GOOD MORNING, EVERYONE, AND WELCOME TO THE 40TH MEETING OF THE NATIONAL INSTITUTES OF HEALTH ADVISORY COMMITTEE ON RESEARCH ON WOMEN'S HEALTH. WE'RE SO EXCITED TO SEE SO MANY OF YOU HERE. I'M JANINE CLAYTON, ASSOCIATE DIRECTOR FOR WOMEN'S HEALTH AND DIRECTOR OF THE OFFICE OF RESEARCH ON WOMEN'S HEALTH, AND WE HAVE A REALLY FUN, EXCITING, THOUGHT PROVOKING AGENDA TODAY, AND WE'RE CELEBRATING A SPECIAL DAY TODAY AS WELL. SO I'M REALLY LOOKING FORWARD TO ADVISORY COMMITTEE MEMBERS, YOUR VIGOROUS PARTICIPATION, AND OUR DISCUSSIONS TODAYED. I HAVE NO DOUBT WITH THE FOLKS AROUND THE TABLE THAT THAT WILL THE NOT BE A PROBLEM, AND WE'RE LOOKING FORWARD TO HAVING A GREAT DISCUSSION. AS WE GET STARTED, I NEED TO DO INTRODUCTIONS AROUND THE TABLE, BUT BEFORE I DO THAT, I'M GOING TO REVIEW OUR CONFIDENTIALITY AND CONFLICT OF INTEREST PROCEDURES. I NEED TO JUST READ THIS. IT IS NOW MY DUTY TO REA MIND YOU THE OF THE DEPARTMENTAL CONDUCT REGULATIONS PERTAINING TO SPECIAL GOVERNMENT EMPLOYEES. YOU EACH RECEIVED THESE WHEN YOU BEGAN YOUR TERM AND EACH YEAR YOU HAVE OR WILL RECEIVE A REMINDER. WE DO APPRECIATE YOUR EFFORTS TO KEEP US INFORMED OF ANY POTENTIAL CONFLICT OF INTEREST PRIOR TO EACH MEETING. LET ME ALSO REMIND YOU THAT ACCORDING TO FEDERAL LAW, COMMITTEE MEMBERS MAY NOT ENGAGE IN ANY LOBBYING ACTIVITIES WHILE ATTENDING COMMITTEE MEETINGS OR SPONSORED EVENTS. SO TODAY YOUR SGEs, SPECIAL GOVERNMENT EMPLOYEES, SO KEEP THAT IN MIND. SO I WILL CONTINUE WITH INTRODUCTIONS AROUND THE TABLE. IT'S MY PLEASURE TO WELCOME A NEW EXECUTIVE SECRETARY. >> HELLO, TERRI CORNELISON, ASSOCIATE DIRECTOR FOR CLINICAL RESEARCH IN THE OFFICE OF WOMEN'S HEALTH. IT IS MY ABSOLUTE PLEASURE TO BE HERE TODAY AMONGST ALL OF YOU, AND THANK YOU VERY MUCH FOR BEING HERE. >> SO YOU NEED TO USE YOUR MICROPHONE BECAUSE THERE ARE PEOPLE WATCHING THE VIDEOCAST. >> DIRECTOR OF NEUROSCIENCE INSTITUTES AT GEORGIA STATE UNIVERSITY, ALSO THE IMMEDIATE PAST PRESIDENT OF THE ORGANIZATION FOR THE STUDY OF SEX DIFFERENCES. >> GOOD MORNING. MY NAME IS ANGELA KASHUBA, CLINICAL PHARMACOLOGIST AND PROFESSOR AT THE UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL, AND I FOCUS ON HIV INFECTION AND WOMEN'S HEALTH ISSUES. >> I'M FROM TEXAS A & M, ASSOCIATE DEAN, MY RESEARCH ACTUALLY IS ON THE -- USE ON HUMAN BRAIN DEVELOPMENT AND PARTICULARLY FOCUSED ON THE FETAL ALCOHOL SYNDROME. >> HELLO. I'M DAVID PAIGE, AND ACTUALLY I WANTED TO THANK EVERYBODY FOR THE HONORARY DEGREE. I DON'T ACTUALLY HAVE A PH.D. [LAUGHTER] BUT IT'S VERY KIND OF YOU TO CONFER ONE. I MERELY HAVE AN M.D.MENT SO I'M PROFESSOR OF BIOLOGY AT MIT AND DIRECTOR OF THE WHITEHEAD INSTITUTE FOR BIOMEDICAL RESEARCH, AND I HAVE BEEN STUDYING THE GENETIC DIFFERENCES BETWEEN MALES AND FEMALES FOR A LONG TIME AND AM INTERESTED IN THE BROAD REACHING RAMIFICATIONS OF THAT. >> GOOD MORNING. I'M MARY PALMER, THE HELEN W. AND THOMAS DISTINGUISHED PROFESSOR ON AGING IN THE SCOOFL NURSING AT THE UNIVERSITY OF OF NORTH CAROLINA THE AT CHAPEL HILL. MY RESEARCH IS LOWER URINARY TRACT SYMPTOMS IN WOMEN AND THE GOAL IS TO ENHANCE BLADDER HEALTH ACROSS THE WOMAN'S LIFESPAN. >> GOOD MORNING. VALERIE MONTGOMERY RICE. I AM REPRODUCTIVE ENDOCRINOLOGIST AND FERTILITY PERSON. I AM THE PRESIDENT AND DEAN AT MOREHOUSE SCHOOL OF MEDICINE AND I HAVE A 40TH PIN ON BECAUSE WE, TOO, ARE CELEBRATING OUR 40TH ANNIVERSARY THIS YEAR, SO WE'RE EXCITED ABOUT THAT. MY RESEARCH FOE CAN CUSS IS ACROSS THE SPECTRUM OF A WOMAN'S LIFE LOOKING AT REPRODUCTIVE DISORDERS THAT IMPACT HER, BUT REALLY LOOKING AT ALSO SOME THE OF THE CHALLENGES WITH THE INEQUITIES THAT WE SEE AND TRYING TO MOVE US TOWARD HAVING IMPROVED OUTCOMES FOR ALL WOMEN. >> I'M JUDY REAGANSTEINER, PROFESSOR OF -- COLORADO SCHOOL OF MEDICINE. MY RESEARCH IS IN SEX DIFFERENCES IN THE CARDIOVASCULAR CONSEQUENCES IN TYPE 2 DIABETES. I'M THE DIRECTOR OF THE CENTER FOR WOMEN'S HEALTH RESEARCH, DIRECTOR OF THE OFFICE OF WOMEN AND MEDICINE IN SCIENCE, AND A BIRCH P.I., OF WHICH I'M EXTREMELY PROUD. >> I'M JILL BECKER, PROFESSOR OF PSYCHOLOGY AND MOLECULAR AND BEHAVIORAL NEUROSCIENCE AT THE UNIVERSITY OF OF MICHIGAN. MY RESEARCH STUDIES SEX DIFFERENCES AND MOTIVATION IN ANIMAL MODELS, SO I IT DO PRE-CLINICAL RESEARCH AND I'M CAST PRESIDENT OF THE ORGANIZATION FOR THE STUDY OF SEX DIFFERENCES. >> GOOD MORNING. I'M CARMEN GREEN, PROFESSOR OF ANESTHESIOLOGY, OBSTETRICS AND GYNECOLOGY AT THE UNIVERSITY OF MICHIGAN SCHOOLS OF ME MEDICINE AND PUBLIC HEALTH. I ALSO HAVE APPOINTMENTS IN OUR CENTERS THAT FOCUS ON RESEARCH ETHNICITY, CULTURAL HEALTH AND RESEARCH IN BLACK AMERICANS. MY RESEARCH REALLY FOCUSES ON CARE IT DISPARITIES AS IT RELATES TO AGE, RACE, GENDER AND CLASS ACROSS THE LIFESPAN, AND SO PAIN CARE DISPARITIES AND HEALTH POLICY. GLAD TO BE WITH YOU. >> I'M CONNIE WEAVER, HEAD OF NUTRITION SCIENCE AT PURDUE UNIVERSITY AND DIRECTOR OF THE WOMEN'S GLOBAL HEALTH INSTITUTE THERE. >> HI. I'M HEIDI NELSON, PROFESSOR OF MEDICINE, MEDICAL INFORMATICS AND CLINICAL EPIDEMIOLOGY AND MEDICINE AT ARE OREGON HEALTH SCIENCES UNIVERSITY AND ALSO MEDICAL DIRECTOR OF PROVIDENCE WOMEN AND CHILDREN'S PROGRAM. MY WORK FOCUSES ON EVIDENCE FOR PRACTICE GUIDELINES WITH THE PACIFIC NORTHWEST PRACTICE CENTER. >> I'M CAROLYN HSUE U.RI YALE UNIVERSITY, STUDYING A WIDE VARIETY OF CONDITIONS THAT ARE SUFFERED BY WOMEN AND WE FOCUS QUITE A BIT ON SEX DIFFERENCES AS WELL. AND WE'RE 18 YEARS OLD NOW AS THE CENTER STUDYING WOMEN'S HEALTH. >> I'M GERSON WEISS, RUTGERS NEW JERSEY MEDICAL SCHOOL FOR 30 YEARS, EMERITUS. MY WORK HAS BEEN IN PHYSIOLOGY OF HUMAN PRIMATES, PREGNANCY AND LABOR, AND MENOPAUSE. >> THANK YOU, EVERYONE. I WANT TO REMIND YOU THAT OUR COLLEAGUES ARE WATCHING US BY VIDEVIDEOCAST, AND THAT INCLUDES ONE OF OUR MEMBERS DR. TERESA WOODRUFF, SHE WANTED YOU TO KNOW SHE WAS STANDING BY AS CAN PARTICIPATE A LITTLE LATER. IT IS REALLY, REALLY FUN TO BE UP HERE TODAY TO SHARE WITH YOU ALL OF THE AMAZING THINGS THAT WE'VE BEEN DOING, BUT I WANT TO BEGIN RATHER THAN END MY REMARKS WITH AN ACKNOWLEDGMENT. I WANT TO ACKNOWLEDGE ALL OF THE ORWH STAFF WHO HAVE WORKED REALLY HARD THIS YEAR. WE HAVE BEEN UNDER CHALLENGING CIRCUMSTANCES AND MANY, MANY PEOPLE HAD TO STEP UP TO DO THINGS THAT WEREN'T PART OF THEIR POSITION, AND SO PLEASE JOIN ME IN CONGRATULATING ORWH STAFF FOR HELPING US TO GET TO WHERE WE ARE TODAY. [APPLAUSE] SO WE HAVE TWO NEW MEMBERS. YOU HEARD AROUND THE TABLE OUR ESTEEMED COLLEAGUES, BUT I WANT TO WELCOME OFFICIALLY TO THE ADVISORY COMMIT THE EE DR. CARMEN GREEN, WHO'S BEEN THE INAUGURAL ASSOCIATE VICE PRESIDENT AND ASSOCIATE DEAN FOR HEALTH EQUITY AND INCLUSION, AND YOU'VE HEARD ABOUT HER RESEARCH INTERESTS. WE ARE PARTICULARLY HOPING THAT HER EXPERTISE IN THE AREA OF PAIN MANAGEMENT WILL ASSIST THE COMMITTEE, I HAVE NO DOUBT THAT IT WILL. SHE HAS A VERY, VERY BROAD BACKGROUND, AND WE'RE DELIGHTED TO SELLER ON BOARD. HAVE HER ON BOARD AND SHE IS A NATIONAL ACADEMIES OF MEDICINE MEMBER. OUR SECOND NEW OFFICIAL MEMBER IS DR. CONNIE WEAVER, DISTINGUISHED PROFESSOR AND HEAD OF THE DEPARTMENT OF NUTRITION SCIENCE AT PURDUE, AND WE ARE EXCITED AS WELL TO HAVE ANOTHER NATIONAL ACADEMIES MEMBER ON BOARD AND LOOK FORWARD TO HER CONTRIBUTIONS IN THE AREA OF MINERAL BIOAVAILABILITY, CALCIUM METABOLISM AND BONE HEALTH, CRITICAL ASPECTS FOR THE HEALTH OF GIRLS AND WOMEN, SO WELCOME. AND MY DIRECTOR'S REPORT, I'M GOING TO BE ABLE TO TELL YOU ABOUT SOME THINGS THAT HAVE HAPPENED THIS YEAR THAT REALLY ARE NOT BASED ON WHAT WE IT DID THIS YEAR. THIS IS BASED ON WHAT MANY, MANY PEOPLE, WOMEN AND MEN HAVE DONE OVER TIME, OVER THE LAST 25 YEARS. SO WE WERE PLEASED THAT SENATOR MIKULSKI AND -- COLLINS PUT A RESOLUTION FORWARD IN THE SENATE AND THERE WAS A COMPANION RESOLUTION IN THE HOUSE CONGRATULATING ORWH AND NIH ON THE 25TH ANNIVERSARY OF THE OFFICE. REALLY, THE WAY I TOOK THE RESOLUTION, IT BEGINS WITH LOTS OF THINGS THAT WE DO, BUT IT ENDS WITH THINGS THAT THEY ENCOURAGE US TO CONTINUE TO DO. WHICH IS REALLY THE MOST IMPORTANT PART OF THE RESOLUTIONS THAT ARE BOTH AVAILABLE ONLINE, AND YOU CAN LINK FROM THEM TO OUR PAGE, SO I COURAGE YOU TO TAKE A LOOK AT WHAT THEY ARE ASKING NIH TO CONTINUE TO DO TO MAKE SURE THAT SEX AS A BIOLOGICAL VARIABLE IS CONSIDERED THROUGHOUT THE ENTIRE RESEARCH CONTINUUM, AND THAT THAT INFORMS WOMEN'S HEALTH. SO WE'RE REALLY, REALLY EXCITED ABOUT THIS DEVELOPMENT, AND WE'RE REALLY PLEASED AND HUMBLED BY THAT. WOMEN'S POLICY, INGE PUT O INC PUT ON AN EVENT IN HONOR OF OUR 25TH ANNIVERSARY SO WE WERE REALLY DELIGHTED TO BE THERE, AND WE HAD MANY, MANY MEMBERS OF CONGRESS SPEAK AND ATTEND. IT WAS AN INCREDIBLE EVENT. IT WILL BE AVAILABLE ONLINE IN THE FUTURE, BUT JUST SHARING WITH YOU A LITTLE BIT, AMBASSADOR CONNIE MORELLA, SENATOR MIKULSKI, OF COURSE, ORW STAFF ON THE RIGHT, AGAIN, REALLY DELIGHTED TO BE ABLE TO HEAR FROM SOME OF THE WOMEN WHO WERE THERE AT THE VERY BEGINNING AND ACTUALLY CAME TO NIH TO BASICALLY DEMAND THAT NIH ADDRESS THESE ISSUES OF INCLUSION OF WOMEN IN CLINICAL RESEARCH. CERTAINLY WITHOUT THEM, WE WOULD NOT BE WHERE WE ARE TODAY, AND IT'S REALLY HUMBLING TO BE ABLE TO RECOGNIZE THAT AND CONTINUE TO WORK ALONG THOSE LINES. SHIFTING GEARS A BIT, YOU KNOW THAT OUR FOCUS HAS BEEN ON THE DEVELOPMENT OF A NEW POLICY RELATED TO SEX AS A BIOLOGICAL VARIABLE, AND WE ANNOUNCED THAT IN A PUBLICATION THAT DR. COLLINS AND I PUT FORWARD OVER A YEAR AGO IN OUR ATTEMPT TO ADDRESS THE ISSUES OF SEX DIFFERENCES IN PRE-CLINICAL RESEARCH. AND IN DR. COLLINS' BLOG, HE POSTED THAT IT WAS NOT EASY WHEN WE TALKED AT THE VERY BEGINNING, 25 YEARS A TO GET WOMEN INCLUDED IN CLINICAL RESEARCH TOOK A CONCERTED EFFORT. NOW WOMEN ARE OVER 50%, WOMEN CONSTITUTE OVER 50% OF THE PARTICIPANTS IN NIH-SUPPORTED CLINICAL RESEARCH. BUT THAT'S TAKEN TIME AND EFFORT EFFORT. WE IT DID NOT HAV CAN DID NOT HAVE THE SAM E ATTENTION TO CLINICAL RESEARCH, AND WE KNOW SEX IS IMPORTANT IN THAT PRE-CLINICAL RESEARCH, THAT INFORMS OUR TRANSLATIONAL AND PRE-CLINICAL RESEARCH, SO WE ANNOUNCED WE WERE DEVELOPING A BALANCED APPROACH TO ADDRESSING MALE AND FEMALE DIFFERENCES IN CELLS AND ANIMALS. THESE THREE BULLETS HIGHLIGHT THE NIH MAJOR MISSION AREAS. I PUT THEM UP TO REMIND US OF WHY WE'RE HERE. WHY ARE WE AT THE NATIONAL INSTITUTES OF HEALTH, RATHER THAN PERHAPS ANOTHER AGENCY? THAT IS BECAUSE EVERYONE HERE IS COMMITTED TO IMPROVING HUMAN HEALTH. EVERYONE HERE, EVERY SINGLE STAFF EMPLOYEE AT THE NATIONAL INSTITUTES OF HEALTH, EVERY SINGLE GRANTEE ORGANIZATION IS COMMITTED TO IMPROVING HUMAN HEALTH. THAT'S WHY WE'RE HERE. WE NEED TO DO THAT BY EXPANDING OUR UNDERSTANDING OF FUNDAMENTAL BIOLOGY AND APPLYING THAT INFORMATION TO IMPROVE HEALTH. THAT TRANSLATIONAL PIECE IS A CRITICAL COMPONENT OF THE NIH MISSION, AND OF COURSE WE CANNOT DO THIS WITHOUT THE APPROPRIATE BIOMEDICAL WORKFORCE, AND THOSE ARE CRITICAL ISSUES FOR THE FUTURE. INHERENT AND INTRINSIC TO ACHIEVING ALL OF THESE IS ACKNOWLEDGING AND ACTING UPON THE FACT THAT SEX IS A FUNDAMENTAL BIOLOGICAL VARIABLE AND THAT NEEDS TO BE INCLUDED, AND THAT OUR APPROACH TO TURN DISCOVERY INTO HEALTH FOR HUMANS HAS TO INVOLVE STUDYING BOTH SEXES. IT JUST HAS TO INVOLVE THAT. I DID LEARN THAT POLICY IMPLEMENTATION IS DEFINITELY A TEAM SPORT, AND I DON'T KNOW HOW MANY PEOPLE ARE ON THE TEAM, I DON'T KNOW HOW MANY BACKUPS THERE ARE, I DON'T KNOW HOW MANY PEOPLE ON THE BENCH, BUT IT IS A TEAM SPORT, AND WE WELCOME EVERYONE TO THE TEAM. YOU DON'T HAVE TO TRY OUT TO GET ON THIS TEAM. IT INVOLVES ALL OF THE ENTITIES THAT PLAY A ROLE IN BIOMEDICINE. SO THAT'S SCIENTISTS, PROFESSIONAL SOCIETIES, SCIENTIFIC ORGANIZATIONS, INDUSTRY, THE MEDIA PLAY A HUGE ROLE IN GETTING THE PIECE OUT. THERE WAS INCREDIBLE ATTENTION TO THE "NATURE" PIECE THAT DR. COLLINS AND I PUT OUT. AACADEMIA, OUR JOURNAL COLLEAGUES, MEMBERS OF CONGRESS AND MANY, MANY OTHERS. AS WE SEEK TO MAKE A CHANGE AND TRANSFORM HEALTH SCIENCE IS DONE. WE NEED EVERYONE TO PLAY A PART IN THAT TRANSITION. SO THE ROAD TO POLICY, CONSIDERING SEX AS A BIOLOGICAL VARIABLE, I THOUGHT YOU WOULD APPRECIATE KIND OF SEEING A LITTLE BIT OF THE THINGS THAT HAVE BEEN GOING ON, SOME OF THESE BEHIND THE SCENES. SO A WHILE AGO, IRVING ZUCKER PUT OUT THIS PIECE IN "NATURE" HIGHLIGHTING THE FACT THAT MALES STILL DOMINATE ANIMAL STUDIES. INCREDIBLE MEDIA COVERAGE, THE LAY PRESS WAS EXTREMELY INTERESTED AND MOST OF THE CAN QUESTIONS I RECEIVED BEGAN WITH, WHAT DO YOU MEAN, YOU'RE NOT DOING THIS ALREADY? THERE WAS AN INCREDIBLE SURPRISE FROM MANY PEOPLE IN THE GENERAL PUBLIC THAT THIS WAS NOT STANDARD, TO CONSIDER SEX AS A BIOLOGICAL VARIABLE AND CONSIDER THAT THERE MAY BE MALE AND FEMALE DIFFERENCES IN PRE-CLINICAL RESEARCH. WE RELEASED A REQUEST FOR INFORMATION IN SEPTEMBER 2014 BECAUSE WE WANTED TO HEAR FROM THE COMMUNITY AND THE PUBLIC ABOUT THESE ISSUES. AND ALONG THE SAME LINE, AT THE SAME TIME, WE HAD CONSULTATION WITH MANY GOVERNING BODIES AT NIH, INCLUDING SCIENTIFIC DIRECTORS OF THE INTRAMURAL PROGRAM, A VARIETY OF OTHER GROUPS, REVIEW OFFICERS, PROGRAM OFFICIAL, MANY, MANY VISITS TO THESE DIFFERENT GROUPS TO DISCUSS AND GET INPUT AND FEEDBACK FROM THEM. OVER THAT SAME TIME, WE WERE CONSIDERING FORM CHANGES AND WE PUBLISHED A GUIDE LETTING PEOPLE KNOW WHAT OUR INTENTIONS WERE. WE ALSO AT THE SAME TIME OF DEVELOPING THE POLICY HAVE BEEN DEVELOPING BASELINE ISSUE, DEVELOPING STAFF AND REVIEWER TRAINING, AND THINKING ABOUT THE BEST WAY TO IMPLEMENT THIS THROUGH PEER REVIEW. AND SO IN JUNE 2015, THERE WERE TWO COMPANION GUIDE NOTICES THAT WENT OUT. THE FIRST IS A PART OF A LARGER NIH EFFORT ENHANCING REPRODUCIBILITY THROUGH RIGOR AND TRANSPARENCY. HERE WE'RE REVISING INSTRUCTIONS AS WELL AS EXISTING REVIEW CRITERIA TO ENHANCE REPRODUCIBILITY THROUGH RIGOR AND TRANSPARENCY. THERE ARE FOUR COMPONENTS TO THAT INITIATIVE. THE FIRST IS A SCIENTIFIC PREMISE OF THE PROPOSED RESEARCH, THE SECOND IS RIGOROUS EXPERIMENTAL DESIGN, AND THE THIRD IS CONSIDERATION OF SEX AND OTHER RELEVANT BIOLOGICAL VARIABLES, AND KEY CHEMICAL OR BIOLOGICAL RESOURCES. THIS WAS THE LEAD-IN TO THE GUIDE NOTICE ENTITLED CONSIDERATION OF SEX AS A BIOLOGICAL VARIABLE IN NIH-FUNDED RESEARCH, WHERE WE ANNOUNCED OUR INTENTIONS REGARDING THE POLICY. SO JUST OCTOBER 9TH, THIS ADDITIONAL GUIDE NOTICE WENT OUT. I'M NOT SURE EVERYONE HAD A CHANCE TO SEE THIS, TALKING ABOUT THE WAYS THAT WE WILL BE IMPLEMENTING THESE RIGOR AND TRANSPARENCY INITIATIVES. AND HERE, I HIGHLIGHT JUST THE PIECES RELEVANT TO SEX AS A BIOLOGICAL VARIABLE OR SABV, AS WE CALL IT. IN THE RESEARCH STRATEGY SECTION, APPLICANTS MUST EXPLAIN HOW RELEVANT BIOLOGICAL VARIABLES SUCH AS SEX ARE FACTORED INTO THE RESEARCH DESIGN AND ANALYSES FOR STUDIES IN VERTEBRA ANIMALS AND HUMANS. STRONG INDICATION FROM THE SCIENTIFIC LITERATURE, PRELIMINARY DATA OR OTHER RELEVANT CONSIDERATIONS MUST BE PROVIDED FOR APPLICANTS THAT ARE SEEKING TO STU CAN DI ONLY ONE SEX. SO THE DEFAULT IS TO STUDY BOTH SEXES IN JUSTIFICATION FOR NOT DOING THAT HAS TO BE PROVIDED. IN TURN, REVIEWERS ARE GOING TO ASK, HAVE THE INVESTIGATORS PRESENTED ADEQUATE PLANS TO IT ADDRESS RELEVANT BIOLOGICAL VARIABLES SUCH AS SEX OR STUDIES INVERTEBRATE ANIMALS AND HUMAN SUBJECTS. THIS GOES INTO EFFECT FOR RESEARCH GRANTS AND CAREER AWARD APPLICATIONS THAT ARE DUE JANUARY 25TH, 2016, AND BEYOND. THE TIMELINE FOR IMPLEMENTATION OF THE POLICY IS SHOWN ON THIS SLIDE. FAQs, NEW FAQs WENT OUT ON OCTOBER 14TH, AND I ENCOURAGE YOU TO TAKE A LOOK AT THOSE. THEY ARE AVAILABLE ON THE OER WEBSITE AND LINKS FROM THE ORH WEBSITE RELEVANT TO THE SABV FAQs. I INTERNAL TRAINING HAS BEEN DEVELOPED AND RELEASED AND WE EXPECT BY NOVEMBER 25TH TO HAVE UPDATED APPLICATION INSTRUCTIONS AND NEW FOAs TO INCLUDE THIS INFORMATION. IN JANUARY, AS I MENTIONED, FIRST RESEARCH AND CAREER DEVELOPMENT APPLICATIONS FOR FY17 IT FUNDIN17 FUNDING ARE DUE, AND THEY WILL BE SUBJECT TO THE NEW POLICY. IN MAY OF 2016, THE FIRST FELLOWSHIP AND TRAINING GRANT APPLICATIONS ARE DUE, AGAIN SUBJECT TO THE POLICY WITH SOME DIFFERENCES. THEN SPRING OF THIS YEAR COMING UP, WE'LL HAVE THE FIRST ROUND OF SCIENTIFIC REVIEW WITH THE FIRST AWARDS IN FALL OF 2016 AND FOR FY17. AS WE THINK ABOUT WHAT WOMEN'S HEALTH RESEARCH IS IN 2015, AND WE ARE CELEBRATING OUR 25TH ANNIVERSARY, I KIND OF GLIBLY SAID THAT AT 25, YOU THINK YOU CAN DO ANYTHING AND IT'S KIND OF STUCK WITH ME BECAUSE YOU REALLY DO THINK YOU CAN DO ANYTHING AT IT 25. SOME OF US STILL THINK WE CAN DO ANYTHING WHEN WE'RE NOT 25 BUT CLEARLY AT 25, YOU STILL THINK YOU CAN DO ANYTHING WITH LOTS AND LOTS OF WORK TO DO. BUT YOU WANTED TO JUST RECOGNIZE THE INCREDIBLE HISTORY OF THIS OFFICE AND THE AMAZING WOMEN AND MEN WHO CAME BEFORE. FIRST ON THE LEFT IS DR. RUTH PERSTENI, IN THE MIDDLE YOU HAVE SENATOR MIKULSKI AND DR. BERN DEAL HEELY, THE FIRST FEMALE NIH DIRECTOR, FIRST AND ONLY, AND DR. VIVIAN TIMM, THE FIRST FULL TIME DIRECTOR OF THE OFFICE OF RESEARCH ON WOMEN'S HET. THESE WOMEN ASKED QUESTIONS AND MADE SURE THESE ISSUES WERE ATTENDED TO. THAT'S A LOT ABOUT WHAT SCIENTISTS DO. THERE'S SOME CITIZEN SCIENTISTS, SOME POLITICIAN SCIENTISTS, BUT THESE WOMEN ASKED QUESTIONS. WHY ARE YOU DOING THINGS THIS WAY, WHY AREN'T YOU DOING THIS THIS WAY, HOW ARE YOU ADDRESSING THIS? SO I JUST WANTED TO RECOGNIZE THEM, AND ALSO TO TALK ABOUT THE FACT THAT DR. HEELY, ON HER WATCH, IT WAS THE WOMEN'S HEALTH INITIATIVE THAT WAS LAUNCHED, WHICH WAS UNPRECEDENTED COMMITMENT OF FUNDS TO AN AREA THAT WAS SPECIFIC TO WOMEN. AND THE WAY I THINK ABOUT THE WHI IS THAT IT ANSWERED QUESTIONS THAT WE THOUGHT WE KNEW THE ANSWERS TO. BUT WE HADN'T ASKED THEM RIGOROUSLY. SO MENOPAUSAL HORMONE THERAPY, WE THOUGHT WE KNEW WHAT IT WOULD DO, AND CLEARLY WE STILL HAVE A LOT TO LEARN IN THAT AREA, BUT YOU NEED EFFORTS LIKE THAT WHEN THERE IS A SCIENTIFIC OR PUBLIC HEALTH OR BIOMEDICAL ISSUE THAT NEEDS TO BE ADDRESSED FOR A SINGLE SEX, YOU NEED TO HAVE ACTIVITIES LIKE THE WHI WHICH CONTINUES TO BEAR FRUIT. IT REALLY IS AN AMAZING EXAMPLE OF A SMART INVESTMENT AND SMART SCIENCE. SO IN 1993, NIH HAD A MANDATE TO INCLUDE WOMEN AND MINORITY GROUPS IN CLINICAL RESEARCH. THERE'S ACTUALLY A LAW THAT REQUIRES THAT. AND THEN 2015, THE WAY WE THINK OF AN ORWH IS AS A FOCAL POINT FOR RESEARCH ON SEX AND GENDER INFLUENCES ON HEALTH, BECAUSE WE KNOW THAT BOTH SEX -- BEING BIOLOGICALLY MALE OR FEMALE AND GENDER, SOCIAL, CULTURAL AND OTHER DOMAINS RELATED TO SEX HAVE LOTS OF INFLUENCES ON HUMAN HEALTH. SOMETIMES THERE ARE DIFFERENCES AND SOMETIMES THERE ARE NOT. SOMETIMES THERE ARE NUANCE, SOMETIMES THEY'RE OBVIOUS, BUT IT'S VERY, VERY COMPLICATED A RENA, BUT WE KNOW THAT THAT IS A VARIABLE, THOSE ARE VARIABLES THAT CLEARLY AFFECT HEALTH. SO TODAY, WE THINK OF WOMEN'S HEALTH AS EVERYTHING THAT AFFECTS A WOMAN FROM HEAD TO TOE. SO I LIKE TO THINK ABOUT THAT AS THE HEALTH OF WOMEN. THAT INCLUDES REPRODUCTIVE ISSUES, THAT INCLUDES THE FACT THAT REPRODUCTIVE ISSUES AFFECT OUR LATER HEALTH, FOR EXAMPLE, PREECLAMPSIA INCREASES THE RISK FOR SUBSEQUENT STROKE. THAT ALSO INCLUDES UNDERSTANDING HOW WOMEN AND MEN MAY DIFFER OR MAY BE SIMILAR IN CERTAIN CIRCUMSTANCES, AND WHEN HE STRESSORS OR TRIGGERS OR INFECTIONS OR OTHER ILLNESSES MAY UNMASK DIFFERENCES THAT ARE CLINICALLY IMPORTANT. SO FROM OUR PERSPECTIVE, WE WANT TO UNDERSTAND WHAT IS SCIENTIFICALLY IMPORTANT ABOUT SEX AS A BIOLOGICAL VARIABLE IN PRE-CLINICAL RESEARCH SO THAT WE CAN TRANSLATE THAT INTO WHAT IS CLINICALLY IMPORTANT FOR MEN AND WOMEN AND WOMEN'S HEALTH. ALONG THOSE LINES, VERY RECENTLY WE SPONSORED A MEETING AT THE NATIONAL ACADEMY OF SCIENCES ENTITLED RAISING THE BAR, THE HEALTH OF WOMEN IN AMERICA. AND IN THIS MEETING, VERY RECENTLY, WE IDENTIFIED KEY FACTORS THAT MIGHT EXPLAIN THE COMPARATIVE DEFICIENCY IN THE HEALTH OF U.S. WOMEN. THIS REPORT ON THE LEFT CALLED SHORTER LIVES -- PUT OUT SOME TIME AGO ILLUSTRATED THAT COMPARED TO 16 PEER COUNTRIES, ILLUSTRATED THAT COMPARED TO 16 PEER COUNTRIES, THE UNITED STATES HEALTH DATA WAS UNIFORMLY AT THE BOTTOM. EXCEPT FOR ONE INDICATOR, WHERE WE WERE NUMBER ONE. AND WE WERE NUMBER ONE IN THE COST AND THE AMOUNT OF MONEY THAT WE SPEND ON HEALTHCARE AND MATERNAL MORTALITY AND MORBIDITY, ACCIDENT, TRAUMA, EVERYTHING ELSE WERE EITHER 16 OR 17 OR AT THE BOTTOM. AND WHEN YOU PARSE THAT OUT AND LOOK TH AT MALE/FEMALE DIFFERENCE, WE ALSO LOOK AT THE DIFFERENCE BETWEEN WOMEN IN THE UNITED STATES AND WOMEN IN PEER COUNTRIES AND WE ARE NOT DOING VERY WELL. WE WERE VERY CONCERNED ABOUT THAT. I WAS ABLE TO PARTICIPATE IN A BRIEFING ON THE HILLARY LATED TO THAT TRYING TO BRING ATTENTION TO THIS ISSUE, SO WE DEVELOPED THE RAISING THE BAR MEETING TO TRY TO DIVE DEEPER INTO WHAT'S GOING ON IN THE HEALTH OF WOMEN IN THE UNITED STATES. HERE IN THIS MEETING, WE IDENTIFY AND PRIORITIZE RESEARCH GAPS, TO DECREASE MORTALITY AND MORBIDITY, AND WE WANTED TO LOOK SPECIFICALLY FOR AREAS WHERE SMALL INTERVENTION OR A FOCUSED INTERVENTION COULD HAVE A LARGE IMPACT. I ENCOURAGE YOU TO STAY TUNED FOR THE REPORT AND THE SUMMARY OF THAT MEETING, WHICH WILL BE PUBLISHED IN DECEMBER OF THIS YEAR, AND I WILL DEFINITELY BE CALLING ON ADVISORY COMMITTEE MEMBERS TO WEIGH IN ON THAT. THIS IS THE GRAPH THAT I WANTED TO JUST -- I ONLY WANTED TO SHOW ONE PIECE OF DATA FROM THIS SET OF DATA THAT WAS HAPPENING OVER THE LAST COUPLE OF YEARS DEMONSTRATING THE PROBABILITY OF SURVIVAL TO AGE 50. JUST 50, IN 21 HIGH INCOME COUNTRIES. UNITED STATES IS REPRESENTED BY THESE HIGH DOTS. SO MALES OVER HERE, FEMALES OVER HERE, TIME IS HERE. SO OVER TIME, WE'RE HE D AT THE BOTTOM FOR MALES. I JUST TOLD YOU THAT THAT'S AN ISSUE. OVER TIME WE'RE AT THE BOTTOM, AND HERE AROUND WOULD THOU, WE'RE FALLING OFF OF THE CHART. WE'RE OFF OF THE CHART. THERE'S SOMETHING GOING ON THERE. AND I HAVE TO SAY, AS A WOMAN, AS A MOTHER, AS A DAUGHTER, AND I WOULD THINK ALL THE MEN IN THIS AUDIENCE WOULD BE VERY CONCERNED ABOUT WHAT IS HAPPENING THERE. IN A COUNTRY WHERE WE HAVE INCREDIBLE RESEARCH INVESTMENTS, THERE IS NO REASON WHY WE SHOULDN'T UNDERSTAND WHAT'S GOING ON THERE SO THAT WE CAN DO SOMETHING ABOUT IT. SHIFTING GEARS AGAIN, I'M GOING TO SWITCH OVER TO TELLING YOU A LITTLE ABOUT HOW WE HAVE BEEN OPERATING THIS YEAR AND DESCRIBING SOME OF OUR RESEARCH PROGRAMS, SO THIS PIE CHART SHOWS OUR FUNDING BY PROGRAM. I WANTED TO SHARE WITH YOU OUR SPECIALIZED CENTERS ON SEX DIFFERENCES RESEARCH, OUR SCORE SCORES, WHICH YOU'LL HEAR ABOUT FROM DR. MILLILITERRER I MILLER IN A LITTL E BIT. WE INSTITUTED AN R56 PROGRAM LAST YEAR TO PROVIDE BRIDGE FUNDING FOR APPLICATIONS AND THAT'S HERE, AND OTHER CO-FUNDS OR GRANTS THAT WITH WE CO-FUND WITH AN INSTITUTE OR CENTER COMES TO US AND IDENTIFIES AN APPLICATION THAT MEETS SOME OF THE STRATEGIC PLAN GOALS OR OBJECTIVES FROM THE NIH-WIDE STRATEGIC PLAN FOR WOMEN'S RESEARCH, WE CONSIDER THOSE THROUGH A SYSTEMATIC PROCESS, AND THOSE ARE CA CONSIDERED OTHER FUNDS. WHAT I CHOSE TO TALK ABOUT TODAY IS OUR ADMINISTRATIVE SUPPLEMENTS FOR SEX DIFFERENCES RESEARCH PROGRAM. WE ARE IN YEAR THREE OF THAT PROGRAM, AND I HAVE TO SAY, IT'S BEEN AN EXCITING AND I THINK INSTRUMENTAL IN GETTING SOME OF OUR COLLEAGUES TO THINK ABOUT SEX AS A BIOLOGICAL VARIABLE, BECAUSE CLEARLY, PEOPLE FOLLOW THE MONEY. AND WHAT YOU CAN SEE HERE IS THAT THIS IS A BREAKDOWN OVER ADMINISTRATIVE SUPPLEMENTS FUNDING FOR FY15 BY INSTITUTES OR CENTER. THERE ARE A FEW INSTITUTES THAT HAVE FEWER FOLKS PUT FORWARD THESE APPLICATIONS AND THEY'RE REVIEWED ADMINISTRATIVELY, AND WE'RE REALLY EXCITED AND THRILL WOULANDTHRILLED TO HAVE SPENT OVER $7 MILLION ON THESE AWARDS THIS YEAR. I'M REALLY LOOKING FORWARD TO SEE THE SCIENTIFIC ADVANCES THAT COME OUT OF THESE SUPPLEMENTS. THESE ARE STUDIES THAT WE'RE NOT PLANNING TWERE NOTPLANNING TO LOOK AT DATA DISAGGREGATED BY SEX, PER SE. HERE IS THE BREAKDOWN IN TERMS OF PERCENTAGE OF THE APPROACH THAT THESE FY15 SUPPLEMENTS TOOK. SO YOU CAN SEE THE HIGHEST IS ADDING A NEW SEX TO SINGLE SEX RESEARCH. THAT CONSTITUTES MOST OF THESE SUPPLEMENTS. SO THAT TELLS YOU WHAT WAS HAPPENING BEFORE. ADDING SUBJECTS TO EXISTING STUDIES TO INCREASE POWER AND ANALYZING EXISTING SAMPLES OR DATASETS AND THEN SINGLE SEX RESEARCH THAT WAS JUSTIFIED IS THE LOWEST. SO WE'RE REALLY LOOKING FORWARD TO SEEING THE RESULTS OF THOSE SUPPLEMENTS. THE VAST MAJORITY ALSO PROPOSED PRE-CLINICAL RESEARCH, AND WE INDICATED IN OUR FUNDING OPPORTUNITY ANNOUNCEMENT THAT WE WERE FOCUSING ON PRE-CLINICAL RESEARCH SO WE WERE EXCITED TO BE ABLE TO SEE THE BASIC SCIENCE COMMUNITY COME OUT AND APPLY. HERE ARE SOME OF THE EXAMPLES FROM THIS YEAR'S FY15 ADMINISTRATIVE SUPPLEMENTS. I JUST PULLED A FEW TO SHOW YOU THE RANGE OF THE SCIENCE BEING PERFORMED IN THESE ADMINISTRATIVE SUPPLEMENTS. YOU CAN SEE FROM NIAMS' TOPIC, THE ROLE OF NOTCH SIGNALING IN OSTEOCYTES, SEX DIFFERENCES IN CANNABINOID REGULATION OF ENERGY HOMEOSTASIS, THEY'R, MECHANISMS UNDERLYING PERSISTENT LENT VIRUS REPLICATION IN FOLLICULAR T CELLS, SO LOOKING FOR SEX DIFFERENCES IN C IT TLA-4 EXPRESSION IN THESE TFR-MODULATED HIV REPLICATION. YOU CAN SEE THERE'S A SUPPLEMENT FROM NIGMS WHICH IS EXTREMELY BASIC, THEN FROM NINDS, REGULATORY CONTROL OF GLUTAMATE-INDUCED SUPEROXIDE PRODUCTION, ADDING FEMALE CELLS AND FEMALE MICE TO FURTHER INVESTIGATE ME CA MECHANISMS OF BRAIN INJURY RESULTING FROM STROKE. WE WERE ALSO VERY, VERY HEARTENED TO HEAR THAT THE COMMON FUND DECIDED TO OFFER ADMINISTRATIVE SUPPLEMENTS FOR SEX DIFFERENCES RESEARCH AS WELL, AND THESE ARE THE PROGRAMS IN THE COMMON FUND THAT HAVE SUPPLEMENTS. THE GENOTYPE TISSUE EXPRESSION, HUMAN HEALTH AND HEREDITY IN AFRICA, HIGH RISK, HIGH REWARD, METABOLOMICS, ALL HAVE SUPPLEMENTS LOOKING AT SEX DIFFERENCES. AND I'M SURE IN OUR PANEL THIS AFTERNOON, SOME OF THESE APPROACHES MAY COME UP BUT I JUST WANTED TO SHARE THIS NEWS WITH YOU. SO AS WE HAVE BEEN TALKING ABOUT CONSIDER BEING SEX AS A BIOLOGICAL VARIABLE, SPEAKING ABOUT IT BOTH INTERNALLY AND EXTERNALLY, WE OFTEN GET ASKED, HOW DO I JUST GET STARTED, I DON'T KNOW WHAT TO DO, WHERE CAN I START. SO WE PROVIDE THIS REALLY STRAIGHTFORWARD SUGGESTIONS FOR FOLKS, RECOGNIZING THAT THE WAY TO FACTOR SEX AS A BIOLOGICAL VARIABLE INTO A PARTICULAR SCIENTIFIC PROJECT IS DEPENDENT ON THE CONTEXT, THE RESEARCH QUESTION, WHAT'S KNOWN, AND MANY, MANY OTHER FACTORS. SO THESE ARE GENERAL. ADDING SEX GENDER MALE/FEMALE TERM ITS, ACKNOWLEDGING SEX SKEW DISEASE THAT MAY UNDERLINE SEX OR GENDER-BASED DIFFERENCES, BUT I WANT TO CAUTION THERE AND ADD THAT JUST BECAUSE THERE MAY NOT BE A DIFFERENCE IN INCIDENCE OR PREVALENCE BY SEX FOR A DISEASE, SO LUPUS WOULD BE AN EXAMPLE WHERE IT'S EXTREME AND WELL RECOGNIZED THAT IT'S MUCH MORE COMMON IN WOMEN THAN MEN, THAT DOESN'T MEAN THAT THE MECHANISMS UNDERLYING DISEASE PROGRESSION, DISEASE MANIFESTATION OR RESPONSE TO TREATMENT ARE SIMILAR. SO SIMILAR PROPORTIONS OF AFFECTED INDIVIDUALS DOESN'T MEAN THAT THERE ISN'T A CLINICALLY RELEVANT INFLUENCE OF SEX IN THAT SITUATION. FOR EXAMPLE, LUPUS IS MORE SEVERE IN ONE SEX IN A SPECIFIC CIRCUMSTANCE, AND SO YOU NEED TO KNOW THAT AS YOU'RE DEVELOPING ANIMAL MODELS TO STUDY THOSE DISEASES. INCLUDING BOTH MALES AND FEMALES, PRETTY STRAIGHTFORWARD DESIGN ISSUES ARE PUT FORWARD, BUT I THINK THE MOST STRAIGHTFORWARD ONE IS ASKING PEOPLE TO REPORT SEX-BASED DATA. AND ANY IDENTIFIED SEX-BASED INFLUENCES. SO COLLECTING YOUR DATA DISAGGREGATED BY SEX AS APPROPRIATE AND REPORTING YOUR DATA DISAGGREGATED BY SEX, STATISTICS FOR MALE, SEPARATE FROM FEMALES, COULD GO A LONG WAY IN PROVIDING MORE INFORMATION ABOUT THE SEX-SPECIFIC KNOWLEDGE BASE THAT WOULD BE HELPFUL TO EVERYONE. I WANT TO ALSO SHARE WITH YOU A RECENT WORKSHOP THAT WAS PUT ON BY ILAR. THE TITLE IS THE MISSING R, REPRODUCIBILITY IN A CHANGING RESEARCH LANDSCAPE. MICHAEL FESTING SAYS MOST FALSE POSITIVE RESULTS ARE DUE TO FAULTY EXPERIMENTAL DESIGN AND INCORRECT ANALYSIS AND THAT RESEARCHERS SHOULD BE DELIBERATELY INSERTING SEX AND STRAIN DIFFERENCES INTO THEIR EXPERIMENTAL SAMPLE POOLS. THIS REPORT IS AVAILABLE ONLINE, AND THERE ARE A VARIETY OF INDIVIDUALS LIKE MICHAEL FESTING, MANY, MANY OTHERS, WHO HAVE PUT FORWARD IDEAS AND TIPS ABOUT HOW TO DO THIS. HERE ARE SOME OF THE SCIENTIFIC RESOURCES THAT ARE AVAILABLE RELATED TO STUDYING BOTH SEXES. THEY RANGE FROM THE 4-CORE GENOTYPE MODEL, I SEE DR. ARNOLD IS HERE, TO KNOCKOUT MODEL TO DEPLETION MODELS, TO DESIGN APPROACHES. THERE ARE A WIDE VARIETY OF TOOLS AND STRATEGIES AVAILABLE. WE ARE CONFIDENT HA INVESTIGATORS WHO ARE BRILLIANT WILL DEVELOP THE APPROPRIATE APPROACHES TO FACTOR SEX AS A BIOLOGICAL VARIABLE INTO THEIR RESEARCH OVER TIME. SO YOU CAN ACCESS ALL OF THIS INFORMATION ONLINE AT THE ORWH WEBSITE MPLE THE PAGE FOR THAT IS STUDYING SEX TO STRENGTHEN SCIENCE OR S4. THE WORKSHOP WE HAD LAST YEAR, THE SLIDES ARE THERE, INTERVIEWS ARE THERE, MATERIAL IS THERE. THE ONLINE COURSE THAT WE CO-SPONSOR WITH THE FOOD AND DRUG ADMINISTRATION ON THE SCIENCE OF SEX AND GENDER IN HUMAN HEALTH, A READING ROOM THAT HAS ARTICLES, OTHER RESOURCES AND MATERIALS ARE AVAILABLE ON OUR WEBSITE. SO I JUST WANT TO END BY SAYING THAT IT'S BEEN A WHIRLWIND YEAR, BUT IT IS ACTUALLY ONLY THE BEGINNING OF IMPLEMENTING A POLICY OF DEVELOPING A NEW WAY OF THINKING ABOUT SEX AS A BIOLOGICAL VARIABLE. SO WE'VE BEEN TALKING ABOUT POLICY, WHICH IS IMPORTANT BECAUSE WITHOUT THE POLICY, THESE THINGS WERE NOT HAPPENING. THE POLICY WAS NECESSARY BECAUSE THE ISSUES WEREN'T BEING ADDRESSED, AND THAT COULD HAVE BEEN ADDRESSED THROUGH THE SCIENTIFIC COMMUNITY. SO NOW THAT WE HAVE A POLICY, REALLY, IT IS OUR SCIENTIFIC COLLEAGUES AND OUR ACADEMIC COLLEAGUES AND PROFESSIONAL SOCIETIES AND OTHERS AS WELL AS JOURNAL EDITORS WHO CAN PLAY THE ROLE IN IMPLEMENTING WHAT IS BEHIND POLICIES. BECAUSE REALLY WHAT WE'RE TRYING TO DO IS TO TRANSFORM HOW SCIENCE IS DONE SO THAT 10 YEARS FROM NOW, WHEN WE'RE 35, WE CAN SAY THAT IT'S ROUTINE THAT SEX AS A BIOLOGICAL VARIABLE IS CONSIDERED FROM THE BEGINNING, THAT WHEN SOMEONE DEVELOPS A RESEARCH QUESTION, THEY AUTOMATICALLY THINK WILL THIS BE DIFFERENT FOR MALES OR FEMALES, HOW MIGHT IT INFLUENCE IT, SHOULD I SELECT JUVENILE ANIMALS OR SENESCENT ANIMALS FOR THIS BECAUSE I UNDERSTAND CAN -- WHATEVER, THAT THAT WILL BE ROUTINE. AND SO WE WON'T HAVE THIS DISCUSSION, I'M SURE WE'LL HAVE SOME OTHER DISCUSSIONS THAT WILL BE JUST AS EXCITING, AND IN THE END, I WANT TO JUST HIGHLIGHT THAT THROUGH DOING THIS, WE REALLY ARE GOING TO TRIGGER DISCOVERIES. WE'RE GOING TO LEARN MORE, AND WE ABSOLUTELY, IN 2015, HAVE TO MAKE EVERY RESEARCH DOLLAR COUNT. IT'S VERY TIGHT FOR EVERYONE. SO WE HAVE TO LEARN THE MOST WE CAN FROM EVERY DOLLAR WE SPEND, EVERY EXPERIMENT WE DO, AND WE HAVE TO SHARE THAT INFORMATION, BECAUSE THIS IS TAXPAYER FUNDED RESEARCH, AND THAT INFORMATION NEEDS TO BE AVAILABLE. THANK YOU SO MUCH FOR YOUR ATTENTION. [APPLAUSE] >> OKAY. SO WE HAVE TIME FOR QUESTIONS BEFORE OUR NEXT PRESENTATION, RIGHT? ARE YOU TRYING TO MAKE A COMMENT? >> NO, BUT I CAN MAKE ONE. >> OKAY, YOU'RE GOING TO MAKE A COMMENT. >> I ACCIDENTALLY TURNED THIS ON. SO IN YOUR PRESENTATION, I WAS WONDERING THAT YOU GET PUSHBACK FROM SCIENTIST, CLINICAL AND BASIC SCIENTISTS, ABOUT RAISING THE COST OF THE EXPERIMENTATION BY ADDING MALES AND FEMALES TO ACTUALLY FIND A SEX DIFFERENCE IF THERE IS ONE. I THINK ONE IMPORTANT POINT TO BE MADE IS THAT YOU DON'T REALLY HAVE TO WORRY TOO MUCH ABOUT IT, TO MIX YOUR EXPERIMENTAL GROUPS, EQUAL AMOUNTS OF MALES AND FEMALES, RELATIVELY EQUAL NUMBERS OF MALES AND FEMALES. IN MOST CASES, IF YOU DO THE RIGHT TYPE OF STATISTICAL TESTING, YOU'RE NOT GOING TO GET PUNISHED IF THERE IS A SMALL SEX DIFFERENCE, BUT YOU DON'T HAVE TO -- RIGHT FROM THE START EVERY EXPERIMENT THAT YOU DO SO THAT IF THERE IS A SEX DIFFERENCE, YOU'RE GOING TO FIND IT. IF YOU COMPARE 70 MALES AND 70 FEMALES, YOU'RE GOING TO FIND SEX DIFFERENCES, VERY IMPORTANT SEX DIFFERENCE MAYBE. SO I WONDER WHETHER THAT'S SOMETHING THAT YOU ADDRESS IN YOUR DOCUMENTATION. >> SO THE QUESTION IS ABOUT COSTS AND DOUBLING AND YES, WE HEAR THAT ALL THE TIME. AND THE FIRST THING I WOULD SAY IS THE BEST MONEY THAT WE CAN SPEND IS THE HIGHEST QUALITY SCIENCE. YOU POINTED OUT VERY CLEARLY HERE THAT STUDYING SEX DIFFERENCES IS SUCCINCT FROM STUDYING BOTH SEXES. AND I THINK PEOPLE ASSUME THAT WE ARE SAYING THAT THEY MUST POWER EVERY STUDY TO DETECT SEX DIFFERENCES AND THAT IS NOT WHAT WE PUT FORWARD. AND IT'S IMPORTANT TO MAKE THAT CLEAR, BECAUSE IT IS REPEATED ERRONEOUSLY THAT WE HAVE PUT THAT FORWARD AND WE DID NOT. AS YOU POINT OUT, SEX AS A BIOLOGICAL VARIABLE CAN BE FACTORED IN BY INCLUDING BOTH SEXES IN BOTH OF YOUR GROUPS, AND THE DESIGN -- VARIOUS DESIGNS THAT I MENTIONED, AND THAT DOES NOT NECESSARILY HAVE TO INCREASE THE NUMBER OF ANIMALS THAT YOU ARE STUDYING. THE MOST STRAIGHTFORWARD APPROACH WOULD BE HALF AND HALF OF THE EXISTING NUMBER THAT YOU'RE USING. THAT MAY