>> GOOD MORNING, EVERYONE I THINK IT'S THE WITCHING HOUR SO WHY DON'T WE START OUT. AS ALWAYS WE HAVE A VERY FULL AND VERY INTERESTING AGENDA FOR US. I'M NORMAN AUGUSTINE AND I'M CHAIRMAN OF THE SMRB AND I'M TOLD THIS IS THE 24th MEETING OF THE FULL BOARD WHICH SEEMS IMPOSSIBLE BUT THAT'S THE CASE. IT'S MEMORABLE MEETINGS AND TELEPHONE CALLS AND THE LIKES AND I'D LIKE TO WELCOME OUR INVITED GUESTS WHO WILL BE SPEAKING WITH US DURING THE COURSE OF THE DAY. OF COURSE, ANY MEMBERS OF THE PUBLIC THAT HAVE JOINED US, THEY'RE ALWAYS MORE THAN WELCOME AND I THINK BEFORE WE START OUT, JUST SINCE WE ARE BEING VIDEOCAST, IT'S PROBABLY WELL TO GO AROUND THE ROOM AND SORT OF SAY WHO WE ARE AND ALSO I'LL GIVE YOU A REMINDER, HAVE YOU THE PUSH TO TALK SYSTEM, IT'S ALSO PUSH TO NOT TALK WHEN YOU'RE DONE. [LAUGHTER] SO IF YOU WANT TO START OUT. >> IF I CAN HANDLE THE FIRST PART THERE,. >> MICHAEL FROM THE SCRIPTURE RESEARCH INSTITUTE. >> JOSIE BRIGS FROM COMPLIMENTARY HEALTH. >> AND I'M CONGRATULATIONS JOSIE ON HER NEWLY NAMED CENTER. >> I'M MARTHA WITH THE NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH. >> I'M SCOTT. >> CATHY HUDSON DIRECTOR FOR OUTREACH AND POLICY FOR PIT MAN. >> NANCY ANDREW FROM DUKE UNIVERSITY. >> GRIFFIN ROGERS DIRECTOR OF NATIONAL INSTITUTE OF DIABETES, DIGESTIVE AND KIDNEY DISEASES. >> ALAN TKPWAOUT MATCHER FROM THE LONG AGO NAMED KENNEDY SHRIVER INSTITUTE OF CHILD AND HUMAN HEALTH DEVELOPMENT. >> LINDA WITH THE NIEHS, AND THE NATIONAL TOXICOLOGY PROGRAM. >> LARRY SCHAPIRO, UNIVERSITY OF WASHINGTON. >> AND MAUREEN AND. >> THANK YOU FOR MUCH. WE HAVE ONE, TWO, THREE, FOUR, PEOPLE ON THE PHONE AND WILL BE HERE AT VARIOUS POINTS. LET ME JUST CHECK, COLLIDE - -CLYDE? GILL? >> HE WILL WILL JOIN IN ABOUT TWO MINUTES. >> GARY? LEE? OKAY WELL THEY WILL BE JOINING US AT VARIOUS POINTS DURING THE MEETING AND WE HAVE A COUPLE FOLKS UNABLE TO BE WITH US, ONE OF WHOM IS FRANCIS WHO IS I'M TOLD IN LONDON ATTENDING A RATHER CRITICAL MEETING AND HE'S GOING TO CALL US TO KIND OF GIVE US A RUN DOWN OF WHAT'S ON HIS MIND. AND WE HAVE GREAT NEWS, ONE OF OUR MEMBERS HERE TODAY IS MANAGED TO BREAK THROUGH THE BUREAUCRATEC PAPERWORK SYSTEM, CAITLIN WHO IS A FULL MEMBER ON THE PAY ROLL. WE ALSO HAVE SEVERAL MEMBER WHO IS ARE IN AN AD HOC CAPACITY. APPARENTLY SOMETHING IN YOUR BACKGROUND THAT'S TROUBLING THE SYSTEM. YOU MAY RECALL I TOLD THE STORY OF MY ARREST FOR RUNNING AN ILLEGAL LEMONADE STAND WITH MY GRANDCHILDREN, THESE THINGS CAUSE PROBLEMS. SO THAT REALLY DID. BUT ANYWAY, FOR THOSE FOUR FOLKS WE THANK YOU FOR BEING HERE AND PARTICIPATING. WE HOPE WE WILL GET THE PAPER ALL THROUGH THE SYSTEM FAIRLY SHORTLY. AND I DON'T KNOW, GILL ARE YOU OUT THERE NOW? >> NOT QUITE YET. >> I WAS GOING TO SAY SOME NICE THINGS ABOUT YOU SO I THINK I WILL HOLD THAT. >> I'LL SAY THE BAD THINGS NOW. >> OKAY, ALL RIGHT. AND SO, LET ME KIND OF GO THROUGH THE AGENDA FOR TODAY BECAUSE IT ALL FITS TOGETHER AND I THINK IT IS GOING TO BE A VERY INFORMATIVE AGENDA AND ALS ONE IN WHICH WE HAVE A VOTE ON, ONE OF IT IS REPORTS THAT IS ESSENTIALLY FINISHED, PENDING TODAY'S DISCUSSION OF COURSE. THIS WILL BE BE GOING OVER THE EXTREME LINING MANAGEMENT REVIEW PROCESS, GRANT STUDY, MICHAEL'S BEEN A CHAIRMAN OF THAT WORKING GROUP, HE WILL LEAD US THROUGH THIS, SPEAKERS THAT WILL TALK ON THAT TOPIC. I SHOULD NOTE THAT IN CONVERSATIONS ON THE HILL WHERE IN TRYING TO GET MORE KNOWY INVESTED IN RESEARCH AND INCLUDING BIOMEDICAL RESEARCH, ONE OF THE AREAS OF PUSH BACK, WHAT ARE THESE FOLKS DOING TO MAKE OUR SYSTEM MORE EFFICIENT SO THAT THE MONEY YOU DO HAVE GETS SPENT MORE EFFECTIVELY AND HOW OFTEN DESPITE THIS EFFORT ON BEHALF OF NIH, SOMETIMES YOU HEAR WHY SHOULD IT TAKE A YEAR TO FIND OUT WHETHER 83% PROBABILITY IS NEEDED OR NOT YOU'RE GOING TO GET FUNDED AND THE AMOUNT OF TALENT THAT GETS CONSUMED IN THAT PROCESS OR THE AMOUNT OF TIME IS KIND OF A BURDEN AND SO, PEOPLE ON THE HILL THAT I'VE TALKED WITH SORT OF WALK ON THE IDEA THAT NIH IS NOT ONLY ASKING FOR MORE FUNDING, BUT IS ALSO TRYING TO SPEND THE FUND ITS HAS MORE EFFICIENTLY. WE ARE GOING TO GET THE DISCUSSION THAT MICHAEL WILL LEAD AND THEN WE'LL HEAR FROM AN ACTING IC DIRECTOR ON ONE OF THE INSTITUTES APPROACHES THAT'S IMPLEMENTED TO THE DEGREE IN STREAMLINING THEIR FUNDING DECISIONS AND THEN WE WILL HAVE A PANEL OF APPLICANTS WHICH WILL BE VERY INTERESTING SHARE THEIR VIEWS ON THE GRANT PROCESS. AND THROUGH THE NIH'S CREDIT WHEN WE ASKED FOR PEOPLE FOR SPEAKERS ON TOPICS, THEY DON'T ALWAYS EPI-BLAST PICK PEOPLE THAT REPRESENT THE PARTY LINE, SOME HAD GOOD EXPERIENCES AND SOME HAD BAD EXPERIENCES AND WE WILL HEAR A BIT OF BOTH. AND THEN WE WILL TAKE A PAUSE IN THE DISCUSSION OF THE GRANT REPORT AND GET AN UPDATE ON THE NIH'S WORK ON EBOLA. WE ARE GOING TO HEAR FROM FRANCIS WHO WILL GIVE US A CALL FROM LONDON AND THEN THE RESTS OF THE DAY, WE WILL SWITCH TOPICS AND GO TO BIOMEDICAL ENGAGEMENT AND SCIENCE, THAT WORKING GROUP UNDER CLYDE HAS NEARLY COMPLETED ITS WORK, A FEW EDITORIAL OR ADMINISTRATIVE CHAIRMANS TO THE REPORT AND NO PLAN CHANGES UNLESS THIS GROUP FEELS OTHERWISE. AT THE END OF HIS REPORT WE'LL ASK FOR A VOTE OF APPROVAL BECAUSE WE WILL HAVE COMPLIED WITH THE LEGISLATION THAT CREATED THIS BOARD, THAT SAYS THAT WE HAVE TO MEET FIVE TIMES ON ANY GIVEN TOPIC BEFORE WE CAN VOTE. AS I WAS COMMENTING TO MARIE EARLIER THIS MORNING, I HAVE A HARD TIME MANAGING THE COMPANY I USED TO BE INVOLVED WITH THAT THE BOARD WOULD EVER SAY WE HAVE TO MEET FIVE TIMES BEFORE WE MAKE A DECISION AND HAD THE BOARD TOLD US THAT, I SUSPECT WE WOULD HAVE WALKED IN AND OUT OF THE ROOM FIVE TIMES BEFORE VOTING AND YOU CAN ALWAYS BEAT THIS, AND LET'S SEE, BEFORE WE GO AHEAD THOUGH THERE ARE A COUPLE OF AOEURBG TEMS THAT COVER THAT SORT OF THE ADMINISTRATIVE ONE, IS THAT WE OF COURSE WELCOME PUBLIC COMMENT AND THOSE ARE THE PUBLIC WHO ARE LISTENING ELSEWHERE, WHO ARE HERE IN THE ROOM THERE IS A SIGN UP SHEET OUTSIDE FOR THOSE IN THE ROOM. IF YOU WOULD LIKE TO TALK, WE WOULD WELCOME THAT AND THERE WILL BE A SIGN DESIGNATED THIS AFTERNOON, WE DO AS ASKED AND ASK TO HOLD YOUR COMMENTS IN FAIRNS TO OTHERS AND TO THOSE WHO ARE NOT HERE IN THE ROOM AFTER THOSE WHO SIGNED UP HAVE AN OPPORTUNITY, WE'LL CALL ON OTHERS TO COMMENT AS THEY MAY SEE FIT. ALSO FOR MEMBERS OF THE PUBLIC WHO DON'T WANT TO COMMENT PUBLICLY, YOU HAVE THOSE WHO ARE ON THE COMMITTEE'S WEB SITE AND INCLUDED THE MEMBERS MATERIALS THAT WEAKENED OUT SO THE COMMENTS WILL BE CARED CAREFULLY AND WE NEED TO ANOTHER ADMINISTRATIVE ITEM, WE HAVE THE OCTOBER SMRB MINUTES, GARY GIBBONS HAS REVIEWED THOSE AND BELIEVES THAT THOSE ARE APPROPRIATE AND WOULD ANYBODY MAKE A MOTION TO APPROVE. >> SO MOVED. >> GREAT. GIL, HOW ARE YOU, THANK YOU? IS THERE A SECOND? I'LL TAKE THAT. IS THERE DISCUSSION, THOSE IN FAVOR SAY AYE. >> AYE. >> THOSE OPPOSED ARE APPROVED. >> GIL, WELCOME, HOW ARE YOU TODAY. >> HELLO, EVERYBODY. >> GILIT'S GREAT TO HAVE YOU HERE AND I WANT TO NOTE IT'S PREMATURELY FAREWELL BECAUSE YOU'LL BE WITH US ALL DAY BUT YOUR TERM IS ENDING AS YOU KNOW AND I JUST WANT TO SAY THAT GILL'S BEEN ONE OF THE STELLAR MEMBERS OF THIS GROUP AS EVERYBODY KNOWS AND HE SERVE OFFICE OF DIVERSITY THREE WORKING GROUPS, PARTICIPATED 12 MEETINGS THE FULL SMRB AND 30 WORKING GROUP TELECONFERENCES AND THAT'S--I SAY THAT FOR TWO REASONS, ONE IS TO POINT OUT WHAT A CONTRIBUTION GILL AS MADE BUT SECONDLY TO KNOW WE KEEP TRACK OF YOU AROUND HERE. [LAUGHTER] VERY IMPRESSED WITH IT BUT HE WORKED ON THE VALUE OF BIOMEDICAL RESEARCH GROUP, THE GRANT REVIEW AWARD MANAGEMENT PROCESS AND PRECOLLEGE ENGAGEMENT AND BIOMEDICAL SCIENCES THAT'S UNDERWAY. A COUPLE OF THOSE GROUPS ARE ON THEIR WAY AND I NEVER CEASE TO BE AMAZED BY THE AMOUNT OF EFFORT HE PUTS IN. THEY COME IN WITH LOG SHEETS OF COMMENTS AND CAREFULLY THOUGHT-THROUGH INPUT AND I DON'T KNOW HOW YOU DO IT ALL AND HE'S CONSTANTLY ROAMING AROUND THE WORLD AND GIVING TALKS AND LAST YEAR I WAS OUT IN THE RED WOODS OF CALIFORNIA FOR THE BOHEMIAN GROVE WHO SHOULD SHOW UP UNDER ONE OF THE RED WOODS BUT OUR SPEAKER GIL. SO WE'RE VERY INDEBTED TO YOU AND WE'RE GLAD TO HAVE YOU WITH US TODAY. >> THANK YOU NORM, IT'S BEEN A GREAT PLEASURE. >> I HAVE TO BE CAREFUL I DON'T I HAVEOLATE A RULE HERE. I THINK THE NEXT THING IS TO CALL ON YOU MARINA TO COVER THE CONFLICT OF INTEREST RULES. >> THIS IS MY STARRING MOMENT. AT LEAST I REMEMBERED TO BRING GLASSES. SO AS MEMBERS OF THIS COMMITTEE, YOUR SPECIAL GOVERNMENT EMPLOYEES AND ARE THEREFORE SUBJECT TO RULES OF CONDUCT THAT APPLY TO GOVERNMENT EMPLOYEES. THESE RULES AND REGULATIONS ARE EXPLAINED IN A REPORT TITLED STANDD OF ETHICAL CONDUCT FOR THE EMPLOYEES OF THE EXECUTIVE BRANCH AND YOU EACH RECEIVED A COPY OF THIS DOCUMENT WHEN YOU WERE APPOINTED TO THE COMMITTEE. IN EVERY MEETING IN ADDITION TO REMINDING YOU OF THE IMPORTANCE OF THE ETHICS RULE, WE TRIKE REVIEW THE STEP WE TAKE AND ASK TO YOU TAKE TO INSURE THAT ANY CONFLICTS OF INTEREST BETWEEN YOUR PUBLIC RESPONSIBILITY AND YOUR PRIVATE ENTER INTERESTS AND ACTIVITIES ARE IDENTIFIED AND ADDRESSED. BEFORE EVERY MEETING YOU PROVIDE US WITH INFORMATION ABOUT YOUR PERSONAL, PROFESSIONAL AND FINANCIAL INTEREST, WE USE THIS AS A BASIS FOR ASSESSING WHETHER HAVE YOU ANY REAL POTENTIAL OR APPARENT CONFLICTS OF INTEREST THAT COULD COMPROMISE YOUR ABILITY TO BE OBJECTIVE IN GIVING ADVICE DURING COMMITTEE MEETINGS, IF SUCH CONFLICTS ARE IDENTIFIED WE ISSUE A WAIVER OR RECUSE YOU FROM A PARTICULAR PORTION OF THE MEETING. WE USUALLY WAVE CONFLICTS OF INTEREST FOR GENERAL MATTERS BECAUSE WE BELIEVE YOUR ABILITY TO BE OBJECTIVE WILL NOT BE EFFECTED BY YOUR INTEREST IN SUCH MATTERS. SO WE ALSO RELY TO A GREAT DEGREE ON YOU TO BE ATTENDIVE DIFFING OUR MEETINGS TO THE POSSIBILITY THAT AN ISSUE ARISES THAT ACCOUNTED EFFECT OR APPEAR TO AEFFECT YOUR INTEREST IN A SPECIFIC WAY. IF THIS HAPPENS WE ASK TO YOU RECRUISE YOURSELF FOR THIS QUESTION. IF HAVE YOU ANY QUESTIONS ABOUT RULES OF CONDUCT OR CONFLICT OF INTEREST OR COMMITTEE MANAGEMENT OFFICER, LISA ROUSTON WILL BE HAPPY TO ADDRESS THEM. >> THANK YOU, MARINA, I MAKE LIGHT OF THAT A BIT BUT IT IS IMPORTANT. I HAD AS OCCASION TO SERVE AS INVESTIGATOR ON DIFFERENT CASES OR ORGANIZATIONS WHERE CONFLICTS CAME UP THAT WERE CONFLICTS AND BOY, NOTHING COULD DO MORE DAMAGE TO OUR ORGANIZATION THAN TO HAVE A CONFLICT OF INTEREST. SO WE WILL BE MINDFUL OF THAT. I THINK THE NEXT THING WE WANT TO DO, WE ALWAYS GIVE FRANCIS AN OPPORTUNITY TO TALK TO US ABOUT WHAT'S HAPPENING AT NIH AND IN HIS ABSENCE CATHY HUDSON, DEPUTY DIRECTOR FOR SCIENCE OUTREACH AND POLICY WHICH IS VERY MUCH CENTRAL TO ORIGINAL INTEREST IS HERE TODAY AND SHE'S GOING TO BE REPRESENTING FRANCIS DURING THE MEETING AND HAS BEEN KIND NOTIFY TO OFFER TO TELL US A LITTLE BIT ABOUT WHAT'S GOING ON AT THE NIH. >> GOOD MORNING, THANK YOU. >> I'M JUST GOING TO READ THIS SITTING HERE. >> SO WHAT I LIKE TO DO THIS MORNING IS DO A QUICK ROUND THROUGH ACTIVITIES AND EVENTS THAT HAVE TAKEN PLACE SINCE YOU ALL LEFT, MET, A COUPLE OF MONTHS AGO, AND TALK ABOUT NEW DEVELOPMENTS WHICH ARE ALL AWARE OF GIVEN THE NEWS THAT'S BEEN GENERATED. I WANT TO TALK ABOUT A VISIT FROM A VERY IMPORTANT PERSON TO CAMPUS, A COUPLE WORDS ABOUT SOME PROPOSED POLICIES THAT NIH GENERATE THAD UNIQUE FUND OF INTEREST AND LASTLY I WOULD LIKE TO GIVE YOU A BIT OF AN UPDATE FROM YOUR SISTER COMMITTEE, THE ADVISORY COMMIT TO THE DIRECTOR OF THE NIH WHICH ACTUALLY MET LAST THURSDAY AND FRIDAY, SO SOME OF US HAVE SPENT MORE TIME THAN WE WOULD HAVE WANTED SIT NOTHING THIS VERY ROOM. SO STARTING WITH THE BUDGET HAVE YOU HAVE HEARD, THE CONGRESS DID PASS OVER THE WEEKEND A BUDGET FOR FY15, IT WAS THE CRNICKUS, IT IS A CR FOR ONE PART. IT CONTAINS SPENDING PROPOSALS FOR THE ENTIRE FISCAL YEAR. IT INCLUDES 33.3 BILLION DOLLARS WHICH IS AN ITTY BITTY INCRISE OVER LAST YEAR BUT IT IS NONETHELESS AN INCREASE. IT ALSO PROVIDED 238 MILLION DOLLARS TO THE NATIONAL INSTITUTE OF 5*8ERGY AND INFECTIOUS DISEASE FOR EMERGENCY FUNDING FOR EBOLA AND THAT DOESN'T COUNT TOWARDS THAT TOTAL. SO YOU COULD CONSIDER IT ACTUALLY A LARGER INCREASE. WE ARE STILL BEBELOW THE 2012 PRESEQUESTRATION LEVELS AND OF COURSE THE INCREASE THIS YEAR IS NOT ABLE TO KEEP UP WITH THE BIOMEDICAL RESEARCH PRICE INDEX. AS ESCROWSY MENTIONED, THEY WILL ALSO PROVIDED A NEW NAME FOR THE NATIONAL CENTER FOR COMPLIMENTARY AND ALTERNATIVE MEDICINE AND NOW THE NATIONAL CENTER FOR COMPLIMENTARY AND ALTERNATIVE HEALTH. CAN YOU PRONOUNCE THAT? OKAY. IT ALSO--THE APPROPRIATIONS BILL ALSO REQUIRES THE CALL OF A FIVE YEAR NIH STRATEGIC PLAN. WE HAVEN'T HAD AN OPPORTUNITY TO TALK MUCH ABOUT THAT AROUND HERE BUT WE WILL CERTAINLY BE HEARING ABOUT THAT AND SORT OF A REQUIREMENT WHICH I WOULD BE INTERESTED TO TALK TO THE STAFF MORE ABOUT ON THE HILL THERE'S A REQUIREMENT TO PROVIDE AN REQUIREMENT TO SUPPORT ACADEMIES STUDY TO DEVELOP RECOMMENDATIONS TO APPROVE SCIENTIFIC LITERATESY AND ENHANCED SCIENTIFIC REGARD. THAT THAT'S A COAT FOR THE BILL. SO WE WILL TALK ABOUT BEFORE WE MOVE THAT CONTRACT INTO PLACE. THE BILL AND THE REPORT LANGUAGE THAT ACCOMPANYS THE BILL, WHICH I WILL COME BACK TO BECAUSE I WILL PROVIDE UPDATES ON THAT AND THEN THERE WERE A NUMBER OF ISSUES WHERE CONGRESS EXPRESSED INTEREST AND SUPPORT FOR WHAT NIH IS DOING AND A NUMBER OF AREAS AND SOME OF THOSE ARE LISTED HERE SO WE'RE PLEASED TO HAVE OUR BUDGET IN PLACE AND ARE CAREFULLY SCOURING THE BILL TO UNDERSTAND THE EXPECTATIONS FOR US FOR THIS YEAR. ALSO, RECENTLY WE HAD A VERY IMPORTANT VISITOR FOR CAMPUS, THE PRESIDENT CAME ASK VISITED THE VACCINE RESEARCH CENTER AND HEARD ABOUT OUR EBOLA RESEARCH EFFORTS. YOU CAN SEE TONY FAUCI, SORT OF FUZZY IN THE BACKGROUND AND FRANCIS BEYOND HIM, THE PRESIDENT HEARING ABOUT EBOLA RESEARCH FROM DR. NANCY SULLIVAN. HE ALSO HAD AN OPPORTUNITY TO ADDRESS THE FOLKS HERE AT THE NIH WHICH WAS UPLIFTING AND HEARING ABOUT HOW MUCH IMPORTANCE HE PLACES ON BIOMEDICAL RESEARCH. SO SO TWO QUICK POLICY UPDATES AND I WANT TO DRAW YOUR ATTENTION TO THESE BECAUSE THESE ARE PROPOSED POLICIES THAT ARE NOW AVAILABLE FOR PUBLIC COMMENT. SO WE'RE REALLY SPEAKING TO GET PUBLIC COMMENT ON A COUPLE OF PROPOSALS FOR AROUND CLINICAL TRIAL DATA SHARING AND CLINICAL RESEARCH. SO THE FIRST PROPOSAL IS PROPOSED REGULATIONS WE HAVE PUT OUT THAT WERE REALLY REQUIRED BY A LAW THAT WAS ENACTED SOME YEARS AGO AND THE LAW BASICALLY REQUIRED THAT CLINICAL TRIALS BE REGISTERED IN CLINICAL TRIALS.GOV AND THAT SUMMARY RESULTS FROM THOSE TRIALS BE SUBMITTED INTO THE DATABASE AND OUR PROPOSED REGULATIONS PROVIDE CLARITY ABOUT THOSE EXPECTATIONS AND BASICALLY EXECUTE SOME OPTIONS THAT WERE PROVIDED WITHIN THE LAW FOR THE REQUIREMENT THAT WE CAN PUT FORWARD, SO THE LAW REQUIREDDED AS A MINIMUM THAT PHASE TWO AND THREE STUDIES FDA REGULATED MEDICAL PRODUCTS COMPRISE WITH THE RULES AND WE EXTENDED THAT TO NOT JUST APPROVED PRODUCTS BUT ALSO UNAPPROVED PRODUCTS SO YOU CAN IMAGINE A NEGATIVE TRIAL AND THE RESULTS OF THAT TRIAL ARE AS IMPORTANT TO MAKE PUBLIC AS A SUCCESSFUL TRIAL. SO THOSE--THE SCOPE OF THOSE PROPOSED REGULATIONS AS I MENTIONED IS FOR FDA REGULATED MEDICAL PRODUCTS AND PHASE TWO/THREE CHYLES AND WE DECIDED TO EXTEND THAT POLICY FOR PURPOSES OF NIH SUPPORTED TRIALS TO INCLUDE ALL OF OUR CLINICAL TRIALS IRRESPECTIVE OF PHASE OR WHETHER THEY WERE DESIGNED TO STUDY AN FDA REGULATED PRODUCT OR NOT. SO WE FUND QUITE A BIT OF OF STUDIES LOOKING AT BEHAVIORIAL INTERVENTIONS AND OTHERS WHERE WE WANT TO HAVE THAT DATA OUT THERE AS WELL. THIS IS A PRETTY HEFTY REGULATION AND AN IMPORTANT ONE AND SO I WOULD REALLY COMMEND IT TO YOU TO TAKE A CAREFUL LOOK AND PROVIDE COMMENTS TO US. THE COMMENT PERIOD PRESENTLY IS FEBRUARY 19th ALTHOUGH WE HAD A COUPLE OF REQUESTS TO EXTEND THAT AND WE'RE TAKING THOSE SERIOUSLY. THE SECOND PROPOSED POLICY ALSO RELATED TO THE CONDUCT OF CLINICAL RESEARCH AND OTHER HUMAN SUBJECTS RESEARCH IS A PROPOSAL THAT WE HAVE PUT FORWARD THAT WOULD REQUIRE A SINGLE IRB FOR MULTISITE STUDIES, I THINK WE ALL APPRECIATE THAT GETTING MULTIPLE IRBs TO REVIEW OUR PROTOCOL, CERTAINLY TAKES A LOT OF TIME. IT OFTEN TAKES CONSIDERABLE MONEY AND IT CERTAINLY TRIES OUR PATIENCE. IT DOES NOT INCREASE PROTECTIONS, AT LEAST I'M UNAWARE OF ANY DATA THAT IT INCREASE PROSTEBGZ FOR ANY INDIVIDUAL THIS IS STUDY, SOPHISTICATED SO WE PUT OUT A PROPOSAL OF COMMENTS STARTED OUTREACH OF FOLKS FOR INSTITUTIONS AND FOR STAKEHOLDER GROUPS AND THE LIKE TO ENGAGE IN CONVERSATION DURING THIS COMMENT PERIOD ABOUT THIS PROPOSAL. WE NOTE THAT THERE SHOULD BE AND MUST BE EXCEPTIONS TO ANY RULE AND THIS RULE IS NO EXCEPTION TO THAT. WE WILL PROVIDE EXCEPTIONS TO PERMIT LOCAL IRB REVIEW WHEN THAT IS REQUIRED OR TO DO VOICE WOULD BE IN CONFLICT WITH LAW. SO FOR EXAMPLE, MEDICAL DEVICES REQUIRE THERE WILL BA LOCAL IRB FOR TRIALS ON THOSE DEVICES. THERE ARE EXCEPTIONS WE ARE TRYING TO FORMULATE WELCOME COMMENTS ON IN THE CIRCUMSTANCE WHEN THEY'RE UNIQUE POPULATIONS. SO POPULATIONS THAT MIGHT HAVE VALUE THAT MIGHT NOT BE REFLECTED IN THE REVIEW BY SOME DISTANT IRB. SO COMMENTS FOR THAT ARE DUE ON JANUA AND THE NIH PROPOSAL - TO CONTRACTS AND GRANTS. YOUR SISTER COMMITTEE AS I MENTIONED, MET LAST WEEK IN THIS VERY ROOM. THEY HEARD PRESENTATIONS ON EBOLA AS WILL YOU TODAY. THEY DISCUSS PEER REVIEW MOSTLY ISSUES OF BI AS AND HOW TO INCREASE DIVERSITY THROUGH THE PEER REVIEW PROCESS, REPRODUCIBILITY, WHICH IS AN ONGOING IMPORTANT TOPIC FOR THE NIH. WE HEARD A FABULOUS PRESENTATION AND DIRECTOR ON GENERAL MEDICAL SCIENCES AND OTHER PRESENTATIONS AND WE ALSO HEARD WORKING GROUPS FROM FOUR ACTIVE WORKING GROUPS. TWO OF THOSE, THE NATIONAL CHILDREN'S STUDY, WORKING GROUP AND THE HELA WORKING GROUP AND I WILL GIVE AN UPDATE ON WHAT THEY REPORTED OF THE ADVISORY COMMITTEE TO THE DIRECTOR BECAUSE THEY BOTH RELATED--RESULTED IN ACTIONS AT THE NIH LEVEL. AND THEN LASTLY, FRANCIS AT THE ACD MEETING ANNOUNCED HE IS CREATING A NEW WORKING GROUP OF THE ACD AND THIS WORKING GROUP IS SPECIFICALLY LOOKING AT THE FUTURE OF THE LIBRARY OF MEDICINE. AS YOU MAY KNOW DON LINDBERGH, THE CURRENT DIRECTOR OF THE NATIONAL LIBRARY OF MEDICINE WILL BE RETIRING SO A SEARCH WILL BE GETTING UNDERWAY, BUT BEFORE THAT SEARCH GETS UNDERWAY DR. COLLINS THOUGHT THIS WOULD BE AN OPPORTUNE TIME TO THINK CAREFULLY ABOUT WHAT THE ROLE OF THE NATIONAL LIBRARY OF MEDICINE SHOULD BE IN THIS NEW DAY OF TECHNOLOGY AND INTERCONNECTEDNESS AND BIG DATA. SO IF HAVE YOU IDEAS OF FOLK WHO IS MIGHT POPULATE THAT WORKING GROUP, SEND THEM TO ME OR FRANCIS AND WE HOPE TO GET IT UP IN THE NEXT FEW WEEKS AND ERIC GREEN, DIRECTOR OF THE NATIONAL HUMAN GENOME INSTITUTE. ACD, SO THESE ARE THE ACDs, NUMBERS AND YOU WILL RECOGNIZE MANY OF THESE NAMES INCLUDING CATO LAURENCIN, SO HE DID GET APPRECIATION FOR THAT. ONE OF THE WORKS GROUPS THAT WAS PUT TOGETHER THIS PAST SUMMER, LED BY COLLEAGUES AT STANFORD WAS CHARGED WITH LOOKING VERY CAREFULLY AT THE NATIONAL CHILDREN'S STUDY WHICH HAS HAD A LONG AND TUMULTUOUS HISTORY. THE CHILDREN'S STUDY, IF YOU'RE NOT AWARE WAS PLANNED TO BE FOR PHASE ONE PILOT STUDY TEST AND PROCEDURES AND METHODOLOGIES AND THE IMMUNE STUDY THAT WAS ENVISIONED TO BE A LONGITUDINAL STUDY TO LOOK AT ENVIRONMENTAL INFLUENCES ON CHILDREN'S HEALTH THAT WILL LOOK AT--FOLLOW A HUNDRED THOUSAND KIDS FROM H21 AND THE IMMUNE STUDY HAS NOT YET BEEN INITIATED AND THERE'S BEEN A SUM OF MONEY THAT'S BEEN INVESTED IN THIS STUDY SINCE IT WAS FIRST PROPOSED IN 2000. THERE HAVE BEEN A NUMBER OF CONCERNS THAT HAVE BEEN ECHOED OVER TIME. THEY WERE CRYSTALLIZED IN A NATIONAL ACADEMIES REPORT LAST--THIS YEAR AND WHEN YOU RECEIVED THIS REPORT THIS PAST SUMMER, FRANCIS PUT THE CHILDREN'S STUDY ON HOLD AND CONVENIENCE WORKING GROUP LOOKING CAREFULLY NOT JUST TWEAKS AND EDGES BUT REALLY TO ANSWER THE QUESTIONS, WHETHER OR NOT THE CHILDREN'S STUDY AS CURRENTLY DESIGNED IS EVEN FEASIBLE. AND THESE ARE THE MEMBERS OF THE WORKING GROUP THESE PEOPLE HAVE PEDIATRIC EXPERTOOSE AND I HAVE NO PEDIATRICS EXPERTISE BUT I WAS AIAN A--A MEMBER OF THIS GROUP. THIS IS THE CHARGE LOOKING FORWARD, IF YES, WHAT SHOULD WE DO, IF NOT, WHAT SHOULD WE DO. AND WE PRESENTED THIS FINAL REPORT, ON LAST FRIDAY. THE CORE FUNDING OF THEIR DELIBERATIONS WAS THAT THEY UNANIMOUSLY CONCLUDED THAT WHILE THE GOALS OF ENVIRONMENTAL FACTORS AND CHILDREN'S HEALTH ARE EXTRAORDINARILY IMPORTANT AND SHOULD BE A PRIORITY, THE CHILDREN'S STUDY IS CURRENTLY OUTLINED IS NOT FEASIBLE. THEY WENT ON TO RECOMMEND THAT THE PROGRAM OFFICE BE DISSOLVED THAT THE AND THE SPECIMENS BEEN OBTAINED FOR THE FAMILIES PARTICIPATE INDEED THE VAN GUARD STUDY BE MADE AVAILABLE AT THE RESEARCH, RESOURCE BUT THAT THE VAN GUARD STUDY SHOULD NOT BE CONTINUED AND NOT COLLECT FURTHER DATA; THEY TALKED ABOUT--IT TOOK--THE CHILDREN'S STUDY IS A BIG COMPLICATED AND IT TOOK THE WORKING GROUP SOMETIME TO REALLY WRESTLE WITH THE ISSUE OF FEASIBILITY, AND ONCE THEY HAD CONCLUDED THAT THE STUDY WAS NOT FEASIBLE, AS CURRENTLY DESIGNED, THEY HAD EXTENSIVE CONVERSATIONS ABOUT, WELL IF NOT THAT, THEN WHAT? BUT THEY DID NOT BECAUSE OF TIME AND SOMEWHAT BECAUSE WE DIDN'T HAVE EXACTLY THE RIGHT EXPERTISE, THEY DID NOT PROPOSE SPECIFIC PASS FORWARD BUT RATHER OFFERED A NUMBER OF APPROACHES FOR OUR CONVERSATION AND THEY'RE LISTED HERE. SO THEY DID PROVIDE A STRONG EXPECTATION FOR US TO CONTINUE TO SUPPORT THE GOALS AS ORIGINALLY ARTICULATED TO UNDERSTAND THE ENVIRONMENT AND PEDIATRIC HEALTH AND INSURE THAT ANY NEW STUDIES SHOULD BE INFORMED BY ADVANCES IN TECHNOLOGY AND RESEARCH. SO FRANCIS HAD SEEN OBVIOUSLY THE REPORT SEVERAL WEEKS BEFORE IT WAS CONSIDERED BY THE ACD AS DID THE ACD AND HE ACCEPTED THE ACD FINDINGS AND IT'S RECOMMENDATIONS AND NAMED DR. DAVID MURRAY THE ASSOCIATE DIRECTOR FOR PREVENTION TO OVERSEE THE CHILDREN'S STUDY AS WE MAKE THIS TRANSITION AND WE WILL BE STARTING RIGHT AWAY TO FIGURE OUT WHAT NEXT AND DO THAT IN A TRANS-NIH FASHION. SO THAT'S THE IMPORTANT WORK OF ONE WORKING GROUP THAT WORKED OVER THE COURSE OF SIX MONTHS AND DID NOT BY THE WAY, HAVE THE REQUIREMENTS THAT YOU ALL ARE BOUND BY TO MEET FIVE TIMES, WHETHER IT'S WALKING IN AND OUT OF THE ROOM FIVE TIMES, THEY DID MEET FIVE TIMES BUT THEY DID NOT HAVE TO NOTE THOSE MEETINGS, ET CETERA. SO THE SECOND WORKING GROUP, I WANT TO SAY A WORD ABOUT IS THE HELA WORKING GROUP WHICH AS YOU KNOW AND EVERY LAB, BIOMEDICAL RESEARCH LAB IN THE WORLD AND LAST YEAR IN MARCH, RESEARCHERS IN GERMANY POSTED THE WHOLE GENOME SEQUENCE FROM A HELIX CELL LINE THAT WAS CONVEYED TO THE FAMILY THAT BECAME A HARMED AND YOU CAN SEE AT THE BOTTOM OF THE SLIDE THERE THAT JERI, LACKS, IS AS THOUGH HER MOTHER'S MEDICAL RECORDS HAD BEEN PUT OUT THERE TO SEE. THESE HAVE BEARING ON THE WORK WE SUPPORT SO WE GOT ACTIVELY ENGAGED RIGHT AWAY IN THE DISCUSSIONS AND REACHED OUT TO THE FAMILY TO ENGAGE WITH US IN CONVERSATION. WE DID HAVE AN OPPORTUNITY TO TALK TO THE FAMILY AND TO UNDERSTAND THEIR EXPERIENCE OF HAVING BEEN THROUGH MANY YEARS OF LEARNING THINGS ABOUT WHAT HAS HAPPENED WITH THESE CELLS THAT WERE TAKEN FROM THEIR MOTHER, GRANDMOTHER, GREAT GRANDMOTHER WITHOUT HER PERMISSION AND YET IN THIS SITUATION AND USING THE SITUATION OF HELIX CELLS NO ONE HAD SPOKEN OF LAWS. SO HOW CAN WE MOVE FORWARD IN A MUTUALLY RESPECTFUL WAY THAT WILL HONOR THEIR DESIRE WHICH INCLUDE BEING VERY, VERY DEDICATED TO MAKING SURE THAT HELIC CELLS AND HELA GENOME SEQUENCES ARE MAXIMALLY BENEFICIAL TO BIOMEDICAL RESEARCH. SO WE DID WORK ON AN AGREEMENT WITH THE FAMILIES AND PUBLISHED AN ARTICLE ABOUT THAT IN NATURE A YEAR AGO, YEAR AND HALF AGO. I MEAN AT THE SAME TIME JASON CURRY'S LAB IN WASHINGTON PUBLISHED THE SECOND GENOME, WHOLE GENOME SEQUENCE. THERE ARE NOW FOUR GENOME SEQUENCES THAT ARE AVAILABLE AND I'LL TELL BUT THAT SO THE AGREEMENT WITH THE FAMILY WAS THAT IF A RESEARCHER WANTS TO GET RESEARCH SEQUENCE YOU HAVE TO APPLY AND YOU MUST DEMONSTRATE IN YOUR APPLICATION THAT YOU WILL ABIDE BY THE TERMS OF THE DATA ACCESS AGREEMENT WHICH MEANS YOU WILL ONLY USE IT FOR BIOMEDICAL RESEARCH, YOU WON'T REACH OUT TO THE FAMILY, YOU WILL DISCLOSE ANY COMMERCIAL PLANS YOU MIGHT HAVE, YOU WILL TALK ABOUT YOUR AND IT'S NOT LISTED ON THE SLIDE, YOUR PLANS FOR SHARING WHAT YOU LEARN INCLUDING PUBLICATIONS AND PRESENTATIONS AND INCLUDE AN ACKNOWLEDGMENT TO HENRY RIETA LACKS IN YOUR PUBLICATIONS. WE PUT TOGETHER A HELA GENOME DATA ACCESS WORKING GROUP WHICH EVALUATES THESE QUESTIONS AND SUBMITS THEM BACK TO THE DIRECTOR. SO THAT HAS WORKED PRETTY L. WE'VE BEEN AROUND FOR A YEAR NOW. WE'RE NOW GETTING PROGRESS REPORTS BACK FROM THE FIRST DATA ACCESS, REQUEST THAT WE APPROVED WHICH IS QUITE HEARTENING TO SEE WHAT WORK HAS BEEN ACCOMPLISHED JUST IN THAT SHORT TIME BUT WHEN YOU PUT THE POLICY IN PLACE, WE WERE DEALING WITH A WHOLE GENOME SEQUENCE AND WE TALK TO THE FAMILY A LOT ABOUT HOW MUCH DATA WAS OUT THERE IN TERMS OF SMALL SNIPITS OF DNA, OR RNA SEQUENCE INFORMATION OR OTHER KINDS OF GENOME INFORMATION THAT WAS NOT A WHOLE GENOME AND WE AGREE THAT WE WOULD COME BACK TO THAT ISSUE AND WE LOOK AT IT IN DETAIL AFTER WE GET OUR PROCESSES IN PLACE. SO WE HAD A WORKSHOP IN MAY, HEARD FROM SCIENTISTS AT THE SYSTEM, THE FAMILY AND REALLY HEARD FROM THE FAMILY THAT THEY--THEY WANTED FOLKS TO HAVE RAPID ACCESS TO GENOMIC DATA, THEY DON'T WANT TO DELAY SCIENCE BUT THEY WANT TO KNOW WHAT'S GOING ON. SO THE HELA WORKING GROUP MADE A RECOMMENDATION TO THE ACD THAT WE FOCUS ON WHAT WE'RE LEARNING FROM HELA CELLS AND THE GENOME AND HAVE IT IN A SCIENTIFIC SESSION AS WELL AS LAY ACCESSIBLE MODE AS L. SO THAT ACD RECOMMENDATION WAS ACCEPTED AT THE LAST ACD MEETING BUT WE WANT TO HAVE AN OPPORTUNITY TO CONSULT WITH THE FAMILY BEFORE FRANCIS MADE THE FINAL DECISION ON THAT. SO WE DID HAVE AN OPPORTUNITY TO MEET WITH THE LACKS FAMILY AND TALK TO THEM ABOUT THE WORKSHOP, TALK ABOUT THE RECOMMENDATIONS FROM THE ACD, AND IT WAS A REALLY WONDERFUL MEETING. IT WAS LAST WEDNESDAY IN BALTIMORE WHICH IS WHERE THE FAMILY LIVES AND WE TALKED TO THEM ABOUT WHAT HAPPENED WITH HELA GENOME SEQUENCES, HOW THE DATA HAD BEEN ACCESSED AND USED. WE TALKED ABOUT THE PAPER WHICH INCLUDES A NEW WHOLE GENOME SEQUENCE AND PUBLISHED IN CELL LAST WEEK AND IT'S COOL ABOUT GENOME STRUCTURE WITHIN THE NUCLEUS, AND THEY ARE SUPPORTIVE OF THAT DECISION TO NOT EXTEND THE POLICY TO OTHER KINDS OF GENOMIC DATA AND TO SUPPORT THE SYMPOSIUM. THIS IS A PICTURE OF SOME OF THE WORKING GROUP. SOME WERE ON THE PHONE. RICK MYERS, BOB NUSSBALM AND RUSS ALMAN WERE UNABLE TO ATTEND IN PERSON BUT RICK MYERS WAS ON THE PHONE AND IN THE FRONT YOU SEE SHIRLEY, JERRY, DAVID, VERONICA AND KIMBERLY FROM THE LACKS FAMILY AND RENE JENKINS WERE THE ABLE CHAIR OF THE WORKING GROUP AND SHE'S ROTATING OFF THE ACD AND OFF THE HELA WORKING GROUP AND SO CLYDE WORKED OFF THE ACD AND ON TO THE SMRB IN QUICK CESSATION AND CLYDE AND I WILL TAKE OVER AS CAIRS OF THIS WORKING GROUP MOVING FORWARD. SO THAT IS SORT OF A QUICK ROMP THROUGH SOME SOME OF THE RECENT ACTIVITIES, Y'ALL MET A COUPLE OF MONTHS AGO, CAN YOU SEE THERE'S BEEN AN AWFUL LOT OF ACTIVITY HERE AT THE RANCH AND THEN LOOKING FORWARD TO THE DAY HERE WITH YOU. THANK YOU. >> CATHY, THANK YOU VERY MUCH. IS IT ANYONE HAVE ANY QUESTIONS YOU WOULD LIKE TO ASK AT THIS POINT? >> I HAVE A NOT A QUESTION BUT A COMMENT WHICH WAS REGARDING ABOUT THE CLINICAL CAT DATA. ONE OF THE THINGS WE'RE STRUGGLING WITH IS GETTING THE DATA OUT THERE IN A TIMELY FASHION, AND ONE OF THOSE IS DEALING WITH THE NEGATIVE STUDIES, IT'S HARD ENOUGH TO GET POSITIVE STUDIES DATA GOING THROUGH THE REVIEW PROCESS, BUT NEGATIVE STUDIES BECOMES ALMOST UNBEARABLE BURDEN AND YOU KNOW WE THINK IT'S IMPORTANT TO HAVE A SOLUTION TO THIS, WHETHER THERE IS A NEW PUBLICATION OR SOMETHING THAT WOULD SUPPORT, YOU KNOW GETTING MUCH OF THIS CLINICAL DAT OUT THERE IN AN EXPEDITIOUS FASHION. I THINK CLINICALTRIALS .GOV IS A REAL SOLUTION TO THIS PROBLEM AND THE TROUBLE IS WHETHER OR NOT THE FORMAT OF CLINICALTRIALS.GOV, IS THE EASY UTILIZATION OF THAT DATA SO FROM MY PERSPECTIVE, I WOULD LIKE TO SEE NIH STAFF LOOKING AT CLINICAL TRIALS.GOV WHEN THEY GET AN APPLICATION FOR FOR CLINICAL TRIAL AND SEE HOW IT FITS INTO THE PAN OPEN MEETING OLDER PEOPLEY OF THINGS OUT THERE, I'M HOPING IF WILL BE I USEFUL RESEARCH ITSELF AND NEGATIVE CAN HAVE JUST AS MUCH IMPACT AS POSITIVE AND THEY'RE HARDER TO GET PUBLISHED. ATHER THING I WOULD ADD IS THAT THERE IS AN INDUSTRY AND TAKING THE LEAD HERE AN EFFORT TO MAKE PATIENT LEVEL DATA FROM CLINICAL TRIALS ACCESSIBLE FOR SECONDARY RESEARCH, REALLY. AND GSK AS DONE THIS, MET TRONNIC HAS DONE THIS IN A LIMITED WAY, SO WE ALONG WITH A NUMBER OF OTHER RESPONSES ASK THE IOM TO LOOK AT THIS ISSUE AND WE'RE SPECTING A REPORT BACK TO THEM FOR TIMING ON THE BENEFITS, RISKS AND SORT OF THE MECHANISMS OF MAKING POTENTIALLY CONSIDERING FOR MAKE THANKVING KIND OF DATA AVAILABLE, SO I'M GETTING CLINICAL TRIALS.GOV UP WITH AGGREGATE DATA IS AN IMPORTANT STEP BUT WE HAVE ANOTHER CHALLENGE RIGHT IN FRONT OF US. >> OTHER QUESTIONS OR COMMENTS? >> I HAVE A COMMENT. >> GO AHEAD. >> THIS IS A NOTION OF SINGLE IRB FOR MULTICENTER STUDIES. HAVE SOME HISTORY AND I WILL JUST SEND THE DIFFERENCE, IT'S THURN QUIT ET AL, IT'S CALLED STREAMLINING IRB REVIEW AND MULTISITE TRIALS THROUGH SINGLE STUDY IRB COOPERATIVE AGREEMENTS, EXPERIENCE OF THE BETA KARA TEEN AND EFFICACY TRIAL FOR CARROT FOR CONTROL CLINICAL TRIALS, 2002 AND IT WAS VERY HELPFUL GUIDANCE FROM NIH AND NCI, AND IT WAS VERY EXPEDITIOUS ONCE WE LEARNED THIS WAS FEASIBLE AND WE DID TO THE LETTER OF THE LAW AND IT'S CERTAINLY SAVED TREMENDOUS AMOUNT OF REG EDITING AS EVERY INSTITUTION HAS THE SECRET TO DO THAT ON THESE MULTICENTER STUDIES. SO I'M SURE THERE ARE MANY EXAMPLES BUT THAT'S A GOOD ONE, INVOLVED SEVEN DIFFERENT INSTITUTIONS AND SUBCONTRACTS OF EACH OF THEM. THE SECOND ONE IS ABOUT DATA SHARING OR SO CALLED NEGATIVE RESULTS OR POSITIVE RESULTS THAT ARE NOT CARRIED FORWARD FOR A VARIETY OF REASONS INCLUDING PRIORITIES AND INVESTMENTS AND SO FORTH. THERE'S ANENTITY CALLED TRANSMART, TRANSMART FOUNDATION, I HAPPEN TO BE THE CHAIR OF THE BOARD PRO BONO. IT IS A PUBLIC PRIVATE PARTNERSHIP. FDA IS ENGAGED IN THIS, FIVE DIFFERENT UNITS IN THE FDA HAS INSTALL #-DED THE TRANSMART PLATFORM AND WE THIS SHOULD DO MORE TO CONNECT WITH NIH. THIS INVOLVES MULTIPLE PHARMACEUTICAL COMPANIES AND DATA COMPANIES AS WELL AS UNIVERSITY OF MICHIGAN, JOHNS HOPKINS, HARVARD MEDICAL SCHOOL GROUPS AND OTHERS IN EUROPE. AND EVEN A PLACE IN JAPAN. SO IT'S A GLOBAL DEVELOPMENT AND IT HAS TWO PARTS. ONE IS TO BRIEFLY ADVANCE THE ANALYTICS FOR DATA ANALYSIS AND SECOND IS TO OBTAIN DATA SETS THAT MIGHT BE VALUABLE TO OTHER COMPANIES AND CERTAINLY TO ACADEMICS AND RESEARCH EN--STRATEGIES TUITIONS IN DESIGNING THEIR STUDIES AND FIGURING OUT WHETHER THERE ARE NEW OPPORTUNITIES OR OPPORTUNITIES THEY THINK ARE GOOD BUT ALREADY BEEN ADEQUATELY EXPLORED WITHOUT EXPECTED FINDINGS. SO HAPPY TO SHARE INFORMATION ON ALL OF THAT. >> GREAT, THANK YOU. >> GIL, THANK YOU VERY MUCH, ANY OTHER QUESTIONS? CATHY THANK YOU SO MUCH, IF ANYTHING ELSE COMING UP, POINT TO IT. >> LET'S TURN THIS PART OF THE MEALING OVER TO MICHAEL TO LEAD. >> THANK YOU. I THOUGHT ABOUT STAYING IN MY CHAIR BECAUSE THE PODIUM HAS A CERTAIN LEVEL OF FORM ATITY BUT I'M GOING TO STAND UP HERE BECAUSE IT'S EASIER TO CHANGE THE SLIDES AND WE'RE--I'M GOING TO PRESENT AN OVERVIEW OF WHAT THE COMMITTEE, THE SUBCOMMITTEE'S BEEN DOING AND THE DISCUSSION IF YOU LOOK AHEAD AT THE AGENDA, OPEN DISCUSSION WILL BE AT 1:30 SO I DOLL MY BEST TO KEEPON TIME AND RUN THROUGH AND THIS IS ENTITLED SOMETHING LIKE PRELIMINARY FINDINGS AND RECOMMENDATIONS AND I SAY THAT WE'VE GOT PRELIMINARY FINDINGS. RECOMMENDATIONS MAY BE TOO STRONG A WORRIED OF WHERE WE ARE AT THIS POINT AND TO SOME EXTENT, I WOULD SAY AS AN OPENING THAT THIS GROUP AND WHAT IT'S BEEN CONSIDERING REMINDS ME A LITTLE BIT OF MY ACADEMIC LIFE OF A CURRICULUM MEETING. AND YOU GET PEOPLE IN A ROOM, 