>> GOOD MORNING, EVERYONE. PLEASE GET READY FOR A FUN DAY I WANT TO WELCOME YOU TO THE 43RD NIH ADVISORY COMMITTEE ON RESEARCH ON WOMEN'S HEALTH MEETING. REMIND YOU THIS MEETING IS OPEN TO PUBLIC AND BROADCAST ON NIH VIDEOCAST NETWORK. AS A REMINDER ALL COUNCIL MEMBERS HAVE THE OPTION OF PARTICIPATING REMOTELY IN ONE MEETING PER YEAR PROVIDED WE HAVE ADVANCE NOTICE. I WANT TO KNOW IF WE HAVE ANYONE ON THE PHONE. IS THERE ANYONE ON THE PHONE? >> YES. >> GOOD MORNING. DR. GEERT DEVRIES IS JOINING US REMOTELY. WE MAY HAVE ANOTHER SPECIAL COMMITTEE GUEST ON THE PHONE, IS THERE MARSHA STEFANICK THERE? NOT THERE YET. THANK YOU, GEERT. WHAT WE'LL DO NOW IS DO INTRODUCTIONS AROUND THE TABLE WE HAVE DIFFERENT ADVISE RAISE COMMITTEE MEMBERS. I'M JANINE CLAYTON, DIRECTOR OFFICE OF RESEARCH ON WOMEN'S HEALTH AND NIH ASSOCIATE DIRECTOR FOR RESEARCH WOMEN'S HEALTH. >> I'M LIZ SPENCER DEPUTY DIRECTOR (INAUDIBLE). >> I'M ANGELA -- PROFESSOR CHAIR UNC CHAPEL HILL. ANGELA KASHUBA. GO HEELS. [APPLAUSE] >> SCHOOL OF PHARMACY AND MEDICINE ON THE CLINICAL PHARMACOLOGIST AND DO HIV RESEARCH AND ALSO PART OF BUNCH. >> I'M JUDY REGENSTEINER, PROFESSOR OF MEDICINE DENVER SCHOOL OF MEDICINE, BIRCH PI AND DIRECTOR OF WOMEN AND SCIENCE GROUP FOR DEAN. I ONLY A BIG FAB OF THE ORWH, MY LAST MEETING AFTER FIVE YEARS. I WILL MISS IT A LOT. >> GOOD MORNING. I'M KIMBERLY GREGORY, VICE CHAIR OBGYN CEDARS SINAI MEDICAL CENTER. I'M PROFESSOR THERE AT CEDARS AND UCLA SCHOOL OF MEDICINE AND SCHOOL OF PUBLIC HEALTH AND HEALTH SERVICE RESEARCHER WITH QUALITY OF CARE AND PATIENT REPORTED OUTCOMES FOR CHILDBIRTH. >> EMERAN MAYER, CERTAINTY FOR NEUROBIOLOGY OF STRESS. >> I'M RACHEL JOHNS, ASSOCIATE PROFESSOR SCHOOL OF NURSING IN NORTH EASTERN UNIVERSITY. >> I'M KNEEL -- UNIVERSITY OF PENNSYLVANIA WHERE I'M ALSO DIRECTOR OF PROMOTE RESEARCHER SEX GENDER AND HEALTH AND BIRCH. >> (INAUDIBLE) DEPARTMENT OF OBSTETRICS AND GYNECOLOGY AND EPIDEMIOLOGY, I DIRECT CENTER FOR WOMEN'S HEALTH RESEARCH AT UNC. >> I'M CAROLYN AT THE YALE SCHOOL OF MEN SIN, PROFESSOR PSYCHOLOGY AND SIGH ALCOHOL AND I DIRECT THE PROGRAM THAT AT YALE AND SEX AND GENDER RESEARCH. INTERDISCIPLINARY CENTER. I'M A SCIENTIFIC DIRECTOR FOR THE L SCORE. CAROLYN MAZURE. >> I'M MARY PALMER FROM THE UNIVERSITY OF NORTH CAROLINA CHAPEL HILL. I AM THE DISTINGUISHED PROFESSOR AGING AND SCHOOL OF NURSING. >> I'M THERESA WOODRUFF, VICE CHAIR VERGE OBGNY NORTHWESTERN UNIVERSITY AND DIRECTOR OF WOMEN'S HEALTH RESEARCH INSTITUTE. >> GOOD MORNING. I THINK THERE'S A LITTLE DISPROPORTIONATE TAR HEEL ACTION GOING ON HERE: JANINE, I HOPE YOU WILL TAKE CARE OF THIS. IF NOT, LIZ. I'M CARMEN GREEN, UNIVERSITY OF MICHIGAN AND WHERE I'M PROFESSOR OF ANESTHESIOLOGY OBSTETRICS AND GYNECOLOGY AND HEALTH MANAGEMENT AND POLICY. I -- RESEARCH IS ON PAIN AND PAIN CARE DISPARITIES AACROSS THE LIFE SPAN, SOCIAL DETERMINANTS OF HEALTH. GOOD TO SEE YOU. >> GOOD MORNING, MY NAME IS WEN CHEN, PROFESSOR NEUROSCIENCE TEXAS A AND M COLLEGE OF MEDICINE. >> MY NAME IS ANA MARIA LOPEZ. PROFESSOR OF MEDICINE UNIVERSITY OF UTAH WHERE I'M ASSOCIATE VICE PRESIDENT FOR HEALTH EQUITY AND DO RESEARCH LOOKING AT ACCESS TO CARE, PRIMARILY USING TELEMEDICINE. >> HELLO, I'M CONNIE WEAVER, NUTRITION SCIENCE AT PURDUE UNIVERSITY WHERE I'M ALSO DIRECTOR OF THE WOMEN'S GLOBAL HEALTH INSTITUTE. >> I'M JILL BECKER, I'M PROFESSOR OF PSYCHOLOGY AND PSYCHIATRY AND MEMBER OF THE MOLECULAR AND BEHAVIORAL NEUROSCIENCE INSTITUTE. I DO BASIC RESEARCH ON SEX DIFFERENCES, AND ADDICTION. >> I'M LOUISE MCCULLOUGH, I'M A GUEST, I AM THE CHAIR OF NEUROLOGY AT THE UNIVERSITY OF TEXAS AND ALSO A NEUROSCIENTIST THAT STUDIES BASIC AND TRANSLATIONAL STROKE AND VASCULAR BIOLOGY, BEEN INVOLVED IN WOMEN'S HEALTH AS PRIOR PRESIDENT OF THE OSSD AND HAVE DONE A LOT WITH BASIC CELL DEATH MECHANISMS AND SEX DIFFERENCES. THANK YOU. >> THANK YOU, EVERYONE. ANYBODY ELSE JOIN ON THE PHONE? GEERT PLEASE SURE TO SPEAK UP IF YOU HAVE A QUESTION OR COMMENT TO MAKE. WE WANT YOU TO BE ABLE TO PARTICIPATE FULLY, OKAY? >> I WILL DO. >> GREAT. AT THIS TIME IT'S MY DUTY TO REMIND YOU AS ADVISORY COMMITTEE MEMBERS YOU ARE SPECIAL GOVERNMENT EMPLOYEES AND THAT MEANS YOU'RE SUBJECT TO ETHICS RULES THAT APPLY TO GOVERNMENT EMPLOYEES. THESE RULES WERE DESCRIBED IN THE PAMPHLET YOU RECEIVED AT ORIENTATION AND ENTITLED STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE EXECUTIVE BRANCH. AT EVERY MEETING WE LIKE TO REVIEW THE STEPS WE TAKE AND THE PROCESS WE FOLLOW SO THAT ANY CONFLICTS BETWEEN YOUR PUBLIC RESPONSIBILITIES AND YOUR PRIVATE INTERESTS IN ACTIVITIES ARE BOTH IDENTIFIED AND ADDRESSED. AS YOU KNOW BEFORE EVERY MEETING YOU PROVIDE US WITH A GREAT DEAL OF INFORMATION AND FINANCIAL BACK GROUND AS FOUNDATION FOR ASSESSING WHETHER OR NOT YOU HAVE ANY REAL POTENTIAL OR APPARENT CONFLICTS OF INTEREST THAT COULD COMPROMISE YOUR ABILITY TO BE OBJECTIVE IN GIVING ADVICE DURING COMMITTEE MEETINGS. I WOULD LIKE TO REMIND YOU TO LET ME KNOW IF AN ISSUE COMES UP THAT WE MAY NOT HAVE ANTICIPATED AND THERE PEERS OR COULD BE POTENTIAL FOR CONFLICT, PLEASE RECUSE YOURSELF AND LET ME KNOW. BEFORE WE MOVE TO OUR FIRST AGENDA ITEM I WANT TO LET YOU KNOW THE MINUTES FROM THE SEPTEMBER 27th MEETING WERE DISTRIBUTED AND POSTED AND I WOULD LIKE TO HAVE A MOTION TO APPROVE THE MINUTES OR ANY COMMENTS THAT NEED TO BE MADE FOR THE MINUTES SHOULD BE MADE AT THIS TIME. DO I HAVE A MOTION TO APPROVE MINUTES AS PREPARED IN >> SO MOVED. >> IS THERE A SECOND? SECOND FROM DR. PALMER, MOTION FROM DR. MAZURE. ALL THOSE IN FAVOR OF ACCEPTING THE MINUTES AS PREPARED, PLEASE SIGNIFY BY SAYING AYE. >> AYE. >> ANY OPPOSED? ANY ABSTENTIONS? >> ALL RIGHT. MINUTES ARE APPROVED AS READ. THANK YOU, VERY MUCH. SO THIS IS ONE OF MY FAVORITE PARTS OF THE MEETING AND THAT IS GETTING TO SHARE WITH YOU ALL OF THE FUN THINGS WE HAVE DONE OVER THE PAST YEAR. SO I'M GOING TO COME OVER TO THE PODIUM TO DO THAT AND I'M LOOKING FORWARD TO YOUR COMMENTS AND QUESTIONS AND LIVELY DISCUSSION. SO I'M GOING TO SCOOT OVER THERE. WHILE YOU'RE DOING THAT, JANINE HAS JUST BEEN RECEIVING A LOT OF AWARDS THIS YEAR WHICH ENHANCE IT IS STATUS OF THE ORGANIZATION. I SAW SHE RECEIVED ONE FROM AMERICAN MEDICAL ASSOCIATION AND, VERY IMPRESSIVE FORMALLY COMMEND HER ON THAT PARTICULAR WORK UNLESS SHE WAS GOING TO SPEAK ABOUT THAT. [APPLAUSE] >> THANK YOU, DR. GREEN. WE WILL TALK ABOUT THAT AND I WILL TELL YOU I BELIEVE POLICY RESONATES WITH SO MANY PEOPLE IN TERMS OF WHAT WE NEED BUT THAT IS WHAT'S DRIVING RECOGNITION. I'M EXCITED TO BE ABLE TO GIVE YOU MY DIRECTOR'S REPORT HERE AT THIS 43RD MEETING. I BEGIN VIRTUALLY EVERYONE OF MY PRESENTATIONS WITH THIS SLIDE. BECAUSE WE HAVE TO START WITH THE BEGINNING OF THIS OFFICE. THIS OFFICE IS DIFFERENT. BEFORE I GO FURTHER I DO WANT TO RECOGNIZE IN THE AUDIENCE DIRECTOR OF NATIONAL INSTITTE FOR MENTAL HEALTH DR. JOSH GORDON. AND DR. RICHARD NAKAMURA, WAS SITTING NEXT TO HIM A WHILE AGO AND WILL BE BACK SPEAKING TO US LATER TODAY. THANK YOU SO MUCH FOR BEING HERE, JOSH. BUT THE MISSION OF THIS OFFICE AS YOU KNOW IS TO EXPAND AND ENHANCE WOMEN'S HEALTH RESEARCH. BUT THIS OFFICE WAS FOUNDED OUT OF ADVOCACY, WOMEN IN CONGRESS SCIENTISTS AND OTHERS DEMAND IT, THAT NIH ADDRESS ISSUES RELATED TO WOMEN'S HEALTH IN A SPECIFIC WAY. IT WAS LACK OF INCLUSION OF WOMEN ROUTINELY IN CLINICAL TRIALS AND THE COROLLARY APPLICATION OF FINDINGS FROM CLINICAL TRIALS DONE IN MEN TO WOMEN AS EMPHASIS FOR THAT. I ALWAYS LIKE TO RECOGNIZE OUR LEGACY, DR. RUTH KIRSCHSTEIN, DR. BERNADINE HEELEY WHO IS -- HAS BEEN THE ONLY FEMALE DIRECTOR OF NIH AND WAS DIRECTOR FINDING THIS OFFICE, SENATOR BARBARA MCCOULD SKI FROM MARYLAND WHO RECENTLY RETIRED AND IS A TIRELESS PROPONENT OF WOMEN'S HEALTH AND DR. VIVIAN PENN FIRST FULL TIME DIRECTOR OF THIS OFFICE. SO AS WE MOVE FORWARD INCLUDING WOMEN AND THEN UNDER-REPRESENTED MINORITY GROUPS IN CLINICAL RESEARCH IS PART OF OUR DNA, PART OF WHAT WE DO. ROUTINELY. SO WE DON'T CALL THAT OUT SEPARATELY. BECAUSE WE THINK THAT'S INTEGRAL TO GOOD SCIENCE. THE THIRD PART OF OUR MISSION IS PROMOTING ADVANCEMENT. RECRUITMENT, RETENTION AND SUSTAINED ADVANCEMENT OF WOMEN IN SCIENCE. IS WHAT WE'RE TALKING ABOUT WHEN WE SAY CAREER ADVANCEMENT. AS WE DO THAT, WE HAVE PUT TOGETHER THIS TAG LINE TO CRYSTALLIZE WHAT WE DO, PUTTING SCIENCE TO WORK FOR THE HEALTH OF WOMEN. WE HAVE BEEN VERY INTENTIONAL IN PHRASING THAT, THE HEALTH OF WOMEN, BECAUSE WE WANT PEOPLE TO REALLY EVERY TIME THEY HEAR THAT RECOGNIZE WHAT WE ARE WORKING ON IS EVERYONE THAT AFFECTS A WOMAN FROM HEAD TO TOE. IS WOMEN'S HEALTH INTERPRETED AS WOMEN ALONE. WE NEED SCIENCE TO ADVANCE HEALTH OF WOMEN, THAT'S WHAT WE DO HERE. I'M THRILLED TO SHARE WITH YOU INFORMATION ABOUT SOME NEW STAFF MEMBERS AND HERE ARE THE ASSOCIATE DIRECTORS. THE FIRST IS DR. MONICA RAMIREZ VASCO, ASSOCIATE DIRECTOR OF SCIENCE POLICY PLANNING AND ANALYSIS. SHE RECENTLY JOINED FROM THE CERTAINTY FOR SCIENTIFIC REVIEW WHERE SHE RAN THE NIH EARLY CAREER REVIEWER PROGRAM. AND SERVED AS THE EXECUTIVE SECRETARY FOR THE ACD DIVERSITY WORKING GROUP SUBCOMMITTEE ON PEER REVIEW. THAT GROUP HAS BEEN EXPLORING THE REASONS FOR RACIAL DISPARITIES AND RO1 AWARDS. I KNOW MANY OF YOU ARE AWARE OF THAT WORK. FROM 2014 TO 20158 MONICA WAS ASSISTANT DIRECTOR STORE NEUROSCIENCE MENTAL HEALTH AND BROADENING PARTICIPATION AT THE WHITE HOUSE OFFICE OF SCIENCE AND TECHNOLOGY POLICY AND PRIOR TO JOINING THE FEDERAL GOVERNMENT DR. BASCO WAS ASSOCIATE PROFESSOR PSYCHIATRY AT UT SOUTH WESTERN MEDICAL CENTER AT DALLAS AND SHE IS AUTHOR OF TEN BOOKS. DR. BASCO CAN YOU PLEASE STAND SO PEOPLE CAN RECOGNIZE YOU? [APPLAUSE] >> OUR SECOND NEW STAFF MEMBER ASSOCIATE DIRECTOR IS DR. VICTORIA CARGO. SHE HERBED HER MEDICAL DEGREE FROM BOSTON UNIVERSITY AND MASSERS OF SCIENCE AND CLINICAL EPIDEMIOLOGY FROM UNIVERSITY OF PENNSYLVANIA. AND DR. CARGO HAS A LONG STANDING HISTORY OF EXCELLENT RESEARCH AND HIV AIDS AND HAS COME TO US MOST RECENTLY FROM THE OFFICE OF AIDS RESEARCH WHERE SHE HAS LED A STRATEGIC PLAN TO FOCUS THE NIH PORTFOLIO ON HIV ASSOCIATED HEALTH DISPARITIES. THIS WORK LED TO THEEEIATION OF AD HOC ADVISORY COMMITTEE, THAT PROVIDED INSIGHTS TO THE GAPS AND NIH -- IN GAPS IN THE NIH RESEARCH PORTFOLIO. AS BELL AS BASIS FOR SEVERAL COMMUNITY CONSULTATIONS HELD BY OAR. SPECIAL INTEREST IN AREA OF DISPARITIES AND HIV CARE AND RETENTION ENGAGEMENT AND RE-ENGAGEMENT; AND SHE'S CONDUCTING A STUDY OF IMPACT OF NO SHOW IMPACTED INTERVENTIONS IN CLINICAL PRACTICE SITE IN SOUTHEAST WASHINGTON D.C. DR. CARGO PLEASE STAND SO PEOPLE CAN RECOGNIZE YOU. [APPLAUSE] >> OUR THIRD NEW ASSOCIATE DIRECTOR IS DR. SHARON HUNTER. DR. HUNTER HAS OVER 23 YEARS EXPERIENCE AT NIH AND SHE EARNED HER Ph.D. IN BIOMEDICAL SCIENCES AT MOUNT SINAI SCHOOL OF MEDICINE. SHE SPENT 20 YEARS AT NIH FOCUSING ON TRAINING PROGRAMS GRANTS AND ADMINISTRATIVE SUPPLEMENTS AND POLICY WITH SPECIAL INTEREST IN NEUROSCIENCE. DR. HUNTER COMES TO US FROM SERVING AS DEPUTY DIRECTOR OF THE NATIONAL INSTITUTE ON AGINGS DIVISION OF EXTRAMURAL ACTIVITIES. AND SHE WAS TRAINING OFFICER AT NIA. SHE ALSO HAS SERVED AT THE NATIONAL EYE INSTITUTE AND NATIONAL INSTITUTE FOR DEAFNESS AND COMMUNICATIVE DISORDERS AND SHE'S CHAIR AND ORGANIZER OF MULTIPLE REVIEW COMMITTEES AND HAS BEEN INTERNALLY. I WANT TO SHARE WITH YOU THAT DR. HUNTER IS ALSO CREATOR OF A NEW MECHANISM K 76 MECHANISM FOR EMERGING LEADERS, A TRANS-NIH PROGRAM FOR CAREER DEVELOPMENT FOR CLINICIAN SCIENTISTS. ABOUT WHICH WE PARTICULARLY PROUD. DR. HUNTER PLEASE STAND SO PEOPLE CAN RECOGNIZE YOU. [APPLAUSE] >> ALL RIGHT. THIS IS THE REST OF THE CURRENT TEAM ORWH AND ALL OF THEM ARE HERE TODAY TO GREET YOU AND I ENCOURAGE YOU TO INTRODUCE YOURSELVES AND THEY WILL BE INTRODUCING THEIR -- THEMSELVES TO YOU AND AT THIS POINT I WANT TO TAKE THIS MOMENT TO ACKNOWLEDGE ALL OF THEM IN THE ORGANIZATION OF THIS MEETING, EVERY SINGLE ONE OF OUR STAFF MEMBERS HAS CONTRIBUTED IN PARTICULAR THE OPERATIONS TEAM SUPPORTED THIS MEETING, SO I DO WANT TO THANK ALL OF THEM FOR THEIR SUPPORT IN THIS -- ABSOLUTELY FANTASTIC MEETING. SO WE WILL START OFF WITH SEX AS A BIOLOGICAL POLICY. I DECIDED THE START MY TALK DIFFERENTLY THIS YEAR, I TYPICALLY START WITH TALKING ABOUT THE RESEARCH THAT WE FUNDED BUT THIS IS A SPECIAL TIME FOR SABB THAT I WANT TO START WITH THAT. AND SHARE EXCITING NEWS ABOUT OUR EXPERIENCES. AND SO THIS IS WHAT I WOULD LIKE TO CALL SABB IN A NUTSHELL. IT WAS PART OF THE POLICY STATEMENT THAT WE PUT OUT AND BECAME EFFECTIVE OVER A YEAR AGO ON JANUARY 25th, 2016. NIH EXPECTS THAT SEX AS A BIOLOGICAL VARIABLE WILL BE FACTORED INTO RESEARCH DESIGNS ANALYSIS AND REPORTING IN VERTEBRATE ANIMAL AND HUMAN STUDIES. THAT'S IT IN A NUTSHELL. WHAT WE HAVE SEEN IS THIS HAS GOTTEN US RECOGNIZED. I THINK AS I MENTION, IT'S THE POLICY THAT'S GETTING RECOGNIZED AND REALLY RESONATES WITH FOLKS. IN TERMS OF PUBLICATIONS, WE HAVE -- SORRY. WE RIGHT BEFORE THE LAST ADVISORY COMMITTEE MEETING, THERE WAS A PUBLICATION IN THE JOURNAL DESCRIBING OUR WORKSHOP CONSIDERING SEX AS A BIOLOGICAL VARIABLE IN PRE-CLINICAL RESEARCH. SUBSEQUENTLY RECENTLY WE HAD A PUBLICATION ALONG WITH DR. TANENBAUM, CANADIAN INSTITUTES FOR HEALTH RESEARCH ON TERMS SEX AND GENDER AND TRYING TO GET US ALL TO USE THEM DIRECTLY AND THINK ABOUT WHAT WE'RE DOING. AND WE ALSO -- SORRY. I HIT THE BUTTON TOO SOON THERE. WE'RE ALSO BEING RECOGNIZED WITH AWARDS AND HERE IS ONE OF THEM. THANK YOU, DR. GREEN, FOR HIGHLIGHTING THE AWARDS AND I AGAIN THIS IS THE WOMEN'S DAY AWARD AND THIS IS THE AMERICAN MEDICAL ASSOCIATION NATHAN DAVIS AWARD THAT I WAS PRIVILEGED AND HONORED TO RECEIVE THIS PAST YEAR. AGAIN, PEOPLE ARE RECOGNIZING THAT BECAUSE THISN'T ADDRESSED BEFORE -- THIS WASN'T ADDRESSED BEFORE THEY FEEL THIS NEEDS TO BE ACKNOWLEDGED AND THAT'S WHAT I BELIEVE IS RECEIVING THE RECOGNITION. WE HAVE ALSO BEEN IN THE NEWS SO THERE'S PIECES IN THE WASHINGTON PST AROUND WOMEN AND HEART DISEASE AND HEART ATTACK SYMPTOMS. AS WELL AS VARIETY OF OTHER PUBLICATIONS INCLUDING CHEMICAL AND ENGINEERING NEWS, THE SCIENTISTS AND OTHER PIECES ANTICIPATED PIECE IN THE STANFORD MEDICINE NEWS IN THE SPRING HERE AND PIECE IN THE HUFFINGTON POST BUT BASICALLY I WANT TO SHARE WITH YOU THE VARIETY OF OUTLETS THAT SABB HAS BEEN EXPOSED AND TALK ABOUT THE GROWING INTEREST IN SEX AS A BIOLOGICAL VARIABLE FROM OUR STAKEHOLDER PARTNERS. LIKE THE AMERICAN CHEMICAL SOCIETY, LIKE THE ENDOCRINE SOCIETY, AND LIKE THE VA SPONSORED SOCIETY OF FEDERAL HEALTH PROFESSIONALS WHERE I WAS PRIVILEGED TO SPEAK ABOUT SEX AS A BIOLOGICAL VARIABLE AND THEY WERE VERY INTERESTING HEARING HW NIH IS APPROACHING THIS ISSUE. SO TODAY WE THINK OF THIS SEX AS BIOLOGICAL POLICY IMPLEMENTATION AS TEAM SPORT. ALL OF YOU, I COULDN'T HAVE ASKED FOR A BETTER DAY TO HAVE ALL THESE TAR HEELS IN THE AUDIENCE ON THE COMMITTEE HIGHLIGHTING THE FACT THAT WE ALL HAVE TO PLAY OUR PART. WE DO WIN WHEN EACH PLAY OUR PART. OUR PARTS ARE DIFFERENT AND COMP HEN TEAR. SO WE ARE THRILLED TO BE ABLE TO PARTNER WITH ACADEMIA, WITH SOCIETIES AND ORGANIZATIONS WITH OUR JOURNAL EDITOR PUBLISHING COLLEAGUES WITH THE LAY PUBLIC WITH INDUSTRY, WITH MEDIA, SCIENTIFIC COLLEAGUES AND HEARING FREQUENTLY FROM OUR MEMBERS OF CONGRESS IN TERMS OF WHAT THEY EXPECT THAT WE ARE DOING AND TERMS OF RESPONSIBLE STEWARDSHIP OF THE FUNDS THAT ARE PUT FORWARD FOR NIH SPONSORED RESEARCH. I WILL PAUSE A SECOND AND REMIND HOW WE GOT HERE. IT'S EXCITING TO BE ABLE TO SHARE WHERE WE ARE BUT IT IS CRITICALLY IMPORTANT TO REMEMBER HOW MUCH IT TOOK TO GET HERE. I RECOGNIZE THE LEGACY OF PEOPLE THAT FORM THIS OFFICE AND I WANT TO ALSO ACKNOWLEDGE THE INCREDIBLE NETWORK OF SEX DIFFERENCES RESEARCHERS WHO HAVE BEEN ADVOCATING FOR ADDRESSING SEX AS BIOLOGICAL VARIABLE FOR SOME TIME SO MY PRIVILEGE TO BE ABLE TO BE THE ONE TO PUSH THAT OVER BUT IT IS THE WORK OF MANY, MANY INDIVIDUALS. OF HIS THAT NEEDED IN -- WHY WAS THAT NEEDED? THERE WAS CLEARLY AN OVERRELIANCE ON MALE ANIMALS AND CELLS IN BASIC SCIENCE RESEARCH. THERE'S CLEARLY AN INATTENTION TO INFLUENCE IT IS OF SEX AND GENDER AND HEALTH AND DISEASE. AND THERE'S LACK OF TRANSPARENCY REPORTING THE SEX OF SUBJECTS IN STUDIES, BE THEY ANIMALS, OR HUMANS FOR THAT MATTER. IN TERMS OF SEX SPECIFIC RESULTS. WE KNOW THERE'S -- I WILL CALL IT A PERVASIVE PAUCITY OF SEX SPECIFIC RESULTS IN SCIENTIFIC PUBLICATIONS THROUGHOUT THE ENTIRE RESEARCH CONTINUUM, THIS CONTINUES FROM THE MOST BASIC TO THE MOST CLINICAL WHERE WE STILL DO NOT ROUTINELY SEE, WE SEE A TABLE ONE WE KNOW WHO IS IN THE STUDY FOR CLINICAL STUDIES BUT WE DON'T SEE THE RESULTS FOR THE PRIMARY OUTCOMEDIES AGGRAVATED BY SEX. -- AGGREGATED FOR SEX. FEWER THAN A THIRD PUBLICATIONS FROM NIH FUNDED PHASE 3 CLINICAL TRIALS HAVE ANY SEX SPECIFIC RESULTS OF ANY SORT. P SO THAT'S HOW WE GOT HERE. WHAT WAS -- WHAT'S THE CONSEQUENCE OF THAT? WE HAVE AN INCOMPLETE I LIKE TO SAY KNOWLEDGE BASE ABOUT MALE AND FEMALE BIOLOGY, IT'S INCOMPLETE. YOU CAN'T ARGUE THAT IF YOU DON'T KNOW WHAT SEX CELLS ANIMALS IN A STUDY THAT YOU HAVE ANYTHING CLOSE TO A COMPREHENSIVE UNDERSTANDING. SO IT'S INCOMPLETE. WE ALSO HAVE A SITUATION AS I MENTION WE DON'T HAVE FUNDINGS FROM STUDIES WE SUPPORTED THAT HAVE BEEN INVESTED FOR MANY YEARS. SO I SAY THAT WE HAVE MISSED OPPORTUNITIES TO MAXIMIZE OUR RETURN ON INVESTMENTS WE HAVE MADE. TO LEARN EVERYTHING WE CAN FROM EVERY RESEARCH DOLLAR THAT IS SO PRECIOUS ESPECIALLY NOW. SO WE NEED AD POLICY. CLEARLY THERE WAS ADDITIONAL WORK NEEDED TO PUSH THIS OVER AND FOR US TO PAY MORE ATTENTION AS BIOMEDICAL RESEARCH COMMUNITY. SO WE ARE MOVING THE PHASE 2 SEX AS A BIOLOGICAL VARIABLE POLICY. DR. COLLINS AND I INITIATING THIS IN NATURE PIECE MENTION THIS WOULD BE A PHASED APPROACH. WE RECOGNIZE THAT THE SCIENTIFIC COMMUNITY THAT THIS WOULD BE A BIG CHANGE AND WE WANT TO DO THIS IN A THOUGHTFUL WAY. WE'RE NOW IN WHAT WE CALL PHASE 2. WHERE POLICY HAS BEEN LAUNCHED BUT WE NEED TO TURN THAT POLICY IN TO PRACTICE. TO DO THAT, WE CHOOSE AN APPROACH OF INTENTIONAL INTEGRATION, OF CONSIDERATION OF SEX AND GENDER INFLUENCES, ON HEALTH AND DISEASE, THROUGHOUT THE ENTIRE RESEARCH CONTINUUM. I WILL SHOW YOU WHAT I MEAN. START WITH THE MOST BASIC SCIENCE, WE SOMETIMES CALL THAT BASIC BASIC SCIENCE, BASIC WORK, I'M SEEING SMILES AROUND THE TABLE. THIS MAY BE EXPLORATORY. TRYING TO UNDERSTAND SOMETHING IN NATURE. YOU MAY NOT HAVE A HYPOTHESIS, IT MAYBE HYPOTHESIS GENERATING. HERE WHAT WE ARE ASKING PEOPLE TO DO AND WHAT WE SAID CLEARLY IN THE GUIDE NOTICE IS THAT CONSIDERATION OF SEX AS A BIOLOGICAL VARIABLE BEGINS WITH DEVELOPING THE RESEARCH QUESTION AND AN APPROPRIATE EXPERIMENTAL DESIGN FOR THAT RESEARCH QUESTION. WHAT'S SABB MAY LOOK LIKE IN THE BASIC BASIC WORLD IS OBSERVING WHAT YOU SEE IN REPORTING THE SEX OF THE ANIMAL OR SUBJECT OR CELLS OR WHATEVER CONTEXT SUBSTRATE YOU SEE IT IN. IT MAYBE NOTHING MORE THAN THAT. NOW, WHEN YOU MOVE INTO THE PRE-CLINICAL SPACE, THIS IS DIFFERENT. WE AGREE BASIC SCIENCE AND PRE-CLINICAL STUDIES ARE DIFFERENT. YOU DECLARED A PURPOSE BY SAYING IT'S A PRE-CLINICAL STUDY. PRE-CLINICAL. YOU'RE MOVING TO THE CLINIC. OR YOU'RE MODELING A HUMAN CONDITION. THESE ARE MODELS OF HUMAN DISEASE THOUGH WE KNOW THEY DON'T RECAPITULATE HUMAN DISEASE, YOU KNOW # HUNDRED% THAT'S YOUR PURPOSE. IF YOUR PURPOSE IS TO MOVE INTO CLINIC AND THE DISEASE YOU STUDY AFFECTS MEN AND WOMEN, YOU NEED TO ACCOUNT FOR SEX AS A BIOLOGICAL VARIABLE. HOW YOU DO THAT MAY VARY. BASED ON WHAT IS KNOWN IN THAT AREA. BUT I WILL GIVE YOU AN EXAMPLE OF FACTORIAL DESIGN MIGHT BE ONE APPROACH WHERE YOU CAN LOOK AT EFFECTS OF SEX AS WELL AS YOUR OTHER INTERESTS. AS YOU MOVE TO TRANSLATION INTO CLINICAL RESEARCH, AGAIN, THAT TO ME IS A HARD CHECK POINT. YOU ARE MOVING TO THE CLINIC, THEY'RE FIRST IN HUMAN STUDIES, YOU'RE TRYING TO IDENTIFY A TARGET, TEST THERAPEUTIC AGENT. YOU HAVE A HYPOTHESIS, IT NEEDS TO BE TESTED IN WAY THAT ACCOUNTS FOR SEX AS A BIOLOGICAL VARIABLE APPROPRIATELY AND WE NEED TO UNDERSTAND IF THERE ARE CONCERNS ABOUT SAFETY THAT MIGHT BE RELEVANT FOR MEN AND WOMEN BEFORE WE DO OUR FIRST IN HUMAN STUDIES. WE NEED TO UNDERSTAND IF THERE MIGHT BE