OR MAY NOT BE APPROPRIATE DEPENDING ON YOUR QUESTION AND THE CIRCUMSTANCES, BUT THAT CERTAINLY WOULD BE A PLACE TO START. AND THE LAST THING I WANT TO SAY ABOUT COST IS THERE'S COST TO THE INDIVIDUAL INVESTIGATOR, THERE'S COST TO THE SCIENTIFIC FIELD AND WE HAVE AN AMBIGUOUS KNOWLEDGE BASE, THERE IS COST TO HUMAN BEINGS, WHEN WE EXPOSE THEM TO TREATMENTS THAT COULD BE TOXIC. AND WHEN WE EXPOS THEM TO TREATMENTS THAT WON'T WORK FOR THEM, THAT'S A HUMAN COST. SO WE'RE TRYING TO THINK ACROSS THE ENTIRE RESEARCH SPECTRUM AS TO THE MOST APPROPRIATE WAY TO ADDRESS SEX AS A BIOLOGICAL VARIABLE IN DIFFERENT PARTS OF THE SPECTRUM. SO IN BASIC BASIC RESEARCH, IT MAY BE APPROPRIATE TO DO IT ONE WAY. IN PRE-CLINICAL, CLEARLY, THAT IS A HARD CHECKPOINT. PRE-CLINICAL RESEARCH, YOU ARE INTENDING TO EITHER MODEL A DISEASE OR TRANSLATE SOMETHING. TO ME THAT'S A HARD CHECKPOINT WHERE YOU NEED TO MAKE SURE THAT THERE ARE NO TOXICITY, SAFETY, OR EFFICACY DIFFERENCES THAT ARE IMPORTANT SO THAT YOU CAN DID DESIGN YOUR EARLY PHASE CLINICAL WORK SO THAT WE CAN UNDERSTAND THEM. THERE'S NO REASON TO SAY WE WOULDN'T DEVELOP A DRUG OR INTERVENTION THAT'S APPROPRIATE FOR ONE SEX OR THE OTHER, BUT WE NEED TO BE TRANSPARENT ABOUT WHAT WE'RE DOING AND TRANSPARENT IN OUR DATA IN TERMS OF REPORTING THAT DATA DISAGGREGATED BY SEX FROM THE BEGINNING. DO YOU AGREE? >> [INAUDIBLE] [SPEAKER NOT AT MIC] >> FOR THE FOLKS ON THE VIDEOCAST, THAT WAS DR. LOUISE MCCULLOUGH, HIGHLIGHTING THE FACT THAT FIRST YOU NEED TO SELECT THE APPROPRIATE ANIMAL MODEL FOR THE DISEASE YOU'RE STUDYING, WHICH IS FUNDAMENTAL, AND I WOULD ARGUE THAT WE'RE NOT ALWAYS DOING THAT. WE'RE NOT REALLY TRYING TO CURE MOUSE LUPUS, WE'RE TRYING TO CURE HUMAN LUPUS, AND THAT UNDERSTANDING THAT IN SOME CASES, AING MAY BE AGE MAY BE A VERY IMPORTANT BIOLOGICAL VARIABLE SO IN THAT CONTEXT, IT MAY BE IMPORTANT FOR YOU TO CONSIDER THAT, AND OF COURSE SENESCENT ANIMALS, AGING ANIMALS, YOU HAVE TO KEEP THEM FOR A LONG TIME SO THERE ARE INCREASED COSTS ASSOCIATED WITH THAT. SO AGAIN, THE MOST RIGOROUS DESIGN FOR THAT RESEARCH QUESTION INVOLVED IN THOSE AGED ANIMALS, THOSE WOULD BE SUPPORTED IN YOUR BUDGET THAT YOU PUT FORWARD THAT GOES WITH YOUR APPLICATION. IF IT CAN BE JUSTIFIED SCIENTIFICALLY, THEN THERE'S AN OPPORTUNITY FOR THOSE FUNDS TO BE MADE AVAILABLE. WOULD IT MAKE SENSE FOR US TO -- FOR YOU TO USE, YOU KNOW, JUVENILE ANIMALS FOR YOUR RESEARCH QUESTION PAUSE I BECAUSE IT COSTS LESS? WHICH YOU'RE NOT. SO WE COULD FUND THAT AND WE COULD PAY LESS, BUT WE WOULD BE PAYING FOR POORER QUALITY SCIENCE, AND THE DATA WOULD NECESSARILY BE RELEVANT, WHICH I SAY IS THE OTHER R, WHICH IS IF YOU'RE DOING ALL THIS RESEARCH, IF YOU'RE SPENDING THIS MONEY, IF WE ARE TRAINING SCIENTIST, WE'RE TRAINING THEM AND PHYSICIANS AND CLINICIANS AND NURSES AND HEALTHCARE PROVIDERS TO PROVIDE CARE FOR EVERYONE. WE'RE TRYING TO LEARN INFORMATION THAT IS RELEVANT. UNDERSTANDING -- NOT TO SAY ANYTHING ABOUT NEONATAL STROKE, BUT THAT'S NOT THE QUESTION YOU WERE ASKING. SO THANKS, LOUISE. VALERIE? >> COMMENT AND QUESTION. YOU SHOWED A BUDGET OF ABOUT 34, $32 MILLION, AND WE USE $7 MILLION OF THAT BUDGET FOR ADMINISTRATIVE SUPPLEMENT. MY QUESTION IS, OF THAT 30-SOME MILLION DOLLARS THAT WAS USED FOR FUNDING RESEARCH, HOW CAN YOU -- DO YOU SEE CAPACITY BUILDING WITH THAT? IN OTHER WORDS, WERE SOME OF THOSE DOLLARS SHARED, CAPACITY BUILDING, WHERE NIMHD OR SOME OTHER INSTITUTE, ACTUALLY CONTRIBUTED SUCH THAT THE CAPACITY OF THAT $32 MILLION WAS STRETCHED, AND THEN HOW ARE WE GOING TO MEASURE THE RETURN ON THE INVESTMENT, OF TAKING A FIFTH OF THE REVENUE, THE $7 MILLION FOR THESE ADMINISTRATIVE SUPPLEMENTS? I UNDERSTAND WHY WE DID IT, BUT HOW ARE WE GOING TO MEASURE THAT RETURN ON INVESTMENT? >> AS ALWAYS, VALERIE, YOU GO RIGHT TO THE POINT. THOSE ARE REALLY, REALLY IMPORTANT QUESTIONS. SO THE FIRST IS THAT IS OUR RESEARCH BUDGET, THERE IS AN OPERATING BUDGET THAT I DIDN'T SHOW, BUT YES, BECAUSE ORWH DOES NOT HAVE DIRECT GRANT-MAKING AUTHORITY, EVERYTHING WE DO IS IN COLLABORATION WITH AN INSTITUTE OR CENTER. SO EVEN FOR THE SCORES, THERE'S AN INSTITUTE OR CENTER THAT'S ADMINISTERING THE GRANTS, AND THEY OFTEN SUPPORT THE SCORES TOO. SO WE ARE LEVERAGING THAT MONEY BY GETTING INVESTMENTS FROM OTHER ICs. THE OTHER IC COFUNDS, THE ICs ARE LEVERAGING THEIR INVESTMENTS, SO THE STRATEGY WE OFTEN USE FOR THOSE, WHICH I THINK WILL APPEAL TO YOU, IS THAT THERE ARE PROJECTS THAT WOULD NOT GET DONE IF WE WERE NOT INVOLVED. SO THERE ARE QUESTIONS THAT ARE SUFFICIENTLY CROSS CUTTING THAT DON'T FALL NEATLY IN 1I.C., AND THAT, WE TAKE ON AS A PERSONAL RESPONSIBILITY IF THAT IS AN IMPORTANT SCIENTIFIC QUESTION OR CLINICAL QUESTION FOR WOMEN. AND SO THAT IS PART OF OUR STRATEGIC PLANNING PROCESS, WHERE WE WANT TO KNOW WHAT THOSE AREAS ARE. THE SECOND PART OF YOUR QUESTION WAS RELATED TO MEASURING HOW WELL THE ADMINISTRATIVE SUPPLEMENTS DO. AND MEASURING THE IMPACT OF SCIENCE IN GENERAL IS NOT STRAIGHTFORWARD AS YOU KNOW. WE CAN DO THE BIBLIOMETRIC THINGS, I CAN TELL YOU ALL OF THE PAPERS AND ALL THAT, WE'LL DO THAT, THAT'S STRAIGHTFORWARD AND WE'RE DEVELOPING A VARIETY OF PORTFOLIO ANALYSIS TOOLS, BUT I WOULD SUBMIT TO YOU THAT THE NUMBER ONE RETURN ON THAT INVESTMENT TO ME IS THE SCIENTISTS WHO HAVE CHANGED THE WAY THEY THINK. BECAUSE THEY ARE GOING TO INFLUENCE ALL THE PEOPLE AROUND THEM. >> AND HOW WILL YOU MEASURE THAT AND TRACK THAT? >> SO IF THEY PUBLISH SOMETHING, SO THEY HAD A PARENT GRANT AND THIS IS A SUPPLEMENT. IF THEY PUBLISH SOMETHING RELATED TO FINDING FROM THE SUPPLEMENT, THAT'S ONE WAY WE CAN TRACK THAT. AND THAT, WE CAN DO. WE CAN TRACK IT THROUGH THE PROGRESS REPORT FROM THE SUPPLEMENT. AS WELL. BUT SOME OF THOSE OTHER THINGS ARE NOT MEASURABLE. THE OTHER THING WOULD BE IF THAT PROVIDES DATA THAT THEN INFORMS SUBSEQUENT APPLICATION, THAT NOW INCORPORATES SEX DIFFERENCES BECAUSE THERE'S PRELIMINARY DATA TO SUPPORT, YOU KNOW, A SAMPLE SIZE CALCULATION THAT'S REASONABLE, THEN THERE'S AN IMPACT THERE. SO WE CERTAINLY ARE OPEN TO DIFFERENT IDEAS ON HOW TO MEASURE AND ESPECIALLY MY OSSC COLLEAGUES AROUND THE TABLE, HOW DO YOU MEASURE -- WHAT'S THE APPROPRIATE METRIC FOR THIS KIND OF THING? SO FOR US, YOU KNOW, AT THE VERY BEGINNING OF DECIDING TO DO THAT PROGRAM, VALERIE, AT FIRST, THERE WAS THIS GOSH, PEOPLE SHOULD BE DOING THIS, IT'S THE BEST WAY TO DO THE SCIENCE, SHOULD WE PROVIDE FUNDS FOR PEOPLE TO DO WHAT THEY'RE SUPPOSED TO BE DOING. HONESTLY. AND WAS IT MORE IMPORTANT TO HAVE THAT KIND OF APPROACH AS OPPOSED TO ACTUALLY MAKING SOMETHING HAPPEN AND MOVING THE FIELD FORWARD CATALYTICALLY. SO THAT'S THE STRATEGY WE'RE USING. WE HAVE A POLICY NOW, THE SUPPLEMENTS PROGRAM IS NOT GOING TO BE HERE FOREVER BECAUSE WE HAVE A POLICY THAT EVERYONE IS SUPPOSED TO BE DOING THIS. SO ORWH DOESN'T HAVE TO DO THAT. >> I AGREE WITH YOUR APPROACH. I DO THINK THAT THERE'S SOME OF OUR COLLEAGUES SITTING AROUND THE TABLE WHO CAN HELP US WITH SOME METRICS TO MAKE SURE THAT WE CAN DOCUMENT IT AND IT'S ALWAYS GOOD TO HAVE PERSONS WHO YOU CAN DOCUMENT THAT THEY CHANGE THEIR PROCESS, AND IT LEVERAGED THEIR RESEARCH AND ACTUALLY TO ADVANCE THE SCIENCE, SO WE WANT TO MAKE SURE THAT WE ARE ABLE TO TRACK THAT. I DO THINK WE'RE GOING TO SEE IT SLOW, BUT SOMETIMES WE HAVE TO GIVE PEOPLE A FORUM REALLY TO ACTUALLY SHOW THAT THEY HAVE CHANGED. >> THANK YOU FOR THAT. CONNIE, THEN CAROLYN. >> IS THERE A WAY TO TRACK BEFORE AND AFTER THAT JANUARY POLICY FOR JUSTIFYING SEX DIFFERENCES AND REVIEWS OF APPLICATIONS? IT IT OUGHT TO BE PRETTY EASY FOR HUMANS BECAUSE YOU HAVE SOME WORK -- MALES AND FEMALES AND MAYBE WE CAN TEASE OUT THE ANIMAL, NOT SURE ABOUT THE CELL CULTURE, BUT THAT WOULD BE A GREAT FIRST METRIC. >> SO THE -- ARE YOU SUGGESTING TRACKING NUMBERS OF ANIMALS? >> NUMBERS OF APPLICATIONS, RIGHT. SO WE DO HAVE SOME BASELINE INFORMATION AND WE ARE DEVELOPING OUR EVALUATION STRATEGY FOR IMPLEMENTING THE POLICY. THE OER IS THE LEAD FOR THAT, THAT IS AN NIH-WIDE ISSUE, AND I LOOK FORWARD TO BE ABLE TO SHARE THAT WITH YOU IN THE FUTURE, BUT I JUST WANTED TO MAKE SURE THAT WE ALSO KIND OF RECOGNIZE THAT THE TRACKING NUMBERS OF ANIMALS WOULD NOT BE HELPFUL. NUMBERS OF STUDIES WILL BE INFORMATIVE. AREAS OF STUDY MIGHT BE INFORMATIVE, AND SO WE'LL BE HAPPY TO SHARE THAT WITH YOU ONCE THAT'S FULLY FORMED. CAROLYN? >> I JUST WANTED TO RETURN TO THE IMPORTANT ISSUE YOU WERE DISCUSSING ABOUT INCLUDING SEX DIFFERENCES IN THE DESIGN AND THE POINT THAT -- THE THORNY ESHOO OF POWER. SO I UNDERSTAND FROM WHAT YOU'RE SAYING THAT GOING FORWARD, OF COURSE, INVESTIGATORS WILL HAVE TO INCLUDE, IF IT'S APPROPRIATE TO THE CONDITION BEING STUDIED, AND 99.9% OF THE TIME IT WILL BE, THAT FEMALE AND MALE ANIMALS WOULD BE INCLUDED, FOR EXAMPLE, OR FEMALE AND MALE CELLS. PU GOING BACK TO THE ISSUE OF POWER, IF YOU'RE UNDERPOWERED, DO YOU RUN THE DANGER OF SHOWING NO DIFFERENCE AND THEN BEING ABLE TO SAY THERE'S NO DIFFERENCE BY VIRTUE OF SEX? >> SO LET ME ANSWER THAT QUICKLY. DR. HUDSON IS HERE AND I WANT TO MAKE SURE THAT WE RESPECT HER TIME, BUT WE HAVE TIME TO TALK ABOUT THAT. IN FACT, DO YOU MIND, CAROLYN, TO HOLD THAT ONE, THAT QUESTION FOR ME? >> I'D BE HAPPY TO HOLD IT -- >> I THINK WE NEED TO HAVE A LITTLE BIT MORE TIME ON THAT. >> I THINK SO, BECAUSE IT'S A BIG QUESTION, AND IT'S SOMETHING I THINK WE'RE ALL CONCERNED ABOUT, AND THAT WOULD BE GREAT IF WE COULD TALK ABOUT IT LATER. >> HAPPY TO DO THAT. >> SO IT'S MY PLEASURE TO INTRODUCE DR. KATHY HUDSON, THE DEPUTY DIRECTOR FOR SCIENCE, OUTREACH AND POLICY HERE AT THE NIH, SHE'S CURRENTLY LEANING THE PRESIDENT'S PRECISION MEDICINE INITIATIVE AND WAS A KEY ARCHITECTS FOR NCATS AS WELL AS THE NIH BRAIN INITIATIVE. DR. HUDSON HAS SERVED IN MANY LEADERSHIP ROLES AT NIH. SHE'S THE FOUNDER AND DIRECTOR OF -- SHE WAS THE FOUNDER AND DIRECTOR OF THE GENETICS AND PUBLIC POLICY CENTER AND ASSOCIATE PROFESSOR IN THE BURRMAN INSTITUTE OF BIOETHICS AT JOHNS HOPKINS UNIVERSITY. SHE HOLDS A PH.D. IN MOLECULAR BIOLOGY FROM THE UNIVERSITY OF CALIFORNIA AT BERKLEY, MASTERS OF SCIENCE AND MICROBIOLOGY FROM THE UNIVERSITY OF OF CHICAGO AND A BACHELOR OF ARTS IN BIOLOGY FROM CARLTON. PLEASE JOIN ME IN WELCOMING DR. KATHY HUDSON. WE SO APPRECIATE YOU TAKING YOUR TIME THIS MORNING TO TALK WITH US ABOUT THE PRECISION MEDICINE INITIATIVE. [APPLAUSE] >> THANK YOU, AND HAPPY ANNIVERSARY, IT'S AN EXCITING TIME TO BE ABLE TO BE TOGETHER AND CONGRATULATE JANINE AND HER PREDECESSORS AND ALL OF YOU ON 25 YEARS OF REALLY LEADING THE CHARGE AND MAKING SURE THAT WE ARE DOING EVERYTHING THAT WE CAN IN TERMS OF RESEARCH ON WOMEN'S HEALTH. I AM GOING TO TALK A LITTLE BIT ABOUT THIS EMERGING PROGRAM, THE PRECISION MEDICINE INITIATIVE, WHICH IS STILL VERY MUCH UNDER CONSTRUCTION. WE ARE ACTIVELY CONTINUING TO SEEK INPUT AND ADVICE ON HOW TO BUILD THIS IN AN EXCITING AND RESPONSIBLE WAY, AND SO I'M EXCITED TO BE HERE TALKING TO YOU ABOUT IT TODAY. THE MOTIVATE VAITION FOR CREATING THIS PROGRAM, WE STILL HAVE INEFFECTIVE WAYS OF IN SOME CASES GETTING TO A GOOD DIAGNOSIS, IN OTHER CASES, TOO OFTEN WE END UP IN A SITUATION WHERE WE COME TO THE END OF THE ROAD AND EITHER FOR US OR A LOVED ONE, THERE IS NO TREATMENT OR EFFECTIVE INTERVENTION THAT'S AVAILABLE. AT THE SAME TIME, TRYING TO ADDRESS THIS KEY SCIENTIFIC AND MEDICAL CHALLENGE, THERE'S ALSO A CULTURAL CHALLENGE, WHICH IS THAT TOO OFTEN IN BIOMEDICAL RESEARCH, RESEARCH PARTICIPANTS ARE TREATED AS SUBJECTS AND, IN FACT, THE OVERARCHING REGULATIONS FOR PROTECTING HUMAN BEINGS IN RESEARCH CALLS THEM SUBJECTS. RIGHT? SO PROTECTING AND SUBJECTS, AND REALLY NOT TREATING PEOPLE AS PARTNERS AND ENGAGED WITH US AS WE DESIGN AND IMPLEMENT RESEARCH. AND THEN, OF COURSE, THERE IS DEPRESSING STATISTICS ON HOW LONG IT TAKES FOR ANY GIVEN RESEARCH FINDING TO MAKE ITS WAY INTO WIDESPREAD CLINICAL PRACTICE. SO THOSE WERE SOME OF THE CHALLENGES THAT WE WERE LOOKING AT, AND IN JANUARY OF THIS YEAR, IT WAS QUITE EXCITING WHEN THE PRESIDENT ANNOUNCED THE LAUNCH OF THIS INITIATIVE, AND I'LL PLAY THIS VIDEO FOR YOU. WE WERE ALL GATHERED IT -- THOSE OF US WHO HAVE BEEN WORKING ON THE VERY BEGINNING SCAFFOLD OF THIS PROGRAM WERE ALL GATHERED AND FRANCIS' HOUSE WITH THE APPROPRIATE LI LIBATIONS, AND WE DIDN'T KNOW ACTUALLY, WHETHER OR NOT, HE WOULD MENTION THE PRECISION MEDICINE INITIATIVE IN THE STATE OF THE UNION, SO WE WERE QUITE EXCITED WHEN HE ACTUALLY DID. >> TONIGHT I'M LAUNCHING A NEW PRECISION MEDICINE INITIATIVE TO BRING US CLOSER TO CURING DISEASES LIKE CANCER AND DIABETES, AND TO GIVE ALL OF US ACCESS TO THE PERSONALIZED INFORMATION WE NEED TO KEEP OURSELVES AND OUR FAMILIES HEALTHIER. WE CAN DO THIS. >> WE KNOW WHO YOU ARE. >> [INAUDIBLE] >> IT TURNS OUT WE DIDN'T ACTUALLY HEAR EVERYTHING THAT HE SAID BECAUSE WHEN HE SAID "AND TONIGHT I'M GOING TO LAUNCH THE PR --" WE ALL STOOD UP AND STARTED HUGGING EACH OTHER. SO NOBODY REALLY KNEW EXACTLY WHAT THIS PRECISION MEDICINE INITIATIVE WAS, NOT EVEN US. SO THE OTHER INTERESTING STATISTIC ABOUT THIS THAT I'LL SHARE WITH YOU IS THAT THERE WERE PEOPLE DOING POLLING DURING THE STATE OF THE UNION, AND THIS HAS BEEN DONE DURING PRESIDENTIAL DEBATES AND THE LIKE WHERE PEOPLE BASICALLY HAVE FINGERS ON THEIR KEYBOARD AND THEY -- YOU KNOW, I'M FEELING GOOD, FEELING POSITIVE ABOUT THAT, FEELING NEGATIVE, NEGATIVE ABOUT THAT, AND THE MOST POS ITTIVE MOMENT IN THE STATE OF THE UNION ADDRESS WAS THAT MOMENT. WHEN HE SAID I'M LAUNCHING THE PRECISION MEDICINE INITIATIVE. SO IT WAS PRETTY INTERESTING FROM SORT OF A PSYCHOLOGICAL POINT OF VIEW. SO AS I MENTIONED, THERE ARE SORT OF THESE CORE VALUES HA HAVE BEEN A PART OF THIS FROM THE GET-GO. ONE IS THAT WE WANT TO BE ABLE TO HAVE PARTICIPATION IN THIS PROGRAM OPEN TO ALL INTERESTED INDIVIDUALS, WE WANT PARTICIPANTS TO BE OUR PARTNERS IN THE CONSTRUCTION GOVERNANCE OVERSIGHT EVALUATION AND THE LIKE, THAT PARTICIPANTS WILL BE PROVIDED ACCESS TO INFORMATION ALONG THE WAY, AND THAT THE CORE VALUES OF DATA SHARING FOR RESEARCH PURPOSES, OF COURSE, WILL BE EMBODIED ACTIVELY. AND THAT WE WILL DO EVERYTHING HA WE CAN TO PROTECT THE PRIVACY AND SECURITY OF THE INFORMATION THAT IS COLLECTED AS PART OF THIS PROGRAM. SO WE REALLY DO A LOT OF WHAT WE DO AS A CATALYST FOR HOW WE DO RESEARCH IN BROADER WAYS. SO THERE HAVE BEEN A NUMBER OF AREAS WHERE WHAT WE'RE DOING AS WE'RE LOOKING AT BUILDING THIS PROGRAM, WE REALIZE THERE ARE POLICIES THAT NEED TO BE IN PLACE, AND THAT THOSE POLICIES WILL BE REALLY IMPORTANT FOR THE SUCCESS OF THE COHORT PROGRAM BUT THEY ALSO HAVE MUCH WIDER SPREAD OF POSITIVE IMPLICATIONS. AND I'LL TALK A LITTLE BIT ABOUT SOME OF THOSE. SO THIS IS SORT OF THE NOTION THAT THIS LITTLE PROGRAM WHICH IS REALLY PRETTY MODEST IN THE BIG SCHEME OF THINGS, I THINK IS IS GOING TO HAVE A MUCH, MUCH WIDER SPREAD IMPLICATIONS. SO BACK IN 2004, FRANCIS WROTE IN ARTICLE IN WHICH HE PROPOSE TODAY BUILD A LARGE COHORT OF 500,000 PEOPLE TO LOOK AT THIS GENETIC AND ENVIRONMENTAL CONTRIBUTORS TO HEALTH AND DISEASE. AND HE THOUGHT -- AND HE ACTUALLY SAYS IN THIS ARTICLE THAT THE TIME IS NOW, AND HE WAS WRONG. IT WAS NOT -- THE TIME WAS NOT THEN. AT THAT TIME, THE COST OF SEQUENCING WAS ASTRONOMICAL, THERE WAS NO SUCH THING AS MOBILE DEVICES THAT WE CAN ALL NOW CARRY AROUND AND RECORD DATA ON AND THEY CAN TRACK IT PASSIVELY AND MONITOR THE ENVIRONMENT AROUND US. THERE WERE NO ELECTRONIC MEDICAL RECORDS AT ALL IN 2004, AND SO EVERYTHING HAS REALLY BEEN TRANSFORMED IN SUCH A WAY TO MAKE NOW THE TIME, NOT IN 2004, THE RIGHT TIME TO LAUNCH THIS INITIATIVE. SO THE PRESIDENT PROPOSED THAT THERE BE $200 MILLION FOR THIS INITIATIVE AT THE NATIONAL INSTITUTES OF HEALTH AND IT HAS TWO COMPONENTS AND I'M REALLY ONLY GOING TO TALK ABOUT ONE. SO ONE OF THEM IS PMI FOR ONCOLOGY. THAT MONEY IS DESIGNATED FOR DR. LOWY AND HIS COLLEAGUES AT THE NATIONAL CANCER INSTITUTE AND IS REALLY FOCUSED ON CLINICAL TRIALS IN WHICH GENOTYPE -- THE GENOTYPE OF THE UNDERLYING TUMOR IS USED TO SELECT AN AGENT IRRESPECTIVE OF WHAT THE INTENDED USE OF THAT AGENT CURRENTLY IS. AND CALLED MATCH TRIALS, MOLECULAR ANALYSIS OF THERAPEUTIC CHOICE. SO THAT'S ACTUALLY ALREADY UNDERWAY AND THIS NEW INFUSION OF MONEY WILL ALLOW THAT TO BE MUCH LARGER, AND TO INCLUDE A PEDIATRICS COMPONENT. SO BOTH OF THOSE ARE PRETTY EXCITING. THE $130 MILLION FOR THIS YEAR IS FOR THE COHORT WILLY TALK ABOUT. THERE WAS A LITTLE REQUESTED FOR THE FOOD AND DRUG ADMINISTRATION SO THEY CAN MODERNIZE THEIR REGULATORY OVERSIGHT OF ESPECIALLY GENETIC TECHNOLOGY. AND A LITTLE DOLLUP FOR ELECTRONIC MEDICAL RECORD INTEROPERABILITY AND ALSO ON THE BLUE BUTTON TECHNOLOGY, SO THE NOTION OF IF YOU CAN GET ACCESS EASILY TO YOUR OWN INTEGRATED ELECTRONIC MEDICAL RECORDS, THEN YOU CAN HAVE THE OPPORTUNITY TO SHARE THAT FOR RESEARCH PURPOSES, HOPEFULLY IN A FRICTIONLESS WAY, THAT'S CALLED BLUE BUTTON. RIGHT NOW IT DOESN'T REALLY QUITE WORK, BUT THERE ARE SOME NEW IMPORTANT STRIDES BEING TAKEN FORWARD ABOUT THAT RIGHT NOW ACTUALLY, AND IN PART CATALYZED BY PMI. SO IN MARCH, FRANCIS PUT TOGETHER A WORKING GROUP TO REALLY LAY OUT A BLUEPRINT FOR THIS PROGRAM AND TO THINK ABOUT HOW WE LEVERAGE THIS WITH EXISTING COHORTS OR START FROM SCRATCH, HOW ARE WE GOING TO CAPTURE THE DIVERSITY OF THE POPULATION, WHAT KINDS OF DATA, WHAT KINDS OF POLICIES NEED TO BE IN PLACE. THE WORKING GROUP NUMBERS ARE LISTED HERE. IT WAS A REALLY DIVERSE GROUP IN TERMS OF EXPERTISE AND EXPERIENCE, SO WE HAD FOLKS FROM PATIENT ENGAGEMENT EXPERTS TO ERIC FISHMAN FROM INTEL, TO ES ESTABON WHO FOCUSES ON DISPARITY ISSUES, HE HAD REALLY PROMINENT FOLKS FROM THE PRIVATE SECTOR, AND WE CAME TO THE TABLE INITIALLY IN VERY DIFFERENT PLACES, AND BY THE END OF OUR WORK TOGETHER, REALLY WERE OF A SINGLE MIND ABOUT THE REPORT THAT WE DEVELOPED TOGETHER. SO WE HELD A NUMBER OF WORKSHOPS TO GET INPUT ON DIFFERENT ISSUES AND THEY ARE LISTED THERE, I WON'T READ THEM ALOUD TO YOU, PUT OUT REQUEST FOR INFORMATION TO GET INFORMATION ON SPECIFIC TOPICS, WE WERE ABLE IT TO GET A SURVEY TO UNDERSTAND WHAT THE PUBLIC'S VIEWS WOULD BE, ARE, ABOUT THE PROSPECT OF BUILDING SUCH A COHORT, AND THEN WE WORKED WITH THE WHITE HOUSE AND OTHER AGENCIES TO DEVELOP PRIVACY AND TRUST PRINCIPLES WHICH ARE NOW BEING FINALIZED BY THE WHITE HOUSE. SO EARLY ON, WE WANTED TO MAKE SURE THAT WE HAD CLEARLY IN OUR MINDS, WHAT WERE THE SCIENTIFIC QUESTIONS THAT WE WANTED TO BE ABLE TO ASK AND ANSWER IN THIS COHORT, AND UNIQUELY IN THIS COHORT. SO IF YOU COULD ANSWER IN ANOTHER WAY, WHY BOTHER BUILDING -- AND ALSO REALLY TO BE ABLE TO HAVE SOME USE CASES OR EXAMPLES OF SCIENCE THAT WE WANT TO DO WHERE WE COULD ASK THOSE QUESTIONS AND ANSWER THOSE QUESTIONS EARLY IN A WAY THAT DELIVERED VALUE FOR THE SCIENTIFIC RESEARCH COMMUNITY IN THE SHORT TERM, BUT EQUALLY IMPORTANTLY, DELIVER SOMETHING OF VALUE TO THE PARTICIPANTS. SO RECRUITING PEOPLE IS GOING TO BE A CHALLENGE, KEEPING THEM ENGAGED AS WE GO IS PROBABLY EVEN A BIGGER CHALLENGE, AND SO WHAT KINDS OF ENGAGEMENT STRATEGIES MIGHT WE HAVE. SO AMONG THE THINGS HERE THAT WE HAVE LISTED AS SCIENTIFIC OPPORTUNITIES IN THE PMI, ONE THAT I LIKE TO THINK ABOUT IS SOMETHING FOR NEAR TERM SORT OF A 3 TO 5-YEAR HORIZON AS BEING ABLE TO LOOK AT PHARMACOGENETICS IN THE COHORT. SO WE COULD COLLECT BIOLOGICAL SPECIMENS AND LOOK AT THE PHARMACOGENETIC VARIANTS THAT WE ALREADY KNOW ARE INVOLVED IN DRUG RESPONSE AND PROVIDE THAT INFORMATION BACK TO PEOPLE AND MAYBE PROVIDE IT IN A WAY WHERE THEY CAN ACCESS IT EASILY, SO RIGHT NOW THERE'S LOTS OF DRUGS THAT HAVE GENETIC INDICATIONS IN THE DRUG LABEL, BUT WHEN YOU SHOW UP IN YOUR DOCTOR'S OFFICE, THEY'RE NOT GOING TO DO A BLOOD DRAW, SEND IT OFF, GET THE RESULTS BACK BEFORE THEY WRITE YOU A PRESCRIPTION. IT'S JUST NOT GOING TO HAPPEN. SO IF YOU ALREADY HAVE THAT INFORMATION WITH YOU, WHAT WILL THAT MEAN, AND CERTAINLY BEING ABLE TO IDENTIFY OTHER NEW VARIANTS ASSOCIATED WITH DRUG RESPONSE AS WE MOVE FORWARD. SO WE BUILT A COHORT OF A MILLION OR MORE VOLUNTEERS, BUT NOT TO BE A STATISTICALLY REPRESENTATIVE SAMPLE, AND WE CAN TALK ABOUT THAT IF YOU'RE INTERESTED. IT WILL BE A LONGITUDINAL COHORT AND HAVE SETTLED UPON HAVING TWO IT DIFFERENT METHODS OF RECRUITMENT. ONE IN WHICH WE PARTNER WITH HEALTHCARE PROVIDER ORGANIZATIONS THAT HAVE LARGE PATIENT POPULATIONS AND SOPHISTICATED ELECTRONIC MEDICAL RECORDS AND PARTNER WITH THEM TO SEEK VOLUNTEERS TO PARTICIPATE IN THE COHORT. BUT THE PRESIDENT REALLY WANTED REALLY ANYONE ANYWHERE TO BE ABLE TO VOLUNTEER TO PARTICIPATE IN THE COHORT, AND THAT BECOMES MORE CHALLENGING. WHILE THE PRESIDENT WAS GIVING THE STATE OF THE UNION ADDRESS, MY MOTHER, WHO'S VERY CRIPPLED WITH RHEUMATOID ARTHRITIS, USED HER STYLUS TO STIEP A TYPE AN EMAIL TO ME SAYING "WHERE DO I VOLUNTEER?" SO HOW DO I MAKE IT POSSIBLE FOR MY MOM, WHO IS VERY CRIPPLED, TO BE ABLE TO VOLUNTEER FOR THIS COHORT? SO I KEEP HER TOP OF MIND ALL THE TIME. AND SO WE ARE DOING SOMETHING WHICH WE HAVEN'T REALLY DONE AT THE NIH IN QUITE THIS WAY BEFORE, SO THIS IT WILL BE AN INTERESTING CHALLENGE. IN TERMS OF THE CORE DATASET, LOTS OF ANIMATED CONVERSATIONS BECAUSE EVERYBODY WANTS EVERYTHING. WHAT WE SETTLED UPON WAS NOT LET THE PERFECT BE THE ENEMY OF THE GOOD AND WE NEEDED TO START WITH A SMALL CORE DATASET WITH THE NOTION THAT IT WOULD EVOLVE AND EXPAND OVER TIME AND THAT WE CAN'T GET LOCKED INTO WHAT WE DO AT THE LAUNCH AS THE THING THAT WE WILL DO FOREVER, AND THAT HAS BEEN ONE OF THE SORT OF FLAWS IN SOME STUDIES THAT HAVE NOT WORKED OUT QUITE SO WELL, AND WE REALLY BENEFITED FROM LOOKING AT OTHER VERY SUCCESSFUL AND VERY UNSUCCESSFUL COHORT PROGRAMS. SO THESE ARE THE DATA THAT WE WANT TO COLLECT AT THE GET-GO. SELF-REPORTED MEASURES, WE WANT A BASELINE HEALTH EXAMPLE FOR THE FOLKS IN HEALTHCARE PROVIDER ORGANIZATIONS, STRUCTURED CLINICAL DATA FROM EHR, BIOSPECIMENS FROM EVERYONE, AND WE HOPE TO HAVE MHEALTH AT LEAST IN SOME PART OF THE COHORT VERY EARLY ON. SO THIS REPRESENTS THE TWO SOURCES OF VOLUNTEERS, THE DIRECT VOLUNTEERS IN BLUE AND THE VOLUNTEERS THROUGH HEALTHCARE PROVIDER ORGANIZATIONS IN GREEN. ALL OF THAT DATA AND BIOLOGICAL SPECIMENS COMING TOGETHER IN A BIOREPOSITORY AND IN A CLOUD-BASED SECURE DATA INFRASTRUCTURE. WE WILL COLLECT BIOSPECIMENS AND DO THAT IN A CLIA-COMPLIANT WAY AND TO PROVIDE THE INFORMATION BACK FROM THE RESULTS OF THOSE ANALYSIS TO THE PARTICIPANTS. OVER TIME, AS I MENTIONED, WE WANT TO GROW THE KIND OF DATA THAT WE WILL COLLECT AND SOME OF THAT IS LISTED HERE, AND INCLUDING EXPANDING THE KINDS OF ANALYSIS THAT WE DO ON THE BIOLOGICAL SPECIMENS. SO I SHOWED YOU INFORMATION FLOWING IN TO THE PROGRAM, INFORMATION FLOWING OUT, AND TO RESEARCHERS TO GENERATE, TO ASK INTERESTING QUESTIONS, AND IMPORTANTLY, TO THE VOLUNTEERS THEMSELVES. SOME LEVEL OF THIS DATA, WE'D LIKE TO HAVE BEEN COMPLETELY PUBLIC SO THAT ANYBODY, A HIGH SCHOOL STUDENT, AVERAGE CITIZEN CAN ACCESS THIS AND DO CITIZEN SCIENCE WITH THIS DATA, BECAUSE YOU DON'T ALWAYS KNOW WHERE THE GOOD IDEAS WILL COME FROM. AND OF COURSE THIS DATASET WILL GROW OVER TIME. SO WE WILL RETURN INFORMATION BOTH -- INTENTIONALITY, WE WILL PLAN WHAT DATA WE WILL ANALYZE AND WHAT WE -- SO WE DON'T END UP IN A SITUATION WHERE WE'RE FEELING UNCOMFORTABLE ABOUT HOW TO RETURN INFORMATION OR WHEN TO RETURN INFORMATION. THERE WILL BE SOME ANALYSES THAT WILL BE UNDERTAKEN, PROBABLY NOT IN CLIA-CERTIFIED LABORATORIES THAT ARE REALLY EXPLORATORY, AND FOR THOSE DATA, WE ANTICIPATE THAT IF PEOPLE ASK FOR THEM, WE WILL GIVE THEM, BUT WE WILL DO IT SURROUNDED BY LOTS OF DISCLAIMERS ABOUT WE DON'T KNOW WHAT THIS MEANS, BUT WITH THE NOTION THAT PEOPLE SHOULD HAVE THE RIGHT TO KNOW WHAT WE KNOW ABOUT THEM. AND THIS HAS BEEN VERY IMPORTANT TO THE PRESIDENT, IN FACT, THE LAST TIME THAT WE MET WITH HIM ABOUT THIS TOPIC IN JULY, HE SAID IF YOU END UP -- YOU GUYS ARE THE EXPERTS, BUT TO THE EXTENT THAT YOU END UP WITH ANY RESTRICTIONS ON THE INFORMATION THAT PEOPLE FORGET ABOUT THEMSELVES, YOU NEED TO COME AND CHECK BACK IN WITH ME ABOUT THAT. SO THAT WAS A PRETTY CLEAR SIGNAL WHERE HIS HEAD WAS. THERE ARE A NUMBER OF POLICY ISSUES THAT HAVE BEEN REALLY ADVANCED BECAUSE OF PMI. ONE IS, THE POLICY THAT NIH HAS PROPOSED AND WILL BE FINALIZING THIS IT FALL. PRIVACY AND SECURITY STANDARDS, WHICH ARE ACTIVELY BEING EXPLORED AND EXPANDED, PARTICULARLY NOW IN THE WAKE OF THE OPM BREACH. WE WANT TO MAKE SURE THE STANDARDS FOR HIPAA AND CLIA ARE ALIGNED, THEY'RE OFF KILTER RIGHT NOW, AND WE'LL NEED TO BUILD SPECIAL POLICY CONSIDERATIONS FOR THE INCLUSION OF DIFFERENT KINDS OF FOLKS IN THE COHORT, SO OUR EXPECTATIONS IS THAT WE WILL INCLUDE PEOPLE OF ALL AGES AND ALL STAGES OF LIFE, BUT IN ORDER TO DO THAT, WE'RE GOING TO HAVE TO HAVE SPECIAL -- DEEP THOUGHT ABOUT THAT BEFORE WE JUST START, SO THAT WILL INCLUDE CHILDREN, FOLKS WHO ARE OR BECOME DECISIONALLY IMPAIRED OR BECOME INCARCERATED DURING THE COURSE OF THE STUDY. SO THE GOVERNANCE STRUCTURE, SOMEONE WILL REPORT TO THE NIH DIRECTOR. AN INTERIM DIRECTOR HAS BEEN NAMED AND ACTING IN THIS ROLE RIGHT NOW. WE WILL BE SOON ANNOUNCING AN INDEPENDENT ADVISORY BOARD THAT WILL BE RESPONSIBLE FOR OVERSIGHT AND NURTURING THIS PROGRAM SPECIFICALLY OVER TIME, AND THIS GROUP WILL HAVE A SUBSTANTIAL REPRESENTATION FOR VOICES OF PEOPLE WHO REPRESENT THE PARTICIPANTS. THEN WE'LL HAVE A STEERING COMMITTEE WITH THE EXECUTIVE COMMITTEE THAT WILL BE MADE UP OF ALL THE FUNCTIONAL UNITS OF THIS COMPLEX ENTERPRISE, AND THEN WE WILL CONTINUE TO WORK CLOSELY WITH OUR SISTER AGENCIES, ONC, THE OFFICE OF CIVIL RIGHTS, FOOD AND DRUG ADMINISTRATION, HRSA, BECAUSE WE WANT TO USE FEDERALLY QUALIFIED HEALTH CENTERS AS ONE INPUT, ESPECIALLY TO BE ABLE TO GET UNDERREPRESENTED GROUPS INTO THE COHORT, AND THEN WORKING CLOSELY WITH THE WHITE HOUSE. SO I MENTIONED THAT PARTICIPANT ENGAGEMENT IS REALLY CORE, AND THIS IS SOME OF THE AREAS IN WHICH PARTICIPANTS WILL BE INTIMATELY INVOLVED ALONG THE WAY. SO AS WE BEGIN TO IMPLEMENT THIS PROGRAM, WE'RE STARTING TO PUT THINGS INTO A SEQUENCE AND THIS IS ON A TIMELINE, BUT THIS TIMELINE HAS NO UNITS ON IT AT ALL. WE'RE STILL VERY MUCH IN THE THINKING THROUGH ALL THIS PHASE SO THE THINGS UP IN THE LEFT-HAND CORNER, WE'RE WORKING VERY HARD ON NOW, AND WE'LL PROBABLY BE PUTTING OUT -- IN THE NEXT COUPLE OF WEEKS TO START TO PUT SOME OF THIS STUFF IN PLACE. WHAT WE HAVE DECIDED TO DO IS TO LAUNCH THE DIRECT VOLUNTEER ENROLLMENT PART OF THIS FIRST, SO THAT'S ONE DOOR TO ENTER INTO THE COHORT, AND WE'RE GOING TO LAUNCH THAT SOON AND THEN WE'RE GOING TO BE PUTTING OUT SORT OF STANDARD TRADITIONAL NIH RFAs FOR HEALTH ORGANIZES LIKE KAISER, THOSE WERE BIG POPULATIONS, AND WOULD MAKE THOSE AWARDS LATER THIS YEAR, BUT THERE WILL BE A LAG TIME BECAUSE GETTING THE APPLICATIONS IN, REVIEWING THEM, MAKING THE AWARDS. SO THAT'S SORT OF OUR GENERAL IMPLEMENTATION PLAN. AGAIN, SORT OF MOSTLY WRITTEN IN PEN SELL. THE FIRST FORM WAS WRITTEN ON WHITE BOARD IN MY OFFICE SO IT'S STILL THERE AND STILL KIND OF FRESH IN OUR MINDS. SO I WANT TO SEGUE A LITTLE BIT INTO TALKING ABOUT WOMEN, AND WHEN I WALKED IN, JANINE, YOU WERE TALKING ABOUT INCLUSION OF SEX AS A BIOLOGICAL VARIABLE IN RESEARCH IN THE NEW SORT OF REQUIREMENTS AND EXPECTATIONS ABOUT THAT, AND A HAT TIP TO JANINE FOR REALLY LEADING OUR THINKING ABOUT THAT IN THIS BUILDING AND ACROSS THE COUNTRY. AS YOU GUYS ALL APPRECIATE, AND I THINK FOR ME, THINKING ABOUT PARTICIPATION IN THE COHORT, SORT OF STRATEGIES FOR ENGAGEMENT IN THE COHORT, IT'S USEFUL TO KEEP IN MIND WOMEN'S SPECIAL ROLE WITH RESPECT TO HEALTH AND HEALTHCARE AND ESPECIALLY HEALTH AND HEALTHCARE FOR THEIR FAMILIES. SO THINKING ABOUT RECRUITING INDIVIDUALS AND THEN RECRUITING UP A GENERATION AND DOWN A GENERATION MIGHT BE AN INTERESTING APPROACH, PARTICULARLY FOCUSED AROUND STRATEGIES TO ENROLL WOMEN. AND THEN I'M SURE YOU GUYS HAVE BEEN TALKING ABOUT IT BUT CERTAINLY HIGH IN MY MIND, AS WE MOVE FORWARD WITH THE COHORT, IS THAT WE NEED TO HAVE THE COHORT ENABLE STUDIES THAT WILL HELP REDUCE THE DISPARITY BOTH IN PARTICIPATION BUT ALSO HEALTH DISPARITIES MORE BROADLY, AND SO WE WANT TO BE ABLE TO MAKE SURE TO INCLUDE THOSE THOUGHTS AS WE MOVE FORWARD. THEN HOPEFULLY WE WILL BE ABLE TO NURTURE WOMEN INVESTIGATORS AS A PART OF THE TEAM OF FOLKS WHO HELP BUILD THIS COHORT AND USE THIS COHORT ESPECIALLY RETAINING PEOPLE AND SENIOR POSITIONS LATER IN THEIR CAREER, SO IT'S A SIGNIFICANT PROBLEM. SO I'LL BE INTERESTED IN YOUR VIEWS ABOUT HOW WE CAN WEAVE TOGETHER THE ISSUES AND EXPERTISE THAT YOU HAVE TOGETHER IN THE AREA OF WOMEN'S HEALTH RESEARCH AS WE MOVE FORWARD IN BUILDING THIS EXCITING NEW PROGRAM OF PRECISION MEDICINE INITIATIVE COHORT PROGRAM. SO WITH THAT, I WILL THANK YOU VERY MUCH FOR WROWR ATTENTION ANYOURFOR YOUR ATTENTION ANDI'D BE HAPPY T O TAKE QUESTIONS. [APPLAUSE] >> THANK YOU, DR. HUDSON. DR. NELSON. >> HI, THIS IS REALLY EXCITING AND IT'S GREAT TO HEAR IT FROM YOU TODAY. I WAS STANDING UP CHEERING WHEN I HEARD IT FROM BARACK OBAMA AS WELL THAT NIGHT, THAT WAS REALLY COOL. THE THING THAT'S BOTHERING ME EVER SINCE I KNEW THIS WAS LAUNCHING WAS THE WHOLE ISSUE ABOUT ELECTRONIC MEDICAL RECORD DATA. I SERVE AT MEDICAL DIRECTOR IN A FIVE-STATE HEALTH SYSTEM, MILLIONS OF PEOPLE, AND DESPITE BEING UNDER ONE HUGE UMBRELLA, THE EPIC DHR IS DIFFERENT IN EVERY LITTLE DISTRICT. VENDORS HAVE THEIR OWN PRODUCTS THAT PROHIBIT CRACKING INTO -- EVEN THOUGH WE'VE DONE A LOT OF REVERSE ENGINEERING IN ORDER TO EXTRACT DATA THAT WE NEED JUST TO RUN THE PLACE, BUT TO ALSO ASK A FEW RESEARCH QUESTIONS OURSELVES. SO IT'S BEEN DESIGNED FOR BUSINESS PURPOSES, NOT EVEN REALLY FOR PATIENT CARE. AND IT HAS -- I'M SORRY I'M BEING A CRITIC BUT IT IS INDEED TRUE, WE'VE BEEN ABLE TO WORK WITH IT NOW, AFTER INVESTING BILBILLIONS OF DOLLARS, INTEGRATION IS VERY DIFFICULT. AND THAT'S ONE HEALTH SYSTEM. SO I HAVE CONCERNS THAT WE'VE MISSED A HUGE OPPORTUNITY TO CREATE A RESEARCH DATABASE FROM THE BEGINNING. IT DOESN'T MEAN IT'S OVER AND THAT WE CAN RECOVER ALL THAT, BUT I'M JUST WONDERING HOW TO CRACK INTO THAT ISSUE, IT'S AN UNFORTUNATE LOSS OF OPPORTUNITY TO THIS POINT, BUT HOPEFULLY A WHOLE NEW EPISODE AHEAD OF US WHERE WE CAN ACTUALLY FIX THAT. I KNOW EHR IS A BIG PART OF YOUR -- >> YOU'RE ABSOLUTELY SPOT ON. WHEN WE FIRST BEGAN GOING DOWN THIS ROAD, THE THING THAT JUST FELT INSOLVABLE TO ME, AND WOKE ME UP AT NIGHT, WAS THIS ISSUE OF THE -- SORT OF THE MYTH OF INTEROPERABILITY AND THE MYTH OF BLUE BUTTON AND HOW ARE WE GOING TO -- WITH THE SYSTEM I DIDN'T EVEN FELT LIKE I UNDERSTOOD VERY WELL, AND THEN CERTAINLY LIKE THE TOOL TO MOVE IT FORWARD, THE WHOLE BUSINESS ABOUT MEANINGFUL USE, MEANINGFUL USE FOR BILLING PURPOSES ESSENTIALLY, AND THEN INCREASINGLY MEANINGFUL USE FOR CARE PROVISION, BUT NOT MEANINGFUL RESEARCH. SO THAT'S NEVER BEEN A SERIOUS PART OF THE CONVERSATION, AND I THINK NOW WE'RE SEEING THAT BECOMING A PART OF THE CONVERSATION. SO ONE OF THE THINGS THAT HAS HAPPENED AS A PART OF THE PRECISION MEDICINE INITIATIVE IS REALLY A VERY CLEAR FOCUS AND PURPOSE FROM PEOPLE IN THE DEPARTMENT AND PEOPLE IN THE WHITE HOUSE ON TRYING TO MAKE SURE THAT WE REALLY DO ADVANCE TARGETS IN TERMS OF INTEROPERABILITY AND BLUE BUTTON AND BEING ABLE TO TRULY ENABLE THINKING FOR SCIENCE, SO THAT IS STRAIGHTFORWARD. I KNOW ELECTRONIC MEDICAL RECORDS DON'T WORK BECAUSE WHEN I MOVE MY MOM FROM TEXAS TO ST. PAUL, I HAD, IN THE BACK -- SHE FLEW AND I DROVE HER VAN, AND IN THE BACK OF THE VAN, I HAD BOXES OF PAPER ELECTRONIC MEDICAL RECORDS. SO I KNOW IT DOESN'T WORK, AND FOR THOSE OF US WHO WERE TRYING TO TAKE CARE OF OUR FAMILIES, WHETHER OUR KIDS, OUR PARENTS, IT WOULD BE SO WONDERFUL IF WE HAD AN INTEGRATED AGGREGATED SET OF INFORMATION THAT WE COULD EASILY AND SEAMLESSLY ACCESS. SO THAT, I THINK IS GOING TO BE ONE OF THESE WIDER SPREAD BENEFICIAL EFFECTS OF WHAT PMI IS AT THAT TIMIZING HERE, AND IT MAKES ME JUST SUPER EXCITED TO BE A PART OF THIS THING THAT'S GOING TO HAVE MUCH BROADER IMPLICATIONS, BUT THERE'S A TEAM OF -- THERE'S NEW POLICIES BEING PUT OUT EVEN AS RECENTLY AS LAST WEEK FROM THE OFFICE OF NATIONAL COORDINATOR TRYING TO ADVANCE THESE, SO I'M EXCITED ABOUT WHERE WE'RE GOING BUT IT IS A BIG HILL. >> THAT COULD REALLY CHANGE THE WHOLE WORLD, SO THAT'S PRETTY EXCITING. A LOT OF PEOPLE WILL BE WATCHING YOU DO THAT. >> AND HELPING. >> YEAH, HELPING. WE WANT TO SEE THAT DATA TOO AND WORK WITH IT. IT'S REALLY A CRIME WE CAN'T DO IT TODAY, BUT MAYBE TOMORROW. >> CAROLYN? >> I ALSO WANT TO THANK YOU FOR MOVING THIS FORWARD. IT REALLY IS VERY EXCITING. I UNDERSTAND IT'S A WORK IN PROGRESS, SO MY QUESTION IS, WHO ARE THE RESEARCHERS THAT YOU IDENTIFIED IN THAT BOX AS INDIVIDUALS WHO WOULD HAVE ACCESS TO THESE DATA? >> SO THERE WILL BE ROLE-BASED ACCESS, SO FOR SOME LEVEL OF DATA, WE HOPE TO HAVE IT JUST COMPLETELY FREELY