WOULD LIKE TO CALL TO ORDER THE
MEETING AND I'M VIVIAN OTA WANG
AND EXECUTIVE SECRETARY OF THIS
COMMITTEE.
MEETING IS OPEN TO THE PUBLIC
VIA LIVE BROADCAST ON THE NIH
VIDEO NETWORK AND AVAILABLE FOR
FUTURE ON DEMAND VIEWING FOR THE
PUBLIC.
ONE NOTE FOR PEOPLE IN THE ROOM
TODAY, THERE IS AN IRREGULARITY
ON THE FLOOR WITH TAPE AND HAS
AN INCLINE SO YOU DON'T TRIP.
JUST WANTED TO BRING THAT TO
YOUR ATTENTION.
IF YOU'RE A MEMBER OF THE PUBLIC
PER THE FEDERAL REGISTER NOTICE
YOU MAY SUBMIT WRITING TO ME AND
WE'LL ADDRESS YOUR QUESTIONS
AFTER THE MEETING.
THIS MEETING IS HYBRID AND
ADVISORY MEMBERS ARE
PARTICIPATING IN PERSON AND
THROUGH ZOOM AND NOW A MESSAGE
TO OUR MEMBERS.
THIS IS BASICALLY A REMINDER
THAT YOU ARE SPECIAL GOVERNMENT
EMPLOYEES.
AS MEMBERS OF THIS FEDERAL
ADVISORY COMMITTEE YOUR SPECIAL
GOVERNMENT EMPLOYEES WHICH MEANS
YOUR SUBJECT TO THE SAME ETHICS
RULE THAT APPLY TO GOVERNMENT
EMPLOYEES AND THEY'RE TITLED
STANDARD OF ETHICAL CONDUCT FOR
EMPLOYEES OF THE EXECUTIVE
BRANCH.
YOU RECEIVED A COPY OF THIS
DOCUMENT WHEN YOU WERE
APPOINTED.
AT EVERY MEETING, WE'D LIKE TO
REVIEW THE STEPS 1:WE TAKE AND
PROCESSES WE FOLLOW TO IDENTIFY
AND ADDRESS ANY CONFLICT BETWEEN
YOUR PRIVATE RESPONSIBILITIES
AND PUBLIC INTERESTS.
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 FOR
WHETHER THERE'S REAL POTENTIAL
OR APPARENT CONFLICTS OF
INTEREST THAT COULD COMPROMISE
YOUR ABILITY TO BE OBJECTIVE IN
GIVING ADVICE.
IF YOUR NEED FOR SERVICES
OUTWEIGH THE CONFLICT OF
INTERESTS IDENTIFIED WE WILL
RECUSE YOU FROM A PARTICULAR
PORTION OF THE MEETING.
WE USUALLY WAIVE CONFLICTS OF
INTERESTS BECAUSE WE BELIEVE
YOUR ABILITY TO BE OBJECTIVE
WILL NOT BE AFFECTED BY YOUR
FINANCIAL INTERESTS AND RELY A
GREAT DEAL ON YOU.
YOU NEED TO BE ATTENTIVE DURING
MEETING TO THE POSSIBILITY AN
ISSUE COULD ARISE THAT COULD
AFFECT YOUR RESPONSIBILITY AND
YOU WILL BE ASKED TO RECUSE
YOURSELF FROM THAT PORTION OF
THE MEETING.
BEFORE INTRODUCTIONS I'D LIKE TO
REVIEW BEST PRACTICES FOR
PARTICIPANTS IN THE HYBRID
SETTING.
PLEASE FOR ALL OF YOU, PLEASE
MUTE YOUR MICROPHONES IF YOU'RE
NOT SPEAK.
WHEN SPEAKING, PLEASE STATE YOUR
NAME BEFORE MAKING COMMENTS,
MOTIONS OR RNGDS.
-- RECOMMENDATIONS.
IF IN PERSON, PLEASE MAKE SURE
YOU'RE MICROPHONE IS ON WHILE
SPEAK AND REFRAIN FROM DRAGGING
THE MICROPHONE ACROSS THE TABLE
AND PLEASE DO NOT LEAN BACK WHEN
SPEAKING INTO THE MICROPHONE.
IF ONLINE TRY TO USE A HEADSET
WITH A MICROPHONE WHEN SPEAKING
AND THAT IS THAT WILL USUALLY
RESULT IN THE CLEAREST TONE AND
LEAST AMOUNT OF FEEDBACK AND
ENCOURAGE TO YOU TURN ON YOUR
CAMERAS TO GET THE FULL VISUAL
EXPERIENCE OF US BEING IN FULL
COMMITTEE.
IF YOU HAVE A QUESTION OR WOULD
LIKE TO MAKE A COMMENT, PLEASE
RAISE YOUR HAND.
WHEN INDICATED, MEMBERS WILL
RAISE THEIR HANDS AND WE'LL VOTE
TO ACCEPT OR OBJECT OR REFRAIN
SO RAISE YOUR HAND IN ACCORDANCE
WITH YOUR RESPONSE AND WE'LL
SHARE THE ZOOM GALLERY DURING
THIS TIME TO SEE YOUR VOTE.
AS I GO THROUGH THE ROSTER, WHEN
YOU HEAR YOUR NAME, PLEASE
UNMUTE YOUR MIC AND INTRODUCE
YOURSELF BY NAME AND WHAT
INSTITUTION YOU REPRESENT ALSO,
IF YOU HAVEN'T ALREADY SIGN IN
AT THE SHEET AT THE FRONT TABLE.
DR. ANDERSON.
>> GOOD MORNING.
DR. ANDERSON REPRESENTING THE
FRED HUSHINSON CANCER CENTER IN
SEATTLE.
>> DR. MILLANS.
>> I'M FROM COLUMBIA UNIVERSITY
MELMAN'S SCHOOL OF PUBLIC
HEALTH.
>> DR. UNYENYA.
>> I'M FROM THE SOCIETY FOR
WOMEN'S HEALTH RESEARCH.
>> DR. HIGGINS.
>> DR. CHATSI.
>> THE CHAIR OF RADIATION
ONCOLOGY.
>> DR. JONES.
>> I'M ANDREAENS AND I'M A
PROFESSOR IN THE DEPARTMENT OF
OBSTETRICS AND GYNECOLOGY AT THE
UNIVERSITY OF NORTH CAROLINA
CHAPEL HILL.
>> DR. KNOWEL.
>> I'M AN ASSOCIATE PROFESSOR IN
THE DEPARTMENT OF COMPARATIVE
SCIENCES AT LOUISIANA STATE
UNIVERSITY.
>> DR. SADOVSKY.
>> I'M FROM THE UNIVERSITY OF
PITTSBURGH.
>> DR. SHARPS.
MAYBIAN LINE.
-- MAYBE ONLINE.
>> I'M PROFESSOR AT JOHNS
HOPKINS UNIVERSITY SCHOOL OF
NURSING.
>> DR. SIMON.
>> I'M MELISSA SIMON OB-GYN AT
NORTHWESTERN.
>> PLEASE JOIN US AT THE TABLE.
>> DR. TEMPLETON.
>> I'M FROM PROFESSOR OF
ORTHOPEDIC SURGERY AND ASSOCIATE
DEAN FOR CONTINUING MEDICAL
EDUCATION AT THE KANSAS IN
KANSAS CITY.
>> DR. BRUEGL.
NEXT SLIDE.
I WANT TO ACKNOWLEDGE AND THANK
OUR MEMBERS WHO WILL BE RETIRING
FROM OUR IN THE COMING MONTHS.
THESE MEMBERS HAVE EACH SERVED
DILIGENTLY ON ACRWH THE PAST
FOUR YEARS.
THESE ARE DR. GOTMAN.
DR. SADOVSKY AND DR. TEMPLETON.
THANK YOU FOR YOUR SERVICE.
I'D ALSO LIKE TO RECOGNIZE OUR
PENDING MEMBERS.
THEY'LL JOIN THE ADVISORY GROUP
IN THE UPCOMING WEEKS PENDING
THEIR CLEARANCE.
THEY ARE AYUSH GIRI, DR
DR. OTOTOKUN AND WHY FATIMA
STANFORD.
WE LOOK FORWARD TO WELCOMING
THEM TO THE COMMITTEE.
YOU WERE EACH SENT THE MINUTES
FROM OCTOBER 18, 2023 FOR
REVIEW.
ONLY FULL MEMBERS MAY VOTE.
SO IF YOU'RE NOT A MEMBER OF
ACRWH, PLEASE RESTRAIN FROM
VOTING.
IS THERE A MOTION TO ACCEPT THE
MINUTES AS WRITTEN?
DR. SADOVSKY SUBMITTED THE
MOTION.
FOR ALL ACCEPTING, PLEASE RAISE
YOUR HANDS NOW.
CAN WE HAVE THE GALLERY TO SEE?
FOR ALL OPPOSED RAISE YOUR HANDS
NOW.
ALL ABSTAINING, RAISE YOUR
MANDZ.
-- HAPPENED.
ERIC, HAVE THE VOTES BEEN
RECORDED?
WHAT IS THE VOTE NUMBER?
THANK YOU THE OCTOBER 2023
MEETING MINUTES HAVE BEEN
ACCEPTED.
YOU WERE ALL SENT A DRAFT OF THE
2024, 2028 DRAFT OF STRATEGIC
PLAN TO REVIEW.
I'D LIKE TO OPEN THE FLOOR FOR A
FEW MINUTES FOR MEMBERS'
COMMENTS ABOUT THE DRAFT.
YES, DR. SIMON.
>> I HAVE SEVERAL COMMENTS.
UNTIL WHEN DO I HAVE TO SUBMIT?
>> UNTIL THE END OF THE WEEK
WOULD BE MINE.
DOES ANYBODY HAVE ANYTHING TO
SHARE.
HELLO, DR. TEMPLETON.
>> THANK YOU.
THIS IS AMAZING PIECE OF WORK.
I APPRECIATE THE OPPORTUNITY TO
REVIEW THIS.
I DID HAVE COMMENTS YESTERDAY
AND TO SUMMARIZE TWO AREAS, ONE
THE
I TOTALLY SUPPORT THAT BUT WE TO
THE WOMEN IN LATE CAREER ALSO
DON'T GET SUPPORTED AND PROBABLY
HAVE LESS SUPPORT THAN THOSE IN
EARLY CAREER WOMEN AND MEN AND
LATE CAREER TEND TO BECOME
INVISIBLE WITHIN THEIR
DEPARTMENTS AND INSTITUTIONS.
THEY LOSE THAT SUPPORT JUST WHEN
THEY SHOULD BE RISING TO
LEADERSHIP POSITIONS.
SO THAT WAS MY OTHER
RECOMMENDATION AS WE LOOK AT
SUPPORTING WOMEN'S CAREERS IN
THE BIOMEDICAL AREAS IT NEEDS TO
BE CAREER LONG NOT ONLY
SPECIFICALLY FOR MID CAREER
WOMEN.
THANK YOU.
>> THANK YOU ZECH.
>> I SUGGEST UNDER THE ASPECT OF
DATA SHARING MORE DATA ELEMENTS
PARTICULARLY AROUND THE
TRANSITION TIMES IN WOMEN THAT
ARE UNDER DEVELOPED OR NOT
STANDARDIZED SO FOR DATA SHARING
WE WOULD HAVE THE BETTER
OPPORTUNITIES TO POOL OUR DATA
IF WE HAD COMMON DATA ELEMENTS.
>> THANK YOU.
>> I WANTED TO COMPLIMENT
DR. TEMPLETON ON HER POINT AND
IT HELPED ME UNDERSTAND ISSUES
I'M SEEING IN OUR OWN DEPARTMENT
AND NOT FAMILIAR.
>> THANK YOU.
ANYONE ELSE.
>> UNDER ENGAGEMENT IN THE GOAL
5 HAPPY TO SEE IN PRAGMATIC
TRIALS AND WONDERED IF THAT
COULD BE EXPANDED A LITTLE BIT
MORE TO INCLUDE OTHER DESIGNS
AND IMPLEMENTATION SCIENCE.
LIKE HYBRID 1 AND 2 AND HAPPY TO
SEE THAT BUT MAYBE A LITTLE
EXPANSION THERE.
>> THANK YOU.
ANYONE ELSE?
IS THERE A MOTION ON THE TABLE
TO ACCEPT THE 2024, 2028
STRATEGIC PLAN AS WRITTEN?
DO I HEAR A SECOND?
WE HAVE A COUPLE SECONDS.
DR. ANINYE AND DR. ANDERSON.
ALL ACCEPTING RAISE YOUR HANS
NOW.
-- HANDS NOW.
THANK YOU.
ALL OPPOSED IN THE MOTION PLEASE
RAISE YOUR HANDS.
ALL ABSTAINING RAISE YOUR HANDS.
>> 10 IN FAVOR AND ONE
ABSTAINING.
>> THANK YOU.
THE 2024-2028 STRATEGIC PLAN ON
RESEARCH FOR THE HEALTH OF WOMEN
HAS BEEN ACCEPTED WITH 11 VOTES
AND ONE ABSTAINED.
I WOULD NOW LIKE TO ACKNOWLEDGE
DR. NORISI WHO WAS THE EXECUTIVE
SECRETARY.
AS YOU KNOW SHE HAS BEEN
HOLDING THE FORT DOWN DURING
COVID AND ORGANIZING THE
IMPORTANT PATH OF THE WORK OF
THIS GROUP.
WHEN I JOINED THE OFFICE AND I
WAS OVERWHELMED WHEN THEY SAID I
HAD TO FOLLOW HER FOOTSTEPS SO
JUST A SMALL TOKEN AND IT YOU
FOR YOUR SERVICE AND A WAS
TRYING TO FIND THE NORTH STAR
YOU MADE TO PUT THE MEETING
TOGETHER.
THANK YOU.
>> I SAID YOU ONLY DID IT FOR
ONE YEAR.
IT WAS A PLEASURE TO WORK WITH
ALL OF YOU AND THE PREVIOUS
MEMBERS AND YOU'RE JUST A GREAT
GROUP AND WE RELY ON YOU SO
HEAVILY.
IT WAS AN HONOR AND PRIVILEGE TO
SERVE IN THAT ROLE.
THANK YOU AGAIN FOR
ACKNOWLEDGING VIVIAN WILL BE
BETTER THAN ME.
>> I'M NOT SURE ABOUT THAT BUT
THANK YOU.
>> NOW I'D LIKE TO INTRODUCE
DR. JANINE CLAYTON.
>> GOOD MORNING EVERYONE.
DELIGHTED TO BE WITH YOU ALL.
I WANT TO ACKNOWLEDGE
DR. CHRISWILL JOINED US AND
SEVERAL I.C. DIRECTORS WILL BE
IN AND OUT TODAY THANK YOU FOR
JOINING, LINDSEY.
WE APPRECIATE THAT.
IT'S MY PLEASURE TO GIVE THIS
DIRECTOR'S REPORT TWICE A YEAR
TO SHARE UPDATES ON THE WORK
OFFICE RESEARCH OF WOMEN'S
HEALTH HAS DONE IN COLLABORATION
WITH THE SEVEN INSTITUTES AND
CENTERS AT NIH AND MULTIPLE
OFFICES.
I'LL GIVE AN ORWH AND NIH UPDATE
AND POLICY AND SCIENTIFIC
UPDATES AND UPDATE ON CAREERS
AND THEN CLOSE.
I BELIEVE THIS SECTION ENDS AT
10:30.
CONFIRM THAT IF YOU WOULD.
THANK YOU.
I DO LIKE TO ALWAYS BEGIN WITH
DATA.
WE ARE A DATA-DRIVEN
ORGANIZATION.
IT DRIVES EVERYTHING WE DO AND
IS OUR WHY.
WHAT WE HAVE SEEN IS THAT OVER
THE LAST 20 YEARS WOMEN HAVE
EXPERIENCED GREATER INCREASES IN
ALCOHOL USE PROBLEMS THAN MEN.
SO ON THE TOP LEFT YOU SEE
PRE-COVID ALCOHOL INVOLVED
SUICIDE INCREASED SIGNIFICANTLY
FOR WOMEN AND ALSO FOR MEN AGE
35 TO 64.
THIS IS BEFORE THE COVID
PANDEMIC.
DURING THE PANDEMIC, THIS
NATIONAL INSTITUTE ON ALCOHOL
ABUSE AND ALCOHOLISM FUNDED
STUDY SHOWED A REDUCTION IN THE
AVERAGE NUMBER OF DRINKS PER DAY
FOR MEN AND TO CHANGE OR SLIGHT
INCREASE FOR WOMEN IN THE DOTTED
LINE SHOWN ON THE RIGHT.
BOTTOM LEFT, THIS IS CDC DATA,
DEATHS DUE TO EXCESSIVE ALCOHOL
USE, THE FIRST DATA POINT IS
2016 TO 2017 TO 2020 TO 2021 AT
THE PEAK OF THE PANDEMIC.
AND YOU SEE A 35% INCREASE IN
DEATHS RELATED TO EXCESSIVE
ALCOHOL USE FOR FEMALES AND
26.8% INCREASE FOR MALES.
THE BOTTOM LINE IS TOGETHER MEN
AND WOMEN HERE THIS RESULTS IN
ALMOST 500 EXTRA DEATHS PER DAY
RELATED TO EXCESSIVE ALCOHOL
USE.
CLEARLY A CHALLENGE AND ISSUE
FOR OUR COUNTRY AND THE WORLD.
AND I WANTED TO DEMONSTRATE
THROUGH THIS DEPICTION OF SEX
DISAGGREGATED DATA HOW IMPORTANT
IT IS TO LOOK AT IT BY SEX TO
BETTER UNDERSTAND AND TARGET OUR
INTERVENTIONS AND PREVENTION
STRATEGIES APPROPRIATELY.
I ALWAYS UPDATE YOU ON
LEADERSHIP CHANGES AND IT'S MY
PRIVILEGE TO INTRODUCE DR
DR. SHANMUGAM IS HERE AND WE
WELCOME YOU AND COMES TO US FROM
MOST RECENTLY GEORGE WASHINGTON
UNIVERSITY AND HAS A
DISTINGUISHED CAREER IN
RHEUMATOLOGY AND HAS BEEN AN NIH
FUNDED INVESTIGATOR AND ONE AREA
OF EMPHASIS HAS BEEN ON SCLE
SCLERODERMA AND PLEASED TO HAVE
YOU YOU ON BOARD AND WE
INTRODUCED ELIZABETH BARR FOR
THE INTERDISCIPLINARY RESEARCH
SECTION AND SHE'S HERE IN THE
GALLERY WAVING.
WE'RE EXCITED TO WELCOME
DR. BARR IN THIS ROLE.
THESE BEEN A RESEARCH PROGRAM
OFFICER IN THE ORWH SECTION AND
HAD A Ph.D. FROM THE UNIVERSITY
OF WISCONSIN-MADISON AND AT THE
UNIVERSITY OF BALTIMORE COUNTY
WORKING ON IN THE DISCIPLINARY
CROSS-SECTOR PROJECTS TO
INCREASE WOMEN'S ENGAGEMENT IN
CHIN CKCAL -- CLINICAL RESEARCH
AND HAS BEEN A LEADER IN THE HIV
FIELD AND WOMEN.
WELCOME TO OUR SENIOR LEADERSHIP
TEAM.
I'D LIKE TO PROVIDE THE
LEADERSHIP CHANGES THAT OCCURRED
SINCE WE LAST MET.
DR. SCHWETZ IS NOW THE NIH
DEPUTY DIRECTOR FOR PLANNING AND
STRATEGIC INITIATIVES AND WILL
BE JOINING US LATER TO GET TO
MEET HER.
DR. RATHMELL HAS BEEN NAMED THE
DIRECTOR OF THE NATIONAL CANCER
INSTITUTE AND ACTING DIRECTOR OF
THE NATIONAL INSTITUTE OF MENTAL
HEALTH WITH DR. JOSH GORDON'S
ANNOUNCEMENT OF HIS DEPARTURE.
AT THE LAST MEETING I INTRODUCED
DR. BERTAGNOLLI TO YOU AND HAS
HIT THE GROUND RUNNING AND
SELECTED SEX DIFFERENCE AS A
TOPIC FOR HER TWO BLOGS SO FAR
AND HAS HAD MULTIPLE BLOGS AND
WE'RE EXCITED AND AT LEAST TWO
OF 15 HAVE BEEN FOCUSSED ON
RELEVANCE TO WOMEN'S HEALTH AND
SEX DIFFERENCES.
WE NOW HAVE WE HAVE WOMEN I.C.
DIRECTS AN IT'S IMPORTANT TO
NOTE AS WE GROW OUR LEADERSHIP
HERE AND AROUND THE COUNTRY.
ADDITIONAL LEADERSHIP UPDATES,
DR. FINZE IS ACTING AND
DR. PASIAKOS IS IN OFFICE OF
SUPPLEMENTS AND DR. BRENNER A
NEW OFFICE WITHIN THE DIVISION
OF PROGRAMMING AND STRATEGIC
INITIATIVES AND DR. JORGENSON
HAS BEEN NAMED THE NIH ASSOCIATE
DIRECTOR FOR SCIENCE POLICY AND
THE DIRECTOR OF THE NIH OFFICE
OF SCIENCE POLICY.
AND WE WELCOME THEM ALL AND LOOK
FORWARD TO WORKING WITH THEM
ALL.
OTHER NEWS ACROSS NIH I'M
EXCITED TO SHARE THERE'S A NEW
RCDC CATEGORY FOR MENOPAUSE
RESEARCH.
THAT THIS WILL ALLOW US TO TRACK
MENOPAUSE AND EXPORT
EXPENDITURES RELATED TO
MENOPAUSE TRANSPARENTLY TO THE
PUBLIC.
THERE'S A VARIETY OF OTHER RCDC
TERMS ON THE SLIDE AND I WANT TO
DRAW YOUR ATTENTION TO HEALTH
DISPARITIES AND RACIAL OR ETHNIC
MINORITY HEALTH RESEARCH, HEALTH
DISPARITIES RESEARCH AS A
SEPARATE CATEGORY AND RACIAL AND
ETHNIC MINORITY HEALTH RESEARCH
AS A SEPARATE CATEGORY AND
DELINEATED FURTHER IS WORKFORCE
DIVERSITY AND OUTREACH AS WELL
AS BUILDING RESEARCH CAPACITY.
SO THIS WILL PROVIDE ADDITIONAL
GRANULARITY AND TRANSPARENCY TO
OUR REPORTING.
YOU'VE HEARD ABOUT THE NIH
COMMUNITY PARTNERSHIPS TO
ADVANCE SCIENCE FOR SOCIETY OR
COMPASS PROGRAM.
IT'S BEEN MY PLEASURE TO SERVE
AS CO-CHAIR ON THIS GROUP.
THIS IS A COMMON FUND PROGRAM
AND I HAVE UPDATES FOR YOU
TODAY.
THE PURPOSE OF THE PROGRAM IS TO
CATALYZE, DEPLOY AND EVALUATE
COMMUNITY-LED HEALTH EQUITY
STRUCTURAL INTERVENTION LEVERAGE
PARTNERSHIPS ACROSS SECTORS.
IN ADDITION, A SECONDARY GOAL IS
TO DEVELOP A NEW HEALTH EQUITY
RESEARCH MODEL FOR THIS
COMMUNITY-LED MULTI-STRUCTURAL
RESEARCH FOR NIH AND OTHER
FEDERAL AGENCY.
THE PROGRAM DURATION IS SET AT
10 YEARS WITH AN APPROXIMATE
BUDGET OF $10 MILLION FOR THE
FIRST FIVE YEARS.
AS YOU MIGHT RECALL COMPASS HAS
THREE COMPONENTS.
THE FIRST IS COMMUNITY-LEAD
STRUCTURAL INTERVENTIONS AND 25
AWARDS WERE MADE IN 2023.
THE SECOND THE COMPASS
COORDINATING CENTER AND THE
THIRD IS THE HEALTH EQUITY
RESEARCH HUB COMPONENT AND WE
EXPECT UP TO FIVE AWARDS IN
2024.
THE COMMUNITY-LED INTERVENTIONS
ADDRESS FIVE DIFFERENT TYPES OF
STRUCTURAL FACTORS, COMMUNITY
HEALTH CARE, SOCIAL AND CULTURAL
CONTEXT, NEIGHBORHOOD AND BUILT
ENVIRONMENT AND ECONOMIC
DEVELOPMENT OR NUTRITION AND
FOOD ENVIRONMENTS.
AND I'M GOING TO GIVE YOU A
HIGHLIGHT OF THREE OF THE
CHESSIS AND LOOK FORWARD TO
UPDATING YOU MORE IN THE FUTURE.
THE FIRST IS THE PARTNERSHIP TO
OPTIMIZE WOMEN'S EQUITY AND
MATERNAL AND INFANT HEALTH.
THESE ARE COMMUNITY
ORGANIZATIONS RECEIVING THESE
AWARDS AS DELTA HEALTH ALLIANCE.
THAT'S PARTNERING WITH WESLEY
JAMES AND JONATHAN BENNETTE AT
THE UNIVERSITY OF MEMPHIS.
THIS INVESTIGATOR AND GROUP IS
LOOKING AT MISSISSIPPI'S BIRTH
AND MATERNAL HEALTH DISPARITIES
BY PROVIDING INFORMATION AND
CARE FOR PARTICIPANTS FROM THE
PRE-PREGNANCY PHASE TO
POSTPARTUM IN RURAL AND
LOW-INCOME SETTINGS.
TRAINING IS PROVIDED TO
CLINICIANS TO BETTER TAILOR
RECOMMENDATIONS TO FIT THE NEEDS
OF PATIENTS AS WELL AS
ADDRESSING ECONOMIC STABILITY
THROUGH IMPLEMENTING A MATERNAL
LEAVE STIPEND AS A STRUCK
INTERVENTION.
THE HUMANITARIAN HEALTH CARE
NETWORK BRINGING THE MOST
VULNERABLE TO CARE LED BY
LADIANA GARCIA IN SOUTHERN TEXAS
AND LOOKS AT WAYS TO PROVIDE
MEDICAL CARE FOR HIGH-RISK
CHILDREN AND LATE-TERM PREGNANCY
MOTHERS ALONG THE SOUTHERN
BORDER OF TEXAS AND CONNECTING
THEM TO MANAGEMENT INCLUDING
CASE WORKERS AND CULTURALLY
PROFICIENT PATIENT NAVIGATORS
AND THE PHYSICIANS AND CARE
PROVIDERS.
THE THIRD IS THE PUERTO RICO
COLLABORATIVE ADVANCEMENT OF
RESEARCH, INNOVATIONS AND BEST
PRACTICES FOR YOUTH AND
FAMILIES.
THIS IS LED BY A RESEARCH
PARTNER AT THE UNIVERSITY OF
PUERTO RICO AND GROUPO NEXOS
LOOKING AT THE JUSTICE SYSTEM
AND HEALTH CARE ACCESS AND
EDUCATION AND ECONOMIC AND
COMMUNITY DEVELOPMENT.
AND THIS PROJECT IS AIMING TO
REDUCE HEALTH DISPARITIES BY
LOOKING AT CHILD POVERTY AND A
MULTI-LEVEL INITIATIVE AND
ADDRESSING A VARIETY OF AREAS
INCLUDING QUALITY OF LIFE
MEASURES AND THIS ADDRESSES
THREE OF THE STRUCTURAL DOMAINS
IDENTIFIED AS PART OF THE
COMPASS PROGRAM.
I'D LIKE TO PROVIDE YOU WITH
POLICY AND SCIENTIFIC UPDATES.
IT'S MY PLEASURE TO SHARE THE
NEWS WITH YOU PRESIDENT JOE
BIDEN AND THE FIRST LADY
ANNOUNCED THE FIRST EVER FULL
WHITE HOUSE INITIATIVE ON
WOMEN'S HEALTH RESEARCH.
I WAS EXCITED AND HONORED TO BE
THERE WITH DR. BERTAGNOLLI WHEN
THE PRESIDENT SIGNED THE
PRESIDENTIAL MEMO TO ANNOUNCE
THE EFFORT AND CHALLENGE
EXECUTIVE AGENCIES AND PARTS OF
THE WHITE HOUSE TO COME UP WITH
RECOMMENDATIONS ON TANGIBLE
ACTIONS THAT THE U.S. GOVERNMENT
COULD TAKE TO ADVANCE WOMEN'S
HEALTH RESEARCH.
WE HAD TO COME UP WITH CONCRETE
RECOMMENDATIONS WITHIN 45 DAYS,
WHICH WE DID, TAKING A TARGETED
APPROACH TO ENGAGE MULTIPLE
SECTORS AND DRIVE INNOVATION.
THEN IN MARCH AND I WAS WITH TO
THE VICE PRESIDENT AND SECOND
GENTLEMAN WHERE EXECUTIVE ORDER
WAS SIGNED TO ADVANCE WOMEN'S
HEALTH RESEARCH AND INNOVATION.
THE KEY POINTS RELATED TO THIS
ARE PRIORITIZING INVESTMENTS IN
WOMEN'S HEALTH RESEARCH,
INTEGRATING WOMEN'S HEALTH
ACROSS THE FEDERAL RESEARCH
PORTFOLIO, THIS IS MULTIPLE
AGENCIES ACROSS THE GOVERNMENT
AND ASSESSING UNMET NEEDS FOR
WOMEN'S HEALTH RESEARCH AND
YOU'LL HEAR FROM THE CHAIR OF
THE INITIATIVE AND SHE'LL
DELINEATE DETAILS SO I'M SURE
WE'LL HAVE ROBUST DISCUSSION
LATER.
THE FIRST LADY VISITED MOREHOUSE
SCHOOL OF MEDICINE AND THE CEO
OF MOREHOUSE IS FEATURED HERE
AND IS A FORMER ADVISORY MEMBER
AND THE FIRST LADY SAID, QUOTE,
WE HAVE A CLARE GOAL TO
FUNDAMENTALLY CHANGE OUR NATION
APPROACHES AND FUND WOMEN'S
HEALTH RESEARCH.
THERE ARE BIG GAPS IN RESEARCH
ON DISEASES AND CONDITIONS THAT
ONLY AFFECT WOMEN THAT
DISPROPORTIONATELY AFFECT WOMEN
OR AFFECT WOMEN AND MEN
DIFFERENTLY, END QUOTE.
I WAS EQUALLY HONORED TO JOIN
THE FIRST LADY WHEN SHE VISITED
RESEARCH TRIANGLE IN NORTH
CAROLINA TO HELP DISSEMINATE THE
EXECUTIVE ORDER JOINED BY THE
GOVERNOR AND MAYOR OF DURHAM
NORTH CAROLINA AS WELL
INVESTIGATORS AND LEADERS IN
INNOVATION IN THE PRIVATE
SECTOR.
HERE SHE SAID SO MANY OF US AND
THE WOMEN IN OUR LIVES SUFFER
FROM HEALTH CONDITIONS FOR WHICH
WE SIMPLY DON'T HAVE THE ANSWERS
OR SOLUTIONS.
I WAS ALSO EXCITED TO BE JOINED
BY DR. PERRY WHO SPOKE AT THE
LAST YEAR'S SYMPOSIUM ON
MENOPAUSE AND MID LIFE HEALTH
AND IS A CHAIR AT THE UNIVERSITY
OF NORTH CAROLINA CHAPEL HILL.
AND IN ALIGNMENT WITH THE WHITE
HOUSE INITIATIVE ON WOMEN'S
HEALTH RESEARCH, NIH ISSUED A &
ASSOCIATES SPECIAL INTEREST IN
RECEIVING RESEARCH APPLICATIONS
FOCUSSED ON DISEASE AND
CONDITIONS THAT PREDOMINANTLY
AFFECT WOMEN LIKE AUTO IMMUNE
AND PRESENT AND PROGRESS
DIFFERENT OR FEMALE SPECIFIC
LIKE ENDOMETRIOSIS AND THIS IS
SOMETHING VIRTUALLY EVERY CENTER
HAS SIGNED ON TO AND MULTIPLE
OFFICES.
IT'S LINKED TO ALL THE NIH
PARENT FUNDING OPPORTUNITIES.
SO THIS ALLOWS BROAD MECHANISMS,
MULTIPLE PATHWAYS FROM MULTIPLE
TOPICS AND DISCIPLINES
INVESTIGATORS IT APPLY FOR
RESEARCH TO ADDRESS EVERY ASPECT
OF WOMEN'S HEALTH ACROSS THE
BOARD.
FIRST RECEIVE DATE IS MAY 6
AROUND THE CORNER.
WE ALSOED -- ALSO CONTRIBUTED
TO OTHER SECTORS IN THE POLICY
SPACE.
THERE'S A BLUEPRINT ESTABLISH
TASK FORCE FROM THE WHITE HOUSE
TO ADDRESS ONLINE HARASSMENT AND
ABUSE.
WE WERE PRIVILEGED TO
PARTICIPATE AND MAKE REMARKS AT
THE UNDERSTANDING AND ADDRESSING
THE HEALTH IMPACTS OF ONLINE
ABUSE AND HARASSMENT WORKSHOP.
THE REASON WHY THIS IS SO
IMPORTANT IS THAT FOUR IN 10
ADULT AMERICANS EXPERIENCE
ONLINE HARASSMENT AND IT'S A
GROWING NUMBER.
ONLINE HARASSMENT
DISPROPORTIONATELY AFFECTED
WOMEN AND GIRLS AND HALF OF
GIRLS 15 TO 17 OVER HALF HAVE
EXPERIENCED OVER ONE IN SIX
CYBER BULLYING BEHAVIOR.
IT'S ONE WAY DATA AND CAN INFORM
POLICY AND HOW POLICY CAN MAKE
AN IMPACT.
THIS WAS WIDELY VIEWED AND
PICKED UP BY THE MAINSTREAM
MEDIA AS WELL.
THIS IS ANOTHER MOMENT WHERE I
GET TO THANK YOU AS ADVISORY
COMMITTEE MEMBERS FOR SOME OF
THE WORK YOU'VE DONE.
THE REPORT OF THIS ADVISORY
COMMITTEE OF RESEARCH ON WOMEN'S
HEALTH AND THE NIH REPORT AND
THE FY21-22 REPORT WAS RELEASED.
THIS REPRESENTS SCIENTIFIC
ADVANCEMENTS THE INSTITUTES AND
CENTERS SUPPORTED.
IT PROVIDE A SUMMARY OF RESEARCH
AND TO OUR COMPLIANCE WITH
POLICY.
YOU'LL RECEIVE A FULL UPDATE
FROM THE NIH INCLUSION POLICY
AND DR. DAWN CORBETT WHO IS HERE
AND PROVIDE DATA ON WORKFORCE
DEMOGRAPHICS OF NIH SCIENTISTS
AS WELL AS THE DEMOGRAPHICS OF
NIH GRANTEES ARE INCLUDED IN THE
REPORT.
AND FOR THE FIRST TIME WE
CREATED A SECTION CALLED
CROSS-CUTTING INTEGRATIVE TOPICS
IN RESEARCH.
EVERY INSTITUTE AND CENTER AT
NIH SUPPORTS WOMEN'S HEALTH
RESEARCH ALIGNED WITH THEIR
RESPECTIVE MISSION AREAS AND
THERE'S TOPICS LIKE AUTO IMMUNE
DISEASE AND SOCIAL DETERMINATES
THAT OVERLAP.
WE PULLED THE TOPICS AGING ON
AUTO IMMUNE DISEASE AND MENTAL
HEALTH AND MORBIDITY AND
MORTALITY, SOCIAL DISTANCES AND
WHERE IMPACT TO CONVEY IN AN
INTERDISCIPLINARY CROSS-CUTTING
WAY.
I WANT TO THANK THE ADVISORY
COMMITTEE MEMBERS FOR AMAZING
WORK AND THIS IS YOUR REPORT YOU
DO WITH US ON BEHALF OF NIH AND
WE'RE GRATEFUL FOR YOUR EFFORTS
AND TO THE INSTITUTES AND
CENTERS AND OFFICES THAT ALL
SUPPORT WOMEN'S HEALTH RESEARCH.
IT'S FANTASTIC TO SEE THE
SCIENTIFIC ADVANCE IN A SINGLE
PLACE.
THE INNOVATION EQUITY FORUM IS
ANOTHER ACTIVITY I'D LIKE TO
SHOUT OUT.
MEMBERS FROM DIVERSE BACKGROUNDS
AND THE AIM WAS TO FORM THIS
BROAD MULTIDISCIPLINARY GROUP
WITH EXPERTISE FROM DIFFERENT
SECTORS BY DIVERSE PERSPECTIVES
AND HAVE AN IMPACT BY HAVING AN
INCLUSIVE, GLOBALLY FOCUSSED
DELIVERY OF PRODUCTS I'LL SHOW
IN THE NEXT SLAYED CALLED THE
OPPORTUNITY MAP.
NEXT SLIDE.
THE FOCUS WAS TO ADDRESS ALL
ORGAN SYSTEMS THAT AFFECT WOMEN
HEAD TO TOE ACROSS THE LIFE
COURSE INCLUDING UNDERSTANDING
THE DISEASES AND CONDITIONS THAT
OCCUR ONLY IN WOMEN ANDLY
MOST -- AND MOSTLY IN WOMEN AND
HAVE BROAD REPRESENTATION FROM
13 SECTORS AND MULTIPLE GENDERS
AND THE STRATEGY HERE IS THAT BY
INVESTING IN UNMET NEEDS THE
GOAL IS TO ACCELERATE INNOVATION
FOR WOMEN'S HEALTH AND
ULTIMATELY REDUCE MORBIDITY AND
MORTALITY AND INCREASE THE WELL
BEING OF WOMEN.
I DO WANT TO ACKNOWLEDGE JAMIE
WHITE, FORMER ORWH AND DR. MICA
THE FORMER CHAIRS AND HERE'S CHA
WHAT THEY DELIVERED.
THEY DELIVERED AN OPPORTUNITY
MAP LAYING OUT 50 EQUITABLE
HIGH-RETURN OPPORTUNITIES TO
ADDRESS GLOBAL INNOVATION FOR
WOMEN'S HEALTH.
THEY NEEDED TO ADDRESS NEW
MARKETS AND OPPORTUNITIES,
REDUCE MORBIDITY AND MORTALITY,
IMPROVE SOCIETAL OUTCOMES,
INCLUDE STRONGER ECONOMIES AND
LEADERSHIP WITH WOMEN'S HEALTH
AND WELL BEING AT THE CENTER.
YOU CAN SEE HERE WE USE THE
CRITERIA TO PRIORITIZE THE MANY
NEEDS AROUND THE WORLD.
THEY HAD TO HAVE POTENTIAL FOR
IMPACT AND NEEDED TO BE READY TO
MOVE FORWARD AND SUPPORT WOMEN
AND WE CALL THEM THE PRIME
CRITERIA.
WE USE THE LENSES AN THESE ARE
THE 10 SECTIONS OF THE REPORT TO
ADVANCE OPPORTUNITIES FOR
EQUITABLE INNOVATION.
THERE'S ALSO CROSS-CUTTING
TOPICS LISTED ON THE BOTTOM.
I'LL HIGHLIGHT IN MY NEXT SLIDE
A FEW OF THE OPPORTUNITIES IN
THE RESEARCH DESIGN AND
METHODOLOGY SPACE.
I WAS TO ADVANCE SEX AND GENDER
AND ANALYSIS IN ALL RESEARCH
STAGES TO PROMOTE KNOWLEDGE AND
RESOURCE SHARING IN THE
PRECLINICAL AND CLINICAL
RESEARCH LANDSCAPE, STRENGTHEN
THE USE OF COMPUTATION AND BIO
INFORMATICS AND DEEP LEARNING
APPROACHES AND TO SUPPORT IN
VITRO AND OTHER MODEL
DEVELOPMENT LIKE ORGANS ON A
CHIP AND OTHERS.
HERE'S KEY INTERESTED PARTIES
AND THIS MAPS THE FIRST STEP TO
GATHER THE INDIVIDUAL AND SECTOR
PARTNERS IN THE R&D ECO SYSTEM
AND COALESCE AROUND THE
POTENTIAL FOR IMPACTFUL
INVESTMENTS THAT ARE IMPORTANT
STEPS AND OPPORTUNITIES IT
NEEDED TO IMPROVE WOMEN'S
HEALTH.
IN ADDITION WE HAVE A SIGNATURE
PROGRAM IN PARTNERSHIP WITH THE
OFFICE OF AIDS AND PUT OUT AN
RFI LOOK FOR INPUT ON RESEARCH
OPPORTUNITIES AND RECEIVED INPUT
FROM A VARIETY OF INDIVIDUALS,
REMIND RESPONDENTS FROM
RESEARCH, COMMUNITY MEMBERS,
PROVIDERS, INDIVIDUALS WITH HIV
AND ORGANIZATIONS AND ADVOCACY
GROUPS.
THAT INFORMATION IS BEING
COLLATED TO NUMBER OUR NEXT
STEPS
AND I HOSTED A NIH WOMEN'S
WORKSHOP TO FOSTER
INTERDISCIPLINARY,
INTERSECTIONAL AND
COMMUNITY-CENTERED KNOWLEDGE
EXCHANGE ON TOPICS OF RELEVANCE
TO HIV AND CISGENDER AND GENDER
DIVERSE PEOPLE TO REVIEW THE
STATE OF SCIENCE TO HIGHLIGHT
MODIFIABLE FACTORS SO WE COULD
LOOK AT PREVENTION AND
DIAGNOSTIC TREATMENT AND CURE
FOR ALL WITH HIV AND IDENTIFY
OPPORTUNITIES TO ADVANCE
RESEARCH.
I'D LIKE TO GIVE AN UPDATE ON
THE OFFICE OF AUTO IMMUNE
DIVERSE RESEARCH IN FY23 WE
FUNDED 41 APPLICATIONS FROM 12
INSTITUTE, CENTER OR OFFICES AND
BROKEN DOWN AS LISTED HERE.
I WANT TO HIGHLIGHT A
PUBLIC-PRIVATE PARTNERSHIP
ACCELERATING MEDICINE'S
PARTNERSHIP ON AUTO IMMUNE OR
AMP AIM.
WE HAVE TWO SCIENTIFIC AWARDS
THERE AS WELL.
WE ALSO SUPPORTED 10 INTRAMURAL
RESEARCH PROGRAMS AND TRAINEES
AND I'LL HIGHLIGHT
AS WELL AS BE AN UPDATE ON MAY
AND ANALYZING AN UPDATE ON AUTO
IMMUNE DISEASE AND PUBLISHED AN
INTRODUCTION TO THE OFFICE OF
AUTO IMMUNE DISEASE RESEARCH
HIGHLIGHTING OUR FIRST YEAR OF
FUNDING.
I WANT TO ACKNOWLEDGE THE OADR
CORE THAT STOOD UP OADR IN THE
FIRST YEAR AS WE CAME INTO
HIRING THANK YOU TO THE MEMBERS
WHO TOOK UP THE MANTLE AND
STEPPED UP IN A VERY BIG WAY IN
ADDITION TO THEIR USUAL DUTIES.
I APPRECIATE ALL YOUR EFFORTS.
IT'S VERY EXCITING TO HAVE
DR. CRISWELL HERE TO SHARE WITH
YOU THIS PARTNERSHIP WITH NAIMS
ANNOUNCING THE AWARDEES AND
THESE ARE PLANNING GRANTS DESIGN
TO CREATE COLLABORATIONS AN
RESEARCH FRAME WORKS TO NFL THE
NETWORK WHICH WILL BE A NATIONAL
RESEARCH COLLABORATIVE APPROACH
THE NATIONAL INSTITUTE OF
ENVIRONMENTAL HEALTH SCIENCES IS
PLAYING A LEADERSHIP ROLE IN.
THE GOAL IS TO DEVELOP A
SYSTEMS-LEVEL APPROACH TO
UNDERSTANDING MECHANISMS RELATED
TO HOW EXPOSURES IN THE
ENVIRONMENT PERTURB CELLULAR
ORGAN AND TISSUE FUNCTION ACROSS
MULTIPLE AUTO IMMUNE DISEASES
AND I'M EXCITED TO SHARE THIS
INFORMATION WITH YOU AND LOOK
FORWARD TO HEARING FROM THEM IN
THE FUTURE.
AUTO IMMUNE DISEASES AND BASIC
SCIENCE AND UNDERSTANDING HAS
BEEN IN THE NEWS WITH NIH FUNDED
RESEARCH BEING HIGHLIGHTED IN
CELL RECENTLY AND POPULAR MEDIA
AS WELL.
IT OCCURS XIST CAN BIND WITH
PROTEINS AND ONLY HAPPENS IN
FEMALES AND YOU CAN SEE IT
DELINEATED HERE.
THIS IS AUTO ANTIGENIC IN ITSELF
AND PURPORTED TO PLAY A ROLE IN
WHY FEMALES HAVE MORE AUTO
IMMUNE DISEASE.
THIS WAS A REAL CLUE THAT NIH
BASIC SCIENCE HELPED UNCOVER
RELATED TO AUTO IMMUNE DISEASE
AND SEX DIFFERENCES.
AS I MENTIONED, DR. BERTAGNOLLI
FEATURED AUTO IMMUNE DISEASES IN
ONE OF HER BLOGS AND TALKED
ABOUT THE BASIC SCIENCE AND HOW
WE NEED TO MAKE SURE THOSE
INVESTMENTS IN BASIC SCIENCE TO
HELP US
-- FOR SUPPORTING CAREGIVERS
WORKING IN SCIENCE, ENGINEERING
AND MEDICINE WILL BE RELEASED.
ORWH HAS BEEN PLEASED TO SUPPORT
BOTH EFFORT.
IN ADDITION, WE HAVE ALSO
SUPPORTED RESEARCH ON ADDRESSING
SEXUAL HARASSMENT.
SEVERAL YEARS AGO THE THEN NIH
DIRECTOR DR. FRANCIS COLLINS
CREATED AN ADVISORY COMMITTEE TO
THE WORKING GROUP ON ENDING
SEXUAL HARASSMENT.
I WAS PRIVILEGED TO BE ON THAT
WORKING GROUP.
FOLLOWING THAT GROUP, NIGMS HAD
A FUNDING OPPORTUNITY ON
INTERVENTIONS INCLUDING
POTENTIAL STRATEGIES RELATED TO
SEXUAL HARASSMENT AND ORWH
HELPED FUND A GRANT ONGOING.
HERE'S ONE OF THE PUBLICATIONS
FROM ONE OF THOSE GRANTS AND WE
LOOK FORWARD TO FUTURE
PUBLICATIONS.
