NATIONAL TRENDS IN RETIREMENT AGES AND WHEN PEOPLE ARE ENTERING AND NOT EVERYONE IS GOING TO STAY IN SCIENCE AND ALL OF THOSE PIECES, IT'S KIND OF GRASPING IN THE DARK AS FAR AS WHERE TO PUT THESE NUMBERS. AND I'M JUST CURIOUS, WHAT ARE YOUR THOUGHTS ABOUT LIKE HOW DO YOU ACTUALLY GO ABOUT EXECUTE OG THAT MODELING? IS THIS SOMETHING THAT WOULD BE OUTSOURCED OR WOULD BE DONE INTERNALLY OR HOW DO YOU THINK ABOUT THAT? >> THANK YOU. SO IN TERMS OF WE HAVE RECEIVED ABSOLUTE NUMBER GOALS. NOW WHERE THOSE NUMBERS CAME FROM, THEY'RE KIND OF ASPIRATION AL BUT THEY'RE NOT REALLY BASED AGAIN ON A REAL EVALUATION ON THE CAPACITY OF THE SYSTEM IN TERMS OF THE NUMBER OF PEOPLE THAT WE WANT TO BRING IN UNDER NGR I SO I COMPLETE AL AGREE THAT WE NEED TO HAVE THE MODELING TAKE PLACE. THERE ARE SOME PEOPLE ON THE PANEL WHO HAVE SOME EXPERTISE BUT I DON'T THINK WHO HAVE SUFFICIENT. SO WE PROBABLY IN THE NEXT FEW MONTHS WILL NEED TO OUTSOURCE AS YOU MENTIONED SOME EVALUATION OF WHAT NEEDS TORQUES GIVEN PROJECTIONS ABOUT BUDGET AND WHERE THINGS ARE HAPPENING TODAY , WHAT NEEDS TO HAPPEN. MOST LIKELY WE'RE GOING TO BE, THE MODELS WILL ASSUME A STABLE BUDGET AND SO TBL A ZERO SUM GAME BUT THE IDEA IS TO BALANCE THE WORKFORCE AND THE TRENDS WE'VE BEEN VERY CONCERNED ABOUT OVER THE PAST YEAR ARE SOMEWHAT REVERSED AS FAR AS THE MAKEUP DISTRIBUTION AND CAREER STAGE DISTRIBUTION OF THE WORKFORCE. THAT WILL PROBABLY BE WHAT ENDS UP HAPPENING WITHIN THE FIXED CONSTRAINTS OF WHAT WE HOPE TO BE AT LEAST A STABLE BUDGET. >> WOULD YOU SAY A LITTLE MORE ABOUT WHAT'S ALREADY BEEN DONE IN THAT SPACE. MIKE LEVITT HAS THIS PAPER WHICH IS IN PNAS WHICH DID ATTEMPT AT THAT KIND OF MODELING AND MADE SOME VERY SPECIFIC RECOMMENDATIONS ABOUT EARLY STAGE INVESTIGATORS WHICH TURNED OUT TO MESH QUITE NICELY WITH WHAT NIH WAS COMING DOWN ON WITHOUT REALIZING WHY IT WAS GOING TO BE SUCH A GOOD FIT AND OF COURSE YOU HAVE BRUCE WEINBERG ON THE GROUP. >> YES, BOTH OF THEM HAVE GREAT EXPERTISE. >> WOULD THEY AGREE THERE NEEDS TO BE SOME ADDITIONAL WORK DONE ON THIS BY SOME SORT OF OUT SOURCED EFFORT? >> WELL, THEY HAVEN'T SPECIFICALLY SAID OUTSOURCE IT, BUT THEY ARE THE MOST EXPERT ALONG WITH MIKE IN THIS SPACE IN THE GROUP, AND I THINK THEY CONCEDE THAT THEY COULD USE SOME HELP, BUT MIKE, YOU MAY WANTED TO -- >> SO ACTUALLY THERE HAVE BEEN SOME EFFORTS IN THE PAST FEW YEARS TO MODEL THE BIOMEDICAL RESEARCH WORKFORCE. WE DID AT ONE POINT WORK WITH A VERY WELL-KNOWN OUTSIDE CONTRACTOR TO WORK ON THIS. PART OF THE TRICK TI CART IS THAT IT -- TRICKY PART IS THAT THE NIH ECOSYSTEM IS VERY COMPLEX, WE HAVE A MIX OF LARGE PROJECTS, SMALL PROJECTS, CONTRACTS, GRANTS, TRAINING PROGRAMS, RESEARCH PROGRAMS, RESEARCH INFRASTRUCTURE AND ALL THAT HAS TO BE SOME HOW FIT IN INTO THINKING ABOUT WHAT YOUR GOALS ARE. THIS IS SOMETHING THAT WE CAN CONTINUE TO WORK ON. PROBABLY BETWEEN BRUCE AND MICHAEL, THEY HAVE COME UP WITH SOME NUMBERS WHICH ARE SEEM TO BE REASONABLE ESTIMATES, AND IT WAS NICE TO SEE, IT WAS COMFORT ING TO SEE THAT THOSE NUMBERS WERE CLOSE TO THE TARGET NUMBERS THAT WE'VE COME UP WITH AT LEAST IN THE INTERIM. >> THANK YOU. THAT'S REALLY GOOD WORK BY THE WORK GROUP. I HAVE A QUESTION ABOUT THE FOURTH POINT ABOUT STABILIZATION OF THE WORKFORCE IN GENERAL BECAUSE OBVIOUSLY I THINK ALL THESE IDEAS ARE ABSOLUTE UNTIL LINE WITH WHAT WE'VE BEEN TALKING ABOUT AND I THINK WILL GET US THERE, BUT YOU JUST DON'T WANT TO PUSH THE CLIFF FURTHER FORWARD AT SOME LEVEL, AND I KNOW THIS HAS BEEN RAISED IN SOME OF THE PAST MEETINGS, AND I WANT TO KNOW WHETHER THERE WAS MORE DISCUSSION ABOUT WHAT ARE THE SORT OF THE INSTITUTIONAL CONTRIBUTIONS TO THE EQUATION? I KNOW WE KNOW THAT WE'RE JUST OBVIOUSLY HERE TO ADVISE NIH, BUT AT THE UNDERSTAND OF THE DAY FORT ECOSYSTEM TO BE STABLE, THAT'S A DELTA THAT IS CRITICAL, AND, YOU KNOW, CERTAINLY AT NIH MECHANISMS EARLY ON IN THE PATHWAY, INSTITUTIONAL COMMITMENT IS VERY IMPORTANT AND HAS TO BE DEMONSTRATED, SO IS THERE A ROLE FOR THAT IN TERMS OF LEVERS? RIGHT NOW THE ONLY REAL I WOULD SAY REQUIREMENT FOR THAT IS THE NIH SALARY CAP. >> RIGHT. >> SO WAS THERE ANY DISCUSSION ALONG THESE LINES? >> THERE WAS A GREAT DISCUSSION, A LOT OF DISCUSSION, A LOT OF IDEAS. NONE OF US ARE ATTORNEYS, SO THERE'S A LOT OF THINGS THAT GET THROWN UP AND THEN CAN LAYER LARRY IS SORT OF THE PERSON WHO NEEDS TO DEAL WITH OKAY, CAN WE DO SOMETHING WITHIN THE BOUNDARIES OF U.S. LAW? SO WE STRIVE TO DO THAT SO THERE'S BEEN CONSULTATIONS WITH OCG THAT TELLS US THIS IS NOT SOMETHING THAT NIH HAPPENS THE PURVIEW TO DO AND THINGS THAT HAVE BEEN TRIED MANY TIME IN THE PAST, WE ARE TOLD THIS IS NOT SOMETHING, VERY CREATIVE IDEAS THAT IT NEEDS TO BE DEMANDED, FOR EXAMPLE, HOW MUCH MONEY CAN COME FROM NIH TO SUPPORT A PERSON'S SALARY, THINGS OF THAT SUPPORT HAVE BEEN CONTEMPLATED OFTEN AND MANY THINGS ARE NOT REALLY FEASIBLE SO THE SPACE WE CAN ACHIEVE THE MOST I THINK IN TERMS OF GETTING INSTITUTIONS TO PITCH IN IS WHEN IT COMES TO THE YOUNG PEOPLE AND THE DIVERSITY AND WHAT IS THE INSTITUTION DOING TO FAVOR THE RETENTION AND RECRUITMENT OF JUNIOR PEOPLE AND WHAT IS THE KIND OF ENVIRONMENT THAT IS BEING FOSTERED. SO TO THE EXTENT THAT AN INSTITUTION MAY SEE THAT THIS IS SOMETHING THEY'RE GOING TO BE JUDGED ON AND THAT REQUIRES HARD MONEY SUPPORT FOR THE RECRUITMENT OF THESE PEOPLE, THEY MIGHT BE ABLE TO CONTRIBUTE TO CHANGING A LITTLE BIT OF THE CULTURE AND SAYING IF I REALLY NEED TO DEMONSTRATE RECRUITMENT OF X NUMBER OF UNDERREPRESENTED MIERNGHTS OR WOMEN OR PEOPLE AT RISK, YOU KNOW -- MINORITIES OR WOMEN OR PEOPLE AT RISK WHAT, AM I SHOWING IN THEEFNT. SO THE FOCUS ON TRAINING AND IN CAREER AWARDS AS A WAY TO TRY TO FOSTER INSTITUTIONAL CULTURAL CHANGE IS ONE THAT WE'RE EXCITED ABOUT. MANY OF THE OTHER THINGS I THINK ARE COMPLEXES AND DIFFICULT TO IMPLEMENT BY A FUNDING AGENCY, WE'RE NOT ENFORCERS. WILL. >> I'LL ADD THAT THE ENGINEERS ON THE COMMUNITY WHO ARE USE TO DO INTERACTING WITH NSF AND SOME OTHER AGENCIES, THEY HAVE SALARY CAPS ON WHAT YOU CAN CHARGE PER YEAR, AN AMOUNT THAT YOU CAN CHARGE PER YEAR SO THE SALARY CAP I THINK HAS NOT COMPLETELY BEEN DEAD AS PINT OF DISCUSSION. THE WAY THAT NIH SETS A SALARY CAP IS DIFFERENT THAN OTHER FEDERAL AGENCIES. THE REASON IT CAME UM IS THAT OFTEN ENGINEERING INSTITUTIONS DO PUT A LOT MORE INSTITUTIONAL SUPPORT INTO THE TENURE PROCEED PROMOTION, IT HAS TO DO WITH THE DIFFERENCES IN TRAINING, BUT THERE MAY BE STILL YET LESSONS WE COULD LEARN FROM THAT AS FAR AS INSTITUTIONAL SUPPORT AT THE STAGE OF WHEN YOU'RE FINISHING YOUR FIRST RO1 AND MOVING UP MAYBE. BUT THERE IS STILL A LOT OF DISCUSSION ABOUT THAT. >> SO FIRST TO REASSURE OCG THAT I'M NOT AN ATTORNEY. [LAUGHTER] DAVID DR. NEARLY HAD A CARDIAC DEFENSE. BUT YOU'RE SITTING NEXT TO A CARDIOLOGIST YOLINGS, SO IT'S OKAY. -- CARDIOLOGIST, SO IT'S OKAY. AND MIKE IS RIGHT THERE TOO. IS THE SENSE OF THE COMMITTEE THAT WE ARE HEADING IN THE RIGHT DIRECTION? BECAUSE OBVIOUSLY THIS IS A LOT TO GET YOUR ARMS AROUND AND THERE'S BEEN JUST A MASSIVE AMOUNT OF DISCUSSION WITHIN THE COMMUNITY AND WE'VE REALLY HAD THE ADVANTAGE OF AN EXTRAORDINARY OF DIVERSITY OF OPINION ON THE COMMITTEE, WHICH I THINK HAS BEEN REALLY HELPFUL, IT'S DRIVEN ME A LITTLE NUTTY AT TIMES BUT IT'S BEEN VERY, VERY HELPFUL, BUT WHAT'S THE SENSES OF THE GROUP? ARE WE IN THE RIGHT DIRECTION? ARE WE RIDING OFF THE TRACK? WHAT'S HAPPENING? >> SO I WILL COMMEND JOSE, IT'S BEEN AN AMAZING LEADER OF THIS TOGETHER WITH YOU, YOU'VE DONE A GREAT JOB CORPS RESIDUALING THESE. THE COMMENT THAT MIKE LAUER MADE IS SO TRUE ON HOW MUCH OF THE COMPLEXITY OF THE WHOLE NIH ENTERPRISE DO YOU CAPTURE BECAUSE THE WAY THAT SCIENCE IS BEING DONE IS CHANGING AND WE FOCUS ON RO1'S WHICH ARE IMPORTANT BUT THERE'S OTHER THINGS AARE SHIFTING IN THE WAY NIH FUNDS MULTI--INVESTIGATOR GRANTS THAT MIGHT BE HELPFUL TO JUNIOR PEOPLE JUST AS AN INFORMATIVE THINGS WAY, THIS IS HOW THINGS HAVE SHIFTED AND IT'S BEEN DIFFICULT TO GET THAT OUT OF NIH DATABASE. ONE THING THAT'S COME OUT IS A DISCUSSION ABOUT WAYS WE MIGHT GET THE EX-TERNLG COMMUNITY ON A LONGER TIME -- EXTERNAL COMMUNITY ON A LONGER TIME SCALE THAT WE COULD SEE WAYS RF LETTING THE EXTERNAL COMMUNITY LOOK AT NIH DATA TO DO PREDICTIONS THAT MIGHT NOT DMOM OUR REPORT BUT THAT COULD BE SUPER BENEFICIAL IN THE FUTURE BECAUSE INFORMATION IS POWER AND WHEN YOUNG INVESTIGATORS SEE THE WHOLE SPECTRUM OF THINGS AND TRENDS IT COULD BE HELPFUL. >> I THINK QUALITATIVELY IT SEEMS LIKE IT'S GOING IN EXACTLY THE RIGHT DIRECTION. WHAT I AM NOT CERTAIN ABOUT ARE THE ECONOMIC MODELS THAT ARE GOING TO SUPPORT THIS, AND I DON'T KNOW IF THAT'S PART OF THE REMIT OF THE COMMITTEE IS TO ACTUALLY BEGIN ON GET TO THAT LEVEL OF DETAIL SO WE UNDERSTAND THE IMPLICATIONS FOR THE OVERALL NIH BUDGET GOING FORWARD AND FOR THE IC'S. >> MIKE CAN SAY IT MORE ELOQUENT LY THAN I CAN, BUT THERE ARE SO MANY DIFFERENT BUSINESS MODELS AT INSTITUTIONS AROUND THE COUNTRY, WHAT WORKS FOR ONE WON'T WORK FOR THE OTHER, AND YOU CAN'T SATISFY EVERY BUSINESS MODEL. YOU CAN TRIERKS BUT YOU REALLY CAN'T. AND THERE'S A RANGE OF THE COMPLETELY SOFT MONEY INSTITUTION, WHICH MANUFACTURE YOU ARE FAMILIAR WITH, TO AN INSTITUTION WHERE THERE ARE MANY MORE HARD RESOURCES. AND IT WOULD BE NICE TO SAY TO EVERYBODY OKAY, YOU ALL HAVE TO BECOME HARD MONEY INSTITUTIONS, BUT THAT'S NOT REALISTIC. SO, YOU KNOW, HOW DO WE STRIKE THAT BALANCE? AND SO MANY OF OUR YOUNG PEOPLE ARE IN EITHER QUASI OR COMPLETELY SOFT ENVIRONMENTS, AND IF WE'RE NOT CAREFUL, YOU KNOW, THE UNINTENDED CONSEQUENCESES YOU CAN LOSE THEM RIGHT? >> SO REMEMBER THE CURVES WHERE WE SAW THE ESI'S COMING DOWN, DOWN, DOWN, THEN IN 2007, 2008, THAT CURVE, THERE WAS INFLECTION IN THE CURVE AND THEN THEY WERE STABLEIZED AND MAYBE GO UP A LITTLE BIT. AFTER THAT HAPPENED, THEN THE VERY SENIOR PEOPLE CONTINUED TO DO BETTER AND BETTER AND THEN THE DRA MACTD EFFECT AND INTENDED EFFECT WAS THAT THE MID CAREER PEOPLE MANY OF WHOM CAME IN DURING THE DOUBLING GO DOWN DRAMATICALLY SO YOU CAN SORT OF EXPECT THAT THIS IDEA BY TARGETING PEOPLE AT RISK AS OPPOSE TO DO A SPECIFIC GROUP OF PEOPLE IN ONE STAGE OF THEIR CAREER, TARGETING PEOPLE AT RISK YOU WOULD STABILIZE MERITORIOUS INVESTIGATORS WHO ARE GOING TO BE LEAVING THE SYSTEM UNLESS WE DO SOMETHING FOR THEM. SO WE HOACH TO SEE THE CURVES GO IN THE RIGHT DIRECTION WHERE THE MID CAREER PEOPLE STABILIZE, YOU CAN IMAGINE MAYBE IT COMES AT THE COST OF SOME OF THE MORE SENIOR PEOPLE WHRO ARE BEING MAYBE MORE PRODUCTIVE, BUT BY NOT GOING AFTER ONE SPECIFIC GROUP WE'LL ANSWER THE CHARGE WE ARE GIVEN WHICH IS HOW DO WE STABLIZE THE WORKFORCE AND PROTECT YOUNG GOOD PEOPLE IN SCIENCE AND WHO ARE GOING TO BE OUT OF LUCK UNLESS WE DO SOMETHING FOR THE TOP 25%. SO I WILL HAVE TO BE MONITORING ON A REGULAR BASIS AND SEE WHAT IS HAPPENING TO THIS CURVE, BUT I THINK DEDICATED INTERVENTION OF THIS TYPE WILL DEFINITELY BRING THE FUNDING RATE YOU WERE FOR THOSE PEOPLE AND SO THAT WILL HAVE GOOD EFFECTS ON THEM, AND THEN WHAT IS IT DOES ON THE REST. NIH PORTFOLIO WE'LL HAVE TO MONITOR. >> SO IT MIGHT BE HELPFUL FOR AC D TO HEAR WHAT WE'VE BEEN TRYING TO DO WHILE WAITING FOR THE FINAL RECOMMENDATION PS FROM THE WORKING GROUP, RECOGNIZING THAT EVERYBODY AGREES WE HAVE A SERIOUS ISSUE ABOUT EARLY STAGE INVESTIGATORS AND ALSO INVESTIGATORS AT RISK. MIKE LAUER HAS BEEN VERY MUCH ENGAGED IN TRYING TO LEAD THIS ENTERPRISE ALONG WITH LARRY AND ME AND ALL THE INSTITUTE DIRECTORS HAVE BEEN DEEPLY ENGAGED IN THINKING THIS THROUGH IN TERMS OF WHAT WE COULD DO RIGHT AWAY. SO MAYBE YOU WANT TO SUMMARIZE WHERE WE ARE WITH THAT IN THE CURRENT FISCAL YEAR. >> SO FOR FISCAL YEAR '18, WE'RE SPECIFICALLY FOCUSING ON TWO AREAS. ONE IS WE WOULD LIKE TO INCREASE THE NUMBER OF ESI'S WHO ACHIEVE FUNDING. LAST YEAR IT WAS ABOUT 1040, SOMETHING LIKE THAT, AND WE WOULD LIKE TO GET IT TO ABOUT 1100. THAT WOULD BE THE MOST NUMBER OF ESI'S EVER FUNDED IN ANY GIVEN FISCAL YEAR SINCE THE TIME OF THE DOUBLING. SOILY WE HAVE ALREADY LOOKED, FORTUNATELY ALTHOUGH THIS TIME OF YEAR, ALL THE APPLICATIONS HAVE COME IN, THEY HAVE BEEN SCORED, THERE ARE WELL OVER 1100 ESI'S WHO HAVE AT LEAST ONE APPLICATION THAT HAS RECEIVED A GOOD SCORE, SO WHAT WE HAVE DONE IS WE HAVE PRODUCED DATA FOR THE ICE'S INDICATING WHO THESE ESI'S ARE AND WE'RE KEEPING A CLOSE TRACK TO SEE WHAT'S GOING ON. THE SECOND AREA THAT WE'RE FOCUSING ON, THIS IS AGAIN VERY MUCH IN LINE WITH WHAT JOSE HAS BEEN TALKING ABOUT, IS IDENTIFYING INVESTIGATORS WHO ARE AT RISK. SO WE ARE LOOKING FOR ESTABLISHED INVESTIGATORS WHO AS BEST AS WE CAN TELL IF THEY ARE NOT -- SO THERE ARE TWO THINGS. ONE IS THAT THEY HAVE TURNED IN AT LEESES ONE HIGH QUALITY GRANT THIS YEAR -- AT LEAST ONE HIGH QUALITY GRANT THIS YEAR, AND AS BEST AS WE CAN TELL, IF THEY ARE NOT FUNDED THIS YEAR, THEY WILL LOSE ALL FUNDING NEXT YEAR. NOW, OF COURSE WHAT WE ALSO DO IS WE LOOK AT THE OTHER SUPPORT THAT THEY MAY RECEIVE OUTSIDE OF NIH, SO WE WOULD TAKE THAT INTO ACCOUNT AS WELL. WHAT WE ARE DOING IS WE ARE FLAGGING THOSE INDIVIDUALS AND WE'RE BRINGING THOSE TO THE ATTENTION OF PROGRAM STAFF AND I C DIRECTORS TO SAY HERE ARE A GROUP OF ESTABLISHED INVESTIGATORS, THEY APPEAR TO BE DOING GOOD WORK, THEY HAVE TURNED MANY A HIGH QUALITY GRANT , AND YOU SHOULD KNOW THAT THEY ARE AT RISK FOR LOSING ALL FUNDING AND TAKE A LOOK AT WHAT'S THERE AND YOU MIGHT DECIDE THAT THIS MIGHT BE WORTH FUNDING. >> AND WHERE IS THE MONEY GOING TO COME FROM? OF COURSE IT'S GOOD THAT WE'RE DOING THIS IN FY18, IN A YEAR WHERE WE HAVE THIS EXCEPTIONALLY POSITIVE BUDGET FROM THE CONGRESS, WHICH MEANS ALL IC'S HAVE A LITTLE OVER 5% AND THEN THERE ARE ADDITIONAL AREAS THAT ARE OF EMPHASIS THAT BRING US UP TO 9%. THIS WOULD BE A LOT HARDER IF WE WERE NOT IN A CIRCUMSTANCE THAT WE ARE. BUT OBVIOUSLY THERE ARE STILL SOME TRADE-OFFS, YOU ALL WILL REMEMBER AT ONE POINT, WE THOUGHT THAT WOULD BE SOMETHING THAT WE COULD IDENTIFY ADDITIONAL FUNDS BY LOOKING AT THAT CURVE OF PRODUCTIVITY FROM THE MOST HIGHLY FUNDED INVESTIGATORS, THAT TURNED OUT NOT TO BE A TERRIBLY POPULAR IDEA, AND SO INSTEAD WE'RE LEAVING THIS UP TO THE INSTITUTE DIRECTORS TO FIGURE OUT HOW TO FIND THE FUNDS TO DO THIS BASIS SED ON WHAT THEY SEE AS THE HIGHEST PRIORITIES IN THEIR PORTFOLIO. AGAIN, I WANTED ACD TO RECOGNIZE , WE'RE NOT WAITING UNTIL DECEMBER TO BEGIN TO TRY TO IMPLEMENT SOME PILOT EFFORTS HERE AND TO SEE HOW THEY LOOK, AND RIGHT NOW IT LOOKS, AS YOU SAID, LIKE WE MAY HAVE THE LARGEST NUMBER OF EARLY STAGE INVESTIGATORS FUNDED IN FY18 THAT WE'VE HAD IN 15 YEARS. THAT WOULD BE A GOOD THING. DAVID? >> SO THANKS FOR THE EDUCATION, FIRST, BECAUSE THIS IS AN AREA I HAVEN'T THOUGHT ABOUT, AND I FOUND THE PRESENTATION VERY USEFUL FOR THAT. REINFORCING A COUPLE POINTS AND THEN BUILDING ON THEM, THE POINT ABOUT WE HAVE TO KNOW WHAT WE WANT THE ANSWER TO LOOK LIKE, AND I'VE HEARD A COUPLE OF DIFFERENT THINGS THAT ARE SIMILAR BUT DIFFERENT. IT'S LIKE THE PROBLEM IS THE ESI CURVES, BUT WE DON'TMENT TO JUST FIX ESI'S, WE WANT TO FIX ESI AND AT RISK. THOSE ARE PROBABLY ALL TRUE STATEMENTS, BUT IF YOU WANTED TO DO AN OBJECTIVE MEASURE A YEAR AFTER RECOMMENDATIONS WENT IN PLACE, I DON'T KNOW WHICH OF SHOWS ARE THE CURVES THAT WE WANTED TO LOOK ALTHOUGH. -- TO LOOK AT. THERE WAS ONE POINT WHERE YOU SAID THIS CURVE MOVED IN THE GOOD DIRECTION. WELL, THAT MEANS WE HAVE A SENSE OF WHAT GOOD IS, RIGHT? WE KNOW IT WHEN WE SEE IT. BUT I HOPE, AND FORM THIS AS A QUESTION S THE INTENT THAT THE FINAL RECOMMENDATION WILL BE SOMETHING THAT IS OBJECTIVELY MEASURABLE, WHAT IS THE OUTCOME, WHAT IS THE THING WE'RE MEASURING AND THE OUTCOM WE'RE LOOKING FOR ON THAT THING? BECAUSE OTHERWISE WE'RE REARRANGING, YOU KNOW, AND JUST REARRANGING CHAIRS AND YEAH THE GRAPH WE CARE ABOUT WILL BUMP UP AND SOME OTHER GRAPH AND THEN IN TWO YEARS WE'LL FORM A COMMITTEE TO JUST THAT ONE. >> SO YOU'RE CORRECT, AND THIS IS WHAT THE GROUP HAS BEEN STRUGGLING WITH. EVEN THIS THOUGH WE DO HAVE ONE WORKFORCE ECONOMIST AND ONE PERSONAL WHO CERTAINLY HAS THE CRED NOT OF DOING THAT TYPE -- CREDIBILITY OF DOING THAT TYPE OF ANALYSIS ON THE COMMITTEE, EVEN FOR THEMENTS A COMPLICATED QUESTION AND PROBLEM, IN PART BECAUSE OF THE HETEROGENEITY OF THINGS WE DO AND ALSO OF THE WORKFORCE AND WHERE THEY WORK, BUT AS FRANCIS HAS SAID, WE HAVEN'T SAT BACK IDLY AS THE GROUP TRIES TO WORK THROUGH THINGS, WE IN FACT ARE PILOTING THINGS WHICH ARE CONSONANT WITH WHAT THE WORKING GROUP HAS BEEN IN A SORT OF PRELIMINARY WAY RECOMMENDING, SO WE ARE TRYING SOME THINGS, BUT IT'S MORE ITERATIVE RATHER THAN OKAY HERE IS THE PLAN, HERE IS THE TARGET AND SO FORTH. SO THE HOPE WOULD BE TO GET TO THAT EXACT THING, TO OR PARTICULAR LATE CLEARLY WHAT THE GOAL OR GOALS, BECAUSE DR. DOUBT THERE WILL ONLY BE ONE, ARE, I DON'T KNOW IF WE'LL SUCCEED, BUT WE CERTAINLY CAN PUT OUR EFFORTS INTO TRYING TO DO THAT. >> TO CLARIFY, YOU WERE SAYING THE FOCUS ON ESI'S OR PEESM AT RISK. SO THERE WAS INTERVENTION MADE FOR ESI'S THAT WAS WE THINK A GOOD INTERVENTION IN THAT IT STABLEIZED THE CURVE AND IT'S BEEN A GOOD THING FOR NIH. THE QUESTION IS ONCE THOSE PEOPLE ARE FUNDED INITIALLY, WHAT HAPPENS TO THEM AFTERWARDS? THOSE ARE THE PEOPLE WE'RE TRYING TO REALLY PROTECT AND RESCUE WITH THIS ALTHOUGH RISK DEFINITION. SO I THINK THE FOCUS REALLY FROM OUR STANDPOINT IS ON AT RISK. OF COURSE ESI CAN ALWAYS BE IMPROVED AND THERE'S INITIATIVES TO TRY TO IMLEUF TRK BUT THAT'S ALREADY A GROUP THAT'S BEEN RECOGNIZED AND PROTECT AND NOW WE WANT TO MAKE SURE THAT THEY ARE PROTECTED NOT ONLY FOR THE FIVE OR SIX YEARS THAT ESI BUT THEY ARE PROTECTED THROUGHOUT THEIR CAREER, SO THE FOCUS WILL BE ON AT RISK. >> THANK YOU. CAN ONE OTHER SMALL POINT IS THINKING ABOUT SOME OF THE IMPLEMENTATION YOU WERE TALKING ABOUT, HOW TO MEASURE T YOU'VE PROBABLY THOUGHT ABOUT IT ALREADY, BUT IF YOU CODIFY A THING, A CATEGORY OF AT RISK, THE EASIEST WAY TO MEASURE IT IS LET PEOPLE FLAG I'M AT RISK WITH SOME WELL DEFINED THING THAT