AVAILABLE TO ANYBODY WITH AN INTERNET CONNECTION ESSENTIALLY. THEN THERE WILL BE OTHER LEVELS THAT WILL HAVE MORE SENSITIVE INFORMATION OR IDENTIFIABLE INFORMATION IN WHICH YOU WOULD NEED TO BE A QUALIFIED RESEARCHER, BUT A QUALIFIED RESEARCHER CAN BE ANY RESEARCHER. SO WE'RE NOT GOING TO HAVE RESTRICTIONS ON WHAT KINDS OF RESEARCHERS CAN HAVE ACCESS. WAS THERE A BURIED QUESTION IN THERE SOMEWHERE? >> WELL, I'M WONDERING ABOUT IRB APPROVAL AND THE KINDS OF THINGS THAT WOULD MONITOR THE USE OF THESE KIND OF DATA SO THAT IT'S USED IN A PRODUCTIVE WAY. >> GREAT. SO THERE'S TWO PARTS OF THAT. SO THE IRB IS GOING TO AB SINGLE PMI IRB, AND IT'S BEING BUILT RIGHT NOW IN THIS BUILDING, AND I'M PRETTY EXCITED ABOUT IT. IT'S GOING TO NOT LOOK LIKE YOUR GRANDFATHER'S IRB. INTERESTING CONVERSATIONS ARE HAPPENING ABOUT WHAT WE'RE -- IT'S TYPICAL ONLY TO HAVE ONE LAY REPRESENTATIVE ON AN IRB AND THERE MAY ACTUALLY BE CAPS ON THE NUMBER OF PARTICIPANT REPRESENTATIVES WHO CAN BE ON AN IRB, SO WE WILL BE HERE MUCH LIKE THE CENTRALIZED CANCER IRB, AND PEOPLE WILL BE ALLOWED TO PROVIDE BROAD CONSENT FOR SUBSEQUENT USE OF THEIR DATA AND SPECIMENS AND SPECIFIC CONSENT FOR THE RESEARCH THAT'S GOING TO GO ON CENTRALLY WITHIN PMI, SO PEOPLE SHOULD BE ABLE TO GET ACCESS TO SOME OF THESE DATA AND BIOSPECIMENS WITHOUT GOING BACK FOR EVERY SINGLE SUBSTUDY AND ASKING FOR PERMISSION. IMPORTANTLY, WHEN PEOPLE ACCESS THIS INFORMATION, THEY WILL HAVE TO AGREE TO IT -- SECURITY PRINCIPLES NOT UNLIKE WHAT HAPPENS WHEN YOU GET DATA FROM DB GAP PRESENTLY, BUT THE CHALLENGE THAT WE'VE HAD IS THAT A LOT OF THE RESEARCHERS THAT WE'D LIKE TO ENABLE ACCESS, WE DON'T HAVE A CONNECTION TO. RIGHT NOW NIH EXERTS A LOT OF ITS INFLUENCE, BECAUSE MOST RESEARCHERS ARE RETURN CUSTOMERS, SO YOU BEHAVE BECAUSE YOU WANT TO BE TREATED WELL WHEN YOU COME BACK AGAIN, AND SO IF THERE ARE PEOPLE WHO ARE GETTING ACCESS TO THIS WHO ARE NOT OUR CONSTITUENCY, THEN WHAT ARE THE MECHANISMS FOR BEING ABLE TO MAKE SURE THAT YOU HAVE ENFORCEMENT. SO WE'RE ACTUALLY PROPOSING SOME POLICY CHANGES AND LEGISLATIVE CHANGES SO THAT THERE WILL BE PENALTIES FOR PEOPLE WHO MISUSE INFORMATION WITHIN THE COHORT. THOSE ARE NOT YET IN PLACE, BUT WE ARE HOPEFUL THAT WE'LL HAVE SOME STRONG SUPPORT FOR THAT. THERE'S BEEN REALLY STRONG SUPPORT BOTH IN THE APPROPRIATIONS COMMITTEE AND THE AUTHORIZING COMMITTEE FOR THE COHORT SO WE'LL BE ABLE TO PUT THOSE IN PLACE. I HOPE I ANSWERED YOUR QUESTION. >> SO ONE SECOND. VALERIE? >> SO FIRST OF ALL, WE ARE ALL EXCITED ABOUT THIS, AND VI TWO SORT OF QUESTIONS OR THOUGHTS. YOU KNOW, WE'VE SEEN SOME OF THESE NATIONAL COHORT STUDIES TO BE ATTEMPTED LIKE THE NATIONAL CHILDREN'S STUDY, SO WHAT HAVE WE LEARNED FROM THOSE STUDIES THAT HAVEN'T GIVEN US, I THINK, THE RETURN THAT WE WERE EXPECTING ON THE INVESTMENT, AND THEN SECONDLY, CLEARLY THIS GROUP IS VERY, VERY INTERESTED IN THE ENGAGEMENT OF DIVERSE POPULATIONS TO BE INCLUDED, AND YOU'RE WELL AWARE OF THE CHALLENGES THAT WE HAVE ALWAYS HAD ABOUT ENROLLING DIVERSE SUBJECTS INTO ANY TYPE OF DATABASE, SO AS A LONG TERM RESEARCHER WHO'S HAD A LOT OF SUCCESS WITH ENROLLING DIVERSE POPULATIONS, ONE OF THE MOST IMPORTANT THINGS THAT YOU CAN DO IS TO HAVE THE FIRST POINT OF CONTACT BE SOMEBODY THAT LOOKS LIKE THE PERSON YOU'RE TRYING TO ENROLL. SO WHAT ARE THE PLANS FOR THAT? >> SO EMERGING, YEARS AGO WHEN FRANCIS HAD THE FIRST IDEA ABOUT DOING THE BIG COHORT STUDY, I WAS ACTUALLY AT HOPKINS AT THE TIME AND I ENDED UP APPLYING FOR AND GETTING A GRANT TO LOOK AT PUBLIC ATTITUDES ABOUT PARTICIPATING IN SUCH A COHORT, SO WE DID INTERVIEWS AND FOCUS GROUPS AND SURVEYS AND THE LIKE, AND ONE OF THE THINGS THAT WE HEARD A LOT ABOUT PEOPLE'S CONCERNS ABOUT PARTICIPATING IN A STUDY THAT LOOKS LIKE THIS STUDY WAS A CONCERN THAT THERE WAS ACTUALLY AN INTERVENTION SOMEWHERE, THAT THERE WOULD BE A DRUG, AN EXPERIMENTAL DRUG OR EXPERIMENTAL INTERVENTION. I THINK IT'S SOMETHING WE'RE GOING TO HAVE TO KEEP IN MIND WHEN WE TALK ABOUT THE STUDY, IS THAT IT REALLY IS AN OBSERVATIONAL LONGITUDINAL STUDY, SO WE'RE COLLECTING INFORMATION BUT WE'RE NOT ADMINISTERING ANY EXPERIMENTAL AGENTS TO PEOPLE, ALTHOUGH THEY MAY BE ABLE TO PARTICIPATE AND VOLUNTEER FOR CLINICAL TRIALS AS A PART OF THIS, BUT IT'S NOT CORE. THE THING IN TERMS OF DIVERSE COMMUNITIES, I THINK WE'RE GOING TO HAVE TO DO BOTH A TOP-DOWN COMMUNITY LEADER ENGAGEMENT AS WELL AS IN THE GRASS ROOTS. AND WE STARTED TO HAVE CONVERSATIONS WITH COMMUNITY LEADERS IN ORDER TO TRY TO HELP FIGURE OUT WAYS IN WHICH WE CAN GET THEIR PARTICIPATION EARLY ON. SO RATHER THAN BEING DISEASE-FOCUSED, IT'S REALLY GOING TO HAVE TO BE COMMUNITY-FOCUSED, BECAUSE THIS COHORT ISN'T ABOUT JUST RECRUITING PEOPLE WHO ARE PRESENTLY SICK. IT'S ABOUT RECRUITING A LARGE GROUP OF PEOPLE WHO MAY, OVER THE COURSE OF TIME OF THEIR PARTICIPATION, BECOME SICK. SO WE'RE STILL VERY MUCH IN THE EARLY STAGES, REACHING OUT TO PEOPLE WHO HAVE EXPERTISE IN THIS ARENA, AND WE'LL BE PUTTING OUT SOLICITATIONS SPECIFICALLY TO ASK PEOPLE FOR THIS -- BUILDING THIS PART OF IT. >> ONE OF THE THINGS YOU HAVE IS A NETWORK ALREADY, SO I KNOW IT'S CHANGED SOMEWHAT, BUT WHEN WE FIRST STARTED DOING CTSAs, WE ALL HAD TO HAVE THESE COMMUNITY ENGAGEMENT CORES, AND THEN, OF COURSE, THEY'RE SORT OF TO DILUTE -- BE DILUTED OVER THE YEARS. I GUESS IT STILL EXISTS AND I HAVEN'T BEEN ON A REVIEW PANEL FOR A WHILE, BUT IT'S DILUTED FOR SURE. SO MY CONCERN IS THAT WE DON'T -- WE ALWAYS START OUT WITH THIS BANG OF EVERYBODY -- IF YOU ASK A PERSON A QUESTION, EVERYBODY IS GOING TO SAY OF COURSE WE WANT TO HAVE A DIVERSE POPULATION, OF COURSE WE WOULD ENROLL THE RIGHT PEOPLE, OF COURSE. BUT THEN OVER TIME, WHAT WE SEE IS THE DILUTION EFFECT OCCUR AND PEOPLE FORGET WHAT THE REAL INTENT WAS. THAT'S SOMETHING I THINK YOU'VE GOT TO BE VERY CLEAR ABOUT. >> THE CTSA MODEL -- THE WAY TO GO HERE, HAVING ACADEMIC MEDICAL INSTITUTIONS AS BEING THE -- IS NOT NECESSARILY THE BEST WAY TO GET COMMUNITIES TO PARTICIPATE IN STUFF. SO THEY MAY BE A VOICE BUT THEY ARE CERTAINLY NOT THE ONLY VOICE. I ALSO WANT TO ANSWER YOUR QUESTION ABOUT THE CHILDREN'S STUDY. SO WE IT DID LEARN SOME REALLY INTERESTING LESSONS FROM THE CHILDREN'S STUDY, SO THE CHILDREN'S STUDY WAS TERMINATED PROBABLY ALMOST A YEAR AGO NOW BASED ON ITS FAILURES TO PRODUCE FOR THE MONEY THAT WAS BEING INVESTED. AND ONE OF THE THINGS THAT WE LEARNED ABOUT THAT, FROM THAT AND HAVE BEEN REALLY AIDED BY DAVID MURRAY, COLLEAGUE OF JANINE'S, AND THE ASSOCIATE DIRECTOR I FOR PREVENTION RESEARCH WHO HAS HELPED US NOW IN REALLY DOING A RETROSPECTIVE ANALYSIS OF THE CHILDREN'S STUDY, ONE OF THE THINGS THAT WE LEARNED IS THAT THEY BECAME VERY RIGID EARLY ON, AND IT WAS FUNDED ALMOST ENTIRELY BY FUNDING MECHANISMS THAT DIDN'T ALLOW US TO REALLY DRAW ON THE EXPERTISE OF THE INDIVIDUALS WHO WERE BEING FUNDED, AND THE P.I. WAS HERE RATHER THAN OUT IN THE -- OUT AS A PART OF THE COMMUNITY. SO THERE WAS A NUMBER OF AREAS WHERE THE CHILDREN'S STUDY FAILED AND WHERE WE HAVE TRIED TO LEARN FROM THOSE MISTAKES AND ALSO LOOKING TO OTHER COHORTS THAT HAVE BEEN MORE SUCCESSFUL, SO THE WOMEN'S HEALTH INITIATIVE, FRAMINGHAM, JACKSON HART STUDY, THE U.K. BIOBANK, THERE'S A CANADIAN COHORT, SO THERE'S A NUMBER OF COHORTS OF MORE LOCAL, MORE NATIONAL SCALE WHERE WE REALLY CAN LOOK TO FOR INSIGHTS. >> SO I AGREE WITH YOU THAT ACADEMIC HEALTH CENTERS ARE NOT THE WAY TO GO. THAT WAS MY POINT. THAT IS ACTUALLY NOT THE WAY TO GO. IF YOU REALLY WANT TO GET THE INCLUSION OF THOSE PERSONS WHO ARE NOT ALREADY SICK, OKAY, TO BE ABLE TO FOLLOW COHORTS, SO I HOPE THAT -- LIKE YOU SAID, WE'VE LEARNED AND WE DO HAVE SOME COHORTS THAT HAVE STARTED THAT ACADEMIC -- BUT SOMEHOW THEY'VE BEEN ABLE TO PUT THEIR TENTACLES OUT THERE TO ENGAGE THE COMMUNITY SO I THINK WE SHOULD LEARN FROM THOSE BECAUSE I DO THINK AK IT DEMIC -- TO BE A PART OF IT, WE SHOULD NOT BE THE PRIMARY SOLUTION. >> YES. THIS IS AN AREA WHERE I THINK WE CAN REALLY BENEFIT FROM THE WHITE HOUSE'S ENGAGEMENT AND EXPERTISE HERE BECAUSE THEY HAVE A BROADER REACH. AT NIH, WE'RE SPECIFICALLY FOCUSED ON -- OUR INSTITUTES AND CENTERS FOCUSED ON SPECIFIC DISEASES AND SPECIFIC INSTITUTIONS. SO ZOOMING UP A LITTLE BIT TO COMMUNITY AND COMMUNITY LEADERS AS ONE STARTING POINT. >> DR. BERG? >> I'M REALLY EXCITEED ABOUT THIS, BUT I THINK THAT THERE'S SOME CHALLENGES YOU'RE GOING TO FACE IN BALANCING A VOLUNTEER COHORT, AND THE FACT THAT THERE WILL BE REAL DIFFERENCES ACROSS DEMOGRAPHIC GROUPS SEEKING OUT AND BEING INVOLVED IN THAT. IT MAY TAKE HAVING SOME PARAMETERS UP FRONT. AS TO WHEN YOU HAVE ENOUGH OF A SPECIFIC GROUP AND HOW YOU'RE GOING TO REACH BEYOND THAT SO IT KEEPS MOVING AND VOLUNTEER DOESN'T START TO OUTWEIGH DIVERSITY THAT IS BOTH IN TERMS OF A CROSS RACIAL ETHNIC GROUPS, AND IDEALLY ECONOMIC DIVERSITY AS WELL. BUT ALSO GEOGRAPHIC DIVERSITY AMONG THE RAISHT ETHNIC MINORITY POPULATIONS. ULTIMATELY IN THE WOMEN'S HEALTH INITIATIVE, WE GOT ENOUGH MINORITY POPULATIONS OR WHAT ULTIMATELY TENDED TO BE A STRENGTH IN HAVING A REASONABLE REPRESENTATION, OUT OF FOCUSING IN A FUJI GRAPHIC AREAS TO ADD IN PEOPLE AND SO YOU LOSE THE DIVERSITY OF EXPERIENCES, THEY'RE NOT REPRESENTATIVE OF THE RANGE OF LIVES AND SO ON OF THE WOMEN IN THE STUDY. SO IT SEEMS LIKE IF THAT'S GOING TO TAKE A LOT OF PLANNING AND UNDERSTANDING, PARTICULARLY WITH INVOLVEMENT OF THE WHITE HOUSE WHEN THEY SAY THIS CELL IS FILLED OR WE NEED A CERTAIN PROPORTION THAT WOULD NOT COME FROM VOLUNTEER AND NOT ONLY DO WE HAVE A DIFFERENCE IN WHO AGREES TO BE IN A STUDY AND WHO DECLINES, BUT WE CERTAINLY HAVE A DIFFERENCE ON WHO VOLUNTEERS TO GO BE IN A STUDY. >> IT'S A REALLY GOOD POINT AND IS A SIGNIFICANT CHALLENGE. IN SOME WAYS, I THINK THE EARLY DAYS OF THIS PROGRAM ARE GOING TO BE REALLY A VERY INTERESTING EXPERIMENT IN PARTICIPANT ENGAGEMENT. THE QUESTION OF HOW TO ANTICIPATE WHETHER WE HAVE A WHOLE SLEW OF A CERTAIN KIND OF PEOPLE WHO SIGN UP AT THE BEGINNING, WHETHER OR NOT WE SHOULD HAVE SOME ALLOCATIONS THAT -- EVEN THOUGH WE'RE NOT SEEKING A STATISTICALLY REPRESENTATIVE SAMPLE, HAVE SOME ALLOCATIONS THAT ARE MADE, OUR SURVEY, WHICH THEY DIDN'T SHOW ANY OF THE DATA FROM THE SURVEY, SHOWED THAT THE FOLKS ACROSS ALL RACIAL AND ETHNIC GROUPS WERE STATISTICALLY UNDIFFERENTIATED IN TERMS OF THEIR INTERESTS IN THE STUDY, THEIR PERCEIVED INTEREST IN PARTICIPATING THE KINDS OF THINGS THAT THEY SAW AS INTERESTING AND EXCITING AND ALSO SCARY ABOUT IT, SO THERE WAS REALLY -- WHERE WE REALLY SAW PRETTY BIG DIFFERENCES WAS BY AGE AND PARTICULARLY AMONG OLDER AMERICANS, OH SO WE HAVE TO -- SPECIAL CONSIDERATIONS HAVE ASKED. SO I THINK THIS WILL BE AN INTERESTING EXPERIMENT AND PARTICIPANT ENDPAIJMENT AND WE HAVE NOT YET FIGURED OUT EXACTLY HOW WE'RE GOING TO PLAN FOR A SURGE POTENTIALLY FROM A PARTICULAR DEMOGRAPHIC GROUP AND RETICENCE FROM OTHERS, WE'VE GOT OUTREACH GOING ON, VOLUNTEERS FOR BROAD DIFFERENT COMMUNITIES AT THE BEGINNING. THE CANCER PRECISION MEDICINE INITIATIVE HAS SET ASIDE A SET OF PLOTS IN THEIR STUDY FOR RARE CANCERS, ANTICIPATING THAT THEY COULD FILL UP ALL OF THE SLOTS THAT THEY HAVE AVAILABLE WITH BREAST AND LUNG CANCER AND NOT WANTING TO IT B DO THAT, SO -- TO MAKE SURE WE END UP WITH AMPLE DIFFERENCES. >> BEING MINDFUL OR TRYING TO MONITOR FROM EARLY DAYS, WHETHER SOME DISEASE RELATED GROUPS HAVE A FOCUS AND HAVE DECIDED THAT'S A WAY TO GET ON THE RADAR, THIS IS THE WAY TO GET IN. THAT COULD BE EITHER THROUGH PEOPLE WHO ARE ALREADY EXPERIENCING AN ILLNESS OR THROUGH WOMEN AND FAMILIES THAT HAVE HIGH BREAST CANCER RATES OR SOMETHING. SIMPLY WANTING TO BE ENGAGED BUT THERE MAY BE A NUMBER OF DIFFERENT WAYS THAT THE ORGANIZED INTERESTS OF OTHER PEOPLE PLAYS OUT IN HIS VOLUNTEERING THROUGH THE STRENGTH OF NETWORK TIES AND OTHER THINGS. >> AND I APPRECIATE YOUR THOUGHT AND THAT OF OTHERS ABOUT THIS. I HAVE -- I HAVE VERY MIXED FEELINGS ABOUT THIS ISSUE AND THE NIH INSTITUTE AND CENTER DIRECTORS WHO MET TALKED ABOUT THIS. ON THE ONE HAND, YOU KNOW, ESPECIALLY FOR RARE DISEASES, THERE IS LIKELY NOT AS MUCH BENEFIT FOR A RARE DISEASE FROM THIS COHORT STUDY, AS THERE MIGHT BE FOR OTHER KINDS OF HEALTH OUTCOMES, AND YET THERE HAS BEEN SOME SIGNIFICANT ENTHUSIASM AMONG SOME OF THE MORE ACTIVE RARE DISEASE GROUPS, IF PEOPLE HAVE SORT OF LIKE -- ARMY OF WOMEN, IF PEOPLE GENERATE A CAMPAIGN AND SIGN UP ON THE ONE HAND, HOORAY PEOPLE ARE SIGNING UP AND WE WANT PEOPLE TO BE EXCITED AND INTERESTED AND ENGAGED. ON THE OTHER HAND, WAIT A MINUTE, WE WANT TO HAVE SOME BALANCE BETWEEN FOLKS WHO WALK IN THE DOOR -- DISEASES AND CONDITIONS AND PEOPLE WHO EXPERIENCE THOSE OVER TIME. SO IT'S A CHALLENGE AND I DON'T KNOW THAT WE HAVE THE RIGHT ANSWER YET. SO I'D APPRECIATE ANY -- >> YOU CAN RUN THE WHOLE GAMUT TO SAYING THAT THERE'S A PORTION OF THE COHORT THAT YOU WANT TO SET ASIDE AND DO A REPRESENTATIVE SAMPLE AND YOU'D BE ABLE TO DO COMPARISONS OF THE EXTENT TO WHICH THERE ARE DIFFERENCES ON DEMOGRAPHICS OR DOING PROPENSITY SCORING TO TRY TO UNDERSTAND HOW IT MAY OR MAY NOT IMPACT SOME KINDS OF FINDINGS. IT'S NOT GOING TO BE PERFECT, BUT THAT'S WHERE I'M THINKING THAT SOME OF THE PLANNING NOW HAS TO FIGURE OUT WHAT YOU'RE GOING TO DO BECAUSE JUST SAYING, WELL, WE'LL JUST HAVE A MOVING TARGET AND IF WE'RE GETTING ONE KIND OF MIX, WE'LL USE THE OTHER, ONE IS YING, ONE IS YANG, WE'LL CREATE BALANCE THAT WAY, YOU MAY REALIZE AT A SERP POINT YOU MISSED A CHANCE TO DO SOMETHING WHERE YOU CAN AT LEAST TRY TO COMPARE. >> YES. THE OTHER THING WE FOCUSED A LOT OF OUR CONVERSATION ON, ANYBODY ANYWHERE CAN RAISE THEIR HAND, BUT KEEP IN MIND THAT WE HAVE THE HEALTHCARE PROVIDER ORGANIZATIONS WHO WILL BE ABLE TO RECRUIT -- INVITE PEOPLE TO VOLUNTEER IN A VERY PREDICTABLE WAY, SO THE NUMBER OF PEOPLE AND THE KINDS OF PEOPLE THAT THEY WILL BE ABLE TO RECRUIT FROM WITHIN THEIR PATIENT POPULATIONS IS ACTUALLY MUCH MORE PREDICTABLE AT THE OUTSET, SO NOT TO FORGET THAT AS WELL. THERE'S DIFFERENT VIEWS OF ABOUT WHAT PROPORTION OF THE COHORT SHOULD BE COMPRISED OF PEOPLE FROM WITHIN THE HEALTHCARE PROVIDER ORGANIZATION VERSUS DIRECT TO VOLUNTEERS, SO WE'RE -- AS I SAID -- >> IT'S NOT THAT THEY'RE RIGHT ANSWERS. IT'S JUST THEIR THERE ARE IMPLICATIONS. >> CARMEN, ONE LAST QUESTION. LAST QUESTION. >> THIS IS MORE OF A COMMENT. >> OKAY. >> THANK YOU FOR THE PRESENTATION. I WANT TO REITERATE SOME OF THE COMMENTS THAT MY COLLEAGUE, DR. MONTGOMERY RICE MENTIONED, WHICH IS ABOUT THE WHOLE CONVERSATION REGARDING DIVERSITY AND DISPARITIES. FOR INSTANCE, WHEN I LOOK UP THERE, WE TALK ABOUT WOMEN AND NOW WE HAVE INCREASING INTEREST IN PEOPLE WHO ARE TRANSGENDERED OR -- QUESTIONING, AND SO WE NEED TO MAKE CERTAIN THAT WE PAY VERY CLOSE ATTENTION TO EMERGING CONVERSATIONS THAT ARE GOING ON IN THIS COUNTRY. I'M JUST TOUCHING ON THAT. LGBT CARE, LOTS OF ISSUES THAT ARE THERE. THE OTHER THING IS I WOULD DISAGREE, I'M NOT CERTAIN THAT THE CTSAs HAVE BEEN THE BEST VABL FOR COMMUNITY ENGAGEMENT. I THINK THAT WHENEVER WE THINK ABOUT COMMUNITY ENGAGE IN THE A WORTHWHILE FASHION, I THINK ABOUT THE RICKMARS, THOSE ARE AREAS WHICH ENDS UP OFTEN THEIR BUDGETS GET CUT. AND YET THE MODEL HAS WORKED AND YOU HAVE SIX CENTERS OF EXCELLENCE FOR ALMOST 20 YEARS NOW. AND SO THEY'VE DRIVEN HIGHLY AND IMPACTED BY THE COMMUNITY ADVISORY BOARD, AND I JUST DIDN'T SEE THAT COMING THROUGH, THAT THERE WAS A COMMUNITY ADVISORY BOARD, SO THINKING ABOUT THE SCIENCE, AND CLEARLY WE GET MUCH BETTER, HIGHER QUALITY SCIENCE FROM THE COMMUNITIES INVOLVED FROM THE VERY BEGINNING OF THESE PRECISION -- SO I WOULD ENCOURAGE US TO THINK ABOUT INCORPORATING THAT VERY, VERY EARLY. THE OTHER THING I THINK ABOUT ARE THE PEOPLE WHO DON'T SEEK HEALTHCARE WHO ARE PATIENTS, SO I JUST GOT FINISHED IN THE -- ENCEPHALITIS, THOSE ARE PEOPLE WHO ARE PATIENTS WHO WON'T NECESSARILY VOLUNTEER. SO IT'S NOT NECESSARILY A RARE DISEASE. I WOULD THINK ABOUT THOSE TYPES OF LIMITATIONS FOR PEOPLE. I JUST REALLY WANT TO HIT THE POINT THAT THERE HAS BEEN A HISTORY IN WHICH RACIAL AND ETHNIC MINORITIES HAVE NOT PARTICIPATED, THEY'VE NOT VOLUNTEERED. WHEN THEY DO VOLUNTEER, THEY'VE NOT GOTTEN THE BENEFITS FROM THE SCIENCE. AND SO THAT REALLY NEEDS TO BE THOUGHT ABOUT IN A VERY CAREFUL WAY. PARTICULARLY IN A SOCIETY THAT'S INCREASINGLY DIVERSIFYING. AND WE WILL BE -- PEOPLE OF COLOR WILL BE THE MAJORITY POPULATION VERY SOON. SO THAT ALSO BRINGS THE QUESTION OF WHAT DO YOU CALL PEOPLE WHEN THEY FIT INTO MORE THAN ONE CATEGORY. AND THOSE TYPES OF CONVERSATIONS STILL HAVE NOT BEEN -- WE'VE NOT COME TO SOLUTIONS ON THAT. >> I APPRECIATE THAT. THERE WAS -- WE HAD AN ENTIRE -- ONE OF THE FOUR WORKSHOPS WAS SPECIFICALLY ON COMMUNITY ENGAGEMENT AND PARTICIPANT ENGAGEMENT, AND WE HAD FOLKS ON THE WORKING GROUP INCLUDING SHARIKI, ESTABON, SPIRO FROM NATIVE POPULATIONS, SWOA HAD PEOPLE FOCUSING ESPECIALLY ON THOSE ISSUES AND WE HAD VERY INTERESTING AND ANIMATED CONVERSATIONS ABOUT THIS ISSUE OF DO YOU HAVE THE PEOPLE WHO ARE FOCUSED ON ENGAGEMENT AND SPECIFICALLY ENGAGEMENT OF DIVERSE POPULATIONS IN A SEPARATE GROUP AND THE MAIN ADVISORY GROUP BEING OVER HERE, OR DO YOU MAKE SURE THAT THEY ARE AT THE TABLE. WE ENDED UP COMING TO THE CONCLUSION THAT THEY NEEDED TO BE AT THE TABLE, WHICH IS WHY THE OVERREPRESENTATION OF FOLKS ON THE IRB, OVERREPRESENTATION OF PEOPLE WITH COMMUNITY AND ENGAGEMENT EXPERTISE ON THIS ADVISORY BOARD THAT WE'RE GOING TO BE ANNOUNCING THE MEMBERS UP SOON -- -- THE WORKING GROUP PLAN. SO I THINK IT'S BEEN INCLUDED ALL ALONG BUT IT WAS A VERY INTERESTING AND RECURRING THEME OF WHETHER OR NOT YOU HAVE A SEPARATE GROUP THAT IS A COMMUNITY ENGAGEMENT GROUP AND THEN THERE IS THE MAIN GOVERNANCE GROUP, AND WE OPTED NOT TO HAVE A SEPARATE GROUP FOR THAT FUNCTION. >> AND SO WHO AM I TO DISREGARD OR DISPUTE SPIRO? BUT AGAIN, I WOULD SAY THAT IT'S IMPORTANT -- SO WE'RE ALSO TALKING ABOUT THE PEOPLE WHO ARE INTELLECTUALS IN THE FIELD AND NOT THE PEOPLE AT THE COMMUNITY LEVEL. AND WHEN WE TALK ABOUT COMMUNITY ENGAGEMENT, MY VERSION, MY DEFINITION OF COMMUNITY ENGAGEMENT AS RELATES TO HEALTH DISPARITIES ARE KIND OF THE SAME BUT VERY DIFFERENT, AND SO I THINK THAT YOU IT -- WHAT I MEAN BY -- SO WE'D GO OUT AND SO LET'S GET PEOPLE FROM THE DISABILITY GROUPS, AMERICANS FOR DISABILITIES, BUT THERE MAY NOT BE THE SAME PEOPLE WHO ARE STRUGGLING, WHO HAVE -- OTHER PEOPLE MAY NOT HAVE THE TIME OR THE INTEREST TO PARTICIPATE. AND HOW ARE THOSE PATIENTS, THOSE PEOPLE, DIFFERENT FROM THE PEOPLE THAT WE REALLY NEED TO ACTUALLY GET INFORMATION FROM. AND THERE ARE WAYS IN WHICH YOU CAN DO THAT. I MEAN, WE'VE DONE THAT WITHIN THE MICHIGAN CENTER FOR AFRICAN-AMERICAN AGING RESEARCH, WE'VE DONE THAT, WE'VE SORT OF SAID, OKAY, THESE ARE PEOPLE WHO ARE MEMBERS OF OUR COMMUNITY ADVISORY BOARD, THESE ARE PEOPLE WHO WE'RE SERVING, HOW DOES THIS LOOK LIKE IN COMPARISON TO THE REST OF DETROIT, FOR INSTANCE. >> SO LOOKING AT HOW WELL WE'VE DONE HISTORICALLY ON THIS ISSUE OF ENGAGING AND -- WE HAVEN'T DONE GREAT YET. SO THERE'S SOME GOOD MODELS OUT THERE BUT WE ALSO HAVEN'T YET FOUND THE IDEAL WAY OF GETTING MULTIPLE DIVERSE COMMUNITIES ENGAGED IN PARTICIPATING ACTIVELY OVER TIME IN RESEARCH, WE HAVE NOT YET FOUND THE SECRET AND SO I LOOK FORWARD TO WORKING WITH YOU AND OTHERS AND I NOTED DOWN THE GROUP THAT YOU MENTIONED AND WE'LL CERTAINLY LOOK TO THOSE FOR MODELS OF HOW TO MAKE THIS WORK, AND IF YOU LOOK AT RECRUITMENT AND RETENTION AND RESEARCH ACROSS THE BOARD, WE DO -- AT THIS. SO WE'VE GOT TO DO STUFF A LITTLE BIT DIFFERENT AND FIND SOME NEW MORE EFFECTIVE TECHNIQUES. >> THANK YOU, EVERYBODY. I WANT TO MAKE SURE YOU GET YOUR BREAK. THANK YOU VERY MUCH, DR. HUDSON. [APPLAUSE] SO WE'LL BE ON BREAK UNTIL 11:00 SO SEE YOU AT 11:00. WE'RE GOING TO RECONVENE SO WE'RE BACK ON, AND I'D LIKE TO INTRODUCE DR. JULIEANN TO LEAD US OFF. >> I'M REALLY PLEASED THIS MORNING TO BE ABLE TO INTRODUCE ADRIENNE HALLETT, THE NEW ASSOCIATE DIRECTOR FOR THE OFFICE OF LEGISLATIVE POLICY AND ANALYSIS HERE AT NIH. ADRIENNE ARRIVED AT NIH IN MAY OF THIS YEAR AFTER 15 YEARS IN THE U.S. SENATE. SO PRIOR TO ARRIVAL AT NIH, MS. HALLETT WAS A SENIOR POLICY ADVISOR ON THE SENATE APPROPRIATIONS COMMITTEE, AND SHE ALSO SERVED AS STAFF DIRECTOR OF THE APPROPRIATIONS SUBCOMMITTEE ON LABOR HHS AND EDUCATION, WHICH OVERSEES THE NEGOTIATION OF BUDGETS FOR THREE CABINET AGENCIES AND 14 RELATED AGENCY BOARDS AND COMMISSIONS. SO ADRIENNE BRINGS A WEALTH OF EXPERIENCE TO NIH AND WE'RE VERY PLEASED TO HAVE HER HERE TODAY. SHE'S GOING TO SHARE HER PERSPECTIVE ON CHANGES IN CONGRESS AND PROPOSED LEGISLATION RELATED TO NIH. SO PLEASE GIVE HER WARM WELCOME. [APPLAUSE] >> I THINK MY CHIEF OBJECTIVE WHY NIH REALLY LIKES HAVING ME HERE IS THAT I SHARE ALL THE GOSSIP FROM THE STAFF ABOUT WHAT'S GOING ON IN THE SPEAKER'S RACE, WHAT'S GOING ON -- SO THANK YOU SO MUCH FOR HAVING ME HERE. THIS IS A REALLY IMPORTANT OFFICE AND IMPORTANT GROUP FOR CONGRESS, SO SEEING ALL OF YOU AND YOUR STAKEHOLDERS HERE, IT'S A GREAT WAY FOR NIH TO MOVE FORWARD OUR MISSION, AND IT'S ALSO A WAY THAT PEOPLE IN CONGRESS AND PEOPLE IN THE PUBLIC HAVE THEIR EYE ON NIH, AND YOU ALL HAVE SUCH AN IMPORTANT ROLE TO PLAY IN MAKING SURE THAT WE STAY TRUE TO OUR MISSION AND MOVE FORWARD IN WAYS THAT ARE RESPONSIBLE AND APPROPRIATE, SO THANK YOU. I'M GOING TO TALK -- I DO WANT TO SAY AT THE OUTSET THAT WE'RE AT AN INTERESTING PLACE FOR BOTH NIH AND ORWH IN CONGRESS, AND THAT IS BECAUSE A LOT OF THE LEADERSHIP IN CONGRESS IS CHANGING. THEY'RE SORT OTHERE'S SORT OF A GENERATION SHIFT HAPPENING. SO AS YOU ALL PROBABLY KNOW, NIH'S APPROPRIATE TORES WERE THE LONGEST TIME WERE AR LAN INSPECTOR AND TOM HARKIN. WE NOW HAVE SOME WOMEN SENATORS WHO HAVE GAINED A LOT OF SENIORITY WHO HAVE BEEN INTERESTED IN WOMEN'S HEALTH FOR A VERY LONG TIME, WHO ARE REACHING POSITIONS OF REAL AUTHORITY. THEY ARE REACHING SOME COMMITTEE -- IMPORTANT COMMITTEE MILESTONES, SO WE NOW HAVE THE RANKING MEMBER OF THE ENTIRE APPROPRIATIONS COMMITTEE IS BARBARA MIKULSKI, THE RANKING MEMBER OF OUR AUTHORIZING COMMITTEE, THE HEALTH COMMITTEE IN THE SENATE, IS PATTY MURRAY. NOW PATTY MURRAY IS ALSO IN TWO OTHER LEADERSHIP POSITIONS THAT ARE REALLY INTERESTING. SHE'S THE RANKING MEMBER OF OUR APPROPRIATIONS SUBCOMMITTEE. JUST TOOK THAT OVER IN JANUARY. AND THOSE OF YOU WHO PAY ATTENTION TO POLITICS KNOW THAT HARRY REID HAS DECIDED TO STEP DOWN AS THE DEM KRA IK IT LEADER IN THE SENATE. CHUCK SCHUMER SAYS HE HAS THE VOTES TO REPLACE HIM, I BELIEVE, NO REASON NOT TO. SO THERE'S A LOT OF SPECULATION THAT PATTY MURRAY, WHO RIGHT NOW IS NUMBER THREE IN LEADERSHIP IN THE DEMOCRATIC SIDE OF THE SENATE, WILL BE MOVING UP TO NUMBER TWO. SO THESE WOMEN, TAMMY BALDWIN, WE HAVE A NUMBER, ELIZABETH WARREN, WE HAVE A NUMBER OF WOMEN GETTING INVOLVED IN HEALTH POLICY AND SH STATE HAVE STATED THAT THEY WANT TO BE CHAMPIONS FOR WOMEN'S HEALTH AND RESEARCH INTO WOMEN'S HEALTH. THEY'VE MADE IT A PRIORITY IN SOME OF THE LEGISLATION THAT I'M GOING TO TALK ABOUT. SO I JUST WANTED TO PUT THAT OUT THERE AS A CONTEXTUAL FRAMING FOR YOU. I THINK IT'S A GREAT OPPORTUNITY FOR NIH TO ENGAGE IN GOOD AND INTERESTING WAYS, BUT IT ALSO MEANS THAT BECAUSE A LOT OF THESE MEMBERS ARE NEWER TO THEIR ROLE, WE HAVE AN ENORMOUS AMOUNT OF EDUCATION TO DO. WE CAN'T RELY ON YEARS OF EXPERIENCE WITH US. WE NEED TO BE A LITTLE MORE PROACTIVE AND A LITTLE MORE OUTWARD FACING TO GET MORE AND MORE PEOPLE ON THE HILL FAMILIAR WITH AS WE CHANGE OVER, AS THE AVERAGE AMOUNT OF TIME FOR A STAFF MEMBER ON THE HILL SHRINKS. RIGHT NOW THE AVERAGE AMOUNT OF TIME THAT ANY STAFFER STAYS IN THEIR JOB ON THE HILL IS 18 MONTHS. SO MY OFFICE IN PARTICULAR IS PERENNIALLY EDUCATING THESE STAFF MEMBERS ABOUT WHAT WE DO AND WHY WE DO IT, SO WE APPRECIATE ALL OF YOUR HELP AND PARTICULARLY THE STAFF OF ORWH WHO EXPLAIN VERY COMPLICATED THINGS IN PLAIN LANGUAGE. SO WITH THAT, WE'LL MOVE INTO SOME OF THE DETAILS. SO THIS IS A LITTLE BIT WHAT I WAS TALKING ABOUT. WE HAVE -- ROY BLUNT IS NEW ON THE TOP RIGHT SIDE, TOM COLE IS NEW TO THE SUBCOMMITTEE CAN -- HE'S NOT NEW TO THE SUBCOMMITTEE, HE'S NEW TO THE CHAIRMAN'S ROLE. LAMAR ALEXANDER IS FAIRLY NEW. WE HAVE A LOT OF MEMBERS WHO ARE TURNING OVER AND GAINING NEW RESPONSIBILITY WITH RESPECT TO OUR ISSUES. THOSE ARE THE NEW MEMBERS, IN RED. 21ST CENTURY. SO OVER THE LAST TWO YEARS, YOU'VE PROBABLY BEEN HEARING A LOT ABOUT THE 21ST CENTURY CAROUSEL. THIS CAME OUT OF THE HOUSE. MR. UPTON ON THE HOUSE ENERGY AND COMMERCE COMMITTEE MADE A GOAL TO PUT OUT AN INNOVATION BILL, AND IT'S PREEML PRIMARILY NIH AND FDA FOCUSED. AS YOU SEE, AN OVERWHELMING MAJORITY, 344-77, VOTED FOR THIS BILL. THERE ARE A NUMBER OF THINGS IN THIS BILL FOR NIH. THE ONE THAT WE LIKE THE MOST OBVIOUSLY IS THE ONE THAT GIVES $8.75 BILLION OVER FIVE YEARS TO NIH. $1.75 BILLION A YEAR. THESE ARE THE THINGS THAT IT DOES. YOU CAN SORT OF READ THROUGH THAT YOURSELF. THERE'S ABOUT $300 MILLION THAT'S LEFT OVER ALL THAT NIH CAN SPEND IN WHATEVER WAY NIH -- THE OFFSET IS THE STRATEGIC RESERVE, A FEW CHANGES TO MEDICARE AND MEDICAID, NOT MANY. THE STRATEGIC PETROLEUM RESERVE, AS YOU SEE YOUR GAS PRICES GO DOWN, THE VALUE OF THIS RESERVE GOES DOWN AS WELL. SO THAT OFFSET MAY OR MAY NOT BE AVAILABLE. A COUPLE OTHER PROVISIONS, THERE'S A STRATEGIC PLAN, CREATES RENUB RENEWABLE TERMS FOR I.C. DIRECTORS. THERE ARE A COUPLE MEMBERS WHO ARE SPECIFICALLY VERY INTERESTED IN PRIZES. THEY LIKE THE IDEA OF PRIZE AUTHORITY, THEY'VE SEEN IT WORK IN OTHER AREAS OF SCIENCE. WE HAVE SOME CHALLENGES IN BIOMEDICAL SCIENCE ABOUT HOW PRIZES CAN REALLY BE EFFECTIVE, SO WE'RE WORKING ON THAT. ANOTHER BIG PRIORITY FOR NIH IS CONFERENCES. BOTH SCIENTIFIC TRAVEL TO CONFERENCES AND NIH SPONSORSHIP OF CONFERENCES. SO WE'RE MAKING PROGRESS, THERE ARE A NUMBER OF OUR CHAMPIONS ON THE HILL WHO WANT TO DO SOMETHING TO ELICIT SUPPORT FROM SCIENTIST ITS, AND I'M HOPEFUL WHEN THE SENATE BILL COMES OUT, THERE WILL BE ACTUAL LISTING OF THE LEGISLATION. IT'S A TRICKY THING TO DO BECAUSE THE LIMITATIONS COME MOSTLY FROM AN EXECUTIVE ORDER AND WE HAVE A SEPARATION OF POWER IN THIS COUNTRY, BETWEEN THE LEGISLATIVE AND EXECUTIVE BRANCH. THE LEGISLATIVE BRANCH CAN NOT TELL THE PRESIDENT WHAT TO DO WITH THE PEOPLE WHO WORK FOR HIM. OR THEY'RE NOT SUPPOSED TO, I SHOULD SAY IT THAT WAY. THERE'S A LOT OF INTEREST IN WHAT'S GOING ON IN SCIENTISTS' LIVES, BOTH HOW TO RECRUIT THEM THROUGH THE REPAYMENT PROGRAM, HOW TO DEAL WITH THE BABY BOOM GENERATION MOVING THROUGH THE SCIENTIFIC PIPELINE. SO HERE'S SORT OF WHAT'S GOING ON ON OUR AUTHORIZING SIDE. MR. UPTON REALLY WANTS TO MOVE THIS BILL. HE REALLY WANTS TO GET IT THROUGH AS SOON AS POSSIBLE. HE'S LOOKING AT 2016 AND SAYING, PRESIDENTIAL YEAR, WHO KNOWS HOW MUCH LEGISLATION IS GOING TO MOVE, HE'S BEEN PUSHING THE SENATE TO GET MOVING ON THIS BILL. BUT THE JURISDICTION, WHEN WE LOOK AT OUR AUTHORIZERS IN THE HOUSE, THERE'S AN ENERGY AND COMMERCE COMMITTEE, SO THEY'RE WORKING ON THIS BILL THE SAME TIME THEY'RE DOING THE VOLKSWAGEN INVESTIGATION. IN THE SENATE, IT'S HEALTH AND EDUCATION. SO SENATOR ALEXANDER, FORMER SECRETARY OF EDUCATION, PATTY MURRAY GOT INTO POLITICS BEING A SCHOOL BOARD MEMBER, THE FIRST THING THEY DID WHEN THEY CAME IN IN JANUARY WAS TRY TO MOVE SOME EARLY EDUCATION POLICY. SO THE COMPETING TIMETABLES IN THE HOUSE AND SENATE ARE DIFFERENT BASED ON THEIR JURISDICTION. SO THE SENATE, WE'VE NOT SEEN THEIR BILL YET, THEY HAVE NOT PUT ONE OUT. THEY DID HEARINGS, WE SPENT A LOT OF TIME WITH THEM EDUCATING, WE HAD A WHOLE BUNCH OF STAFF COME TO NIH TO LEARN ABOUT HOW WE DO. WE'RE HOPING, WE'RE EXPECTING THAT THEY'LL PUT OUT A DRAFT BILL, IT WAS SUPPOSED TO BE AUGUST, THEN IT WAS SUPPOSED TO BE SEPTEMBER, THEN WAS SUPPOSED TO BE OCTOBER. I DON'T THINK WE'RE GOING TO SEE IT UNTIL NOVEMBER OR DECEMBER. POSSIBLY COMMITTEE ACTION. WE'RE TEFL NO DEFINITELY NOT GOING TO SEE A FINAL BILL UNTIL NEXT YEAR, SO AS WE THINK ABOUT THE POSSIBILITY FOR MANDATORY FUNDING, IT'S GOING TO BE A 2016 AND 2017 CONVERSATION. SO THE ENERGY AND COMMERCE COMMITTEE WANTED A BROAD LOOK AT INNOVATION ACROSS NIH AND FDA TO THE HEALTH COMMITTEE HAS SIGNALED THEY WANT IT VERY MUCH MORE FOCUSED, BUT WHEN WE TALKED TO THE HOUSE ABOUT SPECIAL POPULATIONS, CONCERNS ABOUT WHO'S INVOLVED IN RESEARCH, WHO'S THE FOCUS OF THE RESULTS IN RESEARCH, THE HOUSE IS VERY CONCERNED ABOUT DIVERSITY IN TERMS OF AGE BRACKET. THEY WANT TO MAKE SURE THAT THE CHILDREN ARE INVOLVED IN RESEARCH THAT WERE GETTING BENEFIT FOR PEDIATRIC ISSUES AND SENIORS. IN THE SENATE, IT'S MUCH MORE FOCUSED ON MAKING SURE WE HAVE APPROPRIATE GOALS AND APPROPRIATE WAYS OF ACCOUNTING FOR HOW WE'RE DOING SCIENCE THAT BENEFITS WOMEN, THAT BENEFITS MINORITY POPULATIONS, THAT ACCOUNTS FOR THE DIVERSITY IN OUR COUNTRY. WE TALK ABOUT HOW RESEARCH IS BENEFITING AMERICANS AND ALSO HOW IT'S INVOLVING AMERICANS, THERE'S A LITTLE BIT OF A DISCONNECT IN WHAT YOU HEAR IN THE TWO BILL PROCESSES. SO WHEN WE GET TO CONFERENCE, IT'S GOING TO BE REALLY INTERESTING. SO IF YOU READ ANY NEWSPAPER IN AMERICA, WHAT THEY TELL YOU IS THAT CONGRESS HAS A LOT TO DO THIS FALL. MY GOAL IN EXPLAINING CONGRESS IS TO ACTUALLY NEVER PREDICT WHAT THEY'RE GOING TO DO, BUT IT'S TO HELP YOU READ YOUR NEWSPAPER, TO HELP YOU KNOW WHEN YOU'RE READING YOUR NEWSPAPER WHAT ON EARTH ARE THEY TALKING ABOUT? OCTOBER 29TH IS AN IMPORTANT DAY, THE DAY THAT JOHN BOEHNER INITIALLY SAID HE'S GOING TO HOLD HIS ELECTION FOR WHO'S GOING TO REPLACE HIM, AND IT'S THE DAY THAT THE HIGHWAY BILL PAYMENTS EXPIRE. IN THE SENATE, THE HIGHWAY BILL USES THE ENTIRE STRATEGIC RESERVE WHICH THE HOUSE USES FOR THE NIH MANDATORY FUND. YOU CAN SEE HERE THE GREEN IS WHERE BOTH CHAMBERS ARE IN SESSION. THE BLUE LAST WEEK, THEY WERE BOTH OUT FOR COLUMBUS DAY. SO WE'RE GETTING PRETTY CLOSE TO THAT DATE OF THE 29TH. WE'RE ALSO GETTING PRETTY CLOSE TO THE NOVEMBER 3RD DAY, WHEN TREASURY SAYS THAT WE'RE GOING TO REACH THE DEBT LIMIT. GOVERNMENT FUNDING EXPIRES ON DECEMBER 11TH, TAX -- A LOT OF THE R & D CREDITS AND A LOT OF OTHER TAX PROVISIONS EXPIRE ON THE 31ST. THERE ARE A NUMBER OF THINGS THAT HAVE TO HAPPEN, AND WHAT'S IMPORTANT OF THIS IS THAT EVERY SINGLE ONE OF THEM INVOLVES MONEY. EVERY SINGLE ONE OF THEM INVOLVES GETTING SOME KIND OF AN AGREEMENT ABOUT WHAT WE'RE GOING TO SPEND MONEY ON, HOW WE'RE GOING TO ACCOUNT FOR IT, AND WE -- OVER THE LAST THREE YEARS, THE CONGRESS HAS REALLY FOCUSED ON WHAT ARE THE OFFSETS THAT EVERYBODY CAN AGREE ON. THE LOW HANGING FRUIT IS GONE, THE CARRYOVER IN AGENCIES IS GONE, SO THESE ARE GOING TO BE SOME TOUGH AGREEMENTS, AND WE'RE SEEING PEOPLE TALK ABOUT THEM NOW. THERE'S A LOT OF AGREEMENT ON WHAT WE WANT TO SPEND MONEY ON. THERE'S NOT A LOT OF AGREEMENT ON WHERE IT SHOULD COME FROM. SO THOSE ARE KEY DATES THAT YOU WILL WANT TO WATCH OUT FOR AND KEY PRESSURE POINTS THAT ARE COMING. EARLIER IN OCTOBER WITH A BIG OPTIMIST ON THE OCTOBER DEAL, SENATOR MCCONNELL, WHO IS MAJORITY LEADER OF THE SENATE, AND CONGRESSMAN BOEHNER, THE SPEAKER OF THE HOUSE, HAS SAID THAT THEY WANT A DEAL AND THEY WANT A TWO-YEAR DEAL AND THERE'S GOOD REAP FOR THAT. THE TWO-YEAR DEAL WOULD GET THEM THROUGH THE ELECTION. SO NOBODY WANTS A SHUTDOWN ON SEPTEMBER 30TH OF AN ELECTION YEAR. WELL, NOBODY SHOULD WANT IT, EVER. BUT AN ELECTION YEAR IS PARTICULARLY DIFFICULT FOR THOSE WHO ARE INVESTED IN THE OUTCOMES OF THOSE ELECTIONS. SO THE GOAL, I THINK, OF BOTH PARTIES IN CONTROL, THE SENATE MAJORITY HAS A MAJORITY OF THE SEATS THAT ARE UP, 24 OF THESE SEATS THAT ARE UP IN 2016 ARE FROM THE MAJORITY PARTY IN THE SENATE. SO MR. MCCONNELL HAS GOOD REASON TO WANT A DEAL THAT STAVES OFF THE POSSIBILITY OF SHUT DOWN, FISCAL CLIFF, THROUGH NEXT YEAR. SO HERE'S HOPING THAT THAT PRESSURE CREATES THE OPPORTUNITY FOR SOME COMPROMISE WHERE WE COULD GET SOME STABILITY IN FUNDING. IT IF IT HAPPENS TO CREATE AN OPPORTUNITY FOR NIH, WELL, I MIGHT BE THERE TO TRY AND TAKE ADVANTAGE OF IT. WHAT ARE THEY FIGHTING ABOUT? SO EVERYBODY IN THIS ROOM I'M SURE HAS HEARD THE WORD SEQUESTER ONE TOO MANY TIMES. CERTAINLY I HAVE. BUT HERE ARE THE NUMBERS. SO THE BUDGET CONTROL ACT IN 2011 SEPARATED A FIREWALL BETWEEN SECURITY AND NON-SECURITY. SECURITY IS DIFFERENT THAN JUST DEFENSE. IT ALSO INCLUDES SOME THINGS IN MILITARY CO CONSTRUCTION, IT INCLUDES SOME THINGS IN THE DEPARTMENT OF ENERGY, SOME THINGS IN THE DEPARTMENT OF HOMELAND SECURITY. THESE ARE THE DIVISIONS THAT WE'RE WORKING ON RIGHT NOW. YOU CAN SEE IN FY15 THROUGH 16 NON-SECURITY FUNDING GOES UP, SO THIS IS THE CONVERSATION RIGHT NOW, ACROSS ALL OF NON-SECURITY, THAT'S TRANSPORTATION, THAT'S NATIONAL PARKS, THAT'S EDUCATION, WORKER PROTECTION PROGRAMS, IT'S EVERYTHING. SBY $1 BILLION. YOU'VE PROBABLY HEARD THAT NIH, THE PRESIDENT'S BUDGET, IS SEEKING A $1 BILLION INCREASE. BUT THEY DIDN'T CUT -- IF THEY DIDN'T CUT ANYTHING ELSE, WE WOULD GET ALL OF IT. BUT WE'RE COMPETING WITH EVERYTHING ELSE IN THE GOVERNMENT. IF -- SO THE PRESIDENT HAS SAID I WANT TO REPLACE SEQUESTER, THAT WOULD IT MEAN GOING FROM THIS 492 NUMBER IN FY15 TO THE 530 NUMBER. SO THE QUESTION, WHAT THEIR ARGUING ABOUT IS THAT DIFFERENCE, ARE WE GOING FROM 492 TO 493 OR FROM 492 TO 530? AND EVERYTHING YOU READ ABOUT, WHEN YOU READ ABOUT IS THE GOVERNMENT GOING TO DO MORE IN THIS AREA, IS THE GOVERNMENT GOING TO DO MORE IN THE SAFETY OF -- AS TRAINS GET DERAILED IN THE NORTHEAST CORRIDOR, ARE WE GOING TO DO MORE ON SAFETY, ARE WE GOING TO DO MORE FOR NIH, ARE WE GOING TO DO MORE IN EARLY CHILDHOOD EDUCATION? THE QUESTION IS GOING TO BE, ARE WE INCREASING OUR SPENDING BY A BILLION DOLLARS ACROSS NOBODY NON-SECURITY, OR IS IT THIS LARGER $38 BILLION GAP? SO I THINK IT'S INSTRUCTIVE TO BREAK IT DOWN A LITTLE BIT. WHEN YOU HEAR THAT THE HOUSE AND SENATE BILL -- THESE ARE THE ONES THAT EXPIRE ON DECEMBER 11TH, THE ONES THAT HAVE BEEN PUT FORWARD FOR NEXT YEAR, THE HOUSE BILL PROVIDES JUST A LITTLE BIT MORE THAN THE PRESIDENT'S BUDGET AT THE $1.1 BILLION INCREASE, THE SENATE BILL -- FOR NIH. THE SIGNAL BY PROVIDES A 2 BILLIONED INCREASE. BUT IF YOU LOOK AT WHERE IT'S STARRED HERE, YOU CAN SEE THAT FROM '15 TO '16, OVER ALL, THE BILLS ARE CUT. THEY'RE CUT BY ABOUT 3 1/2 BILLION DOLLARS. 