>> WELCOME TO THE 46TH MEETING OF THE NIH ADVISORY COMMITTEE FOR RESEARCH ON WOMEN'S HEALTH. WE ARE VIDEOCASTING LIVE, SO I WANT TO MAKE SURE YOU'RE AWARE OF THAT. WE'RE SORRY WE'RE STARTING A LITTLE BIT LATE. BUT I'M GOING TO TURN IT OVER TO MS. LIZ SPENCER TO DO SOME OPENING LOGISTICAL AND OPERATIONAL REMARKS. >> GOOD MORNING. THANK YOU FOR COMING AND GLAD TO HAVE YOU ALL HERE FOR THE 46TH COMEETING. THIS MEETING IS OPEN TO THE PUBLIC, BROADCAST LIVE ON THE NIH VIDEOCAST NETWORK AND BEING RECORDED. RESTROOMS ARE LOCATED OUTSIDE NEAR THE ELEVATOR. THERE'S A STATION FOR COFEE AS WELL AS A COFFEE SHOP LOCATED ON THE FIRST FLOOR, ALL COUNCILMEMBERS HAVE THE OPTION OF PARTICIPATING REMOTELY FOR ONLY ONE MEETING A YEAR, NOTICE. SO NOW I'D LEAK TO GO AROUND THE TABLE AND ALLOW EVERYONE TO INTRODUCE THEMSELVES. PLEASE REMEMBER TO TURN YOUR MICROPHONE ON AND SPEAK INTO THE MICROPHONE DURING THE MEETING. STATE YOUR NAME BEFORE SPEAKING SO THAT THE REMOTE PARTICIPANTS AND NOTE TAKER AND THE VIDEOCAST OBSERVERS WILL KNOW WHO IS MAKING THE COMMENTS. SO IF WE COULD GO AROUND THE TABLE. >> HELLO. I'M MARSHAS TE. FANEK, DIRECTOR OF THE WISDOM CENTER AT STANFORD. WE GIVE A LOT OF C GRANTS TO TRY AND STIMULATE RESEARCH IN BOTH SEX DIFFERENCES AND WOMEN'S HEALTH. I TEACH A LOT OF CLASSES ON SEX AND GENDER AT STANFORD AND I'M STILL DOING THE WOMEN'S HEALTH INITIATIVE, IT GOES ON AND ON, AND WE HAVE A HUGE STUDY WITHIN THE WHI CALLED WISH, WHICH IS THE WHI STRONG AND THEY HEALTHY, IT'S A HUGE PHYSICAL ACTIVITY TRIAL. WE RANDOMIZE 50,000 WOMEN TO GETTING INTERVENTION OR NOT FOR HEART DISEASE, AND WE'LL SEE HOW IT GOES. >> HI. MY NAME IS ANNA MARIA LOPEZ. I HAVE RECENTLY MOVED TO JEFFERSON IN PHILADELPHIA, AND VERY EXCITED TO BE THERE. I'M PROFESSOR OF MEDICINE, VICE CHAIR OF MEDICAL ONCOLOGY, AND DEVELOPING THE CANCER SERVICE LINE FOR THE NEW JERSEY AFFILIATE. I RECENTLY MOVED FROM UTAH, WHERE WE HOSTED THE SEX AND GENDER EDUCATION CONFERENCE AND LOOKING FORWARD TO BRINGING THAT TO -- HOPEFULLY BRINGING THAT TO JEFFERSON IN 2020. AND HAD WORKED WITH THE WOMEN'S HEALTH INITIATIVE WHEN I WAS AT THE UNIVERSITY OF ARIZONA. >> WELCOME. I'M SHARON HUNTER, THE ASSOCIATE DIRECTOR FOR THE BASIC AND TRANSLATIONAL RESEARCH PROGRAM HERE AT ORWH. GOOD MORNING. >> HI, I'M WENDY KOHRT FROM UNIVERSITY OF COLORADO, PROFESSOR OF MEDICINE IN THE DIVISION OF GERIATRIC MEDICINE, THE CHAIR IN WOMEN'S HEALTH RESEARCH AND DIRECTOR OF OUR SPECIALIZED CENTER OF RESEARCH ON SEX DIFFERENCES, NOW SPECIALIZED CENTER OF RESEARCH EXCELLENCE ON SEX DIFFERENCES. PLEASURE TO BE HERE TODAY. >> GOOD MORNING, EVERYONE. I'M SAMIA NOURSI, ORWH ASSOCIATE DIRECTOR FOR SCIENCE POLICY PLANNING AND A ANALYSIS. I JOINED ORWH ABOUT SIX MONTHS AGO. I CAME FROM NIDA, WHERE I WAS THERE FOR 12 YEARS. MY BACKGROUND IS IN MATERNAL HEALTH, INTIMATE PARTNER VIOLENCE, SUBSTANCE ABUSE AND TRAUMA. >> GOOD MORNING, EVERYONE. MY NAME IS MARGARETBEVANS. GOOD TO SEE ALL OF YOU HERE TODAY. >> GOOD MORNING, CAROLYN MISSOURI, I'M PROFESSOR IN WOMEN'S HEALTH RESEARCH AT YALE MEDICAL SCHOOL AND PROFESSOR OF PSYCHIATRY AND PSYCHOLOGY AND DIRECTOR OF WOMEN'S HEALTH RESEARCH AT YALE, WHICH IS OUR INTERDISCIPLINARY RESEARCH CENTER WHICH IS NOW 20 YEARS OLD. >> I'M LOUISE MCCULLOUGH, UNIVERSITY OF TEXAS IN HOUSTON. I DO A LOT OF BASIC AND CLINICAL TRANSLATIONAL STUDIES LOOKING AT SEX DIFFERENCES, BOTH IN THE LABORATORY AND HOW THEY INFLUENCE STROKE OUTCOMES. >> HI, I'M AMY PALLOR, RELATIVELY NEW MEMBER. I AM PROFESSOR AND CHAIR OF DERMATOLOGY AT NORTHWESTERN AND I'M ALSO PROFESSOR OF PEDIATRICS. I AM ON THE BOARD OF OUR WOMEN'S HEALTH RESEARCH INSTITUTE AND ALSO WE HAVE A PROGRAM WITHIN OUR DEPARTMENT THAT FOCUSES ON WOMEN'S SKIN HEALTH. I'M THE PRINCIPAL INVESTIGATOR OF OUR SKIN DISEASE RESEARCH CENTER, WHERE ONE OF OUR AREAS OF FOCUS HAS BEEN ON LOOKING AT SEX DIFFERENCES IN THE RESEARCH LAB BETWEEN MALE AND FEMALE AND I WILL REMIND EVERYONE MOST OF WHAT WE KNOW ABOUT DERMATOLOGY HAS BEEN BASED ON SKIN CELLS, SO THAT'S VERY IMPORTANT. I'M GLAD TO BE HERE AND FOCUS IN MY CLINICAL ACTIVITIES ON PEDIATRIC DETERMINE DERMATOLOGY WITH AN EMPHASIS ON TEENAGE GIRLS. >> NOEL BARRY MERRS, CLINICAL INVESTIGATIVE CARD YOL CARDIOLOGIST, DIRECT THE WOMEN'S ISCHEMIA SYNDROME EVALUATION AND AM THE CARDIOLOGY LEAD ON THE NEW MOMS TO BE, THE NATIONAL INSTITUTES OF HEALTH, 30 YEARS OF STUDYING EXCLUSIVELY WOMEN FOR THAT SAME REASON, ALL THE CARDIOVASCULAR DISEASE WAS PREDOMINANTLY A MALE PROTOTYPE, AND WE'VE HAD GOOD SUCCESSES BUT A LOT MORE WORK TO COME. >> HI, EVERYONE. MY NAME IS ANNA LANGER, I COME FROM THE HARVARD SCHOOL OF PUBLIC HEALTH WHERE I AM THE DIRECTOR OF THE WOMEN IN HEALTH INITIATIVE, ALSO PROFESSOR IN GLOBAL HEALTH AND POPULATION DEPARTMENT AND I WORK VERY CLOSELY WITH MY COLLEAGUE DR. GOLDSTEIN IN A NEW INITIATIVE CALLED THE HEART AND BRAIN INITIATIVE. YESTERDAY WE ANNOUNCED A NEW FELLOWSHIP CALLED THE LEAD FELLOWSHIP, LEAD STANDS FOR LEARN, ENGAGE, ADVANCE AND DISRUPT. THAT IS FOR EMERGING GLOBAL FEMALE GLOBAL HEALTH LEADERS AND WAYS TO NURTURE THEIR LEADERSHIP SKILLS, SO WE ARE VERY EXCITED ABOUT THIS NEW DEVELOPMENT. >> GOOD MORNING. MY NAME IS KIMBERLY GREGORY. I'M PROFESSOR AND VICE CHAIR OF THE DEPARTMENT OF OB-GYN AT CEDARS-SINAI MEDICAL CENTER, MATERNAL FETAL MEDICINE SPECIALIST. MY RESEARCH HAS BEEN IN DEVELOPING QUALITY INDICATORS FOR CHILDBIRTH AND MOST RECENTLY PATIENT-REPORTED OUTCOMES FOR CHILDBIRTH. >> HI, PROFESSOR OF NEUROSCIENCE AT GEORGIA STATE UNIVERSITY, I'M THERE ALSO THE ASSOCIATE VICE PRESIDENT FOR RESEARCH. I'M A PAST PRESIDENT OF THE ORGANIZATION FOR THE STUDY OF SEX DIFFERENCES. I'M STUDYING SEX DIFFERENCES MYSELF IN THE BRAIN. I ASK THE QUESTION HOW DO YOU GET THEM AND ONCE YOU HAVE THEM, WHAT THEY'RE REALLY DOING FOR YOU. >> SABRE KLEIN, I AM AN ASSOCIATE PROFESSOR OF MOLECULAR MICROBIOLOGY AND IMMUNOLOGY AT THE JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH. I AM A CO-DIRECTOR OF THE JOHNS HOPKINS CENTER FOR WOMEN'S HEALTH SEX AND GENDER RESEARCH AND THE P.I. OF A NEWLY IMPLEMENTED SCORE FOCUSED ON SEX AND AGE DIFFERENCES IN IMMUNITY TO INFLUENZA, AND I AM THE CURRENT PRESIDENT OF THE ORGANIZATION FOR THE STUDY OF SEX DIFFERENCES. >> HI, I'M RACHEL JONES. I'M ASSOCIATE PROFESSOR AT THE SCHOOL OF NURSING AT NORTHEASTERN UNIVERSITY IN BOSTON. WE RECENTLY COMPLETED -- AND MY SPECIALTY IS HIV PREVENTION SCIENCE IN URBAN WOMEN. WE RECENTLY COMPLETED A CLINICAL TRIAL THAT WAS FUNDED BY NIH TO TEST THE EFFECT OF A SOAP OPERA SERIES CALLED "LOVE, SEX AND CHOICES" ON REDUCING HIV RISK AND INCREASING HIV TESTING IN PREDOMINANTLY URBAN BLACK WOMEN. WE SCREEN 5,000 WOMEN, RECRUIT PRIMARILY THROUGH FACEBOOK, AND OUR SAMPLE SIZE IS CLOSE TO A THOUSAND, SO WE'VE COMPLETED OUR DATA COLLECTION AND WE'RE NOW DOING ANALYSIS AND I'M USING THIS AS AN OPPORTUNITY TO SAY LOVE, SEX AND CHOICES IS AVAILABLE FOR VIEWING AND USE 24/7 FOR ANY1 WHO WANTS TO. >> SAY THE NAME AGAIN? >> THE NAME AGAIN OF THE PROGRAM?" LOVE, SEX AND CHOICES." I'LL SEND OFF THE URL. >> GOOD MORNING. I'M WENDY BREWSTER. I'M AT UNIVERSITY OF NORTH CAROLINA IN CHAPEL HILL. I'M IN THE DEPARTMENT OF OBSTETRICS AND GYNECOLOGY AND I ALSO HAVE AN APPOINTMENT IN THE SCHOOL OF PUBLIC HEALTH AND EPIDEMIOLOGY. I AM THE DIRECTOR OF THE CENTER FOR MEN'S HEALTH RESEARCH AND THAT'S A CENTER RESPONSIBLE FOR FACILITATING TRENDS, DISCIPLINARY WORK, NOT ONLY ACROSS THE SCHOOL OF MEDICINE BUT ACROSS THE INSTITUTION. I MYSELF AM A GYN ONCOLOGIST AND MY AREAS OF INTEREST, MOLECULARLY, ARE MICROBIOME AND HOW THAT AFFECTS OUTCOME AND DISPARITIES IN OUTCOMES, AND THEN MORE GENERALLY, USING LARGELY -- TO MAP WHAT ARE FACTORS THAT MAKE CERTAIN GROUPS HAVE A DISPARATE OUTCOME WHEN BEING TREATED FOR THE SAME TYPE OF MALIGNANCY. >> I'M JUDY REAGANSTEINER, PROFESSOR OF MEDICINE AT THE UNIVERSITY OF COLORADO SCHOOL OF MEDICINE, CHAIR OF WOMEN'S HEALTH RESEARCH AT THE UNIVERSITY, I AM THE DIRECT TOFORT CENTER FOR WOMEN'S HEALTH RESEARCH WHERE WE FOCUS ON DOING CUTTING EDGE RESEARCH PRIMARILY IN CARDIOVASCULAR HEALTH, DIABETES AND MENTAL HEALTH, AND CENTER NOW HAS THREE CHAIRS TOTAL. SO WE'RE WORKING BUT -- ONE OF OUR GOALS ARE TO DO THE RESEARCH TO MENTOR THE YOUNG AND TO EDUCATE THE PUBLIC AND OUR WORK IS ACROSS THE LIFESPAN. MY RESEARCH IS IN THE AREA OF CARDIOVASCULAR CONSEQUENCES OF TYPE 2 DIABETES IN LOOKING AT THE SEX DIFFERENCES IN THAT POPULATION OF PEOPLE WITH DIABETES. >> THOSE ON THE PHONE WHO ARE JOINING US REMOTELY, COULD YOU PLEASE INTRODUCE YOURSELVES? >> DR. CHEN OR DR. PAIGE? THEY MAY JOIN US LATER. SO I'M GOING TO PAUSE FROM OUR LOGISTICS SO THAT DR. CLAYTON CAN INTRODUCE OUR NEXT SPEAKER, AND WE CAN HEAR FROM NIH LEADER SHIP. DR. CLAYTON. >> GOOD MORNING, EVERYONE. WE HAVE AN EXCITING AGENDA PLANNED FOR YOU TODAY, STARTING WITH AN UPDATE FROM NIH LEADERSHIP. I'M REALLY DELIGHTED TO INTRODUCE DR. LAWRENCE TABAK, THE PRINCIPAL DEPUTY DIRECTOR OF NIH. DR. TABAK WAS THE DIRECTOR OF THE NATIONAL INSTITUTE ARE DENTAL AND CRANIOFACIAL RESEARCH FOR MANY YEARS BEFORE BECOMING PRINCIPAL DEPUTY DIRECTOR OF NIH. HE IS AN ACCOMPLISHED RESEARCH CLINICIAN IN THE FIELD OF DENTISTRY WHO STILL IS ACTIVE IN THE LABORATORY AS A SENIOR INVESTIGATOR AT NIDCR. HIS LAB STUDIES THE FUNCTIONS AND BIOSYNTHESIS OF OLGLYCANS. THANK YOU FOR BEING WITH US TODAY. >> GOOD MORNING, EVERYBODY. IT'S REALLY DELIGHTFUL TO BE HERE. USUALLY WHEN I SHOW UP TO MEETINGS, THERE'S A SORT OF SLUMPING OF SHOULDERS BECAUSE EVERYBODY REALIZES FRANCIS CAN'T BE HEREMENT HERE. SO INDEED HE'S EITHER IN BOSTON OR NEW YORK TODAY, I'VE LOST TRACK, BUT HE'S NOT IN TOWN. BUT HE DOES SEND YOU HIS BEST WISHES AND GREETINGS. SO I WILL TRY AND GET YOU BACK ON TIME BY BEING SUCCINCT IN MY OPENING REMARKS. THAT IS NOT MY SLIDE. BUT I'M HAPPY TO TALK ABOUT THAT IF YOU'D LIKE. THANK YOU. OKAY. SO REALLY, MY MAIN PURPOSE FOR BEING HERE THIS MORNING IS TO THANK ALL OF YOU. TO THANK THE MEMBERS OF THE COMMITTEE AND TO THANK THE MEMBERS OF THE ORWH STAFF AND THE LARGER NIH COMMUNITY, BECAUSE YOU HAVE ALL BEEN HARD AT WORK ON THE NEW STRATEGIC PLAN, WHICH YOU WILL HEAR SORT OF A LITTLE PREVIEW ABOUT TODAY LATER, BUT I'VE HAD THE OPPORTUNITY TO HAVE A DEEPER PREVIEW THAN PERHAPS WILL BE SHARED TODAY WITH YOU, AND I MUST SAY IT'S A VERY EXCITING EFFORT, AND ONE THAT WE WILL ALL BE VERY PROUD OF AND ONE THAT WILL GUIDE US. SO THANK YOU. I MEAN, THAT'S REALLY THE MAIN REASON TO BE HERE. NOW, AS YOU MIGHT MANL, A LOT OF IMAGINE, A LOT OF WHAT IS EMBEDDED WITHIN THAT DOCUMENT WILL BE ABOUT THE NEED FOR TEAMING, AND THE NEED FOR COLLABORATION. AND THE NEED FOR BRINGING TO BEAR ON THE MOST INTRACTABLE PROBLEMS, MULTI-AND INTERDISCIPLINARY APPROACH APPROACHES, AND THERE CAN BE NOTHING MORE IN NEED OF THAT THAN THIS EXTRAORDINARY EPIDEMIC THAT WE ARE SEEING IN THE COUNTRY RELATED TO OPIOID USE AND MISUSE. YOU'VE ALL SEEN THESE DATA IN DIFFERENT FORMS. WANTED TO DRAW YOUR ATTENTION TO THIS PARTICULAR ARTICLE THAT WAS PUBLISHED RECENTLY IN SCIENCE BECAUSE THEY LOOK AT THE DATA IN MANY, MANY DIFFERENT DIMENSIONS. YOU ACTUALLY HAVE TO GO TO THE WEBSITE TO SEE ALL THE DATA BECAUSE THEY JUST HAVE SORT OF PUBLISHED THIS ONE FIGURE AS THE PRINT JURNG, BUT IF YOU JOURNAL, BUT IF YO U GO INTO THE WEBSITE, EULG SEE THIS BY DRUG, BY AGE, BY TIME, BY EVERY WAY POSSIBLE AND IT'S REALLY RATHER INSTRUCTIVE, SO I WOULD CERTAINLY URGE YOU TO INTERROGATE THAT. NOW, AS YOU MIGHT IMAGINE, NIH'S CONTRIBUTION TO THIS CRISIS IS TO RESPOND WITH A RESEARCH AGENDA, AND AGAIN, AS YOU LIKELY WOULD SURMISE, THIS WOULD YOU INCLUDE TRYING TO FIGURE OUT SAFER AND MORE EFFECTIVE STRATEGIES TO MANAGE PAIN, BUT THEN, OF COURSE, TO DEAL WITH THE OPIOID ADDICTION TREATMENTS THEMSELVES AS WELL AS OVERDOSE REVERSAL, AND THERE ARE EXPERTS IN THE ROOM FROM BOTH NIDA AND NIAAA, SO IF YOU HAVE QUESTIONS ON THESE TOPICS, I WILL CERTAINLY DEFER TO THEM TO TELL YOU YOU MORE ABOUT IT. WE HAVE AN INITIATIVE TERMED "HEAL." THE ACRONYM COMES FROM THIS LONGER NAME, WHICH PROVIDES $500 MILLION A YEAR TO DO MANY OF THE THINGS THAT I POINTED TO IN THE PREVIOUS SLIDE. AND IN PARTICULAR, DEVELOP SHARED PLATFORMS THROUGH PUBLIC AND PRIVATE PARTNERS AND IMPORTANTLY, COORDINATING BOTH WITH THE SURGEON GENERAL AS WELL AS SISTER HHS AGENCIES AND LOCAL GOVERNMENT OFFICIALS. SO THIS REALLY IS A TEAM EFFORT, AND WITHOUT THAT, THERE'S REALLY LITTLE HOPE OF GETTING TRACTION ON THIS VERY IMPORTANT PROBLEM. JUST TO GIVE YOU ONE EXAMPLE, AND IT IS ONLY ONE OF MANY, MANY EXAMPLES, THERE IS THE ADVANCING CLINICAL TRIALS AND NEONATAL OPIOID WITHDRAWAL SYNDROME, ACT NOW PILOT STUDIES. THE NEONATAL RESEARCH NETWORK CENTERS IN THE DARKENED BOX OF THE COUNTRY ARE IN THE SORT OF PLACES YOU'D EXPECT THEM TO BE, WHERE THERE ARE MAJOR ACADEMIC HEALTH CENTERS, BUT, OF COURSE, CHILDREN IN MANY STATES, IN ALL STATES THROUGHOUT THE COUNTRY SUFFER FROM THIS, SO THE GROUP CAME UP WITH A VERY GOOD IDEA OF PARTNERING WITH THE IDEA STATES PEDIATRIC CLINICAL TRIALS NETWORK, WHICH IS THE PERFECT COMPLEMENT WHICH COVERS MANY OF THE AREAS OF THE COUNTRY THAT ARE NOT ENCOMPASSED BY THE NEONATAL RESEARCH CENTERS AND TAKEN TOGETHER, THEY ARE ABLE TO REALLY PROVIDE BETTER COVERAGE ACROSS THE NATION. SO THIS STARTED IN 2017, THERE ARE NOW 20 CLINICAL SITES PARTICIPATING AND THE INITIAL IDEA WAS TO ASSESS THE PREVALENCE OF -- THE DIFFERENT SITES AND TO REALLY CATALOG WHAT THE DIFFERENT APPROACHES ARE BECAUSE THERE IS NO ONE APPROACH TO THIS. WITH THE HOPE OF DEVELOPING COMMON PROTOCOLS FOR FUTURE STUDIES. AND THIS HAS NOW BEEN EXPANDED TO DETERMINE THE EFFECTIVENESS OF THE THINGS THAT ARE CURRENTLY USED TO TREAT WITHDRAWAL, TO COMPARE PHARMACOLOGICAL APPROACHES TO THE VARIOUS DRUG-FREE STRATEGIES WHICH ARE SOMETIMES KNOWN AS A EAT, SLEEP AND CONSOLE, AND THEN TO ASSESS THE IMPACT OF PRENATAL EXPOSURE TO OPIOIDS INCLUDING THE EFFECTS ON DEVELOPING BRAIN AND STRUCTURE AND FUNCTION, THE ISSUES RELATED TO HIGHER RISK FOR SCHOOL PERFORMANCE PROGRAMS, AND THEN WHAT HAPPENS LONG TERM, MEANING THESE KIDS WILL HAVE TO BE FOLLOWED TO ASCERTAIN IF THEY, IN FACT, HAVE A LONGER TERM RISK FOR ADDICTION. ULTIMATELY DETERMINE BEST PRACTICES BOTH FOR SHORT, MID AND LONG TERM OUTCOMES. ANOTHER VERY, VERY IMPORTANT INITIATIVE THAT I WANTED TO DRAW YOUR ATTENTION TO IS THE RECENT ANNOUNCEMENT ACTUALLY YET BY THE YESTERDAY ABOUT A NEW RENEWED EFFORT AT NIH TO BOTH PREVENT AND REDRESS HARASSMENT OF ALL TIMES BUT IN PARTICULAR, SEXUAL HARASSMENT. A NEW WEBSITE HAS BEEN PUT INTO PLACE WHERE -- IT'S A ONE-STOP PLACE, IF YOU WILL, FOR NIH STAFF, FOR AWARDEE ORGANIZATIONS,, WHERE ALL THE LAWS AND REGULATIONS ARE ENUMERATED, FREQUENTLY ASKED QUESTIONS AND IMPORTANT CONTACTS AND INFORMATION, BOTH FOR NIH EMPLOYEES AS WELL AS CONTRACTORS, AS WELL AS FELLOWS, AND VISITORS. SO THIS POLICY APPLIES TO EVERYBODY, NOT JUST THE FEDERAL WORKERS. WE ARE TAKING A VERY STRONG STANCE ABOUT THIS. IN FACT, LATER THIS WEEK, WE HAVE THE SO-CALLED NIH LEADERSHIP FORUM WHERE DR. COLLINS MEETS WITH ALL THE INSTITUTE CENTER DIRECTORS, DEP PEE DREP DREK DEPUTY DIRECTORS, FOR A VERY INTENSE DAY AND THREE QUARTERS, AND IN FACT THIS WHOLE ISSUE WILL BE A GOOD CHUNK OF ONE OF THOSE DAYS. SO THIS IS SOMETHING THAT EVERYBODY IS TAKING WITH THE UTMOST OF SERIOUSNESS. SO WITH THAT, I'VE GIVEN YOU BACK FOUR MINUTES, JANINE. I DON'T KNOW IF ANYBODY HAS A QUICK QUESTION, BUT IF NOT, I WILL JUST LET YOU PROCEED WITH YOUR AGENDA. >> ANY QUESTION FOR DR. TABAK? WE APPRECIATE YOUR ACCOMMODATING OUR SCHEDULE THIS MORNING. THANK YOU. >> YOU'RE MOST WELCOME. THANK YOU. [APPLAUSE] >> SO WE'RE GOING TO GO BACK TO OUR LOGISTICS. SO IF WE CAN GO BACK TO THE ST ECHT SLIDE. -- THE STE SLIDE. MS. SPENCER? >> THANK YOU. SO AS SPECIAL GOVERNMENT EMPLOYEES, JUST A REMINDER THAT THIS FEDERAL ADVISORY COMMITTEE YOU ARE SPECIAL GOVERNMENT EMPLOYEE, SGE AS WE AFFECTIONATELY CALL YOU, WHICH MEANS YOU'RE SUBJECT TO THE SAME ETHICS RULES THAT APPLY TO GOVERNMENT EMPLOYEES. THESE RULES ARE DESCRIBED IN THE PAMPHLET "STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE THE ECK IS EXECUTIVE BRANCH." AT EVERY MEETING WE LIKE TO REVIEW THE STEPS WE TAKE AND THE PROCESS WE FOLLOW TO IDENTIFY AND ADDRESS ANY CONFLICTS BETWEEN YOUR PUBLIC RESPONSIBILITIES AND YOUR PRIVATE INTERESTS. AS YOU KNOW, BEFORE EVERY MEETING, YOU PROVIDE US WITH A GREAT DEAL OF INFORMATION ABOUT YOUR PROFESSIONAL PERSONAL AND FINANCIAL INTERESTS. WE USE THIS INFORMATION AS THE FOUNDATION FOR ASSESSING WHETHER OR NOT YOU HAVE ANY REAL POTENTIAL OR APPARENT CONFLICTS OF INTEREST THAT COULD COMPROMISE YOUR ABILITY TO BE OBJECTIVE IN GIVING ADVICE DURING COMMITTEE MEETINGS. IF THE NEED FOR YOUR INDIVIDUAL SERVICES OUTWEIGHS THE POTENTIAL CONFLICT OF INTEREST, WE HAVE IDENTIFIED, WE WOULD ISSUE YOU A WAIVER OR RECUSE YOU FROM A PARTICULAR PORTION OF THE MEETING. WE USUALLY WAIVE CONFLICTS OF INTEREST FOR GENERAL MATTERS BECAUSE WE BELIEVE YOUR ABILITY TO BE OBJECTIVE WILL NOT BE AFFECTED BY YOUR FINANCAL INTERESTS. WE ALSO RELY A GREAT DEAL ON YOU AND YOU NEED TO BE ATTENTIVE DURING THE MEETING TO THE POSSIBILITY THAT AN ISSUE COULD ARISE THAT COULD AFFECT OR APPEAR TO AFFECT YOUR FINANCIAL INTEREST WITH A SPECIFIC PARTY OR MATTER. IF THIS HAPPENS, YOU WILL BE ASKED TO RECUSE YOURSELF FROM THAT PORTION OF THE THE MEETING. SO BEFORE WE GO ON ANY FURTHER, I WANTED TO SHARE AND REMIND YOU ALL THAT THE MINUTES FOR THE APRIL 18TH MEETING WERE POSTED ON THE ORWH WEBSITE AND A LINK WAS SENT TO YOU FOR REFERENCE. THE ADVISORY COMMITTEE NEEDS TO VOTE TO APPROVE THESE MINUTES FROM THE APRIL 2018 MEETING. TO MAKE A MOTION TO APPROVE? WE HAVE A MOTION TO APPROVE AND A SECOND. THE QUESTION ON THE TABLE, THEN, IS THAT WE APPROVE THE APRIL MINUTES. THOSE IN FAVOR OF THE MOTION, SAY AYE. NAYS? SO THE MOTION IS ADOPTED. THANK YOU ALL. THE MINUTES ARE APPROVED. AT THIS POINT, I'D LIKE TO RECOGNIZE. SO AS YOU KNOW, WE HAVE A NUMBER OF NEW MEMBERS THAT HAVE JOINED US. I'D LIKE TO RECOGNIZE DR. AMY PALLER, DR. LOUISE MCCULLOUGH AND DR. ANNA MARIA LANGER AS OUR NEWEST CRIT COMIT EE COMMITTEE MEMBERS. I'D ALSO LIKE TO THANK OUR RETIRING COMMITTEE MEMBERS AND THANK THEM ALL FOR THEIR SERVICE. THEY ARE DOCTORS NOEL BAIREY MERZ, DR. WEI-JUNG CHEN, DR. GEERT DEVRIES, DR. ANNE MARIA LOPEZ, DR. CAROL LIN -- I WILL NOW TURN THE MICROPHONE BACK OVER TO DR. CLAYTON. >> THANK YOU, MS. SPENCER. IT'S REALLY BEEN A PLEASURE TO GET TO KNOW ALL OF YOU AND I WANT TO ADD MY THANKS TO THOSE OUTGOING MEMBERS. WITHOUT FURTHER ADO, I'M GOING TO TRANSFER OVER TO THE PODIUM AND SHARE WITH YOU MY DIRECTOR'S REPORT. BEFORE I GET STARTED, I WANT TO RECOGNIZE SOME FOLKS IN THE ROOM. I'M DELIGHTED TO HAVE THE DIRECTOR OF NIDA AND REPRESENTATIVE -- SENIOR REPRESENTATIVES FROM NIMHD, FROM NLM, FROM NIDA AS WELL, CORA LEE, I SAW THERE, NIDDK, ELEANOR, NEI AS WELL, AND I ALSO WANT TO RECOGNIZE SOME OF OUR PARTNERS FROM ACROSS THE DEPARTMENT. WE'RE PLEASED TO HAVE PATTY TUCKER HERE FROM CDC, LIEUTENANT COLONEL KIM HOPKINS FROM THE UNITED STATES AIR FORCE, AS WELL AS BRIDGET NUGENT FROM THE OFFICE OF WOMEN'S HEALTH IF HE FDA. AT THE FDA. SO IS THIS ONE OF THE MOST FUN PARTS OF WHAT I GET DO, WHICH IS TO SHARE ALL THE AMAZING WORK THAT'S BEEN DONE BY INCREDIBLE GROUP OF INDIVIDUALS AND TEAM MEMBERS AT ORWH. I'D LIKE TO HIGHLIGHT TRANSITIONS IN LEADERSHIP HERE, ESPECIALLY TO HIGHLIGHT WOMEN IN LEADERSHIP POSITIONS. SO DR. JILL HEEMSKERK HAS BEEN SERVING AS THE ACTING DIRECTOR OF NIBIB FOR SOME TIME AND DR. BRUCE TROMBERG WILL BE JOINING NIH AS THE NEW DIRECTOR VERY SOON. AND DR. PATRICIA GRADY, AFTER MANY YEARS OF SERVICE, AS THE DIRECTOR OF THE NURSING INSTITUTE THE, HAS RETIRED, WELL DESERVED RETIREMENT, I HEAR SHE'S TRAVELING THE WORLD, SO WE MIGHT NOT BE ABLE TO GET IN TOUCH WITH HER, BUT WE ARE NOT LETTING HER GO ACTUALLY. AND ANNSCASHION SERVING AS ACTING DIRECTOR. DR. COLLINS ALSO SELECTED A NEW DIRECTOR FOR THE NATIONAL CENTER FOR COMPLEN MEN TRI AND INTEGRATIVE HEALTH. I HAD THE PLEASURE OF MEETING DR. LANGEVIN IN THE HALLWAY YESTERDAY. AT ALL OF MY TALKS I ALWAYS RECOGNIZE THE LEGACY OF ORWH BECAUSE I THINK IT'S CRITICALLY IMPORTANT TO REMEMBER HOW WE GET TO A PLACE, AND THE LATE DR. RUTH KIRSCHSTEIN AND DR. BERNADINE HEALY WERE TWO AMAZING LEADERS HERE AT NIH. AS YOU KNOW, DR. HEALY IS SO FAR THE ONLY WOMAN NIH DIRECTOR. AND OF COURSE DR. VIVIAN PINN, WHO YOU'LL SEE LATER TODAY. JUST BY WAY OF REMINDER, WE HAVE A VERY COMPREHENSIVE MISSION THAT COVERS EVERYTHING FROM BASIC SCIENCE TO CLINICAL RESEARCH, TO RECRUITMENT AND RETENTION TO SCIENCE POLICY. THIS IS TEAM ORWH AT OUR ANNUAL HEART TRUTH PHOTOGRAPH WHERE WE GET TO WEAR RED AND REPRESENT FOR WOMEN'S HEART HEALTH. THEY ARE AN AMAZING GROUP OF INDIVIDUALS AND NONE OF US WOULD BE HERE TO PRESENT ANY OF THIS FOR YOU TODAY WITHOUT THEIR WORK. AND DR. RAJEEV AGARWAL AND DR. LISA BEGG WERE REACCEPT RECIPIENTS OF 2018 NIH DIRECTOR'S AWARD. HERE'S MY OUTLINE FOR MY TALK TODAY. I'M GOING TO COVER SOME BRIEF UPDATES ON RESEARCH PROGRAMS, A LITTLE BIT ABOUT STRATEGIC VISION AND PLANNING, AN UPDATE ON SEX AS A BIOLOGICAL VARIABLE, BUILDING CONNECTIONS AND WOMEN IN BIOMEDICAL CAREERS. I WANT TO SHARE WITH YOU A FEW PIECES OF DATA THAT ARE VERY DISTURBING TO US. AS YOU KNOW, MATERNAL MORTALITY IS RISING IN THE UNITED STATES, AND THAT'S REALLY IN STARK CONTRAST TO THE FACT THAT IT IS DECREASING GLOBALLY. ESPECIALLY IN OUR PEER COUNTRIES. AND YOU CAN SEE HERE, THIS IS A PLACE WHERE YOU DO NOT WANT TO BE NUMBER ONE. THIS IS A BAD NUMBER ONE. IN FACT, OUR RATES OF MATERNAL MORTALITY EXCEED THOSE OF LIBYA, TURKEY AND VIETNAM. SO THERE'S MUCH WORK TO BE DONE IN THAT SPACE. WHAT ABOUT MORE BROADLY IN TERMS OF MEN AND WOMEN IN THE U.S. AND OUR LIFE EXPECTANCY? THIS WORK LOOKED AT LIFE EXPECTANCY AT BIRTH, ZERO TO 65 AND OVER 65, AND THE U.S. IS IN PURPLE -- I MEAN KIND OF FUCHSIA THERE AT THE BOTTOM, AND YOU CAN SEE FOR WOMEN ON THE LEFT AND MEN ON THE RIGHT, THE U.S. IS AT THE BOTTOM. IN EACH CASE. THE GAP IS SIGNIFICANT FOR BOTH MEN AND WOMEN. THE WORLD LEADER IS FAR ABOVE, AND ACTUALLY THIS INFORMATION ALSO AS I MENTIONED LOOKED AT LIFE EXPECTANCY CHANGES IN YOUNGER PEOPLE, ZERO TO 65. AND IT WAS PREMATURE DEATH IN THAT AGE RANGE THAT REALLY MADE THE U.S. STAND OUT. SO THESE ARE NOT THE DEATHS YOU WOULD EXPECT TO BE SEEING. WHY MIGHT THAT BE? WELL, THEY POSIT THAT THE OPIOID CRISIS AND OTHER EXTERNAL CAUSES, SO CALLED DEATHS OF DESPAIR, ARE CONTRIBUTING SIGNIFICANTLY TO THIS IN THE UNITED STATES, AND YOU CAN SEE OUR STANDARD DAILY DOSES OF PRESCRIPTION OPIOIDS PER MILLION INHAS BEEN TANTS. WE ARE, AGAIN, A BAD NUMBER ONE. SO MUCH WORK REMAINS TO BE DONE THERE. AND WE THINK THAT MANAGING THIS PARTICULAR CRISIS WHICH IS REALLY UNPRECEDENTED REQUIRES PRIORITIZATION OF CONSIDERING SEX AND GENDER DIFFERENCES AND IN FACT THE NIDA WEBSITE PROMINENTLY DISPLAYS THIS INFORMATION WITH DISAGGREGATED INFORMATION AND DATA, AND I'LL JUST HIGHLIGHT ONE OF THE PIECES OF INFORMATION WHICH IS ALSO LINKED TO SAMHSA'S WEBSITE, THE NUMBER OF WOMEN WITH OPIOID USE DISORDER AT LABOR AND DELIVERY HAS QUADRUPLED IN THE LAST 15 YEARS. OUR OWN DR. CAROLYN MAZURE AND CO-AUTHOR DAVID FIELLIN RECENTLY PUBLISHED IN LANCET A PIECE, "WOMEN AND OPIOIDS: SOMETHING DIFFERENT IS HAPPENING HERE." THEY HIGHLIGHT THAT HALTING THIS MOMENTUM AND EFFECTIVELY MANAGING THE SEQUELAE OF THIS OPIOID EPIDEMIC REQUIRES RESEARCH, CLINICAL AND POLICY COMMITMENTS TO UNDERSTANDING THE INFLUENCES OF GENDER IN THIS PARTICULAR SPACE. AND YOU HEARD FROM DR. TABAK ABOUT NIH'S INITIATIVE, THE HEAL INITIATIVE, TO ADDRESS THESE ISSUES. THE HEAL INITIATIVE AS YOU HEARD COMES IN TWO MAJOR PIECES. THE FIRST IS A RESEARCH PLAN DESIGNED TO ADDRESS IMPROVING TREATMENTS FOR OPIOID MISUSE AND ADDICTION AND A COMPLEMENTARY EFFORT TO ENHANCE PAIN MANAGEMENT, OBVIOUSLY A RELATED ISSUE. AND I WANT TO HIGHLIGHT FOR YOU AN EXAMPLE OF HOW ORWH HAS BEEN WORKING WITH OUR INSTITUTE AND CENTER COLLEAGUES TO ENSURE THAT SEX AS A BIOLOGICAL VARIABLE IS CONSIDERED IN THE CONTEXT OF THE HEAL INITIATIVE. FOR EXAMPLE, IN THIS FOA, WHICH IS AN ADMINISTRATIONTIVE SUPPLEMENT FOR VALIDATION OF NOVEL NON-ADDICTIVE PAIN TARGETS, SPECIFICALLY THE FOA STATES, BECAUSE OF OUR INVOLVEMENT, INCLUSION OF THE DESCRIPTION OF SABAV IS NAWL VALIDATION EXPERIMENTS IS ENCOURAGED AND WE ARE EXCITED ABOUT THAT. I'D ALSO LIKE TO REPORT TO YOU THAT WE'VE BEEN WORKING WITH OUR FDA PARTNERS IN THIS MEETING THAT WAS LED BY THE OFFICE OF WOMEN'S HEALTH AT THE FDA ALONG WITH SEE DER AND THE CENTER FOR TOBACCO PRODUCTS VERY RECENTLY ON OPIOID AND NICOTINE USE, DEPENDENCE AND RECOVERY, INFLUENCES OF SEX AND GENDER, A FIRST MEETING EVER OF ITS KIND AT THE FDA. AND DR. MARJORIE JENKINS PICTURED ON YOUR RIGHT WAS THE LEAD FOR THIS EFFORT AT THE FDA'S OFFICE OF WOMEN'S HEALTH WHICH FEATURED A KEYNOTE THE FROM REAR ADMIRAL SYLVIA ADAMS, THE DEPUTY SURGEON GENERAL, AS WELL AS A VARIETY OF OTHER TALKS. YOU CAN SEE THIS ON THE WEBCAST WHICH THE URLs ARE DISPLAYED FOR YOU AT THE BOTTOM OF THE SLIDE. AND JUST LAST WEEK, WE HAD ANOTHER NIH CONFERENCE AROUND SLEEP, A VERY IMPORTANT CROSS CUTTING FOUNDATIONAL ISSUE. WHERE WE SOUNDED THE WAKEUP CALL FOR THE IMPORTANCE OF SLEEP TO THE HEALTH OF WOMEN. SLEEP IS LINKED TO SO MANY OTHER ASPECTS OF THE HEALTH OF WOMEN. AND SLEEP IN THE HEALTH OF WOMEN, THE 2018 RESEARCH CONFERENCE, WAS LED BY THE TRANS-NIH SLEEP RESEARCH COORDINATING COMMITTEE MANAGED OUT OF THE NATIONAL HEART, LUNG AND BLOOD INSTITUTE WITH COLLABORATION FROM THE DEPARTMENT'S OFFICE OF WOMEN'S HEALTH, ORWH AND OTHERS, AND THE KEYNOTE SPEAKERS WERE QUITE INCREDIBLE. MISS STACEY STEWART HIGHLIGHTED THE MARCH OF DIMES NEW EFFORT LOOKING AT MATERNAL MORTALITY ENTITLED "BLANKET CHANGE." INSTEAD OF INSTRUMENTAL CHANGE, THEY'RE CALLING FOR BLANKET CHANGE. RECENTLY AS WELL, ORWH HAS BEEN SERVING ON THE TASK FORCE ON RESEARCH SPECIFIC TO PREG NANTD PREGNANT AND LACTATING WOMEN. THE FINAL REPORT RECEIVED BY CONGRESS IN SEPTEMBER OF THIS YEAR. I HIGHLIGHT FOR YOU ON THE LEFT FROM A PUBLICATION BY DRS. SPONG AND BIANCHI THAT PREGNANCY AND LACTATION IS AN EXCLUSION CRITERION FOR MANY CURRENTLY RECRUITING NIH PHASE 3 AND PHASE 4 STUDIES. SO THAT IS AN ISSUE BECAUSE WE'RE EXCLUDING PREGNANT AND LACTATING WOMEN WITHOUT A WAY OF ADDRESSING THE ISSUES OF PREGNANT AND LACK TAIGHT WOMEN. LACTATING WOMEN. THE MEMBERSHIP IS HIGHLIGHTED HERE. THIS TASK FORCE RELEASED 11 RECOMMENDATIONS. I SHOW YOU THE FIRST FOUR HERE. I'M GOING TO HIGHLIGHT THE FIRST ONE WHICH TO ME IS THE MOST ESSENTIAL -- YOU CAN SEE THE FULL REPORT OF THE PREGLAC AT THE NICHD WEBSITE. DR. RODGERS, THE DIRECTOR OF THE NATIONAL INSTITUTE OF DIABETES DIGESTIVE AND KIDNEY DISEASES AND THEY PUT OUT RECENT ADVANCES IN -- EVERY YEAR WHERE THEY HIGHLIGHT THE ADVANCES THAT THEY HAVE SUPPORTED AND IT'S BEEN OUR PLEASURE TO WORK WITH THEM ON CROSS CUTTING TOPICS, ON ISSUES RELATED TO OBESITY, DIGESTIVE DISEASES AND NUTRITION, KIDNEY, UROLOGIC AND HEMATOLOGIC DISEASES AS WELL AS DIABETES, ENDOCRINOLOGY AND METABOLIC DIABETES. SO YOU'LL HEAR FROM HIM SHORTLY ON GESTATIONAL AND TYPE 2 DIABETES IN WOMEN AND GIRLS. CHALLENGES, PROGRESS AND THE PATHS FORWARD. AS YOU KNOW, WE SUPPORT A VARIETY OF WOMEN'S HEALTH RESEARCH EFFORTS ACROSS NIH WITH THE 27 INSTITUTES AND CENTERS THROUGH