WELCOME TO THE 38TH NIH ADVISORY COMMITTEE ON RESEARCH AND WOMEN'S HEALTH. 38, THAT'S A LOT OF MEETING. WE'RE SO PLEASED TO HAVE YOU HERE. IN TERMS OF SOME HOUSEKEEPING THINGS, WE WILL /SWHR PEOPLE HON THE PHONE, SO CAN YOU PLEASE USE YOUR MICROPHONES WHEN YOU SPEAK AND IDENTIFY YOURSELF WHEN YOU SPEAK FOR THE TRANSCRIPTIONS, PLEASE. OKAY. I AM GOING TO GO AHEAD AND AND START US OFF WITH INTRODUCTIONS. I'M JANINE CONGRATULALAYTON. NIH DIRECTOR OF RESEARCH FOR WOMEN'S HEALTH. AND TO MY RIGHT IS GUESS WHO. HI, MY NAME IS SUSAN MYER I AM THE EXECUTIVE SECRETARY OF THE ORWH AND I HOPE YOU HAD A GOOD FLIGHT OR GOOD TRAVELS HERE AND SAFE TRAVELS HOME AND I HOPE THAT YOU ENJOY THIS MEETING AND WE ALWAYS WELCOME FEEDBACK AND COMMENTS. SO PLEASE, DON'T HESITATE TO SEND US COMMENTS. WELCOME. >> HI. I'M HIEIDI NELSON AT THE PORTLAND UNIVERSITY IN OREGON >> MARY PALMER, UNCC, CHAPEL HILL. >> SHERRY MCKIE, YALE UNIVERSITY SCHOOL OF MEDICINE. TITUTE OF ENVIRONMENTAL >> APRIL DUNNET, THE /TPHARNATIONAL HEALTH SCIENCES. MIR, UCLA. >> /SKWHREUL /PWHEBGER, UNIVERSITY OF MICHIGAN. JILL BECKER, UNIVERSITY OF MICHIGAN. >> WEISS, MANY NEW JERSEY MEDICAL SCHOOL, RUTGERS UNIVER. >> ANGELA, UNCC CHAP /*EL HILL. >> UNIVERSITY OF COLORADO, MEDICAL CENTER. >> CHONIE REEFER, HEAD OF NUTRITION AND SCIENCE AT PURDUE UNIVERSITY. >> JOHN LEVIPE, UNIVERSITY /OF AVOIDANCE AND THE AVOIDANCE -- WISCONSIN RESEARCH CENTER. >> UNIVERSITY OF PENNSYLVANIA, SCHOOL OF NURSING. >> WHO DO WE HAVE ON THE PHONE? >> JOHN, UNIVERSITY OF MICHIGAN MICHIGAN. >> GREAT, THANK YOU, JOHN. I KNOW JOHN -- DR. WOOD ROOF AND DR. RICE ARE ON THEIR WAY AND ALSO DR. GREEN IS GOING BACK AND FORTH BETWEEN ANOTHER MEETING THAT IS GOING ON AND OUR MEETING SO WE'LL ACKNOWLEDGE THEM AND INTRODUCE THEM WHEN THEY COME. OKAY. SO LET ME REVIEW SOME REMINDERS THAT YOU NEED TO BE AWARE OF. IT IS MY DUTY TO REMIND YOU OF THE CONDUCT REGULATIONS PERTAINING TO SPECIAL GOVERNMENT EMPLOYEES. YOU RECEIVED THESE REGULATIONS AND YOU WILL -- YOU HAVE OR WILL RECEIVE AN UPDATE REMINDER OF PRACTICES. WE CERTAINLY DO APPRECIATE YOUR EFFORTS TO KEEP US INFORMED OF ANY POTENTIAL CONFLICT OF INTEREST PRIOR TO EACH MEETING, AND LET ME ALSO REMIND YOU THAT ACCORDING TO FEDERAL LAW, COMMITTEE MEMBERS MAY NOT ENGAGE IN /TPHANY LOBBYING ACTIVITIES WHILE ATTENDING COMMITTEE MEETINGS OR SPONSORED EVENTS. WE DO HAVE FOLKS, COMMITTEE MEMBERS AND GUESTS ATTENDING HERE WITH US TODAY. ALL MEMBERS ARE BOUND BY THE SPECIAL EMPLOYEES STATEMENT AND WE WOULD ASK THAT YOU FOLLOW THEM. ANY QUESTIONS? EAT. WE HAVE A COUPLE /OF MINUTES BEFORE OUR NEXT AGENDA ITEM, WHICH IS THE NIH DIRECTOR'S REPORT. I WANT TO JUST IDENTIFY MATERIALS IN YOUR FOLDERS. YOU HAVE YOUR AGENDA, THE SEATING CHART, MINUTES FROM THE LAST MEETING, THE ROSTER, AND THE BIOS FROM OUR MEMBERS. AS WELL AS THE CHARTER FOR THE ADVISORY COMMITTEE. IN ADDITION, YOU HAVE THE HAND HANDOUTS, WHICH ARE THE FIVE PRESENTATIONS TODAY. I ALSO WANT /TO IDENTIFY OFFICE OF RESEARCH ON WOMEN'S HEALTH HEALTH STAFF AND CAN YOU ALL STAND SO THE MEMBERS CAN GET TO KNOW YOU? THERE ARE SEVERAL STAFF MEMBERS OVER HERE. SEVERAL OVER HERE AS WELL. AND QUITE A FEW OVER HERE, TOO. SO THANKS VERY MUCH. I KNOW THAT THEY WILL ALL /BE INTERESTED IN MEETING YOU AND CHATTING WITH YOU TODAY SO PLEASE FEEL FREE TO INTERACT WITH ANY OF THEM. WE HAVE ABOUT ONE OR TWO MINUTES BUT I THINK WE HAVE COORDINATING COMMITTEE MEMBERS HERE THAT WE CAN IDENTIFY. CAN YOU ALL STAND UP /SAND MENTION WHICH INSTITUTE YOU'RE FROM? I SEE YOU O'ER THERE. >> INAUDIB[INAUDIBLE] ANY OTHER MEMBERS? OKAY. ALREADY GREAT. WE HAVE A FEW MORE MINUTES, SO I AM GOING TO PULL UP THE RECORD -- REPORT IN A SECOND. WE WANT TO BE READY FOR DR. COLLINS AS SOON AS HE GETS HERE. SO WE'RE NOT GOING TO INITIATE ANY LONG DISCUSSION. WE HAVE SOME EXCITING STOP -- TOPICS COMING UP A/THAPG I AM GOING TO TALK ABOUT IN MY DIRECTOR'S REPORT BUT I WILL GIVE YOU A LITTLE /TPHRAEUF OF THOSE AS WE ARE STANDING BY HERE HERE. AS YOU KNOW, WE WILL HAVE OUR AN ANNUAL INTERDISCIPLINARY RESEARCH INSPIRING SIM /POYMPOSIUM NOVEMBER 6. THE FOCUS THIS /KWRAYEAR, THE THEME IS ON METHODS AND TECHNIQUES, EX EXPANDING THE IM/PABPACT OF HEALTH RESEARCH AND APPLYING THE PERCESPECTIVE. SO THAT WILL BE THE THEME FOR THIS /KWRAYEAR. AND WE HAVE A METHODS AND TECHNIQUES WORKSHOP THAT WAS RECENTLY APPROVED, THAT I CAN SHARE WITH YOU ON OCTOBER 20TH. DR. SUSAN MYER IS LEADING THAT EFFORT AND ACTUALLY SUSAN, WOULD YOU LIKE TO MAKE ONE OR TWO COMMENTS ABOUT THE WORK SHOB -- WORK SHOP? >> SURE. I'D BE GLAD TO. SO WE ARE HOSTING METHODS AND TECHNIQUES FOR INTEGRATING BIOLOGICAL VARIABLES IN PRE PRECLINICAL RESEARCH. WE'RE GOING TO TALK ABOUT THIS AND TOUCH ON TAI LITTLE BIT LATER, BUT I REALLY WANT /TO EMPHASIZE THAT WE HAVE PUT TOGETHER AN AGENDA THAT WILL TOOK YOUR SOCKS OFF. THESE ARE PEOPLE WHO ARE TOP IN THE FIELD. WE WILL TALK ABOUT ACTUAL WAYS TO IN/KRORCORPORATE SEX INTO PRE PRECLINICAL RESEARCH, AND WE HAVE SOME PEOPLE COMING WHO WILL BE ABLE TO TALK ABOUT DOING SEX- SEX-SPECIFIC CELL CULTURE WORK. SO THIS IS THE NITTY /TKPWRE-GRITTY OF HOW TO DO THIS AND I THINK THIS -- THIS -- WHEN WE DID TALK ABOUT VERY EARLY, WHEN DR. COL COLLINS AND CONGRATULALAYTON PUT A PAPER OUT, THERE WAS A CONCERN, WELL, HOW DO WE DO THIS? THIS IS HOW TO DO IT. THIS IS HOW YOU USE STATISTICAL TECHNIQUES. THIS IS HOW YOU IN/KRORCORPORATE IT AND USE IT IN YOUR ANIMAL AND CELL CULTURE STUDIES, WHICH IS STILL KIND OF /AA LITTLE BIT OF AN INSTANT FEEL BUT I THINK IT'S REALLY GOING TO TAKE OFF AFTER THIS. SO OUR HOPE THIS IS WE WILL BE ABLE TO EDUCATE PEOPLE, LET THEM KNOW WHAT IS HAPPENING AND LET THEM KNOW HOW TO DO THIS AND GET THEIR FEEDBACK, TOO,. SO THAT'S WHAT WE HAVE COMING UP UNTIL THE -- OCTOBER 20TH. /HEUBL YOU HAVE AN AGENDA FOR YOU TO HAVE THE MEETING HAS BEEN APPROVED BY HHS, SO WE'RE GOOD TO ADVERTISE. BUT YES, WE'RE LOOKING FORWARD TO THIS. THIS IS VERY, VERY EXCITING FOR US. >> WILL THERE BE AN OPPORTUNITY TO DO THIS AGAIN, BECAUSE OCTOBER 20TH, I'M SURE, IS GOING TO BE HARD FOR US TO SEND PEOPLE ON SO SHORT NOTICE SO CAN WE HAVE IT AGAIN? >> I'M NOT SURE HHS WILL A APPROVE A DUPLICATE MEETING, HOWEVER, WE WILL /BE VIDEO CAST CASTING THE MEETING SO IT WILL BE LIVE AND WILL KEEP IT ARCHIVED. SO IT WILL BE VIEWABLE ONLINE AFTER THE MEETING, AND I'M A ASSUMING THAT WHEN WE GET FEEDBACK AT THE MEETING AND WHEN WE GET INTO MORE OF THE POLICIES POLICIES, DEVELOPMENT, WHEN I WHEL TALK ABOUT THAT IN LITTLE BIT DURING TODAY, I'M SURE AT THE END OF ALL OF THIS, WE MIGHT HAVE HAVE TO HAVE ANOTHER MEETING. I'M NOT SURE WE'RE GOING TO GET EVERYTHING IRONED OUT IN ONE DAY OR IN ONE QUARTER OR EVEN IN ONE YEAR SO IT COULD TAKE TIME AND IT TAKES FEEDBACK FROM EVERYONE TO DO THIS TYPE OF WORK. SO WE RELY ON YOUR FEEDBACK AND WE ALSO WANT /TO MAKE SURE THAT WE IN/KRORCORPORATE EVERYTHING AND -- UNTIL WE GET IT RIGHT. >> SUSAN, ARE WE GOING TO GET THIS IN AN /AE-MAIL SO WE CAN PASS IT AROUND? >> YES, YOU WILL. WE JUST GOT APPROVAL FROM HHS, AND WE'RE TECHNICAL LY NOT SUPPOSED TO BE ADVERTISING THINGS THAT WE HAVEN'T GOT A APPROVED. SO WE HAVEN'T BEEN ABLE TO SAY MUCH ABOUT IT. BUT YES, WE'LL BE DO A COMMUNICATIONS PLAN OVER AROUND IT AND WE WILL /BE ADVERTISING IT IT. IT'S AN OPEN MEETING, AND IT'S AVAILABLE TO EVERYONE IT WILL BE LIVE BROADCAST, SO THERE IS NOT OPPORTUNITY TO JOIN IN EVEN IF YOU CAN'T JOINT WHOLE THING, TO HAVE STUDENTS POSTDOCS POSTDOCS, INTERESTED PEOPLE, VIEW AND IT WILL BE ARCHIVED. >> I ALSO WANT /TO MAKE /SHAOUSURE I RECOGNIZE DR. JIM ANDERSON. >> GOOD MORNING. >> DELIGHTED TO HAVE HIM JOIN US HERE THIS MORNING AS WELL. >> JUST LOOKING FIRE SIGNAL OKAY. FIRE SIGNAL THERE. WHAT ELSE CAN I TELL YOU ABOUT? I WILL REMIND YOU THAT WE'RE ALMOST ON THE HALF WWAY MARK FOR IMPLEMENTATION OF THE NIH STRATEGIC PLAN FOR WOMEN'S HEALTH RESEARCH. IN 2015, IT WILL BE OUR 25TH YEAR AT THE OFFICE BILLION AND IT WILL BE THE HALF WWAY MARK FOR IMPLEMENTATION OF THE PLAN. SO JUST LET ME PUT THAT IN THE BACK OF YOUR MIND. I ALSO WANT /TO ENCOURAGE YOU TODAY TO SHARE YOUR THOUGHTS ABOUT ANY ASPECTS OF OR /W-FPWH'S ACTIVITIES. THAT'S HELPFUL TO ME TO HEAR YOUR THOUGHTS, AS WELL AS NIH- NIH-WIDE WELCOME'S HEALTH RESEARCH. THE APPROACH THAT WE'RE TAKING TO APPLYING A HEALTH AND GENDER PERCESPECTIVE TO RESEARCH. WE ARE REALLY ARE LOOKING FORWARD TO HEARING YOUR THOUGHTS THOUGHTS. OKAY. AND OUR ESTEEMED NIH DOLOR HAS JOINED US. DR. COLLINS, WE'RE DELIGHTED TO HAVE YOU AND I WILL GO AHEAD AND GIVE A FEW LARKS. WOULD YOU LIKE TO SPEAK FROM THE TABLE? >> RIGHT YEAH. >> OKAY, GREAT, WONDERFUL. SO IT'S MY PLEASURE TO INTRODUCE DR. FRANCIS ALCOHOLINS, OUR NIH DIRECTOR, TO THE GROUP HERE, THE ADVISORY COMMITTEE ON WOMEN'S HEALTH. I WANT TO HIGHLIGHT A FEW THINGS MANY OF YOU KNOW DR. COLLIN'S MAJOR ACCOMPLISHMENTS AS /AA SCIENTIST, AS /AA LEADER, ATS /SKWHR-RB HAS AN ADMINISTRATOR. I AM GOING TO HIGHLIGHT A COUPLE THAT I WANT /TED TO BRING TO YOUR ATTENTION. /TKHR-FRPLT COLLINS HAS BEEN /SPRUPBL IN LEADING AN NEGOTIATE BE AND BROUGHT NEWUROSCIENTIST AND OTHERS TOGETHER TO ESTABLISH A 12-YEAR SCIENTIFIC VISION FOR NEWUROSCIENCE AND WE ARE PARTICULARLY EXCITED ABOUT THAT EFFORT AND WE'RE ABLE TO SUPPORT THAT FOR THE FIRST TIME THIS YEAR. IN ADDITION, HE IS LEADING IN PARTNERSHIP WITH PUBLIC AND PRIVATE ENTITIES, THE ACCEL ACCELERATING MEDICINE'S PARTNER PARTNERSHIP, AND WE'RE ALL EXCITED ABOUT THAT. IN PARTICULAR, THAT ACTIVITY IS BEGINNING PILOT IN SEVERAL DISEASES OF PARTICULAR RELEVANCE TO WOMEN'S HEALTH, INCLUDNG AL ALZHEIMER'S, AS WELL AS AUTO AUTOIMMUNE DISORDERS AND ARTHRITIS SO WE'RE EXCITED ABOUT THAT, TOO,. DR. COLLINS HAS ALSO BROUGHT AN EMPHASIS ON ISSUES OF THE SCIENTIFIC WORK FORCE /SAND DIVERSITY, BOTH THE FUTURE OF THE SCIENTIFIC WORK FORCE /SAND TRYING TO ENSURE THAT WE ARE ABLE TO MOVE FORWARD AND TAKE ADVANTAGE OF THE /PHAEAMAZING TECHNOLOGICAL AND SCIENTIFIC ADVANCES THAT ARE HERE TODAY. WE HAVE EXTREME CHALLENGES IN OUR ENVIRONMENT. BUT THAT DOESN'T MEAN WE'RE NOT UP FOR THE CHALLENGE. IT MEANS HE'S TAKEN THAT ON WITH WITH, I WOULD SAY, IN /AA WAY THAT HASN'T BEEN TAKEN ON BEFORE IN FACT, DR. COLLINS BROUGHT ON DR. HANNAH VALENTINE AND ESTABLISHED A NEW POSITION HERE, CHIEF OFFICER FOR SCIENTIFIC WORK FORCE DIVERSITY. SO I WILL STOP WITH THOSE FEW KEY THINGS AND I KNOW ALL OF YOU WILL JOIN ME IN WELCOMING DR. COLLINS TO HIS FIRST VISIT TO THE ADVISORY COMMITTEE ON RESEARCH AND WOMEN'S HEALTH. THANK YOU SO MUCH FOR BEING HERE HERE. /PHRA [APPLAUSE] >> THANK YOU. IT'S A PLEASURE TO BE ABLE TO COME AND SPEND A FEW MINUTES WITH ALL OF YOU. I WANT TO EXPRESS MY THANKS TO ALL OF YOU FOR THE HARD WORK YOU DO AS PART OF THIS ADVISORY COMMITTEE BECAUSE I KNOW EVERYBODY HAS LOTS OF THINGS ON THEIR PLATE AND LOTS OF ACTIVITIES THAT REQUIRE A LOT OF YOUR TIME AND WE APPRECIATE YOUR THEY HAD INDICATION TO THIS EFFORT, BETTER TO WHICH WE REWARD YOU WITH TAP WATER. LAUGHT[LAUGHTER] SORRY ABOUT THAT. SORT OF THE WAY THINGS HAVE BEEN GOING. REALLY, YOUR ADVISORY CONTRIBUTIONS TO WHAT JANINE AND THE REST OF HER TEAM AT OR WH ARE DOING IS CRITICAL TO MAKING SURE THAT WE'RE MAKING THE MOST SCIENTIFIC OPPORTUNITIES THAT ARE ALL AROUND US. NOT NECESSARILY AT THE EASIEST TIME FOR NIH. WE HAVE THIS PARADOXICAL SITUATION OF FANTASTIC SCIENTIFIC OPPORTUNITIES AND THE TOUGHEST RESOURCE CON/STRAEPBTS THAT ANYBODY CAN CAN REMEMBER, WHICH MEANS WE HAVE TO REALLY BE EVEN MORE CREATIVE IN FINDING OTHER WAYS TO BUILD PARTNERSHIPS PARTNERSHIPS. THANKS FOR MENTIONING THE ACCEL ACCELERATING PARTNERSHIP, WHICH IS ONE EXAMPLE WE'VE TRIED /TO HELP MOVE THE BALL ALONG BY SHARING THE COSTS WITH OTHER EN ENTITIES THAT ARE WILLING TO COME ALONGSIDE WITH US. IN THAT CASE, TEN PHARMACEUTICAL COMPANIES. BUT ON TOP OF ALL THAT, I WOULD SAY THE DOMINANT FEELING I HAVE IS AND IS THIS IS A REMARKABLE TIME TO BE INVOLVED IN BIO BIOMEDICAL RESEARCH AND EVEN THOUGH I WISH WE COULD GO BAK THERE AND I WISH THERE WAS MORE SCIENCE THAT WE CAN SUPPORT INSTEAD OF TURNING IT AWAY, NOW WITH OUR SUCCESS RATES DOWN TO ABOUT 17%, THERE ARE GREAT THINGS THAT WE CAN DO EVEN AS WE /AFADVOCATE OUR CASE FOR WHY WE NEED TO TURN THIS CORNER AFTER A TEN-YEAR DECLINE IN NIH SUPPORT FROM THE CONGRESS AND GET IT BACK ON A STABLE TRA TRA/SKWREBJECTORY THAT WOULD NURTURE ALL OF THE GREAT IDEAS AND ALL OF THE GREAT SCIENTISTS THAT ARE OUT THERE LOOKING TO US TO GET THEM OFF /THE GROUND SO IT IS VERY MUCH APPRECIATED THAT YOU ARE HELPING US THROUGH THIS PARADOXICAL TIME. I THOUGHT I WOULD SAY A FEW WORDS, BECAUSE JANIN AND I HAVE BEEN INVOLVED IN /THIS OVER THE LAST FEW MONTHS, ABOUT THE EMPHASIS THAT WE FEEL NOW REALLY NEEDS TO BE BROUGHT TO BEAR ON UTILIZATION, BOTH ACCESS AND PRE PRECLINICAL RESEARCH. I THINK IT'S FAIR TO SAY BACK TO THE NIH REVITALIZEATION ACT OF 1993, WE'VE DINE LOT TO INCREASE THE /PHARPGS-WOMEN IN CLINICAL STUDIES AND THAT'S A SUCCESS STORY THAT I THINK WE SHOULD BOTH BE PROUD OF AND SAY WE'RE NOT DONE YET AND THERE IS CERTAINLY AREAS THAT CONTINUE PERHAPS TO NEED ATTENTION IN THAT REGARD CERTAINLY CHOREOGRAPHER /KRAURD DISEASE, FOR INSTANCE IS ONE WE'RE CONCERNED ABOUT IN TERMS OF WHETHER WE ARE DOING THE RIGHT THING FOR WOMEN WHO INTEND TO HAVE WHAT DIFFERENT MAN MANIFESTATIONS OF HEART DISEASE BUT I THINK AN AREA THAT REALLY HADN'T GOTTEN THE ATTENTION IT DESERVES IN /TPHANY SIGNIFICANT WAY, DESPITE SOME LONELY VOICE OUT THERE SPEAKING ABOUT IT, IS /THE NEED TO INCLUDE BOTH SEX /TPWH-Z PRECLINICAL STUDIES. JANINE BROUGHT THIS TO MY ATTENTION SHORTLY AFTER SHE WAS NAMED AS THE DIRECTOR, AND IN FACT SHE AND I HAD STARTED DOWN THE PATH OF DRAFTING UP A COMMENTARY ABOUT THIS TRYING TO DRAW ATTENTION TO THIS AND THEN THE ATTENTION BEGAN TO ESCALATE A BIT AS OTHER FOLKS PAID MORE AND MORE ATTENTION TO THE ISSUE. AND AS A RESULT OF THAT, WHICH WAS ACTUALLY KIND OF FOR TIGHT TIGHTUOUS BECAUSE TAALLOWED US TO GET A LOT MORE VISIBILITY. I THINK WE'RE NOW IN A VERY WILL GO PLACE. AND THAT WAS MANIFEST OF COURSE, YESTERDAY, BY THIS ANNOUNCEMENT OF OVER $10 MILLION IN SUPPLEMENTAL FUNDING TO SUPER SUPERCHARGE THE RESEARCH OF MORE THAN 80 GRANTEES TO EXPLORE THE EFFECTS OF SEX IN PRECLINICAL STUDIES AND CLINICAL STUDIES AS WELL AND THIS, I THINK, IS A REAL SIGN OF JUST HOW SERIOUS WE ARE NOT ONLY ABOUT EXHORTING /SHREUPBLGZ WHO ARE /TKHOG LARCH IN PRECLINICAL STUDIES, BUT GIVING US -- GIVING THEM ADDITIONAL RESOURCES TO SEE WHAT CAN BE DONE IT WOULD NICE IF THE "NEW YORK TIMES" PICKED UP ON THIS AND WRITING ABOUT IT. THAT AGAIN IS ANOTHER WAY OF DRAWING ATTENTION TO THE ISSUE. SO THESE SUPPLEMENTS ARE GOING TO /EBEXPAND OUR EVIDENCE BASE AND MOVE US TOWARD THE PARADIGM WHERE IT IS EXPECTED THAT SEX IS CONSIDERED A BIOLOGICAL VARIANCE FROM THE VERY START OF THE DESIGN OF /AA PRECLINICAL STUDY AND OF COURSE I AM PARTICULARLY REFERRING TO ANIMALS BUT THIS A APPLY TO CELL-BASED RESEARCH ARE EVEN LESS LIKELY I THINK IN THE PAST TO AND THE SEX OF THE CELLS THAT WE ARE -- THEY ARE WORKING WITH AND THAT POTENTIALLY IS A MISSED OPPORTUNITY TO LEARN REALLY IMPORTANT ISSUES ABOUT BIOLOGY. SO I AM PROUD THAT WE'VE GOTTEN TO THIS POINT, BUT WE HAVE A LONG WAY TO GO IN TERMS OF REALLY GETTING THIS KIND OF ATTENTION TO THE ISSUE. BUT WE'RE ON A ROLL HERE. SO WHAT WILL WE GOING TO DO ABOUT THAT TO /TRAOTRY TO /EBGS EFFORT? BY THE WAY, WE DID A SURVEY JUST AS /AA SAMPLE. IT'S ACTUALLY NOT EASY TO GO THROUGH OUR ENTIRE PORT /TPOFOLIO AND FIND OUT /OF PEOPLE WHO ARE DOING PRECLINICAL ANIMAL MODEL RESEARCH, HOW MANY OF THEM ARE USING MALES AND FEMALES. IT'S NOT ONE /OF THOSE THINGS YOU PUSH A BUTTON AND THE ANSWER COMES OUT. SO WE DID A STATISTICAL SAMPLE THOSE AND THEN BY HAND PEOPLE IN SALLY ROCKY'S AS OF WENT THROUGH AND LOOKED TO SEE. IT WAS PRETTY TROUBLING, I MUST SAY. NOW A LOT OF THE TIME YOU JUST COULDN'T TELL FROM THE WAY THAT THE GRAND -- GRANT WAS WRITTEN WHETHER THERE WAS GOING TO BE INVOLVEMENT OF MALE AND FEMALE ANIMALS. BUT THERE WERE A FAIR NUMBER WHERE THEY WERE WORKING ONLY WITH MALES. AND THE ONES THAT I THINK WERE REASONABLY WELL-DESIGNED IN TERMS OF HAVING MALES AND FEMALES AND THINKING ABOUT THE POSSIBILITIES THAT THERE MIGHT BE BIOLOGICAL LY IMPORTANT DIFFERENCES WERE A SMALL MINORITY. SO WE HAVE A LOT /OF WORK TO DO HERE /TO RAISE THE CONSCIOUSNESS OF THE COMMUNITY TO THE IMPORTANCE OF THIS ISSUE. THERE ARE WAYS IN WHICH WE ARE TRYING THOBRING THAT TO ATTENTION. TRAINING MODULES, LIVE WEBINARS THAT ARE BEING SET UP /SAND AN RFI RELEASED SEPTEMBER 11 WITH A RESPONSE DATE OF OCTOBER 13 AND I HOPE WE GET A WILL THE OF RESPONSES. NOT EVERYBODY IS HAPPY WITH THE WAY THIS IS GOING I THINK THERE ARE RESEARCH ER WHO ARE CONCERNED THAT THIS IS ONE MORE EFFORT BY NIH TO TELL THEM WHAT TO DO. WELL /SKWHR-RGS /KHAE. AND THEY'RE -- THERE ARE ALSO CONCERNS THAT THIS WILL BASICALLY INCREASE THE COST OR DOUBLE IT BY INSISTING THAT YOU INCLUDE MALES AND FEMALES AND HAVE SUFFICIENT NUMBERS TO BE ABLE TO ANALYZE THEM SEPARATELY. I THINK THAT IS AN OVERSTATEMENT OF WHAT WE'RE ASKING FOR. YOU DO NOT WANT /TO MISS THE FACT THAT THERE IS A SUBSTANTIAL DIFFERENCE BETWEEN FEMALES AND MALES IN AN ANIMAL MODEL STUDY. BUT WHAT THAT MEANS AS FAR AS THE /POEPOWER OF YOUR ANALYSIS BASICALLY COMES DOWN TO HOW SMALL A DIFFERENCE ARE YOU WILLING TO MISS? OBVIOUSLY, VERY SMALL DIFFERENCE DIFFERENCES ARE GOING TO BE VERY HARD TO DOCUMENT WITH VERY LARGE NUMBERS OF ANIMALS AND THERE IS GOING TO BE /AA BALANCE BETWEEN COST AND SCIENTIFIC BENEFIT BUT MY GOODNESS. I THINK FOR VERY SIGNIFICANT DIFFERENCES IT IS QUITE POSSIBLE WITH THE NUMBER OF ANIMALS PEOPLE ARE ALREADY USING THEY'RE ALL MALES IF THEY SIMPLY DID MALES OR FEMALES, YOU WOULD DISCOVER THOSE DIFFERENCES WITHOUT AG -- HAVING THOADD /TKHEURBL ANIMALS. I DON'T ACCEPT THE IDEA THAT THIS REQUEST IS GOING TO GREATLY INCREASE THE COST OF DOING AN ANIMAL RESEARCH. I DO THINK WE HAVE TO THINK CARE CAREFULLY ABOUT EACH STUDY IN TERMS OF EXACTLY WHAT IS THE POWER ANALYSIS AND WHAT ARE THE EXPECTATIONS ABOUT WHAT DEGREE OF DIFFERENCES BETWEEN MALES AND FEMALES YOU ARE ACTUALLY GOING TO BE ABLE TO DETERMINE AND RECOGNIZE THAT UPFRONT. A LOT /OF THIS FRANKLIN IS ABOUT GOOD EXPERIMENTAL DESIGN THINGS THAT WE ARE /AFADVOCATING ABOUT IN TERMS OF RE/PRAOPRODUCIBILITY, PRECLINICAL EXPERIMENTS USING AN ANIMAL MODELS BECAUSE THAT'S A LARGER ISSUE THAT INCLUDES A NUMBER OF OTHER AREAS ABOUT EXPERIMENTAL DESIGN THAT WE'RE CONCERNED ABOUT BECAUSE A LOT OF ANIMAL MODEL STUDIES OF THERAPEUTIC INTERVENTIONS HAVE TURNED HOW THE NOT TO BE READILY RE/PRAOPRODUCIBLE IN THE HANDS OF OTHER LABS AND WE HAVE TO FIGURE OUT WHY THAT IS AND WHAT TO DO ABOUT IT. OCCASIONALLY SUPPOSE THAT MIGHT BE ON THIS VERY BASIS THAT ONE LABS USED A MIX OF FEMALES AND MALES AND WOULDN'T SURPRISE YOU. SO WE'RE IN /THIS MIX -- I THINK WE'RE TALKING A LOT TO THE COMMUNITY. THE R /TP-FPFI WILL HELP GET ADDITIONAL IN/PPUT AND A WORKSHOP. WE DON'T WANT /TO RUSH INTO THIS BUT WE ARE SERIOUS ABOUT ACTUALLY IMPLEMENTING CHANGE IN A WAY THAT IS GOING TO ADDRESS AN ISSUE THAT HAS BEEN NEGLECTED AND I AM PERSONALLY VERY DED DEDICATED TO THAT. JOURNALS ARE ALSO PART OF THIS. WE WOULD WANT /TO SEE AN /EUPB INCREASING NUMBER OF JOURNALS IN ORDER TO ACCEPT A MANUSCRIPT DESCRIBING AN ANIMAL MODEL STUDY STUDY. TO HAVE THE AUTHORS EXPLAIN WHAT WAS THEIR DECISION ABOUT MALES AND FEMALES AND BE VERY EX EX/PHREEXPLICIT ABOUT WHY THEY DESIGNED IT THAT WAY AND WHAT NUMBERS THEY ACTUALLY USED BECAUSE SOMETIMES YOU CAN'T TELL AND THAT'S DE DEPRIVING ALL OF US OF KNOWLEDGE WE'D LIKE TO HAVE. SO, I /TKPWGUESS I WANTED MOSTLY JUST TO MENTION THOSE ISSUES AND AGAIN TO DOCUMENT MY OWN VERY SINCERE EFFORT THIER TRY TO BE SURE THAT WE ADDRESS THIS ISSUE. MANY OF YOU AROUND /THE TABLE HAVE WORKED ON RESEARCH ON SEX DIFFERENCES, SO I THINK I'M PREACHING TO THE CHOIR HERE. AND YOU ARE HELPING US ALREADY. I HOPE YOU WILL CONTINUE TO HELP BY SHARING YOUR EXPERTISE AS WE THREE TO ANYTHING HOW THE HOW IT WORKINGS TO IMPLEMENT THESE INTENTIONS. BUT WE ARE GOING TO IMPLEMENT THEM. THERE WILL BE NO CHANGE IN THE OCTOBER SORT OF CYCLE BECAUSE WE WANT TO BE SURE WE HAVE OUR GUIDELINES FOR GRANTEES. BUT PRETTY SOON WE WILL WANT TO HAVE THOSE OUT THERE. WE DON'T WANT /TO SURPRISE THEME - PEOPLE OR HAVE THEM CAUGHT AT THE POINT OF REVIEW WITHOUT HAVING HAD CLEAR INSTRUCTIONS ABOUT WHAT THEY EXPECTED. AND SO IT TAKES TIME PUT THOSE IN PLACE. WE'RE WE'LL GET THERE AND I THINK SCIENCE WILL BE BETTER FOR US AND WHAT WE NEED TO KNOW ABOUT THE DIFFERENCES BETWEEN MALES AND FEMALES IN ANIMAL MODELS, WHICH MAY VERY WELL HAVE SIGNIFICANT ITCH INDICATION FORS HUMAN MEDICINE. WE'RE GOING TO FIND THOSE THINGS OUT. SO THANK YOU ALL FOR THE CHANCE TO BE HERE. I'LL BE GLAD TO ANSWER A FEW QUESTIONS, IF YOU HAVE THEM, BEFORE I HAVE TO DASH YOU OFF TO THE NEXT THING, WHICH IS PROBABLY GOING TO BE ABOUT EBOWL EBOWLA, BECAUSE THAT'S MOSTLY WHAT I AM DEALING WITH THESE DAYS. >> THANK YOU SO MUCH FOR YOUR THOUGHTS. FIRST DR. ^WEAVER AND THEN DR. . ^GREEN? >> SO I AM DEPUTY DROPPER OF THE INDIANA SCIENCES INSTITUTE AND OUR LAST ANNUAL MEETING I ORGANIZED THIS BREAKOUT SESSION BETWEEN LOCAL HOSPITALS AND RESEARCH INPUTS TO TALK ABOUT HOW CAN WE PARTNER FOR ADVANCING RESEARCH TOGETHER? AND I RAISED A LOT /OF THESE STATISTICS BUT JANINE SHARED THEM ON PHONE CALLS ABOUT HOW BEHIND WE ARE IN STILL STUDYING WOMEN IN THESE CLINICAL TRIALS AND THAT SURPRISED ME, SINCE AT NIH, YOU'RE ASKED TO JUSTIFY WHY YOU DON'T. AND THEIR ANSWER AT THE HOSPITALS WAS THAT IF THERE WAS ANYTHING THAT WOULD PUT A PREGNANT WOMAN AT RISK, THEY WON'T INCUR THE LIABILITY AND SO THEY WON'T TOUCH THAT WHOLE PERIOD OF /AA WOMAN'S LIFE IF THERE COULD BE ANY RISK. HOW DO WE RESPOND TO /TTHAT? >> I'VE HEARD THAT IN SOME IN INSTANCES AS WELL. THAT'S CLEARLY NOT ASSESSED -- THERE ARE CERTAINLY WAYS OF DETERMINING WHETHER SOMEBODY IS PREGNANT OR NOT THESE DAYS SO OBVIOUSLY CONSIDER THE GREATEST IF IT'S A PHASE TWO OR A PHASE THREE TRIAL OF A NEW SMALL MOLECULE THAT MIGHT HAVE COMPLICATIONS AND THE DRUG COMPANY DOESN'T WANT /TO TAKE ANY KIND OF A CHANCE ABOUT THAT. OF COURSE, LOTS AND LOTS OF CLINICAL /TRAOEUTRIALS WOULD NOT BE EXPECTED TO CARRY MUCH OF THAT RISK. FENE YOU WEREN'T CERTAIN OF THE PREGNANCY STATUS. BUT YEAH, THOSE IDEAS I /TKPWGUESS CREEP INTO THE SORT OF THING OF TRIAL DESIGN PEOPLE AND ESPECIALLY WITH LAWYERS IN THE ROOM CREEPS IN MORE QUICKLY IN THE LIABILITY ISSUE. BUT WE SHOULDN'T -- WE SHOULD BE PUSHING BACK REALLY HARD ON THAT. >> I HADN'T THOUGHT ABOUT IT BEFORE BUT EDUCATION. I AGREE WITH YOU. >> THERE CERTAINLY ARE A VARIETY OF STRATEGIES THAT CAN BE USED REGARDING PREGNANT WOMEN WOMEN. THE /PWOPBOTTOM LINE IS WOMEN GET PREGNANT AND PREGNANT WOMEN GET SICK. WE, AS FIPHYSICIANS HAVE A THIN SPACE TO MAKE CLINICAL DECISIONS AND SO THERE ARE STRATEGIES, PRACTICE-BASED RESEARCH AND A VARIETY OF OTHER STRATEGIES THAT CAN BE USED IF WE ARE INTENTION INTENTIONAL ABOUT LEARNING ABOUT THIS AREA. IN GENERAL, WE ARE DOING A GREAT JOB, I WOULD SAY. OF COURSE, WE ALWAYS HAVE ROOM FOR IMPROVEMENT IN TERMS OF INCLUDING WOMEN IN CLINICAL RESEARCH AND TRIALS BUT OVER 50% OF YOUR PARTICIPANTS BOTH ARE TRIAL -- TRIALS AND RESEARCH ARE WOMEN. BUT THIS ISSUE OF PARTICULAR SUB SUBSETS OF WOMEN AND CLINICALLY RELEVANT IMPORTANT AREAS REMAIN. >> RIGHT. >> DR. ^GREEN? DO YOU WANT TO MAKE A COMMENT? >> I'M THE VICE PRESIDENT AND DEAN AT THE UNIVERSITY /OF MICHIGAN AND PROFESSOR OF MEDICINE AT THE INSTITUTE. -- INSTITUTION. >> HOPEFUL. LAUGHT[LAUGHTER] >> SO THANK YOU FOR YOUR COMMENTS. AND I WANT TO GO BACK ON BOTH OF THESE COMMENTS. DISPROPORTIONATE LY, WOMEN OF COLOR ARE THE ONES WHO GET SICK. AND THEY DO NOT LIVE HEALTHIER LOSES AND TOLUC TO HEAR A LITTLE BIT MORE ABOUT SOME INITIATIVES THAT YOU MIGHT BE THINKING THAT FOCUS ON DISPARITIES AND THEN ALSO, ON THE DIS DISPARITIES THAT EXIST AS WELL AS IN THE LARGER SCIENTIFIC WORK FORCE. YOU MADE A COMMENT ABOUT HIRING HANNAH VALENTINE AND FUNDING, BUT I'D LIKE TO HEAR IN SOME OTHER INITIATIVES THAT GO BEYOND JUST THE PEER REVIEW. SORT OF KEPT TRACK SOME OF THE THINGS YOU ARE DOING BUT I'D LIKE TO HEAR MORE ABOUT THAT. >> I'D BE GLAD TO. FIRST OF ALL, IN TERMS OF HEALTH DISPARITY RESEARCH, A VERY HIGH PRIORITY ACROSS ALL OF THE INSTITUTES AT NIH. YOU MAY KNOW THAT YVONNE MADDUX WAS ASKED MY -- BY TO STEP IN AS THE ACTING DIRECTOR OF NIM HD AND SHE'S -- SHE'S BROUGHT A LOT OF ENERGY TO THINKING THROUGH WHERE ARE WE WITH THIS PORT FOAL FOALIO AND HOW CAN WE BE EFFECT EFFECTIVE IN IDENTIFYING THOSE PRIORITIES AND I MEET REGULARLY WITH I /SHRO*PB. WITH HER ALSO IN THE PROCESS OF A SEARCH FOR THE PERMANENT DIRECTOR OF NIM HD -- HD, A SEARCH COMMITTEE BEING LED BY GIVEENS AND EXCITE POTENTIAL CANDIDATES. I WILL ASSURE YOU THAT ALL THE INSTITUTES ARE ENGAGED IN /THIS AND IN THEIR OWN SORT OF DOMAINS AND YOU POINT OUT RIGHT LY THAT THIS IS AN AREA THAT DESPERATELY NEEDS BETTER UNDERSTANDING BUT NOT JUST UNDERSTANDING OF FACTORS BUT ACTUALLY DEVELOPMENT OF INTERVENTIONS THAT CHANGE THIS. WE KNOW WHAT A LOT OOF THE FACTOR ARE THAT ARE RESPONSIBLE FOR HEALTH DISPARITIES. WE HAVE RELATIVELY LITTLE CONFIDENT IDEAS ABOUT WHAT TO DO ABOUT THOSE THAT COULD BE IMPLEMENTED READILY THROUGH HEALTHCARE SYSTEMS AND WE NEED MORE THAT HAVE KIND OF INFORMATION. I AM ON THE BOARD OF GOVERNORS PECORI, AND YOU PROBABLY KNOW HEALTH DISPARITIES IS ALSO ONE OF THEIR HIGHEST PRIORITIES. AND THAT'S GREAT BECAUSE THIS IS A NEW ENTRY ON THE SCENE WITH NOW ROUGHLY A HALF BILLION DOLLAR A YEAR BUDGET, AND IT'S A CHANCE WITHIN NIH IN SUCH A SQUEEZE TO HAVE AN ADDITIONAL FUNDS TO BE ABLE TO SUPPORT SOME OF THOSE STUDIES AND WE JUST ARE STUDYING DOWN THE PATH OF DOING JOINTLY AN EFFORT TO LOOK AT HYPERTENSION IN UNDERREPRESENTED GROUPS AND THAT WILL BE PARTICULARLY, I THINK, RELEVANT FOR WOMEN, FOR MINORITY COMMUNITIES WITH HYPER/THEPBGS -- HYPERTENSION. THIS IS A PARTNERSHIP WHERE PE PECOREI HAS FUNDED AND NIH HAS A LOT /OF EXPERIENCE IN TERMS OF SETTING UP THE COMPETITION. WE'RE GOING TO DO THIS TOGETHER AND TRYING TO MAKE PARTNERSHIPS WORK. IN TERMS HISTORY /WHORG FORCE, YEAH, HAD CLEARLY, THIS IS AN AREA WHERE NIH HAS BEEN INTERESTED AND INVOLVED AND MOTE MOTIVATED TO /TRAOTRY TO ADDRESS THE NEED TO HAVE A WORK FORCE THAT IS MORE BROADLY REPRESENTATIVE OF THE COUNTRY. BUT WE HAVE NOT BEEN VERY SUCCESSFUL FRANKLY OVER THESE MANY DECADE IT, DESPITE A LOT OF PROGRAMS THAT WERE PUT IN PLACE. TO BE HONEST, I THINK A LOT OF THOSE PROGRAMS ARE HARD, REALLY, THO/SHA*ES IN TERMS OF WHAT THEIR EFFECT /KWREUIVENESS HAS BEEN. WHEN I ASK ABOUT THOSE, I GET /A ANECDOTES. I DON'T NECESSARILY GET DATA, THE SORT OF -- SORT I WOULD WANT WANT. WE HAVE-IN PLACE A VERY GOOD TRACKING SYSTEM WITH THOSE VARIOUS TRAINING PROGRAMS THAT WERE DESIGNED TO /RECRUIT AND RETAIN BEEM FROM UNDER/WREPD BACKGROUND AND WE CLEARLY NEED TO FIX THAT WITH WHAT WE DO GOING FORWARD. BUT THE QUESTION IS VERY TIMELY BECAUSE IN THE VERY NEAR FUTURE, WE ARE GOING TO ANNOUNCE THE SUCCESSFUL GRANTEES FOR /AA BOLD NEW PROGRAM, WHICH IS SPECIFICALLY FOCUSED ON TRYING TO DIVERSIFY THE WORK FORCE. AND THIS PROGRAM ACTUALLY THESE PARTS IT. ONE IS CALLED BUILD. WHICH IS AIM ING ING TO PROVIDE RESOURCE HAS TO INSTITUTIONS TO TRAIN A VERY SIGNIFICANT NUMBER OF INDIVIDUALS FROM UNDER UNDERREPRESENTED GROUPS. UNDERGRADUATE, I AM TALKING ABOUT, BUT WHO DO NOT THEMSELVES REPRESENT RESEARCH-INTENSIVE UNIVERSITIES. WE ASKED THEM TO PARTNER WITH THE UNIVERSITIES THAT DID HAVE SUCH RESEARCH CAPABILITIES,, SO THAT SUCH INDIVIDUALS WOULD HAVE THE OPPORTUNITIES FOR REALLY SIGNIFICANT RESEARCH EXPERIENCE, AS OPPOSED TO READING ABOUT IT IN THE CLASSROOM BECAUSE THAT SEEMS TO BE SUCH A DEFINING MOMENT IN TERMS OF CATCHING THE IMAGINATION OF INDIVIDUALS WHO SAY YES, THIS IS WHAT I WANT TO DO. ALONG WITH THAT, WE WILL /BE FUNDING A NATIONAL RESEARCH MENT MENTORING NETWORK, WHICH IS AIMED TO FILL WHAT IS CLEARLY A GAP AND I THINK THERE ARE STUDIES THAT HAVE POINTED THAT OUT AS WELL AS OTHER THINGS THAT WE'VE DONE -- A GAP IN PROVIDING THAT KIND OF MENT /OORING FOR /SHREUPBLGZ WHO HIT /HROUF SPOTS SPOTS, AS MOST TRAINEES DO, BUT WHO MAY HAVE NOT A MENT /OOR THAT LOOKS LIKE THEM. WE NEED TO MAKE MORE OF AN ACTUAL NETWORK AND THAT IS GOING TO BE /AA BOLD, A NEW ADDITION TO THIS AND THEN TRY TO DO THE MATCHUP BETWEEN UNDERGRADUATES, /W-RGS GRADUATE STUDENTS, POST POSTDOCS ARE MENT /OOR WHOSE HAVE SIMILAR EXPERIENCES AND WHO CAN HELP THEM WHEN THINGS GET A LITTLE TOUGH BECAUSE THEY TEND TO DO THAT, ESPECIALLY AT TRANSITIONS BETWEEN ONE DAYS AND THE NEXT. AND THEN THERE IS GOING TO BE A COORD NATING AND EVALUATING CENTER OR WHERE THIS TIME WE ARE GOING TO SET THIS UP /SAND WE CAN MAKE CHANGES AS NECESSARY. JUST AS /AA PRETTY BIG DEVELOPMENT AND SORT OF APPROACH TO THIS. IT DOESN'T MEAN WE'RE NOT GOING TO CONTINUE TO DO THE OTHER THINGS THAT WE'RE DOING BUT WE'RE GOING TO MAKE /SHAOSURE THAT WE'RE MONITORING THEIR EFFECTIVE EFFECTIVENESS. ALL OF THIS WITH HANNAH VALEN VALEN-TYPE NOW HAVING ARRIVED, I HOPE REFLECT THE SERIOUSNESS THAT MYSELF AND ALL OF THE OTHER INSTITUTE DIRECTORS ARE NOW /A APPROACHING THIS PROBLEM. AND WE THINK WE HAVE TOOLS NOW THAT MAYBE DIDN'T EXIST BEFORE TO /TRAOTRY TO ACCOMPLISH IT. BUT CLEARLY, THIS IS A TOUGH PROBLEM. IF IT WAS EASY, WE WOULD HAVE INVOLVED -- SOLVED IT BY NOW AND WE ALSO HAVE ONE VERY IMPORTANT LABORATORY TO TEST OUT