50 PEOPLE AND EVERYBODY THINKING THEY KNOW EXACTLY WHAT TO TELL THE CURRICULUM WHEN THEY'RE LOOKING AT ONE SMALL PIECE OF IT. AND THE INTERESTING THING, I HAVE TO SAY SOMETIMES INTIMIDATING THING WHAT THIS GROUP HAD TO DO WAS TO STEP BACK AND LOOK AT THE WHOLE PICTURE AND WE MAY HAVE HAD IDEAS ABOUT HOW WE COULD MAKE THIS MUCH MORE STREAMLINE AND MUCH MORE EFFICIENT AND WE'RE STILL PUSHING HARD ON THOSE IDEAS, BUT I GUESS WHAT I WOULD SAY AT THE OUTSET IS WE'RE FINDING OUT JUST HOW COMPLICATED THE PROCESS AS BECOME. THE LARGE IS THEY'RE INTIMIDATING ITSELF, THEY'VE ASKED US, THE SMRB TO OPTIMIZE THIS PROCESS OF REVIEWING AWARDING AND MANAGING GRANTS IN A WAY THAT DOESN'T DRIVE EVERYBODY CRAZY, THAT MAXIMIZES THE TIME, THE RESEARCHERS CAN DEVOTE WHILE MAINTAINING PROPER OVERSIGHT AND IF THERE'S A COMMON THING WE HEAR ABOUT FROM OUR COLLEAGUEWHERE THINGS ARE THESE DAY SYSTEM THAT MAYBE SIMPLY PUT, THERE ISN'T ENOUGH TIME TO THINK ANYMORE. SPENDING SO MUCH TIME TO FUND THEIR RESEARCH THAT THEY'RE NOT TAKING THE TIME TO THINK. SO, WHAT COULD WE DO, HOW COULD NIH STREAMLINE THE PROCESS TO SHORTEN THE TIME FROM WHEN YOU FIRST SUBMIT A GRANT TO WHEN THE FUNDS ARE ALLOCATED AND WHAT BED WE DO TO HELP NOT ONLY THE APPLICANTS BUT THEIR INSTITUTIONS, COUNCIL MEMBERS AT NIH STAFF, TO MAKE THEIR LIVES EASIER WHEN SOMETHING HAS BECOME IN MANY WAYS AN OVERWHELMING PROCESS THAT'S BEEN OVERWHELMED, IF SOMETHING ELSE BY THE NUMBERS INVOLVED. SO THERE'S THE WORKING GROUP, I CHAIR IT, THAT'S PRETTY LOOSE TITLE THERE. EVERYBODY HAS PARTICIPATED IN VERY SUBSTANTIVE WAY. NORMA ALREADY LAUDED GILFOR HIS PARTICIPATION OVER THE YEARS AND OVER THE YEARS HE'S BEEN ACTIVE IN THIS. AND I THINK ONE TIME WHEN YOU CALL INDEED FROM SPAIN. AND THE ADVANTGE OF THAT WAS THE CONNECTION IF YOU RECALL IT WASN'T TERRIBLY GOOD, SO WE COULD PRETEND WE COULDN'T HEAR HIM WHEN WE DIDN'T LIKE WHAT HE WAS SAYING BUT TRUE TO FORM, HE WROTE EVERYTHING DOWN THAT HE THOUGHT WE SHOULD HEAR AND SENT IT TO US LATTER. THE FEDERAL AND NONFEDERAL MEMBER VS BEEN CONTRIBUTING SUBSTANTIVELY AND EQUALLY THROUGHOUT ALL OF OUR MEETINGS. SO HERE'S THE CHALLENGES THAT WE HAVE TO ADDRESS. THE TIME FROM APPLICATION TO AWARD FROM GRANT CAN TAKE MORE THAN A YEAR. THE MEMBER OF APPLICATIONS RECEIVED CONTINUES TO ARISE INCREASING THE PEER REVIEW BURDEN AND FOR THOSE OF YOU YOU MAY RECALL, THAT THERE'S AN ARTICLE HERE ENTITLED RETHINKING PEER REVIEW. RICHARD NAKAMURA WHO HELPED US A LOT AND PARTICIPATED AND IS GOING TO BE HERE TODAY, I THINK, IS QUOTED THROUGHOUT THIS, BUT THERE'S A GRAPHIC. AND THE GRAPHIC SHOWS IN 1998 THERE WERE 41,000 APPLICATIONS AND CHANGE TO NIH AND THEY INVOLVED 5800 REVIEWERS. IN 2014 THERE WERE 86,540 APPLICATIONS INVOLVING 15,884 REVIEWERS. SO RICHARD SAYS THIS, THAT THE SYSTEM IS CLOSE TO BREAKING, I THINK SOME OF THE WORK BEING GROUP WOULD SAY IT'S ALREADY AT THAT POINT BUT JUST TO GIVE YOU AN IDEA OF THE NUMBERS INVOLVED. SO WHEN I SAID AT THE OUTSET THAT IT'S EASY FOR SOME OF US, TO THINK WE UNDERSTAND THE PROCESS AND WANT TO RECOMMEND CHANGES THAT WILL MAKE IT MORE EFFICIENT, WE'RE CONFRONTED REGULARLY BY THE FACT THAT THERE'S ALMOST 86,000 GRANTS THAT COME IN IN 2014. THE BUDGET UNCERTAINTY MAKE ITS DIFFICULT TO MAKE AWARD DECISIONS AND IT RESULTS IN A BOTTLENECK AT THE END OF THE FISCAL YEAR. INVESTIGATORS SPEND SIGNIFICANT TIME, EMPHASIS ON SIGNIFICANT APPLY FOR GRANTS FOR RESEARCH PROJECTS AND LESS TIME TO ACTUALLY DO THE WORK AND MORE IMPORTANTLY AS I SAID BEFORE, LESS TIME TO THINK ABOUT WHAT THEY MIGHT WANT TO DO. SO I'M GOING TO BREAK THIS DOWN AND I WILL CONSIDER ALL OF THESE POINTS AND A REAL LITTLE BIT MORE DETAIL NOW AND WE WILL DISCUSS IT AT ANY LENGTH YOU WANT, LATER, I GUESS IT'S RIGHT AFTER LUNCH, CONSIDER WAYS IT'S BEING FUNDING CENTERS, REDUCE THE NUMBER OF GRANTING CYCLES PER YEAR, FROM THREE-TWO. WE WILL TALK ABOUT WHY WE'RE CONSIDERING THAT. PROPOSE THAT NIH SPENDING AUTHORITY BE EXTENDED BEYOND THE FISCAL YEAR, FUND PRINCIPAL INVESTIGATORS RATHER THAN PROJECTS, AND DEVELOP AND EMPELEMENT PRE-APPLICATION STREAMLINES PROCESSES. WE WILL TALK THROUGH EACH OF THESE IN THE NEXT FEW MINUTES BUT THESE ARE WHAT WE DEFINE AS MAJOR CHANGES AND MAYBE YOU'LL SEE A BIT MORE, WHY WE DEFINE THEM THAT WAY WHEN I WALK THROUGH THEM. WE ALSO CONSIDERED A LARGE NUMBER OF OTHER CHANGES AND I--THERE'S IRONY WHEN WE HAD THIS LONG LAUNDRY LIST OF TOPICS, WE ASKED A WORKING GROUP TO USE THE SCORING SCALE OF ONE TO NINE AND WE ALL RECOGNIZE THAT, AND A SIGN OF IMPORTANCE AND WITH THAT WE CAME UP WITH A PREVIOUS SLIDE OF THE MAJOR CHANGES, BUT WE HAVE ALSO DISCUSSED A NUMBER OF OTHER THINGS AND SOME OF THEM ARE EASY AND UNDERWAY FOR EXAMPLE, THE APPLICATION PROCESS ITSELF CAN BE TORTUOUS, THE IMPROVEMENTS TO GRANTS.GOV ARE UNDER WAY, PEER REVIEWERS SPENT A LOT OF TIME TALKING ABOUT THIS. WE NEED MORE, THOUGH I JUST TOLD YOU THERE WAS ALMOST 16,000, HARD TO KNOW YOU WILL FIND MORE IF YEAR GOING TO FIND MORE INCLUDING THE USE OF INTRAMURAL SCIENCE AND WE APPRECIATE ALL THE STUDY SECTIONS TO USE TECHNOLOGY IN A PRODUCTIVE WAY TO MAKE IT EASY FOR PEOPLE TO PARTICIPATE. AND REVIEWER TRAINING AND CONSISTENCY IS OF OBVIOUS IMPORTANCE. HAVING REVIEWERS ALMOST 16,000 WITH A FAIR NUMBER OF NEW ONES IS A RECIPE THAT CAN BE HELPED BY REVIEWER TRAINING. IT DOESN'T SAY IT HERE, BUT I'M NOT COMPLAINING BECAUSE I FLEW ACROSS THE COUNTRY AND GOT HERE LATE LAST NIGHT, BUT AS I SAID TO LARRY SCHAPIRO THIS MORNING WHEN I SAW HIM EATING A BANANA, I PROBABLY SHOULD HAVE GRABBED ONE IN HOTEL, KNOWING FULL WELL THERE WOULDN'T BE ANYTHING TO EAT HERE. I THINK IT SOUNDS TRIVIAL BUT WE HAVE TO TREAT THE REVIEWERS BETTER, NOT JUST LETTING THEM DO THIS FROM THEIR OFFICES BUT ACTUALLY MAKING A LITTLE EASIER FOR THEM TO COME AND DO THE WORK THAT NEEDS TO BE DONE. >> [INDISCERNIBLE]. >> SO I THINK THE RECOMMENDATION IS MORE BANANAS AND MORE OF A BANANA FUND. SO LET'S CONSIDER WAYS OF SPEEDING THE FUNDING DECISION MAKING BY THE INSTITUTE CENTERS AND INSTITUTES AND CENTERS AND INSTITUTES AND CENTERS. SORRY. SO THE BUDGET TIMES EFFECTS DECISION TIMING. AWARDS TEND TO BE GIVEN OUT LATER IN THE YEAR AND WE HEARD A LOT FROM FEDERAL MEMBERS ABOUT THE FOURTH QUARTER CRUNCH. IC DIRECTORS RETAIN APPLICATIONS FROM EARLIER CYCLES WHILE AWAITING BUDGET APPROPRIATIONS. SO EITHER PROSEATURAL CHANGES THAT COULD MAKE THIS PROCESS FASTER AND MORE EFFICIENT. WE'VE LISTENED TO A NUMBER OF OTHER AGENCIES AND PRIVATE FUNDING AGENCIES AND WE'VE HEARD ABOUT PROVIDING PARTIAL FUNDING FOR SOME GRANTS EARLY IN THE FISCAL YEAR WITH FULL FUNDING CONTINGENT ON A FINAL NIH BUDGET. I AM SURE YOU WILL HEAR IN THE DISCUSSION FROM BOTH SIDES, FEDERAL AND NONFEDERAL MEMBERS OF HOW THIS COULD HELP. THE PROBLEM IS WHAT LEAVES CONSIDERATION IS INACCURATE BUDGET PREDICTIONS COULD LEAD TO INADEQUATELY FUNDED PROJECTS. IT'S POTENTIAL OUTCOME OF PARTIAL FUNDING FOR SOME GRANTS EARLY IN THE FISCAL YEAR. REDUCE THE NUMBER OF GRANTS CYCLES PER YEAR FROM THREE-TWO. SO CURRENTLY AS YOU KNOW THERE ARE THREE CYCLES, THE TIME FOR THE APPLICATION CAN BE MORE THAN A YEAR, APPLICATIONS REVIEWED IN THE SEPTEMBER COUNCIL MAY NOT BE FUNDED TILL THE FOLLOWING FISCAL YEAR BECAUSE OF THE BUDGET UNCERTAINTY. SO IF WE REDUCE THE NUMBER OF GRANT CYCLES TO TWO, IT'LL ALLOW TIME, TIME IN THE COUNCIL MEETINGS TO AVOID THE FISCAL YEAR BUDGET CRUNCH. INTERESTINGLY NSF FOUND THAT BY REDUCING THE CYCLES, THEY ACTUALLY GOT FEWER APPLICS. MOST OF WHAT NIH DOES IS EXPERIMENTAL. I REALIZE THERE'S SOME THEORY IN IT MOST OF IT EXPERIMENTAL, WE DON'T KNOW WHAT THE OUTCOME WOULD BE, IF NSF HAS ANYTHING TO DO WITH IT, IF IT'S ANALOGOUS TO WHAT WE HEAR, MAYBE THAT NUMBER OF 86,000 GRANTS WOULD ACTUALLY GO DOWN. WE'VE DEBATED WHETHER THIS WOULD BE THE CARE AT NIH OR NOT. >> THE COUNCIL MEETING LIKELY IN SEPTEMBER COULD BE USED FOR A NUMBER OF IMPORTANT--IN OTHER WDS EVEN THE COUNCIL DOESN'T HAVE TIME TO THINK LIKE THE SCIENTISTS DON'T HAVE TIME TO THINK AND IN EFFECT, WE WOULD BE GIVING THEM TIME TO THINK, CONCEPT CLEARANCE, PRIORITY SETTING, ET CETERA. HERE IT'S AS YOU CAN SEE THE THREE CYCLES AND THE MOST IMPORTANT COUNCIL MEETINGS THAT DETERMINE THE ULTIMATE AWARDING OF THE GRANTS AND YOU CAN SEE THE AWARD WHERE THE AWARDS ARE MADE IN RED, AND IT IS THAT LAST ONE CYCLE THREE WHERE THE CRUNCH AND CREATED. WHAT TWO WOULD LOOK LIKE IS JUST SHOWN, JUST FOR DISCUSSION SCHEMATICALLY SHOWN HERE WITH TWO CYCLES AND THE THIRD BEING USED AS I SAID PREVIOUSLY FOR THE COUNCIL AND THE DIRECTORS TO STEP BACK FOR A MINUTE AND THINK ABOUT NEW INITIATIVES AND HOW WELL WE'RE DOING WITH THE CURRENT ONES. OKAY SO AS I MENTIONED, IT'S UNCLEAR WHETHER THE CYCLES WOULD CHANGE THE WORK LOAD FOR THE SROs AND REVIEWERS, IT'S UNCLEAR WHETHER THE EXTRAMURAL COMMUNITY WOULD RESPOND BY SUBMITTING FEWER APPLICATIONS, SO AS I SAID, THAT'S WHAT WAS OCCURRED AT NSF. ONE POTENTIAL WAY TO ALLEVIATE THE BURDEN MIGHT BE TO STAGGER REVIEWS OF CERTAIN MECHANISMS AND WE CAN DISCUSS THAT IN MORE DETAIL ANYTIME, BUT CERTAINLY THIS AFTERNOON. THIS IS ONE THAT SOME OF US, WOULD BE ME INCLUDED FEEL STRONGLY ABOUT THAT, TO PROPOSE THE NIH SPENDING AUTHORITY BE EXTENDED BEYOND THE FISCAL YEAR FELT OTHER AGENCY VS SPENDING AUTHORITY BEYOND ONE FISCAL YEAR. WE THINK THAT THAT THIS GIVEN HOW SCIENTISTS THOUGHT ABOUT IT FUNDED THAT THIS WOULD MAKE GREAT SENSE FOR NIH. BUDGETARY CONSIDERATIONS OFTEN CAUSE A DELAY IN FUNDING DECISIONS RESULTS IN THIS BOTTLENECK THAT I'VE ALREADY MENTION SAID. IF WE COULD EXTEND THE FUNDING AUTHORITY BEYOND THE FISCAL YEAR, IT WOULD ALLOW THE ICs TIME TO SPREAD THEM OUT MORE EVENLY THROUGHOUT THE YEAR. SO, PERHAPS NO PUN INTENDED A BIG HILL TO CLIMB HERE, EXTENSION OF NIH FUNDING, SPENDING AUTHORITY WOULD REQUIRE CONGRESSIONAL ACTION. I CAME FROM A GENERATION THAT ASKED A LOT OF QUESTIONS, I STILL LIKE TO THINK I DO THAT. I THINK MY CONCLUSION IS IF I DON'T ASK--IF WE THINK THIS IS A GOOD IDEA AND WE DON'T ASK THEM, THEY'RE NOT GOING TO DO IT JUST BECAUSE THERE'S SOMEONE OCCUPY WASHINGTON HILL THINKS THIS IS A GOOD IDEA. WE WILL HAVE TO ASK THEM. NOW OTHER FEDERAL AGENCIES WITH THIS AUTHORITY INDICATE IT DOES--IT DOES LITTLE TO LESSEN THE WORK LOAD AND IT SOMETIMES RESULTS IN THE LOSS OF FUNDS WE HEARD FROM THE LIPPEDDA BLEVINS AT THE D. O. E. THAT THEY PULL FUNDING BACK IN THE AUTHORITY, AND SO THAT YOUR PLANS PROJECTED OUT OVER A TWO YEAR SPENDING AUTHORITY, HAD BEEN INTERRUPTED BY POLITICS ON THE HILL. SO AS I'M SURE, WE FEEL STRONGLY ABOUT THIS IS A POETICCATIVE THING FOR THE NIH OR RESEARCH COMMUNITY IN GENERAL. FUND PRINCIPAL INVESTIGATORS RATHER THAN PROJECTS, I KNOW THAT SOUNDS GOOD, AND IT SHOULD BE SOMETHING THAT WE LOOK INTO, AND INVESTIGATORS SPENDS A LOT OF TIME AS I SAID ALREADY, A FEW TIMES, RIGHTING PROPOSALS LEADING LESS TIME TO ACTUALLY DO THE WORK. WE COULD FUND INVESTIGATORS RATHER THAN SPECIFIC PROJECTS IT WOULD ALLOW INVESTIGATORS TIME TO ESTABLISH RESEARCH PROGRAMS. WE ALREADY AT THIS TIME THAT THE WORKING GROUP HAS BEEN MEETING THAT MANY ICs HAVE PILOTED GRANT MECHANISMS THAT FUND INDIVIDUALS RATHER THAN PROJECTS, THEIR PILOT PROJECTS THAT THE JURY IS STILL OUT ABOUT HOW WELL THEY'RE WORKING BUT OTHER ASPECT OF NIH COULD DO IS PROVIDE LONGER AWARDS GIVING MORE PEOPLE TIME TO DEVELOP IDEAS ESSENTIALLY COULD HAVE A POTENTIAL IMPORTANCE. AGAIN A TOPIC SOME OF US COULD USE TO STREAMLINE AND SPEED UP THE PROCESS IS TO DEVELOP AND IMPLEMENT A PREAPPLICATION STREAMLINING PROCESS, IT WOULD SPEED IT UP. THERE THERE ARE OPINIONS THAT SAY THIS WOULD ACTUALLY SLOW IT DOWN BUT THE TIME FROM SUBMISSION TO AWARD. --THE TIME SPENT WRITING IS ENORMOUS. NIH FOR SOME MECHANISMS COULD PROVIDE PREAPPLICATION THAT UNDERGOES PEER REVIEW THERE ARE PROGRAMMATIC REVIEW, I'M SURE WE WILL HEAR ABOUT THAT TO DETERMINE WHETHER A FULL APPLICATION IS WARRANTED, EVEN IF IT IS THE END, THE WHOLE PROCESS FROM PREAPPLICATION TO THE SEND LONGER IF THE PREAPPLICATION HEALTH INVESTIGATOR NOT RESPOND A HUGE AMOUNT OF TIME DEVELOPING THE IDEA TPURGTSER IT DOESN'T HAVE A LOT OF MERIT BUT AT LEAST IN THE VIEW OF THE INNERI SHALL PREAPPLICATION THAT THEY COULD GO BACK AND DEVELOP THAT IDEA FURTHER. SO THE CONSIDERATIONS, IT'S UNCLEAR WHETHER NIH HAS THE AUTHORITY TO DO THIS; AGAIN I COME BACK TO, WE SHOULD ASK THE QUESTION, AT LEAST AND PUSH IT TO COMPLETION AND AS I'VE ALREADY MENTIONED THIS COULD INCREASE THE TIME FOR REVIEW. SO THOSE ARE AS I SAID PRELIMINARY FINDINGS, I STOPPED SHORT OF CALLING RECOMMENDATIONS, THERE'S A LOT TO TALK ABOUT AS I HOPE BUT I'M CERTAIN BASED ON THE WORKING GROUPS DISCUSSION THAT THERE WILL BE NO LACK OF DISCUSSION AT 1:30 WHEN WE RETURN TO THIS BUT BEFORE WALTER COMES TO TALK TO US ABOUT WHAT HIS INSTITUTE HAS BEEN DOING I SHOULD AT LEAST ASK WHETHER THERE'S COMMENTS OR QUESTIONS RIGHT NOW? WE'RE ONLY SLIGHTLY OFF SCHEDULE. OKAY. THANK YOU. I AM SURE WE WILL HEAR MORE. >> GREAT, WELL, PLEASURE TO BE HERE, I'M WALT FROM THE-- >> RECORDING: SOMEONE HAS JOINED THE CONFERENCE. >> VERY INTEREST INDEED WHAT THIS COMMITTEE DOES, CLEARLY I'VE BEEN AT NINDS ABOUT SEVEN YEARS NOW ANDAIN TIMES IT FEELS LIKE WE'RE TRYING TO FIGHT A WAR WITH BOTH HANDS TIED BEHIND OUR BACK AND TREME LINING THE PROCESS AND MAKING THEM MORE REASONABLE, I THINK HAS A LOT OF BENEFITS AND I THINK ALSO FOR THE RESPECTS OF THE ITSELF ITSELF, ONE OF THE BIG PROBLEMS I WORRY ABOUT IS PEOPLE READING THINGS WE SEND OUT AND RULES WE TELL THEM THEY HAVE TO ABIDE BY AND IT REFLECTS POORLY ON US AND OUR STAFF IS DEMORALIZED WHEN THEY HAVE TO FOLLOW THROUGH ON THINGS THAT DON'T MAKE A LOTS OF SENSE. SO A COMMITTEE LIKE THIS, IT CAN LOOK AT WHAT THE PROBLEMS ARE I THINK ARE INEDIBLY VALUABLE TO THE INSTITUTE ON MULTIPLE FRONTS. SO I WAS ASKED, I GUESS STORY PROBABLY CAME AND TALKED TO YOU ABOUT EFFORTS THAT WE WERE TRYING TO PUT IN PLACE TO MOVE FORWARD IN TERMS OF FUNDING AWARDS, CLOSEST POSSIBLE TO WHEN THE COUNCIL OCCURS AND AND I WILL SHOW YOU DATA THAT OUR PEOPLE PUT TOGETHER AND THEY BASICALLY WENT INTO QVR AND LOOKED AT INSTITUTES AND THEY SAMPLED A COUPLE OF YEARS AND COUNSEL ROUNDS AND PUT THE COUNCILS HERE, IT'S THERE, IT'S NOT ACROSS THE BOARD NIH DATA DONE OFFICIALLY SO IT'S--I GOT THIS KIND OF MORE UNOFFICIAL DATA COMING OUT OF NINDS. AND SO, TAKE THAT AS A CAVEAT. SO, THE SO HERE'S THE DATA WE COULD FIGURE OUT FROM RECEIPT OF THE GRANT TO SUMMARY STATEMENT SO THIS IS CSR COMPONENT. SO THAT'S QUITE FLAT IN MULTIPLE INSTITUTES. IT'S A LITTLE VARIATION BUT NOT MUCH. A BIG VARIATION COMES IF YOU LOOK AT THE MEDIAN FROM SUMMARY STATEMENT, FROM THE GRANTS BEEN REVIEW, THE SUMMARY STATEMENT COMES OUT AND THAT'S CERTAINLY WHAT WE USE AS A DIRECTOR LOOKING AT THE SUMMARY STATEMENTS, A BIG PLAY ON WHAT WE FUND. AND THERE YOU CAN SEE VARIABILITY AMONG THE INSTITUTES AND IT'S A GOOD THING BECAUSE IT HELPS YOU EXPLORE WHAT THE REASONS FOR AND PERHAPS MAYBE THERE ARE SOME THINGS THAT COULD BE LOANED FROM THE DIFFERENT PRACTICES, THAT MIGHT BE HELPFUL SO I'M NOT SURE IF STORY KNEW THIS WHEN SHE LEFT, BUT I THINK THIS DATA CAME OUT AFTERWARDS, BUT IT SEEMS LIKE WE'RE DOING ACTUALLY PRETTY WELL. SO, WHETHER NIH DATA ANALYSIS WHICH ARE THE SAME THING, I'M NOT POSITIVE BUT I'LL TELL YOU A LITTLE BIT ABOUT WHAT MORE OF THIS DATA AND WHAT WE DO WHICH MIGHT EXPLAIN SOME OF IT. THEN WE LOOKED AT DIFFERENT COUNCIL ROUNDS AND THAT'S ALSO INTERESTING BECAUSE THE MUCH FLATTER AT THE MINICOUNCIL THAN THEY ARE AT THE JANUARY AND PARTICULARLY THE OCTOBER COUNCIL. AND OTHER ICs DO THINK DIFFERENTLY WHICH ACCOUNTSS FOR THIS. THE MAY COUNCIL YOU GENERALLY KNOW WHAT YOUR BUDGET IS BY MAY, SO MIGHT ACCOUNT FOR YOU KNOW YOU HAVE SOME THINGS THAT YOU ARE THINKING ABOUT, YOU'RE NOT SURE WE CAN DO, YOU FINALLY GET YOUR BUDGET AND THEN THINGS FEEL COMFORTABLE AND START MOVING THINGS QUICKLY. OCTOBER IS A BIG SRAOERT IN OCTOBER AND PART OF THAT, I THINK A LOT OF THAT IS THE FACT THAT A LOT OF COUNCIL PROBABLY FUNDING FROM THE NEXT YEAR'S MONEY IN THE OCTOBER COUNCIL. WE DO VERY WELL IN OCTOBER COUNCIL BUT WE FUND ALMOST EVERYTHING FROM THE PRIOR YEAR MONEY IN OCTOBER COUNCIL. SO FOR US, WE ARE CLEANING THE BOOKS AND BASICALLY, SO EVERYTHING WE FUNDED AS OF LAST OCTOBER CAME FROM NY14 FUNDS WITH THE EXCEPTION OF ABOUT 25 MILLION DOLLARS. IT'S GENERALLY ABOUT 20. THIS YEAR IT WAS ABOUT 25. SO IN OCTOBER WE'RE TRYING TO BASICALLY USE UP ALL OF OUR FY14 MONEY AND IT'S A TERRIBLE BURDENOT ADMINISTRATIVE STAFF TO DO THAT BECAUSE THE BOOKS CLOSED SO THEY HAD TO GET EVERYTHING GOING VERY QUICKLY TO MAKE THAT DEADLINE. AND YOU KNOW THEY'RE GREAT PEOPLE AND DO IT BUT IT HAS A LESSON THERE THAT THEY CAN ACTUALLY DO THIS IF YOU PUT THE RIGHT MECHANISM IN PLACE. >> WELL, JUST IF I MIGHT INTERJECT, WHEN YOU TALK ABOUT THE OCTOBER COUNCIL, YOU'RE REALLY TALKING ABOUT YOUR SEPTEMBER/OCTOBER COUNCIL BECAUSE THAT'S THE ONLY WAY CAN YOU ACTUALLY DO THAT AND NINDS IS ONE OF SEVERAL INSTITUTES THAT DOES EXACTLY THAT AND THAT'S THE SEPTEMBER COUNCIL AS THE CURRENTS FISCAL YEAR AS OPPOSE TO THE NEXT FISCAL YEAR FOR FUNDING. THAT'S THE--THAT'S THE DISTINCTION BUT THAT SHOULD BE VIEWED AS SEPTEMBER COUNCIL AND SEPTEMBER YOU HAVE TO PAY BY IT'S OVER--YEAH. >> RIGHT. >> BUT THE LESSON IS THAT YOU CAN ACTUALLY DO IT BUT THE GRANTS MANAGING PEOPLE ARE UNDER INCREDIBLE PRESSURE AT THAT TIME PERIOD AND IT'S KIND OF LIKE THE MOST HATEFUL TIME OF YEAR FOR THEM AND THEY ARE ABLE TO DO THIS. AND THERE IS A LOT OF VARIABILITY IN TERMS OF THE OTHER INSTITUTES. THIS IS KIND OF A KINETICS OF WHAT WE COULD SEE ABOUT HOW THE DIFFERENT INSTITUTES PROCESS GRANTS. SO THIS IS A TIME FROM SUMMARY STATEMENT TO THE AWARD IN FY13 AND THESE ARE DIFFERENT ICs AND WHAT YOU CAN SEE IS THAT THERE'S OFTEN TIMES A DELAY AND THEN THERE'S A RAPID UPSHOOT AND THEN THERE'S A LAG HERE. SO THE QUESTION IS TO TRY--SOMETIMES THOSE DELAYS ARE THE FACT THAT SURELY NOT BUDGETING THIS AND HOLDING EVERYTHING AND THEN OKAY, LET'S GO AND 90 DAY GUESS FAST AND YOU HIT THE TRIGGER BUT YOU FUND THE GRANT. SO THE RISE TIME IS NOT THAT DIFFERENT AMONG INSTITUTES BUT IT'S THE DELAY PERIOD WHETHER THEY START AND THEN THERE'S A LAY PERIOD THEY ALL HAVE AND THAT'S HOLDING THINGS OVER UNTIL THE VERY END TO KNOW THAT YOU'RE NOT MAKING OBLIGATIONS THAT YOUR BUDGET WON'T MEET BECAUSE IT CAN'T ACTUALLY FIGURE OUT HOW MUCH YOU WILL SPEND EVERY YEAR. THERE'S SO MANY DIFFERENT THINGS THAT HAPPEN CURDURING THE YEAR THAT--TO ACTUALLY ALLOCATE ALL THE FUNDS AT THE END OF THE YEAR BECAUSE IT'S VERY TRICKY BUSINESS AND THERE ARE DIFFERENT MECHANISMS WE USE. SO AT THE END OF THE YEAR, HIGH PRIORITY PROGRAM GRANTS, WE TEND TO KEEP TOWARDS THE END OF THE YEAR AND USE THOSE IF WE HAVE EXTRA MONEY, IF WE DON'T HAVE EXTRA MONEY, WE DON'T HAVE ANY OF THAT, SO SOME FLEXIBILITY AND MONEY THAT RETURNS FROM ANYTHING LIKE TRANSLATIONAL PROGRAMS, THEY'RE MILESTONE DRIVEN WHEN WE START THE YEAR, WE MIGHT BUDGET, YOU KNOW FIVE MILLION DOLLAR FOR A PROJECT AND THAT PROJECT COULD CLOSE DOWN THE MISS OF THE YEAR SO IT'S A MILESTONE, ALL OF A SUDDEN 2.5 MILLION DOLLARS THAT SHOW BACK UP ON THE SHEET, CLINICAL TRIALS COULD CLOSE DOWN AND YOU MIGHT GET 15 MILLION DOLLARS FOR THAT, SO LOTS OF VARIATION WHEN WE HEDGE OUR BETS A LITTLE BIT FROM PREVIOUS YEARS EXPECTING THAT CERTAIN THINGS WOULD RETURN TO US IN THE BUDGET BUT THAT IS TRULY A GUESS AND WE COULD AT SOME TIME MIKE A MISTAKE AND BE REALLY KIND OF IN TROUBLE AT THE END OF THE YEAR. WE HAD THAT OTHER POSSIBILITY THAT WE ACTUALLY DO HAVE THE ABILITY IN OCTOBER, TO ACTUALLY START PAYING THINGS FROM NEXT YEAR'S MONEY SO SEE THAT AS A BIT OF A BUFFER. SO THIS IS A QUESTION OF WHETHER THE BETTER APPLICATIONS SCORING FASTER AND SO THIS IS THE TOP FIVE% AND THAT'S ALL AWARDS AND THAT'S A BIT OF MOVEMENT SO THAT THE GOOD SCORING APPLICATIONS ARE MOVING OUT FASTER BUT IT'S NOT--IT'S NOT A GIGANTIC DIFFERENCE BUT THERE'S SOME DIFFERENCE SO THE QUESTION IS SOME PUT THEIR PAY LINE AT FIVE%, BEGINNING OF THE YEAR, AND NOT REALLY NOT HAVE A CONSERVATIVE ESTIMATE, WE DON'T ACTUALLY DO THAT, WE TRY TO FIGURE OUT WHAT WE COULD GET AWAY WITH WITH A BIT OF BUFFER AT THE END SO WE'RE COMING OUT WITH A 14% PAY LINE AND WE TEND WHEN WE PUT A PAY LINE OUT AT THIS TIME OF YEAR, WE TRY TO KEEP TAKEN--THEY PAY LINE FOR THE REST OF THE YEAR WE DON'T MOVE IT FROM CONSERVATIVE TO MORE REALISTIC OVER TIME BUT THAT IS A GAMBLE. BUT IT DOES ALLOW US TO GET A TRIGGER AND DECIDE WHAT WE WILL DO AND BANG, WE PAY THE GRANTS AS SOON AS WE CAN. OKAY. THIS IS JUST IN RO-1S OR R21S, AND R21S ARE SMALLER, LESS RISK, SO THEY DO HOUST A BIT FASTER THAN THE RO-1S. SO THIS IS A PROCESS, SO AS I MENTIONED RIGHT AROUND THIS TIME OF YEAR, WE TRY AND FIGURE OUT WHAT IS THE NEXT YEAR'S PAY LINE GOING TO BE AND THAT'S DETERMINED BY EXISTING APPLICATIONS, PUDGE TOTE BUDGET PROJECTIONS, NOW THAT WE'RE UNDER CR, GROUND WITH THIS, WE KNOW WHAT WE HAVE, SO TODAY, WE BASICALLY SAID, OKAY, LET'S GO OUT WITH THE 14 PERCENTILE BECAUSE WE KNOW WHAT WE HAVE NOW, WE TALKED TO THEM A COUPLE WEEKS AGO, HE SAID DON'T DO ANYTHING UNTIL YOU FIND OUT WHAT THEY PASS. >> ONCE YOU GET--THIS IS NOT A CR, WE HAVE A FULL YEAR OF FUNDING. SO YOU CAN MAKE DECISIONS ON THIS POINT. >> RIGHT. >> SO WHAT WE DO THOUGH IS WE START TO MOVE THINGS BEFORE COUNCIL SO ABOUT SIX-SEVEN WEEKS BEFORE COUNCIL WE TRY TO R21S AND Ks THAT WE THINK ARE GOING TO FALL BELOW THE PAY LINE AND WE CONSIDER THEM IN AN EXPEDITED LIST AND THEN WE FUND AND THE GRANTS MANAGEMENT PEOPLE WORK WITH THE PROGRAM DIRECTRS TO WORK WITH THESE GRANTS TO SEE IF THERE'S ANYTHING FISH THAT'S WOULD DELAY US FROM BEING PAID AND THERE ARE THINGS THAT WOULD DELAY BUT IF THERE AREN'T THEN WE KEEP THEM ON THIS EXPEDITED LIST AND WE SEND IT TO COUNCIL BY E-MAIL SO WE HAVE A SUBCOMMITTEE OF COUNCIL THAT GOT THESE GRANTS LAST WEEK AND SO THEY GIVE THEIR APPROVAL, WE WILL START, THE BUDGET PEOPLE WILL START PUTTING THE GRANTS OUT EVEN THOUGH COUNCIL IS NOT TILL THE END OF JANUARY. SO THAT'S ONE WAY IN WHICH WE CAN MOVE THINGS QUICKER BUT IT'S NOT EVERYTHING BECAUSE YOU HAVE TO GO GRANT BY GRANT AND IT JUST TAKES A LOT OF TIME TO GET THROUGH THE HUNDREDS OF GRANTS THAT WE FUND EACH COUNCIL. SO THE COUNCIL SUBCOMMITTEE GETS THESE, IF THERE ARE ANY CONCERNS, THEY'RE HELD AND NOT PAID UNTIL COUNCIL DISCUSSION COMES, AND THE BIG ISSUES ARELET REGULATORY COMPLIANCE AND BUDGETARY ISSUES THAT ARE RESOLVED BEFORE THE AWARD CANS BE MADE BUT SOME GRANTS ARE EASIER TO TO DO THAN OTHERS AND SOME ARE CLEAN AND GRANTS MANAGEMENT PEOPLE CAN PUT THEM OUT QUICKLY. SO WHEN THAT GET THIS LIST, THEY GO RIGHT OUT TO THE GRANTEES TO TRY AND GET JUST IN TIME INFORMATION, TRY AND GET IN TOUCH WITH THE BUSINESS PEOPLE AT THE EN--STRATEGIES TUITIONS TO MAKE SURE THE BUDGETS MARCH AND THEY'RE TRYING TO DO THIS BEFORE THE COUNCIL MEETS ON THESE EXPEDITED GRANT SPECIALIZATION OF SPECIFIC ENDOTHELIAL WE WORK WITH THE INSTITUTION AND THE UNIVERSITY TO MAKE SURE THE PATH IS ISSUED BEFORE THE AWARD AND THEN THEY LOOK UP THE GRANTS AND MOST CASES THIS EXPEDITED CLEAN LIST, MOST OF THE GRANTS ARE READY TO BE AWARDED JUST BEFORE OR JUST AFTER THE COUNCIL MEETING. WHAT SLOWS DOWN THE AWARD ARE THINGS THAT NEED TO BE RESOLVED WITH AN INSTITUTE, PARTICULARLY IF THE LOOKS LIKE THIS IS OVERLAP BETWEEN ONE GRANT AND SOMEBODY HAS ANOTHER GRANT THEY HAVE, WE HAVE TO DEAL WITH THAT, GRANTS THAT ARE TRICK SCHEONE WHICH A MILESTONE BASE AND CLINICAL TRIAL GRANTS, TRANSLATIONAL GRANTS AND MILESTONE BASE AND WE DON'T--THE NOTICE OF GRANT AWARD IS BASICALLY IT'S THE ONLY WAY WE HAVE TO ENFORCE OUR MILESTES AND THE IDEA ON THESE GRANTS IF YOU DON'T--YOU KNOW YOU DON'T SHOW X BY THE Y, THIS GRANT WILL STOP SO YOU CAN'T MAKE THAT UP ONCE THE GRANT AWARD IS OUT. THOSE TERM VS TO BE IN THE GRANT AWARD SO THEY HAVE TO BE--THEY HAVE TO BE DEVELOPED WITH THE PIs BEFORE THE GRANT GOES OUT AND THAT CAN BE A REAM NEGOTIATION AND THAT CAN CERTAINLY SLOW THINGS DOWN. AND UNRESOLVED CONCERNS ABOUT THE HUMAN SUBJECT, AND THE ANIMALS WILL SLOW THINGS DOWN, FORIN GRANTS CAN'T BE EXPEDITED, NOT MANY OF THOSE AND REGISTRATION WITH THE VARIOUS COMPONENTS OF THE PAY PROCESS CANNING TIME CONSUMING. SO GETTING THE DUNS NUMBERS AND GOING THROUGH THE GRANTS PROCESS. THE CLINICAL TRIALS ARE CERTAINLY AND THE TRANSLATIONAL GRANTS ARE CERTAINLY THE HARDEST ONES THE AVERAGE TIME FOR THOSE GRANT AWARDS FOR CLINICAL TRIAL SYSTEM STILL 4.8 MONTHS AND SO WE TRIED TO LOOK AT THIS AND TRIED TO DO A COUPLE OF THINGS, AND ONE IS THAT WE USED THE AWARD CLINICAL TRIALS AND THE PEOPLE SAY, WELL WE'LL GET AN I. N. D. AND THEN THEY CAN'T GET THE MONEY AND YEARS WOULD GO BY AND WE WOULDN'T GIVE THEM THE GRANT AWARD BEFORE THEY HAD THE IND SO THAT WAS A LONG DELAY. I THINKER IN THE PAST THEY DID GIVE THEM THE MONEY AND THAT WAS BAD BECAUSE THE MONEY WAS SPENT AND NOTHING HAPPENED. O NOW WE REQUIRED I& D BEFORE THEY SUBMIT THE GRANT WHICH IS A TOUGH THING TO ASK OF PEOPLE BUT WE FELT WE HAD TO DO IT TO BE GOOD STEWARDS OF IT IS MONEY. THEN WE ALSO HAVE NETWORKING NOW CLINICAL NETWORKS THAT DO THE TRIAL AND IT IS NETWORKS ONCE THE GRANT GETS A GOOD SCORE, EVEN BEFORE IT'S GONE TO COUNCIL THEY DO WORK TO SET UP A TRIAL, WITH THE ASSUMPTION OR WITH THE EXPECTATION THAT THE GRANT HAS A HIGH PROFILE LOOK OF GETTING FUNDED SO A LOT OF WORK CAN BE DONE IN ADVANCE, COUNCIL APPROVES THEY CAN GO AND THEY CAN GET THE E RBs VERY QUICKLY. WE DON'T GIVE THE GRANTS UNTIL THERE'S IRB APPROVAL. SO THAT'S OFTEN THE FIRST STEP BUT WITH THE NETWORKING WITH A CENTRAL IRB, THEY GET DOWN TO A MONTH AND ALL THE IRBs DONE, SO THAT CAN MOVE THINGS MORE QUICKLY. WE MEET WITH THE STUDY TEAMS BEFORE THE AWARD IS GIVEN OUT IF THEY HAVE A HIGH YOU KNOW PROBABILITY OF GETTING FUNDED, YOU START TELLING THE BUSINESS OFFICE TO RESOLVE ISSUES AND GET PEOPLE ON TRACK AND CERTAINLY THAT'S A LOT EASIER IN THE NETWORKS. INDUSTRY TRIALS ARE ACCEPTED. WE DO SOMETHING WITH INDUSTRY CHYLES. IT'S DIFFERENT AS WE--YOU EXCEPT THE XO-ONE ON A LOWERING BASIS SO THEY CAN SUBMIT TRIALS ON A NETWORK. SO TO GET INDUSTRY YOU HAVE TO HAVE IT OVER TIME, THEY'RE TIME DEPENDENT SO THEY CAN SUBMIT THE EXCELLENT ONES THEY HAVE AN SUBCOMMITTEE BY E-MAIL AND THEY HAVE A YES OR NO DECISION THAT THAT MAKES SENSE OR NOT ON A ROLLING BASIS. AND THE IND I TALKED ABOUT. IT WAS--THOSE ARE THE KINDS OF THINGS WE'VE BEEN DOING, WE'RE UNDER STORY AND UNDERNEATH AND TRYING TO MAKE THINGS MORE EFFICIENT. AND THERE WAS A LOT OF ISSUE EVEN TALKING ABOUT COMING INTO PLAY AND OTHER--A LOT OF INSTITUTES HAVE DIFFERENT IMPRESSIONS ON THEM, SO YOU CAN'T GENERALIZE BY INSTITUTES BUT WE HAVE BEEN ABLE TO MOVE THINGS AS QUICKLY AS WE CAN. SO HAPPY TO ANSWER ANY QUESTIONS. >> THANK YOU WALTER. QUESTIONS? COMMENTS? SCOTT? >> CONGRATULATIONS ON A REMARKABLE-- >> NOT ME, THE GRANTS MANAGEMENT PEOPLE. THEY ARE GREAT. >> I MEAN THE GROUP WORKING ON THIS SHOULD GET KUDOS FOR THE ACCOMPLISHMENTS HERE. IF YOU LOOK OVER YEARS, AT THE TIME GONE UP EVEN THOUGH YOU'VE DONE SO WELL? >> I DON'T KNOW THE ANSWER. I COULD LOOK AND TELL YOU, YES. >> NOT SURE. IT'S PRETTY BAD--[LAUGHTER] YEAH. >> NOT GOING TO GO ON. >> IT'S MORE, AGAIN REFLECTING OF DEALING WITH THE INCREASE AND THE APPLICATIONS AND THE REVIEWING PROCESS IF YOU ACTUALLY KEPT PRETTY MUCH THE SAME TIMING, SAME TIME FRAME EVEN IN THE FACE OF LARGER APPLICATIONS? RIGHT? >> I CAN GET BACK, I ASK MY FOLKS ABOUT THAT. >> MAYBE A MORE GENERAL QUESTION, THE INCREASE IN APPLICATIONS THAT UP TO 85,000 SOMETHING, ARE THOSE EVENLY DISTRIBUTED BETWEEN INSTITUTES AND CENTER? NO, STEVE SAYS NO, THERE'S INCREASED BURDEN ON SOME INSTITUTES. >> MOST OF THAT, OF THE 85,000 APPLICATIONS, LET'S SAY MOST OF THEM ARE FOR N. I. A. THERE'S A SMALL PORTION WE DO FOR OTHER AGENCIES, AS I UNDERSTAND IT THAT FIGURE THAT'S BEEN USED OVER THE YEARS IS THAT 75% OF THOSE APPLICATIONS ARE REVIEWED BY CSR. AND THAT REPRESENTS ABOUT 50% OF THE FUNDING THAT GOES OUT FROM THE INSTITUTES. SO 75% IS REVIEWED BY CSR, 25% IS REVIEW BY THE INSTITUTES MAYBE A LITTLE BIT SMALLER IN 25%. THE DOLLAR FIGURES, NOT SURPRISINGLY, ARE 50% OF THOSE DOLLARS COME FROM THE INSTITUTES FOR THOSE--FOR THOSE 25% OF THE GRANTS BECAUSE WHAT WALTER WAS TELLING YOU AND WHAT I WILL TELL YOU, MOST PEOPLE WILL TELL YOU IS THAT IT'S A LARGE GRANT AND MULTICENTER STUDIES TELL YOU, THEY ARE REVIEWED WITNESS THE INSTITUTE REVIEW GROUP RATHER THAN TO CSR. OTHERS MIGHT HAVE DIFFERENT OPINIONS. >> JUST ANOTHER QUESTION. HAS ANYBODY EVER DONE AN EXPERIMENT WHERE YOU HAVE TWO PEER REVIEW GROUPS REVIEW THE SAME GRANT REQUESTS TO SEE IF THERE'S FIDELITY IN THE SYSTEM? >> I KNOW CATHY WANTED TO MENTION IT, IT MIGHT BE AN EXPERIMENT GOING ON THERE, I'VE SEEN IT HAPPEN BY ACCIDENT, IT'S NOT PRETTY, IT WASN'T PRETTY. WE DO HAVE--AS [INDISCERNIBLE] IS GETTING UP, WE LOOKED YEARS AGO WE WERE ACCEPTING PROJECT GRANTS, AND PROGRAM PROJECT GRANTS ARE MADE UP OF PROJECTS THAT ACTUALLY WERE ALLOWED TO BE SUBMITTED AS INDIVIDUAL UNITS, AS INDIVIDUAL RO-ONES AT THE SAME TIME THEY WERE A PART OF A PROGRAM PROJECT AND THE CONFIDENCE BETWEEN THE SCORES AS A PART OF THE PROGRAM PROJECT AND AS THE INDIVIDUAL SCORE THEY WERE CONFIDENT ABOUT 40% OF THE TIME AND THE OTHER 60% OF THE TIME THEY WERE EITHER OFF HIGH OR OFF LOW. THAT WAS NOT A LARGE END BUT IT WAS AN END. >> CAN I MAKE A COMMENT? >> GO AHEAD, GIL. THIS IS THEM ENDOUS INPUT FOR OUR WORKING GROUP, WALTER IT'S--WE'VE HEARD MANY TIMES FROM OUR INSTITUTE DIRECTOR COLLEAGUES THAT THERE'S QUITE A VARIETY OF THE NIH, COMPLICATED ENTERPRISE AND DIFFERENT PRIORITIES AND DIFFERENT PRACTICES AND DIFFERENT HISTORIES. I WOULD THINK FEEDING BACK THIS KIND OF INFORMATION AND DECISION THAT UNDERLIE THE DIFFERENCES IN TIME TO AWARDS OR TIME TO DECISIONS WOULD BE A VALUABLE BEST PRACTICES APPROACH WITHIN THE NIH ITSELF AND I'M CURIOUS HOW MUCH OF THAT GOES ON, IS THERE A BODY WHERE THE GRANTS PEOPLE OR THE DIRECTORS OF VARIOUS INSTITUTES ACTUALLY GO THROUGH THIS KIND OF ANALYSIS AND CONSIDER SOME OF THE FACTORS THAT YOU'VE HIGHLIGHTED FOR EXAMPLE, THE USE OF THE COMMITTEE OF THE COUNCIL FOR A NONINPERSON RERUE AND I'M CURIOUS IF YOU HAVE ANY PEER REVIEW THAT'S DONE OUTSIDE THE MEETING ROOM ALSO? AND A VARIETY OF OTHER PARAMETERS THAT ARE QUITE CRITICAL INCLUDING A SIMPLE MATTER AS WHICH DATE IN SEPTEMBER DO YOU GET FOR THE BUILDING 31 CONFERENCE ROOM BECAUSE IF YOU'RE EARLY IN SEPTEMBER, VERSES LATER IN SEPTEMBER, YOU MIGHT HAVE A BETTER CHANCE OF FINISHING OFF APPROVED GRANTS IN THAT FISCAL YEAR. TAKE THAT ANY PLACE THAT'S USEFUL. >> CAN I RESPOND, MOST OF US DO HAVE A SUBGROUP OF COUNCIL FOR THE SEPTEMBER COUNCIL BECAUSE WE HAVE ALL THE SCORES, ALONG BEFORE COUNCIL. WE HAVE ALL THE SCORES FOR SEPTEMBER COUNCIL, WE HAVE THE SCORES BY THE EARLY PART OF AUGUST, THAT'S--THOSE ARE THE LATEST ONES, WE KNOW WHICH WE'RE GOING TO FUND AND BECAUSE WE DON'T WANT OUR GRANTS MANAGEMENT TO AWAIT UNTIL THE OKAY, WE DO HAVE A SUBCOMMITTEE OF COUNCIL THAT PROVIDES APPROVAL UP TO A CERTAIN POINT AND UP TO A CERTAIN PRIORITY WHICH WE ASK FOR AND THAT'S HOW THE NIMS HAS BEEN FUNCTIONS FOR THE LAST 15 YEARS AT LEAST. BUT BUT THEY SUGGEST THAT THERE ARE SOME WHO ARE CLOSE TO THE NEUROLOGICAL INSTITUTE--NINDS NUMBERS AND OTHERS ARE VERY FAR AWAY. SO WE DON'T KNOW WHO THEY ARE, DOESN'T MATTER EXACTLY EXCEPT THAT IT WOULD BE GOOD TO KNOW THERE'S A PROCESS TO TRY TO HELP THE FOLKS WITH THE VERY LONG-TERMS TO MOVE FORWARD A MORE OPTIMAL PICTURE. >> I CERTAINLY AGREE WITH GILL THAT SOME COMPARISON, THE AWARENESS OF THE NUMBER SYSTEM A GOOD IDEA AND I THINK THAT THIS NUMBER, THAT THEY CLUSTER CLOSELY FOR MAY, BUT SHOW DIFFERENCES FOR THE OTHER TWO OF THESE SHOW THAT PART OF THIS IS DIFFERENCE IN PROCESS. THERE IS A GROUP CALLED THE EPMC MANAGEMENT WHO TALKS OVER ASPECTS OF THIS AND INDEED MOST COUNCILS DO USE SOMETHING LIKE AN EARLY CONCURRENCE PROCESS AND THAT ISN'T TO SAY THAT WE CAN'T LEARN FROM SOME OF THE MANAGERIAL DIFFERENCES AND TRY TO TIGHTEN THIS