CONCERNS ABOUT DOSAGE AND EFFICACY AND WE ARE EXPLORING THAT IN CLINICAL STUDIES BUT WE NEED DUE DILIGENCE, EXPLORING EVERYTHING WE CAN BEFOREHAND. WE KNOW WHAT HAS HAPPENED WHEN OUR CLINICAL MODELS DON'T COME CLOSE ENOUGH TO THE HUMAN DISEASE. WE ARE AWARE OF DECEMBER APPOINTMENTS -- DISAPPOINTMENTS AROUND MANY AGENTS THAT DO NOT FULFILL THEIR PROMISE AND THEN WORSE, ADVERSE OUTCOMES THAT WERE SURPRISES BECAUSE THE MODEL REALLY WASN'T CLOSE ENOUGH TO THE HUMAN CONDITION. AS WE MOVE FROM CLINICAL TRIALS INTO THE SPACE OF IMPLEMENTATION SCIENCE WHERE WE TRY TO TAKE THAT FINDING FROM OUR RANDOMIZED CLINICAL TRIAL TO REAL WORLD, THERE GENDER ALSO COMES INTO PLAY BECAUSE WE KNOW MEN AND WOMEN DO NOT OPERATE THE WAY WE'RE IN A CLINICAL TRIAL. IN REAL LIFE. NONE OF US HAS A LIFE LIKE THAT. ND THERE MANY FACTORS THAT -- IF WE SEE SOMETHING, I WONDER IF THAT'S A SEX CHROMOSOME ISSUE THERE, YOU CAN DESIGN A STUDY THAT GOES BACK TO THE ANIMAL MODEL, TO TEST THAT OUTS. SO WE WANT YOU TO THINK OF SEX AS BIOLOGICAL VARY YUM ALONG THE RESEARCH CONTINUUM AS APPROPRIATE AND INCORPORATE INTO DESIGN ANALYSIS AND REPORTING OF YOUR RESULTS IN YOUR PUBLICATIONS AND PROGRESS REPORTS AND IN YOUR PRESS RELEASES. AS THIS INFORMATION CONTINUES TO BE INTEGRATE AND GROWS IT WILL TRICKLE OUT THROUGH HEALTH EDUCATION, HEALTH POLICY AND ULTIMATELY SO WE CAN DELIVER SEX AND GENDER APPROPRIATE CARE TO EVERY PATIENT. THAT RANGE FROM CHURCHES TO LARGE NATIONAL NOT FOR PROFITS WHO HAVE A LOT OF LOCAL PRESENCE SO THEY CAN BE THE FACE OF OUR PROGRAM LOCALLY TO THESE OTHER COMMUNITIES WHERE WE DON'T HAVE A HEALTH PROVIDER ORGANIZATION. SO ALL THOSE PIECES COMING TOGETHER, THERE'S ABOUT 63 MEMBERS OF THE WHOLE CONSORTIUM AT THIS POINT IN TIME WITH OUR 20 PEOPLE AND OUR STAFF TRYING TO CARRY IT FORWARD. IT'S BEEN CHALLENGING HARDER THAN RUNNING A MULTI-BILLION DOLLARS BIDS FOR CORPORATION IN SILICON VALLEY, TELL YOU. I KEEP TELLING MY FRIENDS YOUR NOTION OF WHAT GOVERNMENT WORKERS DO IS COMPLETELY WRONG. WE'RE WORKING NIGHT AND DAY SO THIS IS MAJOR AWARDS AROUND THE COUNTRY YOU SEE RNC OR REGIONAL MEDICAL CENTERS THAT INCLUDES FEDERALLY QUALIFIED HEALTH CENTERS, SIX PILOT, TWO HAVE DONE RESEARCH BEFORE BUT THE OTHER FOUR HAVEN'T IS WEAR TRYING TO HELP THE HEALTH CENTERS BUILD RESEARCH CAPACITY IN THIS PARTICULAR INSTANCE BUT DISRUPTIVELY POSITIVE WAY WE HOPE IT HELPS OPEN UP TO DO RESEARCH IN OTHER CONTEXT AND SO FORTH. SO THIS IS A DIFFERENT WAY OF THINKING ABOUT CURRENT MEMBERS, PEOPLE WONDER HOW WE DO THE DIRECT VOLUNTEER PIECE SO EVERYBODY ABOVE THE LINE DIRECT VOLUNTEER, YOU SEE WALGREENS, FOLKS LIKE QTC, THE NATIONAL BLOOD COLLABORATIVE, THAT'S HOW WE'RE GETTING PHYSICAL MEASUREMENTS AND BLEW DRAWS AND URINE SPECIMENS THROUGH SCATTERED THROUGHOUT THE COUNTRY. WE DON'T IMMEDIATELY HAVE FULL COVERAGE OF THE COUNTRY, IT RAMPS IN CITIES AND THEN REGIONS AND THEN IN RURAL AREAS AN RAMPS ACROSS THE COUNTRY OVER TIME. THEN YOU CAN SEE THE HEALTH PROVIDERS ORGANIZATIONS AND MANY OF THE OTHER KEY PLAYERS LIKE COMMUNICATIONS FIRMS THAT ARE HELPING US DO THIS. IT TAKES QUITE A VILLAGE. NOTHING HAS BEEN DONE AT THIS SCALE, THERE'S OTHER MILLION PERSON COHORT STUDIES BUT NOT TRYING TO ACHIEVE DIVERSITY OF PEOPLE, JOG I IF, DIVERSITY -- GEOGRAPHY, AND DATA TYPES WE CAPTURE BECAUSE WE WANT BIOLOGICAL CLINICAL DATA BEHAVIORAL DATA, ENVIRONMENTAL DATA BROADLY CONSTRUED TO BE PULLED INTO THOSE DATA SETS SO WE CAN START TO UNDERSTAND WHAT IS THE INNER ANIMATION OF DATA TYPES THAT ARE USEFUL TO HELP US UNDERSTAND HOW INDIVIDUALS ARE GOING TO RESPOND TO THINGS THAT HAPPEN IN THEIR LIFE THAT UNFOLDED IN THE FUTURE. IT'S IMPORTANT TO UNDERSTAND, I WILL -- IF YOU THINK ABOUT THE WAY WHICH PEOPLE GET EXCITED ABOUT THE NEXT RELEASE OF IPHONE OR ANDROID PHONE, I MEAN, I WORK IN TECH FOR 25 YEARS AND I COULDN'T CARE LESS BUT IT'S LIKE OKAY NEXT PHONE, I HAVE TO FIGURE HOW TO USE IT BUT NONETHELESS PEOPLE GET EXCITED, AND REALIZE WE'RE NOT DOING A ONE TIME BIOSAMPLE COLLECTION, WE'RE NURTURING AN ONGOING RELATIONSHIP AND SETTING UP CONSENT IN A WAY THAT THEY WILL BE ONGOING SURVEYS THAT EVERY TWO TO THREE YEARS WE WILL DO A MAJOR NEW PROTOCOL RELEASE, THERE WILL BE LITTLE RELEASES ALONG THE WAY WHERE WE CAN ADD NEW PHYSICAL MEASUREMENTS, WE CAN ADD NEW -- DOING BLOOD AND URINE IN VERSION ONE, HAIR, FINGERNAILS AND OTHER BIOSAMPLES AN ADDITIONAL BLOOD TO MAKE THOSE RESOURCES AVAILABLE TO RESEARCHERS AROUND THE COUNTRY. SO IT'S -- PEOPLE COME TO ME LIKE YOU HAVE TO GET EVERYTHING BUT KITCHEN SINK IN VERSION ONE, LIKE NO WE DON'T. WE WILL WEIGHT IT DOWN WITH SO MUCH IT CAN'T GET OFF THE GROUND. WE'RE DOING BASIC THINGS FOR VERSION ONE THEN WE'LL DO A SERIES OF SCIENTIFIC WORKSHOPS WITH PARTNERSHIPS WITH THE ALL THE ICs AND BRINGING IN OUTSIDE FUNDERS FOR THE COMMENT EARLIER TO SAY HOW WE COLLECTIVELY CREATE A ROADMAP OF SCIENTIFIC FOCUS AREAS, WE WANT TO MAKE SURE ARE BAKED IN AT THE SECOND RELEASE. THE THIRD RELEASE. THE FOURTH RELEASE. THE FIFTH REALS, SO FORTH. SO QUICK STATUS UM DATE, I'M GOING FAST BECAUSE I HAVE TO LEAVE PROMPTLY AT 10:30. SO THE CURRENT STATUS WE BUILT THE NETWORKS. ALL THE LOGOS ON THE SLIDES THOSE ARE REAL PEOPLE. WE ARE IN THE THROWS OF THE FINAL IRB APPROVAL OF OUR VERSION 1 PROTOCOL AND CONSENT, WHICH IS A COMPLICATED THING TO DO. WE'RE TRYING TO DO EVERYTHING IN FIFTH GRADE READING LEVEL SO IT'S TAKEN EFFORT TO TAKE TRADITIONAL SURVEYS THAT OTHERS HAVE DONE AND PUSH THAT LANGUAGE DOWN TO WHERE EVEN MORE PEOPLE CAN TAKE THOSE SURVEYS. AND ENORMOUS AMOUNT OF TESTING AND USING TESTING OF EVERYTHING FROM THE SECURITY TO THE INTERFACES, TO THE LANGUAGE THAT WE'RE USING AND EVERYTHING FROM MARKETING MATERIALS DOWN TO SURVEY INSTRUMENTS THEMSELVES. BUILDING THE 1800 NUMBER, SMART PHONE APPINGS ARE READY FOR ANDROID AND iPHONES AS WELL AS WEB AND END TO END SECURITY TESTING. IMAGINE WHAT A HACKING TARGET WE WILL BE BRINGING IN BEST IN CLASS METHODS FROM OTHER PARTS OF GOVERNMENT AND INDUSTRY AND GOING THROUGH RIGOROUS TESTING PROCEDURE. NO WORSE WAY TO LOSE TRUST THAN RIGHT OUT OF THE WAY HAVING ATTACK BUT YOU ALSO HAVE TO BE HONEST WITH PEOPLE THERE'S NO SUCH THING AS FOOLPROOF, HERE IS WHAT WE DO IF THINGS FAIL, HERE ARE THE VARIOUS RISKS ASSOCIATED WITH THAT. ESTIMATE OF TARGET DEMOGRAPHICS AND GEOGRAPHY AT LAUNCH. WE'RE GOING TO CHANGE OVER TIME. IMAGINE HEALTH PROVIDERS ORGANIZATIONS AND OTHERS CHOSEN BASED ON WHAT THEY TOLD US THEY COULD RECRUIT IN TERMS OF DIVERSITY. SO THEY HAVE KNOWN THIS FROM GOING IN BUT NOW AS WE GET CLOSER TO TIME, THEY'RE LIKE CAN WE TAKE WHOEVER WE GET AT FIRST, LIKE NO, THE BETA PHASE WE WILL GO IN FOUR TO SIX MONTHS IS TO TEST YOUR RECRUITMENT METHODS TO ACHIEVE REACHING THOSE DIVERSE COMMUNITIES. WE WILL BE DIVERSE FROM THE BEGINNING, MAKE MISTAKES BUT CAN'T JUST TAKE WHOEVER COMES IN BECAUSE WE WILL ENDS UP LOOKING AND FEEING LIKE ALL OF THE OTHER RESEARCH STUDIES DONE TO THIS POINT. THAT YOU KNOW THE PROBLEM OF MORE DEEPLY THAN REST OF RESEARCHERS AND THE,NANAL INSTITUTES OF HEALTH. SO OVER RECRUITING, AND WE'LL GET THERE ON SOME OF THE ONES WE AREN'T OVERRECRUITING DIFFERENT RACIAL AND ETHNIC GROUPS BUT THEN 75% WHEN YOU ADD IN RURAL AREAS WOMEN, THIS BIG CATEGORY. WE WANT TO MAKE SURE 75% WE'RE STILL FIGURING WHAT WE MEAN AND HOW TO ACCOUNT AND TRACK UNDER-REPRESENTED BIOMEDICAL RESEARCH. WE'RE INTERACTING JUST STARTING TO INTERACT WITH OTHER INSTITUTES TO HELP GET THAT DEFINITION DONE. BUT WE'RE DARN SERIOUS ABOUT THE DISTRESSORTY AND WE'RE GO -- DIVERSITY AND WE WILL LEARN HOW TO DO IT OVER PERIOD OF TIME. SO THE PROTOCOL IS BASICALLY CONSENT IN eCONSENT MODULE, WE CAN DO THINGS ON PAPER BUT TRYING TO PUSH AS MUCH TO CONSENT. I -- SIX GRADE READING LEVEL THINKING ABOUT WHAT WE CAN DO TO FIFTH GRADE. ENGLISH AND SPANISH AND WE'LL ADD OTHER LANGUAGES AS WE GO FORWARD. YOU HAVE TO START WITH SOMETHING AND THEN ADD DIFFERENCE RELEASES OF DIFFERENT PROTOCOLS OR DIFFERENT PLATFORMS IN TIME. GIVING CONSENT TO SHARE EHR DATA, THEY UNDERSTAND IT'S LONGITUDE TALL AND WE'LL EVENTUALLY DO GENETICS BUT GET RECKON SENTENCED ON THE LOCAL THINGS -- RE-CONSENTED CLOSER TO TIME. A SEPARATE OPT-IN SIGNATURE. IMAGINE DOING THINGS NATIONAL SCALE WITH ALL THE VARIOUS DIFFERENT STATE LAWS AN RULES, IT'S CHALLENGING. THESE ARE THE INITIAL THREE ENROLLMENT SURVEYS, BASELINE SURVEYS SO CONTACT AND SOCIO DEMOGRAPHICS OVERALL HEALTH AND MENTAL HEALTH AND PERSONAL HABITS AND IT DOES INCLUDE SOME SUBSTANCE USE AND MANY EXPERTS AROUND THE COUNTRY HELPED TO INFORM THESE. WE'RE NOT REINVENTING THE WHEEL, WE'RE BEGGING AND BORROWING FROM INSTRUMENTS WELL TESTED AND TRIED THOUGH WITH ARE FINDING MANY OF THOSE HAVE NOT BEEN WELL TESTED AND TRIED WITH DIVERSE COMMUNITIES SO IT'S TAKING REWORK OF THOSE AS WE GO FORWARD. AND THESE ADDITIONAL ONES IN DEVELOPMENT PERSONAL HEALTH HISTORY MEDICATION FAMILY HISTORY, GETTING DARN CLOSE, WE JUST DIDN'T WANT TO LOAD UP THE IRB, JUST NEED INITIAL THREE SO WE CAN GET STARTED IN THESE WILL COME IN FAIRLY QUICKLY. AS WE START TO DO THAT SCIENTIFIC WORKSHOPS WE WILL START TO DEVELOP INSTRUMENTS THAT CAN SERVE MULTIPLE MASTERS. SO I'M GOING TO REACH OUT TO LOTS OF DIFFERENT FIELDS AND HAVE THEM HELP INFORM THE SCIENCE OF WHAT WE CAN DO. BUT ULTIMATELY I'M TRYING TO GET EVERY OUNCE WORTH OF TAXPAYER DOLLAR, WE'LL FUND COHORT WIDE INSTRUMENTS THAT HAVE IMPACT ON AT LEAST MULTIPLE PEELED FIELDS OF SCIENCE, THE WAY -- WE INITIALLY THOUGHT WE'LL HAVE PA SEPARATE WORKSHOP ON YEAR-END E SEPARATE ON AGE, WE'RE LIKE NO. THE ISSUES OF AGE AND ETHNICITY AND ISSUES OF SEX AND GENDER EMBEDDED AS PART OF THE QUESTIONS IN EVERY FIELD WE'RE STARTING TO DO SO THAT'S THE APPROACH TO TAKING TO THESE WORKSHOPS. BUT THEN FACTORING OUT SAYING MENTAL HEALTH WANTS A PHYSICAL MEASUREMENT THAT DOES THIS, CHRONIC CARE MANAGEMENT FOR DIABETES WANTS TO MEASURE LIKE THIS. THEY'RE SIMILAR. LET THEM FIGHT OUT THE IDEA LOGICAL WARS AN SCIENTIFIC WARS AND LOOK FOR PLACES WE CAN DO ONE MEASUREMENT THAT'S GOING TO SERVE MULTIPLE FIELDS. OTHERWISE IF IT'S VERY SPECIFIC THAT WOULD BE INVITING SOMEBODY TO PROPOSE ANCILLARY STUDIES TO FUND THAT ON A SPECIFIC PART OF THE COHORT AS WE GO FORWARD. SO WE'LL TRY TO GIVE AS MUCH DATA AND AS MUCH ASSAY AS POSSIBLE. BUT BIOSAMPLES AND EVENTUALLY COHORT ITSELF BECAUSE PEOPLE WANT TO BE AVAILABLABLE TO DO SUBSTUDIES AND BE INVITED TO DO THAT. THAT ARE RELEVANT TO THEIR PARTICULAR HEALTH CONDITIONS, SO FORTH. VERSION ONE DOES SIMPLE MEASUREMENTS BLOOD PRESSURE BMI HEART RATE, HEIGHT, HIP AND WAIST CIRCUMFERENCE AND WEIGHT AND BIOSPECIMEN COLLECTION IS BLOOD, SPIT IF THEY CAN'T ACTUALLY -- GET BLOOD AFTER A CERTAIN NUMBER OF STICKS. 35 ALLOQUATS IN THE BIOBANK AND 24 HOUR CAREER NATIONWIDE. SO ALL THESE SYSTEMSES, BACK IN SYSTEMS THAT TEST THIS AND TRAINING THE STAFF, ALL OF THAT IS HAPPENING NOW WITH WATER IN THE TUBES BECAUSE UNTIL WE HAVE OUR PROTOCOL WE CAN'T ACTUALLY START TESTING WITH REAL BLOOD AND REAL DATA COMING THROUGH FROM THOSE SYSTEMS, IT'S IMMINENT. EHR DATA I CAN SPEND AN HOUR ON THIS, IT'S EASY, THE HEALTH PROVIDER ORGANIZATIONS INCLUDING THE FQHCs WHO SIGNED UP HAD TO DO A DIGITAL SPRINT WITH US TO SHOW THEY COULD SEND THE DATA WE WANT INITIALLY AS PART OF THE REVIEW PROCESS. THE DIRECT VOLUNTEER PATH IS A LOT MORE COMPLICATED. WE HAVE A LONG-TERM EFFORT WITH OFFICE OF NATIONAL COORDINATOR AND SEVEN OF THE EIGHT LARGEST EHR VENDORS IN THE COUNTRY ON THE SYNC FOR SCIENCE PROGRAM, IT'S A CAPABILITY THAT WILL HELP US BUT HELP EVERYBODY ONCE IT ROLLS OUT. WE'RE DOING PILOTS OF THAT WITH ALL THE VENDORS NOW. BUT IT WILL TAKE A COUPLE OF YEARS UNTIL THIS SOFTWARE CAPABILITIES THAT MAKE IT EASY FOR A PATIENT TO WALK IN AND SAY I WANT TO BE ABLE TO DONATE MY MONEY, PRESS A BUTTON HERE. MY DATA, WHICH IS MONEY, HERE. GOOD SLIP, RIGHT? BE ABLE TO DO THAT AND HAVE THAT CAPABILITY ROLL OUT TO ALL OF THE EHRs SO THAT'S A CAPABILITY THAT'S UNDERWAY. PPI IS PARTICIPANT PROVIDED INFORMATION, THESE ARE OTHER THINGS WE'RE LOOKING AND THINKING ABOUT, BUT THESE WILL BE IMIDED BY THESE WORKSHOPS THAT WE DO NATIONALLY TO HELP PULL IN EXPERTISE TO FIGURE OUT EVERYBODY WILL COME AND SAY THEY WANT EVERYTHING FOR THEMSELVES BUT HOW DO WE FACTOR ACROSS ALL OF THOSE, FOR SOME COMMON INGREDIENTS WE CAN BAKE INTO THE PIE GOOD FOR RESEARCH FIELDS AS POSSIBLE AS WE GO FORWARD IN TIME. I WILL END ON THIS, AND SAY I MENTION AS YOU THINK ABOUT WORKSHOPS, DR. CLAYTON IS HELPFUL FOR THINKING HOW TO ASK QUESTIONS ABOUT SEX AND GENDER AND THE LATEST WAYS THAT ARE DONE. IT IS CLEAR THAT WE ARE SORT OF HOPEFULLY SHINING EXAMPLE OF THE NEW POLICY THAT YOU'RE TRYING TO DO BECAUSE WE'RE INSISTING UPON OUT OF THE GATE. AND AS WE DO THESE WORKSHOPS WHAT WE'LL BE ASKING PEOPLE TO DO IS HELP THINK WHAT ARE LOW HANGING FRUIT QUESTIONS OR MEASURES FOR WHICH THE SCALE OF ALL OF US COULD ACCELERATE FLOG AND BREAK THROUGHS IN YOUR FIELD. NOT THE RIGHT TOOL FOR THE JOB FOR CERTAIN KINDS OF QUESTIONS. WE KNOW A MILLION IS NOT ENOUGH FOR CERTAIN OTHER SCIENTIFIC QUESTIONS. WHAT MIDTERM KINDS OF QUESTIONS MIGHT THIS PROGRAM ANSWER WHERE ADDITIONAL WORK YOU MIGHT HAVE AN IDEA OF WHAT THE QUESTIONS ARE AND WHAT THE MEASURES MIGHT BE BUT YOU HAVE THE CHOOSE AMONG AN FIGHT THE SCIENTIFIC IDEA LOGICAL BATTLES SAYING WHAT'S THE AFFORDABLE WAY AT SCALE. EVERYBODY IS LIKE DO THIS FOR PEOPLE THAT ONLY COST $100 A PERSON, I'M LIKE THAT A HUNDRED MILLION DOLLARS. EVERYTHING IS TIME AS MILLION SO THAT'S PART OF THE CHALLENGE IS HOW TO SCALE THIS AND ANTICIPATE THE COST CURVES TO BE ABLE TO DO AS MUCH OF THIS AS POSSIBLE. AND LONG TERM WHAT KINDS OF QUESTIONS COULD RESOURCE LIKE THIS POTENTIALLY ANSWER? BUT NO IDEA HOW TO MEASURE IT YET. THAT'S THE PROCESS WE WILL GO THROUGH WITH THE SCIENTIFIC COMMUNITIES SO WE CAN START TO LAY OUT A YEAR IF NOT 25 YEAR ROADMAP OF THINGS WE WANT TO ANSWER. TAKE FIVE OR SIX MINUTES OF QUESTIONS THEN I WILL DASH ACROSS TOWN TO DO THIS AGAIN. [APPLAUSE] >> WONDERFUL PRESENTATION. VERY EXCITING PROJECT. WE'RE IN THE MIDDLE RIGHT NOW MY TEAM OF RECRUITING THOUSANDS OF WOMEN INTO AN HIV PREVENTION CLINICAL TRIALS TARGETING YOUNG URBAN BLACK WOMEN 18 TO 19. OUR CHIEF MECHANISM OF RECRUITMENT IN THE ENTIRE STUDIES ON LINE, THE INTERVENTION IS ON LINE, THE SURVEYS ARE ONLINE, OUR FOLLOW-UP LONGITUDINAL IS ONLINE. AND WE ARE RECRUITING VIA FACEBOOK. AND WE ARE FINDING THAT FOR YOUNG URBAN WOMEN THIS IS A VERY IMPORTANT RECRUITMENT TOOL SO WE HAVE ALREADY SCREENED FOR HIGH RISK BECAUSE ONLY HIGH RISK WOMEN ARE ALLOWEDDED TO THE STUDY, THOUSANDS OF WOMEN AND HAVE HUNDREDS OF WOMEN ENROLLED. SUNDAY NIGHT WE HAD 22 HIGH RISK WOMEN COME THROUGH, 11 WHOM SIGNED UP FOR THIS RANDOMIZED CONTROL TRIAL. WHAT I WANT TO EMPHASIZE -- THAT'S NOT TRUE FOR ALL GROUPS FACEBOOK IS NOT AS POPULAR ANY MORE FOR MEN WITH SEX WITH MEN, IT'S VERY IMPORTANT TOOL. ONE OF THE OTHER -- I MENTION THIS BECAUSE WE HAVE AN ADAPTIVE WEB DESIGN SO WE'RE ABLE TO REACH VERY DIFFERENT SMART PHONE DEVICES ALSO. WE DON'T HAVE APPS WE USE ADAPTIVE WEB DESIGN. ONE EXCITING THING WE NOTICE, WE'RE ONLY IN THREE STATES, NEW YORK, NEW JERSEY, MASSACHUSETTS. IS THAT WE ARE FINDING CLUSTERS OF NEW RECRUITS VIA FACEBOOK, PEOPLE ARE TELLING THEIR FRIENDS, SO I ANTICIPATE AT SOME POINT WE WILL ALSO AND SHOULD ALSO DO A SOCIAL NETWORK ANALYSIS. I THINK WITH THE BODY OF DATA THAT YOU ARE COLLECTING IN THE FUTURE YOU WILL FIND THIS WILL SPREAD ON ITS OWN IN TERMS OF DISSEMINATION SCIENCE IT WILL BE WONDERFUL TO ANTICIPATE SOCIAL NETWORK ANALYSIS TO SEE HOW DATA COLLECTION SPREADS ON ITS OWN AMONG POPULATION. >> WILL YOU SEND ME YOUR NAME TO ERICDISHMAN.NIH.GOV? I WANT TO TALK TO YOU MORE. >> THANK YOU FOR ACKNOWLEDGING NURSES. Q. ENGINES OF HEALTHCARE, 27 FIELD COUNTRIES I HAVE DONE WORK IN. >> SO EXCITING. I'M SITTING HERE RIVETING WITH THIS. >> WE ARE A LITTLE OVERWHELMED TO BE HONEST. IT SOUNDS GOOD BUT WE'RE OVERWHELMED. >> I WOULD BE OVERWHELMED AS WELL BUT STILL SO EXCITING. AND SOME OF THE THINGS THAT LOOKS LIKE YOU'RE GOING TOABLE REALLY THINKING ABOUT SOCIAL DETERMINANTS OF HEALTH AS WELL. SO I WAS CURIOUS HOW TO EXPAND UPON THAT, AS A PSYCHIATRIST, THAT'S OBVIOUSLY VERY NEAR AND DEAR TO MY HEART. >> PARDON THE INTERRUPTION. YOUR CONFERENCE CONTAINS LESS THAN THREE -- >> IT DOESN'T. THERE'S A LOT MORE PEOPLE HERE. TECHNOLOGY IS STUPID. IN TERMS OF SOCIAL DETERMINANTS OF HEALTH ONE BIG PEACE OF THAT AWARD WENT -- PIECE OF THAT AWARD THAT WENT TO SCRIPTS THE PARTICIPANT TECHNOLOGY CENTER IS THEY HAVE THE MOST HISTORY IN THE COUNTRY, I WORKED WITH THEM BACK AT INTEL. I DID THE FIRST WEARABLE STUDY TO START TO COLLECT ACTIVITIES OF DAILY LIVING INFORMATION ON FRAIL SENIORS 17 YEARS AGO, THE FIRST TIME I MET MIA BECAUSE I KEPT TELLING THEM I'M FUNDING MORE THAN YOU ARE AND THERE'S A WORLD OF WEARABLES TO HELP YOU HAVE INSIGHT TO BEHAVIOR IN A WAY YOU NEVER HAD BEFORE, THAT'S HOW I GOT TO KNOW FRANCIS BECAUSE I WENT SCREAMING YOU NEED A COHORT, 10,000 SENIORS TO INVENT AND TEST THESE IDEAS. SO THEIR TASKED WITH IN PARTICULAR HELPING THINK THROUGH ANTICIPATE WHERE TECHNOLOGY IS GOING THAT WE CAN MAKE AVAILABLE TO HELP US UNDERSTAND BEHAVIOR AND COMBINE WITH GEOSPATIAL DATABASES AN THINGS LIKE THAT IN SOME POWERFUL WAYS. BUT ALSO TRYING TO MAKE SURE YOU DON'T HAVE TO BE DIGITAL LISA SRI TO PARTICIPATE. IT'S HARDER FOR US, THERE'S METHODS WE WILL BE TRYING TO DO. BUT IT'S DEAF ANILY PART -- POTENTIAL OF THOSE IS ENORMOUS. >> ANGELA FIRST. >> THANK YOU SO MUCH FOR YOUR PRESENTATION. I HAD A QUESTION FOR YOU ABOUT THE 75% OF UNDER-REPRESENTED GROUP THAT INCLUDED WOMEN. DO YOU HAVE CERTAIN TARGET FOR RECRUITMENT OF WOMEN? >> WE'RE WORKING ON IT BUT WE HAVEN'T DONE IT YET BECAUSE PARTLY TRYING TO IRON OUT THIS DEFINITION WHAT WE MEAN BY UNDER-REPRESENTED. WE STARTED WITH RACE AND ETHNICITY AS A PRIMARY VARIABLE. NOW STARTING TO LAYER IN AGE PIECE AND SEX AND GENDER PIECE AND WE DON'T -- I SAID DR. MURRAY WHO HAS FAR MORE EXPERIENCE THAN SOCIAL SCIENCE INDUSTRY DOES, I'M WORRIED TO GET INTO A SITUATION IT'S IMPOSSIBLE TO RECRUIT VARIABLES. BUT WE DEFINITELY WILL OVERRECRUIT SIGNIFICANTLY ON WOMEN BASED ON EVERYTHING WE'RE TRYING TO DO, DON'T KNOW WHAT THE NUMBERS ARE BECAUSE WE WANT TO MAKE SURE IT'S ACHIEVABLE CHALLENGING BUT ACHIEVABLE RECRUIT BASICALLY AS WE GO FORWARD. >> THE FACT YOU HAVE 24 HOUR EVENING AVAILABILITY FOR SAMPLE COLLECTION IS HELPFUL. >> THAT WAS NOT EASY TO SET UP, I WILL TELL YOU. >> ONE COMMENT, IN YOUR SUBSEQUENT SLIDES YOU TALK PHARMACOGENOMICS AND DRUG THERAPY AND PHARMACOGENOMICS. I A APPLAUD YOU FOR COLLECTING BIOSPECIMENS BECAUSE WE KNOW THAT ONE DOSE DOES NOT FIT ALL. AND GENOMICS IS ONLY ONE CO-VARIANT. BUT THERE'S GENOTYPE BUT THERE'S PHENOTYPE ENCOMPASSES MORE VARIABILITY IN TERMS OF EXPOSURE TO DRUGS. SO I LIKE THE FACT YOU HAVE PHARMACO GENOMICS IN HERE BUT ALSO ENCOURAGE YOU TO EXPAND YOUR THINKING TO PHENOTYPE AS WELL. >> OUR GOAL IS TO DEEPLY PHENOTYPE THIS COHORT AS MUCH AS WE POSSIBLY CAN. AND IT'S ANTICIPATING COST CURVE CONSIST OF DIFFERENT ASSAYS AN WHICH ARE WE GOING TO FUND, CAN WE DO PUBLIC PRIVATE PARTNERSHIPS FOR ONES WE CAN'T AFFORD THAT OTHERS WILL DO. BUT IT WILL BE A DEEPLY PHENOTYPED AT EVERY SENSE OF THAT WORD COHORT AS WE CARRY THEM OUT. >> LAST QUESTION, DR. GREGORY. (OFF MIC) >> GREAT SEGUE WHAT YOU JUST SAID. IN YOUR ULTIMATE VISION CAN JANE DOE Ph.D. WRITE A PROPOSAL AND BE ALLOWED TO DO HER OWN PROJECT BASED ON GETTING THE SPECIMENS AND EVERYTHING -- >> YES. >> FROM YOU GUYS? OR IF YOU'RE NOT ONE OF THE MAIN COHORTS -- >> THEY'RE ALL MAD BECAUSE THEY DON'T GET SPECIAL PRIVILEGES, THEY DON'T GET THE DATA EARLIER, THEY KEEP TELLING US WHY THEY SHOULD BUT NO, YOU HAVE A HUGE ADVANTAGE BECAUSE YOU UNDERSTAND HOW EVERYTHING IS SET UP. IT'S IMPORTANT FOR EVERYBODY TO UNDERSTAND, WE DON'T HAVE THE MONEY TO FUND THE RESEARCH WHICH IS WHY PARTNERSHIPS WITH FOUNDATIONS AND WITH NIH ALL PARTS OF NIH ARE SO IMPORTANT. WE HAVE THE MONEY DEPENDING WHAT CONGRESS DECIDES TO FUND PILOTS. THE DATA ACCESS, THERE WILL BE THREE TEASER, DATA ACCESS COMMITTEE IS JUST FINISHING. FOR THE DATA ITSELF IT WILL BE THREE TEASER, FIRST TIER OPEN TO