A VARIETY OF COFUNDING PROGRAMS AND MECHANISMS. TODAY I'M JUST GOING TO MENTION A BRIEF UPDATE ABOUT ONE OF THEM. THE U3 PROGRAM FOCUSES ON UNDERSTUDIED, UNDERREPORTED AND UNDERREPRESENTED POPULATIONS OF WOMEN. OFTEN AT THE CONFLUENCE OF SEX, GENDER AND RACE/ETHNICITY ALONG WITH OTHER SOCIAL DETERMINANTS OF HEALTH. IT IS A ONE-YEAR ADMINISTRATIVE SUPPLEMENT AND IN FY18, I'M PLEASED TO TELL YOU THAT 17 ICs SIGNED ON TO THIS FOA INCREASING FROM LAST YEAR. SO JUST THE SECOND YEAR OF OUR FUNDING OPPORTUNITY, WE NEARLY DOUBLED OUR COMMITMENT AND ADDRESSED A BROADER RANGE OF SIGH EBBS. HERE'S SCIENCE. HERE'S AN EXAMPLE FROM THE PILOT SHARED DECISION-MAKING INTERVENTION FOR DIABETES PREVENTION IN HIGH RISK WOMEN WITH GDM, HIGHLY RELATED TO THE DIABETES IPP. IN TERMS OF NEW NEWS, US A HEARD FROM DR. TABAK, WE ARE PREVIEWING FOR YOU TODAY THE IMPORTANT AND KEY ELEMENTS OF A NEW STRATEGIC PLAN. THIS TRANS-NIH STRATEGIC PLAN WILL BE A ROAD MAP FOR ACTUALIZING THE NIH VISION FOR WOMEN'S HEALTH RESEARCH AND WOMEN IN SCIENCE CAREERS, AND WE'VE BEEN BUSY WITH THINK TANKS ACROSS NIH AND MEETING WITH OTHERS. WE INTEND FOR THE ADVANCING SCIENCE FOR THE HEALTH OF WOMEN TO INTEGRATE THE MISSION OF ORWH WITH THE MISSIONS OF ALL THE INSTITUTES AND CENTERS, ADVANCING A VISION WHERE SEX AND GENDER INFLUENCES ARE FULLY INTEGRATED INTO THE BIOMEDICAL RESEARCH ENTERPRISE,EVERY WOMAN RECEIVED TREATMENT TAILORED TO HER OWN NEEDS, CIRCUMSTANCES AND GOALS. AND WOMEN IN SCIENCE CAREER REACH THEIR FULL POTENTIAL. AND SO I AM ALSO EXCITED TO SHARE WITH YOU THAT I WANT TO GIVE SPECIAL THANKS TO TWO MEMBERS OF ORWH WHO HAVE BEEN LEADING THE STRATEGIC PLANNING EFFORT ON BEHALF OF ORWH. LATER TODAY, YOU WILL ALSO HEAR FROM TWO AMAZING WOMEN LEADERS, FORMER REPRESENTATIVE AND AMBASSADOR CONNIE MORELLA WILL BE HERE AND ALSO FORMER SENATOR BARBARA MIKULSKY WILL BE HERE, SO PLEASE STAY WITH US FOR THIS AFTERNOON. VERY BRIEFLY, I CAN'T GO WITHOUT MENTIONING THE SEX AS A BIOLOGICAL VARIABLE POLICY WHICH US A KNOW WENT INTO EFFECT SOME TIME AGO, SO IN A NUTSHELL, THAT POLICY STATES THAT NIH EXPECTS THAT SEX AS A BIOLOGICAL VARIABLE WILL BE FACTORED IN TO RESEARCH DESIGNS , ANALYSES AND REPORTING IN VERTEBRATE ANIMAL AND HUMAN STUDIES. AND WE CONTINUE TO SPEARHEAD DISSEMINATION AROUND SABV. FOR EAMPLE, THROUGH OUR WOMEN'S HEALTH RESEARCH SEMINAR SERIES, AND YOU YOU CAN SEE OUR DISTINGUISHED SPEAKERS, DR. SABRA KLEIN AND DR. LANGER, AS WELL AS OTHER DISTINGUISHED SCIENTISTS. UPCOMING DECEMBER 6TH, WE HAVE ANOTHER SPEAKER ON DECEMBER 6TH, DR. NADIA DOWSHEN, AND WE ALSO HAVE DEVELOPED A NEW SEX AND GENDER SCIENTIFIC INTEREST GROUP HERE AT NIH, AND WE HAVE HAD TALKS RANGING FROM SEX DIFFERENCES IN EPIGENETICS, TO SEX DIFFERENCES IN BRAIN IMAGING, TO CONNECTIONS BETWEEN SLEEP AND GENE NETWORKS IN DROSOPHILA. OUR NEXT TALK WILL BE ON NOVEMBER 20TH, TISH MURPHY FROM THE INTRAMURAL PROGRAM WILL BE SPEAKING. I ALSO WANT TO ACKNOWLEDGE IN A VERY SPECIAL WAY MY AMAZING LEADERSHIP TEAM, THE ASSOCIATE DIRECTORS IN ORWH, DR. VICTORIA CARGILL, DR. SAMIA NOURSI, DR. MARGARET BEVANS AND DR. SHARON HUNTER CHYREN HUNTER. I HIGHLIGHT FOR YOU JUST ONE OF THE TALKS THEY'VE DONE TO REPRESENT ORWH AND TO DISSEMINATE SABV AND OUR MISSION. WE HAVE AN EXCITING UPDATE FOR YOU ON OUR NEW ONLINE COURSE ON SEX AND GENDER INFLUENCES IN DISEASES AND CONDITIONS AFFECTING WOMEN. THIS IS A PARTNERSHIP WITH THE OFFICE OF WOMEN'S HEALTH AT THE FDA. WE HAVE CO-DIRECTORS FROM ORWH AND OWH AT FDA LEADING THIS EFFORT. THE FIRST MODULE, WE ARE CURRENTLY WAY TA TESTING SO WE'RE VERY EXCITED ABOUT THAT. BETA TESTING. I'M EQUALLY EXCITED TO SHARE WITH YOU THAT THAT WE CO-SPONSORED A MEETING WITH THE AMERICAN DENTAL ASSOCIATION ON WOMEN'S HEALTH IN INTERPROFESSIONAL EDUCATION AND COLLABORATIVE CARE. WE THINK THAT INTERPROFESSIONAL EDUCATION ACROSS ALL HEALTH PROFESSIONALS CAN HELP CATALYZE AN INTEGRATIVE APPROACH TO MEDICINE AND TO NURSING AND TO PHARMACY AND TO ALLIED HEALTH, WHERE WE CAN TRAIN A GENERATION OF NEW HEALTHCARE PROFESSIONALS FOR WHOM SEX AND GENDER IS A GIVEN. IF THEY'RE TRAINED THAT WAY FROM THE BEGINNING, WE THINK THAT WE CAN REALLY MAKE A BIG DIFFERENCE. LOOKING AT THE INTERSECTION OF SEX, GENDER, RACE/ETHNICITY AND AGE, WE SEE AS AN ORGANIZING PRINCIPLE FOR INTEGRATING INTERPROFESSIONAL EDUCATION. WE'VE ALSO BEEN BUSY BUILDING CONNECTIONS AND GETTING THE WORD OUT BROADLY TO AS MANY OF OUR STAKEHOLDERS AS POSSIBLE, AND ONE WAY IS THROUGH DISSEMINATING INFORMATION TO THE PUBLIC. IT'S BEEN REALLY EXCITING TO BE ABLE TO SHARE THAT ACROSS THE BOARD, RANGING FROM PIECES ON THE "TODAY" SHOW ON WOMEN AND WELLNESS, WHETHER THERE'S A GENDER BIAS IN HEALTHCARE, TO A MORE RECENT PIECE IN THE "WASHINGTON POST" ABOUT WHY WOMEN HAVE MORE MIGRAINES THAN MEN DO. AND BARBARA STREISAND WAS THE NIH'S ANNUAL J. EDWARD RALL CULTURAL LECTURER THIS PAST YEAR, WHERE SHE MADE IT VERY CLEAR THAT SHE TAKES WOMEN'S HEALTH TO HEART AND SHE HAD A FIRE SIDE CHAT STYLE DISCUSSION WITH DR. COLLINS, AND SHE REALLY PUT FORWARD IN A VERY ELOQUENT WAY BETTER UNDERSTANDING OF SEX DIFFERENCES WILL NOT ONLY FILL CRITICAL GAPS IN WOMEN'S HEALTH BUT CAN IMPROVE MEN'S HEALTH AS WELL, AND THAT VIDEOCAST IS AVAILABLE FOR YOUR REVIEW. TEAM ORWH HAS BEEN BUSY WRITING SCIENTIFIC PUBLICATIONS. HERE ARE SOME OF THE MANUSCRIPTS FROM THE OFFICE. AND ONE THAT IS MOST RECENT, I WANT TO BRING TO YOUR ATTENTION, VERY RECENTLY ALONG WITH DEPUTY DIRECTOR OF EXTRAMURAL RESEARCH, MIKE LAWYER, AND THE DEPUTY DIRECTOR OF THE AGING INS INSTITUTE, MARIE BERNARD. I WAS PLEASED TO PARTICIPATE IN THIS JAMA PUBLICATION UPDATING ON EVERYONE IN THE NEW INCLUSION ACROSS THE LIFETIME POLICY AND EXPANSION WHICH NOW CALLS FOR INCLUSION OF INDIVIDUALS OF ALL AGES ACROSS THE BOARD IN CLINICAL RESEARCH, SUPPORTED BY NIH. AND I'M VERY PROUD TO SAY THAT EVEN THOUGH THIS HAS BEEN OUT FOR JUST A BIT, WE'VE ALREADY HAD NEARLY 4500 VIEWS FOR THIS PIECE. I'M ALSO EXCITED TO SHARE WITH YOU THAT THE FALL ISSUE OF THE ORWH NEWSLETTER WHICH IS ENTITLED "WOMEN'S HEALTH IN FOCUS," HIGHLIGHTING THE TRANS-NIH NATURE OF WOMEN'S HEALTH RESEARCH AND THE INSTITUTE AND CENTER EFFORTS WITH A FOCUS THIS TEAM ON CAREERS AS WELL AS SOME SCIENCE ADVANCES WILL BE AVAILABLE HERE FOR YOU LATER TODAY. AND LAST BUT CERTAINLY NOT LEAST, WOMEN IN BIOMEDICAL CAREERS. OUR ANNUAL BIRCH MEETING WILL BE HEALTH ON NOVEMBER 28TH SO PLEASE MART YOUR CALENDARS. THE BIRCWH PROGRAM IS DESIGNED TO EXPAND THE CADRE OF WOMEN'S HEALTH RESEARCHERS, BOTH MEN AND WOMEN, AND WE'RE DELIGHTED THAT WE WILL BE HOSTING THE INAUGURAL RUTH L. KIRSTEIN TALK. DR. GUISE HAS BEEN SELECTED AS THE FIRST MEMORIAL LECTURER. I BRING INFORMATION ALSO FROM THE NIGMS DEPUTY DIRECTOR DR. JUDITH GREENBERG, TOOK A QUESTION AND FURTHER INVESTIGATED IT, AND SHE AND HER NIGMS COLLEAGUES RECENTLY PUBLISHED IN PNAS A PAPER LOOKING AT LONGEVITY OF NIH FUNDING BY GENDER. WHAT SHE FOUND WAS FIRST NIH RECEIVES FEWER THAN A THIRD OF OUR NEW GRANT APPLICATIONS FROM WOMEN, SO JUST FROM THE BEGINNING, FEWER THAN A THIRD OF THOSE ARE COMING FROM WOMEN. BUT WHEN WOMEN APPLY, FOR FIRST TIME GRANTS, THEY ARE AS SUCCESSFUL AS MEN ARE. IF YOU LOOK AT LONGEVITY OF FUNDING, ONCE THEY ARE FUNDED BY NIH, HOW LONG DO THEY MAINTAIN THEIR NIH FUNDING, THERE'S A VERY SMALL DIFFERENCE WITH WOMEN HAVING A SLIGHTLY, ONLY SLIGHTLY SMALLER FUNDING LONGEVITY THAN SUSTAINING NIH FUNDING MAY BE BETTER THAN IS COMMONLY PERCEIVED IN THE COMMUNITY, AND THAT'S WHERE WE WANT YOU TO HEMIUSHELP US GET OUT. WE ALSO THINK THAT MEANS STRATEGIES TO ADDRESS THIS GENDER DISPARITY AMONG PEOPLE HOLDING ACADEMIC POSITIONS WHO WOULD BE POTENTIAL PRINCIPAL INVESTIGATORS SHOULD FOCUS ON THAT UNDERREPRESENTATION OF WOMEN AMONG THE INITIAL POOL OF NIH GRANTEES AND THEIR LOWER RATES OF BOTH NEW AND RENEWAL SUBMISSIONS. WOMEN ARE RES LIKELY TO COME LESS LIKELY T O COME IN FOR FUNDING SUBSEQUENTLY AS WELL. WE HAVE EXCITING NEWS ON THIS OTHER FRONT. WE'VE COMMISSIONED A NEW NATIONAL ACADEMY STUDY OF WHY WOMEN ARE UNDERREPRESENTED IN STEM INCLUDING MEDICINE AND MATHEMATICS HERE, DISCIPLINES AT PIVOTAL CAREER STAGES. WE JUST TALKED ABOUT A PIVOTAL CAREER STAGE, GETTING OUR FIRST R01. THE LANDMARK STUDY, "BEYOND BIAS AND BARRIERS" WAS TROA DUED 10 YEARS AGO, HOW WELL WE HAVE DONE AT IMPLEMENTING THE INTERVENTIONS. WE KNOW THERE'S A PROBLEM, WE'VE STUDIED THE PROBLEM, WE WANT TO UNDERSTAND WHY THE INTERVENTIONS HAVE WORKED SOME PLACES, WHY THEY HAVE BEEN ADOPTED SOME PLACES AND NOT OTHERS, WHY SOME MAY WORK IN CERTAIN CIRCUMSTANCES, SYNTHESIZE THAT INFORMATION ON CURRENT RESEARCH ON WHAT IS EFFECTIVE, EXAMINE HOW THOSE INTERVENTIONS HAVE INFLUENCED REPRESENTATION OF WOMEN BY DIFFERENT SCIENTIFIC DISCIPLINES FROM MEDICINE TO OUR PH.D. COLLEAGUES ACROSS DIFFERENT STAGES, AND CONSIDERED WHY CERTAIN DISCIPLINES IN PARTICULAR HAVE MADE LESS PROGRESS. IT'S DISTURBING TO HEAR THAT THE NUMBER OF WOMEN PURSUING A COMPUTER SCIENCE UNDERGRADUATE DEGREE HAS ACTUALLY DECREASED STEADILY FOR THE PAST FEW YEARS. SO WE WILL LOOK FORWARD TO THIS NATIONAL ACADEMY STUDY AND I WANT TO FLAG FOR YOU SEPTEMBER OF NEXT YEAR AND MARCH OF 2020 FOR CONFERENCES THAT WILL FOLLOW UP FROM THIS STUDY. I AM PARTICULARLY EXCITED TO SHARE WITH YOU THAT ORWH HAS DEVELOPED ITS NEW SCIENCE POLICY SCHOLAR TRAVEL AWARD THAT WILL BE GIVEN FOR THE OSSD, THE ORGANIZATION FOR THE STUDY OF SEX DIFFERENCES MEETING THIS YEAR, AND THE MEETING IS IN WASHINGTON, D.C. THIS YEAR. THE DEADLINE FOR APPLICANTS IS DECEMBER 1ST, SO IT IS A TRAVEL AWARD SO IF YOU KNOW OF INDIVIDUAL, WE'RE PARTICULARLY LOOKIG AT JUNIOR INVESTIGATORS FOCUSING ON SEX AND GENDER DIFFERENCES WHO ALSO HAVE AN INTEREST IN POLICY. IS THAT A FIRE DRILL? [A FIRE ALARM HAS BEEN REPORTED. >> LAST SLIDE AND WE'LL GO TO OUR -- THE VIVIAN PINN SYMPOSIUM WAS HELD EARLIER THIS YEAR FOCUSING ON CATALYTIC CONNECTIONS, LEVERAGING THE NETWORK TO ADVANCE WOMEN IN SCIENCE, AND I NEED YOU TO PUT THIS DATE ON YOUR CALENDAR. MAY 15TH, 2019, THE 2018 VIVIAN PINN SYMPOSIUM WILL BE FOCUSED ON IMPROVING MATERNAL HEALTH. SO FOLKS ON THE WEBCAST, WE'RE GOING TO NEED TO EXIT THE PREMISES FOR THE FIRE ALARM -- WE DON'T? OKAY. WE'RE GOING TO CHECK WHETHER THIS IS A DRILL OR WE REALLY DO NEED TO EXIT THE ROOM. IN THE MEANWHILE, I'LL GO AHEAD AND GIVE YOU THE SOCIAL MEDIA INFORMATION A TRANSITION HERE TO OUR NEXT TALK. >> I'D LIKE TO RE-INTRODUCE DR. GRIFFIN RODGERS. >> THANK YOU SO MUCH FOR INVITING ME TO THIS, AND BELIEVE ME, IT WAS NOT MY INTENT TO HAVE SUCH A DRAMATIC OPENING. PERHAPS MEMORABLE, MAYBE NOT, BUT IT'S DEFINITELY A PLEASURE AND A PRIVILEGE TO SPEAK TODAY ON WHAT I THINK IS A PRETTY AUSPICIOUS DAY WHEN THE OFFICE OF RESEARCH ON WOMEN'S A HEALTH WILL BE LAUNCHING THEIR FIVE-YEAR STRATEGIC PLAN FOR WOMEN'S HEALTH RESEARCH, I WANT TO CON LATE DR. JANINE CLAYTON AND HER STAFF FOR ALL THE WORK THAT THEY'VE DONE AND THE COMMITTEE FOR YOUR VISION AND LEADERSHIP IN PUTTING THIS TOGETHER WITH INPUT OBVIOUSLY FROM THE PUBLIC AND ACROSS NIH, AND I'M GOING TO SORT OF REVERSE PRIVILEGE HERE AND MAYBE GIVE YOUR STAFF A ROUND OF APPLAUSE. WELL DESERVED. [APPLAUSE] AND WITHOUT STEALING SOME OF THEIR THUNDER, I REALLY HOPE THAT MY PRESENTATION HERE WILL SORT OF BE A PROLOGUE OF WHAT YOU'RE GOING TO HEAR THIS AFTERNOON, WHEN SOME OF THE PRINCIPALS IN THE OVERAMPING DESIGN OF THIS FIVE-YEAR STRATEGIC PLAN WILL BE PRESENTED TO YOU. NOW, AS DR. CLAYTON MENTIONED, NIDDK AND ORWH HAVE REALLY BEEN GREAT PARTNERS OVER THE YEARS BECAUSE OF SOME OF OUR OVERLAP OVERLAPPING AREAS OF GREAT INTEREST. WE HAVE DISEASES AND CONDITIONS IN NIDDK THAT SPECIFICALLY AND PREDOMINANTLY AFFECT WOMEN SUCH AS GESTATIONAL DIABETES, AND PELVIC AND VISCERAL PAIN LIKE INTERSTITIAL CYSTITIS AND IRRITABLE BOWEL SYNDROME. TYPE 1, TYPE 2 DIABETES, CERTAIN KIDNEY DISEASES AND PARTICULARLY DISEASES OF THE LIVER. AND AS A DIRECT RESULT OF THAT OVER THE YEARS, WE REALLY HAD A VERY LONG HISTORY OF A ROBUST COLLABORATION IN THIS AREA. OF COURSE AS YOU ALL ARE ON COUNCIL, YOU KNOW THAT EVERYTHING THAT WE DO IN THE FEDERAL SYSTEM HAS TO HAVE AN ACRONYM, AND YOU CAN SEE THAT THIS SLIDE IS FILLED WITH A NUMBER OF THESE ACRONYMS. OF THE MAJOR STUDIES ANDS SOME- ACTIVITIES IN WHICH NIDDK HAS PARTICULARLY PARTICIPATED IN WITH ORWH AND PARTNERED OVER THE YEARS TO ADVANCE THE HEALTH OF WOMEN AND AN UNDERSTANDING OF SEX AS A BIOLOGICAL VARIABLE. I THINK WITH GREAT SUCCESS. AND ORWH HAS ALSO HELPED TO FOSTER INVESTIGATOR INITIATED RESEARCH IN A VARIETY OF FIELDS IN BOTH COMMON INTEREST, CONTINUING THROUGH SOME OF THESE SPECIALIZED CENTERS THAT HAVE BEEN AND WILL CONTINUE TO BE FUNDED BY ORWH. IT ALSO HELPED US WITH PROGRAMS LIKE REAP AND THE ANSWER PROGRAM, AS WELL AS SOME OF OUR R56 PROGRAMS. SO ORWH AND NIDDK HAVE REALLY BEEN GREAT PARTNERS OVER THE YEARS AND I SUSPECT WE WILL CONTINUE TO BE FOR THE BRIGHT FUTURE. SO THE ENG. WHAT CHAT ENG. I'D LIKE TO REALLY FOCUS ON DIABETES BECAUSE OF THE IMPORTANCE OF DIABETES AND STARTING WITH SOME OF THE CHALLENGES THAT WE'RE GRAPPLING WITH, WITH HAD AS A DISEASE, ESPECIALLY AS IT AFFECTS WOMEN AND GIRLS. AS A QUICK REMINDER AS YOU KNOW, DIABETES EXISTS IN INDIVIDUALS WHEN THE BODY'S ABILITY TO PRODUCE OR RESPOND TO THE HORMONE INSULIN IS IMPAIRED, AND THESE DEFECTS LEAD TO A PERSISTENT ELEVATION IN BLOOD GLUCOSE, OTHER ASSOCIATED METABOLIC DERANGEMENTS AND OVER TIME, THESE LEAD TO A SERIES OF COMPLICATIONS INCLUDING BLINDNESS AND KIDNEY DISEASE AND NEWER ROPATHY, NE NEWER NEUROPATHY. COMPLICATIONS ALONE AT THE MOST RECENT ESTIMATE BY THE AMERICAN DIABETES ASSOCIATION COMES IN SOMEWHERE AROUND $325 BILLION PER YEAR, AND THAT'S ONLY FOR PEOPLE WHO ARE DIAGNOSED WITH DIABETES. AND AS I'LL SHOW YOU IN A MOMENT, THAT'S REALLY ONLY THE TIP OF THE ICEBERG. IN FACT, I'LL SHOW YOU NOW. THIS SLIDE REALLY SHOWS -- REALLY GIVES YOU A GOOD SENSE OF THAT IN TERMS OF IN THE U.S., SLIGHTLY OVER 30 MILLION PEOPLE ARE AFFECTED WITH DIABETES, INCLUDING 23 MILLION WHO ARE DIAGNOSED. AND UPON THIS NUMBER, THE DISTRIBUTION IN TERMS OF THE GENDER ARE ROUGHLY EQUIVALENT. IT'S ABOUT 11.4 VERSUS 11.7 IN MEN AND WOMEN IN TERMS OF DIAGNOSED CASES. IT IS CONSIDERED THAT THERE ARE PERHAPS MORE MEN WHO ARE UNDIAGNOSEED COMPARED TO WOMEN BECAUSE WOMEN HAVE OFTEN THE OPPORTUNITY TO HAVE MORE FOLLOW-UP OR AT LEAST THEIR CONTACTS WITH THE HEALTHCARE SYSTEM MAY BE SOMEWHAT GREATER. BUT AGAIN, THIS IS JUST THE TIP OF THE ICEBERG. JUST BELOW THAT ARE A NUMBER OF 84 MILLION U.S. AMERICANS WHO HAVE PRE-DIABETES, MEANING THAT THEIR BLOOD SUGARS AREN'T QUITE HIGH ENOUGH YET TO CLASSIFY THEM AS NOT BEING DIABETIC, BUT IT'S CERTAINLY MUCH HIGHER THAN NORMAL. AND OF THESE, WELL OVER 80% OR MORE ARE COMPLETELY UNAWARE THAT THEY HAVE THIS CONDITION. THIS IS UNFORTUNATE BECAUSE EVEN HAVING PRE-DIABETES INCREASES YOUR RISK FOR CARDIOVASCULAR DISEASE AND OTHER COMPLICATIONS. AND HERE AGAIN IN TERMS OF THE GENDER DIFFERENCES, MEN TEND TO BE MUCH GREATER IN TERMS OF THOSE WHO ARE UNDIAGNOSED WITH PRE-DIABETES. THISTO DELVE INTO THAT A LITTLE MORE IN TERMS OF RACE AND ETHNICITY, YOU CAN SEE WHEN WE GET THIS OVERALL AVERAGE OF PEOPLE BETWEEN 18 AND OLDER, YOU CAN SEE THAT ALASKA -- AMERICAN YAINDS AND ALASKA NATIVES TEND TO HAVE THE HIGHEST PREVALENCE FOLLOWED BY NON-HISPANIC BLACKS AND HISPANIC POPULATION. ASIAN AMERICANS TEND TO BE LOWER BUT THIS IS A CIRCUMSTANCE THAT I'LL TELL YOU IN A MOMENT BECAUSE THEY TEND TO DEVELOP DIABETES AT A LOWER BMI, A GREATER NUMB WE ARE OF THEM ARE UNDIAGNOSED WITH THE CONDITION. AND YOU CAN SEE THE GENDER DIFFERENCES ARE ROUGHLY EQUIVALENT ACROSS THOSE GROUPS. AGAIN BEFORE GOING ON, JUST TO TARGET IN A LITTLE BIT MORE ON THE THREE MAJOR TYPES OF DIABETES, TYPE 1 OF COURSE IS A MISGUIDED AUTOIMMUNE ATTACK THAT DESTROYS THE INSULIN-PRODUCING BETA CELLS. THIS ACCOUNTS FOR ABOUT 5% OF THAT 30 MILLION THAT I JUST SHOWED YOU, USUALLY STRIKES CHILDHOOD, BUT WE'RE SEEING INCREASINGLY LARGER NUMBER OF PEOPLE IN THEIR 30s AND 40s DEVELOPING WHAT WAS CONSIDERED CLASSIC JUVENILE-ONSET DIABETES. ON THE OTHER HAND, THE VAST MAJORITY OF DIABETES THAT WE'LL BE TALKING ABOUT IS REALLY TYPE 2 DIABETES. THIS IS REALLY BEING DRIVEN, 95%, THIS IS REALLY BEING DRIVEN BY THE OBESITY EPIDEMIC THAT WE SEE IN THIS COUNTRY, AS WELL AS THE AGING OF OUR POPULATION, PARTICULARLY IN BABY BOOMERS. 1 IN 3 HAVE A DIAGNOSIS OF DIABETES. BUT ANYONE OVER 45 ARE AT GREATER RISK, AND CERTAINLY THE CHANGES IN THE DEMOGRAPHICS WITH RESPECT TO RACIAL AND ETHNIC GROUPS AND THE PROPENSITY FOR THIS DISEASE TO BE MUCH MORE COMMON IN THEM IS WHAT'S DRIVING THAT LARGE NUMBER THAT WE'RE SEEING. IN A SEPARATE CATEGORY IS GESTATIONAL DIABETES MELLITUS, AND HERE THIS IS A CIRCUMSTANCE THAT'S DIAGNOSED DURING PREGNANCY, IT ACCOUNTS FOR, DEPENDING UPON THE POPULATION, SOMEWHERE BETWEEN 2 AND 10%. ON AVERAGE, ABOUT 7% OF ALL PREGNANCIES IN THE U.S. EACH YEAR IS ASSOCIATED WITH GESTATIONAL DIABETES. OBVIOUSLY IF IT'S UNCONTROLLED, IT MAY LEAD TO OTHER COMPLICATIONS LIKE PREECLAMPSIA, AND LARGE FOR GESTATION WEIGHT BABIES, BABIES BEING HYPOGLYCEMIC AT BIRTH IF NOT APPROPRIATELY TREATED. HERE THE RISK FACTORS ARE CLEARLY OUTLINED. CLOSE RELATIVES, CERTAIN RACIAL AND ETHNIC GROUPS, 25 OR OLDER, BEING OVERWEIGHT OR HAVING HAD A PREVIOUS HISTORY OF GESTATIONAL DIABETES. AND THIS IS SO IMPORTANT THAT I REALLY WANT TO DELVE INTO THIS SUBJECT A LOT. BECAUSE I THINK THAT THIS IS WHAT IN CONTRAST, I TOLD YOU THAT JUVENILE DIABETES, FOR THE FIRST TIME WE'RE BEGINNING TO SEE IT MORE AND MORE IN OLDER PEOPLE. IN CONTRAST, WE'RE BEGINNING TO SEE WHAT USED TO BE CALLED ADULT-ONSET DIABETES MORE AND MORE IN YOUNGER ADOLESCENTS, AND WE THINK THAT GESTATIONAL DIABETES MAY BE ACTUALLY ONE OF THE CONTRIBUTORS OF THAT CHANGE IN AGE. WHAT WE KNOW CERTAINLY BASED UPON STUDYIES PUBLISHED RECENTLY IN DIABETES IN AMERICA THAT I'LL TELL YOU ABOUT IS THAT THE PREVALENCE OF GESTATIONAL DIABETES APPEARS TO BE INCREASING. THIS IS GIVING YOU A SNAPSHOT BETWEEN 1989 AND 2004, AND IT IS INCREASING IN A LARGE EXTENT. IN ADDITION, THIS IS PARTICULARLY TROUBLING IF YOU LOOK AT CERTAIN AGE GROUPS AND YOU LOOK AT THE RACIAL DIFFERENCES BETWEEN THE AGES OF 25 UP TO 25 AND 34. NOTICE THE GREAT CHANGES THAT HAVE OCCURRED, PERCENT CHANGES IN AFRICAN-AMERICAN WOMEN IN THESE AGE GROUPS COMPARED TO NON-HISPANIC WHITES BETWEEN THIS INTERVAL OF TIME. NOT ONLY IS THE PREVALENCE OF GDM INCREASING BUT ALSO IS THE INCIDENCE. HERE DATA THAT ARE TAKEN FROM THE KAISER PERMANENTE GROUP OF GESTATIONAL DIABETES REGISTRY IN NORTHERN CALIFORNIA, THIS ONLY GOES BETWEEN 1991 AND 2000, BUT YOU CAN SEE THAT THE INCIDENCE IS PARTICULARLY INCREASING. HERE YOU'RE SEEING MORE OF AN INCREASE IN ASIAN AMERICANS AS WELL AS HISPANIC AMERICANS, AND ALTHOUGH THIS GOES TO 2000, MORE RECENT DATA FROM THE NATIONWIDE STUDY, NATIONWIDE INSURANCE, STUDYING IN PATIENTS HAVE CONTINUED TO SHOW THAT THIS TREND, THIS INCIDENCE CONTINUES TO INCREASE FAIRLY -- AT A FAIRLY GOOD CLIP. SO NOT ONLY IS THE PREVALENCE INCREASING BUT THE INCIDENCE IS INCREASING, AND FOR THAT REASON, I WANT TO KIND OF GO INTO A LITTLE BIT OF DETAIL IN WHAT WE'VE LEARNED ABOUT GESTATIONAL DIABETES AND HOW IT MIGHT PROVIDE EVIDENCE FOR WHAT I -- THE CLAIM THAT I JUST MADE THAT THIS MIGHT BE EXPLAINING WHY WE'RE SEEING THIS TYPE 2 DIABETES IN ADOLESCENTS AND TEENAGERS. THIS SLIDE JUST GOES THROUGH A DEPICTION, OVERALL SCHEME OF THINGS. TYPE 2 DIABETES COMPLICATED BY GESTATIONAL DIABETES GIVES YOU A WOMAN WITH DIABETES WHO, IN THE PRESENCE OF HYPERGLYCEMIA NOT WELL KROAP KROALED, CONTROLLED, CAN HAVE A N INFANT AFFECTED BY THAT, AND IF THAT INFANT HAPPENS TO BE A DAUGHTER, THEN ONE WOULD HAVE A YOUNG WOMAN, AND BECAUSE OF THE PROPENSITY OF NOT ONLY THE MOTHER WITH GESTATIONAL DIABETES, SOMETIMES IN THE FUTURE GOING ON TO DEVELOP DIABETES HERSELF, BUT BECAUSE OF THAT MILIEU, THAT CHILD BORN FROM THAT MOTHER ALSO HAS AN INCREASED RISK OF OBESITY AND DIABETES AS I'LL PROVIDE EVIDENCE SHORTLY. BUT THIS SORT OF OVERALL DEPICTION GIVES US AN IDEA OF WHERE ARE SOME OF THE GAPS IN OUR KNOWLEDGE AND WHAT ARE SOME OPPORTUNITIES FOR RESEARCH. SO AS I POINTED OUT BEFORE, OBESITY, RACE/ETHNICITY, AGE, GENDER IN TYPE 2 DIABETES PROVIDES EXAMPLES OF HOW THESE ALL CONTRIBUTE TO THAT INCREASED RISK OF A WOMAN WITH TYPE 2 DIABETES. OBVIOUSLY THE WOMAN HAVING GESTATIONAL DIABETES ARE AT HIGHER RISK FOR TYPE 2, AND ITS COMPLICATIONS, AND ARE THERE SPECIFIC COMPLICATIONS TO THESE -- TYPE 2 DIABETES ISN'T JUST ONE DISEASE. AS WE KNOW NOW, THERE'S A HETEROGENEITY OF THESE, AND WHETHER WOMEN WHO PARTICULARLY HAVE A HISTORY OF GESTATIONAL DIABETES ULTIMATELY SUFFER DIFFERENT TYPES OF COMPLICATIONS, WHETHER THEY RESPOND TO SOME MEDICATIONS AND NOT OTHERS, AND HOW IS THAT INFORMATION IMPRINTED UPON THE DEVELOPING FETUS ARE VERY IMPORTANT AREAS OF POTENTIAL FUTURE RESEARCH. OBVIOUSLY THERE ARE NEGATIVE PREGNANCY OUTCOMES, AND WE GET MORE INFORMATION ABOUT THE DETAILS AND IDENTIFY THE CERTAIN CHARACTERISTICS ASSOCIATED. YOU HEARD FROM DR. CLAYTON ABOUT IF YOU'RE IN AMERICA AND WHAT'S HAPPENED WITH INFANT MORTALITY. CERTAINLY A LARGE NUMBER OF WOMEN THAT WE'RE SEEING WITH GESTATIONAL DIABETES, HOW MUCH IS THAT CONTRIBUTING TO THOSE SOBERING STATISTICS THAT SHE SHARED WITH YOU A MOMENT AGO. OBVIOUSLY THE INFANT HAS INCREASED RISK OF OBESITY THE IN TYPE 2 DIABETES. THIS IS IN GIRLS AND BOYS BUT IS THERE A GENDER DIFFERENCE, AND THEN FINALLY, WE MADE THIS -- AND I'LL SHOW YOU IN A MOMENT. PEOPLE WHO DEVELOP THIS VERY YOUNG TYPE 2 DIABETES, WHAT WE'VE LEARNED IS THAT THE DRUGS THAT WE TYPICALLY USE TO TREAT ADULTS WITH TYPE 2 DIABETES, WE'RE LEARNING THAT DIABETES IN THESE YOUNG ADOLESCENTS ARE HARDER TO CONTROL, OBVIOUSLY IF YOU DEVELOP DIABETES WHEN YOU'RE 20, YOU'RE GOING TO HAVE A LONG TIME TO DEVELOP THESE COMPLICATIONS COMPARED TO SOMEONE IN THEIR 50s OR 60s, WHAT WE'RE MORE USED TO. AND, THEREFORE, THERE COULD BE MORE DEVASTATING COMPLICATIONS AND A MORE AGGRESSIVE DISEASE THAN IN ADULTS THE. SO WHAT ARE SOME OF THE PROGRESS AND THE PATH FORWARDS MOVING INTO THIS AREA? WELL, OBVIOUSLY BECAUSE OF THIS MAJOR PROBLEM, WHAT I'D LIKE DO IN THE TIME IS TO REALLY HIGHLIGHT AGAIN SOME OF THESE ACRONYMS, SOME OF THESE STUDIES IN WHICH WE'VE VERY EFFECTIVE COLLABORATED WITH THE OFFICE OF RESEARCH ON WOMEN'S HEALTH AND TELL YOU ABOUT -- I'M GOING TO HIGHLIGHT OF THESE FOUR TRIALS, I'M GOING TO TELL YOU SOME DETAILS ABOUT THREE OF THESE, AND MAYBE JUST TOUCH UPON ONE OF THEM IN PASSING, TO TELL YOU HOW WE'RE TRYING TO INTERVENE IN PEOPLE AT HIGH RISK FROM NORMAL TO PRE-DIABETES, WHAT WE'RE DOING IN THE PRE-DIABETES TO TYPE 2 DIABETES SPACE TO TRY TO PREVENT PEOPLE FROM DEVELOPING TYPE 2 DIABETES, AND THEN IN KIDS IN PARTICULAR, WHAT ARE WE TRYING TO DO TO DEVELOP BETTER TREATMENTS FOR THOSE KIDS WHO MAY HAVE TYPE 2 DIABETES OF ADOLESCENCE AND YOUTH. I'M ALSO GOING TO TELL YOU ABOUT A PROGRAM IN WHICH WE'RE ENGAGED IN A COLLABORATION WITH THE CENTERS FOR DISEASE CONTROL CALLED SEARCH IN WHICH WE'RE BEGINNING TO SORT OF OBVIOUSLY EXTEND THESE OBSERVATIONS TO BEGIN TO LOOK MORE SPECIFICALLY AT DIABETES AS IT EXISTS IN THE 10 TO 19 AGE GROUP IN THE YOUTH AND WHAT'S THE CHARACTERISTIC OF THAT. IS IT STILL JUVENILE OR TO WHAT EXTENT WE'RE BEGINNING TO SEE MORE TYPE 2 DIABETES IN VARIOUS COHOMPLETS LET ME FOCUS INITIALLY ON THE DIABETES PREVENTION PROGRAM. THIS IS A STUDY THAT I THINK MANY OF YOU HAVE ALREADY HEARD ABOUT, BUT IT REALLY IS A LANDMARK TRIAL IN WHICH WE TOOK OVER 3200 PARTICIPANTS BECAUSE OF THE RATIO IN GENDER DIFFERENCES, WE OVERSAMPLED FOR MINORITY PARTICIPANTS IN THIS TRIAL, AND YOU CAN SEE ALMOST 70% OF THE THE PEOPLE INVOLVED IN THIS TRIAL WERE FEMALE. THEY ALL HAD TO HAVE IMPAIRED GLUCOSE TOLERANCE AND MOST WERE -- ALL WERE EITHER OVERWEIGHT OR OBESE, AND IN THIS TRIAL, WE REALLY ASKED A FUNDAMENTAL QUESTION, CAN WE PREVENT PEOPLE FROM GOING ON -- WITH PRE -DIABETES FROM GOING ON TO DEVELOP DIABETES IN A THREE-ARM TRIAL WHICH USES PLACEBO AND GENERAL INSTRUCTIONS IN TERMS OF HOW BEST TO EAT AND WHAT KIND OF EXERCISE ONE SHOULD DO. USING THE DRUG METFORMIN, WHICH AT THIS POINT WAS ALREADY OFF LABEL IN GENERIC FORMS, AN OFTEN THE FIRST DRUG USED IN THE TREATMENT OF PEOPLE WITH TYPE 2 DIABETES, AND A LIFESTYLE INTERVENTION, REALLY AN INTENSIVE LIFESTYLE INTERVENTION, THE DETAILS OF WHICH ARE SHOWN HERE, BUT BEFORE I SHOW YOU THIS, JUST TO HIGHLIGHT THIS LONG-STANDING COLLABORATION THAT WE'VE HAD. ONE OF THE REASONS WE WERE ABLE TO RECRUIT SO MANY ADDITIONAL WOMEN IN THIS TRIAL, PARTICULARLY FOCUSED ON GESTATIONAL DIABETES WAS THIS NIGHT NEIST COLLABORATION THIS COLLABORATION WITH DR. VIVIAN PI. NN AND DR. ALLAN SPIEGEL, DR. CLAYTON, VERY HELPFUL IN PROVIDING US WITH SOME ANNUAL SPONSORSHIP WHICH ALLOWED US TO INCREASE THE NUMBERS. THIS WAS REALLY A VERY GOOD INVESTMENT AS YOU'LL SEE IN A MOMENT. SO HERE'S A LIFESTYLE INTERVENTION, IT WA AN INTENSIVE BEHAVIORAL MODIFICATION. THE GOAL REALLY WAS A MODEST 7% WEIGHT LOSS. AND THAT WAS ACHIEVED BY DECREASING TOTAL CALORIE INTAKE, AND 150 MINUTES PER WEEK OF PHYSICAL ACTIVITY. GENERALLY 30 MINUTES A DAY, FIVE DAYS A WEEK, AND IT WAS ONLY WALKING. PEOPLE DIDN'T HAVE TO JOIN A VERY EXPENSIVE GYMNASIUM, BUT IT WAS DONE ON A ONE ON ONE BASIS IN TERMS OF THESE COUNSELING, 16 SESSIONS OF CORE CURRICULUM DELIVERED ONE ON ONE OVER A 24 WEEK PERIOD OF TIME. AFTER THIS INSTRUCTIONS WERE GIVEN, THERE WERE MONTHLY VISITS JUST TO REINFORCE WHAT HAD BEEN TAUGHT OVER THIS 16-SESSION CURRICULUM. HERE ARE THE RESULTS OUT AT FOUR YEARS, SHOWN BY KAPLAN MEIER PLOTS, AND YOU CAN SEE THIS IS A CUMULATIVE INCIDENCE OF DIABETES, THAT IS, PEOPLE WITH PRE-DIABETES GOING ON TO ACTUALLY DEVELOP DIABETES, AND USING THE PLACEBO CONTROL, YOU CAN SEE THAT OUT TO ABOUT FOUR YEARS, ABOUT A THIRD OF THEM HAVE ALREADY DEVELOPED DIABETES, DESPITE THE GENERAL INSTRUCTIONS THAT WERE GIVEN. THE METFORMIN RANDOMIZED ARM, THERE WAS ABOUT A 31% REDUCTION IN TERMS OF THE CONVERSION TO DIABETES, AND IN THE LIFESTYLE ARM, THIS WAS MORE DRAMATIC. THIS MODEST WEIGHT LOSS FROM EXERCISE AND REDUCED CALORIE INTAKE RESULTED IN ABOUT A 58% REDUCTION. THAT'S IMPORTANT AND I'LL GET BACK TO THAT IN A MOMENT. WHEN YOU ACTUALLY -- THE REASON TO ACTUALLY MAKE SURE THAT YOU INCLUDE EVERYONE IN THESE STUDIES IS THAT NOT ONLY YOU HAVE THE OPPORTUNITY TO DETERMINE WHETHER A PARTICULAR INTERVENTION COULD BE FURTHER ELABORATED OR EXTENDED TO THE GROUPS THAT WERE INCLUDED, AND WHAT THIS SHOWS, A GENERAL TREND OF PLACEBO AND A CERTAIN LEVEL, MODEST IMPROVEMENT WITH METFORMIN, AND THE BEST IMPROVEMENT WITH LIFESTYLE CARRIED ACROSS ALL RACIAL AND ETHNIC GROUPS, THAT GENERAL TREND. IF ONE LOOKS, THOUGH, IN MORE DETAIL IN TERMS OF THE AGE, A COUPLE THINGS COME OUT. THAT METFORMIN WAS ESPECIALLY EFFECTIVE IN YOUNGER ADULTS. IN COMPARISON TO YOU SEE HERE, METFORMIN, IT WAS ALMOST AS GOOD IN THESE INDIVIDUALS WHO WERE 25 TO 44 GOING INTO THE STUDY, AS THE LIFESTYLE IMPROVEMENT. BUT AS PEOPLE GOT OLDER, AND YOU CONSIDER THOSE GREATER THAN 60 AT THE TIME THAT THEY WERE RANDOMIZED IN THE TRIAL, THE METFORMIN REALLY WAS NOT VERY EFFECTIVE AT ALL. IN FACT, THERE WAS NO STA TIS IT TI STATISTICAL DIFFERENCE BETWEEN METFORMIN AND PLACEBO HERE. NOW IN CONTRAST, AND AGAIN, I WANT TO GIVE CREDIT WHERE CREDIT IS DUE, NOT