UP CERTAINLY I HAD A SMALL CENTER IN WHICH A SIZABLE PORTION OF OUR FUNDS ARE INTERVENTIONAL TRIALS AND THOSE POSE AS WALTER INDICATED A COMPLEX SET OF DECISIONS AND PROCESSES THAT NEED TO BE WORKED THROUGH AND MUST BE DONE CAREFULLY AND ANOTHER ONGOING COMPLEXITY IS THE NEED FOR INVESTIGATIONAL NEW DRUG OR DEVICE ISSUES AND USUALLY IT IS BET TORE SOLVE THOSE PREAWARDS. NOT ALWAYS, BUT USUALLY. LOOKING AT NOSE NUMBER SYSTEM WORTH WHILE BUT UNDERSTANDING THE COMPLEXITY OF THOSE NUMBER SYSTEM ALSO IMPORTANT. >> ABSOLUTELY. BUT S&P THERE A FORM FOR DOING THAT. >> SO THIS IS DELA HAND I'M JOINING THE CONVERSATION NOW, I'M JOINING THE EXTRAMURAL RESEARCH AND DR. BRIGS JUST PROVIDED A NICE OVERVIEW OF THERE IS AN INTERNAL WORKING GUP THAT FOCUSES ON MANY OF THE ISSUES WITH REGARD TO THE MANAGEMENT OF THE WHOLE REVIEW GRANT PROCESS, SO FROM APPLICATION TO REVIEW TO POST AWARD MONITORING. AND AS SHE SAID IT'S CALLED THE EPMC GROUP SO WHILE I DON'T BELIEVE AT LEAST IN RECENT HISTORY WE LOOK AT THE SPECIFIC DATA THAT'S HERE, WE DO HAVE A GREAT DEAL OF CONVERSATION WITH REGARD TO VARIOUS PROCEDURES THAT CAN BE USED TO HOPEFULLY STREAMLINE AND FACILITATE THE WORKINGS OF THE INSTITUTE AND THE WHOLE EXPEDITED COUNCIL REVIEW THAT WE'RE TALKING ABOUT WAS AN OUTGROWTH OF WORK THE EPMC HAD DONE MANY YEARS AGO. IT'S BEEN AROUND FOR A WHILE TO HELP PEOPLE FACILITATE THAT AND GET PEOPLE COMFORTABLE WITH THAT APPROACH BECAUSE PRIOR TO THAT IT WASN'T AND SO EVERY CHANGE ESSENTIALLY REQUIRES GOOD CONVERSATION BECAUSE OF DR. BIGGER'S INDICATED TOO, THE INSTITUTES ARE QUITE, QUITE, VARIABLE. SO WHAT MAY WORK FOR ONE INSTITUTE MAY NOT WORK FOR ANOTHER BECAUSE OF THE NATURE OF THE PORTFOLIO. SO NLM HAS A VERY DIFFERENT PORTFOLIO THAN WHAT DR. CATS HAS IN HIS PORTFOLIO, SO DEVELOPING POLICIES THAT CAN HAVE DEPTH OR HARM TO SOMEONE WHO'S PORTFOLIO IS DIFFERENT, IT'S SOMETHING THAT GETS DISCUSSED ESSENTIALLY IN THE FORUM BUT LOOKING AT THESE DATAL BE VERY INTERESTING AND HAVE THAT KIND OF DISCUSSION WILL BE ABSOLUTELY RIGHT ON TARGET. >> THANK YOU. >> ONE QUESTION AND ONE COMMENT AND THE QUESTION GOES BACK TO AT THE JANUARY COUNCIL MEETING, NEUROLOGY INSTITUTE WAS TARGETING THE 12 OR 14% LEVEL AND IT WOULD BE INTERESTING TO UNDERSTAND WHETHER MOST OF THE OTHER ICs DO THAT IN JANUARY OR DO THEY GO DOWN TO THE FIVE%, BECAUSE MAYBE THAT IS VERY IMPACTFUL ON THE PROCESS. THE SECOND THING WHICH IS CLEAR FROM DR. HUDSON'S PRESENTATION PARTICULARLY IN THE CLINICAL FUNDING SETTING IS THAT MAKING THOSE DECISIONS AND GETTING THE IRB APPROVAL AND ESSENTIAL APPROVAL IS INTACTFUL ON THIS PROCESS, SO AGAIN ALL THESE OTHER ANCILLARY THINGS, YOU KNOW HOPEFULLY AFFECT THE AWARDING SO HAVING CENTRAL IRBs AND GETTING THAT GOING FORWARD WILL I THINK HELP ALSO THE BUDGETING PROCESS. >> I MEAN I THINK THE KEY THING IS WHETHER OR NOT YOU FUND FROM YOUR OCTOBER COUNCIL ON PREVIOUSLY YOUR MONEY OR NOT, THAT'S--THAT I THINK IS THE BIG CHANGE. >> SO THAT'S TREMENDOUSLY BI-MODAL, IF YOU LOOK AT AS WE DID AS A CONSEQUENCE OF THIS EXERCISE, WE HAVE BEEN GOING THROUGH, THAT'S SEPTEMBER COUNSELS AND I WILL BI-MODAL SO SOME YOU PAY OUT OF THE CURRENT YEAR AND SOME YOU WAIT UNTIL THE NEXT YEAR AND EVEN IF YOU WAIT FOR EXAMPLE, TILL THE JANUARY COUNCIL WHEN YOU HAVE A FIRM--WHEN YOU HAVE A FIRM PAY LINE, THAT IS EXTENDED FROM TIME OF APPLICATION TO TIME OF FUNDING TO ALMOST A YEAR BECAUSE YOU'RE APPLYING FOR FOR THE SEPTEMBER COUNCIL SO YOU'RE APPLY NOTHING FEBRUARY, YOU'RE PAYING IT IN JANUARY, IT'S 12 OR 11 MONTHS AND THAT'S A CLEAR, REAR ISSUE, THAT ALL OF US DEAL WITH. >> BUT FLEXIBILITY IS VERY IMPORTANT BECAUSE OF THE FACT, MOST OF YOU ARE AWARE WE CAN HAVE FLUCTUATES IN OUR NONCOMPETING CONTINUATION COMMITMENTS AND ONE OF THE WAYS TO SOMEWHAT BUFFER THAT AND KEEP FROM HAVING YEARS IN WHICH PAY LINES MIGHT FALL EVEN MORE DRASTICALLY THAN THEY ARE NOW IS BY HAVING FUNDING FLEXIBILITY AT THE END OF THE YEAR. >> BUT TO THAT COMMENT AND I RESPECT WHAT HAPPENED WITH ENERGY WITH REGARDTO THE CHANGE IN THE FLEXIBILITY THERE IS EXCEPT FOR THE SEQUESTRATION WHICH WHICH IS REALLY AN ABNORMAL CIRCUMSTANCES OF HISTORY IN THE FUNDING PROCESS BUT NIH OVERALL BUDGET DOESN'T GET CUT, IT'S FLAT LINED AND IT'S REAL DOLLARS GOES DOWN SO WHY CAN'T YOU USE THE ESTIMATES FOR FLAT LINE IN EVERY CASE, I THINK THAT WILL GIVE YOU COMFORT THERE, YOUR CONCERNS ABOUT CUTTING MAY BE A LITTLE BIT OVERBLOWN. >> IN LARGE INSTITUTES THAT'S PROBABLY POSSIBLE, IN THE SMALLER PLACES CAN YOU HAVE BIG BUDGET FLUCTUATIONS, FOR EXAMPLE, THE LARGE TRIALS ENDING OR STARTING. I DO THINK THERE'S A LARGER IN THE INSTITUTES HERE AND THE FLEXIBILITY IS ESSENTIAL AND ALTHOUGH NONE OF US RECOVERED YES FROM NOT ONLY SEQUESTRATION BUT OUR BUDGETS ARE BELOW THEY WERE AS WELL AND WE ULTIMATELY KNOW THERE'S KEEPING BASE WITH THE INFLATION SO THAT AS THE ACTUAL DOLLARS MAY STAY RELATIVELY FLAT, WE CAN BUY LESS AND LESS WITH THAT AND AND ANYTHING THAT'S COMPLISHED THAT'S INTENDED BUT IT'S A DIFFICULT SITUATION BUT I THINK THAT SEVEN WORKING VERY HARD IN THEIR SEPTEMBER OCTOBER COUNCIL. I THINK THE POINT THAT SOMEONE MADE THAT ABOUT JUST WHEN YOU HAPPEN TO HAVE IT ASSIGNED. IF YOU DO IT SEPTEMBER SECOND AND THIRD, YOU'RE MUCH BETTER SHAPE TO GET THE FUNDING OUT THE DOOR FOR SEPTEMBER 20th AND 21st. AND I THINK WE ALL DO THAT STEVE, I DON'T KNOW IF THERE'S ANY GROUP THAT DOESN'T DO THAT NOW AND WE ALL HAVE ISSUES WITH NOT ONLY INTERVENTIONAL TRIALS BUT OBSERVATIONAL STUDIES WHERE I REALLY LIKE YOUR IDEA AND IT MAY BE SOMETHING WE WANT TO THINK ABOUT WITH OBSERVATIONAL STUDIES AS WELL AS LIKE REQUIRING IRB, AT LEAST TENTATIVE IRB APPROVAL AND STUFF SO WE CAN MOVE THINGS MORE RAPIDLY THERE. BECAUSE I THOUGHT [INDISCERNIBLE]. THE INITIATION AND COMPLETION, THE TWO LAG PERIODS BECAUSE SOME OF THAT IN THAT NICE--THE VERY NICE GRAPHIC IF YOU MADE IT LINEAR THEN YOU COULD HAVE A NICE STRAIGHT LINE TO LOOK AT THE DIFFERENT SLOPE BUT THE POINT IS YOU HAVE BOTH AT THE BEGINNING AND AT THE END IS WHERE THINGS FALL OFF AND IN THE MILL THINGS MOVE SIMILARLY. BUT I THINK WE ALL WOULD LOVE WHICH ONE IS OUR LINE. >> I THINK THE--WE WOULD LIKE THAT. >> I THINK THE TIGHTER BUDGETS AND OTHERS ARE ONE WE HAVEN'T TALKED ABOUT IS A NUMBER OF ICs OF COURSE ARE MOVING FROM ARE INHERENT OF THE PAY LINES BECAUSE IT BECOMES INTELLECTUALLY MORE AND MORE TENUOUS TO ARGUE THAT OH SOMETHING JUST ABOVE THE PAY LINE THAT IS WAY DOWN DOWN WAS WORTH FUNDING SO BECAUSE OF THAT NUMBER OF ICs IS FUNDING AND AS YOU DO THAT, THATADS TIME TO THE PROCESS AND NOT JUST DO IT AUTOMATICALLY, SUCH PERCENT WE SHOULD DO THIS AND FIGURE UP, YOU WANT TO ALL THAT KIND OF THING, I THINK ALSO IS A FUNDAMENTAL DRIVER BUT IT'S A COMPLEXITY. >> IT'S PRETTY STRICT PAY LINE INSTITUTE SO IT'S--IT IS A MATHEMATICAL FORMULA FOR US SO THAT'S EASE FOR US. >> CERTAINLY CONCUR SENSE SOMETHING THAT MOST OF US INSTITUTE AND THAT,A LOWS WITHIN A CERTAIN LIMIT KNOWN FUNDING AND A WAY TO GET THOSE OUT EARLIER TO GILL'S QUESTION ABOUT, YOU KNOW WHAT ABOUT DOING THESE IN SEPTEMBER AND ACTUALLY SEPTEMBER/OCTOBER COUNCIL BECAUSE MANY OF THESE MEETINGS ARE THREE YEARS IN ADVANCE ALREADY SET UP AND SO THESE ARE ALREADY IN ADVANCE SO WE END UP BEING LUCKY TO GET THIS AND THAT'S A SMALL FACTOR BUT BELIEVE ME IT'S-- >> I THINK--GO AHEAD MARTHA. >> I CONCUR WITH EVERYTHING SAID HERE AND ONE THING THATADS TO THE COMPLEXITY, SOMEWHAT DEFICIENCYS ARE RELATED TO NEW INVESTIGATORS THAT ARE COME NOTHING AND THE YOUNG INVESTIGATORS SO THAT HAS ANOTHER COMPLEXITY, SO THERE'S A LOT OF DIFFERENT THINGS THAT REQUIRE IT. >> THIS DISCUSSION IS IN SOME SENSE THE MICROCOSM OF WHAT THE WORKING GROUP AS BEEN GOING THROUGH AND THE IDEA IN SOME WAYS THE CHALLENGE, WHEN ONE SAYS DOESN'T FIT ALL, IF IT'S CLEAR IT IS A REAL CHALLENGE AS A WORKING GROUP TO COME WITH SUGGESTION WHEN IS ONE SAYS CLEARLY DOES NOT FIT ALL SO THAT SAID WE WERE ALL IMPRESS WIDE WALTERS DATA. H'S GOT--THAT EN--STRATEGIESITUTE HAS IMPRESSIVE NUMBERS AND THERE ARERAPHYS FOR THOSE AND WHY THOSE NUMBERS ARE LOW TO BE DISCUSSED MORE WIDELY WITHIN THE NIH AND WE ARE GOING TO LOOK MORE INTO IT BUT THE DATA WAS IMPRESSIVE AND I WANT TO THANK YOU FOR THAT. WE ARE JUST ABOUT ON SCHEDULE. I DON'T KNOW IF THERE ARE COMMENTS BEFORE WE RETURN TO THE DISCUSSION. AND PANELIST VS BEEN GIVEN INSTRUCTIONS I DON'T KNOW I WILL KEEP TIME BUT YOU'VE BEEN GIVEN INSTRUCTIONTIME BUT THIS PANEL IS THE TITLE OF IT IS APPLICANT PERSPECTIVES ON OPTIONS TO STREAMLINE NIH'S GRANT REVIEW AWARD AND MANAGEMENT PROCESS. WE'RE THANKFUL YOU COME TO TALK TO US TODAY. SOME OF YOU SHOULD GIVE AN INTRO AS PART OF YOUR FIVE MINUTES AND MOVE TO DAVID, ARE QUELL AND ALL OF THOSE IN THAT DIRECTION. >> INTRO IN TERMS OF BIOOR IN TERMS OF WHERE YOU ARE AND WHAT YOU DID IS GOOD. >> SO. >> SO I'M AN INVESTIGATOR AT UC DAVE AND I GUESS I'VE BEEN THERE 11 YEARS AND I LOOK BACK AT HISTORY AND I THINK I SUBMITTED 10 RO-1 PROPOSALS IN THESE 11 YEARS I AM GRATEFUL FOR THE FUNDING I RECEIVED IN 2009 WHICH ALLOWED ME TO BE SUCCESSFUL FOR THE PROMOTION PROCESS SO I HAVE TENURE NOW AT UC DAVIS AND THAT HAS BEEN AN AMAZING SOURCE OF FUNDING FOR MY RESEARCH PROGRAM. INTERESTINGLY I'VE BEEN MORE SUCCESSFUL AT NSF WHICH IS INTERESTING BECAUSE I COME FROM A SCHOOL OF MEDICINE WHICH TRADITIONALLY NSF DOES NOT FAVOR AS MANY MEDICINE, BUT I FEEL THAT AT LEAST IN THEIR GRANT REVIEW PROCESS THE PACKS AND WHAT I BRING TO THE TABLE IS AS AN INDIVIDUAL INVESTIGATOR IS WHAT HAS BEEN AND MA PART OF THE INNOVATIVE HAS BEEN MORE SUCCESSFUL SO THAT'S INTERESTED PROVIDING MY MY COMMENDS ON WHAT'S BEEN DISCUSSED TODAY. >> HELLO I'M VICE PRESIDENT OF RESEARCH FOR THE UNIVERSITY, WIDE RANGE OF APPLICANT AS A REVIEWER AND DEPARTMENT CHAIR FOR 10 YOURS TRYING TO HELP MENTOR FACULTY TO DEVELOP THE RESEARCH CAREERS AND NOW AS VICE PRESIDENT FOR RESEARCH, DEALING WITH THE MACHINERY OF RESEARCH AND AND THE OPPORTUNITIES AND LOOKING AT IT FROM A WIDER PLAYING FIELD THAN I HAD BEFORE WHICH IS DOESN'T TO FUNDING AGENCIES AND CULTURES OF RESEARCH, IN MY 300 SECONDS I WAS GOING TO MAKE TWO POINT FIST I COULD--THEY FELT LIKE I DID WANT TO MAKE THAT STRUCK A CORD WITH ME AT LEAST AS BEING QUITE IMPORTANT AND THE FIRST IS IN THE RESEARCH MACHINERY AND WE RECOGNIZE IN TERMS OF THE BIRDEN THAT IN HIND SET TURNS US [INDISCERNIBLE] AND SOMETHING THAT SHIFTED FROM EVERY APPLICANT DOING IT ONLY BEING DONE FOR THE SUCCESSFUL APPLICATION CANTS HAVE YOU REDUCED THE BURDEN BY ABOUT 90%. THIS IS NOT A MARGINAL CHANGE. WHETHER IT'S A PHOTOGRAPH OR FORM IT MAKES A HUGE DIFFERENCE AND FROM THE INVESTIGATOR'S POINT OF VIEW IT'S MOTIVATING AND SCRAMBLE AND DO THE WORK THAN IT IS WHEN YOU REALIZE REALIZE THAT THE SCREENING IS GOING TO BE SO STRINGENT AS IT HAS TO BE YOU'LL KNOCK OFF THE BURDEN FROM THIS AND THE IDEA OF A PRESCREENING AND THERE ARE INSTITUTES THAT DO THAT MORE AND BESIDES THE EFFICIENT OF NOT WRITING PROPOSALS THAT WON'T--THAT HAVE NO HOPE, I ALWAYS THINK WHEN I'M ADVISING COLLEAGUES WHEN THEY CHOOSELET TITLE AND TOPIC IN MANY CASES THEIR FATE IS DOOMED, THEY JUST DON'T KNOW IT YET. SO EVERYTHING THEY DO FROM THAT MOMENT FORWARD IS WASTED EFFORT AND IF WE COULD SEE AHEAD IT WOULD BE WONDERFUL BUT REALLY THINKING ALSO IN TERMS OF THE INNOVATION. WE ALWAYS WANT PEOPLE TO SORT OF TAKE THEIR CRAZY OUT OF THE BOX AND GIVE IT A SHOT AND THEY AREN'T CRAZE SCHENOT GOING TO GO ANYWHERE BUT IF THE CLERK HOLDS WERE DIFFERENT PER PUTTING OUT THE CRAZY IDEA AND GETTING A PRESCREENING IT MAKES YOU MUCH BRAVER WHEN YOU'RE CRAZY IDEA WILL TAKE THREE MONTHS OF INTENSIVE EFFORT AND A FULLY DEVELOPED PROPOSAL AND YOU RECOGNIZE THAT IT'S VERY SORT OF CONCEPT, MAYBE DOOMED IT'S INHIBITING AND YOU CAN'T SAY LET'S TAKE 10 SHOTS AND SEE DID SOMETHING INTERESTING COMING UP AND RECOGNIZING TIME AND EFFICIENT, SOME MECHANISM THAT LETS YOU PUT IT OUT THERE AND GET THAT INITIAL EXPERT REACTION, LIKE, OH THAT'S EXCITING, I WONDER WHAT THEY COULD DO WITH THAT, NO PROMISES, NO GUARANTEES BUT HAVING THAT THRESHOLD, THERE ARE OTHER INSTITUTES THAT HAVE VARYING FORMS OF PREPOETIC POSALS AND AGAIN, EVERYTHING HAS A DOWN SIDE THERE, 'S ALWAYS UNEXPECTED YOU KNOW CONSEQUENCES AND ENCOURAGING THE KIND OF PRAYLY TO PUT IDEAS OUT THERE WOULD BE ENHANCE BIDE REDUCING THE BURDEN AND THEY'RE UNRETHAT'S WHAT I PITCH. >> I'M RAQUEL GUR, I AM WITH THE PSYCHIATRY, NEUROLOGY AND RADIOLOGY, UNIVERSITY OF PENNSYLVANIA, I WILL 25 YOU MY PERSPECTIVE OF MEMBER OF STUDY SECTIONS, MULTIPLE CAREER AND USING NIMH COUNCIL AND NINDS IS DOING, IT'S EFFICIENT PROCESS AND IS IT'S WHAT DAVID WAS SUGGESTING PRESCREENING AND NOTICE FOR COUNCIL PREV PERIOD OF TIME FOUR TO SIX WEEKS OF MAX OF QUICKLY GOING THROUGH SMALL GROUPS, SUBGROUP SCREENING THOSE AND IT WASTES TIME DURING THE MEETING, THIS CAN BE DONE IN A VIRTUAL MEETING SO SOME ORIENTATION, CAREFUL ORIENTATION OF THE STUDY SECTION MEMBERS BUT IT CAN BE DONE QUITE RAPIDLY AND THE GRANT SUBSECTION ESO WHAT COMES UP TO THE FULL STUDY SECTION, SOME OF THIS THE FOR THE CUTTING EDGE WOULD YOU PUT THEM AT THE TOP AND THEY CAN GET BETTER FOR DISCUSSION I WAS HESITATING BETWEEN A VIRTUAL MEETING THROUGHOUT THE THREE SESSIONS OR TWO SESSIONS OR FACE-TO-FACE MEETING WITH THE ROTATE NOW IN THE STUDY SECTION AND THEN WE ROUGH ATOM TAET BETWEEN ONE MEETING IN THE WEST COAST WITH THE EAST COAST AND WEST COAST, THE GROUPS ARE READY AND IT'S--IT'S A BURDEN, IT'S TRUTHFUL BUT IT'S A BURDEN AND I'M NOT SURE THAT THE VIRTUAL MEETING WE DO COLLABORATION WON'T WORK. ONE POINT, A LITTLE BIT PEUSZ ME OFF, IF PEOPLE DON'T WANT TO REVIEW, I MEAN WE NEED--YOU CAN'T GET PUBLIC MONEY WITHOUT COMMITTING YOURSELF AND IT'S FOR JOURNALS OR PROFESSIONAL SOCIETIES AND JOURNALS AND LET'S MAKE IT KNOWN IN THE SCIENTIFIC MEETING OR REVIEWERS AND DEVELOP A TRACKING SYSTEM FOR REVIEWERS TO BE INCLUDED AS PART OF THE OF THE SKETCH AND THE SKETCH IS UER GOING REVISION AND THE SCIENTIFIC MERIT OF COURSE, SCIENTIFIC MERIT IS NUMBER ONE PRIORITY. BUT ARE YOU USING INDEX AND WE USE IT FOR PROMOTION WITH JUSTICERS ARE YOU A MEMBER OF THE STUDY SECTION, YOU'RE KNOWLEDGEABLE, OR EVEN FEWER THAT CAN BE PUT, WHY NOT PUT IT ON THE BIAS SKETCH SO THAT AND THE POINT IS PUBLISHED INVESTIGATORS AND IT'S [INDISCERNIBLE] WHERE YOU ARE ABLE TO ASK TO ASK FOR ADDITIONAL FUNDS FOR EDUCATION, FOR ESTABLISH CENTERED, FOR P50 MECHANISM PERHAPS SMALLER AMOUNT OF MONEY EXTENDED TO JOURNAL PEOPLE SO THEY COLLECT PILOT DATA AND MOVE QUICKLY TO A K OR EVEN TO AN RO-1 AND SKIP THE K DEPENDING ON THE LEVEL. >> I'M THE CARDIOLOGIST THE CENTER OF THE NONINVASIVE HEAD, I ALSO WEAR A SECOND HAT, AMOUNT OF EXPERIENCE A CARDIOVASCULAR EPIDEMIOLOGIST AND WORK WITH POPULATION BASED COHORTS THAT ARE NHLBI FUNDED. THEY'RE AFRICAN AMERICAN CENTERED STUDY AND THE RISK AND COMMUNITY STUDY AND THE GENOA STUDY AND I MAINLY CONCENTRATE ON THAT CARDIAC REMODELING AND CARDIOVASCULAR OUTCOMES AND DO GENETICS OF CARDIOVASCULAR DISEASE AND MORPHLE BY O MARKERS LOOKING AT PREDICTABLE MODELS INCORPORATING THOSE BIOMARKERS INTO THE MODEL AND THROUGH NLBI, I RECEIVED THE KGRANT, AN RO-1, THE RO-1 WAS TO LOOK AT TO ESTABLISH A VASCULAR [INDISCERNIBLE] LABORATORY AT THE JOCK SON [INDISCERNIBLE] STUDY AND WE ARE BRINGING IN 3800 INDIVIDUALS TO GET IT PHENOTYPES WELL SO WE CAN DO CARDIOVASCULAR OUTCOME STUDIES WITH THE ABILITY OF THOSE GENETICS OF IT AS WELL IN 2011 AND I DID RECEIVE THE PNTIAL EARLY CAREER AWARD FOR SCIENTIST AND ENGINEERS BASED ON THAT VASCULAR AND ENDOTHELIAL FUNCTION AND IT'S STILL ONGOING RIGHT NOW. SO I GUESS IN MY VIEW, THE FIRST TIME I RECEIVED AN RO-1 AND EARLY ON, AT THE EARLY STAGE INVESTIGATOR IT WAS TO GO FROM THE KGRANT UNDERSTAND THE LEAP IS TO GO FROM THE FIRST RO-1 TO THE SECOND RO-1 SO MY BIG PURE S&P FOR THE IDEA WHICH I'M SURE CAN YOU WORK WITH TO LOOK AT EXTENDING YEARS FROM FIVE TO SEVEN. I THINK THEY WILL BE BENEFICIAL BECAUSE YOU'RE THINKING ABOUT THIS EARLY STAGE INVESTIGATOR WHO MAY AT SOME POINT HAVE A GAP IN FUNDING AND LOSE STAFFING, LOSE SPACE AND THEY NEED TO BE ABLE TO CONCENTRATE AND CREATE THE NETWORK TO APPLY AND BE COMPETITIVE FOR THE SECOND RO-1. SO MAYBE THOSE TWO EXTRA YEARS AND WE CONSIDER THOSE THE MOST PROMISING MIGHT BE A BENEFIT IN ORDER TO KEEP THEM IN THE CIRCLE IN THE CYCLE AND NOT LOSE OUT EACH THOUGH THEY CONSIDER PROMISING BECAUSE OF THE PAY LINES VERY LOW AND IT'S VERY COMPETITIVE AND THEY DIDN'T QUITE HAVE THE TIME TO GET IT ALTOGETHER SO I'M THINKING SO THAT CAN HAVE A CHANCE TO BE COMPETITIVE ON THE SECOND RO-1. SO THAT WAS A PRETTY GOOD IDEA. THE PREAPPLICATION, I THINK IS ALSO A GOOD IDEA. AND I AM INVOLVED WITH THE AHA CARDIOVASCULAR GENOME, FETAL COMPARTMENT NOPE STUDY AND I THINK IT'S A COLLABORATION BETWEEN NIH AND AHA, AND THROUGH THAT MECHANISM WE APPLY AND WE GET PREAPPLICATION EVALUATED AND IF IT'S NOT QUITE UP TO PAR, THEN YOU SORT OF GIVE THEM A PLIGHT, NICE BUT YOU MIGHT WANT TO WORK ON IT BETTER BUT WE GOT A MORE COMPETITIVE STUDIES AND WE DON'T WANT YOU TO TRY TO PUT TOO MUCH TIME AND EFFORT INTO THIS PROJECT THAT WE DON'T THINK IT'LL BE VERY SUCCESSFUL THAT'S VERY HELPFUL TO THE INVESTIGATOR AND WE CAN DEVELOP THAT PROG EXPECT DEVELOP NEW PROJECTS AND DO MORE TO DEVELOP THOSE PROJECTS IN ORDER TO MAKE THEM MORE COMPETITIVE AND SO, I THINK THE EFFICIENCY AND TIME ASPECT FOR INVESTIGATORS AND ENHANCED WITH THAT, THAT WITH THAT PROPOSED CHANGE. >> OKAY, THANK YOU ALL FOR BOTH COMING AND MAKING THOSE OPENING COMMENTS AND I'M SURE THERE ARE GOING TO BE COMMENTS FROM AROUND THE TABLE. YOU MAY BE SPECIFIC QUESTIONS TO YOU OR JUST COMMENTS, A DISCUSSION BASED ON THE ISSUES YOU RAISE, BECAUSE GET IT STARTED BY SIMPLY SAYING TO RAQUELL THAT YOUR COMMENTREVIEWERS IS ONE THAT WE'VE SPENT A FAIR AMOUNT OF TIME PUSSING AROUND WITH AND TRYING TO LEARN FROM OTHER PLACES FOR EXAMPLE AND WITH THIS REVIEWING PROPOSALS THAT ARE CNG WITH YOURS AND YOU HAVE HELP WITH GAME THEORY TYPE SPECIALIZATION OF SPECIFIC ENDOTHELIAL THAT THAT WOULD SOMEHOW WORK IN A PRODUCTIVE WAY AND BUT ALSO I MADE LIGHT IN A SENSE WITH MY BANANA COMMENTS EARLIER THAT WE SHOULD TREAT REVIEWERS A LITTLE BIT BETTER BUT IF WE MAKE THE ASSUMPTION NOW THAT AT LEAST THE NUMBER OF APPLICATIONS COME NOTHING WILL NOT GO DOWN THEN WE NEED MORE REVIEWERS AND HOW WE CONDUCT THOSE REVIEWS AND HOW WE GET THOSE REVIEWERS HOW WE CONVINCE PEOPLE AND SERVE AND DO IT A WHILE AGO AND WHAT WE DISCUSSED IS IF YOU HAVE NIH SUPPORT, YOU WILL BE REQUIRED TO SERVE ON A STUDY SECTION. >> IF ASKED. >> IF ASKED. [LAUGHTER] >> AND MY POINT TO GET THAT START SIDE TO SAY THAT'S AN IMPORTANT AND SENSITIVE ISSUE THAT THE WORKING GROUP DISCUSSED AT SOME LENGTH. I HOPE. >> NANCY? >> JUST THINK BEING PREREVIEW OF APPLICATIONS AND WANTING TO INVOLVE MORE REVIEWERS, ONE POSSIBILITY MIGHT BE TO HAVE A DIFFERENT--DIFFERENT GROUP OF REVIEWERS PREREVIEW AND DO IT BY MAIL SO THAT YOU DON'T HAVE TO HAVE THE MEETINGS AND THAT MIGHT BE A WAY TO ENGAGE THE MORE PEOPLE SENIOR PEOPLE AND CURRENTLY REVIEW AND FURTHER BURDEN THOSE WHO ARE INVOLVED IN THE STUDY SECTION. >> SO I WOULD LIKE TO THANK EVERYBODY FOR PRESENTING, AND CONGRATULATIONS ON THE PK-AWARD AND THAT'S A GREAT HONOR AND IT WILL BE STAY WITH YOU FOR A LONG TIME. THE OTHER TWO COMMENTS I HAD, WAS THAT FIRST THE NIH HAS BEEN WORKING IN THE LAST LAST SIX TO EIGHT MONTHS ON THE WHOLE ISSUE OF SUSTAINABILITY AND STABILITY AND WE CAN HAVE A REPORT ON THIS AS THE VARIOUS MEETING AND THESE ARE DIFFERENT THINGS TO TRY TO ADDRESS THAT PARTICULAR QUESTION. >> WE AT THE MUSK LOW AND SKELETAL AND SKIN DISEASES TALK ABOUT WHAT THEY WERE TALKING ABOUT AT A LATER STAGE AND THAT'S 11 RENEWS AT RO-1, ONE WILL BE ELIGIBLE FOR A SUPPLEMENT TO TAKE YOUR RESEARCH PROJECT INTO A PROGRAM AND THAT WILL BE--THAT WILL--THAT WILL ENABLE THE--REALLY THE BROADENING OF YOUR PROJECT TO PROGRAM TYPE OF THING SO THAT IT WOULD BE INVESTIGATOR--INVESTIGATOR DETERMINED AND THAT WILL JUST GO TO OUR COUNCIL SO THAT WILL NOT GO THROUGH, THAT WILL BE A SUPPLEMENT, A RELATIVELY EASY AWARD THAT WILL BE--THAT WILL BE BASED ON AND YOUR OTHER PROGRAM AND FINALLY WITH REGARD TO PREAPPLICATION, WE HAD DISCUSSION AT THIS AT OUR LAST MEETING, IT SEEMS LIKE YESTERDAY, WAS IT YESTERDAY OR FRIDAY OR-- >> THEY DID HAVE A NICE WEEKEND THOUGH. [LAUGHTER] THE PREAPPLICATION PROCESS IS ONE THAT IF ONE THINKS ABOUT THE TIME FROM APPLICATION TO AWARD, IF YOU DON'T INCLUDE THE TIME FROM PREAPPLICATION TO ALLOWING THE APPLICATION, THAT CERTAINLY WOULD NOT PROLONG THE TIMING. THE QUESTION IS THE LOCUST OF THE PREAPPLICATION, IS THE LOCUST OF THE PREAPPLICATION, ARE WE ADDING BURDEN TO THE REVIEW PROCESS, NUMBER ONE. NUMBER TWO, SHOULD THAT PREAPPLICATION BE SOMETHING MUCH MORE FOCUSED IN EITHER THE ACADEMIC SET TAG HAPPENS IN CERTAIN UNIVERSITIES AND NOT OTHERS SORE SHOULD IT BE FOCUSED AS HAPPENS IN SOME OF THE SPECIALTIES THAT WE DEAL WITH, PARTICULARLY IN ORTHOPEDIC AND SOMEWHAT RHEUMATOLOGY WHERE THE COMMUNITY IS DOING THE REVIEWING TO SEE WHETHER THIS WILL FLY OR NOT. I PERSONALLY HAD SAID ON THE MEETING ON FRIDAY THAT I DON'T THINK THE PREAPPLICATION SHOULD BE BASED ON WHETHER THE PROGRAM DIRECTOR THINKS IT'S A GOOD IDEA TO COME FORTH OR NOT. IF YOU CAN GET THE REVIEW GROUP TO DO IT WITHOUT OVERBURDENING THEM, THAT'S FINE. BUT EVERYONE NEEDS SOME--SOME FAIR DISCUSSION AND I'M NOT SURE THAT THE NIH EVEN IF SOMEONE SAYS, WE DON'T WANT YOUR APPLICATION, CANNOT ANYWAY SUBMIT THAT APPLICATION, IS THAT NOT CORRECT? SO WHAT THIS PREAPPLICATION WOULD DO, NOT SO CLEAR, WE AT ONE TIME TALKED ABOUT THE REVIEW GROUPS BEING ABLE TO TELL SOMEONE WHEN WE HAD AN A ONE AND AN A-TWO APPLICATION PROCESS, WE HAD A CATEGORY WHERE DO NOT RETURN CATEGORY RATHER THAN ANYBODY WASTING THEIR TIME AND THAT WAS NOT SOMEHOW EMBRACED, THERE WERE SOME OF US WHO THOUGHT THAT WAS A GOOD IDEA. WE HAVE A SHOT BUT REALLY IF IT'S--IF IT DOESN'T HAVE AN INNOVATION AND DOESN'T HAVE A GOOD PREMISE AND IT'S NOT BASED ON REALLY ANYTHING, THEN WHY ENCOURAGE PEOPLE TO COME BACK. THAT WAS TURNED DOWN SOME YEARS AGO. SCOTT AND THENINANCE SCHEIF IF IT'S NOTES INTERCEPTION, I WOULD LIKE TO TURN BACK TO THE PANEL BECAUSE YOU MOSTLY TALKED ABOUT YOUR BIOAND YOU HAD SOME OTHER THOUGHTS THAT SO THE DIFFERENCES IN OPINION IN THE WHO PROCESS AND BURDENS AND CHALLENGES THAT MAY PREVAIL WITH REGARD TO SPEED AND WE COULD IMPLEMENT THIS AND AND INN CREASE WITHOUT BURDENING THE SYSTEM BUT IN THAT REGARD, AND AT THE QUESTION OF DR. SAVITZ, WHICH IS ON HIS PREAPPLICATION PROCESS, IF YOU WENT THROUGH THIS PROCESS AND THE RESPONSE BACK WAS THAT THE GROUP, WHATEVER GROUP DECIDES THIS FINDS IT'S FAVORABLE, WHAT WOULD BE THE REALISTIC TIME FRAME FROM ONCE YOU GOT THAT FEET BACK, NUMBER ONE, GOING FORWARD, TO ACTUALLY GET THE FULL SUBMISSION OF THE GRANT BECAUSE AGAIN WHAT IS THE LEAST AMOUNT OF TIME YOU HAVE TO GET ON TO THE SYSTEM AND YOU HAVE OTHER PROPOSALS THAT YOU MAY BE ABLE TO ADDRESS THIS. NUMBER ONE. THE SECOND THING WHICH WAS NOT BROUGHT UP TODAY BUT IT'S BEEN BROUGHT UP IN PREVIOUS SESSION SYSTEM THE CONCERN ABOUT BIAS IN THE SYSTEM. AND PARTICULARLY ON THE PREAPPLICATION PROCESS, WHETHER THIS HAS BEEN THE ACTUALLY PREAPPLICATION DEIDENTIFIED, IN OTHER WORDS PEOPLE ARE PUTTING OUT THREE OR FOUR OR FIVE PAGE PROPOSALS WITHOUT ASCERTAINING WHERE THE SOURCE OF THAT IS, TO GET AGAIN A BETTER INNOVATIVE GRANT AND ELEMENT OF BIAS IN THE SYSTEM, SO APPRECIATE THOSE. >> JUST RESPOND BRIEFLY, I KNOW THE TIME IS LIMITED, ONE OF MY JOBS AS VICE PRESIDENT FOR RESEARCH IS LIMITED SUBCOMMISSIONS OF COURSE SO WE HAVE TO DO THIS QUICK SCREENING WITHIN THE UNIVERSITY TO MAKE A DECISION. MY SENSE IS THAT THERE IS AND IT'S--RAQUEL WAS SAYING, BEYOND A QUICK LOOK BY SEVERAL INFORMED PEOPLE, WE GET A FEW BULLET POINTS, I THINK AS YOU GET MORE, IF YOU WILL OBSESSIVE AFTER THAT, DIMINISHING RETURN SETS IN QUICKLY THERE'S A PRETTY QUICK TAKE IF THERE'S UNANIMOUS INTHAOUSIASM OR UNANIMOUS NEGATIVES AND THAT HAPPENS MORE OFTEN THAN YOU MIGHT THINK IN THIS QUICK SORT OF SCREENING, I THINK YOU CAN STREAMLINE THAT PART. I THINK THE QUESTION OF HOW LONG TO DEVELOP A FULL PROPOSAL AFTER THAT THIS IS THE PSYCHOLOGY ON THE TRENCHS AND IF YOU GOT PRESCREENED AND SOME DEGREE OF ENCOURAGEMENT, NOW WE LOOK--OKAY, WHAT ARE THE ODDS OF THE PREPROPOSAL, THE CONDITION OF GOING TO THE NEXT STEP, IF WE'RE IN A RANGE NOW THAT IS MOTIVATING PEOPLE WILL DO AMAZING THINGS, YOU KNOW YOU TELL ME IN A MONTH A FULL PROPOSAL AND IT'LL BE GOOD AND IT'LL BE DONE IN A MONTH, AND I KNOW THAT'S A BIT EXTREME BUT AS YOU MANIPULATE THAT AND MANEUVER THAT IT'S QUICK AND EFFICIENT IN EARLY STAGE THAT. IS ESSENTIAL. YOU DON'T WANT TO GO THROUGH DOUBLE CYCLES BUT THERE'S SO MUCH BEN FROM JUST A DESCENT OR QUICK EARLY STAGE, I DON'T THINK IT WOULD HAVE TO ADD OVER ALL TIME. I CAN'T REMEMBER THE OTHER PART OF YOUR QUESTION? THE OTHER QUESTION IS WITH DEIDIDN'TIFYING PROPOSALS AS A WHY--DEIDENTIFYING PROPOSALs AS A WAY OF BIAS WITH THE WHOLE SYSTEM. >> MY EXPERIENCE IS THAT WITH A UNIVERSITY, EVERYBODY KNOWS EVERYTHING AND IT'S IMPOSSIBLE TO DO IT THAT WAY BUT I THINK AGAIN, I THINK MOST PEOPLE AT LEAST MAKE A GOOD FAITH EFFORT, YOU KNOW YOU HAVE TO WATCH OBVIOUSLY PEOPLE CAN INDULGE GRIEVANCES AND YOU KNOW YOU CAN SORT OF SPOT THAT BUT I THINK IN GENERAL, CONSCIENCE REVIEWERS WILL BELIEVE AT LEAST TO TRY TO OVERCOME THAT AND IT NEED NOT BE NECESSARILY. AGAIN I'M NOT A DIFFERENT PLAYING FIELD, HAVE YOU A MUCH, MUCH, BIGGER MORE SENSITIVE AREA. BUT I DON'T THINK THAT THAT IS NECESSARILY REQUIRED TO GET A FAIR EACH HANDED REVIEW. >> OKAY, WE'LL RETURN TO YOU IN JUST A MINUE BUT I THOUGHT MAYBE CATH YOU WOULD BE THE BEST ONE TO ANSWER THIS AND I SAW YOU NODDING WHEN STEVE MENTIONED THIS, IF THERE WAS A PREAPPLICATION PRECESS AND LIKE AN EXFERNAL STUDY SECTION AND THE ONES THAT GET THE SCORE AND THE ONES THAT DON'T, SOME PERCENTAGE MIGHT NOT BE HAPPY WITH THAT AND WANT TO SUBMIT THEIR FULL GRANT ANYWAY, THERE'S NO WAY TO STOP THAT. IS THAT CORRECT. IS THAT RIGHT? >> THERE'S GOING TO BE A% THAT WILL DO THAT, WE DONE KNOW WHAT THAT IS TILL WE DO THE EXPERIMENT, WOULD IT BE NOTED TO THE STUDY SECTION THAT WHAT THE RESULT OF THE PREAPPLICATION SCREEN WAS. >> IT WOULD BE INTERESTING TO KNOW WHETHER WE HAVE THE APPLICATION PROCESS WHETHER OR NOT PEOPLE WHO DID NOT DO WELL IN THE CYST ROUND ACTUALLY CAME BACK IN AND WE HAD A PREORDER APPLICATION TO MAKE SURE THAT THE THREE WAY COLLABORATION BETWEEN THE COMPANY AND THE INVESTIGATOR AND THE N IH WOULD ACTUALLY WORK AND SO WE DID HAVE A PREAPPLICATION PROCESS AND WE DID NOT GET TO THE BEST OF MY RECOLLECTION ANY OF THE PEOPLE WHO WE SAID WERE NOT INTERESTED. NONE OF THEM CAME BACK IN FOR THE SECOND STAGE. THAT WAS AN XO-TWO/THREE,. >> XO-TWO. >> YEAH. >> THAT WAS CREATED FOR THOSE KINDS OF PURPOSES AND YOU CAN HAVE EITHER ADMINISTRATIVE, PURLY ADMINISTRATIVE REVIEW, ASK FOR OUTSIDE OPINION WHATEVER WAY THE INSTITUTE FEELS THE BEST WAY TO LOOK AT THOSE XO2S AND AGAIN IT'S THERE'S ONLY BEEN CASE STUDIES, THERE HASN'T BEEN ENOUGH TELEVISION IF ESSENTIALLY FULL FLEDGED STUDY OF THE XO-TWO, AND OFTEN WHEN THE XO-TWO IS USED FOR A VERY SPECIFIC PROGRAM. SO SOME PEOPLE MIGHT BE THINKING IF THEY'RE LAUNCHING INTO BIG, BIG HUGE TRIALS OR A BIG EPI STUDY OR SOMETHING LIKE THAT, MY MIGHT WANT TO USE AN XO-TWO, O AGAIN A LOT OF CAVEATS HANGING OFF THIS BUT MY UNDERSTANDING TOO FROM DISCUSSIONS AT EPMC IS THE SAME AS WHAT CATHY SAID. AND THEY DON'T GET FEEDBACK, THEY CONTINUE THE PROCESS BUT THERE'S THE OCCASIONAL ONE THAT WILL. >> YEAH, BUT THE NETEFFECT MIGHT BE STRONGER APPLICATIONS IN THE DETAILED STUDY SECTION, THE OTHER IMPORTANT ABOUT THE XO-TWO IS IT DOESAD TIME SO IF WE'RE LOOKING AT THESE VERY LONG TIME SCALES FROM APPLICATION TO AWARD, IF HAVE YOU A DOUBLE APPLICATION CYCLE, XO-TWOS CAN BE REVIEWED INTERNALLY KDONE IN AN EXPEDITED WAY BUT IT IS AN ADDITIONAL TIME AND-- >> YEAH. LOOKS LIKE WE WILL GET TO YOU, BUT THERE'S SOME PEOPLE DYING TO JUMP INTO THIS. >> JUST IN THINKING ABOUT INVESTIGATORS THAT WORK IN A SMALL GROUP FOR FOUR OR FIVE YEARS AND ONE IDEA THAT THEY DEVELOPED, YOU WANT TO LEAVE OPEN AND I THINK THAT AS YOU ALL KNOW IT'S PRETTY BAD OUT THERE IS, AND AS DR. FOX ALLUDED TO WITHOUT MONEY, LABS ARE SHRINKING, PEOPLE ARE LET GO AND WE WANT TO BE AWARE OF THAT FOR YOUNG PEOPLE AS WE THINK ABOUT THIS. AND I THINK BIAS IS APPLICATION IS REAL AND ESPECIALLY LOAF THE IDEA OF A PRESCREENING PHASE OR PRELIMINARY PHASE IT'S SOMETHING WE NEED TO INVESTIGATE A LOT MORE. THE OTHER THING IS I THINK WE ARE TALKING ABOUT PREAPPLICATIONS AND PRESCREENING AND WE'RE NOT ALL TALKING ABOUT THE SAME THING. I'M HEARING SEVERAL TIME WHEN IS THIS IS DONE, AT OUR INSTITUTE WE DO MOST OF OUR PROGRAM AND WE REQUIRE A LETTER OF INTENT AND IT'S WE KNOW WHAT'S COMING SO WE CAN BE PREPARED FOR IT BUT THERE'S ALSO DISCUSSION THAT GOES ON THERE ARE TIMES WHERE THE PROGRAM PEOPLE MAY SAY, YOU KNOW I DON'T REALLY THINK YOU'RE ON TRACK WITH THIS AREA, I THINK THAT'S HELPFUL SO I'M KIND OF JUST SAYING, I'M HEARING DIFFERENT THINGS SOMETIMES I'M HEARING TELL BE DONE BY THE PROGRAM PEOPLE SO THESE ARE ALL ISSUES WE NEED TO INVESTIGATE THESE ISSUES MORE AND TALK ABOUT. >> POINT WELL TAKEN ESPECIALLY THE LAST ONE AND MAYBE WE CAN EXPLORE THAT IN A BIT MORE DETAIL EITHER--WE STILL HAVE WE HAVE QUITE A BIT OF TIME BEFORE FRANCIS CALLS AND LET'S RETURN BACK TO THE PAN AND HE WILL HAVE THEM SAY SOME THINGS. >> THIS IS PERFECT BECAUSE IT BRINGS UP A LOT OF THINGS I DID WANT TO GET ACROSS. SO FIRST OF ALL I COMPLETELY AGREE AND THERE IS ESTABLISHED BIAS AND IT'S NOT SOMETHING PEOPLE DO ON PURPOSE BUT IT'S IMPLICIT BUT EXISTS AND IT'S BEEN SHOWED FOR SEARCH COMMITTEES GIVEN THE IDENTICAL APPLICATION AND ONE IS MAIL IT'S MILLIONS OF YEARS OF EVOLUTION SO IT'S GREAT AS A PILOT STUDY TO SEE IF THIS IS EFFICIENT. THE DISCUSSION OF THE PREAPPLICATION IS INTERESTING BECAUSE THE PREPROPOSAL MAYBE TWO YEARS AGO AND HAS NOW ONLY A SINGLE APPLICATION CYCLE AND THE APPLICATION IN JANUARY AND FULL APPLICATION OF AUGUST AND I WOULD SAY, BASED ON MY OWN EXPERIENCE OF HAVING THESE MULTIPLE RO-1 UNSUCCESSFUL APPLICATIONS THE ONE THING THAT IS MOST DETRIMENTAL IS THE LACK OF DISCUSSION OF THE GRANT PROPOSAL IN THE STUDY SECTION MAKE THESE GO THROUGH THE APPLICATION PROCESS AND THEN HAVE YOU SOMETHING TO WORK WITH IN ORDER TO TURN IN A REVISED STRONGER APPLICATION IN THE FUTURE. IT IS AN EXTREME WASTE OF TIME TO WRITE WHAT I THINK IS A GREAT PROPOSAL, GO THROUGH COLLEAGUES WHO HAVE VETTED OUT TO TENTIAL ISSUES AND THEN GET IT IN A STUDY SECTION WHERE IT'S TRIAGED AND YOU DON'T GET ANY RESPONSE IN TERMS OF WHAT TO DO NEXT. SO I WOULD AGREE WITH THAT IF IT WOULD INCREASE THE NUMBER OF GRANTS THAT ARE DISCUSSED IN THE STUDY CYCLE. I HAD A FEW COUPLE OF OTHER IDEAS. I REALLY LIKE THE IDEA OF FUNDING PRINCIPLE INVESTIGATORS RATHER THAN PROJECTS. I THINK THIS PEEKS TO--I MEAN FROM A PERSONAL POINT OF VIEW, I THINK I'VE DONE WELL AT NSF FOR BROADER IMPACT WHERE IS THEY TAKE INTO ACCOUNT YOU AS AN INVESTIGATOR AND HOW YOU CONTRIBUTE TO SCIENCE. HOW YOU IMPACT THE BROADER NETWORK OF SCIENTISTS, YOUR OUTREACH ACTIVITIES, YOUR SERVING ON STUDY SECTIONS WOULD BE INCLUDED IN THIS SORT OF BROADER IMPACTS, I THINK IT WOULD BE A GREAT IDEA AND THEN SIMILAR TO THAT, OR RELATED TO THAT, IDEALLY IF EVERYONE COULD BE SUBJECT TO SOME KIND OF BASE RO-1 FUNDING WHERE AFTER YOU'VE BEEN SUCCESSFUL AT THAT FIRST RO-1, RATHER THAN HAVE TO CONTINUALLY RENEW A COMPETITIVE RENEWAL, WITH THE LARGE POOL, IF YOU CAN SHOW THAT YOU'VE MADE GOOD PROGRESS, YOU'RE A GOOD CITIZEN, YOU CONTRIBUTED TO THE SCIENTIFIC COMMUNITY, COULD THERE BE A DISTINCT MECHANISM OF JUST RENEWING THOSE GRANTS. SO THAT WOULD ELIMINATE A LARGE FRACTION OF THE GRANTS THAT GO INTO THE STUDY SECTIONS AND THEN THE SECTIONS COULD FOCUS A LOT MORE ON NEW INVESTIGATORS, THOSE INVESTIGATORS THAT NEED MORE HELP IN DEVELOPING AN INNOVATIVE PROPOSAL, AND OTHER ONES THAT LOST THEIR PROPOSAL