>>GOOD MORNING EVERYONE WELCOME TO THOSE WHO HAVE COME IN THE ROOM AND THOSE WATCHING BY VIDEO. WE HAVE A VERY FULL AGENDA AND LOTS TO TALK ABOUT AND VERY GRATEFUL TO ALL MEMBERS OF THE COMMITTEE TO HAVE TRAVELED HERE TO SPEND THE NEXT DAY AND A HALF WITH US AS WE SEEK YOUR ADVICE ABOUT A WHOLE HOST OF PRESSING ISSUES. I THINK WE HAVE A REMARKABLE BRAIN TRUST AROUND THE TABLE AND WE'LL NEED TO USE IT BECAUSE WE'RE COUNTING ON MAKING REAL PROGRESS IN THE COURSE OF TODAY AND TOMORROW. JUST A REMINDER OF OUR USUAL LOGISTICAL ITEMS. FIRST OF ALL, YES, FOR MEMBERS OF THE ACD THERE BE COFFEE, JUICE FOR MEMBERS IN THE NEXT ROOM AND GRETCHEN BROUGHT THE JUICE AND I BROUGHT THE STARBUCKS. THERE'S NOTHING ILLEGAL ABOUT THIS, I ASSURE YOU. [COMMENT OFF MIC] >> THESE ARE REAL NEW YORK BAGELS. >> POPPY SEEDS ON THE OUTSIDE. >> DON'T TALK ABOUT POPPY SEEDS. THE MEETING IS. TO THE PUBLIC INCLUDING MEMBERS OF THE PRESS. THE MEETING'S BEING TRANSCRIBED SO WHEN YOU ARE SPEAKING USE THE MICROPHONE SO IT GETS IN THE TRANSCRIPT. YOU HAVE ALL THE MATERIALS YOU SHOULD NEED. AT THE CONCLUSION OF THE MEETING IF YOU DON'T WANT TO SCHLEP THEM HOME WE'LL HAVE THEM MAILED TO YOU. WE'LL TAKE A GROUP PHOTO WHEN WE BREAK FOR LUNCH TODAY PROBABLY IN THAT CORNER BECAUSE THAT'S USUALLY WHERE WE LOCATE OURSELVES FOR THAT. SO PLEASE DON'T RUN OFF UNTIL WE HAVE A CHANCE TO CAPTURE YOU ON CAMERA OR WHATEVER WE CALL DIGITAL STUFF. THERE'S COMMENTS BEHIND TAB 16 I HOPE YOU WILL LOOK AT. MEMBERS OF THE ACD, WE'RE MISSING PETER McLEISCH AND RICK LIFTON INTENDS TO PARTICIPATE BY PHONE SO I SHOULD ASK, RICK, ARE YOU THERE? APPARENTLY NOT YET. IT IS A POIGNANT TIME FOR ME TO ANNOUNCE THE LAST MEETING BECAUSE THESE ARE FOLKS WHO HAVE DEDICATED THEMSELVES TO THIS ENTERPRISE WITH GREAT INGENUITY AND I WAS ASKED ABOUT THE GOLD WATCH. NO, THE BAGEL'S KIND OF IT. ENJOY. IT'S THE GOVERNMENT. THIS IS THE LAST MEETING FOR NO LESS THAN SIX OF OUR ACD MEMBERS. LET ME MENTION THEN AND THEN WE CAN APPLAUD THEM TOGETHER. RUSS ULTMAN HAS BEEN INVOLVED IN MULTIPLE WORKING GROUPS INCLUDING THE GENOME DATA ACCESS AND THE CHILDREN'S STUDY AND THE DATA INFORMATICS. IT WOULD NOT SEEM RIGHT WITH YOU AROUND THE TABLE WITH US BUT WE KNOW WHERE TO FIND YOU. I THINK I HEARD A PHONE. RICK, IS THAT YOU? >> YES, HI. >> WELCOME. I'M GOING THROUGH RECOGNITION OF MEMBERS FOR WHOM THIS IS THE LAST MEETING AND MARY SUE COLEMAN. THE FORMER PRESIDENT OF THE UNIVERSITY OF MICHIGAN AND NOW OF AMERICAN UNIVERSITIES AND ALSO SOMEBODY WHO HAS BEEN A STALWART MEMBER OF THIS GROUP AND AVAILABLE IN HER AAUU ROLE TO CONSULT ON MULTIPLE TOPICS. MUCH GRATITUDE TO YOU. ANN LIPKIN OF COLUMBIA. AND HAS HELPED US ON NOT JUST INFECTIOUS DISEASE ISSUES. I'VE NEVER SEEN ANYBODY GET MORE ENGAGED IN THOSE TOPICS AND WE'LL MISS THAT. PETER McLEISCH IS NOT ABLE TO BE HERE BUT IT WOULD HAVE BEEN HIS LAST MEETING AND HE CONTRIBUTED MUCH TO HIS DISCUSSIONS FROM HIS ROLE AT MOORE HOUSE AND PROFESSOR SERRANO WHO IS A MEMBER OF THE NEXT GENERATION WORKING GROUP WE'LL HEAR ABOUT TOMORROW AND FORMER CO-CHAIR OF THE DIVERSITY WORKING GROUP. AND MICHAEL WELCH FROM THE UNIVERSITY OF IOWA BRINGING HIS WISE ADVICE AND DEEP EXPERTISE IN ACADEMIC MEDICINE TO ALL THE THINGS WE'VE BEEN ENGAGED IN. JOIN ME IN A ROUND OF APPLAUSE FOR ALL SIX OF THOSE DEDICATED MEMBERS. AND LEST YOU FEAR, ACD WOULD UNDERGO A TERRIBLE ATTRITION. WE HAVE A SLATE OF NEW MEMBERS WE VERY MUCH EXPECT WILL BE ABLE TO JOIN US IN JUNE AT THE NEXT MEETING BUT THAT SLATE IS BEING REVIEWED BY THE ACTING SECRETARY BUT AS SOON AS THAT'S HAPPENED WE WILL MAKE NOISE ABOUT THAT AND LOOK FORWARD TO THOSE FOLKS AND FOR THOSE WHOSE NAMES I DIDN'T MENTION, YOU'RE IN IT FOR THE LONGER HAUL. REFLECTIONS. IT'S BEEN AN INTENSE SIX MONTHS SINCE WE LAST MET IN JUNE. I EXPECT INTENSE WHERE YOU ARE AND HERE. SCIENCE CONTINUES AT A TERRIFIC PACE. IF YOU HAVE NOT YET SEEN THIS NEW BROCHURE, NIH, TURNING DISCOVERY INTO HEALTH IS HOT OFF THE PRESS JUST GETTING PUBLISHED LAST WEEK. THIS IS AN UPDATE OF SOMETHING WE PUT TOGETHER, EIGHT YEARS AGO HEN I FIRST BECAME AN NIH DIRECTOR AND PRETTY MUCH COMPLETELY REWROTE IT THANKS TO HELP FROM ALISON AND WENT THROUGH SEVERAL ITERATIONS. IT'S INTENDED FOR A PRETTY BROAD AUDIENCE. IT'S LAVISHLY ILLUSTRATED WITH COLOR PHOTOGRAPHS THAT ARE EYE CATCHING. THERE'S A LOT OF INFORMATION IN HERE. I SUSPECT MANY PEOPLE WON'T SIT DOWN AND READ IT COVER TO COVER. THEY MAY SCAN THROUGH AND PICK OUT THE THINGS THEY'RE INTERESTED IN AND USE IT AS A PREFERENCE. WE INTEND TO USE IT FOR THE VARIOUS CONSTITUENCIES IN KNOWING WHAT NIH IS ALL ABOUT. THE FIRST DISTRIBUTION OF THIS WAS LAST WEEK AT A SENATE HEARING WHERE WE GAVE IT TO EACH OF THE MEMBERS OF THE SENATE HEALTH COMMITTEE THAT WANTED TO HEAR ABOUT THE CURES ACT AND WHERE WE HAVE COME. LOTS OF STUFF TO LOOK AT AT YOUR LEISURE. WHILE I DON'T WANT ANYBODY TO START WORD SMITHING I DON'T THINK THERE'S SPLIT INFINITIVES BUT IF THERE'S SOMETHING YOU THINK WE GOT WRONG BECAUSE WE'LL PROBABLY DO FUTURE PRINTINGS AND WE HAVE A CHANCE TO MAKE CHANGES IF THEY NEED MADE. MAJOR ISSUES IN THE LAST SIX MONTHS WE'LL TALK ABOUT IN THE COURSE OF THE MEETING. LET ME DO A QUICK REVIEW OR PREVIEW OF THE AGENDA. YOU'LL KNOW WHAT'S COMING THOUGH I SUSPECT IT'S FAMILIAR AT THIS POINT. I'M GOING TO TALK FOR A BIT ABOUT A VARIETY OF TOPICS AND UPDATE YOU ON SOME OF THE THINGS THAT WE THOUGHT YOU WOULD WANT TO KNOW ABOUT. WE'LL HAVE TIME FOR DISCUSSION. WE WILL THEN HAVE A BREAK, THOUGH IT MAY NOT SAY THAT ON THE AGENDA AND WE'LL HAVE A BREAK IN THERE SOMEWHERE. THEN DIANA BIANCHI WILL BE ASKED TO DO THE TRADITIONAL DIRECTOR INSTITUTE PRESENTATION WHICH WE HAVE USUALLY DONE AND PROVIDES A CHANCE TO HEAR FROM SOMEBODY LEADING ONE OF OUR 27 INSTITUTES AND CENTERS. AND DIANA AS A NEWBIE BEING BROUGHT RECENTLY AS THE DIRECTOR OF CHILD HEALTH AND HUMAN DEVELOPMENT WILL TALK TO YOU ABOUT WHAT'S HAPPENING FROM HER PERSPECTIVE. THEN WE WILL THEN, AS WE ALWAYS HAVE DONE, HAVE A REPORT FROM THE HE LA WORKING GROUP. LISA COOPER IS GOING TO PRESENT THE FINDINGS ON SEVEN REQUESTS THAT HAVE COME IN SINCE THE LAST ACD MEETING AND WE'LL TAKE A VOTE ON THOSE APPROVALS. WE'LL THEN, AT THAT POINT, TAKE A BREAK FOR LUNCH AGAIN PRECEDED BY THE PHOTOS SO DON'T RUN OFF UNTIL WE GET THE PHOTO AT 1:00. AND HANNAH VALENTIN WILL TALK TO AND WE'LL GET THE MOMENTUM GOING IN OUR EFFORTS IN DIVERSITY. HANNAH IS OUR CHIEF OFFICER FOR SCIENTIFIC WORKFORCE, A ROLE YOU SUGGESTED WE CREATE AND WILL FILL US IN AND THEN OUR DIRECTOR OF EXTRA MURAL WILL PROVIDE AN UPDATE WITH VIGOR AND THE PEER REVIEW WORKING GROUP AND WE'LL TAKE A BREAK AT 3:00. AT 3:15 WE'LL HAVE A PRESENTATION WHICH IS ACTUALLY A DIRECT FOLLOW-UP FROM THE 21st CENTURY CURES ACT WHICH REQUIRED NIH TO HAVE A WORKSHOP AND THEN DEVELOP PLANS ABOUT INCLUSION ACROSS THE LIFE SPAN. SO INCLUDING THE VARIOUS GROUPS WITH CHILDREN AND THE ELDERLY IN TERMS OF WHAT WE'RE DOING TO BE SURE THAT OUR CLINICAL TRIALS MAKE EVERY EFFORT TO INCLUDE ALL PARTICIPANTS WHO MAY WANT TO TAKE PART. DECEMBER 13 WAS THE ONE-YEAR ANNIVERSARY OF THE SIGNING OF THE CURES ACT BY PRESIDENT OBAMA. THIS IS AN ACT WHICH HAS HAD ENORMOUS CONSEQUENCES FOR NIH AND SCIENTIFIC PROJECTS AND POLICY RECOMMENDATIONS WE'RE BENEFIT FROM. AS PART OF THE 21st CENTURY ACT THERE'S FUNDS FOR REGENERATIVE MEDICINE. WE HAVE BEEN WORKING SWIFTLY TO IDENTIFY THE MOST APPROPRIATE WAYS TO UTILIZE THOSE OVER THE FOUR-YEAR PERIOD MADE AVAILABLE BY THE CURES ACT. GARY GIBBONS WILL BE ON THE PHONE BECAUSE HE'S NOT ABLE TO BE HERE IN PERSON. HE'LL INTRODUCE THE TOPIC BASED ON A WORKSHOP WE HELD LAST WEEK WITH FDA ON THE QUESTION ON WHERE THE MOST EXCITING OPPORTUNITIES ARE IN REGENERATIVE MEDICINE AND AMY PATTERSON WILL GIVE THE PRESENTATION. THE ALWAYS MUCH-AWAITED AWARDS WILL BE PRESENTED BY LARRY TAYBACK AND RICK IS OUR MEMBER OF THAT AND WILL BE ASKED TO COMMENT IF HE WISHES TO. THEN WE WILL ADJOURN THE OPEN SESSION AT 4:30 AND GO INTO CLOSED SESSION WHICH WILL HAVE OBVIOUSLY TOPICS WE'LL DISCUSS WITH YOU AT THAT TIME. AND ROUGHLY AROUND 5:15 WE SHOULD CONCLUDE THE CLOSED SESSION. WE WILL AT THAT POINT GIVE YOU A 30-MINUTE BREAK TO MAKE PHONE CALLS OR DO E-MAILS OR WHATEVER IT WAS YOU WOULD NEED TO DO AND THEN WE WILL HAVE A SPECIAL OPPORTUNITY THIS EVENING. WE KEPT YOU IN SUSPENSE. IN THE PAST WE'VE HAD THE OPPORTUNITY FOR ALL OF YOU TO COME TO HOMEMADE DINNER AT THE HOME OF MYSELF OR LARRY TAYBACK OR IN THE PAST, CATHY HUDSON. WE DECIDED TO TRY SOMETHING A LITTLE DIFFERENT. THIS TIME THE DINNER WILL BE HELD SOMEWHAT CLOSER BY AND CAREFULLY ARRANGED BY THE HARD WORK OF MY WIFE, DIAN BAKER AND THE HEAD OF THE CHILDREN'S END BECAUSE WE'RE GOING TO DINNER AT THE CHILDREN'S INN. IF YOU HAVE NOT BEEN THERE BEFORE, I THINK YOU WILL BE AWED BY THE EXPERIENCE WE'LL BE ABLE TO SHOW YOU IN TERMS OF A TOUR. WE'LL HAVE SHUTTLE BUS TO PICK EVERYBODY UP AT 5:45 AT THE SEA WING BECAUSE IT'S KIND OF COLD TO BE WALKING THOUGH IT'S NOT FAR. IT'S RIGHT INSIDE THE SECURITY FENCE AND WE WILL INTRODUCE YOU TO FOLKS AT THE CHILDREN'S INN. WE'LL BREAK UP THE ACD INTO THREE GROUPS AND HAVE A HALF-HOUR TOUR FOR EACH GROUP. YOU'LL HAVE PLENTY OF OPPORTUNITY TO SEE THE FACILITIES WHICH ARE TRULY INSPIRING AND AMAZING AND NO DOUBT YOU'LL BE BUMPING INTO KIDS AND THEIR PARENTS WHO HAVE TURNED UP AFTER LONG DAYS AT THE CLINICAL CENTER. COME BACK TO THE CLINICAL CENTER, WHICH IS THEIR HOME AWAY FROM HOME. AFTER TOURS THEN WE'LL GATHER IN AN APPROPRIATELY SET UP ROOM AND DINNER TOGETHER. SO A LITTLE DIFFERENT VENUE BUT I THINK YOU'LL ENJOY THAT AND WE'LL SOMEHOW FIGURE OUT HOW TO GET YOU BACK TO YOUR HOTEL BEFORE IT GETS TOO LATE. THAT'S WHAT TODAY IS ALL ABOUT. TOMORROW, QUICKLY, WE'LL HAVE A BIG DISCUSSION ABOUT THE NEXT GENERATION RESEARCHERS' INITIATIVE WITH INPUT FROM LARRY AND JOSƒ WHO HAVE BEEN CO-CHAIRING A VERY VIGOROUS WORKING GROUP I HEAR A LOT ABOUT IN TERMS OF THEIR IDEA AND WE WANT TO HEAR FROM YOU. LAURA MORCOV WILL BRING FORTH THE TERRIBLE OPIOIDS CRISIS AND SHE IS THE BEST PERSON TO DO THAT AND LARRY WILL WALK YOU THROUGH A WHOLE HOST OF THINGS THAT ARE UNDERWAY IN TERMS OF HOW TO MAKE GOVERNMENT MORE EFFICIENT, WHICH IS BEING CALLED REIMAGINE, HHS, AND OUR PART OF IT WHICH WE HAVE BEEN ASKED TO LEAVE FORWARD WHICH IS CALLED OPTIMIZE NIH. LARRY HAS BEEN SPENDING MUCH OF HIS TIME EFFECTIVELY PUTTING THAT TOGETHER AND FILL YOU IN ON WHAT THAT LOOKS LIKE AND WHERE WE STAND. THAT IS THE AGENDA YOU'RE IN FOR. AGAIN, I HOPE EVERYBODY WILL BE FULLY ENGAGED IN ALL THIS. WE NEED YOUR INPUT. JUST A LITTLE BIT OF PERSONAL REFLECTION. WE CONTINUE TO BE FORTUNATE IN THIS TIME OF UNPRECEDENTED POLARIZATION AND PARTISANSHIP IN WASHINGTON, MEDICINE SEEMS TO BE A ONE OF THE FEW ISSUES NOT LADEN WITH POLITICAL BAGGAGE. AS THE WONDERFUL TO CONTINUE TO SEE. WE HAVE STRONG SUPPORT FROM THE U.S. CONGRESS. YOU'LL SEE EVIDENCE OF THAT SHORTLY WHEN I WALK THROUGH A NUMBER OF VISITS MEMBERS HAVE MADE TO NIH. I MENTIONED YESTERDAY WAS THE ONE-YEAR ANNIVERSARY OF THE CURES ACT. THAT WAS A REMARKABLE EXAMPLE OF BIPARTISAN SUPPORT. THE HOUSE PASSED THE BILL 392 TO 25 AND THE SENATE THEN PASSED IT 94-5. YOU DON'T SEE A LOT OF THINGS GO THROUGH WITH THAT KIND OF SUPPORT BY LOTS OF CONSULTATIONS AND IT ACHIEVED REMARKABLE SUPPORT. JUST ONE INDICATION, THE CONGRESS CONTINUES TO BE INTERESTED IN HEARING FROM US. I'VE BEEN INVOLVED IN MEETINGS IN THE LAST TWO WEEKS, LOTS OF TIME DOWN ON THE HILL AND IT'S ALWAYS WELCOME TO HAVE A CHANCE TO DO THAT IN SOME INSTANCES. SITTING NEXT TO OTHER GOVERNMENT MEMBERS SUCH AS SCOTT GOTTLIEB OF FDA BECAUSE MANY ARE CONCERNED WITH HOW THE CURES ACT WITH PROVISIONS AND THEY WERE GRATIFIED BY THE RESULTS ACHIEVED ALREADY IN JUST A CHEER. TWO OF THE OTHER EVENTS WERE -- ACHIEVED ALREADY IN JUST A YEAR AND THE TWO OTHER EVENTS ARE ON OPIOIDS AND SPENDING TIME WITH THE HEAD OF SAMIS A -- SAMSA WHO OVERSEE THE CURES ACT TO SUPPLY BETTER RESOURCES FOR TREATMENT OF INDIVIDUALS SUFFERING FROM ADDICTION. AND LOTS OF SHOULDER RUBBING WITH CDC ABOUT THE WHOLE ISSUE OF OPIOID ADDICTION. IT'S ALSO FAIR TO SAY THE ADMINISTRATION HAS BEEN DEVELOPING INCREASING INTEREST AND ENTHUSIASM. LOTS OF CONVERSATIONS HAVE GONE OVER THE MONTHS IN THAT REGARD. CERTAIN MEMBERS OF THE ADMINISTRATION WOULD ADMIT THEY'RE OFF TO A ROUGH START BUT THIS IS A TIME WHERE THINGS ARE LOOK MORE PROMISING IN CONSIDERATION FOR WHY THIS IS AN IMPORTANT ROLE FOR INVESTMENT BY THE FEDERAL GOVERNMENT. THAT'S ALL GOOD. AS YOU HEAR SHORTLY WHEN I GET NEIL AND ADRIAN TO TELL YOU WHERE WE ARE WITH BUDGETS AND LEGISLATIVE ISSUES, WE ARE ONCE AGAIN, IN THE MIDST OF UNCERTAINTY. WE'RE LIVING UNDER A CONTINUING RESOLUTION. THE FIRST CONTINUING RESOLUTION CARRIED US THROUGH TO DECEMBER 8, BUT IT WAS NOT POSSIBLE GET A BUDGET TOGETHER FOR FY18 AND WE'RE UNDER THE SECOND CONTINUING RESOLUTION EXPIRING A WEEK FROM TOMORROW ON DECEMBER 22. AND I THINK IT IS HIGHLY UNLIKELY THAT WE WILL ACTUALLY HAVE AN OMNIBUS APPROPRIATION FOR THE ENTIRE GOVERNMENT BY TOMORROW GIVEN THE NUMBER OF STEPS AND THE DISTRACTIONS ON THE HILL INCLUDING THE TAX REFORM DISCUSSIONS. IT SEEMS ALMOST CERTAIN THAT EITHER WE'LL HAVE A SHUT DOWN -- BUT I HOPE NOT AND I DON'T THINK IT'S VERY LIKELY THAT WE WILL, BUT YOU ALWAYS CROSS YOUR FINGERS, MORE LIKELY THERE'LL BE ANOTHER CR TO CARRY US THROUGH TO SOME TIME IN THE FIRST OF THE YEAR. I KNOW ADRIAN HAS HER EAR TO THE GROUND AND CAN MAYBE GIVE US NEWS WHAT THAT MIGHT LOOK LIKE. AGAIN, I GOT TO SAY IT IS NOT AN EASY TASK TO TRY TO MANAGE A $34 BILLION A YEAR ENTERPRISE WHEN YOU DON'T KNOW NOW THREE MONTHS IN THE FISCAL YEAR WHAT YOUR RESOURCES ARE GOING TO BE. EVEN IN THE BEST OF CIRCUMSTANCES, WE ONLY KNOW ONE YEAR AT A TIME WHAT IS LIKELY TO BE THE CASE BUT IT IS OUR SYSTEM AND AGAIN I CAN'T SAY ENOUGH ABOUT HOW THE ENTHUSIASM FOR MEDICAL IS A SOURCE OF ENCOURAGEMENT BECAUSE IT IS AND IF YOU LISTENED IN TO THE HEARINGS WE HAD IN THE LAST WEEKS AND THE STRONG STATEMENTS OF SUPPORT FROM BOTH PARTIES IN BOTH HOUSES WOULD HAVE REASSURED YOU WE ARE IN A POSITION OF BEING SEEN AS CONTRIBUTING LOTS OF VALUE. SO I'LL COME TO IN A MOMENT SOME SPECIFIC EXAMPLES OF EVENT HAVE HAPPENED HERE. FIRST, LET ME SAY SOMETHING ABOUT NIH LEADERSHIP. FIRST, I HAVE TO STAY I AM TRULY FORTUNATE AT THIS MOMENT TO BE SURROUNDED BY SUCH INCREDIBLY DEDICATED FOLKS WITH SUCH CAPABLE ABILITY TO MANAGE A WIDE VARIETY OF CHALLENGES AND WILLING TO PUT IN INCREDIBLE TIME COMMITMENTS AT A TIME WHEN NO ONE WORKS A 40-HOUR WEEK AND USUALLY AN 80-HOUR WEEK AND SOMETIMES MORE THAN THAT AND LARRY TAYBACK SHOULDERS A WHOLE LOT OF TRULY CHALLENGING ISSUES DAY AFTER DAY. IF THERE'S A CRISIS, HE'S THE FIRST GUY TO FIND OUT ABOUT IT AND KNOW WHAT TO DO ABOUT IT. MOST HAPPEN FRIDAY AT 5:30 BUT OCCASIONALLY WE HAVE THEM AT OTHER TIMES. AS YOU WILL HEAR, HIS LEADERSHIP IN OTHER WAYS WITH RE-IMAGINE AND THE NEXT GENERATION WORKING GROUP IS IMPORTANT. AND CARRY WOLINETZ AS MY ACTING CHIEF OF STAFF BRINGING A GREAT DEAL OF SKILL TO THOSE ROLES KEEPING THINGS MOVING ALONG IN WAYS THAT JUST MAY NOT HAPPEN AND THE HEAD OF THE EXTRA MURAL DIVISION AND MIKE GOTTSMAN AND OTHERS WHO HAVE JOINED US AND WHOM I CAN'T THANK ENOUGH. AND A BIG THANKS TO GRETCHEN WHO HAS SERVED MANY YEARS AS THE PERSON TO PUT TOGETHER THE DETAILS OF THE ACD MEETINGS AND HAS DONE IT AGAIN TO MAKE IT POSSIBLE FOR ALL THE INFORMATION THAT YOU NEED TO BE IN FRONT OF YOU AND FOR HOPEFULLY US TO GET THE MOST OF THIS GATHERING. THERE ARE, OF COURSE, WITH 27 INSTITUTES AND CENTERS A REGULAR TURNOVER THAT HAPPENS. THE USUAL AVERAGE DWELL TIME FOR AN INSTITUTE CENTER DIRECTOR IS IN THE NEIGHBORHOOD OF EIGHT TO TEN YEARS. WITH 27 MUCH THEM, MOST THE TIME WE'RE SEEING THINGS HAPPEN THAT REQUIRE US TO SAY THANK YOU AND SET UP SEARCH COMMITTEES. FIRST, FOR AN ARRIVAL, A VERY BIG AND IMPORTANT ONE THOUGH HE'S NOT HERE THIS MORNING AND THAT WAS THE ARRIVAL OF NED SHARPLESS OF THE DIRECTOR OF THE NATIONAL CANCER INSTITUTE. RECRUITED FROM THE UNIVERSITY OF NORTH CAROLINA WHERE HE WAS DIRECTOR OF THEIR CANCER CENTER AND A DISTINGUISHED DIRECTOR OF CANCER RESEARCH AND BRINGS ENORMOUS SKILL AND CAPABILITIES AND KNOWS HIS FIELD AND THIS COMMUNITY EXTREMELY WELL AND IS A VISIONARY AND SOMEBODY WHOSE OWN RESEARCH HAS BEEN GROUNDBREAKING WITH CANCER AND AGING. IT'S BEEN WONDERFUL TO HAVE HIM ARRIVE. HE WAS ANNOUNCED BACK IN THE SUMMER. THEN A LONG PERIOD BEFORE WE GOT SWORN IN WHICH HE DESCRIBES AS THE WORST VACATION OF HIS LIFE BECAUSE HE PUT HIMSELF IN A LITTLE APARTMENT IN WOODLEY PARK AND WASN'T ALLOWED TO DO ANYTHING AND NOW HAS BEEN SWORN IN. YOU'LL SEE HIM TOMORROW MORNING AND AT THAT TIME HAVE A CHANCE TO SAY HELLO. DOUG LOWEY HAS ACTED BRILLIANTLY AND HAS AGREED, GRACIOUSLY, TO STAY ON UNDER NED'S DIRECTION. THAT'S AN ARRIVAL. AND WE HAVE FOLKS WHO HAVE RECENTLY MOVED ON TO OTHER THINGS. ONE OF THEM AND BOTH WILL BE PEOPLE MUCH MISSED. JOSIE BRIGGS WHO DECIDED TO STEP DOWN AS THE DIRECTOR OF THE NATIONAL CENTER FOR INTEGRATIVE AND COMPLEMENTALLY HEALTH TO BE THE EDITOR-IN-CHIEF TO THE JOURNAL OF NEPHROLOGY. HE HAS BEEN AN IMPORTANT MEMBER FOR 20 YEARS AND SHE TOOK A BRIEF AND ILL-CONCEIVED VENTURE INTO HHMI AND CAME BACK AS THE DIRECTOR OF NCCIH AND HAS BEEN ASKED BY ME AND OTHERS ON PNEUM RECOGNIZE OCCASION TO TAKE MULTIPLE OTHER ROLES WHICH SHE HAS DONE WITH GREAT SKILL. FOLLOWING JOSIE'S DEPARTURE, SIX WEEKS AGO AND WHILE WE CONDUCT A NEW SEARCH, WE HAVE AN ACTING DIRECTOR. WE'RE GRATEFUL FOR THAT ROLE. THE OTHER DEPARTURE IS RODERICK PETTIGREW THE ONLY SO FAR DIRECTOR OF BIOMEDICAL ENGINEERING WHO PUT THE ENTIRE INSTITUTE ON THE MAP AS A VERY SUCCESSFUL ENTERPRISE WITH PARTICULAR FOCUS ON INNOVATIVE TECHNOLOGIES. RODERICK WAS ALWAYS FOND TO POINT OUT IF YOU LOOK AT PATENT APPLICATIONS THEY'RE HEAD AND SHOULDERS ABOVE. AND HAS BECOME THE CHIEF EXECUTIVE OFFICER OF A NEW PROGRAM BRAND NEW HEALTH AND ENGINEERING TO INTEGRATE ENGINEERING TO ALL TEXAS A&M COLLEGES IN HOUSTON AND HE'LL BE THE EXECUTIVE DEAN OF A NEW HOUSTON-BASED ENGINEERING MEDICINE TRACK CALLED INMED TO HAVE STUDENTS INVENT SOLUTIONS FOR CHALLENGING MEDICAL PROBLEMS BRINGING TOGETHER HIS EXPERTISE IN THIS FIELD. AS A PARTNERSHIP WITH HOUSTON METHODIST HOSPITAL AND TEXAS A&M AND HE'LL BE AN ENDOWED CHAIR AT THE COLLEGE OF MEDICINE AT TEXAS A&M. WE'RE GRIEVING HIS DEPARTURE BECAUSE HE'S CONTRIBUTED SO MUCH DURING HIS 15 YEARS BUT UNDERSTAND WHAT A REMARKABLE OPPORTUNITY THIS IS. AND FOLLOWING HIS DEPARTURE AND WHILE WE CONDUCT A NATIONAL CHURCH DR. GRENCHURCH WILL BE ACTING AND WE APPRECIATE HER WILLING TO DO SO DURING THE TRANSITION. SO THOSE ARE PERSONNEL THINGS. I CAN GIVE YOU A LONG LIST OF EVENTS THAT HAVE HAPPENED BUT I THOUGHT MAYBE WE'D ILLUSTRATE THEM WITH PHOTOGRAPHS HERE. I'M GOING TO RUN THROUGH A LITTLE PHOTO MONTAGE OF THINGS PLUCKED OUT OF THE LONG LIST. THIS IS CERTAINLY NOT THE COMPLETE STORY BUT JUST TO GIVE YOU A SENSE OF SOME OF THE THINGS THAT HAVE HAPPENED HERE SINCE WE LAST MET. AGAIN, SCIENCE ADVANCES, THE THING WE'RE MOST EXCITED ABOUT, I JUST ASKED JOHN BERKELOW TO PICK THINGS THAT HAVE LED TO PRESS RELEASES, MOST IN RESEARCH DONE IN INSTITUTIONS ALL OVER THE COUNTRY BUT SUPPORTED BY NIH WITH A WIDE VARIETY OF APPLICATIONS. DON'T MAKE MUCH ABOUT WHICH WE PICKED WE COULD HAVE PICKED ANY SET AND THEY WOULD HAVE BEEN EQUALLY AS EXCITING. AND I HOPE THIS IS NOT NEWS TO YOU, I'VE BEEN TRYING OVER THE COURSE NOW OF FIVE YEARS, EVERY TUESDAY AT EVERY THURSDAY TO PUT SOMETHING UP THERE THAT COULD BE OF USE TO THE GENERAL PUBLIC, PARTICULARLY TO STUDENTS ABOUT WHAT'S GOING ON IN SCIENCE AND THIS IS A BLOG. ON TUESDAY I USUALLY PICK SOMETHING THAT'S BEEN PUBLISHED IN THE LAST WEEK OR SO AND WRITE A FEW PARAGRAPHS ABOUT IT AND ON THURSDAYS WE OFTEN HAVE A PORTRAIT OF A PARTICULAR INVESTIGATOR DOING SOMETHING EXCITING LIKE YOU CAN SEE IN THE LOWER RIGHT THERE WITH AN INVESTIGATOR WITH A CRISPER GENE DRIVE AND WE HAVE VIDEOS OR STILL PHOTOS THAT COME OUT OF IMAGINING WHICH ARE EYE-CATCHING AND THIS DOES NOW, OVER THE COURSE OF THE LAST FOUR OR FIVE YEARS, BEEN SEEN BY A MILLION INDIVIDUALS AND GETS TENS OF THOUSAND OF HITS EVERY TIME WE PUT ONE UP AND HOPEFULLY THAT'S DOING US SERVICE IN TERMS OF INFORMATION. I'M ALSO A REGULAR USER OF TWITTER AND THIS WEEK HIT 80,000 FOLLOWERS AND TRIED TO USE THAT MECHANISM AS WELL, NOT FOR POLITICAL REASONS, JUST TO TALK ABOUT SCIENCE. THAT'S WHAT WE DO HERE. ANYWAY, IF YOU HAVEN'T ALREADY GOTTEN THE BLOG FEED GO TO THE NIH SITE AND GET SIGNED UP TO GET THOSE WHEN WE TWEET EVERY TUESDAY AND THURSDAY. NOW, AS TO VISITORS, MEMBERS OF CONGRESS, WE'VE HAD QUITE AN INTERESTING TIME. I'LL DO THIS IN CHRONOLOGICAL ORDER SINCE YOU LAST GATHERED HERE. THIS IS THE HOUSE NEW DEMOCRAT FOUR MEMBERS WHO CAME OUT AND SPENT SEVERAL HOURS WITH US LED BY SCOTT PETERS WHO IS THE DEMOCRAT FROM SAN DIEGO ON THE LEFT WITH OTHER MEMBERS. WE LOVE WHEN MEMBERS COME OUT. WE HAVE A CHANCE WITHOUT BEING A VOTE AND SHOW THEM THING AND THE CLINICAL CENTER AND GET TO MEET THE INVESTIGATORS AND THE PATIENT IN THE MIDST OF A CLINICAL TRIAL. TEY'RE TRANSFORMATIVE. I KNOW YOU ALL AGREE WITH THAT AND I HOPE THIS PARTICULAR MOMENT IS WHEN YOU REACH OUT TO ELECTED MEMBERS AND ENCOURAGE THEM TO COME BY AND CHECK OUT THEIR OWN INSTITUTIONS IN THEIR OWN STATE. NEWT GINGRICH VISITED US IN JUNE AND INTERESTED IN STEM CELLS AND ALZHEIMER'S DISEASE. I HAVE QUITE A TUTORIAL ON THAT DAY. CENTER CHRIS KOONCE HAS BECOME A BIG FAN AND THEY'VE PARTICULARLY INTERESTED IN THE TECHNOLOGY AND HAS BEEN OUT TO MCATS AND LOOKED AT WHAT WE'RE DOING IN TERMS OF SMALL MOLECULES, THIS INSTANCE WANTED TO HEAR SPECIFICALLY ABOUT ALZHEIMER'S DISEASE AND YOU SEE THEM TALKING ABOUT NEUROLOGICAL CONDITIONS. JERRY HAS GOTTEN HIMSELF EXTREMELY WELL EDUCATED ABOUT BIOMEDICAL RESEARCH ISSUES AND IS A STRONG POSITIVE VOICE IN VARIOUS COMMITTEES HE SERVES ON. THE CONSIDERATION BLACK CAUCUS CAME TO SEE US. EIGHT OR NINE OF THEIR MEMBERS AND SPENT A VERY INTERESTING MORNING AS WE WALKED THEM AROUND TO LOOK AT WHAT'S GOING ON IN AREAS SUCH AS IMAGING, SICKLE CELL DISEASE RESEARCH AND WHAT WE'RE DOING IN A VARIETY OF ISSUES ABOUT HEALTH DISPARITIES AND WORKFORCE TRAINING. SEE FIVE OF THEM IN THE FRONT WITH US AND A WONDERFUL VISIT I THINK BUILT A LOT OF CONFIDENCE IN WHAT WE'RE DOING IN THIS IMPORTANT AND INFLUENTIAL GROUP LED BY BARBARA LEE IN THE MIDDLE THERE. THE PICTURE INCLUDES SOME OF THE TRAINEES. THAT'S THE OTHER THING WE DO THAT MAKES A DIFFERENCE. THEY'RE EXCITED TO SEE INVESTIGATORS, BUT WHEN THEY GET A CHANCE TO SEE YOUNG SCIENTISTS IN TRAINING THEY GET REALLY EXCITED AND THEY SHOULD. OFTEN TIMES IT'S THE BEST PART OF THE VISIT. WE'VE ALSO GOT VISITS THE EXECUTIVE BRANCH AND JOHN BARTIS CAME OUT TO SEE US IN JULY. YOU MAY NOT RECOGNIZE THESE PARTICULAR PICTURES AS PART OF NIH BUT THEY ARE. WE HAVE ONE OF THE MOST ADVANCED UTILITY PLANS AND HE WAS BLOWN AWAY TO FIND OUT NIH HAS THIS ENGINEERING CAPABILITY AND WENT AWAY SAYING WE SHOULD JUST RUN THE REST OF THE DEPARTMENT BECAUSE WE'RE SO EFFICIENT. WE DECIDED TO DECLINE THAT WONDERFUL OFFER. THE ASSOCIATE DIRECTOR OF OMB, WITH THE BEARD, CAME OUT TO VISIT US AND THE OFFICE OF MANAGEMENT AND BUDGET IS AN IMPORTANT PART OF THE WHITE HOUSE SINCE THEY HAVE A BIG ROLE IN DECIDING WHERE THE MONEY GOES. AND WE HAVE MORE AND TOM PRICE CAME TO SEE WHAT WAS GOING ON IN THE VACCINE RESEARCH CENTER AND GOT A VERY DID TOUR ON WHAT'S GOING ON AND TONY FULCIH CAME AWAY INSPIRED AND WE HAD ALL THE INSTITUTE DIRECTORS WHO HAD A TOUR IN THIS CASE FOCUSSED, AS YOU MIGHT IMAGINE, ON INFECTIOUS DISEASES, AND WHAT WE NEED TO DO IN THIS ALWAYS CHALLENGING SPACE. THE CURRENT ACTING HHS SECRETARY, ERIC HARGEN CAME OUT TO VISIT US AND HE'S LEARNING ABOUT THE LAYOUT OF THE CLINICAL CENTER. WE HAD A BIG DISCUSSION WITH MULTIPLE OTHER INSTITUTE DIRECTORS AND SPENDING A LOT OF TIME WITH ACTING SECRETARY HARGAN IN HIS ROLE NOW KEEPING THE GOALS AND IDEAS AND DREAMS OF NIH VERY MUCH IN FRONT OF HIM AND HE'S BEEN A WONDERFUL SUPPORTIVE INFLUENCE ON EVERYTHING WE'RE TRYING TO DO. AWARDS HAVE ALSO HAPPENED. THE BIG ONE THAT WENT TO OUR INTRAMURAL INVESTIGATORS THAT DID WORK WITH THE HPV VACCINE. THAT'S A HAPPY OCCASION IN NEW YORK. I DIDN'T PUT IN A SLIDE BUT I COULD HAVE ABOUT THE NOBEL PRIZES BECAUSE WE DID VERY WELL THIS YEAR WITH THE AWARDEES BOTH IN CHEMISTRY AND MEDICINE, PHYSIOLOGY HAVING NIH SUPPORT IN A SUBSTANTIAL WAY AND BEING QUITE HAPPY TO POINT THAT OUT. ANOTHER AWARD I WANTED TO MENTION, MANY OF YOU KNOW ABOUT THE FOUNDATION FOR NIH AS A NONPROFIT TO MAKE IT POSSIBLE TO DO THINGS SUCH AS THE ACCELERATED MEDICINE PARTNERSHIP AND SOME THINGS GOING ON IN THAT SPACE. MARIA FRAEER WHO HAS BEEN PRESIDENT THERE FOR THREE OR FOUR YEARS, WAS RECOGNIZED IN A DOUBLE WHAMMY IN NEW YORK IN THE BIGGEST AWARD PROGRAM FOR NONPROFITS. NOT ONLY DID FNIH WIN, MARIA WON THE GOLD FOR WOMAN OF THE YEAR WHICH IS PRETTY UNPRECEDENTED. WE'RE REALLY FORTUNATE TO HAVE FNIH AS A PARTNER. AND THERE'S RANDOM FUN EVENTS. WE HAD THIS ON JUNE 13 FOR AN INTERESTING DISCUSSION IN FRONT OF A PACKED AUDIENCE ABOUT HIS OBSERVATION ABOUT THE STATE OF HEALTH CARE AND MANY ARE FAMILIAR WITH HIS BOOKS AND WRITINGS AND THAT WAS FASCINATING AND HE VISITED WITH FOLKS WHILE HERE. ROGER AND I WERE HAPPY TO MEET WITH THE NEW DIRECTOR OF WHO, WHOSE NAME IS NOT PRONOUNCEABLE WE CALL TEDROS AND RESPONDS TO THAT AND GREAT TO HAVE HUM -- HIM IN THE ROLE OF WHO DIRECTOR. YOU PROBABLY HEARD OF U-2, THE BAND, AND MAYBE HEARD OF THEIR AMAZING GUITAR PLAYER WHOSE NAME IS DAVID, BUT GOES BY "THE EDGE" IF YOU'RE FAMILIAR AT ALL, THAT'S WHAT YOU HAVE TO CALL HIM. HE'S AN ADVOCATE FOR CANCER RESEARCH AND PARTICULARLY SOMEBODY WHO ADVISES THE ANDROGENSIS DIRECTOR. U-2 WAS GIVING A CONCERT AT FEDEX FIELD AND WE GOT HOLD OF THE EDGE AND ASKED IF THERE WAS A CHANCE TO TALK ABOUT SCIENCE AND OH, YEAH, PLAY A LITTLE MUSIC WHICH HAPPENED IN SOME OFFICE BUILDING IN DOWNTOWN D.C. NOT THE GREATEST VENUE. THEN MORE IMPORTANTLY THE NEXT DAY, ME INVITED FOUR PATIENTS TO BE HIS GUEST. YOU CAN SEE THEM GATHERED IN THE ROOM OFF STAGE FOR THE OFFICIAL PHOTOGRAPH WITH "THE EDGE." THESE FOUR INDIVIDUALS HAVE VERY SIGNIFICANT CHALLENGES. THREE OF THE FOUR OF THEM HAVE RARE CANCERS. THEY'RE UNDER CARE OF THE DOCTORS AND SPENT MANY NIGHTS AT THE CHILDREN'S INN AND EVEN BROUGHT THEM ON STABLE. THIS IS FEDEX FIELD, AND BROUGHT THEM ON STAGE. I'M SURE IT WILL NEVER BE FORGOTTEN BY THEM AND CERTAINLY WON'T BE ON ME. SO A VERY SPECIAL DAY WITH A SPECIAL GUY. OTHER VISITORS, WE'LL TALK ABOUT THE LATEST REVIEWS OF THE HE LA WORKING GROUP AND THE ACCESS TO GENOME SEQUENCE. WE HAD AN INTERESTING AND WELL-ATTENDED SESSION AT THE MAIN AUDITORIUM AT NIH TO TALK ABOUT WHERE THIS ALL COMES FROM AND WE'RE FORTUNATE TO HAVE DAVID LAX AND GRANDCHILDREN FROM -- HER. AND I'M SURE YOU HAD A CHANCE, THOUGH IT WOULD HAVE TAKEN ABOUT SIX HOURS, TO WATCH THE FIRST OF HUMAN. AN AMAZING DOCUMENTARY PUT OUT BY THE DISCOVERY CHANNEL WHEN IT CAME OUT IN AUGUST. WE HAD AN OPPORTUNITY TO BRING THE PRODUCER, JOHN HOFFMAN RIGHT HERE, TO NIH FOR HIS SPECIAL PROGRAM ABOUT THIS ALONG WITH SOME OF THE DOCS FEATURED THERE. YOU CAN SEE IN THE PHOTOGRAPH AS PART OF THE FILM. THIS IS STILL OUT STREAMING. IF YOU MISSED IT SOMEHOW, THIS WOULD BE A GREAT THING TO PUT ON YOUR LIST OF THINGS TO DO. INCREDIBLY POWERFUL VIDEO FOLLOWING FOUR INDIVIDUALS AND THEIR FAMILIES WHO CAME TO THE CLINICAL CENTER FOR TREATMENT IN EXTREMELY DIFFICULT CIRCUMSTANCES AND WALKED THROUGH OVER THE COURSE OF A COUPLE YEARS, THOUSAND OF HOURS OF FILMING AND TURNED INTO THIS SPECIAL. IT IS MOVING. IT IS AT TIMES HARD TO WORK BECAUSE NOT EVERYBODY HAS A HAPPY ENDING BUT THAT'S THE NATURE OF IT. I THINK THIS TAUGHT PEOPLE THE REALITIES OF WHAT WE'RE TRYING TO DO RIGHT ON THE LEADING EDGE IN A WAY THAT FEW PROGRAMS HAVE NEVER ACHIEVED. WE HAD THE FORMER SURGEON GENERAL COME OUT IN SEPTEMBER TO TALK ABOUT HIS OBSERVATIONS AS SURGEON GENERAL ABOUT THE STATE OF THE NATION AND PARTICULARLY CONCERN HE SEES ON STRESS AND A SENSE OF ISOLATION. HE'S WRITTEN ARTICULATELY ABOUT THAT AND CONTINUES IN HIS ROLE NOW TO SPREAD THE WORD ABOUT SOME OF THESE ISSUES AND WHAT WE MIGHT