CAPTIONS START IN A FEW MINUTES >> WELCOME, DR. MICHAEL LU, FROM THE HEALTH BUREAU. >> OKAY. SO IT'S MY PLEASURE NOW, AS IS OUR CUSTOM, FOR ME TO TELL YOU SOMETHING ABOUT WHAT'S BEEN HAPPENING AROUND NIH AND IN THIS CASE, NOT JUST NIH BUT THE DEPARTMENT OF HEALTH AND HUMAN SERVICES, ALSO NEW SPECIFICALLY FROM NICHD, SOME THINGS -- SOME COMINGS AND GOINGS, HONORS AND OTHER KINDS OF THINGS IN TERMS OF OUR STAFF, AND THEN WE SHOULD THINK ABOUT REVERSING THIS ORDER BECAUSE OFTEN THE LEGISLATIVE UPDATES ARE NOT THE MOST OPTIMISTIC AND INSPIRING PART OF THE PRESENTATION SO MAYBE IN THE FUTURE, WE SHOULD CHANGE THE ORDER. OR MAYBE WE SHOULD CHANGE THE BUDGET AND LEGISLATION INSTEAD. SO NEW FROM NIH AND HHS, YOU'LL SEE THAT WE TAKE A RATHER WIDE VIEW OF NIH HERE BECAUSE WE INCLUDE THE PRESIDENT OF THE UNITED STATES AS A PART OF NIH, WHICH WE'RE PROUD TO DO, AND THAT REALLY COMES FROM THIS ANNOUNCEMENT APRIL 2ND AT THE WHITE HOUSE THAT GOT A LOT OF, I THINK, APPROPRIATE ATTENTION IN BOTH THE LAY AND SCIENTIFIC PRESS, AT WHICH THE PRESIDENT ANNOUNCED THE SPRING INITIATIVE, WHICH IS OF GREAT INTEREST TO NIH AT LARGE BUT OBVIOUSLY FOR MANY REASONS OF GREAT INTEREST, NICHD SPECIFICALLY. I CAN TELL YOU, I WAS FORTUNATE ENOUGH TO BE ONE OF THE COUPLE HUNDRED PEOPLE IN ATTENDANCE, THERE WERE SOME OTHER FOLKS FROM COUNCIL ACTUALLY THERE AT THE WHITE HOUSE, WHEN THE PRESIDENT ACTUALLY ANNOUNCED THIS. A COUPLE THINGS REALLY STOOD OUT TO ME BESIDES THE FACTS INVOLVED, AND THAT IS, THE OBVIOUS PERSONAL ENTHUSIASM AND UNDERSTANDING THAT THE PRESIDENT HAD FOR THIS. THIS WAS NOT ONE OF THESE KINDS OF CEREMONIES WHERE THE SPEAKER JUST HAD A SCRIPT AND WAS SAYING GET OUT OF THE ROOM KIND OF THING. YOU COULD TELL HE WAS AD-LIBBING THINGS, YOU COULD TELL HE WAS REALLY INVESTED IN THIS. THE OTHER THING THAT WAS QUITE INTERESTING WAS -- AND THIS IS VERY UNUSUAL -- THE PERSON WHO INTRODUCED THE PRESIDENT OF THE UNITED STATES WAS ACTUALLY FRANCIS COLLINS. THAT WHILE THIS IS CLEARLY AND NEEDS TO BE A KIND OF AN ISSUE THAT GOES ACROSS THE FEDERAL GOVERNMENT, VERY IMPORTANTLY INVOLVING NSF, OTHER PARTS OF FEDERAL GOVERNMENT AND VERY MUCH PRIVATE PARTNERS, IT SAID SOMETHING THAT TO INTRODUCE THE PRESIDENT, INTRODUCE THIS, WAS THE DIRECTOR OF THE NIH. THIS IS NOT THE WAY IT'S USUALLY DONE. I CAN REMEMBER AN EARLIER EVENT AT THE WHITE HOUSE 10 YEARS AGO OR 13 YEARS AGO NOW WHEN THE PRELIMINARY DRAFT OF THE HUMAN GENOME HAD BEEN DONE, AND THERE WAS IN THE SAME ROOM IN THE WHITE HOUSE AN ANNOUNCEMENT THAT OF COURSE PRESIDENT CLINTON ANNOUNCED THAT THIS HAS BEEN COMPLETED, AND THAT WAS A THREE PERSON ON THE PLATFORM, IT WAS DR. COLLINS AGAIN, WHO WAS THEN HEAD OF NHGRI OF, KRIG VEN TORE, HEAD OF THE PRIVATE GROUP, YOU MAY REMEMBER IN THOSE DAYS WAS SORT OF RACING TO FINISH THE GENOME SEQUENCE, AND PRESIDENT CLINTON. FRANCIS TELLS THE STORY AS THEY WENT OUT TO ANNOUNCE THIS, THEY'RE WALKING DOWN THE CORRIDOR AND JUST AS THEY TURN THE CORRIDOR, JUST THE WAY THEY'RE TURNING, FRANCIS ENDS UP BEING IN FRONT. SO JUST AS THEY'RE ABOUT TO GO THROUGH THE DOOR, HE FEELS THIS HAND ON HIS SHOULDER. HE TURNS AROUND AND IT'S PRESIDENT CLINTON SAYING, FRANCIS, I BELIEVE I'M SUPPOSED TO GO FIRST. THAT'S USUALLY THE WAY IT'S DONE AT THE WHITE HOUSE. NOBODY INTRODUCES THE PRESIDENT OF THE UNITED STATES AT THE WHITE HOUSE. IT'S HIS HOUSE, YOU KNOW? SO THE FACT THAT IN THIS SITUATION THE DIRECTOR OF THE NIH WAS ASKED TO INTRODUCE HIM, I THINK CLEARLY WAS A SIGN, THERE HAVE BEEN OTHER SIGNS OF THIS AS WELL, THAT THE FEDERAL GOVERNMENT, THE WHITE HOUSE, SEES NIH AS REALLY BEING THE LEAD IN THIS MULTIAGENCY EFFORT. IT HAS WHAT MANY PEOPLE WOULD SAY IS A LOT OF MONEY, $110 MILLION, OTHERS WOULD SAY IS A FAIRLY MODEST BUDGET FOR SOMETHING THAT IS THIS AMBITIOUS. BUT THIS IS REALLY THE FISCAL YEAR '14 COMMITMENT WHICH AS YOU CAN SEE, $40 MILLION COMES FROM NIH, THE OTHERS FROM BUDGETS OF OTHER PARTS OF THE FEDERAL GOVERNMENT, AND THIS IS REALLY THE MONEY TO FIGURE OUT EXACTLY WHAT THE INITIATIVE SHOULD LOOK LIKE, WHAT SHOULD IT TAKE ON. IT'S THE IDEA OF REALLY TRYING TO PLAN THE SCIENCE CORRECTLY, AMBITIOUSLY BUT CORRECTLY, BEFORE WE GO OUT AND START SPENDING PRESUMABLY LARGER SUMS OF MONEY ON THIS. SO THERE IS ALREADY AN ADVISORY GROUP IN PLACE THAT'S BEGINNING TO DEFINE THE SCIENTIFIC GOALS, ESTABLISH WHAT THE RESEARCH PLAN SHOULD LOOK LIKE WITH LOTS OF CONSULTATION WITH OBVIOUSLY WHAT IS A VARIED AND WIDE REACHING COMMUNITY OF BOTH RESEARCHERS, POLICY, DISEASE ADVOCATES, ET CETERA, IN TERMS OF THINKING WHAT THIS SHOULD LOOK LIKE. BUT WE'RE HOPING IT'S THE KIND OF PROJECT THAT WILL TELL US INCREDIBLE THINGS ABOUT WHAT IS OF COURSE A VERY IMPORTANT PART OF HUMAN EXISTENCE, BUT ALSO DO IT IN A WAY THAT, FOR INSTANCE, EXCITES YOUNG PEOPLE ABOUT A CAREER IN SCIENCE AND OTHER THINGS LIKE THAT AT THE SAME TIME. SO YOU'LL BE HEARING MUCH MORE ABOUT THIS AS THE RESEARCH PLAN BEGINS TO BE DEVELOPED, AND I THINK WE'LL BE BRINGING IT OH YOU FOR YOUR INPUT. WE'VE CLEARLY MADE THE POINT, AND IT'S BEEN HEARD MANY TIMES, AND I THINK WE'VE ALREADY INCORPORATED THE THINKING IN THIS THAT ONE OF THE THINGS NICHD CARES ABOUT IN THIS IS TO STRESS THAT THE BRAIN IS NOT A STATIC ORGAN. THAT WE NEED TO BE DOING THIS WITH A DEVELOPMENTAL LENS, BOTH IN TERMS OF THE ISSUES OBVIOUSLY OF EARLY DEVELOPMENT THAT WE CARE ABOUT, BUT ALSO IN TERMS OF THE REHABILITATIVE ISSUES THAT WE CARE ABOUT AS WELL. AND THAT MESSAGE SEEMS TO BE GETTING ACROSS, BUT WE'LL BE CONTINUING AMONGST OTHER THINGS THAT WE'RE LOOKING AT THE RESEARCH PLAN ABOUT THOSE ARE SOME ISSUES THAT WE'LL BE CONTINUING TO MAKE SURE THAT THEY'RE AT THE FOREFRONT OF DOING THIS. MANY OF YOU KNOW THERE HAS BEEN A SECRETARY'S ADVISORY COMMUNITY ON INHERITABLE DISORDERS IN CHILDREN AND NEWBORN. THE CHARTER FOR THAT RECENTLY EXPIRED, RENEWED UNDER A SLIGHTLY DIFFERENT NAME FOR TECHNICAL REASONS, NOW THE DISCRETIONARY ADVISORY COMMITTEE ON HERITABLE DISORDERS IN NEWBORNS AND CHILDREN, PARTICULARLY FOCUSING ON QUESTIONS OF NEWBORN SCREENING, AS MANY OF YOU KNOW, NEWBORN SCREENING HAS TRADITIONALLY BEEN IN THE UNITED STATES A STATE BY STATE PROGRAM BUT THERE'S BEEN MORE OF A MOVE ON A STATE BY STATE BASIS TO HAVE SORT OF MORE NATIONAL GUIDELINES, FOR INSTANCE, AS TO WHAT KIND OF DISEASES SHOULD BE SCREENED, ET CETERA. IN MANY WAYS, THE LEAD AGENCY, BOTH FOR THIS COMMITTEE BUT FOR THINKING ABOUT NEWBORN SCREENING IN THE FEDERAL GOVERNMENT HAS LONG BEEN -- MATERNAL CHILD BUREAU -- BUT JUST AS THE RESEARCH, WE'VE BEEN VERY HAPPY TO PARTNER WITH THEM FOR DECADES ON THIS. I'M VERY HAPPY TO BE DESIGNATED ACCORDING TO CHARTER, DR. COLLINS IS FORMALLY A MEMBER OF THE COMMITTEE BUT THAT HAS BEEN DELEGATED TO THE DIRECTOR OF NICHD SO WE STAFF THAT AND THE COMMITTEE HAS DONE A LOT OF GREAT WORK, GLAD TO BE ABLE TO SEE THAT IT WILL CONTINUE TO DO THAT. THERE HAS BEEN A NEW DIRECTOR SELECTED FOR NIGMS, MANY OF YOU MAY HAVE HEARD ABOUT THIS, FOR THOSE WHO HAVEN'T, HE'S A PROFESSOR IN THE DEPARTMENT OF BIOPHYSICS AT JOHNS HOPKINS, AND WE'RE VERY EXCITED HE'S COMING. JON LORSCH. HE WILL BE STARTING THIS SUMMER AT NIH, I BELIEVE NEXT MONTH. WE'RE ALSO BOTH EXCITED AND HONORED THAT HIS LAB, HE HAS CHOSEN TO PUT HIS LAB WITHIN NICHD. HE'S PRACTICED FOR A NUMBER -- IF A DIRECTOR SHOULD WANT TO HAVE AN ACTIVE LAB AS DIRECTOR OF AN INSTITUTE, TO MAKE SURE THERE'S NO CONFLICT OF INTEREST IN MAKING BUDGETARY DECISIONS AND THOSE KINDS OF THINGS, THAT THAT LAB SHOULD BE IN ANOTHER INSTITUTE, AND PARTLY BECAUSE OF LONG-STANDING RESEARCH COLLABORATIONS WITH FOLKS WITHIN OUR INTRAMURAL PROGRAM, I THINK PARTLY BECAUSE OF THE EXCELLENCE OF OUR INTRAMURAL PROGRAM, DR. LORSCH HAS ASKED THAT HIS LAB BE PART OF OUR PROGRAM, AND WE'RE, AGAIN, HONORED TO HAVE IT. AND ALSO HAPPY BECAUSE HE DOES GREAT SCIENCE, SO IT'S NICE TO ADD THAT TO OUR LIST OF GREAT SCIENCE. NEWS FROM NICHD MORE SPECIFICALLY, WANT TO LET YOU KNOW THAT WE'RE CURRENTLY SEEKING A NEW CHIEF OF OUR PUBLIC COMMUNICATIONS BRANCH, THAT WE THINK THIS IS AN INCREDIBLY IMPORTANT POSITION HERE. JOHN MCGRATH HAD DONE THIS FOR MANY YEARS QUITE WELL, DECIDED TO RETIRE FROM THE FEDERAL GOVERNMENT, SO WE'RE LOOKING FOR A REALLY TOPNOTCH PERSON TO HELP US WITH THIS. THERE IS A LISTING IN THE USA JOBS.GOV IF YOU KNOW OF FOLKS WHO MIGHT BE GOOD AT THIS, PLEASE, PLEASE, PLEASE REFER THEM TO THE SITE, LET'S SOMEONE ON STAFF KNOW SO WE CAN COMMUNICATE WITH THEM HOWEVER YOU MIGHT DO, BUT OBVIOUSLY SO MUCH OF WHAT IS IMPORTANT TO OUR INSTITUTE IS NOT JUST DOING THE SCIENCE AND SUPPORTING THE SCIENCE, BUT COMMUNICATING ABOUT THAT WITH THE PUBLIC IN MANY KINDS OF WAYS. IF YOU THINK ABOUT THE SUCCESS OF THE BACK TO SLEEP CAMPAIGN, OTHER KINDS OF THINGS WE'VE DONE, PART OF THE REAL IMPACT WE'VE HAD ON HEALTH HAS BEEN BOTH WORKING WITH PARTNER ORGANIZATIONS BUT ALSO BEING VERY GOOD OURSELVES AT COMMUNICATING THAT. BEING ABLE TO PUT THE RESOURCES IN TERMS OF MONEY BUT ALSO IN TERMS OF ABLE PERSONNEL INTO SOME OF THOSE THINGS, I THINK LIKE ANY INSTITUTION, IF YOU KNOW CREATIVE FOLKS WHO MIGHT BE GOOD FOR THIS, PLEASE ENCOURAGE THEM TO APPLY, WE'LL BE HAPPY TO TALK WITH ANY OF THEM. TO LET YOU KNOW A COUPLE OF REPORTS FROM REALLY OUR INTRAMURAL PROGRAMS ARE NOW AVAILABLE ONLINE. IF YOU HAVE PARTICULAR INTEREST IN THESE, THEY'RE FASCINATING TO GET US THE IDEA OF BOTH THE SCOPE AND THE DEPTH OF THE SCIENCE THAT'S WITHIN OUR INTRAMURAL PROGRAM AND THE RELATED DIVISION OF EPIDEMIOLOGY STATISTICS AND PREVENTION RESEARCH, OR DESPR. BOTH OF THE ANNUAL REPORTS ARE AVAILABLE, AS YOU CAN SEE. JUST TO BRING UP SOME OF THE THINGS WE'VE BEEN UP TO, OF COURSE THERE HAVE BEEN SOME -- BECAUSE OF THE SEQUESTER, THERE'S BEEN SOME TIGHTENING OF OUR ABILITY TO HOLD CONFERENCES, ET CETERA, BUT NONETHELESS, LOOK AT THIS LIST OF CONFERENCES THAT WE HAVE HAD AN IMPORTANT PART IN ORGANIZING, ET CETERA, IN THE LAST FEW MONTHS, AND YOU CAN SEE THERE ARE A WIDE RANGE OF QUITE IMPORTANT TOPICS AND I CAN TELL YOU, HAVING HAD THE PRIVILEGE WITH PARTS OF SEVERAL OF THESE REALLY WONDERFUL KINDS OF CONFERENCES. IN TERMS OF STAFF ANNOUNCEMENTS, I'D LIKE TO EMBARRASS TWO LEADERS OF NICHD. FIRST OF ALL YVONNE, WHO WAS GIVEN AN HONORARY AWARD BY VIRGINIA UNIVERSITY, AN HONORARY DEGREE. THIS IS -- IT'S WONDERFUL, THIS IS WHERE SHE WENT AS A CHILD. SO TO HAVE THE PLACE WHERE YOU GROW UP, RECOGNIZE THAT YOU'RE A FULLY FORMED ADULT, SOMETHING WE'VE KNOWN FOR A LONG TIME, BUT TO HAVE THOSE WHO SORT OF HELPED MAKE YOU WHO YOU ARE, HELPED RAISE YOU RECOGNIZE THAT AS MANY OF YOU UNDERSTAND IS A PARTICULAR HONOR, SO WE'RE QUITE PROUD, NOT OF YVONNE, WE ARE PROUD THAT THEY WERE SMART ENOUGH TO RECOGNIZE HER, WHAT HER OUTSTANDING CONTRIBUTIONS HAVE BEEN AND CONSTANTINE STRATAKIS WAS GIVEN AN HONORARY HONORARY DEGREE BY THE UNIVERSITY IN BELGIUM, NOT A PLACE THAT RAISED HIM BUT A PLACE THAT RECOGNIZES HIS REAL CONTRIBUTIONS INTERNATIONALLY TO THE STATE OF SCIENCE. SO WE WILL BASK IN THEIR GLORY AND BE QUITE HAPPY FOR THEM. A LARGER COLLECTION OF STAFF -- I THINK THIS IS IMPORTANT, FROM THE NATIONAL DOWN'S SYNDROME SOCIETY RECOGNIZED NICHD STAFF AS, QUOTE, CHAMPIONS OF CHANGE, AND THIS REALLY HAS TO DO WITH THE IMPORTANT ROLE THAT THEY PLAYED IN BRINGING TOGETHER THE DOWN'S SYNDROME CONSORTIUM AND THE WORK THAT'S COMING OUT OF THAT CONSORTIUM, SO OBVIOUSLY UNDERSTANDING DOWN'S SYNDROME, BEING ABLE TO HAVE MORE EFFECTIVE APPROACHES TO DOWN'S SYNDROME FOR DECADES WITH NICHD'S MISSION, TO HAVE THIS RECOGNITION, I THINK IT'S WELL DESERVED FOR STAFF BUT ALSO CON ALSO WONDERFUL, YOU SEE THE FOLKS LISTED HERE. THEY PLAYED PARTICULARLY LEAD ROLES IN THIS, REALLY HAVE DONE A WONDERFUL JOB. ALSO FROM OUR CHILD DEVELOPMENT BEHAVIOR BRANCH, RECOGNIZED AS PART OF A TEAM WHO RECEIVED HH SI. INNOVATES, TO GIVE THIS AWARD TO REALLY RECOGNIZE INNOVATIVE APPROACHES TO ISSUES THAT WERE IMPORTANT TO THE DEPARTMENT, AND QUITE PROUD THAT LAYLA HAS BEEN A TEAM MEMBER OF THIS GROUP. SOME RECENT RETIREMENTS FROM NICHD SINCE WE LAST MET THAT YOU SHOULD BE AWARE OF, CAROLYN BONDE, LONG TIME MEDICAL OFFICER IN OUR INTRAMURAL PROGRAM, BOB BONNER ALSO A LONG TERM MEMBER OF OUR INTRAMURAL PROGRAM, PEGGY MCCARTLE, WHO YOU MAY HAVE KNOWN BETTER, FOR MANY YEARS SHE'S BEEN THE CHIEF OF THE CHILD DEVELOPMENT BEHAVIOR BRANCH, A REAL LEADER IN THE FIELD BOTH BEFORE AND DURING HER TIME AS CHIEF OF THE BRANCH, RECENTLY RETIRED, AND CAROL AN NICHOLSON, MEDICAL OFFICER IN NCMRR, PARTICULARLY INVOLVED IN THE PEDIATRIC INTENSIVE CARE NETWORK, HAS ALREADY RETIRED. COUPLE OF OTHER RETIREMENTS, WE'VE HAD ENOUGH RETIREMENTS WE COULDN'T PUT THEM ALL IN ONE SLIDE, A HEALTH SIG SCIENCE ADMINISTRATOR IN OUR IDD BRANCH HAS RETIRED, AS HAS BETH ANSER AT NCMRR. WONDERFUL PEOPLE AND MADE REAL CONTRIBUTIONS TO WHAT WE WILL DO. SO WE WILL MISS THEM BUT WE KNOW PART OF WHAT WE DO, WE'LL HAVE PEOPLE RETIRE AND GO ON TO VERY IMPORTANT CAREERS IN OTHER PLACES AND SOME OF WHOM WILL SIMPLY RETIRE. BUT THAT'S PART OF THE NATURAL ORDER OF THINGS AROUND HERE AND WE KNOW THERE WILL BE WONDERFUL PEOPLE COMING ON BOARD TO TAKE UP THE MANTEL. THIS ONE I WANTED TO MENTION, I WAS PARTICULARLY REMINDED AS I CAME AROUND THE CORNER THIS MORNING ON THE SIXTH FLOOR TO COME INTO THIS MEETING. IT'S UNUSUAL NOT FOR ME IN MY EXPERIENCE HERE NOT TO SEE AL OUT THERE RUNNING AROUND, GETTING THINGS DONE, ET CETERA. HE WAS SOMEONE WHO, BESIDES -- IMPORTANT ROLE AROUND HERE BUT PARTICULARLY FOR COUNCIL. AND SO MANY OF YOU GOT TO KNOW AL. THOSE WHO DIDN'T GET TO KNOW AL, THE FACT THAT YOU DIDN'T HAVE PROBLEMS HERE WAS OFTEN DUE TO HIS WORK. HE WAS REALLY A WONDERFUL GUY. A VERY VALUED MEMBER OF THE NICHD FAMILY WHO, AS YOU CAN SEE, DIED BACK IN JANUARY, AND WE REALLY DO MISS HIM. SO WE PROFIT FROM HIS BEING WITH US AND WE'RE SORRY THAT HE'S NO LONGER HERE. IN TERMS OF OTHER STAFF CHANGES, WE HAVE A DEPUTY DIRECTOR ADDED TO THE STAFF, DEAN, WHO IS A DENTIST BY TRAINING. HE'S HELD A NUMBER OF HIGH LEVEL POSITIONS IN THE DEPARTMENT OF HEALTH AND HUMAN SERVICES, THE OFFICE OF THE SURGEON GENERAL, AND JOINED US A FEW MONTHS AGO NOW AS THE DEPUTY DIRECTOR OF THE NATIONAL CHILDREN'S STUDY TO HELP WITH A LOT OF THE ORGANIZATIONAL AND OTHER ISSUES IN THE STUDY, AND ALSO HE'S REMINDED -- HE REMINDS US WELL THAT ORAL HEALTH IS THE KEY TO ALMOST ALL HEALTH AND MAKING SURE THAT WE INCORPORATE THAT WELL INTO THE STUDY AS WELL. IN TERMS OF BUDGET AND LEGISLATIVE UPDATES, I THINK YOU'RE PROBABLY AWARE OF SOME OF THESE NUMBERS BUT NOT OUT TO THE NUMBER OF DIGITS WE'RE SHOWING HERE, AND THAT IS, OF COURSE, SINCE WE LAST MET, WE HAVE RECEIVED THE FISCAL YEAR '13 APPROPRIATION FOR NIH IN GENERAL BUT SPECIFICALLY FOR NICHD, AND OUR APPROPRIATION IS $1.245 BILLION. OFFICIALLY. NOW, DEPENDING ON WHETHER YOU'RE A GLASS HALF FULL OR HALF EMPTY KIND OF PERSON, AFTER MANY YEARS OF STUDYING THIS, I'VE DECIDED THAT I'M A GLASS HALF EMPTY/HALF FULL KIND OF PERSON. THAT REPRESENTS REDUCTION OF ABOUT $75 MILLION OR 5.68% BELOW OUR FISCAL YEAR '12 APPROPRIATION. THAT'S THE GLASS HALF EMPTY PERSPECTIVE. THE GLASS HALF FULL VIEW IS WE HAVE ONE AND A QUARTER BILLION DOLLARS, WE OUGHT TO BE ABLE TO DO SOME PRETTY GOOD RESEARCH WITH THAT. MANY OF THE DECISIONS YOU'LL BE MAKING TODAY, WE NEED TO INCORPORATE THIS INTO OUR THINKING AND BE AWARE OF IT, STILL MOVE FORWARD. WE'RE RESOLUTE, AND I HOPE THIS COMES ACROSS AND I KNOW THAT AS WE TALK WITH YOU, THAT DESPITE THE DIFFICULT TIMES WE'RE IN, WE'RE NOT GOING TO STOP DOING NEW AND IMPORTANT SCIENCE. THAT THIS IS NOT A TIME TO ENTRENCH WHEN THE SCIENTIFIC OPPORTUNITIES ARE INCREDIBLE, WE NEED TO FORGE AHEAD AND CONTINUE TO DO REALLY CUTTING EDGE SI ENS. SCIENCE. THERE WAS VERY GOOD COORDINATION ACROSS THE NIH ABOUT WHAT KINDS OF DECISIONS REALLY NEED TO BE NIH-WIDE, BOTH BECAUSE IN TERMS OF FAIRNESS, IN TERMS OF PARTWAY THROUGH THE YEAR, DOING THINGS SO THE EXTRAMURAL COMMUNITY COULD UNDERSTAND EXACTLY WHAT WE WERE DOING RATHER THAN HAVING ONE INSTITUTE DO THIS, ANOTHER INSTITUTE DO THAT, A THIRD INSTITUTE DO A THIRD THING, ET CETERA. ON THE OTHER HAND, RECOGNIZING THAT THERE ARE SOME ISSUES THAT REALLY DID REQUIRE A SPECIFIC APPROACH BECAUSE OF DIFFERENCES IN THE SCIENCE, WHERE THE BUDGETARY SITUATION IS AT THE INSTITUTE, WHATEVER IT MIGHT BE, SO I THINK THERE WAS A NICE SORT OF HYBRID APPROACH OF SOME THINGS ACROSS THE NIH AND SOME THINGS LEFT TO THE INDIVIDUAL INSTITUTES IN TERMS OF NIH-WIDE FISCAL YEAR '13 FISCAL POLICY, THIS IS ALL POSTED ON THE WEB, HAS BEEN FOR SOME TIME, OBVIOUSLY LOGIC WOULD SAY, FEWER COMPETING AWARDS ARE LIKELY, AND THERE WILL NOT BE INFLATIONARY INCREASES IN FUTURE YEARS. IN OTHER WORDS, IF YOU GET AN AWARD, THAT IS THE LEVEL OF THE AWARD IN OUTYEAR, NO LONGER THE -- SEEMS LIKE SOME YEARS AGO, BUT NOT THAT LONG AGO, THAT IF YOU GOT AN AWARD FROM NIH, YOU COULD ASSUME THERE WOULD BE AN INFLATIONARY INCREASE IN THE OUTYEARS. THAT'S NO LONGER THE CASE. ADJUSTMENTS WILL BE CONSIDERED FOR SPECIAL NEEDS. SPECIAL NEEDS WILL REALLY BE QUITE SPECIAL. IT'S NOT BECAUSE WE NEED THE MONEY. IT'S BECAUSE OF SOMETHING THAT IS UNIQUE TO THAT SITUATION THAT REALLY WARRANTS SOME KIND OF INCREASE IN THE OUTYEARS. THIS WILL BE FAR FROM THE RULE, THIS WILL CLEARLY BE THE EXCEPTION, SO THAT ALL AWARDS SHOULD ASSUME THAT THEY WILL BE LEVEL FUNDED. NONCOMPETING CONTINUATION AWARDS, FISCAL YEAR '13, LIKELY BE FOUND AT LEVELS LOWER THAN THE ORNLG MAL ORIGINAL COMMITMENTS, WE WERE ISSUED AWARDS UNTIL WE GOT THE BUDGET NOT AT THE FULL LEVEL BUT AT LOWER LEVELS BECAUSE WE WERE AWARE THIS WAS PROBABLY WHERE WE WERE GOING TO END UP. U.SSUPPORT FOR NEW INVESTIGATORS WILL CONTINUE. IN ORDER TO CONTINUE TO ACHIEVE WHAT THE NIH HAS MADE AS THEY SORT OF BENCHMARK FOR THE LAST NUMBER OF YEARS TO HAVE SUCCESS RATES FOR NEW RO1s AND EQUIVALENTS TO BE BASICALLY COMPARABLE TO THOSE OF ESTABLISHED P.I.s, AND EACH INSTITUTE, IT'S UP TO THEM HOW THEY ACCOMPLISH THAT, BUT WE'LL BE TALKING MORE ABOUT THAT. AND A LOT OF THE FISCAL POLICIES THAT WERE IN PLACE IN FISCAL YEAR '12 IN TERMS OF STIPENDS, SALARY LIMITS, ET CETERA, ARE CONTINUING THE FISCAL '13 YEAR AWARDS. ANOTHER THING TO LET YOU KNOW ABOUT SINCE IT CLEARLY HAS AN IMPACT ON THE SCIENCE THAT WE NEED AROUND HERE IS THAT ANY APPROPRIATIONS -- GAVE US OUR BUDGET, TWO THINGS WE SAID SPECIFICALLY ABOUT THE NATIONAL CHILDREN'S STUDY. THERE WAS A SPECIFIC NUMBER GIVEN FOR THE BUDGET, WHICH IS THE WAY IT'S BEEN DONE FOR A NUMBER OF YEARS, THEY GET THE SPECIFIC BUDGET, JUST TO REMIND YOU IT DOES NOT COME OUT OF THE NICHD BUDGET, A LINE ITEM THAT GOES TO THE -- OF THE DIRECTOR OF THE NIH, HE ASKS US THEN TO LEAD THE STUDY FOR HIM, BUT THAT'S THE MONEY WE'RE GIVEN, $154.7 MILLION, AFTER THIS IS THE -- THIS IS THE EXACT TOTAL AFTER THE SEQUESTER. WE WERE ALSO ASKED, SINCE WE'RE ABOUT TO GET TO THE LAUNCH OF THE MAIN STUDY, WE ARE ASKING APPROPRIATIONS LANGUAGE TO HAVE A REVIEW BY THE IOM AND STARTING THE MAIN STUDY FOR AT LEAST 60 DAYS AFTER THAT REPORT HAS BEEN MADE PUBLICLY AVAILABLE SO THAT OBVIOUSLY IT WILL HELP SHAPE THAT FINAL STUDY DESIGN. WE HAVE ALREADY ENTERED INTO AN AGREEMENT WITH THE IOM, THEY'RE PUTTING TOGETHER THE PANEL TO DO THIS, WE ANTICIPATE THE PANEL FIRST MEETING PROBABLY IN SEPTEMBER, A AND WE ARE LOOKING FORWARD TO HAVING THEIR REPORT SOMETIME THE MIDDLE OF NEXT YEAR. SO WE THINK THIS WILL BE A GOOD OPPORTUNITY TO MAKE SURE THAT WE REALLY HAVE THE SCIENCE OF THIS OPTIMIZED BEFORE WE GET INTO THE -- OBVIOUSLY THE MAJOR PART OF THE NATIONAL CHILDREN'S STUDY, THAT IS THE MAIN STUDY. WHAT ABOUT FISCAL YEAR 2014? BOTH SO THAT WE'LL KNOW ABOUT THAT, BUT CERTAINLY SO THAT WE CAN THINK ABOUT THAT AS WE MAKE PLANS FOR THE FISCAL YEAR 2013 BUDGET. HOW WE USE OUR BUDGET THIS YEAR DEPENDS PARTLY ON WHAT WE EXPECT ABOUT FUTURE YEARS. WELL, THE PRESIDENT'S BUDGET REQUEST WHICH TRADITIONALLY GOES TO THE CONGRESS IN FEBRUARY, BECAUSE OF THE VERY UNUSUAL TERRAIN THIS YEAR, EVEN FOR USUAL, THIS WAS UNUSUAL, THAT WAS DELAYED UNTIL APRIL, AND THE PRESIDENT REQUESTED A BUDGET OF $1.339 BILLION FOR US, WHICH YOU'LL NOTE, OF COURSE, IS A PRETTY SIGNIFICANT INCREASE FROM $1.245 BILLION. IT'S OFTEN SAID AROUND WASHINGTON THAT THE PRESIDENT'S BUDGET REQUESTED BASICALLY DEAD ON ARRIVAL WHEN IT GETS TO THE CONGRESS BECAUSE THE CONGRESS PUTS ITS WILL UPON THAT. MANY OBSERVERS THIS YEAR SAID IT'S DEADER THAN USUAL ON ARRIVAL BECAUSE AGAIN WE FACE SUCH AN UNUSUAL FISCAL SITUATION IN TERMS OF THINKING ABOUT LONG-TERM IMPACT IN TERMS OF WILL THE SEQUESTER REMAIN IN PLACE, WHAT WILL HAPPEN WITH LARGER FINANCIAL ISSUES IN BOTH OUR ECONOMY AND FEDERAL BUDGET, ET CETERA, SO I'D SAY THAT WE REALLY DON'T HAVE A GOOD HANDLE AT THIS POINT, GOOD EXPECTATION OF