3.6, $3.7 BILLION. SO IF YOU'RE CUTTING THE TOTAL AND INCREASING A PIECE WITHIN THE TOTAL, EVERYBODY HERE KNOWS MATH, THE INCREASES FOR NIH, IN PART, ARE FINANCED WITH CUTS THAT BOTH SIDES ARE GOING TO HAVE TO AGREE ON. SO THAT'S WHY WE HAVE A LITTLE BIT OF UNCERTAINTY IN WHETHER OR NOT THAT FUNDING IS GOING TO BE THERE. BOTH BILLS INCLUDE OVER A BILLION DOLLAR CUT TO THE AFFORDABLE CARE ACT. I DON'T KNOW, THE PRESIDENT DOES HAVE TO SIGN THE BILL IN THE END, SO THAT'S THE CHALLENGE. AND I'LL STOP THERE. NOW THAT EVERYONE IS JEALOUS OF MY JOB. [APPLAUSE] >> WE'RE A LITTLE OVER TIME BUT WE DO HAVE TIME FOR ONE QUESTION. >> SORRY! >> THAT'S OKAY. ONE QUESTION FOR ADRIENNE. THAT WAS A PRETTY COMPREHENSIVE LOOK. DR. REGENSTEINER. >> I'M VERY CURIOUS ABOUT THE BILL SPONSORED BY REPRESENTATIVE UPTON IN COLORADO. IT SEEMS LIKE EVERYONE WANTS IT, BUT BECAUSE OF ALL THESE BARRIER, WHAT DO YOU THINK IS GOING TO HAPPEN TO THAT BILL IN THE SENATE? >> I THINK THAT THE MOMENTUM BEHIND THE BILL IS REALLY THE FUNDING FOR NIH. I THINK THERE'S A BIG CRY FOR MANDATORY FUNDING FOR NIH. IN THE HOUSE, THERE'S SOME PUSHBACK ON THE FDA PROVISIONS, I'M NOT AN EXPERT IN FDA POLICY SO I CAN'T REALLY SPEAK TO THAT. IN THE SENATE, SENATOR MURRAY HAS SAID VERY CLEARLY THAT THE COST OF GETTING A BIPARTISAN BILL IS GETTING MONEY FOR NIH. SHE'S A GREAT CHAMPION FOR US. I THINK THE QUESTION IS, CAN THEY COME UP WITH AN AGREEMENT ON OFFSET. IF THEY CAN COME UP WITH AN AGREEMENT ON OFFSETS, THEN I THINK WE HAVE A GOOD CHANCE OF GETTING IT. IF THERE'S MO MONEY IN THE END AND THE LEADERSHIP ISN'T SUPPORTING IT -- JOHN BOEHNER WAS A BIG SUPPORTER OF THE 21ST CENTURY BILL. LOSING HIM IS A BIG LOSS IN THIS PROCESS. >> MAYBE HE'S NOT LEAVING AS SOON AS YOU THOUGHT. >> RIGHT. I DON'T THINK HE'LL BE AROUND NEXT YEAR, WHEN WE PROBABLY NEED A SPEAKER TO BE SUPPORTIVE. SO IT'S A LITTLE BIT UP IN THE AIR RIGHT NOW BUT I WILL SAY, EVERYBODY WHO'S BEHIND IT IS PUSHING REALLY HARD, AND THEY ALL SEEM VERY COMMITTED, SO THAT'S HUGE. >> THANK YOU, ADRIENNE. WE APPRECIATE THE COMPREHENSIVE UPDATE, AND I'M GOING TO NOW BRING TO THE PODIUM CAPTAIN TERRY CORNELISON. SHE'S GOING TO GIVE US AN UPDATE ON PROGRAMS AND SHE'LL BE FOLLOWED BY DR. LEAH MILLER, FOR THE SAME. WE ARE A LITTLE OVER TIME SO WE'RE GOING TO GO THROUGH THAT QUICKLY. I DO WANT TO MAKE SURE YOU ALL HAVE TIME TO DISCUSS A COUPLE OF ISSUES. WE HAVE ONE MORE TIME SLOT FOR DISCUSSION ON THE AGENDA TOO IN THE AFTERNOON, BUT WE WANT TO TRY TO GET TO SOME OF THAT THIS MORNING. DR. CORNELISON. >> GOOD MORNING. I AM DR. TERRI CORNELISON, AND IT IS MY PLEASURE TO SPEAK WITH YOU THIS MORNING ON ORWH'S BIRCH PROGRAM, BUILDING INTERDISCIPLINARY CAREERS IN WOMEN'S HEALTH. THIS IS BASED ON A PARADIGM THAT VIEWS INTERDISCIPLINARY APPROACHES AS ESSENTIAL TO MOVING FORWARD THE SCIENCE ASSOCIATED WITH WOMEN'S HEALTH AND TO INCREASING UNDERSTANDING OF THE INFLUENCES AFFECTING GENDER ON HUMAN HEALTH AND DISEASE. ORWH DESIGNED, DEVELOPED AND IMPLEMENTED THE BIRCH K-12 PROGRAM IN 1999 TO INCREASE THE NUMBER OF WOMEN'S HEALTH RESEARCHERS WORKING IN A MENTORED INTERDISCIPLINARY ENVIRONMENT. BIRCH SPONSORS JUNIOR FACULTY MEMBERS WHO HAVE RECENTLY COMPLETED CLINICAL TRAINING OR POSTDOCTORAL FELLOWSHIP AND WHO ARE BEGINNING BASIC TRANSLATIONAL CLINICAL AND/OR HEALTH SCIENTIST RESEARCH RELATED TO WOMEN'S HEALTH. THE PROGRAM PAIRS JUNIOR RESEARCHERS WITH SENIOR INVESTIGATORS. BIRCH IS BUILT UPON THREE PILLARS. STRONG MENTORING, INTERDISCIPLINARY RESEARCH, AND CAREER DEVELOPMENT. THE PROGRAMS ACCOMPLISH THESE GOALS BY ENSURING THAT MENTORS REPRESENT DIVERSE, DISCIPLINES NEEDED TO CARRY OUT INTERDISCIPLINARY PROJECTS THAT WILL BRIDGE TRAINING WITH RESEARCH INDEPENDENT FOR BIRCH SCHOLARS. AS OF OCTOBER 2015, ORWH HAS MADE 87 BIRCH AWARDS TO 43 ACADEMIC INSTITUTIONS. THERE ARE CURRENTLY 24 PROGRAMS ACTIVE. THIS MEANS THAT ORWH HAS HELPED TO TRAIN 476 SCHOLARS, 80% ARE WOMEN, 20% ARE MEN, AND THESE SCHOLARS ARE PHENOMENALLY SUCCESSFUL, AND I WILL GET TO THAT ON A SUBSEQUENT SLIDE. THE TOTAL INVESTMENT SINCE 2000, WHEN THE FIRST AWARDS WERE MADE, HAS BEEN $124 MILLION. INCLUDING NEARLY 6 MILLION FOR FISCAL YEAR '15. THERE IS A RECENT FDA VET, WENT OUT IN THE BIRCWH PROGRAM, THERE WERE 25 APPLICATIONS. THIS IS HIGHLY COMPETITIVE. 10 AWARDS WERE MADE. OVER THE PAST DECADE, THE ORWH HAS JOINED ITS FUNDING SUPPORTS BY MANY WHO ALSO WANT TO SEE THIS PROGRAM SUCCESSFUL. THE AGENCY FOR HEALTHCARE RESEARCH EQUALITY AND MANY OF NIH ICs HAVE JOINED IN THIS. THE NATIONAL CANCER INSTITUTE, NATIONAL INSTITUTE ON AGING, NATIONAL INSTITUTE ON AGING AND INFECTIOUS DISEASE, NATIONAL INSTITUTION ON ARTHRITIS, MUSCULOSKELETAL DISEASE, NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT, DENTAL, CRANIOFACIAL DISEASE, DRUG ABUSE, MENTAL HEALTH, AND NEUROLOGICAL DISORDERS AND STROKE, AND THE OFFICE OF DIETARY SUPPLEMENTS. THIS IS A JOINT EFFORT. WHILE ORWH IS RESPONSIBLE FOR THE PROGRAMMATIC ASPECTS OF THIS PROGRAM, OUR GRANTS AN MANAGEMENT ASPECTS RESIDE WITH THE EUNICE SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND DEVELOPMENT. MORE SCHOLARS HAVE PH.D.s THAN MDs, A SMALL PORTION HAVE BOTH BOTH. -- WILL HAVE A MASTER'S DEGREE. THE BIRCWH SCHOLARS COME FROM A WIDE RANGE OF FIELDS. MOST SCHOLARS HAVE DEGREES IN BIOLOGICAL, BIOMEDICAL SCIENCES, HEALTH SCIENCES, PHYSIOLOGY, PSYCHOLOGY, AND MEDICINE. ALMOST 50% OF COMPLETED BIRCWH SCHOLARS ACHIEVE A FACULTY RANK OF ASSOCIATES ARE FULL PROFESSORS. 56% HAVE HELD LEADERSHIP POSITIONS RANGING FROM FELLOWSHIP DIRECTOR TO DEAN. CURRENTLY OVER 82% HOLD ACADEMIC POSITIONS AND ALMOST 3% HAVE TAKEN RESEARCH POSITIONS OUTSIDE OF ACADEMIA. 78% OF BIRCWH SCHOLARS SUBMITTED AT LEAST ONE NIH GRANT APPLICATION 12 OR MORE MONTHS AFTER THEIR BIRCWH START DATE. OF THOSE WHO SUBMITTED APPLICATIONS, 64% OF SCHOLARS WERE RECEIVING AT LEAST ONE GRANT. THE RESPONSE RATE IS 64%. THE FIRST TWO COLUMNS LOOK AT ALL THESE GRANTS COMBINED. THE SECOND AND THIRD AND FOURTH COLUMNS ARE YOUR EARLY CAREER AND INDIVIDUAL K GRANTS, RESEARCH GRANTS, AND THEN THOSE RESEARCH GRANTS ARE FURTHER BROKEN OUT INTO RO1 GRANTS. IF YOU LOOK AT RESEARCH GRANTS, 69% OF BIRCWH SCHOLARS SUBMITTED AN APPLICATION AND THE FUNDING SUCCESS RATE WAS 51% AND HERE IS THE HALLMARK. THIS COMPARED TO THE TRANS-NIH FUNDING RATE OF THE LOW TEENS. WOMEN COMPARED TO MEN HAVE HIGHER APPLICATION-BASED SUCCESS RATES WHEN ALL GRANTS WERE GROUPED TOGETHER. HOWEVER, WHEN THE GROUPS WERE SEPARATED, THERE WAS NO STATISTICALLY SIGNIFICANT DIFFERENCES BETWEEN MEN AND WOMEN FOR RESEARCH GRANTS, AND THAT INCLUDES RO1s. BUT WHAT DOES THE SUCCESS REALLY LOOK LIKE? WHAT DOES THE STORE' REALL STORY REALLY LO OK LIKE? HERE IS ONE STORY. DR. ELIZABETH MILLER, WHO CAME INTO THE BIRCWH PROGRAM HIGHLY ACHIEVED AND WENT ON TO CONTINUE TO ACHIEVE WITH NUMEROUS POSITIONS, AWARDS AND HONORS, AND THIS VERY BUSY SLIDE IS MEANT TO SHOW THAT SHE HAS BEEN PRODUCTIVE AND VERY SUCCESSFUL IN GAINING FUNDING. THIS IS JUST ONE SUCCESS STORY. THERE ARE MANY SUCCESS STORIES IN THIS PROGRAM. THE ACKNOWLEDGMENTS, I'D LIKE TO THANK DR. ELIZABETH -- CURRENT PROGRAM OFFICER, DR. JENNIFER WHO DID THE DATA ANALYSIS FOR THIS, ALSO OUR FORMER BIRCWH PROGRAM OFFICERS AND ALSO THE LEADER OF OUR GRANTS MANAGEMENT TEAM AT THE NATIONAL INSTITUTE OF HEALTH AND DEVELOPMENT. I WOULD LIKE TO SAY THAT THE BIRCWH PROGRAM IS CURRENTLY UNDERGOING AN EVALUATION PROCESS AND WE WANT TO THANK THE INVESTIGATORS AND THE SCHOLARS AND THE SCIENTIFIC DIRECTORS IN THE BIRCWH PROGRAMS FOR THEIR INPUT INTO THIS BECAUSE THESE DATA WILL INFORM FURTHER DEVELOPMENT OF THIS VERY SUCCESSFUL PROGRAM. THANK YOU VERY MUCH. [APPLAUSE] >> THANK YOU, DR. CORNELISON. DR. MILLER? >> CAN I ASK A QUESTION ABOUT THIS PROGRAM? OR ARE WE GOING TO WAIT UNTIL THE END? >> IF WE COULD GET DR. MILL OTHER DO HER PRESENTATION, THEN WE'LL TAKE A COUPLE QUESTIONS. THANK YOU, VALERIE, APPRECIATE IT. >> ALL RIGHTY, THANK YOU. GOOD MORNING. MY NAME AGAIN ISLY A MILLER. IS LEAH MILLER. I WILL BE PRESENTING ON THE SCOR PROGRAM. SO ORWH DEVELOPED THE PROGRAM IN 2002 ON THE EFFECTS OF SEX AND GENDER FACTORS ON WOMEN'S HEALTH, DRAWING ATTENTION TO THE VALUE OF THIS APPROACH TO ACTUALIZING PERSONALIZED MEDICINE IMPROVING THE HEALTH OF BOTH MEN AND WOMEN. THIS HAS BEEN A COLLABORATION BETWEEN THE OFFICE OF RESEARCH ON WOMEN'S HEALTH AND SIX OF THE ICs HERE AT NIH, AS WELL AS THE OFFICE OF WOMEN'S HEALTH AT THE FOOD AND DRUG ADMINISTRATION. OVER THE LAST FEW YEARS, THE SCOR PROGRAM SITES HAVE BRIDGED BASIC AND CLINICAL RESEARCH. EACH PROGRAM SITE HAS AT LEAST THREE INTEGRATED SYNERGISTIC RESEARCH PROJECTS THAT EXPLORE A BREADTH OF RESEARCH TOPICS. AS YOU SEE HIGHLIGHTED BELOW. THESE INCLUDE RESEARCH IN THE AREAS OF ADDICTION, AS WELL AS SMOKING, URINARY TRACT INFECTIONS, AS WELL AS PELVIC FLOOR DYSFUNCTION AMONGST OTHERS SHOWN. THE INVESTMENT IN THE SCOR PROGRAM HAS BEEN APPROXIMATELY $132 MILLION FROM FY 2002 TO PRESENT FY15. THE SCOR PROGRAM IS A P50 MECHANISM IN WHICH WE HAVE 5-YEAR AWARDS. THEREFORE, WE HAVE HAD THREE ITERATIONS OF THE SCOR PROGRAM. THE FIRST BEING FROM 2002 TO 2007, THE SECOND 2007 TO 2011, AND OUR THIRD REITERATION OF THE PROGRAM AT PRESENT, 2011 TO 2015. AND FOR EACH OF THE REITERATIONS, WE'VE HAD 11 PROGRAM SITES. OVER THE PAST FEW YEARS, WE HAVE EVALUATED THE SCORE PUBLICATIONS BY THE NUMBER OF CITATIONS, AND SO WHAT YOU'RE SEEING HERE IS THE TOP 12 SCORE PUBLICATIONS FROM 2002 TO SEPTEMBER OF THIS YEAR. AND YOU'LL SEE, AGAIN, THERE'S BEEN A VARIETY OF RESEARCH EFFORTS AND AS NOTED, SOME OF THE TOP PUBLICATIONS INCLUDE BACTERIAL COMMUNITY VARIATION IN THE HUMAN BODY WITH 765 CITATIONS, ANTERIOR VERSUS TRANSVAGINAL MESH, 270 CITATIONS, AND THE NUMBER OF CITATIONS HAVE BEEN GREAT FOR THE OTHER REMAINING PBLCATIONS AS WELL. WE'D ALSO LIKE TO NOTE THAT THESE PUBLICATIONS ARE PUBLISHED IN HIGH IMPACT JOURNALS, WHICH REALLY SPEAKS TO THE IMPORTANCE OF THEIR RESEARCH BUT ALSO THE OUTSTANDING RESEARCH PERFORMED BY OUR INVESTIGATORS. WE ARE VERY, VERY PLEASED, AND I WOULD ALSO LIKE TO NOTE THAT OUTSIDE OF THE PUBLICATIONS, THE PROGRAM INVESTIGATORS AND DIRECTORS AT THE SITE ARE REALLY MOVING FORWARD IN SHARING THIS APPROACH OF SEX AND GENDER RESEARCH AT THEIR INSTITUTIONS. AND THAT'S BEING ADOPTED ACROSS THE BOARD AT SEVERAL INSTITUTIONS. SO PHYSICALLY, I HAD THE OPPORTUNITY TO SEE FIRSTHAND SOME OF THE EFFORTS GOING ON BY DR. EFFERSON AND HER GROUP AT THE UNIVERSITY OF PENNSYLVANIA. RECENTLY, AT THE BEGINNING OF THIS MONTH, OCTOBER 2ND, WE PUT OUT A GUIDE NOTICE TO INFORM THE PUBLIC THAT WE WOULD BE EVALUATING THE SCOR PROGRAM. WE HAVE CONTRACTED -- EVALUATION IS A STANDARD PRACTICE HERE AT NIH, AND WE ARE LOOKING FORWARD TO THE RESULTS THAT WILL BE YIELDED FROM THIS EVALUATION, AND WE WILL UTILIZE IT IN INTERNAL DECISION-MAKING. WITH THAT, I WELCOME ANY QUESTIONS AND WOULD LIKE TO THANK YOU FOR YOUR TIME. [APPLAUSE] >> SO WHY DON'T WE HAVE BOTH DR. CORNELISON AND DR. MILLER UP AT THE FRONT. FIRST VALERIE, THEN DR. GREEN. >> FIRST OF ALL, THANK YOU ALL, TWO GREAT PRESENTATIONS, AND TWO, I THINK, FUNDING MECHANISMS THAT ARE OF VALUE, AND I LOVE THE FACT THAT WE CAN DOCUMENT -- WHEN WE CAN DOCUMENT OUTCOMES AND I DO LIKE YOUR METRICS THAT YOU'RE LOOKING AT. MY FIRST QUESTION IS FOR -- IS IT COLONEL? >> CAPTAIN. >> CHIEF, OKAY, HOW ABOUT THAT? WERE THERE ANY DIFFERENCES BETWEEN THE SUCCESS RATE OF GRANTS SUBMITTED AND FUNDED BETWEEN THE MD SCIENTISTS AND THE PH.D. SCIENTISTS? AND THE REASON I ASK THIS QUESTION IS THAT MANY OF YOU ALL UNDERSTAND THE CHALLENGES WE HAVE WITH COMMISSIONED SCIENTISTS, SO HAVE WE LOOKED AT THAT, AND THEN BEYOND THE GENDER DIVERSITY, HAVE WE LOOKED AT THE RAISHT AND ETHNIC DIVERSITY OF THOSE PERSONS WHICH WE HAVE AWARDED GRANTS TO FOR BIRCWH AND THE P.I. STATUS AND FOR THE SCOR, AND THEN FOLLOWING THAT, EVEN IF THOSE PERSONS WERE NOT -- HAVE WE LOOKED AT THE DIVERSITY OF THE PERSONS WHO ARE ON THESE GRANTS WHO ARE GETTING PILOT AWARDS? BECAUSE SOMETIMES THAT'S VIEWED AS A MECHANISM FOR THE PIPELINE. >> WHAT WE HAVE ACTUALLY TAKEN A LOOK AT, WHAT WE FOUND IS THAT THERE'S NOT SO MUCH SUCCESS RATE BETWEEN MDs AND PH.D.s, BUT WE FIND THAT THE PH.D.s HAVE APPLIED MORE FOR GRANTS THAN MDs. >> BUT WHAT WAS THE -- THE PERCENTAGE RATE FUNDED? >> BUT THE SUCCESS RATE IS COMPARABLE. >> OH, SO THE SUCCESS RATES WERE COMPARABLE BUT THE PH.D.s APPLY MORE? >> YES. >> OKAY. AND THEN THE BREAKDOWN OF RACIALLY AND ETHICALLY ON THE PIs OF THE GRANT? >> THAT INFORMATION, I DO NOT HAVE. WE LOOKED AT IT BY MALE AND FEMALE, SO WE CAN LOOK IN TO SEE WHERE THAT INFORMATION IS. WE FIND THAT -- I DON'T HAVE MY INFORMATION IN FRONT OF ME RIGHT NOW, BUT WE CAN CERTAINLY CALL FOR THAT. >> OKAY. HI, JEW NAN WE'RE ACTUALLY DOING AN EVALUATION OF BIRCWH RIGHT NOW AND THAT IS ONE OF THE QUESTIONS WE HAVE. WE'RE DOING A MIXED METHODS APPROACH IN OUR EVALUATION, BOTH QUANTITATIVE AND QUANTITATIVE DATA. WE'VE DONE SURVEYS ACTUALLY OF THE SCHOLARS THEMSELVES, THE P.I.s, THE MENTOR, AND WE'LL ALSOING FOLLOWING UP WITH DATA THAT WE HAVE HERE AT NIH THAT WE'VE COLLECTED IN OUR SYSTEM THAT LOOKS AT PEOPLE'S PUBLICATIONS, AWARDS, THAT KIND OF THING. SO WE WILL HAVE A REPORT ON THAT AND EVALUATION AND WE CAN CERTAINLY SHARE THE RESULTS OF THAT AT THE NEXT MEETING, IT'S JUST THAT RIGHT NOW, IT'S NOT COMPLETE. SO IT'S DIFFICULT FOR TERRI TO SPEAK TO ALL THAT, BUT WE ARE LOOKING AT THAT AS SOMETHING WE'RE INTERESTED IN. >> WILL YOU MAKE SURE, I KNOW SOME OF THE AWARDS, THERE'S PILOT STUDIES AND OTHER PERSONS, JUNIOR PEOPLE WHO ARE ON THE AWARDS WHO GET TO DO PILOTS GRANTS. WILL YOU ALSO LOOK AT THE TRABBING OTRACKING OF THOSE INDIVIDUALS, BECAUSE THOSE ARE THE PEOPLE THAT YOU PIPELINE FOR YOUR K AWARDS AND THAT TYPE OF THING. >> WE'RE DOING OUR BEST TO FIND EVERYONE. US A KNOW, THAT'S A CHALLENGE TO KEEP TRACK OF TRAINEE, WHERE THEY GO, BECAUSE ONCE THEY EXIT THE PROGRAM, THEY DON'T OWE US ANYTHING, BUT WE'RE DOING OUR BEST WITH THE AGE OF GOO DPEL, SO STAY TUNED. >> DR. GREEN AND THEN DR. WEISS, AND THEN I THINK WE'RE GOING TO HAVE TO -- >> MY QUESTION WAS REALLY FOCUSED ON THE RACE AND ETHNICITY DIFFERENCES IN REGARDS TO THE REPORT, BUT I ALSO -- I JUST HAVE A COMMENT AS TO WHY IN THESE PARTICULAR PROPOSALS HAVE WE ONLY SORT OF TARGETED TO THE JUNIOR INVESTIGATOR? IT WOULD SEEM THIS WOULD BE AN OPPORTUNITY AS YOU START THINKING ABOUT -- >> THE CO CONFIGURATION OF THE BIRCWH, THE ENTIRE CADRE OF PEOPLE DOING WOMEN'S HEALTH, WOMEN'S HEALTH RESEARCHERS. TO CLEARLY THAT TRANSITION POINT TO INDEPENDENCE IS REALLY ONE OF THE KEY TRANSITION POINTS AND WAS IDENTIFIED IN THE PAST AS AN AREA FOR INTERVENTION, BUT DO I HEAR YOU SAYING YOU'RE CONCERNED ABOUT FURTHER DOWN IN THE PIPELINE AS WELL? >> YEAH T IT SEEMED TO ME THAT THERE'S AN OPPORTUNITY TO -- PARTICULARLY US A THINK ABOUT MD SCIENTISTS WHO YOU MAY COME THROUGH LATER. OFTEN WE PUT THIS ARBITRARY TIME FRAME IN WHICH WE SAY 10 YEARS FOR YOUR TERMINAL DEGREE, WELL, 10 YEARS FROM MY TERMINAL DEGREE, I'M NOT CERTAIN WHAT I WAS DOING BUT IT PROBABLY COULD STILL BE -- FIVE YEARS OF THAT WAS STILL WITHIN THE TRAINING. SO THAT MAY BE AN OPPORTUNITY TO EXPAND WOMEN'S RESEARCH TO GET PEOPLE WHO ARE NEWER -- WHO COULD BE NEW TO IT BUT MAY BE OLDER. >> NEW TO FIELD, ABSOLUTELY. THE WHOLE ISSUE OF PHYSICIAN SCIENTISTS IS REALLY BEING CONSIDERED CAREFULLY BY NIH RIGHT NOW, THERE'S AN ACD WORKING GROUP, DR. COLLINS HAD A WORKING GROUP ON THAT TOPIC, AND SO THOSE ISSUES ARE DIFFERENT AS YOU VERY WELL KNOW FOR CLINICIANS AND THE TIMING IS DIFFERENT, SO THANKS FOR BRINGING IT UP AND WE'LL THINK ABOUT THAT. >> ALSO IN THE BIRCWH ELIGIBILITY THAT THAT TIME FRAME OF ELIGIBILITY, FIRST YEAR TIME IN RESEARCH -- STEPPED AWAY OUT OF THE RESEARCH REALM THAT THAT CHANGES THE TIMELINE. THAT CHANGES YOUR TIMELINE. >> SO DR. WEISS AND THEN DR. MASU RI. >> I MENTIONED THIS BEFORE AT THE LAST MEETING. THE ISSUE OF THE BIRCWH AS ONE EXAMPLE I THINK HAS WEAKNESSES THAT WILL DECREASE THE RATE OF INDIVIDUALS WHO ARE MINORITIES OR IMPROVE RISHED AND WHO ARE WOMEN. ONE ISSUE IS THERE ARE ONLY 24 PLACES YOU CAN HAVE A BIRCWH. THERE ARE HUNDREDS OF MEDICAL SCHOOLS OR SIMILAR PLACES TO TRAIN, ALL OF WHOM HAVE GOOD SCIENCE. VARIABLE, BUT THERE ARE GOOD PEOPLE EVERYWHERE. YOU HAVE TO GO TO A BIRCWH CENTER. IF YOU ARE UNDERPRIVILEGED, YOU'VE SPENT SOME -- AND YOU'VE GONE THROUGH A RESIDENCY OR A FELLOWSHIP AFTER YOU'VE GONE THROUGH RESIDENCY AFTER COLLEGE AND MEDICAL SCHOOL, YOU'RE IN YOUR I MID TO EARLY 30s. IF YOU DID TAKE TIME OUT. YOU DIDN'T, YOU'RE EVEN OLDER. YOU HAVE PROBABLY PICKED UP A LITTLE BIT OF BAGGAGE. YOU'VE GOT POSSIBLY A SPOUSE, POSSIBLY CHILDREN, IF YOU HAVE ANY OF THESE THINGS, YOU'VE GOT A SYSTEM TO TAKE CARE OF THEM. YOU'VE GOT YOUR PARENTS WITH YOU. YOU'VE GOT A SPOUSE THAT IS VERY UNDERSTANDING AND VERY HELPFUL. YOU'VE GOT A COMMUNITY THAT HELPS YOU. YOU CAN'T BE PICKING UP FROM WHERE YOU ARE AT THAT POINT, AND GO TO ANOTHER TOWN AND MOVE THAT WHOLE SYSTEM WITH YOU. IT JUST WILL NOT WORK. SO THAT'S A MAJOR DISADVANTAGE. OTHER DISADVANTAGES ARE THINGS LIKE A SALARY. THESE ARE INDIVIDUALS WHO ARE AT A TIME IN THEIR LIVES WHEN THEY NEED TO BE EARNING A LIVING THAT HAVE BEEN PARTIALLY PAID, THERE'S A HOUSE OFFICER, OR NOT PAID AT ALL AS A STUDENT, AND NOW DAYS, I THINK THAT WOULD BE A SUM OF MONEY THAT WOULD START AT 100,000 AND MANY PROGRAMS THAT DO THIS GO UP TO ABOUT 130. SO I DON'T KNOW WHAT THE FUNDING IS AT BIRCWH, BUT I'M PRETTY WELL FIGURING IT'S MUCH LESS THAN THAT. IS THAT THE CASE? HOW MUCH? 125 NOW? OKAY. >> WE ACTUALLY PAY 75% OF THE SALARY. BUT THE INSTITUTION OFTEN MAKES UP THIS DIFFERENCE. SOME OF THE THINGS YOU'RE SAYING DON'T NECESSARILY -- ARE NOT NECESSARILY CORRECT ACROSS THE BIRCWH SYSTEM. IT'S BETTER, SURELY, TO HAVE SOME TRAINING PROGRAM THAN NOT, AND PEOPLE WOULD BE GOING THROUGH FELLOWSHIP EITHER IN BIRCWH OR IN ANOTHER PROGRAM AT THIS STAGE IN THEIR LIVES, SO I DON'T UNDERSTAND EXACTLY WHAT YOU'RE SAYING. >> MOST PEOPLE GO INTO A PROGRAM AFTER THIS IN THE FELLOWSHIPS, WHICH ARE PRETTY MUCH CLINICAL. SO IT WOULD BE, IN MANY FIELDS, COLLEGE, MEDICAL SCHOOL, OR RESIDENCY, OB-GYN, WHICH IS MY FIELD, FOUR YEARS, THEN A FELLOWSHIP AND A SUBSPECIALTY WHICH IS THREE YEARS, AND USUALLY THEY'VE ALREADY HAD EXPERIENCE DOING SOME RESEARCH AND THAT'S WHAT GOT THEM INTO IT DURING THE FELLOWSHIP IN THEIR LAST INSTITUTION. SO THE LIKELIHOOD IS THEY'RE GOING TO WANT TO STAY THERE. AND THEY'RE SET UP TO STAY THERE. THIS WOULD PRECLUDE IT. SPECIFICALLY IF WE'RE LOOKING FOR PEOPLE WHO ARE UNDERPRIVILEGED, THEY DON'T HAVE A LOT OF MONEY AND THEY DON'T HAVE AN ABILITY TO MOVE UP AND HIRE STAFF AND HAVE HOUSEKEEPERS AND SOMEONE TO WATCH THE KIDS. SO IT'S A BIG DEAL SO HAVE THEM MOVE, AND THAT'S REALLY A DISADVANTAGE. >> THANKS FOR THE FEEDBACK, DR. WEISS. AS YOU KNOW, BIOMEDICAL WORKFORCE IS UNDERGOING A LOT OF STRESS AND STRAIN ACROSS THE BOARD, AND THE BIRCWH AS A K12 IS ONE ACTIVITY CODE THAT IS AVAILABLE, THERE ARE INDIVIDUAL Ks THAT ARE ALSO -- SOME OF THOSE FOLKS WOULD BE ELIGIBLE FOR. SO -- AND I ALSO WANT TO DRAW YOUR ATTENTION TO THE ORIGINAL PURPOSE OF THE BIRCWH AGAIN TO EXPAND THE CADRE OF WOMEN'S HEALTH RESEARCHERS. AS I MENTIONED, SINCE WE ARE EVALUATING THE PROGRAM, THIS IS A GREAT TIME TO GET THIS INPUT FROM EVERYONE AND TO HEAR FROM YOU, AND WE'LL CERTAINLY TAKE THAT INTO CONSIDERATION. CAROLYN, I'M GOING OH GIVE YOU THE LAST WORD BECAUSE WE ARE OVER TIME AND I WANTED TO AT LEAST START THE CONVERSATION ON YOUR EARLIER QUESTION BEFORE LUNCH SO MEEM COULD BE THINKING ABOUT THAT OVER LUNCH. SO IF YOU COULD DO YOUR COMMENT AND THEN REMIND US OF YOUR QUESTION? >> THANK YOU. SO MY QUN ONE QUESTION IS IN REGARD TO THE SCOR, AND MY UNDERSTANDING IS AS A FUNCTION OF THE EVALUATION OF THE SCO, THE RFA IS NOT GOING TO BE RELAYS LEASTERELEASED FOR SOME PERIOD OF T IME SO CURRENT SCORS WOULD POTENTIALLY BE ELIGIBLE FOR BRIDGE FUNDING, IS THAT CORRECT CORRECT? >> THAT WILL BE DETERMINED ON A CASE-BY-CASE BASIS. >> SO I THINK IT WOULD BE HELPFUL FOR EXISTING SCORES TO KNOW ABOUT THAT SOONER THAN LATER, AND THAT PROCESS, BECAUSE ONE OF THE THINGS I THINK THAT WE'VE ALL THOUGHT IS REALLY IMPORTANT IN THE WORK THAT THIS OFFICE DOES IS ENSURE THAT THERE'S DON'T FEUNT, AN CONTINUITY AND THA T THE CENTERS THAT ARE BUILT DON'T GO AWAY AS A FUNCTION OF SOME ADMINISTRATIVE IMPORTANCE BUT ADMINISTRATIVE ACTION, SO THAT WOULD BE REALLY HELPFUL IF YOU COULD LET US ALL KNOW THAT. SO THE EARLIER QUESTION THAT GARRETT AND OTHERS BROUGHT UP REALLY HAD TO DO WITH THE ISSUE OF POWER AS IT RELATES TO STUDYING MALES AND FEMALES, AND WHETHER OR NOT THE OFFICE COULD CLARIFY A BIT MORE THE DISTINCTION BETWEEN STUDYING MALES AND FEMALES AND HAVING ADEQUATE POWER TO DETERMINE WHETHER OR NOT THERE ARE SEX DIFFERENCES. >> SO THE QUESTION THAT DAVID, I KNOW YOU WANTED TO CHIME IN ON IT, SO IF YOUR PRIMARY RESEARCH QUESTION IS NOT IS THERE A SEX DIFFERENCE BETWEEN PATHWAY Q, THEN YOU'RE POWERED FOR WHATEVER YOUR PRIMARY RESEARCH QUESTION IS, YOU'RE NOT POWERED TO DETECT SEX DIFFERENCES. SO I THINK YOU ALSO SAID, WELL, IF YOU'RE NOT POWERED TO DETECT SEX DIFFERENCES AND WE ARE ENCOURAGING SEX-SPECIFIC RESULTS REPORTING, HOW MIGHT THAT BE PERCEIVED? DO I GET THAT CORRECT? OKAY. SO THAT IS CERTAINLY A VALID QUESTION, AND THAT'S TYPICALLY WHAT WE'VE BEEN HEARING THERE. SO REPORTING SEX-SPECIFIC RESULTS IN THE CONTEXT OF A STUDY THAT IS NOT POWERED TO DETECT SEX DIFFERENCES HAS TO BE ACCOMPANIED BY THAT CAVEAT THAT THIS WAS NOT POWERED TO DETECT SEX DIFFERENCES, THESE ARE THE FINDINGS IN MALES AND FEMALES, YOU MAY COMBINED IMIEN THE COMBINE THEM FO R YOUR ANALYSIS, SO WE ARE NOT ENCOURAGING PEOPLE TO OVERSTATE AND WE ARE CONCERNED THAT PEOPLE CAN OVERINTERPRET OR MISINTERPRET, RATHER, SAYING THERE IS A SEX DIFFERENCE WHEN YOU WEREN'T EMPOWER TODAY DETECT ONE, BUT WE HAVE TO GET MORE SEX-SPECIFIC DATA OUT THERE SO THAT OTHER PEOPLE COULD ACTUALLY DO A SAMPLE SIZE CALCULATION AND POWER IS IT YOU DI TO DETECT SEX DIFFERENCES WHERE WE HAVE A SITUATION IN PRE-CLINICAL RESEARCH NOW WHERE THERE'S THE POSSIBILITY OF SEX-SPECIFIC DATA. SO WE'RE STUCK, WE'RE IN A LOOP HERE. SO ADMITTING TRANSPARENTLY THE LIMITATIONS OF A STUDY DESIGN, NOT OVERGENERALIZING THE FINDINGS OF A STUDY ARE KRIT TALL TO THIS PIECE, AND SO THAT'S WHERE WE REALLY WANTED TO PUT FORWARD. NOW, IF YOU KNOW THERE'S A SEX DIFFERENCE IN WHAT YOU'RE STUDYING, THEN IT'S VERY LIKELY, IT DEPENDING ON WHERE YOU ARE IN THE CONTINUUM OF BASIC, BASIC TO PRE-CLINICAL, THAT YOU SHOULD BE ACCOUNTING FOR THAT IN YOUR STUDY DESIGN, IF YOU KNOW THAT. >> DAVID, DO YOU WANT TO MAKE A COMMENT, AND THEN WEI JEN? >> JUST TO FOLLOW UP ON THAT POINT, AND FIRST, JANINE, IN YOUR OPENING COMMENTS YOU SPOKE ABOUT ENGAGING IN POLICY CHANGE AT NIH AS A TEAM SPORT, I THINK YOU ACTUALLY MEANT TO SAY IT'S A CONTACT SPORT. >> I DIDN'T SAY IT WAS A CONTACT SPORT BUT IT IS A CONTACT SPORT. >> THAT'S WHAT I WAS HEARING. SO I THINK, YOU KNOW, YOU'RE TO BE APPLAUDED FOR THE CARE WITH WHICH YOU ARE WORKING TO GET NOT JUST THE SUBSTANCE BUT ALSO THE MESSAGING RIGHT. AND TO MOTIVATE THE TEAM. SO JUST TO PICK UP ON SOME OF THE THINGS THAT CAROLYN AND OTHERS HAVE SPOKEN TO, SO SOME OF THE DISTINCTIONS THAT YOU'RE DRAWING SEEM VERY SUBTLE TO ME. LET ME JUST NAME IT. IN A WAY THAT I THINK COULD BE VERY -- COULD BE MISUNDERSTOOD. LET ME JUST SAY IT. SO WE'VE BEEN TALKING ABOUT SEX AS A BIOLOGICAL VARIABLE. IT'S ONE OF THE CATCH PHRASES. IN THIS CONTEXT. AND THEN YOU WERE DRAWING THE DISTINCTION EARLIER THIS MORNING BETWEEN STUDYING BOTH SEXES, VERSUS STUDYING SEX DIFFERENCES. AND IN THE CONTEXT OF THE POWERING STUDIES. SO I WILL JUST GO ON THE RECORD AS SAYING I THINK THAT THE DIFFERENCE BETWEEN -- THE DISTINCTION BETWEEN STUDYING BOTH SEXES AND STUDIES SEX DIFFERENCE, I BELIEVE THAT THAT DISTINCTION WILL BE EXTREMELY DIFFICULT FOR PEOPLE OUTSIDE OF THIS ROOM TO UNDERSTAND, ESPECIALLY WHEN IT IS IN THE SAME PARAGRAPH WITH THE PHRASE "SEX AS A BIOLOGICAL VARIABLE." BECAUSE IT SEEMS TO ME WHAT WE'RE SAYING IS THAT IF I UNDERSTAND THE DISTINCTION, IT'S BETWEEN -- WHEN WE SAY WE'RE STUDYING BOTH SEXES BUT NOT STUDYING SEX DIFFERENCES, IN THAT CASE, YOU'RE EXPLICITLY TREATING SEX AS NOT A VARIABLE UNDER STUDY. OR YOU'RE NOT CLAIMING THAT YOUR STUDY WAS DESIGNED -- AND I UNDERSTAND -- I THINK I UNDERSTAND THE DISTINCTION BETWEEN THESE TWO, BUT WHAT I'M SAYING IS I THINK THE DISTINCTION IS TOO FINE A ONE TO ACTUALLY BE UNDERSTOOD VERY WIDELY OUTSIDE THE REALM OF SMALL GROUPS LIKE OURSELVES WHO ARE DEEPLY INVESTED IN THESE SORTS OF QUESTIONS. SO IT SEEMS TO ME IF WE'RE EE ESSENTIALLILY SAYING THAT WE'RE GOING TO FAVOR STUDIES THAT ARE NOT POWERED TO TREAT SEX AS A VARIABLE, THAT IT'S VERY DIFFICULT TO TALK ABOUT THAT IN THE SAME PARAGRAPH AS WHERE WE'RE PROCLAIMING THE IMPORTANCE OF SEX AS A BIOLOGICAL VARIABLE. >> SO LET ME JUST CLARIFY, THAT'S NOT WHAT I MEAN. THE TERMS SEX DIFFERENCES AND SEX DIFFERENCES RESEARCH IS A TERM THAT I THINK IS PROBLEMATIC RIGHT NOW BECAUSE OF THIS DISCUSSION, BECAUSE PEOPLE THINK THEY KNOW WHAT IT IS, AND PEOPLE MOSTLY DEFAULT TO THAT MEANING PEOPLE IN THE FIELD DEFAULT TO THAT MEANING THAT YOUR PRIMARY RESEARCH QUESTION, IS SEX DIFFERENT. OTHER PEOPLE DO NOT DEFAULT TO THAT. SO THAT'S ONE OF THE REASONS WHY OUR LANGUAGE ABOUT THIS HAS TO BE VERY CAREFUL AND SO THAT'S WHY I USE INFLUENCE, TO INFLUENCE SEX AS A BIOLOGICAL VARIABLE, AND DID NOT MEAN THAT THE VARIABLES SHOULD NOT BE INCLUDED, I WAS TRYING TO MAKE THE DISTINCTION THAT EVERY SINGLE EXPERIMENT MAY NOT BE POWERED TO DETECT SEX DIFFERENCES AND THAT SEX COULD BE STILL CONSIDERED AS A BIOLOGICAL VARIABLE AND FACTORED INTO IT, FOR EXAMPLE, USING A FACTORIAL DESIGN. SO YOU CAN STILL LOOK AT IT, IT'S STILL POWERED BY THAT. YOU'RE STILL LEARNING ABOUT BOTH SEXES, YOU'RE STILL STUDYING BOTH SEXES. THAT'S WHAT I WAS TRYING TO PUT FORWARD. WITH THAT EXPLANATION, IS THAT -- >> I'D SAY I COMPLETELY GET IT. I UNDERSTAND EXACTLY WHAT YOU'RE SAYING. BUT I THINK THAT IT ALMOST -- THE PROBLEM IS IT ALMOST TAKES A MINUTE TO EXPLAIN -- AT A MINIMUM, IT TAKES A MINUTE TO EXPLAIN THIS DIFFERENCE. WITH MOST OF OUR COLLEAGUES, WE DON'T HAVE A MINUTE. THERE'S NOT A MINUTE TO GO INTO THE SUBTLETIES OF ALL OF THIS. THEY'VE ALREADY FORMED A REACTION TO WHAT'S BEING REQUESTED. >> AS YOU SAID, IT'S A CONTACT SPORT, AND MY EXPERIENCE, I GET THE CONTACT FIRST, THEN I JUST WAIT FOR THE CONVERSATION, AND IF WE CAN HAVE A CONVERSATION AFTER THAT FOR AT LEAST A MINUTE, THEN THERE'S SOME THINKING THAT GOES ON AND THEN MAYBE 5 TO 10, 15 MINUTES OR 15 YEARS, I DON'T KNOW, IT DEPENDS ON THE PERSON, WE HAVE A DIFFERENT CONVERSATION, BUT YOU'RE RIGHT, IT TAKES 12 STEPS OF THOUGHT TO KIND OF -- WHAT ABOUT THIS? AND THAT'S ONE OF THE THINGS WE IT DID GET FEEDBACK ON THE RFI AND EVERYWHERE WE'VE GONE THAT EVERYONE IS ASKING FOR MORE MATERIAL AND SO THAT'S WHY WE HAVE -- MAKING SURE WE HAVE FAQs AND MORE MATERIAL AVAILABLE ON THE WEB TO HELP PEOPLE THINK THROUGH THESE ISSUES IN THE CONTEXT OF THEIR SCIENCE. NOW THAT BRINGS UP ANOTHER QUESTION IN THAT I HOPE MY ADVISORY MEMBERS CAN HELP ME WITH, AND THAT IS I'M AWARE OF A PUBLICATION THAT'S COMING SOON, IT'S ACTUALLY IN PRESS, I DON'T KNOW IF THE LINK IS AVAILABLE, BUT IT DESCRIBES VERY COMPREHENSIVELY ACCOUNTING FOR SEX AS A BIOLOGICAL VARIABLE IN ONE PARTICULAR CONTEXT. SO IT GOES IN DEPTH FOR A SPECIFIC FIELD, WHICH IS WHAT IS NEEDED, SO WE NEED MORE FIELDS TO ADDRESS THAT AND I WILL COMMEND ONE OF THE INSTITUTE DIRECTORS, GEORGE -- CHALLENGED HIS DIVISION DIRECTORS TO DEVELOP STANDARD PROTOCOLS FOR THOSE DIVISIONS PUBLICLY, AND FOR PEOPLE TO DIVE DEEP AND TO WORK ON THAT AND NOT RELY ON -- NIH IS GOING TO TELL US EXACTLY HOW TO DO THIS, BECAUSE WE'RE NOT, I DON'T THINK YOU WANT US TO, AND IT'S SO DEPENDENT ON THE CONTEXT OF THE DISCIPLINE, THE RESEARCH QUESTION OF THAT STUDY AND WHAT IS ALREADY KNOWN. IT IS COMPLICATED, WE HAVEN'T FOUND A WAY TO MAKE IT A ONE MINUTE CONVERSATION. WE HAVE WORKED VERY HARD ON THE MESSAGING, SO IF ANY OF YOU HAVE PHRASES OR THOUGHTS THAT YOU THINK CONVEY IT MORE CLEARLY, WE CERTAINLY WOULD BE OPEN TO THAT. IS THIS THE SAME POINT? >> SAME LINE OF DISCUSSION. I THINK THERE ARE SUBTLE DIFFERENCES BETWEEN THOSE TWO, BUT I THINK IT'S VERY IMPORTANT TO MAKE A DISTINCTION BETWEEN THOSE TWO. I THINK IF YOU WANT TO STUDY THE SEX DIFFERENCES, UNFORTUNATELY YOU HAVE TO INCREASE THE COST. SO IF YOU JUST SEPARATE THOSE REGIONALLY, YOU HAVE THIS EMPA SIZED INTO THE MALE AND FEMALE, WHAT YOU GET IS THE KNOWLEDGE IN TERMS OF SOME MALE DATA, SOME FEMALE DATA, BUT YOU REALLY COULDN'T MAKE A -- ANYTHING RELATED TO THE SEX DIFFERENCES, UNLESS YOU HAVE ENOUGH POWER ACTUALLY TO ASSESS THAT THERE IS A DIFFERENCE THERE. SO SO THE FACT IS IF YOU REALLY WANT TO STUDY THE SEX DIFFERENCE, I THINK YOU NEED TO INCREASE THE NUMBER AND YOU PROBABLY HAVE TO INCREASE THE COST, BUT WHETHER IT'S A DOUBLE, PROBABLY NOT, BECAUSE YOU CAN HAVE A DIFFERENT DESIGN OF THE STUDY AND MAKE IT MORE -- YOU CAN COMBINE THE MALE AND THE FEMALE INTO THEIR ONE ANALYSIS OF THEIR VAI VARIANCES. I THINK ALSO THE FIELD HERE, FROM A NON-TRADITIONAL SEX DIFFERENCES RESEARCHER, ALSO I THINK IT'S IMPORTANT TO INVEST IN MONEY TO IT UNDERSTAND IF THERE'S NO SEX DIFFERENCES, THAT RESULT, IT'S STILL A VERY VARIABLE RESULT. I THINK ONE OF THE PROBLEMS WE HAVE ENCOUNTERED RIGHT HERE IS THE REPRODUCIBILITY RIGHT HERE, AND THAT'S I THINK ONE OF THE CONTRIBUTORS TO THAT PROBLEM IS BECAUSE IT IS NOT ENOUGH -- NO EFFECT DATA HAS BEEN PUBLISHED. SO I THINK IT'S ALWAYS AN INVESTMENT, I DON'T THINK IT'S A COST -- YOU END UP HAVING NO SEX DIFFERENCES AND YOU SAY I WASTE ALL THE MONEY HERE, BUT I THINK THAT'S A VERY VALUABLE PIECE OF INFORMATION THAT NEEDS TO BE PUBLISHED AND THEN NOW THE QUESTION IS HOW ARE YOU GOING TO CONVINCE ALL THOSE JOURNALS TO PUBLISH THOSE DATA. SO I THINK THAT THERE'S A SUBTLE DIFFERENCE BETWEEN THOSE TWO BUT I THINK ALL THE RESEARCHERS NEED TO UNDERSTAND THAT. ALSO IN PARTICULAR I THINK THE STUDY SECTIONS ALSO NEED TO UNDERSTAND THAT TOO. >> THANKS FOR THAT COMMENT. I WANT TO MAKE SURE YOU'RE AWARE THAT NIH HAS BEEN WORKING WITH A VARIETY OF THE JOURNAL EDITORS TO TRY TO ENCOURAGE STANDARDIZED INSTRUCTIONS AND REQUIREMENTS ALL AROUND THIS REPRODUCIBILITY ISSUES AND REPORTING OF SEX AND PRE-CLINICAL AND ANIMAL RESEARCH IS ONE OF THE ITEMS THAT HAS BEEN ADOPTED BY MANY, MANY MORE JOURNALS TO THE POINT THAT IT MIGHT COST MORE TO DO A SEX DIFFERENCES STUDY, OF COURSE THAT WOULD DEPEND ON THE MAGNITUDE OF SEX DIFFERENCE AND OTHER FACTORS, BUT IF WE HAVE NO SEX-BASED DATA, THEN YOU'RE NEVER GOING TO BE ABLE TO PERFORM THE SEX DIFFERENCES STUDY AND SO WHAT WE'RE TALKING ABOUT IS BUILDING A KNOWLEDGE BASE AROUND MALE AND FEMALE BIOLOGY SO WE CAN DO THAT IN THE FUTURE. AGAIN, IF YOU HAVE A RESEARCH QUESTION AND THE CIRCUMSTANCE THAT FALLS FOR WHATEVER NUMBER, JUST LIKE ANY OTHER APPLICATION, YOU DESCRIBE THAT AND YOU PUT THE BUDGET FOR THAT, IT IS NOT BETTER TO DO THE STUDY WE COULD DO IF IT'S NOT EVEN OF QUALITY THAT THE FINDINGS COULD BE DEFINITIVE EVEN FOR THAT COULD CONTEXT. AND I THINK WE CAN'T DO THAT ANYMORE. AND HAVE TO RECOGNIZE THAT THIS IS A REAL ISSUE. >> I THINK IT'S EXTREMELY IMPORTANT THAT THE WEBSITE OR WHATEVER INFORMATION YOU'RE PUTTING FORTH GIVE SOME CLEAR EXAMPLES OF POSSIBLE OUTCOMES OR POSSIBLE WAYS THAT YOU CAN APPROACH INCLUDING MALES AND FEMALES. I THINK IT'S IMPORTANT TO REALIZE THAT ONLY IF YOU YOUR HYPOTHESIS IS THAT SEX CAUSES A DIFFERENCE, ONLY IN THOSE CASES SHOULD YOU POWER IT ENOUGH, YOUR GROUPS OF MALES AND FEMALES, TO TEST THAT. WITH REGARD TO YOUR POINT THAT PEOPLE DON'T HAVE TIME MORE THAN A MINUTE TO DO THAT -- SO I THINK YOU'RE RIGHT, BUT THAT'S WHY IT'S IMPORTANT TO -- THE MOMENT THAT YOU KNOW THIS GROUP COST YOU YOUR FUNDING DI FUND IF F-ING IF FUNDING IF YOU DON'T APPROACH THESE TYPES OF THINGS IN THE RIGHT WAY, YOU'RE GOING TO SPEND ONE MINUTE TO FIGURE OUT HOW TO -- >> I HEAR YOU. >> I JUST WANTED TO SAY HOW IMPORTANT IT IS THAT WE START CAPTURING THIS SIGNAL OF WHERE THERE IS EVIDENCE OF A SEX IT DIFFERENCE OR POSSIBLE SEX DIFFERENCE, EVEN STUDYS THAT WEREN'T POWERED TO BE ABLE TO LOOK AT IT DIRECTLY. THERE IS SO MUCH WE DON'T KNOW ABOUT WHERE THERE MAY BE SIX DIFFERENCES AND SO MUCH -- IT'S A BARRIER TO EVEN PUTTING IN A STUDY WITH A HYPOTHESIS OF A DIFFERENT MECHANISM PATHWAY. SO IN DEMOGRAPHIC RESEARCH, THIS IS HOW WE WERE ABLE TO LOOK AT RACIAL ETHNIC DIFFERENCES IS LOOKING AT A LOT OF STUDIES THAT ALTHOUGH THEY WERE LARGE WERE COMPLETELY UNDERPOWERED FOR THIS, AND IT WAS PART OF A DISCUSSION WE HAD JUST A COUPLE WEEKS AGO AT THE NATIONAL ACADEMY OF SCIENCES MEETING AND WHY WE NEED TO START CAPTURING THIS KIND OF INFORMATION AND WRITING IT CORRECTLY. IT MAY BE THAT I WORK MORE WITH DEMOGRAPHERS AND HELP SERVICES RESEARCHERS, BUT THIS IS NOT A COMPLICATED OR TRICKY CONCEPT FOR THEM TO GET THEIR HEADS AROUND. THEY'RE USED TO HAVING TO TAKE INTO ACCOUNT AND CONSIDER THE ESSENTIALS OF DOING GOOD SCIENCE. IT'S A MATTER OF SAYING THIS IS WHAT HAS TO BE REPORTED BACK IN PROGRESS REPORTS AND OTHER THINGS, AND NEEDS TO BE MADE A STANDARD. SOME OF THEM HAVE WRITTEN ABOUT THINGS ROUTINELY IN STUDIES AND HAD THEM REMOVED BECAUSE OF THE MEDICAL JOURNALS WOULD SAY THAT'S NOT IMPORTANT, USE THIS TO CUT YOUR WORD COUNT. BUT I THINK TAKING NIH -- THE KNOWLEDGE TO GET TO THE FIRST STRETCH OF WHAT ARE SOME IMPORTANT NEXT STUDIES THAT SAY SOMETHING DIFFERENT THAN WHAT THE DOMINANT THEORY HOLDS IN TERMS OF SEX DIFFERENCES. >> DR. BECKER, YOU'RE GOING OH HAVE THE LAST WORD BECAUSE WE ARE OVER TIME AND I DON'T WANT TO CUT INTO YOUR LUNCH BREAK, SO JILL, GO RIGHT AHEAD. >> SINCE SEX AS A BIOLOGICAL VARIABLE IS AN IMPORTANT COMPONENT OF INCREASING THE RIGOR OF OUR SCIENTIFIC PRODUCTIVITY, I THINK IT'S IMPORTANT WE THINK ABOUT THE FIRST TIME YOU INCLUDE FEMALES IN AN EXPERIMENT, IT NEEDS TO BE POWERED TO DETECT WHETHER THERE'S A DIFFERENCE. IF THERE IS NO DIFFERENCE, THEN THE RESEARCH CAN PROCEED AND INCLUDE BOTH MALE THE AND FEMALES, BUT NOT POWERED AT LEAST INITIALLY, SO THAT YOU CAN KNOW WHETHER THERE'S A SEX DIFFERENCE IN A VARIABLE, I THINK IS OH ONLY GOING TO CREATE CONFUSION AND WON'T IMPROVE THE SCIENTIFIC DATA THAT ARE BEING COLLECTED. >> SO MAYBE IN OUR DISCUSSION POINT IN THE OF AFTERNOON AND ON THE PANEL, THESE ISSUE, I'M SURE, WILL COME UP AND WE CAN CONTINUE THE CONVERSATION. I REALLY APPRECIATE THE THOUGHTS THAT ALL OF YOU HAVE SHARED. IT'S VERY, VERY HELPFUL TO US. SO WE'RE GOING TO ADJOURN FOR LUNCH. THOSE OF YOU THAT SENT IN INFORMATION, I BELIEVE YOUR LUNCHES ARE OVER HERE, AND WE WILL RECONVENE AT 1:00 P.M. I WANT TO ACKNOWLEDGE THAT DR. VIVIAN AS JOINED US, WE'LL TALK MORE ABOUT HER THIS AFTERNOON. WE'LL HAVE MORE TIME FOR THAT THIS AFTERNOON. BUT WE'LL SEE YOU BACK HERE AT 1:00. THANK YOU. WELCOME BACK. WELCOME TO OUR AFTERNOON CELEBRATION OF SCIENCE, HONORING 25 YEARS OF RESEARCH AND PROGRESS FROM THE NATIONAL INSTITUTES OFFICE OF RESEARCH ON WOMEN'S HEALTH. 