THE NATIONAL ACADEMIES HAS AN
ACTION COLLABORATIVE WITH
MULTIPLE ORGANIZATIONS
COALESCING AROUND THE NEED TO
PREVENT SEXUAL HARASSMENT AND
OUR ASSOCIATE DIRECTOR OF
CAREERS HERE IN THE AUDIENCE
PARTICIPATED ON AN ACTION
COLLABORATIVE ON TRANSFORMING
TRAJECTORIES FOR WOMEN OF COLOR
IN TECH.
THIS IS LOOKING MORE TOWARDS THE
TARGETED COLLECTIVE ACTION
GUIDED BY AN INTERSECTIONAL
APPROACH AND THERE'S A LARGE
NUMBER OF ACTIVITIES.
FURTHER LATER THIS WEEK, THE
COMMITTEE ON THE ADVANCEMENT
OF -- ASSESSMENT OF NIH WOMEN'S
HEALTH ONGOING IS HAVING A
PUBLIC MEETING SOLICITING INPUT
AND DR. TARA SCHWETZ WILL BE
PRESENTING THERE THURSDAY.
LASTLY, AT THE END OF APRIL, A
WORKSHOP WILL BE HELD WITH
NATIONAL INSTITUTE OF MENTAL
HEALTH INVOLVEMENT ON ESSENTIAL
HEALTH CARE SERVICES RELATED TO
ANXIETY AND MOOD DISORDERS IN
WOMEN.
A LOT OF ACTION THERE.
YOU'VE HEARD HERE ABOUT THE
PATHWAYS TO PREVENTION PROGRAM
IN THE PAST AND I'M EXCITED TO
SHARE WITH YOU THAT IN ADDITION
TO THE INDEPENDENT PANEL REPORT,
THE INDEPENDENT PANEL SUMMARY,
AND SYSTEMATIC EVIDENCE REVIEW
AND MAP ON SOCIAL AND STRUCTURAL
DETERMINATES FOR MATERNAL
MORBIDITY, AND MORTALITY THE
FEDERAL PARTNERS REPORT WAS
RECENTLY ADDRESSED.
ALL THESE DELIVERABLES ARE
AVAILABLE ON THE OFFICE OF
DISEASE PREVENTION WEBSITE FOR
THE PATHWAYS TO PREVENTION
PROGRAM.
SO WE ARE SEEING IN THOSE
DELIVERABLES A CALL FOR A
MATERNAL HEALTH MOONSHOT TO
ADDRESS MATERNAL MORBIDITY AND
MORTALITY IN THIS COUNTRY IN
WAYS THAT WILL MOVE THE NEEDLE
AND REDUCE MATERNAL MORTALITY.
EXCITING NEWS OF THE OFFICE OF
DISEASE PREVENTION.
ON A PATHWAYS TO PREVENTION
WORKSHOP ON THE MANAGEMENT OF
MENOPAUSE SYMPTOMS.
AS WE KNOW MENOPAUSE IS A NORMAL
PHASE OF LIFE BUT THE EXPERIENCE
CAN BE DIFFERENT FOR EVERYONE
AND CAN AFFECT QUALITY OF LIFE
AND THE DYNAMIC TRANSITION
SOMETHING WE NEED TO UNDERSTAND
BETTER IN SIGNALLING THE RISK
FOR CHRONIC DISEASE AND FOR
OTHER REASONS BUT MENOPAUSE WAS
SELECTED AS THE NEXT PATHWAYS TO
PROGRAMS AND THIS IS AN
IMPORTANT NEXT STEP IN
IDENTIFYING GAPS IN MENOPAUSE
RESEARCH.
WE'RE EXCITED TO BE PARTNERING
WITH MULTIPLE INSTITUTES AND
CENTERS ON THE EFFORT AND LOOK
FORWARD TO THAT WORKSHOP.
YOU MAY RECALL LAST YEAR THE
VIVIAN SYMPOSIUM LOOKED AT THIS
AND THE LEAD WAS ASSOCIATE
DIRECTOR FOR CLINICAL WRRCH.
AND TODAY YOU'LL HAVE A SPECIAL
PANEL CHAIRED BY DR. DUDA AND
HEAR FROM OTHERS ON THIS
IMPORTANT TOPIC.
CAN'T WAIT TO HEAR FROM THEM AND
DURING NATIONAL WOMEN'S HEALTH
WEEK WE'LL BE HOSTING OUR FIRST
EVER HHS ROUNDTABLE AN FUTURE
GOALS OF OPTIMIZING HEALTH IN
WOMEN AND THE CENTERS ON SEX
DIFFERENCES REPRESENTS NIH'S
ONLY CENTER LEVEL SEX
DIFFERENCES DISEASE AGNOSTIC
FUNDING OPPORTUNITY.
WE PARTNER WITH MULTIPLE
INSTITUTES AND CENTERS AS LETS
-- LISTED HERE ADDRESSING VERY
IMPORTANT TOPICS IN SPECIFIC
WAYS.
I WANT TO HIGHLIGHT OUR MOST
RECENTLY ADDED SCORE WHICH IS AT
AUGUSTA UNIVERSITY.
RURAL OBESE AND AT RISK IS THE
NAME OF THE PROGRAM AND HAS
MULTIPLE COMPONENTS SPANNING
THREE UNIVERSITIES, FOUR AUGUSTA
UNIVERSITY COLLEGES AND 10
DEPARTMENTS.
THE TOPICS THEY'RE ADDRESSING
ARE TIMELY.
THEY'RE ADDRESSING WOMEN WITH
AUTO IMMUNE DISEASE AND LOOKING
AT MECHANISMS THAT DRIVE
SUSCEPTIBILITY IN FEMALES VERSUS
MALES AND LOOKING AT HIGH BLOOD
PRESSURE AND THE AFFECT OF
LECTIN AN FEMALES WITH LUPUS AND
LOOKING AT INNATE CHANGES IN
RENAL FUNCTION IN WOMEN WITH
AUTO IMMUNE DISEASE.
THIS REPRESENTS THE STRATEGIES
OF THE SPECIALIZED CENTERS OF
EXCELLENCE ON SEX DIFFERENCES
WITH A REAL POWER TO ADDRESS THE
HEALTH OF WOMEN IN DEFINITIVE
WAYS THAT INCORPORATE SEX
DIFFERENCES AS WELL AS A FOCUS
ON THE HEALTH OF WOMEN.
IN TERM OF SEX AND GENDER
UPYOU'RE AWARE OF THE SEX AND
GENDER EQUITY AND RESEARCH
GUIDELINES AND WE HOSTED THE NIH
SEX AND GENDER DISEASE INTEREST
GROUP SEVERAL MONTHS AGO.
THAT EFFORT IS LED BY DR. HUNTER
OUR ASSOCIATE DIRECTOR FOR BASIC
AND TRANSLATIONAL RESEARCH AND
WE HAVE MULTIPLE SPEAKERS TALK
ON SEX AS A BIOLOGICAL VARIABLE
AND SEX-INCLUSIVE APPROACHES AND
JOINED BY A FORMER ADVISORY
COMMITTEE MEMBER AND HONORED BY
THE PRECISION MEDICINE WORLD
CONFERENCE EARLIER THIS YEAR
WITH AN INFECTION ON SEX AND
GENDER.
THE WORLD HEALTH ORGANIZATION
HAS ANNOUNCED ADOPTION OF THE
SEX AND GENDER EQUITY IN
RESEARCH GUIDELINES.
THEY ARE NOW PUTTING FORWARD
REPORTS THAT ARE DISAGGREGATED
BY SEX AND/OR GENDER AS
APPROPRIATE AND ON THIS WEBINAR
I WAS JOINED BY DR. CHEN FROM
THE GATES FOUNDATION AND OTHERS
AND THIS WAS HOSTED BY
DR. RICHARD HORTON OF THE LANCET
WHERE WE TALKED ABOUT HOW
IMPORTANT IT IS TO HAVE AN
ORGANIZATION LIKE W.H.O.
ADOPTING THE GUIDELINES TO
SUPPORT DISIMMIGRATION OF DATA
BY SEX AND GENDER AND
INCORPORATING INTO THEIR
OPERATING PRINCIPLES.
IN COLLABORATION WITH THE
NATIONAL CANCER INSTITUTE, THERE
ARE AN NIH SEX AND GENDER
DIFFERENCES CANCER WORK CHOMPS
NOW ORGANIZED.
THE NEXT IS ON CLINICAL SCIENCES
YOU CAN SEE HERE THEY INCLUDE A
KEY NOTE AS WELL AS RESEARCH
TALKS AND PANEL DISCUSSIONS.
DO JOIN US FOR THAT.
AND AS I MOVE INTO THE LAST
SECTION, OF THE PRESENTATION I
WANT TO HIGHLIGHT THE ORWH
BUDGET HISTORY.
I PROVIDE THIS FOR YOU EACH YEAR
AND DO SEE GOOD NEWS HERE.
IT'S BEEN A LITTLE FLAT FOR SOME
TIME THERE WITH NO CHANGE IN OUR
OVER ALL FUNDING AND IN FACT
THAT WOULD REPRESENT A DECREASE
IN OUR FUNDING BECAUSE OF
DECREASED BUYING POWER DUE TO
INFLATION HOWEVER, IN FY23 THE
CONSOLIDATIONS APPROPRIATIONS
ACT PROVIDED AN ADDITIONAL $10
MILLION TO CREATE THE OFFICE OF
AUTO IMMUNE DISEASE RESEARCH.
SO WE ARE EXCITED ABOUT THAT AND
YOU CAN SEE ON THE RIGHT ON THE
PIE CHART THE BREAKDOWN OF OUR
EXTRAMURAL RESEARCH FUNDING IN
TERMS OF PROGRAMS.
THIS SLIDE HIGHLIGHTS JUST THE
CAREER PROGRAMS.
WE DO LEAD A VARIETY OF THEM AND
I'LL TALK ABOUT THEM IN A
MOMENT.
THESE ARE THE -- THIS IS THE
BREAKDOWN OF ORWH FUNDING GOING
TO CO-FUNDING AND SEE THE BIRCWH
PROGRAM AND THE TOP INSTITUTES
IN TERMS OF GETTING GREATER
AMOUNTS OF ORWH FUNDING ALIGNED
WITH MISSIONARIES AND THE AGING
INSTITUTE AND NHLBI AND IF YOU
REMOVE THE BIRCWH PROGRAM YOU
SEE OTHERS AND THE GROUP IN THE
MIDDLE AND THEN THIS GROUP HERE
LOWER.
HERE'S THE SIGNATURE PROGRAMS
AND EXTRAMURAL INVESTMENTS WITH
OUR PARTNERS.
ON THE RIGHT, OUR INVESTMENTS
HERE AND THE NUMBER OF
CO-FUNDING I.C.s AND NUMBER OF
PARTNERS.
I'M NOT GOING TO LIST THEM BUT
YOU SEE A WIDE VARIETY OF
INSTITUTES AND CENTERS
SUPPORTING ORWH SIGNATURE
PROGRAMS THAT REPRESENT
COMPLEMENTARY PROGRAMS LEADING
TO THEIR EFFORTS AND WE CAN TALK
ABOUT THOSE IN MORE DETAIL
DURING THE DISCUSSION.
IN TERMS OF CAREER ADVANCEMENTS,
WE CREATED A TEAM-SCIENCE
LEADERSHIP SCHOLAR PROGRAM IN
WOMEN'S HEALTH AUTO IMMUNE AND
IMMUNE-MEDIATED DISEASE WITH
NIAMS AND DATA SCIENCE STRATEGY
AND AWARDED THE FIRST LSP
GRANTEES, ONE OF WHICH WAS A
FORMER BIRWCH SCHOLAR THAT
SUPPORTS IN THIS TOPIC AREA TO
BE IN A POSITION TO LEAD LARGE
CONE CORE SHA AND IT'S BEEN --
CONSORTIA AND IT'S BEEN A
PRIVILEGE TO WORK WITH
DR. CRISWELL AND HER TEAM ON THE
PROGRAM.
THE MOST RECENT FUNDING
OPPORTUNITY WE HAD A SECOND ONE
JUST CLOSED SO STAY TUNED FOR
MORE NEWS ON THAT.
WE ALSO WERE EXCITED TO BE ABLE
TO SHARE SOME
HIGHLIGHT SUCCESSFUL STRATEGIES
AND FOR PEOPLE TO LOOK AT
METHODOLOGIES OR STRATEGIES THAT
MIGHT WORK IN THEIR
ORGANIZATION.
WE'RE SUPPORTING JUNIOR AND
EARLY STAGE CAREER INVESTIGATORS
THROUGH TRAVEL AWARDS AT THE
ORGANIZATION FOR THE STUDY OF
SEX DIFFERENCES.
OUR FIRST TRAVEL AWARDEE HERE
AND CREATED A NEW TRAVEL WARD
FOR THE MENOPAUSE SOCIETY TI
MEET AND LOOK FORWARD TO
ANNOUNCE TWO JUNIOR
INVESTIGATORS TO ATTEND THE
MEETING.
AND ROUNDI IING CLEARS.
IT WAS DELIGHTFUL TO BE AT THE
INTERNATIONAL WOMEN'S CONFERENCE
AND THEIR THEME WAS INQUIRY AND
INTERVENTION THROUGH SCHOLARSHIP
AND RESEARCH AND I WAS DELIGHT
TO BE THERE TO BE ABLE TO SHARE
ORWH'S STORY AND A LITTLE BIT
ABOUT MY CAREER.
UPCOMING EVENTS, I HOPE THAT YOU
ALL HAVE ON YOUR CALENDAR THE
EIGHTH ANNUAL VIVIAN PIN
SYMPOSIUM AND HONORS THE FIRST
FULL-TIME DIRECTOR SH, VIVIAN P
SO JOIN US.
THIS IS ALL VIRTUAL ENTITLED
SYNERGY IN SCIENCE AND
INNOVATIONS IN AUTO IMMUNE
DISEASE RESEARCH AND CARE AND
REPRESENTS NIH'S OBSERVANCE OF
NATIONAL WOMEN'S HEALTH WEEK AND
WE HAVE A VARIETY OF SPECIAL
ACTIVITIES PLANNED FOR YOU THAT
WEEK.
STAY TUNED FOR SPECIAL EVENTS
AND ANNOUNCEMENTS.
I MENTIONED MOST ALREADY SO I'LL
MOVE FORWARD AND ROUND OUT THE
PRESENTATION TWO MINUTES EARLY.
IT'S SO IMPORTANT THAT WE SHARE
THIS INFORMATION WITH YOU AS OUR
ADVISORY COMMITTEE MEMBERS.
YOUR RESPONSIBILITY AND ROLE IS
CRITICAL TO OUR EFFORTS AS WE
WORK ACROSS NIH WITH ALL THE
INSTITUTES AND CENTERS TRYING TO
PROVIDE SCIENTIFIC SYNERGY AND
ALSO TO BE COMPLIMENTARY TO
THEIR EFFORTS TO ADVANCE THE
HEALTH OF WOMEN.
AS YOU KNOW WE CONSIDER WOMEN'S
HEALTH EVERYTHING THAT AFFECTS A
WOMAN FROM HEAD TO TOE INSIDE
AND OUT ACROSS THE LIFE COURSE
CONNECTING THE DOTS IS CRITICAL
AND WE FEEL PRIVILEGED TO BE
ABLE TO BE ABLE TO WORK ON THAT
WITH YOU.
SO THANK YOU SO MUCH FOR YOUR
ATTENTION.
I'M GOING COME BACK TO THE TABLE
AND WE CAN DO QUESTIONS AND
ANSWERS FROM THERE.
THANK YOU.
>> THERE'S TIME FOR ONE OR TWO
QUESTIONS FOR DR. CLAYTON.
THERE'S OTHER TIME IN THE FOR
DISCUSSION TIME.
>> STEVE HIGGINS.
I WAS CURIOUS ABOUT THE
AVAILABILITY OF THE SLIDES TO
US.
OKAY.
>> I DON'T HAVE A QUESTION BUT
COMMENT WANT TO EXPRESS AS AN
NIH DIRECTOR HOW GRATEFUL WE ARE
FOR DR. CLAYTON FOR EVERYTHING
SHE'S DOING RELATED TO WOMEN'S
HEALTH.
A LOT HAS BEEN ASKED OF HER
RECENTLY AND SHE'S DELIVERED SO
BEAUTIFULLY AND ON TIME AND IT'S
BEEN A VERY HEAVY LIFT AND
YOU'VE DONE A FANTASTIC JOB.
WE'RE GRATEFUL TO YOU FOR ALL
YOU'RE DOING.
>> THANK YOU.
I'LL BE OUR TIME KEEPER AND
WE'LL MOVE ON.
THANK YOU, DR. CLAYTON.
I WOULD NOW LIKE TO WELCOME OUR
HEALTH SCIENCE POLICY ANALYST AT
ORWH TO INTRODUCE THE NEXT
SPEAKER.
WELCOME.
>> GOOD MORNING.
IT'S MY PLEASURE TO INTRODUCE
DAWN CORBETT THE NIH INCLUSION
POLICY OFFICER IN THE OFFICE OF
EXTRAMURAL ACTIVITIES WHERE SHE
PROVIDES A LEADERSHIP AND
COORDINATION TO IMPLEMENT
NIH-WIDE EFFORTS TO ENSURE
INCLUSION OF WOMEN, MEMBERS OF
RACIAL AND ETHNIC MINORITIES AND
INDIVIDUALS ACROSS THE LIFE SPAN
IN NIH DEFINED CLINICAL
RESEARCH.
PRIOR TO JOINING OER IN 2017,
SHE HELD POSITIONS AT THE
NATIONAL INSTITUTE OF MENTAL
HEALTH FOR 14 YEARS WHERE SHE
OVERSAW PROGRAM ACTIVITY TO
INCREASE DIVERSITY, EFFICIENCY
AND TRANSPARENCY IN MENTAL
HEALTH CLINICAL RESEARCH
PORTFOLIO.
SHE HAS A MASTER'S DEGREE IN
PUBLIC HEALTH FROM THE JOHNS
HOPKINS BLOOMBERG SCHOOL OF
PUBLIC HEALTH AND BACHELOR'S
DEGREE IN POLITICAL SCIENCE FROM
THE UNIVERSITY OF ILLINOIS
CHAMPAGNE.
WELCOME, DAWN.
>> THANK YOU VERY MUCH.
I'M DELIGHTED TO BE HERE AGAIN
AND I WANT TO TALK TO YOU ABOUT
SOME OF THE THINGS WE'RE DOING
ON INCLUSION AT NIH RESEARCH.
JUST TO GET STARTED, I JUST WANT
TO TAKE A MOMENT TO REVIEW OUR
INCLUSION POLICY.
THIS IS SOMETHING I LIKE TO DO
WITH YOU EVERY YEAR.
AS A REMINDER OF THE POLICIES
THAT WE HAVE HERE AT NIH.
AND THE PURPOSE OF OUR INCLUSION
POLICIES IS IT ENSURE OR
RESEARCH IS GENERALIZABLE AND
THE PEOPLE AFFECT THE CONDITION
BENEFIT FROM THE RESEARCH WE DO
HERE.
SO WE HAVE TWO MAIN INCLAUUSION
POLICIES ON THE INCLUSION OF
RACIAL AND ETHNIC MINORITY GROUP
AND THEY MUST BE INCLUDED IN ALL
NIH-FUNDED CLINICAL RESEARCH
STUDIES[NO AUDIO]
[NO AUDIO]
FOR A SUBSET OF PHASE III
CLINICAL TRIALS THEY'RE
FDA-REGULATED PRODUCTS AND HAVE
TO REPORT THE RESULTS OF THEIR
ANALYSES BY SEX OR GENDER, RACE
AND ETHNICITY IN
CLINICALTRIALS.gov.
OUR OTHER INCLUSION POLICY IS A
BIT MORE RECENT, OUR INCLUSION
ACROSS THE LIFE SPAN REPLACING
THE CHILDREN INCLUSION POLICY
AND DUE DATES JANUARY 25, 2019
OR LATER.
THIS POLICY REQUIRES INDIVIDUALS
OF ALL AGES BE INCLUDED IN NIH
HUMAN SUBJECTS RESEARCH UNLESS
THERE'S SCIENTIFIC OR ETHICAL
REASONS NOT TO DO SO.
LIKE OTHER INCLUSION POLICY, WE
REQUIRE INCLUSION BE APPROPRIATE
TO THE SCIENCE AND THAT THERE'S
A SCIENTIFIC OR ETHICAL REASON
IF ANY GROUPS ARE EXCLUDED FROM
OUR RESEARCH.
POLICY ALSO REQUIRES PARTICIPANT
DATA AND PROGRESS REPORT.
IF IN THE PAST YOU SUBMIT THE
INCLUSION TABLES WITH THE NIH
GRANT IT'S BEEN REPLACED BY A
SPREAD SHEET OR CSV FILE WHERE
THE PROVIDE THE SEX, GENDER,
RACE, ETHNICITY OR AGE OF EACH
PARTICIPANT IN THE RESEARCH.
AND WE REPORT THE DATA EVERY
YEAR WE REPORT THOSE IN THE
REPORT WE'LL START MAKING OUR
DATA BY RCDC CATEGORY AVAILABLE
ANNUALLY.
WE STARTED PROVIDING INCLUSION
DATA BY RCDC RESPONSE TO THE
21st CENTURY CURES ACT.
WE HAVE PROVIDED THEM EVERY
THREE YEARS BUT NOW WILL PROVIDE
THOSE EVERY YEAR.
STAY TUNED FOR THE NIH REPORT
SITE AND WE'LL SEE THE 2023 DATA
I'M SHARING WITH YOU TODAY THERE
IN THE NEXT FEW WEEKS.
MY OFFICE ALSO WORKS ON A NUMBER
RESOURCES RELATED TO
PARTICIPANT INCLUSION AND
INCLUDE CHILDCARE AND MEALS FOR
PARTICIPANTS.
REIMBURSEMENT FOR TRAVEL AND
THESE KINDS OF THINGS.
NOT EVERYONE IS AWARE OF WHAT
NIH CAN PAY FOR AND LAUNCHED LA.
THIS PROJECT WAS LOOKING AT
ORGANIZATIONAL STRATEGIES TO
IMPROVE INCLUSION IN CLINICAL
RESEARCH.
AND SO AS PART OF THE LAUNCH OF
THIS PROJECT, IT INCLUDED A
NUMBER OF RECOMMENDATIONS FOR
ORGANIZATIONS TO HELP THEM
IMPROVE INCLUSION ALONG WITH THE
MATURITY MODEL PROVIDING
GUIDANCE FROM INSTITUTIONS THAT
DO RESEARCH.
EVERYTHING FROM LARGE ACADEMIC
INSTITUTIONS TO INDUSTRY TO
COMMUNITY-BASED ORGANIZATIONS.
AND THE STEPS THEY CAN TAKE TO
IMPROVE THE INFRASTRUCTURE FOR
INCLUSION AT THEIR INSTITUTION.
AND THESE INCLUDE FOUR THEMES
INCLUDING A DEMONSTRATED
COMMITMENT FROM LEADERSHIP AND
INCLUSION AT THE INSTITUTION,
BI-DIRECTIONAL COMMUNITY
PARTNERSHIP AND ENGAGEMENT WITH
PATIENT AND COMMUNITY GROUPS AND
RESOURCES INCLUDING DEDICATED
PERSONNEL AND INVESTMENTS.
-- PROVIDE FLEXIBILITY TO HELP
ORGANIZATIONS DO THAT.
THAT'S AVAILABLE ON THE CTTI
WEBSITE.
WE'RE PLEASED TO BE A PART OF
THAT PROJECT WORKING WITH
COLLEAGUES AT AND ACADEMIA,
INDUSTRY AND ELSEWHERE.
WITH THAT QUICK OVERVIEW OF SOME
HIGHLIGHTS OF WHAT WE'VE BEEN
DOING IN THE INCLUSION WORLD IN
THE LAST YEAR I WANT TO SHARE
OUR FISCAL YEAR 2023 INCLUSION
DATA.
SO BEFORE I DIVE INTO THE
PROPORTIONS, I JUST WANT TO GIVE
YOU AN IDEA MUCH THE SCOPE OF
THE DATA THAT YOU'RE LOOKING AT.
I WON'T GO OVER ALL THE NUMBERS
BUT I'LL SHARE IS THIS SLIDE
REPRESENT THE NUMBER OF
INCLUSION ENROLLMENT REPORTS FOR
OUR CLINICAL RESEARCH STUDIES
AND OUR PHASE 3 CLINICAL
RESEARCH STUDIES.
SO EVERY STUDY SUBMITS AN
INCLUSION ENROLLMENT REPORT AND
HAS INCREASED A BIT SINCE 2021.
WE HAD ABOUT 26,000 STUDIES
INCLUDE IN 2021.
THAT'S JUMPED TO ABOUT 28,000.
THE DATA THAT HAVE STARTED
ENROLLING PARTICIPANTS.
SO WE HAVE SEEN AN INCREASE IN
THE NUMBER OF STUDIES THAT HAVE
ENROLLED PARTICIPANTS IN
RESEARCH NOW THAT FOLKS ARE UP
AND RUN ARING WITH ENROLLMENT.
WE HAVE ABOUT 16,500 STUDIES
REPORTED HERE.
AND A TREND IN RESEARCH IS MOST
ARE U.S. SITES AND HAVE A SMALL
PROPORTIONATE NON-U.S. SITES AND
HAVE MORE FEMALE ONLY THAN MALE
ONLY STUDIES.
YOU SEE IN THE RECENT FISCAL
YEAR ONLY 750 MALE ONLY STUDIES.
AND THEY INCLUDE ALL SEXES OR
GENDERS.
WHEN WE LOOK AT THE PHASE III
COLLABORATES IT'S A SMALLER
UNIVERSE THAN THE NIH CLINICAL
RESEARCH.
OPPOSED TO THE 28,000 THAT WE
HAD IN CLINICAL RESEARCH ARE IN
2023, THEY HAD ABOUT 1200 NIH WE
HAVE 800 TRIALS.
WE HAVE ABOUT 176.
AND SOME REPORTED ONLY FEMALES
OPPOSED TO 40 INCLUDING ONLY
MALES.
THIS SLIDE SHOWS THE NUMBER OF
PARTICIPANTS THAT WE'RE LOOKING
AT IN THE DATA.
I PROVIDED THREE YEARS HERE FOR
COMPARISON BUT WE'LL FOCUS ON
THE 2023 DATA.
SO OUR TOTAL ENROLL MANY THIS
YEAR IS PRETTY TYPICAL.
WE HAVE ABOUT 12 MILLION
PARTICIPANTS IN OUR RESEARCH.
ABOUT MILLION ARE
U.S. PARTICIPANTS OR ABOUT
THREE-QUARTERS OF THOSE AND A
QUARTER OF THE PARTICIPANTS ARE
FROM OUTSIDE THE U.S. WHEN WE'RE
LOOKING AT OUR CLINICAL
RESEARCH.
LOOKING AT PHASE III CLINICAL
TRIALS THE NUMBERS ARE DIFFERENT
ABOUT 800,000 PATIENTS IN OUR
PHASE III CLINICAL TRIALS IN
FISCAL YEAR 2023.
WE HAVE FEWER U.S.-ONLY
PARTICIPANTS WHEN WE'RE LOOKING
AT A PROPORTION OF 62% IN THE
U.S. AND 38% ARE NON-U.S.
AND RESEARCH ENROLLMENT BY SEX
OR GENDER FOR FISCAL YEARS 2022
AND 2023 AND THEY'RE ADJUSTED
BECAUSE OF ONE STUDY WITH 86
MILLION PARTICIPANTS AND WE
EXCLUDED THAT HERE.
THE TRENDS BY SEX OR GENDER HAVE
BEEN FAIRLY STUDY OVER A NUMBER
OF YEARS.
I'VE BEEN DOING THIS ABOUT 20
YEARS AND IN MOST OF THOSE YEARS
WE SEE MORE FEMALE PARTICIPANTS
THAN MALE PARTICIPANTS.
THAT STILL HOLDS TRUE.
AND THERE WERE 26% IN 2022 AND
AGAIN 56.5% IN 2023.
WHEN WE LOOK AT ENROLLMENT IN
PHASE III CLINICAL TRIALS WE SEE
A GREATER PROPORTION OF WOMEN IN
PHASE III CLINICAL TRIALS THAN
RESEARCH AS A WHOLE.
WE HAVE MORE FEMALE ONLY NIH
PHASE III TRIALS AND EXPLAINS
THE DIFFERENCE.
WE'RE UP TO IN 2023 TWO-THIRDS
OF PARTICIPANTS IN OUR CLINICAL
TRIALS IDENTIFIED AS FEMALE.
THAT'S UP FROM 61% IN FISCAL
YEAR '21.
IF WE LOOK AT DATA BY RACE IT'S
BEEN TRENDS WITH NOTABLE
EXCEPTIONS.
THE LARGEST RACIAL GROUP
REPORTED IS WHITE WHICH HAS BEEN
CONSISTENT OVER THE YEARS THOUGH
THE NUMBER HAS DECREASED.
IT'S ABOUT 53% IN 2021 INCREASE
TO 58% IN 2022 AFTER WE ADJUSTED
THE DATA AND NOW 46% OF
PARTICIPANTS.
IDENTIFIED BY WHITE.
THE LARGEST GROUP IS BLACK OR
AFRICAN AMERICAN.
THAT HAS RANGED FROM 18% TO 19%
IN 2023 NOW ABOUT 19% OF
PARTICIPANTS IDENTIFIED AS BLACK
OR AFRICAN AMERICAN AND THE NEXT
GROUP IS ASIAN ABOUT 12% IN 2021
DECREASED LAST YEAR AND BACK UP
TO 11% IN 2023.
WE HAVE PARTICIPATION FROM
OTHERS DECREASED A BIT IN FISCAL
YEAR 2023.
MORE THAN ONE RACE HAS HELD
FAIRLY STEADY BETWEEN 2% AND 3%
NOW AT 2.6%.
ANOTHER CHANGE WE'VE SEEN ACROSS
THE BOARD IN OUR DATA IS
INCREASE IN UNKNOWN OR NOT
REPORTED.
YOU CAN SEE THERE IN THE TOP
BLUE SECTION ABOUT 18% OF OUR
PARTICIPANTS DID NOT IDENTIFY A
RACE AND SO YOU MAY HAVE HEARD
OMB RECENTLY ANNOUNCED NEW
ETHNIC AND RACIAL CATEGORIES ON
MARCH 28 WHICH NIH WILL BE
IMPLEMENTING OVER THE NEXT
SEVERAL YEARS.
WE'LL SEE HOW IT AFFECTS
NOT-REPORTED INDIVIDUALS IN
STUDIES INVOLVING E.H.R.s.
WHEN WE LOOK AT THE NIH DEFINED
PHASE III CLINICAL TRIAL WE SIGH
A SMALLER PERCENTAGE OF UNKNOWNS
AND WE'RE LOOKING AT A SMALLER
SET OF STUDIES SO DATA JUMPS.
THE LARGEST RACIAL CATEGORY WAS
WHITE, 50.5% IN FISCAL YEAR
2023.
SO THAT'S DOWN A BIT FROM
PREVIOUS YEARS.
THE NEXT LARGEST RACIAL GROUP
WAS BLACK OR AFRICAN AMERICAN.
ABOUT A QUARTER OF PARTICIPANTS
NOW IDENTIFY AS BLACK OR AFRICAN
AMERICAN AS OF FISCAL YEAR 2023.
THAT IS FOLLOWED BY ASIAN AND
12% OF PARTICIPANTS IDENTIFIED
AS ASIAN IN 2023 AND THAT'S
FLUCTUATED FROM 18% IN 2021 TO
7% NOW BACK UP TO 12%.
SMALLER RACIAL GROUPS INCLUDE
AMERICAN INDIAN OR ALASKAN
NATIVE INCREASED FROM 1.1%.
NATIVE HAWAIIAN AND OTHER
PACIFIC ISLANDER DECREASED FROM
.2% TO .1% AND NOT REPORTED IS
SMALLER THAN OUR OVER ALL
CLINICAL RESEARCH ABOUT 9% OF
PARTICIPANTS WERE UNKNOWN OR NOT
REPORTED.
LOOKING AT ETHNICITY, THE
NUMBERS HAVE INCREASED A BIT FOR
HISPANIC OR LATINO PARTICIPANTS
SINCE 2021, 10% UP TO 12% IN
FISCAL 2023.
WE ALSO HAVE SEEN AN INCREASE IN
THE PROPORTION OF UNREPORTED
ABOUT 10% ALSO IN 2021 NOW UP TO
14% IN 2023.
AND AGAIN WE LOOK FORWARD TO
SEEING HOW THE CHANGES IN OMB
CATEGORIES MAY AFFECT THE
NUMBERS.
LOOKING AT NIH DEFINED PHASE III
CLINICAL TRIALS THE NUMBERS JUMP
AROUND A BIT AND THIS IS LARGELY
DUE TO ONE STUDY NOT REPORTED IN
2022.
SO THE 2022 DATA LOOK MORE
TYPICAL.
YOU SEE A CHANGE FROM 31% TO 15%
IN 2022 AND THAT'S BUMPED UP TO
16% IN FISCAL 2023.
I MENTIONED OUR INCLUSION ACROSS
THE LIFE SPAN POLICY IS PART OF
THE REQUIREMENT WE BEGAN
REQUIRING AGE AT ENROLLMENT.
THIS IS A SUBSET OF OUR DATA
NOW.
NOT ALL OUR STUDIES ARE ACROSS
THE LIFE SPAN BUT CERTAINLY MORE
ARE NOW.
WE CAN NOW LOOK AT THE AGE OF
OUR PARTICIPANTS BY AGE GROUP.
SO THIS SLIDE SHOWS SOME OF AGE
GROUPS OF CHILDREN ADULTS AND
OLDER ADULTS AND UNKNOWN OR NOT
REPORTED.
NO SURPRISE,
ABOUT 20% DOWN TO ABOUT 9%.
AGAIN, WE'LL LOOK FORWARD TO
SEEING WHAT THE TRENDS LOOK LIKE
OVER TIME.
OLDER ADULTS FS FLUC SHUATED AN
LOOKED AT THE DEVELOPING THE
POLICY AND WE HAVE A SMALLER
NUMBER OF PARTICIPANTS IN OUR
MIDDLE AGE GROUPS GETTING TO THE
UPPER AGE OF THE LIFE SPAN WHEN
WE LOOK AT INDIVIDUALS OVER 80.
SO WITH THAT I THINK WE HAVE A
FEW MINUTES IF THERE ARE ANY
QUESTIONS.
I WOULD BE HAPPY TO ADDRESS
THEM.
>> THANK YOU VERY MUCH, MS.
CORBETT.
NOW THE FLOOR'S OPEN FOR
QUESTIONS AND COMMENTS.
DR. SIMON.
>> THANK YOU FOR THAT REPORT.
EXCELLENT WORK.
SO WITH RESPECT TO ALLOWING
STUDIES TO DECLARE GENDER OR SEX
AND YOU PUT THEM ALL TOGETHER IF
THERE'S GOING TO BE SOME MOVE
TOWARDS SEPARATING THOSE TWO
QUESTIONS LIKE WHAT IS THE SEX
OF YOUR PARTICIPANTS AND WHAT
ARE THE GENDER IDENTITIES OF
YOUR PARTICIPANTS.
>> THANK YOU FOR ASKING THAT
QUESTION.
JUST TO CLARIFY FOR FOLKS IN THE
ROOM WHO MAY NOT BE AWARE, THE
POLICY DOES ALLOW INVESTIGATORS
TO REPORT EITHER SEX OR GENDER
DEPENDING ON WHAT'S MOST
RELEVANT TO THE SCIENTIFIC
QUESTION.
WE DO CURRENTLY PUT THOSE
TOGETHER INTO ONE CATEGORY AND
THAT'S CERTAINLY SOMETHING
THAT'S BEEN UNDER DISCUSSION AT
NIH.
WE RECOGNIZE THE DIFFERENCE
BETWEEN SEX AND GENDER, OUR
UNDERSTANDING HAS EVOLVES SINCE
THE POLICY WAS CREATED IN 1994
AND WE CERTAINLY WANT TO
UNDERSTAND IF STUDIES ARE
LOOKING AT SEX OR GENDER.
THAT'S SOMETHING THAT'S
CURRENTLY UNDER DISCUSSION.
>> ANDREA JONES.
WONDERING IF YOU WANTED TO SAY
MORE ABOUT THE INSTITUTES DOING
INCREDIBLY WELL WITH BEING ABLE
TO RECRUIT AND RETAIN
PARTICIPANTS AND HOW THEY'RE
SHARING THEIR DATA ANY SUCCESS
STORIES.
>> ABSOLUTELY.
WE HAVE SO MANY GROUPS DOING
WELL.
ONE YOU MAY HAVE HEARD ABOUT IS
SEAL OR COMMUNITY ENGAGEMENT
ALLIANCE STARTED IN THE COVID-19
PANDEMIC AND NOW CONTINUING
BEYOND THAT.
THEY'VE DONE A LOT OF OUTREACH
WITH COMMUNITIES.
THEY'VE DONE WEBINARS, RADIO, A
LOT OF OUTREACH AND THAT
CONTINUES AND LOOKING AT OTHER
CONDITIONS OTHER THAN COVID-19.
CERTAINLY OUR CTSA'S IS AN
EXAMPLE OF HOW COMMUNITY
ENGAGEMENT CAN HELP WITH
INCLUSION OVERTIME AND THAT
GROUP CONTINUES A NUMBER OF
EFFORTS.
THE TRIAL INNOVATION NETWORK HAS
CREATED A NUMBER OF RESOURCES
THAT THEY MAKE PUBLICALLY
AVAILABLE ON THEIR WEBSITE.
SO ANY OF THAT CAN GO TO THE
WEBSITE AND USE THE TOOLS THEY
HAVE.
SO WE'RE TRYING TO BUILD THAT
INFRASTRUCTURE AND HELP OTHERS
REPLICATE THOSE SUCCESSES.
REALLY ACROSS INSTITUTES I THINK
WE'VE SEEN A REAL DEDICATION AND
COMMITMENT TO INCLUSION AND
WE'VE SEEN ESPECIALLY IN LIGHT
OF THE PANDEMIC WE HAVE SEEN
GROUPS INCREASINGLY FOCUS ON
THIS.
I WILL SAY MY BIAS COMING FROM
NIMHD IS ON EVALUATION.
AND I WILL SAY THAT ACROSS NIH
SOME INSTITUTES DO THIS A LITTLE
BIT DIFFERENTLY BUT I THINK WHAT
MAKES SUCCESSFUL INCLUSION IS
CONTINUALLY EVALUATING IT AND
HAVING CONVERSATIONS WITH
PROGRAM OFFICERS AND
INSTITUTIONS HAVING THEIR OWN
METHOD OF ACCOUNTABILITY AND I
THINK WHEN WE LOOK AT INCLUSION
REGULARLY AND ADJUST WHEN THINGS
AREN'T GOING AS PLANNED THAT'S
WHEN WE SEE THEM AS SUCCESS
ACROSS NIH.
>> THANK YOU.
AND FOLLOWING UP WITH THE
EVALUATION YOU MENTIONED IN
2022RPPRs HAVE TO DO THE
ANALYSIS.
HOW HAS COMPLIANCE WITHIN GOING
AND ARE THERE PARTICULAR
CHALLENGES YOU WANT TO HIGHLIGHT
YOU MAY BE ABLE TO THINK ABOUT.
>> AND SO AS I MENTIONED WE PUT
OUT A CLARIFICATION IN 2022 THAT
IS YOU'RE DOING AN NIH DEFINED
PHASE III CLINICAL TRIAL YOU
HAVE TO PUT RACE AND SEX AND
GENDER AND ETHNICITY IN YOUR
OUTCOMES.
IT'S MAKING SURE FOLKS ARE AWARE
OF THE REQUIREMENT THAT IS ONE
PURPOSE OF THE CLARIFICATION TO
GET THAT OUT THERE WHEN WE SEE
IF THESE ANALYSES ARE NOT
INCLUDED WE NOTIFY PROGRAM
OFFICER WHO WILL THEN REACH OUT
TO THE INVESTIGATOR TO DO THAT.
SO WE'RE SEEING INCREASING
COMPLIANCE WITH INCREASED
AWARENESS.
WITH ALL THESE WE NEED THE
ENTIRE SCIENTIFIC COMMUNITY TO
LET PEOPLE KNOW ABOUT THE
REQUIREMENTS TO MAKE COMPLIANCE
EASIER.
>> IS THERE ANY MOVEMENT TOWARDS
DISAGGREGATING THE GROUP WHICH
IS VERY HETEROGENOUS WITH REGARD
TO THE OUTCOMES.
>> THIS WAS INCLUDED ON MARCH
28, OBM ANNOUNCE THE NEW
GUIDELINES AND AMONG THEM
INCLUDE DISAGGREGATED CATEGORIES
FOR FEDERAL AGENCIES AND THERE
ARE A NUMBER OF GROUPS INCLUDING
CHINESE, FILIPINO AND INDIAN,
ETCETERA.
THAT'S THE CASE WITH ALMOST ALL
THE RACIAL AND ETHNIC GROUPS.
THERE'S ALSO A WRITE-IN OPTION
FOR ALL RACIAL AND ETHNIC GROUPS
SO WE ARE AS AGENCIES SUPPOSED
TO ALLOW WRITE-IN.
OMB GAVE US 18 MONTHS TO CREATE
AN ACTION PLAN AND FIVE YEARS TO
IMPLEMENT CHANGES.
WHAT THAT LOOKS LIKE GOING
FORWARD I CAN'T TELL YET BUT
WE'LL WORK ON THAT IN THE NEXT
SEVERAL YEARS AND DO RECOGNIZE
WITH ALL THESE GROUPS REALLY
THERE'S A LOT OF HETEROGENEITY
WITHIN THE GROUPS.
>> ANY OTHER COMMENTS OR
QUESTIONS FROM THE MEMBERS?
WE HAVE ONE SHORT QUESTION.
GIVEN MATERNAL HEALTH WE WERE
WONDERING HOW PREGNANT WOMEN
WERE INCLUDED AND THE
IMPLEMENTATION FOR PRGLAC
SUGGESTING PREGNANT WOMEN BE
INCLUDED.
I WONDERED HOW THAT WAS BEING
CONSIDERED.
>> ABSOLUTELY.
THIS GETS BACK TO THE
HETEROGENEITY WITHIN GROUPS.
WHEN YOU LOOK AT THE NUMBERS YOU
SEE WOMEN ARE INCLUDED AT HIGHER
RATES THAN MEN IN MOST OF OUR
RESEARCH BUT THERE'S CERTAIN
GROUPS WHERE IT'S MOST
CHALLENGING AND PREGNANT AND
LACTATING INDIVIDUALS ARE ONE OF
THOSE GROUPS.
WE ADDRESSED THAT IN INCLUSION
POLICY AND HOWEVER, IT IS
ADDRESSED THROUGH REASONS FOR
EXCLUSION AND ALSO IN BUILDING
RECRUITMENT AND OUTREACH PLAN.
THE INCLUSION POLICIES BEGAN IN
PART BECAUSE OF CONCERNS THAT
INDIVIDUALS WITH CHILD-BEARING
POTENTIAL WERE BEING EXCLUDE
FROM STUDIES AND ONE REASON THAT
COST IS NOT AN ACCEPTABLE REASON
FOR EXCLUDING INDIVIDUALS FROM A
STUDY BECAUSE PEOPLE DIDN'T WANT
TO PAY FOR PREGNANCY TESTS,
RIGHT.
WE ADDRESS THAT IN APPROPRIATE
INCLUSION AND APPROPRIATE
REASONS FOR EXCLUSION AND MAKING
SURE THAT OUTREACH PLANS INCLUDE
ALL GROUPS AND HAVE REASONS FOR
EXCLUDING ANY AND IF ORWH HAS
ANYTHING TO ADD I'D BE HAPPY TO
DEFER TO THEM.
>> A MANNER OF CLARIFICATION DO
YOU EXPRESSLY REQUIRE SOMETHING
RELATED TO PREGNANCY OR NOT?
>> I THINK IN TERMS OF EXPRESS
REQUIREMENTS IT WOULD BE REASON
FOR EXCLUSION.
IF PREGNANT OR LACTATING
INDIVIDUALS WERE INCLUDED FROM A
STUDY WE'D EXPECT JUSTIFICATION
FOR THAT THROUGH THE INCLUSION
POLICY.
>> THANK YOU.
>> YOU'RE WELCOME.
>> THANK YOU SO MUCH FOR MAKING
TIME FOR US THIS MORNING.
YOU GAVE US A COUPLE MINUTES.
WE CAN TAKE A QUICK BREATHER AND
GET STARTED BACK AT 11:00. >> THANK YOU.
>> IF I CAN ASK YOU TO GO TO AS
WE MOVE FORWARD IF I CAN ASK
PEOPLE TO SILENCE THEIR PHONES
AND THEIR TYPING ON THEIR
COMPUTERS.
IT SEEMS TO BE WE'RE HEARING A
LOT OF THE EXTRA BACKGROUND
CHATTER.
OAK.
I THINK WHAT WE'RE GOING TO DO
IS WE'RE JUST GOING TO GO TO THE
OPEN DISCUSSION UNTIL
DR. SCHWETZ GETS HERE AND THEN
WE WILL INTERRUPT THAT.
SO WHY DON'T WE OPEN UP THE
DISCUSSION.
ANY COMMENTS FROM THE DIRECTOR'S
REPORT OR ANYTHING YOU WANT IT
HEAR ABOUT OR FEEDBACK YOU HAVE
FOR US ON ANY PROGRAMS.
DR. JONES.
>> I WANT TO ECHO HOW INCREDIBLY
IMPRESSIVE YOUR REPORT IS IN
DEPTH AND BREADTH.
I FEEL LIKE WHEN YOU ASK FOR
QUESTIONS EVERYTHING HAS BEEN
COVERED AND THERE'S A BIG
CONVERSATION WITH ALL THE RATES
OF CONGENITAL SYPHILIS AND
DURING PREGNANCY AND I WANTED TO
RAISE THAT AS A VERY IMPORTANT
TOPIC AND IF THERE'S ANYTHING
YOU WANTED TO SAY ABOUT THAT,
THANKS.
>> EXCELLENT TOPIC.
VERY IMPORTANT PUBLIC ISSUE
INFECTION RATES OF INDIVIDUALS
OF ALL AGES.
WE ARE IN COMMUNICATION WITH THE
NATIONAL INSTITUTE OF ALLERGY
AND INFECTIOUS DISEASES ABOUT
EFFORTS TO UNDERTAKE AND WE'RE
SITTING ON HHS WIDE SXHT --
COMMITTEES IN THAT SPACE TO LOOK
AT WHERE THE RESEARCH QUESTION
MAY BE WORKING IN COLLABORATIONS
WITH PUBLIC CARE AS A PRIMARY
ISSUE AND WE NEED TO TAKE TIME
TO BE ABLE TO DESIGN RESEARCH
APPROACHES THAT WILL ASCERTAIN
THIS INFORMATION TO ANALYZE THIS
DATA.