EXACTLY WHAT OUR FISCAL YEAR 2014 BUDGET WILL LOOK LIKE. COULD BE ABOUT THE SAME AS WHAT WE HAVE THIS YEAR, COULD BE LESS. COULD BE MORE. BUT I THINK ANYONE WHO TELLS YOU THAT THEY REALLY KNOW WHAT'S GOING TO HAPPEN WITH ANY PART OF THE FEDERAL BUDGET FOR NEXT YEAR, I WOULD KEEP YOUR HANDS ON YOUR WALLET WHILE THEY TALK TO YOU BECAUSE NOBODY REALLY KNOWS. SO THAT DOES MAKE IT FOR ALL OF US WHO AROUND THE COUNCIL TABLE WHO TRY TO MANAGE THE BUDGET THAT WE HAVE, LET'S BE HONEST, IT MAKES IT MORE DIFFICULT THAN EVER TO HAVE BOTH A BUDGET WHICH HAS DECREASED AND ALSO NOT TO KNOW -- IT WOULD BE A MISTAKE FROM A STAFF POINT OF VIEW TO DO SOME THINGS WHICH YOU MIGHT DO IN ANOTHER SITUATION WHERE YOU'D SIMPLY SAY, GEE, OUR BUDGET HAS BEEN CUT THIS YEAR, SO THERE ARE SOME THINGS YOU CAN KIND OF DELAY UNTIL OCTOBER, THE START OF THE NEXT FISCAL YEAR, SO WHY DON'T WE JUST DELAY THEM UNTIL THEN, WHEN THE STORES GET REPLENISHED KIND OF THING. WE'LL BE HARVESTING AND HAVE THIS BOUNTIFUL HARVEST. WE DON'T THINK THAT'S A VERY GOOD MANAGEMENT DECISION AT THIS POINT. NOT KNOWING WHAT NEXT YEAR WOULD LOOK LIKE. SO WE'RE REALLY TRYING TO BE RESPONSIBLE STEWARDS AND USE THIS YEAR'S MONEY AS ABLY AS WE CAN. WE'LL BE TALKING MORE ABOUT THAT OVER THE COURSE OF THE DAY. OTHER THINGS IN TERMS OF LEGISLATIVE, LET ME ACTUALLY GO BACK TO ONE OTHER THING WHICH IS NOT ON THE SLIDE HERE BUT I DO WANT TO MENTION, WHICH IS AS YOU SAW BACK HERE, WE HAVE THIS 5.68% REDUCTION IN OUR FISCAL 2012 APPROPRIATION. THAT'S -- IN TERMS OF THESE THINGS THAT GO ACROSS THE NIH VERSUS THINGS THAT ARE SPECIFIC, THAT WAS TO GO ACROSS THE NIH. EVERYBODY HAD THAT DECREASE AT THE END OF THE DAY. HOW WE MANAGE THAT WAS REALLY IN THE FOLLOWING WAY. AS YOU KNOW, WE BASICALLY HAVE THREE PLACES WHERE WE SPEND MONEY AT OUR INSTITUTE, AND IT'S TRUE OF ALMOST ALL THE OTHER INSTITUTES. ONE IS OUR INTRAMURAL PROGRAM. TWO IS WHAT'S CALLED RMS OR RESEARCH MANAGEMENT SUPPORT PAYS FOR THE SALARIES OF NON-INTRAMURAL STAFF, PAYS FOR BRINGING YOU TO COUNCIL, THINGS LIKE THAT, CONFERENCES WE PUT ON, ET CETERA. AND THE THIRD POT, OVER 80% OF THE BUDGET, IS THE EXTRAMURAL SUPPORT THAT GOES TO FUND THE KINDS OF DECISIONS YOU'LL BE MAKING THIS AFTERNOON. WHAT WE DECIDED TO DO WAS TO SPREAD THIS 5.68% REDUCTION ACROSS THE WHOLE -- ALL THREE OF THOSE. FOR VARIOUS KINDS OF MANAGEMENT REASONS, FOR INSTANCE, IF YOU THINK ABOUT THE INTRAMURAL BUDGET OR THE RMS BUDGET FOR THAT MATTER, THE VAST PART OF THAT BUDGET IS REALLY KIND OF FIXED COSTS, THAT IS, ITS SALARY. NOW WE COULD HAVE HAD -- SOME FEDERAL AGENCIES DECIDED WE COULD HAVE HAD FURLOUGHS, WHERE WE TELL PEOPLE SEVEN DAYS, 14 DAYS, WHATEVER THIS YEAR, YOU WON'T WORK, YOU WON'T GET PAID. SO WE COULD HAVE REDUCED SALARIES THERE. BUT NIH-WIDE, THE DECISION WAS MADE THAT, A, THAT WAS BAD FOR SCIENCE. THAT PARTICULARLY BECAUSE OF THE TIGHT BUDGETS OVER THE LAST SEVERAL YEARS, MOST INSTITUTES ARE SHORT STAFFED AT THIS POINT, TO BE HONEST. SO TO REMOVE ALL STAFF FOR SEVEN OR 14 OR HOWEVER MANY DAYS IS GOING TO MEAN EVEN SHORTER STAFFED. SO WE REALLY THOUGHT JUST AS MANAGERS OF SCIENCE THAT THIS WAS A POOR DECISION TO MAKE. THE OTHER THING, OUR STAFF HASN'T HAD RAISES IN THREE YEARS. TO THEN SAY WE'RE GOING TO TAKE AWAY FOR SOME PEOPLE, YOU KNOW, MONEY YOU PAY THE MORTGAGE WITH, WASN'T A GOOD THING IN TERMS OF JUST PERSONNEL MANAGEMENT. NOW WE ARE ACUTELY AWARE THAT WE ALL ARE LUCKY ENOUGH TO HAVE JOBS. THERE ARE PEOPLE IN THIS ECONOMY WHO ARE NO LONGER EMPLOYED. THERE ARE PEOPLE WE KNOW IN EXTRAMURAL INSTITUTIONS THAT ARE HAVING TO CLOSE LABS, CUT THEM DOWN, ET CETERA. WE HAD SOME EFFECT ACROSS THE PLACE, WE REALLY SAW FURLOUGHS WERE NOT THE WAY TO GO. SO ONCE YOU'VE SAID THAT, IT'S MUCH HARDER TO DO, AGAIN, HALFWAY THROUGH THE YEAR AS WELL, NOW IT'S NOT THAT WE DIDN'T KNOW WE WERE GOING TO HAVE A TIGHT BUDGET, BUT FOR VARIOUS REASONS, BASICALLY THE SPREAD BETWEEN THOSE THREE THINGS, SOME HAD AS LITTLE AS A 4 1/2% CUT, OTHER PARTS HAD AS LARGE AS A 6.0% CUT SO IT'S A PRETTY TIGHT BAND, EVERYONE IS MORE OR LESS EVENLY AFFECTED, SO THAT'S THE WAY WE CHOSE TO DISTRIBUTE IT. THAT'S PRETTY SIMILAR TO THE WAY MOST INSTITUTES DID IT. SOME HAD SPECIFIC NEEDS OR THINGS THAT MADE THEIR SPREAD BETWEEN THOSE THREE POTS A LITTLE BIT MORE THAN OURS, BUT THAT'S WHAT WE ELECTED TO DO. SO IN TERMS OF OTHER CONGRESSIONAL KINDS OF THINGS, WE'VE BEEN INVOLVED, AS YOU CAN SEE, QUITE ACTIVE ON THE HILL WITH A NUMBER OF CONGRESSIONAL BRIEFINGS THAT VARIOUS MEMBERS OF STAFF HAVE BEEN QUITE INVOLVED IN AGAIN, OFTEN QUITE INTERESTING AND I THINK QUITE USEFUL IN TERMS OF EDUCATING THE CONGRESS AND CONGRESSIONAL STAFFS ABOUT ISSUES THAT ARE VERY IMPORTANT TO US. MANY OF THESE WENT ON BECAUSE OF OUR CLOSE PARTNERSHIPS WITH VARIOUS ORGANIZATIONS THAT ARE FRIENDS OF NICHD AND OTHERS THAT INVITED US TO PARTICIPATE IN -- THAT WE DO PARTNER WITH A NUMBER OF OTHER GROUPS TO IMPROVE HEALTH AND TO MOVE FORWARD OUR MUTUAL MISSION. A COUPLE OF BILLS TO MAKE YOU AWARE OF THAT HAVE BEEN PUT IN THE HOPPER, NOW AGAIN, HARD TO KNOW WHAT BILLS WILL ACTUALLY BECOME LAW, BUT TO BE AWARE OF. THIS WAS A BILL INTRODUCE BID SENATORS KIRK AND JOHNSON. YOU CAN SEE IT'S INTERESTING IN TERMS OF THE SPONSORS OF THIS. OBVIOUSLY BOTH SIDES OF THE AISLE. ALSO OF INTEREST BOTH SENATORS WHO HAVE HAD STROKES WHILE THEY WERE SERVING IN THE SENATE. AND HAVE COME BACK FROM THOSE STROKES TO CONTINUE TO SERVE IN THE SENATE. THEY HAVE AN OBVIOUS INTEREST IN REHABILITATION AND THEY HAVE INTRODUCED SOME THINGS THAT WOULD HAVE SOME IMPACT ON THE NATIONAL CENTER FOR MEDICAL REHABILITATION RESEARCH. WE'VE HAD CONVERSATIONS WITH THEIR STAFFS OVER THESE BILLS, WE WERE INVITED TO MEET WITH THE STAFF AS THEY WERE DRAFTING BILLS, ET CETERA, WHICH WE WERE VERY THANKFUL FOR HAVING THAT CHANCE TO DO IT. YOU'LL NOTICE THAT ALSO REQUIRES FEASIBILITY OF RECOMMENDING THE -- PART OF THE REASON WHY WE WANT TO HAVE A NICE LONG SEPTEMBER COUNCIL MEETING IS I WILL BE COMING TO YOU, THIS WAS DONE WELL BEFORE THIS HIT THE HOPPER, BUT COMING TO YOU WITH OUR THOUGHTS ABOUT HOW WE ARE GOING TO IMPLEMENT A NUMBER OF RECOMMENDATIONS FROM THAT BLUE RIBBON PANEL, SO REGARDLESS OF WHAT HAPPENS IN THIS LEGISLATION WERE MOVING FORWARD, WE WILL FIRST BE TALKING WITH STAFF ABOUT THOSE, GETTING THEIR INPUT. WE WILL BE TALKING ABOUT THE NCMRR, THEY DON'T MEET AGAIN BEFORE YOUR SEPTEMBER COUNCIL MEETING BUT WE'RE GETTING INPUT FROM ALL OF THOSE BEFORE WE TALK WITH YOU TO GET YOUR INPUT IN SEPTEMBER. THAT, OF COURSE, WILL BE OPEN SESSION, WE'VE BEEN MEETING WITH LOTS OF OTHER INTERESTED PARTIES ABOUT -- THEIR THOUGHTS ABOUT THE BLUE RIBBON PANEL'S RECOMMENDATIONS AND CLEARLY BY THE TIME WE MEET IN SEPTEMBER, WE'LL BE READY TO MOVE FORWARD. ANOTHER ONE WHICH IS QUITE INTERESTING, THE KIDS FIRST RESEARCH BILL HAS BEEN INTRODUCED, AMONG OTHER THINGS, BECAUSE THERE ARE OTHER PARTS TO IT BUT THE MAJOR THING WOULD BE TO TERMINATE THE CHECK-OFF THAT HAS BEEN FOR A NUMBER OF YEARS ON OUR FEDERAL INCOME TAX FORMS FOR THE PRESIDENTIAL ELECTION CAMPAIGN, IT WOULD DO AWAY WITH THAT. IT WOULD BASICALLY INSTEAD -- THE ISSUES ARE KIND OF LINKED IN THIS BILL, ESTABLISH AND AUTHORIZE FUNDING FOR -- THAT AUTHORIZE FUNDING FOR IS IMPORTANT, TO APPROPRIATE THE FUNDING WOULD BE EVEN MORE IMPORTANT AT THE END OF THE DAY, A 10-YEAR PEDIATRIC RESEARCH INITIATIVE FUND TO BE ADMINISTERED THROUGH THE NIH COMMON FUND. THE NIH COMMON FUND IS AN AABILITY OF THE NIH TO ESTABLISH -- WHEREBY THERE WAS THIS COLLECTIVE AMOUNT OF NIH MONEY, CALLED THE COMMON FUND, THAT CAN BE USED FOR VARIOUS KINDS OF PARTICULARLY NEW EXPERIMENTS IN SCIENCE, NEW PROGRAMS, THOSE KINDS OF THINGS, THAT CUT ACROSS THE INTEREST OF MANY INSTITUTES. IT CUTS ACROSS MANY INSTITUTES. SO WE'LL SEE WHAT HAPPENS WITH THIS. IT HAS BEEN INTRODUCED IN THE HOUSE, IT HAS BEEN IDENTIFIED AS A PRIORITY BY THE HOUSE MAJORITY LEADERSHIP. FOR INSTANCE, ON APRIL 2ND, NATIONAL AUTISM DAY, ERIC CANTER, WHO IS THE HOUSE MAJORITY LEADER, HAD THIS FEATURED ON HIS WEBSITE. THIS IS CLEARLY SOMETHING -- WE'LL SEE WHAT HAPPENS WITH IT BUT THERE'S A FAIR BIT OF ATTENTION IN THE HOUSE TO IT AT THIS POINT. SO DO YOU HAVE ANY QUESTIONS? THIS IS ONE OF OUR -- ONE OF THE FOLKS THAT'S PROFITED FROM OUR RESEARCH, MY NEW GRANDSON, I WILL STOP TO SEE IF YOU HAVE ANY QUESTIONS BESIDES THE ONES THAT HE ASKED ME. ABOUT "THE NEW YORK TIMES" OR ABOUT WHAT I'VE BEEN JUST TALKING ABOUT. QUESTIONS YOU HAVE ABOUT THE LAST FEW MONTHS AROUND THIS PLACE? >> ALAN, GIVEN THAT BUDGETARY CONSIDERATIONS ARE ON EVERYBODY'S MIND, I WONDER IF THERE'S GOING TO BE AN OPPORTUNITY FOR COUNCIL TO TAKE A HIGH LEVEL BLUE SKY VIEW ABOUT WHAT I WOULD CALL THE BUDGET VISION. WE ALREADY TALKED ABOUT THE SCIENTIFIC VISION, WE HAVE A ROAD MAP THERE, BUT I DON'T THINK WE REALLY KNOW A LOT ABOUT THE STRATEGIC PLANS FOR VERY, VERY HIGH LEVEL PARTITIONING OF THE NICHD BUDGET, AND THAT MIGHT BE HELPFUL IF TIMES GET EVEN ROUGHER AHEAD. WE DON'T KNOW. >> THANK YOU VERY MUCH. I'LL GIVE YOU THE PIEF DOLLARS LATER FOR ASKING THE QUESTION BECAUSE, IN FACT, WE'VE BEEN AWARE THAT WE OWE IT TO COUNCIL TO GIVE YOU A KIND OF FIRST OF ALL NICHD BUDGET 101 KIND OF THING, WHICH YOU WILL BE GETTING SOON. AND THE REASON FOR DOING THAT IS NOT JUST TO SATISFY CURIOSITY YOU MIGHT HAVE, BUT TO HELP US IN MAKING THESE KINDS OF DECISIONS AS WE MOVE FORWARD, SO ABSOLUTELY, THAT'S ONE OF THE THINGS WE'D LIKE TO DB WE CLEARLY, TO BE HONEST AND STRAIGHTFORWARD ABOUT THIS, WE THINK IT WOULD BE A MISTAKE FOR NICHD -- I KNOW YOU'RE NOT SUGGESTING THIS -- TO HAVE COUNCIL TELL US EXACTLY HOW MANY PENCILS WE SHOULD BE ORDERING. ON THE OTHER HAND, TO HAVE THE INPUT FROM COUNCIL ABOUT SOME OF THESE LARGER DECISIONS, THIS QUESTION OF TO WHAT DEGREE AT A TIME LIKE THIS SHOULD ONE BE THINKING ABOUT FUNDING RISKY SCIENCE, TO WHAT DEGREE AT THIS POINT SHOULD ONE BE THINKING ABOUT NOVEL VERSUS SUPPORTING NETWORKS WE SUPPORTED FOR MANY YEARS THAT CONTINUE TO BE PRODUCTIVE, ET CETERA. THOSE KINDS OF DECISIONS WILL BE IMPORTANT. WHAT'S HAPPENING, OF COURSE, JUST TO REMIND FOLKS, IS THAT STAFF IS REALLY DOING THE JOB OF LOOKING INFORMED BY THE VISIONING PROCESS, ONLY INFORMED BY NOT DICTATED, LOOKING AT EVERYTHING WE DO BASICALLY AND SAYING WHAT DO WE THINK ARE SOME NEW INITIATIVES AND KINDS OF THINGS WE SHOULD BE DOING. SO WE REALLY COULD USE COUNCIL'S ADVICE, NOT ON ADMINISTRATIVE MANAGEMENT BUT ON THE SCIENCE OF THIS. BASED UPON THE SCIENCE, HOW SHOULD WE BE THINKING ABOUT SUPPORTING AND CATALYZING SCIENCE IN THE CURRENT WORLD OF THIS KIND OF THING, FOR INSTANCE, THE QUESTIONS, HOW MUCH OF THE -- SHOULD BE ABOUT TRAINING VERSUS FUNDING THE SCIENCE THAT THOSE FOLKS THAT WE HAVE TRAINED OVER THE YEARS ARE NOW DOING. THOSE KINDS OF QUESTIONS, WE CLEARLY COULD USE YOUR INPUT ABOUT, NO QUESTION. GORDON. >> I HAVE JUST A COMMENT ABOUT -- THAT RELATES TO THIS ISSUE OF TRAINING, AND IT REALLY HAS COME ABOUT -- THIS IS REALLY MORE IN CONSTANTINE'S BUT SOME OF THE PEOPLE HA I KNOW IN THE INTRAMURAL PROGRAM LET ME KNOW I WON'T BE SEEING THEM AT THE ANNUAL SOCIETY MEETING BECAUSE OF THE BUDGETARY RESTRICTIONS, AND JUST FOR MY OWN PERSPECTIVE, I'VE WORKED HERE AND AT OTHER PLACES, THE NIH ACTUALLY SPENDS, FOR ITS TENURED STAFF, LESS ON TRAINING, OUTSIDE ACTIVITY, THIS SORT OF THING, CERTAINLY -- WHAT HAPPENED IN INDUSTRY, WHERE THEY REALIZE THEIR EMPLOYEES ARE SO VALUABLE THAT HAVING THEM BE ABLE TO WORK AT THEIR FULL POTENTIAL, KNOW WHAT THEY'RE DOING AND SO ON, IS PROBABLY -- THEY PROBABLY SPEND 2 TO 5% OF THE YEAR AS FULLY NOTHING BUT IMPROVING THEIR CAPABILITIES AND TRAINING, AND I WORRY THAT IF WE DON'T LET A TENURED MEMBER GO TO ONE MEETING A YEAR IN THE KEY AREA THAT THEY'RE WORKING, THAT IN ORDER TO SAVE PROBABLY LESS THAN 1% OF THEIR SALARY, WE'RE COMPROMISING THEIR ABILITY TO DO THE BEST SCIENCE. I REALIZE THAT WE GET INFORMATION FROM SOME SOURCES, BUT AT LEAST ONE MEETING A YEAR, I THINK -- >> WHATEVER GAVE YOU THE IMPRESSION THAT THEY WEREN'T ALLOWED TO GO TO ONE MEETING A YEAR WAS COMPLETELY WRONG, SO LET ME FIRST REASSURE YOU ABOUT THAT. HOWEVER, YOU'VE RAISED AN IMPORTANT ISSUE, WHICH IS CLEARLY FOLKS ARE ALLOWED TO GO TO MEETINGS. HOWEVER, REMEMBER THIS 5.68% BUDGET REDUCTION, REMEMBER THE INTRAMURAL PROGRAM PARTWAY THROUGH THE YEAR NEEDED TO REDUCE THEIR BUDGET BY 4 1/2%. THE REST OF THE PROGRAM, WE REDUCED RMS BY 4 1/2%. SO IF WE'RE NOT GOING TO REDUCE SALARIES, WE'RE NOT GOING TO FURLOUGH PEOPLE, IF WE'RE NOT GOING TO CUT EVEN FURTHER THAN WE HAD TO IN THE SUPPLIES, ET CETERA, ET CETERA, THE PEOPLE THAT USE THE INTRAMURAL PROGRAM, THERE ARE OTHER PLACES YOU CAN CUT AND ONE OF THEM IS, IN FACT, ATTENDING MEETINGS. SO WE HAVE -- AND THIS IS ONE OF THESE THINGS LEFT UP TO EACH INSTITUTE, POLICIES HAVE VARIED SOMEWHAT ACROSS INSTITUTES, BUT ALL PARTS OF THE NIH, I CAN TELL YOU DR. COLLINS DOESN'T LEAVE HIS OFFICE ANYMORE. THAT'S A LITTLE BIT OVERDOING IT BUT ALMOST THE CASE. SO THAT -- AND THOSE OF US IN LEADERSHIP, I HAD TO CANCEL A NUMBER OF MEETINGS WHERE I WAS A, YOU KNOW, KEYNOTE SPEAKER, ET CETERA, SO WE'VE ALL HAD TO DO HA. IS THIS GOOD FOR SCIENCE? I DON'T THINK SO. IS IT SOMETHING THAT'S NECESSARY AT LEAST FOR THIS YEAR? UNFORTUNATELY, IT IS. WE ARE VERY MUCH HOPING THAT IN FISCAL YEAR '14, WE WILL BE ABLE TO RETURN FOR WHAT IS FOR US A MORE NORMAL KIND OF THING FOR TWO IMPORTANT REASON, I THINK. ONE IS CLEARLY THE VALUE WHICH YOU JUST TALKED ABOUT, AND WE ALL KNOW THE VALUE TO THE SCIENTISTS OF BEING ABLE TO DO THOSE KINDS OF THINGS. BUT I THINK IT'S ALSO THE VALUE TO PROTECTING -- I CAN TELL YOU, AS A CUSTODIAN OF NICHD, WHICH IS REALLY WHAT I CONSIDER MYSELF, CLEARLY WHAT I SEE MY ROLE, I KNOW YVONNE, KATHY, CONSTANTINE, OTHERS, PART OF WHAT WE'RE DOING IS WE'RE PROTECTING THE BRAND. WE WERE GIVEN THIS INSTITUTE TO HAVE LEADERSHIP POSITIONS, WHICH IS SEEN AS SUCH A LEADING FORCE ACROSS THIS VERY BROAD MISSION THAT IS OURS. THE WORST THING WE COULD DO WOULD BE THE END OF OUR TENURES, WHENEVER THAT IS, TURN OVER SOMETHING THAT'S NO LONGER A FLAGSHIP ENTERPRISE. THAT'S THE OTHER VALUE OF OUR GOING PLACES, IS THAT WE GET TO BE IMPORTANT PLAYERS IN A LOT OF THINGS THAT ARE HAPPENING, PEOPLE SEE THE VALUE THAT WE BRING TO IT, ET CETERA, SO IT'S A TWO-WAY DYNAMIC, AND BOTH PARTS OF THAT, WE'RE KEENLY AWARE, SURF WHE SUFFER WHEN WE HAVE TO LIMIT CONFERENCES AND THOSE OTHER KINDS OF THINGS. SO THE POINT IS WELL TAKEN. WE UNFORTUNATELY ARE WHERE WE ARE. THIS IS PART OF THE IMPACT OF THE SEQUESTER, TO BE COMPLETELY HONEST. I APPRECIATE YOUR BRINGING UP THE POINT. >> I ALSO YOU SHOULD SAY, I MAY BE MISINFORMED, I WASN'T ACTUALLY TOLD THEY COULDN'T GO TO ONE BUT I KNOW THAT THEY'RE CHOOSING NOT TO GO TO, AND FOR SOME OF THESE, THEY MAY HAVE CHOSEN A PEDIATRIC ENDOCRINE MEETING. IN THE PAST, I KNOW THAT THERE WERE -- YOU MIGHT GIVE A FLAT A $500 AND THEN YOU WERE AT RISK FOR ANYTHING OVER THAT. SO I THINK THERE WERE ALTERNATIVES WHERE YOU COULD STILL ENCOURAGE THE -- TO GO TO THE -- >> I WON'T BORE YOU WITH ALL OF THE DETAILS, BUT WE'RE HAPPY TO MAKE THEM KNOWN TO YOU, OF THE TIERED APPROACH WE'VE TAKEN AT NICHD IN TERMS OF WHERE IN THE ESTABLISHMENT YOU ARE, ROUGHLY, IT'S BEEN CORRELATED WITH YOUR STATUS. THE HIGHER YOUR STATUS, THE LESS YOU'RE ALLOWED TO TRAVEL, ESSENTIALLY, SO THAT IF YOU ARE A TRAINEE, FOR INSTANCE, WE WANT YOU AT CONFERENCES, IT'S IMPORTANT BOTH TO -- AND EVENTUALLY GETTING A JOB. IF YOU'RE HIGHER IN THE HIERARCHY, BASICALLY YOU HAVE TO BE PLAYING A VERY ACTIVE ROLE AT THAT MEETING, YOU HAVE TO HAVE A PLATFORM PRESENTATION, YOU HAVE TO BE CHAIRING A SESSION OR SOMETHING LIKE THAT. BUT WE WOULDN'T DEMAND THAT FOR TRFORTRAINEES, SO TO SOME DEGREE IT DEPENDS ON THE STATUS IN YOUR ORGANIZATION. ON A CASE BY CASE SORT OF METHOD. NOW I SHOULD SAY THERE WAS A COUPLE MONTH PERIOD WHEN WE DIDN'T KNOW WHAT THE SIZE OF THE CUT WAS GOING TO BE, JUST A HUGE CUT WAS LOOMING, BACK IN MARCH, APRIL, MAY, WE WERE EVEN BEING MORE DRACONIAN BECAUSE WE THOUGHT WE MIGHT END UP WITH A LARGER CUT. SO WE WERE ABLE TO LOOSEN THINGS A LITTLE BIT. >> THIS IS MY SCOTTISH BACKGROUND AND I'LL PROBABLY RUIN MY REPUTATION BY SUGGESTING THIS, BUT IT DRIVES ME CRAZY WHEN I GET THE FEDEX MAILINGS FROM YOU ALL AND THIS HAS BEEN A THING FOR FOUR YEARS, NOTHING THAT WE GET COULDN'T BE SENT A WEEK EARLIER THROUGH THE REGULAR MAIL AND THEY NEED THE BUSINESS. THE OTHER THING IS, I ALWAYS GET SENT -- I GUESS I SHOULD HAVE COMPLAINED, A PARKING PERMIT, WHICH IS VERY NICE BUT I LEAVE MY CAR AT THE HOTEL SO I DON'T ACTUALLY USE IT. SO THEN IT'S $20 PLUS THE TIME, THEY COULD HAVE SENT ME AN EMAIL DO YOU WANT A PARKING PERMIT. ALSO I THINK THE CONFLICT OF INTEREST STUFF REALLY COULD BE DONE THROUGH THE MAIL. IT DOESN'T REALLY NEED A SIGNATURE ON IT -- I MEAN THROUGH EMAIL. WE DON'T REALLY NEED A FEDEX MAIN MAILING ON ALL THOSE THINGS. SO I ACTUALLY TRIED TO IMAGINE IF EVERY INSTITUTE IS DOING THIS, YOU COULD PROBABLY SUPPORT A SMALL GRANT ON THE FEDEX BUDGET. >> I THINK SOME OF THAT IS VERY WELL TAKEN, AND WE WILL TAKE THAT UNDER ADVISEMENT. PEOPLE HAVE LOOKED AT A LOT OF THESE THINGS. SOME OF THE FEDEX SPECIFICALLY, BECAUSE I'VE INQUIRED ABOUT THIS FOR A NUMBER OF YEARS, AT VARIOUS INSTITUTES, IT TURNS OUT FOR SOME OF THE FEDEX, THE CONTRACT WITH FEDEX IS SUCH THAT IT'S ACTUALLY CHEAPER THAN WHAT WE THINK OF AS CHEAPER WAYS OF COMMUNICATING WITH PEOPLE. IT'S STILL TRUE -- AND THERE'S SOME THINGS WHICH I WOULD SAY DON'T MAKE SENSE BUT VARIOUS REGULATIONS, ET CETERA, DEMAND WE DO IT A CERTAIN WAY. THAT SAID, THERE ARE OTHER THINGS THAT WE ASSUME ARE REGULATIONS, THERE'S SOME SORT OF SUPREME COURT DECISION THAT MEANS WE HAVE TO GET YOUR SIGNATURE ON SOMETHING, AND, IN FACT, IT'S SELF-IMPOSED. SO WE WILL CONTINUE TO LOOK AT WAYS THAT WE CAN CUT THOSE, AND THERE HAVE BEEN A NUMBER OF THINGS WHERE -- IT'S QUITE OWE FIBL. OFFICIAL. >> BUT YOU CAN SEND A REGULAR SIGNATURE THROUGH THE U.S. POST OFFICE. YOU JUST HAVE TO SEND IT OUT A WEEK EARLIER. >> WHETHER OR NOT IT ACTUALLY ENDS UP BEING CHEAPER -- ANY OTHER QUESTIONS OR THOUGHTS ABOUT THAT? >> I WAS VERY ENCOURAGED BY THE PEDIATRIC RESEARCH INITIATIVE FUND THAT YOU TALKED ABOUT. DO YOU HAVE ANY MORE INFORMATION ABOUT HOW PRIORITIES ARE GOING TO BE STATED AND WHAT'S GOING TO BE NICHD'S UNIQUE ROLE IN SETTING THOSE PRIORITIES? >> WELL, TO MAKE IT CLEAR, THIS IS JUST A BILL THAT'S BEEN INTRODUCED IN THE HOUSE. IT WOULD HAVE TO PASS THE HOUSE. IT WOULD HAVE TO PASS THE SENATE. IF IT HAD A DIFFERENT FORM IN THE HOUSE AND SENATE, HAS TO BE CONFERENCED, HAS TO BE PASSED BY BOTH, IT WOULD THEN HAVE TO GO TO THE PRESIDENT, THE PRESIDENT WOULD THEN HAVE TO SIGN IT, THEN THE CONGRESS WOULD ACTUALLY HAVE TO AUTHORIZE OR APPROPRIATE THE MONEY TO DO IT. SO THERE ARE QUITE A NUMBER OF STEPS HERE. SO IF IT WERE TO HAPPEN, I THINK WITH ALL THE OTHER -- YOU CAN IMAGINE THE NUMBER OF BILLS THAT HAVE BEEN INTRODUCED IN THE CONGRESS. USUALLY NIH DOESN'T VERY ACTIVELY PLAN HOW TO MANAGE ANY OF THEM UNTIL THEY COME CLOSER TO SEEING THE LIGHT OF DAY. SO THERE HAVE BEEN NO ACTIVE DISCUSSIONS AT NIH EXACTLY HOW THIS WOULD HAPPEN. I WOULD ASSUME, AND WOULD FIGHT HARD FOR THE FACT THAT NICHD SHOULD TAKE A LEADING ROLE IN THIS. HOWEVER, CLEARLY, THI IF THIS WAS A COMMON FUND INITIATIVE, IT WOULD BE SOMETHING DLIBLY SAID TO BE OF INTEREST TO MANY ICs, SO I'M SURE THAT WOULD BE THE CASE. AND I SHOULD ALSO STRESS THERE IS NO OFFICIAL -- WE DON'T HAVE A POSITION ON THIS BILL THIS IS JUST A BILL THAT'S BEEN INTRODUCED LIKE MANY THAT HAVE BEEN INTRODUCED, SOMETIMES THERE IS A DECISION, THE EXECUTIVE BRANCH OF WHICH WE'RE A PART, TAKES AN OFFICIAL POSITION, THIS IS ONE AGAIN THAT'S SO PRELIMINARY, WE'RE NEITHER FOR NOR AGAINST THIS. I'M JUST BRINGING IT TO YOUR ATTENTION BECAUSE I THOUGHT YOU'D FIND IT OF INTEREST. >> NEXT, KATHY SPONGE IS YOU UP. AND THIS GETS TO -- THIS IS PART OF THE ANSWER TO DIANA'S VERY GOOD QUESTION. >> THANK YOU SO MUCH. THANKS FOR THE OPPORTUNITY TO GIVE A BRIEF UPDATE ON THE DIVISION OF EXTRAMURAL RESEARCH OF NICHD. AS WAS SO APTLY BROUGHT UP THIS MORNING, WE'RE GOING TO GIVE YOU A LITTLE BIT ABOUT THE BUDGET AND HOW THE BUDGET IS FORMED AND SO I'M GOING TO BE BRIEF ON THE DER UPDATE. THE TOPICS I WAS HOPING TO COVER TODAY BRIEFLY ARE THE NICHD VISION WHERE WE STAND IN THAT PROCESS. GIVE YOU SOME INFORMATION ON THE SENIOR STAFF, THE BRANCH CHIEF POSITIONS THAT ARE OPEN AND BEING ACTIVELY COMPETED. I'M GOING TO TALK A LITTLE BIT ABOUT CONFLICT OF INTEREST AND HOW WE'VE WORKED ON THAT PIECE FOR THE DIVISION OF EXTRAMURAL RESEARCH, A LITTLE BIT ABOUT FINANCIAL REALITIES. ALAN'S TALKED MOSTLY ABOUT THAT