DO ABOUT THEM. IT WAS AN IMPRESSIVE CONVERSATION. THIS WAS A SPECIAL LECTURE NAMED FOR STEVEN STRAUSS WHO WAS PREVIOUSLY THE DIRECTOR OF THE NATIONAL CENTER FOR COMPLIMENTARY AND ALTERNATIVE MEDICINE WHO'S LEGACY INCLUDES THE LECTURE TO ENCOURAGE PEOPLE TO THINK ABOUT WAYS IN WHICH WHAT'S HAPPENING AROUND YOU EVEN MORE THAN WE MIGHT REALIZE HAS A BIG IMPACT. CONTINUING OUR TRADITIONAL OF WORKING CLOSELY WITH NSF, PATTY BRENNAN WOULD YOU SEE IN THE PHOTOGRAPH HERE, THE DIRECTOR OF THE NATIONAL LIBRARY OF MEDICINE, INVITED THE DIRECTOR OF NSF TO DELIVER THE KING LINDBERG LECTURE AT NLM AND THAT WAS A GREAT EXPERIENCE PUTTING OUR PARTICULAR INSTITUTIONS TOGETHER. PATTY IS RIGHT HERE. THANK YOU FOR ORGANIZING THAT. OTHER THING WE CONTINUE TO DO AS A COLLABORATION WITH THE NATIONAL SYMPHONY OCCUR -- ORCHESTRA THEY SET UP AND PUT ON AN HOUR OF AMAZING MUSIC. YOU WOULD THINK THE ACOUSTICS WOULDN'T BE SO GOOD BUT THEY'RE EXCELLENT. IT'S INSPIRING WHEN THEY START PLAYING AND I'M SITTING THERE LOOKING UP. THIS IS THE OPEN ATRIUM AND YOU CAN SEE SEVEN FLOORS UP AND PEOPLE ARE GATHERING OR TAKING A BREAK FROM WHATEVER ELSE IS HAPPENING AND LISTENING TO WHAT IS BEING PUT FORWARD BY AN AMAZING BUNCH OF MUSICIANS. SEVERAL TIMES A YEAR, SUBSETS THEY BRING THE BRASS QUINTET OR STRING QUARTETTE AND LET US STEP AWAY FROM THE INTENSITIES OF WHAT'S GOING ON. WE CONTINUE TO WORK WITH THE KENNEDY CENTER IN A PROGRAM ON MUSIC AND THE MIND WHICH HAS BEEN FASCINATING TO BE ABLE TO EXPLORE. I THINK LAST TIME YOU WERE ALL HERE, WE JUST HAD A SPECIAL DAY AND A HALF AT THE KENNEDY CENTER WITH A WIDE VARIETY OF PRESENTATION S THAT RELATE TO THE NEUROSCIENCE AND HOW WE CAN LEARN HOW TO MAKE MUSIC THERAPY WHICH IS LARGELY AN APPROACH INTO SOMETHING WITH A STRONGER SCIENCE BASE. THAT CONNECTION CONTINUES TO BE STRONG. THE WORKING GROUP AT NIH CO-LED BY BOB FINKELSTEIN AND EMILY EDWARDS IN WHAT WOULD BE NEW RESEARCH OPPORTUNITIES TO FURTHER EXPLORE MUSIC AND NEUROSCIENCE. I THINK THERE'LL BE SOME THINGS COMING OUT OF THAT. I'LL BE DOWNTOW LATE IN THE KENNEDY CENTER FOR ANOTHER EFFORT BETWEEN THE NIH AND THE KENNEDY CENTER WHICH HAS BEEN INTERESTING TO BE PART OF AND HAS TAKEN LOTS OF TIME AND EFFORT FROM THE NOTABLE SOPRANO, NICOLE FLEMING, WHO IS ENGAGED ALONG WITH THE HEAD OF THE KENNEDY CENTER. IT'S A DUTCH -- DIFFERENT WAY TO SPEND ONE'S TIME. THIS IS OCTOBER 12 AT THE PRESS CLUB WHERE WE ARE ANNOUNCING THE FORMATION OF A NEW PUBLIC/PRIVATE PARTNERSHIP WHICH IS THE PARTNERSHIP FOR ACCELERATING CANCER THERAPIES. THIS IS THE RESULT OF MORE THAN A YEAR OF HARD WORK IDENTIFYING AREAS WHERE INDUSTRY AND NIH AND ADVOCATES AND THE FDA CAN WORK TOGETHER IN ORDER TO SPEED UP THE PROCESS OF IDENTIFYING WAYS FOR CANCER IMMUNOTHERAPY TO GO FASTER. WE'RE EXCITED ABOUT THIS BUT THERE'S A LOTS OF THINGS WE DON'T KNOW. PARTICULARLY, WHY IT WHEN IT WORKS AND WHY DOES IT NOT WORK WHEN IT DOESN'T? EVERYBODY AGREES IDENTIFYING BIOMARKERS WOULD BE VALUABLE BUT NO SINGLE COMPANY IS SET UP. NIH IS INTERESTED BUT WE CAN DO IT FASTER WITH COMPANY PARTS PACE -- PARTICIPATION. AND ON THAT DAY 12 COMPANIES AGREED TO JOIN WITH PUTTING SIGNIFICANT FUNDS BEHIND THE PROGRAM AND THERE IS DOUG LOWEY BEFORE NED GOT SWORN IN AND TOM HUDSON REPRESENTING INDUSTRY AND REED CORDISH AND JOHN BERKELOW AND YEAH, ME. WE HAD A GOOD DAY IN DESCRIBING HOW THIS KIND OF ENTERPRISE CAN SPEED UP THE PROCESS OF IMMUNOTHERAPY TO BENEFIT MORE AND MORE PEOPLE. THAT SAME DAY, BECAUSE IT WAS NOT A SLOW DAY, WE HAD AN INTERESTING AND ENJOYABLE TIME HOSTING THREE OF CONGRESSMAN STOKE'S KIDS. CONGRESSMAN STOKES, WHO DIED A COUPLE YEARS AGO. WAS A MEMBER OF CONGRESS WHO IS LEGENDARY BOTH BECAUSE OF HIS STRONG INTEREST IN MEDICAL RESEARCH AND HIS STRONG ABILITY TO ENCOURAGE ALL OF US TO THINK ABOUT HEALTH DISPARITIES AND PUT EVERY BIT OF THE POWER OF NIH TO UNDERSTAND THE CAUSES AND SOLUTION. I GOT TO KNOW CONGRESSMAN STOKES QUITE WELL AND SAT AT A WITNESS TABLE WHERE HE COULD MAKE ME SQUIRM. HE WAS A REMARKABLE LEAD AND GENTLE ONE THROUGH ALL THIS. A BUILDING WHERE MY LABORATORY IS CURRENTLY HOUSED IS ALSO THE STOKES BUILDING NAMED AFTER HIM. THIS EVENT WAS HELD IN THE STOKES BUILDING TO HEAR MORE OF FROM HIS FAMILY IN CONCERT WITH THE BOOK DESCRIBING THE GENTLEMAN FROM OHIO. THEN THIS IS NOT AT NIH BUT I THREW IT IN. IN OCTOBER THE AMERICAN SITE OF GENETICS DECIDED TO HAVE AS PART OF THEIR SYMPOSIUM TWO SPEAKERS TO HAVE A CONVERSATION, MYSELF AND BILL GATES. BILL WANTED TO USE THE OCCASION OF GOING TO ORLANDO TO HAVE A TUTORIAL ABOUT THINGS HE WANTED TO LEARN ABOUT HUMAN GENETICS. SO THE SESSION IS ON EPIGENOMICS AND WHAT IS HAPPENING WITH STEM CELL AND SICKLE CELL DISEASE. AND ALZHEIMER'S. BRIEFING BILL GATES IS AN EXPERIENCE. HE'S GOT A SHARP MIND AND HE'S ALREADY DONE A LOT OF HOMEWORK BEFORE HE COMES TO THE ROOM AND YOU DON'T WANT TO INSULT HIM AND WE HAD ASSISTANT PROFESSORS AND I THINK HE CAME AWAY INSPIRED AND ANNOUNCED NOT LONG AFTER THAT A MAJOR DONATION TO ALZHEIMER'S DISEASE RESEARCH OF WHICH HE WAS CLEARLY THINKING ABOUT DURING THE COURSE OF OUR CONVERSATION. THAT WAS A SPECIAL AFTERNOON. THIS WAS ALSO A SOMEWHAT SILLY AND ENJOYABLE EVENING THAT CAME AFTER THAT. NOT ONLY DID I HAVE A CHANCE TO BE ON STAGE WITH BILL, I HAD A CHANCE TO BE PART OF THE BAND THAT PLAYED AT HE RECEPTION AND THE BAND AND WE ROCKED THE HOUSE. WE CONTINUE TO WORK WITH THE GATES FOUNDATION IN THE GLOBAL HEALTH AREAS WE CONTINUE TO TALK ABOUT BEFORE AND HAVE ANNUAL MEETINGS WITH BILL AND HIS TEAM. I THINK THE LAST ONE WAS RIGHT BEFORE WE MET IN JUNE IN THE ACD. SO WE CONTINUE TO FOCUS THE EFFORTS ON HIV VACCINES, ON NEW APPROACHES TO TUBERCULOSIS AND A JOINT EFFORT TO SEE IF HPV VACCINES COULD BE SUCCESSFULLY APPLIED IN A SINGLE-DOSE VERSION WHICH WOULD MAKE IT MUCH MORE ACCEPTABLE IN OTHER PARTS OF THE WORLD WHERE THIS STILL HAS NOT BEEN TAKEN ON. SO A COUPLE OTHER THINGS. I KNOW I'M DRONING ON BUT YOU EXPECT THAT, RIGHT. YOU COME FOR THAT. IT'S LIKE PART OF THE PLAN. I MENTIONED BRIEFLY ABOUT PARTNERSHIPS WITH INDUSTRY. I WANTED TO SAY A LITTLE BIT MORE. I MENTIONED PACT, THIS NEW ONE, FORIMMUNOTHERAPY, 12 COMPANIES WORKING WITH NCI. WE TALKED BEFORE AND I THINK GAVE A MORE DETAILED DESCRIPTION OF AMP THE ACCELERATED MEDICAL PROGRAM. TOMORROW MORNING THE EXECUTIVE COMMITTEE WILL BE MEETING WHICH IS ONE OF THE REASONS WE'RE NOT STARTING UNTIL 9:00 TOMORROW BECAUSE I CO-CHAIR THAT GROUP. YOU MAY REMEMBER THIS IS AN EFFORT THAT STARTED THREE AND A HALF YEARS AGO FOCUSSED AFTER MUCH DISCUSSION WITH INDUSTRY ON WHERE THE GREATEST OPPORTUNITIES ARE ON TYPE II DIABETES AND RHEUMATOID ARTHRITIS AND LUPUS. THE WORK PLANS WERE PUT TOGETHER WITH JOINT EFFORTS BETWEEN ACADEMIC SCIENTIST AND NIH AND INDUSTRY SCIENTISTS AND WE'RE VERY FOCUSSED AND TIED TO MILESTONES AND DELIVERABLES. OUT OF THAT HAS COME A REMARKABLE SET OF ACHIEVEMENTS. ON THE ALZHEIMER'S SIDE, A SIGNIFICANT AMOUNT OF FUNDING HAS MADE IT POSSIBLE. IT'S JOINT FUNDING BETWEEN NIH AND INDUSTRY, ROUGHLY 50/50. HAS MADE IT POSSIBLE TO ADD PET SCANS OF TAU AND WE HAVE PRODUCED AN INTERESTING SET OF POTENTIAL DRUG TARGETS THAT WOULD NOT HAVE OTHERWISE BEEN RECOGNIZED WITH A BIG WALL OF TARGETS BEING REFINED AND RELEASED IN THE SUMMER. THE LUPUS TECHNOLOGY EFFORT HAS BEEN INTERESTING. IT'S FOCUSSED ON SYNOVIAL TISSUE FROM PEOPLE WITH ACTIVISH TISSUE AND ACTIVE TISSUE AND PEOPLE WITH LUPUS. IF YOU LOOK AT WHAT'S GOING ON IN THE SYNOVIUM AND IF YOU GET A BIOPSIES, YOU COULD, JUST GRIND IT UP AND SAY WHAT'S HAPPENING IN GENERAL WITH THE IMMUNE CELLS IN THAT TISSUE AS FAR AS THE REMAINING CELL TYPES, BUT BETTER YET LET'S AGGREGATE THIS AND DO THE SINGLE-CELL BIOLOGY. THERE'S A LOT OF IMMUNE SUBTYPES WE DIDN'T KNOW WERE THERE AND YOU CAN SEE THEY'RE THERE BY THEIR RNA SIGNATURE. SOME SEEM TO BE POTENTIALLY MAJOR PLAYERS IN WHAT'S HAPPENING WITH THE INFLAMMATORY RESPONSE BUT WE WOULDN'T HAVE KNOWN THAT WITHOU THE ABILITY TO LOOK CELL BY CELL. IT'S LEADING TO AREAS ABOUT THERAPEUTICS ARE EXCITING. THE TYPE 2 DIABETES HAS BROUGHT TOGETHER THE DATA OF THE GENETIC RISK FACTORS OF WHICH THERE ARE OVER 200 FOR TYPE 2 DIABETES AND IN WHAT WE'RE LEARNING ABOUT PANCREATICISH TU -- TISSUE AND THEIR RNA AND SO ON. THE DATABASE ISLET AND IT'S A PLACE THAT WILL INFORM THEIR DECISION MAKING ON WHAT THEY WANT TO GO AFTER FOR TYPE 2 DIABETES OR COMPLICATIONS OF THAT. I THINK ALL THREE OF THOSE PROJECTS, IN EVERY INSTANCE, MET OR EXCEED THE FORMAT AND IT'S GIVEN CONFIDENCE THIS PARTNERSHIP CAN WORK. WE'RE ON THE BRINK OF ANNOUNCING A FOURTH COMPONENT OF AMP ON PARKINSON'S DISEASE WITH A WELL-WORKED OUT SCIENTIFIC PLAN. JUST TRYING TO GET A FEW OF THE FINAL DETAILS OF THE VARIOUS MEMORANDA WORKED OUT AND AGAIN, A GREAT OPPORTUNITY TO BRING ACADEMICS AND INDUSTRY TOGETHER WITH A SHARED GOAL. AGAIN, MUCH OF THE EFFORT FOR PARKINSON'S WILL BE ON BIOMARKERS. AND THEN THERE'S THE OPIOID ISSUE. WE LOOKED AT WAYS TO END THE OPIOID CRISIS. WE HAD THREE MEETINGS IN JUNE AND JULY AT NIH WITH HEAVY INVOLVEMENT BY INDUSTRY EXPERTS AND FDA AND EXPERTS AND CONSUMER ADVOCATES. ADDITIONAL MEETINGS THAT HAPPENED IN SEPTEMBER INCLUDING MEETING WITH PHARMA, THE TRADE ORGANIZATION THAT'S GOTTEN ENGAGED IN ENCOURAGE THIS KIND OF A PARTSHIP PARTNERSHIP AND I MET WITH A COMMISSION AS THEY WERE ON THE BRINK OF FINAL CONCLUSIONS ON WHAT NEEDS TO BE DONE ABOUT THIS AND ALSO WORKING HARD TO ENCOURAGE INDUSTRY TO TAKE A ROLE IN FINDING SOLUTIONS. SINCE THEN ADDITIONAL MEETINGS THIS WEEK FOR FIGURING OUT HOW TO DETERMINE THE LINKAGES NECESSARY. MONDAY AT NIH WITH OUR PARTNERS BEING A NON-PROFIT WE CAN MEET MANY GOVERNMENT AGENCY AND QUITE A FEW OTHERS, TO MAKE SURE WE'RE WORKING AS CLOSELY TOGETHER IN THE VARIETY OF TOPICS THAT NEED ATTENTION. THEN ON TUESDAY AND WEDNESDAY, THAT WOULD BE THIS WEEK, MANY OF US WERE IN A MEETING UP THE ROAD AT THE BETHESDA CONFERENCE CENTER WITH NO LESS THAN 33 COMPANIES THAT SENT HIGH-LEVEL REPRESENTATIVES OF WHAT WOULD BE A WORK PLAN FOCUSSED IN SEVERAL WAYS. THE FOCUS WOULD BE ON THE CURRENT CRISIS OF OPIOID USE DISORDERS AND ADDICTION BY DEVELOPING MORE OPTIONS AND MORE EFFECTIVE OPTIONS FOR TREATING ADDICTION. WE KNOW MEDICATED ASSISTED TREATMENT IS NECESSARY IF YOU'LL AVOID RELAPSE OTHERWISE RELAPSE IS HIGH. THERE'S A NUMBER OF OPTIONSES FOR NAT ARE MORE LIMIT AND FOCUS IS ON OVERDOSE TREATMENT. WHILE WE HAVE IT IN THE FORM OF NASAL NARCAN WHICH, THERE'S CONCERNS NOW WITH FENTANYL AND CARFENTANYL IN THE HEROIN SUPPLY THE ANTIDOTE MAY NOT BE AS LONG AS IT NEEDS TO BE TO AVOID RESPIRATORY RISK. AND MORE WORK NEEDS TO BE DONE THERE AND THERE'S INTENSE INCENTIVE TO DEVELOP PAIN MEDICATION THAT IS NOT ADDICTIVE FOR WHOM OPIOIDS IS NOT A GOOD ANSWER. WE'LL TALK ABOUT THIS TOMORROW AND WE'LL GO INTO A LOT OF THE SCIENCE IN GREATER DEPTH THAN TIS RIGHT NOW. I THINK IT'S FAIR TO SAY THE MEETINGS IN THE LAST COUPLE DAYS BROUGHT TOGETHER FOR THE FOUNDATION FOR NIH FOR THIS CATALYST HAS GONE A LONG WAY INTO A MORE SPECIFIC AND DETAILED PLAN ON WHAT SHOULD BE AND COULD BE DONE AT THIS TIME OF GREAT URGENCY. UNCERTAINTY ABOUT ALL THIS IS WHERE THE MONEY'S GOING TO COME FROM. THERE'S BEEN NO ADDITIONAL ALLOCATION OF FUNDS. WHILE THERE'S BEEN $1 BILLION PUT INTO TREATMENT PROGRAMS THERE'S BEEN NO ADDITIONAL SUPPORT FOR RESEARCH. AT RECENT HEARINGS I'VE BEEN ASKED THAT QUESTION I'VE INDICATED THE NEED IS GREAT IF WE'RE FOCUSSED ON PUTTING THE FOOT DOWN ON THE ACCELERATOR AND MENTIONED $500 PMILLION A YEAR FOR A FIVE-YEAR PERIOD WITH HOPE INDUSTRY WOULD COVER SOME OF THE COST AS WELL. WE SHALL SEE AND AS YOU'LL HEAR ABOUT FROM ADRIAN IT'S UP IN THE AIR IN TERMS OF WHAT YOU WANT TO EXPECT IN TERMS OF THE BUDGET DEL DELIBERATION AND SPECIAL NEEDS SUCH AS OPIOIDS. ANYWAY, THIS HAS OCCUPIED A LOT OF TIME OF MYSELF, LARRY, CARRIE, OF NORAH AND WALTER KORSHETS AND WE HOPE TO DO OUR PART TO COME UP WITH WHENEVER WE CAN TO ADDRESS THIS VERY CHALLENGING ISSUE, WHICH IN THE COURSE OF THE FEW YEARS IS GETTING WORSE AND WORSE. IT'S NOW IN THE NUMBER OF 175 PEOPLE A DAY ARE DYING OF OVERDOSES. MOST OPIOIDS. MORE PEOPLE DYING DAILY NOW THAN AT THE PEAK OF THE AIDES EPIDEMIC AND CASH CRASHES. IT'S ALL HAPPENED ON DECK. WHILE NIH CAN'T BE IN A POSITION TO ADDRESS MANY OF THE SOCIAL ISSUES THAT GOT US INTO THIS DIFFICULT SPOT THERE ARE THINGS WE'RE DETERMINED TO DO AND DO THEM. OKAY. I'M GETTING THERE. HOW ARE Y'ALL HOLDING UP? I DIDN'T WANT TO SAY A LITTLE BIT ABOUT THE 21st CENTURY CURES ACT AND THE INNOVATION CURES ACT AND I'LL MENTION IT, THERE WERE FOUR INITIATIVES SUPPORTED BY CURES ACT. ONE BEING THE PRECISION MEDICINE INITIATIVE INCLUDING THE ALL OF US PROJECT. ANOTHER BEING THE BRAIN INITIATIVE. ANOTHER BEING THE CANCER MOON SHOT AND ANOTHER BEING REGENERATIVE MEDICINE. WE'LL HEAR MORE ABOUT REGENERATIVE MEDICINE AND IN ADDITION TO THAT THEY'VE GIVEN MORE THAN 100 AWARDS WITH THE MONEY IN FY17 AND MORE TO COME. AND BRAIN WAS A CREATION OF THIS ACD. WE DID NOT HAVE THAT PROJECT AND IT'S AMAZING MILESTONES HAD IT NOT BEEN FOR THE WORKING GROUP THAT WAS ASSEMBLED THROUGH YOU ALL AND HAS THE PLAN FOR 2025 ONE WE'RE ACTIVELY PURSUING. THE BRAIN NOW IN PHYSICAL YEAR '17 WITH THE SUPPORT FROM THE BASE APPROPRIATIONS AND A BIT FROM THE CURES ACT WERE ABLE TO ISSUE SUBSTANTIAL NUMBER OF NEW AWARDS, 130 OF THEM JUST IN OCTOBER. A BIG FOCUS NOW ON GETTING A CENSUS OF THE CELLS IN THE BRAIN USING SINGLE-CELL BIOLOGY AND THERE'S EXCITEMENT ON WHAT THAT MAY BE ABLE TO TELL US AND CONTINUED INVESTMENTS IN TECHNOLOGY DEVELOPMENT. WE STILL FEEL WHERE A LOT OF NEED IS TO ASSESS WHAT'S HAPPENING IN REAL TIME WITH COMPLICATED CIRCUITS. THE PRECISION MEDICINE PART OF THE CURES ACT AGAIN WITH ITS CENTERPIECE BEING ALL OF US, THAT'S ANOTHER CREATION AND RICK ON THE PHONE AND HAS A LOT TO DO WITH THE INITIATIVE. I THINK WE'RE MAKING TERRIFIC PROGRESS IN WHAT IS GOING TO BE THE MOST BOLD, LARGE-SCALE COHORT EFFORT IN THE UNITED STATES ABLE TO ENROLL 1 MILLION PARTICIPANTS AND ASK HEM -- THEM AVAILABLE THEIR MEDICAL RECORDS AND THE DIRECTOR OF THE EFFORT AND WITH HIS CONSIDERABLE EXPERIENCE HAS BROUGHT LOTS OF VISION TO THIS AND WE'RE NOW IN THE PHASE OF A BETA TEST OF EFFORTS UNDERWAY WHICH INVOLVE MORE THAN 100 ORGANIZATIONS IN VARIOUS WAYS IN HOW WE'RE DOING ENROLLMENT. WE CAN ENROLL THROUGH A HEALTH PROVIDER ORGANIZATION AND ENROLL THROUGH THE COMMUNITY HEALTH CENTERS OR ENROLL BY BEING A DIRECT VOLUNTEER. ALL THOSE HAVE TO BE TESTED OUT IN THIS BETA TEST PHASE. WELL OVER 10,000 INDIVIDUALS WHO HAVE SIGNED UP AS PART OF THE BETA TEST AND 8,000 OF THEM ARE NOW FULLY ENROLLED. THEY'VE DONE ALL THE STEPS. THE OTHERS ARE IN THE PROCESS. DOING SO. WE'VE LEARNED A LOT ALONG THE WAY. THE BIOSPECIMEN EFFORT AT MAYO WITH CAPACITY WITH 32 MILLION SAMPLES AND FULLY AUTOMATED AND ROBOTIZED IS WORKING WELL. WE PAID A LOT OF ATTENTION TO RECORDS. WHAT I WORRY ABOUT IS A BREACH OF SECURITY WHEN WE'RE ASKING PEOPLE TO MAKE THEIR ELECTRONIC HEALTH RECORDS AVAILABLE AND WE'VE HAD HACKATHONS AND PENETRATION TESTS AND THE THINGS YOU SHOULD DO. I THINK WE'RE IN VERY GOOD SHAPE TO SAY WE HAVE ABOUT THE MOST CAREFUL THOUGHT THAT'S GONE INTO THIS AND THE END TO END ENCRYPTION YOU'D WANT TO SEE. SO I'M PRETTY OPTIMISTIC WE'RE ON TRACK FOR A FULL LAUNCH OF THIS, AT WHICH POINT THERE'S A LOT OF PUBLIC NOISE IN THE SPRING AND I WON'T SAY A SPECIFIC DATE AND SINCE WE'RE STILL TESTING THESE THINGS. SPRING OF 2018. IF YOU WANT TO KNOW MORE ABOUT THIS AND GET ON THE E-MAIL LIST TO GET REGULAR UPDATES, IF YOU GO TO JOIN ALL OF US, JUST ONE WORD, DOT ORG YOU'LL GET THOSE KINDS OF FEEDBACKS IN YOUR E-MAIL AND I HOPE ALL THE MEMBERS OF THE ACD WILL WANT TO JOIN UP WHEN WE GET TO THAT POINT. SO, WHILE I'M MENTIONING ALL OF US, I DO WANT TO MENTION JEFF GINSBURG'S EFFORT BECAUSE WE HAVE A SIGNIFICANT OPPORTUNITY HERE WITH ALL OF US PLANNING TO ENROLL 1 MILLION PARTICIPANTS, WE'RE NOT THE ONLY PLACE ON THE PLANET THINKING ABOUT THIS AS AN EXCITING OPPORTUNITY TO LEARN ABOUT HEALTH AND DISEASE. JEFF, AS PART OF HIS ROLE AND WORKING WITH TERRY MINOLIO HAS AGREED TO HOST IN MARCH IN DURHAM AT DUKE AN INTERNATIONAL COHORTS SUMMIT TO BRING TOGETHER THE PIs OF MANY OF THE LARGE-SCALE EFFORTS TO TRY TO SEE WHETHER WE CAN MAKE THIS EVEN BETTER BY HAVING SOME AGREEMENTS BY STANDARDS, ABOUT HOW THE DATA'S GOING TO BE REPRESENTED AND DATA CAN BE SHARED. >> THANKS, IT'S COMING TOGETHER. AND A COMMITMENT TO ENROLL 1 MILLION AND WE HAVE GOTTEN CONFIRMATION BY 60 OF THOSE AND WE'LL COLLABORATE AND HOPEFULLY AT THE LEAST WE'LL HAVE A CATALOG OF WHAT THE COHORTS ARE AND HOW PEOPLE CAN ACCESS THEM. PERHAPS. AND I DO WANT TO INTRODUCE NOW FIRST NEIL SHAPIRO AND ADRIAN HALETZ TO TALK ABOUT THE LEGISLATIVE ISSUES WE THOUGHT YOU'D BE INTERESTED IN HEARING FIRST THE ASSOCIATE DIRECTOR FOR BUDGET. >> WE'RE UNDER A CONTINUING RESOLUTION. IT STARTED OCTOBER 1. THE WAY I WOULD DESCRIBE IT IS THE GOOD NEWS IS THAT WE AVOIDED A GOVERNMENT SHUTDOWN TWICE. BUT THAT MEANS WE NEED IT DO IT AGAIN NEXT WEEK. SO FINGERS CROSSED. THE GOVERNMENT STAYS OPEN AND IT'S EXPECTED PROBABLY THAT WE'LL SEE A CR INTO JANUARY BY COMPARISON TO LAST YEAR WHEN WE HAD THREE CRs. THE SECOND ONE, AT THAT TIME, WENT TO LATE APRIL BUT WE DON'T HAVE A CHANGE OF ADMINISTRATION THIS TIME AROUND AND SO THINGS ARE LOOKING MUCH BETTER IN TERMS OF GETTING FINAL APPROPRIATIONS THIS WINTER AND BEING ABLE TO MOVE FORWARD. THE FUNDING LEVEL FOR THE CR IS ABOUT $34 BILLION. THERE'S A SMALL AND THE ISSUES IN TERMS OF MAKING PROGRESS ON GETTING FINAL APPROPRIATION, ADRIAN WILL BE TALKING TO YOU ABOUT MORE. YOU'VE SEEN IN THE NEWS PARTICULARLY AT ME MOMENT WITH THE TAX BILL AND SO THOSE ACTIVITIES IN CONGRESS HAVE SLOWED THINGS DOWN A LITTLE BIT IN TERMS OF MAKING PROGRESS IN TERMS OF GETTING AN OMNIBUS BILL FOR 2018. AND THEY NEED TO KNOW WHAT'S IN THE WHOLE BILL AND THE WHOLE BILL WILL DEPEND ON DISCRETIONARY CAPS. THE CURRENT CAPS WERE SET FOR TWO YEARS AND WITH THE EXPIRATION OF THAT LAST ADJUSTMENT, THAT'S ME NEXT BIG THING TO HAVE A BUDGET DEAL THAT WOULD ALLOW THE PROCESS TO CONTINUE ON. THAT HOPE IS THAT WILL HAPPEN QUICKLY AND WE'LL SEE OUR FINAL 2018 APPROPRIATIONS IN HOPEFULLY THE JANUARY TIME FRAME. THE LAST BULLET HERE IN TERMS OF OUR TYPE 1 DIABETES FUNDING. THAT'S A SEPARATE PIECE. IT'S NOT IN THE APPROPRIATIONS BILL AND HAS TO BE PASSED BY CONGRESS SEPARATELY. THE LAST TIME IT WAS RE-AUTHORIZED WAS FOR '16 AND '17. CURRENTLY THAT ALSO NEEDS TO BE PASSED BY CONGRESS. IT'S IN A BILL THAT'S GOTTEN THROUGH THE HOUSE. IT HAS NOT PASSED THE SENATE AT THE MOMENT AND WE'RE HOPEFUL THAT WILL GET RE-AUTHORIZED AND WILL CONTINUE AS IT HAS FOR MANY YEARS. SO WE HAD IN TERMS OF WHAT CONGRESS HAS DONE IN 2018 SO FAR, BOTH THE HOUSE AND SENATE WERE ABLE TO TAKE THEIR APPROPRIATIONS BILLS THROUGH FULL COMMITTEE AND ISSUE A BILL AND A REPORT FOR 2018. THAT DOESN'T HAPPEN EVERY YEAR SO IT'S POSITIVE WE HEARD FROM THE HOUSE AND SENATE ON THEIR PRIORITIES FOR THE FISCAL YEAR. IN THE HOUSE THE LEVEL IS $1.1 BILLION AND ABOUT $35 BILLION AND IT SET A PATH FORWARD FOR THE INNOVATION PROJECT. THE HOUSE BILL DOES INCLUDE THE FULL 2018 INCREMNT AN INCREASE TO $496 MILLION FOR 2018. THAT TOO IS POSITIVE. THEN IN TERMS OF THE SPECIFICS IN THE BILL, THERE ARE TARGETED INCREASING FOR THINGS LIKE ALZHEIMER'S DISEASE, ALSO BECAUSE EITHER BECAUSE OF THE CURES BILL OR IN ADDITION TO THE CURES BILL THE BRAIN INITIATIVE OR ALL OF US PROGRAM AND THE REMAINDER OF THE FUNDING IS DISTRIBUTED ACROSS THE REST OF NIH. THIS WERE A COUPLE PROPOSALS IN THE BUDGET FOR 2018 THE HOUSE DID NOT ACCEPT. THERE WERE CONSOLIDATIONS AND THOSE WERE TO MERGE THE AGENCY FOR HEALTH CARE RESEARCH AND EQUALITY. ANOTHER HHS AGENCY WAS GOING TO BE CONSOLIDATED WITH NIH AND THE FOGARTY INTERNATIONAL CENTER WOULD BE MERGED TO THE OFFICE OF THE DIRECTOR. NEITHER OF THOSE PROPOSALS WERE ACCEPTED IN THE HOUSE BILL. THERE WITH US ALSO A POLICY TO CHANGE THE INDIRECT COST FOR RESEARCH GRANTS. IT WOULD HAVE BEEN LIMITED TO 10% OF TOTAL COSTS OPPOSED TO THE WAY IT'S DONE NOW THAT ALSO WAS NOT ACCEPTED IN THE HOUSE BILL. THEN WITH THE SENATE BILL, THE FUNDING LEVEL IS HIGHER. AGAIN -- >> PARDON THE INTERRUPTION, YOUR CONFERENCE CONTAINS RLESS THAN THREE PARTICIPANTS IF YOU'D LIKE TO CONTINUE PRESS STAR 1. >> THERE WITH WE GO. THE INCREASE IS $2 BILLION TO $36 BILLION TOTAL. THE INCREASES ARE SIMILAR. ALZHEIMER'S IS THE LARGEST AS WELL AS THE OTHERS THAT WERE MENTIONED BEFORE. THE DIFFERENCE WITH THE ADDITIONAL FUNDS THE $900 MILLION FUNDS MEANS A GENERAL INCREASE ACROSS THE BOARD FOR NIH INSTITUTE IN THE HOUSE. THEN AGAIN WITH THE SENATE, THEY TOOK THE SAME POSITION IN TERMS OF CONSOLIDATIONS AND INDIRECT COST POLICY THE HOUSE HAD. ONE ADDITIONAL THING TO MENTION IN TERMS OF THE INDIRECT POLICY IS THAT THE HOUSE AND SENATE BOTH FELT STRONGLY ENOUGH ABOUT THAT PARTICULAR PROPOSAL THEY INCLUDED A PROVISION IN THE CURRENT CONTINUING RESOLUTION ABOUT IT AND THAT PROVISION BASICALLY REQUIRES NIH TO CONTINUE COMPLYING WITH EXISTING REGULATIONS ON INDIRECT COSTS AND ALSO PROHIBITS THE USE OF APPROPRIATED FUNDS TO DEVELOP OR IMPLEMENT A MODIFIED APPROACH TO INDIRECT COSTS. THEY WERE PARTICULARLY EMPHATIC IN TERMS OF THAT PROPOSAL FROM THE PRESIDENT'S BUDGET. BUT THAT IS THE GIST OF WHERE WE ARE TODAY UNTIL WE HEAR MORE FROM CONGRESS. >> GREAT, THANK YOU. WE CAN SAVE QUESTIONS UNTIL AFTER ADRIAN PRESENTS BECAUSE IT MAY BE APPROPRIATE TO HAVE BOTH OF YOU THEN SEE WHAT PEOPLE WANT TO TALK ABOUT. HAVING THESE MEETINGS IN SEPTEMBER TENDS TO THRUST US INTO UNCERTAINTY. >> I'M WATCHING MY PHONE FOR A REASON. >> AS FRANCIS MENTIONED WE HAD A NUMBER OF FALL HEARINGS. MOST ARE IN THE SPRINGTIME SO HAVING A NOVEMBER SPRINT WAS QUITE INTERESTING. FRANCIS WASN'T INVOLVED IN FOUR OF THE EVENTS. THE FIFTH AT THE BOTTOM, WE HAD INTEREST FROM THE AFRICA SUBCOMMITTEE OF THE HOUSE COMMITTEE ON ALZHEIMER'S. THAT'S AN INTERESTING MOVE FOR US TO TALK ABOUT THIS IN A MORE GLOBAL CONTEXT. IT'S AN EXCITING INNOVATION TO TALK TO THEM ABOUT NIH IN ADDITION TO THE STATE DEPARTMENT WHO THEY OFTEN GO TO FOR THESE TYPES OF EVENTS. THAT WAS EXCITING FOR US. I WANTED TO TALK TO YOU A LITTLE BIT ABOUT WHAT IS GOING ON RIGHT NOW. WHAT IS HOLDING US UP? WHY DON'T WE HAVE A BUDGET DEAL? WHY DO WE NEED ONE? THIS IS THE DISCRETIONARY SPENDING CAPS SINCE 2010 WHEN THE TEA PARTY CAME INTO CONGRESS AND WE STARTED HAVING INTENSE CONVERSATIONS ON THE BUDGET. THIS IS TOTAL DISCRETIONARY SPENDING INCLUDING THE DEFENSE DEPARTMENT. OFTEN YOU'LL SEE IT SPLIT INTO DEFENSE AND NON DEFENSE. THIS IS ALL TOGETHER. YOU'LL SEE DRAMATIC CUTS IN THE FIRST TWO YEARS AND THEN WE HAD THIS DECISION POINT OVER THE SEQUESTER. IN THE BUDGET CONTROL ACT THERE WERE ACTUALLY TWO SEQUESTERS. ONE ON THE FRONT OF END AND BACK END. THE FRONT END ONE TOOK PLACE. AS YOU REMEMBER OUR SUPER COMMITTEE DID NOT ACHIEVE THE KIND OF SAVINGS IT ANTICIPATED. WE WENT FROM THIS DOTTED LINE WHICH WAS EXPECTED DOWN TO THE OTHER DOTTED LINE, THE LONGER DOTTED LINE. MEMBERS DIDN'T LIKE THESE DRAMATIC CUTS. SO WERE TWO-YEAR DEALS THAT SOFTENED THE BLOW. THAT HAS NOW RUN OUT AS OF 2017. SO WHERE DO WE GO FROM HERE. 2018 WE RETURN TO THE SEQUESTER LINE. YOU CAN SEE WHAT'S GOING ON. THE FIRST DARK BLUE COLUMN IS WHAT DID WE APPROPRIATE IN FY17. IT ALSO SHOWS THE LIGHTER BLUE IS THE '17 CAPS. THE REASON THIS IS IMPORTANT THERE ARE REASONS WHY WE GO ABOVE THE CAPS AND EMERGENCY SPENDING IS THERE AND WHEN CAPS ARE WHAT IS DEBATED IN CONGRESS, THE TALLER BLUE LINE SHOWS WHAT THEY'RE SPENDING AND WHEN THEY TALK ABOUT THE CUTS THEY TALK ABOUT IT FROM THE LOWER BLUE LINE. SO WHEN YOU READ YOUR NEWSPAPERS THEY MIGHT COME AT IT FROM DIFFERENT NUMBERS. THAT'S THE DIFFERENCE. CURRENT LAW, YOU SEE THE SEQUESTER CUTS, THEY LOOK SOMEWHAT SMALL SO THERE'S A $3 BILLION CUT. IT WILL FEEL LIKE A CUT FROM 554 TO 516. ON THE DEFENSE SIDE THERE'S VARIOUS REASONS WHY WE SPENT ABOVE THE CONTINGENCY OPERATIONS AND SOME PEOPLE CALL IT A GIMMICK AND SOME CALL IT MILITARY SERVICES. THE CAP IS 551 BUT FIELDS LIKE 634 IF YOU'RE IN THE MILITARY OR IMPACTED BY MILITARY SPENDING THE SEQUESTER CAP IS 549. THERE'S TWO SEQUESTERS IN LAW. THERE'S THE FRONT-END SEQUESTER WE'RE LIVING UNDER AND A BACK-END SEQUESTER WHICH MEANS THE ORANGE LINES ARE THE CAPS. IF CONGRESS PASSES BILLS THAT GO OVER THOSE LINES WITHOUT CHANGING THE CAPS, THERE'S AN AUTOMATIC SEQUESTER THAT COMES INTO PLACE AND AN ACROSS THE BOARD CUT AND THAT GOES BACK TO THE TREASURY. SO IF YOU'RE IN THE CONGRESS AND GOING TO PASS A DEFENSE BILL ABOVE BUT YOU DON'T CHANGE THE CAPS IT'S NOT WORTH YOUR TIME. IT'S GOING TO GO ACROSS THE BOARD RIGHT DOWN TO THE CAP. THAT'S WHY YOU HEAR THE DEFENSE HAWKS SAYING WE NEED A BUDGET DEAL EVEN WHILE THEY'RE PASSING BILLS WAY ACROSS THE CAPS. BOTH SIDES NEED A BUDGET DEAL TO ACHIEVE THEIR GOALS. THE PRESIDENT'S BUDGET DOES AN INTERESTING THING. THE PRESIDENT'S BUDGET SAYS I WANT TO LIVE UNDER THE CAP AS A WHOLE BUT I DON'T WANT TO LIVE UNDER THE DISTRIBUTION. SO THE PRESIDENT'S BUDGET TAKES $54 BILLION BELOW THE SEQUESTRATION CAP ON NON-DEFENSE AND PUTS IT ON THE DEFENSE SIDE. HIS ARGUMENT IS I DON'T NEED TO CHANGE THE TOTAL GAP. I'M FINE UNDER TOTAL AM OF SPENDING, I JUST WANT TO SHIFT IT. THESE CAPS ARE IN LAW AND IN LAW PRESENTLY SO THE PRESIDENT ALSO NEEDS A BUDGET DEAL. THAT'S WHY IF YOU'RE IN THE NON-DEFENSE WORLD OR DEFENSE WORLD, OR ADMINISTRATION, EVERYBODY WANTS A BUDGET DEAL. IT DOESN'T MEAN IT'S EASY TO GET. THESE ARE THE THINGS PEOPLE ARE SAYING WELL, IF THERE'S A BUDGET DEAL WE'RE RAISING CAPS. WE NEED SOME FUNDING FOR THE OPIOID CRISIS. $1 BILLION FOR A TREATMENT ACROSS 50 STATES OVER TWO YEARS IS NOT A GREAT DEAL OF FUNDING ON THE GROUND. WE HAVE HAD A RECORD HURRICANE SEASON. WE ARE HAVING -- WE ARE IN THE MIDST OF A RECORD FIRE SEASON. THERE'S ALSO AN INTERESTING STORY, I'VE ONLY SEEN ONE LITTLE STORY ON THIS BUT I THINK IT WILL START TO BUBBLE UP. WE ALMOST HAD A SHUT DOWN LAST YEAR BECAUSE THE COAL MINER'S HEALTH CARE PLAN WAS RUNNING OUT AND JOE MANCHIN SAID I'M NOT VOTING FOR ANYTHING UNTIL YOU FIX THE ISSUE. THEY FIXED THE HEALTH CARE PLAN BUT NOT THE PENSION PLAN. SO THE PENSION PLAN FOR COLE -- COAL MINERS AND TRUCK DRIVERS AND FOOD SERVICE WORKERS ARE RUNNING OUT OF MONEY. THAT'S 400,000 PEOPLE IN THE UNITED STATES IMPACTED BY THIS. THIS SAY LITTLE STORY NOW BUT I EXPECT TO GET BIGGER. THESE ARE COMING INTO PLAY AS YOU SEE THE BUDGET TALKS ACCELERATE. NOW, IT WOULDN'T BE CONGRESS IF THEY DIDN'T THROW OFF MY PRESENTATION THE MORNING OF. THESE ARE THREE STORIES THAT HAVE COME OUT IN THE LAST 12 HOURS THAT I THINK ARE REALLY IMPACTFUL AND I'M REALLY FOLLOWING. SO REPUBLICAN TAX BILL. THEY HAVE REACHED SOME SORT OF AGREEMENT. THEY HAVE NOT RELEASED THAT AGREEMENT. IN FACT THE CONFERENCE COMMITTEE OF BOTH HOUSE AND SENATE MEMBERS THAT HAVE TO APPROVE THAT TO GO BACK FOR A VOTE IS MEETING THIS AFTERNOON. WE HAVEN'T SEEN THE DALE -- DEALER A SUMMARY AND THE JOINT TAX COMMITTEE HAS NOT SCORED THE DEAL SO WE DON'T KNOW HOW MUCH IT'S GOING TO COST. THERE ARE RUMORS LEAKING OUT, SOME ARE EVEN WILLING TO GO ON RECORD, REPUBLICAN SENATOR OF MONTANA SAID THE GRADUATE SCHOOL TUITION WAIVER IS TAXABLE INCOME AND WE'RE WATCHING TO MAKE SURE MR. DANES WAS ACCURATE IN HIS REPORTING AND WE'LL BE KEEPING EVERYBODY UP TO DATE ON THAT. THE SECOND ANNOUNCEMENT THIS MORNING IS LATE LAST NIGHT THE HOUSE MAJORITY INTRODUCED A BILL TO EXTEND THE GOVERNMENT SPENDING DEADLINE FROM DECEMBER 22 TO JANUARY 19. HERE'S THE TRICK, IT ALSO INCLUDES A FULL-YEAR BILL FOR THE DEFENSE BILL. pNOR -- FOR NON-DEFENSE AND LET'S GO BACK FOR A SECOND. NOW WE'RE AT 634 INCLUDING OCO. THE CAPS ARE 549. EVEN THE DEFENSE AUTHORIZATION BILL WHICH HIGHER THAN ANY OTHER PROPOSAL IS 626. THIS SAY $640 BILLION DEFENSE BILL. I THINK IT WILL BE HARD TO PASS. I DON'T KNOW. THEY'RE MEETING THIS MORNING. THE HOUSE REPUBLICAN LEADERS ARE MEETING THIS MORNING TO FIND OUT IF THEY'LL HAVE THE VOTES TO PASS IT. IT'S NOT CLEAR TO ME THEY HAVE THE VOTES IN THE HOUSE. IT'S SOMEWHAT CLEAR TO ME THEY DON'T HAVE THE VOTES IN THE SENATE. UNLIKE THE TAX BILL WHERE THEY NEED A SIMPLE MAJORITY OF 51 MEMBERS, IN THE FILIBUSTER WORLD THEY NEED 60 MEMBERS EVEN IF