ANYBODY THAT COMES TO THE WEBSITE WITH NO LOG IN AND SECOND TIER RISKIER DATA FOR REIDENTIFICATION THAT REQUIRES LOG IN AND TAKE ETHICS AND COMMITMENT PLEDGE. AND THE THIRD WILL BE MUCH MORE AFFILIATION WITH AN INSTITUTION AND MAKING SURE THAT YOUR COMMITTING AND UNDERSTANDING ALL THE RULES AROUND REIDENTIFICATION. BUT THE SAME THING WILL HAPPEN WITH ACCESS TO THE BIOSAMPLES THEMSELVES, AND THERE'S A WHOLE ACCESS AND CONTROLS PROCESS AND EVALUATION PROCESS WE HAVE TO SET UP FOR PEOPLE THAT WANT ACCESS THE COHORT ITSELF AS A WHOLE OR SMALL. THOSE ARE NOT READY. WE'RE LIKE BABY STEPS, GET IT OUT, START COLLECTING DATA BUT IT'S COMING. WE ALREADY SORT OF KNOW WHAT THE FIRST RESEARCHER TOOLS WILL BE AS WE CARRY FORWARD. DAYTIME WISE LAST QUESTION PEOPLE ASK ME, DEPENDING -- WE'RE DOING -- ONE THING I CAN BRING IS ITERATIVE USER CENTERED PRODUCT DEVELOPMENT AND DESIGN, AS LONG AS TESTING GOES WELL IN TERMS OF USER TESTING, SECURITY TESTING GOES WELL AND WE GET IRB TO I A PROVE THIS FINAL PIECE, WE ANTICIPATE LAUNCHING ALPHA AND BETA PHASE -- ALPHA MEANS EACH SITE STARTS WITH FRIENDLIES THE FIRST COUPLE OF WEEKS AND MOVES TO A BETA PHASE THEY'RE RACHETTING UP FROM A COUPLE OF SAMPLES PER WEEK -- COUPLE OF PARTICIPANTS PER WEEK TO MUCH HIGHER NUMBERS OVER A PERIOD OF TIME. SO THINK IF ALL GOES WELL, LAUNCH ALPHA AND BETA PHASE AND BETA PHASE WILL LAST 25 TO 30,000 PEOPLE, WE WILL STOP AND SAY ALL OUR SYSTEMS ARE READY FOR US TO OPEN UP NATIONALLY. HEAPFULLY THAT WILL HAPPEN -- HOPEFULLY THAT WILL HAPPEN IN SEPTEMBER OCTOBER, BUT IF IT'S DELAYED IT'S DELAYED BECAUSE WE'RE DOING IT CAREFULLY AND ITERATIVELY AS WE GO. GREAT TO BE HERE. I LOVE WHAT YOU DO. >> THANK YOU. [APPLAUSE] >> WE'RE GOING TO BREAK UNTIL 10:45. THANK YOU FOR GETTING US BACK ON TIME. APPRECIATE IT. WE'LL SEE YOU BACK AT 10:45. WE'LL RECONVENE, I WILL TURN THE PODIUM OVER TO MS. PARIS WATSON OF ORWH SO INTROTUESDAY THE NEXT SPEAKER. >> GOOD MORNING. IT IS MY HONOR TO WELCOME AND INTRODUCE DR. RICHARD NAKAMURA. DR. NAKAMURA SERVES AS DIRECTOR OF NIH'S CENTER FOR SCIENTIFIC REVIEW. AND HAS BEEN SERVING SINCE 2011 IN THAT POSITION. HE LEADS CSR'S 450 SCIENTISTS AND ADMINISTRATIVE STAFF OVERSEEING THEIR EFFORTS TO MANAGE 80,000 INCOMING NIH GRANT APPLICATIONS PER YEAR. WITHOUT FURTHER ADIEU, PLEASE WELCOME DR. NAKAMURA. [APPLAUSE] >> AS DR. NAKAMURA COMES TO THE PODIUM I WANT TO ACKNOWLEDGE TO MY LEFT DR. JAMES ANDERSON, DIRECTOR OF DPKPSI JOINED AS WELL. >> GOOD MORNING, EVERYONE, THANKS FOR BEING HERE. >> HI, I'M ALMOST SORRY TO INTERRUPT WHAT IS OFTEN THE MOST EXCITING PORTION OF THESE MEETINGS AND THAT IS INTERACTING WITH EACH OTHER AND ESSENTIALLY FINDING OUT WHAT HAPPENED SINCE THE LAST MEETING. I WANTED TO TELL YOU ABOUT SOMETHING THAT I REGARD AS EXCITING THOUGH PEER REVIEW IS OFTEN SEEN AS KIND OF AREA. I DON'T KNOW HOW THIS SLIDE GOT IN THERE. I DIDN'T MEAN TO DO ANY TALK ABOUT VERTEBRATE ANIMAL RESEARCH. THAT IS AN IMPORTANT ISSUE LATER. WHAT I WANTED TO DO IS EMPHASIZE NIH'S MISSION WHICH WE SUPPORT, MISSION TO SEEK FUNDAMENTAL KNOWLEDGE OF NATURE AND BEHAVIOR OF LIVING SYSTEMS AND APPLICATION OF THAT KNOWLEDGE TO ENHANCE HEALTH LENGTH AND LIFE AND REDUCE ILLNESS AND DISABILITY. I WANT TO EMPHASIZE THAT FRANCIS COLLINS AND LEADERSHIP OF NIH POINTED TO THIS MISSION AS HAVING TWO PARTS. A FUNDAMENTAL COMPONENT OF BASIC SCIENCE WHERE WE'RE TRYING TO ADVANCE OUR KNOWLEDGE OF BIOLOGY AND BEHAVIORAL SCIENCES TO HAVE A BASE FROM WHICH TO APPLY TO DO THE PUBLIC HEALTH RELEVANT SECTION OF OUR MISSION. NIH ACHIEVES ITS MISSION THROUGH LARGELY THROUGH AWARDING RESEARCH GRANTS BASED UPON PEER REVIEW OF APPLICATIONS FROM EXTRAMURAL SCIENTISTS. VIRTUALLY ALL COUNCILS REPRESENTS A SUBSTANTIAL PORTION INTEREST IN THAT INTRAMURAL SCIENCE. THE QUESTION THAT COMES UP, ARE DR. GENDER DISPARITIES IN OUR GRANT AWARD SYSTEM. SO I THOUGHT I WOULD REVIEW FIRST I THOUGHT I WOULD REVIEW WITH YOU WHAT THAT WAS -- THOSE NUMBERS LOOK LIKE. SO THESE ARE RESEARCH GRANT AWARDS BY GENDER ON THE LEFT HERE ARE THE NUMBER OF AWARDS, ON THE RIGHT ARE PERCENTAGE GIVEN TO WOMEN. SO YOU CAN SEE THE NUMBER OF AWARDS CLIMBED RAPIDLY FROM THE LATE '90s TO ABOUT 2004. DURING THE DOUBLING OF THE NIH BUDGET. THEN SINCE THEN IT'S BEEN DECLINING SLOWLY OVER THE NEXT 14 YEARS, THIS YEAR WE'RE ANTICIPATING THE -- I MEAN IN, IN 2016 AWARDS WENT UP A BIT BECAUSE WE GOT OUR FIRST GREATER THAN INFLATIONARY INCREASE. THIS LINE SHOWS THE PROPORTION OF GRANTS GOING TO WOMEN WHICH IS A LITTLE OVER 30% NOW AND THIS IS THE AWARDS THAT ARE GOING TO WOMEN. SO THE RED LINE IS THE PROPORTION AND THE BLUE LINE ARE THE ABSOLUTE NUMBER OF AWARDS. CLEARLY THERE'S A SIGNIFICANT GAP BETWEEN MEN AND WOMEN IN THE NUMBER OF AWARDS AND IN THE PROPORTION OF AWARDS THAT ARE GOING TO WOMEN. NOW THE SITUATION IN TERMS OF THE SUCCESS RATES OF MEN AND WOMEN IS A LITTLE BIT DIFFERENT. IN LIGHT GREEN ARE MEN AND BLUE ARE WOMEN. YOU CAN SEE THAT THOUGH SUCCESS RATE DROPPED SIGNIFICANTLY OVER THE LAST TWO DECADES, THE DIFFERENCE BETWEEN MEN AND WOMEN IS RELATIVELY SMALL. RIGHT NOW THE SUCCESS RATES FOR THE TWO GROUPS ARE HOVERING AROUND 20% WITH WOMEN SLIGHTLY BELOW MEN. IT IS INFORMATIVE TO SPLIT UP BETWEEN TYPE 1 AND 2 GRANTS, TYPE ONES ARE INITIAL FUNDING OF A NEW PROJECT IDEA. TYPE 2 ARE COMPETING CONTINUATIONS FOR WHEN YOU'RE TRYING TO CONTINUE RESEARCH ON AN IDEA. USUALLY AFTER FOUR OR FIVE YEARS. YOU CAN SEE FOR TYPE 1s THE SUCCESS RATE IS PRETTY LOW BUT MEN AND WOMEN ARE VIRTUALLY FOR THE LAST TEN YEARS HAVE BEEN VIRTUALLY THE SAME IN OVERALL SUCCESS RATE. TYPE 2s WHICH ARE SMALL PROPORTION OF THE OVERALL AWARDS BUT THIS IS MORE SENIOR SCIENTIST TEND TO, STILL THERE IS A GAP. THIS GAP ACCOUNTS FOR THE SMALL GAP THAT EXISTS BETWEEN MEN AND WOMEN. WE THINK THAT THIS IS A REMAINING AREA OF INTEREST TO WHY THERE IS A DIFFERENCE IN TYPE 2 SUCCESS RATES BETWEEN MEN AND WOMEN. BUT IT IS OVERALL CLEAR THE LARGEST GAP IS DUE TO DIFFERENCES IN APPLICATION NUMBERS COMING FROM MEN AND WOMEN. SO PART OF A GAP CLOSURE THAT HAS TO GO ON NOW IS TO ENSURE THAT WOMEN ARE IN SITUATIONS WHERE THEY CAN APPLY IN EQUAL NUMBERS TO MEN. SO FAR THAT ISN'T HAPPENING. ANOTHER PART OF THIS IS WHAT IS THE DIFFERENCE BETWEEN PROPORTION OF MEN AND WOMEN ON OUR REVIEW PANELS. SO ONE CAN UNDERSTAND THERE MAYBE DIFFERENCES IN NUMBER OF MEN AND WOMEN AND THAT MAY AFFECT TO SOME EXTENT DIFFERENCES IN SCORING. AND SO THERE HAVE BEEN A VERY SLOW CHANGE OVER YEARS, THIS IS THE LAST SEVEN YEARS SHOWING, THERE IS A SMALL GROUP WHOM WE DON'T KNOW THE SEX OR GENDER. SO WOMEN ARE A LITTLE OVER 30% IN TOTAL, IF YOU GO TO ANY GIVEN MEETING, COUNT THE NUMBER OF MEN AND WOMEN BOTH REGULAR MEMBERS AND AD HOCS, THERE'S A LITTLE OVER 30% WOMEN AND THEN THIS IS THE PROPORTION OF MEN WHICH IS ABOUT 62, 3 PERCENT. IN TERMS OF REGULAR MEMBERSHIP, THIS IS A LITTLE EASIER FOR US TO KEEP CLOSE TABS ON, THERE'S A GREATER CHANGE IN THE PROPORTION OF WOMEN SO REGULAR MEMBERS OF COMMITTEES WE HAVE GONE SINCE 2010 FROM A LITTLE OVER 34% TO A LITTLE OVER 39% SO THAT HAS BEEN DEFINITELY TRENDING UP ABOUT A FIVE PERCENT OVERALL INCREASE. WE ARE AIM UP TO 40% FOR FOR THE TIME BEING. SO THAT COMPARES TO THE OVERALL AWARD RATE OF ABOUT 30%. BY THE WAY IN TERMS OF CHAIRS GETTING CLOSE TO 40% IN TERMS OF CHAIRS OF OUR COMMITTEE. I THINK A CERTAIN AMOUNT OF NIH ENCOURAGEMENT HAS HELPED MAKING SURE WHEN WOMEN ARE CONSIDERED AND WHEN WOMEN ARE CONSIDERED THEIR APPOINTMENTS SEEM TO OCCUR REGULARLY. ONE OF THE ISSUES THAT HAS BEEN OF INTEREST BOTH TO WOMEN AND MINORITIES POPULATIONS HAS BEEN THE POSSIBILITY OF IMPLICIT BIAS MAYBE AFFECTING THINGS. FOR WOMEN IT LOOKS LIKE BIAS IS NOT AFFECTING OVERALL SUCCESS RATE OF WOMEN GIVEN THE NUMBER OF APPLICATIONS THEY SUBMIT. THERE MAYBE SOME EFFECT OF BIAS ON THE DECISION TO APPLY. BUT I JUST LIKE WE HAVE BEEN LOOKING AT THIS ISSUE AND THAT WE HAVE ALSO SEEN THAT EVERY MEASURE OF IMPLICIT BIAS PARTICULARLY AS IT RELATES TO SEX SHOWS THAT THERE IS A BIAS THAT AFFECTS WOMEN AND USUALLY THE ADJECTIVES ASSOCIATED WITH WOMEN COMPARED TO MEN ARE SEEN SLIGHTLY MORE NEGATIVE FROM A SCIENTIFIC CONTEXT FOR WOMEN. THAT DOESN'T SEEM TO BE AFFECTING THE AWARD RATE. AS MUCH AS IT DOES FOR MINORITY POPULATIONS. WITH MONICA BASCO WHO WAS WORKING AT CSR, WE HAD A GROUP THAT WAS LOOKING AT THE ISSUE OF IMPLICIT BIAS. CAME TO A FEW CONCLUSIONS, ONE IS THAT THERE ARE SOME METHODS RIGHT NOW WHICH SEEM TO INFLUENCE IMPLICIT BIAS, THAT IS YOU COULD REDUCE DIFFERENCE IN CONNECTIONS OF WOMEN TO SAY MORE NEGATIVE ADJECTIVES OR MINORITY POPULATIONS TO MORE NEGATIVE ADJECTIVES. BUT WEN WE ALL TAKE THOSE TESTS VIRTUALLY EVERYONE SHOWS SOME IMPLICIT BIAS, IT'S NOT JUST MEMBER SHOWING IN, IT'S WOMEN AS WELL, FOR MINORITY POPULATIONS, IT'S NOT JUST MAJORITY POPULATIONS THAT ARE SHOWING THIS, TO SOME EXTENT MINORITY POPULATIONS THAT ARE SHOWING THE SAME KINDS OF TRENDS. RESEARCH IN THESE AREAS SHOW THAT YOU CAN AFFECT IN THE SHORT TERM THESE CONNECTIONS. BUT IT SEEMS THAT GIVEN THE COMMON IDEAS IN OUR SOCIETY AFFECTING THESE LONG TERM IS VERY DIFFICULT. SOMETHING WHICH WE HAVE BEEN ENCOURAGED TO THINK ABOUT, AND I WOULD LIKE TO HEAR MORE FROM THIS GROUP ABOUT THIS, IS THAT RATHER THAN TRYING TO CHANGE THAT CONNECTIVITY, THE UNCONSCIOUS CONNECTIONS THAT WE MAKE, WE'RE BETTER AT CHANGING THE CONSCIOUS CONNECTIONS THAT WE MAKE. WE'RE BETTER AT CHANGING THE CONSCIOUS DECISION OF UNDERSTANDING WE HAVE PREJUDICES OR BIASES BUT WE CAN COUNTER THEM CONSCIOUSLY. YOU MAY NOT BE ABLE TO DO AFFECT IT THAT MUCH SUBCONSCIOUSLY BUT IN THE LONG RUN IF WE CAN CHANGE WHAT HAPPENS ABOVEBOARD AND HAPPENS AT THE CONSCIOUS LEVEL, SOON THE SUBCONSCIOUS BEHAVIORS AND SUBCONSCIOUS IDEAS WILL GET ELIMINATED BECAUSE YOU WILL GET COUNTER EXAMPLES ALL THE TIME. SO I THINK OUR BELIEF THAT MEN WERE BETTER AT MUSICAL INSTRUMENTS, AND THEIR POSITION IN OUR ORCHESTRAS WAS REASONABLE, HAS BEEN HEAVILY UNDERMINED BY BLIND TESTING OF INDIVIDUALS. ONCE WE DEVELOPED A SYSTEM FOR ELIMINATING THE BIAS EVEN IF THE BRAIN IS STILL OPERATING AT THAT LEVEL, UNCONSCIOUS LEVEL, IT LOOKS LIKE WE CAN CHANGE OUR BEHAVIOR. AND THEN CHANGING OUR BEHAVIOR WILL ULTIMATELY CHANGE WHAT WE BELIEVE TO BE TRUE ABOUT THE WORLD. SO WE HOPE TO CONTINUE THIS. SO WE'RE TRYING TO FIGURE OUT IN A NEW STUDY CSR IS WORKING ON, TO TRY AND SEE IF WE CAN ONE DETERMINE WHETHER OR NOT BIAS, IMPLICIT BIAS OR NOT HAS BEEN AFFECTING THE OUTCOMES OF PEER REVIEW AND AFFECTING THE OUTCOMES OF DECISIONS IN PEER REVIEW. THIS WAS BASED INITIALLY ON THE FINDING AROUND GINTHER ET AL AROUND THE TIME I JOINED CSR, THAT SHOWED THAT AFRICAN AMERICANS IN PARTICULAR BUT OTHER GROUPS AS WELL HAD AN AWARD RATE, SUCCESS RATE WHICH WAS DISTINCTLY DIFFERENT FROM OTHER SCIENTISTS, IN PARTICULAR WHITE APPLICANTS. IT WAS IN THE GINTHER PAPER THEY SAID IT WAS ABOUT 10% DIFFERENCE IN SUCCESS RATE FOR AFRICAN AMERICANS THAN WHITES BUT BECAUSE SUCCESS RATE IS SO RELATIVELY LOW, THE AFFECT OF THIS WAS ABOUT AFRICAN AMERICANS RECEIVING APPLICATIONS AT ABOUT 55%. RATE OF WHITE APPLICANTS. THIS IMMEDIATELY BECAME A VERY HIGH PRIORITY FOR NIH. AND FRANCIS COLLINS, DIRECTOR OF NIH, MADE THIS THE HIGHEST PRIORITY OF HIS ADVISORY COMMITTEE TO THE DIRECTOR TO TRY AND UNDERSTAND WHAT WAS GOING ON HERE, WHAT NIH COULD DO TO TO BOTH UNDERSTAND AND TO CHANGE WHAT WAS HAPPENING. ONE OF THE SUGGESTIONS OF THE ADVISORY COMMITTEE TO THE DIRECTOR AMONG OTHER THINGS AIMED AT CENTER FOR SCIENTIFIC REVIEW WAS TO DO A STRONG STUDY OF BIAS AND THEY SUGGESTED AN ANONOMYZATION EXPERIMENT IN WHICH APPLICATIONS WERE ANONYMIZED WHERE THEY RACE OF THE APPLICANT WAS DEEPLY CONCEALED TO SEE WHETHER OR NOT THAT WOULD CHANGE THE OUTCOME OF APPLICATIONS. SO WE KNEW THAT RACIAL DISPARITIES AND GRANT FUNDING EXISTS WHILE IT WAS STARK FOR AFRICAN AMERICANS, IT WAS ALSO PRESENT FOR LATINOS FOR ASIANS AND THERE WAS A SMALL DIFFERENCE, GINTHER THAT INITIALLY POINTED OUT THAT THE DIFFERENCE AMONG WOMEN WAS STRONGEST FOR TYPE 2 APPLICATIONS. WE ALSO BY LOOKING AT PRELIMINARY SCORES WE LEARNED THAT AT LEAST WHILE THREE RVIEWERS EVALUATE APPLICATIONS THEIR AVERAGE PRELIMINARY OVERALL IMPACT SCORES ACCOUNT FULLY FOR THE VARIANTS IN FINAL SCORES. SO EVEN THOUGH THERE WAS SOME CHANGE AS A RESULT OF DISCUSSION THAT DIDN'T AFFECT THE OUTCOME OF MINORITY GROUPS. MAJOR HYPOTHESES OFFERED BY GINTHER ET AL PAPER WAS REVIEWER BIAS OR A DIFFERENCE IN THE OVERALL QUALITY OF APPLICATION SUBMISSIONS. AND PERHAPS IF WE COULD CONDUCT A GOOD STUDY OF ANONOMYZATION AS QUALITY CONTROL CHECK WE CAN SEE WHAT WAS GOING ON IN PEER REVIEW PROCESS. SO I'M GOING TO DESCRIBE TO YOU THE STUDY AND IT'S A DETERMINANT OF MASKING PERSONALLY IDENTIFIABLE INFORMATION FROM GRANT APPLICATIONS CHANGES THE DIFFERENCE IN FINAL SCORES. WE ARE LOOKING FOR -- TO SEE ABOUT CHANGE FOR BLACK AND WHITE APPLICANTS AS OUR PRIMARY AIM BUT BECAUSE WE KNOW THERE ARE VARIOUS DIFFERENCES THAT HAVE BEEN OBSERVED FOR MALE AND FEMALE APPLICANTS FOR ESTABLISH VRSUS EARLY STAGE INVESTIGATOR APPLICANTS, FOR APPLICANTS FOR MORE RESEARCH INTENSIVE VERSUS LESS INTENSIVE INSTITUTIONS WE'RE ALSO LOOKING TO SEE WHETHER OR NOT ANONOMYZATION AFFECTS THOSE GROUPS. WE'RE GOING TO BE USING 400 APPLICATIONS FROM AFRICAN AMERICAN SCIENTISTS, 400 FROM A MATCH SAMPLE OF WHITE SCIENTIST, MATCHED BY SCIENCE AREA SCORE GENDER DEGREE INSTITUTION. AND SENIORITY. TO FULLY REPLICATE THE DIFFERENCE THAT OCCURS NATURALLY IN PEER REVIEW PROCESS, WE WILL USE 400 WHITE RANDOMLY SELECTED. SO WE KNOW THIS RANDOMLY SELECTED GROUP VERSUS AFRICAN AMERICAN GROUP FULLY RECAPITULATES THE SCORING AND PROPORTION AWARD DIFFERENCE BETWEEN THE TWO GROUPS AND THE WHITES ARE MATCHED TO SEE IF THEIR SCORES WILL CHANGE. SO IF THERE IS A -- IF THERE'S BIAS GOING ON WE ANTICIPATE FOR THE MATCHED AFRICAN AMERICAN WHITE SAMPLES, WHITE SCIENTIST SCORES WORSEN OR AFRICAN AMERICAN SAMPLES SCORES WOULD IMPROVE TO THE EXTENT BIAS IS INFLUENCING THEIR SCORES. FOR THE OTHER GROUP, THE AFRICAN AMERICAN VERSUS RANDOMLY SELECTED BITES WE WOULD EXPECT THAT THE GAP BETWEEN THEM WOULD NARROW TO THE EXTENT THERE IS BIAS. RIGHT NOW WE HAVE LET A CONTRACT TO AN ORGANIZATION, WE WILL BE USING REVIEWERS THAT WE ALWAYS USE FOR REGULAR PEER REVIEW. THE REVIEWERS WILL BE SELECTED BY SROs TO HAVE EXPERTISE RELEVANT TO GRANT APPLICATIONS. BUT WE'RE HAVING AN OUTSIDE ORGANIZATION ACTUAL HI RUN THE STUDY BECAUSE CONCERN EXPRESSED TO US FROM NUMBER OF SCIENTISTS THAT NIH HAS AN INTEREST IN SHOWING THERE'S NO BIAS AND THAT THEY WOULD PREFER SOMEONE ELSE LOOK AT THIS AS WELL AS OUR STAFF. SO WE ARE HAVING A MINORITY OWNED OUTSIDE GROUP THAT'S DONE NICE WORK FOR NIH IN THE PAST RUN THE STUDY. WE'RE GOING TO BE -- WE'RE NOT GOING TO BE HAVING THE DISCUSSION PHASE BECAUSE WE KNOW THE FULL VARIANTS OCCURS WITHIN THE IN THE PRELIMINARY SCORE FACE SO WE'RE ASKING ARE VIEWERS TO GIVE PRELIMINARY SCORES FOR COMPARISON. WE'RE GOING TO DEBRIEF EACH APPLICATION TO ASK WHETHER THEY CAN IDENTIFY THE INVESTIGATOR LAB OR INSTITUTION. THESE ARE EXPERTS IN VARIOUS AREAS AND COULD BE EVEN ANONYMIZED. THEY WILL KNOW ENOUGH ABOUT THE SITUATION TO GUESS WHO THIS IS. CAN THEY IDENTIFY RACE GENDER SENIORITY OF PI AND CAN THEY RATE GRANTSMANSHIP OF THE APPLICATION? WE ARE LOOKING FORWARD TO THE RESULTS WE'RE EXPECTING IN ABOUT 18 MONTHS, WE WILL START GETTING THOSE RESULTS. THIS IS -- 7200 REVIEWS WILL BE INVOLVED, THIS WILL BE A VERY LABOR INTENSIVE STUDY. WHAT ABOUT THE REVIEW OF RIGOR AND REPRODUCIBILITY PARTICULARLY SEX AS A BIOLOGICAL VARIABLE? I KNOW I PEOPLE -- WE HAVE TO KEEP MOVING HERE. SO THE WHOLE RIGOR AND REPRODUCIBILITY INTEREST IN SCIENCE, THE BROADER GROUP OF ISSUES, WITHIN WHICH SEX IS A BIOLOGICAL VARIABLE IS EMBEDDED HAS BEEN A CHALLENGE. FOR A NUMBER OF YEARS NOW WE HAVE BEEN HEARING CONCERNS THAT NIH SCIENCE IS NOT REPLICABLE OR APPROPRIATELY REPLICABLE. SO THERE'S BEEN A NUMBER OF PAPERS IN WHICH ATTEMPTS TO REPLICATE NIH SCIENCE HAS BEEN GOING ON. WE HAVE BEEN HEARING FROM INDUSTRY THEY FOLLOW NO LONGER TRUST NIH RESULTS. BECAUSE THEY CANNOT REPLICATE THOSE RESULTS AND SO THEY HAVE TO REPEAT EVERYTHING THAT IS OF INTEREST TO THEM. THIS IS ESPECIALLY TRUE IN PRE-CLINICAL RESEARCH. THIS IS A SLIDE TAKEN FROM LARRY TABAK WHERE HE WAS JUST SORT OF CAPTURING MANY OF THE PRESS AND JOURNAL-RELATED TITLES. ABOUT THE PROBLEM OF REPRODUCIBILITY IN STUDIES WHAT INDUSTRY WAS SAYING IS THAT THE VAST MAJORITY OF STUDIES THEY ATTEMPTED TO REPLICATE THAT WERE IMPORTANT FOR THEM, FAILING TO REPLICATE WHEN INSTITUTE THEMSELVES DID SYSTEMATIC STUDIES SO THE NEUROLOGY INSTITUTE TRIED TO DO STUDIES, LESS THAN HALF COULD BE REPLICATED. THE CANCER INSTITUTE IS RECENTLY FUNDED A SET OF STUDIES FOR THE CENTER OF OPEN SCIENCE TO REPLICATE 50 APPLICATIONS. THEY HAVEN'T BEEN ABLE TO GET THAT MANY STUDIES DONE, THE ONES THEY HAVE DONE SO FAR LESS THAN HALF SEEM THE REPLICATE. WE KNOW THAT THIS MONTH RICHARD HARRIS WILL BE PUTTING OUT A SIGNIFICANT PUBLICATION BASICALLY SAYING THAT OUR STUDIES ARE NOT REPLICABLE. THIS IS NOT GOOD FOR NIH AT A TIME WHEN SOME INDIVIDALS ARE CALLING FOR A CUT IN THE NIH BUDGET. SO FROM ALL OF OUR PERSPECTIVES, THERE IS A PROBLEM. AND NIH HAS BEEN I THINK VIGOROUS IN RECOGNIZING THAT THERE IS A PROBLEM, TRANSPARENT ABOUT RECOGNIZING THAT THERE WAS A PROBLEM. AND WORKING AT SOLVING THE PROBLEM TO RESTORE HIGH QUALITY SCIENCE AND CREDIBILITY BUT ALSO TO UNDERSTAND WHY THERE'S AN OVERALL PROBLEM. I THINK APPROPRIATELY NIH SAW THAT A MAJOR CONTRIBUTOR TO THE OVERALL PROBLEM WAS IN THE PUBLICATIONS THAT WERE EMERGING. AND IN A SENSE ONE OF THE MAJOR SOURCES WAS IN OUR VERY HIGHEST REPUTATION JOURNALS. JOURNALS LIKE SCIENCE, NATURE, CELL, THAT HAD THE HIGHEST REPUTATION, HIGHEST JOURNAL IMPACT FACTORS YET OFTEN WERE HAVING TROUBLE BECAUSE THE METHODOLOGY BEHIND THE REALLY INTERESTING STORIES THAT THEY GENERATED WERE -- WORSE THAN SUSPECT, COULDN'T BE REPLICATED. PART OF IT LOOKED LIKE IT WAS A PROBLEM WITH JOURNAL EDITORS COMPETING WITH EACH OTHER FOR THE MOST EXCITING STORY AS A OPPOSED TO THE STRONGEST AND MOST RIGOROUS SCIENCE. BECAUSE THEY ARE REWARDED BY INCREASING THE JOURNAL IMPACT FACTOR AND NOT NECESSARILY BY SHOWING 20 YEARS DOWN THE ROAD THEIR SCIENCE WAS THE BEST OUT THERE. SO NIH IN ORDER TO SUPPORT HIGHEST QUALITY SCIENCE AND PUBLIC ACCOUNTABILITY AND SOCIAL RESPONSIBILITY LAUNCHED A RIGOR AND REPRODUCIBILITY INITIATIVE TO CLARIFY EXPECTATIONS AND HIGHLIGHT ATTENTION TO AREAS WHICH IN THE END CENTER FOR SCIENTIFIC REVIEW AND OUR OTHER REVIEW GROUPS WERE CHARGED WITH ENFORCING. SO AMONG OTHERS THINGS THEY WANTED TO MAKE SURE PROJECTS THAT WERE PROPOSED HAD A STRONG SCIENTIFIC PREMISE. PREMISE WAS PROBABILITY A -- NOT A GREAT WORD TO CHOOSE BECAUSE THERE ARE A LOT OF DIFFERENT IDEAS BEHIND WHAT PREMISE MIGHT MEAN. SO INITIALLY WE HAD REVIEWERS THAT THOUGHT THIS WAS THE HYPOTHESIS. BUT WHAT NIH HAS MEANT IS THAT THE SCIENTIFIC FOUNDATIONS, THE BASIS FOR PROPOSING THE PROJECT, PRELIMINARY DATA, THE FOUNDATIONAL PAPERS THAT LED TO THE IDEA THAT WAS IN THE PROJEC PROPOSAL WERE STRONG IN AND OF THEMSELVES. HERE ARE THE THOUGHT WAS A PROJECT PROPOSAL BUILT UPON SAM WOULD NOT BE REPLICABLE. THERE WAS ALSO AN EMPHASIS ON SCIENTIFIC RIGOR. THIS WAS HARDER FOR PEER REVIEW IN THAT WE'RE TRYING TO ASK FOR SHORT PROPOSALS, NOT PROTOCOLS, BUT THE IDEAL HERE WAS TO ENSURE THAT THE METHODOLOGY OF EACH OF THE STUDIES THAT LED TO PAPERS WERE DONE ON A RIGOROUS BASIS WITH STRONG METHODOLOGY. TO ENSURE RELEVANT BIOLOGICAL VARIABLES WERE THOROUGHLY CONSIDERED. EARLY ON PARTICULARLY JANINE WITH FRANCIS AND THE OFFICE OF WOMEN'S HEALTH RESEARCH, MADE SURE SEX WAS INCLUDED AS AN IMPORTANT BIOLOGICAL VARIABLE. I THINK AS YOU HAVE ALL HEARD JANINE SAY MANY TIMES, THAT WE OFTEN GOT IT WRONG BY FAILING TO CONSIDER SEX OR IN MANY CASES IN WHICH THERE WERE MIX SEX ANIMALS IT WAS TREATED AS NON-RELEVANT VARIABLE SO PEOPLE DID NOT ACTUALLY CATALOG OR CHART THE INFORMATION BASED ON SEX SO THE INFORMATION WAS LOST. ENOUGH HAS BEEN LEARNED ABOUT THE IMPORTANCE OF SEX AS A BIOLOGICAL VARIABLE AND THAT IT DOES DIFFER IN MANY DIFFERENT DOMAINS BEHAVIOR DOES DIFFER IN MANY