APPROACHES AND THAT'S OUR IN/TRA INTRAMURAL PROGRAM, WHICH IS I'M SORRY TO SAY ALSO WOEFULLY LACK LACKING IN DIVERSITY. AND ANYTHING THAT WE ARE THINKING ABOUT TRYING IN TERMS OF REACHING OUT AND MAKING SUCH PATHWAYS MORE ATTRACTIVE AND FIGURING OUT HOW /TTO RETAIN PEOPLE WHO DEVELOP THAT INTEREST -- WE OUGHT TO BE ABLE HERE BECAUSE WE HAVE MUCH MORE CONTROL OVER WHAT'S GOING ON TO MODEL THAT AND THAT'S GOING TO BE ANOTHER BIG PART OF DR. VALEN VALENTINE'S EARLY CONTRIBUTIONS. IN FACT, I'M MEETING WITH HER THIS AFTERNOON TO TALK ABOUT HOW EXACTLY WE MIGHT GET THIS UNDER WAY. SHE'S BEEN HERE ONLY A FEW MONTHS PLANNING A LOT ABOUT REACHES TO UNIVERSITIES SO YOU WILL PROBABLY BE HEARING FROM HER ABOUT THAT BECAUSE WE AT NIH CAN DO /STKWRUFPLT BUT UNLESS WE HAVE THE FULL SUPPORT OF OUR MAJOR GRANTEE INSTITUTION, IT'S ONLY GOOD AS TO GO MARSHAL -- PARTIALLY SUCCESSFUL. >> THANK YOU. ALREADY ANY LAST QUESTIONS OR COMMENTS FOR DR. COLLINS? DR. NELSON? >> HI. I'M HIEIDI NELSON. I HAVE A POPULATION VIEW OF THE WORLD AND MOSTLY ON THE CLINICAL SIDE AND SO THE VERY NICE PIECE -- INAUDIB[INAUDIBLE] WAS WELL-RECEIVED ACROSS THAT GROUP, OF COURSE. BUT AS /I WALK ACROSS THE CAMPUS -- >> YEAH. RI >> I JUST HAPPEN TO THINK IT'S A CULTURE GAP BETWEEN PERCENT PERCENTOFFS AND I WONDER IF YOU HAVE ADVICE ABOUT HOW -- GETTING A LITTLE CRAZY ABOUT THE. DO YOU HAVE ADVICE ABOUT GETTING THE TROOPS IN LINE TO EMBRACE THIS? >> YEAH. I THINK THAT MOST EFFECTIVE STRATEGY IS TO APPEAL TO OUR COMMUNITY'S DESIRE TO ACTUALLY DISCOVER SCIENTIFIC TRUTHS. AND THE WAYS IN WHICH THAT CAN BE APPLIED TO HUMAN HEALTH, TO HELP SAVE LIVES AND PREVENT DISABILITY. SO IF YOU HAVE GOOD EXAMPLES TO OFFER UP /SAND WE'VE PUT QUITE A FEW OF THOSE IN THAT COMMENTARY, I'M SURE THERE ARE OTHERS AS WELL -- TO PUT IN FRONT OF THE BASIC SCIENCE COLLEAGUES WITH REALLY INTERESTING FINDING AND BY DOING A CAREFUL COMPARISON OF MALES AND FEMALES AND THEY, AS SCIENTISTS, /WHAOPBT WANT,000 OF MIFFED THAT. THAT PROBABLY IS MORE COMPELLING THAN SAYING WELL, YOU SHOULD DO THIS BECAUSE IT'S THE RIGHT THING TO DO. THEY'RE PROBABLY NOT GOING TO BE HAPPY WITH HAVING FINGERS POINTING AT THEM. BUT SCIENTISTS WANT TO DO SCIENCE THAT'S GOOD AND PROVIDES THE MAXIMUM KNOWLEDGE THAT'S GOING TO BENEFIT HUMANITY. SO A PRETTY DARN -- GOOD CASE TO MAKE THERE AND ONCE PEOPLE STOP /TKPWROUFPG, THAT SOMETIMES IS GOOD THERAPY AS WELL. LISTEN TO /TTHAT A LITTLE BIT AND SAY BUT LOOK WHAT THIS COULD LEAD TO IT AS FAR AS ADVANCE S IN YOUR OWN RESEARCH AND PEOPLE HAVE DONE THIS IN OTHER FIELD AND IT HASN'T TURNED OUT TO BE THE END /-OF THE WORLD. IN FACT, IT WAS BENEFICIAL SO YEAH, GET THEM TO SORT OF MAKE THAT TRANSITION. MENTAL. I THINK IT CAN HAPPEN. >> SHORT QUESTION FOR DR. COL COLLINS. >> THANK YOU VERY MUCH. WE ARE VERY EXCITED ABOUT THIS INITIATIAT THE UNIVERSITY, I COME FROM THE WORLD OF SOBCIO CULTURAL BEHAVIORAL WORLD AND THERE IS A REPRESEUTATION THAT IT IS VERY DIFFICULT NOW TO REALLY INCLUDE THE SOCIAL CULTURAL BEHAVIORAL WORLD WITH BIOLOGICAL SCIENCE AND THEN WE KNOW THE DETERMINE DETERMINANTS OF HEALTH ARE REALLY COMING A LOT MORE FROM THAT SOCIAL STRUCTURE SO I'D LIKE TO JUST HEAR YOUR VIEWS ABOUT THAT WORLD AND HOW MUCH SUPPORT NIH WOULD BE GUSTING THOSE SCIENTISTS WHO TEND TO BE MORE THAN -- IN THE SCIENCE THAN THE CULTURAL AND ETHNIC ISSUES, WHICH DEFINITELY AFFECT EVERYTHING, INCLUDING THE GENES, TOO. >> I AGREE WITH YOU. THOSE ARE FUNDAMENTAL LY IMPORTANT ISSUES THAT ARE GOING TO HAVE MAJOR EFFECT ON HEALTH OF INDIVIDUALS AND OF GROUPS. CERTAINLY SOCIAL DETERMINANTS OF HEALTH. I THINK MANY OF US WOULD CONSIDER AS ONE OF THE AREAS OF MOST PROMISE RIGHT NOW IN TERMS OF CHRONIC DISEASE WHAT TO DO TO TRY TO ACHIEVE BETTER EFFECT IN TERMS OF PREVENTION AND TREATMENT. OBVIOUSLY, PEOPLE WORKING IN THAT FIELD SHOULD BE COMING TO US WITH THEIR BEST AND BRIGHT EST IDEAS. THEY MAY FEEL LIKE THEY'RE NOT GETTING A WARM RECEPTION BECAUSE NOBODY'S GETTING AS WARMER RE RECEPTION RIGHT NOW AS THEY WOULD LIKE SO IF YOU'RE IN THAT AREA OF SOCIAL DETERMINE /STKPHAPBTS YOUR GRANT GETS RE/SKWR-BGTED, I DON'T HOPE THAT -- YOU ASSUME THAT NIH IS BIASED AGAINST YOU. I WOULD ASSERT THAT THE AREA OF SOCIAL DETERMINANTS CERTAINLY IS NOT -- IF ANYTHING, I THINK THERE IS SORT OF A GROUND SWELL OF ENTHUSIASM THAT THERE ARE OPPORTUNITIES HERE THAT NEED TO BE CAPITALIZED ON AND MAYBE HAVEN'T BEEN PURSUED AS VIGOROUS VIGOROUSLY AS SOME OF THE BIOLOGICAL ISSUES. NOT TO SAY THAT SOCIAL DETERMINE DETERMINANTS AREN'T BIOLOGICAL AS WELL BUT I HOPE YOU KNOW WHAT I MEAN. I WOULD BE ENCOURAGING THE COMMUNITY, "HEY, BRING YOUR BEST IDEAS." WE'RE GOING TO SURE SUPPORT WHAT WE CAN WITH THE RESOURCES WE'VE GOT. ALL RIGHT. >> THANK YOU, DR. COLLINS. WE REALLY APPRECIATE YOUR JOINING US FOR THIS. >> THANK YOU. /PHRA [APPLAUSE] >> SO WOULD TRANSITION HERE /TO MY DIRECTOR'S REPORT, DR. MYERS MYERSERS -- IN ONE SECOND. I HOPE YOU ENJOYED DR. ^COLLINS' REMARKS AND THE OPPORTUNITY TO ASK HIM QUESTIONS. I ALSO WANT /TO MAKE /SHAOUSURE. I DON'T KNOW THAT THEY HAVE THIS THIS. OKAY. WE'LL PASS THAT ALONG. THIS IS ONE OF THE THINGS THAT I WANT ED TO DRAW TO YOUR ATTENTION OUR NEWEST PORTABLE ITEM. YOU CAN TAKE THIS WITH YOU. YOU CAN HAVE IT WITH YOU AT ALL TIMES. ALL RIGHTY. I AM GOING TO SHARE WITH YOU -- CAN YOU ALL HEAR ME? IS IT SOUNDS I-- A LITTLE LOW. CAN YOU HEAR ME? OKAY, HOW ABUT THIS? IS THIS A LITTLE BETTER? OKAY. I THINK THAT'S A LITTLE BETTER. I WANT TO SHARE WITH YOU WHERE WE ARE TODAY IN OR /W-FPWH RESEARCH AT WOMEN'S RESEARCH AT NIH AND I LOOK FORWARD TO HEARING YOUR THOUGHTS ABOUT THE PATH FORWARD. I'D LIKE TO THINK OF EVERYTHING AS /AA NEW DAY. SOMEBODY SAID THAT TO ME TOMORROW -- THIS MORNING AND SOMEBODY ASKED ME HOW I'M DOING, I TRY TO SAY -- I TRY TO THINK ABOUT IT MOVING FORWARD BECAUSE THAT'S WHERE WE'RE GOING SO WE WANT /TO WELCOME EVERYONE HERE TODAY, AS DID I EARLIER, BUT THOTELL YOU I THINK OF EVERY SINGLE QUESTION HERE AS -- PERSON HERE AS /AA PARTNER. DR. COLLINS USED THE TERM AS PART OF OUR NEW ARMY. IN /THIS ISSUE, IN MOVING IDEAS AND CONCEPTS FORWARD ABOUT CONSIDERING /SAEBGS A BIOLOGICAL VARIABLE. SO AS YOU LEAVE TODAY, YOU ARE NEW PARTNERS WITH US. WE DO HAVE SOME NEW STAFF I WANT TO INTRODUCE YOU TO. YOU HAVE MET SEVERAL AT THE MEETING BUT I WANT TO INTRODUCE YOU TO A COUPLE /OF STAFF MEMBERS COMMUNICATION -- SHE SPENT TIME IN THE OFFICE OF COMMUNICATION -- I DON'T THINK BONNIE'S HERE. SHE'S AT ANOTHER MEETING. AND JEFF IS OUR NEWEST -- NEWEST ADMINISTRATIVE OFFICE TAKING CARE OF THINGS THAT ARE SORT OF -- AND I ALSO WANT /TO WELCOME DR. SULLIVAN, WHO IS HERE. SHE'S A PRESIDENTIAL MANAGEMENT FELLOW AND JOINED US VERY RECENTLY AND DR. WE HDDINGTON, WHO IS HERE AS WELL, AN ASSOCIATE PROFESSOR IN PORTLAND, ORGANIEGON. SO THOSE ARE STAFF MEMBERS AND ON THE OR /W-FPWH WEBSITE WE DO HAVE BIOS, SO YOU CAN TAKE A LOOK THERE SO YOU CAN HEAR ABOUT ALL THE EXCITING THINGS THAT THEY'VE DONE BEFORE THEY CAME HERE AND WE'RE REALLY LOOKING FORWARD TO WORKING WITH ALL OF THEM. A SNAP SHOT OF OUR EXPERIENCE THIS /KWRAYEAR. AS OF SEPTEMBER 17TH IN TERMS OF HOW WE HAVE INVESTED OUR RESEARCH FUNDS. SO I WANT TO SHARE WITH YOU THAT THE VAST MAJORITY OF FUNDS HAVE GONE TO OUR RESEARCH. /3W 1%. OUR PROGRAM, WHICH IS ABOUT TWO YEARS OLD, -- INAUDIBL[INAUDIBLE] THIS OTHER CATEGORY REPRESENTS A VARIETY OF ACTIVITY THAT WE HAVE OR INSTITUTE AND CENTER ON WITH COLLEAGUES -- COLLEAGUES. WE INSTITUTED A NEW PROCESS FOR REVIEW OF THOSE REQUESTS BASED ON WHETHER THE REQUESTS MEET GOALS AND OBJECTIVES. AND SO WE HAVE A NEW PROCESS THAT -- FOR THAT AND ABOUT 11% OF OUR RESEARCH FUNDS WERE SPENT IN THAT WE ATHIS YEARY AND /AA PROGRAM WHICH IS A BRIDGE PROGRAM AND WE WERE ABLE TO SUPPORT A VARIETY OF AREAS THERE AS WELL. SO WE'LL GO RIGHT INTO THAT AND WE'RE LOOKING FORWARD TO NEW AP APPLICATIONS THAT ARE COMING IN FROM THOSE PIS BASED ON THEIR ABILITY TO CONTINUE THE WORK AND DO CRITICAL WORK THAT NEEDED TO BE DONE TO COME BACK IN FOR ANOTHER APPLICATION. ON THE BOTTOM LEFT YOU CAN SEE THE ORIGINAL OR /W-FPLWH FUNDING. CLEARLY IT'S AN EXTREMELY CHALLENGING FISCAL ENVIRONMENT, WHICH WE HAVE INTERPRETED AS IMPETUS FOR US TO REALLY BE CAREFUL ABOUT WHAT WE CHOOSE TO AND TO ASSESS AND EVALUATE WHAT WE'RE DOING AND WHY WE'RE DOING IT AND DETERMINE WHETHER DOING SOMETHING FIRE LONG /PEPERIOD OF TIME HAVING ACHIEVED THE OBJECTIVE. IS IT FIREARM HANDOFF? OR WE NEED TO TWEAK OR ADJUST IT IT? WE NEED TO CLEARLY SAY TO OUR COLLEAGUES THIS IS WHAT WE'RE GOING IN 2015 FORWARD. WE WILL /BE VERY INTERESTED IN UNDERSTANDING HOW WELL WE'VE R INSTITUTES, CENTERS AND DONE THERE, IN PARTNERSHIP WITH COLLEAGUES. THIS SHOWS THE THREE MAIN ITEMS THAT ARE IN OUR MISSION AND /TEURPZ THAT WE'RE USING TODAY. WE ARE ABOUT IMPROVING THE HEALTH OF WOMEN. THAT'S THE /PWOPBOTTOM LINE. WE DO THAT TODAY BY EXAMINING SEX AND GENDER INFLUENCES AND -- IN WOMEN'S HEALTH AND WE DO THAT BECAUSE WE WANT /TO IN/TPORPFORM AND IM IMPROVE WOMEN'S HEALTH AND WOMEN WOMEN'S HEALTH RESEARCH. THAT'S THE APPROACH AND THE PERCESPECTIVE AT WHICH WE'RE COMING TO /TTHAT SEX AND GENDER INFLUENCES CONVERSATION. WE CANNOT -- CONTINUE TO BE DED DEDICATED TO ENSURING THAT WOMEN AND DIVERSE POPULATIONS ARE INCLUDED IN NIH-FUNDED CLINICAL RESEARCH THIS CONTINUES TO BE AN ISSUE OF IMPORTANCE, AND WE ARE SUPPORTING THE PROMOTION OF WOMEN IN SCIENCE CAREERS, BOTH AT THE RECRUITMENT, RETENTION AND ENTRY LEVEL AND SUSTAINED ADVANCEMENT OF WOMEN IN BIO BIOMEDICAL CAREERS AND MANY SECTOR WE SEE THAT WOMEN ARE 15% OF MEDICAL STUDENTS, OF EARLY FA FACULTY AND THEY ARE NOT PROGRESS TO THE TOP LEADERSHIP POSITIONS AT A RATE COMPARABLE TO THEIR COLLEAGUES. I'LL TALK ABOUT THE FIRST TWO ITEMS I MENTIONED. INCLUSION IS A WORD THAT IS REALLY ASSOCIATED WITH THE OFFICE OF RESEARCH ON WOMEN'S HEALTH AND INDEED THE OFFICE WAS FORMED OUT /OF ENERGY THAT CAME OUT /OF AFFIDAVIT /KADVOCACY FROM THE WOME N'S CAUCUS IN CONGRESS, FROM SCIENTISTS AND OTHERS, WHO RECOGNIZED THAT WOMEN WERE NOT BEING INCLUDED ROUTINELY IN CLINICAL RESEARCH AND THAT FINDINGS FOR MEN WERE BEING /PHRAOEUD TO WOMEN. THE WAY WE THINK ABOUT INCLUSION NOW IS BEYOND INCLUSION. TWO OF THE CONSIDERATIONS OF SEX AND GENDER INFLUENCES ON HEALTH AND DISEASE THROUGHOUT THE RESEARCH CONTINUUM. FROM THE VERY BEGINNING BASICALLY SCIENC RESEARCH PRE PRECLINICAL RESEARCH OF SEX AND GENDER PERCENTIVE /SKH-GING TO CONSIDER WHAT INFLUENCE DOES THE VARIABLE OF SEX HAVE ON YOUR /STPHERPBLGTS HAVE YOU CONSIDERED THAT? IT NEED TO BE CONSIDERED FROM THE VERY BEGINNING AND SO WE'RE ASKING SCIENTISTS TO DO THAT. IT'S DONE QUITE UNITE UP THE -- ROUTINELY NOW BUT NOT EVERYWHERE EVERYWHERE. AND OF COURSE, AS WE TRANSLATE INTO CRITIC -- CLINICAL PRACTICE THE EARLY PHASE AND PHASE TWO AND THREE CLINICAL /TRAOEUTRIALS AS WELL, IMPORTANT TO GET THAT PERCESPECTIVE THROUGHOUT. ONCE THOSE STUDIES ARE PERFORMED THAT DATA NEED TO BE REPORTED IN A /SHEPBGS SPECIFIC WAY. SEX-SPECIFIC DATA ANALYSIES NEED TO BE PERFORMED, AS APPROPRIATE. NOT ANALYSES THAT ARE UNDER -- BUT AS APPROPRIATE AT A MILAN MUM THE DATA NEED TO BE RTED IN /AA WAY SO WE CAN LEARN FROM EVERY SINGLE EXPERIMENT WE'RE DOING. ONE OF THE WAYS I THINK ABOUT THIS PARTICULARLY CONSTRAINED ENVIRONMENT IS THAT WE ABSOLUTELY HAVE TO LEARN AS MUCH AS WE POSSIBLY CAN FROM EVERY SINGLE RESEARCH DOLLAR WE HAVE TO MAXIMIZE OUR RETURN ON INVESTMENT. IT'S SO IMPORTANT. AND OF COURSE, AS WE LEARN THE THINGS WE NEED TO SHARE THOSE /TWHEUPBGZ OUR COLLEAGUES AND WITH THE PUBLIC AND THAT NEEDS TO BE TRANSLATED INTO HEALTH POLICY, SCIENCE POLICY, THAN A FORMS BIOSCIENCE AND ULTIMATE LY HEALTHCARE. BUT GENDER-APPROPRIATE SO THAT EACH OF US GETS THE INDIVIDUAL INDIVIDUALIZED PATIENT-CENTERED CARE THAT WE ALL NEED AND DESERVE DR. COLLINS MENTIONED NIH EFFORTS AROUND ENHANCING RE RE/PRAOPRODUCIBILITY, AND THAT REALLY THE ISSUE THAT HIGHLIGHTED THERE IS ATTENTION TO EXPERIMENTAL DESIGN AND IN PRECLINICAL RESEARCH. AND THAT THERE IS SOME IM IMPROVEMENT IN TRAINING OF RESEARCHERS. THE DESIGN THAT'S NEED AND HERE PAY ATTENTION TO THE MIDDLE OF THE PARAGRAPH WHERE SHE MENTION MENTIONED "CRUCIAL EXPERIMENTAL DESIGN ELEMENT THAT ARE ALL /TTOO FREQUENTLY IGNORED. WE'RE TALKING IN THE PRECLINICAL STAGE, INCLUDING MASKING, RANDOM IZATION, REPRESELICATION, SAMPLE SIZE CALCULATIONS, AND THE EFFECT OF SEX DIFFERENCES." SO WE'RE PARTICULARLY ATTENDING TO THAT AS PART OF OUR ES TO IMPROVE RE/PRAOUS PRODUCIBILITY AS YOU KNOW IN MAY WE WERE FORTUNATE TO RELEASE THIS COMMENTARY, WHERE WE TALKED ABOUT OUR EFFORTS TO BALANCE SEX IN ANIMAL STUDIES. AND AS /AA FOLLOWUP, DR. COLLINS POINTED OUT THAT OVER /THE PAST TWO DAYS WE LEARNED A GREAT DEAL ABOUT HOW MEN AND WOMEN RESPOND RESPONDED TO DIFFERENT MEDICATIONS. THAT INFORMATION CAME AFTER A CONSERVATIVE EFFORT IN THE EARLY 1990'S TO INCREASE THE NUMBER OF WOMEN IN NIH-FUNDED CLINICAL PRETTY MUCH -- RESEARCH AND I POINT THAT OUT BECAUSE IT REQUIRED A CONCERTED EFFORT AND THAT WAS LEGISLATION SO WE KNOW THAT WE WILL NEED TO APPLY A CONCERTED STRATEGICING AND /KHRUBGTIVE EFFORT TO IN INCREASE THE CONSIDERATION OF STUDYING BOTH FEMALES AND MALES TO INCREASE CLINICAL RESEARCH AND ARE ENCOURAGING THAT APPROACH. SO >> -- WHERE ARE WHEN HE NOW? TO UPDATE YOU OF THE LANDSCAPE OF THE KINDS /OF FACTORS THAT ARE AFFECTING THE OFFICE. I WILL SHARE WITH YOU THERE, AS DR. COLLINS ALLUDED TO, CREDIBLE INTERESTS FROM A VARIETY OF MEMBERS. JUST TO HIGHLIGHT A FEW THINGS. A BILL THAT WAS INTRODUCED. SOME VERY SPECIFIC AND QUITE PRESS /SKREUCRIPTIVE LANGUAGE IN IT REPRESENTING MORE THAN THE -- CENTERED AROUND PRECLINICAL RESEARCH AND YOU WILL HEAR LATER FROM LAN LANA ABOUT UPDATE ABOUT THOSE ISSUES. AND THE DEPUTY DIRECTOR OF EXTRA EXTRAMURAL RESEARCH AND I WENT DOWN TO THE HILL AND HELD A BRIEFING ON INCLUSION AND PRE PRECLINICAL RESEARCH AND INFORMATION ABOUT WHAT THE DIFFERENCES ARE FROM THE PRE PRECLINICAL PHASE TO THE CLINICAL STAGE TO HELP OUR COLLEAGUES UNDERSTAND THERE ARE BUT YOU THAT IS MORE A NUMBERS GAME. THIS IS ABOUT COUNTING ANIMALS. THIS IS A PERCESPECTIVE TO -- THAT APPLIES TO PRECLINICAL RESEARCH, WHERE THE -- WE ARE STUDYING BOTH SEXS AND LOOKING AT THE DATA /SPWRAT LLY. IN OUR EFFORT TO INFORM THE DEVELOPMENT OF NEW POLICY THAT WILL BE COMING OUT, WE'RE GOING TO -- WORKING GROUPS WITH MEMBERS FROM MOST OF THE STUDENT THAT DR. ROCKY AND I WILL CO- CO-SHARING AND THE INFORMATION WAS RECENTLY RELEASED ON SEPTEMBER 11. AND I WOULD ENCOURAGE TO YOU HELP US GET THE WORD OUT AS BROADLY AS POSSIBLE ABOUT THE RF RFI. WE WANT /TO HEAR FROM YOU. THIS IS A CONVERSATION THAT WE WELCOME. IT'S AN IMPORTANT CONVERSATION. WE ARE TRYING TO IMPLEMENT A MEANINGFUL CHANGE IN THE THOUGHTFUL AND /THREUBT WAY AND WE VALUE YOUR IN/PPUT. WE NEED YOUR IN/PPUT AND PLEASE HELP US TO GET THE WORD OUT BROADLY ABOUT THAT. ANOTHER ISSUE I WANT TO LAY ON THE TABLE IS SOMETHING THAT'S IN THE WORKS IS /THE ISSUE OF THE REQUIREMENTS OF PUBLISHERS AROUND REQUIRING AUTHORS TO PDE INFORMATION ABOUT THE SEX OF THE ANIMALS OR THE SEX IN THEMSELVES. OR WE'VE SEEN CHANGES THERE. I HAVE TO SAY THAT DESPITE THE FACT THAT WE'RE SEEING SOME CHANGES, I HAVEN'T SEEN THAT THAT HAS TRICKLED INTO THE ACTUAL PUBLICATIONS. IT'S VERY CONCERNING TO ME THAT -- THAT ARE REQUIRING THIS, I AM NOT SEEING THAT HAPPEN IN THE ACTUAL PAPERS SO I DON'T KNOW IF THERE IS AN ISSUE THERE IN TERMS OF REVIEW AND HOW WE'RE IMPLEMENTING. SO THAT JUST POINTS OUT TO ME WHEN YOU DEVELOP A POLICY, THERE IS A REASON TO DO THIS BECAUSE WE KNOW SEX MATTERS T CAN MATTER IN DIFFERENT CIRCUMSTANCES. YOU REALLY HAVE TO DO THE FOLLOW FOLLOWUP AND SEE WHAT HAPPENS. AS DR. COLLINS MENTIONED, WE'RE JUST AT THE BEGINNING OF THAT DISCUSSION. I DO WANT /TO POINT OUT A COMMENT FROM THE PROGRAM AND COMMON FUND LED BY DR. ANDERSON JUST ANOTHER EXAMPLE FROM NOW -- HOW ONE PROJECT HAS ACCOUNT /ED FOR SEX. AND THIS IS THE KNOCKOUT MOUSE PROJECT, ALSO KNOWN AS COMP, AND I'M STARTING HERE ONE OF THE PUBLICATIONS THAT LOOKS TO CHARACTERIZE A FEPHENOTYPE OF 472 KNOCKOUT MIKES -- MICE. WHAT I'M HIGHLIGHTING HERE IS IN THEIR SECTION ON RIGOR UTILITY, THEIR WORDS, THEY TALK ABOUT HOW THEY HAVE A STANDARD /AOEUIZED A APPROACH TO THE FENE TYPING PROCESS VALID /A*ATED AS THEY PERFORMED WITH AN /PHAFLDZ BOTH SEXES AT THE SAME AGE IN THE SAME ORDER AND VERY CAREFULLY THOUGHT ABOUT THIS FROM THE VERY BEGINNING AND THEY REPORT THE DATA ALSO FOR FEMALES AND FOR MALES AND THAT DATA IS AVAILABLE PUBLICLY. THIS IS ONE /OF MANY APPROACHES TO ACCOUNT FOR SEX AS /AA BIOLOGICAL VARIABLE AND I CAN SHARE WITH YOU THAT ALREADY BY LOOKING AT THE DATA THIS WAY NEW THINGS HAVE BEEN FOUND. AND SO THAT'S REALLY EXCITING AND JUST ONE EXAMPLE OF /AA PROGRAM THAT NIH /SKPHRUD HOW WE ARE TAKING -- HOW THEY ARE GOING ABOUT THIS, EXCUSE ME. WHAT ABOUT THE ISSUE OF USING CELLS?{}A LITTLE BIT MORE COMPLICATED, YES. THE SEX AND ORIGIN OF PRIMARY CELLS, /TKPR*ELZ TISSUE, CULTURES IS EASY TO RECORD. IT DOESN'T GET DONE ALL THE TIME, HOWEVER. BUT IT IS AT LEAST NOBLE. BUT THERE ARE SITUATIONS WHERE IT'S NOT SO STRAIGHTFORWARD TO IDENTIFY THE SEX THEMSELVES. AND THEN ADDITIONAL CONSIDERATIONS IN CELL LINES THE GENOMIC INSTABILITY AND THE FACT THAT SOME OF THESE CELL LINES DON'T HAVE THEIR SEX CHROMOSOMES ANYMORE. THEY HAVE CHANGES THAT HAVE OWE OCCURRED IN THEIR CELLS. ALL OF THOSE ARE IMPORTANT. AND SO THAT'S AN AREA THAT HAS INCREASED ATTENTION TO SOMETHING THAT WE CAN UNDERSTAND THE WHOLE ISSUE OF AUTHENTICATION OF CELL LINES. WHAT ARE YOU SAYING? DO YOU KNOW? HOW DO YOU CHECK THAT? SO THERE ARE BROADER ISSUES BEYOND JUST UNDERSTANDING THE /SAEBGS AS A CELL LINE THAT ARE IMPORTANT AND SO SEX IS PART OF THAT DISCUSSION, BUT IT IS A BROADER SEX -- DISCUSSION. IT IS IMPORTANT TO KNOW HE WHEN YOU LOOK AT /THIS CELL, WHETHER THEY ARE FEMALE OR MALE BECAUSE THAT MAY HELP US TO DISCOVER SOMETHING NEW. THAT MAY HELP US TO CHARACTERIZE A PATHWAY THAT'S DIFFERENT IN MALES AND FEMALES. A CELL DEATH PATH WWAY THAT'S DIFFERENT IN MALES AND FEMALES AND THAT COULD BE CLINICAL LY RELEVANT AND IMPORTANT FOR IDENTIFYING THERAPEUTICS. YOU MAY WASTE TIME AND MISS OPPORTUNITIES IF YOU DON'T THINK ABOUT THIS. SO WHERE YOU THINK ABOUT IT, HOW YOU LOOK AT YOUR DATA ARE SOME OF THE S WE THAT WE HAVE FOR INVESTIGATORS WHO USE CELLS IN THEIR EXPERIMENT. SO SHIFTING GEARS HERE. JUST TO TELL YOU ABOUT WHAT WE'VE BEEN DOING IN /THIS AREA FOR SOME TIME. AS YOU KNOW, OUR SPECIALIZED CENTERS ON SEX DIFFERENCESS HAVE BEEN FUNDED SINCE 2002 AND PRESENT HAVE 11 CENTER AND AN OFFICE WHICH REPRESENTS 4 OF 12 IT 3 MILLION HAVE GONE TO SPECIALIZED CENTERS IN SEX DIFFERENCES AND I'LL TALK ABOUT THEM GOING FORWARD. THE ADMINISTRATIVE SUPPLEMENT PROGRAM. WE INTRODUCED FOR THE FIRST TIME LAST YEAR. AND AGAIN THIS /KWRAYEAR AND ANNOUNCE ANNOUNCED THOSE 82 AWARDS. WE FOCUSED -- REEMPHASIZED THE PRECLINICAL RESEARCH PHASE IN THIS YEAR'S /STKPHOUPLT WE'RE UP TO 10.8 MILLION AND 1100 FUNDED PROGRAM WITH ALL THE CENTERS THAT HAVE ACTIVITY CODE THAT WERE ABLE TO BE SUPPLEMENTED. SO WE'RE SO EXCITED ABOUT THAT. WELCOME, DOCTOR. WHAT I WANTED TO SHOW YOU HERE. THE CIRCLE ARE THE SCORES. SO YOU CAN SEE SCORES ARE SCATTERED ABOUT AND THEN THE CIRCLED ARE SUPPLEMENTS FROM FISCAL YEAR 13 AND 14 AND SO -- THANK YOU, DR. MYERS. SO YOU CAN SEE THEY ARE SCATTER SCATTERED ABOUT THE COUNTRY AND WE'RE EXCITED THAT THAT MEANS THAT IN ALL OF THOSE /PHRAUSS, AT LEAST THOSE INDIVIDUALS ARE ASKING THEMSELVES A QUESTION " "HOW'D THIS INFLUENCE MY RESEARCH QUESTION? WHAT INFLUENCE DOES HAVE -- THAT HAVE IN THE CHON TEXT OF MY HYPOTHESIS? AND WE'RE HOPING, OF COURSE, THAT THAT WOULD SPREAD AND THEY WOULD SHARE THAT INFORMATION, THAT PERCESPECTIVE AND THAT DISCUSSION WITH THEIR COLLEAGUES NATIONWIDE. HERE ARE SOME OF THE TOPICS THAT ARE ADDRESSED IN OUR SPECIALIZED CENTERS OF RESEARCH ON SEX DIFFERENCES. IT'S MY PLEASURE TO SHARE WITH YOU ALL THE INSTITUTES THAT ARE COLLABORATING WITH US, AS WELL AS THE FDA'S OFFICE OF WOMEN'S HEALTH WHO HAS BEEN WITH US AT THE BEGINNING. WE'RE ADDRESSING ISSUES AS DIS DISPARATE AS DISASTER AND FUNCTION AND COG /TPHENITIVE DECLINE WITH AGING INSTITUTE TO SEX DIFFERENCES AND LOOKING -- SMOKING AND COCAINE WITH THE NATIONAL /EUINSTITUTE ON DRUG ABUSE ABUSE, TREATMENT FOR TOBACCO DEPENDENTS, -- DEPENDS -- DEPEND ENCE, AND ANOTHER EXAMPLE. SO WE'RE ADDRESSING A WIDE VARIETY OF ISSUES THAT ARE OF CLINICAL IMPORTANCE. THESE ALL HAVE PRIORITIES TO WOMEN'S HEALTH ISSUES, EVEN THOUGH THEY ARE APPROACHING IT FROM A SEX DIFFERENCES PERCENT PERSPECTIVE. HERE ARE SOME OF THE TOPICS THAT HAVE -- THAT ARE ADDRESSED AND USED IN THE SUPPLEMENTS PROGRAM. THESE AWARDS RANGE FROM STUDIES THAT ARE HOPING TO CHARACTERIZE THE MOLECULAR AND FUNCTIONAL MECHANISM WITH HEART FAILURE AND CHILDREN WITH HEART FAILURE TRANSLATING MOLECULAR SIGNAL PATHWAYS TO ORTHO/PAOPEDIC TRAUMA CARE AND STROKE AND ONE /OF MY PARTICULAR INTEREST, PLASTIC WRIT IN MI MIGRAINES. VERY INTERESTING FINDING THERE. WE KNOW MIGRAINES IS MUCH MORE COMMON NOT AND FEMALES ARE BEING ADDED TO THIS. ANOTHER FASCINATING AREA. THERE IS A SUGGESTION THAT RENAL CELLS DO DIE IN /AA DIFFERENT WAY IN MALES AND FEMALES AND WE KNOW OF THE MEN, MUCH MORE /TKPH-PB WOMEN THAN IN WOMEN AS ARE MOST AUTOIMMUNE DISEASE. HOWEVER, ALL THE MEN ARE THAN WOMEN. SOME OF THE APPROACHES THAT HAVE BEEN USED. SOME INVESTIGATORS HAVE ADDED A SECOND SEX OF ANIMALS HELLO OF THE OPPOSITE SEX IN BOTH CASES BUT NOT ALL, IT WAS ADDING FEMALES. THESE APPROACHES LEVERAGE EXIST EXISTING SAMPLES IN TECHNOLOGY. AND IN SOME CASES THEY ARE FLOORING DIFFERENCES IN EP EP/SKWREPIGENETIC MARKS. THEY ARE LOOKING AT DIFFERENCES IN DISEASE OUTCOMES AND COM /PU COMPUTATIONAL MODELS. SO A WIDE VARIETY OF APPROACHES ARE BEING USED IN THESE ADMINISTRATIVE SUPPLEMENTS. THIS SLIDE SHOWS HAD YOU THE HEALTH TOPICS THAT ARE BEING ADDRESSED IN THE ADMINISTRATIVE SUPPLEMENTS. CLASSIFICATION, WHICH IS THE CURRENT CLASSIFICATION ON WHICH WOMEN'S HEALTH DATA IS REPORTED IS /THE /KRAURD AND PULMON ARARY CATEGORY. THAT'S ONE OF THE REASONS. AGAIN, THESE ADMINISTRATIVE SUPPLEMENT WERE BASED ON THE TOP TOPIC OF THE PARENT GRANT. THEY COULD NOT GO BEYOND THE SCOPE OF THE PARENT GRANT. THOUGH THEY ARE RELATED TO WHAT WAS ALREADY BEING FUNDED. WE WANT TO SHARE WITH YOU WHICH INVESTIGATORS AND WHAT BACKGROUND THEY WERE COMING FROM FROM. SMALL CONTRIBUTION FROM CANCER THERE. THE SCIENTIFIC APPROACH USED BY THESE ADMINISTRATIVE SUPPLEMENTS SUPPLEMENTS. ON THE LEFT THERE YOU CAN SEE THE SCIENTIFIC APPROACH. SO THE /SHRAFT MAJORITY THEY WERE ANALYZING EXISTING DATASETS AND ADDING NEW SEX TO SINGLE-SEX RESEARCH AND ADDING SUBJECT TO INCREASE HE. WAS ANOTHER APPROACH. REMEMBER THIS IS /SKPHREUPBL PRE PRECLINICAL RESEARCH SO ALL- ALTOGETHER THAT'S WHERE WE ARE NOW IN TERMS OF TAKING /AA LOOK AT THESE APPROACHES.pTHESE INVESTIGATORS HAVE CHOSEN TO TAKE. PRECLINICAL AND CLINICAL RESEARCH. WE'RE TRYING TO GET PRECLINICAL RESEARCH IN THERE. DRAWING /KWRYOUR ATTENTION TO OUR MOST RECENTLY RELEASED MODULE OF THE SEX AND GENDER COURSE, WHICH IS ALSO A COLLABTION WITH THE FDA'S OFFICE OF WOMEN'S HEALTH AND THE SEX AND GENDER DISEASE EXPRESSION AND TREATMENT AND IT COVERS AREAS THAT HAVE BEEN PARTICULARLY CHALLENGING. FOR EXAMPLE, CARD /KWRO /SRAFIOVASCULAR DISEASE OF WOMEN IN HEART OF HEART FAILURE, WHICH HAPPENS TO BE AN AREA THAT'S CHALLENGING IN TERMS OF WOMEN IN CLINICAL STUDIESIF FOR A WATER -- VARIETY OF REASONS. THE /TPHARNATIONAL HEART PLUNGE AND BLOOD INSTITUTE VERY INTERESTED IN THAT AREA AND IS TAKING ON A SPECIFIC ACTIVITY. I WAS JUST AS -- AT A WORKSHOP LOOKING AT SEX, BIAS AND CARDIO VASCULAR TRIAL. SEX DIFFERENCE S S IN PAIN IS CLEARLY AN ISSUE. SEX DIFFERENCES IN SUBSTANCE ABUSE AND TREATMENT. THESE ARE ALL VERY TUM LY. WE HAVE INCREDIBLE ISSUE IN /THIS COUNTRY. ALL VERY TIMELY TOPICS OF PULMON ARY HEALTH THAT PROBABLY DOESN'T GET AS MUCH ATTENTION IN TERMS OF SOME VERY, VERY HORRIFIC DISEASES THAT PULMON ARARY DISEASE THAT'S AFFECT WOMEN THAT REALLY ARE A DEATH SENTENCE FOR WHICH WE HAVE VERY LIMITED TREATMENT. PULMON ARARY FIGROSS -- FI/PWROEBROSIS IS WHAT I AM TALKING ABOUT. I WANT TO TALK ABOUT OUR WEBSITE WEBSITE. HERE WE'RE TRYING TO PROVIDE ONE ONE-STOP INFORMATION FOR PEOPLE WHO ARE INTERESTED IN THOSE ISSUES AS A RESULT OF THE MAJOR COMMENT AARY AND THE ANNOUNCEMENT ABOUT THE POLICY IN DEFENSE DEPARTMENT. WE CERTAINLY ARE GAITH LOT MORE ATTENTION IT OUR WEBSITE. SO MY DIRECTOR'S PAGE IS THERE WHERE I BLOG ABOUT DIFFERENT ISSUES. HERE WE'RE HIGHLIGHT INGING A FEATURE CALLED "IN THE LAB." DIFFERENT INVESTIGATORS WHO ARE DOING THIS RESEARCH. AND I WANT /TO REALLY ACKNOWLEDGE THE INCREDIBLE HARD WORK FROM MANY INVESTIGATEORS WHO HAVE BEEN DOING THIS FOR YEARS. IT IS NOT A NEW THING. IF IT WASN'T BETTER TO ALL OF YOUR HARD WORK, WE WOULDN'T BE HERE AND THIS GIVES ME AN OPPORTUNITY TO HIGHLIGHT THE WORK BEING DONE. WE'VE EXPANDED THE CONTINUING EDUCATION CREDITS AVAILABLE FOR THOSE. PARTICULAR ARTICLES WE WANT /TO /SKPHAOEULT SECTION ON HISTORY AND INCLUSION AS PART OF THE HISTORY OF THE OFFICE AND ONE OF THE REASONS WHY WE'RE DOING THIS THIS. HERE I AM GOING TO ASK YOU TO RECORD THESE DATES ON YOUR CALENDAR. AGAIN, OCTOBER 20TH DATE FOR THE METHOD AND TECHNIQUES FOR ON A AVATING SECTION AND PRECLINICAL RESEARCH WORKSHOP. DR. MYERS, DID YOU MENTION EVERYTHING YOU NEEDED TO MENTION MENTION? IS THERE SOMETHING YOU'D LIKE TO ADD? >> IT WILL BE HELD ON CAMPUS. AND IT WILL BE IN THE PORTER SCIENCE BUILDING, THE NEW BUILDING. I CAN ADD MORE OR I CAN ADD MORE AT THE END. WHATEVER YOU PREFER. NOW? OKAY SO A BRIEF INTRO ABOUT WHAT WE CALL THE METHODS WORKSHOP. VERY FONDLY HERE IN THE OFFICE OF RESEARCH AND WOMEN'S HEALTH, I'VE EXPRESSED A LITTLE BIT TO YOU ABOUT WHAT IT'S BALL. REALLY, THE PURPOSE OF THIS MEETING IS TO BRING TOGETHER EXPERTS IN THE FIELD TO SHARE THEIR INFORMATION AND KNOWLEDGE ABOUT HOW /TO ACTUALLY CONDUCT THIS TYPE OF RESEARCH. WHETHER IT'S PRIMARY SUBCULTURES OR ANIMAL RESEARCH, WHETHER IT'S SOME OTHER ASPECT TADATA AN /HREUALYTICS OR EXPERIMENTAL DESIGN. IT'S CRITICALLY IMPORTANT THAT WE UNDER THIS AND WE MAKE SURE THAT WE CONVEY THIS FOG TO THE PUBLIC, TO OTHER RESEARCHERS AND TO ANYONE WHO IS INTERESTED IN TAKING THIS MESSAGE AND PASSING IT ALONG AND HOPEFULLY USING IT IN THEIR OWN WORK. SO WE HAVE A REALLY BANG-UP SCHEDULE AND LIFETIME VERY INTERESTING PEOPLE WHO WILL BE COMING TO SPEAK TO US, A WIDE VARIETY OF PEOPLE FROM THE WORK WORKSHOP. WHAT WE HOPE TO DO IS THERE WILL BE A SIGNIFICANT AMOUNT OF PILOT IN THE WORKSHOPS IN DISCUSSION. SO DISCUSSION SPEAKERS WILL SPEAK AND THEN WE'LL HAVE TIME FOR DISCUSSION WITH THE AUDIENCE AND AMONG THE SPEAKERS. SO THERE IS A TUM OF TIME TO FACILITATE THIS TYPE OF INTER INTER/AOBACTION, TO SHARE KNOWLEDGE AND AGAIN TO MAKE /THE BEST PRODUCT WE CAN. AT THE END /-OF THE MEETING WE'RE GOING TO PULL IT ALL TOGETHER. WE'RE GOING TO COME UP WITH SOME RECOMMENDATIONS. YOU SAY WHAT KIND OF RECOMMENDATIONS, AND I SAY IT'S WIDE OPEN. WE NEED TO KNOW WHAT YOU THINK ABOUT THIS. WE NEED TO KNOW WHAT PEOPLE WANT TO DO. WHAT IS MISSING? WHAT DON'T YOU KNOW AND WHAT DO YOU NEED TO KNOW /TPHAURGT WE CAN HELP EXPAND UPON? WE ALSO HOPE TO DEVELOP A MESSAGING OR SOME TALKING POINTS OR AN HE WIELEVATOR SPEECH FOR YOU TO TAKE HOME BECAUSE WE UNDERSTAND THAT PEOPLE WHO WILL BE WATCHING MAY BE A LITTLE CONCESKEPTICAL. THEY'RE NOT SURE WHAT TO DO AND I WANT THEM TO GO TO THEIR COLLEAGUES AND SAY "HEY, I HEARD THIS REALLY COOL THING AND" GIVE THEM A 2-MINUTE HE WIELEVATOR SPEECH AND FOUND ANOTHER COHORT. WE DO HOPE THE SPEAKERS /SPRAEPBS INTEREST IN DEVELOPING MANUSCRIPTS AND SUBMITTING FOR PUBLICATIONS TO HIGHLIGHT THE ISSUES WERE BROUGHT UP AT THE MEETING. IN/EU[INDISCERNIBLE] [ANNOUNCE ER] >> THAT WAS NOT ME SPEAKING. LAUGHT[LAUGHTER] SO WE HOPE TO BE ABLE TO DEVELOP THAT PUBLICATION AND TO SEND IT OUT AND HOPEFULLY THIS WILL HELP US GENERATE SOME INTEREST, AGAIN MORE INTEREST IN WHAT'S GOING ON IN TERMS OF SEX DIFFERENCES. RESEARCH, THE INFERENCE ON HEALTH AND DISEASE AND THE NITTY OF GRITTY OF HOW /TO ACTUALLY DO THIS. SO THIS IS WHAT WE HOPE TO ACCOMPLISH AND THAT'S WHAT I WANTED TO SAY ABOUT THE METHODS WORKSHOP. >> DR., -- THANK YOU, DR. MY EER. I AM SO EXCITED ABOUT THIS AND WE LITERAL LY JUST GOT APPROVAL FOR IT AND SO HELP US TO GET /* THE WORD OUT ON THAT TO FORWARD TO OUR COLLEAGUES. ONE OF THE BIGGEST QUESTIONS IS ABOUT THE NUMBER OF ANIMALS, WHAT APPROACHES CAN BE TAKEN. JUST PARSING THE DATA BY SEX AND YOU'RE NOT PARSEING THAT DATA THAT WAY, IT GIVES A FIRST LOOK OF ADAPTIVE DESIGN CAN ACTUALLY REDUCE THE NUMBER OF ANIMALS THAT YOU MIGHT USE. AND CAN ACTUALLY SHORTEN YOUR EXPERIMENTAL PERIOD IN CERTAIN CASES -- CASES BUT THAT INFORMATION ISN'T WIDELY /SKPHAURD WE DO THINK AND RECOGNIZE THAT IN ORDER TO TRANSFORM THE WAY SCIENCE IS DONE, IT'S REALLY IMPORTANT FOR US TO HELP SHARE SO THAT SCIENTISTS UNDERSTAND WHAT BOTH THE BENEFITS AND THE METHODS FOR HOW TO DO THIS. DIFFERENCE S S IN RESEARCH AND HOW TO INCLUDE /STOEUFDZ BOTH SEXES. AND WHEN SHE COMES BACK, WE'LL BE REALIZATION OUR FOURTH EDITION OF THE "WOMEN OF COLOR" HEALTH /TKADATA BOOK IN OCTOBER. WE'RE AS EXCITED ABOUT THIS AS ANYTHING ELSE. IT WILL BE RELEASED AS AN /AEBOOK AND THE REASON FOR THIS BOOK WHICH INCLUDES DATA SEGREGATED BY SEX AND GENDER IS THAT IT IS VERY DIFFICULT TO FIND DATA THAT IS SEGREGATED IN THAT