THEY GOT 100% OF THE REPUBLICANS THEY WON'T BE ABLE TO PASS THIS. THE RUMORS I HAVE HEARD, AND THEY'RE JUST RUMORS BECAUSE IT HAPPENED LATE LAST NIGHT AND I WAS WITH PEOPLE ON THE PHONE AND THERE'S AN EMERGING IDEA IF THE BILL MAKES IT TO THE SENATE THEY'LL STRIP OUT THE DEFENSE BILL AND INCLUDE DISASTER SPENDING. THERE'S NO DISASTER SPENDING IN THIS PACKAGE. YOU SEE THIS OTHER STORY EARLIER LAST NIGHT WHERE PEOPLE VERY HIGH IN THE SENATE ARE SAYING WE DON'T LIKE THE IDEA THEY'RE PUTTING FORWARD A BILL THAT PUNTS OUR STATE NEEDS -- REMEMBER, THIS IS TEXAS AND CALIFORNIA AND BIG DELEGATIONS IN THE HOUSE OF REPRESENTATIVES, WE DON'T LIKE YOU'RE PUNTING OUR DISASTER NEEDS UNTIL JANUARY. THAT'S WHY I SORT OF WONDER IF THE BILL WILL EVEN PASS THE HOUSE BECAUSE THERE ARE A LOT OF REPUBLICAN MEMBERS FROM TEXAS REALLY FOCUSSED ON GETTING DISASTER AID. THEY'RE SAYING THEY'RE GOING TO PASS IT WEDNESDAY AND GETTING OUT OF TOWN. LANES GO BOTH WAYS. I DON'T KNOW. THIS SAY CALENDAR. SO I'VE CIRCLED THE 14th. WE DON'T HAVE A LOT OF TIME LEFT UNTIL THE END OF THE YEAR. THERE ARE A COUPLE OF THINGS THAT PEOPLE ARE FOCUSSED ON GETTING DONE. IN ADDITION TO ALL THE WANTS, THESE ARE SORT OF THE NEEDS. SO THE CHILDREN'S HEALTH INSURANCE HAS EXPIRED. STATES ARE RUNNING OUT OF MONEY. THEY'VE BEEN PUTTING THEIR OWN MEDICAID DOLLARS IN TRUSTING THE GOVERNMENT WILL PAY THEM BACK. IT'S STARTING TO FALL THROUGH. STATES ARE LOSING CONFIDENCE. IN THE MOST RECENT CR THERE WAS A PROVISION THAT DIDN'T EXTEND THE PROGRAM BUT ALLOWED THE GOVERNMENT TO GIVE THOSE STATES SOME MONEY TO SHORE THEM UP FOR A LITTLE WHILE THROUGH THE END OF THE YEAR. PEOPLE WANT TO PERMANENTLY EXTEND THE PROGRAM. THERE SAY LONGER EXTENSION IN THE HOUSE BILL THAT THEY INTRODUCED LAST NIGHT. RUMORED, AGAIN, I HAVEN'T SEEN TEXT ON THIS ALL I'VE SEEN ARE NEWS SUMMARIES. ON DECEMBER 12 THE OTHER THING THAT WAS INTERESTING THIS WEEK IS TREASURY SENT A LETTER TO CONGRESS AND SAID YOU WERE SERIOUS ABOUT THE DEBT CEILING, WE'RE HITTING IT AGAIN AND THEY DID THEIR FIRST EXTRAORDINARY MEASURE. THAT WAS HALTING INVEST MANY IN THE GOVERNMENT PENSION G-FUND. THAT'S SORT OF THEIR CASH-SHIFTING MODEL. THAT'S WHAT THEY'RE DOING. THERE IS ALSO A CONVERSATION TO BE HAD. THERE WAS A PLAN -- AND I THINK IT'S GOING TO BE IN THE TAX PACKAGE WHEN WE SEE IT, THAT MANY OF THE PROVISIONS TAKE EFFECT ON JANUARY 1. THAT'S REALLY [INDISCERNIBLE] IT'S GOING TO REQUIRE A LOT OF CHANGES. AND NOT CLEAR TO ME HOW THAT AFFECTS THE DEBT CEILING TIMING IN TERMS OF MONEY COMING INTO TE GOVERNMENT. EARLIER THIS YEAR, PRESIDENT TRUMP ANNOUNCED THE COST-SHARING REDUCTION PAYMENTS. SENATOR COLLINS, IN VOTING FOR THE TAX PACKAGE TO GET THROUGH THE SENATE, GOT A COMMITMENT THE SENATE WILL MOVE TO COST-SHARING OPTION. WE'LL SEE WHERE THAT SHAKES OUT AND WHERE THAT SITS IN THE END OF YEAR VEHICLES MOVING AND TAX REFORM WHICH, OUR UNDERSTANDING IS THE HOUSE WILL VOTE ON IT WEDNESDAY. THIS IS NEXT YEAR BECAUSE I'M A GLUTTON FOR PUNISHMENT AND THOUGHT LET'S LOOK AHEAD. THIS IS THE CONGRESSIONAL CREDIT CARD. I'VE WHITED OUT THE DAYS NEITHER BODY SIN SESSION. SOFT OF THE DAYS IN BLACK ONLY ONE BODY IS IN SESSION AND PUT IN COLOR-CODED KEY DATES. THE PRESIDENT'S BUDGET REQUEST. IT'S NOT CLEAR TO ME WHEN WE'LL SEE AN OMNIBUS. IT IS ENTIRELY DEPENDENT ON THE BUDGET DEAL. NEGOTIATORS IN THE CONGRESS CANNOT EVEN START UNTIL THEY KNOW HOW MANY BILLIONS OF DOLLARS THEY'RE DEALING WITH. THE DIFFERENCE OF $50 BILLION MATTERS A LOT WHEN YOU GET DOWN TO THE DETAILS. DACA EXPIRES MARCH 6. SOME TIME IN MARCH WE BELIEVE IT WILL RUN OUT AND CHILDCARE ENTIT ENTITLEMEN ENTITLEMENTS EXPIRE NEXT YEAR. I PUT THIS UP TO REMIND YOU WE'LL BE AN ELECTION SEASON. WE HAD FIVE MEMBERS OF CONGRESS WHO MOVED INTO THE ADMINISTRATION SO WE'VE HAD A LOT OF SPECIAL ELECTIONS THIS YEAR AND A LOT OF GUBERNATORIAL ELECTIONS THIS YEAR BUT THIS IS REALLY GOING TO BE INTENSE FOR CONGRESS BEEN -- I EXPECT IT WILL IMPACT THEIR ABILITY TO GET THINGS DONE NOT THAT THEY GOT A LOT DONE OR MAYBE THE VOTERS WILL INSPIRE THEM TO HAVE A BURST OF PRODUCTIVITY. IT'S YET TO BE SEEN. IN TERMS OF THIS WHERE WE'VE BEEN LIVING THE LAST TEN YEARS IS A CONGRESS VERY NARROWLY DIVIDED. NEITHER PARTY HAS EVEN THE HOPE OF A GOVERNING MAJORITY. SO THEY'RE REALLY OPERATING ON THE MARGINS. IN TERMS OF THE HOUSE, YOU'LL READ A LOT OF POLSTERS THAT SAY IT'S POSSIBLE FOR THE DEMOCRAT TO TAKE THE HOUSE, NOT POSSIBLE FOR THE DEMOCRAT TO TAKE THE HOUSE. I'M NOT HERE TO SWAY YOU EITHER WAY BUT IT GOES DISTRICT BY DISTRICT. WE DON'T VOTE ON THE HOUSE ON NATIONAL PUBLIC OPINION. THERE ARE 21 CARRIED BY SECRETARY CLINTON, JUST 12 DEMOCRATS BY PRESIDENT TRUMP. THAT MEANS THERE'S NOT A LOT OF SPLITTING THE TICKET. ALABA ALABAMA WOULD BELIE THAT. WE'LL SEE UNLESS THEY WIN AT LEAST ONE OF THE DISTRICTS TRUMP CARRIED IN 2016 THE DEMOCRATS HAVE NO MATHEMATICAL ROUTE. THERE COULD BE A WAVE ELECTION. pNEXT NOVEMBER IS A LONG TIME FROM NOW. ALSO IN THE SENATE, THOUGH IT IS TRUE THAT THE PRESIDENT'S PARTY TYPICALLY LOSES SEATS IN A MID-TERM ELECTION THE DEMOCRATS ARE PROTECTING MOW GROUND THIS YEAR. YOU'LL SEE IT'S POSSIBLE THE DEMOCRATS CAN TAKE THE SENATE. IT'S A MUCH MORE UP HILL CLIMB IS WHAT I WOULD TELL YOU AND I DON'T EXPECT THIS BIPARTISAN DYNAMIC TO CHANGE MUCH IN THE COMING YEAR BECAUSE THE PARTIES ARE FLIPPING WHO'S DEFENDING MORE SPACE. WHAT THAT MEANS FOR OUR PURPOSES IS THAT WHEN PARTIES ARE CLOSE TO TAKE OVER, WHAT THEY WANT TO DO FOR THE VOTERS IS DISTINGUISH THEMSELVES. THEY WANT TO HAVE A NARRATIVE WHERE THEY TELL THE VOTERS THEY ARE NOT LIKE THE GUY THEY'RE RUNNING AGAINST. SO THAT TENDS TO DILUTE THE INCENTIVE FOR COOPERATION I THINK ALL THE RULES I LEARNED IN POLITICS HAVE BEEN UP ENDED IN THE LAST YEARS BUT THESE ARE FACTORS TO KEEP IN MIND AS YOU WATCH THE GATES. >> TERRIFIC, THANKS, ADRIAN AND THANKS, NEIL. LET'S OPEN THE FLOOR TO QUESTIONS ABOUT THESE ISSUES OR ANYTHING ELSE THAT'S ON THE MIND OF THE ACD. JOSƒ. >> ONE QUICK QUESTION, WHAT IS THE LATEST ON THE TIME LINE FOR SENATOR ELECT JONES TO TAKE HIS SEAT AND BE ABLE TO VOTE? >> THERE'S A LOT OF PEOPLE INTERESTED IN THAT QUESTION AND THE MAJORITY LEAD IS MOST INTERESTED. THIS SAY SEAT FLIP. SO RIGHT NOW McCONNEL CAN LOSE TWO VOTES AND STILL HAVE A MAJORITY. HE SECRETARY OF STATE IN ALABAMA HAS SAID IT WILL CERTAINLY HAPPEN BY DECEMBER 26 BUT THERE'S NO NEWS ABOUT WHETHER THEY CAN GET IT DONE FASTER. >> I APPRECIATE THE INFORMATION ON INDIRECT COST RECOVERY. I WANTED TO ASK YOU THE QUESTION BECAUSE I KNOW YOU HAD PERSONAL CONVERSATIONS WITH MR. MULVANEY AND IN DOING THE EDUCATION OF THE INDIRECT COST AND WHY IT'S SO ESSENTIAL SO WHAT'S YOUR THOUGHT WHETHER THIS MAY COME BACK IN ANOTHER BUDGET IN SAY 2019 BECAUSE IT'S A LOT OF MONEY AND IT'S ABSOLUTELY ESSENTIAL FOR THE RESEARCH INFRASTRUCTURE. THE SHORT IS WE DON'T KNOW. THE CONGRESS SPOKE ABOUT THEIR DISAPPROVAL IN WHAT'S IN THE PRESIDENT'S BUDGET FOR 2018. AND MORE DRAMATICALLY THAN I'VE SEEN IN OTHER TIMES INSTRUCTED NIH TO NOT CHANGE THE WAYS OF CHANGING THE -- I THINK IT'S GOING TO BE INTERESTING TO SEE WHEN THE PRESIDENT'S BUDGET FOR '19 ROLLS OUT IN FEBRUARY WHETHER THERE'S SOME ECHO OF THIS AND THAT'S A PROCESS THAT IS HELD DEEPLY CONFIDENTIAL BEHIND ALL KINDS OF CLOSED DOORS. >> I AGREE WITH WHAT YOU SAID. >> I WAS WONDERING IF WE CAN HAVE COPIES OF YOUR PRESENTATION. AND MY QUESTION IS IF YOU LOOK AT THE PROPORTION OF THE BUDGET WHICH IS NOT PART OF NEW INITIATIVES WHEN WE GENERATE A CURVE OF WHAT I PREDICT WILL BE A DRAMATIC REDUCTION, WE HAD ONE EARLIER AND IT PROBABLY CONTINUES. WE HAVE THIS FALSE SENSE OF SECURITY AND WE'VE ADDED AND I'D LIKE TO SEE WHAT THE PROSPECTS ARE. >> A COUPLE THINGS TO MENTION IT DEPENDS IF YOU LOOK AT NOMINAL OR REAL DOLLARS. WE'LL LOOK AT IT IN TERMS OF WHAT'S THE IMPACT ON REAL DOLLARS. I WOULD SAY THAT HAVING HAD $2 BILLIONS INCREASES IN A ROW WITH A POTENTIAL THIRD THAT HAS A SIGNIFICANT IMPACT IN TERMS OF REAL DOLLARS. AND WE HAVE GAINED ABOUT 2% PER YEAR. IF WE CAN CONTINUE ON THAT TRAJECTORY WE HAVE GAINED THOSE INCREASES. THAT SAID, AS YOU MENTIONED, SOME IS TARGETED FOR PARTICULAR INITIATIVES. AND WHEN YOU TAKE THOSE OUT DEPENDING ON WHETHER YOU'RE LOOKING AT THE HOUSE OR SENATE OR WHATEVER, IT'S BEEN APPROXIMATELY A 3% GENERAL INCREASE IN RECENT YEARS WITH THOSE KINDS OF FUNDING LEVELS, WHICH AT THE MOMENT IS BETTER THAN INFLATION BUT NOT EVERY YEAR. >> I THINK THE COMMUNITY WOULD LIKE TO SEE THOSE DATA. >> I ALSO THINK TO KEEP IN MIND WE TALK PRETTY -- WE FLIP BACK AND FORTH EASILY BETWEEN NOMINAL AND REAL DOLLARS. IN CONGRESS THEY TAKE IT PERSONALLY WHEN YOU SAY WE CUT OVER A NUMBER OF YEARS. OWE THEM I'M NIH WAS ACTUALLY CUT WAS IN 2013 WITH SEQUESTER. SO WE DID LOSE PURCHASING POWER IN A MAJOR WAY BUT WE HAVE TO BE CAREFUL AS WE TALK TO THE PUBLIC AND PRESS AND CONGRESS ABOUT THOSE DISTINCTIONS. >> UNTIL THIS MORNING I THOUGHT GOVERNMENT HAD THE SAME AMOUNT OF MONEY OF THE PREVIOUS YEAR BUT YOU MENTIONED IT'S LESS, 6.WILL 8 6.8% IT DOESN'T SOUND LIKE A LOT BUT WHEN YOU TALK BILLIONS OF DOLLARS IT'S A LOT. >> THAT'S A RESULT OF WHAT ADRIAN WAS TALKING ABOUT THOSE DIFFERENCES BETWEEN WHAT THE CAP SAYS AND WHAT WAS SPENT. CONGRESS HAS WAYS OF SPENDING MORE ON THE DISCRETIONARY SIDE THAN CAP LEVELS. WHEN THEY'RE TRYING TO DO CR AND WANT TO BE ABLE TO SHOW IT WILL NOT RESULT IN A SEQUESTER THEY MAKE THOSE SMALL REDUCTIONS TO TRY TO DEAL WITH IT. >> SINCE THE DISCRETIONARY SPENDING BUDGET IS SMALLER THAN THE WHOLE BUDGET BY A LOT, CAN YOU YOU GIVE A SENSE OF THE INERTIA OF POSITIVE OR NEGATIVE THINGS GOING ON IN THE NON-DISCRETIONARY SIDE AND WHETHER OPTIMISM ABOUT THE ECONOMY OR PEOPLE GETTING JOBS OR ANYTHING HAS ANY MAJOR IMPACT OR WHAT KIND OF TIME SCALE -- MAYBE IT DOESN'T -- >> THE PRESS REPORTS ARE THAT AND HISTORY SUGGESTS SPEAKER RYAN IS VERY INTERESTED IN LOOKING AT ENTITLEMENTS. THERE'S A NUMBER OF DEFICIT HAWKS NOT PLEASED WITH THE WAY IT'S GOING AND IF THERE'S A TWO-YEAR BUDGET DEAL THAT INCREASES THE DISCRETIONARY CAPS THERE'S GOING TO BE A RENEWED FOCUS ON ENTITLEMENT CHANGES. THOSE ARE ALWAYS THORNY. THERE IS AN EXPIRATION, LIKE I SAID, OF THE CHILDCARE PROGRAMS. SO THERE MIGHT BE SOME DEADLINE THEY HAVE TO MEET WHERE THEY HAVE TO TAKE SOME ACTION BUT IT IS CERTAINLY ALWAYS EASIER TO DO NOTHING THAN SOMETHING. DOES THAT ANSWER YOUR QUESTION? >> YES. DIFFICULT QUESTION TO ANSWER. >> SO THE POTENTIAL STRIKING OF THE TAX WAIVER ON GRADUATE STUDENTS IS STRIKING FEAR ACROSS THE COUNTRY. I WAS CURIOUS, I HEARD MOVEMENT ON THAT ISSUE AND WANTED TO HEAR IF THAT WAS TRULY DEAD OR HAS A CHANCE OF COMING BACK. >> WE'LL SEE WHEN WE SEE THE TEXT OF THE DEAL. THE REPORTS WE HAVE FROM PEOPLE THAT HAVE BEEN BRIEFED IS THE PROVISION IS NO LONGER IN THE TAX BILL. THE ATTENTION STUDENTS BROUGHT TO THIS CONVERSATION AND UNIVERSITY PRESIDENTS BROUGHT TO THE CONVERSATION WAS WELL PLACED AND HEARD. >> SEVERAL GRADUATE STUDENTS GOT ARRESTED OUTSIDE PAUL RYAN'S OFFICE. >> A TIME-HONORED TRADITIONAL. >> HOW DO YOU THINK THE DEAL WOULD IMPACT WHAT WAS ORIGINALLY RECOMMENDED IN THE HOUSE FOR THE BUDGET AT NIH. DO YOU THINK THE ONE IN TWO RECOMMEND ATIONS COULD BE AFFECTED IN THE BUDGET DEAL? >> I THINK IT REQUIRES A BUDGET DEAL. I THINK NO MATTER WHAT THE BUDGET DEAL IS, ASSUMING IF WE HAVE A BUDGET DEAL, WE'RE LIKELY TO GET THE INCREASES IN THE HOUSE AND SENATE BILL. THE HOUSE AND SENATE APPROPRIATIONS BILLS WERE NOT WRITTEN TO THE CAPS. SO APPROPRIATORS HAVE BEEN TELLING THEM WE'RE NOT LIVING UNDER THEM AND WRITING BILLS WITH OUR NAME ON THEM THAT GO TO THIS CAP. SO THEY'VE BEEN CLAMORING FOR A DEAL SINCE FEBRUARY OR MARCH. SO THOSE BILLS ASSUME A BUDGET DEAL. >> I WOULD JUST ADD THE GOOD THINGS ABOUT THE HOUSE AND SENATE MARKS THAT I SHOWED YOU I WOULDN'T CALL THOSE TYPICAL OF THE BILL OR THE GOVERNMENT AT LARGE, PERHAPS EXCEPT FOR DEFENSE. I WOULDN'T WANT YOU TO GET THE IDEA IF THE CAPS GO UP, THAT MEANS NIH COULD RECEIVE MORE THAN $2 MILLION. THE CHANCES ARE THOSE BENEFITS WOULD BE SEEN MORE ELSEWHERE IN THE GOVERNMENT BUT WOULD FACILITATE THE GOOD THINGS CONGRESS HAS BEEN TRYING TO DO FOR NIH. >> ASSUMING THE TAX REFORM BILL GOES THROUGH AND BECOMES AN ACT, WOULD IT BE TOO MUCH OR UNREASONABLE TO HAVE SOME SORT OF PROJECTING IN LOOK AT HOW REVENUES COULD AFFECT FUTURE BUDGETARY DECISIONS FOR THE NIH AND ACD, FOR EXAMPLE. >> WELL, I THINK WE COULD DO A SHORT LOOK IN THE FUTURE. INSOFAR AS THE DEAL WILL BE A TWO-YEAR DEAL AND THE LOWER CAPS WOULD KICK IN. THE DEFICIT WILL DO WHATEVER THE DEFICIT DOES. THE ECONOMY WILL DO WHAT IT DOES. WHAT THAT HAS AN IMPACT ON IS TE DEBT CEILING MORE SO THAN THE DISCRETIONARY SPENDING. I WOULD EXPECT WE'LL CONTINUE TO SEE THESE TWO-YEAR DEALS. SO WE LIVE TWO YEARS AT A TIME. BUT I'LL TRY. >> YOU ASSUME THE GOVERNMENT PLANS A 10-YEAR CYCLE WHEN IT'S LESS. WOULDN'T WE REALLY LIKE TO BE ABLE TO MAKE PLANS ABOUT SCIENTIFIC RESEARCH WHICH HAS CYCLE TIMES OF THREE AND FOUR YEARS AND MANY LONGER WITH ASSURANCES WHAT THE TRAJECTORY WILL LOOK LIKE. I'M SURE WE WOULD BUT THOSE AREN'T THE CARDS WE'VE BEEN DEALT. I WILL SAY BEFORE WE CLOSE DOWN, THE SUPPORT WE SEEN FROM THE CONGRESS AND THAT'S IN BOTH PARTIES IN BOTH HOUSES FOR MEDICAL RESEARCH AS A PRIORITY IS REALLY SOMETHING THAT WE SHOULD ALL EXPRESS THANKS TO WHEN YOU CONSIDER IN '16 COMING UP WITH A $2 BILLION AND IN '17 AN INCREASE AND THE CHAIR THEN HOUSE SAYS THEY WOULD LOVE TO MATCH THE SENATE NUMBER ROY BLOUNT HAVE COME UP WITH AND THEY'RE WORKING TOGETHER WITH IT IN AN EFFECTIVE WAY. IT GOES TO THE BASE. WHEN YOU SEE A $2 BILLION INCREASE, THAT WAS $20 BILLION IF YOU WANT TO TALK ABOUT A TEN-YEAR. IF WE GET THE THIRD YEAR, WHICH ALL OF US ARE HOPEFUL OF, IT MEANS WE ENDED WITH A PLUS-UP OF $6 BILLION THAT'S 20% IN THE SPACING OF THREE YEARS WHICH IS A REMARKABLE TURNAROUND WHICH WAS A GRADUAL LOSS OF PURCHASING POWER AS YOU HEARD ABOUT. THAT IS SOMETHING WE SHOULD NOT BE SHY TO EXPRESS TO MEMBERS OF CONGRESS OUR APPRECIATION FOR BECAUSE THAT WAS A LOT OF HARD WORK BY A LOT OF PEOPLE TO MAKE THE CASE AS COMPELLING AS IT HAS BEEN. >> AND I THINK THEY GET A LOT OF KUDOS FOR THE CURES LEGISLATION BUT NO LESS IMPORTANT THAN THE MONEY THAT GETS INVESTED IN OUR BASE. I THINK THAT GETS TALKED ABOUT A LITTLE LESS. >> THE WHOLE CURES BILL WAS OVER $4.8 BILLION FOR THE 10-YEAR PERIOD. WHAT APPROPRIATORS DO IS ADD TO THE BASE. YOU CAN SEE HOW THAT MULTIPLIES. >> IN CONNECTING THE ISSUES, YOU DO A GREAT JOB LINKING THE ISSUES AND SHOULD EXPAND MORE IN WHAT'S AT STAKE. I THINK YOU LAID A WONDERFUL FOUNDATION FOR US. I WOULD EXPLORE EVEN MORE OF THE NEWS FOR COMMUNICATING PODCASTS AND THINGS LIKE THAT. >> I APPRECIATE YOUR SAYING THAT. WE ARE VERY MUCH WITH THE LEADERSHIP OF JOHN BERKELOW THINKING OF WAYS TO GET OUR MESSAGE OUT AND THE INSTITUTE HAVE SKILLS AND CAPABILITIES IN THAT AREA AREA. >> I THINK WE'LL TAKE A BREAK FOR TEN MINUTES OR SO AND RECONVENE TO HEAR FROM DIANA BIANCHI ON WHAT'S HAPPENING AND LET'S GATHER AT FIVE AFTER 11:00. I'LL INTRODUCE DIANA BIANCHI SHE HAS STEPPED IN WITH GREAT VISION AND HERE TO TELL YOU WHAT SHE'S THINKING ABOUT THESE DAYS. DIANA, WELCOME. >> THANK YOU, AND LARRY FOR INVITING ME TO SPEAK ON BEHALF OF THE NICHD. I ASSUME MOST WEREN'T ON THE COMMITTEE SIX YEARS AGO. MY CHALLENGE -- >> I WAS. EVERYBODY ELSE JUST FEELS LIKE THEY WERE. MY CHALLENGE IS TO TELL YOU WHAT WE'RE DOING AND WHAT OUR MOST EXCITING SCIENCE IS. MY FIRST CHALLENGE IS CAN SOMEONE SILENCE THEIR KICK CRICKETS. THE FIRST CHALLENGE IS TO EXPLAIN OUR NAME BECAUSE IT IF I WAS THE DIRECTOR OF THE EYE IS IT IT'S CLEAR AND IF I HAVE TWO MEM -- MINUTES WITH A MEMBER OF CONGRESS IT TAKES THAT LONG TO SAY THE NAME. AND EUNICE KENNEDY SHRIVER ESTABLISHED THE INSTITUTE AND HAD A LIFE LONG COMMITMENT TO PEOPLE WITH INTELLECTUAL DISABILITIES. ADVOCACY GROUPS THINK WE'RE THE ADVOCATES OF ALL CHILD HEALTH BUT WE ONLY FUND 18% OF CHILD HEALTH RESEARCH CROSS NIH. THERE'S A LOT OF RESEARCH IN PEDIATRICS IN OTHER INSTITUTES. OUR MISSION IS TO PROMOTE HEALTHY FAMILIES STARTING WITH PREGNANCY. I BET A LOT OF YOU DON'T KNOW A PORTION OF OUR BUDGET GOES TO FUNDING RESEARCH ON ADULTS RECOVERING FROM STROKES, FOR EXAMPLE. IT MAKES IT DIFFICULT TO COMMUNICATE OUR VERY BROAD SCIENCE. SO TODAY, FIRST OF ALL THIS IS THE PAINTING OF A LADY EATING A LETTER IN BLUE, I PICKED VERMEER THERE'S AN EXHIBIT AND I'M A VERMEER SCHOLAR. I HAVE A LIFE-LONG GOAL OF HAVING ALL THE PAINTINGS AND STUDIES THE MEDICAL FINDINGS IN VERMEER AND THE DEBATE IS WHETHER THE WOMEN IN HIS PAINTINGS WERE PREGNANT OR WHETHER IT'S THE CLOTHING OF THE TIME. WHAT I MEAN BY THE DOCENT APPROACH IF IF YOU GO TO A GALLERY SEE 200 PAINTINGS BUT IF YOU GO WITH A DOCENT AND HEAR ABOUT ONE OR TWO OR THREE TOPICS YOU'LL REMEMBER. TODAY I'LL TALK ABOUT NEONATAL HEALTH AND INFO SHARING. FERTILITY IS A BIOMARKER FOR LONG-TERM HEALTH. I'M A NEONATOLOGIST AND SERVED AS A CONSULTANT TO WOMEN AND INFANTS HOSPITAL IN RHODE ISLAND. THERE I HAD TO SEE ADULTS WITH SINGLE GENE DISORDERS BUT PRESENTED WITH INFERTILITY MEN AS WELL AS WOMEN. IT WAS A COMPLETELY DIFFERENT PERSPECTIVE FROM BEING A PEDIATRICIAN AND FOCUSSED ON CHILDREN WITH BIRTH DEFECTS. THESE WERE ADULTS WHO WERE LARGELY MARRIED AND LOOKING TO HAVE A FAMILY AND YET THEY HAD A GENETIC DISORDER. SO I HEARD ABOUT A MAN, FOR EXAMPLE, WHO HAD EXPERIENCED 50 FRACTURES IN HIS LIFE TIME. HE HAD OSTEOGENESIS AND HIS REASON WAS TO PREVENT A FUTURE CHILD TO EXPERIENCE WHAT HE HAD IN HIS LIFE TIME. NOW, OUR PORTFOLIO ENCOMPASSES RESEARCH AND CONTRACEPTION AND INFERTILITY AND FERTILITY AND I'M FOCUS ON ONCOFERTILITY IT WAS MADE POSSIBLE BY MULTI-DISCIPLINARY ORGANIZERS. WE HAD A REGULAR FEATURE CALLED THE VOICE OF THE PATIENT. I HAVE A ONE-MINUTE CLIP WHO SPOKE AT OUR RECENT COUNCIL IN DECEMBER WHO WILL DESCRIBE HER EXPERIENCE. SHE'S A CANCER SURVIVOR. >> CANCER HAD TAKEN MY HAIR, EDUCATION AND CONFIDENCE BUT TO HEAR IT TOOK AWAY MY FERTILITY WAS DEVASTATING. IT WAS AFTER BEING DIAGNOSED WITH PRE-OVARIAN FAILURE WITH SADNESS BUT AT THE SAME TIME WAS GRATEFUL TO HAVE BEEN CONNECTED WITH THE ONCOFERTILITY CON CONSORTIUM. BECAUSE OF THE ONCOFERTILITY CONSORTIUM I HAVE AN OPPORTUNITY TO MAKE MY DREAMS REALITY. >> SO MEGAN IS A TWO-TIME CANCER SURVIVOR. IN HER 20s. THE FOCUS WAS ALWAYS ON SURVIVAL. WE CAN BRING UP THE LIGHTS A LITTLE BIT NOW, THANK YOU. AND SHE WAS TREATED BY THE ONCOFERTILITY CONSORTIUM BY A PROFESSOR OF WOODRUFF UNIVERSITY WHO CONTRIBUTED HER SLIDES. THE CONSORTIUM IS ONE OF EIGHT INTERDISCIPLINARY CONSORTIUM GRANTS AND DEVELOPED MULTI-LINGUAL CELL PHONE APPS AND A NORMAL -- A NATIONAL FERTILITY PRESERVATION HOT LINE. THAT'S HOW MEGAN FOUND OUT ABOUT THIS OPPORTUNITY AND SHE HAS PRESERVED HER PRESENTATION WHICH LASTED HALF AN HOUR. SHE TALKED ABOUT HOW SHE IS ENGAGED NOW AND READY TO BEGIN THINKING ABOUT HAVING A FAMILY AND HOW IMPORTANT THAT IS TO HER. THIS IS AN ISSUE THAT AFFECTS OVER 16,000 WOMEN IN THE UNITED STATES WHO ARE UNDER AGE 45 AT THE TIME OF THEIR CANCER DIAGNOSE. -- DIAGNOSIS. AGAIN, THROUGH MUCH OF THE WORK THAT HAS BEEN COMMUNICATED BY THE WOODRUFF LAB AT NORTH WESTERN UNIVERSITY THERE'S MULTIPLE ISSUES FOR WOMEN, ACTUALLY MEN AS WELL AS, BUT FOR YOUNG GIRLS WHO ARE PRE-PUBERTAL AND WITH MEGAN HER OCYTES WERE PRE PRESERVED BUT WHAT HAPPENS IF THE CANCER INFILTRATED THE OAFRY OVARY. YOU DON'T WANT IT TO RECUR. THE SO THE WOODRUFF LAB IS WORKING ON INNOVATIVE 3-D PRINTED SCAFFOLDS AND HAVE DONE AMAZING EXPERIMENTS LOOKING AT THE ANGLES OF THE SCAFFOLDS, THE SIZE OF THE POROUSITY AND HAVE BEEN ABLE TO SHOW WITH MOUSE MODELS YOU CAN GET OCYTE TO NESTLE IN THE SCAFFOLD AND HAVE MICE GIVE TO WHAT LOOKS LIKE TRANSGENIC PUPS. THE OCYTES WERE TRANSPLANTED FROM A MOUSE AND IT'S BEEN SHOWN TO RESTORE FUNCTION IN AN ENVIVO MODEL. SHE HAS AMAZING ABILITY IN NAMING THINGS AND EVATAR IS AN AVATAR FOR A FEMALE'S SYSTEM AND THIS IS IN THE PRESENCE OF CYCLINE HORMONES AND IT'S CONNECTED TO A HUMAN FALLOPIAN TUBE AND THEY'VE SHOWN THE OAF -- OVARIES WILL CREATE A 28-DAY CYCLE AND THEY CAN BRING THE HORMONES TO THE LIVER. THIS IS VERY INTERESTING IN TERMS OF STUDYING THE FEMALE REPRODUCTIVE TRACT BUT ALSO ALLOWS PRE-CLINICAL TESTING OF DRUGS AND TOXICOLOGY STUDIES. I'LL SHOW YOU IN A FEW MINUTES WHY WE REALLY NEED SOMETHING LIKE THIS. NOW, I MENTIONED THE NATIONAL EYE INSTITUTE HAS EYES, HEART INSTITUTE HAS HEART, LUNGS AND BLOOD. OUR ORGAN IS THE PLACENTA. YOU HEARD FROM MY PREDECESSOR ABOUT THE IMPORTANCE OF THE PLACENTA AND IT WAS HIS VISION TO CREATE A HUMAN PLACENTA PROJECT. MOST PEOPLE DON'T THINK A LOT ABOUT THE PLACENTA. WE WERE ALL CONNECT TO ONE AT ONE TIME. THE PLACENTA IS ALL ORGANS AT ONE TIME IN YOUR DEVELOPMENT. IT'S ESSENTIAL FOR NORMAL HUMAN DEVELOPMENT AND FETAL METABOLIC PROGRAMMING. I ALWAYS ASK PEOPLE IF THEY KNOW WHAT THEY WEIGHED WHEN THEY WERE BORN YOUR BIRTH WEIGHT IS A BIOMARKER FOR YOUR YOUR MOTHER'S PLACENTA HEALTH WAS AND THAT HAS IMPLICATIONS FOR CARDIOVASCULAR IMPLICATIONS AND THERE'S NOVEL, SAFE REAL-TIME WE HAVE NINE FUNDING OPPORTUNITY ANNOUNCEMENTS TO IMAGES AND MANY OTHERS. IT'S A TRULY GLOBAL EFFORT. WE HAVE MOST THE PIs ARE FROM THE UNITED STATES BUT WE HAVE RESEARCHERS FROM CANADA, THE UNITED KINGDOM AND MADE 22 AWARDS SINCE 2015. I'LL TELL YOU ABOUT INITIAL SUCCESSES BEGINNING TO EMERGE. IT'S ONLY BEEN ABOUT TWO YEARS. THERE'S NOW BEEN FOUR ANNUAL HUM HUMAN PLACENTA PROJECT MEETINGS. WHAT'S EXCITING IS YOU SEE MULTI-DISCIPLINARY SCIENCE IN ACTION. HERE'S A RESEARCHER SHOWING SOMEBODY WHAT THE 3-D MODEL OF THE VIRTUAL PLACENTA LOOKS LIKE. IT'S VERY INTERESTING. WE HAVE A LOT OF INTERACTION OVER POSTERS AND WE HAVE CREATED A SENSE THAT PLACENTAL RESEARCH IS INCREDIBLY IMPORTANT. THIS INCLUDES OUR EXTRAMURAL AND INTRAMURAL COMMUNITY. AND A RESEARCHER HAS DEVELOPED A WIRELESS COMPACT WEARABLE DEVICE THAT GOES ON A BELT FOR CONTINUOUS PLACENTAL OXYGENATED MONITORING. IT'S BEING PILOTED AND IT'S ALSO BEING PILOTED ACROSS THE STREET AT WALTER REED MEDICAL CENTER. THE IDEA IS WE CAN USE THIS PORTABLE DEVICE TO GET A REAL-TIME ASSESSMENT, MAYBE EVEN IN THE PATIENT'S OWN HOME HOW THE PLACENTA IS FUNCTIONING. EVEN IN TWO YEARS THERE'S BEEN AN AMAZING AMOUNT. I WAS AWARE OF WHAT WAS GOING ON BECAUSE I AS AN EXTRAMURAL RESEARCHER APPLIED FOR FUND FROM THE HPP. SO I KNEW WHAT WAS THE STATE OF THE ART AND THE ALIGHTING ALLOWS YOU TO SEE THE DIFFERENCE BUT THE RESOLUTION AVAILABLE NOW, YOU CAN SEE THE VESSELS. IF RICK LIFTON IS ON THE PHONE LOOKING AT THIS -- THE CAPACITY TO VISUALIZE THE VESSELS FOR THE FETUS' HEALTH AS A PREDICTOR OF THE MOTHER'S HEALTH YOU CAN LOOK AT THE FETAL ARTERIALS YOU CAN DO QUANT -- QUANTIFICATION AND THIS IS WORK ALREADY ACCOMPLISHED IN THE FIRST TWO YEARS. WHY DO WE CARE? WE WANT TO CONNECT PLACENTAL FUNCTION TO LONG-TERM OUTCOMES. I SHOULD HAVE MENTIONED THE PREVIOUS WORK WAS AT EASTERN VIRGINIA MEDICAL SCHOOL. ELLEN GRANT AT CHILDREN'S HOSPITAL BOSTON IS LOOKING AT THE IMPLICATIONS. SHE'S LOOKED AT TWIN PLACENTAS AND HAS BEEN ABLE TO SHOW THAT THE RATE OF OXYGENATION -- THE WAY THE OXYGEN FLOWS ACROSS THE PLACENTA USING ADVANCED MRI TECHNOLOGIES CAN BE CORRELATED TO PHYSICAL GROWTH OF THE FETUS AS REFLECTED IN BIRTH WEIGHT AND BRAIN VOLUME OF THE FETUS. SHE'S SHOWN THIS IN ESSENTIALLY IDENTICAL TWINS WHO SHOULDN'T HAVE GENETIC DIFFERENCES AND YET THEY HAVE PLACENTAL OXYGEN DELIVERY DIFFERENCES. SO THERE'S AN UNEQUAL PLACENTAL DELIVERY OF OXYGEN AND SHE HASN'T BEEN ABLE TO PROVE IT'S CAUSING DIFFERENCES IN BRAIN FORM BUT SOMETHING YOU WOULD SPECULATE IS ASSOCIATED WITH GROWTH OF THE FETUS AND GROWTH OF THE BRAIN. THIS PAPER WAS SO INTERESTED IT CAME TO THE ATTENTION OF IRA FLATTEAU. IT'S THE FIRST TIME THE PLACENTA WAS DISCUSSED ON SCIENCE FRIDAY AND WE TOOK LIVE CALLS FROM PEOPLE AROUND THE COUNTRY ON THE PLACENTA. I WAS SURPRISED, ACTUALLY, HOW SOPHISTICATED MOST PEOPLE AND MANY WERE MEN, INTERESTINGLY, WERE SPEAKING ABOUT THEIR WIFE'S EXPERIENCES DURING THEIR PREGNANCIES. IT WAS A LITTLE NERVE-RACKING BUT EXCITING AND IF YOU TYPE IN SCIENCE FRIDAY YOU CAN HEAR THE WHOLE SEGMENT. ANOTHER WAY WE'RE USING STATE OF THE ART TECHNOLOGY TO UNDERSTAND THE PLACENTA IS TO USE CROWD SOURCING. PRIOR TO MY TIME THERES WITH A SENSE WE DIDN'T KNOW A LOT ABOUT TYPICAL PREGNANCY BUT WHAT CONSTITUTES A TYPICAL PREGNANCY. A CROWD-SOURCING APPLICATION HAS BEEN DEVELOPED AND IT'S LIVE. WOMEN WHO ARE PREGNANT CAN PROVIDE INFORMATION IN REAL TIME REGARDING SLEEP, EXERCISE, NAUSEA, VOMITING, WHAT THEIR WEIGHT WAS DOING AND IMPORTANTLY, MEDICATIONS. IT'S THE SECOND I'M I MENTIONED THIS AND I'LL TIE IT TOGETHER IN A MOMENT. WE'RE HOPING ANSWERS TO THESE TOPICS WILL HELP BUILD A MORE COMPLETE PICTURE OF WHAT CONSTITUTES NORMAL PREGNANCY AND DEVELOP STRATEGIES FOR IMPROVING MATERNAL CARE. THIS HAS BEEN LED BY A NUMBER OF FOLKS AT NICHD AND THERE'S BEEN OUTREACH TO INTERNAL AND EXTERNAL PARTNERS. THE PROFESSIONAL SOCIETIES WERE HONORED AT OUR CEREMONY AND BECAUSE OF THAT THEY ALL CAME BECAUSE OF THAT WE HAD QUITE A LOT OF TWITTER ACTIVITY STATING ALL THESE ORGANIZATIONS ARE VERY HAPPY TO BE SUPPORTING US IN OUR PREG SOURCE EFFORTS. IT'S VERY EXCITING AND IT'S LIVE SO MANY ARE GOING ONLINE. YOU HEARD WITH THE CURES ACT. ONE AREA WHERE WE HAVE VIRTUALLY COMPLETE RESPONSIBILITY IS INTERSECTION 2041 OF THE CURES ACT WHICH IS THE TASK FORCE ON RESEARCH SPECIFIC TO PREGNANT AND RACK -- LACTATING WOMEN. IT WAS DELEGATED TO NIH AND WE ASKED AN OBSTETRICIAN TO LEAD THIS TASK FORCE AND IT HAS BEEN VERY PRODUCTIVE SO FAR. THE GOALS ARE TO ANALYZE EXISTING EFFORTS AND UNDERSTAND THE HEALTH EFFECTS ON LACTATING WOMEN AND RELATED BIRTH AND PEDIATRIC OUTCOMES. THE IDEA IS TO SEE WHAT OPPORTUNITIES THERE ARE FOR RESEARCH COLLABORATION AS WELL AS ETHICAL ISSUES SURROUNDING THE INCLUSION OF LACTATING WOMEN IN CLINICAL RESEARCH AND DEVELOP EFFECTIVE COMMUNICATION STRATEGIES WITH HEALTH CARE PROVIDERS AND THE PUBLIC. WE'RE SCHEDULED TO HAVE FOUR MEETINGS. CATHY HAS DONE A SUPERB JOB LEADING THE TASK FORCE MEMBERS. WE HAVE MULTIPLE MEMBERS AND INTERESTED OUTSIDE PARTIES. WE WILL HAVE TO SUBMIT A TO THE DIRECTOR OF HEALTH AND HUMAN SERVICES IN 2018. WHAT HAS BEEN SHOWN SO FAR HAS BEEN SURPRISING. THIS WAS A CHART PUT TOGETHER FOR OUR FIRST MEETING LOOKING AT CONDITIONS THAT PREG NAN WOMEN EXPERIENCE AND FOR WHICH THEY ARE TAKING COMMON MEDICATIONS. SO WE LOOKED AT HYPERTENSION, MENTAL HEALTH ISSUES, PAIN, PRE-TERM LABOR AND SUBSTANCE ABUSE. LOOKING AT BASIC RESEARCH, PHARMACOKINETICS AND THERE'S LITTLE INFORMATION ON PHARMACO INFORMATION. IT'S MORE SHOCKING FOR LACTATION. THIS IS A DIFFERENT STUDY. THE PREVIOUS STUDY LOOKED AT NIH FUNDED STUDIES. THIS IS LOOKING AT INTERVENTIONAL TRIALS AND WE DO HAVE REPRESENTATIVES FROM INDUSTRY ON THE COMMITTEE. THIS SLIDE WAS MADE BY CHRISTINA RETWIG AT NOVARTIS. THE GRAY INDICATES THE COMPLETED TRIALS. THE ORANGE ACCOUNTS THE SUSPENDED OR WITHDRAWN TRIALS. THE BLUE ARE TRIALS THAT ARE ACTIVE. SO THERE ARE TRIALS GOING ON. WE'RE TRYING TO GET MORE INFORMATION BUT THERE'S NOTHING ON BREAST FEEDING FOR WOMEN TAKING MEDICATION. WOMEN CAN EITHER BREAST FEED AND CONTINUE TO TAKE THEIR MEDICATIONS BUT BEING TOLD BY THEIR OBSTETRICIAN AND PEDIATRICIAN YOU'RE AT RISK OF AN UNKNOWN COMPLICATION OR BREAST FEED AND NOT TAKE MEDICATION AT THE RISK OF THEIR OWN HEALTH OR NOT PRIEST FEED AND TAKE THEIR MEDICATION. IT'S A COMPLICATED SET AND IT'S A HUGE TASK. I WANTED TO MOVE TO THE LAST PART WHICH INVOLVES GENOMICS AND THOSE WHO KNOW ME KNOW I'M PASSIONATE ABOUT REPRODUCTIVE GENOMICS AND IT'S THE SUCCESS OF GENOMIC MEDICINE HOWEVER, THERE'S A GAP. TO DATE THERE HASN'T BEEN STUDIES ON PRENATAL GENOMICS AND INDUSTRY HAS TAKEN THE BALL WITH RESEARCH AND ALREADY TREMENDOUSLY IMPACTED CLINICAL CARE. CLINICAL UTILITY WAS SHOWN IN THAT ALMOST 7 MILLION WILL TO DATE WILL HAVE PRETESTING FOR GENETIC TESTING USING DNA CIRCULATING IN THEIR BLOOD. THERE'S NO OTHER TEST THAT HAS BEEN INCORPORATED OVER A PERIOD OF SIX YEARS SINCE IT'S BEEN AVAILABLE TA HAS TAKEN OFF LIKE THAT. FURTHERMORE, IT HAS SIGNIFICANTLY REDUCED THE NUMBER OF INVASIVE PROCEDURES THAT ARE USED FOR DIAGNOSTIC PROCEDURES AND IT LED TO A NUMBER OF MATERNAL CONDITIONS INCIDENTALLY