>> GOOD MORNING, AND WELCOME.
I'D LIKE TO CALL TO ORDER THE
61ST MEETING OF THE NIH ADVISORY
COMMITTEE ON RESEARCH ON WOMEN'S
HEALTH.
MY NAME IS VIVIAN OTA WANG AND
I'M THE ORWH DEPUTY DIRECTOR AND
EXECUTIVE SECRETARY OF THIS
COMMITTEE.
THIS MEETING IS OPEN TO THE
PUBLIC BY BROADCAST ON THE NIH
VIDEOCAST NETWORK, AND IT'S
BEING RECORDED.
FOR OUR ARCHIVES AND FOR FUTURE
ON-DEMAND VIEWING FOR THE
PUBLIC.
IF YOU ARE A MEMBER OF THE
PUBLIC, PER THE FEDERAL REGISTRY
NOTICE, YOU MAY SUBMIT YOUR
QUESTIONS IN WRITING TO ME AT
ACRWH@NIH.GOV, AND WE WILL
ADDRESS QUESTIONS AFTER THE
MEETING.
THE MEETING IS HYBRID.
THE ADVISORY COMMITTEE AND OUR
INVITED GUEST PRESENTERS ARE
PARTICIPATING IN PERSON AND
THROUGH ZOOM.
SO NOW A MESSAGE FOR OUR MEMBERS
WHO ARE SITTING WITH US TODAY.
THIS IS REALLY JUST A REMINDER
BECAUSE YOU ARE SPECIAL
GOVERNMENT EMPLOYEES.
AS A MEMBER OF THIS FEDERAL
ADVISORY COMMITTEE, YOU ARE
FEDERAL GOVERNMENT EMPLOYEES,
WHICH MEANS YOU'RE SUBJECT TO
THE SAME ETHICS RULES THAT APPLY
TO GOVERNMENT EMPLOYEES.
THESE RULES ARE DESCRIBED IN THE
PAMPHLET TITLED STANDARDS OF
ETHICAL CONDUCT FOR EMPLOYEES OF
THE EXECUTIVE BRANCH.
YOU RECEIVED A COPY OF THIS
DOCUMENT WHEN YOU WERE APPOINTED
AND AT EVERY MEETING, WE'D LIKE
YOU TO REVIEW THE STEPS WE TAKE
AND THE PROCESSES WE FOLLOW TO
IDENTIFY AND ADDRESS ANY
CONFLICTS BETWEEN YOUR PUBLIC
RESPONSIBILITIES WITH US AND
YOUR PRIVATE INTERESTS.
AS YOU KNOW BEFORE EVERY
MEETING, YOU PROVIDE US A GREAT
DEAL, AND I DO KNOW IT'S A GREAT
DEAL ABOUT YOUR INFORMATION
ABOUT YOUR PROFESSIONAL AND
PERSONAL FINANCIAL INTERESTS.
WHAT WE DO IS WE USE THIS
INFORMATION AS A FOUNDATION FOR
ASSESSING WHETHER YOU HAVE ANY
REAL OR POTENTIAL OR APPARENT
CONFLICTS OF INTEREST THAT COULD
POTENTIALLY COMPROMISE YOUR
ABILITY TO BE OBJECTIVE IN
GIVING US ADVICE DURING OUR
COMMITTEE MEETING.
IF THERE IS -- YOUR INDIVIDUAL
SERVICES OUTWEIGHS THE POTENTIAL
CONFLICTS OF INTEREST THAT WE
IDENTIFIED, WE WOULD ISSUE A
WAIVER OR RECUSE YOURSELF FOR A
PARTICULAR PORTION OF THE
MEETING.
WE USUALLY WAIVE CONFLICTS OF
INTEREST FOR GENERAL MATTERS
BECAUSE YOUR ABILITY TO BE
OBJECTIVE WILL NOT BE AFFECTED
BY YOUR FINANCIAL INTERESTS.
WE ALSO RELY A GREAT DEAL ON YOU
AND ALSO A GREAT DEAL ON YOU.
ALSO WE REALLY HAVE APPRECIATED
ABOUT YOU BEING ATTENTIVE DURING
THE MEETINGS AND THE POSSIBILITY
THAT ISSUES COULD ARISE THAT
COULD AFFECT OR APPEAR TO AFFECT
YOUR FINANCIAL INTERESTS, AND IF
THAT HAPPENS, IF YOU COULD
RECUSE YOURSELF, THAT WOULD BE
APPRECIATED.
BEFORE THE INTRODUCTIONS I JUST
WANT TO BRIEFLY REVIEW SOME OF
OUR BEST PRACTICES THAT WE HAVE
FOR THIS HYBRID MEETING.
FIRST PLEASE MUTE YOUR
MICROPHONE WHEN YOU AREN'T
SPEAKING, AND IMPORTANTLY, WHEN
SPEAKING, PLEASE STATE YOUR NAME
BEFORE MAKING COMMENTS, MOTIONS
OR RECOMMENDATIONS.
IF YOU'RE IN PERSON, PLEASE MAKE
SURE YOUR MICROPHONE IS ON WHEN
SPEAKING AND PLEASE REFRAIN FROM
DRAGGING THE MICROPHONE ACROSS
THE TABLE.
WE'VE HEARD IT MAKES AN
INCREDIBLE SOUND THAT WE REALLY
DO NOT WANT TO HEAR.
AND FOR THOSE OF YOU WHO TEND TO
LEAN BACK WHEN YOU'RE SPEAKING,
WE'RE GOING TO HAVE YOU TRY TO
LEAN INTO THE MICROPHONE SO WE
WON'T MISS ANY WORDS THAT YOU'RE
SAYING.
IF YOU'RE ONLINE, PLEASE TRY TO
USE THE HEADSET WITH A
MICROPHONE WHEN SPEAKING.
WE FIND THIS REALLY RESULTS IN A
CLEAR SOUND AND PROVIDES THE
LEAST AMOUNT OF AUDIO FEEDBACK
FOR THE RECORDING.
IMPORTANTLY IF YOU HAVE ANY
QUESTIONS OR WOULD LIKE TO MAKE
A COMMENT, PLEASE RAISE YOUR
HAND.
AND WHEN INDICATED, MEMBERS WILL
VOTE BY RAISING THEIR HANDS.
WE WILL TAKE VOTES TO ACCEPT,
REJECT, OR ABSTAIN SEPARATELY,
SO PLEASE RAISE YOUR HAND IN
ACCORDANCE WITH YOUR RESPONSE.
FOR ONLINE ATTENDEES, WE WILL
SHARE YOUR VOTES IN THE ZOOM
GALLERY DURING THE TIME WHEN
WE'RE VOTING.
SO AS I GO THROUGH THE ROSTER,
WHEN YOU HEAR YOUR NAME, COULD
YOU PLEASE UNMUTE YOUR MIC AND
INTRODUCE YOURSELF BY NAME AND
WHAT INSTITUTION YOU REPRESENT.
I'M HOPING YOU SIGNED IN AT THE
SHEET AT THE FRONT TABLE.
IF NOT, PLEASE DO SO BEFORE THE
END OF THE DAY.
OKAY.
SO LET'S GO WITH SOME
INTRODUCTIONS HERE.
FIRST I JUST WANT TO ACKNOWLEDGE
THAT WE WANT TO THANK SOME ACRWH
MEMBERS RETIRING IN THE COMING
MONTHS.
THEY'VE SERVED DILIGENTLY AS YOU
ALL KNOW FOR THE PAST FOUR
YEARS.
DR. MELISSA SIMON, DR. IRENE
ANINYE, AND DR. GARNET ANDERSON.
SO IF WE COULD GIVE A WARM
APPLAUSE AND THANK YOU FOR ALL
YOUR SERVICE.
I WOULD ALSO LIKE TO RECOGNIZE
OUR NEW MEMBERS WHO HAVE JOINED
US TODAY.
DR. AYUSH GIRI AND
DR. IGHOVWERHA OFOTOKUN.
YOU GET APPLAUSE TOO.
OKAY.
NEXT SLIDE, PLEASE.
I ALSO WANT TO RECOGNIZE SOME
UPCOMING ACRWH MEMBERS.
SOME OF THESE MEMBERS HAVE
ACTUALLY JOINED US TODAY AS AD
HOC MEMBERS.
IT'S DR. ARTHUR ARNOLD,
DR. LAPRINCESS BREWER AND
DR. ROSALYN MABEN-FEASTER.
SO YOU GET APPLAUSE AS WELL.
AND FINALLY, WE WOULD LIKE TO
THANK SOME OF OUR ACRWH MEMBERS
FOR THEIR CONTINUED SERVICE.
AND THEY INCLUDE DR. RESHMA
JAGSI AND DR. KIMBERLY TEMPLETON
WHO'S ACTUALLY ON THE PHONE
TODAY WITH US.
THANK YOU VERY MUCH.
OKAY.
SO I WILL SAY MY PAGES GOT OUT
OF ORDER.
SO I'M BACKTRACKING A LITTLE
BIT.
SO WHAT WE WANT TO DO NEXT IS
REALLY GO AROUND THE ROOM AND
EVERYONE DO THEIR INTRODUCTIONS.
SO I'LL JUST START CALLING
PEOPLE AND IF YOU STATE YOUR
NAME AND YOUR AFFILIATION.
DR. ANDERSON.
>> GOOD MORNING.
I'M GARNET ANDERSON.
I REPRESENT THE FRED HUTCH SON
CANCER RESEARCH CENTER.
>> THANK YOU.
DR. ANINYE.
>> GOOD MORNING.
I'M DR. IRENE ANINYE AND I
REPRESENT THE SOCIETY FOR
WOMEN'S HEALTH RESEARCH.
>> THANK YOU.
DR. ARNOLD.
>> MORNING.
I'M ART ARNOLD.
I'M AT THE UNIVERSITY OF
CALIFORNIA-LOS ANGELES.
>> DR. BREWER.
IS DR. BREWER ONLINE?
OKAY, WE WILL CONTINUE.
DR. GIRI.
>> HI, I'M DR. AYUSH GIRI,
VANDERBILT UNIVERSITY MEDICAL
CENTER.
>> THANK YOU.
DR. HIGGINS.
>.DR. JAGSI.
>> I'M RESHMA JAGSI, EMORY
UNIVERSITY SCHOOL OF MEDICINE.
>> THANK YOU.
DR. JONES?
>> GOOD MORNING.
MY NAME IS DR. HENDREE JONES,
REPRESENTING UNIVERSITY OF NORTH
CAROLINA CHAPEL HILL.
>>
>> GOOD MORNING, ROSALYN
MAEBEN-FEASTER, UNIVERSITY OF
MICHIGAN MEDICAL SCHOOL.
>> DR. MIELENZ.
>> GOOD MORNING, THELMA MIELENZ
FROM COLUMBIA UNIVERSITY.
>> THANK YOU.
DR. NOEL.
>> GOOD MORNING.
ALEXANDRA NOEL, LOUISIANA STATE
UNIVERSITY.
>> DR. SHARPS.
>> GOOD MORNING.
I'M DR. SHARPS FROM JOHNS
HOPKINS UNIVERSITY SCHOOL OF
NURSING.
>> THANK YOU.
DR. SIMON?
>?AND DR. TEMPLETON.
>> I'M KIM TEMPLETON FROM
UNIVERSITY OF KANSAS IN KANSAS
CITY.
>> AND DR. OFOTOKUN.
>> THANK YOU.
GOOD MORNING.
MY NAME IS IGHO OFOTOKUN FROM
EMORY UNIVERSITY SCHOOL OF
MEDICINE.
>> I WILL GET BETTER WITH YOUR
NAME.
I MAY HAVE TO REHEARSE IT A
LITTLE BIT MORE.
SORRY, I'M A LITTLE -- OKAY.
NOW WE'RE UP TO OUR MINUTES.
SO YOU WERE EACH SEPTEMBER THE
MSEPTEMSENT THE MINTSFROM APRIL.
PLEASE NOTE THAT ONLY FULL MEMO
WMEMBERS OF THE ADVISORY
COMMITTEE MAY VOTE.
IF YOU ARE NOT A MEMBER OF ACRWH
AS A FULL MEMBER, WE ASK THAT
YOU REFRAIN FROM VOTING.
SO IS THERE A MOTION ON THE
TABLE TO ACCEPT THE APRIL 9TH,
2024 MINUTES AS WRITTEN?
DR. NOEL HAS SUBMITTED THE
MOTION.
DO I HEAR A SECOND?
>> I'LL SECOND.
>> DR. JONES HAS SECONDED THE
MOTION.
ALL THOSE IN FAVOR OF ACCEPTING
THE MOTION, PLEASE RAISE YOUR
HANDS NOW.
AND ONLINE?
>> AYE.
>> THANK YOU.
FOR THOSE WHO OPPOSE THE MOTION,
PLEASE RAISE YOUR HANDS NOW.
AND ALL THOSE ABSTAINING FROM
THE MOTION, PLEASE RAISE YOUR
HANDS NOW.
THANK YOU.
HAVE THE VOTES BEEN RECORDED?
THANK YOU VERY MUCH.
SO AS YOU HEARD THE APRIL 9TH,
2024 MEETING MINUTES HAVE BEEN
ACCEPTED WITH 10 MEMBERS IN
FAVOR.
NEXT SLIDE.
NOW I'D LIKE TO INTRODUCE THE
CHAIR OF THE COMMITTEE AND THE
DIRECTOR OF ORWH, DR. JANINE
CLAYTON.
>> GOOD MORNING, EVERYONE.
IT GREAT TO BE WITH YOU FOR
ANOTHER ADVISORY COMMITTEE FOR
RESEARCH ON WOMEN'S HEALTH
MEETING, OUR 61ST MEETING, AND
WE'RE LOOKING FORWARD TO A
FANTASTIC LINEUP AND AGENDA
TODAY.
I GET TO OPEN THESE MEETINGS BY
SHARING WITH YOU THE INCREDIBLE
EFFORTS THAT TEAM ORWH AND OUR
COLLEAGUES ACROSS NIH HAVE
ENDEAVORED TO PUT FORWARD TO
ADVANCE THE HEALTH OF WOMEN
THROUGH RESEARCH AND SCIENCE.
AND I'M GOING TO COVER VERY
BRIEFLY AN OPENING ANNOUNCEMENT.
NIH AND ORWH UPDATES, SOME
POLICY AND SCIENTIFIC UPDATES,
CAREERS AND CLOSING.
I'M GOING TO APOLOGIZE UP FRONT
FOR NOT BEING ABLE TO INCLUDE
EVERYTHING THAT HAS HAPPENED
BETWEEN THE LAST MEETING IN
APRIL AND NOW, INCREDIBLE AMOUNT
OF WORK, WE'RE FOCUSING TODAY ON
OUR THEME OF INNOVATION, SO I'VE
COLLECTED THOSE ITEMS AND YOU'LL
HEAR MORE AT THE NEXT MEETING.
OKAY.
IT'S REALLY EXCITING TO SHARE
WITH YOU THAT THE NATIONAL
LIBRARY OF MEDICINE AND ORWH
COLLABORATED TO CREATE DISCOVER
WHR, A CENTRALIZED RESOURCE FOR
WOMEN'S HEALTH RESEARCH AND
FUNDING AND INFORMATION FROM NIH
SUPPORTING OUR EFFORTS TO CLOSE
THE GAPS IN WOMEN'S HEALTH
ACROSS THE LIFECOURSE.
THE SITE LINKS DIRECTLY TO OPEN
FUNDING OPPORTUNITIES FOR THE
TOPICS LISTED.
AWARDED PROJECTS, RECRUITING AND
UPCOMING CLINICAL TRIALS, THE
LATEST LITERATURE PUBLISHED ON
THOSE TOPICS AND EVEN
PATIENT-FRIENDLY SUMMARIES OF
THOSE HEALTH TOPICS.
SO WE STARTED IN OUR FIRST PHASE
WITH MENOPAUSE, POLYCYSTIC OVARY
SISYNDROME AND SER SEVERAL AUTOE
DISEASES.
IN THE FIRST WEEK IT HAD OVER
3700 VIEWS.
NATIONAL LIBRARY OF MEDICINE AND
THANK DR. STEVE SHERRY AND OUR
COLLEAGUES AT NLM FOR THIS BIG
PUSH TO GET THIS INFORMATION
AVAILABLE IN ONE PLACE TO BE
ABLE TO ASSIST IN ADDRESSING
GAPS AND PROVIDING ACCESS TO
INFORMATION THAT IS VITAL TO
MOVING THIS FIELD FORWARD.
THE NIH DIRECTOR HAS TAKEN A
VERY ACTIVE ROLE IN ADVANCING
RESEARCH ON THE HEALTH OF WOMEN.
I AM ALSO PLEASED TO SHARE WITH
YOU THAT IN MAY, WHEN WE
LAUNCHED THE NEW STRATEGIC PLAN,
THE 2024 TO 2028 NIH-WIDE
STRATEGIC PLAN FOR RESEARCH ON
THE HEALTH OF WOMEN, DR. MONICA
BERTAGNOLLI CREATED A VIDEO
ENTITLED FORGING INTO THE
FUTURE, RESEARCH ON THE HEALTH
OF WOMEN AT NIH AND BEYOND.
AND IN THAT VIDEO, SHE TALKED
ABOUT HER VISION FOR WOMEN'S
HEALTH RESEARCH.
THAT VIDEO IS THE NUMBER ONE
VIEWED VIDEO FOR NIH ON OUR NIH
YOUTUBE CHANNEL.
SO INCREDIBLE INTEREST, AND
WE'RE SO PLEASED THAT THE NIH
DIRECTOR HAS TAKEN SUCH AN
ACTIVE ROLE IN TALKING ABOUT THE
IMPORTANCE OF THIS TOPIC.
THAT SAME WEEK, NATIONAL WOMEN'S
HEALTH WEEK, WHICH IS ALWAYS THE
WEEK AFTER MOTHER'S DAY IN MAY,
WE HAD A VARIETY OF ACTIVITIES
INCLUDING A MENOPAUSE
ROUNDTABLE.
THAT WAS THE VERY FIRST OF OUR
WOMEN'S HEALTH RESEARCH
ROUNDTABLES, AND
DR. BERTAGNOLLI, AGAIN, PROVIDED
REMARKS ANNOUNCING THE LAUNCH OF
A PATHWAYS TO PREVENTION PROGRAM
FOCUSED ON MENOPAUSE.