DIFFERENT DOMAINS TO EMPHASIZE THE FAULTY OF THAT IDEA. SO WE HAVE BEEN EMPHASIZING TRYING TO MAKE SURE THAT SEX AND REFERENCE TO BOTH SEXES IS REGULARLY AND VIRTUALLY ALWAYS INCLUDED IN OUR STUDIES. FINALLY THERE WAS A PROBLEM WITH AUTHENTICATION OF KEY BIOLOGICAL CHEMICAL RESOURCES THAT THERE WAS MISIDENTIFICATION OF ANIMALS OR ANTIBODIES AND THEIR AFFECTS THAT THERE WERE CONTAMINATIONS OF CELL LINES AND THESE TWO LED TO PROBLEMS. I WON'T GO OVER THIS EXCEPT TO SHOW THAT ONE OUR RESEARCHERS, DR. SHY SILVERBERG, ONE OF THE EARLY INDIVIDUALS WHO POINTED TO A SERIOUS PROBLEM DID A STUDY OF MANY PUBLICATIONS AND SHOWED VERY FEW RANDOMIZED CONDITIONS HAD BLINDED ASSESSMENT OF OUTCOMES, AND VIRTUALLY NONE DID SAMPLE SIZE CALCULATIONS OR POWER CALCULATIONS. ACROSS STROKE STUDYINGS STROKE PATHOPHYSIOLOGY STUDIES, PARKINSON'S DISEASE AND MULTIPLE SCLEROSIS. THIS DID HAVE AN EFFECT ON OUTCOMES. ONE OF THE PROBLEMS WITH THE LONG TERM LOW FUNDING FUNDING OF NIH HAS BEEN THE PUSH FOR -- FROM SCIENTIST TO TRY AND GET AWAY WITH SMALLER UNDERPOWERED STUDIES. BECAUSE THEY FELT THEY WERE EXPECTED TO PRODUCE AS MANY PUBLICATIONS. AT THE SAME TIME GETTING LESS AND LESS MONEY OR HAVING COSTS GO UM SIGNIFICANTLY. -- UP SIGNIFICANTLY. THIS LED TO SMALLER UNDERPOWERED STUDIES, MORE FALSE NEGATIVES, MORE FALSE POSITIVES. REDUCE POSITIVE PREDICTIVE VALUE AND CERTAINLY MUCH LESS POWER. THERE WAS ALSO A TENDENCY TO SELECTIVELY REPORT DATA SUBJECTS AND EXPERIMENTS, LEAVE OUT INFORMATION IN STUDIES ESPECIALLY WHEN THEY WERE INCONVENIENT FACTS FOR STUDIES. NIH HAS BEEN DOING A LOT TO RAISE COMMUNITY AWARENESS, THERE HAVE BEEN WORKSHOPS WITH PHARMA AND JOURNAL EDITORS IN ORDER TO COME TO NEW CONCLUSIONS. AND I THINK THERE'S BEEN A GENERAL APPRECIATION THAT WE HAD A PROBLEM. THERE IS A ROLE FOR INDIVIDUAL SCIENTISTS AS WELL, WE NEED YOU TO STIMULATE DISCUSSION AMONG SOCIETIES AND ORGANIZES. INCREASE TRANSPARENCY ABOUT WHAT'S GOING ON IN OUR STUDIES, PROMOTE TRAINING AND EXPERIMENTAL DESIGN, ENCOURAGE DATA AND MATERIAL SHARING AND MAKE SURE YOU PUBLISH REPUTATIONS AND NEGATIVE RESULTS. ONE THING THAT NIH AND I THINK JIM ANDERSON IS PLAYING A ROLE THIS AS WELL HAS BEEN TO HELP MAKE SURE PUBLICATION VENUES LIKE PREPRINTS, MAKE MAKING EASIER TO AT LEAST GET OUT INFORMATION ABOUT NEGATIVE RESULTS AND REPUTATIONS. TO MAKE THEM AVAILABLE. WHAT IS PEER REVIEW DOING? I'M GOING TO SAY THIS QUICKLY, I THINK MANY OF YOU KNOW A THANK YOU ALL FOR SERVING ON PEER REVIEW, IT IS EXTREMELY IMPORTANT ESPECIALLY THESE DAYS. BUT WE SET OUT THESE CHARTS WHAT YOU HAVE TO EVALUATE, WHERE YOU PUT THAT EVALUATION, WHETHER OR NOT IT'S SUPPOSED TO AFFECT THE OVERALL SCORE. AND TO ENSURE THE UNDERLYING FOUNDATION OF PROJECTS CONCEPTS PREVIOUS WORK AND DATA ARE SOUND, WE WANT TO MAKE SURE PREMISE IS NOT CONFUSED WITH HYPOTHESIS OR SIGNIFICANCE. DICTIONARY DEFINITION HELPS ADD TO CONFUSION BY EQUATING PREMISE AND HYPOTHESIS AS ONE OF THE SYNONYMS. AND THAT WASN'T THE INTENTION, AND WE'RE TRYING TO GET THAT CORRECTED. WE WANT TO MAKE SURE THAT WHEN YOU DO THIS, YOU ENSURE THIS IS ABOUT SCIENTIFIC FOUNDATION OR PRELIMINARY DATA THAT GOES WITH IT. I'M GOING TO MOVE ON BECAUSE I HAVE GONE OVER THESE ISSUES. AND WANT TO JUST STATE SEX IS A BIOLOGICAL VARIABLE HAS ACTUALLY BEEN ONE OF THE AREAS THAT CAUSED THE MOST CONSTERNATION AMONG OUR REVIEWERS. INITIALLY BECAUSE THERE WERE MANY INDIVIDUAL SCIENTISTS WHO FELT LIKE ALWAYS JUST BEEN USING MLE RATS OR MALE MICE WHY DO I HAVE TO CHANGE. I THINK IN GENERAL AS THERE'S GROWING APPRECIATION FOR THE WHY, YOUR RESULTS DON'T STAND UP WHEN YOU INCLUDE MORE COMPLEX POPULATION, WHEN YOU INCLUDE FEMALE RATS. THERE WERE A FEW INDIVIDUAL WHOSE SAID THEY ONLY WANTED TO STUDY FEMALES AND AGAIN, THE ANSWER IS THAT YOU HAVE TO STUDY BOTH UNLESS YOU'RE LOOKING AT A CONDITION THAT ONLY AFFECTS SINGLE SEX. I THINK EVERYBODY IS GETTING IT. THE LAST PART THAT'S CAUSING CONSTERNATION IS THAT I WILL HAVE TO INCREASE MY BUDGET IN ORDER TO ACCOMMODATE THIS NEW GUIDANCE, NIH IS READY TO PAY EXTRA -- PEGGY MCCARTHY HAS DONE A NICE JOB POINTING OUT IF YOU DON'T KNOW WHAT THE DIFFERENCE IS BETWEEN SEXES ALREADY, YOU DON'T NEED TO HAVE IT FULLY POWERED FOR MINUSCULE SEX DIFFERENCE. ALL WE WANT -- ALL WE NEED TO KNOW IS THERE A SIGNIFICANT DIFFERENCE, IS THERE A TREND TOWARDS A DIFFERENCE THAT SHOULD BE EXPLORED IN SUBSEQUENT STUDIES? I WOULD SAY NOW WE HAVE JUST FINISHED OUR THIRD ROUND, WHAT I'M HEARING A LOT MORE IS PEOPLE ARE GETTING IT, PEOPLE REALLY ARE TAKING IT OUT ON SCORE. IF THERE AREN'T BOTH SEXES INCLUDED THAT INDIVIDUAL REVIEWERS ARE MORE SKEPTICAL WHEN THERE'S AN EXCUSE MADE FOR NOT INCLUDING BOTH SEXES. SO I BELIEVE THIS ISSUE IS GOING WELL. IT WOULD BE NICE TO HAVE OVERALL A STRONGER BUDGET FOR NIH. WE ALSO RECOGNIZE THAT DIFFERENT RESEARCH FIELDS HAVE DIFFERENT BEST PRACTICES FOR AND REACH DIFFERENT CONCLUSIONS ABOUT SCIENTIFIC PREMISE AND RIGOR. SO WE ASK OUR REVIEWERS TO USE THE WORDS AND ASSESS BASED ON BEST PRACTICES IN THE FIELD. SOMETIMES A GROUP -- A FIELD NEEDS TO CHANGE ITS BEST PRACTICES BUT OFTEN THE BEST PRACTICES THAT ARE AVAILABLE ARE IN FACT PRETTY GOOD. IT'S JUST THAT ALL THE SCIENTISTS IN THE FIELD NEED TO ADOPT THEM. TO REMIND YOU PAGE LIMITS HAVE NOT CHANGED. THAT COSTS OF LARGER SUBJECT POPULATIONS SHOULD BE JUSTIFIED BUT AT THE SAME TIME NIH HAS TO BE PREPARED TO PAY IT QUESTION ABOUT EXPLORATORY STUDIES HAS COME UP. WE WANT TO REASSURE EVERYONE NIH APPRECIATES AND WANTS EXPLORATORY STUDIES. THAT DOESN'T MEAN THAT STRONG RIGOROUS SCIENCE CANNOT BE DONE WITH THOSE STUDIES. BUT AS CLEAR DIFFERENCE NEED TO BE MADE BETWEEN PRE-CLINICAL STUDIES AND EXPLORATORY STUDIES, WHAT SOMETIMES HAPPENED IN THE PAST IS THAT A SCIENTIST THAT STARTED OUT WITH AN EXPLORATORY STUDY SUDDENLY -- AND SIMPLY STOP NOT THEY STOPPED THE STUDY WHEN THEY HAD ENOUGH TO GET STATISTICALLY AN APPARENTLY SIGNIFICANT RESULT. THAT APPROACH OFTEN LEADS TO ERRONEOUS FALSE POSITIVES AND NEEDS TO BE CONTROLLED. BUT AT THE SAME TIME SAYING THERE IS AN EXPLORATORY STUDY AND UNDERSTANDING OPENING UP NEW TERRITORY, IS IMPORTANT FOR NIH. I WANT TO MAKE A COUPLE OF FINAL COMMENTS ABOUT THE -- SOMETHING THAT HAS BEEN TROUBLING ME AND CSR. WE HAVE NIH HAS BEEN BLESSED IN AN IMPORTANT WAY. IN THAT UNLIKE MANY AGENCIES WE HAVE NOT SEEN WE SERE CUTS OVER THE LAST 14 YEARS. HOWEVER WE HAVE SEEN A GNAT BUDGET SINCE THE ENDING OF THE -- IN 2003 OF THE DOUBLING OF THE NIH BUDGET. THIS IS MEANT THAT WE HAVE HAD A LONG TERM SCIENTIFIC RECESSION, WE HAVE TO BE THANKFUL THAT IT'S NOT WORSE -- AS BAD AS OTHER AGENCIES HAVE EXPERIENCE, WE HAVE BEEN LUCKY THAT CONGRESS HAS BEEN VERY APPRECIATIVE OF WHAT NIH HAS PRODUCED. THIS HAS HAD SOME SIDE EFFECTS. CAN ONE IS THAT THE SCIENTIFIC POPULATION HAS RESPONDED BY INCREASING APPLICATION RATE BECAUSE OF THE REDUCED NUMBER OF AWARDS AND THE DIFFICULTY IN GETTING AWARDS. THIS COMBINATION OF HIGH APPLICATION NUMBERS AND FLAT BUDGET HAS LED TO THIS SORT OF SUCCESS RATE. NIH HAS DONE A LOT TO TRY AND ADJUST THINGS BUT IT MEANT SINETISES HAVE HAD THE LIVE NEAR TO THE EDGE. THIS LED TO SOME OF THE PROBLEMS AROUND RIGOR AND REPRODUCIBILITY. SO I CAME TO NIH IN 1979 WHEN WE JUST HIT 40% SUCCESS RATES NOW WE ARE LESS THAN HALF OF THAT, IN 2016 WE WILL BE BETWEEN 19 AND 20%. AT THE SAME TIME I WOULD LIKE TO HAVE FOR A SENSE OF PERSPECTIVE, I HAD GONE TO THINE TO TALK TO THEM ABOUT -- CHINA TO TALK TO THEM HOW TO DO NIH STYLE PEER REVIEW. AND AT THE NSF CHINA NATURAL SCIENCES FOUNDATION CHINA WHICH IS THEIR EQUIVALENT OF NSF U.S., THEY SHOWED ME THIS BUDGET FIGURE FOR 1986 THROUGH 2014, ALMOST A 30 YEAR SPAN OF TIME. 1986 TO 2014. THIS BUDGET TREND REFLECTS DOUBLING OF THEIR SCIENCE BUDGET IN NSF CHINA, EVERY FIVE YEARS FOR 30 YEARS. SO AT THAT YEAR THEY WERE HALF THE NSF BUDGET AND DECLARED THE NEXT TO PASS THE NIH IN THE NEXT FIVE YEAR PERIOD OF TIME. I DON'T KNOW IF -- HOW FAR THEY'VE PROGRESSED ON THIS, THEY HAVEN'T GIVEN ME AN UPDATE OF THIS SLIDE. THIS IS THE -- AT THE SAME TIME THIS IS THE CHINA GDP IN CURRENT U.S. DOLLARS. AND AT LEAST CHINESE SCIENTISTS THAT I TALKED TO BELIEVE THERE WAS A CONNECTION BETWEEN THESE -- THERE IS A CONNECTION BETWEEN GDP AND INVESTMENT. THIS IS A THOUGHT THAT I'LL LEAVE IN YOUR HEADS AS WE -- AS I END MY TALK. THANK YOU VERY MUCH. [APPLAUSE] >> GREGORY, THEN DR. REGENSTEINER. >> GREAT, I APPRECIATE THE COMMENTS. I WANT TO ASK A QUESTION ABOUT THE NIH AND THE STUDY SECTION AND IMPLICIT BIAS. ONE SUGGESTION IS THOSE THREE QUESTIONS FOR DEBRIEFING I PUT THEM IN REVERSE ORDER IF IT'S NOT TOO LATE. >> WE NEATER COMMITTED TO THAT. -- WE'RE NOT COMMITTED TO THAT. >> I DO THINK THAT A LOT OF PEOPLE WILL KNOW WHO THE PEOPLE ARE. WHAT I WANT TO SAY IS TWO THINGS. ONE BEING STUDY SECTION THAT GROUPS DISCUSSION IT FORCES IT INTO A MODIFIED -- IF YOU'RE NOT SCORING BETWEEN ONE OR TWO POINTS THEN IT'S EXTRA WORK TO DEFEND WHY SCORING OUTSIDE THE RANGE. AND FREQUENTLY IT'S THE STRONGEST PERSONALITY THAT WINS THAT DISCUSSION. AND WHAT I THINK IS THERE'S ACTUALLY AN EXPLICIT BELIE BIOIAS IN FAVOR OF THE MAJORITY. AND THAT SOMETIMES APPLICATION MAY NOT NECESSARILY BE VERY GOOD. BUT IT'S BY A VERY GOOD RESEARCHER AND WHAT YOU WILL HEAR IS YOU KNOW IT'S A GOOD TEAM, YOU KNOW IT'S A GOOD PLACE. SO EVERYONE ELSE, THE NEW PEOPLE SORT OF GET BULLIED. AND TO CHANGING THEIR SCORE. SO I WANT TO SET THAT OUT, I DON'T KNOW WHAT THE CURE IS OR THE SOLUTION BUT I CAN SAY THAT IT'S AN OBSERVATION. >> YES. THERE'S NO QUESTION THERE IS THAT. THERE ARE THOSE WHO FEEL THAT KNOWING THE TRACK RECORD OF A SCIENTIST AND RAISING IT IS AN ISSUE IS LEGITIMATE. THERE ARE THOSE WHO FEEL PARTICULARLY YOUNGER SCIENTISTS OR THOSE WHO HAVE SHORTER TRACK RECORDS, WHO FEEL THAT THAT'S BEING USED TO MAINTAIN THE DOMINANCE OF THE MORE SENIOR SCIENTIST. I THINK THAT'S AN ONGOING ISSUE AND SHOULD BE LOOKED AT AND WE SHOULD TRY AND JUDGE SOME OF THOSE ISSUES. WHAT WE -- WE HAVE TAKEN A LOOK AT PRELIMINARY SCORES COMPARED T FINAL SCORES FOR DIFFERENT GROUPS. AND I HAVE NOT PARTICULARLY LOOKED AT PRELIMINARY SCORES VERSUS FINAL SCORES SENIOR SCIENTISTS VERSUS JUNIOR SCIENTISTS. YOUR POINT IS THAT I SHOULD DO THAT. WHAT WE DO NOT SEE IS THAT FOR WOMEN OR MINORITY SCIENTIST THERE IS IS A CHANGE IN THEIR SCORE NEGATIVELY AS A RESULT OF THAT DISCUSSION. OR MORE POSITIVELY FOR THE RIGHT SCIENTIST AS A RESULT OF THAT DISCUSSION. THE OVER ALL VARIANTS ACCOUNTED FOR -- SEEMS TO BE SET IN THE PRELIMINARY SCORE BY THE WAY PRELIMINARY SCORE ALSO COUNTS FOR WHETHER OR NOT INITIAL DISCUSSION -- DISCUSSION TAKES PLACE AND AFRICAN AMERICAN SCIENTISTS ARE DISCUSSED ABOUT 25% OF THE TIME. SO WE THINK THAT THAT PRELIMINARY SCORE PHASE IS REALLY IMPORTANT. IT WILL DOUBLE OUR COST TO BRING PEOPLE IN TO GET DISCUSSION. WE'LL GET RELATIVELY LITTLE OUT OF IT AT LEAST AT THIS STAGE, WE WILL START WITH TRYING TO GET AN ANSWER TO THE QUESTION, WHAT'S HAPPENING AT THIS PRELIMINARY SCORE PHASE. LET ME SAY ONE OTHER THING ABOUT WHEN I SHOW THOSE SLIDES SHOWING HOW AWFUL SUCCESS RATES ARE THESE DAYS, ET CETERA, I'M OFTEN TOLD THAT THIS IS VERY DISCOURAGING TO SCIENTISTS GENERALLY BUT ALSO PARTICULARLY TO YOUNG SCIENTISTS THINKING ABILITY ESTABLISHING NEW CAREERS. I WANT TO MAKE THE POINT THAT I HAVE BEEN FOLLOWING MANY YOUNGER SCIENTISTS. MANY WHOM DON'T MAKE IT TO DO BENCH WORK. EVERY ONE OF THEM WHO COMPLETED THEIR Ph.D. OR M.D., BEGUN A CAREER, EVERY ONE HAS ENDED UP WITH A GRATIFYING CAREER. SO THIS ISN'T UNEMPLOYMENT OR NEAR UNEMPLOYMENT FLIPPING BURGERS BECAUSE YOU COULDN'T MAKE IT TO THE BENCH, THESE ARE JOBS IN INDUSTRY, THESE ARE JOBS IN GOVERNMENT, THESE ARE JOBS OFTEN IN RELATED AREAS OF BUSINESS WHO NEED PEOPLE WHO CAN SOLVE PROBLEMS. SO THEY SOLVE THEIR OWN CAREER PROBLEMS AND WHAT WE NEED TO DO AMONG OTHER THINGS IS TO ADD TO THE LIST FOR THEM WHAT CAREERS YOU CAN HAVE BECAUSE THESE ARE REAL OPPORTUNITY CAREERS. YES. >> I WAS ONE OF THE FEW SO THRILLED SEX IS A BIOLOGICAL VARIABLE WAS ADDED TO ONE OF THE CONSIDERATIONS BUT IF IT'S -- FOR OTHER FACTORS AS WELL, NOT PART OF THE IMPACT SCORE, THE IMPACT OF THAT DISCUSSION IS LESSER BECAUSE YOU CAN STILL GET FUNDED WHETHER OR NOT YOU CONSIDER BOTH SEXES. SO I THINK THERE NEEDS TO BE MORE THOUGHT GIVEN TO HOW MUCH -- TO PUT TEETH IN THE RECOMMENDATION OTHERWISE I DON'T KNOW THAT IT WILL TRULY CHANGE. >> SO IT'S PART OF THE SIGNIFICANCE CRITERION AND WE DO ASK REVIEWERS TO TAKE INTO ACCOUNT CONSTRUCTING THEIR IMPACT SCORE. NOT MEANT TO BE LEFT OFF OF THAT. ONE MORE, IMENT OOH SEEING THAT BEING TAKEN SERIOUSLY. >> DR. WEAVER THEN DR. -- WHO IS DR. GREEN AND DR. WEAVER. THEN DR. LOPEZ. THEN EMORY. >> SORRY. >> CARMEN, THEN WE'LL GO TO PATTY. >> SO I HAVE ALWAYS BELIEVED PEOPLE SHOULD BE ABLE TO DREAM BIG AND THEIR CHALLENGE AND HARD WORK SHOULD BE ABLE TO TAKE THEM AS FAR AS POSSIBLE. I'M A LITTLE DISTURBED, I HAVE BEEN DISTURBED FOR A WHILE AS RELATES TO GINTHER REPORT. FIRST OF ALL, I'M NOT CERTAIN SATISFACTORY FOR ME TO SET HERE THAT WHEN PEOPLE MAY HAVE TRIED TO DO CERTAIN THINGS THERE'S BIAS WITHIN THE SYSTEM, THEY GET TO GO AND DO SOMETHING ELSE. THAT IS NOT SATISFACTORY TO ME, I PUT THIS OUT THERE, NOT CERTAIN THAT'S HOW YOU MINT IT. I RECOGNIZE THERE'S COMMONNESS BETWEEN THE TWO OF US. BUT I THINK WE LOST A GENERATION OF SCIENTISTS. WHO COULD POTENTIALLY HELP WITH LOTS OF ISSUES BEYOND DIVERSITY AND EQUITY. WE HAVE LOST GENERATION OF PEOPLE WHO WALKED AROUND THINK THEY CAN JUST WEREN'T GOOD ENOUGH. IN ACTUALITY THEY WERE GOOD ENOUGH AND MAY HAVE BEEN BETTER THAN ENOUGH SO I JUST THINK THAT'S AN IMPORTANT TO RECOGNIZE. ONE. THE OTHER THING I WOULD SAY IS THAT THERE'S A CONVERSATION THAT NEEDS TO BE HELD. AS IT RELATES TO THE CONCEPT, THE MODEL AS RELATES TO WOMEN, MINORITIES, AND MINORITY WOMEN. AND I THINK THERE ARE -- SO WHEN YOU PRESENT THIS PARTICULAR DATA WOMEN OF COLOR JUST PUT INTO THAT PARTICULAR CATEGORY. WOMEN OF COLOR ARE INCORPORATED WITHIN THE MEN AND ACTUALITY WE KNOW THERE MAYBE SPECIFIC CHALLENGES FOR THAT PARTICULAR POPULATION. I WOULD LIKE TO SEE AS YOU MOVE FORWARD WITH ANIMATION STUDY, OR LOOK AT THE DATA THAT WAS DONE FOR GINTHER, LOOK AT ASSOCIATION OF RACE. AND GENDER. AND HOW THOSE TWO CAUSE INTERPLACE HOW WHO GETS FUNDED. THE OTHER THING I WOULD POINT OUT IS AS TO WHETHER OR NOT WE HELD THINGS STABLE AS RELATES TO THE SAME TYPE OF INSTITUTION. BUT IS THAT TYPE OF INSTITUTION, SO I COULD PICK -- PICK ON THE UNIVERSITY OF NORTH CAROLINA. IF SOMEONE COMES TO UNIVERSITY OF NORTH CAROLINA AS A PHYSICIAN SCIENTIST, WHO STARTED OUT HPCU THE SAME OR ARE THEY BETTER? OR IS THAT UNIVERSITY OF NORTH CAROLINA PROTECTIVE FOR MEN BUT NOT PROTECTIVE AS RELATES TO WOMEN OR MINORITIES. I THINK THOSE ARE IMPORTANT TYPE OF CONVERSATIONS BECAUSE AGAIN, WHO GETS INTO THOSE INSTITUTIONS AND WHY. HOW LONG DOES IT TAKE THEM? MY LAST POINTE THAT WAS MANY HI LAST POINT. SO I'M NOT EXPECTING -- BUT I THINK THAT THE CONVERSATION NEEDS TO GO BEYOND THAT. I AGREE WITH MY COLLEAGUE, IF YOU HAVE SOMEBODY WHO IS AN ADVOCATE FOR YOU IN THE ROOM T THAT CHANGES THE CONVERSATION, THE CHALLENGE IS ARE THERE ADVOCATES IN THE ROOM? WHEN YOU LOOK AT YOUR STUDY SECTIONS, AND HOW THEY'RE SET UP, AND WHO IS LEADING THEM, I'M JUST CONCERNED THAT WE HAVE LUMPED THINGS TOGETHER WHEN IN ACTUALITY I SUSPECT, I HAVE A HYPOTHESIS THAT WHEN WE LOOK AT WOMEN OF COLOR, IT WOULD BE DISMAL SO I'LL LEAVE IT THERE. >> GINTHER ET AL DID LOOK AT THE ISSUE OF WOMEN AND WOMEN OF COLOR. HER CONCLUSION WAS THAT THE DIFFERENCE BETWEEN AFRICAN AMERICAN WOMEN AND OTHER WOMEN WAS ENTIRELY DUE TO RACE. IT WASN'T A DOUBLE BURDEN IN HER STATISTICS OF BEING WOMAN AND BLACK. THAT DOESN'T MAKE IT BETTER BUT IT THAT WAS HER OVERALL ANALYSIS. I THINK IN EACH CASE WE LOOK AT THIS WE'LL HAVE TO RELOOK AT IT TO MAKE SURE IT REMAINS, THAT IS THE ISSUE. LET ME MENTION BRIEFLY NIGMS FUNDED ANOTHER STUDY AT THE UNIVERSITY OF WISCONSIN IN WHICH A DIFFERENCE WAY OF LOOKING AT THIS WILL TAKE PLACE. SOMEONE IS DOING A STUDY THERE TO TAKE THE EXACT SAME APPLICATIONS, GRANT APPLICATIONS, PUTTING PLAQUE AND WHITE FACES ON THEM, ASKING A QUESTION, IS THERE A DIFFERENCE IN THE SCORE. THAT'S THE STRONGEST WAY OF LOOKING FOR GUY BIOIAS, WE FELT CSR COULDN'T SPONSOR A STUDY IN WHICH WE DECEIVED OUR REVIEWERS ABOUT WHAT WAS GOING ON. APPRECIATED THE FACT THAT AN OUTSIDE -- SOMEONE ELSE PROPOSED THIS STUDY BECAUSE WE THINK THAT THAT'S A GOOD OMPLIMENT TO WHAT WE'RE DOING. FOR OTHER KINDS -- I CERTAINLY WAS NOT SAYING THAT INDIVIDUALS SHOULD BE PUSHED TO SETTLE SO MUCH AS THAT WE'RE FINDING SCIENTISTS SAYING WHO DISCOVERED ALTERNATIVE CAREERS. I DID NOT KNOW I COULD HAVE A FULFILLING LIFE AND CAREER. AWAY FROM THE BENCH. I HAD BEEN SOLD ON THE IDEA THAT THE ONLY CAREER POSSIBLE WAS AS A BENCH SCIENTIST. WE'RE NOT SAYING PEOPLE SHOULD DO WHAT THEY DON'T WANT TO DO. BUT WE DO THINK THERE ARE GREAT CAREERS OUT THERE THAT THIS COUNTRY NEEDS. >> SO I THINK WE ALL HAVE TO DO DUE DILIGENCE ABOUT RIGOR AND REPRODUCIBILITY. NIH MADE GREAT STRIDES IN THAT AREA. SHOWED LEADERSHIP. BUT I WONDER IF THERE'S ANY EVIDENCE THAT OUTSIDE OF NIH THERE IS MORE REPRODUCIBILITY. CERTAINLY ON MY FIELD INDUSTRY SPONSORED RESEARCH THEY DON'T HAVE LARGER TRIALS MORE GENERALIZABLE, THAT WOULDN'T BE THE ASSUMPTION THAT THERE WOULD BE REPRODUCIBILITY. HOW DO YOU SORT BIOLOGICAL VARIABILITY OR DIFFERENT COHORTS THAT COULD GIVE DIFFERENCES WHEN THEY TRY TO BE REPEATED WITH GOOD READER. POOR SCIENCE. >> THERE'S BEEN INTEREST IN WHAT CAUSES VARIABLES IN STUDIES AND THAT'S WHY SEX REMAINS SO IMPORTANT. BUT STRESS, CONDITIONS LOTS OF THINGS WE KNOW HAVE INFLUENCE WE HAVE TO DO A BETTER JOB AS SCIENTISTS TO UNDERSTAND WHAT THOSE SOURCES OF VARIABILITY ARE. AND TAKE THEM INTO ACCOUNT EVEN KIND OF FOOD GIVEN TO ANIMALS MAY MAKE A DIFFERENCE. OR THEIR MOCKER ENVIRONMENT. SO YES, THOSE ARE FACTORS. AND AS THINGS GET MORE COMPLEX, SO TOO ARE THE KINDS OF THINGS THAT MESS UP RESULTS OF THIS STUDY. WE JUST NEED TO DO A BETTER JOB THOUGH OF HAVING THINGS SUFFICIENTLY ROBUST TO USE MORE THAN ONE SPECIES OF ANIMAL, MORE THAN ONE CONDITION IN ORDER TO TRY AND SEE HOW GENERALIZABLE ANY GIVEN STUDY CAN BE. >> JILL THEN EMERAN AND THEN WE HAVE TO TAKE THOSE LAST TWO QUESTIONS, I'M SORRY. >> >> SO JUST RETURNING TO THE QUESTION OF SEX AS BIOLOGICAL VARIABLE, I JUST WANT TO SAY WHAT I HAVE HEARD FROM STUDY SECTIONS IS THE CONCERN ABOUT EXPERTISE ON STUDY SECTIONS THAT ARE ABLE TO ACTUALLY EVALUATE THE INCLUSION OF BOTH MALES AND FEMALES IN THE STUDIES THAT ARE BEING EVALUATED. SO I'M REALLY ENCOURAGED CSR TO FIND WAYS TO INCREASE REPRESENTATION ON STUDY SECTIONS OF INDIVIDUALS WHO HAVE SEX DIFFERENCES EXPERIENCE IN PORTFOLIO AS WELL AS EXPERIENCE STUDYING FEMALES, IF ONLY MALES HAVE BEEN STUDIED. >> IF YOU HAVE -- IF ANY REVIEWER COMES ACROSS COMMITTEE WHICH THEY HAVE CONCERNS ABOUT WHAT'S GOING ON, PLEASE WRITE TO ME AND I WILL ASK STAFF TO LOOK INTO IT AND TRY AND MAKE ADJUSTMENTS. WE CHANGE OUR COMMITTEES EVERY YEAR. >> NEXT QUESTION TO DR. MAYER. >> YOU MADE -- MENTION SOME OF THESE AREAS WOULD HINDER IMPLEMENTATION OF STUDYING SEX DIFFERENCES. ONE OF THE BIGGEST ONES THAT DID MENTION IS THE COST OF STUDYING, CLINICAL STUDIES NOT THAT EXPENSIVE TO ADD SAMPLE SIZE WITH MICE. WITNESS YOU GET INTO CALCULATIONS FOR STUDIES, REALIZE SUBGROUPS OF DISEASES NOW, WE HEARD ABOUT PERSONALIZATION OF MEDICINE, SO BECASE EXTREMELY EXPENSIVE TAKING AND WITH THE CURRENT BUDGET SITUATION IT'S NOT THE MOST EXCITING THING FOR REVIEWER TO SAY, DOUBLE SAMPLE SIZE BUT THE INTELLECTUAL CHALLENGE IN THAT GRANT IS NOT THAT GREAT. I PERSONALLY THINK I HAVE SEEN THIS OVER AN OVER AGAIN, SO WE NEW CLIENTS -- WE KNOW BEFOREHAND THERE'S NOT ENOUGH MONEY TO DO THE MALE AND FEMALE POPULATIONS. AS THEY SHOULD BE DONE SO WE GO INTO THAT AND AT THE END RUN INTO CRISES AND LOOK FOR ALTERNATIVE FUNDINGS, TO ME THAT'S THE MAIN -- WHEREVER YOU GO YOU HEAR THIS DISCUSSION, PHENOTYPING, LARGE SAMPLE SIZES SUBGROUPING, MACHINE LISTENING APPROACHES -- LEARNING APPROACHES. SO EQUAL NUMBER OF FEMALES IN IT BECOMES UNAFFORDABLE. >> I THINK IN THE END WE HAVE TO PROPOSE AND