SO I DON'T HAVE TO DO THE HEAVY HAND THERE. UPDATE ON THE NIH COLLABORATION WITH THE CLINICAL CENTER, THEN ALEXIS WILL CONTINUE WITH THE BUDGET PRESENTATION. AS MOST OF YOU LIKELY KNOW, THE SCIENTIFIC VISION WAS FORMED OVER THE LAST SEVERAL YEARS WITH MANY, MANY OF YOU AND OUR CONSTITUENTS HELPING TO FORM THIS VISION. AND NOW IT IS TIME FOR US TO IMPLEMENT THE NICHD PORTION OF THAT VISION, BECAUSE THAT VISION, AGAIN, WAS MADE FOR THE FIELD. SO AS WE MOVE FORWARD AND TRY TO IDENTIFY WHAT IS IT THAT IS UNIQUE TO THE NICHD MISSION, WHAT REQUIRES NICHD TO TAKE THE LEAD OR IT WON'T GET DONE. WHAT ARE THOSE AREAS THAT ARE RESULT-ORIENTED AND ARE SPECIFIC TO HELP US FILL CRITICAL KNOWLEDGE GAPS AND PROVIDE THE FOUNDATION TO CHANGE CLINICAL AND PUBLIC HEALTH PRACTICE, AND WHAT ARE THOSE ASPECTS AT NICHD CAN TAKE ON THAT ARE ACTIONABLE, IN THE SHORT TERM AS WELL AS THE LONGER TERM, USING EXISTING OR CREATIVELY GENERATING OR ACCESSING ADDITIONAL RESOURCES. AS I BRIEFLY MENTIONED AT OUR LAST MEETING, WHAT WE HAVE DONE ONCE THE VISION HAD BEEN PULLED TOGETHER WITH NICHD STAFF WAS INVITED TO NOMINATE IDEAS BASED ON THE WHITE PAPERS, VISION WORKSHOPS AND VISION STATEMENT, AND THOSE IDEAS WERE COLLATED AND SURVEYED FOR STAFF INPUT AS TO HOW CRITICAL WERE THEY FOR NICHD TO TAKE ON, MEANING THAT MANY OF THESE IDEAS ARE VERY, VERY IMPORTANT AND THE FIELD NEEDS TO MOVE THEM FORWARD BUT IT MAY NOT REQUIRE NICHD TO TAKE THE LEAD. SO IT'S NOT SAYING THE IDEAS AREN'T IMPORTANT, BUT WHAT DOES NICHD NEED TO DO TO MOVE FORWARD. WE HELD A TOWN HALL MEETING ON JANUARY 29TH AT LISTER HILL TALKING ABOUT A NUMBER OF THESE TOPICS, AND BASED ON THAT DISCUSSION, WE THEN CREATED THESE VISIONOGRAMS TO LOOK AT THE POTENTIAL OF THESE AREAS, HOW DIFFICULT WOULD THEY BE TO ACCOMPLISH. HOW LONG WOULD IT TAKE TO COMPLETE THEM? WHAT IS THE LIKELIHOOD OF SUCCESS? WHAT MECHANISMS WOULD BE BEST UTILIZED TO IMPLEMENT THEM, AND WHO WOULD BE POTENTIAL PARTNERS? BASED ON THESE VISIONOGRAMS, WE WILL IDENTIFY THE INITIAL AREAS FOR THE NICHD VISION FOCUS, AND WE'D HOPE TO BRING THOSE TO YOU AT OUR NEXT COUNCIL MEETING, ANOTHER REASON WHY THAT SEPTEMBER COUNCIL MIGHT NOT BE A BAD IDEA TO HAVE IT AS A DAY AND A HALF. AND THE IMPLEMENTATION THEN WILL DEPEND ON FUNDING AVAILABILITY. AND THE MECHANISMS OF HOW WE CAN IMPLEMENT THESE DIFFERENT IDEAS. WE HAVE ADVERTISED FOR SENIOR STAFF OPENINGS, WE HAVE FOUR OPEN BRANCH CHIEF POSITIONS, TWO OF THESE ARE FOR THE NEW BRANCHES, THE GYNECOLOGIC HEALTH AND DISEASE BRANCH AND THE PEDIATRIC TRAUMA AND CRITICAL ILLNESS BRANCH, AND THEN TWO ARE FOUR OPEN BRANCH CHIEF POSITIONS. THE INTERVIEWS ARE ONGOING AND IT IS MY HOPE THAT AT THE SEPTEMBER COUNCIL, I'LL BE ABLE TO ANNOUNCE THE FULFILLMENT OF MANY OF THESE POSITIONS. WE REVIEWED THE CURRENT NICHD CONFLICT OF INTEREST POLICIES ACROSS NICHD, ACROSS ALL KINDS OF MECHANISMS, A HUGE TEAM CAME TOGETHER LOOKING AT THIS, AND WE BOLSTERED OUR STAFF CONFLICT OF INTEREST POLICIES, LOOKING AT OUTSIDE ACTIVITIES AND OFFICIAL DUTIES THAT MANY OF OUR STAFF HOLD, AND UPDATED OUR SYSTEMS TO REFLECT THESE CONFLICTS OF INTEREST. YOU WILL SEE THAT THIS AFTERNOON IN THE CLOSED SESSION, IN THE COUNCIL ACTIONS, AND AS WELL AS HAS BEEN THE CASE FOR MANY YEARS BUT HAS BEEN MORE FORMALIZED NOW IN PROGRAM MANAGEMENT, MAKING CERTAIN THAT NO STAFF MEMBER WHO HAS A CONFLICT OF INTEREST IS INVOLVED IN THAT ACTIVITY. AS ALAN MENTIONED, SEQUESTRATION CLEARLY HAS HAD AN IMPACT AND AS DR. CUTLER COMMENTED ON, TRAVEL IS ONE OF THOSE AREAS, AS WELL AS FUNDING AND ATTENDANCE AT MEETINGS. THIS NOT ONLY IS DUE TO THE FINANCIAL REALITIES OF THE SEQUESTRATION BUT IS ALSO DUE TO THE PERCEPTION. WHEN WE TRAVEL PLACES, IT'S CLEAR THAT WE ARE TRAVELING THERE AT THE BEHEST OF THE GOVERNMENT AND WORKING AND REPRESENTING THE GOVERNMENT, WHICH IS WONDERFUL, BUT WHEN THERE ARE OTHER GOVERNMENT ENTITIES THAT ARE FURLOUGHING PEOPLE, AND WE ARE TRAVELING AND PARTICIPATING AT A CONFERENCE, IT DOES TEND TO RAISE SOME QUESTIONS, AND SO IT'S NOT ONLY THE COST BUT ALSO THE PERCEPTION. THERE HAS BEEN A NEW LAW THAT HAS PASSED ON CONFERENCES, AND THIS NEW LAW HAS REQUIRED MANY CHANGES AND HAS RESULTED IN THE CANCELLATION OF SOME MEETINGS, AND LIMITED WHAT WE CAN PROVIDE AND WHAT IS COVERED. IT IS ALSO REQUIRED A NUMBER OF ADDITIONAL CLEARANCES AND REPORTING REQUIREMENTS. FOR ANY CONFERENCES THAT WE ARE PLANNING TO ATTEND, FOR ANY WORKSHOPS THAT WE ARE PLANNING TO HOLD, THERE'S A NUMBER OF STEPS NOW THAT WE NEED TO GO THROUGH, AND THESE NEW LAW ON CONFERENCES AT THE MOMENT HAS BROADENED THE DEFINITION OF CONFERENCE TO INCLUDE THINGS SUCH AS PEER REVIEW AND COUNCIL, SO IT HAS MADE IT EVEN A LITTLE MORE DIFFICULT JUST TO DO THE DAILY JOB THAT WE ARE TRYING TO DO. ON A POSITIVE NOTE, THE COLLABORATIONS WITH THE CLINICAL CENTER PROGRAM, OPPORTUNITIES FOR COLLABORATIVE RESEARCH AT THE NIH CLINICAL CENTER, THE WAY TO OPEN THE CLINICAL CENTER TO BE EXTRAMURAL COMMUNITY HAS BEEN INCREDIBLY SUCCESSFUL. GENE AND CONSTANTINE HAVE DONE A GREAT JOB IN LEADING THIS EFFORT. CONSTANTINE IS THE CHAIR OF THE GROUP AND GENE HAS BEEN ACTIVE IN HELPING TO FIGURE OUT HOW TO GET IT ALL DONE. THE APPLICATIONS ARE CURRENTLY UNDER REVIEW AND AWARD IS ANTICIPATED IN EARLY FY2014, AND WE DO ANTICIPATE THAT THIS PROGRAM WILL CONTINUE WITH ADDITIONAL RECEIPT DATES IN FUTURE YEARS. SO RDER GOALS IMMEDIATELY ARE TO IDENTIFY THESE TOPICS TO IMPLEMENT THE NICHD VISION, TO FILL THE SENIOR POSITIONS, AND AS BEST WE CAN, TO OPTIMIZE OUR OPPORTUNITIES IN THESE TIGHT FISCAL TIMES. TO GIVE US INFORMATION ABOUT THESE TIGHT FISCAL TIMES, I'D LIKE TO INTRODUCE MISS ALEXIS CLARK, CHIEF OF THE FINANCIAL MANAGEMENT BRANCH. SHE'S GOING TO GIVE YOU INFORMATION ON THE NICHD BUDGET AND HOW WE FORMULATE THAT BUDGET. ALEXIS. >> GOOD MORNING, EVERYBODY. AS KATHY SAID, I'M ALEXIST CLARK, ALSO KNOWN AS THE BUDGET OFFICER. IF YOU HEAR THAT TERM, THAT'S ME TOO. I'M GOING TO TRY AND GO THROUGH QUICKLY HERE SOME OF THE KEY POINTS ABOUT FORMULATION, PUTTING THE BUDGET TOGETHER AND HOW WE'RE IMPLEMENTING THE FY '13 BUDGET. SO I'M GOING TO TALK A LITTLE BIT ABOUT THE CONGRESSIONAL APPROPRIATIONS PROCESS, I'M GOING TO GIVE YOU A LITTLE BIT OF A GLANCE AT WHAT THE NICHD BUDGET LOOKS LIKE, TALK ABOUT SOME OF THE PROGRAMS WE'RE MANDATED TO DO, LOOK AT HOW WE DEVELOP A BUDGET, SOME OF THE FACTORS THAT SEEM TO CONSTANTLY BE CHANGING, THE PROCESS FOR PUTTING IT TOGETHER. A QUICK SNAPSHOT OF RMS AND INTRAMURAL BUDGET. I'LL TOUCH ON SEQUESTRATION AS THAT'S AN OVERRIDING THEME, AND FINALLY WHAT WE DO IN DEVELOPING THE GRANT BUDGET AND RPG PAYLINES. SO CONGRESSIONAL APPROPRIATIONS. THEY DO HAVE IN THEORY A STANDARD TIMELINE. AGENCIES BEGIN DEVELOPING THEIR BUDGET REQUESTS OVER A YEAR IN ADVANCE OF THE START OF THE FISCAL YEAR. WE'RE CURRENTLY DOING WORK ON THE FY15 PRESIDENT'S BUDGET. THE CONGRESSIONAL JUSTIFICATION IS TRADITIONALLY SENT TO CONGRESS ON THE FIRST MONDAY IN FEBRUARY, AS DR. GUTTMACHER SAID, IT DOESN'T ALWAYS MAKE IT. THEN WE'VE HAD DELAYS DUE TO PRESIDENTIAL -- CONGRESS TRADITIONALLY HOLDS APPROPRIATION HEARINGS IN THE SPRING, AND COMMITTEES WORK IN THE SUMMER WITH THE GOAL TO APPROPRIATE FUNDS BY OCTOBER OCTOBER 1ST. YOU MAY BE FAMILY THAT THAT GOAL IS OFTEN UNFULFILLED, AND IN THAT CASE, WE HAVE CONTINUING RESOLUTIONS OR CRs. WE HAVE HAD ONE EVERY YEAR SINCE 1997. CRs PROVIDE PARTIAL FUNDING BASED ON PREVIOUS YEAR' SPENDING RATES, SO IT'S JUST THE WAY TO KEEP US GOING WHILE CONGRESS TRIES TO FINISH THEIR WORK. SO HERE IS A QUICK LOOK AT OUR NICHD BUDGET. THIS IS LAST YEAR'S BUDGET. BY MECHANISM. LAST YEAR WE HAD $1.32 BILLION. THE LARGEST CHUNK OF THE BUDGET IS THE RPGs. INTRAMURAL% IS ABOUT 14% AND RMS IS ABOUT 5%. THEN R & D CONTRACTS IS ABOUT 10% OF OUR BUDGET. THERE ARE SOME AREAS WHERE NICHD IS MANDATED TO SPEND CERTAIN AMOUNTS, ALL MECHANISMS INCLUDING OPERATING COSTS. THE FIRST AREA IS AIDS FUNDING. IN FY13, WE HAVE TO SPEND AT LEAST $136.5 MILLION ON AIDS RESEARCH. THE OFFICE OF AIDS RESEARCH COORDINATES THE AIDS RESEARCH AND BUDGET ACROSS NIH AND ALLOCATES AIDS FUNDS TO THE ICs ANNUALLY. THE SECOND AREA IS FBIR/FTTR FUNDING. WE HAVE TO SPEND $30.5 MILLION ON THOSE TYPES OF GRANTS THIS YEAR. THIS PROGRAM WAS RE-AUTHORIZED IN DECEMBER OF 2011, AND IT MANDATES THAT A PERCENTAGE OF EXTRAMURAL FUNDING BE SET ASIDE FOR EACH CATEGORY, WITH THE TOTAL PERCENTAGE INCREASING EACH YEAR AND THROUGH 2017. THIS YEAR, SBIR HAS TO BE 2.7% OF THE EXTRAMURAL BUDGET AND STTR IS .35%. SO WHEN WE'RE LOOKING AT PUTTING TOGETHER A BUDGET, WE HAVE SEVERAL FACTORS WE TRY TO TAKE INTO ACCOUNT, BUT THINGS WHICH ARE OFTEN CHANGING AND DIFFICULT TO PIN DOWN. THE FIRST ONE IS WHAT WE CALL OUR CAPS AND ASSESSMENTS. THESE ARE COSTS THAT WE HAVE TO PAY ACROSS MANY MECHANISMS THAT COME FROM WITHIN NIH AND FROM THE DEPARTMENT FOR SORT OF CENTRALIZED THINGS. WE TRY TO FIND SAVINGS WHERE WE CAN, WE TRY TO TAKE INTO ACCOUNT UNEXPECTED NEEDS WHICH HAVE COME UP SINCE WE ORIGINALLY PUT TOGETHER THE PLAN FOR THE BUDGET, WE TRY TO TAKE INTO ACCOUNT THE OER POLICY AND NONCOMPETING COMMITMENTS ONCE THEY'VE ANNOUNCED IT, AND WE ALSO LOOK AT WHETHER THERE'S ANY NEW LEGISLATIVE OR POLICY MANDATES THAT WE NEED TO ACCOMMODATE. SO WE PUT TOGETHER OUR ESTIMATE FOR ALL OF THE TAPS AND ASSESSMENTS AND MAKE ALL THE KNOWN ADJUSTMENTS TO OUR BUDGET PLAN. IN TERMS OF THE RS R & D BUDGET, WE GENERATE A LIST OF ALL OF OUR CONTRACT BUDGETS BY REVIEWING THE LIST OF APPROVED RFPs, REQUEST FOR PROPOSALS. WE GENERATE A FULL LIST OF ALL THE ONGOING AND NEW PROJECTS FOR THE YEAR. WE MEET WITH EACH BRANCH AT OFFICE EVERY YEAR TO GO THROUGH WHAT CONTRACTS THEY ARE PLANNING TO HAVE IN THE YEAR, AND THEN WE REVIEW THE FULL LIST OF PROJECTS WITH SENIOR LEADERSHIP TO MAKE SURE WE'RE ALL IN AGREEMENT ABOUT HOW THE CONTRACT BUDGET WILL MOVE FORWARD FOR THE YEAR. AND WE ALSO WORK ON DEVELOPING ESTIMATES FOR THE RMS AND THE INTRAMURAL NEEDS WITH THE HELP OF THE FOLKS IN DIR, I >> YOU CAN CERTAINLY CONTACT ME. THANK YOU. >> TO KIND OF GET THE BACKGROUND STRAIGHT, HAVE ANY OF THE INSTITUTES ELECTED TO PRESERVE THE EXTRAMURAL PROGRAM I AND CLOSE INTRAMURAL LABORATORIES? THAT'S A FAIR RESPONSE. >> WE TALKED ABOUT SOME BEFORE, WE CAN HAVE A LARGER DISCUSSION ON THE POINT BUT WE REALLY BELIEVE THAT THERE ARE SOME THINGS THAT ARE BEST DONE BY THE EXTRAMURAL PROGRAM. WE BELIEVE THERE ARE OTHERS THAT ARE REALLY BEST DONE BY THE INTRAMURAL PROGRAM. AND TO MOVE FORWARD OUR MISSION AREA, TO HAVE BOTH, REALLY, IS OPTIMAL. AND THAT'S OBVIOUSLY A DECISION THAT'S BEEN MADE BY THE VAST MAJORITY, ALMOST EVERY INSTITUTE AT NIH HAVE BOTH PROGRAMS. SO FAIR QUESTION. WE HAVE TIME FOR ONE MORE QUESTION, THEN I KNOW OUR NEXT SPEAKER IS ON A TIGHT TIME FRAME AND WE'RE RUNNING LATE, SO RENE, YOU GET THE LAST QUESTION. >> YOU MENTIONED SOMETHING ABOUT NEW LAWS GOVERNING CONFERENCES, AND I WASN'T SURE WHAT CONTEXT THAT WAS IN FOR FEDERAL EMPLOYEES OR FOR PEOPLE LIKE US EXTERNALLY. I KNOW THERE'S A LOT OF NEWS ABOUT VARIOUS CONFERENCE EXPENDITURES, AND I DIDN'T KNOW -- >> SO IT ACTUALLY IMPACTS BOTH. IT IMPACTS THE CONFERENCES AND WORKSHOPS THAT STAFF ARE GOING TO, AS WELL AS CONFERENCES AND WORKSHOPS THAT WE MAY BE HOLDING THAT WE MAY BE BRINGING PEOPLE TO, AND RIGHT NOW IT EVEN INCLUDES PEER REVIEW MEETINGS, AND AS YOU HAVE SEEN OVER TIME, PERHAPS, WHAT WE CAN OFFER, COFFEE, THOSE KINDS OF THINGS HAVE ALL GONE AWAY. SO THERE'S A NUMBER OF THINGS THAT HAVE GONE INTO PLACE AS WELL AS ENHANCED REPORTING REQUIREMENTS WHERE WE NEED TO TELL AND GET APPROVAL BEFORE EXPENDING ANY FUNDS FOR ANY TYPE OF WORKSHOP OR CONFERENCE. DOES THAT ANSWER YOUR QUESTION? IT'S PRETTY BROAD. [INAUDIBLE] >> THE ISSUES RIGHT NOW, WE HAVE TO DEAL WITH. YOU DON'T HAVE TO DEAL WITH. >> BUT THEY DO HAVE AN IMPACT. ANY OF YOU WHO ARE PLANNING CONFERENCES CERTAINLY DURING THIS FISCAL YEAR BUT EVEN, I WOULD SAY, AT THIS POINT TOWARD THE BEGINNING OF NEXT FISCAL YEAR SHOULD ASSUME YOU'RE GOING TO HAVE FEWER FEDERAL ATTENDEES, AS HAS BEEN THE TRADITION. UNFORTUNATELY THAT'S ABOUT AS FAR AS YOU CAN PLAN. IF IT'S IN D.C., YOU MAY WELL FIND YOURSELF WITH FEWER FEDERAL ATTENDEES HAN YOU'V THAN YOU'VE HAD IN THE PAST FOR ARCANE REASONS. WE'LL DISCUSS MORE OF THOSE FORMALLY AND INFORMALLY LATER, BUT WE SHOULD KEEP MOVING. THANK YOU BOTH KATHY AND ALEXIS. THAT WAS EXTREMELY HELPFUL AND HELPFUL TO MOVE FORWARD TO MORE DISCUSSIONS ABOUT THE SCIENTIFIC PROGRAMS, ET CETERA. IT'S A REAL PLEASURE FOR ME TO INTRODUCE OUR NEXT SPEAKER, WHO IS DR. RICHARD NAKAMURA, WHO BECAME THE DIRECTOR OF OUR CENTER FOR SCIENTIFIC REVIEW AT THE NIH ABOUT SIX MONTHS AGO, BUT I MUST ADMIT FOR SOME REASON, I LIKE TO GIVE CREDIT FOR TIME SERVED AS ACTING DIRECTOR AS WELL, BACK IN SEPTEMBER OF 2011. FOR ANY OF YOU WHO HAVE WONDERED WHAT IT'S LIKE TO MANAGE CSR, LET ME GIVE YOU A FEW FACTOIDS BY THE NUMBERS. I HOPE THESE ARE ACCURATE, RICHARD. THAT AT CSR, THERE ARE ABOUT 450 SCIENTISTS OF ADMINISTRATIVE STAFF. THEY MANAGE ABOUT 80,000 INCOMING GRANT APPLICATIONS A YEAR. SOMEONE BESIDES YOU IS STUDYING THE GRANT APPLICATIONS, 80,000, ABOUT, A YEAR. THAT MEANS ABOUT 1600 REVIEW MEETINGS A YEAR. THAT INVOLVES 18,000 REVIEWERS IN THE SCIENTIFIC COMMUNITY, NO SMALL UNDERTAKING IN ANY SITUATION, BUT I CAN ASSURE YOU THAT RICHARD AND CSR ARE SUFFERING THE SAME BUDGETARY LIMITS AS THE REST OF US ARE THESE DAYS. RICHARD GREW UP ALMOST LITERALLY AT NIH. HE CAME ORIGINALLY NIMH AS A POSTDOC, REMAINED AT NIMH FOR OVER 30 YEARS, WHERE HE HELD EVERY SINGLE LEADERSHIP POSITION I THINK THAT'S POSSIBLE. AT VARIOUS TIMES IN HIS CAREER, HE WAS SCIENTIFIC DIRECTOR, DIRECTOR OF THEIR INTRAMURAL PROGRAM, OFFICE OF THE INVESTIGATOR BEFORE THAT, DEPUTY DIRECTOR, ACTING DIRECTOR. I THINK HE TOOK THE TRASH OUT AT NIGHT. HE REALLY DID EVERYTHING. AND RICHARD, I THINK, IT'S A PARTICULARLY CHALLENGING TIME OBVIOUSLY TO MANAGE CSR, BUT IT'S IN SUCH CAPABLE HANDS BOTH BECAUSE OF WHO HE IS AS A PERSON BUT BECAUSE OF HIS EXPERIENCE AS REALLY A USER OF CSR FOR SOME YEARS. ONE FINAL COMMENT. THE MAGNITUDE OF HIS JOB, I THINK IS UNDERSCORED TO ME. SOME OF YOU HEARD ME SAY THIS BEFORE. WHEN I GO TRAVEL AROUND AT VARIOUS PLACES INCLUDING STANFORD, THIS LAST WEEK. ROUTINELY WHEN I ASK PEOPLE, WHAT DO YOU THINK, WHY IS NIH SO WONDERFUL? PEOPLE MENTION TWO THINGS AND THEY'RE BEING HONEST. ONE IS, ALL THAT MONEY YOU'VE GOT. AND THE SECOND IS PEER REVIEW. THAT IS THE SECRET. IF YOU ASK PEOPLE OUTSIDE THE U.S. THAT'S WHAT THEY ENVY ABOUT THE NIH, IT'S PEER REVIEW. WHEN I THEN ASK THE SAME PEOPLE AT THE SAME VISIT, WHAT ARE THE TWO THINGS ABOUT NIH THAT UH-UH THINK MOST NEED CHANGING, THEY'LL SAY YOU NEED MORE MONEY AND THAT PEER REVIEW SYSTEM NEEDS TO BE FIXED. SO THAT HE HAS A REAL CHALLENGE BECAUSE I THINK IT IS TO FIND SOME MONEY WHICH UNFORTUNATELY WE DON'T DIRECTLY CONTROL, IT IS THAT PART OF NIH PEER REVIEW WHICH IS BOTH MOST LAUDED, MOST ADMIRED, AND WHICH PEOPLE WHO ARE GOING TO PEER REVIEW, EVEN, THINK MOST NEEDS TO BE FIXED. SO THAT'S A DIFFICULT THING TO MANAGE. BUT RICHARD, WE THANK YOU FOR COMING AND TALKING WITH OUR COUNCIL SOMEWHAT, RICHARD, ABOUT CSR AND THE PEER REVIEW PROCESS. >> THANK YOU, ALAN, FOR SUCH A GENEROUS INTRODUCTION. I APOLOGIZE TO YOU FOR SPEAKING FROM A SITTING POSITION. I HAVE HIP OS YOU OSTEOARTHRITIS AND STANDING RIGHT NOW IS A REAL PROBLEM FOR ME. CAN WE GET THE FIRST SLIDE UP? >> WE'RE TRYING TO GET IT PULLED UP FROM YOUR FLASH DRIVE. FOR SOME REASON THE FLASH DRIVE IS NOT SHOWING UP. I APOLOGIZE. >> IT'S ONE OF NIH'S ENCRYPT ENCRYPTED -- >> WE GOT IT. >> ALL RIGHT. ON ONE OF THE RARE OCCASIONS THAT THE PRESIDENT OF THE UNITED STATES HAS MENTIONED PEER REVIEW, I COULDN'T PASS THE OPPORTUNITY TO SHOW THAT OUR PRESIDENT SPOKE GLOWINGLY ABOUT THE IMPORTANCE OF PEER REVIEW IN MAKING SURE THE TAXPAYER DOLLARS ARE USED WELL AT THE NATIONAL ACADEMY OF SCIENCES RECENTLY. THE CSR MISSION IS TO SEE THAT NIH GRANT APPLICATIONS RECEIVE FAIR, INDEPENDENT EXPERT AND TIMELY REVIEWS FREE FROM INAPPROPRIATE INFLUENCES SO NIH CAN FUND THE MOST PROMISING RESEARCH. IN 2012, CSR REVIEWED A LITTLE OVER 69% OF NICHD GRANT APPLICATIONS. THAT INCLUDED OVER 3,000 APPLICATIONS, WHICH IS THE EQUIVALENT OF 12 OF OUR STUDY SECTIONS. THEY AREN'T CLUSTERED NECESSARILY IN 12 STUDY SECTIONS, APPLICATIONS ARE MIXED BY TOPIC AREA AND THIS WOULD INCLUDE MANY, MANY STUDY SECTIONS. TO GIVE YOU A QUICK OVERVIEW, MANY OF YOU KNOW THIS BY HEART, BUT I JUST WANTED TO REPEAT THE PROCESS WHICH IS THAT A P.I. INITIATES A GRANT APPLICATION, IT COULD BE ON THEIR OWN OR IT COULD BE IN RESPONSE TO A REQUEST FOR APPLICATION. THAT IS ASSIGNED TO A PEER REVIEW STUDY SECTION. THAT PEER REVIEW CAN TAKE PLACE EITHER WITHIN THE INSTITUTE OR INTO THE CENTER FOR SCIENTIFIC REVIEW. THOSE APPLICATIONS ARE ASSIGNED TO A STUDY SECTION, THEN THEY ARE RANKED WITHIN THE STUDY SECTION, AND THEN THERE'S A PERCENTILING PROCESS WHICH ESSENTIALLY NORMALIZES THE SCORING ACROSS ALL STUDY SECTIONS. AT THE INSTITUTE, THAT APPLICATION WITH ITS SCORE THEN COMES TO THE INSTITUTE, AND THE INSTITUTE WORKS WITH THEIR COUNSEL AND THE STRATEGIC PLANNING WITHIN THE INSTITUTE TO DETERMINE WHICH OF THOSE APPLICATIONS SHOULD RECEIVE AWARDS, AND AN AWARD DECISION IS MADE AND FUNDING IS PROVIDED. THAT IS THE SECOND STAGE OF PEER REVIEW, AND WE CLEARLY SEPARATE THE RANKING STAGE FROM THE FUNDING STAGE. AND THE RESEARCH IS DONE, PRESUMABLY THERE WILL BE GOOD OUTCOMES AND PUBLICATIONS, AND A CHANGE IN THE PUBLIC HEALTH. AND THEN THAT PROCESS CAN BE REPEATED BY THE INVESTIGATOR OVER TIME. JUST TO REPEAT SOME OF THE NUMBERS THAT YOU WERE GIVEN BEFORE, CSR RECEIVES 85,000 AM ACATIONS, SOME ARE SENT TO THE INSTITUTES DIRECTLY, WE REVIEW, 16,000 REVIEWER, 230 SCIENTIFIC REVIEW OFFICERS, AND ALMOST 1500 REVIEW MEETINGS EACH YEAR. THIS DISMAL GRAPH IS THE OVERWHELMING FACT OF LIFE FOR YOU AND FOR CSR. WHEN I CAME TO NIH AND IT FIRST BECAME -- IN 1979, OUR SUCCESS RATE WAS NEARLY 40%. DOWN AT THE END THERE, THAT LITTLE UPWARD JERK FOR 2012 ACTUALLY IS UNTRUE. IT SHOULD BE FLAT AT 18% SUCCESS RATE. AS YOU CAN TELL FROM OUR PAYLINES, HOWEVER, THE ACTUAL ODDS OF AWARD OF ANY GIVEN APPLICATION ARE HOVERING AROUND 10%. AT ANY RATE, THIS PROLONGED SLIDE AND THE CURRENT SITUATION OF HISTORIC LOWS IN AWARD RATES IS THE OVERWHELMING FACT OF LIFE, AND CONTRIBUTES TO MY GRAY HAIR AND THE FACT THAT OUR SCIENTIFIC CONSTITUENCY IS ALMOST INHERENTLY 90% UNHAPPY WITH WHAT WE DO. AND THE OUTCOMES OF WHAT WE DO. I THINK THERE'S MANY MORE UNDERSTAND THE PROBLEM, BUT WHEN YOU GET A BAD SUMMARY STATEMENT THAT MEANS YOU WON'T GET AN AWARD, THE SCORE ITSELF MAY INDICATE YOU'VE DONE OUTSTANDING WORK, BUT THE SCORE MAY ALSO MEAN FOR MANY INDIVIDUALS THAT THERE WILL BE NO AWARD, SCIENTISTS JUST CAN'T BE UNHAPPY ABOUT THAT, THEY BLAME THE SYSTEM AND THE EASIEST PART OF THE SYSTEM TO BLAME IS CSR, AND WE UNDERSTAND THAT. HERE ARE SOME OF THE ISSUES WE'VE BEGUN TO DEAL WITH. OUR SCORING CHART HAS STAYED THE SAME SINCE ABOUT 2009, WHEN ENHANCING PEER REVIEW WAS SCARTED. STARTED. THIS IS THE 1 THROUGH 9 SYSTEM THAT YOU ARE NOW FAMILIAR WITH. ONE CHARACTERISTIC OF IT WAS THAT THE STRENGTHS AND WEAKNESSES WERE SEEN AS INVERSES OF EACH OTHER. A 9 MEANT MANY WEAKNESSES AND NO STRENGTHS AND 1 WAS SUGGESTED TO MEAN MANY STRENGTHS AND NO WEAKNESSES. SOME INDIVIDUAL REVIEWERS WERE BEGINNING TO LOOK AT THAT INVERSE AS THE LAW AND THAT IF THERE WERE NO WEAKNESSES, THERE SHOULD BE A GOOD SCORE OF A 1 OR A 2. THIS WAS CLEARLY A DISTORTION OF ORIGINAL INTENT OF ENHANCING PEER REVIEW. NIH HAS ALWAYS BEEN INTERESTED IN HAVING APPLICATIONS AWARDED THAT HAD GREAT SIGNIFICANCE, AND IN ORDER TO MAKE SURE NO REVIEWERS COULD MISINTERPRET IT, WE CHANGED THE SCORING CHART. AND THIS ACTUALLY LOOKS MORE DIFFERENT THAN IT ACTUALLY IS. ALL THIS DOES IS TO EMPHASIZE THAT YOU SHOULD NOT BE IN THAT HIGHEST 1 THROUGH 3 SECTION OF THE SCORING UNLESS THE APPLICATIONS IMPABT WILL BE VERY HIGH, THAT THE SIGNIFICANCE IS HIGH, AND THOSE TERMS ARE MEANT TO EMPHASIZE THAT POINT. THAT YOU COULD BE AT THE VERY LOWEST RANGE WITH A MODERATE INTEREST OR MODERATE SIGNIFICANCE AND SIGNIFICANT WEAKNESSES OR NO WEAKNESSES AND NO INTEREST. THE OTHER THING WE EMPHASIZED WAS THAT 5 WAS A GOOD MODERATE SCORE. IN THE OLD SCORING SYSTEM, A 5 WAS A VERY BAD SCORE. PEOPLE WERE VERY RELUCTANT TO USE IT, WHICH MEANT THAT MANY INDIVIDUALS WERE SQUEEZING THEIR SCORES BETWEEN 1 THROUGH 5 RATHER THAN 5 THROUGH 9. IT HAS SIGNIFICANTLY CHANGED SCORING. THIS IS AN EXAMPLE, THIS ACTUALLY LOOKS FAIRLY SUBTLE. BUT IF WE LOOK AT THE AWARD RANGE, THE MOST RECENT ROUND OF SCORING ENDED UP, WE HAVEN'T COMPLETED THE SHIFT BUT THIS IS ABOUT A 30% CHANGE