25 YEARS AGO A GROUP OF CONGRESS WOMEN HELD A PRESS CONFERENCE RIGHT HERE AT NIH TO EXPRESS THEIR CONCERNS ABOUT THE LACK OF INCLUSION OF WOMEN IN CLINICAL RESEARCH. ONE OF THOSE CONGRESS WOMEN WAS SENATOR BARBARA MCCOULD SKI O WHO HOPED TO BE WITH US TODAY BUT THERE'S IMPORTANT ACTION GOING ON DOWNHILL SO SHE'S UNABLE TO JOIN BUT WE HAVE A SPECIAL VIDEO INSTEAD OF HER BEING HERE. SENATOR MCULSKY WAS THERE FOR US AT THE VERY BEGINNING AND SHE'S THERE FOR US TODAY. A FEW WEEKS AGO WITH SENATOR SUSAN COLLINS SHE PUT TOGETHER SENATE RESOLUTION 242 CELEBRATING THE 20th ANNIVERSARY OF ORWH. I'M DELIGHTED TO SAY THE RESOLUTION WAS CO-SPONSORED BY ALL 20 WOMEN AND WAS FOLLOWED BY A PARALLEL RESOLUTION PASSED BY THE HOUSE ON REPRESENTATIVES. WE ARE ALSO JOINED BY ANOTHER DISTINGUISHED GUEST, DR. VIVIAN PENN ORIGINAL DIRECTOR OF THE OFFICE OF RESEARCH ON WOMEN'S HEALTH. JOIN ME IN WELCOMING DR. PENN. I'M THRILLED TO TAKE THIS OPPORTUNITY TO ANNOUNCE IN APPRECIATION OF DR. PENN'S YEARS OF DEDICATED LEADERSHIP AND SERVICE TO WOMEN'S HEALTH, NIH ESTABLISHING THE VIVIAN W. PENN SEMINAR SERIES TO BE DIFFER DELIVERED ANNUALLY DURING NATIONAL WOMEN'S HEALTH WEEK. [APPLAUSE] >> WHEN YOU'RE 25 YOU THINK YOU CAN DO ANYTHING AND YOU THINK YOU CAN CHANGE THE WORLD. FOR ORWH IS PAST YEAR ALONE SHOWS PROMESS FOR IMPROVING WOMEN'S HEALTH SUPPORTING STUDY OF BIOMEDICINE. IN 015 WHAT CAN WE SAY? THE 25 YEAR INVESTMENT IN ORWH HAS BEEN A SMART ONE. MANY ADVANCES IN HEALTH FOR WOMEN AND MEN. WE CAN SAY WITH GREAT EXCITEMENT THAT FROM HERE ON OUT, CONSIDERING SEX IS A BASIC BUY LOGICAL VARIABLE TO BE A CORE PIECE OF THE NIH MISSION APPLIED ACROSS NIH INSTITUTES AND CENTERS AND ACROSS DISEASES AND CONDITIONS, NOT ONLY THOSE THAT AFFECT THE (INAUDIBLE). OUR GOAL WITH POLICY TO ENCOURAGE STUDY OF BOTH SEXES WHICH WILL RESULT IN A RICH KNOWLEDGE BASE, THAT CAN BE USED TO INFORM AND IMPROVE THE HEALTH OF WOMEN. WHEN WE ENSURE THAT THE SCIENCES ARE THINKING ABOUT THE ROLES OF ACROSS THE CONTINUUM WE WILL TRULY ACHIEVE INDIVIDUALIZED MEDICINE APPROPRIATE FOR MEN AN WOMEN. WE ARE SO EXCITED FOR THE AFTERNOON AGENDA CAREFULLY CONSTRUCTED TO REFLECT THE RAKE OF ACTIVITIES THAT ORWH SUPPORTS. WE HAVE COMING AND ALL STAR PANEL OF BIOMEDICAL RESEARCHERS TO DISCUSS STUDY OF SEX AS BIOLOGICAL VARIABLE WITH DR. DAVID PAGE AS MODERATOR. WE'LL PIVOT FROM THE PRE-CLINICAL SPACE TO THE CLINICAL SPACE AND DEBUT A NEW ORWH ONLINE RESOURCE TO SUPPORT RESEARCHERS IN THEIR EFFORTS TO ENGAGE RECRUIT AND RETAIN WOMEN IN CLINICAL TRIALS. THANK YOU FOR COMING TODAY TO SHOW YOUR SUPPORT FOR ORWH AND FOR NIH. NOW I WOULD LIKE TO INTRODUCE DR. LARRY TABAK, PRINCIPLE DEPUTY DIRECTOR OF NIH. DR. TABAK PREVIOUSLY SERVED ADS DIRECTOR OF NATIONAL STATE OF DENTAL AND CRANIOFACIAL RESEARCH, PROVIDED LEADERSHIP FOR SEVERAL TRANS-NIH ACTIVITIES INCLUDING THE ROADMAP EFFORTS TO SUPPORT TEAM SCIENCE, THE NIH DIRECTOR'S INITIATIVE TO ENHANCE PEER REVIEW, AND ORWH IMPLEMENTATION OF AMERICAN RECOVERY AND REINVESTMENT ACT. RECENTLY DR. TABAK COORDINATED A TRANS-NIH EFFORT TO ENHANCE THE REPRODUCIBILITY OF SCIENTIFIC FINDINGS AND CURRENTLY LEADING A TEAM DEVELOPING NIH WIDE STRATEGIC PLAN. PRIOR TO JOINING NIH DR. TABAK WAS SENIOR ASSOCIATE DIRECTOR FOR RESEARCH AND PROFESSOR DENTISTRY AND BIOCHEMISTRY AND BIOPHYSICS AS SCHOOL OF MEDICINE DENTISTRY AT UNIVERSITY OF ROCHESTER. DR. TABAK'S RESEARCH FOCUS IS STRUCTURE BIOSYNTHESIS AND FUNCTIONAL GLYCO PROTEINS AN MAINTAINING AN ACTIVE RESEARCH IN THE NIH INTRAMURAL PROGRAM. DR. TABAK, THAW FOR JOINING US TODAY. [APPLAUSE] >> THANK YOU, JANINE. MY POST DOCS WOULD ARGUE ME MAINTAINING AN ACTIVE ROLE IN OUR RESEARCH PROGRAM BUT EVERY TIME I GO TO THE LAB THEY ASK FOR MY ID. I DO WANT TO THANK JANINE FOR AROWING ME TO PARTICIPATE IN WHAT IS A REALLY HISTORIC DAY. YOU DON'T TURN 25 EVERY DAY, SO IT'S REALLY QUITE WONDERFUL. AND IT'S GREAT TO SEE DR. VIVIAN PENN, WHO HAS TAUGHT SO MANY OF US SO MANY THINGS SO GREAT TO HAVE YOU HERE AS WELL. IN ADDITION TO THANKING JANINE AND ORWH STAFF WHO HAVE BEEN NON-STOP AT WORK ON THIS EFFORT, I ALSO WANT TO THANK ORWH ADVISORY COMMITTEE, THOSE WITH US TODAY, AND I UNDERSTAND A NUMBER OF FOLKS PAST AND PRESENT ON THE PHONE. SO THANKS TO ALL OF YOU AS WELL. I THINK AS PART OF THE NIH LEADERSHIP TEAM, I SEE EVIDENCE EACH AND EVERY DAY HOW MUCH NIH SOLVENCY AND ABILITY TO MEET OUR GOALS DEPEND UPON ABILITY TO WORK TOGETHER. IT IS THE GIANTVILLE LARGE. OVER -- GIANT VILLAGE. OVER THE PAST 18 MONTHS, EFFORTS TO ENHANCE THE RIGOR AN REPRODUCIBILITY OF SCIENCE CALLED FOR INPUT AND OLD FASHIONED ELBOW GREASE FROM A BROAD RANGE OF PARTNERS. ONE OF OUR BEST PARTNERS HAS BEENIA JEAN AND HER TEAM AT -- JANINE AND HER TEAM AT ORWH. UNDER JANINE'S LEADERSHIP THIS IS ALLOWING NIH TO REALLY ENABLE NEW DISCOVERIES ABOUT THE ROLE AND INFLUENCE OF SEX ON FEMALE AN MALE BIOLOGY SOJA KNEE, THANK YOU ON BE-- SO, JANINE, THANK YOU FOR THAT, VERY, VERY IMPORTANT. TO EXTEND THE PARTNERSHIP THEME I SHOULD NOTE ORWH CONTINUES TO WORK EFFECTIVELY WITHIN AND OUTSIDE OF HHS, INCLUDING FORMALIZED COLLABORATIONS WITH THE FDA, OW STAKEHOLDERS INCLUDING ADVOCACY GROUPS REPRESENTED HERE IN PERSON OR VARIETY LE ON THE PHONE. THIS TEAM WORK IS NOT JUST NICE, THOUGH IT IS NICE, IT'S ACTUALLY IMPERATIVE. ABSOLUTELY ESSENTIAL TO MAKING THE PROGRESS THAT WE NEED TO ACHIEVE THE NIH GOAL OF IMPROVING HEALTHFUL AMERICANS. I HAVE TO SAY IT'S WONDERFUL TO SEE THE RESEARCH COMMUNITY MOVING BEYOND DISEASES AND WOMEN TO DISEASES IN WOMEN. AND THAT'S REALLY A SEA CHANGE, IT ENABLES INCORPORATION OF WHAT'S REALLY IMPORTANT, IN TERMS OF BOTH CLINICAL AND SCIENTIFIC QUESTIONS THAT NEED TO BE ANSWERED AND HOW BEST TO ANSWER THEM. IF YOU GO BEYOND PRE-CLINICAL RESEARCH, WHERE WE SPENT TREMENDOUS AMOUNT OF ENERGY THIS YEAR IN PARTICULAR, ORWH CONTINUES TO ADDRESS ISSUES CRITICALLY IMPORTANT TO THE HEALTH OF WOMEN, NOT JUST WOMEN'S HEALTH. IT'S BROADER THAN THAT, RANGING FROM INTIMATE PARTNER VIOLENCE TO HEART DISEASE AND STROKE TO CANCER AND IN MANY OTHER AREAS INCLUDING THE COLLABORATIVE WORK OF THE FOGARTY INTERNATIONAL SENOR ON ISSUES RELATED TO GLOBAL HEALTH. CONTINUING VIGILANCE ON INCLUDING WOMEN AND ESPECIALLY WOMEN OF COLOR, IN CLINICAL RESEARCH IS SO VERY, VERY IMPORTANT. THE NEW CLINICAL RESEARCH OUTREACH TOOL KIT IS A GREAT PRODUCT THAT REALLY SHOULD HELP RECRUIT ALL WOMEN INTO CLINICAL STUDIES WHICH IS REALLY CRITICAL TO ENSURE THAT THE RESULTS INFORM THE HEALTH OF ALL WOMEN AND IN PARTICULAR, CASE STUDIES ARE REALLY PROVIDE A REAL WORLD TAKE ON THOSE. FINALLY IT'S IMPORTANT TO STEP BACK AND REMEMBER AT ITS CORE SCIENCE IS A HUMAN SPORT. IT'S A HUMAN ENDEAVOR. A DIVERSE WORK FORCE IS ABSOLUTELY ESSENTIAL IF WE ARE ABLE TO CONDUCT EXCELLENT RESEARCH ORWH SUSTAINED WORK TO ADVANCE CAREERS FOR WOMEN IN BIOMEDICINE BY DEVELOPING P POLICY, COLLABORATING WITH NIH INVESTIGATORS TO STUDY FACTORS THAT AFFECT WOMEN'S ENTRY AN RETENTION IN SCIENCE AND MEDICINE. SO FOR THAT WE ARE VERY GRATEFUL. THANK YOU. I GUESS WITH THAT, THE MOMENT WHEN I WALK IN THE ROOM THERE'S A SLUMPING OF SHOULDERS BECAUSE IT MEANS THE TAUOGENETICIST ISN'T HERE AND YOU GOT ME -- THE TOLLAGE SET CYST -- TALL GENETICIST. I'M GOING TO INTRODUCE A VIDEO OF SENATOR MCULSKY. SO EVERYBODY TOGETHER. SO WITH THAT, I THINK OBVIOUSLY SENATOR MCULSYY NEEDS TO INTRODUCTION TO THIS GROUP. SHE'S AN EXTRAORDINARY LEADER AND ADVOCATE AND EXTRAORDINARY PARTNER. SO MUCH OF WHAT NIH DOES, BUT ONE OF HER REAL PASSIONS IS WOMEN'S HEALTH AND ORWH. SO I THINK THAT'S PROBABLY SUFFICIENT FOR A VIDEO INTRO. SO I WILL TURN IT OVER TO THE VIDEO MYSELFER WHO WILL -- MEISTER. THANK YOU. >> PLEASE JOIN ME IN THANKING DR. TABAK FOR HIS REMARKS. [APPLAUSE] >> HI, EVERYBODY. SAME JACKET. AT MY AGE AND STAGE, WHEN THE JACKET FITS, YOU WEAR IT. RIGHT? WELL, HI, EVERYBODY, IT'S WONDERFUL TO BE BACK IN THE HOUSE OF LET EPITIVES -- REPRESENTATIVES AGAIN WHERE I SERVED TEN YEARS. ON THE ENERGY COMMERCE COMMITTEE AND MARINE AND FISHERIES COMMITTEE AND LOVED IT VERY, VERY MUCH AND WHEN I WAS IN THE HOUSE OF REPRESENTATIVES, THE MARYLAND DELEGATION AT THAT TIME THERE WERE 16 WOMEN IN THE HOUSE AND 25% CAME FROM MARYLAND. IT WAS CONNIE, BYRON, GLADYS THEY WILLMAN AN ME. HOW ABOUT THAT? THAT WAS REALLY AN INCREDIBLE GROUP OF PEOPLE. THIS IS INDEED A FANTASTIC CELEBRATION, I WANT VERY MUCH TO BE HERE, TO JOIN IN MY -- WITH MY COLLEAGUES TO COMMEMORATE. I WANT TO ACKNOWLEDGE ANOTHER SISTER FROM MARYLAND, MY FRIEND ESTEEMED COLLEAGUE CONGRESSWOMAN DONNA EDWARDS. [APPLAUSE] I WANT TO THANK THE COKAL WOMEN'S CAUCUS WOMEN'S ISSUES AS WELL ATZ NIH FOR ORGANIZING THIS MOST -- AS WELL AS NIH FOR ORGANIZING THIS ANNIVERSARY EVENT THAT COMMEMORATES THE PAST, SAYS WHAT WE'RE FIGHTING FOR TODAY AND HOW WE HAVE TO STAND UP FOR THE FUTURE. REMEMBER, SAVER THE PAST, TALK ABOUT WHAT WE'RE FIGHTING NOW, AND STAND UP FOR THE FUTURE. I REMEMBER 25 YEARS AGO I HAD BEEN RECENTLY ELECTED TO THE UNITED STATES SENATE. WHEN I RAN FOR THE SENATE THEY SAID I DIDN'T LOOK THE PART. WELL, FRIEND, THIS IS WHAT THE PART HAS COME TO LOOK LIKE. [APPLAUSE] ON THIS GREAT ANNIVERSARY I WOULD LIKE THE READ A LETTER THAT SPARKED A REVOLUTION. THIS LETTER WAS SIGNED BY PAT SCHROEDER, COBNY MORELLA OLYMPIA SNOW. IT WAS AUGUST, THE GULF WAR HAD BEGUN, GEORGE BUSH THE ELDER WAS IN THE WHITE HOUSE. THE HUBBLE WAS GETTING READY TO BE LAUNCHED. LITTLE DID WE KNOW WE'D NEED THE MOST EXPENSIVE CONTACT REMEMBER IN AMERICAN HISTORY AND WITH SENATOR CASTLE BALM AND I AND COLLEAGUES IN THE HOUSE THERE WAS YET ONE MORE GAO REPORT THAT SAID WOMEN WERE NOT INCLUDE MISDEMEANOR THE PROTOCOLS AT NIH. THAT THE FAMOUS STUDY CALLED MR. FIT, WHOA, WHOA, WHOA, STUDIED 10,000 MEDICAL SCHOOL INTERNS AND RESIDENTS. NOT ONE WOMAN WAS INCLUDED. AND IN THE MEANTIME THE NATIONAL INSTITUTES OF AGING LOCATED IN BALTIMORE HAD JUST COMPLETED A LONGITUDINAL STUDY ON AGING IN AMERICA AND NOT ONE WOMAN WAS INCLUDED. AND I SAID MY GOD STROM THURMAN WAS AGING DIFFERENTLY THAN I WAS. SO WE PUT OUR HEADS TOGETHER ACROSS THE AISLE, AND ACROSS THE DOME AND WROTE THIS FAMOUS LETTER. WE WERE WRITING TO PROPOSE A MEETING. BETWEEN THE MEMBERS OF THE EXECUTIVE COMMITTEE, THE CONGRESSIONAL CAUCUS ON WOMEN'S ISSUES AND KEY GOVERNMENT OFFICIALS TO DISCUSS WOMEN'S HEALTH. WE HOPE THAT THIS MEETING CAN TAKE PLACE AT NIH, AT TEN O'CLOCK. IN ADDITION, WE WOULD LIKE THE PUBLIC TO BE ABLE TO ATTEND. THE PURPOSE OF THE MEETING WOULD BE TO PROVIDE MEMBERS OF THE CONGRESSIONAL CAUCUS TO LEARN WHAT STEPS NIH TAKES TO RESPOND TO THE ISSUES RAISED BY THE GAO REPORT AND ELSEWHERE. AND TO DISCUSS WITH KEY GOVERNMENT OFFICIALS WHAT STEPS MIGHT BE NECESSARY TO STRENGTHEN FEDERAL RESEARCH ON WOMEN'S ISSUES, WE INVITE DR. RUTH KIRSCHSTEIN, BELOVED FRIEND AND COLLEAGUE, SECRETARY SULLIVAN, SURGEON ATTORNEY GENERAL NUVERLO TO PARTICIPATE. THERE WE WERE, IT WAS A HOT STEAMY AUGUST MORNING. I ZIPPED UP IN MY CAR, WHO WAS GETTING OUT BUT CONNIE IN HER CAR RIGHT THERE IN MONTANA COUNTY, -- MONTGOMERY COUNTY, PAT SCHROEDR AND OLYMPIA SNOW, WE PULLED UP, CAMERAS WERE THERE, THE CAMERAS CLICKING, THEY SAID HAVE YOU HEARD? GEORGE BUSH HAS JUST APPOINTED BERNADINE HEELEY AS HEAD OF NIH. WE SAID FIRST STEP BUT NOT THE ONLY STEP. DON'T GIVE US A NEW WOMAN AND THE SAME OLD POLICY. AND WE MET THAT DAY, ACROSS THE AISLE AND ACROSS THE DOME WITH THE KEY SCIENTISTS AND WE LISTENED TO ALL THE RIDICULE. WE COULDN'T DO IT BECAUSE OUR REPRODUCTIVE RHYTHMS WOULD SCREW THE RESEARCH. WE SAID SCREW YOU. THE SECOND THING WAS THERE WAS A DOCTOR THEN AT HOPKINS, SINCE PASSED ON, HAD NOTHING TO DO WITH THAT PART. AND HE SAID WE HAD AGING HORMONES. AND MY RESPONSE WAS HIM, YOU'RE RIGHT, OUR HORMONES RAGE BECAUSE OF GUYS LIKE YOU. TO MOVE ON WITH THE STORY, THAT PARTICULAR DAY WE ASKED WHAT WAS THE SCIENTIFIC REASONING. WE FOUND A LOT OF EXCUSES BUT NO SCIENTIFIC EXPLANATIONS. WE ASKED FOR CHANGES TO BE MADE WE WERE BROADCAST OUT OVER THE ENTIRE NIH CAMPUS. WE ASKED FOR GOAL, WE ASKED FOR TIMETABLES AND WE GOT THE COMMITMENT FROM DR. RAP AND THEN WE BEGAN THE LONG STEP OF MOVING FORWARD. WE ALWAYS HAD A VERY ABLE, ABLE DEDICATED ALLY IN DR. RUTH KIRSCHSTEIN, SHE WAS ALWAYS THERE FOR US EVEN WHEN THE BUREAUCRACY TRIED TO IMPEDE US. WITH DR. HEELEY'S ARRIVAL AND SENATOR CASTLE BALM HELPED WITH THE CONFIRMATION, SHE GOT THERE AND WE SAID DR. HEELEY WE NEED OFFICE OF WOMEN'S HEALTH, NOT A NEW INSTITUTE. WE DON'T NEED AN INSTITUTE ON GENDER, WE WANT TO CUT ACROSS EVERY SINGLE INSTITUTE. WHETHER IT'S AGING, WHETHER IT'S HEART DISEASE, WHETHER IT'S ALL THE OTHER FAB BOWS LAOS INSTITUTES THERE, WE WANT TO BE INCLUDED IN EVERYTHING. AND WE ALSO NEED YOU TO PAY ATTENTION TO BREAST CANCER, WHILE YOUNG WOMEN ARE RACE FOR THE CURE OUT THERE WE NEED TO DO RESEARCH RIGHT HERE. GUESS WHAT, I WENT TO MY COLLEAGUE SENATOR TED KENNEDY, CONNIE AND PAT AND ALL WERE WORKING THE ENERGY AND COMMERCE IN THE APPROPRIATIONS OVER HERE. WE HAD WONDERFUL PEOPLE LIKE JOHN TINGLE AND HENRY WAXMAN, OTHERS ON OUR SIDE. AND AS THE APPROPRIATIONS PROCESS MOVED FORWARD WE PUT IN THE OFFICE OF WOMEN'S HEALTH, WE DID IT BECAUSE OF TED AND NANCY WHEN THE HEALTH EDUCATION COMMITTEE. BECAUSE OF TOM HARKEN AND OR WIN SPECTOR, ACROSS THE AISLE HANDS ACROSS THE AISLE AND THE HOUSE WORKED WITH US. AND THEN AS THAT MOVED FORWARD AND WE ESTABLISHED THAT, I GOT A CALL FROM DR. HEELEY SHE AND I WERE BECOMING CLOSE AS WE WORKED WITH ALL THE ISSUES RELATED TO NIH. SHE SAID SENATOR MCULSCY, I WOULD LIKE TO DO A LONGITUDINAL STUDY ON HORMONE REPLACEMENT. IT IS AN ACCEPTED MEDICAL PRACTICE BUT OUR BASIC ASSUMPTIONS COULD BE WRONG. BUT I CAN'T ASK FOR MONEY BECAUSE OF THE CHAIN OF COMMAND AT OMB AND I SAID I CAN'T DO EARMARKS. THAT'S BEFORE THEY WERE BANNED. BAD MISTAKE. ANYWAY, WE NEVER EARMARKED NIH NOR SHOULD WE. SO THEN I WENT AGAIN TO TED AND TO NANCY, TORULIN AND TO TOM, WE FIGURED A DAY, AGAIN OUR COLLEAGUES IN THE CONGRESSIONAL WOMEN'S CAUCUS WERE RIGHT THERE TO WORK THE AUTHORIZING AND APPROPRIATIONS PROCESS AND WE FOUND A WAY TO DO REPORT LANGUAGE THAT GAVE DR. HEELEY TO DO HER STUDY. YOU KNOW, THE REST HISTORY. WE ESTABLISHED THAT WONDERFUL NATIONAL -- THE OFFICE OF WOMEN'S HEALTH. THAT HAS MEANT SO MUCH IN RESEARCH, HAS MEANT SO MUCH TO INCLUDE YOUNG WOMEN SCIENTISTS WHO NEVER GOT A SHOT, NEVER HAD A CHANCE OR OPPORTUNITY. NOW WE SEE NOT ONLY OUR BELOVED DR. VIVIAN PENN WHO DR. HEELEY APPOINTED, AND HAD THE FORESIGHT TO DO THAT, PUCKED HER OUT OF HER GREAT JOB AT HOWARD UNIVERSITY AND BROUGHT HER TO NIH. SO WE HAD BERNADINE, WE HAD DR. RUTH AND WE HAD DR. VIVIAN. WHAT A TRIO. WHAT A TURBO TEAM. WHAT A TURBO TEAM. DR. RUTH ISN'T WITH US ANY MORE NOR IS DR. HEELEY. BUT IN DR. HEELEY'S FAMED CLOSING DAYS WHEN I KNEW SHE WAS QUITE ILL I CALLED HER. BECAUSE I READ IN THE NEW YORK TIMES THAT DAY THAT BREAST CANCER RATES HAS BEEN REDUCED IN AMERICA BY 5% AND I CALLED -- 15%. I CALLED DR. HEELEY, IF I GET EMOTIONAL PLEASE BEAR WITH ME BECAUSE WHEN I THINK ABOUT WHAT WE DID AND CALLING DR. HEELEY I SAID BERNADINE, WE DID A LOT OF GOOD THINGS, BUT THAT OFFICE OF WOMEN'S HEALTH IS WHAT YOU CHAMPIONED, WHAT RUTH CHAMPIONED WHAT VIVIAN MADE SURE REALLY DID HAPPEN, THE HORMONE STUDY, CHANGED MEDICAL PRACTICE. WHEN THEY SAID WHAT DID THE WOMEN EVER DO? YOU CAN SAY YOU CAN SAY WE SAVED LIVES, WE SAVED THEM A MILLION AT A TIME SO DEAR FRIENDS WHEN YOU COMMEMORATE THIS ANNIVERSARY THAT BEGAN WITH THIS LETTER, BEGAN WITH HANDS ACROSS THE DOME, HANDS ACROSS THE AISLE. NOT WOMEN VERSUS MEN BUT MEN AN WOMEN WORKING TOGETHER FOR THE COMMON GOOD, WE REALLY MADE HISTORY AND WE CHANGED HISTORY. NOT ONLY FOR INSTITUTIONS, BUT FOR THE LIVES OF HUNDREDS OF THOUSANDS OF WOMEN. SO GOD BLESS YOU FOR WHAT YOU HAVE DONE BUT THAT'S WHAT WE DO NOW, LET'S GET THE MUCH AND FEDERAL BUDGET, LET'S GET THAT MONEY IN THERE FOR THE LIVES YOU HELP AND LET'S DO THAT FOR TODAY AND STAND UP FOR TOMORROW. THERE IS MORE BREAKTHROUGHS TO COME AND IF WE HAVE TO BREAK A FEW KNUCKLES TO BE ABLE TO DO IT OR A FEW BARRIERS, SO BE IT. ALL OF YOU, GOD BLESS YOU. GOD BLESS THOSE ABSENT FRIENDS TODAY AND THE FACT OF LET'S KEEP THE SPIRIT OF HANDS ACROSS THE AISLE, HANDS ACROSS THE DOME, HELPING HANDS FOR THE AMERICAN PEOPLE. THANK YOU, VERY MUCH. [APPLAUSE] >> DO YOU HAVE A COMMENT? LET ME JUST SAY BEFORE YOU COTHAT LET ME JUST SAY THAT VIDEO WAS FROM THE HILL NOT TOO LONG AGO AND ENERGY IN THE ROOM WITH WAS AMAZING AND I THINK YOU SEE FROM THAT VIDEO THE INCREDIBLE WOMEN AND INCREDIBLE ENERGY THAT THEY STILL HAVE. THAT PROPELLED US WHERE WE ARE TODAY IN OUR 25th ANNIVERSARY. SO ANOTHER ROUND OF APPLAUSE, DR. BERNADINE HELLEY, DR. RUTH KIRSCHSTEIN AND DR. VIVIAN PENN FOR STARTING SOMETHING. I HOPE THAT WE CAN CONTINUE IN A WAY THAT MAKES THEM ALL PROUD. PLEASE JOINT ME. [APPLAUSE] >> DR. STEINER. >> THAT WAS JUST AMAZING. IT AIDE ME THINK OF WHICH I OFTEN THINK IS OFFICE OF RESEARCH ON WOMEN'S HEALTH IS INCREDIBLY -- IT'S BROADENED ITS VIEW BY ADDING MORE BASIC RESEARCH INCLUDING BOTH -- I THINK UNBELIEVABLE THAT THAT HAS HAPPENED BUT I THINK THE OFFICE SHOULD BE ABLE TO GET -- IT NEEDS MORE RESOURCES, IT DESERVES MORE RESOURCESFUL THESE DREAMS ARE BIG AND REALITY OCCUR EVERY DAY, EXCITING THINGS ARE HAPPENING WITH WHAT THE OFFICE IS DOING, I THINK IT SHOULD BE GETTING MORE FUNDING. >> AS A A SPECIAL GOVERNMENT EMPLOYEE, AS A GOVERNMENT EMPLOYEE, I AM PROHIBITED FROM LOBBYING AS ARE YOU TODAY. SO ON ANOTHER DAY YOU MAY DO THINGS AS A PRIVATE CITIZEN. DR. PENN CAN COMMENT. >> SINCE I ONLY HAVE ARE HONORARY TITLE I'M NOT EMPLOYED BY NIH I CAN PROBABLY SPEAK TO SOMETHING. YOU CANNOT DO ANYTHING IN TERMS OF LOBBYING FOR MONEY, IDENTIFYING YOURSELF AS A MEMBER OF THE ADVISORY COMMITTEE WHICH YOU KNOW. BUT KNOWING HOW MECHANISM WORKS YOU KNOW HOW JANINE SCHMITZ GIVEN PARAMETERS OF WHAT SHE SHOULD STRIVE FOR THEN THAT GOES TO THE DIRECTOR OF NIH AND THEN IT GOES THROUGH THE DEPARTMENT DOWNTOWN AND THEN IT GOES TO OMD AND THEN ENDS UP AT WHITE HOUSE, THEN IT GOES TO CONGRESS. I THINK I USED TO DO IT ANYWAY AND DIDN'T GET CAUGHT BUT I NOW SPEAK VERY OFTEN WHEN PEOPLE TALK PROGRESS HOW IMPORTANT IT IS TO PAY ATTENTION TO NOT JUST ORWH BUT THE BUDGET OF NIH IN GENERAL BECAUSE WE REALLY WANT RESEARCH ON WOMEN'S HEALTH AND SEX AND GENDER ISSUES NOT JUST WITHIN ORWH BUT ACROSS THE NIH. SO YOU CAN TAKE THOSE CONCERNS TO YOUR LOCAL CONGRESS FOLKS IN THE SENATE AND THE HOUSE THROUGH YOUR PROFESSIONAL ORGANIZATIONS TO GET THEM TO SPEAK. AND OFTEN MAKING A POINT TO SOMEONE IN CONGRESS ABOUT A CONDITION THAT AFFECTS SOMEONE CLOSE TO THEM OR THEIR CONSTITUENCY BECAUSE THEY SEE VOTES. SO IF YOU CAN MAKE THE POINT TO THEM THAT THIS IS SOMETHING THAT WILL AFFECT OR BRING GRANTS TO THE INSTITUTIONS IN THEIR DISTRICT, THAT IT CAN HAVE IMPACT. IT'S UNFORTUNATE ADVISORY COMMITTEE IS IN FACT ONE DIRECTIVES FOR THIS ADVISORY COMMITTEE IN THE LEGISLATION, IS THE ADVISORY COMMITTEE SHOULD ENSURE THAT THERE ARE FINANCIAL -- I HAVE FORGOTTEN HOW TO WORD BUT IN ESSENCE ONE OF YOUR RESPONSIBILITIES TO MAKE SURE THERE IS FUNDING FOR THESE PROGRAMS IN WOMEN'S HEALTH. BUT YOU ARE RESTRICTED WITH WITHIN THE SYSTEM BUT YOU HAVE MORE INFORMATION SO AS LONG AS YOU DON'T IDENTIFY YOURSELF BEING PART OF THE ADVISORY COMMITTEE, I ENCOURAGE YOU TO DO IT. I DO IT EVERY CHANCE I GET. AND I ENCOURAGE YOU TO DO THAT, IT MAKES THE POINT WHEN LOCAL FOLKS, IF YOU HAVE REPRESENTATIVE WHOSE ARE ON THE APPROPRIATIONS COMMITTEE, EVEN MORE IMPORTANT BUT EVEN IF YOU DON'T GETTING SOMEONE TO SPEAK UP YOU KNOW THERE HAVE THOUGH THEY DON'T EARMARK YOU KNOW OFTEN YOU SEE LANGUAGE IN THE REPORT LANGUAGE WHICH DIRECTS FUNDING TO DISEASES THAT WE KNOW ARE RARE OR NOT THAT COMMON BUT SOME IMPORTANT CONSTITUENT WHO HAS GOTTEN TO A MEMBER OF CONGRESS HOW IMPORTANT THIS IS AND MAKES A DIFFERENCE HOW IT WORKS. SO I THOUGHT I COULD ADD THAT SO THAT JANINE DOESN'T GET IN TROUBLE BUT I DON'T GET A PAYCHECK SO I CAN SAY IT. >> BEFORE THE NEXT COMMENT I WANT TO ACKNOWLEDGE AND RECOGNIZE DR. NANCY LEE, DIRECTOR WOMEN'S HEALTH AND DEPARTMENT AND ACKNOWLEDGE SEVERAL COORDINATING COMMITTEE RESEARCH WOMEN'S HEALTH AROUND THE ROOM AND FORMER MEMBERS, SO THANK YOU ALL FOR BEING HERE. >> SO I HAVE THE OPPORTUNITY TO (INAUDIBLE) IT WAS A LITTLE TAME FOR HER. BUT I THINK THIS IS A REAL OPPORTUNITY HERE. FIRST THANK YOU VIVIAN FOR YOUR LEADERSHIP, I THINK A LOT OF PEOPLE WILL DO THAT TODAY, THANK YOU AGAIN, JANINE AND YOUR STAFF FOR YOUR LEADERSHIP. THIS IS AN OPPORTUNITY TO ACKNOWLEDGE SENATOR MC CCURSKY AND PIONEERS IN THIS MOVEMENT TO 25 YEARS AND I DON'T KNOW EXACTLY WHAT HAS BEEN CREATED IN HER NAME BUT CERTAINLY AN OPPORTUNITY TO CREATE A LECTURE ON LEADERSHIP FOR WOMEN AND SEEMS LIKE THAT IS AN ISSUE WE HAVE NOT REALLY ADDRESSED AND MAYBE THAT'S SOMETHING WE MIGHT WANT TO DO AS COMPANION TO THE TALK THE SEMINAR SERIES, ASSOCIATED WITH DR. PENN. PARDON? (OFF MIC) >> I WOULDN'T SAY INSTEAD OF. YOUR HEELS ARE HIGHER. I'M GENERALING A BIT BUT WE HAVEN'T HAD OPPORTUNITY TO HAVE CONVERSATIONS ABOUT THAT. IF WE'RE JUST NOW GETTING AROUND TO THIS, IN 25 YEARS, TO HAVE A SPECIFIC LECTURE THERE'S PROBABLY A ROLE FOR MORE THAN ONE. I SEE CLOE OVER THERE NODDING HER HEAD. SO I'M PUTTING THAT OUT THERE AS AN AGENDA ITEM AND HAPPY TO MAKE A MOTION ON THAT. AFTER I HAVE MORE DATA. TO FOLLOW-UP, IT WOULD BE NIGHTS TO HAVE AN UNDERSTANDING, AND I RECOGNIZE THAT SORT OF NEW TO THIS BUT HAVE AN UNDERSTANDING WHAT THE FTEs ARE FOR THIS PARTICULAR ORGANIZATION AS WELL AS BUDGET AND WHETHER THAT'S CONSISTENT WHAT OTHER TYPES OF GROUP OF SAME SIZE HAVE. THE OTHER THING IS, IT'S BEEN BRIEFLY TOUCHED ON. THE WHOLE CONCEPT OF -- AS WE START MOVING FORWARD WE HAVE INCREASINGLY DIVERSE POPULATION OF WOMEN, WOMEN OF COLOR, WE HAVE NOT REALLY UNDERSTOOD THEM, FROM A SCIENTIFIC PERSPECTIVE, FROM LEADERSHIP PERSPECTIVE, I THINK TOES ARE THINGS THAT WE NEED TO PUT ON THE TABLE FOR -- WE HAVE A LARGER COHORT. MORE ROBUST CONVERSATION. >> >> THANK YOU, DR. GREEN. >> >> I WANT TO ENDORSE WHAT YOU WERE SAYING ABOUT SENATOR MCCULSKY, I HAPPEN TO BE A NEW POST DOC AS A GERONTOLOGY RESEARCH CENTER IN AUGUST 1990 ADMINISTRATORS CAME BACK FROM THAT MEETING UP ENDED. THE WINDOWS OF THE GRC WAS WIDE OPEN, THEY FINALLY LEVELED CREATED A LEVEL PLAYING FIELD FOR THE WOMEN SCIENTISTS IN THE BUILDING, FINALLY OUR VOICES WERE BEING HEARD. SO I CAN'T UNDERESTIMATE, WE CAN'T UNDERSTATE WHAT THESE WOMEN DID WITH THEIR MORAL COURAGE, PASSION AND COMMITMENT TO THIS. >> THANK YOU, DR. PALMER. IF WE HAVE A LITTLE EXTRA TIME, WE DON'T ALWAYS GET EXTRA TIME SO THAT WILL WORK OUT WELL BECAUSE I DON'T THINK THAT WE REALLY FINISHED OUR CONVERSATION OUR DISCUSSION. OF THE PREVIOUS. GO AHEAD. (OFF MIC) >> THINK ABOUT IT. DON'T GET IT RIGHT THE FIRST TIME. >> >> CAN I ADD A COMMENT TO HELP WITH YOUR THOUGHTS, DR. GREEN, HELP YOU WITH YOUR THOUGHTS. SO AS WE THINK ABOUT THIS, I THINK WHAT WE SAW IN THIS VIDEO AND IN PARTICULAR WHAT YOU SAW, DR. PALMER, IS THAT QUESTION KNEW WE HAD THE SCIENTIFIC RIGOR BEHIND, SO WE UNDERSTOOD THAT BUT WHAT WAS ALWAYS THE CHALLENGES AND CONTINUES TO BE FOR WOMEN, IS THE VOICE. THERE IS A CERTAIN LEADERSHIP DEVELOPMENT THAT GOES WITH THIS SO I THINK IT'S A WONDERFUL OPPORTUNITY AS WE BRING FORWARD DR. PENN'S LECTURE SERIES, THAT WE NEED TO CALL OUT WHAT IS THE OTHER PART THAT'S NEEDED. WE NEED TO CONTINUE TO ENCOURAGE TO USE THEIR VOICE AND A LEADERSHIP SERIES NAMED SENATOR MCCULSKY WOULD BE SOMETHING TO PUT FORTH THAT MESSAGE. SO I DON'T THINK YOU DO IT IN SPITE OF YOU DO IT IN ADDITION TO BECAUSE YOU'RE MAKING A STATEMENT ABOUT THE TWO PARTS THAT ARE NEEDED. YOU ALWAYS GOING TO NEED THE CORE, THE FOUNDATION SCIENTIFIC RIGOR AND ACKNOWLEDGMENT, THE IMPORTANCE OF THAT BUT ALSO KNOW SOMETIMES CARRY THE WATER FURTHER SO THE MESSAGE IS HEARD AND PEOPLE FEEL EMPOWERED TO DELIVER THE MESSAGE PARTICULARLY WHEN THERE IS A ARE THE OF BARRIERS PUT FORTH TO THE SIGNIFICANCE OF IT. THIS IS WHY WE KEEP HAVING THE SAME DISCUSSION ABOUT SEX AS BIOLOGICAL VARIABLE OR THE SEXES OR WHATEVER IT IS, WE KEEP HAVE HAG DISCUSSION, THERE ARE BARRIERS SOMETIMES WE CAN'T SEE PEOPLE PUT IT UP AND DISGUISE AS MANY THINGS, LEADERSHIP LECTURE SERIES, GIVEN THIS VOICE WOULD BE ALSO A SIGNIFICANCE. OKAY? >> THANK YOU. ABSOLUTELY THANK YOU VERY MUCH. DR. MONTGOMERY RICE. SO WE'LL CONSIDER ALL OF THOSE THOUGHTS AROUND THE TABLE I SEE SEVERAL THINKING CAREFULLY ABOUT THAT. AND WE COULD GO AHEAD AND SOME OF THIS TIME NOW PICKING UP OUR PREVIOUS DISCUSSION WE HAVE ALSO ANOTHER TIME SLOT FOR DISCUSSION AFTER THE PANEL WHICH IS SCHEDULED TO START AT 2:45. SO LET'S GO AHEAD AND SPEND SOME TIME NOW DISCUSSING SOME OF THE KEY ISSUES. ADVISORY COMMITTEE MEMBERS WANT TO BRING FORWARD. AND PICK UP WHERE WE LEFT OFF ON THE STUDY BOTH SEXES SEX DIFFERENCE, WHAT DOES THAT MEAN? AS ASPECT OF RIGOR. I WANT TO HIGHLIGHT THAT THE PHRASE STUDY BOTH SEXES DIFFERENT FROM INCLUDE BOTH SEXES. I CHOSE THAT CAREFULLY. YOU CAN INCLUDE WOMEN AND WE DO THAT IN CLINICAL RESEARCH BUT WE DO NOT SEE THE ANALYSES OR THE DATA FOR THAT INCLUSION. FEWER THAN A HIDER OF SOME OF THE PUBLICATIONS THAT HAD WOMEN, LARGE NUMBERS OF WOMEN, PHASE 3 CLINICAL TRIALS SUPPORTED BY NIH, FEWER THAN A THIRD OF THOSE HAVE SEX SPECIFIC DATA OF ANY SORT. NOT EVEN TALKING ANALYSIS, ANY IN THEIR PUBLICATION. WE DON'T CONTROL PUBLICATIONS. WE ARE WORKING WITH THE GENERAL EDITORS BUT THAT IS AN AREA WE NEED PARTNERSHIP AND FOLKS TO COME ALONGSIDE TO HELP US WITH THAT. DOESN'T MATTER IF YOU INCLUDE WOMEN BUT YOU DO NOT REPORT THE DATA WHEN I SAY WHAT DO I WANT? STUDY BOTH SEXES SCIENTIFICICALLY APPROPRIATE THE DO SO BECAUSE OUR MISSION IS TO TURN DISCOVERY INTO HEALTH, FOR HUMAN HEALTH AND HUMANS COME IN THESE TWO FORMS. THAT'S WHAT I MEAN. STUDY BOTH SEXES, CAN MEAN WE'RE GOING TO STUDY THIS PROBLEM IN WOMEN, WE NEED THEY CAN MACK SURE HEART FAILURE CLINICAL TRIAL INCLUDES SEX RELEVANT INCLUSION CRITERIA BECAUSE WE KNOW THIS IS A DISEASE THAT PRESENCE DIFFERENTLY. SHOULD THE INCLUSION CRITERIA BE THE SAME? COULD BE SEX STRATIFIED RANDOMIZATION SO WE MAKE SURE WE DON'T FILL UP THE SLOTS AND SAY OH, I DIDN'T REALIZE WE HAVE 90% FILLED, OUR TARGET WE DIDN'T MEET OUR TARGET FOR SEX. THERE ARE WAYS TO STUDY SEX THINK ABOUT IT AND I KNOW WHEN SCIENTISTS LOOK AT IT THAT WAY AS A SCIENTIFIC ISSUE AND ALSO AN ISSUE OF RELEVANCE THAT WE TALKED ABOUT THIS MORNING, THERE'S THE Rs OF REPRODUCIBILITY, THERE THEY ARRIVE THREE Rs BUT THE R THAT I THINK IS MOST IMPORTANT FOR WHAT WE'RE TALKING HERE IS RELEVANT. SO ANIMAL MODEL BASED ON NOT THE WAY THAT THE HUMAN DISEASE PRESENCE, ARE YOU USING WRONG AGE OF ANIMAL, IS NOT RELEVANT TO ADULT ONSET STROKE. IS THAT WHAT WE SAID WE WERE GOING TO BE DOING? SO SHARE THOSE COMMENTS AS WE TALK OTHER ISSUES THAT OTHER PEOPLE HAVE POINTS TO MAKE. SO DR. NELSON. GREAT. THANKS. >> THIS PICKS UP A LITTLE CONVERSATION BEFORE, WE TALKED AT OTHER MEETINGS OUT WHERE EVERYBODY STARTS DOING THIS, THEY HAVE THESE DATA, BUT NOT A PUBLISHABLE PIECE OF DATA. WHERE DOES THAT GO? AND BEING SOMEONE WHO DOES META ANALYSES AND PROVIDING DATA ACROSS STUDIES, THINGS ARE HIDDEN AWAY AND YOU CAN PICTURE THAT HAPPENING, JUST PART THAT DATA IN SOME FILE AND NO ONE WOULD SEE IT SO HOW CAN WE BRING THAT FORTH? IT'S NOT PUBLISHABLE, NOT SHOWN IN A SPLIT FORM IN THAT SENSE. HOW DO WE GET TO THAT DATA? KNOWING THE TREND ANALYSIS, EVEN IF WE DON'T KNOW STATISTICALLY SIGNIFICANT DIFFERENCES POOLING THE DATA IS USEFUL, SO MANY OPPORTUNITIES MISSED, JUST HIDDEN AWAY SOMEWHERE. AND WITH DATA SHARING WE SHOULD BE ABLE TO GET TO THAT. I THINK THAT IS THE MISSING LINK IN THIS, IT'S NOT ALL BEING PUBLISHED IN A JOURNAL BECAUSE A LOT NOT PUBLISHABLE PERHAPS BUT JUST FINDING SOLUTION TO THAT TO GET US SOMEWHERE. >> I'M SURE THERE'S AREA STRATEGIES TO GET THAT DATA OUT. I WOULD SAY I DON'T BUY ANCILLARY DATA IS NOT AN OPTION FOR EITHER CLINICAL OR PRE-CLINICAL, NOT -- THAT'S NOT AFFECTING YOU HIGH DI, YOU KNOW THAT. WE HAVE GOTTEN THAT PUSH BACK THAT WE CAN'T PUT THE DATA THERE T IT'S THEIR ISSUE. THE DATA NEED TO BE MADE AVAILABLE. WE ALL AGREE AND HOW CAN WE COTHAT IN MEANINGFUL WAY THAT'S SUSTAINABLE, MAKE SENSE FOR PEOPLE TO ACCESS. FOR CLINICAL AND PRE-CLINICAL THERE'S DIFFERENT SOLUTIONS FOR THOSE SITUATIONS. LOVE TO CONTINUE THAT CONVERSATION AND WORKING WITH STAKEHOLDERS I DON'T THINK NIH WILL BE ABLE TO DO THIS ALONE. WE DON'T FUND ALL THE RESEARCH. WE FUND QUITE A BIT BUT NOT ALL. THE KNOWLEDGE IS OUT THERE AND WE'RE LOSING OUT ON THAT INFORMATION. THE WORK WAS DONE, WE DON'T HAVE ACCESS TO THE DATA, THAT'S JUST A SHAME. WE'RE NOT REAPING THE FULL BENEFIT OF THE INVESTMENT. >> CONNIE. >> SO HOW DO WE GET TO LIKE I'VE BEEN IN MEETINGS WITH OUR LOCAL HOSPITAL RESEARCH ADMINISTRATORS THAT SAY WE'RE NOT GOING TO TAKE WOMEN OF CHILD BEARING YEARS IF WE CAN AVOID IT IN CLINICAL TRIALS BECAUSE OF LIABILITY IN CASE THEY GET PREGNANT, WHATEVER, THEY MIGHT BLAME IT ON US. SO THEY MAY NOT WANT TO PUBLISH THE TRIALS IN CLASSICAL WAYS WHERE THERE'S EARMARK BUT WHAT ABOUT THE SPONSORS? IS THERE A WAY POLICY TO REACH WHEREAS THAT'S NOT ACCEPTABLE? >> SO RESEARCH NIH FUNDED. >> IT'S