DETECTED BY THIS NON-INVASIVE TESTING. IT'S ONE OF THE MOST COMPELLING PIECES OF EVIDENCE THE LIQUID BIOPSY WORKS. BECAUSE OF THIS GAP AREA IN REPRODUCTIVE AND NEONATAL GENOMICS WE HAVE A PARTNERSHIP TO EVALUATE ADVANCES IN THESE AREA AND WE HAVE A SPRING WORKSHOP PLANNED FOR 2018 BUT WE HAVE A PARTNERSHIP WITH AN NHGRI WITH A CONSORTIUM AND THERE ARE FOUR GROUPS INVOLVED. THEY'RE ALL DOING SOMETHING SLIGHTLY DIFFERENTLY. ONE LOOKS AT SICK INFANTS IN THE INTENSIVE CARE UNIT AND THEY'RE DOING WHOLE GENOME SEQUENCES AND THERE'S BLOOD SPOTS USING WHOLE EXOME CONSEQUENCES. THEY HAVE COMBINED DATA SHARING AND COMBINED ETHICAL ISSUES AND OTHER ACTIVITIES. THE MAIN QUESTIONS BEING ADDRESSED FOR THE STUDY FOR DISORDERS CURRENTLY SCREENED IN NEWBORNS, HOW CAN GENOMIC SEQUENCES REPLICATE OR AUGMENT SCREENING RESULTS. WHAT KNOWLEDGE ABOUT CONDITIONS NOT CURRENTLY SCREENED FOR IN NEWBORNS CAUGHT SEQUENCING PROVIDE AND WHAT ADDITIONAL CLINICAL INFORMATION CAN BE LEARNED FROM GENOMIC SEQUENCES KNOWN TO CLINICAL CARE. JOSLIN KAISER WAS SKEPTICAL THIS FALL WHEN SHE WROTE A LITTLE ARTICLE ON BABY GENOME SCREENING NEEDS MORE TIME TO GESTATE. WHY WAS SHE SKEPTICAL? INITIAL DATA COMING OUT SHOWS THE EX OME SEQUENCE WE HAVE A FUNCTION FUNCTION FUNCTION FUNCTIONAL ASSAY IN PLACE AND THE GROUP IN NORTH CAROLINA LOOKED AT FUNCTIONING BIOMEDICAL TESTING AND COMPARING IT HAVE SHOWN THERE'S CONCERNS ABOUT FALSE NEGATIVES. THESE ARE TAKING BABIES KNOWN TO HAVE A BIOCHEMICAL DISORDER AND THEN DOING THE SEQUENCING SO IT MISSES SOME OF THEM. HOWEVER, IT'S LIKELY THE SEQUENCING WILL DO A BETTER JOB IN EVALUATING THE FALSE DIAGNOSIS. CURRENT SCREENING HAS SOME SAY UNACCEPTABLE HIGH FALSE RESULTS. ONE WAY THE SEQUENCING WOULD BE USED IS IN A TWO TIER PROGRAM. IT'S ALSO BEEN SHOWN SUCCESSFULLY TO AUGMENT NEWBORN SCREENING IN THE SENSE YOU CAN DIAGNOSE THE MUTATION THAT IS CAUSING THE PROBLEM, THE FUNCTIONAL BIOCHEMICAL ABNORMALITY. THE OTHER ISSUE BROUGHT UP IN THE KAISER ARTICLE IS THE RECRUITMENT IS SOMEWHAT LOWER THAN THEY ANTICIPATED BUT THAT DOES SEEM TO DIFFER FROM SITE TO SITE. THIS WAS SPECIFICALLY REFERRING TO THE BOSTON SITE WHERE THOUGH PEOPLE WERE INTERESTED IN HYPOTHETICAL SURVEYS, WHEN IT CAME TIME TO ENROLL IN THE SURVEY THEY WERE ONLY GETTING 7% OF ENROLLMENT AND ENROLLMENT WAS WORSE IN SICK NICU INFANTS IN BOSTON OCCURRED TO THE WORRIED WELL IN BOSTON WHO WANTED INFORMING ON PROSPECT HEALTH CONCERNS FOR THEIR CHILDREN. THAN DIFFERENT. HERE IN SAN DIEGO THEY HAVE AN ACTIVE RAPID DNA SEQUENCING PROGRAM IN CRITICALLY ILL NEWBORNS. IN THAT GROUP THEY GET GET A HIGHER ACCEPTANCE. IN SAN DIEGO THEY HAVE SHOWING THIS RAPID NICU SEQUENCING IS RESULTING IN BETTER DIAGNOSIS, QUICKER AND IMPORTANT DIAGNOSIS IN ACUTE CLINICAL MANAGEMENT. HERE'S ONE EXAMPLE FROM THE GROUP WHERE THEY USED WHOLE GENOME SEQUENCING TO GET AN MPC1 VARIANT IN A SEVEN-WEEK-OLD MALE. YOU DON'T THINK OF IT PRESENTING IN THE NEWBORN PERIOD SO THIS WAS A SURPRISE. IT ENABLED THIS TITLE TO GO IMMEDIATELY ON TREATMENT THOUGHT TO PREVENT ACCUMULATION OF THE AB NORMAL METABOLITES AND RELATED TO A STUDY ON NEIMAN-PICK DISEASE. AND WE SPENDING TIME TO ARCHIVE SPECIMENS AND DIDN'T KNOW WHAT THEY WERE OR WHO CAN USE THEM. WE'RE USING WELL-SPENT CONTRACT MONEY TO GO THROUGH OUR MILLIONS OF ARCHIVED SAMPLES. SOME DATING BACK TO THE 1950s TO SEE DO WE HAVE ADEQUATE CONSENT TO USE THESE SAMPLES, ARE THEY USEFUL, CAN YOU DO A PCR REACTION AND THAT'S ONE SET OF ACTIVITIES GOING ON AND AS SOON AS WE CLARIFY THAT, IN A SEPARATE ACTIVITY, WE HAVE CREATED THE DASH -- THE DATA AND SPECIMEN HUB. WE HEARD IF PEOPLE WANTED SAMPLES THEY CAN GO TO A SITE BUT THEY'D BE BURIED AND WE WANT ONE-STOP SHOPPING AND KNOW WHERE THEY CAN GET DATA OR SPECIMEN. I THINK IT'S OF PARTICULAR IMPORTANCE AND INTEREST FOR YOUNG INVESTIGATORS BECAUSE HAVING MENTORED MANY YOUNG INVESTIGATORS I KNOW THEY SPEND GENERALLY THE FIRST TWO YEARS OF THEIR FELLOWSHIP GETTING THEIR IRB PROTOCOL APPROVED AND THEN WITH PATIENTS. THEY CAN USE THE STUDIES CURRENTLY ONLINE, THEY CAN DOWNLOAD THE DATA. IT'S ALL ETHICALLY APPROVED FOR THEM TO USE AND WE'LL BE LINKING BIOSPECIMENS SOON. SO THIS STARTED IN 2015 AND IT IS RAPIDLY INCREASING. IT'S 50 LAST MONTH AND NOW 53. I GET UPDATES ON THE NUMBER OF STUDIES IN DASH AND THE NUMBER OF USERS. IT'S FREE TO REGISTER AND USE IT. THIS IS 434. PARTLY BECAUSE WE'RE TALKING ABOUT IT A LOT, WE HAVE 434 UNIQUE REGISTRANTS THE PAST MONTH AND QUARTER. MANY PEOPLE COME BACK TO THIS SITE BUT HERE'S ANOTHER VERY EXCITING THING. THIS IS A GLOBAL RESOURCE. SO 10% OF OUR USERS ARE COMING FROM COUNTRIES OTHER THAN THE UNITED STATES INCLUDING LOW AND MIDDLE INCOME COUNTRIES. 35 GROUPS HAVE DOWNLOADED A STUDY ON NORMAL VAGINAL LABOR. SO THAT SEEMS TO BE A SITE OF GREAT INTEREST. SO HERE'S ANOTHER VERMEER PAINTING. IT LIVES IN THE NATIONAL GALLERY. IS SHE PREGNANT OR NOT? WE'RE AT THE FOREFRONT OF NEONATAL HEALTH BUT THE HUMAN PLACENTA PROJECT IS ALREADY DELIVERING IMPACTFUL RESULTS. THERE'S MAJOR GAPS AS A RESULT OF THE TASK FORCE. WE KNOW THERE'S MAJOR GAPS IN UNDERSTANDING DRUG AFFECTS IN PREGNANCY AND LACTATION AND IT'S TOO EARLY TO TELL THE ANALYTICAL VALIDITY AND CLINICAL UTILITY OF NEWBORN DNA SEQUENCING. THESE ARE EARLY DAYS BUT WE ARE ON THE FOREFRONT OF ALL THE ISSUES RELATED TO THIS. OUR VISION IS TO IMPROVE LIFE-LONG HEALTH BY UNDERSTANDING HUMAN DEVELOPMENT AND WE CAN CONNECT ALL THE DOTS USING THAT THEME. IN CLOSING, IF I CAN HAVE THE LIGHTS DOWN ONE MORE TIME, THIS IS TARA SCHAFER A PREGNANCY BLOGGER. SHE EXPERIENCED A LATE STILL BIRTH. SO SHE CAME AND TALKED ABOUT HER EXPERIENCE FINDING OUT HER BABY HAD DIED AND WHAT THAT MEANT. >> IN THE WORK THAT YOU DO, YOU ARE THE FIRST TO GUARD BECAUSE LOVE TO REMEMBER AND IN DOING THE WORK YOU DO YOU ARE REMEMBERING FOR THEM IN TANGIBLE WAYS. ON BEHALF OF PEOPLE, YOU MAY NEVER MEET BUT WHO'S LIVES YOU WILL AFFECT AND CHANGE. AND SO THE MYSTERIES OF THE PLACENTA ARE YET TO BE REVEALED COMPLETELY BUT WHEN THEY ARE, THAT WILL BE A GREAT GREAT OUTCOME. THANK YOU SO MUCH. >> SO I'D LIKE TO THANK YOU FOR YOUR ATTENTION AND I'M HAPPY TO ANSWER QUESTIONS. >> THANK YOU FOR THE OVERVIEW. MY QUESTION IS ABOUT THE THORNY ISSUE OF THE PHARMACOGENETICS AND PHARMACOINFORMATION. WHAT LOOKS PROMISING? >> THAT'S WHY I PUT EVATAR IN THERE BECAUSE I THINK THERE ARE THERE WILL BE IN VITRO SYSTEM THAT CAN GET TO THE ISSUE OF HOW DO THE DRUGS CROSS THE PLACENTA. AND A WOMAN CREATE THE THIS BECAUSE SHE GAVE BIRTH AND HE'S IN THE AGE RANGE AND GOT NO INFORMATION FROM HER OBSTETRICIAN OR PEDIATRICIAN. >> I LOOKED AT IT WHILE YOU WERE TALKING ABOUT IT BECAUSE IT MAY BE THERE'S EXPERIMENTS OF NATURE GOING ON WE CAN HARNESS. WOMEN MAKE THESE CHOICES. I'LL CONTINUE IN MY ANTI-DEPRESSANT AND THEN CAN LOOK AT OUTCOMES IN REAL WORLD DATA. IT'S ONE OF THE USES OF REAL WORLD DATA. >> WE HEARD IN THE TASK FORCE A WEL WELL-INSURED WOMAN FROM NEW YORK WHO SPOKE ABOUT HER EXPERIENCE BEING HOSPITALIZED 72 DAYS BECAUSE SHE'S A TYPICAL MIDDLE-CLASS WOMAN BUT ACQUIRED TUBERCULOSIS AND NO ONE KNEW WHAT TO DO SO SHE WAS IN ISOLATION FOR 72 DAYS BECAUSE NO ONE KNEW WHAT SHOULD BE DONE WITH HER SO IT'S A BIG GAP BUT THANK YOU FOR THE QUESTION. WITH THE NEW TECHNOLOGIES YOU ALLUDED TO AND YOU HIGHLIGHTED THE IMPORTANCE OF CORRELATING IT WITH OUTCOME. IT'S NOT TO FORGET ABOUT INCORPORATING ALL THE NEW TECHNOLOGY IN THE COURSE OF THE LARGE AWARD STUDIES. HAVE YOU STARTED ENGAGING ALL THE ACTIVITIES. >> I BELIEVE OBSTETRICS ARE LINKED AND THE MOST IMPORTANT TIME OF YOUR LIFE IS IN UTERO. WE'RE LINKING THE EXPERIENCE AND PREGNANCY IS A STRESS TEST FOR LATER LIFE PARTICULARLY IN TERMS OF DIABETES AND CARDIOVASCULAR DISEASE AND ALSO FOR THE CHILD. I THINK IT'S ALSO AN OPPORTUNITY AND EVERYBODY'S HEARD ME SAY THIS BUT THE CLINICAL CENTER REALLY COULD THINK A LITTLE BIT OUT OF THE BOX AND BEGIN TO THINK ABOUT ENROLLING PREG NAN WOMEN OUTPATIENT IN STUDIES AND WE HAVE ENORMOUS CAPACITY IN IMAGING. SO DOING SOME IMAGING STUDIES AT THE CLINICAL CENTER AND FOLLOWING THE CHILDREN. I MAKE THE JOKE THAT IF YOU'RE A PREGNANT WOMAN OF SEVEN MONTHS YOU CAN GET ON AN AIRPLANE BUT YOU CANNOT GO IN A CLINICAL CENTER TO HAVE A STUDY. I HOPE WE CAN CHANGE THAT PHILOSOPHY. >> AND YOU'RE WORRIED ABOUT ECHO? >> IT'S USING EXISTING COHORTS TO LINK MUCH OF THIS INFORMATION AS WELL AS ENVIRONMENTAL EXPOSURES WHICH ARE SO IMPORTANT. I KNOW LINDA WAS HERE EARLIER. THERE'S A LOT OF OPPORTUNITIES AND WE ARE WORKING WITH ECHO IMMEDIATELY ON A PROJECT RELATED TO THE NEONATAL OPIOID CRISIS. CLEARLY ECHO IS TAKING LONG TERM BUT MAINLY PEDIATRIC COHORTS NOT NECESSARILY LINKING THE PREGNANCY INFORMATION. > THE INSIDE PROGRAM LOOKS LIKE IT'S POISED TO HAVE LONG-TERM IMPACT. I WONDER IF YOU'LL BE PUTTING IN PLACE THE ECONOMIC ANALYSIS THAT MIGHT BE IMPORTANT TO HAVE A SUSTAINABILITY BEYOND WHAT NIH CAN DO. >> THAT'S A GREAT COMMENT AND I HAD IT IN MY NOTES BUT FORGOT TO MENTION IT. THE PEI AT THE SAN DIEGO SITE HAS REALLY PROMOTED A LOT OF ABOUT THE COST SAVINGS. IF YOU TALK WITH THE DIAGNOSTIC ODYSSEY TALK ABOUT BEING IN AN NICU BED AND I DON'T KNOW WHAT IT COST ANY MORE BUT WHEN I WAS IN MEDICINE IT WAS $1,000 A DAY JUST FOR THE BED AND I'M SURE IT'S MORE THAN THAT NOW. THESE ARE THE KIDS THAT AREN'T NECESSARILY THE PREMIES OR FULL TERM BUT DON'T BREATHE OR DON'T FEED AND THEY SIT THERE FOR MONTHS BECAUSE NOBODY KNOWS WHAT TO DO WITH THEM. JUST THE CASE I SHOWED YOU THE NEIM NEIMANN-PICK DISEASE CASE THEY ESTIMATE THE SAVINGS WOULD HAVE BEEN BECAUSE THE CHILD WAS DIAGNOSED AT SEVEN WEEKS THE SAVINGS WOULD HAVE BEEN 18 $180,000. THERE'S CLEARLY SAVINGS. >> THERE'S QUESTIONS ABOUT FLU AND HERPES VIRUSES. AND IF YOU TREAT WITH ANTIBIOTICS TO PREVENT STREP B IN THE NEWBORN THERE ARE CHANGES YOU CAN OBSERVE AS WELL NOT ONLY IN THE MOTHER WITH RESPECT TO DEPRESSION, POSSIBLY IN TERMS OF INCREASE RISK OF VARIOUS SORTS OF SOCIAL BEHAVIOR DYSFUNCTION. THERE THERE'S A WAY TO INTEGRATE THAT. >> I CAN ONLY HIGHLIGHT BRIEF AREAS BUT WE ARE FUNDING GRANTS LOOKING AT THE EXPOSE AND WITH AUTISM THAT'S AN AREA A NUMBER OF US HAVE BEEN INVOLVED IN IN RESPONDING TO PUBLIC INQUIRIES STILL IN TERMS OF VACCINES AND POTENTIAL CONNECTION TO AUTISM. IF NOT, VACCINES AND OTHER EXPOSURES AND THE CONNECTION WITH AUTISM. MAYBE WE DON'T WANT TO GO THERE BUT I'LL LEAVE IT TO FRANCIS TO DECIDE. >> THE BOSTON RESULT ON THE NICU INVOLVEMENT SEEMS LIKE AN OUTLIER FROM WHAT I HEARD FROM OTHER PLACE. I WONDER IF YOU HAVE INSIGHT TO WHAT MIGHT EXPLAIN THAT AND TO THE POINT OF THE RAPID INDUSTRY-DRIVEN TAKEOVER WITH DNA, LOOKING FORWARD IT LOOKS LIKE IN SCREENING WITH THE THE BORN SCREENING OR IDF, INDUSTRY SEEMS TO BE MOVING AT A SCARILY FAST CASE. >> THIS IS AN AREA I'VE LIVED BECAUSE IT'S HAPPENED IN THE LAST SIX YEARS. I'LL ANSWER THE SECOND QUESTION FIRST. AT THE FDA I'M NOT ACTIVELY INVOLVED IN THOSE DISCUSSIONS. I THINK THE FDA HAS TAKEN NOTICE THAT THE WAY THIS HAS TRANSFORMED CARE AND THE WAY THE INSURERS TOOK NOTICE TOO AND THE REASON IT GOT INCORPORATED SO QUICKLY FOR THE INSURANCE IN THE UNITED STATES THE INSURERS PAID FOR IT BECAUSE INDUSTRY HAD DATA ON HUNDREDS OF THOUSAND OF WOMEN. TELL US THE SCIENCE THAT WILL INFORM CARE. OUR MISSION IS TO HELP IN THE DECISION-MAKING PROCESSES. THE FIRST QUESTION IS MAYBE UNFAIR, AND I APOLOGIES TO ROBERT GREENE IF HE'S LISTENING, BECAUSE OF A DIFFERENT OPPORTUNITY WE WERE JOINTLY CONSIDERING BACK IN MY ACADEMIC LIFE, I WENT THROUGH THEIR WHOLE PROCESS WITH THEM OF WHAT THEY'RE DOING IN TERMS OF THE QUESTIONNAIRES. AND THEY HAVE A VERY DETAILED PROCESS THEY GIVE TO WOMEN WHO HAVE JUST DELIVERED FOR EXAMPLE. THE AMOUNT OF TIME FOR THE MULTIPLE QUESTIONNAIRES IS MAYBE ONE OF THE REASONS IT DOESN'T HAVE TO DO WITH THE TECHNOLOGY OR CLINICAL UTILITY. IT'S THE BURDENSOME ASPECT OF CONTINUOUSLY FILLING OUT THE QUESTIONNAIRES WHEN YOU'RE DEALING WITH A NEWBORN. >> THANK YOU. THIS WAS INSTRUCTIVE AND I APPRECIATE YOU PUTTING SEVERAL THOUGHTS IN FRONT OF US TO CHEW ON. THAT'S BEEN VERY HELPFUL. I THINK WE SHOULD PROBABLY MOVE ON TO THE HE LA WORKING GROUP UPDATE BUT THANKS FOR BRINGING THAT INFORMATION. EACH TIME WE GATHER AT THE ACD AND HEAR A REPORT FROM THE WORKING GROUP ABOUT PROPOSALS FOR ACCESS. YOU SAW THE GRANDCHILDREN OF HENRIETTA LACKS. I'M HAPPY TO CALL ON LISA COOPER, AN ACD MEMBER WHO IS GOING TO WALK US THROUGH THE SEVEN REQUESTS IS THAT HAVE COME IN THE WORKING GROUP HAS DELIBERATED ON AND HAVE RECOMMENDATION. LISA, THANK YOU FOR LEADING US THROUGH THIS. >> SO IT'S BEEN MY PLEASURE TO SERVE AS CO-CHAIR OF THIS GROUP OVER THE LAST YEAR WITH CARRIE WOLINETZ. SOME MEMBERS ALREADY KNOW ABOUT THIS BUT FOR THOSE WHO ARE NEWER I'LL GO THROUGH THE BASICS OF THE AGREEMENT AND WHAT THE WORK GROUP DOES. FIRST OF ALL THIS IS THE HE LA GENOME DATA USE AGREEMENT AND IT OF THE REQUESTS ALL THAT WANT TO USE IT APPLY FOR ACCESS TO THIS SEQUENCE IN THE DATABASE OF GENO TYPE AND PHENOTYPE AND ABIDE BY THE TERMS IN THE AGREEMENT. FIRST, THE DATA SHOULD BE USED FOR BIOMEDICAL RESEARCH ONLY AND SHOULD NOT INCLUDE THE STUDY OF POPULATION ORIGINS OR ANCESTRY. REQUESTERS ARE NOT TO MAKE CONTACT WITH THE LACKS FAMILY AND TO DISCLOSE COMMERCIAL PLANS AND ACKNOWLEDGE PRESENTATIONS AND TO DEPOSIT INTO THE ENTITY GAP. THE ROLE OF OUR WORK GROUP IS TO ASSURE THAT THEY ARE CONSISTENT WITH THE DATA USE AGREEMENT. WE DON'T EVALUATE THE SCIENTIFIC MERIT OF THE PROJECTS AND THEN WE REPORT OUR FINDINGS TO THIS GROUP AND THEN MAKE RECOMMENDATIONS WHETHER THERE'S CHANGES IN THE AGREEMENT OVER TIME WHICH WE HAVEN'T MADE RECENTLY. THIS IS A PHOTO FROM DECEMBER OF 2014 OF THE WORKING GROUP. AS YOU HEARD FROM DR. COLLINS WE HAVE ONE NEW WORK GROUP LEADER -- I MEAN ONE MEMBER WHO IS A MEMBER OF THE LACKS FAMILY. THIS HAS BEEN A WONDERFUL COLLABORATION AMONG SCIENTISTS AND THIS FAMILY WHICH HAS BEEN SO GRACIOUS IN ALLOWING THE BENEFIT OF THE CELLS OBTAINED FROM THEIR FAMILY MEMBER. THESE ARE THE SEVEN STUDIES NOW AVAILABLE TO ACCESS IN THE REPOSITORY AND DB GAP AND THE INVESTIGATORS WHO HAVE SUBMITTED DATA SO FAR. JUST TO MENTION THE WORK GROUP WAS ESTABLISHED BACK IN 2013. AND WE HAVE THE BIOMEDICAL OBJECTIVES. IT SHOULD NOT BE RELATE TO DETERMINING ANCESTRY OR POPULATION ORIGINS OR PLANS TO DEVELOP INTELLECTUAL PROPERTY AND DO THEY ANTICIPATE OR FORESEE DEVELOPING USING IT FROM THIS RESEARCH AND WOULD THEY AGREE TO NOTIFY NIH IF THEY'RE PLANS FOR IP OR COMMERCIAL PRODUCTS CHANGE. AND ARE THERE PLANS TO PUBLISH OR PRESENT FINDINGS. THE CATEGORIES WE HAVE ARE THE REQUEST IS CONSISTENT. IT CAN BE DETERMINED TO BE INCONSISTENT IF IT DIDN'T MEET A CRITERIA. WE CAN ALSO DETERMINE IT'S CONDITIONAL AND OVERALL IT'S CONSISTENT WITH THE DATA USE AGREEMENT BUT THERE MAY BE ADDITIONAL INFORMATION NEEDED. FOR EXAMPLE, IN SOME CASES THERE'S BEEN A REQUEST FOR A NON-TECHNICAL SUMMARY AND WE GOT INFORMATION THAT IT DOESN'T SEEM IT WOULD BE UNDERSTANDABLE TO PEOPLE OUTSIDE THE FIELD SO WE MAKE A REQUEST FOR THAT SUMMARY TO BE REVISED. AND THERE COULD BE A PENDING STATUS BECAUSE THE REQUEST NEEDS TO BE RE-EVALUATED AFTER THE ADDITIONAL INFORMATION IS OBTAINED. SO HERE'S THE CURRENT STATUS OF REQUESTS EVALUATED BY THE WORK GROUP SO FAR. WE'VE HAD 74 REQUESTS. ONE HAS BEEN DISAPPROVED BY THE NIH DIRECTOR AND SEVEN DISAPPROVED BY NIH STAFF. THE INVESTIGATOR SAID THEY DIDN'T INTEND TO DISSEMINATE THEIR FINDINGS. WE HAVE SEVEN NEW REQUESTS WE'LL PRESENT TO YOU TODAY. IF YOU HAVE QUESTIONS ON THE SCIENTIFIC BE ASPECT I'LL HAVE TO DEFER TO SOMEONE WHO KNOWS MORE ABOUT THE CONTENT OF THE QUESTIONS. THE FIRST ONE FROM THE UNIVERSITY OF GENEVA, THE INVESTIGATOR PROPOSED TO USE THE HE LA GENOME SEQUENCE TO VALIDATE THE HE LA PROTEINS WITH A NEW SOFTWARE THEY DEVELOPED AND TO LOOK AT WHERE THEY CAN IDENTIFY UNSTABLE GENES IN THE HE LA SEQUENCE. THE SECOND IS FROM UNIVERSITY OF CHICAGO FOR INTRATUMOR HETEROGENEITY AND WANT THE DATA TO VALIDATE THEIR COMPUTATIONAL MODEL WHICH RELIES ON SEQUENCING TO CHARACTERIZE SINGLE CELLS WITHIN TUMORS. THE THIRD IS A NON-COATING TRANSCRIPTIONAL LANDSCAPE AND THEY PLANT TO USE THE SEQUENCE TO FIND OUT HOW GENOMIC SEQUENCE AFFECT REGULATION OF EXPRESSION IN RNAs IN CANCER CELLS. THE NEXT ONE FROM CARNEGIE MELON THEY WILL QUANTIFY THE SIMILARITIES AND DIFFERENCES IN 3-D CHROMOSOME STRUCTURES ACROSS DIFFERENT CELLS, TYPES AND DISEASE STATES. AND ONE IN CHINA THE INVESTIGATOR PROPOSED TO INVESTIGATE THE CONTRIBUTION OF COPY NUMBER ABERRATIONS TO CANCER. AND STANFORD UNIVERSITY THEY WANT TO COMPARE IT TO THE GENOME TO SEE IF GENOMIC DIFFERENCES IN HE LA CELLS CAN EXPLAIN THE EXPRESSION OF A SPECIFIC GENE THAT'S IMPORTANT FOR NORMAL BRAIN FUNCTION THAT IS EXPRESSED IN LOW-LEVELS IN HE LA CELLS. AND INVESTIGATORS HAVE CHARACTERIZED THE HE LA PROTEOME. THEY WERE FOUND CONSISTENT WITH THE DATA USE AGREEMENT. WOULD YOU LIKE TO ADD ANYTHING ABOUT THESE SPECIFIC PROJECTS? THE COMMITTEE HAS FOUND ITS RHYTHM AND IT SEEMS TO BE A STRAIGHTFORWARD APPLICATION AND NEED KEEP OUR ANTENNA UP FOR FUNKY USES WHICH DON'T COME UP OFTEN. >> THERE'S BEEN SEVERAL DOWNLOADS. >> ARE THERE ANY QUESTIONS? HEARING NONE THIS IS ONE WHERE WE NEED TO TAKE A VOTE. JAY, I'LL ASK YOU TO BE RECUSED BECAUSE YOU SUBMITTED A NUMBER OFSAMPLES. ON THE BASIS OF AVOIDING A CONFLICT OF INTERESTED. >> THERE'S ONE FOR STANFORD SO IF I VOTE AUDIBLY IT'S FOR ALL EXCEPT THAT ONE. IS THERE A SECOND? ALL RIGHT. ANY DISCUSSION? ALL IN FAVOR, PLEASE RAISE HAND. RICK, ARE YOU THERE? >> YES, I AM. I VOTE AYE. >> THANK YOU. ANY OPPOSED? I DIDN'T SEE ABSTENTIONS. THANK YOU, THE WAY THIS WORKS, I TAKE YOUR RECOMMENDATIONS UNDER ADVISEMENT AND YOU HAVE GIVEN ME STRONG RECOMMENDATION THAT MAKES IT EASY. THANK YOU LISA, CARRIE AND DIANA TOO. THIS SAY REMARKABLE MOMENT OF BRINGING TOGETHER SCIENCE AND REACHING OUT AND IT TOOK US A WHILE TO FIGURE OUT HOW TO MAKE A BETTER GO OF IT THIS TIME. FOR ME THIS RELATIONSHIP THAT'S DEVELOPED WITH THE LACKS FAMILY AND THE THOUGHT PROCESS HAS BEEN ONE OF THE MORE GRATIFYING THINGS I'VE HAD A CHANCE TO DO SO WE'LL KEEP IT GOING. I'VE HAD THE PLEASURE OF INTERACTING WITH THEM ON A NUMBER OF OCCASIONS. THEY'RE VERY MUCH INTERESTED IN SEEING THIS WORK USED TO BENEFIT OTHERS. THEY JUST WANT THE INFORMATION SHARED BACK TO THE COMMUNITY SO PEOPLE CAN BENEFIT. >> WE HAVE REACHED THE LUNCH HOUR, ONLY A COUPLE MINUTES BEHIND SCHEDULE WHICH IS NOT BAD. I THINK WE DO WANT TO HAVE A PHOTOGRAPH BEFORE PEOPLE RUN OFF. WE'LL HAVE TO CAUSE A FEW PEOPLE TO GET UP AND EXIT SO THEY'RE NOT IN THE PHOTO AND THEN LET YOU GO TO LUNCH IN THE CAFETERIA AND WE'LL REGROUP AT 1:00. >> WELCOME BACK EVERYBODY. HOPE YOU GOT A LITTLE RESPITE AS WE SENT YOU OFF TO LUNCH AND NOW BRING YOU BACK FOR SOME IMPORTANT TOPICS. BEGINNING WITH HANNAH VALANTINE, WHO WILL TELL YOU WHAT'S HAPPENING WITH THE ACTIONS OF THE DIVERSITY WORKING GROUP AND OTHER THINGS THAT SHE'S BEEN ADDRESSING SINCE SHE CAME ON AS CHIEF SCIENTIFIC OFFICER FOR WORKFORCE DIVERSITY. LET ME CHECK TO SEE IF RICK LEFTON IS ON THE PHONE, ARE YOU THERE? >> YES I AM. >> HANNAH THE FLOOR IS YOURS. >> THANK YOU VERY MUCH. GOOD AFTERNOON. I HOPE YOU ALL HAD A NICE LUNCH AND SOME FRESH AIR TO TAKE IN THIS EXCITEMENT OF WHAT'S UP HERE NOW. SO IT'S A PLEASURE TO PRESENT THIS ON BEHALF OF THE ACD DIVERSITY WORKING GROUP AND MY CO-CHAIR ROY WILSON WHO IS HERE. SO WHAT I'LL DO IS MAKE THIS PRESENTATION AND THEN ASK ROY TO CHIME IN. BEFORE WE START I NEED TO RECOGNIZE THE MEMBERS OF THE WORKING GROUP AS SHOWN HERE, IN FACT, THIS YEAR, WE HAD QUITE A LARGE TURNOVER WITH PRIOR MEMBERS ROTATING OFF AND A NEW GROUP ROTATING ON. AND OF PARTICULAR INTEREST IN THE FACT THAT WE NOW HAVE PARTICIPANTS IN MEMBERSHIP OF THE WORKING GROUP WHO ARE, I WOULD SAY, A LOT YOUNGER OR RATHER MUCH MORE APPROPRIATELY PUT, CLOSER IN YEARS TO THE POPULATIONS THAT WE ARE TALKING ABOUT THAT ARE STUDENTS, ET CETERA. IN MY WORK, I HAVE REALIZED THE IMPORTANCE OF COLLABORATION ACROSS THE NIH AND I AM PARTICULARLY DELIGHTED WITH THE WORK THAT I'VE BEEN DOING WITH NIGMS AND HAPPY THAT ALLISON GAMI AND JOHN LORSCH ARE HERE AS PART OF THIS PRESENTATION THEY MIGHT WANT TO TALK ABOUT. I ALSO WORK VERY CLOSELY WITH MIKE LAUER AND HIS TEAM IN OER THAT HAVE HELPED ME DEVELOP A LOT OF THESE APPROACHES. SO WHAT I WILL TALK ABOUT, A ARE 3 PARTICULAR AREAS. FIRST OF ALL, YOU HEARD LAST TIME THAT I PRESENTED IN JUNE, WORK THAT THE MEMBERSHIP HAD DONE TO LOOK BACK AND SEE WHAT WE HAD ACCOMPLISHED SINCE GANTHER, AND TO COME UP WITH NEW RECOMMENDATIONS AND I WILL TALK A LITTLE BIT ABOUT THOSE RECOMMENDATIONS AND THE PATH FORWARD FOR THEM. ONE OF THE KEY AREAS IS OF THAT--THE SET OF RECOMMENDATION IS AN ATTENTION TO INSTITUTIONAL CHANGE. YOU'VE ALL HEARD ABOUT THE OLD SAYING, LET'S FIX THE WOMEN BY SENDING US ALL TO MORE LEADERSHIP TRAINING, NOW I THINK WE SHOULD FOCUS ON FIXING THE INSTITUTION. AND THEN THE THIRD PART WHICH IS VERY IMPORTANT IS TO DO WITH NIH'S MORE RECENT FLAGSHIP OF DIVERSITY, THE DIVERSITY PROGRAM CONSORTIUM WHICH ACTUALLY IS FUNDED BY THE COMMON FUND SO THANK YOU JIM ANDERSON FOR ALL THE SUPPORT WE GET FROM YOUR OFFICE AS WELL AND IS ACTUALLY IMPLEMENTED AND RUN BY NIGMS, SO A GREAT DEAL OF COLLABORATION HERE AND THE POINT HERE IS THAT THERE IS--IT'S ENTERING ITS SECOND PHASE AND I'LL BE TALKING ABOUT WHAT WE HOPE TO ACHIEVE THERE. SO HERE THIS IS JUST A SCHEMATIC TO EMPHASIZE AND UNDERSCORE THIS DELIBERATE PIVOT WHICH IS NOT TO SAY WE'RE GIVING UP ALL OF THAT WORK THAT HAS BEEN RELATIVELY SUCCESSFUL IN BUILDING THE PIPELINE, BUT RATHER THAT SAY, THAT WORK NEEDS TO GO ON, WHAT WE NOW NEED TO FOCUS ON INSTITUTIONAL INTERVENTIONS AT AN INSTITUTIONAL LEVEL. WHAT DOES THAT ACTUALLY MEAN? WE CAN DRAW FROM LEARNINGS FROM THE NSF ADVANCE PROGRAM THAT HAS BEEN IN PLACE FOR ABOUT 15 YEARS THAT HAS CLEARLY COME TO THE CONCLUSION OF WHAT IT IS THAT WE NEED FOR INSTITUTIONAL TRANSFORMATION. MUCH OF IT IS BOTH AROUND TRANSPARENCY OF DATA AND ACCOUNTABILITY AND THAT WAS ACTUALLY MEANS IS HAVING SYSTEMATIC WAYS OF REVIEWING THE TRANSPARENCY AND HIRING, PROMOTION, POLICIES, ET CETERA, COLLECTING THE DATA AND PUBLICIZING IT AND NOT ONLY PUBLICIZING IT BUT HAVING ACTION ASSOCIATED WITH THE DATA TO CHANGE WHATEVER INIQUITIES ARE UNCOVERED. A LOT OF THE TIME PEOPLE WILL SAY, YOU KNOW, I'M VERY INTERESTED IN DIVERSITY, BUT I SIMPLY CAN'T FIND THEM. WE'RE ALL FIGHTING OVER THE SAME FEW AND THIS IS--THIS IS THE MAJOR IMPEDIMENT. SO I THINK THAT INSTITUTIONS AND SEARCH COMMITTEES AND A LOT OF DIFFERENT KINDS OF GROUPS NEED HELP. THEY NEED THE TOOLS TO IDENTIFY CANDIDATE EXPTION I WILL BE TALKING A LITTLE BIT MORE ABOUT THAT AND AT THE CORE OF THIS IS DOING WORK, THIS WORK WITH THE SAME SCIENTIFIC RIGOR AS WE DO THE REST OF OUR SCIENCE WHICH INVOLVES RIGOROUS EVALUATION AND THEN PULLING ALL OF THAT AND LINKING IT TO INSTITUTIONAL VALUES AND REWARD SYSTEMS. AND I TOOK TIME TO JUST MENTION THIS BECAUSE AS WE LOOKED AT WHAT WE HAD DONE IN THE ACD DIVERSITY WORKING GROUP, THIS WAS A CENTRAL THEME. WE'VE DONE A LOT FOR THE INDIVIDUAL, WHAT ABOUT THE INSTITUTION? SO THIS IS JUST TO SUMMARIZE THE RECOMMENDATIONS. WE CAME UP WITH 13 RECOMMENDATIONS AND I PRESENTED THEM LAST TIME. I WILL NOT SHOW THEM ALL HERE BUT THEY WERE ESSENTIALLY 2 OR 3 BROAD THEMES. FOR INSTITUTIONAL SUPPORT WE WERE--HAD A LOT OF GOOD DISCUSSION ABOUT HOW WE CAN GET INSTITUTIONS TO PARTNER IN RECRUITMENT AND RETENTION TO REMOVE THIS COMPETITION THAT GOES ON AND USE BEST PRACTICES IN DOING SO. THE SECOND ROUND THERE IS ABOUT DIVERSITY METRICS WHICH SPEAKS TO WHAT I'VE ALREADY MENTIONED ABOUT, INSTITUTIONAL FOCUS ON INSTITUTIONAL TRANSFORMATION SO THAT INSTITUTIONS NOW GET INTO THIS CULTURE OF MEASUREMENT AND ACCOUNTABILITY. THE THIRD AREA THERE IS INSTITUTIONAL BEST PRACTICES, WHAT DO WE MEAN BY THAT? HAVING SYSTEMS IN PLACE FOR EQUITY, HAVING SYSTEMS IN PLACE FOR DEALING WITH IMPLICIT BIAS, EDUCATION, ET CETERA AND HAVING WAYS OF MEASURING THE CLIMATE AND ITS EFFECT ON RECRUITMENT AND RETENTION. THE FINAL KEY THEME THAT EMERGED FROM THAT IS THAT THERE EXISTS A GREAT OPPORTUNITY IN OUR TRAINING PROGRAMS. FOR EXAMPLE, THE T32, AND AGAIN, NIGMS HAS TAKEN THE LEAD ON THIS. IF YOU READ THEIR RECENT FUNDING ANNOUNCEMENT, RATHER BEING INTENTIONAL ABOUT FOCUSING ON DIVERSITY. SO THAT IS SOMETHING THAT I'M SURE ALLISON AND JOHN CAN COMMENT ABOUT. WITH REGARDING RECRUIT--MONITORING AND CAREER DEVELOPMENT FOR RECRUITMENT AND RETENTION A PARTICULAR EMPHASIS THAT CAME OUT OF THIS GROUP WAS THE NEED TO FOCUS ON THAT TRANSITION OUT OF THE TRAINING PERIOD AND INTO SPECIFIC CAREERS. AND IN DOING SO, TO CONSIDER NOT ONLY THE ACADEMIC CAREER AS THE OPPORTUNITY BUT THE RANGE OF CAREERS THAT ARE ESSENTIAL WITH SUPPORTING BIOMEDICAL RESEARCH OF WHICH ARE THERE MANY. IT WAS FELT THAT IN ORDER TO ENABLE THAT TO HAPPEN, IT WOULD REQUIRE EXPLICIT PARTNERSHIPS. PARTNERSHIPS WITH PUBLIC-PRIVATE, INDUSTRY-TECH, BIOTECH, ET CETERA. AND THEN WE TALKED A LOT ABOUT THE NEED FOR NOT ONLY DEVELOPING THESE TOOLS WHICH I ASSURE YOU WE HAVE DEVELOPED, BUT DISSEMIATING THEM AND GETTING INSTITUTIONS TO USE THEM SO THEY CAN IDENTIFY CANDIDATES. WE--ANOTHER IMPORTANT AREA WAS THIS RECOGNIZING THE VALUE OF TEACHING. THE POINT WAS MADE THAT IF YOU LOOK AT THE DATA, YOU WILL SEE THAT IN GENERAL, SCIENTISTS FROM UNDERREPRESENTED GROUPS ARE PARTICULARLY INTERESTED IN ACADEMIC CAREERS WHERE THEY CONTINUE TO BE ENGAGED IN TEACHING AND MENTORING AND AGAIN NIGMS HAS A HALLMARK PROGRAM OF THAT CALLED THE IRACDA PROGRAM AND WHY NOT THINK OF WAYS TO DISSEMINATE THAT. AND ADDRESSING GAPS FOR OTHER UNDERREPRESENTED GROUPS. THIS IS IMPORTANT HERE. THERE WAS A LOT OF DISCUSSION IN THE WORKING GROUP BECAUSE THERE ARE MANY GROUPS FOR WHOM WE DO NOT EVEN HAVE THE DEMOGRAPHIC DATA, SEX GENDER MINORITIES AND I MADE A NOTE OF THEM HERE AT THE BOTTOM NONTRADITIONAL STUDENTS. SHOULD WE--THERE WAS A RECOMMENDATION WE SHOULD BE EXPLICIT IN GETTING THE INFORMATION FROM THE GROUPS AND ADDRESSING GAPS FOR THEM IF IDENTIFIED. SO WHAT I'M SHOWING HERE IS THEN, THE INTERVENTIONS THAT ARE CURRENTLY IN PLACE THAT WE HAVE WORKED ON. IN THE EPITHELIAL RAMURAL PROGRAM, WHICH I WILL JUST TAKE A--INTRAMURAL PROGRAM WHICH I WILL TAKE A MOMENT TO REMIND YOU, THE ORIGINAL ACD SUGGESTED COULD SERVE AS A TEST BED FOR PILOTING NEW PROGRAMS. AND TAKING THAT TO HEART, WE'VE DEVELOPED THIS TOOL, RECRUITMENT TOOL FOR IDENTIFYING CANDIDATES, IT HAS 4 COMPONENTS, AND WE ARE PILOTING THAT WITHIN THE INTRAMURAL PROGRAM TO TEST THE EFFICACY FOR DIVERSIFYING THE CANDIDATE POOL, DIVERSIFYING THE SHORT LIST POOL AND ULTIMATELY HIRING AND RETENTION. WE HAVE ALSO THROUGHOUT LAST YEAR WORKED ON THE ISSUE OF EQUITY AND IN PARTICULAR GENDER EQUITY WITHIN THE INTRAMURAL PROGRAM BECAUSE I REALIZE THAT THIS IS AN ISSUE THAT IS NOT ONLY--IT'S NOT UNIQUE TO NIH, BUT TO OTHER INSTITUTIONS THAT WE SUPPORT. SO HOW CAN WE ACTUALLY PROVIDE TOOLS FOR THAT? AFTER REVIEWING A LOT OF THIS AND A LOT OF WORK, WE SET UP A CENTRAL EQUITY COMMITTEE THAT WILL ACTUALLY BE REVIEWING THIS KIND OF RESULTS AND DATA IN TERMS OF HIRING AND MANY OTHER FACTORS AND GIVING ADVICE TO SCIENTIFIC DIRECTORS AS TO HOW TO CORRECT OBSERVED INEQUITY. AND WE STARTED NEW GRADUATE STUDENT DIVERSITY UNIT PROGRAM BEING THE FEED IN FOR DIVERSITY AMONGST OUR FACULTY. OT EXTRA MURAL SIDE, I'VE TOLD YOU--I'VE TALKED TO YOU SEVERAL TIMES ABOUT THE DIVERSITY PROGRAM CONSORTIUM, BUILD RNICC, WHICH IS SOMETHING I WILL MENTION A BIT MORE. WE HAVE DIVERSITY ADMINISTRATIVE SUPPLEMENTS, THOSE THAT CAN BE USED WHEN A PERSON, AN INVESTIGATOR ALREADY HAS AN RO1 GRANT TO RECRUIT SOMEBODY IN THEIR EARLY CAREER STAGE TO WORK ON THESE GRANTS. THIS PROGRAM ACTUALLY WHEN I GOT HERE WAS--IT WAS RATHER A LOT OF CONCERN AS TO WHETHER IT WAS ACTUALLY EFFECTIVE IN ENHANCING THE DIVERSITY IN THE ACADEMIC CAREERS. AND NIGMS AGAIN DISP SEVERAL OTHER INSTITUTIONS HAVE DONE AN ANALYSIS AND FIND THAT ABOUT 60% THAT WERE SUPPORTED ON DIVERSITY SUPPLEMENTS ARE REMAIN NOTHING ACADEMIA. SO THE THOUGHT IS TO GET MORE THINKING AROUND IT AS TO HOW WE CAN INCREASE OR AUGMENT THAT PROGRAM. GOING BACK TO THE ORIGINAL ISSUE THAT RESULTED IN THESE RENEWED EFFORTS OF DIVERSITY, WAS THE GINTHER REPORLT, WHERE IT WAS OBSERVED THAT