IN THE SCORING THAT INDIVIDUALS ARE DOING. ONE THING OF INTEREST AND HEAVILY DISCUSSED BY US IS THAT JUMP AT THE SCORE OF 20. IT INDICATES THAT REVIEWERS ARE CLUSTERING THEIR SCORES AROUND 10, 20, 30. THIS IS, IN FACT, THE SCORES THAT COME OUT OF PEER REVIEW, AND THESE ARE THE SCORES GIVEN TO INDIVIDUAL SCIENTISTS, TENS OF THOUSANDS ARE REPRESENTED HERE, AND YOU CAN SEE HUGE PEAKS AROUND 10, 20, 30, 40 WITH THE HIGHEST PEAK AT 20. REVIEWERS ARE AWARE THAT 20 IS PROBABLY THE LAST HOLDOUT FOR POSSIBLE AWARDS. THINGS ARE BEING CLUSTERED TIGHTLY THERE, BUT THEY CANNOT SPREAD SCORES OUT ENOUGH TO PROVIDE GOOD INFORMATION TO YOU OR TO PROGRAM STAFF ABOUT WHAT THEIR TRUE RANKING OF APPLICATIONS IN FRONT OF THEM ARE. THIS IS A SOURCE OF HEAVY DISCUSSION. WE KNOW THAT THE SAME PATTERN APPEARED WITHIN THE OLD SCORING SYSTEM, SO IT ISN'T JUST A MATTER OF NOT HAVING ENOUGH POINTS BETWEEN INDIVIDUAL SCORES. THERE IS A PATTERN TO CLUSTER SCORES, PERIOD. SO WE ARE HAVING DISCUSSIONS AROUND THIS TOPIC NEXT. WHEN I FIRST CAME ON BOARD AS AN ACTING DIRECTOR OF CSR. THE PAPER INDICATED THERE WERE SIGNIFICANT DISPARITIES BETWEEN AWARD RATES FOR AFRICAN-AMERICAN SCIENTISTS AND FOR OTHERS HAS HIT THE NEWS. IT HIT NIH LIKE A THUNDERCLAP. IT BASICALLY UNDERMINED OUR CONFIDENCE THAT NIH STOOD FOR FAIRNESS BOTH IN REVIEW AND IN AWARDS, AND INSTANTLY BOTH THE DIRECTOR AND MANY STAFF MEMBERS INCLUDING CSR, WE STARTED TO WORK TO TRY AND UNDERSTAND EXACTLY WHAT WAS GOING ON. IN THE ORIGINAL PAPER, IT WAS NOTED THAT APPLICATIONS WITH STRONG PRIORITY SCORES HAD EQUAL CHANCES TO BE AWARDED, BUT THAT AFRICAN-AMERICAN SCIENTISTS WERE 10 PERCENTAGE POINTS LESS LIKELY TO RECEIVE RESEARCH FUNDING, COMPARED TO WHITE SCIENTISTS, OR ACTUALLY FOR ALL OTHER SCIENTISTS. THE FIRST BULLET RAISED THE SUGGESTION THAT THE PROBLEM WAS NOT AFTER THE SCORING. THAT IS WITH THE SAME SCORE, THE SAME AMOUNT OF FUNDING OR AWARDS WERE MADE, THAT MEANT THAT THE PROBLEM WAS AT OR BEFORE PEER REVIEW. THIS 10 PERCENTAGE POINTS DIFFERENCE ALSO, I THINK, REDUCED THE SUGGESTED DIFFERENCE BETWEEN AFRICAN-AMERICAN SCIENTISTS AND WHITE SCIENTISTS. LET ME PUT THOSE NUMBERS IN ANOTHER WAY. FOR AN EQUAL NUMBER OF APPLICATIONS BY AFRICAN-AMERICAN SCIENTISTS AND WHITE SCIENTISTS, AFRICAN-AMERICAN SCIENTISTS WILL RECEIVE 55% OF THE AWARDS OF THE WHITE SCIENTISTS. SO THE ACTUAL DIFFERENCE -- THE ACTUAL DISPARITIES IN NUMBERS OF AWARDS WAS QUITE LARGE. MORE THAN SIGNIFICANT. SO SUGGESTED EXPLANATIONS HERE WHERE IT WAS THAT THERE WAS BIAS IN PEER REVIEW. AS MANY OF YOU KNOW, ANY TIME WE'VE REALLY INVESTIGATED WHETHER OR NOT THERE IS BIAS BASED ON RACE IN THIS COUNTRY, WE FOUND IT. THE OTHER SUGGESTION WOULD BE THERE MAY BE A CUMULATIVE DISADVANTAGE BECAUSE OF DIFFERENTIAL EDUCATION SYSTEMS WITHIN THIS COUNTRY THAT REALLY DIFFERENTIATES IS AVAILABLE TO DIFFERENT RACIAL POPULATIONS IN DIFFERENT PROPORTIONS. CSR, AMONG OTHERS, TOOK IMMEDIATE ACTION. IF YOU GO TO THE ADVISORY COMMIT THE EE TO THE DIRECTOR WEBSITE AND LOOK THERE, THERE ARE SEVERAL PAPERS ON DIVERSITY AND WHAT THE ADVISORY COMMITTEE HAS MADE INITIAL RECOMMENDATIONS ABOUT. NIH HAS BEEN ACTIVELY PURSUING THOSE INCLUDING SOME VERY LARGE GRANT MECHANISMS IN ORDER TO TRY AND DO SOMETHING ABOUT THIS PROBLEM WITHIN CSR. WE SET UP A PEER REVIEW COMMITTEE TO LOOK SPECIFICALLY AT THE PROBLEMS THAT MAY EXIST WITHIN PEER REVIEW. WE'RE TRYING TO PROVIDE MORE INFORMATION FOR NON-DISCUSSED APPLICATION, AFRICAN-AMERICAN SCIENTIST APPLICATIONS ARE NOT DISCUSSED AT HIGHER RATES THAN OTHER APPLICATIONS. WE'RE DOING A TEXT ANALYSIS -- WE'RE PROVIDING MORE -- LET'S SEE, WE'RE DOING A TEXT ANALYSIS OF APPLICATIONS, SUMMARY STATEMENTS, IN ORDER TO SEE IF THERE ARE DIFFERENCES IN THE WORDING OF THOSE STATEMENTS IF THERE MIGHT BE CODE WORDS THAT SUGGEST DIFFERENCES OR BIAS. WE'RE DOING EVALUATIONS OF POSSIBLE ANON-MYIZATION OF APPLICATIONS TO SEE IF ANY SIGNS OF BIAS OR DISPARITY DISAPPEARS WHEN YOU ANON-MIEZ APPLICATIONS, AND WE ARE ALSO TALKING ABOUT DIVERSITY AWARENESS TRAINING FOR REVIEW STAFF. NEXT SLIDE. UNDER THE GUIDANCE OF NIH AND PARTICULARLY FRANCIS AND LARRY TABAK, THEY'VE BEEN ENCOURAGING US TO RELOOK AT THE NUMBER OF REVIEWERS FROM UNDERREPRESENTED MINORITY POPULATIONS TO SEE IF WE ARE KEEPING UP THOSE NUMBERS. IT WAS NOTICED THAT THE NUMBERS HAD DROPPED FROM 2006 THROUGH 2011. THE NUMBERS IN YELLOW HIGHLIGHTED IN YELLOW INDICATE THE CHANGES THAT HAVE OCCURRED SINCE I'VE TAKEN OVER, I HAVE TO SAY THAT THIS IS WITH STRONG ENCOURAGEMENT FROM BUILDING ONE, WE HAVE BEEN ABLE TO INCREASE AFRICAN-AMERICAN PARTICIPATION AND REVIEW BY 44%, HISPANIC BY 22%. OVERALL OVER THE LAST YEAR, WE'VE INCREASED THE PROPORTION OF UNDERREPRESENTED MINORITY SCIENTISTS ON OUR REVIEW COMMITTEES BY 25%. THIS IS CERTAINLY NOT PERFECT, BUT BY HAVING 10% UNDERREPRESENTED MINORITY SCIENTIST REPRESENTATION, SO FAR THAT IS DOUBLE THE AWARDS CURRENTLY BEING GIVEN, AND WE HOPE THAT WILL CHANGE THE PERSPECTIVE OF OUR COMMITTEES AND HELP ENSURE THAT WE ARE NOT BIASED IN REVIEW. SOME QUESTIONS HAVE BEEN ASKED ABOUT ARE WE TRYING TO GET THE BEST REVIEWERS AND WE ARE WE KEEPING UP THAT. THIS IS THE OVERALL PROPORTIONS OF ACADEMIC RANK. WE LOOK AT SEVERAL DIFFERENT THINGS FOR OUR REVIEWERS. ONE, WE LOOK FOR STRONG SCIENTIFIC SUPPORT, STRONG PUBLICATION ACTIVITY, BUT RANK IS EASIER TO PUT IN NUMBERS, AND SO THIS IS JUST TO SHOW YOU THAT FULL PROFESSORS AT THE BLUE LINE IS HANGING AROUND 70% AND AROUND 20% FOR ASSOCIATE PROFESSORS, AND WE HARDLY EVER APPOINT ASSISTANT PROFESSORS ON TO STANDING STUDY SECTIONS IN THE FEW CASES THAT WE HAVE, IT LOOKS LIKE INDIVIDUALS WHO HAVE HAD MULTIPLE NIH GRANTS ON THE VERGE OF TENURE ARE THOSE THAT MIGHT BE SELECTED. WE ALSO USE A LOT OF AD HOCS. YOU DON'T GET 16,000 REVIEWERS AAT THIS KIND OF LEVEL, SO IT'S ONLY 50% FOR FULL PROFESSORS, 30% FOR ASSOCIATE PROFESSORS, AND THEN WE'RE UP TO 10% ON ASSISTANT PROFESSORS. AGAIN, WE TAKE A LOOK TO MAKE SURE THAT THESE ARE KNOWLEDGEABLE INDIVIDUALS. I'LL ALSO MENTION WE ARE TRYING TO HELP EARLY CAREER SCIENTISTS BY CREATING AN EARLY CAREER REVIEWER PROGRAM IN WHICH THE INDIVIDUALS ARE RECRUITED FROM UNIVERSITIES BASED ON UNIVERSITY SUGGESTION THAT THESE ARE RESEARCHERS INTENDED TO DEVELOP INDEPENDENT RESEARCH CAREERS THAT THEY WANT TO HAVE RESEARCH GRANTS FROM NIH AND THEY ALREADY HAVE A STRONG PUBLICATION TRACK RECORD. WE BRING THEM ON TO COMMITTEES AS REVIEWERS BUT AS TEA AS TERTIARY REVIEWERS FOR ONE ROUND A YEAR AS A WAY TO ACQUAINT THEM WITH PEER REVIEW AND TO HELP THEM UNDERSTAND HOW THE SYSTEM WORKS. WE ENRICH THIS FOR UNDERREPRESENTED MINORITY SCIENTISTS, BUT SCIENTISTS OF ALL INSTITUTIONS AND OF ALL POSITIONS ARE ENCOURAGED TO SIGN UP FOR THIS. WE HAVE TRAINED OVER 700 SCIENTISTS SO FAR, AND THIS HAS BEEN SEEN AS QUITE SUCCESSFUL. WE ARE LOOKING TO SEE WHETHER OR NOT THEY RECEIVE GRANTS THEMSELVES AND AT WHAT RATE. FOR THE FUTURE, WE ARE LOOKING FOR A BETTER DISTRIBUTION OF APPLICATIONS ACROSS STUDY SECTIONS. THEY'RE DISTRIBUTED RANDOMLY BY SUBJECT BASED ON A REQUEST BY THE PIs. SROs ARE VARIABLY SUCCESSFUL IN RECRUITING TOP SCIENTISTS FOR THEIR COMMITTEES, AND THIS COMBINATION MEANS THAT THERE MAY BE AN ACCUMULATION OF SOME OF THE TOP APPLICATIONS WITHIN A SUBSET OF OUR COMMITTEES. THIS POSSIBILITY IS OF GREAT CONCERN, AND WE ARE LOOKING AT THIS TO FIGURE OUT WAYS EITHER THAT WE COULD RANDOMIZE DISTRIBUTION OF APPLICATION, EVERYONE HAS SAID THUMBS DOWN ON THAT, OR THAT WE COULD PROVIDE INFORMATION TO THE INSTITUTES AND TO COUNCIL ABOUT RELATIVE WEIGHTING SO THAT YOU CAN MAKE CHOICES IN YOUR SELECTIONS WHETHER OR NOT MORE OR LESS APPLICATIONS COULD BE SELECTED FOR AWARD DEPENDING ON THE COMMITTEE BASED ON THIS KIND OF INFORMATION. WE ARE LOOKING TO INCREASE DIVERSITY BOTH IN OUR AWARDS AND OUR COMMITTEES, AND REDUCE THE AWARD DISPARITIES THAT WE'VE SEEN. WE ARE TRYING TO DEVELOP BETTER TOOLS AND SERVICE TO APPLICANTS AND TO ICs. WE'RE TRYING TO RESTORE FULL THOUGHTS IN OUR SUMMARY STATEMENTS, WHILE WE'VE RETAINED BULLETS, WE'VE ASKED THAT FULL SENTENCES BE USED AND THAT FULL PARAGRAPHS BE USED IN SUMMARIES TO PROVIDE MORE INFORMATION TO PROGRAM STAFF AND TO UH-UH. YOU. WE ARE ALSO TRYING TO MAKE THE GRANT SYSTEM MORE USER-FRIENDLY, CONSTANTLY GIVING FEEDBACK TO ERA AND TO OTHER INPUT MECHANISMS OF NIH TO TRY AND ENSURE THAT THE FEEDBACK GIVEN TO PIs ABOUT ERRORS AND MISTAKES IS CLEARER AND MORE TIMELY, AND WE OFTEN LET THINGS IN WHEN WE FEEL THAT THE INFORMATION PROVIDED BACK TO THE P.I. IS SO AMBIGUOUS AS TO RENDER ITS INTERPRETATION PROBLEMATIC. FINALLY, WE WANT TO DEVELOP A SCIENCE PEER REVIEW. FRANCIS COLLINS HAS MADE IT POSSIBLE FOR US TO HANG ON TO SOME MONEY THAT WE SAVE AS A RESULT OF ELECTRONIC REVIEWS OF CERTAIN KINDS OF APPLICATIONS SO THAT WE CAN USE THAT MONEY TO CONDUCT ACTUAL TRIALS AND TO DO RESEARCH SO THAT WE TRY THINGS OUT BEFORE WE SPRING THEM ON THE UNSUSPECTING SCIENTIST POPULATION. TO TRY AND MAKE SURE THAT THINGS WORK AND THAT THEY ARE, IN FACT, HELPFUL. SO THOSE ARE THE KINDS OF THINGS WE ARE WORKING ON IN TRYING TO MAKE CSR WOUL BOTH A SCIENCE AND RESPONSIVE TO COUNCIL AND TO THE SCIENTIFIC COMMUNITY. THANK YOU. >> THANK YOU VERY MUCH, RICHARD. LET ME ASK YOU ONE QUESTION BECAUSE IT'S ONE I HEAR A LOT AND IT CAME UP IN YOUR TALK. CAN YOU TALK MORE ABOUT THE DIFFERENCE BETWEEN PAYLINE AND SUCCESS RATE. PEOPLE OFTEN LOOK AT ME AND SAY, GEE, YOU EITHER PAY IT OR YOU DON'T, SO HOW CAN YOU HAVE A SUCCESS RATE THAT'S ALMOST TWICE WHAT THE PAYLINE IS. HOW DO YOU DO THAT? >> NIH ASKED THE QUESTION, HOW SUCCESSFUL IS ANY GIVEN APPLICATION. SO TRUE THE NUMBER OF AMENDMENTS THAT IT GOES THROUGH, THAT'S ALL ONE APPLICATION. SO IF YOU HAVE TWO -- AN A0 AND AN A1, THAT IS TREATED AS ONE APPLICATION. BY CUTTING SIGNIFICANTLY THE NUMBER OF APPLICATIONS THAT YOU'RE USING IN THE PROCESS, THE PROPORTION OF AWARD SEEMS A LITTLE HIGHER. IT'S ALSO REASONABLE THAT YOU'D BE ASKED WHETHER OR NOT AN ATTEMPT TO GET MONEY THROUGH SEVERAL AWARDS, THROUGH SEVERAL AMENDMENTS, IS ULTIMATELY SUCCESSFUL. THAT'S THE CRITERIA NIH USES. BECAUSE OF THAT, SUCCESS RATE IS ALWAYS HIGHER THAN ONE'S SENSE OF WHETHER THE ODDS OF ANY GIVEN AWARD BEING FUNDED. >> ANSWERED MORE SUCCINCTLY THAN I USUALLY DO. THANK YOU. SO HERE IS YOUR CHANCE TO SPEAK TO THE HEAD. CSR. I'M SURE THERE'S BOTTLED UP THOUGHTS YOU HAVE. UNBOTTLE THEM. >> THANK YOU VERY MUCH FOR YOUR PRESENTATION, AND I REALLY APPRECIATE THE COMPLEXITY OF THE PROCESS AND THE INTRICACIES INVOLVED IN IT, AND I REALLY LIKE YOUR LAST BULLET POINT ABOUT LOOKING AT THE QUALITY OF THE REVIEW. INHERENT TO THIS PROCESS IS AN ISSUE THAT I THINK YOU MIGHT HAVE TOUCHED ON BUT I'M NOT 100% SURE HOW MUCH ATTENTION IT GETS AND THAT'S THE ISSUE OF DIVERSITY OF SCORES WITHIN THE STUDY SECTION, SO WHAT HAPPENS, WE'RE GOING TO SEE THIS AFTERNOON ALSO, IS THAT A DISCUSSION DOES NOT ACHIEVE ITS FULL DEPTH AND SOMETIMES IT'S BECAUSE OF VERY DOMINANT PEOPLE ON A STUDY SECTION AND PEOPLE WHO ARE VERY KNOWLEDGEABLE BUT NOT AS DOMINANT. SOMETIMES IT'S BECAUSE OF PRESSURE, BECAUSE IT'S LATE IN THE DAY AND PEOPLE ARE LOOKING AT FLIGHTS AND SO FORTH. IT DOES -- THAT SERVICE FOR THE REVIEW PROCESS AND OF COURSE TO THE APPLICANT. I KIND OF CALL IT VOTE YOUR CONSCIENCE SYNDROME BECAUSE PEOPLE IN OFFICIAL DISCUSSION SAY VOTE YOUR CONSCIENCE AND EVERYBODY PUTS A SCORE BUT THEY'VE NOT REALLY HAD A CHANCE TO HAVE A REALLY MEANINGFUL DISCUSSION. SO I WONDER IN YOUR THOUGHTS ABOUT IMPROVING THE QUALITY, HOW MUCH ATTENTION ARE YOU PAYING TO THE ROLE OF THESE SROs, AND ALSO THE CHAIRPERSON, THE SCIENTIFIC CHAIRPERSON, TO GUIDING THE DISCUSSIONS IN A MANNER THAT WILL DIMINISH THOSE APPEARANCES? >> YES. THESE ARE VERY IMPORTANT ISSUES. WE'RE SPENDING MORE TIME TRAINING NEW CHAIRPERSONS. WE ARE, IN FACT, THE SILVER LINING IN THE AWFUL FUNDING SITUATION IS THAT WE ARE GETTING AMAZING SCIENTISTS COMING ON BOARD TO BECOME SROs. WHO HAVE A LOT OF EXPERIENCE IN PEER REVIEW THEMSELVES, WHO HAVE HAD A LOT OF EXPERIENCE WITH GRANTS, UNDERSTAND WHAT THE SCIENTIFIC COMMUNITY IS GOING THROUGH, AND ARE BEING QUITE ACTIVE IN MAKING SURE THAT TRYING TO DISTRIBUTE THE TIME THAT THE COMMITTEES HAVE IN THE MOST APPROPRIATE PLACE, BOTH THEY AND THE CHAIRS ARE WORKING HARD TOGETHER. I AM TRYING ALSO TO CREATE MORE CHANNELS OF COMMUNICATION SO THAT WE CAN GET FEEDBACK WHERE THIS MIGHT NOT BE WORKING IN ANY GIVEN STUDY SECTION. SO THESE ARE INCREDIBLY IMPORTANT POINTS. I SIT IN ON STUDY SECTIONS, OUR DIVISION DIRECTORS SIT IN ON STUDY SECTIONS, OUR IRG CHIEF SITS IN ON STUDY SECTIONS, ALL TRYING TO MAKE SURE THAT THERE'S A REASONABLY GOOD EXPERIENCE AND A REASONABLE DISTRIBUTION OF TIME IN ORDER TO FOCUS IN WHERE THE TIME NEEDS TO BE MOST FOCUSED. YOU'RE ABSOLUTELY RIGHT, THINGS ARE TIGHT, PEOPLE CAN'T START RUSHING TO THE AIRPORT AND IF IT'S REALLY UP TO THOSE SRO AND CHAIRMAN JERS TO MAKE SURCHAIR -- IT CAN G O BEAUTIFULLY AND THERE CAN BE PROBLEMS, AND WE HAVE BEEN SYSTEMATICALLY TRYING TO WORK AT BOTH THE TOP AND THE BOTTOM ENDS OF OUR STAFF TO TRY AND IMPROVE THE SITUATION. >> I JUST WANT TO RECOMMEND THAT EVERY CHAIRPERSON WILL SEE THE MOVIE "12 ANGRY MEN" WITH HENRY FONDA BEFORE STUDY SECTION. [LAUGHTER] >> THANKS. >> RICHARD, LET ME ASK YOU, I KNOW YOU HAVE A HARD STOP AND WE'VE ALREADY TAKEN YOU BEYOND YOUR APPOINTED TIME. >> I CAN TAKE A LAST QUESTION AND THEN I'LL RUN FOR THE -- >> IT WAS A GREAT PRESENTATION. WE'D LOVE TO HAVE ACCESS TO YOUR SLIDES TO EDUCATE OUR COMMUNITY. BUT MY QUESTION FOR YOU IS, GIVEN THE RAPID CHANGES IN SCIENCE AND TECHNOLOGY, HOW OFTEN DO YOU REVIEW THE VARIOUS STUDY SECTIONS, THE CONTENT OF WHAT'S COVERED BY EACH STUDY SECTION AND THE DECISION TO ADD IN THE NEW STUDY SECTION? >> WE ARE CURRENTLY REDESIGNING OUR WAY OF REVIEWING IT, AND THE FIRST THREE IRGs -- WE'RE DOING THIS BY IRGs, WHICH IS GROUPINGS OF EIGHT TO 10 STUDY SECTIONS. THE FIRST TREE AR THREE ARE COMING UP THIS SUMMER. THIS PROCESS IS BEING LOOKED AT WITH GREAT INTEREST ALL ACROSS NIH, AND PARTICULARLY BY BUILDING ONE OR THE FRANCIS COLLINS AND LARRY TABAK. >> THANK YOU VERY MUCH, RICHARD. THAT WAS VERY HELPFUL. WE APPRECIATE YOUR TAKING THE TIME TO DO THIS. THANK YOU. NEXT, WE WILL HAVE OUR ANNUAL DISCUSSION OF OUR STATEMENT OF UNDERSTANDING, WHICH BRYAN WILL TAKE US THROUGH. >> GOOD MORNING. IT'S MY PLEASURE TO CONDUCT THE ANNUAL REVIEW OF THE STATEMENT OF UNDERSTANDING. THIS IS THE COUNCIL OPERATIONS PROCEDURES, AND THIS DOCUMENT IS AN AGREEMENT BETWEEN THE NICHD STAFF AND U AS THE NICHD ADVISORY COUNCIL. THIS HAS BEEN MADE AVAILABLE ON THE COUNCILMEMBER WEBSITE. HOPEFULLY YOU'VE BEEN ABLE TO REVIEW IT. IF YOU HAVEN'T, YOU CAN -- AFTER COUNCIL, ON YOUR LEISURE. I WILL GO THROUGH EACH OF THE SECTIONS BRIEFLY, AND IF YOU HAVE ANY QUESTIONS, PLEASE LET ME KNOW. THERE'S ONE CHANGE IN THE STATEMENT OF UNDERSTANDING FROM LAST YEAR. WHEN I GET TO THAT SECTION, I'LL DISCUSS THAT CHANGE. SO THE FIRST SECTION IS THE MAKEUP OF THE COUNCIL STRUCTURE, WHICH INCLUDES 24 MEMBERS. THERE ARE SIX OFFICIO -- EX-OFFICIO MEMBERS, INCLUDING THE SECRETARY OF HHS, THE NIH DIRECTOR, AND NICHD DIRECTOR. THERE ARE THEN 18 APPOINTED MEMBERS, YOURSELVES THAT ARE APPOINTED BY HHS SECRETARY. THE NEXT SECTION DEALS WITH THE SECONDARY REVIEW OF GRANT APPLICATIONS, AND THAT IS ONE OF THE PRIMARY RULES OF COUNCIL. THERE ARE MANY ACTIONS THAT ARE REVIEWED DURING CLOSED SESSION, AND SO SOME OF THESE ARE THE CONVERSION OF RO1s TO R37s, WHICH ARE THE MERIT AWARDS. THERE'S ALSO THE MERIT EXTENSION, AND THEN ANY FOREIGN APPLICATIONS, THEY NEED TO BE PRESENTED INDIVIDUALLY TO COUNCIL, AND ALSO ANY TRANSFERS OF FOREIGN -- GRANTS TO FOREIGN INSTITUTION OR BETWEEN FOREIGN INSTITUTIONS MUST BE PRESENTED TO COUNCIL. STAFF RECOMMENDATIONS FOR COFUNDING ARE BROUGHT BEFORE COUNCIL. ALSO RFAs, SUMMARY STATEMENTS OF SPECIAL INTEREST OR SPECIAL POLICY ISSUES ARE RAISED. THE HPP, HIGH PROGRAM PRIORITY APPLICATIONS, ARE PRESENTED AS WELL AS THE LPPs, THE LOW PROGRAM PRIORITY. AND APPEALS ARE ALSO BROUGHT TO COUNCIL. THE LAST SPECIAL ACTION INCLUDED HERE IS THE SPECIAL COUNCIL REVIEW. THESE ARE FOR GRANTEES THAT HAVE $1 MILLION OR MORE IN FUNDING, AND THIS IS TOTAL COST. NOW THIS IS A CHANGE FROM LAST YEAR, WE HAVE BEEN USING THIS IN COUNCIL, BUT THE DOCUMENT ITSELF WAS REVISED TO INCLUDE THAT FROM LAST YEAR. THE NEXT SECTION INCLUDES THOSE DECISIONS THAT DO NOT REQUIRE COUNCIL RECOMMENDS, AND THAT'S THE CHANGE OF PI, CHANGE OF INSTITUTION, AND ALSO APPLICATIONS THAT ARE DEFERRED PRIOR TO THE COUNCIL MEETING. NOW THE OPTIONS TO COUNCIL -- AS A COUNCIL ARE CONCURRENCE WITH SRG RECOMMENDATIONS, THE NON-CONCURRENCE, YOU CAN ALSO -- I MENTIONED HP P&L PP THAT ARE RECOMMENDED BY STAFF. COUNCIL CAN ALSO BRING UP RAISE HPPs OR RECOMMEND THAT AN APPLICATION BE LPP, THE LOW PROGRAM PRIORITY. THEN THERE'S ALSO THE OPTION OF DEFERRAL TO OBTAIN FURTHER INFORMATION. WE'VE HAD THAT AS AN OPTION AS WELL. WE HAVE A SECTION INCLUDED IN THE STATEMENT OF UNDERSTANDING, WE HAVEN'T EXERCISED THAT IN A NUMBER OF YEARS, BECAUSE OF -- PRIMARILY BECAUSE OF THE PAYLINES THAT WE'RE NOT ABLE TO EXERCISE THIS. WHAT THIS WOULD DO, THOUGH, IS TO ALLOW US TO AWARD CERTAIN APPLICATIONS, THE PARAMETERS ARE INCLUDED HERE, EARLIER, PRIOR TO COUNCIL. IT'S EXPLAINED IN DETAIL IN THAT SECTION. WE ALSO HAVE INTERIM REVIEW, THIS IS PRIMARILY USED WITH OUR WHAT'S CALLED ROAD MAP APPLICATIONS OR IN SOME CASES WHERE WE MAY HAVE TO CONDUCT RE-REVIEW, IF THE COUNCIL IN BETWEEN THE REGULARLY SCHEDULED COUNCILS. THEN THERE'S ALSO THE CONCEPT REVIEW, AND THIS IS CONDUCTED DURING OPEN SESSION, WILL BE CONDUCTED HERE AT THIS COUNCIL AS WELL. THE OPTIONS ARE APPROVAL, DISAPPROVAL OR APPROVAL WITH RECOMMENDATIONS FOR SPECIFIC MODIFICATIONS. THEN WE ALSO HAVE A SEC SHOULD SECTION FOR EMERGENCY PROCEDURES, INCLUDED FOR EMERGENCIES SUCH AS POSSIBLE -- OR OTHER TYPES OF EMERGENCY SITUATIONS. WE COULD CONDUCT TELECONFERENCE. WE DO CONDUCT REMOTE COUNCIL ATTENDANCE, SO THIS WILL HELP US IN THE FUTURE IF WE EVER NEEDED TO CONDUCT A REVIEW OF ALL COUNCILMEMBERS IN THAT FASHION. SO THERE ARE OTHER CONDITIONS, ONLY CLOSED SESSION FOR SECONDARY REVIEW, UTILIZE ONLINE VOTING IF NECESSARY, CHANGE OF MEETING LOCATION, AND/OR HOLD AN INTERNET-ASSISTED MEETING, AS I MENTIONED. SO THAT'S THE STATEMENT OF UNDERSTANDING, AND AS I SAID, IT'S INCLUDED IN THE COUNCILMEMBER WEBSITE, IT'S INCLUDED AS A DRAFT NOW BECAUSE IT DOES REQUIRE YOUR APPROVAL, AN.