DO GOOD SCIENCE, IF IT COSTS MORE I RECOGNIZE THAT SQUEEZE SCIENTISTS ARE IN. THERE'S -- IF YOU ASK FOR THE FULL BUDGET YOU NEED, YOU MAY NOT GET THE AWARD BECAUSE IT'S TOO EXPENSIVE. AT THE SAME TIME WE AS A COMMUNITY NEED TO WORK THROUGH SOME OF THESE PROBLEMS BECAUSE DOING BAD OR UNREPLICABLE SCIENCE IS WORSE. COMPLETE WASTE OF MONEY SO WE NEED TO FIGURE HOW TO GET THIS ACCOMPLISHED IN A WAY THAT EACH STUDY COUNTS. I DON'T HAVE AN ANSWER. I DO AGREE THAT WE NEED NOR MONEY. THANKS. >> ANOTHER POINT TO THIS, IN TERMS OF THE HUMAN STUDIES, DO YOU THINK THE RO1s TYPICAL RO1 MODEL CANNOT FUR FILL THOSE CHALLENGES AND CONSORTIUM MORE SUITABLE TO ADDRESS -- >> ENTERED INTO ANOTHER HOUR LONG TALK. SO I'M NOT GOING TO BE ABLE TO ANSWER THAT QUESTION BUT WE CAN ANSWER -- >> PLEASE JOIN ME IN THANKING DR. NAKAMURA FOR A FANTASTIC PRESENTATION. [APPLAUSE] THANK YOU VERY MUCH, RICHARD. OUR NEXT PRESENTER IS DR. MONICA BASCO, NEW ASSOCIATE DIRECTOR FOR SCIENCE POLICY PLANNING ANALYSIS, SO PLEASE JOIN ME IN WELCOMING DROP BASCO. >> THANK YOU, I'M GLAD TO JOIN YOU TO TELL YOU WHAT MY TEAM IS DOING. ARE YOU STILL THERE, GEERT? WE'RE HAVING A LITTLE TECHNICAL ISSUE THERE. WHILE WE'RE DOING THAT. >> GEERT, DID YOU HAVE COMMENTS OR QUESTIONS ON ANYTHING? MAYBE ON MUTE. MONICA, GO AHEAD. >> A LITTLE GLITCH THERE. SO I WAS WITH CSR AND DR. KNOCK RA WORKING ON THIS FOR SEVERAL YEARS AND HAPPY TO BRING SOME POLICY EXPERT'S NAKAMURA, POLICY TO WOMEN'S HEALTH. >> I'M HERE. >> I ALSO WANTED TO -- >> I'M HERE BUT THERE IS A DELAY. >> OKAY. THANK YOU, STAND BY. >> INTRODUCE YOU TO MY TEAM, THEY'RE SITTING HERE IN THE BACK. MELISSA GIM IS LEADING OUR WORK ON LIMITED BIOMEDICAL CAREERS (INDISCERNIBLE) IS OUR STATISTICAL DESIGN EXPERT AND DOES PROGRAM EVALUATION AND PARIS WATSON IN THE BACK IS OUR POLICY LEGISLATION EXPERT ALSO WORKING ON INCLUSION AND OUTREACH. SO WANTED TO LET YOU KNOW I WAS FORTUNATE TO INHERIT A WONDERFUL GROUP. I WANT TO GIVE A FLAVOR FOR THINGS OUR GROUP IS WORKING ON. PROBABLY MOST IMPORTANT TO THIS GROUP IS WE HAVE STARTED OUR PLANNING FOR THE NEXT ORWH STRATEGIC PLAN. WE HAVE A GENERAL STRATEGY IN PLACE WHERE WE'LL TRY TO MAKE USE OF THE WONDERFUL RECOMMENDATIONS, MADE BY THIS GROUP AND OTHERS, THE COURSE OF YOUR DELIBERATIONS AS THE LAST STRATEGIC PLAN WAS PUT INTO PLACE. WE WILL BE SEEKING INPUT FROM YOU, WE WILL HAVE MORE DETAILS TO FOLLOW BUT ALSO FROM OUR OTHER WORKING GROUPS, COORDINATING COMMITTEES AND THE NIH INSTITUTE CENTERS AND OFFICES AS WELL. AT SOME POINT WE WILL PUBLISH AN RFI SO THE SCIENTIFIC COMMUNITY CAN WEIGH IN ON OUR IDEAS FOR STRATEGIC PLANS, WE'LL LAY OUT NUMBER OF IDEAS AND GET INPUT. AND WE WILL ALSO BE GAINING INSIGHT ON CLOE BIRD'S RAISING THER BAY. OUR GENERAL PLAN IS TO HAVE A DRAFT REPORT TO YOU BY YOUR SEPTEMBER MEETING. THAT'S OUR GOAL. WITH A FINAL REPORT EARLY IN 2018. ANOTHER BUSINESS TASK FOR OUR GROUP, PULL TOGETHER THE BIANNUAL REPORT OF THIS COMMITTEE. SOME OF YOU MAY WORKED ON THE LAST BIANNUAL REPORT, THE NEXT WILL BE COVERING FISCAL YEARS 2015 AND 2016, IT WILL INCLUDE A RESEARCH PROGRESS MUCH OF WHICH JANINE COVERED TODAY. IT WILL INCLUDE SEX AND MINORITY INCLUSION DATA FROM ACROSS THE INSTITUTES AND CENTERS AS WELL AS REPORTS FROM THE THOSE CENTERS. THERE IS SOME -- GOING TO BE A MOVE TO A TRIANNUAL FRAME FOR OUR REPORTING REPORTENING THE FUTURE, MORE ABOUT THAT IN A SECOND. I WAS ASKED TO GIVE A BRIEF UPDATE ON THE 21st SENSORY CURE ACT HOW IT AFFECTS THE WORK THAT WE DO. IN THE OFFICE OF RESEARCH ON WOMEN'S HEALTH. I WANTED TO HIGHLIGHT A COUPLE OF THINGS THAT ARE IMPORTANT. ONE SECTION OF THE ACT 2031 REAR INSTITUTES AND DIRECTORS TO CONSULT ANNUALLY NOT ONLY WITH THE OFFICE OF RESEARCH ON WOMEN'S HEALTH BUT INSTITUTE FOR MINORITY HEALTH AND HEALTH DISPARITIES TO MAKE SURE THEIR IC INDIVIDUAL MISSION AND GOALS TAKE INTO CONSIDERATION WOMEN AND RACIAL ETHNIC GROUPS AND ALSO HAVE A FOCUS ON HEALTH DISPARITIES AS WELL ADDRESSING THOSE ISSUES. ONE OF THE SECTIONS IN THE ACT HAS ASKED NIH TO MOVE TO TRIANNUAL REPORTING, HOWEVER IT DIDN'T INCLUDE A MENTION OF THIS OFFICE. SO WE HAVE TO WORK OUT THAT GLITCH THAT SEEMS TO SUGGEST TO CONTINUE ON BIANNUAL BASIS SO MAYBE A DELAY GETTING TO YOU THE REPORT THAT WE NEED BECAUSE WE'RE TRYING TO NAIL DOWN WHAT'S GOING TO BE REQUIRED OF US AND HOW TO GET THE DATA THAT WE NEED TO PROVIDE THAT REPORT. SO ONCE WE WORK THAT OUT, WE WILL LET YOU KNOW, KEEPING YOU INFORMED AND ASKING YOU THE READ THROUGH THOSE REPORTS FROM THE INSTITUTES AND CENTERS AS WELL AS DATA AND TAKE A LOOK AND GIVE US YOUR INPUT. ANOTHER SECTION 2038 OF THE ACT WILL REQUIRE THE NIH DIRECTOR TO UPDATE GUIDELINES OF INCLUSION OF WOMEN ON CLINICAL RESEARCH TO KEEP UP WITH THE CURRENT SCIENCE THAT SHOULD EVOLVE OVER TIME AS WE AS GUIDELINES REGARDING SEX AS BIOLOGICAL VARIABLE SO THE CONTINUED TO UPDATE THAT INFORMATION AS WE LEARN MORE. THERE IS ALSO REQUIREMENT NIH DIRECTOR HOLD A WORKSHOP TO SOLICIT INPUT ON APPROPRIATE AGE GROUPS AND CONSIDER HOW WE RECORD AGE OF PARTICIPANTS ACROSS STUDIES. TOE THAT END WE HAVE A WORKSHOP PLANNED JUNE 1st AND 2ND INCLUSION ACROSS THE LIFE SPAN INCLUDING PRESENTATIONS BY NIH AND FDA REPRESENTATIVES AS WELL AS QUITE A BIT OF TIME FOR DISCUSSION GROUPS WITH SUBJECT MATTER EXPERTS ON THESE VARIOUS AREAS, THE GOAL TO FOCUS ON THE INCLUSION OF PARTICIPANTS AT THE YOUNGER AND OLDER AGE, RANGES. THE TOPICS OF DISCUSSION WILL INCLUDE THINGS LIKE STUDY DESIGN AND METRICS. AGE RESTRICTIONS ETHICAL ISSUES RELATED TO RECRUITMENT IN THOSE GROUPS. HOW TO DO DATA OR AGE SPECIFIC SUBGROUP ANALYSES AND HOW TO REPORT THOSE OUTCOMES. SO SHOULD BE VERY INTERESTING AND MORE INFORMATION WILL COME TO YOU. YOU CAN ATTEND VIRTUALLY, IT WILL BE WEBINAR FORMAT AS WELL AS MAY ATTEND HERE IN PERSON IF YOU HAVE NOT ALREADY EXPRESSED INTEREST, IT WILL BE AN ONLINE REGISTRATION AVAILABLE. I KNOW YOU'RE FAMILIAR WITH H NIH WORKING GROUP ON WOMEN IN BIOMEDICAL CAREERS. THAT GROUP WHICH CONSISTS OF VARIOUS AREAS OF BIOMEDICAL SCIENCE AND WORKING GROUP IS BY DR. COLLINS AND CLAYTON, CREATES A NEWS LETTER TO HIGHLIGHT POSITIVE SCIENCE RELATING TO WOMEN'S HEALTH AS WELL AS SHOWCASE WOMEN SCIENTISTS UP AND COMING SCIENTIST, SHOWCASES JOBS AVAILABLE TO WOMEN AND SCIENCE. ANOTHER SUBCOMPONENT OF THE WORKING GROUP IS RESEARCH PARTNERSHIP, GROUP OF PRINCIPLE INVESTIGATORS THAT RESPONDED TO THE RFA ON CAUSAL FACTORS AND INTERVENTIONS FOR UNDERSTANDING AND IMPROVING RECRUITMENT RETENTION ADVANCEMENT OF WOMEN AND SCIENCE, THEY CONTINUE TO BE VERY ACTIVE, THEY WILL DO A PANEL AT AAMC, JENNY WILL TALK WITH THEM AND THEY WILL CONTINUE TO DO MORE RESEARCH TOGETHER AS A GROUP OF PIs. SO THAT'S GOOD. PRETTY COOL. THERE GOES. THAT'S OUR WEBSITE WHICH WILL BE INDATED, WE'LL TRY TO DO MORE COMPREHENSIVE NEWS LETTER THAT ALLOWS TO REPORT TO Y'ALL AND OTHER STAKEHOLDERS ABOUT THE PROGRESS ACROSS THE ACTIVITIES OF THE WORKING GROUP. ONE SUBGROUP OF THE WORKING GROUP IS THE WOMEN OF COLOR COMMITTEE, A VERY ACTIVE GROUP, THEY'VE WON BIG SUCCESS THIS GROUP HAD WORKING WITH THE SPECIAL POPULATIONS RESEARCH FORUM TO GET MORE WOMEN AND MEMBERS OF UNDER-REPRESENTED RACIAL ETHNIC GROUPS AS SPEAKERS IN THE PROMINENT DIRECTORS NIH DIRECTORS WEDNESDAY AFTERNOON LECTURE SERIES. WE HAVE JUST RECENTLY HOSTED LINDA BUCK, NOBEL PRIZE WINNER. >> YOUR CONVERSATION CONTAINS LESS THAN THREE PARTICIPANTS. >> AND WE ARE OAR VERY PLEASED TO BE ABLE TO HAVE (INAUDIBLE). (OVERLAPPING SPEAKERS) WE HAVE THE -- ONLY COMPONENT IS CREATION OF WOMEN OF COLOR RESEARCH NETWORK, IT HAS EXPANDED ITS MEMBERSHIP AND IS TO PROVIDE AN OPPORTUNITY FOR NETWORKING AS WELL AS SHARING OF RESOURCES. THEY NOW HAVE A LINKED IN GROUP AND THE GROUPS HAVE CREATED FOUR REGIONAL CHAPTERS, THERE ARE TWO IN PLAY CURRENTLY, NORTH CAROLINA AND INDIANA I BELIEVE. AND TWO MORE COMING UP IN WASHINGTON D.C. AND BALTIMORE, MORE PEOPLE ARE VERY INTERESTED. ANOTHER THING WOMEN OF COLOR COMMITTEE IS FOCUSED ON IS GIVING -- PROVIDING A VENUE FOR YOUNG SCIENTISTS AT THE NIH WHO HAD SUCCESS EITHER STEADMAN SCHOLARS OR OTHER EXPERIENCES HERE AS PART OF THE INTRAMURAL RESEARCH STAFF, MOST RECENTLY DR. ANDREA PAULA WAS ABLE TO PROVIDE HER PRESENTATION OF HER WORK ALLOWS US TO INCREASE NETWORK OF THOSE INDIVIDUALS AS WELL AS KEEP US INFORMED OF THE GREAT WORK WOMEN OF COLOR ARE DOING HERE AT THE NIH. THAT'S ALL I HAVE FOR TODAY. DO WE HAVE TIME TO TAKE QUICK QUESTIONS? QUICK QUESTIONS? PERFECT. I DON'T WANT TO STAND BETWEEN YOU AND LUNCH. >> THANK YOU VERY MUCH. >> THANK YOU VERY MUCH, MONICA. [APPLAUSE] >> I WANT TO HIGHLIGHT OUR OWN DR. LOUISE MCCULLOUGH WILL BE GIVING A WALS LECTURE SOON. >> I WILL. (OFF MIC) >> WE'LL REALLY BE EXCITED ABOUT THAT. WE WILL MAKE SURE ADVISORY COMMITTEE KNOWS ABOUT THAT. SO IF EVERYBODY -- COUPLE OF ANNOUNCEMENTS. THE ADVISORY COMMITTEE MEMBERS IF YOU WOULD STAY A SECOND BEFORE YOU BREAK FOR LUNCH FOR A PHOTOGRAPH, THAT ONE GREAT. ALL MEMBERS. AND EVERYONE ELSE IS EXCUSED. THERE'S A CAFETERIA ON THE FIRST FLOOR AS YOU KNOW. ADVISORY COMMITTEE MEMBERS NOT SIGNED UP FOR A TAXI, PLEASE SEE MR. BOB BY GIBSON TO DO SO. OTHERWISE WE ARE ADJOURNED FOR LUNCH AND WE WILL BE BACK HERE AT ONE O'CLOCK. THANK YOU, GEERT, ON THE PHONE. YOU MIGHT WANT TO HANG UP AND DIAL BACK IN. ISLE TRY TO GIVE YOU AN OPPORTUNITY TO ASK QUESTIONS IN THE AFTERNOON. THANK YOU, EVERYBODY. SEE YOU AT 1:00. --DR. IRWIN WILL BE INTRODUCING OUR NEXT SPEAKER. GOOD AFTERNOON. EVERYONE, WELCOME BACK TO LUNCH. IT'S MY PRIVILEGE TODAY TO INTRODUCE MR. JOHN BURKLOW, HE IS BEEN WITH NIH SINCE 2002. PRESENTLY SERVES AS DIRECTOR FOR THE OFFICE OF COMMUNICATIONS AND PUBLIC LIAISON AND CHIEF ADVISOR TO THE NIH DIRECTOR. MR. BURKLOW SERVES AS THE LEAD SPOKES PERSON FOR THE NONSCIENTIFIC MATTERS, HE ALSO OVERSEES NEWS MAIDIA AND EDITORIAL OPERATIONS ONLINE COMMUNICATIONS AND SO MUCH MORE. ACCORDING TO THE NIH WEBPAGE ON ASSOCIATE DIRECTORS HE HAS THE LONGEST TENURE OF ANY CURRENTLY ACTIVE A. D. SO THANK YOU SO MUCH JOHN FOR YOUR MULTIPLE YEARS OF DEDICATED PUBLIC SERVICE AND LEADERSHIP TO NIH AND OUR NATION. SO TODAY MR. BURKLOW, WILL SPEAK TO US ABOUT COMMUNICATING ABOUT NIH SO PLEASE WELCOME DR. JOHN BURKLOW. >> GOOD AFTERNOON, EVERYONE, I'VE BEEN IN BUILDING ONE SINCE 2002, AND BEEN AT NIH SINCE 1986. SO I'VE BEEN HERE--IT'S JUST THE GYPSY IN ME. SO I WANT TO GO OVER SEVERAL THINGS THIS AFTERNOON. ONE TO GIVE YOU AN OVERVIEW OF OUR OFFICE, THE OFFICE OF COMMUNICATIONS PUBLIC LIAISON. NOW, THERE ARE OFFICES, COMMUNICATIONS OFFICES THROUGHOUT NIH IN EACH OF THE 27 INSTITUTES AND CENTERS AND THEN THE OFFICES WITHIN THE OFFICE OF THE DIRECTOR AND I'LL CONCENTRATE ON WHAT WE DO. SO IT WON'T BE A FULLY COMPREHENSIVE TALK. I ALSO WANT TO TALK ABOUT HOW DR. COLLINS USES COMMUNICATIONS TO ADMIN RECORDS AND VANCE THE NIH COMMISSION AND MAKE THE CASE FOR BIOMEDICAL RESEARCH AND DR. CLAYTON HAS PLAYED AN IMPORTANT ROLE ABOUT THIS IN THE LAST LITTLE BIT. THE LAST PART I'LL TALK ABOUT PRODUCTS AND SERVICES THAT MAY BE OF INTEREST TO YOU. AND I'LL TAKE QUESTIONS AT THE END OR THROUGHOUT, ANY TIME. SO ... AGAIN, WHAT WE DO, SUPPORT THE DIRECTOR OF COMMUNICATIONS, RIGHT NOW DR. COLLINS AND DR.ULARLY TABAK, PRINCIPLE DEPUTY DIRECTOR, WE HELP THEM WITH EVERYTHING FROM PRESENTATIONS TO MEDIA RELATIONS BUT WE ALSO COORDINATE ACROSS THE--ALL THE ICs YOU MAY HAVE HEARD THAT TERM, ICs, INSTITUTES AND CENTERS, AND LAST YEAR WE HAD MORE THAN 5000 PRESS INTERVIEWS AND COORDINATED MORE THAN 5000 ABOUT 350 PRESS RELEASES ACROSS NIH. SO IT'S PRETTY HIGH VOLUME AND WE'RE IN CONSTANT CONTACT WITH THE COMMUNICATIONS DIRECTORS. WE'RE ALSO THE LIAISON WITH THE DEPARTMENT OF HEALTH AND HUMAN SERVICES. WE ALSO TALK TO OUR SIBLING AGENCIES, FDA, CDC, CMS, AND EVEN OTHER DEPARTMENTS, STATE DEPARTMENT AND OTHERS. WE ALSO COORDINATE WITH OUTSIDE ORGANIZATIONS. I MENTIONED THE REPORTERS AND EDITORS, WE'RE ALWAYS IN TOUCH WITH THEM, BY PHONE OR E-MAIL. WE ALSO HAVE THE PUBLIC INQUIRIES SECTION IN OUR OFFICE AS DOES A LOT OF THE INSTITUTES AND CENTERS. WE ALSO DO SCIENCE AND NIH COMMUNICATIONS. THE LAST THING IS FOIA, YOU HAVE PROBABLY HEARD OF THAT, THE FREEDOM OF INFORMATION ACT, PEOPLE CAN REQUEST RECORDS. WE HAVE THE LEAD OFFICE BUT AGAIN WE WORK WITH ALL THE INSTITUTES AND CENTERS. SOCIAL MEDIA, SPECIAL EVENTS, WHEN THE PRESIDENT COMES WE'RE THE POINT PERSON AND POINT OFFICE FOR THAT, THE DALAI LAMA COMES AS HE DID A FEW YEARS AGO, POINT PERSON FOR THAT AS WELL, THAT COULD BE A WHOLE OTHER TALK. JUST TO TELL YOU HOW THAT DAY WENT. IT WAS MAGICAL AND MEMORABLE. ALSO ISSUES MANAGEMENT, KIND OF A CATCH ALL PHRASE FOR A LOT OF THINGS THAT WE DEAL WITH AND OUR KEY MESSAGE IS REALLY SOME ARE VERY--COURSE, YOU KNOW THESE, I DON'T EVEN HAVE TO TELL YOU, THE VALUE OF INVESTING IN MEDICAL RESEARCH, BUT THE KEY WORD IS INVESTING. THAT THE BUDGET FOR MEDICAL RESEARCH IS AN INVESTMENT FOR THE FUTURE. ALSO WHAT KIND OF HEALTH IMPACT DOES NIH HAVE? EVERYTHING FROM FLUORIDE FROM TOOTH DECAY TO HEART DISEASE TO DIABETES, TO CANCER. SO, RARE DISEASES, WHAT'S THE FULL RANGE OF THE IMPACT OF NIH RESEARCH. ALSO THIS, IS A RELATIVELY NEWER MESSAGE IS THE ECONOMIC IMPACT OF RESEARCH, GLOBALLY AND LOCALLY AND ALSO TO TALK ABOUT THE IMPORTANCE OF BASIC RESEARCH IN THE CONTEXT OF BIOMEDICAL RESEARCH AS WELL AS CLINICAL AND TRANSLATIONAL. THE LAST POINT I HAVE IS THE FOOTPRINT OR IMPACT OF NIH AND WE HAVE TO TELL THIS STORY OVER AND OVER THAT NIH IS NOT JUST A PLACE IN BETHESDA, BUT WE SUPPORT MORE THAN 83% OF OUR MONEY GOES OUT TO ALL OF YOU, TO GRANTEE INSTITUTIONS ACROSS THE COUNTRY, AROUND THE WORLD. I REMEMBER A FEW YEARS BACK, A MEMBER OF CONGRESS ASKED THE NIH DIRECTOR, DOC--THEY ALWAYS CALL THEM DOC FOR SOME REASON AND THEY HAVE SOUTHERN ACCENTS TOO--BUT THEY SAID DOC I DRIVE DOWN ROCKVILLE AND I SAY HOW ARE YOU SPENDING 30 BILLION DOLLARS. SO PEOPLE STILL THINK ALL 30 BILLION AND RIELT HERE,--RIGHT HERE, NO, MEMBER OF CONGRESS WHEN YOU GO BACK TO YOUR DISTRICT OR STATE, NIH AS A PRESENCE THERE AS WELL. AND IT'S A STORY THAT HAS TO BE TOLD AND RETOLD. OKAY, I WAS SITTING IN A HEARING A FEW YEARS BACK WITH DR. COLLINS AND CONGRESSMAN SIMPSON SAID, "DR. COLLINS, NIH IS ONE OF THE BEST KEPT SECRETS IN WASHINGTON." AND AS THE COMMUNICATIONS DIRECTOR FOR THE AGENCY I'M SITTING THERE, THINKING THIS IS ONE OF MY PROUDER MOMENTS. [LAUGHTER] MANAGED TO KEEP A 30 BILLION DOLLAR AGENCY A SECRET IN WASHINGTON. SO DR. COLLINS SAID, WELL, YOU KNOW YOU HEARD WHAT HE SAID SO LET'S DO SOMETHING ABOUT THAT. AND SO WE HAVE BEEN PROACTIVE AND TRIED TO BE AS STRATEGIC AS WE CAN. ONE OF THE BASIC THINGS WE DID IS HOW ARE WE PRESENTING OURSELVES TO THE WORLD AND AT THE TIME HE SAID THIS, PROBABLY HAD 700, 800 LOGOS ACROSS NIH. WHO CARES, LET A THOUSAND FLOWERS BLOOM BUT WHEN YOU THINK ABOUT IT WE'RE COMMUNICATING WITH THE WORLD. EVERY TIME WE INTRODUCE OURSELVES WITH A NEW NAME AND NEW LOOK AND WE KEEP EXPECTING PEOPLE TO MAKE THE CONNECTIONINGS THEMSELVES. WE MADE IT PRETTY MUCH IMPOSSIBLE FOR PEOPLE TO UNDERSTAND THE FULL SCOPE OF ACTIVITIES THAT WERE GOING ON AT NIH. SO, I COMMITTED A HERETICAL ACT AND HAD ONE LOGO, ONE MARK ACROSS NIH WITH THE TEXT. AND I KNOW THAT WAS PAINFUL FOR A LOT OF US AND WE HAD OUR OWN LOGOS BUT IT WAS A WAY OF SOLIDIFYING THE MESSAGE AND MAKING IT EASIER FOR PEOPLE TO UNDERSTAND WHO WE ARE AND WHAT WE DO. I TOOK THIS PHOTOBECAUSE I WAS WALKING AROUND CAMPUS AND I THOUGHT, OKAY, NOW WE PUT IT ON THE SIDES OF SEMIS AND TRAILERS SO NOW I'VE ARRIVED. THEY'RE ACTUALLY USING IT BUT IT DOES AGAIN HELP MAKE THE CONNECTION FOR PEOPLE. NOW CONTRARY TO WHAT CONGRESSMAN SIMPSON SAID, WE ARE IN THE NEWS EVERY DAY, WE MAY NOT BE NIH IN THE NEWS, IT MAY BE AN INSTITUTE OR CENTER OR OFFICES OR IT MIGHT BE JOHNS HOPKINS OR MAYO OR ONE OF THE GRANTEE IRNS IRNS--INSTITUTIONS AND NOT ALWAYS DO YOU SEE A CONNECTION BACK TO NIH. IN FACT THAT'S SOMETHING WE TRIED TO ENCOURAGE, WE HAVE A WHOLE PIO NETWORK, WE WORK WITH GRANTEE INSTITUTIONS AND ONE OF THE THINGS WE ASK THEM TO DO IS TO MAKE SURE THEY ALWAYS MAKE A CONNECTION IN THE PRESS RELEASES THAT THE FUNDING IS MADE POSSIBLE BY A GRANT FROM NIH JUST SO PEOPLE AGAIN CAN MAKE THE CONNECTIONS. BUT WE ARE DEFINITELY IN MAIN STREAM NEWS EVERY DAY, SOCIAL MEDIA, I MEAN IT'S PRETTY HARD TO MISS NIH. DR. CLAYTON HAS DONE HER FAIR SHARE OF GETTING US OUT IN THE NEWS ESPECIALLY IN SEX AS A BI ONOLOGICAL VARIABLE AND WOMEN IN CLINICAL TRIALS AND OTHER ISSUES. DARE I SAY HOW WONDERFUL SHE IS AT MEDIA RELATIONS AND I DON'T THINK SHE REALIZES HOW GOOD SHE IS AT THIS. SO SHE HAS REALLY MADE HER MARK HERE AND FOR WOMAN'S HEALTH AS WELL AND IS OUT THERE ALL THE TIME. A FEW YEARS BACK, SHE AND DR. COLLINS AS YOU PROBABLY ARE AWARE PUBLISHED THE COMMENT IN NATURE ON SEX AND GENDER AND STUDIES. OKAY, DR. COLLINS, MY SECOND PART AS I SAID, THIS WOULD BE HOW HE TAPS INTO COMMUNICATIONS OR APPROACHES COMMUNICATIONS ALL WITH THE GOAL OF TELLING OUR STORY, OF MAKING THE CASE. NOW YOU MAY SEE THE PIN ON HIS LAPEL, IN FACT, I HAVE RUN OUT OF THEM, I WAS GOING TO BRING--SO WHEN I GET A NEW BATCH, ALTHOUGH THEY'RE NOT MADE WITH APPROPRIATED DOLLARS, THEY'RE MADE BY US, AN OUTSIDE ORGANIZATION, I DID COME UP WITH THE IDEA BECAUSE IT'S A PICK, IT'S I GUITAR PICK AND FRANCIS PLAYS THE GUITAR SO IT SEEMED LIKE IT MADE A CONNECTION, WE MADE THEM WITH GUITAR PICKS AND BACKINGS THE DAY THE GOVERNMENT SHUT DOWN ON OCTOBER 1, 2013, NOT THAT I REMEMBER THAT DAY BUT WE GLUED THEM TOGETHER AND BROUGHT THEM TO AN EVENT THAT EVENING AND PASSED THEM OUT AND THEY PROMPTLY FELL APART AS SOON AS PEOPLE TRIED TO PUT THEM ON, SO THAT DIDN'T WORK OUT SO WELL, SO AN OUTSIDE GROUP TOOK PITY ON US AND ACTUALLY MADE THEM AND HE HANDS THEM OUT WHEN HE GOES TO SEE MEMBERS OF CONGRESS, WHEN HE GOES TO SEE OTHER FOLKS AND IT SAYS: HOPE AT NIH. IT'S JUST KIND OF A THING WE'VE USED SINCE THEN. SO I'M GOING TO GO OVER MEDIA INTERVIEWS, SOCIAL MEDIA, HIS VISITS, EVERYTHING, YOU MIGHT THINK, HOW DOES IT--WHAT'S THAT THE GO TO DO WITH MAKING A CASE FOR NIH. BUT ALL THESE AREAS IS OUR WAY OF TRYING TO GET OUT THERE. SO HE'S GIVING A FEW PRESENTATIONS, ALMOST A THOUSAND AND LAST YEAR OVER A HELPED ALONE WILL BE PARTICIPATING. HE'S GIVEN TALK AFTER TALK BUT THE NEXT ONE COMING UP AT THE END OF APRIL. APRIL AT THE MILKEN GLOBAL CONFERENCE. HE'S ALSO NOT BEEN SHY ABOUT GETTING OUT IN THE PRESS. SO WHEN SEQUESTRATION HAPPENED, MARCH OF 2013, WE WERE TOLD STAY ON THE SIDELINES THIS IS NOT YOUR FIGHT. AND SO, FIRST INTERVIEW HE DID, HE JUST WAS VERY CANDID EXPW I WAS CALLED VERY QUICKLY ONCE THAT STORY CAME OUT. IT WAS REMINDED THAT YOU GUYS AREN'T DOING THAT AND SO THE NEXT TIME HE DID THE SAME THING AND THE SAME THING AND THE SAME THING AND OVER AND OVER AND OVER BUT IF FAIRNESS TO ME, I DID SEND TALKING POINTS AHEAD OF TIME. [LAUGHTER] SO TO A POINT WHERE THE GUY--I THINK OTHERS GOT COMFORTABLE WITH IT AND I WOULD SAY WITH SEQUESTRATION, NIH WAS ONE OF THE FEW AGENCIES TALKING ABOUT IT CONSISTENTLY TALKING ABOUT THE IMPACT OF SEQUESTRATION ON GRANTS ON RESEARCH AND ULTIMATELY PEOPLE'S LIVINGS. SO AGAIN,--PEOPLE'S LIVES. SO AGAIN HE DID THIS IN THE FALL, WAS TALKING ABOUT THE SHUT DOWN HE GOT OUT THERE AND IN THE 18 DAYS OF THE SHUT DOWN WE RAN 9000 STORIES. SO HE REALLY TRIED TO EXPLAIN THAT WHEN YOU SHUT THE GOVERNMENT DOWN, THERE'S A DEFINITE IMPACT AND FOR EXAMPLE, HERE'S THE IMPACT IT HAS ON NIH ON CAMPUS AWELL--AS WELL AS AROUND THE COUNTRY. WE TRY TO GET HIM OUT AT ALL KINDS OF PROGRAMS. I WAS AT A MEETING AND SOMEBODY FROM AN OUTSIDE INSTITUTION, SAID I REALLY NOTICE THAD NIH IS TRYING TO GET INTO OTHER VENUES OF MEDIA AND I APPRECIATED THAT BECAUSE YES, WE ARE TRYING TO DO THAT. THEY DID A POWER PLAYER OF THE WEEK ON FOX NEWS SUNDAY FOR HIM A COUPLE YEARS AGO. HE WAS ON THE COBERT REPORT, GOT HIM ON A NUMBER OF TIMES AND PEOPLE THOUGHT I WAS CRAZY TO BOOK HIM ON COBERT BECAUSE IT WAS KIND OF A WILD AND CRAZY SHOW AND YOU NEVER QUITE KNEW WHAT WAS HAPPENING BUT STEPHEN COBERT LIKED FRANCIS A LOT AND ALWAYS MADE SURE THE SHOWS WENT VERY WELL AND 2012 AS A RUN UP TO THE HBO SPECIAL WE DID ON OBESITY IN AMERICA, FRANCIS WENT ON THE SHOW WITH A 5-POUND SLAB OF FAT. THAT'S WHAT THAT WAS. IT'S PLASTIC BUT IT LOOKS AND FEELS LIKE THAT. FOR THE BRAIN INITIATIVE, HE WENT BACK ON AND STEPHEN WORE A BRAIN CAP AND WE PRETENDED THOSE WERE HIS BRAIN WAVES AND THEN HE ACTUALLY PARTICIPATED IN THE LAST SHOW. SO IT WAS FUN. JUST SOME MORE EXAMPLES, BEING ON WAIT WAIT, DON'T TELL ME, THE NPR SHOW ON SATURDAY MORNINGS, CHARLIE ROSE, SO WE TRIED TO--HE'S GAME FOR JUST ABOUT EVERYTHING, INCLUDING SINGING THE NATIONAL ANTHEM AT THE NATIONALS PARK WHICH HE DID LAST MAY. AND SO, NOT EVERYBODY WOULD TAKE ON THAT CHALLENGE. HE CAN SING, TO BOOT. YES! YES! AND PUN INTENDED HE KNOCKED IT OUT OF THE PARK. HE REALLY DID A GREAT JOB. AGAIN, IT'S ALL PART OF MAKING SURE NIH IS IN VARIOUS PLACES. LAST FALL, HE DID A SPACE CHAT ON FACEBOOK LIVE WITH DR. RUBINS, WHO WAS ON THE SPACEITATION AND THAT WAS FUN AND I'M--SPACE STATION AND THAT WAS FUN. I AM ALWAYS QUESTIONING THE NUMBERS YOU HEAR ON FACEBOOK AND TWITTER, THIS ONE WAS DEFINITELY LIKE 80 KABILLION VIEWERS. BUT I BELIEVE IT. WE GOT NUMBERS FROM A LOT OF DIFFERENT AREAS AND IT WAS ALL VERY, VERY POPULAR. BUT AGAIN, ALWAYS TRYING NEW WAYS TO REACH THE PUBLIC. OUR VISITORS, WE'VE A RANGE OF VISITORS OVER THE YEARS. AND I MENTIONED THE DALAI LAMA. I WILL JUST SAY WHAT HAPPENED THAT DAY IF YOU ARE WONDERING. SO THAT DAY I WAS ARRANGING THOSE CHAIRS TO MAKE SURE EVERYBODY WAS GOING TO BE SET.