HAS TO BE TESTED, BUT REVERSE ENGINEERING, DO YOU HAVE OTHER SOURCES OF QUALIFYING FUNDING SEEMENTZ APRIL LOT HARDER -- SEEMS A LOT HARDER THAN -- >> YOU'RE ABSOLUTELY RIGHT. WE ALSO GET THAT DATA ANYWAY, SO WE KNOW ABOUT NIH DATA BECAUSE THAT'S ALREADY IN OUR SYSTEM, BUT WE KNOW ABOUT OTHER SUPPORT BECAUSE EVERYBODY HAS TO TELL US WHAT THEIR OTHER SUPPORT IS, THAT'S A REQUIREMENT. IT'S A REQUIREMENT ON THE BIO SKETCH, IT'S A REQUIREMENT FOR JUST IN TIME AND IT'S A REQUIREMENT FOR PRIVACY REPORT SO THAT'S ANOTHER PLACE WE CAN LOOK. NOW, WE'RE ALSO DEVELOPING A RELATIONSHIP WITH LZ ORCID WHICH WE HOPE WILL BE ANOTHER WAY IN WHICH WE CAN HAVE A MUCH BETTER SENSE AS TO WHERE SCIENCE SITS WITHIN THE ECOSYSTEM IN AN OBJECTIVE AND UNBIASED WAY. >> ROY? >> SO I THINK IDENTIFYING THESE ALTHOUGH RISK INVESTIGATORS AND SUPPORTING THEM IS A GREAT IDEA. A LOT OF INSTITUTIONS HAVE GREAT SUPPORT AND OTHER KINDS OF MECHANISMS FOR SUPPORTING. THE FIRST THING I THOUGHT ABOUT WHEN YOU SAID THIS IS MAYBE I CAN DEEP CREASE MY INSTITUTIONAL SUPPORT THAT I GIVE TO THESE PEOPLE AT NIH. [LAUGHTER] SO HOW DO YOU DO THIS AND SUPPORT THESE INVESTIGATORS FROM THE NIH RLSZ PERSPECTIVE WHILE AT THE SAME TIME NOT DIS INCENTIVIZING INSTITUTIONS? >> WE INVITE PRESIDENTS OF UNIVERSITIES TO THE COMMITTEE. [LAUGHTER] AND WHEN THEY RELAY THIS TYPE OF INFORMATION, WE FLAG THAT INSTITUTION. [LAUGHTER] NO, RIGHT, THANK YOU, BECAUSE IT'S REALLY A CRUCIAL POINT THAT YOU'RE RAZORING AND IT GETS BACK TO SORT OF THE HARD RESOURCES AND SO FORTH. FRAK AND THAT'S WHY IT HAS TO BE A PARTNERSHIP AND THAT'S WHY IT HAS TO BE A DIALOGUE AND THAT'S WHY WE CAN'T MAKE THE MEANINGFUL CHANGES THAT ARE REQUIRED JUST IN THIS ROOM. WE NEED TO ENGAGE YOUR COLLEAGUES, UNIVERSITY PRESIDENT S AND SO FORTH BECAUSE THERE'S ONLY SO MANY DOLLARS AND WE WANT TO BE ABLE TO MAXIMIZE THE USE BECAUSE AT THE END. DAY WE ALL WANT A STABLE BIOMEDICAL RESEARCH WORKFORCE, AND I DON'T THINK ANYBODY DISAGREES WITH THAT. AND AGAIN, YOU KNOW, EVERYBODY NEEDS MORE RESOURCES, SO HOW BEST, TURN BACK TO YOU, HOW BEST TO HAVE THAT DIALOGUE WITH UNIVERSITY PRESIDENTS AND THEIR STAFF TO WORK THROUGH THIS IN A WAY THAT WOULD BE MEANINGFUL AND HELPS EVERYBODY, THAT HELPS THE ECOSYSTEM. >> SO ROY, AS I THINK ABOUT THE MASS GENERAL PROGRAM FOR BRIDGE FUNDING FOR PEOPLE WHO SCORED WELL BUT DID NOT GET FUNDED, HOW WOULD THIS INITIATIVE AFFECT THAT PROGRAM? WELL, WHAT WOULD HAPPEN IS THERE WOULD BE A NUMBER OF PEOPLE AT RISK WHO MIGHT GET FUNDED WHO WOULDN'T HAVE OTHERWISE, SO WE WOULD RESCUE A FEW OF THEM, BUT THERE WILL STILL BE A NUMBER OF PEOPLE WHO COME CLOSE TO GETTING FUND AND HAD WHO ARE NOT. SO I CAN'T IMAGINE THAT THERE WOULD BE REALLY ANY DECREASE IN MY INSTITUTION'S APPLICATIONS FOR BRIDGE FURNGD, INTERNAL AND BRIDGE FUNDING FOR THAT CATEGORY OF PEOPLE WHO RECEIVED THE SCORE IN THE 25TH PERCENTILE BUT RNLT GETTING FUNDED. WE MAY RESCUE A FEW OF THOSE PEOPLE BUT THE MAJORITY WILL STILL NEED INSTITUTIONAL SUPPORT TO CARRY THEM TO THEIR NEXT APPLICATION. SO I DON'T THINK OUR PROGRAM WILL BE REALLY DRAMATICALLY AFFECTED BY THIS KIND OF MEASURE A FEW MORE PEOPLE WILL BE RESCUED, WHICH IS THE OVERALL INTENT ZOONG I DIFFERENT INSTITUTIONS SUPPORT THEIR INVESTIGATORS IN DIFFERENT WAYS, THOUGH. I'M PRELT TILL SURE THAT WE WOULD NOT ALLOW A PROMISING YOUNG INVESTIGATOR WHO IF THEY DIDN'T GET A GRANT WOULD SOMEHOW LEAVE TO LEAVE. WE WOULD INVEST IN THAT INVESTIGATOR. ON THE OTHER HAND, IF I THINK THAT NIH WILL DO T I MAY INVEST THOSE DOLLARS ELSEWHERE, I AGREE WITH YOU, LARRY, I AGREE IT'S GOT TO BE A PARTNERSHIP AND WE HAVE TO SOMEHOW ENGAGE THE UNIVERSITY COMMUNITY TO BE A PARTNER IN THIS. >> MIKE AND HIS COLLEAGUES AND MANY OF THE IC DIRECTORS REACH OUT TO THE UNIVERSITY COMMUNITY ALL THE TIME BUT I THINK YOUR COMMENTS, AND I KNOW PARTLY TONGUE-IN-CHEEK, I CAN SAY THAT BECAUSE OF MY PROFESSION. [LAUGHTER] BUT YOUR COMMENTS I THINK UNDER SCORE THE NEED TO TAKE THIS TO THE HIGHEST LEVELS OF UNIVERSITY LEADERSHIP, YOU KNOW, TO REALLY HAVE A MEANINGFUL DISCUSSION ABOUT THIS SO THAT WE CAN ALL WORK TOWARDS WHAT IS CLEARLY A COMMON GOAL. >> I WANT TO INVITE ANY OTHER MEMBERS OF THIS WORKING GROUP WHO ARE NOT AT THIS TABLE BUT WHO ARE IN THE ROOM IF THEY WANT TO ADD OTHER COMMENTS TO THE DISCUSSION WE'RE HAVING HERE BEFORE WE MOVE ON TO THE NEXT TOPIC. SO THOSE OF YOU WHO HAVE BEEN PARTICIPATING IN THIS DEBATE WITH JOSE AND LARRY AND OTHERS H >> AMY. >> AMY, CAN YOU COME TO THE TABLE AND TURN ON ONE OF THE MIC S SO PEOPLE CAN HEAR? >> I'M AMY ELLIOT. ONE OF THE THINGS I'VE OBSERVED AS PART OF THIS WORKING GROUP THAING HAS BEEN HIGHLIGHTED IN DIFFERENT WAYS BY SEVERAL OF YOU DURING THE Q & A HERE IS THE IMPORTANCE OF HAVING HARD DATA FROM THE INSTITUTIONS THAT ARE NOT NIH. IN TERM OF THE THINGS WE WOULD LIKE TO DO FOR MODELING THE WORKFORCE, IN TERMS OF FIGURING OUT WHAT THE RELATIONSHIP IS, WHAT ARE PTD BUY-IN HAS BEEN THAT ARE NOT NIH AND STABILIZING THE WORKFORCE, THIS IS SOMETHING WHERE WE'RE LIMITED FROM WHAT WE CAN DO WITHIN A WORKING GROUP OR WITHIN NIH. SO TO THE EXTENT THAT WE CAN GET THE ACADEMIC INSTITUTIONS THAT HOUSE ALL OF OUR FACULTY TO PARTICIPATE IN THIS CONVERSATION , THAT WOULD BE EXTREMELY HELPFUL. THERE IS A COALITION OF LIKE NINE INSTITUTIONS I THINK THAT ARE CALLING FOR OPENNESS AND TRANSPARENCY IN PROVIDING THIS KIND OF DATA, SO I THINK THAT'S A STEP IN THE RIGHT DIRECTION IN TERMS OF HELPING US AND THE NIH IN GENERAL MOVE FORWARD WITH HOW TO SUPPORT THE NEXT GENERATION, JUST IN TERMS OF GETTING THE DATA THAT WE NEED TO EVEN DEFINE WHAT IT IS THAT WE'RE TRYING TO DO. >> HI, I WAS JUST GOING TO MAKE A COMMENT TO JOSE AS SOMEONE WHO IS FOLLOWING THE CONVERSATION ON TWITTER AS WELL, THERE SEEMS TO BE SOME CONFUSIN BY THOSE WATCHING ONLINE AS TO THE AT RISK DEFINITION AND WHETHER THAT'S WITHIN THE ESI, EEI DEFINITION, OR WHETHER THAT'S GOING TO BE ACROSS CAREER STAGE, SO I THOUGHT MAYBE YOU WOULD WANT TO CLARIFY THAT FOR SOME PEOPLE WHO ARE STILL A LITTLE BIT CONFUSED. >> SO THERE IS A DEFINITION OF E SI THAT REMAINS THE SAME EXCEPT THAT IT IS NOW INCREASED FROM 10 TO 15 YEARS AND IT ALSO CLURS A PROVISION BY WHICH SOMEBODY CAN CLAIM TO BE AN ESI AT THE TIME THEY RECEIVE THEIR FIRST INDEPENDENT FACULTY APPOINTMENT IN SIX TO SEVEN YEARS SO ESI DEFINITION IS EXPANDED. AT RISK IS AT RISK ACROSS THE WORKFORCE BUT I WANT TO MAKE IT CLEAR THAT IT IS MEASURE MERITORIOUS INVESTIGATORS, PEOPLE WHO PROPOSE GOOD SCIENCE, PEOPLE SCORING IN THE TOP 75TH PERCENTILE WHEN IT COMES TO THEIR FUNDING SO AT RISK IS AT RISK OF LUFERSING ALL NIH FUNDING WITHIN -- OF LUFERSING ALL NIH FUNDING WITHIN THE YEAR. >> JUST A FRIENDLY AMENDMENT, THESE ARE DRAFT RECOMMENDATION, NOT THE FINAL RECOMMENDATIONS THAT WILL BE PRESENTED TO THE AC D AS A WHOLE WITH THEIR CONSIDERATION FOR THEIR CONSIDERATION AND THEY WILL MAKE THEIR TROAMTION THE NIH DIRECTOR MAKE THEIR RECOMMENDATION TO THE NIH. >> AND THEN THE NIH DIRECTOR CAN SAY THAT WAS A NICE IDEA BUT I'M NOT GOING TO CONTINUE TO -- [LAUGHTER] >> YEAH, DIE THAT ALL THE TIME. IT WILL BE HARD THIS TIME THOUGH , BECAUSE YOU GUYS -- YEAH , I DO THAT ALL THE TIME. IT WILL BE HARD BECAUSE YOU GUYS HAVE BEEN WORKING REALLY HARD AND THIS IS A THOUGHTFUL SET OF WE'LL LOOK FORWARD TO HEARING THE FINALS IN SIX MONTHS. BY THE TIME WE GET TO THAT, WE MAY BE ABLE TO TELL YOU SOME RESULTS OF EXPERIMENTS THAT WILL INFORM THIS AS WELL. TERRIFIC. WE ARE RIGHT ON SCHEDULE. LET'S MOVE TO THE UPDATE WORKING GROUP, MIKE LAUER, THE TOPIC OF RIGOR AND REPRODUCIBILITY. >> GREAT. THANK YOU VERY MUCH, FRAN CIRCUMSTANCES IT'S NOW 2 BM, WE ARE NOW THOROUGHLY POST PYRAND I ALR IT HYPOGLYCEMIA ACROSS THE ROOM, NOW WE'LL TALK ABOUT RIG GARR. THIS IS AN UPDATE FROM DECEMBER. THIS ALSO STEMS IN PART FROM THE 21ST CENTURY CURES ACTED, THERE'S A SECTION IN THERE THAT RIERPZ THE NIH DIRECTOR TO CONVENE A WORKING GROUP UNDER THE ACD TO DEVELOP AND ISSUE RECOMMENDATIONS WHICH MAY INCORPORATE OR BE INFORMED BY RELEVANT EXISTING AND ONGOING ACTIVITIES TO ENHANCE RIGOR IS REPRODUCIBILITY OF THE SCIENTIFIC RESEARCH THAT'S FUND ED BY NIH AND THIS AS YOU KNOW IS A TOPIC THAT'S BEEN UNDER CONSIDERATION AND UNDER EXTENSIVE DISCUSSION FOR QUITE A LONG TIME. HERE ARE THE MEMBERS OF THE WORKING GROUP, RUSS ALTMAN CHAIRED T LISA COOP HER, JOSE, R FLORES, FRS PETER McLEESH, WE HAD IMPLEMENTATION FROM THE EXTRAMURAL RESEARCH AND AWLTSES THE OFFICE OF SCIENCE POLICY. I WANT TO GIVE A PARTICULAR SHOUT OUT TO DR. PATRICIA VALDEZ WHO IS HERE WHO HAPPENS PUT IN A TREMENDOUS AMOUNT OF WORK IN THIS AREA FOR A NUMBER OF YEARS, AND THEN THERE ARE AIM NUMBER OF OTHER COLLEAGUES AT NIH WHO HELPED WITH THIS AS WELL. A REMINDER OF THE TIMELINE, THIS IS DECEMBER OF 2016 WHTD 21ST CENTURY CURES ACT WAS PASSED, WE CONVENED A WORKING GROUP IN THE SPRING OF 2017 ABOUT A YEAR AGO, WE PRESENTED OUR VERY FIRST PRELIMINARY REPORT IN JUNE OF 2017, EXACTLY A YEAR AGO. THEN HAD A MORE EXTENSIVE DISCUSSION ABOUT POTENTIAL OPTIONS. AND I'LL REMIND YOU A LITTLE BUILT OF WHAT THEY WERE IN JUST A BIT. IN DECEMBER, ABOUT SIX MONTHS AGO, WE PRESENTED A NUMBER OF OPTIONS HERE TO YOU AND WE DID HEAR YOUR FEEDBACK, WHICH I'LL TALK ABOUT IN A MOMENT, THEN WE TOOK THAT FEEDBACK AND TRIED TO COALESCE IT INTO SOME KIND OF SET OF CONCRETE RECOMMENDATIONS. NOW THEN WHAT WE DID WAS WE PRESENTED THESE CONCRETE RECOMMENDATIONS OR POTENTIAL CONCRETE RECOMMENDATIONS TO A NUMBER OF TRANS-NIH COMMITTEES. WE HAVE A NUMBER OF COMMITTEES THAT SPAN THE VARIOUS IC'S THAT COVER AREAS LIKE TRAINING AND GRANTS MANAGEMENT, PROGRAM AND PEER REVIEW, AND THEN THEY ALL LEAD TO A GROUP WHICH WE CALL THE EXTRAMURAL WORK GROUP WHICH JOHN LORCH AND I CO-CHAIR, THAT REPORTS TO THE STEERING COMMITTEE TO THE NIH DIRECTOR, SO THESE FUNCTIONAL COMEEZ REVIEWED THESE -- CAN COMMITTEES REVIEWED THESE AND NOW WE'LL SHOW YOU WHERE WE ARE. AS A REMINDER, IN JANUARY OF 2016 AFTER AN EXTENSIVE HAD DELIBERATION SHES THERE WERE CHANGES MADE IN EXPECTATIONS OF APPLICATIONS FOR RPG'S AND WE SPECIFICALLY FOCUSED ON FOUR AREAS, SCIENTIFIC PREMISE, SCIENTIFIC RIGOR, CONSIDERATION OF BIOLOGICAL VARIABLES, RELEVANT BIOLOGICAL VARIABLES INCLUDING SEX AS A BIOLOGICAL VARIABLE AND AUTHENTICATION OF KEY BIOLOGICAL AND CHEMICAL RESOURCES. SO THESE THREE COMPONENTS, PREMISE, RIGOR AND RELEVANT BIOLOGICAL VARIABLES WERE TO BE INCORPORATED INTO THE RESEARCH PLAN AND THEY WERE TO BE ALSO INCORPORATED INTO PEER REVIEW. THE AWE THEN INDICATION ISSUE WAS TO COME IN A SEPARATE ATTACHMENT AND WHILE IT WOULD NOT CONTRIBUTE TO THE SCORE, THE PEER REVIEW WOULD MAKE A JUDGMENT AS TO WHETHER OR NOT AUTHENTICATION WAS ADEQUATE OR INADEQUATE. SO THIS WAS IMPLEMENTED BACK IN JANUARY OF 2016, SO WE'VE BEEN DOING THIS NOW FOR A COUPLE OF YEARS. SO LAST DECEMBER WHEN WE CAME TO YOU, WE DISCUSSED A NUMBER OF IDEAS OF NEW FORMS THAT COULD BE ADDED THAT WOULD ADDRESS THESE ISSUES OF PREMISE, RIGOR AND INCLUSION OF APPROPRIATE BIOLOGICAL VARIABLES, WE ALSO TALKED ABOUT A CHECKLIST, YOU MAY REMEMBER WE SHOWED YOU SOME EXAMPLES OF CHECKLISTS THAT WE COULD USE, SOME OF THESE CHECKLISTS ARE MODELED BY WHAT SOME OF THE BIOMEDICAL JOURNALS ARE DOING, AND WE HEARD VERY LOUDLY AND CLEARLY FROM YOU THAT THERE IS POSITIVE DESIRE FOR ANY NEW FORMS AND THERE WAS NO DESIRE FOR CHECKLISTS, AND BY THE WAY WHEN WE DISCUSED THIS WITH OUR COLLEAGUES ACROSS NIH, THE VARIOUS TRANS-NIH COMMITTEES , WE HEARD THE EXACT SAME MESSAGE. BUT NONETHELESS WHAT IS TRUE IS THAT MANY PEOPLE FROM MANY DIFFERENT GROUPS AT NIH OUTSIDE OF NIH HAVE PUT A TREMENDOUS AMOUNT OF THOUGHT INTO ENHANCING THE RIGOR OF BIOMEDICAL RESEARCH AND SOME OF THAT THOUGHT HAS LED TO CONCRETE PRODUCTS OR CONCRETE RESOURCES THAT ARE REALLY QUITE GOOD AND THAT PEOPLE CAN USE, SO ONE OF THE RECOMMENDATIONS WAS TO -- FOR NIH TO MAKE IT CLEAR THAT THESE RESOURCES ARE AVAILABLE, THAT WE WELCOME PEOPLE TO USE THEM AND THAT THAT BETTER PROPOSALS. I'LL SHOW YOU THAT IN A BIT. THAT'S THE FIRST RECOMMENDATION. THE SECOND WAS CLARIFY WHAT'S MEANT BY SCIENTIFIC PREMISE AND I WANT TO PARTICULARLY COMMEND SHY SILVER BERING FROM NINDS, SPENT A LOT OF WORK ON WHETHER OR NOT PEOPLE WERE UNDERSTANDING WHAT EXACTLY SCIENTIFIC PREMISE S WHAT EXACTLY IS IT WE WERE AFTER, IS SCIENTIFIC PREMISE THE SAME THING APPEARS THE HYPOTHESIS OR SOMETHING ELSE, AND SO WE HAVE SOME RECOMMENDATIONS ABOUT CLARIFYING WHAT EXACTLY IT IS THAT WE'RE AFTER. THE THIRD IS SOME PEOPLE WERE CONCERNED THAT THEY DIDN'T EXACTLY KNOW WHAT EXACTLY WE WANTED IN TERMS AUTHENTICATION PLANS SO THEY SUGGESTED THAT NOW THAT WE HAVE DEVELOPED SOME EXPERIENCE IN LOOKING AT AUTHENTICATION PLANS, WE COULD FIND THINGS WE THINK ARE PARTICULARLY GOOD AND ASK THE INVESTIGATORS IF THEY WOULD BE WILLING TO VOLUNTEER THEIR AUTHENTICATION PLANS AS EXAMPLES OF WHAT WE CONSIDER TO BE PARTICULARLY USEFUL. THE FOURTH RECOMMENDATION WAS TO INTEGRATION RIGOR INTO TRAINING AND THAT THE SPECTRUM OF RIGOR AND RESPONSIBILITY WITHIN RESEARCH SHOULD BE ONE WELL CO- HEE SI LZ ROLE WITHIN TRAINING AND THEN THE FIFTH RECOMMENDATION IS TO ENGAGE IN CONTINUOUS EVALUATION AS TO WHETHER OR NOT DR. THESE EFFORTS ARE ACTUALLY LEADING TO IMPROVED OUTCOME. LET ME STARTED WITH RESOURCES. IT'S BEEN RECOMMENDED WE MAKE RESOURCES AVAILABLE PERHAPS WE COULD SAY WE COULD MARKET THEM WITHOUT REQUIRING THEM AND WE COULD THINK OF RESOURCES AS THOSE THAT ARE INTERNAL, MEANING THEY CAME FROM NIH OR CAME FROM NIH-FUNDED PROJECTS, OR EXTERNAL , THEY ARE COMING FROM OTHER BODIES, AND THIS IS NOT A SACRED LIST. THIS IS NOT A RESTRICTIVE LIST. AS MORE NEW RESOURCES THAT ARE PARTICULARLY GOOD BECOME AVAILABLE, WE WOULD LIKE THE COMMUNITY TO KNOW ABOUT THEM. SO THESE ARE EXAMPLES. THE OFFICE OF BEHAVIORAL AND SOCIAL SCIENCE RESEARCH HAS A WHOLE VARIETY OF TRAINING RESOURCES TO HELP PEOPLE PUT TOGETHER STRONGER PROPOSALS AND BEHAVIORAL AND SOCIAL SCIENCE RESEARCH. NIGMS, AS PART OF THIS RIGOR EFFORT HAS FUNDED A NUMBER OF PROJECTS TO HELP SO THAT PEOPLE COULD PUT TOGETHER TRAINING MODULES, AND I DON'T KNOW HOW MANY OF YOU HAVE LOOK AT THESE. SOME OF THEM ARE REALLY QUITE GOOD, SOME OF THEM ARE VIDEOS WITH REALLY GREAT STORYLINES, AND THESE ARE POTENTIALLY QUITE USEFUL FOR PEOPLE, SO WE WOULD LIKE PEOPLE TO USE THEM. THE OFFICE OF DISEASE PREVENTION , AND HERE I WANT TO PARTICULARLY COMMEND DAVID MURRAY, THEY HAVE PUT TOGETHER RESOURCES ON HOW YOU RUN, FOR EXAMPLE, A CLUSTER RANDOMIZED TRIAL OR A GROUP RANDOMIZED TRIAL, HOW YOU CALCULATE SAMPLE SIZES, A NUMBER OF RECOGNIZED REFERENCES THAT CAN HELP PEOPLE PUT TOGETHER HIGH QUALITY PROPOSALS SMGHTS. HERE ARE SOME EXAMPLES OF EXTERNAL RESOURCES THAT SOME OF US WERE AWARE OF AND OTHERS OF US BECAME AWARE OF IN THIS EFFORT. SOME OF YOU MAY HAVE CALLED OF THE SO-CALLED SPIRIT INITIATIVE, WHICH IS THE SAME GROUP HE THAT IS PART OF EE QUAIL TORE ACCIDENT IT'S THE GROUP THAT PUT TOGETHER THE CONCERT GUIDELINES THAT WE TALKED ABOUT LAST DECEMBER, THESE ARE THE CONCERT GUIDELINES FOR RANDOMIZED TRIALS SO THIS SAME GROUP OF PEOPLE HAVE PUT TOGETHER RECOMMENDATION S FOR WHAT TYPES OF ELEMENTS SHOULD BE PRESENTED IN LET'S SAY AN EXPERIMENT THAT INVOLVES HUMANS, WHAT ARE THE TYPES OF ELEMENTS THAT SHOULD BE CONSIDERED AND IN A WAY THIS COULD HELP AN INVESTIGATOR PUTTING TOGETHER A PROPOSED PROJECT TO SADIE THINK OF THIS, DID I THINK OF THIS AND THIS AND IN THIS WAY NOT FORGET ANYTHING. THE MEDICAL RESEARCH COUNCIL IN THE UK STRONGLY ENCOURAGES THEIR INVESTIGATORS TO USE THIS SO-CALLED EDA EXPERIMENTAL DESIGN ASSISTANT, I'M CURIOUS, HAVE ANY OF YOU SEEN THIS? SO THIS IS QUITE INTERESTING. SO THIS IS PARTICULARLY DESIGNED FOR PRECLINICAL ANIMAL MODEL WORK, AND IT HAS THESE TOOLS BY WHICH YOU CAN DESIGN AN EXPERIMENT, AND SOME OF THE TOOLS ARE VISUAL, AND SOME OF THEM YOU CAN PUT TOGETHER ALGORITHMS, AND THE MRC LIKES THIS SO MUCH THAT THEY ARE VERY STRONGLY ENCOURAGING THEIR APPLICANTS TO USE IT. SO THERE'S NO REQUIREMENT HERE TO USE IT, BUT WHAT WE WANT TO DO IS WE WOULD LIKE TO MAKE PEOPLE AWARE THAT THIS EXISTS. SOME VERY THOUGHTFUL PEOPLE PUT THIS TOGETHER AND THIS MAY BE SOMETHING THAT OUR APPLICANTS MAY FIND USEFUL AS THEY ARE PUTTING TOGETHER THEIR PROPOSALS OKAY. SO THAT IS RESOURCES. THE SECOND RECOMMENDATION HAD TO DO WITH CLARIFYING WHAT IS MEANT BY SCIENTIFIC PREMISE, AND YOU MAY REMEMBER THAT THERE'S CONFUSION ABOUT WHAT EXACTLY DIST WORD PREMISE MEAN DISRKS IT MEAN HYPOTHESIS. THESE ARE THE CURRENT APPLICATION INSTRUCTIONS FOR SCIENTIFIC PREMISE, IT SAYS DESCRIBE THE SCIENTIFIC PREMTION FOR HAD THE PROPOSED PROJECT INCLUDING CONSIDERATION OF THE STRENGTHS AND WEAKNESSES OF PUBLISHED RESEARCH OR PRELIMINARY DATA CRUCIAL TO THE SUPPORT OF YOUR APPLICATION. IN ORDER TO MAKE IT MORE CLEAR WHAT EXACTLY IT IS THAT WE'RE TALKING ABOUT, THE PROPOSED REVISION WOULD SAY RIGOR OF PRIOR RESEARCH, THAT'S REALLY WHAT WE'RE INTERESTED IN AND WE ASK AM CANTSZ TO DESCRIBE THE STRENGTHS AND WEAKNESSES IN THE RIGOR OF PRIOR RESEARCH BOTH PUBLISHED AND UNPUBLISHED BEING CITED AS KEY SUPPORT FOR YOUR RESEARCH QUESTIONS SO WE'RE MAKE IT GO VERY CLEAR THAT WHAT IT IS THAT WE'RE REALLY INTERESTED IN IS THE APPLICANTS' THOUGHTS ABOUT THE STRENGTHS AND WEAKNESS ES OF THE RIGOR OF PRIOR RESEARCH, AND THEN HOW DOES THEIR PROPOSAL ADDRESS THOSE STRENGTHS AND WEAKNESSES, HOW DOES THEIR PROPOSAL LEVERAGE THE STRENGTHS AND/OR DEAL WITH, ADDRESS SOME OF THE WEAKNESSES. THEN IN THE REVIEW CRITERIA FOR OUR PREMISE, RIGHT NOW THE REVIEW CRITERIA QUESTION IS SIMPLY THIS, IS THERE A STRONG SCIENTIFIC PREMISE FOR THE PROJECT, AND INSTEAD, WE WOULD CHANGE THAT TO SAY DOES THE APPLICATION DESCRIBE THE STRENGTHS AND WEAKNESSES IN THE RIGOR OF PRIOR RESEARCH BEING CITED AS KEY SUPPORTED FOR THE PROPOSED QUESTIONS, HAS THE APPLICANT INCLUDED A PLAN TO ADDRESS SUCH RIGOR ISSUES THAT POTENTIALLY WEAK WEAKEN THE PROPOSAL. ONE AREA OF ACTIVE DEBATE, AND THIS IS SOMETHING WE WOULD VERY MUCH HOPE WE COULD ASK YOU TO ADDRESS IN THE DISCUSSION IS WHERE EXACTLY THIS DISCUSSION