ONLY WERE WE ABLE TO RECEIVE FUNDING FOR THIS, BUT WE ALSO WENT TO THE NATIONAL INSTITUTE OF AGING BECAUSE WE WANTED TO MAKE SURE THAT THERE WERE SUFFICIENT NUMBERS OF OLDER AMERICANS IN THIS TRIAL TO GIVE US A ROBUST NUMBER TO EVALUATE PEOPLE OVER 60 TO SEE WHAT HAPPENS HERE. LIFESTYLE WAS ESPECIALLY EFFECTIVE AMONG PEOPLE WHO WERE 60 YEARS OF AGE BEFORE THEY STARTED THIS TRIAL. YOU CAN SEE HERE THAT I TOLD YOU OVERALL, THE LIFESTYLE INTERVENTION WAS ABOUT 58% EFFECTIVE, BUT THEN IN MEN, ABOUT A 71% REDUCTION IN TERMS OF THE REDUCTION OF GOING ON TO DEVELOP DIABETES. THE TAKEHOME POINT FROM THIS, WE WERE TOLD THAT YOU'LL NEVER GET PEOPLE OVER 60 TO EXERCISE EVERY EXERCISE, THEY'RE NOT GOING TO SUSTAIN THIS EXERCISE. THAT DOESN'T TURN OUT TO BE THE CASE. IN FACT, EXERCISE WAS EXTREMELY IMPORTANT AND AS YOU'LL SEE IN A MOMENT, IT CONTINUES TO HAVE ENDURING EFFECTS. SO IF I CAN LEAVE YOU WITH ANYTHING ELSE, IT'S NEVER TOO LATE TO START. OKAY? LET'S BRAKE BREAKLET'S BREAK THIS DOWN OF WOMEN WHO HAD A HISTORY OF GESTATIONAL DIABETES. IF JUST FOR A MOMENT YOU LOOK AT THE WOMEN WHO DID NOT HAVE A HISTORY OF GESTATIONAL DIABETES, AND YOU COMPARE THEM TO THE WOMEN WHO HAVE HAD A HISTORY OF GESTATIONAL DIABETES AND JUST LOOK AT THE PLACEBO GROUP, THERE'S ACTUALLY A 71% INCREASE, THAT NUMBER 71 COMES UP AGAIN, INCREASE IN THOSE WITH A HISTORY OF GESTATIONAL DIABETES COMPARED TO THOSE WITHOUT IN TERMS OF THEIR TRANSFORMATION TO DIABETES. IN THIS GROUP, THE WOMEN WITHOUT GESTATIONAL DIABETES, THE METFORMIN DIDN'T WORK VERY WELL. IN FACT, THERE WAS REALLY NO DIFFERENCE BETWEEN METFORMIN VERSUS PLACEBO HERE. OF COURSE LIFESTYLE WORKS IN EVERYONE, BUT THE WOMEN WHO HAD HAD A HISTORY OF GESTATIONAL DIABETES, METFORMIN APPEARS TO BE JUST AS GOOD AS THE LIFESTYLE. METFORMIN WORKS VERY WELL IN YOUNGER PEOPLE, METFORMIN CLEARLY WORKS WELL IN WOMEN WITH A HISTORY OF GESTATIONAL DIABETES AND EVEN IF YOU CONTROL FOR THE AGE, WHICH WOULD BE THE OBVIOUS THING TO ASSUME THAT PEOPLE WHO HAVE GESTATIONAL DIABETES WERE PROBABLY YOUNGER, THAT'S STILL NOT THE CASE. METFORMIN SEEMS TO WORK PARTICULARLY WELL IN THAT POPULATION. SO JUST TO SUMMARIZE WHAT I'VE SAID, ABOUT A 58% REDUCTION AFTER FOUR YEARS WITH LIFESTYLE, 31%, BUT THIS ENDS UP BEING SORT OF AN EXPENSIVE PROPOSITION. HOW CAN YOU TAKE THE 3200 OR SO WHO ARE RANDOMIZED INTO THIS AND THEN EXPAND IT TO THE 84 MILLION BELOW THAT ICEBERG? YOU OBVIOUSLY CAN'T DO THIS FROM COST-EFFECTIVE STAND POINTS SO HOW CAN YOU DO THIS IN A WAY TO PROBABLY GET AT SOME OF THOSE PEOPLE AT GREATEST RISK? WELL, YOU DO SOMETHING THROUGH A TEAM MECHANISM, YOU GO OUT TO THE YMCA. YOU MIGHT ASK, WHY DO YOU USE THE Y? AS IT TURNS OUT, THERE ARE 2700YMCAs WITHIN THE COUNTRY AND MANY PEOPLE LIVE WITHIN A 3-MILE RADIUS OF THE Y. THE PEOPLE THERE ARE VERY PROFESSIONAL AND ABILITY TO PAY IS NOT A BARRIER TO PARTICIPATION IN ACTIVITIES AT THE Y. SO WE THOUGHT THE IF THIS COULD WORK IN THE Y, IT'S QUITE LIKELY WE COULD SCALE THIS ON A MORE NATIONAL LEVEL. AND AS IT TURNS OUT, JUST TO CUT TO THE BOTTOM LINE, DOING COUNSELING AND PROVIDING THESE 16-WEEK SESSIONS IN LARGER GROUPS OF 7 TO 10 WAS JUST AS EFFECTIVE AS THE ONE ON ONE GROUP COUNSELING. SO NOW YOU'RE ABLE TO BEND THAT COST CURVE. AT 10 YEARS, WE DID ACTUALLY AN ECONOMIC ANALYSIS ON THIS, AND FOUND THAT BECAUSE METFORMIN EVEN THOUGH THE EFFECT WAS SOMEWHAT MODEST BECAUSE IT WAS A CHEAP, INEXPENSIVE DRUG, IT TURNS OUT AT 10 YEARS THAT METFORMIN WAS ACTUALLY COST SAVINGS. AFTER PEOPLE WERE -- DEVELOPED DIABETES, OF COURSE THERE ARE COSTS ASSOCIATED WITH HOSPITALIZATIONS AND EARLY COMPLI KAIGS, BUT EVEN AT IT 10 YEARS, YOU BEGIN TO SEE SOME COST SAVINGS FROM METFORMIN AND CERTAINLY THE LIFESTYLE WAS COST-EFFECTIVE, AT LEAST AT 10 YEARS. EVEN AT 15 YEARS OF FOLLOW-UP, YOU CAN SEE THERE ARE EP DURING EFFECTS. THERE'S STILL 18% OF THE PEOPLE COMPARED TO PLACEBO WHO HAVE YET TO DEVELOP DIABETES, 15 YEARS OUT, AND ABOUT 30% OF THE INDIVIDUALS WHO GOT THAT LIFESTYLE INTERVENTION ARE STILL DIABETES-FREE. SO NOW I THINK WE BEGIN TO ACTUALLY ASK THE QUESTION ABOUT IS THIS LIFESTYLE, ESPECIALLY GIVEN IN A GROUP SETTING, LIKELY TO BE COST-EFFECTIVE. WE'RE NOW IN THE THIRD PHASE OF THIS DIABETES PREVENTION OUTCOME STUDY, O.S., AND NOW THE AVERAGE INDIVIDUAL ON THIS TRIAL, AND I HAVE TO TELL YOU THAT WE HAVE ABOUT A 95% RETENTION RATE IN MOST OF OUR TRIALS. WE'RE GOING TO ASK THE QUESTION, IS METFORMIN, WHEN GIVEN TO A PERSON WHO DOESN'T YET HAVE A DISEASE, THEY'RE NOW AT THAT AGE WHERE YOU CAN BEGIN TO ASK, ARE YOU ABLE TO PREVENT THE CARDIOVASCULAR COMPLICATIONS ASSOCIATED, THAT WOULD HAVE BEEN ASSOCIATED WITH DIABETES, AND IN CANCER. BECAUSE THERE ARE SOME INTRIGUING BUT SMALL STUDIES THAT INDICATE THAT AMONG INDIVIDUALS WHO HAVE DIABETES WHO ARE ON METFORMIN AS A FORM OF TREATMENT, THERE IS A SUBSTANTIAL REDUCTION IN THE NUMBERS AND TYPES OF CANCERS THAT THEY GET, AND WHILE I WON'T TELL YOU THE RESULTS, I CAN TELL YOU YOU THAT BECAUSE WE HAD SO MANY WOMEN PARTICIPATING IN THESE TRIALS AND WHAT SOME OF THE BASELINE INFORMATION SUGGESTED WAS THAT SOME OF THESE GYN-SPECIFIC CANCERS WERE QUITE PREVALENT, WE WILL NOW BE ABLE, WITH OUR PARTNERS AT NCI, PARTICULARLY WITH CANCER AND NHLBI WITH CARDIOVASCULAR DISEASE ND WITH ONGOING SUPPORT FROM AGING AND ORWH NOW BEGINNING TO LOOK AT WHAT HAPPENS WHEN YOU USE A DRUG BEFORE SOMEONE ACTUALLY GETS A DISEASE? CAN YOU PREVENT KNOWN COMPLICATIONS OF THAT DISEASE? LET ME NOW SHIFT FROM DIABETES PREVENTION IN ADULTS TO CIRCLE BACK ON THE IDEA OF GESTATIONAL DIABETES. BY SAYING A FEW WORDS ABOUT A STUDY CALLED HAPO, HYPERGLYCEMIA IN ADVERSE PREGNANCY OUTCOME AND ITS SUBSEQUENT TOLL-UP STUDY. FOLLOW-UP ST UDY. WE KNOW GDM FOR MANY YEARS POSES SUBSTANTIAL RISK TO THE MOTHER: HYPERTENSION, PREECLAMPSIA, DIFFICULT OR DANGEROUS DELIVERIES. MANY ACTUALLY ARE REQUIRING CESAREAN SECTIONS. BUT THERE'S ALSO A RISK TO THE BABY BEING BORN VERY LARGE OR WITH EXTRA FAT, BECAUSE OF THE HIGH LEVELS OF INSULIN THAT THE MOTHER IS PRODUCING, OFTEN THESE KIDS ARE BORN WITH LOW BLOOD GLUCOSE RIGHT AFTER BIRTH, SOME HAVE BREATHING PROBLEMS, AND OBVIOUSLY BECAUSE THEY'RE LARGE FOR GESTATIONAL AGE, DIFFICULTIES WITH DELIVERIES INCLUDING INJURIES AND SHOULDER DYSTOCIA IN PARTICULAR. BUT THIS HAPO STUDY WAS BEGINNING TO ADDRESS MORE OF A FUNDAMENTAL QUESTION. PREVIOUSLY AS GDM WAS DEFINED, IT ACTUALLY REQUIRED A CUTOFF WHERE PEOPLE ACTUALLY HAD DIABETIC LEVELS OF BLOOD GLUCOSE, BUT IS THAT A RAPID TRANSITION, IS IT EITHER YES OR NO OR IS THERE A GRADUAL PROGRESSION THAT MAYBE LOWER LEVELS OF HYPERGLYCEMIA, WHAT WERE THE SIDE EFFECTS POTENTIALLY THAT WERE IMPOSED UPON BOTH THE MOTHER AND THE CHILD AND PERHAPS LOWER BUT NOT NORMAL LEVELS OF GLYCEMIA. SO THAT WAS THE DETERMINATION, IF THERE WERE ADVERSE PERRY PERINATAL OUTCOMES ASSOCIATED WITH MATERNAL GLUCOSE INTOLERANCE LESS SEVERE THAN OVERT DIABETES. THERE WAS AN INTERNATIONAL STUDY AT 15 SITES, FUNDED BY NICHD AND CO-FUNDING FROM US. YOU CAN SEE THERE WERE OVER 25,000 WOMEN RECRUITED IN THIS TRIAL, AND THE RESULTS WERE GENERALLY BLINDED TO BOTH THE INVESTIGATOR AND THE PATIENT UNLESS THE LEVELS OF GLUCOSE, FASTING GLUCOSE OR TWO HOURS ALREADY INDICATED THEY HAD GESTATIONAL DIABETESS ABOUT BI-THE OLDER DEFINITION OR RANDOM GLUCOSE OF 160 OR FOR ONE REASON OF THE OTHER, THE WOMAN ENDED UP BEING HYPERGLYCEMIC. THESE WERE UNBLINDED, THE INFORMATION WAS GIVEN TO THEIR OBVIOUS TRITION, AND THEY WERE OBVIOUSLY TAKEN OFF THE STUDY. 746 WERE UNBLINDED AND THERE WERE ABOUT 1400 WHO DIDN'T COMPLETE THE FULL RANGE OF INVESTIGATION. THAT LEFT US WITH ABOUT 23,000 INDIVIDUALS IN WHICH -- IN AN UNBLINDED FASHION, WE COULD DETERMINE THEIR CORD BLOOD GLUCOSE AND PEPTIDES, THE LEVEL OF NEONATAL GLUCOSE WITHIN 1 TO 2 HOURS OF AGE, ANTHROPOMETRICS AND OTHER FEATURES. I'LL JUST CUT TO RESULTS HERE. THERE'S A STRONG AND CONTINUOUS INDEPENDENT ASSOCIATION BETWEEN MATERNAL GLUCOSE BELOW OVERT 9 BDs AND A NUMBER OF THESE FEATURES THAT WE'RE MEASURING. SO THIS PUT THE GLUCOSE INTO SEVEN DIFFERENT CATEGORIES. AGAIN, NOT OVERT DIABETES, BUT YOU CAN SEE IN TERMS FORT OF THE BODY WEIGHT AS THE LEVEL OF GLUCOSE INCREASED, SO WAS AN INCREASE IN WEIGHT. THE NEED FOR CESAREAN SECTION, NEONATAL HYPOGLYCEMIA AS WELL AS CORD BLOOD SERUM C PEPTIDE, WHICH IS AN INDICATOR OF THE CHILD READING THAT LEVEL OF GLYCEMIA. THE SECONDARY OUTCOMES INCLUDING NIGH NEONATAL -- THE ASSOCIATIONS WERE OBSERVED ACROSS ALL CENTERS, ACROSS THESE VARIOUS PLACES THROUGHOUT THE WORLD. AND, THEREFORE, THE RESULTS WERE GENERALIZABLE. THIS THEN LED TO THIS INTERNATIONAL ASSOCIATION OF DIABETES IN PREGNANCY AND THE WHO TO ADOPT WHAT I'LL CALL FROM NOW ON THE NEW GDM, THE NEW CRITERIA BASED UPON THESE HAPO RESULTS. BUT I HAVE TO SAY THAT THESE WEREN'T COMPLETELY ADOPTED BY ALL, INCLUDING IN THE AMERICAN SYSTEM. THEY'RE STILL USING THE OLDER DEFINITION. SO NOW YOU HAVE A STUDY IN WHICH YOU HAVE 25,000 PEOPLE WHO PARTICIPATED, AND AS I TOLD YOU BEFORE, WE REALLY WANTED TO KNOW WHAT'S GOING TO HAPPEN LONG TERM TO THE MOTHER AS WELL AS TO THE INFANT. AND THIS WAS A UNIQUE POPULATION, ONE THAT WE DIDN'T WANT TO LOSE, AND SO WE WANTED TO DO A FOLLOW-ON STUDY TO EXAMINE NOW EIGHT TO TELL YEARS LATER, AFTER DELIVERY, IS THERE AN ASSOCIATION BETWEEN MATERNAL GLUCOSE AND PREGNANCY AND ADIPOSITY IN THE OFFSPRING WHO ARE NOW 8 OR 12 YEARS OLD, AND WHAT'S THE CORRELATION BETWEEN THE GLUCOSE LEVELS AND THE MOTHERS GOING ON TO DEVELOP EITHER DIABETES OR PREDIABETES 8 TO 12 YEA RS OUT. THERE WERE A NUMBER OF SPECIFIC AIMS, SECONDARY AIMS THAT WERE INCLUDED, AND I'LL JUST CUT TO THE BOTTOM LINE. IN TERMS OF THIS NEW DEFINITION OF GDM AND THE RISK TO THE MOM, 52% DEVELOP TYPE 2 DIABETES IN USING THIS NEW DEFINITION, COMPARED TO ONLY 20% OF MOTHERS WITHOUT THIS NEW DEFINITION. SO THAT IMPLIES THERE REALLY IS NO STRICT CUTOFF, THAT THERE'S A CONTINUOUS VARIABLE. THERE'S OVER A FIVE FOLD INCREASE IN THE LIKELIHOOD OF DEVELOPING TYPE 2 DIABETES DURING THE FOLLOW-UP PIERCE OF THE MOTHERS WITH THIS NEW DIAGNOSIS ADJUSTING FOR OTHER RISK FACTORS. WHEN WE LOOKED AT THE OFFSPRING, THE RESULTS WERE SOMEWHAT MIXED. IF YOU INCLUDE BOTH OVERWEIGHT AND OBESITY AS THE VARIABLE OR AS A COMBINED OUTCOME, ONCE YOU ADJUST FOR THE MOTHER'S WEIGHT, THE RESULTS WERE REALLY NOT STATISTICALLY SIGNIFICANT. BUT IF YOU ONLY CONSIDER OBESITY, THIS NEW DEFINITION CONFERRED ABOUT A 1.58 FOLD, OBVIOUSLY STATISTICALLY SIGNIFICANT, INCREASE RISK IT TO THE CHILD. THE BOTTOM LINE HERE IS THAT THERE'S A STRONG RELATIONSHIP BETWEEN THIS NEW DEFINITION OF TYPE 2 DIABETES AND SUBSEQUENT TYPE 2 DIABETES IN THE MOTHERS, AND OBESITY IN THE OFFSPRING. AND THERE'S ONGOING ANALYSIS ABOUT THIS GLYCEMIA IN THE OFFSPRING THAT WILL LIKELY BE REPORTED SOON. YOU CAN SEE THESE RESULTS WERE ONLY REPORTED IN JAMA IN 2018. THERE WAS A LARGE MULTICENTER COHORT, WELL STANDARDIZED PROCEDURES, REALLY A MAJOR STRENGTH WAS THAT PEOPLE WERE BLINDED SO THE STANDARD OF CARE DIDN'T CHANGE IN TERMS OF HOW THE PATIENTS WERE TREATED. SO THIS NEW INTERVENTION DEFINING THIS NEW LEVEL IS OF GREAT INTEREST. I'LL TELL YOU NOW, THE QUESTION THAT STILL REMAINS IS, AS YOU KNOW, MOST WOMEN ARE NOT TESTED UNTIL 24 TO 28 WEEKS OF PREGNANCY. WHAT WE KNOW IS THAT HYPERGLYCEMIA IS PERHAPS ONE OF THE MORE SEVERE FORMS OF MUTAGEN THAT ACTUALLY EXISTS, AND MAYBE IT'S ACTUALLY OCCURRING EARLIER ON. I'LL TELL YOU ABOUT THAT IN A MOMENT, JUST TO MAKE IT A LITTLE MORE SUSPENSE FULL. BUT WHAT I WAS TELLING YOU ABOUT IN YOUTH, THE CDC DID A COLLABORATION WITH US IN 2000 IN WHICH WE BEGAN TO LOOK AT THE ONSET OF DIABETES AND ARE THERE DIFFERENCES IN TERMS OF THE CHARACTERISTICS OF THE INCIDENCE AND PREVALENCE FIGURES IN CERTAIN GROUPS AS WE SCREEN NATIONAL REPRESENTATIVE POPULATION. REPRESENTATIVE OF U.S. DIVERSITY IS REALLY THE ONLY SOURCE THAT EXISTS CURRENTLY ON NATIONAL DATA ON CHILDHOOD DIABETES, AND WHAT WE'VE FOUND IS THAT THERE'S BOTH INCREASING INCIDENCE OF BOTH TYPE 1 AND TYPE 2 DIABETES, AS ILLUSTRATED HERE. OVER THIS PERIOD OF TIME, IN 2001 TO 2009, IT TURNS OUT THAT TYPE 1 DIABETES HAS INCREASED OVER 20%. AT THE SAME TIME, TYPE 2 DIABETES HAS INCREASED ABOUT 30%. THESE ARE IN KIDS BETWEEN THE AGES OF 10 TO 19. BUT IT'S NOT UNIFORM ACROSS ALL RACIAL AND ETHNIC GROUPS. IF YOU LOOK AT NON-HISPANIC WHITES, THE VAST MAJORITY, 95% OF INDIVIDUALS IN THAT GROUP, STILL TEND TO HAVE TYPE 1 DIABETES OR WHAT WE USED TO CALL JUVENILE DIABETES. BUT THAT'S IN SHARP CONTRAST TO NON-HISPANICS, BLACKS, ASIAN AND PACIFIC ISLANDERS, IN WHICH THERE'S A 70% TYPE 1 TO 30% TYPE 2 MIXTURE. AND THAT'S COMPLETELY DIFFERENT IN WHICH THERE'S ACTUALLY A SWITCH IN AMERICAN INDIANS AND ALASKA NATIVES. IN ABOUT 70% OF WHAT'S SEEN IN TERMS OF CHILDHOOD KIEB IS ACTUALLY TYPE 2 DIABETES, AND ONLY ABOUT 30% IS TYPE 1 DIABETES. I WOULD POINT OUT, THOUGH, THAT SORT OF WHAT WE'RE LEARNING, THOUGH, IS OBVIOUSLY THIS GREAT INCREASE AT 21% IN THE PREVALENCE OF TYPE 1, BECAUSE GENES HAVEN'T CHANGED OVER THAT PERIOD OF TIME, AND WE'RE BEGINNING TO SEE TYPE 1 MORE AND MORE IN RACIAL AND ETHNIC MINORITY POPULATIONS, THAT MEANS THERE'S SOME ENVIRONMENTAL FACTORS THAT ARE TRIGGERING THIS MISGUIDED AUTOIMMUNE EFFORT THAT'S GOING ON THAT WE'RE ACTIVELY TRYING TO PURSUE. WHAT IS IT THAT'S TRIGGERING DIABETES AND TYPE 1, BOTH IN NON-HISPANIC WHITES AS WELL AS IN UNDERREPRESENTED GROUPS. LET ME TELL YOU HOW WE'RE LEARNING -- IT'S NOT NECESSARILY TRUE THAT STANDARD THERAPIES WE USE TO TREAT ADULTS WITH TYPE 2 DIABETES ARE GOING TO ACTUALLY WORK IN CHILDREN WITH TYPE 2 DIABETES. AND AGAIN, WE HAVE ANOTHER ACRONYM, THE TODAY TRIAL, WHICH STANDS FOR TREATMENT OMTIONS OF TYPE 2 DIABETES IN IN ADOLESCENTS AND YOUTH. THE RATIONALE IS CLEAR, WE'RE SEEING AN INCREASE IN YOUTH WITH TYPE 2 DIABETES, THE ADULT DRUGS HAVE NEVER BEEN TESTED, AND WE DON'T KNOW WHAT THE ADOLESCENT EFFECTS OF GLYCEMIA AND METABOLISM ARE IN TERMS OF DEVELOPING COMPLICATIONS. SO THIS COHORT WAS SET UP BETWEEN THE AGES OF 10 AND 17, ALL THESE INDIVIDUALS, GREAT MAJORITY OF THEM WERE OVERWEIGHT, AT THE 85TH PERCENTILE OF THEIR BMI. AN AVERAGE OF 35.7. THEY HAD TYPE 2 DIABETES GENERALLY LESS THAN TWO YEARS, THE AVERAGE OF EIGHT MONTHS. YOU CAN SEE THAT THIS WAS OVERREPRESENTED BY FEMALES. ONLY 35% OF THE COHORT WERE MALES, AND YOU CAN SEE THE RACIAL AND ETHNIC DISTRIBUTION SHOWN HERE. THE TREATMENT GROUPS THAT WERE ALLOCATED INCLUDED METFORMIN ALONE, METFORMIN PLUS ROSIGLITAZONE, AND METFORMIN PLUS INTENSIVE LIFESTYLE, BASED ON WHAT WE'VE ALREADY LEARNED FROM OUR DIABETES PREVENTION TRIAL, AND I HAVE TO SAY, SADLY, THAT HOW WE TREAT ADULTS JUST DOESN'T WORK AT ALL IN TERMS OF CHILDREN. WHAT I'M SHOWING HERE IS THE FAILURE RATE, THE TREATMENT FAILURE RATE IN THE THREE GROUPS SHOWN HERE THAT BOTH METFORMIN ALONE INDICATED IN BLUE, METFORMIN PLUS ROSIGLITAZONE OR METFORMIN PLUS LIFESTYLE ALL HAD UNFORTUNATE FAILURE RATES, EVEN THE BEST IN THIS CASE, METFORMIN PLUS ROSI DP. LITAZONE AT FIVE YEARS, REQUIRING INSULIN OR HAVING MAJOR DECOMPENSATION REQUIRING THEM TO GET OFF OF THE TRIAL. THERE'S THIS IS PARTICULARLY TRAGIC IN AFRICAN-AMERICANS. YOU CAN SEE HERE THAT METFORMIN ALONE THE RATE OF FAILURE WAS 66%, AND ALTHOUGH THERE WAS SOME BENEFIT TO LIFESTYLE ADDED TO THE METFORMIN, IT WAS STILL ON THE ORDER OF 45 TO 50% FAILURE RATE AT FIVE YEARS. IF YOU STRATIFY THIS BY GENDER, AGAIN, UNFORTUNATE THAT THESE REALLY DON'T WORK. IN GIRLS IN PARTICULAR, ALTHOUGH THAT COMBINATION OF METFORMIN PLUS ROSIGLITAZONE DOES PROVIDE SOME BENEFIT. THERE'S STILL ABOUT A 30% FAILURE RATE. AND THERE ARE DEFINITELY SEX AND GENDER -- THERE'S DEFINITELY GENDER DIFFERENCES IN TERMS OF THE RESPONSE TO TREATMENT, BUT OVERALL, I HAVE TO CONCLUDE THAT NONE OF THESE ARE VERY EFFECTIVE. SO IN CONCLUSION OR RATHER IN SUMMARY OF THIS ASPECT, TYPE 2 CAN BE PREVENTED OR DELAYED IN TEAM PEEM AT HIGH PEOPLE AT HIGH RISK, ESPECIALLY WOMEN WITH A HISTORY OF GDM. WOMEN WITH A HISTORY OF GDM RESPOND DIFFERENTLY AND WHAT OUR UNDERSTANDING OF WHAT CONSTITUTES GDM AND SHORT AND LONG TERM IMPACTS ON MOTHER AND OFFSPRING ARE STILL EVOLVING AND THERE STILL ARE MANY QUESTIONS TO BE ANSWERED. PREVENTION OF DIABETES IN YOUTH IS A HIGH PRIORITY DUE TO THE FACT THAT THE CURRENT TREATMENTS ARE REALLY INEFFECTIVE IN MY ESTIMATION. IN GIRLS WITH TYPE 2 DIABETES, THEY MAY EXPERIENCE EVEN GREATER ADVERSE PREGNANCY OUTCOMES. SOMETHING THAT I DIDN'T MENTION, THERE WERE A NUMBER OF UNANTICIPATED PREGNANCIES IN THIS TRIAL. THERE WERE A LARGE NUMBER OF STILLBIRTHS AND OTHER COMPLICATIONS, AND AGAIN, THAT ACTUALLY QUITE TRAGIC. THAT'S NOW LED US TO A NEW INITIATIVE TO TRY TO BETTER UNDERSTAND THE GLYCEMIC PROFILE DURING PREGNANCY, AND THE GOAL IS REALLY TO ESTABLISH A CLINICAL RESEARCH CONSORTIUM THAT CAN RECRUIT PREGNANT WOMEN IN THEIR FIRST TRIMESTER TO BEGIN TO EXAMINE THE MATERNAL BLOOD GLUCOSE LEVELS ACROSS THE SPAN OF PREGNANCY, TO CHARACTERIZE IT VERY CAREFULLY, AND THAT WILL THEN LEAD US TO AREAS IN WHICH WE CAN POTENTIALLY INTERVENE. THIS REALLY BUILDS UPON RESEARCH GAPS WHICH WERE IDENTIFIED AUGUST OF 2007 IN A WORKSHOP THAT WAS JOINTLY SPONSORED BY ORWH AND NIDDK TO LOOK SPECIFICALLY AT THIS QUESTION. IT TURNS OUT THAT THIS IS VERY TIMELY. NOVEMBER IS ACTUALLY NATIONAL DIABETES MONTH. AND SO ME GIVING THIS TALK IS QUITE TIMELY. JUST YESTERDAY, I HAD 17 RADIO INTERVIEWS IN WHICH WE WERE TALKING SPECIFICALLY ABOUT GESTATIONAL DIABETES AND HOW TO PROMOTE HEALTH AFTER GESTATIONAL DIABETES. IN ADDITION, THERE ARE GOING TO BE SEVERAL UPCOMING INTERVIEWS ON THE TOM JOINER SHOW, ERIKA CAMPBELL. WHAT WE'RE TRYING TO STRESS IN THIS CIRCUMSTANCE IS THAT WOMEN WHO HAVE HAD A HISTORY OF GESTATIONAL DIABETES REALLY NEED TO BE -- BECAUSE THEY'RE AT HIGH RISK, THEY REALLY NEED TO BE TESTED 12 WEEKS AFTER DELIVERY TO SEE WHETHER THEY HAVE PERSISTENT HYPERGLYCEMIA. THEY HAVE DIABETES, THEY NEED TO BE TREATED. IF THEY HAVE PREDIABETES, THERE ARE OBVIOUSLY THINGS THAT CAN BE DONE TO PREVENT THEM FROM GOING ON TO DEVELOP DIABETES, AND CERTAINLY IF THEY HAVE PREDIABETES, THEY NEED TO BE TESTED ON A YEARLY BASIS. IF THEY ARE BACK TO NORMAL, BECAUSE OF THEIR INCREASED RISK, THEY STILL NEED TO BE TESTED EVERY THREE YEARS. OBVIOUSLY THIS NOT ONLY AFFECTS THE MOTHER BUT IT ALSO AFFECTS THE TRIAL, AND CERTAINLY THE PEDIATRICIAN OR THE IS HEALTHCARE PROVIDER FOR THE NEEDS TO KNOW CHILD NEEDS TO KNOW ABOUT THIS AND FOLLOW THEIR GROWTH CHARTS VERY CAREFULLY BECAUSE OBESITY IN THESE KIDS IS A RISK FACTOR FOR THEM GOING ON TO DEVELOP TYPE 2 DIABETES AS AN ADOLESCENT, AND I'VE ALREADY TOLD YOU ABOUT IT'S VERY DIFFICULT TO TREAT ONCE IT'S ESTABLISHED. WHAT I DIDN'T TELL YOU IS THAT AMONG THESE KIDS WE'RE FOLLOWING TODAY, EVEN THREE TO FOUR YEARS OUT, WE'RE ALREADY BEGINNING TO SEE SIGNS OF KIDNEY DAMAGE WITH PROTEINURIA, WE'RE BEGINNING TO SEE CARDIAC DYSFUNCTION AND WE'RE BEGINNING TO SEE EARLY SIGNS OF RETINAL INVOLVEMENT OF THEIR DISEASE. SO NOT ONLY IS IT A DIFFICULT DISEASE TO TREAT, BUT THE COMPLICATIONS SEEM TO BE EARLIER AND MUCH MORE AGGRESSIVE, SO IF THE NUMBERS ARE ACTUALLY INCREASING AS WE SEE, SOMETHING VERY IMPORTANT IN TERMS OF THAT WE NEED TO SORT OF DEAL WITH. THIS IS A SORT OF A PART OF A LARGER THING, AND HERE IS AN EXAMPLE OF WHICH WE TAKE -- WE HAVE THIS RADIO SHOW THAT WE COLLABORATED WITH DR. CLAYTON ON WHERE WE PROVIDE SORT OF THESE ONE-MINUTE PIECES, HEALTHY MOMENTS, TO NOW OVER 60 MILLION LISTENERS PER WEEK, AND IT'S BROADCASTED TO TARGET AUDIENCES OVER 40 RADIO STATIONS ACROSS THE COUNTRY. WE USE THIS OPPORTUNITY, WHEN BARBARA STREISAND WAS HERE, AND BECAUSE OF HER GREAT INTEREST IN HEART DISEASE AS IT AFFECTS WOMEN, ACTUALLY THIS MONTH, THE MONTH OF OCTOBER, WE'VE COLLABORATED ON FOUR PROJECTS. ONE IS DIABETES AND HEART HEALTH, PARTICULARLY IN WOMEN, WOMEN AND HEART HEALTH RISK FACTORS, WHAT CAN WE DO ABOUT IT, AND THE MOST RECENT PSA THAT'S GOING ON THIS WEEK IS WOMEN GETTING INVOLVED IN CLINICAL TRIALS MORE BROADLY TO TRY TO INCREASE THE NUMBERS. I HAVE TO SAY THAT THIS HAS REALLY IMO 10 A GOTTEN A LOT OF ATTENTION. AS DR. CLAYTON, YOU GET SOMEONE WITH NAME RECOGNITION, THIS REALLY DOES PROMOTE THE EFFORT THAT YOU'RE TRYING TO GO ON. I WOULD POINT YOU TO OUR WEBSITE TO HEAR MS. STREISAND, YOU CAN HEAR HER ACTING THIS OUT AND IT'S REALLY BEEN GREAT. FINALLY I WANT TO POINT YOUR ATTENTION TO A RECENT PUBLICAION WE'VE HAD, "DIABETES IN AMERICA," THE THIRD EDITION. THIS IS 42 CHAPTERS, AND IT INCLUDES A CHAPTER ON BOTH GESTATIONAL DIABETES AND PRE-EXISTING DIABETES IN PREGNANCIES. FIRST EDITION WAS PUBLISHED OVER 20 YEARS AGO AND THIS MOST RECENT ONE JAIS JUST CAME OUT IN AUGUST OF 2018. IT'S FREE, IF YOU VISIT OUR WEBSITE, YOU CAN SEE IT. SO AS WE SORT OF CLOSE, I JUST WANT TO SAY THAT THE NEW STRATEGIC PLAN THAT YOU'RE GOING TO HEAR ABOUT, THE DETAILS, REALLY MESHES VERY WELL WITH SOME OF THE CORE VALUES THAT WE HAVE IN NIDDK, INCLUDING AN FAMILY CYST ON INVESTIGATOR-INITIATED RESEARCH, CLINICAL TRIALS AND STUDIES, PRESERVING A TALENT POOL OF NEW INVESTIGATORS, AND HAVING -- YOU'VE ALREADY HEARD ABOUT EXCEPTIONAL RESEARCH TRAINING AND MENTORING OPPORTUNITIES, AND OBVIOUSLY WE CAN'T END THERE. ANYTHING THAT WE LEARN WITH OUR PUBLIC FUNDING HAS TO BE DISSEMINATED AND BROUGHT OUT TO THE PUBLIC BECAUSE THEY'RE THE ONES WHO CAN BENEFIT FROM THIS, SO ASSURING KNOWLEDGE DISSEMINATION THROUGHOUTREACH IN COMMUNICATION, I THINK ALIGN BOTH WITH OUR MESSAGE AS WELL AS THE MESSAGE OF ORWH. THIS SOUNDS LIKE A COMMERCIAL BREAK, BUT FEEL FREE TO VISIT OUR WEBSITE AT NIDDK.GOV OR YOU CAN FOLLOW US ON TWITTER OR FACEBOOK. THANKS AGAIN FOR THE INVITATION AND I'M PLEASED TO ANSWER ANY QUESTIONS. [APPLAUSE] I KNOW YOU WANT TO STAY ON SCHEDULE. >> WE'LL DO ONE QUESTION. THANK YOU VERY MUCH FOR YOUR PATIENCE WITH THE FIRE DRILL. DR. REAGAN STEINER? >> FORMER DPP OR FORMER LOOK AHEADER. THANK YOU FOR YOUR WORK. >> I SEE A GOOD INITIATIVE ON GDM AND ON CHILDREN, BUT WHAT IS THE PLAN, FOR INSTANCE, WITH WOMEN AND DIABETES WHERE THERE ARE VERY STRONG GENDER DIFFERENCES, SEX DIFFERENCES IN TERMS OF DIABETES AND CARDIOVASCULAR DISEASE, AND IS THERE A FOCUS ON THAT AT NIDDK? >> THAT IS SOMETHING THAT WE ARE ACTUALLY PARTNERING WITH OUR COLLEAGUES AT NHLBI IN TERMS OF THE FOCUS OF DIABETES IN CARDIOVASCULAR DISEASE. THERE'S EVEN SOME CONCERN ACTUALLY BROUGHT UP BY SOMEONE IN COLORADO WHO THINKS THAT THERE MIGHT BE EVEN DIFFERENCES OF HOW TYPE 1 AFFECTS THE CARDIOVASCULAR SYSTEM THAN TYPE 2, FOR EXAMPLE. BUT THOSE ARE ONGOING STUDIES. WE OBVIOUSLY, YOU KNOW, ACCEPT A LOT OF APPLICATIONS THAT COME IN THAT ARE INVESTIGATOR-INITIATED, BUT WE ARE FREQUENTLY IN DISCUSSIONS WITH OUR COLLEAGUES IN NHLBI ON AREAS IN WHICH WE CAN PARTNER, AND THAT'S CERTAINLY ONE OF THEM. SO THANKS AGAIN FOR THE INVITATION. LET ME GET YOU BACK ON SCHEDULE. THANKS. [APPLAUSE] >> THANK YOU, DR. RODGERS. WE'RE GOING TO GO AHEAD AND MOVE TO OUR NEXT AGENERAL AGENDA ITEM. WE'RE GOING TO HEAR FROM DR. CHYREN HUNTER WHO'S GOING TO PROVIDE AN UPDATE ON THE BASIC AND TRANSLATIONAL RESEARCH SECTION AT ORWH. DR. HUNTER. >> I ON A NORMAL SCHEDULE I'D BE SAYING WELCOME BACK FROM THE BREAK. BUT I WILL SAY GOOD MORNING AND THANK YOU FOR AN OPPORTUNITY TO TALK WITH YOU TODAY ABOUT THE ACTIVITIES OF THE BASIC AND TRANSLATIONAL SECTION. HERE ARE THE BASIC AND TRANSLATIONAL SECTION. I HOPE YOU HAVE AN OPPORTUNITY TO TALK TO STAFF MEMBERS. SO AS DR. CLAYTON SAID IN HER OPENING REMARKS, ORWH SUPPORTS WOMEN'S HEALTH RESEARCH THROUGH A VARIETY OF CO-FUNDING PROGRAMS PROGRAMS. AND HERE THEY ARE. I'M GOING TO BE FOCUSING ON THOSE CO-FUNDING PROGRAMS THAT ARE UNDER THE PURVIEW OF THE BASIC AND TRANSLATIONAL SECTION, AND THAT'S THE SCORE PROGRAM, THE SEX AND GENDER ADMINISTRATIVE SUPPLEMENT PROGRAM, AND THE R56 PROGRAM. AS YOU SEE HERE, I'M GOING TO START WITH THE SCOR PROGRAM, STANDS FOR SPECIALIZED CENTERS OF RESEARCH EXCELLENCE ON SEX DIFFERENCES. THIS FOSTERS INTERDISCIPLINARY AND TRANSLATIONAL RESEARCH ON SEX DIFFERENCES. THE PROGRAM BEGAN IN 2002 AS A P50 OR PROGRAM PROJECT AWARD AND THESE SPECIALIZED P50s SUPPORT ANY OF THE FULL RANGE OF RESEARCH FROM THE VERY BASIC TO CLINICAL. OVER THE PAST 15 YEARS, WE HAVE HAD THREE SCOR FUNDING OPPORTUNITIES AND HAVE FUNDED 10 OR 11SCOR AWARDS. IN THE PANEL ON THE LEFT, I'D LIKE TO DRAW YOUR ATTENTION TO SOME OF THE SCOR P.I.s AND THESE SCOR P.I.s ARE FROM THE LAST COHORT OF THE SCOR RFA. WITH THAT RFA, WE FUNDED 11 SCOR AWARDS ACROSS SIX INSTITUTES AND YOU SEE THEM HERE, NIA, N. AMS, NIDDK, NIMH, NICHD AND NIDA. MANY ACRONYMS. SO THAT'S WITH OUR LAST COHORT. AND WHAT I'D LIKE TO DO NOW IS DRAW YOUR ATTENTION TO A FINDING FROM AN INVESTIGATOR FROM OUR YALE SCOR. SHE'S DOING CUTTING EDGE RESEARCH IN THE AREA OF ADDICTION. "WHEN IT COMES TO ADDICTION, SEX MATTERS." THE BOTTOM LINE -- CRAVINGS HAVE DIFFERENT ROOTS IN MEN AND WOMEN. IN FY2018, FOLLOWING AN EVALUATION OF THE SCOR PROGRAM, WE DECIDED TO CHANGE THE NAME OF THE SCOR PROGRAM FROM SCOR AND RENAME IT SCORE WITH AN E. THE REASON FOR THIS IS THAT THE SCOR INVESTIGATORS HAVE PROVEN AS THE YALE SCOR AND AS YOU'LL HEAR ON THE NEW PROGRAM, YOU'LL HEAR THESE INVESTIGATORS ARE PERFORMING CUTTING EDGE RESEARCH IN MANY FIELDS RELATED ON SEX DIFFERENCES, AND THEIR FINDINGS AND THEIR RESEARCH AND THEIR COMMITMENT TO THE STUDY OF SEX DIFFERENCES PREDATES THE NIH SABV POLICY. FOR THIS REASON, WE FELT THAT THE SCORE PROGRAM AND SCORE INVESTIGATORS AND THOSE IN THE FIELD DOING SEX DIFFERENCES WERE POISED TO NOT ONLY HAVE A RESEARCH CENTER BUT BECOME A RESEARCH CENTER OF EXCELLENCE. THUS, IN FY18, AS I SAID WE CHANGED THE NAME FROM SCOR AND WE INCLUDED A MANDATORY CAREER ENHANCEMENT CORE TO EDUCATE THE SCIENTIFIC COMMUNITY AND TRAIN THE NEXT GENERATION OF RESEARCHERS IN THE STUDY OF SEX DIFFERENCES. SO NOW WHAT IS A SCORE CENTER OF EXCELLENCE? IT'S A U54 MECHANISM WHICH IS A COOPERATIVE AGREEMENT, AND IN TALKING TO INVESTIGATORS WHEN I TALK ABOUT SCORE, I USUALLY SAY U54 MEANS YOU AND ME. BASICALLY THAT'S BECAUSE THE COOPERATIVE AGREEMENT MECHANISM ALLOWS FOR SCORE P.I.s AND THE FUNDING I.C.s, IT ALLOWS THEM THE FLEXIBILITY TO COLLABORATE ON EXCITING PROJECTS OF COMMON INTEREST TO ONE OR SEVERAL OF THE U54 PROGRAMS. SO THE OVERARCHING GOAL OF THE U54 SCORE PROGRAM AS WE ENVISIONED IT IS FOR THE CENTERS TO FUNCTION INDEPENDENTLY AND COLLECTIVELY AS NATIONAL RESOURCES WITH A CAPACITY TO DO FOUR THINGS: TO LEAD AS A NATIONAL CENTER OF RESEARCH EXCELLENCE, TO SERVE AS A POTENTIAL RESOURCE AND REPOSITORY FOR DATA, BIOSPECIMENS AND SEX AND GENDER RESEARCH TOOLS. ALSO AS WE SAID WITH THE CAREER EDUCATION CORE, BE TO EDUCATE THE SCIENTIFIC COMMUNITY AND TRAIN THE NEXT GENERATION OF BIOMEDICAL AND BEHAVIORAL RESEARCHERS. AND ALSO TO DISSEMINATE INFORMATION ON THE SEX DIFFERENCES AND THE HEALTH OF WOMEN. SO WE PUBLISHED RFA-OD-18-004 FOR A U54 SPECIALIZED CENTER OF RESEARCH EXCELLENCE AND WE WERE VERY GRATIFIED BY THE FACT THAT WE STILL HAD A VERY ROBUST RESPONSE. WE RECEIVED OVER 30 APPLICATIONS. AND BECAUSE OF THE DIVERSE NUMBER OF APPLICATIONS WE HAD, WE HAD A SPECIAL EMPHASIS PANEL THAT HAD OVER 55 REVIEWERS. IT WAS CLEARLY A GREAT REVIEW. WE WERE HONORED TO AWARD SIX U54 AWARDS AND TWO OF THE P.I.s ARE HERE TODAY, AND SOME OF THE DIVERSE SCIENTIFIC TOPIC AREAS THAT WE SUPPORTED