WAY. OFTEN IT'S ONE OR THE OTHER. SO YOU CAN SEE THE /TAEDATA FIRST BY SEX OR BY RACE BUT YOU CAN'T SEE IT BROKEN OUT BY BOTH. SO IT'S HARD TO SEE. WHAT IS THE SITUATION FOR AFRICAN-AMERICAN WOMEN AND ASIAN AMERICAN WOMEN? WE KNOW, FOR EXAMPLE, THE LEADING CAUSES OF DEATH ARE DIFFERENT THAT'S THE /PWOPBOTTOM LINE. ALL WOMEN ARE NOT THE SAME. AND SO THIS BOOK WILL PROVIDE A WIDE VARIETY OF DATA ON WOMEN OF COLOR THAT'S HELPFUL TO THEIR CLINICIANS AND INVESTIGATORS. AND THEN IN NOVEMBER,'S MENTION MENTIONED, WE'LL BE HAVING OUR ANNUAL CONFERENCE SEX DIFFERENCE DIFFERENCES RESEARCH SIM /POYMPOSIUM WITH A FOCUS ON METHODS AND THE DOCTOR WILL BE OUR KEY KEYNOTE SPEAKER. SO THAT WILL BE LIVE BY VIDEO CAST. SHIFTING TO THE LEFT, ELEMENT IN OUR MISSION HERE. I WANT TO SHARE WITH YOU JUST A FEW THINGS ABOUT PROGRESS THAT WE HAVE MADE. CONTINUE TO CO-CHAIR THE WOMEN'S GROUP ON BIOMEDICAL AND WORKING CAREERS WITH DR. COLLINS AND ONE OF THE ACTIVITIES FROM ONE OF THE COMMITTEES THAT'S CALLED RESEARCH IN EVIDENCE ON WOMEN AND CAREERS IS /THE RESULT OF THE PIS INVESTORS WHO HAVE BEEN FUNDED. THERE WAS AN RFA ENTITLED CULTURAL FACTORS AND INTER INTERVENTION FOR WOMEN IN BIO BIOMEDICAL CAREERS ADMINISTERED BY N /KWREIG MS AND MULTIPLE INSTITUTES AND CENTERS, AND THEY WERE LOOKING AT THE FACTORS THAT ARE ASSOCIATED WITH WOMEN MOVING FORWARD OR NOT AND ASSESSING MENT /OORING INTERVENTIONS AND OTHERS. SOME OF THE KEY THINGS THAT COME OUT OF THAT GROUP INCLUDE THE IMPORTANCE OF SENIOR LEADERSHIP SUPPORT FOR WOMEN AND CAREER ADVANCEMENT AND WE'RE TALKING HIRING BUT WE'RE ALSO TALKING SPONSORSHIP. WE'RE DOG -- TALKING BEYOND /PHERPBT OGING IN TERMS OF AWARDS AND PROMOTIONS AND THESE OTHER FACTORS THAT ARE REALLY IMPORTANT FOR WOMEN TO MOVE AHEAD. WE TALKED ABOUT AND EVIDENCE WAS PROVIDED THE FACT THAT -- BUT IT CAN BE MEASURED AND IMPORTY IT CAN BE CHANGED. CULTURE CAME UP AND HAS BEEN PUBLISHED FROM THIS GROUP ABOUT THE IMPORTANCE OF CAREER SATISFACTION ON PERFORMANCE. SO A LINK BETWEEN SATISFACTION AND PERFORMANCE, WHICH IS A SNACENARIO OF PARTICULAR FOCUS AND THE TASK. BUT AGAIN CULTURE CAN BE MEASURED. VALID /A*ATED MEASUREMENTS FOR MEASURING CULTURE AND IT CAN BE CHANGE. A LITTLE BIT HARD TO CHANGE CULTURE BUT IT CAN BE DONE THE FACT THAT MENT /OORING NETWORKS ARE MORE EFFECT /KWREUIVE THAN MENTOR MENTORING DIETS FOR SOME SITUATION /SKPUZ BEARD WITH THE PENDING ANNOUNCEMENT OF THE NATIONAL RESEARCH ON MENT /OORING NETWORKS THAT WILL BE COMING OUT SOON. SO WE'RE EXCITED ABOUT THAT. AND ANOTHER CONCERNING POINT IS THAT INSTITUTIONAL FLEXIBILITY POLICIES ARE UNDERRECOGNIZED IN GENERAL AND UNDERUTILIZED. IN PART DUE TO ACADEMIC CULTURE AND IN SOME CASES A LACK OF VIABLE LEADERSHIP. SO JUST BECAUSE I POLICY EXISTS DOESN'T MEAN THAT IT'S BEING USED AND THERE ARE OTHER FACTORS THAT ARE CONTRIBUTING ACTUALLY TO BOTH MEN AND WOMEN, NOT TAKING ADVANTAGE OF THESE POLICY POLICIES. SO AGAIN, WE'RE TALKING ABOUT IN TERMS OF THE POLICY DOESN'T ACHIEVE THE INTENDED OBJECTIVE, THE POLICY IS REALLY USELESS AND SO WE'RE KIND OF LOOKING BEYOND THE POLICY, WHETHER -- WHAT ARE WE GETTING AND MANNERING THAT? ALSO, PARTICULARLY EXCITED TO TELL YOU THAT THESE PIS HAVE ALREADY PUT OUT GREAT PUBLISH PUBLICATIONS. IT WAS UN/PRPRECEDENTED FOR NIH SUPPORT THIS TYPE OF RESEARCH. SO WE ARE EXCITED ABOUT THIS GROUP AND CONTINUING TO WORK WITH THESE PIS IN PARTNERSHIP. AND I WANT TO HIGHLIGHT FOR YOU ANOTHER ACTIVITY OF THE WORKING GROUP ON WOMEN IN BIOMEDICAL CAREERS. THE WOMEN OF COLOR RESEARCH NETWORK, WHICH IS AN ONLINE PLATFORM, A SOCIAL IMMEDIAMEDIA SITE FOR EVERYONE INTERESTED NEXT PANDING DIVERSITY IN /AEA SCIENTIFIC WORK FORCE. PARTICULAR FOCUS ON WOMEN OF COLOR AND INTER/AOBACTION AND COLLABORATION. AMONGST INVESTIGATORS AND SCIENTISTS AND STUDENTS AND POLICYMAKERS, PROVIDE INFORMATION THAT HELPS US IN ANY WAY IN SCIENCE BUT ABSTRACT IS THERE. WE HIGHLIGHT PARTICULAR SCIENTIST AND WE'RE OVER 1400 MEMBERS. SO WE'RE EXCITED ABOUT THIS. AND WE'D LIKE YOU TO HELP US GET THE WORD OUT ABOUT THAT AS WELL. WE'RE COMING UP AN -- ON OUR HALF WWAY MARK FOR IMPLEMENTATION OF THE STRATEGIC PLAN FOR RESEARCH AND WOMEN'S HEALTH. AND I WANT TO REMIND US ALL OF THE SESSION DIFFERENCES AND RESEARCH AND BASIC SCIENCE STUDIES. THESE ARE NOT IN /TPHANY PRIORITY OF ORDER. IN/KRORCORPORATE S DESIGN APPLICATIONS AND WE'RE TRYING GONPARTNER WITH OUR FDA COLLEAGUES AND YOU WILL HEAR FROM DR. BOWL LATER IN /AA PRESENTATION BUT WE'RE PARTNERING OBROADLY WITH THE FDA TO SEE WHAT WE CAN TO IN TERMS OF SHARING OUR KNOWLEDGE BASE AND APPROACHES TO DEVICES AND OTHER TECHNOLOGY. PERSONALIZED HEALTH FOR GIRLS AND WOMEN AND THIS IS MY FAVORITE OBJECT OBJECTIVE BECAUSE THIS IS THE BOTTOM LINE. EVERYTHING ELSE SHOULD BE FEED ING TO ING ING TO THAT. CREATING STRATEGIC APPLIANCES DASH LICENSES AND PARTNERSHIPS, CRITICALLY IMPORTANT TO MAXIMIZE OUR DOMESTIC IM/PABPACT AND GLOBAL IM/PABPACT AND THAT LEARNING GOES BOTH WAYS WAYS. WE LEARN FROM OUR COLLEAGUES A ABROAD. WE WORK TOGETHER TO SHARE INFORMATION, AND WE PARTNER WITH A FEW ACTIVITIES IN THAT AREA. SO DEVELOPMENT NEW COMMUNICATION COMMUNICATIONS AND STRATEGIES DATE AND OF COURSE TO EMPLOY ONS ONINNOVATIVE STRATEGIES TO BUILD A WELL-TRAINED,, DIVERSE, AND RIG RIGOROUS WOMEN'S HEALTH RESEARCH WORK FORCE. SO HERE IS WHERE WE ARE NOW. WE ARE SEEKING TO INTENTIONALLY AND PURPOSEFULLY CONNECT THE DOTS IN THE RESEARCH CONTINUUM SO THAT SEX AND GENDER IS CONSIDERED THROUGHOUT THE ENTIRE RESEARCH CONTINUUM BUT ALSO AT THE HANDOFF. THOSE OF YOU WHO ARE CLINICIANS KNOW THE HANDOFF, THE CHECKOUT IS REALLY IMPORTANT. WHEN YOU'VE BEEN ON CALL ALL NIGHT AND A NEW PERSON COMES ON, YOU NEED TO LET THEM KNOW WHAT ARE THE KEY FACTOR THAT THEY NEED TO BE LOOKING STORE THAT THEY KNOW OH, THE /SPHRAORBS BACK AT 10. I CAN START ANTIBIOTICS ON THIS PATIENT BY 10:15. IF YOU DON'T TELL THE PERSON THAT, AND SEX OUTCOME. SO THE HANDOFF HAS TO BE IDENTIFIED IN PATIENT SAFETY A A/RAOERENA AS THE CLINICAL -- CRITIC CRITICAL POINT FOR PREVENTING ER ERRORS AND TRANSLATING INFORMATION IN THE MOST EFFECT EFFECTIVE WAY. SO WE'VE GOT FOLKS THAT ARE WORKING HERE, WE'RE WORKING HERE HERE. WE WANT TO BE ABLE TO PROMOTE THAT CHECKING OF THE DOTS IN /TH THIS CONTEXT. SO WITH A QUOTE FROM HELEN KEL KELLER. MOST OF YOU KNOW THAT I AM AN THAT WILMOLOGIST AND THE VISION THAT WE SEE AND WE USE THAT TERM IN A LOT /OF DIFFERENT WAYS. IT HAS BEEN EXTREMELY REWARDING TO BE ABLE TO EFFECT A FEW DECISIONS. IT'S MOST -- ONE OF THE MOST GRATIFYING PARTS OF BEING A FIZZ /KWHREUGS THIS IS THAT NEXT DAY IS FOR PEOPLE TO DO THINGS THAT THEY HADN'T SEEN FIRE LONG TIME pOR EVER AND SO HELEN KELLER, EVEN THOUGH SHE COULD NOT SEE AND SHE COULD NOT HEAR, SHE WAS VERY QUIESCENT IN HER REMARKS. ND I THINK AS WE GO FORWARD IN ""TOGETHER WE CAN DO SO MUCH". OUR EFFORTS WITH YOUR NBI, IT REALLY WILL BE IN PARTNERSHIP WITH EACH AND EVERY ONE /OF YOU AND WITH ALL OF THE /STPAEUBG -- STAKEHOLDERS IN THE SCIENTIFIC, BIOMEDICAL RESEARCH WORK FORCE ENTERPRISE THAT WAY WE CAN ACHIEVE OUR GOAL. THANKS SO MUCH FOR YOUR /THAEPBGS. I'LL BE HAPPY TO TAKE QUESTIONS ON THIS OR ANY OTHER TOPIC. >> THANK YOU, JANINE. IT WAS AN EXCELLENT AND HE WIELEGANT PRESENTATION. BUT I DO HAVE A QUESTION ABOUT THE THIRD PART OF THE MISSION, WHICH IS THE WORK FORCE DEVELOPMENT AND WOMEN'S HEALTH RESEARCH. I FEEL LIKE THE CLINICAL PARTNER OF THE INITIATIVE IN ADDING TO PRECLINICAL STEPS AND SEX DIFFERENCES AND KEEPING PEOPLE IN THE FIELD. I CAN TELL YOU IN THE BIRCH PROGRAM THAT WE HAVE DEFINITELY HAD AT LEAST PROBABLY A QUARTER TO A THIRD OF OUR FIRST SCHOLARS GO INTO THE FIELD OF WOMEN'S HEALTH BECAUSE THERE WAS A PROGRAM AND THEY DISCOVERED THE EXCITEMENT OF WOMEN'S HEALTH WHILE DOING RESEARCH, WHICH HOOS THAT WORK FORCE WOULDN'T HAVE AN DEVELOPED. AND STILL WOMEN'S HEALTH IS STILL PRETTY NEW AND I WOULD SAY -- WE NEED, I THINK, TO EN ENCOURAGE PEOPLE TO BECOME PART OF THAT WORK FORCE, BOTH MEN AND WOMEN IN THE FIELD AND I WORRY ABOUT THE BIRCH, JUST BEING ENORMOUS CHANGES SHE WASN'T EVEN THINKING ABOUT WOMEN'S HEALTH AND NOW SHE'S A BIRCH SCHOLAR AND ON THAT TRACK OF SEEING WHY GLUCOSE IS MORE PREVALENT IN WOMEN. SO I AM WORRYING ABOUT THE DEVELOPMENT OF THAT WORK FORCE SUCH AS THE BIRCH. >> JUDY, I AM HEARING THE LAST THING YOU SAID WAS DEEMPHASIZE AND I WANT TO MAKE SURE I CONVEY THAT FROM OUR PERCESPECTIVE WE ARE NOT THE -- DEEMPHASIZING CAREER DEVELOPMENT. WE'RE NOT DEEMPHASIZING BIO BIOMEDICAL DEVELOPMENT OF THE WORK FORCE. ONE /OF OUR /TKPWOEFLZ OUR STRATEGIC PLAN. HOW WE DO THAT NEED TO BE INFORMED BY DATA AND EVIDENCE AND WE NEED TO DO THINGS THAT ARE MOST EFFECT /KWREUIVE IN THE CURRENT ENVIRONMENT. DR. MONTGOMERY RICE HAS JOINED US. SEVERAL OF YOU KNOW IN THE ACADEMIC ENVIRONMENT, IT'S A NEW DAY YOU -- THE CONSTRAINTS RIN CREDIBLE. WHAT IS THE BEST WAY FOR US TO DO THAT? IS IT A BROAD, INSTITUTIONAL A APPROACH? /SWREUPBLG APPROACH? WHAT HAVE WE LEARNED FROM THE BIRCH? WHAT ARE THE KEY ELEMENT THAT ARE IMPORTANT? TIMING IN TERMS OF FACULTY DEVELOPMENT? WHERE IS THE SWEET SPOT THERE BECAUSE WE KNOW THAT TRANSITION -- WE LOSE PEOPLE AFTER -- WE GET THAT ASSOCIATE PROFESSOR BUT THAT'S A TOUGH SPOT, ESPECIALLY IN THE CURRENT FUNDING ENVIRONMENT. SO LET ME ASSURE THAT YOU WE ARE NOT DEEMPHASIZEING THAT. THAT IS CRITICALLY IMPORTANT TO HAVE WOMEN'S HEALTH RESEARCHERS OUT THERE. WE WOULD LOVE TO HAVE AS MANY PEOPLE AS POSSIBLE UNDERSTAND THE EFFECT OF SEX AND GENDER AND HEALTH AND DISEASE AND THAT DOESN'T TAKE AWAY FROM THE FACT THAT FROM OUR PERCESPECTIVE, BECAUSE WE HAVEN'T HAD THAT A APPROACH, WE HAVE GAPS IN OUR UNDERSTANDING ABOUT FEMALE BIOLOGY WE HAVE GAPS THAT'S NOT GOING TO BE FILLED OVERNIGHT WE NEED THE BROADER SCIENTIFIC COMMUNITY AS POSSIBLE TO HELP US FILL THAT GAP. THAT'S HIGH-SEE US TOGETHER. IT'S NOT AN EITHER/OR THING. IT'S A BOTH/AND THING. ALREADY CIONS ON ALL YOUR TERRIFIC WORK. WHEN I TALK TO COLLEAGUES WHO ARE NOT IN THE FIELD OR TO THE IMMEDIAMEDIA, THEY ALWAYS GET SO CONFUSED BY THE DIFFERENCES BETWEEN THE SEX AND GENDER. AND I KNOW THERE IS A CONTROVERSIAL THING TO SAY BUT SOMETIMES I WONDER IF WE'RE NOT DOING OURSELVES A DISSERVICE BY MAKING IT TO COMPLICATED IN IN INSIXTH ON USING THESE TWO TERMS INSTEAD OF ONE AND I'M JUST CURIOUS ABOUT YOUR THOUGHTS. ALREADY YOU KNOW, THAT'S AN IMPORTANT POINT AND WE'RE FOCUSEDING IN TERMS OF THE POLICY ON SEX IN PRECLINICAL RESEARCH. SO THAT'S WHY WE'RE USING THE TERM "SEX." BUT YOU HIGHLIGHT SOMETHING THAT I THINK ALL OF US DO COME ACROSS ACROSS. SOME PEOPLE FOR THE MOST PART SAY GENDER BECAUSE THEY DON'T REALLY MEAN SEX. AND SOMETIMES IT'S BLURRY BECAUSE -- SEX AND GENDER. >> RIGHT. >> PICK A WORD. >> BUT THEY ARE IN/EBGS /TREUEX/TREUBGTRI CABLE LY ENTANGLED, SEX AND /SKWHREPBD ER H AND SO WHAT HIOFTEN DO IS I USE SEX/GEND NER WRITTEN VERSION VERSIONS. BUT IT'S AN IMPORTANT POINT THAT YOU ARE RAISING. I DON'T KNOW THAT ONE COLLAPSING INTO ONE WOULD BE THE WAY TO GO. DID YOU HAVE A PARTICULAR TERM? >> GENDER BECAUSE SEX HAS ANOTHER MEANING. AND IF WE BROADEN THE USE OF IT, COULD COVER IT ALL? >> OKAY. >> PARTICULARLY NOW THAT THIS IS GOING TO BE SO TALKED ABOUT IN THE IMMEDIAMEDIA, TO OUR AUDIENCES. PEOPLE GET SO STUCK ON SOMETHING THAT'S NOT IMPORTANT. >> I HEAR YOU. DR. DEV -- LEVINE? >> SO I AM REALLY EXCITED ABOUT THE REFOCUSING ON GENDER. >> YES. >> I HAVE A QUESTION THAT IS RELATED TO FOCUS, PARTNERSHIP AND GLOBAL IN TERMS OF OUR STRATEGIC GOALS SO I STILL AM NOT SEEING -- WONDERFUL FOCUS ON WOMEN OF COLOR. BUT I AM NOT SEEING A VERY ADDRESSED GROUP AND THAT IS THE REFUGEES AND IMMIGRANTS AND I'D LIKE YOU TO JUST ADDRESS THAT. AND ON PARTNERSHIPS, ONE GROUP THAT HAS DONE A LOT /OF WORK ON WOMEN'S HEALTH IS /THE /TPHARBNATIONAL INSTITUTE OF RESEARCH AND ILLEGAL LOOK NOR SOME EVIDENCE WE COULD /SPHRUPLT RELATED TO THAT AND IT'S NOT THERE AND IT'S NOT THERE, WHICH IS MY NEXT ISSUE. IT IS ABOUT -- AND I'M SO GLAD YOU MENTIONED WOMEN IN GROUPS AND AREAS AND THAT'S SO MUCH FOR US TO LEARN FROM WOMEN'S HEALTH AND OTHER OTHERS. -- AREAS. BUT I AM NOT SEEING THAT THIS IS TRANSLATED IN TERMS OF THE PARTNERSHIP AND IN TERMS OF SOME OF THE ASSOCIATE BEING SUPPORTED SUPPORTED. {}AS ALWAYS, YOU BRING UP REALLY IMPORTANT ISSUES AND I WAS GOING TO TALK ABOUT THAT. I HAD FORGOTTEN ABOUT IT. IT'S VERY IMPORTANT TO US. SO LET ME REASSURE YOU THERE AND IN OUR -- IN THE STRATEGIC PLAN AND IN OUR PROCESS, WE HAD A SPECIFIC SESSION, AS YOU RECALL, ON UNDERSERVED AND UNDER UNDERSTUDIED WOMEN, WHICH INCLUDED WOMEN FOR WOMEN ENGLISH IS NOT A FIRST LANGUAGE, INCARC INCARCERATED WOMEN. WE HAD A PARTICULAR FOCUS ON THAT AND THERE IS A REPORT FROM THAT PARTICULAR GROUP THAT HELPS TO GUIDE OUR EFFORTS IN /THIS A A/RAOERENA. WE ARE PARTICULARLY INTERESTED IN SOME SPECIFIC HEALTH ISSUES THAT ARE MORE PREVALENT IN WOMEN FROM VARIOUS INTERNATIONAL LOCATIONS, INCLUDING A VARIETY OF CONDITIONS AND SO WHILE BOTH WERE NOT HIGHLIGHTED IN MY PRESENTATION TODAY, THEY ARE HAPPENING. SOME OF THEM ARE IN EARLIER STAGES, IN SCIENTIFIC PARTNER PARTNERSHIP AND REALLY THAT'S KIND OF MY MODUS OP/RAPBERANDI RIGHT NOW. IT'S FOR US TO GO TO THEM AND BE FULL SCIENTIFIC PARTNERS BECAUSE THEY CERTAINLY HAVE A LOT THERE THAN WE DO.^ BUT WE BRING A SCIENTIFIC VALUE ADDED PERCENT PERSPECTIVE THAT THEY DON'T NECESSARILY HAVE. SO NINR AGAIN, OF COURSE, I WAS WONDERING ABOUT WORKING WITH THEM IN /AA PARTICULAR AREA RELATED TO THE TOP /KWREUIC DR. COLLINS MENTIONED THAT HE WAS LEAVING TO GO TO SPEAK ON. GROIN YOU SAW A PIECE -- I THINK IN THE /TPHAO*EUPLS -- ON THE SEX -- ON THE NURSE THAT'S RIGHT TAKING CARE OF PATIENTS WITH O-- E/PWBOLA AND THE YOUNG MEN WHO ARE BEARING THE PATIENT AND THE FACT THAT IT IS HAVING A DIFFERENTIAL IM/PABPACT ON FEMALES AND MALES AND A COMPLETE LACK OF DATA ON CLINICAL COURSE THAT MIGHT BE DIFFERENT WE JUST DON'T HAVE THE DATA AND SO NINR WOULD BE AN OBVIOUS PARTNER. WE'VE HAD LONG TERM INTEREST IN CARE GIVING, AND ITS PARTICULAR EFFECT ON WOMEN. AND YOU KNOW, WOMEN ARE THE CARE CAREGIVERS, WE ARE. AND DESPITE THE FACT THAT WE DO HAVE MAJOR MEDICAL ADVANCES, WE STILL HAVE CHRONIC DISABILITY AS AN ISSUE. WOMEN LIVE LONGER THAN MEN, BUT WE LIVE MORE DISABLED YEARS THAN MEN. SO THE QUALITY OF LIFE ISSUE. LONGEVITY IS AN ISSUE. SO I COULDN'T FIT THEM ALL IN THAT PRESENTATION BUT I APPRECIATE YOU BRING THEM AGAIN TO THE COMMITTEE'S ATTENTION AS AN AREA THAT YOU'VE IDENTIFIED AS IMPORTANT TO YOU. OKAY. JOHN AND WE'LL GO UP THIS WAY, OKAY? >> I WANT TO START OFF BY SAYING I AM THRILLED. I AM ABSOLUTELY THRILLED WITH THE NEW POLICY BEING DEVELOPED WITH REGARD TO BASIC SCIENCE RESEARCH. AS A LOT /OF YOU HAVE HEARD ME SAY OAF THE YEARS BASIC SCIENCES HAVE BEEN IN THE STONE AGES COMPARED TO CLINICAL SCIENCE IN TERMS OF REPRESENTING AND TACK TACKLING SEX AND GEND NER RESEARCH. SO I WANT TO CONGRATULATE AND FROM ALL OF US I'M LOOKING AT JILL AND A FEW OTHERS AROUND /THE TABLE AND ALL SCIENTISTS WHO EARLY ON IDENTIFIED THIS PARTICULARLY AS /AA PROBLEM BE IN BEHAVIORAL AND FIPHYSIO/HROPBLLOGICAL RESEARCH. I DO NOW WANT /TO TAKE OFF ANY -- MY HAT AS AN AN ONLY PROPONENT OF GETTING THIS INTO THE REVIEW PROCESS. AND PUT ON MY HAT AS /AA RESEARCH WHO IS AMONG HEARING SOME OF MY COLLEAGUES BEING REPORTED AS CRUMBLING -- -- GRUMBLING AND BEING RESIST AANT. THERE IS A CONCERN THAT I WOULD LIKE TO THAT, ALTHOUGH I WAS A PROPONENT AND REALLY WAS PUSHING FOR THE REVIEW PROCESS AT NIH TO BE CHANGED TO FEDERAL GOVERNMEOSTER A NEW NINR BASIC SCIENCE RESEARCH, THERE IS A LOT /OF FEAR THAT IT'S GOING TO BE APPLIED IN/TKREUS /KREUDISCRIMINANTLY A ND UNINTENDED CONSEQUENCES. IT'S NOT JUST -- I'M SURE THAT THERE ARE SOME THAT ARE REACTION ARY AND JUST DON'T WANT TO BE TOLD HOW TO DO THEIR RESEARCH. I WOULD MAINTAIN IT'S A SMALLER NUMBER THAN PEOPLE MIGHT THINK. AND I KNOW THAT A LOT /OF PEOPLE ARE CONCERNED ABOUT THE COST OF PROJECTS AND HOW IT IMPACTS THEIR DESIGN AND THEIR STUDIES I THINK IT'S GLIM TO SAY THAT IT'S NOT GOING OGLIB TO SAY THAT IT'S NOT GOING TO COST THAT MUCH MORE MORE, IF YOU REALLY THINK ABOUT IT, BECAUSE FROM THE PERCESPECTIVE HISTORY SCIENTIST THAT ARE PROPOSING THE STUDIES, IT DOESN'T LOOK THAT WAY. I DO THINK THAT THERE SHOULD BE CAUTION IN THE PROCESS OF DEVELOPING THE, THAT THERE IS SUFFICIENT PUBLIC ADDRESSING OF THE CONCERN THAT THERE IS LIMIT LIMITED RESOURCES IN CERTAIN AREAS AND I'LL GIVE THE EXAMPLE OF NON-HUMAN PRIMARY RESEARCH. WHEN MY COLLEAGUES AT THE OTHER PRIMATE CENTERS FIRST READ ABOUT THIS, THEY WERE VERY, VERY CONCERNED AND REMAIN CONCERNED THAT WE DON'T HAVE THE RESOURCES IN TERMS OF EVEN NUMBERS OF AN ANIMALS TO ACCOMMODATE ESSENTIALLY A MANDATE OF IN INCREASING THE PARITY IN THE SUBJECTS IN CERTAIN STUDIES. I'VE TRIED /TO TELL THEM THAT THAT WON'T HAPPEN, THAT THIS IS BEING IMPLEMENTED AND DEVISED IN A VERY INTELLIGENT WAY THAT TAKES INTO ACCOUNT -- I'M NOT GETTING VERY FAR. AND I CAN SEE WE HAVE 26,000 AN ANIMALS IN /AA PRIMATE CENTER SYSTEM, AND FEMALES DISPRO DISPROPORTIONATE LY ARE THE BREED BREEDING COLONY, WITHIN OUR OWN PORT /TPOFOLIO, WE HAVE FEMALES DED DEDICATED TO P /KR-FPCOS PROJECTS OR TRANSVAGINAL SIV INFECTION STUDY STUDY, LEAVING A SMALL NUMBER OF FEMALES THAT ARE ACTUALLY GOING TO BE TO BE AVAILABLE. AND THIS IS A REALTIME CONCERN AND IT'S AFFECTING HOW PEOPLE /R ARE DEVELOPING AND DESIGNING EXPERIMENTS RIGHT NOW. SO I WANT /TED TO MAKE /SHAOUSURE THAT YOU'RE AWARE IT'S NOT NEAR PANIC BUT THERE IS A LOT /OF REAL CONCERN OUT THERE THAT'S CHANGING THE WAY THAT RIGHT NOW EVEN BEFORE THE NEW POLICY IS IMPLEMENTED. AND I'LL SAY YES, WE WILL /BE SUBMITTING A STATEMENT TO THE RF RFI, DESCRIBING THIS. BUT I DID WANT /TO BLING IT UP AND ESPECIALLY IN /SPHOPBS TO THE IDEA THAT THERE IS A LOT /OF GRUMBLING BY BASIC SCIENTISTS AND PRESENT THE OTHER SIDE AFTER I'VE BEEN ON THIS SIDE FOR SO LONG. OH, I'M DEFINITELY STILL ON THIS SIDE. >> THANK YOU, JOHN. AND OF COURSE WE REALLY NEED YOU HERE FOR THAT AND THANK YOU FOR BRINGING IT UP FOR TODAY AS WELL WELL. THESE ARE COMPLICATED ISSUES. IF IT WAS EASY, IT WOULD HAVE BEEN DONE A LONG TIME AGO. IT'S CHALLENGING. IT'S DIFFICULT IT'S COMPLEX WE RECOGNIZE THAT. THERE ARE PARTICULAR SPECIES LIKE PRIMATES, THAT HAVE SPECIFIC CONCERNS /SKPWR-BGS ALSO PLAY A PARTICULARLY IMPORTANT ROLE IN TRANSLATION THAT NO OTHER -- WILL PLAY. THAT'S THE KIND OF THING THAT WILL IN/TPORFORM US DEVELOPING A -- APPROPRIATELY NUANCED TO TAKE THAT INTO CONSIDERATION AS WELL AS EVERY OTHER TYPE OF RESEARCH THAT NIH FUNDS AND ALL THE OTHER VERTEBRATE ANIMALS THAT ARE INVOLVED. THAT'S WHY WE WANT TO DO THIS IN A VERY THOUGHTFUL AND DELIBERATE WAY SO THAT WE DON'T HAVE UN UNINTENDED CONSEQUENCES THAT GO AGAINST WHAT WE WERE TRYING TO INTEND. THE WHOLE POINT WAS TO GET A DIFFERENT OBJECTIVE, NOT TO /TKWUFT DEVELOP A POLICY THAT SOMEBODY HAS TO CHECK OFF. WE'RE NOT INTERESTED IN THAT. AND SO THANKS FOR BRINGING THAT UP. WE ONLY HAVE FOUR MINUTES BEFORE OUR NEXT TALK AND I REALLY WANT TO STAY ON TIME SO EMRON HAD HIS HAND UP FIRST OR JOE? ARE YOU GOING TO SPEAK TO THE LOVELY LADIES HERE, RIGHT? YOU ARE ONLY GETTING ONE QUESTION YOU CAN PLEASE WRITE DOWN THE QUESTION BECAUSE WE HAVE DISCUSSION TIME BUILT IN, OKAY JILL, CAN YOU GO? >> THANK YOU. AND THIS SORT OF FOLLOWS UP ON JOHN'S QUESTION, SO IT'S RELATED RELATED. SO I HOPE IT WON'T TAKE TOO MUCH TIME. BUT AS /AA RESEARCHER WHO HAS BEEN DOING SEX DIFFERENCES IN THE BRAIN SINCE 1980 THERE ARE MANY FINDINGS THAT HAVE BEEN THROUGHOUT FOR SOMETIME THAT SIMPLY AREN'T MAKING IT INTO THE CCAL TRANSLATION SO I THOUGHT YOUR POINT ABOUT HANDING OFF AND MAKING FACILITY FACILITATING THE HANDOFF IS REALLY, REALLY IMPORTAN AND THAT AS WE THINK ABOUT THEM, WE SHOULD ALSO BE THINKING ABOUT HOW WE FACILITATE THE TRANS TRANSLATION OF THAT INFORMATION AND THE ABILITY OF CLINICAL RESEARCHERS TO TAKE AND USE WHAT WE'VE BEEN FINDING AT THE BASIC LEVEL IN /AA THOUGHTFUL WAY. SO I THINK THAT COULD BE ONE OF THE BIGGEST THINGS THAT COULD COME OUT OF THIS IS THAT WE BECOME MORE THOUGHTFUL ABOUT MAKING BASIC RESEARCH ACCESSIBLE TO THOSE WHO WANT TO USE IT. >> THANK YOU. THAT'S A VERY CONSTRUCT /KWREUIVE SUGGESTION. I APPRECIATE THAT. SO IN THE INTEREST OF TIME, WRITE DOWN YOUR QUESTIONS. WE'LL HAVE TIME AND WE'RE GOING TO GO TO OUR NEXT AGENDA ITEM, CORNELIUS IS GOING TO INTRODUCE. I BELIEVE? NO? HOLD ON ONE SECOND. APPRECIATE THAT. >> GOOD MORNING. I AM PLEASED TO BE ABLE TO INTRODUCE THIS MORNING ONE /OF OUR MOST DISTINGUISHED FDA COLLEAGUES, DR. KABUL. THE FIRST PERMANENT DIRECTOR OF THE OFFICE OF MINORITY HEALTH AT FDA. AFTER 12 YEARS IN VARIOUS POSITION THERE'S AND LEADERSHIP ROLES, SHE LEFT AT THE SHALL AND WENT TO WORK IN THE PRIVATE CENTER WITH NOVEMBER ART IS AND SERVED AS ASSISTANT CLINICAL PRO PROFESSOR AT GEORGE WASHINGTON UNIVERSITY, A POSITION SHE STILL HOLD N AUGUST OF 2012, SHE RETURNED TO THE FDA TO LEAD THE OFFICE OF MINORITY HEALTH AND AT THIS POINT I WOULD LUKE TO NOTE THAT THE FDA'S OFFICE OF WOMEN'S HEALTH RECENTLY CELEBRATED ITS 20TH ANNIVERSARY OF ENSURING SAFE AND EFFECTIVE HAD MEDICATIONS FOR WOMEN. AS FORMER ACT DIRECTOR OF THE OFFICE THE DOCTOR PLAYED AN IMPORTANT ROLE IN THE OFFICE'S WORK SO WE'RE VERY PLEASED TO HAVE HERE -- HER HERE TODAY. THANK YOU. /PHRA [APPLAUSE] >> ARE THANK YOU VERY MUCH FOR THAT KIND IN/SREVITATION TO BE HERE TODAY WITH YOU AND THAT INTRODUCTION I BRING A LONG- LONG-STANDING INTEREST INTO THE WORK OF THE OFFICE OF WOMEN'S HEALTH IN THAT OFFICE AS /AA DEPUTY OF RESEARCH AND AS THE DIRECTOR FOR RETURNING BACK TO MY ROOTS IN WEE VALUATION /WROEUFP AND THRILLED TO HAVE THE OPPORTUNITY TO RETURN TO THE AGENCY IN /AA NEW WAY UNDER /-THE AFFORDABLE /KAECARE ACT. SO WITHOUT FURTHER A/STKWROBGS A/STKWROBGSLET GET STARTED. THE ACT OF 2012 /STKWR-RGS FDA IN/EU[INDISCERNIBLE] THAT OPPORTUNITY WAS THERE ABOUT EFFORTS AND -- TO DO WHAT WE CALL WAS ADD-ON TO THIS LEGISLATION SO ONE OF THOSE ADD-ONS WAS SECTION VII ADDRESSING INCLUSION OF DEMOGRAPHIC SUBGROUPS IN TRIALS. TECHNICAL DIFFICULTY HERE. OKAY. >> THANK YOU. OKAY. THE PURPOSE OF THE DEFINITION. DEMOGRAPHIC SUBGROUP INDIVIDUALS OF BEARING SEX AGE, RACE AND ETH ETH/TPHENIS WRIT. SO I THINK IT'S IMPORTANT TO FRAMEWORK AROUND /THE HISTORY -- IN/EU[INDISCERNIBLE] I'LL TALK BRIEFLY ABOUT THE BIOLOGY, THE DATA AND CONCLUSION. AND THEN DETAIL ON THE ACTION PLAN THAT WAS BASED ON THE FINDINGS OF THAT REPORT INAUDIB[INAUDIBLE] CONSIDERATION. SO THE LEGISLATIVE HISTORY. AND THESE ARE GROUPS THAT I AM SURE AS STAKEHOLDERS INAUDIB[INAUDIBLE] WELCOME'S HEALTH, THE /PHERAMERICAN HEART ASSOCIATION HART, RESEARCH ON WOMEN'S HEALTH. THE LEGISLATION REQUIRES TO BAD LUCK LY REPORT DATA ON INCLUSION AND ANALYSIS OF WOMEN IN AP APPLICATIONS. SO A LEDGISLATIVE PACKAGE WHICH WAS AT THE HEART OF THE WOMEN'S ACT AND LEP /HA*BL. AND /AA PROVISION IN/EUP[INDISCERNIBLE] TO INCLUDE REPORTING WITH RACE AND ETH/TPHENICITY AND THIS IS INTO THAT 204 -- 20 2012 LEGISLATION ACT AND IT INCLUDED REQUIREMENT FOR AN INITIAL PUBLIC REPORT ON IN INCLUSION DATA APPLICATIONS MEDICAL PRODUCT APPLICATIONS, AS WELL AS THE DEVELOPMENT OF /AA SUB SUBSEQUENT ACTION PLAN TO ADDRESS THE -- IN/EU[INDISCERNIBLE] NOID IN THAT REPORT. SO TO TALK ABOUT -- TO ACKNOWLEDGE APE COLLEAGUE WHO IS NOW HERE AT NIH, WHO PLAYED A VERY SIMILAR ROLE THE DEVELOPMENT THAT HAVE REPORT AND SHE WAS SOCIAL -- CERTAINLY ONE. BUT THAT REPORT, THE REQUIREMENT UNDER /THE LEGISLATION, WITHIN ONE YEAR OF ENACT PROVIDE A COPY TO CONGRESS.^ A REPORT ON THE CLINICAL TRIAL PARTICIPATION AS WELL AS THE TO DETERMINE SAFETY AND EFFECT /KWREUIVENESS INCLUDED IN THAT APPLICATION TO FDA AS WELL AS THE ADD /KWEQUACY OF REGULATIONS FDA AND REQUIREMENT BUT -- INAUDIB[INAUDIBLE] WE OPERATE AS INAUDIB[INAUDIBLE] ENTITY AND ISSUES AROUND CONFIDENTIAL -- WOULD HAVE TO BE TAKEN INTO ACCOUNT. SO THE STATUTORY REQUIREMENT FOR 907. PUBLISH A REPORT. FDA WAS TO PUBLISH AN ACTION PLAN ON THE WEBSITE. THAT PROVIDES PUBLICATIONS TO CONGRESS. IT MUST INCLUDE TO IMPROVE THE COMPLETENESS AND QUALITY OF THEIR ANALYSES WITHIN A SUBGROUP SUBGROUP, INCLUDING SUMMARIES OF PRODUCT, SAFETY AND EFFECTIVE EFFECTIVENESS AND BIOLOGICAL SUPPORT AS WELL AS IMPLEMENTATION INCLUDED IN PRODUCT LABELING. WE ALSO WERE ASKED TO INAUDIBLE [INAUDIBLE] SAFETY DATA AS WELL AS RECOMMENDATIONS TO OTHERWISE IMPROVE THE PUBLIC AVAILABILITY OF AS MUCH TADATA. THE PATIENT, HEALTHCARE PROVIDERS AND RESEARCH TECHNOLOGISTPS THAT THEY PLAY IN OUR REVIEW OF THE DATA IN THESE APPLICATIONS. FROM THE PRECLINICAL TO THE CLINICAL AND HOW THAT INAUDIBLE [INAUDIBLE] DECISIONS BY HEALTHCARE PROVIDERS. SO TO TOUCH ON THE 907 REPORT AND THIS METHOLOGY, WE HAD AP APPLICATIONS FROM 2011. IT'S IMPORTANT FOR ME TO HIGHLIGHT THE DATASETS THAT A ALLOW US TO EASILY REVIEW THIS INFORMATION. THERE WERE 5 APPLICATIONS. 37. LOOKED AT PIVOTAL STUDIES ON DEM DEMOGRAPHIC DATA INAUDIBL[INAUDIBLE] FDA STATUTE, REGULATIONINGS AND POLICIES. WITH THEM PROVIDE A SOLID FRAMEWORK FOR PROVIDING DATA AND APPLICATIONS ON INCLUSION ANALYSIS AND DEMOGRAPHICS. SO WE HAVE A /TPRAEURG. THE QUESTION BECOMES -- FRAMEWORK. BUT WE ALSO FOUND GENERAL RESPONSES OF DESCRIBING THE DEM DEMOGRAPHIC PROFILES OF PARTICIPANTS. FROM AGE IN THE /PHAOEURPBLGT OF APCAYINGS SUBMIT TO THE AGENCY AGENCYING AND ANALYSES AND THAT THE AGENCY DOES SHARE THIS INFORMATION IN /AA VARIETY OF INAUDIB[INAUDIBLE] AS WELL AS REVIEW ON THE FDA WEBSITE. PATIENT'S AGE AND SEX TEND ED ED TO REFLECT -- INAUDIB[INAUDIBLE] AND PATIENT PARTICIPATION BY AGE AND SEX. AND I THINK THAT SOME PRODUCTS ARE IN/EU[INDISCERNIBLE] AND SO INAUDIB[INAUDIBLE]. FOUND THESE DEFINITIONS FOR LATINO AND NON-HISS /PAPANIC LATINO STUDIES AND IT'S IMPORTANT TO UNDERSTAND INAUDIB[INAUDIBLE] CARINGS OF MINORITY POPULATIONS CONSIDERATIONS OF MINORITY POPULATIONS THAT SUFFICIENT DATA WAS CORRECT TO USE THE ANALYSIS INAUDIB[INAUDIBLE] AND TO HIGHLIGHT WHAT'S GOING TO BE SAID. WE HAVE A FRAMEWORK. VUK A TABLE. YOU CAN HAVE A METHOD FOR CORRECT BUG IT DOESN'T INAUDIBLE [INAUDIBLE]. VUK A TABLE THAT OUTLINES ALL THE CATEGORIES INAUDIB[INAUDIBLE] ITSELF. SO THE PROCESS FOR DEVELOPING AN ACTION PLAN IS TO ENGAGE STAKE STAKEHOLD ER IN/PUPUT. THE REPORT WHICH WAS OPEN FROM AUGUST 20TH, 2013 TO INAUDIB[INAUDIBLE] OFFICE OF WOMEN'S HEALTH. AS WELL AS THE OFFICE OF HEALTH AND CONSTITUENTS. PUBLIC MEETING ON THE 1ST OF APRIL OF THIS /KWRAYEAR AS WELL AS CONVENING STAKEHOLD EER MEETINGS FOR ADDITIONAL IN/PPUT. HERE. PATIENT AND HEALTHCARE FOR MINORITIES AND ELDERLY-SPONSORED TRIALS IS NOT CONSISTENT WITH THE UNDERLYING POPULATION WE WERE TOLD DONE HAVE SUFFICIENT DEMOGRAPHIC INFORMATION TO MAKE WELL-INFORMED TREATMENT AND DIAGNOSTIC DECISION THE RATIO IN PARTICIPATION AND RELEVANCE CAN BE A PARTICULAR PROBLEM BECAUSE ONE OF THE /RAELTSZ WE FACE AT THE AGENCY IS THAT A LOT OF THE TADATA COME IN HOW'D HISTORY UNITED STATES. IT HAS COME FROM A GLOBAL DEVELOPMENT PROGRAM. CONCERNS WE HAVE FROM INDUSTRY. THAT -- INAUDIB[INAUDIBLE] ACCESS TO CLINICAL /TRAOEUTRIALS. AND INAUDIB[INAUDIBLE] GEOGRAPHIC REGIONS AND REPRESENTATIONS. YOU HAVE TO TAKE INTO ACCOUNT ACCOUNT EASTERN EUROPE IN REL RELEVANCE TO U.S. POPULATION. KENNEL CONCERN -- CONGRESSIONAL CONCERN THE DATA THIS -- INAUDIB[INAUDIBLE] THEY WANTED TO SEE SPECIFYING ACTION TAKEN WITH INDUSTRY. SO ANALYSES -- THAT'S MORE TRANS TRANSPARENT. SLOS WANTED TO HAVE TO BE INAUDIB[INAUDIBLE] THAT WOULD BE REGULATED AS WELL AS OPPORTUNITIES FOR FURTHER ACTION ACTIONS NEEDED SO THE ACTION PLAN. POSTED PUBLICLY THIS /KWRAYEAR. THREE OVERARCHING. THE FIRST COMPLETENESS OF TEM GRAPHICS DATA REQUIRED FOR ANALYSIS. THE SECOND ON PARTICIPATION AND BARRIERS IN CLINICAL /TRAOEUTRIALS AND IDENTIFY STRATEGIES TO ENCOURAGE GREATER PARTICIPATION. THE THIRD PRIORITY IS MAKE MORE RELEVANT AND TRANS/PAEURPPARENCY. SO FOR THE FIRST PRIORITY. WE IDENTIFIED ACTIONS THAT UNDER PRIORITIES. ONE THAT WE WOULD REVIEW. WE HAVE A FRAMEWORK THAT CLEARLY HAS SOME CHALLENGES IN HOW THESE ARE EXECUTED. WE DO WHAT WE'RE DOING IN PRYING -- PROVIDING TO INDUSTRY. AS WELL AS OUTREACH SO THAT WE HAVE THOSE IMPLEMENTATION. WORK WITH INDUSTRY PARTNERS TO ENHANCE INFORMATION AND AP APPLICATIONS. AS WELL AS ONGOING TRAINING SO THAT COMMUNICATION ARE DEEPLY EM EM/PWBEDDED /TPHRAUB[INAUDIBLE] AS SCIENTIFICALLY. ALSO OPPORTUNITIES FOR US TO ENHANCE THESE SYSTEMS FOR CORRECTING, ANALYZING, AND COMMUNICATING THE INFORMATION TO OPTIMIZE MEDICAL PRODUCTS IN DIVERSE POPULATIONS OVER /THE TOTAL PRODUCT LIFE CYCLE. SO LOOKING AT ISSUES IN THE PRE PRECLINICAL STAGE /STEUPBLG, CLINICAL /TRAOEUTRIALS AS WELL AS DATA COLLECTIONS AS THOSE PRESENT. AND FINALLY TO CONDUCT RESEARCH NABLE INAUDIBLE AND SPECIFIC AREA IS PUBLIC HEALTH CONCERN RELATED TO DEMOGRAPHIC INAUDIBLE [INAUDIBLE]. SUBGROUPS. IDENTIFY VARIOUS PERCESPECTIVE PRO PROSPECTIVE ENROLLMENT TO EN ENCOURAGE BROADER PARTICIPATION. ONE OF THE AREAS THAT WE KNOW IS CHALLENGING IS THAT WE REALLY DON'T KNOW -- THERE IS A LOT OF SPECULATEING RANGING FROM LACK OF TRUST IN THE RESEARCH IS THAT WE ARE A PART OF AND HOW CRITIC CRITICAL IS THAT IN OUR CURRENT ENVIRONMENT AND LOW PARTICIPATION. WE ACTUALLY WILL BE -- ONE /OF OUR ACTIONS INAUDIB[INAUDIBLE] DATA INAUDIB[INAUDIBLE] SO LOOKING AT WHAT ARE THE BARRIERS TO INCLUSION? IMPLEMENT EFFORT TO ENHANCE APPROPRIATE PROTOCOL. YOU CAN HAVE A PROT KOHL THAT HAS INCLUSION CRY /TAOITERIA BUT IN PRACTICE HOW DO WE KEEP CERTAIN PATIENTS OUT? ONE EXAMPLE THAT COMES TO MIND HEPATITIS DRUG PATIENTS INAUDIB[INAUDIBLE]. SO YOU REALLY HAVE TO LOOK CARE CAREFULLY. B /PH-FPMI LEVEL INAUDIBL[INAUDIBLE] POPUL ATIO POPULATION? AND AGE LIMITS AND DEFINITELY PUSHING VOTER FLEXIBILITY BECAUSE WITH AN AGING DEM DEMOGRAPHIC YOU NEED INFORMATION ABOUT THAT AGE GROUP INCREASE COLLABORATION WITH NIH AND OTHER STAKEHOLDERS TO BROAD BROADEN INAUDIB[INAUDIBLE] COMMITTING MORE EFFORT AS WELL AS THE ACADEMIC ENVIRONMENT INAUDIB[INAUDIBLE] ENGAGEMENT. AND FINALLY TO UTILIZE COMMUNICATION CHANNELS TO EN ENCOURAGE GROWTH AND PARTICIPATION. THIS IS AROUND COMMUNICATINGING THERE ARE PROTECTION S S IN PLACES AND INFORMED DECISION THAT'S PATIENTS CAN BE ASSURED THAT THERE ARE STEPS IN PLACE THAT ARE WORKING OUT FOR THEIR INTERESTS. MAKING DEMOGRAPHICS MORE AVAILABLE AND TRANSPARENT. WE ARE ACTIVELY WORKING TO DEVELOP A DATABASE THAT WOULD BE AVAILABLE TO THE PUBLICING, THAT WILL CREATE BETTER INAUDIB[INAUDIBLE] AROUND DEMOGRAPHIC COMPENSATION IN CLINICAL /TRAOEUTRIALS THAT FDA INAUDIB[INAUDIBLE] I CAN ASSURE YOU IT WILL BE SOON AND IT'S BEEN /SHRAEFL WORKED ON IDENTIFY EFFORTS TO COMMUNICATE INFORMATION FOR PRODUCT LABELING. ONE OF THE ISSUES RAISED BY STAKEHOLDERS WAS THAT WE HAVE SOME PRODUCT /HRAEUBLGZ THAT THAT AFFIRMATIVEIVELY STATE THAT NO DIFFERENCES WERE FOUND WHERE WHEREAS OTHERS SAY I -- THAT WILL BE SILENT AND DIFFERENT PHILOSOPHYS BECAUSE PRODUCT -- WE HAVE THERAPEUTIC AREAS WHO INAUDIBLE [INAUDIBLE] NE IT DOESN'T MEAN IT WASN'T LOOKED AT. WHEREAS OTHERS WERE COMMUNICATE COMMUNICATING INAUDIB[INAUDIBLE] ARE MORE AFFIRMATIVE THAT THEY LOOKED AT DIFFERENCESS SO WE'RE LOOKING TO MAKE THOSE PROCESSES IN THAT REGARD MORE CONSISTENT. IMPLEMENT COMMUNICATION STRATEGIES THAT ARE ESSENTIAL FOR UNDERREPRESENTED POPULATION S WIWAS A FOCUS TO ACCESS AS WELL AS HEALTH LIT /RERACY. HOW CAN WE MAKE THIS INFORMATION MORE ACCESSIBLE? WORKING TO ENSURE THAT NABLE INAUDIBLE RESEARCH AREAS HAS BEEN IN THE AREA OF HEALTH LIT /KWRIAS Y.