% I GOT A CALL FROM HIS ADVANCE MAN WHO TOLD ME, THAT I HAVE 700 TIARAS BET ANS COMING TO THE NIH CAMPUS TO MEET WITH HIS HOLINESS AN HOUR BEFORE HE MEETS WITH OUR THOUSAND NIHERS. SO THAT WAS MY CHALLENGE TO MAKE THAT HAPPEN. AND I HAD THEM ALL COME INTO THE AUDITORIUM AND HE MET WITH THEM AND THEN THEY ALL WENT OUT THE NORTH AND ALL THE NIHERS CAME IN THROUGH THE SOUTH ENTRANCE AND I THINK MOST PEOPLE WERE JUST--FELT LIKE IT WAS A DELAY, THEY JUST DIDN'T KNOW WHY EXACTLY BUT WHAT WAS ONE OF MY MORE MEMORABLE DAYS. JUST AN EXAMPLE OF SOME OF THE INITIATIVES THAT WE HAVE GOING ON PRECISION MEDICINE GOING ON WHICH IS NOW CALLED THE ALL OF US RESEARCH PROGRAM, DARREL RICHARDSON HERON HAS BEEN NAMED LAST WEEK AS THE CHIEF ENGAGEMENT OFFICER, SHE'S JOINED US AND LUCKILY WE WERE ABLE TO HIRE HER BEFORE THIS CURRENT HIRING FREEZE. ERIC DISHMAN IS--HE IS AN UNCONVENTIONAL HIRE, HE CAME FROM INTEL. HE'S NOT AN M. D. OR Ph.D., BUT HE'S A SOCIAL SCIENTIST BY BACKGROUND AND CANCER SURVIVOR AND VERY DEDICATED AND COMMITTED TO LAUNCHING THE MILLIO PERSON COHORT PLATFORM. WE HOPE TO LAUNCH IT PERHAPS SOMETIME IN THE FALL, BUT THEY JUST WANT TO MAKE SURE EVERYTHING IS READY. WE DON'T WANT TO HAVE A WEB SITE GO OUT AHEAD OF ITSELF TIME AS CAN YOU UNDERSTAND THAT. OKAY, NOW, JUST TO TALK ABOUT SOME OF THE PRODUCTS THAT WE HAVE, THIS IS A CONSUMER, I'D CALL IT A CONSUMER NEWS LETTER THAT PULLS FROM NIH RESEARCH RESULTS AND DR. HARRISON WINE PUTS IT TOGETHER WITH THE STAFF IN OUR OFFICE AND IT'S AVAILABLE IN PRINT AND ONLINE AS WELL. HE ALSO DOES RESEARCH MATTERS WHICH IS--I CALL IT A WEEKLY BLOG AGAIN OF CURRENT RESEARCH AS BECOMING MORE AND MORE POPULAR. ALTHOUGH THIS IS OUR NEWS LETTER, YOU MAY BE INTERESTED IN LOOKING AT THIS ON OUR WEB SITE WE DO HAND OUT PRINT COPY BUT IT'S AVAILABLE ONLINE AND YOU GET A GOOD SENSE OF WHAT'S HAPPENING AROUND THE CAMPUS AND AT NIH. WE HAVE A NEW WEB SITE, SPANISH LANGUAGE WEB SITE THAT WE JUST LAUNCHED THAT I JUST WANT TO MAKE YOU AWARE OF. ALSO I WANT TO POINT OUT AS I UNDERSTAND IT, THE SEARCH FOR WOMEN'S HELP IS TAKING OVER THE WOMEN'S SCIENCE AND WIKIPEDIA PAGE. DIDN'T KNOW IF YOU KNEW THAT. >> OKAY. >> SO THAT'S THE HIGHLIGHT, WOMEN IN SCIENCE. WE HAD A WIKI-THON, BUT NOW IT'S UPDATED AND TO SHOWCASE AND HIGHLIGHT WOMEN AND SCIENCE. WE HAVE AN IMAGE GALLERY THAT IS BRAND NEW AND EASIER TO USE AND NAVIGATE THAN BEFORE. WE HAVE 10-12,000 VIEWS ON THIS A DAY. SO IF YOU ARE LOOKING FOR A PHOTOFROM NIH OR A SCIENTIFIC ONE, THAT'S SOMETHING TO KEEP IN MIND. OUR ONLINE BRANCH MANAGES THE NIH WEB SITE AND YOU HAVE QUITE A FEW PEOPLE TAPPING INTO THE WEB SITE FOR HEALTH INFORMATION OR GRANT AWARD INFORMATION AS WELL AS SOCIAL MEDIA CHANNELS, WE DO EVERYTHING FROM TWITTER, FACEBOOK, AND SO VERY ACTIVE IN THAT REGARD. I PUT THIS UP BECAUSE THIS IS KIND OF A DAY THAT I'LL REMEMBER BUT IT ALSO REFLECTS HOW WE'RE TRYING TO TELL OUR STORY AND BE IN THE MEDIA. WE HAD A PRESS CONFERENCE ON THE NORTHSIDE OF THE CLINICAL CENTER-- >> RECORDING: PLEASE PARDON THE INTERRUPTION YOUR CONFERENCE CONTAINS LESS THAN THREE PARTICIPANTS AT THIS TIME. IF YOU WOULD LIKE TO CONTINUE, PRESS STAR ONE NOW OR THE CONFERENCE WILL BE TERMINATED. >> --SORRY ABOUT THAT THAT'S NINA PHA MR AFTER BEING TREATED FOR EBOLA AND DR. FAUCI, WANTED TO MAKE SURE EVERYONE SAW SHE WAS NOT INFECTIOUS AND THAT'S DR. COLLINS IN THE FOREGROUND. THERE ARE ABOUT 15 SILENT TRUCKS OUT THERE AND IT WAS A MAJOR MAJOR STORY. ANOTHER THING THAT'S--I WANTED TO MENTION IS THE DISCOVERY CHANNEL WAS EMBEDDED IN THE CLINICAL CENTER FOR MORE THAN A YEAR FOLLOWING PATIENTS AND THEIR FAMILIES AND THEY FOLLOWED FOUR PATIENTS AND THEIR FAMILIES AND THEY DON'T HAVE AN EXACT TIME IN AUGUST BUT IT WILL AIR IN AUGUST. SO IT'S THREE PART, THREE-TWO HOUR SEGMENTS. A TOTAL OF SIX HOURS AND IT ALL TAKES PLACE OVER HERE IN THE CLINICAL RESEARCH. IT'S A FIRST OF ITS KIND TO HAVE THIS DEGREE OF GROUP EMBEDDED, I KNOW HOPKINS HAS DONE IT IN THE PAST BUT I DON'T THINK ANYBODY SPENT MORE THAN A YEAR DOING THAT SO IT'S A VERY POWERFUL AND IT'S REALLY SHOWS THE BRAVERY OF PATIENTS AND THEIR FAMILIES AND THE COMMITMENT OF THE HEALTHCARE PROFESSIONALS. I ALSO COULDN'T LEAVE WITHOUT HIGHLIGHTING AGAIN DR. CLAYTON, WE PUT ALL THIS IN THE NIH RECORD, THE NATHAN DAVIS AWARD AND THE RED DRESS AWARD BUT AGAIN SHE HAS BEEN AN IMPORTANT PART OF TELLING THE NIH STORY AND GOING OUT TO REPORTERS. IT TAKES A RISK. IT TAKES A LOT OF GUTS TO GET OUT THERE, I HAVE AN ONCAMP RAINTERVIEW, I DON'T DO THEM. I BOOK THEM FOR OTHER PEOPLE AND IT DROVE HOME THE FACT THAT YEAH, THIS ISN'T EASY SO I APPRECIATE WHAT JANINE HAS DONE AND DR. COLLYNNS AND OTHERS HAVE GONE OUT THERE AND TOLD--MADE THE CASE FOR NIH RESEARCH. SO WITH THAT I WILL BE HAPPY TO TAKE QUESTIONS. YES? [APPLAUSE ] >> THANK YOU SO MUCH JOHN, I WILL START WITH JUGEY REAGAN STIENER. >> SO I THOUGHT YOU DID EXCELLENT WITH MAKING DR. COLLINS THE FACE OF NIH, IT'S AMAZING BUT WHAT YOU SAID ABOUT THE MONEY OF NIH GOES OUT ALL OVER THE COUNTRY RESONATED WITH ME AND I WONDERED IS THERE A WAY YOU CAN DO A CAMPAIGN LINKING SCIENTISTS TO THEIR FINDINGS AND SHOWING A PICTURE. I THINK HUMANIZING SCIENTIST SYSTEM ONE THENG I WORK WITH A COMMUNITY ADVISORY BOARD AND THEY DIDN'T KNOW MUCH ABOUT SCIENTISTS. PEOPLE THINK WE'RE ODD PAULS THAT SIT IN A LAB WITH A PIPETTE AND SOME OF US MIGHT BE THAT AND SOME OF US MIGHT NOT. BUT IF YOU COULD LINK SCIENTISTS WITH THE SENIOR PEOPLE AND JUNIOR PEOPLE AND DISCOVERED A CURE OR TREATMENT FOR DIABETES, THAT MIGHT SOLIDIFY IT. YOU KNOW COLORADO DID THIS. BALTIMORE DID THIS. AND. >> THAT'S A GREAT IDEA. IT COULD BE AN EXPANSION, WE'VE DONE A TWITTER CAMPAIGN OVER THE LAST SEVERAL YEARS OF NIH IN YOUR STATE, TO SHOW THE AMOUNT OF FUND THAG HAS GONE TO A STATE BUT YOU COULD EXPAND ON THAT AND TELL THE STORIES OF SCIENTIST AND THEIR RESEARCH AND DISCOVERIES. BECAUSE THIS IS AN AREA WHERE EVERYBODY TAKES IT FOR GRANTED THAT THEY GO TO A DOCTOR AND THERE'S SOMETHING THERE FOR THEM AND THEY DON'T REALLY KNOW WHERE IT CAME FROM, HOW CAN CAME ABOUT AND WHO OR WHAT SUPPORTED IT AND MADE IT POSSIBLE. SO I THINKOOSE--I THINK IT'S A GREAT IDEA. WE COULD OFFER IT TO THE P. I. O. NOT WORK BECAUSE WE'RE COUNTING ON THE OFFICERS AND GRANTEE INSTITUTIONS TO DO A LOT OF THIS LOCALLY. >> [INDISCERNIBLE]. >> YEAH. WE DID--IT'S NOT QUITE THE SAME BUT LAB TV, WE DID GOSH ABOUT A THOUSAND VIDEOTAPEED OF YOUNG SCIENTISTS PRIMARILY IN LABS ACROSS THE COUNTRY. AND IT'S UP THERE BUT THE OTHER POINT ABOUT COMMUNICATIONS, IT'S NOT A DO IT AND YOU'RE DONE, YOU JUST HAVE TO ALWAYS DO IT, YOU KNOW CONSTANTLY BE VIGILANT ABOUT IT AND ALSO TELL A STORY, MAYBE A LITTLE DIFFERENT WAYS OR IN A DIFFERENT FORMAT, SO I THINK THAT'S A GREAT IDEA. THANKS. >> THERESA AND THEN CARMEN AND THEN JILL. >> THANK YOU SO MUCH FOR WHAT% YOU DO. EXCELLENT TALK. I IN MY CAPACITY ASANCE INSTITUTE OF NORTHWESTERN WOMEN GO AROUND ILLINOIS AS PART OF OUR WOMEN ILLINOIS REGISTRY. SO IN ONE OF THE COUNTRIES, I WAS TALKING ABOUT BASIC SCIENCE AND TRANSLATIONAL SCIENCE AND MEDICINE AND THIS WOMAN SAID I DON'T WANT YOU TO DO THE SIMPLE STUFF, I WANT YOU TO DO THE HARD STUFF AND WHEN WE TALK TO CONGRESS, THEY UNDERSTAND A LITTLE BIT MORE THAN RPGHTS BUT, I THINK WE'RE DOING OURSELVES A DISSERVICE BY SAYING BASIC TRANSLATIONAL CLINICAL. IN FACT, ONE OF THEM SAID, I'M TRYING TO REMEMBER,--IT WAS--THERE ARE ONLY TWO KINDS OF SCIENCE, GOOD SCIENCE AND BAD SCIENCE SO THERE'S NOT BASIC TRANSLATION ON CLINICAL MEDICINE. SO IT SEEMS LIKE WE SOMEWHAT TALK TO OURSELVES WHEN WE'RE WITHIN ACADEMIC CENTERS AND EVEN WITHIN THE GEOGRAPHY OF ACADEMIC CENTERS SO IN CHICAGO. , SO WITHIN OUR AREAS WHERE ACADEMIC CENTERS ARE BUT IF WE GET OUT INTO THE COUNTRY, JUST YAWNTD COOK COUNTY. --BEYOND COOK COUNTY, BASIC MEANS BASIC. BASIC MEANS EASY. YOU'RE DOING THE EASY STUFF. YOU'RE NOT DOING THE HARD STUFF, YOU'RE DOING STUFF THAT'S SIMPLE AND I THINK WE HAVE FORGOTTEN HOW TO COMMUNICATE WITH COMMON LANGUAGE AND WE GET SO USED TO HEARING OURSELVES THAT WE KEEP SAYING OH, BASIC SCIENCE AND I CATCH MYSELF SAYING SOMETIMES FUNDAMENTAL SCIENCE AND BASIC SCIENCE AND I TRY TO KEEP THAT OUT OF MY VOCABULARY BECAUSE WE'RE DOING SCIENCE, SCIENCE TO MEDICINE. >> YEAH. >> AND I WOULD URGE NIH FRONT DOOR TO REALLY BE THAT AND I KNOW SOME OF THIS PARSING CAME ABOUT WHEN WE REALLY WANTED TO GET TRANSLATION IN THERE BECAUSE THERES A GROUP THAT REALLY THOUGHT THAT THEY WERE BEING UNDERREPRESENTED BUT AS A CONSEQUENCE OF US DOING THAT AND THE ENDOCRINE SOCIETY DOES IT TOO WHERE WE HAVE THE TRI PARTIDE MISSION BUT WE PAINT OURSELVES IN A VERY DIFFICULT CORNER WHEN WE USE LANGUAGE THAT 95% OF THE POPULATION THINKS, YOU KNOW POORLY OF WHAT WE DO AND I THINK THAT NUMBER'S ACTUALLY RIGHT. IT'S A LARGE DISPROPORTIONATE NUMBER OF PEOPLE WHO DON'T KNOW ANYTHING ABOUT THE ACADEMY AND THEN THEIR ATTITUDES OF SET AND THEN POLITICALLY THEY THINK THAT WAY. YOU KNOW THERE'S JUST A--WE'RE OUR OWN WORST ENEMY UNLESS WE THINK ABOUT HOW TO DESCRIBE WHAT WE DO BETTER. SO I LIKE TO SAY SCIENCE AND MEDICINE. >> THAT A--THAT'S GOOD. BECAUSE A LOT OF DELINEATION IS WE HAVE DIFFERENT AUDIENCES. >> BUT OUTWARDLY-- >> PEOPLE FEEL LIKE DR. COLLINS IS TOO FOCUSED ON CLINICAL, SO WE HAVE MAKE A POINT OF TALKING ABOUT BASIC. >> BUT SCIENCE AND MEDICINE. >> CERTAIN GROUP-- >> PEOPLE DON'T KNOW WHAT YOU'RE TALKING ABOUT. >> YEAH, SCIENCE AND MEDICINE. SCIENCE AND MEDICINE. YEAH. >> DR. GREEN? >> SO VERY--SO AN ENTERTAINING TALK, I GUESS THE ONE THING I WOULD SAY AND I DON'T WANT TO BELABOR THIS POINT IS THAT I THINK PEOPLE ARE CONFUSED. SO TO THE EXTENT YOU CAN BE LITERACY COMMUNITY AND I THINK THERE'S--I CAN'T REMEMBER WHO THAT IS IN WOMEN'S HEALTH BUT I THINK THAT WOULD BE REALLY PARTICULARLY IMPORTANT. YOU KNOW IT BOTHERS ME WHEN PEOPLE DON'T UNDERSTAND THE DIFFERENCE BETWEEN DATA OR FACTS OR WHAT IT TAKES TO GET TO THE TRUTH AND I THINK THAT'S PART OF THE CONVERSATION THAT WE'VE HAD. SO WE'VE HAD THREE EXCELLENT PRESENTATIONS. PEOPLE TALKED ABOUT SCIENTIFIC RIGOR. BUT IF WE CAN DUM IT DOWN TO MY GRANDFATHER WHO IS 94 BUT ACTUALLY PRETTY SMART GUY, I THINK THAT'S IMPORTANT. AND I THINK THAT THAT WOULD HELP US ONE TO COMMUNITYICATE THE IMPORTANCE OF THE WORK THAT WE'RE DOING NOT JUST HERE BUT IN INSTITUTIONS FAR AWAY. SO, THAT'S MY MAJOR COMMENT. IF YOU COULD PARTNER WITH THE HEALTH LITERACY COMMUNITY TO SORT OF THINK ABOUT HOW--YOU KNOW MAYBE AS SIMPLE AS PUTTING UP A WEB SITE BUT THEN WE HAVE TO THINK ABOUT WHO DOESN'T USE WEB SITES. HOW DO WE GET THESE MESSAGES ACROSS. >> THANK YOU VERY MUCH, EXCELLENT POINT. WE HAVE MADE A FORAY INTO IT AND HEALTH LITERACY, YOU HAVE HEARD HOW LONG I'VE BEEN HERE. IT'S JUST KIND OF COMES AND GOES. 25 YEARS AGO, I FELT LIKE THERE WAS A REAL MOMENTUM IN THAT AND WE HAD INFORMATION AND THEN IT KIND OF SUBSIDED AND NOW, I FEEL LIKE IT'S COMING BACK AGAIN BUT THERE NEEDS TO BE SO MUCH MORE. >> I WOULD DISAGREE. I HAVE CERTAIN--MAYBE COMING UP FOR CERTAIN POPULATIONS, THE PART OF THE REASON WHY I BELIEVE WITHOUT DATA, BUT LOTS OF EXPERIENCE IS, THAT WE'VE NOT BEEN ABLE TO COMMUNICATE OUR MESSAGE WELL WHICH GOES BACK TO MY COLLEAGUE TERESA'S POINT. SO I'M NOT SHURN WE'VE EVER HAD HEALTH LITERACY. I AM A PHYSICIAN AND IF I GO FOR A CERTAIN PROCEDURE, I'M NOT LITERATE ABOUT THAT, I MAY HAVE MORE KNOWLEDGE THAN SOMEBODY ELSE. SO I THINK IT'S A WHOLE SPECTRUM OF THINGS. >> THANK YOU. >> AND I JUST HAD ANOTHER--SIMPLE COMMENT, WELL IT'S NOT THAT SIMPLE ABOUT THE FACT THAT WE NEED TO EDUCATE PEOPLE ABOUT WHAT THE MONEY IS GOING FOR IN SCIENCE AND I READ AN ARTICLE IN THE NEW YORK TIME THIS IS MORNING THAT SAID THAT PART OF THE REASON THE TRUMP ADMINISTRATION--I DON'T KNOW IF I CAN SAY THIS HERE, DECREASED THE BUDGET IS THEY DIDN'T UNDERSTAND INDIRECT COSTS AND THOUGHT THEY COULD BASICALLY DECREASE INDIRECT COSTS NOT REALIZING THAT YOU CAN'T DO THE SCIENCE WITHOUT HAVING THE BUILDING AND THE SUPPLIES AND THE INFRASTRUCTURE TO TO THE ENTIRE COST OF RUNNING EXPERIMENTS IN THE EXTRA MURAL PROGRAM BUT I THINK IT WOULD BE WORTH TRYING TO DO THAT. >> ROBERT PAIR'S ARTICLE IN THE PAPER THIS MORNING. YEAH, I AGREE. AND EVEN THE TERM INDIRECT COST IS NOT MEANINGFUL TO MOST PEOPLE IF ANYBODY. YEAH. >> SO WE'RE GOING TO NEED TO WRAP UP AND GO TO THE NEXT THING--THANK YOU AGAIN, JOHN. REALLY APPRECIATE THAT. >> [ APPLAUSE ] >> THANKS FOR HAVING ME. >> ALWAYS TRIEFING FOR PLAIN LANGUAGE. >> NEXT WE HAVE THE DOCTOR FROM ORWH,. >> GOOD MORNING IT GIVES ME IMMENSE PLEASURE DR. NEILL EPPERSON HE HAS HAD A TREMENDOUSLY END PROGRAM OVER THE LAST FIVE YEARS ESPECIALLY IN THE AREAS OF BEHAVIORIAL HEALTH AND MOLECULAR MODELS OF STRESS AND ENDOCRINOLOGY AND NEUROIMAGING. DR. EPPERSON HAS OVER 30 YEARS OF WORK. I WANT TO HIGHLIGHT A RECENT PUBLICATION WHERE SHE AND HER COLLEAGUES SHOWED TRAUMA AND STRESS INCREASES RISKER OF RISK OF DEPRESSION DURING MENOPAUSE. SO ON BEHALF OF ALL THE NIH I WELCOME DR. EPPERSON, AND DISCUSSING NOT SO LOST IN TRANSLATION, WHICH WE WERE JUST TALKING ABOUT, EXAMPLES OF BENCH TO BEDSIDE TO COMMUNITY HEALTH RESEARCH. THANK YOU DR. EPPERSON. >> WELL, IT'S A LITTLE DAUNTING TO COME AND SPEAK RIGHT AFTER THE DIRECTOR OF COMMUNICATIONS. BECAUSE I HAVE TO BE VERY CLEAR IN COMMUNICATING WITH ALL OF YOU HOW EXCITED I AM TO BE HERE TODAY. IT'S SUCH AS HONOR TO BE ABLE TO COME AND TALK TO YOU ABOUT THE WORK WE'VE BEEN DOING AT UNIVERSITY OF PENNSYLVANIA FOCUSING ON WOMEN'S HEALTH RESEARCH AS WELL AS SEX AND GENDER, ISSUES, PARTICULARLY WITH RESPECT TO BEHAVIORIAL HEALTH BUT AS MUCH OF AN HONOR AS IT IS, IT'S ALSO HUMBLING. IT'S AMAZING TO BE HERE WITH SO MANY ESTEEMED COLLEAGUES THAT HAVE COME BEFORE ME THAT HAVE DONE THE RESEARCH AND I JUST WANT TO MAKE A SPECIAL CALL OUT TO CAROL IN MISSOURI WHO SERVED AS A ROLE MODEL FOR ME AT YALE WHEN HE DEVELOPED WOMEN'S HEALTH RESEARCH AT YALE BECAUSE WHEN I WEENK TO PE, N, THAT'S WHAT I WANTED TO DO. SHE SHOWED ME HOW IT WAS DONE AND HOW IT WAS DONE SUCCESSFULLY AND SO I AM VERY GRATEFUL. SO THANK YOU. SO YEAH, SO WE WILL TALK ABOUT NOT SO LOST IN TRANSLATION. EXAMPLES OF BENCH TO BEDSIDE TO COMMUNITY RESEARCH HIGHLIGHTING AND USING THIS TOPIC TO HIGHLIGHT JUST HOW WERE THE THE PROGRAMS HAVE BEEN TO THE UNIVERSITY OF PENNSYLVANIA. SO TO GET STARTED I WANT TO TALK ABOUT OUR MISSION STATEMENT. WE'VE HAD A COUPLE OF THOSE TODAY AND WE WILL TALK ABOUT THE DEVELOPMENT OF THE WHOLE SCHOOL INITIATIVE. EXAMPLES OF HOW SORT OF MULTICYCLE, MULTIPI AND PROGRAM GRANTS LIKE THOSE THAT HER WITH P50S AND 30S AS WELL AS K12S CAN BE USED TO PROMOTE TRANSLATIONAL RESEARCH AT AN INSTITUTION, NOT JUST WITHIN A GROUP BUT WITHIN AN ENTIRE EN--STRATEGIES TUITION AND THEN I WANT US TO HAVE A FEW MINUTES TO THINK ABOUT BROAD STROKES. SO OUR MISSION STATEMENT, AND I PROMISE YOU, I DID NOT CHANGE THE SLIDE BASED UPON THE TALK THIS MORNING ABOUT THE ALL HEALTH OR THE HEALTH FOR ALL. --ALL OF US. YES. SO OURS IS AN ALL-HEALTH MIGDZ STATEMENT AS WELL BECAUSE BASICALLY OUR GOAL IS TO ADVANCE HEALTH FOR ALL BY CONSIDERING THE ROLE OF SEX AND GENDER AND ALL HEALTH RELATED RESEARCH. SO BENCH TO BEDSIDE TO COMMUNITY AND BACK. WHEN I MEAN HEALTHCARE FOR ALL, I AM NOT JUST THINKING ABOUT WOMEN'S HEALTH, BUT MY WORK STARTED IN WOMEN'S HEALTH BUT THEN MOVED INTO SEX AND GENDER BECAUSE I SAW IT WOULD BENEFIT ALL PEOPLE. AND THERE ARE ALSO GENDER AND SEX MINORITIES THAT GET LEFT OUT OF THE DISCUSSION WHEN WE TALK ABOUT WOMEN OR SEX AND GENDER DIFFERENCES SO IT'S IMPORTANT TO THINK ABOUT ALL POPULATIONS SO THINKING ABOUT TRANSLATIONAL RESEARCH, OFTEN, YOU KNOW I STARTED MY WORK FOCUSING--OOPS THAT WAS REALLY--OOH, THESE ARE AUTOMATIC, WOW! I DIDN'T REALIZE THAT WAS GOING TO HAPPEN, BUT THE BOTTOM LINE IS THE FIRST SLIDE WAS FOCUSING ON THE IDEA THAT YOU START WITH HUMAN SUBJECTS RESEARCH WHICH IS WHAT I DID, BUT THEN, COLLABORATING WITH MY COLLEAGUE TRACEY BABRUTUS AT PENN, AND THEN HOW CAN WE TAKE THE WORK IN ANIMAL MODELS TRANSLATE IT TO HUMANS AS WELL AS WORK IN HUMANS TO ANIMALS AND THEN HOW DOES THAT IMPACT THE COMMUNITY? HOW DO WE GET THAT INFORMATION OUT TO THE COMMUNITY? IN A WAY THAT IMPLEMENTS THE DAILY BASIS AT WE COLLECTED IN THE LABORATORY IN A SUCCESSFUL WAY IN THE COMMUNITY? UP AN OVERVIEW OF HOW WELL GIVE DEVELOPED THIS WHOLE SCHOOL INITIATIVE THAT IS MEANT TO PROMOTE CONSIDERATION OF SEX IN GENDER AS CRITICAL HEALTH IN GENDER ACROSS A CRITICAL LIFE SPAN. SO WE STARTED OUT WITH A TIMELINE WHERE WHEN I WENT TO PEN IN 2009, WE WERE RELATIVELY SMALL BASED ON SINGLE ROONES, K-AWARD, THAT KIND OF THING. GREW THE CLINICAL GROUP AND AGAIN WE START WIDE A TRI-PARTIDE MISSION, WE DO CLINICAL CARE, WE HAVE A CLINICAL PROGRAM, FULL SCALE WHERE WE SEE WOMEN ACROSS THE REPRODUCTIVE LIFE SPAN, AND WE HAVE EDUCATION PROGRAM AS WELL AS THE RESEARCH PROGRAMS THAT I'LL TALK ABOUT IN MORE DETAIL. BUT GROWING THE PROGRAM, OVER A COUPLE OF YEARS AND TRUTHFULLY IT WAS CONNECTING WITH ELEN FREEDOM AN, MARY SAMMEL, WHO HAD BEEN WORKING WITH OBGYN FOR SEVERAL YEARS AND TRACEY HF-AND IT SERVED TOGETHER FOR KNITTING US TOGETHER AS A TEAM AND I WILL SHOW YOU THE DATA SHE COLLECTED OVER 14 YEARS BUT BECAUSE SHE HAD A COHORT FUNDED BY THE NATIONAL INSTITUTE ON IMAGING AND WHEN WE GOT THE SCORE, WE UPON ABLE TO HELP REINVIGORATE THAT ONGOING COHORT THAT WE'VE NOW CONTINUED TO BE ABLE TO STUDY ADDING THIS FOCUS ON STRESS THAT WE DEVELOPED. AND THEN OF COURSE, IN 2016, 2015, WE PUT IN OUR BIRCH APPLICATION AND THANK GOODNESS WE WERE SUCCESSFUL AND WITH THE BIRCWH WE HAVE BEEN LOVED BY OUR INSTITUTION, PENN TREATED ME WELL AND TREATED THEM WELL BUT THERE'S NOTHING LIKE GETTING EXTERNAL VALIDATION FROM THE GOVERNMENT TO REALLY MAKE YOUR INSTITUTION SIT UP AND PAY ATTENTION TO YOU. SO WITH BIRCWH FUNDING AND ADDITION TO SCORE, WE WERE ABLE TO PROMOTE THIS INITIATIVE ON PENN PROMOTEDS RESEARCH ON SEX AND GENDER IN HEALTH AND THIS WAS ACROSS DIFFERENT ORGAN SYSTEMS, IN MALES AS WELL AS FEMALES AND IN MANY CASES A LOT OF THESE IN THE SEX DIFFERENCES IN THESE DISORDERS VARIES DEPENDING ON UPON THE AGE OF ORGANISM OR WHERE THE PEOPLE ARE LIVING, THEIR HEALTH STATUS AND SO, EVEN THOUGH WE WERE ALL BELIEVERS IN SEX DIFFERENCES AND HOW IMPORTANT THEY WERE. IT WAS NOT SO EASY TO GET OUR INSTITUTION TO BE A BELIEVER UNTIL WE GOT THE BIRCWH IN ADDITION TO THE SCORE, AND I WANT TO HIGHLIGHT HERE EVE HIGGINBOGHT AMILLIO WHO IS VICE DEAN FOR INCLUSION AND DIVERSITY, ANITA ALLEN WHO IS THE VICE PRO VOAOF THE FOR FAC ULGTY AND THEN DAWN BERNELE WHO IS RESEARCH AT PENN. THESE THREE LEADERS PUT MONEY WHERE THEIR MOUTH IS, THEY SUPPORTED OUR PROGRAM AND THE DEVELOPMENT OF THIS CROSS SCHOOL INITIATIVE AND WITH THEM WE HAVE SALARY SUPPORT, PILOT FUNDING