ABOUT THE RIGOR OF PRIOR RESEARCH, THE STRENGTHS AND WEAKNESSES OF PRIOR RESEARCH SHOULD BE. SHOULD IT BE IN THE SECTION OF THE APPLICATION THAT ADDRESSES SIGNIFICANCE, OR SHOULD IT BE IN THE SECTION OF THE APPLICATION THAT ADDRESSES APPROACH? SO RIGHT NOW IT'S IN THE SIGNIFICANT SECTION WHERE THE INSTRUCTIONS SAY EXPLAIN THE IMPORTANCE OF THE PROBLEM OR CRITICAL BARRIER TO GAIN NEW KNOWLEDGE IN THIS AREA, HOW WILL THE PROPOSED PROJECT IMPROVE KNOWLEDGE CAPABILITY IN THEIR CLINICAL PRACTICE, THEN WE WOULD PUT THIS NEW REVISED INSTRUCTION DESCRIBING THE STRENGTHS AND WEAKNESSES AND THE RIGOR OF PRIOR RESEARCH IN THE SIGNIFICANT SECTION, AND THAT'S WHERE IT IS RIGHT NOW. SOME FOLKS THINK THAT IT WOULD MAKE MORE SENSE TO PUT THIS DISCUSSION ABOUT THE STRENGTHS AND WEAKNESSES OF PRIOR RESEARCH IN THE APPROACH SECTION, SO I HEARD VERY COMPELLING ARGUMENTS BOTH WAYS, AND IT WOULD BE INTERESTING TO HEAR YOUR THOUGHTS ABOUT THAT. OKAY. THE THIRD RECOMMENDATION IS WE THINK FAIRLY STRAIGHTFORWARD AND WHAT WE WOULD DO IS ASK OUR STAFF COULD YOU IDENTIFY SOME AUTHENTICATION PLANS THAT YOU THINK ARE REALLY QUITE STRONG AND THEN WE WOULD TAKE A LOOK AT THOSE, ASSEMBLE A BODY OF AUTHENTICATION PLANS ACROSS A WIDE RANGE OF SCIENCE AND THEN ASK THE INVESTIGATORS WHETHER OR NOT THEY WOULD BE WILLING TO ALLOW US TO POST THEM AND THEN WE COULD POST THESE ONLINE AND PEOPLE COULD LOOK AT THEM AND HOPEFULLY THAT WILL HELP THEM PUT THEIR AUTHENTICATION PLANS TOGETHER. WE TALKED ABOUT TRAINING FAIRLY EXTENSIVELY DURING THE LAST MEETING IN LAST DECEMBER, AND THE IDEA HERE IS TO INTEGRATE TRAINING IN RIGOR THROUGHOUT TRAINING APPLICATIONS. WE'RE VERY FORTUNATE IN THAT IMT MS HAS PUT OUT AID NEWLY 32 F OA FOR PREDOCTORAL TRAINING, THIS WAS JUST PUT OUT LATE LAST YEAR AND THE FIRST DUE DATE WAS JUST A FEW WEEKS AGO, MAY 25RBGS 2018, AND WE TALKED WITH ABOUT THIS LAST DECEMBER, IF YOU READ THIS FOA THE IDEA OF INTEGRATING RIGOR INTO THE TRAINING, INTO THE FACULTY, INTO THE CULTURE AND INTEGRATING RIGOR AND RESPONSIBLE CONDUCT OF RESEARCH, THIS IS ALL THROUGHOUT THE FOA, JOHN CAN TALK ABOUT THIS A BIT MORE. THIS INCORPORATION OF RIGOR INTO THE WHOLE FABRIC OF THE PROGRAM CONTRIBUTES TO THE REVIEW SCORE, OUR HOPE IS THAT WE'LL SEE HOW THIS GOES AND THIS WILL EVENTUAL LY INFORM THIS AN NIH- WIDE APPROACH. THEN FINALLY OUTCOMES EVALUATIONS. NOW, THIS TURNS OUT TO BE REALLY HARD TO DO. WE ACTUALLY CONTRACTED WITH AN OUTSIDE FIRM, A VERY REPRESENT UTT OOBLGHT R AGENT OWSES DAIRK H VERY REPUTABLE OUTSIDE FIRM TO LOOK AT WHETHER OR NOT THERE HAVE BEEN CHANGES IN APPLICATIONS SINCE WE IMPLEMENT ED THE NEW RIGOR POLICY AND IT WAS DIFFICULT TO DO THIS, DIFFICULT TO GET OUR JUDGES, SO TO SPEAK, TO UNDERSTAND THAT WE WEREN'T ASKING THEM TO REVIEW THE SCIENCE, WE WERE ASKING THEM TOLL REVIEW WHETHER OR NOT CERTAIN ISSUES WERE BEING DREALSD, WERE THE APPLICANTS DREARING QUESTIONS OF RIGOR ACCIDENT QUESTIONS OF BIOLOGICAL VARIABLES, SO THIS HAS BEEN GOING BACK AND FORTH, THERE ARE A NUMBER OF THE IC'S THAT HAVE CONDUCTED SOME EVALUATIONS AND IN PARTICULAR NINDS AND SHI MAY WANT TO ADDRESS THAT BUT THIS IS AN AREA WHERE THERE'S CONTINUING ONGOING EVALUATION. ANOTHER POINT POINT S WE'VE MADE THIS POINT IN OUR PREVIOUS PRESENTATIONS, THIS IS NOT AN ISOLATED EFFORT, THERE ARE MULTIPLE STAKEHOLDERS WHO ARE INVOLVED WITH THIS, OF COURSE WE'RE VERY PLEASED TO SEE THAT, SO ONE AREA OF DISCUSSION, WE DON'T HAVE AN ABSOLUTELILY FIRM PLAN, BUT ONE AREA OF DISCUSSION IS WORKING TOGETHER WITH JOURNAL S, FOR EXAMPLE, WE WOULD LIKE TO SEE WHETHER OR NOT IT IS ACIALS THAT ARE APPEARING THAT ARE FUNDED BY NIH RESEARCH, NIH FUNDING ARE THESE ARTICLES REFLECTIVE OF MORE RIGOROUS SCIENCE THAN PERHAPS WE HAD SEEN IN THE PAST SCO THAT'S ANOTHER AREA WE ARE ADDRESSING. RECOMMENDATIONS. THE MOST IMPORTANT PERHPAS IS THAT THERE WILL BE NO NEW FORMS AND NO CHECKLISTS, BUT WE WANT TO MAKE RESOURCES AVAILABLE AND PERHAPS A BIT OF SOFT MARKETING OF THESE RESOURCES AS REALLY MORE HIGH QUALITY RESOURCES BECOME AVAILABLE WE WOULD MAKE THE COMMUNITY AWARE OF THEM. THE SECOND IS SOME CLARIFICATION ABOUT WHAT IS MEANT BY SCIENTIFIC PREMISE, AND WE HAVE A QUESTION ABOUT WHETHER OR NOT DESCRIPTIONS OF THE RIGOR OR PRIOR RESEARCH IS MORE APROPOS FOR THE SIGNIFICANT SECTION OR FOR THE APPROACH SECTION. THE THIRD IS THAT WE MAKE AVAILABLE ONLINE EXAMPLES OF STRONG AUTHENTICATION PLANS. THE FOURTH IS THAT WE'LL FOLLOW WHAT HAPPENS WITH THE NIGMS T32 PROGRAM AS POTENTIAL AN EXEMPLAR OF INCORPORATING RIGOR INTO THE FABRIC OF TRAINING AND THE FIFTH IS EVALUATIONS. SO WE HOPE YOU FIND THIS INTERESTING AND I WOULD BE HAPPY TO TAKE ANY COMMENTS OR QUESTIONS. >> MIKE, THANKS VERY MUCH FOR WALKING US THROUGH THIS. IF I WAS RIGHT NOW WRITING A GRANT TO NIH AND IT WAS ABOUT AN ANIMAL MODEL OF DISEASE AND I WAS GOING TO PROPOSE AN INTERVENTION TO SEE WHETHER IT WOULD IMPROVE THE PHENOTYPE AND OBVIOUSLY THERE IS ONE OF THOSE AREAS WHERE WE KNOW FROM THE PAST THERE'S BEEN A LOT OF DIFFICULTY WITH REPRODUCIBILITY DLRKS WEDNESDAY AFTERNOON LECTURE YESTERDAY WE SPENT THE FIRST HALF HOUR PRACTICALLY GOING OVER ALL THE STUDIES OF A NONREPRODUCIBLE MEASUREMENT OF ANXIETY IN MICE, WHICH SEEMED TO BE PRIMARILY BECAUSE OF POOR STUDY DESIGN AND FAILURE TO REPORT ALL THE TEE TAILS, SO I KNOW THIS IS ONE OF THE THINGS WE'RE REALLY TRYING TO TACKLE HERE. WHAT WOULD I EXPECT TO HAVE TO DEFEND IN THAT APPLICATION IN TERMS OF AWFL THE PRINCIPAL PELTZ THAT WE WOULD TAKE FOR GRANTED IN A HUMAN CLINICAL TRIAL BUT ARE OFTEN NEGLECTED IN A ANIMAL TRIAL, SUCH AS POWER CALCULATION, SUCH AS BLINDING OF INVESTIGATORS, RANDOMIZATION AND SO ON? WOULD I GET DINGED BY THE WALE WE ARE NOW PUTTING THIS WHOLE SET OF REVIEW CRITERIA IN PLACE IF I DIDN'T DO THAT OR COULD I STILL SNEAK THROUGH? >> I THINK THE PAPER THAT DRRMSZ STOREY AND SHI PUT OUT IN NATURE IN 2012 ADDRESSED THOSE, THE EXPLICIT ABOUT WHAT'S EXPECTED. YES, THERE SHOULD BE A DESCRIPTION OF RANDOMIZATION, AND OF BLINDING, AND OF DATA MANAGEMENT, AND A DESCRIPTION OF POWER AND SAMPLE SIZE, THERE SHOULD BE A DESCRIPTION, A DETAILED DESCRIPTION OF INTERVENTION AND OUTCOME. WE KNOW THERE'S BEEN SOME INTERESTING WORK THAT'S BEEN PUBLISHED IN DIFFERENT FIELDS SHOWING THAT FOR EXAMPLE FOR RANDOMIZATION YOU ONLY SEE ANY MENTION OF RANDOMIZATION DESCRIBED FOR OUR RODENT MODELS IN MAYBE 30% OF PAPERS. FOR SAMPLE SIZE CALCULATIONS IT'S LESS THAN 1%, IT'S SOMETHING WHICH IS SIMPLY SOMETHING NOT DISCUSSED. SO WHEN WE TALKED ABOUT THE IDEA OF CHECKLISTS, THE IDEA WAS THAT WE WOULD SAY, YOU KNOW, DID YOU ADDRESS SAMPLE SIZE? YES, NO OR NOT APPLICABLE. HERE NOW THIS EXPERIMENTAL DESIGN ASSISTANT FORCES YOU TO THINK THROUGH ALL THESE THINGS. NOW, YOU COULD PRETEND THAT THEY DON'T EXIST, BUT IT DOES SAY, IT FORCES YOU TO THINK ABOUT THOSE. >> BUT I GUESS I'M ASKING IN TERMS OF HOW THIS WOULD BE REVIEWED RIGHT NOW, THESE ARE GOOD PRINCIPLES THAT WE'VE ADVOCATED FOR BUT THEY'RE NOT NECESSARILY BEING RIGOROUSLY ENFORCED ZOON THE RIGHT NOW, NO. NO. >> NOT RIGHT NOW, NO. NO. ONE THING WE HAVE TALKED ABOUT, I'LL GIVE IT AS MAYBE AN EXAMPLE FROM A DIFFERENT FIELD, BUT IN THE PICORI, PATIENT CENTER FOR OUTCOME ARE RESEARCH INSTITUTED, CERTAIN STUDIES F THEY GET THROUGH THE FIRST ROUND OF PEER REVIEW AND GET A RIENLLY GOOD SCORE, THEY NEXT GO THROUGH A REALLY RIGOROUS METHODOLOGICAL REVIEW BY PEOPLE WHO THIS IS WHAT THEY THINK ABOUT AND IF IT DOESN'T PASS THAT, THEN IT DOESN'T GO TO FUNDING. THIS IS SOMETHING THAT A NUMBER OF JOURNALS DO, IF ON INITIAL PEER REVIEW THERE IS ENTHUSIASM FOR THE PAPER, NEXT IT GOES TO A STATISTICAL REVIEWER, ANALYTICAL REVIEWER, SOME OF THE JOURNALS ARE EXTREMELY, NO PUN INTENDED, RIGOROUS ABOUT THIS, AND THE IDEA IS THAT THAT WAY THEY'RE MORE LIKELY TO PUBLISH HIGHER QUALITY WORK. >> BRENDAN, THEN LINDA. >> I THINK FRANCIS YOU MENTIONED THE QUESTION THAT YOU POSED EXACTLY, WHICH IS I THINK RIGOR AND YOUR DEFINITION OF SCIENTIFIC PREMISE FITS IN BOTH SIGNIFICANCE AND IN APPROACH BECAUSE YOU ANSWERED IT METHODOLOGICALLY. YOU CAN DESIGN A PERFECT HUMAN CLINICAL TRIAL AND IF THE ENDPOINTS ARE INAPPROPRIATE FOR THE CLINICAL DISEASE, THEN THERE'S REALLY NO SIGNIFICANCE OF THAT, EVEN THOATS A PERFECTLY DESIGNED CLINICAL TRIAL. SO I THINK THE ANSWER IS YOU NEED IT IN BOTH AND IT HAS TO BE ADDRESSED IN BOTH BECAUSE YOU COULD HAVE A PERFECT EXPERIMENT, PERFECTLY DESIGNED THAT DOESN'T IMPACT ANYTHING. SO THAT'S THE ANSWER FROM MY PERSPECTIVE. I THINK THE OTHER ISSUE I WOULD SHARE WITH YOU, I THINK THAT ONE OF THE CHALLENGES WE HAVE AS A FIELD, OF COURSE, IS THAT SO MANUFACTURE OUR MODELS ARE NOT RIGOROUS, NOT SO MUCH FROM A METHODOLOGICAL PERSPECTIVE AS FROM A DISEASE TRANSLATIONAL PERSPECTIVE. I DON'T KNOW WHAT THE ANSWER IS. THAT'S A REVOLUTIONARY TYPE OF PROBLEM. >> LINDA? >> TWO POINTS. FIRST IS THIS IS INCREDIBLY DOMAIN SPECIFIC, WHICH IS WHY WE ADVOCATE PUTTING UP EXAMPLES FOR SPECIFIC DOMAINS. SO THE MICE, FOR EXAMPLE, INVESTIGATOR MOVES FROM INSTITUTION A TO INSTITUTION B AND NOW THE DISEASE MODEL DOESN'T WORK ANYMORE, AND I KNOW A LOT OF PEOPLE THAT HAPPENED TO , AND IT'S THE MICROBIOME AND WHAT THEY'RE EATING. SO DO WE DEMAND, YOU KNOW, AS MORE INFORMATION COMES OUT AS TO KNOWN VARIABLES THAT AFFECT THINGS LIKE THAT, HOW DO WE GET THOSE INTO THE ZEITGEIST OF PEOPLE, EXAMPLES ON THE WEBSITE OF GRANTS IN A PARTICULAR AREA CAN BE INCREDIBLY USEFUL JUST IN RAISING AWARENESS IN THE COMMUNITY OF THINGS THAT MAY NOT HAVE COMPLETELY DISSEMINATED. SO THAT COMES UP IN MY LIFE, ANTIBODIES, ALL KIND OF REAGENT TION, EVERYBODY COMPLAINS ABOUT THIS, AND THERE'S DIFFERENT WAYS DIFFERENT COMMUNITIES DEAL WITH THIS. THERE'S SMALL COMMUNITIES THAT GET TOGETHER AND VALIDATE ANTIBODIES AS A COMMUNITY IN THEIR PARTICULAR TARGETS, THERE'S NONPROFIT TRYING TO DO THIS, BUT EXAMPLES OF THESE THINGS ON THE NIH WEBSITE CAN BE INCREDIBLY GOOD AT RAISING THE BAR FOR WHAT IS EXPECTED OF YOU AND THAT ALSO GUIDES REVIEWERS IF YOU CAN GET THE REALLY GOOD EXAMPLE. >> MAYBE WE CAN IMPOSE ON SHI. DO YOU HAVE COMMENTS ABOUT THIS, SHI? I KNOW YOU'VE THOUGHT ABOUT THIS SO DEEPLY. >> WOULD YOU COME TO A MICROPHONE? >> AND REALLY, YOU KNOW, YOU REALITY PLAYED A LEADING -- YOU REALLY PLAYED A LEADING ROLE IN THIS. >> THANKS FOR THE OPPORTUNITY TO SAY A FEW WORDS ABOUT THIS. DR. LEE, YOU RAISE A VERY IMPORTANT POINT AND THAT'S THE WHOLE IDEA OF HAVING TWO KINDS OF RIGOR THAT WE'RE LOOKING AT. THE RIGOR OF THE SUPPORTING DATA AND THE RIGOR OF THE PROPOSED EXPERIMENTS. SO OBVIOUSLY THE RIGOR OF PROPOSED SPERMINGTS NEEDS TO BE -- EXPERIMENTS NEEDS TO BE IN THE APPROACH BECAUSE THAT'S WHAT YOU PLAN TO DO. MY PERSONAL FEELING IS, AND I KNOW THERE ARE OTHER OPINIONS ON THIS, THAT THE RIGOR OF THE SUPPORTING DATA, WHICH IS THE FOUNDATION, SHOULD BE IN THE SIGNIFICANCE. AS FAR AS DR. COLLINS' QUESTION ABOUT WHAT HAPPENS RIGHT NOW, REVIEWERS ARE THE SAME SCIENTISTS WHO ARE DOING THE RESEARCH. THEY ARE THE PEESHZ. -- THEY ARE THE PEERS. THAT'S WHY IT'S IMPORTANT WHAT WE'VE HEARD HERE THAT TRAINING IS SO IMPORTANT BECAUSE IF YOU JUST LOOK AT THE PAPERS OUT THERE, EVEN NOW, THERE ARE SO MANY ISSUES TRARK IN HOW THINGS ARE DONE RG AT LEAST HOW WILL THEY REPORT IT, AND THERE'S INDIRECT EVIDENCE THAT IF IT'S NOT REPORTED, IT ALSO WASN'T ACTUALLY DONE IN MANY CASES. , SO THIS HAS TO BE LONG-TERM. THAT'S ONE OF THE REASONS WHY, IT'S A BAD CHOICE OF WORDS, SCIENTIFIC PREMISE, BUT TENSION ON THE RIGOR OF THE SUPPORTING DATA WOULD HAVE A HUGE IMPACT ON THE FUTURE BECAUSE PEOPLE WILL START THINKING, WELL, I BETTER DO THE THINGS CAREFULLY AND REPORT THEM CAREFULLY BECAUSE DISH. >> SHOW NUP A FUTURE APPLICATION >> YES, IN A FUTURE APPLICATION, YOU KNOW, AND THEN IT WILL BE DINGED. SO THAT'S KIND OF MY TWO CENTS. >> JUST TO ECHO SHI, I TWOANTD A CONFERENCE EARLIER THIS YEAR ABOUT OPEN PEER REVIEW AND THIS IS OPEN PEER REVIEW IN JOURNALS AND THE IDEA WAS THAT THIS WOULD ENHANCE THE QUAWLTD OF THE SCIENTIFIC WORK THAT WAS TO BE PRODUCED. I THINK IT'S A VERY INTRIGUING IDEA BUT ONE OF THE POINTS THAT WE MADE IS THAT IF ONLY 2% OR 1% OF PAPERS ARE REPORTING OUT SAMPLE SIZE OR REPORTING OUT DATA MANAGEMENT, YOU'RE GOING TO HAVE A PROBLEM WITH PEER REVIEW BECAUSE THE PIESHZ AREN'T PAYING ATTENTION TO THIS, SO WHAT THAT MEANS IS THAT SOMETHING ELSE HAS TO HAPPEN TO DRAW ATTENTION ON THE IDEA THAT HAVING A METHODOLOGICALLY ROW BUSES STUDY -- ROBUST STUDY, HAVING ADEQUATE SAMPLE SIZE, ADEQUATE RANDOMIZATION, ADEQUATE BLINDING , WHATEVER IS APPROPRIATE FOR THAT KIND OF WORK NEEDS TO BE THOUGHT THROUGH AND THEN WE HOPE THAT OUR REVIEWERS ARE ABLE TO MAKE AN APPROPRIATE JUDGMENT WITHIN THE CONTEXT OF THE SCIENCE THAT'S BEING PROPOSED. >> THANKS, MIKE. TWO QUESTIONS. ONE IS, I WAS NOTED THAT IN ONE OF YOUR EARLIER SLIDES, THE EXTRA FORM IS GOING TO BE ABOUT CHEMICAL AND BIOLOGICAL AUTHENTICATION, BUT WHY NOT DATA AUTHENTICATION AND DATA PROVIDENCE? IS THAT SOMETHING THAT CAN BE INCLUDED? IT SEEMS THAT UNDERSTANDING FROM WHERE THE DATA CAME AND THE STANDARDS THAT WE USED TO MANAGE THAT DATA WOULD BE IMPORTANT. >> YEAH, SO THAT'S AN IMPORTANT PART, AND THIS WAS SOMETHING THAT SHI MENTIONED IN HIS PAPER IS THAT A CRITICAL ELEMENT OF RIGOROUS WORK, BE IT CLINICAL OR PRECLINICAL IS APPROPRIATE DATA MANAGEMENT. AND SO FOR EXAMPLE ONE STORY I LOVE TO TELL IS WHERE A SCIENTIST WAS PRESENTING HIS WORK AND IT WAS VERY EVIDENT THAT A NUMBER OF OBSERVATIONS HAD BEEN, ANIMAL OBSERVATIONS HAD BEEN LOST TO FOLLOW-UP BUT HAD NOT BEEN TAKEN INTO ACCOUNT, ESSENTIAL MISSING DATA THAT WAS COMPLETELY IGNORED. AND WHAT WAS INTERESTING WAS THAT NOT TO PUT ANY FAULT, BUT IT WASN'T APPRECIATED THAT THIS WAS A PROBLEM. SO I THINK YOU RAISE A REALLY INTERESTING POINT, THAT THAT'S AN IMPORTANT PART OF RIGOR IS HOW WILL THE DATA BE MANAGED, HOW WILL MISSING DATA BE HANDLED , HOW WILL OUTLIERS BE APPROACHED, HOW WILL DATA BE SHARED, THESE ARE SOME OF THE ISSUES THAT NEED TO BE CONSIDERED. IN THE PCORI METHODS STANDARDS, THERE ARE SPECIFIC METHODS STANDARDS ON DATA MANAGEMENT, AND MUCH OF THAT DATA MANAGEMENT WOULD BE APPLICABLE NOT ONLY TO OUTCOMES RESEARCH BUT ALSO TO PRECLINICAL RESEARCH. >> ANOTHER QUESTION. SO I WAS THINKING ABOUT THIS, YOU KNOW, HOW DO YOU ELEVATE THE UNDERSTANDING OF RIGOR FROM THE POINT OF VIEW OF THE GRANT APPLICANTS, AND I WONDER IF THERE'S AN OPPORTUNITY FOR NIH TO PARTNER WITH THE JOURNAL EDITORS TO BASICALLY SAY, YOU KNOW, WE HAVE A COMMON STANDARD, THAT WE'RE ONLY GOING TO PUBLISH PAPERS THAT ALSO HIGHLIGHT THE STRENGTHS AND WEAKNESSES OF THE PRIOR LITERATURE AND THAT REALLY SHOW THE KINDS OF SAMPLE SIZE CALCULATIONS, EVERYTHING YOU MENTIONED. IT SEEMS LIKE THE QUALITY OF THE JOURNAL ARTICLES AND THEIR REPRODUCIBILITY WOULD BE ENHANCED IF THAT WERE THE CASE. >> SO JEFF, IN FACT, FRANCIS AND I ALONG WITH OTHERS DID JUST THAT, WE HAD AN INTERESTING MEETING WITH JOURNAL EDITORS AND I FORGET HOW MANY THERE WERE, LIKE -- >> A LOT. >> NATURE AND SCIENCE GO -- >> RIGHT. GETTING 50-PLUS JOURNAL EDITORS TO AGREE TO A SINGLE DOCUMENT THAT THEY ALL WANTED TO EDIT WAS A CHALLENGE. [LAUGHTER] BUT WHAT'S FASCINATING, AND I'M NOT GOING ON BASH PARTICULAR JOURNALS, BUT LTS TRUE THAT -- BUT LITTLE TRUE THAT NOW THERE'S BEEN A STEP FORWARD AND WHEN THEY ARE PUBLISHING AN ARTICLE WHERE THE N IS 1, THEY ARE NOW SAYING THAT THE N IS 1, BUT THEY'RE STILL PUBLISHING THE ARTICLE. AND THAT'S A LITTLE SCARY OF COURSE, BUT I THINK -- AND AGAIN , IT'S IN THEIR MINDS, AND I DON'T KNOW IF THERE ARE ANY JOURNAL EDITORS HERE, BUT IF THERE ARE, SPEAK UP AND DEFEND YOURSELVES, BUT IT'S A BALANCE BETWEEN NOT MISSING THAT INCREDIBLY IMPORTANT EXCITING THING VERSUS MAKING SURE THAT IT'S REAL, AND I KNOW I'M BEING PEJORATIVE IN HOW I'M DESCRIBING THIS, BUT THAT WAS THE SENSE OF WHAT THE JOURNAL EDITORS, SOME OF THE JOURNALS SAID, THAT WE'RE ALMOST WILLING TO TAKE A GAMBLE BECAUSE WE'RE CUTTING EDGE, WE HAVE TO PUBLISH THE MOST IMPORTANT AND CREDIBLE STUFF. AND WHILE I THINK MANY PEOPLE WOULD RATHER BE A LITTLE BIT MORE BORING AND KNOW THAT WHAT THEY HAVE IS ABSOLUTELY SOLID. >> I DO THINK, ANY OF YOU WHO ARE SUBMITTING PAPERS TO THESE JOURNALS IN THE LAST TWO OR THREE YEARS WILL NOTICE YOU GET ASKED THESE QUESTIONS MORE THAN YOU'RE USED TO ABOUT EXACTLY WHAT WAS THE NATURE OF THE RE AGENT, IS YOUR EXPERIMENTAL PLAN ACTUALLY FULLY DETAILED? IF NOT, WE NEED TO HEAR THAT BEFORE THIS IS GOING TO BE ACCEPTABLE. AND THOSE SORTS OF QUESTIONS, WHICH CAME DIRECTLY OUT OF THIS AGREED UPON EFFORT TO AT LEAST TRY TO CLARIFY WHAT EXPERIMENT DID YOU DO THAT YOU NOW WANT US TO PUBLISH? I DON'T THINK THEY QUITE GOT TO THE LEVEL OF INSISTENCE ON STWAT -- STATIS TICAL CLARITY THAT ONE MIGHT HAVE LIKED IN SOME INSTANCES. BUT IT WAS A STEP FORWARD. >> THEY DO FOR EXAMPLE, THE NATURE JURMS NOW HAVE -- JOURNAL SAYS NOW HAVE A WHOLE SERIES OF QUESTIONS AND THERE ARE BOXES THAT YOU FILL IN AND THEN WHEN THE ARTICLE IS ACTUALLY PUBLISHED YOU CAN SEE WHAT WAS ACTUALLY PUT IN THERE, SO THERE IS ACTUALLY A QUESTION SAYING JUSTIFY THE SAMPLE SIZE, HOW WAS IT CALCULATED AND JUSTIFY THE SAMPLE SIZE. NOW, WHAT WE'VE SEEN IS WE SEE EXAMPLES WHERE WHAT'S WRITTEN IN THERE IS THE SAMPLE SIZE WAS BASED ON PREVIOUS PAPERS, BUT TO BE FAIR AT LEAST A QUESTION IS BEING ASKED AND THEN A DISCERNING READER CAN LOOK AT THAT AND DECIDE WHAT THEY THINK BASED ON THAT. ONE OF THE EDITORS TALKED TO ME ABOUT THIS AND SAID EVENTUALLY THEY'LL GET TO A POINT WHERE IF YOU WERE TO GIVE AN ANSWER LIKE THAT, WE WOULD STOP. UNLESS THERE WAS SOME OTHER REALLY SUPER-COMPELLING REASON TO PRESENT THE PAPER. BUT, YOU KNOW, THAT IS DEFINITELY A STEP IN THE RIGHT DIRECTION. >> JUST FROM A PERSPECTIVE OF HAVING FILLED OUT THOSE CHECKLISTS MANY TIMES, I QUESTION THEIR VAWFL AT SOME LEVEL -- VIETNAM AT SOME LEVEL MENT I FEEL -- I QUESTION THEIR VALUE AT SOME LEVEL. THE CHECKLIST YOU'RE SEEING IS PROBABLY REPRESENTATIVE OF MOST OF THE ONES THAT ARE THERE AND I'M GLAD YOU DIDN'T ADD ANY MORE PAPERWORK HERE BUT I THINK IT ALSO