^ LIT /RERACY. SO TWO THAT HAVE BEEN LOOKED AT AS FAR AS HEPATITIS C AND NABLE INAUDIB[INAUDIBLE] INAUDIBLE AND AN IN INFORMED AUDIENCE FROM A COLLEGE LEVEL. THAN THE AVERAGE AMERICAN. ESTABLISH AN INTERNAL FDA TO OVERSEE AND TRACK IMPLEMENTATION OF INAUDIB[INAUDIBLE] AS WELL AS AS WELL AS A PLAN IN AN FDA WORK WORKSHOP ON THE ACTION /TPHRAOUPB MONTHS AFTER WE POST. SO THAT'S UNDER REVIEW ALSO SO IN CLOSING, BENEFITS IN SCIENCE -- INAUDIB[INAUDIBLE] INCREASING LLY IMPORTANT WAY WAY IN HEALTH SYSTEMS BARRIERS INAUDIB[INAUDIBLE]. WE KNOW THAT THE INFORMATION IS DONE ON GENOMICS AND HOW WE HAVE /STPOEUD THE RIGHT INAUDIB[INAUDIBLE] AND HOW THAT INFLUENCED PRODUCT DEVELOPMENT WOULD HAVE TO BE TAKEN INTO ACCOUNT. ULTIMATE LY WE SEE THE TREATMENT TO INDIVIDUALS THROUGH PERSONAL PERSONALIZED MEDICINE, INCLUDING PATIENT AND UNDERSERVED AND UNDERREPRESENTED POPULATIONS WE HAVE A WEBSITE THAT WE HAVE THAT WILL BE UPDATED REGULARLY. AND HAD THANK YOU SO MUCH FOR THE OPPORTUNITY TO SHARE THIS WITH YOU THIS MORNING. /PHRA [APPLAUSE] >> SO WHAT ABOUT THIS ISSUE ABOUT SO MANY INDUSTRY TRIALS BEING CONDUCTED OVERSEAS AND THE CONCERNS ABOUT THE LACK OF GENERALIZEABILITY TO THE U.S. POPULATION? >> I THINK WHAT YOU HIGHLIGHTED IN THE SECOND PART OF YOUR QUESTION -- I THINK THE CONCERN OF GENERAL /AOEIZABILITY AND LOOKING AT ISSUES OF INAUDIB[INAUDIBLE] HERE IN THE COUNTRY I THINK THAT INAUDIB[INAUDIBLE] IN TERMS OF THE -- IT'S NOT SO MUCH AS GLOBAL TRIALS. IT'S HOW DO WE MAKE THAT DATA USEFUL TO THE U.S. POPULATIONS? INAUDIB[INAUDIBLE] AND THIS HAS TO BE MUCH MORE FORTH RIGHT ABOUT THE FOCUS OF DATA INAUDIBL[INAUDIBLE] AND THE REPORT IN THESE PRODUCTS. AND SO THE QUESTION THEN BECOMES HOW DO YOU ESTABLISH COM COMPARABILITY? HOW COMFORTABLE IS THAT CONTROL KEL FROM MY PERSONAL EXAMPLE INAUDIB[INAUDIBLE] AND HOW COMPARABLE IS HER CONTROL TO MY OBESE WOMAN WOMAN? >> SO WHY-JUST REQUIRE THAT MORE TRIALS BE DONE IN THE U.S.? >> I THINK THAT IN TERMS OF REQUIREMENTS, THERE ARE -- ONE OF THE QUESTIONS INAUDIB[INAUDIBLE] I THINK WE DO NEED CONTINUED CONVERSATION BECAUSE THERE ARE EXAMPLES INAUDIB[INAUDIBLE]. OTHERS WHERE IT MATTERS CRITIC CRITICALLY AND INAUDIB[INAUDIBLE] CONVERSATION PROBABLY ON A CASE CASE-BY-CASE BASIS. BECAUSE YOU DON'T WANT /TO INAUDIB[INAUDIBLE] TO DO CLINICAL TRIALS TO ASK THAT YOU DON'T NEED JUST FOR THE /SAEUSAKE OF SIG -- SAYING IT WAS DONE HERE. BUT YOU WANT /TTO ENSURE THE DATA THAT YOU HAVE IS RELEVANT TO THE POPULATION THAT'S WE SERVE AND WE HAVE TO BE INAUDIB[INAUDIBLE] DEFINITELY. >> UNIVERSITY OF PENNSYLVANIA. I HOPE WE WILL NEVER REQUIRE THEM OF IT CLINICAL TRIAL TO ONLY BE DONE IN THE UT. I THINK WE NEED TO THINK ABOUT THE WORLD. BUT RELATED TO THAT YOU MENTION MENTIONED THE TUSKEGEE TRIALS AND THERE ARE SOME ETHICAL ISSUES TO BE CONCERNED -- CONSIDERED. AND I DIDN'T HEAR ANYTHING HERE ABOUT ALSO PARTNERING IN TERMS OF LOOKING AT SOME OF THE ETH ETHICAL ISSUES OF GROWING FROM ETHNIC MINORITIES. MANY OF THE MINORI THAT WE HAVE TRIED /TO STUDY IN THE PAST HAVE BEEN RELUCTANT TO BE PART OF TRIALS OR PART OF RESEARCH BECAUSE OF THE IMPLICATIONS AND BECAUSE OF /AA NUMBER OF ISSUES. SO IT'S REALLY IMPORTANT TO BE INCLUDING SOME OF THE ETHICAL DIYNAMICS AND ETHICAL ISSUES AND PRESIDENT OBAMA HAS A COMMISSION THAT HAS BEEN WORKING NOW FOR TWO, THREE YEARS ON SOME OF THE ETH/KHA*L ISSUES RELATED TO RESEARCH. SO I HOPE THAT THERE IS A PARTNERSHIP THERE. >> ABSOLUTELY. INAUDIB[INAUDIBLE] AMERICAN POPULATIONS AS AN EXAMPLE. SO HOW DO YOU REACH OUT IN /AA WAY THAT YOU HAVE INAUDIB[INAUDIBLE] THAT YOU CAN TRUST? AND IF YOU CAN GET THOSE INVESTIGATORS THAT HAVE CONNECTIONS WITH THE COMMUNITY TO ALSO BE THE INVESTIGATORS THAT ARE USED IN THE TRIALS. ONE OF THE CHALLENGES THAT WE FACE FOR THE INDUSTRY TO BROADEN THEIR /THRAEFP INTO SOME -- WHAT SOME MIGHT CONSIDER THE HARDER HARDER-TO-REACH COMMUNITIES TO ESTABLISH RELATIONSHIPS OF TRUST TRUST. INAUDIB[INAUDIBLE] DO YOU WANT TO TAKE A DRUG THAT HASN'T BEEN STUDIED ON PEOPLE LIKE YOU? YOU HAVE TO TALK THAT KIND OF QUESTION INAUDIB[INAUDIBLE] TRIALS DONE DONE. INAUDIB[INAUDIBLE] >> THANK YOU FOR YOUR PRESENTATION. I HAVEN'T SERVED ON THE PANELS NOW FOR AT LEAST THE /HRALAST 18 YEARS. I AM GLAD TO SEE US MAKING SOME PROGRESS. BUT I WONDERED WHAT YOU THINK OF THE NEXT APPROPRIATE STEPS SO THAT WE CAN GO BEYOND JUST AKING SOME REQUIREMENTS SUCH THAT IF THOSE MINUIMAL REQUIREMENTS OF THE DRUGS ARE NOT APPROVED? >> THAT IS A CONSIDERATION THAT I THINK WE HAVE TO THINK LONG AND HARD ON BECAUSE THERE IS INAUDIB[INAUDIBLE] INCLUSION AS WELL. OR WILL INCLUSION UGIS NOT INAUDIB[INAUDIBLE] STANDARD FOR SAFETY AND EV /KFFICACY INAUDIBL[INAUDIBLE] MARKE T. TO DATE AND WE HAVE LOOKED AT THIS DATA -- THERE HAS NOT BEEN A PRODUCT APPROVED BECAUSE OF DEMOGRAPHIC INCLUSION. HOWEVER, THERE WAS A STUDY PUBLISHED IN "JAMA" OF 2013, WHERE ONE /OF MY COLLEAGUES WHO LOOKED BACK AT NON-APPROVALS BY FDA AND I BELIEVE A 13-YEAR SPAN AND WHAT THEY DID FIND THAT THERE ARE EXAMPLES THAT DRUGS WERE NOT APPROVED BECAUSE THE APPROPRIATE POPULATION WAS NOT INCLUDED AND SO WE REALLY HAVE TO TAKE TO THIS CONVERATION WHERE PATIENTS INAUDIB[INAUDIBLE] KIND OF SEVERITY -- WERE THEY INCLUDED? INAUDIB[INAUDIBLE] WE READY -- REALLY NEED TO HAVE MORE PLAYINGS IN THESE TRIALS. I THINK IT REALLY COMES DOWN TO HOW WILLING THE POPULATIONS ARE INAUDIB[INAUDIBLE] OF THE PRODUCT AND SO PATIENTS ARE NOT -- BECAUSE THEY'RE NOT CLINICAL LY DEVELOPED PLAYINGS WHERE THEY SHOULD NOT BE APPROVED. I THINK FOR US IT TAKES -- LOOKING ONLY AT DEMOGRAPHIC IN INCLUSION WITHOUT TAKING INTO ACCOUNT THE CRITICAL ELEMENTS WOULD NOT BE THE BEST PATH TO TAKE ON BEHALF OF ALL AMERICANS. AND APPROVAL PROCESS BUT IN TERMS OF HOW -- I THINK WE NEED MORE WORK BECAUSE ONE OF THE CHALLENGES I FACE IN MY EV CAST Y ROLE IS THERE WAS A STATEMENT DR. COLLINS MADE EARLIER AS TO HOW MUCH ARE WILLING TO MISS IN TERMS OF NABLE INAUDIBLE OF HOW WE DESIGN TRIALS. AND IF WE'RE MISSING SOMETHING IN CERTAIN DEMOGRAPHICS THAT MINUIMUM AMOUNT WE'RE GOING TO TOLERATE? A TRIAL. >> AND I CAN AGREE WITH YOU PARTICULARLY AS IT COMES TO -- WE LOOK AT DISEASE-SPECIFIC DRUGS FOR TREATMENT OF DISEASES. BUT WHEN WE'RE TALKING ABOUT INTERVENTION AND WELLNESS A A/RAOEARENA, BEFORE SYMPTOMS ARE RISK FACTORS ARE VERY IMPORTANT THAT WE HAVE SOME REALLY STRICT CRY /TAOITERIA THAT WE HAVE TO BE VERY IN/KHRAOCLUSIVE OF ALL THE DEMOGRAPHICS IN ORDER TO UNDERSTAND WHETHER OR NOT IT REALLY DOES NEED TO TARGET A PREVENTION THAT WE ARE SEEKING. >> THANK YOU, DR. MONTGOMERY RICE. IS IT SHORT? >> YOU MENTIONED PHASE FOUR SO THE POST MARKETING APPROVAL PROCESS -- MORE OF THIS INFORMATION. ARE THERE ANY INITIATIVES UNDER WAY TO /TRAOTRY TO PROVIDE A MORE RIG RIGOR --. . ALREADY THANK YOU FOR THAT MENTION. /PHRA[APPLAUSE] PRESENTATION. >> OKAY, WE HAVE A BREAK UNTIL 11:30. SO I'LL SEE YOU BACK HERE AT 11: 11:307. THANK YOU. WE'RE BREAKING FOR 15 MINUTES. >> CALLER: GREAT. THANKS VERY MUCH. >> SHE HAS SPENT TREMENDOUS WORK IN THE ENGINEERING OF INCLUSION POLICY AND IS INDEED THE WORLD EXPERT ON THIS TOPIC. I'D LIKE TO POINT OUT THAT TODAY TODAY'S UPDATE IS A SHORT REPORT THAT WILL BE COMING UP IN THE SPRING, SO PLEASE STAY TUNED. IT IS MY GREAT PLEASURE TO INTRODUCE DR. MEREDITH TEMPLE O' O'CONNORS. /PHRA [APPLAUSE] >> THANK YOU. WOW. THAT'S QUITE THE INTRODUCTION. I REALLY APPRECIATE THAT, TERRY. PUT SOME PRESSURE ON ME. OKAY, SHOI SHOULD BE FAMILIAR TO A LOT /OF YOU BECAUSE I DID TALK TO YOU ALL ABOUT INCLUSION AND INCLUSION DATA. WE'RE NOT TALKING ABOUT THE IN INCLUSION DATA TODAY BECAUSE NOTHING IS GOING TO CHANGE SINCE THE /HRALAST TIME IN TERMS OF THE DATA. SO TODAY'S FOCUS, WHAT'S ILLEGAL TO UPDATE YOU ON OUR REENGINEER REENGINEERING EFFORTS. SPONTANEITY LOT /OF EFFORT IN THE BAST THREE YEARS AND DONE IN CON CONJUNCTION WITH OR /W-FPWH AND JANINE IN PARTICULAR. SO THE GOALS OF TODAY'S PRESENTATION -- JANINE AND I BOTH THOUGHT IT WOULD BE GOOD TO GIVE YOU A BRIEF OVERVIEW OF THE POLICY JUST TO MAKE /SHAOSURE THAT EVERYBODY'S ON THE SAME PAGE -- DEFINING OUR UNIVERSE, WHAT IT MEANS THOINCLUDE, WHERE WE'RE HEADED. A LOT OF THE SAME THEMES YOU HEARD IN JANINE'S TALK AS WELL AS JONCA'S UN-- TALK. ONE OF THE THINGS BETWEEN HER TALK AND MY TALK IS THAT WE HAVE REACHED OUT TO EACH OTHER TO DEVELOP AN NIH-FDA WORKINGUP INTO HON HIN CONCLUSION ISSUES SO THAT WE CAN SHARE INFORMATION ABOUT THE PRACTICES AND TALK ABOUT POINTS AND CHALLENGES TOGETHER AS /AA GROUP. SO THIS WOULD BE A WORKING GROUP OF OUR GOVERNANCE BODY THAT JAN JANINE CO-CHAIR, ALONG WITH AP-- AL /SKPA*P STAFF WE HAVE AN OPTION -- WE WILL NOW BE TAKING NEXT /STWEPZ TO GET BA-- THAT GROUP GOING AND STARTING TO TALK ABOUT AND DELVE INTO THESE DIFFICULT AND CHALLENGING PIECES THAT JONCA WAS TALKING ABOUT. SO AFTER I TALK ABOUT THE UNIVERSE, TALK ABOUT THE RE REENGINEER HIGHWAY SPECIFICALLY. AT NIH SOME OF THE KEY CHANGES. THE NEW DATA SYSTEM. WHAT WE'RE LEARNING ALONG THIS PATH, AND TOUCH ON IT AT THE CLOSE ABOUT THE IM/PABPACT OF THE CHANGE IN THE REPORTING, KIND OF WHAT YOU ALL ABOUT -- WILL START TO SEE OVER /THE COMING YEARS. SO THE BRIEF OVERSLEW OF HIN CONCLUSION POLICY. I FEEL LIKE I'M PREACHING TO THE POLICY HERE IN TERMS OF DEFINING THE /KWHRAOUFRS. SO AS ALL OF YOU ARE INTIMATE LY FAMILIAR WITH, THE INCLUSION ON WOMEN AND MINORITIES IS MANDATED BY LAW FOR ALL NIH-FUNDED OR SUPPORTED CLINICAL RESEARCH. THERE IS SOME CONFUSION OUT IN OUR COMMUNITY AS WELL AS TIMMER TIMMERLY AT NIH AS TO WHAT'S EN EN/KOCOM PALACEED UNDER INCLUSION POLICY. IT DOES INCLUDE IN/TTRAMURAL AND EXTRAMURAL AND WHETHER IT'S A GRANT, A COOP /ERATIVE AGREEMENT O OAIR GRANT AND THE NIH DEFINITION AND THAT DEFINITION /-FGS JUST A TAKE- TAKE-HOME MESSAGE FROM ALL OF THAT IS THIS IS VERY BROAD DEFINITION. WHAT THAT MEANS FROM AN IMPLEMENTATION PERCESPECTIVE IS THAT THERE IS VERY DILL -- LITTLE THAT'S CONSIDERED HUMAN SUBJECTS RESEARCH THAT'S ALSO GOING TO MEET THE NIH DEFINITION FOR CLINICAL RESEARCH. SO THAT'S THE MESSAGING WE'RE TRYING TO GET OUT TO FOLKS IS UNSTANDING INCLUSION POLICY. AND THERE IS ALSO ADDITIONAL REQUIREMENTS FOR NIH-DEFINED PHASE THREE CLIJ TRIALS THAT RELATE TO UNBIAS DESIGN THE ASSESSMENT OF POTENTIAL DIFFERENCES. WHAT THAT DOESN'T REALLY TELL US IS WHAT IT MEANS TO INCLUDE. THIS STATEMENT YOU ALL HAVE SEEN BEFORE. JANINE AND ALAN AND I PRESENTED THIS A COUPLE YEARS AGO, I BELIEVE NOW. WHICH WAS REALLY A PUBLIC STATEMENT THE GOVERNANCE GROUP CAME UP WITH WHEN THEY WERE STARTING TO SIT DOWN AND SIFT THROUGH SOME OF THE ISSUES AT HAND. THE /PWOPBOTTOM LINE /-OF THIS PURPOSE STATEMENT IS "DOES THE STUDY HELP THE RIGHT PEOPLE FOR THE SCIENCE"? YOU'VE HEARD FROM JONCA AND FROM ME AS WELL IS DO WE HAVE THE RIGHT PEOPLE FOR THE SCIENCE? AND THAT'S THE MESSAGE WEARING TRYING TO GET OUT WITH OUR RE REENGINEERING. SO SOME OF THE KEY EVENTS ON THE TIMELINE.^ A LOT OF THESE ARE GOING TO BE VERY FAMILIAR THINGS FOR YOU ALL. MORE RECENTLY, WE DID, AS /I TALKED ABOUT, REORGANIZED THE GOVERNANCE STRUCTURE IN 2011, TO INTEGRATE IT INTO THE NIH'S GOVERNANCE STRUCTURE. WE CONDUCTED A BUSINESS PROCESS MODELING WITH FUNDS FOR THE RESEARCH AND FROM THAT BUSINESS PROCESS MODELING THE REORGANIZED GOVERNANCE STRUCTURE AS WELL AS THE INCLUSION TASK FORCE THAT ASSESSED THE CURRENT STATUS OF INCLUSION. WE'VE DECIDED TO /REENGINEER OUR BUSINESS PROCESSES AND CREATE A NEW DATA SYSTEM RATHER THAN TRY TO UPDATE OUR DATA SYSTEM. SO A LOT /OF THESE EFFORTS ARE STILL GOING AND THAT'S WHAT I WANT ED TO TALK TO YOU ABOUT TODAY. SO THE BOTTOM LINE IN TERMS OF KIND OF DEFINING OUR UNIVERSE, WHAT IS HAPPENING, THE RE REENGINEERING IS THAT IT'S REALLY A PERCESPECTIVE SHIFT. THE POLICIES ARE THE SAME. IT'S REALLY A SHIFT IN,000 -- HOW WE LOOK AT INCLUSION AT NIH AND I THINK EVEN MORE BROADLY THAN JUST NIH. FOR SOME PEOPLE THIS REALLY ISN'T A SHIFT AT ALL. BEING KIND OF DO YOU HAVE THE RIGHT PEOPLE FOR YOUR SCIENCE IS WHERE A LOT /OF FOLKS HAVE BEEN. SO MORE IN THE LENS OF BEING AN ACCOUNTING PROCESS. AND ARE WE COUNTING THE RIGHT PEOPLE RATHER THAN THINKING ABOUT OKAY, GREAT, WE'VE COUNTED PEOPLE BUT DO WE HAVE THE RIGHT PEOPLE FOR THAT SCIENTIFIC QUESTION? AND SO THAT'S WHERE THE SHIFT CAN COME FOR SOME FOLKS WHO ARE THINKING MORE FROM THAT LENS. YES, WE ARE STILL COUNTING PEOPLE. THAT GIVES US INFORMATION ABOUT HOW WE KNOW THAT WE HAVE THE RIGHT PEOPLE. BUT I THINK IT'S JUST /AA DIFFERENT LENS, PERCESPECTIVE WITH HOW WE WANT /TO CONSIDER INCLUSION. SO WITH THAT AS KIND OF /AA FRAMEWORK, HERE IS SOME OF THE KEY CHANGES UNDER WAY WITH THE RE/TPWH-RPLGING. WE'VE MODIFIED THE FORMS LAYOUT FROM INVESTIGATORS THAT ARE REPORTING INCLUSION DATA THOUGHT NIH. WE'VE /STHRAEPLLINED SOME OF OUR INTERNAL PROCESSES AND /PHROERZ. /SWHRAOEFPBL UPDATED OUR REVIEW ER TEMPLATES AND GUIDELINES. WE DO HAVE UPDATEED TRAINING AND FAQ'S ON HOW ALL THIS IS GOING TO WORK /SAND WE HAVE THE NEW IN INCLUSION MANAGEMENT SYSTEM, WHICH IS THE NEW ERA DATA SYSTEM THAT WILL BE INTEGRATED WITH OTHER DATA SYSTEMS AT NIH. SO THIS IS WHAT THE CHANGE ON THE FORMS LOOK LIKE. ON THE LEFT IS /THE PLANNED EN ENROLLMENT STORM AND THE RIGHT IS /THE CUM /HRULATIVE. ON THE IS RIGHT WHAT THEY ARE ACTUALLY DOING, IF THEIR AWARD IS IN PROGRESS. THE COLLECTION IS /THE SAME. THE RACIAL AND ETHNIC STANDARDS ARE THE SAME. A COUPLE /OF KEY CHANGES ON THE ENROLLMENT REPORT. THE FIRST IS WE ADDED THE MORE THAN ONE RACE CATEGORY. THIS IS AN AGGREGATE CATEGORY SO INVESTIGATORS SHOULD HOLD UP ON THIS. PARTICIPANTS IDENTIFY WITH MORE THAN ONE RACIAL CATEGORY. IT WAS NOT PREVIOUSLY ON THE PLAN. IT WAS ONLY ON THE ACTUAL, WHICH CAUSED SOME HEARTBURN IN TERS OF INVESTIGATORS WHO KNEW THEY WOULD BE WORKING WITH THESE POPULATIONS, HOW THEY WOULD ACCOUNT FOR THEM ON THEIR FORM. SO WE'VE ADDED THAT TO /TRAOTRY TO LINE UP OUR FORMS AND SIMPLIFY THE LAYOUT AND REALLY DRIVE HOME THE /STK*EUBGS BETWEEN RACE AND ETH/TPHENICITY IN TERMS OF REPORTING. SO WE'RE REALLY TRYING TO TAI -- SAY TO PEOPLE YOU NEED TO THINK ABOUT RACE AND ETH/TPHENICITY IN ADDITION TO SEX GENDER. ANOTHER PIECE IS WE ALWAYS ASK INVESTIGATORS TO TELL US WHETHER THEIR STUDY WAS WITH U.S. PARTICIPANTS OR NON-U.S. PARTICIPANTS. NFORMATION COMING IN WITH THE SO THAT WE CAN HAVE THAT AP, A RATHER THAN STAFF HAVING TO DIG THROUGH THE APPLICATION AND FIGURE OUT WHAT'S /WWHAT. IN TERMS OF PEER REVIEW-SPECIFIC CHANGES, WE'VE UPDATED THE CRIT CRITIQUE TEMPLATES, WHICH I'LL SHOW YOU ON THE NEXT SLIDE. AND WE'VE ISSUED SOME GUIDANCE TO OFFICERS AND HOW /TO IMPLEMENT THIS. WE'VE ALSO UPDATED OUR REVIEW ER GUIDELINES AND ALL OF THIS AGAIN WAS WITH THIS GOAL OF GETTING OUR PEER REVIEWS FOCUSED ON DO YOU HAVE THE RIGHT PEOPLE FOR THE SCIENCE? ARE THEY TACKLING THIS ISSUE? ARE THEY TALKING ABOUT IT AND HAVE THEY ADDRESSED IT /PWROEPT /PWROEPTLY? SO THIS IS WHAT THE TEMPLATE PREVIOUSLY LOOKED LIKE. ANY OF YOU ALL WHO HAVE BEEN SERVING ON PANELS WOULD PROBABLY BE FAMILIAR WITH THE DROP-DOWN OF ALL THE DIFFERENT CODE COMBINATIONS AND IT REALLY GOT THE REVIEWERS FOCUSED ON THE CODE RATHER THAN THE SCIENCE, WHICH IS REALLY WHERE WE WANT OUR PEER REVIEWERS TO BE. SO WE CHANGED IT FROM THIS BIG COMPLICATED KIND OF DROP-DOWN OF CODES WHICH WE USED FOR INTERNAL PROCESSING AT NIH AND WHERE WE GET THE REVIEWERS SAYING IS A DISTRIBUTION JUSTIFIED SCIENTIFICALLY? AND THEY HAVE TWO CHOICES FOR SEX GENDER. /SKWHROEUFD OR THIS IS THE-. AND IF IT IS NOT, JUST LIKE NOW, IF IT IS, THEN THEY CAN MAY THAT -- SAY THAT IT'S ACCEPTABLE AND WE HAVE THE SAME FOR RACE, ETH/TPHENICITY AND THE INCLUSION AND EXCLUSION OF CHILDREN UNDER 21 AN THEN COMMENTS REQUIRED IF IT'S NOT APPLICABLE. AND IF IT'S NOT CONSIDERED HUMAN SUBJECTS RESEARCH. AND NOT E 4, IRB EXEMPTION NO. 4 4, WHICH IS WHAT IS. SO THOSE ARE SOME CHANGES REALLY TRYING TO DRIVE HOME TO OUR PEER REVIEWERS ABOUT SOME CONFUSION IN THE PEER REVIEW COMMUNITY ABOUT EXPECTATIONS THAT WE WANT WANTED THEM FOCUSED ON THAT SCIENCE. SO THE SYSTEM ITSELF AND WE'LL RE/PHRAEPLACE OUR CURRENT DATA SYSTEM. IT WILL STREAMLINE DATA ENTRY, ENGAGING INVESTIGATE ORGANIZERS MORE DIRECTLY. THEY WILL HAVE ACCESS THROUGH THE COMMONS SO THEY CAN SEE AND WE CAN SEE WHAT THEY'VE SUBMIT SUBMITTED EVERYBODY'S ON THE SAME PAGE. WE'D LIKE ONE /OF OUR MAJOR GOALS IS ENHANCING THE DATA ACCURACY, THE /SKPOERP THE ACCOUNTABILITY. TRYING TO MAKE THINGS MORE TRANS TRANSPARENT IN TERMS OF WHAT THEY PROVIDE US, WHAT WE APROVE AND WHAT WE ARE ALL SEEING THE SAME THING ON THE SAME PAGE OVER THE LIFETIME OF THE AWARDS. INTEGRATE THINGS WITH OUR EXIST HIGHWAY AWARD WORK FLOWS AND PROVIDE SOME TOOLS FOR STAFF AND MONITORING PROGRESS. SO WHAT ARE WE LEARNING? REENGINEERING EFFORTS SOME KEY ELEMENTS THAT WE'VE IDENTIFIED HAT IS SUBJECT TO THE POLICY?. WHAT ARE EXPECTATIONS KIND OF BACK TO /TTHAT DEFINING THE UNIVERSE? ALSO, SOMETHING THAT'S REALLY IMPORTANT FOR NIH STAFF IN TERMS OF UNDERSTANDGED OUR PORT /TPOFOLIO AT DIFFERENT LEVELS. SO I THINK ALAN AND JANINE RAISE RAISED THIS POINT HERE IN TERMS OF YOU CAN BE DOING IT ALL RIGHT FOR EVERY INDIVIDUAL STUDY, THE PEER REVIEWERS ARE DOING THEIR JOB AND WE'RE DOING OUR JOB BUT THAT DOESN'T GIVE US DIFFERENT VIEWS ABOUT PORT /TPOFOLIO IN TERMS OF WHETHER WHAT GAPS WE MAY HAVE IN OUR PORT /TPOFOLIO IN TERMS OF IN INCLUSION IN PARTICULAR DISEASE AND CONDITION AREAS FOR RESEARCH RESEARCH. SO WE'RE HOPING THAT ANOTHER PIECE OF THIS NEW SYSTEM WILL BE GIVING NIH STAFF THE TOOLS TO LOOK AT /THIS PORT /TPOEFOLIO IN DIFFERENT WAYS. IT'S ALSO WORKING TO CHANGE THE PERCESPECTIVE AND ENHANCE THE VALUE OF THIS INFORMATION. SO THE BLIND MAN AND THE HE WILL ELEPHANT. EVERYBODY'S WORKING AT DIFFERENT PIECES AND PULL EVERYBODY BACK AND WHOLE -- LOOK AT THE WHOLE HE WIELEPHANT. SO THE IM/PABPACT OF REENGINEERING AND NIM F ON THE INCLUSION REPORTING. SO THE SYSTEM IS DEPLOYING IN OCTOBER. WE'RE JUST /AA FEW WEEKS AWAY. THAT'S ALSO WHEN WE WILL UPDATE TO TRY TO STREAMLINE THIS PROCESS. WE'VE TIMED THIS CHANGE WITH THE CHANGEOVER IN FISCAL YEAR SO IN THE SHORT TERM I'LL BE COMING BACK TO YOU I BELIEVE IT'S APRIL COUNCIL MEETING TO TALK ABOUT THE BI/EENIAL DATA FOR 2013 AND 2014. SO THAT HAS CHANGED A WHOLE LOT FIRE COUPLE /OF REASONS. ONE, WE ARE CLOSING OTTHIS FISK FISCAL YEAR IN THE SAME SYSTEM THAT WE WERE IN BEFORE. SO THAT THE TWO YEARS CAN BE REPORTED AS /AA AIR AND LOOKED AT IN THE SAME WAY AND PULLED FROM THE SAME DATA TABLES IN OUR DATABASE. SO TO THE REPORT WOULD LOOK VERY MUCH LIKE IT DOES NOW. AS WE TRANSITION BETWEEN THE DATA SYSTEMS, IT MAINLY CHANGES TO THE FUTURE REPORTS. BUT I WOULD /HRAOEULIKE TO SAY THIS WILL TAKE TIME AS OUR GRANTS ARE ON AN AVERAGE 4-TO-FIVE-YEAR CYCLE GETTING PEOPLE USED TO THE SYSTEM, GETTING KIND OF GETTING THOSE WORKED THROUGH AS WE RELEASE THIS NEW SYSTEM AND THEN WE CAN START HAVING CONVERSATION CONVERSATIONS ABOUT HOW THE DATA COULD BE LOOKED AT /TIN DIFFERENT WAYS. SO JUST WANT /TED TO KIND OF TOUCH ON THOSE PIECES AS WELL IN TERMS OF WHAT IT'S GOING TO MEAN. I THINK ALSO THERE COULD BE SOME CHANGES IN THE WAY BOTTOM LINE OF THE NUMBERS BECAUSE WE'RE NOW REALLY TAKING /AA MORE SIMPLIFIED APPROACH. IF IT'S CLINICAL RESEARCH MONITORINGT. FENE IT'S COMING FROM THINGS LIKE EXISTING DATASETS THAT HAVE ALREADY BEEN MONITORED IN THE PAST, THEY'RE STILL RELEVANT TO MONITOR NOW WITH THIS NEW SCIENTIFIC QUESTION. THAT COULD CHANGE SOMEWHAT JUST WHAT OUR BOTTOM LINE NUMBERS LOOK LIKE BUT WE'LL KNOW MORE NEXT /SKPREUPBGT YEARS TO COME AS THE NEW SYSTEM DEPLOYS. JANINE, DID YOU HAVE ANYTHING TO ADD? >> I THINK YOU COVERED ALL OF THEM AND THE FULL AMOUNT OF THE TIME THAT WE HAVE ALLOTTED SO WE COULD HAVE ONE QUESTION. >> OKAY. DR. MYER? >> WELL, THIS IS A QUESTION OBVIOUSLY. I WAS WONDERING IF YOU CONSIDER ADDING RESEARCH INAUDIBL![INAUDIBLE]. THAT WOULD REALLY -- MANY OF US FOCUS A -- ALL OUR EFFORTS ON THE MAIN REVIEW CRY /TAOITERIA AND GO FORMAL. THE ONES AT THE BOTTOM BETWEEN THE MINORITIES. IF WE HAD THAT IN /AS AN EXAMPLE IS REALLY IM/PPERATIVE. >> IT ACTUALLY IS FOR CLINICAL. NOW THE /PPRECLINICAL STAGE I THINK HIM TO IS STILL -- EVERYTHING'S ON THE TABLE TO BE DISCUSSED. BUT IT IS ACTUALLY PART OF THE A APPROACH AND I THINK SO ONE OF THE THINGS WE'RE TRYING TO WORKING ON IS CHANGING THE TEMPLATE AND -- >> ANNOUNCER: INTERRUPTION. THE CONFERENCE CONTAINS LESS THAN THREE PARTICIPANTS AT /THIS TIME. IF YOU WOULD /HRAOEULIKE TO CONTINUE, PRESS STAR 1 NOW OR THE CONFERENCE WILL BE TERMINATED. >> BACK TO /TTHAT. I THINK IT IS IN THE APPROACH. BUT THE ISSUE IS PEOPLE DON'T REALIZE IT'S THERE AND SO IN ADDITION TO CHANGING THE TEM TEMPLATES AND CHANGING OUR REVIEW ER GUIDELINES, IT'S GOING TO BE /AA MESSAGING THING, AND THAT'S ONE /OF MY GOALS ONCE WE GET THE SYSTEM OUT AND ROLLING IS TO ALSO REACH BACK TO OUR WORK PEER REVIEW COMMUNITY, WHO ARE REALLY ARE A CONDUIT TO OUR REVIEWERS. TO SAY WHAT CAN WE DEVELOP TO GET THE COMMUNICATION OUT ABOUT WHAT OUR EXPECTATIONS ARE FOR IN INCONCLUSION AND WHERE IT ACTUALLY LIVES KIND OF IN THE CONTEXT OF PEER REVIEW. ALREADY FROM PREVIOUS EXPERIENCE EXPERIENCE, I HAVE NOT SEEN THAT AT ALL. >> RIGHT. >> AND I'M SORRY. YOU HAD A -- >> WHAT CYCLE IS -- IT ALREADY STARTED. N SO THERE WAS A BIT OF /AEU CHANGEOVER BETWEEN THE TWO WHERE WE ALOUD STUDY SECTION THAT'S WERE EARLY IN THE CYCLE. BUT IT SHOULD BE, I BELIEVE, IN ALL OF THEM AS OF NOW. >> PEER REVIEW TEMPLATES. >> RIGHT. >> TERESA, DID YOU WANT /TO MAKE A COMMENT? >> THANK YOU FOR THE REPORT, MEREDITH. MY QUESTION HAS TO DO WITH A POST MARKETING SURVEILLANCE ANALYSIS AND THE EXTRAMURAL COMMUNITY WE'VE BEEN LOOKING AT PUBLICATIONS, A LARGE NUMBER OF THEM THAT REALLY SHOW THE DISPRO DISPROPORTIONATE OF REPORTING ON MALES VERSUS FEMALES, WHICH WOULD SUGGEST THAT EITHER THERE IS -- AND THIS WOULD BE IN THE CLINICAL, NOT IN THE SCIENCE BASIS -- BASE -- THAT EITHER IN THE ROLE -- ROLLOUTS FOR THE CUM LA TIVE DATA THAT YOU ACQUIRED OVER /THE LIFE SPAN OF THE GRANTS THAT THERE IS PROPORTIONATE BUT THEN IT DOESN'T GET RECORDED FOR SOME UNKNOWN REASON. OR THAT PEER REVIEW IS CHECKING SUCH GENDER OKAY, WITH WHATEVER JUSTIFICATION IS IN /AA GRANT AND THAT IS DISPROPORTIONATE ITSELF. SO WITH THE NEW SYSTEM, IS THERE A WAY FOR YOU TO DO THE KIND OF AUDIT POST-GRANT TO DETERMINE WHAT IS HAPPENING THERE? AND THE SURVEYS THAT WE'RE DOING ARE OF NIH-SUPPORTED GRANTS BY AND LARGE, NOT FAPHARMA. WHICH WOULD BE A DIFFERENT QUESTION. SO CAN YOU ADDRESS THAT KIND OF ADVERSE EVENT EXPERIENCE IN A POST-GRANT PERIOD AND HOW NIH MIGHT BE ABLE TO -- >> RIGHT. SHOFROM THE TECHNICAL PIECE, I THINK A COUPLE THINGS I CAN.^ A WE ARE GOING TO HAVE AN ELECTRONIC FINAL CLOSEOUT FOR OUR PROGRESS REPORT THAT WILL HELP US FROM A TECHNICAL PERCENT PERSPECTIVE GET THAT INFORMATION OF WHAT THE FINAL NUMBERS ACTUALLY REALLY LOOK LIKE IN TERMS OF THE GRANT WE HAVEN'T -- WE'VE HAD THAT IN TERMS OF ASKING THEM FOR IT BUT WE HAVEN'T HAD IT AS STRUCTURED DATA IN THE PAST BECAUSE A LOT OF TIMES THINGS WOULD STOP WITH THE LAST PROGRESS REPORT. OF COURSE, THEN THEY HAVE ANHER YEAR TO GO AND THEN THEY CAN PROVIDE IT BUT IT WASN'T REALLY STRUCTURED IN OUR SYSTEM. SO ONE /OF OUR GOALS AS WE GET A FINAL RPR IS IN PLACE IS TO HAVE THAT STRUCTURED INFORMATION TO START LOOKING AT. 'S.FRAY TECHNICAL PERCESPECTIVE BUT I THINK THE ISSUE IS WHAT HAPPENS AFTER THAT. THE CLOSEOUT IS DONE AND I KNOW THIS IS AN ISSUE AND I DON'T KNOW IF JANINE HAS SOMETHING TO SAY ABOUT IT. BUT I KNOW IT'S AN ISSUE. I'M NOT SURE WHAT THE SYSTEM OR GRANTS AWARDING PROCESS CAN DO DIRECTLY. I DON'T THINK THAT LET /US COMPLETELY OFF /THE HOOK BUT I THINK IT'S A COMPLICATED ISSUE. I DON'T KNOW IF YOU HAVE THOUGHT ABOUT THAT, IIANIN. 0 FORTUNATELY, EVEN FOR PHASE THREE CLINICAL /TRAOEUTRIALS, FEWER THAN A THIRD OF THOSE HAD SEX RESULT IN THE PUBLICATION. SO THIS IS AN ISSUE THAT WE NEED TO WORK NONCOLLABORATION AND PARTNERSHIP WITH THE SCIENTIFIC ASSOCIATION, SOCIETIES AND PUBLISHERS AND JOURNAL HE HEDITORS. AS YOU KNOW, WE'VE SPONSORED SEVERAL MEETINGS WITH JOURNAL HE HAD TORS, AND THIS IS A CHALLENGING COLLABORATION AND /KWOL LISTING. SO MANY OF YOU ARE ON HE HEDITORIAL BOARD AND YOU CAN HELP US WITH IT SO I THINK YOUR FIRST PART OF YOUR WE, MEREDITH YOU DID ANSWER IN THAT THERE WILL BE A WAY TO CAPTURE THAT DATA GOING FORWARD. RE DECISIONS BASED ON ON WHAT WE DO AND HOW WE MAKE SOMEBODY'S TRACK RECORD. CERTAINLY WOULD LOVE TO HEAR FROM THE MEMBERS IN THE DISCUSSION SECTION ABOUT WHAT YOUR THOUGHTS ARE. BUT IN THE INTEREST OF TIME, I'M GOING TO HAVE TO ASK THAT WE MOVE ON. THANK YOU VERY MUCH, DR. O'CON O'CONNOR. APPRECIATE THAT. AND DR. MAYRY HE WILELLIS SHIRLEY WILL INTRODUCE OUR NEXT SPEAKER. >> GOOD MORNING. I'M THE ASSOCIATE DIRECTOR FOR PROFESSIONAL PROJECTS AND CENTER CENTER. AND IT IS WITH GREAT PLEASURE THAT I'D LIKE TO ANSWER -- INTRODUCE DR. SHERRY MC MC/SKWRAOEUFPLT KNEW HER -- SHER SHERRY IN TORONTO. SHOI THINK THAT YOU'RE IN FOR A WONDERFUL TREAT FROM A SUPERB RESEARCH ER. DR. MCKIE IS A PROFESSOR OF PSYCHIATRY AT THE YALE SCHOOL OF MEDICINE. SHE IS DIRECTOR OF THE YALE BEHAVIORAL FAPHARMACOLOGY LABORATORY AND CLINICAL DIRECTOR OF THE YALE TOBACCO TREATMENT CLINICAL IN THE FORD ADDICTION CLINICAL. HER RESEARCH IS FOCUSED ON IM IMPROVING OUTCOMES FOR THOSE WITH A ADDICTIVE DISORDERS. DR. MCKIE'S WORK IN SURVEY RESEARCH AND EPIDEMIOLOGICAL RESEARCH TO UNCOVER THE MECH MECHANISMS UNDERLYING POOR OUT OUTCOMES AND TO TRANSLATE THESE FINDINGS INTO IMPROVED INTER INTERVENTION. A VERY IMPORTANT FOCUS OF HER WORK IS TO DEVELOP GENDER-SENSE GENDER-SENSITIVE TREATMENT FOR ADDICTION AND SHE IS THE PRINCIPAL INVESTIGATOR OF THE YALE SCORE, WHICH IS AIMED AT DEVELOPING THERAPEUTICS FOR TOBACCO, DEPENDENTS. SHE HAS BEEN WIDELY RECOGNIZED BY MANY SCIENTIFIC COMMUNITIES, INCLUDING THE RESEARCH OF SEW SOCIETY FOR ALCOHOLISM, THE RESEARCH COUNCIL OF CANADA, AND MOST RECENTLY IT HAS BEEN ELECT ELECTED PRESIDENT OF THE SOCIETY OF THE ADDICTION PSYCHOLOGIST FOR THE AMERICAN PSYCHOLOGICAL ASSOCIATION. SO THANK YOU, SHERRY, FOR YOUR TALK. >> THANK YOU FOR THAT INTRODUCTION. AND I VERY MUCH APPRECIATE THE OPPORTUNITY TO TALK WITH YOU TODAY. SO JUST TO START -- >> I WANT TO MAKE /SHAOSURE EVERYBODY CAN HEAR YOU. DO YOU HAVE THAT OTHER MIC? >> THANK YOU. ALL RIGHT, IS THAT BETTER? >> OKAY, THANK YOU. >> SO JUST /AA COUPLE /-OF COMMENTS ABOUT THE TITLE. I HAVE IN TNOTICEDED THIS IS IN REFERENCE TO THE JOHN STEINBEK NOVEL OF "MICE AND MEN" AND THIS TITLE IS IN THE JOURNAL ARTICLES TO INDICATE RESEARCH THAT SPANS ANIMALS TO HUMANS. LANGUAGE MATTERS, AND THE USE OF THIS REFERENCE IN /THIS CONTEXT IS A BIT -- BECAUSE IT'S NOT IN IN/KHRAOCLUSIVE. SO I'M CURIOUS AND 99 JOURNALS THAT REFERENCE "MICE TO MEN."