AFRICAN AMERICANS WITH RO1 WERE SIGNIFICANTLY LESS LIKELY THAN OTHERS TO HAVE THEIR GRANTS FUNDED. WHAT WE'VE DONE HERE IS A DEEP DIVE INTO THE LIFE SPAN OF AN ENTIRE GRANT APPLICATION TO FIGURE OUT WHERE THE GAPS OCCUR WITH THE GOAL OF CREATING INTERVENTIONS TARGETED AT THOSE GAPS. ESSENTIALLY WHAT WE'VE SEEN IS THAT AFRICAN AMERICAN APPLICANTS TEND TO RESUBMIT LESS OFTEN SO WE HAVE A PROGRAM THERE TO DO IT BUT MOST IMPORTANTLY, EQUALLY IMPORTANTLY IS THE INITIAL CAUSE OR LOWER. COULD THIS BE ACTUALLY IMPROVED BY COACHING FOR GRANT PREPARATION AND WE'RE SETTING UP A RANDOMIZED CONTROL TRIAL TO STUDY THAT. BIAS AND PEER REVIEW REMAINS UNEXPLAINED. THE POTENTIAL, AND I'M GLAD RICHARD NAKAMURA IS HERE, HAVE YOU HEARD FROM HIM SEVERAL TIMES ABOUT A STUDY HE CONDUCTING STOCK EXCHANGE ASK THE QUESTION WHETHER OR NOT WHEN WE ANON MYSELF APPLICATIONS THAT GAP IN FUNDING IS ELIMINATED. AND THEN FINALLY, WHEN ALL IS SAID AND DONE, YOU OFTEN HEAR THE COMMENT THAT YOU KNOW WE HAVE A PROGRAM HERE THAT HAS BEEN HIGHLY EFFECTIVE IN 1 INSTITUTION. WE TAKE IT AND TRY TO REPLICATE IT, IT SEEMS NOT TO WORK VERY WELL. SO WHAT ARE APPROACHES TO DISSEMINATE AND SCALE AND I HAVE AN IDEA AROUND CREATING HUBS OF INFOIVATION THAT MIGHT BE ENGAGED IN THE SCALING EFFORT. LET US NOW TURN TO THE STRATEGIES FOR EN--STRATEGIES TUITIONAL CULTURE CHANGE THAT WE'VE BEEN PILOTING INTRAMURAL AND TO DO THAT, I NEED TO SHOW YOU SOME DATA. IF YOU LOOK HERE WHAT YOU'RE SEEING IS, THIS IS THE DATA FROM FY16 SHOWING MEN AND FEMALE IN TENURED TRACK AND TENURED POSITIONS AND WHAT YOU CAN SEE IS THAT WOMEN COMPRISE NEARLY 25.5%. DOWN HERE WE SEE THE BREAK DOWN BY RACIAL ETHNIC GROUPS, 1.8% AFRICAN AMERICAN, 3.7 HISPANIC AND 0.2% ARE NATIVE AMERICAN. I THINK THAT THOSE DATA THAT ARE AGGREGATED DON'T ALWAYS TELL THE WHOLE STORY BECAUSE WHEN WE WANT TO MAKE INSTITUTIONAL CHANGE, WE HAVE TO GO TO THE VERY UNITS, THE MICROUNITS WHERE THINGS ARE HAPPENING, SO 1 WAY OF DISAGGREGATING NATIONAL DATA NOW IS BY LOOKING AT INSTITUTIONS AND I CAN SEE RUSS SCRUTINIZING VERY RAPIDLY. THIS IS U.S. NEWS AND WORLD REPORT AND DON'T--DON'T BELIEVE IT IF YOU HEAR DEAN SAY THAT THEY DON'T PAY ANY ATTENTION TO IT. THEY DO. WHAT YOU'RE SHOWING HERE IS THE RANKING WITH NUMBER 1 RIGHT UP TO NUMBER 10 HERE. AND WHAT I'M SHOWING IS THE PERCENTAGE OF WOMEN WHO ARE FULL PROFESSORS OR TENURED PROFESSORS. AND WHAT YOU CAN SEE IS THE NATIONAL AVERAGE FOR BOTH FULL AND TENURED IS 23% AND I DON'T NEED TO YOU READ ALL THE NUMBERS. YOU CAN SEE THEM IN YOUR PRINT OUT BUT VERY FEW INSTITUTIONS ACTUALLY EXCEED THE NATIONAL AVERAGE. FOR WOMEN FOR WHOM THERE IS NO EXCUSE--THERE IS NO EXCUSE OF A PIPELINE ISSUE BECAUSE WE KNOW THAT WE'VE BEEN GRADUATING MORE THAN 50% OF Ph.D. RECIPIENTS FOR GREATER THAN 15 YEARS HAVE BEEN WOMEN. SO I PUT UP HERE AT NIH INTRAMURAL PROGRAM BECAUSE I REGARD US TO BE IN THE TOP 10 AT LEAST AND WHAT YOU SEE HERE IS THAT WE HAVE 22% OF WOMEN. SO WE HAVE A LOT OF WORK TO BE DOING. I LOOK AT IT AS ACTUALLY AN OPPORTUNITY FOR CHANGE TO TEST THESE NEW TOOLS THAT WE--WE HAVE DEVELOPED. SO, A LOT OF THIS--THESE BARRIERS CAN BE FRAMED AS RELATED TO THE INSTITUTIONAL CULTURE AND IN ORDER TO CHANGE THAT WHEN WE BECOME AN EN--STRATEGIES TUITION THAT MEASURES THINGS, THAT IS ACCOUNTABLE, THEN WE BEGENERATED TO GET THAT CULTURE CHANGE THAT WE WANT. SO, OUT OF THE COMMITTEE THAT LOOKED SERIOUSLY AT GENDER EQUITY IN THE INTRAMURAL PROGRAM WE RECOGNIZE WE MUST HAVE INSTITUTIONAL FOCUS AND APPROACHES, LEADERSHIP COMMITMENT FOR HIRING AND PROMOTION AND TRANSPARENCY OF THE KIND THAT I'VE ALWAYS--I'VE ALREADY TALKED ABOUT. IN ADDITION THE COMMITTEE HAD REALIZED WE MUST CONTINUE TO HAVE INDIVIDUALLY FOCUSED APPROACHES THAT PROVIDE SUPPORT FOR MENTORING AND ADDRESS THE ISSUES OF INCLUSION AND BELONGING. SO HOW DOES OUR INTRAMURAL DATA LOOK LIKE IN TERMS OF RACE ETHNICITY? AND WHAT I'M TRYING TO SHOW YOU HERE IS THE IDEA THAT IF YOU HAVE A CENTRAL MECHANISM OF HIRING WITH AN OPEN SEARCHES, WIDE RANGE OF SEARCHES, YOU ARE MORE LIKELY TO ENHANCE THE DIVERSITY ULTIMATELY AMONGST THE PEOPLE YOU HIRE. AND BECAUSE OF THAT IN 2010 BEFORE EACH I GOT HERE, NIH INTRAMURAL PROGRAM STARTED THE STADMAN PROGRAM WHICH MICHAEL GOTS--GOTTESMAN IS HERE AND CAN TALK ABOUT, THERE ARE PROGRAM RUN EVERY YEAR, 22 COMMITTEES HIRING AND LOOKING AT CANDIDATES WITH THE HOPE THAT WE CAN BRING IN NEW HIRES HERE. AND SO, IF YOU LOOK AT THE STADMAN SEARCHES HERE AND BREAK DOWN BY RACE ETHNICITY, THE DATA IS CLEAR HERE THAT WE HAVE HIRED 9% OF THE STADMAN HIRES ARE AFRICAN AMERICAN AND THIS IS ANOTHER TYPE OF TRANSNIH SEARCH CALLED THE LASKER SEARCH WHICH IS MORE FOCUSED ON CLINICL INVESTIGATOR RESEARCHERS WHERE AS STADMAN SEARCHERS ARE MORE ON THE BASIC SIDE. BUT THE MAIN POINT HERE IS IF YOU COMBINE THOSE SEARCHES YOU WILL FIND THE DIVERSITY THERE IN THE PEOPLE HIRED IS SIGNIFICANTLY GREATER THAN THOSE HIRES THAT ARE CONDUCTED OUTSIDE OF THE CONTEXT OF THIS. SO WHAT THAT TELLS ME IS THAT THIS KIND OF APPROACH IS SOMETHING THAT PERHAPS OTHER INSTITUTIONS COULD OR SHOULD BE ADOPTING. THIS IS TO SHOW YOU SOMETHING THAT WAS INTENDED TO BUST THE MYTH THAT THERE ARE NONE. WE ARE ALL FIGHTING OVER THEM. WHAT IT DOES HERE IS TO SHOW YOU THE IDEA THAT THE HIRING OF UNDERREPRESENTED MINORITY ASSISTANT PROFESSORS HAS LAGGED CONSISTENTLY BEHIND THE PRODUCTION OF Ph.D. RECIPIENTS AND NIH RELEVANT FIELDS. THIS WORK WAS DONE BY KENNY GIBBS WHO IS AGAIN A COLLEAGUE HERE. WHAT YOU ARE SEEING POPULATION GROWTH ACROSS SEVERAL YEARS. IN THE DOTTED LINEUP YOU SEE HIRING INTO ASSISTANT PROFESSOR AND THE DOLL EDUCATIONAL LINE,--SOLID LINE THE RECIPIENTS OF Ph.D.s AND THE GAP IS ENORMOUS. WHAT THAT MEANS IS THERE IS A DISCONNECT BETWEEN THE 2 SYSTEMS OF DEVELOPINGPh.D.s, ACQUIRING Ph.D.S AND HIRING INTO,A CYST ANT PROFESSOR POSITION. AND THIS IS A-- ASSISTANT PROFESSOR POSITION. AND THIS IS A MARKED CONTRAST FROM THE RED, WHICH W. R. MEANS WELL REPRESENTED AND THE GAP BETWEEN THE HIRING AND TO ASSISTANT PROFESSORS IN THE PRODUCTION OF Ph.D. RECIPIENTS IS MUCH, MUCH, NARROWER. WHAT IT MEANINGS--MEANS IN ACTUAL TERMS IS THAT OVER THE LAST 10 YEARS, WE SHOULD--CAN EXPECT AT LEAST 1700 Ph.D. RECIPIENTS BEING CHURNED OUT EVERY YEAR IN NIH RELEVANT FIELDS AND I EMPHASIZE NIH RELEVANT FIELDS BECAUSE LARRY LOOKED AT THIS DATA INITIALLY AND SAID, ISN'T IT--THE VAST MAJORITY PSYCHOLOGISTS BUT THEY'RE NOT. IF YOU LOOK DOWN HERE, 53% ARE IN BIOLOGICAL SCIENCES AND 19.2% ARE IN CHEMISTRY. SO THE POOL IS THERE AND I WOULD ARGUE THAT MUCH OF THIS POOL RESULTS FROM THE EFFORTS THAT NIH HAS MADE THUS FAR. WE HAVE TO BRIDGE THAT GAP. SO HOW DO WE FIND THESE PEOPLE? AND PRESENT THEM TO SEARCH COMMITTEES? WE STARTED THIS WORK AND WE'VE DEVELOPED A--SOME SEARCH PROTOCOLS TO DO THIS, AND WE'VE PUT IT ALTOGETHER IN THE FORM OF A TOOL KIT WITH THE ASSISTANCE OF ALLISON DAVIDS OVER THERE AND ESSENTIALLY WHAT WE HAVE IN THIS TOOL KIT NOW FOR NIH INTRAMURAL PROGRAM IS CLOSE TO 700 PEOPLE WHO ARE IN THIS EARLY STAGE. THEY'RE DOING WELL IN TERMS OF THEIR SCHOLARSHIP AS NOTED HERE, THEY'RE PUBLISHING IN GOOD HIGH LEVEL PEER REVIEW JOURNALS AND HERE IS THE DEMOGRAPHIC OF THIS POOL WITH 31% BEING AFRICAN AMERICAN AND 25% BEING HISPANIC AND THIS IS JUST THE BEGINNINGS OF THIS. I THINK WE COULD BUILD THIS TREMENDOUSLY BUT THE MOST IMPORTANT POINT OF THE MESSAGE IS THAT ANY INSTITUTION THAT IS TRULY INTERESTED IN DIVERSIFYING THEIR FACULTY COULD GET ON THE WEB LINE, USE THE TOOLS AND IDENTIFY POTENTIAL CANDIDATES AND INVITE THEM TO,A--TO APPLY. FOR THE NIH INTRAMURAL PROGRAM WE ARE HOPING TO TEST A NEW MODEL THAT INVOLVES COHORT HIRING AND THIS IS AN APPROACH THAT HAS BEEN SHOWN IN MANY INITANCES TO BE PARTICULARLY EFFECTIVE IN DIVERSITY. SO WHAT WE HOPE TO DO IS TO IDENTIFY A VETTED TOOL OF SCIENTISTS--POOL OF SCIENTISTS THAT WILL ENHANCE DIVERSITY AND BROADLY DEFINE AND HAVE ALREADY DEMONSTRATED THE TRAJECTORY TO BECOME INDEPENDENT SCIENTISTS. WE WILL EMBED IN THAT PROGRAM STRATEGIES FOR MINIMIZING ELICIT BIAS AND 1 IMPORTANT THING IS TO ACCELERATE THE HIRING PROCESS SO THAT WE REMAIN COMPETITIVE WHILE PEOPLE ARE CONSIDERING OTHER OFFERS. ONCE YOU BRING PEOPLE HERE, YOU NEED A CULTURE OF INCLUSION AND WE WILL DO THAT THROUGH COHORT FOCUSED ACTIVITIES AND WE IN THE SAME TIME MAKING SURE WE'RE EXTENDING A STRONG MESSAGE OF EQUITY WITHIN THIS INSTITUTION WHERE THINGS ARE PRESSURED AND THERE IS A CLEAR MESSAGE THAT A PERSON COMING HERE WILL BE EQUITABLILY TREATED AND THEY WILL HAVE THE OPPORTUNITY FOR ADVANCEMENT. ACTUALLY THIS COHORT MODEL HAS ACTUALLY BEEN--HAS ACTUALLY BEEN TESTED BY NIGMS ALREADY AND THEY HAVE THOUGHTS OF DOING THAT ON A MORE NATIONAL LEVEL AND AGAIN, JOHN, MIGHT BE ABLE TO COMMENT ON THAT. THEN FINALLY LETNY JUST END BY TALKING ABOUT THE DIVERSITY CONSORTIUM PROGRAM. THIS GREW DIRECTLY OUT OF THE INITIAL RECOMMENDATIONS BY THE ACDOT WAKE OF THE GINTHER REPORT. AND IT WAS RECOMMENDED THAT RESOURCES WERE NEEDED TO BE BROUGHT TO INSTITUTIONS THAT WERE RELATIVELY UNDERSERVED AND IN ORDER TO DO THAT, THE CRITERIA FOR ELIGIBILITY WERE VERY CLEARLY DEFINED. EACH INSTITUTION TO BE ELIGIBLE HAD TO HAVE RECEIVED LESS THAN $7.5 MILLION IN RESEARCH GRANTS AND HAVE A 25% STUDENT POPULATION. I MENTIONED THIS BECAUSE I'VE HEARD AS I GO,A ROUND THE COUNTRY, PEOPLE, SENIOR LEADERS PAY NO ATTENTION TO THAT ELIGIBILITY CRITERIA AND MAKE COMMENTS LIKE, WELL, ALL OF THIS MONEY HAS GONE TO RESEARCH INTENSIVE INSTITUTIONS WHICH IS SIMPLY NOT TRUE. IS IT BEING RECORDED? SO, HERE IS, OOTLE AN INTEGRATED SET OF 3 PROGRAMS THAT INVOLVE BUILDING UNIVERSITY--INSTITUTIONS LEADING TO DIVERSITY AND WHAT IT MEANS, WHAT'S GOING ON THERE ESSENTIALLY A SET OF 10 DIFFERENT EXPERIMENTS. WHY? BECAUSE ANOTHER RECOMMENDATION WAS THAT NIH HAD NOT BEEN EFFECTIVE IN EVALUATING IT'S PROGRAMS, PARTICULARLY ITS DIVERSITY PROGRAMS WELL ENOUGH. SO IN RESPONSE TO THIS NEW OPPORTUNITY, ALL OF THESE PRACTICALS ARE DESEENED IN SUCH A WAY THAT THEY CAN BE EVALUATED AND TO THE EXTENT OF HAVING CONTROL GROUPS. THE SECOND COMPONENT IS THE NATIONAL MENTORING NETWORK, THE THIRD IS THE CENTER FOR COORDINATING AND EVALUATION WHERE THINGS WILL BE MEASURED. SO HERE'S THE LIST OF THE 10 BILLED INSTITUTIONS, THAT ARE DOING WORK THAT IS BASED ON HYPOTHESIS DRIVEN WORK AND THEN, THE NATIONAL MENTORING NETWORK WHICH HAS A NUMBER OF CAUSE DESIGNED TO BOTH LINK STUDENTS WITH MENTORS, TO TEACH MENTORS HOW TO BE BETTER MENTORS AND TO PREPARE PEOPLE AND COACH THEM FOR GRANT APPLICATIONS. JUST TO LET YOU--TO SHOW YOU THIS DASHBOARD OF THE KINDS OF ACTIVITIES AND THE VOLUME OF THE ACTIVITIES THAT HAS BEEN OCCURRING. SO THIS PROGRAM IS STRUCTURED SO THAT WE CAN GET DATA THAT ARE STUDENT LEVEL, FACULTY LEVEL AND INSTITUTION LEVEL. LET'S TAKE A LOOK AT THE--AT THE STUDENT LEVEL. HERE, YOU CAN SEE FOR EXAMPLE, THE BILLED NRSA SLOTS THAT HAVE BEEN OVER 1300 BUT THIS NUMBER LOOKS LARGER THAN IT IS SPECIFICALLY FOR BUILD BECAUSE STUDENTS ARE SUPPORTED FOR MULTIPLE YEARS AND I WILL SHOW YOU THE DATA AROUND THE STUDENTS THAT ARE JUST ON THE BUILD PROGRAM. YOU CAN SEE HERE, FACULTY ARE BENEFITING FROM THIS, RELEASE TIME, FACULTY MENTORING, PILOT PROJECTS AND IN FACT, WE WILL BEGIN TO SEE INSTITUTIONAL OUTCOMES LIKE NOVEL CAREER, PARTNERSHIPS, ET CETERA. YOU MIGHT BE WONDERING WHAT THE DEMOGRAPHIC IS, AND THIS IS DEMOGRAPHIC OF THE TL4, THAT'S THE STUDENTS WHO ARE FULLY FUNDED WITH STIPENDS AND REALLY DESPITE THE DEFINITION OF ELIGIBILITY WHICH I ARTICULATED WE'VE ACTUALLY CAPTURING AND REACHING THE DIVERSITY THAT WE HOPED WE WOULD. SO WHAT YOU'RE SEEING HERE 27%, AFRICAN AMERICAN BLACK, 41% HISPANIC. SO, DOING TARGETED POPULATION, I THINK IT'S VERY IMPORTANT TO LOOK INTO NRMN AND WHO IS GETDING THAT GRANT WRITING AND COACHING. SO, TO DATE OVER 400 PEOPLE HAVE PARTICIPATED AND HERE IS THE DEMOGRAPHIC OF THE PARTICIPANT ON THOSE GRANT WRITING PROGRAMS AND WHAT YOU CAN SEE HERE, CAN YOU READ IT FOR YOURSELF, AGAIN, REACHING THE TARGETED POPULATIONS. ONE OF THE PROGRAMS, 1 OF THE ELEMENTS OF THE DIVERSITY CONSORTIUM PROGRAM THAT'S BEEN THE MOST CHALLENGING HAS BEEN THE NATIONAL MENTORING NETWORK AND IN PARTICULAR HAVING A WAY OF RAPIDLY LINKING MENTORS WITH MENTEES ONLINE. BUT THAT THAT HAS BEEN TO A CERTAIN EXTENT TO ADDRESS, AND I DRAW YOUR ATTENTION TO DOWN HERE WHICH IS A NEW WAY OF RAPIDLY MENTORING--MATCHING--MENTORS WITH MENTEES THAT ALLISON AND HER TEAM PUT INTO PLACE WHEN SHE CAME ON BOARD AND REALIZED THAT THE COMPLICATED ALGORITHM THAT HAD INSHALLLY BEEN PROPOSED WAS NOT DOING THE JOB IT REQUIRED. SO NOW NOW 1400 IS PEOPLE WHO HAVE BEEN--HAVE MADE AT LEAST 2 COMMUNICATIONS WITH MENTOR AND MENTEE. SO THEY ARE BEING MATCHED. THEY ARE TALKING TO EACH OTHER AS OPPOSE TO A LOT FEWER UP HERE. AND MATCHING IS ALSO OCCURRING IN THE CONTEXT OF THE GRANT WRITING, JUST TO POINT THAT OUT IN THOSE PROGRAMS, PEOPLE ARE PROVIDED WITH MENTORS. THE CENTER FOR COORDINATION AND EVALUATION WHICH IS THE THIRD COMPONENT THAT WILL COLLECT ALL THIS INFORMATION IS COLLECTING, HAS A DATA TRACKING SYSTEM. AND REALLY THIS IS JUST TO SHOW YOU THE EXTENT OF THE REACH OF ALL OF THIS AND I SHOWED YOU THIS LAST TIME, MENTORING AND THE NUMBER OF PARTICIPANTS IN CAREER DEVELOPMENT, NOVEL CAREER, ET CETERA. AND THIS IS NOT ONLY WHAT THE ECEC WILL PRODUCE, WHAT THE CC WILL ACTUALLY PRODUCE IS A COMPARISON OF INTERVENTION GROUPS WITH CONTROL GROUPS ULTIMATELY. SO WHAT ARE THESE STUDIES OR THESE INTERVENTIONS THAT ARE GOING ON WITHIN BUILD? SO THESE HERE, SOME OF THEM, SOME ARE TESTING STEREOTYPE THREAT, CAN WE DIMINISH THIS FEELING OF IMPOSTER SYNDROME, AGGRESSIONS AND THERE ARE CONSORTIUM WIDE 1S LIKE SCIENCE OR DIVERSITY, DOES FINANCIAL AID MAKE ANY DIFFERENCE IN TERMS OF OUTCOMES. AND SO LET'S JUST LOOK AT THAT, THE MODEL. SO ESSENTIALLY THE WAY THIS HAS BEEN SET UP IS ALMOST LIKE A CLINICAL TRIAL FOR THE TYPE OF STUDY THAT MOST OF US ARE FAMILIAR WITH. SO THE INDEPENDENT VERYIABLES WOULD BE LISTED HERE, RAISE SOCIOECONOMIC STATUS, GP As, ET CETERA, THE ACTIVITIES AND OUTCOMES, FINANCIAL SUPPORT, I MENTIONED ACADEMIC ADVISING AND NOVEL CURRICULAR AND THESE ARE THE KINDS OF PREDEFINED SHORT-TERM OUTCOMES THAT WE ARE LOOKING AT. WE'RE NOT GOING TO LOOK BACK AND DATA DRAG AND SAY WHAT HAPPENED? THESE ARE THE HALLMARKS OF SUCCESS THAT HAVE ALREADY BEEN IDENTIFIED TO WHICH WE WILL BE EVALUATING AND THEN THERE ARE OF COURSE LONG-TERM OUTCOMES SHOWN HERE AND ALL OF THIS IS IN YOUR PACKAGE. I WANT TO GIVE YOU 1 OR 2 EXAMPLES. SO STEREOTYPE THREAT IS A PHENOMENA THAT THE SAN FRANCISCO STATE BUILD IS VERY INTERESTED IN. IT IS THE FEAR OF SUCCUMBING TO A NEGATIVE STEREOTYPE ASSOCIATED WITH YOUR IDEBTITY GROUP. THE CLASSIC AS WAS DESCRIBED INITIALLY WAS MATH, THE STEREOTYPE THAT WOMEN ARE NOT AS GOOD AT MATH AS MEN AND THE INTERVENTION HERE AND SHOWN. THIS IS A 3-PRONGED ARM. YOU HAVE THE URM AND THE NONURM, YOU LOOK AND SEE WHAT THE COURSE GRADES ARE AFTER THE INTERVENTION IN THE VARIOUS GROUPS. AND WHAT IS--WHAT YOU'RE SHOW SUGGEST THAT ABSTRACT GRADES, COURSE GRADES, ABSTRACT REASON AND RESILIENCE, ALL OF THEM IMPROVE WITH THIS INTERVENTION CALLED STEP WHICH IS A COMBINATION OF ALL OF THESE 3. AND THIS ACTUALLY HAS ALREADY BEEN PUBLISHED. HERE IS ANOTHER 1 WHICH IS THE UNIVERSITY OF EL PASO, TEXAS AND THEIR INTERVENTION IS SOMETHING CALLED FRESHMAN YEAR RESEARCH INTENSIVE SEQUENCE WHERE THEY ARE EXPOSED TO THESE VARIOUS COURSES AND WHAT YOU CAN SEE HERE IS THAT THE BUILD FELLOWS HUNDRED PERCENT ARE COMPLETING THAT FRESHMAN YEAR AS OPPOSE TO OTHER GROUPS THAT DO NOT HAVE THE BUILD INTERVENTION WHERE THE COMPLETION RATES ARE LOWER AND THIS IS JUST VERY PRELIMINARY DATA. I THINK WE ALL RECOGNIZE THAT IT'S GOING TO TAKE A WHILE TO ACTUALLY SEE THE DATA AROUND WHO ADVANCES TO PHDs. AND LET ME JUST FINISH ABOUT THE NEW DPC, PHASE 2. SO PHASE 1 WAS FUNDED FOR 5 YEARS. THERE WAS--WE NEEDED TO LOOK TO SEE WHETHER IT WAS MOVING IN THE RIGHT DIRECTION TO DETERMINE WHETHER THERE WILL BE A SECOND PHASE AND OVERALL THE CONSENSUS IS YES. SO AS A CONSEQUENCE OF THIS, THIS NOTICE HAS BEEN PUT OUT JUST LAST WEEK ABOUT WHAT PHASE 2 MIGHT LOOK LIKE. SO THE BUILD IS A LIMITED COMPETITION, LIMITED TO THOSE EMERITORIOUS BUILD SITES THAT ARE ALREADY IN PLACE AND IT'S DESIGNED FOR THEM IT COMPLETE THEIR WORK SO WE CAN ACTUALLY GET THOSE KINDS OF DATA THAT I'VE BEEN TALKING ABOUT. THE FOCUS IS ON SITE SPECIFIC AND CONSORTIUM WIDE EXPERIMENTS AND WE WILL BE REQUIRING THEM TO DISCUSS HOW THEY'RE GOING TO PUT IN SUSTAINABILITY AND DISSEMINATION APPROACHES. THE SECOND THAT WILL BE A LIMITED COMPETITION ALSO IS THE CENTER FOR COORDINATION AND EVALUATION. YOU WILL RECALL THIS IS WHERE ALL OF THIS DATA CONTROLS INTERVENTIONS WILL BE COLLECTED AND THE DATA ANALYZED. THEY SET UP THE SYSTEMS TO DO IT. IT DOESN'T SEEM TO MAKE A LOT OF SENSE TO CHANGE AT THIS POINT BUT THEY WILL BE ALSO ASKED TO SAY HOW THEY'RE GOING TO BE SUSTAINABLE AND DISSEMINATE AND HOW THEY ARE GOING TO IMPROVE THE OVERALL STRUCTURE OF THE PROGRAM. THERE IS A NEW ELEMENT TO THIS WHICH IS CALLED THE DPC DISSEMINATION TRANSLATION AWARD AND THIS IS AN OPEN COMPUTATION TO A--COMPETITION TO ALLOW NEW APPLICANTS AND NEW INSTITUTIONS TO COME IN. THE FOCUS WILL BE ON TRAINING OR MENTORING RESEARCH ADMINISRATION CAPACITY AND AGAIN THE FOCUS IS IMPLEMENTATION AND SUSTAINABILITY. THEY WILL BE ASKED TO WORK WITH CURRENT BUILD SITES AND TO ADOPT APPROACHES THAT APPEAR TO BE SUCCESSFUL AND COLLABORATE WITH BUILD AND RMN AND CEC, AND THE INSTITUTIONAL REQUIREMENTS FOR AN UNDERSERVED INSTITUTION WILL BE THE SAME AS USED IN THE PRIOR AWARDS. THE NATIONAL MENTORING NETWORK, THE NEW PHASE 2 WILL BE AN OPEN COMPETITION. NOW WE ARE SEEKING NEW IDEAS OF MENTORING AND NETWORKING, IDEAS THAT WILL ENHANCE THE EFFICIENCY OF THE ADMINISTRATIVE STRUCTURE AND FOR THAT, WE WILL MOVE FROM A FUNDING MODEL OF THE U54 TO 1 U01 AND 2-U24s. THE EMPHASIS IS AROUND THE SCIENCE OF MENTORING. MENTORSHIP, PROFESSIONAL NETWORKING, ET CETERA AND ACCORD NATION AND OUTREACH CENTER AND THEN A RESOURCE CENTER THAT WILL ORGANIZE THE WHOLE OF THIS. SO I'M GOING TO STOP THERE AND I HOPE THAT I'VE BEEN ABLE TO GIVE YOU AN UPDATE OF WHERE WE ARE. IT'S A LARGE EFFORT THAT ACTUALLY I WOULD SAY NEEDS A LOT MORE RESOURCES TO DO ALL THE THINGS THAT WE NEED TO ACCOMPLISH SO THANK YOU FOR YOUR ATTENTION. >> YES? >> WELL, THANK YOU. MAYBE JUST 2 COMMENTS. ONE IS THAT I'M JUST VERY PLEASED THAT THE NIH HAS CONTINUED ON WITH THIS LINE OF WORK AND IT WASN'T JUST THE TASK FORCE ON DIVERSITY A NUMBER OF YEARS AGO AND RECOMMENDATIONS MADE AND KIND OF DROPPED BUT THAT IS CONTINUING TO--THERE ARE NO SHORTAGE OF IDEAS TO HOW TO GET THINGS MOVING AND THERE CERTAINLY HASN'T BEEN MUCH PROGRESS OVER THE PAST 30 YEARS OR SO, SO CONTINUED ATTENTION IS REALLY IMPORTANT. ONE OF THE THINGS I FIND MUCH MORE OPTIMISTIC NOW THAN PERHAPS AT OTHER TIMES AND I DON'T THINK IT'S BECAUSE I'M JUST MORE FAMILIAR WITH THE TOPIC BECAUSE I'VE BEEN KIND OF IN THIS SPACE FOR A LANGUAGE TIME IS THAT THERE SEEMS TO BE NUMBER OF OTHER ORGANIZATIONS ORGANIZATIONS AND ASSOCIATIONS THAT ARE FOCUSING ON THIS ALSO IN A SLIGHTLY DIFFERENT WAY AND SO THAT PARTNERSHIPS ARE REALLY, REALLY IMPORTANT. FOR EXAMPLE AAMC IS REALLY FOCUSING ON THIS ISSUE WITH RESPECT TO PARTICULARLY AFRICAN AMERICANS IN MEDICINE, BUT SPECIFICALLY BLACK MALES IN MEDICINE JUST HAVEN'T HAD ANY MOVEMENT OVER THE PAST 30 YEARS AND THEN JUST A COUPLE WEEKS AGO, THERE WAS A SESSION AT THE NATIONAL ACADEMY OF MEDICINE THAT DEALT WITH A SIMILAR TOPIC APLU IS LOOKING AT IT FROM THE PROVE ESESSORRIAL STANDPOINT AND DIVERSITY IN THE END POINT SO IT SEEMS TO BE A FAIR NUMBER OF OTHER ORGANIZATIONS THAT ARE IN THIS SPACE AND I'VE BEEN EMPHASIZING THAT PARTNERSHIPS ARE VERY IMPORTANT AND I'M VERY PLEASED TO MENTION THAT HANNAH MENTIONED HER COOPERATION AND COLLABORATION WITH OTHER ICs WITHIN NIH BUT SHE'S ALSO BEEN OUT THERE AND COLLABORATING WITH APLU AND WITH AAMC, AND WITH OTHER ORGANIZATIONS THAT ARE IN THIS CASE, AND LOOKING AT THINGS FROM A SLIGHTLY DIFFERENT PERSPECTIVE SO I WANT TO COMMEND YOU ON THAT HANNAH. >> THANKS. RUSS? >> THANK YOU FOR YOUR CONTINUED OPTIMISM AND ACTIVITY IN THIS AREA. CAN YOU--I WAS STRUCK BY THE IC HIRING DATA VERSUS LASKER AND STADTMAN, DO WE KNOW WHAT'S GOING ON THERE? WHAT ACCOUNTS FOR THOSE DIFFERENCES? >> I TURN IT OVER TO MICHAEL TO COMMENT. >> RUSS WE HAVEN'T DONE A DETAILED ANALYSIS BUT I CAN GIVE YOU SOME FACTORS THAT MIGHT BE IMPORTANT. THE INSTITUTE SPECIFIC HIRES TEND TO BE QUITE SPECIFIC FOR NARROWER RESEARCH AREAS. WE ALSO TALK ABOUT THE LEFT KIDNEY AND THE RIGHT KIDNEY AND THERE BE CANDIDATES COULD BE EMILY EDUCATIONAL AND BY THE FIELD OR BOY OTHER THINGS, WHEREAS THE BROADER SEARCHES WHICH ANNUALLY BRING IN ANYWHERE FROM 400 TO 800 APPLICANTS. WE REALLY ARE LOOKING FOR THE BEST PEOPLE AND IT'S MUCH EASIER TO FIND, MUCH MORE DIVERSE POPULATION IF YOU'RE NOT FOCUSING ON 1 SMALL SPECIFIC RESEARCH AREA. I THINK THAT'S THE MAIN FACTOR. >> THANKS, HANNAH. IT'S A PLEASURE TO SEE HOW QUICKLY YOUR EFFORTS ARE MOVING FORWARD AND I'M REALLY GRATIFIED THAT THE BILL WILL CONTINUE TO DISEMNATION AND TESTING. THE GRAPH IS TROUBLING FOR THE MINORITY GAP TO MOVE FORWARD AND I WONDERED IF YOU ARE AT ALL THINKING ABOUT LOOKING AT THE ROLE OF INSTITUTIONAL PRESTIGE IN THE CAREERS OF DOCTORAL RECIPIENTS. THERE ARE NOW PAPERS EMERGING THAT SAY, THAT YOUR INSTITUTIONAL DEGREE DICTATES HOW FAR YOU WILL MOVE UP. IN OTHER WORDS, INSTITUTIONS DO NOT HIRE FROM INSTITUTIONS OF A LOW PRESTIGE STATUS SO THEN HAVE YOU THE TOP INSTITUTIONS HIRING FROM 1 ANOTHER. BUT IF MINORITY DOCTORAL RECIPIENTS ARE PRIMARILY TRAINED AT THAT OTHER HIERARCHICAL LEVEL, THEY'RE NOT GOING TO BE ABLE TO MOVE UP. SO THE GAP HAS NOTHING TO DO WITH, AS YOU SO ELOQUENTLY SAY WITH TRAINING THE PERSON, YOU CAN TRAIN THEM ALL YOU WANT BUT IF YOU DIDN'T GET YOUR DEGREE FROM THE RIGHT PLACE, YOU'RE NOT GOING TO GET A FOOT IN THE DOOR. SO WITH THE NIH, YOU COULD AT LEAST BEGIN LOOKING AT WHO IS AT NIH, THIS MAY NOT BE POPULAR BUT YOU COULD ASK, WHO APPLIED AND WHERE WERE THEY TRAINED. AND LOOK TO SEE IF THERE IS ANY KIND OF PATTERN THAT EMERGES BECAUSE THE THINKING IN THE FIRST PHASE OF THE COMMITTEES DELIBERATIONS WAS THAT NIH WOULD BE THE MODEL FOR HOW TO DO IT RIGHT. THIS COULD BE INTERESTING. >> SO THANK YOU FOR THAT POINT. I WOULD SAY THAT THE PAPERS ARE CORRECT. THAT THERE IS A STRONG EN--STRATEGIES TUITIONAL BIAS THAT--INSTITUTIONAL BIAS THAT EFFECTS A LOT OF THINGS AND I THINK THE BIG QUESTION IS, HOW DO WE ENGINEER OURSELVES OUT OF IT. PART OF IT IS BY DOING SPECIFIC OUTREACH AND GETTING THESE CANDIDATES IN FRONT OF INSTITUTIONS WHEN EVEN BEFORE THEY NEED TO DO THE HIRING, SO THAT THEY CAN, YOU KNOW MEET FACE-TO-FACE WITH THE PEOPLE AND AS AN EFFORT TO GET OVER THAT INSTITUTIONAL BIAS, WHICH PERVADES INTENSELY AND AS LONG AS WE HAVE THE U.S. NEWS AND WORLD RANKINGS, I WOULD ARGUE WOULD PERSIST, SO WHAT I'VE BEEN WANTING TO EXPLORE IS CAN WE BRING SOME INFLUENCE ON U.S. NEWS AND WORLD REPORT THAT INCLUDES CONSIDERATION OF DIVERSITY IN THEIR FACULTY. DON'T TELL ME ABOUT DIVERSITY IN YOUR STUDENT BODY. SO, I WOULD LIKE TO OPEN THAT UP. BUT I'VE GONE THROUGH THE DEANS, COUNCIL OF DEANS AND HAVE THEME SEED THIS IDEA BECAUSE I THINK IF WE CAN COULD DO THAT IT WOULD INDIRECTLY BEGIN TO ADDRESS YOUR POINT. >> SO I HAVE 2 QUESTIONS, 1 ABOUT INTRAMURAL EFFORTS AND 1 ABOUT PROMOTING CULTURAL CHANGE. SO ON INTRAMURAL EFFORTS, I WASN'T MISSING IT, YOU HAVE 1 ON THE EXPANDING DIVERSITY OF THE NIH CANDIDATE POOLS AND YOU HAD A COUPLE OF PIE GRAPHS WITH THE DISTRIBUTION AND THEN THE COHORT MODEL WHICH YOU WENT OVER SOMEWHAT QUICKLY. I WAS WONDERING IF YOU COULD EXPAND ON THOSE AND THEN I WILL HAVE MY SECOND QUESTION. >> SORRY I WENT QUICKLY, THE COHORT MODEL IS FOR TENURED TRACK. BRINGING IN THOSE PEOPLE THAT ARE STRAIGHT OUT OF THEIR POST DOCS TO BEGENERATED TO BE DEVELOPED IN THE TENURE TRACK HAVE GIVEN THE MENTORING, NEOF NETWORKING, SPONSORSHIP THAT IS ACTUALLY IMPORTANT TO DO THAT, WHICH IS SEPARATE ACTUALLY FROM THE--WHAT WE MIGHT DO FOR THE SENIOR GROUP, BUT STILL VERY MUCH NEEDED. I THINK WHAT YOU WILL FIND IS THAT 1 OF THE ACUTE PROBLEMS FOR DIVERSITY IN THE SENIOR, MEANING TENURED GROUP IS GENDER DIVERSITY DESPITE THE FACT THAT 40% NOW OF TENURED TRACK PEOPLE ARE WOMEN, ONLY 23% ARE TENURED. SO THIS GENDER EQUITY COMMITTEE IS LOOKING INTO THAT AND LOOKING AT HOW WE MIGHT IMPROVE THAT ISSUE AS WELL. WHICH IS NOT JUST IMPROVING THE NUMBERS, BECAUSE THE NUMBERS ACTUALLY DRIVE THE CULTURE. WHEN YOU'RE IN A PLACE AND YOU DON'T SEE OTHERS THAT LOOK LIKE YOURSELF IN LEADERSHIP POSITIONS, IT IS--IT CREATES A NEGATIVE CULTURE, BEHAVIORIAL SCIENCE RESEARCH COMING OUT OF THE WAZOO ON THAT SO WE HAVE CHANGE THAT. >> THE QUESTION ON CHANGING, THE ADDITIONAL CULTURE THROUGHOUT THE COUNTRY, HAVE YOU YOUR FIRST BULLET TRANSPARENCY OF COURSE AND ACCOUNTABILITY IS GREAT, BUT LEADERSHIP COMMITMENT, OFTEN TIMES I FIND THERE IS A LEADERSHIP COMMITMENT BUT THEN, LEADERSHIP DOESN'T GET ENOUGH TRACTION AMONG MAYBE THE LOWER RANKS IN THEIR INSTITUTION SO THEY NEED TO BE EMPOWERED WITH THE BODY OF EVIDENCE THAT SHOWS THAT THIS IS A GOOD THING. SO IS THERE--HOW DO YOU THINK ABOUT FUNDING THE SCIENCE THAT SHOWS THE DIVERSITY AND VARIOUS PERSPECTIVES AND SO ON IS ACTUALLY A GREAT THING FOR THE SCIENTIFIC ENTERPRISE. >> YEAH, WE'VE BEEN WORKING ON DEVELOPING A FUNDING ANNOUNCEMENT THAT WE WILL GATHER MORE EVIDENCE OF THE IMPORTANCE OF DIVERSITY IN HOW IT BENEFITS. BUT THERE'S A PART OF ME THAT REALLY WORRIES THAT, YOU KNOW, NO AMOUNT OF FURTHER EVIDENCE WILL CHANGE BEHAVIOR, YOU KNOW? IT TOOK LIKE--MIKE MIGHT BE ABLE TO CORRECT ME ON THIS, A GAZILLION NUMBER OF TRIALS OF ASPIRIN AFTER A HEART ATTACK TO GET PHYSICIANS TO ACTUALLY PRESCRIBE IT. WE ARE TALKING ABOUT SOMETHING QUITE DIFFERENT ABOUT BEHAVIOR. SO 1 OF THE BEST WAYS THAT HAS BEEN SHOWN TO CHANGE BEHAVIOR IS TO TIE IT TO INSTITUTIONAL REWARDS. AND THAT IS REALLY NOT HAPPENING ANYWHERE AT THE MOMENT. SO IN SECOND WORLD WAR ARE TO YOUR QUESTION, THE BEST WAY TO DO THIS, I SUSPECT IS TO TIE IT TO INSTITUTIONAL REWARD SYSTEMS. >> HANNAH WE TALKED ABOUT THIS SO I UNDERSTAND THE MACRO APPROACHES YOU ARE TAKING WHICH I AM SUPPORTIVE BUT THERE ARE SOME MICRO THINGS THAT SOME INDIVIDUAL CANS DO. WE HAVE TO BREAK THIS INSTITUTIONAL BIAS THING AND SO I'VE BEEN DOING THIS ITTY-BITTY EXPERIMENT IN MY TINY LITTLE INTRAMURAL LAB AND I ONLY ACCEPT POST BACKS FROM PLACES LIKE I TRAINED, STATE UNIVERSITY SOMEWHERE OR CITY COLLEGE SOMEWHERE AND THEN I--THE EXPERIMENT IS, AND THEN WHAT HAPPENS TO THEM? AND YOU KNOW THEY GET INTO THE VERY, VERY GRADUATE PROGRAMS IN THE COUNTRY AULTIMATELY OF YOUR PLACES AND THEY UNBELIEVABLY WELL AND I THINK IT'S BECAUSE THEY'RE REALLY SMART KIDS AND THEY WERE GIVEN THE OPPORTUNITY BECAUSE THEY CAME FROM NIH AND NOT STATE UNIVERSITY SOMEWHERE ANYMORE. YOU KNOW? SO I JUST WONDER IF THOSE AROUND THE TABLE AND FOLKS LIKE THEM WHO COME FROM REALLY AMAZING PLACES JUST GIVE A CHANCE TO SOME OF THESE KIDS AND LET THEM YOU KNOW, BLOSSOM, I THINK YOU COULD HAVE A TREMENDOUS INFLUENCE ON YOUNG PEOPLE'S CAREERS. I MEAN THERE SURE THERE'S LOTS OF OTHER STUFF YOU HAVE TO DO AND OBVIOUSLY YOU'VE MADE A CAREER STUDYING THIS BUT THESE MICRO-EXPERIMENTS FOR ME ARE VERY POWERFUL AND I JUST WISH MORE PEOPLE WOULD--BECAUSE IT'S TOO EASY TO TAKE THE KID FROM HARVARD WHO'S A 4.0, AND THE KID FROM STANFORD WITH A 4 OPINIONED 2, I DON'T KNOW HOW YOU GET A 4.2, I HAVE NO IDEA--[LAUGHTER] --SO YEAH, I DON'T KNOW HOW THAT HAPPENS. BECAUSE IT WORKS? , SO LARRY THAT'S A GREAT POINT IF I MAY TAKE A MINUTE TO RESPOND. IT WORKS. BUT LEFT TO THEIR OWN DEVICES, INDIVIDUAL PIs IT'S NOT GOING TO HAPPEN. IT HASN'T HAPPENED FOR A GAZILLION YEARS BEFORE WHY DON'T WOE HAVE A SYSTEMATIC APPROACH TO MAKE SURE IT HAPPENS. THAT'S MY POINT. >> JUST FOR INFORMATION NSF HAS PROGRAM CALLED RESEARCH PROGRAMS FOR INDIVIDUALS AND THIS IS YOUR CHANCE TO DO A DATING GAME AND BRINS PEOPLE IN FROM INSTITUTIONS YOU WOULDN'T NORMALLY TAKE A CHANCE ON AND IT'S THE SAME EXPERIENCE THAT YOU SAID WE HAVE A LOT OF GREAT SUCCESS STORIES FROM OUR [INDISCERNIBLE]. BUT IT'S FUNDED. YOU HAVE TO ADVERTISE