ABSOLUTELY.
IT'S ON OUR RADAR.
DR. ROSS HAS BEEN FANTASTIC AND
MY EARLY CONVERSATIONS WITH HER
AND WE ARE PLANNING A LITTLE
INTERNAL BRAIN STORMING SESSION
NEXT.
I HOPE AT THE NEXT MEETING I'LL
BE ABLE TO GIVE YOU MORE
PROGRESS ON UPDATES.
AND DR. SCHWETZ HAS ARRIVED.
HER PREVIOUS MEETING WITH THE
NIH DIRECTOR WENT OVER SO --
>> APOLOGIES I WAS A COUPLE
MINUTES LATE.
I WAS TEXTING FURIOUSLY.
AND IN HER CAPACITY SHE DIRECTS
HER DIVISION OF PLANNING AND
STRATEGIC INITIATIVES KNOWN AS
DPCPSI IN THE OFFICE OF THE
DIRECTOR.
>> AGAIN, APOLOGIES FOR MY
TARDINESS.
GOOD MORNING EVERYONE AND THANK
YOU AGAIN FOR LETTING ME SAY A
FEW WORDS AT THIS MEETING TODAY.
THE 60th MEETING AS IT WERE.
I AM REALLY EXCITED TO BE HERE.
AND DR. CLAYTON AND HER TEAM AND
DR. OTA WANG.
AND JUST BEFORE I SHARE A FEW
WORDS ABOUT DPCPSI AND ORWH AND
YOU SAID WORDS ABOUT MYSELF SO
MAYBE I WON'T TALK ABOUT MYSELF.
>> YOU SHOULD.
>> THAT'S PROBABLY THE LEAST
INTERESTING PART BUT I WILL TELL
YOU I'M A BIO PHYSICIST BY
TRAINING AND I'VE BEEN AROUND
QUITE A BIT AND HELD POSITIONS
IN THE OFFICE OF THE AT THREE
DIFFERENT INSTITUTES.
I LIKE TO SAY I HIT THE
INSTITUTE TRIFECTA AND PART OF
INSTITUTE OF NURSING AND THE
SMALLEST AND MIGHTIEST IN SOME
WAYS AND MID SIZED AND LARGE
INSTITUTE I SERVED AS THE ACTING
PRINCIPAL DEPUTY DIRECTOR OF NIH
BEFORE SHIFTING TO MY CURRENT
POSITION BACK IN NOVEMBER WITH
THE CONFIRMATION OF OUR CURRENT
NIH DIRECTOR.
WITHIN DPCPSI WE COLLABORATIVELY
ADVANCE RESEARCH THROUGH
INNOVATIVE SOLUTIONS AND WE'RE
THE HOME OF STRATEGIC
INITIATIVES PLANNING AND PROGRAM
COORDINATION FOR ACROSS NIH.
AND REALLY DPCPSI IS POISED TO
HELP ADDRESS THE NEEDS OF WOMEN
WHEN IT COMES TO WOMEN'S HEALTH
AND WOMEN'S HEALTH RESEARCH
WHICH I'LL TOUCH ON IN A MOMENT
BECAUSE OF THE FUNCTIONS WE
HAVE.
AND IT REALLY PUSHES FORWARD TO
LEAD THROUGH THE SYNERGISTIC
COORDINATION OF OFFICES AND
FOCUSES ON FOUR MAIN APPROACHES
FOR HELPING TO CATALYZE SCIENCE
AND THE WORK THAT WE DO ACROSS
ALL OF NIH.
THOSE INCLUDE THINGS LIKE
IDENTIFYING AND CATALYZING
RESEARCH TO ADDRESS GAPS IN
OPPORTUNITIES TO HELP FOSTER
COLLABORATIONS ACROSS THE
AGENCY.
TO DEVELOP METHODS AND HELP TO
ENABLE THE RESEARCH GOALS AND TO
SERVE AS AN EXPERIMENTAL TEST
BED FOR INNOVATIVE NIH WIDE
ACTIVITIES TO IMPROVE THE HEALTH
OF THE NATION.
WE HAVE SEVERAL OFFICES WITHIN
DPCPSI THAT ADVANCE SCIENCE
INCLUDING ORWH.
I'M IN THE GOING TO GIVE YOU THE
HISTORY OF ORWH YOU PROBABLY AND
EVERYONE ELSE KNOWS ABOUT THIS
BUT ORWH HAS BEEN AROUND SINCE
1990 AND IT HAS WORKED
TIRELESSLY TO IMPROVE AND
ADVANCE THE HEALTH OF WOMEN AT
THE CORE OF ITS MISSION.
MANY OF OUR 27 INSTITUTES AND
CENTERS OF COURSE SUPPORT
RESEARCH RELEVANT TO THE HEALTH
OF WOMEN AND ORWH ACTS AS A
FULCRUM TO COORDINATE EFFORTS
ACROSS THE AGENCY HELPING
CONNECT THE VARIOUS DOTS AND
ACCELERATE RESEARCH AND
SOLUTIONS FOR WOMEN'S HEALTH
THROUGH A VARIETY OF DIFFERENT
APPROACHES BUT IN PARTICULAR WE
HAVE A COORDINATING COMMITTEE
FOR RESEARCH ON WOMEN'S HEATH
THAT INVOLVES SEVERAL MANY I.C.s
ACROSS THE AGENCY AND THEY RUN
ORWH RUNS A VARIETY OF DIFFERENT
CAREER DEVELOPMENT PROGRAMS AND
WE HAVE THE BIRCWH PROGRAM AND
ORWH PLAYED A KEY ROLE IN ACC
ACCELERATING SEX AS A VARIABLE
PROBABLY EIGHT YEARS NOW AND
HELD MANY RESEARCH HAVEN'T
WORKSHOPS THAT ORWH HELPED
SUPPORT AND CO-FUND WITH THE
I.C.s.
AND IT HAS BEEN MY PRIVILEGE TO
HELP SUPPORT ORW DEVELOP THE
VISION FOR THE FUTURE OF WOMEN'S
HEALTH RESEARCH AND IN THE
COMING MONTH OR SO ---ISH AND IN
THE NEAR FUTURE LATER THIS
SPRING THEY'LL RELEASE THE NEW
NIH-WIDE STRATEGIC PLAN FOR THE
HEALTH OF WOMEN.
NOW, WE'RE DELIGHT THE
ADMINISTRATION RECOGNIZE THE
IMPORTANCE OF RESEARCH ON
WOMEN'S HEALTH AS A PRIORITY IN
THE U.S. AND I THINK YOU
MENTIONED IN YOUR REPORT THAT
PRESIDENT BIDEN'S WHITE HOUSE
INITIATIVE ON WOMEN'S HEALTH
RESEARCH AND THAT RECENT
EXECUTIVE ORDER THEY DEVELOPED
IN SUPPORT OF THAT YEEL PRESENTS
SOME EXCITING OPPORTUNITIES TO
HELP PLAN FUND AND ADVANCE
WOMEN'S HEALTH RESEARCH AT NIH.
AND ON A NATIONAL LEVEL TO
FACILITATE THE WORK ACROSS
INTERAGENCY AND I WILL SAY THAT
THEY TOLD US MULTIPLE TIMES THAT
THE WORK NIH IS DOING IS
REALLY -- WE'RE A LEADER IN THIS
SPACE AND THEY WOULD LOVE TO
HELP FACILITATE BROADER
COORDINATION ACROSS THE FEDERAL
GOVERNMENT.
BUT WE KNOW THERE'S MORE WE CAN
DO TO ADVANCE RESEARCH ON
WOMEN'S HEALTH AND TO HELP
ADDRESS THE GAPS IN KNOWLEDGE
THAT EXIST BECAUSE WE KNOW
HEALTHY WOMEN CONTRIBUTE TO
HEALTHY FAMILIES AND HEALTHY
COMMUNITIES, HEALTHY CITIES,
HEALTHY ECONOMIES AND SO MUCH
MORE BASICALLY AND BENEFITS
EVERYONE.
NIH IS REALLY EXCITED AND
PREPARED TO HELP LEVERAGE THE
RECENT EXECUTIVE ORDER TO
ACCELERATE RESEARCH TO HELP
PREVENT, DIAGNOSE AND TREAT
CONDITIONS THAT AFFECT WOMEN
UNIQUELY, DISPROPORTIONATELY AND
DIFFERENTLY.
JANINE I THINK YOU MENTION THE
OFFICE OF DISEASE PREVENTION
RECENTLY ANNOUNCED IT KICK OFF
AN INTERAGENCY PORTFOLIO REVIEW
EFFORT AND HOST A WORKSHOP NEXT
YEAR ON THE MANAGEMENT OF
MENOPAUSAL SYMPTOMS AS A FIRST
STEP IN THE PROCESS FOR A
PATHWAYS TO PREVENTION PROGRAM.
I KNOW THAT ON THE AGENDA LATER
TODAY THERE'S THE MID LIFE
HEALTH OF WOMEN IN MENOPAUSE
DISCUSSION THAT WILL PROVIDE I'M
SURE AN EXCELLENT OVERVIEW OF
THE TOPIC.
AND THEN WE ALSO JUST ONE LAST
THING TO MENTION THAT I'LL
HIGHLIGHT FOR YOU ALL WE
RECENTLY PUBLISHED A NOTICE OF
SPECIAL INTEREST IN RECEIVING
RESEARCH APPLICATIONS THAT ARE
FOCUSSED ON DISEASES AND HEALTH
CONDITIONS THAT PREDOMINANTLY
AFFECT WOMEN PRESENT OR PROGRESS
DIFFERENTLY IN WOMEN OR ARE
FEMALE SPECIFIC.
SO THAT WAS JUST SORT OF A LOT
OF INFORMATION THAT I JUST
DUMPED AT YOU BUT THE SHORT
VERSION IS THAT WE ACROSS ALL OF
NIH AND ACROSS DPCPSI ARE
EXCITED AT THIS I THINK
IMPORTANT POINT WE'RE AT BOTH
NATIONALLY AND FEDERALLY AND
SCIENTIFICALLY AS WELL TO HELP
COORDINATE AND ACCELERATE ON
WOMEN'S HEALTH AND HONORED TO BE
A PART OF TODAY'S MEETING AND
LOOK FORWARD TO WORKING WITH ALL
OF YOU AND VARIOUS WAYS TO
ADDRESS THE UNIQUE HEALTH NEEDS
AND CHALLENGES FACED BY WOMEN
ACROSS THE LIFE SPAN.
WITH THAT I'LL TURN IT BACK TO
JANINE.
>> THANK YOU, SO MUCH, TARA.
DR. OTA WANG WOULD YOU LIKE TO
INTRODUCE THE NEXT SPEAKER.
WE'RE ON TIME.
>> WE'LL DEFER THE LAST
QUESTIONS AND COMMENTS TO OUR
OPEN DISCUSSION PERIOD SO YOU
HAVEN'T LOST THAT TIME.
I'D LIKE TO INTRODUCE OUR NEXT
SPEAKER.
DR. ELIZABETH BARR AS YOU HEARD
THIS MORNING IS THE NEW
ASSOCIATE DIRECTOR OF THE
INTERDISCIPLINARY RESEARCH.
SHE'S FORMERLY A PROGRAM OFFICER
IN OUR OFFICE WHERE SHE
COORDINATED EFFORTS TO ADVANCE
INTERSECTIONAL GENDER AS A
SOCIAL VARIABLE AND LET EFFORTS
TO ADVANCE HIV RESEARCH FOR
WOMEN.
HER BACKGROUND IN IS GENDER AND
WOMEN'S STUDIES, COMMUNITY-LED
HIV RESEARCH AND PREPRODUCTIVE
JUSTICE AND COMPLETED HER WORK
IN WOMEN AND GERDER STUDIES.
PRIOR TO JOINING ORWH SHE SERVED
ON THE FACULTY AT TOWSON
UNIVERSITY AND UNIVERSITY OF
MARYLAND BALTIMORE COUNTY AND
LED INTERDISCIPLINARY
CROSS-SECTOR PROJECTS TO
INCREASE WOMEN'S ENGAGEMENT IN
CLINICAL RESEARCH.
WELCOME, DR. BARR.
>> THANK YOU SO MUCH.
I'M DELIGHTED TO BE HERE TODAY
TO TALK A BIT ABOUT ENHANCING
COMMUNITY ENGAGEMENT AT ORWH.
COMMUNITY ENGAGEMENT CAN BE
DEFINED AS THE PROCESS OF
WORKING COLLABORATIVELY WITH AND
THROUGH GROUPS OF PEOPLE
AFFILIATED BY GEOGRAPHIC
PROXIMITY TO ADDRESS ISSUES
ADDRESSING THE WELL BEING OF
THOSE PEOPLE.
AND COMMUNITY ENGAGEMENT IS
REALLY KEY TO IMPROVING HUMAN
HEALTH.
REGULAR, MEANINGFUL COMMUNITY
ENGAGEMENT SAY IS A WIDELY
ACCEPTED BEST PRACTICE IN HEALTH
RESEARCH.
IN 2010 THE DIRECTOR'S COUNCIL
PUBLIC REPRESENTATIVES DEVELOPED
A COMMUNITY ENGAGEMENT FRAMEWORK
THAT ARTICULATED VALUES AND
STRATEGY FOR COMMUNITY
ENGAGEMENT.
SOME OF THE BENEFITS OF
COMMUNITY ENGAGEMENT DOCUMENTS
ARE IN THE LITERATURE INCLUDE
INCREASED AND EXPANDED
RECRUITMENT AND RETENTION,
IMPROVED RESEARCH QUALITY,
ENHANCED RESEARCH EFFECTIVENESS,
INCREASED TRUST IN RESEARCH,
DEMONSTRATED RESPECT OR
COMMUNITY AND INCREASED UPTAKE
OF RESEARCH FINDINGS.
ACROSS THE NIH, MULTIPLE
COMMUNITY ENGAGEMENT PROCESSES
ARE IN PLACE TO SUPPORT
COMMUNITY ENGAGEMENT.
A FEW REPRESENTATIVE EXAMPLES
ARE SHOWN HERE AND INCLUDE
EFFORTS IN INTRAMURAL PROGRAMS,
EXTRAMURAL PROGRAMS, COMMUNITY
ADVISORY BOARDS AND COMMUNITY
FORUMS.
ORWH HAS PERSPECTIVES THROUGH AD
HOC EFFORTS.
FOR EXAMPLE, ORWH HOSTED A
NUMBER OF LISTENING SESSIONS
INCLUDING AT THE MOST RECENT
U.S. CONFERENCE ON HIV AND AIDS.
ORWH HAD ISSUED REQUEST FOR
INFORMATION OR RFIs ON SPECIFIC
TOPICS.
THESE ENGAGEMENTS ARE INTEGRAL
TO ORWH PLANNING AND
PROGRAMMATIC EFFORTS.
HOWEVER, THE VALUE OF THESE
ENGAGEMENTS CAN BE CHALLENGING
TO SUSTAIN WITHOUT A SYSTEMATIC
APPROACH AND SUPPORTIVE
INFRASTRUCTURE.
SO TO MEET THE NEED FOR
SUSTAINED COMMUNITY PARTNERSHIP
AND TO ENSURE RESPONSIVENESS TO
AND INPUT FROM THE WOMEN THAT
ORWH SERVES, ORWH PROPOSES
ESTABLISHING A STANDING ACRWH
ENGAGING SUBCOMMITTEE TO BE
COMPRISED OF PATIENTS AND
COMMUNITY MEMBERS.
THE PURPOSE OF THIS SUBCOMMITTEE
IS TO ELICIT REGULAR, ONGOING,
COMMUNITY AND PATIENT-FOCUSSED
INPUT INTO ORWH PROGRAMS AND
PRIORITIES.
THROUGH CONTINUOUS ENGAGEMENT
AND PARTNERSHIP WITH DIVERSE
CONSTITUENTS, THE SUBCOMMITTEE
WILL PROVIDE AN INFRASTRUCTURE
FOR INFORMATION DISSEMINATION
AND COLLABORATIONS AND ALSO
INFORM ORWH PROGRAMMATIC
ACTIVITIES.
POTENTIAL DELIVERABLES FROM THE
SUBCOMMITTEE MAY INCLUDE
COMMUNITY-FOCUSSED HEALTH
INFORMATION FOR EXAMPLE,
WEBINARS OR FACT SHEETS OR
FREQUENTLY ASKED QUESTIONS ABOUT
TOPICS OF RELEVANCE TO THE
HEALTH OF WOMEN.
IN 2023 A SERIES OF MEETINGS
OCCURRED WITH EXISTING NIH
COMMUNITY ENGAGEMENT EFFORTS
WITH THE GOAL OF UNDERSTANDING
BEST PRACTICES AND LESSONS
LEARNED FOR SUSTAINING
MEANINGFUL COMMUNITY ENGAGEMENT
AT NIH.
SOME OF THE EFFORTS THAT WERE
CONSULTED INCLUDED COMMUNITY
ADVISORY BOARDS OR CABS, FOR
EXAMPLE, WITH RAD X UP FOR THE
NIAID RESEARCH NETWORK AND STUDY
AGNOSTIC ENGAGEMENT PARTNERSHIPS
INCLUDING HEAL AND THE NHLBI
HEART HEALTHY NETWORK AND
ONGOING AND DISCREET COMMUNITY
ENGAGEMENT EFFORTS LIKE THE
HIEHS COMMUNITY FORUM.
COMMUNITY ENGAGEMENT EFFORTS
WERE ASKED ABOUT THEIR
STRUCTURE, SCOPE AND LOGISTICS
AND SHARE BEST PRACTICES AND
LESSONS LEARNED.
TWO KEY LEARNINGS EMERGED.
FIRST, COMPENSATION FOR
COMMUNITY MEMBERS' TIME AND
EXPERTISE IS AN ESSENTIAL
ELEMENT OF STRUCTURES.
SECOND, CLARITY OF PURPOSE,
CLARITY OF SCOPE AND CLARITY OF
EXPECTATIONS ARE CRITICAL
ELEMENTS OF SUCCESSFUL COMMUNITY
ENGAGEMENT STRUCTURES.
INITIAL DIALOGUE SHOULD
ASCERTAIN WHAT WILL BE ASKED OF
COMMUNITY MEMBERS, FOR EXAMPLE,
HOW MUCH WILL WILL THEY BE ASKED
TO PARTICIPATE, WHAT TYPE OF
FEEDBACK WILL THEY BE EXPECTED
TO GIVE AS WELL AS CLARIFYING
WHAT SHOULD AND SHOULD NOT BE
EXPECTED FROM ORWH FOR EXAMPLE
HOW WE MAY AND MAY NOT BE ABLE
TO SOLICIT AND IMPLEMENT THEIR
INPUT.
A PHASED APPROACH TO BUILDING
THE SUBCOMMITTEE WOULD ENTAIL
BRINGING ON MEMBERS FOR
EIGHT-YEAR TERMS WITH AN
OPTIONAL FOUR-YEAR AND TAKE THIS
APPROACH INCLUDES THE CAVEAT NOT
ALL PERSPECTIVES WILL BE
REPRESENTED SIMULTANEOUSLY BUT
THE BENEFITS INCLUDE THOUGHTFUL
DEVELOPMENT OF THE INITIATIVE
AND MEET VIRTUALLY AND HYBRID
FORMAT AND DELIVERABLES COULD BE
WEBINARS, FREQUENTLY ASKED
QUESTIONS, SHORT VIDEOS, COMMENT
OR INFO GRAPHICS INFORMED BY THE
INPUT OF THE SUBCOMMITTEE.
POTENTIAL PERSPECTIVES TO BE
INCLUDED ARE SHOWN ON THE SLIDE
IN ALPHABETICAL ORDER AND
GROUPED BY THOSE DISEASE OR
CONDITION AGNOSTIC AND THOSE
CONDITION SPECIFIC.
SO FOR EXAMPLE INCLUDING DIVERSE
POPULATIONS, OLDER WOMEN,
INDIVIDUALS WITH EXPERIENCE OF
SUBSTANCE USE AS WELL AS
INCLUDING PATIENT PERSPECTIVES
FOR EXAMPLE, HIV OR NEUROLOGICAL
DISCOV
DISCOVERIES AND THOSE I PICKED
AT RANDOM.
AND WE WOULD ESTABLISH A
SUBCOMMITTEE TODAY AT THE 60th
MEEKT -- MEETING FOLLOWED BY A
MEMBERSHIP SOLICITATION AND
PROPOSE REVIEWING THE STATEMENTS
OF INTERESTS, HAVING
CONVERSATIONS WITH NOMINEES AND
INVITING THE FIRST ROUND OF
MEMBERS AND IF ALL GOES AS
PLANNED HAVING THE FIRST MEET IN
CONJUNCTION WITH THE FALL ORWH
MEETING.
I'M EAGER TO HEAR YOUR QUESTIONS
AND IDEAS FOR HOW WE MIGHT
IMPLEMENT THE SUBCOMMITTEE AND
WILL NOW ANSWER THEM.
>> WE'LL NOW OPEN THE FLOOR FOR
QUESTIONS AND COMMENTS.
>> I'M INTERESTED IN ARE YOU
WANTING PEOPLE WOULD HAVE
EXPERIENCE IN RESEARCH OR
ADVOCACY OR MORE GENERAL
POPULATION?
>> I THINK IDEALLY WE'D HAVE A
BALANCE BUT THE GOAL IS TO HAVE
INDIVIDUALS SPEAK FROM THEIR
EXPERIENCE AS INDIVIDUALS SO NOT
NECESSARILY FOLKS WHO
PARTICIPATED IN A RESEARCH STUDY
BUT INDIVIDUALS WHO MIGHT BE
ABLE TO SPEAK TO WHAT IT'S LIKE
TO HAVE A PERSON WITH HIV
SEEKING CARE IN THE SOUTHERN
U.S. FOR EXAMPLE.
>> THANK YOU VERY MUCH FOR THE
PRESENTATION.
IT'S VERY EXCITING INITIATIVE.
DO YOU HAVE ANY THOUGHTS ON HOW
YOU'RE GOING TO PLACE THE CALL
FOR NOMINATIONS OR
SELF-NOMINATIONS?
HOW ARE YOU GOING DISTRIBUTE
THAT ACROSS THE COUNTRY IN ORDER
TO GAIN ABOUT WHAT YOU THINK IS
A COMFORTABLE REPRESENTATIVE
SAMPLE THAT LEADS YOU TO THE
SELECTION OF EIGHT.
>> THAT'S A WONDERFUL QUESTION,
DR. SIMON.
SOME STRATEGIES OTHER NIH
EFFORTS HAVE USED INCLUDE
FEDERAL REGISTER NOTICES AND
ANNOUNCES THE LIST SERVES IN
SOCIAL MEDIA.
I THINK POTENTIALLY THERE'S THE
RISK WE RECEIVE A SOFT
NOMINATION FOR MEMBERSHIP OF
EIGHT AND THE RISK WE RECEIVE
LOWER THAN EXPECTED.
THE PHASED APPROACH IS A WAY TO
GUIDE THAT AND KEEP IT
MANAGEABLE SO THAT IF WE NEED TO
RETOOL OUR APPROACH WE CAN
BETTER REPRESENT THE DIVERSE
EXPERIENCES OF WOMEN ON THE
COMMITTEE.
>> AND HAVE YOU HAD SOME
COMMUNITY INPUT TO THIS
SELECTION OF EIGHT AS YOUR
INITIAL AND INTO HOW YOU'LL POSE
THIS?
I STRONGLY RECOMMEND THERE'S
OTHER TOP INITIATIVES THAT HAVE
COMMUNITY AND SPOKEN TO
COMMUNITY PARTNERS AND ADVISORY
BOARDS THEY HAVE TO ACTUALLY
STRUCTURE THIS PROPOSAL.
>> UNTIL THERE'S A SUBCOMMITTEE
WE CANNOT GET ANYONE TO NOMINATE
THEMSELVES FOR IT BUT IT'S OUR
HOPE WHILE NOT EVERYONE WILL BE
COMING WITH EXPERIENCE TO
PARTICIPATE IN A CAB WE MAY DRAW
ON FOLKS WHO HAVE FAMILIARITY
WITH NIH AND RESEARCH AND
COMMUNITY ENGAGED RESEARCH
SPECIFICALLY.
SO I THINK IDEALLY WE'D HAVE
FOLKS WHO ARE ALREADY SOMEWHAT A
PART OF THE ECO SYSTEM AS WELL
AS FOLKS PART OF THE ECO SYSTEM.
>> SORRY FOR MY LACK OF CLARITY.
I MEANT HOW DO COMMUNITY INFORM
THIS PROPOSAL?
>> OKAY.
NOW I UNDERSTAND, THANK YOU.
ONE THING WE HEARD AT LISTENING
SESSIONS AND REQUEST FOR
INFORMATION THAT WE PUT OUT IS
THAT THERE'S A STRONG DESIRE FOR
ONGOING AND SUSTAINED
CONVERSATIONS WITH ORWH THAT
LAPSE BEYOND ONE ENCOUNTER.
THANK YOU FOR CLARIFYING FOR ME.
>> DR. AINYAY.
>> I APPRECIATE THE APPROACH TO
THE WORK.
WHAT'S IT LOOK LIKE IN TERM OF
THEIR ENGAGEMENT TO ORWH OR NIH
BROADER.
>> GREAT QUESTION.
AS A SUBCOMMITTEE OF ACRWH, I
THINK WE DO HAVE -- SINCE
NOTHING IS BUILT YET WE HAVE THE
OPPORTUNITY TO BUILD THINGS AS
WE WISH BUT FOR EXAMPLE THE
SUBCOMMITTEES COULD POTENTIALLY
MEET FOR EXAMPLE THE WEEKEND
BEFORE THE ACRH MEETING AND
PERHAPS A LIAISON.
I THINK WE WANT TO ALLOW SPACE
FOR THE COMMITTEE MEMBERS TO
BUILD WHAT IS USEFUL AND
APPROPRIATE WHILE KEEPING IT
PART OF ORWH AND PERHAPS A
LIAISON ROLE BETWEEN THE
SUBCOMMITTEE AND THE HYBRID
MEETING IN CONJUNCTION AND
VIRTUAL MEETINGS IN THE QUARTERS
WHERE IT DOES NOT MEET IS ONE
STRATEGY.
>> THANK YOU FOR A GREAT
INFORMATION SESSION THERE.
SO JUST WONDERING IF YOU ALL HAD
DONE INFORMATION GATHERING FROM
PCORI BECAUSE THEY HAVE A FOCUS
ON STAKEHOLDER ENGAGEMENT AND
THEY HAVE MANUALS ON IT AND SO
JUST WONDERING IF YOU REACHED
OUT TO THEM.
>> WE CONSULTED SOME OF THEIR
RESOURCES BUT WE HAVEN'T HAD
CONVERSATIONS WITH THEM BUT IT'S
A GREAT SUGGESTION.
THANK YOU.
>> ANYONE ELSE?
THANK YOU, DR. BARR.
>> THANK YOU.
>> THANK YOU FOR THE GREAT
DISCUSSION AND FOR THIS
MORNING'S DISCUSSIONS AND
PRESENTATIONS.
SO AT THIS TIME I'M JUST GOING
TO FORECAST OUR NEXT HOUR OR SO.
WHAT WE WOULD LIKE TO DO NOW IS
HAVE OUR MEMBERS JOIN US REALLY
AT THE SIDE OF THE ROOM TO HAVE
A GROUP PHOTO AND I WOULD ASK WE
CAN SEE YOU ON THE SCREEN THAT
WE'RE GOING TAKE YOU VIRTUALLY
AND TAKE A SCREEN SHOT OF YOU TO
SORT OF INCLUDE YOU INTO OUR
GROUP.
IF WE COULD FIRST DO OUR GROUP
PHOTO AND THEN WE'LL HAVE A
LUNCH BREAK.
WHAT I ENCOURAGE YOU TO DO IS WE
HAVE PEOPLE TO HELP GUIDE YOU
THROUGH THE MAZE OF THE
CAFETERIA AND BE BACK NO LATER
THAN 12:40 BECAUSE THE NIH
DIRECTOR DR. BERTAGNOLLI WILL
START PROMPTLY AT 12:45.
THANK YOU FOR A PRODUCTIVE
MORNING AND LET'S GET OUR PICTURE TAKEN.
SO WE'RE ADJOURNED FOR LUNCH. THANK YOU.
>> WELCOME BACK.
I'D LIKE TO CALL THE MEETING
BACK TO ORDER AND INVITE
DR. CLAYTON.
>> I'M EXCITED FOR YOU TO SHARE
IN THE NEXT PRESENTATION AND
IT'S MY DISTINCT MRSH --
PLEASURE TO INTRODUCE
DR. BERTAGNOLLI THE 17th
DIRECTOR AND SECOND WOMAN TO
HOLD THE POSITION.
SHE HAS A BIG JOB ON HER HANDS
BUT WE'RE THRILLED SHE'S AT THE
HELM AND EXCITED FOR ALL THE
WORK SHE WILL BE DOING.
BEFORE SHE WAS THE NIH DIRECTOR,
YOU KNOW SHE WAS THE 16th
DIRECTOR OF THE NATIONAL CANCER
INSTITUTE, BEFORE THAT AT
HARVARD MEDICAL SCHOOL AND DANA
FARBER INSTITUTE AND JOIN ME IN
GIVING A WARM WELCOME TO
DIRECTOR BERTAGNOLLI.
>> THANK YOU SO MUCH AND THANK
YOU, JANINE.
I'M THRILLED TO BE WITH ALL OF
YOU.
IT'S A 60th MEETING OF THIS
IMPORTANT ADVISORY COMMITTEE.
THAT'S FABULOUS.
I'M GOING TO START WITH
INTRODUCING MYSELF AND A LITTLE
BIT ABOUT MY BACKGROUND BECAUSE
IT REFLECTS ON VISION FOR NIH
AND THOUGHTS ABOUT THE SUPPORT
ACROSS ALL OF NIH FOR WOMEN'S
HEALTH RESEARCH.
SO, ME, BY THE WAY THIS IS ME IN
THE OPERATING ROOM AT THE
CLINICAL CENTER WITH STEPHANIE
GOSS MY FORMER POSTDOC AND
FELLOWSHIP TRAINEE AND I NOW I
GET TO BE HER FIRST ASSISTANT.
IT'S GLORIOUS HERE.
YOU ASK IF I GET TO THE
OPERATING ROOM, I DO BUT I'M THE
ASSISTANT NOW AND MY FORMER
TRAINEE IS THE TEACHER.
IT'S GREAT.
I'M HONORED TO BE AS OF NOVEMBER
OF LAST YEAR THE 17th DIRECTOR
OF NIH BUT STARTED OUT IN A
DIFFERENT PLACE ON THE LEFT.
I GREW UP IN A RANCH IN WYOMING
WHERE MY FAMILY STILL LIVES.
NEAREST HOSPITAL ACTUALLY THE
NEAREST DOCTOR'S OFFICE IS 100
MILES AWAY.
AND IT'S 18 MILES OF UNPAVED
DIRT ROAD JUST TO GET TO
PAVEMENT.
SO IT'S REALLY QUITE A WAYS AWAY
FROM BETHESDA.
IN MY CHOICE OF CAREER THOUGH
EVEN FROM WYOMING I WAS INSPIRED
BY MY UNCLE WHO'S A FAMILY
PRACTITIONER WHO TRAVELED ACROSS
THE ENTIRE STATE OF WYOMING
TAKING CARE OF VETERANS.
I ATTENDED PRINCETON UNIVERSITY
AND CAME BACK WEST TO MEDICAL
SCHOOL TO THE UNIVERSITY OF UTAH
WHICH WAS MY STATE SCHOOL
BECAUSE WYOMING DOESN'T HAVE AI
MEDICAL SCHOOL SO UTAH HAS TO
TAKE US REFUGEES IN.
AND IN MEDICAL SCHOOL I WAS
REALLY FASCINATED BY IMMUNOLOGY.
I THOUGHT I WAS GOING TO BE AN
INTERNIST SPECIALIZING IN
IMMUNOLOGY AND THEN I WALKED
INTO AN OPERATING ROOM AND EVERY
SURGEON YOU MEET ONCE YOU ARE IN
THAT ENVIRONMENT IF YOU'RE A
SURGEON THAT'S THE ONLY PLACE
YOU WANT TO BE SO THAT WAS IT.
I WAS FORTUNATE TO TRAIN IN
BRIGHAM AND WOMEN'S HOSPITAL AND
HARVARD WHERE SERIOUS
FUNDAMENTAL RESEARCH WAS PART OF
TRAINING.
DOESN'T MATTER IF YOU WERE A
SURGEON OR NOT AND DID A
TRAINING IN IMMUNOLOGY.
I KEPT UP THAT INTEREST.
DURING MY RESIDENCY I MET A
PATIENT WITH RARE DISEASE CAUSED
BY A GERM LINE MUTATION OF THE
APC GENE.
REALLY FASCINATED BY THIS
PATIENT AND MORE SO BY THIS
UNBELIEVABLY LOVELY YOUNG MAN
WHO DIED MUCH A VERY LARGE
INTERABDOMINAL DESMOID TUMOR.
IT LOOKS LIKE A NASTY
INFLAMMATORY REACTION AND LED ME
TO BE INTERESTED IN INFLAMMATION
AND TUMORIGENESIS AND LOOKED AT
DRIVERS OF TUMOR FORMATION IN
FAP.
WE LOOKED AT NOW NON-STEROIDAL
INFLAMMATORY DRUGS CAN INHIBIT
TUMOR FORMATION AND REVERSE THE
EFFECTS OF APC MUTATION IN THE
GUT.
THIS IS IMPORTANT BECAUSE 85% OF
REGULAR OLD SPORADIC COLORECTAL
CANCER STARTED BY AN IDENTICAL
DEFECT CREATED BY ABNORMAL APC
SIGNALLING.
IF WE COULD ARGUE OUT THE RARE
DISEASE WE CAN DO A LOT OF WITH
COLORECTAL CANCER.
WE ADD -- HAD AN ANIMAL MODEL
AT NEW YORK PRESBYTERIAN AND
CONTINUED AT DANA HARBOR AND
BRIGHAM AND WOMEN'S HOSPITAL AND
EVENTUALLY OUR DRUGS INHIBITING
TUMORS LED TO STUDY FOR
PREVENTION OF COLORECTAL CANCER
PREVENTING ADENOMAS WITH COX 2
INHIBI
INHIBITORS.
I SUSPECT MANY KNOW THE ING
PUNCH LINE THERE.
FOR PEOPLE AT HIGH RISK OF
COLORECTAL CANCERS THE COX 2
INHIBITOR PREVENTED HIGH RISK
ADD ADENOMA FORMATION AND DRUGS
CAUSED NOT PREVIOUSLY KNOWN
CARDIOVASCULAR TEX TOXICITY ANDW
WE'RE STALLED IN OUR EFFORT TO
TREAT FOR CANCER PREVENTION BUT
KNOW MORE ABOUT THE BIOLOGY OF
WHAT THIS MEANS IT WAS CLEAR IT
WASN'T TO GET US EVERYTHING WE
THESE
WERE GOING TO DO MORE TRIALS AND
I BECAME FOCUSSED ON BIOMEDICALS
IN CLINICAL TRIALS AND LED TO AN
INTEREST IN BETTER DIAGNOSTICS
AND BETTER DATA LEADING TO
INTEREST TO OTHER COLLABORATE
MAKING USE OF ELECTRONIC HEALTH
RECORD AND INCREASINGLY
ARTIFICIAL INTELLIGENCE AND
MACHINE LEARNING METHODS TO
UNDERSTAND DISEASE IN WAYS TO
ALLOW US TO DISCOVER
PATHOBIOLOGY AND TREATMENT.
I CONTINUED ON AT THE NCI
STARTING SIMILAR PROJECTS JUST
FIVE WEEKS AFTER TAKING OVER AS
DIRECT OF THE NIH WAS DIAGNOSED
WITH EARLY STAGE BREAST CANCER.
I GOT TO PARTICIPATE AS A
PATIENT PARTICIPANT INSTEAD OF
RESEARCHER.
FORTUNATELY MY PROGNOSIS IS
EXCELLENT AND I WILL SAY I
LOOKED AT IT AND EVERY SINGLE
TREATMENT THAT I AM RECEIVING
THAT IS LEADING TO SUCH GREAT
SUCCESS IN ME PERSONALLY WAS
FUNDED BY NIH.
THERE'S ROUGHLY 1040 WOMEN WHO
CONTRIBUTED AS RESEARCH
SUBJECTS.
I'M GRATEFUL TO ALL THE WOMEN
FOR BEING ABLE TO MAKE IT
POSSIBLE FOR ME TO HAVE A GOOD
RESULT.
SO IN SUMMARY, MY LIFE
EXPERIENCES I THINK HAVE GIVEN
ME A POWERFUL SENSE OF THE
TRANSFORMATIVE PATIENT OF
RESEARCH AND THE CRITICAL
IMPORTANCE GOING TO WYOMING
WHERE THE HOSPITAL WAS OVER 100
MILES AWAY THE CRITICAL
IMPORTANCE OF ACCESS TO ALL
PEOPLE FOR RESEARCH AND ITS
BENEFITS.
NOW, AS NIH DIRECTOR THE TEAM
HERE THE AMAZING TEAM OF 27
INSTITUTES AND CENTERS AT NIH
THINK ABOUT THINGS OVER ALL IN
TERMS OF WHAT WE NEED TO DO FOR
HEALTH AND ONE OF THE THINGS
THAT CONCERNS US ALL THE MOST IS
THE HEALTH OF THE
U.S. POPULATION IS NOT HEADING
IN THE RIGHT DIRECTION RIGHT
NOW.
OUR LIFE EXPECTANCY IS LOW
COMPARED TO PEER NATIONS.
YOU COULD SEE WE'RE BELOW
CANADA, FRANCE BELOW CHINA.
OUR LIFE EXPECTANCY IS THE PLACE
WHERE VIETNAM IS CURRENTLY.
THIS IS NOT A PANDEMIC ERA
ISSUE.
LIFE EXPECTANCY DROPPED
DRAMATICALLY DURING THE PANDEMIC
OF COURSE AND IT'S SEEN A BIT OF
A REBOUND LIKE ALL THINGS BUT WE
STILL HAVEN'T MADE UP FOR THE
LOSSES THAT WERE HAPPENING
BEFORE THE PANDEMIC HIT.
AND NEXT SLIDE, AND OUR LIFE
EXPECTANCY IS LOW COMPARED TO
PEER COUNTRIES THOUGH WE SPEND
SO MUCH MORE ON OUR HEALTH
SYSTEM.
I SEE TWO MAJOR CHALLENGES THAT
NIH NEEDS TO RESPOND TO IN THIS
REGARD.
FIRST, MANY COMMUNITIES ARE
UNDER REPRESENTED IN RESEARCH.
DATA IS LACKING FOR POPULATIONS
THAT ARE OLDER, UNINSURED,
BELONGING TO MINORITY GROUPS OR
LIVE IN RURAL LOCATIONS AND
SADLY, THESE ARE THE COMMUNITIES
THAT ARE DISPROPORTIONATELY
AFFECTED BY THE VERY ISSUES THAT
ARE CAUSING OUR LIFE EXPECTANCY
TO DECLINE.
THIS LIFE EXPECTANCY IS NOT DUE
TO CANCER TREATMENT, FRANKLY,
IT'S DUE TO AN INCREASED RATE,
INCREASE PROBLEMS WITH DRUG
POISONING, ALCOHOLISM, SUICIDE,
MATERNAL DEATHS AND DEATH AND A
SLOWING -- SIGNIFICANT SLOWING
OF PROGRESS TOWARDS PREVENTION
OF CARDIO METABOLIC DISEASE, IN
OTHER WORDS, THE OBESITY
EPIDEMIC.
THE SAME ISSUES RESPONSIBLE FOR
OUR DECLINE IN LIFE EXPECTANCY
ARE DISPROPORTIONATELY PRESENT
WITHIN COMMUNITIES THAT ARE LEFT
OUT OF OUR RESEARCH.
AND THEN SO WE'RE MISSING THE
PEOPLE WE NEED TO MAKE PROGRESS
ON THIS REALLY IMPORTANT HEALTH
ISSUES BUT WE'RE ALSO NOT
EFFECTIVELY HARNESSING RESEARCH
KNOWLEDGE RIGHT NOW.
FUNDAMENTALLY, FOR ALL THE
WEALTH OF DATA WE'RE ABLE TO
COLLECT FROM OUR BASIC RESEARCH
LABORATORIES ALL THE WAY TO OUR
CLINICS, WE STILL LACK
SUFFICIENT DATA TO GUIDE
CLINICAL CARE AND THE NEXT SLIDE
IS VERY SOBERING.
THIS IS FROM THE FIELD OF
ONCOLOGY, THE SAME ALMOST EXACT
SUPER IMPOSABLE FIGURE COULD BE
FOR CARDIOVASCULAR DISEASE I
FRANKLY DON'T KNOW IF IT'S EVEN
BEEN STUDIED FOR OTHER DISEASES.
WHEN YOU LOOK AT THIS YOU CAN
SEE THESE ARE RECOMMENDATIONS OF
EXPERT PANELS FOR TREATMENT OF
CANCERS, GUIDELINE TREATMENT OF
CANCERS.
ONLY 7% OF ALL OF THOSE
GUIDELINE RECOMMENDATIONS WERE
BASED ON THE HIGHEST LEVEL OF
EVIDENCE.
THE VAST MAJORITY IS BASED ON
LOWER LEVELS OF EVIDENCE, SOLID
OBSERVATIONAL DATA, MAYBE SINGLE
EARLIER STAGE CLINICAL TRIALS
BUT WITHIN CONSENSUS FOR THE
GROUP.
THAT'S MOST OF THE DISEASE AND
YOU CAN SEE HERE WE STILL HAVE
RECOMMENDATIONS THAT ARE BASED
ON MUCH LOWER LEVEL.
AND THE BIG PROBLEM WITH THIS IS
THE EVIDENCE PROGRESS HAS NOT
CHANGED IN A DECADE.
WE HAVE NOT MADE PROGRESS.
THIS IS THE DATA THAT OUR
DOCTORS AND PATIENTS USE TO MAKE
LIFE-ALTERING DECISIONS IN
CLINIC EVERY SINGLE DAY.
AND IT'S NOT NEARLY AS
COMPREHENSIVE AND RIGOROUS AS WE
REALLY NEED.
SO WHAT ARE WE GOING TO DO ABOUT
IT?
WHAT CAN NIH DO?
AT NIH WE SEEK FUNDAMENTAL
KNOWLEDGE ABOUT THE NATURE AND
BEHAVIOR OF ALL LIVING SYSTEMS.
THEN WE STRIVE TO ACQUIRE THAT
KNOWLEDGE FOR SUPPORT OF BASIC,
TRANSLATIONAL AND CLINICAL
RESEARCH AND ALSO HAVE A
CRITICAL ROLE IN HELPING TO
TRAIN AND SUPPORT A CREATIVE AND
DIVERSE SCIENTIFIC WORKFORCE.
SO AMONG OUR MAIN GUIDING
PRINCIPLES AT NIH THE FIRST ONE
IS OUR WORK NOT FINISHED WHEN WE
DELIVER SCIENTIFIC DISCOVERIES.
IT'S WHEN ALL PEOPLE ARE LIVING
LONG AND HEALTHY LIVES AND THAT
NEEDS TO BE A LENS THROUGH WHICH
WE VIEW EVERYTHING.
WE SHOULD CELEBRATE OUR
SUCCESSES.
WE HAVE MANY.
BUT WE HAVE TO REMAIN VERY
HUMBLE IN THE FACE OF HUMAN
SUFFERING.
AND WE HAVE TO APPROACH OUR WORK
WITH GREAT URGENCY BECAUSE
PEOPLE ARE COUNTING ON US.
HERE'S ANOTHER GUIDING
PRINCIPLE, NIH RESEARCH
ENCOMPASSES THE LABORATORY, THE
CLINIC BUT IT DOES NOT STOP AT
THE DOOR TO THE DOCTOR'S OFFICE.
IT
FUNDAMENTAL SCIENCE REMAINS
CRITICAL.
WE'RE LEARNING SO MUCH ABOUT
HUMAN BIOLOGY IN OUR BASIC
RESEARCH LABORATORIES.
AND THIS BIG RUSH OF INFORMATION
COMES IN FROM THOSE LABORATORIES
EVERY DAY.
I SEE THE MANUSCRIPTS COME IN
DAY BY DAY, BELIEVE IT OR NOT.
I HAVE A STEADY STREAM WHICH IS
WONDERFUL BUT WE MUST BE MORE
EFFECTIVE CONNECTING WHAT WE'RE
LEARNING, UNDERSTANDING
INTERPLAY BETWEEN THE GENES WE
INHERIT AND ENVIRONMENTAL AND
SOCIETAL FACTORS THAT SURROUND
US BEGINNING BEFORE BIRTH AND
CONNECTING THAT KNOWLEDGE TO
EVERYDAY LIFE IN CLINICAL
PRACTICE.
WE NEED TO MAKE SURE THAT THE
BIOLOGICAL INSIGHTS IDENTIFIED
IN LABORATORIES ARE PURSUED IN
WAYS THAT SPEED THEIR
APPLICATION TO IMPROVE THE
CIRCUMSTANCES OF REAL PEOPLE.
OUR CLINICAL RESEARCH NEEDS TO
BE EFFICIENT, INCLUSIVE, AND
RESPONSIVE TO THE NEEDS OF
PATIENTS.
NEXT SLIDE.
AND THEN HERE'S THE LAST MAIN
GUIDING PRINCIPLE.
PROGRESS IS ACCELERATED, WHEN
ADVANCED SCIENTIFIC METHODS,
WHICH IS NEW DATA ANALYTICS LIKE
MACHINE LEARNING ARE FOR
EVERYONE AND ARE ADOPTED IN
CLINICAL CARE, WE'RE ONLY DONE
WHEN DISCOVERIES BENEFIT PEOPLE.
WE NEED TO MAKE SURE THAT OUR
TECHNOLOGY AND KNOWLEDGE, NOW
DEVELOPED TO THE POINT THAT WE
CAN DELIVER EVIDENCE-BASED
DATA-DRIVEN HEALTH TO EVERY
PATIENT, WE NEED TO MAKE THAT A
REALITY.
WE ALSO NEED TO TAKE THE
FEEDBACK LOOP.
OBSERVATIONS FROM CLINICAL CARE
SHOULD ROUTINELY INFORM OUR
EVIDENCE BASE, NOT IN AN AD HOC
AND EPISODIC MANNER.