NOT -- PRIVATE. >> BEYOND OUR PURVIEW. >> I KNOW IT IS IN THE USUAL SENSE BUT LET'S PUT ON OUR THINKING HAT BECAUSE WE WANT TO SOLVE THAT PROBLEM FOR WOMEN. EVEN IF IT IS NIH FUNDED HOW CAN WE MAKE IT AN ATTRACTIVE TO TAKE THAT STANCE? >> WHAT I CAN SAY, WE SPONSORED A COUPLE OF YEARS AGO WORKSHOP INCLUSION OF PREGNANT WOMEN IN CLINICAL RESEARCH. THIS IS AN ISSUE IN PREGNANT WOMEN, THAT IS A VERY PREGNANT WOMEN, NOT WOMEN WHO MIGHT GET PREGNANT BECAUSE IF YOU TALK WOMEN WHO MIGHT GET PREGNANT THAT'S A LOT OF PEOPLE, SOME ARE IN THIS ROOM. SO ARE WE GOING TO EXCLUDE ALL THOSE PEOPLE? NO COMMENT ON THAT. SO YOU'RE TALKING PHARMA SPONSORED RESEARCH. HOWEVER, IF WE CAN DEVELOP DESIGNS AN APPROACHES AN STRATEGIES THAT MIGHT BE RELEVANT TO A LOT OF PLACE, THAT'S ONE THING WE CALLED FOR IN THAT MEETING. THIS SITUATION CALLS FOR A DIFFERENT KIND OF STUDY DESIGN THAN ARE ROUTINE STUDY DESIGNS. WE NEED TO BE LEARNING MORE FROM THE ELECTRONIC HEALTH RECORDS, WOMEN WHO GET PREGNANT, AS RECENT AUTHOR CITED SICK WOMEN GET PREGNANT AND PREGNANT WOMEN GET SICK. WE HAVE VERY LITTLE DATA WHICH TO MAKE TREATMENT DECISIONS. BUT ELECTRONIC HEALTH RECORDS IS ONE SOURCE OF DATA ON PEOPLE ON WOMEN WHO BECOME PREGNANT, THERE IS SOME INFORMATION THERE, THE FDA ALSO HAS A VARIOUS REPORTING MECHANISMS THAT COULD BE MINED AND SO THERE ARE OTHER THINGS THAT COULD BE DONE, THIS IS AN AREA OF INTEREST TO US. THE NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT IS AWARE OF THAT IS ALSO VERY INTERESTED IN THIS AREA. SLIGHTLY DIFFERENT ISSUE. AND SO I THINK MY STAFF WILL KILL ME IF WE TAKE ON ANYTHING ELSE NOW, >> FDA MAYBE THE KEY THERE. >> SOMEBODY HERE FROM FDA THAT CAN COMMENT ON THE PREGNANCY REGISTRY? (OFF MIC) DO YOU MIND COMMENT SOMETHING (OFF MIC) -- COMMENTING? (OFF MIC) (OFF MIC) >> >> I WANT TO RECOGNIZE DEB CALDRON TO THE OFFICE OF WOMEN'S HEALTH FDA. SORRY I DIDN'T RECOGNIZE YOU. >> THANK YOU. WE OBVIOUSLY FDA WOULD LIKE TO GET AS MUCH INFORMATION ON WOMEN WHO TAKE MEDICATION DURING PREGNANCY. WE ENCOURAGE THE USE OF PREGNANCY REGISTRIES, WE HAVE A WEBSITE AND WE WOULD LIKE WOMEN TO ENROLL BUT THAT ENROLLMENT IS VOLUNTARY. SO WE'RE DOING WHAT WE CAN TO OUTREACH, ENCOURAGE PARTICIPATION. I'M NOT SURE THAT I'M ANSWERING YOUR QUESTION. >> THE OTHER ISSUE IS THE FDA DOES NOT REQUIRE THAT WOMEN OF CHILD BEARING AGE BE EXCLUDED FROM CLINICAL RESEARCH BY PHARMA. >> NO. >> NOT SURE. >> I THINK IF THAT WAS THE OLD -- THERE WAS A TIME THAT WAS AN ISSUE FROM THE FDA PERSPECTIVE BUT THAT IS -- I DON'T KNOW IF YOU'RE TALKING YOUR HOSPITAL BEING CONCERNED ABOUT LEGAL ISSUES. OF COURSE THOSE ARE AN ISSUE FOR ALL OF US. >> FINANCIAL LIABILITY AND LEGAL ISSUES, I WONDER IF FDA HAD REPORTING STRUCTURE THAT MAKES THEM JUSTIFY EXCLUDING THE GROUP THE WAY NIH DOES, THAT WOULD BE HELPFUL. >> THE FDA DOES NOT EXCLUDE. WOMEN OF CHILD BEARING AGE. >> VALERIE. >> I HAVEN'T SAT ON THE FDA ADVISORY PANEL FOR A NUMBER OF YEARS. THERE'S BEEN LOTS OF I DISCUSSION -- FIRST THERE'S NOT A PHARMA TRIAL THAT I EVER PARTICIPATED IN THAT HAVE WOMEN OF CHILD BEARING THAT DIDN'T HAVE A PREGNANCY TEST REQUIRED BEFOREHAND. THAT'S NO TRIAL. AND I HAVE DONE MOST OF THEM. MOST WERE INTERVENTIONS WITH MEDICATIONS AND THERE WERE SOME OF THEM THAT THERE WAS A CONTRAINDICATION TO USING MEDICATION IF PREGNANT. PART OF WHAT HAPPENED AT YOUR INSTITUTION, MY RECOMMENDATION WOULD BE MORE EDUCATIONAL PROCESS FOR THEM TO UNDERSTAND FIRST ALL WOMEN WHO WERE -- WHO ARE STILL IN THEIR REPRODUCTIVE AGE ARE RISK FOR PREGNANCY. SO IF YOU ARE WORRIED ABOUT THAT, GET A PREGNANCY TEST BUT THAT'S STILL NOT # HUNDRED% BECAUSE YOU MIGHT NOT HAVE CAUGHT IT AT THAT TIME, IT TAKES 30 DAYS TO ENROLL IN THE TRIAL SO THERE'S GOING TO BE SOME POTENTIAL RISK. SO MOST OF IT COMES FROM EDUCATION, THE FDA AND DR. PENN OFFICE OF RESEARCH WOMEN'S HEALTH, Y'ALL HAVE A PUBLICATION THAT CAME OUT IN 2010 THAT TALKED ABOUT THE INCLUSION OF PREGNANT WOMEN IN CLINICAL TRIALS AND IMPORTANCE OF INCLUDING PREGNANT WOMEN IN APPROPRIATE TRIALS SO THERE'S CERTAIN TRIALS IT'S APPROPRIATE TO INCLUDE WOMEN AND IF YOU KNOW THE CON THAT INDICATION TO MEDICATION -- CONTRAINDICATION TO MEDICATION IN A PREGNANT WOMEN AND IT STILL BENEFITS WE DEFINITELY WOULD HAVE THAT WOMAN IN THE TRIAL SO A MATTER OF FINDING THE LITERATURE AND HAVING SOME EDUCATIONAL SERIES WITH THE LEADERSHIP AT THE HOSPITAL OR THE INSTITUTION. >> YOU HAVE TO COME TO A MICROPHONE IF YOU WANT TO MAKE A COMMENT. PLEASE FEEL FREE TO COME UP. >> WANT -- WE WERE ACTUALLY TALKING ABOUT FDA LEVEL TOO, IT'S NOT JUST PREGNANCY, LIKE AS A PHYSICIAN, YOU'RE VERY CONCERNED WITH OUR NEW THERAPIES FOR EXAMPLE FOR STROKE, LOOKING AT THINGS LIKE H DABBING ACETYL ATORS AND EPIGENETIC MEDICATION. THESE CAN HAVE A CONSEQUENCE ON A WOMAN WHO MAYBE PREGNANT 20 YEARS AFTER THE TRIAL IS COMPLETED. SO THAT IS ONE THING THAT ALSO CAN DECREASE ENROLLMENT FOR WOMEN IS CONCERNED ABOUT THEIR EXPOSURE, YOU HAVE EVERY EGG YOU HAVE AND IT WILL BE EXPOSED TO THAT PHARMACEUTICAL. SO I THINK BEYOND JUST AN ACTIVE PREGNANCY FOR WOMEN THERE'S ALSO THIS FEAR THEY'LL HAVE EXPOSURE FOR A FUTURE PREGNANCY. I SEE THAT. >> I THINK THERE'S ALSO IMPORTANCE OF OUR REGISTRIES SO THAT WHEN EVERYBODY WHO IS IN A CLINICAL TRIAL PARTICULARLY WOMEN OF REPRODUCTIVE AGE, IT'S IMPORTANT THAT WE HAVE REGISTRY, GOING BACK TO LARGE DATA ANALYTICS 25, 30 YEARS FROM NOW, LOOKING AT CHILDREN OF THOSE CHILDREN, WE WILL KNOW WHETHER OR NOT THERE WAS LEVEL OF EXPOSURE. THAT'S WHY IT WAS IMPORTANT THAT PEOPLE REALLY DO HAVE THE -- USE REGISTRATION. >> THANKS FOR THOSE COMMENTS. DR. PENN. >> I'M HAVING TO RESTRAIN MYSELF, LET ME COMMENT IN RESPONSE, BECAUSE WHAT I'M HEARING, THE VERY COMMENTS WE HEARD IN '91, '92, WHEN THE LAW WAS PASSED IN '93, WE IMPLEMENTED IN '94, IT'S DIFFICULT TO BELIEVE I'M HEARING THE SAME THING NOW THAT WE HEARD BACK 20 SOMETHING YEARS AGO. BUT LET ME ADD A CAVEAT. I HEARD ON THE NEWS THIS MORNING THERE'S MORE ATTENTION BEING PAID TO PERHAPS THE ROLE OF SPERM IN DETERMINING ILLNESSES IN THE PROGENY. SO I WONDER IF WE ARE THEN HEAR PERHAPS WE SHOULD NOT PUT MEN IN CLINICAL TRIALS BECAUSE THEIR SPERM MAYBE EXPOSED TO MEDICATIONS THAT WE DON'T KNOW HOW THEY MAY AFFECT THE OFFSPRING FOR THE NEXT OR THE FOLLOWING GENERATION. YOU CAN REALLY DRAW A PARALLEL HOW WE AVOID THAT BUT MAYBE THAT NEWS WILL CARRY OVER AND MAKE US THINK AGAIN ABOUT OUR CONCERNS ABOUT -- I THOUGHT I WOULD THROW THAT IN FOR JUST SOMETHING TO THINK ABOUT. >> THE MORE WE LEARN ABOUT EPIGENETICS MODIFICATIONS AN EFFECT OF THE ENVIRONMENT, THERE'S WIDESPREAD ISSUES THERE. I THINK WE JUST NEED TO THINK THEM THROUGH AND DEVELOP STRATEGIES, BECAUSE THOSE AREN'T GOING AWAY. WE NEED TO DO WHAT WE CAN TO LEARN AS MUCH AS WE CAN. AND PREGNANT WOMEN THAT'S A SPECIAL AREA OF CLINICAL RESEARCH PARTICIPATION THAT IS IMPORTANT TO US AND I THINK WE HEAR YOU, THAT IS IMPORTANT TO THE GROUP HERE TOO SO WE'LL TAKE IT BACK AS ONE AREA THAT YOU EXPRESS INTEREST. ARE THERE OTHER AREAS OF INTEREST THAT ANYBODY WOULD LIKE TO BRING UP? >> THANKS, JANINE, I WOULD BE INTERESTED IN GOING AHEAD WITH THE PANEL THOUGH I THINK THE POINT YOU RAISED ABOUT CONTINUING DISCUSSION ABOUT DIFFERENCE BETWEEN INCLUDING ANIMALS OR CULTURES VERSUS STUDYING SEX DIFFERENCES, IN THE PANEL MAYBE THEY WILL BE EXAMPLES WHERE THAT COULD COME UP THAT IT WOULD BE PARTICULARLY IMPORTANT TO PAY ATTENTION TO. AND THAT WAY WE CAN LEARN WHAT PANELS SAY BUT ALSO RESERVE TIME TO THINK ABOUT THAT ISSUE, BECAUSE I THINK IT'S A CONTINUING ISSUE FOR US ALL. THANK YOU. >> GREAT. SO IF WE WERE SCHEDULED FOR A BREAK RIGHT BEFORE THE PANEL. IT'S 2 O'CLOCK. SO WE CAN TAKE A BREAK OR GO RIGHT INTO THE PANEL AND -- ARE YOU READY TO GO WITH THE PANEL, LOOK LIKE PEOPLE ARE READY TO GO? DAVID, YOU READY? YOU NEED A COUPLE OF MINUTES? ALL RIGHT. SO WE'LL GO AHEAD AND ALLOW OUR COLLEAGUES TO GET SET UP FOR THE PANEL, RECOGNIZING THEY WEREN'T QUITE READY SO WE'LL CERTAINLY BE PATIENT WITH THEM AND YOU CAN RESITUATE AND DO A LITTLE BIOBREAK IF YOU NEED. OK GREAT. WE'RE GOING TO GET STARTED HERE. THANK YOU, DR. PAGE, SORRY ABOUT THAT. I WANT TO INTRODUCE DR. JENNIFER PLANK, ONE NEW ADDITION TO OFFICE OF WOMEN'S RESEARCH AND HEALTH STAFF. JENNIFER. >> GOOD AFTERNOON. IT'S MY PLEASURE TO INTRODUCE DR. DAVID PAGE WHO WILL BE MODERATING THIS AFTERNOON PANEL DISCUSSION ON SEX AS A BIOLOGICAL VARIABLE. DR. PAGE IS PROFESSOR OF BIOLOGY AT THE MASSACHUSETTS INSTITUTE OF TECHNOLOGY AND DIRECTOR OF THE WHITE HEAD INSTITUTE AT MIT. DR. PAGE HOLDS AN M.D. FROM HARVARD MEDICAL SCHOOL AND HE IS RECIPIENT OF NUMEROUS WADES AND ACCOLADES INCLUDING -- AWARDS AN ACCOLADES NOT LIMITED TO THE MCARTHUR FELLOWSHIP AND ELECTED TO THE NATIONAL ACADEMY OF SCIENCES, AND AT THIS POINT I WOULD LIKE TO TURN THINGS OVER TO DR. PAGE TO INTRODUCE OUR PANELISTS. >> THANK YOU, JENNIFER. SO WE HAVE GOT WE'LL TAKE ABOUT AN HOUR WITH THIS SESSION. IT'S AN OPPORTUNITY TO THINK BROADLY THROUGH THE LIVES, CAREERS AND INTERESTS OF OUR FOUR PANEL ITSELFS TO THINK BROADLY AT SEX AS A BIOLOGICAL VARIABLE AND THINK THE SCIENTIFIC OPPORTUNITIES WITH RESPECT TO BETTER UNDERSTANDING HUMAN HEALTH AND DISEASE THAT ARE POSED BY EXISTENCE OF TWO SEXES. SO WHAT WITH WE WILL DO FIRST IS ASK -- I'M GOING TO ASK EACH OF OUR FOUR PANEL ITSELFS AFTER I HAVE INTRODUCED THEM, GOING TO ASK EACH FOUR PANELISTS TO TAKE ABOUT THREE MINUTES AND SHARE WHATEVER COMMENTS THEY MIGHT HAVE TO GIVE A LITTLE INSIGHT TO THEIR OWN CAREERS AND HOW THOSE CONNECT TO THE QUESTIONS OF SEX DIFFERENCES, THEN AFTER THAT I WILL PROBABLY FOLLOW-UP WITH SOME QUESTIONS AND IF YOU WELCOME REALLY RAMBUNCTIOUS, I MAY ALLOW ONE OF YOU OR TWO OF YOU TO INTERJECT A QUESTION AS WELL. MAYBE WE'LL HAVE THE PANEL ASKING QUESTIONS. WITHOUT FURTHER ADIEU LET ME INTRODUCE OUR PANELISTS. SO HEATHER CROSS IS PROGRAM LEADER OF THE ANTI-BACTERIAL RESISTANCE LEADERSHIP GROUP AT DUKE UNIVERSITY. SHE WILL EXPLAIN SHE HAS HAD ANOTHER LIFE THAT PRECEDES THAT THAT IS ALSO VERY RELEVANT TO QUESTION ON SEX DIFFERENCES. DOWN ON THE END BARBARA STRANGER IS AN ASSISTANT PROFESSOR AT UNIVERSITY OF CHICAGO. IN THE DEPARTMENT OF MEDICINE IN THE SECTION OF GENETIC MEDICINE. NEXT TO ME HERE IS ART ARNOLD, DISTINGUISHED PROFESSOR AND UCRA DEPARTMENT OF PSYCHOLOGY AND HE IS WELL KNOWN AS EDITOR IN CHIEF OF THE JOURNAL BIOLOGY OF SEX DIFFERENCES WHICH IS PUBLISHED BY THE ORGANIZATION FOR THE STUDY OF SEX DIFFERENCES. AND THIRD DOWN THE LINE, LOUISE MCCULLOUGH WHO RECENTLY BECAME CHAIR OF THE DEPARTMENT OF NEUROLOGY AT THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT HOUSTON. SO WE HAVE A VERY DISTINGUISHED PANEL HERE, AGAIN I WILL ASK EACH OF OUR FOUR PANELISTS TO SAY SOMETHING ABOUT THEIR OWN CONNECTIONS PROFESSIONALLY TO THE QUESTION OF SEX DIFFERENCES, STARTING WITH HEATHER. >> GOOD AFTERNOON. SO I HAVE AS DAVID SAID TWO PHASES TO MY RESEARCH CAREER, MY CURRENT ONE I'M PROGRAM LEADER ANTI-BACTERIAL RESISTANCE LEADERSHIP GROUP, AN NIH FUNDED NETWORK ABOUT 6 # MILLION DOLLARS AND RISING AS WE GET ADDITIONAL EVERY YEAR, THIS PROMISE IS FINANCIAL YEAR 2016 MUCH COMES THROUGH WE MAY GET THROUGH THE INITIATIVE. SOMEWHAT RELEVANT TO SEX DIFFERENTS, THERE RESEARCH IN THE AREA BUT MOST IMPORTANTLY RELEVANT FOR INCLUSION. THE PIONEERING TRYING TO GET WOMEN IN CLINICAL RESEARCH STUDIES. OF THE TEN WE JUST PUBLISHED IN OUR INCLUSION REPORT FOR THE PROGRESS REPORT FOR OUR GRANT WE HAVE BETWEEN 42 AND 55% WOMEN WITH EXCEPTION OF ONE TRIAL AND COMPLICATED UTI WHICH WE'RE PLANNING 80% WOMEN EXPECTED. WE STUDY WEATHER PROBLEMS WE DON'T KNOW -- STUDY WHAT'S EASIEST TO DO SO LIVING THE DREAM OF HARD WORK THAT PEOPLE HAVE PUT FORTH FOR MANY, MANY YEARS. MY PRIOR RESEARCH CAREER BASIC RESEARCH REALM IN CARDIOLOGY AND I WORK WITHTY SHAH MURPHY AT NHLBI WHICH SEVERAL OF YOU KNOW AND WE WERE LOOKING AT MYOCARDIAL INFARCTION AND WAYS -- MECHANISMS LEADING TO CELL DEATH VIA CALCIUM ACCUMULATION. ONE PROPOSAL WAS SODIUM CALCIUM EXCHANGE INVOLVED. DR. ARNOLD'S COLLEAGUE KEN PHILLIPS AT UCLA HAS TRANSGENIC MICE CALCIUM EXCHANGE MICE, HE SAID I'M SORRY, YOU HAVE TO TAKE SOME FEMALES TOO. SO WE LOOKED AND THERE WAS A REMARKABLE DIFFERENCE. WHICH LED TO HOW FEMALE COULD BE PROTECTED BY MYOCARDIAL INFARCTION BY VARIOUS PATHWAYS. TRANSGENIC MICE WE LOOKED AT KNOWING THERE WAS SEX DIFFERENCE IF THAT MODEL WE LOOKED AT OTHER MODELS AND WE WOULD HAVE COME WITH REMARKABLY DIFFERENT CONCLUSIONS HAD WE NOT LOOKED AT BOTH SEXES SO IT'S INCREDIBLY IMPORTANT AND BOTH FROM THE CLINICAL WORLD AND FROM THE BASIC SCIENCE WORLD, NEAR AND DEAR TO MY HEART AND HAS PROVEN A VERY IMPORTANT AREA. >> THANK YOU, HEATHER. LET ME NOW ASK BARBARA TO TELL US ABOUT SHARE HER PERSPECTIVES HERE. >> THANK YOU VERY MUCH FOR GIVING ME THE CHANCE TO BE HERE. SO I AM ONE OF THE LUCKY RECIPIENTS OF SOME OF THE SUPPLEMENTAL FUNDING THROUGH COMMON FUND AND THROUGH SOME OTHER MECHANISMS. MY LAB IS PRIMARILY COMPUTATIONAL STATISTICAL GENETICS AND GENOMICS WE STUDY COMPLEX DISEASE BUT ALSO GENETICS OF TRANSCRIPTIONAL VARIATION SO WE ARE MEMBERS OF THE ANALYTIC GROUP, THE CONSORTIUM, IF YOU'RE NOT FAMILIAR THAT, THIS IS THE GENOTYPE TISSUE EXPRESSION PROGRAM WHERE WE ARE ASSOCIATING GENERAL TICK VARIATION AND HUMAN POPULATIONS WITH VARIATION IN TRANSCRIPTIONAL LEVELS. SO THIS IS AN NIH COMMON FUND PROJECT. THAT IS SAMPLING TISSUES POSTMORTEM TISSUES FROM A THOUSAND INDIVIDUALS SO WE HAVE CHANCE TO ASK QUESTIONS OF CONTEXT SPECIFICITY OF ACTION OF SPECIFIC POLYMORPHISMS. THAT PROJECT WAS DESIGNED THE LOOK ACROSS TISSUES FOR HOW GENETIC VARIANT MIGHT HAVE A DIFFERENT FUNCTION AND A DIFFERENT TISSUE. FROM BUT THE SAMPLE IS MALES AND FEMALES. SO WE HAVE A REALLY NICE OPPORTUNITY TO ASK THE QUESTION, CAN A SPECIFIC GENETIC POLYMORPHISM HAVE A DIFFERENT EFFECT IN MALES AND FEMALES AT THE TRANSCRIPTIONAL LEVEL? AND THAT'S DIFFERENT THAN ASKING IT IN THE CONTEXT OF DISEASE, WHERE MAYBE YOU COULD DO A SEX STRATIFIED GENOME WIDE ASSOCIATION STUDY BUT THAT'S ONE PHENOTYPE YOU'RE LOOKING AT, WITH LOOKING AT WHOLE GENOME TRANSCRIPTIONAL PROFILES, YOU HAVE GOT 20,000 PHENOTYPES TO REALLY ASK HOW OFTEN DOES THIS KIND OF EFFECT CONTACT SPECIFICITY EFFECT HAPPEN? AND WHERE WE FIND THOSE DO THEY EXPLAIN DIFFERENCES IN DISEASE PHENOTYPE WHERE IS WE KNOW THERE ARE SEX DIFFERENCES BUT EVEN IN TRAITS WHERE THERE MAY NOT BE MARKED DIFFERENCES BUT THE SEX SPECIFIC EFFECTS EXPLAIN MORE DISEASE HERITABILITY IN QUESTIONS LIKE TESTIMONY WE HAVE ALSO SOME PHARMACO GENOMIC QUESTIONS LOOKING AT SEX DIFFERENCES AND ADVERSE EFFECTS AND GENETIC BASIS OF ADVERSE EFFECTS BETWEEN MALES AN FEMALES. THERE A CENTER AT THE UNIVERSITY OF CHICAGO THE CONTY CENTER FOR COMPUTATIONAL NEUROPSYCHIATRIC DISEASE, WE'RE MINING LARGE DATA SETS TO CHARACTERIZE DIFFERENCES IN DISEASE PHENOTYPES, ACROSS THESE VERY LARGE ELECTRONIC MEDICAL RECORD COLLECTIONS. THEN TRYING TO INCORPORATE OUR WORK ON TRANSCRIPTIONAL VARIATION IN TO DISEASE MAPPING STUDIES THERE. >> THANK YOU, BARBARA. I'LL NOW ASK ART TO SHARE HIS PERSPECTIVE. Q. I WANT TO START WITH SOMETHING DR. CLAYTON SAID EARLIER WHICH IS THAT EVERY CELL HAS A SEX. WHICH IS TRUE. THE DURING THE 20th CENTURY MOST RESEARCH POINTED TO THE SIMPLE IDEA THAT THE SEX OF THE CELL IS IMPOSED ON IT FROM THE OUTSIDE. BY GOD INIAL SECRETIONS, WITH REGARD TO DISEASE PHENOTYPES OR -- BY GONADAL DIFFERENCES. MOST BECAUSE BECAUSE MALES HAVE TESTOSTERONE AND FEMALES HAVE ESTROGEN AND PROGESTIN. SO I START STUDYING SEX 40 YEARS AGO IN THE BIRD BRAIN AS BASIC BIOLOGIST AND I WAS FINDING MY BIRDS WEREN'T OBEYING LAWS OF THE 20th CENTURY WITH REGARD TO SEXUAL DIFFERENTIATION AS DEVELOPED PREDOMINANTLY IN RESEARCH ON MAMMALS SO WE WERE INTRIGUED WITH THE IDEA IT WASN'T JUST HORMONES THAT WAS IMPOSING SEX FROM THE OUTSIDE BUT FROM COMING FROM WITHIN THE CELL FROM CELLS OWN NUCLEUS, IT MATTERED WHETHER THE CELL WAS XX OR XY. SO WE TO TEST THAT IDEA, WE LEFT (INAUDIBLE) WHICH ARE NOT GENETICALLY TRACTABLE AND WENT TO STUDY MICE AND TOOK ON MOUSE MODELS DEVELOPED BY PAUL AND ROBERT LEVEL BADGE WHICH THE X -- THE SEX CHROMOSOME CONTENT OF THE CELL IS MANIPULATED INDEPENDENTLY OF WHAT KIND OF GONADS THE MOUSE HAS SO IN THESE MODELS SUCH AS THE FOUR CORE GENOTYPES DR. CLAYTON MENTIONED YOU CAN MAKE XX AND XY FEMALES WITH OVARIES OR XX AND XY MALES SO WE TRY TO KEEP HORMONES CONSTANT SO THAT WITH WE CAN SEE WHAT DIFFERENCE IT MAKES WHETHER YOU HAVE ONE OR TWO X CHROMOSOMES IN YOUR NUCLEUS. OR WHETHER YOU HAVE A Y CHROMOSOME OR NOT. IN THE BEGINNING WE ARE -- OURSELVES WERE QUOTIENT SURE THERE WOULD BE ANY DIFFERENCES, BUT WE ARE SURPRISED TO FIND IN NUMEROUS DISEASE MODELS THAT IN FACT IT DOES MAKE SOMETIMES QUITE A BIG DIFFERENCE. SO WE HAVE COLLABORATED WITH OTHERS INCLUDING DR. MCCULLOUGH WHO WILL SPEAK IN A MINUTE, WHO DIDN'T FIND SEX DIFFERENCES IN HER SYSTEM IS ALL HORMONES BUT OTHER COLLEAGUES, AT UCLA FOUND THAT SEX CHROMOSOMES INFLUENCE MOUSE MODEL OF MULTIPLE SCLEROSIS. KAREN WOOLEY FOUND A SECOND X CHROMOSOME MAKES THE MOUSE FATTER UNDER SOME ENDOCRINE CONDITIONS. A SECOND X CHROMOSOME INCREASES RISK, THE PROBLEM OF CARDIAC ISCHEMIA REPERFUSION INDUSTRY, CARDIAC ISCHEMIA REPERFUSION INJURY. AT UCLA. AND WE ALSO FOUND SOME Y CHROMOSOME EFFECTS, (INAUDIBLE) AT UCSF FOUND A PROTECTIVE EFFECT OF X CHROMOSOME SO THIS IS A NEW IDEA TO US THAT THE NUMBER OF X CHROMOSOMES THAT YOU HAVE DOES HAVE QUITE A SIGNIFICANT IMPACT ON DISEASE PROGRESSION SO THIS IS THE KIND OF WE'RE WORKING ON FINDING THE X GENES THAT PROTECT OR HARMFUL, ET CETERA. >> THANK YOU. FINALLY TURNING TO LOUISE. >> SOME PEOPLE WOULD SAY MY RESEARCH IS BROAD. MANY WOULD SAY UNFOCUSED. I'M STROKE NEUROLOGIST BUT ALSO A NEUROSCIENTIST AND STARTED DOING CELLULAR STUDIES SO I'M VERY INTERESTED IN SEX DIFFERENCES AND HAVE BEEN FOR SOME TIME. THERE'S A HUGE SEXUAL DIMORPHISM WE SEE IN STROKE. SO THAT'S ELDERLY DISEASE WHERE -- CLINICAL DISEASE WHERE OLD WOMEN DO WORSE THAN MEN EVEN IF YOU AGE MATCH THEM. THAT'S A LOT OF PROBABLE REASONS FOR THIS BUT GETTING INTO THE ANYTIMETY GRITTY OF WHY THERE MAY BE MORE RISK IS WE STARTED LOOKING AND GOING BACK TO THE LAB AND TRYING TO FIND IN CELL CULTURES WHAT THEIR DIFFERENCE IF YOU EXPOSE XX CELLS VERSUS XY CELLS OR CELLS DERIVED FROM MICE, OR WE HAVE DONE IT IN HUMANS DO THEY RESPOND DIFFERENTLY TO STRESS, WE USE OGD, STROKE IN A DISH, YOU CAN PREPARE CELLS AND THIS IS -- GETS BACK TO THE FUNDAMENTAL CELL DIFFERENCE. SO IT'S NOT A SOCIETAL THING OR A COMPLIANCE THING, THESE CELLS ARE DIFFERENT SO IF YOU TAKE XX CELLS AND XY CELLS, SPECIFICALLY NEURON AND EXPOSE TO ISCHEMIC INSULT THE XX CELLS ARE PROTECTED SO THEY DO NOT DIE, AS QUICKLY AS MALE CELLS. NOT EVEN JUST THAT, THE MALE CELLS XY CELLS WERE ISCHEMIC SENSITIVE, THIS IS SHOWN IN ASTROCYTES ENDOTHELIUM, LIVER CELLS AND SPLEEN CELLS SO THIS IS NOT A UNIQUE FEATURE OF NEURONS. HOWEVER NEURONS ARE POORLY REGENERATIVE SO THEY ARE IMPORTANT TO ME BECAUSE THEY ARE HARD TO REGENERATE BUT IMPORTANTLY THE CELLS DIE BY DIFFERENT MECHANISMS. SO YOU WERE MENTIONING THIS MORNING THE DISEASE YOU MAY END UP WITH STROKE, YOU MAY HAVE THE SAME INJURY, IF YOU GIVE CELLS GLUCOSE OXIDATION DEPRIVATION THEY DIE, BUT THE WAY THEY DIE DIFFERS AND THAT'S IMPORTANT BECAUSE IF YOU TAYLOR A MEDICATION OR MAKE A MEDICATION TO PREVENT THAT CELL DEATH, THAT MEDICINE THAT WORKS IN MALES DOES NOT WORK IN FEMALES. AND WE FOUND A WHOLE SET OF DRUGS THAT WAS EFFECTIVE IN BEING DEVELOPED FOR STROKE THERAPY THAT WORKED VERY WELL IN XY CELLS AND DID NOT WORK AT ALL IN XX CELLS. THEN WE MOVE THAT INTO A MOUSE MODEL AND FOUND THE SAME EXACT THING, THIS DRUG THAT WAS TARGETING CELL DEATH AND WORKED GREAT IN MALES DID NOT WORK IN FEMALES AND MADE THEM WORSE. WHEN YOU POOL THAT DATA THE DRUG DOESN'T WORK AND YOU THROW IT OUT. THAT'S NOT EFFICIENT. WE COULD HAVE MARKETED IT FOR MALES AND I DO HAVE -- THIS WAS A DIFFICULT CONCEPT TO GET ACROSS TEN YEARS AGO AND THEY CAME OUT USING ONE OF THESE DERIVATIVES IN A TRIAL IN EUROPE AND ASIA AND THEY HAVE NOW REPORT THERE HAD IS A SEX SPECIFIC EFFECT, THE DRUG HELPS MEN, IT DOESN'T HELP WOMEN. SO THIS WAS PREDICTED. IF WE TAYLOR OUR MODELS CLINICALLY WE CAN CAPITALIZE ON THIS B AND MAKE BETTER DRUG FOR PATIENTS. >> THANK YOU. LET ME FOLLOW WITH A QUESTION. WERE YOU SAYING THIS PARTICULAR DRUG THE EVENS YOU HAD SEEP IN CULTURED CELLS OR ANIMAL? >> WE SAW IT ORIGINALLY IN A DERIVATIVE, A PARP INHIBITOR SO FEMALES ARE MORE SENSITIVE TO CASPASE CELL DEATH BECAUSE THE GENES ON THE X CHROMOSOME ARE IMPORTANT INHIBITORS OF CASPASE, IT'S SET UP THAT WAY SO WE USE A DERIVATIVE IN CELLS, FOUND IT TO BE TRUE -- >> IN CULTURE HUMAN CELLS. >> CULTURE CELLS, MOVED INTO ANIMAL MODEL AND USE IT A DRUG CALLED PJ-34 AS WELL AS ANOTHER PARP INHIBITOR YOU MAY HAVE HEARD OF CALLED MENA SIGH CLEAN, IT WAS FOUND RELATIVELY INEFFECTIVE IN A TRIAL IN THE U.S. AND NOW TRIAL THAT WAS JUST REPORTED WITHIN THE PAST MONTH THEY FOUND THAT THERE WAS WHEN THEY DIFFERENTIATED BY SEX THERE WAS A BENEFIT IN MEN AND NOT IN WOMEN. >> WHEN -- AND YOU DID YOUR STUDIES IN CULTURE CELLS YOU DID XX AND XY CELLS. >> CORRECT. WE HORMONE STRIPPED THEY WILL APPROXIMATE CHARCOAL STRIPPED THE MEDIA THEN LOOKED AT HIP CAM PAL IN THEIR ENVIRONMENT VERSUS CULTURED NEURONS SEPARATELY. THIS IS NOW SHOWN IN OTHER LABS FOR THINGS LIKE ASTROCYTES, ENDOTHELIUM AND NON-BRAIN CELLS AS WELL. WE'RE FINDING RECENTLY VERY DRAMATIC DIFFERENCES IN IMMUNE CELLS AND OOH A THAT'S WHERE IT GETS TO INTERACTION WITH AGE. WE SIMPLY CANNOT IGNORE AGE IN MODELS AND THAT'S BACK TO WHY WE FOUND SOMETHING IN THE CORE GENOTYPE THAT WAS DIFFERENT, AGE HAS A HUGE IMPACT ON VASCULAR HEALTH SO IN MY MODELS IT'S IMPORTANT NOT TO STUDY CELLS IN A DISH OR YOUNG ANIMALS BUT ALSO TO LOOK AT AGED ANIMALS THAT NO LONGER HAVE HORMONAL SECRETION. >> A LITTLE FURTHER, WHEN YOU TO THOSE CULTURES, YOU ARE LOOKING AT -- DO YOU -- IN THOSE SORTS OF EXPERIMENTS DO YOU USE TRANSFORMED CELL LINE? ARE YOU ALWAYS USING -- >> WE TRY TO USE PRIMARY SLICES OR CULTURES BECAUSE TRACK FORMED CELL LINES HALF THE TIME ARE VERY UNSTABLE, THEY HAVE SO MANY MUTATIONS, IT'S KIND OF ALLOWED THEM TO BE PASSAGED SO MANY TIMES. SO THESE ARE PRIMARY. WE STARTED USING HUMAN SAMPLES INCLUDING SOME LEUKOCYTES SO ONE THING THAT'S EASY TO GET FROM HUMANS AND HUMANS POST STROKE IS YOU CAN GET BLOOD SAMPLES AND YOU CAN LOOK AT LEUKOCYTES AND WE'RE NOW PLATING THOSE OUT GROWING THOSE OUT AND DOING FLOW SIGH COMETRY TO DECIDE WHAT ARE THE DIFFERENCES. BECAUSE CLEARLY THE NEUROIMMUNE INTERACTION IN STROKE AND INFLAMMATION, IS ONE OF BIGGEST PREDICTORS OF OUTCOME. >> GREAT. ALREADY -- WE HAVE HEARD FROM OUR FOUR PANELISTS BRIEF COMMENTS AND REALIZE THERE'S A HUNDRED ISSUES IN PLAY. WE HAVE FOUR PEOPLE, FOUR CAREERS, THEY ENDED UP IN THE SEX DIFFERENCES SPACE, PROBABLY FOR VERY DIFFERENT REASONS, GOING TO GUESS A BUNCH FAIRLY ACCIDENTAL, ART BLAMED IT ON SOME BIRDS. THEN WE HAVE ALL SORTS OF QUESTIONS. SO I THINK WE WILL HOPEFULLY TOUCH UPON A FEW OF THESE ISSUES. ONE OF THE QUESTIONS SOMETHING I CARE DEEPLY ABOUT AND MANY OF YOU DO I THINK ARE COMPARATIVE STUDIES. WE USE MODEL SYSTEMS ALL THE TIME. A QUESTION I WOULD LOVE TO HEAR I THROW OUT TO THE WHOLE PANEL, AND I SUSPECT THAT A BUNCH OF YOU WOULD BE PREPARED TO ADDRESS THOSE. IS QUESTION OF CROSS-SPECIES COMPARABILITY WHEN CONSIDERING SEX DIFFERENCES IN HEALTH AND DISEASE AND HOW DO YOU TAKE ON THE QUESTION WHETHER TO EXTRAPOLATE FROM A WOMAN TO A MOUSE? >> YOU CAN'T. USUALLY THE OTHER WAY, IT'S IMPORTANT TO GO BOTH WAYS. FIND A QUESTION -- FIND A QUESTION STUDYING WOMEN AND ASK THE MOUSE, THE WHAT THE ANSWER IS. I GO BACK TO SEE IF IT'S RIGHT IN WOMEN. STUDY SECTION WE RECENTLY HAD DISCUSSION, ARGUMENTS ABOUT, WHEN COMPARABILITY. THE POINT OF COMPARATIVE RESEARCH IF YOUR FOCUS IS HUMAN HEALTH WHICH IT IS IN THIS ROOM RIGHT NOW, THE WHOLE PURPOSE OF COMPARATIVE RESEARCH TO GET BRIGHT IDEAS THAT MIGHT BE TRUE OF HUMANS. AND BY STUDYING MICE OR DROSOPHILA OR C ELEGANS OR SONG BIRDS, WE MIGHT GET GENERAL PRINCIPLES THAT WILL BE INFORMATIVE, NOT ALL WILL BE INFORMATIVE BUT THERE'S SIMPLISTIC VIEW IN NIH REVIEWERS AND MY OPINION IF THE MOUSE ISN'T -- DOESN'T LOOK IN SOME SUPERFICIAL WAY LIKE THE WOMAN, SAY IN THE CONTROL OF OVULATION OR ANY PHYSIOLOGICAL OR DISEASE PROCESS, THEN YOU DON'T WANT TO STUDY THE MOUSE BECAUSE IT'S NOT RELEVANT. THAT'S WRONG BECAUSE WE WANT TO UNDERSTAND MOUSE AS A SYSTEM AND UNDERSTAND THE EMERGENT PRINCIPLES THE EMERGENT IDEAS. THE EMERGENT IDEA THAT I -- THAT CAME -- THAT I WAS STRUCK WITH STUDYING BIRDS WAS THAT GOD INIAL HORMONES WEREN'T EXPLAINING SEX DIFFERENCES SO IT MIGHT BE SEX CHROMOSOME GENE, I WAS READING DAVID PAGE AND OTHERS STUDYING GOD INIAL GENES AND GO TO A SYSTEM TO TRY TO ADDRESS THAT. COMPARATIVE RESEARCH IS ENORMOUSLY IMPORTANT. BIRDS HAVE A BIGGER SEX CHROMOSOME EFFECTS THAN OTHER TAXA BECAUSE THEY DON'T COMPENSATE WELL. THEY'RE SEX CHROMOSOMES. IN ANY CASE WE ACCIDENTLY DISCOVERED A SYSTEM WHERE HORMONE SYSTEM -- HORMONE ANSWER WAS NOTS TRUE BECAUSE WE HAVE STUDY IN BIRDS AND WE THEN TAKE IT TO MICE AND ACTUALLY APPLY IT INTO DISEASE MODELS AND FIND OUT THAT IT'S ACTUALLY RELEVANT TO DISEASE. THE COMPARATIVE APPROACH IS GIVE US A LOT OF GREAT IDEAS. >> SO GREAT BEGINNING. I ACTUALLY MAYBE WE CAN JUST HELP ILLUSTRATE THIS AND DRAW IT OUT BECAUSE I'M NOT SURE I CAN ANSWER THIS QUESTION. WE HAVE FOUR PANELISTS UP HERE, INTERESTED IF YOU CAN EACH JUST IDENTIFY THE SPECIES THAT YOU DO YOUR RESEARCH ON. SO I THINK HOW MANY STUDY HUMANS? WE GOT THERE'S A QUESTION MARK. HUMAN RIGHTS. SOMETHING LITTLE QUESTION MARK. HOW MANY UP HERE STUDY RODENTS? WE GOT THREE -- AND BIRDS. ALL RIGHT. HOW ABOUT OTHER -- ANY OTHER VERTEBRATE SYSTEM STUDIED UP HERE? AMONG THE RODENTS HOW MANY MICE DO WE HAVE? HOW MANY RATS DO WE HAVE? OKAY. ALL RIGHT. A LITTLE BIT OF FLICKERING OF HANDS AND ART ALREADY TOLD US IT'S NOT JUST DECIDING THAT A SYSTEM IS COMPARABLE OR NOT, WE GET IDEAS SO ANY OTHER PANELIST REFLECTIONS HOW DO YOU THINK ABOUT IN THE CONTEXT OF YOUR OWN RESEARCH WORK THAT YOU HAVE DONE, HOW DO YOU THINK ABOUT THE INNER PLAY IN YOUR OWN MIND AND MINDS OF COLLEAGUES AMONG THE DIFFERENT SYSTEMS? STUDY SEX DIFFERENCE? >> QUICK COMMENT, I AGREE # HUNDRED% BECAUSE A MOUSE IS NOT HUMAN AND ANY STRETCH OF THE IMAGINATION BUT IT'S SMALL AND CHEAP AND SIMPLE AND YOU GET TRANSGENIC VERSIONS AND IT GIVES A LOT OF IDEAS. THE QUESTION YOU'RE ASKING IN FIRST PLACE IS RELATED TO OBSERVATIONS IN HUMANS. SO YOU WANT TO BE ASKING THAT QUESTION AND USING THAT MODEL IF IT WASN'T REFLECTING SOMETHING YOU WERE TRYING TO STUDY RELATIVE THE HUMANS. TO TWIST THAT QUESTION A LITTLE BIT, BIGGER QUESTION, WHY ARE WE DOING TO PRE-CLINICAL STUDIES ONLY ON MALE ANIMALS AND RUNNING INTO PHASE 1 CLINICAL TRIALS OF MALES AN FEMALES. WHETHER RELATED OR NOT, WHATEVER MODEL MAY OR MAY NOT BE RELATED TO HUMAN BUT TAKING THAT PRE-CLINICAL DATA GOING INTO CLINICAL TRIALS AND IT'S RIGHT NOW THAT QUESTION WE'RE ASKING WHY WE'RE NOT LOOKING AT BOTH. >> HEATHER, LET ME PIN YOU DOWN A LITTLE BIT. YOU MADE A GENERAL YOU FRAMED A PROVOCATIVE QUESTION THERE DOING ANIMAL STUDIES IN ONE SEX THEN MOVING TO HUMAN STUDIES IN BOTH SEXES GIVE AN EXAMPLE MAKE IT CONCRETE FOR US. >> PRETTY MUCH, EXCLUSIVELY FROM PLACES WHERE INSTITUTIONS HAVE ISSUES ENROLLING FEMALES MOST STUDIES NOW ARE 50/50, HIGH SAMPLE SIZE, CLINICAL TRIALS AND WHY EXCLUDE HALF THE POPULATION? ESPECIALLY UPON FURTHER ONES IN QUESTION. AS FAR AS SPECIFIC FINDINGS THAT HAVE BEEN DETRIMENTAL? >> I'M ASKING FOR SPECIFICITY ON ANIMAL STUDY WHERE IS YOU SAID MALE ONLY SO GIVE AN EXAMPLE SO WE CAN PUT SOME FLESH ON THE IDEA. >> EXAMPLE FROM PRE-CLINICAL TO PHASE 1, JUST A DISEASE AREA. YOU WORK IN THESE SPACES. A LITTLE MORE GRANULARITY. >> BACK TO YOUR -- ON ANTI-BACTERIAL RESISTANCE. MAJORITY MALE ANIMALS AND WE'RE ENROLLING 50/50 FEMALE PATIENTS IN PHASE 1. >> SO STUDYING ANTI-BACTERIAL RESISTANCE IN MALE MICE. >> I'LL NOT PERSONALLY BUT THE PRE-CLINICAL STUDIES ARE LEADING TO THOSE IN THE FDA FOR THE IND SUBMISSION. IN MALES. >> IS THE RATIONALE THAT'S GIVEN FOR LIMITING THE STUDIES TO MALE MICE THE TRADITIONAL ONE THAT WE HEARD FROM SENATOR MCCULSKY EARLIER? DON'T WANT TO DEAL WITH ESTER PSYCH? >> NO, MOSTLY JUST THE BACKGROUND, STANDARD BACKGROUND, INBRED STRAINS DON'T WANT VARIATION IN THE BEGINNING WHEN LOOKING AT THE ACTUAL PROTEINS AND MECHANISMS. >> OKAY MAYBE I CAN GET LOUISE TO FOLLOW-UP ON THIS QUESTION. >> I CAN GIVE A CLINICAL EXAMPLE OF WOMEN AND MEN, THE BIGGEST EXAMPLE IS STROKE, THE ORIGINAL TRIALS FOR CAROTID ANDARECTOMIES IS BECAUSE THEY USED VA WHICH IS PREDOMINATE MALE SO THE INFORMATION WE GOT ON CAROTID ANDARECTOMY WAS FLAWED DATA BECAUSE WE DIDN'T INCLUDE WOMEN AND WE WITH NOW KNOW THAT WOMEN ACTUALLY IS A MUCH HIGHER THRESHOLD TO GIVE US CAROTID ENDARECTOMY BECAUSE THEY HAVE COMPLICATIONS. VESSELS ARE SMALLER, MORE THROMBOTIC SO THAT'S A CLINICAL EXAMPLE. >> WHEN YOU SAY THERE'S A HIGHER THRESHOLD >> TO DO THEM SO YOU HAVE TO BE SYMPTOMATIC, IT'S A RECOMMENDATION C IN A WOMAN FOR ASYMPTOMATIC VERSUS B OR A IN A MAN. BECAUSE TECHNICAL ISSUES. AND SOME -- AND IT TOOK TEN YEARS TO CATCH UP FROM THE DATA THAT WAS DUB PREDOMINANTLY IN MEN. >> TECHNICAL ISSUES BEING -- >> ARTERIES ARE SMALLER. SO HARDER TO CLAMP, HARDER TO BYPASS. THEY HAVE MORE PERIOPERATIVE COMPLICATIONS. WOMEN DO. SO THAT'S INDEPENDENT OF AGE. SO THERE IS DIFFERENT GUIDELINE, IN FACT THE AMERICAN HEART ASSOCIATION LAST YEAR CAME OUT WITH THE FIRST SET SPECIFIC -- SEX SPECIFIC GUIDELINES FOR PREVENTION OF STROKE. FOR EXAMPLE, WOMEN HAVE DIFFERENT RISK FACTORS. PREGNANCY BEING THE PRIME ONE AND PREECLAMPSIA AS JANINE MENTIONED INCREASES RISK OF DEVELOPING HYPERTENSION FOUR FOLD LATER IN LIFE SO SHOULD THOSE WOMEN BE SCREENED MORE OFTEN, TWO FOLD INCREASE IN RICKS. WHAT'S REALLY INTERESTING IS IF YOU FOLLOW OVER TIME THERE'S EPIGENETIC CHANGE IN THE FETUS BECAUSE THEY FOLLOWED ASIAN PATIENTS OUT BORN OF PREECLAMPTIC MOTHER AND THEY HAVE A TWO TO THREE FOLD RISK OF STROKE WHEN THEY'RE 50. SOMETHING THAT HAPPENS IN UTERO EFFECT AFFECTS MOTHER AND CHILD. BUT BACK TO QUICK EXAMPLE OF COMPARABILITY SO PRIME EXAMPLE IS WOMEN'S HEALTH INITIATIVE. WE THOUGHT ESTROGEN WAS GOOD, THAT'S WHY WOMEN DIDN'T HAVE STROKES UNTIL LATE BECAUSE WE WERE PROTECTED DUE TO ESTROGEN. IF YOU HAVE ESTROGEN YOU HAVE A SMALLER STROKE EXPERIMENTALLY SO IT MADE SENSE SO WE SHOULD GIVE HORMONES TO WOMEN AND REDUCE STROKE RISK AND PARADOXICALLY INCREASED STROKE RISK. WHEN YOU GO BACK AND DO THE STUDY MS. THE LAB, SO THE AVERAGE AGE WAS IN THE EARLY '60s FOR WOMEN EBB ROLLED SO THEY WERE WITHOUT HORMONES FOR TEN YEARS AND THEY WERE GIVEN HIGH DOSE HORMONE, THEY WERE A LITTLE PRO-INFLAMMATORY AND HIGHER THROMBOTIC RISK. BACK TO THE LAB PHILLIP WISE AND OURSELVES DID AND MODEL IT APPROPRIATELY USING A 20 MONTH OLD FEMALE THAT WAS WELL PAST MEN PAUSE AND TOOK MALLS AND GAVE ESTROGEN TWO WEEKS BEFORE INDUCED STROKE OR GAVE STARTING AT 15 MONTHS SO THEY WERE NEVER WITHOUT ESTROGEN, THE ANIMALS THAT WERE CONSTANTLY HELD WITH ESTROGEN ON BOARD, EXOGENOUS ESTROGEN HAD SMALL STROKES. THE ONES THAT HAVE THE ESTROGEN TWO WEEKS BEFORE INDUCED STROKE HAD MUCH BIGGER STROKES. SO YOU CAN ACTUALLY MODEL WHAT WE SAW IN THE WHI SO IT'S NOT PRE-CLINICAL MODELS WERE PARTICULARLY FLAWED, IT'S THE WAY WE DESIGN THE STUDY. I WAS ABOUT TO GIVE ON ANIMAL MODELING, IT'S REASSURING TO KNOW IF WE DO APPROPRIATELY MODEL IT SOME DISEASES IN NEUROLOGY ARE HARDER FOR EXAMPLE MICE DON'T DEVELOP AMYLOID. SO YOU HAVE TO DO GENETIC FINAGLING TO GET THEM TO DEVELOP AMYLOID BUT STILL A GOOD MODEL AND OUR PRE-CLINICAL MODELS ARE USEFUL BOTH IN MALE AND FEMALES, WE HAVE TO FACTOR IN THINGS LIKE AGE. >> LOUISE, YOU LET IT SLIP THERE, THAT AT ONE POINT YOU WERE ABOUT TO GIVE US ON THE ANIMAL MODELS. AND IT SOUNDS LIKE THAT WAS -- I THINK FOR MANY OF US WE CHOOSE OUR CAREERS AND OUR PATHS THERE ARE LITTLE JUNCTURES WHERE YOU'RE SORT OF DECIDING IS THIS GO, NO GO, SO TELL US MORE ABOUT THAT WHAT HAPPENED AROUND THAT SPACE IN TIME? >> I THINK FOR ME AS A CLINICIAN AS WELL AS Ph.D. NEUROSCIENTIST TRAINED, I WAS HESITANT TO ABANDON BASIC SCIENCE BUT TRYING TO GET SOMETHING TO A PATIENT TO MAKE THEM BETTER, YOU'RE LOOKING AT THESE MODELS AND YEAH, IT'S FRUSTRATING AND YOU HEAR IT AGAIN AND AGAIN, WHY ARE WE SENDING THIS MONEY, WE STILL DON'T HAVE ONE EFFECTIVE DRUG FOR STROKE BECAUSE STROKE IS A TOUGH DISEASE TO TREAT AND WE'RE GETTING THERE. I THINK SEEING HOW IMPORTANT THESE WERE BOTH EVEN AT THE CELLULAR LEVEL, CONVINCE ME WE HAVE TO DO PRE-CLINICAL MODELS WE HAVE TO DO CELLULAR MODELS BECAUSE AUNT EDNA WILL ALWAYS HAVE TROUBLE GETTING TO WALGREENS TO PICK UP HER PRESCRIPTION. I NEED A LOT OF AUNT EDNAS TO BALANCE THE VARIANTS IN HUMAN POPULATION. WHEN I HAVE A BLACK C-57 MOUSE THEY'RE THE SAME AND IF YOU SEE A DIFFERENCE, IT WAS BECAUSE OF SOMETHING YOU'RE DOING. IN BIG POPULATIONS IT DEPENDS ON OTHER FACTORS, DEPRESSION, SOCIAL FACTORS, COMPLIANCE, AND WE DO MANAGE TO GET RID OF A LOT OF THOSE IN THE PRE-CLINICAL MODELS WHICH I THINK IS VERY VALUABLE. AND WHEN YOU SEE A BIOLOGICAL FACT, I DON'T WANT TO GO ON TOO LONG, BUT WE FOUND EVEN WITH SOCIAL ISOLATION, IF YOU TAKE TWO ANIMALS SOCIAL ISOLATION IS A BIG RISK FOR STROKE AS IS HYPERTENSION. AS BIG A RISK FOR RECOVERY FROM STROKE,INSTANT STROKE AND FATAL STROKE AS IS OBESITY DIABETES AND HYPERTENSION BUT EVERYBODY SAYS THEY'RE ISOLATED THEY SMOKE AND DRINK MORE BUT TAKE TWO ANIMALS AND SEPARATE THEM A WEEK BEFORE YOU INDUCE A STROKE, THEIR STROKE IS 50% BIGGER THAT'S NOT COMPLIANCE, THAT'S NOT FROM SMOKING, AND IT'S NOT EVEN GENETIC BECAUSE THEY'RE THE SAME GENETIC STRAIN. IF YOU WAIT UNTIL THE STROKE IS MATURE, AND YOU GIVE THE EXACT SAME STROKE YOU LEAVE THEM TOGETHER AND THEN SEPARATE THEM, THE ISOLATED ONE DIES. 30 DAYS LATER, 60 DAYS LATER STILL DYING SO THAT'S VERY FUNDAMENTAL AND VERY BIOLOGICAL THAT I CAN'T REALLY STUDY THAT WELL IN HUMANS. BECAUSE OF VARIANTS. NOW I CAN ISOLATE THIS, FIGURE WHAT IT IS, LOOK AT CYTOKINES AN THESE OTHER THINGS AND BE ABLE TO ISOLATE THE AFFECT IN AN ANIMAL MODEL SO I THINK ANIMAL MODELS ARE INCREDIBLY USEFUL, I'M NEVER GIVING THEM UP NOW. >> THAT'S CLEAR. WE'LL KEEP -- TRY TO KEEP OUR MICE SAFE FROM THE CELL. YEAH. YEAH. BARBARA, I WILL TURN TO YOU A LITTLE BIT. THIS MORNING WE WERE HEARING FROM CATHY HUDSON ABOUT PRECISION MEDICINE INITIATIVE. ARGUABLY THE PRECISION MEDICINE INITIATIVE HAS GROWN OUT OF HUMAN GENETICS AND GENOMICS REVOLUTION, IT IS CERTAINLY GROUNDED THERE. SO BARBARA, THINKING ABOUT -- AND YOU'RE IMMERSED MANY NOW THE WORLD OF THE HUMAN GENOME HUMAN GENETIC ANALYSIS, YOU'RE THE ONLY ONE HERE WHO FOCUSED SQUARELY AND EXCLUSIVELY ON HUMAN EYE BIOLOGY, SO HOW ARE WE DOING IN THE WORLD OF GENOME WIDE ASSOCIATION STUDIES AND SUCH WITH RESPECT TO COGNIZANCE OF? DESCRIPTION OF SEX DIFFERENCES? >> SO THAT'S A VERY, VERY BIG QUESTION >> TAKE ANY PART YOU LIKE. >> THERE'S LOTS OF PARTS TO THAT. A LITTLE BACKGROUND T HUMAN GENOME PROJECT OBVIOUSLY FACILITATED STUDYING GENETICS OF COMPLEX DISEASES. AND THE INTERNATIONAL HAT MAP, WAS VERY FORWARD THINKING IN A WAY THAT EVENTUALLY THERE WOULD BE THE CHANCE TO CONSIDER CONTEXT SPECIFICITY OF DISEASE IN POPULATIONS OF DIFFERENT ANCESTRY. IS THE GROUND WORK WAS LAID FOR THINKING ABOUT THAT. GENOME WIDE ASSOCIATION STUDIES PROGRESSED TO START WITH ALMOST NONE OF THE STUDIES INCLUDED THE SEX CHROMOSOMES. THIS IS NOW CHANGING A LITTLE BIT. ALMOST NONE OF THE STUDIES -- >> LET ME CUT IN. WHEN YOU SAY ALMOST NONE OF THE STUDIES, COULD YOU BE MORE SPECIFIC? >> SURE. THERE ARE GENOME WIDE ASSOCIATION STUDIES FOR MANY, MANY, MANY COMPLEX TRAITS NOW. GO BACK THROUGH THE LITERATURE AND LOOK AT THE TRAITS MANY CARDIO VASCURASH TRAITS AND DISEASES AND HYPERTENSION AND BLOOD LIPID TRAITS, SO ON, EVEN DISEASES KNOWN BIG SEX DIFFERENCES THE AUTOIMMUNE DISEASES NEUROPSYCHIATRIC DISEASES HAVE NOT INCLUDED SEX CHROMOSOME GENOTYPES. I WOULD SAY IN THE LAST FEW YEARS, THIS IS CHANGING. >> THESE GWAS STUDIES HAVE NOT INCLUDED THE X, DOES NOT INCLUDE THE Y -- >> DESPITE HAVING BALANCED DESIGNS IN TERMS OF MALE, FEMALE. >> THIS SHOULD BE THIS MORNING ONE OF THESE POINTS WELL, JANINE, YOU SAID ONE REACTION YOU GET FROM MANY PEOPLE IS I CAN'T BELIEVE THAT. SURELY THIS CAN'T BE TRUE. THIS IS A SURELY THIS CAN'T BE TRUE MOMENT. TELL US WHY IT IS. >> I HONESTLY THINK IT'S BECAUSE PEOPLE COMPLICATED THE ANALYSIS. >> HAVEN'T WE HEARD THAT BEFORE? >> DOSAGE DIFFERENCES AND ALSO STATISTICAL METHODS WEREN'T THERE YET. TO DO ON LARGE SCALE STATISTICAL GENOMICS GENETICS AND THINKING ABOUT DOSAGE DIFFERENCES AND HOW TO EVALUATE THAT. NONETHELESS, THE DATA IS THERE. THE DATA THERE. YOU CAN DOWNLOAD GENOME WIDE ASSOCIATION STUDY DATA SETS, FROM DB GAP AND IF YOU'RE INTERESTED IN SEX CHROMOSOMES YOU CAN GET THAT INFORMATION BUT IT MAY NOT FOR THE MOST PART WAS NOT PART OF THE PRIMARY LITERATURE. FOLLOW-UP ON THAT, IF YOU THINK ABOUT SAY MOST OF THE PUBLISHED GENOME WIDE ASSOCIATION STUDIES HAVE LOOKED ONLY AT AUTOSOMAL GENOTYPES ONLY IN THE LAST I WOULD SAY THREE OR SO YEARS HAVE THERE BEEN ANY DISCUSSION OF DIFFERENCES IN THE GENETIC BASIS OF THESE COMPLEX DISEASES. BY SEX. ANECDOTALLY SPEAKING TO OUR COLLEAGUES DID YOU LOOK FOR SEX DIFFERENCE? THE ANSWER ALMOST CERTAINLY IS YES. WAS IT IN THEBLYCATIONS? NO. MANY OF THE STUDIES ARE NOT POWERED FOR SEX STRATIFIED ANALYSES SO WE TALKED ABOUT THIS, BUT IT'S NOT MENTIONED IN THE STUDIES. 