WITH OUR SEVEN I.C. PARTNERS, AND HERE YOU SEE THAT PARTNERS NIA AND THE OTHERS HERE, SOME OF THE DIVERSE SCIENTIFIC AREAS YOU SEE, MANY OF THEM ARE IN THE FIELD OF AGING. THE HIGHLIGHT ONE, SEX-SPECIFIC EFFECTS OF ENDOCRINE DISRUPTION ON AGING AND ALZHEIMER'S DISEASE. YOU SEE A NUMBER OF THEM THAT ARE AGING-FOCUSED. WE DID HOWEVER FUND A SEX AND GENDER DICKTIVE IN ADDICTIVE DISORDERS U54 AS WELL AS SEX DIFFERENCES IN METABOLIC SYNDROME WHICH IS CO-SPONSORED BY NIDA. WE FOUND, HOWEVER, THAT WE WOULD LIKE TO DO MORE. WE UNDERSTAND THAT THERE ARE MANY FIELDS OUT THERE WHERE THE ROLE OF SEX DIFFERENCES ARE UNDERSTUDIED OR NOT ENOUGH INFORMATION IS KNOWN. SO A FEW WEEKS AGO, WE DECIDED THAT WE WOULD LIKE TO ALLOW ADDITIONAL NIH I.C.s AND ADDITIONAL SEX AND GENDER INVESTIGATORS OUT THERE TO THE OPPORTUNITY TO APPLY FOR A SCORE AWARD. SO THREE WEEKS AGO, WE PUBLISHED A NOTICE OF INTENT TO PUBLISH A SCORE ON SEX DIRCHESES, DIFFERENCES, ANOTHER RFA SIMILAR TO THE ONE WE PUBLISHED. PLEASE BE AWARE THAT THIS NOTICE -- THE SCORE RFA WILL BE PUBLISHED AND WATCH THE NIH GUIDE TO GRANTS AND CONTRACTS FOR INFORMATION ON THAT. SO NOW I'D LIKE TO TURN TO THE SEX/GENDER ADMINISTRATIVE SUPPLEMENT PROGRAM. HERE I HIGHLIGHT THE INDIVIDUALS ON OUR TEAM WHO ARE THE -- WHO SPEARHEAD THAT EFFORT. THE SEX AND GENDER ADMINISTRATORS SUPPLEMENT. THE GOAL OF THIS PROGRAM WAS TO PROVIDE INVESTIGATORS, FUNDED INVESTIGATORS, AN OPPORTUNITY TO INCREASE THEIR CONSIDERATION OF SEX AND GENDER IN THEIR RESEARCH PROGRAM. THE SUPPLEMENT PROGRAM FUNDS SUPPLEMENTARY RESEARCH ON NIH GRANTS, AND IT CAN SUPPORT PRE-CLINICAL, CLINICAL, TRANSLATIONAL OR BEHAVIORAL STUDIES, BUT THE PROJECT MUST BE WITHIN THE SCOPE OF THE PARENT PROJECTS. IN ADDITION, THE APPLICATION -- THE FUNDING OF THE GRANT MUST HAVE 18 MONTHS OF SUPPORT REMAINING ON THE GRANT TERM. AND WITH THAT, FOR EACH OF OUR A.s FOR THE ADMINISTRATOR SUPPLEMENT PROGRAM, THE MAJORITY OF NIH MECHANISM WERE ELIGIBLE FOR SUPPLEMENTAL FUNDING. THE SUPPLEMENT SUPPORTS THREE MAIN APPROACHES AS YOU SEE HERE. TO ADD A NEW SEX OR GENDER TO SAYING EL SEX, TO ADD NEW SUBJECTS TO AN EXISTING STUDY TO INCREASE THE POWER OF THAT STUDY. TO LOOK AT SEX DIFFERENCES. AND ALSO, A THIRD APPROACH IS A COMPARATIVE ANALYSIS OF EXISTING SAMPLES OR DATASETS. HERE'S A SNAPSHOT OF OUR INVESTMENT FROM 2013 TO 2017, AND AS YOU CAN SEE HERE, WE HAVE FUNDED 297 AWARDS OVER THAT TIME WITH AN INVESTMENT OF OVER $28 MILLION. AND I MUST SAY, AND OUR SECTION WOULD SAY THAT THESE SEX/GENDER SUPPLEMENTS ARE VERY DIVERSE AND CUT ACROSS ALL OF THE NIH I.C.s AND CENTERS. AND HOT OFF THE PRESSES, WE JUST FINISHED OUR FY18 SEX AND GENDER SUPPLEMENT PROGRAM, AND WE RECEIVED OVER 100 APPLICATIONS. AND WE FUNDED 44 SUPPLEMENTS, WORKING AGAIN WITH OVER 19 OF OUR NIH INSTITUTE AND CENTER PARTNERS. EXCEPTIONAL SCIENTIFIC DIVERSITY, EXCELLENT RESEARCH, AND WE'RE LOOKING FORWARD TO CONTINUING THIS PROGRAM. SO OUTCOMES FROM 2013 TO 2018, TOTAL INVESTMENT OF OVER $38 MILLION, SUPPORTING 360 PRINCIPAL INVESTIGATORS, AND MOST NIH ICs -- WITH NIH ICs AND OFFCES AS CO-SPONSORS. ONE THING I'D LIKE TO NOTE BEFORE MOVING ON IS THAT IN 2017, WITH THE COMMON FUND, WE SPONSORED A WORKSHOP TO INVITE SOME OF THOSE INVESTIGATORS WHO HAD RECEIVED SUPPLEMENTS BACK TO TELL US WHAT WORKED AND THE OUTCOMES OF THEIR -- WHAT HAPPENED WITH THEIR SUPPLEMENT SUPPORT. AND IF YOU'D LIKE TO HEAR MORE ABOUT THAT, PLEASE LOOK ON THE ORWH WEBSITE. SO NOW I'D LIKE TO TURN TO THE R56 SHORTTERM AWARDS THAT WAS MENTIONED EARLIER. AND THIS IS AN NIH INTERNAL ONLY SOLICITATION OF APPLICATIONS. AND THE GOAL OF THIS IS TO PROVIDE SHORT TERM AWARDS TO AT RISK INVESTIGATORS WHO ARE ACTUALLY INVOLVED IN INNOVATIVE, POTENTIALLY HIGH IMPACT RESEARCH. HOWEVER, THEIR RESEARCH DOES FALL OUT OF THE NORMAL I.C. PAY LINES. BUT GIVENA SHORT-TERM AWARD, IT'S FELT THAT THE SUCCESSFUL IMPLEMENTATION WITH THE SHORT TERM AWARD, THAT THEY COULD ADVANCE THE MISSION OF THE O.D. OFFICE. AND SO THERE ARE THREE O.D. OFFICES SPONSORING THESE SHORT TERM AWARDS, THE OFFICE OF RESEARCH ON WOMEN'S HEALTH, OFFICE OF DIETARY SUPPLEMENTS AND OFFICE OF AIDS RESEARCH. HERE AGAIN A LITTLE SNAPSHOT OF THE PROGRAM, ORWH HAS BEEN INVOLVED SINCE 2015, AND YOU CAN SEE THE FUNDING RIGHT HERE, AND OUR INVESTMENT BY YEAR, WHICH TOTALS A SUPPORT OF 41 INVESTIGATORS AT 11 MILLION. OVER $11 MILLION. WHAT I'D LIKE TO HIGHLIGHT HERE AS YOU SEE FROM LOOKING AT 2018, 2017, WE FUNDED HALF THE NUMBER OF R56 SHORT TERM AWARDS. INTERESTINGLY, HOWEVER, WE SEE -- WE RECEIVED THE SAME NUMBER OF APPLICATIONS IN 2017 AND 2018. BUT WHAT WE FOUND WAS THAT THE INSTITUTES, THEY HAVE RE-COMMITTED THEMSELVES TO FUNDING THESE AT-RISK INVESTIGATORS SO WE DID HAVE AN APPLICATION WE WANTED TO SUPPORT, BUT IN THE FINAL ANALYSIS, THE INSTITUTE DECIDED THAT THEY WOULD ACTUALLY SUPPORT THESE INVESTIGATORS. BUT WE AS PART OF OUR MISSION, WE ARE SUPPORTING INVESTIGATORS AND THOSE INVESTIGATORS WHO ARE STUDYING WOMEN'S HEALTH, SO WE LOOK FORWARD TO OTHER OPPORTUNITIES TO DO SO. SO I TALKED ABOUT OUR THREE COFUNDING PROGRAMS. NOW I'D LIKE TO TURN A LITTLE BIT TO HOW THE BASIC AND TRANSLATIONAL SECTION AND THE REST OF OUR OFFICE ACHIEVES OUR MISSION AND HOW WE DO THAT BY ENGAGING OUR STAKEHOLDERS. THERE ARE THREE EFFORTS I'D LIKE TO TALK TO YOU ABOUT TODAY. WE TALKED A LOT ABOUT -- DR. CLAYTON MENTIONED SEX AS A BIOLOGICAL VARIABLE. THAT'S A CROSS CUTTING ISSUE AND PRIORITY FOR OUR OFFICE, SO PART OF WHAT THE BASIC AND TRANSLATIONAL SECTION DOES IS TO PROVIDE FREQUENTLY ASKED QUESTIONS TO THE NIH OER RIGOR AND REPRODUCIBILITY WEBSITE AND THE URL IS THERE. YOU MIGHT GO THERE AND FIND SOME ANSWERS YOURSELF OR FREQUENTLY ASKED QUESTIONS ABOUT THE SABV POLICY AND WHAT THE SABV POLICY COVERS AND WHAT IT DOESN'T COVER. I'LL TALK A LITTLE BIT IN A MOMENT ABOUT OUR EFFORTS TOO PROVIDE RESOURCES AND TO DEVELOP A COURSE, I'LL TALK ABOUT THAT IN A MOMENT, TO ENHANCE THE OMENT RWH MISSION. FINALLY, I'LL TALK ABOUT THREE PRESENTATIONS THAT THE BASIC AND TRANSLATIONAL TEAM MEMBERS HAVE HELD AT THE NIH AND WITHIN THE BIOMEDICAL COMMUNITY. WE'RE VERY EXCITEED THAT WE HAVE A PARTNERSHIP WITH THE NATIONAL INSTITUTE ON GENERAL MEDICAL SCIENCES TO ESTABLISH A NEW PARTNERSHIP TO DEVELOP A PRIMER FOR SABV, AND DR. MELISSA GINN SLEEDING THIS EFFORT AS PART OF THE BASIC AND TRANSLATIONAL TEAM, AND WHAT IT'S GOING TO BE IS AN INTERACTIVE E-LEARNING COURSE TO ENHANCE AND APPROVE THE CONSIDERATION OF SABV IN RESEARCH DESIGN, ANALYSES AND REPORTING. IT'S ALSO GOING TO BE A RESOURCE FOR DESIGNING RESEARCH STUDYIES PREPARING NIH GRANT APPLICATIONS AND TRAINING THE NEXT GENERATION OF INVESTIGATORS. AND WHO'S THE AUDIENCE? THE AUDIENCE ARE RESEARCHERS OF ANY LEVEL FROM PREDOCTORAL TRAINEES TO SENIOR FACULTY. AND I MIGHT MENTION HERE THAT SENIOR FACULTY MIGHT AVAIL THEMSELVES OF THIS RESOURCE AND USE IT AS AN INSTRUCTOR GUIDE, AGAIN, FOR TRAINING NEXT GENERATION OF RESEARCHERS. AND IT'S BEING DEVELOPED, CURRENTLY WE HAVE LAUNCHED DEVELOPMENT OF THIS, AND IT'S BEING DEVELOPED BY AN ORWH DESIGNATED CONTRACTOR WITH INPUT THE FROM NIH AND NIH-DESIGNATED SUBJECT MATTER EXPERTS. THE SABV PRIMER PROVIDES AN UNDERSTANDING OF SABV POLICY AS APPLIED TO RESEARCH. SO ONE OF THE KEY LEARNING OBJECTIVES THAT WE WANT TO ACCOMPLISH WITH THIS PRIMER IS THAT EVERYONE UNDERSTAND THE NIH POLICY, CONSIDERATION OF SEX AS A BIOLOGICAL VARIABLE IN NIH-FUNDED RESEARCH. THIS IS FRAMED IN THE CONTEXT OF RIGOR AND REPRODUCIBILITY OF POLICIES. BECAUSE AS WE KNOW, THE CONSIDERATION OF SEX AS A BIOLOGICAL VARIABLE IS A KEY TENET OF RIGOROUS REPRODUCIBLE AND TRANSPARENT RESEARCH. AS YOU SEE, WE HAVE OTHER LEARNING OBJECTIVES BUT I WILL SHORTCUT HERE AND SAY THAT WE HAVE A PROPOSED LAUNCH OF AUGUST 2019. SO WE'RE ON A FAST TRACK TO DEVELOP THESE COURSES. IT'S DESIGNED TO BE THREE MODULES, THREE INDEPENDENT MODULES BUT HIGHLY INTERACTIVE. AND THEY'LL BE LEARNING EXPERIENCES, AGAIN, FOR INVESTIGATORS AT ALL LEVELS. LAST BUT NOT LEAST, SOME OF THE PRESENTATIONS THAT THE BASIC AND TRANSLATIONAL TEAM HAVE BEEN INVOLVED IN, COMING UP SHORTLY. WE'LL HAVE A REPRESENTATIVE TO THE ADOLESCENT BRAIN COGNITIVE DEVELOPMENT THAT'S ABCD ANNUAL MEETING, AND THAT'S GOING TO BE PRIOR TO THE SOCIETY FOR NEUROSCIENCE MEETING IN SAN DIEGO ON NOVEMBER 1ST. I'M JUST RETURNING FROM THE WAKE FOREST SCHOOL OF MEDICINE AND I GAVE A TALK ON ADVANCING SEX AND GENDER IN HEALTH AND DISEASE. THIS IS AN ANNUAL EVENT FOR US, WE PARTICIPATED WITH THE OFFICE OF RESEARCH AND INFRASTRUCTURE PROGRAMS TO TALK ABOUT NON-HUMAN PRIMATES AND THEIR ROLE IN -- AND THE ROLE OF THE SABV POLICY. WE HAD A POSTER AT THE SESSION IN AUGUST OF THIS YEAR AND THE POSTER ACTUALLY WON THE MOST THE BEST POSTER AWARD FOR EARLY CAREER INFORMATION SESSION. SO US A SEE, WE ARE AS YOU SEE, WE'RE VERY BUSY, WITH OUR SECTION AND ALSO ACROSS THE -- WITH OUR COLLEAGUES IN THE OTHER SECTIONS OF ORWH, AND WE ARE WORKING TOGETHER TO ACHIEVE OUR MISSION. SO IT DOES TAKE A VILLAGE, AND THANK YOU VERY MUCH FOR YOUR ATTENTION, AND I DON'T KNOW IF I HAVE TIME FOR QUESTIONS, BUT THANK YOU VERY MUCH. [APPLAUSE] >> THANK YOU, DR. HUNTER. ANY BURNING QUESTIONS? GREAT. DR. HUNTER WILL BE AVAILABLE AT THE BREAK. IS IT QUICK? >> VERY QUICK. I NOTICED THAT THE ADMINISTRATIVE SUPPLEMENT NUMBERS ARE GOING DOWN IN THE NUMBER THAT YOU'RE FUNDING. IS THAT BECAUSE PEOPLE ARE NOW PUTTING THIS INTO THEIR PARENT GRANTS? >> I WOULD HOPE SO. >> OKAY. >> SINCE THERE IS NOW A POLICY THAT REQUIRES THEM TO DO SO. WE ANTICIPATED THIS TO BE A CATALYTIC PROGRAM AND NEVER THOUGHT WE WOULD CONTINUE IT FOREVER. ONCE THE BIOMEDICAL RESEARCH COMMUNITY CAUGHT ON TO THESE NEW REQUIREMENTS. IT IS HIGHLY VARIABLE ACROSS DISCIPLINES, I WILL SAY. THE UPTAKE IS VARIABLE. BUT WE BELIEVE THAT'S THE REASON WHY EXACTLY. NOW DR. RAJEEV AGARWAL, A SENIOR RESEARCH PROGRAM OFFICER IN ORWH, IN THE BASIC AND TRANSLATIONAL SECTION, WILL INTRODUCE OUR NEXT SPEAKER. I HOPE THE FOLKS ON THE PHONE ARE STILL WITH US, AND I KNOW YOU HAVE AN EMAIL ADDRESS IF YOU WANT TO SEND QUESTIONS TO THAT EMAIL ADDRESS, PLEASE FEEL FREE TO DO SO. DR. AGARWAL. >> GOOD MORNING. OUR NEXT SPEAKER, DR. WENDY KOHRT, IS PROFESSOR OF MEDICINE IN THE NANCY -- RESEARCH AT THE UNIVERSITY OF COLORADO SCHOOL OF MEDICINE. SHE'SASSOCIATE DIRECTOR OF THE COLORADO CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTE. CENTER FOR WOMEN'S HEALTH RESEARCH. DR. KOHRT HAS BEEN CONDUCTING RESEARCH ON AGING AND -- FOR 28 YEARS. WITH AN EMPHASIS ON METABOLIC ACTIONS AND CHANGES IN BIOINER JE TICS AND METABOLISM AS A RESULT OF LOSS OF OVARIAN FUNCTION. SHE HAS RECEIVED CONTINUOUS FUNDING FROM THE NIH AS A PRINCIPAL INVESTIGATOR SINCE 1990. AND HAS PUBLISHED MORE THAN 230 RESEARCH PUBLICATIONS. SHE IS THE PRINCIPAL INVESTIGATOR FOR THREE NIH CLEARANCE INCLUDING AN R01, A U U54 PROGRAM GRANT WHICH WE JUST HEARD ABOUT, AND A U01 ON THE MOLECULAR TRANSDUCERS OF PHYSICAL ACTIVITY CONSORTIUM WHICH IS CALLED -- SHE SERVES AS CHAIR OF THE EXECUTIVE AND STUDY COMMITTEES [APPLAUSE] >> THANK YOU VERY MUCH, RAJEEV. I'D LIKE TO THANK THE LEADERSHIP OF ORWH FOR INVITING ME HERE TODAY, WHAT A PRIVILEGE THIS IS. AND I WANT TO BREAK TRADITION, USUALLY SITE CYTING PRIMARY FUNDING SOURCES AT THE END OF THE PRESENTATION, AND THRILLED TO LEARN FIVE WEEKS AGO AND QUITE FRANKLY AS THE P.I. THAT WE SUCCESSFULLY RENEWED OUR APPLICATION. SO I'M GOING TO SHARE THE WORK WE'VE BEEN DOING UNDER OUR SCORE. I'LL HAVE FOUR GENERAL SECTIONS TO MY PRESENTATION. FIRST I WANT TO LAY OUT THE WORKING MODEL THAT'S BEEN DRIVING OUR RESEARCH, TALK THEN ABOUT THE PRE-CLINICAL EVIDENCE THAT PROVIDES THE BASIS FOR TRYING TO TRANSLATE THIS TO HUMANS, TALK ABOUT SOME OF THE CLINICAL WORK WE'VE DONE AND THEN FINALLY I JUST WANT TO GIVE YOU A QUICK PREVIEW OF WHAT OUR MODEL LOOKS LIKE FOR MOVING FORWARD THE NEXT FIVE YEARS. SO, WE ARE INTERESTED IN THE DIVISION OF GERIATRIC MEDICINE AS REGARDING FAK FACTORS THAT INFLUENCE HOW WE AGE. WE DON'T AGE AS A UNIT. DIFFERENT SYSTEMS IN THE BODY AGE AT DIFFERENT RATES. AND THE LOSS OF GONADAL FUNCTION IS IMPORTANT AS AN ENDOCRINE ORGAN BECAUSE IT CAN AFFECT OTHER SYSTEMS, AND WE BELIEVE THAT THE LOSS OF GONADAL FUNCTION MAY INFLUENCE TEASE RISK. AND THIS IS PARTICULARLY IMPORTANT AND THE REASON WHY WE FOCUS MUCH OF OUR WORK ON WOMEN BECAUSE THE LOSS OF OVARIAN FUNCTION OCCURS IN MID LIFE. SO THE AVERAGE AGE OF MENOPAUSE IS 51 YEARS, AND IN CONTRAST, IN OUR MALE COUNTERPARTS, IT REMAINS CONTROVERSIAL AS TO WHETHER THERE EVEN IS AN UNAVOIDABLE LOSS OF GONADAL FUNCTION WITH AGING. IF WE LOOK AT SOME OF THE COHORT STUDIES IN MEN, EVEN AT AGE 70, ONLY 5% OF MEN ARE HYPOGONADAL AS A RESULT OF AGE-RELATED -- APPARENTLY AGE-RELATED LOSS OF GONADAL FUNCTION NOT ATTRIBUTE ATTRIBUTABLE TO OTHER REASONS. SO BECAUSE OF THIS AGE DISPARITY, AND THE FACT THAT WOMEN HAVE TO LIVE A SIGNIFICANT PORTION OF THEIR LIFE IN THE HYPOGONADAL STATE, WE'RE INTERESTED IN THE CONSEQUENCES OF THAT ON OTHER SYSTEMS. WE HAVE AN AN EXCEPTIONALLY WELL STUDIED MODEL OF THIS THAT IS THE EFFECT OF THE LOSS OF OVARIAN ESTROGEN ON THE SKELETAL SYSTEM, LEADING TO AN ACCELERATED BONE LOSS THAT INCREASES RISK FOR OSTEOCYST. BUT WE -- OSTEOPOROSIS. WE BELIEVE OTHER TISSUES MIGHT BE AFFECTED, SAY THE BRAIN OR MUSCLE, THAT COULD LEAD TO INCREASED RISK FOR CERTAIN DISEASES OR CONDITIONS LIKE DEMENTIA OR SARCOPENIA. WHAT I'M GOING TO BE FOCUSING ON TODAY IS THE ARM OF THIS ON THE RIGHT SIDE OF THE SLIDE THAT THE LOSS OF GONADAL FUNCTION MIGHT INFLUENCE A SYSTEM THAT INVOLVES MULTIPLE TISSUES OR ORGANS, SOMETHING LIKE THE REGULATION OF ENERGY BALANCE, THAT HAS THE EFFECT OF RESULTING IN EXCESSIVE FAT GAIN THAT COULD INCREASE RISK FOR OBESITY-RELATED DISEASES. AS PART OF THIS, I'M GOING TO TRY TO CONVINCE YOU THAT THE INCREASED FAT GAIN THAT OCCURS IS NOT JUST THE SAME KIND OF FAT IN IN THE SAME PLACES. THERE'S ACTUALLY A SHIFT IN WHERE FAT IS DISTRIBUTED, WHERE IT'S STORED, AND THERE MAY ALSO BE A CHANGE IN THE CELLULAR COMPOSITION OF ADIPOSE TISSUE. SO I'LL TOUCH ON THAT BRIEFLY. AND THEN WHAT'S WELL-KNOWN IN THE PRE-CLINICAL COMMUNITY BUT LESS WELL-KNOWN IN CLINICAL STUDIES IS IT THAT THE LOSS OF GONADAL FUNCTION HAS AN EFFECT ON SPONTANEOUS PHYSICAL ACTIVITY. AND I THINK YOU'LL BE AMAZED BY SOME OF THE DATA THAT I'LL SHOW YOU TODAY. AND BECAUSE PHYSICAL ACTIVITY, WE KNOW HAS BENEFITS ON MANY OF THE SYSTEMS IN THE BODY TO REDUCE RISKS FOR MULTIPLE DISEASES AND CONDITIONS, THIS MIGHT BE ANOTHER FACTOR THAT COULD INCREASE THE CONSEQUENCES OF THE LOSS OF GONADAL FUNCTION. SO LET'S GO ON AND LOOK AT SOME OF THE PRE-CLINICAL EVIDENCE THAT I'M TALKING ABOUT HERE. I LIKE TO SHOW THIS STUDY BECAUSE IT INVOLVES TWO SPECIES OF RODENTS, BOTH MICE AND RATS. THIS IS SIMPLY SHOWING YOU THE CHANGES IN BODY WEIGHT THAT OCCUR AS THE RESULT OF A SURGERY THAT REMOVES THE OVARIES, THE OVARECTOMY, VERSUS THE SAME SURGERY THAT LEAVES THE OVER RES INTACT. YOU CAN SEE WITHIN A WEEK AFTER SURGERY, THE BLUE LINES SHOW YOU THERE'S AN ACCELERATED RATE OF WEIGHT GAIN FOLLOWING OAF RECTOMEE. EVEN IF THE ANIMALS IN THOSE GROUPS ARE PAIR-FED WITH THE SHAM ANIMALS, SO EAT EXACTLY THE SAME AMOUNT OF FOOD, THEY STILL GAIN EXCESSIVE WEIGHT. THAT MUST MEAN THAT THEY MOVE LESS, AND, IN FACT, THEY DO. SO THIS IS JUST LOOKING AT LOCOMOTOR ACTIVITY IN THE CAGE A WEEK AFTER SURGERY IN BOTH SPECIES OF ANIMALS IS REDUCED BY ABOUT 30%. SO THE REMOVAL OF THE OVARIES MAKES ANIMALS LESS LIKELY TO MOVE. THERE ARE A LOT OF THINGS THAT ARE LOST WHEN YOU REMOVE THE OVARIES. ONE WAY OF LOOKING AT ISOLATING WHAT THE CONTRIBUTING FACTORS ARE TO ADD BACK HORMONES. SO THIS IS A STUDY WITH THREE DIFFERENT GROUPS OF MICE, SHAM-OPERATED, THIS TIME THEY HAVE ACCESS TO A RUNNING WHEEL IN THEIR CAGE, MICE HAVE A VERY HIGH LEVEL OF RUNNING ACTIVITY. YOU CAN SEE THEIR RUNNING ACTIVITY IS DECREASED BY 80 TO 90%. IF SEVERAL WEEKS OUT FROM THE SURGERY YOU GIVE THEM A PLACEBO TREATMENT, THERE IS NO SPONTANEOUS RECOVERY OF A RUNNING PHENOTYPE, BUT IF YOU GIVE THEM BACK ESTRA ESTRADIOL, THEY'RE RIGHT BACK IN THEIR RUNNING WHEELS. THE SAME SORT OF PHENOMENON OCCURS IN MALES, EVEN IF YOU BLOCK THE CONVERSION TO ESTROGEN THAT SEEMS TO REGULATE THEIR PHYSICAL ACTIVITY BEHAVIOR. THERE ARE OTHER CONSEQUENCES OF OVARECTOMY THAT ARE PREVENTED JUST BY ADDING BACK ESTRADIAL IN ANIMALS. LOOKING AT BODY WEIGHT IN SHAM, OVERECTOMIEZED -- YOU CAN SEE IT PREVENT THE EXCESS WEIGHT GAIN, IT PREVENTS THE EXCESS FAT GAIN. IT ALTERS RESTING METABOLIC RATE SO THIS IS ENERGY EXPENDITURE IN THE LIGHT PHASE WHEN ANIMALS ARE NORMALLY QUIET, SO IT'S A PROXY FOR RESTING METABOLIC RATE. THAT IS RESCUED BY ESTRADIAL, AND AS A FUNCTIONAL OUTCOME, THIS IS LOOKING AT GLUCOSE RATE OF DISPOSAL DURING INSULIN EXPOSURE AND INDEX OF INSULIN RESISTANCE. THAT'S IMPAIRED IN OVER RENT MIEZED ANIMALS AND RESCUED BY ESTRADIOL REPLACEMENT. I'M TRAINED AS AN EXERCISE SCIENTIST SO I'M VERY INTERESTED IN KNOWING IF AT THE TIME WOMEN LOSE ESTROGEN OR ANIMALS, IF THEY LOSE ESTROGEN AND WE HAVE ALL THESE METABOLIC CONSEQUENCES, CAN WE PREVENT SOME OF THOSE CONSEQUENCES BY A LIFESTYLE INTERVENTION. I WAS GLAD THAT GRIFF SHOWED THE RESULTS OF THE DPP BECAUSE THAT SHOWS ONE OF THE HIGHLIGHTS OF THE TRUE BENEFITS OF PHYSICAL ACTIVITY INTERVENTION. BUT THIS IS A BUSY SLIDE, I REALLY WANT YOU TO FOCUS JUST ON THE BLUE BARSMENT YOU'RE LOOKING AT CHANGE IN VISCERAL FAT AND CHANGE IN ANOTHER INDEX OF INSULIN ACTION OR DIABETES RISK. IF YOU LOOK AT THE BLUE BARS THIS, IS THE OVER ECT MIEZED GROUP. THIS IS A SEDENTARY GROUP OF ANIMALS, THE HATCHED BAR IS A GROUP OF ANIMALS WHERE THEIR PHYSICAL ACTIVITY WAS PROGRAMMED SO THEY WERE PUT ON TREAD MILLS, THEY HAD TO RUN. WHEN YOU PROGRAM THEIR EXERCISE, YOU CAN SEE THAT YOU FULLY PREVENT THESE CONSEQUENCES OF OVER ECT MEE. SO IF I SUMMARIZE THE PRE-CLINICAL EVIDENCE, I'VE SHOWED YOU THAT THE EFFECT OF OVER ECT MEE IS TO DECREASE PHYSICAL ACTIVITY, DECREASE RESTING METABOLIC RATE. I DIDN'T SHOW YOU THIS BUT IT RESULTS IN AN INCREASE IN ENERGY INTAKE IN SOME SPECIES, RATS BUT NOT MICE, AS A RESULT OF THOSE THREE DISRUPTIONS TO ENERGY BALANCE, THERE'S AN INCREASE IN TOTAL BODY ADIPOSITY BUT SPECIFICALLY ABDOMINAL ADIPOSITY, AND SINCE WE KNOW THAT ABDOMINAL FAT IS ASSOCIATED WITH METABOLIC DYSFUNCTION, IT IS NOT SURPRISING THAT WE SEE THIS IN TERMS OF DISLIB DEEM YA AND INSULIN RESISTANCE. IN THE ANIMAL STUDIES, ALL OF THESE THINGS ARE FULLY PREVENTED EITHER BY ESTRADIOL TREATMENT OR BY EXERCISE. SO THAT LEADS US TO GO INTO THE CLINICAL STUDIES THAT WE'VE BEEN DOING. EVERYBODY IN THIS ROOM PROBABLY UNDERSTANDS THAT STUDYING NATURAL MENOPAUSE IS EXTREMELY CHALLENGING. IT'S NOT AN EVENT, IT'S A PROCESS THAT TAKES PLACE OVER MANY YEARS AND MANY THINGS CHANGE OVER THOSE YEARS. SO WE'VE DIRECTED OUR RESEARCH TO USING AN EXPERIMENTAL APPROACH WHERE WE TRY TO CONTROL THE SEX HORMONE ENVIRONMENT, SO WE'VE DONE OUR STUDIES USING GONADOTROA PIN RELEASING AGONIST, IN THIS CASE, FIVE MONTHS. SO THAT SUPPRESSES OVARIAN HORMONE LEVELS TO POST-MENOPAUSAL LEVELS WITHIN ABOUT A MONTH OF STARTING TREATMENT. THEN BY ADDING BACK EITHER PLACEBO OR ESTRADIOL TREATMENT, WE HAVE A WAY OF ISOLATING THE ACTIONS OF ESTRADIOL IN WOMEN. SO IN THIS STUDY, I'M GOING TO REFER TO THIS AS A TWO-GROUP MODEL, YOU'LL SEE WHY IN THE NEXT SLIDE WE RANDOMIZE 70 WOMEN TO UNDERGO THIS INTERVENTION. AS PART OF THE GRANT, WHEN I WROTE THIS, WE HAD NO KNOWLEDGE OF WHAT SORT OF SAMPLE SIZE WE MIGHT NEED IF WE WANTED TO LOOK AT THE EFFECTIVENESS OF EXERCISE TO OFFSET WHATEVER THE CONSEQUENCES OF SUPPRESSING OVARIAN FUNCTION ARE. SO WE PROPOSED IT AS AN EXPLORATORY AIM. AND RANDOMIZED ABOUT ONE-THIRD OF THE WOMEN IN EACH GROUP TO COME TO OUR FACILITY AND PARTICIPATE IN A RESISTANCE EXERCISE INTERVENTION. SO I'LL REFER TO THIS AS THE FOUR-GROUP MODEL. AND BECAUSE IT WAS AN EXPLORATORY AIM, WE DIDN'T DO ANY INFERENTIAL STATISTICS ON THIS. WE WEREN'T ANSWERING A HYPOTHESIS, WE ARE TRYING TO GENERATE HYPOTHESES FOR THE NEXT ERA OF OUR RESEARCH. LOOKING AT THE CHANGES IN TOTAL BODY FAT-FREE MASS AND MUSCLE CROSS-SECTIONAL AREA IN OUR TWO-GROUP MODEL, YOU CAN SEE THAT THE SUPPRESSION OF OVARIAN FUNCTION RESULTED IN A .6-KILOGRAM DECREASE IN LEAN MASS THAT WAS PREVENTED BY TREATMENT WITH ESTRADIOL. SO I DON'T THINK MANY PEOPLE THAT THERE APPRECIATE THERE IS THIS LOSS OF LEAN MASS OTHER THAN JUST BONE THAT OCCURS WHEN WE SUPPRESS OVARIAN FUNCTION OR WHEN WOMEN LOSE OVARIAN FUNCTION. NOW, WATER IS A PART OF THE LEAN MASS AND ESTROGEN IS A HYDRATING HORMONE, SO THIS IS POTENTIALLY JUST A LOSS OF WATER, TOTAL BODY WATER. BUT WE DID CT SCANS OF THE MID THIGH TO GET CROSS-SECTIONAL MUSCLE AREA TO DETERMINE WHETHER THIS INDEED WAS JUST WATER OR NOT. AND YOU CAN SEE THAT THE PATTERN OF CHANGE FOR CROSS-SECTIONAL MUSCLE AREA IS IDENTICAL TO TOTAL BODY FAT-FREE MASS. SO WE REALLY THINK THAT THIS IS GOOD EVIDENCE THAT THIS IS A LOSS OF MUSCLE MASS THAT OCCURS AS A RESULT OF SUPPRESSION OF ESTROGEN LEVELS. IF WE LOOK AT THE SAME RESULTS IN OUR FOUR-GROUP MODEL NOW, THE TWO BLUE BARS ARE THE PLACEBO TREATED, THE HASHED BAR IS ADDING BACK RESISTANCE EXERCISE, THE RED BARS ARE THE ESTROGEN-TREATED GROUPS AND AGAIN THE HASH BAR IS ADDING BACK EXERCISE. JUST HYPOTHETICAL NOW BECAUSE THIS IS HYPOTHESIS-GENERATING DATA, I WOULD HYPOTHESIZE THAT EITHER EXERCISE ALONE OR ESTROGEN ALONE CAN PREVENT THE DECREASE IN LEAN MASS THAT OCCURS WITH THE SUPPRESSION OF OVARIAN HORMONES. AND WE SEE THIS VERY NICE ADDITIVE EFFECT OF BOTH. SO IT SUGGESTS THAT EXERCISE AND ESTROGEN ARE WORKING THROUGH DIFFERENT PATHWAYS TO INFLUENCE SKELETAL MUSCLE METABOLISM AND TOTAL BODY LEAN MASS. IF WE LOOK AT OUR CT DATA, WE SEE EXACTLY THE SAME PATTERN OF RESPONSE, AN EFFECT THAT'S BEING EXPRESSED IN SKELETAL MUSCLE. IF WE SWITCH NOW TO LOOKING AT FAT MASS AND I WILL SHOW YOU ABDOMINAL FAT AREAS IN A MOMENT, THIS WAS REALLY SURPRISING BECAUSE LOOK AT THE SCALE HERE. THIS IS ONLY A .1, .2-KILOGRAM INCREASE IN FAT MASS. THIS WAS SURPRISING AND I'LL SHOW YOU WHY A COUPLE OF SLIDES DOWN THE ROAD. BUT DESPITE THE FACT THAT THERE WAS NO INCREASE IN TOTAL BODY FAT MASS WHEN WE SUPPRESSED OVARIAN FUNCTION, THERE WERE SIGNIFICANT INCREASES IN BOTH SUBCUTANEOUS AND VISCERAL ABDOMINAL FAT AREA AND IN POT CASES, THAT WAS PREVENTED IN THE ESTRADIOL-TREATED GROUP. SO WE HAVE RECAPITULATED WHAT'S BEEN OBSERVED IN ANIMALS THAT THE LOSS OF ESTROGEN CAUSES THIS SHIFT IN WHERE FAT IS DISTRIBUTED, WHERE IT ACCUMULATES. IF WE LOOK AT OUR FOUR-GROUP RESULTS HERE, YOU CAN SEE WITHIN EACH DRUG TREATMENT ARM, THERE WAS AN EFFECT OF EXERCISE, AN APPARENT EFFECT OF EXERCISE TO DECREASE FAT MASS, BUT THE PATTERN OF CHANGE AND THE ABDOMINAL FAT REGIONS IS MUCH DIFFERENT THAN THIS. THESE DATA, THESE PRELIMINARY DATA DAY DATA OR EXPLORATORY DATA SUGGEST IN THE ABSENCE OF ESTROGEN, WHEN WE SUPPRESS OVARIAN FUNCTION, TO PREVENT THE ACCUMULATION OF ABDOMINAL FAT. AND THIS IS IN CONTRAST TO SOME STUDIES THAT HAVE BEEN REPORTED IN THE LITERATURE, SOME OBSERVATIONAL STUDIES. SO WE'RE GOING TO BE VERY INTERESTED TO FOLLOW UP ON THIS TO SEE IF THIS HOLDS UP IN MORE RIGOROUS STU CAN CAN STUDIES, BUT OUR DATA WOULD SUGGEST IT'S ONLY ESTROGEN TREATMENT THAT -- IN THIS COHORT, THE WOMEN WORE AN ACCELEROMETER FOR SEVEN DAYS BEFORE THEY STARTED THE INTERVENTION AND THEN DURING EACH WEEK OF THE INTERVENTION, AND YOU CAN SEE BY MONTH TWO OF TREATMENT, THESE LINES ARE BEGINNING TO DIVERGE. WITH THE ESTROGEN-TREATED GROUP HAVING HIGHER LEVELS OF MODERATE TO VIGOROUS PHYSICAL ACTIVITY THAN THE ESTROGEN-SUPPRESSED GROUP. AND I SHOULD HAVE POINTED OUT WHEN I STARTED THIS LINE OF PRESENTATION THAT WHEN WE STUDY THESE WOMEN AT BASELINE, JUST SO THAT WE CAN TIME THEIR STUDY VISITS TO THEIR MENSTRUAL CYCLE, WE STUDY THEM IN THE EARLY FOLLICULAR PHASE BECAUSE IT'S EASIER TO KNOW WHEN TO BRING THEM IN THEN. AND THEN WE RAISE THEIR ESTROGEN LEVELS TO MID FOLLICULAR TO LATE FOLLICULAR, SO WE HAVE ABOUT A TWO TO THREE FOLD INCREASE IN SERUM ESTRADIOL LEVELS WHICH IS I THINK WE WOULD SEE THIS INCREASE IN PHYSICAL ACTIVITY LEVEL, BUT MORE RESEARCH IS NEEDED IN THIS AREA ALSO. IN COLORADO, WE'RE VERY FORTUNATE TO HAVE A ROOM CALORIMETER WHERE WE CAN HOUSE PEOPLE OVERNIGHT AND MEASURE 24-HOUR ENERGY EXPENDITURE. SO IN A SUBSET OF THE WOMEN WHO PARTICIPATED IN THIS STUDY, WE WERE ABLE TO DO THAT AND MEASURE RESTING ENERGY EXPENDITURE AND TOTAL ENERGY EXPENDITURE. BASED ON THE ANIMAL STUDIES, WE HAD POSTULATED THAT THERE WOULD BE A DECREASE IN RESTING METABOLIC RATE THAT WOULD BE PREVENTED BY ESTROGEN TREATMENT AND THAT'S EXACTLY WHAT WE SAW. SO A DECREASE IN RESTING ENERGY EXPENDITURE THAT'S THE EQUIVALENT OF ABOUT 60KILOCALORIES PER DAY, WHICH DOESN'T SOUND LIKE MUCH, BUT IF A POUND OF FAT IS ABOUT 4,000 CALORIES, THAT MEANS THAT THIS IS THE EQUIVALENT OF GAINING ONE POUND OF FAT ABOUT EVERY 80 DAYS. SO IT IS SUBSTANTIAL. SUBWE ALSOSUBSTANTIAL. WE ALSO SAW A LARGER INCREASE OF ABOUT 130 KCALS PER DAY, IN THIS CASE THAT WAS NOT PREVENTED BY THE ADDITION OF DIAL TO THE ES DALE TO THE ESTRADIOL TO THE TREATMENT REGIMEN. BECAUSE WE BELIEVE MUSCLE MASS IS A CONTRIBUTOR TO RESTING ENERGY EXPENDITURE, WE MIGHT POT TEU LATE IT'S THE LOSS OF LEAN MASS IN THE SUPPRESSED GROUP THAT CONTRIBUTES TO THIS, AGAIN AS SPECULATIVE EVIDENCE HERE, THE GROUP THAT DID RESISTANCE EXERCISE WAS APPARENTLY ABLE TO PREVENT THIS DECREASE IN FAT-FREE MASS BUT WE HAVE NO SIGNAL THAT THAT INFLUENCES EITHER THEIR RESTING ENERGY EXPENDITURE OR THEIR TOTAL ENERGY EXPENDITURE. SO I THINK AT THIS POINT, THESE DATA ARE SUGGESTING THAT THERE'S A CHANGE IN METABOLIC EFFICIENCY, NOT JUST MASS THAT IS CAUSING THESE BIOENERGETIC CHANGES WITH THE LOSS OF OVARIAN FUNCTION. THIS IS THE SLIDE THAT DEMONSTRATES WHY I WAS SURPRISED THAT WE DID NOT SEE AN INCREASE IN FAT MASS. AT THE TIME I WROTE THE GRANT, THESE WERE THE OTHER STUDIES THAT HAD DEMONSTRATED THE INCREASE IN ADIPOSITY THAT OCCURS WITH ANYWHERE FROM THREE TO SIX MONTHS OF GNRH AGONIST TREATMENT. I DON'T KNOW WHY WE DIDN'T SEE AN INCREASE, BUT WE HAVE SUBSEQUENTLY, UNDER OUR SCORE, STUDIED ANOTHER COHORT OF WOMEN, SO I'M GOING TO SHOW YOU SOME UNPUBLISHED DATA HERE IN A MOMENT. BUT IN OUR NEW TRIAL WITH SIX MONTHS OF TREATMENT NOW, WE SEE WHAT WE WOULD HAVE PREDICTED TO BE THE INCREASE IN ADIPOSITY THAT'S A 1.6-KILOGRAM INCREASE IN FAT MASS OVER SIX MONTHS. THAT'S ABOUT A 90 KCAL PER DAY DISRUPTION IN ENERGY BALANCE. SO IN OUR NEW TRIAL, THIS WAS THE DESIGN WE USED. AGAIN, WE'RE USING OUR GNRH AGONIST APPROACH. THIS TIME WE DID NOT ADD BACK ESTRADIOL. WE HAVE A PLACEBO GNRH, SO THIS IS A GROUP THAT GETS PLACEBO INJECTIONS. I SHOULD ALSO SAY THIS COHORT WAS OLDER, AVERAGE AGE IN THE PREVIOUS STUDY WAS ABOUT 36 OR 37. THIS TIME WE ONLY ENROLLED WOMEN OVER THE AGE OF 40 SO THAT THEY'RE NEARING THE MENOPAUSE TRANSITION, SO THEY GOT PLACEBO TREATMENT. THE TWO GROUPS WITH GNR AGONIST, EITHER NO EXERCISE OR ENDURANCE EXERCISE ADDED BACK IN THIS CASE CASE. THESE TATA ARE INTHE MANUSCRIPT IS BEING GENERATED SO PLEASE KEEP THESE -- UNDERSTAND THAT THESE ARE PRELIMINARY RESULTS, I'M NOT GOING TO SHOW ANY STATISTICAL RESULTS YES. WE MEASURED TOTAL BODY FAT-FREE MASS AT 12 WEEKS AND AT 24 WEEKS OF TREATMENT. SO YOU CAN SEE IN THE PLACEBO ARM, THERE WERE