>> THE WAY WE DO THIS, WE DON'T ACTUALLY TAKE A MOTION OR VOTE ON IT, BUT WE ASK IF THERE ARE ANY CONCERNS OR ANY ISSUES WITH IT. BRYAN, YOU HAVE IT IN THE DOCUMENT, BUT I THINK YOU STATED IT BACKWARDS. IT'S $1 MILLION IN DIRECT COSTS. HE HAS THE CORRECT COMMENT IN THE DOCUMENT ITSELF. >> THAT'S RIGHT. THE REASON IT WAS -- >> IT IS DIRECT. $1 MILLION IN DIRECT. IT HAS BEEN TOTALS IN THE DOCUMENT THAT WE GOT YOUR CONCURRENCE ON PRIOR. >> IT WAS $1.5 MILLION TOTAL COST, AND WE TYPICALLY PUT OUT DIRECT COSTS BECAUSE OF THE DIFFERENT -- THE VARIANCE IN INDIRECT COST RATES. SO IN FAIRNESS, IT'S $1 MILLION IN DIRECT COSTS AND THE INDIRECT COSTS ARE APPLIED TO THAT. >> ARE THERE ANY COMMENTS OR CONCERNS? SO DO WE KEEP OUR STATEMENT OF UNDERSTANDING WITH THE COUNCIL AS BRYAN HAS PRESENTED TO YOU? ANYONE ON THE PHONE YET? ANYBODY ON THE PHONE? OKAY. THEN WE'VE GOT COUNCIL'S REPORT. >> THANK YOU VERY MUCH. WE'RE GOING TO TAKE A BREAK NOW. WE'RE GOING TO START PROMPTLY AT 25 MINUTES AFTER THE HOUR. SO A 15-MINUTE BREAK, QUICK BREAK, AND WE WILL START AGAIN AT 10:25 FOR ANYBODY WHO'S OUT THERE LISTENING TO US, TAKE A BREAK TOO. WE'LL BE BACK AT 10:25. NEXT UP I'M HAPPY TO SAY WE HAVE A WONDERFUL PRESENTATION ON BIG DATA. I KNOW THAT BECAUSE I KNOW THE SPEAKER WHO IS BOTH TRULY AN EXPERT IN THIS AREA. HE'S ERIC GREEN WHO SPENT A LOT OF TIME THINKING ABOUT THE QUESTIONS OF BIG DATA IN HIS DAY JOB WHICH SINCE DECEMBER OF 2009, HE HAS BEEN DIRECTOR OF WHAT IS COMMONLY REFERRED TO IN THE GUTTMACHER HOUSEHOLD AS THE SECOND MOST IMPORTANT -- I'VE GOTTEN TO KNOW ERIC OVER THE YEARS DURING OUR TIME TOGETHER AT THE GENOME INSTITUTE. ERIC ORIGINALLY CAME AS THE INTRAMURAL PROGRAM THIS WAS GETTING STARTED TO BE INNAUG GRAL DIRECTOR OF THE SEQUENCING CENTER WHICH HE DID WITH INCREDIBLE ABILITY. BECAUSE OF THAT, BECAME THE SCIENTIFIC DIRECTOR THE MURAL DIRECTOR AT NIH GRI WHICH HEHIDID FOR A NUMBER OF YEARS BEFORE BECOMING IN DECEMBER OF 2009 THE CORRECTOR OF NHGRI. HE'S A SUPERB SCIENTIST IN HIS OWN RIGHT AND HAS DONE SOME REALLY WONDERFUL THINGS. PLAYED A REAL ROLE, UM, IN THE VERY BEGINNING, REALLY, OF THE HUMAN GENOME PROJECT AMONGST OTHER THINGS HE'S BEEN INVOLVED IN, AND CLEARLY AS YOU HEARD FROM THAT REALLY FOR HIS WHOLE LIFETIME, HE'S BEEN PROVIDING BIG DATA BUT ALSO GRABBING WITH THE QUESTION OF HOW DO WE DEAL WITH BIG DATA. IT'S BECOME CLEAR TO NIH THAT WE NEED TO THINK ABOUT THIS IN A MUCH LARGER SENSE ACROSS THE ENTIRE NIH. DR. COLLINS DECIDED TO CREATE THIS NEW POSITION OF ASSOCIATE DIRECTOR OF NIH FOR DATA SCIENCE WHICH IS REALLY TO HELP US FIGURE OUT HOW DO WE DO THIS WHOLE BIG DATA THING AND WHILE WE'RE HAVING TO SEARCH FOR THAT, ASKED ERIC TO STEP IN ON TOP OF HIS DAY JOB TO GET HIS EFFORTS ACROSS NIH UP AND RUNNING. SO WE THOUGHT IT'D BE USEFUL TO COUNCIL BOTH FOR WHAT YOU DO IN YOUR DAY JOBS BUT ALSO AS OUR A ADVISORS BECAUSE QUESTIONS OF BIG DATA ARE CREASINGLY IMPORTANT TO NICHG DIRECTLY SO THOUGHT IT'D BE GREAT TO GET ACTING DIRECTOR OF THIS EMPTY BUT ALSO SOMEONE WHO'S SPENT MANY YEARS AS A LEADER IN THE SCIENTIFIC COMMUNITY THIG ABOUT BIG DATA TO COME TALK WITH YOU ABOUT IT. THAT AND HE'S A GREAT SPEAKER. HAVE AT IT. >> IT'S A PLEASURE TO BE HERE. IF WE CAN GET SOMEONE TO GET TO DIM THE LIGHTS A LITTLE SO WE CAN SEE THE SLIDES NICER. NEEDLESS TO SAY IT PROBABLY WOULDN'T MATTER WHAT COUNCIL SOFT WHAT INSTITUTE I WOULD COME SPEAK TO THERE WOULD BE AN AGREEMENT FOR THAT COUNCIL AND THAT FIELD OF STUDY THAT THE LARGEST BOTTLENECK IN BIOMEDICAL RESEARCH NOW -- AND YOU CAN REALLY PICK YOUR DATA-RELATED METAPHOR -- IS EITHER THAT WE'RE TRYING TO DRINK WATER OUT OF A FIRE HOST OR WHETHER IT'S A TSUNAMI OF DATA OVERWHELMING US. THERE HAS BEEN A SUBSTANTIAL CHANGE IN BIOMEDICAL RESEARCH AS EXEMPLIFIED BY COVER STORIED IN JOURNALS LIKE SCIENCE AND NATURE WHERE ONCE UPON A TIME THE BIG DATA SCIENCES JUST WERE IN THINGS LIKE ASTRONOMY, CLIMBOLOGY, PART L PHYSICS AND SO FORTH. ALL THE SUDDEN BIOMEDICAL RESEARCH HAS FOUND THE WAY TO THE GROAN-UP'S TABLE IN TERMS OF BIG DATA. THE TROUBLE ISN'T IN GENERATING THE DATA BUT IN ANALYZING, ASSIMILATING AND SO FORTH THESE MASSIVE DATA SETS WE'RE NOW ABLE TO GENERATE. LET ME BE CLEAR IS THAT WHILE YOU HEARD FROM ALAN'S INTRODUCTION I'M A GENOMICS GUY, STARTING JUST ABOUT THE TIME OF THE GENOME PROJECT AND CLEARLY IN MANY DAYS GENOMIC DATA HAS BECOME THE POSTER CHILD FOR THE BIG DATA CHALLENGES IN BIOMEDICAL RESEARCH, BY NO MEANS IS THE BIG DATA PROBLEM IN BIO MEDICINE COFINED TO THIS. INCREASINGLY, WE SHOULD RECOGNIZE THE REMARKABLE ADVANCES THAT HAVE TAKEN PLACE IN IMAGING TECHNOLOGY WHETHER CELLAR, TISSUE, THAT ARE RESULTING IN THE GENERATION OF VERY LARGE AMOUNTS OF IMAGING DATA. INCREASINGLY I'M SURE OF INSTITUTE, FPHENOTYPIC DATA BEING COLLECTED. WE'LL SEE MASS CUMULATION OF EXPOSURE DATA AND WE'RE ALL INTERESTED IN MINING THE RICH DATA THAT RESIDES OUT THERE IN ELECTRONIC HEALTH RECORDS. TO REALLY THINK ABOUT IT, IF YOU LOOK ACROSS THESE DIFFERENT DATA TYPES AND THINK ABOUT TECHNOLOGY ADVANCES IN PARTICULAR IN GENOMICS AND EVEN PHENOTYPES, VUK TIMES OF OUR OWN SUCCESS. WE DEVELOPED BETTER TECHNOLOGIES AND ALL SUDDEN WE FIND OURSELVES WITH THE NEXT BOTTLENECK AND THAT'S DATA ANALYSIS. I WILL ALSO POINT OUT THAT THIS IS NOT A TRANSIENT PROBLEM. THIS IS THE NEW REALITY FOR BIOMEDICAL RESEARCH. WE WILL NOW FOR ALWAYS, I THINK, BE A BIG DATA ENTERPRISE AND WITH SUCH A LONG TERM RECOGNITION OF THE PROBLEM, WE NEEDED A A SUBSTANTIAL ATTACK OF THIS PROBLEM AND THINK ABOUT THE SOLUTIONS NOT IN THE SHORT TERM BUT REALLY IN THE LONG TERM. WELL, MANY OF US AT NIH, MANY OF YOU RECOGNIZE THIS AS A A PENDING CHALLENGE, UM, AND THAN CLOUDED THE NIH DIRECTOR WHO WAS HEARING FROM LOTS OF US FOR MANY YEARS ABOUT THIS PROBLEM AND HE RECOGNIZED THIS AND SO IN EARLY 2011, HE APPOINTED A WORKING GROUP OF HIS OWN ADVISORY COMMITTEE TO THE DIRECTOR TO STUDY THIS PROBLEM. IT WAS A GROUP COCHAIRED BY DAVID DUMETS OF UNIVERSITY OF WISCONSIN AND LARRY TABAK AND IT HAD AN ALL-STAR CAST OF DATA SCIENCE EXPERTS FROM DIFFERENT AREAS WORKED HARD FOR THE BETTER PART OF A YEAR-AND-A-HALF OR SO AND THEN IN JUNE OF 201, REALLY JUST ABOUT ALMOST A YEAR AGO DELIVERED IN THIS ROOM I CAN REMEMBER AT THE JUNE 2012 MEETING OF THE ACD, CAME THEIR REPORT OF THIS DATA WORKING GROUP WHICH CALLED FOR A NUMBER OF MAJOR RECOMMENDATIONS FOR NIH TO ACT ON. THAT'S WHEY WANT TO TELL YOU ABOUT TODAY BUT LET ME START BY GIVING YOU OVERARCHING THEMES FROM THIS WORKING GROUP. THE REPORT BASICALLY GAVE IT VERY CLEAR WHEY JUST SAID IS THAT WE'RE IN A A PIVOTAL POINT WHERE WE RISK FAILING TO CAPITALIZE ON THESE REMARKABLE TECHNOLOGICAL ADVANCES IF WE DON'T DO SOMETHING. ONE MEMBER SAID RIGHT NOW WE'RE BORDERING ON THE INSTITUTIONAL MALPRACTICE BY NOT ACT K AGGRESSIVELY ENOUGH TO RECOGNIZE THE CHALLENGES AHEAD OF US BECAUSE OF BIG DATA. IT'S NOT JUST A MATTER OF BUYING A BUNCH OF COMPUTERS. NOT JUST A MATTER OF TRAINING A LOT OF NEW SCIENTISTS, MANY ELEMENTS OF THE RECOMMENDATIONS THAT BUBBLED OUT OF THIS WORKING GROUP INCLUDED MAJOR CULTURAL CHANGES THAT WERE GOING TO BE MADE, EVEN THE WAY WE THINK ABOUT VALUE OF DATA AND SHARING AND SO FORTH THAT WE ALSO NEEDED TO ATTACK THESE CULTURAL CHALLENGES AS WELL. AND REALLY, OVERALL WE AIM TO DEVELOP NEW OPPORTUNITY FOR SHARING DATA, FOR ANALYZING DATA, AND FOR INTEGRATING DATA AND EVERYONE OF THESE THINGS ARE OBSTACLES IN THE WAY THAT NEED TO BE ADDRESSED. THIS NEEDS TO BE A A LONG-TERM COMMITMENT, WE NEED TO THINK AS IN NIH ABOUT HOW WE NEED TO BE DOING THIS FOR THE NEXT DECADE AND BEYOND THAT WE'RE GOING TO NEED SUBSTANTIAL INVESTMENTS BEYOND THE INITIAL ONES I'M ABOUT TO DESCRIBE TO YOU. I ALSO WANT TO POINT OUT THAT THIS IS NOT JUST FOR SOME INSTITUTES, AND I WANT TO READ YOU ONE QUOTE FROM THE WORKING GROUPS REPORT. THEY POINT OUT THAT A FINAL KEY STRATEGIC CHALLENGE IS TO ENSURE THAT THE NIH CULTURE CHANGES ARE COMMISERATE WITH THE KEY ROLE OF INFORMATICS AND COMPUTATION FOR EVERY IC INSTITUTE'S AND MISSION. INFORMATICS SHOULD NOT BE CHAMPIONED BY JUST A A FEW ICs -- INSTEAD MUST ACCEPT A DISTRIBUTED COMMITMENT TO THE USE OF ADVANCED COMPUTATION AND INFORMATICS... WITH THAT AS A BACKDROP LET ME TELL YOU PROBLEMS IDENTIFIED THAT NEEDED TO BE ADDRESS BID THAT WORKING GROUP REPORT. THERE WERE PROBLEMS ASSOCIATED WITH LOCATING THE DATA, ACCESSING DATA, RELATED TO POLICIES AND PRACTICING FOR DATA SHARING, PROBLEMS WITH ORGANIZING MANAGING AND PROCESSING, DEVELOPING NEW METHODS FOR ANALYZING AND TRAINING RESEARCHERS. IT'S THOSE KINDS OF PROBLEMS THAT NEED TO BE SOLVED THAT WERE THEN PUT INTO THE HANDS OF THE NIH LEADERSHIP, LITERALLY ONE YEAR AGO AND THEN IT'S NOT TO SAY THAT WE WEREN'T ANTICIPATING THOSE RECOMMENDATIONS, AND IN FACT, FRANCIS COLLINS HAD ASKED MYSELF AND OTHERS AT THE NIH LEADERSHIP LEVEL TO PREPARE OURSELVES. WE HAD VARIOUS PROGRAM DIRECTORS FROM MANY INSTITUTES ALREADY WORKING BEHIND THE SCENES IMAGINING WHAT THE RECOMMENDATIONS WOULD BE SO THAT WHEN THEY HANDED US THAT BATON WE WOULD ALREADY BE RUNNING TO SOME EXTENT AND THAT'S WHAT'S HAPPENED. FRANCIS ASKED US TO MOVE QUICKLY ON THOSE RECOMMENDATIONS. WHAT I'M HERE TO TELL YOU TODAY IS BREAKING NEWS OF WHAT'S HAPPENING. IT IS HAPPENING FAST AND FURIOUS BECAUSE OF THE RECOGNITION THAT THIS IS IMPORTANT. COMING OUT OF THOSE RECOMMENDATIONS, NIH IS TACKLING THE BIG DATA PROBLEM AND THERE'S THREE MAJOR ELEMENTS OF THIS AND THE THIRD OF WHICH IS ACTUALLY GOING TO INVOLVE GRANTS AND FUNDING OPPORTUNITIES UH BUT THE FIRST TWO OF WHICH IS VERY MUCH P AN CONSTITUTIONAL COMMITMENT TO READY NIH FOR THIS NEW WORLD AND RECOGNIZE THAT THE NEW WORLD IS HERE TO STAY. SO THE THREE ELEMENTS ARE AS FOLLOWS AND I'LL TELL YOU DETAILS ABOUT EACH BUT FIRST INTRODUCE THEM. FIRST IS THE CREATION OF A NEW LEADERSHIP POSITION IN NIH CALLED AN ASSOCIATE DIRECTOR FOR DATA SCIENCE OR ADDS. THERE'S ALSO A NEW GOVERNING BODY WITHIN THE NIH CALLED A SCIENTIFIC DATA COUNCIL WHO'S JOB IT WILL BE TO PERMANENTLY BE LOOKING AT THESE ISSUES AND MAKING SURE NIH IS ON THE RIGHT TRACK. FINALLY, A NEW STRATEGIC INITIATIVE THAT WILL INVOLVE FUNDING OPPORTUNITIES, SOMETHING CALLED BIG DATA TO KNOWLEDGE. YOU CAN SEE FROM THIS DIAGRAM THEY ALL ENTER RELATE AND YOU'LL SEE FROM THE FOLLOWING SLIDES THAT ALL THREE OF THESE THINGS ARE VERY IMPORTANT FOR TO BE ABLE TO SEE THIS VISION COME TO REALITY. SO LET ME START WITH -- I'M GOING TO TALK ABOUT THEM IN THAT ORDER STARTING WITH THE ASSOCIATE DIRECTOR FOR DATA SCIENCE. I WILL POINT OUT WHAT'S IN A NAME AND LOTS OF NAMES WERE FLOATED AROUND EVEN ABOUT HOW TO NAME THAT POSITION BECAUSE THERE'S SO MANY THINGS WE'RE TALKING ABOUT HERE AND EACH OF THEM HAVE THEIR OWN JARGON NAMES OR FUN NAMES OR SERIOUS NAMES BUT WHAT WE'RE TALKING ABOUT SHEER BIG DATA BUT ALSO BIOINFORMATICS, COMPUTATIONAL BIOLOGY AND INFORMATION SCIENCE AND BIOSTATISTICS AND QUANTITY DAY TI BIOLOGY. AT THE END OF THE DAY WE JUST RESINATED WITH THE TERM DATA SCIENCE. PERHAPS WE WERE SLIGHTLY INFLUENCED BY AN ARTICLE THAT CAME OUT ABOUT THAT TIME BECAUSE WHEN YOU'RE IN DOUBT ON HOW TO NAME THING NEW, YOU SHOULD GO WITH SEXY AND WE HAD SEEN THIS ARTICLE IN THE HARVARD BUSINESS REVIEW THAT SAYS DATA SCIENTISTS IS THE SEXIEST JOB OF THE 21st CENTURY. [LAUGHTER] THE ARTICLE SHOWED HOW DATA SCIENCE IT WAS CENTER OF THIS UNIVERSE THAT EVERYTHING FROM DATA ENGINEERING AND SO FORTH AND IT JUST SEEMED TO BE A A GOOD NAME. THIS ACTUALLY THE CREATION OF THAT NAME ASSOCIATED WITH THE NEW LEADERSHIP POSITION ACTUALLY PREDATED THIS ARTICLE THAT CAME OUT IN NATURE THIS YEAR TALKING ABOUT A VISION FOR DATA SCIENCE AND IN FACT TALKED ABOUT HOW ALL THESE BIG DATA CHALLENGES REALLY NEED TO BE ADDRESSED BY ALMOST A NEW FIELD OF STUDY THAT FOCUSES ON DATA SO WE'RE GLAD WE WENT WITH THIS NAME AND IT IS STICKING, BUT AGAIN IT REALLY ENCOMPASSES ALL THOSE OTHER NAMES I SHOWED YOU ON THE PREVIOUS SLIDE. SO THIS NEW POSITION, ASSOCIATE DIRECTOR FOR DATA SCIENCE, THIS IS GOING TO BE THE CZAR. THIS IS THE POINT PERSON. THIS IS A POSITIONAL REPORT TO THE NIH DIRECTOR. I REALLY WANT TO EMPHASIZE, SUCH POSITIONS DON'T GET CREATED EVERY YEAR NECESSARY EVEN EVERY FEW YEARS. THEY TRY TO KEEP THE NUMBER OF INDIVIDUALS REPORTING TO THE DIRECTOR SMALL. FRANCIS SAW THIS AS CRITICALLY IMPORTANT TO NIH AND FIELD THIS INDIVIDUAL SHOULD REPORT DIRECTLY TO HIM. ALAN GUTTMACHER AND I HAVE MANY THINGS IN COMMON AND ONE OF THEM IS WE DON'T EVER SAY NO TO FRANCIS AND SO FRANCIS ASKED ME TO BE THE ACTING INTERIM FOR THIS SO I SAID YES BUT I ALSO SAID YES WITH THE AGREEMENT THAT I COULD COCHAIR SO I COULD FIND SOMEONE WHO COULD DO IT. JIM AROUNDSON AND I ARE THE COSHARE CHAIRS OF THIS COMMITTEE AND I'LL TELL YOU MORE ABOUT THAT IN A A SECOND BUT THAT SEARCH IS OFF AND RUNNING. P WHAT ARE THE RESPONSIBILITIES OF THIS NEW POSITION? THIS WILL BE THE PRINCIPLE ADVISOR TO THE NIH DIRECTOR AND TO THE ENTIRE NIH LEADERSHIP IN THE AREA OF DATA SCIENCE. THIS PERSON NEEDS TO BE VISIONARY AND A LEADER TO REALLY HELP NIH LEAD IN THE AREA -- FIRST CATCH UP AND THEN LEAD. THIS INDIVIDUAL WILL CHAIR THIS NEW DATA COUNCIL I'LL TELL YOU ABOUT, AND THIS ENDS UP BEING THE CHIEF STEWARD OF THE RESPONSIBILITIES I'M GOING TO TELL YOU ABOUT WITH THIS NEW DATA COUNCIL. THIS PERSON WILL BE THE PROGRAM LEAD FOR THIS INITIATIVE CALLED BIG DATA TO KNOWLEDGE, BUT ALSO THIS PERSON NEEDS TO COORDINATE DATA SCIENCE ACTIVITIES BOTHEN IN AND OUTSIDE THE NIH AND THERE ARE MANY GROUPS BOTH IN THE GOVERNMENT AND OUTSIDE THE GOVERNMENT THAT ARE TACKLING BIG DATA, WE NEED TO COORDINATE WITH THEM BETTER AND THERE NEEDS TO BE A POINT PERSON AT NIH THAT GOES OUTSIDE NIH TO COME AND TALK AND KNOW THERE'S AN INDIVIDUAL TALKING ON BEHALF OF NIH. THIS INDIVIDUAL NEEDS TO LEAD LONG TERM STRATEGIC PLANNING IN SCIENCE. WE DON'T HAVE IT RIGHT NOW AND IT'S GOING TO MORPH OVER TIME. THIS PERSON NEEDS TO ALSO BE RESPONSIBLE FOR PROMOTING TRANS-NIH NATIONAL AND GLOBAL POLICIES FOR DATA SHARING BECAUSE DATA SHARING IS A KEY COMPONENT OF WHAT NEEDS TO HAPPEN IN THE COMING YEARS. FINALLY, THIS PERSON NEEDS TO COORDINATE WITH THE NIH CHIEF INFORMATION OFFICER REALLY WORRIES ABOUT HERE ON CAMPUS ACTIVITIES AROUND INFORMATION TECHNOLOGY AND IS REALLY VIEWED THAT THIS POSITION IS COMPLEMENTARY IN MANY WAYS THINKING ABOUT THE BROAD BIOMEDICAL RESEARCH COMMUNITY JUST LIKE THE CHIEF INFORMATION OFFICER HERE THINKS ABOUT THE ON-CAMPUS INFORMATION TECHNOLOGY ISSUES SO THERE WILL BE A LOT OF SYNERGY JIS BETWEEN THAT INDIVIDUAL AND THIS INDIVIDUAL. THIS IS THE AD WE HAD OUT. THE INITIAL APPLICATIONS WERE DUE IN THE MIDDLE OF MAY. THE SEARCH COMMITTEE IS VERY ACTIVE. WE'RE ABOUT TO START THE KEY PHASE OF INTERVIEWING CANDIDATES BUT THIS IS A "OPEN UNTIL FILLED POSITION" WHICH MEANS AT ANY TIME WE COULD TAKE NEW APPLICATIONS AND CONSIDER THEM. IF YOU THINK OF SOMEONE WHO WOULD BE A GREAT PERSON FOR THIS JOB, SEND ME THEIR NAME BECAUSE WE HAVE NO IDEA HOW LONG THIS SEARCH L TAKE BEFORE WE FILL IT AND WE WILL BE TAKING APPLICATIONS IN REAL TIME UNTIL THAT POSITION IS FILLED. THIS IS GOING TO BE A HARD POSITION. THIS IS A COORDINATING POSITION, NOT A POSITION LIKE RUNNING AN INSTITUTE OR A CENTER. THIS IS GOING TO BE VERY MUCH ABOUT SOMEBODY THAT COULD BE VERY GOOD AT GETTING GROUPS WORKING TOGETHER AND BEING VERY STRATEGIC AT A TRANS-NIH LEVEL SO I CAN'T HELP BUT SHOW YOU THIS ONE MEASURE OF SUCCESS AND I STEAL THIS FROM KATHY HUDSON BUT VERY MUCH THIS IS WHAT I THINK ABOUT THIS POSITION. NOW HAVING BEEN ACTING IN IT FOR A NUMBER OF MONTHS IT'S GOING TO BE LIKE HERDING CATS, THERE'S DEFINITELY NO QUESTION IN THAT ONE OF THE THINGS WE'RE LOOKING FOR IN A CANDIDATE THAT WILL GET THIS JOB PERMANENTLY. THAT'S THE FIRST ELEMENT ASSOCIATE DIRECTOR FOR DATA SCIENCE THE SECOND IS NEW GROUP WHICH IS GOING TO BE A HIGH LEVEL NIH GROUP THAT WILL BE CHAIRED BY THE DIRECTOR OF THIS GROUP. INDIVIDUALS VERY HIGH UP IN THE NIH ORGANIZATION WHO CAN REALLY THEN THINK VERY BROADLY ALMOST LIKE COUNCIL SERVES A ROLE, THIS IS GOING TO BE A GOVERNING GROUP FOR ALL THESE ACTIVITIES AND WE NEED TO HAVE HIGH-LEVEL THOUGHTFUL INDIVIDUAL THAT CAN REPRESENT ACROSS NIH ALL OF THE DIFFERENT INTERESTS. THIS SCIENTIFIC COUNCIL WILL REPORT TO THE NIH STEERING COMMITTEE, THE GROUP THAT IS RIGHT UNDER FRANCIS THAT HAS A LOT OF DECISION AUTHORITIES. AGAIN T GROUP HAS TRANS-NIH REPRESENTATION IMPORTANTLY SO THAT ALL INTERESTS ARE REPRESENTED. IT'S RESPONSIBILITIES, WELL, YOU MIGHT IMAGINE, WORKING HAND IN HAND WITH THE ASSOCIATE DIRECTOR FOR DATA SCIENCE THEY'LL BE INVOLVED IN TRANS-NIH PROGRAMMATIC LEADERSHIP AND COORDINATION OF DATA SCIENCE ACTIVITIES. THEY WILL OVERSEE E THIS BIG DATA TO KNOWLEDGE INITIATIVE I'M ABOUT TO TELL YOU ABOUT. WE HOPE THIS GROUP CAN HELP BE THE TRANS-NIH INTELLECTUAL PROGRAMMATIC HUB FOR DATA SCIENCE. SERVE AS SORT OF A COORDINATING CONVENING FUNCTION. ONE OF THE WORKING GROUP REALIZED WAS THERE WERE POCKETS OF FANTASTIC DATA SCIENCE ACTIVITIES GOING ON IN INDIVIDUAL INSTITUTES AND CENTERS ACROSS THE 27 CENTERS. THEY DIDN'T REALLY KNOW WHAT WAS HAPPENING AND THEY WERE ACTUALLY DUPLICATING EFFORTS IN SOME CASES. NOW WE'LL HAVE A STANDING GROUP THAT WILL BE ABLE TO DO VARIOUS THINGS TO TRY TO GET THESE DIFFERENT ACTIVITIES A LITTLE BETTER COORDINATED AND MAKE SURE WE'RE AWARE OF IT AND WHEN THERE'S OPPORTUNITIES FOR THEM TO COME TOGETHER TO BETTER MAKE NEW INITIATIVES HAPPEN. IN A SIMILAR WAY THIS GROUP WILL COORDINATE DATA SCIENCE ACTIVITIES BEYOND THE NIH RECOGNIZING THAT THERE'S MANY ACTIVITIES OUTSIDE OTHER GOVERNMENT AGENCIES, PRIVATE SECTORS AND INTERNATIONAL IN SCOPE. THE LONG-TERM I REALLY WANT TO KEEP STRESSING, WE ARE NOT DONE WITH THE PLANNING A AND THIS BODY WILL BE THE ENTITY WORKING WITH THE ASSOCIATE DIRECTOR FOR DATA SCIENCE TO DO LONG TERM PLANNING IN THE AREA AND A ALSO HAVE A MAJOR ROLE IN THINKING ABOUT POLICY DEVELOPMENT AND OVERSIGHT AROUND DATA SHARING. SOMETHING THAT IS COMING TO MATURATION FOR GENOMIC DATA BUT WE NEED TO GO BEYOND THAT AND THINK ABOUT OTHER DATA TYPES AND MAKING YOUR POLICIES ARE IMPLEMENTED AND APPROPRIATE OVERSIGHT PROVIDED. LASTLY, THERE'S ALSO AN ADMINISTRATIVE DATA COUNCIL THAT IN PARALLEL HAS BEEN ESTABLISHED TO DEAL WITH A LOT OF ON-CAMPUS ADMINISTRATIVE DATA IN JUST MAKING SURE THESE TWO GROUPS ARE TALKING WITH ONE ANOTHER. FINALLY, LET ME TELL YOU ABOUT THE PROGRAMMATIC HUB OR THE PROGRAMMATIC FEATURE OF EVERYTHING I'M DRIEPING AND THAT'S THIS INITIATIVE CALLED BIG DATA TO KNOWLEDGE OR BD 2 K. EVERYTHING I'M ABOUT TO DESCRIBE IS MEANT TO AUGMENT THE ACTIVITIES GOING ON AT MANY INSTITUTES AND CENTERS, NOT MEANT TO REPLACE THEM. WE WILL NOT REDUCE OUR INVESTMENT IN BIOINFORMATICS DATA SCIENCE AT MY INSTITUTE BECAUSE OF THIS. WE'LL CONTINUE TO INVEST AT A SIMILAR LEVEL, PROBABLY WILL ACTUALLY INCREASE IT WE'LL JUST MAKE SURE WE COORDINATE WITH BD 2 K. THIS IS GOING BE A MAJOR TRANS-NIH INITIATIVE THAT ADDRESSES AN NIH IMPERATIVE AND KEY ROADBLOCK ASSOCIATED WITH BIG DATA. IF I HAD A SUMMARIZE IN ONE SENTENCE WHAT'S THE OVERARCHING GOAL, I WOULD SAY THAT BY THE END OF THIS DECADE TO ENABLE A QUANTUM LEAP IN THE ENTERPRISE TO MAXIMIZE VALUE OF GLOWING VOLUME AND XOM PLEXTY OF BIOMEDICAL DATA. WE ARE FOLLOWING THE GENERAL RECOMMENDATIONS OF THE WORKING GROUP THAT THERE WERE FOUR MAJOR PROGRAMMATIC AREAS WE NEEDED INVESTMENT IN AND I'M NOT GOING TO DESCRIBE THEM IN DETAIL, BUT JUST SO UH YOU REALIZE WHAT THESE FOUR AREAS ARE, ALL OF WHICH WILL BE ASSOCIATED WITH OR FUNDING OPPORTUNITIES IN THE COMING YEAR AND ALL OF WHICH YOU'LL BE HEARING MORE ABOUT BUT JUST IN A NUTSHELL FIRST AREA OF FACILITATING BROAD USE OF BIOMEDICAL BIG DATA. BETTER WAYS TO INDEX, SITE DATA, TO KNOW IT'S OUT THERE AND USABLE BY A MUCH LARGER SET OF THE COMMUNITY. SECONDARY IS DEVELOPING AND DISSEMINATING METHODS, ANALYSIS AND SOFTWARE FOR DATA. MAKING SPECIALIZED SOFTWARE AVAILABLE TO EVERYBODY. SO THAT INDIVIDUAL INVESTIGATE TOFRS OUTSIDE THE FIELD COULD USE THEM PRODUCT TIFFLY FOR THEIR STUDIES. OF COURSE, WE HAVE MAJOR ISSUES WITH ENHANCING TRAINING IN BIOMEDICAL BIG DATA WHETHER IT'S THE NEXT GENERATION OR CURRENT GENERATION. DATA SCIENCE HAS MOVED MUCH FASTER. THERE ARE MANY PEOPLE IN MID CAREER WHO NEED TO BE BETTER ABLE TO DEAL WITH BIG DATA IN THINKING ABOUT HOW TO GIVE THEM TRAINING OPPORTUNITIES TO ENHANCE THEIR RESEARCH PROGRAM AND SEN THEN THINKING ABOUT THE GRADUATE STUDENTS, POST DOCS, MEDICAL STUDENTS AND OTHER STUDENTS IN VARIOUS HEALTH CARE DELIVER SECTORS THINKING ABOUT HOW TO TRAIN THEM BROADLY FOR DEALING WITH THE NEW REALITY OF BIG DATA. FINALLY WHAT H WILL BE THE CENTERPIECE OF THIS PROGRAM, THERE WILL BE A CENTERS OF EXCELLENCE PROGRAM THAT WILL BE CREATED. THESE CENTERS WILL TACKLE INDIVIDUAL PROBLEMS THAT ARE ARE EITHER IDENTIFIED BY NIH -- WE NEED THIS, WE NEED THAT -- BUT ALSO WILL BE A LOT OF CENTERS CREATE WRD WE WANT INVESTIGATORS BRENGING USED INS ON WHAT IS NEEDED TO BE ABLE TO TACKLE THE BIG DATA PROBLEM. SO THERE'LL BE A MIXTURE. IN TERMS OF DETAILS I I WANT TO PROVIDE YOU. YOU MAY SAY HOW CAN YOU START A NEW INITIATIVE WITH ALL THESE BUDGETARY CONSTRAINTS? IT'S REMARKABLE THAT WE'RE ABLE TO. LY TELL YOU IN THE COURSE OF THE LAST YEAR OR SO, EVEN BEFORE THEN, I'VE STOOD THAT PODIUM BOTH IN FRONT OF ADVISORY GROUP BUT ALSO THE INSTITUTE DIRECTORS AND WE KNEW THIS WAS GOING TO REQUIRE SOME MONEY COMING UP AND YET THERE'S BEEN NO RESISTANCE. EVERY INSTITUTE AND CENTER DIRECTOR RECOGNIZED SOMETHING WAS NEEDED HERE. PROBABLY NEEDED TO CREATE A SOLUTION. THIS IS A CREATIVE SOLUTION IN A MODEL THAT'S REALLY NEVER BEEN TRIED BEFORE THAT'S A PILOT BUT I AM VERY OPTIMISTIC IS GOING TO WORK. IN TERMS OF OVERSIGHT T COUNCIL IS GOING TO PROVIDE THE OVERSIGHT FOR THIS. WE NOW HAVE A PLAN IN PLACE TO FUND BD 2 K FOR THE NEXT SEVEN YEARS OR SO, NOT TO SAY IT WOULD END THEN. THE FUND WILLING BEGIN NEXT FISCAL YEAR, ANY MONEY BEING SPENT THIS FISCAL YEAR IS ALL AROUND PLANNING WORKSHOPS AND SO FORTH. THIS WILL RAMP TO SLIGHTLY OVER A HUNDRED MILLION DOLLARS BY THE YEAR FISCAL 2017. THE NOVELTY HERE IS FUNDING MODEL. INSTITUTES DON'T HAVE A LOT OF MONEY AND SO THERE'S GOING TO BE FRONT LOADING CONTRIBUTION BIS THE COMMON FUND. THIS TIME, THE COMMON FUND'S NOT GOING RUN THIS PROJECT THEY'RE JUST A MAJOR PROJECT IN THIS AND THEY'RE GOING TO FRONT LOAD THE MONEY BUT ALSO FROM THE BEGINNING AT A SMALL AMOUNT INITIALLY AND LARGE AMOUNT OVER TIME THERE WILL BE CONTRIBUTIONS FROM EVERY SINGLE INSTITUTE AND CENTER PROPORTIONATE TO THE SIZE OF THAT INSTITUTE AND IMPORTANTLY T IDEA IS THAT THE COMMON FUND MONEY WILL TAPER OFF BETWEEN NOW AND 2020. THE INSTITUTE CENTER'S CONTRIBUTIONS WILL INCREASE BETWEEN NOW AND 20 AND 20 SO THAT BY 2020 THE INSTITUTES WILL OWN THE INITIATIVE COMPLETELY AND THE IDEA IS TO MAKE THE INSTITUTES AND CENTERS TAKE OWNERSHIP OF THIS BECAUSE A A COMMON FUND PROJECT CAN'T GO ON FOREVER. SO THIS IS A NEW MODEL, NEVER