ARTIFICIAL INTELLIGENCE AND
MACHINE LEARNING ARE REALLY
REVOLUTIONIZING WHAT IS POSSIBLE
FOR BIOMEDICAL RESEARCH AND
CLINICAL CARE.
I CAN SAY IT'S A MATTER OF PRIDE
WE HAVE MANY OUTSTAND
RESEARCHERS HERE AT NIH THAT
HAVE BEEN USING THOSE TECHNIQUES
FOR ALMOST TWO DECADES, SO THEY
ARE NOT NEW TO US.
THEY ARE THE NEW TO THE REST OF
THE WORLD THAT CAN NOW USE
ChatGPT, PROBABLY THE LEAST OF
THE METHODS THAT WE HAVE, TAKING
A MUCH CAUSAL APPROACH.
BUT IF WE'RE GOING TO REALIZE
THE POTENTIAL OF THESE NEW
TECHNOLOGICAL METHODS, WE NEED
TO INVEST IN A SECURE AND
SUSTAINABLE DATA SHARING
INFRASTRUCTURE.
SO, WHAT SHOULD NIH DO IN
PRACTICAL TERMS?
NEXT SLIDE.
WE NEED TO MAKE EVIDENCE-BASED
HEALTH CARE AVAILABLE TO ALL.
NEXT SLIDE.
I BELIEVE WE CAN DO THE MOST
GOOD BY PUSHING TO BETTER
INTEGRATE EVERYDAY CARE WITH
RESEARCH.
WE ESPECIALLY WANT TO FOCUS ON
PRIMARY CARE.
AND WE WANT TO EXTRACT BETTER
INFORMATION FROM DATA TO INFORM
CARE.
WHY PRIMARY CARE?
WE NEED TO MEET PEOPLE WHERE
THEY ALREADY RECEIVE CARE SO WE
CAN SUPPORT AND WE NEED TO
SUPPORT PRIMARY CARE PROVIDERS
WHO REALLY ARE ON THE FRONT
LINES OF HEALTH CARE AND ON THE
FRONT LINES OF SO MANY REALLY
CHALLENGING PROBLEMS THAT WE
NEED TO ATTACK, AGAIN I'LL GIVE
YOU THE LIST.
OBESITY, CARDIOVASCULAR RISK,
CANCER SCREENING, MENTAL HEALTH,
MANAGEMENT OF SUBSTANCE ABUSE,
AND ON AND ON.
THESE ARE PRIMARY CARE ISSUES.
WE HAVEN'T REALLY HAD A
COMPREHENSIVE FOCUS ON THAT
ENVIRONMENT AS A CENTER FOR
RESEARCH.
USING INNOVATIVE STUDY DESIGNS,
WE CAN INCREASE RESEARCH
CAPABILITIES TO ADDRESS THESE
URGENT HEALTH ISSUES, LIKE
METABOLIC DISORDERS AND MENTAL
HEALTH, WITH THE GOAL OF
IMPROVING OUR ABILITY TO PREVENT
DISEASE.
PEOPLE SAY THIS OFTEN.
WE WITHIN THE INSTITUTE, WE'RE
NOT THE NATIONAL INSTITUTE OF
DISEASE.
WE'RE THE NATIONAL INSTITUTES OF
HEALTH, AND THAT NEEDS TO BE OUR
FOCUS.
WE CAN BETTER UNDERSTAND -- ALSO
BETTER UNDERSTAND WHAT WORKS IN
TERMS OF IMPLEMENTATION.
MOST IMPORTANT, WE CAN DESIGN
STUDIES AND RESEARCH METHODS
THAT ALLOW US TO ADDRESS
QUESTIONS THAT ARE BROUGHT TO US
BY THE PRIMARY CARE PROVIDERS
AND THE PEOPLE THAT THEY SERVE.
RECOGNIZING THAT HEALTH CARE
PROVIDERS PARTICULARLY PRIMARY
CARE FACE HEAVY DEMANDS ON THEIR
TIME, WE CAN USE TOOLS LIKE THE
ELECTRONIC HEALTH RECORD TO
ENGAGE PEOPLE IN RESEARCH WITH
THEIR PERMISSION AND REDUCE THE
BURDENS OF DATA COLLECTION.
FINALLY, WE ALL ARE WORKING HARD
TOWARD OUR VISION OF A
DATA-DRIVEN SYSTEM IN WHICH
RESEARCH AND INSIGHT FROM
PATIENT CARE ARE CONSTANTLY
INFORMING ONE ANOTHER.
NEXT SLIDE.
IN ADDITION TO CONNECTING
PATIENT CARE TO RESEARCH WE NEED
TO HARNESS RESEARCH AND HEALTH
DATA.
WE HAVE AN ENORMOUS ABUNDANCE OF
DATA.
FEDERAL REGULATIONS REQUIRE THAT
NIH-FUNDED RESEARCHERS SHARE
THEIR DATA PUBLICLY.
SO OUR VISION IS TO INTEGRATE
DATA FROM BASIC AND SOCIAL
SCIENCE RESEARCH, FROM PUBLIC
HEALTH AND CLINICAL CARE.
INCREASE THE CAPACITY FOR DATA
HOSTING.
ENABLE LOW-COST ACCESS TO DATA
USING OPEN INDUSTRY DATA
STANDARDS.
AND SUPPORT BROAD ACCESS TO
ADVANCED ANALYTICS AND
COMPUTATIONAL POWER.
TO DO THIS, WE WILL EMPLOY A
FEDERATED ARCHITECTURE FOR DATA
SHARING, DON'T LOOK TO US TO
HAVE SOME GINORMOUS LAKE OF ALL
THE DATA FROM BIOMEDICAL
RESEARCH BUT INSTEAD KNOW WHERE
THESE DATA LIVE, WHO IS HOSTING
THEM, AND HOW TO BRING THEM
TOGETHER TO TEAMS TO ANSWER
IMPORTANT QUESTIONS.
AND THEN FINALLY WE ALSO NEED TO
PROVIDE EDUCATION AND WORKFORCE
DEVELOPMENT AS A PART OF THIS
DATA SHARING AND ABOVE ALL DATA
USE FOCUS.
NEXT SLIDE.
NOW I'D LIKE TO SHIFT GEARS AND
TALK ABOUT WOMEN'S HEALTH
RESEARCH SPECIFICALLY.
REALLY IT'S BEEN A VERY EXCITING
FEW WEEKS ON THAT FRONT.
ON MARCH 18 I WAS DELIGHTED TO
BE IN THE ROOM WITH DR. CLAYTON,
DR. MAZUR AND I DIRECTORS WHEN
PRESIDENT BIDEN SIGNED AN ORDER
EXPANDING FEDERAL RESEARCH
CONCERNING WOMEN'S HEALTH,
FOLLOWING HIS STATE OF THE UNION
ADDRESS LAST MONTH WHERE HE LAID
OUT A VISION FOR TRANSFORMING
WOMEN'S HEALTH RESEARCH.
FOR FAR TOO LONG, ISSUES
SPECIFIC TO WOMEN HAVE GONE
UNADDRESSED.
EVEN THOUGH NIH REQUIRES AND HAS
FOR QUITE A LONG TIME THAT WOMEN
AND RACIAL AND ETHNIC MINORITY
GROUPS MUST BE REPRESENTED IN
CLINICAL RESEARCH, WE STILL HAVE
IMPORTANT GAPS REMAINING.
A PARTICULAR AREA OF CONCERN HAS
BEEN THE LACK OF STUDY OF
MID-LIFE CONDITIONS SUCH AS
MENOPAUSE, THE UNIQUE WAYS HEART
DISEASE AFFECTS WOMEN AND
AUTOIMMUNE DISEASES, CONDITIONS
THAT DISPROPORTIONATELY AFFECT
WOMEN.
THE WHITE HOUSE INITIATIVE ON
WOMEN'S HEALTH RESEARCH HAS THE
GOAL OF FUNDAMENTALLY CHANGING
HOW WE APPROACH AND FUND WOMEN'S
HEALTH RESEARCH IN THE UNITED
STATES.
NEXT SLIDE.
THE EXECUTIVE ORDER PRESIDENT
BIDEN SIGNED ON MARCH 18 DIRECTS
THE MOST COMPREHENSIVE SET OF
EXECUTIVE ACTIONS EVER TAKEN TO
EXPAND AND IMPROVE RESEARCH ON
WOMEN'S HEALTH.
THESE DIRECTIVES WILL MAKE SURE
WOMEN'S HEALTH RESEARCH IS
INTEGRATED AND PRIORITIZED
ACROSS THE ENTIRE FEDERAL
GOVERNMENT, INCLUDING THE
DEPARTMENT OF DEFENSE, V.A.,
NATIONAL SCIENCE FOUNDATION, AS
WELL AS THE MANY DEPARTMENTS --
MANY AGENCIES OF THE DEPARTMENT
OF HEALTH AND HUMAN SERVICES.
THE EXECUTIVE ORDER ALSO
INITIATED A NEW NIH-WIDE EFFORT
TO INVEST $200 MILLION IN FISCAL
YEAR 2025, TO SUPPORT NEW
INTERDISCIPLINARY PROJECTS IN
WOMEN'S HEALTH RESEARCH.
AND THEN FINALLY IN HIS STATE OF
THE UNION ADDRESS PRESIDENT
BIDEN CALLS ON CONGRESS TO DO
EVEN MORE TO ALLOCATE $12
BILLION TO NIH SPECIFICALLY FOR
WOMEN'S HEALTH RESEARCH.
THIS WOULD BUILD ON THE NIH-WIDE
EFFORT ANNOUNCED IN THE
EXECUTIVE ORDER, AND ESTABLISH A
NATIONWIDE NETWORK OF RESEARCH
CENTERS OF EXCELLENCE AND
INNOVATION IN WOMEN'S HEALTH.
WHICH WOULD SERVE AS NATIONAL
GOLD STANDARD FOR WOMEN'S HEALTH
RESEARCH ACROSS THE LIFESPAN.
NEXT SLIDE.
WE'RE ALL AWARE OF THE NEED FOR
GREATER UNDERSTANDING OF WOMEN'S
HEALTH AND WE AT NIH HAVE MADE
AN ENTERPRISE-WIDE COMMITMENT TO
WOMEN'S HEALTH RESEARCH.
IN FACT, WOMEN'S HEALTH IS ONE
OF THE FIVE CROSS-CUTSING THEMES
WITHIN THE NIH WIDE STRATEGIC
PLAN FRAMEWORK THAT'S BEEN IN
PLACE FOR AT LEAST THE PAST
SEVERAL YEARS.
NEXT SLIDE.
WE NEED MORE RESEARCH THAT
ADDRESSES WOMEN'S HEALTH AND
WELL-BEING ACROSS THE ENTIRE
LIFESPAN.
WE NEED TO INCLUDE FOR INSTANCE
YOUNG WIN IN OUR PRIORITIES.
FOR EXAMPLE, ADOLESCENCE IS A
TIME OF MANY CHALLENGES, AND
THIS LIFE TRANSITION AFFECTS
BOYS AND GIRLS DIFFERENTLY.
FOR EXAMPLE, TEENAGE GIRLS HAVE
MORE CHALLENGE WITH BODY IMAGE
THAT COULD LEAD TO LIFELONG
ISSUES WITH SELF-ESTEEM AND
POTENTIALLY LIFE-THREATENING
DISORDERS, ANOREXIA, BULIMIA.
WE NEED TO MAKE MORE PROGRESS TO
ADDRESS PREVENTION OR TREATMENT
FOR THIS EXAMPLE OF A
SIGNIFICANT FACTOR IN WELL-BEING
OF COUNTLESS WOMEN.
MENTAL HEALTH IN GENERAL IS AN
IMPORTANT OFTEN LIFELONG ISSUE,
AND THE NEW EXECUTIVE ORDER WILL
SUPPORT HEALTHCARE PROVIDERS,
INCLUDING WITH THE NEEDED
TRAINING TO ADDRESS THE HEALTH
OF WOMEN AND CHILDREN AFFECTED
BY MENTAL HEALTH AND SUBSTANCE
USE DISORDERS.
A CROSS-CUTTING THEME AT ALL
AGES IS WE NEED TO BE MORE
COMFORTABLE TALKING ABOUT
CONDITIONS THAT AFFECT OUR
HEALTH.
WE WANT WOMEN TO BE MORE OPEN
ABOUT THEIR HEALTH AND
WELL-BEING SO THEY CAN RECEIVE
THE ATTENTION AND CARE THEY
NEED.
NEXT SLIDE.
IT IS DIFFICULT TO IMAGINE A
GREATER TRAGEDY THAN THE DEATH
OF A YOUNG MOTHER, YET WE'RE
SEEING A DISTURBING NUMBER OF
DEATHS IN THE POSTPARTUM PERIOD
WITH LEADING CAUSES RELATED TO
DEPRESSION, OR SUBSTANCE ABUSE.
OF COURSE, PREGNANCY ITSELF PUTS
AN ENORMOUS STRAIN ON THE BODY
AND RATES OF HYPERTENSION DURING
PREGNANCY ARE INCREASING.
AND CAN BE VERY DANGEROUS.
RISKS OF MATERNAL MORBIDITY AND
TORE MORTAL VARIES ACROSS
GROUPS.
MATERNAL DEATH RATES ARE 2.5
TIMES HIGHER FOR BLACK WOMEN
COMPARED TO WHITE WOMEN.
WE NEED NEW WAYS TO ENSURE WOMEN
SECH THE SUPPORT -- RECEIVE THE
SUPPORT THEY NEED DURING
PREGNANCY AND VULNERABLE TIME
AROUND THE BIRTH OF A CHILD.
THIS ISSUE OR COURSE AFFECTS
WOMEN WORLDWIDE, NIH RESEARCH
HAS AN IMPORTANT ROLE BEYOND OUR
OWN BORDERS.
RECENT RESEARCH SUGGESTS THAT,
FOR EXAMPLE, RELATIVELY
STRAIGHTFORWARD INTERVENTIONS TO
REDUCE POSTPARTUM ANXIETY AND
DEPRESSION CAN BE EFFECTIVE.
AN ARTICLE IN NATURE MEDICINE
LAST MONTH DESCRIBED A LARGE
NIH-SUPPORTED CLINICAL TRIAL IN
PAKISTAN, WITH AN INTERVENTION
IN WOMEN WITH SYMPTOMS OF
ANXIETY THAT REDUCE THE LEVELS
OF ANXIETY AND REDUCED THEIR
DEPRESSION SIX WEEKS AFTER
CHILDBIRTH BY TWO-THIRDS OR
MORE.
THIS KEY STRAIGHTFORWARD STEP
WILL NOT ONLY HELP US IDENTIFY
INTERVENTIONS THAT WORK BUT ALSO
DOES MUCH TO ALLOW US TO
DETERMINE HOW TO DELIVER
EFFECTIVE TREATMENT TO PEOPLE
WHO NEED THEM.
NEXT SLIDE.
I DEEPLY APPRECIATE FROM MY
RURAL UPBRINGING HEALTH CARE,
MATERNAL DESERTS IN RED, LOW
ACCESS TO MATERNITY CARE IN
ORANGE.
OF COURSE, RURAL AREAS ALSO LACK
ACCESS TO QUALITY MEDICAL CARE
BUT SO DO PEOPLE IN MORE DENSELY
POPULATED AREAS BECAUSE OF
POVERTY AND OTHER CONSTRAINTS
LIKE LACK OF ACCESS TO
TRANSPORTATION OR CHILD CARE.
BECAUSE OF THE COMPLEXITY OR
RACISM IN THE SYSTEM SUPPOSED TO
BE CARING FOR THEM.
NIH LAUNCHED THE "IMPROVE"
INITIATIVE IN 2019 IN RESPONSE
TO HIGH RATES OF
PREGNANCY-RELATED COMPLICATIONS
AND DEATHS IN OUR COUNTRY.
THIS INITIATIVE SUPPORTS
RESEARCH TO REDUCE PREVENTABLE
CAUSES AND IMPROVE HEALTH FOR
WOMEN BEFORE, DURING, AFTER
PREGNANCY.
IT INCLUDES EMPHASIS ON HEALTH
DISPARITIES IN POPULATIONS
DISPROPORTIONATELY AFFECTED.
LAST AUGUST IMPROV ESTABLISHED
TEN INITIATIVES TO ADDRESS
FACTORS THAT CAN LEAD TO OR HELP
PREVENT PREGNANCY-RELATED
COMPLICATIONS AND DEATH.
NEXT SLIDE.
EXAMPLE OF IMPROVED PROGRAM IS
IMPROV COMMUNITY IMPLEMENTATION
PROGRAM SUPPORTING RESEARCH TO
ADDRESS THE FACTORS THAT
CONTRIBUTE TO MATERNAL MORBIDITY
AND MORTALITY.
SUCH AS MENTAL HEALTH, SUBSTANCE
ABUSE, PSYCHOSOCIAL FACTORS, AND
SOCIAL AND STRUCTURAL
DETERMINANTS OF HEALTH.
AN EXAMPLE IS BEING CONDUCTED AT
THE UNIVERSITY OF NEBRASKA WITH
THE WINNEBAGO TRIBE.
THE NIH COMMUNITY ENGAGEMENT
ALLIANCE, CEAL, BEGAN AS AN
EFFORT AGAINST COVID-19
DISPARITIES BUT HAS BEEN SO
PROMISING THAT IT WAS EXPANDED
TO ADDRESS OTHER AREAS OF HEALTH
DISPARITIES, INCLUDING MATERNITY
HEALTH, HEALTH KNOWLEDGE,
PRIMARY CARE RESEARCH.
CEAL'S PRIMARY CARE RESEARCH
NETWORK IS AN IMPORTANT STEP
TOWARD OUR GOAL OF DEVELOPING A
NATIONWIDE PRIMARY CARE NETWORK
THAT HELPS US GATHER DATA TO
DRIVE EVIDENCE-DRIVEN HEALTH
CARE.
CEAL'S CARE-NET INCLUDES
PARTICIPANTS IN 40 STATES AND
TERRITORIES.
NEXT SLIDE.
RESEARCH SUPPORTED BY THE
NATIONAL HEART, LUNG AND BLOOD
INSTITUTE HAS FOUND A DISTURBING
INCREASE IN RATES OF CHRONIC
HYPERTENSION IN PREGNANCY FOR
AMERICAN WOMEN OVER TIME.
WITH EFFECT MORE PRONOUNCED IN
RURAL POPULATIONS THAN URBAN.
IN BLACK AND HISPANIC WOMEN MORE
THAN IN WHITE WOMEN.
THIS RISE ISN'T ENTIRELY DUE TO
AGE, THE TRIAL SHOWED TREATING
THIS CONDITION EARLY IN
PREGNANCY REDUCES ADVERSE
OUTCOMES AS SEEN IN THE GRAPH ON
THE RIGHT.
BASED ON THESE FINDINGS, THE
AMERICAN COLLEGE OF OBSTETRICS
AND GYNECOLOGY CHANGED GUIDANCE
FOR TREATING CHRONIC
HYPERTENSION DURING PREGNANCY.
NEXT SLIDE.
ONE OF THE AREAS OF FOCUS, THE
WHITE HOUSE INITIATIVE ON
WOMEN'S HEALTH IS MID-LIFE AND
THE TRANSITION INTO OLDER AGE.
WE STILL HAVE MUCH TO LEARN
ABOUT THE INTERPLAY BETWEEN THE
HORMONAL CHANGES OF MENOPAUSE
AND HEALTHY AGING FOR INSTANCE.
THE WHITE HOUSE INITIATIVE WILL
SUPPORT NEW NIH-FUNDED RESEARCH
ON THE IMPACT OF HORMONAL
CHANGES IN PERIMENOPAUSE AND
MENOPAUSE ON HEART HEALTH, BRAIN
HEALTH, AND BONE HEALTH.
FOR MANY WOMEN, WE ALSO STILL
DON'T KNOW HOW TO HANDLE THE
SYMPTOMS OF MENOPAUSE.
NOT ONLY HOT FLASHES BUT ALSO
LOSS OF SLEEP, A SYMPTOM THAT
HAS A PROFOUND EFFECT ON HEALTH
AND WELL-BEING.
A RECENT NIH-FUNDED STUDY FOUND
CHRONIC SLEEP DEFICIENCY
INCREASES INSULIN RESISTANCE, IN
OTHERWISE HEALTHY WOMEN.
ESPECIALLY AFTER MENOPAUSE.
WOMEN AND DOCTORS ARE LEFT
WITHOUT A WAY TO NAVIGATE OR THE
LONG-TERM CONSEQUENCES OF
HORMONAL CHANGES.
WE MUST ADDRESS THIS.
NIH IS LAUNCHING AN INTERAGENCY
PROCESS TO PULL TOGETHER THE
CURRENT STATE OF EVIDENCE ON
MENOPAUSE-RELATED ISSUES, IN
ORDER TO IDENTIFY GAPS, IN
EXISTING RESEARCH AND DEVELOP
AND EVIDENCE BASED TO GUIDE THE
FIELD FORWARD.
OF COURSE, NIH HAS BEEN STUDYING
THE ISSUES OF MENOPAUSE FOR
QUITE A LONG TIME.
FOR EXAMPLE, THROUGH THE WOMEN'S
HEALTH INITIATIVE STUDY
SUPPORTED BY NHLBI, THE STUDY
MANY MIGHT NOT KNOW IS STILL
GOING AND STILL YIELDING
IMPORTANT RESULTS SUCH AS 2021
FINDING SHOWN ON THE RIGHT THAT
THOSE WHO HAVE HYPERTENSION
DURING PREGNANCY ARE MORE LIKELY
TO EXPERIENCE HEART FAILURE
AFTER MENOPAUSE.
NEXT SLIDE.
ANOTHER FINDING FROM THE WOMEN'S
HEALTH INITIATIVE IS THE
OBSERVATION THAT LIGHT PHYSICAL
ACTIVITY IS ASSOCIATED WITH
REDUCED RISK FOR HEART DISEASE.
THE OBSERVATION LED TO AN
ONGOING INTERVENTIONAL STUDY TO
ASSESS EFFECTS OF PRESCRIBING
PHYSICAL ACTIVITY IN A LARGE
COHORT OF OLDER WOMEN.
NEXT SLIDE.
BEFORE CLOSING I WANT TO TOUCH
ON A COUPLE RECENT ILLUSTRATIVE
EXAMPLES HOW RELATIVELY SMALL
SCALE NIH-FUNDED RESEARCH
STUDIES CAN ALSO HAVE IMPORTANT
IMPLICATIONS FOR HEALTH.
ENDOMETRIOSIS AFFECTS AN
ESTIMATE 1 IN 10 U.S. WOMEN, AND
CAUSING SEVERE PAIN AND
INFERTILITY.
MANY WOMEN ENDURE YEARS OF
SYMPTOMS BEFORE RECEIVING A
DIAGNOSIS, WHICH SOMETIMES IS
ONLY CONFIRMED DURING SURGERY.
AVAILABLE TREATMENTS RANGING
FROM HORMONES TO HYSTERECTOMY
ARE NOT EFFECTIVE FOR EVERYONE.
SOME TREATMENT OPTIONS HAVE A
CHANCE FOR RECURRENCE AND MANY
HAVE CHALLENGING SIDE EFFECTS.
LAST MONTH AN NIH-FUNDED STUDY
ANNOUNCED THAT A NONSTEROIDAL
ANTI-INFLAMMATORY DRUG
FENOPROFEN NOT COMMONLY USED
COULD POTENTIALLY BE REPURPOSED
TO ALLEVIATE PAIN AND
INFLAMMATION IN ENDOMETRIOSIS
SPECIFICALLY.
RESEARCHERS AT THE UNIVERSITY OF
CALIFORNIA, SAN FRANCISCO CHOSE
THIS PARTICULAR DRUG TO TEST
USING COMPUTER ALGORITHM THAT
EVALUATED NEARLY 1300 EXISTING
COMPOUNDS FOR THEIR ABILITY TO
REVERSE GENE EXPRESSION PROFILES
RELATED TO ENDOMETRIOSIS AND ITS
GROWTH.
THE RESEARCHERS USED PUBLICLY
AVAILABLE DATA FROM PEOPLE WITH
ENDOMETRIOSIS TO SELECT
CANDIDATE COMPOUNDS.
FENOPROFEN LOOKS PROMISING
BECAUSE IT RETURNED THE HIGHES
GENE EXPRESSION REVERSAL SCORE
AND BELONGS TO A CLASS OF DRUGS
ONE OF THE FIRST LINE TREATMENTS
FOR THIS DISEASE.
THE EXISTING MEDICAL TREATMENTS
FOR ENDOMETRIOSIS PAIN ARE
UNFORTUNATELY INEFFECTIVE WHICH
LED TO A SEARCH FOR A BETTER
OPTION, AND FENOPROFEN
ADMINISTERED TO A RAT MODEL FOR
ENDOMETRIOSIS SUCCESSFULLY
ALLEVIATED A MARKER FOR
ENDOMETRIOSIS PAIN AND NEED TO
BE CONFIRMED IN PEOPLE.
I LIKE HOW IT SHOWS HOW
MOLECULAR ANALYSES, OPEN
DATABASES, AND LABORATORY
RESEARCH CAN YIELD TOGETHER
IMPORTANT CLUES ABOUT HOW TO
APPROACH STUBBORN PROBLEMS IN
WOMEN'S HEALTH CARE.
NIH SUPPORTS DOZENS OF PROGRAMS
TO PREVENT, DIAGNOSE, AND TREAT
ENDOMETRIOSIS.
NEXT, LAST BUT NOT LEAST, A FEW
WEEKS AGO IN MY NIH DIRECTOR'S
BLOG I TALKED ABOUT FASCINATING
FINDINGS FROM BASIC RESEARCH
THAT SEEM TO HAVE UNCOVERED
FINALLY A CLUE ABOUT WHY MOST
PEOPLE WITH AUTOIMMUNE DISEASES
ARE WOMEN.
AUTOIMMUNE DISEASES MAKE UP A
THIRD MOST PREVALENT CATEGORY OF
DISEASE AMONG WOMEN SURPASSED
ONLY BY CANCER AND HEART
DISEASE.
AS MANY AS FOUR OUT OF EVERY
FIVE PEOPLE WITH AN AUTOIMMUNE
CONDITION ARE WOMEN.
RECENT STUDY FOUND THIS COULD BE
DUE AT LEAST IN PART TO THE
BASIC FACT FEMALES HAVE TWO X
CHROMOSOMES.
MALES HAVE AN X AND Y.
SPECIFICALLY, IT HAS TO DO WITH
THE EXISTENCE OF A MOLECULE
CALLED EXIST THAT HELPS
INACTIVATE ONE OF THE TWO X
CHROMOSOMES IN FEMALES,
NECESSARY TO PREVENT CELLS FROM
PRODUCING TOO MANY PROTEINS
ENCODED ON X CHROMOSOMES TO
CORRECT GENE DOSING DIFFERENCE
BETWEEN MALES AND FEMALES.
BUT THESE MOLECULES CAN ALSO
ENCOURAGE FORMATION OF ODD
CLUMPS OF RNA, DNA, AND OTHER
PROTEINS THAT CAN TRIGGER STRONG
RESPONSES.
IF THEY ACTIVATE XIST IN MALE
MICE PRONE TO AUTOIMMUNE THEY
BECAME MORE SUSCEPTIBLE TO
DEVELOPING A LUPUS-LIKE
CONDITION, FOR EARLY TREATMENT
AND PREVENTION OF AUTOIMMUNE
DISEASES.
IT IS CRUCIAL FOR NIH TO
CONTINUE COMMITMENT TO BASIC
RESEARCH WHICH CAN YIELD SO MANY
UNEXPECTED INSIGHTS.
SO, FINALLY, SO MUCH, NEXT
SLIDE, SO MUCH TO DO.
SO MANY POSSIBILITIES FOR MAKING
THE WORLD BETTER FOR ALL WOMEN
BY ENSURING THAT THEY LEAD LONG
AND HEALTHY LIVES.
WITH THAT I'LL CLOSE AND THANK
YOU SO MUCH FOR THE OPPORTUNITY
TO SPEAK WITH YOU TODAY.
>> THANK YOU SO MUCH, DR.
BERTAGNOLLI.
THE FLOOR IS OPEN FOR QUESTIONS
AND QUESTIONS IN -- FROM THE
ADVISORY COMMITTEE MEMBERS.
>> THANK YOU FOR A WONDERFUL
PRESENTATION.
I LEARNED A LOT.
ONE THING -- YOU MENTIONED
SUBSTANCE ABUSE BUT NEVER
EXPLICITLY MENTIONED CIGARETTE
SMOKING, WREAKING HAVOC ON THE
MANY DISPARITIES YOU MENTIONED
AND DISPROPORTIONATELY WOMEN,
RURAL WOMEN.
SO MUCH MORE WE CAN DO, JUST ONE
EXAMPLE.
MY OWN UNIVERSITY HOSPITAL WE DO
A GREAT JOB OF ASKING PEOPLE IF
THEY SMOKE WHEN THEY ARE
ADMITTED, BUT TERRIBLE JOB OF
DOING ANYTHING ABOUT IT, YET WE
KNOW ABOUT 50% OF THEM WILL DIE
OF SMOKING-RELATED ILLNESS IF WE
DON'T DO SOMETHING.
>> YEAH, WE HAVE INTERVENTIONS
THAT CAN HELP, RIGHT?
AND WORK.
AND YOU'VE JUST GIVEN YET
ANOTHER PITCH FOR OUR PRIMARY
CARE NETWORK AS A PLACE TO BE
ABLE TO GET TO THESE KINDS OF
QUESTIONS.
YOU KNOW, I DID WORK WITH NIH
FOR -- I MEAN NCI FOR MY WHOLE
CAREER AND THESE KINDS OF
PREVENTIONS WERE THE HARDEST FOR
US TO GET A HANDLE ON BECAUSE
OUR CLINICAL RESEARCH EFFORTS
WERE IN ONCOLOGIST OFFICE, NOT
THE PRIMARY DOCTOR, A SIMILAR
PROBLEM ACROSS MOST OF OUR
INSTITUTES AND CENTERS.
WE HOPE TO COMBAT THAT TO HAVE A
MECHANISM EVERYBODY CAN USE, YOU
JUST DESCRIBED A GREAT PLACE FOR
TESTING NEW INTERVENTION.
>> THANK YOU FOR AN
ALWAYS-INSPIRING TALK.
SO, I WAS STRUCK BY THE
INFORMATION THAT YOU PROVIDED
ABOUT THE NUMBER OF PATIENTS
THAT PROVIDED DATA IN BREAST
CANCER TRIALS, AND THE AMOUNT OF
FUNDING THAT WENT INTO THOSE
DISCOVERIES AND COMPELLED BY
YOUR STATEMENT THAT WE'RE NOT
DONE WITH THE DISCOVERIES
BECAUSE ONE THING THAT I HEAR
SOMETIMES AS A BREAST CANCER
SPECIALIST IS, YOU KNOW,
SHOULDN'T WE FOCUS ON ALL OF THE
OTHER DISEASES THAT WE KNOW SO
MUCH LESS ABOUT, AND PERSONALLY
AS A SOCIAL SCIENTIST, SOMEONE
CONCERNED ABOUT INEQUITIES,
THERE'S SO MANY IGNORED
POPULATIONS, WE HAVE NOT MADE
ENOUGH STRIDES IN METASTATIC
DISEASE, IN OLDER WOMEN, IN
RACIAL AND ETHNIC MINORITY
GROUPS, SO THERE ARE SO MANY
ADVANCES THAT WE NEED TO MAKE,
REALLY GLAD YOU GOT CUTTING EDGE
CARE I'M SURE BUT IT'S NOT
REACHING EVERYONE.
AND SO I THINK IT'S INCREDIBLY
IMPORTANT TO HAVE SOMEONE
LEADING NIH WHO EMPHASIZES THAT
WE'RE NOT DONE TILL IT REACHES
PATIENTS AND ALSO TO KEEP US
FROM PITTING PRIORITIES FOR
WOMEN'S HEALTH AGAINST ONE
ANOTHER.
THIS IS ABOUT NEEDING MORE
FUNDING FOR WOMEN'S HEALTH IN
GENERAL.
>> THANK YOU SO MUCH FOR SAYING
THAT.
YOU KNOW, EVERYONE'S GOT THEIR
FAVORITE PIECE OF THIS PUZZLE.
AT NIH WE HAVE TO -- WE'RE HERE
FOR EVERYBODY, FOR EVERYBODY.
AND I HAVE SOME THINGS OF HOPE
FOR THAT ARE.
FUNDAMENTAL SCIENCE REALLY IS
POWERFUL IN BEING ABLE TO
ADDRESS SO MANY THINGS
COMPREHENSIVELY.
SO THAT'S THE PLACE WHERE WE CAN
RAISE ALL THE FUNDAMENTAL
SCIENCE.
THE OTHER ONE IS HEALTH DELIVERY
RESEARCH.
YOU KNOW, IF WE CAN DELIVER
PROPER BREAST CANCER SCREENING
WE CAN DELIVER PROPER TREATMENT
FOR AUTOIMMUNE DISEASES.
YOU KNOW WHAT I MEAN?
SO THOSE TWO ENDS OF THE
SPECTRUM ARE THE GREAT LEVELERS,
IF YOU ASK ME, WHERE WE REALLY
CAN SERVE EVERYONE.
THEN IN THE MIDDLE, YES, EVERY
CONDITION IS DIFFERENT.
WE HAVE 27 INSTITUTES AND
CENTERS, THANK GOODNESS, BUZZ WE
CAN -- THE LAST THING I WANT TO
SAY IS THAT WE'RE WORKING
REALLY, REALLY HARD TO GET RID
OF OUR SILOS.
I'M SO THRILLED, I MEAN THE
RECEPTION AMONG THE DIRECTORS AT
NIH HAS BEEN TREMENDOUS FOR BOTH
OF THESE THINGS, GET RID OF OUR
SILOS SO THAT THOSE -- ANYONE
WHO FOCUSES ON ONE PIECE OF THE
PUZZLE CAN LEARN FROM WHAT'S
GOING ON ALL THE WAY AROUND
THEM.
THE EXAMPLE I'LL GIVE THERE IS
INFLAMMATION.
HOW MANY DISEASES HAVE
INFLAMMATION AT THEIR CORE?
EVEN RESPONSE TO CIGARETTES,
RIGHT?
HOW MANY DISEASES HAVE METABOLIC
SYNDROME AT THEIR CORE, HAVE
ABERRANT IMMUNE RESPONSE AT
THEIR CORE?
YOU KNOW, BUT HAVE WE BEEN AS
GOOD AS WE SHOULD AT TAKING ALL
THE DIFFERENT INSTITUTES AND
CENTERS AND RESEARCHERS THAT
HAVE BEEN STUDYING THOSE THINGS
AND BRINGING THEM TOGETHER?
THIS IS ALSO A REALLY BIG FOCUS
THAT WE'RE WORKING ON ACROSS ALL
OF NIH, WE'RE HOPING THAT --
I'LL SHARE WITH YOU TODAY, WE'RE
HOPING TO MAKE THE NATIONAL
LIBRARY OF MEDICINE A REAL FOCAL
POINT FOR THIS KIND OF DATA
SHARING THAT WILL ALLOW US TO
BRING REALLY DIVERSE COMMUNITIES
TOGETHER.
>> THANK YOU VERY MUCH FOR THE
GREAT PRESENTATIONS.
AMBITIOUS GOALS.
ONCE THE ISSUES WITH
DISSEMINATION OF SCIENCE TO
COMMUNITIES, CONFIDENCE AND
SCIENCE OVERALL, TRUST IN
SCIENCE, A CRISIS EXACERBATED IN
RECENT YEARS, WHAT'S THE NIH
GOING TO DO ABOUT IT?
>> THIS IS A VERY, VERY, VERY
IMPORTANT QUESTION.
THERE'S TWO THINGS I THINK --
WELL, FIRST OF ALL, THERE'S NO
WAY WE'RE GOING TO -- WE CAN'T
ASK FOR TRUST, WE CERTAINLY
CAN'T DEMAND TRUST.
WE HAVE TO EARN TRUST, BY ASKING
PEOPLE WHAT THEY NEED, AND THEN
MAKING IT HAPPEN FOR THEM.
NOT TELLING THEM WHAT THEY NEED.
ASKING THEM WHAT THEY NEED AND
THEN DELIVERING FOR THEM.
SO, HOW ARE WE DOING THAT?
ONE OF THE FEATURES OF THE
PRIMARY CARE NETWORK IS GOING TO
BE THE ABILITY TO ASK THE
PROVIDERS AND THE COMMUNITIES
WHAT QUESTIONS DO YOU WANT?
WHAT QUESTIONS CONCERN YOU?
WHAT ARE YOUR QUESTIONS?
WHAT CAN WE DO FOR YOU?
I'LL BET YOU ACROSS ALL THE
INSTITUTES AND CENTERS OF NIH WE
CAN FIND RESEARCH THAT'S GOING
TO ADDRESS THOSE QUESTIONS BUT
THEY ARE THE ONES ASKING FOR
THEM, NOT US PUSHING ON THEM.
SO OFFERING THEM A LOT OF CHOICE
IN WHAT THEY WANT TO PARTICIPATE
AND DO.
THE OTHER ONE IS I DO BELIEVE
PASSIONATELY IN DATA SHARING BUT
I ALSO BELIEVE THAT WE
SHOULDN'T -- THAT PEOPLE SHOULD
BE ABLE TO OPT IN.
WE'RE ALSO WORKING REALLY HARD
THROUGH THE OFFICE OF DATA
SCIENCE STRATEGY OF AN APPROACH
THAT WE HOPE ARE COLLABORATORS
WITH HEALTH AND HUMAN SERVICES
THAT WILL ALLOW US TO DIRECTLY
ASK PEOPLE, CAN WE USE YOUR
HEALTH DATA FOR RESEARCH?
IF THEY SAY NO, OF COURSE WE
WON'T.
IF THEY SAY YES, WE'VE ALREADY
BUILT TRUST.
CAN WE RECONTACT YOU IF
SOMETHING IS IMPORTANT FOR YOU?
I GUARANTEE YOU EVERYBODY WITH A
RARE DISEASE, EVERY PARENT WITH
A CHILD WITH MUSCULAR DYSTROPHY
OR AUTISM WILL SAY YES, PLEASE
CONTACT ME.
AND THEN WE HAVE A WAY OF
ACTUALLY ENGAGING.
THAT'S THE ONLY WAY WE EARN
TRUST.
WE'RE NEVER GOING TO DO IT WITH
PUBLIC RELATIONS CAMPAIGNS AND
SOUND BITES.
>> DR. SIMON AND DR. ANDERSON?
>> THANK YOU FOR THAT TALK.
AMAZING.
I'M FROM NORTHWESTERN, MELISSA
SIMON.
AS YOU DISPLAYED THAT MASS OF
MATERNITY DESERTS IS THERE AN
EFFORT AT NIH WITH RESPECT TO
THE TRAINING OF THE PIPELINE?
THERE'S ALSO WITH THOSE
MATERNITY DESERTS IN THOSE
AREAS, THOSE ARE ALSO OVERLAYING
WITH THE HIGHEST LEVELS OF
HIGHEST RATES OF MATERNAL
MORBIDITY AND MORTALITY, WITH
DESERTS OF HEALTHCARE PROVIDERS
AND RESEARCHERS THAT FOCUS ON
WOMEN'S HEALTH PROVISION AT THE
SAME TIME, AND THOSE AREAS OF
DESERTS TEND TO NOT HAVE THE NIH
FOCUSED PROGRAMS I GREW UP, AND
A SCHOLAR FROM NICHD A LONG TIME
AGO, ALL TEND TO MAP OUT.
THE BIRCWH IS DOING BETTER WITH
RECEPTIVE GEOGRAPHIC LOCATIONS
BUT IN TERMS OF TRAINING THE
PIPELINE THAT IS ACTUALLY GOING
TO COME FORTH WITH THIS
INNOVATIVE WOMEN'S HEALTH
RESEARCH, WHAT ARE WE DOING
THERE?
>> THERE ARE A NUMBER OF
PROGRAMS ACROSS NIH THAT HAVE
BEEN WORKING REALLY HARD TO
ENABLE RESEARCH IN AREAS THAT
HAVE BEEN LEFT OUT OF RESEARCH
PREVIOUSLY.
THERE ARE SOME -- THERE'S
SOMETHING CALLED THE IDEA CTN,
IDeA STATES, CLINICAL TRIALS
NETWORK, RESEARCH CAPACITY
BUILDING PROGRAMS THAT GET INTO
THOSE DESERTS ON THAT MAP.
THERE ARE -- CEAL, WHICH I
TALKED ABOUT, WHICH IS ALSO A
COLLABORATION ACROSS SEVERAL OF
THE DIFFERENT INSTITUTES.
THESE ARE TRAINING AND WORKFORCE
DEVELOPMENT AND CAPACITY
BUILDING PROGRAMS THAT ADDRESS
THOSE RED AND ORANGE AREAS ON
THE MAP.
NEXT, NOW THAT THERE'S BEEN A
LOT OF EFFORT GOING INTO
CAPACITY BUILDING, TO NOW PUT
THOSE AREAS TO WORK IN REAL --
IN DELIVERING RESEARCH FOR THOSE
COMMUNITIES.
WE HAVEN'T CHOSEN EXACTLY WHICH
THE INITIAL SITES WILL BE FOR
THE PRIMARY CARE NETWORK, BUT
I'LL GIVE A HINT, THEY ARE GOING
TO BE IN THOSE LOCATIONS.
THOSE WILL BE WHERE WE START
FIRST.
THE FUNDING FOR NIH THIS YEAR
WAS MORE THAN WE EXPECTED
BECAUSE I THINK OUR
APPROPRIATORS WILL INCREDIBLY
GRATEFUL BECAUSE, YOU KNOW, WE
GET A LITTLE BIT OF A BUMP.
THEY STILL LEFT US IN A DEFICIT
FOR OUR PROGRAMS SO WE CAN'T
LAUNCH BIG WITH THIS PRIMARY
CARE NETWORK THIS YEAR BUT WE'RE
GOING TO LAUNCH FOCUSED AND
STRONG IN THOSE PARTICULAR
AREAS, WITH THE HOPE OF BEING
ABLE TO EXPAND IN THE NEAR
FUTURE TO COVER THOSE PARTS OF
THE COUNTRY THAT WE KNOW, WHERE
WE KNOW WE NEED TO BE.
>> WILL THOSE PRIMARY NETWORKS
INCLUDE OB/GYNs AS WELL?
>> PRIMARY CARE IS ANY -- THOSE
ARE PROVIDERS THAT SEE PATIENTS
NOT AS AN EPISODIC PROVIDER BUT
AS A CONTINUITY-BASED PROVIDER,
SO THEY WILL DEFINITELY INCLUDE
GYNECOLOGISTS, ANYONE PROVIDING
LONG-TERM CARE AND OBSTETRICIANS
TEND TO, YOU KNOW, YOU COULD
CALL THEM AT EPISODIC PROVIDER,
WE CALL THEM PART OF PRIMARY
CARE.
THAT'S A LITTLE FUDGE, IF YOU
TAKE THE DEFINITION OF PRIMARY
CARE SPECIFICALLY BUT WE VERY
MUCH INTEND TO INCLUDE PRIMARY
CARE.
WHY?
WE'VE GOT TO START ADDRESSING
THE CHALLENGES WITH
PREGNANCY-RELATED ADVERSE
EFFECTS.
THE OTHER ONE THAT'S NOT
TRADITIONALLY PART OF PRIMARY
CARE BUT WE NEED TO BRING IN
LINKS STRONGLY TO MENTAL HEALTH
PROVIDERS.
THOSE ARE THE TWO THAT WE REALLY
NEED TO MAKE SURE, OBVIOUSLY
PEDIATRICIANS ARE THERE AS WELL.
>> MELISSA, YOU'RE AWARE ORWH
HAS BEEN PARTNERING ON THE IDEA
STATES PROGRAM FOR SEVERAL YEARS
NOW AND NOW THERE'S THREE
CENTERS OF BIOMEDICAL RESEARCH
OF EXCELLENCE FOCUSED ON WOMEN'S
HEALTH, ALL THE THINGS ARE
COMING TOGETHER.
>> DR. ANDERSON AND THEN DR.
TEMPLETON.
>> THANK YOU FOR A WONDERFUL
TALK AND COMPELLING PERSONAL
STORY AND ALSO I WANT TO SAY FOR
ELEVATING THE ISSUES OF
ADOLESCENT GIRLS.
I THINK WE OFTEN DON'T PAY
ENOUGH ATTENTION TO THEIR HEALTH
ISSUES.
I WANTED TO DRAW ATTENTION TO
TWO OTHER PIECES YOU'VE HAD AND
BRING THEM TOGETHER.
THAT IS THE LACK OF THE REALLY
HIGH-QUALITY DATA TO GUIDE
CLINICAL PRACTICE, AND THEN WHAT
I SAW WAS A STRONG EMPHASIS ON
NEW ANALYTIC TOOLS WITH SHARED
DATA.
SO WHEN I THINK OF THOSE
ANALYTIC TOOLS, I'M A
STATISTICIAN BY TRAINING, I
THINK THOSE ARE REALLY BEST
SUITED FOR DISCOVERY WORK, IN
MOST CASES.
AND THEY NEED TO BE FOLLOWED UP
BY HIGH-QUALITY STUDIES AN
CLINICAL TRIALS.
MY QUESTION IS HOW IS NIH GOING
TO HELP BUILD THAT PIPELINE TO
FOLLOW ALL THESE NEW
DISCOVERIES, TO THE CLINICAL
TRIALS THAT WE NEED TO GUIDE
CLINICAL PRACTICE?
>> WHAT WE ENVISION IS THAT THE
NATIONAL LIBRARY OF MEDICINE CAN
BE A FOCAL POINT FOR ASKING
QUESTIONS, AND USING DATA TO
ADDRESS QUESTIONS AND BRINGING
TOGETHER COMMUNITIES OF
RESEARCHERS FOCUSED AROUND
PARTICULAR ISSUES, PARTICULAR
AREAS OF PARTICULAR QUESTIONS.
I'LL GIVE AN EXAMPLE.
LET'S SAY THAT YOU CAME TO ME
AND YOU SAID, YOU KNOW, YOU WANT
TO LOOK AT REAL WORLD DATA, DATA
FROM THE CLINICAL CARE
ENVIRONMENT, NATIONWIDE, ABOUT
ADOLESCENT GIRLS' MENTAL HEALTH,
I DON'T KNOW, MAKING THIS UP ON
THE FLY, RIGHT?