WE SELECT ONE TOPIC, TWO MAXIMUM
PER YEAR, AND WE SELECTED
MENOPAUSE THIS YEAR.
AND THEN ON THE RIGHT SIDE, YOU
CAN SEE THAT SHE HAS SELECTED
WOMEN'S HEALTH RELEVANT TOPICS
FOR HER DIRECTOR'S BLOG.
I'M JUST POINTING OUT TWO OF
THEM HERE.
SHE'S HAD SEVERAL, BEGINNING
WITH DIAGNOSIS AND TREATMENT OF
MENTAL HEALTH CONDITIONS DURING
AND AFTER PREGNANCY, AND SHE
TALKED ABOUT MATERNAL MENTAL
HEALTH AS AN IMPORTANT CRISIS
THAT WE NEED TO ADDRESS.
AND THEN THE DISCOVERY OF CCN3,
A MATERNAL BRAIN HORMONE THAT
SHE HIGHLIGHTS ASCII TO
STRENGTHENING BONES THAT COULD
HELP TREAT OSTEOPOROSIS AND BONE
FRACTURES.
THIS HORMONE WAS FOUND IN
LACTATING FEMALE MICE WHEN THERE
WAS AN EXAMINATION TO UNDERSTAND
WHY, DESPITE A DROP IN ESTROGEN
POSTPARTUM AND INCREASED NEED
FOR CALCIUM, LACTATING FEMALES
DID NOT HAVE FURTHER BONE
RESORPTION.
SO IT WAS A WOMEN'S HEALTH
RELEVANT RESEARCH QUESTION FROM
THE BEGINNING, WHY DO LACTATING
FEMALES NOT HAVE FURTHER BONE
LOSS THAT LED TO THIS DISCOVERY,
AND ALSO ONE OF THE SCORE
INVESTIGATORS, NANCY LANE'S WORK
CONTRIBUTED TO THIS EFFORT.
DR. BERTAGNOLLI RECENTLY
ANNOUNCED HER CARE FOR HEALTH
INITIATIVE.
CARE STANDS FOR COMMUNITIES
ADVANCING RESEARCH EQUITY FOR
HEALTH, AND IT'S DESIGNED TO
CONDUCT RESEARCH ADDRESSING
DIVERSE ISSUES IN A VARIETY OF
SETTINGS AND COMMUNITIES
GEOGRAPHICALLY DIVERSE,
PARTICULARLY AMONG THOSE THAT
ARE UNDERREPRESENTED IN
BIOMEDICAL RESEARCH INCLUDING
RURAL LOCATIONS.
HER GOAL IS TO INTEGRATE
RESEARCH INTO THE CLINICAL CARE
ENVIRONMENT, AND THIS EFFORT
DOES THAT BY TRYING TO LINK TO
PRIMARY CARE PRACTICES, A
COMMUNITY-BASED PRIMARY CARE
PRACTICES, AND HOPEFULLY WITH
THE GOAL OF REDUCING BURDEN ON
PROVIDERS AS WELL BY USING
INNOVATIVE DATA COLLECTION
METHODS.
AND EVEN IMPROVE THE EFFICIENCY
OF CARE DELIVERY.
$30 MILLION HAVE BEEN INVESTED
FOR FY 24 AND GOING INTO FY 25,
SO WE'LL CERTAINLY BE FOLLOWING
THIS CLOSELY AND WOMEN'S HEALTH
IS DEFINITELY A PART OF HER
AGENDA HERE.
I ALWAYS LIKE TO SHARE WITH YOU
NIH LEADERSHIP UPDATES, SO YOU
ARE AWARE OF WHO IS ON BOARD AT
LEADERSHIP HERE.
THE NEWEST DIRECTOR OF THE
OFFICE OF AIDS RESEARCH AND THE
NIH ASSOCIATE DIRECTOR FOR AIDS
RESEARCH, DR. GERI DONENBERG HAS
BEEN NAMED FOR THAT POSITION AND
DR. ANNICA WAYMAN HAS BEEN NAMED
DEPUTY DIRECTOR OF NCATS,
BRINGING TO A TOTAL OF 12 WOMEN
IC DEPUTY DIRECTORS OUT OF THE
27, AND 13 WOMEN IC DIRECTORS
OUT OF THE 27.
DEFINITELY THE HIGHEST NUMBER WE
HAVE HAD.
AND I ALSO WANT TO WELCOME
DR. LUCIA HINDORFF, SENIOR
ADVISOR FOR SCIENTIFIC AND
ORGANIZATIONAL STRATEGY.
DR. HINDORFF COMES FROM THE
NATIONAL HUMAN GENOME RESEARCH
INSTITUTE WHERE SHE HAD SEVERAL
POSITIONS AS A PROGRAM DIRECTOR
AND AS A LEAD FOR THEIR TRAINING
DIVERSITY AND EQUITY EFFORTS.
SHE HAS OVER 100 PUBLICATIONS
AND WE'RE REALLY EXCITE TODAY
BRING HER ON BOARD TO HELP WITH
SOME SENIOR ACTIVITIES,
INCLUDING ASSISTING WITH
OVERSIGHT OF THE WHITE HOUSE
IMPLEMENTATION EFFORTS AT ORWH.
FOLKS HAVE BEEN VERY INTERESTED
IN THE WHITE HOUSE INITIATIVE ON
WOMEN'S HEALTH RESEARCH, AND SO
I'VE BEEN ASKED TO PROVIDE
UPDATES ON THAT AND SPEAK AT A
VARIETY OF COUNCILS.
FIRST NLM, THEN THE NATIONAL
ADVISORY COUNCIL FOR BIOMEDICAL
IMAGING AND BIOENGINEERING, THE
ACD, THE NIH DIRECTOR'S ADVISORY
COMMITTEE, AND THEN MOST
RECENTLY, THE NATIONAL ADVISORY
COUNCIL ON AGING.
IN THE AFTERNOON, NIA FOCUSED
SPECIFICALLY ON WOMEN'S HEALTH.
SO I GAVE AN UPDATE AND
HIGHLIGHTED SOME OF THE
IMPLEMENTATION STEPS WE'VE TAKEN
AS WELL AS OUR INTEREST IN MID
LIFE HEALTH AND I WAS FOLLOWED
BY DR. HOLLY INGRAHAM, SENIOR
AUTHOR FOR THE DISCOVERY OF THE
CCN3 MATERNAL BRAIN HORMONE THAT
BUILDS BONE.
THE TITLE OF HER PRESENTATION
WAS "UNLOCKING SECRETS OF FEMALE
PHYSIOLOGY TO IMPROVE HUMAN
HEALTH IN AGING."
IF YOU GET A CHANCE TO WATCH HER
REMARKS, SHE TALKS ABOUT HOW SHE
FOCUSED ON FEMALE PHYSIOLOGY
FROM THE OUTSET, DESPITE THE
FACT THAT THERE WAS NO ONE
REALLY ENCOURAGING HER TO DO
THAT, AND THAT SHE WAS ACTUALLY
CHALLENGED BY THE DYNAMIC
CHANGES IN FEMALE HORMONES
RATHER THAN DISSUADED BY THOSE
DYNAMIC CYCLICAL CHANGES.
AND AGAIN, DR. NANCY LANE IS THE
CO-AUTHOR ON THAT PIECE.
WE'VE ALSO BEEN BUSY ON A
NATIONAL AND GLOBAL LEVEL.
I WAS PARTICULARLY DELIGHTED TO
BE RECOGNIZED AND HONORED AT THE
2024 SOCIETY FOR WOMEN'S HEALTH
RESEARCH EVENT.
I REALLY APPRECIATE THAT
RECOGNITION.
IT WAS GREAT TO BE THERE AMONG
MANY OTHER AWARDEES AND
LUMINARIES.
RECENTLY AT THE FOUNDATION FOR
NIH, THEY FOCUSED ON WOMEN'S
HEALTH IN THEIR ANNUAL PATIENT
ENGAGEMENT SUMMIT.
IT WAS AN OPPORTUNITY TO TALK TO
ADVOCATES, PROFESSIONAL
ORGANIZATIONS AND OTHERS,
PRIVATE SECTOR IN THE SPACE, AND
COME TOGETHER IN A
PATIENT-CENTRIC WAY AND TALK
ABOUT THE IMPORTANCE OF HEARING
WOMEN'S VOICES AND FOR US, WHAT
STEPS WE ARE TAKING TO MOVE
FORWARD WITH AN NIH WOMEN'S
HEALTH AGENDA FOR THE FUTURE.
AT A GLOBAL LEVEL, I WAS REALLY,
AGAIN, DELIGHTED AND HONORED TO
BE INCLUDED AS A CHAMPION FOR
THE GLOBAL ALLIANCE FOR WOMEN'S
HEALTH HELD AT THE UNITED
NATIONS GENERAL ASSEMBLY
MEETING, AND TO SPEAK AT SWHR'S
ECH ALLIANCE JOINT SCIENCE
SUMMIT AS WELL.
NOW A FEW POLICY AND SCIENTIFIC
UPDATES.
AS I MENTIONED TO THIS GROUP
BEFORE, I'M HONORED TO CO-CHAIR
ALONG WITH THE DIRECTOR OF
NIA -- AND NIMR THE COMPASS
INITIATIVE, COMMUNITY PARTNERS
TO ADVANCE SCIENCE FOR SOCIETY.
THE PURPOSE OF THE EFFORT IS TO
ADVANCE HEALTH EQUITY, RESEARCH,
TO CATALYZE, DEPLOY AND EVALUATE
COMMUNITY-LED HEALTH EQUITY
STRUCTURAL INTERVENTIONS.
AND THESE ARE NEW -- THIS IS A
NEW PATHWAY FOR NIH.
THE GOAL IS TO DEVELOP
EVENTUALLY A NEW HEALTH EQUITY
RESEARCH MODEL.
SO THE COMPONENTS OF COMPASS
INCLUDE THE CHESIs OR
COMMUNITY LED HEALTH EQUITY
STRUCTURAL INTERVENTIONS.
THESE FUNDS WENT DIRECTLY TO
COMMUNITY ORGANIZATIONS TO
DESIGN THEIR STRUCTURAL
INTERVENTIONS FOR THEIR LOCAL
COMMUNITIES.
25 AWARDS WERE MADE IN 2023.
THERE'S A COMPASS COORDINATING
CENTER TO BRING THIS ALL
TOGETHER AND HELP MANAGE DATA,
THAT AWARD WAS ALSO MADE IN
2023, AND MORE RECENTLY, THE
HEALTH EQUITY RESEARCH HUBS WERE
AWARDED THIS PAST YEAR AND THE
MAP INDICATES THE LOCATIONS FOR
EACH OF THESE COMPONENTS OF
COMPASS DESIGNED TO WORK
TOGETHER.
I'M GOING TO HIGHLIGHT SOME OF
THE TOPICS BEING ADDRESSED IN
SOME OF THE COMMUNITY-LED
INTERVENTIONS.
AT UNIVERSITY OF MISSISSIPPI
MEDICAL CENTER, THEY'RE
ADDRESSING SOCIAL AND CULTURAL
CONTEXT.
AND UNIVERSITY OF MARYLAND
BALTIMORE, COMMUNITY HEALTH
ACCESS IN THE BUILT ENVIRONMENT
ARE ALSO BEING ACTRESSED AND AT
YALE, FOOD AND NUTRITION
ENVIRONMENT ARE BEING ADDRESSED.
IN ADDITION, OUR COLLEAGUES AT
NYU ARE LOOKING AT NUTRITION AND
FOOD IN SOCIAL AND CULTURAL
CONTEXTS, AND OUR COLLEAGUES AT
UNIVERSITY OF MICHIGAN ANN ARBOR
ARE LOOKING AT A MULTIPLE
DOMAINS, AS YOU CAN SEE HERE,
INCLUDING THE BUILT ENVIRONMENT
AND THEY'VE INCORPORATED
ECONOMIC DEVELOPMENT.
SO YOU CAN SEE THESE TOPICS ARE
ALL RELATED TO STRUCTURAL
INTERVENTIONS AND DESIGNED TO
LOOK AT THEIR IMPACT,
INTERVENTIONS AT THE STRUCTURAL
LEVEL, ON A VARIETY OF HEALTH
OUTCOMES.
INCLUDING THOSE THAT ARE HIGHLY
RELEVANT TO WOMEN'S HEALTH.
SO THE ANNUAL MEETING THIS YEAR
INCLUDED THE CHESIs
PRESENTING, THE COMMUNITY LED
ORGANIZATIONS.
I WAS DELIGHTED TO GET TO MEET
FOSTERING COMMUNITY CONNECTIONS
THROUGH NATIVE HAWAIIAN CULTURAL
VALUES TO STRENGTHEN YOUTH
RESILIENCE, HEALTH AND
WELL-BEING INVESTIGATORS.
PICTURED HERE WITH THEIR POSTER.
IT WAS A FANTASTIC MEETING
AVAILABLE ONLINE WHERE YOU COULD
HEAR DIRECTLY FROM THE
ORGANIZATIONS WHO WERE DESIGNING
THESE INTERVENTIONS.
THEY WERE HIGHLY CREATIVE AND
INNOVATIVE AND I CAN'T WAIT TO
SEE WHAT THEY WILL DO NEXT.
ALL OF THESE EFFORTS ARE
COMPLETELY ALIGNED WITH OUR NEW
NIH-WIDE STRATEGIC PLAN FOR
RESEARCH ON THE HEALTH OF WOMEN.
AND OUR FIVE GOALS ARE LISTED
HERE.
I'M GOING TO HIGHLIGHT JUST TWO
OF THEM.
IN ADDITION TO THE ONE AT THE
BOTTOM, ON THE WOU BOTTOM, ADVAE
COMMUNITY-ENGAGED SCIENCE AND
ENHANCE THE DISSEMINATION OF
EVIDENCE-BASED SOLUTIONS.
COMPASS IS HIGHLY ALIGNED WITH
THAT.
OUR FIRST GOAL.
WE WANT TO ADVANCE RESEARCH ON
THE BIOLOGICAL, BEHAVIORAL,
SOCIAL, STRUCTURAL AND
ENVIRONMENTAL FACTORS
INFLUENCING WOMEN'S HEALTH AND
THEY ALL ARE FUNCTIONING
TOGETHER.
WE'RE LEASELY COMMITTED TO
IMPROVING DATA SCIENCE AND
MANAGEMENT WITH INNOVATIVE
METHODS AND CUTTING-EDGE
TECHNOLOGIES.
A COUPLE OF METHODS AND
DATA-RELATED HIGHLIGHTS FOR YOU.
THIS GROUP IS VERY INTERESTED IN
HOW GENERAL EDITORS AND
PUBLISHERS PLAY A KEY GATE
KEEPING ROLE IN WOMEN'S HEALTH
RESEARCH AND ITS DISSEMINATION,
AND THE SEX AND GENDER EQUITY
AND RESEARCH OR SAGER GUIDELINES
HAS BEEN NOW ACCESSED NEARLY A
MILLION TIMES.
IT'S BEEN CITED OVER 700 TIMES
AND IS NOW WIDELY ADOPTED BY
MANY MAJOR ACADEMIC PUBLISHERS
BUT NOT ALL, AND THIS PAST YEAR,
IT WAS FORMALLY ADOPTED BY THE
WORLD HEALTH ORGANIZATION, WHICH
THEY SEE AS A MAJOR MILESTONE.
IT'S BEEN TRANSLATED TO SEVEN
LANGUAGES NOW.
IT'S NOW INCLUDED IN THE EQUATOR
WEBSITE, AND IT'S LISTED THE
REPORTING GUIDELINES.
THE JOURNAL OF THE NATIONAL
CANCER INSTITUTE HAS ALSO
ELEVATED THEIR STANDARDS AND
OUTLINED INCLUSIVE LANGUAGE
GUIDELINES.
HERE THEY'RE TALKING ABOUT
SUMMARY CHARACTERISTICS THAT
SHOULD BE REPORTED NOT JUST IN
TABLE ONE OR WHERE YOU DESCRIBE
DEMOGRAPHICS, BUT IN THE RESULTS
SECTION OF THE MANUSCRIPT.
THEY STATE, QUOTE, IN RESEARCH
ARTICLES AND BRIEF
COMMUNICATIONS, SEX OR GENDER
AND HOW SEX OR GENDER SHOULD BE
REPORTED AND DEFINED, AND HOW
SEX OR GENDER WAS ASSESSED
SHOULD BE DESCRIBED.
WHENEVER POSSIBLE, REPORT ALL
MAIN OUTCOMES BY SEX, OR GENDER
IF APPROPRIATE.
END QUOTE.
SO WE'RE SEEING PROGRESS IN THIS
SPACE AS WELL.
IT WAS MY PLEASURE TO WORK WITH
DR. SARAH TEMKIN WITH DR. KIM
TEMPLETON ONLINE, ONE OF THE
ADVISORY COMMITTEE MEMBERS,
FUNDED TO LOOK AT THE INCLUSION
OF SEX AND GENDER IN ORTHOPEDIC
SURGERY JOURNALS.
AND DR. TEMPLETON HAS BEEN
PUSHING FOR THESE ADVANCES FOR
SOME TIME, AND WE WERE DELIGHTED
TO BE PART OF SEVERAL MEETINGS
AND THRILLED TO BE PART OF A
SUPPLEMENT IN THE JOURNAL OF JOF
BONE AND JOINT SURGERY THAT SHE
SPEARHEAD.
THE PUBLICATION IS CITED HERE.
ONE OF THE KEY SENTENCES FROM
THIS PUBLICATION IS THAT
"TRANSLATING SEX AND GENDER
ADVANCES TO THE ENTIRE RESEARCH
ECOSYSTEM CAN CATALYZE RIGOROUS
BIOMEDICAL DISCOVERY THAT CAN
IMPROVE HEALTH."
AND, IN FACT, IT IMPROVES HEALTH
FOR EVERYONE.
IN ADDITION, MY PLEASURE TO WORK
WITH THE DIRECTOR OF THE OFFICE
OF AUTOIMMUNE DISEASE RESEARCH
AT ORWH, DR. VICTORIA SHANMUGAM
IN INTRODUCING TO THE PUBLIC.
WE HIGHLIGHT OUR GOAL TO RECEIVE
INPUT FROM THE COMMUNITY AT WRIT
LARGE ABOUT A VARIETY OF
OBJECTIVES.