SUPPORT, SUPPORT FOR MEETINGS AND OTHER ADMINISTRATIVE ACTIVITIES THAT QUITE FRANKLY YOU CAN'T PUT ON NIH GRANTS. AND SO THEY REALLY HAVE ENABLED US TO BE ABLE TO DO THIS BUT WE WOULD NOT HAVE BEEN ABLE TO WITHOUT ORWH SUPPORT. SO OBVIOUSLY WE HAVE THE RECK QUISITE WEB SITE BUT WHAT KIND OF IMPACT HAVE WE HAD IN THE PAST. YOU KNOW 18 MONTHS WE'VE BEEN ABLE TO DO A LARGE REVIEW OF ALL THE IRB PROTOCOLS THAT HAVE BEEN SUBMITTED THAT ARE FOCUSING ON CLINICAL RESEARCH AND WE WANTED TO SEE AT BASE LINE WHAT OUR INVESTIGATORS AT PEN THINKING, ABOUT SEX AS A BIOLOGICAL VARIABLE WHEN THEY DESIGN THEIR STUDY BECAUSE THAT REALLY IS THE POINT WHERE PEOPLE SHOULD BE THINKING ABOUT SABV AS WELL AS THE EFFECTS OF GENDER ON THEIR OUTCOMES OF INTEREST AND I WON'T GO INTO THE DETAILS OF THAT STUDY BUT LET'S SAY WE HAVE A LONG WAY TO G. SO THOSE DATA SHOULD BE COMING OUT HOPEFULLY IN BIOLOGY OF SEX DIFFERENCES, IT'S UNDER REVIEW. WE WILL SEE. WE ALSO TRAINED THE INVESTIGATIONAL REVIEW BOARD MEMBERS AND WE ASKED THEM AND TAUGHT THEM HOW TO CONSIDER SEX AS A BIOLOGICAL VARIABLE AS THEY'RE REVIEWING THE IRB PROTOCOLS. WE HAVE ALSO BEEN IN NEGOTIATION WITH OUR IRB TO ACTUALLY CHANGE THE LANGUAGE OF OUR TEMPLATE. BECAUSE THERE'S TEMPLATES THAT PEOPLE USE FOR DIFFERENT KINDS OF STUDIES THAT THEY WANT TO GET REVIEWED BY THE IRB, AND IF WE CAN MAKE A LANGUAGE CHANGE HERE IN THE VERY BEGINNING WHEN PEOPLE ARE DESIGNING THEIR STUDIES AND IN THE FIRST STAGE OF GOING ON IRB APPROVAL, WE BELIEVE THAT BY THE TIME THE INVESTIGATOR CONDUCTED THE STUDY, ANALYZED THE DATA AND IS READY FOR PUBLICATION OR ADDITIONAL FUNDING THAT IT'S CONSIDERING SABV OR GENDER OR BOTH AND THEY'RE OUTCOMES OF INTEREST WILL BE A NO BRAINER BECAUSE IT WILL ALREADY BE THERE. AND THEN WE A REQUEST FOR PROPOSALS WHERE WE RECEIVED 22 APPLICATIONS FROM ACROSS THE INSTITUTION FOR THESE $240,000 PILOT FUNDING PROJECTS TO FOCUS ON OR TO ADD A FOCUS ON SEX AND GENDER TO THEIR OWN AREAS OF RESEARCH AND WE THINK IT'S A GOOD WAY IT PULL YOUNG PEOPLE TOGETHER INTO THINKING ABOUT SABV AND THEIR RESEARCH MOVING FORWARD. SO MOVING ON TO EXAMPLES SO HOW HAVE THESE MULTIPI, MOWLTY CYCLE ORWH FUNDING BEEN ABLE TO PROMOTE TRANSLATIONAL RESEARCH AND I WANT TO GIVE YOU EXAMPLES OF THE WORK WE'VE BEEN DOING WITH THE SCORE AND BIRCH, AND NIDA, AND NCI AND NIMH FUNDING? SO THE PURPOSE OF THE SCORE WAS FOCUS ON THE EARLY LIFE STRESS OR CHILDHOOD ADVERSITY MORE GENERALLY, NOT JUST ABUSE AND NEGLECT BUT OCCURRING IN THE PERIPIEWBITTAL WINDOW AND DOES THE TIMING BEFORE A GIRL GETS HER FIRST PERIOD OR AFTER SO THAT WHEN SHE IS HAVING THIS ADVERSITY ONSET ARE THESE CRITICAL WINDOWS? ARE THEY SENSITIVE PERIODS THAT FOR WOMEN WE KNOW ARE GOING TO INCREASE THE RISK OF EFFECTIVE DISORDERS WHICH WE KNOW OCCUR MORE FREQUENTLY IN WOMEN BUT BECAUSE I'M ALSO INTERESTED IN AGING WE'VE BEEN FOCUSING ON COGNITION AS A POTENTIAL OUTCOME AS WELL AND WE DESIGNED IS ITS WHERE WE LOOK AT ADVERSITY AND PREGNANCY AND OUTCOME AND WELL AS MENOPAUSE AND COGNITION AND MOOD AND ALSO INTERGENERATIONAL TRANSMISSION OF STRESS. SO DOES MOM'S LIFE HISTORY IMPACT HER GUESTATION IN SUCH A WAY TO IMPACT THE BABY'S DEVELOPMENT AND PUT THAT BABY AT INCREASED RISK OR RESILIENCE FOR FUTURE STRESSORS. AND AGAIN WE'RE INTERESTED IN THESE CRITICAL WINDOWS ACROSS THE LIFE CYCLE SO IN CHILDHOOD WHEN HE'S ADVERSITIES MIGHT HAPPEN AND THEN AROUND THE TIME OF PUBERTY WHEN WE KNOW THAT AFFECTIVE DISORDERS OCCUR OR AND YOU SEE THE DIFFERENCES IN AFFECTIVE DISORDERS, WITH PREVALENCE AND GIRLS AND FEMALES HAVING INCREASED RISK OF DEPRESSION AND PTSD, AND OBVIOUSLY WE'RE INTERESTED IN HOW THESE IMPACT THE PREGNANCY AND THE PREGNANCY OUTCOME BECAUSE THERE'S BEEN DATA THAT EARLY LIFE STRESS AND STRESS DURING PREGNANCY CAN LEAD TO AN INCREASED RISK IN PRETERM BIRTH AND POOR PREGNANCY OUTCOMES SO WE'RE INTERESTED IN THIS PARTICULAR TRANSITION AS WELL AS TRANSITION TO MENOPAUSE AND SOME OF THE THINGS THESE DIFFERENT PERIODS OF THE LIFE CYCLE HAVE IN COMMON ARE DYNAMIC FLUCTUATIONS AND REPRODUCTIVE HORMONES. AND WE KNOW THAT REPRODUCTIVE HORR MONITORS OF VARYING STEROIDS INTERACT WITH THE PITUITARY ADRENAL GLANDS AND THE IMMUNE SYSTEM SO WE'RE THINK BEING THIS FROM MULTIPLE SYSTEMS POINTS OF VIEW AND THAT'S ONE OF THE REASONS WE'RE SO INTERESTED IN THESE DEVELOPMENTAL TRANSITIONS. SO HOW DO YOU MODEL STRESS ADVERSE CHILDHOOD IN AN ANIMAL MODEL. IT'S NOT EASY BECAUSE OBVIOUSLY HAVE A BREECH OF TRUST BETWEEN THE CHILD AND THE PRIMARY ADULT CAREGIVER. IF THERE'S MOLESTATION OR ABUSE, OR NEGLECT, AND IT'S A BIT HARD TO SORT OF MIMIC THAT, COMPLETELY IN AN ANIMAL MODEL BUT TRACE EXPE HER LAB USE A CHRONIC VARIABLE STRESS MODEL MAINLY BECAUSE IT'S DIFFERENT KINDS OF STRESSORS AND IT OCCURS OVER A PERIOD OF TIME AND THE VARIABILITY OF IT AT LEAST CAN REFLECT SOME OF THE ASPECTS OF ADVERSITY THAT WE WERE LOOKING AT IN CHILDREN. WE MEASURE ADVERSE CHILDHOOD EXPERIENCES IN SEVERAL--IN ONE PARTICULAR WAY BUT THERE ARE MANY WAYS TO ASSESS THIS. I MEAN YOU CAN DO A CHILD TRAUMA QUESTIONNAIRE WHERE YOU ASK ABOUT SPECIFIC KINDS OF TRAUMATIC EEIVETS BUT WE FOLK UTION ON ADVERSITY USE AVERAGE CHILDHOOD EXPERIENCES QUESTIONNAIRE, IT WAS DEVELOPED BY THE CDC, IN KAISER PERMANENT E WHERE THEY USE THIS IN 20,000 PATIENTS THAT WERE IN KAISER PERMANENT HEALTHCARE SYSTEM AND THERE'S A GREATER EFFECT OF CHILDHOOD ADVERSITY FOR A NUMBER OF ADULT OUTCOMES BUT NOT JUST BEHAVIORIAL BUT CARDIOVASCULAR DISEASE, LOSS OF FIRST PREGNANCY, IN I GRAINS, AUTOIMMUNE DISORDERS, METABOLIC SYNDROME AND AGAIN MANY, MANY OUTCOMES AND IT'S A 10 ITEM QUESTIONNAIRE SO IT'S RELATIVELY EASY TO COMPLETE AND I TELL YOU RIGHT NOW PEOPLE DON'T MIND COMPLETING IT IN THE WAITING AREA AND IT DOESN'T FEEL TOO INVASIVE AND DOESN'T REQUIRE A TRAINED EXPERT SO WE FELT LIKE IT HAD GENERALIZABILITY TO A LARGER POPULATION BUT THERE ARE THREE QUESTIONS OF ABOUT ABUSE, TWO ABOUT NEGLECT, ONE REGARDING SEPARATION OR DIVORCE AND THEN FOUR QUESTIONS REGARDING HOUSEHOLD DYSFUNCTION. AND WHY CONSIDERED OUR STRESS GROUP, MANY OF OUR STUDIES TO BE THOSE WOMEN WHO HAD AT LEAST TWO OF THESE ADVERSE CHILDHOOD EXPERIENCES. NOW HOW DO WE DECIDE WHETHER THIS IS A PREPIEWBITTAL OR POST PIEWBITTAL, JUST CALLING IT BACK AND FORTH OF PERIPIEWBITTAL BECAUSE THE RODENT MODEL IS HARD TO REALLY, REALLY NARROW DOWN WITH RESPECT TO HORMONES BUT WHEN IT COMES TO THE HUMAN MODEL WE ASK WOMEN WHO THEY HAD THEIR FIRST PERIOD, SO MENARCHE, IS THE FIRST PERIOD, WE SUBTRACT TWO YEARS BECAUSE THERE'S HORMONAL ATTRACTION GOING ON ALREADY, SO ANYTHING THAT HAD THE OCCURRENCE IN THIS WINDOW WAS CONSIDERED PREPIEWBITTAL AND ANYTHING AFTER THAT, POST PIEWBITTAL, YOU MAY SAY NEILL, THAT YOU'VE BEEN DOING ANGING RESEARCH, I DON'T REMEMBER WHEN THINGS HAPPEN TO ME, HOW WILL THESE WOMEN TELL US WITH ANY KIND OF CONSISTENCY WHETHER THESE THINGS CONSIDER PRE, POST, OR WHENEVER ACROSS THE FIRST 18 YEARS OF THEIR LIFE, THAT IF THEY'RE WRONG THEY'RE CONSISTENTLY WRONG. BECAUSE WHEN WE ASK THEM A ABOUT A YEAR APART TO GIVE US ANSWER TO THE SAME QUESTIONS OUR CAPPA VALUE FOR THE OVERALL SCALE WAS ABOUT .8 WHICH IS QUITE GOOD AND BELIEVE IT OR NOT, THE SAME WAS TRUE FOR THEIR AGE AT MEN ARCHY. SO THINKING FIRST AT OUR PREGNANCY STUDIES AND FETAL OUTCOMES. WE THINK THESE ARE A GREAT WAY TO THINK ABOUT THE INTERGENERATIONAL TRANSMISSION OF STRESSES TO LOOK IN THIS MODEL SO INITIALLY THE SCORE IS SUPPORTING US TO GET INFORMATION ABOUT ADVERSITY, CHILDHOOD ADVERSITY FROM 1500 PREGINNOCENT WOMEN, WE WILL LOOK AT THOSE. WE ARE ALMOST THERE, WE HAVE 1450 AND WE WILL BE ANALYZING THOSE DATA WITH RESPECT TO PRE-TERM BIRTH. ABOUT 150 OF THESE MOTHERS URNTD GO LONGITUDINAL ASSESSMENTS, LIKE SEVEN ASSESSMENTS THROUGHOUT PREGNANCY AND THE POSTPARTUM PERIOD, WE MEASURELINGS LIKE HOW DO THEY RESPOND TO STRESS WHILE THEY'RE PREGNANT. WE'VE DONE STUDIES WHERE THERE ARE HP A A PSYCHOSTRESS OR PHYSIOLOGY LIKE HEART RATE AND EYE BLINK WHEN THEY DO THE STAR-RESPONSE BUT THERE ARE MANY WAYS IN WHICH WE PHENOTYPE THE STRESS RESPONSIVENESS OF THIS PREGNANT POPULATION, WE ALSO CONDUCTED 3D ULTRASOUND OF FETAL ADRONAL VOWELUME BECAUSE WE'RE INTERESTED AGAIN IN HOW MOM'S LIFE HISTORY, NOT JUST HOW SHE PERCEIVES STRESS AND HISTORY BUT HOW HER LIFE HISTORY MIGHT IMPACT THE DEVELOPMENT OF THE BABY'S STRESS SYSTEM OR THE HYPOTHALAMIC PILOT PITUITARY ACCESS AND YOU CAN MEASURE THE FETAL ADRENAL WHERE COTTER SOLIS PRODUCED THE STRESS HORMONE AND BE ABLE TO ASSESS WHETHER THERE'S IMPACT OF MATERNAL STRESS, NOT JUST HER PERCEIVED STRESS AND PREGNANCY BUT EARLY STRESSOT BABY'S HP A ACCESS DEVELOPMENT. AGAIN IT'S JUST THE FEIGN ILLEGALS ADRENAL, WE CAN'T MEASURE THE HYPE THALAMUS OR ANYTHING LIKE THAT, BUT THESE CAN BE LARGER OR SMALLER DEPENDING UPON AN EXAMPLE FOR ADULTS TAKING EXOGENOUS GLUCOCORTICOIDS OR UNDER SIGNIFICANT STRESS AND THEN WE ALSO, I WILL SHARE THESE DATA WITH YOU, MATERNAL INFANT STRESS REGULATION AT THE BABY'S SIX MONTH EVALUATION. SO, WE ARE ALSO INTERESTED NOT ONLY IN WHAT HAPPENS TO THEIR FETAL ADRENAL DEVELOPMENT BUT HOW DOES THAT CONTRIBUTE TO HOW THEY RESPOND TO A STRESSOR WHEN WE STRESS THEM AT SIX MONTHS OF AGE. NOW THIS IS AN EXAMPLE OF A STUDY THAT I THINK HAS REALLY GREAT TRANSLATIONAL POTENTIAL BUT I'M HIGHLIGHTING THE INDIVIDUALS IN OUR LABORATORY BECAUSE OUR RESEARCH COORDINATORS THESE FIRST THREE LADIES ARE SOME MUCH THE WOMEN WHO MADE THE OBSERVATION OF HOW THE WOMEN BEHAVE WHEN THEIR BABIES ARE UNDERGOING THE STRESS STUDY THAT MADE US DESIGN A BRAND NEW STUDY AND THIS BRAND NEW STUDY. IT REALLY TO ME, EMPHASIZES THE IMPORTANCE OF TEAM WORK, IT EMPHASIZES THE IMPORTANCE OF EVERY SINGLE MEMBER OF YOUR TEAM, WHETHER THEY'RE A Ph.D. OR JUST GRADUATED FROM COLLEGE, THEY'RE INTERACTING WITH YOUR RESEARCH PARTICIPANTS AND THEY HAVE SOMETHING TO TELL YOU THAT YOU NEED TO LISTEN TO AND IT FTION THIS IDEA CAME UP BECAUSE WE WERE MEETING TOGETHER, TRACEY'S TEAM, PRECLINICAL TEAM AND ADVISORS AND COORDINATORS AND JUNIOR FACULTY MEMBER HAS TAKEN THIS ON THIS ON. SO THESE INFANTS OF MOTHERS OF AGE OF HIGH ADVERSITY VERSUS LOW ADVERSITY, BUT THESE OCCURRED NOT DURING PREGNANCY BUT BEFORE THE MOTHERS WERE 18. THESE BABIES WERE TAKEN INTO ANOTHER ROOM, SEPARATED FROM THE MOM, THE MOM KNEW THEY WERE GOING TO OBVIOUSRY BE TAKEN, SEPARATED FROM MOM AND THEY UNDER WENT A RESTRAINT STRESS FOR THREE MINUTES SO THEY CAT IN A CAR CHER AND SOMEBODY HELD DOWN THEIR ARMS AND DIDN'T LOOK AT THEM AND THEN WE HAD THREE LOUD NOISE BURSTS SO IT IS STRESSFUL FOR THE BABY. BUT BELIEVE IT OR NOT, WE HAVE A VARIED RESPOND FROM THE BABIES AND WE HAVE A VARIED RESPONSE FROM THE MOM, OTHERS ARE LIKE THIS IS NO BIG DEAL AND OTHERS GET IRRITATED AND SOME START TO CRY. SO OBVIOUSLY IF THE BABY--WE DO TELL THE MOM, IF THE BABY CRIES FOR MORE THAN I THINK IT'S OH GOSH, MOARP THAN A MACHINE UTR OR SOMEWHERE BETWEEN 32ndS OR A MACHINEUTE, WE STOP, AND WE BRING THE BABY BACK. WELL WHAT WAS IT THAT RESEARCH COORDINATORS NOTICED. THEY NOTICE THAD SOME MOMS WERE LIKE HERE, TAKE MY BABY, GO AHEAD. HAD NO QUESTIONS. DIDN'T SEEM TO BE OVERLY CONCERNED ABOUT WHAT WAS HAPPENING AND THEN OTHER MOMS WERE LIKE, YOU PROMISE ME THAT IF THE BABY STARTS TO CRY, IF JOEY STARTS TO CRY YOU'LL BRING THE BABY BACK RIGHT AWAY AND THE MOM SEEMED HYPED UP AND ASKED LOTS OF QUESTIONS AND THEY'RE LIKE WHAT IS GOING ON HERE, WEAN HAVE THESE TWO DIFFERENT WAYS WOMEN ARE RESPONDING AND WE STARTED THINKING ABOUT IT, WE WONDERED COULD ADVERSITY CONTRIBUTE TO A STRESS RESPONSE OR A LACK OF STRESS RESPONSE IN THESE WOMEN. SO WE ACTUALLY DECIDED TO STUDY THE MOMS IN THIS. SO MOST PEOPLE THINK THAT YOU THINK YOU HAVE TO PUBLIC SPEAKING WITH PARTICIPANTS IN ORDER TO GET THE COTTER SOLLEVELS TO ELEVATE. BUT WE WILL SHOW THAT YOU TAKING THE BABY AWAY FROM THE MOM, THE COTTERIS OLDER PEOPLE LEVELS INCREASED WE DID IT, BUT WE STARTED TO DOING THIS IN THE MOMS BECAUSE WE THOUGHT MAYBE THE MOMS BEHAVE DIFFERENTLY BECAUSE OF THEIR AXIS BECAUSE THEIR OBSERVED BEHAVIOR IS DIFFERENT. THIS IS THE RESPONSE OVERTIME FROM OUR MOMS WHO HAD LOW LEVELS OF ADVERSITY IN CHILDHOOD, AND THIS IS FROM OUR MOMS WHO HAD HIGH LEVELS OF ADVERTSITY IN CHILDHOOD. OKAY. SO THERE IS A BLUNTING OF STRESS RESPONSIVENESS IN THE MOMS WHO HAD HIGH LEVELS OF ADVERSITY AND CHILDHOOD. OKAY? NOW HOW DO WE GET TRANSLATIONAL ABOUT THAT? WELL, KATIE WAS SITTING THERE. SHE'S TRACEY BABRUTUS S, POST DOC, SHE SAID YOU KNOW WHAT I CAN MAKE AN ANIMAL MODEL OF THIS AND SO SHE DECIDED TO MAKE AN ERKICOLOGICALLY RODENT MODEL OF MA--MATERNAL SEPARATION, SO SHE CREATED A BOX WHERE THE MOUSE MOTHER COULD HEAR AND SMELL HER OFFSPRING AND SHE HAD MALES IN THE CAGE AND THEY COULD NOTN'T GET TO THE OFFSPRING SO HOW MUCH STRESS AND HOW MUCH CORTISOL LEVELS DID THE RODENTS HAVE? SO SHE STRESSED THESE MOMS IN THAT PERIPIEWBITTAL WINDOW SO SHE STRESSED THEM AND THEN SHE HAD SOME NOT STRESSED, JUSTS NORMAL CONTROL, SHE LET THEM GROW UP, GET PREGNANT, HAVE THEIR BABIES AND THEN SHE EXAMINED HOW THEY RESPONDED IN THIS PARTICULAR PARADIGM SO SHE MEASURED SIGN OF TRAVEL, AND THEN IN CONTROLS IN THE ANIMALS THAT HAD NEVER BEEN STRESSED IN THE WINDOW, THEY HAD A CONSISTENT INCREASE IN TRYING TO GET TO THE BABIES. THEY FOUND THIS--WHAT WE WOULD THINK IS DISTRESSING BECAUSE THEY KEPT GOING AFTER IT. THE STRESSED MOMS THAT WERE IN THAT PIEWBITTAL WINDOW GAVE UP. THEY STOPPED GOING AFTER THEIR OFFSPRING AND THEIR CORTICOSTROL LEVEL WAS DAMPENED SO THIS IS A MODEL OF HOW THE MUSE COULD BE USED TO REFLECT WHAT WAS GOING ON IN HUMANS AND VICE VERSA AND WE WERE DOING THESE AT THE SAME TIME. WE HAD NO IDEA THIS WOULD WORK OUT BUT IT WAS LIKE WE HAD THE FUNDING TO BE ABLE TO BE CREATIVE AND WE COULD LOOK AT THIS NOW ONE THING THEY CAN DO IN AN ANIMAL MODEL THAT YOU CAN'T DO IN THE HUMAN THEY COULD TAKE A PIECE OF THE HYPOTHALAMUS, THEY TOOK IT OUT OF THESE MICE AND DID AN RNASEQ, AND THEY SAW THAT THE PERIPIEWBITTAL STRESS WAS UPREGULATED IN THE GENES IN THE PBN AND THESE WERE EARLY GENES THAT WOULD HAVE DOWN STREAM TARGETS ON VARIOUS TRANSCRIPTAL AND TRANSLATIONAL REGULATIONULATION AND WE KNOW THAT BECAUSE OF SOME OF THE JEERNS I WON'T GO INTO, THAT THEY WILL HAVE AN IMPACT ON HOW THE PVN ENDS THIS STRESS. SOPHISTICATEDY WE COULD SHOW THAT THE STRESS HAD THIS ENDURING EFFECT THAT SHOWED UP AND HOW THE MOTHER WAS INTERACTING WITH HER OFFSPRING. AND WHAT WE DIDN'T DO IN THE ANIMALS IS WE DIDN'T ACTUALLY LOOK AT THE OFFSPRING STRESS RESPONSE BUT I CAN'T SHOW YOU A PICTURE BUT I CAN TELL YOU FROM THE HUMAN DATA THAT OUR BABIES REFLECT MOM. SO THE BABIES WHOSE MOMS HAD BLUNT DISTRESS RESPONSES THEY HAD BLUNT DISTRESS RESPONSE. SO AGAIN, WE'RE REALLY, REALLY INTERESTED. IS THIS A COOL MODEL FOR BEING ABLE TO ELECTRIC AT THIS INTERGENERATED RAIGDZAL TRANSMISSION OF STRESS. SO IT'S ALWAYS ABOUT THE MOTHERS AND I KNOW ALL THE MOTHERS IN THE ROOM ARE GETTING SICK OF THAT SO WE'RE GOING TO MAKE IT ALSO ABOUT THE FATHERS. AND THIS IS ROY WADE WHO IS ONE OF OUR BIRCWH SCHOLARS. AND HE IS WORKING IN PHILADELPHIA HE IS VERY, VERY PASSIONATE ABOUT COMMUNITY HEALTH BUT HE HAS A Ph.D. SO HE REALLY APPRECIATES THE BASIC SCIENCE AND ONE OF THE THINGS THAT'S REALLY COOL IN TRACEY'S LAB AND OTHERS LABS WE'VE BEEN ABLE TO SHOW THAT PATERNAL STRESS EARLY IN LIFE ACTUALLY HAS SOME EPIGENERATEDETEC REGULATION IN THE SPERM THAT CAN BE PASSED ON TO THE OFFSPRING SO THAT YOU SEE SEX DIFFERENCES IN THE OFFSPRING'S BEHAVIOR. HE'S GOING TO TRY TO TRANSLATE THAT INTO A HUMAN MODEL. IT'S NOT SIMPLE IN A HUMAN. IF YOU'RE A YOUNG MAN AND YOU'VE BEEN ABUSED NEGLECTED AND LIVE INDEED A DIFFICULT SITUATION, IT'S GOING TO CHANGE YOUR BEHAVIOR. AND HOW YOU PARENT IS GOING TO IMPACT YOUR OFFSPRING, NOT JUST WHAT'S GOING ON IN YOUR SPERM. SO WE'RE AT THIS POINT WORKING WITH ROY, I'M SORRY THROUGH THE NATIONAL ADD HEALTH STUDY. HE'S BEEN ABLE TO SHOW SO FAR LOOKING RETROSPECTIVELY AT THIS PARTICULAR COHORT, SO THESE ARE YOUNG MEN THAT WERE ASSESSED IN MIDDLE AND HIGH SCHOOL UP TO AGE OF ABOUT 24-32 AND OF THESE YOUNG MEN ABOUT 1800 OF THEM ARE ALREADY FATHERS. AND THEY CAN SELF-REPORT WHAT THEIR CHILD'S HEALTH IS. AND SO FOR THOSE FATHERS THAT REPORT CHILDHOOD ABUSE AND MALTREATMENT, THE RISK FOR REPORTED LEARNING PROBLEMS IN ADHD, IN THEIR OFFSPRING WAS ABOUT TWO FOLD. NOW THERE ARE MANY LIMITATIONS TO THIS PROJECT BECAUSE IT'S A BET RETROSPECTIVE AND WE CAN'T CONTROL FOR WHAT'S GOING ON MOMS SO SHE'S DESIGNING FOR HIS K23 TO EXAMINE PATERNAL ACE EFFECTS OF RISK FOR COGNITIVE AND PATERNAL BEHAVIOR BECAUSE HE WANTS TO ISOLATE THIS PATERNAL ACE HISTORY ASK IMPACT ON THE FATHER'S PARENTING BEHAVIOR AND HOW THAT CONTRIBUTES TO OFFSPRING AND HE WILL CONTROL FOR MOM'S ACE HISTORY AND THE OFFSPRING HE HAS ON RECORD ON 20,000 CHILDREN WHO ARE BEING TREATED FOR MEDICAL CARE AT THE CHILDREN'S HOSPITAL OF PHILADELPHIA. SO HE CAN ACTUALLY DID A LOT OF THIS WITH MEDICAL RECORDS IN FRONT OF HIM, TO TELL US WHICH CHILDREN ACTUALLY HAVE A MEDICAL DIAGNOSIS AND HE DOESN'T HAVE TO RELY ON THE FATHER'S SELF-REPORT. AFTER HE'S DONE THIS, HE CAN THEN LOOK AT THAT HERITABLE RISK, IS THERE SOMETHING GOING ON, ENDURING AND FATHER'S SPERM THAT IS PASSED ON IN SEMEN, BEING PASSED ON TO THE OFFSPRING AND THAT'S SOMETHING THAT'S DOWN THE ROAD AND YOU CAN IMAGINE KIND OF THE ETHICS INVOLVED WITH ALL OF THAT. I MEAN THIS WILL BE HUGE IF THIS IS REALLY, YOU KNOW PANNING OUT IN THE WAY WE THINK IT WILL BASED UPON THE ANIMAL LITERATURE AND ROY IS REALLY--HE'S REALLY A WONDERFUL, WONDERFUL THINKER ABOUT HOW HANDLES FOR THE COMMUNITY MESSAGING ABOUT THESE KINDS OF ISSUES. SO MOVING ON BECAUSE I HAVE A FEW MINUTES LEFT, TALKING ABOUT THE AGING. ALL RIGHT, SO, DOES EARLY CHILDHOOD ADVERSITY INCREASE RISK FOR COGNITIVE AND MOOD CHANGES AS WOMEN GO THROUGH MENOPAUSE? WE KNOW WOMEN WHO ARE GOING THROUGH MENOPAUSE, THEY ARE TWICE AS LIKE TO EXPERIENCE THEIR FIRST MAJOR DEPRESSIVE EPISODE, EVEN IF THEY'VE NEVER HAD AN EPISODE OF DEPRESSION BEFORE, IF IF YOU'RE A PERIMENOPAUSAL WOMEN AND YOU HAD A MAJOR DEPRESSIVE ILLNESS IN PREMENOPAUSE WE KNOW YOU'RE FIVE TIMES MORE LIKELY TOO HAVE A RELAPSE WHEN YOU GO THROUGH THIS. IT'S A MAJOR HORMONAL SHIFT IN WOMEN'S LIVES, NOT JUST IN THEIR HEAD, IT REALLY DOES HAVE AN IMPACT ON A CERTAIN SUBGROUP OF WOMEN. NOT EVERYBODY. SOME PEOPLE SAIL THROUGH, MY MOTHER FOR ONE SAYS I DON'T KNOW WHEN IT HAPPENED TO ME. I JUST ONE DAY WOKE UP AND I WAS POST MENOPAUSAL AND NEVER HAD A SINGLE PROBLEM. BUT THAT'S NOT THE PATIENT WHO COMES IN MY DOOR AND AS A PSYCHIATRIST THIS IS THE WOMEN I TREAT. THESE WOMEN ARE NOT ANXIETY OR--ANXIOUS OR DEPRESSED WE SEE PSYCHOTIC WOMEN AS WELL. WE ALSO KNOW THAT COGNITIVE DIFFICULTIES ARE COMMON IN THESE WOMEN, IF YOU UNDER GO IT BEFORE THE AGE OF 40 WHICH A LOT OF WOMEN DO WHEN THEY UNDERGO RISK REDUCTION FOR CANCER RISK REDUCTION, THOSE WOMEN ARE MORE LIKELY TO HAVE MOOD AND COGNITIVE DIFFICULTIES. SO AGAIN THERE'S A SUBSET OF WOMEN THAT WERE GOING THROUGH MENOPAUSE THAT WE'RE NOT SERVING. WE ARE TRYING TO UNDERSTAND WHAT MAKES WOMEN HAVE OTHER DIFFICULTIES AND WOMEN SAIL THROUGH. SO WITH PART PART UMKC DEPRESSION, ANOTHER POINT IN THE REPRODUCTIVE LIFE SPAN WITH PRODUCTION, IT'S ONLY 1015% OF WOMEN THAT EXPAND THE ILLNESS BUT ALL OF THESE GO THROUGH THE HORMONAL FLUCTUATIONS SO WHY DOESN'T EVERYBODY HAVE SOME KIND OF MOOD CHANGE. WELL WE KNOW THE BRAIN HAS TO ADJUST, AND ONE OF THE MAJOR QUESTION SYSTEM AGAIN, DOES EARLY LIFE ADVERSITY HAVE EN ENDURING EFFECT ON THE BRAIN OR INFLAMMATION OR YOUR RESPONSE TO THE ACTUAL EVENTS OF MENOPAUSE OR PREGNANCY, DO THESE EARLY LIFE EVENTS CONTRIBUTE TO THIS ENDURING EFFECT AND THAT'S THE QUESTION WE ARE TRYING TO ASK AND WE'VE BEEN USING ELEN FREEMAN'S 14 YEAR LONG AGING COHORT. WE HAVE BEEN USING BRAIN IMAGING, RODENT MODELS, CADEY MORRISON WHO WORKS WITH TRACEY DOES THE AGING MODELS FOR THE RODENTS AND THEY HAVE SOME--I WON'T GO INTO THEM BUT THEY HAVE INTERESTING DATA ABOUT RISK AND RESILIENCE IN RODENT WHO IS UNDERGO EARLY LIFE STRESS AND THE EARLY LIFE STRESS AND CONTEXT OF SOCIAL SUPPORT SEEMS TO LEAD TO--AGAIN THEY'RE NOT THE FIRST TO SHOW THIS BUT AGAIN IT IS INTERESTING THAT