BEEN TRIED QUITE THIS WAY. HAVING A FUNDING PLAN OF JOINT FUNDING BUT THEN A KNOWN FORMULA WHEREBY THE COMMON FUND WOULD BE BACK AND INSTITUTES AND CENTERS WILL BE STEPPING FORWARD. WHAT'S THE MAJOR THINGS HAPPENING NOW IN THIS AREA IS THAT THERE ARE GOING TO BE OVERTHE NEXT YEAR OR SO WORKSHOPS IN EACH OF THESE AREAS BECAUSE WE NEED TO REFINE SOME OF THESE BEFORE WE ACTUALLY PUT OUT FUNDING ANNOUNCEMENTS. THIS IS THE MAJOR ACTIVITY THAT'S TAKING PLACE. I'M JUST GOING TO SHOW THESE AND NOT REALLY READ THEM. IN THE FIRST AREA THERE ARE ALREADY THREE WORKSHOPS BEING PLANNED THAT WILL HELP US ARE REFINE EXACTLY WHAT NEEDS TO BE DONE IN THE AREA OF BROAD USE OF BIG DATA. SEVERAL WORKSHOPS, ONE THAT IS PLANNED THE OTHER WE DON'T KNOW THE DATE QUITE YET AROUND SOFTWARE PROGRAMMATIC AREA, AROUND TRAINING THERE'S A WORKSHOP NEXT MONTH TO REFINE OUR IDEAS BEFORE PUTTING OUT FUNDING ANNOUNCEMENTS AND THEN WE ALREADY HAVE ONE BUT I'M SURE WILL BE MULTIPLE WORKSHOPS AROUND THE CENTERS PROGRAM. WINDING DOWN JUST IN TERMS OF SOME UPDATES THAT'S HAPPENED OF LATE JUST TO KEEP YOU SORT OF CONTEMPORARY VIEW OF WHERE WE ARE, AGAIN, RIGHT NOW THERE'S GOING BE A SERIES OF WORKSHOPS BEGINNING THIS SUMMER AND THE REAL FUNDING FOR THIS, THE FIRST INITIATIVES WILL BE FUNDED IN FISCAL YEAR 2014. THERE IS STRONG SUPPORT ACROSS NIH AS I SAID WHERE EVERY INSTITUTE AND CENTER ARE WILLING TO PROHIBIT FUNDS TO THIS AND SIMILARLY WE'VE HAD TO PUT TOGETHER A WORKING GROUP TO MAKE SURE WE CAN ACCOMMODATE ALL THE PROGRAMMATIC ACTIVITIES THAT HAVE TO BE DEVELOPED. I SENT OUT AN E-MAIL TO EVERY DIRECTOR AND SAID COULD YOU .1 OR TWO PEOPLE TO THIS WORKING GROUP? ALMOST EVERY INSTITUTE AND CENTER DIRECTOR SENT US LIKE FOUR AND FIVE NAMES SO WE HAVE A WORKING GROUP OF 125 PEOPLE THAT MARK GIRE IS SPEAR HEADING THIS WORKING GROUP. HE HAS AN EXECUTIVE COMMITTEE AND HE'S BROKEN DOWN THIS COMMITTEE INTO SUBGROUPS BUT I WANT TO POINT OUT WE ALREADY HAVE 24 INSTITUTES AND CENTERS AND SEVERAL OFFICES ACROSS NIH ACTIVELY INVOLVED IN THESE VARIOUS WORKING GROUP ACTIVITIES TO SHOW THE LEVEL OF COMMITMENT ACROSS NIH. SEQUESTRATION HAS TAKEN A LITTLE BIT OF WIND OUT OF OUR SAILS. OUR AMBITION PLAN WAS IN WHITE BUT WE HAD TO REVISE IT A LITTLE BIT BECAUSE COMMON FUNDS COULDN'T QUITE CONTRIBUTE AS MUCH AS INITIALLY THOUGHT SO WE'RE GETTING A SMALLER START UP IF YOU SEE WHEREAS NEXT YEAR WE'LL HAVE FUNDING AROUND $27 MILLION AND BY FISCAL 17 WE EXPECT IT TO CROSS THE HUNDRED MILLION DOLLARS THRESHOLD. LASTLY I WANT TO EMPHASIZE THAT THIS IS NOT SOME LITTLE GROUP DOING ALL THIS WORK BUT THE DESIGN OF THIS IS TO HAVE ITS GOVERNANCE INTEGRATED WITH THE IMPORTANT GOVERNANCE OF THE NIH. YOU CAN SEE HOW THE ASSOCIATE DIRECTOR HAS VOICE ON THE STEERING COMMITTEE. AMONG THE SCIENTIFIC DATA COUNCIL RESPONSIBILITY BD 2 K IS ONE OF THEM BUT IN THIG LONG TERM, YOU CAN IMAGINE OTHER SUBGROUPS SPINNING OFF THAT'LL REPORT UP THROUGH THE SCIENTIFIC DATA COUNCIL. ZEL THE ATTENTION ON AN ON GANG BASIS OF THE STEERING COMMITTEE AND ALSO THE DIRECTOR. SO IN CLOSING LET ME TELL YOU THAT TO SUMMARIZE THAT I THINK THE BIOMEDICAL RESEARCH ENTERPRISE IS UNDERGOING A MAJOR PHASE CHANGE WITH RESPECT TO DATA AND DATA SCIENCE. WE REALLY NEED A TRANS-NIH SOLUTION TO THESE TRANS-NIH PROBLEMS AND I THINK WE HAVE IT AND THESE SOLUTIONS INCLUDE ALTHOUGH I DIDN'T DISCUSS THEM IN GREAT DETAIL NOT JUST PUTTING OUT FUNDING ANNOUNCEMENTS BUT LOTS OF CULTURAL CHANGES THAT ARE GOING BE REQUIRED BUT I REALLY DO THINK THAT THESE NEW NIH PLANS I'VE DESCRIBED TO YOU THEY'RE CRITICAL. I ALSO WANT TO REALLY EMPHASIZE THAT I CONSIDER THEM TRANSITIONAL. I THINK WHAT WE'RE TALKING ABOUT NOW IS JUST FOR THE NEXT HANDFUL OF YEARS AND I THINK THERE WILL BE A LONGER TERM COMMITMENT THAT'LL BE NEEDED BY THE END OF THE DECADE. I DON'T KNOW WHAT THAT LOOKS LIKE. IT MIGHT REQUIRE STRUCTURAL CHANGES, MAYBE JUST FUNDING BUT WE'LL LEARN A A LOT BETWEEN NOW AND 2020 AND THAT'LL SERVE AS INCREDIBLE TESTING GROUND FOR WHAT NEEDS TO GO ON BEYOND THAT. THANK YOU FOR YOUR ATTENTION, I'M HAPPY TO TAKE ANY QUESTIONS. >> THANK YOU VERY MUCH, ERIC. IT'S A WONDERFUL INTRODUCTION. I THINK TO OVERSIMPLIFY THIS IN A WAY. THE HISTORY OF SCIENTIFIC DISCOVERY HAS BEEN UNTIL VERY RECENTLY ONE OF AMASSING DATA. THAT REMAINS CRUCIAL TO WHAT WE DO, BUT IN SOME WAYS THE BIGGEST CHALLENGE AND SOME WAYS BIGGEST OPPORTUNITY NOW IS WHAT DO WE DO WITH THE DATA? THE FACT THAT NIH IS ELECTING TO TAKE THIS ON IN SOME WAYS A BOLD WAY THAT'S A FAIR BIT OF MONEY, IT'S A LOT OF ACTIVITY, LOTS OF FOLKS INVOLVED, BUT AGAIN THE FACT THAT JUST OUT OF THE GATE BEFORE PEOPLE EVEN HAVE A CHANCE TO RESPOND TOE-MAILS THERE ARE 24 OF THE 27 ICs INVOLVED AND IT'S A NEW YEAR AND SO WE WANT TO MAKE SURE THAT WE DON'T, YOU KNOW TAKE TOO LONG DOING THAT. SOME WOULD SAY WE ALREADY HAVE. I THINK WE'RE TRYING TO MOVE IT RAPIDLY TO TAKE CARE OF IT AND I REALLY APPRECIATE ERIC STEPPING IN TO BE THE ACTING DIRECTOR OF THIS AND NOT JUST SORT OF TWID LING HIS THUMBS BUT MAKING SURE WE MOVE FORWARD WITH THIS AND GET IT WELL SET UP. WHOEVER THIS PERSON IS AND I WOULD AGAIN JUST RATIFY ERIC'S DECLARATION THAT WE'RE INTERESTED IN GETTING A REALLY SUPERB PERSON FOR SOMEONE WHO WANTS TO HAVE AN IMPRINT ON THE FUTURE DISCOVERY. THIS IS GOING TO BE A COORDINATING FUNCTION AS WELL SO SOMEBODY WITH PEOPLE SKILLS, THE CHARISMA, WHATEVER IT IS TO GET OTHER PEOPLE TO BE HERDED WILL BE AN IMPORTANT PART OF THIS. SO YOU CAN THINK OF FOLKS FOR THAT, PLEASE LET US KNOW, BUT QUESTIONS, THOUGHTS THAT ERIC SHOULD BE THINKING ABOUT, ETC. ? >> I'VE HAD EXPERIENCE THROUGH IOM TRYING TO DEAL WITH OTHER LARGE GOVERNMENT CLINICAL DATA SETS THAT ARE FAR BEYOND YOUR PER VIEW BUT IT MAKES ME THINK THAT THERE'S POTENTIALLY -- I WANT TO KNOW KIND OF SORT OF THE NEXT LEVEL UP OF COORDINATION ARE YOU GOING TO SIT ON A SECRETARY'S GROUP THAT'S TRYING TO FIX THE CLINICAL RECORDS, LET ALONE THE V.A. AND DOD AND EVERYBODY ELSE. >> SURE WE'LL -- [LAUGHTER] >> [INDISCERNIBLE]. >> WHAT I WILL TELL YOU IS FROM THE DAY THAT FRANCIS ANNOUNCED THAT I WAS ACTING ASSOCIATE DIRECTOR, THOSE KINDS OF GROUPS NOW FIND ME. I CAN'T SOLVE THEIR PROBLEMS IMMEDIATELY, BUT IT INSTANTLY ILLUSTRATED THIS IDEA THAT WE NEEDED A POINT PERSON AND WE ARE GETTING MUCH MORE INTEGRATED IN CONVERSATION, CERTAINLY WITH THE IOM ON MULTIPLE LEVELS BUT WITH OTHER PARTS OF THE GOVERNMENT, AND YOU KNOW THIS IS HERCULEAN CHALLENGES BUT WHAT'S IMPORTANT IS WE'LL FINALLY AT B AT THE TABLE FOR SOME OF THESE DISCUSSIONS AND ALSO AS WE FORMULATE IN THE FOUR PROGRAMMATIC AREAS, ALSO THINKING ABOUT HOW WE CAN ALSO SOLVE OUR PROBLEMS BUT HOW THESE COULD QUICKLY SOLVE SOME BROADER PROBLEMS. >> SO I'M WONDERING, YOU KNOW, AS YOU'RE SAYING THIS IS REALLY EVOLVING INTO A SCIENCE-BASED [INDISCERNIBLE]. >> MM-HMM. >> WHERE DO YOU SEE THE NEXT GENERATION BRINGING THEM ALONG? I KNOW YOU HAVE ONE HERE THAT YOU'RE GOING TO BE TAKING CARE OF THE RESEARCH, PER SE, BUT IT SEEM LIKE THERE SHOULD BE A CAW DRA OF PEOPLE. >> GREAT QUESTION. I DON'T WANT TO GET AHEAD OF ORANGE WORKSHOP AND THAT'S ONE OF THE REASONS WHY THAT'S ONE OF THE FIRST WORKSHOPS WE'RE HAVING. FROM THE DISCUSSIONS WE'VE HAD WHATEVER WE DO IN TRAINING, IT'S GOING TO BE MULTIPLE COMPONENTS. CERTAINLY ON THE ONE HAND WE SAY WE WANT TO DEVELOP A WHOLE NEW GENERATION OF TRUE DATA SCIENTISTS THAT WHEN THEIR Ph.D. IS WHATEVER WORD THEY USE BUT THAT'S WHAT THEY DO. THEY ARE ABSOLUTELY COMPLETE PROFESSIONALS, EXPERT IN THIS AREA, SIMILARLY YOU MIGHT ARGUE THAT ONE MIGHT IMAGINE THAT ANYBODY GETTING A Ph.D. IN THE UNITED STATES SHOULD HAVE COMPETENCIES IN SOME AREAS, WHAT'S THE BEST WAY TO DO THAT? SORT OF SOME MINIMUM COMPETENCIES IN DATA SCIENCE. THEN IT'S NOT A FARFETCHED IDEA TO START TO THINK ABOUT OTHER PROFESSIONAL GROUPS AND WHAT WE CAN WE DO TO RAISE THE -- AS I MENTIONED EARLIER, LET'S NOT FORGET ABOUT MY GENERATION. ALL MY SCIENTIFIC COLLEAGUES OUT THERE, THEY'RE SUFFERING BECAUSE THIS HAS HAPPENED SO FAST AND THEY'RE TWID LING AWAY IN THE LABORATORY AND THEY ARE FEELING THEIR INABILITY TO UTILIZE DATA SETS THAT ARE OUT THERE, OTHER THINGS WE CAN DO TO HELP RAISE THEIR GAME FOR THE LAST 20 30 YEARS OF THEIR CAREER. WE NEED TO BE THIG ABOUT ALL THESE THINGS. >> ONE MORE QUESTION. >> I'M CURIOUS IT'S BEEN MY IMFLAEGS SOME OF THE EUROPEAN COUNTRIES ARE AHEAD OF US IN HAVING MORE INTEGRATED CLINICAL DATA SETS ON THEIR POPULATION AND THE EPIDEMIOLOGIST LIKE THEM, ARE YOU TAKING ADVANTAGE OF EXPERTISE IN THOSE COUNTRIES AND IS IT TRUE THAT THEY'RE AHEAD OF US? >> YOU KNOW AHEAD OF US IN SOME DIMENSIONS AND I THINK IT'S ARGUABLE, LOTS OF ARGUMENTS ABOUT WHETHER THEY'RE COMPLETELY AHEAD OF US IN ALL WAYS AND SOME CASES RELATES TO THE SOCIAL ASPECTS OF THEIR MEDICAL CARE DELIVERY SYSTEMS SO THAT PROVIDES OPPORTUNITIES THAT WE SIMPLY DON'T HAVE HERE, BUT WITHOUT QUESTION, I MEAN I COULD ALSO TELL YOU THAT QUESTION AGAIN THE ABILITY TO INTERACT WITH THOSE GROUPS AND NOW HAVING INTERACTIONS IN A VERY ORGANIZED WAY. I WAS AT A CONFERENCE THE END OF LAST YEAR AT OXFORD THAT BROUGHT SOME OF THESE IDEAS TOGETHER. THE INTERNATIONAL EFFORTS IN BIG DATA ARE ARE GROWING TOO. WE WANT TO BE PART OF THOSE GROUPS AS WELL AND THIS WILL PROVIDE AN OPPORTUNITY TO DO THAT. >> THANK YOU VERY MUCH, ERIC. OBVIOUSLY THIS TOPIC AT LARGE WE'LL BE TALKING ABOUT PROBABLY AT EVERY SINGLE COUNCIL SESSION UNTIL THE 300th COUNCIL MEETING I SUSPECT SO THANK YOU FOR HELPING INTRODUCE THIS TO US, ETC. THOSE PAYING PARTICULAR ATTENTION TO [INDISCERNIBLE] LITTLE BIT OUT OF ORDER. WE WERE GOING TO CONCEPT CLEARANCE SESSION EARLIER BUT BECAUSE OF FOLKS' SCHEDULES WE HAVE SHIFTED THIS WAY. P WHAT WE'RE GOING TO DO NOW IS TO TALK ABOUT SOME INTERESTING SCIENCE AND THEN WE WILL DO THE CONCEPT CLEARANCES BEFORE WE BREAK FOR LUNCH SO TRY TO DO THE NEXT SESSION SO THAT -- ACTUALLY THAT'S NOT THE NEXT PRESENTATION. SO THE NEXT SESSION IS GOING TO BE ABOUT THE SUPPORT TRIAL. MANY OF YOU HAVE HEARD ABOUT THE SUPPORT TRIAL. WE KNEW THAT WE'D HEARD FROM COUNCIL THAT VARIOUS FOLKS SAYING GEE YOU'RE IN THE NICHD COUNCIL OVER THE LAST COUPLE OF MONTH I KEEP HEARING ABOUT THE SUPPORT TRIAL; WHAT IS IT? WE THOUGHT WE MIGHT BE ABLE TO ARM YOU CAN INFORMATION SO WHEN PEOPLE ARE ASKING YOU THOSE THINGS YOU'D BE ABLE TO ANSWER IT. WE THOUGHT IT WAS FASCINATING SCIENCE AND IT HAS COME TO SOME FAIR BIT OF ATTENTION LATELY SO WE E HAVE THREE SPEAKERS FOR THIS SESSION. THE FIRST IS GOING TO BE ROSE HIGGINS WHO'S GOING TO TALK TO US, SET THE TABLE IN SOME WAYS BY TALKING ABOUT THE NEONATAL RESEARCH NETWORK. AND THEN WALLY CA ARE RLO WHO IS THE PI FOR THE SUPPORT TRIAL HAS BEEN NICE ENOUGH TO COME FROM ALABAMA TO JOIN US FOR THIS SESSION TO REALLY TALK ABOUT THE SCIENCES. WE WANTED YOU TO REALLY UNDERSTAND THE SCIENCE OF BOTH NEONATAL RESEARCH NETWORK AND SUPPORT. AND THEN I WILL BE THE THIRD SPEAKER TO TALK SOMETHING ABOUT SOME OF THE POLICY IMPLICATIONS AND SOME OF THE POLICY BRU-HA-HA. THIS GOT A LOT OF ATTENTION A FEW YEARS AGO, BUT IT'S GOTTEN SOME LATER ATTENTION, NOTORIETY WHATEVER SO I'LL TALK ABOUT THAT AND OBVIOUSLY WE'LL TALK WITH ALL OF YOU ABOUT ANY ASPECTS OF THAT. BUT WE WANT TO FOCUS ON THE SCIENCE PARTICULARLY SO THAT YOU UNDERSTAND THE CONTRIBUTION THAT SUPPORT TRIAL HAS VERY IMPORTANTLY MADE SO UNDERSTANDING OF THE CARE OF PREMATURE INFANTS. SO ROSE, THANK YOU FOR ALL YOU'VE DONE REGARDING THIS, BUT FOR THE UPCOMING PRESENTATION AS WELL. >> YEAH. THANK YOU. I'D LIKE TO THANK NICHD AND THE COUNCIL FOR ALLOWING THIS. WHAT I'M GOING TO DO IS TALK ABOUT THE SUPPORT TRIAL BUT FIRST .GIF A LITTLE BACKGROUND ON THE NEONATAL ARE RESEARCH NETWORK. THE NETWORK'S MISSION IS TO DESIGN AND CONDUCT STUDIES TO LOOK AT SAFETY AND EFFICACY FOR TREATMENT AND MANAGEMENT STRATEGIES FOR THE CARE OF NEWBORN INFANTS. P THE NETWORK WAS SET UP BECAUSE BACK IN THE EARLY TO MID 1980s, MANY PEOPLE IN NEONATOLOGY WERE DOING STUDIES WHERE THEY LOOKED AT THEIR UNITS, THEY DID A MANAGEMENT CHANGE PRESENTED IT AT A MEETING AND IT BECAME ADOPTED IN PRACTICE WITHOUT GOOD RIGOR IN CLINICAL TRIALS. THIS NETWORK WAS ESTABLISHED IN 1986 TO ADDRESS THE NEED FOR WELL-DESIGNED CLINICAL TRIALS AND STUDIES IN NEONATAL MEDICINE. OUR GOALS INCLUDE TO IDENTIFY PRIORITY ISSUES FOR RESEARCH, TO PROMOTE INFANT HEALTH AND PREVENT DISEASE AND TO LOOK AT INTERVENTIONS FOR SAFETY, EFFICACY AND COST EFFECTIVENESS. AND INCLUDING TRANSLATIONAL RESEARCH, GENETICS AND NEW TECHNOLOGIES. SO THE NRN IS A COLLABORATIVE PARTICIPATION ON COMMON PROTOCOLS. IT'S FUNDED BY COOPERATIVE AGREEMENTS. THEY ARE COMPETITIVELY PEER REVIEWED IN AN OPEN COMPETITION THAT'S BASED ON THE CONTENT OF THE GRANT, CONTENT PROPOSAL, DEPARTMENT OF FACULTY AND INSTITUTION. REALLY THE ABILITY TO RECRUIT, ARE RETAIN, AND FOLLOW UP PATIENTS. GRANTS ARE GIVEN A PRIORITY SCORE AND THERE NEEDS TO BE DIVERSITY IN THE POPULATION AND JUST BECAUSE SOMEBODY'S IN THE NETWORK TODAY DOESN'T MEAN THEY'RE GOING TO BE IN, IN THE NEXT CYCLE, THEY REALLY NEED TO PERFORM WELL. HERE ARE THE CURRENT NETWORK CENTERS IN THE CURRENT CYCLE AND YOU CAN SEE THEY'RE ALL OVER THE COUNTRY. HERE, THIS SLIDE IS VERY BUSY. THESE ARE THE NRN PROTOCOLS THAT HAVE BEEN ACCOMPLISHED SINCE INCEPTION AND YOU CAN SEE THERE'S MANY OF THEM. YOU'RE NOT MEANT TO READ ALL OF THEM, IT'S JUST TO SHOW WHAT'S BEEN OUT THERE. HERE IS OUR NRN PUBLICATION GRAPH THAT'S SHOWN AT EVERY MEETING AND WE'RE UP TO 269 PEER REVIEWED PUBLICATIONS, 17 OF WHICH HAVE APPEARED IN THE NEW ENGLAND JOURNAL AND FOUR IN JAMMA. HERE'S SOME OF THE COMP BUGSS THAT HAVE BEEN HIGHLIGHTED OVER THE LAST 10-15 YEARS. I DIDN'T GO ALL THE WAY BACK BUT YOU CAN SEE THE IMPACT ON CLINICAL PRACTICE, MANY OF OUR PUBLICATIONS APPEAR IN AAP, ACOG, CDC PUBLICATIONS. THESE ARE ON PARRY VIABILITY, NEW OWE DEVELOPMENTAL OUTCOME. THERE'S A PARRY VIABILITY WEB-BASED OUTCOME TOOL THAT'S ONE OF THE MOST LARGELY USED THING WHERE IS WE HAVE FROM OUR NETWORK WHERE YOU CAN GO IN FOR A THREATENED 22-25 WEEK GESTATION AND LOOK AT NETWORK OUTCOMES BOTH THE HOSPITAL OUTCOMES FOR SURVIVAL AND THEN NEURODEVELOPMENTAL OUTCOMES JUST BEFORE TWO YEARS OF AGE. ADDITIONALLY, MANY OTHER STATEMENTS INCLUDING LEVELS OF NEONATAL CARE, FOLLOW UP OF HIGH RISK INFANTS, ANTENATAL STERER ROADS AS WELL AS BREAST FEEDING. WE HAVE A VERY LARGE CON LOM RATE OF CONTRIBUTIONS. I ONLY HIGHLIGHT RECENT OF THESE. -- VITAMIN A FOR PREVENTION OF BPD, WHOLE BODY COOLING FOR INRECEIVE LOP THY --. THE LATEST SIMILAR KNOLL CONTRIBUTIONS THAT OUR NETWORK HAS COME FROM THE SUPPORT STUDY. JUST SOME BACKGROUND. WHEN THE SUPPORT STUDY WAS ORIGINALLY DESIGNED, WE HAD A COUPLE OF QUESTIONS. HOW DO YOU BEST ASSIST BREATHING AFTER DELIVERY OF AN EXTREMELY PREMATURE INFANT. SURFACTANT IS PROBABLY ONE OF THE BEST STUDIED NEONATAL DRUGS OUT THERE BUT YOU NEED A TUBE IN PLACE IN THE BABY'S WINDPIPE. SURFACTANT STUDIES ALSO PREDATED -- THESE WERE LARGELY DONE IN THE MID TO LATE 1980s. THE ANTENATAL CORTICOSTEROID STATEMENT WAS PUBLISHED IN 1995. THE QUESTION WAS, DO UH YOU STILL NEED SURFACTANT IN THE FACE OF ANTENATAL STEROIDS? THERE WERE MANY SUPPORTS OF CONTINUE POSITIVE AIRWAY -- THE SECOND QUESTION THE SUPPORT STUDY ADDRESSED WAS WHERE DO YOUR TARGET OXYGEN SATURATION? HIGHER LEVELS LEAD TO HIGHER RET NOP THINK AND LUNG DISEASE. THE NEONATAL PRACTICE WHEN THIS TRIAL GOT DEVELOPED AND STARTED WAS THERE WAS A TREND TOWARD MORE USE OF C PAPS. THERE WAS ATS ALSO TRENDS TOWARD LOWER OXYGEN SATURATION TARGETS. THERE WERE PUBLISHED REPORTS OF SATURATIONS IN THE 1980s TARGET AND SOME AS LOW AS 70 THAT LOWERED ROP WHICH CAN LEAD TO BLINDNESS AND HAD NO EFFECT ON MORTALITY. THE STATE OF THE SCIENCE WAS 24-27 WEEK INFANTS HAD OXYGEN SATURATION TRTHS 85-95% OF THIS TIME. WHERE DO YOU BEST FINE TUNE THAT RANGE? THE OVERALL LEVEL OF OXYGEN TARGETING SATURATION WAS NOT CHANGED IN THE SUPPORT TRIAL. WHAT WE DID WAS TARGET TWO RANGES HERE, 85-89 -- THERE WAS NO SUGGEST TO INCREASE AT THE OUTSET OF THIS STUDY USING THIS SATURATION RANGE. THE REAL QUESTION WAS, WHERE DO YOU KEEP IT FOR OPTIMAL OUTCOME? WHAT'S BETTER, EARLY SURFACTANT OR C PAP? SO IF WE LOOK AT OUR SUPPORT TIMELINE, THIS PROTOCOL DEVELOPMENT OCCURRED IN 2003 AND 2004. WE HAD A VERY LARGE SITE TRAINING IN 2004. WE DEMANDED EVERY SIGHT HAVE THEIR PI AND OTHERS THERE. WE FINALIZED OUR FORMS AND THE FIRST INFANT WAS ENROLLED IN FEBRUARY OF 2005. ENROLLMENT SPANNED UNTIL 2009. WE HIT A SNAG IN NOVEMBER 2005. THE LEAD INVESTIGATORS WERE CONCERNED, WANTED TO LOOK AT THE DATA. IT WAS RECOMMENDED THAT STEPS BE TAKEN TO TARGET THIS AND THE TRIAL WAS HALTED TEMPORARILY AND THEN REE RESUMED IN 2006. LAST INFANT ENROLLED IN FEBRUARY 2009 AND THE 18-MONTH FOLLOW-UP STARTED MID TRIAL TO GET OUTCOME ON THE BABIES. IT'S GREAT IF YOU HAVE SOMETHING THAT WORKS WELL BUT YOU A ALSO WANT TO SEE HOW IT AFFECTS LONGER TERM OUTCOME AT TWO YEARS. OUR PAPERS WERE PRESENTED AT PEDIATRIC ACADEMIC SOCIETY AND IN CONJUNCTION WITH THE AMERICAN THORACIC SOCIETY WE HAD TWO EARLY RELEASE NEW ENGLAND JOURNAL PAPERS. THE FOLLOW-UP PAPER WAS THEN PUBLISHED IN DECEMBER OF THIS LAST YEAR IN 2012 AND AS MANY OF YOU KNOW, THERE WAS AN OHRP LETTER THAT WAS ISSUED IN MARCH OF 2013 AND MY SLIDE ISN'T TOTALLY UP TO DATE. THERE WAS ANOTHER LETTER ISSUES ON JUNE 4TH AND MORE PUBLICITY WITH THIS. SO OUR STUDY RESULTS, WE HAVE IN HOSPITAL STUDY RESULTS AND FOLLOW-UP OUTCOMES AT 18-22 MONTHS AND I'M GOING TO HAND THIS OVER TO DR. CARLO TO PRESENT. AND HERE WERE THE CENTERS THAT PARTICIPATED. THEY DID A HUGE EFFORT TO GET THIS STUDY DONE. I'LL TURN IT OVER TO WALLY NOW. [WHISPER]. >> THANK YOU ROSE, AND THANKS DR. GUTTMACHER FOR OPPORTUNITY TO PRESENT HERE. I WANT TO ALSO ACKNOWLEDGE THAT THE NICHD AND [INDISCERNIBLE] FUNDED THIS TRIAL. THIS IS A EXTREMELY PRETERM BABY. THERE ARE ABOUT 50,000 OF THESE BORN IN THE U.S. EVERY YEAR. ABOUT 1% OF THEM BECOME BLIND, 10% OF SERIOUSLY HANDICAPPED LONG TERM, 20% DIE. SO THESE ARE VERY HIGH-RISK POPULATION. GIVE YOU BACKGROUND. IN THE 40s, OXYGEN BECAME AVAILABLE IN THE INCUBATORS SO BABIES WOULD GET UNCONTROLLED OXYGEN SUPPLEMENTATION. IN THE 50s ROP WAS BECAME AN EPIDEMIC AND TRIALS IN THE 50s RESTRICTED OXYGEN BUT IN AN UNCONTROLLED FASHION ALSO SO THEY WOULD NOT ALLOW MORE OXYGEN [INDISCERNIBLE] 50%. THIS LED TO A REVIEWS IN ROP, THEY DID NOT FOLLOW THE BABIES FOR BLINDNESS, BUT THEY REPORTED SOME OF THE [INDISCERNIBLE] REPORT SOME INCREASE IN MORTALITY [INDISCERNIBLE]. IN THE 60 O s THERE WAS AN OXYGEN RESTRICTION THAT WAS RESULT IN 16 DEATHS PER FOR CASE OF BLINDNESS PREVENTED. 