NO CHANGES AS WE WOULD EXPECT. BUT IN THE GNRH AGONIST PLUS EXERCISE ARM, WE STILL SEE A DECREASE IN FAT-FREE MASS. AND ENDURANCE EXERCISE ISN'T A MUSCLE-BUILDING FORM OF EXERCISE. I WAS CERTAINLY HOPING THAT IT WOULD BE MUSCLE-SERVING BUT IT'S NOT LOOKING LIKE THAT'S GOING TO BE THE CASE. WHEN WE LOOK AT THE GNRH AGONIST GROUP THAT DID NOT GET RANDOMIZED TO EXERCISE, WE REALLY SEE NO DIFFERENCES THERE. IF WE LOOK AT FAT MASS, AGAIN, NO APPRECIABLE CHANGES IN THE PLACEBO GROUP OVER TIME. WE DO SEE AN INCREASE IN FAT MASS IN THE EXERCISE GROUP, BUT IT'S ONLY ABOUT HALF THE INCREASE THAT OCCURRED IN THE NO EXERCISE GROUP. I DON'T HAVE A CT SCAN TO LOOK SPECIFICALLY AT VISCERAL ADIPOSITY SO I'M SHOWING YOU CHANGES IN TRUNK FAT AS MASS, AGAIN, NO CHANGES IN THE PLACEBO GROUP. AN INCREASE IN THE EXERCISE GROUP THAT DOES NOT APPEAR TO BE DIFFERENT AND OUR INITIAL STATISTICAL ANALYSES SUGGESTS THIS IS NOT DIFFERENT. SO ONCE AGAIN, WE HAVE SOME EVIDENCE TO SUGGEST THAT EXERCISE DOES NOT PREVENT THE INCREASE IN ABDOMINAL ADIPOSITY THAT OCCURS WITH ESTROGEN DEFICIENCY. I WANT TO SPEND JUST A COUPLE OF MINUTES ON THE CELLULAR COMPOSITION THAT I MENTIONED. THAT MIGHT CHANGE AS A RESULT OF LOSS OF ESTROGEN. MY COLLEAGUE, DWIGHT CLEM, IS A BASIC ADIPOSITE BIOLOGIST. ABOUT 12 YEARS AGO, HE DISCOVERED A NOVEL LINEAGE OF WHITE ADIPOSITE. WHAT WAS STRANGE IS THAT NORMALLY, WHITE ADIPOSITES FOR 30 YEARS WERE BELIEVED TO ARISE FROM A RESIDENT STEM CELL, A RESIDENT MESENCHYMAL STEM CELL, SO THE PROGENITOR CELLS WERE THOUGHT TO LIVE IN ADIPOSE TISSUE AND GROW UP THERE. WHAT DWIGHT OBSERVED SOMEWHAT BY CHANCE WHILE HE WAS DOING A GFP, A GREEN FLUORESCENT PROTEIN-LABELED BONE MARROW TRANSPLANT IN MICE, THAT SOME OF THE CELLS IN THE FAT PADS THAT HE TOOK OUT WERE GREEN, WHICH MEANT THEY IT COME FROM A BONE DERIVED BONE MARROW -- TO UNDERSTAND HOW AND WHY THESE BONE MARROW DERIVED ADIPOCYTES END UP DEVELOPING INTO ADIPOCYTES, THESE PROGENITORS, AND WHAT THEIR FUNCTION MIGHT BE. SO THESE ARE PROGENITORS THAT HE'S DETERMINED TO BE OF MYELOID ORIGIN, NOT MESENCHYMAL LINEAGE. THEY GO THROUGH THE BLOODSTREAM, SOMEHOW END UP IN ADIPOSE TISSUE AND THERE CAN DIFFERENTIATE INTO MATURE ADIPOCYTES. NOW BECAUSE HE HAS WAYS OF LABELING THESE, HE HAS HARVESTED THE MYELOID PROGENITORS FROM ADIPOSE TISSUE AND CULTURED THEM IN AN ADIPOGENIC MEDIUM AND CAN GROW THEM UP TO BE ADIPOCYTES. IF HE HARVESTS THOSE SAME PROGENITORS OUT OF THE BLOODSTREAM AND CULTURES THEM IN ADIPOGENGGENIC MEDIUM, THEY DON'T END UP TO BE ADIPOCYTES. THEY DEVELOP A NICHE THAT ENABLES THEM TO DIFFERENTIATE INTO FAT CELLS. SOME OF THE INTERESTING THINGS ABOUT THESE BONE MARROW DERIVED ADIPOCYTES, WHEN HE COMPARES THEM WITH CONVENTIONAL ADIPOCYTES, SO HE CAN SEPARATE THEM BY FLOW CYTOMETRY FROM MOUSE ADIPOSE TISSUE, THESE BMD, BONE MARROW DERIVED ADIPOCYTES ARE HIGHLY INFLAMMATORY BY GENE EXPRESSION. SOME OF HE SIGNALS FACTORS ARE ELEVATED 50 FOLD COMPARED TO CONVENTIONAL ADIPOCYTES. IN CONTRAST, THEY HAVE LOWER LEVELS OF EXPRESSION OF MITOCHONDRIAL ENZYMES AND VERY SURPRISINGLY, VERY LOW LEVELS OF LEPTIN EXPRESSION, SO THEY DEFINITELY ARE A UNIQUE SUBTYPE OF CELL. THEY ACCUMULATE IN ALL A ADIPOSE TISSUE DEPOTS BUT THEY ACCUMULATE QUITE ABUNDANTLY IN TWO DEPOTS. ONE IS THE GONADAL, WHICH HE TELLS ME IS -- VISCERAL FAT IN HUMANS AND THE OTHER IS PERICARDIAL. HE HASN'T BEENAROUND THE HEART. SO MAYBE IT IS JUST COINCIDENTAL THAT THESE HIGHLY DIFFERENT TYPES OF FAT CELLS ACCUMULATE IN THE REGIONS THAT WE ASSOCIATE WITH METABOLIC HARM, BUT I DON'T THINK IT'S COINCIDENCE. WE THINK THIS IS GOING TO BE A MECHANISTIC UNDERPINNING FOR THE METABOLIC DYSFUNCTION ASSOCIATED WITH VISCERAL OBESITY. WE STILL HAVE PROBLEMS IDENTIFYING THESE IN HUMANS. SO THE ONLY WAY WE'VE BEEN ABLE TO DO THIS THUS FAR WAS TO USE THE SAME APPROACH THAT DWIGHT USED INITIALLY. WE STUDIED BONE MARROW TRANSPLANT PATIENTS. SO NOW WE KNOW THAT CELLS THAT COME FROM THE BONE MARROW ARE GOING TO HAVE THE SIGNATURE, THE DNA SIGNATURE OF THE DONOR. WE'VE DONE EIGHT BONE MARROW TRANSPLANT PATIENTS, WE'VE TAKEN ADIPOSE TISSUE BIOPSIES, ISOLATED THE FAT CELLS AND THE DNA, AND SEVEN OF THE EIGHT WERE POSITIVE FOR DONOR DNA. THIS HAS BEEN CONFIRMED BY A GROUP IN STOCKHOLM, SO THESE CELLS DO EXIST IN HUMANS. UNDER OUR SCORE, ONE OF THE PROJECTS I CONVINCED DWIGHT HE HAD TO DO WAS WHETHER THEY'RE REGULATED BY ENS GENERAL. SO RECENTLY PUBLISHED USING BOTH AN OVER ECT MIEZED MODEL WITH ADD BACK OF ESTRADIOL OR OH ESTROGEN RECEPTOR ALPHA KNOCKOUT MOUSE, DWIGHT HAS SHOWN THAT THERE IS THIS PROFOUND UPREGULATION OF THE ACCUMULATION OF THESE CELLS IN THE GONADAL FAT PAD AND THAT IS PREVENTED BY ESTRADIOL. THE OTHER ASPECT OF CELLULAR COMPOSITION OF ADIPOSE TISSUE THAT WE'RE LOOKING AT IS BROWN ADD TOES PISH EU, OR BROWN ADIPOCYTES. SO WE HAVE THESE VERY COOL SUITS THAT WE CAN CIRCULATE COLD WATER œTHROUGH TO CONTROL THE COLD EXPOSURE, BECAUSE BROWN ADIPOSE TISSUE IS A HIGHLY THERMOGENIC -- A HEAT-PRODUCING TISSUE SO WHEN YOU BECOME COLD, YOUR BROWN ADIPOSE TISSUE GETS TURNED ON, SO THIS IS ONE OF OUR WOMEN GETTING READY TO GO INTO OUR PET CT. WE'RE USING TWO DIFFERENTEYE TOAPS TO TWO EYES TOAPS TO TRY TO QUANTIFY UPTAKE AND BROWN ADIPOSE TISSUE IN HUMANS. SO THIS IS A FUZZY PICTD OF ONE OF PICTURE OF ONE OF OUR PET CT SCANS. OUR FIRST ATTEMPT AT THIS, THIS IS AN R01 LED BY MY COLLEAGUE ED MELANSON THAT ROSE DIRECTLY FROM THE VERY FIRST PILOT PROJECT THAT OUR SCORE SUPPORTED IN YEAR ONE OF OUR LAST SCORE THAT HE TRANSITIONED TO AN R01. IN HIS FIRST PHASE OF EXPERIMENTS, HE'S JUST COMPARING PRE AND POST MEN POST-MENOPAUSAL WOMEN. THIS IS WITH COLD EXPOSURE. YOU'RE LOOKING AT THE UPTAKE OF 18 FDG INTO DIFFERENT TISSUES YOU CAN SEE IN WHITE ADIPOSE TISSUE AND SKELETAL MUSCLE, THERE'S NO DIFFERENCE BETWEEN THESE TWO GROUPS, BUT IN BROWN œFOLD HIGHER UPTAKE IN BROWNUR ADIPOSE TISSUE OF PREMENOPAUSAL WOMEN COMPARED TO POST-MENOPAUSAL WOMEN. IF WE LOOK AT THE FUNCTIONAL CONSEQUENCE OF THIS SINCE THIS IS A HEAT PRODUCING AND ENERGY CONSUMEING TISSUE, WE KNOW THAT WE CAN MARKETEDLY INCREASE RESTING METABOLIC RATE, SO THESE WOMEN ARE JUST LYING THERE, WE'RE MEASURING ENERGY EXPENDITURE, THIS IS IN THE BASAL CONDITION AT ROOM TEMPERATURE. WE GIVE THEM THREE HOURS OF COLD EXPOSURE AND THIS IS NON-SHIVERING THERMOGENESIS. WE GET THIS HUGE INCREASE IN ENERGY EXPENDITURE AND WE HAVEN'T DONE THE STATISTICS ON THIS YET BUT IT'S LOOKING LIKE POST-MENOPAUSAL WOMEN ARE LESS RESPONSIVE TO COLD EXPOSURE. SO LET ME SUMMARIZE EVERYTHING I'VE SHARED WITH YOU TODAY. I HOPE I'VE CONVINCED YOU THAT WE HAVE PRE-CLINICAL AND CLINICAL STUDIES THAT PROVIDE VERY CONSISTENT EVIDENCE FOR THE ROLE OF ESTROGENS IN THE REGULATION OF ENERGY BALANCE. IN THESE MODELS IN ANIMALS USING OAF RECT MEE OR GNA AGONIST IN HUMANS, THE LOSS OF ESTROGEN PROMOTES FAT GAIN THROUGH MULTIPLE SYSTEM LEVEL MECHANISMS. THIS DECREASE IN RESTING METABOLIC RATE, DECREASE IN PHYSICAL ACTIVITY. WE DO SEE AN INCREASE IN ENERGY INTAKE, AND WE BELIEVE A DECREASE IN BROWN ADIPOSE TISSUE THERMOGENESIS. IN TERMS OF THE EFFECTIVENESS OF EXERCISE, THIS IS STILL AS I MENTIONED BASED ON VERY PRELIMINARY EVIDENCE, BUT IN ANIMALS, EXERCISE IS REMARKABLY EFFECTIVE AT PREVENTING MOST OF THE CONSEQUENCES OF OVARECTOMY, WHEREAS OUR PRELIMINARY STUDIES IN HUMANS SUGGEST THAT RESIST STANCE EXERCISE MAY BE EFFECTIVE AT PRESERVING MUSCLE, BUT IT DOESN'T SEEM TO HAVE AN EFFECT ON ABDOMINAL ADIPOSITY OR IN INFLUENCING BIOINER JE TICS, BIOINER JE TI CS BIO ENERGETICS. WITH THAT, I WANT TO JUST GIVE YOU A BRIEF, BRIEF PREVIEW INTO WHAT OUR NEW SCORE DIRECTIONS ARE GOING TO BE. SO OUR WORKING MODEL IS NOT THAT DIFFERENT FROM WHAT WE'VE BEEN BUILDING ON. THE LOSS OF GONADAL FUNCTION LEADING TO A DECREASE IN ESTRADIOL WHICH INCREASES ABDOMINAL OBESITY AND INCREASED DISEASE RISK, BUT THIS RED INTERSECTION IS THE NEW FOCUS SO WE'RE FOCUSING OUR SCIENCE IN THREE AREAS. WE WANT TO TRY TO LOOK AT WHETHER IT IS ESTRADIOL AND/OR FSH THAT IS MEDIATING SOME OF THESE EFFECTS. WE'RE GOING TO CONTINUE OUR WORK ON CELLULAR COMPOSITION, ESPECIALLY THE BONE MARROW-DERIVED PROGENITOR AS A MEDIATOR OF THESE THINGS AND WE'RE GOING TO LOOK AT ALTERED PERIPHERAL GLUCOCORD KOID METABOLISM AS A MECHANISM FOR THE SHIFT TOWARDS ABDOMINAL FAT ACCUMULATION, SINCE CURBING SYNDROME IS CHARACTERIZED BY ABDOMINAL ADD POS I I'M REALLY, I THINK, MOST EXCITED ABOUT THE ESTRADIOL FSH QUESTION, SO FOR THOSE OF YOU WHO AREN'T AWARE, THERE WAS THIS VERY INTRIGUING PAPER THAT CAME OUT IN "NATURE" IN JUNE OF 2017 FROM THE LABORATORIES OF CLIFF ROSEN AND MONA ZADE SHOWING THAT WHEN THEY GAVE MICE AN FSH ANTIBODY, THEY'D ALREADY SHOWN THAT IT PREVENTED OVER RECTOMEE RELATED BONE LOSS. IN THIS PAPER LAST YEAR, THEY SHOWED THAT BLOCKING FSH PREVENTED THE INCREASE IN ADIPOSITY AND SPECIFICALLY VISCERAL ADIPOSITY IN THESE ANIMALS AND CAUSED A BEIGING OF WHITE ADD TOES PISH TEU. I WAS ACTUALLY CONTACTED BY THE NEW ENGLAND JOURNAL OF MEDICINE ABOUT TWO MONTHS BEFORE THAT PAPER CAME OUT AND THEY ASKED ME TO WRITE A COMMENTARY ON THE CLINICAL IMPLICATIONS OF THIS WILL RESEARCH. AND I THINK WE ARE WELL POISED TO ADVANCE THIS AIR DRAMATICALLY WITHIN THE NEXT FEW YEARS BECAUSE ALL THREE OF OUR PROJECTS IN OUR SCORE ARE GOING TO FOCUS ON THIS FSH VERSUS ESTRADIOL QUESTION. SO IN OUR BASIC PROJECT, IN DWIGHT'S LAB, HE'S ALREADY GOT A MOUSE MODEL THAT HE'S PRIMING THAT IS GOING TO BE AN FSH RECEPTOR KNOCKOUT, BOTH A TOTAL BODY KNOCKOUT AND AN ADIPOSE TISSUE SELECTIVE KNOCKOUT KNOCKOUT. IN OUR PRE-CLINICAL STUDY LED BY PAUL MCCLAIN, HE'S GOING TO USE A MODEL THAT I WANTED TO USE IN HUMANS WHERE HE'LL GIVE RATS A GNRH AGONIST TO SUPPRESS OVARIAN FUNCTION, ADD BACK EITHER ESTRADIOL OR FSH OR THE COMBINATION OR PLACEBO. SO HE'LL BE ABLE TO ISOLATE THE ACTIONS OF EACH ONE OF THOSE HORMONES. I WANTED TO DO THAT IN HUMANS BUT WE COULDN'T FIND AN FSH PRODUCT THAT WE COULD EITHER AFFORD OR GET FSH UP TO POST-MENOPAUSAL LEVELS, SO IN OUR CLINICAL PROJECT, WE'RE GOING TO TAKE EITHER LATE PERI -- PERIMENOPAUSAL OR EARLY POST-MENOPAUSAL WOMEN WHO HAVE ELEVATED FSH LEVELS, WE'RE GOING TO PUT THEM ON EITHER THE GNRH AGONIST OR AN ANTAGONIST TO SUPPRESS THEIR FSH LEVELS TO SEE IF WE SEE ANY CHANGES IN THE SAME SORT OF MARKERS THAT HAVE BEEN OBSERVED IN ANIMALS TO CHANGE IN RESPONSE TO THE FSH ANTIBODY. SO I'M REALLY EXCITED TO MOVE THAT WORK FORWARD. AND WITH THAT, I JUST WANT TO THANK MY NETWORK HERE, BOTH MY SPONSORS AND MY RESEARCH TEAM BACK IN COLORADO. THANK YOU VERY MUCH. [APPLAUSE] >> THANK YOU, DR. KOHRT, FOR THAT WHIRLWIND EXPLORATION. INCREDIBLE DATA, AND I REALLY APPRECIATE YOU FRAMING IT IN THE CONTEXT OF HOW THE SCORE HAS REALLY MADE A BIG DIFFERENCE. >> HUGE IMPACT. >> I'M GOING TO LET THERE BE ONE QUESTION BUT I'M GOING TO TAKE THE CHAIR'S PREROGATIVE AND ASK ONE FIRST, THEN NOEL GETS TO ASK ONE QUESTION THEN WE'RE GOING TO ADJOURN FOR LUNCH. IN THE BONE MARROW TRANSPLANT WHERE YOU'RE LOOKING AT BONE MARROW DERIVED ADIPOCYTES, ARE THERE DONOR RECIPIENT PAIRS THAT YOU CAN LOOK AT FOR SOME EVEN MORE INTERESTING GLSH DWIGHT HAS DOP SOME OF THAT IN HIS MOUSE MODEL AND THERE DOES SEEM TO BE AN IMPACT WHEN THERE IS A SEX DISCORDANT TRANSPLANT. WE DON'T HAVE ENOUGH BONE MARROW TRANSPLANT PATIENTS AND IN SOME OF THEM, WE DON'T EVEN KNOW IF THEIR DONOR WAS MALE OR FEMALE SO WE HAVEN'T BEEN ABLE TO LOOG AT THAT. THE STUDY THAT WAS DONE AT THE CAROLINSKA, BECAUSE THEY HAVE A NATIONAL HEALTHCARE SYSTEM, THEY HAVE ALL OF THEIR TRANSPLANT PATIENTS WHO COME TO STOCKHOLM, I THINK THEIR SAMPLE SIZE WAS ABOUT 80 COMPARED TO EIGHT IN THEM AND ASKING THEM TO LOOK AT THAT VERY QUESTION. >> GREAT. NOEL? >> I THINK I KNOW THE ANSWER TO THIS, BUT SO IN THE CALORIE DATA IN THE HUMANS THAT WE DIDN'T GET TO SEE, DOES THAT EXPLAIN ANY OF THE VARIANTS IN THE CHANGES IN LEAN AND -- IN THE HUMANS? YOU COUNTED CALORIES IN THE ANIMALS AND YOU PROBABLY DID IN THE HUMANS BUT -- >> WE CONTROL FOR CHANGES IN BODY EXROA COMPOSITION, BOTH THE CHANGE IN LEAN MASS AND FAT-FREE MASS AND THAT DOESN'T FULLY ACCOUNT FOR THE DISRUPTIONS IN BIOINER JE TICS THAT WE SEE. SO MY CURRENT WORKING HYPOTHESIS, IT IS THAT IT IS ACUTELY A CHANGE IN BROWN ADIPOSE TISSUE METABOLISM IN THE ESTROGEN DEFICIENT STATE THAT CHANGES BIOINER JE TICS, CHANGES METABOLIC EFFICIENCY, AND I THINK OVER TIME, WITH CONTINUED SUPPRESSION, YOU'LL ACTUALLY SEE A DECREASE IN BROWN ADIPOSE TISSUE MASS. >> NO, BUT I MEANT CALORIE INTAKE. BECAUSE I -- >> OH, CALORIE INTAKE. >> THE SPECIES THAT INCREASED THEIR CALORIES IS PROBABLY HOME SAIP YENS. >> AND RATS. MICE DID NOT. WE DID THIS IN A VERY INTERESTING WAY. AND THIS WAS IN OUR ROOM CALORIMETER STUDY, WE PUT A SNACK BOX IN THERE THAT A LOT OF YUMMY THINGS IN AND WE COMPARED -- SO WE COULD MEASURE IT VERY CAREFULLY. WE COMPARED WHAT AND HOW MUCH THEY ATE IN THEIR PREINTERVENTION VISIT AND THEN THEIR POST INTERVENTION VIS I AND THEY DO INCREASE HOW MUCH THEY EAT AND INCREASE THEIR FAT CALORIE CONSUMPTION. >> SO THE NEXT TIME I GO IN AND THERE'S A SNACK BOX, I'M ONLY GOING TO EAT HALF OF THE THE GRANOLA BAR, THAT'S IT. WELL, THANK YOU VERY MUCH, DR. COURT. >> THANK YOU. [APPLAUSE] SO I WANT TO LET YOU KNOW WE'RE GOING TO ADJOURN, FOLKS ON THE WEBCAST AND ON THE PHONE, WE'RE GOING TO ADJOURN FOR LUNCH. WE DO HAVE A VERY, VERY SPECIAL GUEST HERE AT 1:00, SO PLEASE BE BACK ON TIME OR YOU'RE GOING TO MISS AN AMAZING AFTERNOON. AND SO I THINK THE FOLKS THAT ON THE COMMITTEE THAT HAVE ORDERED LUNCH, YOU KNOW THAT THAT'S IN ANOTHER ROOM AND OTHERWISE THERE'S A CAFETERIA ON THE FIRST FLOOR, BUT ADVISORY COMMITTEE MEMBERS, PLEASE GO DIRECTLY OVER TO THAT CORNER NOW, NO TALKING, NO EMAIL, SO WE CAN TAKE A PHOTOGRAPH. AND THEN YOU CAN TALK AND DO EMAIL AND EAT. BUT PLEASE -- AND WE'RE ADJOURNED UNTIL 1:00. WE ARE RECONVENED. I AM DELIGHTED TO CALL THE MEETING BACK TO ORDER. I HOPE YOU ENJOYED YOUR LUNCH AND ARE READY FOR THIS JAM-PACKED EXCITING AFTERNOON. IT'S MY PLEASURE TO INTRODUCE OUR NEXT SPEAKER, DR. JAMES ANDERSON. DR. ANDERSON IS THE DIRECTOR OF THE DIVISION OF PROGRAM COORDINATION PLANNING AND STRATEGIC INITIATIVES AND THE DEPUTY DIRECTOR FOR PLANNING COORDINATION AND STRATEGIC INITIATIVES. QUOTING DR. COLLINS HERE, DR. ANDERSON HAS A BROAD UNDERSTANDING OF THE BIOMEDICAL RESEARCH SPECTRUM, HAVING EXPERIENCE IN CLINICAL MEDICINE IN ACADEMIC RESEARCH AND ADMINISTRATION WHICH SERVES HIM AS HE WORKS TO EVALUATE, PRIORITIZE AND COORDINATE A WIDE RANGE OF TRANS-NIH RESEARCH OPPORTUNITIES. THIS DIVISION FONDLY KNOWN AS DPCPSI -- TRANSINITIATIVE SUPPORTED BY THE COMMON FUND AND ALSO COORDINATES RESEARCH RELATED TO AIDS, BEHAVIORAL AND SOCIAL SCIENCES, WOMEN'S HEALTH AND DISEASE PREVENTION. DR. ANDERSON HAS BEEN VERY SUPPORTIVE OF ORWH AND WOMEN'S HEALTH RESEARCH. PLEASE JOIN ME IN WELCOMING DR. JIM ANDERSON. [APPLAUSE] >> IT'S REALLY -- I'M DELIGHTED TO BE HERE TODAY, AND I NEVER HAVE DISAGREED WITH FRAN CIRCLES WHATEVER THAT MEANT WHAT HE FRANCIS, WHATEVER IT IS HE SAID THERE. WE HAVE THE TRIBAL HEALTH RESEARCH OFFICE, THE SEXUAL AND GENDER MINORITY RESEARCH OFFICE, SEVERAL OTHERS. THERE'S 12. IT TAKES ME A MINUTE TO RECALL THEM. THE MOST RECENT ONE WE'VE ADDED IS DATA SCIENCE. SO UNDERTAKING AND COORDINATING OUR DATA SCIENCE ACROSS THE AGENCY, WHICH IS ALWAYS A CHALLENGE. THAT'S WHY I REALLY LIKE WORKING WITH JANINE, BECAUSE SHE'S ALWAYS ON TOP OF EVERYTHING, HOW THINGS WORK. UNLIKE SOME OF OUR OTHER EFFORTS TO COORDINATE THE 27 INSTITUTES HERE. BUT I'M HERE REPRESENTING FRANCIS TO JOIN YOU AND THE OFFICE OF RESEARCH ON WOMEN'S HEALTH AND THIS COMET COMIT EE FOR COMMITTEE. I'D LIKE TO ACKNOWLEDGE AND WHO HAVE WORKED ON THIS PROJECT DILIGENTLY AND ALSO ALL OF OUR NIH COLLEAGUES WHO HAVE HAD INPUT IN HELPING TO DEVELOP THE PLAN. THIS IS TRULY A TRANS-NIH PLAN AND IT WILL BE OUR GUIDANCE FOR THE NEXT FEW YEARS. SO WITH A PLAN LIKE THIS, IT'S AN OPPORTUNITY TO REDEDICATE OURSELVES TO SCIENCE, TO WORK FOR THE HEALTH OF WOMEN. IT'S IMPORTANT WE ACKNOWLEDGE THERE ARE OTHERS HERE TODAY WHO HAVE FORGED THE WAY IN THE CRITICAL EARLY YEARS OF THE OFFICE AND IN SETTING THE AGENDA FOR WOMEN'S HEALTH, AND I'M GOING TO RECOGNIZE THEM IN A MINUTE. WE WILL RECOGNIZE THEM AS TRAILBLAZERS THAT HELPED US GET TO WHERE WE ARE TODAY, AND THEY ARE A DYNAMIC TRIO OVER THERE ON THE SIDE. THESE ARE AMAZING LEADERS WHOSE EFFORTS ARE CRITICAL IN BOTH THE FORMATION OF THIS OFFICE AND AGAIN STET SETTING THE AGENDA FOR WOMEN'S HEALTH FOR THE AGENCY AND BEYOND. SO WITHOUT FURTHER ADO, IT'S REALLY MY PLEASURE TO INTRODUCE OUR VERY SPECIAL GUEST, DR. VIVIAN PI. NN, AMBASSADOR CONNIE MORELLA, AND SENATOR BARBARA MIKULSKI. [APPLAUSE] SO YOU'LL BE HEARING FROM EACH OF THOSE, BUT FIRST WE'RE GOING TO HEAR FROM DR. PINN, WHO IS THE FIRST FULL TIME DIRECTOR OF THE OFFICE OF RESEARCH ON WOMEN'S HEALTH, HE SERVED FOR MANY YEARS IN THAT ROLE AND LED IN THE DEVELOPMENT OF MULTIPLE PREVIOUS STRATEGIC PLANS AND I STILL HAVE THE LAST ONE ON MY SHELF, THE VISION FOR 2020, THAT'S INSPIRATION. HER LEADERSHIP AND MENTORSHIP AND SHAPING OF OUR PORTFOLIO IS BOTH LEGEND AND SHE HAS LEFT US WITH A LEGACY THAT'S PUT US ON TRACK FOR FUTURE SUCCESS. SHE HAS AN IMPRESSIVE RECORD OF SERVICE NOT JUST TO NIH BUT TO THE COMMUNITY AND SHE CONTINUES TO SERVE NIH AS AN EMERITUS SCIENTIST AT THE FOGARTY CENTER. SO AGAIN, VIVIAN, GOOD TO SEE YOU. [APPLAUSE] >> I DON'T WANT TO LOSE MY WHOLE THREE MINUTES WALKING TO THE PODIUM. [LAUGHTER] THIS IS REALLY MARVELOUS, AND LOOKING BACK ON WHEN THE OFFICE FIRST STARTED, SENATOR MIKULSKI WAS REMARKING AT LUNCH ABOUT HOW THE OFFICE AND ITS PROGRAMS EXPANDED, AND ACTUALLY I THINK IT WAS REALLY GREAT THAT DR. KIRSCHSTEEN REALLY HAD THE VISION TO SAY THAT WE HAVE THIS OFFICE AND I HAVE TO KEEP REMINDING PEOPLE THAT THE OFFICE WAS REALLY ESTABLISHED TO ENSURE THE INCLUSION OF WOMEN IN CLINICAL RESEARCH. THAT WAS REALLY WHY THE OFFICE WAS FOUNDED, AND OF COURSE BUILDING ON THAT ESTABLISHING A RESEARCH AGENDA AND THEN, OF COURSE, LOOKING AT WOMEN IN BIOMEDICAL CAREERS AS PART OF THAT. BUT I THINK THAT WE DID SO WELL AT THE BEGINNING BECAUSE IT WAS THE NEW ENTERPRISE, AND SO NO ONE KNEW REALLY WHAT TO EXPECT SO WE GOT AWAY WITH A LOT IN TERMS OF SAYING WHAT WE WERE GOING TO DO. DR. HEALY JUST SAID LET ME KNOW WHAT YOU'RE GOING TO DO SO I'M NOT SURPRISED. DR. KIRSCHSTEEN WAS RIGHT THERE TO GIVE US GUIDANCE ON GOVERNMENT WAYS AND WHAT WAS APPROPRIATE TO DO, AND I THINK EVEN I WAS SURPRISED AT WHAT WE WERE ABLE TO DO OVER THE YEARS BUT THAT MAINLY WAS BECAUSE WE HAD CONGRESSIONAL SUPPORT. AND TODAY WE HAVE WITH US TWO WOMEN WHO REALLY NOT ONLY WERE RESPONSIBLE WITH THEIR REQUESTS OF THE NIH TO DETERMINE -- TO FIND OUT WHAT NIH PLANNED TO DO ABOUT THE INCLUSION OF WOMEN'S HEALTH BUT WHO FOLLOWED AND GAVE THEIR SUPPORT ON CAPITOL HILL IN THE HALLS OF CONGRESS WHERE IT WOULD BE HEARD AND REFLECT BACK TO THE AGENCIES THAT REALLY MADE A DIFFERENCE IN OUR BEING FUNDED, BECAUSE WHEN THE OFFICE FIRST STARTED, WE REALLY DIDN'T HAVE A BUDGET, IT WAS IN 1991, I THINK, 91/92 THAT OUR FIRST FUND CAME THROUGH, AND THEN GREW AFTER THAT. BUT IT WAS THEIR SUPPORT AND THEIR VOICES IN ASKING AN APPROPRIATION HEARINGS ABOUT WHAT WAS HAPPENING WITH WOMEN'S HEALTH THAT REALLY MADE A DIFFERENCE AND ALLOWED THIS OFFICE TO TAKE OFF. WITHOUT THEIR SUPPORT, I DON'T THINK WE WOULD HAVE BEEN ABLE TO DO WHAT WE DID. IT REALLY -- I STILL THINK THAT MY DUAL CAREER, THE SECOND PART OF MY CAREER, THAT OF WOMEN'S HEALTH RESEARCH AND ALL THAT THAT ENTAILED WAS PROBABLY MY MOST EXCITING PART OF MY CAREER AND I STILL TRIED TO KEEP UP SOMEWHAT WITH THAT, AND IT'S JUST EXCITING TO SEE THAT JANINE IS EXPANDING THAT VISION DOING SO MANY NEW THINGS AND IT'S ALSO VERY IMPORTANT TO HAVE AN ADVISORY COMMITTEE LIKE THIS THINK OF YOUR ROLE AND HOW IMPORTANT IT IS BECAUSE YOU ARE THE ONES, JUST READ YOUR MISSION STATEMENT IN THE CONGRESSIONAL LANGUAGE TO KNOW THAT YOU HAVE THE POWER TO RAISE QUESTIONS TO SUPPORT PROGRAMS TO SUGGEST NEW PROGRAMS AND TO RAISE QUESTIONS WHEN YOU FEEL THAT WOMEN'S HEALTH IS NOT GETTING THE ATTENTION THAT IT SHOULD. I'M RETIRED SO I CAN SAY A FEW THINGS THAN MAYBE I WOULDN'T HAVE SAID BEFORE. BUT THAT'S TRUE, SO I WANTED TO POINT THAT OUT. SO I JUST WANT TO THANK YOU FOR -- JANINE, FOR INVITING ME TO BE HERE, AND IT'S ALWAYS EXCITING FOR ME TO SEE WHAT'S HAPPENING AND HOW THE FIELD IS MOVING ON. I TAKE THIS VERY DEEPLY BECAUSE IT WAS A CHANGE IN CAREER FOR ME AND STARTING SOMETHING NEW OF COURSE WITH DR. KIRSCHSTEEN'S GUIDANCE BECAUSE THIS REALLY WAS HER VISION THAT WE HAVE THIS OFFICE OF RESEARCH ON WOMEN'S HEALTH, SO I HAVE TO GIVE HER THE CREDIT FOR ESTABLISHING THE OFFICE AND MANY OF THE THINGS THAT WE DID THAT I THINK WERE VERY IMPORTANT, LIKE WHEN WE SET A RESEARCH AGENDA TO MAKE SURE THAT WE INCLUDED A BROAD CONSTITUENCY OF VISION AND A METHOD THAT HAS CONTINUED THAT I'M PLEASED TO SEE THAT JANINE IS CONTINUING NOW. MANY OF THOSE WERE PRINCIPLES AND IDEALS THAT CAME FROM DR. KIRSCH STEEN THAT HAS SERVED US WELL. SO WITH THAT, BECAUSE I COULD SAY SO MUCH MORE AS YOU KNOW AFTER TALKING ABOUT WOMEN'S HEALTH FOR 20 SOMETHING YEARS, I THINK I CAN SOMETIMES MUMBLE ABOUT IT IN MY SLEEP AND GIVE AN INSTANT SPEECH, BUT THAT'S BECAUSE IT MEANS SO MUCH. I ONLY ASK THAT YOU CONTINUE TO BE DEDICATED TO THE CONCEPTS THAT REALLY LED TO THE MISSION STATEMENT OF THIS OFFICE AND HAVE THAT COMMITMENT BECAUSE WITHOUT THAT COMMITMENT AND THE OWNERSHIP OF WHAT THIS OFFICE CAN REPRESENT, IT WILL NOT CONTINUE TO THRIVE, ESPECIALLY IN THE POLITICAL ENVIRONMENT IN WHICH WE ARE TODAY. SO I WILL SIMPLY CLOSE BY SAYING THANK YOU FOR YOUR DEDICATION, YOU'RE ALL HERE SO OBVIOUSLY YOU'RE INTERESTED IN WOMEN'S HEALTH, THANK YOU FOR YOUR DEDICATION TO WOMEN'S HEALTH RESEARCH AND CAREERS AND SO MANY THINGS IN WHICH WE'VE MADE PROGRESS BUT THERE'S SO MUCH MORE YET TO BE DONE AND WE CANNOT ALLOW WHAT HAS BEEN ACCOMPLISHED TO MOVE BACKWARDS. AND THAT'S WHAT SCARES ME. SO IT'S UP TO YOU, I'M SITTING ON THE OUTSIDE WATCHING, AGITATING WHERE I CAN BEHIND THE THESCENES, HOPING AND KNOWING WITH JANINE TAKING THIS FORWARD THAT WITH YOUR SUPPORT, WE CAN DO GREATER THINGS THAN WE HAVE IN THE LAST 20-SOMETHING YEARS. THANK YOU VERY MUCH. >> VIVIAN, THANKS FOR YOUR FOUNDATIONAL EFFORTS TO GET THE OFFICE STARTED. I CAN REPORT TO YOU THAT YES, THEY HAVE A BUDGET, AND YES, THEY HAVE A LARGE STAFF AND YES, THEY ARE HIGHLY EFFECTIVE. WE'RE NEXT GOING TO HEAR FROM AMBASSADOR CONNIE MORELLA FROM 1987 TO 2003. SHE REPRESENTED THE MARYLAND EIGHTH CONGRESSIONAL DISTRICT IN THE HOUSE OF REPRESENTATIVES WHERE SHE DEVELOPED A NATIONAL REPUTATION FOR LEADING ADVOCACY FOR WOMEN, CHILDREN AND FAMILIES. SHE ALSO SERVED AS THE U.S. AMBASSADOR TO THE ORGANIZATION FOR ECONOMIC COOPERATION AND DEVELOPMENT IN PARIS, FROM 2003 TO 2007. SHE'S ACTUALLY THE FIRST U.S. AMBASSADOR TO THAT ORGANIZATION THAT'S EVER ALSO SERVED IN THE U.S. CONGRESS. THE AMBASSADOR HAS BEEN A TIRELESS ADVOCATE FOR WOMEN AND WOMEN'S HEALTH RESEARCH AND WE LOOK FORWARD TO HER REMARKS. THANK YOU. [APPLAUSE] >> THANK YOU, DR. ANDERSON. >> I'M CONNIE MORELLA AND I APPROVE THIS MESSAGE. TWO WEEKS FROM TODAY, IT'S GOING TO BE CRITICAL. BUT ACTUALLY THAT COMMENT CAME FROM SENATOR MCCAIN'S LEGISLATION ON CAMPAIGN FINANCE REFORM. BECAUSE IT WAS LIKE ACCOUNTABILITY. HE AND FEINGOLD THIS, I WAS INVOLVED IN THE HOUSE SIDE. BUT AT ANY RATE, I AM SO HONORED TO BE HERE. THANK YOU FOR THE INTRODUCTION. DR. ANDERSON. IT REMINDED ME OF WHAT HAD BEEN ATTRIBUTED TO LADY GAGA WHEN SHE WAS WITH TONY BENNETT, AND SHE SAID, TOO MUCH OF A GOOD THING CAN BE DOWNRIGHT ENJOYABLE. SO THANK YOU. COULD HAVE CARRIED ON A LITTLE LONGER. I'M GLAD YOU POINTED OUT THAT OECD WAS IN PARIS, BUT I SAW PEOPLE LOOKING AT ME LIKE, MMM, I DID IT FOR OUR COUNTRY. BUT WHEN I WAS IN CONGRESS, I HAD THE HONOR OF REPRESENTING NIH AS YOU KNOW. AND WE WERE THERE CURING DURING THE TIME WHERE A LOT OF WONDERFUL THINGS HAPPENED AS THEY CONTINUE TO HAPPEN, BUT EVEN THE TIME WHEN THE BUDGET WAS DOUBLED. BUT THAT MAY HAPPEN AGAIN. THINGS COME AROUND. SO I'M VERY HONORED TO BE HERE. YOU ARE ALL LEADERS IN WOMEN'S HEALTH. I ADMIRE YOU, I SALUTE YOU FOR COMING HERE AND FOR WORKING ON THIS PLAN, THE FIVE-YEAR STRATEGIC PLAN ON WOMEN'S HEALTH. AND FOLLOWING IT AS YOU CONTINUE TO PROGRESS. I'M ALSO PLEASED TO BE WITH ALL OF YOU BUT I'M PLEASED TO BE HERE WITH TWO GALS THAT I REALLY LIKE SO VERY MUCH AND ADMIRE AND HAVE WORKED WITH. AND DR. VIVIAN VIF VAN PINN WHO EVEN HAD A BUILDING NAMED FOR HER AND MY BUDDY, SENATOR BARB MIKULSKI, STRONG WILLED. SHE REMINDS ME OF A STATEMENT THAT HAD BEEN MADE ABOUT OPENING THE DOORS FOR WOMEN. IT WAS LIKE SHE DOESN'T BELIEVE IN KNOCKING ON THE DOOR, GENTLY, TO OPEN IT FOR WOMEN. SHE DOESN'T BELIEVE IN BANGING THE DOOR OPEN TO OPEN IT FOR WOMEN. SHE BELIEVES IN TAKING IT OFF ITS HINGES. SO IT STAYS OPEN. AND I THINK THAT'S VERY TRUE. BUT WE'RE HERE TODAY ALSO AND YOU HAVE US HERE TODAY TO REMEMBER, REFLECT AND RECOMMIT TO WOMEN'S HEALTH. AND TWO OF OUR FOUR MOTHERS ARE MENTIONED AND ARE WORTH MENTIONING AGAIN WHEN WE THINK OF THE SEEDS OF WOMEN'S HEALTH CONCENTRATION. AND THAT IS OF COURSE DR. RUTH KIRRISH STEEN, JUST LOVED HER, AND DR. BERNADINE HEALY, WHO WAS OUR FIRST WOMAN DIRECTOR AND WHO MOVED AHEAD WITH THE WOMEN'S PROJECT. THEY WOULD WANT US TO BUILD ON THE LEGACY THAT WE'VE CREATED AS WE MOVE INTO THE FUTURE. PROGRESS HAS BEEN GREAT, YEAH, BUT MUCH MORE NEEDS TO BE DONE, AND THAT'S WHY WE'RE HERE TOO. WE'RE NOT SATISFIED WITH STATUS QUO. WE NEED TO MOVE AHEAD. WE MUST ELIMINATE BARRIERS. WE NEED TO -- THE BARRIERS THAT STAND IN THE WAY OF WOMEN ACHIEVING, ALLOWING THEM TO REACH THEIR FULL POTENTIAL IN SCIENCE AND IN SOCIETY. I THINK IT'S IMPORTANT THAT WE ASK OURSELVES WHAT ARE THE FACTORS THAT ARE RESULTING IN WOMEN RECEIVING LESS PAY FOR THE SAME WORK, AND WHY IS THE GLASS CEILING STILL IN PLACE IN TERMS OF WOMEN SEEKING CAREERS ESPECIALLY IN STEM AND IN MEDICINE TOO. I THINK IT'S IMPORTANT WE LOOK AT WHAT THOSE BARRIERS ARE IN TERMS OF REMOVING THEM. THERE ARE MANY FACTORS SUCH AS PAY, MEDICAL, MATERNAL LEAVE. WE'RE ONE OF THE FEW COUNTRIES IN THE WORLD THAT DON'T OFFER SOMETHING IN THE WAY OF PAY FOR THAT. THE LACK OF SUPPORT FOR WOMEN IN THE WORKPLACE, IN SO MANY WAYS. THIS BECAME EVIDENT WHEN I RECENTLY HAD THE HONOR OF SERVING ON A COMMITTEE OF THE NATIONAL ASSOCIATION OF SCIENCE ASSOCIATIONS DEALING WITH SEXUAL HARASSMENT IN ACADEMIA IN SCIENCE, ENGINEERING AND MEDICINE. FULLY SUPPORTED, NIH WAS ONE OF THE SUPPORTERS, AS A MATTER OF FACT, ALONG WITH THE NATIONAL SCIENCE FOUNDATION AND NOAA, ET CETERA. SEXUAL HARASSMENT OCCURS AT LOWER RATES IN SYSTEMS IN WHICH PROHIBITIONS AGAINST UNACCEPTABLE BEHAVIOR -- I SHOULD SAY PLURAL, UNACCEPTED BEHAVIORS ARE CLEAR, AND WHICH WHOLE HOLD MEMBERS OF THE COMMUNITY ACCOUNTABLE FOR BEHAVIORAL EXPECTATIONS BY LEADERSHIP, IMPORTANT LEADERSHIP ESTABLISH THOSE CRITERIA. I WANT TO APPLAUD NIH LEADERSHIP ARE FOR LEADERSHIP FOR WORKING TO ENSURE THE NIH ANTI-HARASSMENT PROGRAM, WHICH YOU HAVE HERE, THAT IT IS IMPLEMENTED SUCCESSFULLY AND THROUGHOUT THE COMMUNITY, SO I APPLAUD YOU AND SAY CONTINUE WITH IT. THE NATIONAL ACADEMY'S REPORT FOUND THAT THE CUMULATIVE RESULT OF SEXUAL HARASSMENT IS SIGNIFICANT