AND NOW NEED TO RETURN TO GET THEIR LAB FUNDED. THAT I THINK WOULD BE GREAT. I MEAN MANY OF MY FACULTY COLLEAGUES SIT AROUND AND WE COME UP WITH THESE PIE IN THE SKY IDEAS BUT THIS WOULD BE ONE THAT WOULD BE WONDERFUL. AND THEN JUST AS AN ASIDE, IF THE GOAL IS TO DECREASE THE BUDDEN ON REVIEWERS, I HAD A COLLEAGUE COMMENT TO ME ONE TIME A FEW YEARS AGO THEY FOUND COMPENG THAT I WROTE THIS DOWN AND I KEEP IT IN MY OFFICE AND HE STATED THAT: WELL, IF THERE WERE NO DEADLINES THE NIH WOULD SAVE A LOT OF MONEY BECAUSE THIS WOULD DECREASE THE SORT OF WORKING TOWARDS THAT ONE DEADLINE AND YOU WOULD ONLY SUBMIT THE GRANT WHEN IT'S READY OR WHEN YOU THOUGHT IT WAS SUFFICIENT TO BE REVIEWED AND I LIKED THE IDEA OF THAT WAS INITIALLY IN THE ONES THAT WERE DISCUSSED OF ELIMINA DEADLINES, I THOUGHT THAT WOULD BE QUITE RADICAL AND THAT WOULD CLEARLY DECREASE THE NUMBER OF APPLICATIONS, I'M NOT SURE ABOUT THE OTHERS; THANK YOU. >> ACTUALLY TO THE LATTER POINT WE HAVE DISCUSSED THAT AND IT TURNS OUT OUR COLLEAGUES AT THE NIH TELL US THAT, YOU DON'T HAVE TO--THE DEADLINES DON'T MEAN ANYTHING. THEY'RE IMPORTANT TO THEM BECAUSE THAT'S WHEN THEY MOVE TOWARDS A GROUP OF APPLICATIONS AND MOVE THEM FORWAR, YOU COULD SUBMIT AT ANY DIME WE'RE TOLD, THE PSYCHOLOGY OF HAVING THE DEADLINE AND WORKING TOWARDS THE DEADLINE IS A REAL ONE. BUT THE FACT S&P YOU CAN SUBMIT A PROPOSAL AT ANY TIME. ANY OTHER--YEAH, LARRY? >> WELL I THINK THE DISCUSSION ON PREREVIEW IS INTERESTING. WE'RE CLEARLY THOUGH CONFLATING TWO ISSUES, ONE IS REVIEW TIME AND THE OTHER IS AND THE OTHER IS BURDEN OF WORK ON BOTH THE INVESTIGATOR AND THE REVIEWERS AND I WONDER IF THERE WOULD BE ROOM FOR AN EXPERIMENT OF SOME SORT. WHERE A VOLUNTARY FREE REVIEW WOULD BE OFFERED BY ONE OR MORE INSTITUTES AND THE RESULTS OF THAT PREREVIEW WOULD OBVIOUSLY BE MADE KNOWN TO BOTH THE APPLICANT AND THE SUBSEQUENT STUDY SECTION AND YOU KNOW AN APPLICANT CAN TAKE THAT INFORMATION IF IT'S UNFAVORABLE AND SAY I WILL GO BACK AND REWORK THIS PROPOSAL OR MAY BE I SHOULDN'T SUBMIT IT AT ALL AND THINK ABOUT SOMETHING ELSE AND SIMILARLY, THERE WILL BE A LLE BIT OF INFORMATION CONVEYED TO THE STUDY SECTION THAT WOULD ALLOW THEM TO PERHAPS BE DEALING WITH MORE EFFICIENT, WELL STRUCTURED PROPOSALS. IT WOULD BE INTERESTING AND YOU COULD SEE WHAT HAPPENS THAT WAY WITHOUT CHANGING THE ENTIRE SYSTEM. >> JUST AGAIN, THINK ABOUT THIS TOO FROM THE POINT THAT RAQUEL MENTIONED IT TOO, THE ANALOGY OF JOURNALS AND YOU WANT TO DO A PRESCREENING TO SAVE THIS PRECIOUS POOLS OF REVIEWERS, AND IT SEEMS THAT WHAT'S REQUIRED IS A VERY EFFICIENT EARLY STAGE, IT'S VERY EFFICIENT TO HAVE A COUPLE OF EDITORS LOOK AT IT, I'D MUCH IT GET RESKWREBGED QUICKLY THAN SLOWLY AND WHEN YOU GO TO REVIEWERS IT'S INCREASING AWARENESS IT'S MADE A CUT AND THIS IS SERIOUS AND YOU BUILD THAT REPUTATION UP THAT WE HAVE TO LOOK AT EVERY WORD OF THIS ONE BECAUSE SOMEBODY THOUGHT IT PASSED MUSTER AND AS I SAID, I KNOW IT'S NOT AS COMPLICATED, NOT MONEY ON THE LINE BUT I DO THINK THAT, I ALMOST ALL MAJOR JOURNALS NOW HAVE--AT LEAST, I THINK IT'S A STEADY ILLEGALSY MOVING TREND TOWARDS SENDING IT OUT TO FULLY REVIEW AND THERE AGAIN MAY BE USEFUL ANALOGYS, AND WE IN THE LAST MEETING ON FRIDAY, THAT ANALOGY WAS EXACTLY THE ONE WE USED IN DISCUSSING THIS ASPECT OF IT. LARRY'S POINT WAS APPRECIATED AND THE NONFEDERAL SIDE OF ONE-SIZE-FITS-ALL AND HOW COMPLICATE TODAY IT IS THE CULTURES IF YOU THOU THEY DO THINGS AND LARRY'S IDEA HAS A LOT OF MERIT THAT WE MIGHT TRY OUT SOME EXPERIMENTS AND WHAT COULD EMERGE THAT THE WORKING GROUP WILL WILL DEFINE THESE EXPERIMENTS AND WITH THAT INFORMATION IT WILL TAKE TIME TO AKAOUPLTULATE DATA AND MAKE MORE WHOLESALE CHANGES ACROSS THE NIH THAT WE KNOW HAS VALUE AND ACTUALLY CAN WORK. SOUTH AMERICA SCOTT. >> THE DOCTOR BROUGHT UP A SOLUTION AND FROM HIS PERSPECTIVE OF HOW TO ADDRESS THE PREAPPLICATION PROCESS, I WILL USE THIS CONCEPT TO ADVOCATE FOR ONE OR TWO PROCESSES IN THE SAME, ONE WAS THAN ONE WHICH WAS BASICALLY GO TO AN EDITORIAL TYPE REVIEW BOARD WHO WAS RESPONSIBLE FOR THE PREAPPLICATION PROCESS AND THEN LET THE ACTUAL STUDY SECTION BE THE ARBITERS OF THE FULL APPLICATION PROCESS. ANOTHER THING I'M TRYING TO THINK OUT OF THE BOX HERE AND IT MAY BE A BALLOON THAT WILL POP QUICKLY IS THAT IF WE GO AND WHAT WE'RE GOING TO TALK ABOUT THE MERITS OF GOING FROM THREE-TWO CYCLES, IF YOU ACTUALLY HAVE AND SAY ADVOCATED FOR THE TWO CYCLE FIST YOU ACTUALLY HAD TRIGGERED 20 COMMITTEES ON EACH ONE OF THOSE CYCLES, IN WHICH AND AGAIN I'M TRYING TO FIGURE OUT A WAY TO SHORTEN THE TIME FOR THIS WHOLE APPLICATION PROCESS SO THAT IN--IF HAVE YOU HAVE I TWIN COMMITTEE THAT IS BASICALLY LOOKING AT THE SAME DISCIPLINE, AND IN ANY ONE OF THESE BUDGET CYCLES, THE FIRST GROUP AS A PERCENTAGE OF THESE APPLICATIONS THAT THEY ACTUALLY DO THE PREAPPLICATION AND THEN THE REST OF THE TIME THEY'RE WORKING ON THE FULL APPLICATIONS AND THEY'RE OBVIOUSLY DIFFERENT. BUT IF GETTING BACK TO WHAT THE DOCTOR SAID, THE TIME FROM DOING A FULL GROUP PROCESS AS A RIVIEW AND SORT OF A YES-NO TO GO AHEAD, THEN IT'S GIVEN IMMEDIATE FEEDBACK TO THE GROUP AND THEN THEY HAVE THE 30 DAYS TO PUT THE FULL APPLICATION TO GO THEN TO THE TWINS SECOND GROUP TO REVIEW THE FULL APPLICATION PROCESS. SO THAT AGAIN, IT DOESN'T CAUSE AN EXCESSIVE AMOUNT OF ADDED BURDEN TIME SO YOU TAKE THE PREAPPLICATION PROCESS AND ONE, GOING TO THE SECOND CYCLE, YOU JUST TRY TO REDUCE THIS GOING FORWARD. SO IT'S JUST A--YOU KNOW A PROPOSAL AND I DON'T KNOW IF IT HAS ANY MERIT. >> GIVEN THE IMPORTANCE OF QUALITY PEER REVIEW, WHAT IS THE ARGUMENT AGAINST REQUIRING GRANT RECIPIENTS TO SERVE AS PEER REVIEWERS IF ASKED. ONE THING I CAN THINK OF IS THAT MAYBE WE'RE DOING SOMETHING THAT IS ABSOLUTELY SO IMPORTANT AND VALUABLE, YOU DON'T WANT TO DIVERT THEM FROM IT, AND YOU DON'T NEED TO ASK THEM AND WHAT'S THE ARGUMENT AGAINST THAT, WHY DO WE DO THAT. >> I ASKED THAT SAME QUESTION. WE CAN STRONGLY ENCOURAGE, WE CAN HAVE IT AS I'VE BEEN TOLD AS A CONSIDERATION FOR EXAMPLE FOR MERIT AWARDS, WHICH ARE--WHICH ARE VERY SPECIAL AWARDS. BUT TO REQUIRE IT IF ASKED, I KEEP SAYING IF ASKED BECAUSE THERE ARE SOME PEOPLE WHO REALLY MAYBE OUTSTANDING SCIENTISTS, SO CRITICAL OF EVERYTHING THAT THEY CAN'T SEE ANYTHING BUT THEIR OWN WORK BEING WORTH WHILE AND THEY CAN QUENCH ANYTHING. BUT I DON'T KNOW THAT THERE IS ANYTHING THAT DOESN'T ALLOW US TO DO IT ALTHOUGH WE ARE GIVING GRANTS AND AIDS SO WE'RE NOT REALLY PAYING PEOPLE AND DELLA IS HERE, DELLA KNOWS THE ANSWER, ACTUALLY I WOULDN'T HAVE SAID ANYTHING-- >> IT'S QUITE ALL RIGHT. YOU'RE DOING A GREAT JOB. SO THE DIFFICULT SEWHEN WE MOVE INTO LANGUAGE OF HIGH EXPECTATION, SO WE CAN DO ALL THE EXPECTATIONS WE WANT AND IN FACT, I BELIEVE WE ARE ACTUALLY GOING TO TRY TO RATCHET UP IN TERMS OF OUR LANGUAGE AND PROSE AND SO FORTH WITH REGARD TO EXPECTATIONS THAT IF YOU'RE CALLED UPON TO REVIEW THAT YOU WILL REVIEW, SO WE CAN HAVE THE EXPECTATION. THE REQUIREMENT--BUT TO MOVE FROM THAT INTO A REQUIREMENT IS WHERE WE GET A LITTLE HUNG UP. WE OFTEN TO MOVE INTO THAT ARENA, ONE HAS TO LOOK AT BASIC AUTHORITIES, LEGAL AUTHORITIES AND MY UNDERSTANDING IS WE HAVE NO LEGAL AUTHORITY ON WHICH TO HANG SUCH A REQUIREMENT AT THIS TIME. >> SO I ACTUALLY AM GOING TO DISAGREE A LITTLE ON THE IDEA THAT WE DON'T ASK CERTAIN PEOPLE BECAUSE THEY'RE SO CRITICAL OR TERRIBLE REVIEWERS, I LOVE RAQUEL'S SUGGEST THAN THAT WE WOULD PUT SOMETHING ON A BIOSKETCH WHERE PEOPLE WOULD--PEOPLE DO PUT ON THEIR BIOSKETCH THAT THEY REVIEW FOR ALL KIND OF JOURNALS, WHY NOT ON THE BIOSKETCH THAT THEY'RE REVIEWING FOR GRANTS AND I DO THINK THAT THERE'S NOTHING WRONG BUT I THINK IT'S AN EXPECTATION. BEING A GOOD CITIZEN INCLUDES PEOPLE HIGHLY CRITICAL IS PART OF ARE AND I REALLY DO THINK THAT CITIZENSHIP IS IMPORTANT AND WOULD BE SOMETHING THAT WE SHOULD BE LOOKING AT AS WELL. >> YEAH JUST A QUICK COMMENT AND THIS IS A COMMENT I MADE ON THE PHONE TODAY, IT'SUANT CITIZENSHIP AND THAT REVIEW PROCESS GETS BETTER WHEN THE REQUIREMENT IS THAT EVEN ALL THE SENIOR PEOPLE IN AN ORGANIZATION WHETHER IT BE DEPARTMENT CHAIRMAN, ALL THE WAY DOWN TOLET LOWER LEVEL ENTRY GRANTEE PARTICIPATE NOTHING THE PROCESS, AND AS I INDICATED, ALSO INTRAMURAL AS WELL BECAUSE I THINK IT WILL ALLOW FOR BETTER ENGAGEMENT ACROSS THE BOARD OF GOOD IDEAS AND I THINK IT WILL HELP, THE WHOLE INDUSTRY MEETING RESEARCH AND OUTCOME AS AN RESULT. THE UNINTENDED CONSEQUENCE MAY BE THAT SOME PEOPLE WON'T BE ASKED BECAUSE THEY WORK IN A VERY OBSCURE FIELD OR WHATEVER SET, AND THEN BECAUSE THEY AREN'T IDENTIFIED AS HAVING CONTRIBUTED, THEIR APPLICATIONS WILL NOT BE REVIEWED FAVORABLY AND I THINK THAT'S A BIT OF A RISK HERE. I GIST SAID HERE, IT'S NOT EASY, AND THERE'S A FAIR AMOUNT OF THE DAY TO GO BUT THAT ONE WILL SURVIVOR. NANCY? >> I DO THINK THOUGH THAT HAVING AT LEAST SOME MEETING THAT ARE NOT FACE-TO-FACE. I RECOGNIZE THE VALUE OF FACE-TO-FACE. BUT BIG PART OF THE PROBLEM WITH MAKING THIS COMMITMENT IS BEING ABLE TO TRAVEL TO FIXED MEETINGS OR MAIL REVIEWS OR VIRTUAL REVIEWS MAY HELP US. >> YEAH, COMING BACK TO THE JOURNAL ANALOGY, AND I--I CAN'T REMEMBER IF I SAID THIS ON FRIDAY OR NOT, WHICH IS SAD, INDICATIVE OF ANOTHER PROBLEM. [LAUGHTER] SO I'M A SENIOR EDITOR ON THE LIFE, MAYBE SHOULD HAVE YOU HAD EXPERIENCE WITH TI HOPE POSITIVE. SO PAPERS GET SUBMITTED AND THEY GO TO A SENIOR EDITOR AND THERE'S A VERY, VERY NICE SOFTWARE PACKAGE WHERE YOU CAN ASK THE NEXT LEVEL OF EVALUATION WHICH IS A BOARD OF REVIEWING EDITORS THIS CASE YOU YOURSELF CAN'T DECIDE, CAN YOU STIMULATE A DISCUSSION AMONG YOURSELF AND ONE OR TWO OR THREE OTHER PEOPLE ABOUT THE MERIT OF THE PARTICULAR PAPER, IT HAPPENS IN A SHORT AMOUNT OF DAYS OTHERWISE RANDY SHECKMAN WILL BE ALL OVER YOU. AND THE PAPER CAN COME IN AND GET REVIEWED AND THEY'RE WITH OTHER PEOPLE AND THEY'RE SCIENTISTS AT LARGE AND THEY REVIEW THE MANUSCRIPT AND THEY HAVE A REALTIME DISCUSSION, I MAN, SO FOR EXAMPLE, IF SOMEBODY SAYS, YOU KNOW FIGURE FOUR DOESN'T MAKE SENSE TO ME AND THAT'S REVIEWER NUMBER TWO, REVIEWER NUMBER WILL SAY, WELL YOU KNOW THE AXIS IS NOT LABELED CORRECTLY BUT HERE'S WHAT THE FIGURE IS ABOUT AND YOU CAN SEE HOW THIS IS GOING TO GO, AND IT TURNS OUT, AGAIN BECAUSE THE IDEA IS BOTH SPEED AND SCIENTISTS DOING IT. THAT IN A SHORTER PERIOD OF TIME, YOU GET ONE REVIEW. ONE REVIEW, TYPICALLY THREE, THOSE PEOPLE MAY NOT KNOW EACH OTHER BUT OFTEN THEY DO BUT THEY DON'T HAVE TO. CERTAINLY NOT FACE TO FACE. BUT IT WORKS. IT WORKS VERY WELL AND FROM THE PERSON WHO SUBMITTED THE PAPER, YOU--WHAT YOU DON'T END UP WITH IS THAT--THAT OUTLIER REVIEW, THAT YOU GET TO SO ANGRY BECAUSE THEY COMPLETELY MISUNDERSTOOD THE PAPER BECAUSE CHANCES ARE THAT THAT WAS--CAME OUT IN THE WASH ONCE YOU WENT AROUND THE BLOCK A FEW TIMES WITH THESE THREE REVIEWERS, SO THE POINT OF THAT IS NOT THAT IT'S IMMEDIATELY EXPORTABLE TO SOME OF WHAT WE'RE TALKING ABOUT HERE BUT THERE ARE ALTERNATE WAYS AND NANCY'S ENCOURAGED BY HER LAST COMMENT ENCOUR ME TO SAY THIS, BUT THERE ARE ALTERNATE WAYS TO THINK ABOUT HOW WE EVALUATE AND REDO THESE REVIEWS AND IT DOESN'T ALWAYS HAVE TO BE IN THE SAME ROOM AND IT DOESN'T HAVE TO BE A HIGH QUALITY OUTCOME AND WE HAVE TO HAVE AN OPEN MIND ABOUT THAT ESPECILY IF WE'RE GOING TO TRY AND AN INCREASE THE NUMBER OF PEOPLE THAT WE ASK TO COMMIT THEIR TIME TO REVIEW. >> I WAS THINKING ABOUT THE EXPERIMENT, IF THERE WAS SOME KIND OF EQUIVALENT OF AN EDITORIAL RESRORD AND SAY TWO OR THREE PAGE DOCUMENT, COMING IN, AND HAPPY TO BE ANONYMOUS AND THAT'S FINE AND HAVING EITHER YOU KNOW--YOU BE LIKE ELECTRONIC OR EVEN PHONE DISCUSSION, I THINK THAT WOULD BE FUN. I THINK THAT WOULD BE REALLY INTERESTING TO BUILD LIKE, YOU KNOW A SORT OF A GROUP AND GIVING THE SORT OF HEARING WHAT YOUR COLLEAGUES WERE THINKING, NEW IDEAS. IT WOULDN'T BE HONEST WITH YOU AS SLOGGING THROUGH THE DESAILS BUT IT'S SAME AS SOCIETY, THIS COULD GO ANYWHERE, I THINK THAT AGAIN I THINK REDUTIESING THE BURDEN AND TAKING THE TRAVEL ISSUE OUT OF IT, I THINK THAT INCREASINGLY, WE KEEP FINDING NEW WAYS TO SORT OF WORK THINGS OUT IN MODERN TECHNOLOGY THAT REALLY REDUCES THE BURDEN AND MAINTAIN THE PRODUCT. I DON'T KNOW IF AT THE LAST STAGE--I'M OLD FASHIONED ENOUGH TO BELIEVE THAT WHEN IT GETS REALLY, REALLY SERIOUS THAT GIVE AND TAKE ACROSS THE TABLE IS PRETTY IMPORTANT, BUT FOR THAT VETTING OF IDEAS, THE BOUNCE AROUND, WHAT DO YOU THINK OF THIS, I THINK THAT--I THINK THERE'S A LOT TO BE SAID AND I THINK IT WOULD APPEAL TO REVIEWERS AS I'M SAYING AS A PERSON THAT MIGHT GET DRAWN UPON, I THINK THAT WOULD BE MUCH LESS INTIMIDATING THAN SIGNING UP FOR THE STUDY SECTION. >> YEAH AND A WAY TO ENGAGE SENIOR PEOPLE BACK INTO THE PROCESS IN A WAY THEY WOULD FIND QUITE INTERESTING. >> [INDISCERNIBLE] IN THE STUDY SECTION THAT COME HAVE CONSIDED MERIT ARE THOSE THAT ARE REALLY GOING OUTSIDE THE BOX IN THE FIELD AND THE PULLING TOGETHER A GROUP OF INVESTIGATORS TO ADDRESS A SPECIFIC QUESTION AND IT MIGHT BE MOTIVATING REVIEWERS ON I GENETIC GRANT, IT CAN BE THREE OR FOUR OR FIVE WITH EXPERTS COME NOTHING AND ONE TIME ONE OF THE BLOW SYSTEM SO FATAL THAT MOW MATTER THE GREATEST IDEA, THEY WILL NEVER BE ABLE TO GET THE POPULATION LIKE THAT SO IT'S SO RARE AND THERE'S NO ANYTHING ABOUT OPENLY COLLABORATE AND GET THE SIMPLE, AND ONE OF THEM WAS THE EXPERTISE WILL THINK WHAT IS THE FREQUENCY, IT'S WOBDERFUL GENETIC BUT YOU WILL GET 10 PEOPLE, YOU KNOW? MAYBE A YEAR AND THERE'S NO FEASIBILITY THAT THEY EVER DEALT WITH IT, NO LETTER OF SUPPORT. YOU SAVE A LOT OF TIME IN THE DISCUSSION. >> OTHER COMMENTS? GREAT DISCUSSION. THANK YOU FOR STIMULATING IT. WE HAVE--I WILL TURN BACK TO OUR CHAIR. WE HAVE A FEW MINUTES HERE, YOU WANT DECIDE HOW YOU USE IT. >> YOU'VE DONE SUCH A GOOD JOB. THANKS TO THE PANEL ESPECIALLY. THE VIEWS YOU BRING ARE EFORM AUSLOW HELPFUL AND WE'RE APPRECIATIVE. WE NORMALLY DON'T TAKE MERCY BREAKS BUT SINCE YOU'VE DONE SO WELL, MICHAEL, I THINK WE REALLY DO NEED TO BE BACK BY 10 OF BECAUSE I UNDERSTAND FRANCIS WILL CALL IN. SO WHY DON'T WE TAKE A BREAK IF EVERYBODY CAN BE BACK AT YOUR PLACE BY 10 OF, THAT WOULD BE TERRIFIC. WE JUST TOOK A BREAK AND WE'RE RIGHT ON TIME. THE FLOOR IS YOURS AND THANK YOU FOR CALLING FROM LONDON. >> THANK YOU FOR TOLERATING MY CALLING IN INSTEAD OF BEING THERE IN PERSON WHEN KHI IS WHAT I WANTED TO DO TODAY IS THE MEETING OF THE GLOBAL ALLIANCE FOR CHRONIC DISEASE AND TOMORROW IS THE MEETING OF THE INTERNATIONAL HEADS OF ORGANIZATIONS WHICH BRINGS TOGETHER THE MAJOR CEOs OF FUNDING AGENCIES FOR PUBLIC SUPPORT OF BIOMEDICAL RESEARCH, WE GET TOGETHER ABOUT EVERY SIX MONTHS IN ONE PLACE OR ANOTHER AND I'M CURRENTLY A CHAIR SO I KIND OF HAVE TO BE HERE BUT I'M SORRY NOT TO BE THERE WITH YOU AND SORRY TO HAVE MISS THE DISCUSSION THIS MORNING ABOUT GRANT AND THE CONVERSATION WE WILL HAVE THIS AFTERNOON ABOUT THE COLLEGE EDUCATION I COULDN'T PASS UP THE CHANCE TO SAY THAT EVEN THOUGH THE TIME SUGGEST OFF FOR THE REST OF THE DAY, TO CALL IN AND SAY A FEW WORDS OF APPRECIATION TO NORM THAT CAN WE BELIEVE IT, THE OPPORTUNITY TO SERVE AS CHAIR OF A DISTINGUISHED GROUP AND LED IT IN SUCH AN EFFECTIVE WAY. NORM I KNOW THERE'S GOING TO BE A BIT MORE CELEBRATION OF YOUR ACCOMPLISHMENTS THAT WE WILL BE PLANNING TO SAY SOMETHING AT THE END OF THE DAY. AT THAT POINT I'LL BE IN THE MIDST OF A WORKING DINNER AND THAT PIECE SO I'M BARGING RIGHT IN RIGHT NOW AS WE'RE TRYING TO GET WORK DONE. SO THANK FOR LETTING ME DO SO. FOR THOSE OF YOU WHO HAVE NOT NECESSARILY HAD THE PRIVILEGE OF WORKING WITH LONG OVER MANY DECADES YOU MAY NOT QUITE REALIZE WHAT A REMARKABLE CAREER HE HAS HAD AND THE EXPERIENCE THAT HE BRINGS FROM THAT TO THIS SMRB, AS YOU KNOW AS LOS ANGELES AS RETIRED CHAIRMAN AND CEO OF LOCKHEED MARTIN. DID YOU KNOW HE WAS FORMERLY UNDER SECRETARY OF THE ARMY BACK IN 1970. DID YOU KNOW HE WAS A MEMBER OF THE DEPARTMENT OF HOME HRABD SECURITY PSYCHIATRIST DEPARTMENT WHICH IS A BIG HEADACHE RIGHT NOW AFTER ESPECIALLY AFTER WHAT THE APPROPRIATES WANTED TO DO WITH HOMELAND SECURITY IN A SPECIAL CATEGORY FOR THAT, OH BOY. I SUSPECT MANY OF YOU ARE AWARE THAT HE WAS THE CHAIR OF THE PANEL THAT PRODUCED THE DRAMATIC REPORT IN 2005 CALLED RISING ABOVE THE GATHERING STORM IN WHICH I THINK REALLY ENERGIZED A LOT OF CONSTITUENTS SO WE HAVE TO DO SOMETHING TO TURN AROUND WHAT HAD BEEN A SLIDE DOWNWARD IN TERMS OF SUPPORT OF SCIENCE AND ENCOURAGEMENT OF THAT DOCUMENT AND UNFORTUNATELY, THE MORE RELEVANT THAN THEY BROUGHT IN BECAUSE IT CONTINUES THE SOCIAL AND BIOMEDICAL RESEARCH, AND YOU MAY NOT KNOW THAT ONE OR MORE OF THESE NATIONAL MATTERS OF TECHNOLOGY AND MORE OR LESS SIDES AND DEPARTMENT OF STUFF THAT HE SERVED AS CHAIRMAN IN THE OFFICER OF THE AMERICAN RED CROSS, PRESIDENT OF THE BOY SCOUTS OF AMERICA, OH MY GOODNESS, I CAN GO ON. HE'S WRITTEN A COUPLE OF BOOKS WHICH I HAVE BROWSED IN THE PAST AND I DID READ THEM AGAIN ALTHOUGH I DIDN'T SAY [INDISCERNIBLE] ONE'S CALLED AUGUSTINE'S LAWS AND ANOTHER CALLED AUGUSTINE'S TRAVELS MAKING WE WONDER NORM, WHAT'S NEXT? AUGUSTINE'S CONCESSIONS? SO THAT'S ALREADY TAKEN--PERHAPS ANOTHER ONE. [LAUGHTER] BUT I DO WANT TO SAY SOMETHING ESPECIALLY ABOUT NORM AS HIS ROLE OF CHAIR OF THE SMRB BECAUSE HE HAS BEEN THE CHAIR SINCE THE FIRST BEGINNING OF THE FIRST MIGHTING OF APRIL 2 THIS HAPPENED NINE, ABOUT FIVE AND HALF YEARS AGO AND HE HAS PRESIDED OVER NO LESS THAN 24 MEETINGS AND CONFERENCES AND IN A REAL REMARKABLE WAY, LET ME JST MENTION A FEW REPORTS THAT HAVE BEEN USED, THEY'RE NOT PRIVATE SECTORIAL PRODUCES BECAUSE THEY'RE PAINFULLY AWARE OF THE LEGISLATION THAT INCREASE THIS REQUIREMENT AND MEET THIS TOPEC AND A RECOMMENDATION WAITING FOR THAT TOPIC SO THAT WAS CERTAINLY A LOT OF DISCUSSION AND NOTHING GETS RUSHED INTO THIS FORMAT AND NORM, BACK AT THE VERY BEGINNING OF THE SMRB EFFORTS, DUE TO RATHER EMBRACED THE DELIBERATATIVE NATURE BY FIRST HAVING A MEMBER OF THE PROCESS AND PRODUCED THOSE DOCUMENT THAT CONTINUES TO BE A USEFUL GUIDE NOT JUST FOR NIH BUT OTHER AGENCIES OR ORGANIZATIONS AS WELL, THEY KUHL [INDISCERNIBLE] OR ORINIZATION AND EFFECTIVENESS WHICH CONTINUES TO BE AN IMPORTANT TOUCHDOWN FOR US, SMRB WENT ON TO HAVE THE NICE CLINICAL SECTOR AND THAT LED NIH TO ISSUE AND FUNDING OPPORTUNITY ANNOUNCEMENT TO ENCOURAGE THE USE OF CRITICAL CENTER RESOURCES MORE WIDELY, AND THE MECHANISM THAT IS NOW FUNDED AND ACTUALLY SUPPORTING SOME PRETTY INTERESTING SCIENCE THAT INVOLVES INTRAMURAL AND EXTRAMURAL COLLABORATION. A PARTICULARLY IMPORTANT MOMENT, MOST OF THEM FIVE TAMES, DID YOU EVER [INDISCERNIBLE] RECOMMENDATIONS ON TRANSLATIONAL MEDICINE AND THERAPEUTICS AND ADVISED ME ON THE NEED FOR NEW CENTER, AND FOCUSED ON SUPPORTING AND STRENGTHENING TRANSLATIONAL MEDICINE AND FROM THAT RECOMMENDATION WE CREATED THE CAPS COMPONENT AND THE NEW INSTITUON HAD BEEN CREATED WITHIN NIHOT BASIS OF SCIENTIFIC RECOMMENDATIONS, FOR THE NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCE WHICH I THINK CONTINUES TO BE A WONDERFUL EXCITING PLACE FOR CUTTING EDGE SCIENCE TO HAPPEN, SMRB HAD A SIGNIFICANT ROLE IN THIS RELATION ABOUT WHAT WE DO. NEXT IS A REPORT ON SMALL INNOVATIONS BUSINESS RESEARCH AND THE FDIR AND THE PTR AND THAT RECOMMENDATION TO OPTIMIZE THE PROGRAMS WAS IN FACT VERY WELL TIMED. I THINK I JUST SAW A NOTE FROM SALLY ROCKY ABOUT HOW WE'RE COMPLEMENTING THIS, DOING A NUMBER OF THINGS BUT SHORTEN THE TABLE AND REALIZE THAT MANY OF OUR FOCUSES ARE WORKING AGAINST THE CLOCK [INDISCERNIBLE]. AND THEN EARLIER THIS YEAR, THE MEMBERS FINALIZED THE REPORT ON APPROACHES TO ASSESS THE VALUE OF BIOMEDICAL RESEARCH ASK IMPORTANT TOPIC WE'RE OFTEN ASKED ABOUT THIS, I'LL BE DISCUSSING THAT REPORT TOMORROW HERE IN LONDON IF WE HAVE INTERNATIONAL [INDISCERNIBLE] VERY ENGAGED IN WAYS TO MAKE THIS CASE AND THEN THE TWO THAT ARE STILL ON YOUR AGENDA TODAY, THE GRANT REVIEW, ALERT MANAGEMENT PROCESS, I KNOW WE'VE BEEN DISCUSSING, I LOOK FORWARD TO SEEING THE RECOMMENDATIONS EMERGE IN THAT SPACE ABOUT HOW TO ADDRESS THE TIME AND EFFORT FOR THE REVIEWERS AND APPLICATIONSLICANTS AND STAFF AND ADMINISTRATORS WHILE KEEPING THE HIGH QUALITY OF THE PROCESS, AND I BOOK REPORT THAT YOU WILL VOTE ON UNLESS SOMETHING GOING WRONG, AND THAT IS THE [INDISCERNIBLE] ENGAGEMENT THIS IS A TOPIC THAT IS NEAR AND DEAR AFTER NORM'S HEART. SO WHEN I THINK ABOUT THAT TRACK RECORD OVER [INDISCERNIBLE], IT IS A VERY IMPRESSIVE ONE AND IT'S A TESTIMONY TO ALL THE MEMBERS OF THE SMRB OF A PARTICULARLY [INDISCERNIBLE] OR PARTICULARLY LEADERSHIP ABOUT WE HAVE COME THIS FAR. I JUST WANT TO SAY, NORM IT HAS BEEN AN ABSOLUTE PLEASURE TO WORK WITH YOUR PERSON. YOU HAVE BEEN WILLING TO THINK ABOUT NEW DIRECTIONS, YOUR SENSE OF HUMOR CARRIES US ALONG WHEN WE NEED IT AND IT'S JUST BEEN AN HONOR TO HAVE YOU AT THE HELM OF THIS AND I MUST SAY NOT TO GO OWL BIBLICAL ON YOU HERE BUT IT DOES SEEM TO ME THAT YOU HAVE LEADED AND SUCCEEDED IN COMBINING BOTH THE BUSINESS PROGRAMS DOM OF SOLOMON AND THE PATIENCE OF JOB TO GET THE WORK DONE THAT WAS PRESENT INDEED FRONT OF YOU. SO THANK YOU MY DEAR FRIEND. I LOOK FORWARD TO SEEKING OUT YOUR ADVICE IN OTHER WAYS IN FUTURE BUT I KNOW I WILL WANT TO LEAN ON YOUR WISDOM AGAIN IN OTHER WAYS BUT WE ARE ALL SO DEEPLY IN KWROURT DEBT FOR THE TIME, EFFORT, LEADERSHIP AND EVERYTHING YOU PUT INTO THE SMRB OVER THESE FIVE YEARS. THANK YOU FROM THE BOTTOM OF MY HEART. >> LFRANCIS, THANK YOU. THAT WAS UNNECESSARY AND IT WAS VERY THOUGHTFUL FOR YOU TO CALL OWL THE WAY FROM LONDON IN THE MIDDLE OF WHAT YOU ARE DOING. IT'S BEEN MY PRIVILEGE AND ESPECIALLY THANK YOU FOR THE PLUG FOR MY BOOK. ANYBODY HAPPENS TO HAVE A COPY, LET ME CONGRATULATE YOU ON BEING A MEMBER OF A VERY SELECT SMALL GROUP. BUT FRANCIS OF COURSE, KNOWN OF YOU BY REPUTATION BUT I DON'T THINK WE MET UNTIL I TOOK THIS RESPONSIBILITY ON, AND I'M JUST AMAZED AT YOUR LEADERSHIP AND SCIENTIFIC ABILITY AND YOUR PERSONAL QUALITIES, BEEN A PRIVILEGE TO WORK WITH YOU, I'M STRUCK BY THE DIFFICULTY OF THE JOB AND YOU ARE DEALING WITH IT, 22% REAL DOLLAR BUDGET CUT SINCE THE PEAK AND AT THE SAME TIME THE PEOPLE WHO WANT TO CUT YOUR BUDGET WANT TO KNOW WHY YOU HAVEN'T SOLVED EBOLA IN 24 HOURS. >> HA HA, YES! >> AND CLEARLY AN ENORMOUS CHALLENGE THAT YOU FACE BUT YOU'RE NOT RID OF ME. I MENTIONED BEFORE THAT IN WHATEVER RUNWAY I HAVE LEFT IN LIFE, MY TWO TOP PRIORITIES ARE TO TRY TO HELP IMPROVE AMERICA'S K-12 EDUCATION AND THE SECOND ONE IS GET INVESTMENT IN THIS COUNTRY IN RESEARCH AND IN THE LAST LATTER REGARD, I SPENT SEVERAL DAYS, ON CAPITOL HILL TALKS TO SENATORS ON THE SUBJECT OF INCREASING SUPPORT FOR RESEARCH AND FRANCIS AS YOU KNOW IT'S A FRUSTRATING TASK BECAUSE NOBODY'S REALLY AGAINST YOU BUT IT'S NOT AT THE TOP OF ANYBODY'S LIST. AND I THINK ONE AS TO VIEW HOLDING YOUR OWN AS A VICTORY IN THIS ENVIRONMENT, THAT'S THE ONE THING THAT KEEPS YOU GOING. BUT I WAS POINTING OUT THE SUBJECT OF BIOMEDICAL RESEARCH THAT IN THE LAST CENTURY WE TOOK LIFE EXPECTANCY IN THIS COUNTRY FROM 49 YEARS TO 79 YEARS MUCH OF WHICH I THINK COULD BE SHOWN TO BE DUE TO ADVANCEMENTS IN BIOMEDICAL RESEARCH. ACTUALLY I WAS TESTIFYING FRANCIS AND AS I POINTED THAT OUT, IT SUDDENLY OCCURRED TO ME THAT I'M 79 YEARS OLD. AND SO--[LAUGHTER] --I TOLD OF THAT AND SAID THAT THIS IS REALLY URGENT, LET'S GET ON, SO FRANCIS IS YOU GET BACK TO WORK AND THANK YOU FOR YOUR THOUGHTFUL AND AND HAVE A GREAT TRIP. >> THANK YOU. THANKS FOR WHAT YOU'RE DOGOT HILL AND THAT WONDERFUL REPORT THAT AND YOU ELAINE PUT TOGETHER. YES, FAIR NOTE EFFORTS, TURN ALL OF THOSE WONDERFUL CREATIVE AND COMCOMPETTING ARGUMENTS THAT YOU'RE A MASTER OF AND WE WILL HOPE FOR THE BEST. FY16 WILL BE THE YEAR, LET'S HOPE SO. >> WELL I WILL STAY WITH IT, YOU TAKE CARE. >> OKAY, THANKS, EVERYBODY, BYE-BYE. >> YOU BET. WILL WELL, THAT WAS VERY THOUGHTFUL FELT NOW WE WILL HAVE WHAT WILL BE OBVIOUSLY TIMELY BUT VERY FASCINATING DISCUSSION OF WHAT NIH IS DOING ON THE SUBJECT OF THE EBOLA OUTBREAK. ONCE AGAIN THESE THINGS, IT'S FUNNY HOW THEY IMPACT YOUR LIFE. ABOUT A YEAR AGO MY WIFE AND I PUT DOWN A THIRD DEPOSIT ON A--ONE PART OF THE WORLD WE NOT TRAVELED IN MUCH IS THE WEST COAST OF AFRICK AWE HAD SIGNED UP ON A CRUISE TO HIT EVERY COUNTRY ON THE WEST COAST FROM CAPE TOWN TO DEKAR AND TWO WEEKS AGO WE FORFEITED OUR DEPOSIT. SO I WAS GOING TO WAIT FOR THIS PRESENTATION, BUT--[LAUGHTER] ANYWAY, WITH US TODAY IS DR. RICHARD DAVEY WHO IS THE DEPUTY DIRECTOR OF THE NATIONAL ALLERGY AND INSTITUTE OF INFECTIOUS DISEASES. DR. RICHARD DAVEY, SO THANK YOU FOR BEING HERE. >> THANK YOU. I PUT A PACKAGE TOGETHER OF THE VARIOUS FEATURES BUT I CAN CONCENTRATE MORE ON ONE THAN THE OTHER IF THERE'S A PARTICULAR INTEREST. I WANT TO GIVE YOU A WHIRL WIND TOUR OF WHAT'S GOING ON WITH EBOLA THIS PAST YEAR AND COVERS A LOT OF DIFFERENT TOPICS BUT LAT ME MARCH THROUGH IT AND SEE WHAT YOU LIKE. I SHOULD ACKNOWLEDGE HEAVILY ABOUT THEY BORROWED OR STOLE FROM DR. FAUCI'S TALK, A PERFECT STORM, AND THE TALK FROM LAST WEEK. TO BEGIN WITH, THE BASIC VIROLOGY, THOSE ARE NOT FAMILIAR WITH IT IT'S THE FIBROLA VIRUS FAMILY AND IT'S PART OF THE MARVA AND EBOLA VIRUS. THE VIRUS ITSELF, FIVE SPECIES OF WHICH FOUR CAUSE DISEASE IN PEOPLE. THE ONE THAT DOESN'T IS RESTIN, ALTHOUGH THERE WAS CONCERN ORIGINALLY THAT IT COULD BE PATHOGENIC AND HASN'T BEEN SHOWN TO BE, THE ONE WE'RE MOST CONCERNED ABOUT IS THE ONE--THE ZAIRE SPECIES THAT'S ACCOUNTING FOR THE DEVASTATION IN WEST AFRICA. THIS IS A SCANNING E. M. OF THE EBOLA VIRUS AND I WOULD CHARACTERIZE IT AS HAUNTINGLY BEAUTIFUL AND TRULY DEADLY, IT'S ANOTHER VIEW OF A SAME VIRUS. THE EBOLA VIRUS IS A TYPICAL SINGLE STRANDED, NEGATIVE STRANDED RNA VIRUS, IT CONSISTS OF EIGHT RNA GENE SEGMENTS SEVEN OF WHICH ARE STRUCTURAL AND ONE WHICH IS NONSTRUBLGTURAL AND VARIETY IS DIAGNOSTIC TECHNOLOGY VS BEEN DEVELOPED PRIMARILY PC R TO LOOK FOR THE PRESENCE OF THE VIRUS AND MOSTLY CONTRAITING ON THE GLYCOPROTEIN OR THE NUCLEAR PROTEINS AS WELL AS MATRIX PROTEIN. AND WE KNOW A FAIR AMOUNT OF THIS VIRUS, NOT JUST FROM THE CURRENT EPIDEMIC BUT ALSO HAVE MANY, MANY YEARS OF STUDY IN VARIOUS GIFTS FOR THE LABORATORIES, AND EBOLA VIRUS IS NOT COMPLETELY UNDERSTAND--IT'S MOST LIKELY TO RESIDE IN THE FRUIT BAT AND THERE'S PROBABLY TRANSMISSION IN NONHUMAN PRIMATES IN THE WILD AND OF COURSE, WITH THE COMSUMPTION EVERSUFPLGSZ OF BUSH MEAT THAT MATE BE COUNTING FOR THE TRANSMISSION CYCLE WHETHER IT'S COMSUMPTION OF THE FRUIT BAT ITSELF WHETHER IT'S A DELICACY OR NONHUMAN PRIMATES, BOTH OCCUR IN THE EFFECTED AREA AND MAY BE RESPONSIBLE FOR THE OUTBREAKS. THE TAUPISM OF EBOLA VIRUS IS ALSO A SIGNIFICANT ERA OF A RESEARCH INTEREST. IT HAS A PREDOMINANTLYLICATION FOR CERTAIN CELL TYPES BUT IT'S FAIRLY UCIBOLITTOUS IN TERMS OF WHAT IT'S ABLE TO INFECT. PRIMARILY OR INITIALLY IF IT INFECTS MONOCYTE MACROPHAGES PARTICULARLY DENDRITIC CELLS, BUT LATER IN THE THE COURSE OF THE DISEASE, IT CAN EFFECT EAL CELLS, VARIOUS ORGANS IN THE BODY INCLUDING LIVER AND BRAIN AND REGARDLESS OF WHERE IT INFECTS IT GENERALLY CAUSES CYTOKINE RELEASE AND A CELL APOPTOTIC RESPONSE AND IT CAUSES IN PARTICULAR, AN ENDO THELIA DYSFUNCTION THAT CAN BE QUITE PROFOUND IN INFECTED PATIENTS RESULT NOTHING SIGNIFICANT VOLUME LOSS AND VASCULAR LEAKAGE AND SPACING OF FLUID IN THE INFECTED INDIVIDUAL. EVEN THOUGH IT'S CONSIDERED A HEMORRHAGIC FEVER VIRUS, IT'S FAIRLY UNCOMMON WITH THE DISEASE ITSELF. THIS IS THE PARTICULAR COURSE OF EBOLA VIRUS. THERE'S BEEN CONCERN THAT PERHAPS THE CURRENT OUTBREAK WASN'T MIRRORING THIS TYPE OF CLINICAL COURSE BUT MORE AND MORE IT IS. IT'S HAPPENING BECAUSE OF SHEER VOLUME OF THE NUMBER OF CASES WE'RE JUST APPRECIATING MORE AND MORE DIFFERENT MANIFESTATIONS CLINICALLY, THAT'S HOW THE VIRUS CAN PRESENT. THE INCUBATION PERIOD IS TYPICALLY EIGHT TO 10 DAYS ALTHOUGH IT CAN RANGE UP TO 21 DAYS. THERE'S EVEN CONCERN THAT THIS 21 MAY BE AN UNDERESTIMATE BUT MOST PEOPLE STILL BELIEVE 21 DAYS IS THE OUTER LIMIT OF WHEN THE INCUBATION PERIOD CAN OCCUR AND THIS IN TURN EFFECTS HOW LONG WE KEEP PEOPLE UNDER OBSERVATION WHEN THEY HAVE AN EXPOSE TOWER EBOLA VIRUS, THE FIRST FEW DAYS OF CLINICAL ILLNESSER CHARACTERIZED BY FLU LIKE ILLNESS AND IT CAN MIMIC INFLUENZA OR VIRAL INFECTION, WEAKNESS, FEVER, GENERAL SYSTEMIC COMPLAINTS AND THE GI SYMPTOMS IN DAYS FOUR-SEVEN AND THEN THE THEN THE NEXT DAYS ACCOUNT FOR VOLUME LESS AND TREATMENT AT A CENTER, AND IF PROGRESSIVE, DAY SEVEN-10 YOU SEE CONFUSION, SOME BLEEDING TYPICALLY FROM THE MUCUS MEMBRANE OR OTHER AREAS, BUT AGAIN THAT'S NOT TYPICALLY A MAJOR COMPLICATION OF THE ILLNESS IF THE VOLUME LOSS PROCEEDS AND IT'S UNTREATED THEN SHOCK RESULTS. AT THAT POINT DEPENDING ON THE VIRAL LOAD AT THE TIME THE PATIENTS, THE HOSTS INNATE DEFENSES, THE OUTCOME IS EITHER RECOVERY OR DEATH AND AS YOU KNOW IN MOST CASES, UNTREATED IT'S DEATH. >> IN THE NEXT FEW SLIDES I WILL SHOW YOU THE DEMOGRAPHICS OF THE INFECTION OVER THE LAST SEVERAL MONTHS. BUT OVEROT RIGHT HAND SIDE OF THE SLIDE YOU CAN SEE THE MOST EFFECTED COUNTRIES, GUINEA, SIERRA LEON AND LIBERIA. THIS WAS MAY, IT WAS APPRECIATED IN HIGHER NUMBERS IN MAY. AND AGAIN HERE'S GUINEA AND HERE'S SERRA LIAISON LEON AND HERE'S LIBERIA AND THEN JULY, AND THEN THE NUMBERS ARE STARTING TO INCREASE. HERE'S SEPTEMBER, ALMOST ALL THE COUNTIES IN SIGNIFYERA LEON, AND HERE'S OCTOBER, IT'S IN THE THOUSANDS. ESSENTIALLY ALL OF WEST AFRICA EXCEPT FOR CERTAIN PARTS OF GUINEA WERE CONSUMED WITH THE INFECTION AND LOOK AT THE NUMBERS OF REPORTED CASES AND THESE ARE THE ONES THAT CAME TO MEDICAL ATTENTION, OBVIOUSLY THESE ARE POSSIBLY AN UNDERESTIMATE OF THE ACTUAL NUMBER OF CASES. AND HERE'S NOVEMBER. LIBERIA WAS TOPPING THE LIST AT THIS POINT WITH OVER 7000 CASES. SIERRA LEON NOT FAR BEHIND AND THEN THIS MONTH, DECEMBER WHERE UNFORTUNATELY HAD SURGED PASSED LIBERIA AND IF YOU ADD IT UP, THIS WEEKEND IT'S EXCEEDED 18,000 WITH OVER ONE-THIRD OF THOSE BEING FATAL CASES. SO THIS IS BASICALLY WHAT'S HAPPENED THIS PAST MONTH. THE EPIDEMIC CONTINUES IN LIBERIA BUT IT'S DYING DOWN TO SOME DEGREE, UNFORTUNATELY IT'S RISING IN SIERRA LEON. THIS IS WHAT DR. FAUCI SHOWS, IT'S PUTTING TOGETHER THE MAJOR PRIOR OUTBREAKS OF EBOLA VIRUS I AFRICA, AND SHOWN WITH THE RED DOTS ARE THE NUMBER OF EFFECTED PATIENTS. THE CURRENT OUTBREAK IS SHOWN HERE AND JUST BY SHEER SIZE COMPARISON, YOU CAN SEE HOW DRAMATICALLY DIFFERENT THIS CURRENT OUTBREAK IS IN TWEBT 14. IT TRUMPS ALL THE OTHER OUTBREAKS COMBINEDDED BY SEVERAL FOLD. THERE'S--THE REIS THERE WAS ALSO A SMALL OUTBREAK IN THE DRC ALSO THAT'S CONTROLLED AND IT'S A SEPARATE OUTBREAK THAN THE ONE THAT'S HAPPENED IN WEST AFRICA. THERE'S SOME CONCERN ABOUT THE CURRENT OUTBREAK, WHERE DID IT INFECT SO MANY PEOPLE IN CONTRAST OF PRIOR OUTBREAK, MANY REASONS FOR THAT, THE DEMOGRAPHICS, FACT THAT IT'S RURAL AS WELL AS URBAN OUTBREAK. THERE WAS SOME CONCERN THAT PERHAPS THE VIRUS MUTATED AND INDEED ONE CAN TRACK AT LEAST OR A APRIL A HUNDRED DIFFERENT GENOME SEQUENCES BETWEEN THE CURRENT STRAIN OF EBOLA VIRUS VERSES THE PREVIOUS STRAINS, BUT TODAY THERE'S NO EVIDENCE THAT ANY OF THESE GENE SEQUENCES WHICH MAY JUST REPRESENT ANGIOGENIC DRIFT ACCOUNTED FOR FUNCTIONAL CHANGE IN THE VIRUS. SO AS FAR AS WE KNOW, IT'S TILL BEHAVING THE WAY PRIOR EBOLA VIRUS HAS BEHAVED. THE U.S. RESPONSE, I THINK IT'S BEEN DRAMATIC. THE STATEMENT THE PRESIDENT MADE IN SEPTEMBER LOOKING FOR AGAIN ESTABLISHING THAT THE U.S. WOULD TAKE A LEADERSHIP ROLE IN THIS OUTBREAK, MADE A SIMILAR STATEMENT TWO WEEKS AGO WHEN HE VISITED NIH. THEY COMMITTED OVER 3000 TROOPS, COMMITTED TO THE CONSTRUCTION OF 17 DIFFERENT EBOLA TREATMENT UNITS, HUNDRED BED UNITS TO BE BUILT IN THE EFFECTIVE AREAS. THIS INCLUDES A 25 BED FACILITY FOR HEALTHCARE WORKERS THAT WAS BUILT IN THE MMU OR MOBILE MEDICAL UNIT THAT WAS BUILT IN MONRO SPECIFICALLY STAFFED BY PUBLIC HEALTH OFFICERS. THAT UNIT HAS SEEN IN EXCESS OF 10-15 PATIENTS ALREADY AND WE'RE WORKING CLOSELY WITH CDC AND USA ID, TO TREAT IN MULTIPLE DIFFERENT