^ AND INAUDIB[INAUDIBLE] AND IN MAJOR JOURNALS. SO I PARTICULARLY LIKED THIS LAST ONE, MICE AND MEN WORKING TOGETHER THROUGH 100 YEARS IN THE FIGHT AGAINST CANCER. SO IN THE TALK WE GO BEYOND MICE AND MEN AND TALK ABOUT THE TWO YEARS WE'VE BEEN FUNDED FOR. THIS WORK SPANS T 1 TO T 4 TRANS TRANSLATIONS AND OUR MAIN AIM IS TO FOCUSED ON THE DEVELOPMENT OF GENDER-SENSITIVE THERAPEUTICS WITH SMOKING SCESSATION. WE HAVE TRAINED INVESTIGATEORS AND -- ON WOMEN AND TOBACCO. SO TOBACCO SEEMS TO BE THE LEADING CAUSE OF PREVENTABLE MOR MORTALITY IN THE UNITED STATES. AND IT'S THE REASON WHY WE FOCUS ON TOBACCO USE. THIS GRAPH HERE IS SOME RECENT DATA FROM THE SURGEON GENERAL'S REPORT AND THERE HAS BEEN SIGNIFICANT PROGRESS MADE IN REDUCING RATES FOR TOBACCO USE IN THE U.S. HENCE, THE FIRST SURGEON GENERAL'S REPORT WHICH WAS PUBLISHED A FEW YEARS AGO. BUT IF YOU LOOK AT THE CURRENT RATES TODAY, MORE THAN ONE IN FIVE ADULTS ARE STILL CURRENT SMOKERS AND IT PUTS THE DEATH RATE IN CONTEXT. THAT'S THE ENTIRE POPULATION OF ATLANTA DYING EACH YEAR FROM SOMETHING THAT'S COMPLETELY PREVENTABLE. AND IF YOU COMPARED THAT TO HISTORIC RATES SUCH AS ALL THE CITIZENS AND CURRENT ANNUAL DEATH RATINGS FOR ACONDITIONS, THERE IS MONTH COMPARISON. SO WE STILL HAVE A LOT /OF WORK TO DO WITH TOBACCO USE. UNT FOR TOBACCO /SPHOERGZ, WE KNOW THAT EVEN WHEN YOU WOMEN ARE MORE LIKELY TO DEVELOP TOBACCO-RELATED DISEASE SUCH A LUNG CANCER AND HEART DISEASE. WOMEN ALSO EXPERIENCE A NUMBER OF SEX-SPECIFIC HEALTH RISKS PRIMARILY ASSOCIATED WITH THEIR REPRODUCTIVE HEALTH. WE ALSO KNOW THAT WOMEN HAVE MORE DIFFICULTY QUITTING. SO IN /THIS GRAPH WE SHOW CDC DATA SHOWING EVERY YEAR IN THE 45 YEARS OF THIS DATA THAT QUIT RATES FOR MEN ARE HIGHER THAN WORE -- FOR WOMEN. NOW HOWEVER, THIS DATA WAS JUST PUT OUT BY THE SURGEON GENERAL'S REPORT WITH THE CONCLUSION THAT BY 2005 THE DIFFERENCE BETWEEN GENDER WAS TRIVIAL. NOW, GLAD TO HAVE THE SURGEON GENERAL'S REPORT. SO I HAD A LOOK AT THE AUTHOR AUTHORSHIP OF WHO WAS INVOLVED IN THE SURGEON GENERAL'S REPORT, AND I WAS GOING TO /PHAUMAKE A SLIDE BUT I DECIDED NOT TO OUT THEM. BUT SCIENTISTS AND WHILE THERE WERE RESEARCHERS WHO FOCUSED ON REPRODUCTIVE HEALTH, THERE WASN'T ONE THAT FOCUSED ON SEX DIFFERENCES SO THIS IS JUST DATA THAT WE'VE PUBLISHED RECENTLY SHOWING THAT WOMEN HAVE GREATER RE/HRALAPSE RATES IN /AA LARGE EPIDEMIOLOGICAL SAMPLE. WOMEN HAVE GREATER QUITTING. WOMEN HAVE LESS LIKELY TO CHIEF AB/STEUSTIN ENCE. AND INTERESTINGLY ALL THESE ODD RATIOS ARE FAIRLY SIMILAR AND ARE SUPPORTED BY MANY OTHER RESULTS GENERATED BY OTHER RESEARCHERS. SO ANOTHER LOOK THAT THE DATA THE SURGEON GENERAL'S REPORTING ON AND WHAT THEY REPORTED ON S WITH A SIMPLE RATIO OF FORMER SMOKERS. SO IN COLLABORATION WITH /STPOEBGZ OF THE BIRCH SCHOLAR AND /AA GENIUS THAT I THINK MENT MENTORED, WE LOOKED AT WHAT IS INFLUENCEING THIS RATIO AND BIAS BIASING THIS RATIO. AND, WITH FACTORS OTHER THAN BEHAVIORS. SO AUCTION -- AS YOU CAN SEE, THIS RATIO IS INFLUENCED BY ADULT BECOME -- COMING IN /SKP OUT OF POPULATION, WHETHER THAT'S DUE TO IMMIGRATION, EM EMIGRATION, DEATH, WHICH IS INFLUENTIALED BY THE AGE OF THE POPULATION, AND NEW SMOKERS AND ALSO RE/HRALAPSEERS. SO /-MANY OTHER INFLUENCES BESIDES ACTUAL QUITTING. AND OTHER THING ABOUT THIS RATIO IS TIME, WHICH CAN BE 80 OR 90 PLUS YEARS. SO IT'S A VERY POOR MERTRIC TO TRACK YEAR LY CHANGES AND TRENDS. AND THIS COULD LEAD TO MIS MISINTERPRETATION OF POPULATION TRENDSPED IN THOSE DIFFERENCES. SO PHIL AND I HAVE COME UP WITH AN IMPROVED MERIT YUK, WHICH WE'RE CALLING THE QUIT INDEX THIS WAS ASSESSED OVER /THE PAST 12 MONTHS AND IT'S SIMPLY A RATIO OF QUITTING OVER LE LAPSE LAPSING. AND WHEN WE LOOK AT /THIS MEASURE, WE CAN SEE THAT THERE IS VERY CLEAR GENDER DIFFERENCE S IN THE QUIT INDEX AND THAT SUPPORTS OTHER FINDINGS IN THE LITERATURE AND WE ALSO CALCULATED THE QUIT RATIO AND WE SEE THAT THE FINDINGS IN /THIS DATASET MIRROR WHAT WE SEE IN THE SURGEON GENERAL'S. SO ONE CONCLUSION IS THAT IT'S -- SUCH AS THE SURGEON GENERAL'S REPORT WHO WILL BE MINDFUL OF THE LITERATURE AND CAN ENSURE THAT ACCURATE CONCLUSIONS ARE SUPPORTED AND REPORTED IN POLICY DOCUMENTS. ME TRENDS TO NYCTOINE IN ANOTHER ANALYSIS WE TRACKED DEPENDENCE SHOWING THAT YOU HAVE A SIGNIFICANT DATA SLOPE IN MEN IN STRATIFIED ANALYSIS AND NOT SO IN WOMEN AND THIS LACK OF /AA DECLINE INDEPENDENCE, WHICH REALLY IS DRIVEN BY DEPENDENCE IT CLITHIER IA AND NEGATIVE EFFECT. SO THERE IS A NUMBER OF FACTORS THAT HAVE BEEN IDENTIFIED AS TO WHY WOMEN HAVE MORE DIFFICULTY QUITTING. AND WE HAVE CONDUCTED RESEARCH ON ALL OF THESE FACTORS AND I'LL BE REPORTING ON SOME OF THAT. BUT IN PARTICULAR WE FOCUSED ON DEALING WITH STRESS AND NEGATIVE EFFECT. SO WITH REGARD TO MEDICATION RESPONSE, NYCICOTINE REPLACEMENT IS /THE MOST COMMONLY USED. NYCICOTINE SMOKING SECESSATION TREATMENT /STKWRARPBLGS WHICH MAY BE LESS EFFECT /KWREUIVE FOR WOMEN. THERE IS LABORATORY-BASED DATA HERE BY ROBERT WEST SHOWING SEX DIFFERENCE S S IN MEDICATION EV CAST Y AND CONDUCT AID SYSTEM /AATIC REVIEW OF THE LITERATURE, IDENTIFIED 42 CLINICAL TRIAL STUDIES, GENDER REPRESENTATION IN THE SAMPLE. BUT ONLY 21 OF THE STUDIES ANALYZED OUTINCOMES BY GENDER AND OF THOSE 14 FOUND NO DIFFERENCE S S IN OUTCOME. THE OTHERS DID FIND DIFFERENCES WITH BETTER OUTCOMES FOR MEN VERSUS WOMEN. ONLY 5 OF THE STUDIES PROVIDED DATA BY GENDER AND ONLY ONE STUDY EXAMINED SIDE EFFECT BY GENDER. KEL GI, WHO LEAD OUR IMAGING PROJECT IN THE CENTER, HAS PRODUCED THE FIRST NEWUROCHEMICAL DATA TO SUGGEST WOMEN HAVE POOR RESPONSE NYCICOTINE REPLACEMENT THERAPY AND DEMONSTRATED THAT AN /EUPB INCREASED UPREGULATION OF RECEPT RECEPTORS IN MALE SMOKERS BUT NOT FEMALE SMOKERS AGAIN PROVIDING A REASON FOR WHY MEN MIGHT HAVE A PRESENTATIONAL THERAPEUTIC RESPONSE TO NICOTINE REPLACEMENTS. WE'VE ALSO COMPLETED A MET ANALYSIS EV /KFFICACY BY GENDER. SO IN ALL OF THE PUBLISHED STUDIES, WOMEN HAD YET PRESENTED ANY BY /SWREPGENDER. NOBODY PROVIDED THE DATA. SO WE CONDUCTED A MET ANALYSIS. WE FORMED A COLLABORATION WITH FIRES AND OTHER EPACADEMIC PARTNERS AND WE WERE ABLE TO SOURCE OUT 90% OF DATA IN /TTHIS EFFORT AND ALMOST 10,000 SMOKERS IN /TH THIS ANALYSIS. SO THIS IS LOOKING AT PREVALENCE PREVALENCE. WEEK 24 AND 52 ARE FALSE APPOINTMENT AND WE SEE A FEW INTERESTING THINGS. OVERALL IF YOU LOOK AT THE RED BARS PLACEBO IS LOWER IN WOMEN THAN IT IS IN MEN. CLINICAL TRIAL REGARDLESS OF THE MEDICATION. IN THE GROUP YOU CAN SEE THAT EH RESPONSE IN WOMEN IS VERY SIMILAR TO /TTHAT AS MEN. BUT WHEN YOU LOOK AT THE RELAT RELATIVE EV /KFFICACY, RELATIVE LESS ACTIVE FOR WOMEN THAN IT IS FOR MEN AND YOU SEE THIS HERE, WHERE WE LOOK AT THE ODD RATIO SO THE TREATMENT ODDS RATIO, IS HIGH FOR WOMEN, WHICH IS HUGE. 3 AND A HALF FOR MEN. SO THIS IS THE FIRST DEMONSTRATION EVER FOR WOMEN SMOKERS WITH AN FDA-APPROVED MEDICATION. NOW, WE WERE ALSO INTERESTED IN LOOKING AT THE PRODUCT OF THESE ANALYSIS. YOU GET TO POOL SAMPLES. BUT NOBODY HAS ACTUALLY CALCULATED POWER AND WHAT WE CAN SEE HERE IS THAT FOR THE ENDO-- 82 1/2%. BUT THE OTHER FOR THE APPOINTMENT IS EXCEEDINGLY LOW SO EVEN WITH LARGE /SKPAEUFRPL DECENT NUMBER OF STUDIES GOING INTO THESE CALCULATIONS, IT'S STILL LIMIT ED ED TO LOOK AT GENDER BY MEDICATION INTER/AOBACTION. IN STRATIFIED ANALYSIS THE POWER IS STRONG SO STATISTICALLY MEDICATION BY GENDER INTER/AOBACTION. THE POWER IS STILL A BIT OF /AA CHALLENGE, EVEN WITH MET /A* META-ANALYSIS, EVEN WITH 5,000 SUBJECTS. IN ANOTHER ANALYSIS, ANOTHER STUDY THIS WAS IN COLLABORATION WITH ROSWELL PARK AND THE MINNESOTA SCORE, A COLLABORATION THAT WE LED LOOKING AT THE ROSS ROSWELL PARK ITC DATA COLLECTED FROM THE U.S., CANADA, UK AND AUSTRALIA IN /THIS LARGER DATA OF SMOKERS, ABOUT 1,000 HAD ATTEMPT ED ED TO QUIT OVER /THE /TKAUDATA WITH AND WITHOUT MEDICATION. SO WHAT WE ARE /SHAOERG IS THAT IN UNMEDICATED SMOKING SCESSATION ATTEMPTS, THAT WOMEN WERE 41% LESS LIKELY TO QUIT COMPARED TO MEN. WHEN MEDICATIONS WERE USED, THAT /TKHEUFS IS ATTENUATE ED HED HAD, NOT HE WIELIMINATED, AND THIS IMPROVEMENT WAS PRIMARILY DRIVEN BY THE USE OF MEDICATION. DIFFERENCE. WE'VE ALSO CONDUCT THE FIRST SYSTEM /AATIC REVIEW IN MET /A* META-ANALYSIS OF HORMON EFFECT ON A NUMBER OF SMOKING-RELATED OUTCOMES AND THIS WAS A COLLABORATION WE DID WITH THE MINNESOTA AND THE SCORES. AND WHAT WE IDENTIFIED HERE IS THAT WITH REGARDS TO WITHDRAWAL AND CRAVINGS, THAT WOMEN REPORT REPORTED GREATER WITHDRAWAL AND GREATER CRAVING DURING A LINEAR PHASE COMPARED TO A /SHRAEURBG PHASE. THERE WAS INSUFFICIENT DATA TO MAKE CONCLUSIONS ABOUT SMOKING, ABOUT SCESSATION, ABOUT RE/HRALAPSE AND ABOUT INTER/AOBGACTION S WITH MEDICATION RESPONSE. SO CLEARLY, MORE RESEARCH IN THESE AREAS ARE NEEDED. SO THOSE ARE THE ISSUES OF CO- CO-MORBIDITY. WE PROVIDE THE LATEST POPULATION SPECIFICS FOR THE RELATIONSHIP BETWEEN MENTAL ILLNESS TO SMOKING, HIGHLIGHTING KEY GENDER DIFFERENCES IN THESE RELATIONSHIPS. WE'VE ALSO -- THIS PAPER HERE IS THE PAPER TO LOOK AT HOW THOSE WITH MENTAL ILLNESS RESPOND TO POPULATION LEVELS -- TOBACCO, POLICY INTERVENTION. AGAIN DEMONSTRATING IMPORTANT INTERACTIONS BETWEEN GENDER ACROSS PSYCHIATRIC DIAGNOSIS AND HOW /SPHROERBGZ DEUCE SMOKING IN RESPONSE TO CHANGES IN TOBACCO TOBACCO-RELATED POLICIES. BUT THE MAJORITY OF OUR WORK IN THIS AREA BETWEEN DEPRESSION AND SMOKING RELATIONSHIPS. SO IN AN EARLIER STUDY WE DEMONSTRATED THAT THESE ASSOCIATION S WIS WITH MUCH STRONGER FOR WOMEN THAN FOR MEN AND IN THIS RECENT ANALYSIS SHOWING THAT DEPRESSION STATUS REDUCES QUICK RATES AND INCREASES RATE OF RE/HRALAPSE AND BECAUSE WOMEN HAVE TWICE THE RATES OF pDEPRESSION THAN M EN, WOMEN MORE AFFECTED BY THESE RELATIONSHIPS. SO COMPLETEED A REVIEW DEMONSTRATING THAT GENDER IS NOT CONSIDERED IN TREATMENT RESEARCH IN DEPRESSED SMOKERS. SO AGAIN, OF THE STUDIES WE IDENTIFIED, THERE WAS GOOD REPRESENTATION. THE FEMALES IN THE SAMPLES SO THAT 19% OF THE STUDIES CONTROLLED FOR GENDER -- AND I ALMOST THINK THIS IS WORSE THAN ACTUALLY STUDYING GENDER AT ALL BECAUSE YOU ARE RECOGNIZE THERE IS A DIFFERENCE AND YOU ARE WASH WASHING THE VARIANCE WAY. ONLY 7 STUDIES, 10% STUDIED INTER/AOBACTIONS BETWEEN GENDER AND SMOKING SCESSATION OUTCOMES. SO MOVING ON TO NEGATIVE ASPECTS AND EXPRESS. ACROSS SEVERAL LABORATORY STUDIES WE DEMONSTRATED THAT WOMEN ARE MORE IM/PABPACTED BY NEGATIVE AFFECTS IN STRESS. HERE WOMEN HAVE SHORTER LATENCE LATENCEIES TO START SMOKING. AND IN /THIS EARLIER STUDY WE LOOKED AT LIFE EVENT /STKWRERBGS SHOWING THAT IN PARTICULAR FINANCIAL EVENTS ASSOCIATED WITH THE FAILURE TO QUIT SMOKING IN WOMEN AND INCREASED RATES OF RE RE/HRALAPSE ATE WHOPPING 15 ODDS. AND AT A WHOPPING. AND HEALTH EVENTS INCREASED THE ODDS ACCORDINGLY IN MEN. MEN ARE MORE LIKELY TO HAVE A HEART ATTACK AND MORE LIKELY TO QUIT. THIS WAS NOT SHOWN IN WOMEN. WE REPRESELICATED THIS FINDING RECENTLY SHOWING THAT AMONG THESE STRESS, IT REDUCES RATES OF QUITTING FOR BOTH WOMEN AND MEN. BUT AGAIN FINANCIAL DIFFICULTY COME OUT OF PARTICULARLY KEY STRESSORS FOR WOMEN WITH REGARDS TO /REDUCEING THEIR ABILITY TO QUIT SMOKING. WE'VE ALSO EXTENDED THIS FINDING BY EXAMINING INTERACTIONS WHICH HELPS WITH DIVERSITY. SO WE SEE THAT LIFE EVENT STRESS INTERACT MORE SO FOR WOMEN THAN FOR MEN IN REDUCING QUIT RATE SO TIME PROVE SCESSATION RATES FOR WOMEN, STRATEGIES NEED TO ADDRESS FACTORS THAT CONTRIBUTE TO DIFFICULTY IN QUITTING. AND IN THE PIECE WE'VE BEEN DETERMINING STRESS FOR ACTIVITY AND TARGETING THE NEWUROJEGENIC SYSTEM FOR MEDICATION DEVELOPMENT. SO WE KNOW THAT NEWUROGENETIC PATHWAYS ARE INVOLVED, INCLUDING NICOTINE, AND ARE /SHROFLD IN STRESS-INDUCED FUNCTIONING. MANY SO THE WORKING SCIENTIFIC HYPOTHESISIF FOR OUR SCORE THAT OUR THREE PROJECTS IS CENTERED AROUND AS TO PROBE THE SYSTEM'S EFFECT ON STRESS ACTIVITY. HYPOTHESIZING THAT DIFFERENT BRAIN SYSTEMS MODULATED BY NEWER NEUROGENETIC ACTIVI WILL /HAOBGT VATEED BY SMOKING IN WOMEN THAN IN MEN. THE CORTEX IN MEN AND THAT AN ALPHA AGONIST OF THE PROT PROTOTYPICAL MEDICATION CAN PREVENTIONALLY TARGET THESE GEND GENDER-SENSITIVE SYSTEMS. SO I LEAD A HUMAN LAUDATORY PROJECT LOOKING ON ACTIVITY IN THE LABORATORY AND THEN DOING A BRIEF -- WHICH IS MORE OF /AA CONCEPT. AND OF COURSE LOOKING AT A NUMBER OF MECHANISMS POTENTIALLY DERLYING THE MEDICATION EFFECT EFFECT. SO WHAT THE DATA HAS SHOWN IS THAT IT IS /KWHRUL EFFECTIVE AT REDUCING IN BOTH WOMEN AND MEN SO THAT IT APPEARS TO OPERATE THROUGH DIFFERENT MECHANISMS. SO IN WOMEN WHEN YOU LOOK AT LAUDATORY RESPONSES YOU SEE STRESS COUNCIL AND SEE THAT IT HE WIELIMINATES THE STRESS WHICH IS THE /TPWAEULT -- ABILITY TO QUIT SMOKING, THAT THIS IS ELIMINATED IN WOMEN BUT NOT MEN SIMILARLY INCREASE IN THE NUMBER OF CIGARETTE SMOKES, NOT SO QUAN QUANSINE HE WIELIMINATING EFFECT IN MEN AND SIMILARLY WITH REGARDS TO TOBACCO CRAVINGS, STRESS IN INCREASE IN TOBACCO CRAVINGS. AND YOU DON'T SEE THIS IN MEN AND INTERESTINGLY, ALSO AT YALE HAS REPRESELICATED THIS CRAVING FINDING IN COCAINE USERS WITH GLAUCOMASINE. SO IN WOMEN AND MEN IT APPEARS TO BE TARGETING NICOTINE-BASED REINFORCEMENT SO SMOKING REINFORCEMENT IS REDUCED IN MEN, FOLLOWING^-- YOU DECEPT THAT EFFECT IN WOMEN. AND THIS LE DEDUCTION IN ASSESS ASSESSMENT IS ASSOCIATED WITH THEIR ABILITY TO /RESIST SMOKING. WE'VE ALSO LOOKED AT FM /R-FPRRY FUNDINGS WITH PLACEBO IN RELATION TO THE PATH WHAT YOU SEE HERE IS G INCREASES INHIBITORY CONTROL AND WHAT WE FOUND WITH WOMEN IS THAT THIS IM TO /RESIST SMOKING. SO PREFRONTAL PATH WWAY FOR MEN WAS DIFFERENT THAN THE PATHWAYS FOR MEN. LOOKING AT A/SAOESEE THEOKOHCHOLINE INTER/AOBACTIONS AND LOOKING AT /THTHAT ACROSS MODELS. SO NICOTINE RIEINFORCEMENTS. THE PROJECT IS DESIGNED TO IDENTIFY IMPORTANT BRAIN AREAS FOR THESE INTERACTIONS, AS WELL AS THEE EXTERNAL EFFECTS ON THESE INTER/AOBACTIONS AND WHAT THESE DEMONSTRATED HERE IS THAT G HAS EV /KFFICACY IN BOTH FEMALE AND MALE MICE AND THAT WHEN YOU COMBINE /TKPWHR-FPLSUACOSINE, YOU SEE A PREFERRED ANTIDEPRES-DEPRESSANT RESPONSE IN FEMALE MICE AND MALE MICE AND THIS IS A BIT OF AN ASIDE. BUT I THINK IT'S IMPORTANT TO NOTE THESE BASELINE DIFFERENCES WHICH EXIST IN THOSE MODELS. THIS IS, OF COURSE -- THE MORE TIME THEY SPEND IMMOBILE, THE WORST THE OUTCOMES. YOU SEE REDUCED IMMOBILITY. AND THIS MODEL WAS USED AS THE SCREENING FOR ANTIDEPRES-DEPRESSANT EV CAST Y AND IS USED FOR DECADES.^ BUT THERE HAS BEEN VERY LITTLE WORK IN THESE MODELS AND WE'RE NOW WORKING ON A PAPER LOOKING AT ANIMAL MODELS USED IN PSYCHE PSYCHIATRIC RESEARCH AND SAYING WHAT IS KNOWN AND KNOWN ABOUT HOW FEMALE MICE AND FEMALE AN ANIMALS MIGHT RESPOND IN THESE MODELS. S LOOKS AT AND THIS SET / FIGPHYTOSTIGMA, WHICH MIMICS THE COR NO JGENIC AND FOLLOWING NICO NICOTENIC UPREGULATION. SO YOU SEE THAT G /UACOSINE IM IMPROVED RESPONDING. SO INCREASES AND DECREASES A MOBILITY TIME WITH SIMILAR EFFECT FOR BOTH FEMALE AND MALE MICE. IN /THIS STUDY LOOKING AT KNOCK KNOCKOUT MOUSE AND WHETHER THE AFFECTED G /UACOSIGN IN THE A A/PHEAMIG DULLA INCREASES TIME AND THIS IS ATTENUATED TO KNOCKOUTS AND SO THE CONCLUSION IS THAT THE EFFECT OF G /UACOSIGN IS DEPENDENT AND IN /THIS EFFECT IS SIMILAR ACROSS MALE AND FEMALE MICE. JUST CONCLUDED A PILOT PROJECT. SO WE'RE INTERESTED IN EXPLORING THE CELLULAR UNDERPINNINGS AND FINDINGS. SO WE'VE RECRUITED MIKE HICKORY TO COMPLETE A PILOT PROJECT. MIKE IS A PROMISING CLOWNING INVESTIGATOR AT YALE. ALREADY HAS SCIENCE PUBLICATIONS TO HIS CREDIT. HUSBAND RESEARCH IS FOCUSED ON RECORDING ELECTRICAL CURRENTS FROM SINGLE CELLS AND DURING OUR INITIAL MEETING WITH MIKE, THIS WAS SAID IN THE MEETING. SEX DIFFERENCES IN BASIC AN TOM TOMICAL STRUCTURE AND FUNCTION DO NOT EXIST IN MIKE /A'S WORK, WHAT HE'S DOING IS RECORDING CELL RECORDINGS FROM MALE CELLS OR CELLS FROM SEXUAL /HRLY IMMATURE ANIMALS SO YOU DON'T KNOW WHETHER THEY'RE FEMALE OR MALE ANIMALS AND THEIR VIEWPOINT IS SINCE THEY'RE SEX SEXUAL /HRLY IMMATURE, THAT THERE ARE NO SEX DIFFERENCES. SO AFTER SOME CONTINUED DISCUSSION WITH MIKE, WE DID CONVINCE HIM THAT SEX TYPING OF ANIMALS WOULD BE A GOOD THING AND WOULD BE WORTHWHILE AND IMPORTANT. SO PEOPLE WANT /TO CONDUCT GOOD SCIENCE. SO THIS IS HOW WE WERE ABLE TO CONVINCE HIM. AND SO LIKE I SAUD, HE RECORDS FROM SINGLE CELLS IN THE PRE PRE/TPWROPBL CORTEX AND SHOWN THAT INCREASES TRANSMISSION. AND WE LOOK AT /T IMPORTANT BECAUSE THE WORK FROM AMY AT YALE HAS SHOWN THAT G /UACOSIGN REALLY COUNTERACTS THE CONDUCT CONDUCTIVITY BETWEEN THE FIRINGS AND IMPROVING THE CONNECTIVITY HAS A BEHAVIORAL OUTCOME OF IM IMPROVING HOPES OF RESPONDING. SO AGAIN, INTERESTED IN SEEING WHAT THE CELLULAR UNDERPINNINGS OF THESE /-FBGT ARE. SO MIKE IS RECORDING -- WHAT HE'S PRODUCING IN THE DATA IS THE RATIO BETWEEN THE MDA AND THE AMPA VOLTAGE AND HE'S SHOWING THAT -- HE'S REPLICATED HIS FINDINGS SO IT INCREASES EXCITETRY TRANSMISSION AND THERE WERE SEX DIFFERENCES IN HIS RESPONSE, THAT FEMALES SOARED THROUGH THAT FINDING. IF YOU LOOK HERE, THAT IT'S REALLY THE FEMALES DRIVING THIS SION IN THE PSC. DIFFERENCE IN EXCITETRY SO AGAIN, OUR SUPPORTING HYPOTHESIS THAT WE THINK THAT GU GUACOSIGN BY FOCUSING ON THE PRE PREFRONTAL PIECE OF THE PATH WWAY. WE'VE DONE OUR IMAGING PROJECT, WHICH IS FOCUSED ON LOOKING AT MALE AND FEMALE SMOKERS AND HOW ALTERS THAT RELEASE AND SINCE SHE AND I SHARED SUBJECT, WE'RE ALSO GOING TO BE ABLE TO COMPARE AND CONTRAST THE LAUDATORY. AND THIS IS DATA THAT SHE'S NOW ANALYZED AND SHOWING THAT G A ATTENUATES DOPAMINE RESPONSE IN EXTRACELLULAR REGIONS, INCLUDING THE CORTEX. SHE DID NOT WANT /TO PRESENT HER DATA BY SEX AT /TTHIS POINT. SHE THOUGHT IT WAS PRELIMINARY BUT IS LOOKING GOOD AND EN ENCOURAGING. NOW WITHIN THE MIRROR IMAGING UMBRELLA, WE'VE ALSO FUNDED ELLEN MOORE TO COMPLETE ANOTHER PILOT PROJECT. AND EVAN HAS AGAIN -- HE'S THE MATH /PHEMATICAL GENIUS AND HAS DEVELOPED TECHNOLOGY TO IMAGE OCCURS -- OWCCURRING DURING SMOKING SO THIS REALLY REPRESENTS A QUANTIUM LEAP FOR IMAGING TECHNOLOGY AND FUNDED HIM TO LOOK AT SEX DIFFERENCES DURING SMOKING SO HERE IS THE /SUPBT IN THE CAMERA SMOKING A CIGARETTE HOLDING THE ASHTRAY NOW WHAT I AM GOING TO POINT OUT IS WHAT EVAN CALLS HIS DOPENING. YOU CAN SEE THE ACTIVATION OF DOPMINE IN A MALE AND A FEMALE SUCK THE. YOU DON'T SEE THIS DURING THE REST OF IT. I AM GOING TO LET THIS LOOP AROUND ONE MORE TIME SO YOU CAN SEE IT AGAIN. SO AT ABOUT THE 40-MINUTE MARC GOING TO SEE ACTIVATION COMING UP. AND WHEN EVAN QUANTIFIES THIS, WHAT HE SHOWS IS THAT MEN RESPOND CONSISTENT LY AND RAPIDLY RAPIDLY, WHEREAS WOMEN RESPONDS IN THE SUBREGION OF THE DORSO AND MEN ACTIVATE MORE THAN WOMEN WOMEN. FITS WITH THE HYPOTHESIS THAT MEN ARE SMOKIN FOR MOR -- MORE FOR NICO-TYPE-BASED RIN STORM AND THE FOR WOMEN IT'S MORE CONSISTENT WITH THE IDEA THAT WOMEN SMOKE FOR NON-NICOTINEIC REONS AND /PRAEPS REACTIVITY IN /THIS SITUATION. EVAN HAS ALREADY HAD A RO1 PENDING. SO THIS IS JUST PRESENTING A SNAP SHOT OF SOME OF OUR PROJECTS THAT SPAN THE T 1 TO T 4 TRANSLATION. OUR RESULTS FROM THE PRIMARY PROJECTS SO /TPFAR CONTINUE TO HIGHLIGHT THE IMPORTANCE OF BOTH GENIC SYSTEMS IN THE NOR -- NEW UNDERSTANDING AND TREATING TOBACCO DEPENDENCE OUR SYSTEM /AATIC META-ANALYSIS ARE DESIGNED TO HIGHLIGHT THE STATE OF THE RESEARCH AND TO IDENTIFY GAPS IN OUR KNOWLEDGE AND OUR ULTIMATE GOAL ACROSS ALL THIS WORK IS TO IN/TPORFORM AND EX/PE EXPEDITE THE DEVELOPMENT OF GEND GENDER-SENSITIVE THERAPEUTICS AND I ALSO WANT /TO MENTION THAT ACROSS ALL THIS WORK WE MENTOR RCH SCHOLARS. 18 TRAINEES, INCLUDING 4 OF OUR SO I WAS ALSO ASKED TO PRESENT WHAT I'VE LEARNED ABOUT DOING SEX DIFFERENCE RESEARCH AND I THINK WHAT I AM GOING TO SAY HE CECHOES WITH WHAT HAS BEEN SAID HERE TODAY IS THAT TO CONDUCT THE SCIENCE, WE NEED TO INCLUDE SEX IN /AA COMPREHENSIVE AND MEANINGFUL WAY SO THAT STUDIES NEED EQUAL REPRESENTATION AT SUCH NUMBERS TO TEST FOR SEX AND GENDER /TKHEUFSS. IT'S ALSO IMPORTANT TO FORM STRATEGIC PARTNERSHIPS AND WE'VE DONE THIS WITH BOTH ACADEMIC PARTNERS AND IN ORDER TO GAIN ACCESS TO DATA TO COME TO A BETTER CONCLUSION, A BETTER RESEARCH AREA. AND AS WE SAW WITH THE CASE I HIGHLIGHTED IN THE SURGEON GENERAL'S REPORT YOU NEED TO BE STOCK FULL OF DATA AND AN UNDERSTANDING OF HOW MEN AND WOMEN MAY DIFFER AND TO BE THOUGHTFUL AS TO HOW YOU PUT YOUR DATA TOGETHER IN ORDER TO BE ABLE TO LOOK AT /TTHAT. YOU ALSO NEED TO BE AN /AFADVOCATE FOR GOOD SCIENCE. THAT WE IDENTIFY PROMISING AND TALENTED SCIENTISTS AND TRY TO RECRUT THOME OUR MISSION TO CONDUCT SEX DIFFERENCE RESEARCH. AND WE THINK -- WE'VE BEEN SUCCESSFUL AT BEING ABLE TO DO THAT. I ALSO /STOFRD THAT YOU NEED TO ARGUE A LITTLE BIT WITH THOSE GRANT REVIEWERS AND GENERAL -- JOURNAL HE HEDITORS ABOUT THE NEED TO HIGHLIGHT SEX AND GRANT APPLICATIONS AND RESEARCH PAPERS PAPERS. SO THESE ARE JUST TWO VERY RECENT HE HEDITOR COMMENTS THAT I RECEIVED, BOTH THROUGH E-MAIL. I'LL LET YOU READ THE E-MAIL. CAN EVERYBODY READ THAT? SO THE FIRST ONE. /SKWHREPBD ER DIFFERENCES COULD BE IMPORTANT BUT COULD NOT BE IN RELATION. THIS WAS THE NEW JOURNAL. I SENT THEM THE ABSTRACT AND SAID WE'D BE INTERESTED. THIS ISSUE IS WHETHER THERE IS A COMPELLING LEAN FOR LOOKING AT THESE DIFFERENCES. THIS SEEMS HAD THE DATABASE VARIABLE SETTING -- /SAOFR A COUPLE OF E-MAIL EXCHANGES, THIS BECAME WITH IS NOW IN REVISION AT THE JOURNAL. SO HOPEFULLY IT WILL HAVE A GOOD OUTCOME. IN /THIS CASE HERE, THIS WAS A PAPER WE SUBMITTED AND THIS WAS IN RESPONSE TO OUR FIRST MISSION MISSION. "I RECOMMEND THAT YOU CONSIDER REMOVING THESE GEND RIGHT- RIGHT-SPECIFIC ANALYSIS FROM THE BECAME IF YOU WOULD /HRAOEULIKE TO HAVE IT CONSIDERED FURTHER FOR PUBLICATION". SHOAGAIN, IF YOU WANT E-MAIL EXCHANGES. SO STILL THE GENDER ANALYSIS INCLUDED AND WITH THE GENDER FOCUS. SO AGAIN, HAVING TO BE AN /AFBD ADVOCATE FOR GOOD SCIENCE. AND LASTLY, AS WE KNOW, YOU HAVE TO PROVIDE RESOURCES TO SUPPORT THE SEX DIFFERENCE RESEARCH AND WE DO THIS BY PROVIDING SALARIES SUPPORT, INCLUDING TRAINING MECH MECHANISMS AND THE BIRCH WAS INSTRUMENTAL IN /THIS. WE ALSO PROVIDE /SKHULGS TO INVESTIGATORS ON PAPER. SO IF WE KNOW SOMEBODY HAS SOME FABULOUS DATA, IF THEY HAVEN'T LOOKED TAT YET BETTER TO SEX AND GENDER AND WORK WITH THEM TO DEVELOP THE PAPER, WE ALSO HAVE WORKED WITH INVESTIGATORS IN CONSULTATION TO THE GRANTS AND AS WE'RE HELPING THEM WITH THE GRANTS, WE ENSURE THAT SEX IS INCLUDED IN /AA MEANINGFUL WAY AND THAT THEIR METHODOLOGY IS DESIGNED SUCH THAT THEY WILL BE ABLE TO EXAMINE SEX DIFFERENCES DOWN THE ROAD. AND WE ALSO PROVIDE RESEARCHERS WITH OPPORTUNITIES TO DIS DISSEMINATE. CURRENTLY HE HEDITING AN ISSUE IN LARCH WHEN WE'VE HAD INSLIGHT ED HAD TOBACCO -- SOME VERY SENIOR SCIENTISTS TO BE PART OF THAT ISSUE. AND THESE INDIVIDUALS COULD NOT OVERLOOKING THEIR DATA FOR SEX AND GENDER AND TO BE PART OF THE ISSUE OF COURSE REQUIRES THEM TO DO SO. AND AGAIN, WE'RE RECRUITING /KROUGT MORE PEOPLE TO OUR /PWHEUGS. SWO, I WANTED TO ALSO SHOW YOU THIS IN THE LAST SLIDE. CAROLYN IS /THE DIRECTOR OF WOMEN'S HEALTH RESEARCH AT YALE AND THE SCIENTIFIC DIRECTOR ON OUR T 50 AND CAROLYN DEVELOPED A PROGRAM AT YALE AND AS PART OF HER EARLY HON IN THE PROGRAM SHE STARTED PROVIDING PEOPLE WITH PILOT FUNDS TO CONDUCT SEX AND GENDER RESEARCH AT YALE. AND OVER /THE COURSE OF 1988 SHE PROVIDED ABOUT $4.7 MILLION AND /HAOEPZ -- THESE INVESTIGATORS HAVE NOW GONE OUT AND SECURED EX EXTHAT MURAL FUNDING IN HOW THE OF $7 MILLION -- $/1K357 THIS RESEARCH INCLUDES SEX AND GENDER IN /AA MEANINGFUL WAY. $57 MILLION. WITH THAT, I'LL JUST END. I AM SO APPRECIATIVE OF THE FUNDING AND THE OPPORTUNITY FOR US TO DO THIS WORK. IT'S REALLY PROVIDED US WITH A SCIENTIFIC HOME FOR THIS WORK AND I'LL STOP THERE AND SEE IF THERE IS ANY QUESTIONS. /PHRA [APPLAUSE] >> SO THEN JOHN AND THEN JILL. >> JUST /AA QUICK QUESTION. WHEN I TALK TO HE HEDITORS OF JOURNALS ABOUT MY ARTICLES, I DON'T ALWAYS GET THE RESPONSE " "SURE, WE'LL CHANGE IT." HOW DID YOU ASSESS THAT CHANGE? THAT'S A GOOD DEAL GETTING HE HAD TORS TO UNDERSTAND THE IMPORTANCE? >> WHAT WE DID IN THE FIRST CASE WITH THE ABSTRACT, I -- I'LL -- THIS PERSON IS PAST PRESIDENT OF APA. SO A VERY INFLUENTIAL PSYCHOLOGIST, AND SO I WAS ABLE TO TALK WITH MIM THAT IT WAS IMPORTANT FOR ME FOR THE PAPER TO HAVE A PRIMARY GENDER FOCUS, BECAUSE THAT'S WHAT THE LITERATURE IS SUPPORTING. THAT THAT'S WHERE OUR FINDINGS SUPPORT AN AFTER I HAD SAUD THAT IN THE E-MAIL, THE NEXT E E-MAIL -- I SHOULD MAYBE HAVE PUT UP -- OF COURSE, SEX IS IMPORTANT. SO HE'D KIND OF BACKTRACKED A LITTLE BIT. LUKE I SAID, THE PAPER IS UNDER REVISION, SO WE'RE HOPEFUL IT WILL EVENTUALLY GET PUBLISHED. >> I WAS GOING TO SAY DO YOU HAVE THE EXCHANGE WITH THE NAME REVIEW ER BEFORE OR AFTER THE CONGRATULALAYTON IN NATURE? >> THESE WERE BEFORE. BOTH OF THESE OCCURED BEFORE THAT. >> I PROBABLY -- IT PROBABLY WOULD HAVE GONE DIFFERENTLY AFTERWARD. >> PERHAPS. >> QUICK QUESTION. THE HE HEDITOR AND STRESS LEVEL OF THE POPULATION IN THE UNITED STATES CERTAINLY WENT UP BY MANY FOLD AT 2007 DURING THE LATE RECESSION. I'M WONDERING IF YOUR MET ANALYSES MIGHT HAVE PICKED UP A DIFFERENTIATED CHANGE IN SMOKING SCESSATION RATES OVER TIME THAT MIGHT REFLECT THAT -- WHAT I'M CONSIDERING IS A VERY BIG FACTOR FACTOR, A BIG VARIABLE FOR FEMALES IN PARTICULAR. >> THAT IS AN INTERESTING IDEA. I HADN'T THOUGHT ABOUT TRACKING THAT IN RELATION TO SORT OF FINANCIAL HEALTH OF THE COUNTRY BUT THAT'S AN EXCELLENT IDEA, AND I'LL PUT PHIL ON IT. >> I AM TOTALLY EXCITED ABOUT THE DATA YOU PRESENTED ON THE DOPAMINE IMAGING. MY WORK IN RATS HAS SHOWN THAT ACTING IN THE DORSAL LATERAL STRIDEUM RELEASED AND NADIUM THE VENTRAL. SO IT GOES -- >> I'D LOVE TO BE ABLE TO CITE IT ON THE GRANT PROPOSAL I'M CURRENTLY SUBMITTING. LAUGHT[LAUGHTER] >> EVAN, I'LL GET IN TOUCH WITH THEM. THEY JUST SUBMITTED THE PAPER TO, I THINK, THE JOURNAL OF NEWUROSCIENCE FOR PUBLISCATION. BUT HE HAS PRESENTED THIS BEFORE AND PRESENTING IT AT THE OR WH MEETING IN NOVEMBER BUT I'LL PUT YOU IN TOUCH WITH HIM. >> CARMEN? >> SO GREAT PRESENTATION. I REALLY ENJOYED IT. WHEN YOU WERE DOING YOUR ANALYSIS HAS, I JUST WONDER WITH THE INCREASING DIVERSITY OF WOMEN, DID YOU ACTUALLY TAKE A LOOK AT MINORITY WOMEN AND WHAT DID YOU FIND? >> WE DID LABORATORY STUDY AND WE HAVE ABOUT 50% MINORITY RATES IN OUR LABORATORY STUDIES AND WE DO NOT SEE DIFFERENCES. IN THE MET /A-ANALYSIS, WE DID NOT HAVE ACCESS. LET ME SAY WHICH /WUONE YOU'RE ASKING ABOUT OR JUST GENERALLY? NO. YOU'RE CORRECT. RIGHT. SO WE WERE NOT ABLE TO LOOK AT THAT IN A MET /A-ANALYSIS, JUST BECAUSE OF THE LACK OF ACCESS TO THE DATA AND WHAT'S PUBLISHED IN THE JOURNAL ARTICLES. WE DID LOOK THE IT IN THE REVIEW PAPERS, WHERE IT'S REPORTED. FOR BOTH THE DEPRESSION REVIEW AND THE MEDICATION REVIEWS. >> I /TKPWGUESS I MEAN THE SCORES. AND DR. CONGRATULALAYTON AND YOUR TEAM -- WE'VE GOT AN /EUINCREASING LLY DIVERSIFYING POPULATION AND YOU NEED TO BE CONGRATULATEED IN REGARDS TO BRINGPING OVERSAMPLE HIGHWAY IN YOUR EXPERIMENTAL STUDIES. BUT ONE OF THE CONVERSATIONS THAT ALSO NEEDS TO BE HELD ABOUT INCLUDING THINGS THAT WE ARE INCLUDING WOMEN IN /THIS CONVERSATION IS ALSO LOOKING AT THE ROLE OF THERAPIES IN MINORITY WOMEN, BASICALLY AS THEY START TO INCREASE IN THE MAJORITY. AND -- THE AND. IN THE CONTEXT OF THE FACT THAT THEY ARE DISPROPORTIONATE LY LIKE LIKELY TO EXPERIENCE LUNG CANCER CANCER. >> ABSOLUTELY AND ALSO WE KNOW THAT WOMEN OF COLOR HAVE THE GREATEST DIFFICULTY IN QUITTING SMOKING. ABSOLUTELY. >> INAUDIB[INAUDIBLE]. FOR SMOKING CIGARETTES ON MINORITY WOMEN AND THAT THROUGH GLOBAL LY THERE IS MORE MARKETING AND ADVERTISEMENT THAT'S GOING ON. >> CAMERON? >> I'M JUST CURIOUS FROM YOUR EVEN -- OWN EVALUATION, WHAT ROLE INSTITTIONAL SUPPORT PROGRAM INAUDIB[INAUDIBLE] I THINK THAT MOST DONE HAVE THAT -- >> CAN YOU REPEAT THE /HRALAST PART PART? I DIDN'T QUITE CATCH IT. >> I'M CURIOUS WHAT RELATIVE ROLE THAT INSTITUTIONAL SUPPORT FOR THE PROGRAM ON SEX DIFFERENCES HEAD -- HAD ON THE OVERALL SUCCESS THAT YOU SHOWED US? >> SORRY, I'M -- >> INAUDIB[INAUDIBLE]. >> HOW DO I SAY THIS? >> INAUDIB[INAUDIBLE]. >> YES, THEY ARE HAPPY FOR IT, YES. THEY PROVIDE ME WITH A OFFICE AND A TITLE, SO YEAH. >> BUT IT'S ALMOST LIKE WHEN I LOOK AT THESE NUMBERS SUPER LY THAT LOOKS LIKE A DOUBLING OF YOUR BUDGET. YOU HAVE THAT -- >> IN TERMS OF THE PRIVATE. SO WE'VE BEEN SUCCESSFUL IN TERMS OF THE OTHER INVESTIGATORS THAT DEVELOP SPIN-OFF GRANTS, TRAINING MECHANISMS TO SUPPORT JUNIOR PEOPLE TO SORT OF EXPAND THE BREADTH OF THE WORK THAT WE'RE DOING. SO WE'RE GOING TO -- WE'VE BEEN CREATIVE IN HOW WE WERE ABLE TO -- >> INAUDIB[INAUDIBLE]. >> I WOULDN'T BE -- WITHOUT THE SCORE. YES. ABSOLUTELY. >> I THINK FOR THE FUTURE, I WISH WE ALMOST HAVE TO BE /AA CONDITION FROM -- TO INSTITUTION INSTITUTIONS MAKE THAT KIND OF COMMITMENT TO SUPPLEMENT. >> BUT IT WAS WRITTEN IN THE R RFA, YES. >> HEX MANDING POWER THERE, BOY. OR >> ON THAT NOTE, I THINK WE WILL GHEAD AND CLOSE OUR MORNING SESSION. THANK YOU VERY MUCH, DR. MCKIE. /PHRA [APPLAUSE] >> AND WE WILL TAKE A LUMP AND PLEASE BE BACK PROMPTLY AT 1:15. THANK YOU VERY MUCH. SO WE'RE GOING TO RESTART OUR AFTERNOON SESSION OF THE 38th ADVISORY COMMITTEE ON RESEARCH HEALTH MEETING AND I'M DELIGHTED TO WELCOME OUR FIRST SPEAKER FOR THE AFTERNOON. DR. TERESA WOODRU FF, S&P WITH REPRACTICES DUCTIVE SCIENCE AND MEDICINE ASTERISKS THE FIBER SCHOOL OF MEDICINE AND PROFESSOR OF MOLECULAR BIOSCIENCES AT ARTS AND SCIENCES AT NORTHWESTERN. SHE IS FROM NORTHWESTERN AND WE'RE DELIGHTED TO HER HERE. SHE IS AN INTERNATIONALLY RECOGNIZE EXPERT IN OVARIAN BIOLOGY AND COINER OF THE TERM ONK O FERTILITY SO THAT'S AN EXCITING NEW FIELD THAT IS THE MARRIAGE OF ONCOLOGY AND FERTILITY. ONE THING I WANT SHOW YOU FROM DR. WOODRUFF BEING THE FOUNDING DIRECTOR OF WOMEN'S INSTITUTE AT NORTHWEST CERN THAT SHE'S DEDICATED TO MENTORING AND MENTORING A WIDE RANGE OF GIRLS AND WOMEN AND HAS DONE SOME AMAYING THINGS IN THAT REGARD. AND ONE OF MY VISITS I GOT TO SEE FIRST HAND HER INCREDIBLE DEDICATION TO THAT AREA. SO WITHOUT FURTHER ADIEU LET ME WELCOME HER. >> THANK YOU. I'M GLAD TO BE HERE. MY CHARGE FOR THIS AFTERNOON IS TO BEGIN A CONVERSATION ON THE KINDS OF TOOLS WE'RE GOING TO NEED