THOSE DATA WOULD -- YOU WOULD BE
WHAT WE HOPE TO BUILD AND ARE
WAY TO GETTING THERE, WE WOULD
HAVE WITHIN THE NLM SOMEONE TO
HELP YOU WITH AC ACCESS TO THE
DATASET TO INTERROGATE THE DATA,
SUPPORT THE ANALYTICS, FEDERATED
SYSTEMS, DATA WOULD BE CALLED
IN, CLOUD-BASED ENVIRONMENT
WHERE THEY WOULD HAVE ANALYTICS
SUPPLIED, SUPPORT FOR ANALYTICS.
LET'S SAY YOU WEREN'T A
STATISTICS, NEEDED TO BE LINKED
UP WITH SOMEONE.
THOSE DATA WOULD BE USED TO COME
UP WITH HYPOTHESES, EXACTLY
RIGHT.
AND THEN THAT SAME
ENVIRONMENT -- THEN THAT, YOU
WOULD BE WITHIN NIH, WE WOULD
ALSO INVITE THOSE ACROSS THE
INSTITUTES AND CENTERS WHO ARE
INTERESTED, YOU KNOW, WHO COULD
FURTHER THAT WORK THROUGH THE
DEVELOPMENT INTO CLINICAL TRIALS
COULD ALSO BE INVITED INTO THAT
RESEARCH ENVIRONMENT.
YOU SEE WHAT I MEAN?
WE WOULD HOPE THAT THE DISCOVERY
IDEALLY THOSE WORKING ON
DISCOVERY WOULD BE WORKING HAND
IN HAND IN THOSE CENTERS TO
FURTHER WHAT IS IDENTIFIED.
BUT EVEN IF IT'S NOT, THIS IS
NIH.
WE CAN FIND SOMEBODY WHO CAN
HELP YOU, RIGHT?
>> WHAT I UNDERSTAND IS WORK
FROM DISCOVERY CAN GO INTO
OBSERVATIONAL WORK IN THIS DATA
LIKE YOU'RE TALKING ABOUT AND
THEN WE NEED TO MAKE THE NEXT
STEP, IT MIGHT BE PRIMARY CARE
NETWORK YOU'RE TALKING ABOUT,
COULD BE GETTING INTO THE
CLINICAL TRIALS IS WHAT WE NEED.
>> WE'LL PULL ALL AVAILABLE DATA
RESOURCES TO ADDRESS THE ISSUES,
INCLUDING LEGACY OBSERVATIONAL
TRIALS, AND THE ABILITY TO
LAUNCH CLINICAL TRIALS.
>> KIM?
>> HI.
THANK YOU FOR THE GREAT
PRESENTATION TODAY.
AND A FEW WEEKS AGO, BOTH
AMAZING PRESENTATIONS.
AS A DISCLAIMER, I'M AN
ORTHOPEDIC SURGEON, THAT'S THE
BIAS I BRING IN.
THANK YOU SO MUCH FOR INCLUDING
US, OSTEOPOROSIS IN OLDER WOMEN.
WONDERING IF THERE ARE WAYS OF
ADDING OTHER CONDITIONS, YOU
TALKED ABOUT THE LINK WITH
INFLAMMATION, LACK OF ACTIVITY,
I WOULD BRING IN OBESITY AND
CARDIOVASCULAR RISK, OFTEN FOR
WOMEN THE COMMON LINK AMONG THAT
IS JOINT PAIN AND
OSTEOARTHRITIS.
THAT'S A VERY COMMON CONDITION
AS YOU KNOW TAKEN CARE OF BY
PRIMARY CARE PROVIDERS, FOR
WOMEN IN PARTICULAR THOSE WITH
JOINT PAIN ESPECIALLY OF THE
KNEE AND ESPECIALLY IF THEY HAVE
RADIOGRAPHIC CHANGES CONSISTENT
WITH O.A., THERE'S HIGHER RATE
OF COMORBIDITIES ESPECIALLY
CARDIOVASCULAR DISEASE AND
HIGHER RATE OF
CARDIOVASCULAR-RELATED
MORTALITY.
SO, IS OSTEOARTHRITIS A
CONDITION BEING LOOKED AT IN
OLDER WOMEN, IS THERE PERHAPS A
WAY TO GET THIS ON THE AGENDA AS
AREA OF EMPHASIS WITH
OSTEOPOROSIS?
>> YOU RAISE A GOOD ONE, ONE
THAT'S ALREADY UNDER INTENSE
STUDY FRANKLY IN THE HEAL
INITIATIVE, WHICH IS A REALLY
COMPREHENSIVE, AGAIN,
MULTI-INSTITUTE AND CENTER
EFFORT TO REDUCE OPIOID USE BUT
THE WHOLE PURPOSE OF THE HEAL
INITIATIVE PEOPLE DON'T USE IT
BECAUSE THEY WANT A GOOD TIME.
THEY ARE USING IT BECAUSE THEY
ARE SUFFERING FOR ONE REASON OR
KNOW.
OSTEOARTHRITIS, PAIN IN OLDER
PEOPLE, DUE TO DEGENERATIVE
JOINT DISEASE, IS ONE OF THE --
YOU KNOW, A SIGNIFICANT AREA OF
FOCUS FOR THE HEAL INITIATIVE.
THAT'S ONE EXAMPLE I HAPPEN TO
BE ABLE TO PULL UP IMMEDIATELY.
IN NO WAY I MEANT TO BE
COMPREHENSIVE WHAT WE'VE GOT
GOING ON IN WOMEN'S HEALTH
ACROSS NIH.
THE OTHER THING I'LL TELL YOU
SINCE YOU'RE AN ORTHOPEDIC
SURGEON, ONE HUGE GAP WE HAVE IS
WE DON'T HAVE GREAT DATA FOR
WOMEN ATHLETES, RIGHT?
THE DATA THAT WE HAVE FOR
TRAINING, FOR SUPPORT, FOR CARE,
IS BASED ALMOST ENTIRELY ON MALE
ATHLETES.
IT'S ONE OF THE FEW AREAS THERE
REALLY AREN'T THAT MANY AREAS
WHERE WE DON'T HAVE ANY DATA FOR
WOMEN, BUT SPORTS MEDICINE IS
ONE OF THEM.
WE REALLY LACK REALLY GOOD DATA
ON MUSCULOSKELETAL PHYSIOLOGY
AND HEALTH FOR WOMEN.
SO THAT'S ANOTHER ONE FOR YOU.
>> I WOULD AGREE.
IT'S MOSTLY BECAUSE MOST
STUDIES, THE DATA ISN'T
DISAGGREGATED ON SEX.
IF YOU LOOK AT ANTERIOR CRUCIATE
LIGAMENT ISSUES, LOTS OF
RESEARCH FOCUSED ON ANATOMIC
PARAMETERS DIFFERENT, WHICH IS
GREAT, BUT THERE'S NOT MUCH
SURGICALLY YOU CAN DO TO FIX
THAT, RATHER THAN HAVING A FIX
THAT WOULD BE BASED ON TRAINING.
SO, YES, STUDIES LOOKING AT
NEUROMUSCULAR CONTROL YOU CAN
ADDRESS WITH TRAINING BUT WHEN
LOOKING AT TIBIAL SLOPE AND
NOTCH WITH ACL SIZE, GREAT, BUT
THERE'S NOTHING YOU CAN DO TO
TRY TO ADDRESS THAT FROM A
PREVENTION STANDPOINT.
>> INTERESTING NEW DATA SHOWING
HORMONAL INFLUENCES ON LIGAMENT
INSTABILITY, ANY PREGNANT WOMAN
CAN TELL YOU THAT, IT EXTENDS
WAY BEYOND THAT WE'RE FINDING.
>> KIM, YOU MAY NOT BE AWARE DR.
CRISEL IS IN THE ROOM, I'LL GIVE
A SECOND TO RESPOND.
DO YOU WANT TO MAKE A COMMENT?
>> I DID NOT PLANT THAT
QUESTION.
I'VE BEEN BEAMING HERE EACH TIME
THE SUBJECT COMES UP.
YES, ARTHRITIS INITIATIVE, HUGE
INVESTMENT BY THE INSTITUTE.
THE DATA ARE STILL AVAILABLE AND
THE BIOSPECIMENS, I WANTED TO
POINT OUT THERE'S A BIG HEAL
INITIATIVE FOCUSING ON THE KNEE,
WAIT JOINT AND TISSUES ARE
ENERVATED, AND OSTEOARTHRITIS
BELONGS IN THE PORTFOLIO FOR
WOMEN'S HEALTH RESEARCH.
THANK YOU SO MUCH FOR YOUR
ADVOCACY, KIM.
>> THANK YOU.
I APPRECIATE THAT.
>> I THINK WE'RE GOING TO GIVE
YOU THE LAST QUESTION SO WE CAN
RESPECT DR. BERTAGNOLLI'S TIME.
>> THANK YOU.
SOCIETY FOR WOMEN'S HEALTH
RESEARCH.
I LOVE THE WAY YOU PUT THAT WE
DON'T STOP AT DISCOVERY.
AND THAT IT'S REALLY UNTIL
INDIVIDUALS ARE HEALTHY, SO MY
QUESTION TO YOU, WE OFTEN HAVE
SEEN IN MY SPACE THE
COLLABORATION ACROSS
DISCIPLINES.
I LIKE THE PRIMARY CARE NETWORK
BUT ARE THERE ANY PLANS FOR
EITHER LOOKING AT INFRASTRUCTURE
OR PARTNERING OUTSIDE THE
PRIMARY CARE NETWORK TO MAKE
SURE THE OTHER PROFESSIONS OR
PLAYERS IN THIS SPACE EITHER
BEING PAYERS OR PRACTITIONERS OR
RESEARCHERS ARE ENGAGING TO MAKE
SURE DISCOVERIES MEET THE NEEDS
OF THE POPULATION.
>> I ANTICIPATE THE PRIMARY
CARE NETWORK WILL ADDRESS
STUDIES OF PRIMARY CARE, IS
THERE A BETTER WAY TO HANDLE
OSTEOARTHRITIS IN THE KNEE OF AN
85-YEAR-OLD WOMAN.
IT WILL HELP US HANDLE ISSUES
RELATED TO HEALTH DELIVERY AND
HEALTH CARE.
AND A LOT OF THOSE, YOU KNOW,
ARE GOING TO BE HANDOFFS TO
OTHER SPECIALISTS, COORDINATION
OF CARE WITH OTHER SPECIALISTS,
THAT'S JUST ONE PART.
I UNDERSTAND THAT THERE ARE
SO -- THERE'S A TREMENDOUS NEED
FOR SPECIALTY RESEARCH AND THE
ABILITY TO DO THAT FOR WOMEN AND
TO PROMOTE WOMEN'S HEALTH.
WHAT HAPPENED SO FAR ALL
INSTITUTES AND CENTERS HAVE
THEIR OWN PARTICULAR FOCUS OF
DISEASE, AND I DO THINK AS WE
ARE -- OUR MANDATE IS THAT WE DO
ELIMINATE SILOS AND COLLABORATE
MUCH MORE ACROSS THOSE DISEASES
ON SOME OF THE FUNDAMENTAL
ISSUES THAT UNDERLIE THE
DIFFERENT CONDITIONS.
WHEN IT COMES TO CLINICAL
TRIALS, I WOULD EXPECT TO SEE
OUR INDIVIDUAL INSTITUTES AND
CENTERS THAT MAINTAIN THEIR
SPECIALLY NETWORKS, LIKE THIS IS
NEVER GOING TO REPLACE THE
NATIONAL CLINICAL TRIALS NETWORK
FOR CANCER CLINICAL TRIALS BUT
IT WILL BE A GREAT COMPLEMENT TO
IT.
SAME FOR MANY OF THE OTHER
CONDITIONS THAT AFFECT WOMEN.
LINDSAY, WILL YOU MAINTAIN YOUR
NETWORKS AS THEY ARE WITH
COMPLEMENTS FROM THE PRIMARY
CARE NETWORK?
>> WELL, AS A SMALL INSTITUTE,
WE DON'T HAVE NETWORKS THAT
SUPPORT RESEARCH SO WE'RE REALLY
COUNTING ON THIS PRIMARY CARE
NETWORK TO BE SOMETHING WE CAN
LEVERAGE.
TO YOUR POINT WE'RE HOPING THERE
WILL BE OPPORTUNITIES TO KIND OF
BRING IN THE SPECIALTY CARE, YOU
KNOW, A LOT OF PROBLEMS THAT ARE
MANAGED IN PRIMARY CARE OF
COURSE REQUIRE COORDINATION WITH
SPECIALISTS SO WE WANT TO BE
ABLE TO BUILD OUT FROM THOSE
CORES OF PRIMARY CARE NETWORK,
BUT WE'RE LOOKING TO THIS TO
HELP EXTEND AND SUPPORT RESEARCH
IN OUR AREAS.
>> OUR FIRST FOCUS WILL BE ON
CARE DELIVERY, SPECIFIC PROJECTS
WE CAN GET OUR ARMS AROUND THAT
WILL LET US LAUNCH THAT THROUGH
THE NETWORK.
>> QUICKLY.
>> TO FOLLOW UP ON THE LAST
POINT, THINKING A TAD MORE
UPSTREAM OF PRIMARY CARE, FOR
UNDERSERVED COMMUNITIES THAT
MIGHT HAVE TROUBLE ACCESSING
PRIMARY CARE, THEY WAIT TOO
LATE, BY THE TIME THEY GET TO
PRIMARY CARE THEY LOST
PREVENTIVE EFFORT.
FOLLOWING UP ON YOUR SCREENING
AND OTHERS AROUND PRIMARY CARE
PROVIDERS BUT I WAS THINKING
EVEN IN THE COMMUNITY MORE IN
PUBLIC HEALTH TYPE OF COMMUNITY
SETTINGS.
>> THERE'S A LOT OF DISCUSSION
GOING ON ABOUT THE INTERFACE
BETWEEN PUBLIC HEALTH AND
RESEARCH THAT WE DO AT NIH.
AND THE FIRST STEP TOWARD
UNDERSTANDING THAT, BEING ABLE
TO RESOURCE IT AND BUILD IT IS
FRANKLY IN THE AREA OF DATA
RIGHT NOW.
WE'RE COOPERATING WITH CDC, CMS,
VERY CLOSELY ON OUR DATA, NEW
DATA INFRASTRUCTURE.
THAT WILL HELP US DO THAT.
THANKS.
>> PLEASE JOIN ME IN THANKING
DR. BERTAGNOLLI.
WITH THAT, I THINK WE'LL MOVE TO
THE NEXT PRESENTATION.
I'M DELIGHTED TO INTRODUCE DR.
CAROLYN MAZURE, THE PROFESSOR IN
WOMEN'S HEALTH RESEARCH, AND
PROFESSOR OF PSYCHIATRY AND
PSYCHOLOGY YALE SCHOOL OF
MEDICINE.
BUT IN NOVEMBER SHE JOINED THE
ADMINISTRATION, WHEN THE
PRESIDENT ANNOUNCED THE LAUNCH
OF THE WHITE HOUSE WOMEN'S
HEALTH INITIATIVE, AND SHE WAS
SELECTED TO CHAIR.
THIS IS COMING ALSO OUT OF THE
OFFICE OF THE FIRST LADY, AND I
CAN'T IMAGINE A BETTER PERSON TO
HEAD THIS UP.
DR. MAZURE HAS A LONGSTANDING
RECORD OF BUILDING A WOMEN'S
HEALTH RESEARCH CENTER
INTERDISCIPLINARY AT YALE AND
HER BACKGROUND IS IN THE AREA OF
DEPRESSION.
SUCH A CRITICAL AREA FOR THE
HEALTH OF WOMEN.
PLEASE JOIN ME IN WELCOMING DR.
CAROLYN MAZURE.
>> THANK YOU SO MUCH, JANINE,
FOR THAT INTRODUCTION.
AND MY THANKS TO THE OFFICE OF
RESEARCH ON WOMEN'S HEALTH TO
TALK ABOUT THE FIRST EVER WHITE
HOUSE INITIATIVE ON WOMEN'S
HEALTH RESEARCH.
I THANK DR. BERTAGNOLLI FOR
MENTIONING IT.
IT'S REALLY IMPORTANT THAT IT'S
ON HER MIND AND I OBVIOUSLY
APPRECIATE HER PARTNERSHIP IN
THAT.
SO WHAT I THOUGHT I'D DO TODAY
IS TRY TO DESCRIBE THE
INITIATIVE TO YOU.
IT'S QUITE BROAD, THERE'S A LOT
TO IT.
PEOPLE OFTEN ASK QUESTIONS ABOUT
HOW THIS REALLY WORKS.
THAT'S GOING TO BE MY ATTEMPT TO
DO THAT.
THE INITIATIVE WAS LAUNCHED AS
DR. CLAYTON INDICATED IN
NOVEMBER OF 2023, BY PRESIDENT
BIDEN.
AND IT IS LED BY THE FIRST LADY,
DR. JILL BIDEN.
IN CLOSE COLLABORATION WITH THE
WHITE HOUSE COUNCIL ON GENDER
POLICY.
AND I AM VERY HONORED TO BE THE
CHAIR OF THAT INITIATIVE IN MY
LEAVE FROM MEDICAL SCHOOL.
SO HERE WE ARE, MONICA SHOWED
YOU THIS, IN WHICH WE'RE PRESENT
AT THE SIGNING OF THE
PRESIDENTIAL MEMORANDUM.
AND WHAT I WANT PEOPLE TO
UNDERSTAND, THE OFFICE WAS KIND
ENOUGH TO PUT COPIES OF
FACTSHEETS AND OTHER MATERIAL,
THESE ARE PUBLIC DOCUMENTS FOR
YOU TO ACCESS AND READ IF
THERE'S ANY LACK OF CLARITY THEN
YOU CAN WRITE TO US AND ASK
QUESTIONS.
AND I'LL GET TO THAT IN A
MINUTE.
BUT THE PRESIDENT ESTABLISHED
THIS INITIATIVE ALSO AS DR.
BERTAGNOLLI INDICATED, AND THIS
IS A QUOTE FROM THE PRESIDENTIAL
MEMORANDUM.
FUNDAMENTALLY CHANGE HOW WE
APPROACH AND FUND WOMEN'S HEALTH
RESEARCH.
THIS IS BECAUSE ALTHOUGH WE HAVE
MADE MEANINGFUL PROGRESS IN
RESEARCH, PARTICULARLY OVER THE
LAST TWO DECADES ON THE HEALTH
OF WOMEN, AND A LOT OF THAT FROM
PEOPLE WHO WORKED WITH THIS
OFFICE, AND WORKED WITH NIH
GRANTS AND MANY OF YOU, THERE'S
STILL AN AWFUL LOT WE NEED TO
KNOW.
WE'VE HAD REVOLUTIONARY
DISCOVERIES IN CERTAIN
CONDITIONS AFFECTING WOMEN.
WE'VE INCREASED THE NUMBER OF
WOMEN PARTICIPATING IN CLINICAL
TRIALS.
BUT WE STILL KNOW TOO LITTLE HOW
TO EFFECTIVELY PREVENT,
DIAGNOSE, AND TREAT A WIDE RANGE
OF HEALTH CONDITIONS IN WOMEN
LEAVING WOMEN AND IMPORTANTLY AS
WE'RE HEARING TODAY THEIR HEALTH
CARE PROVIDERS WITHOUT THE TOOLS
NEEDED TO REALLY DEAL WITH THESE
IMPORTANT CONDITIONS.
AND CONDITIONS THAT AFFECT WOMEN
UNIQUELY, SUCH AS ENDOMETRIOSIS,
FIBROIDS, PREECLAMPSIA, A WIDE,
WIDE RANGE, CONDITIONS THAT
AFFECT WOMEN DISPROPORTIONATELY,
EXTREMELY LARGE RANGE,
ALZHEIMER'S DISEASE, MIGRAINE,
WIDE RANGE OF AUTOIMMUNE
DISORDERS 80% OF THOSE IN THE
UNITED STATES ARE WOMEN.
LUPUS, CELIAC DISEASE,
RHEUMATOID ARTHRITIS AS WELL AS,
AND THIS IS REALLY IMPORTANT TO
US, AS WELL AS WOMEN HAVING THE
GREATER LIKELIHOOD TO HAVE
ENDURING CONDITIONS, CHRONIC
CONDITIONS, AS WELL AS MULTIPLE
DISORDERS THAT OCCUR AT THE SAME
TIME.
ALSO CONDITIONS THAT AFFECT
WOMEN DIFFERENTLY THAN MEN.
SUCH AS THOSE FOUND IN HEART
DISEASE, AND IN MOST BRAIN-BASED
DISORDERS.
WHETHER IT'S SMOKING, OR
EPILEPSY, OR MULTIPLE SCLEROSIS,
WHERE WE LOOK WE FIND
DIFFERENCES.
TO CLOSE RESEARCH GAPS AND
PIONEER NEXT GENERATION OF
DISCOVERIES THE PRESIDENT
DIRECTED EACH OF THE
INITIATIVES' MEMBERS INCLUDING
THE DEPARTMENT OF HEALTH AND
HUMAN SERVICES AND NINE AGENCIES
WITHIN DHHS WHICH INCLUDES THE
NIH BUT ALSO CDC, FDA, IT GOES
ON AND ON, THERE ARE NINE
AGENCIES.
WE ALSO INCLUDED A NUMBER OF
FEDERAL AGENCIES BEYOND DHHS
SUCH AS DEPARTMENT OF DEFENSE,
VETERANS AFFAIRS, AND
PRESIDENTIAL MEMORANDUM REQUIRED
THAT ALL OF THESE AGENCIES
WITHIN 45 DAYS OF THE SIGNING OF
THE MEMORANDUM LOOK INTO THEIR
OWN PORTFOLIO AND DECIDE HOW
THEY CAN INCREASE WOMEN'S HEALTH
RESEARCH, FOR THOSE AGENCIES AND
DEPARTMENTS FOR WHICH THEY FUND
EXTERNALLY, THAT WAS REVIEWED
BUT ALSO FOR THE DEPARTMENTS
THAT INTERNALLY ARE LOOKING AT
THE HEALTH OF WOMEN AND DOING
SOME ASPECT OF RESEARCH WE ASK
THEM AS WELL TO THINK ABOUT WHAT
THEY COULD DO TO INCREASE AND
POTENTIALLY ADVANCE WOMEN'S
HEALTH RESEARCH.
SINCE THE INITIATIVE, WE'VE ALSO
DONE A NUMBER OF OTHER THINGS.
SO ONE OF THE THINGS THAT I
THINK IS IMPORTANT TO MENTION AT
THIS JUNCTURE IS THE FACT THAT
WE ENGAGE OVER THE MONTHS OF
NOVEMBER, DECEMBER, JANUARY, AND
STILL INTO MARCH, A LARGE NUMBER
OF LISTENING SESSIONS.
THEY TRULY WERE LISTENING
SESSIONS OF ALL SORTS OF
STAKEHOLDERS.
THAT INCLUDED EVERY DIMENSION
THAT WE COULD THINK OF FROM
PATIENTS TO HEALTH CARE
PROVIDERS TO RESEARCHERS, TO
EXPERTS IN VARIOUS FIELDS, TO
ADVOCACY GROUPS, TO PEOPLE WHO
REPRESENTED SPECIFIC PARTS OF
THE SECTOR THAT WE'RE INTERESTED
IN, AND WE HEARD FROM A LARGE
VARIETY OF PEOPLE, ESPECIALLY
RESEARCH EXPERTS, ACROSS THE
NATION IN VARIOUS SPECIALTIES
ABOUT WHAT'S NEEDED.
AND SINCE THE INITIATIVE BEGAN,
IT WAS REALLY DR. BIDEN, DR.
JILL BIDEN, WHO IS LEADING THE
WAY.
AND IT'S USEFUL I THINK FOR US
TO KNOW IN THIS DAY AND AGE THAT
THE TRUTH OF THE MATTER IS DR.
BIDEN IS VERY DEDICATED TO THIS
AND WANTED TO LEARN MORE ABOUT
IT.
SO WE TRAVELED, WE TRAVELED TO
DIFFERENT LABORATORIES AND
PLACES AROUND THE COUNTRY, FROM
CALIFORNIA TO ILLINOIS, TO
GEORGIA, TO MASSACHUSETTS,
TOURING RESEARCH LABORATORIES,
ENABLING THESE RESEARCHERS TO
TALK WITH HER AND US ABOUT THE
QUESTIONS THEY ARE TRYING TO
ANSWER, WHY THEY ARE IMPORTANT,
AND WHY RESEARCH CAN DO THAT.
SO THAT SHE HAD A FUNDAMENTAL
UNDERSTANDING WHEN SHE STANDS UP
AND MAKES REMARKS ABOUT THE
IMPORTANCE OF THIS.
SO, WE HAD LAB TOURS, WE HAD
LISTENING SESSIONS.
AND HEARD FIRST HAND ABOUT
HEALTH CONCERNS WOMEN FACE AND
CUTTING-EDGE RESEARCH THAT'S
POSSIBLE WHEN WE INVEST IN
WOMEN'S HEALTH.
AND ABOUT WHAT WE MUST DO TO
SUPPORT THE BREAKTHROUGHS WE
NEED IN CRITICAL AREAS, FOR
EXAMPLE IN WOMEN'S HEART HEALTH,
GREATEST CAUSE OF DEATH FOR
WOMEN IN OUR NATION.
THROUGHOUT ALL THESE EXPERIENCES
AND DISCUSSIONS, WE LISTENED FOR
OPPORTUNITIES FOR CHANGE THAT
WOULD CHANGE WOMEN'S HEALTH
RESEARCH.
AND AMONG THESE RECURRING THEMES
I'D LIKE TO SHOW YOU A FEW.
AND THESE WERE REALLY THE MOST
PREVALENT, PROMINENT THEMES.
FIRST, THE IMPORTANCE OF
ADDRESSING HEALTH DISPARITIES,
INCLUDING IN CLINICAL TRIAL
PARTICIPATION, AND ONE OF THE
THINGS WE LEARNED IN TERMS OF
RETENTION.
THAT IS AN ENORMOUS PROBLEM FOR
US TO FACE.
SECONDLY, INCREASING
INTERDISCIPLINARY
COLLABORATIONS, SO YOU'VE HEARD
THAT MANY OF US HAVE BEEN
THINKING ABOUT INTERDISCIPLINARY
WORK FOR A LONG TIME,
FORTUNATELY NIH IS THINKING
ABOUT IT IN A PRIMARY WAY.
THERE'S A GREAT MOVE IN THAT
DIRECTION.
WE HAVE TO MOVE FASTER IN THAT
DIRECTION.
SO, INCREASING INTERDISCIPLINARY
COLLABORATIONS REALLY TO HELP US
ANSWER THE COMPLEX QUESTIONS
THAT COME UP IN HEALTH AND
PARTICULARLY IN WOMEN'S HEALTH,
A LA CHRONIC DISORDERS, A LA
COMORBID DISORDERS.
AND THEN FINALLY TRANSLATING
CRITICAL RESEARCH FINDINGS INTO
THE MARKETPLACE IN A MUCH MORE
TIMELY WAY.
I HEARD THAT COME UP TOO IN SOME
OF THE DISCUSSIONS TODAY.
SO, THIS IS AN EXAMPLE OF HOW WE
HAVE TAKEN LISTENING AND WE'VE
TRIED TO APPLY IT.
WE WORKED WITH ARPA-H AND IN
MARCH OF 2024 THE FIRST LADY
TRAVELED TO CAMBRIDGE TO
ANNOUNCE ARPA-H'S FIRST EVER
SPRINT FOR WOMEN'S HEALTH.
FOR THOSE THAT MAY NOT BE
FAMILIAR WITH ARPA-H, IT'S
ADVANCED RESEARCH PROJECTS
AGENCY FOR HEALTH.
AND THE INITIAL COMMITMENT THAT
THEY HAVE MADE FOR THIS CURRENT
YEAR IS $100 MILLION.
PEOPLE ARE NOW APPLYING FOR THAT
MONEY, ACTIVELY, AND WE ARE VERY
EXCITED ABOUT THE POSSIBILITIES
THAT MIGHT COME FROM THAT
BECAUSE WHAT THEIR SPECIALTY IS,
IS REALLY TO IDENTIFY
INDIVIDUALS, GROUP THEM TOGETHER
TO SOLVE A PARTICULAR PROBLEM,
AND THEN TAKE THAT SOLUTION TO
THE MARKETPLACE.
WHICH IS SOMETHING THAT'S REALLY
NOT DONE SUFFICIENTLY IN OUR
VIEW.
UNDERRER THE LEADSHIP THE SPRINT
TOOL WILL ACCELERATE DISCOVERIES
FROM EARLY STAGE PROOFS OF
CONCEPT TO PRODUCTS READY TO BE
COMMERCIALIZED, AS INDICATED
THEY WOULD PLAN TO SUPPORT, THEY
ARE AWARE OF CHALLENGES MANY
WOMEN FACE.
I WANT TO READ YOU A QUOTE FROM
THEIR WORK.
ALTHOUGH TECHNOLOGY IS CAPABLE
OF DIAGNOSES AND POSSIBLY
TREATING DISEASES ACROSS ALL
AGES AND STAGES OF A WOMAN'S
LIFE, ARE INCREASINGLY POSSIBLE,
VERY FEW ARE AFFORDABLE.
AND/OR CURRENTLY AVAILABLE IN
THE MARKETPLACE, OR ARE EASY TO
USE.
SO, AGAIN, OUT OF THE LISTENING
SESSIONS WE'RE TRYING TO PAY
ATTENTION TO WHAT PEOPLE NEED TO
WHAT WOMEN NEED, AND ARPA-H
WANTS TO CHANGE THAT LANDSCAPE.
AND THIS IS JUST THE BEGINNING.
SO THIS IS THE PRESIDENT OF
COURSE IN THE STATE OF THE UNION
IN WHICH HE ASKED FOR CONGRESS
TO MAKE A BOLD TRANSFORMATIVE
INVESTMENT IN WOMEN'S HEALTH
RESEARCH OF $12 MILLION.
YOU MIGHT ASK, WHAT WOULD WE USE
THAT MONEY FOR?
AND SO, THERE WERE TWO PRIMARY
GOALS FOR THAT PARTICULAR ASK.
FIRST, A CENTRAL FUND FOR
WOMEN'S HEALTH AT THE NIH TO
ADVANCE INTERDISCIPLINARY
SCIENCE.
AND WHAT WE HAVE IN MIND IS THE
NEED TO SPUR INTERDISCIPLINARY
SCIENCE SPECIFICALLY ON WOMEN'S
HEALTH RESEARCH.
THIS WOULD SIT WITHIN THE NIH
BUDGET, AND IT WOULD INVITE
DIFFERENT AREAS OF SCIENCE TO
WORK TOGETHER TO ANSWER COMPLEX
QUESTIONS REQUIRING MULTIPLE
DISCIPLINES AND LEVELS OF
EXAMINATION.
AND THIS INCLUDES AREAS OF
RESEARCH THAT CUT ACROSS HEALTH
AREAS THAT DON'T EXPLICITLY FIT
INTO THE MANDATES OF INSTITUTES
AND CENTERS.
IN ADDITION, THIS MONEY WOULD
CREATE A NEW NATIONWIDE NETWORK
OF RESEARCH CENTERS OF
EXCELLENCE AND INNOVATION THAT
WOULD PIVOT OFF THE EXISTING
SUCCESS OF THE SCORES.
AND INCLUDE INNOVATION IN A NEW
WAY THAT SPURS TRANSLATION OF
RESEARCH.
AS WE WORK WITH CONGRESS NOW,
OVER THE NEXT NUMBER OF MONTHS,
TO SECURE THESE INVESTMENTS,
WE'RE TAKING EXECUTIVE ACTION TO
ADVANCE WOMEN'S HEALTH RESEARCH.
AND WHAT I'M ABOUT TO SHOW YOU
ARE PIECES OF THE PUZZLE THAT
WE'RE PUTTING TOGETHER HOW TO
MAKE CHANGE AND I'M GOING TO
GIVE SOME EXAMPLES OF WHAT THE
AGENCIES ARE GOING TO DO.
SO, FIRST OF ALL, AS THE
AGENCIES TAKE ACTION, THE NIH IS
LAUNCHING A NEW NIH-WIDE EFFORT
TO CLOSE GAPS IN WOMEN'S HEALTH
RESEARCH ACROSS THE LIFESPAN AND
THAT'S GOING TO BE SUPPORTED BY
$200 MILLION FROM NIH IN THIS
FISCAL YEAR COMING UP.
FY 25.
SO YOU HAVE TIME TO WRITE YOUR
APPLICATION.
AND IMPORTANTLY, THE NIH WILL
ALSO ESTABLISH AN INITIATIVE ON
BIOMARKER DISCOVERY AND I THINK,
AGAIN, MONICA -- DR. BERTAGNOLLI
ALLUDED TO THIS IN SOME WAYS.
AND WE THINK THIS IS REALLY
QUITE IMPORTANT.
WHAT I SKIPPED OVER AND I WANT
TO GO BACK TO THOUGH IS IN
ADDITION TO THE FY 25 BUDGET
REQUEST, THAT WOULD BE THE $12
BILLION, WE ALSO WOULD DOUBLE
THE CURRENT BUDGET FOR THE
OFFICE OF RESEARCH ON WOMEN'S
HEALTH.
BECAUSE THIS OFFICE PLAYS SUCH A
CRITICAL ROLE AND NEEDS TO HAVE
MORE SUPPORT IN THEIR EFFORTS.
AND THIS WOULD SUPPORT NEW AND
EXISTING EFFORTS THAT EMPHASIZE
WOMEN'S HEALTH RESEARCH.
SO, BACK TO THE NIH AND WHAT
ELSE THEY ARE DOING OUT OF
WONDERFUL RECOMMENDATIONS THEY
MADE TO US WILL ESTABLISH THIS
INITIATIVE ON BIOMARKER
DISCOVERY I BEGAN TO MENTION AND
THEY ARE GOING TO LAUNCH FIRST
EVER PATHWAY TO PREVENTION IN
MENOPAUSE AND TREATMENT OF
MENOPAUSAL SYMPTOMS AND KICKING
OFF AN EFFORT TO IDENTIFY NEW
COMMON DATA ELEMENTS RELATED TO
WOMEN'S HEALTH.
I THINK YOU HEARD ABOUT THAT AND
WE CAN TALK MORE ABOUT THAT AS
WELL.
SO, IMPORTANTLY, IF WE GO BEYOND
THE NIH, WE CAN LOOK AT A FEW
OTHER OPPORTUNITIES THAT
AGENCIES ARE TAKING ADVANTAGE
OF.
NATIONAL SCIENCE FOUNDATION, FOR
THE VERY FIRST TIME, IS BROADLY
CALLING FOR NOVEL AND
TRANSFORMATIVE RESEARCH FOCUSED
ENTIRELY ON WOMEN'S HEALTH
TOPICS.
THEY PUT OUT WHAT THEY CALL A
DEAR COLLEAGUE LETTER, SOUNDS SO
MUCH NICER THAN A REQUEST, RFA,
NOFO, BUT THAT'S WHAT THEY DO.
THEY ARE PUTTING ONE OUT
EXPLICITLY FOR WOMEN'S HEALTH
RESEARCH FOR THE FIRST TIME
EVER.
DEPARTMENT OF DEFENSE AND
DEPARTMENT OF VETERANS AFFAIRS
ARE LAUNCHING A NEW WOMEN'S
HEALTH RESEARCH COLLABORATIVE,
AND THAT'S DESIGNED TO IMPROVE
HEALTH OUTCOMES BOTH FOR
VETERANS AND FOR ACTIVE
SERVICEWOMEN.
THE CENTERS FOR MEDICARE AND
MEDICAID SERVICES, CMS, IS
TAKING STEPS TO ENSURE NEW
MEDICAL SERVICES.
AND THEY ARE GOING TO STRENGTHEN
THEIR REVIEW PROCESS IN THIS
ACTION, INCLUDING COVERAGE WITH
EVIDENCE DEVELOPMENT GUIDANCE TO
ENSURE THAT THE NEW MEDICAL
SERVICES AND TECHNOLOGIES THAT
ARE PUT FORWARD FOR USE IN CARE
OF WOMEN, THAT THEY WORK WELL
FOR WOMEN.
THIS WILL HELP ENSURE THAT
MEDICARE FUNDS ARE USED FOR
TREATMENTS WITH SUFFICIENT
DATABASE, TO SHOW THEY ACTUALLY
WORK IN WOMEN, WHO MAKE UP MORE
THAN HALF OF THE MEDICARE
POPULATION.
THE CENTERS FOR DISEASE CONTROL,
CDC, IS ALSO PARTICIPATING IN
THIS.
I DID DO IT RIGHT.
I MOVED IT BACK.
THE CDC IN COLLABORATION WITH
CDC FOUNDATION AND AMERICAN
BOARD OF OBSTETRICS AND
GYNECOLOGY IS EXPANDING TRAINING
IN WOMEN'S HEALTH RESEARCH AND
PUBLIC HEALTH SURVEILLANCE TO
OBSTETRICIAN GYNECOLOGISTS,
NURSES, ADVANCED PRACTICE
NURSES.
SO, HERE WE ARE NOW.
AND THIS IS THE SIGNING OF THE
EXECUTIVE ORDER THAT TOOK PLACE
ON MARCH 18 OF THIS YEAR.
AND THERE WAS JUST A TREMENDOUS
EXCITEMENT THAT DAY, AND I JUST
THINK IT'S REALLY EXTRAORDINARY
WHAT WE ALL EXPERIENCED WHO WERE
THERE THAT DAY AND SAW THE
OPPORTUNITIES THAT WERE IN FRONT
OF US.
AND THE EXECUTIVE ORDER OR HOW
WE OFTEN REFER TO IT AS THE
E.O., THE PRESIDENT ADDRESSED
THE NATION REALLY IN TERMS OF
THE NEED FOR FURTHER ACTION IN
REGARD TO WOMEN'S HEALTH
RESEARCH, AND THAT'S THE BASIS
OF THE EXECUTIVE ORDER.
IT DIRECTS THE MOST
COMPREHENSIVE SET OF EXECUTIVE
ACTIONS EVER TAKEN TO ADVANCE
WOMEN'S HEALTH RESEARCH.
AND IN THIS, THE PRESIDENT
REITERATES THAT EXISTING, QUOTE,
RESEARCH GAPS MEAN THAT WE KNOW
FAR TOO LITTLE ABOUT WOMEN'S
HEALTH ACROSS WOMEN'S LIFESPANS
AND THOSE GAPS ARE EVEN MORE
PROMINENT FOR WOMEN OF COLOR,
OLDER WOMEN, WOMEN WITH
DISABILITIES.
AND WE HAVE TO START PAYING
DIRECT ATTENTION TO THIS TYPE OF
IMPORTANT PRONOUNCE.
.
THE PRESIDENT IS DIRECTING
MEMBERS OF THE INITIATIVE, THE
AGENCIES, INCLUDING THESE
FEDERAL DEPARTMENTS AND OTHERS
TO DO SEVERAL THINGS.
FIRST, TO INTEGRATE WOMEN'S
HEALTH ACROSS THE FEDERAL
RESEARCH PORTFOLIO.
SO, INTEGRATING THE BROAD SCOPE
OF HEALTH CONDITIONS AFFECTING
WOMEN ACROSS THE FEDERAL
RESEARCH PORTFOLIO IS GOING TO
BE DONE BY STRENGTHENING
RESEARCH AND DATA STANDARDS THAT
ARE RELATED TO WOMEN'S HEALTH
WITH THE GOAL OF ENSURING FUNDED
RESEARCH CONSIDERS WOMEN'S
HEALTH IN THE DEVELOPMENT OF
STUDY DESIGN AND IN DATA
COLLECTION AND ANALYSIS.
PRIORITIZING INVESTMENTS IN
WOMEN'S HEALTH RESEARCH.
THIS WILL FOCUS ON DRIVING
INNOVATION, INCLUDING THROUGH
ENTITIES LIKE ARPA-H, AND THE
SMALL BUSINESS INNOVATION
RESEARCH PROGRAM, WHILE
PROMOTING COLLABORATIVE
INTERDISCIPLINARY SCIENCE,
ADDRESSING HEALTH DISPARITIES
AND INEQUITIES AFFECTING WOMEN
AND SUPPORTS TRANSLATION OF
FINDINGS INTO IMPROVED HEALTH
OUTCOMES.
ALSO TO GALVANIZE RESEARCH ON
MID-LIFE HEALTH BY LAUNCHING A
COMPREHENSIVE RESEARCH AGENDA.
I THANK DR. BERTAGNOLLI FOR
MENTIONING MID-LIFE HEALTH,
WE'RE CONCERNED ABOUT DISORDERS
AND CONDITIONS THAT OFTEN OCCUR
IN MID-LIFE, INCLUDING SYMPTOMS
OF MENOPAUSE BUT INCLUDING AS
WELL INCREASED RISK AFTER
MENOPAUSE FOR HEART ATTACK,
ALZHEIMER'S DISEASE,
OSTEOPOROSIS AS EXAMPLES.
AND FINALLY TO ASSESS UNMET
NEEDS TO SUPPORT WOMEN'S HEALTH
RESEARCH.
AND WE DID THAT BY ASSESSING
GAPS IN FEDERAL FUNDING.
THIS IS GOING TO BE DONE BY
OFFICE OF MANAGEMENT AND BUDGET,
OMB.
AND GENDER POLICY COUNCIL.
THEY WILL BE IDENTIFYING CHANGES
PEOPLE ARE MAKING WITHIN
AGENCIES WITH REGARD TO WOMEN'S
HEALTH RESEARCH ON AN ANNUAL
BASIS.
ON THAT NOTE, AND I WANT TO TAKE
A STEP BACK AND TO SPEAK TO HOW
MEANINGFUL THIS WORK AND THE
FIRST LADY'S LEADERSHIP IS TO
THE FIELD OF WOMEN'S HEALTH
RESEARCH.
AS A CLINICIAN AND RESEARCHER,
AND THE FOUNDER AND DIRECTOR OF
A WOMEN'S HEALTH RESEARCH CENTER
AT YALE UNIVERSITY SCHOOL OF
MEDICINE, MY LIFE'S WORK REALLY
HAS BEEN DEDICATED TO WORKING ON
THE LARGE ISSUE OF IMPROVING THE
HEALTH OF WOMEN OVER TIME AND AS
I SAID EARLIER TO DID THAT IN
CONDITIONS THAT UNIQUELY AFFECT
WOMEN MORE PROMINENTLY OR AFFECT
WOMEN DIFFERENTLY.
AND IT IS MY CURRENT EXPERIENCE
THAT NEVER BEFORE HAS THERE BEEN
SUCH A COMPREHENSIVE EFFORT FROM
THE FEDERAL GOVERNMENT TO SPUR
INNOVATION IN WOMEN'S HEALTH,
RESEARCH, AND RELEVANT FEDERALLY
FUNDED HEALTH RESEARCH WORKING
HARDER FOR WOMEN.
THIS IS A HUGE OPPORTUNITY FOR
TRANSFORMATIVE CHANGE THAT CAN
IMPROVE THE HEALTH AND LIVES OF
WOMEN ACROSS THIS COUNTRY.
AND TO FULLY REALIZE THIS
OPPORTUNITY WE NEED TO WORK
TOGETHER ACROSS SECTORS AND
INDUSTRIES TO ENSURE ALL OF US,
GOVERNMENT, RESEARCH CENTERS,
ADVOCACY ORGANIZATIONS,
PHILANTHROPY AND PRIVATE SECTOR,
ARE DOING EVERYTHING WE CAN TO
CLOSE RESEARCH GAPS IN WOMEN'S
HEALTH.
THANKS TO THE FIRST LADY'S
LEADERSHIP, THE INITIATIVE WILL
CONTINUE TAKING ACTION TO
ADVANCE WOMEN'S HEALTH RESEARCH
SO WOMEN GET THE ANSWERS THEY
NEED WHEN IT COMES TO THEIR
HEALTH.
AND WITH THAT, I THANK YOU ALL
FOR YOUR TIME AND ATTENTION.
AND MOST OF ALL FOR YOUR CARING
ABOUT THE HEALTH OF WOMEN.
THANK YOU.
>> THAT THANK YOU FOR OUTLINING
THAT PATH FROM THE BEGINNING OF
THE SIGN OF THE PRESIDENTIAL
MEMO AND THAT 45-DAY SPRINT TO
COMMITMENT TO THE EXECUTIVE
AGENCIES THAT WE WOULD MAKE FOR
RECOMMENDATIONS TO THE ACTUAL
SIGNING OF THE EXECUTIVE ORDER.
>> I MIGHT INTERJECT, DR.
CLAYTON, THAT THE 45 DAYS WAS UP
ON DECEMBER 28.
WE DIDN'T MAKE A LOT OF FRIENDS
WITH THE AGENCIES HAVING THAT AS
THE DEADLINE, BUT THEY DID IT.
THEY WORKED WITH US.
WE WERE VERY PLEASED TO DO SO.
WE FOUND GREAT INTEREST AND
GREAT EXCITEMENT ON THE PART OF
THE AGENCIES.
AND WE ORGANIZED THAT MATERIAL
AND BRIEFED THE FIRST LADY ON
DECEMBER 29.
>> I KNOW HOW MUCH YOU RECEIVED
AT LEAST FROM THE DEPARTMENT OF
HEALTH AND HUMAN SERVICES, I CAN
NOT IMAGINE FROM ALL THE OTHER
DEPARTMENTS AND AGENCIES HOW
MUCH INFORMATION TO SYNTHESIZE
BUT I THINK THAT SPEAKS TO THE
COMMITMENT AS YOU SAID OF THE
FIRST LADY AND THE
ADMINISTRATION TO MOVING THIS
FORWARD.
I DO WONDER HOW RESEARCHERS AND
THE SCIENTIFIC COMMUNITY HAVE
REACTED TO THE GOALS OF THIS
WHITE HOUSE WOMEN'S HEALTH
RESEARCH INITIATIVE AS YOU'VE
BEEN TRAVELING THE COUNTRY AND
SPEAKING TO DIFFERENT GROUPS?
>> WELL, IT'S HARD TO CAPTURE
THE RIGHT WORDS TO DESCRIBE THE
EXCITEMENT ABOUT THIS AND
ENTHUSIASM FOR THIS.
BUT I WILL SAY A COUPLE THINGS,
IN ANSWER TO YOUR QUESTION.
ONE IS THAT THE GENDER POLICY
COUNCIL HAS BEEN IN EXISTENCE
SINCE MARCH OF 2021, AND THEY
HAVE DONE A VARIETY OF
INITIATIVES OVER THAT PERIOD OF
TIME.
THEY TOLD ME THAT THEY HAVE
NEVER SEEN ANYTHING QUITE LIKE
THIS.