SHE'S LEADING AN EFFORT TO
IDENTIFY RESEARCH AREAS FOR
CROSS-DISCIPLINARY COLLABORATION
HERE AT NIH, EXPLORE
OPPORTUNITIES TO ENHANCE THESE
COLLABORATIONS AND INNOVATION
THROUGH INTERDISCIPLINARY
RESEARCH APPROACHES, BRIDGING
GAPS BETWEEN THE INSTITUTES AND
CENTERS, AND OF COURSE WE WANT
TO IMPROVE OUTCOMES FOR
EVERYONE, IN PARTICULAR THOSE
HEALTH DISPARITY POPULATIONS
DESIGNATED BY NIH, AND
HISTORICALLY UNDERREPRESENTED
GROUPS.
OUR COLLEAGUES IN NURSING
RESEARCH HAVE ALSO BEEN
FANTASTIC PARTNERS IN
DISSEMINATING AND IMPLEMENTING
THE NIH SEX AS A BIOLOGICAL
VARIABLE AS A POLICY.
AS A RESULT OF A CONFERENCE --
ONE OF THE BROADER CONFERENCES
THAT IS HELD IN NURSING
RESEARCH, OUR COLLEAGUES
PUBLISHED THIS PAPER ON ENSURING
ACCOUNTABILITY FOR CONSIDERATION
OF SEX AS A BIOLOGICAL VARIABLE
IN NURSING OUTLOOK, WHICH
REACHES A BROAD NUMBER OF
NURSES.
DESPITE CON CENSUS THAT SEX AND
GENDER ARE DISTINCT CONSTRUCTS,
THEIR APPLICATION IN RESEARCH
REMAINS INCONSISTENT.
KEY RECOMMENDATIONS INCLUDE THE
DISSEMINATION OF RIGOROUS
RESEARCH AND THAT INCLUDES
ACCOUNTING FOR SABB
APPROPRIATELY AND REFERENCING
THE SEX AND GENDER AND EQUITY IN
RESEARCH GUIDELINES.
ONE SCIENCE UPDATE FROM NCI.
IF YOU HAVEN'T SIGNED UP FOR
NIH'S NEWS RELEASES, THIS IS A
GREAT WAY TO GET NEWS ON THE
FIRST DAY OF THAT NEWS BEING
AVAILABLE, BUT NCI PERFORMED A
LARGE-SCALE STUDY, OVER 900,000
WOMEN FROM ABOUT NINE COHORTS,
AND THEY UNCOVERED 56 COMMON
GENETIC VARIANTS ASSOCIATED WITH
MOSAIC LOSS OF CHROMOSOME X.
MANY OF THEM WERE CLOSE TO
AUTOIMMUNE DISEASE-RELATED
GENES, AND CANCER-RELATED GENES.
AND THIS IS IMPORTANT BECAUSE
MOSAIC LOSS OF CHROMOSOME X IS
LINKED TO ABNORMAL BLOOD CELL
PROLIFERATION AND VARIOUS HEALTH
ISSUES IN CREATING RISK FOR
CANCER.
SO THESE FINDINGS MAY LEAD TO
BEING ABLE TO DEVELOP PREDICTIVE
TOOLS THAT WILL DETERMINE WHICH
CHROMOSOME IS RETAINED WITH MLOX
AND EMPHASIZING THE NEED FOR
FURTHER EXPLORATION OF MLO XS
ROLE IN DISEASE RISK.
SO GREAT TO HAVE YOU WITH US,
YOU HAVE TO TELL DR. SHERRY NLM
WAS PROMINENTLY FEATURED TODAY.
I WANT TO REMIND EVERYONE ABOUT
A REQUIREMENT AND THEN ALSO
CONGRATULATE MY NLM COLLEAGUES
ON MODERNIZING THE
CLINICALTRIALS.GOV WEBSITE.
AND SO THAT'S VERY SLEEK NOW AND
EASIER TO USE THAN BEFORE.
BECAUSE OF THE 21ST CENTURY
CURES ACT, INVESTIGATORS THAT
ARE SUPPORTED ON APPLICABLE,
MEANING FDA-REGULATED PRODUCTS
OR STUDIED PHASE THREE CLINICAL
TRIALS MUST REPORT THOSE RESULTS
DISAGGREGATED BY SEX OR GENDER,
RACE AND ETHNICITY, INTO
CLINICALTRIALS.GOV.
THAT IS A REQUIREMENT FOR
STUDIES THAT STARTED AFTER
DECEMBER 2017.
WE ARE LOOKING FORWARD TO THE
OPPORTUNITY TO BE ABLE TO SEE
FOR THE FIRST TIME DISAGGREGATED
RESULTS BY SEX IN CT.GOV,
CLINICALTRIALS.GOV, FOR THESE
APPLICABLE PHASE THREE CLINICAL
TRIALS.
AS YOU KNOW, THOSE ARE THE LARGE
CLINICAL TRIALS THAT CLINICIANS
USE TO MAKE TREATMENT DECISIONS
AND WE WANT TO BE ABLE TO USE
AND MAKE SEX AND GENDER-AWARE
TREATMENT DECISIONS TO BE ABLE
TO DELIVER INDIVIDUALIZED CARE
TO EVERYONE.
I'LL SHIFT GEARS INTO TALKING A
LITTLE BIT ABOUT THE WHITE HOUSE
INITIATIVE ON WOMEN'S HEALTH
RESEARCH.
IT HAS TRULY BEEN TRANSFORMATIVE
IN WOMEN'S HEALTH RESEARCH, AND
ITS STATED PURPOSE IS TO
FUNDAMENTALLY CHANGE THE WAY WE
APPROACH AND FUND WOMEN'S HEALTH
RESEARCH ACROSS THE FEDERAL
LANDSCAPE.
SO ON NOVEMBER 13TH LAST YEAR, I
WAS DELIGHTED TO BE IN THE OVAL
OFFICE ALONG WITH
DR. BERTAGNOLLI, SECRETARY
BECERRA AND OTHERS, WITH THE
PRESIDENT AND THE FIRST LADY TO
WITNESS THE SIGNING OF THIS
PRESIDENTIAL MEMORANDUM THAT
ESTABLISHED THIS INITIATIVE.
A MONTH LATER, WE WERE ALL AT
WORK, EVEN THOUGH THAT WAS A
VERY BUSY TIME, TO RECEIVE INPUT
FROM ALL ACROSS NIH AT BOTH
LEADERSHIP AND PROGRAM LEVELS
ABOUT THE WAYS THAT WE SHOULD
ADDRESS THE 10 AREAS.
WE WERE CHALLENGED IN THAT
PRESIDENTIAL MEMO TO DEVELOP
STEPS THAT WE WERE WILLING TO
TAKE.
ALL OF THE AGENCIES ON THE
PRESIDENTIAL MEMO WERE CHALLENGE
TODAY DO THAT IN A SPRINT AND
PROVIDE THAT INFORMATION BY
DECEMBER 28TH.
AND SO BECAUSE OF THE HARD WORK
ACROSS NIH, WE WERE ABLE TO HAVE
A ROBUST NIH RESPONSE TO THAT
PRESIDENTIAL MEMO.
AS YOU KNOW, SEVERAL MONTHS
LATER, PRESIDENT BIDEN FOLLOWED
UP WITH AN EXECUTIVE ORDER
ENTITLED ADVANCING WOMEN'S
HEALTH RESEARCH AND INNOVATION.
THAT WAS SIGNED ON MARCH 18TH AT
AN EVENT THAT WAS RECOGNIZING
WOMEN'S HEALTH AND WOMEN'S
HISTORY AS WELL.
AND SO THAT EXECUTIVE ORDER HAS
MULTIPLE COMPONENTS.
THE EO 14120 INCLUDES 11 FEDERAL
AGENCIES AND DEPARTMENTS
OUTLINED HERE.
IT'S A CROSS-CUTTING PROGRAM
DESIGNED TO ADVANCE
INTERDISCIPLINARY WOMEN'S HEALTH
RESEARCH ACROSS THESE AGENCIES
TOWARDS TRANSFORMATIVE EFFORTS.
IT'S BEEN MY PLEASURE TO WORK
ACROSS THESE AGENCIES AND TO
CO-CHAIR AN INTERAGENCY WORKING
GROUP ON RESEARCH AND DATA
STANDARDS.
THAT'S ALIGNED WITH SEVERAL OF
THE SECTIONS, SECTION 3 IS ABOUT
SYSTEM-WIDEN HANSMENTS, SECTION
4 SPEAKS TO PR PRIORITIZING FEDL
INVESTMENTS IN WOMEN'S HEALTH
RESEARCH ACROSS THE AGENCIES.
I'LL TALK A LITTLE BIT ABOUT
THESE IN MORE DETAIL.
SECTION 5 IS SPEAKING TO
GALVANIZING RESEARCH ON WOMEN'S
MID LIFE HEALTH.
A TOPIC THAT HAS NOT RECEIVED
VERY MUCH ATTENTION IN THE PAST
AND A VERY IMPORTANT TOPIC AS WE
TAKE A LIFECOURSE PERSPECTIVE
FOR WOMEN'S HEALTH.
IN THAT REGARD, WE HAVE
PERFORMED A LANDSCAPE ANALYSIS
TAKING A LOOK AT
MENOPAUSE-RELATE COMMON DATA
ELEMENTS AND WE'RE MOVING
FORWARD TOWARDS BEING ABLE TO
HARMONIZE EXISTING CDEs AND
THE IMPORTANT OPPORTUNITY TO
CREATE NEW ONES.
SECTION SIX ADDRESSES LOOKING AT
THE UNMET NEEDS TO SUPPORT
WOMEN'S HEALTH RESEARCH.
SO ASSESSING GAPS IN FEDERAL
FUNDING AND IDENTIFYING CHANGES
THAT ARE NEEDED.
ONE OF THE COMMITMENTS NIH HAS
MADE IS A CROSS-CUTTING EFFORT
TO TRANSFORM WOMEN'S HEALTH
THROUGHOUT THE LIFESPAN THROUGH
AN INTERDISCIPLINARY RESEARCH
STRATEGY, WHERE WE'RE LOOKING
ACROSS THE TRADITIONAL MANDATES
OF THE 27 INSTITUTES AND
CENTERS.
WE KNOW THAT MANY DISEASES AND
CONDITIONS OVERLAP INSTITUTE AND
CENTER MISSIONS, AND SO WE WILL
BE DIRECTING $200 MILLION IN FY
25 TO FUND NEW INTERDISCIPLINARY
WOMEN'S HEALTH RESEARCH
PROJECTS, AND THE PARTNERSHIP
FOR THIS EFFORT IS BEING LED BY
DIRECTORS OF THE INSTITUTE ON
AGING, THE NIAMS, EUNICE KENNEDY
SHRIVER NATIONAL INSTITUTE ON
CHILD HEALTH AND HUMAN
DEVELOPMENT, NICHD, NIDA,
NATIONAL INSTITUTE ON DRUG
ABUSE, NATIONAL HEART, LUNG AND
BLOOD INSTITUTE AND ORWH.
AND OUR MULTIDIMENSIONAL
FRAMEWORK PICTURED HERE THAT IS
INCLUDED IN THE NIH-WIDE
STRATEGIC PLAN FOR RESEARCH ON
THE HEALTH OF WOMEN HIGHLIGHT
JUST THE IMPORTANT OPPORTUNITIES
TO ADDRESS INTERDISCIPLINARY
RESEARCH THROUGH A VARIETY OF
STRATEGIES ACROSS THE
LIFECOURSE.
THERE ARE INCREDIBLE
OPPORTUNITIES TO MOVE FORWARD,
LEVERAGE EQUITIES, BUILD ON
INVESTMENTS THAT THE INSTITUTES
HAVE BEEN MAKING, TAKE THAT
FUNDAMENTAL DISCOVERY SCIENCE
AND TRANSLATE IT INTO ACTIONABLE
BENEFIT FOR WOMEN.
AND WE ARE SEEKING TO ENHANCE
WOMEN'S HEALTH RESEARCH THROUGH
COLLABORATION, WHETHER IT'S
ALIGNING THESE EFFORTS ACROSS
NIH OR ALIGNING THEM ACROSS THE
FEDERAL GOVERNMENT.
WE ARE WORKING ON NEW SURVEY
TOOLS, ENHANCED DATA COLLECTION
AND TRANSPARENCY, STREAMLINING
EFFORTS AND MAKING THINGS EASIER
TO FIND, AMPLIFYING PRIORITIES.
THE NIH DISCOVER WHR INITIATIVE
IS UP WITH WAY TH ONE WAY WE'RET
INFORMATION EASIER TO FIND, AND
THIS IS JUST THE FIRST PHASE OF
THAT LAUNCH.
YOU SHOULD STAY TUNED BECAUSE WE
HAVE MORE PLANNED TO BE ABLE TO
SUPPORT RESEARCHERS,
PRACTITIONERS AND THE PUBLIC AS
THEY PRIORITIZE WOMEN'S HEALTH
RESEARCH.
AND IN FY 23 FOR THE FIRST TIME,
WE REPORTED OUR FUNDING FOR
MENOPAUSE USING THE RESEARCH
CONDITION AND DISEASE
CATEGORIZATION SYSTEM, WHICH IS
NIH'S PREMIER SYSTEM FOR
REPORTING RESEARCH SPENDING.
SO WE'RE ABLE TO HAVE THAT
INFORMATION AVAILABLE
TRANSPARENTLY FOR YOU.
WE WERE DELIGHTED TO WORK WITH
CDC TO DEVELOP QUESTIONS THAT
COULD BE INCLUDED ABOUT
MENOPAUSE STATUS FOR 2025 -- THE
2025 NATIONAL HEALTH INTERVIEW
SURVEY.
AS YOU KNOW, THAT REACHES A
LARGE NUMBER OF INDIVIDUALS WITH
A REPRESENTATIVE SAMPLE, AND
WILL GIVE US IMPORTANT INSIGHTS
AND DATA THAT CAN FUEL FUTURE
STUDIES.
I'M ALSO REALLY GRATEFUL TO
EVERY SINGLE INSTITUTE AND
CENTER.
ALL 27 INSTITUTES AND CENTERS,
ALL ELIGIBLE INSTITUTES AND
CENTERS THAT DO EXTRAMURAL
FUNDING SIGNED ON TO THIS NOTICE
OF SPECIAL INTEREST IN RECORD
TIME.
THIS NOSI IS LINKED TO THE
STANDING FUNDING, THE PARENT
OPPORTUNITIES THAT ARE ON THE
STREET ALL THE TIME.
THAT COVERS RESEARCH GRANTS,
CAREER DEVELOPMENT GRANTS,
FELLOWSHIPS AND SMALL BUSINESS
GRANTS, AND THE NUMBERS ARE
LISTED HERE INCLUDING
UNSOLICITED PROJECTS, SOLICITED
RESEARCH PROJECTS, Ks, Fs
AND THE SMALL BUSINESS
INNOVATION, AND SMALL BUSINESS
TECH TRANSFER APPLICATIONS.
AND YOU'RE GOING TO HEAR FROM
THE DIRECTOR OF THE OFFICE LATER
TODAY AND YOU'RE GOING TO
UNDERSTAND AFTER THAT
PRESENTATION WHAT AN INCREDIBLE
OPPORTUNITY THIS IS.
THOSE INSTITUTES AND CENTERS,
WHEN THEY SIGNED ON TO THAT
NOSI, THEY CREATED A PARAGRAPH
WHERE THEY ITEMIZE 175 PRIORITY
TOPICS RELEVANT TO WOMEN'S
HEALTH THAT ARE ALIGNED WITH
THEIR MISSION AREAS.
SIGNALING THEIR INTEREST IN
PARTICULAR TOPICS FOR THE
PUBLIC.
AND IT'S A TOTAL OF 30
PARTICIPATING INSTITUTES AND
CENTERS AND THIS IS A TOTAL OF
41 UNIQUE PATHS TO WOMEN'S
RESEARCH FUNDING.
WE'RE ALSO TRYING TO MAKE IT
EASIER TO FIND ALL OF THIS
INFORMATION, SO YOU CAN COME TO
THE ORWH WEBSITE AND GET ACCESS
TO ALL THE FUNDING OPPORTUNITIES
THAT WE'RE PARTICIPATING IN, THE
ONES THAT WE'RE LEADING, AND ALL
THE ONES THAT THE INSTITUTES AND
CENTERS ARE LEADING FROM ONE
FRONT DOOR ON OUR WEBSITE, AND
SO THAT WILL SPEED UP YOUR BEING
ABLE TO FIND THE FUNDING
OPPORTUNITY TO WHICH YOU WANT TO
APPLY, WHICH WILL GIVE YOU MORE
TIME TO PREPARE YOUR GRANT
APPLICATION.
INNOVATION IN WOMEN'S HEALTH
RESEARCH AT NIH IS OUR THEME FOR
TODAY.
WE'VE TAKEN SEVERAL STEPS TO BE
ABLE TO ADVANCE INNOVATION.
ONE OF OUR COMMITMENTS AT NIH IS
TO INCREASE OUR FUNDING IN TWO
SMALL BUSINESS INNOVATORS BY 50%
TO SUPPORT WOMEN'S HEALTH
RESEARCH.
AND THE FY 2025 OMNI BUS
SOLICITATION FOR THE SBR -- STTR
GRANT APPLICATIONS INCLUDES
SPECIFIC ARTICULATION ABOUT
WOMEN'S HEALTH FOR THE VERY
FIRST TIME.
THE NEXT SUBMISSION DATES ARE
JANUARY 5TH AND APRIL 5TH AND
ORWH SIGNED ON TO THIS OMNIBUS
FOR THE FIRST TIME.
YOU'LL HEAR FROM THE SMALL
BUSINESS EDUCATION
ENTREPRENEURIAL DEVELOPMENT OR
SEED OFFICE DIRECTOR SHORTLY,
AND IN ADDITION, THE NATIONAL
INSTITUTE OF CHILD HEALTH AND
HUMAN DEVELOPMENT AND THE
NATIONAL INSTITUTE OF BIOMEDICAL
IMAGING AND BIOENGINEERING, AND
YOU'LL HEAR FROM THAT DIRECTOR
SOON AS WELL, THEY PARTNERED TO
ISSUE A CHALLENGE TO ACCELERATE
THE DEVELOPMENT OF INOWE INNOVE
TECHNOLOGIES TO IMPROVE THE
DIAGNOSIS OF ENDOMETRIOSIS.