FOR IMPLEMENTATIONS AND SO THE POLICY IS BEGINNING TO BE ETCHED AND NOW WE WANT TO TAKE THIS TO THE NEXT LEVEL OF WHAT ARE WE GOING TO NEED TO BE ABLE TO MOVE FORWARD WITH THIS AND I KIND OF THINK JUST BY WAY OF PBLE OF THE NEXT FEW MINUTES THAT THIS IS KIND OF MIDPARAGRAPH. SO FOR MANY OF YOU IN THE ROOM. VALAR SCHEOTHER WHO IS HAVE BEEN AT OTHER TALKS LIKE THIS, I'VE BEEN GIVING A TALK ON FOSTERING INCREASED AWARENESS OF THE SEX DIFFERENCES AS HAVE ALL OF YOU. AND WE HAVE OVER THE LAST SEVERAL YEARS PUT TOGETHER A PORTFOLIO OF TASKS THAT WE NEEDED TO ENGAGE IN, IN ORDER TO GET TO THE POINT THAT WE NOW HAVE THIS--THE POLICY STATEMENTS FOR REALLY THIS IMPORTANT NEXUS IN OUR HISTORY AND AS I REVIEW THOSE LAST--THOSE TALKS I REALLY REALIZE THAT A LOT OF THE ADVOCACY THAT HAD TO GO INTO PLAY, A LOT OF THE EVIDENCE BASED GATHERING OF DATA THAT REPRESENTED WHAT THE TRUE PICTURE WAS OF SEX INCLUSION AS IT RELATED TO FINAL PUBLICATIONS. ALL OF THESE THINGS WE DID OVER THE LAST FIVE AND 10 YEARS. AND SO IT'S REALLY TO ACCREDIT TO EVERYONE IN THE ROOM THAT THIS BALANCED APPROACH TO GETTING US TO CONVERT MINDS, TO CONVERT INDIVIDUALS TO CONVERT CONGRESS, TO CONVERT STEPHEN COBAHAR, ALL OF THESE THINGS CAME INTO INEVITABILITY IF YOU WILL. WE DON'T HAVE MUCH TIME BECAUSE WE DON'T HAVE A POLICY YET THAT BE IMPLEMENT INDEED A WAY THAT FOLKS WILL HAVE THE KIND OF PUSH BACK THAT WE'VE BEEN HEARING ABOUT ON THE COST SIDE OR THE RATIONAL SIDE. SO, YOU KNOW I CREATED THIS TALK TO KIND OF BEGIN A CONVERSATION AND I THINK IT WILL GET HONED EVEN MORE THAT IS WE GO FORWARD AND WHAT YOU MEAN AFTER THIS IS JUST TO KIND OF SURVEY WHAT'S OUT THERE, WHAT DO WE KNOW AND WHAT KIND OF TOOLS COULD BE USEFUL AND WHERE MAYBE ARE THE GAPS THAT WE CAN BEGIN TO PUT THINGS TOGETHER. SO I'LL START WITH THE MIND THE GAP WHICH IS THAT AND I HEARD FRANCIS COLLINS ON MY CELL PHONE THIS MORNING AS I WAS COMING IN AND HE WAS TALKING ABOUT THE FACT THAT WE'RE IN A UNIQUE TIME AND IT IS TRUE WE'RE SIT NOTHING A TIME OF COLLIDING EPIDEMICS OF THINGS LIKE DIABETES, OBESITY, SERIES OF SILENT KILLERS AND NOT SO SILENT KILLERS, INFECTUOUS DISEASES, SEXUALLY TRANSMITTED DISEASES, EBOLA ABROAD IF THAT BECOMES MORE MOBILE ACROSS THE GLOBE THAT WILL BE AN INCREDIBLE PRESSURE ON ALL OF US. THERE'S PRESSURES ON THE HEALTHCARE SYSTEM THAT ARE REMARKABLE ACROSS THE EXPOS SEEING AN EVEN DISTRIBUTION OF CARE DESPITE THE ROLL OUT OF ACA AND I THINK I AM ECHOING WHAT I HEARD THIS MORNING THIS IS A TIME OF TREMENDOUS NEED BUT ALSO A TREMENDOUS OPPORTUNITY AND THIS IS WHERE WE COME IN TO SPAN THAT NEED GAP AND TAKE ADVANTAGE OF THE OPPORTUNITY THAT WOMEN HAVE BEEN LARGELY UNDER REPRESENTED IN STUDIES AND THEREFORE REPRESENT A GOOD TARGET OF OPPORTUNITY FOR THE MONEY THAT WE HAVE SO WHEN THAT COMES UP IN MY TALK AND TELL AS MUCH AS LATER AND IT'S JUST THE ECONOMIC OF THIS ARE AN IMPERATIVE THAT WE HAVE TO INCLUDE FEMALES IN BASIC SCIENCE AND THE WOMEN IN THE EQUATION OF CLINICAL STUDIES BECAUSE THAT'S WHERE THE BIGGEST NEED IS AND WHERE OUR BIGGEST BANG FOR EVERY NIH AND CLINICAL PHARMA DOLLAR CAN GO. I THINK SCIENCE KNOWLEDGE GAP HELPS IMPACT HEALTH AND DECISIONING AND THIS IS IN DIFFERENT WAYS, ONE S&P THAT WOMEN WHEN WE GO IN TO SEE OUR DOCTORS WE'RE NOT OUR OWN ADVOCATES. WAS THIS DRUG TESTED ON ME, THIS WAS DEVICE TESTED ON FEMALES AND THAT'S SOMETHING WE HAVE GOT TO CHALLENGE OURSELVES TO BECOME MORE ADVOCATES FOR OURSELVES AND MEN MORE ADVOCATES FOR WOMEN AND THEREFORE FOR BETTER HEALTH FOR ALL OF US. SO THESE REPRESENT SOME OF THE MAJOR, I THINK FRAMING ISSUES OF THE TIME IN WHICH ALL OF THIS IS SET, AND I THINK THAT I ALSO ECHO MANY OF YOU IN THE ROOM WHEN I SAY THAT WE ARE TALKING ABOUT WOMEN BECAUSE THAT'S WHERE THE GAP IS, BUT THIS IS REALLY IMPORTANT TO ALL SEXES, TO BOTH SEXES, TO ALL SEXES THIS, IS AN IMPORTANT ISSUE FOR ALL OF US BECAUSE OUR HEALTH IS ALL INEXTRICABLILY LINK WIDE WE LOOK AT CLINICAL STUDIES THAT MIXES MEN AND WOMEN AND WE'RE NOT GETTING THE BEST EFFICACY DATA BECAUSE WE MAY HAVE DIFFERENCES IN THE EFFECTIVENESS BETWEEN POPULATIONS. SO I THINK WE NEED TO BEGIN TO MAKE THESE CONNECTIONS TO FOLKS THAT UNDERSTANDING SEX DIFFERENCES TO INCLUDE SEX IS PART OF A VARIABLE JUST LIKE DOSE, TIME AND TEMPERATURE, THAT IS THE CRITICAL ISSUE OF OUR DAY AND IT MUST HAPPEN WITHOUT A DOUBT. SO I'LL START WITH THE HYPOTHESIS, I ALWAYS LIKE TO HAVE A HYPOTHESIS OF SOME SORT SO THE ONE THAT I'LL USE FOR TODAY IS THAT THE NEXT GENERATION OF BIOMEDICAL ADVANCES THAT IMPROVES THE LIVES OF ALL PEOPLE AND THIS INCLUDES DRUGS, DEVICES AS WELL AS BEST MEDICAL PRACTICES REQUIRES FUNDAMENTAL DISCOVERY AND RESEARCH THAT INCLUDES SEX AS A VARIABLE SO THAT'S THE HESIS THAT WE WILL BE TESTING OVER THE NEXT SEVERAL YEARS AS THIS POLICY BEGINS TO BE IMPLEMENTED TO SEE IF THOSE BIG CHALLENGING DISEASES, THOSE IACTABLE PROBLEMS WE ALL SEE ARE ACTUALLY MADE BETTER QUANT FIELD FUNCTIONSABLY THROUGH THE POLICY DEVELOP. SO THE OTHER THING I WILL PICK UP ON IN THE COLLEAGUES IN THE FDA IN HER TALK IS A NOTION OF A PERSONALIZED MEDICINE AND WE HEARD FRANCIS COLLINS TALK ABOUT THIS. THIS IS REALLY WHERE SCIENCE AND MEDICINE HAS TO GO. AND SO I REALLY THINK THAT PERSONALIZED MEDICINE BEGINS AT THE BENCH WITH BASIC RESEARCH AND FACTORS THAT ARE IMPORTANT TO MEDICAL CARE VARY BY INDIVIDUAL AND THINGS LIKE SEX AND AGE ARE THE MOST OVERT THINGS THAT VARY AND THOSE ARE TWO THAT WE HAVE TO BEGIN TO REAL LYE DISSECT OUT VERY CAREFULLY. AND THEN GENDER ETHNICITY, RACE, SOCIOLOGICAL ECONOMIC STATUS AS WELL AS IF WE DEFINE GENDER AND ANIMALS BY THEIR ENVIRONMENT, HOUSING, HUSBANDRY, ANIMALS WITHIN THE CAGE, ALL THESE ARE THINGS WE STUDY AT THE BENCH AND TRANSFER THEM ALONG THE WAG WAY AND I THINK IF WE GET BETTER AT MULTIVARIABLE BASIC STUDIES WE WILL GET OURSELVES TO THE POINT WHERE WE CAN DO PERSONALIZED MEDICINE. NOW FDA WILL GO WITH US BECAUSE THEY WILL HAVE DRUGS THAT ARE GOING TO BE TEST INDEED CERTAIN POPULATIONS AND NOT AFFECT INDEED OTHER POPULATIONS AND THAT WILL BE OKAY FOR SOME--FOR APPROVAL AND THAT'S NOT THE WAY WE DO DRUG TESTING AND APPROVAL RIGHT NOW. BUT I WAS VERY ENCOURAGED TO SEE PERSONALIZED MEDICINEOT BOTTOM OF THE SLIDE WHICH IS WHERE WHERE WE NEED ON GO. SO MESSAGING AS BEEN ONE OF THOSE KEY FEATURES OF THE CONVERSATION OVER THE LAST SEVERAL YEARS AND ONE OF THE THINGS THAT WE IDENTIFIED WITH IS SOMETIMES HARD TO DISSEMINATE TO THE PUBLIC EFESHTLY WHAT IT WAS WE WERE TALKING ABOUT. IT WAS TOUGH TO GENERATE THE POLITICAL CAPITAL THAT WE GOT ON THIS TOPIC IT WAS DIFFICULT TO BOIL DOWN TO ONE SENTENCE. WE CAME UP WITH AND I THINK MANY OF US WENT AROUND TO CONGRESS AND NUMBER OF CHAMPIONS FOR US AT THE MESSAGE OF SEX BASED STUDY SYSTEM SIMPLE AND THAT IS TAKEN--THEY FEMALES AND MALES DIFFER IN THEIR EXPERIENCE OF HEALTH, DISEASE AND THE TREATMENT OF THE DISEASE AS WELL AS THE SIGNED POST OF AGE AND THEREFORE, THIS IS A BIOLOGY, THAT WE SHOULD STUDY. WE HAVE TO MAKE SURE THERE ARE THREE PARTS OF THE AWNINGMENTS, THE INTELLECTUAL ARGUMENT, THE BIOLOGY OF SEX MATTERS TO THE HEALTH OF OUR NATION'S PEOPLE, THAT'S THE BOTTOM LINE. IT MATTERS, BUT WE ALSO HAVE TO HAVE THE ECONOMIC CONVERSATION AND AS YOU'RE LOOKING AT THE BLOG RESPONSES TO GERONTOLOGYSTS NINE'S VARIOUS POST AND VALLEY ROCKY'S POST, THE ISSUE COMES UP OF ECONOMICS ALL THE TIME. SO WHAT I WANT TO ARGUE IS THAT THE STUDY OF SEX BASED BIOLOGY PROVIDES A COST EFFECTIVE WAY TO INCREASE THE QUALITY AND REDUCE THE ULTIMATE HEALTHCARE COSTS AND I SAY THIS BECAUSE I BELIEVE FIRMLY THAT BASIC SCIENCE IS WHERE WE CAN GET THE BIGGEST BANG FOR OUR BUCK, WHERE WE CAN LEARN THE MOST AND IT'S FAR CHEAPER TO DO THE WORK AT THE BENCH THAN IT IS IN THE CLINIC. AND FOR EVERY MONKEY THAT WE HAVE TO STUDY, IT'S FAR CHEAPER TO DO IT AT THAT BENCH THAN WITH ADVERSE EVENTS AND POST MARKETING SURVEILLANCE SO I THINK THE ECONOMIC ARGUMENT HAS TO BE TURNED AROUND TO SAY THAT BASIC SCIENCE IS WHERE WE NEED TO PUT OUR EFFORT AND THAT THE COST INCUR SYSTEM INVAL AUTOMOBILE TO THE ULTIMATE HEALTH OF OUR PEOPLE AND THEN THE LAST BIT IS PERSONAL. WE HAVE TO MAKE THIS TANGIBLE BECAUSE AGAIN WOMEN AREN'T COMPLAINING, WE'RE NOT THE ONES SAYING WE HAVE MORE PAIN EVENTS THAN MEN. WE'RE NOT THE ONES OUT THERE SAYING THAT OUR HEART ATTACK IS NOT BEING TAKEN CARE OF IN THE SAME WAY. WE'RE NOT COMPLAINERS. AND SO WE HAVE TO MAKE SURE THAT WOMEN SEE THAT THIS IS SOMETHING WE SHOULD ASK FOR, IT'S INCOLERABLE THAT ALL OF THE BASIC SCIENCE STUDIES AND THE CLINICAL MEDICINE BEING REPORTED IN TERMS OF ONE SEX ONLY FELT SO WE HAVE TO GET THIS PERSONAL. SO THERE MUST BE SOMETHING MORE. THAN HAVING MY BABY AND WAITING FOR MY CANCER. I THINK TAKEN--THEY'S A PERSONAL STATEMENT BECAUSE THAT'S WHAT WOMEN ARE TOLD WE'RE INTERESTED IN, WE'RE INTERESTED IN WOMEN'S HEALTH AND ALMOST EVERY HOSPITAL IS ABOUT MATERNAL-FETAL MEDICINE AND BREAST CANCER HAS REALLY DONE A FANTASTIC JOB OF CO OPTING THE CONVERSATION ON WOMEN'S HEALTH. KUDOS TO THEM, I LOVER THE BREAST CANCER COMMUNITY AND WE HAVE TO TAKE A PAGE OUT OF THAT ADVOCACY COMMUNITY IN ORDER TO MOVE THIS FORWARD. SO IS EVERYBODY WITH ME ON THIS, THE INTELLECTUAL AND PERSONAL ORGMENTS ALL HAVE TO BE THERE SO VINT PUT A LOT OF DATA INTO THIS PRESENTATION BECAUSE WE ALL PRETTY MUCH KNOW IT. WE KNOW THAT THERE'S BEEN A LONG ACCEPTED TRADITION OF RELIANCE ON MALE MODELS AND PART OF THIS IS BECAUSE THERE'S NO ESTRISK ASSESSMENTS CYCLE IN THE MALES THAT RESEARCHERS ARE UNAWARE OF THE SEX DIFFERENCES THAT DUE TO NONREPRODUCTIVE FACTORS, OUR CUE EARLIER WHO HAD TO DO THE HAND TO HAND COMBAT TO GET A STUDY DONE IN THE MALE BECAUSE THERE WERE NO SEX DIFFERENCES THAT COULD BE APPRECIATED IN YUNG ANIMAL SYSTEM A GOOD EXAMPLE OF THAT. REVIEWERS ARE NOT LOOKING FOR SEX DEFICIENCYS. REVIEWERS MALE, AND FEMALE ALIKE HAVEN'T DECIDED THIS IS THEIR ISSUE AND THAT'S PERPETUATED IN INERTIA, AND DESPITE THE CALL FOR ACTION OVER YEAR AND YEAR AND YEARS, THERE HASN'T BEEN THAT MUCH RESPONSE UNTIL NOW. AND NOW IS THAT FULCRUM IN TIME BETWEEN WHICH WE THINK THERE WAS THE DARK AGES OF SCIENCE AND NOW THE BRIGHT AND GREENING DAYS OF THE FUTURE. SO THE BARRIERS FOR EXIST O. SO WE HAVE THIS STATEMENT FROM NIH BUT THERE'S DEBATE, SO WE HAVE AN RFI THAT'S OUT TO REQUEST INFORMATION FROM THE PUBLIC AND BASED ON WHAT WE'VE SEEN ON BLOG POSTS OR IF YOU LOOK AT SCIENTIFIC AMERICAN OR ANY OF THE MAJOR BLOGS THAT ARE TALKING ABOUT THIS, THE COST COMES UP AND I WILL MAKE IT A DEBATABLE POINT AND I WILL WALK OUT OF HERE SO WE CAN PUT THAT ISSUE TO REST. THE BARRIERS INCLUDE THIS THING CALLED THE FEMALE HORMONE EIS STRICE CYCLE AND COMPLEXITY AND I WOULD ARGUE THAT THE MALE DIURNAL CYCLE IS JUST AS PESKY, I DON'T WANT TO MAKE IT A BECKY CYCLE, I WANT TO REDUCE THE RELIANCEOT WORRY OF THE ESTRIES CYCLE AS A PROBLEM. THERE'S BEEN AN INSTITUTIONAL IRB GUIDANCE ON SEX INCLUSION. THERE THIS IS ANOTHER PLACE OR INTERSECTION WHERE WE CAN BEGIN TO GET THE SEX DIALOGUE AS PART OF THE CONVERSATION I'LL SAY FOR THE RECORD, I SAY SEX ALL THE TIME I NEVER SAY GENDER UNLESS IT'S REALLY GENDER. I SAY SEX, I KNOW THERE'S SOME PEOPLE WHO THINK THAT SEX MEANS HAVING SEX, BUT THE MORE WE SAY SEX IN THE CONTEXT OF WHAT IT IS, THE BETTER OFF WE ARE. A GENNINE WHEN YOU HAD YOUR GREW WITH JUDY WOO DROW FF SAYING GENDER AND SHE SAID WHAT'S THE GENDER ISSUE AND I GOT WHY YOU SAID THAT BECAUSE WE NEEDED TO IN THAT CONTEXT THAT'S WHAT NEEDED TO HAPPEN, SO GOING FORWARD WE WANT TO JUST ALWAYS SAY SEX, THAT WOULD BE MY BIAS IN ALL OF THIS AND THAT'S WHEN I'M GOING TO GO AHEAD AND SAY. THERE'S BEEN A TRADITIONAL OVERRELIANCE OF MALE CELLS AND MALE ANIMALS AND CELLS AS ACCURATE SO THERE'S BEEN HISTORICAL PRECEDENT SO UNLESS YOU GET THE SAME GROWTH CURVE OR RESPONSE THAT IT'S NOT A VALID ASSAY. NOBODY BUYIN FROM STAKEHOLDERS, LACK OF KNOWLEDGE ABOUT THE MAGNITUDE OF ESEXER FECS THERE MAY BE JUST THESE MINER THINGS ALONG THE EDGES, YOU KNOW THIS MINER EFFICACY PK DIFFERENCE THAT BECAME AMBIENN, SO THOSE ARE ISSUES AND PUSHERS NEGLECT IS ONE OF THE OTHER ISSUES. SO WE THINK THERE HERE'S ONE PIECE OF DATA BECAUSE IT'S PUBLISHED THIS LAST MONTH OR LAST MONTHS. WE THINK WE'VE HAD SOME KIND OF AN INFLUENCE OF THIS, SO THIS IS ON THE CLINICAL SIDE OF SEX DISPARITY AND PHYSICAL RESEARCH AND LOOKING AT MANUSCRIPTS WITH MALE ONLY OR BOTH SEXES IN 91, 65% WERE MALE ONLY, 2002, 72% AND BY 2011 DESPITE ALL WE SAID IT WAS 85%. SO THAT REPRESENTS A WIDENING OF THE GAPS, NOT A NARROWING OF GAPS OVER TIME SO WE HAVE TO CONTINUE TO WORK HARD TO MAKE SURE THAT WE INCLUDE FEMALES. AND I THINK THE OTHER ADVOCACY PART OF OUR TOOL KIT IS THAT WE HAVE TO SAY THERE ARE REAL CONSEQUENCES IN NOT INCLUDING FEMALES. SO WE MIGHT BE OBSCURING SEX DIFFERENCES WHICH WE KNOW WE CAN DO QUITE EASILY. THERE HAS BEEN ADVERSE EVENTS FROM WOMEN AND DRUGS AND DEVICES, THERE ARE MISSED OPPORTUNITIES AND UNDERSTANDING BASIC BIOLOGY AND THAT'S ONE OF THE MARCHING ORDERS, I THINK WE HAVE AS WE GO BACK TO THE UNIVERSITIES IS THAT CARRY BACK THIS IDEA THAT YOU CAN ACTUALLY LEARN SOMETHING BY STUDYING SEX DIFFERENCES AND YOU COULD DISCOVER NEW BIOLOGY, YOU COULDN'T OTHERWISE, YOU COULD REVEAL AN UNDERLYING SIGNALING MECHANISM BY LOOKING AT SEX DIFFERENCES IN SOME CASES. SO THESE ARE REALLY IMPORTANT HOPEFUL MESSAGES TO THE BASIC SCIENTIST THAT IF YOU LOOK AT BOTH SEXES, YOU ARE GOING TO LEARN SOMETHAT YOU COULDN'T HAVE LEARNED PERHAPS OTHERWISE, AND YOU MAY ALSO LEARN THAT THE--THAT THERE IS NO SEX DIFFERENCE AND THAT'S JUST AS IMPORTANT TO REPORT BECAUSE WE NEED TO KNOW THAT AS WE MOVE DOWN THE SCIENCE PATHWAY. WE HEARD AT THE LAST MEETING OF THIS GROUP TAKEN--THEY THERE IS A REAL AND ALARMING RISE IN U.S. FEMALE MORTALITY IN THESE COUNTIES ACROSS THE STATES SO THE POORER LIVES, THE SHORTER, PR HEALTH, SHORTER LIFE, IOM REPORT WAS QUITE PRESSING IN TELLING US WHERE WE'RE GOING OVER TIME AND WE HAVE TO APPRECIATE THAT THE POOR HEALTH WAS ALL OF US BUT THE SHORTER LIFE WAS THE WOMEN AND THAT IS A CLARRIAN CALL TO ACTION FOR ALL OF US. AND LET'S SEE, WHAT ELSE? THE IRREPRODUCIBILITY OF INICAL RESULTS AND THIS IS WHERE FRANCIS COLLINS I HEARD HIM SAY THIS MORN TAG THIS MAY UNDERLINE THE PROBLEMS AS WE MOVE FROM THE BENCH INTO PHARMA, AND I THINK THAT'S AN IMPORTANT POINT AND AS WE LOOK AT PHARMA AND PHARMA SAYING WE'RE IRREPRODUCIBLE, OF COURSE PHARMA DOESN'T TELL US HOW THEY REPRODUCE OUR RESULTS. SO THERE IS AN INHERENT, THERE'S AN UNDERLYING MYSTERY TO HOW THEY'VE CREATED SOME OF THOSE PIE CHARTS AND THERE ALSO IS A REAL CONFLICT OF INTEREST IN THEIR REPORTING THEY CAN'T REPRODUCE THE RESULTS OF NIH BECAUSE OF THE LICENSING AGREEMENTS. SO WITH THOSE TWO CAVEATS WE KNOW THERE'S PRODUCIBILITY AND SOME BASIC SCIENCE AND I WILL ARGUE IT'S FAR LESS THAN WHAT FARM IS TELLING US IT IS, BUT I DO BY THE ARGUMENT THAT SOME OF THE DIFFERENCES MAY BE BECAUSE PEOPLE HOUSE ANIMALS DIFFERENTLY. THEY SHIP ANIMALS DIFFERENTLY. THESE ENVIRONMENTAL EFFECTS CAN HAVE REAL EFFECT ON THE BIOLOGICAL OUTCOME AND I BELIEVE THAT NOT KNOWING HOW MANY MALES OR FEMALES ARE IN THE ANIMAL STUDIES CAN HAVE A REAL EFFECT AS WELL. SO THERE ARE BENEFITS OF INCLUDING XX, AND XY EARLY, WE WILL INCREASE OUR KNOWLEDGE ABOUT SEX-SKEWED DEVELOPMENT AND TRANSLATIONS AND I LOVE GENNINE'S CASE FOR WHAT'S BEEN MISSING THIS ENTIRE TIME AND HOW THE DROPLETS MOVE INTO THE NEXT IS AN IMAGE THEY WILL USE. I THINK THE BENEFIT INCLUDES TELL BE MORE RIGOROUS IN OUR SCIENCE AND I THINK IF WE COULD JUST TALK, SIT DOWN AND TALK WITH EVERY BASIC SCIENTIST, FORGET THE COST ISSUE FOR A SECOND, I WILL COME BACK TO THAT AGAIN BUT IF WE CAN SIT DOWN AND SAY DO YOU WANT TO DO THE BEST SCIENCE, DO YOU WANT TO BE THE MOST RIGOROUS SCIENT. FUL THEY WOULD SAY YES, WOULD YOU EVER REPORT IN A PAPER THAT NOT HAVING THE TEMPERATURE FOR THE INCUBATOR, THE PERCENT OXYGEN, THE DOSE OF THE DRUG WHICH YOU EVER CONSIDER NOT REPORTING YOUR PAPER. OF COURSE NOT. SEX IS EXACTLY LIKE TIME, TEMPERATURE AND DOSE AND YOUR RIGOR WILL BE FAR BETTER IF YOU REPORT THAT. IT'S THE FIRST STEP TOWARDS PERSONALIZED MEDICINE. THIS IS IS THE ARGUMENTS THAT WE WILL MAKE AND THAT'S WHERE WE'RE GOING AND TO GET TO PERSONALIZED MEDICINE WE HAVE TO CUT THE POPULATION IN HALF. THAT'S THE BOTTOM HALF. AND THEN REPORTING ON SEX REFERENCE IS INAPPROPRIATE GENERALIZATION HELPS WITH THE META-ANALYSIS AND I THINK THE ISSUES OF METAATHAT WILL SIS WHEN YOU DON'T BREAK APART THE DATA BY SEX BECAUSE THE DATA THEMSELVES DO NOT BREAK APART THE ISSUE BY SEX, EXACERBATES PROBLEMS AND MAKES ANNOUNCEMENTS VERY HARD TO INTERPRET OR IN FACT UTILIZE. SO WHAT ARE THE STEPS WE'RE GOING TO NEED TO TAKE. WELL WE WILL NEED TO REQUIRE ALL OF US TO REPORT THE SEX OF SUBJECTS BY SEX. THE SUBJECTS AND OUTCOMES BY SEX. WE NEED TO TRAIN RESEARCHERS HOW TO DO THIS, NOW AT SOME LEVEL THIS IS IMPLICITLY OBVIOUS, THEY SHOULD BE ABLE TO DO IT BUT BECAUSE OF THE BARRIERS THAT ARE SET UP OVER INERTIA AND T, WE WILL PROVIDE MODULES AND GENNINE'S MODULE SHE PUT TOGETHER IS ONE OF THOSE. AND THAT'S A PLACE WHERE WE CAN HAVE TO START GETTING OUR RESEARCHERS TO GO AS ALL OF US WITHIN THE COMMUNITY BUILD THE TOOL KIT OUT OF THE METHODS AND WAYS, THE STATISTICS, OPERATIONAL WAYS TO MANAGE AND HUSBAND THESE DIFFERENT ANIMALS, THAT'S A GREAT PORTAL FOR ALL OF US TO USE, TO AGGREGATE ALL THESE NEW TOOL KITS AND I THINK THAT'S GOING TO BE AN IMPORTANT ASPECT OUT OF THE ROLE OF THE STAINING OF THIS IN ORDER FOR THEM TO UNDERSTAND SEX AND INCLUSION DESIGN, I HAVE TO ASK MEREDITH ABOUT THAT, IT'S ALMOST LIKE A POST MARKETING SURVEILLANCE WE DO FOR THE FDA, WE DON'T DO THAT FOR THE SCIENCES TO KIND OF DO A BIOPSY OF THE PAPERS THAT APPEAR AND AND THREE AND FOUR YEARS AFTER A GRANT MIGHT CLOSE TO SEE WHAT'S BEING REPORT INDEED THOSE PAPERS BECAUSE THERE'S A GAP. BECAUSE THE NIH IS REPORTING FROM THE DATA WE GIVE THEM THAT THERE'S NOT A GAP. BUT WE KNOW THERE IS A GAP BECAUSE OF WHAT'S ENDS UP IN PAPERS. NOW THERE'S A THIRD REASON FOR THAT THAT I DIDN'T MENTION EARLIER AND THAT IS THAT SOMETIMES NEGATIVE DATA NEVER SEES THE LIGHT OF DAY. SO LET'S SAY HAVE YOU A STUDY WHERE THE MALES RESPOND TO EYE NITRIC OXIDE INHIBITOR AND THE FEMALES DO NOT SO YOU COULD JUST REPORTOT MALES BECAUSE THAT'S WHERE THE POSITIVE DATA IS AND THE NEGATIVE DATA NEVER SEES THE LIGHT OF DAY. WELL THAT BECOMES A HUGE PROBLEM BECAUSE THAT NITRIC OXIDE INHIBITOR IS APPROVED AND USE INDEED THE DISEASE ALREADY. THIS IS THE STORY OF MY GOOD FRIEND MOLINA KIDDIE AND SHE ENDED UP REPORTING THIS BUT SHE WAS STUDYING MALE AS THE TIME BUT THAT MEANS THAT THAT DATA MIGHT HAVE BEEN FOUND EARLIER BUT NOBODY REPORTED IT. SO WE'RE GOING TO HAVE TO FIND WAYS TO BE ABLE TO REPORT DATA THAT IS--THAT IS THE NULL HYPOTHESIS, NOT NEGATIVE DATA BUT THE NULL HYPOTHESIS. WE HAVE TO DEVELOP FAQs FOR DESIGN. THESE FAQs ARE THICKS I'VE BEEN DEVELOPING IN A STANFORD WORKSHOP IN THE WEEKEND WAS ADOPTED IS THE METHOD FOR WRITING A PAPER THAT WOULD ALLOW PEOPLE TO UNDERSTAND WHAT'S YOUR BIG QUESTION AND HOW CAN WE ANSWER IT EFFECTIVELY SO YOU UNDERSTAND WHAT YOU'RE GOING TO NEED TO DO. EDUCATE THE JOURNAL EDITORS AND INCREASE AWARENESS TO CONSUMERS, RESEARCHERS AND PHYSICIANS ARE NOW ASKED BY THE PATIENTS, WAS THIS DRUG TESTED IN THE SEX APPROPRIATE WAY, MAYBE THEY'RE GOING TO START ASKING MORE QUESTIONS AS WELL. AND THEN I THINK WE HAVE TO ADD SEX INCLUSION MODULES IN MEDICAL SCHOOL CURRICULUM AS WELL. SO WHAT'S THE RIGHT GUIDANCE TO NIH AND OUR FELLOW INVESTIGATORS, I THINK SOME OF THIS IS RELATIVELY REDUNDANT NOW BUT THE ABSENCE OF SEX HAS CHANGED, THE RELIANCE ON SINGLE SEX MUST OFFER CHANGE SO WE HAVE TO ASSUME BOTH OF THOSE, SO WE LIMIT OUR TEX INCLUSION IS NOT IN THE BEST--SEX INCLUSION IS NOT IN THE BEST INTEREST. NOW COMPANIES WHEN THEY REPORT THIS IRPRODUCIBILITY OF THE BASIC DATA THAT COMES OUT OF NIH, IT IS ALSO THE CASE THAT WHEN WE AS BASIC SCIENTISTS ARGUE IT MAY BE MORE COSTLY THAT WE'RE SHARP INSTRENESICALLY BIASED AS WELL BECAUSE OUR CAREERS DEPEND ON THESE FUNDS SO WE HAVE TO MAKE SURE WE'RE UNDERSTANDING THAT THE COSTS ARE BORN BY A TAXPAYER IN WHOSE BEST INTEREST THIS WORK IS BEING DONE IT'S NOT IN THE BEST INTEREST OF OUR PAPER OR OUR NEXT GRANTS AND THAT'S A HARD THING TO UNWIND AND UNPACK BUT THAT IS IN, AND ENOUGH STUDIES AND ANOTHER COST MAY BE A LITTLE SLOW E, I WOULD ARGUE IT'S--WHAT WE MIGHT NEED. SO TOOLS, SHE IS THEY DISCERNED SEX BASES AND HAS A PAPER IN THE JOURNAL OF AND IT'S THESE KINDS OF DECISION TREAT FIST YOU WILL THAT'S GOING TO ALLOW OUR COLLEAGUES TO UNDERSTAND HOW TO DO FUNDAMENTAL BASIC SCIENCE EITHER IN THE NTACs OR THE GONADECTAMYSELF CASE, AND WE ALSO HAVE GENOTYPE MOUSE MODEL THAT ALLOWS YOU TO LOOK AT THE GONAD AND LOOK AT THE SEX HORMONES VERSES THE SEX CHROMOSOMES THEMSELVES AND WHEN YOU DO THIS, CAN YOU SEE AND THIS IS DATA THAT SABRA KLEIN GAVE ME FROM JOHNS HOPKINS THAT THE SEX CHROMOSOME CAN ENHANCE THE OUTCOME OF THE INFECTIOUS DISEASES BUT NOT ALL VIRUSES HAVE THE SAME EFFECT, SO IN THESE ANIMAL MODELS THAT HAVE THE PRESENCE OR ABSENCE OF SRY GENE TO MAX LINE ICE THAT THE COXSACKIE VIRUS, VERSES THE INFLUENZA VIRUS AND HE'S AND HER COLLEAGUES ARE WORKING ON AND MAY PROVIDE SOME VALUE TO SOME PARTS OF OUR COMMUNITY. WE NEED TO MAKE THAT NUMBER AVAILABLE TO A LARGE NUMBER OF RESEARCHER FIST THIS IS THE DIRECTION THEY WAT TO TAKE. I REALIZED THIS IS NOT THE SLIDE I WANTED TO LOAD, BUT THIS IS NOT THE PINNEDDER GHAST GRAPH, BUT THIS IS WOB THAT WAS PUBLISHED EARLIER THIS YEAR IN PAPER WHERE THEY DID A INETTA ANALYSIS OF ALL THE BEHAVIORS AND OUTCOMES OF MALES AND FEMALES TO DETERMINE IF THE ESTRICE CYCLE HAD AN IMPACT, AND THEY FOUND THAT IT DID NOT HAVE A MAJOR IMPACT ON THESE OUTCOMES SO WHAT THAT MEAN SYSTEM THAT YOU DON'T HAVE TO GO IN AND DO THE FIRST STUDY, LOOKING AT THE ESTRISK ASSESSMENTS CYCLE. YOU CAN USE RAPPED ORDER OF MICRONS CYCLING ANIMALS AND IF YOU DO FIND A SEX DIFFERENCE, CAN YOU DRILL DOWN AND FIND OUT IF THERE'S A HORMONAL COMPONENT TO THAT PARTICULAR EFFECT. AND I'LL MODIFY THAT SIDE AND GIVE YOU AN UPDATED DOCUMENT SO EVERYONE HAS THE GLED SLIDE. I'M PROUD TO SAY THAT AS SOON AS THE ARTICLE CAME OUT, I SENT TO THE VICE PRESIDENT OF RESEARCH AND THE DIRECTOR OF OUR CORES AT WESTERNER AND PHIL HOFPMAN SAID NOW ALL OR CORES WILL HAVE SEX INCLUSION POLICY AND SO THEN WAS SENT OUT AN E-MAIL TO MAKE IT SO. AND THIS IS FROM VICE PRESIDENT BUYER RESEARCH AND THE HIGHEST LEVEL OF OUR INSTITUTIONS IS GOING TO MAKE A DIFFERENCE IN ORDER FOR US TO ENABLE THIS WORK. SO FOR EXAMPLE, THE SKIN DISEASE CORE AT NORTHWESTERN, IN FACT ALL THE DISEASE, THE SKIN AND CORFACILITIES AROUND THE UNITED STATES HAVE ONLY USED MALE FORESKIN AS THEIR SOURCE OF SKIN AND AMY POWER WHO DIRECTS OUR CORE JUMPED STRAIGHT UP IN THE AIR, AND REALIZED THAT FOR HER CAREER AND HER ENTIRE FIELD IT'S ALL MALE SO SHE'S THE FIRST CORE TO BEGIN TO TO DOCUMENT THE PHYSIOLOGY AND TO TAKE FEMALE SKIN AND PUT IT INTO THEIR CORE TO DISTRIBUTE IT AROUND TO ALL THE RESEARCHERS SO I THINK EACH OF OUR EN--STRATEGIES TUITIOS IN THAT CONVERSATION HAPPENED EARLIER TODAY, WHAT ROLE DID THE INSTITUTION HAVE IN ENABLING THE WORK THAT WE HEARD EARLIER. I THINK THE INSTITUTION HAS AN INCREDIBLY IMPORTANT ROLE TO PLAY IN ORDER TO ENABLE THIS KIND OF WORK TO GO FORWARD. THE RESEARCH TOOL BOX ALSO INCLUDES GETTING OUT THE WORD WHERE MATTERS, SO IT TURNS OUT STEPHEN IS AN ALUMNI OF NORTHWESTERN WHICH IS TERRIFIC AND MANY OF YOU SAW THAT HE PICKED UP ON THE LESLIE STALL 60 MINUTES REPORT AND MY FRIEND I TALKED ABOUT EARLIER WHO IS ALSO AT NORTHWESTERN AS ONE OF THE FOLKS THAT HE FOCUSED ON AND YOU KNOW THAT, I THINK DOES A LOT FOR WHAT WE HAVE BEEN INTERESTED IN. WE GOT CONGRESS INTERESTED, WE GOT JOURNALISTS, INTERESTED. AND WE GOT THE KIND OF PUBLIC MEDIA, WHAT WAS CO BEAR THE COMEDY CENTRAL INTERESTED AND THIS REALLY MATTERS, I THINK TO WHERE WE ARE TODAY. SO THIS IS ANOTHER WEB SITE. THIS IS FROM CANADA FROM THE WOMEN'S HEALTH COLLABORATIVE. THEY HAVE A GREAT SET OF TOOLS THROUGH GENDER LENS AND THEY HAVE A SERIES OF ANALYSIS FOR--CALLED THE GENDER AWAKENING TOOL WHICH ALLOWS TO YOU DO SCIENCE AND THE PAPER AND STEP ONE S&P THERE A SEX ISSUE RELEVANT FOR SUBJECT RESEARCH, LITERATURE RESEARCH, FIND A GUIDING QUESTION OR HYPOTHESIS, THESE ARE THINGS WE NEED TO TEACH OUR OPPORTUNITIES AND WE NEED TO TERM THEM THAT DESCRIBE SEX, AND INTERPRETATION AND REPORT, LOTS TO SEE IF YOU'RE OVER GENERALIZING IF YOU ARE LOOKING AT SEX EFFECT OR NOT. NOT EVERYTHING HAS A SEX EFFECT AND SO WE HAVE TO BE REALLY CLEAR ABOUT THAT. AND THEN JOURNAL POLICIES AND I THINK I'M PROUD OF THE ENDOCRINE SOCIETY IN PARTICULAR FOR THEIR WORK TO INSTRUCT ALL AUTHORS THAT YOU HAVE TO INCLUDE THE SEX IN THE TITLE, IN THE ABSTRACT AND IN THE TERLS AND METHODS AND I THINK THAT KIND OF ATTENTION TO THIS ISSUE IS WHAT ALL OF OUR JOURNAL AUTHORS, EDITORS NEED TO DO AND THERE WILL BE ANNOUNCEMENTS FROM SCIENCE AND NATURE, IN NOVEMBER ABOUT THIS INCLUSION OF THAT POLICY, SO THAT'S VERY EXCITING AND I THINK WE'RE UP TO ABOUT 22 OR 23 JOURNALS WHO HAVE THIS POLICY AND MOLINA KIDDIE BASED ON THE SERNLGICAL REVIEW SHOWED YOU ON THE SIDE EARLIER HAS FIVE EDITORS FROM FIVE JOURNAL WHO IS WILL NOW INCLUDE THIS POLICY INCLUDING THE ENTIRE JAMA FAMILY SO THESE ARE CRITICAL, TANGIBLE ACTIVITIES THAT NEED TO HAPPEN TO KIND OF BE PART OF THE CARROT AND THE STICK TO ALLOW THIS WORK TO GO FORWARD. STANFORD HAS A TREMENDOUS SITEOT SCIENCE, HEALTH AND MEDICINE, THEY HAVE GREAT TERM DEFINITIONS, THEY HAVE A LOT OF CASE STUDIES, ON SEX AND GENDER ISSUES. THEY HAVE A SERIES OF CHECK LISTS THAT ALLOW YOU TO UNDERSND FROM YOUR KIND OF SCIENCE WHAT MIGHT BE THE ISSUES THAT YOU HAVE TO ASSESS. SO I THINK JUST--THIS IS MY LAST SLIDE, I MADE THIS JUST FOR JEANINE SO THIS IS MY LAST SLIDE BUT TO SUMMARIZE WE HAVE TO REQUIRE RESEARCH TO REPORT THE SEX AND THE OUTCOME BY SEX EVEN IF IT'S THE NULL HYPOTHESIS. WE HAVE TO TRAIN RESEARCHERS AND EXPERIMENTAL DESIGN, EDUCATE REVIEWERS, WE HAVE TO MONITOR, MAKE SURE THAT RESEARCH CENTER CORES ARE INCLUDED IN THE EQUATION, DEVELOP FAQs FOR STAKEHOLDERS, EDUCATE JOURNAL EDITORS, EDUCATE SCHOOL CURRICULUM AND ENCOURAGE PROFESSIONAL SOCIETIES AND INCREASE AWARENESSOT IMPORTANCE OF SEX TO THE CONSUMER AND I THINK THE CONSUMER PLAYS A REALLY VITAL ROLE IN ALL OF THIS. SO START WITH THE PILOT PROJECT POT SIS AND I HOPE THIS TURNS OUT TO BE TRUE, THAT IF THIS IS MIDPARAGRAPH IN THIS CONVERSATION THAT MAYBE STARTED SEVERAL YEARS AGO IN THIS SETTING, THAT IN A COUPLE OF YEARS FROM NOW, WILL BE MOVING ON TO TO THE NEXT HYPOTHESIS AND WITH THAT I THANK YOU VERY MUCH AND JEANINE I LIKE YOUR QUOTE FROM HELEN KELLER, BUT I HAD A MATCHED ONE. SO SEX INCLUSION. >> WE WILL HAVE DISCUSSION TIME, IS THERE A QUESTION FOR DR. WOODRUFP? OKAY, GREAT, THANK YOU VERY MUCH. WE'RE GOING TO GO STRAIGHT INTO OUR COMMUNINS AND LEGISLATION UPDATES AND MISS ANN RANCOURT AND JULIANA BLOME WILL GIVE THOSE UPDATES FOR YOU. DR. DEULANCY ARE YOU STILL ON THE PHONE? >> I AM. >> WE WILL FOLLOW THE AGENDA THERE. >> GREAT. >> HI, EVERYONE I'M ANNE RANCOURT, I'M WITH THE OFFICE OF RESEARCH ON WOMEN'S HEALTH. I WILL TALK ABOUT COMMUNICATIONS IN OUR OFFICE OVER THE PAST FEW MONTHS PARTICULARLY AROUND THIS PARADIGM SHIFT OF INCLUDING BOTH SEXES IN PRECLINICAL RESEARCH CAN WE'RE CALLING STUDYING SEX TO STRENGTHEN SCIENCE. THE NATURE COMMENT WAS RELEASE OFFICE OF DIVERSITY MAY 14th AND WITH THIS RELEASE WE BEGAN A TWO PRONGED COMMUNICATION STRATEGY, IN THE RESEARCH NEED TO STUDY BOTH SEXES, AND VERY IMPORTANTLY TO ENGAGE IN DIALOGUE WITH SCIENTISTS, STAKEHOLDERS AND THE PUBLIC ON THIS ISSUE AND I THINK BOTH OF THOSE HAVE BEEN TOUCH OFFICE OF DIVERSITY IN PREVIOUS CONVERSATIONS TODAY BUT I WANT TO UNDERSCORE THAT BOTH OF THOSE HAVE BEEN VERY CRITICAL TO US AS WE ROLL THIS OUT. SO WHEN WE--RELEASE THE NATURE COMMENT, WE ANTICIPATED THAT THERE WOULD BE A LOT OF COVERAGE. WOMEN'S HEALTH IS A TOP ISSUE FOR BOTH POLICY AND HEALTH REPORTERS IN THE MEDIA AND COMMENT PUT FORTH A PROACTIVE APPROACH TO ADDRESSING A LONG STANDING GAP. AND BOTH OF THOSE ARE SALIENT TO THE MEDIA WE THOUGHT THERE WOULD BE INTEREST AND IN FACT WE WERE RIGHT AND THE EDITORS OF THE NEW YORK SOMETIMES AGREED AND RAN THIS ON THE FRONT PAGE THE NEXT DAY. AND IN FACT A LOT OF EDITORS AGREED THIS WAS NEWS AND WE HAD OVER 100 STORIES APPEAR IN THE MEDIA IN MAY WHEN THIS WAS RELEASED MAKING THIS THE LARGEST NIH DRIVEN STORY OF THE YEAR. AND WHAT I REALLY LIKE ABOUT THIS SLIDE--[ APPLAUSE ] --SURE. >> SO I GUESS I WILL LIKE TO MAKE A MOTION I DON'T KNOW WHAT IT IS YET. [LAUGHTER] BUT I WOULD LIKE TO MAKE A MOTION AS FOR THE MINUTES COMMENDING DR. AND HER TEAM FOR THIS ACHIEVEMENT. >> ALL RIGHT. >> ALL IN FAVOR? >> ALL THOSE IN FAVOR? >> ALL THOSE AGAINST? >> ANY ABSTAINERS? >> ALL RIGHT. MOTION CARRIED. >> [ APPLAUSE ] >> NOTED FOR THE MINUTES. THANK YOU. >> AND SO WHAT I REALLY LIKE ABOUT THIS SLIDE IS JUST THE INCREDIBLE VARIETY OF OUTLETSA COVERED THIS STORY. YOU DON'T SEE VERY MANY NEWS STORIES THAT RUN IN SCIENCE AT THE SAME TIME AS THEY RUN IN GLAMOUR MAGAZINE. BUT THIS STORY HAS BROUGHT APPEAL. IT'S INTERESTING TO EVERYONE. IT'S SOMETHING EVERYONE UNDERSTANDS, AND EVERYONE ASKS, WHY, WHY, WHY ARE WOMAN NOT INCLUDED? I THOUGHT THEY WERE SO.Y IT'S A TOPIC THAT OBVIOUSLY CONTINUES TO BE OF INTEREST TO FOLKS AND PEOPLE ARE REALLY ANTICIPATING WHAT WE'LL DO NEXT AND WANT