WAYS. WHAT ABOUT THE U.S.? JUST BEING A LITTLE PAROCH FOR A MOMENT. SO TO DATE THERE HAVE BEEN SIX PATIENTS OR HEALTHCARE WORKERS PRIMARILY WHO HAVE BEEN MEDICALLY EVACUATED TO THE U.S. FROM WEST AFRICA. THERE ALSO HAVE BEEN TWO CASES THAT WERE IMPORTED INADVERTENTLY INTO THE U.S., ONE THE FAMOUS CASE OF UNFORT FATALLY MR. DUNCAN IN DALLAS WHO WAS DIAGNOSED AT DALLAS PRESBYTERIAN AND THEN THE HEALTH CARE WORKER RETURNING FROM HIS DUTY IN WEST AFRICA WHO WAS DIAGNOSED IN NEW YORK CITY AND WAS HOSPITALIZED AT BELL VIEW WHERE HE RECOVERED FORTUNATELY. THERE HAVE BEEN TWO CASES OF TRANSMISSION OF THE VIRUS IN THE U.S., BOTH NURSES, BOTH IN DALLAS, SECONDARY TRANSMISSION FROM THIS ONE CASE IN DALLAS. WE HAD THE PRIVILEGE OF CARING FOR ONE OF THESE NURSES HERE AT THE CLINICAL CENTER AND THEN THERE HAVE BEEN THREE HEALTHCARE WORKER WHO IS HAVE BEEN MEDICALLY EVACUATED AFTER SUSTAINING A HIGH RISK EXPOSURE TO THE VIRUS. TYPICALLY IT'S EITHER A NEEDLE TICK OR PENETRATION OF THE GLOVES OR A SIMILAR TYPE OF EVENT. THE TREATMENT OF THOSE THREE INDIVIDUALS IS LISTED HERE, ONE RECEIVED A SMALL RNA COCKTAIL CALLED TKMARKED FOR IDENTIFICATION EBOLA, SHE GOT FIVE OUT OF SEVEN INTENDED DOSES AND THEN TWO OTHER INDIVIDUALS WHO RECEIVED THE RVSV EBOLA VACCINE AS PREVENTATIVE. WE IN FACT HAVE HOSPITALIZED RIGHT NOW THE THIRD OF THESE INDIVIDUALS IN SPECIAL CLINICAL STUDIES UNIT HERE AT NIH. WE'RE NOT ALONE IN THIS EFFORT. OTHER NATION VS HAD THEIR MEDICAL EVACUATIONS PERFORM OFFICE OF DIVERSITY THEIR HEALTH CARE WORKERS AND THESE ARE COUNTRIES THAT HAD HEALTHCARE WORKERS BROUGHT BACK TO THEIR COUNTRIES FOR ADVANCED CARE. WE HAVE REGULAR CALL EVERY WEDNESDAY MORNING TO DISCUSS THE MANAGEMENT OF THESE INDIVIDUALS AND HEALTH CARRY NOTES SO WE'RE ALL BENEFITS FROM EACH OTHER'S EXPERIMENT IN THE MANAGEMENT OF INDIVIDUALS AND IT'S BEEN A USEFUL CONVERSATION TO HAVE. CDC ORGANIZED THOSE CALLS. WE HAVE OUR OWN SPECIAL CLINICAL STUDIES UNIT HERE AT THE NIH, AT THE HIGH CONTAINMENT ISOLATION UNIT AND WE DESIGNED ORIGINALLY TO SERVE AS THE PLACE TO HOSPITALIZE THE LABORATORY WORKERS FROM ANY OF THE BSL-FOUR LABORATORIES AT FORT DIETRICK, BUT IT'S BEEN USED FOR MEDICALLY EVACUATED EBOLA PATIENTS. YOU MAY RECOGNIZE THAT INDIVIDUAL IN THERE THE PPE, HE'S ONE OF THE LOWER PAID NIAID WORKERS. SIMULTANEOUS THERE'S BEEN BIGGER EFFORTS WITH THE PORT, PORT OF EXIT, LEAVING THE AREA AND ALSO THE PORT OF ENTRY INTO THE U.S., LOOKING FOR CERTAIN, YOU KNOW CARDINAL SYMPTOMS THAT MAY BE SUGGESTIVE OF EBOLA INFECTION AND OF COURSE, UPON SCREENING SIMILAR TYPES OF SCREENS BASED ON MEDICAL HISTORY EXPOSURE RISKS, CLINICAL SYMPTOMS, ET CETERA. WE HERE AT THE NIH IS ONE OF THE CENTERS IF SUCH A PATIENT WERE TO BE SEEN AT DULLES AND SCREENED IN FOR A LIKELIHOOD OF INFECTION, WE WOULD BE ASKED TO HOSPITALIZE THAT INDIVIDUAL HERE. FORTUNATELY THE STATISTICS DON'T BEAR OUT A SIGNIFICANT RISK, IF YOU LOOK AT DATA FROM AUGUST TO SEPTEMBER, THERE WERE OVER 36,000 PEOPLE SCREENED, 77 OF WHICH WERE DENIED BOARD OF OF VARIOUS SYMPTOMS OR STRONGLY SUGGESTED HISTORY SUCH AS FRESH CONTACT WITH AN EBOLA PATIENT AND ZERO OF THOSE ZERO WERE DIAGNOSED WITH EBOLA. MOST COMMON CONFUSION HAS BEEN WITH MALARIA AND MOST RECENTLY WITH INFLUENZA AND AS WE HAD INTO THE FLU SEASON THAT,'S GOING TO BE A BIG CONCERN THAT THERE ARE A LOATHE OF PATIENTS WHO ARE PRESENTING WITH FLU WHO ARE NOT ACINATED FOR EXAMPLE. AND OUR RETURNING HEALTHCARE WORKERS ARE COMING BACK WITH THE FLU SEASON THAT'S STARTING CURRENT LEAP SO AS THEY ENTER THEIR 21 DAY FEVER WATCH WE'LL HAVE TO BE CONCERNED ABOUT THEM DEVELOPING AN ILLNESS THAT CAN BE CONFUSED WITH EBOLA. THE CDC REVISED ITS GUIDELINE FOR HOW YOU CHARACTERIZE TRAVELERS OR OTHER INDIVIDUALS OR HEALTHCARE WORKERS FOR EXAMPLE IN TERMS OF THEIR RISK LEVEL FROM HIGH RISK AND DIRECT CKET WITH EBOLA IN AN EFFECTED PATIENT WITHOUT APPROPRIATE PPE AND PERSONAL PROTECTIVE EQUIPMENT AND SOME RISK THAT IS IF YOU HAD BEEN EXPOSED BUT WERE WEARING APPROPRIATE PPE AT THE TIME AND TO LOW RISK AND HAD SUGGESTIVE TRAVEL HISTORY AND BRIEF CONTACT TAKEN--THEY IN A WAY THAT SHOULD NOT HAVE ALLOWED TRANSMISSION OF VIRUS AND THEN NO RISK AND THEN IT'S PARTICULARLY IMPORTNT FOR AND THAT'S IMPORTANT FOR PEOPLE WHO ARE WORKING THIS AREA AND EFFECTS HOW WE SCREEN INDIVIDUALS AND IN TURN EITHER SUGGEST THEY'VE BEEN IN ISOLATION OR QUARANTINE OR WHAT CATEGORY THEY'RE IN AND HIGH RISK HAVING HEAVILY RESTRITIONS ON THEIR ACTIVITIES WERE FORTUNATELY MOST HEALTH CARE WORKERS ARE FALLING INTO THE SOME OR LOW RISK EVALUATED INDIVIDUALLY. SO THE STATE HEALTH DEPARTMENTS NOT CDC, USE THESE DETERMINATIONS AS TO THE CRITERIA TO BE APPLIED FOR QUARANTINE OR ISOLATION. AND WE TURN ON TO RESEARH AND DEVELOPMENT THERE ARE TWO CURRENT VACCINES THAT ARE PROBABLY AT THE FOREFRONT OF THE EFFORT, THERE ARE OTHERS IN THE PIPELINE BUT USE OF THE TWO THAT ARE MOST ADVANCED NIAID HAS WORK WIDE GLAXOSMITHKLINE TO DEVELOP ONE OF THE VACCINES THAT YOU MAY HAVE HEARD ABOUT. IT'S THE CHAMP ADENO THREE VACCINE IT'S A GLYCOPROTEIN COMPETENT VACCINE. PHASE 21 TRIALS WERE COMPLETED TWO MONTHS AGO BY THE VACCINE RESEARCH CENTER IN 20--20 INDIVIDUALS AT TWO DIFFERENT DOSES. AS I SAID IT'S A REPLICATION WHICH HAS PROVEN TO BE A REASONABLY GOOD VECTOR FOR GETTING THE VIRUS INTO THE BODY AND RESULTS IN GLYCOPROTEIN EXPRESSION AND FAIRLY ROBUST IMMUNE RISPONSE BOTH AT THE HUMOR ALL AND CELL MEDIATED LEVEL. THE DATA SUPPORTING THE VACCINE WERE FAIRLY STRONG. AGAIN A CHIMP ADENO VECTOR AND NONHUMAN PRIMATE STUDIES IN THE HUMAN TRIAL SHOWED A HUNDRED% PROTECTION AT FIVE WEEKS THAT IS CHALLENGING THE ANIMALS AT FIVE WEEKS AFTER VACCINATION RESULT INDEED A HUNDRED% PROTECTION, 10 MONTHS LATER THE PROTECTION SEEMED TO WANE TO 50% SO THAT RAISES THE ISSUE ABOUT THE DURABILITY OF THE RESPONSE AND THAT REMAINS TO BE DETERMINED AT END CLINICAL TRIALS. AS WE SAID IT WAS DEVELOPED BY THE NIH IN COLLABORATION WITH GLAXOSMITHKLINE. THE TRIAL WAS USING THE BI-VALENT FORM, IT HAS ACTIVITY AGAINST BOTH THE ZAIRE AND SUDAN TRAINS OF EBOLA, SIMULTANEOUSLY THERE'S A PHASE ONE TRIAL AGAINST THE PERFORMITANCE THAT BEGAN IN OXFORD AND CURRENTLY MANUFACTURED FOR LARGE SCALE EVALUATION. THIS THE REPORT THAT JULIA LEDGER HAD IN THE NEW ENGLAND JOINERRAL A FEW WEEKS AGO, SHOWING THE RESULTS OF THAT PROMISING PHASE ONE STUDY. THEY'VE STUDIED TWO DIFFERENT DOSES, TWO TIMES 10 TO THE 10th AND TWO TIMES 10 TO THE 11th AND IT WAS WELL TOLERATED AND THEY HAD FAIRLY GOOD ANTIBODY AND HUMORAL CELL MEDIATED RESPONSES. THE SAFETY DATA FROM THAT STUDY WERE PROMISING, BOTH DOSE HIS FAIRLY MINIMAL SIDE EFFECTS, NOTHING BEYOND THE PANEL I WOULD I, I WON'T GO THROUGH THE INDIVIDUAL SIDE EFFECTS BUT THERE WERE SOME DIFFERENCES WITH THE TWOIDACY DOSES WITH THE HIGHER DOSE CAUSING THE SIDE EFFECTS BUT AGAIN OVERALL TOLERATED. THESE ARE THE ANTIBODY TITERS THAT WERE SEEN ON THE LEFT-HAND SIDE, LOOKING AT THE--AGAIN IT'S A BI VALENT SO LOOKING AT ZAIRE, VERSES YOU DAN ACTIVITY,--SUDAN ACTIVITY, YOU CAN SEA TWO WEEKS INTO THE VACCINE, THERE'S A SUBSTANTIAL BOOST IN THE TITERS, LOOKING AT THE HIGHER DOSE OF THE VACCINE TWO TIMES 10 TO THE 11th, THERE WAS A MORE ROBUST RESPONSE. SO SIMILAR LEVELS WERE SEEN WITH THE SUDAN ACTIVITY AND PRIMARY INTEREST CURRENTLY IS WITH THE ACTIVITY AGAINST THE TRAIN. THERE ARE ADDITIONAL STUDIES ONGOING WITH THAT PARTICULAR VACCINE, IN PARTICULAR, IN THE STUDY GOING ON IN MALI, THAT'S LOOKING AT A DOSE LIKE WE BELIEVE THE MANUFACTURE INTENDS TO VILE AND WE'LL SEE WHAT THE RESULTS OF THAT ARE. AND THE OTHER ACSEEN OF PROMULGATEINENCE IS THE VSC OR THE DERMATITIS ON THE VACCINE, THAT'S A REPLICATION COMPETENT VACCINE, PHASE ONE TRIAL, THEY'RE UNDERWAY AND FULLY ENROLLED, BSC IS A VECTOR, IT'S A LOW LEVEL PATHOGEN FOUND IN ANIMALS, COWS, HORSES, ET CETERA DOESN'T CAUSE MUCH PROBLEM IN PEOPLE. IT F IT DOES IT USUALLY LEAVES ORAL LESIONS THAT RESOLVE IN A FEW DAYS BUT IT'S PROVEN TO BE A GOOD VECTOR FOR CARRYING THE EBOLA GLYCOPROTEIN GENE. AGAIN IT'S REPLICATION COMPETENT, RESULTS IN GLYCOPROTEIN EXPRESSING AT A DESCENT IMMUNE RESPONSE. IT WAS DEVELOPED IN ASSOCIATION WITH NEW LINKED GENETICS AND NOW TAKEN OVER BY AMERICA AND THE PROMULGATEITING THING ABOUT IT IS SIM LA TO THE OTHER VACCINE, IT SHOWS PROTECTIOT PRIMATES, IT'S FIVE WEEKS, PHASE ONE STUDIES WERE UNDERTAKEN HERE AND WALTER REED ARMY AND RESEARCH IN OCTOBER, AND STUDIES ARE NOW FULLY ENROLLED AND THE ONLY DIFFERENCE BETWEEN WALTER REED IS A SINGLE INJECTION AND OUR STUDY IS A PRIME BOOST. WE STUDIED THREE DIFFERENT DOSE LEVELS AT THREE TIMES 10 TO THE SIXTH ALL THE WAY UP TO ONE TIMES 10 TO THE EIGHTH. AND AGAIN THEY'RE FULLY ENROLLED AND COLLECTING IMMUNO GENERATEDISSITY DATA AND SAFETY DAT O THE STUDIES. THERE ARE OTHER STUDIES GOING ON ELSEWHERE, WITH THE DIFFERENT MEASUREMENTS, THERE ARE SOME SIDE EFFECTS FROM THE VSV PART, CAUSING LO GRADE FEVERS AND LOW GREAT ARTHRALGIA. OVERALL PRETTY WELL TOLERATED. OURISTS IN WEST AFRICK ASO THIS SUMMARIZES COMMUNICATIONS BETWEEN THEIR COUNTRY AND BASICALLY HHS, TO CONDUCT RESEARCH ON PROMISG THERAPEUTICS TO WHICH THE SECRETARY RESPONDED OF COURSE, WE WOULD BE HAPPY TO ACCEPT YOUR INVITATION AND THAT LED TO--THAT OVERTRAO*U TOUR LED TO A VARIETY OF CONVERSATIONS AND MEETING ON HOW HHS IN PARTICULAR COULD WORK WITH THE MINISTRY OF HEALTH IN LIBERIA TO FACILITATE STUDYING SOME OF THE AGENTS THAT ARE AVAILABLE, VACCINES. AND AS A RESULT OF THAT WE ARE PLANNING TO DO AN AMBITIOUS PHASE TWO-THREE STUDY OF VACCINES LOOKING AT TWOT VACCINES, I MENTIONED THE VSV AND THE CHIMP ADENO THREE, VERSES A PLACEBO, AND CONTROL FORMAT, 27,000 PATIENT STUDY AND DONE IN LIBERIA AND POSSIBLY IN THE OTHER COUNTRY FIST THE ARRANGEMENTS CAN BE MADE, THAT WOULD BE LOOKING AT THE EFFICACY OF THOSE VACCINES IN DIMINISHING THE TRANSMISSION RATE OF EBOLA IN THE EFFECTIVE POPULATION. [INDISCERNIBLE] IS OVER THERE RIGHT NOW CONTINUING NEGOTIATIONS WITH THE LIBERIA AND HOW THE STUDY COULD BE IMPLEMENTED AND THEN THERE'S TING CLINICAL INFRASTRUCTURE. THE ASSUMPTIONS OF THE STUDY AND THE EBOLA DISEASE AND POPULATION AT 1 PERCENT AND THE CAVEAT IS WE DON'T FEBRUARY THE 1 PERCENT INS--DON'T KNOW IF THE ONE% WILL SHIFT FROM LIBERIA TO SIERRA LE LEON, BUT IT IS WHAT IT IS FOR NOW. THERE'S NO QUESTION THAT THERE ARE A DIFFERENCE OF VARIETIAL INVESTIGATIONS RIGHT NOW, BUT THE SINGLE MOST IMPORTANT THING YOU CAN DO IS FLUID RESUSCITATION. PATIENTS TYPICALLY PREVENT IN ONE OR TWO CATEGORIES HYPER PWOLEMIC NOT IN SHOCK, CAN YOU TRY ORAL MEDICS, ORAL REHYDRATION, ELECTROLYTE REPLACEMENT OR IF THEY'RE IN SHOCK, YOU HAVE TO MOVE TO ADDRESSIVE IV FLUID RESUSCITATION AND THIS MODALITY HAS BEEN NOT TOO EFFECTIVE IN THIS CAPACITY TO PROVIDE. THIS NONETHELESS, THERE IS INTEREST IN LOOKING AT THE ACTIVITY OF VARIOUS FUGITIVE ANTIVIRAL OR ANTIVIRAL AGENTS OF POTENTIAL UTILITY IN TREATING EBOLA VIRUS AND VARIETY OF POINTS OF THE VIRAL LIFE CYCLE ONE COULD ATTACK FROM ANTIBODY USES OF ANTIBODIES TO ANTIMOLECULES TO MUCOSA AND AN LOGS. PLASMA OR CONVALESCENT PLASMA HAS HAD A CHECKERED HISTORY IN VIRAL DISEASES BUT IT'S ALSO BEEN TOUTED AS POTENTIALLY THE UTILITY IN TREATING EBOLA VIRUS. YOU AWE KNOW IT'S BEEN USEFUL IN ANTHRAX AND PARO VIRUS B-19 AND USE INDEED FOR EXAMPLE, INFLUENZA CASES AND INCLUSIVE EVIDENCE WITHOUT ACTIVITY AND USE INDEED EBOLA, AS WELL, START NOTHING THE 1995 OUTBREAK, THERE WERE EIGHT PATIENTS WHO GOT CONVALESCENT PLASMA FOR RECOVERY PATIENTS, SEVEN OF WHOM SURVIVED AND THIS WAS NOT A CONTROLLED EXPERIENCE BUT NONE THE LESS IT WAS A FAVORABLE OUTCOME WITH A LOW MORTALITY COMPARED TO WHAT YOU CONSIDERED UNTREAT, CONTROLLED AT THE TIME. THERE ARE ALSO OTHER STUDIES THAT HAVE BEEN MADE. THERE'S A CONCENTRATED FORM OF THE PLASMA MAY BE BETTER THAN JUST CONVALESCENT ALONE BUT THAT IS NOT PROVEN. THESE ARE LOOKING AT ANTIBODY TITERS IN THE RECIPIENTINGS OF PLASMA FROM THAT 1995 OUTBREAK AND YOU CAN SEE, THAT THEY DO GET A VERY RST TITER INCREASE WITH THE PLASMA. IGM, AND PRIMARILY IGGTHAT'S SUSTAINED. THIS TO SUMMARIZE WHAT HAPPENED TO PATIENT WHO IS HAVE BEEN BROUGHT TO THE U.S. IN TERMS OF THEIR OUTCOMES WE HAVE AN ADVANCED LEVEL OF CARE HERE IN THE U.S. OF COURSE, SO OUR CASE FATALITY RATE HAS BEEN LOWER, APPROXIMATELY 20% NOW, COMPARED TO CASE FATALITY RATES IN WEST AFRICA THAT ARE AS HIGH AS 70-80% IN MOST--IN SOME CENTERS PROBABLY AVERAGES 40-50% ACROSS THE BOARD AND WITH CENTERS THAT ARE ABLE TO ORDER OR AFFORD AGGRESSIVE ID FLUID RECESSITATION, MAYBE 20 OR 30%. I SHOW THIS, THIS IS WHAT'S BEEN USED IN THE RETURNING HEALTHCARE WORKERS AND I SHOW THIS PRIMEAR ILLEGALS TOW SHOW THAT A VARIETY OF DIFFERENT MODALITIES OF TREATMENT HA BEEN USED BUT IT'S ALL OVER THE MAP. THERE ARE PROBABLY OF THE 10 OR SO PATIENTS SEVEN HAVE RECEIVED EXPERIMENTAL FORM OF THERAPY OVER ANOTHER, SOME HAVE RECEIVED MULTIPLE FORMS OF THERAPY, AND THE NURSE WE HAD THE PRIVILEGE OF CARING FOR, AND THEY HAVE RECEIVED FOUR DIFFERENT EXPERIMENTAL INVESTIGATIONALS, AND YOU TRY TO MAKE SENSE OF THAT AS TO WHAT PROVIDED BENEFIT THIS IS IN FACT THAT NURSES CASE THE PC R RESULT OF THE I HAVE ROLL LOAD ANYTHING DOWN AND THESE ARE THE MODALITIES SHE RECEIVED, TITER AND ZMAPPS WHICH ARE TRIPLE MONOCLONAL COCKTAIL SHE GOT THESE IN DALLAS BEFORE SHE CAME TO US AND WE WERE THEN ASKED, WELL WHAT RESULTED IN THIS NICE DROP IN HER VIRAL LOAD AND ALL WE CAN DO IS THROW UP YOUR HANDS AND SAY, GOD, WE DON'T KNOW. IT'S REALLY IMPOSSIBLE TO SAY. SO THE BOTTOM LINE IS IT'S IMPOSSIBLE TO DRAW INFERENCES OR CLINICAL BEN FRIT FROM THE WAY THEY'VE BEEN STUDIED TO DATE, WHETHER IN THE U.S. OR WESTERN EUROPE, WHEREVER THEY'VE BEEN GIVEN, THEY'VE BEEN GIVEN ALL DIFFERENT LEVELS OF DISEASE SEVERITY WITH DIFFERENT VIRAL LOAD, STARTED AT DIFFERENT TIMES IN THE CLINICAL COURSES OF THE PATIENTS AND IN--AS I MENTIONED IN SEVERAL CASES, MULTIPLE INTERVENTIONS HAVE BEEN GIVEN ONE ON TOP OF EACH OTHER IN WHICH IT'S ALMOST IMPOSSIBLE TO TELL WHAT DID OR DID NOTES PROVIDE BENEFIT OR EVEN WHAT MIGHT PROVIDE CAUSE HARM. THAT'S THE OTHER PART OF THE SITUATION. WE REAL DOE DON'T KNOW WHETHER THESE PATIENTS WOULD HAVE NEEDED THESE OR THESE INTERVENTIONS DELAYED HEALING, IMPOSSIBLE TO SAY. THEY WERE ALL GIVEN UNCONTROLLED FORMAT. THIS IS A LIST OF FIVE OF THE ONES THAT HAVE BEEN COMMONLY USED AS THE SIX, THAT CAN BE ADDED TO THIS, WHICH IS ANOTHER RNA INTERFERING MOLECULE FROM [INDISCERNIBLE] BUTLET MOST TOPICAL ONES TO MENTION QUICKLY IS THE MONOCLONAL COCKTAIL AND FAVIPIRAVIR, WHICH IS AN RFA POLYMERASE INHIBITOR, WE HAVE TRIPLE MONOCLONAL COCKTAIL, IT'S CURRENTLY NOT IN SUPPLY, THE MANUFACTURE IS HOPING TO HAVE A LOT PRODUCED, AVAILABLE IN JANUARY. BUT IT'S ONE THAT'S BEEN GIVEN TO SEVERAL DIFFERENT HEALTHCARE WORKERS RETURNING TO THE U.S. IN WHICH IN THE MEETING WITH ORIGINAL COLLEAGUES AND INVESTIGATORS AT THE HIGH CONTAINMENT UNITS IT WAS THE ONE MOST DESIROUS TO GIVE TO PATIENTS IN EXPERIMENTAL TRIAL. THE DATA SUPPORTING IT ARE FAIRLY GOOD IN PARTICULAR IT WAS ABLE TO RESCUE A HUNDRED PERCENT OF MONKEYS UP TO FIVE DAYS AFTER THEY WERE--AFTER THEY WERE INFECT WIDE EBOLA VIRUS, NONE OF THE OTHER EXPERIMENTALS HAVE THIS DURABILITY THAT IS THE GAM BETWEEN WHEN THE INFECTIOUS CHALLENGE OCCURRED AND WHEN THEY WERE ABLE TO BE RESCUED WITH THE APPLICATION OF EXPERIMENTAL AGENT. THIS IS JUST LOOKING AT THOSE DATA COMPREHENSIVELY AGAIN. WHEN YOU INFECTED THESE PRIMATES WITH THE LETHAL DOSE OF EBOLA AND THEN WAITED FIVE DAYS AND STARTED GIVING THE ZMAPP PRODUCT YOU WERE ABLE TO RESCUE ALL OF THEM WHICH IS REMARKABLE. THE OTHER ONE I MENTIONED PREVENTIVELY IS FAVIPS IRAVIR, IT'S AN HRA POLYMERASE INHIBITOR, IT'S BROAD SPECTRUM, RUNS A DIFFERENT OF RNA AND DNA VIRUSS WHICH MAKE ITSERALITIER UNUSUAL AND IT ALSO HAS FAVORABLE SUPPORTIVE NONHUMAN PRIMATE DATA AND ALSO SMALLER ANIMAL MODEL DATA IN MOUSE MODELS FOR EXAMPLE WHERE IT'S BEEN ABLE TO RESCUE A HUNDRED% OF MICE A CHALLENGE. ALL OF THAT IS A PLUG FOR WHY WE CAN'T CONTINUE TO GIVE THESE ANTIVIRAL THIS IS WAY HOWEVER, BECAUSE IN FAIRNESS NOT ONLY IN INDIVIDUALS GIVING THE THERAPIES NOW TO FAIRNESS IN FUTURE OUTBREAKS WE NEED TO KNOW WHETHER THESE ARE ANTIVIRALS ARE CAUSING BENEFIT, HARM OR DOING NOTHING WHATSOEVER AND THE ONLY WAY TO DO THAT IS TO PUT THEM INTO A RANDOMIZED CLINICAL TRIAL TO STUDY THEM AND IN FACT, THE NIADD, IS DEVELOPING A TRIAL THAT WE'RE HOPING TO INVESTIGATE SOON IN WEST AFRICA WHEN WE IDENTIFY WEST AFRICAN SITES THAT MIGHT BE CAPABLE OF CONDUCTING RESEARCH ON TOP OF THE HEAVY BURDEN OF CLINICAL CARE AND THE ADAPTABLE TRIAL AND COMPARE WISE TO OPTIMIZE STANDARD OF CARE AND SUPPRESSIVE FLUID SUPPORT, ALL THE THINGS YOU WANT TO DO ANYWAY, FOR AN EBOLA PATIENT AND COMPARE THAT TO AN INVESTIGATOR DRUG ADD TO THE AGGRESSIVE SUPPORT AND THE TRIAL IS WRITTEN IN SUCH A WAY THAT WE CAN SWITCH TO DIFFERENT INVESTIGATIONALS IF YOU HAPPEN TO RUN OUT OF A PARTICULAR ONE, LIMITED SUPPLY, AND IMPLEMENT THAT STUDY IN JANUARY, HERE AT NIH AND THE OTHER UNIT AND WHEN THEY'RE READY IN WEST AFRICA. AND THIS TYPE OF DATA DEVELOPED AGAIN SO WE CAN MAKE HEADS OR TAILS AS TO WHETHER THESE DRUGS ARE IN FACT PROVIDING BENEFIT OR NOT. SO IN SUMMARY, MY TIME IS OVER. THERE'S A ROBUST RESEARCH EFFORT GOING ON, U.S. GOVERNMENTS RECORDING THAT. THERE ARE SOME COUNTERMEASURES ARE BEING STUDIED THAT LOOK PROMISING BUT WE NEED DEFINITIVE TESTING. AND THERE ARE ALSO THE NEED TO DO VACCINE STUDIES FOR EFFICACY IN THE EFFECTED AREAS OF THE COUNTRY. THAT'S ALSO IN DEVELOPMENT AND HOPEFULLY TO BE IMP LEMED FAIRLY QUICKLY. THECHALLENGE WE HAVE IT'S FINE TO DO THESE STUDIES IN THE U.S. BUT IN THE EFFECTED AREAS WE NEED A CLINICAL TRIAL INFRASTRUCTURE TO EXIST IN ORDER TO SUPPORTS SUCH STUDIES AND WE THINK IN LIBERIA THAT WILL BE POSSIBLE, AND HOPEFULLY IN OTHER AREAS THEY REMAIN ACTIVE TOPICS OF DISCUSSION. WHY DON'T I STOP THERE. >> THANK YOU VERY MUCH AND THEY THINKS TO YOUR COLLEAGUES FOR WHAT YOU ARE DOING, VERY IMPORTANT OBVIOUSLY, WE CAN TAKE ONE OR TWO MINUTES FOR QUESTIONS, I SUSPECT THERE ARE SOME. >> FLANSY WHY DON'T YOU START OUT. >> YES I'M CURIOUS WHETHER THERE'S ANY INFORMATION COMING FROM PATIENT WHO IS WERE EXPOSED BUT DID NOT GET INFECTED ANYTHING ABOUT WHAT THE SENSE IS LIKE? >> SO PEOPLE HAVE DONE SEROSER VEYS WHERE PEOPLE HAVE ANTIEBOLA ACTIVITY, PICKED UP IGGSMAZE IN PARTICULAR BUT NO ONE KNOWS THE CLINICAL CORRELATE OF THOSE CASES, DO THEY HAVE CLINICAL INFECTION, JUST FOR WHATEVER REASON NOT BROUGHT TO MEDICAL ATTENTION. WE KNOW WHAT SEEMS TO WORK IN THE VACCINES WHICH SEEMS TO BE A WAY OF LOOKING AT THAT ISSUE, ONE OF THE VACCINES TO BE--THAT IS THE CHIMP ADENO THREE VACCINE LOOKS LIKE IT'S INDUCING CELL MEDIATED AND ANTIBODY RESPONSE, AND NANCY SULLIVAN WOULD SAY THAT SHE FEELS THE CELL MEDIATED RESPONSE IS MOST IMPORTANT. ONLET OTHER HAND THE VSV RACK SEEN INDUCES A VERY ROBUST IGG RESPONSE. IT DOESN'T EVEN, YOU DON'T NEED NEUTRALIZING ACTIVITY WITH THAT AND THE CELL MEDIATED ACTIVITY LOOKS SOMEWHAT MORE DESPERATE SO IT'S POSSIBLE THE VACCINES ARE WORKING BY DIFFERENT MECHANISMS SO THE SHORT ANSWER IS NO ONE IS QUITE SURE. IF WE HAVE AT LEAST TWO PARADIGMS THAT SUGGEST SOMEWHAT DIFFERENT MECHANISMS BUT BOTH OF WHICH HAVE BEEN PROTECTIVE IN NONHUMAN PRIMATE MODELS. THANK YOU VERY MUCH AND YOU HAVE SLIDES PRESENTED TO THE ACD, JUST ON THURSDAY. SO IT WAS GOOD TO SEE THEM. OT QUESTION I HAD IS, AND I MAY HAVE MISS TODAY IF YOU SAID IT BUT I KNOW THAT A ANOTHER PATIENT WAS ADMITTED TO THE CLINICAL CENTER LAST FRIDAY AND I WAS WONDER FIGURE THAT PERSON HAS EBOLA OR NOT OR WE DON'T KNOW YET. >> WE DON'T TALK ABOUT INDIVIDUAL PATIENTS IN GROUP SETTINGS. THAT PERSON IS SOMEONE WHO WAS EXPOSED TO EBOLA AND I WILL LOAMACY EVALUATION PROCESS IT AT THAT. >> OKAY. >> RICK, YOU GOT TO THE ENDEMIC REGION, DO YOU KNOW HOW SEROLOGICALLY, HOW MANY PEOPLE HAVE A PREVIOUS RESPONSE TO THE ADENO THREE? >> THAT'S THE CONCERN THAT MAYBE THERE'S A HIGHER INCIDENCE IN THAT POPULATION VERSES OTHER POPULATIONS, I DON'T HAVE CURRENT DATA ON THAT, SCOTT, TO KNOW WHAT THE SEROPREVALENCE WOULD BE IN THAT SITUATION. >> IT'S STRIKING THAT ON THE MAPOT EPIDEMIOGY THAT THE IVORY COAST AND LIKE NOTHING, QUESTION IS, IS IT NOTHING OR LEAKING OVER OR IS THERE REALEE GOOD PROTECTION THAT COULD PRESREBT THE MIGRATION-- >> LET BORDERS OF THOSE THREE COUNTRIES AND YOU PROBABLY SEEN THE PICTURES ARE MAYBE A RIVER OR A FOREST IN BETWEEN BUT THERE'S A LOT OF MOVEMENT BACK AND FORTH, THAT UNREGULATED, I BELIEVE IVORY COAST IMPLEMENTED BORDER CONTROL WHETHER THAT'S RESPONSIBLE FOR THE LACK OF SPREAD, I CAN'T SAY, BUT I KNOW THEY DID MAKE THOSE CHANGES, YEAH. THERE ARE FEW OTHER EFFECTED AREAS AND HAD AN ACTUAL PATIENT TRAVEL THERE WHO CAUSED A SMALL INCIDENT THERE AND THEN IT WAS A CHILD WHO BROUGHT THE SECTION TO MALI, BOTH OF THOSE HAVE BEEN CONTROLLED, FORTUNATELY. AND AS I MENTIONED THE OUTBREAK IN THE DCR WAS UNRELATED TO THIS ONE. >> THERE ARE ANY QUESTIONS FOR THOSE OF YOU ON THE TELEPHONE? >> NEUROECTODERMAL IS VERY HELPFUL THANK YOU. >> THANK YOU; I WILL SAY WE HAD A WONDERFUL SESSION HERE IN ANN ARBOR YESTERDAY UNDER SOMETHING CALLED THE [INDISCERNIBLE] SOCIETY FOR THE DOCTORS IN THE COMMUNITY. SO IT WAS A STATE HEALTH OFFICIAL RESPONSIBLE FOR PREPAREDNESS IT WAS A PREVALENT VIRAL EPIDEMIOLOGY AND THINK OF THE NEW YORK TIMES THERE'S BEEN COVERING THIS STORY AND IT'S JUST BACK FROM WEEKS, SEVERAL WEEKS IN WEST AFRICA. SO THERE'S YOU KNOW OBVIOUSLY INTENSE INTEREST ALL AROUND THE COUNTRY. >> WELL, AGAIN THANK YOU SO MUCH. >> NOT ONLY FOR WHAT YOU'RE DOING BUT FOR TAKING THE TIME TO SHARE WITH IT WITH, I AM TOLD WE HAVE NO OTHER--NO MEMBER OF THE PUBLIC TO SIGN UP TO MAKE REMARKS WE WILL CHECK ONCE AGAIN AT THE APPROPRIATE TIME BUT BECAUSE OF THAT, I THINK IF WE COME BACK AT 1:20, THAT SHOULD WORK ALL RIGHT. AND TO THOSE WHO DON'T KNOW WHERE THE CAFETERIA IS, WE WILL HAVE GUIDES AT THE DOOR TO HELP YOU FIND IT THE ANALOGY, SOME OF YOU HAVE HEARD IT BEFORE, I KNOW THEY WANT US TO GO FASTER, BUT TO SOME EXTENT, THE WAGON A COUPLE OF LOOSE WHEELS. I'M SURE WE COULD MAKE IT GO FASTER BUT THAT SEEMS TO ME TO BE AT TIMES DANGEROUS, BECAUSE THE WHEELS MIGHT FALL OFF. SO I GUESS I'M GOING TO BE ON R HERE AS SAYING I KNOW WE'RE SUPPOSED TO FIGURE OUT WAYS TO MAKE IT GO FASTER. BUT I THINK WE OUGHT TO FIGURE OUT WAYS TO MAKE IT BE BETTER AND BETTER MIGHT -- WE MIGHT APPROACH FASTER BUT WE MAY HAVE A SEGUE BEFORE WE GET THIS THIS. SO WITH THAT SAID, RICHARD? >> WAYS TO HAVE SOME KIND OF PRESCREEN WOULD BE A GOOD THING FROM OUR PERSPECTIVE. HOWEVER, WE'VE BEEN TOLD A NUMBER OF DIFFERENT WAYS THAT IDEAS THAT WE'VE HAD IN THE PAST HAVE NOT PASSED LEGAL MUSTER. SO FIGURING OUT A WAY OF DOING IT WITHIN OUR AUTHORIZATION OR, IF NECESSARY, CHANGING OUR AUTHORIZATION WOULD BE REQUIRED, AND I ALSO KNOW GOING AND ASKING FOR A CHANGE IN AUTHORIZATION IS OPENING A DOOR WHICH NIH HAS HAD SOME BAD EXPERIENCES WITH IN THE PAST. SO LET ME JUST SAY THAT THE IDEA OF REDUCING THE WORKLOAD OF REVIEWERS BY HAVING A PRESCREENING PROCESS HAS BEEN DISCUSSED INTERNALLY. I MAY BE POSSIBLE TO WORK OUT A WAY TO FIGURE OUT HOW TO MAKE IT A LEGAL PROCESS, I THINK DELLA HAS IDEAS ABOUT THAT, SO WE'D BE WILLING FOR IT TO BE DISCUSSED. WE HAVE IN SOME OF OUR EDITORIAL PROCESSES A FORM OF PRESCREEN USING MALE REVIEWERS, SO WE THINK THIS IS DISCUSSING IN MORE DEPTH. DELLA, DO YOU ANYTHING YO HAVE ANYTHING YO U WANT TO SAY? >> YOU MENTIONED THIS TOO, WHICH OF THE VERY MANY GOALS ARE WE TRYING TO ADDRESS BY DOING THAT. SO IF ONE SET OF GOALS IS TO REDUCE THE BURDEN ON PEER REVIEW STAFF, THAT'S A GOOD GOAL, I'M NOT SAYING IT'S NOT, BUT IS THAT THE GOAL OR IS THE GOAL TO HELP PROVIDE BETTER FEEDBACK SO THAT PEOPLE KNOW THE IDEA -- AREN'T GOING TO WORK SO THEY DON'T HAVE TO DO FULL APPLICATION, SO SORT OF REDUCING THEIR BURDEN SO THAT THEY'RE NOT SPENDING TIME WRITING THESE LONG APPLICATIONS FOR SOMETHING THAT MAY NOT BE VERY -- WE HAVE TO BE MINDFUL WHICH OF THE GOALS WE'RE TRYING TO HAVE PRIMARY, AND IF WE CAN, SET UP SOME OF THESE EXPERIMENTS TO ALSO LOOK AT THE COLLATERAL PIECES OF IT AS WELL. SO IF THE PRIMARY GOAL IS TO HELP PEOPLE REALIZE THIS IDEA PROBABLY ISN'T GOING TO FLOAT, DON'T SPEND YOUR TIME WRITING AN APPLICATION, WE COULD POTENTIALLY DEVELOP A PROCESS FOR DOING SO BUT IT MAY NOT ALLEVIATALEVE REVIEW. BECAUSE I DON'T THINK AT THE END OF THE DAY WE CAN TELL PEOPLE TO JUST GO AWAY. I THINK WE CAN TELL PEOPLE TO DISCOURAGE THEM, BUT WE CAN'T SAY FLAT OUT DON'T COME BACK. >> WHILE THE GOAL MAY BE ONE PARTICULAR OBJECTIVE, WE MAY ACTUALLY ULTIMATELY SOLVE MANY DIFFERENT PROBLEMS OR DEFICIENCIES WITHIN THE SYSTEM WHICH ACTUALLY IS ULTIMATELY BETTER FOR THE SYSTEM, BUT A QUALITY OF MORE INNOVATIVE GRANTS, LESS BURDEN ON THE INDIVIDUAL APPLICANT WHO'S PUTTING THAT PROCESS TOGETHER. WITH REGARD IT TO YOUR COMMENT ABOUT NOT -- PEER REVIEW, THERE'S NO REASON WHY THIS CAN'T BE A PEER REVIEWED ENTITY. SO WHAT WAS BROUGHT UP IS, ONE SOLUTION WOULD BE POSSIBLY AN EDITORIAL BOARD REVIEW, ONE THING AS I WAS COMMENTING THIS MORNING AS A TRIAL BALLOON WAS DO YOU HAVE SORT OF TWINNING OF SECTION REVIEWS, WHICH IS YOU HAVE THE FIRST SECTION REVIEWED AS A PRE-PROPOSAL, IT GETS BACK -- IMMEDIATE FEEDBACK TO THE INDIVIDUALS TO SAY WE ENCOURAGE YOU TO GO AHEAD FOR A FULL GRANT, AND AT THE SAME TIME WHATEVER TIMING OF THAT REVIEW POD IS, IT GOES TO A SECOND GROUP THAT THEN REVIEWS THE FULL APPLICATION. SO THERE'S A CONSTANT CHURNING OF THAT PROCESS SO THAT THERE'S NO HUGE ADDED TIME BECAUSE YOU'RE WAITING FOR THE NEXT APPLICATION PERIOD TO GO FROM PRE-REVIEW TO A FULL REVIEW PROCESS. SO FROM A LEGAL STANDPOINT, OBVIOUSLY YOU HAVE TO ADDRESS THAT, BUT AS LONG AS YOU'RE GETTING A PRE-REVIEW BY A PEER GROUP, IT'S GOING TO A FULL REVIEW BY A PEER GROUP AND THE FACT IS, THE APPLICANT WHO GETS A NEGATIVE FEEDBACK CAN STILL PUT IN THE PROCESS, THAT, I THINK IS ULTIMATELY -- WORKS OUT BETTER FOR THE SYSTEM. >> ALL THE DETAILS WOULD MAKE A LOT OF DIFFERCE, SO AS I HEARD ONE SUGGESTION THAT MAYBE PROGRAM STAFF COULD DO THE PRE-REVIEW CSR REVIEW, STAFF WOULD DO THE SECOND REVIEW, THEN PROGRAM STAFF WOULD GET IT AGAIN. I DON'T THINK THAT THAT'S A PRACTICAL APPROACH, SO I THINK THAT -- OH, OKAY. ALL RIGHT. >> SENIOR PEOPLE THAT HAVE DRIFTED FROM THE RESPONSIBILITY OF REVIEWING, I THINK THERE'S A LOT OF POTENTIAL THERE. SCOTT? >> SO SWITCH FROM THE PRE-REVIEW COMMENTS, I WAS ACTUALLY UNDER THE -- MAYBE IT WAS THE WRONG ILLUSION, THAT THE WHOLE PROCESS WAS TOTALLY BROKEN, PARTICULARLY REGARD WITH THE FUNDING ELEMENT IN THE SEPTEMBER COUNCIL MEETING, AND I MEAN, I HAVE TO SAY, I WAS SURPRISINGLY ENCOURAGED BY THE IC FROM NEUROLOGY THIS MORNING THAT THIS ARE -- AND WITH DR. BRIGGS' COMMENT THAT NOT ALL INSTITUTIONS HAVE THE SAME COMPOSITION OF GRANT PROCESS, I THINK THAT BETTER PROCESSES CAN BE IP PLEMENTED TO MAKE THIS WORK BETTER ACROSS THE NIH. MAYBE YOU WOULD WANT TO COMMENT ON THAT, ARE THEY DOING SOMETHING -- YOU POINTED OUT SOME OF THE THINGS THAT THEY'RE DOING WHICH MAY BE NOT UNIFORMLY ADOPTED BY OTHER INSTITUTES THAT MAY BE FROM A POSITIVE STANDPOINT MAY RESPOND TO THE LACK OF CONGRESSIONAL TIMELINESS WITH REGARD TO THE BUDGET PROCESS. >> I THINK THERE'S NO QUESTION THAT 24 INSTITUTES AND CENTERS THAT ARE FUNDING OFFER DIFFERENT EXPERIMENTS IN DIFFERENT WAYS OF APPROACHING MANY OF THESE IDEAS, AND TRUE THE EPMC GROUP THAT DELLA AND SALLY RUN, IT IS A GOOD POINT OF COMPARISON AMONG THE DIFFERENT INSTITUTES TO TRY AND FIGURE OUT WHAT ARE THE BEST PRACTICES THAT SHOULD BE IMPLEMENTED. ANOTHER WAY IN WHICH THEY VARY A LOT IS DIFFERENT INSTITUTES HAVE VERY DIFFERENT PRACTICES IN TERMS OF SPEED IN WHICH THEY DO THEIR INTERNAL REVIEWS, SO COMPARISON WITHIN INSTITUTES, SO THERE ARE PLACES WHERE THAT'S DONE AND THE INSTITUTES NEED TO DECIDE WHAT THEY WANT TO DO. SO CSR IS NOT THE ONLY POINT OF COMPARISON. >> CAN I EXPAND A LITTLE ON WHAT RICHARD IS SAYING. AS ALLEN MENTIONED EARLIER, ONE -- ANOTHER AREA OF VARIATION IS THE EXTENT TO WHICH ICs LOOK AT PROGRAMMATIC BALANCE, TRACK RECORD OF INVESTIGATORS IN RECRUDING AND OTHER THINGS IN A SORT OF GRAY ZONE AROUND THE PAYLINE. AS THE HEAD OF A VERY SMALL CENTER, VERY EXTENSIVELY I USE MY ADVISORY COUNCIL FOR THOSE DELIBERATIONS. THIS EXPEDITED CONCURRENCE OR MORE RAPID REVIEW ISN'T COMPASSABLE WITH THAT KIND OF INVOLVEMENT AT THE ADVISORY COUNCIL. LARGER ICs DO NOT INVOLVE THEIR ADVISORY COUNCILS IN THOSE DISCRETIONARY JUDGMENTS TO THE SAME DEGREE. SO THAT IS ONE OF THE IMPORTANT AREAS THAT -- AND THERE ARE PORTFOLIO REASONS, I HEAD A CENTER WITH A VERY BROAD MANDATE AND WITH SOMETIMES CONTROVERSIAL THERAPIES THAT REALLY DO NEED TWO LEVELS OF PEER REVIEW. >> WE PUT THE SLIDE BACK UP THAT'S NOW BEHIND BOTH OF YOU, WHAT WE TITLED MAJOR CHANGES UNDER CONSIDERATION, JUST HELP US -- REMIND US AND MAYBE HELP FOCUS THE TIME WE HAVE HERE. I WANT TO START -- I WOULD LIKE TO GO BACK AND I WANT TO ACTUALLY DISCUSS AND HEAR FROM YOU ABOUT TWO OF THEM SPECIFICALLY. FIRST THE MIDDLE ONE. WHICH IS THE SPENDING AUTHORITY BEING EXTENDED BEYOND ONE YEAR. THERE'S A LOT OF STRONG SUPPORT FROM THAT, FOR THAT IN THE WORKING GROUP. WE'VE HEARD -- YOU CAN ALWAYS THINK OF A REASON NOT TO DO SOMETHING. WE'VE HEARD A LITTLE BIT ABOUT THAT. BUT ARE THERE ANY ADDITIONAL THOUGHTS OTHER THAN WHERE WE STAND WITH IT NOW, WHICH IS THAT WE THINK THAT THAT WOULD BE A BIG HELP WITHIN THE INSTITUTE. ARE THERE ANY -- RICHARD? >> I THINK THIS COULD BE VERY HELPFUL IN MAKING SURE THAT THERE ARE NO DEAD FUNDING ZONES WITHIN THE YEAR. HOWEVER, IF IT'S USED JUST AS AN EXCUSE TO DELAY AWARD OF APPLICATIONS UNTIL THE LAST TIME YOU HAVE THE OPTION TO MAKE AWARDS, THEN THAT WOULD BE A VERY BAD THING. SO AS LONG AS THERE WAS A SYSTEMATIC COMMITMENT TO SPEND A PORTION OF THE BUDGET AT REGULAR INTERVALS, THAT'S OUR PERSPECTIVE, AND DELLA? >> I WOULD AGREE COMPLETELY. THE SPENDING BEHAVIOR MODIFICATION WOULD HAVE TO COME ALONG WITH THAT AS WELL, SORT OF A COMMITMENT ESSENTIALLY ON OUR PART TO BE TIMELY AND NOT TO DO, AS RICHARD POINTED OUT, ENDING UP WITH THE SAME PROCESS, BUT INSTEAD OF A TWO YEAR PERIOD, A ONE YEAR PERIOD. I THINK THAT WOULD TAKE SOME RESPONSIBILITY ON OUR PART. BUT IT COULD BE VERY USEFUL. WE'VE WORKED WITH SOME OTHER AGENCIES WHERE THEY'VE HAD MORE FLEXIBILITY, AND IT'S BEEN VERY INTERESTING WORKING WITH THEM AND SEEING HOW THEY THINK ABOUT THEIR BUDGET AND THE WAY THEY THINK ABOUT SPENDING THEIR MONEY AND HOW THEY THINK ABOUT IT. SO I THINK IT WOULD BE A VERY BIG CHANGE FOR US. >> THE IDEA OF ONLY SPENDING PART OF YOUR BUDGET BECAUSE YOU DON'T REALLY KNOW WHAT YOUR FULL BUDGET IS, AND THEN HAVING TO HAVE YOUR STAFF REDO THE BUDGETS OF ALL THE GRANTS THAT YOU'VE AWARDED, THAT'S A REAL WASTE OF TIME. >> SO IF I COULD FIRST UNDERSCORE, FIRST OF ALL ASKING FOR THE AUTHORITY, PUTTING IT IT ON FRANCIS' PLATE, ASKING FOR THE AUTHORITY, BUT I WOULD UNDERSCORE THE POINT THAT DELLA MADE, AND THAT IS WE HAS AN NIH HAVE BEEN CHALLENGED ON MANY OCCASIONS FOR WHY WE SPEND OUR MONEY IN THE SECOND HALF OF THE YEAR, WHEREAS MOST OF THE OTHER AGENCIES, WHICH ARE NOT GRANTING AGENCIES, SPEND THEIR MONEY THROUGHOUT THE YEAR BECAUSE IT'S PERSONNEL. OURS IS A DIFFERENT STORY. I THINK KATHY COULD PROBABLY TELL YOU WHAT THE STATE OF AFFAIRS IS NOW, BUT FOR A FEW YEARS, WE WERE BEING ASKED WHY DON'T YOU NEED THIS MONEY AT THE BEGINNING OF THE YEAR, RIGHT? DELLDELLA WOULD HAVE THAT HISTORY. >> I'M SITTING HERE ALSO THINKING TOO IN TERMS OF THE PROCESS THAT WE GO THROUGH, WHICH EVERY IC GOES THROUGH, AND GRIFF AND ALL OF YOU CAN SPEAK TO THIS ABOUT YOUR PLANNING FOR SOME OF YOUR LARGER INITIATIVES. AND I THINK THERE IS A STRATEGIC POINT BECAUSE OF OUR BUDGET ISSUES THAT VERY FREQUENTLY THE APPLICATION RECEIPT AND THE DECISION FOR THOSE LARGER TICKET ITEMS ARE MORE IN THE SUMMER TOWARDS THE END ESSENTIALLY, MOVING INTO THE END OF THE FISCAL YEAR, SO THAT WE HAVE THE MONEY, SO YOU KNOW HOW MUCH MONEY YOU HAVE AND CAN DEVOTE TO