UNDERSCORES A POINT WHICH IS THAT I FIND IT UNLIKELY THAT MOST INVESTIGATORS WOULD BE CONFRONT WD THAT CHECKLIST AND BE LIKE OH, MY GOD, I HAVEN'T BEEN RIGOROUS, RIGHT? PEOPLE WILL FIND A TWIE ANSWER AND I THINK THAT JUST HIGHLIGHTS PARAMOUNT MORE THAN ANYTHING IS THE TRAINING ASPECT AND JUST IN INSTILLING MORE OF THAT SPHIRT OF RIGOR AS EARLY AS POSSIBLE. I REMEMBER BEING TREMENDOUSLY AFFECTED IN GRADUATE SCHOOL BY THESE ETHICS TRAINING COURSES AND JUST SEEING ALL THE EXAMPLES OF WHEN IT CAN GO WRONG WHEN YOU'RE THAT NEW TO ALL OF THIS AND I THINK EXPOSING PEOPLE TO THOSE EXAMPLES AS EARLY AS POSSIBLE JUST KIND OF WOULD GO A LONG WAY TOWARDS THEIR WHOLE CAREER, MORE SO THAN THESE THINGS DOWN THE LINE. >> I THINK PEOPLE WILL, YOU KNOW , IF YOU'VE NEVER DONE A POWER POPULATION BEFORE FOR ANIMAL EXPERIMENT AND THEN YOU HAVE A CHECKLIST THAT SAYS WE WILL NOT BE SCORING YOU FAVORABLY UNLESS YOU DO POWER CALCULATIONS FORCES YOU TO LEARN ABOUT POWER CALCULATIONS AND USE THEM. YEAH, YOU CAN GAIN POWER CALCULATION AND EFFECT SIZE AND EXPECTING THIS MUCH AND WHATEVER , BUT IN THE VERY LEAST IT IS A STEP IN THE RIGHT DIRECTION, I THINK. >> I AGREE, BUT I THINK THAT YOU HAVE A CULTURE OF DOING THINGS A CERTAIN WAY IN CERTAIN FIELDS THAT WILL BE VERY HARD TO CHANGE UNLESS YOU APPROACH IT AT THE TRAINING STAGE. >> FRANCIS, I RECALL YOU GETTING A LOT OF SUPPORT IN TERMS OF HEADS OF R AND D FROM PHARMACEUTICAL COMPANIES IMPROVING RIGOR. I JUST WON DERP A QUESTION WHETHER YOU RECEIVED ANY USEFUL COMAMPLEZ -- USEFUL EXAMPLES, BACK TO THE POINT ABOUT THERE IS A PRICE TO PAY IF YOU GET FOUND OUT LATER ON AND I WONDER WHETHER THERE WOULD BE SOME USEFUL EXAMPLES THERE. I ALSO WONDER WHETHER THIS HAS ANYIES IMPLICATIONS FOR THE REGULATORY SYSTEM AND WHETHER AT SOME POINT, AGAIN, I WOULD HOPE, AND I DON'T KNOW THIS FOR A FACT , BUT I WOULD HOPE THAT THE PHARMACEUTICAL INDUSTRY IS A LITLE BIT AHEAD OF THIS ON THIS BECAUSE OF BEING HIGHLY REGULATED HAD, BUT I WONDER IF THERE'S A PROCESS HERE TOGETHER WITH THE FDA THAT MY MIGHT -- THE WRITING -- THE RISING TIDE MIGHT RISE ALL BOATS. >> GREAT POINTS. OF COURSE ONE OF THE THINGS THAT BROUGHT TO THE ATTENTION OF NIH GRANT TEL EES AND TOWPS AT NIH ABOUT THIS ISSUE PARTICULARLY FOR ANIMAL MODELS WERE REPORTS FROM INDUSTRY ABOUT THE FAILURE TO BE ABLE TO REPLICATE THE VAST MAJORITY OF ANIMAL MODEL INTERVENTIONS WITH VARIOUS COMPOUNDS WHICH THEN LED IN SOME INSTANCES TO INITIATING A HUMAN CLINICAL TRIAL THAT TURNED OUT TO BE BASED UPON TOTAL FANTASY, WHICH IS REALLY HARD TO LOOK AT AND NOT SAY THIS IS WRONG, NOT ONLY WE WASTED A LOT OF MONEY, WE ACTUALLY ASKED PEOPLE TO BARPT IN A TRIAL HA MIGHT HAVE PLACED DAIRVE TO PARTICIPATE IN A TRIAL THAT MIGHT HAVE PLACED THEM AT SOME RISK FROM WHICH THE RATIONAL BASIS WAS LACKING. THAT WAS A WAKEUP CALL THAT OCCURRED. MY SENSE FROM THE CONVERSATIONS WITH R AND D THAT GENERALLY THE INDUSTRY MUCH MORE RIGOROUS ABOUT THE DESIGN OF THESE STUDIES BECAUSE OF THE STRONG REALIZATION OF JUST HOW HIGH THE STAKES ARE FOR FALSE-POSITIVES AND ALSO THE REALIZATION THAT THE REGULATORS ARE GOING TO LOOK REALLY HARD AT THE DATA. MOST ACADEMICS, IF I CAN SAY, I THINK PART OF THE REASON WE'RE IN SUCH A DIFFICULT POSITION RIGHT NOW IS A LOT OF THESE ANIMAL MODEL EXPERIMENTS ARE BEING DONE BY INDIVIDUALS WHO HAVE NOT DONE THEM BEFORE, THEY BASICALLY WORKED IN A PARTICULAR AREA OF BIOCHEMISTRY OR MOLECULAR BIOLOGY, THEY'RE EXCITED ABOUT THE IDEA TO BECOME TRANSLATIONAL SCIENTISTS, AND WE ALL ARE, THEY FIND THAT OH GOSH I'VE DISCOVERED THE CAUSE OF THIS GENETIC DISEASE, I CAN MAKE A MOUSE MODEL AND THEN FIGURE OUT HOW TO CURE IT AND THEN THIS WHOLE PROCESS OF HOW FAR TO SET UP THE EXPERIMENT RIGOROUSLY AND HOW GOOD THAT DATA IS GOING TO HAVE TO BE IF YOU'RE EVER GOING TO GO TO FDA AND CONVINCE THEM THAT YOU HAVE THE BASIS FOR AN I ND, THAT KIND OF THOUGHT PROCESS HAS NOT HAPPENED. TRAINING CLEARLY IS GOING TO BE CRITICAL. I'M WANT QUITE AS READY TO GIVE UP THOUGH ON THE PEOPLE WHO HAVE BEEN ALREADY OUT THERE WHO ARE NO LONGER GRADUATE STUDENTS OR POST-DOCS BECAUSE I DO THINK THERE IS SOME CHANCE OF SOME RE RETRAINING OF THOSE INDIVIDUALS AS WELL AND SOMETIMES THAT'S WITH AIR A CARROT AND SOMETIME IT'S A STICK, MAYBE I'M NOT QUITE AS WILLING TO GIVE UP ON THE CHECKLIST FOR THIS VERY SPECIFIC AREA OF ANIMAL MODELS OF HUMAN DISEASE THAT ARE BEING USED AS A PREMISE FOR BUILDING A CASE FOR A HUMAN CLINICAL TRIAL BECAUSE I JUST KNOW HOW CRUCIAL THOSE ARE IN TERMS OUR RESPONSIBILITY TO HUMAN PATIENTS , AND I KNOW FROM AT LEAST THE PAST HOW MUCH MONEY WE HAVE WASTED ON THOSE KINDS OF EXPERIMENTS THAT WERE BADLY DESIGNED, PROBABLY GOT PUBLISHED SOMEWHERE, MOST OF THEM DID, AND MOST OF THEM WERE NOT ADDING MUCH TO THE KNOWLEDGE OF WHAT WE NEED TO DO. IF WE COULD FIX THAT ONE AREA, PRETTY IMPORTANT.E SOMETHING >> I WOULD LIKE TO COME BACK TO YOUR POINT, JAY, ABOUT THE NEED FOR MORE TRAINING. SO NIH HAS DONE AT LEAST SOME THINGS IN THIS SPACE, JOHN WALSH COULD PROBABLY SUMMARIZE SOME OF THE THINGS THAT GM HAS DONE AND MAYBE WE COULD INVITE HIM TO DO THAT, BUT I GUESS MY QUESTION IS , SO WE'VE BEEN DOING SOME OF THESE THINGS, BUT APPARENTLY DOES THE FIELD EVEN KNOW THAT WE'VE BEEN DOING THESE THINGS, DOES ANYBODY EVEN PAY ANY ATTENTION? SO INTERNALLY WE DID SOME VIGNETTE SAYS WITH ACTORS OREGON PEOPLE WHO WERE AN ACTOR FOR A DAY AND THEN HAVE STUDY GUIDE MATERIAL, WE DID SOME THINGS, WORKSHOPS WITHIN THE INTRAMURAL PROGRAM, JOHN, MAYBE IF YOU COULD JUST COMMENT ON THE STUFF THAT JIM HAS BEEN DOING SPECIFICALLY. >> MIKE OUTLINES THE NEW FOA WHICH HAS RIGOR AND REPRODUCIBILITY REALLY THROUGHOUT IT AND HE MENTIONED THE TRAINING MODULES WHICH WILL WE'VE HAD ONE FOA AND ANOTHER ONE OUT RIGHT NOW FOR. THE ADDITIONAL AREA WHICH MAYBE WOULD GIVE YOU SOME HOPE, LARRY S WE'RE NOW ON OUR THIRD YEAR OF GIVING ADMINISTRATIVE SUPPLEMENTS TO EXISTING T32'S TO IMPROVE TRAINING IN EXPERIMENTAL DESIGN OR OTHER AREAS RELATED TO RIGOR AND REPRODUCIBILITY, THEY'VE BEEN VERY, VERY POPULAR. I DON'T KNOW THE EXACT NUMBER WE'VE GIVEN SO FAR ACCIDENT BUT IT'S DOZENS -- SO FAR, BUT IT'S DOZENS AND THERE'S A LOT OF DEMAND FOR THEM. SO I THINK ATTENTION IS STARTING TO BE GAINED. >> AGAIN, THE QUESTION BACK TO THE ACD TO JAY AND TO OTHERS, WHAT MORE SHOULD WE BE DOING TO GET THE WORD OUT? BECAUSE THERE HAVE BEEN MULTIPLE EFFORTS TO TRY AND PROVIDE MATERIALS, YOU KNOW, THAT ARE READILY ACCESSIBLE FREE AND COULD BE ADAPTED TO WHATEVER, YOU KNOW, YOUR LOCAL ENVIRONMENTS ARE. WHAT MORE CAN WE DO? WHAT WOULD WORK BETTER? >> IS THERE CURRENTLY A REQUIRED MINI COURSE IN THE CONTEXT OF TRAINING GRANTS AND F GRANTS THAT THE WAY THERE IS FOR ETHICS ? AND RESPONSIBLE CONDUCT? AS A REQUIREMENT. >> SO THAT'S PART OF THE NEW FOA >> THEN I THINK HOPEFULLY IT WILL BE MADE N I H-WIDE. >> FRANCIS, I DO THINK THAT IT IS A GENERATIONAL ISSUE BECAUSE I DO THINK THE AMAZING DISCOVERIES OF THE '80S AND '90S , I CERTAINLY GREW UP IN THAT GENERATION WHERE IT WAS MOLECULAR BIOLOGY, WHERE THERE WERE NO STATISTICS, TEFORTS A G, A, T OR A C AND SAMPLE SIZE WAS ALWAYS ONE. [LAUGHTER] THAT ACTUALLY AFFECTED A WHOLE GENERATION OF EXACTLY, SO I DO THINK THERE'S HOPE THAT BECAUSE OF -- EXACTLY. IT'S ALL OUR FAULT. BUT BECAUSE OF THE TRAINING THAT IS IN PRARKS I DO THINK WE'LL SEE BAYS BECAUSE IT IS AS DIFFERENT GENERATION COMING TO THE NEXT SORT OF PHASE. >> ANY OTHER COMMENTS ON THIS TOPIC, WHICH OBVIOUSLY IS ONE WE'LL CONTINUE TO WRESTLE UNTIL WE WHERE HE IS ELT IT TO THE GROUND, BECAUSE IT'S -- WRESTLE IT TO THE GROUND, BECAUSE IT'S IMPORTANT. IF NOT, WE HAVE TIME FOR A BREAK FOR THE NEXT OH, LET'S SAY 18 MINUTES THEN WE'LL RECONVENE AT 3:00. WE'RE GOING TO HEAR FROM LARRY TABAK ON BEHALF OF A BUNCH OF OTHER FOLKS THAT YOU SEE LISTED IN THE AGENDA ABOUT AN EFFORT THAT'S BEEN UNDERWAY AT NIH FOR SOME TIME IN WHICH WE THOUGHT THE ACD SHOULD HEAR ABOUT IN TERMS OF OUR EFFORTS TO TRY TO ADDRESS TO THE SERIOUS ISSUES OF SEXUAL AND GENDER HARASSMENT. THIS IS SOMETHING WE'VE BEEN WORKING ON FOR QUITE SOME TIME, IT'S OBVIOUSLY BECOME A TOPIC OF INTENSE PUBLIC ATTENTION AS WELL IT SHOULD BASED ON VARIOUS REVELATIONS UPON THE ADVENT OF THE ME TOO INITIATIVES WITH THE NATIONAL ACADEMY REPORT COMING THIS WEEK, LARRY WILL TELL YOU ABOUT WHERE WE ARE RIGHT NOW. I HAVE TO TELL YOU A COMMENT RIGHT NOW ABOUT I AM EMBARRASSED BY THE FACT THAT OUR CD IS SO GENDER IMBALANCED AND THIS IS SOMETHING THAT WE ARE WORKING ON TO TRY TO CORRECT. WE HAVE LOST SOME OF OUR WOMEN MEMBERS AND WE'VE NOT BEEN SUCCESSFUL IN FIGURING OUT HOW BEST TO ADDRESS THAT AND LET ME ASSURE YOU AS NIH DIRECTOR WE'LL MAKE THAT A PRIORITY OF THE HIGHEST MATTER BOTH IN TERMS OF DIVERSITY IN TERMS OF SEX AND GENDER AS WELL AS OTHER DIVERSITY THAT IS NOT AS WELL REPRESENTED AT THE PRESENT TIME AT IT SHOULD BE. WITH THAT, LARRY. >> THANK YOU, FRANCIS, GOOD AFTERNOON, EVERYBODY. AS FRANCIS HAS INDICATED, I'M JUST THE SPOKESPERSON, THIS HAS REALLY BEEN A TEAM SPORT, AND PROBABLY A THIRD IF NOT A HALF OF THE PEOPLE IN THIS ROOM HAVE MADE VARIOUS CONTRIBUTIONS TO WHAT I WILL SHARE WITH YOU TODAY AND SO FIRST I WOULD LIKE TO FRAME THE ACTIVITIES WITH A BRIEF INTRODUCTION, THEN DESCRIBE FOR YOU SOME OF THE ISSUES SURROUNDING THE EXTRAMURAL WORKFORCE IN SEXUAL HARASSMENT. THIRDLY, TO TALK ABOUT THE NIH WORKFORCE AND REALLY TRY AND JOWLT LINE FOR YOU SOME OF THE PROGRAMS AND TOOLINGS AND THE WORK TOWARDS POLICIES TO PREVENT AND ADDRESS HARRISMENT IN THE WORKPLACE AND THEN OF COURSE WE HOPE TO HAVE A GOOD DISCUSSION SO BY WAY OF INTRODUCTION, THERE HAVE BEEN A MYRIAD OF CALLS TO ACTION, IF YOU WILL AND I AM SURE THAT YOU HAVE ALL READ MANY REPORTS WHICH ARE VERY DISTRESS ING, VERY DISTURBING, VERY DISHEARTENING ABOUT THIS. I THINK JUST FROM A POLICY STANDPOINT, WE JUST CAN'T AFFORD TO LOSE SOME OF ITS BEST TALENT TO BORRISHNESS, IT GOES BEYOND THAT, BUT FROM A PRACTICAL STANDPOINT, I THINK THIS IS A VERY, VERY TRUE THING AND THIS COMMENT SEXUAL HARASSMENT IS A STAIN ON SCIENCE, WE MUST ALL TAKE A STAND AGAINST IT. THERE ARE MANY, MANY DATA THAT ONE COULD POINT TO, JUST A COUPLE OF EXAMPLES, THIS IS FROM THE REPORT THAT WAS JUST RELEASED THIS WEEK, EARLIER THIS WEEK FROM THE NATIONAL ACADEMY, WHICH I WILL COME BACK TO IN A MOMENT, WHERE THEY REPORT OUT DATA THEY CALLED FROM A UNIVERSITY OF TEXAS STUDENT SURVEY AND OVERALL 20% OF STUDENTS, THAT IS BOTH MALE AND FEMALE, REPORTED HARASSMENT BY FACULTY OR STAFF AND THEN WHEN YOU LOOK ONLY AT THE FEMALE RESPONDENTS, 22% REPORTED HARRIS MENT. NOW, THAT UNDERSCORES AN IMPORTANT POINT. WE SORT OF REFLEXIVELY THINK THAT ALL THE HARASSMENT SK PERPETRATED AGAINST FEMALES, AND THAT IS JUST NOT ACCURATE. IT'S HEINOUS NO MATTER WHAT, BUT JUST TO UNDERSCORE THAT IT IS A PROBLEM FOR BOTH SEXES. THE NUMBERS ARE STUNNING WHEN YOU LOOK AT DIFFERENT STAGES. STUDENT BODY. AGAIN, THIS IS BOTH EXPHAIL FEMALE, YOU KNOW, AROUND 20% OF BOTH UNDERGRADS AND GRADUATE STUDENTS REPORT HARRISMENT BUT LOOK AT THE INCREDIBLE PERCENTAGE AMONGST MEDICAL STUDENTS, WE SPENT AT LEAST SOME TIME TRYING TO UNDERSTAND THAT AND I THINK SOME HAVE OFFERED THAT BECAUSE OF THE HIERARCHICAL NATURE OF MEDICAL SCHOOLS AND THEIR TRAINING THAT THAT LENDS ITSELF TO THIS UNFORTUNATE AND INTOLERABLE SITUATION AND IT WOULD BE INTERESTING TO HEAR FROM THE ACD THEIR REFLEXES. THIS IS DATA FROM AN ARTICLE PUBLISHED IN JAMA A COUPLE YEARS AGO AND THIS LOOKS AT KOA AND K 23 AWARDEES, THESE ARE ALL FEMALES AND WHAT IT BREAKS DOWN ARE THE NATURE OF THE HARASSMENT , THE NATURE OF THE MISEXPERIENCES, IF YOU WILL. AND AS YOU CAN SEAL THERE ARE A SIGNIFICANT NUMBER OF COERCIVE ADVANCES, THERE ARE THREATS, THERE'S A SUBTLETY OF BRIBERY TO ENGAGE IN SEXUAL BEHAVIOR BUT THESE TWO CATEGORIES WHICH, YOU KNOW, SOMETIMES WE KIND OF DISMISS AS OH, THAT'S JUST PEOPLE BEING PEOPLE OR THAT'S CULTURAL OR, I MEAN, WE COME UP WITH ALL KINDS OF EXCUSES, BUT THIS IS A REMARKABLE PERCENTAGE AND THE REASON I'M EMPHASIZING THAT IS BECAUSE OF SOME OF THE FINDINGS IN THIS NATIONAL ACADEMY REPORT THAT WAS JUST RELEASED AND I'LL COME BACK TO THAT IN JUST A MOMENT. SO MIKE VALOR, HANNA VALENTINE AND FRANCIS, IN A NOTE TO NATURE , ARTICULATED THE AGENCY VIEW THAT WE ARE BOTH DEEPLY CONCERNED ABOUT SEXUAL HARASS MENT, THAT WE NEED TO DO WHAT WE CAN TO END THIS AT ALL N IH SUPPORTED WORK PLACES AND SCIENTIFIC MEETINGS, THESE EXPECTATIONS WERE STATED LAST FALL WITH THE EXPECTATION THAT N IH SUPPORTED CONFERENCES AND MEETINGS SHOULD ENSURE A SAFE ENVIRONMENT FREE OF DISCRIMINATION WE ARE OF COURSE NOW WORKING BROADLY TO TRY AND COME UP WITH SOLUTIONS AND OF COURSE AN IMPORTANT STEP IS TO UNDERSTAND THE NATURE AND THE EXTENT OF THE PROBLEM WHICH WILL OF COURSE GUIDE US GOING FORWARD AND WE ARE WORKING HARD AT DELIVERING ON WHAT HAS BEEN OUT LINED IN THIS BRIEF NOTE. IT TURNS OUT THIS REPORT WAS RELEASED EARLIER THIS WEEK, AND IT IS A VERY IMPORTANT REPORT. THE CUMULATIVE EFFECT OF SEXUAL HARASSMENT IS A SIGNIFICANT AND COSTLY LOSS OF TALENT IN ACADEMIC SCIENCE, ENGINEERING AND MEDICINE WHICH HAS CONSEQUENCES FOR ADVANCING THE NATION'S ACADEMIC AND SOCIAL WELL-BEING AND ITS OVERALL PUBLIC HEALTH. APART FROM ALL THE OTHER REASONS WHY WE NEED TO ADDRESS THIS, THERE IS THIS REASON WHICH IS UNDERARTICULATED AND I THINK THIS REPORT DOES A REALLY EXCELLENT JOB OF BLIG THAT TO THE FLOOR. THE REPORT ALSO EX-PLIMS ITLY DESCRIBES THREE FORMTZ OF SEXUAL HARASSMENT AND I CONFESS -- FORMS OF SEXUAL HARASSMENT, AND I CONFESS, I WAS REALLY ONLY COGNIZANT OF TWO, YOU KNOW, THAT IF SOMEBODY WOULD SAY WHAT'S SEXUAL HARASSMENT, IMED REFLEXIVELY SAY, WELL, UNWANTED SEXUAL ATTENTION, AND I WOULD REFLEXIVELY SAY, YOU KNOW, COERCION. BUT CONFESS MY OWN PERSONAL IGNORANCE OF THIS THIRD CATEGORY WHICH TURNS OUT TO BE SO VERY, VERY OCCASIONAL BECAUSE IT ENABLES THESE -- VERY, VERY CRUCIAL BECAUSE IT ENABLES THESE OTHER ACTIVITIES, GENDER HARASS MENT, THAT IS SEX AS HOSTILITY AND CRUDE BEHAVIOR. THINK BACK TO THE SURVEY. K AWARDEES, 92 OR 93% WERE SUBJECTED TO A FORM OF THIS AND I MUST SAY PERSONALLY AND I THINK MANY DON'T REALLY TAKE THIS ENVIRONMENTAL ISSUE OF GENDER HARASSMENT AS SERIOUSLY AS WE MUST BECAUSE THIS IS WHAT SETS UP THIS FROM HAPPENING. SO AGAIN I CERTAINLY RECOMMEND THE REPORT IF YOU HAVEN'T SEEN IT. THIS IS THE SITE THAT YOU CAN INTERROGATE. AND I'M BUILT AM GIVING JUSTICE TO THE REPORT BY GIVING A SHORT SUMMARY OF SOME OF THE MAJOR FINDINGS, IT ASPHECTS MANY WOMEN IN SCIENCE, CUMULATIVE RESULT IS IT'S DAMAGING SCIENCE. IF WE DON'T ADDRESS THIS, WE ARE GOING TO CONTINUE TO DAMAGE THE SCIENTIFIC ENTERPRISE OF THIS NATION. AM WE ARE REQUIRE SYSTEMWIDE CHANGES TO CULTURE AND CLIMATE TO PREVENT HARASSMENT AND SO AGAIN THERE ARE WAYS OF DIFFUSING HIKER ARC CAL ENVIRONMENTS THROUGH MENTORING NETWORKS AND COMMITTEE-BASED ADVISEMENT, BUT IF AND ONLY IF YOU REALIZE THAT THAT'S PART OF THE PROBLEM. AND OVER AND OVER AGAIN THE REPORT POINTS TO THE FACT THAT STRONG AND DIVERSE LEADERSHIP IS ESSENTIAL TO PROMOTING THE CULTURAL CHANGES AND THE CLIMATE CHANGES THAT ARE NEEDED. NOW, THERE'S A SPECIFIC SECTION WHERE THERE'S A CALL OUT TO FUNDING AGENCIES SO AGAIN I'M HIGHLIGHTING THESE, THERE ARE MANY OTHER SECTIONS OF RECOMMENDATIONS BUT WE ARE JUST GOING TO SUMMARIZE STHEEZ FOR YOU QUICKLY, TO INCREASE SUPPORT FOR RESEARCH ON THE IMPACT OF SEXUAL HARASSMENT, TO ATTEND TO SEXUAL HARASSMENT WITH AT LEAST THE SAME LEVEL OF ATTENTION AND RESOURCES TO RESEARCH MIS MISCONDUCT. THAT'S A VERY INTERESTING STATEMENT. BECAUSE ALL OF US HAVE BEEN INTRODUCED AND THEN GAUGED WITH RESEARCH TRAINING AND ACTIVITIES SO WE REFLEXIVELY SAY CERTAIN THINGS ABOUT THAT BUT WE DON'T NECESSARILY SAY THOSE THINGS REFLEXIVELY WHEN WE TALK ABOUT SEXUAL HARASSMENT. REQUIRE INSTITUTIONS TO REPORT TO FEDERAL AGENCIES WHEN INDIVIDUALS ON GRANTS HAVE BEEN FOUND TO HAVE VIOLATED SEXUAL HARASSMENT POLICIES OR HAVE BEEN PUT ON ADMINISTRATIVE RELIEF RELATED TO SEXUAL HARASSMENT, I'LL COME BACK TO THAT IN A MOMENT ABOUT HOW NIH IS DEALING WITH THESE TYPES OF ISSUES AND FINALLY INCENTIVIZE COLLEGES AND UNIVERSITIES FOR IMPLEMENTING POLICIES, PROGRAMS AND STRATEGIES THAT RESEARCH SHOWS ARE MOST LIKELY TO AND ARE SUCCEEDING IN REDUCING AND PREVENTING SEXUAL HARASSMENT. INTERESTING RECOMMENDATIONS. SOME ARE A LITTLE PERHAP A LITTLE MORE PROVOCATIVE THAN OTHERS, BUT ALL RECOMMENDATIONS VERY, VERY WORTHY OF CONSIDERATION. NOW I WOULD LIKE TO TURN TO SOME MORE SPECIFIC INFORMATION FIRST BEGINNING WITH THE EXTRAMURAL WORKFORCE IN SEXUAL HARASSMENT AND PROVIDE THE NIH PERSPECTIVE, AND IT IS VERY, VERY IMPORTANT TO APPRECIATE AND UNDERSTAND THAT GRANTS AND CONTRACTS ARE AWARDED TO INSTITUTIONS AND NOT THEIR EMPLOYEES. AND SO THAT FRAMING PUTS CAN LIMITERS ON WHAT WE AS A FUNDING AGENCY OR MAY NOT DO. AWARDEES ARE RESPONSIBLE FOR THEIR EMPLOYEES, JUST AS, AND I'LL GET TO THIS IN A LITTLE WHILE, NIH IS RESPONSIBLE FOR ITS EMPLOYEES, FOR EXAMPLE THE PEOPLE WHO WORK IN THE INTRA MURAL PROGRAM, THE PEOPLE WHO WORK IN GRANTS AND SO FORTH, BUT IT IS AWARMED EES ARE -- AWARD HE'S ARE RESPONSIBLE FOR THEIR EMPLOYEES AND THEREFORE THE INSTITUTIONS ARE RESPONSIBLE FOR OBTAINING SAFE WORK ENVIRONMENTS. NOW, WE DO HEAR CONCERNS AND WHEN WE DO HEAR CONCERNS, WE MAY NOTE RELEVANT RESOURCES, INCLUDING THE OFFICE OF CIVIL RIGHTS AT THE DEPARTMENT OF HEALTH AND HUMAN SERVICES, WE MAY CONTACT VICE PRESIDENTS FOR RESEARCH, WE MAY CONTACT RESEARCH TEAMS AND WE MAY RENEGE OASH YAILT TERMS AND CONDITIONS, WHERE APPROPRIATE. , BUT FUNDAMENTALLY GRANTS AND CONTRACTS ARE AWARDED TO INSTITUTIONS, AND THAT'S NOT TO EMPHASIZE THAT AS A WAY OF SAYING NO, THAT'S NOT OUR RESPONSIBILITY, BUT IT'S A WAY OF UNDERSCORING THE ABSOLUTE NEED FOR UNIVERSITIES TO WORK VERY, VERY CLOSELY WITH ALL FUNDING AGENCIES BUT OF COURSE WE'RE TALKING ABOUT NIH HERE. BECAUSE IF THERE'S NOT THAT MUTE YOU'LL TRUST, IF THERE'S NOT THAT MUTUAL ENGAGEMENT, THEN THINGS THAT ARE UNTOWARD CAN GO UNCHECKED. IT'S JUST THAT SIMPLE. SO THAT'S REALLY THE REASON