IT FOR CERTAIN PURPOSES AND NSF--[INDISCERNIBLE] >> I THINK YOUR POINT ABOUT--IS ON TARGET WE DON'T NEED MORE EVIDENCE. THE INSTITUTIONAL REWARD IS KEY AND THE GREATEST DRIVER OF INSTITUTIONAL REWARD IN OUR CULTURE IS NIH. I THINK THAT THE FACT THAT YOU KNOW THERE HAVE BEEN A LOT OF EFFORTS, AT THE TRAINING GRANT LEVEL AND SO FORTH IS WONDERFUL BUT THAT DROP OFF, YOU SHOW SO CLEARLY MEANS THAT YOU NEED TO THE SAME INCENTIVE AT THAT NEXT LEVEL OF ASSISTANT PROFESSOR SO MECHANISMS LIKE KAY, MAYBE THERE SHOULD BE AN ENORMOUS BURDENING OF K-AWARD DIVERSITY TARGETS BECAUSE TAKEN--THEY'S WHERE YOU GET INSTITUTIONAL REWARD. >> I THINK LISA WANTED TO ASK A QUESTION. >> I THINK THIS IS MORE OF A COMMENT THAT IS A QUESTION. ALTHOUGH I WANT TO CHIME IN ON THE I AGREE TOO ABOUT THE IMPORTANCE OF INCENTIVES ON AN EN--STRATEGIES TUITIONAL LEVEL. I THINK THAT WE COULD ALSO LAYER THAT WITH INCENTIVES ON INDIVIDUAL LEVELS FOR FACULTY MEMBER WHO IS DO A LOT OF MENTORING OF MINORITY TRAINEES AND JUNIOR FACULTY. I THINK IT'S--IT MAY BE 1 WAY TO CHANGE THE CULTURE IS NOT SO MUCH TO TRY TO CONVINCE PEOPLE WHO WOULD NOT BE INCLINED TO DO THIS ANYWAY BUT BASICALLY TO SUPPORT PEOPLE WHO ARE DOING IT ANYWAY, BUT ARE DOING IT WITH NOTHING. AND SO, I THINK MAYBE LAYERING THE INSTITUTIONAL SUPPORT ALONG WITH SOME INDIVIDUAL INCENTIVES FOR MIDCAREER AND SENIOR LEVEL INVESTIGATES WHO CAN DEMONSTRATE SUCCESS OR TRACK RECORD FOR SUCCESS WITH MENTORING UNDERREPRESENTED CANDIDATES FROM UNDERREPRESENTED GROUPS WOULD BE ANOTHER INCENTIVE. >> SO THIS IDEA IS EMBEDDED INTO THE NEW NIGMS T32. I DON'T KNOW IF YOU WANT TO COMMENT JOHN OR ALLISON. IT'S BEAUTIFULLY INTEGRATED INTO THAT. AND LET ME JUST--WE'RE GETTING TO THE END, ROY MENTIONED PARTNERSHIPS. HERE'S 1 I'VE BEEN THINKING ABOUT IN MY MIND IS WHERE ARE THE STUDENTS OF COLOR ESPECIALLY THE AFRICAN AMERICAN STUDENTS IN UNDERGRAD AND ALL OF THOSE UNIVERSITIES? WHERE ARE THEY? ANYBODY WANT TO GUESS? THEY'RE IN NCAA SPORTS. AND FROM WHAT I'M TOLD, YOU HAVE TO BE PRETTY SMART TO READ THOSE FOOTBALL PLAYS, I DON'T THINK ANYTHING ABOUT IT BUT I THINK WE'RE MISSING A TREMENDOUS POOL THERE. AND I'D LOVE TO BE ABLE TO EXPLORE THAT. THERE ARE THEAN THOUSAND AFFRIC A--BITS AN AMERICAN-- AFRICAN-AMERICAN MEN IN THEIR FINAL YEAR IN THIS, CA SPORTS. --N CA SPORTS. >> SURE JUST A BIT ABOUT THE NEW NIGMS T32. ONE THING WE WANT TO DO WAS TO INSURE THAT DIVERSITY AND INCLUSION WAS EPITHELIAL GRAL TO EXCELLENCE AND TRAINING AND SO IT'S PART OF THE SCORED REVIEW CRITERIA AND IT'S--WE'RE TALKING ABOUT AT THE LEVEL OF TRAINEES BUT ALSO BUILDING A DIVERSE FACULTY TEAM AS WELL AND SO I THINK FOR US, IT'S JUST EXCELLENCE IN TRAINING GOES HAND IN HAND WITH DIVERSITY AND SO THAT WAS AT LEAST 1 OF THE FOCUS OF THE NEW T32. >> SO I ASSUME THAT NIGMS IS THE PIONEER AND THIS KIND OF THING WOULD BE EXPANDED ACROSS OTHER INSTITUTES, I FIND ON OUR TRAINING GRANTS THERE'S A SECTION YOU FILL OUT BUT IT'S NOT REALLY CLEAR HOW ACCOUNTABLE THAT IS WHEN YOU MENTION, IF YOU FILL IN THE SECTION. AND THE SECOND POINT I WOULD MAKE IS THAT A PART OF CHANGING CULTURE AT A FACULTY LEVEL MAY NOT JUST BE HIRING AND PROMOTING PEOPLE FROM UNDERREPRESENTED GROUPS BUT SHOWING EVIDENCE THAT YOU ARE TRYING TO EDUCATE YOUR MAJORITY FACULTY TO MAKE THEM SENSITIVE ABOUT THIS ISSUE, SO I THINK THE PROGRAM IS HAVING SESSIONS ON IMPLICIT BIAS AND APPLICATIONS AND PROGRAM AND FACULTY ARE DOING OUTREACH AND THEY ARE TRAVELING TO PRESENT THE THING, YOU KNOW THAT'S THE KIND OF THING THAT SHOULD BE REWARDED. SO JOSE I WOULD SAY I TOTALLY AGREE WITH YOU ON THAT. YOU HAVE TO HAVE TAKEN--THEY EDUCATIONAL COMPONENT BUT WE NEED MORE. I THINK IF WE STICK WITH THE EDUCATIONAL COMPONENT, WE WILL BE HERE FOR YEARS AND YEARS. THIS THING HAS TO BE LINKED TO WHAT IS REWARDED. >> THANK YOU HANNAH AND THANK YOU ROY. WE'RE NOT DONE YET. WE WILL TALK ABOUT THIS EVERY TIME WE GATHER, THIS IS TOO IMPORTANT--SORRY HANNAH, TOO IMPORTANT TO LET THIS SLIP INTO THE BACKGROUND. I THINK WE HAVE SEEN A WHOLE BUNCH OF INNOVATIVE IDEAS PUT FORWARD AND WE ARE DETERMINED TO CONTINUE AND SUPPORT THE THINGS THAT ARE AND NOT THAT AREN'T. HANNAH'S LEADERSHIP HAS BEEN A WONDERFUL ADDITION TO WHAT HANNAH'S ABLE TO DO WITH MANY COLLEAGUES. SO NEXT TOPIC AND WE'RE RIGHT ON TIME IS TO TALK ABOUT RESEARCH RIGOR AND REPRODUCIBILITY WITH THE ACD WORKING GROUP THAT'S BEEN ADVISING ON THAT, 5 OF WHOM ARE IN THE ROOM SO THIS WILL BE LIVELY CONVERSATION AND MIKE LAUER WILL DO THE PRESENTATION AND KICK IT OFF. SO IT'S ALL YEARS. >> THANK YOU VERY MUCH, FRANCIS SO YOU MAY REMEMBER THAT LAST JUNE WE PRESENTED SOME PRELIMINARY RECOMMENDATIONS THAT WERE GIVEN BY THE ACD WORKING GROUP WHICH RUSS HAS BEEN SHARING AND WHAT WE WOULD LIKE TO DO NOW IS SHOW YOU SOME IDEAS AS A RESULT OF THOSE RECOMMENDATIONS AND WE LOOK TO AN OPEN DISCUSSION AND FEEDBACK ABOUT WHAT YOU THINK AND THIS WILL HELP US AS WE GUIDE THE DELIBERATIONS OVER THE NEXT YEAR OR SO. SO AS A REMINDER, THIS IS THE ACD WORKING GROUP WHICH RUSS IS VERY KINDLY CHAIRED. THERE ARE OTHER PEOPLE IN THE ROOM AND I'M SURE THATIME GOING TO LEAD SOME FOLKS OUT WHO PLAYED A MAJOR ROLE IN DEVELOPING THIS. I SEE SHY SILVER BERG, JUDITH HUGHIT IN ADDITION TO FOLKS LISTED HERE SO AS A REMINDER, THE SECTION 2039 OF THE CURES ACT REQUIRES THE NIH DIRECTOR TO CONVENE A WORKING GROUP UNDER THE ACD TO DEVELOP AN ISSUE RECOMMENDATIONS THROUGH THE ACD FOR A FORMAL POLICY WHICH MAY INCORPORATE OR BE INFORMED BY RELEVANT EXISTING AND ONGOING ACTIVITIES TO ENHANCE RIGOR AND REPRODUCIBILITY OF SCIENTIFIC RESEARCH FUNDED BY THE NIH. SO THE GROUP WAS CONVENED IN FACT, THE DEADLINE FOR THE GROUP TO BE CONVENED WAS TODAY, I THINK, BUT WE WERE WELL AHEAD OF THAT. WE CONVENED THE GROUP LAST SPRING AND PRESENTED REEMILYINARY INFORMATION LAST SPRING. THIS IS A SLIDE THAT WE SHOWED YOU LAST SPRING. THIS IS TO REMIND YOU OF THE NEW CHANGES IN THE APPLICATIONS THAT WERE ESTABLISHED BACK IN JANUARY OF 2016. THERE ARE 4 SPECIFIC ELEMENTS OF RIGOR THAT ARE REQUESTED AND RESEARCH APPLICATIONS INCLUDING PREMISE, RIGOR ITSELF, CONSIDERATION OF RELEVANT BIOLOGICAL VARIABLES INCLUDING SEX AND AUTHENTICATION OF KEY BIOLOGIC AND CHEMICAL RESOURCES AND THE TABLE SHOWS, WE ARE IN THE APPLICATIONS THESE GO, 1 IMPORTANT COMPONENT OR 1 IMPORTANT ISSUE HERE IS THAT THE FIRST 3 PROMISE, RIGOR AND BIOLOGICAL VARIABLES DO CONTRIBUTE TO THE IMPACT SCORE. THE FINE AMILLIO 1 ON--FINAL 1 ON AUTHENTICATION DOES NOT CONTRIBUTE BUT IT'S RATHER EITHER ACCEPTABLE OR UNACCEPTABLE AND IF IT'S UNACCEPTABLE IT REPRESENTS A BAR 2 FUNDING. AS A REMINDER OF THE TIMELINE THAT WE'RE CURRENT LOAMACYY DEALING WITH, THE CURES ACT WAS PASSED A YEAR AGO. THE FIRST MEETING OF THE ACD WORKING GROUP WAS IN THE SPRING. WE GAVE A PRELIMINARY REPORT LAST JUNE. WE ARE NOW GOING TO PRESENT TO YOU SOME THOUGHTS FOR OPTIONS FOR SOME OPEN DISCUSSION AND THEN WE'RE SUPPOSED TO SUBMIT A REPORT TO CONGRESS A YEAR FROM NOW. ALL RIGHT, SO I WILL TALK ABOUT 3 AREAS. ONE IS THE RESEARCH APPLICATION. THE SECTIONAL ANALYSIS IS THE QUESTION OF AUTHENTICATION OF RESOURCES AND THE THIRD IS TRAINING. SO WE'LL FIRST TALK ABOUT THE RESEARCH APPLICATION. ONE IMPORTANT PIECE OF FEEDBACK THAT WE GOT FROM THE ACD WORKING GROUP IS THAT IF THIS IS SOMETHING THAT WE REALLY CARE ABOUT, WE SOMEHOW NEED TO PULL IT. SO FOR EXAMPLE, I THINK I'M QUOTING JOSE HERE, NIH HAS MADE A CLEAR STATEMENT WHEN IT ASKS FOR A SEPARATE SECTION ON AUTHENTICATION, THAT IS A WAY OF SAYING AND YOU KNOW REALLY MEANING THAT THIS IS IMPORTANT TO YOU, MAYBE YOU SHOULD CONSIDER DOING SOMETHING SIMILAR IN THE APPLICATION. PULL OUT SOME SEPARATE SECTIONS THAT WOULD BE CLEARLY LABELED AND WOULD DRAW ATTENTION TO THEMSELVES AND WE TALKED ABOUT A VARIETY OF WAYS WE COULD APPROACH THIS, 1 INSPIRATION IS THE CONSORT CHECK LIST FOR REPORTING OF CLINICAL TRIALS, THERE ARE OTHER TYPES OF GUIDELINES THAT ARE OUT THERE THE ARRIVE GUIDELINES FOR ANIMAL STUDIES AND THERE ARE QUITE A FEW OTHERS THAT ARE LIKE THAT. THE IDEA IS TO SAY THIS IS SOMETHING DHS WHICH IS IMPORTANT SO WE DRAW ATTENTION TO IT. SO NOW WHAT I WOULD LIKE TO DO IS TO WALK YOU THROUGH SOME POSSIBLE IDEAS. WE'RE NOT WEDDED TO ANY OF THEM. THE PURPOSE OF THIS IS TO GET SOME CONVERSATION GOING. SO HERE'S A REMINDER. THIS IS THE PHS398 RESEARCH PLAN. THIS IS WHAT IT LOOKS LIKE AT A VERY HIGH LEVEL. THERE'S THE INTRODUCTION, THERE'S THE RESEARCH PLAN ITSELF, WITHIN THE RESEARCH PLAN THERE'S A SECTION FOR SPECIFIC GAMES, THERE'S RESEARCH STRATEGY AND AS YOU REMEMBER, THE RESEARCH STRATEGY IN MOST CASES IS LIMITED TO 12 PAGES. THEN THERE'S A PROGRESS REPORT FOR ON PUBLICATIONS AND THEN THE NEXT SEGMENT HAS ATTACHMENTS LIKE INVERTEBRATE ANIMALS, MULTIPI PLANS, SELECT AGENTS AND THE SECTION ON AUTHENTICATION AND AT THE BOTTOM WE HAVE THE APPENDIX. SO KEEP POINT IS, WE HAVE A NUMBER OF KEY SECTIONS THAT ARE CLEARLY LABELED AND THE OTHER KEY POINT TO KEEP IN MIND HERE IS THAT, THE PAGE LIMIT OF 12 PAGES APPLIES TO THE RESEARCH STRATEGY. OKAY, SO HERE IS 1 POSSIBLE APPROACH. ONE POSSIBLE APPROACH WOULD BE THAT WITHIN THE RESEARCH PLANNED SECTION WE WOULD HAVE ANOTHER SECTION WHICH WE WOULD CALL, WE COULD CALL IT THE RIGOR SECTION AND THIS WILL BE A DOCUMENT, IT WOULD BE FREE TEXT AND WAWE WOULD ASK PEOPLE TO DO IS WITHIN THIS DOCUMENT, DESCRIBE PREMISE, RIGOR, WHAT ARE THEY DOING TO MAKE THEIR EXPERIMENTS OR SCIENTIFIC DESIGN AS ROBUST AND UNBIS ONED AS POSSIBLE AND INCLUSION OF BIOLOGICAL VARIABLES. SO THIS IS A SEPARATE SECTION, IT'S A SEPARATE DOCUMENT AND IN THIS DOCUMENT WE WOULD ASK PEOPLE TO ADDRESS THESE 3 KEY ELEMENTS. SO LET'S THINK ABOUT THAT. IT DOES DRAW ATTENTION TO ITSELF, IT IS ITS OWN SEGMENT, IT IS LOCATED ALL IN 1 PLACE SO IT MAKE ITS EASY FOR APPLICANTS FOR REVIEWERS AND FOR AGENCY STAFF TO FIND. IT IS COMBINED WITH THE RESEARCH PLAN WHICH KIND OF MAKES SENSE. ANOTHER--ANOTHER KEY POINT IS THAT IT ALLOWS FOR MORE SPACE. THIS THE IS ON TOP OF THE 12 PAGE WHICH IS IS IN THE RESEARCH STRATEGY. JOSE WE'RE TALKIN AND I WERE TALKING ABOUT THIS MORNING ABOUT REFLECTING BACK TO THE DAYS WHEN THE RESEARCH STRATEGY WAS 25 PAGES LONG. SO WHAT'S DISAPPEAR SINCE WE'VE GONE FROM 25 TO 12. NOW HERE WE ADDING A BIT MORE. NOW THIS IS BOTH AN ADVANNEDDAGE AND DISADVANTAGE. IT'S AN ADVANTAGE THAT THERE'S MORE SPACE FOR THEM TO EXPLAIN THE PREMISE AND METHODS, IT'S A DISADVANTAGE THAT CONTENT REVIEWERS ARE GOING TO HAVE TO LOOK AT. SO THIS CAN CONTRIBUTE TO AND OF COURSE THE MATERIAL THAT WOULD APPEAR WITHIN THIS DOCUMENT CAN CONTRIBUTE TO THE OVERALL IMPACT SCORE. WHAT ARE SOME OF THE DISADVANTAGES? ONE OF THOSE DISADVANTAGES THAT THERE MAY BE DUPLICATE ENTRY, YOU MAY HAVE DESCRIBED IN THE RESEARCH STRATEGY, I WILL DO THIS, THIS, AND IN ORDER TO ASSURE THAT MY STUDY IS RIGOROUS AND NOW YOU WILL SAY IT OVER AGAIN IN THE SEPARATE DOCUMENT. ANOTHER IS THAT THIS IS A FREE FORM DOCUMENT. AND IN A WAY THIS MAY BE THE SAME PROBLEM THAT WE'RE FACING RIGHT NOW. BECAUSE IT'S A FREE FORM DOCUMENT, IT MAY--MAKE IT MORE DIFFICULT TO MAKE SURE THAT EVERYTHING THAT YOU WILL WANT TO HAVE IN THERE IS ACTUALLY THERE. AND THAT IT'S EASY TO FIND. AS I MENTIONED, THERE'S MORE CONTENT NOW, FOR REVIEWERS AND ANOTHER DISADVANTAGE, PERHAPS MORE FOR US THAN FOR OTHERS IS THAT THIS WOULD BE A SUBSTANTIVE CHANGE IN THE APPLICATION SO WE WOULD NEED TO RUN THIS BY OMB FOR REVIEW. OKAY, HE WERE'S A SECOND OPTION. SO THE SECOND OPTION IS NOT TO HAVE THE SEPARATE DOCUMENT BUT INSTEAD TO EMBED, YOU MIGHT CALL IT A RIGOROUS SECTION WITHIN THE RESEARCH STRATEGIC PLAN KNOWLEDGEY. SO BASICALLY YOU WOULD SAY WITHIN THE RESEARCH STRATEGY THERE SHOULD BE SECTIONS ENTITLED PREMISE ASK RIGOR, AND BIOLOGICAL VARIABLES. AND THIS IS KIND OF LIKE IN A--MOST JOURNALS WILL SAY THAT WHEN YOU SUBMIT A MANUSCRIPT, IT SHOULD LOOK LIKE THIS. THERE SHOULD BE A SECTION CALLED INTRODUCTION, SECTION CALLED METHODS, THERE SHOULD BE A SECONDS--SECTION CALLED RESULTS AND SOME JOURNALS ARE MORE EXPLICIT ABOUT WHAT THEY ACTUAL LOW WANT TO SEE AND WE COULD DO SOMETHING LIKE THAT. SO IT DOES DRAW ATTENTION TO ITSELF. THERE WOULD BE SECTIONS WITHIN THE RESEARCH STRATEGY THAT WOULD DRAW ATTENTION TO THE FACT THAT THESE ARE ADDRESSING ISSUES OF RIGOR. THEY WOULD BE FOUND IN 1 CLEAR PLACE. IT'S LINKED TO THE RESEARCH PLAN, IT DOESN'T HAVE ANY EFFECT ON PAGE LENGTH. NOW THAT'S BOTH AN ADVANTAGE AND DISADVANTAGE. SO IT'S A DISADVANTAGE IN THAT THERE'S A COLLISION AGAINST THE PAGE LIMITS. THERE'S AN ADVANTAGE IN THAT THE PAGE LIMITS ARE AREN'T ANY LONGER SO THAT MEANS THAT THEY'RE--WE DON'T HAVE MORE PAGES FOR REVIEWERS TO LOOK AT. I GUESS THIS IS ALL A MATTER OF PERSPECTIVE. WE WOULD NOT NEED TO CLEAR THIS FOR OMB. THIS WOULD BE A MATTER OF THE INSTRUCTIONS WE WOULD PUT WITH OUR APPLICATIONS AND OF KOWRGS, WE COULD CONTRIBUTE TO THE SCORE. NOW WHAT ARE SOME OF THE DISADVANTAGES, 2 OF THE DISADVANTAGES ARE THE SAME OF WHAT WE SAW BEFORE IS THAT THERE MAY BE AN ISSUE OF DUPLICATE INFORMATION AND DUPLICATE INFORMATION WOULD BE A REAL PROBLEM WHEN WE'RE ALREADY BUCKING UP AGAINST LIMITS. AND OKAY, THEN HERE'S A THIRD IDEA AND AGAIN I'M ALMOST SURE I WILL BE LEAVING PEOPLE OUT BUT I WANT TO THANK IN PARTICULAR PATRICIA VALDƒZ AND SHYA SILVER BERG AND FOR HELPING PUT TOGETHER THIS PICTURE AND THE IDEA HERE IS THAT YOU WOULD HAVE A SEPARATE FORM, JUST LIKE YOU HAVE A FORM FOR AUTHENTICATION OF RESOURCES, THERE WOULD BE A SEPARATE FORM WHICH WE WOULD CALL THE RIGOR AND TRANSPARENCY FORM, AND THE RIGOR AND TRANSPARENCY FORM WOULD HAVE INDIVIDUAL SEGMENTS AND THERE'S NOTHING SPECIAL OR--THERE'S NOTHING RIGID ABOUT THESE PARTICULAR SEGMENTS THAT ARE LISTED HERE, HEADINGS THAT ARE LISTED HERE, EXCEPT TO SAY THAT WE'RE SHOWING THIS FOR ILLUSTRATION. SO THERE WOULD BE A BOX WHERE YOU COULD EITHER PUT IN TEXT OR PUT IN AN ATTACHMENT DESCRIBING WHAT THE PREMISE FOR THE RESEARCH IS. THERE WOULD BE A BOX WHERE YOU WOULD ENCLUED INFORMATION ABOUT YOUR INCLUSION AND EXCLUSION CRITERIA IF THAT'S APPROPRIATE FOR IS IT THE--STUDY YOU WANT TO DO AND THERE MIGHT BE A BOX FOR DATA MANAGEMENT OR ANALYSIS PLAN OR SAMPLE SIZE DISP WAWHAT EXACTLY THESE ARE THAT'S SOMETHING WE CAN TALK ABOUT BUT THE IDEA IS THAT THERE WOULD BE--IF THESE ARE ITEMS WE THINK ARE REALLY IMPORTANT WE CAN DRAW ATTENTION TO THEM BY--BY PUTTING TOGETHER SOMETHING LIKE THIS HERE. SO FOR EXAMPLE, THERE IS A GREAT DEAL OF CONCERN INTERNATIONALLY THAT ANIMAL STUDIES AND HUMAN STUDIES BUT ANIMAL STUDIES ARE UNDERPOWERED. AND HUMAN STUDIES ARE UNDERPOWERED TOO. SO, IF YOU HAVE A SECTION SAYING ADDRESS YOUR SAMPLE SIZE, THEN THAT'S A WAY OF SENDING A MESSAGE THAT SAYS THIS IS SOMETHING THAT IS IMPORTANT. AND THEN THERE COULD BE ANOTHER SECTION FOR BIOLOGICAL VARIABLES. SO THE IDEA HERE IS THAT WE WOULD DETAILED SEPARATE DOCUMENTS ON PREMARKET AUTHORIZATION EXPIS BIOLOGICAL VARIABLES AND WE COULD MAKE THIS AS GRANULAR OR NOT GRANULAR AS WE WANT. OKAY, SO, IT DRAWS ATTENTION TO ITSELF AND IT'S ALL IN 1 PLACE. PERHAPS 1 ADVANTAGE OF THIS IS THAT THERE IS AN OPPORTUNITY HERE FOR MORE SPECIFICITY TO DRAW ATTENTION TO THOSE ITEMS THAT WE THINK ARE PARTICULARLY IMPORTANT. IT WOULD BE EASIER TO MINE DATA, IF WE INTERESTED IN KNOWING FOR EXAMPLE HOW WELL THESE VARIOUS ELEMENTS ARE BEING ADDRESSED WHICH IS MUCH MORE DIFFICULT TO DO WHEN YOU DEAL WITH TOTALLY UNSTRUCTURED TEXT OR FREE RADICALS TEXT. THIS WOULD NOT COLLIDE WITH PAGE LIMITS AND IT COULD CONTRIBUTE TO THE SCORE. POSSIBLE DISADVANTAGES, THIS IS NOW DISCONNECTED FROM THE RESEARCH PLAN, MAYBE NOT TOO SERIOUS A PROBLEM, BUT IT IS SOMETHING WHICH IS SEPARATE. THERE'S ALSO THE RISK AS BEFORE OF DUPLICATE DATA ENTER, THERE WOULD BE NOW MORE CONTENT FOR REVIEWERS TO LOOK AT. SO AGAIN, THAT'S AN ADVANTAGE OR DISADVANTAGE AND IT'S AN ADVANTAGE IN WHICH YOU HAVE AN OPPORTUNITY TO SPLAIN IN MORE DETAIL WHAT IT IS THAT YOU'RE DOING AND THAT'S AN ADVANTAGE FOR THE APPLICATION, POTENTIALLY DISADVANTAGE FOR THE REVIEWERS IN THAT THEY HAVE MORE MATERIAL TO LOOK AT BUT THENOT OTHER HAND IT'S MORE FOR THEM, BECAUSE IT WOULD BE EASIER TO MAKE JUDGMENTS ABOUT HOW RIGOROUS THE STUDY ACTUALLY IS. I PUT OTHER RIGOR ITEMS QUESTION MARKED. THAT'S JUST TO SAY THAT THOSE PARTICULAR ITEMS ON THE PICTURE ARE FOR ILLUSTRATIVE PURPOSES. THOSE ARE NOT THE 1S. THIS REPRESENTS A SUBSTANTIAL CHANGE IN HOW WE'RE CONSTRUCTING APPLICATIONS SO THIS WOULD REQUIRE OMB CLEARANCE. SO THOSE ARE 3 IDEAS AND WE CAN IN THE DISCUSSION TIME, WE CAN TALK ABOUT THEM AND AGAIN WE'RE NOT LIMITED TO THE OPTION, THE IDEA OF THIS IS TO STIMULATE DISCUSSION. YEAH? IAN? >> THANKS MIKE. MAYBE IERM--I'M NAIVE BUT THE WAY, APPROACH THIS IS I PUT A LOT OF THIS INTO THE 12 PAGE WEES ALREADY HAVE AND WHEN WE--PAGES WE ALREADY HAVE AND WHEN WE TALK ABOUT HUMAN AND INVERTEBRATE STUDIES, JUSTIFY THE SELECTION USING STATISTICAL METHOD AND SHOW THAT WE WILL HAVE A STUDY. SO, I'M JUST WONDERING WHETHER OR NOT OTHER PEOPLE HAVE THAT APPROACH RIGHT NOW OR WHETHER THEY BREAK OUT OF A SEPARATE SECTION OF RIGOR, EXISTING APPLICATIONS? >> WHAT IS ROSS DOING? >> WELL IT RAISES THE ISSUE THAT MOST OF THIS DISCUSSION IS ABOUT HOW DOJ REALLY GOOD SCIENCE SO IF ALL THE PROPOSALS WERE WRITTEN AS REALLY GOOD SCIENCE THAT WOULD NOT BE AN ISSUE. BUT IT HAS BECOME CLEAR THAT WE GET TRICKED AND SO WE GET TRICK INDEED A NUMBER OF DIFFERENT WAYS SOPHISTICATEDY WE ARE TRYING TO FIGURE OUT WAYS FOR REVIEWERS TO THINK ABOUT THESE ISSUES AND DO THIS EXTRA CHECK ON THE QUALITY OF THE SCIENCE. SO IT COMES UP NOVEMBER-YOU ASK ME WHAT I DID, IT DOESN'T COME UP SO MUCH, I DO INFORMATICS AND IN INFORMATICS DATA SHARE SUGGEST A HUGE THING AND I ALWAYS PUT IN DATA SHARING BECAUSE I KNOW IT WOULD BE A POSITIVE IF I HAD A GOOD DATA SHARING PLAN. THEN WE ADD THAT SECTION, IN FACT I WAS INVOLVED INVOLVED IN ADDING THAT AND MY NORMAL COURSE OF MOO I GRANT BECAUSE I'M PROUD OF IT AND IT'S AN INTEGRAL PART OF WHAT I'M DOING AND I HAVE TO SAY, AS DISCUSS INDEED SECTION 2.3.4, WE'RE GOING TO DO A LOT OF DATA SHARING SO IN THE BEST CASE, PEOPLE LIKE YOU WILL HAVE DONE ALL THIS AND YOU WILL HAVE VERY SHORT ANSWERS TO WHATEVER WE DO, WHERE YOU WILL SAY, THIS IS AN EXCELLENT ISSUE AND THEN IN 2.3.4, I PERFECTLY WELL ADDRESSED IT AND YOU CAN GO READ IT AGAIN IF YOU WANT. BUT IT'S TRICKY. >> SO I THINK A GOOD EXAMPLE OF THAT THE REASON WHY THE CONSORT CHECK LIST WAS PUT TOGETHER FOR CLINICAL TRIALS WAS BECAUSE WHEN PEOPLE LOOKED THEY SAW THAT MOST CLINICAL TRIAL REPORTS WERE MISSING WHAT YOU MIGHT THINK OF AS BEING FUNDAMENTAL ELEMENTS. THEY WEREN'T THERE. AND SO A GROUP OF PEOPLE GOT TOGETHER INTERNATIONALLY AND SAID, OKAY, WHAT DO WE NEED TO SEE IN A CLINICAL TRIAL REPORT AND MOST OF THE JOURNALS NOW HAVE ACCEPTED THAT. I REMEMBER WHEN I WAS AN EDITOR IN JAMA, THIS WAS HELPFUL. WE WOULD GET THE LIST AND SEE THE KEY ELEMENTS WERE THERE AND IF THEY WEREN'T THERE WE WOULD GO BACK TO THE AUTHORS AND SAY WE CAN'T HANDLE THIS PAPER UNTIL YOU TELL US WHAT DID YOU DO HERE? AND SO THAT--THERE'S BEEN SUBSEQUENT WORK THAT'S BEEN DONE THAT HAS SHOWN THAT THE OVERALL QUALITY OF CLINICAL TRIAL REPORTING AS INCREASED SINCE THAT CHECK LIGHT HAS BEEN PUT IN. ANOTHER POINT AND I THINK THIS GETS TO ACTUALLY ECHO WHAT IS HANNAH SAID IN THE LAST TALK, THERE'S AN OLD LINE, I THINK IT COMES FROM LOUIS GERSHNER WHO IS THE CEO OF IBM, IT'S WHAT WHAT YOU INSPECT, - IT IS WHAT YOU EXPECT, SO IF IF EXPECT THESE IN YOUR GRANT APPLICATIONS AND GRANT REPORTS THEY WILL SHOW UP BECAUSE THEY KNOW YOU WERE INSPECTING THEM. >> LISA? >> WHAT I'M CONCERNED ABOUT IS THAT IT DOESN'T LOOK LIKE IT'S A CHECK LIST, IT LOOKS LIKE IT'S HAVING TO DUPLICATE INFORMATION LIKE FROM MY PERSPECTIVE. SO IF IT CAN BE CHANGED SO IT APPEARED AND WORKED MORE LIKE A CHECK LIST, I THINK POINTING PEOPLE TO WHERE TO FIND THE INFORMATION AS OPPOSE TO HAVING TO RECREATE IT IN SOME WAYS, I THINK IT WOULD MAKE IT LESS BURDENSOME ON PEOPLE WHO ARE ACTUALLY DOING THE PROPOSAL AND THEN ALSO OF COURSE, HIGHLIGHT IT FOR PEOPLE WHO HADN'T BEEN THINKING ABOUT THOSE ISSUES. SO I THINK IF WE CAN TRY TO MAKE IT THAT WAY AS MUCH AS POSSIBLE IT WOULD BE MUCH MORE USER FRIENDLY AND LESS BURDENSOME BECAUSE THERE'S SO MUCH THAT WE ALREADY ARE EXPECTED TO TO DOCUMENT. AND THEN THE OTHER COMMENT I HAVE AND I THINK I'VE SAID THIS ON OUR PHONE CALLS BEFORE, BUT THIS WHOLE QUESTION ABOUT THE BIOLOGICAL VARIABLES, AND FORGIVE ME IF I RAISED THIS BEFORE AND IT'S BEEN ADDRESSED BEFORE BUT WHY IS IT THAT IT'S ONLY FOCUSED ON THAT? BECAUSE I'M THINKING ABOUT THE KIND OF RESEARCH I DO AND I'M NOT SAYING THAT I WOULDN'T COLLECT BIOLOGICAL VARIABLES BUT THERE MIGHT BE OTHER VARIABLES THAT ARE MUCH MORE RELEVANT TO THE KIND OF RESEARCH THAT I'M DOING SO I THINK IF WE WANT TO BE--MAKE THIS SOMETHING THAT'S APPLICABLE TO THE WHOLE RANGE OF RESEARCH BEING DONE THAT IT PROBABLY SHOULDN'T BE LIMITED TO JUST BIOLOGICAL. >> YEAH, MAKES A LOT OF SENSE. >> THIS IS RICK--I'D LIKE TO CHIME IN ON THAT. I THINK THE LIST HAS SHOWN ON THE SLIDE IS APPLICABLE TO CERTAIN TYPES OF RESEARCH AND NOT OTHERS. I'M WONDERING IF--HOW MY STRUCTURAL BIOLOGY COLLEAGUES WOULD TAKE TO INCLUSION/EXCLUSION,/BLINDING, SAMPLE SIZE, YOU KNOW I SUSPECT THAT IT MIGHT BE BETTER TO SIMPLY ASK FOR A SECTION WHERE YOU ASK SOMETHING ALONG THE LINES OF WHAT STEPS WILL YOU TAKE TO INSURE THAT YOUR RESULTS ARE ROBUST AND REPRODUCIBLE AND AVAILABLE? I THINK MOST GOOD INVESTIGATORS PUT THIS IN AND I SUSPECT THERE WILL SOME THAT WILL ADD TO THEIR GRANTS AND WILL GIVE SOME OPPORTUNITY TO EVALUATE THAT MORE DIRECTLY PERHAPS BUT I'M SKEPTICAL OF TRYING TO PRESCRIBE A CERTAIN SET OF QUESTIONS THAT WILL BE BROADLY AFFRICCABLE TO ALL NIH APPLICATIONS. >> YES? >> I REMEMBER WHEN GRANTS WERE 25 PAGES WE HAVE EXPERIMENTAL DESIGN AND ALL THIS WAS IN THERE AND WHEN WE HALVED THE GRANT ITS WENT AWAY. IS IT ALL BEING ADDED BACK SO THE LENGTH WILL START TO CREEP UP? IN OTHER WORDS THIS WAS THERE, THIS IS RIGOR, THAT'S EXPERIMENTAL DESIGN. >> YEAH JOSE? >> SO WE TALKED ABOUT THIS MORNING, I WAS TRANSLATING THAT COMMENT THAT WE EACH MADE ON THE BUS TO ME. SAME CONVERSATION. BUT I THINK THE SECOND OPTION WHERE YOU MAKE IT PART OF THE RESEARCH STRATEGY BUT WITH REQUESTED HEADINGS, AND DOESN'T NECESSARILY HAVE TO LEAD TO DUPLICATION BECAUSE YOU CAN SAY FOR DETAILS ON THE METHODS PLEASE PREFER TO THE SECTION ON RIGOR, YOU KNOW 2 PAGES BACK, SO, I THINK YOU CAN--YOU CAN BE PART OF BEING WHERE IT BELONGS WHICH IS PART OF THE RESEARCH PLAN, AND NOT ADD TO THE MINDS OF MATERIAL THAT PEOPLE HAVE TO READ AND NOT ADD DUPLICATION TO THE WRITER. >> OTHER THOUGHTS ON THIS BEFORE WE MOVE ON TO THE NEXT SECTION. WE CAN COME BACK TO THIS. YEAH? JEFF? >> FIRST OF ALL I AGREE IT SHOULD BE INCORPORATED INTO THE RESEARCH PLAN LIKE JOSE AND OTHERS JUCH SAID, I'M WONDERING, WHERE IS DATA PROVIDENCE IN THIS WHOLE DISCUSSION? I HEARD ABOUT BIOLOGICAL AND CHEMICAL AUTHENTICATION BUT WE NEVER TALK ABOUT DATA AUTHENTICATION, SO CAN YOU ELABORATE ON HOW DO WE ACHIEVE DATA PROVIDENCE AS PART OF THIS. >> I'M SORRY CAN YOU GO ON? >> SOURCES OF DATA, WHAT ARE THE SYSTEMS IN PLACE AT YOUR OWN EN--STRATEGIES TUITION THAT MAKE IT CLEAR--INSTITUTION THAT MAKE IT CLEAR THAT DATA CANNOT BE CORRUPTED AND THERE THERE IS A SYSTEM, CHAIN OF CUSTODY OF THE DATA THAT YOU'RE USING TO CARRY OUT YOUR RESEARCH OR FINISHURE RESEARCH FOR OTHERS TO BE ABLE TO REPRODUCE YOUR RESEARCH? >> I THINK THAT'S VERY INTERESTING. THAT'S PROBABLY SOMETHING WHICH WOULD TRAN SEND MOST--TRANSCEND MOST FIELDS OF RESEARCH, IF NOT ALL, THAT WE INCLUDE. SO, WITH ANY OF THESE OPTIONS, WE COULD FIGURE OUT A WAY OF INCORPORATE THAGOREAN AND WE COULD ASK FOR IMPLICIT INSTRUCTION OF THESE, WE COULD HAVE A SECTION ON IT, THERE ARE A WHOLE VARIETY OF WAYS WE CAN POTENTIALLY APPROACH THAT. >> MICHAEL. SO I THINK IT'S AN IMPORTANT PROBLEM, WITH REPRODUCIBILITY. I'M A LITTLE RELUCTANT TO PUT TOO MUCH MORE REQUIREMENTS IN BUT MY QUESTION IS, WILL IT MAKE ANY DIFFERENCE? MAKE A DIFFERENCE TO THE GRANT THAT YOU WRITE? IS IT GOING TO MAKE ANY REAL DIFFERENCE? AND HOW WILL YOU KNOW? >> OKAY, SO THAT'S A GREAT QUESTION AND ACTUALLY THERE'S A LOT OF THOUGHT GOING INTO THAT AND WE ARE HAVING DISCUSSIONS WITH OUTSIDE FUNDING ORGANIZATIONS AND ALSO WITH THE NATIONAL ACADEMIES ABOUT WAYS WE CAN LOOK INTO THIS. SO 1 APPROACH IS YOU CAN EVALUATE THE GRANT APPLICATIONS THEMSELVES AND SEE IF THERE ARE MATERIALS WITHIN THE APPLICATIONS AND WITHIN THE REVIEWS THAT YOU WEREN'T THERE BEFORE AND THAT'S SOMETHING THAT SOME OF US ARE DOING AND WE ARE ALSO PURSUING AN IDEA OF LOOKING AT GRANT APPLICATIONS AND THEN PUBLICATIONS THAT GO ALONG WITH THOSE GRANT APPLICATIONS AND TRYING TO SEE WHETHER OR NOT THERE ARE CHANGES OVER TIME. THERE ARE PEOPLE WHO HAVE DONE WORK LOOKING TO SEE WHETHER OR NOT THERE ARE PUBLICATIONS WITHIN CERTAIN FIELDS ARE DOING A BETTER JOB OF REPORTING OUT CERTAIN ELEMENTS SUCH AS SAMPLE& SIZE OR RANDOMIZATION AND MASKING, SOME FIELDS SEEM TO BE SEEING REAL IMPROVEMENT, NEUROSCIENCE FOR EXAMPLES WHERE THERE ARE STARTING TO SEE REAL IMPROVEMENT BUT WE'RE ENGAGING IN SOME DISCUSSIONS WITH A VARIETY OF OTHER PEOPLE INCLUDING JOURNAL EDITORS AND OTHER FOUNDATIONS AND FUNDERS, TO THINK ABOUT WAYS OF DOING EXACTLY THAT. THAT'S RIGHT. THAT IS THE QUESTION. BECAUSE WAWE'RE AFTER HERE IS BETTER SCIENCE. OKAY THE NEXT TOP BEING I WILL TALK ABOUT QUICK AND BRIEFLY, THERE WAS DISCUSSION ABOUT AUTHENTICATION OF RECOURSES AND IN OUR DISCUSSION THERE WAS A QUESTION ABOUT WHETHER OR NOT WE COULD SET UP A GOOD HOUSEKEEPING SEAL OF APPROVAL, SOME KIND OF A SYSTEM. WE'VE LEARNED A LITTLE BIT ABOUT THIS, ABOUT WHAT'S HAPPENING OUT IN THE WORLD. THERE IS A--THERE IS I MARKET OUT THERE FOR RESOURCE VALIDATION, THIS IS NOT AN ENDORSEMENT, THIS IS SIMPLY SOME PICTURES TO SHOW YOU VARIOUS THINGS THAT ARE OUT THERE. THERE'S AN ANTIBODY VALIDATION DATABASE, THERE'S--THIS IS GBSI, ALSO INTERESTED IN ANTIBODIES, THERE'S A SITE HERE CALLED BIOSI, THEY WILL SOLVE THE REPRODUCIBILITY CRISIS AND THIS 1 CALLED BIOZ, AND THIS 1 ACTUALLY YOU TYPE IN WHAT YOU'RE INTERESTED IN. YOU CAN TYPE IN, I TYPE INDEED CELL LINE AND YOU CAN BE AS SPECIFIC AS YOU WANT AND THEY'LL GIVE YOU RATINGS. THIS IS LIKE CONSUMER REPORTS. I DON'T KNOW HOW MANY OF YOU DO THIS BUT EVERY YEAR I FILL OUT A REPORT AND EVERY YEAR I WILL SAY I LOVE MY CAR AND I WILL BUY ANOTHER 1. SO THAT'S THE WAY YOU KNOW WHETHER OR IN NOT THEY SERVE 10S OF THOUSANDS OF PEOPLE AND THAT INFORMATION IS USEFUL. MAYBE AMAZON MIGHT BE ANOTHER EXAMPLE. BUT THE POINT IS THAT THERE IS A LOT GOING ON OUT THERE, I'M SURE THIS IS--I'M JUST TOUCHING THE TIP OF THE ICEBERG, IT'S INTERESTING THIS MORNING I WENT BACK AND LOOKED AT THE IF, AQTHAT IS WE PUT UP A WHILE AGO ON AUTHENTICATION OF RESOURCES AND NOTICED THAT THERE WAS A QUESTION ABOUT WHETHER OR NOT NIH WAS GOING TO SAY THIS 1 IS OKAY AND THIS 1 IS NOT AND THE ANSWER THAT WE GAVE WAS THAT WE ENCOURAGED THE SCIENTIFIC COMMUNITY OR PERHAPSA I BETTER WAY OF SAYING IT, THE SCIENTIFIC COMMUNITIES TO WORK ON THIS AND IT APPEARS THAT THERE ARE EFFORTS THAT ARE ONGOING. OKAY. THEN THE FINAL ITEM I WANT TO TALK ABOUT HAS TO DO WITH TRAINING AND WE'VE HEARD A LITTLE BIT ABOUT THIS, ABOUT THE T32 THAT NIGMS HAS PUT OUT BECAUSE THAT'S VERY RELEVANT TO THIS. SO WHEN WE TALK ABOUT TRAINING, LAST SPRING, WE TALKED ABOUT WAYS IN WHICH THE--THE--QUESTIONS OF RESPONSIBLE CONDUCT OF RESEARCH AND RESEARCH INTEGRITY CAN BE MELDED INTO RIGOROUS CONDUCT OF RESEARCH. IN A WAY THAT THERE IS A SPECTRUM, AND THESE ARE NOT 2 ENTIRELY DISTINCT AREAS AREAS AND WE MENTIONED THAT SHORTLY BEFORE WE GOT TOGETHER THE NIH,--THE NAS HAD PUT OUT A REPORT CALLED FOSTERING INTEGRITY AND RESEARCH, THEY TALKED ABOUT NOT ONLY GROSS I I VIOLATIONS LIKE PLAGIARISM AND FABRICATION BUT ALSO DETRIMENTAL RESEARCH PRACTICES SO THAT MIGHT BE P-HACKING OR DATA EMBELLISHMENT LEAVE BEING OUT OUTLIERS THAT ARE INCONVENIENT, THINGS LIKE THAT. SO THE NARCOTICS IGMS, JOHN AND ALLISON IS HERE, SO THE NIGMS PUT OUT THIS INTERESTING T32 FOR PREDOCTORAL CANDIDATES. THIS WAS JUST PUBLISHED A COUPLE OF MONTHS AGO, AND APPLICATIONS WILL BE COMING IN IN THE SPRING AND THIS IS WORTH READING AND THERE'S A LOT IN HERE, I'VE SELECTED OUT SOME TEXT WHICH IS