THESE LARGER ITEMS. SO IF WE HAD TWO-YEAR AUTHORITY, THAT WOULD POTENTIALLY FREE THAT UP A BIT MORE. FOR THE PARTS THAT ARE ACTIVELY PLANNED IN TERMS OF THE -- OF THE RFAs PRIMARILY, BEING ABLE TO PLAN THOSE OUT POTENTIALLY LITTLE BIT MORE EVENLY AND NOT NECESSARILY HAVE THEM BUNCHED INTO THAT ONE SORT OF QUADRANT WHERE MOST OF THE ACTION IS NOW. >> IF THERE WAS A TWO-YEAR AUTHORITY, WHAT HAPPENS, IS IT THE END OF THE SECOND YEAR THEN WORSE THAN -- >> NO, ROLL. >> IT'S ROLLING? SO IN FACT YOU'D AVOID THAT? >> I MUST SAY THIS YEAR IS THE EARLIEST THAT I CAN REMEMBER HAVING A BUDGET. I MEAN, AM I RIGHT? KATHY? IT'S BEEN A LONG TIME. >> I WAS A YOUNG WHIPPER SNAPPER. >> I THINK THE REASON BEHIND THAT WAS EVEN THOUGH WE DIDN'T GET THIS LAST BUDGET UNTIL JUST THIS WEEKEND, WE AT LEAST KNOW THAT THE TOP NUMBER WAS FOR '14 AND '15, SO AS A WORST SCENARIO, WE KNEW WHERE WE STOOD. >> WE TALKED ABOUT THE LENGTH OF TIME PARTICULARLY WHAT IT MEANS TO REVIEWERRING, TIME THAT OCCUPIES RESEARCHERS AND SO ON, ONE OF THE THINGS I HOPE WE'LL EMPHASIZE IN THE REPORT IS THE OPPORTUNITY COSTS HERE. SCIENCE IS SO FAST MOVING, SOMEBODY HAS A BRILLIANT IDEA THAT TAKES A YEAR TO GET STARTED OR SIX MONTHS, I THINK I'VE TOLD THE STORY HERE BEFORE, NOT FROM BIOMEDICAL FIELDS OR THE FIELDS I'M FAMILIAR WITH, BUT FRIEND OF MINE WHO RAN INTEL TOLD ME THAT THE REVENUES INTEL RECEIVES ON THE LAST CALENDAR DAY OF THE YEAR, NINE IT TI% OF THEM COME FROM A PRODUCT THAT DIDN'T EXIST ON THE FIRST DAY OF THAT SAME YEAR. IF THAT'S THE BASE PASTE AT WHICH SCIENCE AND TECHNOLOGY ARE MOVING, TO HAVE A YEAR LAG, INTEL WOULD BE OUT OF BUSINESS IN ONE YEAR. >> AND IN ADDITION TO THAT, WHILE THAT RESEARCH GROUP IS WAITING TO START THE PROJECT, DO THEY LET PEOPLE GO BECAUSE THERE'S NO FUNDING, DO THEY SHUT DOWN A LAB AND RE-OPEN IT WHEN THE GRANT FINALLY COMES THROUGH, DOES THE INSTITUTION PICK UP THE COST, WHICH IS OFTEN WHAT HAPPENS, BUT THE CAPACITY FOR THE INSTITUTIONS TO DO THAT IS QUITE LIMITED. >> CAN I JUST ASK ON THAT SAME POINT, NANCY AND OTHERS WHO RUN INSTITUTIONS, LARRY, HOW OFTEN ARE YOU ALL CALLED UPON TO PROVIDE THIS 90-DAY ADVANCED FUNDING? I JUST DON'T HAVE A SENSE OF WHETHER IT'S 5% OF THE APPLICANTS WHO KNOW THAT THEY'RE WITHIN THE PAY LINE, WHO IT'S GOING TO TAKE SOME TIME TO GET THE MONEY OUT BUT THERE IS THIS 90 DAY PRE-AWARD AUTHORITY THAT MANY INSTITUTIONS DO, AND I DON'T KNOW WHAT THE RESILIENCE IS, I DON'T HAVE A SENSE OF HOW OFTEN THAT'S USED. >> I DON'T SIGN OFF ON THOSE SO I'M NOT SURE, BUT WHAT WE HAVE HAD I WOULD SAY MAYBE 10 TIMES OVER THE LAST YEAR ARE PEOPLE WHO ARE TOLD THEY'RE PROBABLY GOING TO GET THEIR GRANTS BUT THEY DON'T REALLY KNOW WHEN IT'S GOING TO COME THROUGH, AND SO THEY COME TO THE INSTITUTION AND SAY LOOKS LIKE I MIGHT GET IT A YEAR FROM NOW BUT I'M GOING TO HAVE TO LET GO OF MY MOST PRODUCTIVE PEOPLE IF I HAVE TO WAIT FOR A YEAR TO GET THE FUNDING, CAN YOU HELP, AND WE'VE STEPPED IN AND HELPED WITH THOSE THOSE. >> PRE-AWARD AUTHORITY IS JUST CASH FLOW, AND THAT'S -- FOR A BIG INSTITUTION, MANAGEABLE. I'S THE TRUE UNCERTAINTY. I MEAN, YOU KNOW, THAT'S THE ONE THAT CAN -- >> FROM THE INSTITUTIONAL PERSPECTIVE, WHAT WE WOULD REFER TO AS BRIDGE FUNDING, SO THAT YOU DON'T LET GO OF YOUR MOST PRODUCTIVE PEOPLE FOR A PERSON THAT YOU'RE BETTING ON THAT -- THIS IS MAYBE SOMEBODY WHO'S JUST OUTSIDE THE PAY LINE. AND THEY KNOW THEY'RE NOT GOING TO BE FUNDED. THE REAL PRESSURE THAT -- THE DIMINISHING OVERALL FUNDS AT ANYHAS PUT SEVERE PRESSURE ON THE INSTITUTIONS BECAUSE YOU HAVE TO MAINTAIN A CERTAIN CRITICAL EFFORT IN YOUR LAB. YOU CAN'T JUST LET PEOPLE GO, THEN THE GRANT COMES, OKAY, NOW I CAN HIRE PEOPLE AND GET STARTED AGAIN. YOU ALL KNOW IT DOESN'T WORK THAT WAY. >> THAT'S NOT WHAT I WAS ACTUALLY ASKING FOR THESE PEOPLE WHO ARE IN THE FOURTH PERCENTILE, WHERE AN INSTITUTE IS ALWAYS PAID THAT. BUT THEY'RE NOT GOING TO -- THE DECISION IS NOT BEING MADE YET. BRIDGE FUNDING IS VIEWED REALLY QUITE DIFFERENT. >> I WAS COMING BACK TO NORM'S POINT ABOUT THE FACT THAT IT CAN TAKE A YEAR, YOU COULD BE JUST OUTSIDE THE PAY LINE AFTER THAT YEAR AND YOU HAVE TO MAINTAIN A CRITICAL MASS IN YOUR LAB, THAT FALLS TO THE INSTITUTION. I AGREE WITH LARRY, THE OTHER PART IS EASY, THAT'S JUST CASH FLOW AND NOT A BIG ISSUE. >> LISTEN TO THIS DISCUSSION HAS BEEN VERY INFORMATIVE. THINKING ABOUT MORE LONG TERM SOLUTIONS, IT SEEMS TO ME THAT THE CURRENT SITUATION IS THE WAY IT'S GOING TO BE FOR A WHILE. IT'S NOT GOING TO BE BACK TO THE DOUBLING OF THE NIH BUDGET ANY TIME SOON, SO MY IMPRESSION IS THAT A LOT OF FUNDAMENTAL THINGS HAVE TO CHANGE ABOUT HOW RESEARCH IS FUNDED IN THIS COUNTRY. SO ONE IDEA THAT I HAD HAD THAT I DON'T KNOW HOW TO COME TO FRUITION WOULD BE TO HAVE SOME KIND OF INSTITUTIONAL FEDERAL BRIDGE FUNDING PROGRAM, ALMOST LIKE A T32 FOR FACULTY OR PROGRAMS, WHERE THE INSTITUTE PROVIDES SOME AMOUNT IN THEIR BRIDGE FUNDING AND THEN THERE'S A T32 COMPONENT THAT THE INSTITUTE CAN APPLY TO THE NIH TO PROVIDE SOME CONTINUITY TO THE INVESTIGATOR AT THEIR INSTITUTION, SO AT TIMES WHEN THEY CAN'T GET THEIR OWN RO1 RENEWED OR GET THEIR FIRST RO1, THERE'S SOME BASE FUNDING FOR THE INSTITUTION, SOME SMALL AMOUNT THAT ALLOWS EACH P.I. TO HAVE ONE SENIOR SANE TIS. I BELIEVSCIENTIST. I BELIEVE THIS IS HOW MANY INSTITUTIONS IN EUROPE ARE FUNCTIONING AND HAVE BEEN FOR QUITE SOME TIME. SO THAT'S COMPLETELY DIFFERENT AND WOULD REQUIRE COOPERATION ON THE PART OF THE INSTITUTES AS WELL ON THE -- I MEAN THE ACADEMIC INSTITUTES AND PART OF THE FEDERAL GOVERNMENT. BUT OTHERWISE THERE'S SO MUCH INEFFICIENCY WHEN I SEE A SENIOR FACULTY MEMO BR HAVING TO FIRE EVERYBODY IN THEIR LAB BECAUSE THEY CAN'T GET THEIR RO1 RENEWED OR THEY JUST CAN'T GET A PROJECT OFF THE GROUND, AND IT'S SO INEFFICIENT, IT'S JUST SO INEFFICIENT. WE ARE LOSING SO MUCH IN TERMS OF PRODUCTIVITY AND THEN HAVING TO SPEND ALL THIS TIME ON WRITING NEW GRANT PROPOSALS. SO I DO THINK I WOULD TRY TO ENCOURAGE THE COMPLETELY SORT OF DIFFERENT MECHANISMS OF HOW TO FUND RESEARCH IN THIS COUNTRY AS A WHOLE. >> IF YOU WANT TO COMMENT ON THAT, THAT WOULD SMACK IN SOME PLACES AS WELFARE FOR SCIENCE, AND I GUESS ONE OF THE THINGS I'M SORT OF APPALLED ABOUT RIGHT NOW IS THAT WE SEEM TO BE RESIGNED TO MEDIOCRITY OF AMERICAN SCIENCE, THAT WE'RE ACCEPTING THAT WE WILL GENTLY SLIDE BACKWARDS ON THE PROPORTION OF MONEY SPENT ON SCIENCE COMPARED TO TB GDP JUST WHEN OTHER COUNTRIES ARE CRANKING UP THEIR SPENDING. SAYING EXACTLY THAT WE SAW HOW THE U.S. DID IT FROM WORLD WAR II UNTIL NOW, NOW THAT THE U.S. IS TAKING A BREAK FROM FUNDING SCIENCE, WE HAVE OUR CHANCE. THAT SEEMS TO BE -- WE SEEM TO BE RESIGNED TO FINDING A MECHANISM TO SURVIVING THIS, AS OPPOSED TO SAYING THAT IF UNITED STATES WANTS TO HAVE A SCIENCE AND TECHNOLOGY FUTURE, WE HAVE TO GET BACK ON THE BALL. >> THAT'S A GREAT ADVERTISEMENT FOR THE REPORT THAT NORM AND YOLANE CO-CHAIRED. >> I'M NOT SURE IT'S LEGAL TO QUOTE ME ON THAT. >> I DON'T THINK YOU HAVE ANY DISAGREEMENT FROM ANYBODY AROUND THE TABLE. >> I THINK IN ALL FAIRNESS, FRANCES COLLINS HAS MADE THAT POINT OVER AND OAF AGAIN BEYOND -- PROBABLY BEYOND THE BOUNDARIES OF WHAT HE SHOULD BE SAYING IN TERMS OF THE DEPARTMENT. BUT HE IS UNREMITTING, UNREMITTING. >> WE MAKE THE POINT TIME AND TIME AGAIN, IT'S NOT JUST EUROPE, IT'S CHINA, IN TERMS OF PERCENTAGE OF THEIR FIVE-YEAR PLAN THAT GOES TO SUPPORTING SCIENCE, BIOTECH INDUSTRIES. IT'S ONE OF THEIR MAIN THRUSTS OF DEVELOPMENT. COULD I SWITCH TOPICS A LITTLE BIT? ACTUALLY I'D LIKE TO ASK RICHARD TO COMMENT, WHICH IS THE WHOLE QUESTION OF REDUCING THE CYCLES FROM THREE TO TWO. IF, IN FACT, BY A PRESCREENING PROCESS YOU REDUCE THE NUMBER OF APPLICATIONS DOWN BY A THIRD OR 40%, WASN'T A -- IT WASN'T ANTICIPATED BY NSF, THAT THEY REDUCED IT BY A HALF WHEN THEY WENT THROUGH THE CONTINUOUS SUBMISSION PROCESS. BUT IF YOU WERE ABLE TO DO THAT AND ACHIEVE IT, WOULD A TWO-CYCLE PROCESS WORK FOR YOU? >> CERTAINLY WE COULD DO REVIEW THAT WAY, BUT I'D JUST LIKE TO SAY THAT IT WOULD BEING EXTREMELY COMPLICATED. THERE ARE A NUMBER OF DIFFERENT FEATURES WHICH WOULD CHANGE. SO OBVIOUSLY FOR ANY GIVEN NUMBER OF APPLICATIONS DONE THEE TIMES A YEAR, IT WOULD RAISE THE NUMBER TO 50% FOR THE TWO TIMES A YEAR. IT WOULD -- WE WOULD HAVE THESE BULGES GOING THROUGH FOR MANY PURPOSES UNLESS WE HAD A COMPLEX REDID DISTRIBUTION OREDISTRIBUTION ACROSS COMMITTEES AND PERHAPS MOVED OR BROADENED WHERE WE DID REVIEWS. THAT WOULD BE COMPLICATED P IT WE ONLIF WEONLY HAD TWO COUNCIL MEETINGS PER YEAR, BECAUSE EVERYONE WANTS TO BE AS CLOSE TO POSSIBLE AS COUNCIL SO THEY HAVE THE MAXIMUM AMOUNT OF TIME TO WRITE GRANTS AND DO OTHER THINGS, AS OPPOSED TO WAITING UNTIL THE NEXT COUNCIL TIME CAME UP. SO UNLESS YOU FIGURE OUT A WAY OF SPREADING OUT THE COUNCIL DECISIONS AND EVERYTHING ELSE ALONG THE WAY, IT WOULD RESULT IN, I THINK, TOO LONG A DEAD TIME OR TOO BIG A PEAK OF ACTIVITY. >> SO JUST TO RESPOND, I DON'T THINK THERE WAS ANY PLAN TO REDUCE THE NUMBER OF COUNCILS. IT WAS TO MAINTAIN THOSE THREE COUNCILS BUT JUST HAVE THE REVIEW CYCLES SUBJECT TO TWO. A LARGE PART WAS DICTATED BY THE WHOLE ISSUE ABOUT THE BUDGET AND FUNDING AND GET RID OF THE LAST ONE, AND THAT COULD BE USED FOR OTHER PURPOSES AS WELL. >> I THINK IF WE COULD FIGURE OUT A WAY OF TRYING IT, IT'S -- THE IDEA THAT THERE IS A WAY BY MANIPULATING THE SUBMISSION CYCLES TO GET SIGN IT TISES TO LOWER THEIR NUMBER OF APPLICATIONS PER YEAR IS WORTH -- I'M TRYING IT DIFFERENT THINGS. I'D LIKE TO TRY IT ON SOME SUBSET OF APPLICATION LOAD BEFORE WE SCREW EVERYTHING UP INADVERTENTLY. >> I THINK THE PIECE OF THAT, I THINK THAT'S PART OF WHAT YOU WERE SAYING TOO, RICHARD, IS THINKING FOR THE APPLICANT'S POINT OF VIEW, IF YOU HAVE TWO SUBMISSIONS, ESSENTIALLY TWO REAL SUBMISSION DATES A YEAR, TO HAVE THEM SPACED IN SUCH A WAY THAT YOU COULD COME IN GET SOME FEEDBACK AND HAVE SUFFICIENT TIME TO MAKE THAT NEXT ONE, AND I THINK THAT WOULD HAVE TO BE THOUGHT THROUGH TOO, TO FIGURE OUT THE TIMING ON THOSE SO THE APPLICANT COMMUNITY DOESN'T FEEL LIKE THEY'VE BEEN OVERLY BURDENED BECAUSE OF THAT CHANGE. >> I THINK I CERTAINLY AGREE WITH EVERYTHING DID DELLA AND RICHARD ARE SAYING, THAT THIS WOULD BE A PRETTY RADICAL CHANGE AND WOULD PUT REAL BURDENS ON OUR ADMINISTRATIVE PROCESSES TO THINK ABOUT, BUT I STILL THINK IT'S AN INTRIGUING IDEA FOR US TO STRUGGLE WITH, AND I AM IMPRESSED WITH -- I WANT TO BRING TWO POINTS TO THIS, FIRST OF ALL WHAT WE'VE HEARD ABOUT THE IMPACT OF CHANGING THE ABILITY TO SUBMIT AT NSF, BUT I'M ALSO REMEMBERING BACK TO MY TIME AT THE UNIVERSITY OF OF MICHIGAN, I WAS VICE CHAIR OF THE DEPARTMENT OF MEDICINE FOR RESEARCH, AND WE HAD A VERY ACTIVE APPROACH, WHICH IS WE WANTED EVERYBODY TO HAVE A GRANT APPLICATION AS OFTEN AS POSSIBLE. AND IF THERE WAS THREE TIMES A YEAR, IT WAS MORE. NOW I KNOW FROM TALKING TO NANCY THAT THERE IS MANY INSTITUTIONS ARE THINKING HARD ABOUT THIS AND ARE ACTUALLY NOT SORT OF WHIPPING PEOPLE TO JUST WRITE GRANTS ALL THE TIME BUT ACTUALLY THINKING ABOUT SUCCESS IN THE GRANTS, BUT I THINK ONE OF THE THINGS THIS COMMITTEE HAS REALLY GOT TO STRUGGLE WITH IS ARE THERE WAYS THAT THE SYSTEM -- WE COULD CHANGE THE INCENTIVES FOR INSTITUTIONS, AND THERE IS A WAY IN WHICH YOU BUY MORE LOTTERY TICKETS, YOU MAY WIN MORE OFTEN. SO WE HAVE TO THINK ABOUT WHETHER THIS THIS MIGHT, IN FACT, HAVE THE IMPACT THAT HAS BEEN POSTULATED. I DON'T QUITE KNOW HOW TO DESIGN A TEST, BUT OBVIOUSLY IT'S THE KIND OF CHANGE ONE DOESN'T MAKE WITHOUT SOME MORE PRELIMINARY EVIDENCE THAT IT MIGHT HAVE THE INTENDED EFFECT. >> ONE COULD CONCEIVE OF TAKING CERTAIN MECHANISMS AND DOING IT IN THIS PROCESS, OR ONE OR TWO INSTITUTES COULD DECIDE THAT THEY WERE GOING TO TRY IT AS AN ALTERNATIVE. >> WE DID MENTION THIS MORNING WHEN YOU WEREN'T HERE THAT IT'S BECOMING INCREASINGLY CLEAR WITH THE COMPLEXITY ACROSS THE ENTIRE NIH THAT MAYBE SOME PILOTS IN VARIOUS PLACES TO TEST SOME OF THESE IDEAS MAY BE THE BEST WAY TO PROCEED. LINDA? >> SO ACTUALLY JOSIE SAID MANY OF THE THINGS I ACTUALLY WAS GOING TO SAY, BECAUSE I THINK TS IS A PARTNERSHIP AND WE NEED THE INSTITUTIONS TO WORK WITH US TO BRING ABOUT THE CHANGES. I MEAN, IT'S A HUGE A WORK FOR THEAMOUNT OFWORK FOR THEM AS WELL TO GET T HE APPLICATIONS AND ALL THE COSTING AND EVERYTHING OUT THE DOOR. I WOULD THINK THAT -- I'M NOT SURE WHERE THE RIGHT FORUM IS, SOME OF IT IS THE IDEA OF A PILEUP BUT SOME OF IT WOULD BE THE IDEA OF AN APPROPRIATE FOR YUM, YOFORUMTO SAY, YOU KNOW, WE THINK THA T THERE'S TOO MANY APPLICATIONS, YOU'RE DOING TOO MUCH, YOU'RE PUSHING YOUR PEOPLE TO DO IT ALL THE TIME, LET'S TALK ABOUT HOW WE CAN REDUCE THIS, WHICH WILL HELP EVERYBODY. >> IT'S REALLY HARD. IT'S HARD GOING FORWARD, EVEN WITH A PILOT, YOU'D WANT TO GET FEEDBACK FROM THE APPLICANT COMMUNITY, BECAUSE I THINK GOING FROM THREE TO TWO, MY GUESS IS IT WOULD BE PRETTY UNPOPULAR. ALSO NEED TO THINK THROUGH WHAT THAT WOULD MEAN AT AN INSTITUTIONAL LEVEL, BECAUSE IT WOULD BE LESS WORK FOR SOME OFFICES BUT IT MIGHT ALSO MEAN THAT WE HAVE TO KEEP PEOPLE AFLOAT LONGER THAN WE DO NOW. SO IT WOULD BE WORTH MODELING IT OUT PRETTY CAREFULLY TO GET THE SENSE OF WHAT THE IMPACT WOULD BE. >> IF THERE WAS A TWO-YEAR BUDGET AUTHORITY ROLLING SO THAT YOU KNEW WHAT THE FUTURE LOOKED LIKE, WOULD THIS THREE TO TWO BE LESS IMPORTANT? IT WOULD BE, RIGHT? >> YOU WOULDN'T REALLY KNOW WHAT THE FUTURE LOOKS LIKE, SO YOU WOULD STILL GET ANNUAL APPROPRIATIONS, IT WOULD JUST MEAN YOU COULD SPEND THE MONEY FROM ONE YEAR'S APPROPRIATION OVER A PERIOD OF TWO YEARS, BUT YOU'D STILL HAVE THE SAME UNCERTAINTY AT THE BEGINNING OF THE YEAR? >> IT MIGHT MAKE IT WORSE. >> WOULD IT BE WORSE? >> WELL, YOU KNOW, FROM MY PERSPECTIVE, THE BENEFITS OF HAVING MONEY AVAILABLE, THAT YOU CAN SPEND MONEY APPROPRIATED IN FY '15 IN '15 AND '16 IS THAT END OF THE YEAR CRAZINESS WHICH IS NOT JUST ABOUT AWARDING GRANTS, BUT ACTUALLY AFFECTS ALL OF THE MONEY THAT WE SPEND AND HOW FAST WE HAVE TO DO IT. >> GETTING BACK JUST TO ONE FACTOID THAT I'M PROBABLY WRONG, AM I CORRECT TO SAY THAT THE AVERAGE NUMBER OF APPLICATIONS PER INVESTIGATOR IS 1.4? SO IT'S NOT -- WE DON'T HAVE THIS PLETHORA OF PEOPLE SENDING IN 10 APPLICATIONS. I JUST WANT TO MAKE SURE THAT EVERYBODY KNOWS WHAT THAT FIGURE IS. >> WE ALSO LOOKED AT -- THIS IS ONE OF THE THINGS WE'VE LOOKED AT IN THE LAST YEAR OR SO. IT REALLY IS AFT DOUBLING WHERE YOU SEE THE HUGE INCREASE IN THE NUMBER OF APPLICATIONS. AND MOST OF THAT IS DUE TO OTHER PEOPLE COMING INTO THE SYSTEM. IT'S EXACTLY WHAT YOU SAID, STEVE, IT'S NOT ONE PERSON SITTING THERE CRANKING OUT FOUR APPLICATIONS A YEAR KIND OF THING AND THAT'S WHAT SORT OF CLOGGING UP THE SYSTEM. THERE ARE MORE PEOPLE WHO WANT TO BECOME PART OF THE SYSTEM AND WE HAVE THE STATUE OF LIBERTY POLICY, COME IN, YOU GOT AN IDEA. SO THAT'S WHERE THE BIG DRIVER IS, IS IN NEWER PEOPLE COMING IN TO THE SYSTEM. BECAUSE WE ALSO HAVE DATA THAT HAS INDICATED THAT DUE EVEN AFTER THE FIRST SUCCESSFUL RO1, SO LOOKING AT THE NEWER INVESTIGATORS WHO GET THEIR FIRST SUCCESSFUL RO1s, SO WE LOOKED AT VARIOUS EPICS OF TIME SO WE LOOKED AT PREDOUBLING DURING THE DOUBLING RIGHT AFTER THE DOUBLING KIND OF THING, AND IT'S A VERY SIMILAR KIND OF CURVE THAT ENDS UP WHERE YOU HAVE ALMOST 40 TO 50% OF YOUR POPULATION THAT OVER ABOUT AN EIGHT-YEAR PERIOD ARE NO LONGER IN THE POOL, IT WAS LONGER SO YOU HAD A LONGER PERIOD OF PEOPLE STAYING IN THE POOL DURING THE DOUBLING PERIOD, BUT BEFORE THE DOUBLING AND AFTER, IT SHRUNK. >> -- THE APPLICANT IS IMPORTANT BECAUSE THOSE PEOPLE PROMOTION MANY TIME IN MAJOR INSTITUTION -- THEIR ABILITY TO OBTAIN ANOTHE AN RO1 AND THEY WILL BE OUT OF THAT ACADEMIC GAME. >> I MAY HAVE MISUNDERSTOOD WHAT YOU JUST SAID, BUT I HAVE TO WONDER IF THE INCREASED NUMBER OF APPLICATIONS AND APPLICANTS DOESN'T ALSO HAVE TO DO WITH PEOPLE STAYING ACTIVE FOR LONGER BECAUSE I THINK THE AGE AT WHICH PEOPLE LEAVE THE SYSTEM HAS INCREASED. I WORRY, ACTUALLY I WORRY A LOT THAT THERE ARE FAR FEWER YOUNG PEOPLE COMING IN THAN WE ASSUME THERE ARE. BUT I THINK THAT PEOPLE'S CAREERS -- WE HAVE PEOPLE IN THEIR MID EIGH 80s WHO ARE STILL GOING -- >> WE DO. IN FACT, SOMEONE WALKED UP TO SALLY ABOUT A MONTH AGO VERY PROUD BLI IN THE CALIFORNIA SYSTEM AND EXHIBIT DUED HIMSELF, HE WAS 89 YEARS OLD AND HE JUST GOT HIS RENEWAL OF HIS RO1. THE DATA THAT I WAS SPEAKING TO REALLY WAS FOCUSED ON PEOPLE WHO WERE NEW TO THE SYSTEM. SO YOU'RE RIGHT, PEOPLE ARE STAYING LONGER IN THE SYSTEM BECAUSE WE ARE ALL, LUCKILY, BENEFITING FROM OUR SCIENCE AND STAYING HEALTHY AND PRODUCTIVE FOR LONGER PERIODS OF TIME. >> I SHOULD ADD, I'M NOT SURE IT'S A BAD THING BECAUSE I ACTUALLY DON'T BUY INTO THE IDEA THAT PEOPLE ARE MOST CREATIVE WHEN THEY'RE VERY YOUNG OR WHATEVER THE MYTH IS. SOME OF THE MOST CREATIVE SCIENTISTS I'VE KNOWN AND KNOW ARE OVER 65, SO -- >> THE EFFECT OF CHANGE OF POLICY ON STUDY SECTION BEHAVIOR ITSELF, WE KNOW THAT, FOR EXAMPLE WHEN THERE WAS THE ABILITY TO AMEND YOUR APPLICATION MORE THAN ONCE, SECOND AMENDMENT, THIS SWORD OF LESORT OFLED OVER TIME TO THE STUDY SECTION PUTTING PEOPLE IN QUEUES BEFORE THEY ACTUALLY ENDED UP GETTING THEIR FINAL AWARD. NOW THAT I IN THE AMENDMENT WAS SORT OF DROPPED AND THAT THEN SORT OF SHIFTED, YOU KNOW, MATHEMATICALLY WHEN PEOPLE WOULD GET THEIR GRANTS AND NOW THE FACT THAT WE'VE MOVED ACK TO THE ABILITY THAT AMEND MULTIPLE TIMES, I'M SURE OVER TIME -- AS WELL, SO IT WOULD BE NICE POTENTIALLY TO SIMULATE WHAT AN EFFECT OF A POLICY MIGHT BE IF YOU COULD RUN THAT, BECAUSE AGAIN, WE'RE TRYING TO OPTIMIZE MORE THAN ONE VARIABLE HERE. WE WANT TO TRY TO HAVE A PROCESS IN WHICH WE HAVE LESS BURDEN ON REVIEWERS, INCREASE THE NUMBER OF REVIEWERS SO AT THE SAME TIME, WE'D LIKE TO OPTIMIZE THE TIME FOR THE SUBMISSION TO THE ACTUAL DOLLARS IN HAND. SO THESE ARE ALL VARIABLES THAT I THINK HAVE TO BE CONSIDERED, AND SPECIFICALLY I THINK I HEARD YOU MENTION YOU MIGHT EVEN -- AFTER SIMULATING THIS, YOU'D WANT TO PILOT IT EITHER ALONG A CERTAIN MECHANISM OR BY CERTAIN ICs OR BOTH, PERHAPS, BECAUSE, YOU KNOW, DEPENDING UPON THE DISTRIBUTION OF GRANT OR STUDY SECTIONS THEY GO TO, YOU WANT TO MAKE SURE THAT WHAT YOU'RE ACTUALLY FUNDING, P IF IT WAS REPEATED, IT WOULD LIKELY BE REPEATABLE GREATER THAN 90% OF THE TIME. >> SCIENTISTS WILL ALWAYS TRY AND FIGURE OUT, WHAT'S THE BEST STRATEGY IN A GIVEN SET OF RULES THAT WE MAKE UP, SOMETIMES WE DON'T THINK THROUGH THE WAYS IN WHICH A GAME CAN BE PLAYED. >> TO ARTICULATE WHAT MAY BE A SOMEWHAT UNPOPULAR VIEW, BUT LISTENING TO RICHARD'S COMMENTS A FEW MINUTES AGO WHILE ALL OF US WOULD AND DO ADVOCATE FOR GREATER SPENDING FOR RESEARCH, I WORRY THAT BY EFFORTS TO TRY TO SUSTAIN AN UNSUSTAINABLE SIZE OF THE ENTERPRISE, WE'RE DOING A LOT OF HARM. AND BY THESE EFFORTS TO KEEP THE MAXIMUM NUMBER OF SCIENTISTS IN THE GAME AND SO FORTH, THAT WOULD BE GREAT IF WE REALLY, REALLY BELIEVE THAT IN THE FORESEEABLE FUTURE, THERE'S GOING TO BE A CHANGE IN THE FUNDING ENVIRONMENT. SO I WORRY ABOUT PROPOSALS THAT BUY TIME FOR PEOPLE AND SO FORTH, BECAUSE THOSE ARE DOLLARS THAT ARE TAKEN AWAY FROM OTHER RO1s THAT COULD BE SUPPORTED. THAT'S NOT THE MOST OPTIMISTIC VIEW OF THE FUTURE, BUT I THINK IT'S SOMETHING WE HAVE TO THINK ABOUT. >> I COMPLETELY AGREE, I THINK THE SIZE OF THE PIE IS GOING TO CHANGE. THAT'S REALLY THE POINT TO, I THINK, THE FIRST OF OUR GUESTS MADE, AND THAT IS ALTHOUGH WE TRY TO DO IT, US A HEARD, I SAID THAT IN OUR INSTITUTE, WE'RE EXPANDING ONCE SOMEONE HAS RENEWED THEIR APPLICATION, EXPANDING THEIR RESEARCH TO A PROGRAM, BUT TO EXTEND, FOR EXAMPLE, THE FIRST AWARD OR TO DO AN ENORMOUS AMOUNT OF BRIDGE FUNDING, THERE'S ONLY ONE SIZE OF THE PIE. AND THAT IS THE ISSUE. >> SO SPEAKING TO THAT DISCUSSION, THEN I WOULD ALSO ADVOCATE EFFORTS TO MAKE THE REVIEW PROCESS AS PRODUCTIVE AND AS FAIR AS POSSIBLE SO THAT INDIVIDUALS DO GET THE MOST PRODUCTIVE FEEDBACK AND ADVICE ON HOW TO GO FORWARD. ONE OF THE MOST FRUSTRATING THINGS FOR ME PERSONALLY THAT I'VE MENTIONED BEFORE IS WORKING VERY HARD TO SUBMIT A PROPOSAL AND THEN HAVE IT TRIAGED WITHOUT ANY RESPONSE/COMMENTS, SO ANY EFFORTS MADE SUCH THAT -- EITHER A SELECTION OR SOME OTHER MECHANISM IN THAT THE QUALITOF THE REVIEW, PROVIDING INCENTIVES FOR THE REVIEWERS, MAKING THAT PROCESS MORE EFFECTIVE AND MORE FAIR, BLIND REVIEW, FOR EXAMPLE, MORE FAIR, WOULD BE BENEFICIAL TO EVERYONE, THEN, BECAUSE YOU WOULD PROMOTE THE BEST GRANTS, YOU WOULD DECREASE THE BURDEN ON THE VARIOUS INDIVIDUALS, AND HOPEFULLY THE OUTCOME WOULD BE BETTER FOR ALL. >> POINTS WELL TAKEN. THE ISSUE I'VE BEEN HIT OVER THE HEAD WITH SO MANY TIMES, I KNOW THE NUMBERS OF JUST SHY OF 86,000 GRANTS, AND JUST SHY OF 16,000 REVIEWERS, SO WE GIVE SUBSTANTIVE FEEDBACK TO EVERY PROPOSAL THAT MAKES ITS WAY INTO THE SYSTEM. YOU COULD ARGUE THE SYSTEM IS UNDER SEVERE STRESS, YOU COULD EVEN GO SO FAR AS TO SAY IT'S BROKEN NOW AND WAS PROBABLY BROKEN A FEW YEARS AGO AND THE NUMBERS KEEP INCREASING. THAT'S THE ISSUE. EVERY PROPOSAL THAT MAKES ITS WAY INTO REVIEW OUGHT TO GET A SUBSTANTIVE REVIEW. THE NUMBERS OF PROPOSALS HAVE OUTSTRIPPED THE ABILITY TO DO THAT. AND SO SOMEWHERE -- REDUCE THE NUMBER OF PROPOSALS. TAKE SOME SMALLER NUMBER AND PUT THEM INTO FULL REVIEW BY SOME PRESCREENING PROCESS. THERE'S A SORT OF A COMMON THEME THROUGHOUT ALL OF THIS AND THAT IS THAT THE WORKLOAD IS TOO HIGH, IT DOESN'T SHOW ANY SIGNS OF CHANGING AND THE POT OF MONEY IS GOING TO STAY THE SAME. AND SO HOW DO WE SERVE THE COMMUNITY BEST, AND AT THE SAME TIME, COMING BACK TO WHAT RICHARD SAID, THE SYSTEM WAS NOT PULT IN PLACPUT IN PLACE, FOR EXAMPLE, TO ED KAEDUCATE GRADUATE STUDENTS. IT WAS PUT IN PLACE TO MAKE THE COUNTRY HEALTHY. SO TO MAKE DISCOVERIES THAT WOULD MAKE THE COUNTRY HEALTHY. SO WHAT WE SPEND THE MONEY ON AND HOW WE ALLOCATE THE MONEY, ALL THAT, I THINK, SHOULD BE ON THE TABLE, BUT OUR BIGGEST ISSUES RIGHT NOW IS THE POT STAYS THE SAME, THE NUMBERS ARE WAY TOO BIG, TO DO IS A GOOD SUBSTANTIVE REVIEW OF EVERY PROPOSAL THAT COMES IN. SO I'M IN FAVOR OF TRYING TO FIND WAYS TO LIMIT WHAT THE STUDY SECTIONS ARE DOING, SMALLER NUMBERS, SO THAT IF IF YOURS IS IN THAT POOL, YOU CAN GET THE KIND OF REVIEW AND IT'S GOING TO BE VERY HELPFUL IF IT ISN'T FUNDED, IF WE CAN HAVE A PRESCREENING -- PEER REVIEWED PRESCREENING THAT SENDS SOME OF THE IDEAS CAN BACK TO SAY LET'S NOT GO THROUGH THE WHOLE PROCESS BECAUSE YOU NEED TO RE-THINK THIS, THAT SHOULD BE HELPFUL TOO. AND AGAIN, ALL MY COMMENTS, YOU HAVEN'T HEARD ME MENTION TIME ONES, WHICH I REALIZE IS STILL ONE OF THE CHARGES OF THIS WORKING GROUP, IS TO SHORTEN THE TIME. >> I THINK SOME OF THE BURDEN SHOULD BE ON THE ACADEMIC INSTITUTIONS AND THE APPLICANT. THERE USED TO BE A TIME WHERE THERE WAS THE STUDY SECTION, WE WROTE A THREE, FOUR, FIVE-PAGE REVIEW. IT'S NOT AN EDUCATIONAL PROCESS ANYMORE. SO WITHIN THE INSTITUTION, YOU SHOULD FIND SENIOR ESTABLISHED INVESTIGATOR COMMITTING THEMSELVES AND NOT APPLICANT TO CONSULT, TO WORK WITH OTHER PEOPLE IN THE FIELD TO THE PROFESSIONAL SOCIETIES, SEND YOUR DRAFT OF THE APPLICATION, GET FEEDBACK, AND PUT OUT THE PRODUCT THAT IS AS STRONG AS YOU CAN, BUT YOU CAN'T ASK THE REVIEWERS SO SIT AND GO THROUGH THIS. IT'S TOO MUCH WORK. >> RAH KEL, I THINK THAT'S A REALLY INTERESTING OBSERVATION ON YOUR PART BECAUSE A FEW YEARS AGO, WE, ALL OF US, WENT THROUGH A LARGE EFFORT AND WE CALLED IT PEER REVIEW ENHANCEMENT. WE WENT THROUGH A LOT OF DISCUSSION WITH THE COMMUNITY, INTERNALLY. THERE WERE MANY PIECES, BUT ONE OF THE PIECES WAS BASICALLY WHAT YOU JUST SAID, WHICH WAS THE PEER REVIEW REALLY WASN'T SUPPOSED TO BE MENTORING, IT WAS SUPPOSED TO BE SORT OF TELLING PEOPLE ABOUT THE ADEQUACY -- TECHNICAL ASPECTS, IF YOU WILL, ABOUT THEIR APPLICATION. IT'S INTERESTING TO ME TOO HEARING YOU SAY THAT, BECAUSE WE CHANGED BUT THE ACADEMIC -- WHAT I HEARD FROM YOU WAS THAT THE AK DEMIC INSTITUTIONS DIDN'T NECESSARILY CHANGE THEIR STANCE ABOUT WHAT THE ROLE OF PEER REVIEW WAS, SO IF THE MENTORING COMPONENT IS NEEDED, AND I'D BE ALL A BIG FAN FOR THAT, I VALUE THAT TREMENDOUSLY, THEN HAVING IT PICKED UP AT THE INSTITUTIONAL LEVEL TO PROVIDE THAT KIND OF THING BECAUSE THIS WAY NOW OF DOING SUMMARY STATEMENTS AND SO FORTH IS NOT DOING IT ANY LONGER MIGHT BE A PARTICULAR WAY TO ACTUALLY HELP TOO WITH INSTITUTIONAL TRIAGING. BEFORE -- >> NANCY WANTS IT TO SPEAK TO THAT. I KNOW A NUMBER OF INSTITUTIONS ARE TRYING TO GET AWAY FROM THIS LOTTERY MENTALITY AND TRYING TO MENTOR BEFORE THE APPLICATIONS COME OUT. YOU DO HAVE SOMETHING SPECIFIC. >> ABSOLUTELY. WE DO HAVE AVAILABLE, IT'S NOT REQUIRED, BUT MANY PEOPLE TAKE ADVANTAGE OF HELP WITH PUTTING TOGETHER AND PRE-REVIEWING APPLICATIONS AT THE DIVISION OR DEPARTMENT LEVEL, AT THE SCHOOL LEVEL, WE'VE GOT MULTIPLE MECHANISMS FOR DOING THAT. WE DON'T REQUIRE IT. THERE ARE APPLICATIONS THAT GO IN THAT HAVEN'T BEEN THROUGH IT, BUT IT'S USED HEAVILY. >> SO WITH SOME OF OUR EARLY INVESTIGATIVE PROGRAMS, WE REQUIRE INSTITUTIONAL SUPPORT IN THAT THEY CAN ONLY SUBMIT PER COLLEGE WITHIN AN INSTITUTION ONE, SO THAT REQUIRE AS CERTAIN AMOUNT OF TRIAGING THAT'S GOING ON AT THE INSTITUTIONAL LEVEL. >> I ACTUALLY WORRY ABOUT BIAS WITH THAT BECAUSE I THINK THE SAME PEOPLE TEND TO GET THE NOMINATION OVER AND OVER AGAIN. >> EXCEPT THESE ARE -- WE'RE DOING IT WITH EARLY STAGE, IT'S A MORE RESTRICTED GROUP, MAYBE YOU HAVE BIAS WITHIN THAT GROUP. >> I WORRY ABOUT IT. >> MAY OWN EXPERIENCE WITH THAT, WITH HHMI, I THINK ONE OF THE BEST THINGS THAT HHMI DID WAS TO TAKE IT OUT OF THE INSTITUTION MAKING NOMINATIONS, BUT IT WAS TORTUOUSLY POLITICAL IN A LOT OF PLACES, AND WHEN THEY JUST WENT TO THE OPEN COMPETITION MODEL, I THINK IT ERASED ALL OF THAT. IT CREATED A LOT OF BURDEN OF WORK ON THEM, BUT THAT'S NO NEWS TO ANY OF YOU HERE. >> JUST A FEW COMMENTS. ONE THAT I THINK DR. CASS MENTIONED THIS MORNING THAT MANY OF THE SOCIETIES, I WAS ACTUALLY THREE YEARS AGO ON ONE OF THOSE GROUPS, THAT REALLY WE MENTORED OUTSIDE SO IT PULLED IT OUT OF THE UNIVERSITIES, AND I THINK MAYBE THAT NEEDS TO BE EMPHASIZED AND BROUGHT BACK AGAIN. AS I WAS SITTING HERE, I WAS SOMEWHAT AGAINST THE PRE-SCREENING UNTIL I HEARD FROM EVERYBODY AND I'M NOW BACK AGAINST IT AGAIN. [LAUGHTER] >> BUT PERHAPS THINKING OF IT IN A DIFFERENT WAY. WHAT I'M CONCERNED -- WE'RE PROMOTING A SCIENCE OF LOWER QUALITY THAN IN THE PAST. I'M NOT SURE IF THAT'S TRUE OR NOT BUT I HAVE CONCERNS RELATED TO THAT. WHAT IF, WHEN YOU SUBMITTED YOUR PROPOSAL, SO IT'S LIKE A SCREENING WHERE YOU GET NO FEEDBACK, WHEN YOU SUBMIT YOUR PROPOSAL, YOU HAVE TO HAVE A THREE-PAGER WITH THAT, AND THAT BECOMES THE TRIAGE. THAT DOESN'T BURDEN THE REVIEWER BECAUSE THE REVIEWER HAS TO RESPOND TO A TRIAGE, AND THEY SOMEWHAT DO IT SUPERFICIALLY, SO IT'S OF NO VALUE, CAN'T REALLY FIGURE OUT WHAT CAN -- SO I'M WONDERING IF THAT'S ANOTHER WAY OF PRE-SCREENING THAT MAYBE, IN FACT, ENHANCES AND WOULD BE MORE RAPID THAN WE HAVE NOW. JUST A THOUGHT. >> MARTHA, CAN YOU EXPLAIN THAT A LITTLE MORE? SOMEHOW I GOT LOST. >> SO WHEN YOU PUT IN YOUR GRANT PROPOSAL, AT THE SAME TIME, YOU PUT THAT IN, YOU HAVE TO HAVE A THREE-PAGER. THE REVIEWERS ONLY READ THE THREE-PAGER AT THE TRIAGE, AND THAT TRIAGE, THEY DON'T HAVE TO EXPLAIN. IT'S LIKE YOU'RE PRE-SCREENING. >> WELL, WE DID HEAR DISCUSSION ABOUT THAT OF EVEN A PRE-SCREENING WOULD BE AN OPPORTUNITY FOR FEEDBACK. SO I GUESS WHAT I'M SAYING IS YOU'RE GOING TO HAVE THEM, IN ADDITION TO THEIR GRANT PROPOSAL, THEY'VE GOT TO PUT AN EXTRA SOMETHING THERE, BUT THAT'S ALL THE REVIEWERS MIGHT HAVE TO READ IF THEY DIDN'T LIKE IT. >> RIGHT. RIGHT. >> IT STEL SEEM STILL SEEMS LIKE A LOT OF WORK FOR THE APPLICANT TO PUT TOGETHER. BUT I WANTED TO COMMENT JUST BRIEFLY ON THE INSTITUTIONAL SUPPORT. I THOUGHT THAT WAS A REALLY INTERESTING IDEA. I THINK MANY INSTITUTIONS HAVE GRANT PEER REVIEW, MY INSTITUTION HAS THAT IN TERMS OF SENIOR INVESTIGATORS HELPING THE JUNIOR MID CAREER. SO AGAIN, ONE IDEA, IF THE NUMBER OF APPLICANTS IS GOING TO BE CONSISTENT BUT TRYING TO STRATIFY THEM, IF YOU CAN HAVE A LETTER OF INSTITUTE SUPPORT SAYING THIS APPLICANT WENT THROUGH A PRE-APPLICATION PROCEDURE WITH WHATEVER, AS SOME KIND OF MECHANISM TO STRATIFY THE APPLICANTS SUCH THAT AGAIN, HAVING BETTER APPLICATIONS MAKE IT TO THE PEER REVIEW PORTION IN ORDER TO MAKE MORE -- TO MAKE THE MOST OUT OF THE TIME THAT THE REVIEWERS ARE GIVING. I DON'T KNOW IF THAT'S POSSIBLE. >> I'M A BIT OF A SKEPTIC ON THAT. I'M AFRAID I'LL GO BACK TO MY EXPERIENCE WITH HHMI. I'M ON THE SCIENTIFIC REVIEW BOARD AND HAVE BEEN FOR EIGHT OR NINE YEARS NOW, AND EVERY INSTITUTION HAS TO WRITE A LETTER OF SUPPORT. YOU MIGHT IMAGINE, I KNOW THERE ARE LETTERS THAT HAVE BEEN WRITTEN THAT I'VE SEEN, PEOPLE AROUND THIS TABLE HAVE WRITTEN, RIGHT, LARRY? [LAUGHTER] >> NO, THESE ARE OUTSTANDING PEOPLE, BUT MY POINT IS THAT THOSE LETTERS ARE ALWAYS EX-TOLLING THE VIRTUES OF THOSE PEOPLE. I THINK IF WE'RE LOOKING FOR WAYS TO HAVE LESS BURDEN ON THE INSTITUTION, WE WANT THEM TO TAKE A MORE ACTIVE ROLE IN HELPING INVESTIGATORS WRITE THOSE PROPOSALS. BUT I DON'T THINK WE WANT TO PUT THEM IN THE JUDGMENT ARENA. EVERYBODY NEEDS TO SEND THEIR APPLICATION IN, IT IF THEY THINK THAT THERE'S SOMETHING THEY'RE EXCITED ABOUT AND THEY THINK IT'S THE BEST PROPOS THEY COULD POSSIBLY WRITE. THE LAST PARLT OF THAT I THINK IS THE MOST IMPORTANT, IS IT THE BEST PROPOSAL THEY COULD POSSIBLY WRITE, AND THAT'S WHERE THE INSTITUTION COULD HELP THEM. >> ONE REALLY INTERESTING RESULT FROM THE OFFICES OF EXTRAMURAL RESEARCH WAS AN EXAMINATION OF THE TOP 100 RESEARC INSTITUTIONS WHERE THEY FOUND THAT SOME OF THOSE INSTITUTIONS HAD SUCCESS RATES AS LOW AS 15%. BELOW THAT EVEN. OTHERS HAD SUCCESS RATES AROUND 35%. AND THERE WAS NO RELATIONSHIP TO THE -- I GUESS THE DOLLARS THAT THE INSTITUTION RECEIVED. SO SOMEHOW, SOME INSTITUTIONS WERE ABLE TO STEADILY DO MUCH BETTER THAN AVERAGE AND SOME MUCH WORSE THAN AVERAGE. WE'VE REALLY NEVER ANALYZED WHY THAT WAS THE CASE, BUT I UNDERSTAND FROM A YEAR THAT HOLDS. >> ONE OF THE THINGS THAT WAS VERY SURPRISING, AT LEAST IT WAS TO ME, THE DATA, IF WHEN YOU LOOK OVER YEARS AND STUFF LIKE THAT, HOW REMARKABLY STABLE OUR DATA REALLY ARE. AND THIS >> AND OUR SUCCESS RATE. >> EXACTLY, THAT'S CHANGED, BUT IN TERMS OF THE INSTITUTIONS AND TYPES OF INSTITUTIONS, ET CETERA, AND WHO'S GETTING THE CHUNK OF -- VARIOUS CHUNKS OF PROPORTIONATELY THE MONEY, IT REMAINS REMARKABLY SIMILAR. SO WHEN WE LOOKED AT THIS INSTITUTIONAL SUCCESS RATE, IF YOU WILL, IT WAS VERY INTERESTING TO SEE HOW -- WHAT COMES TO MY MIND IN TERMS OF THAT DATA THAT SOME OF THE ORGANIZATIONS WHICH WERE MORE RESEARCH INSTITUTIONS AS WELL AS RESEARCH HOSPITALS HAD A VERY EFFECT -- ARE DOING SOMETHING BECAUSE THEY HAVE A VERY GOOD, VERY SUCCESS RATE, VERSUS OTHER SCHOOLS WHICH SEEM TO BE DOING MORE WITH -- JOSIE WAS TALKING ABOUT A LOTTERY WHERE WE WERE GETTING TONS OF APPLICATIONS, THEY WERE GETTING AWARDS, BUT IT WAS A AT A HUGE COST ESSENTIALLY, A LOT OF INEFFICIENCY, WHICH IS ONE OF THE WORDS THAT WE WERE USING EARLIER. I DON'T KNOW WHAT'S DRIVING THEIR STRATEGIES. I DON'T KNOW. >> I THINK IT WOULD BE INTERESTING IF IT'S PRAGHT PRACTICAL TO RESURRECT SOME OF THAT DATA AND THEN PERHAPS ALSO TALK TO RESEARCH DEANS FROM A FEW PLACES THAT SEEM TO HAVE PARTICULARLY USEFUL MODELS. AS WELL AS THE OPPOSITE. >> I THINK THE DEPARTMENT CHAIRS ARE A BIG FACTOR IN THAT, AND WHAT KIND OF CULTURE THEY DEVELOP. BECAUSE WE HAVE JUST AM OUR AMONG OUR CHAIRS, THERE'S SOME THAT PUSH FOR LOTS OF SHOTS ON GOAL AND THERE ARE OTHERS WHO WANT TO PERSONALLY READ EVERY APPLICATION BEFORE IT GOES OUT, SO I THINK THAT'S A BIG VARIABLE THERE. >> WE ARE APPROACHING THE END OF THE TIME THAT WE HAVE. I'M SURE I SPEAK FOR THE WHOLE WORKING GROUP TO SAY THAT THE DISCUSSION SO FAR TODAY HAS BEEN VERY HELPFUL TO US, WE'RE USED TO JUST ARGUING AMONGST OURSELVES AND IT WAS A REAL PLEASURE TO ARGUE WITH ALL OF YOU TODAY. [LAUGHTER] >> THE ISSUE