AND AN IMPORTANT FEMALE-SPECIFIC
CONDITION THAT AFFECTS 10% OF
WOMEN.
WE NEED BETTER DIAGNOSTICS,
EARLIER DIAGNOSIS, AND WE NEED
BETTER THERAPEUTICS AND WE HAVE
TO LISTEN TO THE VOICES OF WOMEN
WHEN THEY SAY THAT SOMETHING IS
WRONG.
HERE ARE JUST A FEW OF THE
HIGHLIGHTS FROM THE INNOVATION
WEBINARS.
THIS EFFORT IS BEING SPEARHEADED
BY DR. ELIZABETH BARR IN OUR
OFFICE AND BLOOMER TECH IS
CREATING A WEARABLE ECG DEVICE
FOR WOMEN, THE SMART BRA.
THAT IS SUPPORTED BY NHLBI.
THEY'RE PROMOTING HEALTHY
LIFESTYLES AMONG LATINAS.
THAT IS SUPPORTED BY NCI.
AND YOU CAN SEE IN THE BOTTOM
RIGHT OF THIS SLIDE, WE HAVE HAD
ONE WEBINAR IN JUNE AND WE HAVE
TWO COMING UP, ONE IN OCTOBER,
OCTOBER 30TH, AND 1 IN JANUARY.
YOU CAN SEE THAT ALL OF THE
INSTITUTES AND CENTERS ARE
COMING ABOARD TO FEATURE THEIR
WORK AND THEIR INTERESTS AND
WE'RE DELIGHTED TO BE ABLE TO
STIMULATE AND CATALYZE THIS
WORK.
IN ADDITION, WE'VE CREATED A
NATIONAL WOMEN'S HEALTH
ROUNDTABLE SERIES PROMOTING
EDUCATION AND OUTREACH.
THIS EFFORT IS LED BY DR. KAREN
WILEY AT ORWH AND WE'RE
PARTNERING WITH MANY INSTITUTES
AND CENTERS AND OFFICES LIKE THE
OFFICE OF DISEASE PREVENTION ON
THIS ROUNDTABLE SERIES.
THE VERY FIRST ROUNDTABLE WAS
THE ONE THAT I MENTIONED THAT
HAPPENED IN MAY DURING NATIONAL
WOMEN'S HEALTH WEEK, WHERE
DR. BERTAGNOLLI OPENED THE GROUP
TALKING ABOUT THE PATHWAYS TO
PREVENTION PROGRAM.
THE SECOND WAS ON ENDOMETRIOSIS
WITH NICHD AS A PARTNER ENTITLED
BEYOND THE LESION, CHARTING NEW
PATHS.
AND THE MOST RECENT ONE WAS WITH
NI MH ON MATERNAL MENTAL HEALTH
RESEARCH, ELEVATING WOMEN'S
VOICES TO IMPROVE MATERNAL
MENTAL HEALTH.
I HAVE BEEN SO PLEASED TO SEE
THE INCREDIBLE INTEREST AND
APPETITE FOR THIS TYPE OF
INFORMATION FOR JUST THESE THREE
OVER 5400 PARTICIPANTS HAVE
ATTENDED THESE SERIES, SO WE ARE
CLEARLY MEETING A NEED AND WE
CONTINUE TO WORK WITH OUR
FEDERAL PARTNERS AS WELL AS OUR
NIH PARTNERS THROUGH THAT
ROUNDTABLE.
DURING NATIONAL WOMEN'S HEALTH
WEEK, WE LAUNCHED SEVERAL KEY
RESOURCES JUST IN THAT WEEK.
I WANT TO PAUSE AND THANK ORWH
FOR THE INCREDIBLE WORK THAT
THEY DID, OUR COMMUNICATIONS
TEAM, OUR SCIENTISTS, OUR
ADMINISTRATIVE STAFF BEHIND THE
SCENES, MAKING SURE THAT WE
COULD EXECUTE AND DELIVER A
RECORD NUMBER OF RESOURCES AND
PRODUCTS AND PRESENTATIONS
DURING THAT WEEK.
I THINK THEY DESERVE THAT.
ABSOLUTELY.
THANK YOU.
[APPLAUSE]
THE STRATEGIC PLAN WAS LAUNCHED.
THE HEALTH OF WOMEN OF
U3 POPULATIONS DATA BOOK WAS
LAUNCHED.
THIS IS THE FIFTH EDITION.
IT FOLLOWS WHEN THERE'S A CENSUS
UPDATE, A U.S. CENSUS UPDATE,
AND DELINEATES HEALTH STATUS OF
WOMEN FROM DIFFERENT
BACKGROUNDS.
AND WE CREATED A TOTALLY NEW
RESOURCE, NIH FACT SHEETS ON
WOMEN'S HEALTH RESEARCH.
THESE COVER 10 TOPICS OR SO.
THEY'RE TWO PAGES EACH, VERY
QUICK READ.
THEY OUTLINE THE STATE OF
SCIENCE, THEY TALK ABOUT GAPS.
VERY EASY SOURCE TO GET
INFORMATION ON WHAT NIH IS DOING
ON THOSE SPECIFIC TOPICS.
NIH WOMEN'S HEALTH IN FOCUS,
WE'RE ALWAYS EXCITED ABOUT THAT
QUARTERLY PUBLICATION AND THE
NEWS THAT WE CAN GET OUT ABOUT
THAT.
FUTURE DIRECTIONS IN MENOPAUSE
RESEARCH, THAT WAS THE VIDEO WE
LAUNCHED, AND THEN OUR ANNUAL
NIH VIVIAN PINN SYMPOSIUM,
DR. VICTORIA SHAMAGAM WAS THE
LEAD FOR THAT.
WE PUT OUT AN INCREDIBLE AMOUNT
OF INFORMATION HIGHLIGHTING WHAT
WE KNOW ABOUT THE HEALTH OF
WOMEN, WHAT WE DON'T KNOW ABOUT
THE HEALTH OF WOMEN, AND WHERE
WE NEED TO GO TO IMPROVE THE
HEALTH OF WOMEN THROUGH PUTTING
SCIENCE AND DATA TO WORK.
THE ADVISORY COMMITTEE REPORT,
YOUR BIENNIAL REPORT, WAS ALSO
FEATURED DURING THAT WEEK.
AGAIN REMEMBER THEIR INSTITUTE
AND CENTER REPORTS, EACH
INSTITUTE HAS A TWO OR
THREE-PAGE REPORT ON THEIR
EFFORTS, AND THERE'S INTEGRATIVE
CROSS-CUTTING TOPICS ALSO
INCLUDED.
THE ORWH PROGRAMS ARE SUMMARIZED
AND THE NEXT REPORT, THE FY
23-24 REPORT, IS NOW IN
DEVELOPMENT, SO WE LOOK FORWARD
TO WORKING WITH YOU ON THIS NEXT
BIENNIAL REPORT.
IF YOU WANT TO CHECK OUT THE
LAST ONE FOR REFERENCE, YOU CAN
CHECK OUT OUR WEBSITE.
IN 2019, I HAD A CONVERSATION
WITH DR. JOHN LORE JON LORSCH, E
TALKED ABOUT AN OPPORTUNITY TO
ADVANCE WOMEN'S HEALTH RESEARCH
IN THE IDEA STATES.
THESE ARE THE 23-PLUS -- 23
STATES PLUS PUERTO RICO THAT
RECEIVE THE LEAST AMOUNT OF NIH
FUNDING.
THEY'RE ALSO SETTINGS THAT HAVE
UNDERUNDERSERVED POPULATIONS
INCLUDING WHERE MATERNAL HEALTH
OUTCOMES ARE POOR.
SO WE TOGETHER CREATED THE FIRST
FUNDING OPPORTUNITIES ON WOMEN'S
HEALTH RESEARCH.
NOW IN FY 20, WE SUPPORTED
THROUGH SUPPLEMENTS 15 STATES,
21, 11 IDEA STATES.
BY FY 23, WE HAVE PROVIDED 60
GRANTS TOTALING OVER $16 MILLION
TO THE IDEA STATES TO SUPPORT
WOMEN'S HEALTH RESEARCH TOPICS.
WE DID PRIORITIZE MATERNAL
HEALTH RESEARCH IN THOSE INITIAL
ANNOUNCEMENTS, AND THIS YEAR, FY
24, WE JUST FINISHED, WE FUNDED
FIRST CENTERS OF BIOMEDICAL
RESEARCH EXCELLENCE OR COBREs
SPECIFICALLY FOCUSED ON WOMEN'S
HEALTH.
SO WE ARE THRILLED, AND THIS MAP
HIGHLIGHTS THE IDEA STATES THAT
RECEIVED FUNDING IN ANY OF THESE
FISCAL YEARS.
YOU CAN SEE THERE ARE ONLY THREE
THAT ARE GREY THAT HAVEN'T
RECEIVED FUNDING.
THAT DOESN'T MEAN THEY'VE
ACTUALLY APPLIED.
WE WOULD LOVE TO FILL OUT THIS
MAP, AND SO TO DATE, 21 IDEA
STATES HAVE BEEN SUPPORTED
THROUGH THESE AWARDS.
AND ON THE TOP ROW HERE, YOU CAN
SEE THE PIs OF THE COBREs.
WE LED THE SUPPORT WITH GM FOR
THE UNIVERSITY OF KANSAS
LAWRENCE COBRE, WHERE HEATHER
DESAIRE IS TALKING ABOUT
LEVERAGING BIG DATA TO IMPROVE
WOMEN'S HEALTH.
NIGMS IS LEADING THE FUNDING OF
THE UNIVERSITY OF IDAHO COBRE ON
NUTRITION AND WOMEN'S HEALTH,
AND TULANE RECEIVES FUNDING FROM
GM ON SEX-BASED PREVISION PRECIN
MEDICINE.
WE WERE PARTICULARLY EXCITED TO
WELCOME THE FIRST GROUP OF IDEA
STATES INVESTIGATORS, PEOPLE
THAT WERE FUNDED THROUGH THIS
PROGRAM IN ANY YEAR FOR OUR
FIRST NIH SYMPOSIUM THIS YEAR.
EMILY HARVILLE TALKED ABOUT
PREGNANCY COMPLICATIONS IN THE
STRONG HEART STUDY AND A
PARTICULARLY DIVERSE COHORT.
THEN KEDRA WALLACE TALKED ABOUT
A NEED FOR MORE THAN TELE-TEXT
IN POSTPARTUM HYPERTENSIVE
WOMEN, A CRITICAL ISSUE FOR THE
HEALTH OF WOMEN.
YOU CAN CHECK OUT THIS SYMPOSIUM
BOOKLET AND ABSTRACTS WITH THAT
QR CODE, AN WE AND WE ARE THRIO
BE ABLE HAVE LAUNCHED THIS
EFFORT WITH MULTIPLE INSTITUTES
AND CENTERS THAT ALSO FUND THESE
RESEARCH PROGRAMS IN THE IDEA
STATES.
AS YOU KNOW, ORWH TAKES A WHOLE
PERSON HEALTH APPROACH TO
RESEARCH ON THE HEALTH OF WOMEN,
AND MENOPAUSE IS INCLUDED IN
THAT APPROACH.
WE HAVE REPRODUCTIVE AGING,
CHRONOLOGICAL AGING,
ORGAN-SPECIFIC AGING THAT WE NOW
UNDERSTAND, AND THOSE ARE ALL
HAPPENING AT THE SAME TIME IN
MID LIFE WOMEN.
SO IF YOU ARE SEEING A
48-YEAR-OLD WOMAN WHO IS
DEVELOPING BRAIN FOG OR SOME
SORT OF COGNITIVE CHANGE, YOU
DON'T KNOW IF IT'S NEW ONSET
MULTIPLE SCLEROSIS OR IF IT'S
RELATED TO MENOPAUSE, AND YOU
DON'T HAVE THAT MANY TESTS AND
DIAGNOSTIC STRATEGIES TO
DELINEATE THOSE.
OF COURSE YOU HAVE THE MS
WORKUP.
MUSCLE ATROPHY, YOU MAY HAVE A
PATIENT THAT PRESENTS WITH
BALANCE INSTABILITY.
IS THAT A NEUROLOGIC CONDITIONS,
IS IT NEURODEGENERATIVE, IS IT A
MUSCLE CONDITION, IS IT
MENOPAUSE?
BONE LOSS.
NEW FRACTURE.
UNEXPECTED.
OSTEOPENIA, OSTEOPOROSIS, JOINT
PAIN.
IS THAT ARTHRITIS, IS THAT
AUTOIMMUNE, IS THAT
DEGENERATIVE, IS THAT RELATED TO
MENOPAUSE CHANGES?
BUT MOST IMPORTANTLY, WHAT ARE
YOU GOING TO DO ABOUT IT?
AND CARDIOVASCULAR DISEASE, OF
COURSE THE LEADING CAUSE OF
DEATH FOR WOMEN WORLDWIDE, ARE
THOSE VAGUE SYMPTOMS OF
SHORTNESS OF BREATH AND FATIGUE
RELATED TO MICROVASCULAR DISEASE
THAT'S NOT DETECTABLE ON A
CORONARY ANGIOGRAM, OR IS THIS
JUST RELATED TO CHANGES
OCCURRING DURING MENOPAUSE?
METABOLIC DYSFUNCTION, CHANGES
IN ADIPOSE ACCUMULATION,
INCREASED INSULIN RESISTANCE.
HOW CAN WE SEPARATE THE MID LIFE
AGING, CHRONOLOGICAL AGING
EFFECTS FROM THE REPRODUCTIVE
AGING EFFECTS?
AND WEIGHT GAIN RELATED TO
FLUCTUATING HORMONES OR REDUCED
ENERGY EXPENDITURE IS A KEY
ISSUE FOR MID LIFE WOMEN.
MENTAL HEALTH CONCERNS RELATED
TO ANXIETY, ARE THOSE
PALPITATIONS ANXIETY, PANIC
ATTACKS, OR ARE THEY RELATED TO
MENOPAUSE?
HOT FLASHES, THE QUINTESSENTIAL
SYMPTOM OF MENOPAUSE EXPERIENCED
BY THE VAST MAJORITY OF WOMEN
WHO GO THROUGH -- WHEN THEY GO
THROUGH MENOPAUSE, IMPACT ON
SLEEP DIST DISTURBANCE, IS THERA
SLEEP DISORDER, DO YOU NEED TO
DO A WORKUP FOR SLEEP APNEA, OR
IS THIS RELATED TO HOT FLASHES
WAKING THE PERSON UP?
EITHER WAY, DISRUPTIVE SLEEP IS
AN INCREDIBLE RISK FACTOR FOR
POOR OUTCOMES.
SO WE NEED TO BE ABLE TO
DELINEATE WHEN A WOMAN PRESENTS
WITH A SYMPTOM WHETHER IT'S
MENOPAUSE-RELATED OR NOT, AND WE
NEED BETTER TOOLS TO DO THAT.
IN ADDITION, WE NEED TO BE ABLE
TO INTEGRATE ALL OF THESE
DOMAINS AND BODY SYSTEMS IN A
WAY THAT WILL ALLOW US TO TAKE
CARE OF THE WHOLE PERSON.
AND HOPEFULLY, THIS IS WHERE
WE'RE GOING, BEING ABLE DO THAT.
USING INTERDISCIPLINARY
APPROACHES, USING INNOVATIVE
STRATEGIES, USING CUTTING EDGE
TECHNOLOGIES, USING OUR
COMPUTATIONAL APPROACHES WHERE
WE CAN BRING IN DATA FROM A
VARIETY OF SOURCES, MULTIMODAL
DATA, AND BE ABLE TO UNDER STAND
USING A LIFECOURSE PERSPECTIVE
WHAT'S HAPPENING HERE, AND
INDIVIDUALIZE CARE TAILORING TO
THAT PARTICULAR WOMAN AND THEIR
NEEDS BECAUSE WE KNOW EVERY
WOMAN EXPERIENCES MENOPAUSE
DIFFERENTLY.
BECAUSE OF THE RCDC TERM, WE'RE
NOT ABLE TO REPORT THIS FUNDING
TO YOU FROM FY 23.
NIH SPENT $56 MILLION IN THIS
RCD CCTT GRI DESIGNATING
MENOPAUSE RESEARCH WITH THE VAST
MAJORITY BEING SUPPORTED BY THE
NATIONAL INSTITUTE ON AGING,
FOLLOWED BY NIMH, MENTAL HEALTH
AND HEART, LUNG AND BLOOD
INSTITUTE, AND NIDDK, WITH 19%
COMING FROM OTHER INSTITUTES
COMBINED.
THE VAST MAJORITY OF THIS
FUNDING IS FOCUSED AROUND
DEMENTIA AND COGNITIVE CHANGES,
AND SO THAT SHOWS THAT THERE'S
AN OPPORTUNITY TO ADDITIONALLY
INCORPORATE OTHER ASPECTS OF
MENOPAUSE USING THAT WHOLE
PERSON HEALTH APPROACH THAT I
MENTIONED.
AND OF COURSE THE NATIONAL
INSTITUTE ON AGING HAS HAD THE
STUDY OF WOMEN'S HEALTH ACROSS
THE NATION THAT HAS GIVEN US
SOME INCREDIBLE INSIGHTS.
I WAS ABLE TO HIGHLIGHT SOME OF
THOSE WHEN I SPOKE AT NIA'S
COUNCIL RECENTLY.
THIS AREA IS ONE OF PARTICULAR
INTEREST TO ORWH.
I WAS DELIGHTED TO BE -- TO JOIN
THE WOMEN'S CONGRESSIONAL POLICY
INSTITUTE PICTURED HERE ON THE
RIGHT FOR A CAPITOL HILL
BRIEFING ON MENOPAUSE AND MID
LIFE HEALTH.
ALSO GENEVIEVE SPOKE AT THE
MENOPAUSE ROUNDTABLE HERE LAST
MAY.
AND YOU'LL HEAR FROM THE
NATIONAL SCIENCE FOUNDATION,
SUSAN MARGULIES LATER.
WE JOINED NCI AND NSF ON A
WORKSHOP ON USING ARTIFICIAL
INTELLIGENCE TO BETTER
UNDERSTAND MENOPAUSE.
AND TH DR. BYRNES PRESENTED AT E
MENOPAUSE SOCIETY'S 2024 ANNUAL
MEETING, AND ORWH CREATED TWO
TRAVEL AWARDS FOR JUNIOR
INVESTIGATORS TO PRESENT.
JUST A SMATTERING OF OUR
EFFORTS.