90 SOMETHING PERCENT I WOULD SAY THAT THEY LOOKED AND THERE WAS NO SEX INTERACTION. THE DATA IS THERE TO LOOK AT. AND SO IN OUR LAB WE STARTED DOING SOME OF THESE ANALYSES GOING BACK TO GWAS STUDIES PUBLISHED AND DOING THE SEX STRATIFIED ANALYSES. THEY'RE UNDERPOWERED BUT THERE'S INTERESTING THINGS THERE B THROUGH META ANALYSES, WE HAVE AVENUES TO PURSUE. >> VERY INTERESTING. SO -- >> ONE LAST THING TO THAT TOO, THERE'S A TON OF GENE EXPRESSION DATA OUT THERE AND MY LAB AND MANY OTHERS STUDIED GENETICS OF GENE EXPRESSION SO THERE'S TONS OF EQTL OR EXPRESSION QUANTITATIVE TRAIT ROW SIGH OUT THERE IN DATABASES AND YOU CAN LOOK UP TO SEE WHAT A SPECIFIC POLYMORPHISM DO, AGAIN ALMOST NONE HAVE LOOKED AT SEX CHROMOSOME GENE EXPRESSION IN TERMS OF THE REGULATION OF SEX CHROMOSOME GENE EXPRESSION AND THE GTEX CONSORTIUM ITSELF, ONLY RESENTENCELY RELEASED TO THE CONSORTIA MEMBERS THE SEX CHROMOSOME GENETIC DATA SO EVEN WITHIN OUR CONSOR YUM WE HAVE REALLY GOTTEN UP TO SPEED WITH THAT. >> ART. >> JUST A SHORT POINT. THERE ARE OTHER THINGS GWAS STUDIES WON'T SHOW ABOUT THE SEX CHROMOSOMES. FOR EXAMPLE IF YOU WANT TO SAY WHAT IS EFFECT OF Y GENES ON A TRAIT, THE EFFECT OF THE Y GENE IS ALWAYS CONFOUNDED WITH HAVING TESTES IN THE HUMAN POPULATION SO IT'S ALMOST IMPOSSIBLE TO SEPARATE DIRECT Y GENE EFFECTS IN THE LIVER, THE BRAIN OR SOMETHING LIKE THAT. DOSAGE EFFECTS, THAT IS HAVING TWO COPIES OF AN X GENE SEARCH AND SEIZURE ONE COPY MAY NOT COME OUT OF A GWAS STUDY BECAUSE LOOKING AT GENETIC VARIATION, WHEREAS IN THE DOSAGE EFFECT IS NOT AN EFFECTIVE VARIATION BUT JUST DOSAGE. SEX CHROMOSOMES ARE ARE DOUBLY DISADVANTAGED HERE, NOT ONLY HAVING HAD THE STATISTICAL METHODS TO DEAL WITH THEM BUT EFFECTS DON'T COME OUT OF THOSE STUDIES. >> LET ME FOLLOW-UP SO YOU HAVE PIONEERED TOGETHER WITH PAUL AND COLLEAGUES THE FOUR CORE GENOTYPES MODEL WHICH YOU ARE ALLUDING TO, SOME THINGS CAN BE DISENTANGLED IN THE MOUSE. SO HOW WOULD YOU RATIONALE OR MIND SET OF FOUR CORE GENOTYPES MOUSE STUDIES HOW WOULD YOU CARRY THOSE IN TO THE WORLD OF HUMAN BIOLOGY? >> IF YOU GET SOME GOOD IDEAS STUDYING THE MICE FOR EXAMPLE WHICH X AND Y GENES ARE ACTING WHERE, YOU CAN GO TO HUMANS AND TRY TO GET EVIDENCE FOR WHETHER THOSE SAME GENES THAT MIGHT BE ASSOCIATED WITH THE DISEASE. SO IF YOU HAVE A Y GENE EXPRESSED IN THE LIVER AND YOU THINK THE Y GENE IS DOING SOMETHING, LOOK AT CORRELATIONS BETWEEN EXPRESSION OF Y GENE, IF YOU CAN GET THAT, OR GENETIC VARIATION IN Y CHROMOSOME ACROSS MEN ONLY COMPARED TO WOMEN CONFOUNDED WITH HORMONE LEVELS AND MANY THINGS INFLUENCE BY SEX CHROMOSOME GENES ARE INFLUENCED BY HORMONES, NOT CLEAN SEPARATE EFFECTS OFTEN SO IN ANY CASE, THERE ARE METHODS TO BE APPLIED IN HUMANS THAT I'M NOT AN EXPERT IN BUT TO LOOK FOR ASSOCIATIONS OF THOSE SPECIFIC GENES IN A FOCUSED WELL POWERED INVESTIGATION ONCE YOU HAVE THE GENE SO TIME OF COMPARISON REALLY IS ONCE YOU KNOW WHICH GENES ARE DOING WHAT IN THE MOUSE. >> ART YOU ALLUDED IN OPENING REMARKS TO THE ROLE OF THE BIRDS YOU WERE STUDYING AND THERE WERE SEX DIFFERENCES IN BRINGING YOU IN TO THIS SPACE. I WOULD BE INTERESTED TO HEAR IF YOU WOULD LIKE TO ELABORATE UPON THAT OR ESPECIALLY FROM ANY PANELISTS ABOUT WHAT WAS THE MOMENT IN THE CAREER WHEN YOU STARTED THINKING ABOUT STUDYING SEX DIFFERENCES? DID IT POP INTO YOUR OKAY HEAD, DID A MENTOR SUGGEST IT? HOW DID YOU GET INTO THE SEX DIFFERENCES SPACE? I DON'T KNOW IF YOU NEED A MINUTE TO THINK ABOUT THAT OR IF IT JUMPS TO MIND FOR ANYBODY. IF IT JUMPS TO MIND? OKAY I'M SEEING SOME YESES SO LOUISE, TAKE IT AWAY. >> TELL YOU THIS STORY, WHEN I WAS AT HOPKINS, I WAS A RESIDENT THERE AND DURING MY RESIDENCY -- >> YOU WERE A RESIDENT IN NEUROLOGY. >> RESIDENT IN NEUROLOGY AT HOPKINS AIN'T STARTED WORK IN A LAB DOING BASIC SIGNS BEFORE THAT AND I WANTED TO GO BACK O THE LAB AND I LIKED THE LAB SO DURING MY FINAL YEAR RESIDENCY AND STEWARD FELLOWSHIP, I'M GOING TO LAB SO I WENT TO THIS LAB AND I LEARNED HOW TO DO STROKE MODELING AND I LEARNED HOW TO DO STROKE AND MICE AND IT WAS REALLY EXCITING AND I WAS LOOKING AT ESTROGEN EFFECTS BECAUSE I WAS INTERESTED IN WOMEN'S HEALTH AND I DID, I DON'T KNOW, THOUSANDS IN MY LIFE AND I DID -- >> WE HAVE HEARD -- >> LIFE SAVING. AND I WAS LOOKING AT THIS PARTICULAR MOUSE STRAIN NEURONAL NITRIC OXIDE SYNTHASE KNOCK OUT MOUSE WHICH IS SHOWN IN A SCIENCE PAPER TO BE PROTECT AD AGAINST STROKE ISCHEMIC INJURY AND SO I START DODDING FEMALES AND LOOKING AT ESTROGEN AND IT DIDN'T WORK, IT DROVE ME BATTY. >> ESTROGEN, NO ESTROGEN, WHATEVER, THESE MICE WERE NOT PROTECTED, THE FEMALE MICE, I WAS TRYING TO SEE HOW ESTROGEN INTERFERED WITH NL SIGNALING. SO I KEPT GOING TO THE MENTOR, THIS DOESN'T WORK THESE MICE ARE NOT PROTECTED, I DON'T KNOW WHERE SO I DID THE MALES, TO SAY WELL, IT MUST BE TERRIBLE IN STROKE, SO MALES ARE PROTECTED, I DID HUNDREDS OF -- AND I DID ESTROGEN AND I COULDN'T MAKE IT WORK. AND I WAS LIKE -- SO MENTORS JUST STOP, THE PROJECT IS GOING NOWHERE, I NEED TO GET YOU A FELLOWSHIP, STOP LOOKING AT THESE MICE AND OF COURSE THE THICK THAT'S DOWNSTREAM FROM NO SIGNALING AND PROBING SAID NITRATE IS PARP, OH NO, I GET THE PARP KNOCKOUT MICE AND THE SAME THING NEXT YEAR SO NEXT YEAR I DID HUNDREDS OF PARP, STOP, STOP, STOP, THEN IT WAS AFTER PROBABLY TWO AND A HALF YEARS I REALIZED THAT IT WAS NOT ME, I WAS NOT FLAWED IN THESE, IT WAS NOT THE MOUSE, IT WAS THAT THERE WAS A SEX DIFFERENCE. AFTER THAT I WAS HOOKED. I LIKE HITTING MY HEAD AGAINST A WALL I GUESS AND THAT WAS THAT'S WHEN I WAS BACK TO CELL MODEL. THAT WAS MY MOMENT. >> SO LOUISE SAYS IF ALL ELSE FAILS CONSIDER A SEX DIFFERENCE. >> EXACTLY. MUST BE. >> AS A LAST RESORT. TAKE IT AWAY THERE. >> I HAD A SIMILAR FRUSTRATING MOMENT MALE AND FEMALE MICE, YES DIDN'T KNOW -- CALCIUM WE KNEW THAT MUCH BUT DIDN'T KNOW WHETHER THE SODIUM CALCIUM EXCHANGE, IT WAS REVERSIBLE. CALCIUM LOWER SEX RECEIVING INJURY OR IT COULD INCREASE AND BE THE ROOT CAUSE OF THE CALCIUM DOING DAMAGE SO IT DOESN'T -- SODIUM CALCIUM EXCHANGE IN MICE, IT'S CONTRACTILITY TO THESE MICE PROBABLY ABOUT 60% MORE THAN NORMAL EXPOSE MISDEMEANOR THE MALE THAN THE FEMALE EXPRESSION OF SODIUM CALCIUM EXCHANGE SAME IN THE MALES AND FEMALES. ISCHEMIA, I DID THE REPERFUSION AND LOOK AD RECOVERY IN THE FEMALES LOOKED LIKE (INAUDIBLE). >> HADN'T DONE ANYTHING. >> THE MALES WERE DAMAGED, FUNCTION WAS LOW, THE ENZYMES WERE LOW. FEMALES NO EFFECT. WILD TYPE FEMALE, WILD TYPE MALES. RECOVERY. CHECK WITH TEMPERATURE, DO IT AGAIN, DO IT AGAIN AND REALIZING THAT THE REPRODUCIBLE RESULTS, REVERSE LAB PROTECTION BUT NOT A LOT SO MODELS ARE THE OPPOSITE WE HAVE FEMALE PROTECTION BUT NOT IN THE MALE SO THINKING BACK EVERYTHING THEY SENT ME WAS FEMALE WE WOULDN'T FOLLOW THE PATH OF SODIUM CALCIUM EXCHANGE LEADS TO INJURY, WHAT'S THOSE MECHANISMS OF INJURY. LOOKING DOWNSTREAM AT ESTROGEN RECEPTOR, BETA KNOCKOUT MICE, NIGH THROWS OXYGEN SYNTHASE, LEADING TO DEVELOPMENT OF PROTECTION MODEL IN A SIMILAR TIME, BECAUSE LED TO SEX DIFFERENCES IN THESE MICE, WE LOOK AT HEART FAILURE BECAUSE OVEREXPRESSING BETA ADRENERGIC RECEPTORS TO INCREASE CONTRACTILITY AND MEASURING HEART FAILURE. THERE WAS A BETA RECEPTOR EXPRESS AND A KINASE SO THE KINASE PHOSPHORYLATES THE RECEPTOR SO IS OVEREXPRESS AND REACTIVATED AND OTHER THINGS AS WELL SO IN THE MALES WE FOUND THAT RECEPTOR EXPRESS HAD DAMAGE IN WILD TYPE BUT THE KINASE DID NOT SO BOTH INCREASE CONTRACTILITY BUT ONE LEADS TO MORE DAMAGE, ONE DOESN'T AND THE FEMALES ARE PROTECTED. SO IF WE GOT FEMALE WE CONCLUDES THOSE ARE SAFE EFFECTIVE POTENTIAL TREATMENT INCREASING CONTRACTILITY WITH NO EFFECT ON ISCHEMIC INJURY BUT THAT WOULD HAVE BEEN INCORRECT. SO WE'RE AGAIN LOOKING AT BOTH SEXES AND (INAUDIBLE). >> HEATHER, SOUNDS LIKE THE PASSION YOU DELIVER THIS STORY SEEMS INVESTED IN THIS RESEARCH. WHAT STAGE IN YOUR CAREER WERE YOU WHEN DOING -- SORT OF REALIZED THIS? >> POST DOC. >> POST DOC. AND HOW LOUISE TOLD US ABOUT THE RECEPTION THAT SHE RECEIVED FROM HER PI. RECEPTION. HEATHER WHAT IS THE RECEPTION, YOUR COLLEAGUES AND THOSE AROUND YOU RECEPTIVE TO FINDING SEX DIFFERENCE WHERE YOU PERHAPS HADN'T BEEN ANTICIPATE SOMETHING >> SIMILAR QUESTION WHAT DO YOU DO, IT WAS VERY, VERY CLEAR. >> I DON'T KNOW IF EITHER PANELIST ON THE END WANTS SPEAK TO THE QUESTION OF WHAT WAS THE TRIGGER POINT FOR YOU PERSONALLY THINKING SEX DIFFERENCES, BARBARA. >> MINE WAS A MEANDERING PATH TO THIS POINT. I WAS TRAINED AS POPULATION GENETICIST SO I DID ANALYSIS OF DNA SEQUENCE AND GOT INTERESTED TRYING TO UNDERSTAND WHAT'S A FUNCTION OF VARIANTS WE WERE LOOKING AT SO WE SAY THIS PATTERN IS CONSISTENT WITH EITHER NATURAL SELECTION OR IS CONSISTENT WITH DE DEMOGRAPHY SO THAT GOT ME INTENTIONED IN FUNCTIONAL GENOMICS. WE START DODDING FUNCTIONAL HUMAN GENOMICS WITH HAT MAP CELL LINES GENE EXPRESSION HAT MAP CELL LINES LYMPHOBLASTOID CELL LINES DERIVED FROM PEOPLE, FROM FOUR DIFFERENT ANCESTRY GROUPS, THIS WAS PART OF A VERY LARGE INTERNATIONAL COLLABORATION. THEY GENOTYPES ALL CELL LINES, AND SO COULD MEASURE GENETIC CORRELATIONS BETWEEN PARTICULAR SNPS, MAKING A HAPLO TYPE MAP. SO HAP MAP STANDS FOR HAPLOTYPE MAP SO MAKING THOSE TO DETERMINE GENOME WIDE ASSOCIATION STUDIES BY UNDERSTANDING HOW THE GENETIC VARIATION IS IN BLOCKS ALONG THE GENOME. WITH THAT RESOURCE THEY CREATED CELL LINES TO MEASURE CELLULAR PHENOTYPES RENEWABLE RESOURCE, WE CAN MEASURE GENE EXPRESSION CELL LINES AND TRY TO IDENTIFY ENGINE TICK POLYMORPHISMS THAT CONTRIBUTED TO EXPRESSION LEVEL DIFFERENCES. WE HAVE DIFFERENT AN ZESTTRY GROUPS DO THESE DIFFER BETWEEN ANCESTRY GROUPS SO THERE'S A LOT OF DATA OUT THERE ABOUT DIFFERENCES BETWEEN AN ACCESSORY GROUPS, WHERE GENETICS IS POPULATIONS ARE DIFFERENT BUT ALSO SO ARE MANY THINGS ABOUT POPULATIONS. OF HUMAN INDIVIDUALS. PEOPLE START TO COMPARE TO DIFFERENT TISSUE AND THE SAME POLYMORPHISMS HAVE SAME EFFECT IN DIFFERENT TISSUES. WE DID SOME OF THAT WORK BUT FIRST IT WAS LIKE PEOPLE HAVE LYMPHOBLASTOID CELL LINE RESULTS AND SOME THE DID ADIPOSE TISSUE. THERE WERE DIFFERENCES BUT GENETICS WERE DIFFERENT, TISSUE DIFFERENT, ANALYSIS DIFFERENT, SO ON. ALL THAT BOTTLENECKED TO THE PROJECT, GENOTYPE TISSUE EXPRESSION PROJECT. SO THAT ALLOWED YOU TO LOOK AT THE CONTEXT OF ACROSS TISSUES. WITH WE HAVE ALSO LOOKED AT PRIMARY IMMUNE CELLS AS WELL AS STIMULATED IMMUNE CELLS ASKING ARE CONTEXT SPECIFICITY OF PARTICULAR GENETIC VARIANTS THERE BUT THEN IT'S VERY OBVIOUS TO ME, NEXT QUESTION ABOUT SEX DIFFERENCES, AND THINK ABOUT CELLULAR ENVIRONMENT IN SOME WAY OR ANOTHER OR JUST AN ENVIRONMENT I CAME FROM POPULATION GENETICS. MY Ph.D. WAS PLANT POPULATION GENETICS AND GENE ENVIRONMENT INTERACTIONS ARE VERY COMMON IN PLANTS. SO TO ME THINKING ABOUT THIS GENOTYPE ENVIRONMENT INTERACTION IN HUMAN CELLS IS VERY OBVIOUS QUESTION CHALLENGING TO DO BUT SEX IS ONE OF THOSE CELLULAR ENVIRONMENT KINDS OF QUESTIONS. >> FANTASTIC. I THINK ALL OF SCIENCE ACTUALLY HAPPENS IS A SERIES OF INDIVIDUAL ACCIDENTS. EACH OF US, IN THIS ROOM IS HERE FOR -- AS A RESULT OF SERIES OF LITTLE HISTORICAL ACCIDENTS. SO SHALL IT EVER BE I SUSPECT. ONE MORE QUESTION. >> YOU HAVE PLENTY OF TIME >> SO THE QUESTION I WOULD LIKE TO THROW OUT TO THE GROUP, SORT OF CIRCLING BACK TO THINGS WE TALKED ABOUT MODEL SYSTEMS AND SUCH, I'M GOING TO GO OUT ON A LIMB HERE, I DON'T KNOW WHAT I'M TALKING ABOUT BUT AND I HAVE NEVER DONE THAT BEFORE. SO YOU HAVE TO DO AT SOME POINT IN LIFE TODAY THIS IS THE MOMENT. TAKING THE EVENTS OF THE DAY SEEMS TO ME WE LOOK ON THE ONE HAND AT STUDIES TRIALS IN HUMANS. WE LOOK ON THE OTHER SIDE AT THE BASIC BIOLOGY, MUCH DUB IN MODEL SYSTEMS MICE AND SUCH. I REALIZE THE PANEL IS CONVERTED OF THOSE WHO ARE OBSESSED WITH STUDYING THINGS IN ANIMALS OR IN CELLS IN BOTH SEXES. BUT STRIKES ME THAT MORE BROADLY, THERE MIGHT BE TRUTH TO THE GENERALIZATIONS WHILE WE'RE AT THE POINT WHERE MORE THAN 50% INDIVIDUALS ENROLLED IN CLINICAL TRIALS ARE WOMEN, IT MAYBE THE CASE BASIC SCIENCE IS THE LAG GUARD HERE. AND IS -- DOES THIS RING TRUE TO YOU? I WOULD BE INTERESTED IN ANY COMMENTS THAT YOU MIGHT HAVE, STEEPED IN NEUROSCIENCE, MY SENSE IS WITH BASIC NEUROSCIENCE THE RESULT IS STUDYING THINGS IN MALES. IS THE GENERALIZATIONS OFFERING AN ACCURATE ONE AND OR DISAGREE WITH IT AND IF SO, WHERE DO WE GO FROM HERE? (OFF MIC) >> THE ANIMAL SEX IS REMOVED FROM YOUR WORK. >> WHEN YOU SAY CELL LINE. (OVERLAPPING SPEAKERS) >> YOU DON'T SEE THE ANIMAL, SOME OF THE CELL LINEIOUS GET A CELL LINE, YOU DON'T EVEN THINK SO MUCH ABOUT THE INTEGRATED BIOLOGY OF IT SO MAYBE THAT'S PART OF THE REASON WE FELL BEHIND THERE. I ALSO THINK IN CLINICAL TRIALS THOUGH WHEN YOU GET TO CLINICAL TRIALS ENROLLMENT, I STILL THINK PHASE # AND 2 AND DOSE FINDING, HAY EAR OVERREPRESENTED MANY THE MALES. PART OF THE REASON AND THE FDA CAN CERTAINLY SPEAK TO THIS, THIS HAS BEEN A BIG ISSUE FOR US AT THE OSSD LEVEL, MANY DRUGS GETTING TAKEN OFF THE MARKET, THE VAST MAJORITY ARE DUE TO SIDE EFFECTS THAT DIFFERENTIALLY EFFECT WOMEN. >> YOU'RE SAYING THE SAFETY TEST. >> THE EARLY PRE-CLINICAL TESTING. >> BEFORE EFFICACY TESTING. >> EXACTLY A LOT ARE OVERREPRESENTED IN MALES. >> IN HUMANS. >> MALE -- IN HUMANS EVEN. CLINICAL TRIALS AND FDA CAN SPEAK TO THESE NUMBERS. BUT THIS IS MY UNDERSTANDING FROM THEM WORKING WITH OSSD MANY THE EARLY PHASE WHERE YOU'RE KIND OF DOING SAFETY STUDIES AND SIDE EFFECT PROFILES, A LOT OF THOSE STILL FILL THE MAJORITY. >> EVEN IF BIG NIH FUNDEDDED TRIALS ARE SOMETHING LIKE (INAUDIBLE) YOU'RE SAYING THE EARLIER SAFETY TRIAL -- >> AND DOSAGE. AMBIENT CLASSIC EXAMPLE THAT CAME OUT LAST YEAR, WOMEN WERE MORE SENSITIVE TO SIDE EFFECTS AND FALLING AWE ASLEEP AND GETTING INTO CAR DEBITS, IT'S NOT JUST WEAK BASED METABOLISM, OTHER THINGS OCCUR. SO THERE'S STILL P P P A LITTLE BIT OF WORK TO BE DONE IN EARLY CLINICAL TRIALS, WE HAVE FARTHER TO GO ON THE ANIMAL SIDE BECAUSE NOBODY LIKES VARIANTS, PEOPLE DON'T LIKE VARIANTS. YOU DON'T WANT THE ERROR BAR SO IF YOU'RE CONCERNED SOMETHING ADDS VARIANTS I.E.s RACE, YOU'RE GOING TO TRY TO AVOID THOSE STUDIES. IT'S BEEN SHOWN, JILL HAS SHOWN IT AND OTHERS, THAT ESTERASE IS NOT THAT BIG A DEAL, IT DOESN'T EFFECT NEUROSCIENCE RESEARCH, IT EFFECTS MY RESEARCH IN STROKE, BUT AGAIN, IT SHOULDN'T BECAUSE 30-YEAR-OLD WOMEN DON'T GET STROKES UNLESS THEY'RE PERIPARTUM. WE SHOULD BE STUDYING 70-YEAR-OLD WOMEN, THAT'S WHAT I'M TRYING TO WRAP MY HEAD AROUND STUDYING SEX DIFFERENCES WE HAVE TO MODEL A LOT OF DISEASE AS LITTLE BIT BETTER. >> LOOKS LIKE YOU WANTED TO PICK UP. >> MINOR POINT, IT'S BEENING WE DOCUMENTED IN AREAS OF BIOMEDICAL SCIENCE MALES ARE STUDIED MORE FREQUENTLY THAN FEMALES. (INAUDIBLE) HAVE COUNTED THE NUMBER OF PAPERS AND THERE'S NO QUESTION. THERE'S ONE AREA WHICH I THINK IT MIGHT BE THE REVERSE. WHEN PEOPLE DISCOVER A SEX DIFFERENCE IN AN ANIMAL MODEL, IF YOU'RE A SEXUAL DIFFERENTIATIONIST OR WANT TO UNDERSTAND WHY THERE'S A DIFFERENCE, THERE'S EXPERIMENTS YOU CAN DO TO FIND OUT WHAT CAUSE IT IS SEX DIFFERENCE. FIRST YOU TAKE OUT THE GONADS. I'M WONDERING BECAUSE IT OCCURS TO ME THAT PEOPLE TEND TO TAKE OUT THE OVARIES MORE OFTEN THAN THEY DO THE TESTES. PEOPLE THINK SEX DIFFERENCE COMES FROM FEMALE SECRETING SOMETHING THAT MAKES HER DIFFERENT FROM THE MALE. WHEN IN FACT A LOT OF TIMES ALSO SECRETING SOMETHING THAT MAKES THE MALE DIFFERENT FROM THE FEMALE, WONDERING WHETHER THIS IS STILL -- SO PEOPLE DON'T STUDY THE MALES IS STILL ANTI-FEMALE BIAS LIKE THE MALES ARE OKAY, ARE THEY PEOPLE THAT DON'T WANT TO TAKE OUT THE TESTES? I DON'T KNOW WHY IT IS. BUT I ACTUALLY -- BE INTERESTING TO COUNT PAPERS, I SEE PEOPLE TAKING OUT OVARIES MORE OFTEN THAN TESTES. WHEN IN FACT THE TESTES SOMETIMES BOTH OVARIES AND TESTES MAKE THE TWO SEXES DIFFERENT FROM EACH OTHER. IT'S IMPORTANT, I'M A BIG FAN OF COMPLETE DESIGN SERIES IF YOU THINK TESTOSTERONE YOU GIVE TO IT MALE AND FEMALE, WHICH TELLS YOU IS IT MAKING THE MALE DIFFERENT THAN FEMALE? DOES MAKE THE FEMALE MALE LIKE A MALE OR DO THEY RESPOND DIFFERENTLY TO TESTOSTERONE? SAME WITH OVARIAN SECESSIONS, ESTROGEN TO BOTH SEXES, THAT'S SO MUCH WORK THAT PEOPLE ALMOST NEVER DO IT. JUST TO STUDY MAKE A COMPLETE WORK UP OF WHAT THE EFFECTS OF THE HORMONES ARE FOR STROKE LIKE, DOES ANYBODY STUDY THE EFFECTS OF TESTOSTERONE ON STROKE? >> THEY DO, IT DEPENDS ON AGE HOW THE ANIMAL RESPONDS, TESTOSTERONE IS AROMATIZED TO ESTROGEN SO IT BECOMES A COMPLEX DESIGN BECAUSE THEN YOU HAVE TO USE TESTOSTERONE AND NON-AROMATIZABLE ESTROGEN SO IT GETS COMPLICATED BUT TESTOSTERONE OVERALL IS THOUGHT DETERIOUS. THIS COMES OUT IN NEONATAL POPULATIONS WHERE BOYS DO A LITTLE WORSE THAN GIRLS. THAT IS TRUE IN PEDIATRIC POPULATIONS AND COORDINATED WITH TESTOSTERONE LEVELS SO WE'RE GETTING RID OF -- STUDYING NEONATES BUT THOSE HORMONES ARE STILL, AS YOU KNOW HAVING AFFECT. >> SO PRE-PUBERTAL MALE HAVE MORE? >> PREPUBERTAL MALES HAVE -- THERE'S A SEX EFFECT, THE SEX EFFECT IN HORMONE EFFECT SO IF YOU TAKE A NEONATE OR A YOUNG CHILD OR EARLY DELIVERY, 3 # 2 WEEKER THE FEMALE DOES BETTER THAN THE MALE, THEY HAVE LESS HYPOXIC ISCHEMIC INJURY FROM BEING PREMATURE. HOWEVER, IF YOU TAKE BOYS AND FOLLOW THEM IN NEONATAL PERIOD AND UP UNTIL PUBERTY, THE ONES THAT DO WORSE IF THEY HAVE A STROKE HAVE THE HIGHER TESTOSTERONE LEVELS. >> WE HAVE HEARD FROM OUR FOUR TERRIFIC PANELISTS ABOUT -- FROM SPEAKING FROM A RANGE OF PERSPECTIVES. FROM DEEPLY EMBEDDED IN A VARIETY OF VERTEBRATE MODEL SYSTEMS THROUGH MOVING BETWEEN RODENT AND HUMAN SYSTEMS ON TO THE LATEST ADVANCES IN HUMAN GENETIC ANALYSIS. WE HEARD FROM EACH PANELIST HOW THEY EACH INDIVIDUALLY GOT INTO THIS SPACE. AND WE NOW KNOW THAT THE PATH FORWARD IS COMPLETELY OBVIOUS AND STRAIGHT FORWARD. WHICH IS REALLY A WONDERFUL UPSHOT OF JUST ONE HOUR'S CONVERSATION WITH FOUR DISTINGUISHED LEADERS IN THIS SPACE. PERHAPS WE CAN MAYBE WE CAN TAKE -- TAKE A COUPLE OF QUESTIONS FROM -- I HAVE BEEN SUPPRESSING ALL SHOW OF HANDS. YOU GOT A QUESTION. >> WE FOUND INTERESTING SEX DIFFERENCES IN WILD TYPE AND KNOCKOUT MICE. HOW DO YOU SORT NO COHORT EFFECT, ALL PROGENY COME FROM ONE PAIR FROM JACKSON RANS BECAUSE IT'S THAT PARTICULAR FEMALE WAND MALE AND SOME OTHER PAIR GIVES A WHOLE DIFFERENT OUTCOME. >> LOOK AT MORE LITTERS. YOU CAN'T MAKE THIS REAL IMPORTANT BECAUSE THEY'RE BIG LITTER EFFECTS ESPECIALLY IN SOME STRAINS OR SOME SITUATION SO MAKE SURE YOU HAVE THE EFFECT LOOK AT MORE LITTERS. >> ALSO DEPENDS WHAT YOU SERE STUDYING SO WE FOUND DIFFERENCE IN TRAN GENIC MICE WE USED DIFFERENT TYPE TRANSGENIC MICE, AND WE ALSO TRIED TO MODEL THAT IN WILD TYPE MICE SO FOR A PARTICULAR EXAMPLE WE DID ADRENERGIC STIMULATION AND CALCIUM LOADING SO DEFINITELY NOT IN THAT CASE. >> YOU SHOULD DO THE HEAD BREEDING AND LOOK AT WILD TYPE LITTER MATES BUT I ALSO LIKE TO CONFIRM SOMETHING PHARMACO LOGICALLY IF YOU CAN. THAT HAS OFF TARGET EFFECTS, MIGHT NOT BE QUITE AS SPECIFIC YOU CAN'T DO A CELL TYPE SPECIFIC MYELOID KNOCK OUT BUT SEE SIMILAR EFFECTS IN CULTURE OR PHARMACOLOGICAL YOU FEEL MORE COMFORTABLE THAT IT'S NOT JUST SOMETHING IDIOSYNCRATIC AT THAT PARTICULAR MOUSE LINE. >> GREAT JOB. TO THE PANELISTS. FASCINATING CHALLENGE. I HAVEN'T HEARD ANYTHING, AND I DO KNOW THAT MICE COME MANY DIFFERENT COLORS. I THOUGHT THAT WAS GOOD. >> GOOD. >> AS WE TALKED ABOUT CAME OVER THIS MORNING. AND SO I GUESS I WOULD LIKE TO HAVE THE CONVERSATION EXPAND TO TALK THE INCREASINGLY DIVERSE POPULATION OF WOMEN OF COLOR. HOW WE'RE GOING TO ADDRESS THESE QUESTIONS AS WE MOVE FORWARD >> LOUISE, READY TO GO? >> OF COURSE. YOU MAY NOT LIKE THE ANSWER BUT IT'S REALLY INTERESTING POINT BECAUSE THERE ARE C-57 BLACK MOUSE, THERE'S ALBINO, THERE'S SV MICE WHICH ARE ARE BROWN. I THINK SOME OF THE STRAIN EFFECTS THAT WE SEE IN LAB MAYBE RELATED TO GENETICS IN RACIALLY DIVERSE POPULATIONS SO FOR EXAMPLE WE'RE TRYING NOW TO LOOK AT RESPONSE RATE TO THROMBOLYTICS. TURNS OUT THAT AFRICAN AMERICAN WOMEN OR WOMEN OF COLOR DON'T RESPOND AS WELL TO THROMBOLYTICS. WE DON'T KNOW WHY. IT PROBABLY TURNS OUT THAT IT WAS SOMETHING BIOLOGICAL, IN PLATELET ADHESION SO WE HAVE TO EXPLORE THESE IN HUMAN POPULATIONS, BECAUSE IT IS HARDER TO MODEL IN MOUSE BUT WHEN WE THINK MICE WE IGNORE A LOT OF STRAIN EFFECTS. IF IF YOU TAKE A C-57 MOUSE THEY HAVE A HUGE STROKE, TAKE A BALD C MICE WHICH IS A WHITE MOUSE, DIFFERENT BACKGROUND THEY'LL DIE FROM THE SAME STROKE C-57 WHICH 88 TO 90% SURVIVE FROM EVERY SINGLE WHITE MOUSE WILL DIE. THERE'S STRAIN EFFECTS AND YOU CAN FOLD THAT IN. I DON'T KNOW HOW THESE INTEGRATE WITH ACTUAL RACIAL MIXES. I DON'T KNOW BUT WE HAVE TO STUDY DISPARITIES FOR SURE. >> I WOULD PUSH ON THAT FURTHER. WE HAVE TO HAVE ARE THIS CONVERSATION. SO WE HAVE NICE AND WE HAVE SEEN DIFFERENCES IN MICE. THANK YOU VERY MUCH FOR SAYING THAT BECAUSE IT'S IMPORTANT. >> JUST LIKE JANINE'S WONDERFUL PAPER WHERE IT TALKS WE NEED TO ACTUALLY STUDY MALE AND FEMALE MICE. >> GO AHEAD. >> I'M A LITTLE WORRIED. YOU STARTED SOMETHING. I SEE A LOT OF RED LIGHTS AROUND THE TABLE HERE. I SAW OR CAPTAIN'S LIGHT ON. >> I THINK THERE ARE TOO MANY OTHER LIGHTS ON. THERE WE GO. >> MCCULLOUGH, CLARIFICATION ON 32 WEEK MALE VERSUS FEMALE, WE THOUGHT THE REASON THE MALES DID POORLY IS BECAUSE OF PULMONARY INSUFFICIENT MATURITY AND YOU'RE MAKING THE CLAIM IT'S REALLY NEURAL TOXICITY SO YOU WANT TO ONLY A NEW FIELD OF -- >> >> IT'S ABSOLUTELY BOTH. SO A LOT OF PULMONARY WE KNOW -- AND THE PROBLEM IS THE PULMONARY INSUFFICIENCY LEADS TO NEONATAL HYPOXIA, THAT'S WHAT CAN CAUSE THE BRAIN INJURY. THAT'S EARLY 6, 28 WEEKERS BUT LUNG MATURITY IS DIFFERENT IN MALES THAN FEMALES BUT CERTAINLY THERE'S RACIAL DIFFERENCES IN NEONATAL HYPOXIA. >> ABSOLUTELY. >> WHAT'S VERY INTERESTING IS WE CAN MODEL THAT IN THE LAB. MALE AND FEMALE, TAKE NEONATAL PUPS AND GIVE ISCHEMIC INJURY THE FEMALES DO BETTER. AND SO THERE'S DIFFERENCES IN THE BRAIN BUT A HUGE PULMONARY LITERATURE, RENAL LITERATURE AND I THINK IT JUST SHOW -- GOES TO SHOW SEX DIFFERENCES ARE IMPORTANT FOR LOTS OF DIFFERENT ORGAN SYSTEMS. BUT THE MALES DO MUCH WORSE ON A CEREBRAL BASIS AS WELCOME PAIRED TO A MATCHED FEMALE. >> THANK YOU VERY MUCH. DR. GREEN IN UTERO VISIT FEMALE OF COLOR DO BETTER THAN POOR MALES OF NON-COLOR. >> ALL RIGHT. SO WE'RE NOT GOING TO ALLOW ANY TENSION HERE BETWEEN OBGYN AND NEUROLOGY. THAT'S OFF COMPLETELY OFF LIMITS. >> JILL. >> THEY HAVE DEVELOPED NEW MICE THAT HAVE GREATER HETERO GENEITY OF GENOME BASED ON HUMAN TRAITS AND WE MIGHT LOOK AT DEVELOPING MORE -- DIFFERENT TYPES OF MICE APPROPRIATE FOR THESE MODELS LIKE SPONTANEOUSLY HYPERTENSIVE RAT MODEL. THOSE ARE USEFUL AND THEY HAVE A DIFFERENT GENETIC MAKE UP. THOSE POLYMORPHISMS OR GENES MAP BACK TO SOMETHING THAT WE ALSO SEE IN HUMAN, THAT'S WHERE WE HAVE TO INTEGRATE THE BIOLOGY. FIGURE OUT DIFFERENCE BY STRAIN WHAT IS CAUSING THAT STRAIN DIFFERENCE THAT MAKE AS STRAIN DINE DYE WHEN I GIVE A STROKE AND ONE JUST FINE TWO DAYS LATER AND IS THERE SOMETHING GENERAL TICKLY WE CAN CAPTURE SO GENETICS STUDIES ARE VALUABLE TRYING TO PUT CLINICAL DATA IN THE ANIMAL DATA. >> OKAY. >> QUESTION FOR SYMMETRY. I HEARD THREE STORIES HOW PEOPLE GO INTO SCIENCE BUT NOT FROM ART. I'M PARTICULARLY INTERESTED IN HEARING. THIS WAS AND IN YOUR BRAIN SEX DIFFERENCE, SO SPEAK ABOUT SEX DIFFERENCES IN THE BRAIN? QUITE INTERESTED IN YOUR PERSPECTIVE IN THAT. SO I FELL INTO THE FIELD OF SEX DIFFERENCES AS -- WHEN I WAS 29. >> I DISCOVERED HUGE DIFFERENCES IN THE BRAIN OF SONG BIRD. MALES SING A COURT SHIP SONG, FEMALES DONE. AT THE TIME I THINK THAT THAT THE TIME IT WAS NOT POPULAR TO TALK SEX DIFFERENCES MANY THE BRAIN. FEMINISTS DIDN'T WANT TO HEAR ABOUT IT BECAUSE OF INCREDIBLE STRUGGLE FOR EQUITY. >> WHAT YEAR? >> 1975, 40 YEARS AGO. >> DANGEROUS TIME. >> WHEREAS NOW THE APPROPRIATE MORE APPROPRIATE FEMINIST VIEWPOINT I SHARE IS MEN AND WOMEN ARE DIFFERENT SO TREAT THEM HE CAN TABLY YOU TREAT THEM EQUALLY WHEN APPROPRIATE, THAT'S WHAT WE'RE ALL HERE TODAY TO TALK ABOUT. SO I GOT -- THAT WAS INTERESTING DISCOVERY BUT IT WAS ACCIDENTAL TO RESONATE WITH SOME OF THE OTHER PANELISTS, I HAD TIME WHEN I SWITCH REDIRECT EXAMINATION BEING INTERESTED TO HORMONE TO SEX CHROMOSOMES WAS MORE DIFFICULT AND INTERESTING INTELLECTUAL SWITCH I KNEW SEX DIFFERENCES WERE CAUSED BY GOD INIAL HORMONES, IT TOOK TIME TO FIGHT OFF AND COME TO THE IDEA THAT MIGHT NOT BE TRUE SO WE SPENT TIME TRYING TO MAKE BIRDS ACT LIKE THE SERIES. OBEY THE LAWS WE KNEW WERE TRUE, THEY ARE TRUE BUT INCOMPLETE. AND THAT WAS A YOUNG PERSON, THE SAME THING, WE WOULD GO IN AND DO EXPERIMENT AND TAKE AWAY THE HORMONES IN THIS WAY AND TAKE AWAY HORMONES IN THAT WAY AND DO IT OVER AND OVER AND OVER. WHEN THE MOST INTERESTING THING WAS THAT THE BIRDS WERE NOT RESPONDING TO WHAT WE WERE DOING. BUT THAT OCCURRED TO ME WHEN I WAS IN EARLY 50s. >> QUESTION REGARDING ANALYSIS. PAPER DRAW CONCLUSION SAY THERE'S A SEX DIFFERENCE, I WOULD ASSUME THAT WE INCLUDE SEX AS ONE VARIABLE IN TO THEIR OWN ANALYSIS. SO A LOT OF TIME LOOKING AT THE PAPER THEY ANALYZE THE SEX DIFFERENTLY SO TO ANALYZE MALE VERSUS FEMALE SEPARATELY AND MAYBE THERE'S IN FACT MALE OR FEMALE USING SEX DIFFERENCES NEVERTHELESS COMBINE THE TWO SETS OF DATA THEY MIGHT NOT GET THE DIFFERENCE SO MY QUESTION FOR THE PANEL IS WHAT IS YOUR TAKE ON IN TERMS OF HOW TO ANALYZE THIS VARIABLE? >> WHAT TEASE QUESTION? >> WHAT'S YOUR THOUGHTS ON THAT, WHAT'S THE BEST WAY TO ANALYZE SEX AS VARIABLE? SHOULD WE CONSIDER THAT AS ONE VARIABLE INTO ONE BIG ANALYSIS OR WE SHOULD SEPARATELY ANALYZE MALE DATA AND FEMALE DATE AND IF THERE ARE DIFFERENCES WE MAKE A CONCLUSION SAYING THERE'S A SEX DIFFERENCE BUT IN REALITY THEY MIGHT NOT. >> AGREE THE COMMON ERROR PEOPLE FROM UCRA COME TO ME AND SAY HERE IS A DRUG EFFECT IN MALE AND IF I DO IN FEMALE IT'S NOT SIGNIFICANT. THAT DOESN'T SHOW A SEX DIFFERENCE BECAUSE THE LACK OF EFFECT IN FEMALE COULD BE UNDERPOWERED OR MORE VARIABILITY AND COULD BE A SAMPLE SIZE PROBLEM SO YOU HAVE TO PUT THEM TOGETHER IN USING -- IF DATA IS APPROPRIATE WITH SEX AS FACTOR, IN MY JOURNAL BIOLOGY SEX DIFFERENCES PEOPLE SUBMIT PAPERS , AND IF THEY DON'T COMPARE TWO IN A SINGLE STATISTICAL TEST WITH A P VALUE FOR EFFECTIVE SEX WE TELL THEM TO GO REDO THEIR STATISTICS. THAT'S IMPORTANT. PEOPLE THINK IF THEY GET EFFECT OF ONE SEX AND NOT THE OTHER, THAT SHOWS DIFFERENCE WHEN SOMETIMES IT'S NOT TRUE. >> BACK TO JENNIFER. >> THAT WAS FANTASTIC. THANKS TO THE PANELIST WHOSE PARTICIPATED. WE HEARD FROM ALL THE PANELISTS AND THEY HAVE GIVEN THEIR PERSPECTIVE AND BACKGROUND AND RESEARCH AND THE NEXT FIVE MINUTES OR SO I WOULD LIKE TO GIVE OUR MODERATOR A CHANCE TO BRIEFLY DISCUSS HIS RESEARCH PROGRAM OR PROVIDE SOME CLUES PROVIDE CONCLUDING REMARKS. >> THANK YOU. I THINK WITH THAT, -- SOMEHOW I'M TAKING THE MODERATOR PREROGATIVE, I'M GOING TO SHOW >> I HAVE COUPLE OF HUNDRED SLIDES SO ALLOWING PANELISTS TO ESCAPE SO THEY'RE NOT ACTUALLY -- [APPLAUSE] I JUST WANT TO SHARE A FEW NEW THINGS, I WOULD NOT CALL THIS (INAUDIBLE) (OFF MIC) >> GREAT. THANK YOU. SO JUST A FEW -- I WANT TO OFFER A FEW MUSINGS. SO ONE OF THE THINGS I FOUND MOST REMARKABLE ABOUT OUR PANELIST STORIES WERE THAT AT LEAST IN A COUPLE OF CASES THEY SORT OF FELL INTO THIS STUDY OF SEX DIFFERENCES KICKING AND SCREAMING. AT LEAST WITH THEIR PIs ORTHOS AROUND THEM, KICKING AND SCREAMING BECAUSE WE START WITH THE ORTHOS KICKING AND SCREAMING, BECAUSE OF ASSUMPTION WE'RE MONOMORPHIC, THAT WE DON'T HAVE TWO SEXES. P P P SO I OFFER THIS PIECE OF ART WORK TO ILLUSTRATE THAT WE HAVE KNOWN SINCE CHILD HOOD, MANY SPECIES EXIST IN TWO SECONDS SO HERE WE HAVE MARCHING ON TO -- YEAH, VALERIE YOU HAVE SEEN THIS, YOU HAVE SEEN THIS STORY BEFORE. WHAT CHILD DOESN'T KNOW HOW TO -- WHO DOESN'T LEARN TO IDENTIFY HERE WE HAVE -- MAYBE THE POINTER -- OOPS SORRY. WHAT CHILD DOESN'T LEARN TO IDENTIFY THAT THIS IS A MALE LION. HERE ARE THE PEACOCK, THERE ARE INTERESTING THINGS HERE SO THE EXISTENCE OF TWO SEXES, IS SOMETHING WE ABSORB AND IS EMBEDDED IN OUR OLDEST MOST REVERED STORIES. AND ACTUALLY BUT THERE'S ACTUALLY MUCH MORE LURKING IN THIS IMAGE THAT I WANT TO DRAW TO YOUR ATTENTION. THERE MANY DIFFERENT MODES OF SEX DETERMINATION REPRESENTED