THAT HAS SURFACED, WHICH I FEEL VERY STRONGLY ABOUT BUT DON'T REALLY SEE IT FALLING UNDER THE PURVIEW OF WHAT WE'RE TRYING TO DO HERE, IS THE SIZE OF THE SYSTEM, WHAT'S SUSTAINABLE, AND WHAT IT MEANS TO THE QUALITY OF WHAT WE PRODUCE. I'M VERY CONCERNED ABOUT THAT, BUT THAT SEEMS TO ME BEYOND WHAT THIS WORKING GROUP SHOULD BE WORRIED ABOUT. THOUGH I WOULD SAY ANY RECOMMENDATIONS THAT COME FROM THE WORKING GROUP, IF THERE'S ANYTHING THAT IN SOME WAY LEADS TO SUPPORT OF NOT THE BEST SCIENCE, THAT I KNOW I WON'T BE THE ONLY VOICE IN THE WORKING GROUP AND PROBABLY 100% WOULD BE OPPOSED TO ANYTHING ALONG THOSE LINES. WITH THAT SAID, IT'S EASILY SAID, GIVEN THE SIZE OF THE SYSTEM THAT YOU MIGHT ARGUE IS NOW TOO BIG, NOT SUSTAINABLE FOR THE DOLLARS THAT GO INTO IT, GENERATES SOME VERY SERIOUS QUESTIONS, AND RICHARD, YOU ARTICULATED THEM WELL WITH YOUR CNTS A WHILE AGO. SO WE WILL TAKE ALL OF THE POINTS. FORTUNATELY AS I ALREADY COMPLIMENTED THE STAFF, THEY WILL PRODUCE THIS DIFFUSE DISCUSSION TODAY AN INTO SOMETHING COHERENT FOR US TO CONTINUE TO TALK ABOUT. SO I DON'T KNOW IF THERE ARE ANY OTHER IT -- STELLA. >> I'D JUST LIKE TO SAY THANK YOU FOR TAKING THE TIME AND EFFORT. I WAS VERY PLEASED THIS MORNING IN LISTENING TO YOU ALL'S DISCUSSION. THE COMPLEXITY OF THIS CAN BE A LITTLE DAUNTING, SO IT'S VERY GRATIFYING TO HAVE OTHERS SORT OF, A, APPRECIATE THAT COMPLEXITY, AND THEN COME UP WITH SOME SUGGESTIONS AND IDEAS FOR US TO THINK ABOUT, BECAUSE IT IS VERY -- WE'VE ALL BEEN STRUGGLING IN TRYING TO FIGURE OUT HOW BEST TO DO THIS, GIVEN WHAT WE JUST TALKED ABOUT, BUT THIS PIE DOESN'T SEEM TO BE GROWING ANY LONGER AND WE'VE GOT A HUGE NUMBER OF TALENTED PEOPLE AND LOTS OF GREAT SCIENCE, AND I THINK THE IDEAS THAT YOU ALL HAVE FLOATED CAN BE QUITE PROVOCATIVE FOR SOME OF US TO BE THINKING ABOUT INTERNALLY, SO I WANT TO THANK YOU VERY MUCH. >> MOST WELCOME. ANY OTHER COMMENTS? OKAY. THANK YOU. >> MICHAEL, THANKS TO YOU AND TO YOUR WORK GROUP, DELLA, RICHARD, THANK YOU VERY MUCH, SPECIAL THANKS TO OUR GUEST PANEL FOR YOUR HELP TODAY. IF YOU HAVE FURTHER THOUGHTS, YOU KNOW HOW TO FIND US. WE WOULD WELCOME THEM. IT'S ONE OF THESE ISSUES THAT EVERY SOLUTION THAT ONE COMES UP WITH, THERE ARE PROBLEMS WITH IT. ON THE OTHER HAND, THERE IS A FUNDAMENTAL PROBLEM WE'RE TRYING TO SOLVE, AND TO JUST CONTINUE ON CURRENT PATH DOESN'T SOWD LIKE AN ADEQUATE ANSWER, SO GOOD LUCK. [LAUGHTER] IN WAY OF A SUMMARY. >> OUTGOING CHAIR SAYS GOOD LUCK -- [LAUGHTER] >> MAKES YOU WONDER. >> THAT'S MY GUIDANCE. BUT YOU KNOW, THE FUNDAMENTAL PEM, UNFORTUNATELY, REALLY UNFORTUNATELY, IS THAT THE SIZE OF THE ENTERPRISE DOESN'T MATCH THE RESOURCES OF THE EPT PRIZE, AND NANCY AND I, OUR GOAL, THE OTHER GROUP THAT'S ADDRESSING THAT ISSUE, THAT'S HAVING EVERY BIT AS MUCH TROUBLE COMING TO AGREEMENT, SO OUR WORK LIES AHEAD. AT THIS POINT WE SH SWITCH TOPICS TO THE PRE-COLLEGE ENGAGEMENT IN THE BIOMEDICAL SCIENCES GROUP. CLYDE YANCY AS YOU KNOW, HAS BEEN CHAIRING THAT, BEEN DOING ALSO A TERRIFIC JOB IN PULLING TOGETHER, THERE'S A LITTLE DIFFERENT CHARACTER TO THIS, BUT ALSO HAS SOME DIFFICULT ISSUES. PART OF IT HAS TO DO WITH THERE ARE SO MANY FRAGMENTED ENDEAVORS AROUND THE COUNTRY INCLUDING AT NIH TRYING TO BE SURE WE GET OUR MONEY'S WORTH AND WHAT WE DO DO IS REALLY A CHALLENGE. MEASURE ONE BY ONE, THEY ALL LOOK WORTHWHILE, BUT WHEN ADDED TOGETHER, ONE HAS TO MAKE CHOICES. SO CLYDE, IF I'M NOT MISTAKEN, YOU'RE ON THERE, I HOPE, IS THAT CORRECT? IF SO, I'M GOING TO TURN IT OVER T YOU FOR YOUR PRESENTATION. >> WELL, I AM, AND I'D LIKE TO THANK YOU FOR THE OPPORTUNITY TO JOIN IN. IS EVERYONE ABLE TO HEAR ME OKAY? I'M GOING TO DO MY BEST TO SPEAK CLEARLY AND I'M USING THE HANDSET. >> VERY WELL DONE. >> OKAY, TERRIFIC. WELL, NORM, THANK YOU FOR THE OPPORTUNITY TO PRESENT THE WORK THAT OUR WORKING GROUP HAS BEEN ADDRESSING AND SPECIAL THANKS TO EVERYONE FOR INDULGING MY ABSENCE. I WOULD ORDINARILY HAVE DONE EVERYTHING POSSIBLE TO BE THERE, BUT BETWEEN WORK AND WITH MY FAMILY ARRIVING FOR A FEW DAYS FOR THE HOLIDAYS, I REALLY WANTED TO AND NEEDED TO STAY IN CHICAGO TODAY AND THROUGH THIS WEEK, SO MY APOLOGIES FOR NOT BEING THERE, BUT MY THANKS FOR THE OPPORTUNITY TO PRESENT OUR WORK. LET ME START WITH OUR APPROACH, AND -- TO SAY THANK YOU. AS A NUMBER OF NON-FEDERAL MEMBERS AND A NUMBER OF FEDERAL MEMBERS THAT SAT ON A COMMITTEE COMMISSIONED BY OUR DIRECTOR, FRANCIS COLLINS, TO ADDRESS SOMETHING THAT NOT ORDINARILY WOULD BE UNDER THE STRICT PURVIEW OF THE NIH TO LOOK AT THE PREPAREDNESS AND THE REPRESENTATION OF THOSE YOUNG ADULTS THAT ARE ENTERING COLLEGE AND GRADUATE SCHOOL, ANTICIPATING CAREERS IN BIOMEDICAL SIG SCIENCE, SOMETHING WE NOW CALL PEBS, OR PRECOLLEGE ENGAGEMENT OF THE BIOMEDICAL SCIENCES. TO NANCY, NORM, LEE AND GILL, MY TREMENDOUS THANKS FOR THE WORK THEY'VE DONE TO HELP US, AND TO JNE, GARY, ALAN, STEVEN AND RODERIC, THE SAME THING. I DON'T THINK ANY EFFORT CAN BE SUCCESSFUL IF YOU DON'T HAVE A GROUP OF PEOPLE THAT ARE ENGAGED AND ABC HEWITTLY EVERY PERSON WAS ENGAGED AND CONTRIBUTED SUBSTANTIALLY TO THIS REPORT. LET ME TAKE US BACK TO THE VERY BEGINNING BECAUSE I THINK THIS IS THE RIGHT WAY TO START. ON SLIDE 3, YOU SHOULD SEE THE CHARGE. THE CHARGE GIVEN TO US WAS TO RECOMMEND WAYS TO OPTIMIZ OPTIMIZE'S PRECOLLEGE PROGRAMS AND INITIATIVES BOTH IN LINE WITH THE NIH MISSION AND ENSURE A CONTINUED PIPELINE WITH BIOMEDICAL STUDENTS AND OFFICIALS. WE ADOPTED THIS GRAPHICAL REPRESENTATION OF OUR TASK AS A STAIR STEP FROM THE EARLY GRADES, PARTICULARLY KINDERGARTEN AND EARLY CHILDHOOD EDUCATION, TO THE POINT OF A ATTAINING A HIGH SCHOOL DID DI LOMA ANDIPLOMAAND DEGREE ENTERING INTO A BIOLOGICAL PROFESSION. THOSE THAT MAY HAVE BEEN ENGAGED WHEN THIS WAS FIRST DELIVERED TO US WILL REMEMBER THAT OUR FIRST EVIDENT WAS TO NAVIGATE SOME SENSE OF CONFUSION FROM THE EXTERNAL COMMUNITY. CAN WE NOT AS GROUP ALREADY HAD DIALOGUE, THAT WE WERE EDUCATING TOO MANY HAD A GLUT OF INDIVIDUS WHO WERE ORED AND SHOULD WE NOT FOCUS OUR ATTENTION ELSEWHERE. THAT WAS OUR BEGINNING, BUT IT SORT OF GALVANIZED OUR EFFORTS TO BETTER UNDERSTAND EXACTLY WHAT WAS THE STATE OF THE ART, WHAT WAS THE PREPAREDNESS AND WHOM EXACTLY WAS IT THAT WE WERE EDUCATING INTO CAREERS AND INTO THE BIOMEDICAL WORKFORCE, AND THEN IN A MORE POINTED WAY, WHAT IS A CAREER IN THE BIOMEDICAL WORKFORCE? WE ACTUALLY HAD A VERY HEALTHY EXERCISE TO UNDERSTAND THAT. SO IF I GO ON TO SLIDE 4, ELEMENTS OF THE CHARGE, YOU CAN SEE THERE WERE SEVERAL THINGS THAT WE WERE EXPECTED TO ACCOMPLISH. ITEM 1 QAS TO EXAMINE THE EVIDENCE BASE, IF ANY, FOR SUCCESSFUL APPROACHES FOR PRECOLLEGE BSM SCIENC BIOMEDICAL SCIENCE PMS AIMED AT STRENGTHENING THE OVERALL PIPELINE. NUMBER TWO, TRY TO UNDERSTAND THE CHARACTERISTICS, THAT IS, THE ATTRIBUTES, ACTIVITIES AND COMPONENTS OF EFFECT ITTIVE PRECOLLEGE BIOMEDICAL SCIENCE PROGRAMS. PARTICULARLY THINKING ABOUT TEACHER-TRAINED PROGRAMS. NUMBER THREE, LOOKING AT THOSE POINTS IN THE BIOMEDICAL WORKFORCE PIPELINE AT THE PRECOLLEGE LEVEL WHERE NIH MIGHT HAVE A UNIQUE ROLE AND MIGHT BE ABLE TO EFFECTIVELY APPLY THE FINITE RESOURCES THAT ARE AVAILABLE TO DO SOMETHING LIKE THIS, AND THEN THE FOURTH WAS TO DEFINE WAYS FOR THE NIH TO IMOF PROVE THE EVIDENCE BASE TO UNDERSTAND WHAT TRULY CONSTITUTES AN EFFECTIVE PRECOLLEGE BIOMEDICAL SCIENCE PROGRAM. IT'S IMPORTANT TO AGAIN STEP AWAY FROM THIS GRAPHIC AND THINK ABOUT WHAT'S NOT ON HERE THAT IS IMPLIED BUT NOT STATED. WE WERE NOT TASKED WITH DOING A DEEP DIVE ON THE ENTIRETY OF SECONDARY HIGH SCHOOL/ELEMENTARY EDUCATION. WE REALLY WERE GIVEN TASK TO THINK ABOUT THAT PROCESS AS IT UNIQUELY APPLIES TO EITHER THE MN OF THE NIH OR THE BIOMEDICAL WORKFORCE THAT THE NIH SUPPORTS, SO THAT SHOULD BE KEPT IN CONTEXT AS WE CONTINUE THIS DISCUSSION. WHAT ARE THE GENERAL FINDINGS? THESE APPEAR ON SLIDE 5. DESPITE THE EARLY CRITIQUE WE EXPERIENCED THAT THIS MIGHT HAVE BEEN A MISPLACED STRATEGY BECAUSE OF THE NUMBERS OF PH.D.s AND OTHER BIOMEDICAL SCIENTISTS THAT ARE ALREADY IN THE WORKFORCE, WE ACTUALLY FOUND ALARMING TRENDS TO SUGGEST THAT THE CURRENT AND RISING SCIENTIFIC WORKFORCE MAY, IN FACT, NOT BE FULLY PREPARED TO ADDRESS THIS COMPLEX ENVIRONMENT OF BIOMEDICAL RESEARCH THAT IS EVOLVING QUICKLY OVER TIME, AND ESPECIALLY WE WERE STRUCK TO DISCOVER THAT IT IS VIRTUALLY ABSENT OF THE DIVERSITY THAT MIRRORS OUR POPULATION. THAT IS TO SAY THERE'S A DOSE OF THERE'S A DEARTH OF QUALIFIED APPLICANTS WHO COME FROM MINORITY GROUPS. WHEN WE DID JUST AN EARLY VIEW TO UNDERSTAND WHAT WAS IMPACTING THIS FIRST GENERAL FINDING, WE DISCOVERED THAT THERE ARE IMPORTANT EDUCATIONAL DISPARITIES THAT TRULY MAY BE HARMING MILLIONS OF STUDENTS, AND IT IS ESPECIALLY ACUTE WHEN ONE LOOKS AT THE MINORITY AND THOSE STUDENTS FROM SOCIOECONOMICALLY DISADVANTAGED ENVIRONMENTS, AND ONE OF THE AREAS WHERE THIS IS MOST TELLING WAS MALDISTRIBUTION OF WELL TRAINED SKILLED SCIENCE TEACHERS TO TARGET THOSE COMMUNITIES WHERE BOTH THE NEED IS GREATER AND THE RETURN ON INVESTMENT WOULD BE GREATER, AND WE REALIZE THAT THIS LED TO A CYCLE OF LOWER ACADEMIC AND CAREER EXPECTATIONS FROM THOSE STATE YOUR NAMSAMESTUDENTS. I THINK WE WERE ALL STRUCK WHEN WE ACCEPTED TESTIMONY FROM VERY TALENTED AWARDED TEACHERS IN THE GREATER WASHINGTON, D.C. AREA WHO MADE IT VERY CLEAR TO US THAT FOR THEM TO UNIQUELY ENGAGE THE PARTICULAR STUDENTS ABOUT WHOM WE HAVE REFERENCED NOW, THEY WENT IN THEIR OWN POCKET ON THEIR OWN TIME ALL SCHOOL HOURS TO PROVIDE THE ENHANCEMENT EXPERIENCES THAT GAVE THOSE CHILDREN A DIFFERENT INSIGHT INTO A CAREER IN BIOMEDICAL SCIENCE. IN THE ABSENCE OF THAT KIND OF EXTRAORDINARY COMMITENT TO THE STUDENTS, WE DI COVERED THAT THERDISCOVERED THEREWAS A VERY, VERY CHALL ENGING DISTRIBUTION OF MOTIVATED SKILLED TEACHERS. THIS IS NOT AN INDICTMENT OF TEACHERS PER SE, BUT IT REFLECTS SOME OF THE CAN DIFFICULTIES OF WORKING WITHIN CERTAIN COMPONENTS OF THE PUBLIC EDUCATION SYSTEM. T'S WHY THE THIRD STATEMENT SAYS THAT THERE ARE ISSUES AT A BROADER LEVEL THAT ACTUALLY SHOULD BE PART OF A NATIONAL CONVERSATION THAT SHOULD INCLUDE NOT JUST THE NIH, BUT POLICY MAKERS, COMMUNITY LEADERS, POLITICIANS, AND ESPECIALLY FAMILIES. WE FOUND THERE WAS AN ABSENCE OF FAMILY INVOLVEMENT AS ANOTHER KEY CONSIDERATION IN SOME OF THESE GROUPS. SO THAT REALLY IS THE PREAM LEADING UP TO WHERE WE ARE, AND FOR A MOMENT, I WOULD LIKE TO BE CERTAIN THAT I HAVE EVERYONE'S ATTENTION, BECAUSE THIS REALLY IS THE MOST IMPORTANT THING I WILL TELL YOU ABOUT THE REPORT AND I HOPE THAT YOU TAKE THE TIME TO READ THE REPORT AT A MINIMUM, TO READ THE EXECUTIVE SUMMARY. IT'S A FIVE-PAGE EXECUTIVE SUMMARY. THREE OF THE PAGES ARE SCHEMATIC, TWO ARE NARRATIVE, THAT REALLY DOES GIVE YOU A FAIRLY GOOD CAPTURE OF 10 MONTHS OF OUR DISCUSSION THAT WE TRIED TO NARROW INTO SOMETHING VERY CRISP BE ZO THAT I SO THAT IT WOULD BE DIGESTIBLE, BUT FOR THIS ONE MOMENT I WANT YOUR UNDIVIDED ATTENTION. THIS IS THE GUIDING PRINCIPLE FOR OUR COLLEGE GROUP. THE PRECOLLEGE STEM ACTIVITIES OF THE NATIONAL INSTITUTE NATIONAL INSTITU TES OF HEALTH NEED A REJUVENATED INTEGRATED FOCUS ON BIOMEDICAL WORKFORCE PREPAREDNESS SPECIAL CONSIDERATIONS FOR UNDER ITREPRESENTED MINORITIES. I REALLY WANT TO PAUSE THERE TO MAKE CERTAIN THAT EVERYONE IS ABLE TO DIGEST THIS. WE'LL HAVE A Q AND A LATER, BUT I THINK IT'S WORTH TAKING THIS GUIDING PRINCIPLE IN. HAVING SAID THAT THEN, LET ME ASK YOU GO TO SLIDE 7. THIS IS OUR OVERARCHING RECOMMENDATION, AND I WOULD LIKE TO HAVE AS MUCH OF YOUR ATTENTION FOR THIS AS I JUST HAD FOR THE GUIDING PRINCIPLE. WE REALLY IT FELT LIKE THE BEST WAY TO DO THIS WASN'T TO MAKE SOME STATEMENT ABOUT A DRACONIAN CUT OR A NEW FUNDING INITIATIVE OR A NEW REQUIREMENT TO SEEK RESOURCES ELSEWHERE TO BRING TO THIS, BUT RATHER WE MADE A SINGLE OVERARCHING RECOMMENDATION TO LEAD ALL OF THE OTHERS, AND THAT IS THAT THE NIH, THE NATIONAL INSTITUTES OF HEALTH, NEEDS TO ESTABLISH A TRANSFORMATIVE BODY WITH STRONG GALVANIZING LEADERSHIP AND WITH REPRESENTATION OF ALL RELEVANT NATIONAL INSTITUTE OF HEALTH, ICs, INSTITUTES CENTERS AND OFFICES AND OTHER COMMITTED NON-NIH STAKEHOLDERS TO OVERSEE SEVERAL THINGS PERTINENT TO THE CHARGE. THE FIRST IS TO DEVELOP A UNIFORM REPORTING TEMPLATE FOR THE NIH SPONSORS PRECOLLEGE STEM PROGRAMS. YOU MAY HAVE HEARD NORM IN HIS OPENING STATEMENT SPEAK DIRECTLY TO THE NUMBER OF PROGRAMS OUTSIDE OF THE NIH, BUT AS WELL TO THE NUMBER OF PROGRAMS WITHIN THE NIH WHERE WE DON'T HAVE A CONNECTIVITY AND WE DON'T HAVE A UNIFORM REPORTING TEMPLA SO WE DON'T HAVE AN OPPORTUNITY TO UNDERSTAND WHAT IS THE DEFINITION OF SUCCESS, WHETHER IT BE AN NIH OR NON-NIH PRECOLLEGE STEM PROGRAM. THE SECOND THING THIS IT TRANSFORMATIVE BODY NEEDS TO DO IS TO CREATE AND MAINTAIN AN INVENTORY OF ALL PROGRAMS. IT TOOK US SOME TIME TO GET THIS INVENTORY PUT TOGETHER, BUT WE DID SUCH, BUT IT'S NOT A A STATIC INVENTORY. THERE'S A DIE NAM SISM TO THIS PROCESS THAT NEEDS TO BE RESPECTED AND A BODY NEEDS TO CONTINUE TO MONITOR AND UNDERSTAND THE INVENTORY OF PROGRAMS. THE THIRD FUNCTIONALITY IS TO UNDERSTAND HOW ONE CAN CAN FIND THE RIGHT OPERATIONAL STRATEGIES TO OPTIMIZE A FUNCTIONALITY TO ALL OF THESE CURRENT AND PLANNED PROGRAMS, AND THE FOURTH ONE IS THE COORDINATION OF THESE PROGRAMS. NOT BECAUSE WE'RE TRYING TO CUT ANY PROGRAMS, BUT WE'RE TRYING TO UNDERSTAND WHERE IS THERE SYNERGY WITH OTHER FEDERALLY SUPPORTED PRECOLLEGE STEM ACTIVITIES, HOW CAN PROGRAMS LET ME TEACH OTHERS TO HAVE MORE IMPACT, HOW CAN WE GET OPTICS ON ALL THE PROGRAMS AND UNDERSTAND WHAT NETWORKS ARE NATURALLY PRESENT IN OUR PRECOLLEGE ENGAGEMENT TOE. THEN WE ALL AGREE THAT NUMBER FIVE IS UNBELIEVABLY IMPORTANT. IF WE DON'T MEASURE IT, WE HAVEN'T DONE IT, AND WE HAVE TO COME UP WITH EVALUATIVE CRITERIA SO WE CAN UNDERSTAND THE SUCCESS OF THESE PROGRAMS. ARGUABLY, NIH IS INVESTING SIGNIFIANT DOLLARS ALREADY IN THIS SPACE EVEN THOUGH IT'S NOT A TOP TIER INITIATIVE OF THE NATIONAL INSTITUTES OF HEALTH, WE OUGHT KNOW BY A SET OF CRITERIA THAT CAN BE AGREED UPON AND THAT CAN BE INFORMED BY EXPERTS IN THE EVALUATION OF EDUCATIONAL PROGRAMMING WITHIN THE BROADER COMMUNITY, WHAT IS SUCCESSFUL, WHAT DEFINES SUCCESS, AND HOW CAN WE GO FORWARD WITH IT. WHAT I'VE SHARED WITH YOU ON SLIDES 6 AND 7 ARE CRITICALLY IMPORTANT. OUR GUIDING PRINCIPLE AND OUR OVERARCHING RECOMMENDATION. AND I HOPE YOU WILL TAKE SOME TIME TO DIGEST THAT. LET ME GET YOU TO DO A SLIGHT SHIFT IN THINKING NOW TO SOMETHING A BIT MORE OPERATIONAL. THAT IS TO LOOK AT THE STEPS WE THINK NIH SHOULD TAKE. SO UP UNTIL THIS TIME, I'VE OUTLINED TO YOU THE ORIGINAL CHARGE THAT WE WERE GIVEN AND THE ELEMENTS OF THAT CHARGE, I'VE TOLD YOU THAT WE'VE GONE THROUGH A LONG PROCESS AND HAVE DIGESTED ALL THE INFORMATION WE'VE GATHERED AND REPRESENTED IT IT IN A GUIDING PRINCIPLE, AND THEN I'VE GIVEN YOU OUR TOP TIER OVERARCHING RECOMMENDATION. NOW I WANT TO TALK OPERATIONALLY ABOUT STEPS THAT WE THINK THE NIH SHOULD TAKE TO SPECIF NOT ONLY ANSWER THE CHARGE BUT TO BE TRUE TO THE GUIDING PRINCIPLE AND TO WORK WITHIN THIS TRANSFORMATIVE BODY THAT WE THINK NEEDS TO BE DEVELOPED. THREE STEPS, AMOUNT, A, B AND C. STEP A, FOCUS PRECOLLEGE EFFORTS IN THE MOST PRESSING WOR WORKFORCE NEEDS. STEP B, COORDINATE AND CULTIVATE EFFECTIVE PROGRAMS AND APPROACHES AND STEP C, LEVERAGE STRENGTHS OF THE PUBLIC AND PRIVATE SECTORS. LET ME GO TO SLIDE 9. ONCE AGAIN I NEED YOUR ENGAGEMENT ON THIS. FOR THOSE THREE STEPS THAT I JUST GAVE YOU, FOCUS PRECOLLEGE EFFORTS ON THE MOST PRESSING WORKFORCE NEEDS, COORDINATE AND CULTIVATE EFFECTIVE PROGRAMS AND APPROACHES AND LEVERAGE OF THE PUBLIC AND PRIVATE SECTORS, I NOW SHARE WITH YOU ON SLIDE 9 THE SIX MOST IMPORTANT FINDINGS THAT HAVE EMERGED FROM THE WORK, THE RESEARCH, THE TESTIMONY, THE DISCUSSIONS AND DELIBERATIONS WE'VE HAD. I WOULD HIGHLIGHT BOLD FACE EACH FINDING, THEN AFTER THAT FINDING, I WILL SHARE WITH YOU ONE OR TWO DATA POINTS TO SUPPORT THAT FINDING AND THEN A SERIES OF RECOMMENDATIONS TO SPECIFICALLY SHOW HOW THE FINDING CAN BE ADDRESSED. SO FINDING NUMBER ONE, THERE ARE LIMITED OPPORTUNITIES FOR UNDER-REPRESENTED MINORITY AND LOW SES STUDENTS TO ENGAGE IN BIOMEDICAL SCIENCE EDUCATION. SLIDE 10 GIVES YOU THE SUBSTANCE OF THE DATA WHICH ALLOWS US TO MAKE THAT STATEMENT AS FINDING NUMBER ONE. THE FIRST, THE OVERALL MAKEUP OF THE WORKFORCE IS DECIDEDLY LACKING IN DIVERSITY, ESPECIALLY IN POSITIONS OF LEADERSHIP. NUMBER TWO, STEM ATTITUDES ARE POSITIVE AT A YOUNG AGE ACROSS GENERALLER DER AND RACIAL/ETHNIC GROUPS, THERE ARE MANY CHILDREN WHO PROFESS AN INTEREST IN A CAREER IN SCIENCE, PI PERCENTAGES, BUT IT'S WHAT HAPPENS ON THE BACK END OF THE PIPELINE THAT IS SO STRIKINGLY DIFFERENT. THAT'S WHY THE PARENTHETICAL PART OF THIS IS (BUT ACCESS AND PERFORMANCE GAPS BEGIN TO APPEAR IN ELEMENTARY SCHOOL. THEN FINDING NUMBER THREE, THERE IS A VERY STRONG NEED TO ENGAGE AND RETAIN UNDER-REPRESENTED AND LOW SES STUDENTS AND IMPROVE THEIR ACCESS TO EDUCATIONAL AND CAREER OPPORTUNITIES. THROUGH THE PROCESS, WE DISCOVERED SEVERAL EXEMPLARY PROGRAMS ONE IN WEST VIRGINIA AND ONE AT STANFORD WHERE THIS CAN OCCUR, SO HERE ARE THE RECOMMENDATIONS. THIS SHOULD BE SLIDE 11. THESE ARE THE RECOMMENDATIONS TO SUPPORT FINDING NUMBER ONE, THAT SPECIFICALLY ARTICULATES THE LIMITED OPPORTUNITIES FOR UNDER-REPRESENTED MINORITY AND LOW SES STUDENTS. BETTER TARGET NIH-FUNDED EDUCATION OUTREACHES -- OUTREACH TO STUDENTS FROM UNDER-REPRESENTED GROUPS AND THEIR TEACHERS. NUMBER TWO, PROMULGATE BEST PRACTICES OF EXEMPLAR PROGRAMS. I'VE TOLD YOU ABOUT TWO -- WITH A TRACK ROARED OF DIRECTING UNDER-REPRESENTED MINORITIES STUDENTS TOWARDS CAREERS IN BIOMEDICAL SCIENCE. THE NEXT RECOMMENDATION, UTILIZE DEMONSTRABLY SUCCESSFUL NIH ENRICHMENT PROGRAMS. WE'VE HIGHLIGHTED THE SUMMER INTERNSHIP PROGRAM BUT THAT'S NOT THE ONLY ONE. THERE'S OPPORTUNITIES TO ENHANCE DIVERSITY. THIS THITHIS ALSO MEANS WE ONCE AGAIN HAVE TO UNDERSTAND THE DEFINITION OF SUCCESS HERE. AND HAD THEN NUMBER FOUR, WE THINK THIS IS A GREAT OPPORTUNITY TO BUILD A PARALLEL CONCEPT THAT MIRRORS WHAT THE DIVERSITY SUBCOMMITTEE FOR THE ACD HAS DONE BY DEVELOPING THE MENTORING PROGRAM AND THE BUILD PROGRAM, SPECIFICALLY TO MONITOR THE OUTCOMES OF THE NASCENT UNDERGRADUATE PROGRAMS UNDERREPRESENTED MINORITY RECRUITMENT, MENTORING AND TRAINING, SPECIAL THE NRMN PROGRAM AND THE MENTORING PROGRAM AND THE BUILD PROGRAM, TO DETERMINE WHETHER WE CAN REPLICATE THOSE STRATEGIES BUT DEPLOY THEM AT THE MIDDLE AND HIGH SCHOOL LEVEL, AND AGAIN, INCLUDING THE TEACHERS. LET ME ASK YOU NOW GO TO SLIDE 12, AND WE WILL HAD NOW LOOK AT THE SECOND FINDING. I'I'VE TAKEN YOU THROUGH THE FIRST FINDING WITH WITH THE DATA POINTS AND THE RECOMMENDATIONS. THE SECOND FINDING, I THINK IS ALMOST EQUALLY AS IMPORTANT AS THE P FIRST FINDING BECAUSE IT GETS BACK SOME OF THE ORIGINAL CRITICISM WE FACE WHEN WE INITIALLY LAUNCHED THIS EFFORT. A BROADENING OF WORKFORCE CATEGORIES IS IMPORTANT TO CONVEY TO PRE-COLLEGE YOUTH WHO MIGHT CONSIDER CAREERS IN BIOMEDICINE. LET ME HAVE YOU GO TO SLIDE 13 NOW, AND LOOK AT WHAT WE'VE BEEN ABLE TO IDENTIFY. THERE IS NO CONSENSUS ON THE OPTIMAL SIZE OF THE BIOMEDICAL WORKFORCE. MANY JOB CATEGORIES ARE CONSTANTLY EMERGING. THERE'S A NEED TO CULTIVATE CROSS CAN DISCIPLINARY SCIENCE AND MATH OPPORTUNITIES FOR YOUNG PEOPLE TO BRING NEW CAPABILITIES. AND WITHOUT A BROADER CON CONCEPTUALIZATION OF THIS CROSS-DISCIPLINARY SCIENTIFIC NED AND A MORE ENCOMPASSING DEFINITION OF A CAREER IN BIOMEDICAL SCIENCE, IT IS FRANKLY DIFFICULT IF NOT IMPABL TO UNDERSTAND THE SIZE, QUALITY, OR NEEDS OF THE FUTURE WORKFORCE. SO IF YOU GO TO SLIDE 14, YOU CAN SEE THE TEMPLATE THAT WE DRAFTED AS A COMMITTEE TO SHOW THE EVOLUTION OF THE BIOMEDICAL WORKFORCE. TRADITIONALLY, WE'VE THOUGHT ABOUT PRINCIPAL INVESTIGATORS, CLINICIAN SCIENTISTS AND POSTDOCTORAL RESEARCHERS. MANY OF US ON THE PHONE AND AROUND THE TABLE TODAY FALL INTO ONE OF THESE THREE CATEGORIES. GOING FORWARD, THOUGH, THIS DEFINITION OF THE OF THE BIOMEDICAL WORKFORCE HAS TO BE MORE ENCOMPASSING. CLINICAL TRIAL COORDINATOR, GRANT -- AM I STILL ON? >> YES, YOU'RE DOING GREAT. >> OKAY, GREAT. COMPUTATIONAL BIOLOGISTS, SCIENCE POLICY ANALYSTS. YOU SEE, A NUMBER OF CAREER OPTIONS THAT NOW APPEAR IN THIS TEMPLATE THAT WE'RE BRINGING FORWARD THAT ARE NOT PART OF THE TRADITIONAL TEMPLATE, THIS NEEDS TO BE PROMULGATED AND MADE CLEAR TO OTHERS. SO IN SLIDE 15, YOU CAN SEE THE RECOMMENDATIONS. THERE AS YOU WOULD EXPECT NOW. EMPHASIZE THE WIDE RANGE OF CURRENT AND FUTURE CAREER O AVAILABLE TO STUDENTS. PROMOTE THIS CROSS DISCIPLINARY NATURE WE'VE BEEN TALKING ABOUT OF INNOVATIVE BIOMEDICAL SCIENCE WITHIWITH ANESPECIALLY SPECIFIC FOCUS ON BIOINFORMATICS. I HAD THE OCCASION TO VISIT WITH THE SENIOR FRAMINGHAM INVESTIGATOR OVER THE WEEKEND AT A CARDIOVASCULAR EDUCATIONAL CONFERENCE I IN NEW YORK, HE INDICATED TO ME THAL OF HIS POSTDOCS ARE NOT FROM THE TRADITIONAL SCIENCE DOMAIN, THEY ALL ARE COMING FROM COMPUTATIONAL BIOLOGY, BIOINFORMATICS, ANALYTICS. SO IT'S VERY CLEAR THAT IT THE LANDSCAPE HAS CHANGED AND WE NEED TO BE CERTAIN THAT STUDENTS UNDERSTAND THIS CHANGING LANDSCAPE. THE THIRD PART ABOUT THIS IS OUR STEM EDUCATION PROGRAM SHOULD BE INFORMED BY THE WORK OF THE NIH DIVISION OF BIOMEDICAL RESEARCH PROGRAMS SO THAT WE CAN COLLABORATE, WE CAN UNDERSTAND THE COMPOSITION OF THE WORKFORCE, PROJECT FUTURE WORKFORCE NEEDS, AND IDENTIFYING THOSE SKILLS, THIS SHOULD BE FOSTERED IN K-12 EDUCATION SETTINGS. I WOULD ARGUE THAT THESE FIRST TWO FINDINGS, THE ABSENCE OF DIVERSITY AND THE NEED TO REDEFINE WHAT CONSTITUTES A CAREER IN THE BIOMEDICAL WORKFORCE ARE PARAMOUNT IN OUR INITIATIVE AND WOULD FUNDAMENTALLY CHANGE THE LANDSCAPE IF WE COULD ACCOMPLISH THIS SUCCESSFULLY. LET ME GO ON TO SOMETHING ELSE THAT I THINK IS ALSO SO IMPORTANT THAT WE ACTUALLY FOUND IT TO BE RIVETTING. WHEN WE COMPLETED OUR INVENTORY, WE DISCOVERED THAT THE NATIONAL INSTITUTES OF HEALTH HAS A LARGE PORTFOLIO OF PRECOLLEGE STEM ACTIVITIES, SO MUCH SO THAT WE NEED TO UNDERSTAND THE CHARACTERISTICS OF ALL THOSE PROGRAMS AND LOOK FOR AREAS WHERE WE CAN STREAMLINE. STREAMLINE DOESN'T MEAN CUT, BUT WHERE WE CAN BRING PROGRAMS TOGETHER, ENHANCE EFFECTIVENESS AND IMPROVE COORDINATION. IN KEEPING WITH THE MODEL, LET ME HAVE YOU GO TO SLIDE 17 THAT IDENTIFIES WHAT WE ARE DESCRIBING. THAT IS, NIH ALREADY SUPPORTS A LARGE NUMBER OF STEM PROGRAMS TARGETED PRECOLLEGE STUDENTS AND TEACHERS LIKE THE SUMMER RESEARCH PROGRAM, BUT THESE PROGRAMS ARE FOR THE MOST PART AD HOC NOT CONNECTED WITH EACH OTHER AND NOT COORDINATED. I DID NOT SAY THAT THESE PROGRAMS ARE INEFFECTIVE. WE DON'T KNOW THAT AND WE'RE NOT INDICTING ANY PROGRAM. WE'RE JUST SIMPLY SAYING THAT THERE'S SO MANY EFFORTS THAT ARE STANDALONE THAT THIS IS NOT A PROBLEM, IT IS AN OPPORTUNITY. AND WE CAN ADDRESS THIS OPPORTUNITY BY BRINGING TOGETHER A CENTRAL REPORTING STRUCTURE AND BUILDING AN INFRASTRUCTURE THAT BEARS ACCOUNTABILITY AS YOU SEE IN THE SECOND FINDING. SO LET ME HAVE YOU 50 TO SLIDE 18. I THINK THIS IS WHERE THE WORD RIVETTING IS JUSTLY DESERVED. IF YOU LOOK AT THE INVENTORY OF THE NATIONAL INSTITUTE OF HEALTH'S PRECOLLEGE ACTIVITIES, LU SEE THAT WE WERE ABLE TO AGGREGATE 246 PRECOLLE STEM ACTIVITIES IN THIS INVENTORY. A NUMBER THAT FAR EXCEEDED ANY THAT WE THOUGHT WE WOULD FIND. 117 GRANT AWARDS, 35 INTERNSHIP PROGRAMS, 19 CURRICULUM IS IS SUPPLEMENTS, 66 TEACHER ACTIVITIES. THIS REFLECTS DIFFERENT NUMBERS FOR WHAT CONSTITUTES A PROGRAM, REFLECTS INPUT FROM DIFFERENT INSTITUTE CENTERS, BUT NEVERTHELESS, THE NUMBER APPROXIMATES 250 PROGRAMS. IF YOU GO TO SLIDE 19, YOU CAN SEE SOMETHING IN A GRAPHICAL DEPICTION WHICH FIRST OF ALL SHOWS YOU THE VERY PROFILE OF THESE PROGRAMS, AND AGAIN, IT'S QUITE EVIDENT THAT UNFORTUNATELY THERE ISN'T A VORTEX IN THE MIDDLE, THERE ISN'T A CENTER WHERE ALL OF THESE DIFFERENT PROGRAMS SUPPORT. NEARLY HALF ARE EXTRAMURAL GRANT AWARDS, 35% ARE RESOURCED DIFFERENTLY, 10% ARE INTRAMURAL PROGRAMS, 7% ARE EXHIBIT PROGRAMS. THIS IS THE KIND OF PROFILE WE SEE, BUT AGAIN, WE'RE LOOKING AT THIS AS AN OPPORTUNITY, SO IN SLIDE 20, WE'RE MAKING IT VERY CLEAR WHAT WE THINK THE RECOMMENDATIONS SHOULD BE. IN OUR OVERARCHING RECOMMENDATION, WE THINK THIS IS ONE OF THE BIG TASKS. THE TRANSFORMATIVE BODY TO WHICH WE SPOKE SHOULD MAKE CERTAIN THAT THE PROGRAMS THAT ALREADY EXIST MAKE A VERY SINCERE EFFORT OF OUTREACH TO UNDERREPRESENTED POPULATIONS. WE NEED TO WORK TOGETHER AND COLLABORATIVELY TO IDENTIFY BEST PRACTICES AND EXPAND THE EXEMPLAR PROGRAMS. WE NEED TO IDENTIFY RESOURCES TO BE PROVIDED TO THOSE ENGAGED IN TEACHING OR MENTORING THE PLEA COLLEGE STUDENTS, AND WE NEED TO PROVIDE AN INFRASTRUCTURE AND PROCESS TO ENABLE CURRICULUM DEVELOPERS TO IDENTIFY AND COLLABORATE WITH SUBJECT MATTER EXPERTS AT NIH. WE ARE THE TRAINING LABORATORY FOR STEM PROGRAMS OUTSIDE THE NIH AND WE SHOULD BE ABLE TO COME FORWARD WITH BEST PRACTICES, WE SHOULD BE ABLE TO IDENTIFY EXEMPLAR PROGRAM, WE SHOULD BE ABLE TO REACH OUT TO OTHERS INVOLVED IN TEACHING AND MENTORING AND WE SHOULD BE THE ONES TO HELP POPULATE NEW IDEAS. WE BELIEVE THAT'S A MUST. LET ME HAVE YOU GO ON TO FINDING NUMBER FOUR. THIS IS A BIT DISHEARTENING, BUT IT IS CORRECT. THERE ARE NO STANDARD MEASURES OF SUCCESS FOR THE EXISTING NIH PRECOLLEGE STEM ACTIVITIES. IF WE ARE THE INCUBATOR OF THE RT WAY TO DO THIS, THEN WE HAVE NO SET STANDARD NO, BAROMETER THAT TELLS US WE'VE COME UP WITH THE RIGHT IDEA. WE BELIEVE A MORE STANDARDIZED PERHAPS EVEN RIGOROUS EVALUATION PROCESS MAY BE FOR THE GOOD, NOT AS MORE BUREAUCRACY OR MORE BURDEN, BUT IT MAY STRENGTHEN THE ACTIVITIES AND PRODUCE NEW BEST PRACTICES. LET ME SHOW YOU THE DATA THAT ALLOWS US TO SPEAK WITH SUCH VO VORASCITY ABOUT THIS STATEMENT OR THIS FINDING. NUMBER FOUR, FOR THESE NEARLY 250 PROGRAMS, 128 PROVIDED PROGRESS REPORT NOT POPULATED THE SAME FROM ONE REPORT TO THE NEXT, 82 PROVIDE MILESTONE REPORTS, 96 UNDERGO SOME INDEPENDENT EVALUATION PROCESS, AND 48 HAVE A PROCESS THAT JUST SIMPLY FALLS INTO A CATEGORY OF "OTHER," AND OBVIOUSLY SOME OF THESE HAVE MULTIPLE PROCESSES. IT'S VERY DID DIFFICULT TO GO THROUGH A PROCESS LIKE THIS AND UNDERSTAND WHICH ONES TRULY HAVE BEEN SUCCESSFUL WITHOUT HAVING SOMETHING THAT IS RECENTLY STANDARD. PASSING AROUND THE TABLE THERE IS A COPY OF A PUBLIC COMMENT WHICH WE GREATLY RESPECT, AND ONE OF THE STATEMENTS MADE IN THAT PUBLIC COMMENT IS THAT THERE IS A RISK OF TRYING TO CENTRALIZE THIS PROCESS AND COME UP WITH STANDARDIZATION OF THESE STEM PRAP PRAMS ANSTEM PROGRAMS AND WE UND ERSTAND THE RISK BUT WE ALSO UNDERSTAND THE NEED FOR SOME FLOOR THAT UNDERSTANDS HOW THE PROGRAMS ARE TODAY, HOW THEY'RE MOVING FORWARD, AND WE UNDERSTAND THE OVERARCHING PICTURE, STRAIGHTFORWARD MEASURES AND METRICS THAT WE CAN BEGIN TO LOOK AT AND AS WELL THE MATTERS OF PROCESS THAT WORKING WITH EXPERTS IN EVALUATION OF EDUCATIONAL STANDARD, WE CAN COME UP WITH AND, AGAIN, NIH CAN HAVE ITS RIGHTFUL PLACE AS A LEADER IN THIS PROCESS. LET ME THEN TAKE YOU TO SLIDE 23. THAT IS YET ANOTHER STATEMENT ABOUT OUR FINDINGS, THAT THIS VARIETY OF EVALUATIVE METHODS MAKES IT VERY DIFFICULT TO SPEAK WITH ONE VOICE ABOUT WHAT'S GOING ON. THERE'S VERY LITTLE EVIDENCE WE HAVE ON EITHER THE PROGRAMS OR ATE PROACHS THAT IT ACTUALLY HAS IMPROVED THE OUTCOMES, PARTICULARLY FOR TEACHERS BUT ALSO FOR STUDENTS, AND THE DILEMMA. AND THIS IS WHY WE HAVE SOME CONVICTION THAT THIS IS SO IMPORTANT, IS THAT WITHOUT AN EVIDENCE BASE FOR WHAT WORKS, IT IS IMPOSSIBLE TO PRECISELY DEFINE THE ATTRIBUTES OF WHAT CONSTITUTES AN EFFECTIVE STEM PROGRAM. BUT AGAIN, THIS THIS IS AN OPPORTUNITY, THIS REPORT IS NOT IN THE NEGATIVE, IT'S IN THE POSITIVE. HERE IS SOMETHING WE'VE DISCOVERED THAT REPRESENTS A TARGET FOR FUTURE NIH ACTIVITIES SO WE CAN CRISPLY IDENTIFY WHAT IS AN EFFECTIVE STEM PROGRAM. SO IN KEEPING WITH THE FLOW OF THE INFORMATION, LET'S GO TO THE RECOMMENDATIONS AND THIS IS ON SLIDE 24, AND THESE ARE THE RECOMMENDATIONS TO PROVIDE A DIFFERENT EVALUATIVE PROCESS FOR THE CURRENT STEM ACTIVITIES. NUMBER ONE, IDENTIFY AND TRACK THE DEVELOPMENT OF STEM EDUCATION BEST PRACTICES AND EVALUATION STANDARDS FROM THE BROADER COMMUNITY. NUMBER TWO, DEFINE SUCCESSFUL OUTCOME. WHETHER IT'S CAREERS, WHETHER IT'S SOME OTHER METRIC, AND WHEN WE DEFINE CAREERS, MAKE THAT DEFINITION BROAD AS WE'VE TRIED TO SUGGEST IT SHOULD BECOME, AND THEN IMPORTANTLY, WITH WHATEVER EFFORT IS REQUIRED, DEVELOP THE METRICS NEEDED TO EVALUATE THE EFFECTIVENESS OF THE NIH STEM PROGRAMS. IT'S EASILY IN THE EIGHT-DIGIT RANGE, WE SHOULD HAVE A BETTER HANDLE ON WHAT CONSTITUTES SUCCESS HERE. ADDITIONAL RECOMMENDATIONS ARE ON SLIDE 25. APPLY SYSTEMATIC AND COMPARABLY VALUATION PRACTICES FOR NIH'S PRECOLLEGE PROGRAMS. AS THE EVIDENCE BASE FOR PRECOLLEGE STEM EDUCATION GROWS, DETERMINE THE FEASIBILITY OF EXPANDING EVALUATION METRICS TO INCLUDE MEASURES OF LONG TERM PROGRAM EFFECTIVENESS. IF TRUTH WEE HAD SOME COME TO US -- THEY WERE POLITICALLY SELF-SERVING. SO THIS IS A FIELD THAT NEEDS A LOT MORE SOPHISTICATION BUT IT CAN BE DONE. THEN WORK WITH OTHER AGENCIES AND ORGANIZATIONS TO IMPROVE THE COLLECTION OF LONGITUDINAL STUDENT LEVEL DATA ESPECIALLY AS IT RELATES TO THE PRECOLLEGE STUDENT'S EXPOSURE TO BIOMEDICAL AND HUMAN HEALTH LEARNING EXPERIENCES AND TRACK IT WITH THEIR EVENTUAL CAREER TRAJECTORIES AND THAT WOULD BE A GOOD STEP FORWARD. SLIDE 26, THIS IS FINDING NUMBER FIVE. THIS ONE IS NOT UNEXPECTED. THAT TO SAY THERE IS UNTAPPED POTENTIAL IN NIH'S RESEARCH COMMUNITY. LET ME HAVE YOU GO TO THE FIND THAT SUPPORTS THIS, AND THAT'S ON SLIDE 27. LEVERAGING NIH'S EXISTING NETWORK OF FUNDED RESEARCH CENTERS OFFERS AN EFFECTIVE IT AND COST-EFFICIENT OPPORTUNITY TO INCREASE THE IMPACT OF THE NIH IN PRECOLLEGE E IN BIOMEDICAL SCIENCE. NIH SUPPORTS MORE THAN 300,000 RESEARCH PERSONNEL AT OVER 2500 UNIVERSITIES AND RESEARCH INSTITUTIONS AS WELL AS 6,000 SCIENTIST ITS AND CLINICIANS IN THE INTRAMURAL PROGRAM. I RECENTLY HAD AN OPPORTUNITY TO WORK ON ANOTHER LARGE SCALE INITIATIVE ON BEHALF OF THE AMERICAN HEART ASSOCIATION. AND AS WE WERE BRINGING TOGETHER COMMENTARY FROM OUTSIDE COULD BE SUL TANTS AND OTHERS THAT HAD HAD AN EXPERIENCE SIMILAR TO OURS BUT ADDRESSING A DIFFERENT DOMAIN, WHAT WE DISCOVERED IS THAT FOR CHANGE TO HAPPEN, THERE NEEDS TO BE SOME LIGHTNING ROD, SOME COMING TOGETHER, SOME EXPERIENCE THAT GETS EVERYBODY HUDDLED UP TO HAVE CERTAIN CONVERSATIONS. IF YOU WILL, THERE NEEDS TO BE A CAMPFIRE. NIH IS THE CAMPFIRE FOR THE ENTIRE SCIENCE COMMUNITY. THERE IS NO REASON WHY WE CAN'T SPEARHEAD A CONVERSATION LIKE THIS AMONGST THESE 6,000 SCIENTISTS, THESE 2,500 UNIVERSITIES, AND THESE 300,000 RESEARCH PERSONNEL TO SAY YOU KNOW WHAT, THESE ISSUES ARE IMPORTANT, WE NEED TO EXPAND THE DEFINITION OF BIOMEDICAL WORKFORCE, WE MEADE TO EP HANS THE DIVERSITY, WE NEED TO MAKE SURE THAT ALL PERSONS ENTERING THESE CAREERS ARE PREPARED TO DO SUCH. SO IT IF YOU CONTINUE TO LOOK ON SLIDE 28 AT WHAT SUPPORTS THESE STATEMENTS, A NUMBER OF NATIONAL INSTITUTENATIONALINSTITUTES OF HEALTH FUND ED, DEVOTING TIME AND -- CAN WE LEARN SOMETHING FROM THEIR EXPERIENCES. CAN WE IDENTIFY THE EFFECTIVE SCALE OF PROGRAMS AT U.S. UNIVERSITIES THAT REALLY CAN BECOME THE EXEMPLAR PROGRAMS. WE DON'T HARDLY KNOW ALL OF THEM NOW, BUT CAN WE FIND A WAY TO TAP INTO WHAT'S HAPPENING OUTSIDE OF THE NIH AND OUR SUPPORTED INSTITUTIONS, AND WHAT CAN WE DO, AND THIS IS REALLY A KEY CONSIDERATION. HOW CAN WE GET THAT CONVERSATION GOING, WHERE WE CAN CHANGE THE CULTURE OF THE RESEARCH COMMUNITY TO UNDERSTAND THAT AT THE THRESHOLD OF PRECOLLEGE ENGAGEMENT, IT'S IMPORTANT AND WE ALL NEED TO STEP UP AND MAKE A DIFFERENCE THERE. SO ON SLIDE 29, YOU CAN SEE OUR RECOMMENDATIONS, INCREASE THE IMPACT AND REACH A PRECOLLEGE STEM EDUCATION EFFORT BY LEVERAGING OUR OWN INFRASTRUCTURE, THIS INCREDIBLE NETWORK THAT WE'VE ALREADY BUILT, GETTING THAT CONVERSATION EMBEDDED IN THE MINDSET OF EVERYBODY INVOLVED. THEN ENCOURAGE AND INTERSENT ADVISE