DAMAGE TO RESEARCH TO THE INTEGRITY INVOLVED AND IT IS A VERY COSTLY LOSS OF TALENT IN ACADEMIC SCIENCES, ENGINEERING AND MEDICINE. THIS IS A COST THAT OUR COUNTRY BEARS, AND WE CANNOT AFFORD IT. WE NEED TO MOVE FORWARD BY CREATING A MORE COLLEGIAL AND INCLUSIVE SOCIETY AND ENVIRONMENT THAT IS INCLUSIVE TO CREATE AN EQUITABLE WORKFORCE. THE PROGRAM'S MOTTO IS ONE I THINK WE COULD WELL HEED, AND THAT IS, TOGETHER WE CAN DO BETTER. AND WE MUST. AND THAT'S SO TRUE. DURING MY TIME IN CONGRESS, I SAW FIRSTHAND THE POWER OF WORKING IN PARTNERSHIP, INCLUDING WORKING ACROSS THE AISLE. WORKING ACROSS THE AISLE TO GET THINGS DONE. THIS AFTERNOON, I'M GOING TO BE GOING TO HELP LAUNCH SOMETHING CALLED THE MEDICINE PRIZE, WHICH IS GOING TO THEN BE GIVEN IN 2019 AT THE VERY BEGINNING OF THE YEAR TO A DEMOCRAT AND A REPUBLICAN IN CONGRESS THAT DEMONSTRATE COMPROMISE, DEMONSTRATE WORKING TOGETHER TO KIND OF BE AN INSPIRATION FOR OTHERS TO KNOW THAT THIS IS WHAT THE PUBLIC WANT, WORKING TOGETHER FOR WHAT'S IN THE BEST INTEREST. YOU SAW THAT HAPPEN AS YOU'VE MENTIONED WITH THE OFFICE OF RESEARCH ON WOMEN'S HEALTH. I KIND OF THINK VERY FONDLY OF THE FACT THAT IT WAS IN TERMS OF THE PEOPLE INVOLVED IN THE CONGRESSIONAL SPHERE, IT WAS BY BICAMERAL, THE SENATE AND THE HOUSE, AND IT WAS BIPARTISAN, REPUBLICAN AND DEMOCRAT. IDEAL, AND THAT'S EXACTLY THE WAY THINGS SHOULD HAPPEN, AND WE NEED TO DO FAR MORE WITH THAT. SO THAT WAS 28 YEARS AGO, WE CONTINUE TO MOVE AHEAD. WE BELIEVE AT THAT TIME THAT THERE WERE MALE GENES AND FEMALE GENES, BUT THERE WEREN'T REPUBLICAN GENES AND DEMOCRATIC GENES. SO THE WORKING TOGETHER DOES MAKE THE DIFFERENCE. I THINK OF THE FACT THAT I'VE ALWAYS ADMIRED ADMIRAL GRACE HOPPER, AND NOW THEY'RE DEDICATING A BUILDING FOR THE FIRST TIME AT THE NATIONAL NAVAL ACADEMY IN HER NAME, IN THE HONOR OF A WOMAN, SO IT'S GOING TO BE THE HOPPER BUILDING. SHE WAS THE ONE WHO WAS INVOLVED WITH COMPUTER TECHNOLOGY SO WELL. AMAZING GRACE, SHE WAS CALLED. AND SHE SAID, A SHIP IN PORT IS SAFE, BUT THAT'S NOT WHAT SHIPS ARE FOR. SAIL ON. SO I WOULD SAY WE MUST ALL SALE ON. WE MUST SALE ON TOGETHER. TO CONTINUE TO ADVANCE WOMEN'S HEALTH PERSONALLY AND PROFESSIONALLY. SO I WANT TO SAY THANK YOU, DR. CLAYTON, FOR BEING THE NIH SHIP'S CAPTAIN AS WE SAIL ON. AND SO I THINK AT THIS POINT, I JUST WANT TO THANK YOU AGAIN FOR WHAT YOU'RE DOING AND SAY, SAIL ON TO ALL OF YOU. [APPLAUSE] >> THANKS FOR THOSE INSPIRATIONAL WORDS. WE WILL SAIL ON. THIS IS A REAL HONOR FOR ME. I NEVER THOUGHT I'D GET TO INTRODUCE THE SENATOR IN MY WHOLE LIFE, THAT'S CERTAINLY A THRILL. LAST BUT NOT LEAST, WE'RE GOING TO HEAR FROM SENATOR MIKULSKI FROM THE GREAT STATE OF MARYLAND. DETERMINED TO MAKE A DIFFERENCE IN HER COMMUNITY, THE SENATOR STARTED OUT AS A SOCIAL WORKER IN BALTIMORE, HELPING AT RISK CHILDREN AND EDUCATING SENIORS ABOUT THE MEDICARE PROGRAM. SHE'S REALLY A TRAILBLAZER IN HER CAREER AND I'M GOING TO CITE SOME EXAMPLES. IN 1976, SHE RAN FOR CONGRESS AND WON AND IN '86, SHE RAN FOR THE SENATE AND WON, BECOMING THE FIRST DEMOCRATIC WOMAN SENATOR ELECTED IN HER OWN RITE. SHE WAS A LEADER IN THE SENATE, SHE WAS THE SO-CALLED DEAN OF WOMEN AND SERVED AS A MENTOR FOR OTHER WOMEN SENATORS. WHEN THEY FIRST TOOK OFFICE. AND CAME ON BOARD AS THE DEAN, SHE BUILT COALITIONS, PROVING THAT THE SENATE WOMEN ARE NOT JUST SOLO ACTS BUT THEY WORK TOGETHER TO GET THINGS DONE AS WE JUST HEARD IS REALLY THE MOST EFFECTIVE WAY TO APPROACH GOVERNMENT. WHEN SHE WAS SWORN INTO OFFICE ON JANUARY 5TH, 2011, SHE BECAME THE LONGEST SERVING WOMAN SENATOR IN U.S. HISTORY. IN MARCH OF -- OF THESE MILESTONES, SHE ONCE SAID IT'S NOT ABOUT HOW LONG I SERVE, IT'S ABOUT HOW WELL I SERVE MY STATE AND MY NATION. AGAIN, ON DECEMBER 20TH, 2012, SHE BECAME THE FIRST WOMAN AND FIRST MARYLANDER TO CHAIR THE SENATE APPROPRIATIONS COMMITTEE. I THINK HER EXPERIENCE AS A SOCIAL WORKER AND ACTIVIST PROVIDED VALUABLE LESSONS, MOTIVATION AND REALLY THE RIGHT PERSPECTIVE THAT SHE COULD DRAW ON THROUGHOUT HER TIME IN CONGRESS. SHE RETIRED FROM THE SENATE IN 2017, AND SHE IS NOW THE HOMEHOOD PROFESSOR OF POLITICAL SCIENCE AT HOPKINS, AND SHE PARTICIPATES AS A NATIONAL SPEAKER ON TOPICS OF LEADERSHIP, INNOVATION, ADVOCACY AND WOMEN'S EMPOWERMENT. THE TITLE OF HER TALK TODAY IS NIH WOMEN'S HEALTH RESEARCH, REMEMBER, REFLECT AND RECOMMIT. SO LET'S ALL WELCOME THE SENATOR. [APPLAUSE] >> HI. GOOD AFTERNOON, EVERYBODY. THANK YOU, DOCTOR, AND I'M SO GLAD TO BE BACK HERE ONCE AGAIN ON THE CAMPUS OF NIH. THE WORLD KNOWS IT AS THE NATIONAL INSTITUTES OF HEALTH, BUT DEEP IN THEIR HEART, THEY CALL IT THE NATIONAL INSTITUTE OF HOPE, BECAUSE THERE IS SO MUCH HOPE BOTH IN OUR OWN COUNTRY AND AROUND THE WORLD FOR WHAT GOES ON HERE AND WHAT GOES ON IN THE EXTRAMURAL CAMPUSES AND RESEARCH CENTERS FOR WHICH NIH DOES SUCH GREAT WORK. I'VE ALSO, IN HEARINGS WITH COLLEAGUES BACK WHEN I WAS IN THE SENATE, WE CALLED IT THE GENIUS CLUB FOR ALL THAT GOES ON HERE. SO IT'S GREAT TO BE HERE TODAY TO COMMEMORATE THE OFFICE OF WOMEN'S HEALTH, TO BE WITH FOUNDING MOTHERS, DR. PINN AND THE AMBASSADOR CONGRESSWOMAN CONNIE MORELLA. WHEN I WAS GROWING UP IN COLLEGE AND STUDYING HISTORY, I ALWAYS WONDERED WHAT DID IT FEEL LIKE TO BE PART OF A REVOLUTION, AND WHAT DID IT FEEL LIKE, YOU KNOW, TO MEET PEOPLE LIKE FOUNDING FATHERS. AND, OF COURSE, NOW WE WOULD ALSO SAY FOUNDING MOTHERS. SO YOU PICTURED POWDERED WIGS LIKE DOLLY MADISON OR BRAVE, BOLD BODACIOUS WOMEN LIKE HARRIET TUBMAN, BUT WE NEVER THOUGHT THEY'D BE CONNIE, VIVIAN, BARB, PAT, NANCY, ET CETERA. I JUST WANT TO EXPRESS MY HARDY CONGRATULATIONS FOR THEM AND ALSO ABSENT FRIENDS IN DR. HEALY AND DR. KIRRISHSTEEN, AND ALSO PEOPLE WHO WERE OUR SUPPORTERS. SENATOR KENNEDY, SENATOR NANCY CASSABELL WERE MY PALS IN THE SENATE THAT HELPED DO THIS. LATER IN MY COMMENTS, YOU'LL HEAR THE IMPORTANT ROLE THAT GOOD MEN LIKE SENATORS HARKEN AND SENATOR SENATOR SPECTER PLAYED, MEN WHO ALSO HAD TO FIGHT FOR DOUBLING THE FUNDING HERE AT NIH. BUT I WENT TO THE SENATE THE IN 1986. IN MY TIME IN CONGRESS, I FEEL LINING LIKE I'VE COME FROM A LAND FAR, FAR, FAR AWAY BECAUSE IT WAS AT A TIME WHEN THERE WAS GREAT CHANGE IN OUR COUNTRY BUT AT THE SAME TIME, WE DID WORK ON A BICAMERAL, BIPARTISAN BASIS. IT WAS HANDS ACROSS THE DOME, AND HANDS ACROSS THE AISLE, TO THEN HELPING HANDS TO WHAT WE WANTED TO ACCOMPLISH IN OUR OWN COUNTRY. MANY OF US WERE PART OF THE GREAT SOCIAL MOVEMENTS OF OUR TIME. I CERTAINLY CAME TO THE CONGRESS ON WAVE OF REFORM IN THE POST WATERGATE ERA AND ALSO ON THE WAVE OF THE WOMEN'S MOVEMENT. THERE WERE OTHERS WHO WERE COMING WHO SERVED WHO WERE ALSO IN CONGRESS, BOTH THE HOUSE AND THE SENATE, ON THE CIVIL RIGHTS MOVEMENT. GREAT PEOPLE LIKE SHIRLEY CHISHOLM, PAT SCHROEDER WHO PLAYED AN IMPORTANT PART HERE, AS DID CONGRESSWOMAN SNOW. SO THERE WAS FERMENT. THERE WAS FERMENT. AND WOMEN WERE ALSO BEGINNING TO THINK ABOUT THEIR HEALTH. THEY WERE TIRED OF HEARING THAT THEIR NATURAL PROCESSES WERE VIEWED AS A PROBLEM. A BOSTON COLLECTIVE PUBLISHED A BOOK CALLED "OUR BODY AND OUR SELVES," WHERE WOMEN ACTUALLY LOOKED AT THEMSELVES AND TALKED OPENLY ABOUT THEIR BODIES. BEGAN THE GREAT BATTLES AROUND REPRODUCTIVE FREEDOM, THE BATTLE FOR ROE VERSUS WADE, ALL OF THAT WAS THE FERMENT OF THE TIME. BUT AS WE WORK TOGETHER, WHEN I WAS IN THE CONGRESS, THERE WERE VERY FEW WOMEN IN THE SENATE THE. WHEN I WAS IN THE HOUSE AND WAS WITH CONNIE AND OLYMPIA AND PAT SCHROEDER AND OTHERS, THESE NAMES I'VE MENTIONED, WE ALL BEGAN TO ASK QUESTIONS LIKE, WHAT WAS HAPPENING WITH WOMEN IN RESEARCH? PEOPLE WERE BEGINNING TO TAKE GREAT CONCERN AND IN ALMOST AN EPIDEMIC OF BREAST CANCER AND WHAT DID THAT MEAN AND WHERE WAS THE FUNDING AND WHAT WAS GOING ON. AND THE MORE WE LOOKED AT IT, THE MORE WE SAW THAT WOMEN WERE BEING EXCLUDED FROM CLINICAL TRIALS. WE COULDN'T BELIEVE IT. WE BEGAN TO DO SOME WORK, SOME DIGGING AND SO ON. STILL, WE WEREN'T VERY HAPPY ABOUT IT. I WENT OVER TO THE SENATE, I WAS -- BACK IN 86 DAIM AND TOOK OFFICE IN 1987, AND AS WE LOOKED AT IT, WE BEGAN TO COMMISSION THINGS LIKE THE GAO REPORT SO WE WOULD HAVE OUR FACTS AND FIGURES TO BE ABLE TO ARGUE BECAUSE WE WANTED TO BRING ABOUT CHANGE. WELL, WHAT DID WE FIND OUT? WE FOUND OUT FIRST OF ALL THERE WAS THE FAMOUS TAKE AN ASPIRIN ASPIRIN A DAY, WEEP A HEART ATTACK AWAY, AMONG MALE RESIDENTS AND NOT ONE WOMAN. THERE WERE THE FAMOUS LONGITUDINAL STUDY ON AGING, AGAIN, ALL MEN, NO WOMEN, AND AS I REMARKED TO MY FRIEND TED KENNEDY, I SAID, YOU KNOW, TAKE A LOOK ACROSS THE AISLE, STROM THURMOND AND I AGE A LITTLE BIT DIFFERENTLY. [LAUGHTER] HIS COMMENTS WERE, [I WOULD HOPE SO, BARB." BUT AGAIN, WE WENT TO WORK AND FOUND THAT IN 1989, CLINICAL TRIALS OF NEW DRUGS NOT ONLY WERE WE EXCLUDED FROM THE RESEARCH TO FIND CURES, TO BE ABLE TO WORK ON CONTAINMENT OF THE ESCALATION OF CHRONIC CONDITIONS LIKE DIABETES, CARDIOVASCULAR DISEASE. WE ALSO FOUND THAT WE WERE JUST EXCLUDED. WE FOUND THAT IN TERMS OF PRESCRIPTIONS, BECAUSE WE WEREN'T INCLUDED IN THE ORIGINAL RESEARCH, THAT ANYTHING ON DRUGS AS THEY WERE GETTING READY FOR SAFETY AND ADVOCACY RESEARCH, THAT WE AGAIN WERE SYSTEMATICALLY EXCLUDED. SO FINALLY, IT GOT TO BE A LITTLE BIT OF A BOILING POINT. IN 1991, THERE WAS THE YEAR OF THE WOMAN. THE DEBACLE OF ANITA HILL ON CAPITOL HILL LED TO MANY NEW WOMEN BEING ELECTED TO THE ?A. AT THE SAME TIME, THE HOUSE WAS FEELING THE SAME SURGE OF WOMEN'S POWER. AND WE GOT TOGETHER, THE CONGRESSWOMEN'S CAUCUS OVER THERE, THE WOMEN OF THE SENATE THE, AND WE ASKED FOR A GAO REPORT, THE GOVERNMENT ACCOUNTING OFFICE. WE FOUND OUT LESS THAN HALF OF THE PRESCRIPTION DRUGS ON THE MARKET HAD BEEN ANALYZED FOR GENDER-RELATED RESPONSE DIFFERENCES. WE FOUND OUT THAT WHERE MEDICAL RESEARCH WAS BEING DONE, THAT IT JUST WASN'T HAPPENING FOR WOMEN. SO FINALLY, AFTER WE FOUND OUT WE WERE BEING EXCLUDED FROM TRIALS, AND NOT GETTING VERY FAR FAR, THERE WAS A FAMOUS LETTER THAT WAS WRITTEN. AUGUST 22ND, 1990, IT WAS SIGNED BY CONGRESSWOMAN PAT SCHROEDER, BY CONGRESSWOMAN OLYMPIA SNOW, WHO SENDS HER REGARDS TODAY, CONGRESSWOMAN CONNIE MORELLA, WHO TOOK A VERY BOLD AND BODACIOUS STAND. SHE HERSELF REPRESENTING NIH, AND WAS ABOUT TO CHALLENGE THE THINKING HERE, MANY OF WHOM WERE HER GREAT VOTERS, AND I MIGHT ADD, SOME FOR ME TOO, AND WITH THE SUPPORT OF SENATOR NANCY CASSEBAUM, WE SENT A LANDMARK LETTER TO THE ACTING DIRECTOR REQUESTING A PUBLIC MEETING TO DISCUSS HOW BEST TO IMPROVE FEDERAL RESEARCH ON WOMEN'S HEALTH. WE ASKED AT THAT TIME THAT ALL 12 NIH INSTITUTE DIRECTORS BE THERE, AND THEIR LEADERSHIP TEAM, AND WHAT WE WANTED TO KNOW WAS, INSTITUTE BY INSTITUTE BY INSTITUTE, WHERE WERE WOMEN BEING INCLUDED, AND IF WE WERE BEING EXCLUDED, WHAT WAS THE SCIENTIFIC BASIS FOR IT? WELL, WE HEARD INTERESTING THINGS, LIKE THE NATIONAL INSTITUTES OF AGING SAID, WELL, WE COULDN'T DO RESEARCH WITH WOMEN, THERE WAS NO LADIES ROOM WHERE WE DID IT. IN THE MEANTIME, WHILE WE WERE ALSO WORKING ON THIS, I MEAN, THE REASONS WERE RIDICULOUS. BUT WE HAD SOMEONE WHO WAS A GREAT ADVOCATE THERE BY THE NAME OF RUTH KIRSCHSTEIN. NOW AS WE PULLED UP THAT DRAMATIC DAY BECAUSE WE MADE A VERY BIG DEAL, CONNIE AND I ARE FROM THE SCHOOL OF THOUGHT WHICH IS IF YOU DON'T GET PRESS, IT DIDN'T HAPPEN. AND AS WE PULLED UP IN OUR CAR, GEORGE HERBERT WALKER BUSH ANNOUNCED THE APPOINTMENT OF BERN DEAL HEALY TO BERNADINE HEALY TO BE THE DIRECTOR OF NIH. I WORKED WITH DR. HEALY TO GET HER CONFIRMED IN THE SENATE. WE KNEW THAT SHE WOULD BE A GREAT ASSET TO US, AND THEN WE TALKED ABOUT THE OFFICE OF WOMEN'S HEALTH AND SHE SAYS, THERE IS A GREAT SCIENTIST ALREADY AT NIH WHO'S BEEN WORKING ON THIS ISSUE FOR YEARS, DR. RUTH KIRSCHSTEIN, AND WE'RE READY TO GO. SO WE WORKED BY EXECUTIVE ORDER AND MANDATE IN THE APPROPRIATIONS COMMITTEE BECAUSE THERE WAS GREAT PUSHBACK, GREAT, GREAT PUSHBACK FROM THE SCIENTIFIC ESTABLISHMENT THAT EGGED ON THE GUYS IN THE POLITICAL ESTABLISHMENT TO OPPOSE IT. SO WE SETTLED FOR LANGUAGE IN APPROPRIATIONS AND SO ON THAT ESTABLISHED THE OFFICE OF RESEARCH ON WOMEN'S HEALTH. AND WITH THE SUPPORT OF SENATORS HARKEN, AND SPECTER, WE WERE ABLE TO DO IT. ENSURING THAT WOMEN WOULD BE INCLUDED IN CLINICAL RESEARCH, IT WOULD SET RESEARCH PRIORITIES AND IT WOULD PROMOTE THE BIOMEDICAL RESEARCH CAREERS FOR WOMEN. THAT IF YOU'RE GOING TO HAVE WOMEN DOING THE RESEARCH, YOU HAVE TO PROMOTE THE PIPELINE. AND UNDER DR. HEALY'S GUIDANCE, IT REALLY CAME ALIVE WITH THE APPOINTMENT OF DR. PINN, AND THEN BEGAN TO MOVE ON IT. WE ALSO KNEW IT NEEDED AN ADVISORY BOARD. WE KNEW ABOUT ADVISORY BOARDS. THE POWER LIES IN WHO APPOINTS. SO SHOULD IT BE THE WHITE HOUSE? [LAUGHTER] SHOULD IT BE THE SPEAKER OF THE HOUSE AND THE LEADER OF THE SENATE? SO AGAIN, WORKING HANDS ACROSS THE AISLE, HANDS ACROSS THE DOME, WE SAID IT SHOULD BE APPOINTED BY THE DIRECTOR OF NIH. SO YOU'RE HERE NOT BECAUSE OF BARACK OBAMA OR DONALD TRUMP OR WHOEVER IS GOING TO COME IN THE FUTURE. YOU'RE HERE BECAUSE OF THE DIRECTOR OF NIH, AND WERE TO BE CHOSEN BECAUSE OF YOUR SCIENTIFIC LEADERSHIP AND YOUR SCIENTIFIC KNOW-HOW BECAUSE YOU ARE LEADERS, BECAUSE YOU ARE INNOVATORS, AND BECAUSE YOU DARE TO TAKE WOMEN'S RESEARCH WHERE IT HAS NOT GONE BEFORE. SO THAT'S HOW WE WORK TOGETHER ON THAT. YOU WANT TO CLAP ON THAT? I'M GONNA CLAP FOR YOU. [APPLAUSE] ALONG THE WAY, BECAUSE DR. HEALY AND I HAVE TALKED A GOOD BIT, AND SHE'D COME FROM HOPKINS. NOW HOPKINS, SOME DOCTORS AT HOPKINS HAD NOT BEEN FRIENDLY TO WOMEN'S RESEARCH. AND DR. PINN CAN TALK ABOUT DR. MINER, WHO RESISTED HER, BUT IN A HEARING IN THE SENATE, DR. EDGAR BERMAN CAME AND TESTIFIED, AND HE SAID, ABSOLUTELY NOT, WOMEN SHOULD NOT BE INCLUDED IN THE PROTOCOLS BECAUSE WOMEN HAVE RAGING HORMONES. SENATOR KENNEDY PUT DOWN THE GAVEL AND LOOKED AT ME, AND I SAID, DR. BERMAN, YES, WE DO HAVE RAGING HORMONES, AND IT'S BECAUSE OF GUYS LIKE YOU. [LAUGHTER] SENATOR KENNEDY SAID, AS CHAIR ALSO THE RANKING REPUBLICAN WITH SENATOR CASSENBAUM, HE SAID, DULY NOTED. I SAY THAT, THOUGH, BECAUSE THERE WAS SUCH RESISTANCE. THERE HAD BEEN A FAMOUS STUDY BY THE RAND CORPORATION OF ALCOHOLISM AND THE UTILIZATION OF SERVICES. THEY STUDIED WOMEN AND THEY STUDIED MEN AND WOMEN, AND WHEN THEY LOOKED AT THE RESEARCH, THEY FOUND THAT WOMEN -- THERE WERE DIFFERENT METRICS AND ALL THAT WERE EMERGING, AND THEY DECIDED THAT WOMEN WERE DEVIANT. THAT WAS THE WORD THAT THEY USED AND THREW OUT ALL OF THAT RESEARCH. WELL, IT WAS NOT TO BE HAD WITH DR. HEALY AND DR. KIRSCHSTEIN AND ALSO THE OTHER DIRECTORS OF THE INSTITUTES. ABOUT HEALY THEN CALLED ME AND SAID, SENATOR MIKULSKI, THERE'S BEEN A LOT OF DISCUSSION IN THE SCIENTIFIC COMMUNITY ABOUT WHAT HORMONE REPLACEMENT THERAPY MEANS. AND I WOULD LIKE TO DO A LONGITUDINAL STUDY. NOW, I'VE GOT TO GET THROUGH OMB, I'VE GOT TO GET THROUGH DAVID STOCKMAN, I'VE GOT TO GET THROUGH EVERYBOD. WHAT DO YOU THINK YOU COULD ADVISE ME? AND I SAID, WELL, FIRST OF ALL, DR. HEALY, WE'RE NOT GOING TO GIVE YOU AN EARMARK, BECAUSE THOUGH I BELIEVE IN EARMARKS, WE HAD THEM BACK IN THE DAY, CONNIE CONNIE, I SAID YOU DO NOT WANT POLITICIANS SETTING THE PRIORITIES FOR RESEARCH. YOU MIGHT GET IT WITH ME TODAY, BUT THERE MIGHT BE SOMEBODY ELSE TOMORROW. THIS IS NOT OUR AREA OF EXPERTISE, AND SO ON. BUT I SAID I WANT TO TALK TO HARKEN AND SPECTER. SENATOR HARKEN WAS CHAIRING THE APPROPRIATE RANGE OF APPROPRIATIONS, SENATOR SENATOR SPECTER WAS THE RANKING. IF THE POLITICAL POWER SHIFTED, THEY EASILY WENT BACK AND FORTH. AND I TOOK MY PROBLEM TO THEM, BECAUSE I BELIEVE THEN AS I BELIEVE NOW AND I'M SURE MANY EXPERIENCED IN THIS ROOM, MEN OF QUALITY ALWAYS SUPPORT WOMEN WHEN THEY SEEK EQUALITY. AND I CANNOT SAY ENOUGH ABOUT SENATORS HARKEN AND SPECTER. THEY SAID, LET'S PUT OUR THINKING ON, BARBARA. IF DR. HEALY THINKS IT'S A GOOD IDEA AND THE SCIENTIFIC COMMUNITY THINKS, LET'S THINK ABOUT THIS. WE AGREE. WE AGREE. DO NOT LET US SET THE PRIORITIES. BECAUSE WHAT'S IT GOING TO BE TODAY, WHAT'S IT GOING TO BE TOMORROW? THEY CAME BACK AND SAID SAT FOR A LITTLE COFFEE TO TALK ABOUT THIS. THEY SAID, WE HAVE A SUGGESTION FOR YOU. AND THEY MET TOGETHER. CAN YOU IMAGINE THAT, CONNIE, TODAY? THEY ACTUALLY WERE IN THE SAME ROOM TOGETHER WITH THEIR STAFF. AND WHAT THEY SAID TO ME WAS, WE'RE GOING TO SUGGEST THAT WE ESTABLISH A FUND FOR INNOVATIVE RESEARCH TO BE DECIDED BY THE DIRECTOR OF ANY. IF THERE WAS PROMISING RESEARCH THAT WOULD BE INNOVATIVE, THE DIRECTOR COULD SO MOVE IT. WE HELP CREATE THAT FUND, THAT'S WHERE DR. HEALY GOT THE INITIAL MIN MILLIONS TO MILLIONS TO START THAT RESEARCH. WELL, YOU ALL KNOWS A SCIENTISTS WITH ALL THAT YOU'VE DONE HERE IN THIS OFFICE OF WOMEN'S HEALTH WHAT THAT RESEARCH DID. WHEN I HAD THE OPPORTUNITY TO TALK TO DR. HEALY WHEN SHE WAS NOT WELL, AND THE DAYS WERE STARTING -- THE FINAL DAYS WERE COMING NEAR, AND I CALLED HER AND I SAID, BERNADINE, I DON'T KNOW IF YOU'VE HAD A CHANCE TO READ "THE TIMES" TODAY, BUT IT SAYS ALL OF THE REPORTS ARE INDICATING THAT THAT RESEARCH THAT WE DID HAS LOWERED BREAST CANCER RATES IN THIS COUNTRY BY 15%. IT HAS AFFECTED MEDICAL PRACTICE. AND SHE SAID, BARBARA, THINKING BACK TO MY YOUNG DAYS AT HOPKINS, DO YOU REMEMBER THE SLOGAN OF THE SCHOOL OF PUBLIC HEALTH? AND I SAID, OH, SURE. SHE SAID, WE SAVE LIVES A MILLION AT A TIME. WELL, I CAN'T TALK ANY MORE ABOUT IT. THAT WAS THE LAST CONVERSATION I EVER HAD WITH HER. AND THAT'S WHAT WE TALKED ABOUT. NOW TO THIS DAY, I DON'T KNOW IF DR. HEALY WAS A DEMOCRAT OR A REPUBLICAN. BUT WHO CARES? RIGHT? WHO CARES. LOOK AT SPECTER AND HARKEN, MORELLA AND MIKULSKI. WE WERE ALL IN IT TOGETHER, AND THAT'S THE WAY WE NEED TO BE. I BELIEVE THAT AMERICA IS A GREAT COUNTRY. WE DON'T HAVE TO MAKE IT GREAT AGAIN. WE ARE A GREAT COUNTRY. BUT WE ARE GREAT -- [APPLAUSE] WE ARE GREAT WHEN WE WORK TOGETHER. THE MARINES HAVE A GREAT SAYING: BE BEST AT WHAT YOU'RE BEST AT, AND BE BEST AT WHAT YOU'RE NEEDED FOR. IT WAS OUR JOB AS ELECTED OFFICIALS TO HELP YOU BE YOU, TO CREATE AN ORGANIZATIONAL EFFORT TO GET THE FUNDING BEHIND IT AND LET YOU BE YOU. AND HERE TODAY AS WE COMMEMORATE THIS GREAT OFFICE AND THIS GREAT INSTITUTION, THAT'S WHAT WE'RE HERE TO BE FOR YOU. WE WANT YOU TO GO WHERE THE SCIENCE TAKES YOU, UNFETTERED, UNCENSORED, BUT NEVER UNFUNDED. GOD BLESS YOU, AND MAY THE FORCE BE WITH YOU. [APPLAUSE] >> THANK YOU VERY MUCH, SENATOR MIKULSKI, FOR THAT ROUSING HISTORY -- HISTORICAL PERSPECTIVE AND FOR THOSE INSPIRATIONAL COMMENTS. WE GREATLY APPRECIATE THIS DYNAMIC TRIO THAT SHARED WITH US THEIR PERSPECTIVES. THANK YOU VERY MUCH, LADY. [APPLAUSE] I ALSO WANT TO ACKNOWLEDGE SOME OTHER GUESTS THAT HAVE JOINED US, DR. DIANA BIANCHI SITTING TO MY LEFT, THE DIRECTOR OF THE EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT, DR. WALTER KOROSHETZ, THE DIRECTOR OF NINDS, AND I BELIEVE THERE'S ONE MORE PERSON, ANNE C ASHIN, ACTING DIRECTOR OF THE NURSING INSTITUTE. THANK YOU FOR JOINING US. [APPLAUSE] SO NOW I'LL ASK DR. DENISE FREDERICK TO INTRODUCE OUR NEXT SPEAKERS. >> SO I DON'T KNOW IF ANYBODY IS AS EXCITED AS I AM AFTER HEARING THESE THREE WOMEN SPEAK. I FEEL LIKE I'M JUST SO ENERGIZED. [APPLAUSE] IF I DIDN'T THINK I'D LOSE MY JOB, I'D GO RUN OUT THE DOOR AND DO SOMETHING FOR WOMEN'S HEALTH. SETTLE DOWN, DENISE. MY NAME IS DENISE, AND IT'S BEEN SUCH A PRIVILEGE TO BE ABLE TO WORK WITH MARGARET BEVANS AND MANY OF YOU IN THIS ROOM ON THE DEVELOPMENT OF THE TRANS-NIH STRATEGIC PLAN WOMEN'S HEALTH RESEARCH. SO I'M HERE TODAY, I'M SUPPOSED TO RIGHT NOW INTRODUCE YOU GUYS, INTRODUCE THE NEXT SPEAKERS, BUT I'M GOING TO TAKE A MOMENT TO GIVE A CONFESSION. SO MY ORWH COLLEAGUES ARE LIKE, OH, HERE WE GO AGAIN. YEAH, HERE WE ARE. BUT I AM GOING TO GET TO THE POINT EVENTUALLY. SO MY CONFESSION IS THAT BEFORE I CAME TO THIS OFFICE, I DID NOT KNOW ANYTHING ABOUT WOMEN'S HEALTH. I KNEW VERY LITTLE ABOUT WOMEN'S HEALTH AND I KNEW NOTHING ABOUT THE HEALTH OF WOMEN. NOTHING AT ALL. AND THAT'S -- BEING HERE, I HAVE LEARNED A LOT. AND SO WHAT I LIKE ABOUT THIS PLAN, WHAT IS SO IMPORTANT ABOUT THIS PLAN IS THAT I'M SURE I'M NOT THE ONLY PERSON WHO'S IN THAT SITUATION. I THINK THAT THERE ARE PLENTY OF PEOPLE, THEY MAY BE LAY PEOPLE BUT THEY MAY BE SCIENTISTS AND HEALTH PROFESSIONALS THAT DON'T KNOW ANYTHING ABOUT THE HEALTH OF WOMEN AND THAT'S A TRAGEDY. SO THAT IS WHY I PERSONALLY AM EXCITED ABOUT THIS STRATEGIC PLAN. SO I AM HONORED AND EXCITED TO INTRODUCE DR. MARGARET BEVANS AND DR. JANINE CLAYTON, AND THEY'RE GOING TO TALK TO YOU ABOUT THE PROCESS THAT WE WENT THROUGH TO DEVELOP THIS PLAN AND THEY'RE GOING TO GIVE YOU SOME HIGHLIGHTS ON THE PLAN. SO COME ON UP, LADIES. THANK YOU. >> WELL, I'M NOT QUITE SURE HOW I'M GOING TO TALK, AGAIN, FOLLOWING THE WONDERFUL PRESENTATION FROM THESE WOMEN. IT'S SUCH AN HONOR TO BE HERE TODAY AND I AM JUST COMPLETELY HUMBLED TO BE BEHIND THIS MICROPHONE TO SHARE WHAT I BELIEVE IS AN AMAZING PIECE OF WORK WITH ALL OF YOU. SO BEFORE I SHARE WITH YOU THE PROCESS TAKEN BY NIH TO DEVELOP THE NEW STRATEGIC PLAN FOR WOMEN'S HEALTH RESEARCH, WE NEED TO FIRST CONTINUE TO ACKNOWLEDGE THAT THIS FRAMEWORK IS BUILT UPON THE STRATEGIC PLAN THAT CAME BEFORE US. MY YA ANGLO RECOGNIZED YOU CAN'T REALLY KNOW WHERE YOU'RE GOING UNTIL YOU KNOW WHERE YOU HAVE BEEN, AND WE CAN'T AGREE ANY MORE. SINCE 2010, THE NIH HAS BEEN THE STEWARD OF TREMENDOUS SCIENTIFIC ADVANCES THAT HAVE IMPROVED THE HEALTH OF WOMEN. THESE ADVANCES HAVE OCCURRED IN MANY AREAS OF HEALTH AND DISEASE, SPANNING THE INDIVIDUAL INSTITUTES AND CENTERS HERE AT THE NIH. WE ARE ESPECIALLY PLEASED TO HAVE DR. VIVIAN PINN HERE WITH US TODAY, WHO LED THE DEVELOPMENT OF THE PREVIOUS STRATEGIC PLAN, WHICH SERS AS SERVES AS THE FOUNDATION FOR THE PLAN WE'RE SHARING WITH YOU TODAY. THERE HAS BEEN SINCE THEN INCREASED ATTENTION TO THE INCLUSION OF PREGNANT WOMEN IN CLINICAL RESEARCH, AN INCREASE IN RESEARCH THAT EXAMINES THE INFLUENCES OF SEX AND GENDER ON HEALTH AND DISEASE, ALSO KNOWN AS SEX DIFFERENCES RESEARCH. WE HAVE SEEN NEW POLICIES SUCH AS ENHANCING REPRODUCIBILITY THROUGH RIGOR AND TRANSPARENCY, AND THE POLICY OF SEX AS A BIOLOGICAL VARIABLE. A MAJOR STEP TOWARD UNDERSTANDING HOW TO IMPROVE THE HEALTH OF WOMEN. THESE ADVANCES AND MANY MORE HAVE LAID THE GROUNDWORK FOR THE NIH TO CONTINUE MAKING ADVANCES IN THE NEXT FIVE YEARS. SO HOW DID WE GET HERE TODAY? THE ORWH TOOK A MULTI-RESOURCE ITERATIVE APPROACH TO STRATEGIC PLANNING WITH A STRONG FOCUS ON STAKEHOLDER INPUT. THE DEVELOPMENT OF THE NEW TRANS-NIH STRATEGIC PLAN FOR WOMEN'S HEALTH RESEARCH BEGAN WITH ORWH'S EFFORTS TO MINE DATA FROM MULTIPLE SOURCES AND IDENTIFY IMPORTANT TOPICS THAT REQUIRED ATTENTION TO ACTUALLY IMPROVE THE HEALTH OF WOMEN. FEEDBACK WAS SOUGHT FROM RESEARCHERS AND HEALTHCARE PROVIDERS ATTENDING CONFERENCES FOCUSED ON WOMEN'S HEALTH AS WELL AS MANY MEMO WE MEMBERS OF FORMAL NIH WORKING GROUPS AND COMMITTEES. THESE GROUPS ARE LISTED HERE ON THE SLIDE AND INCLUDE THE ORWH STRATEGIC PLAN ORGANIZATIONAL TEAM, THE TRANS-NIH SEX AS A BIOLOGICAL VARIABLE WORKING GROUP, THE NIH COORDINATING COMMITTEE OF RESEARCH -- FOR RESEARCH ON WOMEN'S HEALTH, ALSO KNOWN AS THE CCRWH, THE NIH ADVISORY COMMITTEE FOR RESEARCH ON WOMEN'S HEALTH, ALL OF YOU HERE WITH US TODAY, AND THE NIH RAISING THE BAR WORKING GROUP. AND I JUST WANT TO SPEND A MINUTE TALKING ABOUT THAT WORKING GROUP FOR A SECOND. THE RAISING THE BAR WORKING GROUP WAS ESTABLISHED IN RESPONSE TO THE 2013 SHORTER LIVES POORER HEALTH REPORT BY THE THEN INSTITUTE OF MEDICINE. THE FINDINGS OUTLINED IN THIS REPORT REVEALED THAT THE U.S. WAS RANKED LOWEST IN LIFE EXPECTANCY COMPARED TO OTHER PEER COUNTRIES, ESPECIALLY AMONG U.S. WOMEN. IN RESPONSE TO THAT REPORT IN 2015, THE OFFICE OF RESEARCH ON WOMEN'S HEALTH LED BY THE RAISING THE BAR WORKING GROUP AND IN COLLABORATION WITH THE NATIONAL ACADEMIES CONVENED A WORKSHOP ENTITLED "IMPROVING THE HEALTH OF WOMEN IN THE U.S. THE FINDINGS OF THAT MEETING ALONG WITH A SERIES OF FOCUSED ANALYSES THAT FOLLOWED COMPLETED BY THE RAISING THE BAR WORKING GROUP INFORMED THE STRATEGIC PLANNING PROCESS THAT WE'RE TALKING ABOUT TODAY, AND THE DEVELOPMENT OF WHAT WE CALL A REQUEST FOR INFORMATION. THE REQUEST FOR INFORMATION WAS AVAILABLE FOR PUBLIC COMMENT FOR APPROXIMATELY 60 DAYS. THE OBJECTIVE OF WHAT WE CALL AN RFI WAS TO SOLICIT INPUT ON THE INITIAL THEMES AND GOALS, CROSS CUTTING BASIC CLINICAL AND TRANSLATIONAL SCIENCE, INCLUDING FROM ADVOCACY AND PATIENT COMMUNITIES WITH KEY STAKES IN WOMEN'S HEALTH RESEARCH. THE NOTICE WAS WIDELY DISTRIBUTED AND GENERATED 145 INDIVIDUAL RESPONSES, A NEW BENCHMARK FOR THE OFFICE OF THE DIRECTOR. THE RESPONSES REPRESENTED NIH INSTITUTES, CENTERS AND OFFICES. OUR DHHS PARTNERS SUCH AS THE CDC AND SAMHSA, UNIVERSITIES, MANY WHO ARE HERE TODAY, AND WHO HAVE SPECIFIC INSTITUTES FOR WOMEN'S HEALTH RESEARCH. SOCIETIES SPECIFIC TO WOMEN'S HEALTH AS WELL AS SOCIETIES FOR CONDITIONS AND DISEASES, SCHOOLS OF MEDICINE, PUBLIC HEALTH AND NURSING, AND INDUSTRY AND ADVOCACY GROUPS. ALL OF THIS INPUT CAME IN AND WAS CAREFULLY ASSESSED TO IDENTIFY THEMES THAT YIELDED 45 INDIVIDUAL CATEGORIES. YOU GUYS ALL LOVE DATA, RIGHT? SO THIS WORD CLOUD THAT YOU SEE HERE REPRESENTS THE MOST COMMON CATEGORIES THAT WERE GENERATED FROM THE RESPONSES. THE LARGER WORDS SUCH AS PREGNANCY AND DISPARITIES REPRESENT THEMES MORE FREQUENTLY REPRESENTED IN THE FEEDBACK. THE 45 THEMES WERE THEN REVIEWED AND DISTILLED INTO FIVE STRATEGIC GOALS THAT SERVE AS THE FOUNDATION FOR THE OBJECTIVES OUTLINED IN THIS PLAN. FOR EXAMPLE, MANY THEMES RELATED TO CONDITIONS AND DISEASES SUCH AS CARDIOVASCULAR DISEASE, CANCER, SLEEP, AND PREGNANCY, WHICH REPRESENT THE KEY TOPICS OF IMPORTANCE TO WOMEN'S HEALTH, AND INFORMED OUR FIRST AND ULTIMATE GOAL RELATED TO RESEARCH. OTHER THEMES WERE GROUPED TO INFORM GOALS FOCUSED ON METHODS, TRAINING AND CAREERS, DISSEMINATION, AND EVALUATION. ANOTHER SET OF THEMES WERE VERY CROSS CUTTING, SUCH AS DISPARITIES, LIFE COURSE, INTERDISCIPLINARY AND SABV. AND THESE THEMES LED TO WHAT WE CALL OUR GUIDING PRINCIPLES THAT INFORM ALL RESEARCH EFFORTS TO ADVANCE THE SCIENCE FOR THE HEALTH OF WOMEN. REFINING THE PLAN CONTINUED WITH ENGAGEMENT ACROSS THE NIH IN ADDITION TO OUR EXTERNAL STAKEHOLDERS, MANY OF WHOM ARE MEMBERS OF THIS ADVISORY COMMITTEE. AND I HOPE ACTUALLY MANY STAKEHOLDERS WHO ARE ALSO ON THE PHONE TODAY JOINING US. AT THE NIH, DR. CLAYTON PRESENTED TO THE NIH COUNCIL OF COUNCILS IN JANUARY OF 2018. SHE COMMUNICATED WITH ALL 27 INSTITUTE AND CENTER DIRECTORS AND MET WITH 23 I.C.s SPECIFICALLY, 18 SPECIFICALLY WITH THOSE DIRECTORS. SHE ALSO MET WITH MANY DIRECTORS FROM RELEVANT OFFICES IN THE OFFICE OF THE DIRECTOR, AND HER MOVEMENT THROUGH THE AGENCY IN THE LAST YEAR HAS REALLY EARNED HER A SUPERSTAR BADGE ON HER FITBIT, OR IPHONE OR WHATEVER EVERYBODY IS WEARING ON THEIR WRISTS THESE DAYS. PRETTY IMPRESSIVE. IN ADDITION IN COLLABORATION WITH THE COORDINATING COMMITTEE FOR RESEARCH ON WOMEN'S HEALTH, THE NIH STRATEGIC PLAN TEAMS WERE FORMED BASED ON THE FIVE INITIAL GOALS. THIS WORK, THE WORK OF THESE FIVE TEAMS STARTED WITH TWO HUGE THINK TANK SESSIONS EARLIER THIS YEAR. THE FIVE TRANS-NIH STRATEGIC PLAN TEAMS COLLABORATED TO DEVELOP THE FINAL GOALS AND OBJECTIVES YOU WILL SEE PRESENTED TODAY. EACH TEAM WAS CO-LED BY A STAFF MEMBER FROM THE ORWH