THE OUTPOURING OF INTEREST,
SUPPORT, OPPORTUNITY, IS JUST
EXTRAORDINARY.
AND IN TALKING TO RESEARCHERS IN
PARTICULAR, AND EVEN TODAY WHEN
I HAD THE OPPORTUNITY TO TALK TO
MANY OF YOU, IT'S JUST REALLY
WONDERFULLY EXCITING FOR ME
PERSONALLY TO HEAR YOUR
EXCITEMENT ABOUT THIS, TO HEAR
THAT THINGS ARE GOING TO SHIFT
AND CHANGE, AND WE ARE REALLY
WORKING AS HARD AS WE CAN TO
SHOW THIS IS GOING TO CHANGE.
THAT WE'RE LOOKING FOR
SHORT-TERM MARKERS BUT IT TAKES
A LONG TIME, BUT IT CAN'T TAKE
AS LONG AS IT HAS IN THE PAST.
IT HAS TO MOVE FORWARD AS A MUCH
MORE RAPID PACE.
SO, WE WANT YOU TO JOIN WITH US
IN THAT EFFORT.
SO RESEARCHERS IN MY EXPERIENCE,
SIMPLY SAID, ARE OVER THE MOON.
>> YOU MENTIONED COMMON DATA
ELEMENTS, CAROLYN.
I WONDER IF YOU MIGHT SHARE YOUR
PERSPECTIVE ON POTENTIAL IMPACT
OF DEVELOPING NEW COMMON DATA
ELEMENTS THAT ARE SPECIFICALLY
DESIGNED WITH WOMEN IN MIND, THE
TOPIC CAME UP EARLIER, DR.
ANDERSON ASKED A QUESTION ABOUT
IT.
OF COURSE YOU HEARD FROM DR.
BERTAGNOLLI HOW IMPORTANT DATA
ELEMENTS CAN BE AS WE MOVE
FORWARD TO BE ABLE TO CONNECT
THOSE DOTS AND CREATE THAT
FEDERATED DATA SYSTEM THAT SHE
REFERENCED.
WHAT ARE YOUR THOUGHTS ON THE
POTENTIAL IMPACT OF SUCH?
>> THEY COULD HAVE A HUGE IMPACT
ON RESEARCH BECAUSE IF THEY ARE
DONE WELL, THEY PROVIDE THE
OPPORTUNITY TO CHARACTERIZE
VARIOUS STUDIES, VARIOUS
PARTICIPANTS, OTHER WAYS IN
WHICH WE WOULD UNDERSTAND ACROSS
THE FEDERAL GOVERNMENT WHO IS
FUNDING RESEARCH ON WHAT ASPECTS
OF WOMEN'S HEALTH.
AND THIS WOULD PROVIDE FOR
FURTHER EXAMINATION OF DATA, IT
COULD PROVIDE FOR META-ANALYSES
OF DATA.
I THINK IT WOULD OPEN UP A WHOLE
NEW AREA IN WHICH WE COULD LOOK
AT WELL-DONE RESEARCH BUT LOOK
AT IT IN A WIDER SCOPE.
SO I THINK IT'S REALLY A VERY
VALUABLE THING TO DO.
>> THE ANALYTIC APPROACHES AND
POSSIBILITIES DO SEEM REALLY
RICH AND ALMOST INFINITE IF WE
COULD ACTUALLY BE ABLE TO PUT
ALL OF THAT DATA TO WORK.
>> RIGHT.
>> SO I'M EXCITED ABOUT THAT AS
WELL.
ONE QUESTION THAT LOTS OF FOLKS
HAVE BEEN ASKING ME SO I'M GOING
TO ASK YOU, WHAT ARE THE NEXT
STEPS?
YOU OUTLINED THIS TASK FROM THE
PRESIDENTIAL MEMO TO AGENCY
COMMITMENT TO EXECUTIVE ORDER
AND NOW TO ACTIONS THAT WE'VE
TALKED ABOUT TAKING, DELINEATING
SEVERAL NIH ACTIONS, WHAT'S
NEXT?
>> A COUPLE THINGS REALLY
IMPORTANT IS FIRST WE HAVE TO
REALLY ENSURE THAT THE EXECUTIVE
ORDER, THE E.O. IS IMPLEMENTED.
I'VE SHOWN BROAD CATEGORIES BUT
THE SPECIFICITY UNDER EACH
CATEGORY IS GREAT.
AND IT RELATES BACK TO EACH
AGENCY.
SO, WE'RE GOING TO BE CONVENING
A WORKING GROUP THAT'S
CO-CHAIRED BY DR. JANINE CLAYTON
AND MYSELF, TO ENSURE THAT
THERE'S INTERAGENCY ALIGNMENT
ACROSS THESE INITIATIVES BECAUSE
WE DON'T WANT EVERYBODY DOING IT
DIFFERENTLY SO CAN YOU NOT LOOK
ACROSS ALL THESE AREAS, THESE
IMPORTANT AREAS.
PEOPLE HAVE MENTIONED OUTSIDE
THE NIH, CDC IS DOING IMPORTANT
WORK, SAMHSA IS DOING IMPORTANT
WORK, ALL OF THESE AGENCIES NOW
COULD WORK TOGETHER IN A MORE
UNIFORM WAY.
THAT'S ONE THING THAT WE'RE
DOING IN TERMS OF IMPLEMENTING
FURTHER WHAT'S GOING ON WITH THE
INITIATIVE ITSELF.
THE OTHER THING THAT'S REALLY
IMPORTANT IS WE'RE GOING TO
START WORKING DIRECTLY WITH
CONGRESS.
SO THAT WOULD MEAN BRIEFINGS TO
VARIOUS PEOPLE WHO HAVE NOW
ALREADY APPROACHED US, AND SAID
THIS IS SOMETHING OF INTEREST TO
US.
SO WE'VE BEEN TALKING TO PEOPLE,
ADVOCACY GROUPS WITHIN OUR HOME
DISTRICTS, CONCERNED ABOUT
ENDOMETRIOSIS OR CONCERNED ABOUT
OTHER DISEASES OR CONDITIONS
THAT WOMEN SUFFER
DISPROPORTIONATELY.
IT'S ALL SORTS OF THINGS THAT
ARE COMING IN TO US OF
EXPRESSIONS OF INTEREST ABOUT
PARTICULAR AREAS.
AND SO WE WANT TO GO TO CONGRESS
AND TALK WITH THEM ABOUT THAT SO
THEY KNOW THAT THEY ARE OUT OF
THEIR HOME DISTRICTS, PEOPLE
WANT TO SEE THIS MOVE FORWARD
AND HELP US THINK ABOUT
CHAMPIONS FROM BOTH SIDES OF THE
AISLE WHO THINK THIS IS
IMPORTANT.
HISTORICALLY IN THE CONGRESS,
THERE HAS BEEN THE CAPACITY TO
MAKE COMMONLY ADVANTAGEOUS
DECISIONS ON EDUCATION AND
HEALTH.
AND WE'RE HOPING THAT THAT STILL
EXISTS TODAY TO SOME DEGREE,
PEOPLE CAN GET TOGETHER ON THE
HEALTH OF THE NATION BECAUSE WE
DO KNOW AND THERE ARE DATA TO
INDICATE AS WOMEN'S HEALTH
IMPROVES, FAMILIES IMPROVE, AND
THE SOCIETY IMPROVES, AND
ECONOMICALLY THERE'S
IMPROVEMENT.
SO, ALL OF THIS IS VERY TIED
TOGETHER FOR US AND FOR THE
PRESIDENT AND FIRST LADY, AND
CONSIDER THIS A HOLISTIC PICTURE
WHICH IS PART OF WHY IN ADDITION
TO THE MONIES THAT WE'RE TALKING
ABOUT HERE THERE'S A REAL
EQUIPMENT I THINK TO IMPROVING
THE HEALTH OF THE NATION IN A
WAY THAT REALLY DESERVES OUR
ATTENTION.
>> WE APPRECIATE YOU BEING HERE
AND SHARING THIS UNIQUE
PERSPECTIVE, LOOKING FORWARD TO
CONTINUING TO WORKING WITH YOU
ACROSS THE AGENCIES ON THESE
IMPORTANT ENDEAVORS.
I LIKE WHAT YOU SAID ABOUT
ENHANCING COORDINATION AND
ENSURING THAT'S IN HARMONY SO WE
CAN ACTUALLY ACCELERATE
PROGRESS.
YOU USE THAT WORD, ACCELERATE,
IN ONE OF YOUR SLIDES.
WE'VE MADE SUBSTANTIAL
INVESTMENTS, WE'VE LEARNED SO
MUCH BUT THERE ARE GAPS IN OUR
KNOWLEDGE THAT AFFECT OUR
ABILITY TO DELIVER
EVIDENCE-BASED CARE TO WOMEN.
I APPRECIATE THE FOCUS ON
MID-LIFE HEALTH AS WELL.
THANK YOU AGAIN.
YOU MENTIONED, CAROLYN, THAT
THERE WOULD BE A PLACE WHERE
SOMEBODY COULD GET INFORMATION.
YOU MENTIONED FACTSHEETS.
WHITE HOUSE FACTSHEETS.
>> YES, THE FACTSHEETS, SO FIRST
OF ALL IF YOU GO TO THE
WHITEHOUSE.GOV WEBSITE YOU CAN
GO IN THERE AND YOU CAN PULL OUT
THIS INFORMATION.
THERE'S ALSO ON THE LAST SLIDE I
GAVE A PARTICULAR E-MAIL
ADDRESS, AND IF YOU HAVE
QUESTIONS YOU CAN WRITE TO THAT
OR IF YOU WANT TO BE ON OUR
MAILING LIST BECAUSE WHEN THING
COME OUT WE THINK ARE WORTHY OF
YOUR ATTENTION IN YOUR BUSY DAY,
SO YOU'RE NOT GOING TO GET ONE
EVERY WEEK, YOU'LL GET SOMETHING
FROM US ABOUT WHAT THE LATEST
INFORMATION IS.
AND SO WE'RE VERY -- I THINK
THIS ADMINISTRATION, THIS
EFFORT, IS VERY ENGAGED WITH THE
PUBLIC.
AND WANTS TO HEAR FROM PEOPLE
AND WANTS US TO ALL WORK
TOGETHER TO GET THIS DONE.
>> THANK YOU.
PLEASE JOIN ME IN THANKING DR.
CAROLYN MAZURE.
>> THANK YOU.
WE'RE A FEW MINUTES EARLY.
I WOULD FIRST OF ALL LIKE TO
INVITE OUR NEXT PANELISTS.
WE'RE DOING A TRANSITION.
I WOULD LIKE DR. BRINTON, DR.
BURNETT-BOWIE AND DR. HODIS TO
GO TO THE FRONT AS WELL AS ALSO
DR. CHHANDA DUTTA.
DON'T WALK AWAY BECAUSE WE'RE
GOING TO START ON TIME.
LET ME TALK ABOUT DR. DUTTA
MODERATING THE NEXT PANEL,
FOCUSING ON MIDDLE LIFE HEALTH
OF WOMEN AND MENOPAUSE.
CURRENTLY THE CHIEF OF THE
CLINICAL GERONTOLOGY BRANCH,
DIVISION OF GERIATRICS AND
CLINICAL GERONTOLOGY OF THE
NATIONAL INSTITUTES OF AGING.
DURING HER TENURE AT NIH, SHE
HAS OVERSEEN RESEARCH ON AGING
OF THE MUSCULOSKELETAL SYSTEM,
SARCOPENIA, INCONTINENCE,
NUTRITION AND METABOLISM TO NAME
A FEW, SUPPORTING RESEARCH ON
AGING ACROSS THE LIFESPAN.
FOR EXAMPLE, AREAS SUCH AS
INFLUENCE OF EARLY AND MID-LIFE
CHANGES ON HEALTH ON LATER LIFE
HEALTH, IMPACT OF THE MENOPAUSAL
TRANSITION ON LATER LIFE HEALTH,
STUDIES IN HUMAN LONGEVITY AND
HEALTHY AGING, NOT ONLY FROM THE
GENOMIC AND OTHER FACTORS BUT
ALSO REALLY PUTTING IT INTO THE
TRANSLATIONAL FOCUS OF CLINICAL
ISSUES AROUND AGING RESEARCH.
SO I'M GOING TO TURN IT OVER TO
YOU, DR. DUTTA, AND THE PANEL.
>> THANK YOU, DR. CLAYTON AND
DR. OTA WANG FOR THIS INVITATION
TO MODERATE THIS NEXT PANEL.
IT'S MY GREAT PLEASURE TO
INTRODUCE OUR STELLAR PANEL OF
SPEAKERS.
THEY INCLUDE DR. ROBERTA DIAZ
BRINTON, DR. SHERRI ANN
BURNETT-BOWIE, DR. HOWARD HODIS.
DR. BRINTON IS AT UNIVERSITY OF
ARIZONA, DEVOTED TO DEVELOPING
THERAPEUTICS FOR AGE-ASSOCIATED
NEURODEGENERATIVE DISEASES
INCLUDING ALZHEIMER'S,
PARKINSON'S, MULTIPLE SCLEROSIS
AND ALS.
SHE HAS AUTHORED MORE THAN 250
SCIENTIFIC PUBLICATIONS, HOLDS
MULTIPLE PATENTS, FOUNDED TWO
BIOTECH STARTUPS, MOST RECENTLY
NEW THERAPEUTICS.
SHE'S AN INTERNATIONALLY
RECOGNIZED EXPERT ON A.D.,
DISCOVERIES HAVE LED TO
INNOVATIVE THERAPEUTICS TO
PREVENT, DELAY, TREAT A.D.,
CONDUCTED TWO PHASE IIA CLINICAL
TRIALS, AND IS CURRENTLY
CONDUCTING THREE PHASE 2B
INCLUDING ALLOPREGNANOLONE TO
REGENERATE THE BRAIN AND
CLINICAL TRIALS TO DETERMINE
SAFETY AND EFFICACY TO PROMOTE
BRAIN GLUCOSE METABOLISM,
COGNITION, ALLEVIATE MENOPAUSAL
SYMPTOMS.
DR. BRINTON'S SERVICE INCLUDE
SERVING ON NIH DIRECTOR'S
ADVISORY COMMITTEE, NIA
SCIENTIFIC ADVISORY BOARD, AND
ALZHEIMER'S DISEASE DRUG
DISCOVERY FOUNDATION BOARD OF
GOVERNORS.
SIGN
SCIENTIST OF THE YEAR FROM
ALZHEIMER'S FOUNDATION, ARIZONA
BIOSCIENCE RESEARCHER OF THE
YEAR, U.S. PRECEDENTIAL CITIZENS
MEDAL, HIGHEST CIVILIAN HONOR
FOR STEM EDUCATION TO ADVANCE
UNDERREPRESENTED DISCOVERIES.
SECOND SPEAKER DR.
BURNETT-BOWIE, ADULT
ENDOCRINOLOGIST, SPECIALIZING IN
OSTEOPOROSIS AT MASS GENERAL,
ASSOCIATE PROFESSOR OF MEDICINE
AT HARVARD MEDICAL SCHOOL,
INVESTIGATION FOCUSES ON
MENOPAUSE AND AGING,
EPIDEMIOLOGY, TREATMENTS FOR
OSTEOPOROSIS, PHOSPHATE AND
VITAMIN D PHYSIOLOGY, PRINCIPAL
INVESTIGATOR FOR THE STUDY OF
WOMEN'S HEALTH ACROSS THE
NATION, 25-YEAR STUDY WHICH HAS
TRANSFORMED OUR UNDERSTANDING OF
THE TRANSITION ON A VARIETY OF
HEALTH OUTCOMES.
I SHOULD ADD AS THE PROGRAM
OFFICER FOR THE SWAN STUDY, IT'S
MY PLEASURE TO HAVE WORKED WITH
DR. BURNETT-BOWIE.
IN ADDITION CO-CHAIRED AMERICAN
SOCIETY FOR BONE AND MINERAL
RESEARCH TASK FORCE ON CLINICAL
ALGORITHMS FOR FRACTURE RISK,
WHICH INVESTIGATED USE OF RACE
AND ETHNICITY IN THE WIDELY USE
FRACTURE RISK ASSESSMENT TOOL
OTHERWISE KNOWN AS FRAX.
SHE'S NATIONALLY RECOGNIZED FOR
INNOVATIONS AND CARING FOR
PATIENTS WITH MINERAL DISORDERS
DEFINING BIAS IN PATIENT CARE
AND EDUCATION AND HER TEACHING
AND MENTORSHIP.
DR. BURNETT-BOWIE ONGOING GOALS
INCLUDE CONTINUED DEVELOPMENT OF
INNOVATIVE APPROACHES FOR
ADDRESSING DISPARITIES IN
OSTEOPOROSIS CARE AND IMPROVING
HEALTH OF WOMEN AT MID-LIFE AND
OLDER ADULTHOOD.
OUR THIRD SPEAKER IS DR. HOWARD
HODIS, OVERARCHING RESEARCH
INTERESTS HAVE BEEN IN THE FIELD
OF VASCULAR DISEASE AND
ATHEROBIOLOGY WITH PURSUITS TO
UNDERSTAND GENETICS AND BIOLOGY
AND ETIOLOGY AND PROGRESSION
INCLUDING PREVENTION AND
INTERVENTION.
HIS RESEARCH INTERESTS ALSO
INCLUDE DEVELOPMENT AND
APPLICATION OF IMAGING AND
MEASUREMENT TOOLS FOR THE
ASSESSMENT, SCREENING,
PREVENTION AND TREATMENT OF
ATHEROSCLEROSIS AND
CARDIOVASCULAR DISEASE, SPANS
BASIC TO CLINICAL SCIENCE
INCLUDING LARGE POPULATION
STUDIES AND INTERVENTION TRIALS.
WITH 30 YEARS OF CONTINUOUS NIH
FUNDING, DR. HODIS AS EXTENSIVE
EXPERIENCE AS PRINCIPAL
INVESTIGATOR FROM 22 NIH
PROJECTS INCLUDING EIGHT LARGE
RANDOMIZED TRIALS INTEGRATING
TRANSLATIONAL RESEARCH,
BIOMEDICAL ENGINEERING,
INTEGRATIVE BIOLOGY, SPANS BASIC
CLINICAL AND GENETIC
INVESTIGATION.
IN ADDITION HE HAS AN EXTENSIVE
COLLABORATIVE RECORD AS CO-P.I.
ON OTHER 30 NIH FEDERALLY FUNDED
PROJECTS.
AS THE DIRECTOR OF THE UNIT CORE
IMAGING AND RESEARCH READING
CENTER, HAS 30 YEARS OF
EXPERIENCE IN LEADING A STABLE
TEAM OF HIGHLY TRAINED AND
EXPERIENCED IMAGING SPECIALISTS
IN THE COORDINATION AND CONDUCT
OF 25 HUMAN CLINICAL STUDIES
PREDOMINANTLY NIH FUNDED AND
HAVE INCLUDED LARGE NATIONAL
TRIALS IN EPIDEMIOLOGIC STUDIES,
PROVIDING ARTERIAL IMAGING
SERVICES ENCOMPASSING ANATOMICAL
AND PHYSIOLOGICAL MEASUREMENTS
OF ATHEROSCLEROSIS PROVIDING A
FULL ARRAY OF RESEARCH AND
EXPERIENCE CAPABILITIES.
DR. HODIS HAS RECEIVED A NUMBER
OF HONORS AND AWARDS INCLUDING
NORTH AMERICAN MENOPAUSE SOCIETY
THOMAS CLARKSON OUTSTANDING
CLINICAL AND BASIC SCIENCE
RESEARCH AWARD, PEER-NOMINATED
AWARD FOR TRANSLATIONAL
CONTRIBUTIONS.
ALSO RECEIVED NASA TECHNOLOGY
AWARD, AND OUTSTANDING TEACHING
AWARD FROM UNIVERSITY OF
SOUTHERN CALIFORNIA.
HE HAS BEEN INDUCTED INTO THE
PRESTIGIOUS ASSOCIATION OF
AMERICAN PHYSICIANS AND HOLDS
MEMBERSHIP IN A VARIETY OF
SCIENTIFIC ORGANIZATIONS, SUCH
AS FELLOW OF THE AMERICAN HEART
ASSOCIATION.
HE SERVES ON SPECIAL EMPHASIS
PANELS FOR NIH AND REVIEW
COMMITTEES AND AS WELL AS OTHER
FUNDING AGENCIES.
DR. HODIS HAS DELIVERED MORE
THAN 325 INVITED PRESENTATIONS
WORLDWIDE, AUTHORED OR
CO-AUTHORED MORE THAN 275
ORIGINAL SCIENTIFIC
PEER-REVIEWED PUBLICATIONS.
PLEASE JOIN ME IN WELCOMING
THESE EXCELLENT SPEAKERS.
>> PLEASE HOLD YOUR QUESTIONS
UNTIL THE MODERATED Q&A SESSION
FOLLOWING THE THREE
PRESENTATIONS.
AND WITH THAT, I WILL INTRODUCE
DR. BRINTON.
>> THANK YOU.
THANK YOU ESPECIALLY TO DR.
CLAYTON AND OTA WANG FOR THE
INVITATION TO SHARE OUR
SCIENTIFIC JOURNEY OVER MANY
YEARS FUNDED BY THE NIA AND
WOMEN'S HEALTH, FROM MECHANISTIC
DISCOVERY TO DETERMINING WHETHER
OUR BASIC SCIENCE DISCOVERIES
TRANSLATE TO HUMAN BRAIN THROUGH
HUMAN BRAIN IMAGING TO
POPULATION DATA SCIENCE, AND
ULTIMATELY NOW THE CLINICAL
TRIALS.
SO, JUST A QUICK QUESTION.
IS THERE A POINTER?
THE TOP BUTTON?
GREAT!
LOVE IT.
THANK YOU SO MUCH.
AGAIN, IT'S A GREAT HONOR TO BE
WITH YOU AT THE 60th ADVISORY
COMMITTEE ON RESEARCH ON WOMEN'S
HEALTH.
SO, ALL RIGHT.
I'M PRESSING THIS BUTTON, MIDDLE
BUTTON.
THESE ARE MY DISCLOSURES, AND
GOING FORWARD, THERE WE GO.
SO, I ACTUALLY STARTED THIS
JOURNEY INTO ALZHEIMER'S DISEASE
BECAUSE OF ONE WOMAN WHO
TRANSFORMED MY SCIENTIFIC CREEK,
ONE WOMAN WITH ALZHEIMER'S.
IT LED ME TO BEGIN TO ASK THE
QUESTION, WHY WOMEN ARE AT A
TWO-FOLD GREATER RISK FOR
DEVELOPING ALZHEIMER'S DISEASE
AND TYPICALLY THE THOUGHT WAS
IT'S BECAUSE WOMEN LIVE ON
AVERAGE 4.5 YEARS LONGER THAN
MEN.
AND WHAT OUR RESEARCH I'LL GIVE
YOU THE CLIFF NOTES VERSION, OUR
RESEARCH HAS SHOWN THAT THE
RATIONALE FOR OUR DISCOVERY
SCIENCE, THE AVERAGE AGE OF
DIAGNOSIS FOR ALZHEIMER'S
DISEASE IS 70 TO 75, WE KNOW
THERE'S A 20-YEAR PRODROMAL
PHASE, AND DOING THAT MATH YOU
RUN INTO THE MENOPAUSAL
TRANSITION.
AND IT WAS THAT DISCOVERY, NOT
THAT DISCOVERY BUT THAT
RECOGNITION THAT BEGAN THIS
JOURNEY OF TRYING TO UNDERSTAND
HOW THE BRAIN IS CHANGING DURING
THIS MENOPAUSAL TRANSITION AND
THE OUTCOMES OF THAT RESEARCH
SHOW IT'S WOMEN AT GREATER RISK
FOR DEVELOPING ALZHEIMER'S
DISEASE NOT BECAUSE THEY LIVE
LONGER, BUT BECAUSE THE DISEASE
CAN START EARLIER.
SO LET'S TAKE A LOOK AT THAT
PROCESS.
WHEN WE LOOK AT THE MENOPAUSAL
TRANSITION, MENOPAUSE IS LIKE
PUBERTY, A TRANSITION STATE.
WHAT WE FIND IS THAT THERE IS
THE BEGINNING OF A DECLINING
BRAIN GLUCOSE METABOLISM IN RED,
AND A RISE IN VARIABILITY OF
NEUROLOGICAL FUNCTION THAT
STABLEs TO ANOTHER STAKE IN
THE MENOPAUSE.
ONE OF THOSE MENOPAUSAL
SYMPTOMS, PRIMARILY HOT FLASHES,
AND OF THE 80% OF WOMEN
SYMPTOMATIC, THE PRIMARY SYMPTOM
IS HOT FLASHES, AND IT CAN
INCLUDE COGNITIVE DYSFUNCTION,
PLUS INSOMNIA, PLUS MOOD
CHANGES, AND FOR SOME WOMEN
DEPRESSION AND IN SOME INSTANCES
SUICIDAL IDEATION, AND OBVIOUSLY
COMBINATION OF THE THREE.
SO NONE OF THESE SYMPTOMS HAVE
ANYTHING TO DO, INCLUDING THE
HOT FLASH, HAVE ANYTHING TO DO
WITH MENOPAUSE PER SE, BUT WITH
THE CHANGES THAT ARE OCCURRING
IN THE BRAIN.
SO, WHEN WE BEGAN TO ASK WHY
THAT WAS THE CASE WE HAD TO
STUDY ESTROGEN.
I CALL ESTROGEN THE QUEEN OF
DARWIN.
SHE HAS LEFT NOTHING TO CHANCE.
AND PART OF THAT IS REGULATING
GLUCOSE METABOLISM IN THE BRAIN.
THE BRAIN IS AN ALMOST
EXCLUSIVELY GLUCOSE DEPENDENT
ORGAN AND IS ESTROGEN REGULATES
20 TO 25% FROM GLUCOSE UPTAKE TO
GLUCOSE METABOLISM, ULTIMATELY
ATP GENERATION.
LOSS OF ESTROGEN IN TRANSITION
CAN BE ASSOCIATED WITH AN
ACTIVATION OF A STARVATION
RESPONSE.
THAT STARVATION RESPONSE ASKS
THE BRAIN TO FIND AN ALTERNATIVE
AUXILIARY FUEL IN ADDITION TO
GLUCOSE METABOLISM.
AND WE BEGAN TO ASK, THIS IS
DECADES OF BASIC SCIENCE
RESEARCH, AGAIN I WANT TO
EMPHASIZE THAT OUR RESEARCH HAS
BEEN SUPPORTED BY THE NATIONAL
INSTITUTE ON AGING FOR MORE THAN
A DECADE NOW, THEY WERE LEADERS
IN THE FIELD OF WOMEN'S HEALTH.
BRAIN HEALTH.
AND ESSENTIALLY WHAT WE FIND
THIS ACTIVATION OF A STARVATION
RESPONSE ENABLES THE BRAIN TO
USE KETONE BODIES, GOOD NEWS,
BAD NEWS.
THE BAD NEWS IS -- SORRY, I
SKIPPET OVER.
I HOPE I SKIPPED OVER A SLIDE.
I DON'T KNOW WHERE THAT SLIDE
IS.
BUT FOR US WE ASKED THE
QUESTION, WHERE IS THE BRAIN
ACQUIRING KETONE BODIES?
AND WHAT WE FOUND IS THAT THE
BRAIN CAN UTILIZE ITS OWN SOURCE
OF LIPIDS, THE WHITE MATTER OF
THE BRAIN.
AND WHAT WE FIND IS THAT DURING
THIS MENOPAUSAL TRANSITION, WE
FIND THAT THERE'S A METABOLIC
REPROGRAMMING IN MID-LIFE IN THE
MID-LIFE FEMALE BRAIN WHERE
THERE'S THE DECLINE OF GLUCOSE
METABOLISM IN THE BRAIN, AND A
RISE, EARLY RESPONSE TO UTILIZE
AMINO ACIDS, SHORT-LIVED, AT THE
COST EVER SYNAPTIC NEURAL
CIRCUIT DEVELOPMENT IN THE
BRAIN, UTILIZATION OF THOSE
AMINO ACIDS.
AND THEN WHAT WE FIND IS THAT
THERE'S A RISE, SIGNATURE, A
RISE OF FATTY ACID METABOLISM IN
THE BRAIN.
THAT'S ASSOCIATED WITH A CHANGE
IN MITOCHONDRIAL PHENOTYPE FROM
ESTROGENIC PROFILE OF HIGHLY
EFFICIENT MITOCHONDRIA THAT IS
DEPENDENT UTILIZATION OF GLUCOSE
TO NOW THE METABOLISM OF FATTY
ACIDS AND BETA OXIDATION, AND
THAT IS ASSOCIATED WITH
INEFFICIENT MITOCHONDRIA, AND
THAT IS PARALLELED BY A RISE IN
KETONE BODIES.
NOW ESSENTIALLY ADAPT TO THIS
REDUCTION IN GLUCOSE METABOLISM.
SO, WHAT IS THE SOURCE OF THE
KETONE BODIES TO FUEL A STARVING
BRAIN?
THE BRAIN IS THE MOST LIPIDDATED
JOGGER BEGAN OF THE BODY, 60% OF
BRAIN WEIGHT IS WHITE MATTER
OTHER LIPID WEIGHT.
THIS IS THE SOURCE OF THE KETONE
BODIES THAT ARE BEING GENERATED
IN THE BRAIN.
THIS IS A RATHER SHORT VERSION
OF MANY DECADES OF RESEARCH
MECHANISTIC RESEARCH, AND WHAT
WE FIND IS THAT AS I MENTIONED
NEURONS SEND OUT STARVATION
RESPONSE, ASTROCYTES NOW BEGIN
TO RESPOND TO THAT STARVATION BY
GENERATING KETONE BODIES THROUGH
BETA OXIDATION, WHERE ARE THEY
GETTING THAT FUEL?
AGAIN, THE WHITE MATTER.
AND THE WHITE MATTER NOW IS THE
SOURCE OF THE LIPIDS THAT WILL
BE ULTIMATELY METABOLIZED INTO
KETONE BODIES.
THE CHALLENGING NEWS IS THAT
THROUGH THE CATABOLISM OF WHITE
MATTER, MYELIN DEBRIS IS
GENERATED, BRINGING IN THE
MICROGLIA OF THE BRAIN, THESE
MYELIN DEBRIS IS TAKEN UP BY THE
MICROGLIA, AND THOSE FRAGMENTS
ARE THEN PRESENTED ON THE PLASMA
MEMBRANE OF THE MICROGLIA, AND
WHEN WE LOOK AT THIS RESPONSE
WHAT WE SEE IS CONSISTENT WITH
AN AUTOIMMUNE RESPONSE THAT IS
OCCURRING IN THE BRAIN DURING
THIS MENOPAUSAL TRANSITION, TO
THE BRAIN'S OWN WHITE MATTER.
NOW WHEN WE THINK ABOUT MULTIPLE
SCLEROSIS AS A RISK FACTOR, 95%
OF ALL PEOPLE WHO DEVELOP
MULTIPLE SCLEROSIS PAST 50 ARE
FEMALE.
SO, IN THE COURSE OF THIS, OF
PROGRAM OF RESEARCH, I TALKED
ABOUT THE CHANGE, REPROGRAMMING,
METABOLIC REPROGRAMMING THAT
GOES ON.
AND THE ACTIVATION OF IMMUNE
RESPONSE.
WHAT THAT REALLY LOOKS LIKE IS
THIS.
WE SEE FIRST ACTIVATION OF
INNATE IMMUNE SYSTEM.
FOLLOWED BY THE DECLINE IN
GLUCOSE METABOLISM SO THIS
ACTIVATION OF THE INNATE IMMUNE
SYSTEM HAPPENS IN THE EARLY
CHRONOLOGICAL AGING PRIOR TO END
CHRONOLOGICAL AGING.
THE DECLINE IN GLUCOSE
METABOLISM LEADS TO THIS
COMPENSATORY RESPONSE TO UTILIZE
BRANCHED AMINO ACIDS THAT ENABLE
GENERATION OF BOTH CONVERSION OF
BRANCHED AMINO ACIDS INTO
GLUCOSE OR KETONE BODIES,
SHORT-LIVED, WHILE THE SECOND
SYSTEM COMES ON AND DECLINE IN
THE MITOCHONDRIAL EFFICIENCY,
AND THE RISE IN THE FATTY ACID
BETA OXIDATION, ULTIMATELY THE
GENERATION OF KETONE BODIES.
OKAY.
SO, NOW WHAT WE SEE IS THAT
THERE ARE ACTUALLY THREE
PROGRAMS, TWO PROGRAMS,
METABOLIC REPROGRAMMING AND
IMMUNE ACTIVATION, THAT ARE
OCCURRING DURING THIS PROCESS
WHICH IS QUITE COMPLEX.
AND FINALLY, WE HAVE ACTIVATION
OF THE ADAPTIVE IMMUNE SYSTEM.
EACH OF THESE SYSTEMS ARE
CONSISTENT WITH A PROFILE IN
ALZHEIMER'S DISEASE.
WE ALSO FIND THAT IN FACT THE
HOT FLASH IS LIKELY DUE TO THE
ACTIVATION OF THE MICROGLIA, AND
THE MICROGLIA ACT AS THESE
NEUTROPHILS IN THE BRAIN, WHERE
THEY HAVE BURST OF RESPIRATORY
BURST TO ESSENTIALLY DESTROY A
FOREIGN BODY, THAT FOREIGN BODY
THOUGH TENDS TO BE MYELIN
DEBRIS.
SO, OUR BASIC SCIENCE RESEARCH
REALLY HAS INDICATED THAT THE
HOT FLASH IS REALLY BECAUSE OF
THE INEFFICIENT MITOCHONDRIA AND
NOW THERE'S PROTON LEAK WITHIN
THE BRAIN THAT'S GENERATING HEAT
WITHIN THE BRAIN.
AND THAT IS ASSOCIATED WITH
WHITE MATTER LOSS.
SO, IS THERE EVIDENCE FOR
METABOLIC REPROGRAMMING IN THE
HUMAN BRAIN, THE RESEARCH I
SHOWED IS OUR BASIC SCIENCE
DISCOVERY RESEARCH AND THIS IS
WORK WE CONDUCTED WITH LISA
MOSSCONI IN THE BRAIN AGING FROM
NIA.
WE FIND THAT IN, YES, CONSISTENT
WITH OUR DISCOVERY DATA, WE FIND
THAT THERE IS DECLINING GLUCOSE
METABOLISM IN TEMPORAL CORTEX,
PRECUNEUS AND FRONT CORTEX, ALL
INVOLVED IN ALZHEIMER'S DISEASE.
WHEN WE LOOK AT CHANGES BY MRI
IN BRAIN STRUCTURE THERE'S
AGE-ASSOCIATED DIFFERENCES IN
THE GRAY MATTER VOLUMES RELATIVE
TO THE AGING MALE BRAIN BUT
WHERE THE REAL CHANGES OCCUR ARE
IN THE WHITE MATTER WHICH IS
CONSISTENT WITH THE METABOLOMIC
PROFILE OF THE FEMALE INDIVIDUAL
WITH ALZHEIMER'S DISEASE.
WE THEN ASK THE QUESTION, IF
THIS CHANGE IN GLUCOSE
METABOLISM AND CHANGE IN WHITE
MATTER VOLUME IS ASSOCIATED WITH
DEPOSITION OF A CLASSIC
PATHOLOGY HALLMARK OF
ALZHEIMER'S DISEASE WE FIND
INDEED IT IS, THAT THERE'S
DEPOSITION OF BETA AMYLOID
PLAQUE IN THE BRAIN, COINCIDENT
WITH DECLINE IN GLUCOSE
METABOLISM AND WHITE MATTER
LOSS.
IF LOSS OF ESTROGEN INITIATES
MID-LIFE TRAJECTORY OF
VULNERABILITY, DOES MENOPAUSAL
HORMONE THERAPY IMPACT THE RISK
OF ALZHEIMER'S DISEASE?
CAN WE REPLACE THAT ESTROGEN
THERAPEUTICALLY?
AND THIS IS DATA SCIENCE WORK
FROM OUR TEAM THAT INVESTIGATED
THE IMPACT OF MENOPAUSAL HORMONE
THERAPY ON RISK OF DEVELOPING
MULTIPLE AGE-ASSOCIATED
NEURODEGENERATIVE DISEASES, AND
WE FIND INDEED THERE IS A NEAR
50% OR GREATER REDUCED RISK IN
DEVELOPING AGE-ASSOCIATED
NEURODEGENERATIVE DISEASES WITH
MENOPAUSAL HORMONE THERAPY, THE
LONGER WOMEN USE MENOPAUSAL
HORMONE THERAPY THE GREATER THE
REDUCTION IN RISK.
AND THIS WAS DONE IN ABOUT
380,000 WOMEN IN THE DATASET.
NOW, THIS BRINGS UP THE
QUESTION, BECAUSE THERE'S A LOT
OF CONTROVERSY AROUND MENOPAUSAL
HORMONE THERAPY.
SO, IT IS TYPICALLY GIVEN FOR
MENOPAUSAL SYMPTOMS.
AT THE AGE WHEN WOMEN EXPERIENCE
MENOPAUSAL SYMPTOMS.
HOWEVER, AT THIS POINT, THE
FIRST RX TREATMENT POINT HERE,
IS THAT GOING TO BE BENEFICIAL
OR DELETERIOUS OR OF NO IMPACT
DURING THE SECOND PART, OR LATE
ENDOCRINOLOGICAL TRANSITION.
SYMPTOMS IN PROCESS IN THE BRAIN
ARE QUITE DIFFERENT BASED ON
THIS AGING PROFILE, THE EARLY
ENDO, AND LATE PERIODS OF AGING.
THIS MAY IN FACT BE ONE OF THE
REASONS WHY THERE'S SO MUCH
CONTROVERSY AROUND MENOPAUSAL
HORMONE THERAPY AND THE
OUTCOMES.
WE THEN ASK IF ESTROGEN IS
BENEFICIAL FOR THE BRAINY DO 80%
OF WOMEN ELECT NOT TO RECEIVE
HORMONE THERAPY FOR MENOPAUSAL
SYMPTOMS?
THE SIMPLE ANSWER IS FEAR OF
BREAST CANCER.
SO IN ORDER TO PROMOTE BRAIN
HEALTH WE HAVE TO CONSIDER
BREAST HEALTH.
WE DEVELOPED A NUTRICEUTICAL
INTERVENTION, WE LEARNED FROM
WOMEN THAT THEY ARE GOING TO
OVER THE COUNTER PRODUCTS TO
TREAT, TO MANAGE THEIR
MENOPAUSAL SYMPTOMS, REGARDLESS
OF WHETHER THAT PRODUCT IS
EFFECTIVE OR SAFE.
WE DEVELOPED AN INTERVENTION,
PHYTO SERUM, THAT TARGETS
ESTROGEN RECEPTOR BETA IN THE
BRAIN.
NOW, ESTROGEN RECEPTOR BETA
WE'VE DONE DECADES OF RESEARCH
AND DEMONSTRATED IT IS A VERY
EFFECTIVE ESTROGEN RECEPTOR IN
THE BRAIN TO PROMOTE GLUCOSE
METABOLISM, REDUCE INFLAMMATION,
SUSTAIN ESTROGEN ACTION IN THE
BRAIN.
IT'S IMPORTANT BECAUSE FROM OUR
COLLEAGUES IN THE CANCER FIELD
WE LEARNED THAT ESTROGEN
RECEPTOR BETA IS ACTUALLY
ASSOCIATED WITH INHIBITION OF
BREAST CANCER DEVELOPMENT,
PROLIFERATION OF NORMAL BREAST
TISSUE, OF BREAST CANCER CELL
PROLIFERATION AND INHIBITS
BREAST CANCER CELL MIGRATION AND
INVASION.
WE HAVE THROUGH NIA FUNDING
CONDUCTED A PHASE 1B 2A CLINICAL
TRIAL OF A FORMULATION OF THREE
PLANT-BASED MOLECULES THAT
ACTIVATE, HAVE 80% SELECTIVITY
FOR ESTROGEN RECEPTOR BETA, AND
CONDUCTED THOSE ANALYSES AND
DETERMINED BOTH SAFETY AND
OPTIMAL DOSING AND SAW AN
INITIAL RESPONDER SET.
WE'RE NOW CONDUCTING TWO PHASE 2
CLINICAL TRIALS, THIS GIVES A
PROFILE OF THE WORK WE'VE
COMPLETED.
WE SHALL NOW CONDUCTING TWO
PHASE 2 CLINICAL TRIALS, ONE
TARGETING THE DECLINE IN BRAIN
GLUCOSE METABOLISM TO DETERMINE
WHETHER PHYTO SERUM PREVENT, IF
IT SUSTAINS GLUCOSE METABOLISM
THAT WOULD PUT THE BRAIN ON A
PATH TO SUSTAIN ITS WHITE MATTER
INTEGRITY AND POTENTIALLY
ULTIMATELY INHIBIT OR PREVENT
ARIZONA DISEASE.
AND OUR SECOND CLINICAL TRIAL HF
RELIEF IS TARGETING MENOPAUSAL
HOT FLASHES TO SUSTAIN BRAIN AND
BREAST HEALTH.
WITH THAT I WILL FINISH WITH KEY
CONCEPTS THAT THE MENOPAUSE IS
ACTUALLY A NEUROLOGICAL
TRANSITION, THIS TRANSITION
INVOLVES BOTH METABOLIC AND
IMMUNE SYSTEM REPROGRAMMING, AND
THAT MENOPAUSAL HORMONE THERAPY
PROMOTES HEALTHY BRAIN AGING,
DOES NOT REVERSE DISEASE.
THAT PROMOTING BRAIN AN BREAST
HEALTH IS FEASIBLE THROUGH
FORMULATION.
GAPS AND OPPORTUNITIES IS
PRECISION MENOPAUSAL THERAPY,
WHAT'S THE RIGHT THERAPY,
INTERVENTION, FOR THE RIGHT
WOMAN AT THE RIGHT TIME.
BIOMARKERS, DEVELOPING
BIOMARKERS OF TRANSITION STAGE
BEYOND CLINICAL SYMPTOMS BUT CAN
WE IDENTIFY WOMEN EARLY IN THIS
PROCESS?
AND WITH THAT I WILL END AND
GIVE RECOGNITION TO THE TEAM OF
SCIENTISTS AND COLLABORATORS AND
TO THE NATIONAL INSTITUTE ON
AGING FOR ALL THEIR SUPPORT OVER
MANY YEARS THAT ENABLING US TO
TRANSLATE BASIC SCIENCE
DISCOVERY INTO TRAJECTORIES TO
BOTH PREVENT AND POTENTIALLY
TREAT ALZHEIMER'S DISEASE.
THANK YOU.
>> NEXT SPEAKER IS DR.
BURNETT-BOWIE.
>> THANK YOU.
IT'S AN HONOR TO REPRESENT THE
SWAN STUDY.
THIS IS MY DISCLOSURE.
I SEE PATIENTS ONCE A WEEK
TUESDAY AFTERNOONS, THIS IS A
SLIDE I SHARE WITH THEM, WHICH
EMPHASIZES THAT WHEN WE CONSIDER
OSTEOPOROSIS IT'S NOT A DISEASE
WITHOUT CONSEQUENCE, AND THAT
WHEN YOU SUSTAIN A HIP FRACTURE,
THE IMPACT RELATED TO YEARS LOST
TO ILL HEALTH, DISABILITY, OR
EARLY DEATH, IS RELATED TO THAT
OF OVARIAN CANCER, WHEN YOU
SUSTAIN OSTEOPOROTIC FRACTURE,
UPPER ARM, WRIST, THIGH OR HIP,
THE IMPACT OF COLORECTAL CANCER.
SO WITH REGARD, REMEMBER WHEN I
FIRST SAW THIS STUDY, IN 2005,
TWO MILLION FRACTURES AFFECTING
WOMEN.
THAT FIRST YEAR, POST HIP
FRACTURE, THERE'S AN UP TO 24%
MORTALITY, AND UP TO 33% RISK OF
NO LONGER BEING ABLE TO LIVE
INDEPENDENTLY, AND THEREFORE
REALLY HAVING A CHANGE IN YOUR
FUNCTIONING.
IN 2025, TWO YEARS FROM NOW, ONE
YEAR FROM NOW, THE ANTICIPATION
IS THERE WILL BE 3 MILLION
OSTEOPOROTIC FRACTURES, THIS
SHOWS WHAT YOU DON'T WANT TO --
THERE ARE VERY FEW PLATES HERE,
MORE RODS, MORE HOLES IN THE
BONE THAT CONTRIBUTE TO
COMPRESSION FRACTURES.
WHILE FOR THE LONGEST TIME
OSTEOPOROSIS HAS BEEN FRAMED AS
A DISEASE OF OLDER WHITE WOMEN,
IN FACT ALL RACIAL AND ETHNIC
GROUPS ARE IMPACTED BY
FRACTURES, AND IN 2025 THE
GREATEST RISE INDIVIDUALS WHO
IDENTIFY AS HISPANIC.
THESE ARE FINDINGS FROM THE
STUDY SHOWING THAT ACROSS BLACK,
HISPANIC, ASIAN, PACIFIC
ISLANDER, NATIVE AMERICAN
INDIVIDUALS, RISE IN FRACTURE,
BETWEEN 2005 IN YELLOW AND 2025
IN RED.
THESE ARE SOME IMPORTANT AND
OFTENTIMES NOT DISCUSSED DATA
THAT THE IMPACT OF WHO IS
IMPACTED BY FRACTURES IN WHI
ACROSS AGAIN A BROAD SWATH OF
WOMEN, NATIVE AMERICAN, ASIAN,
BLACK, HISPANIC OR WHITE, THAT
THE NUMBER OF FRACTURES EXCEEDS
THE NUMBER OF CASES OF STROKE,
BREAST CANCER, OR CARDIOVASCULAR
DISEASE.
BLACK WOMEN ARE NOTABLY MORE
LIKELY TO EXPERIENCE MORTALITY,
DEBILITY OR DESTITUTION, DEFINED
BY MEDICAID.
THIS MEDICARE ANALYSIS DONE
BETWEEN 2010 AND 2016 BY DR.
WRIGHT AND TEAM LOOKING AT THE
DIFFERENT FRACTURE TYPES, TEXT
IS SMALL.
THIS IS FEMUR, THIS IS HIP,
HUMERUS.
YOU SEE IN COMPARISON TO WHITE
WOMEN, BLACK WOMEN ARE ON THIS
SIDE OF THE LINE, INCREASED RISK
OF ALL THESE PROBLEMATIC
OUTCOMES.
IF THE GOAL IS TO PREVENT
OSTEOPOROSIS OR FRACTURE HOW
DOES TRANSITION IMPACT BONE
LOSS, ARE THERE RACIAL OR ETHNIC
DEFERENCES IN BONE LOSS?