TO FOLLOW THIS STORY. >> WE ALSO HAD A NUMBER OF OPINION PIECES. THIS IS AN EDITORIAL THAT THE NEW YORK TIMES PUBLISHED IN THE WEEK AFTER THE NATURE COMMENT CAME OUT AND OVERWHELMINGLY OPINION PIECES ON THIS TOPIC WERE PUN LICK AND EMBRACED THIS CHANGE AND IT'S IMPORTANT TO NOTE THAT A NUMBER OF THESE FROM THE SCIENTIFIC COMMUNITY TALKED ABOUT THE NEED TO PAY ATTENTION TO THE DETAIL OF THE POLICY THAT WILL BE RELEASD AND THAT THE DEVELOPMENTAL ENDOCRINOLOGY SILL IN THE DETAILS THERE AND THOSE ARE CONSIDERATIONS WE TOOK VERY SERIOUSLY AND OBVIOUSLY ARE HOPING TO GET MORE OF THAT INPUT WITH THE REQUEST FOR INFORMATION THAT WAS RELEASED LAST WEEK. WE ALSO HAD GLOBAL COVERAGE. THIS WASN'T JUST AN AMERICAN STORY, WE DID INTERVIEWS IN CANADA AND AUSTRIA, LE MONITORED, INTERNATIONAL HERALD TRIBUNE AND ALJAZERRA, AND AS WAS MENTIONED, YOU KNOW A STORY MATTERS WHEN IT'S ON LATE NIGHT TV SO CAN YOU SEE STEPHEN COLBERT'S TAKE ON THE ISSUE THERE. WE ARE ALSO HAPPEN JOINED BY ORGANIZATION FOR YEARS IN TALKING ABOUT THIS TOPIC, HERE DR. CLAYTON AND JOINED BY THE FILIB GREEN BERGER ON PBS NEWS HOUR AND WE ARE ALSO THRILLED THAT RESEARCHERS IN THIS SPACE FOR YEARS WERE ABLE TO JOIN THE CONVERSATION AND EXPAND THE DISCUSSION AND ADD NEW POINTS TO CONSIDER WHICH IS PART OF THIS OVERALL THEME OF CREATING AN IMPORTANT AND THOUGHTFUL CONVERSATION AROUND THIS ISSUE TO MAKE SURE IT'S IMPLEMENTED IN THE BEST WAY POSSIBLE. AND SO, JUST YESTERDAY, WE ANNOUNCED OVER 10 MILLION DOLLARS IN SUPPLEMENTAL FUNDING FOR GRANTEES TO TAKE SEX INTO ACCOUNT WHICH PRESENTED ANOTHER OPPORTUNITY TO EXPAND THIS DISCUSSION AND THE PUBLIC SPACE. AND NOW TO KIND OF TAKE THIS DEBATE FURTHER AND TALK ABOUT THE TYPE OF STUDIES THAT WE'LL NOW TAKE SEX INTO ACCOUNT, WHY THIS IS IMPORTANT, WHAT THEY CAN DISCOVER AND WHAT THEY CAN ACHIEVE, THIS ANNOUNCEMENT LED US POINT TO SOME OF THE NEWLY FUNDED RESEARCH AS AN EXAMPLE THAT THIS IS WHAT YOU CAN, THIS WHAT WILL'LL WE'LL BE STUDYING, THIS IS WHAT WE CAN FIND OUT BY MAKING THIS INVESTMENT, BY MAKE THANKSGIVING IMPORTANT. AND TO LOOK AT WHAT THIS RESEARCH WILL LOOK LIKE WHEN IT INCLUDES BOTH SEXES. THE POTENTIAL THERE AND LETS PEOPLE IMAGINE WHAT'S POSSIBLE WHICH IS VERY POWERFUL. AND SO WE AS DR. CLAYTON MENTIONED WE CREATED A WEB SITE WHERE YOU CAN GO TO STAY UP TO DATEOT LATEST WHEN IT COMES TO STUDYING SEX TO STRENGTHEN SCIENCE. GO THERE AND YOU CAN FIND THE LATEST NEWS AND QUESTIONS AND ANSWERS ON THE UPCOMING POLICY. LINKS TO THE REQUEST FOR INFORMATION, IF YOU'RE INTERESTED IN THAT. STORIES FROM RESEARCHERS, EXAMPLES OF FUNDED RESEARCH, DR. COLLINS EARLIER TODAY MENTIONED THE EXAMPLES THAT WERE USED IN THE NATURE COMMENT. WE ACTUALLY HAVE A READING ROOM ON THIS WEB SITE WHERE CAN YOU GO AND FIND THE SEMINAL JOURNAL ACLES THAT WE RECOMMEND YOU TAKE A LOOK AT AS YOU CONSIDER THIS ISSUE AND MORE. AND SO THAT IS--THAT KIND OF ENDS PRE'S SENTATION ON THIS PARTICULAR ISSUE BUT I WOULD LIKE TO TALK A BIT ABOUT SOME OF THE OTHER COMMUNICATIONS ACTIVITIES THAT WE'VE BEEN DOING IN THE OFFICE SINCE WE LAST MET IN THE SPRING. IN TERMS OF WOMEN AND BIOMEDICAL CAREERS WE'VE BEEN WORKING WITH THE WHITE HOUSE ON A FEW COMMUNICATION TACTICS AROUND THEIR OUTREACH ABOUT WORKING FAMILIES IN AMERICA AND THAT CONTINUES TO BE A PRIORITY FOR US, DR. CLAYTON DID A LIVE TWEET OF A WHITE HOUSE EVENT WHICH WAS OUR FIRST FORRAY INTO THAT AND SHE MENTIONED EARLIER WE'VE BEEN ACTIVE ON TWITTER. AND THE DOCTOR HAS A BLOG ONLINE THAT YOU CAN READ THAT KEEPS EVERYONE UP TO DATE ON THE LATEST NEWS FROM ON THIS POLICY AND FROM OUR OFFICE. AND FINALLY I WANT TO MENTION AGAIN THAT WE ARE THRILLED TO BE RELEASING THE WOMEN OF COLOR HEALTH DATA BOOK LATE THERAPY AND YEAR AND WE'LL BE ROLLING OUT A NUMBER OF ACTIVITIES AROUND THAT RELEASE TO MAKE SURE THAT PEOPLE IN THE MEDICAL COMMUNITY AND RESEARCH COMMUNITY ARE AWARE OF THAT PUBLICATION AND THE IMPORTANCE OF THAT DATA TO THEIR WORK. SO THANK YOU. [ APPLAUSE ] >> THANK AND YOU AS DR. BLOME COMES UP, I WILL ACKNOWLEDGE THIS TRULY IS A TEAM EFFORT AND I WANT TO IDENTIFY THE COMMUNICATIONS TEAM, ALLISON, DAVID AND ANNE, RANCOURT AND THE ENTIRE OFFICE OF MAY BE, MANY PEOPLE TO GET UP ALL TO THE PLACE WHERE THIS COULD HAPPEN. SO THANK YOU. THANK YOU ALL AND WE WILL HAVE DR. BLOME GIVE A LEGISLATIVE UPDATE AND THEN WE'LL GO INTO DISCUSSIONS AND START DISCUSSIONS WITH PERSPECTIVES FROM OUTGOING ACRWH MEMBERS, BUT DR. BLOME. >> FIRST OF ALL CAN EVERYBODY IN THE BACK CHEAP SEATS HEAR ME BECAUSE I WAS TOLD I HAVE TO STAND CLOSE TO THE PODIUM, NOT GO TOO FAR BUT I DON'T WANT TO STAND BEHIND IT, THAT'S JUST NOT MY STYLE. SO AS WAS MENTIONED TODAY WE HAD A LOT OF INTEREST THIS TERMS OF COMMUNICATION, REACHING THE PUBLIC AND OUR OFFICE AND WHAT WE'RE INTEREST IN THIS PART OF THIS IS ATTRIBUTABLE TO OUR REP REISN'TATIVES. WE'VE BEEN LUCKY BECAUSE WE HAVE A NUMBER OF MEMBERS THAT ARE INTERESTED IN ISSUES THAT ARE DEAR TO OUR HEART, SO THAT WOULD BE WOMEN IN CLINICAL TRIALS, SEX AS A BIOLOGICAL VARIABLE RESEARCH AND ALSO PARTICIPATION OF--WELL, I SAID WOMEN IN TRIALS,--OH ANIMAL MODELS. THE ANIMAL MODELS. SO I WALK YOU THROUGH A FEW OF BILLS THAT CAME TO CONGRESS AND CAME TO THE FLOOR, SOME GOT ATTENTION AND SOME CAN'T BUT GIVE YOU A FLAVOR OF WHAT WE'VE BEEN SEEING. SO THE FIRST WAS THE LETTER THAT THE DOCTOR MENTIONED THIS WAS FROM REPRESENTATIVE LORA RODRIGUEZ SCHEDELORA RODRIGUEZ O, AND THIS ASKED ABOUT NIH'S USE OF MALE ANIMAL MODELS IN THE RESEARCH AND AS DR. FRANCIS NOTED THIS BROUGHT INTENTION INTERNALLY FOR US TO LOOK AT OUR OWN DATA SETS AND SCIENCE AND SEE WHAT WOO WERE WE FUNDING AND AS HE NOTED WE WERE DISAPPOINTED. WE WERE DISAPPOINT INDEED WHAT WE SAW. DR. COLLINS RELATED HIS COMMITMENT TO ADDRESSING THIS ISSUE AT THE LABOR APPROPRIATIONS HEARING. IT WAS NOTED IN THE HOUSE AND THE SENATE. AND AS YOU SAW HERE TODAY HE'S REITERATED HIS PERSONAL COMMITMENT TO THIS ISSUE IN MOVING FORWARD. AS WE ALL KNOW THE COMMENTARY NATURE CAME IN NEXT WHICH BROUGHT MORE ATTENTION. SO WE'VE ALSO SEEN A FEW OTHER INQUIRIES, WE HAD INQUIRY FROM BOTH THE HOUSE AND THE SENATE. AND FROM--TO GAO TO UPDATE AN OLD REPORT ON WOMEN'S PARTICIPATION IN CLINICAL TRIALS. SO THIS WAS SIGNED ON BY ABOUT 10 DIFFERENT CARPETS AND REPRESENTATIVES. SOME OF THEM POWERFUL AND INFLUENTIAL MEMBERS LIKE REPRESENTATIVE WAX MAN ALONG WITH CENTER Mc CULLS SKI AND SENATOR HARKIN WHO IS RETIRING THIS SESSION. HOWEVER WE KNOW THAT WILL BRING US LOTS OF ATTENTION AND WE ALSO KNOW THAT ALTHOUGH WE HAVEN'T RECEIVED THIS YET, IT'S COMINGMENT GENERALLY WHAT HAPPENS, I DON'T KNOW HOW FAMILIAR YOU ARE BUT CONGRESS WILL SEND A REQUEST TO THE GAO AND SAY WE'RE INTERESTED IN THIS TOP AND I CAN WE WANT TO YOU DO RESEARCH ON IT FOR US AND GET BACK TO US WITH THE REPORT. WHAT HAPPEN SYSTEM THE AGENCIES WHO ARE INVOLVED IN THAT, THEY WAIT TO HEAR FROM THE GAO AND THEN WE GET A CONFERENCE CALL WHERE WE START OFF THE REPORT AND START INQUIRIES. THIS HASN'T HAPPENED YET BUT WE ARE EXPECTING IT TO HAPPEN THIS FALL SO WE'LL KEEP YOU TUNED ON THAT. GAO REPORTS TAKE ANYWHERE FROM THREE MONTHS TO SIX MONTHS SOMETIMES A YEAR DEPENDING ON COMPLEXITY AND THE URGENCY OF THE REQUEST, SO WE'LL KEEP YOU POSTED ON DEVELOPMENTS AS THAT OCCURS. BUT WE ALSO HAD AS THE DOCTOR DISCUSSED WE HAD THE ACTION PLAN WHICH CAME OUT AND LOOKED AT SEX, AGE, RACE AND ETHNICITY. SO THAT WAS A LET THEY'RE WENT TO COMMISSIONER HAMBERG, THEY'VE RELEASED IT, THEY HAVE RECEIVED MINUTES. THEY HAVE A STEERING COMMITTEE THEY'RE MOVING FORWARD. SO THE LAST INQUIRY WE GOT WAS ONE FROM SENATOR STABANAO AND SENATOR SLAUGHTER THAT LOOKS AT THE PARTICIPATION OF WOMEN IN CLINICAL TRIALS AND WANTED TO KNOW WHAT DID WE SEE THERE. WHAT WAS GOING ON AND WHAT ACTUALLY--I'M SORRY LET ME BACK UP. WE LOOKED AT THAT AND ASKED ABOUT WHAT DATA IS ON CLINICALTRIALS.GOV SITE. SO THAL SITE THAT IS MAINTAINED BY NIH'S NATIONAL LIBRARY OF MEDICINE WE HAVE DATA STORED ON ALL THE CLINICAL TRIALS THAT ARE GOING ON IN THE U.S. SO THIS REQUEST IS ASKING ABOUT WHY DON'T WE HAVE MORE DATA THERE? AND WHY DON'T WE UNDERSTAND? AND HOW CAN WE MAKE IT BETTER? AND HOW CAN WE IMPROVE THE GRAPHIC THERE IS? SO THERE'S A MOVE TO LOOK AT THAT. SO NIH IN THE STAGE IS DEVELOPING A NOTICE OF PROPOSED RULE MAKING SO THEY'RE COMING OUT WITH AN OPPORTUNITY FOR THEM TO COMMENT ON RULE PROPOSE AGING AND--PROPOSING TO USE THE SITE AND UNDERSTAND THE CLINICAL TRIALS DATA THERE. AND I'LL ALSO GIVE INCREASED GIDANCE TO RESEARCHERS ABOUT HOW TO COLLECT THE DATA ONCE REQUIRED TO BE SUBMITTED. SO THE LAST IMPORTANT PIECE OF LEGISLATION THAT HAS COME UP WITH REGARD ON ORIGINAL OFFICE IS THE RESEARCH FOR ALL ACT. THIS WAS INTRODUCED BY REPRESENTATIVE COOPER AND REPRESENTATIVE LOOMIS IN JUNE. THIS REQUIRES THE FOUR SECTIONS TWO PERTAINS TO FDA AND TWO PERTAIN TO NIH AND NIH ASKED US TO TO LOOK AT OUR RESEARCH IN TERMS OF ANIMAL CELLS AND TISSUE AND DO A STRATIFIED ANALYSIS ON THAT TO INCLUDE IT AND TO DO ANALYSIS. THIS BILL UNFORTUNATELY IS PROBABLY NOT GOING TO GO ANYWHERE. IT'S BEEN REFERRED TO THE HOUSE SUBCOMMIT O ON HEALTH, BUT WE'RE AT THE END OF THE SESSION, WHICH MEANS TELL DIE IN SESSION AND NEED TO BE INTRODUCE INDEED THE NEXT SESSION IN CONGRESS. SO THAT BRINGS TO ME TO WHAT'S HAPPENING IN CONGRESS. SO WE'RE FINISHING UP THIS SESSION AND RIGHT NOW WE HAVE WE DON'T HAVE A LABOR APPROON BILL. TWO BILLS WERE INTRODUCED IN THE HOUSE SIDE, THERE WAS DISAGREEMENT TO THE SENATES O WE COULDN'T BRING THE BILL TO THE FLOOR FOR A VOTE. SO AT THIS POINT ANY LABOR HHS APPROPRIATIONS AM COME UNDER AN OMNIBUS APPROPRIATE PACKAGE SO WE WILL WAIT AND SEE WHAT HAPPENS WITH THAT. SO LUCKILY FOR US THOUGH, WE DO HAVE MONEY BECAUSE BEFORE CONGRESS LEFT FOR THE MIDTERM ELECTIONS TO START CAMPAIGNING THEY PASSED A CONTINUING RESOLUTION, SO WE--GOVERNMENT IS NOW FUNDED FOR ANOTHER 10 WEEKS UNTIL DECEMBER 11th. IT'S FUNDED AT THE 2014 LEVELS THOUGH, NOT THE 2015 LEVELS SO WE'RE IN A HOLDING PATTERN. IT'S ALSO IMPORTANT TO KNOW THAT ONCE DECEMBER 11th ROLLS AROUND, WE'RE OUT OF MONEY AGAIN SO WE NEED TO HAVE ANOTHER BUDGET AGREEMENT. SO THE QUESTION I GET ASKED MOST OFTEN IS WHAT ARE THE PROSPECTS FOR THAT? WELL, IT DEPENDS. DEPENDS ON HOW THE ELECTIONS GO. SO THE REPUBLICANS ARE SLATED TO PRETTY MUCH RETAIN THEIR MAJORITYOT HOUSE SIDE, THE SENATE SIDE IS EXPECTED TO FLIP WHICH IS TYPICALLY SOMETHING HAVE YOU SOMETHING TO SEE WHEN YOU HAVE INCUMBENT PRECEDENCY AND AT IT'S THE END OF THEIR SESSION. SO IF WE END UP WITH BOTH CHAMBERS BEING REPUBLICAN. THERE'S A COUPLE WAYS IT COULD GO. FIRST THE REPUBLICANS COULD COME IN AND IN DECEMBER THEY WILL RIGHT ANOTHER SHORT-TERM CONTINUING RESOLUTION ALCOHOL BE FUNDING US THROUGH MARCH AND THEN WHEN THE NEW CONGRESS COMES IN, IN MARCH AND THEY HAVE A MAJORITY THEY WOULD THEN REWRITE THIS FISCAL YEAR 2015 BILL TO REFLECT GOP PRIORITIES. OR, THEY COULD COME IN, DO A CONTINUING RESOLUTION FOR THE ENTIRE REST OF THE YEAR AND THEN START WORKING ON THE FY2016 APPROPRIATION BILL SO WE WOULD MAINTAIN A FLAT BUDGET THERE. SO IT'S VERY DIFFICULT TO TELL WHAT'S GOING TO HAPPEN. AS YOU KNOW WE HAVE SEQUESTRATION IN THE PAST WHERE THE GOVERNMENT WORKERS WERE FURLOUGHED AND AS MANY OF YOU MAY HAVE NOTED A LOT OF THE FEMALE CONGRESS PERSONS GOUTS RECOGNIZED FOR THEIR ABILITY TO STEP IN AND HELP SOLVE THE PROBLEMS WITHOUT TOO MUCH EGO BY THE WAY. SO THE MOST I CAN TELL YOU RIGHT NOW IS I WOULD PARAPHRASE BETTY DAVIS, FASTEN YOUR SEAT BELTS IT'S GOING TO BE A BUMPY RIDE. >> THANK YOU DR. BLOME. ANY BRIEF QUESTIONS FOR JULIANA? OR FOR ANNE? THEY'LL BE HERE SO IF THERE'S SPECIFIC QUESTIONS. THANK YOU SO MUCH LET'S GO RIGHT INTO OUR DISCUSSION. ONE OF THE THINGS THEY LIKE TO DO IS WHEN MEMBERS ARE GOING OFF THE ADVISORY COMMITTEE, I LIKE TO ASK THEM TO SHARE THEIR PERSPECTIVES ON THEIR EXPERIENCE, ON THE OFFICE AND THEIR RECOMMENDATIONS FOR THINGS GOING FORWARD AND I KNOW THE DOCTOR HAS TO LEAVE EARLY SO I WILL GIVE YOU THE FIRST WORD ON THAT. >> THANK YOU. I CAN'T BELIEVE HOW FAST THE TIME HAS FLOWN BY, I FEEL LIKE I JUST CAME ON THE COMMITTEE AND YET WHEN I THINK ABOUT ALL THAT HAS BEEN OCOMPLISHED OVER THE PAST FOUR YEARS, THE LIST IS REALLY LONG. SO IT HAS BEEN A GREAT HONOR AND PLEASURE TO SERVE ON THE COMMITTEE TO WORK WITH ALL OF YOU, TO WORK WITH ALL THE WONDERFUL STAFF AT ORWH AND OF COURSE, THE WORK WITH JANINE AND VIVIAN BEFORE HER AND IT'S BEEN AN EXCITING TIME TO BE ON THE COMMITTEE WITH THE NEW LEADERSHIP TEAM AND I DON'T THINK THERE'S ANY QUESTION THAT THE RIGHT PERSON WAS PICKED FOR THE JOB. AND WITH THE NEW STRATEGIC PLAN AND THE TREMENDOUS EXCITEMENT OF THIS PAST YEAR WITH A NEW POLICY. AND I'M JUST SO IMPRESSED BY ALL THAT YOU'VE DONE AND ALL THAT YOU CONTINUE TO DO TO ADVANCE RESEARCH ON WOMEN'S HEALTH AND SEX DIFFERENCES. I WILL CERTAINLY MISS BEINGOT COMMITTEE BUT I WILL CONTINUE TO CHEER YOU ON FROM THE SIDE LINES AND TO SUPPORT YOUR WORK IN ANY WAY THAT I CAN. AND FORTUNATELY, I WILL STILL GET TO WORK WITH YOU THROUGH THE CONGRESS AND IT IS JOURNAL. SO I JUST THANK YOU ONCE AGAIN FOR THIS GREAT OPPORTUNITY AND BEST WISHES TO ALL OF YOU. >> THANK YOU SUSAN, THANK YOU FOR THE KIND WORDS WE APPRECIATE THAT. >> DR. LEVINE, DO YOU WANT TO MAKE COMMENTS? >> IT'S ALL GOOD, IT'S ALL GOOD. I REALLY WANT TO SAY THAT THIS HAS JUST BEEN, I THINK IT'S A PERFECT TIME FOR ME TO TRANSITION OFF OF THIS COMMITTEE BECAUSE IT COMES WITH AN EXCLAMATION POINT, A SUCCESSFUL NEXT STEP TOWARDS ACHIEVING A PERSONAL OBJECTIVE THAT I HAVE HAD FOR A LONG TIME AND THAT IS--I'LL JUST TAKE YOU BACK, YOU KNOW 1520 YEARS AGO. IN MY OWN FIELD OF NEUROENDOCRINOLOGY, I COULD SEE FLAT OUT THAT AT A TIME WHEN CLINICAL TRIALS AND CLINICAL RESEARCH WAS BEING ADDRESSED IN TERMS OF SEX AND GENDER, THE WORST TRANSGRESSORS IN TERMS OF SKEWED RESEARCH ARE IN MY OWN AREA. AND EVEN TODAY, AS I'VE SAID, YOU KNOW SOME AREAS IN NEUROENDOCRINOLOGY AND NEUROSCIENCE ARE STILL IN THE STONE AGES. REGULATION OF BODY WEIGHT AND METABOLISM, STRESS RESEARCH, THAT 80% FIGURE I HAVE STATED MANY TIMES AS AN--AND I COUNTED THE NUMBER OF BASIC SCIENCE RESEARCH STUDIES IN RATS AND MICE, PARTICULARLY ON STRESS, 80% IN MALE. SO I JUST WANT TO THANK JEANINE FOR REALLY ACCELERATING THE FIGHT THAT--I'LL CALL IT A FIGHT THAT WAS STARTED ON VIVIAN'S WATCH EARLIER. AND TAKING THE PRAGMATIC AND DIRECT AND EFFECTIVE STEPS TO REALLY MAKE THIS--THIS ACHIEVEMENT REALIZIZABLE IN TERMS OF BASIC SCIENCE RESEARCH AND AS A BASIC SCIENTIST-- >> I'M GETTING VECLEMENT, I THANK YOU VERY HAVING HAD THE POLITICAL SKILL AND TACT TO BRING THIS TO FRUITION. I WANT TO LEAVE YOU WITH MY PHILOSOPHY, REMAINS THAT THERE SHOULD BE BOTH A CARROT AND LESS OF A STICK IN THIS PROCESS. AND NOT TO REGRESS IN ANY OF MY FEELINGS ABOUT HOW TO GET THIS DONE, BUT THE CARROT, I THINK IS GOING TO BE ESPECIALLY IMPORTANT RIGHT NOW FOR BASIC SCIENTISTS TO BUY IN, BASIC SCIENTISTS THAT ARE UNDER ENORMOUS PRESSURE TO GET GRANTS TO BEGIN WITH. WHO KNOW WHAT THEY HAVE TO DO AND NOW, I REALLY DON'T THINK THAT BY AND LARGE MOST BASIC SCIENTISTS ARE BIASED IN THEIR CHOICE. BUT HAVE BEEN COMPLIANT IN THE HISTORY LEADING UP TO THIS. I THINK THAT MORE THAN MOST THEY'LL BE GLAD TO DO THIS, THE GRUMBLING THAT YOU'LL HEAR IS PART OF THE GRUMBLING ABOUT NOT HAVING ENOUGH MONEY AND HAVING DIFFICULTY TO GET GRANTS TO BEGIN WITH. I DO THINK IT'S INCUMBENT UPON US AND THIS COMMITTEE GOING FORWARD TO TRY TO REDUCELET BLOW BACK THAT IS INEVITABLY GOING TO HAPPEN IN TERMS OF EDUCATING THE BASIC SCIENTIST ABOUT HOW THIS ISN'T GOING TO BE MORE COSTLY, HOW I CAN INCORPORATE IT. THEY ALREADY KNOW IT'S BETTER SCIENCE BUT TO GET THEM THROUGH THE ANXIETY OF THE GRANT REVIEW PROCESS AND I--YOU KNOW I WAS EARLY IN PUSHING FOR THIS THAT THERE SHOULD BE THE BEST WAY OF GOING ABOUT THIS IS TO HAVE A VALUE ADDED CLAUSE IN THE REVIEW PROCESS AND I THINK THAT'S BEEN ACHIEVED. TO TRAIN THE ATTENTION OF VIEWERS BY HAVING A CHECK OFF, HAD THEY CONSIDERED SEX AND GENDER IN THE REVIEW PROCESS, I'M UNDERSTANDING THAT'S IN PROCESS. SO SO I THINK THESE HAVE TO BE FOLLOWED NOW BY THE PRACTICALITYS OF THE FUNDING PROCESS. THAT EDUCATING THE INVESTIGATORS ABOUT BUDGETING AND PERHAPS ON TOP OF THIS, MAYBE SOME OUTOF THE BOX IDEAS LIKE NOW THAT YOU HAVE AN "IN" WITH BUILDING ONE PERHAPS HAVINGA AN INCREASED BUDGET LIMIT FOR MODULAR GRANTS UP TO 275, INSTEAD OF 250 FOR GRANTS THAT INCLUDE SEX AND GENDER IN THE EXPERIMENTAL DESIGN-- >> [INDISCERNIBLE] [LAUGHTER] >> I ALSO THINK THERE HAS TO BE CONSIDERATION AND AGAIN I'LL END WITH THIS, THAT THERE ARE SOME SEGMENTS OF THE RESEARCH COMMUNITY WHERE THE ZERO SOMETHING GAME IN TERMS OF THE RESOURCES THAT ARE AVAILABLE AND THIS HAS TO BE TAKEN INTO CONSIDERATION FOR EXAMPLE IN THE NONHUMAN PRIMATE WORLD SO YOU DON'T HAVE IT CIRCLING BACK AND CURTAILING FEMALE SPECIFIC STUDIES LIKE PC OS, BECAUSE OF A LACK OF DISCRETION SEEING THE BROADER PICTURE OF WHERE, YOU KNOW THOSE BALANCES CAN BE STRUCK WITH OTHER PROJECTS WHERE IT SHOULDN'T BE MANDATED. SO WITH THAT I WILL JUST SAY THANK YOU FOR THE EXPERIENCE. IT'S BEEN A PLEASURE WORKING WITH ALL OF YOU. JEANINE CONGRATULATIONS ON A FANTASTIC WELL DONE JOB AND NOW THE FURTHER CLIMB TO THE PINNACLE OF ACHIEVEMENT IN SEX AND GENDER RESEARCH SUPPORT. NTHANK YOU JOHN. THANKS FOR THOSE KIND WORDS AND WE HAVE--WE HAVE LOTS OF WORK TO DO. SO I'M REALLY EXCITED ABOUT THAT. DR. DEULANCY DO YOU WANT TO MAKE A FEW REMARKS? >> I DID. CAN YOU HEAR ME OKAY? >> WE CAN. >> YES. I THOROUGHLY ENJOYED THE DISCUSSION TODAY AND THINK IT REALLY IS EXCITING TO SEE OVER THE PAN OF FOUR YEARS THE CHANGE IN DIRECTION AND THE AMOUNT OF PROGRESS THAT'S BEEN MADE. AND I'VE ERESPONSIBLELY ENJOYED PARTICIPATE NOTHING THE DISCUSSIONS THAT HAVE SPECIFICALLY TO DO WITH DECIDINGOT ACTIONS THAT ORWH CAN TAKE THAT WILL ADVANCE THE AGENDA AND THE GREAT JOB THAT PEOPLE HAVE DONE IN ACTUALLY MONITORING THE PROGRESS WHOSE BEEN ABLE TO FOSTER, I'VE OLOGIES REAL LE ENJOYED THE DIVERSITY OF BACKGROUNDS OF PEOPLE ON THE ADVISORY BOARD AND I THINK THAT WAS ONE OF THE STRENGTHS, THAT IT WAS NOT JUST MEMBERS OF THE BIOMEDICAL RESEARCH COMMUNITY BUT OTHER INDIVIDUALS AS WELL THAT BROUGHT A BROAD PERSPECTIVE THEY THINK OVEN TIMES FOR MANY OF US THAT ARE IN THE SCIENTIFIC COMMUNITY IT WAS GOOD TO HEAR, TO HEAR HOW PEOPLE IN A BROADER SCOPE OF SOCIETY WOULD LOOK AT THINGS FELT I WAS VERY IMPRESS WIDE THE STRATEGIC PLANNING PROCESS AND HAPPY THAT THE PERIOD OF UNCERTAINTY OF THAT LEADERSHIP AT WORH ENDED UP WITH DR. CLAYTON BEING NAMED AND THE OFFICE REORGANIZATION AND THE ENERGY IN THIS MEETING HAVE MADE EVERYBODY VERY HAPPY WITH THE DIRECTION THAT THINGS ARE MOVING IN AND I KNOW THERE'S BEEN A LOT OF CHANGE IN THE OFFICE AND I KNOW THIS IS SOMETHING THAT'S TAKEN A HUGE AMOUNT OF EFFORT ON EVERYBODY'S PART, I THIS MEETING EVERYBODY'S ABOUT WHAT'S GOING ON AND THE NATURE ARTICLE AS EVERYBODY SENSED REALLY WAS A TRANSITION POINT AND NOW, I THINK THE QUESTION IS GOING TO BE, NOT WHETHER THIS--THINGS ARE GOING TO MOVE IN THIS DIRECTION BUT HOW TO ACCELERATE THAT--THAT MOVEMENT. I THINK TERESA CAPTURED IT NICELY IN HER TALK AND WE NEED TO THINK ABOUT WHAT ACTIONS WE CAN TAKE THAT WILL MAKE THE REALITY THAT WE'RE IMAGINING COME SOONER RATTLER THAN LATER AND I THINK THAT THE MANS ARE ALREADY IN PLACE FOR THAT. ONE OF THE CHALLENGES I SEE IS WHEN I THINK ABOUT THIS, THERE'S A VAST LANDSCAPE OF QUESTIONS THAT ARE PROBABLY IN THE MILLIONS IF NOT BILLIONS. EVERY DRUG, EVERY TREATMENT, EVERY DIAGNOSTIC TEST FOR EVERY DISEASE WILL HAVE A SEX ASPECT TO IT AND I GUESS THE QUESTION IS GOING TO BE WHAT'S THE NOBEL PRIZE WINNING INSIGHT THAT COMES OUT OF THIS NEW FIELD OF RESEARCH AND HOW CAN THINGS BE DONE IN SUCH A WAY TO BE ABLE TO MAKE SURE THE BIG PICTURE IS KEPT IN VIEW AND NOT JUST SIMPLY TO DO SEX DIFFERENCES RESEARCH TO DO IT BUT TO LOOK FOR THE TRANSFORM PFAATIVE OPPORTUNITIES WHERE THERE ARE MAJOR SHIFTS WE CAN MAKE AND I FEEL CONFIDENT THAT THAT'S IN PROCESS AND WILL--WILL MOVE ALONG. THE ONE THING THAT I HAVE TO SAY THAT I SOMETIMES THINK ABOUT IS WITH THE SHIFT TO SEX DIFFERENCES RESEARCH, SOME OF THE WOMEN'S HEALTH ISSUES THAT DON'T HAVE TO DO WITH SEX DIFFERENCES IN PAST, AS MANY OF YOU KNOW OUR INVESTIGATION CONCERNS WOMEN HAVE IN ROLE IN BIRTH AND CONSEQUENCES LATER IN LIFE WITH INCONTINENCE AND PROLAPSE AND SO FORTH, I WONDER ABOUT THE NECESSARY BALANCE AND IMPORTANCE WITH THE THINGS ON NECESSARY SEX DIFFERENCE, WITH THE THINGS THAT FOCUS ON THE SINGLE SEX AND THAT SEX BEING WOMEN AND I KNOW THAT THAT'S SOMETHING THAT THE OFFICE S&P SUPPORTIVE OF BUT SOMETIMES IN THE DIALOGUE TO PEOPLE NEW TO THE DIALOGUE, THEY DON'T NECESSARILY ALWAYS THINK ABOUT THOSE OTHER ASPECTS AS WELL, BUT THOSE ARE MINOR CONCERNS AND I YOU KNOW I THINK THAT THE TRAIN IS NOW MOVING AND IT WILL PICK UP SPEED OVER THE COURSE OF TIME AND THERE'S A FAVORITE QUOTE I HAVE OF WILLIAM JAM WHO IS IS HENRY JAMES THE NOVELIST'S BROTHER WHO IS ONE OF THE FATHERS OF MODERN NEUROSCIENCE WHO SAID: WELL OF COURSE AT FIRST THEY SAID IT WASN'T TRUE AND THEN AFTER THE TRUTH OF IT COULD NO LONG BE BEDENIED THEN OF COURSE THEY SAID IT ISN'T IMPORTANT AND THEN AFTER THE IMPORTANCE COULDN'T BE DENIEDED THEY SAID WELL OF COURSE IT ISN'T ANYTHING NEW AND I THINK WE'RE PROBABLY AT THAT TRANSITION POINT NOW WHERE PEOPLE ARE REALIZE THAT THIS IS NOT ONLY THE RIGHT THING TO DO BUT A RIGHT THING TO DO AND HOPEFULLY WITHIN THE NEXT FORESEEABLE FUTURE PEOPLE WILL LOOK AT IT AS JUST THE WAY WE NORMALLY DO BUSINESS AND PEOPLE WILL BE ABLE TO MOVE ON TO THE NEXT FOCUS AND I WANT TO ADD JEANINE THE WONDERFUL WORK YOU'VE DONE AND THE MANY THINGS YOU'VE DONE AND I WILL MISS BEING HERE AT THE ADVISORY MEETS AND THINGS ARE IN GOOD HANDS AND WE ARE LOOKING FORWARD TO EVERYBODY'S PROGRESS OVER THE COURSE OF TIME. >> THANK YOU VERY MUCH, JOHN. LET ME REASSURE YOU THAT THE FOCUS ON SEX AND GENDER INFLUENCES AND THAT'S THE WAY I TINK ABOUT IT, SEX AND GENDER INFLUENCES ON HEALTH AND DISEASE IS THE REASON WHY ORWH IS INTERESTED IN THAT IS BECAUSE THAT INFORMS AND IMPROVES WOMEN'S HEALTH. DIFFERENT PEOPLE ARE INTERESTED IN IT FOR VARIOUS REASONS BUT THAT WAS THE MOTIVATING FACTOR FOR ME TO BECOME INTERESTED IN IT, IN THE FIRST PLACE. WE WERE REMAIN DEDICATED TO WOMEN'S HEALTH AND ISSUES THAT ARE IMPORTANT AND SPECIFIC TO WOMEN AND IN PARTICULAR, I HAVE AN INTEREST IN LINKING THOSE ISSUES, THOSE REPRODUCTIVE ISSUES TO SYSTEMIC HEALTH ISSUES. AS YOU KNOW THE NATIONAL INSTITUTE ON CHILD HEALTH AND HUMAN DEVELOPMENT AS MATERNAL HEALTH IN THEIR SCOPE AS PART OF THEIR MISSION. I'M PARTICULARLY INTERESTED IN ASPECTS OF PREGNANCY, REPRODUCTIVE HEALTH, MACHINE O PAUSE THAT ARE--HAVE A ROLE TO PLAY IN A WOMAN'S OVERALL HEALTH. TIS PARSING KIND OF APPROACH WHERE YOU KNOW THIS IS ONE SLIDE HERE AND ONE SLICE HERE AND YOU KNOW A TRUE INTEGRATED, INTERDISCIPLINARY SYSTEM WIDE BY DESIGN APPROACH IS WHAT I AM TRYING TO FIND A WAY TO DO THAT. AND FOR THE ORD AND THE OFFICE OF THE DIRECTOR, AND CUTTIN A ROLE THAT'S PART OF MYICAL TOANCH ARRANGE SOMETHING LIKE THAT AND COORDINATE AND CREATE SOMETHING LIKE THAT BECAUSE THAT WOULD--THAT WOULD DEFINITELY BE MANY, MANY INSTITUTES AND CENTERS TO BE ONBOARD WITH THAT. I DID WANT TO REASSURE AND YOU THANK YOU FOR HIGHLIGHTING THAT. >> I HAVE FELT THAT THAT IS THE FOCUS ALSO, IT'S MORE JUST THE LANGUAGE THING THAT THE PEOPLE ON THE OUTSIDE SOMETIMES DON'T HAVE THAT. THEN OVER THE COURSE OF TIME THAT'S NOT AN ISSUE AT ALL BECAUSE IT'S--YOU KNOW NOW THAT YOU'VE DONE SUCH AS EFFECTIVE JOB AND RAISING THE ISSUE IN PUBLIC DIALOGUE, THAT WILL BE THE THING THAT ALLOWS PEOPLE TO FOCUS ON, ARE THOSE ISSUES AS WELL. >> BUT JOHN, DID--YOU MACK A GOOD POINT AND I WANT TO SAY THIS, IT'S REALLY IMPORTANT FOR US TO USE LANGUAGE ACCURATELY SO IF WE'RE TALKING ABOUT SEX DIFFERENCES THAT'S FINE BUT IF YOU'RE TALKING ABOUT SEX AND GENDER INFLUENCES OR GENDER, YOU KNOW FOR US TO CERTAINLY IN THE ARMY THAT WE FEED TO HELP EDUCATE PEOPLE ABOUT THE--ABOUT THAT AND SO SEX DIFFERE CANS SOMETIMES BECOME A BIT OF A SHORT HAND. IT'S REALLY IMPORTANT BECAUSE WE BED WHAT WE'RE TALKING ABOUT BUT A LOT OF PEOPLE DON'T UNDERSTAND WHAT WE'RE TALKING ABOUT AND THAT WE TAKE THE TIME TO REALLY EXPLAIN WHAT WE MEAN, AND LONG THOSE LINES WE DO HAVE AND WE WILL SEND YOU ONE, JOHN, THESE NEW CARDS THAT ARE HERE, YOU HAVE ONE AT YOUR TABLE. AND IT DESCRIBES THE STUDYING SEX STRENGTH AND SCIENCE, IT'S DECLARE CLARRAATIVE STATEMENT AND IN THE BACK IT'S IT IS FOUR Cs OF STUDYING SEX TO STRENGTHEN SCIENCE WHICH ARE REALLY VERY STRAIGHT FORWARD. I THINK EVERYONE SHOULD BE DOING THIS. IF YOU DON'T NEED A POLICY TO DO THIS. >> YEAH. >> CONSIDER--OKAY, THAT'S THE FIRST THE DESIGN STUDIES THAT TAKE SEX INTO ACCOUNT, LOTS OF WAYS TO DO THAT AND EXPLAIN WHY IT ISN'T INCORPORATED. COLLECT, THAT'S THE SECOND SEED, TABULATE SEX-BASED DATA, IT AMAZING THAT EVERYBODY DOESN'T DO THAT BUT THAT'S THE CASE. >> CHIERKTAISE SO ANALYZE SEX-BASED DATA. SEPARATE DATA FROM MALES AND FEMALES AND COMMUNICATE. THAT'S THE FOURTH SEED, SO AT A MINIMUM, EVERYONE SHOULD--THIS IS JUST A MARK OF GOOD QUALITY SCIENCE. >> YEAH. >> DR. REAGAN STEINER? >> THIS IS AN IMPORTANT POINT. THE SEX AND GENDER DISCUSSION, UNTIL THE PUBLIC UNDERSTANDS, ADDRESS THE PUBLIC A LOT WHEN YOU TALK ABOUT SEX AND GENDER, THEN YOU TALK ABOUT SEX DIFFERENCES, YOU'RE NOT TALKING ABOUT MEN AND WOMEN ARE DIFFERENT, WHICH EVERYBODY DOES KNOW, I THINK WE HAVE TO WORK OUT THESE TERMS AND THEN YOU HAVE TO EXPLAIN THEM BOTH TO OUR PROFESSIONAL COLLEAGUES AND THE LAY PUBLIC BECAUSE OTHERWISE YOU GET A LOT OF FUNNY LOOKS A LOT OF CONFUSION. >> SEVERAL PEOPLE BROUGHT UP THIS ISSUE SO THERE'S MORE WORK TO BE DONE THERE SO THANKS FOR FLAGGING THAT FOR ME, JUDY. THE INTEREST OF TIME VALLARY DID YOU WANT TO MAKE A COMMENT-- >> OKAY, I'M SORRY. >> OKAY. >> I JUST WANT TO ALSO MENTION THAT VALERIE S&P ROTATING AND I WANT TO THANK HER FOR HER SERVICE ASK ACKNOWLEDGE THAT WAS THERE A LAST COMMENT OVER HERE CARMEN? >> [INDISCERNIBLE]. --SORRY, I HAVE A GOOD FRIEND NOT MANY BUT A GOOD ONE. IT SEEMS TO ME AFTER THIS DISCUSSION AS PEOPLE ROTATE OFF IN CELEBRATION OF THE 25 YEAR FIST THERE'S SOMETHING BEING PLANNED,--I MEAN, YOU'RE-- >> [INDISCERNIBLE] >> WELL, I ALWAYS NEED A REASON FOR A DRESS, BUT I BEING THAT IT'S AN OPPORTUNITY TO CELEBRATE. I MEAN PARTICULARLY--I'LL JUST SHUT UP. >> NO, NO OF COURSE WE NEED TO ACKNOWLEDGE AND CELEBRATE THE 25 YEARS OF INCREDIBLE WORK DONE BY MANY, MANY PEOPLE AND CERTAINLY WE ARE THINKING ABOUT THAT ASK WE WELCOME YOUR INPUT ON WAY YOU THINK THAT MIGHT BE EFFECTIVE UNDER THE CIRCUMSTANCES OF ALL THE THINGS THAT ARE ONGOING BUT DEFINITELY WOULD LOVE TO HEAR FROM YOU AND YOUR THOUGHTS ON THAT. AND WHAT WE CAN DO BECAUSE WE'RE A LITTLE OVER, WHY TONIGHT WE TAKE A 15 MINUTE BREAK NOW AND COME BACK--WELL WE CAN'T DO THAT. ONE SECOND. >> OKAY WE'RE AHEAD OF TIME WE WILL TAKE A BREAK AND HAVE A LONGER DISCUSSION. SO THIS IS A NICE NATURAL BREAK PERIOD SO COME BACK IN 15 MINUTES. >> WE'LL HAVE OUR DISCUSSION OF ANYTHING YOU WANT TO DISCUSS FROM THE DAY OR ANYTHING AT ALL. THANK YOU VERY MUCH. >> JOHN WILL BE AWAY FOR 15 MINUTES. >> OKAY, I'LL BE HERE. >> THEY'RE FANTASTIC BUT THEY'RE--IS THERE A WAY TO--SINCE ETHICS TRAINING IS NOT VOLUNTEERS UNSUPPORTED TEARY IS THERE A WAY TO INCORPORATE THIS PIECE INTO A IT? >> I HEAR YOU. >> MAKING IT MANDATORY, DR. LEVINE? >> MAYBE THERE'S CLARIFICATION HERE COULD IT BE, I MEAN INCORPORATING OR THINKING ABOUT SEX AND GENDER AND EXPERIMENTAL TO DESIGN IN SOME WAY IS AN ETHICAL ISSUE. SO COULD IT NOT SIMPLY BE INCORPORATED INTO THE REQUIREMENT--ETHICS TRAINING REQUIREMENT FROM THAT PERSPECTIVE? >> I DEFINITELY THINK IT MAKES PEOPLE THINK ABOUT IT DIFFERENTLY IF YOU DO THAT. BECAUSE PEOPLE DO NOT THINK OF IT AS AN ETHICAL ISSUE. WE DO BUT OTHERS PROBABLY HAVE NOT SO THAT'S A PERSPECTIVE AND I BET YOU WE CAN FIND SOME GOOD LITERATURE ON THAT TO SUPPORT THE REASONING BEHIND THAT. >> THANK YOU. >> SO THIS IS NOT REALLYALATED TO THAT. SO CAN I--SO THE OTHER FRAMEWORK FROM WHICH WE'RE FUNCTION SUGGEST IS EQUITY, JUSTICE AND EJITY AND OUR SCIENCE AS BEEN WHAT'S BEEN VERY MALE CENTRIC AND WE ARE CHANGING THAT IN TERMS OF SEX, HOWEVER, I ALSO FIND DIALOGUE FOR SOMETHING THAT NEEDS TO CHANGE IN THE DIALOGUE AND THAT IS THAT IT IS NOW SO MEDICINE CENTRIC AND HEALTH SCIENCE SYSTEM BROADER THAN THAT, AND IT'S THE TEAM OF PEOPLE WHO TAKE CARE OF PATIENTS AND WHEN WE SAY FOR EXAMPLE THAT WE NEED TO CHANGE MEDICAL EDUCATION TO INCORPORATE SEX ED, IT SHOULD SAY WE NEED TO CHANGE HEALTH PROFESSIONAL EDUCATION TO INCLUDE SEX IN IT BECAUSE LANGUAGE IS REALLY IMPORTANT. WE HAVE AN OPPORTUNITY NOW TO REALLY DO WHAT WE PREACH AND WE PREACH EQUITY. WE PREACH EQUITY AND SCIENCE AND WE NEED TO PREACH EQUITY IN TERMS OF HEALTH SCIENCES BECAUSE THE TEAM HAS A PHARMACIST AND NUTRITIONIST AND NURSE AND IN FACT NURSES ARE THE ONE WHO IS SPEND MOST OF THE TIME WITH PATIENTS AND IF WE WANT ADVOCACY AND IF WE WANT PATIENTS TO REALLY UNDERSTAND HOW IMPORTANT WOMEN PATIENTS TO UNDERSTAND HOW IMPORTANT SCIENCE THAT INCORPORATES THEM IS, THEN I THINK WE NEED TO EDUCATE NURSES TO BE ABLE TO DO THAT BUT IT'S OUR LANGUAGE AND REALLY SPEAKING ABOUT OUR LANGUAGE BECAUSE WE HAVE THIS OPPORTUNITY TO TAKE THAT EQUITY IN ALL LEVELS AND IT'S EQUITY BETWEEN THE SCIENCES AND IT'S NOT MEDICINE ANYMORE THAT DOMINATES