WHY I AM EMPHASIZING THIS. NOW, WE HAVE, IN FACT, PUBLISHED EXPECTATIONS FROM NIH IN A GUIDE NOTICE TALKING SPECIFICALLY IN THIS INSTANCE ABOUT TITLE IX, THE REGULATIONS APPLY, EDUCATIONAL PROGRAMS OR ACTIVITIES SUPPORTED BY THE NIH, IT PROTECTS MALE AND FEMALE STUDENTS, TRAINEES, INVESTIGATOR S, FELLOWS, POST-DOC S AND PARTICIPANTS IN EDUCATIONAL PROGRAMS OR ACTIVITIES FROM DISCRIMINATION AND UNLAWFUL SEXUAL HARASSMENT, SEXUAL VIOLENCE AND SEXUAL ASSAULT. AND WE HAVE PUBLISHED THIS AS A REMINDER TO THE COMMUNITY. NOW, AGAIN, AND THIS IS SLIGHTLY MORE SPECIFIC THAN WHAT AN ORIGINAL VERSION THAT I PROVIDED TO YOU BECAUSE WE WANTED TO GIVE YOU MORE PRECISION, SO I DON'T KNOW IF THEY WERE SWAPPED OUT OR NOT, BUT BECAUSE OF THE LAW, THERE ARE DIFFERENT SETS OF ELEMENTS THAT NEED TO BE CONSIDERED. SO IN EDUCATION, SEXUAL HARASSMENT IS ACTIONABLE UNDER TITLE IX WHERE IT IS SO SEVERE, PERVASIVE AND OBJECTIVELY OFFENSIVE THAT IT UNDERMINES AND DETRACTS FROM THE VICTIMS' EDUCATIONAL EXPERIENCE SUCH THAT THE VICTIMS ARE EFFECTIVELY DENIED EQUAL ACCESS TO AN INSTITUTION'S RESOURCES AND OPPORTUNITIES. L AND IN EMPLOYMENT, IT'S UN LAWFUL WHEN IT IS SO SEVERE AND PERVASIVE THAT A REASONABLE PERSON WOULD CONSIDER IT A HOSTILE OR INTIMIDATING WORK ENVIRONMENT OR WHEN ENDURING THE OFFENSIVE CONDUCT BECOMES A CONDITION OF CONTINUED EMPLOYMENT OF. SO AMONG THE ACTIONS CONTRIBUTING TO SEXUAL HARASSMENT ACCIDENT UNWELCOME SEXUAL ADVANCES OR REQUESTS FOR SEXUAL FAVORS, OTHER VERBAL OR PHYSICAL HARASSMENT OF A SEXUAL NATURE, OFFENSIVE REMARKS THAT ARE NOT OF A SEXUAL NATURE BUT ARE ABOUT A PERSON'S SEX, AND AGAIN SEXUAL HARASSMENT CAN BE COMMITTED BY MEN OR WOMEN AGAINST MEN OR WOMEN AND BY A SUPERVISOR OR A CO-WORKER OR NON EMPLOYEE. SO ALL OF THE ABOVE, WHEN THINKING THROUGH THESE ISSUES. NOW, AGAIN, NIH HAS TRIED TO, IN THE EXTRAMURAL SPACE, GET OUT IN FRONT OF THIS. HERE IS LANGUAGE ABOUT NIH SUPPORT FOR CONFERENCES AND SCIENTIFIC MEETINGS, SO-CALLED R 13 MECHANISM WHICH SOME OF YOU ARE FAMILIAR WITH, AND IN IT, IT SAYS UNAMBIGUOUSLY THAT CON SIS SENTENCE WITH FEDERAL CIVIL RIGHTS LAW AND GUIDELINES FOR HAD THE INCLUSION OF WOMEN, MINORITIES AND PERSONS WITH DISABILITIES AND NIH SUPPORTED CONFERENCE GRANTS POLICIES IS EXPECTED THAT ORGANIZERS OF NIH SUPPORTED CONFERENCES AND SCIENTIFIC MEETINGS TAKE STEPS TO MAINTAIN A SAFE AND RESPECTFUL ENVIRONMENT FOR ALL ATTENDEES BY PROVIDING AN ENVIRONMENT FREE FROM DISCRIMINATION AND HARASSMENT, SEXUAL OR OTHERWISE. SO WE EXPECT ANY CONFERENCE ORGANIZER TO ADHERE TO AND FOLLOW THROUGH WITH THESE PRINCIPLES. NOW, TO GIVE YOU SOME MORE TANGIBLE EXAMPLES, SOMETIMES WE HEAR THAT, YOU KNOW, DR. SO AND SO, WHO IS THE PRINCIPAL INVESTIGATOR OF A GRANT, HAS BEEN BANNED FROM COMING TO CAMPUS BECAUSE OF CONCERNS OF -- AND YOU CAN FILL IN THE EGREGIOUS ACTIVITY. THAT INSTITUTION HAS AN OBLIGATION TO INFORM US. IT'S A LITTLE DISHEARTENING, FRANKLY, TO LEARN ABOUT THIS BY READING STUDENT NEWSPAPERS. R THAT DO REPORT THIS VERY OFTEN AND OF COURSE IF WE LEARN OF AN INDIVIDUAL OR INDIVIDUALS WHO HAVE BEEN BANNED FROM CAMPUS BECAUSE OF THESE ISSUES, WE IMMEDIATELY CONTACT THE RELEVANT INSTITUTIONAL OFFICIALS BECAUSE IF THEY'RE NOT ALLOWED ON CAMPUS , HOW ON EARTH COULD WE ALLOW THEM TO AM OVERSEE AN NIH GRANT? IT MAKES ABSOLUTELY NO SENSE. SO IN THAT CASE, WE CAN RENEGOTIATE TERMS AND CONDITIONS BUT THIS UNDERSCORES WHY WE NEED THIS PARTNERSHIP, BECAUSE UNLESS WE KNOW ABOUT IT, UNLESS AN INSTITUTION LETS US KNOW ABOUT ONE OF THEIR EMPLOYEES, WE OFTEN DON'T KNOW. SO TO CLARIFY NIH'S POLICY ABOUT THIS, BECAUSE SADLY THERE HAVE BEEN AN UPTICK IN THESE TYPES OF CIRCUMSTANCES, AND IT COULD BE THAT THE NUMBERS WERE ALWAYS THERE BUT PEOPLE HAVE FORTUNATELY BEEN MORE FORTHCOMING ABOUT REPORTING T BUT THIS NOTICE WAS PUBLISHED, PRIOR APPROVAL IS REQUIRED ANYTIME THERE'S A CHANGE IN STATUS OF THE PI OR OTHER KEY PERSONNEL, PARTICULARLY CHANGES IN STATUS THAT WOULD INCLUDE RESTRICTIONS AT THE INSTITUTION I AM -- THAT THE INSTITUTION IMPOSES ON SUCH INDIVIDUALS AFTER THE TIME OF THE AWARD BECAUSE THESE CHANGES MAY IMPACT THE ABILIT OF THE PI OR THE OTHER KEY PERSON TOLL EFFECTIVELY CREDIBILITY TO THE PROJECT. IF YOU'RE BANNED FROM THE CAMPUS BECAUSE OF SEXUAL HARASSMENT, YOU CAN'T POSSIBLY FUNCTION AS A PI, AS A MENTOR, YOU CAN FILL IN THE LIST. AND WE CAN ALSO THINK THROUGH POTENTIAL CHANGES IN STATUS OF PEER REVIEW PARTICIPATION. SO AGAIN, I THINK YOU ALL APPRECIATE IT, SERVICE EXTERNAL REVIEWERS IS ARRANGED AT THE SOLE DISCRETION OF THE NIH, PEER REVIEW SERVICE PROVIDES NO ENTITLEMENT OF ANY TYPE, INCLUDING THAT EXPECTATION THAT PAST SERVICE WILL ENSURE ONGOING OR FUTURE SERVICE. AND THERE ARE MANY CONSIDERATIONS THAT NIH USES TO INFORM OUR DECISIONS ABOUT WHETHER THAT OFFER OF SERVICE SHOULD BE EXTENDED, AND THEY ARE PART OF THE AGENCY'S DELIBERATIVE PROCESS. SO THERE IS THAT ISSUE AS WELL. AND I WANTED TO SHIFT GEARS NOW AND TALK ABOUT THE NIH WORKFORCE THAT IS OUR EMPLOYEES. WELL, UP UNTIL NOW, I'VE JUST ADDRESSED ISSUES EXTERNAL TO THE NIH WHERE INSTITUTIONS HAVE THEIR EMPLOYEES AND WE WANT TO WORK IN PARTNERSHIP, BUT NOW LET'S TALK ABOUT THE NIH WORKFORCE. SO THIS SLIDE IS A VERY IMPORTANT ONE BECAUSE IT LISTS THE MEMBERS 31 AND ALL OF A REMARKABLE COMMITTEE THAT I'VE HAD THE PRIVILEGE TO COORDINATE, IT HAS THIS SOMEWHAT ODD NAME OF ANTI-HARRISMENT STEERING COMMITTEE -- ANTI-HARASSMENT STEERING COMMITTEE, EIGHT INSTITUTES AND CENTERS REPRESENTED, 14 DIFFERENT SPECIFIC STAKEHOLDER GROUPS, AND ALFRED JOHNSTON AND I TOGETHER WITH MIKE GOTTESMAN AND MIKE LAUER AND HANNA VALENTINE ARE TAKING TURNS IN TERMS OF WORKING THROUGH THESE ISSUES WITH THIS VERY LARGE GROUP OF TALENTED PEOPLE. S THE IMPORTANT PART OF THIS IS THESE ARE INDIVIDUALS FROM ALL DIFFERENT QUARTERS OF THE ORGANIZATION. IT JUST CAN'T BE A FEW PEOPLE IN THE IMMEDIATE OFFICE IS IT OF THE DIRECTOR DREAMING UP GREAT THOUGHTS. SO ON THE COMMITTEE ARE WORKING SCIENTISTS, ON THE COMMITTEE ARE WORKING ADMINISTRATORS, ON THE COMMITTEE ARE FOLKS WHO REALLY REPRESENT THE ENTIRE RANGE OF INDIVIDUALS AT NIH. AND IT HAS BEEN A VERY COMPLICATED SET OF DISCUSSIONS THAT WE'VE HAD BECAUSE SOME OF THESE CONVERSATIONS ARE NOT COMFORTABLE FOR EVERYBODY TO SAY OUT LOUD. BUT THESE ARE CONVERSATIONS THAT HAVE TO BE HAD. AND MORE IMPORTANTLY, THEN HAVE TO BE ACTED UPON. AND I THINK THIS GROUP, AND I HOPE YOU WILL AGREE WITH ME AS I SHARE THE PROGRESS TO DATE, HAS BEEN VERY EFFECTIVE IN THIS REGARD. SO ONE OF THE THINGS THAT WE ARE TRYING TO DO AS A GROUP IS WE ARE TRYING TO STRENGTHEN AND CENTRALIZE ALL ACTIVITIES THAT RESULT IN THE PREVENTION OF AND THE REDRESS OF HARASSMENT. , SEXUAL OR OTHERWISE. SO THE FIRST STEP IN TERMS OF THE OVERARCING PROCESS WAS TO ESTABLISH THIS COMMITTEE THAT I JUST SHARED WITH YOU, AND IT REALLY OVERSEES THE OVERALL PROCESS IMPROVEMENTS AND PROGRAM DESIGN. BUT THERE ARE MANY OTHER ELEMENTS, AND NEXT IS THE TEST TEST TEST TEST TEST. . . . . . . IN THE FEDERAL GOVERNMENT. [LAUGH] >> AND I -- AND I AMEMBARRASSED TO TELL YOU -- I AM ACRONYM TO WHAT IT WAS, AND SO WHAT DOES THIS ACRONYM STAND FOR? IT IS EXACTLY WHAT IT'S MEANT TO BE. CIVIL BEHAVIOR. BECAUSE IF YOU THINK ABOUT WHAT WE'RE TALKING ABOUT HERE, IF EVERYBODY WOULD ADOPT CIVIL BEHAVIOR, A LOT OF THIS ISSUE WOULD RESOLVE ITSELF. AND SO THE OFFICE OF HOME RUNS CIVIL PROGRAM HAS BEEN -- H.R. CIVIL PROGRAM HAS BEEN EXPANDED TO ADDRESS ALL ALLEGATIONS OF HARASSMENT AND RELATED INAPPROPRIATE CONDUCT, AND IT'S NOT THAT THEY HAVE NOT ALWAYS BEEN AVAILABLE TO DO SO, BUT HAVE IN THE PAST, I THINK, HAVE BEEN FOCUSED A BIT MORE ON THE SORT OF WORKPLACE HARASSMENT OF ACTION AND ACTIVITIES, AND AS A RESULT, BECAUSE THAT WAS THE ONLY TYPE OF ACTIVITY THAT PEOPLE MIGHT HEAR ABOUT, AND ADMINISTRATIVELY KIDS WHO ARE BEING -- INDIVIDUALS WHO HAVE BEEN SUCKBJECTED TO OR OBSERVED SEXUAL HARASSMENT DIDN'T KNOW IF THAT WAS THE PLACE TO GO AS ONE OPPORTUNITY TO AIR THEIR CONCERNS OR THEY WILL LOATHE TO GO THERE BECAUSE THOSE ADMINISTRATORS WILL DO WHO KNOWS WHAT THE CONCERN WAS AND SO THIS HAS BEEN RECAST IN A VERY DIFFERENT WAY. SO THAT IT IS ABSOLUTELY CLEAR THAT THIS OFFICE IS PREPARED, EQUIPPED AND QUALIFIED TO DO INTAKE OF THESE TYPES OF ISSUES AND I'LL ELABORATE ON THIS IN A BIT. AND WE -- WE HAVE EXPANDED THE CIVIL ADVISORY COMMITTEE TO INCLUDE MEMBERS OF THIS ANTIHARASSMENT STEERING COMMITTEE TO UNDERSCORE THE COMMITMENT TO EXPAND OUT THE PURVIEW, IF YOU WILL, OF THIS GROUP. AND THEN, OF COURSE, THERE ARE A WHOLE SERIES OF TOOLS THAT ARE NEEDED, AND SOME OF THESE TOOLS ALREADY EXISTED, BUT WE WANTED TO ENHANCE THEM, TO MAKE THEM MORE USEFUL, MORE USER-FRIENDLY, AND IN PARTICULAR, ONE OF THE THINGS THAT CAME UP OVER AND OVER AGAIN IN DISCUSSION IS THAT WE NEEDED A SYSTEM THAT ALLOWED FOR ANONYMITY. NOW, YOU UNDERSTAND THAT -- IF YOU REMAIN ANONYMOUS, YOU LIMIT THE DEGREES OF FREEDOM FOR ACTION, BUT THERE ARE A SUBSET OF PEOPLE FOR WHOM MAINTAINING ANONYMITY IS ABSOLUTELY CRUCIAL. AND WE FELT THAT WE WERE MISSING INFORMATION BY NOT OFFERING THAT AS AN OPTION, SO THIS SYSTEM NOW ALLOWS FOR BOTH ANONYMOUS AND NON-ANONYMOUS REPORTS AND ALSO INCREASING THE WEB PRESENCE OF THIS SPANNING MANY SITES DIFFERENT OFFICES WHERE INDIVIDUALS WOULD CONTINUE TO TYPICALLY GO BUT NOW HARMONIZING AND TRYING TO INTEGRATE WHAT THEY ARE EACH DOING, AND SO THE OFFICE OF HUMAN RESOURCES RESOURCES -- THE -- OFFICE OF EQUITY AND DIVERSITY AND INCLUSION -- THIS IS THE TRAINING OFFICE WITHIN THE INTRAMURAL PROGRAM WHERE ALL THE POST DOCS AND POST-BACKS TEND TO BE SUPPORTED. THE OMSBUDS OFFICE AND THE HANNAH VALENTINE OFFICE OF SCIENTIFIC WORKFORCE DIVERSITY, SO ALL OF THESE GROUPS HAVE EQUITIES IN THIS SPACE AND IT'S NOT THAT WE'RE NOT TALKING TO ONE ANOTHER BECAUSE, OF COURSE, THEY ARE THAT BUT WE'RE MAKING IT MORE FORMAL. WE'RE MAKING IT EASIER. WE'RE USING MORE COMMON LEXICONS AND TOOLS. AND THEN THERE'S THE ACTUAL PROCESS TO INCLUDE THE REPORT AND I'LL ELABORATE ON THAT AND, OF COURSE, WE ARE WORKING ON POLICIES TO PREVENT AND ADDRESS HARASSMENT AND INAPPROPRIATE CONDUCT AND WE'RE CREATING WHAT WE CALL IN THE GOVERNMENT A MANUAL OF CHAPTER WHICH IS THE BIBLE OF REGULATIONS WHICH WE LIVE BY. THIS IS A PROCESS THAT TAKES SOME TIME TO BOTH CRAFT AND HAVE VETTED AND SO FORTH AND WE ARE GOING TO THAT AND WE'VE ALSO CRAFTED A POLICY STATEMENT WHICH WE CAN ELABORATE ON IF -- IF FOLKS ARE INTERESTED. SO IN TERMS OF REPORTING TOOLS, THE FULL LAUNCH WILL BE IN AUGUST. WE HAVE ESTABLISHED A 1-800-NUMBER. THERE'S AN OPTION TO REMAIN ANONYMOUS, WHICH AGAIN, PEOPLE FELT WAS VERY IMPORTANT. WE ARE WORKING WITH AN EXISTING HOTLINE, IF YOU WILL, IN PATIENT SAFETY, WITHIN THE CLINICAL CENTER SO WE CAN DO SOME CROSS-TRAINING TO ULTIMATELY ENSURE BACKUP AND THIS WEB PRESENCE AGAIN, WE'RE DEVELOPING AN ONLINE WEB FORUM FOR REPORTING ALLEGATIONS. SOME PEOPLE ARE JUST MORE COMFORTABLE DOING IT VIA THE WEB AS OPPOSED TO PICKING UP A PHONE, BUT -- AND SO WE NEED BOTH TYPES OF THINGS. AND WE ARE UPDATING THE CIVIL WEB PAGE WITH THESE PROCESSES AND NEXT STEP INFORMATION. > THE ANTICIPATED COMPLETION OF THE SO-CALLED MANUAL CHAPTER WHICH IS OUR INTERNAL GOVERNANCE, OUR INTERNAL REG, WE ANTICIPATE TO COMPLETE THIS IN 2018. THIS NEEDS TO BE REVIEWED BY MULTIPLE LAYERS WITHIN -- NOT ONLY THE AGENCY BUT BEYOND, WITHIN THE DEPARTMENT. SIMILARLY, WE HAVE -- WE HAVE DRAFTED A POLICY STATEMENT RELATED TO PERSONAL RELATIONSHIPS IN THE WORKPLACE. AND, OF COURSE, AS YOU MIGHT IMAGINE, THESE ARE -- THESE ARE RELATIONSHIPS IN WHICH THERE IS A POWER GRADIENT. THAT'S WHAT WE'RE PARTICULARLY CONCERNED ABOUT. AND I KNOW THAT YOU WILL ALL -- YOU'RE AT LEAST THINKING, WOW, THERE ARE A LOT OF GRAY AREAS, YES, THERE ARE BUT THERE ARE MANY THAT ARE NOT AND EVEN THOUGH CURRENT TEMPERATURE BE A GRAY AREA, WE STILL HAVE BE ABLE TO RESOLVE WHAT IS A POTENTIAL CONFLICT. THE GOAL, OF COURSE -- THE GOAL, OF COURSE, IS TO DEVELOP A WORKPLACE THAT CREATES THE ENVIRONMENT THAT IS FREE FROM RELATIONSHIPS THAT CAUSE A REAL OR PERCEIVED CONFLICT OF INTEREST. THAT'S SIMPLE TO SAY BUT IT'S COMPLICATED. HARASSMENT ALLEGATION GUESS PREVIOUSLY, INSTITUTES AND CENTERS WOULD WORK WITH EMPLOYEE RELATIONS AND CIVIL STAFF TO REVIEW AND RESOLVE CONCERNS IN THE HOUSE. THERE WERE CONCERNS EXPRESSED ABOUT THAT APPROACH AND NOW ALL ALLEGATIONS OF THIS TYPE ARE REPORTED TO CIVIL FOR A CENTRALIZED MANAGEMENT AND OVERSIGHT. THE KEY POINT IS THAT INSTITUTES AND CENTERS ARE NOT PERMITTED UNDER ANY CIRCUMSTANCES TO REVIEW AND INVESTIGATE THEMSELVES. THEY PARTNER -- THEY PROVIDE US WITH INFORMATION, BUT NOW A THIRD-PARTY NEEDS TO LOOK AT THIS TO PROVIDE CONSISTENCY. WELL, THE TIMELINE IS LISTED HERE. AND VERY IMPORTANTLY, IN THE FALL WE ARE AIMING TO RELEASE A WORKPLACE CLIMATE AND HARASSMENT SURVEY, ONE THAT ANA VALENTINE AND HER COLLEAGUES HAVE BEEN WORKING VERY HARD AT, WITH THE GOALS OUTLINED HERE AND IT WILL BE ADMINISTERED TO ALL NIH/FTE CONTRACTORS FELLOWS AND STUDENTS. SO IT WILL BE A VERY BROAD WORKPLACE CLIMATE AND HARASSMENT SURVEY. WILL ASK SOME OF THESE IMPORTANT QUESTIONS, THE IMPACT ON CAREER CHOICE AND WHETHER -- AND TO WHAT EXTENT SEXUAL HARASSMENT HAS FLUID -- IT WILL BE USING A SCIENTIFIC APPROACH. THERE'S VERY NEW VALIDATED INSTRUMENTS THAT HAVE BEEN SCIENTIFICALLY TESTED AND VALIDATED AND THAT IS WHAT THE END GOAL HERE AND HANNAH AND HER COLLEAGUES ARE WORKING THROUGH THIS SO THE PHASES ARE LISTED HERE. WE ARE CERTAINLY WELL INTO PHASE 1 AND LOOK FORWARD TO COMING BACK TO YOU ONCE WE HAVE ANALYSIS OF DATA. SO WITH THAT I WILL STOP AND TURN IT BACK TO FRANCIS TO GO THROUGH THE DISCUSSION. >> THANK YOU, LARRY, AND THANKS TO ALL OF THOSE WHO WORKED TOWARD ON GETTING US TO THIS POINT STILL WITH MUCH, OBVIOUSLY, WORK TO DO BUT AT LEAST WE HAVE A PRETTY FIRM FRAMEWORK. I'LL BE VERY GLAD TO HEAR COMMENTS FROM THE ACD. >> I HAVE A DIFFICULT POINT AND THEN A QUESTION. I JUST FIND IT -- A PERSONAL THING. I JUST FIND IT A LITTLE DISAPPOINTING THAT THE IMPLEMENTATION THAT'S BEING OFFERED AND MAYBE IN WHAT WAS REFLECTED HERE THIS IS AN INITIALLY ADDRESSED BECAUSE IT HAS AN IMPACT ON THE PRODUCTIVITY OR THE WORKFORCE OR THE IMPACT ON THE CONDUCT OF SCIENCE. IT REMINDS ME -- I HAD A REQUEST TO MAKE FROM THE CHAIR OF MY DEPARTMENT AT HOME AND I MADE ALL MY POINTS AND MY ARGUMENTS. IT WAS A FINANCIAL ASK, AND AFTER I FINISHED WHAT I THOUGHT WAS A VERY SMART ARGUMENTATION. SHE SAID WELL, SHE JUST COMPLETELY REMOVED FRIDAY IMPLEMENTATION BUT SHE SAID WE'RE GOING TO DO THIS BECAUSE IT IS THE RIGHT THING TO DO, BECAUSE IT IS THE RIGHT THING TO DO. I'M A LITTLE DISAPPOINTED. THAT IT SHOULDN'T BE AN ENTIRE ARGUMENTION. THERE'S A RIGHT AND A WRONG. MAYBE I'M JUST TRADITIONAL AND THERE'S A RIGHT OR A WRONG AND THE FIRST POINT THIS IS NOT TO BE TOLERATED BECAUSE IT IS JUST NOT RIGHT. >> I MEAN, AND AGAIN, I OF COURSE, I AGREE WITH YOU AND IT IS A GIVEN BUT MAYBE WE NEED TO DO A BETTER JOB TO SAY IT OUT LOUD. >> AND THEN THE QUESTION I WAS VERY SHOCKED FOR THE STATISTICS OF THE MEDICAL STUDENTS COMPARED TO THE GRADUATE STUDENTS WHO ARE THE SAME AGE AND SAME LEVEL OF PROFESSIONAL ACCOMPLISHMENT AND I WONDER IF THERE'S ANY GRANULARITY ON THE TIME IN WHICH THE SEXUAL HARASSMENT INCIDENTS TOOK PLACE BECAUSE I WONDER WHETHER THE TOXIC ENVIRONMENT MIGHT BE THIRD-YEAR HOSPITAL -- I WORK IN AN ENVIRONMENT AT NIGHT, VERY STRESSED, VERY HIERARCHICAL. >> THAT'S WHAT BOTH HANNAH AND MIKE AND FRANCIS HAVE SHARED, O.R.s AND, YOU KNOW -- >> CALL ROOMS. YOU'VE BEEN THERE. >> SO, YEAH, I MEAN, AGAIN -- AND I -- AND I'M BORING YOU. SO IT'S -- IT'S JUST, YOU KNOW, IT'S THE NAME OF THE HIERARCHY AND HIERARCHIES HARD-WIRE THE POWER GRADIENT AND ONCE YOU GOT A POWER--GRADABLE. >> IT'S HIERARCHY, THERE'S LONG HOURS, HIGHLY STRESSFUL RELATIONSHIPS AND THERE'S RELATIONSHIPS UNDER STRAIN BECAUSE OF YEARS OF TRAINING, THERE'S A NUMBER OF THINGS THAT ALL COALESCE INTO A TOXIC ENVIRONMENT. >> MARK? >> FIRST, YOU KNOW, JUST TO AGREE WITH JOSE'S POINT WHICH I DIDN'T HEAR YOU SAYING -- THERE'S ALSO AN IMPLICATION TO WHAT'S RIGHT WHICH IS, YOU KNOW, IMPACTS THE INTERACTION THAT IS NECESSARY FOR SCIENCE. SO I THINK THERE'S A WAY TO SAY BOTH BUT WE DEFINITELY SHOULD BE SAYING IT'S RIGHT TO DO THIS AND THAT'S THE ONLY REASON THAT WE NEED. YOU KNOW, THE STATEMENTS THAT YOU PUT OUT ARE GREAT AND THE GUIDANCE BUT I WONDER IF THERE WOULD BE AN OPPORTUNITY HERE JUST TO THINK ABOUT ESPECIALLY IN LIGHTS OF THE NATIONAL ACADEMY REPORT TO SEND A LETTER TO ALL OF THE DEANS VICE PRESIDENTS TO SAY I'M TAKING THIS SERIOUSLY OR AS NIH, WE EXPECT YOU AS OUR GRANTEES TO HAVE THE STRONGEST POSSIBLE POLICIES, AND EVEN ESTABLISH -- AND THAT WE EXPECT TO BE -- HAVE ANY REPORT OF ANY MISCONDUCT BY ANY GRANTEE OF OURS TO BE REPORTED TO US. OR HOWEVER YOU WANT TO FORMULATE THAT, THAT WOULD BE UP TO YOU TO FIGURE OUT. MAYBE COME ON THE SYSTEM BASICALLY 3 STRIKES AND YOU'RE SUSPENDED. IF YOU HAVE 3 GRANTEES OR HOWEVER YOU WANT -- IT'S A SHAME WE HAVE TO BE UTILITARIAN AND WE DON'T SAY IT'S RIGHT AND YOU SHOULD ALL DO IT AND IT GO AWAY. REALLY START MAKING CLEAR AND THAT WILL START LEADING, I THINK, TO SYSTEMATIC CHANGE SO THAT YOU'RE REALLY PUSHING THE ISSUE FORWARD AS MUCH YOU CAN. >> I'D LOVE TO HEAR ROY'S VIEW ON THAT REPRESENTING THOSE ACADEMIC INSTITUTIONS WHO LOVE TO GET LETTERS FROM US. >> WELL, I WILL MENTION MY VIEW ON THAT IN A SECOND. BUT LIVING IN MICHIGAN WE HAVE DEALT WITH THESE ISSUES A LITTLE BIT MORE THAN OTHER PEOPLE, I THINK. A COUPLE THOUGHTS: ONE IS THAT PARTICULARLY WITH THE NATIONAL ACADEMY OF SCIENCE ARTICLE, THERE'S ALREADY TALK OF THIS IN THE ACADEMIC COMMUNITY WHO ARE -- SPEAKING OF RIGOR, WHO ARE TALKING ABOUT THE LACK OF RIGOR IN THAT STUDY, AND LACK OF RIGOR IN THE TEXAS STUDY. AND, YOU KNOW, THERE ARE TIMES WHEN RIGOR IS VERY IMPORTANT AND THERE ARE TIMES WHEN IT'S SECONDARY. AND -- AND THIS IS ONE OF THE TIMES WHERE IT'S SECONDARY, AND WHETHER, YOU KNOW, THE ACTUAL PERCENTAGE IS 50% OR 20% DOESN'T MAKE A DIFFERENCE. IT'S