WE HAVE BEEN DELIGHTED TO, WITH
ODP, NCI, NHLBI, THE AGING
INSTITUTE, CHILD HEALTH AND
MENTAL HEALTH, BE HELPING TO
PLAN THE FIRST EVER PATHWAYS TO
PREVENTION PROGRAM ON ADVANCING
MENOPAUSAL SYMPTOM MANAGEMENT.
AND THE FIRST STEP OF THIS
RIGOROUS METHODICAL APPROACH IS
A WORKSHOP.
AND THAT IS TENTATIVELY
SCHEDULED TO TAKE PLACE LATE IN
2025.
SO STAY TUNED FOR THAT.
I ALSO WANT TO APPLAUD MY
COLLEAGUES AT THE NATIONAL
INSTITUTE OF MENTAL HEALTH,
TAMARA LEWIS JOHNSON IS THE
FIRST AUTHOR AND OUR OWN MELISSA
SIMON, VIEDZ RECOMMITTEE MEMBER
IS THE LAST AUTHOR ON THIS PAPER
SUMMARIZING KEY FINDINGS FROM
MENTAL HEALTH RESEARCH DURING
THE MENOPAUSE TRANSITION FOR
RACIALLY AND ETHNICICALLY
MINORITIZED WOMEN LIVING IN THE
UNITED STATES, A SCOPING REVIEW.
THIS INCREDIBLE REVIEW
HIGHLIGHTS DATA THAT DO SHOW
THAT RACIAL AND ETHNICALLY
MINORITIZED WOMEN
DISPROPORTIONATELY ARE AFFECTED
BY MENTAL HEALTH CONDITIONS
DURING THE TRANSITION,
SPECIFICALLY DEPRESSION.
SOME OF THE OTHER CONDITIONS,
THERE WAS INSUFFICIENT DATA
BECAUSE MANY OF THE STUDIES DID
NOT HAVE SUFFICIENT NUMBERS OF
THESE WOMEN BUT THIS IS AN
INCREDIBLE SUMMARY OF A BODY OF
WORK THAT HELPS US TO UNDERSTAND
AND IDENTIFY SOME OF THE
DIFFERENCES THAT WERE
HIGHLIGHTED IN THE SWAN STUDIES
WHERE WE SAW DIFFERENCES IN
DIFFERENT GROUPS.
AND TRYING TO UNDERSTAND WHAT
ARE THE SOCIAL STRUCTURAL AND
OTHER FACTORS BEHIND THOSE
DIFFERENCES.
AND NIMH HAS TWO FUNDING
OPPORTUNITIES ON THE STREET NOW,
AN R01 AND R21 ON MOOD AND
PSYCHOSIS SYMPTOMS DURING THE
MENOPAUSE TRANSITION WITH
UPCOMING RECEIPT AND EXPIRATION
DATES SO PLEASE APPLY SO YOU CAN
TAKE ADVANTAGE OF THIS
OPPORTUNITY.
I'M JUST GOING TO HIGHLIGHT VERY
BRIEFLY A COUPLE OF OTHER WAYS
THAT NIH HAS ADDRESSED MENOPAUSE
RECENTLY.
IN THE ORWH-LED RFAs,
UNDERSTANDING CHRONIC
CONDITIONS, WE'VE CREATED WITH
MULTIPLE INSTITUTES AND CENTERS
INCLUDING NIMH, WE'RE SUPPORTING
THIS YEAR TWO STUDIES ON
REGENERATIVE BIOMATERIAL FOR
COMBATING THE GENITOURINARY
SYNDROME OF MENOPAUSE, AND ONE
ON CHANGES IN CARDIOMETABOLIC
TISSUE GENE REGULATION AND OMICS
PROFILES IN MENOPAUSE.
NIMH IS HIGHLIGHTING THREE
STUDIES THERE: NEUROENDOCRINE
MECHANISMS UNDERLYING TRAUMA
MACHINE-RELATED HYPERAROUSAL IN
BLACK WOMEN AND THE
CHRONOBIOLOGICAL BASIS OF
DEPRESSION DURING MENOPAUSE
TRANSITION, AND ALSO HORMONAL
DRIVERS OF PERIMENOPAUSAL
INFLAMMATION AND MOOD SYMPTOMS.
THESE JUST REPRESENT A FEW OF
THE EFFORTS, BUT IT'S IMPORTANT
TO SHARE WITH YOU AND THE PUBLIC
THE WAYS THAT NIH IS ADDRESSING
THESE IMPORTANT TOPICS AS WE
MOVE FORWARD.
THAT PROGRAM AT ORWH IS LED BY
DR. SARAH TEMKIN.
WE ARE THRILLED TO BE ABLE TO
ALSO SHARE OUR SECOND YEAR
FUNDING OF OUR FIRST EVER R25, A
CURRICULUM DEVELOPMENT
MECHANISM, GALVANIZING HEALTH
EQUITY THROUGH NOVEL AND DIVERSE
EDUCATIONAL RESOURCES.
IN 2024, YOU CAN SEE OUR NEW
GRANTEES, AND WE'RE ROUNDING OUT
OUR EFFORT.
WE HAD -- NOT OUR FIRST, WE HAD
AN ANNUAL INVESTIGATORS MEETING
RECENTLY, AND THAT INCLUDED A
VARIETY OF TOPICS RANGING FROM
MENOPAUSE CARE IN WOMEN WITH
HIV, A VIRTUAL EDUCATION
PROGRAM, TO DEVELOPING A
SEVEN-MODULE ONLINE CURRICULUM
FOR NURSING STUDENTS ON
TRANSGENDER HEALTH, AND YOU CAN
SEE THE OTHER TOPICS HERE, SO
REALLY -- THESE WILL BE
AVAILABLE, THESE CURRICULA WILL
BE PUBLICLY AVAILABLE ONCE
THEY'RE COMPLETED.
YOU MAY RECALL WE RELEASED A
NOTICE OF SPECIAL INTEREST
EXPRESSING INTEREST IN
SUPPORTING RESEARCH ON IMPROVING
THE TOOLS FOR GENDER MEASUREMENT
AND ASSESSMENT.
WE KNOW THAT'S AN IMPORTANT
AREA, AND OUR PREVIOUS STRATEGIC
PLAN HAD A PARTICULAR GOAL
OBJECTIVE 2.2 ON DEVELOPING
RELIABLE MEASURES RELEVANT TO
WOMEN'S HEALTH.
IN FY 23, WE AWARDED EIGHT
AWARDS FOR RESEARCH ON
TERMINOLOGY AND METHODS AROUND
ASSESSMENT OF GENDER FOCUSING ON
THE TWO-STEP APPROACH, AND HERE
OUR FUNDERS ON THE BOTTOM, OUR
ICO PARTNERS, THESE GRANTEES
WILL BE PRESENTING AT A NOVEMBEE
ARE PARTICULARLY EXCITED TO SEE
THAT PRESENTATION AND HOPE THAT
THE RESULTS OF THOSE EFFORTS
WILL HELP INFORM RESEARCH AND
GENDER BEING ASCERTAINED AND
ASSESSED MORE REGULARLY AND MORE
RIGOROUSLY THROUGHOUT HEALTH
RESEARCH.
AS A RESULT OF LAST YEAR'S --
NO, TWO YEARS AGO, 2022 -- ALL
THESE YEARS RUN TOGETHER FOR
ME -- 2022 WORKSHOP THAT WE HAD
ON GENDER AND HEALTH WITH NICHD
AND OTHER PARTNERS, THERE WAS A
SPECIAL ISSUE WE COMMISSIONED IN
SOCIAL SCIENCE AND MEDICINE.
TO FEATURE THE PRESENTATIONS AND
THE WORK OF THOSE SPEAKERS AND
INVESTIGATORS.
INCREDIBLE AMOUNT OF -- JUST
INCREDIBLE SPEAKERS AND
KEYNOTES, AND IT'S AVAILABLE ON
OUR WEBSITE IF YOU'D LIKE TO
TAKE A LOOK.
BUT GENDER POWER AND HEALTH,
MODIFIABLE FACTORS FOR
INTERVENTION.
ELIZABETH BARR IS A CO-AUTHOR ON
THIS PIECE HIGHLIGHTING OUR
INTERESTS IN THE ENTIRE SPECIAL
ISSUE THAT TAKES TO THE NEXT
LEVEL THE WORK THAT WAS
PRESENTED IN THE WORKSHOP.
OUR E-LEARNING COURSES ATTRACT A
DIVERSE AUDIENCE OF LEARNERS,
AND WIDESPREAD PARTICIPATION
OVER THAT FIVE-YEAR TIME PERIOD,
WE'VE HAD OVER 2800 REGISTRANTS.
THE FAVORITE BENCH TO BEDSIDE
COURSE IS THE ONE ON IMMUNOLOGY.
I CONFESS THAT'S MY FAVORITE ONE
TOO, AND WE HAVE A VARIETY OF
SABV COURSES.
THAT AREA IS LED BY DR. SHARON
HUNTER AT ORWH, AND THAT -- IN
THAT MODULE, THE FAVORITE ONE IS
SABV AND THE HEALTH OF WOMEN AND
MEN.
80% OF THE LEARNERS
SELF-DESCRIBE AS FEMALE AND IN
TERMS OF LOCATIONS, THEY ARE
SCATTERED AROUND THE WORLD,
REACHING 69 COUNTRIES.
SO WE CONTINUE TO SUPPORT
INTERPROFESSIONAL EDUCATION
AROUND SEX AND GENDER TO INFORM
AND IMPROVE THE HEALTH OF WOMEN
AND PROVIDE A WIDE VARIETY OF
EDUCATIONAL TOOLS AT ALL LEVELS,
AT ALL PROFESSIONAL LEVELS
INCLUDING TRAIN THE TRAINER
MATERIALS FOR THOSE PROFESSORS
WHO NEED TO TEACH SABV AS PART
OF THEIR GRADUATE WORK.
A COUPLE OF UPDATES ON CAREERS.
I'M WRAPPING UP.
I SEE I'M A LITTLE CLOSE TO
TIME.
I'M GOING TO WRAP UP HERE
QUICKLY.
AS YOU KNOW, THE SCORE, THE
SPECIALIZED CENTERS OF RESEARCH
EXCELLENCE ON SEX DIFFERENCE, WE
ADDED A CAREER ENHANCEMENT CORE
IN OUR LAST ITERATION.
THE ANNUAL MEETING WAS HELD
RECENTLY.
DR. AGARWAL WAS OUR POINT PERSON
FOR THIS ONE, AND DR. VICTOR
DZAU AND DR. CAROLYN MAZURE
DELIVERED INCREDIBLE
PRESENTATIONS FROM THE SCORE
INVESTIGATORS, PEOPLE THAT
RECEIVED PILOT FUNDING FROM OUR
CAREER ENHANCEMENT CORE.
JUST ALWAYS AN EXCITING GROUP OF
SCIENCE AND WE WERE IN PERSON
FOR THE FIRST TIME IN FIVE
YEARS, SO WE WERE THRILLED TO BE
ABLE TO SUPPORT THAT EFFORT,
HEAR FROM OUR INVESTIGATORS AND
PEOPLE THAT WERE SUPPORTED BY
THE SCORE GRANTS.
THE NEXT DAY, WE HAD OUR BIRCWH
MEETING, THE SPEAKER RECOGNIZED
FOR THE RUTH KIRSCHSTEIN
MEMORIAL LECTURESHIP.
THIS YEAR IT WAS ABBEY BERENSON,
AND THEN DR. NINA SCHOR WITH WAS
OUR LEGACY OF LEADERSHIP
LECTURER AND TOOK A VERY
DIFFERENT TACT, INTERWOVE HER
SCIENCE THROUGH HER STORY.
AGAIN BETWEEN THESE BOOK ENDS,
BIRCWH SCHOLARS PRESENTED
AMAZING WORK THEY HAVE ADVANCED,
AND THE PIs AND THE
SCHOLARS -- THE PIs INTRODUCED
EACH SCHOLAR, SO IT WAS A REALLY
NICE WAY FOR THEM TO HEAR FROM
THEIR PI ABOUT WHAT THEY THINK
ABOUT THEM.
AND THEN IN AN EFFORT THAT IS
LED BY OUR OFFICE, WE PARTNER
WITH NIDDY TO AWARD ADVANCING
GENDER INCLUSIVE EXCELLENCE, A
COORDINATING CENTER TO VIRGINIA
COMMONWEALTH UNIVERSITY.
THIS COORDINATING CENTER IS
GOING TO DEVELOP A RESEARCH
STRATEGY TO ADVANCE GENDER
EQUITY IN ACADEMIA, AND THEY'RE
GOING TO MANAGE THAT PROGRAM,
CREATING A CENTRALIZED RESOURCE,
AND LESSONS LEARNED, BEST
PRACTICES, METRICS AND THE LIKE.
AND THEY WILL DEVELOP AND
IMPLEMENT A COMMUNICATIONS
DISSEMINATION AND ALSO
ADMINISTER AND MANAGE A PILOT
AND FEASIBILITY STUDIES PROGRAM
WHERE UNIVERSITIES AND
ORGANIZATIONS CAN PILOT
STRATEGIES RELATED TO
GENDER-BASED INEQUITIES.
IN TERMS OF UPCOMING EVENTS, I
WANT TO HIGHLIGHT RECENT
NATIONAL ACADEMIES OF SCIENCE
AND MEDICINE WORKSHOP WHERE
SHE'S CO-CHAIRING AN EFFORT OF
REGENERATIVE MEDICINE AND
WOMEN'S HEALTH.
FANTASTIC LINEUP.
I CAN'T WAIT TO WATCH THE TAPE.
IT WAS THE SAME TIME AS THE
BIRCWH MEETING SO I COULDN'T DO
BOTH.
AND THEN COMING UP ON
OCTOBER 30TH, WE'RE HAVING
ANOTHER SMALL BUSINESS WEBINAR.
OADR-ORWH IS HAVING THEIR FIFTH
SESSION ON GETTING INPUT FROM
THE PUBLIC AND GIVING UPDATES ON
NOVEMBER 8TH, AND THEN OADR-ORWH
SCIENCE TALKS IS FOCUSED ON THE
CANCER AUTOIMMUNE CONNECTION,
DECODING THE PARADOX.
I KNOW DR. SHAMAGAM WOULD LOVE
TO SEE YOU ALL THERE ON DECEMBE.
ALL OF THESE SESSIONS HAVE BEEN
VERY POPULAR IN THE SCIENTIFIC
COMMUNITY.
ATION I WRAP UP HERE, I JUST
WANT TO HIGHLIGHT OUR WOMEN'S
HEALTH IN FOCUS QUARTERLY
PUBLICATION.
IT JUST CAME OUT.
IT'S FOCUSED ON INFECTIOUS
DISEASE.
I WENT BACK ACTUALLY RECENTLY TO
LOOK AT THE TOPICS THAT WE'VE
COVERED IN THESE QUARTERLY
PUBLICATIONS.
WE HAVE COVERED A FULL RANGE OF
WOMEN'S HEALTH TOPICS.
IT'S TRULY HEAD TO TOE.
INSIDE AND OUT APPROACH.
EACH OF THESE INCLUDES A SCIENCE
SPOTLIGHT, AN INSTITUTIONAL
SPOTLIGHT, AND THIS ONE, WE IN
OUR SCIENCE SPOTLIGHT
INTERVIEWED DR. M MARAZZO.
THERE'S CONTENT ABOUT THE
INCREDIBLE AND DISTURBING
SITUATION WITH CONGENITAL
SYPHILIS AND SYPHILIS INFECTION
IN THIS COUNTRY, AS WELL AS SEX
DIFFERENCES IN INFECTION AND
IMMUNITY RELATED TO MICROBES.
SO PLEASE CHECK THIS OUT.
AND IF THERE'S A TOPIC YOU'RE
INTERESTED IN, THERE IS PROBABLY
A PREVIOUS INFO CUSS IN FOCUS D
THAT.
SO WE WORK WITH THE INSTITUTES
AND CENTERS, WE INVITE GUEST
EDITORS FOR THIS FIRST QUARTER
EARLY PUBLICATION, AND I WANT TO
CALL OUT OUR COMMS TEAM AND
DIRECTOR FOR PUBLICIZING ALL
THIS INFORMATION THROUGH OUR
MONTHLY EMAIL, OUR IN THE SPOT
ARTICLES ON OUR WEBSITE AND YOU
CAN FOLLOW US ON SOCIAL MEDIA
HERE.
SO VIVIAN, I'M ONLY 2 MINUTES
OVER, BUT THAT DOESN'T GIVE ANY
TIME FOR DISCUSSION OR
QUESTIONS.
SHALL WE JUST TAKE ONE QUESTION
IF THERE'S ANYTHING BURNING, AND
THEN IF YOU HAVE OTHER
QUESTIONS, BECAUSE I DO WANT TO
STAY ON TIME, PLEASE WRITE THEM
DOWN, BECAUSE WE HAVE SEVERAL
DISCUSSION SLOTS DURING THE DAY,
AND I'LL BE HAPPY TO ENTERTAIN
THEM THEN.
THANK YOU SO MUCH FOR YOUR
ATTENTION.
ARE THERE ANY QUESTIONS FROM
ADVISORY MEMBERS OR VISITORS
THAT YOU MIGHT HAVE AT THE
TABLE?
>> THANK YOU FOR BEING NEAR ON
TIME.
LET ME INTRODUCE YOU.
YOU SHOULD GO UP THERE.
I THINK YOU WANT TO GO UP THERE.
>> I THINK SO.
>> IT'S NOW MY PLEASURE TO
INTRODUCE DR. BRUCE TROMBERG.
DR. TROMBERG IS THE DIRECTOR OF
THE NATIONAL INSTITUTE OF
BIOMEDICAL IMAGING AND BUY
OWNBIOENGINEERING.
SOMETIMES PEOPLE SAY NIBI BI.,
B.I'M JUST GOING TO SAY THE FULL
NAME.
HE'LL TELL US.
WHERE HE OVERSEES THE RANGE OF
PROGRAMS THAT ADDRESS
DEVELOPING, TRANSLATING AND
COMMERCIALIZING ENGINEERING
PHYSICAL SCIENCES AND
COMPUTATIONAL TECHNOLOGIES AND
BIOLOGY IN MEDICINE.