AND STAFF FROM THE INSTITUTES, CENTERS AND OFFICES. THE FIVE TEAMS INCLUDED 102 INDIVIDUAL STAFF REPRESENTING 22 OF THE INSTITUTES AND CENTERS AND MULTIPLE OFFICES OF THE OFFICE OH OF THE OFFICE OF THE DIRECTOR. SO I WANT TO GIVE A SPECIAL SHOUTOUT TO ALL OUR COLEADS SEEN HERE ON THE SLIDE. FROM ORWH, FROM THE LEFT TO RIGHT, BEGINNING AT THE TOP, DRS. GIMM, REBECCA WIGGINS, DENISE, AND FROM OUR IC PARTNERS MARGARET FERRELL FROM THE NCI, SARAH FROM THE INIR, CAROL LUND FROM OER, Z. NIA FROM NHLBI, KATIE MORRIS FROM OBSSR, AND LISA HALVERSON FROM NICHD. MUCH GRATITUDE TO ALL OF YOU FOR YOUR EXTRA WORK TO GET US OVER THE FINISH LINE. CONTINUING WITH OUR SHOUTOUTS, WE NEED TO RECOGNIZE THE CONSISTENT AND CRITICAL ENGAGEMENT OF THE MEMBERS OF OUR COORDINATING COMMITTEE FOR RESEARCH ON WOMEN'S HEALTH, REPRESENTING ALL 27 INSTITUTES AND CENTERS AND RELEVANT OFFICES OF THE OFFICE OF THE DIRECTOR. THIS WAS A VERY BUSY YEAR FOR THIS COMMITTEE WITH SIGNIFICANT MEMBERSHIP CHANGES DRIVEN BY THE 21ST CENTURY CURES WHICH REQUIRED THAT THIS GROUP BE COMPOSED OF THE I.C. DIRECTORS OR THEIR SENIOR LEVEL DESIGNEES. THEREFORE, WE WANT TO ACKNOWLEDGE THE CRITICAL INPUT AND SUPPORT FROM OUR 2017 COMMITTEE AS WELL AS THE CURRENT COMMITTEE AND LOOK FORWARD TO THE ROLE AS AGENTS IN THE IMPLEMENTATION OF THIS PLAN. AND LAST BUT MOST DEFINITELY NOT LEAST, A SPECIAL SHOUT OUT TO OUR ACRWH MEMBERS, SPECIFICALLY THE STRATEGIC PLAN WORKING GROUP, FOR THEIR COMMITMENT TO THIS PROCESS OVER THE LAST TWO YEARS. THEY REPRESENTED MANY DISCIPLINES AND INCREDIBLE DEPTH AND BREADTH OF NONL AND A WORK KNOWLEDGE A ND A WORK ETHIC AND COMMITMENT WE ARE INCREDIBLY GRATEFUL FOR. SO AT THIS TIME, I'D LIKE TO INTRODUCE DR. CAROLYN MAZURE WHO WOULD LIKE TO SUMMARIZE CONTRIBUTIONS AND THEIR ROLE IN THIS PROCESS. >> THANK YOU, DR. BEVANS. IT'S A GREAT PRIVILEGE TO BE HERE AS PART OF THIS COMMITTEE AND PART OF THIS WORKING GROUP. TODAY WHAT I'D LIKE TO DO IS COVER JUST A FEW POINTS VERY QUICKLY. I JUST WANT TO MENTION TO YOU THE IMPORTANT POINT THAT THE PROCESS THAT WAS ENGAGED IN THIS EFFORT WAS TRULY A BROAD PROCESS AND IT INVOLVED THE FULL COMMITTEE AND INVOLVED THE WORKING GROUP. AS DR. BEVANS INDICATED, IT WAS AN ITERATIVE PROCESS AMONG LOT OF DIFFERENT INDIVIDUALS, AND THE COMMITTEE AND THE WORKING GROUP WERE BOTH VERY RESPONSIVE TO THE FEEDBACK WE RECEIVED FROM THE NIH AS WELL AS ALL OTHERS. IN TERMS OF THE PLAN THAT THEN IS GOING TO BE PUT FORWARD, IT'S A PLAN AS YOU'LL SEE HAS CROSS CUTTING THEMES, VERY IMPORTANTLY, AND IT PROVIDES GOALS AND OBJECTIVES AND AS SENATOR MIKULSKI SAID AT LUNCH, SHE IS A PROFESSOR OF PRACTICE AND PRODUCTS, AND SO THIS PLAN, TOO, WILL HAVE PRACTICE AND PRODUCTS INCLUDED. FINALLY, I THINK IT'S IMPORTANT TO SAY, BEFORE WE TURN TO THE COMMITTEE AGAIN, THAT THE NIH HAS A COMMITMENT TO THE HEALTH OF WOMEN AS A FUNCTION OF THE EXPERIENCE OF THIS PROCESS, AND THAT IS THANKS TO THE PEOPLE WHO CAME BEFORE US AS WELL AS THIS OFFICE HERE, DR. CLAYTON AND EVERYONE WHO HELPS IN THIS PROCESS INCLUDING THE COMMITTEE, THE WORKING GROUP, AND ALL OF THE PEOPLE WITHIN THE NIH WITH WHOM DR. CLAYTON HAS INTERACTED. SO WE THANK YOU ALL FOR THAT. WE WILL MENTION AS WELL THAT THE BREADTH OF DISEASES AND CONDITIONS THAT AFFECT THE HEALTH OF WOMEN ACROSS THE LIFE COURSE ARE INCLUDED IN THESE CUTTING THEMES, AND THAT IS IN RESPECT TO THE DIFFERENT INSTITUTES AND CENTERS THAT WANT VARIOUS KIND OF CONDITIONS REPRESENTED, AND IT ALSO INCLUDES THE IMPORTANCE OF CONSIDERING DIFFERENT DISCIPLINES AS WELL. SO WE'RE EXCITED TO SUPPORT THE NEXT STEPS, THE IMPLEMENTATION OF THIS PARTICULAR STRATEGIC PLAN, AND AT THIS JUNCTURE, I WANT TO SAY THAT THE ADVISORY COMMITTEE IS POISED TO SUPPORT THE PLAN, THE EFFECTIVE DISSEMINATION OF THE PLAN, THE EVALUATION AND IMPLEMENTATION WITHIN AND AMONG THE INSTITUTES, AND CENTERS. SINCE WE AS A COMMITTEE ARE BRINGING THE DEVELOPMENT OF THE STRATEGIC PLAN TO A CLOSE AT THIS JUNK TEU I WOULD JUNK TEU I WOULD LIK E TO MAKE A MOTION TO CLOSE THE ADVISORY COMMITTEE FOR THE OFFICE OF WOMEN'S HEALTH STRATEGIC PLAN WORKING GROUP, AND WE WILL FOCUS THEN AS A FUNCTION OF THAT ON THE DEVELOPMENT OF THE STRATEGIC PLAN, AND SO I THINK AT THIS JUNCTURE, I'LL STEP DOWN AND DR. CLAYTON W ILL CALL FOR THE VOTE. >> SO IS THERE A SECOND FOR THIS MOTION? MOTION NOTED. THERE IS A VOTE ON THE TABLE, THEN, TO CLOSE THE GROUP. MAY I HEAR AYES TO AGREE? NAYS? MOTION IS ACCEPTED. THANK YOU. >> THANK YOU, DR. MAZURE, AND THANK YOU, DR. BEVANS. IT'S MY HONOR TODAY TO PRESENT TO YOU THE GUIDING PRINCIPLES AND THE GOALS AND OBJECTIVES OF THE NEW TRANS-NIH STRATEGIC PLAN FOR WOMEN'S HEALTH RESEARCH, ADVANCING SCIENCE FOR THE HEALTH OF WOMEN. ADVANCING SCIENCE FOR THE HEALTH OF WOMEN IS A FRAMEWORK THAT INTEGRATES THE CONGRESSIONALLY MANDATED ORWH MISSION WITH THE MISSION AREAS OF THE NIH INSTITUTES AND CENTERS TO ADVANCE A VISION WHERE SEX AND GENDER INFLUENCES ARE INTEGRATED INTO THE BIOMEDICAL RESEARCH ENTERPRISE. EVERY WOMAN RECEIVES EVIDENCE-BASED DISEASE PREVENTION AND TREATMENT TAILORED TO HER OWN NEEDS, CIRCUMSTANCES AND GOALS, AND WOMEN IN SCIENCE CAREERS REACH THEIR FULL POTENTIAL. TO ACHIEVE THIS VISION, WE MUST RECOGNIZE THAT WOMEN'S HEALTH RESEARCH IS RESEARCH THAT IS RELEVANT TO THE HEALTH OF WOMEN. THE TERM WOMEN'S HEALTH AS YOU KNOW WAS ONCE TAKEN TO BE SYNONYMOUS WITH REPRODUCTIVE HEALTH. HOWEVER, TODAY, THINKING ABOUT THE HEALTH OF WOMEN ENCOMPASSES THINKING ABOUT ALL DISEASES AND CONDITIONS THAT AFFECT WOMEN. AND RECOGNIZES THAT INDIVIDUAL LEVEL BIOLOGICAL FACTORS INFLUENCE HEALTH AND INTERACT WITH NUMEROUS OTHER FACTORS ACROSS A WOMAN'S LIFE COURSE. THIS PLAN PROMOTES A SHIFT FROM RESEARCH ON WOMEN'S HEALTH TO RESEARCH RELEVANT TO THE HEALTH OF WOMEN, AND OUTLINES AN APPROACH THAT CONSIDERS THE INTERSECTIONS OF THE MANY FACTORS THAT AFFECT HEALTH. YOU HEARD DR. BEVANS MENTION SOME CROSS CUTTING THEMES THAT WERE ARTICULATED BY OUR STAKEHOLDERS. THESE THEMES HAVE BECOME THE GUIDING PRINCIPLES FOR THE NEW PLAN. SCIENCE THAT WILL IMPROVE THE HEALTH OF WOMEN IS GUIDED BY PRINCIPLES THAT INTEGRATE MULTIPLE POPULATIONS, PERSPECTIVES, AND FACTORS, FIRST AND FOREMOST, SEX AND GENDER. THESE PRINCIPLES ARE FOUNDATION MALL TO ADVANCING SCIENCE FOR THE HEALTH OF WOMEN. THE FIRST PRINCIPLE I WANT TO DISCUSS ADDRESSES POPULATIONS. THE INTENT OF THIS PRINCIPLE IS TO RAISE AWARENESS THAT RESEARCH MUST BE RELEVANT TO ALL WOMEN, DRAWING SPECIFIC ATTENTION TO POPULATIONS OF WOMEN KNOWN TO EXPERIENCE A DISPROPORTIONATE BURDEN OF ILLNESS. OFTEN THESE POPULATIONS ARE AT THE INTERSECTION BETWEEN RACE ETHNICITY, SEX, GENDER AND AGE. FOR EXAMPLE, SOME WOMEN IN HEALTH DISPARITIES POPULATIONS EXPERIENCE DISPROPORTIONATE BURDENS FOR SOME DISEASES. WOMEN WOULD ARE WHO ARE PREGNANT OR LACTATING AS WELL AS THOSE WITH PHYSICAL OR DEVELOPMENTAL DISABILITIES ARE ALSO UNDERSTUDIED. UNDERSTANDING THE BURDEN OF ILLNESS AT EVERY AGE AND EVERY STAGE REQUIRES INTENTIONAL EFFORTS TO INCLUDE THESE WOMEN. THE SECOND PRINCIPLE IS THAT OF MULTIPLE PERSPECTIVES, HIGHLIGHTING INTERDISCIPLINARY RESEARCH, A LONG-STANDING VALUE FOR ORWH. SCIENTISTS AND EXPERTS ACROSS MANY SECTORS MUST WORK TOGETHER TO ENSURE RIGOROUS SCIENCE AND INVESTIGATE THE COMPLEX INTERSECTION OF MULTIPLE FACTORS UNDERLYING THE DISEASES AND CONDITIONS THAT AFFECT WOMEN. INTERDISCIPLINARY RESEARCH PROVIDES A BROAD RANGE OF EXPERTISE THAT CAN CONTRIBUTE SYNERGISTICALLY TO THE DESIGN AND CONDUCT OF RESEARCH RELEVANT TO THE HEALTH OF WOMEN. THE THIRD PRINCIPLE IS THE CONSIDERATION OF THE INTERSECTION AMONG MULTIPLE BIOLOGICAL FACTORS AND THE CONTEXT OF A WOMAN 18 LIFE. WOMAN'S LIFE REPRESENTED BY THIS MULTIDIMENSIONAL FRAMEWORK. THE HEALTH OF WOMEN IS AFFECTED BY THE COMPLEX INTERSECTION OF MULTIPLE FACTORS AT THE LEVEL OF THE INDIVIDUAL WOMAN, HER FAMILY, COMMUNITY, AND SOCIETY. BIOLOGICAL INTERNAL FACTORS HERE AT THE BOTTOM OF THE GRAPHIC INTERACT WITH THE SOCIAL AND CONTEXTUAL OR EXTERNAL ASPECTS ACROSS A WOMAN'S LIFE COURSE TO AFFECT HEALTH STATUS, DISEASE PRESENTATION, AND TREATMENT RESPONSE, AS WELL AS THE EFFECTS OF DISEASES AND CONDITIONS ON QUALITY OF LIFE. THIS FRAMEWORK IS NOT TO SUGGEST THAT ALL FACTORS FEED TO BE INCLUDED IN EVERY ANALYSIS FOR THERE TO BE RELEVANCE TO THE HEALTH OF WOMEN. INSTEAD IT IS TO SUGGEST THAT NO SINGLE DIMENSION IS SUFFICIENT TO UNDERSTAND THE HEALTH OF WOMEN. THE INTENT OF THIS FRAMEWORK IS TO ACKNOWLEDGE THAT MULTIPLE FACTORS, FOREMOST SEX AND GENDER, MUST BE CONSIDERED IN RESEARCH AND THAT DOING SO WILL ADVANCE SCIENCE FOR THE HEALTH OF WOMEN. TO SUMMARIZE THE PRINCIPLES, THE INTENTIONAL CONSIDERATION OF A MULTIDIMENSIONAL FRAMEWORK, INCLUSION OF DIVERSE STUDY POPULATIONS, AND ACTIVE ENGAGEMENT OF A WIDE RANGE OF SCIENTISTS WITH DIFFERING SKILLS AND EXPERIENCES IS CRITICAL TO ACHIEVING THE STRATEGIC OBJECTIVES THAT GUIDE NIH RESEARCH ON THE HEALTH OF WOMEN. THE ULTIMATE AIM OF ADVANCING SCIENCE FOR THE HEALTH OF WOMEN REQUIRES THE PURSUIT OF SEVERAL SPECIFIC GOALS. THIS STRATEGIC PLAN EMPHASIZES AN INTERCONNECTED APPROACH TO LEAD TO THE ULTIMATE GOAL, TO ADVANCE RELEVANT AND RIGOROUS RESEARCH FOR WOMEN, TO LEVERAGE DATA SOURCES, TO ENHANCE DISSEMINATION AND IMPLEMENTATION, TO IMPROVE EVALUATION, AND ALWAYS TO PROMOTE TRAINING AND CAREERS. FIRST AND FOREMOST, THE NEW PLAN AIMS TO ADVANCE RIGOROUS RESEARCH THAT IS RELEVANT TO THE HEALTH OF WOMEN. THIS GOAL ENCOURAGES RESEARCH THAT WILL FOSTER INNOVATION, EXPAND EMERGING AREAS OF RESEARCH, AND ADDRESS ISSUES OF PUBLIC HEALTH IMPORTANCE. RESEARCH IS NECESSARY TO IMPROVE THE FUNDAMENTAL UNDERSTANDING OF HOW SEX AND GENDER INFLUENCE HEALTH AND DISEASE AND EXTEND THIS KNOWLEDGE TO TRANSLATIONAL AND CLINICAL STUDIES. THE FIRST OBJECTIVE HIGHLIGHTS THE NEED FOR RESEARCH THAT EXAMINES THE POSSIBLE INFLUENCE OF SEX ON NORMAL BIOLOGY AND ABNORMAL PATHOPHYSIOLOGY IN BASIC AND PRE-CLINICAL RESEARCH. THE SECOND SUPPORTS RESEARCH ON THE DIFFERENTIAL IMPACT OF SEX AND GENDER ON DISEASE PREVENTION, DIAGNOSIS, INTERVENTION AND RECOVERY. THE THIRD OBJECTIVE EMPHASIZES THE IMPORTANCE OF RESEARCH TO EXPLORE THE EFFECTS OF EXPOSURES ON HEALTH AND DISEASE WITH A FOCUS ON THE LIFE COURSE. THE FOURTH FOCUSES ON THE COULD OH NEXT BETWEEN THE MIND AND BODY AND ITS IMPACT ON HEALTH AND DISEASE IN WOMEN AND MEN, AND THE FIFTH OBJECTIVE BRINGS ATTENTION TO OUR NEED FOR RESEARCH ON FEMALE-SPECIFIC DISEASES WITH A FOCUS ON MATERNAL AND GYNECOLOGIC HEALTH. RESEARCH THAT IS RIGOROUSLY DESIGNED CONSIDERS THE INFLUENCE OF SEX AND GENDER, WILL CONTRIBUTE TO THE NIH AGENDA FOR WOMEN'S HEALTH RESEARCH AND ADVANCE THE HEALTH OF WOMEN. ADVANCING SCIENCE FOR THE HEALTH OF WOMEN REQUIRES METHODS THAT CONSIDER THE INFLUENCES OF SEX AND GENDER, LEVERAGE RELEVANT DATA SOURCES, AND INCLUDE UNDERREPRESENTED WOMEN. THE FIRST TWO OBJECTIVES HERE HIGHLIGHT RESEARCH TO IMPROVE THE HEALTH OF WOMEN DEPENDS ON CREATIVE APPROACHES TO STUDY DESIGNS, APPLICATIONS OF MEASURES, DATA COLLECTION AND ANALYSES TO DETECT THE INFLUENCE OF SEX AND GENDER. THE THIRD FOCUSES ON RESEARCH THAT LEVERAGES AVAILABLE DATA SOURCES TO EXPAND AND ACCELERATE ADVANCES TO IMPROVE THE HEALTH OF WOMEN. AND THE FOURTH OBJECTIVE ADDRESSES THE NEED TO EXPAND METHODOLOGIES TO RECRUIT AND RETAIN WOMEN THAT ARE NOT WELL REPRESENTED IN CLINICAL RESEARCH, AND FOR WHOM DATA ON OUTCOMES ARE LACKING. ADVANCING SCIENCE FOR THE HEALTH OF WOMEN DEPENDS ON RIGOROUS AND EFFICIENT DISSEMINATION AND IMPLEMENTATION OF EVIDENCE TO IMPROVE WOMEN'S HEALTH. IMPLEMENTATION SCIENCE HAS AN IMPORTANT ROLE IN TRANSLATING RESEARCH INTO EFFECTIVE PRACTICES, INTERVENTIONS AND POLICIES ALLOWING WOMEN AS WELL AS MEN TO RECEIVE INDIVIDUALIZED SEX JEAND SEX AND GENDER APPROPRIATE BASED HEALTHCARE. PARTNERSHIPS WITH RESEARCHERS, PROVIDERS, ADVOCACY AND THE COMMUNITY ARE ESSENTIAL TO EFFECTIVELY COMMUNE KATE COMMUNICATE EVIDENCE-BASED HEALTH INFORMATION AND TO UNDERSTAND EXISTING REAL WORLD CHALLENGES. ADVANCING SCIENCE FOR THE HEALTH OF WOMEN REQUIRES A WELL TRAINED DIVERSE AND ROBUST WORKFORCE TO DRIVE THE ENGINE FOR SCIENTIFIC PROGRESS. THE FIRST TWO OBJECTIVES HERE FOCUS ON TRAINING THE WORKFORCE, WOMEN AND MEN, AND INTERDISCIPLINARY RESEARCH CAREERS IN WOMEN'S HEALTH AND MORE BROADLY TRAINING SCIENTISTS, CLINICIANS AND OTHER HEALTH PROFESSIONALS ON HOW BEING A WOMAN OR A MAN INFLUENCES HEALTH AND DISEASE. HERE THE AIM IS TO ACCELERATE THE TRANSLATION OF KNOWLEDGE INTO PRACTICE. THE NEXT THREE OBJECTIVES HIGHLIGHT THE NEED FOR EFFORTS TO SUPPORT WOMEN AT ALL STAGES OF THEIR RESEARCH CAREERS. MORE SPECIFICALLY, THE NEED TO ENHANCE AND DEVELOP PROGRAMS TO SUPPORT, RETAIN AND ADVANCE WOMEN TO PROMOTE AND SUPPORT POLICIES, MENTORING AND NETWORKS, COLLABORATIONS AND INFRASTRUCTURE TO RETAIN AND ADVANCE WOMEN, AND LASTLY, TO PROMOTE AND DISSEMINATE RESEARCH ON BARRIERS FOR WOMEN BIOMEDICAL CAREERS AND IMPORTANTLY INTERVENTIONS TO IMPROVE THEIR RETENTION AND ADVANCEMENT. ADVANCING SCIENCE FOR THE HEALTH OF WOMEN DEPENDS ON IMPROVING EVALUATION OF OUR RESEARCH INVESTMENTS. RESEARCH THAT IS RELEVANT TO THE HEALTH OF WOMEN. RESEARCH OF RELEVANCE SPANS ALL MISSION AREAS OF THE NIH INSTITUTES AND CENTERS AND THE FIRST TWO OBJECTIVES HIGHLIGHT THE NEED TO OPTIMIZE THE IDENTIFICATION OF THIS RESEARCH AND THE NEED TO ENHANCE SYSTEMATIC TRACKING AND ANALYSIS OF OUR EFFORTS TO ADVANCE SCIENCE FOR THE HEALTH OF WOMEN. THE LAST OBJECTIVE AIMS TO IDENTIFY PRIORITY AREAS FOR RESEARCH AND ALIGN THESE INVESTMENTS WITH IMPORTANT PUBLIC HEALTH NEED AND SCIENTIFIC ADVANCES TO ACCELERATE PROGRESS FOR THE HEALTH OF WOMEN. THIS STRATEGIC PLAN FOR WOMEN'S HEALTH RESEARCH WILL OPERATE IN SYNERGY WITH THE NIH-WIDE STRATEGIC PLAN. THESE ARE THE PRIMARY MAPPINGS, HOWEVER, THERE ARE MULTIPLE AREAS OF ALIGNMENT. BY OPERATING IN SYNERGY WITH THE NIH-WIDE STRATEGIC PLAN, THE 2019 TO 2023 TRANS-NIH STRATEGIC PLAN FOR WOMEN'S HEALTH RESEARCH WILL ADVANCE THE NIH'S OVERALL MISSION, TO TURN DISCOVERY INTO HEALTH FOR EVERYBODY. TO ADVANCE SCIENCE FOR THE HEALTH OF WOMEN, THE NIH NEEDS YOU. WE NEED TO YOU CONNECT WITH YOUR NETWORKS IN RESEARCH, IN SCIENCE, IN MEDICINE AND BEYOND. WE NEED YOU TO SERVE AS AMBASSADORS FOR THIS MULTIDIMENSIONAL FRAMEWORK FOR THE INCLUSION OF ALL WOMEN AND FOR INTERDISCIPLINARY RESEARCH. WE NEED YOU TO ADVOCATE FOR THE PLAN AND SEX AS A BUY BIOLOGICAL VARIABLE IN YOUR SPHERES OF INFLUENCE, FOR EXAMPLE, ON EDITORIAL BOARD, AS EDITORS AND IN OTHER SPHERES. WE NEED YOU TO HELP US GET THE WORD OUT ABOUT THIS NEW PLAN, AND IMPORTANTLY, WE NEED YOU TO ADVISE US ON ITS IMPACT IN THE REAL WORLD. SO I'M EXCITED TO SHARE WITH YOU TODAY A RESOURCE FOR YOU THAT HIGHLIGHTS THE GUIDING PRINCIPLES OF THE PLAN AND THE GOALS AND OBJECTIVES OF THE PLAN AS WE MOVE FORWARD TO SECURE FULL AND FINAL APPROVAL FOR THE FINAL PLAN IN THE VERY NEAR FUTURE. THANK YOU VERY MUCH FOR YOUR ATTENTION. [APPLAUSE] NEXT I AM GOING TO INTRODUCE DR. SAMIA NOU RSI, ASSOCIATE DIRECTOR FOR SCIENCE POLICY PLANNING AND ANALYSIS, AND SHE'LL TALK ABOUT EARLY STAGES OF THINKING ABOUT HOW TO IMPLEMENT AND EVALUATE THIS PLAN. YOU KNOW, YOU'RE SUPPOSED TO THINK ABOUT EVALUATING WHEN YOU DESIGN YOUR PLANS, AND WE HAVE A REALLY INTERESTING APPROACH THAT I THINK THAT YOU WILL LIKE. WE'RE LOOKING FORWARD TO HEARING FROM YOU. DR. NOURSI. >> THANK YOU. THANK YOU, DR. CLAYTON. SO AS DR. CLAYTON MENTIONED, WE ARE EARLY IN THE PROCESS OF THINKING AND PLANNING ABOUT NEXT STEPS. AS WE MOVE FORWARD WITH RECEIVING APPROVAL FROM DR. COLLINS ON OUR STRATEGIC PLAN, WE ARE THINKING ABOUT THE NEXT THREE STEPS FORWARD, DISSEMINATION OF THE PLAN, IMPLEMENTATION OF THE PLAN, AND ITS EVALUATION. SO THE DISSEMINATION OF THE PLAN WILL START AS SOON AS WE RECEIVE APPROVAL. WE RELY ON ALL THE I.C.s AND THE I.C. REPRESENTATIVES, WE RELY ON YOU, WE RELY ON OUR STAKEHOLDERS TO DISSEMINATE THE PLAN. WE ALSO HAVE OUR COMMUNICATION TEAM, MANY OF THEM ARE HERE. THEY HAVE A PLAN TO DISSEMINATE THE PLAN. [LAUGHTER] SO AS WE DISSEMINATE THE PLAN, WE WOULD LIKE TO WORK WITH ALL THE I.C.s AND THE I.C. REPRESENTATIVES WHO ARE HERE AND THOSE WHO ATTEND OUR CCWH MEETINGS AS WELL AS ALL THE I.C. OR MEMBERS THAT WE WORK WITH TO IMPLEMENT THE STRATEGIC PLAN IN THEIR I.C.s. THE SUCCESS OF THE PLAN RELIES ON IMPLEMENTING IT IN ALL THE I.C.s. THE ULTIMATE GOAL OF THE IMPLEMENTATION IS TO BE ABLE TO, DOWN THE ROAD, LOOK AT THE IMPLEMENTATION AND SAY, OKAY, WHAT REACTIONS DO WE HAVE IN THE I.C.s WITH REGARD TO THIS PLAN? IS WE ACKNOWLEDGE EACH I.C. HAS DIFFERENT STRUCTURE AND DIFFERENT PLAYERS BUT WE'RE HOPING THAT THE I.C.s WILL IDENTIFY THE FOLKS IN THOSE I.C.s THAT HAVE THE SKILLS AND THE CAPACITY TO BE ABLE TO WORK WITH US TO IMPLEMENT THE PLAN. WE WILL HAVE A TIMELINE AND WE WILL WORK WITH ALL THE I.C.s ON THIS TIMELINE AND SHARE WITH THEM THE TIMELINE THAT WE HAVE. NEXT WILL BE THE EVALUATION. THE EVALUATION GOAL FIRST AND FOREMOST IS TO CREATE A CHAIN OF EVIDENCE THAT CHECK WILL SHOW THE PROGRESS THAT WAS MADE BY THE IMPLEMENTATION OF THE PLAN ALONG THE WAY. WE WILL BE SYSTEMATIC IN OUR EVALUATION, WE WILL BE COMPREHENSIVE AND WE WILL BE COLLABORATIVE. AGAIN, WE WILL NEED THE HELP OF THE I.C.s IN THIS PLAN. WE RELIED ON YOU IN DEVELOPMENT OF THE PLAN AND WE CONTINUE TO RELY ON YOU IN THE IMPLEMENTATION AS WELL AS THE EVALUATION. WE ENVISION A HYBRID OF QUALITATIVE AND QUANTITATIVE METHODS TO COLLECT THE DATA. WE WILL INCLUDE SHORT AND LONG TERM OUTCOMES IN OUR EVALUATION, AND WE HOPE THAT THE END -- THAT WE WILL PROVIDE WITH MEANINGFUL EVIDENCE THAT WE WILL THE STRATEGIC PLAN AND GOALS AND OBJECTIVES CONTRIBUTE TO THE MISSION OF ORWH AS WELL AS THE ENTIRE NIH. WITH THAT, I WOULD LIKE TO INVITE DR. CLAYTON FOR A MOTION ON ESTABLISHMENT OF THE WORKING GROUP ON THE IMPLEMENTATION AND EVALUATION PLAN. >> WE HAVE PERMISSION TO ESTABLISH A NEW WORKING GROUP ON IMPLEMENTATION AND EVALUATION OF THIS NEW SOON TO BE UNVEILED FULLY STRATEGIC PLAN. DO I HAVE A MOTION FROM ONE OF THE MEMBERS? SO DR. PREG GREGORY MOVED AND A SECOND BY DR. BEAR EE MERRS. ALL IN FAVOR INDICATE BY SAYING AYE. ANY OPPOSED PLEASE INDICATE BY SAYING NO. THE MOTION CARRIES. SO WE HAVE FORMED A NEW WORKING GROUP AND WE WILL LOOK FORWARD TO WORKING WITH ALL OF YOU ON ACRWH INTERESTED IN THAT NEW WORKING GROUP. SO IT'S BEEN MOVED AND SECONDED, AND I THINK THAT I WANT TO THANK DR. NOURSI FOR PRESENTING THE EARLIEST PHASES OF THIS IMPLEMENTATION AND EVALUATION EFFORTS AND WE WILL BE CONTINUALLY SEEKING YOUR INPUT ALONG THE WAY. THANK YOU. >> THANK YOU VERY MUCH. [APPLAUSE] >> I'D LIKE TO INVITE TO THE PODIUM DR. REBECCA DELLCARMEN-WIGGINS. WE'RE GOING TO HAVE TIME FOR DISCUSSION BUT I WANT TO GET THROUGH THIS LAST PORTION OF THE AGENDA BEFORE WE OPEN IT UP TO ADVISORY COMMITTEE MEMBERS TO HAVE DISCUSSION. BUT I WANT TO INVITE DR. REBECCA, A RESEARCH PROGRAM OFFICER AT ORWH, TO TALK TO YOU ABOUT SOME VERY EXCITING NEW OPPORTUNITIES. >> THANK YOU, DR. CLAYTON. GOOD AFTERNOON, EVERYONE. I AM REALLY PLEASED TO BE HERE TO TALK WITH YOU TODAY ABOUT OPPORTUNITIES FOR ADVANCING SEX AND GENDER IN HEALTH AND DISEASE. AND TO PRESENT A CONCEPT FOR A NEW ORWH FUNDING OPPORTUNITY ANNOUNCEMENT. THE OBJECTIVE OF THIS INITIATIVE IS TO SUPPORT AND ENCOURAGE INVESTIGATOR INITIATED INTEGRATIVE INTERDISCIPLINARY RESEARCH ON SEX AND GENDER INFLUENCES ON HEALTH AND DISEASE, AND TO IMPROVE AND INFORM THE HEALTH OF. THE RATIONAL FOR THIS CONCEPT IS BASED ON LANDMARK DEVELOPMENTS THAT HAVE TAKEN PLACE IN THIS SPACE OVER THE LAST FEW YEARS. IN 2015, ORWH IN COLLABORATION WITH THE NATIONAL ACADEMIES OF SCIENCES CONFLICT OF INTEREST VEENED A WORKSHOP ENTITLED THE -- MANY ANALYSES OF HEALTH DATA HAVE NOT BEEN DISAGGREGATED BY SEX, AND, THEREFORE, MAKING IT DIFFICULT TO USE THAT DATA TO IMPROVE THE HEALTH OF WOMEN AND TO PROVIDE EVIDENCE-BASED CARE TO WOMEN. WHAT WERE THE RECOMMENDATIONS AT THE WORKSHOP? INTERDISCIPLINARY APPROACHES, ROUTINE SEX DISAGGREGATION OF DATA, REFINED MEASUREMENT TOOLS, AND INTEGRATIVE APPROACHES WERE ALL DEEMED CRITICAL TO ADDRESSING THE HEALTH CHALLENGES OF WOMEN TODAY. IN JANUARY OF 2016, NIH ADOPTED A NEW POLICY ENHANCING REPRODUCIBILITY THROUGH RIGOR AND TRANSPARENCY WHICH MANDATED THAT INVESTIGATORS CONSIDER SEX AS A BIOLOGICAL VARIABLE IN THE RESEARCH THAT THEY CONDUCT. AS PART OF THIS RECOMMENDATION, THE OFFICE OF RESEARCH ON WOMEN'S HEALTH IN COLLABORATION WITH THE 27 I.C.s TOGETHER FUNDED A RIGOROUS RESEARCH AIMED AT IMPROVING THE HEALTH OF WOMEN AND MEN ACROSS MANY AREAS OF SCIENCE. THE TRANS-NIH STRATEGIC PLAN FOR WOMEN'S HEALTH RESEARCH WILL REPRESENT NIH'S CONTINUED COMMITMENT TO FILL THE GAPS IN KNOWLEDGE ABOUT THE HEALTH OF WOMEN ACROSS A WIDE RANGE OF DISEASES AND CONDITIONS SPANNING THE MISSIONARIES OF THE NIH I.C.s. FRAMEWORK AND TIMELY OPPORTUNITY FOR THIS NEW FOA TO ADVANCE AN ORWH LED CONCEPT THAT WILL FOCUS ON PRIORITIZING AND STIMULATING RESEARCH ON THE INFLUENCE OF SEX AND GENDER AND THEIR INTERACTION IN HEALTH AND DISEASE. FURTHER, THIS WOULD BE CONSISTENT WITH THE NEED TO KEEP PACE WITH RAPID CHANGES IN SCIENCE AND TECHNOLOGY AND EVOLVING PUBLIC HEALTH NEEDS AND PUBLIC HEALTH MANDATES SUCH AS THE 21ST CENTURY CURES ACT. THIS THIS ACT EXTENDS OUR COMMITMENT EXPANDS REPORTING REQUIREMENTS FOR CLINICAL TRIAL, EMPHASIZES THE SABV POLICY AND INCORPORATES CHANGES TO ENCOURAGE RESEARCH COLLABORATION AMONG THE NIH INSTITUTES AND CENTERS WITH THE GOAL OF IMPROVING THE HEALTH OF ALL PEOPLE. BASED ON THESE LANDMARK DEVELOPMENTS, THIS CONCEPT FOR RESEARCH FUNDING ON THE APPLICATION OF CONSIDERATION ABOVE SEX AND GENDER AND THEIR INTERACTION OF HEALTH AND DISEASE WOULD INCENTIVIZE INTERDISCIPLINARY APPROACHES, ACCELERATE CONCEPT UPTAKE AND OPEN AVENUES TO NEW DISCOVERIES. DESPITE NOT HAVING DIRECT GRANT-MAKING AUTHORITY OVER THE YEARS, ORWH HAS WORKED DILIGENTLY AND COLLABORATIVELY WITH OUR I.C. PARTNERS TO ADVANCE SEX DIFFERENCES RESEARCH TO INFORM THE FIELD. THE SCORE PROGRAM IS OVER -- I'M SORRY -- IT'S OVER 10 YEARS OLD AND, AS YOU HEARD EARLIER, HAS BEEN EXPANDED TO A COOPERATIVE AGREEMENT WITH A CAREER ENHANCEMENT CORE. THE BIRCWH PROGRAM NOW INCORPORATES THE SABV, IN FACT, OUR UPCOMING MEETING HAS A SESSION ON HOW THESE PROGRAMS WILL BE PROVIDING TRAINING ON SABV. ORWH PROVIDES R56 AWARDS AND THESE AND OTHER CO-FUNDING FOR SA SAVB RELATED WORK WITH A FOCUS ON SEX AND GENDER AND HOW THAT CAN IMPROVE WOMEN'S RESEARCH. IT WENT INTO EFFECT FOR ALL VERT GREAT BRAIT ANIMAL AND HUMAN STUDIES EFFECTIVE JANUARY 2016 AND NOW IS RELEVANT AFFECTING ALL FOAs, ALL I.C.s, ALL AREAS OF STUDY AND PEER REVIEW BROADLY HAS BECOME ORIENTED TO THESE ISSUES. AT A TIME OF INCREASING APPRECIATION FOR THE IMPORTANCE OF SEX AS A BIOLOGICAL VARIABLE ACROSS THE I.C.s AND VARIOUS SCIENTIFIC DISCIPLINES, THIS NEW FOA CAN BUILD ON THE INCREASING DATA FROM OUR PRIOR INVESTMENTS AND ALSO TO COMPLEMENT THE OTHER SUCCESSFUL ONGOING ORWH INITIATIVES SUCH AS THE SEX AND GENDER SUPPLEMENTS PROGRAM AND THE U3 PROGRAM RESEARCH SUPPLEMENT PROGRAM ON THE HEALTH OF UNDERSTUDIED, UNDERREPRESENTED AND UNDERREPORTED POPULATIONS. SO, THE TIME MAY BE RIGHT FOR AN INVESTIGATOR INITIATED SEX AND GENDERS INFLUENCE FOA THAT WOULD ALLOW BROAD SCIENTIFIC AREAS TO BE STUDIED AND TO BE RESPONSIVE TO THE AMAZING SCIENTISTS OUT THE THERE AND THEIR RICH AND GENERATIVE IDEAS IN HEALTH. THIS WOULD NOT BE THE FIRST TIME ORWH HAS FOCUSED ON AN INVESTIGATOR-INITIATED FUNDING OPPORTUNITY. IN 2010, ORWH RELEASED AN R21 FOA ADVANCING NOVEL SCIENCE IN WOMEN'S HEALTH RESEARCH, ANSWHR. IT WAS VERY WELL RECEIVED BY OUR INCLUDE A NIAID PROJECT TO EXAMINE MECHANISMS UNDERLYING SEX DIFFERENCES IN THE PATHOGENESIS OF INFLAMMATORY BOWEL DISEASE AND NICHD PROJECT ON TAILORED OUTCOMES FOR FEMALE URINARY INCONTINENCE, AND NHLBI PROJECT ON CARDIOVASCULAR DISEASE MARKERS, AND MEDIATION OF HORMONE THERAPY EFFECTS, AND AN NIMH PROJECT ON SEX-SPECIFIC NEUROANATOMICAL MARKERS OF VULNERABILITY IN AN ANIMAL MODEL OF PTSD. SOME OF THESE R21 AWARDS WERE TO EARLY INVESTIGATORS WHO WENT ON TO RECEIVE R01s IN THEIR FIELD. FOR EXAMPLE, ONE NIGMS ANSWHR AWARD TO LOOK AT MACROPHAGE PHENOTYPES TO LOOK AT ORGAN PROLAPSE REPAIR FORM THE BASIS FOR A SUCCESSFUL R01 ON ASSESSING THE IMPACT OF MACROPHAGE POLARIZATION UPON THE SUCCESS OF BIOMATERIAL IMPLANTS BY DR. BROWN. SO THESE AWARDS CAN BE USED NOT ONLY TO ADVANCE THE SCIENCE BUT TO ADVANCE SCIENTISTS IN SEX AND GENDER RELATED WORK ACROSS AND BETWEEN DISCIPLINES. >> WHICH WE WOULD LIKE TO BE THE FOCUS OF THIS NEW CONCEPT. AT THE TOP ARE GENDER RELATED VARIABLES INCLUDING FOR EXAMPLE SOCIETALLY BASED DIFFERENCES IN NUTRITION AND LIFESTYLE, SEX IS REPRESENTED AT THE BOTTOM INCLUDING BIOLOGICALLY BASED SEX HORMONES. WE NEED INVESTIGATIVE AND INTEGRATIVE RESEARCH THAT LOOKS AT SEX AND GENDER AS THEY INTERSECT ACROSS A VARIETY OF DISEASE INDICES. ONE EXAMPLE IN A RECENT NINDS STUDY REPORTED IN NATURE SHOWS THAT SCIENTISTS WERE ABLE TO STUNT THE PUBERTY OF MALE WORMS BY STARVING THEM BEFORE THEY UNDERWENT SEXUAL MATURATION, DEMONSTRATING THAT ENVIRONMENTAL STRESS IN WORMS CAN PERMANENTLY AND PROFOUNDLY IMPACT THE CONNECTIVITY OF A DEVELOPING NERVOUS SYSTEM. OUT OF A LAB AT COLUMBIA UNIVERSITY IT WAS DEMONSTRATED THAT EXPOSURE TO STARVATION STRESS BEFORE MATURATION HAD A SEX-SPECIFIC EFFECT BY INTERRUPTING THE REWIRING PROGRAM IN MALES LEAVING THE ADULT MALE WORMS WITH IMMATURE CIRCUITS. SO THERE IS A NEED FOR INTEGRATIVE RESEARCH THAT INVESTIGATES HOW SEX INTERACTS WITH GENDER IN THE CONTEXT OF DISEASE-SPECIFIC HYPOTHESES. EXAMPLES OF BROAD AREA FOR SEX AND GENDER INTEGRATION INCLUDE DISCOVERY OF BASIC BIOLOGICAL DIFFERENCES STRUCTURAL AND FUNCTIONAL BETWEEN MALES AND FEMALES, INVESTIGATIONS OF THE INFLUENCE OF SEX AND GENDER AND THEIR INTERACTION ON DISEASE PREVENTION, PRESENTATION, MANAGEMENT AND OUTCOMES, IDENTIFICATION OF THE IMMEDIATE MID AND LONG-TERM EFFECTS OF EXPOSURES ON HEALTH AND DISEASE OUTCOMES, PROMOTION OF RESEARCH THAT CAN EXPLORE THE INFLUENCE OF SEX AND GENDER ON THE CONNECTION BETWEEN THE MIND AND BODY AND ITS IMPACT ON HEALTH AND DISEASE. AND EXPANSION OF RESEARCH ON FEMALES SPECIFIC CONDITIONS AN DISEASES INCLUDING REPRODUCTIVE STAGES AND MATERNAL AND GYNECOLOGICAL HEALTH. SO TO SUMMARIZE, THIS IS A PROPOSAL FOR A NEW ORWH FUNDING OPPORTUNITY ANNOUNCEMENT TO FUND INVESTIGATOR INITIATED INTERDISCIPLINARY RESEARCH THAT FOCUS -- CAN FOCUS EXCLUSIVELY ON THE APPLICATION OF INTEGRATED SEX AND GENDER CONSIDERATIONS IN HEALTH RESEARCH. SO THANK YOU VERY MUCH. [APPLAUSE] >> THANK YOU, DR. DEL CARMEN WIGGINS. PLEASE JOIN US AT THE TABLE FOR DISCUSSION. YOU HEARD AN AMAZING BEGINNING OF THE AFTERNOON WITH INCREDIBLE HISTORICAL PERSPECTIVE AND I FOR ONE AM GRATEFUL FOR THE ENERGY THAT THESE TRAIL BLAZING WOMEN HAVE CREATED AND THEIR LEGACY. AS WE SEEK TO MOVE FORWARD, IT IS VERY IMPORTANT FOR US TO HEAR FROM YOU, YOUR IDEAS ABOUT ANY ASPECTS WE DISCUSSED EARLIER TODAY, THE STRATEGIC PLAN THAT WILL BE FORTHCOMING SO THE OBJECTIVES AND GOALS AND GUIDING PRINCIPLES SHARED BUT HOW WE MIGHT GO TO THE NEXT LEVEL OF PLEA AGREEMENT TAG AS WELL AS THIS CON -- IMPLEMENTATION AS WELL AS THIS CONCEPT JUST PRESENTED TO YOU. SO I'LL OPEN THE FLOOR FOR DISCUSSION. DR. REAGAN STEINER. >> QUICK QUESTION GIVEN -- CAN YOU GIVE ME AN EXAMPLE FOR WHAT THAT COULD LOOK LIKE, LIKE -- BECAUSE