THIS SOCIAL SUPPORT CAN MITIGATE THE EFFECTS OF STRESS SUCH THAT THE ANIMAL WHEN IS THEY GET OLDER ACTUALLY PERFORM BETTER AND WE'VE ALSO BEEN LOOKING AT ISSUES OF INFLAMMATION IN THIS PARTICULAR POPULATION. SO I'LL GO THROUGH THESE. THIS IS THE PENN OVARIAN AGING COHORT. IT'S A COHORT THAT WAS BASICALLY CALLED BY RANDOM DIGIT DIALING. CAN YOU BELIEVE THAT. IN THE 1990S PEOPLE ACTUALLY PICKED UP THERE THEIR PHONE. BUT YOU WOULD NEVER GET THIS SAMPLE--THESE DAYS. BUT THE SAMPLE WAS HALF CAUCASIAN AND HALF AFRICAN AMERICAN BY DESIGN. EVERYONE WAS ENROLLED INLET PREMENOPAUSAL STATE. WHAT DOES THAT MEAN? THEY WERE ENROLLED BEFORE THEY HAD CHANGES IN THEIR MENSTRUAL CYCLES AND FOLLOWED ACROSS EACH STAGE. THE LAY PREMENOPAUSE IS WHEN THEY'RE STARTING TO MINOR CHANGES IN CYCLE, EARLY TRANSITION IS WHEN YOU HAVE ONE SKIPPED CYCLE AND THE PREVIOUS 12 MONTHS, LATE TRANSZITION IS WHEN YOU HAD THREE-11 MONTHS OF AMEN ORRERIA AND THEN POST MENOPAUSAL IS THIS KIND OF ARBITRARY, YOU HAVEN'T HAD A PERIOD FOR 12 MONTHS. SO THIS IS A PAPER THAT WAS PUBLISHED IN JA MA PSYCHIATRIST IN 2014 AND ELEN LOOKED IN HER SAMPLE AT THE RISK FOR MAJOR DEPRESSIVE ILLNESS ACROSS THE TRANSITION. WHAT DID IT LOOK LIKE AS FAR AS THE NATURAL HISTORY. I'VE ALREADY TOLD YOU THESE WOMEN WERE TWICE AS LIKELY TO HAVE A MAJOR DEPRESSIVE EPISODE EVEN IF THEY NEVER HAD A DEPRESSION BEFORE. BUT WHAT SHE DID IS SHE SAID IF ZERO IS WHEN THEY STOP MEN STRAIGHTING AND EVERYTHING BEFORE THAT IS THE YEARS LTD.ING UP TO THEIR LAST MENSTRUAL PERIOD AND EVERYTHING ON THIS ISED THE YEARS AFTER THE THEIR LAST MEN MENSTRUAL PERIOD ON THIS SO THESE WERE WOMEN WHO CAME IN THE STUDY BEFORE THEY WENT THROUGH ANY PERIMENOPAUSE HAD A MAJOR DEPRESSIVE EPISODE SO THESE ARE THE LIGHT BLUE BARS AND YOU CAN APPRECIATE THAT AS YOU GO THROUGH THE FINAL MIN TRAL PERIOD, THERE ARE A LOT OF PEOPLE WITH DEPRESSION, AND IT DOES DECREASE A LITTLE BIT. BUT WHO ARE THESE PEOPLE? THESE ARE THOSE PEOPLE I WAS TELLING BUT THAT HAD NEVER HAD A MAJOR DEPRESSIVE ILLNESS. THEY ONLY HAD THE ILLNESS AND THE PERIMENOPAUSE. GUESS WHAT? BY THE TIME THAT THEY FINISHED HAVING THE MENOPAUSE, IT'S ALMOST NONEXISTENT. SO THIS IS THEIR RISK WINDOW. AND AGAIN, WE WONDERED DO ADVERSE CHILDHOOD EXPERIENCES INCREASE THE RISK IN THIS POPULATION MORE SO IN THIS POPULATION BECAUSE THIS, WE KNOW THAT ADVERSITY INCREASING THE LIFE SPAN.PRESSION ACROSS THE- BUT WE WANTED TO KNOW IS THERE SOMETHING SPECIAL ABOUT THE RELATIONSHIP BETWEEN EARLY ADVERSITY AND WHAT'S GOING ON WITH THESE PARTICULAR WOMEN. AND THIS WAS THE DATA THAT THEY WERE JUST TALKING ABOUT THAT WAS PUBLISHED IN THE JOURNAL OF CLINICAL PSYCHIATRIST. THIS IS ON THE RISKER FOR DEPRESSION, THIS IS LIFETIME DEPRESS IN THE POPULATION AND THIS IS RISK FOR INCIDENT, MENOPAUSE DEPRESSION. AND WE ARE SHOWING YOU THESE DATA TEASING OUT THE IMPACT OF PREPIEWBITTAL VERSUS POST PIEWBITTAL ADVERSITY AND WHRA YOU CAN SEE WHEN IT COMES TO FOR RISK FOR LIFETIME DEPRESSION, THERE IS A SIGNIFICANT INCREASE WITH THOSE WITH TWO OR MORE PREPIEWBITTAL ACES, REGARDLESS OF HOW MANY ACES THEY HAVE. BUT LOOK AT THE RED LINE. THAT'S THOSE THAT HAVE ONLY HAD ONE PREPIEWBITTAL ACE. THIS IS THE GROUP THAT FASCINATES ME BECAUSE THIS IS SUGGESTIVE THAT THESE ARE RESILIENT INDIVIDUALS, THESE ARE PEOPLE WHO HAD ONE PREPIEWBITTAL ONSET OF ACE AND IF THEY GO ON TO HAVE MORE ACES LATER IN THE POST PIEWBITTAL WINDOW, THEY STILL HAVE LOWER LEVELS OF DEPRESSION THAN THE OTHER GROUPS. SO THERE'S NOT ONLY RISK SOCIETIED WITH THESE ACES, HAVING TWO OR MORE, BUT IF YOU HAVE A LITTLE BIT OF ADVERSITY, EVEN BEFORE YOU GET YOUR FIRST PERIOD, THAT SORT OF PREPIEWBITTAL WINDOW IT DOES SEEM TO BE A STRESS INOCULATION. BUT AGAIN, I SAY THAT TENTATIVELY, THIS HAS TO BE REPLICATED BUT ANIMAL MODELS SUGGEST THIS IS TRUE BECAUSE THERE'S BEEN NONHUMAN PRIMATE STUDIES AS WELL TO SUGGEST THAT A SMALL AMOUNT OF ADVERSITY CAN HAVE A PROTECTIVE EFFECT. SO WE KNOW FROM THESE DATA THAT THOSE WITH TWO OR MORE PIEWBITTAL ACES HAVE THE GREATEST RISK FOR LIFETIME DEPRESSION, ONE PREPIEWBITTAL APPEARS PROPROTECTIVE AND THE PATTERN IS SIMILAR FOR THE DEPRESSION GROUP. IT'S MUCH SMALLER SAMPLE SO IT'S A LITTLE HARDER TO SHOW THE EFFECT. AND AGAIN THIS WAS PICKED UP BY FOSHES AND HEALTH DAY AND A WHYY, AND I WILL END UP TALKING ON COGNITION ACROSS THE NATURAL MENOPAUSE AS WELL AS SURGICAL MENOPAUSE AND HOW DOES ACE CONTRIBUTE TO THAT. BECAUSE I'VE SHOWN THAT IT HAS A IMPACT ON DEPRESSION. SO THIS WAS PUBLISHED FOCUSING VERBAL INFORMATION AS WELL AS I WILL SHOW YOU DELAYED. AND THIS IS THEIR PREMINO PAUSE PERFORMANCE AND THIS IS JUST SHOWING YOU DECK RAMENT OR AND PERFORMANCE AS THEY GO ACROSS THE TRANSITION AND IF YOU LOOK AT THE DELAYED RECALL WHICH IS A MORE DIFFICULT TASK, AS EARLY AS THE EARLY TRANSITION, YOU HAVE A SIGNIFICANT DECK RAMENT AND THE ABILITY TO PERFORM THE TASK OF THE THIS IS REGARDLESS OF THE HISTORY. WE NEEDED ON SHOW THAT MENOPAUSE EXERTS AN AGE-INDEPENDENT EFFECT ON COGNITION. BECAUSE EVERYBODY HAD ALWAYS THOUGHT, OH IT'S JUST AGE, IT'S JUST AGE. BUT THESE DATA CONTROL FOR AGE, BODY MASS IMDEXTRAN SULFATE, DEPRESSION, ANXIETY, WHOLE HOST OF FACTORS, EDUCATION, SO AGAIN WE ASKED AS EARLY ADVERSITY INCREASED RISK EMPLOY SO WHAT WE DID, IS WE TOOK A SAMPLE MOVING TO A COHORT BRIEFLY AND I WILL COME BACK, BECAUSE THIS IS A LARGER SAMPLE, WE DID AN ONLINE SURVEY OF WOMEN WHO HAD UNDERGONE OH UFRECT ME BECAUSE OF THE PROCEDURES WE HAD DATA OUR 400 TIME POINT AND ABOUT 453 WENT DID TIME TWO. WE COMPLETED ASSESSMENTS ON A COGNITIVE BATTERY ONLINE AND THIS IS TRYING TO DO THE COMPLETE STUDY ONLINE AND HAD IS WORK DONE BY SUSAN DOM CHECK IN COLLABORATION WITH HER AND NIGH STUDENT, AND THIS SHOWS LOOKING AT EXECUTIVE FUNKDZING MEASURES, THOSE WITH HIGH ADVERSITY, SELF-REPORT HAVING GREATER EXECUTIVE FUNCTIONING DIFFICULTIES, WHAT DO I MEAN EXECUTIVE FUNCTIONING, WELL THIS IS ORGANIZATION AND ACTIVATION FOR WORK, AGAIN, HIGHER LEVELS, DIFFICULTY WITH ATTENTION AND CONCENTRATION, SIGNIFICANTLY HIGHER LEVELS IN THE HIGH ACE GROUP. ALERTNESS, EFFORT AND PROCESSING SPEED, AGAIN, HIGHER AND THE HIGH ACE GROUP, MANAGING EFFECTIVE INTERFERENCE AND WORKING MEMORY ASSESSING RECALL, ALL OF THESE ARE SIGNIFICANTLY EFFECTED BY ACE SMGHT WHAT ABOUT OBJECTIVE PERFORMANCE, THAT WAS HOW THEY FELT THEY WERE PERFORMING. THEY DID A DISCONTINUED ATTENTION TASK, THE HIGH ACE GROUP DID WORSE, THEY DID A WORKING MEMORY TASK, HIGH ACE GROUP DID WORSE. SO AGAIN ADVERSITY IN THIS POPULATION AND AGAIN THEY HAD NO IDEA THAT WE WERE LOOKING AT ADVERSITY IN RELATIONSHIP TO COGNITION, THEY JUST PERFORMED THE TASK OR REPORTED ON THE EXECUTIVE FUNCHESSING AND WE SEE THERE'S AN ENDURING EFFECT SOW HOW DOES THIS GET UNDER THE SKIN. THIS IS A COHORT AND WE RAIDED THE FREEZER BECAUSE WE WANTED TO KNOW IF LOSS OF ESTROUGH ATOM DIAL AT MENOPAUSE WOULD HAVE AN IMPACT ON CYTOKINES BECAUSE WE KNOW FROM OTHER STUDIES THAT ESTRADIOL DAMPENS SYNTHESIS OF A NUMBER OF PROINFLAMMATORY AGENTS AND BECAUSE THESE WOMEN WERE ONLY HAVE MOOD AND COGNITIVE SYMPTOMS IN THE MENOPAUSE TRANSITION WE THOUGHT IT'S THE RELATIONSHIP BETWEEN ADVERSITY AND INCREASE INFLAMMATION AND CHANGE IN ESTRADIOL LEVELS. SO WE RAIDED THE COHORT AND TOOK OUT A PUNCH OF SAMPLES. OUR LADIES ONLY DID FOUR TASKS. WE DID NOT PICK AND CHOOSE THE ONES THAT WERE SIGNIFICANT. I AM SHOWING YOU THE DATA. THEY DID A SIMPLE COPY TASK, PROCESSING SPEED KIND OF WORK AND AGAIN THE DELAYED VERBAL RECALL AND IMMEDIATE VERBAL RECALL. AND WE LOOKED AT FOUR DIFFERENT CYTOKINES WE DID NOT DO A FISHING EXPEDITIONS. I HIGHLIGHTED THE SIGNIFICANT ONES AND THESE ARE THREE-WAY INTERNATIONS WE CONTROL FOR AGE, RACE, BMI, SPOKING AND WHAT HAVE YOU. WHAT I'M SHOWING YOU HEAR IS THE RED LINE, HIGH ACE GROUP, BLACK LINE IS THE LOW ACE GROUP. BY THE TIME THEY'RE IN THE PERIMENOPAUSE, IL-SIX LEVELS AS THEY INCREASE THEIR COGNITION ON IMMEDIATE RECALL DECLINES, AND IT GETS WORSE IN THE POST MENOPAUSE THAT SIGNIFICANT INTERACTION OR TREND ISHT ACTION FOR THE DELAYED WORD RECALL IS A SIGNIFICANT THREE WAY INTERACTION, AGAIN SUGGESTING THAT AT THIS POINT WHEN THEY'RE PERIMENOPAUSE, INTERACTION BETWEEN HAVING HAD ADVERSITY AND HAVING HIGHER LEVELS OF CYTOKINES IS ASSOCIATED WITH WORSE COGNITIVE PERFORMANCE, THE SAME IS TRUE FOR ILONE BETA. SO WE THINK THAT ACE HISTORY MIGHT BE CONTRIBUTING TO CHANGINGS IN COGNITION AT MENOPAUSE AND PERHAPS MOOD. WE WILL NOW LOOK AT MOOD IN THIS POPULATION. PERHAPS THROUGH THESE ALTERATIONS AND CYTOKINES. BUT I'M JUST GOING TO TAKE TWO MINUTE FIST I CAN? ONE? AND SHOW THAT THE BRAIN ALSO UNDERGOES ENDURING CHANGES. THIS WILL BE QUICK, IT'S THE DORSAL LATERAL FREE RADICALS FRONTAL CORTEX. MY TAME HOME POINT FOR MY DOCTORAL STUDENT IN JAMES LOGHEAD ADVERSITY INCREASESACIVATION IN THIS BRAIN REGION DURING WORK WOG MEMORY AND ESTRADIOL REVERSES THAT AND WE KNOW THAT CONNECTIVITY IS IMPORTANT FOR EXECUTIVE FUNCTIONING AND WE KNOW THAT EARLY CHILDHOOD ADVERSITY DECREASES WITHIN NETWORK CONNECTIVITY WHICH IS AGAIN VERY IMPORTANT WITH RESPECT TO WORKING MEMORY. SO THE MAIN TAKE HOME MESSAGES FROM THESE TWO SLIDES BECAUSE I KNEW I WOULD DO THEM QUICKLY BUT I WANTED TO SHOW YOU IS THAT EARLY ADVERSITY HAS ENDURING IMPACT ON HOW THE BRAIN RESPONDS WHEN IT'S TRYING TO DO A WORKIN MEMORY TASK WHEN IS IMPORTANT FOR THINGS LIKE MULTITASK AND OTHER ASPECTS OF EXECUTIVE FUNCTION. SO THE BEN--BENEFIT IS, CAN IT MIMIC ADVERSITY, WE CAN MIMIC IN LARGE POPULATIONS AND BROADLY SPEAKING, CHILDHOOD AVERSION IS RELATED WITH COGNITIVE DISORDERS AS WELLA AS SEX BIAS. I SO MANY PEOPLE INVOLVED WITH THIS RESEARCH, IN SUMMARY WE'RE NOT SO LOST IN TRANSLATION, THAT'S MY HOPE. THE ANIMAL MODELS OF STRESS CAN BE USED TO MIMIC HUMAN STRESSORS, ECOLOGICALLY RELEVANT AND CLOSE COLLABORATIONS IN RELATIONSHIPS WITH PEOPLE CAN BE FOSTERED BY P50S AND CYCLIC ROONES, MULTICYCLE ROONES AND ENHANCED TRANSLATIONAL RESEARCH. HUGE STAFF, AND LOTS OF FUNDING. IT WAS ALSO VERY IMPORTANT. SO THANK YOU FOR YOUR ATTENTION. --I APPRECIATE IT. [ APPLAUSE ] NWOW THAT WAS A LOT OF INFORMATION. >> TOUR DEFORCE. >> ABSOLUTELY. DR. GREGORY? >> IT'S VERY INTRIGUING AND PHENOMENAL AND I'M JUST LIKE JAZZED BY YOUR ENTHUSIASM. BUT IT DOES BEG THE QUESTION THAT ANOTHER THING THAT NEEDS TO BE CONTROLLED FOR AS WE'RE FINDING OUT MORE AND MORE IS BIRTH CONTROL. IT'S HORMONAL BIRTH CONTROL BECAUSE THAT'S A BIG HORMONAL SHIFT. >> [INDISCERNIBLE] >> NO I HAVE AN ADOLESCENT THAT'S ON BIRTH CONTROL BUT SOMETIMES IT'S STIMULANTS, FOR YOU KNOW DEPRESSION OR ANXIOUS DISORDERS AND YOU KOIPLE THAT WITH ADVERSE EEIVETS, WHICH IS--EVENTS WHICH IS WHY A LOT OF THEM ARE USING THEM IT'S A MULTIFACTORIAL. >> SUCH AN IMPORTANT FACTOR. WE ACTUALLY COLLABORATED WITH SOME FOLKS THAT AT OREGON STATE. THEY--THERE'S A U54 CONTRACEPT IVE DEVELOPMENT AND THE INSTITUTES BASICALLY SAID IN ORDER TO GO BACK AND GET THE GRANT, YOU NEED ANOTHER P50, YOU NEED A BEHAVIORIAL HEALTH COMPONENT SO WE BECAME THE BEHAVIORIAL COMPONENT TO ANSWER THOSE QUESTIONS. YOU ARE RIGHT. I SEE ADOLESCENT GIRLS WHO COME IN, NEVER DEPRESSED, ALL OF A SUDDEN HAVING DEPRESSION AND IS IT THE BIRTH CONTROL PILLS OR SOMETHING ELSE? YOU'RE ABSOLUTELY RIGHT. >> YES? ,. >> [INDISCERNIBLE]. --CHILDREN WHO HAVE BEEN EXPOSED TO THESE ADVERSE EVENTS LATER IN LIFE, EXPOSE TOWER WHAT IS IT? THERE'S A LOT OF--ON IT. YOU CAN PUT IT ON PUBLIC TV AND SEE ALL SORTS OF THINGS ABOUT [INDISCERNIBLE]. IT'S VERY DEPRESS NOTHING A LOT OF WAYS, TOO. >> WELL. >> IT'S WONDERFUL SCIENCE. >> I APPRECIATE THAT, I KNOW WHAT YOU'RE SAYING. BUT IT ALSO--IT ALSO POINTS TO HOW WONDERFUL, IF I UNDERSTAND THE BASIC SCIENCE HOW INTERVENGSZS CAN BE DEVELOPED, ESPECIALLY WITH MRI SHOWING NEURAL PLASTICITY NOW [INDISCERNIBLE]. AND GROW [INDISCERNIBLE]. >> IT'S IMPORTANT POINT. I CERTAINLY DON'T WANT TO END ON A DOWN NOTE FOR SUCH A WONDERFUL [INDISCERNIBLE] BUT THE BOTTOM LINE IS THIS, REALLY, I MEAN,--CAN YOU PLEASE USE THE MICROPHONE. >> OKAY. THE ONE QUESTION THE REPORTER FROM FOSHS ASKED ME AND THEY ASKED MY E-MAIL, NOW THAT YOU KNOW OF THIS AND HAVE YOU THIS INFORMATION WHAT CAN WE DO TO PREVENT IT AND I TALKED TO MY HUSBAND WHO'S A CHILD PSYCHIATRIST AND I TOLD HIM I LOVED TO ASK THE QUESTION TO THINK ABOUT IT HE SAID I KNOW WHAT TO DO TO PREVENT IT HE SAID DECREASE MALTREATMENT AND CHILD ABUSE IN THE FIRST PLACE. GIVE ADULT AS I LIVEABLE WAINCH BECAUSE WE KNOW, THERE'S VERY CLEAR DATA OUT THERE FROM THE ROCKY MOUNTAIN STUDY WAS CONDUCTED IN NORTH CAROLINA THAT BASICALLY IF YOU YOU KNOW, BASICALLY GIVE THE ADULTS A LIVEABLE WAGE CHILD PSYCHIATRIC SYMPTOMS DECLINE IN THAT STUDY. IT WAS DONE BY DUKE. SO THAT'S JUST ONE STUDY. THERE'S SO MANY THAT HAVE SHOWN THAT AGAIN, PARENTS MENTAL HEALTH IS ALSO GOING TO CONTRIBUTE TO THE CHILD'S MENTAL HEALTH WHETHER IT'S THROUGH INTERGENERATIONAL OR DIRECT ENVIRONMENTAL FACTORS THAT WOULD BE THE BEST WAY IT PREVENT THIS BUT BECAUSE I SEE WOMEN THAT ARE OLD THAN THIS AND CAN'T GO BACK, ONE THING I THINK, YOU KNOW WE NEED TO FOLLOW UP ON THE CYTOKINE DATA. IS IT AN INFLAMMATORY PROCESS. THERE ARE THINGS WE CAN DO TO DECREASE AN INDIVIDUAL'S INFLATION BUT WE NEED THE TIME POINT AT WHICH TO TARGET. IT APPEARS PERIMENOPAUSE, AS FAR AS BRAIN, INTERESTINGLY ENOUGH, SOME DRUGS WE HAVE BEEN TESTING, CHILDHOOD EXPERIENCES HAVE A DIFFERENT RESPONSE, DIFFERENT RESPONSE TO PSYCHOSTIMULANTS AND THOSE DATA WILL HELP US TO SAY, MOVING FORWARD, THIS MAY NOT BE A DRUG THAT WOULD BE HELPFUL FOR YOU OR MAYBE YOU SHOULD BE ON THIS PARTICULAR MEDICATION, AND SO THOSE ARE THE KINDS OF THINGS THAT I THINK ARE HELPFUL BUT YOU HAVE TO HAVE THIS DATA FIRST IN ORDER TO MOVE IN THAT DIRECTION. >> ANY OTHER QUESTIONS BEFORE WE STOP? >> LAST QUESTION. >> THIS IS PHILOSOPHICAL QUESTION BUT I THINK IT'S PERTINENT TO THE TOPICS, SO, WHEN YOU LOOK [INDISCERNIBLE] SEE LIKE TO SEE THE TREMENDOUS STORIES FROM THE [INDISCERNIBLE], AND FAMILIES FAMILIES--FAMINE AND AFRICA MILLIONS OF PEOPLE THESE MECHANISMS WE STUDY IN WESTERN SOCIETIES, YOU KNOW COMPARED TO THE STRESS LEVEL THAT YOU ARE LOOKING HERE IS A SMALL FRACTION OF WHAT THESE PEOPLE GO THROUGH. SO DO YOU THINK THAT'S EPIDEMICS OF THOSE KIND OF NEGATIVE MENTAL THESE WOMEN GO TO MENOPAUSE LATER? >> WELL I THINK THAT'S A GREAT QUESTION AND I'M NOT SURE I CAN ANSWER IT FULLY BECAUSE I THINK THAT'S MORE OF A DISCUSSION BUT A VERY IMPORTANT DISCUSSION BECAUSE I THINK ABOUT IT A LOT. ONE OF THE THINGS I CAN TELL YOU ABOUT MY PATIENT POPULATION IS THAT THESE ARE WOMEN THAT ARE WORKING AT THE TOP OF THEIR INTELLECTUAL GAME AND THEY ARE NOTICING THE CHANGES. SO I THINK IT'S ALSO SOMETHING ABOUT AMERICAN CULTURE THAT WHAT PEOPLE ARE EXPECTED TO DO WITH THEIR BRAIN AT 50, 60, 70 MAY BE DIFFERENT THAN WHAT PEOPLE ARE EXPECTED TO DO WITH THEIR BRAIN IN ROORGT CULTURE. AND IT MAY BE THAT WHAT WE'RE REALLY SEE SUGGEST AN UNMASKING OF VULNERABILITY AND PREFRONTAL CORTEX REGULATING KINDS OF AREAS AND BECAUSE I'M NOT GETTING THESE--I'M NOT GETTING PEOPLE HOME, NOT DOING ANYTHING. THEY'RE NOT NOTICING THESE CHANGES BECAUSE THEY'RE NOT PUSHING THEIRING COGNITIVE LOAD. SO THERE ARE PLENTY OF DATA OUT THERE AND NONADJUSTING HUMANS, RODENTS AND NONHUMAN PRIMATINGS THAT THE MORE YOU PUSH THE COGNITIVE LOAD ISSUES THE MORE DEMANDOT PREFRONTAL CORTEX CAN OR THE CONTROL YOU NEED OR THE COORDINATION BETWEEN THE PFC. SO MY THOUGHT IS SEEING ONE OF THESE WOMEN THAT ARE COME NOTHING AS PROFESSIONALS IS BECAUSE THEY ARE PUSHING THAT COGNITIVE ENVELOPE SO TO SPEAK AND THEY ARE NOTICING IT. I CAN BE CAN'T SAY IF YOU ARE NOT DOING THAT IF YOU WOULDN'T NOTICE IT AS MUCH BUT THAT'S--THAT DOESN'T REALLY ANSWER YOUR QUESTION OTHER THAN TO SAY THAT PART OF IT MAY BE CULTURAL. >> JUST ONE COMMENT. POSSIBLY ONE ARGUMENT GRANCY THIS IS IF YOU LOOK AT EUROPE, GERMANY, TOOK IN A MILLION REFUGEES FROM SYRIA, ONE OF THEM MOST OF THE THEM WERE MALES SO YOU CAN'T REALLY SAY THIS BUT IF THIS MODEL IS CORRECT. MANY OF THESE YOUNG PEOPLE ACTUALLY GO INTO VERY DEMANDING TRAINING AND LANGUAGE TRAINING SO THEY WOULD HAVE TO USE THEIR BRAINS AT LEAST AS HARD AND MAYBE HARDER BECAUSE OF THE DIFFICULTIES. >> SURE. >> SO, I'M NOT SURE IF PEOPLE SEE THAT, YOU KNOW? >> I HEAR WHAT YOU'RE SAYING, I DON'T HAVE MEN COME TO US AS MUCH TO HAVING THESE COMPLAINTS. PART OF WHAT WIRE DOING WITH THE SCORE IS COLLECTING SAMPLES IN MALES, NOW THAT WE KNOW WHAT TO LOOK FOR, WE WILL LOOK IN THOSE SAME BRAIN REGIONS AND SAME TASK WITH MALE POPULATION BEFORE THE SCORE IS FINISHED THIS CYCLE SO THAT WE WILL BE ABLE TO HAVE SOME OF THOSE ANSWERS FOR YOU. >> OKAY. >> THANK YOU SO MUCH AND THANK YOU AGAIN FOR INVITING ME. [ APPLAUSE ] >> THANK YOU SO MUCH NEILL, AND WE ARE AT THE END OF OUR TIME. I WANT TO JUST MAKE SURE THERE ISY--IS NO SINGLE COMMENT THAT THE ADVISORY COMMITTEE WANTS MAKE BEFORE WE GO INTO CLOSED SESSION. >> SEEING NONE-- >> CAN I MAKE ONE COMMENT ABOUT OUR ABILITY TO KIND OF REINFORCE HOW IMPORTANT IT IS TO INCLUDE APPROPRIATE WOMEN IN CLINICAL TRIALS, LIKE THE BIGGEST EXAMPLE OF LATE IS THE BLOOD PRESSURE LOWERING TRIAL WHICH DID NOT REACH SIGNIFICANCE IN WOMEN BUT THEY STOPPED ENROLLING SO NOW I KNOW THAT I AS A STROKE NEUROLOGYST SHOULD BE REDUCING BLOOD PRESSURE TO 120 OR LETIONZ AND THAT WILL REDUCE DEATH AND DISABILITY IN MEN BUT I DON'T KNOW WHAT IT WILL DO ESPECIALLY IF OUR ELDERLY WOMEN ARE FALLING, FRAILER MAY HAVE NOR COMPLICATIONS SO THE CONFIDENCE, ALTHOUGH THE TREND WAS THERE, ACROSSED ONE. SOPHISTICATED SO HOW DO WE ADDRESS THAT FACT AND GET PEOPLE TO CONTINUE TO ENROLL. WE CAN SAY PEOPLE ARE GETTING MORE AWARE OF IT BUT UNLESS WE ENFORCE THAT WAS IN THE NEW ENGLAND JOWRN WILL OF MEDICINE AND THAT WILL BE THE GUIDELINES IN HOW WE TREAT PEOPLE WITH HYPER TENSION SO THAT'S A GREAT EXAMPLE OF SOMETHING WE REALLY HAVE TO STRESS BECAUSE-- >> IF THEY DID, I THINK THEY JUST ENROLLED MORE MEN AS USUAL. THE PROBLEM WITH THAT IS IF YOU SEE A BIG THING THAT'S GOING TO CHANGE GUIDELINES, PERHAPS CAN YOU STOP ENROLL NOTHING MEN WHEN YOU REACH SIGNIFICANCE AND THEN HAVE KIND OF AN ADAPTIVE TRIAL DESIGN CAN YOU CONTINUE TO ENROLL WOMEN UNTIL YOU EITHER REACH FUTILITY OR GET A SIGNIFICANT RESULT. >> RIGHT. >> SO WHAT I'M HEARING IS LESSONS LEARNED FROM THE SPRINT TRIAL, WE THEED--NEED TO TALK MORE ABOUT DESIGNS THAT WILL ALLOW US TO KNOW HOW TREATMENTS WORK IN MEN OR WOMEN IF THEY ARE A POWER TO DETECT SEX DIFFERENCES OR EXPLORE EFFICACY SEPARATELY FROM MEN IN WOMEN WHICH MOST ARE NOT, YOU WOULD LIKE TO HEAR MORE DISCUSSION OF STRATEGIES AND WAYS TO DO THAT. >> AND CONTINUE TO ENROLL. >> SO ADAPTIVE TRIAL DESIGN MIGHT BE ONE WAY BUT THERE MAY BE OTHER WAYS TOO IN HOW THE TRIAL'S DESIGN FRIDAY THE BEGINNING. >> RIGHT. >> ANY OTHER LAST COMMENTS? >> DR. GREGORY? IF I HEAR ANYTHING FROM YOU? >> I'M STILL ALIVE BUT I DON'T HAVE A SPECIFIC QUESTION. TERRIFIC PRESENTATION. >> THANKS. KIM? >> I WANT TO RESPOND TO THAT BECAUSE I THINK THAT YOU KNOW ANOTHER PLACE YOU MIGHT WANT TO MAKE SURE THAT SEX IS A BIOLOGIC VARIABLE GETS ATTENTION IS IN THE DATA SAFETY MONITORING BOARDS BECAUSE THEY'RE THE ONES WHO WOULD ALLOW THE TRIAL TO BE STOPPED ASK MAY MIGHT WANT TO MAKE SURE THEY MAKE THAT AS A CONSIDERATION. >> DSMBs HAVE A, YES, DIFFERENT PURPOSE THAN DOES THE PI WHO'S DESIGNED THE TRIAL AND THAT'S ANOTHER POTENTIAL PLACE FOR SHARING SABB, I WOULD SAY. I WAS THRILLED TO SEE THAT NEAL TALKED ABOUT THE IRBs. THANK YOU WE WILL HAVE TO EXPAND OUR TEAM ON THE SLIDE TO DSMBs AND IRBEXPZ OTHER FUNDERS. >> [INDISCERNIBLE]. --WITHOUT HEARING--[INDISCERNIBLE]. --MY IRBTALK ABOUT [INDISCERNIBLE] >> IT IS AN ORGANIZATION THAT LIKE I SAID HAS THESE NATIONAL SCIENTIFIC MEETINGS. I CAN GET YOU THE NAME OF IT WHEN IT'S SUPPOSED TO HAPPEN BUT WE WILL HAVE A TALK OR POSTER OR SOMETHING LIKE THAT THEA ONE OF THEM BUT IT WOULD BE BE A GREAT THING FOR YOU AND OTHERS TO TALK AND SPEAK TOO. >> I THINK I KNOW WHO YOU ARE TALKING ABOUT. I'M BLOCKING ON THE NAME TOO. THANK YOU EVERYBODY AND THANK YOU EVERYBODY AROUND THE TABLE ON THE PHONE AND VIDEOCAST. THIS CONCLUDES THE PUBLIC SESSION OF THE MEETING SO WE WILL GO AHEAD AND ADJOURN. THANK YOU EVERYONE. [APPLAUSE ]