50 YEARS LATE IN 2010 WAS THE FIRST RANDOMIZED CONTROL TRIAL OF OXYGEN TARGETING THROUGHOUT THE HOSPITALIZATION IN NEO-NATES. IN 2013 THE [INDISCERNIBLE] TRIALS CONFIRMED THE SUPPORT RESULTS. TO GIVE YOU BACKGROUND AND THEN I'LL GO INTO THE ARK TRIAL. THERE HAS NOT BEEN A CONSENSUS ON OXYGEN [INDISCERNIBLE] TARGETS ACCEPTABLE LEVELS WERE INITIALLY THOUGHT TO BE 88, 98 THEN WERE BROUGHT OUT TO 85, 95. THERE WAS NO STANDARD EVIDENCE OR PROCESS THAT NEED OF OXYGEN SUPPLEMENTATION. DOESN'T MATTER. IT WAS UNCLEAR TO WHAT DEGREE IT MATTER TARGETING SATURATION IN AND OUT OF RANGE, THERE HAD BEEN PREVIOUS TRIALS, THE BOOST TRIAL THAT I WILL MENTION FIRST. THIS [INDISCERNIBLE] TRIAL WAS A I ASSIGNED TO TAKE BABIES WHO HAD [INDISCERNIBLE] AND SATURATE THEM IN HIGH 90s VERSUS LOW 90s ESSENTIALLY AND THEY LOOK AT PRESSURE ROP BECAUSE THERE WAS SOME ANIMAL DATA. AFTER THEY WERE DEVELOPING ROP, YOU COULD HAVE GIVEN THEM MORE OXYGEN AND THEY WOULD PREVENT [INDISCERNIBLE]. I APOLOGIZE FOR THE SLIDE HERE. THEY FOUND THAT THRESHOLD ROP WAS SIGNIFICANTLY REDUCED FROM 48-41%, BUT THIS RESULTED ALSO IN [INDISCERNIBLE] HOSPITALIZATION, [INDISCERNIBLE] OXYGEN SUPPLEMENTATION AND PROLONGED -- I APOLOGIZE FOR THE SLIDE HERE. YOU CAN SEE A GOOD RANDOMIZED TO HIGH 90s HAD WORSE OUTCOMES PULMONARY OUTCOMES AND EVEN THOUGH THERE WAS A BENEFIT IN THRESHOLD ROP THERE WAS NO FOLLOW-UP ON THESE INFANTS FOR BLINDNESS, REALLY, AND THIS PRACTICE WAS NOT USED OR WAS [INDISCERNIBLE] ESSENTIALLY. THE PRACTICE OF GIVING MORE OXYGEN. ANOTHER TRIAL IS SIMILAR DESIGN IN BABIES WHO ALREADY WERE OLDER BABIES AT THE NICU TO LOOK AT GROWTH AND DEVELOPMENT BECAUSE OF COMMON PRACTICE OF GIVING THEM MORE OXYGEN TO IMPROVE THEIR GROWTH OR DEVELOPMENT AND WHAT THEY FOUND THAT THERE WAS NO ADVANTAGE IN DEVELOPMENTAL OUTCOME OR GROWTH AND ACTUALLY IT INCREASED DEATH IN THE HIGH SATURATION GROUP. OXYGEN SUPPLEMENTATION AT 36 WEEKS WAS WORST AND OXYGEN AT [INDISCERNIBLE] WAS WORSE. SO [INDISCERNIBLE] HIGH 690 OF THE INTERVENTION GROUP. BOTH REPORTED PULMONARY HARMS. SATURATIONS IN THE HIGH 90s WHERE IT GRADUALLY DISAPPEARED. WHAT HAPPENED THEN WAS HOW ABOUT WHERE DO WE TARGET SATURATIONS? DO WE GO BELOW 90%? BEFORE SUPPORT THERE WERE NO RANDOMIZED CONTROL TRIALS LOOKING AT SATURATION TARGETS BELOW 90%. THERE WERE RETRO SPECULATIVE STUDIES. THIS WAS A RETROSPECULATIVE STUDY, A POPULATION-BASED STUDY DONE IN ENGLAND OF ALL INFANTS LESS THAN 28 WEEKS. SEVERAL REFERRAL UNITS AND THEY ANALYZE THE DATA BY UNIT INTENDING ON WHAT SATURATION TARGETS THEY AIM FOR. AFTER THE RESULTS OF THIS STUDY UNITS WERE CLASSIFIED BY FOUR SATURATION OF TARGETS USING THOSE UNITS, UNITS DOWN TO 70, 90, 95, ALMOST THE SAME AND 88, 98 WHICH WAS THE INITIAL AS I HAD MENTIONED INITIAL PRACTICE. WHAT THEY FOUND AT THAT THESE CENTERS THAT USE THE LOWEST SATURATION TARGETS OF 70-90% HAD THE LOWEST THRESHOLD ROP, NO INCREASING [INDISCERNIBLE] AND THIS ARRIVAL WAS [INDISCERNIBLE] OTHER CENTERS. THIS WAS REALLY INTERESTING AND [INDISCERNIBLE] TARGETS AS LOW AT 70% AS ROSE MENTIONED. ONE SINGLE CENTER STUDY IN THE U.S., THEY SHOW HOW YOU COULD REDUCE ROP TREATMENT, SURGERY. IN THE DARK IS UNIT IN CALIFORNIA HERE, ALMOST ELIMINATING LACER FOR ROP COMPARED TO THE REST OF THE U.S. HERE [INDISCERNIBLE] NETWORK. THIS PIGMENT OF TARGETING BELOW 90 SEEM TO BE QUITE BENEFICIAL FOR ROP. THIS IS STAGE THREE OR FOUR ROP. REDUCTION IN ALMOST AN INITIAL BLINDNESS AND LOTS REDUCTION IN ROP. I SHOULD MENTION THAT ALSO OTHER STUDIES AT THIS AND OTHER STUDIES ESPECIALLY THE TEEN TRIAL SHOWED THAT YOU COULD REE DEUCE BY AT LEAST 50% THE NUMBER OF [INDISCERNIBLE] VENTILATORS BY AT LEAST 50% [INDISCERNIBLE] BY TARGETING SATURATION BELOW 90% WHICH WAS INTERESTING AND REMARKABLE AS AN INTERVENTION. THIS WAS FOUND NOT IN NONE OF THE STUDIES DID THEY FIND ANY EVIDENCE OF INCREASING MORTALITY WHICH IS INTERESTING. SO WHAT WAS PHYSICIANS TARGETING AT THAT TIME? IN THE SURVEY OF THE [INDISCERNIBLE] THIS IS A LARGE GROUP OF CENTERS [INDISCERNIBLE] IN THE WORLD AND ORGANIZATION OF [INDISCERNIBLE] SATURATION TARGETS WERE USUALLY HIGHER THAN 90, HIGHER THAN 88 AS YOU CAN SEE HERE. MOST OF THE PROGRAMS USE HIGH SATURATION TARGETS. WHEN THEY USE HIGH TARGETS, THEY ALSO -- THIS SHOWN ALSO HERE, THIS IS SIMILAR STUDY PUBLISHED A FEW YEARS BEFORE '97, A HUNDRED UNITS IN THE U.S. SATURATION TARGETS OF 88 UP TO 95 AND THE MAXIMUM TARGET WERE USUALLY QUITE HIGH, IN FACT 100% SATURATIONS WERE FREQUENTLY ACCEPTED AND 95 WAS FREQUENTLY AN UPPER LIMIT. MANY CENTERS DID NOT USE ALARMS OR HIGH ALARMS AS YOU CAN SEE HERE. CENTERS HAD ALARM SET AT 100% WHICH MEANT THEY WERE NOT PREVENTING HYPER OXIA. WHILE THERE WERE MANY DIFFERENT PRACTICES IT WAS USUALLY TENDED TO USE HIGH SATURATION TARGETS THAT MAY HAVE BEEN HARMFUL TO PATIENTS. THERE WAS A STUDY OBSERVATION DONE IN THE U.S. JUST AROUND THE TIME SUPPORT WAS STARTING IN WHICH THEY ANALYZED PATIENTS PROSPECTIVELY PREEMIES OF SEE SATURATION TARGETS WERE ACTUALLY BEING ACHIEVED. THESE WERE INFANTS ABOUT THE SAME SIZE OF THE SUPPORT BABIES [INDISCERNIBLE] 26-WEEKERS. CENTERS WERE USING MOSTLY SATURATION TARGETS OF 91/95 [INDISCERNIBLE]. FEWER CENTERS USED THE LOWER SATURATION TARGETS. SOME CENTER INCLUDED BOTH TARGETS, SOME CENTERS NEITHER WHICH MEANT THEY WERE REALLY IN THE MIDDLE OF THE PACK. THESE ARE SATURATION TARGETS THAT WERE BEING USED. YOU CAN SEE THAT THEY CLOSER MOST WE HAVE OF 88%. HOW ABOUT SATURATIONS ACHIEVED? IF YOU LOOK AT SATURATIONS ACHIEVED, THEY WERE MUCH HIGHER. AS YOU CAN SEE MOST OF THE SATURATIONS WERE ABOVE 92%. PHYSICIANS WERE ACTUALLY TARGETING -- HIGHER SATURATIONS THAN THOSE TARGETS, AND IF YOU LOOK AT THE RESULTS OF THAT [INDISCERNIBLE] WITHIN INTENDED RANGE OF SATURATIONS TARGETED, ONLY 48% OF THE TIME SATURATIONS WERE ACHIEVED AND THESE THE REALITY OF NEONATOLOGY, SATURATIONS ARE ALL OVER THE PLACE, GO UP AND DOWN AND IT'S HARD TO [INDISCERNIBLE] WITHIN THE PATIENTS. USUALLY SPE USUALLY SPENT ABOVE START. [INDISCERNIBLE] -- PRETERM BABIES WERE DEVELOPING BLINDNESS AND SATURATION TARGETS WERE NOT KNOWN BUT PHYSICIANS WERE USING LOWER AND LOWER SATURATION TARGETS SO WE DESIGNED THIS STUDY TO TEST IN THE EXTREMELY PRETERM INFANTS OF 24-27 WEEKS, A SATURATION TARGET OF 85, I THINK A RANGE OF 89 COMPARED TO 81-95 AS A CONTROL GROUP LOOKING AT COMBUSTED OUTCOME OF [INDISCERNIBLE] OR DEATH. INFANTS HAVE TO HAVE A DECISION FOR [INDISCERNIBLE] UPTAKE CONSENT. THE STUDY WAS DONE [INDISCERNIBLE] -- GET EQUAL POPULATIONS. WE USE TARGETS AS MENTIONED BEFORE AND WE USED [INDISCERNIBLE] MASK THE CLINICIANS SO WHILE THE DISPLAY SATURATIONS WERE THE SAME, THE PATIENTS ACTUALLY WERE IN THE TARGETS FOR EACH SPECIFIC GROUP AS SHOWN HERE. SO THE CLINICIANS WERE MASKED. THIS HAD BEEN DONE IN THE BOOST TRIAL NUMBER ONE IN A SIMILAR WAY, THUS YOU SEEN HIGHER SATURATIONS. THESE ALGORITHMS BASICALLY WE USE [INDISCERNIBLE] AT A STANDARD LEVEL PPZ THEY HAD [INDISCERNIBLE] OF THE BOOSTS, THE SUPPORT THAT BOOSTS TWO TRIAL AND THE [INDISCERNIBLE] TRIAL HERE'S THE CANADIAN TRIAL. THE BOOST TRIAL IS THREE TRIALS DONE IN UH NEW ZEALAND, AUSTRALIA AND THE U.K. AS YOU CAN SEE IN THE FIVE TRIALS IT WERE THE SAME WE ALL USE THE SAME DESIGN -- IS VERY DIFFERENT TO THE [INDISCERNIBLE] AND BOOST ONE TRIAL WHERE EXPERIMENT GROUPS HAD HIGHER SATURATION TARGETS. AND HERE ARE THE RESULTS OF THE STUDY. THESE ARE 1,300 PATIENTS WERE RANDOMIZED, THIRD ONE WAS ABOUT 800 GRAMS, 26 WEEKS. THEY WERE EQUALFULLY GREAT DISTRIBUTION AS [INDISCERNIBLE] MULTIPLE BIRTH WHICH ARE THE MAJOR PREDICTORS OF OUTCOME. THESE ARE THE DISTRIBUTION OF THE SATURATIONS A YOU CAN SEE THERE'S SOME OF OUR LAB. -- HIGHER THAN TARGETS AS IS KNOWN TO HAPPEN. YOU MAY THINK THIS OVERLAP IS TOO MUCH BUT ACTUALLY WE FOUND DIFFERENCES BETWEEN THE GROUPS. THIS TO SHOW THAT THERE'S SOME SEPARATION SO WHETHER YOU LOOK AT [INDISCERNIBLE] SATURATION RANGES HERE THERE'S SIGNIFICANT SEPARATION IN SATURATIONS AND THERE'S SIGNIFICANT DIFFERENCE IN EXPOSURE THESE PRESENTER OF TIME ON OXYGEN AND YOU CAN SEE THERE'S SEPARATION OF EXPOSURE TO OXYGEN. THESE THIS THE MAIN OUTCOME OF THE TRIAL; SEVERE ROP OR DEATH WAS NOT SIGNIFICANTLY DECREASED. THERE WAS A TIME FOR REDUCTION OF SEVERE ROP OR DEATH, BUT THIS WAS CONSTITUTED BY A SIGNIFICANT REDUCTION IN ROP WITH A SIGNIFICANT INCREASE IN DEATH IN THE EXPERIMENTAL GROUP. DEATH SEPARATED AFTER ABOUT A MONTH OF LIFE OR SO. SO IT TOOK A UH FEW DAYS IT WAS NONE OF THE PATIENTS DIED IMMEDIATELY AFTER EXPOSURE TO INTERVENTION. THE INFANTS HAVE BEEN FOLLOWED NOW TO TWO YEARS. THIS IS FOLLOW-UP COHORT, AND AS YOU CAN SEE HERE, THE PRIMARY OUTCOME WAS DETERMINED IN 94% OF THE SUBJECTS. DEATH [INDISCERNIBLE] DID NOT DIFFER BUT DEATH WAS SIGNIFICANTLY INCREASED IN THE LOWER SATURATION GROUP. NEW DEVELOPMENT AND IMPAIRMENT ABOUT 10% IN BOTH GROUPS. BLINDNESS DID NOT DIFFER -- IN SUMMARY OXYGEN SATURATION DID NOT AFFECT THE PRIMARY OUTCOME MEASURE BUT SIGNIFICANTLY AFFECTED ROP. THE MORTALITY AFFECT PERSISTED OF 18-22 MONTHS. WHEN WE COMPLETED THE SUPPORT TRIAL AND BEFORE PUBLICATION, WE ASKED PERMISSION TO THE NIH AND SHARED DATA WITH OTHER DAMON TORING COMMITTEES OF OTHER TRIALS. THIS IS A YEAR LATER, THE BOOST TRIA TRIALS IN Y U. K., NEW ZEALAND AND AUSTRALIA. THEY STOPPED ENROLLMENT, THEY NOTICE THAT PRETERM BABIES WHO WERE HAVING THEIR OXYGEN TARGETED IN SATURATION RATES 91-95 WERE SURVIVING MORE OFTEN THAN PRETERM BAY IS IS HAVING TARGETS OF 85-89. THEY STOPPED THIS IN A YEAR AFTER SUPPORT ENDED BECAUSE THEY THOUGHT THE RESULTS WERE DIFFERENT AND [INDISCERNIBLE]. THEY SAID THE DIFFERENCE SWOUZ CLEAR THAT IT WAS LIKELY TO CHANGE IF THE TRIAL CONTINUED TO THE END. AT THAT TIME THEY DECIDED THAT ENOUGH BABIES WOULD BE ENROLLED IN THE TRIAL AND BABIES IN THE TRIAL WOULD BE TREATED WITH HIGH SATURATION TARGETS. THE CUT TRIAL T CANADIAN TRIAL ALSO DONE IN MULTIPLE COUNTRIES THROUGHOUT THE WORLD, ACTUALLY CONTINUE THEIR ENROLLMENT UNTIL THEY FINISH COMPLETE ENROLLMENT BECAUSE THEY CLAIMED THERE WAS NO DIFFERENCE IN THEIR RESULTS. FROM THE BEGINNING AFTER SUPPORT WAS ASSIGNED WEED A GOT A GROUP OF INVESTIGATORS THROUGHOUT THE WORLD, SHARE OUR PROTOCOL, THEY COPIED OUR METHODS, OUR INTERVENTION, OUR OUTCOME MEASURES, AND WE DEVELOPED A PROSPECTIVE COLLABORATION FOR A PROSPECTIVE META-ANALYSIS. THIS IS RESULTS OF THE TRIALS PPZ THIS IS DEATH OF THE LATEST AGE. THE BOOSTING 3 TRIALS THEY HAVE REPORTED THAT THEY ARE TOGETHER IN [INDISCERNIBLE] MEDICINE. I HAVE INCLUDED THEM HERE AND THE [INDISCERNIBLE] TRIAL WAS JUST PUBLISHED IN GAMMA. THESE ARE THE RESULTS OF CONFIRMING THE RESULTS OF THE SUPPORT. THERE'S A SIGNIFICANT INCREASE IN MORTALITY IN THE LOWER SATURATION TARGETS. DETERMINE DETERMINE TO HARM WOULD BE 38. AFFECT SIZE A BIT SMALLER HERE DONE IN THE SUPPORT TRIAL BUT FOR EXAMPLE THE BOOST TRIAL HAD A A VERY LARGE EFFECT IN THE LATTER PART OF THIS STUDY. SO THIS HAS BEEN A VERY IMPORTANT STUDY. THREE NEW ENGLAND JOURNAL MEDICINE PAPERS HAVE RESULTED FROM THIS TRIAL. THERE HAS BEEN A LOT OF INTEREST IN THIS TOPIC AS EVIDENCED BY THE INTERNATIONAL COLLABORATION AS WELL AS THE OTHER TRIALS FUNDED BY ALL THEIR RESEARCH INSTITUTES IN THOSE COUNTRIES. SO THANK YOU FOR THE NIH SUPPORT AND I KNOW WE'VE BEEN CRITICIZED BY OHRP, BUT THE STUDY WAS VERY WELL DESIGNED. WE USED THE BEST DATA AVAILABLE. THERE WAS NO EVIDENCE OF INCREASED MORTALITY IN THIS SATURATION TARGETS, SO I FEEL CONFIDENT THAT OUR POSITION OF BEING ETHICAL AND CORRECT WOULD PREVAIL. THANK UH YOU VERY MUCH. [APPLAUSE] >> THANK YOU, WALLY. I'M GOING TO NOT TALK SO MUCH ABOUT THE SCIENCE BUT MORE ABOUT THE REACTION OF THE SCIENCE BUT SINCE ROSE WALLY REALLY LAID OUT THE SCIENCE I THOUGHT WE'D PAUSE AND SEE IF THERE ARE ANY QUESTIONS. I ALSO WANT TO ACKNOWLEDGE AS WE DID AT THE BEGINNING THAT NHLBI WERE PARTNERS IN SUPPORTING SUPPORT AND I'M GLAD TO SEE DEPUTY DIRECTOR WAS ABLE TO JOIN US FOR THIS PRESENTATION AND DISCUSSION. SO, AND JOSIE BRIGS THE DIRECTOR OF NCAMS HAS HAD AN ACTIVE ROLE AS AN ACTING PART OF THE TRANSITION IN NCATs ALSO A VERY ACTIVE ROLE OF THE ENTIRE CLINICAL RESEARCH COMMUNITY IS QUITE INTERESTED IN ALL OF THIS SO WE THANK BOTH OF YOU FOR BEING HERE FOR THIS. QUESTIONS FOR EITHER ROSE OR WALLY OR BOTH ABOUT THE SCIENCE? I THINK IT'S A PRETTY GOOD DESCRIPTION OF IT. WELL GOOD. WELL THEN YOU CAN ALSO ASK QUESTIONS LATER OF ALL OF US, BUT LET ME -- SO PROBABLY BECAUSE OF WHERE I TRAINED, UM, I WAS TAUGHT AS A MEDICAL STUDENT AND AS A HOUSE OFFICER THAT THE HIGHEST LEVEL OF PRESENTATION WAS TO QUOTE THIS WEEK'S NEW ENGLAND JOURNAL SO I DECIDED TO GIVE A TALK WHICH DOES NOTHING BUT QUOTE AN ARTICLE FROM THIS WEEK'S NEW ENGLAND JOURNAL. I FIGURED THIS IS THE EPITOME OF INTELLECTUAL SOMETHING OR OTHER. YOU HAVE THE ARTICLE IN FRONT OF YOU. IT'S A HANDOUT APPEARING LAST NIGHT IN THE ONLINE EDITION OF THE NEW ENGLAND JOURNAL WHERE TWO KIND OF IN SOME WAYS [INDISCERNIBLE] I CAN TELL YOU THEY WERE WRITTEN INDEPENDENTLY OF EACH OTHER. ONE AN ARTICLE BY KATHY HUDSON WHO IS A DEPUTY DIRECTOR AT THE NIF, MYSELF AND FRANCIS COLLINS THE DIRECTOR WHICH IS ENTITLED IN SUPPORT OF SU POR TI UH VIEW FROM THE NIH AND ANOTHER PIECE THAT'S WRITTEN BY 46 LEAD PEDIATRIC AND BIOETHICS SPECIALISTS FROM AROUND THE COUNTRY ABOUT THEIR VIEW OF THE SUPPORT TRIAL. BOTH OF THESE PUBLICATIONS CAME ABOUT, BUT OF COURSE AS WALLY JUST REFERRED TO OHRP BACK IN MARCH WROTE A LETTER TO WALLY AS THE PI TO UNIVERSITY OF ALABAMA, BIRMINGHAM CALLING INTO QUESTION SOME OF THE CONSENT PROCESS FOR THE SUPPORT TRIAL. IT GOT A LOT OF ATTENTION IN BOTH THE SCIENTIFIC AND LAY PRESS. THE REAL REASON WHY MY GRANDSON LOOKS SO BELITTLED BY THE NEW YORK TIMES BECAUSE THE EDITORIAL ON THIS SUBJECT WHICH BEWILDERED ME AS WELL I MUST ADMIT. AND WHAT HAPPENED SINCE THEN, I THINK COUNCIL MAY BE AWARE OF THIS, THERE WAS SOME QUESTIONING, I THINK OF THE NIH. AFTER ALL WE SUPPORTED THIS TRIAL, CAME OUT OF NEONATAL RESEARCH NETWORK, YET, WE WEREN'T SAYING VERY MUCH ABOUT THE CONDUCT OF THIS; WHY WAS THAT? THAT'S BECAUSE OHRP WHICH IT'S INTERESTING TO NOTE WAS ORIGINALLY PART OF NIH, BUT BECAUSE I THINK THERE ARE SOME APPROPRIATE CONCERN THAT THAT WAS KIND OF THE FOX LOOKING AFTER THE HEN HOUSE OR SOMETHING, THAT OHRP SHOULD BE SEPARATE FROM NIH AND GO WITHIN THE PRODUCT OF HEALTH AND HUMAN SERVICES SO IT'S A SISTER TO HEALTH AND HUMAN SERVICES, AND IT BECAME CLEAR THAT OHRP AND NIH IN WAYS I'LL DETAIL IN A MOMENT HAD DIFFERENT VIEWS OF THE CONDUCT OF THIS STUDY. HHS PROBABLY APPROPRIATELY SAID CAN'T WE GET TO SOME KIND OF ALIGNMENT WITHIN THE DEPARTMENT ABOUT THE CONDUCT OF THIS STUDY? AND I MUST STRESS, IMPORTANTLY WHAT IT SAYS ABOUT THE CONDUCT FOR ANY STUDY WITHIN THE STANDARD OF CARE BECAUSE THAT IS WHY THIS IS GETTING SO MUCH ATTENTION IN THE RESEARCH COMMUNITY. AND SO MANY, MANY E-MAILS, PHONE CALLS, ETC WENT ON. I SAID TO SOMEONE RECENTLY AND IT'S ONLY SLIGHT HYPERBOLE BUT I BELIEVE THERE MAY HAVE BEEN MORE E-MAILS ABOUT THIS PUBLICATION THAN ACTUALLY WORDS IN THE PUBLICATION. AT THE END OF THE DAY AS YOU'LL SEE, WHILE I WOULD SAY THAT THE FOLLOW-UP LETTER WHICH WAS ISSUED A COUPLE OF DAYS AGO BY OHRP PROBABLY NARROWS THE DIFFERENCES BETWEEN THE NIH AND THE OHRP VIEW OF THIS, DIFFERENCES REMAIN AND THE DEPARTMENT SAID, WELL, YOU'VE DONE A GOOD JOB, BOTH TRIED TO SEE HOW YOU CAN ALIGN YOUR VIEWS, SO IN ALL HONESTY, YOU SHOULD BOTH PUBLICLY STATE YOUR VIEWS SO WE WERE ALOUD TO HAVE THIS PUBLICATION IN THE NEW ENGLAND JOURNAL WHICH I'M HAPPY TO SEE HIT THE LIGHT OF DAY BEFORE THIS PRESENTATION TO UH YOU BECAUSE I WAS GOING TO MAKE THAT PRESENTATION ANYWAY. SO WHAT I'M GOING TO DO IS MORE OR LESS QUOTE JUST FOR THOSE DON'T HAVE IN FRONT OF YOU WHO HAVEN'T READ IT YET WHAT WE KIND OF SAY T KEY POINTS TO THE ARTICLE AND I APOLOGIZE THAT I'M GOING TO BREAK A RULE I HAVE OF NOT TENDING TO READ POWER POINT SLIDES, BUT I'M ESSENTIALLY GOING TO DO THIS JUST TO GET ACROSS WHAT WE THOUGHT AND THIS REALLY WAS AN ARTICLE THAT ALL THREE OF THE AUTHORS CONTRIBUTED TO THAT HAVE INTELLECTUAL OWNERSHIP OF. I MUST SAY THAT IN MANY, MANY DISCUSSIONS THAT WENT ON PRIMARILY BECAUSE OF ROSE'S ABILITY AS A TEACHER, FRANCIS COLLINS GOT SO RAPIDLY UP TO SNUFF ON THIS STUFF THAT AS I JOKED IN F MY GRANDSON HAD REQUIRED INK BASE I WOULD HAVE ALLOWED FRANCIS TO DO THE INK BASE BECAUSE HE SEEMED TO KNOW IT SO WELL. [LAUGHTER] THIS IS SOMETHING I CAN CONFIDENTLY SAY IS THE NIH NOT JUST THE NICHD LEADERSHIP'S VIEW OF THIS. AND TO STATE OBVIOUS THINGS THAT THE NIH REALLY HAS AN OBLIGATION, IT'S THE REASON WHY WE EXIST TO DO RESEARCH WITH SCIENTISTS AND FAMILIES AMONG MANY THINGS WE WANTED TO LOOK AT ARE OPTIMIZING CARE OF PREMATURE INFANTS PARTICULARLY BECAUSE THEY'RE SUCH A HIGHLY VULNERABLE GROUP. THE OUTCOME OF THE RECENT PUBLIC DEBATE ABOUT SUPPORT, WE REALIZE REALLY COULD AFFECT HOW WE CAN COMMUNICATE BOTH ABOUT RESEARCH AND INTERVENTIONS WITHIN THE STANDARD OF CARE FOR ALL DISEASES AND CONDITIONS I'VE ALREADY SAID NOT JUST IN TERMS OF PREMATURITY. WE FERMLY BELIEVE THAT WHEN THE STUDY BEGAN [INDISCERNIBLE] RANGES OF 85-95% IT WAS COMMON OF STANDARD PRACTICE. THE AP ISSUED GUYLINES IN 2007 THAT REFLECTED THAT P THIS THAT THE SUPPORT [INDISCERNIBLE] INCLUDING THINGS FOR SUPPORT, THE PRACTICE CLINICIANS AND [INDISCERNIBLE] AT THAT POINT HAD NO -- THIS IS FORGETTING FOR THE MOMENT BECAUSE IT HASN'T GOT SO MUCH OF THE KIND OF ATTENTION NOT THE QUESTION ABOUT SURFACTANT VERSUS C PAP BUT LOOKING AT THE O 2 SATURATION ASPECT OF THE STUDY THAT THERE WAS NO SCIENTIFIC EVIDENCE SUPPORTING MORTALITY BETWEEN THE HIGH AND LOWER TARGET GROUPS. AND ALSO TO UNDERSCORE THE FACT THAT LARGELY IT'S RESULT OF SUPPORT ALSO BECAUSE OF THE OTHER TRIALS THAT WALLY AND ROSE TALKED TO YOU ABOUT. LAST YEAR AMENDED GUIDELINES, PHYSICIANS HAVE BEGUN TO CHANGE THEIR PRACTICE AND USING HIGHER SATURATION RATES TO REDUCE RISK OF DEATH EVEN THOUGH THAT DOES BRING WITH IT SOMEWHAT HIGHER RISK OF OP, CLEARLY THIS HAS CHANGED THE PRACTICE. THIS HAS IMPROVED THE LIVES OF PREMATURE INFANTS AND IT'S IMPORTANT NOT TO LOSE SIGHT OF THAT AND THIS STUDY COMPARED TWO ALTERNATIVES WHICH ARE IN BOTH STANDARD CRITICAL PRACTICE OFTEN LEAD TO IMPROVEMENTS. WE REALIZE AND APPLAUD THE FACT THAT OHRP HAS CHANGED WITH PROVIDING LEADERSHIP AND PROTECTING RIGHTS SUPPORTED BY DHHS AS BEEN ELUDED TO IN MARCH 2013 LETTER, OHRP ASSERTED ON THE WAY THEY EXAMINED THAT THE SUPPORT RESEARCHERS FAILED TO PROVIDE SUFFICIENT INFORMATION ABOUT THE RISKS POSE THE STUDY. HOWEVER AFTER OUR DETAILED REVIEW OF THE PROTOCOL OF THE RELEVANT CONSENT DOCUMENTS, THE MULTIPLE DOCUMENTS AND THE RESEARCH LITERATURE, WE RESPECTFULLY DISAPPEAR WITH OHRP'S CONCLUSIONS WHICH WE BELIEVE RESULT IN FUNDAMENTAL DIFFERENCE INTERPRETATION OF HOW THE REGULATION SHOULD APPLY TO THE STATE OF THE SCIENCE WHEN THE SUPPORT STUDY COMMENCED. ORHP SAID QUOTE THE LEVEL OF OXYGEN BEING PROVIDED TO SOME INFANT COMPARED TO THE LEVEL HAD THEY NOT PARTICIPATE COULD INCREASE DEATH. WE THINK THEY'RE FINDING IS DUALLY INFLUENCED BY RESEARCH FROM 1950s. -- [INDISCERNIBLE] MULTIPLE CONVERSATIONS I HAVE ENJOYED POINTING OUT THAT NFK THE PROBLEM WITH THE 50s IS THE WAY WE ADMINISTERED OXYGEN IN THE 50s WAS DIFFERENT T WAY WE MEASURED OXYGEN IN 50s WAS DIFFERENT BUT WE HAVEN'T EVEN INVENTED THE TERM NEONATOLOGY IN THE 1950s. CLEAR THINK FOLKS ADMINISTERING THIS WAS DIFFERENT. WE WEREN'T DEALING WITH 24-WEEK PREMATURE INFANTS IN THE 19 50Z. WHAT WE WERE DOING WAS DIFFERENT, ETC, ETC, SO THOSE STUDIES WE WOULD THINK ARE ARE FUNDAMENTALLY FLAWED. WE THINK [INDISCERNIBLE] FAILED TO ASSIGN PROPER WAY TO CONDUCT [INDISCERNIBLE] STUDIES IN THE 2000s WHICH USED SIMILAR TO THOSE IN SUPPORT. YOU SAW THE REVIEW ARTICLE WHICH IS PROBABLY MOST IMPORTANT FOR THAT. GIVEN THESE DATA, WE THINK THE INVESTIGATORS HAD NO REASON TO FORESEE THE THAT INFANTS IN ONE STUDY GROUP WOULD HAVE A HIGHER RISK OF DEATH THAN THOSE IN THE OTHER GROUP. OF COURSE, THE BABIES IN SUPPORT WERE FACING STNL RISK BECAUSE THEY WERE EXTREMELY PREMATURE, BUT THEIR CARE WAS NOT COMPROMISED FOR THE SAKE OF THIS STUDY. IT'S IMPORTANT TO UNDERSCORE THAT EVEN THOUGH OHRP DID TAKE ISSUE WITH THE CONSENT FORM DID NOT THINK THAT THE STUDY DESIGN WAS INETHICAL, IT WAS ETHICAL IN THEIR EYES. THE INCREASED RISK OF DEATH WAS SIGNIFICANT AND UNEXPECTED FINDING OF THE STUDY. IF WE HAD KNOWN THIS BEFORE THE STUDY BEGAN, CLINICAL CARE WOULD HAVE ACCOMPLISHED LOWER OXYGEN RANGE AND WOULD HAVE BEEN UNETHICAL AND A WASTE OF YOUR FUNDS TO DO THE STUDY. THE NIH IS COMMITTED ENSURING PERSPECTIVE RESEARCH AND THE PEOPLE WHO SPEAK FOR AND LOVE THEM WHICH IS CLEARLY FOR MUCH OF THE RESEARCH WE'RE INVOLVED IN, THAT IS RESEARCH OF CHILDREN, PARTICULARLY IMPORTANT. IT IS REALLY VITALLY IMPORTANT THAT GIVEN CLEAR COMPLETE AND ACCURATE INFORMATION ABOUT THE RISKS AND BENEFITS OF PARTICIPATING RESEARCH. WE'RE STRONGLY COMMITTED TO SUPPORTING RESEARCH STUDIES LIKE THESE WHICH INFORM CLINICAL CARE. THE PUBLIC [INDISCERNIBLE] AS THE PUBLIC DEBATES SURROUNDING SUPPORT IT'S SET THE STAGE FOR A NATIONAL DIALOGUE INVOLVED IN ETHICS, EXPERTS, ETC ON HOW WE BEST RESPECTED AND PROTECT PARTICIPATES AND HOW TO DEFINE REASONABLY FORESEEABLE RISKS AND RESEARCH WITHIN STANDARD OF CARE. THIS IS UNDERSCORED THE FACT THAT THIS HAS BEEN MUDDLED AND WE NEED TO GET BETTER CLARITY HERE AND WE LOOK FORWARD TO WORKING WITH ALL OF THE STAKEHOLDERS OF WHICH THERE ARE MANY OF SEEING THIS TO ADVANCE THIS DIALOGUE TO HELP TRANSLATE THEM TO CLEAR GUIDANCE IN ACCORDANCE WITH THE PLAN ANNOUNCED YESTERDAY BASICALLY YESTERDAY THERE WAS THIS REACHING 5:00 YESTERDAY WITH NEW ENGLAND JOURNAL, TWO PIECES APPEARED. THE OHRP SENT THEM THE LET TER DAY BEFORE BUT THERE'S ALSO APPEARED ON THEIR WEB SITE WHICH BASICALLY SAYS THE FOLLOWING, THE WEB SITE WWW.HHS.GOV/OHRP WOULD SEE THIS AND NOT QUITE WORD FOR WORD BUT ALMOST SHEER THE PLAN WHICH IS ANNOUNCED THAT THE DEPARTMENT OF HEALTH AND HUMAN SERVICES WILL BE HOLDING A PUBLIC MEETING SO DISCUSS HOW CERTAIN PROVISION OF THE HHS PROTECTION HUMAN SUBJECTS REGULATIONS 45 CFR PART 46 SHOULD BE APPLIED TO RESEARCH STUDY INTERVENTIONS USED AS [INDISCERNIBLE] TREATMENT CLINICAL CONTEXT. THE DEPARTMENT SPECIFICALLY REQUESTING [INDISCERNIBLE] HOW AN IRB SHOULD ASSESS THE RISK OF RESEARCH RANDOMIZATION TO ONE OR MORE TREATMENTS WITHIN THE STANDARD OF CARE FOR PARTICULAR INTERVENTIONS AND WHAT REASONABLY FORESEEABLE RISK OF THEIR SEARCH SHOULD BE DISCLOSED TO SUBJECTS IN THE INFORMED CONSENT PROCESS. THIS WOULD BE A VERY IMPORTANT MEETING. WE HOPE COMING OUT OF THIS MEETING TO AGAIN TO TRY TO GET THE KIND OF CLARITY THAT IS NEEDED IN THE RESEARCH COMMUNITY TO MOVE FORWARD WITH THIS. WE CLEARLY THINK THAT WE WILL ALL BENEFIT FROM EXPLICIT DESCRIPTION OF AS WELL AS THAT OF EXACTLY HOW