WE ALREADY CAN STUDY SEX DIFFERENCES IN A GRANT IF WE WANT TO, HOW WOULD THIS WORK? WHAT KIND OF GRANT WOULD WE FUND? >> ONE EXAMPLE IS IN THE AREA OF DEPRESSION AND WE KNOW FOR EXAMPLE THAT THE RATE OF DEPRESSION DOUBLES AT -- IN ADOLESCENTS, THE RATE IS DOUBLED OUT OF MEN BEGINNING IN PUBERTY. WE HAVE KNOWN THAT FOR DECADES BUT WE DO NOT KNOW WHY SO IT'S GOING TO TAKE THIS KIND OF RESEARCH THAT INTEGRATE LOOKING AT IS IT HORMONAL, HOW DO HORMONES INTERACT WITH PRESSURES AND STRESSES THAT HAPPEN DURING ADOLESCENCE FOR YOUNG WOMEN TO RESULT IN THOSE RATES. DO YOU HAVE SOMETHING TO ADD TO THAT? >> SO AS YOU KNOW, THE SCORE IS THE ONLY NIH CENTER LEVEL DISEASE AGNOSTIC SEX DIFFERENCES FUNDING OPPORTUNITY THAT NIH HAS. SO YOU CAN PROPOSE INVESTIGATOR INITIATED SEX AND GENDER RESEARCH. HOWEVER, AT THIS POINT IN TIME, IT SEEMS WISE TO CONSIDER BEING CATALYTIC AND ENCOURAGING SOME SPECIFIC CONSIDERATIONS OF THE INTERACTION OF THE BIOLOGICAL ASPECTS SPECIFICALLY WITH GENDER CONTEXT. SO THAT'S THE THINKING BEHIND IT. DR. LANGER. >> JUST BUILDING ON THIS DIALOGUE AND TRYING TO BETTER UNDERSTAND, SO ONE KEY ASPECT THAT IS VERY CONSISTENT WITH THE STRATEGIC PLAN IS THIS IS DISCIPLINARY RESEARCH THAT BASED INTO CONSIDERATION GENDER MAYBE MORE THAN IN OTHER PROJECTS OR STUDIES THAT ARE MOSTLY FOCUSED ON THE BIOLOGICAL ASPECTS OF A SEX. IS THAT CORRECT? >> THE IMPORTANT OF INTERDISCIPLINARY APPROACHES IN SUCH A STUDY WITH INTERACTION BETWEEN SOCIAL BEHAVIORAL SCIENTISTS AND BASIC SCIENTISTS AND ENGINEERS, ANTHROPOLOGISTS, WHOEVER NEEDS TO BE AT TABLE. WOULD BE SOMETHING WE WOULD LIKE TO SEE COME OUT OF THAT, WE HAVE HAD A LONG STANDING COMMITMENT TO INTERDISCIPLINARY RESEARCH EVEN IN DR. PINN'S ERA, THAT'S BEEN PROMOTED. WE WANT TO TAKE IT TO THE NEXT LEVEL AND USE THIS AS A WAY TO DRIVE THAT. AND SEE IT AS MORE INTEGRATIVE AND MOVE INTERDISCIPLINARY RESEARCH TO THE NEXT LEVEL. DR. DEWEESE. >> I'M VERY ENTHUSIASTIC ABOUT THIS PLAN. I JUST SERVED ON A COMMITTEE FOR SUCH A THING THAT WAS IN EUROPE AND COLLABORATION WITH CANADA AND CALLED GENDER NET PLUS, THE OPEN CALL. YOU CAN FIND IT BY GENDER NET PLUS OPEN CALL. WE DID EXACTLY WHAT YOU ARE PROPOSING HERE. BUT I THINK IT WAS PARTICULARLY SPECTACULAR, ALL THE GRANTS CAME TOGETHER FOR A SINGLE REVIEW ON THE ENGINEERS EPIDEMIOLOGISTS, PRACTITIONERS, NURSES, BIOLOGISTS, ET CETERA, ET CETERA. AND ONLY PROPOSALS THAT REALLY INTEGRATED SEX AND GENDER GOT HIGH SCORES. I HAVE NEVER SEEN ANYTHING LIKE THAT IN THE UNITED STATES OR IN CANADA BEFORE. IT'S SOMETHING YOU SHOULD -- THAT YOU MIGHT WANT TO LOOK AT WHEN YOU START OFF. I WOULD SUGGEST. >> SO I ALSO APPLAUD REALLY GETTING GENDER INTO THE SEX DIFFERENCE ISSUE. BUT I'M A LITTLE CONCERNED ABOUT THE BINARY. I TEACH A CLASS ON CHALLENGING THE BYNARY IN BIOLOGY BECAUSE I THINK ALWAYS TALKING ABOUT MEN AND WOMEN, IS GETTING US INTO SOME TROUBLE BECAUSE BIOLOGY IS A SPECTRUM AND GENDER FROM THE WORK WE ARE DOING, WE'RE TRYING TO FIGURE HOW TO MEASURE THAT, YOU USED THE WORD INTERSECTIONALITY WHICH IS REALLY IMPORTANT WE START TO RECOGNIZE THAT GENDER VARIES THROUGH ALL THESE DIFFERENT CULTURES AND BY AGE, ACROSS THE GLOBE, SO I THINK THAT I'M FINE WITH A DOCUMENT, THIS IS GREAT WHAT WE'RE ABOUT TO DO BUT I THINK TEATIME -- IT'S TIME TO INTRODUCE SOMETHING BEYOND BYNARY AND INTERSECTIONAL. >> DR. LOPEZ. >> I THINK WE TRIED AND REALLY LINKING WITH THE FOA I THINK MY FAVORITE SLIDE IS 17. SO IF THE APPLICANTS WERE REALLY GUIDED TO THINK OF SEX AS A BIOLOGICAL VARIABLE AND TO THINK OF RESEARCH WITHIN THIS CONTEXT OF THAT DIAGRAM, WHERE IT'S ACROSS THE LIFE SPAN WHERE IT'S THE INTERACTION BETWEEN EXTERNAL AND INTERNAL BIOLOGICAL FACTORS. I THINK THAT THAT REALLY TOUCHES ON WHAT WE WERE TRYING TO THINK OF, THAT THERE ARE MULTIPLE FACTORS THAT IMPACT OVER A SPAN OF TIME. SO I THINK INCLUDING THAT DISCUSSION OF THAT SLIDE WOULD BE IMPORTANT PERSPECTIVE. >> OTHER COMMENTS? DR. MCCULLOUGH, DID YOU SEE THIS BEING SOMETHING THAT WOULD FIT IN YOUR STROKE WORK? >> THERE'S A LOT OF POTENTIAL INTERACTIONS FOR RESEARCH AT NINDS LIKE SO LOOKING AT POST DEPRESSION THINKING ABOUT HOW FUNDING SOCIAL ISOLATION IN ANIMALS SO THERE'S A LOT OF SEX BASED GENDER BASED REASONS FOR POST STROKE OUTCOMES, SAME WITH CARDIOLOGY ALSO HAS A LOT OF INTERSECTING THINGS AND THEY DO ALSO INTERSECT AGE SO IT COULD BE REALLY INTERESTING. >> DR. QUARTS. >> THIS IS SUSAN. >> HOLD ON ONE SECOND. DR. WOOD, WE CAN HEAR YOU. GO RIGHT AHEAD. >> HI, EVERYBODY, UP IN, I HAVE BEEN WATCHING AND LISTENING TO THE WHOLE MEETING AND I WISH I WERE THERE IN PERSON. I HAD SOME VERY PRACTICAL QUESTIONS ABOUT THE FOA. THAT IS THIS GOING TO BE CO-FUNDED BY ORWH AND THE INSTITUTES SIMILAR TO OTHER PROJECTS AND SPECIFICALLY IS THERE SET ASIDE FUNDS FROM BOTH ORWH AND THE REST OF NIH THAT IS GOING TO ACTUALLY BE ABLE TO FIND A SUBSTANTIAL AMOUNT OF RESEARCH ON THIS OR IS THIS JUST WE'RE GOING TO HAVE TO SEE HOW IT GOES KIND OF THING HOW THE BUDGETS GO? >> DR. WOOD, AS ALWAYS YOU GET RIGHT TO THE CRUX OF THE MATTER. THANK YOU, VERY MUCH FOR JOINING US. WE ARE AT THE VERY BEGINNING STAGES OF THIS CONCEPT, THIS IS A CONCEPT, THAT'S WHY WE'RE BRINGING IT TO YOU TO GET INPUT AND THOUGHTS WHETHER THIS IS THE RIGHT WAY TO GO FORWARD AT THIS POINT. AS YOU KNOW, WE HAVE TO WORK IN PARTNERSHIP AND WE ARE DELIGHTED TO DO SO WITH ALL OUR INSTITUTE AND CERTAINTY COLLEAGUES BECAUSE WE DO NOT HAVE -- CENTER COLLEAGUES BECAUSE WE DON'T HAVE DIRECT GRANT MAKING AUTHORITY. YOU CAN TELL FROM THE FOLKS WHO HAVE BEEN HERE TODAY, DR. KOROSHETZ HAS JOINED US, DR. BIANCI JOINED US, DR. COMPTON IS STILL HERE FROM NIDA, WE ARE ENJOYING QUITE FAVORABLE PARTNERSHIP WITH -- AND DR. ROGERS WAS HERE AND GAVE AMAZING PRESENTATION. SO WE ARE ENJOYING GREAT PARTNERSHIP WITH OUR INSTITUTES AND CENTERS AT THIS TIME AND BECAUSE OF THE NEW SABB POLICY, THEIR INVESTIGATORS ARE LOOKING AT ISSUES THEY HADN'T CONSIDERED BEFORE. WHAT THAT HAS DONE FOR EXAMPLE, IN THE OVER 300 INVESTIGATORS THAT WE HAVE SUPPLEMENTED FROM ALL THESE INSTITUTES AND CENTERS THROUGH THE SEX AND GENDER ADMINISTRATIVE SUPPLEMENTS, THEY HAVE BEEN DERIVING NEW INSIGHTS, NEW AREAS OF RESEARCH. SO THE BOTTOM LINE SUSAN IS OF COURSE WE WOULD NEED TO WORK IN PARTNERSHIP WITH THE INSTITUTES AND CENTERS AND THE DOWN SIDE IS OF COURSE OUR BUDGET HAS NOT CHANGED SO IN ORDER FOR US TO DO THINGS THAT NEED TO MOVE FORWARD WE HAVE TO MADE HARD CHOICES ABOUT OTHER THINGS THAT WE MAY NOT BE ABLE TO DO. THAT'S WHY YOU ALL ARE SO IMPORTANT IN TERMS OF ADVISING ON THOSE DECISIONS. IN TERMS OF BALANCING A RESEARCH PORTFOLIO. HOWEVER, IF WE CAN GET COMMITMENT FROM THE INSTITUTES AND CENTERS FOR A SUBSTANTIAL PROPORTION OF THIS, IT WILL BE A LOT EASIER FOR US TO MOVE FORWARD. IN ALMOST ALL INSTITUTES WOULD SUPPORT IT THEN WE WOULD BE ABLE TO MOVE FORWARD AT LEAST WITH FIRST INITIAL STEPS AT GROWING A NEW GRANT. DOES THAT ANSWER YOUR QUESTION? >> THANK YOU. YES, THAT'S REALLY HELPFUL AND I THINK IT -- IN TERMS OF MAKING DECISIONS ON THE BALANCED PORTFOLIO THOSE ARE ALWAYS -- HARD CHOICES THAT I DON'T WANT TO HAVE TO MAKE. THAT MEANS CUTTING BACK ON SOME OF THE OTHER PROJECT AREAS. ALSO I THINK THE CONCEPT OF GETTING SUPPORT FROM ACROSS NIH SO THAT THE BURDEN ISN'T DISPROPORTIONATELY ON ORWH TO FUND IT GET THE CHALLENGE TO US ON THE ADVISORY COMMITTEE AS WELL AS THE SCIENTIFIC COMMUNTY AT LARGE TO ENGAGE IN IT. >> ABSOLUTELY. OF COURSE, JUST BECAUSE WE MAY -- THINGS MAYBE CHANGING, CAROLYN HAS A COMMENT TOO. Z YOU SAID, IT'S NOT JUST ORWH FUNDING BUT FUNDING BY INSTITUTES TO TAKE UP SPECIFIC AREAS WHERE SEX AND GENDER DERIVED HYPOTHESES ARE POISED TO MOVE FORWARD NHLBI MAY PICK UP MOVE FORWARD NIDDK. IT'S REALLY -- WE HAVE TO LOOK AT THE TRANS-NIH WOMEN'S HEALTH RESEARCH PORTFOLIO WHEN YOU THINK ABOUT THIS. AND OUR ROLE IS BEING CATALYTIC AS CONVENING AND COORDINATING AND BRINGING MULTIPLE INSTITUTES TOGETHER AROUND KEY QUESTIONS AND ANSWERS THAT NEED TO BE ADDRESSED. SO I'M SRRY I LOST TRACK. DR. MISSOURI. DR. COURT, I WAS PUT HER ON THE SPOT. SINCE SHE WAS A SPEAKER I THOUGHT I COULD DO THAT. >> I FIND THIS VERY EXCITING. I HAVE ALREADY SENT OFF EMAILS TO LET PEOPLE KNOW THAT WE WILL BE APPLYING FOR OPPORTUNITIES. IT'S A GREAT COMPLIMENT TO THE SCORE PROGRAM. THE PRETTIEST FUNDING OF 750,000 DIRECT A YEAR NOW A MILLION PER YEAR SOUNDS LIKE A HUGE AMOUNT OF MONEY BUT DIVIDED ACROSS THREE PROJECTS TWO CORES THE AMOUNT PER PROJECT ESPECIALLY FOR CLINICAL PROJECT IS SMALL. SO WE USE OUR SCORE TO FUND WHAT WE THINK ARE VERY CUTTING-EDGE IDEAS, THAT WE MIGHT THINK OF ADS EXPLORATORY OR HYPOTHESIS GENERATING BUT NOW HAVING COMPLIMENTARY MECHANISM TO ENABLE YOU TO APPLY FOR THE FOLLOW ON FUNDING TO MATURE THOSE IDEAS I THINK IS ABSOLUTELY WONDERFUL. >> THANK YOU, DR. COURT. DR. MISSOURI. >> SO I WAS JUST GOING TO SAY SOMETHING THAT ACTUALLY PIVOTS OFF WENDY'S POINT AS WELL. SO THIS R-21 WOULD HAVE TRADITIONAL PARAMETERS OF TWO YEARS AND RELATIVELY SMALL AMOUNT OF FUNDING; IS THAT THE CONCEPT BEHIND IT DO YOU THINK? WE DID NOT MENTION AN ACTIVITY CODE. THAT'S ONE OPTION. PERHAPS MAYBE YOU WOULD SHARE -- >> THAT WAS THE PREVIOUS. >> RIGHT. I ASSUMED THIS WAS THE -- >> MAYBE I COULD SHARE YOUR PERSPECTIVE WHAT YOU THINK IT SHOULD BE OR COULD BE. >> I GUESS I'M OF TWO MINDS. ON THE ONE HAND IF YOU DID AN R-21 FOR TWO YEARS AND IT KIND OF MINIMAL AMOUNT OF MONEY RELATIVELY SPEAKING IT SEEMS LIKE A GREAT OPPORTUNITY TO BRING THE INSTITUTES IN BECAUSE IT ALLOWS THE INSTITUTES TO DELVE INTO IDEAS PARTICULARLY INTERESTING TO THEM IN THIS EXPLORATORY WAY WE ARE YOU CAN TAKING ABOUT. THEY ALSO GET CREDIT FOR DOING WORK IN THAT FIELD AND HAVING WORK ON SEX AND GENDER. THE OTHER PART OF THAT HOWEVER IS TWO YEARS AND MINIMAL AMOUNT OF MONEY, IS LIMITING. SO IT ASKS A LOT TO INTEGRATE SEX AND GENDER INTO A TWO YEAR PROJECT IN A MEANINGFUL WAY, UNLESS YOU HAVE A LOT OF DATA ALREADY AND THEN YOU'RE SPENDING OFF WHICH IS FINE TOO, EXCEPT IF PART OF YOUR GOAL IS TO ATTRACT NEW PEOPLE IT'S AWFULLY HARD TO DO THAT IN TWO YEARS. SO I FOUND MYSELF WONDERING AS FUNCTION OF BEING OF TWO MINDS IF MAYBE THERE WAS THE POSSIBILITY BECAUSE WE CAN BE SO FLEXIBLE IN THE WAY WE MIGHT GO FORWARD WITH SOMETHING LIKE THAT. REALLY PROVIDING A LIMITED NUMBER OF RO1s. AND THINKING ABOUT IT FROM THAT PERSPECTIVE AS WELL. GIVING PEOPLE A LITTLE BIT MORE TIME TO DEVELOP SOMETHING. WITH A LIMITED NUMBER YOU CAN TRY IT OUT ALMOST AS DARE I SAY A PILOT TO SEE HOW WELL THAT IS TO ATTRACT NEW PEOPLE, IT ALSO DOESN'T RULE OUT POSSIBILITY OF SOMEBODY WHO HAS A WELL DEVELOPED PROGRAM OF RESEARCH OF MOVING INTO AN RO1 AS WELL FROM SCORE OR LARGER CENTER. >> THANK YOU. I CAN'T READ YOUR WRITING. >> SO I UNDERSTAND THIS IS FOCUSING ON THIS PARTICULAR FUNDING, IN THAT REGARD I WOULD LIKE TO REALLY MAKE A PITCH FOR THE LIFE SPAN PART OF THIS AND TALK ABOUT ADVERSE CHILDHOOD EXPERIENCES, AS SOMETHING THAT GETS INTRODUCED BECAUSE THIS IS SOMETHING THAT I THINK PLAYS A MUCH BIGGER ROLE AND TO SAY A COUPLE MORE THINGS WHEN WE TALK ABOUT DEPRESSION IN THOSE KINDS OF DIFFERENCES WE NEED TO TAKE INTO ACCOUNT DIAGNOSING. LIKE I THINK THE MALE BOYS, BASICALLY HAVE DIFFERENT WAY OF PRESENTING THEIR DEPRESSION COMPARED TO GIRLS. I THINK THAT'S MISSED IN THE DSM. THE OTHER THING I WANT TO SAY IS I THINK ADVERSE CHILDHOOD EXPERIENCES GO NOT ONLY THROUGH AND I THINK WE EXPERIENCED THAT TWO WEEKS AGO WHEN OLDER WOMEN IN THIS COUNTRY WERE TRIGGERED BIG TIME, IT'S AFFECTING THEIR HEALTH ALL THE WAY THROUGH AND UNTIL WE START TO REALLY RECOGNIZE THE POWERFUL EFFECT OF GENDER WE'RE NOT GOING TO GET TO A LOT OF THE THINGS WE WANT TO GET TO WITH WOMEN'S HEALTH -- WITH THE HEALTH OF WOMEN. AND OTHER GROUPS. >> >> SO AMY, THEN ANNA, THEN DR. GREGORY. I'M SORRY. SO IF Y'ALL DON'T MIND, RACHEL HAS TO LEAVE SO SHE'S GOING TO MAKE HER COMMENT BEFORE SHE SCOOTS. PUT YOUR MICROPHONE ON PLEASE. >> ON ANOTHER ASPECT OF THINGS, LOOKING AT BEHAVIOR CHANGE AND LOOKING AT CLINICAL TRIALS AND HOW TO RECRUIT AND RETAIN IN CLINICAL TRIALS WE FIND DIFFERENCES IN MEN AND WOMEN SO I WOULD -- THIS HAS BEEN OUR EXPERIENCE IN ONLINE RECRUITMENT USING SOCIAL MEDIA. SO I WOULD ARGUE THAT AN RO1 WOULD BE AN IMPORTANT CONSIDERATION TO GET ENOUGH FUNDING TO DO A LARGER CLINICAL TRIAL IN AREAS WHERE THERE'S ALREADY EXPERIENCED SCIENTISTS LOOKING AT CERTAIN TOPICS BUT THIS TIME COULD LOOK AT SOME OF THOSE DIFFERENCES. BUT WE HAVE SEEN DIFFERENCES IN RECRUITING OUR SAMPLE HOW WE APPROACH USING FACEBOOK AND OTHER SOCIAL MEDIA AND INTERNET IS A VERY, VERY IMPORTANT CONSIDERATION TO BE AT THIS TABLE. THAT'S HOW WE REACH THOUSANDS AND THOUSANDS OF PEOPLE WITH BOTH INTERVENTIONS AS WELL AS RECRUITMENT FOR CLINICAL TRIALS. >> THANK YOU. AMY. >> VERY EXCITING. I WOULD AGREE, THIS CONCEPT OF FOLLOWING ACROSS LIFE SPAN, I WISH WE HAD LONG LONGITUDINAL STUDIES, THAT'S A PROBLEM BUT STILL I LIKE THAT. WHAT I'M PARTICULARLY EXCITED ABOUT THOUGH IS THE OPPORTUNITY TO REALLY BRING PEOPLE INTO WOMEN'S HEALTH ARENA WHO MIGHT NOT HAVE THOUGHT ABOUT IT BEFORE BECAUSE OF THE FACT THIS SPANS INSTITUTES. I CAN'T TELL YOU HOW MANY CONCEPTS HAVE COME UP AT OUR INSTITUTION THAT WE CAN'T FIND A HOME FOR IT. THE PEOPLE WHO ARE GET TOGETHER WITH ORGANS FOR EXAMPLE THAT DON'T FIT INTO ONE INSTITUTE OR ANOTHER INSTITUTE AND THERE ARE SOME COMMON FUNDS FOR THAT, BUT VERY LIMITED EXAMPLE BEING FIBROSIS AND SCLERODERMA. CERTAINLY DISORDER RELEVANT TO WOMEN BUT THERE'S NOT ONE INSTITUTE THAT ENCOMPASS WORK WE'RE GOING TO DO SO ONE OF THE WAYS TO ATTRACT PEOPLE TOWARDS DOING THIS KIND OF RESEARCH IS TO GET THE WORD OUT ABOUT THE FACT THIS IS AN OPPORTUNITY TO DO YOUR WORK THAT BRINGS TOGETHER DISCIPLINES AND I'M PARTICULARLY EXCITED ABOUT THAT. >> THANK YOU. ANNA. DID YOU MAKE YOUR -- >> OKAY SORRY. >> WASN'T SURE WHEN YOU SAID ANNA WHICH ONE YOU MEANT. >> DR. LOPEZ THEN LANGER. >> SORRY, I AGREE WITH THE RO1 FUNDING AND THE OPPORTUNITY THAT BRINGS. WHAT I WANTED TO COMMENT ON IS PERHAPS ANOTHER -- I'M ALSO EXCITED MANY THE STRATEGIC PLAN ABOUT THE OPPORTUNITY FOR REALLY DEVELOPING PEOPLE. AND HOW IT'S SO IMPORTANT THAT WE HAVE RESEARCHERS THAT ARE COMING ON AND THAT WE'RE SUPPORTING I WONDER IF THERE COULD BE AN OPPORTUNITY JUST AS WE WERE TALKING ABOUT ACROSS INSTITUTES, TO WORK WITH THE CTSAs. BECAUSE THE CTSAs HAVE DEVELOPMENT OPPORTUNITIES FOR YOUNG RESEARCHERS AND COULD WE PARTNER WITH THEM IN GENDER SPECIFIC RESEARCH. >> INTERESTING IDEA. DR. LANGER. >> YES, I HAVE A QUESTION AND A COMMENT. THE QUESTION HAS TO DO WITH MEASUREMENT OF GENDER THAT IS NOT WELL DEVELOPED ROBUST IN BIOMEDICAL SCIENCES AS IT IS IN SOCIAL SCIENCES SO I WAS WONDERING WHETHER METHODOLOGICAL RESEARCH COULD BE PART OF THIS EFFORT BECAUSE I THINK IT WILL BE IMPORTANT IN ORDER TO MOVE THE FIELD FORWARD. SORRY FOR THE BLIND COMMENT BUT CONSIDERING WE TALK ABOUT POLITICS IN SCIENCE, I WONDER IF SUCH AN INITIATIVE, AN EFFORT WOULD BE PROTECTED OR NOT FROM SOME GENERAL DISCUSSION THAT IS GOING ON IN THE COUNTRY ABOUT GENDER. >> WE ARE ACTUALLY TALKING ABOUT THIS, WE OTHER LEANING FROM A SCIENTIFIC PLACE. I THINK ONE OF THE WAYS IT IS IMPORTANT FOR US AS SCIENTISTS CLINICIANS, AS HEALTH RELATED PROFESSIONALS, WE SOMETIMES USE THE SHORTHAND SEX AND GENDER, IT'S KIND OF SHORTHANDS. RIGHT? WE SHOULD START TALKING ABOUT WHAT WE REALLY MEAN BY GENDER IN DIFFERENT CONTEXT. SO WHEN I WAS LISTENING TO DR. COURT'S PRESENTATION, I WONDERED IF THE RESULTS FOR WOMEN IN THEIR 40s MIGHT BE DIFFERENT IF THEY WERE SUPERSTAR SOCCER PLAYERS IN THEIR TEENS VERSUS SEDENTARY GIRLS. THOSE ARE GENDERED BEHAVIORS. YOUR LEV OF SPORTS ACTIVITY, WHETHER YOU DERIVE SOCIAL BELONGING FROM BEING ON A TEAM, ALL OF THOSE AFFECTS, I DIDN'T SAY THE WORD GENDER BUT THAT IS A GENDERED BEHAVIOR. SO I THINK THAT IT'S INCUMBENT UPON US TO START TALKING ABOUT WHAT WE REALLY MEAN BY THAT BECAUSE I DON'T THINK SOME PEOPLE UNDERSTAND WHAT WE ARE SAYING, SOMETIMES WE ARE NOT SPEAKING THE SAME LANGUAGE AT THE SAME TABLE. YOUR POINT IS EXTREMELY WELL TAKEN REGARDING THE METHODOLOGICAL ISSUES THAT MARSHA MENTIONED AS WELL. SO IN GENERAL, YOU CAN'T WAIT UNTIL YOU HAVE EVERYTHING READY TO START SOMETHING BUT THERE MIGHT BE WAYS TO ENCOURAGE FURTHER DEVELOPMENT OF THOSE TOOLS AND I KNOW GENDER INNOVATIONS IS DOING INCREDIBLE WORK IN THAT SPACE. THE LIVES IN THE CONTEXT OF LIVES OF WOMEN, IF YOU'RE INVESTIGATING MICROVASCULAR DISEASE IN THE HEART BUT IN THE CONTEXT OF ADVERSE CHILDHOOD EXPERIENCES AND INFLUENCE, THAT IS A FUSION OF SEX AND GENDER. AND I DIDN'T SAY SEX OR GENDER. BECAUSE WE NEED TO DIVE DEEPER. THAT'S PART OF MY RESPONSE THERE. DR. GREGORY, HAD A QUESTION. DR. DEBREEZE LOOKS LIKE HE HAS A COMMENT. SO KIM THEN WENDY. >> YOUR MIC ON. I WANT TO FOLLOW-UP AND MAKE A POINT FOR HOW YOU MIGHT BE EVALUATING THIS FOA AND THAT I THINK EVALUATING ALL THE PROPOSALS AT ONE TIME IN SEP OPPOSED TO SENDING THEM ACROSS THE DIFFERENT -- >> THANK YOU. DR. BREWSER. >> TO BUILD ON WHAT DR. GREGORY SAID, THANK YOU VERY MUCH FOR YOUR APPRECIATION OF LIMITATIONS OF R-21 VERSUS RO1. SABB HAS BEEN ENCOURAGED SINCE 2016 AND I WOULD BE CONCERNED IF WE ONLY FOCUSED ON RO1s. WHAT WE HAVE BEEN DOING IS SAYING UNLESS THERE'S THIS AMOUNT OF MONEY WE'RE NOT GOING TO LOOK AT ALL THE SEX OR GENDER NUANCES. THIS IS AN OPPORTUNITY FOR NEW METHODOLOGY TO COME UP, APPRECIATE THE ISSUE ABOUT POWER AND HOW WE MIGHT DO THAT, THIS MIGHT BE AN OPPORTUNITY TO CREATE AN INCENTIVE FOR PEOPLE TO FIGURE OUT HOW TO DO THE SCIENCE WITH A SMALLER IN EACH GROUP. SO I WOULD STILL BE SUPPORTIVE OF R-21s BECAUSE THAT'S HOW A LOT OF PEOPLE GET THEIR START AND WE DON'T WANT TO LIMIT COMPETITION TO THOSE WHO ALREADY HAVE A LOT OF FUNDING AND WHO ALREADY HAVE A LOT OF -- (INAUDIBLE). >> DID YOU HAVE A COMMENT? >> I THINK I AGREE WITH THAT. I THINK MUCH OF THIS WILL BE EXPLORATORY AND ONE OF THE THINGS RISK RUNNING IF THIS GETS REVIEWED BY REGULAR PANELISTS AND THIS PROPOSALS COME ON THE TABLE WITH MANY PEOPLE NOT EVER REALLY HAVING THOUGHT ABOUT GENDER AND SEX THEY CAN GET LOST. IF YOU BRING IT TOGETHER AND THEY COME FROM DIFFERENT DISCIPLINES NOT ONLY WILL -- IS THE CHANCE THEY GET LOST SMALLER, YOU ALSO GIVE CROSS FERTILIZATION, GOOD PRACTICES STUDYING GENDER IN ONE FIELD, MIGHT HELP OTHER FIELDS DEVELOP SIMILAR PRACTICES. (OFF MIC) >> SORRY ON THE EXAMPLE THAT YOU GAVE THERE IS EIGHT OR NINE IN THAT ONE. SOMETIMES IT MAY TAKE SEVERAL YEARS, WHAT HAPPENS FIVE YEARS ARE THOSE R-21st DO THEY STILL NOW LOOK AT SEX OR GENDER DIFFERENCES IN THOSE ONES THAT CAME OUT FIVE, SIX YEARS AGO? SOMETIMES IT TAKES THAT LONG TO DEVELOP A PROGRAM. I LIKE THE IDEA OF THE R-21 BRINGING PEOPLE TO THE FIELD BUT THEY MAY NOT BE LONG ENOUGH. TO SEE THE DIFFERENCE IN TWO OR THREE YEARS. ESPECIALLY IF YOU DO ADVERSE CHILDHOOD EXPERIENCE OR TRANSGENERATIONAL EFFECTS. THOSE ARE GOING TO BE LONG GRANTS EVEN IF THE THEY'RE ANIMAL GRANTS. SO IT MAYBE YOU NEED TO WATCH WHAT YOUR MILESTONES ARE AND THEY MAY NOT -- YOU MAY NOT MEET THOSE FOR FIVE YEARS. EVEN IF IT'S A TWO YEAR GRANT. >> I WOULD SECOND THESE TWO MOST RECENT COMMENTS. AND JUST TO SLIGHTLY PLAY THE DEVIL'S ADVOCATE, YOU ARE ASKING NOW FOR GOING BEYOND SABB AND YOU WILL WANT TO FOSTER INTERDISCIPLINARY AND YOU HAVE TO ASK JUST LIKE WE ASKED EIGHT YEARS AGO WHERE ARE THESE GRANTS REVIEWED AFTER THE PILOT AFTER THE INITIAL. SO IS THERE A SIMILAR INITIATIVE TO GET THIS INTERDISCIPLINARY SEX AND GENDER INTO TRADITIONAL STUDY SECTIONS. I THINK YOU NEED TO TO THAT IN PARALLEL. >> DR. KLINE YOU ARE QUIET OVER THERE. >> I ABSOLUTELY AGREE, PART OF THE PROBLEM IS STUDY SECTION AND OFTEN DEPENDS ON DISCIPLINES. FOR MANY OF OUR DISCIPLINE THERE'S A LACK OF APPRECIATION AND IT'S A REAL CHALLENGE TO GET SEX AS A BIOLOGICAL VARIABLE LET ALONE ANYTHING MORE INTERDISCIPLINARY THAT INTERSECTS WITH GENDER FUNDED, IT WOULD BE WONDERFUL TO START TO SEE THE CENTER FOR SCIENTIFIC REVIEW, HAVE A STANDING STUDY SECTION COMMITTED TO SEX AND GENDER. >> I HAVE A QUESTION -- GO AHEAD CAROLYN, THEN MARSHA. >> I THINK THE DISCUSSION IS HELPFUL FOR ME, IF YOU DID HAVE A DEDICATED STUDY SECTION IT WOULD GET AROUND THE PROBLEMS THAT WE'RE TALKING ABOUT. IN TERMS OF THE MECHANISM BECAUSE THEN YOU WOULD HAVE PEOPLE ON THE STUDY SECTION WHO POTENTIALLY RECOGNIZE THE IMPORTANCE OF THE INTEGRATION OF SEX AND GENDER. I THINK THAT SOMEHOW -- THE IDEA IS NOT TO ME SO MUCH AN R-21 VERSUS RO1 AS MUCH AS IT IS HOW DO YOU GET PEOPLE STARTED AND/OR INVESTED IN THIS WORK IN A MEANINGFUL WAY. AND TO DO THE KIND OF THINGS THAT ARE IMPORTANT PEOPLE ARE MENTIONING IS NOT GOING TO TAKE TWO YEARS. IT WILL TAKE LONGER. SO I GUESS I FOUND MYSELF WONDERING, IT'S NOT SO MUCH THAT WE SHOULD -- FOCUSING ON THE MECHANISM AS MUCH AS FOCUSING ON THE GOAL. IF THE GOAL IS TO BRING PEOPLE INTO THE FIELD AND TO ALLOW THEM TO DEMONSTRATE SOMETHING OF VALUE THEN YOU MIGHT NEED SOMETHING LONGER THAN TWO YEARS. TO DEVELOP AN IDEA THAT INTEGRATE THESE THINGS. BUT IF YOU PUT THEM IN A TRADITIONAL STUDY SECTION AS THEY STAND NOW THEY WON'T DO WELL. SO MAYBE PART OF A STRATEGIC PLAN IS TRYING TO ASSESS THESE BY GROUP PREPAREDDED TO REALLY UNDERSTAND IMPORTANCE OF WHAT WE ARE TALKING ABOUT. >> AND FOLLOW UP ON SABR AND ON CAROLYN, I THINK WHEN WE START TO TALK ABOUT SEX AS A BIOLOGICAL VARIABLE YOU HAVE BUILT INTO THE LANGUAGE STRONG JUSTIFICATION IS NEEDED. SO I THINK THAT WHERE GENDER IS A CHALLENGE, ANIMAL PEOPLE NEED TO RECOGNIZE THERE'S GENDERED VARIABLES THE WAY ANIMALS ARE CAGED IS DIFFERENT BUT WHAT MADE ME A LITTLE UNHAPPY IN THAT -- THE SEX AS BIOLOGICAL VARIABLE IS CELLS DROPPED OUT OF WHAT WAS IN THE 2014 ISSUE AND I THINK WE NEED TO GET CELL BIOLOGISTS BECAUSE THE X CHROMOSOME IS REALLY IMPORTANT. IN SEX DIFFERENCES AND IT'S NOT ALL ABOUT SEX HORMONES. I THINK IF WE HAD SOMEPLACE WHEREBY THE TIME YOU ARE AT CELLS I DON'T THINK THERE'S TOO MUCH GENDER WE CAN TALK ABOUT. THERE MIGHT BE, I DON'T KNOW. BUT SOMEWHERE WHERE THE LANGUAGE IS BUILT IN THIS WHAT WE'RE TRYING TO GET PEOPLE TO DO IS TO THINK, THE WAY WE DO BIOLOGY IS MISSING KEY VARIABLES AND THAT WE NEED TO BE LOOKING AT SEX DIFFERENCES, LOOKING AT HOW THESE OTHER INFLUENCES AFFECT SO GENDER INFLUENCES AFFECT THE BIOLOGY SO MOSTLY I'M TALKING LANGUAGE GOING INTO WHATEVER YOU DO WHETHER R-21 OR RO1 WHATEVER IT IS TO START THE REALIZE WE HAVE BEEN MISSING IMPORTANT CONFOUNDING VARIABLES IN THE WAY WE DO SCIENCE. IT'S AFFECTING NOT ONLY THE HEALTH OF WOMEN BUT HEALTH OF MEN AND EVERYBODY IN BETWEEN. >> LET ME CLARIFY THAT CELL LINES ARE NOT COVERED BY SABB. PRIMARY CELLS ARE. THEY ARE COVERED. CELL LINES MORTALIZED CELL LINES ARE NOT COVERED. >> SO THEN I WASN'T CRITICIZING AS MUCH TRYING TO ADVANCE US TO BE LOOKING AT CELLS, THE SEX OF THE CELL WHICH IS REALLY ONE OF THE MOST PROFOUND STATEMENTS IN THE IOM, 2001 REPORT. REALLY A LOT MORE EMPHASIS ON THE X CHROMOSOME WHICH I THINK IS REALLY IMPORTANT. DR. MCCULLOUGH AGREES I THINK. WE WILL BE TRYING TO GET TOGETHER A LITTLE THINK TANK ABOUT WHY WHICH IS SOMETHING I CAN NEVER UNDERSTAND BUT I'M NOT A GENETICIST BY ANY STRETCH, WHY IN GWAS DATA REMOVED X CHROMOSOME, EVERY GWAS DATA INCLUDES NOTHING ON X AND Y. APPARENTLY THAT'S DIFFICULT BECAUSE OF SOFTWARE ISSUES AND BIOINFORMATIC ISSUES BECAUSE THEY ARE NOT GENETICALLY LOADED. I'M LIKE COME ON, WE HAVE TO FIGURE THIS OUT SO WE'LL TRY TO GET A GROUP OF PEOPLE TOGETHER TO TRY TO FIGURE OUT WHY WE ARE NOT ABLE TO DO THAT IN OUR GWAS STUDIES AND WHAT WE COULD REANALYZE IF WE HAVE THAT INFORMATION AND AT LEAST GOING FORWARD MAKE SURE THAT WE HAVE DETAILS ABOUT WHAT'S ON THE SEX CHROMOSOMES. >> SURE. >> SO IN THE WHI WE DID GWAS ON ALL THE AFRICAN AMERICAN HISPANIC WOMEN, THEY DIDN'T DO X AND Y BUT IT'S A MATT -- MATHEMATICAL THING SO WE HAVE A TEAM WORKING ON HOW YOU DO THAT. SO IT'S SOMETHING -- I DON'T KNOW HOW TO DO IT, I ONLY KNOW THE PEOPLE WHOLE SAID WE SHOULD DO IT FIGURED OUT HOW TO DO IT. HUNTINGTON WILLARD I WOULD RECOMMEND WE BRING INTO THIS. >> I LOVE THE IDEA OF HAVING A SPECIAL REVIEW SESSION JUST AS MUCH AS WE HAVE ET CETERA, ET CETERA. I WAS THINKING THAT -- WE ARE THINKING ABOUT R-2 1ES AND RO1s BUT THERE ARE HYBRIDSABLE I BELIEVE IT'S CALLED AN R-33. YOU REACH A GO NO GO STAGE. YOU CAN SEE YOU BUILD UP A TEAM THAT CAN GO ON AND DO A MUCH MORE INTEGRATED SITE. >> THANK YOU ALL, FOLK ON THE PHONE I WANT TO MAKE SURE I KNOW DR. PAGE WAS ON THE PHONE FOR A LITTLE WHILE AND IS THERE ANYBODY ON THE PHONE THAT WANTS TO MAKE A COMMENT? >> AMY POWERS IS ON THE PHONE AND RACHEL JONES. BUT WE ARE LISTENING IN AND WE'LL COMMENT IF SOMETHING COMES UP. >> THANK YOU BOTH. >> CAN WE SITE THIS STRATEGIC PLAN OR YOU WILL TELL US WHEN IT'S ALLOWED TO DISTRIBUTE? >> TODAY WE PRESENTED THE GOALS AND OBJECTIVES AND THE GUIDING PRINCIPLES AND YOU RECEIVED THAT INFORMATION IN YOUR INFO GRAPHIC. SO THAT IS PUBLIC DOMAIN, THE FULL STRATEGIC PLAN IS PENDING FINAL APPROVAL BY NIH LEADERSHIP AND AS SOON AS I HAVE THAT WHICH I DON'T ANTICIPATE IS GOING TO BE VERY LONG FROM NOW I WILL GIVE YOU THE SPECIFIC CITATION. YOU CAN LOOK AT OUR WEBSITE WHICH I BELIEVE HAS JUST OUR WEBSITE WITH/STRATEGIC PLAN AS WAY THE GO TO GET MORE INFORMATION. >> WE'LL USE ONE OF THOSE GRAPHICS THAT IS -- >> THIS IS ALL PUBLIC DOMAIN. >> EVERYTHING BEING PRESENTED TODAY. SO WE HAVE AN OPEN TIME NOW FOR YOU TO TALK ABOUT ANY ISSUES THAT YOU THINK YOU WANT TO BRING UP OF IMPORTANCE POTENTIAL FUTURE TOPICS FOR MEETINGS AND TOPICS THAT YOU ARE INTERESTED IN, ANYTHING YOU HEARD EARLIER, SOMETHING YOU DIDN'T HEAR EARLIER AND UPPED TO HEAR. SOMETHING YOU WOULD LIKE TO HAVE SOMEBODY FROM NIH COME AND SPEAK TO US ABOUT IN THE FUTURE. ARE THERE ANY POINTS ANYBODY WANTS TO RAISE IN THAT REGARD? DR. LOPEZ. >> AS WE THINK ABOUT INTERSECTIONS WE STILL TALK RACE ETHNICITY WHEN WE KNOW THAT RACE IS REALLY A SOCIAL CONSTRUCT, I'M WONDERING TO HAVE CONVERSATIONS THAT TALK ABOUT INTERSECTIONALLY THINKING GENERAL TUCK VARIATION. AND SO THAT WE'RE NOT THINKING ABOUT RACE AS MUCH BUT REALLY UNDERSTANDING THAT THERE'S SPECIFIC GENETIC VARIANT THAT MAYBE LINKED. THINKING ABOUT DIABETES DATA. WHAT THE IMPACT THAT MIGHT HAVE ON UNDERSTANDING OF ILLNESS AND DISEASE. >> AMERICAN INDIAN, ALASKA NATIVE DATA THAT DR. ROGERS PRESENTED WAS VERY DISTURBING AND QUITE DIFFERENT FROM ALL THE OTHER DATA PRESENTED. I HEAR YOU. OTHER IDEAS, DR. LANGER. >> FROM EARLY THIS MORNING I HEARD YOU MENTION THAT THE NEXT SYMPOSIUM WILL BE OBJECT JOURNAL -- IN THE US. IMPROVING THE -- >> MATERNAL HEALTH. LET'S PUT IT IN A POSITIVE. I CORRELATE -- SO I WOULD JUST LIKE TO SAY HAPPY TO HELP ANY WAY WE CAN, WE ARE WORKING EXTENSIVELY ON THE TOPIC. LOVE YOU FOR CHOOSING THAT. WE WILL DEFINITELY TAKE ADVANTAGE OF YOUR EXPERTISE SO WE ARE EXCITED ABOUT THAT TOPIC. >> THANK YOU. >> WE CAN DEFINITELY ADJOURN EARLY AND GIVE Y'ALL THE GIFTED OF TIME. THAT DOES MEAN I GET TO GET AN EXTRA HOUR THE NEXT TIME WE MEETINGS JUST JOKING. OUR NEXT MEETING IS YOU ARE HOLDING APRIL 9 AND 10 FOR THE 47th MEETING. MS. SPENCER THERE ANY LOGISTICAL OPERATIONAL ANNOUNCEMENTS WE NEED TO MAKE? >> NOT AT THIS TIME. IF YOU DON'T HAVE A CAB OR TRANSPORTATION BACK TO THE AIRPORT PLEASE CONNECT WITH ELIZABETH OR PETER WHO WILL BE AT THE FRONT DESK. THANK YOU ALL. WE ARE ADJOURNED. THANK YOU VERY MUCH, EVERYBODY.