STEM OUTREACH BY OFFERING SUPPLEMENTAL FUNDING WHICH WOULD NOT NEED TO BE ON A LARGE SCALE IN TERMS OF AMOUNTS BUT IS IN THE CENTER TO DO THE THINGS NECESSARY FOR OUTREACH, WHETHER IT'S SUMMER INTERNIPS, AGAIN FOR ALL STUDENTS, SEMINARS, SCIENCE FAIRS FOR ALL STUDENTS, HANDS-ON SCIENCE EXPERIENCES, WHEN YOU LISTEN TO THE SCIENCE TEACHERS WHO CAME TO TESTIFY BEFORE OUR COMUT TH COMMITTEE, WHAT I WALKED AWAY WITH WAS THAT EVERY1100% WERE DEAD ON PASSIONATE ABOUT THEIR KIDS, THEY WANTED THEIR KIDS TO BE SUCCESSFUL, AND THEY ALL SAID IT'S WHEN WE GET THEM TO DO SCIENCE THAT THEY GET TURNED ON. IT'S NOT JUST STUDYING AND TAKING THE TEST. IT'S WHEN THEY GET TO DO SCIENCE. THE NIH, HOW CAN YOU HELP US HAVE MORE MOMENTS FOR OUR STUDENTS SO THEY CAN SEE THAT SCIENCE IS FUN. BUT THAT WAS PRETTY COMPELLING. ON SLIDE 30, YOU'LL SEE WE WANT TO COMMUNICATE THE IMPORTANCE OF STUDENT AND TEACHER ENGAGEMENT. I'D LIKE TO GO TO THE END NOW AND FOCUS ON THE LAST FINDING. THERE ARE MANY OPPORTUNITIES TO PARTNER WITH OTHER ENTITIES COMMITTED TO PRECOLLEGE STEM OUTREACH. THE FINDINGS ARE AS YOU MIGHT IMAGINE, WE KNOW THAT THE DCHT EDUCATION IS DID DEEPLY COMMITTED TO THIS, THE NATIONAL SCIENCE FOUNDATION IS DEEPLY COMMITTED TO THIS. THERE ARE A NUMBER OF NON-GOVERNMENT ORGANIZATIONS, SOME OF WHICH ARE IN THE PHARMACEUTICAL INDUSTRY AND ARE QUITE ROBUST, IN FACT. THERE ARE OPPORTUNITIES THROUGH OTHER NOT FOR PROFITS THAT HAVE ALREADY TRIED TO NETWORK TO COLLABORATE TO BRING PEOPLE TOGETHER IN A MATRIX THAT SAYS ALL OF US CARE ABOUT STEM EDUCATION. BUT THE NATIONAL INSTITUTE OF HEALTH REALLY HAS THE -- WE REALLY HAVE THE STAMP OF AUTHENTICITY THAT CAN GET MORE PEOPLE AROUND THE TABLE TO HAVE MORE OF THESE CONVERSATIONS, TO LEVERAGE AS SUCH, AND TO LEVERAGE THE DIRECTION. SO SLIDE 33, YOU CAN SEE THAT WE'RE SPECIFICALLY ARTICULATING COSTEM MADE UP OF 14 FEDERAL ENTITIES, ADDRESSING THE FIVE NATIONAL GOALS. WE HAVE AN OPPORTUNITY TO BE AMONGST THAT GROUP TO REALLY HELP MAKE A BIG DIFFERENCE. SO WHAT ARE OUR RECOMMENDATIONS? SLIDE 34 SHOWS WE NEED TO LOOK FOR THE OPPORTUNITIES TO PROVIDE EXPERTISE AND GUIDANCE TO PROVIDE PRIVATE AND NOT FOR PROFIT ORGANIZATIONS THAT SUPPORT THIS INITIATIVE AND WE NEED TO PAY CLOSE ATTENTION TO THE ACTIVITIES OF COSTEM AND PARTICULARLY THE GROUPS WORKING O P-12 STEM INSTRUCTION AND HOW WE CAN ADDRESS THE DIVERSITY QUESTION THAT IS SO IMPORTANT TO US. LEVERAGE OUR EXPERTISE, TO PROVIDE OUR EXPERTISE, AND TO PARTNER WITH THESE ORGANIZATIONS THAT ARE LIKE MINDED IN THEIR APPROACH. ON SLIDE 36 THEN, I'M GOING BACK TO THE ENTIRETY OF OUR FINDINGS AND I WANT TO TAKE A MOMENT HERE TO BE CERTAIN THAT I'V I'VE RECAPITULATED WHAT WE'VE ACTUALLY DONE. WHAT IS HAPPENING IN THE SPACE UNIQUE TO THE NATIONAL INSTITUTES OF HEALTH BY VIRTUE OF INVESTMENTS THAT ALREADY EXIST OR BY VIRTUE OF THE MISSION OF THE NATIONAL INSTITUTES OF HEALTH TO IDENTIFY THE STATUS OF K-12 STEM EDUCATION AND PREPAREDNESS FOR BIOMEDICAL CAREERS. WE GAVE YOU A GUIDING PRINCIPLE THAT WE CAN DISCOVERED THAT THERE WAS A VERY REAL NEED TO DO THIS. WITH THE UNIQUE FOCUS ON THE ABSENCE OF DIVERSITY. WE GAVE YOU A SINGLE OVERARCHING RECOMMENDATION THAT SOME TRANSFORMATIVE BODY AND WE WILLINGLY PROVIDE THE LICENSE TO CONSTRUCT THAT BODY AS THE DIRECTOR AND THE DIRECTOR'S OFFICE WOULD SEE FIT TO FULFILL A NUMBER OF TASKS. I TOLD THERE YOU WERE THREE STEPS THAT NEED TO BE FOLLOWED. I'VE SHARED WITH YOU TODAY THERE WERE SIX FINDINGS THAT CONSTITUTED THE RECORD, AND FOR EACH FINDING, I'VE GIVEN YOU THE DATASET TO SUPPORT THIS FOR THE MOST PART QUALITATIVE, THE ANALYTICS ARE IN THE REPORT, AND THEN WE'VE GIVEN YOU THE SPECIFIC RECOMMENDATION FOR EACH FINDING, ALL OF WHICH IS INTENDED TO UPLOAD TOWARDS THAT GUIDING PRINCIPLE OF ADDRESSING THE LACK OF PREPAREDNESS WE'VE IDENTIFIED FOR CAREERS IN BIOMEDICAL SCIENCE, IT IN PART BECAUSE THE DEFINITION OF THE BIOMEDICAL WORKFOE NEEDS TO BE EXPANDED, AND AGAIN THE NECESSITY TO HAVE UNIQUE FOCUS ON DIVERSITY. SO THESE ARE THE SIX FINDINGS. THE LIMITED OPPORTUNITIES FOR UNDERREPRESENTED YOUTH, A BROADENING OF THE WORKFORCE CATEGORIES, AN ACKNOWLEDGMENT THAT WE HAVE A LARGE PORTFOLIO ALREADY WITHIN THE NIH ADDRESSING PRECOLLEGE STEM ACTIVITIES, BUT NOT A GOOD WAY TO COORDINATE THAT EFFORT. WE'VE IDENTIFIED THAT WE'RE ABSENT AT PRESENT STANDARD MEASUREMENT MEASURES THE SUCCESS, WE CAN USE THIS AS AN OPPORTUNITY TO INTRODUCE THOSE MEASUREMENTS AND IDENTIFY THE EXEMPLARY PROGRAMS THAT IDENTIFY AND PROVIDE NEW BEST PRACTICES. WE'VE SUGGESTED TO YOU THAT THERE IS SOMETHING TO BE SAID ABOUT THE LEVERAGE, THE IMPERMATURE THE OF THE GRAVITAS OF THE NIH THAT WE CHANGE THE CONVERSATION AND HOPEFULLY LEAD TOWARDS CHANGING THE CULTURE SO WE'RE SENSITIVE TO THE NEXT GENERATION. AND WE'VE ACKNOWLEDGED THAT THERE'S MANY PARTNERS IN THIS SPACE, PARTNERS THAT HAVE A BIG INFLUENCE, AND WE CAN WORK WITH THEM SO WE CAN REALLY MAKE THIS PART OF A MATH CONVERSATION. SO AT THIS POINT IN TIME, I THINK I'VE LEFT ENOUGH TIME AS I READ THE CALENDAR FOR HOPEFULLY WHAT WILL BE A GOOD DISCUSSION, AND THEN WITH NORM'S LEADERSHIP, WE CAN GET SOME DIRECTIONS FROM YOU WITH REGARDS TO A VOTE. THANK YOU NOT ONLY FOR INDULGING THIS REPORT, BUT THANK YOU FOR GIVING US THE OPPORTUNITY TO DO THIS WORK 10 MONTHS AGO. IT'S BEEN A GREAT JOURNEY FOR ALL OF US INVOLVED, AND HOPEFULLY WE'VE LEARNED SOMETHING, AND WE'VE BROUGHT SOMETHING UNIQUELY IMPORTANT FORWARD TO THE SMRB. THANK YOU. >> CLYDE, THANK YOU FOR THAT VERY COHERENT AND VERY SUCCINCT REPORT. IT REALLY WAS SUPERB. THANK YOU FOR YOUR LEADERSHIP OF THIS EFFORT. I JUST MIGHT ADD A PERSONAL FOOTNOTE THAT AS WE WENT THROUGH THIS, AS CLYDE SAID, THE MESSAGE THAT KEPT COMING UP OVER AND OVER WAS THE ABSENCE OF PARTICIPANTS FROM SOCIOECONOMICALLY DISADVANTAGED GROUPS, FROM MINORITY GROUPS, A HUGE BODY OF POTENTIAL TALENT THAT IS BASICALLY ABSENT TODAY. THAT WAS THE THING THAT KEPT STRIKING US OVER AND OVER, SO IT WAS A PRINCIPAL THRUST OF OUR WORK. AT HAD THIS POINT, IT'S APPROPRIATE TO TAKE COMMENTS FROM THE PUBLIC. YOU HAVE BEFORE YOU AN EMAIL FROM ONE INDIVIDUAL WHICH I THINK EVERYBODY'S HAD THE CHANCE TO READ. CLYDE ADDRESSED IT SO WE CAN TAKE IT FURTHER DURING THE DISCUSSION PERIOD IF YOU WANT, BUT I DO WANT TO CALL YOUR ATTENTION TO IT. ARE THERE ANY MEMBERS OF THE PUBLIC WHO WOULD LIKE TO MAKE ANY COMMENTS ON THIS REPORT? OKAY. HEARING NONE, I THINK IT'S APPROPRIATE FOR US TO, CLYDE, LET YOU KIND OF LEAD US IN THE DISCUSSION OF THE RECOMMENDATIONS AND FINDINGS OF THE PEBS WORKING GROUP, AND AFTER EVERYBODY AT THE TABLE HAS HAD A CHANCE TO MAKE WHATEVER COMMENTS YOU'D LIKE TO MAKE, WE HAVE COMPLIED WITH THE FIVE VOTE RULE AS I SAID THIS MORNING, AND SO ABSENT SOME MAJOR ISSUE THAT ARISES, WE'LL BE PREPARED TO VOTE ON IT. SO CLYDE, I KNOW IT'S HARD FOR YOU TO DO THIS AT A DISTANCE, BUT MAYBE WHAT I SHOULD DO IS CALL ON PEOPLE, THEN LET YOU ANSWER QUESTIONS. IS THAT SUITABLE, CLYDE? >> SURE. I AM NOW LOOKING AT THE VIDEO FEED SO I'M WAVING AT YOU RIGHT NOW. >> WHERE IS CLYDE? I DON'T SEE CLYDE. OKAY, CLYDE. GREAT. WE DON'T SEE YOU, BUT SINCE YOU SEE US, WHY DON'T YOU JUST TAKE OVER AT THIS POINT. >> GREAT. LET ME JUST OPEN HAD THIS UP FOR GENERAL COMMENTARY AT PRESENT. I SEE YOU LOOKING AROUND. HOW ABOUT THIS -- >> I HAVE ONE. A LOT SEEMS TO HINGE ON THE TRANSFORMATIVE BODY. I HAVE THE SCIENCE FICTION VIEW OF THIS THING, BUT I THINK I KNOW WHAT YOU MEAN BY IT. SO WHERE DOES THE AUTHORITY COME FROM, WHERE WILL ITS TEETH COME FROM TO MOVE SOME OF THIS FROM THE ELOQUENT DESCRIPTION THAT YOU'VE ALL PUT TOGETHER AND YOU ARTICULATED OVER THE LAST 40 MINUTES OR SO, HOW DOES THAT -- HOW DO YOU GO FROM THIS IN A REPORT, I'M ACTUALLY A NON-VOTING MEMBER SO I WON'T BE VOTING TODAY, BUT THOSE OF YOU THAT HAD VOTE ON IT, AND WHAT HAPPENS? HOW DOES THAT TRANSFORMATIVE BODY HAVE SOME TEETH? >> SO MICHAEL, I THINK THAT'S YOUR COMMENT CAN, AND I WILL SPEAK TO THIS DIRECTLY AND TELL YOU THAT THERE'S PRECEDENT HERE. WHEN THE ADVISORY COMMITTEE TO THE DIRECTOR IN THE PAST HAS LAUNCH OFFED INITIATIVES TO OORT LOOK AT THE DIVERSITY ISSUE, I WAS A PART OF THAT ACTIVITY, OR SEVERAL OTHERS THAT LOOKED AT THE WAY IN WHICH WE ARE MENTORING EARLY SCIENTISTS' CAREERS, WE'VE SEEN THE ABILITY TO DO TRANSFORMATIVE WORK, WE'VE SEEN THE AIBLGHT TO TAKE A NEW DIRECTION. I THINK THAT DR. COLLINS HAS USED HIS AUTHORITY VERY WISELY, AND WHEN HE HAS PLACED HIS STAM OF AUTHENTICATION ON A NEW INITIATIVE, THINK THE INSTITUTE DIRECTORS HAVE RESPONDED AND I THINK THE EXTERNAL COMMUNITY HAS FOLLOWED SUIT. FOR SOMETHING LIKE THIS, THOUGH, MICHAEL, THAT REALLY DOES AT ITS CORE INVOLVE CULTURE CHANGE, EVERY TIME YOU WANT CULTURE CHANGE, IT HAS TO START AT THE VERY TOP OF. SO WHETHER THAT'S OUR COMMITTEE UNDER NORM'S LEADERSHIP OR THE ACD OR AUDIENCE TO DIRECTORS, THERE HAS TO BE A WILLINGNESS OF EVERYONE WITH ALREADY EED AUTHORITY TO SAY THIS IS IMPORTANT AND WE NEED TO DO IT. YOUR COMMENT ABOUT SCIENCE FICTION AND IMAGES THAT THIS TRANSFORMATIVE BODY MIGHT COME UP WITH ARE KIND OF KEY. THEY RESONATE WITH ME. WE MAY NEED SOMETHING LIKE THE TRANSFORMERS. I'M NOT SURE IF WE NEED AN ACTION HERO OR NOT, BUT WE DO NEED SOMETHING VERY DIFFERENT THAN WE HAD BEFORE. WE WERE VERY RELUCTANT TO SAY WE WANT A COMMITTEE. THAT DIDN'T SEEM TO BE SUFFICIENT. BUT WE ALSO UNDERSTOOD THAT OTHER MODELS HIKE THIS THINK ABOUT THE NIH RESEARCH COLLABORATORY, WHICH I THINK IS SE VUK SES FULL, MAY NOT EXACTLY BE THE RIGHT TEMPLATE AS WELL, BUT SOMETHING BETWEEN THAT AND A COMMITTEE IS WHAT'S NEEDED HERE, WHERE WE HAVE DEEP INVESTMENT OF THE PEOPLE INVOLVED WITH MULTIPLE SKILL SETS REPRESENTED, BUT YOU THINK TO YOUR POINT OF WHERE DOES THE AUTHORITY RESIDE, THE AUTHORITY BEGAN WITH THE CHARGE THAT WE ACCEPTED TO DO THIS. IF THE SMRB APPROVES IT, THE AUTHORITY WILL GO BACK TO THE DIRECTOR, AND I BELIEVE ONCE THIS IS ENDORSED BY THE DIRECTOR, EVEN WITH THE MODEST AMOUNT OF RESOURCES, THAT WILL GET THE DISCUSSION GOING FURTHER ALONG THE PATH THAT WE BELIEVE WE'VE IDENTIFIED AS ONE THAT COULD LEAD TO A CULTURE SHIFT AND A CHANGE IN A BIOMEDICAL WORKFORCE. BUT THANK YOU, MICHAEL. >> SO I'M NOT INTO SCIENCE FICTION, BUT I DO THINK AND I WOULD UNDERSCORE WHAT CLYDE TALKED ABOUT, THAT IS THAT THERE ARE CLEARLY ACTIONABLE ITEMS HERE. THERE'S A CLEAR IT -- IT WAS CLEAR I THINK TO EVERYONE THAT WE WERE MISSING SOMETHING BECAUSE THERE'S A LOT OUT THERE, BUT WE DIDN'T KNOW THAT IT WAS EVEN ORGANIZED IN ANY WAY. SO THE EVALUATIVE CRITERIA WHICH HAS TO BE, I THINK, GOES WITHOUT SAYING, YOU HAVE TO BE ABLE TO EVALUATE WHAT YOU'RE DOING. IT WAS BLATANTLY CLEAR FROM WHAT WAS PRESENTED TO US IN THE FIRST VIEW MEETINGS THAT THERE WAS ALL KINDS OF -- THERE WAS A TREMENDOUS SPECTRUM OF EVALUATION, BUT NOTHING, I WOULD SAY, THAT WE COULD TOGETHER SAY A-HA, THAT'S THE EVALUATION THAT WE WANT TO USE FOR THESE PROGRAMS. I MAY HAVE MISSED SOMETHING, BUT I DON'T THINK THERE WAS ANYTHING THERE. BUT THERE ARE LOTS OF ACTIONABLE ITEMS IN THIS THAT IT REALLY CAN GET THIS THING STARTED, AS OPPOSED TO SOME RECOMMENDATIONS WHERE YOU DON'T KNOW WHERE TO START, THIS ONE IS VERY CLEAR TO ME. >> SO STEVE, I WANT TO ENDORSE WHAT YOU JUST SAID. AND REALLY STEAL A PAGE FROM SOME OF THE CLINICAL RESEARCH I DO LOOKING ON PERFORMANCE IMPROVEMENT AND QUALITY IMPROVEMENT. THE HAWTHORNE EFFECT IS REAL. THE MERE FACT THAT WE HAVE BROUGHT TOGETHER THESE DIFFERENT PROGRAMS INTO AN INVENTORY AND EVERYBODY CAN SEE WHERE WE ARE, THAT'S THE FIRST LEVER OF CHANGE. SO TO MICHAEL'S POINT, PART OF THE AUTHORITY IS GOING TO BE SELF-GENERATED BECAUSE THOSE PROGRAMS ALREADY RECOGNIZE THAT WE ARE AT LEAST IN A DELIBERATIVE PROCESS DISCUSSING THE MERIT -- THE SUCCESS, THE FUTURE VALUE OF THESE PROGRAMS, SO I WOULD ANTICIPATE THAT THE CHANGE MODEL IS ALREADY HAPPENING JUST BY VIRTUE OF SEEING THE DATA THAT WE'VE BROUGHT FORWARD, SO THE PROCESS IIS BEGINNING. >> CLYDE, KATHY HUDSON HERE. THANK YOU FOR A CLEAR PRESENTATION ON THE REPORT. I WAS PARTICULARLY STRUCK AS WAS MIKE WITH THE ISSUE OF EVALUATION, AND IT'S NOT LIMITED TO K-12 BUT ALSO IN COLLEGE ACTIVITIES AS WELL, AND AS YOU KNOW WITH NORMAN AND BILL, THAT THERE IS A STRONG ELEMENT OF BUILDING IN UP FRONT WHAT YOU'RE GOING TO TRY TO ACCOMPLISH AND THEN MEASURING IT VERY CAREFULLY. I'M JUST WONDERING IF YOU IN YOUR WORKING GROUP HAD DISCUSSIONS ABOUT EXACTLY -- THE EVALUATION PIPELINE OR TIMELINE LOOKS TO BE VERY, VERY LONG HERE HERE. ARE THERE SURROGATE MEASURES OR OUTCOME MEASURES THAT YOU CAN THINK OF? BECAUSE OTHERWISE WE WOULDN'T KNOW WHETHER OR NOT WHAT WE'RE DOING IS WORKING FOR MANY YEARS TO COME. SO THAT'S QUESTION ONE. QUESTION TWO IS, IN THE INVENTORY THAT YOU DID OF THESE PROGRAMS, WAS THERE A THOUGHT THAT MANY IS BAD OR MANY IS A SIGN OF LETTING A MILLION FLOWERS BLOOM? YOU MAY KNOW THERE HAS BEEN SOME EFFORT TO AGGREGATE AND CONSOLIDATE STEM EDUCATION PR ACROSS GOVERNMENT AND SOME NOTION THAT THESE TIMES OF PROGRAMS DON'T LIVE BY TOPICS THAT ACTUALLY BY FUNCTION AND SHOULD BE CARRIED OUT BY OTHER FUNCTIONS AND NOT BY NIH? >> TWO VERY GOOD QUESTIONS, KATHY, THANK YOU. GOOD TO SEE YOU. NOON THE COMPUTER SCREEN TODAY. HOPE YOUR WELL. FIRST IS THE TIMELINE FOR EVALUATION. IT'S IMPORTANT TO REFLECT BACK ON THE TESTIMONY THAT WE SAW. PART OF THE TESTIMONY IDENTIFIED THE EARLY AND SIGNIFICANT ATTRITION THAT HAPPENS PARTICULARLY WITH THE UNDERREPRESENTED MINORIS FROM THE POINT OF ENTRY INTO COLLEGES AND UNIVERSITIES TO POINT OF DECLARING A MAJOR TO GRADUATION. THAT'S A ONE TO FOUR-YEAR CYCLE. SO YOU CAN PRETTY QUICKLY DERNL IF SOMEONE THAT WAS IN YOUR SUMMER STEM ENHANCEMENT PROGRAM IS NOW A PERSON WHO IS GOING FORWARD AND DOING MEANINGFUL WORK. I THINK STANFORD EXPERIENCE IS EXEMPLARY HERE BECAUSE IT TRULY IS A SUMMER PROGRAM FOR WHICH THEY NOW HAVE LONGITUDINAL DATA. NOT ONLY WERE THESE CHILDREN SUCCESSFULLY ENTERING MAJOR ACADEMIC INSTITUTIONS, WITH BUT THEY WERE MATRICULATING SUCCESSFULLY AND THEN ENGAGING IN CAREERS IN BIOMEDCAL SCIENCE. SO PART OF THIS TIMELINE IS RELATIVELY SHORT, I WOULD SAY ONE TO THREE YEARS IF IF YOU'RE TALKING ABOUT A SUMMER OR A SERIES OF SUMMER PROGRAMS AT THE HIGH SCHOOL LEVEL. THAT'S VERY DIFFERENT IF WE'RE TALKING ABOUT EARLY CHILDHOOD EDUCATION OR IF WE'RE TALKING ABOUT THE ULTIMATE END GAME HERE, WHICH IS A DEFINED CAREER IN BIOMEDICAL SCIENCES, SOMETHING AS SPECIFIC AS OBTAINING A GRANT SUPPORT, WE KNOW THAT DOESN'T HAPPEN UNTIL PLE ARE IN THEIR LATE 30s, ET CETERA. BUT THERE'S ALSO SOMETHING INTERESTING THAT CAME OUT, KNOWLEDGE THAT MANY OF US ALREADY HAVE. FOR MANY OF THE CHILDREN THAT WE WERE ADDRESS, THEIR TRAJECTORY IS PRETTY MUCH SET BY THE TIME THEY'RE IN MIDDLE SCHOOL. SO THE IDEA OF DOING SOMETHING EARLY ON, THE CHANGES THAT FOCUS THEIR INTERESTS IN SCIENCE AND GETS THEM CONNECTED SO THAT THEIR TEST EVALUATIONS, THEIR PERFORMANCE MEASUREMENTS IN MIDDLE SCHOOL OR AT LEAST IN KEEPING WITH WHAT WOULD BE A SUCCESSFUL COLLEGE ENTRANCE EXAM TO BE FOLLOWED BY SUCCESSFUL ENTRANCE TO SCHOOL, THAT'S ALSO POSSIBLE. THE OTHER THING I'LL TELL YOU ABOUT THIS, KATHY, IS THAT WHEN WE DID BRING IN THOSE PERSONS THAT ARE INVOLVED IN EVALUATING THE EFFECTIVENESS OF EDUCATIONAL PROGRAMS, I FRANKLY LEFT THE ROOM DISAPPOINTED. BECAUSE I WAS STRUCK AT HOW, AGAIN, SUPERFICIAL THE CURRENT EVALUATION PROCESS IS. IT WAS NOT NEARLY AS ROBUST AS I WOULD HAVE LIKED, AND I FOUND ONE OF THE EVALUATIVE CRITERIA TO ACTUALLY BE UNWORKABLE BECAUSE IT ESSENTIALLY SAID SO WE DISCOVERED THAT CHILDREN THAT COME FROM DISADVANTAGED ENVIRONMENTS DON'T DO WELL. WELL, THE ENTIRE POINT OF THIS IS TO UNDERSTAND WHY IS THAT AND WHAT CAN WE DO DIFFERENTLY, AND ARE WE TESTING THE RIGHT THING WHEN WE'RE LOOKING AT THOSE CHILDREN. NOW LET ME TRANSITION TO THE SECOND QUESTION, BECAUSE IT IS VERY IMPORTANT THAT WE DISCUSS THIS. WE ARE NOT SUGGESTING THAT WE KNOW THE NUMBER OF PROGRAMS THAT THE NATIONAL INSTITUTES OF HEALTH SHOULD SUPPORT. WE EMBRACE THE NOTION THAT EVERY INSTITUTE RESPONDED WITH A STEM INITIATIVE. THAT TELLS US THAT SOMEWHERE EMBEDDED IN THE MINDSET OF THE NIH, THERE IS ALREADY ESTABLISHED A IMPORTANT SYSTEM OF EDUCATION. IT COULD BE THAT WE NEED MORE PROGRAMS, IT COULD BE THAT WE NEED FEWER PROGRAMS, BUT WHAT'S REALLY IMPORTANT IS WE NEED TO KNOW ARE THE PROGRAMS WE'RE ALREADY SUPPORTING WORKING. UNTIL WE HAVE THE EVALUATION A SUCCESS, WE CAN NEITHER UNDERSTAND THE NUMBER OF PROGRAMS, NOR CAN WE UNDERSTAND THE SCOPE OR THE RANGE OR THE TARGETS OF THOSE PROGRAMS SO WE REALLY ARE STARTING AT GROUND ZERO IN THIS EVALUATIVE PROCESS AND I WOULD NOT WANT THIS REPORT TO GIVEN THE SHORT SH RIFF AND WANT SOMEONE TO THINK THAT WETIOUS TRUNCATE WHAT WE HAVE. WE SPECIFICALLY LEFT ECONOMIC METRICS OUT OF THE REPORT BECAUSE WE DIDN'T WANT THAT TO BE A TARGET FOR WHAT SHOULD HAPPEN NEXT. WHAT SHOULD HAPPEN NEXT IS A STRICT EVALUATION PROCESS. >> THANK YOU. >> CLYDE, THANK YOU FOR THE TERRIFIC REPORT. IN MANY, MANY WAYS. ONE QUESTION I HAD IS THAT YOU'VE STRESSED HOW EARLY KIDS GET TURNED OFF BASICALLY OR LOSE, AND YOU TALKED ABOUT TRAINING ELEMENTARY TEACHERS. OR THE NEED FOR THAT AS ONE APPROACH. WHETHER THAT'S AWR ROLE OR NOT, BUT WAS THERE ANY DISCUSSION ABOUT WORKING WITH PARENTS AND COMMUNITIES? BECAUSE ALSO BY WORKING WITH COMMUNITIES, YOU CAN BRING ABOUT GREATER INVOLVEMENT OF KIDS IN WHATEVER IT IS YOU'RE INTERESTED IN. >> SO THAT'S A GOOD STATEMENT AND I APPRECIATE THE COMMENT. IN OUR DISCUSSIONS, I WANTED TO GIVE YOU ONE METRIC THAT I THINK FLOORED ALL OF US. WHEN WE LISTENED TO THE CURRENT LEVEL OF EXPECTATION FOR CONTINUING EDUCATION FOR THOSE THAT ARE ENTRUSTED WITH THE RESPONSIBILITY TO TEACH SCIENCE TO OUR CHILDREN AND OUR SECONDARY KIDS OVER A TWO TO THREE-YEAR PERIOD, IT'S A FIVE HOUR MINIMUM. FIVE HOUR MINIMUM. THAT JUST SEEMS TO BE SO OUT OF SINSYNC TO WHERE WE NEED TO GO, SO THAT BEGINS THE CONVERSATION. NOW WHERE THE CONVERSATION NEEDS TO GO FROM THAT IS THAT SOMEONE WITH AUTHORITY NEEDS TO SAY WE NEED TO SEE THIS DONE DIFFERENTLY AND WHO HAS MORE AUTHORITY THAN PARENTS? SO MANY OF THE PARTIES THAT WE ENTERTAIN BY WAY OF TESTIMONY IN APPENDIX A HAS THE LIST OF THOSE INDIVIDUALS THAT GAVE US TESTIMONY ALL CAME TO THAT CONCLUSION THAT SOMEHOW OR ANOTHER WE NEED TO DO A BETTER JOB OF GETTING INVESTMENT FROM FAMILIES IN STEM EDUCATION. SO WE BELIEVE THIS IS AN IMPORTANT ISSUE, BUT I WILL ALSO GO BACK TO THE POINTS YOU MADE, AND LARRY TABAK WAS ESPECIALLY ARTICULATE ABOUT THE NECESSITY TO KEEP OUR SCOPE WITHIN REASON. SOME OF THIS REALLY IS YOBD THE BEYOND THE PURVIEW OF THE NIH, WE GET THAT, AND THIS IS WHERE LEVERAGING WITH THE EDUCATION DEPARTMENT, THE NATIONAL SCIENCE FOUNDATION, TALKING ABOUT WAYS THAT THE NIH CAN HELP POPULATE THE CURRICULUM, TALKIN WAYS THAT WE CAN PROVIDE OUTREACH ACTIVITIES FOR THE TEACHERS, IS THE ROLE THAT WE CAN PLAY, BUT THE NIH CANNOT OWN THE PREPAREDNESS OF SCIENCE TEACHERS, THAT IS OUTSIDE OF OUR PURVIEW. >> I JUST WANTED TO IN SOME WAYS ECHO WHAT CLYDE HAS SAID SO THOUGHTFULLY AND ARTICULATELY. AND IT'S PARTLY IN RESPONSE TO KATHY'S QUESTION. I THINK WHAT WE RATHER QUICKLY MANAGED TO FOCUS ON ON A WORKING GROUP WAS THIS SUBSET OF QUESTIONS RELATED TO STEM EDUCATION FOR UNDERREPRESENTED MINORITIES. IT IS WITH THAT FOCUS THAT I THINK EVALUATION BECOMES MORE PRACTICAL, THAT IF YOU SAY OKAY, OF ALL THE THINGS OUR EDUCATION PMS ARE GOING TO DO MANY GREAT THINGS, BUT WE IN OUR EVALUATION SHOULD FOCUS ON ARE THEY MAKING SENSE AS STEPS IN THIS PARTICULAR PROBLEM. AND OBVIOUSLY WE ARE THINKING A LOT ABOUT THE DIVERSITY OF OUR WORKFORCE AND THE PROBLEMS WE HAVE IN THIS, SO THIS IS A PROBLEM THAT IT MAKES SENSE FOR US TO OWN. >> CAN I JUST ADD ONE THING TO WHAT JOSIE SAID, AND THAT IS THIS VERY THOUGHTFUL LETTER FROM DR. DUREMER FROM MAHARI MEDICAL COLLEGE, IN WHICH SHE DOES SAY, AND I THINK IT'S AN IMPORTANT POINT WITH REGARD TO EVALUATION, THAT OVERSIMPLIFICATION OR FOCUS ON ONLY ONE END POINT IS A MISTAKE. SO THE CHARGE SHOULDN'T BE AN EVALUATION OF A PROGRAM, BUT EVALUATION OF PROGRAMS THAT WILL NOT NECESSARILY COME TO THE SAME END POINT. >> I WANT TO ENDORSE THAT AS WELL. I THINK IT WAS A VERY WELL WRITTEN LETTER AND IT WOULD SUGGEST THAT THERE WILL NOT BE ONE TEMPLATE IN AND OF ITSELF THAT WILL ANSWER EVERY QUESTION, BUT AGAIN, I THINK THERE IS A FLOOR WE SHOULD HAVE AND THEN A PROCESS TO CAPTURE THE NUANCES OF THESE MANY DIFFERENT PROGRAMS SO THAT DIFFERENT PROGRAMS CAN SPECIFICALLY ARTICULATE WHAT DEFINES THEIR OWN SUCCESS. IT MIGHT BE A VERY HEALTHY EXERCISE TO JUST HAVE THESE PROGRAMS TELL US WHAT DOES SUCCESS MEAN IN TERMS OF THEIR ORIGINAL GOALS AND THE ORGANIZATION OF THE PROGRAM. THAT CAN BE VERY ENLIGHTENING. >> JUST A SPECIFIC QUESTION, YOU MENTIONED HOW WE ARE ALL FLOORED BY THE FIVE-HOUR MINIMUM OF CONTINUING EDUCATION. I DON'T RECALL WHETHER THAT WAS A NATIONAL AMPLE O AVERAGE OR SOME PARTICULAR STATE OR WHAT. CAN YOU REFRESH ME ON THAT? >> THAT WAS A STATEMENT THAT CAME FROM THE GROUP OF TEACHERS THAT VISITED WITH US, AND MY UNDERSTANDING, I DON'T WANT TO BE OVERLY SPECIFIC HERE BECAUSE I KNOW THAT THERE IS A PUBLIC RECORD BEING KEPT AND I'D LIKE FOR THIS TO BE PRECISE. I'M GOING ON RECALL, BUT MY UNDERSTANDING IS THAT LARGE MEASURE CAN DID NOT REFLECT JUST ONE JURISDICTION, ONE COMMUNITY OR ONE STATE, BUT RATHER COLLECT -- REFLECT THAT THE EXPECTATION FOR CONTINUING EDUCATION FOR THE BODY OF SCIENCE TEACHERS, BUT WE CAN CERTAINLY GO BACK AND BEFORE THE REPORT IS FINALIZED, GET THE RIGHT ATTRIBUTION FOR THAT METRIC. >> CLYDE, THANK YOU. MAYBE I'LL ASK A FEW OF YOUR FOLKS TO DO THAT. THAT'S A VERY IMPORTANT QUOTABLE FIGURE THAT I'D LIKE TO BE ABLE TO USE, BE GOOD TO HAVE IT RIGHT. CLYDE, I THINK WE'VE COVERED QUESTIONS HERE. DO YOU HAVE ANYTHING ELSE YOU WOULD LIKE TO SAY? >> NO, AGAIN, I JUST WANT TO THANK ENTEROVIRUS ONE WHO HAS BEEN BENEFICIAL. I KNOW THAT NANCY ANDREWS IS IN THE ROOM, I JOSEPHINE IS IN THE ROOM, STEVE KATZ AND I COMAINGED EXAINGED EMAILS. I THINK GILL IS ON THE PHONE, THIS REPORT WOULD NOT HAVE BEEN WHAT IT IS WITHOUT HIS STEADFAST ATTENTION TO THE DETAILS AND I CAN'T THANK HIM ENOUGH FOR THAT. AND THEN EVERYBODY ELSE IN THE REPORT, JUST TERRIFIC WORK. NORM, YOU'RE NUDGING YOUR SUPPORT, JUST YOUR PRESENCE REALLY GAVE US THE OPPORTUNITY TO DO THIS AND DO IT AS WELL AS WE COULD, SO I'M VERY GRATEFUL TO SO MANY FOR WHAT WE'VE BEEN ABLE IT TO DO, AND I HOPE THIS IS JUST THE FIRST STEP. THIS WON'T MAKE A DIFFERENCE IF WE DON'T ADDRESS THE PROBLEM OF STEM EDUCATION, SO I'M HOPING THIS IS THE NEXT STEP IN THE RIGHT DIRECTION. >> CLYDE, THANK YOU SO MUCH FOR ALL YOUR GOOD WORK ON THIS, AND I USED TO WORK WITH A GENTLEMEN SOME YEARS AGO AT THE DEFENSE DEPARTMENT THAT ALWAYS SAID WHEN YOU TURN IN YOUR REPORT, YOUR WORK HAS BEGUN. SO THIS SOMEONE OF THOSE AREAS, I THINK, THAT THAT'S TRUE. >> MAY I MAKE A BRIEF COMMENT? >> YES, PLEA, BY ALL MEANS. >> I JUST WANT TO PICK UP ON THE COMMENTARY THAT SOMEONE JUST REFERRED TO IN THE LETTER FROM VANDERBILT ABOUT SCIENCE AND MATH. WE'VE WORKED VERY HARD AND WITH REMARKABLE LEADERIP FROM CLYDE TO FOCUS ON THIS REPORT WHAT WE THOUGHT WAS MOST IMPORTANT. THERE ARE SOME OTHER DETAILS IN THE REPORT, LIKE THAT FIGURE TWO ABOUT THE VARIOUS CAREER PATHS UNDER BIOMEDICAL WORKFORCE, ONE OF WHICH IS COMPUTATIONAL BIOLOGIST, AND IN SEVERAL PLACES PLACES, INCLUDING PAGE 11, THERE'S A COMMENT ABOUT THE NEED FOR BRINGING MATHEMATICAL SKILLS TO MODERN BIOLOGY, SO THERE IS EMBEDDED IN THIS REPORT SOME RECOGNITION OF THE SPECIAL DEVELOPMENTS THAT NEED TO BE ATTENDED TO UNDER THIS IT PREPARATION FOR MINORITIES AND NON-MINORITIES FOR CAREERS IN BIOMEDICAL WORKFORCE. BUT WE ALL AGREE THAT WE OUGHT TO PUT THE EMPHASIS WHERE WE THOUGHT THE NEED WAS GREATEST AND EFFICIENCY WAS THE GREATEST AND I THINK WE HAVE DONE AN INCREDIBLE JOB ON THAT. >> GILL, THANK YOU. IS THERE ANYONE ELSE ON THE LINE WHO WOULD LIKE TO MAKE A COMMENT? >> HANNAH VALANTINE HERE. I WANT TO THANK THE COMMITTEE AND CLYDE FOR THIS FANTASTIC REPORT. AS I LISTENED TO THE PRESENTATION, IT SO CLEARLY RESONATES WITH THE CHARGE OF MY OFFICE IN GOING FORWARD AND EVEN LOOKING BACK AT WHAT PROGRAMS THERE ARE IN DIVERSITY, THERE MUST BE FULL ATTENTION TO COORDINATION, EVALUATION AND ULTIMATELY ACCOUNTABILITY FOR THE PROGRAM. SO I THINK PUTTING THAT INTO THE CONTEXT OF ALL OF THE NEW DIRECTIONS OF THE NIH, IT'S ABSOLUTELY IN IT. NOW WHAT THE NEXT STEPS WILL BE, YOU CLEARLY ARTICULATED WILL BE UP TO THE NIH DIRECTOR, BUT I DO BELIEVE THAT AS SOMEBODY MENTIONED, THERE'S LOTS OF ACTIONABLE ITEMS THERE, AND YET THOSE ITEMS ARE NOT IN ISOLATION. THEY'RE VERY MUCH PART AND PARCEL OF WHAT WE'RE DOING FOR THE ENTIRE BIOMEDICAL RESEARCH WORKFORCE AND THE CAREER PATH. SO I JUST WANTED TO THANK EVERYBODY, AND IT'S GIVEN ME A LOT OF GOOD THINGS TO THINK ABOUT. >> THANK YOU FOR THOSE WORDS. IS ANYBODY ELSE ON THE LINE THAT WOULD LIKE TO COMMENT? HEARING NONE, CLYDE, WOULD YOU LIKE TO CALL FOR THE VOTE? >> I WILL DEFER TO YOU, NORP. THANK YOU. >> OKAY. YOU'VE HEARD THE DISCUSSION. THE QUESTION IS WHETHER WE SHOULD APPROVE THE PANEL REPORT. AND I WOULD WELCOME A MOTION. >> SO MOVED. >> THANK YOU. IS THERE A SECOND? >> SECOND. >> SECONDS HERE BY THE DOZEN. IS THERE FURTHER DISCUSSION? W ALL THOSE IN FAVOR OF APPROVING THIS REPORT PLEASE SAY AYE? OPPOSED? ALL RIGHT, THAT'S UNANIMOUS. WE'LL RECORD IT THAT WAY IN THE MINUTES, PLEASE. ONCE AGAIN, CLYDE, THANKS TO YOU, TO YOUR GROUP AND THE STAFF THAT SUPPORTED YOU. >> THANK YOU INVEST. >> AT THIS POINT, I THINK WE'RE PRETTY CLOSE TO ON SCHEDULE. MARINA, I'M SUPPOSED TO TURN THE CHAIR OVER TO YOU FOR A MOMENT. >> IT IS WITH GREAT REGRET THAT I HAVE TO TELL YOU THAT AMY PATTERSON WANTED VERY MUCH TO BE HERE TODAY BUT SHE HAS A PERSONAL FAMILY ISSUE TO DEAL WITH. BUT SHE WOULD HAVE -- SHE WANTED TO COME, GIVEN YOUR LONG WORKING RELATIONSHIP, NORM, SHE WAS GOING TO COME AND THANK YOU AGAIN. I THINK FRANCIS SAID IT ALL VERY ELOQUENTLY EARLIER, BUT WE ARE ALL VERY INDEBTED TO YOU AND YOUR WONDERFUL LEADERSHIP OF THIS GROUP. I THOUGHT -- YOU KNOW, I KNOW THAT YOUR WISDOM HAS GIVEN US SO MUCH AS WE CONTINUE THESE DELIBERATIONS, SO WE THOUGHT WE WOULD JUST GIVE SOME GOOD EXAMPLES OF YOUR WISDOM, JUST LITTLE PERFECTLIES. I DONE KNOW IF YOU ALL KNOW, THERE IS A WEBSITE AVAILABLE OF NORM AUGUSTINE QUOTES, AND I HIGHLY RECOMMEND IT. IT'S ONE OF MY FAVORITES. IT'S ONE OF MY FAVORITE WEBSITES. I TELL YOU, THE SMRB STAFF, WE SPEND A LOT OF TIME ON IT. BUT JUST TO GIVE YOU -- I'LL GIVE YOU KATHY'S FAVORITE FROM THE QUOTES THAT WE PULLED, "IF A SUFFICIENT NUMBER OF MANAGEMENT LAYERS ARE SUPERIMPOSED ON TOP OF EACH OTHER, IT CAN BE ASSURED DISASTER IS NOT LEFT A CHANCE. THIS IS INDICATIVE OF YOUR WONDERFUL LEADERSHIP, AND I HAVE TO ADMIT MY FAVORITE, WHICH I THINK IS JUST INCREDIBLY WISE, IS "THE EARLY BIRD GETS THE WORM. THE EARLY WORM GETS EATEN." WITH THAT, NORM, I'M GOING TO GIVE YOU WHAT YOU'VE BEEN WAITING FOR. IT'S YOUR CERTIFICATE. >> THANK YOU. >> AND JUST NIH'S ETERNAL GRATITUDE. AS I SAID, I THINK DR. COLLINS SAID IT ALL, BUT NORM, THANK YOU AGAIN FOR YOUR MANY YEARS -- [APPLAUSE] >> WELL THANK YOU ALL VERY MUCH. AND IT'S BEEN NOT ONLY AN HONOR BUT A PRIVILEGE TO FILL THIS CHAIR FOR 24 MEETINGS. AND TO ME, NIH IS A NATIONAL ASSET. IT'S A GLOBAL ASSET ACTUALLY. I VIEW THE RESPONSIBILITY THAT WE AROUND THIS TABLE HAD IS JUST HAD A SERIOUS RESPONSIBILITY, AND AS I USUALLY SAY TO EACH NEW GROUP WE SET UP, THAT THAT PUTS ON A LOT OF PRESSURE ON YOU, BECAUSE THERE'S A DANGER THAT SOMEBODY MIGHT ACTUALLY GO DO WHAT YOU SUGGEST. SO FAR I THINK THE GROUPS HAVE DONE VERY WELL, AND MY ADMIRATION FOR THE PEOPLE OF NIH INCREASES WITH EACH MEETING. THIS IS MY THIRD MAJOR PROJECT THAT I'VE WORKED ON WITH NIH, AND I THINK BACK WHEN I FIRST BECAME A PUBLIC SERVANT, I VIEWED THAT AS A MATTER OF GREAT PRIDE. I COULDN'T THINK OF ANYTHING HARDLY NOR SIGNIFICANT THAN TO BE A SERVANT OF THE PUBLIC. UNFORTUNATELY THAT'S TAKEN ON A NEW MEANINGS, BUT TO ME, THE PEOPLE AT THE NIH ARE THE FINEST OF PUBLIC SERVANTS, AND WHEN YOU THINK WHAT YOU DO FOR THE NATION, SO THANK ALL OF YOU AROUND THE TABLE FOR THE PRIVILEGE OF BEING PART OF THIS. YOU'VE PERMITTED AN EDUCATOR TO SIT AT YOUR TABLE, WHICH WAS NICE OF YOU. I HAPPEN TO BELIEVE THAT IT WILL BE A COMPLI NATIO COMBINATION OF ENGINEERI NG AND BAY OWE MEDICINE THAT'S GOING TO CHANGE THE WORLD IN THE YEARS AHEAD, SO WE'LL WAIT AND SEE. SPECIAL THANKS TO THE STAFF, TO AMY, TO MARINA, I WON'T START DOWN THE LIST, THAT WOULDN'T BE A GOOD IDEA, BUT TALK ABOUT A CAN-DO STAFF. THEY'VE BEEN TERRIFIC. AND ALSO APPRECIATE THE KIND WORDS OF MARINA AND THE WORDS THAT FRANCIS MENTIONED THIS MORNING, AND I THINK I MAY HAVE TOLD THIS STORY BEFORE BUT IT'S A GOOD STORY SO I'LL RISK IT AGAIN. WHEN I HEAR ALL THOSE KIND WORD. I HAVE A FRIEND DAVID ROCK RICK WHO USED TO BE C OA. OF U.S. STEEL. THE PERSON WHO INTRODUCED HIM SAID DAVID WAS ONE OF AMERICA'S MOVE GIFTED BUSINESS PERSONS. HE SAID DAVID PAID $10 MILLION IN CALIFORNIA OIL. WHEN DAVID GOT TO THE PODIUM, YOU COULD SEE HE WAS SOMEWHAT EMBARRASSED HE SAID THE INTRODUCTION WAS FAIRLY ACCURATE BUT IT WASN'T CALIFORNIA, IT WAS PENNSYLVANIA, IT HADN'T BEEN OIL THAT WAS COLD. AND IT WASN'T 10 MILLION, IT WAS 10,000. AND IT WASN'T HE, IT WAS HIS BROTHER. AND HE DIDN'T MAKE IT, HE LOST IT. [LAUGHTER] >> SO WITH THAT, THANK YOU ALL VERY MUCH. BEFORE WE -- BEFORE WE WRAP UP, I DON'T WANT TO DEPART FROM MY PRACTICE AT THIS LAST MEETING. I ALWAYS LIKE TO GO AROUND THE TABLE, GIVE EVERYBODY A CHANCE TO SAY IS THERE SOMETHING YOU WISH YOU HAD THE CHANCE TO SAY THAT YOU DIDN'T SAY OR SOMETHING THAT YOU'RE CONCERNED ABOUT OR ANYTHING ON YOUR MIND. YOU DON'T HAVE TO SAY ANYTHING BUT IF THERE IS SOMETHING THAT ANYBODY WOULD LIKE TO RAISE, WANT TO GIVE YOU THE CHANCE. MICHAEL? >> DO WE GET A CHANCE TO TAKE THINGS BACK THAT WE MAY HAVE SAID? NO, I'M SET. >> OKAY. JOSIE? >> I'M SET TOO, BUT NORM, YOU WILL BE VERY MUCH MISSED. IT'S BEEN TERRIFIC. >> THANK YOU. >> HAVE BEEN WITH YOU SINCE THE BEGIN, I CAN TELL YOU I'VE LEARNED A LOT OF THINGS FROM YOU. A LOT OF QUOTES. >> WE'RE THE VETERANS. MARTHA? >> SAME THING. THANK YOU SO MUCH FOR ALL YOU'VE DONE FOR US. >> SCOTT. >> MY TENURE ON THIS COMMITTEE HAS BEEN SHORT BUT IT'S BEEN A REAL HONOR AND PRIVILEGE TO BE HERE DURING YOUR TENURE. I'VE REALLY ENJOYED THE CHANCE TO GET IT TO KNOW YOU EVEN IN THIS SHORT PERIOD OF TIME. THANK YOU FOR THAT. I ALSO COMMENT, I REALLY THANK COMMITTEE TODAY IN GRAPPLING THESE ISSUES, BUT I THINK IT WAS A VERY EXCELLENT DISCUSSION AND ENGAGEMENT AND REALLY THOUGHTFUL PROCESS AND HOPEFULLY THAT WILL MOVE FORWARD. >> FOR SURE. GRIFF? >> I ALSO WANT TO THANK YOU ALSO, INAUGURAL MEMBER OF THE SMRB, AND YOUR WISDOM AND LEADERSHIP HAS COME ACROSS. I HAD THE PRIVILGE OF ACTUALLY -- LAST YEAR AT THE LEADERSHIP DEVELOPMENT CLASS WITH NORM, AND AT THAT MEETING, THERE WERE A NUMBER OF THESE NORMISMS THAT WERE CITED, AND I CAN TELL YOU, UNFORTUNATELY YOU HAD HAD ANOTHER MEETING TO ATTEND AFTERWARD, BUT TO A PERSON, THEY ALL COMMENTED UPON HOW INSPIRATIONAL YOUR WORDS WERE, AND CERTAINLY BEEN TO THIS COMMITTEE, SO THANKS AGAIN. >> I HAD A GOOD TIME. >> AND I'M SURE THAT AS FRANCIS SAYS, OUR CONNECTIONS REALLY WON'T BE SEVERED, WE WILL FIND SOME OTHER MECHANISM TO BRING YOU BACK. >> THANKS, GRIFF. > AND I JUST WANT TO ADD TO THE COMMENTS ABOUT YOU, NORM, GRIFF USED THE WORD WISDOM AND IT IS YOUR WISDOM ABOUT PEOPLE, ABOUT SCIENCE, TECHNOY, ABOUT INSTITUTIONS, IT'S BEEN SO HELPFUL TO US. I THINK WE ALL HAVE LEARNED A LOT FROM YOU. I THINK WE ALSO THANK YOU, OF COURSE, FOR YOUR SAYING SOMETHING ABOUT THE PUBLIC SERVICE PART OF THIS. BUT YOU ARE THE ROLE MODEL FOR THAT. WE AT LEAST GET PAID FOR ALL THE TIME THAT WE GIVE TO THE NIH. AND THE FACT THAT YOU HAVE GIVEN THIS INCREDIBLE LEADERSHIP AND WISDOM AT THE -- WITH ALL THE THE FREE COFFEE THAT WE DON'T GIVE YOU THROWN IN, IS REALLY REMARKABLE. AND -- WE'LL SEND YOU BANANAS. RIGHT. [INAUDIBLE]