WAY TOO HIGH, AND FOR THE ACADEMIC COMMUNITY TO TRY TO TALK ABOUT THE RIGOR OF THESE STUDIES I THINK IS ABSOLUTELY THE WRONG -- THE WRONG THING TO DO, AND I THINK THAT'S SOMETHING THAT IS JUST A REFLEX AMONGST SOME MEMBERS OF THE ACADEMIC -- YOU KNOW, WAS TRAINED THAT WAY TO LOOK AT RIGOR. THE SECOND THOUGHT I HAD AGAIN, LIVING IN MICHIGAN, WE'VE HAD TO INSTITUTE POLICIES -- IT WAS PRETTY MUCH IMPOSED UPON US BY THE LEGISLATURE TOWARDS SOME OF THE THINGS THAT YOU'RE DOING. AND THE ONLY CAUTION I WOULD HAVE IS THAT -- FIRST OF ALL, IT'S BEEN GREAT. IT'S BEEN -- THERE'S BEEN A LOT OF REPORTS I THINK AN ANONYMOUS NATURE, I THINK, IS VERY IMPORTANT. BUT WE'VE ALSO GOTTEN A LOT OF I WON'T CALL THEM RIV IS THERE ANYTHING ELSE BUT NONSTIMULUS PLAN -- RIVET GUESS BUT I WON'T CALL THEM NONSUBSTANTIVE COMPLAINTS ESPECIALLY WITH SOCIAL MEDIA AND WHEN SOMETHING GETS OUT AND IT GETS ALL OVER THE PLACE AND SO THAT'S -- THAT'S SOMETHIN TO FIGURE OUT HOW WE'RE GOING TO DO A BETTER JOB OF -- >> SO, ROY, THAT'S A POINT THAT OUR COMMITTEE HAS DISCUSSED, AND PEOPLE ACKNOWLEDGE THAT, YOU KNOW, ALLEGATIONS OF THIS NATURE CAN BE VERY SERIOUS, AND IF -- AND IF INCORRECT OR IF THEY'RE, YOU KNOW, ADVOCATED, YOU COULD HAVE VERY SERIOUS CONSEQUENCES. BUT THAT'S WHY THERE WAS THIS REAL -- WITH SOME UNINIMITY, A DESIRE TO HAVE A THIRD-PARTY EXAMINATION OF THE FACTS SURROUNDING WHAT ARE THE ALLEGATION OR SITUATION IS. SO ON ONE EXTREME YOU DON'T WANT SOMEBODY SWEEPING IT UNDER THE RUG SO TO SPEAK BUT ON THE OTHER EXTREME, YOU WANT TO MAKE SURE THAT A FAIR AND, YOU KNOW, UNIFORMED TO THE EXTENT THAT IT'S POSSIBLE, YOU KNOW, EXAMINATION IS PROVIDED TO THE VARIOUS SITUATIONS. >> YOU JUST HAVE TO DO THE BEST THAT YOU CAN DO AND EXPECT YOU'RE GOING TO GET A CERTAIN PERCENTAGE AND SO ON. >> I ACTUALLY WILL UNDERSCORE ROY'S POINT. WE HAVE DIFFERENT VIEWS ABOUT THE BALANCE BETWEEN, YOU KNOW, WHAT IS A SERIOUS OFFENSE AND THE NATURE OF HOW STUDENTS ARE PERCEIVING IT TO THE POINT THAT SOME OF US HAVE STARTED PLANNING STUDENTS BECAUSE WE THINK WITH THEY'RE STARTING TO SEE THEMSELVES AS VICTIMS IN A LOT OF PLACES WHE WHERE -- THEY'RE -- I'VE BEEN SEXUALLY HARASSED AND -- BY BRIGHT, CLEAR -- YOU WOULD NOT -- NO ONE IN THIS ROOM WOULD ARGUE IT WAS HARASSMENT AND I WOULD ARGUE IT'S ANNOYANCE, AND THE ANNOYANCE IS YOU JUST DEAL WITH IT AND THERE'S BEEN IN SOME CASES A SHIFT TO WHAT USED TO BE AN ANNOYANCE THAT YOU COULD DEAL WITH IS NOW BEING PERCEIVED AS HARASSMENT. AND AGAIN, EVERYBODY HAS DIFFERENT VIEWS BUT IT'S TO THE POINT OF THE PENDUM SWINGING FAR ENOUGH ABOUT HOW -- HOW YOU REALLY DEFINE THINGS THAT IT'S WORTH -- WE'RE STARTING TO HAVE SOME DISCUSSIONS WITH OUR POST-DOC STUDENTS WHERE IS THE LINE. >> SO I GUESS BEFORE READING THE ACADEMY REPORT, I WOULD HAVE NOT AND SAID, YEP, I GET IT. BUT AFTER READING IT, MY CONCERN IS, IS THE CUMULATIVE EFFECT OF ANNOYANCES, PLURAL. YOU KNOW, NOT A ONE-OFF BUT MULTIPLE ANNOYANCES OVER -- YOU KNOW, AS A FUNCTION OF TIME. DOES THAT CONTRIBUTE -- COULD THAT BE CONTRIBUTING TO AN ENVIRONMENT WHICH MAKES MORE EGREGIOUS CIRCUMSTANCES MORE LIKEL LIKELY? >> I'M REALLY THINKING ABOUT IT AND -- IF YOU RANK IN PRIORITY AND YOU DEFINE THESE AS A FACULTY MEMBER IN MY LIFE -- NO, I THINK IT'S A FAIR QUESTION AND IF I HAD A GUN AGAINST MY HEAD AND HAD TO PREDICT, I -- I STILL SAY WE SHOULD LOOK HARD AT WHETHER THAT HYPOTHESIS IS REALLY TOTALLY OUT THERE IN PRIORITIES FOR WHAT MAKES IT HARD FOR WOMEN. >> A COMMENT ABOUT GENDER HARASSMENT, I THINK WHAT YOU MIGHT BE REFERRING TO, LINDA, IN TERMS OF THE ANNOYANCES IS WHAT IS DEFINED AS GENDER AND HARASSMENT. AND I -- WHAT THIS -- WHAT THIS SURVEY OF THIS REPORT HIGHLIGHTS IS THAT IT IS EXACTLY THOSE THINGS THAT ARE THE HARBINGER OF THE MORE EGREGIOUS FORMS, AND NOT ONLY HARBINGER OF EGREGIOUS POINTS, TO JOSE'S POINT, THEY ALSO HAVE CONSEQUENCES, THEY HAVE CONSEQUENCES IN SYSTEMS FOR PEOPLE TO LEAVE AND SOME HAVE PERHAPS SIGNIFICANT ECONOMIC CONSEQUENCES. SO THOSE -- I THINK ONE OF THE MOST ENLIGHTENED THINGS ABOUT THIS REPORT IN TRYING TO READ IT IS MAKING THE LINK THAT GENDER HARASSMENT, MEANING THOSE ANNOYANCE WORDS YOU HEAR PEOPLE SAY WELL, THIS IS NOT THE RIGHT ENVIRONMENT FOR A WOMAN TO WORK IN, THOSE ARE THE VERY THINGS THAT THEY NEED, AND TO YOUR POINTS THE SCIENCE BEHIND CAUSE ALITY WHICH IS NOT AT THE LEVEL WE EXPECT AND THAT IS WHAT SUBSEQUENT SURVEYS ATTEMPT TO DO. >> LET ME JUST RESPONSIBILITY BECAUSE WE HAD MAYBE -- I MISCOMMUNICATED. WHAT HAS RAISED A RED FLAG WITH MY FEMALE COLLEAGUES AND I WHERE THERE CAN JUST BE COMMENTS MADE THAT ARE NOT SPECIFICALLY GENDER HARASSMENT. THEY'RE JUSTDOWN, YOU KNOW -- JUST TYPICAL, YOU KNOW, MY WOMEN FRIENDS AND I WOULD MAKE TO EACH OTHER BUT SOME GRADUATE STUDENTS HAVE GOTTEN SO SENSITIVE, THEY WILL TAKE SOMETHING THAT REALLY IS -- IT'S NOT AT ALL GENDER-SPECIFIC. IT WILL BE SOMETHING IN THE CONTEXT OF WORK AND THEY'LL INTERPRET IT AS, OH, THEY ONLY SAID THAT BECAUSE I'M A WOMAN. WHEN -- AND SO IT'S JUST A MATTER -- IT'S NOT SPECIFICALLY A GENDER-SPECIFIC BUT IT'S JUST -- JUST ANY KIND OF COMMENT THAT'S MAYBE NOT -- IT WOULD BE TAKEN OUT OF CONTEXT AND THAT'S WHAT WE'RE CONCERNED ABOUT. THAT -- >> SO THIS CALL FOR SOCIAL SCIENCE RESEARCH TO UNPACK WHAT YOU'RE TALKING ABOUT BUT THERE'S AN ONGOING HYPOTHESIS THAT EVEN THOSE THINGS THAT WE HAVE BECOME USED TO THINKING OF CREATES THIS ENVIRONMENT IN WHICH SEXUAL HARASSMENT BREATHES, LIVES AND ULTIMATELY MANIFESTS ITSELF TO THE OTHERS. [SPEAKER AWAY FROM THE MIC] >> I CAN GIVE YOU SPECIFIC EXAMPLES THAT WOULD BACK UP WITH LINDA IS SAYING BUT I DON'T WANT TO DEBATE THAT. I WAS ASKED TO COMMENT ON MARK'S SUGGESTION. THE FIRST PART WHERE I THOUGHT WHERE HE WAS GOING I FELT A LITTLE CRINGE WHICH WAS, YOU KNOW, I DON'T THINK RESEARCH WOULD APPRECIATE A -- A NOTE FROM NIH SAYING, YOU KNOW, YOU GOT TO LOOK AT YOUR SEXUAL HARASSMENT POLICIES AND THINGS LIKE THAT, BUT -- SO THAT'S NUMBER 1. HOWEVER THE SECOND POINT THAT HE SAID WHICH WAS VERY SPECIFIC WOULD PROBABLY BE FINE AND, IN FACT, I WOULD COURAGE BECAUSE I DIDN'T KNOW FOR SURE THAT IF THERE WAS SOME SITUATION ON MY CAMPUS RELATED TO SEXUAL HARASSMENT AND IT WAS AN INVESTIGATOR -- AND I WAS AN INVESTIGATOR AND I WOULD HAVE TO REPORT THAT TO NIH. SO THAT'S GOOD INFORMATION TO HAVE AND SO SOME VERY SPECIFIC THINGS, LIKE, THAT -- LIKE THAT I THINK I WOULD APPRECIATE AND I THINK OTHERS WOULD TOO. >> ONE -- ONE THOUGHT ON THE -- LINDA, ON YOUR POINT LIKE ARE THERE DEGREES AND WHAT ARE THE CONSEQUENCES OF -- IT SEEMS INOCNOCUOUS AND IT MAY NOT -- BUT AT LEAST INCLUDING IN THE CONVERSATION THAT THERE ARE DEGREES, I THINK, IS IMPORTANT, BECAUSE I THINK -- AND THEY MIGHT BE BAD, WORSE, AND REALLY BAD, RIGHT? I'M NOT SAYING THERE'S AN OKAY ON THIS CONTINUUM, BUT I THINK RECOGNIZING THAT ALLOWS THE CONVERSATION TO REACH A LOT MORE PEOPLE. YOU TALKED ABOUT WHY IS THERE THIS REFLEXIVE PUSH-BACK AND LET ME QUESTION THE RIGOR AND ON THE PERCEPTION THERE'S A BROAD BRUSH OF PERCEPTION OF ALL THINGS -- FROM THE THINGS THAT NEED HYPOTHESIS TESTING TO THE THINGS THAT ARE FLAT-OUT ILLEGAL TO PAINT THEM THE SAME WAY. THE EASIER IT IS FOR PEOPLE -- FOR PEOPLE JUST TO REJECT THE ENTIRE ENDEAVOR. AND I THINK BY COMING AT IT WITH A MORE RECOGNITION THAT THERE'S COMPLEXITY AND THAT THERE'S A CONTINUUM WHERE NOBODY WILL DISAGREE AND, YOU KNOW, BAD, WORSE, WORST. SEARS WOULD NOT LIKE THAT MARKETING TAKE, RIGHT? BUT I THINK IT WOULD ALLOW A BETTER CONVERSATION. I THINK THAT WILL MOVE THINGS -- WILL LET THE REACTIONS BE BETTER. AND THEN ONE SMALL OPERATIONAL POINT ON SOME OF THE GREAT PROCESSES YOU'VE PUT OUT. HAVE YOU CONSIDERED OR REALLY I'D SUGGEST YOU'D CONSIDER HOW MUCH TRANSPARENCY YOU WANT TO INCLUDE IN REPORTING BROADLY PUBLICLY IF POSSIBLE THINGS LIKE IN 2017, WE HAD THIS MANY ALLEGATIONS. WE INVESTIGATED AND SUBSTANTIATED THIS NUMBER. AND WE TOOK -- YOU KNOW, HOW MUCH IS THAT PART OF THE PLAN? >> IT'S PART OF THE PLAN, OBVIOUSLY, AGGREGATE DATA BUT, YES, IN FACT, AT EVERY MEETING THAT WE HAVE, WE HAVE A MONTH -- I GUESS IT'S LIKE A MONTHLY SNAPSHOT WHERE THINGS ARE SO FAR AND WE WILL MAKE THAT AVAILABLE BROADLY, YOU KNOW, I GUESS EVERYBODY YEAR, I GUESS, QUARTER? >> AND JUST GOOD BECAUSE FOR SEVERAL REASONS. ONE OF WHICH IT WILL -- IT WILL HELP THE INTERNAL POPULATION UNDERSTAND BOTH THAT YOU TAKE IT SERIOUSLY AND THAT YOU DON'T TAKE IT -- YOU DON'T ACCEPT THINGS BLINDLY, RIGHT? BECAUSE THE RESULTS WILL SHOW THAT YOU ACTED ON SOME PERCENTAGE AND YOU DISMISSED SOME OTHER PERCENTAGE AND BOTH OF THOSE ARE IMPORTANT FOR PEOPLE TO KNOW HAPPENED. >> THAT'S PRECISELY, YOU KNOW, THE DIRECTION THAT WE WANT TO TAKE. >> JUST A CLARIFICATION. YOU CALL IT THE ANTIHARASSMENT STEERING COMMITTEE. IS IT EXCLUSIVELY SEXUAL HARASSMENT OR IS IT A HOSTILE ENVIRONMENT, AND IS IT PART OF THE TROUBLE WE'RE ALL HAVING, YOU KNOW, WHERE DOES HOSTILE ENVIRONMENT -- YOU KNOW, BECOME SEXUAL -- >> WE HAVE -- WE HAVE CONSIDERED ALL FORMS OF HARASSMENT, CIVIL. THIS ORGANIZATION DEALS WITH ALL 4 FORMS, BUT BECAUSE OF THE PARTICULARLY COMPLICATED ISSUES SURROUNDING SEXUAL HARASSMENT, WE HAVE FOCUSED MUCH OF OUR ATTENTION AS A COMMITTEE ON THAT, BUT THE TOOLS THAT ARE BEING DEVELOPED CAN, IN FACT, BE EMPLOYED FOR OTHER FORMS OF OTHER FORMS OF HARASSMENT. >> SO I SUPPOSE IN MY MIND WHERE BULLYING -- >> YES. >> SO -- >> YES. >> SO THIS PROBLEM -- >> SO BULLYING CAN OR CANNOT BE SEXUAL IN NATURE, AND WE ARE -- WE ARE WORKING THROUGH THAT, AND THAT CAN BE COMPLICATED. >> I THINK RELATED TO THAT -- AND WHERE IT'S VERY DIFFICULT TO FIND SORT OF ACTIONABLE THINGS IS THIS -- THIS NOTION WHICH WE'RE TALKING AROUND A LITTLE BIT BECAUSE IT'S HARD TO -- IT'S HARD TO TALK ABOUT AN ABSTRACT, RIGHT? IT'S THESE EXAMPLES IN WHICH, YOU KNOW, THERE'S SORT OF THE OPEN SECRET WHEN PROFESSIONAL WOMEN GET TOGETHER AND SORT OF DISSECT WHAT HAS HAPPENED IN A PROFESSIONAL SETTING AMONG COLLEAGUES OF DIFFERENT GENDERS THAT THE CONVERSATION GETS INTO SOME OF THESE ANNOYANCES, TO USE YOUR TERM, BUT THIS VERY CLEAR SENSE THAT THERE ARE BEHAVIORS PRACTICED BY MALE COLLEAGUES THAT ARE DIFFICULT TO PUT YOUR FINGER ON AT THE TIME BUT WHEN YOU LOOK AT THEM, YOU SEE THE SO FAR CULTURAL PATTERN OF BEHAVIOR THAT'S -- THAT IS DIFFICULT TO SORT OF PINPOINT AN ACTIONABLE WAYS AND I THINK THAT NATIONAL ACADEMY'S REPORT DOES GET TO THIS SORT OF CONNECTION BETWEEN THOSE THINGS WHICH I THINK ARE -- I WOULD SAY OPEN SECRETS. I THINK YOU'VE SEEN THIS PLAY OUT IN BROADER SOCIETY WHERE PATTERNS OF BEHAVIOR ARE ALLOWED TO CONTINUE FOR A VERY LONG TIME AND EVERYBODY KNOWS ABOUT THEM, RIGHT AND YET NOBODY IS SORT OF TAKING THEM HEAD ON, AND I THINK THERE ARE THINGS THAT MOVE OVER INTO THIS EGREGIOUS ACTUAL BEHAVIOR, ACTIONABLE BEHAVIOR IN THE SEXUAL HARASSMENT AND SEXUAL ASSAULT SPACE BUT THEN THERE IS THIS FAR MORE SORT OF DIFFICULT CULTURAL SORT OF ISSUES IN THE GENDER HARASSMENT'S ARENA THAT ARE MUCH MORE DIFFICULT TO TACKLE IN LARGE PART BECAUSE WE DON'T REALLY TALK ABOUT THEM IN VERY CLEAR WAYS AND PARTICULARLY IN MIXED GENDER GROUPS AND SO THAT IS SOMETHING THAT I THINK THAT'S -- I'M NOT SURE I HAVE A READY SOLUTION FOR IT BUT WE MAYBE NEED TO THINK ABOUT HOW DO WE HAVE THE CONVERSATION IN A WAY THAT DOESN'T SORT OF CIRCLE AROUND ISSUES THAT ARE PROBABLY REAL AND CONTRIBUTORY TO GREATER PROBLEMS. >> YOU KNOW, WE CARRY IN THIS STEERING COMMITTEE THAT WE'RE IVOLVED WITH, IT IS A MIXED GENDER GROUP. AND I THINK THE CONVERSATIONS NOW ARE MUCH MORE OPEN THAN THEY ARE THAT AT THE VERY BEGINNING PERHAPS. IT'S TAKEN A LITTLE TIME FOR PEOPLE TO GET MORE COMFORTABLE AND SO FORTH. I THINK THE WAY THIS MANIFESTS IS IN A NEW SERIES OF TRAINING MATERIALS THAT NEED TO BE DEVELOPED BECAUSE PART OF THIS IS, YOU KNOW, WE'VE GOT TO -- WE'VE GOT TO TALK ABOUT THIS OPENLY, YOU KNOW, AS YOU -- AS YOU SUGGESTED -- AND MAYBE VIGNETTES AND WAYS OF ALLOWING PEOPLE TO -- TO GIVE THEM THE SORT OF SUBSTRATE TO ALLOW FOR THE DISCUSSION TO HAPPEN. BUT IT'S HARD SOMETIMES. >> WELL, THANK YOU, EVERYBODY. A DIFFICULT TOPIC BUT A VERY CRITICAL ONE AND I BET WE'LL BE TALKING ABOUT THIS AGAIN AS THIS PLAYS OUT. THANKS TO ALL THOSE WHO HAVE BEEN LEADING THIS EFFORT DIFFICULT AS IT IS BECAUSE WE NEED TO FIGURE OUT A PATH FORWARD THAT'S DIFFERENT THAN WHERE WE'VE BEEN. BECAUSE LARRY DOESN'T HAVE ENOUGH TO DO WE'RE ALSO GOING TO HEAR FROM HIM ABOUT ANOTHER TOPIC WHICH IS BEING COLED BY HIM AND -- CO-LED AND BRENDON LEE LOOKING AT HIGH RISK AND HIGH REWARD GRANT MECHANISMS. THIS IS A NEW WORKING GROUP. THEIR FIRST MEETING WAS JUST IN APRIL. THEY'RE EVALUATING THESE PROGRAMS IN THE COMMON FUND FOR EFFECTIVENESS AND FOR REPRESENTATION OF WOMEN AND UNDERREPRESENTED MINORITIES, AND LARRY IS GOING TO PRESENT A STATUS REPORT BUT, OBVIOUSLY, THIS IS NOT ONE WHERE YOU'RE READY FOR THE FINAL RECOMMENDATION. >> NO, AND THE REASON WHY YOU'RE STUCK WITH ME YET AGAIN THIS IS JUST THE FRAMING. YOU WILL GET APPREHEND BEON NEXT TIME WHEN -- BRENDON NEXT TIME WHEN THERE'S SOMETHING TO TALK ABOUT. MENTIONED THAT NICOLE GABRIELLE RINNI HELPED WITH THE LAST COMMITTEE AND JES MESSES ERIC WHO IS SITTING NEXT TO HER HAVE HELPED WITH THIS ONE. SO THANK YOU FOR BOTH OF YOU. AND I'M GOING TO SORT OF MOTOR THROUGH THIS, MAYBE TAKING A BIT OF TIME ON CERTAIN KEY THINGS BUT THIS REALLY IS TO FRAME THINGS OUT. WE DO HAVE THE COMMON THEMES IN THE HIGH RISK HIGH REWARD AND AS YOU CAN SEE SOME OF THE UNIQUE ATTRIBUTES ARE LISTED HERE IN PARTICULAR TO ENABLE INVESTIGATORS THAT IS TRANSFORMATIVE OR POTENTIALLY TRANSFORMATIVE WITHOUT PRELIMINARY DATA, AND THE THOUGHT IS THAT WE DO RISK MITIGATION BY CONSIDERING PASSING ACCOMPLISHMENTS AND A GREAT DEAL OF FREEDOM IN THE PAST AWARD TO FOLLOW YOUR DISTIN INSTINCT. THERE'S 4 POINTS TO THE COMMON FUND. THE PIONEER AWARD AND THE NEW INNOVATOR AND THE NIH TRANSFORMATIVE AWARD AND THE SO-CALLED SKIP THE POST-DOC THE EARLY INDEPENDENCE AWARD, AND I GUESS WHAT -- IN PART PRECIPITATED THIS EXERCISE, THIS WORKING GROUP WERE THE RESULTS OF THE FY '17 PIONEER AWARD COMPETITION WHERE ONLY ONE OF THE 12 AWARDEES WAS A WOMAN, AND SO IMMEDIATELY FRANCIS AND HIS SENIOR STAFF STARTED WORKING ON THE QUESTIONS WHAT NEEDED TO BE ADDRESSED. WHAT CONTRIBUTED TO THIS OUTCOME AND HOW DO WE APPROACH GENDER DIVERSITY AND IS THIS AN OUTLIER OR WHAT ABOUT OTHER PROGRAMS AND SO A NEW WORKING GROUP WAS BORN. SO HERE IT IS AND AGAIN, I'VE GOT THIS -- I'M ON THIS NEW KICK BECAUSE OF ALL THE GREAT WORK THAT THE NEXT GENERATION GROUP IS DOING WHERE WE HAVE PEOPLE FROM ALL STAGES OF THE CAREER PATH INCLUDING GRADUATE STUDENTS. SO NICOLE IS OUR GRADUATE STUDENT YOU AND POST-DOC, AND AMY IS OUR POST-DOC AND THEN THERE'S A BUNCH OF GRAY HAIRED PEOPLE ALSO BUT EVERYTHING IN BETWEEN AND BRENDON HAS GRACIOUSLY AGREED TO COCHAIR THIS WITH ME. SO THE CHARGE IS OUTLINED AND I WON'T BELABOR IT BUT YOU CAN CERTAINLY READ IT BUT PARTICULARLY OF INTEREST, YOU KNOW, WHAT CAN WE DO TO ENHANCE THE DIVERSITY OF APPLICANTS AND AWARDEES IN THESE H.R.H.R. PROGRAMS. I MEAN, THAT'S SORT OF THE BOTTOM LINE, AND SO ALL 4 OF THE COMMON FUND PROGRAMS WILL BE EVALUATED. WE HAVE BEEN WORKING THROUGH POTENTIAL METRICS THAT WE CAN USE SO, FOR EXAMPLE, FOR THE SKIP THE POST DOC AWARD, SUCCESS MAY BE MEASURED BY THE AWARDEES AND POSITION WHETHER TO MAINTAIN A TENURE TRACK POSITION, ET CETERA, AND THEN THERE ARE SOME NATURAL CONTROL GROUPS THAT -- THAT ONE COULD USE. THERE HAS BEEN A FORMAL REVIEW OF THE PIONEER REWARD YOU SEE AND I WOULD JUST DRAW YOUR ATTENTION TO THIS REPORT WHICH IS ON THE COMMON FUND WEBSITE AND SORT OF BOTTOM LINE IS THAT THIS SEEMS TO AT LEAST IN TERMS OF THE SCIENTIFIC OUTPUT SEEMS TO BE A STRONG PROGRAM, HAVING MORE IMPACT AND SIMILAR AND RANDOM RO1s AND SORT OF EQUIVALENT TO THE IMPACT OF THE HHMI AWARDEES AND AND SO, YOU KNOW, THIS AT LEAST FROM THAT STANDPOINT IT SEEMS TO BE AN EFFECTIVE PROGRAM. SIMILARLY, THE NEW INNOVATIVEOR AWARD HAS -- INNOVATIVEOR AWARD AND WITHOUT GETTING DO DEEP IN THE DETAILS THIS NEW INNOVATEOR RESEARCH APPEARS TO BE MORE INNOVATIVE THAN THE TYPICAL INVESTIGATIVE RO1 BUT AT LEAST THUS FAR IT DOESN'T SEEM TO SIGNIFICANTLY HAVE ANY MORE POSITIVE OR NEGATIVE IMPACT ON THE CAREER OF THE AWARDEES THAN DID GETTING YOUR FIRST RO1. SO THERE IS -- THERE IS THAT. SO WITH REGARD TO, YOU KNOW, THE PARTICIPATION OF WOMEN AND UNDERRPRESENTED MINORITY GROUPS IN GENERAL, YOU KNOW, WHY IS THIS THE UNDERREPRESENTED. WE KNOW FEWER WOMEN APPLY FOR THESE HIGH RISK HIGH REWARD AWARDS COMPARED TO TRADITIONAL RO1s AND I'M WONDERING IS THERE SOME ADDITIONAL BIAS BEING INTRODUCED DURING THE REVIEW PROCESS SO THE GROUP WILL, OBVIOUSLY, SPEND A FAIR AMOUNT OF THE TIME ON THIS. CLEARLY FEWER WOMEN HAVE BEEN APPLYING AND SOME OF THE THINGS WE HAVE BEEN THINKING ABOUT DOING IS MINIMIZE THE FOA LANGUAGE TO LOOK TO SEE IF THERE'S SOMETHING OFFPUTTING ON THAT LANGUAGE AND ANALYZE OUTREACH EFFORT AND SEE IF THERE'S SOMETHING LIMITING IN OUR OUTREACH. AND I THINK IF WE COULD SOLVE THIS INTAKE PROBLEM IT COULD HELP TO SOME DEGREE. IT'S NOT IT IS TOTAL SOLUTION BUT IT WILL HELP TO SOME DEGREE. AND I APOLOGIZE, HOPEFULLY, YOU CAN SEE IT AT YOUR PLACES BUT IF YOU LOOK THERE'S A SORT OF DISTILLATION PROCESS WITH ALL THE AWARDS, BUT THE ONE GOING IN THE WRONG DIRECTION IS THE EARLY INDEPENDENCE WHERE 40% ARE FEMALE BUT THEN THAT GETS DISTILLED DOWN TO 40% AWARDEES; WHEREAS, THE OTHER PROGRAMS IT'S THE SAME OF THE OTHER PROGRAMS AND EVEN ENHANCED AT THE BACK-END. SO WHY IS THAT THE CASE FOR THIS ONE PARTICULAR PROGRAM? SO ALL OF THE PROGRAMS WE WOULD LIKE TO ENHANCE THE PERCENTAGE OF WOMEN WHO APPLY BUT THIS SORT OF DROPOUT, IF YOU WILL, AS WE GO THROUGH THE PROCESS IS A PARTICULAR ADDITIONAL CONCERN. SO AMONG THE STRATEGIES THAT WE'VE KIND OF, YOU KNOW, THOUGHT ABOUT, BUT AGAIN NEED TO DO A GREAT DEAL MORE WORK BEFORE WE'RE WILLING TO, YOU KNOW, MAKE ANY TENTATIVE RECOMMENDATIONS, YOU KNOW, THERE'S VARIOUS MENTORING PROGRAMS AND DIFFERENT WAYS OF PUBLIC SIGNINGS THESE THINGS AGAIN, TO