HEALTHCARE. >> SO, DR. RICE ONE SECOND, SO YOU'RE ABSOLUTELY RIGHT AND I WANT TO MAKE SURE THAT YOU NOTICED ON YOUR CARD THAT THERE ARE CNE AND CPEs ON THIS SO WE'VE EXPANDED AT LEAST FROM THE PART OF THE CURRICULUM THAT WE'RE INVOLVED WITH BUT YOU'RE CORRECT. I OFTEN SAY CLINICIANS CARE OR HEALTHCARE PROVIDER SO THAT WAY COULD BE ANYONE BUT YOU'RE RIGHT WE NEED TO CHANGE OUR LANGUAGE, VALLARY? >> I WAS GOING TO SAY SOMETHING SIMILAR, HOW HAVE WE DISSEMINATED THIS INFORMATION TO OTHER PROFESSIONALS AND THEN LOOKING AT THE WORK THAT WE'RE DOINGS WITH IT IS AAMC, OR THE ACCREDITATION OR IN OTHER ACCREDITATIONS STANDARDS WITHIN PROFESSIONAL EDUCATION ARE THERE OPPORTUNITIES TO MAKE SURE THAT THIS INFORMATION IS BEING DISSEMINATED IN SOME OF OUR TRAINING IN OUR PROCESS. THANK YOU FOR THOSE SUGGESTIONS, I REALLY APPRECIATE IT. >> AMBER AND THEN HEIDI. >> I WANT TO MAKE THE COMMENT I MEANT TO MAKE EARLIER WHERE IT WAS MORE IN CONTEXT BUT IT'S WORTH REPEATING THIS. SO AT A TIME WHERE FUNDING IS SORT OF THE MOST CRITICAL THING, UNPRECEDENTED TIME OF OPPORTUNITIES, SCIENTIFICALLY BUT THE FUNDING LIMITATION, BUT BY FAR THE MOST POWERFUL THINGS S&P TO TAKE IT, YOU KNOW TAKE THE FIELD FROM THE LEVEL THAT IT IS AND TO WHERE IT'S SUPPOSED TO TO THE NEXT LEVEL IS BY INCLUDING NOT JUST AT THE BOTTOM OR SOME INVISIBLE LINE SOMEWHERE BUT IN THE APPROACH SECTION THAT'S ONE OF THE MAIN CRITERIA. BECAUSE EVERYBODY WRITES THESE GRANTS. AND THERE ARE GRANTS THAT GET FUNDED. SO IT'S NOT THE LACK OF THE YOUNG PEOPLE THAT WANT TO STUDY SEX DIFFERENCES SO EVERYBODY COMES TO US IN OUR CENTER, COMES FOR THAT REASON. IT'S REALLY THEN ONCE AGAIN, ONCE IT GETS TO THE K-AWARD AND THE FIRST RO-1 THEN THE QUESTION COMES YOU, YOU KNOW SHOULD I CONTINUE THIS SORE SHOULD I FOCUS ON PREVENTATIVE SCIENCE AND THEN IT'S REWARDED, FINANCIAL REWARDED WITH THE [INDISCERNIBLE]. THE OTHER QUICK COMMENT, FOR SIX VERSES GENDER, I THINK IT WOULD BE GOOD TO PUT ON THE RECORD, BUT IT WILL BE A SHAME TO GO BACK AND SEPARATE THE GEBDER ROLE FROM THE BIOLOGICAL SEX, IT'S A [INDISCERNIBLE] IN MY OPINION. I THINK THEY'RE TWO VERY DIFFERENT THINGS AND WITH THE PUBLICITY AND FOCUS ON THE SOCIETY OF GENDER ISSUES REEBTLY, IT'S MORE IMPORTANT THAT IS IT NOT REALLY--NOT REALLY INTERESTED IN STUDYING MANY, YOU KNOW SOCIOLOGICAL POLITICAL, CULTURAL ASPECTS OF OF THE DIFFERENCES. I THINK THE MAIN THING HERE IS ON THE BIOLOGICAL DIFFERENCE AND IT'S SORT OF MY UNDERSTANDING, NOT THAT NONBIOLOGICAL THERAPIES WILL HAVE [INDISCERNIBLE] BUT THE SUBSTRATE SHOULD BE BIOLOGICAL AND SHOULD BE SEPARATED THAN PEOPLE HEAR WHAT SOMEBODY'S TALKING ABOUT. AND FINALLY A VERY SHORT COMMENT. THIS EFFORT ON PRECLINICAL RESEARCH AND SEX DIFFERENCE IN PRECLINICAL STUDIES, I THINK VERY IMPORTANT PART OF THIS AND I'M SURE IT'S ADDRESSED IN IN WORKSHOP THAT ARE HAVING THAT SEX DIFFERENCES ARE ISSUES DEPENDENT AND THE SEX DIFFERENCE IN SOME TRAIT IN THE ANALYSIS OF THE RAT, DOES NOT NECESSARILY HAVE TO TRANSLATE TOO ANY DIFFERENT HUMAN WHO IS FOUND US IN MAINTAINING MANY TIMES, IT'S SURPRISES EVERYBODY THAT ONE GROUP FOR TRAUMATIC DIFFERENCES IN THE PAIN IN THE ANIMALS BUT WE DON'T SEE THIS REALLY IN OUR IMPLEMENTATION AND AGAIN MAYBE WITH MONKEYS BEFORE A HOST OF HUMANS BUT WITHOUT THAT COMPONENT IT'S GOING TO LEAD TO UNEXPECTED NEGATIVE CONSEQUENCES BEFORE CLAIMING THERE'S--YOU KNOW THAT THE SEX DIFFERENCES AND BASED ON THE MOUSE STUDIES BUT YOU DON'T SEE THEM IN HUMANS. SO, I THINK TO MAXIMIZE TRANSLATION WHICH IS REALLY OUR ULTIMATE GOAL, I THINK [INDISCERNIBLE]. >> THANK YOU FOR BRINGING UP THOSE POINTS AND I'M SURE THEY WILL COME UP IN WORKSHOPS AND AS I'M TALKING ABOUT THIS THE WHOLE, USING THE AN MOLL MADLE, WHETHER YOU CHARACTERIZE SOME PARTICULAR PHYSIOLOGIC WAG A OR MODEL OF HUMAN DISEASE, ALL THAT HAS TO BE TAKEN IN CONSIDERATION WEN YOU DESIGN YOUR EXPERIMENT, SO THANK YOU FOR THOSE REMARKS. DO YOU WANT TO RESPOND OR I WILL SAY ONE THING. >> OKAY? >> WE AT ORWH ARE PARTICULARLY CONCERNED ABOUT THE AFFECTS OF SEX AND GENDER ON HEALTH AND DISEASE, BOTH. THIS PARTICULAR POLICY WE'RE WORKING ON RIGHT NOW DOES NOT TAKE THE PLACE GENDER AND IT'S EFFECT ON HEALTH THAT,'S CONFINED TO THE PRECLINICAL AREA AT THE PRESENT TIME BUT THAT'S WHERE I'M USING THE TERMINOLOGY SEX AND THERE THE PRIMARY GOAL IS TO MAKE SURE WE HAVE A STUDY OF BOTH SEXES AND WE ADDRESS THE GAP AND UNDERSTANDING ABOUT FEMALE BIOLOGY AND GOING FORWARD THAT WE WILL GET BIOLOGY OF BOTH SEXES AND WE KNOW VERY WELL THAT THERE ARE HUGE NUMBER OF FACTORS THAT AFFECT HEALTH AND I WOULD SAY, CERTAINLY GENDER IS ONE OF THEM AND BEHAVIOR WHICH CERTAINLY IS AFFECTED BY GENDER IS ANOTHER AND YOU COULD HAVE THE BEST TREATMENT IN THE WORLD BUT AS PEOPLE DON'T TAKE IT, IT'S NOT GOING TO WORK. SO I'M CO CHAIRING ALONG WITH DR. RICHARD HOTUS, THE SEARCH FOR THE DIRECTSOR THE OFFICE OF BEHAVIORIAL AND SOCIAL SCIENCE RESEARCH AND THESE ISSUES ARE REALLY VERY IMPORTANT, CROSS-CUTTING AND IMPORTANT TO ALL OF US SO THE WAY I THINK ABOUT IT IS THAT THERE'S SO MANY THINGS THAT AFFECT HEALTH AND DISEASE AND YOU HAVE TO THINK ABOUT ALL OF THEM, THE ENVIRONMENT, GENETICS SOME OF THESE THINGS, SOME OF THEM NEED TO BE CONSIDERED TO BE FUNDAMENTAL AND MIGHT BE CONSIDERED FIRST. THERE ARE RECOLLECT THINGS THAT ARE IMPORTANT AND MAY BE AS IMPORTANT IN PARTICULAR RESEARCH CONTEXT AND THE CONTEXT OF A SPECIFIC RESEARCH QUESTION. EACH OF THE SCIENTISTS SHOULD UNDERSTAND THAT THE BEST, THE SCIENTISTS WHOSE DOING THE RESEARCH, WHAT'S AFFECTING MY RESEARCH. AND THEY HAVE TO ACCOUNT FOR THOSE VARIABLES, SO I JUST WANT TO LET YOU KNOW, WE ARE CONCERNED ABOUT THOSE ISSUES THAT'S SEPARATE FROM WHAT WE'RE DOING NOW AND IN WHAT WE'RE SPEAKING ABOUT BUT IT REMAINS SOMETHING WE'RE THINKING ABOUT AND IT IS IN OUR STRATEGIC PLAN SO I WANT TO CLARIFY THAT. >> YOU WANT TO MAKE A COMMENT? , -- >> NOTHING FURTHER TO SAY THAT IT IS IMPORTANT TO CONSIDER GENDER AND GENDER IS BROADER THAN SEX AND WE CANNOT IGNORE THE MEANING OF GENDER AND HOW GENDER AFFECTS THE HEALTH-- >> [INDISCERNIBLE]. >> THANK YOU. HEIDI? >> HI THIS, IS A DIFFERENT TRACK, I'M TALKING ON NOW, I JUST WANTED TO MAYBE PUT A SUGGESTION TO--IN OUR LANGUAGE AND PRESENTING THIS MATERIAL, MAYBE EXPANDING OUR IDEA TRANSLATION TO OFFER POPULATION SCIENCE, JUST AS IT LOOKS LIKE THE TERM PERSONALIZED MEDICINE IS BEING MORE EMBRACED, AND TAKEN--THEY'S MORE INDIVIDUALIZED TREATMENT OR DIAGNOSTICS FOR PEOPLE, HOW SYSTEMS NOW ARE ORGANIZING POPULATION MEDICINE SO THERE ARE HUGE INITIATIVES ON THAT SIDE OF THE DELIVERY SPECTACLE RUM AROUND POPULATION, SO IF WE CAN CONSIDER AN EVEN BROADER VIEW OF TRANSLATION TO ALIGN WITH THAT, THAT WILL BE CURRENT WITH WHAT'S GOING ON THERE AND AGAIN REENFORCES THE POINT THAT THE RESEARCH DONE AT THE VERY BEGINNING OF THAT SPECTRUM, WE NEED TO KNOW ALL THOSE SUBGROUPS AND PARTICULARLY THE SEX DIFFERENCES ROLL ON UP TO POPULATION MEDICINE. THAT'S HUGE. SO IT WOULD REENFORCE WHAT WE'RE DOING BUT TO BROADEN THAT LANGUAGE A LITTLE WOULD BE NICE. >> THANK YOU. >> DR. WEAVER AND THEN DR. GREEN? >> SO I WOULD LIKE TO HAVE MORE DIALOGUE ON HOW WE GO BEYOND THE HEALTHCARE PROFESSIONALS AND THE RESEARCHERS TO PURSUE THIS DIALOGUE TO TAKE, YOU KNOW TO THE LAWYERS AND THE HOSPITAL ADMINISTRATORS AND THE PATIENTS AND WHAT NOT TO NOT HAVE THE DRIVER OF WHETHER OR NOT TO INCLUDE WOMEN IN TRIALS AND RESEARCH BEING THE LIABILITY AND LET'S DO EVERYTHING TO AVOID RISK, BUT, THE DRIVER BE--WE'RE NOT SERVING, KEY SEGMENTS OF THE POPULATION IF WE DON'T TEST. I WAS REALLY MOVED WHEN THEY SAID WHEN WE HEARD THE PREGNANT WOMAN GETS SICK, YOU KNOW? SO THERE SHOULD BE AN OUTCRY. HOW DO WE COMMUNICATE? COULD WE REACH PEOPLE TO START THAT MANTRA, THAT CONVERSATION? >> SO DISCUSSION? DR. PALMER? >> I WOULD LIKE TO FOLLOW UP ON THAT ONE OF THE THINGS I FOUND WHEN WE TALK TO PEOPLE IN THE COMMUNITY, WE TALK ABOUT RESEARCH, IT'S NOT WELL UNDERSTOOD AND I WAS MAKING A COMMENT EARLIER OF PEOPLE NOT WANTING TO GIVE PERSONAL INFORMATION AFTER RECEIVING SO MANY PUBLIC SERVICE MESSAGES ABOUT PROTECT, PROTECT, PROTECT. AND SO THERE'S MIXED MESSAGES FLOWING AROUND AND SOMETIMES WE UNDERESTIMATE PEOPLE AND WE THINK IN TERMS OF HEALTH LITERATEERACY, BUT WITH WE TALK ABOUT OUR MESSAGES THEY TALK ABOUT HOW IS THIS RELEVANT TO ME. THEY GET THE GIST OF WHAT WE'RE TALKING ABOUT BUT THAT YOU DON'T SEE THE RELEVANCE TO THEM. AND. AND WITH WE SAY TO PEOPLE, DRINK 8-OUNCES OF WATER A DAY, THEY SAY WHATTA A CUP, MY COFFEE CUP, MY TEA CUP, AND TO CARRY THIS FORWARD TALKING ABOUT GENDER, THINKING IT'S THE MORE POLIT TERM THAN SEX AND BRINGING THE MORE DIRECT TERM, THERE CAN BE THAT KIND OF CONFUSION SO I THINK A REAL DIALOGUE NEEDS TO GO ON. TWO PEOPLE ABOUT WHY WE SAY SEX AND WHAT--HOW IT IS RELEVANT TO YOU, YOUR GRANDDAUGHTERS, YOUR NIECES AND NEPHEWS, AND YOUR NIECES AND SO FORTH AND THE MEN IN THEIR LIVES, TOO. SO ANYWAY,-- >> I DON'T KNOW ENOUGH ABOUT IT BUT IS PC OI, A VENUE WHERE--YEAH? IT SOUNDS LIKE IT MIGHT BE A VENUE. PATIENT ORIENTED, WOULD THAT GET TO MORE PEOPLE? >> SO PC OI IS NOT A GOVERNMENT ENTITY BUT IT IS AFFILIATED AND SO I'M NOT SURE. I THINK THAT WHAT I'M HEARING FROM YOU IS THAT THERE'S--IT'S IMPORTANT FOR US TO DEVELOP, COMMUNICATION AND OUTREACH STRATEGIES AROUND THE USE. BOTH OF THE TERMS, THE MEANING OF THE TERMS AND ALSO WHAT IT MEANS TO PARTICIPATE IN CLINICAL RESEARCH. AND HOW YOU CARE AND THE TREATMENT YOU RECEIVE IS BASED ON INFORMATION THAT WAS DERIVED BY SOMEBODY LIKE THAT, THAT YOU'RE PART OF THE SOLUTION AND THAT'S THE WAY WE GET THAT INFORMATION IS BY YOU BEING IN A STUDY. BUT WE ARE SEEKING TO COLLAB EIGHT WITH THE OFFICE OF WOMEN'S HEALTH AT THE FDA AS A RESULT OF THE ACTION PLAN AROUND CLINICAL TRIALS PARTICIPATION BUT I'M HEARING MORE IS A BROADER NEED FOR OUTREACH AROUND THESE TERMS AND AROUND WHERE DOES THE INFORMATION COME FROM? WHERE DOES THE DATA COME FROM? D. >> I DON'T KNOW IT MAY BE BROADER THAN HOSPITALS HERE BUT FOR THE LAWYERS AROUND HERE BUT IT'S ALSO A LIABILITY FOR NOT INCLUDING THAT SEGMENT OF THE POPULATION. >> SO MARKETING THOSE IDEAS AND MAKING THOSE MORE, WE NEED TO USE DIFFERENT PRONGS AND ONE OF THE PRONG SYSTEM EDUCATION OF THE YOUNG GENERATION IN ALL HEALTH SCIENCES. SO THAT'S ONE GROUP BECAUSE THAT'S REALLY THE FUTURE, SO ANOTHER PRONG IS ORGANIZATIONS. I HAPPEN TO BE CO CHAIRING THE IOM FORUM FOR INTERPROFESSIONAL EDUCATION. WE HAVE 45 ORGANIZATIONS, HEALTH ORGANIZATIONS WHO ARE MEMBERS OF THAT. ASK WHAT WE ARE DISCUSSING, IS HOW--THAT'S WHY WE NEED TO CHANGE THE LANGUAGE FROM MEDICINE CENTER TO HEALTH SCIENCES BECAUSE IT'S AMAZING TO ME TO LOOK LIKE MY CO CHAIR WHO WAS THE--YOU KNOW THE AAMC PRESIDENT AND WE LOOK AROUND THE ROOM AND WE SAY MY GOD, LOOK WHAT'S HAPPENING HERE, 45 ORGANIZATIONS WANT TO JOIN THIS FORUM TO TALK ABOUT TRANSFORMATION IN THE EDUCATIONAL HEALTH PROFICIENTS FOR THE FUTURE AND THEY'RE ALL SITTING AROUND THE SAME TABLE TALKING ABOUT IT FOR THE LAST THREE YEARS SO THAT WOULD BE ANOTHER PRONG WHERE THIS INFORMATION SHOULD BE PRESENTED BECAUSE THEY CAN GO BACK TO THE ORGANIZE EGG, YOU COULD HAVE SPEECHES AND YOU HAVE THESE ORGANIZATIONS TO PRESENT THIS ASK WE UPON HELP WITH THAT SO IT'S A MARKETING STRATEGY THAT IS MORE COMPREHENSIVE. >> THANKS FOR THE SUGGESTION. I'LL BE CALLING YOU ABOUT THE NAME OF THAT ORGANIZATION, WE CAN HEAR ABOUT THE 45. CARMEN DID YOU HAVE A QUESTION? , I THINK I MISSED NUAND THEN DR. BECKER USE YOUR MICROPHONE, PLEASE. >> OH, BECAUSE SHE WANTS TO KEEP IT FOR HER MINUTES. I GET IT, SHE WANTS TO PROVIDE ATTRIBUTION. THIS IS [INDISCERNIBLE] NEVER TO ADDRESS ME WITHOUT IT, OKAY? [LAUGHTER] I NEED TO SAY A FEW COMMENTS. THERE WAS A FIRST ONE WAS, YOU KNOW AGAIN I WANT TO ALEWD YOU ON THE CONCERTED EFFORTS BUT I ALSO THINK WE THEY'D TO THINK ABOUT THE CONCERTED EFFORTS AS IT RELATES TO WOMEN OF COLOR. AND IT MAY BE AN OPPORTUNITY TO SORT OF THINK ABOUT THIS AS WE THINK ABOUT INCREASING, DIVERSIFYING POPULATION. FOR THE FIRST TIME IN THIS COUNTRY'S HISTORY, NONWHITE CHILDREN OUTNUMBER, LESS THAN FIVE, OUTNUMBER WHITE CHILDREN. SO IT'S COMING AND ALL THE THINGS YOU'RE DOING IN A FORWARD FASHION, VISIONARY APPROACH I THINK IT MAY BE TIME--I DON'T KNOW IF MEANS A TASK FORCE BUT HOW DO WE MAKE CERTAIN THAT THE PAPERS AND PRESENTATIONS ARE RELEVANT FOR AN INCREASINGLY DIVERSIFIED POPULATION. SO THAT'S ONE COMMENT AND THAT MAYBE WE NEED TO HOLD PEOPLE ACCOUNTABLE TO THAT AS WELL. NOW I KNOW THAT THERE ARE BROWN MICE AND WHITE MICE AND GRAY MICE AT THE BASIC SCIENCE LEVEL AND THAT PROBABLY DOES MAKE A DIFFERENCE, IT DOES MAKE A DIFFERENCE AT THE HUMAN LEVEL PARTICULARLY AS IT RELATES TO DISPARITIES AND I KNOW YOU ARE SENSITIVE TO THAT, BUT I WANT TO GET IT ON THE RECORD. THERE WAS--PEOPLE WHO ENCOURAGE ME TO LEAD IN REGARDS TO A MODULAR BUDGET AND I ACTUALLY LOOKED AT THE PROPOSAL SO I'M NOT CERTAIN THEY'RE READY FOR A RECOMMENDATION, BUT I THINK IT MAY BE WORTH WHILE TO SORT THINK ABOUT WHETHER THERE'S INCENTIVES THAT COULD BE ADDED TO THE MODULAR BUDGET SO MAYBE AS A PEOPLE COULD WORK ON THAT AND SEE WHETHER OR NOT THAT WOULD BE FEASIBLE BECAUSE YOU KNOW YOU HAVE A LIMITED BUDGET AND SOMEBODY THE NEXT THING HAVE YOU THAT AND THEY SAY TAKE IT OUT OF YOUR BUDGET AND I DON'T THINK THAT'S HOW WE WANT TO PLAY THIS GAME. >> I THINK, THIRD POINT I HAVE IS REALLY--FOR A CELEBRATION OF THE 25 YEARS AND I THINK THAT DOES NEED THOUGHTFUL TYPE OF CONSIDERATION I MEAN WHERE THIS IS SORT OF, I THINK IT IS SOMETHING VERY, VERY SMALL THAT'S BUILT UP AND WE'RE GOING TO ANOTHER TRANSFORMATION AND I THINK IT'S AN OPPORTUNITY TO TRANSFER TO CELEBRATE THE SUCCESS. WHAT THAT LOOKS LIKE, SOUNDS LIKE YOU MAY HAVE HAD CONVERSATION WHERE THAT WOULD--YOU KNOW BUT OTHER ORGANIZEINIZATIONS OF NICHD WHEN THEY HAD SIGNIFICANT MILESTONE VS HAD CELEBRATIONS AND I DON'T KNOW IF THAT'S SOMETHING YOU NEED OUR HELP FROM, WITH, BUT I DO THINK IT'S AN OPPORTUNITY TO CELEBRATE AND I THINKER THINK THAT--WELL I'LL HAVE YOU RESPOND. >> DO YOU THINK THAT IS AN AREA AROUND WHICH YOU ALL WOULD LIKE TO DO A SMALL ADHOC WORKING GROUP AROUND THE 25th ANNIVERSARY, HELPING US TO PLAN THAT? WHAT WE MIGHT DO? SOME INPUT? >> SURE. >> SURE. >> GREAT. THANK YOU. >> ARE THERE RESOURCES FOR THAT? WHAT ARE--KEEP YOUR FINGERS TO YOURSELF. [LAUGHTER] >> WE SHOULD HAVE A WORKING GROUP THAT WAY WE CAN HAVE THAT CONVERSATION AT THAT TIME. >> OH, GOT IT. >> IT'S MY OPPORTUNITY TO KEEP IT FROM RAISING THAT CELEBRATION. >> I DO THINK THERE ARE ENOUGH ORGANIZATIONS WHO ARE EXCITED ABOUT WHAT HAS BEEN ACCOMPLISHED AND THAT THEY WANT TO CONTRIBUTE IN SOME WAY AND FOR US, IT'S NOT SO MUCH--IT'S ALWAYS NICE TO GET A NEW DRESS BUT IT'S ABOUT RAISING THE AWARENESS AND I THINK WE USE IT AS AN OPPORTUNITY TO BRING YOUNGER WOMEN SCIENTISTS OR YOUNGER SCIENTIST WHO IS ARE INTERESTED IN GENDER--SEX GENDER/RESEARCH TO GET THEM ENGAGED, THAT'S WHAT I WOULD LIKE TO SEE AS AN OORTUNITY TO BRING THEM INTO WOULD FOLD. BUT I THINK WE COULD DEFINITELY ASK FOR SUPPORT FROM THE MULTITUDE OF ORGANIZATIONS THAT ARE FOCUSED ON WOMEN'S HEALTH AND IF WE ALL GIVE A LITTLE BIT THEN THAT CAN BE CUMULATIVE BUT THEN MAYBE GIVE OUT FUNDING, PILOT FUNDING. >> EATEIVE SUGGESTIONS HERE, THANK YOU FOR THOSE THOUGHTS AND FOR YOUR ENCOURAGEMENT FOR US TO THINK I LITTLE BIT BIG FOR THE 25th. SO WE'LL HAVE MORE DISCUSSIONS. OTHER COMMENTS? DR. BECKER? >> SO I HAVE A COUPLE OF COMMENTS ONE RELATES TO THE ANIMAL MODELS. AS WE'RE MOVING FORWARD TO INCLUDING BOTH MALES AND FEMALES ONE OF THE THINGS THAT PEOPLE NEED TO BE AWARE OF IS THAT THE SOCIAL STRUCTURE FOR OTHER SPECIES IS QUITE DIFFERENT AND RATS ARE DIFFERENT THAN MICE ASK HAVING WAYS TO INCORPORATE LIKE RATS ARE THE MOM AND THE DAUGHTERS STAY WITH THE NATAL GROUP AND THE MALES DISBURSE, MICE ARE HAREM BREEDERS AND THEY DON'T HAVE THE SAME TYPE WHERE THE MALES LIVE WITH THE FEMALES IN A LARGE GROUP WHILE THE FEMALE LIVE IN THE SOCIAL STRUCTURE FOR RATS AND MALES ARE INDEPENDENT TERRITORIAL ANIMAL SO HAVE YOU A DIFFERENT--A VALID STRESS FOR A RAT MIGHT NOT BE THE SAME THING AS A VALID STRESS FOR A MOUSE, THAT'S MY LITTLE RODENT THING. ON THE OTHER HAND, I WAS WAS THINKING ABOUT SHERRY'S TALK AND OTHER THAN MY EXCITEMENT OVER HER DATA BUT THE USE OF META-ANALYSIS, TO TAKE DATA AND COMBINE IT WITH INFORMATION FROM PHARMACEUTICAL COMPANIES AND OTHER STUDIES WHERE WE DIDN'T SEE DIFFERENCES BEFORE AND THEN START TO PULL OUT BIGGER FINDINGS, I THINK IS SOMETHING THAT WE SHOULD BE TRYING TO LEVERAGE BECAUSE THAT SHOWS MORE DRAMATICALLY HOW THERE'S A LOT OF DATA OUT THERE ALREADY THAT WE HAVEN'T DAKEN ADVANTAGE OF AND THAT SORT OF LED ME TO THE WHOLE BIG DATA MOVEMENT RIGHT NOW AND THE FACT THAT THERE'S A LOT OF INFORMATION GOING ON ABOUT HOW TO START DOING IT SO THAT WE'RE AT A POINT WHERE WE MIGHT BE ABLE TO LEVERAGE THE NEW KNOWLEDGE, NEW STATISTICAL POWERS THAT ALLOW US TO DO THESE ANALYSIS THAT WE MIGHT NOT HAVE BEEN ABLE TO DO IN THE PAST AND THAT WOULD BE SOMETHING I THINK WE SHOULD BE PURSUING. >> THANK YOU FOR THE COMMENT. I'VE HAD MY FIRST MEETING WITH THE NEW ASSOCIATE DIRECTOR FOR DATA SCIENCE HERE PHIL BOURNE BUT HE WAS KNEW AND I TOLD HIM I WOULD HAVE TO COME BACK AND CHAT WITH HIM AFTER HE GOT HIS SEA LEGS. SO OF COURSE, ABSOLUTELY ONE OF THE AREAS OF INTEREST. KAY DICKERSON AS YOU KNOW HEADS UP THAT GROUP AT THE COCHRAN WILL BE A SPEAKER AT OUR METHODS WORKSHOP OR THE INTERDISCIPLINARY SYMPOSIUM SO THAT'S NOVEMBER 6th AND THAT WILL BE LIVE VIDEOCAST AND SHE HAS WRITTEN EXTENSIVELY ON INCORPORATING GENDER ANALYSIS INTO MET ANALYSIS BUT THANK YOU FOR BRINGING IT UP BECAUSE IT'S A WAY TO DEMONSTRATE VALUE ADDED TO A DIFFERENT COMMUNITY AND WE DO NEED TO TAKE EVERY ASPECT AND EVERY DOMAIN INTO CONSIDERATION WHEN WE MAKE THE SCIENCE CASE, WHEN WE MAKE THE BUSINESS CASE, WHEN WE MAKE THE EVIDENCE CASE, THE LAWYERS, THESE ARE ALL CASES WHEN I TITRATE AND ADJUST MY MESSAGE FOR WHOEVER I'M SPEAKING WITH BUT THAT'S CERTAINLY AN IMPORTANT AREA, TOO. >> OKAY, WE ARE ALMOST--WE HAVE FOUR MINUTES TO 3:30 WHEN WE DO OUR COMMENTS RIGHT AT 3:30. >> DR. REAGAN STEINER? >> YOU WOMENTIONED POSSIBILITY OF SMALL WORKS GROUPS AND WE HAVE THE PARTY PLANNING AND EVENT GROUP IDENTIFIED. >> [INDISCERNIBLE] >> SORRY. >> SCIENTIFIC-- >> RECOGNITION OF THE SCIENTIFIC EFFORTS AND ADVANCES OVER 25 YEARS. >> I RETRACT MY PREVIOUS REMARKS. >> [LAUGHTER] >> BUT, WHAT ABOUT SMALL GROUPS? WHAT ABOUT OTHER INITIATIVES, MAYBE WE COULD DO MORE WORK OVER THE YEARS? BECAUSE I THINK ALL OF US WANT TO REALLY HELP? >> I WOULD LOVE TO HEAR DISCUSSION OF THAT. WHAT KINDS OF TOPICS ARE YOU INTERESTED IN, METRICS? >> ONE ASSESSMENT OF OUR PROGRAMS. >> OKAY, EVALUATION OF THE METRICS. >> YOU COULD HAVE A PROGRAM THAT WE WERE TALKING ABOUT BEFORE. >> YOU COULD HAVE A PROGRAM IT WOULD SEEM GOOD IF IT WOULD SEEM GOOD NOW IN THIS DAY AND AGE YOU HAVE TO DEMONSTRATE YOUR METRICS WITH SUCH TIGHT RESOURCES. SO, MAYBE A COMMITTEE ON HOW TO ASSESS METRICS OFLET [INDISCERNIBLE] OF ORPh, I DON'T KNOW IF IT'S A VAL YOU OR HAVE YOU IT. >> IT'S A VALUE OF INTEREST. OTHER TOPICS? CARMEN? >> SO I'D BE REMISS SINCE I'M DOING DOUBLE TWO WITH TWO MEETINGS TODAY TO NOT TALK ABOUT THE NATIONAL PAIN STRATEGY SO PEOPLE MAY NOT BE AWARE OF THAT BUT I CO CHAIROT ONE--THERE WILL BE A NATIONAL PAIN STRATEGY THAT WILL HOPEFULLY BE COMING OUT PRETTY SOON. AND THAT IS ACTUALLY SECRETARY KOE AND NOW, BUT BASICALLY THE OVERSIGHT COMMITTEE IS FINISHED PRETTY CLOSE TO BEING FINISHED. TELL BE MOVING TO HHS, HHS, THEY'VE SEEN SOME COPIES AND TELL GO THROUGH PUBLIC COMMENT AND AGENCY REVIEW PROCESS. SO I WAS FORTUNATE TO ONE SIT IN THE OVERSIGHT COMMITTEE AND TWO TO CO-CHAIR THE DISPARITIES REPORT. FOR THOSE WHO DON'T KNOW, THERE ARE SOME OF THESE WHO DO KNOW ABOUT PAIN. THERE'S DISCUSSION ABOUT HOW MANY PEOPLE ARE IN IT, BUT IT'S AT LEAST A HUNDRED MILLION PEOPLE THAT ARE--THAT LIVE WITH PAIN DISPROPORTIONATE,LY WOMEN IT DISPROPORTIONATELY AFACTS MINORITIES AND IT IS AN OPPORTUNITY FOR LEADERSHIP IN THIS ORGANIZATION AND I KNOW THERE ARE PEOPLE WHO ARE ON THE GROUND WHO ARE DOING THIS BUT IT MIGHT BE WORTH WHILE TO THINK ABOUT THAT. HOW--HOW SOMETHING TALKED ABOUT WITH AN HHS, AND THEN THE HEALTHY PEOPLE, 2020 GOAL. TALKING ABOUT PAIN AS A CHRONIC CONDITION, SO, YOU KNOW THAT MAY BE SOMETHING WE NEED TO THINK ABOUT AS WELL AS A TASK FORCE, BUT I WOULD SAY THAT'S A HUGE OPPORTUNITY PARTICULARLY AS IT GETS RELEASED AND WHAT THIS ORGANIZATION CAN DO AND HOW IT CAN LEVERAGE. >> THANK YOU FOR THAT SUGGESTION AND CHRONIC PAIN, PAIN IS JUST INCREDIBLE IMPORTANCE SO DEFINITELY ONE OF OUR PRIORITY AREAS SO THANK YOU FOR THE TIMING, I WASN'T REALIZING THE TIMING THERE. HOW ABOUT SEX SPECIFIC REPORTING? AND ANALYTERAL APPROACHES? --ANALYTICAL APPROACHES? I'M SEEING NODS, SO YOU'RE INTERESTED IN. >> TO CONTINUE THE WORK THAT TERESA WAS TALKING ABOUT APPROACHING EDITORS JOURNAL SO EVERYBODY AGREES. GREAT. OKAY. THANK YOU FOR THOSE SUGGESTIONS. >> OKAY, WE WOULD LIKE TO BRING AMY UP TO THE TABLE TO ADMINISTER OUR PUBLIC COMEBTS SECTION. >> WE GAVE SPECIFIC INSTRUCTIONS FOR ANYONE THAT WOULD LIKE TO SUBMIT WRITTEN COMMENTS IN REGARDS TO THE MEETING SO WE DID RECEIVE SEVERAL COMMENTS AND THEY WILL ALL BE ADDED TO THE PUBLIC RECORD, IF YOU WOULD LIKE TO SUBMIT COMMENTS AFTER THE MEETING FEEL FREE TO DO SO, THEY WILL ALSO BE ADDED TO THE PUBLIC RECORD. WE ALSO GAVE THE OPPORTUNITY FOR THOSE THAT WOULD LIKE TO COME AND PRESENT THEIR COMMENTS ORALLY TODAY TO DO SO. WE ALSO GAVE THEM SPECIFIC INSTRUCTIONS AND WE DO HAVE ONE PERSON HERE TODAY THAT WILL BE MAKING ORAL COMMENTS AND JUST A FEW GUIDELINES. PLEASE STATE YOUR NAME AND AFFILIATION BEFORE YOU BI BEGIN YOUR PRESENTATION. YOU WILL HAVE FIVE MINUTES TO SPEAK AND I WILL GIVE YOU A REMINDER AT THE FOUR MINUTE MARK THAT YOU HAVE ONE MINUTE LEFT. MARTHA? >> THANK YOU FOR THE OPPORTUNITY TO SPEAK TODAY, MY NAME IS MARTHA NOLAN AND I'M WITH THE SOCIETY FOR WOMEN'S RESEARCH WHICH IS THE ADVOCACY ORGANIZATION HERE IN WASHINGTON D. C. WHILE THERE ARE OTHERS THAT ADVOCATE FOR YOU WE ARE YOUR PRIMARY ONE AND WE WORK VERY HARD TO INSURE THIS OFFICE'S BUDGETS ARE THE FOCUS OF CONGRESS AND THEY ARE DEFENDED AND MAINTAINED AND THERE'S NOT ONLY THIS OFFICE BUT ALL THE OFFICES WITHIN THE FEDERAL AGENCIES WE SEEK TO DEFEND AND MADE PERMANENT IN THE AFFORDABLE CARE ACT. I HAVE CHANGES MY REMARKS SEVERAL TIMES TODAY DUE TO COMMENTS THAT WERE MADE AND IT'S BECAUSE I FEEL AS THOUGH THERE WERE SO MANY POINTS TO BE PICKED UP, THERE ARE--THE COMMENTS THAT I PROVIDED THAT PROVIDE A GREAT DEAL OF DETALE THEY FEEL I NO LONGER NEED TO GO INTO, WE ALSO PUBLISHED OUR COMMENTS TO NIH IN THE JOURNAL OF WOMEN'S HEALTH WITH OUR PERSPECTIVE OF THE FIVE POINTS THAT ARE SUBMITTED IN OUR PUBLIC COMMENTS FOR WHERE WE FEEL THE IMPLEMENTATION OF THE POLICY SHOULD GO. BUT THEY WERE--I WILL LEAP AHEAD MORE TO THE ADVOCACY AND THE PRESENTATION BY DR. WOODRUNFF AND HOW WE GOT TO WHERE WE ARE TODAY, AND MANY OF THOSE LONELY VOICES ON YOUR BEHALF, OVER THE LAST 25 YEARS, WE ARE ALSO CELEBRATING THAT NEXT YEAR AND ENDEAVORING TO TRY AND HAVE THE FOCUS ON BIOLOGICAL SEX DIFFERENCES, BE A PART OF ALL RESEARCH FROM PRECLINICAL TO CLINICAL AND IT'S BEEN VERY EXCITING OVER THE LAST, I WILL SAY FOUR YEARS TO SEE IF THINGS CHANGE AND TO FEEL AS THOUGH THEY'RE FINALLY, YOU'RE BEING HEARD, AND I KNOW--I VERY MUCH WANT TO THANK DR. CLAYTON FOR ALL HER WORK DONE HERE AT NIH AND THOSE AT FDA AND ELSEWHERE. THE EFFORT TO GET TO WHAT DR. BOLME PRESENTED TODAY START INDEED 2005 AND IN 1985 WITH THE RELEASE OF THE PHYSICIAN'S HEALTH STUDY REGARDING USE OF ASPIRIN AND ANYONE AT RISK OF HEART DISEASE AND THAT QUESTION IS NOT TRUE FOR WOMEN AND THEN IT TRIGGERED THE WHOLE REVOLUTION OF WHY AREN'T WOMEN BE STUDIED. SO THEN WE CAME TOGETHER TO PUSH CONGRESS TO GET THE FDA TO ENFORCE REGULATIONS REGARDING REPORTING AND ANALYSIS AND WASN'T UNTIL THE USER FEED BILL WE'RE ABLE TO LEAD THE ADVOCACY ORGANIZATIONS AS RECOGNIZED WE'RE ABLE TO PUT THAT INFORMATION AND PUT THAT LANGUAGE WITH OBVIOUSLY CONGRESS ASTERISKS MEMBERS TO ASK THE AGENCY TO TAKE THE STEPS THAT YOU HEARD ABOUT TODAY REGARDING THE REPORT AND THEN THE ACTION PLAN. I MEAN MOST IMPORTANT THING BESIDES THE FACT THAT THERE IS AN ANALYSIS OF SEX IS DONE, IS THE MAJOR GAPS DISPER PARITY AND MINORITY RESEARCH AS IS-- DISPARITY IN MINORITY RESEARCH, WHICH IT'S WITH THE DEMOGRAPHICS OF WHERE WE'RE HEADED AND WE NEED TO RESEARCH THAT. AND I WANT TO SAY THAT AMBIENN WAS A HUGE GAME CHANGER THEN LED TO 60S MINUTES SEE A GOOD STOUTERY TO TALK ABOUT FINALLY THAT IS BY THE FDA, I KNOW THEY WERE NOT THRILLED BY THE PRESENTATION BUT IT DIDN'T MAKE THIS LOOK GOOD AND THERE WAS A LOT OF STUFF THAT WENTOT CUTTING ROOM FLOOR BUT THE REALITY OF THAT HAS LED THIS TO WHERE IT IS AND IT'S PHENOMENAL AND EXCITING. AGAIN GOING BACK TO THE ROLE OF ADVOCACY--HOW AM I ON TIME? GEEZ. THE POINTS THAT WERE PRESENTED EARLY ARE BY JULIAN WERE VERY MUCH COME FROM THE ADVOCACY WORLD THAT I'M FROM WHICH IS THE COMMIT EYE REPORT LANGUAGE THAT COMES FROM ADVOCACY ORGANIZATIONS PUTTING THAT TO THE CONGRESSIONAL OFFICE TO ASK THOSE QUESTIONS TO GET THE DIALOGUE GOING, THE GAO REPORT, AGAIN CONVERSATIONS FROM ADVOCACY ORGANIZATIONS SUGGESTING WHAT THEY MIGHT WANT TO LOOK AT IN ORDER TO HAVE THE CONVERSATION WITH NIH. NIH CAN'T DO THAT ADVOCABULARY KASP A R O ITS OWN, NOT SAYING THEY'RE NOT TALKING TO BECAUSE THEY DO THEN TALK TO YOU BUT IT IS ALSO IMPORTANT THAT YOUR VOICES ARE MADE IN THAT PROCESS AND YOURS ARE JUST AS CRITICAL HAS MINE AND OTHERS IN WASHINGTON. RESEARCH FOR ALL, AGAIN CONVERSATION WITH MEMBERS OF CONGRESS. HOW THE ACT WILL CHANGE BEFORE IT'S REINTRODUCED NEXT YEAR BUT IT WILL BE REGREWSED THEY CARE, THEY'RE ASKING WHAT CAN THEY DO TO FORWARD THE GOOD WORK THAT YOU'RE ENDEAVORING TO DO. GAO WILL BE INTERESTING WHEN THEY DO MEET WITH YOU. HAY HAVE MET WITH US. SO I WILL TALK TO BUT THAT BUT IT WAS A PHENOMENAL AND FABULOUS CONVERSATION, THEY ARE LOOKING AT DETAIL AND WANT TO DO THE RIGHT THING IN ORDER TO ADVANCE THE WORKA WE ARE TRYING TO GET DONE. OH MY GOD I KOPT --I GOTTA KEEP GOING. I WILL GET TO PREGNANCY, THE OFFICE OF DIVISIONS AND HEALTH HELD A PHENOMENAL MEET NOTHING 2010, AND I DID NOT ATTEND, BUT I GOT AHOLD OF THE TRANSCRIPT. YES PREGNANT WOMEN GET SIX AND SIX WOMEN GET PREGNANT. WOMEN ARE BY THE HUMAN SUBJECT RESEARCH SUBJECT PROTEKDZ ACT AND ANOTHER LENS LENS LENS LENS LIABILITY ETHICAL REASONS ARE NOT ALLOWED TO BE IN TRIALS AND THERE'S ALL SORTS OF PROTOCOLS FOR INCLUDING US. I GRANT YOU THE REPRODUCTIVE YEARS ARE WELL PROTECTED AND THEY SHOULD NOT USE IT AS AN EXCUSE. THERE IS A MASSIVE EFFORT UNDER WAY BY DID. I. A. DRUG INFORMATION AUTHORITY TO PULL TOGETHER WORKING GROUPS TO TRY AND ADDRESS THIS CHALLENGE OF PREGNANT WOMEN. FDA, EMA ALL PART TELEVISION IS SHARING PART OF THEIR MEETING. I DON'T KNOW WHY NIH IS NOT THERE, SO I APOLOGIZE, I DON'T KNOW, CDC WAS RECENTLY PULLED IN AND WE WILL HAVE A MEETING WITH THEM IN OCTOBER. AND THERE'S THREE GREAT PAPERS WHICH I WILL SHARE WITH JEANINE THAT HAS BEEN PUBLISH FRIDAY THIS GROUP EFFORT WHICH PROVIDES A LANDSCAPE OF THE--I REALIZE I'M GOING OVER, BUT THIS IS THE BECAUSE I WANTED TO ANSWER THE QUESTIONS YOU WERE TALKING ABOUT IS THERE'S A PHENOL NAMEINAL CAPTURE OF THIS--PHENOMENAL CAPTURE OF THIS INFORMATION FOR THOSE WHO MIGHT BE OF INTEREST AND TO BE HONEST THE BIGGEST HURDLES ARE LEGAL AND ETHICAL. THANK YOU FOR THE OPPORTUNITY. >> THANK YOU MISS NOLL AN, I APPRECIATE YOUR--NOLAN, I APPRECIATE YOUR COMMENTS. OKAY, WELL. ALL RIGHTY SO BEFORE WE CLOSE THE MEETING, I WANT TO BE SURE WE'VE GIVEN ALL MEMBERS ANY OPPORTUNITIES ABOUT QUESTIONS OR THOUGHTINGS YOU MIGHT SHARE. OF COURSE YOUR ALWAYS ENCOURAGED TO SEND US REMARKS AT ANY TIME. WE WANT TO HEAR FROM YOU. WE VALUE YOUR INPUT AND THAT'S WHY YOU WERE SELECTED TO BE HERE. THIS IS DEFINITELY A TWO WAY CONVERSATION. SO I--WE WELCOME THAT. ANY LAST? OKAY. SO I WANT TO CLOSE THE MEETING BY ACKNOWLEDGING THE INCREDIBLE HARD WORK AND DEDICATION THAT WENT INTO PNG THIS MEETING. YOU ALL MAY NOT REALIZE IT BUT WE DID NOT HAVE CONTRACTOR SUPPORT FOR THIS MEETING. SO THIS MEETING WAS PLANNED AND EXECUTED WITHOUT CONTRACTOR SUPPORT BY THE INCREDIBLY DEDICATED AND HARD WORKING ORWH STAFF. I WANT TO RECOGNIZE THE DEPUTY OF THE COMMITTEE SUSAN MEYER, SO WOULDN'T BE HERE WITHOUT HER HARD WORK AND THEN MISS AMY FOR PLAN NOTHING THE OFFICE. AND MISS SHARON GIFT, KIM, SONIE, KA, AND MR. CHARLIE HEM WERE CRITICAL TO GETTING YOU HERE AND CRITICAL TO YOUR TRAVEL SO PLEASE TURN IN YOUR FORMS AND EVERYTHING YOU NEED TO DO THERE AS SOON AS POSSIBLE. AND WITHOUT THEM WE DEFINITELY WOULD NOT HAVE HAD THIS MEETING. SO, PLEASE JOIN ME? JUST THANKING THEM ONE MORE TIME. THIS WOULD NOT HAVE BEEN DONE WITHOUT THEM. [ APPLAUSE ] >> SO THANK YOU EVERYBODY AND DO WE NEED-- WE'RE GOING TO ANSWER ONE QUESTION BEFORE WE ADJOURN. >> THE REIMBURSEMENT FORMS WERE SENT TO YOU WITH ALL OF YOUR PRAFUL INFORMATION, WE WILL GO AHEAD AND SEND IT AGAIN TO MAKE SURE YOU HAVE IT, SO I APOLOGIZE, IF IT'S BURY ADDED BOTTOM OF THE BOX AND WE WILL RESEND THOSE FORMS. GET THEM IN AS SOON AS YOU CAN, WE PROCESS WITHIN FIVE DAYS. GOVERNMENT GUARANTEED. SNRVETION THANK YOUAL FOR YOUR KIND COMMENTS TODAY AND I'M LOOKING FORWARD TO WORKING TOGETHER AS WE MOVE FORWARD IN THIS NEW DIRECTION, THANK YOU VERY MUCH, WE'RE ADJOURNED. [ APPLAUSE ]