HE LEADS NIBIB'S RAPID
ACCELERATION OF DIAGNOSTICS
TECHNOLOGY OR RADX
TECHNICIANTIVE WHICH WAS
ESTABLISHED IN 2020 TO INCREASE
SARS-COV-2 TESTING CAPACITY AND
PERFORMANCE, AND BROADEN IN 2023
TO INCLUDE OVER THE COUNTER
POINT OF CARE DIAGNOSTICS FOR
ADDITIONAL DISEASES AND
CONDITIONS.
AND BRUCE PLAYED A KEY ROLE IN
NIH BEING ABLE TO RESPOND TO THE
PANDEMIC AND FOR THAT, I'M
PERSONALLY GRATEFUL.
HIS LABORATORY, THE SECTION ON
BIOMEDICAL OPTICS, IS IN THE
EUNICE KENNEDY SHRIVER NATIONAL
INSTITUTE OF CHILD HEALTH AND
HUMAN DEVELOPMENT, AND HE WORKS
ON DEVELOPING PORTABLE BEDSIDE
NON-CONTACT AND WEARABLE
TECHNOLOGIES FOR QUANTITATIVE
SENSING AND IMAGING OF TISSUE
COMPOSITION AND METABOLISM.
BRUCE CAME TO US FROM THE
UNIVERSITY OF CALIFORNIA IRVINE,
HAS HAD AN OVER 300 -- NOT
300-YEAR.
30-YEAR ACADEMIC CAREER.
>> IT FEELS LIKE 300.
>> -- DEPARTMENT OF BIOMEDICAL
ENGINEERING, HAS CO-AUTHORED
OVER 450 PUBLICATIONS, HOLDS 25
PATENTS, AND IS A MEMBER OF THE
NATIONAL ACADEMIES OF MEDICINE
AND ENGINEERING.
IT IS MY DISTINCT PLEASURE TO
WELCOME DR. BRUCE TROMBERG TO
THE 61ST MEETING OF THE ADVISORY
COMMITTEE FOR RESEARCH ON
WOMEN'S HEALTH.
DR. TROMBERG.
>> THANK YOU, JANINE.
THANK YOU.
IT'S REALLY -- IT'S FANTASTIC TO
BE HERE.
JANINE IS SUCH AN INCREDIBLE
SUPPORTER OF TECHNOLOGY.
OF COURSE THE FORMAT OF TODAY'S
MEETING IS REALLY ALL AROUND
TECHNOLOGY I THINK THIS POSSIBLY
CAME FROM JANINE'S INSPIRATIONAL
TALK IN OUR MAY COUNCIL MEETING
THIS PAST YEAR.
OF COURSE NO GOOD DEED GOES
UNPUNISHED.
SHE IS NOW OUR KEYNOTE SPEAKER
FOR BIOMEDICAL ENGINEERING.
YOU DIDN'T PUT THAT ON YOUR
EVENTS.
OCTOBER 25TH, THE BIGGEST
BIOMEDICAL ENGINEERING MEETING
IN THE WORLD.
THIS IS EXACTLY THE KIND OF
COLLABORATION BETWEEN MEDICINE,
ARTICULATION OF NEEDS AND THE
TECHNOLOGY COMMUNITY THAT WE
NEED.
SO MY TALK IS GOING TO BE A
LITTLE BIT DIFFERENT AND I HAVE
SOME KIND OF DEMOGRAPHIC DATA ON
ENGINEERS AND THE ORIGIN OF
NIBIB, AS WELL AS SOME TECHNICAL
SLIDE ON WHAT SOME OF OUR
COMMUNITY ARE DOING.
BUT I HAVE MY COLLEAGUES, YOU
KNOW, AFTER JANINE INVITED ME TO
GIVE THIS TALK, WE REALLY
REACHED OUT AND HAD A BROAD
CONVERSATION WITHIN NIBIB WITH
OUR PROGRAM TEAM AND STAFF, AND
REALLY HAD A LOT OF DISCUSSION
ON WHAT KINDS OF TECHNOLOGIES
ARE WE SUPPORTING, ARE WE DOING
ENOUGH, WHAT'S THE EXTENT AND
THE SCOPE AND THE IMPACT THAT
WE'RE HAVING.
SO THIS OPPORTUNITY IS REALLY A
CHANCE FOR EVERYONE TO GET INTO
A DIALOGUE AND DISCUSSION.
THERE'S SO MUCH ENTHUSIASM
WITHIN NIBIB AND OUR COMMUNITY,
I THINK YOU'LL BE ABLE TO SEE
THAT AND FEEL IT FROM THE TALK,
BUT THERE'S STILL LOTS OF WORK
TO DO.
SO I REALLY THANK -- I'M VERY
GRATEFUL TO MY MANY COLLEAGUES,
PROBABLY I COULD HAVE PUT ALMOST
EVERYONE IN NIBIB ON THIS SLIDE.
BUT THESE ARE KEY PROGRAM
COLLABORATORS WHO ARE MANAGING
AND DRIVING FORWARD NEW
TECHNOLOGIES RELATED TO WOMEN'S
HEALTH.
SO JUST TO GIVE YOU A LITTLE BIT
OF BACKGROUND, JANINE SORT OF
MENTIONED SOME PEOPLE CALL US
NIBIB OR NIBIB, IT'S A VERY
COMPLICATED NAME.
LET ME GO BACK TO THE ORIGINS.
WE'RE ACTUALLY VERY HAPPY IF
ANYBODY MENTIONS US AT ALL, SO
WE'RE THE ENGINEERS.
AND PEOPLE KIND OF TAKE US FOR
GRANTED.
IF STUFF WORKS, IT'S GOOD, THE
ENGINEERS BUILT IT, BUT WHEN
IT'S BRO KERNTION WE'RE IN
TROUBLE.
BROKEN, WE'RE IN TROUBLE.
SO ENGINEERING AT NIH IS KIND OF
A CONTROVERSIAL TOPIC.
HAROLD VARMUS, ONE OF THE NIH
DIRECTORS, IN FACT, THE ONE WHO
WAS AT THE HELM DURING THE
CREATION OF NIBIB, WHICH
HAPPENED IN 2000, WAS COMPLETELY
OPPOSED TO IT.
HIS PHILOSOPHY WAS THAT
BIOENGINEERING SHOULD BE IN ALL
THE INSTITUTES, AND IT DOESN'T
REALLY NEED ITS OWN INDEPENDENT
HOME.
BUT THE ENGINEERING AND THE
IMAGING COMMUNITIES REALLY GOT
TOGETHER AND PUT OVER ABOUT A
DECADE, LOTS OF PRESSURE ON
CONGRESS TO REALLY CONTEMPLATE
THAT THERE SHOULD BE A SEPARATE
INSTITUTE THAT REALLY CARES
ABOUT COMPUTATIONAL TECHNIQUES,
HARDWARE DEVELOPMENT, ALL OF THE
THINGS -- SOFT MATERIALS
ENGINEERING LIKE TISSUE
ENGINEERING, MICRO PHYSIOLOGIC
SYSTEMS.
ALL THESE THINGS THAT WERE HOPED
FOR, BUT NO SINGLE INSTITUTE
REALLY HAD, I GUESS, THE
RESPONSIBILITY FOR ADVANCING
THESE TECHNOLOGIES IN THE
CONTEXT OF ALL OF THE MOLECULAR
BIOLOGY IN MEDICINE THAT GOES ON
AT THE NIH.
SO I HAVE AN EXCERPT FROM THE
PUBLIC LAW, WHICH IS A LITTLE
BIT -- IT'S OUR CREATION STORY
AND I ALWAYS LIKE TO SHARE THIS.
THE LANGUAGE IS QUITE
INSPIRATIONAL AND
FORWARD-LOOKING.
KIND OF SURPRISING FOR CONGRESS,
BUT IT'S REALLY BEAUTIFULLY
ARTICULATED.
AND SINCE NIBIB WAS ESTABLISHED,
THIS NIBIB ESTABLISHMENT ACT,
THERE'S BEEN ENORMOUS GROWTH IN
BIOMEDICAL ENGINEERING ACROSS
THE COUNTRY AND IN FACT ALL
ACROSS THE WORLD.
YOU CAN SEE THE ARROW POINTING
TO THE INFLECTION POINT.
THERE IS A FOUNDATION CALLED THE
WHITTAKER FOUNDATION THAT SPENT
$760 MILLION OVER A 20-YEAR
PERIOD ON ESTABLISHING
BIOLOGICAL ENGINEERING
DEPARTMENTS ALL AROUND THE
COUNTRY.
SO AT THE TIME NIBIB WAS
ESTABLISHED, THERE WERE ABOUT 40
OR 50 WHAT WE CALL
ABET-CERTIFIED DEPARTMENTS IN
THE COUNTRY.
WE NOW HAVE OVER 180.
THERE ARE MORE THAN 200 GRADUATE
PROGRAMS, AND IT'S REALLY
CHANGED THE CULTURE AND THE
LANDSCAPE IN EDUCATION.
SO HUMAN HEALTH HAS BECOME A TOP
PRIORITY IN ENGINEERING.
SO I WAS AFFILIATED WITH THE
SCHOOL OF ENGINEERING IN THE
90s.
NOBODY REALLY THOUGHT ABOUT
HUMAN HEALTH BACK THEN.
IT WASN'T UNTIL THE LATE '90S,
WHEN WE GOT A GRANT FROM THE
WHITTAKER FOUNDATION, THAT
ALLOWED US TO START A A BIOMEDIL
ENGINEERING PROGRAM.
IT BECAME A NUMBER ONE OR TWO
STRATEGIC PRIORITY OF SCHOOLS OF
ENGINEERING.
WE ALSO SEE MEDICINE ENGINEERING
PARTNERSHIPS THROUGH SCHOOLS OF
MEDICINE.
SO THERE ARE TWO SCHOOLS OF
MEDICINE NOW, UNIVERSITY OF
ILLINOIS UR BAP NA CHAMPAGNE AND
TEXAS A & M UNIVERSITY.
THE TEXAS ONE FOUNDED BY MY
PREDECESSOR AND FOUNDER OF
NIBIB, ROB PE PETT IT GREW, THE
FIRST DIRECTOR.
STUDENTS WHO COME OUT ACTUALLY
GRADUATE AT LEAST IN TEXAS A
APPED M WITH A MASTER'S DEGREE
IN ENGINEERING AS WELL AS THEIR
M.D. DEGREES.
THERE ARE ALSO A NUMBER OF
CENTERS AND PERHAPS MANY OF YOU
ARE AFFILIATED WITH SOME OF
THOSE CENTERS FOR ENGINEERING
AND MEDICINE ALL AROUND THE
COUNTRY.
VIRTUALLY EVERY MAJOR RESEARCH
UNIVERSITY HAS THESE.
THEY'RE QUITE INTERDISCIPLINARY.
AND ALL OF THIS ACTIVITY HAS
HELPED DRIVE INNOVATION,
ENTREPRENEURSHIP, AND THERE'S
BEEN A REMARKABLE IMPACT IN
DIVERSITY, IN PARTICULAR IN THE
ENGAGEMENT AND PARTICIPATION OF
WOMEN IN SCHOOLS OF ENGINEERING
AND DEPARTMENTS ALL ACROSS
ENGINEERING.
AND I HAVE SOME STATISTICS THAT
I'LL SHOW YOU ON THAT.
SO WHAT DO WE DO AT NIBIB?
WE HAVE LESS THAN A PERCENT OF
THE TOTAL NIH BUDGET, BUT WE
FORM PARTNERSHIPS WITH VIRTUALLY
EVERY INSTITUTE, CENTER AND
OFFICE BECAUSE THERE'S THIS
DRIVE TO DEVELOP NEW
TECHNOLOGIES IN ENGINEERING THAT
CAN GO INTO MANY, MANY DIFFERENT
APPLICATION AREAS.
SO ENGINEERING AND IMAGING
TECHNOLOGIES ARE CENTRAL TO US.
BUT WE BUILD PARTNERSHIPS AND
DRIVE COLLABORATION ALL ACROSS
THE INSTITUTES, CENTERS AND
OFFICES.
SO IF WE BREAK DOWN HOW MUCH ALL
THE INSTITUTES ARE SPENDING ON
BIOENGINEERING, VIRTUALLY ALL OF
OUR RESOURCES AT NIBIB ARE SPENT
ON BIOENGINEERING.
YOU CAN SEE THE PERCENT FUNDING
THAT GOES TOWARDS BIOENGINEERING
AS A FUNCTION OF THE
APPROPRIATED BUDGET, SO YOU CAN
SEE WAY ON THE RIGHT SIDE, NCI
AND NIAID ARE THE BIG, BIG
CIRCLES.
THEY HAVE THE MOST MONEY PER
YEAR.
WE'RE A TINY CIRCLE IN THE UPPER
LEFT-HAND CORNER THAT'S
PROPORTIONAL TO OUR APPROPRIATED
BUDGET.
BUT THERE ARE SEVERAL
INSTITUTES, NATIONAL LIBRARY OF
MEDICINE, NIDCD, NIAMS, NEI,
THEY SPEND BETWEEN 20 AND 30% OF
THEIR BUDGETS IN TOTAL ON
BIOENGINEERING, WHICH IS A
PRETTY IMPRESSIVE NUMBER.
OVER A 10-YEAR PERIOD, THAT'S
ABOUT $60 BILLION, $55.6 BILLION
TOTAL THAT'S BEEN SPENT.
BUT IT'S INTERESTING TO LOOK AT
THE MOST RECENT TRENDS.
SO IN 2023, ALL THE INSTITUTES
HAVE SPENT, IN TOTAL, ABOUT 15%
OF THE BUDGET ON BIOENGINEERING
TECHNOLOGIES.
THAT'S OVER $7 BILLION.
THAT'S AN ENORMOUS INVESTMENT.
PEOPLE DON'T NORMALLY THINK OF
NIH AS A TECHNOLOGY INSTITUTE,
BUT THIS IS ON THE SCALE OF ALL
OF THE OTHER FEDERAL TECHNOLOGY
INSTITUTES THAT ARE INVESTING IN
HARD CORE TECHNOLOGIES.
WE ARE DOING THE SAME THING HERE
AT THE NIH.
THIS IS DOUBLING ROUGHLY EVERY
10 YEARS.
SO WE LIKE MODELING, YOU KNOW,
WE RECOGNIZE THAT THE NOBEL
PRIZE IN PHYSICS WAS FOR
ARTIFICIAL INTELLIGENCE TODAY.
SO IF WE USE SOME AI AND SOME
MODELING, WE WOULD PREDICT THAT
IN 30 YEARS, THE ENTIRE NIH
BUDGET WOULD BE SPENT ON
BIOENGINEERING BUT I DON'T KNOW
IF ANYONE'S GOING TO BE AROUND
TO SEE IF THAT'S CORRECT.
SO WHAT ARE WE SPENDING THE
MONEY ON?
WHAT ARE THE KEY TOPICAL AREAS?
SO THIS IS OUR ICONOGRAPHY
REPRESENTATION.
SO WE DO ENGINEERED BIOLOGICAL
SYSTEMS.
YOU CAN THINK OF THESE AS MICRO
PHYSIOLOGIC SYSTEMS, TISSUES ON
A CHIP, SYNTHETIC BIOLOGY.
YOU'VE HEARD OF ALL OF THESE
APPROACHES.
I'LL GIVE YOU A FEW EXAMPLES OF
THESE THROUGHOUT THE TALK.
WE SUPPORT -- WE ALSO CALL THAT
SOFT MATERIALS ENG FEARING.
WE SUPPORT SENSORS AND POINT OF
CARE DEVICES.
THESE INCLUDE BIOPHOTONIC,
BIOELECTRIC, BIOACOUSTIC TYPES
OF CENTERS, WEARABLE,
IMPLANTABLE DEVICES, THINGS THAT
CAN GO AT THE POINT OF CARE.
IF YOU THINK OF HOSPITALS, YOU
THINK OF BIG PHYSICS STUFF LIKE
YOU'LL GO INTO A GIANT MAGNET.
THIS IS SMALL PHYSICS THAT YOU
CAN BRING TO THE PATIENT AND
ACTUALLY PATIENTS CAN HAVE IN
THEIR HOMES.
OF COURSE WE DO SUPPORT THE BIG
PHYSICS TECHNOLOGIES LIKE
IMAGING TECHNOLOGIES.
SOME OF THEM ARE REALLY QUITE
SPECTACULAR.
ONE OF THEM I LIKE TO POINT OUT
OFTEN IS A WHOLE BODY PET
SCANNER THAT HAS HALF A MILLION
SCINTILLATORS, 50,000 DETECTORS.
IT ACTUALLY IS A DESIGN, IF
YOU'VE HEARD OF THE LARGE HEDRON
COLLIDER, MORE COMPACT, MORE
EFFICIENT AND MINIATURE AND
DESIGN TODAY DO ENTIRE BODY PET
SCAN IN SEVEN MINUTES.
AND EVERY SECOND, YOU CAN DO A
DYNAMIC CONTRAST ENHANCED
UPDATE.
SO IT'S REVOLUTIONIZING HOW
PEOPLE ARE LOOKING AT METABOLIC
AND FUNCTIONAL IMAGING.
WE ALSO DEVELOP THERAPEUTIC
SYSTEMS.
THESE INCLUDE ROBOTIC DEVICES,
ROBOTICALLY PROVIDED SURGERY,
EXOSKELETONS.
ALSO DEVICES TO DELIVER ENERGY
INTO THE BODY, LIKE FOCUSED
ULTRASOUND, BOTH LOW INTENSITY
AND HIGH INTENSITY.
HIGH INTENSITY FOCUSED
ULTRASOUND CAN BE USED TO
DELIVER ENERGY TO DO SURGERY
WITHOUT HAVING TO OPEN THE
TISSUE, OPEN THE BODY.
ONE VERY IMPORTANT EXAMPLE OF
THIS IS BRAIN SURGERY, WHICH YOU
CAN TREAT ESSENTIAL TREMOR WITH
FOCUSED ULTRASOUND TO THE BRAIN,
SUBMILLIMETER SPOTS TO
INACTIVATE.
YOU CAN ALSO DRIVE MOLECULAR OR
NANOPARTICLE PROCESSES USING
THAT ENERGY DELIVERY, AND SOME
OF THEM CAN BE DELIVERED USING
MINIMALLY INVASIVE AND
IMPLANLTABLE DEVICIMPLANTABLE DO
INSIDE THE BODY.
ALL OF THIS IS TIED TOGETHER
WITH COMPUTATION MODELING,
ARTIFICIAL INTELLIGENCE.