ENSURE THAT WE REACH OUT TO -- TO WOMEN. AGAIN, THE ISSUE RELATED TO THE REVIEW PROCESS, IS THAT CONTRIBUTING TO OUR PROBLEM? WE THINK IT POTENTIALLY MIGHT BE. AND SO -- AND SO WE ARE THINKING THAT PERHAPS WE COULD EVALUATE THE STARTING POOL WE CAN -- IT'S BEEN SUGGESTED THAT WE MAY LOOK AT A SERIES OF METRICS INCLUDING FUNDING RECEIVED AND SO FORTH BUT ALSO TO LOOK AT -- 'CAUSE MANY OF THESE -- MANY OF THESE REQUIRE LETTERS OF RECOMMENDATION AND -- AND IS THERE SOME DIFFERENT SUBTLE OR, OTHERWISE, IN THE WAY THE LETTERS ARE BEING WRITTEN AND TO USE TEXT MINING TO MAKE THOSE COMPARISONS. WE WANT TO -- WE WANT TO LOOK VERY CLOSELY AT THE REVIEW PROCESS PROCESSES. THE PIONEER REWARD PROCESS AND THE EARLY INDEPENDENCE AWARD PROCESS LOOKS SIMILAR. THE PIONEER EARLY INDEPENDENCE AND NEW INNOVATOR ALL ASKED FOR THESE LETTERS OF RECOMMENDATION AND SO IT COULD POTENTIALLY BE THAT THAT'S PART OF THE PROBLEM. I SHOULD POINT OUT AND I THINK JIM ANDERSON OR BETSY WILDER OR BOTH ARE HERE. BETSY'S HERE, OKAY. THANK YOU. SO THE COMMON FUND IS TO PARTICULAR ABOUT THE PATTERNS HERE THEY DON'T WANT TO NECESSARILY WAIT FOR OUR RECOMMENDATIONS BRENDON AND SO THEY'RE ACTUALLY PROPOSING CHANGES FOR THE FY19 EARLY INDEPENDENCE AWARD. THEY WANT TO ELIMINATE THE INTERVIEW. THEY'RE VERY CONCERNED THAT THAT IS CONTRIBUTING NEGATIVELY TOWARDS THIS BACK-END WHERE THE PERCENTAGE OF WOMEN APPLYING IS QUITE GOOD, 40% AS I RECALL, BUT THERE'S THIS DROP-OFF AND SO THEY'RE GOING TO DO AN EXPERIMENT BY LIMB NATION THE INTERVIEW -- ELIMINATE THE INTERVIEW AND THEN THEY'LL WAIT AND SEE WHAT THE COMMUNITY COMES UP WITH BUT I WANT TO SEE IF EVERYBODY KNOWS THAT. >> DID I REPRESENT THAT ACCURATELY, BETSY? THERE'S SOME OTHER PROCESSES THAT WE COULD LOOK AT THAT MAY INFORM US. SO, FOR EXAMPLE, THERE ARE SOME, FOR EXAMPLE, X02 APPLICATIONS FROM NIS THAT ARE ANONYMIZED IF THAT WOULD INFORM US OR HELPFUL. THERE'S ALL SORTS OF MET RESTRICTIONS TO LOOK AT THE REVIEWERS THAT WE ARE CONSIDERED TO D -- AND FINALLY, YOU KNOW, WHAT'S THE IDEAL REVIEW PANEL LOOKS LIKE FOR ALL STAGES OF THE REVIEW? THAT'S A HARD QUESTION, YOU KNOW, WHAT'S THE IDEAL REVIEW PANEL BUT WE HAVE TO COME TO GRIPS WITH THIS AND THEN THERE'S THE ISSUE OF INSTITUTIONAL DIVERSITY. AS YOU CAN SEE THIS IS EXUDE PRETTY HEAVILY TOWARDS SOME, YOU KNOW, RESEARCH-INTENSIVE INSTITUTIONS, AND SO SOME WOULD SAY WELL, WHAT DID YOU EXPECT AND OTHERS WOULD SAY WHAT ARE YOU DOING? I'M IN THE LATTER CAMP BY THE WAY. A PROUD GRADUATE OF A STATE UNIVERSITY SOMEWHERE. AND SO THEN THERE'S THE INSTITUTIONAL DIVERSITY BUT THERE'S ALSO THE DIVERSITY OF THE SCIENTIFIC TOPICS, SOMETHING THAT HANNAH VALANTINE AND HER COLLEAGUES HAVE LOOKED AT CAREFULLY, AND JUST ON A FIRST LOOK THERE CERTAINLY DOES SEEM TO BE AN UNDERREPRESENTATION AND AN OVERREPRESENTATION OF CERTAIN TOPICS IN THESE HRHR AWARDS. SO THINGS THAT REQUIRE A GREAT DEAL OF COLLABORATION, POPULATION STUDIES, EPIDEEMLOGY. HEALTH OUTCOMES, HEALTH DISPARITIES THESE TEND NOT TO BE TOPICS IN THE HRHR SCHEMA, AND IS THAT BECAUSE THESE ARE PERSON-BASED VERSUS TEAM-BASED AND SO WE NEED TO LOOK AT THAT. FINALLY SOME OTHER CONSIDERATIONS THE STRATEGY TO INSPIRE INNOVATION. THE CHARACTERISTICS OF IDEAL OF HIGH RISK FUNDING -- YOU KNOW, HOW CAN YOU ASSESS EVERYBODY USE DARPA AS THE POSTER CHILD. MAYBE IT IS, MAYBE IT ISN'T, BUT, YOU KNOW, WHAT CAN WE LEARN FROM OTHER ORGANIZATIONS. THE TIMELINE -- BRENDON WILL GET TO TELL YOU THE FIRST SET OF INITIAL RECOMMENDATIONS IN DECEMBER AND THEN WE'LL TELL YOU THE FINAL RECOMMENDATIONS A YEAR FROM NOW. AND WITH THAT INK I GOT BACK SOME OF THE TIME AT LEAST SO THANKS AND WE CAN ANSWER MAYBE ONE OR TWO QUESTIONS BEFORE THE BRAIN PEOPLE COME UP. >> SPKR1 QUESTIONS /* >> QUESTIONS? >> SO FEWER WOMEN APPLYING THESE ARE -- >> NOT THE PIONEER AWARDS. >> OH, NOT THE PIONEERS. >> BUT FOR THE ONES THAT ARE. >> NOT THE TRANSFORMATIVE -- >> OKAY. NONE OF THEM ARE. [LAUGH] I WITHDRAW MY QUESTION. [LAUGH] >> 2 OUT OF 4 ARE FOR MORE JUNIOR PERSONS AND DID REMAINDER. >> EXCEPT FOR THE REQUIREMENTS WHETHER THERE'S ANY TIME LIMIT, AGE-BASED TIME LIMIT OR TIME FOR TERMINAL DEGREE ONE BILATERAL DIFFERENCE IS CHILD BEARING AT THIS AGE, RIGHT? >> RIGHT. >> IS THERE ENOUGH PROVISIONS TO DISCOURAGE WOMEN FROM TARGETS A FAMILY? [SPEAKER AWAY FROM THE MIC] >> THE NEW INNOVATOR ARE FOR ESIs THE OTHER -- SO AGE BAS BASDE IS RIGHT OUT OF GRADUATE SCHOOL. >> THAT IS FROM A NUMBER OF YEARS FOR TERMINAL DEGREE AND IF WOMEN TAKE MATERNITY LEAVE ONCE OR TWICE DURING THAT TIME PERIOD. >> RIGHT. >> WITH OUR EXPANSION OF THE SI DEFINITION MAYBE THAT'LL BE MITIGATED BUT IT IS ONE DIFFERENCE. >> GOING BACK TO THE OTHER WORKING GROUP. IS ALLOWING AN APPLICATION FOR AN EXTENDED PERIOD CURRENTLY ON THE TABLE OR IS THAT -- >> IS THERE ANYTHING FURTHER FROM THIS GROUP THAT YOU'RE RESPONSIBLE FOR. >> THE GOAL IS TO LOOK AT ALL ASPECTS OF THE PIPELINE ISSUE AS WELL AS THE INPUT AND HOW DO WE ATTRACT THEM AND FINALLY THE REVIEW, AND I DON'T THINK THERE'S GOING TO BE SOME MAJOR DISCOVERY BUT PERHAPS SORT OF AN AGGREGATE CHANGING ON THE NUANCING OF THAT PROCESS MIGHT IMPROVE THINGS. /* >> JEFF. >> I THINK YOU SAID FEWER WOMEN ARE ACTUALLY APPLYING FOR THESE AWARDS AND THAT'S THE FRONT END AND HOW WOULD THAT BE ADDRESSED. I WASN'T COMPLETELY CLEAR HOW YOU WOULD GET DATA ON THE WOMEN WHO ARE CANDIDATES FOR THESE AWARDS BUT SOMEHOW ARE DISSUADED. >> THERE ARE SEVERAL THINGS THAT THE COMMITTEE SORT OF TALKED ABOUT DOING. ONE IS A CONCERN THAT THE FOAs ARE SOMEHOW OFFPUTTING TO WOMEN, AND ONE OF OUR COMMITTEE MEMBERS IS AN EXPERIMENT AT EXPERIMENT -- EXPERT AT TEXT MINING AND SO WE'RE GOING TO TAKE ADVANTAGE OF HER EXPERTISE. OTHER OPTIONS ARE ARE WE REALLY GETTING THE WORD OUT OR ARE WE JUST ALLOWING IT TO DIFFUSE THROUGH THE NATURAL NETWORK AND MAYBE THE NATURAL NETWORK ISN'T INCLUSIVE AND MAYBE WE HAVE AN OUTREACH TO WOMEN SCIENTISTS. I DON'T KNOW. BRENDON? >> YEAH, I THINK, YOU KNOW, DETERMINING A CONTROL GROUP WOULD HELP TO PERHAPS GISOME INSIGHT -- GIVE SOME INSIGHT ON THAT ISSUE AND WHAT ARE THE PROCEDURES, YOU KNOW, FOR THE ESTABLISHED RO1 OR OTHER TYPES OF GRANTS. THAT'S ONE STRATEGY TO THINK ABOUT. WHY THE DIFFERENCE? AND ALSO THERE'S CLEARLY A SKEWING TERMINALS OF ORIGINS. THAT CAN BE ADDRESSED. >> AND JUST TO MENTION ON THAT, WHEN ONE DOES LOOK AT THE PERCENTAGE OF APPLICANTS FOR R01s, FIRST TIME RO1s THAT IS ALSO, UNFORTUNATELY, NOT THE SAME AS THE PROPORTION OF DOCTORAL TRAINS COMING IN PID OR MD PH.D. D PROGRAMS THERE ARE FEWER WOMEN COMING IN FOR A PRINCIPLED INVESTIGATOR POSITION IN NUMBERS THAT ARE IN THE NEIGHBORHOOD OF 25 TO 30% OF THE TOTAL RATHER SIMILAR TO WHAT YOU SEE. SO DO NOT THINK THAT SOMEHOW THESE PROGRAMS ARE AN ANOMALY IN TERMS OF THEIR ABILITY TO BE ATTRACTIVE TO WOMEN APPLICANTS. WE HAVE A BROADER ISSUE THAN THAT AND SO WITHOUT MAKING YOUR CHARGE EVEN BROADER THAN IT ALREADY IS, I HOPE WHAT YOU LEARN ABOUT THE HRHR INFORM US ABOUT THE REST OF THE PORTFOLIO. ROY? >> YOU KNOW, WE JUST DEALT WITH THE SAME -- THE SAME ISSUE EARLIER IN THE WEEK AT THE BOARD MEETING FOR NAACP IN TERMS OF AWARDS IT SKEWED TOWARDS MEN AND I APPLAUD ALL THESE DIFFERENT ISSUES NIH AND NAACP AND TRYING TO MAKE A DIFFERENCE IN THEIR ATMOSPHERE SPHERE OF INFLUENCE BUT THIS IS A DEEP SOCIETAL ISSUE THAT INCLUDES GENDER PAY GAPS AND ALL KINDS OF THINGS -- YOU KNOW, WE JUST GOT AS A SOCIETY. IT'S JUST MY SOAP BOX HERE FOR A SECOND. AS A SOCIETY JUST NEED TO DO SOMETHING THAT'S MUCH BIGGER THAN THESE INDIVIDUAL EFFORTS WITHIN OUR INDIVIDUAL SPHERES OF INFLUENCE TO DO SOMETHING ABOUT BUT THIS IS A DEEP SOCIETAL ISSUE. IT'S ABOUT TIME. WE GOT TO DEAL WITH IT AS A SOCIETY. >> OKAY. THANK YOU VERY MUCH, EVERYBODY. WE HAVE ONE MORE MAJOR TOPIC TO DISCUSS BEFORE WE CAN CONSIDER OUR DAY ADJOURNED. LARRY IS RUNNING OFF TO DO LILT MORE COOKING BUT THE REST OF US WILL BE HERE AND I THINK VERY MUCH WANTING TO PAY CLOSE ATTENTION TO THIS PRESENTATION WE'RE ABOUT TO HEAR OF THE BREENE 2.0. IS JOHN ON THE PHONE? >> YES, I'M HERE NOW. >> OH, GREAT, JOHN. SO JOHN IS COCHAIR OF THE WORKING GROUP ON BRAIN 2.0 AS WELL AS INDICATE DULOCK. JOSH IS GOING TO WALK YOU THROUGH THE STATUS OF THIS EFFORT. JUST TO QUICKLY SET THE STRAIN. THE BRAIN INITIATIVE WAS ANNOUNCED IN 2013 THE SCIENTIFIC VISION OF APPLICATION OF NEW TECHNOLOGIES THAT WILL ENABLE RESEARCHERS TO PRODUCE DYNAMIC PICTURES OF THE BRAIN THAT SHOW HOW INDIVIDUAL CELLS AND COMPLEX NEURAL CIRCUITS INTERACT AT THE SPEED OF THOUGHT. AND OVER THE LAST 5 YEARS THE BRAIN INITIATIVE HAS MADE SIGNIFICANT PROGRESS TOWARDS THE PRIORITY OR AREAS THAT WERE OUTLINED IN THE ORIGINAL VISION FOR THIS PROJECT WHICH AS I MENTIONED THIS MORNING WAS PUT TOGETHER BY A WORKING GROUP OF THE ACD LED BY CORY BARGAINA AND BILL NEWSOM AND I THINK IT'S IF THERE IS VERITIES /* -- FAIR TO SAY IT'S FAIR TO SAY THAT THE SCIENCE IS MOVING VERY QUICKLY. BRAIN 2025 THE REPORT THAT THE TEAM PUT TOGETHER NO, I DID THAT THIS HAD TO ADAPT AND RESPONSE IN EVOLVING SCIENTIFIC LANDSCAPE CHANGES WHICH WERE INEVITABLE AND THAT, IN FACT, HAS BEEN THE CASE AND WE THOUGHT IT WOULD BE WISE TO CONVENE A NEW WORKING GROUP OF THE ACD WHICH WE'RE AFFECTIONATELY REFERRING TO BRAIN 2.0, TO PROVIDE SCIENTIFIC GUIDANCE TO THE ACD ABOUT HOW BEST TO MAKE SURE THIS VISION, A 10-YEAR VISION, GOES FORWARD IN THE MOST PRODUCTIVE WAY IN ITS SECOND HALF. AND SO THIS WORKING GROUP HAS BEEN CHARGED TO REVISIT THE STRATEGIC PLAN THAT WAS PUT FORWARD AND THE ORIGINAL BRAIN 2025 REPORT, REVIEWING WHAT'S HAPPENING IN TERMS OF ONGOING BRAIN INITIATIVE ACTIVITIES IN PROGRESS AND THEN SUGGESTING UPDATES TO SPECIFIC GOALS IN THE REPORT REFRESHING THE IDEAS, IDENTIFYING NEW OPPORTUNITIES FOR RESEARCH AND TECHNOLOGY DEVELOPMENT, PAYING ATTENTION TO A SOLID ETHICAL FRAMEWORK WHICH JOSH AND WALTER WILL SAY SOMETHING ABOUT AND HOW THAT BRAIN CAN BE NOT JUST A CLOSED SHOP BECAUSE THAT'S NOT THE GOAL. IT'S TO REACH AND EMPOWER THE BROADER NEUROSCIENCE GROUP. THIS ACD WORKING GROUP IS GOING TO PROVIDE US WITH A HIGH-LEVEL INTERIM UPDATE IN DECEMBER AND THEN THE FINAL REPORT WILL BE CONSIDERATION IN JUNE 2019 BUT THIS SEEMED LIKE A VERY GOOD MOMENT TO HEAR ABOUT WHAT THE PLAN ACTUALLY LOOKS LIKE AND SO WE TURN IT OVER TO JOSH WHO SEEMS TO BE AT THE MICROPHONE. SO JOSH GORDON DIRECTOR OF THE NATIONAL INSTITUTES OF MENTAL HEALTH. >> WHAT HE SAID. >> NO YOU GOT TO DO MORE THAN THAT. >> YEAH, OKAY. SO WE WANTED TO GIVE YOU AN UPDATE ON OUR PLANS FOR THE ADVISORY COMMITTEE TO THE DIRECTOR'S BRAIN INITIATIVE WORKING GROUP. WE'RE CALLING IT 2.0 FOR LACK OF A BETTER TERM. SO AS YOU ALL KNOW, THE BRAIN INITIATIVE WAS ESTABLISHED AND WAS JUST MENTIONED BY AN ACD WORKING GROUP THAT REALLY STARTED IN 2013. THE -- AS YOU PROBABLY ALSO KNOW, THE FUNDING STARTED AT THAT POINT BUT REALLY GOT GOING A COUPLE YEARS LATER SO WE'RE BASICALLY IN OUR 4TH YEAR OF SIGNIFICANT FUNDING FOR BRAIN. WE HAD LOTS OF SCIENTIFIC ADVANCES SO I'LL GO THROUGH SOME OF THOSE AND THEN WE'LL TALK ABOUT SORT OF MOVING FORWARD INTEGRATING NEUROETHICS MORE TIGHTLY IN THE BRAIN ETHICS AND IN THE SECOND HALF OF THE BRAIN INITIATIVE WHICH WE'RE CALLING 2020 TO 2026. SO ESTABLISHING THE BRAIN INITIATIVE, BRAIN INITIATIVE WAS FOUNDED ON THE NOTION THAT NEW DIRECTIONS IN SCIENCE ARE LAUNCHED BY NEW TOOLS MUCH MORE OFTEN NEW CONCEPTS THOSE ARE THE WORDS OF FREEMAN DYSON. IT BUILDS ON PROGRESS TO CREATE TOOLS THAT WE HOPE WILL ACCELERATE DISCOVERY AS FRANCIS MENTIONED THROUGHOUT NEUROSCIENCE. IT WAS CONCEIVED OF IN 2013 AND ANNOUNCED AT THAT POINT, AND THE PURPOSE WAS TO ACCELERATE DEVELOPMENT, APPLICATION OF INNOVATIVE TECHNOLOGIES TO CONSTRUCT WHAT WE HOPE WILL BE A TRULY DYNAMIC PICTURE OF BRAIN FUNCTION THAT INTERGRATES NEWER JOANAL ABILITY AND RECOGNIZING TECHNOLOGY DEVELOPMENT WE WANTED TO ENSURE THAT THE EFFORT WAS BUILT ON A GROWING SCIENTIFIC FOUNDATION THAT INCLUDED NOT ONLY NEUROSCIENCE AND OTHER BIOMEDICAL AREAS BUT PHYSICS, ENGINEERING, ET CETERA. THE BRAIN INITIATIVE WAS LAUNCHED WITH THIS GROUP OF THE ADVISOR COMMUNITY -- THROUGH THE DIRECTOR, HEADED BY CORY BARGMAN AND CORY NEWSAM AND WITH INSTITUTION WITH SEVERAL PEOPLE AT THE NIH WHO ORIGINALLY CREATED THE BLUEPRINT AND IS USED TO WORKING TOGETHER TOWARDS AN AIM. THAT GROUP HELD 4 WORKSHOPS OVER THE COUNTRY OVER THE SPRING AND SUMMER OF 2013 TO GET OUTSIDE OPINIONS. EACH OF THOSE WORKSHOPS WERE BROUGHT TOGETHER OUTSIDE OF EXPERTS BUT THEY WERE ALSO OPEN FOR PUBLIC COMMENTARY. AND THEN THE GROUP PUT TOGETHER THE BRAIN 2025 REPORT WHICH SET THE LEVEL, IF YOU WILL, OF THE NEUROCIRCUIT AS THE FOCUS OF THE BRAIN INITIATIVE, RECOGNIZING THAT NEURAL CIRCUITS ARE THE ELEMENTS OF THE BRAIN THAT CONTROL HOW WE MOVE, HOW WE PLAN, HOW WE EXECUTE, HOW WE REMEMBER, AND RECOGNIZING ALSO THAT THE DEVELOPING TECHNOLOGIES TO MONITOR AND MANIPULATE THESE CIRCUITS ON A TRULY LARGE SCALE WITH THE TRULY FINE TEMPORAL RESOLUTION WOULD ENABLE US TO UNDERSTAND HOW THE BRAIN FUNCTIONS AND HOPEFULLY ENABLE US TO UNDERSTAND HOW THE BRAIN FUNCTION GOES AWRY DURING A NEUROLOGICAL PSYCHIATRIC DISORDERS. THE WORKING GROUP DEFINES 7 HIGH-PRIORITY RESEARCH AREAS INCLUDING BRAIN CELL TYPES, TOOLS FOR BUILDING CIRCUIT DIAGRAMS, MAPPING ACTUALLY AT MULTIPLE SCALES, DOTOOLS FOR MONITORING FOR ACTION AND CAUSE JOEL OF THAT -- CAUSE ALITY AND FUNDAMENTALS ABOUT HOW THE BRAIN WORKS AND TWO INTEGRATIVES IMPORTING TOOLS INTO HUMAN USE AND THE OTHER AIMED AT REALLY INTEGRATING MULTIPLE APPROACHES TO TRULY UNDERSTAND THE BRAIN. SO WHAT HAVE WE DONE WITH THAT PLAN SINCE ITS INCEPTION? WELL, WE'VE HAD A NUMBER OF YEARS OF AWARDS GIVEN OUT STARTING IN SEPTEMBER, 2014. WE'VE HAD NOW 4 MEETINGS OF THE PRINCIPLED INVESTIGATOR FROM THOSE AWARDS WHICH GREW FROM A COUPLE OF HUNDRED TO NOW ABOUT A THOUSAND PEOPLE WHO ATTENDED THE MOST RECENT BRAIN THE PRINCIPLED INVESTIGATOR MEETING WHICH WAS IN HELD, AND MOST IMPORTANTLY THE -- THE FUNDING FOR THE BRAIN INITIATIVE WAS AUTHORIZED IN THE 21ST CENTURY KERR ZACH THAT WAS SIGNED INTO LAW IN DECEMBER OF 2016 AND THE OTHER POINT I WANT TO POINT OUT IN THIS GRAPH IS THE ESTABLISHMENT OF THE NEUROETHICS DIVISION OF THE MULTI COUNCIL WORKING GROUP THAT ADVISES THE BRAIN INITIATIVE IC DIRECTORS AND DR. COLLINS ON HOW TO PURSUE THIS PATH. THE NEUROETHICS WAS ESTABLISHED IN IT 2015 AND WALTER WILL HAVE MORE TO SAY ON THAT IN A MOMENT. ALTHOUGH WE'RE NEARING THE HALFWAY POINT IN TERMS OF TIME WE'RE NOT NEARING THE HALFWAY POINT REALLY IN TERMS OF DOLLARS AND SO INITIALLY THE ALLOCATIONS FOR THE BRAIN INITIATIVE WERE SMALL. THEY'VE GROWN DRAMATICALLY OVER TIME, MUCH THANKS TO THAT 21ST CENTURY -- 20th CENTURY -- 21ST CENTURY KERR ZACH AND THEN YOU CAN SEE AS WELL OUR INVESTMENTS IN SOME AREAS LIKE CELL TYPES, CELL CIRCUIT TOOLS, NEURAL RECORDING MODERATION HAVE BEEN PROPORTIONATELY GROWING OVER TIME AND AREAS LIKE NEUROETHICS AND INFORMATICS ARE WHAT WE BUILDING MORE IN THE FUTURE. THOSE FUNDS HAVE BEEN SPREAD OUT IN -- NOT ONLY ILLUSTRATED HERE GEGRAPHICCALLY ACROSS THE UNITED STATES AND INDEED ACROSS THE WORLD WITH 345 AWARDS SINCE THE BRAIN BEGAN WITH GOING TO 504 INVESTIGATORS. THIS IS THROUGH LAST YEAR FISCAL YEAR 2017. BUT ALSO IN TERMS OF THE SCIENTISTS INVOLVED PARTICULARLY THE DISCIPLINES OF THE SCIENTISTS AS OF 2017, MORE WORDS HAD GONE TO ENGINEERS THAN TO NEUROSCIENTISTS. THERE'S BEEN LOTS OF PUBLISHED FINDINGS. LOTS OF FANTASTIC TOOLS DEVELOPED. OVER 450 PUBLICATIONS OF THE BRAIN PUBLISHED OVER DATE WHICH IS PRETTY ASTOUNDING SINCE IT STARTED ONLY 4 YEARS AGO. ONE PARTICULAR I WANT TO HIGHLIGHT WHICH IS THE FIRST PRODUCT OF THE BRAIN INITIATIVE THAT WILL BE TRULY TRANSFORMATIVE OF THE NEUROSCIENTISTS COMMUNITY AT-LARGE IS THE BRAIN CONFERENCCENSUS CELL NETWORK. IT REPRESENTS A $250 MILLION EFFORT TO CATALOG A PARTS LIST OF THE BRAIN AND MOUSE NONHUMAN PRIMATE AND HUMAN. THE END GOAL OF THE CELL CENSUS NETWORK IS TO CREATE A 3D BRAIN CELL ATLAS AND AS A NEUROSCIENTIST WORKING IN NEURAL CIRCUITS I CAN TELL YOU HOW VALUABLE THIS WOULD. I WOULD NO LONGER HAVE TO MAKE UP CHARACTERISTICS OF THE INDIVIDUAL CELLS AND IT WOULD HAVE BEEN DONE FOR ME IT'S ANALOGOUS IN THE GENE JIMMIE JOHNSON AND CREATING A REFERENCE POINT BUT IT'S NOT ABOUT THE GENES BUT IT'S ABOUT THE GENETIC BUILDING BLOCKS BUT RATHER THE CELLULAR BUILDING BLOCKS OF THE BRAIN. SOME PRETTY AMAZING TECHNOLOGIES COME OUT OF IT INCLUDING THAT ILLUSTRATED ON THIS SLIDE. THIS IS WORK THAT COMES OUT OF MICHAEL'S LAB WHERE HE'S ABLE TO COME OUT IN THE MIDDLE SLOT IMAGE WATCH THE ACTIVITY OF THE PRODUCE PERFORMED BEHAVIOR AND LET'S LOOK AT THE MACRO SCALE ASSOCIATED WITH BEHAVIOR BUT ON THE RIGHT-HAND SIDE SLIDE LOOK WITHIN A PARTICULAR SECTION OF THAT MOUSE BRAIN AT MULTIPLE SINGLE SCALE. IT HAS MANY IMPLICATIONS UNDERSTANDING THE MICROSCALE ACTIVITY AND THE MACROSCALE ACTIVITY THAT WE CAN MANAGE IN HUMANS WITH FUNCTIONAL MAGNETIC RESONANCE AND OTHER ACTIVITIES SO WE CAN BEGIN TO GET AN UNDERSTANDING WHAT ARE THE NEURAL UNDERPINNINGS OF THIS KIND OF WORK. SIMILARLY WE CAN IMAGE DEEP IN THE BRAIN THIS IS AND SO ARE THE -- IN FACT, THE BRAINSTEM. THESE ARE IMAGES OF NEURONS IN THE TRIJENGENERAL GANGLION WHICH FOCUS ON SPECIFIC CIRCUITS WHICH CARRY OUT CERTAIN FUNCTIONS AND ONE OF THE AREAS OF GREAT EFFORT IS RESEARCH ON THE FUNDAMENTAL NERVE BIOLOGIST OF PAIN PROCESSING WHICH WE HOPE ADDRESS THE NEEDS OF FOR NOVEL THERAPEUTIC THAT IS NONOPIATE-BASED BUT IT ALLOWS READOUTS TO HELP US UNDERSTAND -- AND IN THE BRAIN AND A VERY FINE SPATIAL END AND TEMPORAL RESOLUTION AND THIS WILL ALLOW US TO MAP OUT THE DOPE PEEN IN THE LIVING PLAIN AND THE ROLE IT PLAYS IN LEARNING IN UNPRECEDENTED DETAIL AND THAT WAS RECENTLY PUBLISHED SO THESE ARE THE ACHIEVEMENTS OF THE BRAIN INITIATIVE SO FAR FROM A SCIENCE PERSPECTIVE ONE MORE SCIENCE HIGHLIGHT BEFORE I BRING UP MY PARTNER IN CRIME WALTER AND WEIR ALREADY SEEING THE BENEFITS -- [BACKGROUND NOISE] >> THIS IS A PATIENT WHO HAS A BENIGN TREMOR. HE HAS MUCH DIFFICULTY USING HIS ARMS TO POUR WATER