OHRP INVESTIGATES COMPLAINTS. WE THINK THAT HAS NOT BEEN SUFFICIENTLY CLEAR. WE'RE VERY PLEASED TO SEE THAT THE HHS PLANNED TO ENSURE THAT WE HAVE A FAIR AND TRANSPARENT PROCESS FOR APPEALING OHRP FINDINGS. WE ALSO THINK THAT'S [INDISCERNIBLE] AND LOOK FORWARD TO WORKING WITH OHRP AND PATIENT ADVOCACY GROUPS AND OTHERS TO IMPROVE EFFECTIVENESS AND ETHICAL STANDARDS OF RESEARCH. REMINDER WHAT THIS IS ALL ABOUT IN TERMS OF SUPPORT TRIAL, ITSELF, AND WHY THIS KIND OF RESEARCH IS SO FUNDAMENTALLY IMPORTANT AND THE REASON WHY WE'RE ALL IN BUSINESS. SO WITH THAT, I THINK QUESTION STOP. I DON'T KNOW IF THERE ARE ANY QUESTIONS OR THOUGHTS ABOUT THAT BEFORE WE MOVE TO FAIRLY SHORTLY TO SOME CONCEPT CLEARANCE WE WANT TO HAVE DONE BEFORE LUNCH. WE WANTED TO GET ALL OF THAT IN FRONT OF YOU. IF THERE ARE QUESTIONS -- I SHOULD SAY THE OHRP LETTER IF YOU'RE INTERESTED, IT IS ALSO ON THEIR WEB SITE AT THIS POINT SO IF YOU WANT TO READ MORE DETAILS ABOUT EXACTLY -- WE THOUGHT ABOUT SENDING IT AROUND BUT IT'S SEVEN PAGES, I BELIEVE, ETC, BUT IT'S ON THEIR WEB SITE AS WELL. GEORGE. >> WHAT PROMPTED THIS INVESTIGATION? >> A GROUP, PARTICULARLY INTERESTED IN RET NOP THINK CALLED OHRP'S ATTENTION TO WHAT THEY THOUGHT WERE WEAKNESS OR LAPSES IN THE CONSENT AND SO THEY ASKED OHRP TO TAKE A LOOK AT IT. THAT'S REALLY WHAT SPARKED IT. GOOD QUESTION. WELL, AGAIN, I THANK YOU FOR YOUR ATTENTION FOR THIS. I HOPE YOU WILL HELP US THINK ABOUT THIS BROADER QUESTION OF RESEARCH WITHIN THE STANDARD OF CARE AND HOW DO WE MOST EFFECTIVELY AND MOST ETHICALLY CONDUCT THAT? YOU KNOW, WAS THE CONSENT PROCESS IN SUPPORT PERFECT? NO, I'VE YET TO MEET A STUDY IN WHICH THE CONSENT PROCESS WAS PERFECT AND WE IMPROVE THE WAY WE E DO ALL OF THESE THINGS, YES. I THINK OUR VIEW OBVIOUSLY E WAS THERE ANY FUNDAMENTAL FLAW HERE, NO. IT WAS IMPORTANT RESEARCH, IT WAS DONE BY HONORABLE PEOPLE DOING INCREDIBLY IMPORTANT WORK, AND WE FEEL, I THINK SORRY, FOR WALLY AND OTHERS THAT HAVE HAD TO PUT UP WITH SOME [INDISCERNIBLE] UNREASONABLE IN THE GENERAL PRESS ETC, SPECIFICALLY, WHEN THEY WERE DOING REALLY IMPORTANT WORK. SO WE THANK WALLY AND OTHERS FOR THEIR ROLE IN DOING THIS. WE'RE PROUD OF HAVING HELP SUPPORT THE SUPPORT TRIAL OF THE WORK WITHIN NEONATAL RESEARCH NETWORK AND AT THE SAME TIME THE SILVER LINING IN THIS IS THAT WE THINK THE FOCUS IS GIVEN TO A NUMBER OF UNCLEAR POLICIES, ETC, IT'S VERY USEFUL. SO WE THINK THAT WE ACTUALLY WOULD BENEFIT THE WHOLE RESEARCH ENTERPRISE BY THE WAY THIS WORKS ITS WAY OUT. SO WE HOPE YOU WILL BE ACTIVE PARTICIPANTS TO US, ADVISORS TO US AND YOUR HOME INSTITUTIONS IN THIS DIALOGUE. THERE WILL BE MUCH MORE DETAIL WITHIN THE NEXT DETAIL ON THE OHRP'S WEB SITE ABOUT THIS MEET THAT WILL WILL B HELD THIS SUMMER AND THEY'RE GOING TO INVITE PUBLIC COMMENT AT THAT SO IF YOU HAVE COMMENTS YOU'D LIKE TO MAKE TO MAKE SURE THEY'RE TAKEN INTO CONSIDERATION, PLEASE MAKE THOSE. SO THEN WE ARE GOING TO MOVE ON TO SOME CONCEPT CLEARANCES. >> BEFORE I HAVE TRENT TO BEGIN WITH THE ONE THAT HE'S PRESENTING, JUST WANT TO GIVE YOU A QUICK UPDATE ON CONCEPT CLEARANCES AND WHY THEY COME TO COUNCIL. NUMBER ONE, YOU SHOULD KNOW THAT THE CONCEPT CLEARANCES BEFORE THEY COME TO COUNCIL, STAFF HAS SPENT A LOT OF TIME TALKING ABOUT THE VALUE OF CONDUCTING RESEARCH IN A PARTICULAR AREA AND OFTENTIMES IT'S AN AREA IN WHICH WE'VE ALREADY BEEN SUPPORTING IN THE CONCEPTS REFLECT A RENEWAL OF A PARTICULAR MECHANISM OR PARTICULAR AREA OF SCIENCE. ALAN AND I GET A CHANCE TO REVIEW THESE CONCEPTS FROM THE CONTEXT OF FEASIBILITY, HOW HIGH PRIORITY THEY MIGHT BE FOR THE INSTITUTE GIVEN DIVISIONING PROCESS AND WHERE WE SEE SCIENCE GOING IN LIMITED FUNDING CONSTRAINTS. THE CONCEPT THAT YOU WILL BE LOOKING AT TODAY ARE CONCEPTS THAT ACTUALLY SET ASIDE DOLLARS HAVE BEEN PROPOSED FOR THEM BECAUSE WE DO CONCEPTS ACTUALLY ALMOST TWO YEARS PRIOR TO WHEN THEY'RE PUT OUT ON THE STREET BECAUSE WE NEED TIME TO DEVELOP THE CONCEPTS, WRITE THE RSA, WRITE THE INITIATIVES. WE BRING THEM TO COUNCIL IN THE OPEN SESSION BECAUSE IT'S REQUIRED THAT ANY INITIATIVE OF THE THOUGHT FOR WHICH PUBLIC DOLLAR ARE USED, THE PUBLIC HAS A A RIGHT TO HEAR WHAT WE'RE PROPOSING TO DO THAT'S NEW OR DIFFERENT. THESE ARE MEETINGS AS YOU KNOW ARE PUBLISHED IN THE FEDERAL REGISTER WHICH MEANS THAT OUTSIDERS CAN COME TO COUNCIL AND BE PART OF THE OPENING SESSION TO HEAR THESE THOUGHTS OF CONCEPTS. THAT'S WHY WE DON'T PUT A LOT OF TIME INTO THE PRESENTATIONS AND ACTUALLY ASK STAFF TO BE VERY SUCK -- SUCCINCT IN FRIENDING, BUT WE WANT YOUR INPUT OF BEING VOICE OF THE COUNCIL AND PUBLIC BECAUSE THIS IS DONE IN A PUBLIC HEADING. WE MAY HAVE NOT ALLOWED ENOUGH TIME FOR TO YOU MAYBE DELVE INTO ANY PARTICULAR QUESTIONS OR CONCERNS YOU MIGHT HAVE BUT STAFF KNOWS THAT THEY ARE LIMITING TO THEIR THREE MINUTES OR NO MORE THAN TWO TO THREE MINUTES TO GIVE YOU AN OVERVIEW OF WHAT THESE CONCEPTS ARE AND THEN WE CERTAINLY WOULD WANT YOU INPUT AS TO WHETHER YOU AGREE WITH US THAT THEY'RE FEASIBLE OR THAT WE SHOULD MOVE FORWARD TO GET THEM OUT ON THE STREET IN 2014 BECAUSE THESE WOULD BE FUNDED IN 2014. TO GIVE YOU A SENSE OF HOW WE DO THINGS, WE ARE NOW GETTING READY TO HAVE OUR OPERATIONAL PLANNING SESSION FOR 2015. SO WHEN WE MEET ON [INDISCERNIBLE] OFFICE OF SCIENCE POLICY -- COMMUNICATION ORGANIZE AROUND US AROUND OUR ORGANIZATIONAL PLAN PLANNING PROCESS AND THAT'LL TAKE PLACE IN AUGUST. WITH THAT LITTLE BIT OF INTRODUCTION, TRENT, YOU WANT TO BEGIN WITH YOUR CONCEPT ON NON-HORMONAL FEMALE CONTRACEPTION [LOW AUDIO]. >> THANK YOU. THE CONTRACEPTIVE DISCOVERY AND DEVELOPMENT BRANCH IS PROPOSING TOISH UH AN RFA NON-HORMONAL CONTRACEPTIVE DEVELOPMENT PROGRAM USING THE UO 1 COOPERATIVE AGREEMENT. THIS PROGRAM WOULD MIRROR OUR MALE CONTRACEPTION DEVELOPMENT PROGRAM WHICH ALSO USES THE UO ONE MECHANISM. THE PURPOSE OF THE PROGRAM WOULD BE TO STIMULATE DEVELOPMENT OF MODEL TARGETED NON-HORMONAL SEPGSS FOR WOMEN. IT WOULD ENCOURAGE BASIC RESEARCHERS IN FIELDS OF REPRODUCTIVE BIOLOGY AND OTHER RELATED FIELDS TO THINK ABOUT WAYS TO EXPLOIT THEIR OWN ARE RESEARCH WITH THE ULTIMATE GOAL OF CONTRACEPTIVE PRODUCT DEVELOPMENT. THE GOAL IS TO IDENTIFY UNIQUE DRUGABLE TARGETS IN THE FEMALE REPRODUCTIVE SYSTEM MOST LIKELY INVOLVING FLICK LAR DEVELOPMENT. WE'LL ENCOURAGE A PRACTICAL APPROACH ASKING APPLICANTS TO THE PROPOSE A PLAUSIBLE EXPLANATION FOR HOW TO POTENTIAL TARGETS COULD BE MANIPULATED OR REGULATED BY EXTERNAL AGENTS THAT HAVE THE POTENTIAL OF BEING CONTRACEPTIVE. THE ULTIMATE OBJECTIVE IS TO IDENTIFY COMPOUNDS THAT WOULD BE CONTRACEPTIVE AND WOULD ACT ON TARGETS OF FEMALE REPRODUCTIVE PRACTICES AND HELP SYSTEMIC SIDE EFFECTS EXPERIENCED WITH HORMONAL CONTRACEPTIVES. >> LIKE TO HEAR FROM COUNCIL, YOUR VIEW ON THIS TOPIC AND WHETHER YOU THINK IT'S FEASIBLE FOR US TO CONTINUE MOVING FORWARD AS WE'VE PLANNED AND IF YOU HAVE ANY COMMENTS. >> VERY SUPPORTIVE OF MORE CONTINUE SEM ACCEPTTIVE RESEARCH, BOTH THE MALE AND FEMALE. I WONDERED WHY YOU LIMITED IT TO NON-HORMONAL. >> WELL, WE ARE DOING QUITE A BIT OF HORMONAL CONTRACEPTION RESEARCH AT THE MOMENT. THE VAST MAJORITY OF THE RESEARCH CERTAINLY IN FEMALE CONTRACEPTION CURRENTLY IN OUR PORT FOAL O OWE IS HORMONAL AND WE ONLY HAVE A FEW, MAYBE THREE SMALL PROJECTS LOOKING AT NON-HORMONAL TARGETED APPROACHES, SO WE'RE HOPING TO SORT OF STIMULATE MORE INTEREST IN THIS AREA AND I MUST SAY HAVING BEEN PRESCRIBING ORAL CONTRACEPTIVES FOR THE PAST 42 YEARS AND DEALING WITH THE PROBLEMS THAT HAVE ARISEN WITH THEM, I'D LIKE TO SEE OTHER ALTERNATIVES SYSTEMIC -- >> WELL, I WOULDN'T REFERRING TO THE CURRENT ESTROGEN OR PRO JES TIN BUT ARE YOU SUPPORTING NOVEL HORMONAL APPROACHES. >> WE ARE. >> IT'S H HARD TO GET THE PICTURE OF THE WHOLE PORTFOLIO BECAUSE CLEARLY THERE IS CERTAINLY ONES THAT SHOULD BE VERY SELECTIVE AND THE OTHER POINT IS THAT IF YOU TARGET -- I FOUND IT A LITTLE IRONIC TO BE TARGETING MOLECULAR DEVELOPMENT WITH A NON-HORMONAL -- WHETHER YOU DO IT NON-OR HORMONALLY YOU'RE GOING CHANGE THE HORMONE LEVEL IN WOMEN SUBSTANTIALLY AND THAT'S GOING TO HAVE EFFECTS ON BONE. >> TRUE. >> -- STAFF SHOULD MOVE FORWARD AND CONTINUE TO DEVELOP THIS AND OF COURSE TRENT AND STAFF F ARE PLANNING TO USE CORPORATE AGREEMENT ROU ONE MECHANISM TO SOLICIT FROM THE COMMUNITY AT LARGE SO IT GIVES SOMEONE ON OUR STAFF AN OPPORTUNITY TO PARTICIPATE WITH THE SCIENTISTS ON THE INITIATIVE. SO IF I DON'T SEE ANY RED FLAGS OR HEAR ANYTHING FROM YOU THAT SUGGESTS THAT WE SHOULDN'T MOVE FORWARD THEN WE'LL ASSUME THAT YOU CONCUR WITH US AND TRENT YOU HAVE THE RIGHT TO MOVE FORWARD TO CONTINUE TO DEVELOP THIS. THANK YOU. THANK YOU SO MUCH. DR. MOSSENSON, WILL YOU WILL PRESENTING THE [LOW AUDIO] RFA? >> YES. THANK YOU. SO THE PURPOSE OF THIS INITIATIVE FROM THE MATERNAL IN PEDIATRIC INFECTION DISEASE BRANCH IS TO SOLICIT RO1 GRANTS TO ENHANCE BIOMANY MED CAN AND CLINICAL RESEARCH XABSTY FOR THE STUDY OF INTERACTION HIV AND PB IN INDIA. WHAT WE'RE DOING IS BUILDING ON INFRASTRUCTURE THAT HAS BEEN DEVELOPED BY NIAID. THEY ARE FUNDING PB CENTERS OF EXCELLENCE IN IBD YEAH THAT ARE ESTABLISHING LONGITUDINAL COHORTS OF TB PATIENTS AND THEIR CONTACTS ALONG FUNDAMENTAL RESEARCH LAB TOIRS AND THIS IS A COLLABORATION BETWEEN THE U.S. AND INDIA. THEY'RE DOING THIS REALLY BEAUTIFUL INFRASTRUCTURE TARGETED TO ADULTS WITHOUT REALLY TARGETING ANYTHING RELATED TO CHILDREN OR PREGNANT WOMEN. AND SO OUR FUNDING WILL ENSURE THAT THERE'S CAPACITY AT THESE IN THESE COHORTS TO ACHIEVE SCIENTIFIC AIMS SPECIFIC BOTH TO HIV INFECTED AND UNINFECTED CHILDREN AND PREGNANT WOMEN WITH TB THAT WOULD HAVE THE POE TEN STHOOL BE APPLIED ON A GLOBAL SCALE. WE'VE DECIDED TO DO THIS THROUGH RO1 GRANTS AS OPPOSED TO PROVIDING COFUNDING TO NIAID SO INVESTIGATE TORGS AT CENTERS OF EXCELLENCE CAN APPLY FOR THE RO1 GRANTS THAT WOULD BE TARGETED FOR ISSUES RELATED TO TB IN WOMEN AND CHILDREN. >> THANK YOU. ANY COMMENTS FROM COUNCIL? >> SURE, I THINK THIS IS A TERRIFIC INVESTMENT AND YOU'RE BASICALLY GETTING 90% FREE RIDE AS COURTESY OF NIAID AND IT'S A GOLDEN OPPORTUNITY. >> THANK YOU. KATHY REMINDED ME THAT I DIDN'T EXTEND AN INVITATION TO THE PUBLIC BUT ANYONE WHO IS NOT PART OF THE GOVERNMENT SECTOR WHO MIGHT STILL BE HERE IF YOU HAVE ANY COMMENTS. IF NOT, THEN LYNN, YOU AND STAFF MOVE FORWARD TO CONTINUE TO DEVELOP YOUR INITIATIVE. DR. BARIS, DATA SHARING. THAT'S INTERESTING FOR THE DEMOGRAPHIC RESEARCH BRANCH. >> [LOW AUDIO]. WHICH USES THE U 24 MECHANISM WHICH IS THE REE SOURCE RELATED RESEARCH PROJECT COOPERATIVE AGREEMENT. WHILE THIS IS SA RENEWAL TO ENCOURAGE INNOVATION AND COST EFFECTIVENESS THIS WILL BE AN OPEN COMPETITION. I'D LIKE TO NOTE THAT THIS CONCEPT ADDRESSES MANY OF THE THEMES ARTICULATED BY DR. GREEN IN HIS BIG DATA PRESENTATION BUT ON A MUCH SMALLER SCALE. THIS U 24 WILL SUPPORT ARCHIVING, DOCUMENTATION, DISSEMINATION OF DEMOGRAPHIC AND OTHER POPULATION SCIENCE DATA AND ON A LIMITED BASIS, OTHER DATA COLLECTED WITHIN NICHD SUPPORT INCREASING IMPACT OF NICHD FUNDED RESEARCH PROJECTS BUT EXPANDING USE OF DATA COLLECTED THROUGH OUR GRANTS AND RESEARCH TEAMS OUTSIDE THE ORIGINAL GRANTEES. IN ADDITION THIS WILL SUPPORT THE DEVELOPMENT OF METHODS AND BEST PRACTICES FOR INTEGRATING DATA FROM UH STUDIES THAT INCLUDE BOTH DATA THAT CAN BE STORED IN ELECTRONIC FORMAT AND BIOMARKERS. TO CONCLUDE, THIS U 24 WILL SEEK TO IMPROVE HUMAN SUBJECT PROTECTIONS ESPECIALLY PRIVACY PROTECTION BY SHIFTING DATA ARCHIVING AND DISSEMINATION TO SCIENTISTS WHO ARE EXPERTS AT THESE TASKS. CURRENTLY, A LOT OF THE AD HOC ARCHIVING PEOPLE ARE NOT AWARE OF SOME OF THE DISCLOSURE RISKS THAT CAN BE, UM, THE DISCLOSURE OF CONFIDENTIALITY TO SO HAVING THIS DONE IN A SYSTEMATIC FASHION CAN BE HELPFUL. ALSO SEEK TO PROMOTE THE DEVELOPMENT OF CUTTING EDGE COST E EFFECTIVE PROCEDURES AND TECHNOLOGY FOR DATA SHARING AND DISSEMINATING BEST PRACTICES AND DATA SHARING TO OTHER SCIENTISTS IN OTHER DISCIPLINES. >> ANY QUESTIONS, COMMENTS? I SHOULD AD THAT SHE AND SEVERAL OF OUR STAFF HAVE COME TOGETHER TO SORT OF MAKE A TRANCE NICHD WORKING GROUP AROUND DATA SHARING AND THIS IS AN EXAMPLE OF TYPES OF THINGS THAT CAN COME OUT OF THIS TYPE OF DISCUSSION. ANYTHING ANYBODY WANT TO PUT ON THE TABLE REGARDING THIS? ANYBODY ELSE FROM THE PUBLIC? IF NOT REGINA, YOU CAN CONTINUE AND SPEND A LITTLE BIT OF MONEY WE HAVE FOR YOU. [LAUGHTER] DR. REN WILL PRESENT THE OB STRE TRICKS FETAL PHARMACOLOGY NETWORK WHICH I THINK IS A RENEWAL. >> SORRY. YEAH, THIS IS A RENEWAL BEEN AN RFA [INDISCERNIBLE] NETWORK. WE'LL USE A COOPERATIVE AGREEMENT FOR A MECHANISM. THE PURPOSE OF THIS RFA IS TO PROMOTE AND ATTEND A MULTICENTER RESEARCH NETWORK FOR OBSTETRIC PHARMACOLOGY TO [INDISCERNIBLE] CLINICAL STUDY OF [INDISCERNIBLE] DRUGS SO -- PREGNANT WOMAN. RFA WILL SOLICIT A NEW AND RENEWAL [INDISCERNIBLE]. THE NETWORK WILL PERFORM STUDIES OF FETAL, PLACENTAL AND MATERNAL PHARMACOLOGY INCLUDING EVALUATION OF THE PREGNANCY AND [INDISCERNIBLE] TRANSPORTERS AND THEIR ASSOCIATED SIGNALING PATHWAYS AND WILL ASSESS MA TERRIBLE IN FIT OF OUTCOME MEASURES OF DRUG EXPOSURE DURING PREGNANCY. WE'LL ALSO CONTINUE FOCUSING ON PHASE ONE AND PHASE TWO TRIALS AND DETERMINING FAR KOE KINETICS AND DYNAMICS OF THE JOBS THAT ARE OF [INDISCERNIBLE] VALUE DURING PREGNANCY AND DISPOSITION AND RESPONSE ARE ALTERED BY PREGNANT STATE IN NORMAL AND ABNORMAL PREGNANCIES INVOLVING CONDITIONS SUCH AS GESTATIONAL DIABETES, HYPER TENSION AND PRECAMPUS YEAH AND PRETERM BIRTH. THE OBJECTIVE OF THIS RFA IS TO FOSTER A MULTICENTER RESEARCH NETWORK TO IDENTIFY INNOVATIVE RESEARCH STRATEGIES IN OBSTETRIC PHARMACOLOGY RESEARCH WITH ULTIMATE GOAL OF IMPROVING THE SAFETY AND EFFECTIVENESS OF THE DRUG TREATMENT IN PREGNANT WOMEN. >> THANK YOU. ANY QUESTIONS? COMMENTS? I WAS GOING TO ASK YOU IF YOU HAD A QUESTION. >> [LOW AUDIO]. HERE WE GO. HOW ARE THE ACTUAL DRUGS THAT WILL GET STUDIED -- OBVIOUSLY YOU CAN ONLY BEGIN TO SCRATCH THE SURFACE OF THIS HUGE ISSUE, BUT AND THERE'S SO MANY NEO-PLASTIC CONDITIONS, INFECTION, EPILEPSY, SO MANY DRUGS THAT WE GIVE TO PREGNANT WOMEN AND I'M JUST CURIOUS ABOUT THE PRIORITIZATION. DO YOU HAVE A LIST OF WHERE THE BIGGEST PROBLEMS ARE AND WHERE YOU WANT THE FUNDING TO GO OR IS IT TOTALLY UP TO THE UNIT MEMBERS TO DECIDE THEIR PARTICULAR INTEREST? >> WELL, SO FOR THE CURRENT FUNDING CYCLES, WE HAVE THREE ON GANG NETWORK CLINICAL TRIALS AND BASICALLY THEY, THE PROPOSAL COMES PROPOSED BY SITE, INVESTIGATORS THAN THE NETWORK STEERING COMMITTEE WILL DECIDE PRIORITY BASED ON THE SCIENCE AND ALSO THE FEASIBILITY AND THE CLINICAL SIGNIFICANCE. SO RIGHT NOW WE HAVE LIKE I SAID THREE TRIALS ARE INCLUDING A A GESTATIONAL DIABETES THAT TWO JOBS ARE FOREMAN AND [INDISCERNIBLE] COMBINATION TRIALS AND ALSO THE SECOND TRIAL IS THE STA TON BEFORE PRECAMP YEAH AND -- PRECLAFRPS YEAH AND THE THIRD ONE IS FOR PRETERM BIT. WE ALSO HAVE OPTIMISTIC STUDIES THAT THE SIZE OF THE STUDY [INDISCERNIBLE] -- PREGNANT WHEN THEY COME TO CLINICAL AS A STAND OFF CARE. >> ANY OTHER QUESTIONS, COMMENTS? THEN DO WE HAVE YOUR CONSENT THAT WE SHOULD MOVE FORWARD? THANK YOU. MOVE FORWARD. >> WE HAVE ONE LAST ONE FOR YOUR CONSIDERATION IS DISCOVERY MOLECULAR TARGETS FOR PREGNANCY RELATED TO INDUCED DISEASES. DR. SOL WILL BE PRESENTING IT. >> HELLO. SO OUR BRANCH WHICH IS THE OBSTETRIC AND PEDIATRIC [INDISCERNIBLE] PROPOSE REQUEST FOR APPLICATIONS WHICH SET ASIDE THAT WILL [INDISCERNIBLE] DISCOVERY OF MOLECULAR TARGET FOR PREGNANCY RELATED INDUCED DISEASES AND [INDISCERNIBLE] PREVENT THESE DISEASES. WE PLAN TO USE THE SMALL BUSINESS [INDISCERNIBLE] PHASE ONE AND PHASE TWO, SO R 41 AND R 42 AND THE SMALL BUSINESS INNOVATION OF [INDISCERNIBLE] GRANT PHASE TWO R 44 AND R 43 MECHANISMS. DESPITE [INDISCERNIBLE] PREGNANCY ASSOCIATE DISEASES DRUG DEVELOPMENT FOR [INDISCERNIBLE] MINIMAL NON-EXISTENT SO THE PURPOSE OF THIS INITIATIVE IS TO IDENTIFY MOLECULAR TARGET THAT CAN LEAD TO DEVELOPMENT OF [INDISCERNIBLE] SAFE AND EFFECTIVE MEDICATIONS WITH PLANS TO [INDISCERNIBLE] APPLICATIONS WITH LIES [INDISCERNIBLE] PAPERS. SERIOUS APPROPRIATE FOR THIS ANNOUNCEMENT INCLUDE IDENTIFICATION OF NEW TARGETS FROM ALREADY IDENTIFIED PLIT CRITICAL MOLECULAR PATHWAYS USING [INDISCERNIBLE] SCREENING FOR DEVELOPMENT OF NOVEL THERAPEUTICS AS WELL AS TRIALS OF EXISTING EXPERIMENT DRUGS TO TARGET THOSE PATHWAYS. >> QUESTIONS? COMMENTS? YES. >> -- THE USE OF THE SPIR MECHANISM SO IF THE PROBLEM IS YOU CAN'T GET ANY OF THESE DEVELOPED FOLLOWING THE RESEARCH, WHAT'S THE POINT OF STARTING TO DEVELOP THEM IF YOU CAN'T GET THEM THROUGH THE PROCESS? >> WELL, WE ACTUALLY PLAN TO ENGAGE SMALL BUSINESS AS WELL. WE ARE GOING TO [INDISCERNIBLE] RO1 AT TRYING TO ENGAGE ACADEMIA SO WE HOPE TO BREED ACADEMIA WITH THE SMALL BUSINESSES HOPING THEY WILL TAKE DIFFERENT PROJECTS TO APPROACH THIS PROBLEM FROM DIFFERENT [INDISCERNIBLE] AND WE HOPE THAT SMALL BUSINESS THINKS AK DEM YEAH AND [INDISCERNIBLE] -- THINGS LIKE THAT. >> BUT THE MONEY'S AVAILABLE THROUGH THE SBIR PROGRAM WON'T GET THEM FAR ENOUGH LONG TO ACTUALLY ADVANCE THEM IN THE DEVELOPMENT OF THE DRUG, RIGHT? >> WELL, THERE ARE GOING TO BE PHASE ONE AND PHASE TWO. >> EVEN THEN. [LAUGHTER] >> THE GOAL OF THIS RFA IS TO IDENTIFY THE MOLECULAR TARGET WITH THE HOPE THAT YOU'D BE ABLE TO DEVELOP THE -- AT A LATER DATE. WE'RE HOPEFUL THE SMALL BUSINESSES WOULD BE ABLE TO DO SOME OF THAT AND OTHERS COULD TAKE [LOW AUDIO]. >> THERE WE GO. IT'S A GREAT IDEA AND IT'S IMPORTANT AND IT SHOULD BE DONE. I THINK IT IS IMPORTANT FOR THIS GROUP AND EVERYBODY IS PROBABLY AWARE OF IT THOUGH THAT IT'S NOT REALISTIC TO EXPECT AT LEAST IN THE UNITED STATES THAT ANY COMPANY WITH A REASONABLE LEGAL DEPARTMENT WILL GO FORWARD. UNTIL PRODUCT LIABILITY IS TAKEN OUT OF JURIES AND GIVEN TO EXPERTS, IT JUST ISN'T REASONABLE AND BECAUSE OF VINDECTIN WHICH HUGE AWARDS WERE GIVEN TO THAT AND THE COMPANY GAVE UP THE LIABILITY SUITS AND TOOK IT OFF THE MARKET AND IT'S BECAUSE EVEN THOUGH THERE WERE NO DIFFERENCES IN MALFORMATIONS AND THE SAME AND THEN FOR THE CASES WHERE THERE ARE PROBLEMS LIKE DIATHELSTEBESTEROL IT'S 38 YEARS SINCE IT WAS TAKEN OFF THE MARGARET, 58 PATIENTS ARE BRINGING LIABILITY SUIT GOING TO TRIAL STILL NOW FOR BREAST CANCER FOR VINDECTIN SO I DON'T THINK IT'S GOING HAPPEN. IT WOULD BE GOOD IF THE NIH IS SERIOUSLY CONSIDERED THIS TO THINK ABOUT WAYS THAT THE BIGGER PROBLEM COULD BE ADDRESSED BECAUSE OTHERWISE YOU'LL HAVE THE TARGET BUT I DON'T THINK ANY U.S. COMPANY, MAYBE SOMEONE IN INDIA WOULD DO IT, BUT I DON'T THINK ANYONE IN THE U.S. WOULD MAKE A DRUG FOR A PREGNANCY TARGET. >> [LOW AUDIO]. >> MAYBE JUST AS A FURTHER TO THIS, THE ADVANTAGE OF HAVING THESE TARGETS IS P IF YOU'RE REALLY LUCKY, IT'LL TURN OUT THAT SOME HOW OR ANOTHER IT'S ALREADY A TARGET FOR SOMETHING ELSE AND YOU DIDN'T REALIZE SO IT'LL BE ONE OF THESE THREE THOUSAND MARKETS, THREE THOUSAND DRUGS THAT NCATS HAS ALREADY GOTTEN RECOGNIZES AS HAVING BEEN APPROVED ZR FOR SOMETHING AND IT TURNS OUT, WOW, MAYBE IT WILL HELP PRECLAMP YEAH OR MAYBE IT WILL HELP THESE AND KIT BE USED OFF LABEL 'CUZ IT'S ALREADY AVAILABLE, BUT TO -- THAT'S HOW, THAT'S WHERE THIS FOCUS NEEDS TO BE, THE MORE SKILLFUL USE OFF LABELED IN PREGNANCY BECAUSE THE COMPANIES JUST CAN'T MARKET SPECIFICALLY FOR PREGNANCY UNDER OUR CURRENT LEGAL FRAMEWORK. >> [LOW AUDIO]. >> COMPLETELY. BECAUSE THE SCIENCE EVENTUALLY WILL LEAD, YOU'LL GET THERE, YOU KNOW, THERE'LL BE SOME WAY THAT ONCE YOU IF YOU HAVE BETTER SCIENCE ABOUT ABSOLUTELY I'M SUPPORTIVE. E I DIDN'T MEAN TO BE DISCOURAGING THAT WAY. I ACTUALLY WOULD RATHER ENCOURAGE -- I THINK WHEN SOCIETY GETS A ROADBLOCK ABOUT AN IMPORTANT PROBLEM, WE OUGHT TO COME TOGETHER TO SAY PRODUCT LIABILITY IS NOT SOMETHING THAT A JURY CAN PROPERLY UNDERSTAND. I MEAN, I THINK IT'S BEEN PROVEN AND SOMEBODY OUGHT TO BE WORKING ON THAT PROBLEM, OR THE GOVERNMENT SHOULD DECIDE TO MANUFACTURE OR INDEM ANY FIE PEOPLE WHO WORK IN TARGETED AREAS. THAT WOULD IMMEDIATELY OPEN IT UP, THEN YOU'D HAVE TONS OF PEOPLE WORKING ON THESE PROBLEMS, PARTICULARLY SMALL BUSINESSES. >> [LOW AUDIO]. -- ANY OTHER COMMENTS OR REMARKS? QUESTIONS? THEN WE'LL MOVE FORWARD TO CONTINUE TO DEVELOP THIS. THANK YOU. >> THANK YOU. >> THANK YOU, STAFF, FOR ADHERING TO YOUR TIME. >> [LOW AUDIO]. -- IS THERE ANYTHING THAT HAS NOT COME UP IN OPEN SESSION THAT ANY MEMBER OF COUNCIL WOULD LIKE THE BRING UP OR ANYONE ELSE? IF NOT, WE WILL CLOSE THE OPEN SESSION, WE WILL GO OPEN OUR MOUTHS FOR LUNCH, AND WE E WILL START AGAIN VERY PROMPTLY AT 1:15. SO WE ARE CLOSED, SO E WE WILL BE STARTING VERY PROMPTLY I SHOULD TELL YOU AT 1:15. WE'RE DELAYING THE START BY 15 MINUTES. WE WANT TO GET THROUGH SO PLEASE MAKE YOUR YOU'RE BACK