I TOOK OUT ALL OF MY A.I. SLIDES
BECAUSE IT'S JUST SO UBIQUITOUS.
EVERYTHING THAT OUR COMMUNITY IS
DOING, MOSTLY IN THE HARD
MATERIAL SPACE BUT ALSO WHAT WE
CALL SOFT MATERIALS, IS
COMPLEMENTED BY COMPUTATIONAL
MODELS THAT HELP US MAKE A
DIGITAL TWIN OF A DEVICE OR A
PROCESS, ALLOW US TO OPTIMIZE
ITS DESIGN, AND THEN ONCE WE DO
DEPLOY IT, IT ALLOWS US TO
REALLY EXTRACT UNIQUE
INFORMATION THAT'S NEVER BEEN
DERIVED BEFORE BY COMPARING HOW
WE GET OUR MEASUREMENTS FROM
THAT SYSTEM TO THE COMPUTATIONAL
MODEL.
NOW THAT'S REALLY FUNDAMENTAL TO
EVERYTHING WE DO, BUT IN TERMS
OF IMAGING TECHNOLOGIES, IT'S
JUST UBIQUITOUS.
THERE IS NO IMAGING TECHNOLOGY
OR THERE ARE VERY FEW THAT ARE
WORKING AND CERTAINLY ALL THE
EXAMPLES THAT I'LL SHOW YOU
TODAY, THE INVESTIGATORS ARE
USING COMPUTATIONAL APPROACHES
BASED ON A.I. AND MACHINE
LEARNING.
SO ALL OF THIS IS REALLY
CONNECTED IN A VERY SIGNIFICANT
WAY.
SO WE KIND OF ASKED THE
QUESTION, WHAT ABOUT THAT 15% OF
BIOENGINEERING THAT'S BEING DONE
ALL ACROSS THE NIH, WHAT
FRACTION OF THAT IS IN WOMEN'S
HEALTH?
AND WITH MATT HELPING OUR TEAM
LOOK AT THIS AND TRYING TO MAKE
SENSE OF ALL OF THESE DIFFERENT
TOPICS, WE LOOKED AT OVER 6500
APPLICATIONS, WARDS IN THE
INTERSECTION BETWEEN WOMEN'S
HEALTH AND BIOENGINEERING ALL
ACROSS THE NIH AND GROUPED THEM
TO NIBIB IN CATEGORIES RELEVANT
TO STUDY SECTIONS.
WHAT YOU SEE IS MAYBE NOT SO
SURPRISING BUT THE BIGGEST
REPRESENTATION IS IN IMAGING
TECHNOLOGIES.
WE ALSO HAVE VERY STRONG
REPRESENTATION FROM DEVICES AND
INSTRUMENTS, BIOENGINEERING AND
BIOMATERIALS.
SO REMEMBER THAT ICONOGRAPHY WE
SHOWED, THESE MAP OUT REALLY
WELL TO THE MAIN TOPIC AREAS OF
OUR FIELD.
BIOINFORMATICS, WHICH IS A KIND
OF EUPHEMISM FOR A.I. AND
COMPUTATION AND MACHINE LEARNING
APPROACHES.
THERAPEUTIC DEVICES AND MODELING
AND SIMULATION.
SO THIS HELPS US UNDERSTAND
WHERE THE NIH INVESTMENTS ARE
GOING.
AND THIS MATCHES UP REALLY WELL
WITH WHERE NIBIB'S INVESTMENTS
ARE.
IN FACT, PROBABLY AN
OVERWHELMING MAJORITY ARE IN
IMAGING AND IMAGING-RELATED
FIELDS.
YOU SEE THESE ARE BIG SLICES OF
THE PIE BUT ALSO A VERY
SIGNIFICANT FRACTION IN
BIOLOGICAL ENGINEERING,
BIOMEDICAL SYSTEMS.
THIS IS OVER A FIVE-YEAR PERIOD,
FY 19 THROUGH 23.
AND WHAT'S REALLY INTERESTING
HERE IS WHEN WE ASSESS THE
EXTENT OF OUR BUDGET COMMITMENT,
AND PROBABLY I DIDN'T MAKE THIS
POINT STRONGLY ENOUGH, ONE OF
THE REASONS WHY NIBIB EXISTS IS
TO DRIVE TECHNOLOGY DEVELOPMENT
WITHOUT A BIOLOGIC HYPOTHESIS.
SO IF YOU COME TO US AND YOU
STATE A REALLY DRIVING
HYPOTHESIS, WE'LL TYPICALLY SEND
YOU TO ANOTHER INSTITUTE THAT'S
REALLY TO ADVANCE TECHNOLOGY
DEVELOPMENT.
NEVERTHELESS, 8 TO 10% OF OUR
ANNUAL EXPENDITURE GOES TO
WOMEN'S HEALTH TECHNOLOGIES.
SOMETHING THAT IS CLE CLEARLY
CONNECTED.
SO IT A REALLY INTERESTING
STATISTIC THAT, JANINE, IF YOU
DIDN'T INVITE ME TO GIVE THIS
TALK WE NEVER REALLY WOULD HAVE
DUG INTO THIS.
AND WE HAVE MORE THAN OUR MARKET
SHARE IN TERMS OF WOMEN'S HEALTH
AND BIOENGINEERING ALL ACROSS
THE NIH.
SO THAT'S ABOUT 3.4% OF THE
GLOBAL NIH BIOENGINEERING IN
WOMEN'S HEALTH, WE'RE LESS THAN
1% OF THE BUDGET SO WE FEEL LIKE
THAT'S A VERY SIGNIFICANT SHARE
AND CAN BE INCREASED, AND
JANINE, IN YOUR TALK WHEN YOU GO
TO BMES, I THINK YOU'RE GOING TO
SATISFY A YOU'RE TO SEE SEE
GOGOINGTO SEE A REALLY BIG SURG.
SO WHAT IS AN UNDERLYING FORCE
NOT REALLY THAT WELL-KNOWN THAT
COULD BE CONTRIBUTING TO THIS
WOMEN'S HEALTH FOCUS THAT A LOT
OF OUR TECHNOLOGIES ARE
ATTENTIVE TO, AND IT'S THE
DEMOGRAPHICS OF OUR FIELD.
SO I REFERRED TO THE ENORMOUS
GROWTH OF BIOENGINEERING
DEPARTMENTS.
THE BIGGEST GROWTH DRIVER WITHIN
THAT EXPANSION, JUST IN TERMS OF
PEOPLE, ARE WOMEN ENGINEERS.
SO WE SEE COMPARING TWO TIME
POINTS, 2005 TO 2022, THE DATA
HERE IS THE PERCENTAGE OF
ENGINEERING DEGREES AWARDED TO
WOMEN.
IN 2005, 42% OF UNDERGRADS IN
BIOENGINEERING WERE WOMEN.
THIS IS THE HIGHEST PERCENTAGE
ACROSS ALL THE MAJOR ENGINEERING
DEPARTMENTS, CIVIL,
ENVIRONMENTAL, CHEMICAL,
MECHANICAL, ELECTRICAL AND
COMPUTER, REALLY PRETTY
SIGNIFICANT.
BUT IN 2022, THIS GREW NEARLY
FOUR FOLD IN TOTAL, BACHELOR'S,
MASTERS AND PH.D.
IN FACT, THE PH.D. POPULATION
GROWTH WAS ASTOUNDING, GOING
FROM 2005, NI 98 DOCTORAL, PH.Ds
AWARD IN THE COUNTRY.
IN 2022, THERE WERE 498.
SO THIS IS A REALLY PRETTY
IMPRESSIVE GROWTH THAT
CONSTITUTED ABOUT 44% WOMEN IN
PH.D. PROGRAMS AND GETTING
PH.D. DEGREE FS BIOMEDICAL, AND
OVER HALF OF UNDERGRADS ARE
WOMEN IN 2022, AND THIS IS MORE
OR LESS, ONCE THE COMMUNITY HIT
THAT 50% OR SO, IT'S HOVERING AT
50 AND IN SOME CASES EVEN GOING
A LITTLE BIT HIGHER.
SO I THINK THIS IS A VERY STABLE
POINT IN THE GROWTH AND
EVOLUTION OF BIOMEDICAL
ENGINEERING.
NOT ONLY HAS THERE BEEN AN
INKREAS IN THE FRACTIONAL
PERCENTAGE OF WOMEN IN ALL OF
THESE PROGRAMS, BUT IN TERMS OF
ABSOLUTE GROWTH IN TOTAL
NUMBERS, IT'S REALLY BEEN PRETTY
SPECTACULAR.
AND IF YOU COMPARE BIOMEDICAL
ENGINEERING, A FOUR-FOLD
INCREASE IN THE NUMBER OF WOMEN
THAT ARE IN THESE PROGRAMS, THIS
IS COMPARED TO OTHER
DEPARTMENTS, WHICH IS ONLY ABOUT
A 1.8 FOLD.
SO THE GROWTH RATE IS A FOK TORR
OF 2 HIGHER.
SO WITH ALL OF THOSE DEPARTMENTS
THAT ARE FORMING, THEY'RE
FORMING WITH AN INFLUX OF WOMEN
WHO ARE DRIVING AND DIVERSIFYING
SCHOOLS OF ENGINEERING, AND
THAT'S ACTUALLY INSPIRING
CHANGES IN OTHER DEPARTMENTS AS
PEOPLE SEE THE EXPANSION OF
OPPORTUNITIES IN HEALTH RELATED
AND ALTRUISTIC APPROACHES THAT
ARE EXPANDING ELECTRICAL
ENGINEERING, MECHANICAL
ENGINEERING AND THE OTHER
DEPARTMENTS AS WELL.
IN TERMS OF FACULTY, WE SEE
GOING FROM 2005 TO 2022, THERE'S
A 3.4 FOLD INCREASE IN WOMEN IN
FACULTY IN BIOENGINEERING.
ALL OF THE OTHER DEPARTMENTS ARE
A TWOFOLD 1.9X.
YOU CAN SEE BIOMEDICAL
ENGINEERING IN 2022 SNAPSHOT
HERE, 28% WOMEN.
STILL MORE TO DO TO INCREASE
THAT FRACTION, BUT STILL LEADING
AS COMPARED TO OTHER
DEPARTMENTS, AND IN TERMS OF OUR
POOL, IN TERMS OF THE SOURCE OF
STUDENTS, BOTH UNDERGRADUATES
AND PH.D. STUDENTS, THERE'S AN
OPPORTUNITY TO BE ABLE TO REALLY
ACCELERATE THAT 28%.
SO NOWHERE HAS THIS BEEN BETTER
ILLUSTRATED, THIS
TRANSFORMATION, IN STUDENTS AND
IN FACULTY THAN IN OUR DEBUT
CHALLENGE DESIGNED BY BIOMEDICAL
UNDERGRADUATE TEAMS.
THIS IS KIND OF THE SECRET
WEAPON OF OUR FIELD.
IN MANY WAYS, PROJECTS THAT
UNDERGRADUATES ARE DOING IN
EVERY SCHOOL OF ENGINEERING HAS
THESE DESIGN PROJECTS.
THOSE PROJECTS ARE QUITE SIMILAR
TO WHAT YOU MIGHT THINK OF AS A
PH.D. PROJECT FROM 10 YEARS AGO.
IT'S QUITE ASTOUNDING, WHAT
UNDERGRADUATE STUDENTS ARE GOING
TO DO -- ARE DOING, AND I'M
GOING TO SHOW YOU A VIDEO OF ONE
OF THEM IN JUST A SECOND.
BUT WE CURRENTLY HAVE A PURSE OF
$160,000, WHICH I'M PROUD TO SAY
IS INCREASING TO $190,000
THROUGH THE PARTICIPATION OF
ORWH IN THIS PROGRAM.
SO THAT'S A REALLY -- THIS IS
THE FIRST ANNOUNCEMENT OF THAT.
I THINK IT JUST MADE IT IN
PUBLIC DISCLOSURE, SO OUR TWO
NEW SPONSORS ARE ORWH AND NIA.
IN 2024, JUST TO GIVE YOU A
SENSE OF THE EXTENT OF
ENGAGEMENT, WE HAD OVER 350 --
362 STUDENTS FROM 48
UNIVERSITIES AND 24 STATES
PARTICIPATING IN THIS.
IT REALLY CAPTURES THE ENERGY
AND THE SPIRIT OF WHAT OUR
UNDERGRADUATE DESIGN TEAMS, OUR
UNDERGRADUATE PROGRAMS HAVE
PASSION FOR.
AND ONE OF THE SORT OF GREAT
REINS WHY ORWH CAN SUPPORT THIS
WITH A PRIZE IS BECAUSE WE HAVE
A LONG HISTORY OF IMPORTANT
TECHNICAL PROJECTS THAT ARE
DRIVEN BY UNDERGRADUATE STUDENTS
CONCEIVED OF AND CONTINUE TO BE
PUSHED BY THESE STUDENTS, MANY
OF THEM ARE WORKING ON
COMMERCIALIZATION WITH CONTINUED
SUPPORT FROM NIBIB AND FROM THAT
SEED OFFICE.
SO HERE AN EXAMPLE, A SNAPSHOT
OF SOME OF THE REALLY COOL
PROJECTS THAT UNDERGRADUATE
TEAMS HAVE BEEN DOING, FROM
WORKING ON A
SELF-CATHETERIZATION DEVICE,
REDESIGNING A SPECULUM, WHICH I
DIDN'T REALIZE UNTIL I SAW THIS
DEBUT AWARD THAT THE CURRENT
SPECULUM DESIGNS ARE EXACTLY THE
SAME AS 200 YEARS AGO.
SO THIS IS THE FIRST REDESIGN
FROM A MECHANICAL ENGINEERING
POINT OF VIEW OF A SPECULUM.
THIS TEAM IS WORKING ON
COMMERCIALIZATION OF THAT DEVICE
AND HAS SIGNIFICANT DI SUPPORT.
MANY PEOPLE HAVE BEEN DISCUSSING
BEING ABLE TO CAPTURE MENSTRUAL
EFFLUENT IN PADS THAT CAN BE
TAKEN FOR FURTHER ANALYSIS.
WELL, UNDERGRADUATE DESIGN TEAMS
ARE ON THIS, IN 2023, ONE OF THE
MAJOR AWARD WINNERS WAS IN THAT
AREA, AND IT'S MOVING TOWARDS A
PATH OF COMMERCIALIZATION.
SO A NUMBER OF REALLY BEAUTIFUL
INNOVATIVE AND MUCH NEEDED
TECHNOLOGIES, OUR STUDENTS ARE
GOING OUT, TALKING TO EXPERTS,
FIGURING OUT WHAT THE NEED IS,
AND COMING BACK WITH THE
CREATION OF ENTIRELY NEW
INVENTIONS AND DEVICES THAT ARE
POTENTIALLY GOING TO CHANGE THE
LANDSCAPE, BUT CERTAINLY
CHANGING THE WAY THAT THEY THINK
ABOUT WOMEN'S HEALTH
TECHNOLOGIES.
AS YOU KNOW, UNDERGRADUATES GET
THESE BEES IN THEIR BONNET, IT'S
KIND OF LIKE A BUG, IT GETS IN
THEIR HEAD, AND THEY OBSESS OVER
THAT FOR THE REST OF THEIR LIVES
AND CAREERS.
SO THIS IS CHANGING HOW PEOPLE
THINK ABOUT TECHNOLOGIES AND
WHERE THEY CAN GO.
IN 2024, WE HAD TWO IMPORTANT
PRIZE WINNERS IN WOMEN'S HEALTH,
AND IF I CAN RUN THIS VIDEO, SO
IT'S THE TOP ONE.
THAT WOULD BE GREAT.
I THINK YOU NEED TO HAVE --
GOOD.
BEAUTIFUL.
OKAY.
WHERE WAS IT?
SO THIS IS THE DESIGN TEAM
VIDEO.
>> APPROXIMATELY 140 MILLION
BABIES ARE BORN EVERY YEAR.
ABOUT 21% OF THESE BIRTHS ARE BY
CESAREAN DELIVERY.
WHEN A WOMAN IS UNDERGOING LABOR
THE BABY'S HEAD CAN GET STUCK
EXITING THE MOTHER'S PELVIS.
THIS COMPLICATION IS KNOWN AS AN
IMPACTED FETAL HEAD WHICH OCCURS
IN ABOUT 16% OF SECOND STAGE
C-SECTIONS.
THIS IS ESPECIALLY RISKY WHEN IT
OCCURS IN AN UNPLANNED EMERGENCY
C-SECTION.
THE THE PRIMARY CONCERN BECOMES
SAFELY REMOVING THE FETUS DURING
THESE PROCEDURES.
>> THE MOMENT AN INCISION IS
MADE INTO THE UTERUS THE BABY'S
OXYGEN SUPPLY IS PRO ECONOMIZED.
THIS LEAVES THE MEDICAL TEAM
WITH A MATTER OF MINUTES BEFORE
CELL DAMAGE BEGINS AND PREVENT
IRREVERSIBLE BRAIN DAMAGE.
>> RESULTING IMPACTED FETAL
HEADS REMAINS TWO CHALLENGES FOR
SURGEONS.
THE FIRST IS BEING ABLE TO GET
IN AND REACH THE BACK OF THE
BABY'S HEAD TIGHTLY IMPACTED IN
THE PELVIC BONE AND TISSUE AND
THE SECOND IS GATHERING
SUFFICIENT FORCE TO NOT HARM THE
BABY OR THE MOTHER.
>> THESE ARE EXACERBATED IN LOW
AND MIDDLE INCOME AREAS FOR TWO
REASONS.
FIRST POOR PRENATAL CARE AND
SECOND LIMITED STAFFING INTO THE
VAST MAJORITY OF SURGERIES ARE
PERFORMED BY A SINGLE NOT A PAIR
OF PHYSICIANS.
FURTHER WHILE CURRENT ASSISTIVE
DEVICES EXIST THEY'RE EXPENSIVE
AND SINGLE USE.
THIS CREATES A LOW COST REUSABLE
DEVICE THAT CAN BE USED BY A
SINGLE PHYSICIAN.
>> OVER THE PAST NINE MONTHS, WE
HAVE WORKED WITH U.S.-BASED
OB-GYN SPECIALISTS TO DEVELOP
THE CESAREAN DELIVERY GLOVE.
THE CDG HAS THREE MAIN FEATURES.