IN THIS IMAGE. HOW SEX DETERMINED IN MAMMAL? WE HAVE SEX CHROMOSOMES. FEMALES ARE XX, MALES ARE XY, NOT SURPRISINGLY SINCE WE'RE MAMMALS IN THIS IMAGE MAMMALS ARE HIGHLY OVERREPRESENTED. WE HAVE THIS LITTLE BIAS, WHERE SORT OF WE LIKE THE ANIMALS THAT LOOK LIKE US. HAVE EYES LIKE US ANY CASE ALL THE MAMMALS ARE XXXY. BUT THEN WE HAVE GOT WHAT DO WE HAVE HERE? OS INDIVIDUALS. THEY'RE BIRDS. HOW IS SEX DETERMINED IN BIRDS? IS IT XY XX? THERE ARE SEX CHROMOSOMES BUT IT'S THE FEMALE THAT HAS THE TWO DIFFERENT SEX CHROMOSOMES SO WE CALL THEM Z AND W. THEY'RE MARCHING THEY'RE GETTING READY TO MARCH ON TO THE ARC, TOGETHER WITH XY, XXXY AND OUT HERE IN THE WATER, WE HAVE ALLIGATORS OR CROCODILES. HOW IS SEX DETERMINED IN ALLIGATORS AND CROCODILE? BY THE TEMPERATURE WHICH THE EGG INCUBATES SO THEY NEVER BOTHER SEX CHROMOSOMES, BUT THEY'RE GETTING READY TO MARCH TO THE ARC. SO THE POINT IS THE COMMONNALTY ACROSS ANIMAL KINGDOM IS EXISTENCE OF MALE AND FEMALE. AND THAT PARTICULAR MECHANISMS BY WHICH MALENESS OR FEMALENESS ARE SELECTED VARIES CONSIDERABLY BUT THE -- WE HAVE THIS ANCIENT TRUTH WHICH WE HAVE ALL UNDERSTOOD SINCE CHILDHOOD. WHICH WE IN BIOMEDICAL RESEARCH COMMUNITY ARE STILL TRYING TO GRASP. LET ME PLAY THIS UP FURTHER. I WILL TAKE MY FAVORITE SPECIES, RIGHT HERE AT THE BOTTOM, TURTLES AND TURTOISES. IN THOSE IT'S ALSO TEMPERATURE DEPENDENT SEX DETERMINATION. WHAT DOES THAT MEAN? IT MEANS HERE WE HAVE A PAIR OF TURTLES UP TOP, AND IT MEANS IF WE LOOK AT THE INTERNAL ANATOMY IES OF A MALE TURTLE AND A FEMALE TURTLE, THEY ARE EVERY BIT AS DISTINGUISHABLE INTERNALLY AS ARE WE. AS MALE AND FEMALE. YET IN TURTLES THERE'S NO SEX CHROMOSOMES. MALE AND FEMALE ARE GENETICALLY IDENTICAL. YOU SHOULD SAY HOW CAN THIS BE? THIS DOESN'T FIT WITH -- I HAVE TAUGHT ABOUT THE -- I WAS TAUGHT THAT CHROMOSOMAL SEX DETERMINES GOD INIAL SEX DETERMINES PHENOTYPIC SEX SO WHAT DO YOU DO? THIS IS WORSE. WHAT IF YOU DON'T HAVE SEX CHROMOSOMES LET ALONE IF YOU'RE PUTTING ASIDE EFFECT OF GOD INIAL HORMONES WHAT IF YOU DON'T HAVE SEX CHROMOSOME? SO THE EXISTENCE OF TWO SEXES IS PURELY EPIGENETIC WHICH IS TO SAY IN TURTLES MEALS AND FEMALES HAVE THE -- MALES AN FEMALES HAVE THE SAME GENOME BUT READ IT DIFFERENTLY. THERE ARE TWO READINGS OF THE SAME GENOME. AND I WILL SUGGEST THAT IF I GO BACK TO THIS IMAGE, THAT IS WHAT WE'RE SEEING HERE, ACROSS THE AN MA'AM KING DOLL, THE GENOME IS RED IN TWO DIFFERENT WAYS MALE READINGS AND FEMALE READINGS OF THE GENOME ACROSS THE ANIMAL KINGDOM. IT HAPPENS TO BE WE'RE AN XXXY SORT OPPOSED TO RELYING ON TEMPERATURE DEPENDENCE. LET ME FLIT THAT FORWARD, AND SAY OKAY, HERE ARE OUR CHROMOSOMES HUMAN CHROMOSOMES. WE HAVE 23 PAIRS OF CHROMOSOMES IN OUR CELLS, HERE ARE THE 22 PAIRS THAT ARE INDISTINGUISHABLE BETWEEN MALES AND FEMALES. THEN COME IT IS 23RD PAIR, I WON'T SHOW IT YET BECAUSE I WANT TO TALK 22 PAIRS. IF WE DIDN'T -- IF WE HAD NEVER HEARD THE 23RD PAIR CHROMOSOMES WE SAY MALES AND FEMALES ARE ARE GENETICALLY IDENTICAL. THEY ARE GENETICALLY IDENTICAL IN MOST PAIRS MOST SEX DIFFERENCES PLAY OUT IN THESE 22 PAIRS. THESE -- WHAT I'M SAYING CHROMOSOMES ARE READ DIFFERENTLY IN MALES AND FEMALES. JUST AS IF WE HAVEN'T FORGOTTEN WHAT WE SHARED. THE KNOWLEDGE THAT WE SHARE WITH THE -- COMMON ANCESTORS WITH TURTLES. SO I THINK WE MIGHT DO WELL THINKING ABOUT THAT KNOW WHAT'S ARC PAINTING WE MIGHT DO WELL RATHER THAN STARTING WITH THE ASSUMPTION THAT ALL BIOMEDICAL RESEARCH SHOULD END THE SAME PLACE UNLESS PROVEN OTHERWISE, PERHAPS WE SHOULD START WITH THE ASSUMPTION THAT NO, MALES AND FEMALES ARE FUNDAMENTALLY DIFFERENT, WE SHOULD ASSUME THAT, IT'S NOT THE 1970s ANY MORE, IT'S NO LONGER THE BLANK SLATE. MAYBE WE SHOULD REALIZE THAT THIS IS JUST -- THIS PAIR OF SEX CHROMOSOMES TO WHICH I HAVE DEVOTED THE ENTIRETY OF M&A MY CAREER TO BE HONEST IS A LITTLE EMBELLISHMENT ON A MUCH OLDER DEEPER PERVASIVE TRUTH. WHICH IS THAT YEAH, FEMALES AMONG US HAVE TWO Xs AND MALES REPLACE WITH UNMATCHED PAIR OF X AND Y. BUT I WOULD LIKE TO SUGGEST THAT IF WE TAKE A DEEPLY COMPARATIVE BROADLY EVOLUTIONARY PERSPECTIVE ON THIS, WE SEE THAT IT HAS BEEN TRUE FOR A VERY LONG TIME THAT EVOLUTION TAUGHT OUR GENOMES AND TAUGHT THE GENOMES OF ALL THE SPECIES WE CAN IMAGINE TO READ THE GENOME IN TWO DIFFERENT WAYS. WANTED TO LEAVE YOU WITH THAT PARTING THOUGHT. THANK YOU. [APPLAUSE] >> ALL RIGHT. >> GOOD AFTERNOON MY NAME IS AMY (INAUDIBLE) OFFICE OF WOMEN'S HEALTH. IT IS MY PLEASURE THIS AFTERNOON TO SHARE WITH YOU A NEW ORWH RE SOURCE, IMINO IT WENT LIVE YESTERDAY. -- BY NEW IT WENT LIVE YESTERDAY SO YOU ARE THE FIRST PEOPLE TO SEE IT WHICH IS EXCISING FOR US. SO MANY OF YOU WE HOPE WILL REMEMBER IN 2002 ORWH PUBLISHED THE ORIGINAL NIH OUTREACH NOTEBOOK. THIS NOTEBOOK WAS DESIGNED THE ASSIST RESEARCH TEAMS AND FULFILLING RESPONSIBILITIES FOR PROPER CONDUCT OF CLINICAL RESEARCH. ORWH CONTINUES TO WORK INVESTIGATORS, PROGRAM OFFICIALS AND RESEARCHERS TO ENSURE WOMEN AND MINORITIES ARE ADEQUATELY REPRESENTED IN CLINICAL RESEARCH. BY WORKING WITH THESE RESEARCH TEAMS WE HAVE LEARNED A GREAT DEAL. SO WE HAVE TAKEN THE KNOWLEDGE BROUGHT TO 2015 AND CREATED A NEW UPDATESSED RESOURCE. WE TOOK A LOT OF CONTENT AND SEARCH FROM THE ORIGINAL NOTEBOOK BUT BROUGHT FORWARD TO A FOR USER FRIENDLY MORE ACCESSIBLE OUTREACH LEVEL. THE NEW NOTE BOOKER IS WEB-BASED AND INCLUDES UPDATED FONTS AND NEW FEATURES. SUCH AS AN EXTENSIVE LITERATURE REVIEW. CASE STUDIES, VIDEO CONTEMPT AND PRINT -- CONTENT AND PRINTABLE CHECKLIST FOR INVESTIGATORS INCLUDING BEST PRACTICES TO GUIDE RESEARCH TEAMS TO CREATING STUDIES THAT INCLUDE APPROPRIATE POPULATIONS FOR SEX GENDER RACE AND ETHNICITY. THE NEW OUTREACH TOOL KIT IS DIVIDED TO SEVEN SECTIONS. THE INTRODUCTION FEATURES WELCOME LETTER BY DR. PLATENN AS WELL AS VIDEO. SECOND RECRUITMENT AND RETENTION STRATEGIES, AND SEVERAL CASE STUDIES WHICH IDENTIFY WAYS RESEARCHERS OVERCOME BARRIERS TO RECRUITMENT. THE THIRD SECTION INCLUDES NIH POLICIES AS WELL AS HISTORY, GUIDELINES AND NIH DEFINITIONS. OF CLINICAL TRIALS AND OTHER COMMONLY USED TERMS. THE FOURTH SECTION ON HUMAN SUBJECTS PROTECTION COVERS INFORMED CONSENT, DSMB IRB AND THE LIKE. FIFTH IS HIPAA AND OMB FOLLOWING GUIDANCE P PIs ON REPORTING REQUIREMENTS REQUIRED BY THE NIH. ALL SUMMARIZED BY SECTION 7 SO HIGHLIGHTINGS THE KEY FEATURES OF THE TOOL KIT. THE FIRST IS THE LITERATURE REVIEW. WHAT EMERGED IN THE LITERATURE IS INVESTIGATORS NEED TO IMPLEMENT A RANGE OF STRATEGIES FOR THE TO ALIGN WITH NEEDS AND CONCERNS OF POPULATION THEY'RE TARGETING TO STUDY. WE KNOW SUCCESSFUL RECRUITMENT BEGINS WITH LEARNING ABOUT STUDY POPULATION. BUT ALSO IDENTIFYING WHICH BARRIERS MOST LIKELY BE ISSUES FOR MEMBERS OF THAT PARTICULAR POPULATION TO BE STUDIED. THE LITERATURE REVIEW PROVIDES A SECTION OF LITERATURE ON BARRIERS AND FACILITATORS RECRUITING WOMEN FROM DIVERSE BACKGROUNDS TO CLINICAL TRIALS. THERE IS NO SIMPLE SOLUTION TO THE CHALLENGE OF RECRUITING RETAINING WOMEN IN CLINICAL RESEARCH BUT THIS BROAD LITERATURE REVIEW CONFRONTS ON GOING CHALLENGES TO HELP INVESTIGATORS BE AWARE FROM THE BEGINNING TO DESIGN THE STUDY THAT TARGET IT IS CORRECT POPULATION. THE SECOND FEATURE TO HIGHLIGHT ARE THE CASE STUDIES. SO EACH CASE STUDY FEATURES SUMMARY OF THE TARGET POPULATION AND THE RECRUITMENT APPROACH USED BY CLINICAL TEAM. THESE ARE FOLLOWED BY BARRIERS OF THE TEAM FACED AND HOW THEY OVERCAME BARRIERS WITH SUCCESSFUL RECRUITMENT STRATEGIES AND THOUSAND THEY HELP WOMEN IN THEIR TRIALS WITH SUCCESSFUL RETENTION STRATEGIES. LASTLY, LESSONS LEARNED ARE SHARED BY EACH CLINICAL TEAM FEATURED IN THE CASE STUDIES. IF THEY COULD DO IT AGAIN WHAT WOULD THEY DO DIFFERENTLY? WHAT DID THEY LEARN? AND WHAT WOULD THEY SHARE WITH RESEARCHERS CONDUCTING SIMILAR PROJECTS IN THE FUTURE? SO ONE SUCH EXAMPLE IS ARIZONA CERVICAL CANCER PREVENTION UNIT. LED BY DR. FRANCIS GARCIA, THEY CONDUCT AD SERIES OF CLINICAL TRIALS FOCUSING ON CERVICAL CANCER. THEY IDENTIFIED SEVERAL BARRIERS IN THE STUDY. MANY WOMEN IN TARGET POPULATION HAD ECONOMIC CHALLENGES THAT MADE IT DIFFICULT TO TAKE THE TIME TO PARTICIPATE IN A TRIAL. SECONDLY, IN ADDITION MANY OF THE WOMEN HAD LIMITED FORMAL EDUCATION. AND WERE THERE FOR UNFAMILIAR WITH THE SCIENCE INVOLVED IN CLINICAL TRIALS AND PROCESS OF MEDICAL RESEARCH. FINALTRY THERE WAS LACK OF TRUST WITHIN THE COMMUNITY BETWEEN RESEARCH TEAMS AN POPULATIONS THEY INTENDED TO STUDY. SO RESEARCH TEAM TOOK THIS INFORMATION, AND EMPLOYED RECRUITMENT STRATEGIES TO OVERCOME BARRIERS, LINGUISTIC AND CULTURALLY COMPETENT STAFF MEMBERS WHO CONDUCTED THE OUTREACH EDUCATION AND CONSENT PROCESS FOR TRIALS. THESE WERE PEOPLE THE POPULATION COULD IDENTIFY WITH AND TRANSFER FELT THEY COULD TRUST. CONSEQUENTLY WOMEN WHO WERE CONSIDERING ENROLLENING THE TRIALS RECEIVED ANSWERS TO THEIR QUESTIONS IMMEDIATELY. FROM A PERSON WHO NOT ONLY SPOKE THEIR LANGUAGE BUT UNDERSTOOD THEIR CULTURAL BACKGROUNDS. THIS WAS CRUCIAL FOR THE SUCCESS OF THESE TRIALS. RESEARCHERS DEVOTED ENERGY TO DEVELOP A CONSENT PROCESS MEANINGFUL TO THESE WOMEN CONSIDERING JOINING THE TRIALS. THEY HAD TO TRANSLATE THE MANDATORY CONSENT LANGUAGE INTERPRET MATERIAL CULTURALLY AND PRESENT IN SUCH A WAY THAT POTENTIAL PARTICIPANTS COULD UNDERSTAND IT. THE CUMULATIVE PREVENTION TRIALS REQUIRE THAT ALL PARTICIPANTS ENROLL USE CONTRACEPTION. SINCE LARGE PERCENTAGE OF THIS POPULATION WAS UNINSURED AND AS I MENTIONED ECONOMICALLY CHALLENGED, THEY COULDN'T ALWAYS AFFORD CONTRACEPTION SO IN CREATING AND DESIGNING THE TRIAL, THE PIs AND RESEARCH TEAM FELT IT IMPORTANT THESE PARTICIPANTS RECEIVED FREE CONTRACEPTION AS INCENTIVE TO JOIN TRIAL. AS MENTIONED EARLIER THE HOW MANY SUBJECTS PROTECTION PROVIDES SEVERAL EXAMPLES OF NIH DEFINITIONS WE PROVIDE INFORM CONSENT EXAMPLES, INFORMATION ON SUBMITTING -- I'M SORRY, INFORMATION ON SUBMITTING TO A DATA SAFETY AND MONITORING BOARD, AND EDUCATION ON HUMAN SUBJECTS. THERE'S LINKS TO SEVERAL NIH WEBSITES USEFUL CONDUCTING THIS RESEARCH SUCH AS OFFICE OF EXTRAMURAL RESEARCH. THIS IS ONE DOCUMENT I MENTIONED EARLIER, THE OUTREACH RECRUITMENT CHECKLIST. SO THIS IS MEANT TO BE USED FOR CLINICAL RESEARCH TEAM BEFORE THEY BEGIN TO DESIGN THEIR TRIAL. IT HELPS DEFINE STUDY POPULATION FORM THE RIGHT TEAM AND ENLIST COMMUNITY SUPPORT FROM THE VERY BEGINNING IN THE HOPES THAT THEY WILL BUILD SUCCESSFUL TRIAL. IT ALSO IDENTIFIES BEST RECRUITMENT PRACTICES AND WAYS TO MARKET THE STUDY AND ADDRESS CULTURAL COMPETENCE. FINALLY OUTRICHEST STRATEGIES ARE EXPLAIN AS ELEMENTS OF OUTREACH HELP INVESTIGATORS ADDRESS BARRIERS TO RECRUITMENT AND FACILITATE SUCCESS IN RETAINING WOMEN IN CLINICAL RESEARCH. THESE ELEMENTS ARE GENERIC PRINCIPLES TO ENHANCE INCLUSION RECRUITMENT AND RETENTION OF RESEARCH SUBJECTS FOR MOST POPULATION GROUPS. ADDITIONALLY THE OUTREACH TOOL KIT INCLUDES VIDEOS AND TESTIMONIALS ABOUT INCLUSION OF WOMEN IN CLINICAL RESEARCH. WE HAVE A SHORT PREVIEW OF THE ONE VIDEO WITH FEATURE STORIES FROM NIH CLINICAL TRIAL PARTICIPANTS, NIH STAFF AND ORWH DIRECTOR DR. CLAYTON. THESE VIDEOS ARE NOT ONLY PART OF THE TOOL KIT BUT FURTHER DEVELOPED TO INDIVIDUAL VIDEOS TO BE SHARED WITH WOMEN ABOUT THE IMPORTANCE OF PARTICIPATING IN CLINICAL RESEARCH. >> CLINICAL TRIALS CLINICAL RESEARCH EXPERIMENT TESTING OUT NEW AND NOVEL IDEAS PERHAPS A NEW DRUG, PERHAPS A NEW DEVICE FOR THE FIRST TIME IN HUMANS. >> AT NIH AND RESEARCHERS BIOMEDICAL RESEARCHERS WE'RE ALL ABOUT TURNING THOSE DISCOVERIES INTO HEALTH AND OF COURSE HEALTH FOR EVERYONE, WOMEN, MEN, CHILDREN, OLDER INDIVIDUALS, EVERYONE FROM DIVERSE BACKGROUNDS. PATIENTS COME HERE FROM ALL OVER THE UNITED STATES AND WORLD TO REALLY BE PARTNERS IN THAT RESEARCH AND PARTICIPATE IN THAT SCIENTIFIC DISCOVERY. >> THEY WERE WONDERFUL PEOPLE THAT DID DEMYSTIFY THE RESEARCH ENVIRONMENT AND HUMANIZE IT AND WELCOMED ME INTO IT AND WELCOMED MY FAMILY INTO IT IN A WAY THAT YES MEETING RESEARCH GOALS BUT TAKING CARE OF US AS HUMAN AND ME AS A KID. >> MANY TIMES WHERE WE DON'T HAVE A LOT OF EVIDENCE ABOUT WHAT WORKS IN MEN VERSUS WOMEN OR MEN AND WOMEN. THAT IS VERY CHALLENGING. >> WOMEN PARTICIPATION IN CLINICAL TRIALS IS EXTREMELY IMPORTANT BECAUSE WE ARE -- HAVE TIRELY DIFFERENT SET OF ISSUES WHATEVER BODY SYSTEM YOU'RE WORKING WITH, IT'S DIFFERENT FROM A MAN AND FROM A CHILD SO THERE'S CERTAINLY DIFFERENCESES THERE WE NEED TO UNDERSTAND AND FOCUS AND REALIZE OUR ARE SPECIFIC TO WOMEN THAT MAYBE HAVEN'T BEEN STUDIED BEFORE AND IF WE DON'T TAKE ADVANTAGE OF WHAT WE HAVE NOW AND WE'RE NOT GOING TO SEE THE POSITIVE RESULTS. >> IT'S ENORMOUS GRATITUDE FOR ME, THAT PEOPLE LIKE US ARE ARE OUT THERE, RESEARCHERS LIKE US OUT THERE, WHO RISK THEIR LIVES TO FINDING OUT BETTER TREATMENTS FOR PEOPLE WITH ILLNESS. >> IT'S SO IMPORTANT WE AS WOMEN PARTICIPATE IN CLINICAL TRIALS AND OTHER RESEARCH PROJECTS. BECAUSE WHAT WE'RE DOING HERE TODAY WILL INFORM HEALTHCARE AND MEDICINE AND CAN -- IN 10, 20 YEARS. >> I CAN LIVE A FULL AND HEALTHY LIFE LIKE ANYONE ELSE CAN. THAT IS ONLY POSSIBLE POSSIBLE BECAUSE I PARTICIPATED IN THE CLINICAL TRIAL AND MANY OTHER PEOPLE DID BEFORE ME. >> I FELT LIKE HAPPY FOR ME, YES, HANDED MY LIFE BACK FROM DEATH'S DOOR BUT ALSO JUST LIKE WHAT INCREDIBLE SCIENCE THEY'RE DOING HERE. WHAT DOES THIS MEAN FOR OTHER PATIENTS DOWN THE ROAD? AND KNOWING THAT THIS CAN WORK FOR ME AND HAVING THEM FIGURE OUT HOW IT WORKED OR WHY IT WORKED. WILL LEAD TO IT HOPEFULLY WORKING FOR MORE PEOPLE. >> I THINK ALL WOMEN SHOULD CONSIDER PARTICIPATING IN CLINICAL RESEARCH. BECAUSE WE CAN LEARN SO MUCH ABOUT THE HEALTH OF WOMEN, THE HEALTH OF FAMILIES AND THAT CAN BENEFIT COMMUNITIES AND SOCIETY AS A WHOLE. >> I KNOW THAT INSPIRED ALL OF YOU TO JOIN THE CLINICAL TRIAL. INSPIRING. IN CLOSING I'M DECIDED TO -- EXCITED THE SHARE THE WEB ADDRESS AND TWITTER HASH TAG FOR THE OUTREACH AND DECEMBER SIMILAR NATION OF OUTREACH TOOL KITS KIT. I ENCOURAGE YOU PICK UP A KNOW NOTE CARD ON THE BACK TABLE AND TAKE IT BACK TO YOUR UNIVERSITY OR INSTITUTION AND SHARE THIS INFORMATION WITH YOUR COLLEAGUES. WE HOPE THIS WILL BE A GREAT RESOURCE FOR ALL OF YOU. THANK YOU. [APPLAUSE] DISSEMINATION. >> >> I WANT TO SHARE THAT THIS IS A WORK IN PROGRESS, THAT'S THE FIRST SET OF VIDEOS, THERE ARE MORE TO COME STAY TUNED FOR MORE FEATURES THE TO BE ADDED TO THAT OUTREACH TOOL KIT. SEE WHERE WE ARE HERE. WE HAVE A CHANGE IN THE REST OF OUR SCHEDULE. DR. LAUREN WOOD IS UNABLE TO BE WITH US TODAY DUE TO AN EMERGENCY IN HER FAMILY SO WE ARE GOING TO TAKE A FIVE -- WE'LL TAKE A FIVE MINUTE BREAK AND COME BACK AT 4 O'CLOCK AND HAVE A DISCUSSION. WE'LL SEE YOU BACK AT 4:00. SO WE'LL RESUME, I WANT TO SAY I DON'T THINK WE GAVE DR. PAGE A ROUNDS OF APPLAUSE AFTER THAT WONDERFUL MODERATING PANEL, I WANT THE THANK PANELISTS AS WELL. [APPLAUSE] >> I HAVE A QUESTION, DR. PAGE, WHAT WAS YOUR A HA MOMENT WHEN YOU BECAME A SEX DIFFERENCES PERSON? >> WELL, SO THE -- SO I ACTUALLY -- SO IN THE SUMMER AFTER FIRST YEAR MEDICAL SCHOOL I HAPPENED TO -- I STUMBLED INTO RESEARCH SITUATION WHERE I BECAME THE FIRST STUDENT ANYWHERE IN THE WORLD TO WORK ON WHAT WOULD BECOME THE HUMAN GENOME PROJECT. AND I WAS -- I MEAN, IT WAS THE TECHNOLOGY WAS UNBELIEVABLY PRIMITIVE AT THAT TIME, I WAS LOOKING AT THE FIRST LIBRARY OF THE HUMAN GENOME AND THERE WERE HUNDREDS OF THOUSANDS OF SNIPPETS OF THE HUMAN GENOME AND AT THAT POINT IT WAS NOT A HIGH THROUGH PUT OPERATION. I OPERATED WITH A TOOTHPICK, PICKING ONE AT A TIME. IT JUST HAPPENED THAT ONE OF THE FIRST -- ONE OF THE VERY FIRST CLONES FROM THIS SEA OF HUNDREDS OF THOUSANDS THAT I SELECTED PROVE TO COME FROM A SITE OF SHEER DNA SEQUENCE BETWEEN X AND Y CHROMOSOMES. THAT'S HOW I CHOSE MY CAREER WITH THAT TOOTHPICK. I'M NOT MAKING THIS UP. >> THANKS FOR SHARING THAT, DAVID. SO WE'RE QUOING TO SEGUE TO OUR LAST SESSION -- GOING TO SEGUE TO OUR LAST SESSION. I PROMISE IT'S GOING TO BE INTERESTING. I WANT TO MAKE SURE BEFORE YOU GO, ALL OF YOU HAVE PICKED UP THE INFO GRAPHICKIC ON THE BACK TABLE HERE, PLEASE TAKE SOME OF THOSE WITH YOU ALONG WITH THE NIH OUTREACH TOOL KIT THAT MS. ESTRETTA SO ABLY PRESENTED. I HAVE ONE QUESTION FOR EACH OF YOU, I WOULD LIKE TO GO AROUND THE TABLE AND HAVE EACH OF YOU SPEND A MINUTE OR LESS ANSWERING THIS QUESTION. SO THE QUESTION IS, CAN YOU NAME ONE SCIENTIFIC OR CLINICAL QUESTION THAT IS CRITICAL TO MOVING FORWARD IN RESEARCH-RELATED IN THE HEALTH OF WOMEN? ONE CLINICAL OR SCIENTIFIC QUESTION THAT IS CRITICAL TO MOVING FORWARD IN RESEARCH ON THE HEALTH OF WOMEN. I'M GOING TO BEGIN WITH THE MIDDLE BECAUSE YOU ARE BOTH LOOKING LIKE WHO IS GOING FIRST, I WILL START WITH DR. KASHUBA BECAUSE SHE HASN'T TALKED YET. THAT'S WHAT HAPPENS WHEN YOU DON'T TALK AT MY MEETING, YOU GET ASKED A QUESTION FIRST. >> A ONE THING THAT I AM VERY INTERESTED IN IS AS CLINICAL PHARMACOLOGIST IS THE DISPOSITIONS OF DRUGS IN TISSUES OF MALES VERSUS FEMALES. THIS RELATES PARTICULARLY TO THE HIV CURE AGENDA. WE HAVE ALREADY SEEN IN THE HIV PREVENTION FIELD THERE ARE SIGNIFICANT DIFFERENCES IN DRUG DISPOSITIONS BETWEEN MUCOSAL TISSUES AND PROTECTING MEN FROM HIV ACQUISITION COMPARED TO PROTECTING WOMEN. SO SOMETHING THAT'S PARTICULARLY IMPORTANT TO ME IS UNDERSTANDING HOW THOSE DIFFERENTS ALSO RELATE TO DISPOSITIONS OF DRUGS FROM THE BRAIN PARTICULARLY RELEVANT TO HIV AND ALSO RELEVANT TO OTHER AREAS. THAT WOULD BE MY QUESTION. >> THANK YOU. CLOE, THAT WAY. >> WELL THE QUESTION I'M FOCUSED ON RIGHT NOW, VERY INTERESTED IN UNDERSTANDING IS HOW TO LOWER WOMEN CHOLESTEROL? AND REDUCE CARDS YES VASCULAR RISK. AT ISSUE IS THAT WE NEED TO HAVE PHARMACEUTICALS THAT ARE BOTH EFFECTIVE AND WELL TOLERATED IN WOMEN. SO HOW MUCH OF THIS CAN WE HANDLE ON THE CLINICAL PRACTICE SIDE AND HOW MUCH DO WE NEED -- DO WE NEED DRUGS BETTER SUITED TO OPERATING WELL IN WOMEN? >> I THINK MY BIGGEST QUESTION IS HOW WE'RE ABLE TO EDUCATE THE YOUNG SCIENTIST REGARDING TERMS OF EXPERIMENTAL DESIGNS AND TO DECIDE APPROPRIATE EXPERIMENT TO ANSWER KEY QUESTIONS AND HOW TO APPLY ANALYSIS TO TEAR APART WHAT THEY'RE ACTUALLY INTERESTED IN. SO BECAUSE THAT GOES BECOME TO REPRODUCIBILITY ISSUES HERE AND WE HAVE SO MANY OUTCOMES NOT ABLE TO REPLICATE SO THE EDUCATION PART PLAYS A VERY IMPORTANT IN TERMS OF MISSION TO PROMOTE WOMEN'S HEALTH AND ALL THE EXPERIMENT HAS BEEN DESIGNED APPROPRIATELY AND ANALYZED. >> THANK YOU VERY MUCH. DAVID. >> SO WHAT'S ON MY MIND AND WHAT I'M THINKING ABOUT IS NOAH'S ARC. IS IT REALLY THE CASE THAT THE GENOME IS READ IN TWO DIFFERENT WAYS AND DIFFERENT ANIMALS? I'LL BE VERY INTERESTED IN SEE HOW THOSE DIFFERENT -- I'M CONVINCED THERE ARE TWO DIFFERENT READINGS OF THE GENOME ACROSS THE ANIMAL KINGDOM AND I'M INTERESTED TO SEE HOW SHARED OR DIFFERENT THOSE MALE FEMALE READINGS ARE, ACROSS THE ANIMAL KINGDOM BECAUSE IT WILL HAVE A LOT TO DO WITH USE OF ANIMALS IN STUDIES OF SEX DIFFERENCES. >> MARY. >> I HAVE TWO. ONE IS A FOLLOW-UP WITH ON HOW TO EDUCATE THE PUBLIC TO UNDERSTAND WHAT PARTNERSHIP AND RESEARCH MEANS AND HOW TO EMBRACE THAT? I THINK SOMETIME THERE'S NOT THAT LANGUAGE OF MUTUAL UNDERSTANDING. THEN THE OTHER QUESTION IS, WOMEN HAVE LONG LIFE EXPECTANCY, A LOT OF BABY BOOMER WOMEN ARE TOLD EXPECT TO LIVE TO BE 105. SO MY QUESTION, WHAT SHOULD WE DO EARLIER AND/OR BETTER TO HELP LIVE LONG LIVES HEALTHIER? >> THANK YOU, VALERIE. >> MINE WOULD BE PROBABLY MORE A POPULATION HEALTH QUESTION. WHAT IF WE FOCUSED ON ACHIEVING HEALTH EQUITY AND ACTUALLY REALLOCATED RESOURCES TO PEOPLE WHEN THEY NEED ANYTIME THE AMOUNT THEY NEED IN ORDER TO REACH OPTIMAL LEVEL OF HEALTH. SO IF WE STARTED TO FOCUS REARE SEARCH STUDIES AND RESOURCES TO GET THAT DISPROPORTIONATE IMPACT OF HIV ON YOUNG WOMEN OF COLOR. WHAT IF WE ACTUALLY PUT MORE RESOURCES TOWARD THAT VERSUS LOOKING AT GIVING THE RESOURCES TO THOSE POPULATIONS THAT ACTUALLY ALREADY HAVE STABILITY OR SEEING DECREASE IN INCIDENCE OF THE PROGRESS OF THE DISEASE TO MORE CHRONIC DISEASE SO WHAT IF WE ACTUALLY THOUGHT ABOUT ACHIEVING HEALTH EQUITY? >> THANK YOU, VALERIE. JUDY. ARE YOU UP? >> TWO THINGS, ONE, A BIG QUESTION ON DISCERNING THE DIFFERENCE BETWEEN SEX DIFFERENCES, BIOLOGICALLY AND DISPARITIES IN MALE AND FEMALE DIFFERENCES. I THINK THAT'S A REALLY BUG ONE, I THINK WE DON'T -- STILL DON'T KNOW WHAT WE DON'T KNOW YET AND IT WILL BE EXCITING TO FIND OUT MORE. THE OTHER IS MORE PRACTICAL ISSUE HOW TO MAKE IT -- MAKE THE IMPORTANCE OF THIS STAND OUT AT UNIVERSITY WHERE EVERYTHING IS NOW PERSONALIZED MEDICINE OR REGENERATIVE MEDICINE, BUT I WANT PEOPLE TO STUDY SEX DIFFERENCE ACE CROSS ALL FIELDS. HOW THE MAKE THAT A PRIORITY. TO UNIVERSITIES. >> JILL. >> SO I ALSO HAVE TWO THINGS, DO WE NEED TO RECKON ACCEPT ACTUALIZE SEX DIFFERENCES AS MORE THAN A BIMODAL CHARACTERISTIC? ESPECIALLY TRYING TO CREATE MODELS FOR THE HUMAN CONDITION WHERE IT'S NOT ALWAYS MALE FEMALE DIFFERENCE WE SHOULD BE LOOKING AT? AND THEN FROM A BASIC ANIMAL PERSPECTIVE HOW DO WE BUILD BETTER ANIMAL MODELS THAT BETTER REFLECT HUMAN CONDITION WE'RE TRYING TO FIND SOLUTIONS FOR? >> BACK TO YOU? >> IT MIGHT SURPRISE YOU TO SAY QUALITY OF PAIN CARE INSTITUTE OF MEDICINE HAS WRITTEN A REPORT HHS HAS WRITTEN, DEVELOPED SOME THINGS THAT WILL TALK ABOUT AS A PUBLIC HEALTH PROBLEM. I SPEND TIME WRITING ABOUT IT, DISPROPORTIONAL IMPACT OF RACIAL MINORITIES AND WOMEN SO I THINK THIS IS AN ISSUE THAT REALLY NEEDS TO BE ADDRESSED. IN A THOUGHTFUL MANNER. IT GOES TO WHAT MARY SAID IN REGARDS OF WHY DO WOMEN -- QUALITY OF LIFE GOING DOWN WHEN THEY AGE GOES TO -- PEOPLE NOT BEING PRESENT. SO NOT JUST COMORBIDITY MARKED BUT IT CAN BE -- IT IS, TOO OFTEN FOR PEOPLE OF CHRONIC PROBLEM, AND WHETHER IT'S JUST EYE CUTE PROBLEM OR RELATED TO CANCER, THAT'S AN ISSUE THAT NEEDS TO BE ADDRESSED, DISPROPORTIONATE IMPACT ON WOMEN, MORE IMPORTANT IMPACT ON WOMEN OF COLOR. THE OTHER THING THAT I WILL TALK ABOUT IS STRUCTURAL INEQUALITY, NOT JUST MEDICATIONS TO GIVE WITH INEQUALITIES TO GO BEYOND SOMEONE EATING TOO MUCH BACON. CONTRIBUTING TO HEALTH AND WELL BEING OF PEOPLE THAT ARE WITHIN THAT GO BEYOND, IF I TAKE YOUR BACON AND YOU EXERCISE, WHY SOME PEOPLE DIE BEFORE THEIR TIME? AND EVIDENCE TO PRACTICE THEM. THE LAST THING I WOULD TALK IS HOW TO THINK ABOUT IMPLEMENTING WHAT WE ALREADY KNOW. AND NOT CONTINUING TO RECREATE THE WHEEL CREATING NEW SCIENCE WE FEMALE TO DISSEMINATE >> CONNIE. I HAVE BEEN INTERESTED IN SEX AND SEX HORMONE AND OBESITY ENTERA. WHY IS OBESITY PROTECTIVE VERSUS INCREASE THE RISK BEFORE OR AFTER MENOPAUSE FOR EXAMPLE? WHY NOW THAT THE WOMEN HEALTH INITIATIVE TOOK AWAY ESTROGEN THERAPY DO WE JUST GIVE UP ALL TOGETHER OR ON MENOPAUSAL SYMPTOMS AND ISSUES? OR CAN WE KEEP LOOKING FOR SOME ORA LEAF? WHY DO THE ENVIRONMENTALISTS AT PURDUE FIND CONTAMINANTS FOR BIRTH CONTROL PILLS IN THE WATER MAKE SENSE CHANGES IN LOCAL FISH POPULATIONS? THINGS OF THAT NATURE. >> THANK YOU. >> HIGH DI. >> GREAT. I THINK SOME THINGS I'M INTERESTED IN FOCUSING INTO MORE POPULATION PERSPECTIVE AND SO VERY INTERESTED IN A REPORT THAT CAME OUT ABOUT SHORTER LIVES AND HOW WOMEN AND WOMEN IN RURAL AREAS, THOSE RURAL COUNTIES WHICH OUR HEALTH SYSTEM COVERS THAT, ARE DOING THE WORK OF ALL POPULATIONS THAT ARE IN THAT REPORT. SO LOOKING AT FACTORS BEHIND STRESS AND RESILIENCY, SOCIAL DETERMINANTS OF HEALTH WHETHER GENETIC BIOLOGIC AND ENVIRONMENTAL INTERACTION HOW ISSUES SUCH AS DOMESTIC VIOLENCE AFFECT MORE WOMEN AND KILL MORE WOMEN THAN A LOT OF DISEASES YET WE DON'T HANDLE THAT WELL AS MEDICAL ISSUE WHEREAS IT IS -- SEEMED LIKE IN PRACTICE INTERNAL MEDICINE PEOPLE WHO DO THE WORST AREN'T NECESSARILY THE PEOPLE WHO DON'T GET THE MEDICAL CARE BUT PEOPLE WHO HAVE THE OTHER ISSUES ISOLATION, MICE DIED ISOLATEED FROM OTHER MICE, THINGS THAT WE CAN'T EASILY MEASURE OR STUDY BECAUSE THERE'S SO MESSY BUT HAVE A HUGE INFLUENCE AND IT'S NOT JUST FINDING THE RIGHT PILL. SO TRYING TO MOVE THAT FORWARD SPECIFICALLY WITH REGARDS TO WOMEN MOTIVATED BY THAT REPORT PARTICULARLY, SEEMS LIKE SOMETHING WE SHOULD NOT IGNORE. AN INTERESTING QUESTION. >> THANK YOU, CAROLYN. >> GIVEN THAT ONE OF THE MOST HIGHLY REPLICATED EPIDEMIOLOGIC FINDINGS HAS BEEN THAT DEPRESSION IS MORE PREVALENCE IN WOMEN THAN IN MEN NOT JUST THIS NATION BUT AROUND THE WORLD AND GIVEN THE WHO HAS FOUND THAT DEPRESSION IS ONE OF THE GREATEST CAUSES OF DISABILITY IN WOMEN, I WOULD BE ADVOCATE OF TRYING TO TAKE ON THIS VERY SIGNIFICANT LARGE SCALE ISSUE. I THINK TIME TO TAKE IT ON IN A DIFFERENT WAY IN AN INTERDISCIPLINARY WAY. CLEARLY THERE ARE MANY OTHER BIOLOGIC PSYCHOSOCIAL FACTORS TO INTERACT TO MAKE THIS THE CASE, I THINK IT WOULD BEHOOVE US TO DO THAT GIVEN WE'RE NOW RECOGNIZING THE DEPRESSION ALSO IS CO-OCCURRING WITH CARDIAC DISEASE, AUTOIMMUNE ILLNESS. THESE ARE CLUES THAT WE CAN USE TO UNDERSTAND THIS BETTER. THAT'S WHAT I WOULD FOCUS ON. >> THANK YOU. >> I WAS STRUCK BY VIDEO OF BARBARA MCCCULSKY, WHERE SHE SAYS NOT SO MUCH A NEW INSTITUTE, SOMETHING I THOUGHT WOULD MAKE A SENSE BUT THEY WANT AN OFFICE BECAUSE THE OFFICE COULD HAVE -- A FINGER COULD HAVE AN INFERENCE OF ALL THE OTHER INSTITUTES AND I THINK THAT THIS CROSS-CUTTING ACTION IS IMPORTANT ALSO IN FIELD OF STUDYING SEX DIFFERENCES. THIS IS SOMETHING I LEARNED FROM PARTICIPATING IN THE ORGANIZATION FOR STUDY OF SEX DIFFERENCES, THE OSSD, PEOPLE THAT STUDY SEX DIFFERENCES ALL KIND OF DIFFERENT COMMENTS -- TELL THEIR STORY AND LISTEN TO EACH OTHER AND MAKE ME REALIZE STUDYING SEX DIFFERENCES IN MY FAVORITE ORGAN, THE BRAIN, IF I DO THAT, AGAINST THE WHOLE BODY PERSPECTIVE I UNDERSTAND MUCH BETTER SEX DIFFERENCES COME FROM, WHAT THEY'RE DOING AND WHY THERE ARE ILLNESSES THAT HITS THE ORGAN OF CHOICE IN MALES AND FEMALES SO I WOULD LIKE TO SEE THIS WHOLE BODY PERSPECTIVE EXPAND THROUGH SEX DIFFERENCES RESEARCH. >> THANK YOU. ARE THERE ITEMS ANYONE WANTS TO BRING UP FOR DISCUSSION BEFORE WE CLOSE? DR. GREEN? >> O DO YOU WANT TO GO FIRST? >> GO AHEAD. >> YOU GO FIRST THEN I'LL GO. >> SURE? >> YEAH. >> OKAY. WELL, IT'S TIME TO MAKE A MOTION. I WANT TO PRESENT A CONCEPT AND SOME INTRODUCTORY REMARKS. I THINK AT 25 YEARS THE CHALLENGE OF THE OFFICE RESEARCH WOMEN'S HEALTH IS ALSO ABOUT DISSEMINATING COMMUNICATING WHAT WE DO, WHAT'S IMPORTANT, WHY IS IT IMPORTANT. SO I HAVE PUT TOGETHER A LITTLE SUBCOMMITTEE. AND MY SUBCOMMITTEE BELIEVES WE SHOULD THINK BIG. WHAT DOES THINKING BIG MEAN? IT BASICALLY MEANS WE CAN DEVELOP A SERIES OF LECTURES WHICH COULD OCCUR THREE OR FOUR TIMES A YEAR. THEY HAVE BEEN NAMED LECTURES. WE HAVE THE PEN LECTURE, WE HAVE THE MCCULSKY LECTURE, THE KIRSCH LECTURE AND HEELEY LECTURE. YOU LIKE THAT? >> WE HAVEN'T GOTTEN STARTED YET. THAT'S HOW WE ROLL. THEY WOULD OCCUR FOUR TIMES A YEAR. SINCE WE MEET TWICE A YEAR, WE WANT TO POSE ARING THESE LECTURES, THE MCCULSKY AND PEN LECTURE COINCIDING AT SOME POINT THE DAY BEFORE OR AFTER THIS MEETING. DECREASE TRAVEL EXPENSES AND MEMBERS OF THIS COMMITTEE COULD ACTUALLY ATTEND. WITH THAT PARTICULAR MEETING, WE WOULD HAVE SOME SIMILAR POSE YUM. WE WOULD REQUEST, WE WOULD LIKE TO SEE PARTNERING WITH THAT, SO MAYBE PARTNER WITH SOMETHING LIKE NATIONAL INSTITUTE OF AGING, NATIONAL INSTITUTES OF NURSING RESEARCH, SOME PARTNERING. THE LECTURE LIKE THE PENN LECTURE YOU DECIDED ON BUT M,CCULSKY LECTURE, FOR THOSE THAT DON'T KNOW SENATOR MCCULSKY SHE'S BELOVED BY HER COMMUNITY AND A STAUNCH ADVOCATE FOR THE NIH. I THINK PROBABLY AS TOUGH AS HE IS, SHE'S ALSO COMPASSIONATE AS SHE IS. SHE WAS STARTED AS A COMMUNITY ORGANIZER AND SO REALLY ABOUT -- SOCIAL WORKER. AND SO FOCUSD ON AGING AND THINGS OF THAT NATURE SO WE THOUGHT THE MCCULSKY LECTURE WOULD BE NEAT TO HAVE SOMEBODY TALK ABOUT THE ROLE OF SOCIAL SCIENCES, SOCIAL WORKERS AND THINGS OF THAT NATURE. P P P SO STILL NEEDS TO BE FLESHED OUT BUT IT WOULD BE A SPIRIT TO HOW WE THINK ABOUT PATIENTS AND PATIENT CARE, PEOPLE WHO PARTICIPATE -- WHO ARE PARTICIPANTS IN OUR STUDIES. THE OTHER TWO LECTURES, THE KIRSCH LECTURE WE THOUGHT IN THE CONTEXT OF EMERGING LEADERS AND WOMEN IN THE SCIENCE OF WOMEN WITH'S HEALTH. AND THE HEELEY LECTURE WOULD BE ONE ABOUT SENIOR LEADERSHIP SO WE TALKED TO THE KIRSCH LECTURE SHE HAS THE THEATER NAMED AFTER HER, SHE HAS A COUPLE OF FUNDING MECHANISMS. I FOUND HEELEY DEAN OF MEDICAL SCHOOL, SHE WORKED IN GOVERNMENT, WORKED IN NON-PROFIT SECTOR AND WAS REALLY A SENIOR LEADER SO WE THOUGHT THAT LECTURE WOULD FOCUS ON THE CHALLENGES OF MAINTAINING THE PIPELINE TO SENIOR LEADERSHIP SO WOMEN WOULD GO INTO THAT, WHAT'S GOOD FOR WOMEN IS GOOD FOR MEN. SO THOSE WOULD BE THE FIRST SERIES OF LECTURES, SO WE EITHER GO THREE TIMES A YEAR OR FOUR TIMES A YEAR WE HOPE WOULDN'T BE SO ONEROUS ON THE STAFF BUT WITH THREE MORE HIGHLIGHT THE OFFICE RESEARCH WOMEN'S HEALTH, THAT'S PART ONE. PART TWO IS WE FELT REALLY IMPORTANT TO THINK ABOUT THE PEOPLE WHO WERE ORIGINAL CO-SPONSORS AND SIGNERS ON THIS PIECE OF LEGISLATION, I DON'T HAVE THAT. BUT I DO KNOW PAT SCHROEDER WAS THERE, CONNIE MORELLA LIMB PEEIA SNOW AND SOMEBODY ELSE SO WE HAVE TO LOOK THAT THE BUT WE THOUGHT IT A UNIQUE OPPORTUNITY TO CREATE FELLOWSHIPS OR INTERNSHIPS. STARTING -- SO WE THOUGHT THIS IS NOT AS WELL THOUGHT OUT BUT EVEN IN PLACES LIKE BALTIMORE, WHERE SENATOR MCCULSKY REPRESENTED, WE KNOW BALTIMORE HAD CHALLENGES, WE WITH ALSO KNOW THERE ARE CHALLENGES IN GETTING THAT PARTICULAR POPULATION ONE TO PARTICIPATE AND CLINICAL TRIALS, TWO TO ADVANCE IN THE PIPELINE. COULD WE THINK ABOUT SOMETHING IN THAT AREA SINCE NOT TOO FAR AWAY, METRO -- COUPLE OF METRO STOPS AWAY. TWO, THINK ABOUT SOMEBODY EVEN HIGH SCHOOL LEVEL SUMMERTIME HERE AMONG PEOPLE WHO WOULD BE WILLING TO MENTOR THEM. THAT'S BASICALLY THE PROPOSAL. >> TIME FOR FEEDBACK. DISCUSSION. >> DISCUSSION. >> CLEARLY WE HAVE TO PUT MORE MEAT TO THE BONE BUT I THINK ONE OF THE OUTCOMES WOULD BE FIRST OF ALL RECOGNITION OF REALLY WHAT IS -- THE IMPACT OF WHAT OCCURRED 25 YEARS AGO AND CREATE SUSTAINABILITY AND VISIBILITY AROUND THAT BUT THEN ALSO PART OF THAT SUSTAINABILITY IS ACTUALLY CONTINUING TO KEEP IT IN THE FOREFRONT OF THIS NEXT GENERATION. WHAT'S WHY THE MENTORSHIP OPPORTUNITIES, BECAUSE EVEN IF THERE WERE KIDS GOT INTERESTED IN PUBLIC POLICY AND THEY CAME EVEN TO THESE MEETINGS, THAT WOULD BE IMPACTFUL TO WHAT THEY THINK ABOUT WHAT'S POSSIBLE WHEN GOING TO COLLEGE OR GRADUATE HIGH SCHOOL OR WHATEVER THEY KNOW WHAT'S POSSIBLE AND THERE ARE SOME WAYS THAT WE CAN DEFINITELY DO THAT. BUT MAIN LECTURESHIPS THAT FOCUS ON CERTAIN AREAS, AND BEING VERY INTENTIONAL ABOUT THEM WHEN HAVING OUR MEETINGS, WOULD BE IMPACTFUL ALSO TO BRING IN OTHER PEOPLE. WHO ONE NECESSARILY SIT IN OUR AUDIENCE, WE CAN WEBCAST ALSO TO BE ENGAGED UNDERSTANDING THE WORK YOU'RE DOING. >> OTHER DISCUSSION? >> I WENT TO THE UNIVERSITY OF MARYLAND SCHOOL OF NEWSING AND (INAUDIBLE) ACT WAS A NURSE AND SHE WAS BARBARA MCCULSKY'S PARTNER AS A SOCIAL WORKER BACK IN THE DAY IN BALTIMORE CITY SO I HEARD WONDERFUL STORIES ABOUT BOTH OF THEM. AND WE ALSO SAW BARBARA MCCULSKY TALK ABOUT YOU DON'T LOOK LIKE SOMEBODY THAT SHOULD BE IN CONGRESS BUT SHE ENVISIONED IT. WOULD BE WONDERFUL FOR PEOPLE TO KNOW WHERE WE HAVE BEEN WHERE WOMEN WHO DON'T LOOK THE PART OR HAVEN'T BEEN AT THE TABLE HAVE OPPORTUNITY BECAUSE OF WOMEN THAT WENT BEFORE US, TO HAVE ANOTHER GENERATION GOING FORWARD TO DO THIS. SO THAT'S WHAT WE HAVE DONE IN OUR -- IT'S NOT BEEN A LOT WELL THOUGHT OUT YET BUT SOMETHING GETTING THEM TO THE FUTURE AS WELL AS ACKNOWLEDGING THE PAST. MIGHT I SUGGEST WE MIGHT IN THE INTEREST OF TIME WOULD THE COMMITTEE BE INTERESTED IN PUTTING FORWARD A MOTION AROUND SOUNDS RECOGNITION OF THE FORM OTHER OF OFFICE IN SOME APPROPRIATE WAY TO INCORPORATE VALUES AND MISSION AREAS OF THE OFFICE, MAINLY THE SCIENCE INCLUSION AND CAREERS. SOMEBODY LIKE TO MOVE THAT? >> SO I HAVE A MOTION. THE MOTION IS THAT WE WILL PUT TOGETHER A LECTURE SERIES AND PROGRAMMATIC THAT FOCUSES ON ON THE FOUR MOTHERS. DEVELOP OFFICE OF RESEARCH AT WOMEN'S HEALTH AT THE 25th ANNIVERSARY FOCUS ON SCIENCE INCLUSION AND CAREER DEVELOPMENT. >> I HAVE A MOTION. MOTION SECONDED SO WE CAN CALL THE QUESTION, ALL THOSE IN FAVOR. >> AYE. >> ANY OPPOSED. ANY ABSTAINING? MOTION CARRIES. OF COURSE YOU DO UNDERSTAND YOUR ADVISORY ROLE HERE, WE WOULD BE HAPPY TO TAKE THAT UP IN YOUR ADVISORY CAPACITY AND I APPRECIATE THE INCREDIBLE DISCUSSION THAT WE HAVE HAD FROM THE MEMBERS TODAY. THANK YOU, VERY, VERY MUCH FROM ALL OF YOUR CONTRIBUTIONS, EVERY SINGLE ONE OF YOU CONTRIBUTED TO THIS MEETING. I WANT TO THEY CAN OUR SPEAKERS, I ALSO WANT TO THANK ORWH STAFF WHO HAS BEEN WORKING TIRELESSLY FOR THIS MEETING AND FOR ALL THE OTHER ACTIVITIES THAT HAVE BEEN SIGNIFICANT OVER THE LAST YEAR AND ACKNOWLEDGE CONTRACT SUPPORT ALSO WORKING WITH US VERY CLOSELY. STAY TUNE FOR MORE IN THE UPCOMING YEAR, WE SHALL BE IN TOUCH MORE REGULARLY, TAKE THE INFO GRAPHIC WITH YOU. WHEN YOU GO. SAFE TRAVEL, SEE YOU IN A COUPLE OF MONTHS. THANK YOU.