IN THIS CASE BECAUSE OF ABNORMAL ACTIVITY PATTERN IN THE BRAIN WE CAN CHANGE THE PATTERN TO MAKE THE TREMOR GO AWAY BUT AS WHAT'S ILLUSTRATED ON THE RIGHT-HAND SIDE NOT ONLY DO YOU HAVE THE DEEP BRAIN STIMULATOR IMPLANTED DEEP IN THE STRIATUM WHICH IS ABELATING THE ABNORMAL ACTIVITY WHICH CAUSES THE TREMOR BUT ALSO THESE ADDITIONAL ELECTRODES IN OTHER PARTS OF THE BRAIN WHICH ALLOWS A CLINICIAN TO READ OUT THE ADVANCE -- NOT THE CLINICIAN BUT THE COMPUTER WHEN THE MOTION IS STARTING. MY AUNT HAS ONE OF THESE DEEP BRAIN STIMULATORS IMPLANTED WITHOUT THESE RECORDINGS AND SHE IS PERMANENTLY HOARSE OF VOICE UNLESS SHE TURNS OFF THE TRANSMITTER AND OF WHICH CASE HER TREMOR BEGINS AND THEN THIS GENTLEMAN IS ABLE TO MAINTAIN MINIMIZED SIGN EFFECTS BUT ONLY HAVE STIMULATION WHEN THE MOTOR IS ENGAGED SO WE'RE ALREADY BEGINNING TESTIMONIALS THE FRUITS OF TECHNOLOGIES -- TECHNOLOGIES OF THE FRUIT OF TECHNOLOGIES, AND I'LL SEND IT OVER FROM THE PAST TO THE FUTURE. >> THANK YOU SO MUCH, JOSH AND WE'LL TALK ABOUT 2 TOPICS ONE IS NEUROETHICS AND HOW IT'S RELATED TO THE BRAIN INITIATIVE AND HOW WE'RE DOING THERE AND TALK ABOUT THE PLANS THAT JOHN MANSFIELD IS GOING TO CARRY OUT IN THE 2.0 PROCESS. SO RIGHT FROM THE BEGINNING IT WAS PRETTY CLEAR THAT THE BRAIN INITIATIVE -- BECAUSE IT WAS TARGETING MODULATING AND MONITORING NEURAL CIRCUITS WAS GOING TO HAVE SOME UNIQUE NEUROETHICAL CONSIDERATIONS FROM THE BRAIN 2025 REPORT THERE'S THIS TEXT BECAUSE THE BRAIN GIVES RISE TO CONSCIOUSNESS AND BASIC NEEDS AND IT'S RESULTED IN NEW ETHICAL AND SOCIAL QUESTIONS. I THINK JOSH IS THE LAST EXAMPLE. THAT JOSH GAVE WHERE THERE'S SOMEONE WHO HAS A CHRONIC NEURAL RECORDING DEVICE WHICH IS ATTACHED TO A CLOSED LOOP STIMULATOR BUT COLLECTING INFORMATION AS HE GOES ABOUT HIS DAILY BUSINESS AS WELL AS WHEN HE INTENDS TO MOVE SO CLEARLY YOU CAN SEE IMAGINE THESE KIND OF ETHICAL CONSIDERATIONS WHICH IS IMPORTANT WHICH IT'S RECOGNIZED EARLY ON BECAUSE WHEN THE BRAIN INITIATIVE WAS FIRST LAUNCHED THE PRESIDENT CHARGED THE BIOETHICS COMMISSION TO ACTUALLY PUT OUT A PAPER AND IT'S TWO VOLUMES CALLED GRAY MATTERS WHICH BROUGHT UP A LOT OF THE ISSUES THAT COULD BE EXPECTED GOING FORWARD. ETHICAL DILEMMAS RAISED BY THE APPLICATION OF THE FINDINGS THAT MIGHT COME OUT OF THE BRAIN INITIATIVE. SO THE KEY RECOMMENDATION FROM THIS GROUP, IF I HAD TO JUST BOIL IT DOWN WAS TO INTEGRATE NEUROETHICS IN THE BEGINNING INTO THE ALL THE NEUROETHICS PROGRAM FOLLOWING FROM BEHIND AND INTEGRATED RIGHT FROM THE BEGINNING. SO WE TOOK THIS TO HEART AND RIGHT FROM THE BEGINNING WE HAVE A GROUP THAT INFORMS US ON ALL THE DECISIONS THAT WE'RE MAKING IN THE BRAIN INITIATIVE AND WE HAVE A NEUROETHICS GROUP THAT LOOKS AT THE ISSUES WHICH IS INTEGRATING THE NEUROETHICS INTO THE RESEARCH. THIS DIVISION IS GUIDING OVERAFTERNOOOVE OVERAVERAGIING NEUROGOOIRNGZ AND IT INCLUDES PRAL -- PRACTICAL SUGGESTIONS, AND THEY ALSO HAVE DEEP DIVES IN PARTICULAR ISSUES AS THEY COME UP AND GIVE THE INVESTIGATORS ADVICE ON HOW TO BEST KEEP THE NEUROETHICS TIED TO THE SEARCH SO THERE HAVE BEEN TWO ALREADY. ONE ON THE ETHICAL ISSUES OF THE DEVICES WHICH W JUST MENTIONED. ONE OF THOSE AND ALSO WORKSHOP ON THE NEW TECHNOLOGIES WHICH CAN LOOK AT CIRCUIT ACTIVITY AND CELL DEVELOPMENT IN HUMAN NEURAL TISSUE WHETHER IT WOULD BE ORGANOIDS OR CHIMERIAS. LOOKING AHEAD TO 2026, AS FRANCIS AND JOSH MENTIONED THERE'S A NEW ACD WORKING GROUP THAT'S BEING PUT TOGETHER AND JOHN MANSEL WHO IS ON THE PHONE IS GOING BE CHAIRING THAT WITH CATHERINE DELOCK AND WE'LL TALK ABOUT THE COMMITTEE IN JUST A SECOND. JOSH DID MENTION THERE WAS A RAMP-UP PHASE TO THE BRAIN INITIATIVE AS YOU CAN SEE HERE AND WHAT'S THAT OBVIOUS IS THE GREATEST FUNDING IS YET TO COME IN THE BRAIN INITIATIVE, AND PROGRESS HAS BEEN MADE, I THINK, IS A GREAT -- PORTENDS GREAT THINGS TO COME BUT THEN LOTS OF DECISIONS TO BE MADE WHAT SHOULD THE SECOND HALF OF THE BRAIN INITIATIVE LOOKS LIKE. SECOND HALF WILL COME SOME TIME IN 2020 SO THE PROCESS IS NOW UNDERWAY TO TRY AND LOOK BACK AT THE BRAIN 2025 REPORT AND UPDATE IT TO GIVE US GUIDANCE FOR THE SECOND HALF OF THE BRAIN INITIATIVE, AND THERE HAS BEEN SIGNIFICANT PROGRESS AND WHEN THE BRAIN INITIATIVE STARTED, THERE WAS A LOT OF ANTICIPATION AND HIGH EXPECTATIONS AND -- BUT IN SOME AREAS THE PROGRESS HAS COMPLETELY EXCEEDED ALL EXPECTATIONS SO THERE HAVE BEEN SOME REALLY AMAZING ADVANTAGES, SO IT IS AN ON THAT TUNE TIME TO HAVE A LOOK-BACK WHAT SHOULD THE SECOND HALF LOOKS LIKE GIVEN THE KIND OF STEEP CURVE THAT WE'VE BEEN ON SO FAR. SO PEOPLE MAY RECALL THAT THE BRAIN 2025 REPORT -- THE GUIDANCE WAS IN THE BEGINNING IT WAS GOING TO FOCUS HEAVILY ON DEVELOPING TOOLS AND TECHNOLOGIES TO ALLOW US TO MODULATE AND MONITOR NEURAL CIRCUIT ACTIVITY AND THEN THERE WAS GOING TO BE A RAMP-UP LATER TO APPLY THOSE ACTIVITIES TO ACTUALLY REALLY FIGURE OUT ON YOU THESE CIRCUITS ARE WORKING AND WHAT IS THE SECRET OF INFORMATION PROCESSING IN THE BRAIN. AND SO THE BRAIN -- WORKING GROUP 2.0 WE'LL BE ABLE TO LOOK AT THIS AND AS JOSH MENTIONED THERE ARE THESE 7 PRIORITY AREAS THAT WE'VE BEEN WORKING ON AND MAYBE SOME NEW ONES, AND SOME OF THESE MAYBE LOOKED AT IN MORE DETAIL GIVEN WHERE WE ARE NOW. SO THEY'LL REVIEW THE BRAIN INITIATIVE ACTIVITIES IN THE PROGRESS AND CHECK THE CHANGES AND FOR THE SPECIFIC GOALS FOR THE BRAIN 2025 REPORT IN RESPONSE TO THE EVOLVING LANDSCAPE AND LOOK FOR INTELLIGENCE IN DEVELOPMENT AND COMES WITH A SIGNIFICANT FRAMEWORK AND TO TRAIN AND EMPOWER THE THE BROADER NEUROSCIENCE RESEARCH COMMUNITY. AND I THINK ALSO IN THE SECOND PHASE WIN WANTS TO PUT THINGS TOGETHER THAT CAN THEN TRANSLATE AND MAKE THE PROGRESS SUSTAINABLE OVER THE LONG RUN AND INTEGRATE IT BETTER INTO THE OVERALL NEUROSCIENCE EFFORTS THAT ARE GOING ON AT NIH. SO THIS IS A COMMITTEE. KATHERINE DELOCK AT HARVARD STUDIES CIRCUIT ACTIVITIES PRIMARILY BEHAVIORAL CIRCUITS IN MICE. JOHN MANSEL AT THE UNIVERSITY OF CHICAGO WHO STUDIES CIRCUITS IN BOTH NONHUMAN PRIMATES AND PRICE. DAVID ANDERSON STUDIES MICE AND TROSORT OF LA. ANNA IS A MATERIAL SCIENCE ENGINEER DEVELOPING OPTICAL MA MATERNAL SCIENTISTS TO MONITOR CIRCUITS, AND TO JOSE'S POINT I THINK SHE'S A GREAT EXAMPLE OF AN EARLY STAGE INVESTIGATOR. SHE GOT HER PH.D. IN 2009 AND GOT HER FIRST JOB IN 2011 AND GOT TENURED IN 2016 THAT'S WHAT AN EARLY STAGE INVESTIGATOR SHOULD BE DOING, AND I BELIEVE SHE WILL BE ONE OF THE ACD REPORTERS REPORTING TO YOU ON THE ACD -- ON THIS COMMITTEE. AND CARL DEZZOFF AT STANFORD ONE OF THE PIONEERS IN THIS SPAIN. KYLE DENNISON COMING FROM MEDTRONIC MAKING THE DEVICES AND REALLY UNDERSTANDS THIS PIECE OF DISSEMINATION AND COMMERCIALIZATION OF THESE TOOLS FOR HUMAN USE H-CAFEWY DEROZA FROM DUKE AGAIN, STUDYING CIRCUIT ACTIVITY IN MICE AND ADRIAN FAREWELL, ELIZABETH HILLMAN IS A BIOENGINEER DEVELOPING HUE TECHNOLOGI NEW TECHNOLOGIES TO LOOK AT BRAIN CIRCUITS. BRUCE ROSEN, MIRROR IMAGE PERSON. KRISHNA CONFRONTATIONAL ANALYSIS, AND DARRAH SOW A REALLY EXPERT IN VISUAL CIRCUIT PERSON AND HUDA ZOGBY REAL FORCE IN NEUROSCIENCE. AT THIS POINT PARTICULARLY ON THE DISEASE SIDE OF THINGS AND WE HAVE FEDERAL EX OFFICIO REPS WE SHOULD MENTIONED THAT IT'S -- WE'VE HAD TREMENDOUS RELATIONSHIPS WITH THE NATIONAL SCIENCE FOUNDATION AND THEY HAVE BRAIN INITIATIVE PROGRAMS AND VERY COMPLEMENTARY TO OURS AND, FOR INSTANCE, WE ACTUALLY JOINTLY FUND ONE ON COMPUTATIONAL DEFENSE AND DARPA, IARPA FROM THE INTELLIGENCE AGENCY ADVANCE RESEARCH PROGRAMS THAT HAVE WORKED IN THE BRAIN INITIATIVE. LARRY JORGENSON WHO WILL BE JOINING THE 2.0 GROUP AND CARLOS PINA FROM THE FDA -- HE'S ON THE DEVICE SIDE PARTICULARLY IMPORTANT IN MOVING THESE DEVICES OUT INTO PEOPLE. WE WILL AS WE HAVE IN THE MULTI COUNCIL WORKING GROUP HAVE A NEUROETHICS SUBGROUP THAT WILL BE INTEGRATING INTO THE WORK OF THE 2.0 WORKING GROUP AND THEY WILL BE DEVELOPING AN NIH BRAIN INITIATIVE, NEUROETHICS FOR THE NIH BRAIN INITIATIVE. THEY'LL REVIEW THE PRIORITY AREAS IN THE BRAIN 2025 AND THE UPDATES IN THE 2.2 GROUP AND PIN DOWN AND IDENTIFY THE ETHICAL IMPLICATIONS THAT MAY ARISE AS NEW TECHNOLOGIES COME AND AS THESE NEW TECHNOLOGIES APPLY TO VARNIN ADVANCING, AND THE GOALS OF MODULATING CIRCUITS AND HUMAN HEALTH, AND THEY'LL BE REPORTING FOR THE ACD WORKING GROUP FOR INCLUSION IN THE FINAL REPORT. WE HAVE JUST RECENTLY BEEN ABLE TO NAIL DOWN THE COCHAIRS, JANE EBBIWINE WHO HAS BEEN PART OF THE MULTI COUNCIL WORKING GROUP SINCE ITS INCEPTION AND JEFF KHAN WHO'S THE HEAD OF BIOETHICS AT HOPKINS. SO WE'LL LOOK FORWARD. THE TIMELINE IS GIVEN HERE. SO THIS PROCESS WAS ANNOUNCED AT THE BRAIN PI MEETING WHICH IS ABOUT 1,000 INVESTIGATORS HELD HERE IN APRIL AND WE HAD A TOWN HALL TO GET INPUT FROM THE INVESTIGATORS THERE. THE COMMITTEES COME TOGETHER. THEY'VE HAD MULTIPLE DIFFERENT MEETINGS AND THEY HAVE PLANNED WORKSHOPS AS DID THE INITIAL GROUP ONE OVER THE SUMMER AND FALL IN THESE SITES. THE HOPE IS THAT THE FINAL VERSION WILL BE RELEASED SOMETIME IN THE WINTER OF 2019 WILL BE THE DRAFT AND THEN SUMMER OF 2019 THE FINAL VERSION THAT WILL INFORM US TO START IN 2020 WHICH IS THE BEGINNING OF THE SECOND HALF OF THE BRAIN INITIATIVE SO THESE ARE JUST SOME FOOTAGE FROM THE BRAIN HALL MEETING WHICH WAS -- IT GOT LOTS AND LOTS OF INTEREST AND WE'LL HAVE AN RFI TO GET INFORMATION BROADLY FROM THE SCIENTIFIC COMMUNITY AND THAT WILL HELP INFORM THE WORK OF THE GROUP. AND SO THE WORK IS ONGOING AND AND GREAT APPRECIATION TO JOHN AND CATHERINE FOR RUNNING THIS REALLY IMPORTANT PROJECT, AND WITH THAT I'M HAPPY TO TAKE QUESTIONS. >> THANKS, WALTER AND JOHN. LET ME TURN TO JOHN ON THE PHONE TO SEE IF YOU WOULD LIKE TO COMMENT ABOUT THE JOB YOU'VE BEEN ASSIGNED HERE ALONG WITH CATHERINE. >> YEAH, JUST BRIEFLY I WOULD LIKE TO THANK OF THE GREAT OVERVIEW OF WHAT WE'RE DOING WITH THE BRAIN 2.0 AND A GREAT OPPORTUNITY TO TAKE PART IN THIS GREAT EFFORT WHICH IS, OBVIOUSLY, VERY IMPORTANT TO JUST TAKE A LOOK AROUND WHAT HAS BEEN ACCOMPLISHED AND SEE IF THERE ARE NEW OPPORTUNITIES OR PLACES WE CAN TUNE THINGS UP A BIT. BUT IN PARTICULAR, I'M LOOKING FOR TO WHAT HAS ALREADY BEEN A FASCINATING EDUCATION AND SOME REALLY IMPRESSIVE NEW SCIENCE AND THERE'S A LOT OF WORK AHEAD OF US BUT I THINK THE COMMITTEE IS REALLY GOING TO ENJOY THE PROCESS OF LEARNING WHAT'S BEEN GOING ON. SO I WILL JUST SAY IT'S VERY EARLY DAYS FOR US. WE HAVE HAD SEVERAL MEETINGS OF THE WORKING GROUP BY VIDEO CONFERENCE AND WE'RE STILL IN THE PROCESS OF SORT OF GETTING OUR FEET ON THE GROUND AND PLANNING OUT THE DETAILS OF THE WORKSHOP. AND I WILL ADD WE'RE ON A VERY AMBITIOUS SCHEDULE HERE. IT'S A LOT TO GET ACCOMPLISHED TO HAVE AN INTERIM TO REPORT BY DECEMBER. I'M OPTIMISTIC THAT WE'LL BE ABLE TO DO IT BUT IT'S GOING TO BE A LOT OF HARD WORK ON THE PART OF THE WORKING GROUP GOING FORWARD. >> THANKS. BRENDON? >> CONGRATULATIONS ON THE PROGRESS IN 1.0 AND I THINK, YOU KNOW, THINKING BACK ON THE JEAN GENOME PROJECT AND THE MODEL MAKES COMPLETELY SENSE BUT AT THE END OF THE DAY IT'S ON THE CLINICAL APPLICATION OBVIOUSLY BUT WE DON'T.0 IS COMPLETELY LOGICAL TO FOCUS ON DISCOVERY RIGHT NOW BUT IS IT TOO EARLY TO THINK ABOUT CLINICAL APPLICATION ESPECIALLY SINCE YOU HIGHLIGHTED AN EXCELLENT EXAMPLE OF SUCH AND PERHAPS TO INCORPORATE THAT INTO THE WORKING GROUP AS A NAME OR GOAL. >> RIGHT, SO -- SO THE PLAN HAS BEEN FROM THE BEGINNING TO KIND OF WORK OUR WAY UP AND YOU SAW SOME ZEBRA FISH AND MICE AND THAT'S A HEAVY PIECE OF IT BUT THE HUMAN RESEARCH IS HAS BEEN CARRIED ON AS WELL AND -- AND SO ALL THOSE HEAVILY ON THE STIMULATION SIDE OF THINGS BUT WE HAVE STIMULATION PROJECTS TO TRY TO HELP OCD, O DEPRESSION, DEPRESSIONS SO THERE ARE CLINICAL PROJECTS THAT ARE ONGOING ALREADY IN THE BRAIN INITIATIVE AND THE HOPE IS THAT THE KNOWLEDGE WILL BRING NEW TECHNOLOGIES TO BEAR CLINICALLY. IN ADDITION WE HAVE THIS ABILITY AND PEOPLE WHO HAVE FOR SOME REASON TO HAVE BASICALLY ELECTRODES ON THE BRAIN TO COLLECT ACTIVITY, THAT HELPS US UNDERSTAND HOW WE SPEAK, HOW WE THINK, THINGS LIKE THAT. SO THERE'S A LOT OF CLINICA STUFF GOING ON ALREADY. >> YEAH, THE CHALLENGE TO THIS NEUROETHICS SUBGROUP IS GOING TO BE TRY TO ALIGN THEMSELVES EFFECTIVELY WITH THE REALITY OF WHERE THE BRAIN INITIATIVE IS GOING 'CAUSE THERE'S GOING TO BE PLENTY OF ISSUES TO WHERE I FEEL LIKE ORGANOIDS AND HUMAN APPLICATIONS NONHUMAN PRIMATES ARE GOING TO BE IN THIS MIX. IT'S THE FIRST TIME JEFF KHAN HAS BEEN DISCUSSED IN MANY OF THOSE DISCUSSIONS SO WE DON'T HAVE TO REINVENT THOSE CONVERSATIONS BUT 3W457 WANT TO AVOID IS -- BUT WHAT WE WANT TO AVOID IS DISCUSSIONS THAT GO IN THE WILD, WILD FAR BLUE YONDER OF THINGS THAT ARE NOT REALLY SO PR PRACTICAL AND PROXIMAL. I DON'T THINK WE WANT THEM TO DEBATE THE PROS AND CONS OF WEAPON DEVICES OF HUMAN BRAIN FUNCTIONS SO LET'S KEEP IT CROWDED IN THIS KIND OF THINGS THAT THE BRAIN INITIATIVE NEEDS TO ACHIEVE IN THE NEXT 5 OR 6 YEARS. >> YES, I WANTED TO ECHO THE CONVERSATIONS AND I BET CONGRESS WOULD BE EXCITED TO SEE THAT TRANSITI TRANSLATIONAL RELATIONSHIP THAT COMES OUT AS LONG AS YOU FEEL IS APPROPRIATE. AND AND ALONG THOSE LINES I WOULD LIKE TO HOW THIS INITIATIVE INTERFACES WITH INDUSTRY SINCE -- THOSE KINDS OF PARTNERSHIPS COULD BE VERY VALUABLE AS WELL AS FACILITATE TRANSLATION. I'M NOT SURE I SAW ANY INDUSTRY TRANSLATION IN WHAT YOU PRESENTED TODAY. >> SO THE INDUSTRY PARTICIPATION HAS BEEN ON TWO AREAS. ONE IS IN THE INVASIVE DEVICES WE ACTUALLY HAVE RELATIONSHIP WITH MULTIPLE DIFFERENT COMPANIES WHERE WE DEVELOP TESTIMONY PLATES FOR OUR INVESTIGATORS TO APPLY WITH INDUSTRY TO GET THEIR LATEST INVESTIGATIONAL DEVICES TO BRING INTO THE STUDIES SO THERE'S A LOT OF NAT SPACE COMING IN WITH A LOT OF PARTNERS AND THE OTHER SPACE IS THE DEVELOPMENT OF THESE NOVEL LABORATORY DEVICES PARTICULARLY ON THE MICROSCOPY SIDE SO THERE'S A LOT OF COMPANIES WHO HAVE FORMED KIND OF COMMERCIALIZED THOSE AND SELL THOSE. BUT I THINK THAT IS CERTAINLY THE DISSEMINATION PIECE IS SOMETHING THAT WE CERTAINLY -- THE SECOND HALF HAVE TO REALLY KIND OF REENERGIZE TO GET THOSE TOOLS OUT THAT HAVE BEEN DEVELOPED SO THAT EVERYBODY GETS A CHANCE TO DEVELOP THEM AND THE CLINICAL ONES THAT CAN GO ON TO COMMERCIALIZATION SO THE BRAIN INITIATIVE DOES HAVE THE SAME REQUIREMENTS CALLED BUSINESS GRANTS SO THERE'S A LOT OF SMALL BUSINESS ACTIVITY IN THE SPACE RIGHT NOW. JOSH? >> I WOULD JUST ADD WITH REGARD TO THE FIRST PART IN WHICH YOU WERE SAYING ALONG CLINICAL OUTPUTS. I THINK IT'S REALLY HELPFUL WITH REGARD TO OUR SUPPORTERS IN VARIOUS STAKEHOLDER GROUPS INCLUDING CONGRESS BUT ALSO I THINK IT'S BROADLY RECOGNIZED THAT THE BRAIN INITIATIVE IS A DISCOVERY INITIATIVE. IT'S ABOUT TOOL DEVELOPMENT AND ABOUT BUILDING THE BRAIN AND THE EXPECTATION, OF COURSE, IS THAT THAT WILL LEAD TO IMPROVEMENTS CLINICALLY BUT THE PRODUCTS THAT THEY'RE LOOKING FOR -- THEY'RE THINKING ABOUT AT LEAST IN MY ESTIMATION INTERACTING WITH CONGRESS IN THE LAST COUPLE OF YEARS IS VERY MUCH LIKE THAT HUMAN GENE JIMMIE JOHNSON PROJECT SETTING THE STAGE FOR GREAT SCIENCE TO COME IN THE FUTURE. >> AND THE CONGRESS GETS IT THAT WHILE THIS IS A PRETTY BIG INVESTMENT THAT THEY SUPPORTED -- THIS IS STILL EVEN WHEN FULLY FUNDED IN THE NEXT YEAR OR SO IS GOING TO REPRESENT MAYBE 10% OF WHAT NIH IS SPENDING IN NEUROSCIENCE SO THE EXPECTATION IS THIS IS A FOUNDATIONAL PLATFORM OF TECHNOLOGY DEVELOPMENT AND APPLICATIONS FOR HUMAN ILLNESS WILL LARGELY BE DIN WITH THE OTHER 90% -- DONE WITH THE OTHER 90%. >> QUARTERBACKS IF I HAD TO GUESS THE FUTURE, I WOULD -- YEAH, IF I HAD TO GUESS THE FUTURE IS WHAT THE BRAIN INITIATIVE WILL PUT THESE ELECTRODES OUT OF BUSINESS BECAUSE WITH THE GREAT ADVANCEMENT OF BRAIN ENHANCEMENT IS THE ABILITY TO IDENTIFY SPECIFIC CELL TYPES AND TARGET THEM WITH GENOMIC TOOLS TO EITHER TURN ON OR TURN OFF THESE CELLS WITH INCREDIBLE PRECISION SO THE FACT THAT THAT ELECTRODE WORKS IS LIKE A MIRACLE 'CAUSE WE HAVE NO IDEA WHAT IT'S DOING. [LAUGH] >> AND -- AND -- BUT I THINK ONCE WE -- AND SO THESE -- SO I THINK THESE TECHNIQUES, THEY'RE BEING -- THEY'RE BEING REALLY DEVELOPED TO A HIGH EXTENT IN THE MOUSE. NEXT STEP, I THINK, IS GOING TO BE THEY'RE GOING TO BE DEVELOPED IN NONHUMAN PRIMATES AND THEN WITHIN A COUPLE OF YEARS PEOPLE ARE GOING TO TRY TO USE THEM IN PATIENTS WHO REALLY REQUIRE, YOU KNOW, THIS TYPE OF PREDECISION MODULATION OF THEIR CIRCUITS AND IF I HAD TO GUESS THAT'S GOING TO BE THE ONE OF THE EARLIEST BIG IMPACTS OF THE BRAIN INITIATIVE. >> ANY OTHER COMMENTS, QUESTIONS? ORN, ANYTHING ELSE FROM YOU ON THE PHONE? >> NO, I'LL JUST ADD MY AGREEMENT WITH WHAT JOSH JUST SAID. >> OKAY. AND AS WAS MENTIONED ANN CHURCH LAND WHO IS JOINING THE ACD BUT COULD NOT BE HERE TODAY WILL HAVE A DUAL ROLE OF AN ACD MEMBER AND ALSO BE PART OF THIS WORKING GROUP. WE ALWAYS LIKE TO HAVE THAT LINKAGE IDENTIFIED AND SHE WILL BE CARRYING OUT THAT ROLE, BUT SO ACD MEMBERS, WHAT YOU WILL EXPECT THEN IS IN DECEMBER TO GET AN UPDATE OF WHAT'S HAPPENED. AFTER THESE 3 WORKSHOPS HAVE BEEN HELD AND A LOT OF DISCUSSION AMONGst THE WORKING GROUP ABOUT WHAT THEY MIGHT TRY TO FRAME, IT WOULD BE A GREAT OPPORTUNITY HERE AGAIN ABOUT HOW FAR ALONG THE DISCUSSION HAS GOTTEN AND TO GET YOUR FEEDBACK. OKAY. WELL, EVERYBODY, WE'VE DONE PRETTY WELL HERE. IT NOW BEING JUST ABOUT 5:00. YOU HAVE BOUGHT YOURSELF 45 MINUTES OF FREEDOM FOR THE NEXT 45 MINUTES. PLEASE DO EMAILS, MAKE PHONE CALLS, CHAT AMONGST EACH OTHER AND WHATEVER AT 5:45 THERE WILL BE A SHUTTLE BUS THAT WILL PICK YOU ALL UP. IT WILL MEET IN THE B-3 LEVEL OF THIS C WING SO THAT'S WHERE IT WILL. HE WILL WITH HAVE PEOPLE AROUND TO GUIDE YOU DOWN THERE AND THAT WILL TRANSPORT YOU OVER TO THE HOUSE WHERE WE WILL HAVE AN OPPORTUNITY FOR SOMETHING MUCH MORE RELAXED AND INFORMAL THAN THE INTENSITY WE'VE GONE THROUGH ALL DAY, COURTESY OF LARRY AND ROBIN'S HOSPITALITY. AND THEN WE WILL FIND YOU A WAY BACK TO YOUR HOTEL TONIGHT EITHER ON FOOT OR ON VEHICLES DEPENDING ON OYOUR FOOD -- AND WITH THAT WE ARE ADJOURNED UNTIL 9:00 TOMORROW MORNING. THANK YOU ALL.