ALMOST CERTAINLY NOT ALL OF IT, BUT IN THERE, IT POINTS OUT THAT THEY'RE LOOKING FOR A STRONG FOUNDATION IN SCIENTIFIC REASONING, RIGOROUS RCH DESIGN, EXPERIMENTAL METHODS, QUANTITATIVE APPROACHES AND DATA ANALYSIS AND INTERPRETATION BUT THE--THE EN--STRATEGIESITUTE IS ALSO LOOKING FOR COMMITMENT TO APPROACHING AND CONDUCTING BIOMEDICAL RESEARCH RESPONSIBLY AND WITH INTEGRITY. AND I'LL JUST READ 1 SECTION HERE WHICH I THINK ILLUSTRATES HOW THESE ARE BEING PUT TOGETHER. THIS IS ON A SECTION HERE CALLED PLAN FOR INSTRUCTION AND THE RESPONSIBLE CONDUCT OF RESEARCH. I'M JUST READING STRAIGHT FROM THE F. O. A. DESCRIBE HOW THE RESPONSIBILITY CONDUCT OF RESEARCH COMPONENTS ARE SUFFICIENTLY WELL INTEGRATED INTO THE OVERALL CURRICULUM. THAT IS HOW THEY ARE TAUGHT AT MULTIPLE STAGES OF TRAINING DEVELOPMENT AND IN A VARIETY OF FORMATS AND CONTEXT. EXPLAIN HOW THE TEACHING OF RESPONSIBILITY OF RESPONSIBLE CONDUCTIVE RESEARCH SYNERGIZES WITH ELEMENTS OF THE CRICK WILL YOU PLEASE DESIGNED TO ENHANCE TRAINEES ABILITIES TO CONDUCT RIGOROUS AND REPRODUCIBLE RESEARCH. DESCRIBE HOW ALL PROGRAM FACULTY WILL REITERATE AND AUGMENT KEY ELEMENTS OF RESPONSIBLE CONDUCT WHEN TRAINEES ARE PERFORMING RESEARCH IN THEIR LABORATORIES. SO I'VE PICKED OUT SOME OTHER TEXT FROM HERE, BUT--BUT I THINK THAT 1 OF THE KEY POINTS HERE IS THAT IS A NICE ILITRATION, WE WILL SEE HOW THIS WORKS OUT BUT THIS IS A NICE ILITRATION OF THE AGENCY, EXPLICITLY ARTICULATE THANKSGIVING IDEA AS PART OF TRAINING INTEGRATING RESPONSIBLE CONDUCTIVE RESEARCH AND INTEGRATING TRAINING AND RIGOROUS CONDUCTIVE RESEARCH SHOULD BE INTEGRATED AND MELDED TOGETHER. SO, JUST TO SUMMARIZE WHAT WE'VE TALKED ABOUT, AND WHAT QUEE CAN CONTINUE TO TALK--WE CAN CONTINUE TO TALK ABOUT REGARDING THE RESEARCH APPLICATION ITSELF, THE QUESTION IS, HOW GRANULAR SHOULD WE MAKE IT, SHOULD WE HAVE SEPARATE OR INCLUDED SECTIONS? HOW DO WE AVOID DUPLICATE INFORMATION? WE'VE ALREADY TOUCHED ON SOME OF THESE IN DISKUTIONZ WE'VE HAD TO DATE. REGARDING VALIDATION OF RESOURCES TO HELP WITH VALIDATION OR AUTHENTICATION OF BIOLOGICAL RESOURCES, THERE ARE RESOURCES THAT ARE OUT THERE, MY GUESS IS THAT THIS IS A GROWING MARKET AND THEN REGARDING RESEARCH TRAINING, QUESTION IS HOW BEST TO INTEGRATE TRAINING OF RIGOR WITH RESPONSIBLE CONDUCT OF TRAINING OF RESPONSIBLE CONDUCTIVE RESEARCH AND WE'RE SEEING NOW, IN THE NIGMS T32, AN INTERESTING EXAMPLE OF HOW THIS MAY MOVE FORWARD. I'LL BE HAPPY TO ADDRESS ANY OTHER THOUGHTS OR COMMENTS ON THIS. >> I VERY MUCH LIKE THE IDEA OF COMBINING RIGOR WITH THE RESPONSIBLE CONDUCT TO INSURE SOME MINIMAL EXPOSURE TO THE IDEA. >> [INDISCERNIBLE]. >> MARY SUE? >> THIS MAY BE A NAIVE WEB QUESTION BUT WHAT DOES IT MEAN TO GO THROUGH OMB REVIEW. >> [LAUGHTER] >> SO IT'S NOT NAIVE AT ALL. SO, THERE'S SOMETHING CALLED THE PAPERWORK REDUCTION ACT WHICH OF US THINK IS PARADOXICALLY NAMED, IF YOU KNOW WHAT THAT IS, BUT ESSENTIALLY IF WE ARE MAKING--ACTUALLY, YOU KNOW THIS GETS TO LISA'S POINT. IF WE'RE GOING TO INCREASE BURDEN ON PEOPLE IN THE PUBLIC THROUGH AN ACTION THAT WE'RE TAKING HERE IN THE FEDERAL GOVERNMENT, THAT'S SOMETHING THAT THE OMB NEEDS TO REVIEW TO MAKE SURE THAT IT'S PROPERLY JUSTIFIED. FOW WE'VE GOT AN IMPORTANT EXCEPTION TO THAT, VERY IMPORTANT EXCEPTION TO THAT IN THE 21st CENTURY CURES ACT WHICH IS THAT THE PAPERWORK REDUCTION ACT NO LONGER APPLIES TO RESEARCH WHICH IS CONDUCTED BY THE NIH BUT THIS ISN'T RESEARCH, THESE ARE APPLICATIONS THAT WE'RE ASKING PEOPLE TO FILL OUT. SO THAT'S WHY WE'RE MAKING MAJOR CHANGES IN THESE APPLICATIONS WE WOULD NEED TO GET OMB REVIEW. >> THAT TRANSLATES INTO 9 OR 10 MONTHS? , YEAH. >> AT LEAST. >> OTHER THOUGHTS OR COMMENTS. ONE THEME I AM HEARING IS THAT THERE SEEMS TO BE MORE ENTHUSIASM FOR SOME WAY OF LABELING OR POINTING TO WHERE THE KEY ELEMENTS ON PREMISE, RIGOR, INCLUSION TO VARIABLES ARE BUT NOT HAVING DUPLICATE SECTIONS, THAT'S 1 MESSAGE I HEARD, SECONDS MESSAGE I HEARD IS THAT WE HAVE TO--THERE ARE OTHER ELEMENTS THAT NEED TO BE INCLUDED SUCH AS DATA PROVIDENCE, ALL RELEVANT VARIABLES NOT JUST BIOLOGICAL VARIABLES. AND I'M INSURING GENERAL ENTHUSIASM FOR THE DIRECTION THAT THE NIGNS T32 IS GOING TO, RUSS? NO? MARY SUE? >> SO YOU BROUGHT UP THIS POINT ABOUT THE MARKET, YOU KNOW WE TALKED ABOUT THAT, ABOUT THE MARKET THAT'S BEING DEVELOPED FOR VALIDATION, IS THIS SOMETHING THAT NIH WILL HAVE TO VET? OR IF I MEAN JUST BECAUSE A MARKET IS DEVELOPING DOESN'T MEAN THIS IS VALID. SO I JUST THINK IT'S A SNAKE'S NEST. I DON'T KNOW HOW TO-- >> LARRY? >> IT'S A CONUNDERLYING CONUNDRUM, RIGHT? PEOPLE WHO USE ANTIBODIES KNOW IT'S AT BEST A CRAP SHOOT, RIGHT? SO WHY--WHY ARE WE NOW ALL WORRIED ABOUT THIS? WELL, YOU KNOW A HUNDRED YEARS AGO IN THE GOOD OLD DAYS WE ALL MADE OUR OWN ANIMALS SO WE DIDN'T HAVE THIS PROBLEM, BUT NOBODY DOES THAT ANYMORE. OKAY? SO THERE'S GOT TO BE SOME APPROACH BECAUSE WE'RE--WE ARE WASTING SIGNIFICANT SUMS OF MONOREAGENTS THAT SIMPLY DON'T WORK. SO HOPEFULLY THE MARKET WILL BE PART OF THE SOLUTION HERE. SOME ENTREPRENEURIAL TYPE PEOPLE WILL DEVELOP A SCHEME TO VALIDATE THINGS, PEOPLE WILL LOOK AT THE CONSUMER REPORT OR THE EQUIVALENT, YELP,. >> YELP,. >> THANK YOU, AND FOLKS WILL SAY THIS ANTIBODY SHOULD BE GOOD, YOU TRY IT AND IT'S GOOD AND YOU GO WOW, LET ME GO BACK TO THEM THE NEXT TIME I NEED AN ANTIBODY OR YOU WILL USE IT AND WON'T WORK AND YOU SAY OH GHEE, THESE PEOPLE DON'T KNOW WHAT THEY'RE TALKING ABOUT AND YOU GET RID OF THEM. BUT I DON'T THINK NIH CAN BE IN THE BUSINESS OF AUTHENTICATING THESE TYPES OF-- >> LINDA. >> SO 1 OTHER TECHNOLOGY TRANSFER WE TALKED ABOUT MARY SUE IS HAVING REALLY GOOD EXAMPLES TO SHOW HOW TO WRITE THESE PARTS FOR DIFFERENT KINDS OF RESEARCH BECAUSE THERE ARE A NUMBER OF EXAMPLES ON DIFFERENT INSTITUTE WEBSITES OF HOW TO WRITE THIS CERTAIN PART OF A GRANT AND THEY'RE SUPER, SUPER HELPFUL SO WE VIEWED THIS AS AN EDUCATIONAL TOOL THAT SOMEONE COULD WRITE, NIH DOESN'T HAVE TO ENDORSE ANYTHING BUT SOMEONE COULD WRITE A HIGHLY VETTED EXAMPLE AND THEN THAT WOULD EDUCATE THE COMMUNITY AND HERE'S THE STANDARD TO WHICH YOU WILL BE JUDGED BECAUSE A TEMPLATE IS WORTH 1 TRILLION WORDS. >> YOU KNOW WHEN THINKING ABOUT THIS, REALLY YOU BREAK IT DOWN INTO 3 COMPONENTS, RIGHT? ONE IS TRAINING AND 1 IS WHAT YOU'VE BEEN FOCUSED ON WHICH IS WRITING THE PROPOSAL AND THE THIRD WHICH IS IMPORTANT IS THE STANDARD THAT WE ALL LIVE BY WHICH IS PEER REVIEW AND PERHAPS THERE'S EVEN ENOUGH THOUGHT PUT INTO GUIDANCE FOR PEER REVIEW AS OPPOSE TO PREPARING THE PROPOSAL. BECAUSE I WORRY AT THE END OF THE DAY, IT BECOMES A GRANDSMANSHIP ISSUE. YOU LEARN HOW TO WRITE ALL THESE THINGS ABOUT YOU IT DOES IT REALLY CHANGE PRACTICE? AND THE BOTTOM LINE IS, YOU KNOW ONCE THE GRANT IS FUNDED IT MAY OR MAY NOT BUT WHERE THE CHECKS AND BALANCES OCCURS AS YOU POINTED OUT IS THE QUALITY OF THE PUBLICATION, IS THERE DOWN STREAM WORK, WHAT IS THE FIELD OF OR FIELDS, SO ANOTHER COMPLIMENTARY APPROACH IS TO GIVE MORE ROBUST GUIDANCEOT PEER REVIEW SIDE AND I THINK WE ALL AS SCIENTISTS WHEN WE SIT AROUND THE TABLE AND LOOK AT SOMETHING AND IT MAY BE A HIGH PROFILE PUBLICATION OR NOT AND IT'S THE ONLY PUBLICATION OF ITS KIND AND NEVER TALKED ABOUT AGAIN, THERE ARE ALL ISSUES WITH RIGOR AND REPRODUCIBILITY SO PERHAPS TO ADDRESS THAT MORE HEAD AND CENTER, AT THE REVIEW STAGE, JUST LIKE MANY JOURNALS ARE DOING MAYBE MORE IMPACTFUL ACTUALLY BECAUSE I JUST WORRY THAT YOU ADD FORMS, WE GO BACK AND FORTH BETWEEN 12 AND 25 PAGES AND IT DOESN'T CHANGE PRACTICE AND AS MIKE POINTED OUT, AT THE END WE WON'T KNOW WHETHER WE HAD AN IMPACT. I THINK THERE'S NO DOUBT AT THE LEVEL OF TRAINING BECAUSE WE CAN ENFORCE THAT THERE WILL BE--Y KNOW IT'S DONE. CERTAINLY THE OTHER END OF THE SPECTRUM IS INFORMING PEER REVIEW AND GIVING MORE GUIDANCE THERE PERHAPS IN THIS AREA. >> YEAH, I THINK IT MAKES A LOT OF SENSE. SMRKS SO WE HAVEN'T TALKED ABOUT IT BUT I THINK IT'S RELATED THAT NOW PUBLICATION HAS OPENED UP AND WE'RE PUBLISHING NEGATIVE RESULTS AND I THINK THAT IS GOING TO BE HELPFUL HERE BECAUSE I THINK THERE WERE A LOT OF PRESSURE TO PUBLISH THE EXCEPTIONAL RESULT WHICH MAY HAVE BEEN RESOURCE RELATED. IT WAS EXCEPTIONAL RESULT BECAUSE THE ANTIBODY WAS BEING MADE IN A DIFFERENT WAY NOT BECAUSE YOU WERE LOOKING AT SOMETHING PHENOMENAL. SO I THINK SOMEHOW I THINK THAT IS ALSO GOING TO HELP MOVING FORWARD WITH THE RIGOR AND REPRODUCIBILITY. >> RUSS? >> I JUST WANT TO THANK MIKE AND HIS TEAM FOR LEAD THANKSGIVING BECAUSE IT'S BEEN FANTASTIC. AND IT'S VERY IMPORTANT. I DO HEAR WHAT YOU'RE SAYING BRENDAN BUT I FEEL LIKE IF WE WERE ABLE TO ADD INSTRUCTIONS FOR VIEWERS WHICH I THINK IS A GREAT IDEA, ONCE THE PUBLIC,& SCIENTISTS LEARNED ABOUT THAT, THEY WOULD COMPLAIN THAT IN 12 PAGE THIS IS IS HARD TO GET RIGHT SO I'VE CONCLUDE THAD SOME SORT OF CALLED OUT AREA THAT COULD BE OPTIONAL OR COULD BE MANDATORY AT LEAST 1 OF THESE BELOW OR ABOVE THE LINE AS WE DECIDE IS REALLY GOING TO BE IMPORTANT BECAUSE YOU ALSO DON'T WANT TO SAY WE HAD ALL THESE DISCUSSIONS AND I THINK THAT THIS IS 1 TECHNOLOGY TRANSFER WHERE YOU WANT TO SAY, WE PUT SOMETHING ON THE LINE AND COMMITTED TO IT AS AN IMPORTANT THING AT THE SAME LEVEL HAS HUMAN SUBJECTS, AS RADIOLOGICAL MATERIALS AS INCLUSION OF DIVERSE GROUPS, I THINK YOU WANT TO MAKE THIS AT LEAST FOR THE SHORT NEXT 5 OR 10 YEARS, I THINK THIS SHOULD BE ON PEOPLE'S MINDS. >> SORRY CAN I? >> THANK YOU. I WANTED TO ADDRESS DR. LEE AND DR. WELSH YOURSELF SIR. >> I'M WITH NINDS, SO YOU RAISE VERY IMPORTANT POINTS ABOUT WILL THIS MAKE A DIFFERENCE AND YOU KNOW THE ROLE OF REVIEW. AND IN MY PERSONAL OPINION, THE MOST IMPORTANT ASPECT OF THE CHANGES IN THE REVIEW CRITERIA IS THE FIRST 1 WHICH WAS SCIENTIFIC PREMISE WHICH IS ILL DEFINED BUT REALLY REFERS TO THE RIGOR OF THE SUPPORTING DATA. AND IF YOU THINK WITH ABOUT IT IF INVESTIGATORS KNOW THIS WILL BE REVIEWED, THEN IN THEIR PUBLICATIONS THEY WILL MAKE SURE IT'S DONE CAREFULLY SO CAN YOU GET INTO THE CYCLE WHERE EVERYONE'S PAYING ATTENTION TO IT BECAUSE WHEN THE PROPOSED EXPERIMENT YOU CAN PROPOSE WHAT YOU WANT AND THEN NOT DO IT BUT IF YOU COME BACK IN AND YOUR PAPERS AREN'T VIEWED AS YOU CAN'T JUSTIFY THAT THEY ARE RIGOROUSLY DONE, THEN YOU'LL BE DINGED. SO THE SCIENTIFIC PREMISE IS A TO GET AND ACHIEVE THESE ISSUES THAT YOU RAISE AND IF THAT HAD A SEPARATE SECTION, THAT WOULD GO A LONG WAY IN MY OPINION. >> MANY OF YOU MAY NOT KNOW BUT IN THE INTEREST OF UPPER CITATION BEFORE O. E. R. TOOK THIS ON FOR IMPLEMENTATION, SHYANN STORY LANDIS WERE THE LEADERS AT NIH IN THE WHOLE FIELD SO HE IS 1 OF THE PARENTS OF THIS WHOLE RENEWED EFFORT SO THANK YOU SHY FOR ALL OF WHAT YOU DO. >> I THINK THAT THE IMPORTANT POINT IS THE EDUCATION PART. AND AS RICK LIFTON POINTED OUT, DIFFERENT RESEARCH IS DIFFERENT AND IN THE PAPER YOU WROTE STORY LANDIS, I PAID PARTICULARLY ATTENTION TO THE DISCOVERY PART OF SCIENCE. SO WHAT YOU'RE TALKING ABOUT, IS PRETTY EASY FOR ME TO WRITE IF I'M GOING TO GO IT A CLINICAL TRIAL. A LOT OF THINGS I WRITE IN A GRANT, I SAY I'M GOING TO DO THIS, TURNS OUT I END UP DOING SOMETHING ELSE BECAUSE THE SCIENCE TOOK ME IN THAT DIRECTION. SO YOU STILL HAVE TO HAVE THAT RIGOR, OF COURSE, BUT IT'S AN EDUCATIONAL KIND OF THING. I AM ALWAYS RELUCTANT TO PUT ON ADDITIONAL REGULATIONS. WE NEED TO LET--LET PEOPLE KNOW WHAT OUR EXPECTATIONS ARE BUT THE REAL TEST OF THIS COMES AT THE JOURNALS. AND YOU KNOW, WHEN I WRITE A GRANT, I END UP THINKING I WILL DO THIS, WHERE IT TAKES ME OVER TO HERE, YOU CAN'T GO BACK AND CHECK, DID I DO EQUAL NUMBERS OF BOTH GENDERS OR WHATEVER, I THINK THIS IS--THIS S&P KNOWING WHETHER OR NOT WE MADE A DIFFERENCE CAN BE IMPORTANT IN THE TRAINING BUT I THINK WE'RE GOING TO HAVE A REALLY HARD TIME AND IT'S REALLY, THE RUBIER WILL MEET THE ROAD AT THE JOURNALS, AND SO, DO WE HAVE ANY CONTROL OVER THE JOURNALS, I KNOW YOU'VE HAD DISCUSSION WITH THE JOURNALS BUT THAT'S WHERE THE REAL TEST WILL BE. >> IT'S ABOUT THE TRANSPARENCY REALLY. IF YOU HAVE A LIST OF PAPERS THAT YOU USING IN SUPPORT OF WHAT YOU WANT TO DO AND THEY DO NOT INCLUDE INFORMATION ABOUT IF THE STUDIES WERE DONE CAREFULLY AND IF MEASURES WERE TAKEN TO ELIMINATE UNCONSCIENCE BIAS, HOW CAN YOU DECIDE THAT THEY ARE GOOD ENOUGH TO SUPPORT YOUR WORK? WHAT YOU ARE PROPOSING TO DO? THE PROBLEM WITH THAT COMES IS WE DON'T LOOK CAREFULLY ALWAYS WHEN WE'RE REVIEWING A GRANT. WE DON'T REAMLY LOOK CAREFULLY AT WHAT THAT PERSON HAS DONE BEFORE AND THAT'S JUST THE FACT. >> I THINK YOU MIGHT HAVE BEEN ASKING SOMETHING DIFFERENT. WHICH IS IF THE PAPERS ON WHICH THE GRANT IS PREDICATED CLAUSE, WE WOULD BE ASKING THE REVIEWERS TO GO BACK AND LOOK AT THE ORIGINAL SOURCE MATERIAL THAT'S USED TO GENERATE HYPOTHESIS IN THE APPROACH AND THAT BECOMES VERY COMPLICATED AND A SUBSTANTIAL BURDEN. I LIKE THE IDEA OF TALKING ABOUT TRANSPARENCY, I LIKE IDEA OF TALKING ABOUT RIGOR, MY SENSE--MY SENSE OF THIS IS THAT THE GRANT REALLY SHOULD STAND ON ITS OWN. YOU SHOULD BE ABLE TO MAKE A STRONG CASE FOR YOUR APPROACH AND YOU SHOULD BE ABLE TO, YOU KNOW WHERE ELVANT, RICK'S POINT IS WELL TAKEN ABOUT HOW YOU WILL MAKE DECISIONSAMPLE SIZE, YOU KNOW WHETHER IT'S ANIMALS OR PEOPLE DOESN'T APPLY TO EVERYTHING. BUT I REALLY FAVOR MAKING AN INTEGRAL PART OF THE GRANT. I THINK IT'S GREAT TO CALL IT OUT AND MAKE IT IMPORTANT, I'D BE OKAY WITH EXTENDING IT TO 13 PAGES, YOU KNOW? >> YOU'RE RIGHT, I MEAN IT'S--YOU CAN'T EXPECT RIGHT NOW AT LEAST THE RULES, YOU CANNOT TELL THE REVIEWERS TO GO AND READ BACKGROUND INFORMATION BUT THE RULE--WHAT IT SAYS NOW IS THAT THE INVESTIGATOR IS REQUIRED TO DIZZ CUSS THE STRENGTH OF THE RESEARCHERS THAT ARE THERE USED AND WHEN I SAY SEPARATE SECTION ALL I WAS CALLING FOR IS JUST TO HAVE A PARAGRAPH WITH A HEADING. SO IT'S CLEAR THAT IT'S BEING DISCUSSED AND ADDRESSED. >> OF COURSE THERE ARE MANY AREAS OF RESEARCH, THIS MAY NOT APPLY, BUT IN FOR EXAMPLE, IN CERTAIN AREAS OF CLINICAL RESEARCH, THERE ARE PUSHES TO REQUIRE, PUT THAT IT QUOTES, SYSTEMATIC REVIEWS TO JUSTIFY DOING SOMETHING. SO FOR EXAMPLE, AT PC ORI, WHERE THEY ARE DOING OUTCOME RESEARCH, THEY WANT--THEY LOOK MUCH MORE FAVORABLILY UPON A PROPEZZAL THAT WOULD--PROPOSAL THAT WOULD SAY A SYSTEMATIC REVIEW WAS DONE ON THIS TOP AND I CAN A CLEAR RESEARCH GRAPHS WAS IEKS DENTIFIED AND THIS PARTICULAR QUESTION HAS NOT BEEN ANSWERED. THIS OBVIOUSLY DOES NOT APLOY TO MANY AREAS OF RESEARCH BUT TO SOME AREAS OF RESEARCH IT DOES. AND THERE ARE SOME THOUGHT LEADERS OUT THERE WHO SAYING THAT FOR THOSE AREAS OF RESEARCH, WE, MEANING THE ENTIRE ENTERPRISE SHOULD BE MORE--SHOULD BE MORE CAREFUL ABOUT INSISTING ON LOOKING AT THOSE SYSTEMATIC REVIEWS AS TO GET A BETTER SENSE OF WHAT THE REAL RESEARCH GAPS ARE. >> I WOULD JUST AGREE WITH WHAT MICHAEL WAS SAYING THAT KIND OF--BRENDAN BROKE IT DOWN IN 3 PLACES WHERE YOU HAVE AN IMPACT. THE PLACE WHERE IT SEEMS LIKE THE MAXIMAL IMPACT COULD BE HAD IS AT THE TRAINING LEVEL. TEACHING SOMEONE TO FISH, RATHER THAN CHECKING THEIRISHING OF THIS OF THIS CHECKING THEIR FISHING LINE EVERY TIME THEY FISH FOR THE REST OF THEIR LIVES. THE WAY I HAVE SEEN THE RESPONSIBLE CONDUCT COURSE WORK THAT BUILT IN, TENDS TO BE RELATIVELY SUPERFICIAL IN THE EXAMPLE COMPARE TO WHAT I COULD IMAGINE 1 DOING, WHICH IS JUST MANY MORE POSITIVE AND NEGATIVE EXAMPLES OF RIGOROUS OR UNRIGOROUS RESEARCH, YOU KNOW 1 TECHNOLOGY TRANSFER WE LACK, I THINK IN SCIENCE IS LIKE A MORBIDITY AND MORTALITY REPORT WHERE YOU CAN FRANKLY DISCUSS WHERE YOU WENT WRONG AND NOT BE NECESSARILY PENALIZED FOR IT. I CAN IMAGINE THINGS LIKE THAT BEING BUILT INTO TRAIN NOTHING A WAY THAT WOULD--YOU KNOW EFFECT PEOPLE HOW PEOPLE THOUGHT ABOUT THEIR SCIENCE AND BECOMING THE KIND OF SCIENCE THAT KICK THE TIRES FOR THE REST OF THEIR LIVES. >> SO JAY, YOU MAY BE AWARE OF THIS BUT NIH PUT SOME RESOURCES TOWARDS THIS SO THERE IS AAGE RELATED TO RIGOR, REPRODUCIBLE DEFINED BY SEARCHING THE NIH HOME PAGE. THERE MAY ACTUALLY BE A LINK ON THE HOME PAGE. SO ON THERE ARE SOME VIDEOS WITH WHICH I THINK ARE PRETTY WELL DONE, I DON'T STAR IN ANY OF THEM. [LAUGHTER] SPECIAL MEANING FOR ME BECAUSE OF WHAT WILL HAPPEN TOMORROW BUT ANYWAY, BUT WITH MATERIALS FOR TEACHING SO THAT IT CAN BE DONE AT THE LEVEL OF LAB OR LEVEL OF THE DEPARTMENT OR IT COULD BE DONE, YOU KNOW AS IA COURSE OR INSTITUTION, GM HAS SUPPORTED EFFORTS TO CREATE CURRICULA, I DON'T KNOW JOHN IF YOU WANT TO COMMENT ON WHERE THAT EFFORT IS AT THE MOMENT? >> SO WE'VE HAD SEVERAL EFFORTS. WE SPONSORED AN R25 FOA FOR THE DEVELOPMENT OF SHAREABLE TRAINING MODULES, THESE ARE ONLINE MODULES, WE HAVE A SPOT ON OUR WEBPAGE, IT HAS ALL THE RESOURCES, LARRY TALKED ABOUT PLUS THE PRODUCTS OF THESE MODULES AND WE'RE GETTING READY TO REISSUE THAT FOA IN A TARGETED FORMAT. WE'VE ALSO HAD 2 ROUNDS OF SUPPLEMENTS TO OUR T32 TRAINING GRANTS TO ALLOW THEM TO DEVELOP NEW CURRICULA AND IDEAS IN RIGOR AND REPRODUCIBLE RESEARCH TRAINING. >> IF YOU TYPE INTO GOOGLE NIH GRANTS RIGOR, ALL THOSE LINKS WILL COME UP. >> AND THEN MICHAEL HOSTED SEVERAL WORKSHOPS, HE BROUGHT IN LIEWMINARYS FROM EITHER THE INTRAMURAL OR EXTRA MURAL WORLD TALKING ABOUT THE MORE SOPHISTICATED TECHNOLOGIES, NOT TO TELL YOU ABOUT THE GREAT RESEARCH BUT TO TELL YOU WHAT COULD GO WRONG. SO YOU KNOW THINGS LIKE CRYOOR MASS SPEC OR SO FORTH, SO I DON'T KNOW IF YOU WANT TO--NJEA, WE ACTUALLY HAD A SERIES OF 5 DIFFERENT SYMPOSIA ON AREAS OF CURRENT RESEARCH INTEREST IN WHICH THERE'S A LOT OF DATA PROCESSING AND IN WHICH PEOPLE WHO ARE NOT NECESSARILY SOPHISTICATED ARE USING THE TECHNOLOGIES, THESE ARE ALL POSTED. THEY'RE AVAILABLE-- >> WHO ALL WEBCASTING IN THE ARCHIVES. >> RIGHT. >> SO THEY'RE ALL AVAILABLE, POTENTIALLY I THINK ANYONE ENTERING THE FIELD, IF THEY WANT TO DO MASS SPEC OR KRIST O EM COULD BEN FRIT FROM LEARNING ON ALL THE THINGS THAT CAN GO WRONG, THERE WAS 1 ON FACTS ANALYSIS WHICH IS MOST OF THE PUBLISH WORK DOESN'T MEET THE HIGHEST STANDARDS OF PEOPLE IN THE FIELD. >> ON THAT NOTE I AGREE AND IT'S MANDATORIA TOREXPE WE HAVE TO DO IT, I JUST DON'T THINK IT'S ENOUGH. I JUST WANT TO SAY BECAUSE, YOU KNOW WHETHER OR NOT YOU LIKE THE STUDY OR WHETHER OR NOT THAT PARTICULAR STUDY WAS REPRODUCIBLE, 1 THIS I THINK THAT LED TO THIS WAS THE REPORTTRYING TO REPLICATE NIH FUNDED WORK AND NOT BEING ABLE TO AT A HIGH RATE. SO 1 OF THOSE QUESTION SYSTEM THAT IF ANYBODY DOES IT AGAIN IN A BETTER DESIGN, BETTER EXECUTED WAY, WE WOULD HOPE THAT THE NUMBER OF REPRODUCIBLE STUDIES WOULD GO UP AND I THINK THAT THE EDUCATION WILL GET US MORE REPRODUCIBLE STUDIES IN 20 YEARS OR 10 YEARS BUT I THINK WE HAVE TO HAVE SOME ACTIONS IN THE NEXT SEVERAL YEARS TO AT LEAST INCREASE THE PROBABILITY THAT A REPEAT OF THAT STUDY MIGHT BE AND THAT STUDY BY THE WAY OF COURSE, IT HAD FLAWS AND PEOPLE CRITICIZED IT BUT THAT TYPE OF THING SHOULD GET BETTER OVERTIME, NOT STAY THE SAME. >> ALL OF YOU ARE EITHER EDITORS ARE REVIEWERS OF JOURNALS, I'M SURE PRESTIGIOUS JOURNALS YET THERE'S STILL STUFF THAT'S BEING PUBLISHED THAT'S JUST RUBBISH. IT'S STUNNING THAT JOURNALS PUBLISH [INDISCERNIBLE]. TALK ABOUT BASIC SCIENCE, NOT TALKING ABOUT A CASE REPORT. [LAUGHTER] IT'S JUST RUBBISH, AND YET--I DON'T WANT TO CAST ANY ASPERSIONS ABOUT 1 WORD JOURNALS BUT YOU KNOW, COME ON. SO SO WE COLLECTIVELY ARE BOTH PART OF THE SOLUTION BUT WE MAY ALSO BE PART OF THE PROBLEM. >> SO RUSS USED THE TERM MANDATORY BUT I'M HESITANT TO SAY THIS BUT JUST LIKE I HAVE TO PASS CITY TRAINING FOR CIT, TRAINING FOR IRB, CREDENTIALING OR OCCUPATIONAL SAFETY PASSING TESTS, THAT TYPE IN ORDER TO CONTINUE TO HAVE MY STATUS AT MY OWN INSTITUTION, SHOULD NIH JUST HAVE THIS ON A WEBSITE BUT ASK INVESTIGATORS TO ACTUALLY CERTIFY THAT THEY'VE DONE IT AT LEAST ONCE A YEAR OR ONCE EVERY SO OFTEN. >> PUT ON THAT HAT THAT I SOMETIMES HAVE TO WEAR. YOU KNOW THE GRANTS ARE NOT GIVEN TO YOU, THEY'RE GIVEN TO YOUR INSTITUTION AND YOUR EN--STRATEGIES TUITION--WHERE'S BARBARA, ARE YOU PROUD OF ME BARBARA? [LAUGHTER] WHEN IT DOUBT GO TO OGC. SO IT'S REALLY THE INSTITUTIONAL RESPONSIBILITY, ALTHOUGH I LIKE WHERE YOU'RE GOING WITH THAT. YOU KNOW, BUT IT WOULD BE INTERESTING TO HEAR THE REACTION OF THE PEOPLE. >> I LIKE WHERE YOU'RE GOING IN THE CONCEPT OF HAVING A TRAINING PROGRAM THAT'S MEANINGFUL. I WILL SAY BEING IN THE GOVERNMENT WHERE YOU HAVE TO DO 1 OF THESE WEB-BASED TRAINING PROGRAMS EVERY 3 DAYS ON SOMETHING, AND IT'S USUALLY REALLY BADLY DONE AND YOU CAN QUICKLY FIGURE OUT HOW TO GAME IT, I PROBABLY SHOULDN'T BE SAY THANKSGIVING IN A PUBLIC FORUM--[LAUGHTER] -- >> PLEASE REWIND THE TAPE AND DELETE. >> [LAUGHTER] >> YEAH, THERE MAY BE BETTER FORMATS THAN WHAT'S TRADITIONALLY USED FOR THIS KIND OF CERTIFICATION THAT YOU'RE SUPPOSED TO GET EVERY YEAR. >> OKAY, THIS HAS BEEN VERY HELPFUL AND WE WILL SYNTHESIZE THE DISCUSSION AND GET BACK TO THE MEMBERS OF THE COMMITTEE AND I THINK WE ARE IN VERY GOOD SHAPE TO HAVE A FINAL REPORT WELL BEFORE A YEAR FROM NOW. SNRVETION THANK YOU MIKE. APPRECIATE EVERYBODY'S COMMENTS AND WE WILL NOW TAKE A BREAK. WE'RE ACTUALLY A LITTLE AHEAD OF SCHEDULE SO WE'LL GIVE YOU A LONGER BREAK. WE WILL RECONVENE AT 3:15. >> WELCOME BACK EVERYBODY. WE ARE NOW GOING TO HAVE A COUPLE DISCUSSIONS THAT HAVE THE COMMON THEME OF THE 21st CENTURY CURES ACT--THIS WILL BEGIN WITH THE INCLUSION OF MARIE AND DAWN ARE GOING TO PRESENT TO YOU AND THEN WE WILL MOVE INTO A PRESENTATION ABOUT REGENRATIVE MEDICINE WITH GARY GIBBONS ON THE PHONE AND AMY PATTERSON TO MAKE THE PRESENTATION, LET ME INVITE MARIE BERNARD WHO'S AT THE PODIUM TO KICK THIS OFF. MARIE, THE FLOOR IS YOURS? >> GOOD AFTERNOON. I'M MARIE BERNARD AND WITH JANINE CLAYTON I CO CHAIR THE TRANS NIH INCLUSION GOVERNMENTS COMMITTEE AND DAWN CORBETT OUR INCLUSION POLICY OFFICERS ALSO OUR PARTNER IN CRIME IN TERMS OF PROVIDING TO YOU AN UPDATE ON THIS NEW 21st CENTURY CURES ACT MANDATE. WHAT WE HOPE TO DO IS TO REVIEW STEPS THAT WE'RE TAKING TO IMPLEMENT REQUIREMENTS IN THE 21st CENTURY CURES ACT WITH REGARDS TO AGE, PARTICIPANTS PARTICIPANTS AND CLINICAL RESEARCH, AND SO THE BACKGROUND IS, AND YOU ARE AWARE THAT WE'VE HAD INCLUSION POLICIES HERE AT NIH FOR MORE THAN 30 YEARS, VERY SPECIFICALLY POLICY RELATED TO AGE, FIRST CAME ABOUT IN 1998, WHEN NIH ISSUES A POLICY REQUIRING THE INCLUSION OF CHILDREN AND NIH CLINICAL RESEARCH AND THEN IF 2015 THAT POLICY WAS ALTERED TO CHANGE THE DEFINITION OF A CHILD FROM AN INDIVIDUAL 20 AND UNDER TO AN INDIVIDUAL 17 AND UNDER, MORE IN KEEPING WITH WHAT SEEMED TO BE CLINICALLY RELEVANT. AND THEN, DECEMBER 13th, 2016, THE 21st SEBTRY CURES ACT WAS SIGNED WHICH HAD NEW REQUIREMENTS WITH REGARDS TO AGE. VERY SPECIFICALLY, IT CALLED FOR NIH TO CONVENE A WORKSHOPY AGE GROUPINGS AND RESEARCH WITHIN 180 DAYS OF THE ACT BEING SIGNED AND TO POST THE WORKSHOP FINDINGS ON NIH WORKSHOP. IT ARC DITIONAL CALLS FOR DALTA OF AGE OF PARTICIPANTS ON CLINICAL RESEARCH INCLUDING PEDEIAM RICK SUBGROWNS AND FINALLY IT CALLED FOR THE NIH DIRECTOR TO DETERMINE WHETHER INCLUSION GUIDELINES ON AGE NEEDED TO BE REVISED WITHIN 180 DAYS OF THE WORKSHOP BEING COMPLOATED. NOW THIS DID NOT TAKE US TOTALLY BY SURPRISE, THE TRANSNIH INCLUSION GOVERNANCE COMMITTEE HAD BEEN LOOKING AT A NUMBER OF ISSUES, SEX, GENDER, RACE ETHNICITY AND LAST MANY YEARS INCLUSION OF PEDIATRIC AGE POPULATIONS AND OLDER POPULATIONS AND IN FACT, WE HAD BEEN THINKING ABOUT A SCIENTIFIC WORKSHOP FOR A COUPLE OF MONTHSS BEFORE THIS ACT WAS PASSED ALTHOUGH THE ACT DID ACCELERATE THE PACE OF WHICH WE PLANNED THAT WORKSHOP. SO, VERY SPECIFICALLY WE HAD A WORKSHOP HERE ON CAMPUS JUNE 1st AND 2nd, IT WAS WITH A VERY BROAD CHARGE TO LOOK AT THE OPPORTUNITIES AND THE BARRIERS TO THE INCLUSION OF PEDIATRIC AND OLDER POPULATIONS IN CLINICAL STUDIES AND NOT JUST FOR NIH BUT FOR THE SCIENTIFIC COMMUNITY AS A WHOLE. AND TO THINK ABOUT STRATEGIES THAT WOULD PRODUCE MORE INCLUSIVE STUDIES. WE HAD ABOUT 200 PARTICIPANTS, INCLUDING PEOPLE IN PERSON AND PEOPLE BY VIDEO CONFERENCE INCLUDING PEDIATRICIANS, GERIATRICIANS, STATISTICIANS AND JOURNAL EDITORS, DEPUTY EDITOR OF NEW ENGLAND JOURNAL AND THE DEPUTY EDITOR OF THE JOURNAL OF AMERICAN MEDICAL ASSOCIATION AS AS OTHER REPRESENTATIVES BECAUSE OUR THOUGHT WAS THAT THIS IS A PROBLEM FOR THE ENTIRE SCIENTIFIC COMMUNITY AND WE WANTED TO THINK VERY BROADLY ABOUT THINGS THAT WOULD BE HELPFUL TO ALL. THERE WERE PODIUM PRESENTATIONS FOR THE FIRST SEVERAL HOURS OF THE MEETING, AND THEN, THERE WERE BREAK OUT GROUPS, 1 FOCUSING ON STUDY POPULATIONS, ANOTHER 1 ON ETHICAL ISSUES, 1 ON STUDY DESIGN AND STILL ANOTHER ON DATA COLLECTION AND REPORTING. AND THESE WORK GROUPS HAD GOTTEN STARTED TO THE MEETING AS WELL, THEY HAD SEVERAL TELECONFERENCES SO THE IN-PERSON MEETING JUNE 1st OR 2nd WAS A CULMINATION OF THOSE TELECONFERENCES, AND ALLOWED THE SECOND DAY OF THE MEETING TO BE FOCUSED ON REPORT OUTS FROM THOSE WORK GROUPS IN TERMS OF THINGS, AGAIN, OPPORTUNITIES BARRIERS AND STRATEGIES. SO THERE ARE A NUMBER OF THEMES THAT WERE IDENTIFIED AND APPLICABLE, AGAIN NOT JUST TO NIH BUT OTHER GOVERNMENT RESEARCH ENTITIES AND THE SCIENTIFIC COMMUNITY AS A WHOLE. THE VIDEOCAST CAN BE FOUND AT THE URL THAT'S LISTED THERE, AND YOU HAVE IN YOUR BINDERS A SUMMARY OF THE WORKSHOP FINDINGS AND THE THEMES THAT WERE IDENTIFIED. WE ADDITIONALLY PUT OUT AN RFI TO,A LOW A BROADER PART OF THE SCIENTIFIC COMMUNITY TO BE INVOLVED, IN CASE PEOPLE WEREN'T ABLE TO MAKE IT JUNE 1st OR 2nd, THIS OPENED UP ABOUT 6 WEEKS BEFORE THE CONFERENCE OR THE WORKSHOP TOOK PLACE AND WAS OPEN THROUGH THE END OF JUNE. AND ALLOWED A NUMBER OF SCIENTIFIC ORGANIZATIONS AND A FEW INDIVIDUALS WHO ADDITIONALLY PROVIDE INPUT WHICH ENDED UP BEING COMMISERATE WITH THAT THAT IS FOUND OF THOSE PEOPLE WHO ATTENDED THE WORKSHOP IN PERSON. SO IN KEEPING WITH THE INPUT FROM THE WORKSHOP AND INTERNAL DISCUSSIONS, THE THEMES THAT ARE IDENTIFIED, THE WAY GOING FORWARD WAS BROUGHT TO THE INSTITUTE DIRECTOR'S MEET NOTHING EARLY NOVEMBER AND A GUIDE NOTICE WAS ISSUED DECEMBER 1 IN KEEP ING WITH EXPECTATIONS FOR THE 21st CENTURY CURES ACT THAT THE NIH DIRECTOR INTENDED TO REVISE THE POLICY ON INCLUSION ACCORDING TO AGE. AND THE PROPOSED POLICY CHANGES ARE THESE: THAT THE INCLUSION OF CHILDREN POLICY BE REVISED TO APPLY TO INDIVIDUALS OF ALL AGES, AGAIN, FOR PEDIATRIC AGE POPULATION FOR OLDER POPULATIONS AS WELL AND THAT AS RESEARCHERS ARE SUBMITTING PROPOSALS FOR NEW PROJECTS ARE COMPETITIVE RENEWALS, WE'RE PROPOSING THIS WOULD BE EFFECTIVE JANUARY 2019 THAT AGE RANGE MUST BE JUSTIFIED SCIENTIFICALLY AND/OR ETHICALLY THAT THEY WOULD BE NO REASON FOR AN ORBCONTRARY AGE CUT OFF AT THE LOWER RANGE AND THE UPPER RANGE. WE'RE ALSO RECOMMENDING THAT CLINICAL RESEARCH STUDIES SUBMIT INDIVIDUAL LEVEL DATA ON SEX GENDER, RACE ETHNICITY AND AGE AT ENROLLMENT TO ALLOW BETTER UNDERSTANDING OF HOW THOSE DEMOGRAPHIC VARIABLES ARE DISTRIBUTED ACROSS STUDIES, THIS WOULD OF COURSE REQUIRE THAT RESEARCHERS, WHEN CONSENTING SUBJECTS MAKE THEM AWARE THAT THIS POTENTIALLY PERSONALLY IDENTIFIABLE INFORMATION IS GOING TO BE SHARED, AND IT WOULD BE INCUMBENT UPON US TO TREAT IT AS PIOOH, IN A--PII IN A PROTECTED FASHION. SO FROM OUR PERSPECTIVE, THE NEXT STEPS AFTER DISCUSSION WITH YOU WOULD BE PUBLICATION OF THE EXPH PROVIDE IT TO YOU AND YOUR BOOKLET AND IN KEEPING THE 21st CENTURY CURES EXPECTATIONS AND PUBLICATION OF A NEW LIFE SPAN POLICY IN THE NIH GUIDE IN KEEPING WITH WHAT I JUST MENTIONED WITH INDIVIDUAL LEVEL DATA AND JUSTIFYING AGE RANGES SCIENTIFICALLY AND ELGTICALLY. --ETHICALLY. SO BEFORE TAKING YOUR QUESTIONS, I WILL ASK DR. CLAYTON AND MISS KOSHIT TO JOIN ME AND THE 3 OF US WILL BE HAPPY TO ANSWER QUESTIONS YOU MIGHT HAVE. THANKS MARIE AND THIS IS NOW OPEN FOR DISCUSSION BY THE ACD FOR THE NEXT STEPS THAT YOU SEE THERE AS WELL AS PROPOSED REVISIONS FOR CHILDREN. COMMENTS, CONCERNINGS, QUESTIONS? BRANDON? >> AS I UNDERSTAND IT, THIS WAS DRIVEN SOMEWHAT BY THE DESIRE BY THE PEDIATRIC COMMUNITY TO UNDERSTAND HOW CHILDREN ARE BEING STUDIED AND WHAT THE IMPACT IS, WHAT DO YOU SEE AS THE NEXT STEP, AFTER WE COLLECT THESE DATA AND HOW CAN WE USE IT GOING FORWARD? >> THANKS IN TERMS OF THE INDIVIDUAL LEVEL DATA, LET ME START BY SAYING WE'VE BEEN COLLECTING DAT ON SEX AND GENDER RACE ETHNICITY FOR QUITE SOMETIME ABOUT 20 YEARS AND WHAT WE