IT'S MY PRIVILEGE TO BE HERE
BECAUSE THE SWAN STUDY, STUDY OF
WOMEN'S HEALTH ACROSS ALL
NATIONS, IT STARTED BECAUSE OF
THE INCREDIBLE ADVOCACY OF DR.
VIVIAN PINN, OFFICE OF RESERVE
ON WOMEN'S HEALTH, AND AMAZING
LEADSERS LIKE DR. SHERMAN AND
DR. DUTTA TO SAY IN EARLY
1990s THERE WAS NO
LONGITUDINAL DATA RELATED TO
WHAT HAPPENS WITH MENOPAUSE.
AND THAT IT'S NEEDED TO BE A
REPRESENTATIVE SAMPLE OF WOMEN
BOTH FROM A RACE/ETHNICITY
PERSPECTIVE, BUT ALSO FROM
SOCIOECONOMIC PERSPECTIVE, WITH
THE GOAL IN SWAN LONGITUDINAL
EPIDEMIOLOGIC STUDY TO
UNDERSTAND PHYSICAL, BIOLOGICAL,
PSYCHOLOGICAL AND SOCIAL CHANGES
DURING THE TRANSITIONAL PERIOD.
SO, IN 1994, THE PLANNING
STARTED, AND IN THESE SEVEN
SITES ACROSS THE EAST COAST,
MIDWEST, WEST COAST, WE
ULTIMATELY ENROLLED 3302 WOMEN,
COMMUNITY BASED SAMPLING,
INVITED WITH ZIP CODES, RANDOM
SELECTION, INVITATION TO JOIN
SWAN AT EACH SITE HALF COHORT
WHITE, YOU SEE AS OF 20 -- OR
15, WHICH IS OUR PENULTIMATE
LAST FULL VISIT WE'VE JUST
COMPLETED VISIT 17 WITHIN THE
PANDEMIC, WHICH WAS LEARNING HOW
TO PIVOT WE'VE HAD 75% RETENTION
OF THE COHORT UP TO 15, AND SOME
KEY ASPECTS OF SWAN, SO SWAN IS
A STUDY WHERE THE GOAL WAS TO
UNDERSTAND BOTH THE TIMING OF
THAT FINAL MENSTRUAL PERIOD AND
THEN AFTER THAT THE ABILITY TO
LOOK AT THE CHANGES THAT
HAPPENED IN MID-LIFE AND WITH
MENOPAUSE TRANSITION AND HOW DID
THOSE CHANGES THEN INFORM LATER
LIFE.
SO, TO BE ELIGIBLE YOU HAVE TO
SELF-IDENTIFY, BE BETWEEN 42 AND
52, AT LEAST ONE OVARY, INTACT
UTERUS, NOT USING ART BECAUSE OF
THE GOAL TO IDENTIFY FINAL
MENSTRUAL PERIOD, HAVING A
PERIOD IN THE LAST THREE MONTHS.
AND THAT WAS ELIGIBILITY.
THIS IS JUST ONE OF THE AGAIN
HUNDREDS OF PUBLICATIONS THAT
HAVE COME FROM SWAN.
I'M A PROUD BONE HEAD, SO THE
IMPACT OF SWAN ON OUR
UNDERSTANDING OF BONE LOSS HAS
BEEN CONSIDERABLE.
WE -- I'LL SHOW A FEW HIGHLIGHTS
AND SUBSEQUENT SLIDES, BUT THIS
TIME PERIOD CALLED THE
TRANSMENOPAUSE, WHICH IS ONE
YEAR, AND TWO YEARS AFTER FMP,
CHANGES WITH REGARD TO BONE
DENSE SHY.
DENSITY.
CHANGES WITH ABSORPTION AND
HORMONES, ESTRADIOL, PRECEDE
WHAT HAPPENS WITH BONE DENSITY.
SO WITH REGARD TO THE CHANGE IN
BONE DENSITY, FROM SWAN, OF OUR
SEVEN SITES, WE HAVE DATA, BONE
COHORT FROM FIVE SITES,
UNFORTUNATELY NOT FROM OUR
LATINA WOMEN.
BONE DENSITY WAS ASSESSED USING
DEXA, ALLOWING US TO ASSESS BODY
COMPOSITION, I BRING THIS UP NOW
BECAUSE BODY MASS INDEX IS A KEY
ASPECT OF THE CHANGE THAT
HAPPENS IN BONE DENSITY.
BUT EVEN WITH RACE BEING A
SOCIAL CONSTRUCT, WE STILL WERE
OBSERVED VARIATION IN THE CHANGE
IN BONE DENSITY OVER TIME THAT
WAS IN ADDITION TO THE
RECOGNITION THAT IF YOU WERE
HEAVIER, HIGHER BMI, LESS LOSS.
I'LL SHOW ONE SLIDE FROM THAT.
IN THIS STUDY BY GREENDALE AND
TEAM I'LL FOCUS ON THE
CUMULATIVE 10-YEAR FINDINGS
HERE, TO THE VERY RIGHT OF THE
SCREEN.
BUT YOU'LL SEE AS YOU LOOK AT
THE DATA, IT'S ASSOCIATED WITH
SIGNIFICANT LOSS.
IF WOMEN WERE TO CONTINUE TO
LOSE AT THAT RATE WE WOULD BE --
YOU KNOW, WE WOULD BE ON THE
GROUND.
SO THE GOOD NEWS IS IT SLOWS
DOWN AFTER THAT THREE TO
FOUR-YEAR WINDOW.
AND THE OTHER KEY TAKEAWAY IS
THAT THE FOUR GROUPS, LOSS
OCCURS IN ALL FOUR GROUPS,
THERE'S BY WAY OF EXAMPLE LESS
LOSS IN THE TRANSMENOPAUSE IN
BLACK WOMEN.
WE AT MGH HAVE THE OPPORTUNITY
TO DO A DEEPER DIVE AND OBTAIN
EXTREME CT OR HIGH RESOLUTION,
PERIPHERAL Q.C.T WHICH IMAGES
FOREARM AND AREA JUST ABOVE YOUR
ANKLE.
AND OUR COHORT IS WHITE AND
BLACK.
WHAT YOU SEE, IT GIVES A BIOPSY,
VIRTUALLY BIOPSY OF BONE.
WHITE PARTICIPANT HAD THINNER
CORTICES AS COMPARED TO OUR
BLACK PARTICIPANT, AND THERE
WERE MORE, THAT'S TRUE ALSO FOR
BOTH RADIUS AND TIBIA, MORE
HOLES IN THE TRABECULA IN THE
WHITE THAN BLACK PARTICIPANT.
WITH REGARD TO THE RELATIONSHIP
WITH BMI, THIS WAS A STUDY WHERE
WE LOOKED LONGITUDINALLY AT OUR
PARTICIPANTS, WITH REGARD TO
CHANGES IN THE DIFFERENT EXTREME
CT MEASURES WITH TIME.
AND HERE WHAT YOU SEE IS IF YOU
WERE IN THE LOWEST -- I'M GOING
TO USE ONE MEASURE, WHICH IS
THE -- I DON'T KNOW IF TECHNICAL
SUPPORT CAN ADMIT DR. SIMON,
HERE YOU SEE THAT IF YOU WERE IN
THE LOWEST -- IF YOU HAD THE
GREATEST LOSS OF -- IF YOU WERE
THE LOWEST WEIGHT TERTILE,
EXCUSE ME, VERSE U.S. IN THE
HIGHEST WEIGHT TERTILE, THAT
THERE WERE DIFFERENCE WHERE IS
YOU LOST LESS WEIGHT, OR SAID
DIFFERENTLY IF YOU HAVE A LOWER
BMI OR WEIGHT YOU HAD GREATER
BONE DENSITY LOSS, THE EXTREME
CT, IN THAT EXAMINATION.
SO, WITH REGARD TO CHANGES IN
BONE DENSITY, WITH REGARD TO THE
MENOPAUSE AND MID-LIFE
TRANSITION, THIS KEY STUDY WAS
DONE WHICH LOOKED AT 15 YEARS OF
BODY COMPOSITION DATA, THAT WERE
COLLECTED.
AND IN THIS SUBSTUDY, JUST AGAIN
TO POINT OUT THAT ALL OF -- WE
HAVE DATA, WE DON'T HAVE DATA ON
OUR LATINA WOMEN, BUT WOMEN WERE
CAPTURED FROM BASELINE AGE OF 46
ON AVERAGE, THEY WERE HAVING
THEIR FINAL MENSTRUAL PERIOD
ROUGHLY ABOUT SIX YEARS AFTER
THAT, AND YOU SEE HERE THAT
THERE WERE DIFFERENCES IN BMI
ACROSS OUR GROUPS, WITH OUR
BLACK WOMEN HAVING THE HIGHEST
BMI AT BASELINE.
AND THEN WITH REGARD TO WHAT
OCCURRED WITH THE TRANSITION,
I'LL WALK YOU THROUGH AND POINT
OUT HERE THAT THE SOLID RED
LINE, I'M GOING TO LOOK AT THIS
AND NOT TRY TO POINT THERE.
THE SOLID RED LINE CAPTURES THE
CHANGE IN BODY WEIGHT THAT
HAPPENED ACROSS THOSE 15 YEARS.
THE GRAY LINE CAPTURING THE
FINAL MENSTRUAL PERIOD.
AGAIN, I'LL JUST SHOW ON BOTTOM
THE TRANSMENOPAUSE IS THIS --
FOR THIS ANALYSIS FROM TWO YEARS
BEFORE THE FMP TO TWO YEARS
AFTER THE FMP.
AND WHAT YOU SEE IS THAT THERE
ARE -- THERE'S A RISE ON AVERAGE
IN BODY WEIGHT AND BMI, CAPTURED
BY THE DASHED LINES OVER THAT
TRANSMENOPAUSE.
BUT YOU SEE STEEP INCREASES IN
YOUR FAT MASS, LESS STIP BUT
STILL RISING IN FAT PROPORTION
OF BODY COMPOSITION, THAT'S FAT,
AND A DECLINE IN THE LEAN MASS
BUT RELATIVELY GREATER DECLINE
IN THE PROPORTION OF LEAN WITH
THAT TRANSMENOPAUSAL, VERY
ACTIVE TIME, AND THEN A
PLATEAUING OF THE CHANGE ONCE
WOMEN ARE TWO YEARS POST
MENOPAUSAL.
HERE AGAIN, THERE WERE RACIAL
AND ETHNIC DIFFERENCES.
THE REASON WHY THIS ANALYSIS WAS
PARTICULARLY IMPORTANT, YOU CAN
IMAGINE THAT IF YOU WERE SOLELY
LOOKING AT THE CHANGE IN BODY
WEIGHT, WHICH IS WHAT WE COULD
DO CLINICALLY, YOU WOULD NOT
REALLY BE ABLE TO CAPTURE THE
CHANGES, NOR DECLINE IN LEAN
MASS PROPORTION.
AND THE FACT THAT OUR -- THERE
WERE DIFFERENCES WITH OUR
CHINESE WOMEN, SPECIFICALLY
HAVING LESS RISE IN FAT MASS,
AND GAIN IN LEAN MASS PROPORTION
AS OPPOSED TO A DECREASE SEEN IN
OTHER GROUPS.
WE STUDIED HOW CHANGES IN BODY
COMPOSITION, HOW THEY ARE
ASSOCIATED LONGITUDINALLY IN
BONE DENSITY AND FRACTURE.
WHAT WAS OBSERVED WITH LEAN MASS
DECLINED, THERE WAS ASSOCIATED
DECLINE IN FEMORAL NECK AND
LUMBAR SPINE BONE DENSITY,
SIMILARLY HIGHER FAT MASS, MORE
BONE DENSITY LOSS.
AND VERY SIMILAR PATTERNS FOR
LEAN MASS LOSS AND FAT MASS GAIN
ASSOCIATED WITH INCIDENT
FRACTURES AFTER THE MENOPAUSE
TRANSITION.
INTERVENTIONS CAN BE DONE.
THIS STUDY WAS EXCITING BECAUSE
WE ASSESSED OVER 17 YEARS
LEISURE TIME PHYSICAL ACTIVITY,
MOST POPULAR BEING WALKING.
IF YOU WERE WALKING,
CALISTHENICS, SWIMMING, YOU HAD
LESS LOSS IF YOU INCREASED YOUR
LEISURE TIME PHYSICAL ACTIVITY,
YOU ACTUALLY SLOWED THE LOSS IN
BMD OVER 17 YEARS, FOR THOSE AT
THE HIGHEST LEVEL OF LEISURE
TIME PHYSICAL ACTIVITY, AND THE
LOWEST AND HIGHEST LEVEL OF
LEISURE TIME PHYSICAL ACTIVITY,
WAS ASSOCIATED WITH HIGHEST
SPINE AND FEMORAL NECK BONE
DENSITY.
THIS IS A SMALL STUDY, NOT DONE
IN SWAN, BUT IN THESE
58-YEAR-OLD AND 58-YEAR-OLD PLUS
WOMEN, PUMPING WEIGHTS, UP TO
80-KILOS WITH TRAINERS.
AND WITH THAT, SIGNIFICANT
IMPROVEMENTS IN BONE DENSITY, SO
KEEPING IN MIND WHEN PATIENTS
ASK ME ABOUT WHAT CAN YOU DO
THAT'S NON-PHARMACOLOGICAL I
SHARE THIS BUT ALSO STRESS YOU
REQUIRE RESOURCES AS WELL AS
TIME AND A TRAINER TO ENSURE
THAT YOU'RE SAFE.
I WANT TO CLOSE BY SHARING THAT
WE DID SEE IN SWAN HIGHER
VITAMIN D LEVELS ASSOCIATED WITH
FEWER FRACTURES OVER TIME.
BUT CAUTIONARY NOTE THAT OURS IS
A TEN-YEAR ANALYSIS BUT IN THE
WOMEN'S -- IN THE VITAL STUDY
THERE WAS NOT AN INCREASE OR NOT
A DECREASED RISK OF FRACTURE
WITH VITAMIN D.
SO, I'M GOING TO FLASH QUICKLY.
THIS IS WHAT SWAN HAS SHOWN WITH
REGARD TO WHICH MEDICATIONS DO
AND DO NOT HAVE ASSOCIATED BONE
LOSS OR FRACTURE RISK.
AND I'M THINKING ABOUT WHEN YOU
TRY TO PUT THIS ALL TOGETHER,
WHAT DO WE KNOW FROM SWAN AND
OUR FINDINGS AT THE MID-LIFE AND
WITH MENOPAUSE TRANSITION, IF
YOU -- YOUR AGE OF FINAL
MENSTRUAL PERIOD IS MORE
IMPORTANT THAN CHRONOLOGIC AGE.
I SHOWED LEISURE TIME PHYSICAL
ACTIVITY.
THERE'S A STRONG ASSOCIATION
WITH DIABETES, PREDIABETES,
INSULIN RESISTANCE WITH
INCREASED RISK OF BONE DENSITY
LOSS, HIGHER BMI BEING
ASSOCIATED WITH LESS LOSS, BUT
IF YOU HAVE HIGHER FAT MASS
THAT'S ASSOCIATED WITH AN
INCREASED RISK OF LOSS, IT'S
POSSIBLE THAT IT IS THE -- WE
BOTH DID THAT AT THE SAME TIME.
THAT MAYBE IT IS THE
PRE-INFLAMMATION ASSOCIATED WITH
HIGHER FAT MASS THAT MIGHT
EXPLAIN THESE FINDINGS IN TERMS
OF WHY PATIENTS WHO HAVE
DIABETES HAVE MORE BONE DENSITY
LOSS.
SO, COMING TO MY LAST SLIDE,
WHAT IS UNKNOWN, WE DON'T KNOW
HOW THIS LOSS AT MID-LIFE
INFORMS BONE LOSS IN LATER
YEARS, SOMETHING WE'RE HOPING TO
STUDY WITHIN SWAN AGING.
CAN WE PREDICT WHO WILL FRACTURE
OR HAVE ACCELERATED BONE LOSS IN
LATER LIFE BASED ON EITHER BONE
DENSITY AT MID-LIFE OR OTHER
CHANGES IN THE MID-LIFE OR
MENOPAUSE TRANSITION?
CLINICALLY IF A WOMAN HAS NOT
FRACTURED BUT HAS OSTEOPENIA
RISK WHEN SHOULD PROSCRIPTION
MEDICATION BE INITIATED?
IN PARTICULAR FOR WOMEN WHO HAVE
OR ARE PAST TIMING OF ANY
POTENTIAL CONSIDERATION OF HRT,
AND AS WILL BE HIGHLIGHTED IN A
FINAL SLIDE HRT IS NO LONGER
LISTED BY THE OFFICE OF WOMEN'S
HEALTH AS A TREATMENT
CONSIDERATION FOR PATIENTS WITH
OSTEOPOROSIS AND WHAT CAN BE
DONE AT THE MID-LIFE TO REDUCE
THOSE RACIAL AND ETHNIC
DISPARITIES THAT I SHOWED.
I DOWNLOADED THIS AND I LOVE
THAT THERE'S PATIENT-FACING
MATERIAL OF SO MANY KINDS.
AND THIS IS WHAT IS LISTED FOR
PRESCRIPTION MEDICATIONS FOR
OSTEOPOROSIS THE NIH WEBSITE.
I WANT TO THANK -- AND THIS IS A
FRACTION OF THE NUMBER OF
INVESTIGATORS WITHIN SWAN, I
HIGHLIGHT HERE MY COLLEAGUES.
THESE ARE THE CURRENT AND PAST
RESEARCH COORDINATORS, WE TALKED
ABOUT MENTORSHIP, ALL OF THESE
AMAZING YOUNG WOMEN ARE EITHER
PHYSICIANS OR ON THEIR WAY, AND
SO THANK YOU FOR THE FUNDING AND
OF COURSE INCREDIBLE FUNDING
THAT SWAN HAS HAD OVER THE
YEARS.
THANK YOU FOR YOUR ATTENTION.
>> DR. HODIS, PLEASE.
I'D LIKE TO THANK DR. CLAYTON
AND DR. OTA WANG AND DR. DUTTA
FOR THE INVITATION.
IT'S A PRIVILEGE TO BE HERE.
THIS IS OUR CURRENT FUNDING.
AND LIKE THE TWO PREVIOUS
SPEAKERS, I'M GOING TO SHOW WORK
TODAY THAT COULD HAVE NEVER BEEN
ACCOMPLISHED WITHOUT THE HELP OF
NIH AND THE PART OF OUR PROGRAM
I'M GOING TO DISCUSS TODAY WHICH
DOVETAILS WITH WOMEN'S HEALTH,
PREDOMINANTLY FUNDED THROUGH
NIA.
AS YOU HEARD TODAY ALREADY,
CARDIOVASCULAR DISEASE IS
LEADING CAUSE OF DEATH IN WOMEN,
CONTINUES TO RISE, CONTINUES TO
BE A PROBLEM.
VAST MAJORITY OF WOMEN WHO DIE
FROM CARDIOVASCULAR DISEASE DO
SO IN POST MENOPAUSAL PERIOD.
VERY FEW WOMEN DIE IN
PRE-MENOPAUSAL PERIOD FROM
CARDIOVASCULAR DISEASE.
50 OR SO YEARS AGO, ACROSS THE
ENTIRE AGE RANGE, POST
MENOPAUSAL WOMEN ARE TWO TO
SIX-FOLD GREATER RISK FOR
CORONARY HEART DISEASE THAN
PRE-MENOPAUSAL WOMEN.
WITH THIS, THE QUESTION IS WHO
ARE THE WOMEN MOST LIKELY TO BE
PROTECTED?
WELL, 40 YEARS -- APPROXIMATELY
40 YEARS AND DOZENS OF
OBSERVATIONAL STUDIES HAVE
POINTED OUT THAT WOMEN WHO
SELECT FOR HORMONE THERAPY HAVE
REDUCTION IN CORONARY HEART
DISEASE, THIS IS TRUE FOR
ALL-CAUSE MORTALITY.
LARGE RANDOMIZED TRIALS, HAVE
SHOWED A NULL EFFECT, WOMEN
RANDOMIZED TO HORMONE THERAPY.
VERSUS PLACEBO.
WITH INSTRUCTIONS TO LOOK AT WHY
THERE IS THIS DIFFERENCE.
HYPOTHESIS BASED ON
OBSERVATIONAL STUDIES SHOWN
HERE, COLLECTIVELY LOOKED AT THE
AGES OF WOMEN, TIME FOR
MENOPAUSE, PRE-SELECTED HORMONE
THERAPY, PREDOMINANTLY HAD
MENOPAUSAL SYMPTOMS, RANDOMIZED
TRIALS HAVE BEEN MUCH OLDER
WOMEN, MUCH FURTHER FROM
MENOPAUSE, EXCLUDED AS BEST AS
POSSIBLE, MENOPAUSAL RELATED
SYMPTOMS AND YOU CAN SEE THESE
ARE TWO DIFFERENT POPULATIONS OF
WOMEN.
EARLY ON THIS IDEA OF TIMING, AS
YOU HEARD FROM ROBBIE, IT WAS
HYPOTHESIZED THE EFFECT OF
MENOPAUSE HORMONE THERAPY ON
ATHEROSCLEROSIS, WHERE WE WERE
COMING FROM, AS CLINICAL
ADVANCES ARE DEPENDENT UPON WHEN
HORMONE THERAPY IS INITIATED IN
RELATION TO MENOPAUSE AND/OR
AGE.
NOT ABLE TO PARSE IT OUT YET.
THAT'S ONE OF THOSE THINGS THAT
NEEDS TO BE DONE, IS IT AGE OR
MENOPAUSE?
MANY LINES OF EVIDENCE HAVE
CONVERGED IN BASICALLY
SUPPORTING THIS HYPOTHESIS.
SO PRIOR TO THIS TIMING
HYPOTHESIS, IF YOU WILL, THE
ENDOTHELIUM HYPOTHESIS WAS
FLOATED, WHAT WAS THOUGHT TO BE
A DUALITY OF ESTROGEN AND
EFFECTS ON ATHEROSCLEROSIS.
WE KNEW EARLY ON THERE WAS MANY
BENEFICIAL EFFECTS OF ESTROGEN
ON ATHEROSCLEROSIS.
WITHIN SIX YEARS OF THE LAST
MENSTRUAL PERIOD, THERE'S
BEGINNING TO LOSE THE BENEFITS
FROM ESTROGEN.
THERE IS EVIDENCE THIS IS DUE TO
METHYLATION PROMOTER SITE OF THE
E.R. ALPHA GENE.
AND THEN LATER WHICH ACCOUNTED
FOR DUALITY WAS THIS POSSIBLE
ADVERSE EFFECT ON
ATHEROSCLEROSIS OR NULL EFFECT.
ALONG PATHOGENESIS OR AGING OF
VESSELS, THIS IS WHERE WE THEN
OVERLAY EFFECTS AND WHERE THE
DATA AS I'LL SHOW YOU IN A
MOMENT TEND TO THEN VALIDATE AND
WHERE THE TIMING HYPOTHESIS IS
DERIVED BASED ON MECHANISTIC
UNDERSTANDING OF THAT PROCESS.
EARLY ON WE CONDUCTED A SISTER
STUDY, LOOKING AT ESTRADIOL,
EARLY OR SUBCLINICAL
ATHEROSCLEROSIS, HEALTHY
ENDOTHELIUM, COMPLETELY HEALTHY
WOMEN, NO SYMPTOMS OF HEART
DISEASE, NO DIABETES, ET CETERA.
YOU CAN SEE THERE WAS A
SIGNIFICANT TREATMENT EFFECT,
VERSUS PLACEBO, IN THESE WOMEN.
WE LOOKED AT WOMEN WITH DISEASED
VESSELS, THIS IS A SERIAL TRIAL,
ESTABLISHED CORONARY DISEASE
WHEN ENTERING THE STUDY,
ESTRADIOL ALONE OR PLUS MPA
RELATIVE TO PLACEBO, NO
TREATMENT EFFECT.
THIS IS REALLY THE FIRST
EVIDENCE WE HAD CONSISTENT WITH
THE HEALTHY ENDOTHELIUM OR
TIMING HYPOTHESIS, IF YOU WILL,
WHICH DEMONSTRATES OR HOW WE
DEMONSTRATED HERE, IF YOU START
HORMONE THERAPY EARLY YOU
PREVENT OR SLOW DOWN THIS
VASCULAR AGING PROCESS, IF YOU
START IT LATE YOU CAN NO EFFECT
OR POTENTIALLY CAUSE PLAQUE
RUPTURE, WHICH THERE'S SOME
CLINICAL EVIDENCE FOR.
THIS IS NICELY DEMONSTRATED IN
THIS SPECIES OF ANIMAL.
THIS EFFECT IS SEEN IS MULTIPLE
SPECIES.
THIS IS MICE, NON-HUMAN PRIMATE,
IT'S BEEN SEEN IN RATS, AND
BASICALLY IF YOU START HORMONE
THERAPY, ESTRADIOL IN THIS CASE,
CREATE ATHEROSCLEROSIS VIA
CHOLESTEROL FEEDING AND OTHER
PROCESSES, YOU CAN PREVENT NEW
LESION FORMATION.
WITH ESTROGEN.
HOWEVER, IN -- OOPS.
HOWEVER, IN ANIMALS THAT DID NOT
RECEIVE -- SORRY, I DON'T KNOW
WHY IT'S NOT WORKING.
DID NOT RECEIVE HORMONE THERAPY,
THEY PROGRESSED WITH NEW
LESIONS.
FAR GRAPH YOU CAN SEE WHEN THEY
DID RECEIVE ESTROGEN OR PLACEBO,
IT DIDN'T MATTER, ONCE THE
LESIONS WERE ESTABLISHED THERE
WAS NO TREATMENT EFFECT.
SO AGAIN IT APPEARS AT LEAST
WITH ANIMALS, PRETTY CONSISTENT
EFFECT THAT YOU CAN PREVENT NEW
LESION FORMATION BEFORE
ATHEROSCLEROSIS DEVELOPS BUT YOU
CAN'T REVERSE IT OR INHIBIT IT
ONCE IT'S ESTABLISHED.
MAYBE THE BATTERY IS DYING.
I'M GOING TO SKIP FORWARD TO
WHERE WE ARE -- I CAN'T - -
DOESN'T SEEM TO BE RESPONDING.
NEXT SLIDE.
TO STUDY TIMING HYPOTHESIS WE
COMPLETED THIS STUDY PUBLISHED
IN NEW ENGLAND JOURNAL, 2015.
IT STILL REMAINS THE ONLY DIRECT
TEST OF TIMING HYPOTHESIS, 643
HEALTHY WOMEN, RANDOMIZED ORAL
17 BETA VERSUS PLACEBO,
STRATIFIED BASED ON TIME SINCE
MENOPAUSE.
SO WOMEN CLOSE TO MENOPAUSE,
WITHIN SIX YEARS, AND 10 OR MORE
YEARS BEYOND MENOPAUSE.
YOU'LL HAVE TO ADVANCE IT.
THAT'S GOOD.
YOU CAN SEE VERY CLEAR
DISTINCTION BETWEEN WOMEN CLOSE
TO MENOPAUSE WITHIN 3 1/2 YEARS
AND EARLY GROUP, AND LATE GROUP
OF WOMEN ABOUT 14 1/2 YEARS PAST
MENOPAUSE, AGE IS GREATER IN
WOMEN MORE THAN TEN YEARS.
NEXT SLIDE.
BOTTOM PORTION OF THE GRAPH,
THESE ARE THE WOMEN RANDOMIZED
WITHIN SIX YEARS OF MENOPAUSE,
ABOUT YEAR AND A HALF TO TWO
YEARS THERE WAS A SIGNIFICANT
TREATMENT EFFECT IN THIS GROUP
OF WOMEN, ESTROGEN VERSUS
PLACEBO, UPPER TWO LINES YOU CAN
SEE NO TREATMENT EFFECT, THESE
ARE MORE THAN TEN YEARS FROM
MENOPAUSE.
DIRECT EVIDENCE FOR TIMING
HYPOTHESIS, EARLY TREATMENT OR
REDUCTION OF ATHEROSCLEROSIS,
LATE INTERVENTION TEN YEARS OR
MORE NO EFFECT.
NEXT SLIDE.
SO NOW THIS IS ATHEROSCLEROSIS.
WE KNOW ATHEROSCLEROSIS IS THE
MAJOR UNDERLYING CAUSE OF
CARDIOVASCULAR DISEASE.
THE QUESTION IS HOW DOES THIS
LOOK IN TERMS OF CORONARY HEART
DISEASE OUTCOMES?
THIS WAS THE FIRST META-ANALYSIS
CONDUCTED, STANFORD.
BOX INDICATES WOMEN WHO ARE
CLOSE TO MENOPAUSE, WITHIN SIX
YEARS OR LESS THAN 60 YEARS OLD.
YOU CAN SEE A SIGNIFICANT EFFECT
IN META-ANALYSIS, A FEW DOZEN
STUDIES, REDUCTION OF HEART
DISEASE, WOMEN RANDOMIZED TO
HORMONE THERAPY VERSUS PLACEBO.
AND THE COMPANION SLIDE, YOU CAN
SEE THAT THERE'S ALSO A
SIGNIFICANT REDUCTION IN
ALL-CAUSE MORTALITY, NULL
EFFECTS IN WOMEN MORE THAN TEN
YEARS OR OLDER, MORE THAN TEN
YEARS SINCE MENOPAUSE, OLDER
THAN 60 YEARS OF AGE.
NEXT SLIDE.
THESE WERE CONFIRMED BY COCHRANE
META-ANALYSIS, SAME EFFECT.
SIGNIFICANT REDUCTION IN HEART
DISEASE, ALL-CAUSE MORTALITY, IN
WOMEN RANDOMIZED TO HORMONE
THERAPY, NO EFFECT IN THOSE
RANDOMIZED GREATER THAN TEN
YEARS OR GREATER THAN 60 YEARS
OLD.
NEXT SLIDE.
NOW, THE CLOSEST STUDY THAT'S
BEEN CONDUCTED IS A DANISH
OSTEOPOROSIS STUDY WHERE THEY
LOOKED AT CARDIOVASCULAR DISEASE
OUTCOME.
THESE WOMEN WERE WITHIN -- THIS
IS AVERAGE TIME, SEVEN MONTHS
FROM MENOPAUSE, AVERAGE AGE 50
YEARS.
THIS IS THE CLOSEST RANDOMIZED
TRIAL OF WOMEN THAT WE HAVE TO
EMULATE OR REALLY TEST THE
OBSERVATIONAL STUDIES.
AND YOU CAN SEE UP TO TEN YEARS,
THE LINE DELINEATES TEN-YEAR
POINT, WOMEN ON HORMONE THERAPY
VERSUS CONTROL GROUP.
AND YOU CAN SEE SIGNIFICANT
REDUCTION IN THIS KAPLAN-MEIER
CURVE, IN THE NUMBER OF EVENTS
VERSUS CONTROL GROUP.
AND THEN AS THE WOMEN EXITED
THEY WERE FOLLOWED AND 16 YEARS
LATER THAT TREATMENT EFFECT WAS
STILL EVIDENT.
NEXT SLIDE.
GO BACK.
THAT'S IT, YEAH, SORRY.
YEP.
SO WHEN YOU TAKE A LOOK AT THESE
STUDIES WHERE WOMEN WERE --
STUDIES ANALYZED, INCLUDING
COCHRANE AND STANFORD, THE ELITE
STUDY THAT I SHOWED YOU IN
IMAGING, ALL REALLY DO COMPORT
OR ARE CONSISTENT WITH THE
OBSERVATIONAL STUDIES SHOWING
REDUCTION IN CORONARY HEART
DISEASE.
AGAIN, TRUE FOR ALL-CAUSE
MORTALITY.
NEXT SLIDE.
NEXT SLIDE AGAIN.
MORE ABOUT MORTALITY, WHI STUDY,
SUBGROUP OF WOMEN LESS THAN 60
AND RANDOMIZED, MORTALITY IN THE
NEXT GROUP, CANCER MORTALITY,
AND OTHER MORTALITY.
YOU CAN SEE THAT NOT ONLY IS
ALL-CAUSE MORTALITY REDUCED BUT
SO ARE THE SPECIFIED MORTALITIES
ALSO.
NEXT SLIDE.
THIS COMES FROM 18-YEAR
CUMULATIVE FOLLOW-UP.
THERE'S EVEN REDUCTION IN
ALZHEIMER'S DISEASE OR DEMENTIA
MORTALITY.
NEXT SLIDE.
SO, WHAT'S REALLY IMPORTANT
ABOUT WOMEN AND YOU WANT TO TALK
ABOUT A SEX DIFFERENTIATOR FROM
MEN IS DIABETES.
THIS IS REALLY ONE OF THE ONLY
RISK FACTORS THAT ERASES THE
PRE-MENOPAUSAL PROTECTION WOMEN
HAVE FROM HEART DISEASE.
THAT'S DIABETES.
50 YEARS AGO FRAMINGHAM SHOWED
US THAT WOMEN ARE ALSO AT
GREATER RISK FOR HEART DISEASE
THAN ARE MEN WHEN THEY HAVE
DIABETES, YOU SEE IN THE FAR
PART OF THE GRAPH A RISK RATIO
OF ABOUT 5:1 OF DIABETES TO
NON-DIABETIC DIABETES --
DIABETIC WOMEN, AND OVER ON THE
CLOSER PART OF THE GRAPH, LEFT
PART, IN MEN THAT'S ABOUT HALF,
2 1/2-FOLD RISK FOR CORONARY
HEART DISEASE IN MEN WHO HAVE
DIABETES VERSUS NO DIABETES.
NEXT SLIDE.
THAT'S IMPORTANT BECAUSE WE'VE
KNOWN FOR QUITE A WHILE, AGAIN
THIS IS YOUR LEFT LOWER QUADRANT
THERE'S A CONSISTENT EFFECT OF
HORMONE THERAPY ON NEW ONSET
DIABETES, WHETHER YOU LOOK AT
LARGE META-ANALYSIS OF OVER 100
RANDOMIZED TRIALS, INDIVIDUAL
STUDIES, I'M JUST SHOWING WHI
HRT, CONSISTENT REDUCTION IN NEW
ONSET, DIFFERENTIATING FROM
STATIN USE IN WOMEN, INCREASED
NEW ONSET DIABETES.
IT'S THESE DATA THAT LED TO THE
ADDED LABELING OF STATIN THERAPY
IN APRIL OF 2012, OF THE WARNING
OF NEW ONSET DIABETES WITH USE
OF STATINS.
THAT RISK IS 10 PER 10,000, MORE
THAN A RARE RISK.
NEXT SLIDE.
SO THIS IS WHI DATA ALSO IN
WOMEN LESS THAN 60 YEARS OF AGE.
DATA IS GREAT BECAUSE WE CAN
LOOK AT ABSOLUTE RISK.
WHAT REALLY STANDS OUT IN ALL
THE OUTCOMES ANALYZED IN WHI
PRETTY MUCH DISPLAYED HERE IS
THAT THE ONE RISK FACTOR, ONE
RISK OPT OUT WAS THE CE PLUS MPA
TRIAL, SIGNIFICANT EFFECT ON
DEEP VAIN THROMBOSIS, ALL OTHERS
WERE INSIGNIFICANT.
YOU CAN SEE BY RED CIRCLE AND
ARROW BELOW THE RARE LEVEL OF
RISK.
NEXT SLIDE.
IN CONCLUSION, CARDIOVASCULAR
DISEASE IS THE NUMBER ONE CAUSE
OF DEATH IN WOMEN, POST
MENOPAUSAL INCREASED WOMEN ARE
AT INCREASED RISK FOR
CARDIOVASCULAR DISEASE.
WHETHER THAT'S DUE TO THE LOSS
OF ESTROGEN OR NOT IS AN AREA
THAT IS UNDER ACTIVE
INVESTIGATION.
SO MENOPAUSAL HORMONE THERAPY IS
COST EFFECTIVE, IT'S
SEX-SPECIFIC THERAPY, APPEARS TO
REDUCE ALL-CAUSE MORTALITY AND
SPECIFIC MORTALITIES, REDUCES
HEART DISEASE, BONE FRACTURE
REDUCED IN NON-SELECTED
POPULATION, MOST STUDIES DONE IN
HIGH-RISK FRACTURE RISK
PATIENTS, AND REDUCES NEW ONSET
DIABETES.
BENEFITS OF MENOPAUSAL HORMONE
THERAPY CLEARLY OUTWEIGH THE
RISK WHEN INITIATED AROUND THE
TIME OF MENOPAUSE.
NOW, THERE'S MANY, MANY
UNANSWERED QUESTIONS.
ONE OF THE ISSUES, I DIDN'T HAVE
TIME TO GO INTO, THERE'S
THEORIES IT'S PROGESTERONE
AGENT, NOT PROVEN BUT THEORIZED.
THERE'S NEW CLASSES OF DRUGS,
TSEC IS ONE OF THEM, AND NIA
FUNDED US TO LOOK AT THIS
BECAUSE WE CAN DELIVER ESTROGEN
WITHOUT THE RISK, IF THERE IS
ANY, OF PROGESTERINAL AGENT TO
PROTECT THE UTERUS, TO COMPLETE
IN THE NEXT YEAR OR TWO.
CONJUGATED ESTROGEN, AS YOU MAY
KNOW, IN WHI THERE WAS
STATISTICALLY SIGNIFICANT
REDUCTION OF BREAST CANCER WITH
CONJUGATED ESTROGEN, AND
ESTROGEN-ONLY STUDY, THIS IS A
GOOD CANDIDATE DRUG, WHAT
PROTECTS THE UTERUS IS A
SELECTIVE ESTROGEN RECEPTOR
MODULATOR, MORE COMMONLY CALLED
ESTROGEN AGONIST ANTAGONIST.
CONJUGATED ESTROGENS ARE REALLY
SERMS.
THE OTHER IMPORTANT AREA THAT
WE'RE PURSUING NOW IS TO
UNDERSTAND VASCULAR RESPONSE IN
THE BRAIN IN RELATION TO ADRD.
THIS ARTICLE SUMS THIS UP.
IT ALSO SPELLS OUT SOME OF THE
OTHER SEX DIFFERENCES THAT I
WASN'T REALLY ABLE TO COVER IN
ONLY 15 MINUTES.
I GUESS I HAD TEN MINUTES.
THANKS.
MY PARTNER SAYS I NEVER TALK.
I GRUNT.
I THINK THAT'S A MAN THING.
THE ONLY TIME I COME ALIVE AND
AM ANIMATED, TALK, TALK, TALK,
IS WHEN I TALK ABOUT MENOPAUSE
AND WOMEN'S HEALTH.
THANK YOU ALL.
APPRECIATE IT.
>> THANK YOU FOR THREE EXCELLENT
TALKS.
ARE THERE ANY QUESTIONS AROUND
THE TABLE FOR SPEAKERS?
AS WE LEARN ABOUT ATTITUDES AND
EXPERIENCES OF MENOPAUSE ACROSS
DIFFERENT ETHNIC AND RACIAL
GROUPS, IMPACT OF MENOPAUSAL
LATER OUTCOMES, WHAT IS MONEY
ABOUT HORMONE THERAPY IN, FOR
EXAMPLE, BLACK WOMEN OR ACROSS
RACE/ETHNICITY GROUPS WITH
RESPECT TO TIMING HYPOTHESIS AND
PREVENTION OF CHRONIC CONDITIONS
IN LATER LIFE?
>> THAT'S A GREAT QUESTION.
AND WE STRUGGLE HARD TO MAKE
SURE THAT OUR TRIALS WERE WELL
REPRESENTED, AND WITH THAT SAID,
THERE'S SMALL CUP GROUPS BUT WE
DIDN'T REALLY SEE MUCH
DIFFERENCE IN TERMS OF THE
CARDIOVASCULAR BUT WE KNOW
THAT'S PROBABLY NOT TRUE.
I JUST SAW A GREAT LECTURE
TALKING ABOUT BONE DIFFERENCES,
AND WE KNOW THAT EXISTS.
SO IT'S HARD TO -- BIOLOGY IS
BIOLOGY.
IT'S HARD TO BELIEVE WE'D BE
DIFFERENT IN THE CARDIOVASCULAR
SYSTEM.
WE NEED MUCH LARGER STUDIES TO
UNDERSTAND THAT.
>> SO A FOLLOW-UP QUESTION FOR
DR. BRINTON.
SO, RELATED TO THE DATA
PRESENTED BY DR. HODIS WHAT ARE
YOUR THOUGHTS REGARDING THE
TIMING AND DURATION OF
MENOPAUSAL HORMONE THERAPY THAT
MIGHT BE NEEDED TO PROMOTE
COGNITIVE HEALTH?
>> I THINK WHAT IS REALLY
IMPRESSIVE IS THE
REPRODUCIBILITY ACROSS DIFFERENT
SYSTEMS, CARDIAC SYSTEM, THE
BRAIN, THAT INTERVENTION AS YOU
MIGHT RECALL, THE SYSTEMS OF
BIOLOGY ARE CHANGING DURING THIS
COURSE OF THIS TRANSITION STATE.
AND THAT INTERVENTION AT ONE
POINT EARLY ON WHEN SYMPTOMS
FIRST APPEAR CAN CHANGE THE
TRAJECTORY OF AGING.
FROM A VULNERABLE AGING PROFILE,
WHETHER THAT'S FROM A
NEUROLOGICAL PERSPECTIVE, OR A
CARDIOVASCULAR PERSPECTIVE, OR
AN IMMUNE PERSPECTIVE.
AND KIND OF AN AUTOIMMUNE
DISEASE PERSPECTIVE.
I'VE BEEN QUITE IMPRESSED
STUDYING THE IMMUNE SYSTEM WAS
SOMETHING THAT I FOUGHT TOOTH
AND NAIL UNTIL THE BRAIN TOLD ME
YOU MUST.
AND SO WE DID.
THIS IS ANOTHER SHARED COMMON
DRIVER ACROSS THESE SYSTEMS OF
BIOLOGY, AND IT WILL BE
INTERESTING TO KNOW WHETHER THIS
IS TRUE IN BONE AS WELL, IS
ACTIVATION OF THE IMMUNE SYSTEM.
AND WE TYPICALLY GROUP THAT
AROUND INFLAMMATION, BUT OUR
RESEARCH AS WELL AS OTHERS HAVE
DIFFERENTIATED BETWEEN THERE'S
THIS EARLY ACTIVATION OF A
WARNING SIGNAL, THE INNATE
IMMUNE SYSTEM, VERSUS NOW WE'RE
JUST DEALING WITH HOW DO WE
CONTROL AN IMMUNE -- A SYSTEM
RESPONSE WITH THE ADAPTIVE
IMMUNE SYSTEM ACTIVATION.
SO, THAT THERE'S THIS PROCESS,
IN THE CASE OF THE BRAIN, OF
CATABOLISM OF WHITE MATTER,
CONSTANT GENERATION OF MYELIN
DEBRIS, AND THAT THE ADAPTIVE
IMMUNE SYSTEM IS TAKING CARE OF
THAT.
I SUSPECT THAT THAT MAY BE THE
CASE IN CARDIOVASCULAR DISEASE
AS WELL.
AND IT WOULD BE INTERESTING TO
KNOW WHETHER YOU HAVE ANY
KNOWLEDGE AROUND WHETHER THAT'S
TRUE IN BONE.
>> I DON'T.
I THINK FOR MOST OF THE
DISEASES, WHERE THERE MIGHT BE
IMMUNE ACTIVATION, THE
MEDICATIONS USED TO MANAGE THAT
ARE SO HARMFUL TO BONE THAT
MAKING IT DIFFICULT.
WITH RESPECT TO THE DURATION
ISSUE, I THINK THAT -- SO
ESTROGEN IS NOT -- YOU KNOW, A
MORTALITY TRUCK.
IT PROMOTES HEALTHY AGING.
BUT THERE'S -- WHAT WE FOUND IS
THREE PROGRAMMING OF AGING,
EARLY CHRONOLOGICAL AGING,
ENDOCRINE AGING, THERE'S LATE
CHRONOLOGICAL AGING.
AND WHAT OUR WORK HAS SHOWN, AND
HOWARD'S AND I KNOW SHERRI ANN,
ESTROGEN THERAPY AT THE TIME OF
MENOPAUSAL SYMPTOMS CHANGES THE
TRAJECTORY OF AGING.
SO, IT'S NOT -- WE ALL CROSS
OVER.
WE ALL HAVE A LIFESPAN.
AND ESTROGEN SUSTAINS IN MANY
RESPECTS THAT ABILITY TO AGE
WELL.
BUT THEN THERE'S THE AGING
PROGRAMS, RIGHT?
AND THAT'S A VERY DIFFERENT SET
OF PROGRAMS THAT CAN BE
MODIFIABLE THROUGH EXERCISE, AS
WELL AS DIET.
SO THERE ARE THREE -- AT LEAST
THREE AGING PROGRAMS.
>> THE AGING HYPOTHESIS EXISTS
FOR BREAST CANCER, EXACT
OPPOSITE DIRECTION.
I WONDER IF YOU WANT TO COMMENT
ABOUT THAT?
BECAUSE EARLIER ONES AGAIN
HORMONE THERAPY AFTER MENOPAUSE,
THE HIGHER THE RELATIVE RISK IS.
AND THAT IS ONE OF THE REASONS
IT'S CHALLENGING FOR YOUNGER
WOMEN TO MAKE THESE DECISIONS
BECAUSE OF THE COLLECTION OF
OUTCOMES AFFECTED BY ESTROGEN,
ONE REASON WOMEN'S HEALTH
INITIATIVE POPULATION WAS SKEWED
A LITTLE BIT HIGHER WAS TO MAKE
SURE THAT ADVERSE EFFECTS ON
BREAST CANCER WEREN'T -- BEFORE
WE COULD SEE EXPECTED BENEFITS
ON CARDIOVASCULAR DISEASE,
BECAUSE CARDIOVASCULAR DISEASE
IS VERY RARE AMONG WOMEN IN
THEIR 50s.
>> SO WE DID AN ANALYSIS,
FOCUSING FROM A MORE NEUROLOGIC
PERSPECTIVE BUT WE ASKED THE
QUESTION, ARE THERE DIFFERENCES
IN THE PROGESTINS, FROM A
NEUROLOGIC PROGRESSION.
THE OTHER PROGESTINS, IF YOU DO
CONTINUOUS COMBINED HORMONE
THERAPY WHERE ESTROGEN PLUS
PROGESTIN, THAT IS AFFECTED IN
INHIBITING ESTROGEN ACTION.
IN MULTIPLE ORGANS, INCLUDING
THE BRAIN.