HAVEN'T COLLECTED BEFORE IS DATA ON AGE WHEN COLLECTING INDIVIDUAL LEVEL DATA WILL ALLOW US TO DO UNDERSTAND MORE ABOUT THE INTERSECTION OF AGE WITH OTHER VARIABLES LIKE RACE AND EGHT INISSITY AND SEX OR GENDER WHICH IS NOT SOMETHING WE'VE BEEN ABLE TO DO IN THE PAST, SO I THINK WE'RE LOOKING AT THIS, AS A FIRST STEP TO GET DATA ON STUDY POPULATIONS, THAT CURRENTLY DON'T HAVE AND UNDERSTAND THE LANDSCAPE AND I THINK BASED ON THE INFORMATION WE HAVE, WE WILL REEVALUATE AT THIS POINT AND SEE IF ADDITIONAL STEPS ARE NECESSARY. >> I THINK IT'S FAIR TO SAY THAT THE IMPETUS BEHIND THIS WHILE IT MAY BE SOMEWHAT COMING FROM PEDIATRIC RESEARCH COMMUNITY IT'S COMING MORE FROM ADVOCATES. THAT'S BEEN MY IMPRESSION OF THOSE WHO BELIEVE THAT CHILDREN HAVE NOT BEEN INCLUDED IN RESEARCH STUDIES AT THE LEVEL THAT THEY WOULD LIKE TO SEE HAPPEN; THAT'S BEEN PARTICULARLY TRUE OF THE PEDIATRIC CANCER ADVOCACY COMMUNITY BUT NOT JUST--OTHER COMMENTS? I WANT TO SAY SOMETHING ABOUT THIS WHOLE QUESTION ABOUT HOW THEN TO TO TRY TO TRACK AGE WHEN YOU'RE TALKING ABOUT CHILDREN UNDER 18. OBVIOUSLY, THEY MIGHT BE AT A CERTAIN AGE WHEN THEY ENROLL IN A STUDY AND THEN, MAYBE THE TIME GOES BY, SO IS IT AGE OF ENROLLMENT, AGE OF DIAGNOSIS, AGE CONCLUDING OF THE STUDY, DO YOU TRY TO ACTUALLY HAVE AGE IN YEARS AND MONTHS OR DO YOU SORT OF PUT THESE INTO 3 YEAR INTERVAL BUCKETS. WHAT'S YOUR THOUGHT ABOUT HOW THAT MIGHT PLAY OUT? , THAT'S RIGHT. THERE ARE A NUMBER OF WAYS THAT AGE COULD BE COLLECTED AND SO WHEN WE STARTED LOOKING AT HOW TO COLLECT IT WE LOOKED AT WHAT OTHER REPOSITORIES WERE DOING AND DECIDED THAT COLLECTING AGE AT ENROLLMENT MADE THE MOST SENSE FOR A NUMBER OF REASONS. ONE WE AVOID THE ISSUE OF COLLECTING BIRTH DATE WHICH IS CONSIDERED PIOOH, AND THEIR POTENTIAL PRIVACY ISSUES. AND IT ALLOWS US TO HAVE A STANDARD MEASURE WHICH WE CAN APPLY TO ALL STUDIES. WE RECOGNIZE THATTED HAVES MAY BE ENROLLED IN THE STUDY FOR A NUMBER OF YEARS BUT BY COLLECTING AGE AT ENROLLMENT AND WE CAN UNDERSTAND FOR ALL STUDIES WHAT THE AGE OF THE PERSON WAS WHEN THEY STARTED PARTICIPATION IN THIS STUDY. IT LOOKS LIKE THERE WAS A LOT WORK IN THIS WE APPRECIATE YOUR EFFORTS IN THIS, THERE WAS ACKNOWLEDGMENTS AND THANKS WITH ALL THOSE PEOPLE, THAT WOULD BE LOVELY I'M SURE THEY WOULD APPRECIATE IT. >> WE ADDED A FEW ADDITIONAL SLIDES SO I WILL JUST SAY, THAT YOU HAVE IN YOUR FOLDER A LISTING AT THE END OF THE WORKSHOP SUMMARY, THE 200 OR SO PEOPLE WHO ATTENDED THE WORKSHOP, THE PEOPLE WITHIN NIHOT PLANNING COMMITTEE FOR THIS ENDEAVOR, THE ORGANIZATIONS THAT RESPONDED TO RFI AND WE ARE VERY GRATEFUL TO ALL. IN PARTICULAR WE WOULD LIKE TO ACKNOWLEDGE DR. JANEAT KIN SON, DR. JANE STUDIES OF MULTIPLE ENDOCRINIA, DR. JIM GRIFFIN, DR. LISA KAIZ ER AND DR. JEROME LOCKET IN MY OWN INSTITUTE WHO REALLY CARRIED THE WEIGHT IN TERMS OF MAKING THIS WORKSHOP OCCUR TO THEIR CREDIT. IT CONSIDERED 2 WEEKS BEFORE THE 180 DAY DEADLINE. >> ALL RIGHT, JUST IN IF I'M. THANK YOU. AND THE STATEMENT BY THE NIH DIRECTOR THAT THIS NEEDED TO BE RECONSIDERED ALSO OCCURRED BEFORE THE DEADLINE BUT PRETTY CLOSE. AND AGAIN, WE WILL FOLLOW UP ON THAT WITH THE SPECIFICS. WELL, THANK YOU. LET'S CONTINUE THEN WITH THE OTHER ITEM UNDER THIS 21st CENTURY CURES ACT FOLLOW ON WHICH IS REGENRATIVE MEDICINE IS GARY GIBBONS ON THE PHONE? >> YEAH I'M HERE FRANCIS CAN YOU HEAR ME OKAY. >> S I CAN, DO YOU WANT TO INTRODUCE THE TOPIC AND THEN I GATHER AMY WILL DO THE PRESENTATION. >> SOUNDS GOOD. >> OKAY, GO AHEAD. >> YES SO IT'S MY PLEASURE TO PROVIDE AN UPDATE TO THE ACD REGARDING REGENRATIVE MEDICINE COMPONENT OF THE 21st CENTURY CURES INNOVATION FUND. WE OBVIOUSLY CAME BEFORE YOU WITH REGARD TO FY17, PLANS TO EXECUTE RATHER RAPIDLY IN THE 6 MONTH TIME WINDOW SUPPLEMENTAL AWARDS THAT AMY WILL TOUCH UPON BUT WE ALSO COME TO YOU NOW AS AN UPDATE AT A PIVOTAL MOMENT WHERE WE'VE JUST COME OFF THE HE'LLS OF WHAT I FOALT WAS AN EXCITING WORKSHOP, COLLABORATIVELY TO NIH AND FDA, KICKED OFF BUT NOT ONLY BY NIH DIRECTOR AND DR. COLLINS BUT ALSO SCOTT GOTTLIEB, BUT PART OF THE FDA PARTNERSHIP THAT IS VERY MUCH A CENTERPIECE OF THIS 21st CENTURY CURES INITIATIVE AND IT'S A TEAM OF COLLABORATIVE PARTNERSHIP THAT I REPRESENT 12 ICs TODAY AS PART OF OUR EFFORTS TO KEEP A SEAMLESS APPROACH TO COLLABORATION AND MEDICINE ACROSS THE NIH ENTERPRISE. THAT THING WE HOPE WILL ALSO CARRY INTO THE FY18 PLAN AND IT'S WITH THAT INTRODUCTION THAT I WILL LEAVE IT TO DR. PATTERSON, THE CHIEF SCIENTIFIC ADVISOR TO PROVIDE WUFURTHER DETAILS OF OUR ACTIVITIES AND WHAT WE SEE AS POTENTIAL FOR FY18 AND BEYOND TO EXTEND THAT COLLABORATIVE PARTNERSHIP MODEL. DR. PATTERSON,. >> THANK YOU DR. GIBBONS, DR. COLLINS, DR. TAKEN--THEY DR. TAKEN--THEY--IT, ABAK, IT'S A PLEASURE TO BE HERE ON BEHALF OF OVER A DOZEN EN--STRATEGIESITUTES ACROSS THE AGENCY THAT HAVE COME TOGETHER IN A VERY EXCITING AREA AND ALSO WORKING WITH FDA TO HELP ADDRESS THE ISSUES REERATED TO PATIENT SAFETY AND PUB LIBRARY FOUNDATION TRUST IN THIS EXCITING FIELD. JUST LIKE TO TAKE A MOMENT TO TO REFRESH OUR MEMORIES ABOUT WHAT THE 21st CENTURY CURES SAYS ABOUT REGENRATIVE MEDICINE AND THERE ARE ACTUALLY SEVERAL PROVISIONS AND THEY APPLY VARIOUSLY TO FDA, NIST, AND NIH. AND ON THE 1 HAND, TAKEN TOGETHER, THESE PROVISIONS ARE A CESTAMENT TO CONGRESS' RECOGNITION OF THE GROWING PROMISE OF THIS FIELD, IT'S A GROWING PROMISE TO OFFER TREATMENTS AND POTENTIALLY AND ULTIMATELY CURES TO A WHOLE HOST OF DISORDERS. BUT AT THE SAME TIME, THOSE PROVISIONS ARE ALSO A TESTAMENT TO THEIR CONCERN, THAT THERE HAVE BEEN A NUMBER OF UNAPPROVED, UNSAFE AND INEFFECTIVE THERAPIES QUOTE-UNQUOTE GIVEN TO PATIENTS UNDER THE RUBRIC OF REGENRATIVE MEDICINE, SOMETIMES WITH TRAGIC CONSEQUENCES AND THEREFORE TAKEN TOGETHER, THESE THEMES REVOLVE--THESE ROUGH ATOM VISIONS REVOLVE AROUND A HANDFUL OF MAJOR THEMES AND THEY'RE LISTED ON THIS SLIDE. AGAIN, CONGRESS WANTS US TO PUSH AGGRESSIVELY PERIOD, RAPIDLY FORWARD IN DEVELOPING TREATMENTS AND CURES BUT THEY WANT THEIR CAKE AND THEY WANT TO EAT IT TOO, THEY WANT US TO DO SO WITH THE SCIENTIFIC RIGOR AND EVIDENCE BASE OR THOSE TREATMENTS AND CURES. THEY WANT TO CLARIFY AND WHERE POSSIBLE TO STREAMLINE THE REGULATORY OVERSIGHT AND PROCESSES FOR APPROVING AND EVALUATING APPROVING THOSE APPROACHES BUT AT THE SAME TIME, THEY DO NOT WANT FDA TO LOWER THE OVERSIGHT RIGORROR STANDARDS. AND THEN FINALLY IN RECOGNITION OF THE FACT THAT TO BRING A CLINICAL GRADE BY O LOGIC LOGIC--BIOLOGIC PRODUCT TO MARKET, MANUFACTURE IT, REGULATORY APPROVAL AND BRING IT TO MARKET IS A COMPLEX PROCESS OFTEN REQUIRES MULTIDISPLNARY EXPERTISE AND AS A GENERAL MATTER REQUIRES INDUSTRY ENGAGEMENT AND THEREFORE THE PROVISIONS IN THIS ACT, THAT ATTEMPT TO STIMULATE AND EVEN REQUIRE PARTNERSHIP AND INNOVATION. ALL OF THESE ARE A VERY IMPORTANT BACK DROP FOR THINKING ABOUT HOW WE CAN BEST MOVE FORWARD IN THIS SPACE AND FULFILL THE FERMS OF THE CONGRESSIONAL MANDATE. SO LET'S TAKE A LOOK AT WHAT THE PROVISION SPECIFICALLY ADDRESSES NIH SAYS: CONGRESS HAS INSTRUCTED US TO "WORK IN COORDINATION WITH FDA TOWARD GRANTS AND CONTRACTS FOR CLINICAL RESEARCH, FOR CLINICAL RESEARCH, TO FURTHER THE FIELD OF REGENRATIVE MEDICINE USING ADULT STEM CELLS AND TOWARD THIS END--I'M SURE YOU HEARD DR. COLLINS SPEAK ABOUT THE NIH INNOVATION ACCOUNT CREATED YOU SHOULD THE CURES ACT THAT INN CLUEDS OTHER PROJECTEDS LYKES PMI, AND CANCER MOONSHOT BRAIN AND THE REGENRATIVE MEDICINE INNOVATION PROJECT CONGRESS AUTHORIZED A TOTAL OF 30 MILLION TO BE DISTRIBUTED OVER A 4 YEAR PERIOD, STARTING OFF WITH 2 MILLION IN THE FY2017 AND DRIEWBTED THROUGH 2020 AS YOU SEE HERE. IN ADDITION, AGAIN IN RECOGNITION OF THE IMPORTANCE OF PARTNERSHIP AND ENGEAJING THE PRIVATE SECTOR IN THIS ARENA, THE ACT FURTHER STIPULATES THAT FOR EVERY FEDERAL DOLLAR PUT ON THE TABLE, THAT APPLICANT NEEDS TO BRING TO THE TABLE AT LEAST 1 NONFEDERAL DOLLAR. SO THERE'S A 1 TO 1 MATCHING REQUIREMENT CALLED FOR IN THE ACT. THIS EFFECTIVELY, IF YOU WILL DOUBLES THE THIRD MILLION INNOVATION ACCOUNT FOR REGENRATIVE MEDICINE TO 60 MILLION. AS DR. GIBBONS ALLUDED TO, NIH IMPLEMENTING THIS PROVISION OF THE ACT HAS TAKEN IT AS AN OPPORTUNITY TO COME TOGETHER IN A FOCUSED AND SYSTEMATIC WAY AS AN AGE TO TRY TO ADVANCE THE FIELD AND TO PROACTIVELY ENGAGE FDA IS THE RESEARCH COMMUNITY AND ADDRESSING SOME OF THE ISSUES PERTAINING TO PATIENT SAFETY, PUBLIC TRUST AND INSURING THE INTEGRITY OF CLINICAL RESEARCH IN THIS ARENA. FDA HAS BEEN AN OUTSTANDING PARTNER IN THIS REGARD, AND THEY'VE BEEN VERY ACTIVE ALL THE WAY FROM AT THE BEGINNING HAVING INPUT INTO THE IMPLEMENTATION WORK PLAN, THAT WAS DEVELOPED AND YOU ALL SAW A DRAFT OF THIS, EARLY IN THE YEAR, IT WAS SUBSEQUENTLY SUBMITTED TO CONGRESS DURING THE SUMMER, THEY THE--THE FUNDING OPPORTUNITY ANNOUNCEMENTS THAT SOLICITED THE PROJECTS OVER FY17 DURING THE SUMMER AND THEY'RE VERY ACTIVE PARTNERS AND THINKING ABOUT HOW WE CAN BEST APPROACH THIS PROJECT IN FY18 AND BEYOND. FOR FY17 WE WERE INTO THE FISCAL YEAR WHEN THE ACT PASSED AND THEY FURTHER IN THE YEAR WHEN WE GOT OUR APPROPRIATIONS AND THREFORE AS YOU MA I RECALL FROM OUR DISCUSSIONS WITH YOU, WE OPTED TO SPEND THE 2 MILLION IN FY17 IN THE FORM OF SUPPLEMENTS TO PREEXISTING PROJECTS. 12th IRNSITUTES CAME TOGETHER TO PREPARE 12 NOITP NOTICES OF INTENT TO PUBLISH AND 12 FOAs AND THESE AGAIN WERE DEVELOPED COLLABORATIVELY WITH FDA, THEY WERE SCOPED AGAIN IN KEEPING WITH THE SPIRIT AND LETTER OF THE ACT TO SUPPORT CELL BASED APPROACHES, ESTABLISHING AN EVIDENCE BASE FOR CLINICAL APPLICATIONS. SO THESE WILL BE IND PRIMARILY ENABLING STUDIES THAT WOULD ALSO ADDRESS GOOD MANUFACTURING PRACTICES AND HAD ALSO A NOTABLE FEATURE TO THEM AND THAT WAS THAT THEY WERE TO NOT ONLY ADDRESS THE INVESTIGATION HYPOTHESIS BUT ALSO TO OFFER POTENTIAL SOLUTIONS TO WELL RECOGNIZE CHALLENGES IN THE FIELD, SO THE INTENT HERE WAS TO TRY TO HAVE A PROJECT OR PROJECTS THAT WOULD FLOAT MANY IF NOT ALL BOATS. THIS IS THE TIMELINE OF EVENTS. YOU REVIEWED THE WORK PLAN IN MARCH AND BY END OF MARCH WE ISSUED A DOZEN NOTICES OF INTENT TO PUBLISH, A DOZEN FOAs, AT THE END OF APRIL, OVER THE SUMMER APPLICATIONS WERE RECEIVED AND IN AUGUST, A SPECIAL EMPHASIS PANEL OF SPECIFICALLY STRUCTURED TO REVIEW THESE APPLICATIONS, WAS CONVENED AND BY THE END OF SEPTEMBER, THE AWARDS WERE MADE. YOU WERE--AND WE'RE DEEPLY GRATEFUL TO YOU, ACTIVE THROUGHOUT THIS PROCESS AND IN PARTICULAR AND MOST RECENTLY YOU SERVED AS THE SECONDARY REVIEW BODY FOR THE REVIEW OF THE FY17 APPLICATIONS. YOU'RE ULTIMATELY ABLE TO FUND 8 APPLICATIONS FOR A TOTAL OF 2.7 MILLION IN FEDERAL DOLLARS. THAT CONSISTED WITH OF THE 2 MILLION OF THE INNOVATION ACCOUNT FOR FY17 AND AN ADDITIONAL .17 CONTRIBUTED BY RELEVANT INSTITUTES AND THERE ARE 4 IF YOU TAKE THE MATCHING REQUIREMENT 2.7 TIMES 2 IS 5.4 MILLION AND THAT WAS THE TOTAL INVESTMENT FOR THIS PROJECT IN FY17. YOU CAN SEE, SHOWN HERE ON THIS SLIDE, THE 8 PROJECTS REALLY SPAN A VERY BROAD RANGE OF SCIENCE AND NEW TECHNOLOGIES INCLUDING CRSPR CAS9, THEY ADDRESS COMMON DISEASES SUCH AS DIABETES, ANEMIA, CORNEAL DISEASES OF THE EYE, CHRONIC SKIN ULCERS BUT THEY ADDRESS RARE DISEASES INCLUDING PULL MONITORARY FIBROSIS AND INHIRIT THE ORDERS OF THE SKIN AND SICKLE CELL DISEASE, SOME OF THE APPLICATIONS ARE USING STEM CELLS THAT HAVE BEEN ENGINEERED WITH THE ULTIMATE AIM OF OBLIGATIONSVIATING OR REDUCING THE NEED FOR TRANSPLANT OR OTHERWISE RESTORING NORMAL FUNCTION, OTHERS ARE AIMED AT ENGINEERING A SUPPLY OF ERYTH ROUGH ATOM CITES OR PLATELETS IN THE LAB TO PROVIDE AN AVAILABLE AND SAFE SOURCE OF BLOOD PRODUCTS AVAILABLE FOR TRANSFUSION. >> IF I MAY, I THINK THIS WAS A REALLY GOOD EXAMPLE OF HOW THIS RELATIVELY MODEST PROGRAM CAUGHT THE IMAGINATION OF OTHER PARTS OF NIH AND ULTIMATELY WHAT WE WERE ABLE TO FUND WAS WELL OUTSIDE OF THE AMOUNT OF MONEY SPECIFICALLY DEDICATED TO THIS BY THE CURES ACT AND THAT'S CREDIT TO THE EN--STRATEGIESITUTE DIRECTORS WHO LOOKED AT WHAT WAS COMING THROUGH AND SAID, WELL WE COULD PROBABLY DO A LITTLE BIT MORE GIVEN THE STRECT OF--STRENGTH OF SCIENCE AND MUCH CREDITED IN WAY IN WHICH IT WAS CATALYTIC IN CREATING MORE MOMENTUM FOR REGENRATIVE MEDICINE AND PROBABLY THE CONGRESS THOUGHT THEIR COMPONENT OF THE CURES ACT WAS ABLE TO ACHIEVE. OF COURSE WE WOULD LOVE TO SEE THAT SAME CATALIAISONS CONTINUE IN 18 AND BEYOND AND I THINK THAT'S WHERE YOU'RE GOING NEXT BUT I DIDN'T WANT ANYBODY TO MISS THAT BECAUSE WHEN YOU WERE ON THE PHONE ON SEPTEMBER 14th , LOOKING AT THE REVIEWS, THAT WHOLE PROCESS OF FIGURING OUT HOW TO MAKE THIS EVEN MORE EXPANSIVE THAN WE THOUGHT WE COULD HADN'T QUITE TAKEN SHAPE, SO YOU'RE HEARING THIS NOW IN A WAY THAT WE WEREN'T ABLE TO TELL YOU BACK, BACK IN SEPTEMBER. >> EXACTLY AND I WILL JUST COMMENT THAT THE WHOLE BATCH OF APPLICATIONS THAT CAME IN, WERE SIMPLY OUTSTANDING AND I THINK, SO WE HAVE A LOT OF ANTICIPATION AND EXCITEMENT FOR WHAT WILL COME IN THIS FY18 AND BEYOND. IN THINKING ABOUT FY18 AND BEYOND, WE WANTED TO REACH OUT TO THE COMMUNITY AND THE COMMUNITY NOT ONLY BEING THE RESEARCH COMMUNITY, BUT INDUSTRY ISSUES PATIENT GROUPS, ADVOCACY GROUPS, FOUNDATIONS, IN A MORE SYSTEMATIC MANNER AND WE JUST--OUR FRESH COMING OUT OF A WORKSHOP THAT WAS HELD LAST WEEK ON DECEMBER 6 AND 7th, IT WAS DESIGNED MANY INSTITUTES ACROSS THE NIH, AND ALSO IN CLOSE PARTNERSHIP WITH FDA, WE HAD THE GOOD FORTUNE AS DR. GIBBONS MENTIONED TO HAVE DR. COLLINS AND FDA COMMISSIONER SCOTT GOTTLIEB, NOT ONLY GIVE OPENING REMARKYOU JOIN US FOR THE INTRODUCTORY SESSION AND SET THE TONE FOR A THOUGHTFUL AND SPIRIT THE MEETING. THE MEETING WAS ORGANIZED AROUND 6 AREAS OF CLINICAL MEDICINE THAT OFFER SOME PARTICULAR PROMISE AT THE MOMENT IN THE FIELD. YOU SEE THEM LISTED HERE. WHAT WAS INTERESTING ABOUT THE DISCUSSIONS WAS THAT FOR EACH OF THESE AREAS, THEY THEIR OWN PARTICULAR CHALLENGES, BUT THEY'RE ALSO WERE CORE RESOURCES NEEDS FUNDMENTAL CHALLENGES THAT WERE COMMON AND RESONATED ACROSS ALL CLINICAL AREAS AND I WILL JUST MENTION 1 AND THIS IS THE CONUNDRUM AT THE END OF THE DAY AND DIFFERENTIATION, DO WE HAVE THE CELL WE THINK WE HAVE? DO WE HAVE THE CELL WE WANT? HOW ACCURATELY CAN WE PHENOTYPE THAT CELL? CHARACTERIZE ITS FUNCTION? PRIOR TO TRANSPLANT, POST TRANSPLANT, HOW WELL CAN WE TRACK IT, INVIVO AND MONITOR IT? AND 1 OF THE QUOTES FROM THE MEETING WAS KNOW THY CELL WHICH WAS A PROFOUND STATEMENT ABOUT THE IMPORTANCE OF CELL AUTHENTICATION AND THE NEED FOR RIGOROUS SCIENCE IN THIS AREA. WE ALSO 2 REGULATORY SCIENCE SESSIONS, 1 FOCUSING ON PRODUCT DEVELOPMENT AND THE OTHER ON CLINICAL TRIAL DESIGN. ONE THING THAT WAS VERY CLEAR, COMING OUT OF THIS MEETING WAS THE NEED TO DEVELOP MULTIDISCIPLINARY MULTISECTOR IKSZ PETTER EASE IN COLLABORATIONS IN ORDER TO PROVIDE THE CORE INFRASTRUCTURE AND RESOURCES FOR VERY SOLID FOUNDATION IN THIS AREA TO MAKE SURE THAT THE PRODUCTS THAT ARE DEVELOPED OR WELL POISED TO MEET CLINICAL NEED AND SATISFY REGULATORY REQUIREMENTS AND ACTUALLY TO DR. COLLINS POINT SO WE HAVE THE REGENRATIVE MEDICINE INNOVATION FUNDS FROM CONGRESS, THEY'RE AUTOMATICALLY DOUBLED BY THE MATCHING FUNDS, WHEN OUR INSTITUTES LEAN IN, FOR RELEVANT PROJECTS IN THEIR MISSION AREA, WE FURTHER AMPLIFY THE IMPACT OF THAT INVESTMENT, BUT IT'S ALSO CLEAR THAT WE'RE GOING TO HAVE TO ENGAGE OTHER PARTS OF THE ECOSYSTEM HERE. INDUSTRY, OTHER FEDERAL AGENCIES INCLUDING D.O.D., STATE FOUNDATIONS AND FUNDING RESEARCH IN THIS AREA IN ORDER TO COME UP WITH THAT WILL REALLY SUPPORT THE TYPE OF RIGOROUS DISCONTINUES AND CLINICAL INVESTIGATION THAT'S NEEDED AND TOWARD THIS END, WE'VE BEGUN TO THINK ABOUT WHAT WE'RE TERMING A REGENRATIVE MEDICINE COOPERATIVE. AND HAVE BEGUN TO HAVE DIALOGUES WITH THE RELEVANT PARTNERS IN THE VARIOUS SECTORS TO TALK ABOUT AREAS OF MUTUAL INTEREST, AND THE CRITICAL PARTNERSHIPS IN COLLABORATIONS THAT WILL BE VERY IMPORTANT TO MOVE THIS SPACE FORWARD. NOT SIMPLY IN INCREMENTAL FASHION BUT A TRULY TRANSFORMATIVE FASHION. SO IN THINKING ABOUT FY18 AND BEYOND WE CONTINUE IN A CONSULTIVE AND COLLABORATIVE MOTE TO FUND THE BEST SCIENCE POSSIBLE WITH THE FOCUS ON INVESTIGATOR INIT WHYIATED PROPOSALS TO HAVE A DIVERSE PORTFOLIO BUT PER THE MANDATE OF THE ACT TO HAVE A STRATEGIC FOCUS ON THOSE AREAS THAT ARE WELL POISED FOR CLINICAL APPLICATIONS. INCLUDING STUDIES THAT DEMONSTRATE PROOF OF CONCEPT FOR CLINICAL APPLICATIONS. SO THESE WOULD INCLUDE BOTH IND ENABLING STUDIES AS AS CLINICAL TRIALS FOR THE NEW INVESTIGATOR PROJECTS. AND THEN FINALLY TO ACTUALLY GO AHEAD AND FORGE THOSE KEY PARTNERSHIPS IN COLLABORATIONS THAT WILL BE ESSENTIAL TO HAVE THE CORE RESOURCES AND INFRASTRUCTURE CRITICAL FOR THIS AREA. SO IN SUM, THIS PORTION OF THE 21 FORTCEPTORY CURED AS IT'S BEEN A MANDATE THAT HAS INSPIRED A TIMELY COMING TOGETHER TO REALLY GALVANIZE THIS FIELD, FOSTER MAJOR SCIENTIFIC ADVANCES BUT TO DO SO IN A WAY THAT THE SCIENTIFIC RIGOR THAT HOPEFULLY CAN INSPIRE AND MERIT PUBLIC TRUST IN THE FIELD. AND WITH THAT I WILL CLOSE. >> AMY, THANK YOU. [ APPLAUSE ] >> SO OPEN FOR DISCUSSION, YES, JOSE. >> SO 1 QUESTION. WHEN THE REGENRATIVE MEDICINE INNOVATION PROJECT FUNDS, ARE SUPPLEMENTED BY THE IC, DOES THE 1 TO $1 MATCHING FROM NONFEDERAL MATCHES FULFILLMENT OR ONLY TO--NYES, THE FULL AMOUNT. >> THEN IN YOUR CONCENTRIC CIRCLES, IT SOUNDS LIKE THE PURPLE AND THE NONMATCHING-- >> SHOULD OVER LAP. >> YES. >> YES, YES, EXACTLY. >> AND IF THE 2 MILLION THAT WERE SPENT IN FY17, SUPPLEMENTS FOR EXISTING GRANTS, HOW--HOW DO THOSE INVESTIGATORS ALL OF A SUDDEN MANAGE TO FIND A MATCHING PARTNER IN SUCH A SHORT PERIOD EMPLOY. DID EMPLOY. >> THAT WAS A CHALLENGE. >> EXCELLENT QUESTION. SO THE MATCHING REQUIREMENT WAS MET VARIOUSLY BY THE DIFFERENT INVESTIGATORS SOME WITH AN OUTSIDE PARTNER WITH WHOM THEY HAD EXISTING COLLABORATIONS WE INTERPRETED WITH OUR LEGAL COUNCIL THE MATCHING REQUIREMENTS TO ALSO BE ABLE TO BE FULFILLED THROUGH AN IN-KIND MATCHING FROM THE INSTITUTION, SO A FAIR PORTION OF OUR APPLICANTS MET THE REQUIREMENT IN THAT WAY WITH THE INSTITUTION LEANING IN AND COVERING THE COST. >> WANT TO SAY SOMETHING MORE ABOUT THE STATE BASE, PARTICULARLY CALIFORNIA BECAUSE SUM HAVE BEEN IN THIS SPACE FOR A WHILE AND WE'VE HAD PRODUCTIVE INTERACTIONHOW TO BE SURE WE'RE MAKING THE MOST OF THAT, I'M NOT SURE WHERE THAT STANDS NOW BUT ANYTHING YOU HAVE TO OFFER WOULD BE HELPFUL. >> DR. COLLINS IS REFERRING TO, WE HAD A 2 DAY MEETING OVER THE SUMMER WITH CALIFORNIA INSTITUTE OF REGENRATIVE MEDICINE, AND I HAD INDIVIDUAL BRIEFINGS WITH VARIOUS INTERESTED INSTITUTES AND A NUMBER OF PROJECTS HAVE SPUN OUT OF THAT, WE'RE CURRENTLY IN DIALOGUE WITH THEM, WITH REGARD TO--THEY ARE FUNDING CLINICAL TRIAL NETWORKS AND ALSO CELL PRODUCTION PLATFORM TECHNOLOGIES AND SO THERE'S AN INTEREST IN SEEING WHAT CAN BE DONE TOGETHER IN THAT SPACE. I'LL ALSO MENTION THAT THERE ARE SEVERAL OTHER STATE ORGANIZATIONS INCLUDING MARYLAND, WE'VE TALKED WITH THEM BRIEFED THEIR COMMISSION, THEY'RE VERY INTERESED IN SEEING WHAT WE CAN DO TOGETHER IN TERMS OF CO FUNDING PARTICULARLY WITH THE CLINICAL TRIAL APPLICATIONS. A LOT OF THE OTHER STATES SOME HAVE SMALLER PROGRAMS IN CALIFORNIA, BUT NONETHELESS, VERY KEEN INTERESTS, SO WE'RE ALSO WORKING TO TRY TO BRING THEM TOGETHER AROUND THE TABLE AND SEE IF WE CAN COME UP WITH THE STREAMLINED WAY FOR THE FEDERAL AND STATE PARTNERS TO WORK TOGETHER. YEAH? >> FOR THE NEW CELL MAEVERRING INSTITUTE THAT DEAN CAME AND GOT AWARDED WHICH IS A LOT OF MONEY AND HAS TO HAVE A HIEWNG INDUSTRY INTERACTION. >> EXCELLENT. >> HOW DOES THAT DOFF TAIL, BECAUSE THAT IS DIFFERENT THAN JUST A STATE KIND OF THING. >> IT'S ON OUR LIST TO TRY TO FIGURE OUT AS WELL, ANOTHER THING THAT WAS BROUGHT UP AT THE WORKSHOP AND IS ALSO SOMETHING THAT WE'RE THINKING ABOUT IS THE EXTENT TO WHICH WORK ON THE HUMAN CELLAT LAS PINTAS MIGHT BE EXTENDIBLE TO HUMAN STEM CELL ATLAS SO DEVELOPING MORE CHARACTER RESOURCES AND CHARACTERIZATION BROADLY TO THE FIELD AS ANOTHER RESOURCE. >> ONE COMMENT, IS THIS DOVETAILS REALLY WELL WITH SEVERE NEEDS IN THE TISSUE CHIPS COMMUNITY AS WELL BECAUSE THE SOURCES OF CELLS FOR THAT ARE ALL OVER THE MAP, THERE'S LESS RESOURCES THAN FOR THE REGENRATIVE MEDICINE TO DO THE CHARACTERIDESSATION, MANUFACTURING AND THIS WILL BE A HUGE BOOM TO THAT COMMUNITY AS WELL, AND IT WILL BE GREAT IF YOU CAN KEEP YOUR EYES ON THAT, I WOULD BE HAPPY TO TALK TALK TO BUT THAT. >> I WOULD LOVE TO FOLLOW UP, WE HAVE BEEN TALKING WITH BIOFAB WHICH IS A COLLECTION OF INDUSTRY GROUPS THAT HAVE COME TOGETHER UNDER THE D.O.D. FOR TISSUE ENGINEERING, BUT WOULD LOVE TO TALK TO AND YOU HAVE A FOLLOW UP CONVERSATION. >> OUT OF CURIOSITY CAN YOU SPEAK A BIT ABOUT THE GEOGRAPHIC DISTRIBUTION. I KNOW THERE ARE ONLY 8 AND THE LEADERSHIP OF THE GRANTS, IS IT MIDCAREER INVESTIGATORS, JUNIOR, MORE SENIOR, THINKING AHEAD TO OTHER CONVERSATIONS WE'RE HAVING? >> I WISH HIBROUGHT--WE HAVE A SLIDE THAT HAS A MAP THAT SHOWS THE DISTRIBUTION, IT'S PRIMARILY COASTAL, BI-COASTAL WITH AN EMPHASIS ON THE NORTHEAST BUT IF --A FEW ALSO ON THE WEST COAST AND MAYBE 1 IN THE MIDWEST. COLORADO. WITH REGARD TO THE STAGE OF THE INVESTIGATORS, I DON'T THINK WE HAD ANY ESIs IN THIS SPACE, WE DID DO THAT ANALIS AND WE WANT TO BE SENSITIVE TO IT MOVING FORWARD. I THINK THE--THERE'S A BIT OF A BIAS BECAUSE IT'S LEVERAGING PREEXISTING PROJECTS, LEVERAGING PEOPLE WHO WILL HAVE THE CONNECTIONS TO BRING THOSE MATCHING FUNDS TO THE TABLE, EITHER FROM WITHIN THEIR EN--STRATEGIES TUITION OR REACHING OUT. AND SO I THINK IT'S SOMETHING WE NEED TO BE ATTENTIVE TOO. >> THANK YOU FOR THE VERY USEFUL SUMMARY, ESPECIALENTIALLY LOOKING AT THIS SLIDE, THIS HAS FDA ALL OVER IT, CLINICAL TRIAL DESIGN, GMP, PLUS THE REGULATORY STUFF, WHAT DO YOU ANTICIPATE THE ROLE OF THE FDA IN THIS--IN THE NEXT YEAR AS YOU LOOK AT GIVING OUT 10 MILLION OF NEW AWARDS. PLUS ANOTHER 10. >> EXCELLENT QUESTION, SO SEVERAL FOLD. ONE IS, WE ESTABLISHED AN M. O. U. WITH THEM SO THAT ANYTHING WE FUND IN THIS SPACE, THAT WE'RE SURE IF AN IND, OR DDE IS REAR--IDE IS REQUIRED THEY CAN SEE THE APPLICATION AND THE SUPPLEMENTS THAT CAME IN, THEY SAT INOT PEER REVIEW TOTION SERVE AS TECHNICAL RESOURCE, YOU KNOW NOT THUMBS UP OR DOWN, BUT IF OUR VIEWERS HAD QUESTIONS. ALSO, ARTICULATING IN THE SOLICITATIONS WHAT WE'RE LOOKING FOR IN TERPS OF PRODUCT DEVELOP--TERMS OF PRODUCT DEVELOPMENT SO THEY'VE BEEN RIGHT AT THE TABLE IN TERMS OF DEVELOPING THE SOLICITATIONS, NOW WITH REGARD TO SOME OF THE--WE'RE THINKING ABOUT DEVELOPING POOR RESOURCES OR INFRASTRUCTURE, 1 OF THE THINGS THAT WAS VERY CLEAR FROM THE WORKSHOP THAT PEOPLE WANT IS THE ABILITY TO CONSULT FDA EARLY ON. AND SO I THINK THIS WILL BE--THIS THIRD ITEM HERE TO INTEGRATE OR BUILD IN AND THERE'S A COMMITMENT FROM FDA LEADERSHIP TO REALLY LEAN IN, IN THIS SPACE AND BE PROACTIVE. SO IT'S SOMETHING THAT YOU'RE EXACTLY RIGHT. IT'S VERY IMPORTANT. >> THANK YOU. THAT'S GREAT TO HEAR BECAUSE OBVIOUSLY THEY'RE GETTING READY OF A TSUNAMI OF ACTIVITY IN THIS AREA, THEY NEED TO BE INVOLVED AT THE VERY EARLY STAGINGS IT IS A MODEL FOR MANY THINGS, BEYOND REGENRATIVE MEDICINE WHERE THE FDA AT THE TABLE AND SOME ROLE COULD BE VERY USEFUL FOR TRANSLATIONAL SCIENCES MORE GENERAL. >> MICHAEL GOTTLIEB HAS BEEN VERY VOCAL ABOUT THE INTEREST IN DOING THAT, NOW HE INTERPRETS REGENRATIVE MEDICINE TO INCLUDE GENE THERAPY, INCLUDING SUCH THINGS AS CAR-T-CELL THERAPIES FOR CANCER SO IT'S A BROAD SPECTRUM OF ACTIVITIES THAT ARE ALL MOVING VERY FAST AND HAVE GREAT POTENTIAL BUT HAVE MADE FDA'S HEAD SPIN FROM TIME TO TIME. HE'S DETERMINED TO MAKE THIS AS A REAL OPPORTUNITY AND FDA ISSUED NO LESS THAN 4 GUIDANCES ABOUT REGENRATIVE MEDICINE ABOUT A MONTH AGO BOTH IN TERMS OF PROVIDING THIS ENCOURAGEMENT ABOUT HOW THEY'RE WILLING TO DO RAPID REVIEWS AND APPLY BREAK THROUGH DESIGNATIONS BUT ALSO MAKING IT VERY CLEAR THEY WILL CRACK DOWN ON THE KINDS CLINICS THAT ARE DOING THINGS THAT HAVE POTENTIAL REAL DANGERS ASSOCIATED WITH THEM AND THAT HAVE BEEN FLYING UNDER THE RADAR CLAIMING THEY WEREN'T MANIPULATING THE CELLS THEY'RE APLOYING WHEN IN FACT BY FDA STANDARDS THEY HAVE BEEN AND SO THERE'S GOING TO BE TROUBLE. THERE NEEDS TO BE TROUBLE IN MANY OF THOSE INSTANCES. COMMENTS OR QUESTIONS FOR AMY? OKAY, YOU'LL BE HEARING ABOUT THIS AS IT GOES FORWARD AS WELL. AMY, THANK YOU FOR A VERY CLEAR PRESENTATION. GARY THANK YOU FOR BEING ON THE PHONE. SORRY YOU CAN'T BE HERE IN PERSON, THANK YOU FOR THE TIME AND EFFORT YOU'VE PUT INTO THE LEADERSHIP OF THE REGENRATIVE MEDICINE ALONG WITH INSTITUTE DIRECTOR COLLEAGUES IN THIS INTERESTING SPACE. SO I THINK WE'RE A BIT AHEAD OF SCHEDULE, THERE'S NO SHAME IN THAT, SO AS LONG AS WE'RE MOVING ALONG, MAYBE WE WILL MOVE ALONG, AND COME TO AS I SAID THIS MORNING, THE ALWAYS ANTICIPATED REVIEW OF OUTSIDE AWARDS FOR ACD APPROVAL. AND ASSUMING THAT THAT DOESN'T TAKE TOO LONG, I HAVE A FEELING WE MAY BE ABLE TO GO INTO CLOSED SESSION EARLIER THAN ANTICIPATED. BUT NOT QUITE YET. SO LARRY, IT'S YOURS? , OKAY, THANK YOU. >> ALWAYS HARD TO FOLLOW THAT BUILD UP. [LAUGHTER] >> CAN YOU DO IT, CAN YOU DO IT! >> SO IF YOU WOULD DIRECT YOUR ATTENTION TO TAB 12, THIS LISTS THE AWARDS FOR THE ACDs REVIEW AND APPROVAL. JUST TO REMIND YOU, THE FEDERAL LAW PROHIBITS FEDERAL EMPLOYEES FROM RECEIVING ADDITIONAL MONEY DURING THE PERFORMANCE OF THEIR JOBS. SO AS A RESULT, WE HAVE TO VET EACH AWARD TO SEE IF IT'S BENAIFIED AND THERE ARE--BONAIFIED AND THERE ARE VERY STRICT CRITERIA THAT WE USE AND THESE ARE WORKED OUT, THIS IS NOT POLICY, THIS IS--IN STATUTE, AND THEY ARE PRESCREENED BY DR. LIFTON WHO'S GRACIOUSLY AGREED TO PARTICIPATE AS YOUR EMISARY TO THIS AND OF COURSE BY THE NIH ETHICS OFFICE. IF YOU--IF YOU TAKE A LOOK AND THERE ARE--THERE'S ENTRIES ON THE FRONT AND THE BACK OF THIS PAGE, THE AWARDS VARY IN THE AMOUNT. IT DOESN'T MATTER. THEY ALL HAVE TO FOLLOW THE SAME CRITERIA WHETHER IT'S FOR $500, TO A POST DOCTORAL STUDENTURAL FELLOW--POST DOCTORAL FELLOW TO SOMETHING AS SUBSTANTIAL AS A LASKER, AND EVERYTHING IN BETWEEN. NOW JUST IF ANYBODY IS CURIOUS, THE BREAK THROUGH PRIZE FOUNDATION WHICH IS QUITE SUBSTANTIAL WAS NOT AWARDED TO ANYBODY AT NIH THIS YEAR. WHAT WE DO HOWEVER IS AS NEW PRIZES BECOME KNOWN, WE PREVET THEM, THE EVENT Y'ALLITY IF ANYBODY FROM NIH IS AWARD TD SUCH A PRIZE, IT STREAMLINES THINGS GOING FORWARD AS OPPOSE TO GOING THROUGH THAT AWKWARD SITUATION OF WELL, CONGRATULATIONS, HOWEVER, YOU MAY NOT BE ABLE TO, YOU KNOW ACCEPT THE MONITORY AWARD, YOU MAY NOT BE ABLE TO ACCEPT THE METAL BECAUSE THE METAL IS REALLY MADE OF PRECIOUS METAL. >> BUT CAN HAVE A REAL HE NICE WOODEN PLAQUE. >> YES. >> FRANCIS! >> [LAUGHTER] SO THAT'S 1 OF THE FUN PARTS OF MY JOB, SO RICK, I DON'T KNOW IF YOU HAVE ANY COMMENTS TO MAKE ANY THE SET OF AWARDS YOU REVIEWED FOR US? >> SURE. I'LL JUST SAY THAT I THINK THE CRITERIA, ARE VERY CLEARLY ARTICULATED AND ALL OF THE AWARDS THAT HAVE COME ALONG IN THIS TERM EASILY PASSED THE MUSTER FOR PRESENTATION AND I'D LIKE AS A MEMBER OF THE LASKER JURY, I WOULD LIKE TO ADD MY CONGRATULATIONS TO DOUG LOWY AND DOUG SCHILLER ON THE WORK OF THE HPV VACCINE, I HAVE NOTHING TO ADD OTHER THAN NIH'S CRITERIA ARE CLEAR AND RIGOROUS AND ALL OF THE PROPOSED AWARDS HAVE PASSED THROUGH THOSE CRITERIA. >> GREAT. THANK YOU AND AGAIN I DO APPRECIATE ALL YOUR HELP BECAUSE I KNOW HAVE YOU A VERY BUSY DAY JOB. SO I DO APPRECIATE YOUR EFFORT. >> MY PLEASURE, THANK YOU. >> SO WITH RICK'S RECOMMENDATION AND THE RECOMMENDATION OF OUR ETHICS OFFICE, I WOULD ASK IF THE COMMITTEE HAS A MOTION? >> SO MOVED. >> SECOND? >> ANY DISCUSSION? >> WAS THE BREAK THROUGH PRIZE PREAPPROVED. >> IS THE BREAK THROUGH PRIZE PREAPPROVED. >> IF YOU AGREED TO IT. YES. >> THE RECOMMENDATION IS TO PREAPPROVE IT. >> CORRECT. YES, ANYTHING ON THE LIST WOULD BE APPROVED OR PREAPPROVED. >> OKAY. >> ALL THOSE IN FAVOR? >> AYE. >> OPPOSED? ANY ABSTENTIONS? THANK YOU. THAT WAS VERYENTIOUS--VERY EFFICIENT AS ALWAYS. APPRECIATE IT. >> WELL THEN BRAVO WE CAN COME TO THE END OF TODAY'S AGENDA ALTHOUGH WE HAVE WORK WE WILL BE DOING IN OPEN SESSION TOMORROW BEGINNING AT 9:00. BUT LET US NOW ADJOURN THE OPEN SESSION AND CLEAR THE ROOM FOR THE CLOSED SESSION WHICH WILL JUST BE ACD MEMBERS DR. TABAK AND MYSELF. WE ARE ADJOURNED.