THE NORMAL BIOLOGY HAS ESTROGEN
RISING, DECLINING, AND THEN
PROGESTERONE COMING ON.
WHEN THE HORMONE THERAPY IS
CONSISTENT WITH THAT NATURAL --
WITH THE DESIGN OF THE SYSTEM,
THEN THERE IS BENEFIT.
WHEN IT'S CONTINUOUS COMBINED,
IT'S INHIBITORY.
NOW, THAT WORKS WELL IN THE
UTERUS, EXCEPT FOR HYDROXY
PROGESTERONE ACETATE, IT DRIVES
PROLIFERATION OF THE CELLS, AND
IT RELIES ON CELL CYCLE
CHECKPOINT PROGRAMS.
SO IT'S DRIVING ALL OF THIS
PROLIFERATION AND HOPING THAT
THERE WILL BE A CHECK POINT.
THAT'S THE SAME CHECKPOINT
ACTIVATION, THE SAME IN BREAST,
RIGHT?
SO I REALLY THINK THE PROGESTIN,
THE TYPE OF PROGESTIN REALLY
MATTERS, AND HOWARD, I THINK
YOU'RE MORE KNOWLEDGEABLE AROUND
THAT.
>> I THINK THE TYPE MATTERS, AND
AS YOU SUGGESTED, SO IS THE
PATTERN THAT YOU ADMINISTER IT.
LIKELY SAFER TO FOLLOW BIOLOGY
BUT, AGAIN, THIS IS A BIG AREA
THAT WE DON'T KNOW FOR SURE.
THERE'S NOT ENOUGH DATA, NOT
ENOUGH STUDIES.
>> TO DOVETAIL ON YOUR QUESTION,
WE ASKED THE QUESTION, BECAUSE
WE FOUND ESTROGEN THERAPY
REDUCES RISK OF DEVELOPING
ALZHEIMER'S, ALS, MULTIPLE
SCLEROSIS AND PARKINSON'S
WHENNED A ALL -- WHEN
ADMINISTERED AT THE RIGHT TIME,
WHETHER THERE'S AN IMPACT ON
THIS TIMING OF INITIATION, AND
MOSTLY WHAT WE FIND IS THAT
THERE ISN'T.
THERE'S NO BENEFIT, THERE'S NO
HARM.
I'M NOT SURE WHY WOMEN ARE
ADMINISTERED HORMONE THERAPY SO
LATE.
I KNOW THAT IN THE CLINICAL
TRIALS IT WAS SO THAT NO ONE
WOULD BE UNBLINDED TO THE
INTERVENTION, RIGHT?
SO IF A WOMAN HAD HOT FLASHES
AND SHE'S RANDOMIZED TO AN
ESTROGEN, THEN EVERYBODY'S
UNBLINDED INCLUDING PARTICIPANT.
SO I THINK THERE ARE, YOU KNOW,
ISSUES AROUND THOSE DESIGNS THAT
ARE CRITICAL, TO CONSIDERING THE
DATA.
I DON'T KNOW, SHERRI ANN --
>> YOUNGER WOMEN DON'T HAVE THE
CLINICAL EVENTS SO YOU CAN'T SEE
DIFFERENCE IN ANY OF THESE
FRACTURES, WHATEVER, IN
50-YEAR-OLDS, WITHOUT DOING TEN
TIMES AS MANY PEOPLE.
>> WE ASKED THE QUESTION, WE
WENT AND ADDRESSED FROM A
NEUROLOGICAL PERSPECTIVE WHAT IS
THE IMPACT OF PHARMACOLOGICAL
BREAST CANCER THERAPIES,
TAMOXIFEN, RALOXIFENE, AROMATASE
INHIBITORS.
WE FOUND THAT THE AROMATASE
INHIBITIERS AND TAMOXIFEN REDUCE
RISK OF DEVELOPING
AGE-ASSOCIATED NEURODEGENERATIVE
DISEASE, HALF AT FULL ESTROGEN.
RALOXIFENE DID NOT.
IT'S NOT BECAUSE RALOXIFENE
ISN'T EFFECTIVE IN A PETRI DISH,
A MILD ESTROGEN AGONIST.
IT DOESN'T CROSS THE BLOOD-BRAIN
BARRIER AT CLINICAL
CONCENTRATIONS.
IF YOU DOUBLE THAT, THEN YOU'LL
GET RALOXIFENE IN THE BRAIN.
QUITE SURPRISING TO ME
PARTICULARLY AROMATASE
INHIBITORS ARE ACTING AS A WEAK
ESTROGEN AGONIST IN BRAIN.
I WOULD HAVE NEVER PREDICTED
THAT.
>> DR. HODIS WAS KIND ENOUGH TO
MENTION ESTROGEN EFFECT ON
BREAST CANCER PROTECTIVE,
DISAPPEAR IN YOUNGER WOMEN, ONLY
IN OLDER ONES.
THE TIMING HYPOTHESIS APPLIES TO
ESTROGEN ALONE AS WELL.
>> THEY DISAPPEAR THROUGH THE
INTERVENTION?
>> IF YOU LOOK BY AGE.
>> I'M TALKING ABOUT WOMEN
YOUNGER THAN 60.
>> YES, THERE'S NO BENEFIT IN
THE YOUNGER WOMEN.
>> BUT OVERALL IN THAT STUDY THE
REDUCTION WAS MUCH MORE
SIGNIFICANT FOR DCIS AND SO I
MEAN I DON'T -- BOTTOM LINE IS
IT REDUCED IT IN THE TRIALS,
DURING INTERVENTION, AND
CERTAINLY DIDN'T INCREASE IT.
>> ABSOLUTELY, THE TIMING
HYPOTHESIS --
>> WHICH IS REALLY INTERESTING
BECAUSE OF COURSE THAT'S WHERE
THIS WHOLE KERFUFLE
MPA MUST BE THE BAD PLAYER, I'M
NOT CONVINCED OF IT.
>> I AM.
>> AS ROBBIE SAYS, ALL THE
DIFFERENT FORMULATIONS AND I
THINK WE NEED DEFINITIVE STUDIES
TO ACTUALLY UNDERSTAND THAT.
I DON'T THINK THAT TISSUE
CULTURE STUDIES AND ANIMAL
STUDIES GIVE US THE ANSWERS.
WE'VE BEEN BURNED.
WE'VE BEEN BURNED WAY TOO MANY
TIMES.
>> I'LL BE STRICT TIME KEEPER
HERE AND GIVE DR. CRESWELL THE
LAST QUESTION AND WE'LL MOVE ON.
>> THIS HAS BEEN A GREAT PANEL.
I THINK ACTUALLY THIS
ILLUSTRATES SOME CHALLENGES
WE'RE GOING TO HAVE IN THE
WOMEN'S HEALTH RESEARCH
INITIATIVE AND ALSO IN ACHIEVING
THE GOALS DR. BERTAGNOLLI
OUTLINED.
I'LL USE OSTEOPOROSIS AS AN
EXAMPLE.
THERE WERE GREAT STRIDES IN
TERMS OF DECREASING FRACTURES
WITH BISPHOSPHONATE.
THERE WAS AN ARTICLE IN THE "NEW
YORK TIMES," AND THIS DRAMATIC
DECREASE IN USE, AND THEN THE
RATE OF FRACTURES STARTED
INCREASING.
HOW DO WE UNDERSTAND MORE ABOUT
THESE RARE SIDE EFFECTS WHICH
PEOPLE, ET CETERA, ARE RARE,
IT'S BEEN VIRTUALLY IMPOSSIBLE
TO STUDIES THESE IN A RIGOROUS
WAY SO THINGS TO SOLVE ON THAT
FRONT.
IN THE MEANTIME, VERY SOLID
EVIDENCE INDICATES THAT WOMEN
WHO ALREADY HAVE ONE
OSTEOPOROTIC FRACTURE, EXTREMELY
INCREASED RISK FOR HAVING A
SECOND, THIS HAS PROMPTED
MEDICAL CLINICAL TEAMS TO
DEVELOP FRACTURE LIAISON
SERVICES TO IDENTIFY THESE WOMEN
AT GREAT RISK IN THE HOSPITAL.
THE PROBLEM IS THOSE SERVICES
AREN'T REIMBURSED.
SO THERE'S BEEN THIS
LONGSTANDING EFFORT TO TRY TO
GET THAT REIMBURSED SO THIS CARE
THAT WE KNOW WILL MAKE A
DIFFERENCE CAN BE DELIVERED TO
PEOPLE.
WE HAVE ANOTHER PROBLEM, IF YOU
WANT TO DEVELOP NEW DRUGS TO
PREVENT OSTEOPOROSIS, IT TAKES A
LONG TIME TO OBSERVE OUTCOMES
LIKE WE WERE JUST DISCUSSING
HERE.
ARE THERE GOOD BIOMARKERS OR
PROXIES FOR FRACTURE?
THERE'S BEEN A LOT OF ADVOCACY,
LIKE A DECADE FOR THE FDA TO
APPROVAL ONE TRIAL TO USE BONE
MINERAL DENSITY AS A PROXY.
HERE'S A COMMON PROBLEM, SO
MULTI-FACTORIAL.
WE HAVE BIG CHALLENGES TO TRY TO
REALLY MAKE A DIFFERENCE IN
DELIVERING IMPROVED HEALTH TO
PEOPLE.
SO I THOUGHT THIS WAS A
FANTASTIC GROUP OF TALKS TO
ILLUSTRATE THE SCIENCE AS WELL
AS THESE BIGGER POLICY ISSUES.
THANK YOU FOR ORGANIZING THIS.
>> THANK YOU TO OUR SPEAKERS.
>> THANK YOU.
BRAVO.
IT WAS A GREAT PRESENTATION.
I'D LIKE TO INVITE DR. CLAYTON
TO INTRODUCE OUR NEXT SPEAKER.
>> LET ME ADD MY THANKS TO THE
PANELISTS, AND DR. DUTTA FOR AN
INCREDIBLE PANEL.
DR. CRISWELL HIGHLIGHTED
CHALLENGES, DR. ANDERSON ASKED
MANY QUESTIONS WE DON'T HAVE THE
ANSWERS TO.
THANK YOU ALL.
I'D LIKE TO INTRODUCE OUR NEXT
SPEAKER, DR. VICTORIA SHANMUGAM,
ORWH, I MENTIONED HER EARLIER
TODAY WHEN I INTRODUCED HER
JOINING ORWH LEADERSHIP, SHE'S A
PHYSICAL EXAMINATION SCIENTIST,
RHEUMATOLOGIST, HAS LED THE
RHEUMATOLOGY FELLOWSHIP AT
GEORGETOWN UNIVERSITY, ALSO WAS
FACULTY AT GEORGE WASHINGTON
UNIVERSITY.
AND I THINK WE'VE GOT HER SLIDES
CUED UP HERE IN ONE SECOND.
THERE WE GO.
>> THANK YOU.
WE SAVED THE BEST FOR LAST FOR
YOU.
SO, THANK YOU, EVERYONE.
THANKS FOR THE INTRODUCTION, DR.
CLAYTON.
I'M HERE TO PRESENT TODAY A
REQUEST FOR YOU TO VOTE ON A
POTENTIAL NOTICE OF SPECIAL
INTEREST, LOOKING TO BUILD
CONSENSUS FOR AUTOIMMUNE
DISEASE-RELATED COMMON DATA
ELEMENTS.
SO THIS WOULD BE A NEW CONCEPT
CLEARANCE, THE PURPOSE TO
HIGHLIGHT OUR INTEREST IN OFFICE
OF AUTOIMMUNE DISEASE RESEARCH,
APPLICABLE TO AUTOIMMUNE
DISEASES, AND TO REALLY USE THIS
TOOL TO CONVENE MEMBERS OF THE
SCIENTIFIC, CLINICAL, PATIENT,
AND ADVOCACY COMMUNITY TO INFORM
DISCUSSIONS AND IDENTIFY
APPROPRIATE COMMON DATA ELEMENTS
TO INCLUDE A MOVE TO
ENDORSEMENT, THIS WILL OBVIOUSLY
BE SUBJECT TO AVAILABILITY OF
FUNDS, AND COLLABORATION WITH
THE VARIOUS ICOS IN ORDER TO
MAKE THIS HAPPEN, AND IT'S
EXPECTED THESE WOULD EACH BE
AWARDED FOR ONE SINGLE YEAR.
WHAT WE'RE ASKING AFTER I
PRESENT IS A VOTE TO APPROVE THE
CONCEPT FOR BUILD CONSENSUS FOR
COMMON DISEASE RELATED ELEMENTS.
TO GIVE THE BACKGROUND, I FEEL
LIKE THE SPEAKERS THROUGHOUT
TODAY HAVE LINED ME UP NICELY
FOR THIS DISCUSSION, AS YOU KNOW
AUTOIMMUNE DISEASES ARE RATHER
COMMON.
APPROXIMATELY 7 TO 8% OF THE
POPULATION, ABOUT 23.5 MILLION
AMERICANS ARE AFFECTED BY
AUTOIMMUNE DISEASES, THAT'S
PROBABLY AN UNDERESTIMATE.
IN CONTEXT, AT THE END OF 2021,
THERE WERE 1.2 MILLION PEOPLE
LIVING WITH HIV IN THE UNITED
STATES.
SO 23.5 MILLION PEOPLE ALL
LIVING WITH AUTOIMMUNE
DISEASES.
80% ARE WOMEN, FOUR TIMES MORE
WOMEN THAN MEN ARE AFFECTED.
THE REALITY IS THAT THE EXACT
PREVALENCE OF AUTOIMMUNE
DISEASES IN THE U.S. IS UNKNOWN
BECAUSE WE DON'T HAVE ANY GOOD
LONGITUDINAL DATA REPOSITORY.
AND SO THIS IS FOUNDATIONAL
TOWARDS BUILDING THAT.
THIS IS THE LIST THAT OUR OFFICE
WAS GIFTED, AS WE BECAME
ESTABLISHED, LAST YEAR.
I APPRECIATE THE TYPE IS RATHER
SMALL.
IF YOU USE THE QR CODE IT WILL
TAKE YOU TO THE WEBSITE WHERE
THERE'S A LARGE PRINT VERSION.
THERE ARE 144 AUTOIMMUNE
DISEASES AND RELATED CONDITIONS
ON THIS LIST.
SO THERE IS A LOT OF NEED IN
THIS AREA.
JUST BY WAY OF BACKGROUND, NIH
ENDORSED COMMON DATA ELEMENTS,
STANDARDIZED PRECISELY DEFINED
QUESTIONS, PAIRED WITH A SET OF
RESPONSES USED SYSTEMICALLY
ACROSS DIFFERENT CLINICAL SITES,
STUDIES, CLINICAL TRIALS, TO
ENSURE CONSISTENCY OF DATA
COLLECTION AND DATA
HARMONIZATION.
THEY HAVE REALLY BEEN HARMONIZED
THROUGH A PROJECT AT THE
NATIONAL LIBRARY OF MEDICINE,
THIS CODE WILL TAKE YOU TO THEIR
WEBSITE TO ENSURE THAT THE NIH
IS ENDORSING COLLECTIONS OF
CDEs THAT MEET CRITERIA, AND
PURPOSE OF THAT IS REALLY TO BE
FOUNDATIONAL IN THIS FOCUS ON
DATA SHARING, SO WE CAN ACTUALLY
START TO BUILD BOTH LONGITUDINAL
REPOSITORIES FOR AUTOIMMUNE
DISEASE AND FACILITATE DATA
MANAGEMENT AND SHARING THAT
WE'RE TRYING TO ACHIEVE.
SO JUST AS THE BASELINE, THIS IS
THE CURRENTLY ENDORSED NIH
COMMON DATA ELEMENTS FOR
AUTOIMMUNE DISEASE RESEARCH.
I SHOWED 144 DISEASES, THIS IS
WHAT WE HAVE ENDORSED CURRENTLY.
MULTIPLE SCLEROSIS IS DOING
BETTER THAN MANY OTHERS, QR CODE
ON THIS SLIDE WILL TAKE YOU TO
THE SITE WHERE THEY HAVE HAD A
CONCERTED EFFORT TO BUILDING
COMMON DATA ELEMENTS IN MULTIPLE
SCLEROSIS AND IT'S BEEN AN
EFFORT GOING ON OVER THE COURSE
OF TEN YEARS THAT SET THEM UP
WELL FOR LONGITUDINAL STUDIES IN
MULTIPLE SCLEROSIS.
EMBARRASSINGLY THERE ARE VERY
FEW ENDORSED COMMON DATA
ELEMENTS FOR SOME MORE COMMON
AUTOIMMUNE DISEASES, INCLUDING
LUPUS, SCLERODERMA, VASCULITIS,
VITILIGO.
WE HAVE LOTS OF EXISTING
REGISTRIES FOR AUTOIMMUNE
DISEASE RESEARCH, YOU CAN'T FIT
THEM ALL ON A SINGLE SLIDE BUT
THEY RANGE FROM REGISTRIES
FOCUSED ON RHEUMATOID ARTHRITIS,
INFLAMMATORY BOWEL DISEASE,
REGISTRIES IN THE V.A.,
REGISTRIES FOCUSED ON CLINICAL
TRIALS, SO PART OF THE WORK WE
NEED TO DO IS TRYING TO
HARMONIZE DATA ELEMENTS TO MOVE
FORWARD IN TERMS OF ADVANCING
AUTOIMMUNE DISEASE RESEARCH.
TO GIVE BACKGROUND, I KNOW
YOU'VE HEARD ABOUT THIS
PREVIOUSLY, THE OFFICE OF
AUTOIMMUNE DISEASE RESEARCH WAS
ESTABLISHED LAST YEAR, ALIGNED
WITH CONTENT FROM THIS REPORT
WRITTEN BY NASEM IN 2022, AND
REALLY FOCUSED ON TRYING TO
ENHANCE THE NIH APPROACH TO
RESEARCH ON AUTOIMMUNE DISEASE,
TASKED WITH SIX THINGS THAT THE
CONGRESS HAD ASKED US TO DO, AND
I'M GOING TO HIGHLIGHT THE ONES
THIS PARTICULAR INITIATIVE WILL
FOCUS ON, PARTICULARLY
IDENTIFYING EMERGING AREAS OF
INNOVATION AND OPPORTUNITIES TO
SUPPORT RESEARCH, COORDINATING
AND FOSTERING COLLABORATEDDIVE
RESEARCH APPROACHES ACROSS THE
I.C.s, PROVIDING RESOURCES TO
SUPPORT PLANNING, COLLABORATION,
INNOVATION, AND THE SIXTH TO
DEVELOP PUBLICLY ACCESSIBLE
REPOSITORY, YOU CAN'T DO THAT
WITHOUT APPROACHING FROM A DATA
STANDPOINT.
SO, JUST TO SUMMARIZE AGAIN THIS
IS A REQUEST FOR THE COMMITTEE
TO VOTE ON A POTENTIAL NOTICE OF
SPECIAL INTEREST TO SUPPORT
BUILDING CONSENSUS FOR
AUTOIMMUNE DISEASE-RELATED
COMMON DATA ELEMENTS.
AGAIN, WE WERE LOOKING FOR
AWARDS WITH PROJECT PERIOD OF
ONE YEAR, AND WE ANTICIPATE
IDENTIFYING AREAS OF FOCUS
THROUGH OBVIOUSLY LITERATURE
REVIEW, INTERNAL, EXTERNAL
ENGAGEMENT, CONDUCTING A
PORTFOLIO ANALYSIS OF AUTOIMMUNE
DISEASE RESEARCH ACROSS NIH,
WE'RE EXPECTING WE WILL BE
SUPPORTIVE OF COLLABORATIVE
APPROACHES TO THIS CHALLENGE,
THERE'S BEEN A LOT OF I.C.
INTEREST IN SUPPORTING THIS AND
I'VE LISTED A FEW OF THE
PRIORITY DISEASE AREAS AS YOU
CAN SEE WITH 144 YOU CAN TAKE
YOUR PICK.
ONE LAST QR CODE IF YOU COULD
LIKE TO SIGN UP FOR OUR E-MAILS,
THIS WILL TAKE YOU TO THE E-MAIL
SIGN-UP.
WE HAVE A COUPLE SEMINARS THAT
THE AUDIENCE MIGHT BE INTERESTED
IN CLUES ONE ON XIST, AND
INCLUDING A SYMPOSIUM MAY 15.
THANK YOU FOR LISTENING.
I'LL BE HAPPY TO TAKE QUESTIONS.
>> A QUICK QUESTION.
WE LIKE TO FOCUS ON DISEASES.
WOULD IT BE WORTHWHILE TO FOCUS
ON PROCESSES, LONG ENCODING RNA
BASED ON EVERYTHING WE READ
RECENTLY?
>> YES.
WE'RE INTERESTED IN THAT
RESEARCH ALSO.
ONE OF THE AREAS THAT OUR OFFICE
IS INTERESTED IN LOOKING AT ARE
THINGS THAT CROSS BETWEEN
DIFFERENT ICO MISSION AREAS, AND
PERHAPS DON'T NECESSARILY FALL
INTO DISEASE AREAS, THAT LIST OF
DISEASES IS REALLY THE █LIST THT
WE'RE USING TO DO THIS INITIAL
PORTFOLIO ANALYSIS, , WHEN WE'RE
APPROACHING SUPPORTING
INFRASTRUCTURE FOR AUTOIMMUNE
DISEASE RESEARCH WE NEED TO
RECOGNIZE THE SCOPE OF WHAT
WE'RE BEING ASKED TO DO, AN
ENORMOUS LIFT.
>> MIGHT BE NICE TO EXPAND THE
SCOPE FROM THE PROCESS POINT OF
VIEW INCLUDING KEY PLAYERS,
EVERYBODY THINKS ABOUT IMMUNE
MECHANISMS, LONG ENCODING RNAs
LIKE EXIST IN OTHERS MAY BE
EXCITING.
>> YES.
WE'RE VERY EXCITED TOO, ALSO
OBVIOUSLY THE VARIOUS
ENVIRONMENTAL TRIGGERS, WE
TALKED ABOUT THE EXACT PLAN,
INAUGURAL AWARDS FROM OUR
OFFICE, TRYING TO INTEGRATE SOME
OF THIS DATA AND HOW DO YOU
UNDERSTAND INCLUDING AS WE
DESCRIBED ACROSS THE LIFESPAN,
TRANSITIONS IN PEOPLE'S BIOLOGIC
LIVES, WHEN DO THESE EXPOSURES
MATTER AND HOW DO THEY IMPACT
THE IMMUNE SYSTEM.
>> PLEASE.
>> I WANTED TO KNOW AS FAR AS
THE LIST OF CONDITIONS THAT ARE
HIGHLIGHTED, HOW DOES THAT LIST
REFLECT EITHER DISEASE BURDEN OR
MAYBE THE CURRENT PORTFOLIO
BEING FUNDED AND THOSE
CONDITIONS THAT MIGHT NOT HAVE A
LOT OF FUNDING CURRENTLY?
>> YEAH, SO WE OBVIOUSLY HAVE A
LARGE NUMBER OF DISEASES ON THE
LIST.
THE ONES I LISTED ON THE FINAL
SLIDE ARE JUST EXAMPLES.
SO, THIS WOULD BE SOMETHING THAT
WOULD BE AN OPEN COMPETITION FOR
APPLICATIONS, AND WE WOULD BE
SUPPORTIVE OF ANYTHING THAT'S
WELL REVIEWED.
>> OTHER QUESTIONS?
ANY QUESTIONS ON THE LINE?
OKAY.
AT THIS TIME WE'LL TAKE A VOTE
TO APPROVE THE NIH OFFICE OF
AUTOIMMUNE DISEASE RESEARCH
NOTICE OF SPECIAL INTEREST
CONCEPT CLEARANCE.
PLEASE NOTE THAT ONLY FULL
MEMBERS OF THE ADVISORY
COMMITTEE MAY VOTE.
AND IF YOU'RE AN AD HOC MEMBER,
OTHERWISE NOT A MEMBER OF ACRWH,
RESIST VOTING.
IS THERE A MOTION ON THE TABLE
TO APPROVE THE NOTICE OF SPECIAL
INTEREST?
>> SO MOVED.
>> DO I HAVE A SECOND?
>> I SECOND.
>> THANK YOU VERY MUCH.
SO ALL THOSE IN FAVOR OF
ACCEPTING THE MOTION PLEASE
RAISE YOUR HAND.
ALL THOSE OPPOSED TO THE MOTION
PLEASE RAISE YOUR HANDS NOW.
ALL THOSE ABSTAINING FROM THE
MOTION PLEASE NOW RAISE YOUR
HAND.
>> HAVE THE VOTES BEEN RECORDED?
>> YES, NINE IN FAVOR.
>> THANK YOU VERY MUCH.
THE NOTICE OF SPECIAL INTEREST
CONCEPT CLEARANCE HAS BEEN
ACCEPTED WITH NINE VOTES IN
FAVOR.
>> THANK YOU VERY MUCH.
>> THANK YOU, EVERYONE.
WE HAVE NOW REACHED OUR OPEN
DISCUSSION SESSION.
I WANTED TO MAKE SURE WE HAD
TIME FOR ADVISORY COMMITTEE
MEMBERS TO ASK ANY QUESTIONS
THEY MIGHT HAVE.
OR MAKE ANY COMMENTS THEY MIGHT
LIKE TO HAVE.
I'M GOING TO START ONLINE AND
JUST PUT DR. SHARPES AND DR.
TEMPLETON ON THE SPOT IF THEY
HAVE COMMENTS OR QUESTIONS
DURING THE MEETING OR TOPICS OF
INTEREST?
KIM?
>> THIS HAS BEEN AN AMAZING
MEETING.
I DON'T REALLY HAVE ANY
QUESTIONS ABOUT TODAY BUT I
WANTED TO THANK YOU AND YOUR
STAFF FOR THE OPPORTUNITY TO
SERVE ON THIS ADVISORY COMMITTEE
AND I APPRECIATE THE OPPORTUNITY
TO WORK WITH THE OTHER MEMBERS
OF THE COMMITTEE AND I HOPE OUR
PATHS CROSS AGAIN IN THE FUTURE.
THANK YOU VERY MUCH FOR THE
GREAT FOUR YEARS.
>> THANK YOU, DR. TEMPLETON.
DR. SHARPES, ANY COMMENTS?
>> YES, I WANTED TO SAY, IT'S
BEEN SAID ALREADY, THE STRATEGIC
PLAN IS VERY WELL WRITTEN AND
I'M VERY PROUD TO HAVE
CONTRIBUTED TO IT, AND ALL OF
THE PRESENTATIONS WERE
OUTSTANDING TODAY.
I HAVE NO QUESTION.
>> THANK YOU, PHYLLIS.
LET'S GO TO THE ROOM.
DR. NOEL, I'LL PUT YOU ON THE
SPOT IN A MINUTE AFTER I ASK
ABOUT THE QUESTION WITH THE HAND
RAISED.
>> THANK YOU.
REALLY EXCITING.
I'M FINISHING MY TERM ON THE
COUNCIL, THANK YOU VERY MUCH.
TERRIFIC.
ONE OF THE WAYS TO JUDGE A GOOD
INVOLVEMENT, GOOD ENGAGEMENT FOR
ME NOT HOW MUCH I CONTRIBUTE
ONLY BUT OF COURSE IT'S
IMPORTANT, HOW MUCH I LEARN.
I LEARN AT EVERY MEETING, SO
THANK YOU VERY, VERY MUCH.
ONE BRIEF COMMENT.
REALLY AN EXCITING DAY.
ALL THE INITIATIVES WE HEARD
ABOUT IN THE LAST WEEKS AND
MONTHS IN WOMEN'S HEALTH ARE
REALLY TERRIFIC, LONG TIME
WAITING BUT FINALLY COMING TO
FRUITION.
I MAY NOT OBSERVE IT ON COUNCIL
BUT FROM THE OUTSIDE.
WITH ALL THE EXCITEMENT, I WANT
TO MAKE SURE WE DON'T FORGET THE
OTHER THINGS WE'VE BEEN
DISCUSSING FOR SEVERAL YEARS,
FRONT AND STERILE ON STRATEGIC
PLAN -- FRONT AND CENTER ON
STRATEGIC PLANNING, INFANT
MATERNAL, MATERNAL HEALTH IN
PREGNANCY, ALL THE THINGS WITH
ARPA-H WE DON'T FORGET THOSE
ISSUES.
REPRESENTING COMMUNITY, MANY
PEOPLE ARE ASKING WHAT DO WE
NEED TO DO TO MAKE SURE KEY
THINGS WE'VE BEEN DISCUSSING
SADLY WENT UP DURING THE
PANDEMIC, THOSE ARE NOT LOST
WITH THE EXCITEMENT.
>> THANK YOU SO MUCH FOR YOUR
COMMENT AND YOUR SERVICE ON THE
ADVISORY COMMITTEE.
MA
MATERNAL HEALTH IS INTEGRAL,
WHEN YOU CONSIDER LIFE COURSE
PERSPECTIVE WE NEED TO MAKE SURE
IT'S PART OF WHAT WE'RE DOING.
WE CAN'T STOP THERE.
WE'RE BUILDING A BIGGER PIE.
WE WILL CARRY THAT WITH YOU AND
OUR COLLEAGUES AT THE EUNICE
KENNEDY SHRIVER INSTITUTE OF
CHILD HEALTH AND HUMAN
DEVELOPMENT ARE THE LEADERS IN
MATERNAL HEALTH BASE AND WE
ENJOY WORKING WITH THEM ON
IMPROV E.
THANK YOU FOR YOUR SERVICE.
>> INTERESTINGLY I HAD A RELATED
QUESTION.
I THOUGHT THIS SESSION WAS
GREAT, REALLY INFORMATIVE.
I THINK THE REPORTS WERE WELL
PRESENTED AND EVERYTHING.
SO, GOOD DAY IN GENERAL.
I HAD A QUESTION ALSO RELATED TO
INCREASED MATERNAL MORTALITY
THAT WE SEE WITHIN
UNDERREPRESENTED GROUPS.
NOW THAT THE INFORMATION IS OUT
THERE, THE NUMBERS ARE THERE TO
SUPPORT WHAT -- I DON'T WANT IN
YEARS TO STILL HAVE THE SAME
CONVERSATION WITH THE SAME
NUMBERS.
WHAT IS CURRENTLY BEING
IMPLEMENTED IN ORDER TO MODIFY
THE RISK UNDERREPRESENTED
COMMUNITIES COULD BE DONE WITH
GUIDELINES, PHYSICIANS ATTENDS
TO THE PATIENTS, OR SOMETHING
THAT NEEDS MORE RESEARCH, HOW
COULD WE GO FROM, FOR EXAMPLE,
THE SCIENCE TO REALLY THE
BEDSIDE AND BRING THE SCIENCE TO
THE PEOPLE?
>> THANK YOU FOR THOSE COMMENTS
AND QUESTION.
I DO THINK THE IMPLEMENTING THE
PREGNANCY OUTCOMES FOR EVERYONE,
THE "IMPROVE" INITIATIVE, DOES
ADDRESS HEALTH DISPARITIES AND
RACE AND ETHNICITY DATA THAT YOU
HAVE OUTLINED AND DR.
BERTAGNOLLI MENTIONED, THESE
DIFFERENTIAL RATES, BUT LOOKING
AT A VARIETY OF FACTORS, SOCIAL
DETERMINANTS OF HEALTH AND OTHER
STRUCTURAL FACTORS TO BE ABLE TO
ADDRESS THEM, IT MAY BE HELP
FOLLOW HAVE AN UPDATE ON IMPROVE
AT A FUTURE MEETING SO YOU CAN
SEE THE WORK AT THE CENTERS OF
EXCELLENCE NOW THAT SEVERAL ARE
FUNDED AS WELL AS WORK WE'RE
SUPPORTING WITH NIGM NIGMS AND
THE IDeA STATES.
I MENTIONED POSTPARTUM HEALTH
P2P, WE HAVE A SYSTEMATIC
EVIDENCE REVIEW, FEDERAL
PARTNERS AND INDEPENDENT PANEL,
LOOK THERE FOR POTENTIAL ACTION
SEVERAL FEDERAL AGENCIES TALKED
ABOUT TO ADDRESS THESE ISSUES.
MUCH MORE WORK TO BE DONE.
I KNOW INDIVIDUALS LIKE YOURSELF
AND OTHERS WILL KEEP OUR FEET TO
THE FIRE UNTIL WE CAN REALLY
MOVE THIS FORWARD ON A NATIONAL
LEVEL.
I APPRECIATE THE INPUT.
ANY OTHER QUESTIONS OR COMMENTS?
>> THIS GOES BACK TO THE
BEGINNING.
THANK YOU SO MUCH FOR YOUR
REPORT.
HE TALKED ABOUT ALCOHOLISM AND
RELATED DISEASES AND IT CAME UP
LATER DISCUSSING SMOKING AND HOW
THAT BEING A RISK FACTOR WE
FOCUSED ON.
WE HAVE SEEN CONDITIONS THAT
AFFECT WOMEN, ALCOHOL USE FLOATS
TO THE TOP.
ARE THERE PLANS FOR NIH OR ORWH
TO ELEVATE THAT IN THE RESEARCH
PLAN AND STUDYING AUTOIMMUNE OR
OUGHT CONDITIONS?
>> SO THE NIAAA HAS A FOCUS ON
SEX DIFFERENCES IN WOMEN, THEY
HAD WORKSHOPS ON ALCOHOLISM, NOW
A MODEL CONTINUUM OF CARE
INITIATIVE, SPECIFICALLY
ADDRESSING LIFE COURSE AND
HEALTH OF WOMEN WITH ALCOHOL
USE.
IT'S A PLANNING GRANT AT THIS
POINT.
I DO EXPECT TO SEE MORE COMING
OUT OF THAT.
IN THE MENTAL HEALTH SUBSTANCE
USE, ALL SUBSTANCES SPACE, NIDA
ALSO HAS A VERY CLEAR INTEREST
IN SEX DIFFERENCES.
AND THROUGH OUR SCORE WE HAVE
SEVERAL SCOREs IN THAT SPACE.
SO I WOULD SAY STAY TUNED FOR
THE MODEL CONTINUUM OF CARE
INITIATIVE AS THE NEXT NEW THING
AND NIAAA AND DR. KOOB HAVE BEEN
ACTIVE ELEVATING THESEI.
AS WE LAUNCH THE NEXT STRATEGIC
PLAN FOR WOMEN'S HEALTH RESEARCH
WE EXPECT TO BE COLLABORATING.
YOU HEARD FROM DR. BERTAGNOLLI
SHOW WANTS TO WORK ACROSS SILOS
AND ELIMINATE SILOS, NIMH, NIDA
AND NIAAA ARE ALL INTERESTED IN
THESE ISSUES.
SO WE'D LIKE TO CONTINUE TO
STIMULATE ATTENTION TO
SCIENTIFIC SYNERGIES THAT COULD
BE ADDRESSED BY LOOKING AT THE
HEALTH OF WOMEN AS A CENTRAL
POINT.
>> SO THIS IS ALSO MY LAST
MEETING.
MY ONLY IN-PERSON MEETING.
I STARTED MY TERM DURING THE
PANDEMIC.
AND I DON'T KNOW, I GOT USED
TO -- I WANT TO GIVE AN OVERVIEW
OF MY EXPERIENCE ON THIS
COMMITTEE, I GOT USED TO BEING
INSPIRED BY DR. CLAYTON.
THAT BECAME -- I EXPECTED THAT.
I DON'T KNOW, TODAY REALLY TOOK
THE CAKE THOUGH.
I MEAN, EVERY SINGLE TALK WAS
INSPIRING, TO HEAR A WOMAN AS
THE NIH DIRECTOR, SOMEONE I'VE
KNOWN FOR A LONG TIME AND
RESPECT IN THE FIELD OF
ONCOLOGY, SPEAK SO COMPELLINGLY
ABOUT HOW IT'S NOT ENOUGH JUST
TO MAKE THE DISCOVERIES, WE HAVE
TO SEE IT TRANSLATE INTO
IMPROVED HEALTH.
I'M SO INVIGORATED TO SEE OUR
POLITICAL SYSTEM, PRIORITIZING
THE HEALTH OF WOMEN, TO HEAR THE
AMAZING PANELIST, IT'S VERY RARE
THAT I RETHINK MY LIFE CHOICES.
I DON'T WANT TO DO YOUR
RESEARCH.
IT'S SO FASCINATING, SO
INSPIRED, THE TIME WAS OVER TOO
FAST.
THANK YOU FOR LETTING ME DO
THIS.
>> THANK YOU.
YOU'VE BEEN A GREAT COMMITTEE
MEMBER AND I CAN'T BELIEVE THIS
IS THE FIRST IN-PERSON MEETING.
FEELS LIKE WE'VE BEEN DOING THIS
IN PERSON, YOU KNOW, WE
APPRECIATE THE KIND WORDS.
AND I AGREE WITH YOU, THE
SPEAKERS AND TOPIC IS CRITICAL.
IT'S INSPIRING TO SEE OTHER
PEOPLE RECOGNIZING HOW IMPORTANT
IT IS TO THE HEALTH OF THE
NATION.
SO FOR THAT I'M GRATEFUL.
DR. HIGGINS?
>> I WANT TO BUILD ON THAT
SINCERELY.
THIS IS ALMOST THROUGH MY 38th
YEAR OF NIH RESEARCH, AND
MEETINGS LIKE THIS.
I DON'T THINK I'VE EVER BEEN AT
A ONE-DAY MEETING THAT WAS
BETTER THAN THIS ONE, THE
QUALITY WAS JUST AMAZING.
I JUST FELT LIKE I WAS SO LUCKY
TO SIT HERE LISTENING TO THE
PRESENTATIONS, AND WITHOUT
EXCEPTION, SO GREAT JOB ON THIS.
AND HOPEFULLY I GET TO COME TO A
COUPLE MORE IN-PERSON MEETINGS.
>> THANK YOU.
DR. ANDERSON?
>> YEAH, IT'S BEEN A GREAT
MEETING.
I WANTED TO PUT A COUPLE OTHER
TOPICS ON TO MAKE SURE THAT WE
PAY ATTENTION, HEALTH OF
ADOLESCENTS, MENARCHE AND
OTHERS, THESE YOUNG WOMEN ARE
SUFFERING.
ON THE OTHER EXTREME, OUR AGING
WOMEN, AND THINKING ABOUT
CAREGIVING, ESPECIALLY.
THE BURDENS OF CAREGIVING AND
ITS IMPACT ON THEIR HEALTH IS
REALLY IMPORTANT AND SO I'D LIKE
TO MAKES SURE THAT'S ADDRESSED.
>> THANKS.
MUSCULOSKELETAL ISSUES HAVE BEEN
MENTIONED AT BOTH ENDS OF THE
EXTREME AS CRITICALLY IMPORTANT.
OTHER COMMENTS?
>> I WON'T BE THE ONLY ONE WHO
DOESN'T COMMENT, I'LL DITTO WHAT
EVERYONE SAID.
IT'S BEEN A MAGNIFICENT DAY.
THANK YOU.
ALSO JUST TO REINFORCE LOOKING
AT CAREGIVERS AND THEIR HEALTH,
SINCE THE MAJORITY OF CAREGIVERS
ARE WOMEN, YOU'VE HEARD THAT
BEFORE.
IT WOULD BE NICE TO SEE SOME
ACTION IN THAT MOVING FORWARD.
>> I THOUGHT YOU WERE GOING TO
MENTION PHYSICAL ACTIVITY,
ANOTHER IMPORTANT TOPIC.
ALEXANDER?
>> I WANTED TO ASK, YOU DIDN'T
TOUCH ON IT BUT FOR SEX AS A
BIOLOGICAL VARIABLE, IN GRANTS,
RESEARCHERS HAVE TO PUT BOTH,
BUT WHEN IT'S REPORTED IN
LITERATURE IF THEY DIDN'T SEE
MAJOR SEX DIFFERENCE THEY WILL
PULL THE DATA OF MEN AND WOMEN
TOGETHER.
IS IT POSSIBLE TO MENTION
SOMEWHERE THAT IT HAS TO BE
DEAGGREGATED DATA FOR MALE AND
FEMALE ONCE IT GETS TO
PUBLICATION?
I THINK AS SCIENTISTS WE MAY BE
MISSING A LOT.
I'M TALKING ABOUT BASIC SCIENCE
HERE, I'M SURE HUMAN DATA IS
PROBABLY MEN AND WOMEN BUT I
KNOW WHEN IT COMES TO ANIMAL
MODELS, SOMETIMES THE DATA COULD
BE AGGREGATED FOR BOTH SEXES AND
I THINK WE'RE MISSING SOMETHING
THERE.
>> THANK YOU FOR BRINGING UP
SABV, DR. NOEL.
WE'LL TALK ABOUT THE GOOD NEWS,
ON THE CLINICAL SIDE, YOU'RE A
BASIC SCIENTIST, BUT ON THE
CLINICAL SIDE WE HAVE SEEN AN
INCREASE IN REPORTING OF SEX
DISAGGREGATED RESULTS FOR PHASE
3 CLINICAL TRIALS GOING FROM 27,
29% FIVE OR TEN YEARS AGO TO
43%, SUBSTANTIAL INCREASE, .
GUIDELINES HAVE BEEN ADOPTED FOR
MANY JOURNALS, THE ICMJE ADOPTED
GUIDELINES AS WELL AS
ENCOURAGING THEM BUT IT IS
HIGHLY VARIABLE ACROSS
DISCIPLINES AND FIELDS ON THE
BASIC SCIENCE AND PRE-CLINICAL
RESEARCH SIDE.
THE POLICY WE DO NOT CONTROL
JOURNAL EDITORS AND THEIR
EDITORIAL POLICIES.
HOWEVER, WE ARE WORKING ON WAYS
TO WORK WITH JOURNAL EDITORS AND
PUBLISHERS TO CONTINUE TO
DEMONSTRATE HOW IMPORTANT IT IS
TO DO SO.
AS YOU SAID, TO DERIVE
SCIENTIFIC INSIGHTS AND TO
MAXIMIZE WHAT YOU LEARN FROM
EVERY EXPERIMENT IN EVERY STUDY.
KEEP ASKING US ABOUT THAT.
WE'RE DOING SOME INTERNAL STEPS
AND HOPEFULLY I'LL BE ABLE TO
SHARE MORE WITH YOU AT THE NEXT
MEETING.
IRENE?
>> I DID WANT TO ACTUALLY
DOVETAIL ON BIT TO COMMEND ORWH.
YOU BROUGHT UP SABV.
IT'S AN OLD TOPIC PER SE BUT THE
FACT THAT YOU HAVE STUCK WITH
ENGAGING FORMER WINS TO MAKE
SURE THEY DON'T FALL OFF AS WE
PROGRESS THROUGH.
IT'S A LOT BECAUSE YOU KEEP
ADDING MORE AND MORE WORK TO THE
PLATE BUT I REALLY COMMEND ORWH
FOR STICKING WITH TOPICS OVER
THE YEARS AND HAVING THAT IMPACT
AND MAKING SURE THAT YOU DON'T
ALLOW IT TO FALL TO THE WAYSIDE
AS YOU TAKE ON MORE WORK.
>> THANK YOU SO MUCH, IRENE.
LAST COMMENTS BEFORE WE ADJOURN?
I DO WANT TO THANK ALL OF THE
AMAZING -- OOPS, WAIT, WAIT,
WAIT.
WHO IS ONLINE, IS THAT DR. SIMON
IN A CAB?
OKAY, DR. SIMON, I SEE YOU.
GO RIGHT AHEAD.
>> I'M NOT IN A CAB NOW.
I JUST GOT OUT.
I'M IN THE AIRPORT.
AGAIN, THANK YOU.
I ECHO EVERYONE'S POSITIVE
COMMENTS, AMAZING MEETING.
I JUST WANT TO KNOW IF MAYBE
NEXT TIME OR THE FOLLOWING TIME
AS WE -- AS YOU ALL PUT OUT MORE
OF THESE SPECIFIC REQUESTS FOR
PROPOSALS, NOW YOU HAVE THE
NOSI, THAT'S ACROSS ANY, ARE WE
-- NIH, ARE WE GOING TO LOOK AT
DATA, WHO GETS FUNDED, ARE THEY
EARLY CAREER INVESTIGATORS, KIND
OF LIKE AN OVERVIEW TO GET A
SENSE OF WHAT KIND OF RESEARCH
IS BEING FUNDED UNDER SPECIFIC
RFAs, ALSO FOR THE NOSI WHAT
KINDS OF RESEARCH IS BEING
FUNDED.
JUST HOPE WE CAN SEE HOW WE'RE
DOING.
>> THANK YOU, DR. SIMON.
ABSOLUTELY UNDERSTAND THAT YOU
WANT TO BETTER BE ABLE TO
CHARACTERIZEED INVESTIGATORS AND
APPLICANTS FOR WOMEN'S HEALTH
RELEVANT FUNDING OPPORTUNITIES
ACROSS NIH, AN EXCITING WITH THE
OPPORTUNITY WITH THE NOSI
THERE'S MORE DATA.
AN IMPORTANT THING TO LOOK AT
ESPECIALLY LOOKING AT EARLY
DECISION INVESTIGATORS, NEW
INVESTIGATORS, AND JUST
CHARACTERIZING DEMOGRAPHICS OF
THAT INVESTIGATOR POOL.
>> AND THE TOPICS.
>> AND TOPICS.
HAPPY TO LOOK INTO THAT.
>> THANK YOU.
>> ANYTHING ELSE?
>> DR. JONES HAD TO LEAVE EARLY
TO MAKE SURE SHE'S NOT ONLINE
THERE.
WITH THAT, AGAIN, I WANT TO TAKE
ALL THE SPEAKERS, ALL THE
PRESENTERS, ALL OF THE ADVISORY
COMMITTEE MEMBERS FOR YOUR
INCREDIBLE WORK FOR ORWH AND FOR
WOMEN'S HEALTH RESEARCH.
I WANT TO ACKNOWLEDGE DR. OTA
WANG, EXEC SEC AND INCREDIBLE
TEAM OF FOLKS BEHIND THE SCENES,
BEHIND THE CURTAIN, WHO MADE
SURE YOU WERE HERE, WHO MADE
SURE THE SLIDES WERE HERE, ALL
OF OUR FEDERAL EMPLOYEES,
COMMUNICATIONS TEAM, LOGISTICAL
SUPPORT TEAM, CONTRACTORS,
EVERYONE WHO SUPPORTED TODAY.
THANK YOU VERY MUCH.
INCLUDING THE COMS TEAM WHO GETS
THE WORD OUT.
SAFE TRAVELS HOME.
WE'LL SEE ON YOU OCTOBER 16 FOR
THE 61st MEETING, WE'RE NOW
ADJOURNED.
THANK YOU VERY MUCH.
[END OF PROGRAM]