A HAND POCKET, A LEADING EDGE,
AND A SLING COMPONENT.
WE HAVE A HAND POCKET FOR THE
DOMINANT HAND FOR THE PHYSICIAN
WITH ONLY A 0.75 MILLIMETERS OF
SILICONE ON THE PALMAR SIDE
WHICH MAINTAINS THE TACTILE
SENSITIVITY DESIRED BY SURGEONS.
EXTENDING BEYOND THE FINGERTIPS,
THIS STIFFENED LEADING EDGE CAN
BE DIRECTED THROUGH THE
CONSTRICTED SPACE BETWEEN THE
IMPACTED HEAD AND UTERINE WALL.
THIS ALLOWS FOR THE DOCTOR TO
REACH BEHIND THE BABY'S HEAD.
FINALLY, THE NON-DOMINANT HAND
OF THE PHYSICIAN UTILIZES THE
SLING STRAPS TO NAVIGATE THE
HAMMOCK AND FACILITATES THE SAFE
EXTRACTION OF THE BABY.
>> HERE IS A SURGEON
DEMONSTRATING THE USE OF OUR
DEVICE IN A HIGH FIDELITY
SIMULATION.
YOU CAN SEE THE SURGEON AS SHE
INSERTS HER HAPPENED INTO THE
DEVICE AND THEN INSERTS THE
DEVICE THROUGH THE UTERINE
INCISION.
AS SHE PUSHES HER HAND DEEP IN
THE BODY, THE BODY CON TORTS TO
COVER THE BABY'S HEAD AND ALLOWS
THE DEVICE TO GET FURTHER THAN
WHERE THE HAND CAN REACH.
ONE THE DEVICE IS SUFFICIENTLY
DEEP SHE UTILIZES THE STRAPS
THAT CONFORM TO CRADLE THE FETAL
HEAD.
THIS ENSURES THE, TRACKS FORCES
ARE EVENLY DISTRIBUTED OIFER THE
SOFT FETAL HEAD.
>> APR WE OBSERVED MULTIPLE
C-SECTIONS, INTRODUCED THE
CESAREAN DELIVERY GLOVE AND
GAINED VALUABLE INSIGHTS OF THE
EXPECTED USE ENVIRONMENT AS WELL
AS HIGHLY POSITIVE FEEDBACK FROM
LIKELY USERS.
>> WE WOULD LIKE TO THANK OUR
TEAM, ADVISORS AND EVERYONE FOR
THEIR SUPPORT.
OUR PROGRESS TO DATE WOULD NOT
BE POSSIBLE WITHOUT THEM.
>> THANK YOU.
WE CAN GO BACK TO THE SLIDES.
SO IT'S ASTOUNDING, IF YOU'RE
EVER PESSIMISTIC ABOUT THE
WORLD, GO TO OUR WEBSITE AND
LOOK AT THESE VIDEOS FROM
UNDERGRADUATE STUDENTS WHO ARE
WORKING ON THESE DESIGN
PROJECTS.
NOW INCREASINGLY DESIGNED -- IN
THE OLD DAYS, IT WAS JUST A YEAR
FOR DESIGN, AND MANY
UNIVERSITIES ARE REALLY PUSHING
THAT BACK.
AND YOU CAN BEGIN TO PICK A
DESIGN PROJECT IN YOUR FRESHMAN
OR SOFT MORE YEAR.
AND STICK WITH IT THROUGH
MULTIPLE YEARS.
MANY OF THESE STUDENTS GO ON AND
TAKE FURTHER COMMERCIALIZATION
KINDS OF COURSES THAT WE AND THE
SEED PROGRAM SUPPORT SO WE'VE
HAD SEVERAL STUDENTS GO THROUGH
THAT.
AND YOU KNOW, IT'S VERY
INSPIRING, AND IT'S A POWERFUL
DRIVING FORCE BEHIND TECHNOLOGY
DEVELOPMENT IN OUR FIELD.
ANOTHER MAJOR SIGNATURE PROGRAM
THAT WE SUPPORT ARE POINT OF
CARE TECHNOLOGIES.
AND THIS ENTIRE U54 NETWORK
CALLED THE POINT OF CARE
TECHNOLOGIES RESEARCH NETWORK,
MULTIPLE UNIVERSITIES ARE
SUPPORTED THROUGH THIS FOR POINT
OF CARE TECHNOLOGIES, AND WE
ALSO HAVE SUPPORT FROM MULTIPLE
INSTITUTES AND CENTERS THAT ARE
CONTRIBUTING TO THE MISSION OF
THE NETWORK.
MOST NOTABLY, THE NETWORK IN
2020 TURNED OUT TO BE THE
FOUNDATIONAL STRUCTURE UPON
WHICH WE COULD BUILD THE RAPID
ACCELERATION OF DIKE NOS DIAGNR
TEXT RADX PROGRAM WHERE WE WERE
ABLE TO TAKE ALL THE RESEARCH
GOING ON IN THE NETWORK AND THIS
URGENT AND CRITICAL TIME AND
SHIFT IT, WE ASKED ALL THE
UNIVERSITIES, THE PRINCIPAL
INVESTIGATORS, THE EXTERNAL
ADVISORY BOARD, CAN WE SUPPORT
THE DEVELOPMENT OF COVID-19
TESTING TECHNOLOGIES, WHICH WERE
DETERMINED AND PERCEIVED TO BE
REALLY INSUFFICIENT IN APRIL OF
2020.
AND THE NETWORK PIVOTED
ENTIRELY.
WE CREATED NEW STRUCTURES, AND
WE BUILT ALL OF THIS AROUND WHAT
WE CALL AN INNOVATION FUNNEL.
A WAY TO EASILY PROPOSE IDEAS,
QUICKLY EVALUATE THEM, AND MOVE
THEM THROUGH IN MULTIPLE STAGES
TO SUPPORT SO THAT ULTIMATELY
AND OUR GOALS WITHIN THIS
PROGRAM WERE NOT JUST TO DEVELOP
A TECHNOLOGY OR DEMONSTRATE A
PROTOTYPE WORKS.
IT WAS TO GO ALL THE WAY TO
MANUFACTURING.
WE HAD WELL OVER A THOUSAND
APPLICATIONS COMING INTO OUR
INNOVATION FUNNEL.
BECAUSE OF THE NATURE OF THE
URGENCY OF THE DEVELOPMENT OF
THE TECHNOLOGIES, VERY SMALL
FRACTION ACTUALLY MADE IT
THROUGH, BUT IF YOU DID ANY HOME
TESTING, ANY POINT-OF-CARE
TESTING, VIRTUALLY -- WELL, MANY
OF THEM CAME THROUGH THE RADX
PROCESS AND RESULTED IN A VERY
SIGNIFICANT PARADIGM SHIFT IN
HOW TESTING TECHNOLOGIES WERE
DONE.
ALONG THE WAY, WE STARTED WITH
AN INNOVATION FUNNEL, BUT WE
REALIZED THAT THE PROBLEM WASN'T
NECESSARILY TECH LOGIC, IT WAS
ALSO CULTURAL.
SO WE HAD TO CREATE OTHER TYPES
OF PROGRAMS, DIGITAL HEALTH
PLATFORM, A WAY TO TEST WHETHER
OVER THE COUNTER TESTS WOULD BE
USED BY PEOPLE AT ALL.
PRIOR TO THIS, PREGNANCY TESTS
AT 8 MILLION PER YEAR WERE THE
NUMBER ONE HOME TESTING
TECHNOLOGY.
IN FEBRUARY OF 2022, WE
DISTRIBUTED A BILLION TESTS
ALONE TO PEOPLE IN THEIR HOMES.
2 1/2 BILLION IN THAT ENTIRE
YEAR IN RESPONSE TO THE OMICRON
SURGE.
WE HAD TO DEVELOP A NEW WAY TO
ADDRESS TEST PERFORMANCE WITH
VARIANTS.
WE HAD TO WORK WITH THE FDA
BECAUSE AS YOU KNOW, IF IT'S NOT
AUTHORIZED BY THE FDA, A
BEAUTIFUL TECHNOLOGY WILL NEVER
EMERGE TO SEE THE LIGHT OF DAY.
SO WE CREATED SOME VERY UNIQUE
PATHWAYS WE CALL THE INDEPENDENT
TEST ASSESSMENT PROGRAM TO
ACCELERATE THAT AUTHORIZATION,
AND WE WERE ABLE TO GET TESTS
AUTHORIZED IN AS LITTLE AS 50 TO
60 DAYS.
WE ALSO DID TEST TO TREAT
PROGRAMS AT HOME IN PARTNERSHIP
WITH OTHER HHS AGENCIES.
REDESIGNED TESTS SO THEY WERE
MORE ACCESSIBLE AND USABLE FOR
PEOPLE WITH VISUAL IMPAIRMENTS
AND DEXTERITY IMPAIRMENTS, SO WE
TESTED A BUNCH OF THINGS NOORMLY
OUT OF OUR SWIM LANE, BUT
BIOENGINEERS ARE A LITTLE NUTTY
AND WE LIKE TO EXPAND OUR
TECHNOLOGY INTO AS MANY AREAS AS
POSSIBLE.
SO THIS WAS A REALLY SIGNIFICANT
ACHIEVEMENT.
BOTTOM LINE, WE INCREASED TEST
CAPACITY THROUGH THESE
INVESTMENTS BY ABOUT 8 BILLION,
AND REALLY HELPED DRIVE AS I
MENTIONED THIS PARADIGM SHIFT
WHERE PEOPLE NOW EXPECT TESTS TO
BE DONE IN THEIR HOMES, AND LOTS
OF OPPORTUNITY FOR GROWTH WITH
THAT IN THE FUTURE.
SO THE REASON WHY I MENTIONED
SOME OF THIS DETAIL ABOUT RADX
WITH RESPECT TO COVID TESTING IS
THAT WE'VE USED THIS SAME
PLATFORM AND SAID, HEY,
INFECTIOUS DISEASE IS A
CONTINUING NEED, SO WE'RE
CONTINUING TO WORK ON THAT,
INCLUDING WORKING WITH GENIE AND
HER COLLEAGUES AT NIAID.
SYPHILIS DIAGNOSTICS THAT CAN BE
USED AT HOME AND IN THE POINT OF
CARE.
MULTI-LESION PANELS, SO WE'RE
CONTINUING TO WORK ON THAT.
SUPPORTED THE FIRST MPOX
EMERGENCY USE AUTHORIZATIONS
BOTH FOR POINT OF CARE AS WELL
AS FOR HOME SELF-SWABBING THAT
CAN THEN 50 TO A LABORATORY.
WE RECENTLY SUPPORTED THE FIRST
DE NOVO FDA-APPROVED TEST FOR
HEP-C WHICH CAN BE USED AT POINT
OF CARE WITH LESS THAN AN HOUR
TURNAROUND TIME.
BUT IN TERMS OF CHRONIC DISEASE
AND DISEASE PREVENTION, WE'VE
TAKEN ON A WHOLE BUNCH OF NEW
INITIATIVES.
FIRST IN NEUROTECHNOLOGIES, BUT
IN SEVERAL TECHNOLOGIES THAT ARE
RELATED TO WOMEN'S HEALTH.
AND WE'VE PARTNERED WITH
MULTIPLE INSTITUTES AND CENTERS,
MOST NOTABLY IN THREE CHALLENGES
THAT I'LL BRIEFLY MENTION,
PARTNERING WITH NICHD AND ORWH,
AND MULTIPLE INSTITUTES.
SO THE FIRST IS RADX TECH FOR
MATERNAL HEALTH.
SO THIS IS NOW WINDING UP AFTER
A COUPLE OF YEARS OF ONGOING
COMPETITION AND EVALUATING OF
THE TECHNOLOGY PERFORMANCE.
THIS IS $8 MILLION IN CASH
AWARDS THAT ACCELERATED
DEVELOPMENT OF MATERNAL HEALTH
DIAGNOSTIC DEVICES, WEARABLES
AND OTHER TYPES OF REMOTE
SENSING, AND THE IDEA HERE IS TO
IMPROVE -- DEVELOP TECHNOLOGIES
THAT WILL IMPROVE OUTCOMES
DURING THE FIRST YEAR OF THE
POST-PARTUM PERIOD.
SO LESS THAN A YEAR FROM THE DAY
OF BIRTH OR TO THE END OF
PREGNANCY.
SO THOSE ARE THE CONSTRAINTS ON
THESE PRIZES.
AND WE STRUCTURED AGAIN WITH
THAT RADX INNOVATION FUNNEL
CONCEPT WITH MULTIPLE STAGES
WHERE IT WAS RELATIVELY EASY FOR
YOU TO PUT IN AN APPLICATION,
AND THEN A RIGOROUS ASSESSMENT
OF VIABILITY, DEEP DIVES,
WORKING CLOSELY WITH THE TEAMS,
AWARDS AT MULTIPLE STAGES.
IN THE TECHNOLOGY ASSESSMENT
PHASE, FINALISTS WERE GIVEN OVER
A HALF A MILLION EACH, AND WE
JUST NOW COMPLETED -- I CAN'T
ANNOUNCE THE RESULTS BUT WE JUST
NOW COMPLETED THE FINAL
EVALUATION PHASE AND WE'LL BE
ANNOUNCING THE GRAND PRIZES AND
RUNNERS UP PRETTY SOON.
HOPEFULLY THESE WERE TRANSITION
TO NIH NETWORKS FOR FURTHER
CLINICAL STUDIES.
HERE ARE THE TECHNOLOGIES, THE
10 THAT MADE TO THAT FINAL
STAGE.
THESE WENT INTO OUR VALIDATION
CORE AT EMORY GEORGIA TECH WITH
MULTIPLE CLINICAL PROTOCOLS
DESIGNED TO EVALUATE THEIR
PERFORMANCE IN KIND OF A ROUND
ROBIN FASHION SO EVERY ONE OF
THEM, WE WERE ABLE TO RECRUIT A
SUFFICIENT NUMBER OF WOMEN AND
BRING THESE TECHNOLOGIES
SOMETIMES INTO THEIR HOMES, INTO
THE POINT OF CARE, AND DO
RIGOROUS EVALUATION OF THE
PERFORMANCE.
WE JUST RECENTLY EVALUATED ALL
OF THAT STUFF AND MADE
RECOMMENDATIONS TO THE IMPROVE
COMMITTEE, WHO WILL ULTIMATELY
FINALIZE WHAT SOME OF THOSE
RECOMMENDATIONS ARE.
BUT YOU CAN SEE THESE
TECHNOLOGIES REPRESENT A KIND OF
BROAD RANGE OF NEEDS.
FROM DIGITAL HEALTH PLATFORMS
THAT CAN HELP FACILITATE
ASSESSMENT OF POSTPARTUM
DEPRESSION TO A SIMPLE
DIAGNOSTIC THAT CAN BE USED AT
HOME TO ASSESS UTIs, AND
SEVERAL THAT ARE DESIGNED FOR
CARDIOVASCULAR MONITORING THAT
ARE WEARABLE DEVICES THAT CAN BE
POTENTIALLY USED AT HOME THAT
CAN EVALUATE BLOOD PRESSURE,
EVALUATE HEMORRHAGE, AND OTHER
HUMAN DYNAMIC PROPERTIES SO
EVENTUALLY PREECLAMPSIA CAN BE
OVAL WAITED AND A VARIETY OF
DIFFERENT EARLY INTERVENTIONS
CAN BE DEPLOYED ALL WITH MHEALTH
TYPES OF APPROACHES TO GIVE
RAPID AND DYNAMIC FEEDBACK
TO CLINICIANS.
ONE OF THESE WHICH MATT HAS ALSO
BEEN INVOLVED IN IS LOOKING AT
ANEMIA, USING A DIGITAL HEALTH
PLATFORM, A SMARTPHONE THAT
REALLY JUST TAKES A PICTURE OF
YOUR FINGERNAILS AND THROUGH
THAT INFORMATION CONTENT AND
ALGORITHMS THAT ARE DESIGNED TO
EXTRACT THAT INFORMATION CAN
MEASURE WHAT YOUR HEMOGLOBIN
LEVELS ARE DYNAMICALLY OVER TIME
WITHOUT ANY KIND OF BLOOD DRAW
THAT'S ASSOCIATED WITH THAT.
SO OUR NEXT CHALLENGE WAS IN
FETAL MONITORING.
WE'RE NOW SUPPORTING SIX
DIFFERENT TECHNOLOGIES IN THIS
AREA.
I WON'T GO INTO DETAILS ON THESE
BUT THEY'RE KIND OF A COLLECTION
OF BIOPHOTONIC, BIOELECTRONIC
AND BIOACOUSTIC DEVICES.
THE MINIATURIZATION OF THESE
TECHNOLOGIES INTO SIMPLE
WEARABLES WITH THE CAPABILITY TO
TRANSMIT THAT INFORMATION TO
APPS OR TO MHEALTH APPROACHES
WHERE ALGORITHMS CAN EXTRACT THE
DATA AND OPTIMIZE CONTRAST AND
INFORMATION CONTENT THAT COULD
BE FED TO PROVIDERS.
ALSO AT UCSF, A NEXT GEN
ULTRASOUND APPROACH THAT USES A
DEEP LEARNING MODEL FOR
ULTRASOUND DETECTION OF
CONGENITAL HEART DISEASE.
THIS ONE IS A LITTLE BIT
DIFFERENT IN THAT IT'S A
PROVIDER-BASED TECHNOLOGY WHERE
WOMEN WOULD HAVE TO GO AND GET
THAT ULTRASOUND, BUT IT REALLY
ADVANCES COMPUTATIONAL
APPROACHES AND EXTRACTING
INFORMATION CONTENT.
AND OUR MOST CURRENT ONE,
DEADLINE IS OCTOBER 11TH.
NICHD AGAIN IS DRIVING AND
SUPPORTING THIS.
THIS IS THE ACT ENDO CHALLENGE,
$3 MILLION IN PRIZES TO EXCEL
ACCELERATE THE DEVELOPMENT OF
NONINVASIVE TECHNOLOGIES TO
IMPROVE DIAGNOSIS OF
ENDOMETRIOSIS.
AN URGENTLY NEEDED PROBLEM.
IT'S NOT AN ENORMOUS AMOUNT OF
MONEY WE HAVE.
I BELIEVE OVER 60 APPLICANTS
THAT HAVE STARTED TO FILL OUT
THIS APPLICATION PROCESS, SO
WE'RE QUITE HOPEFUL, AND WE'VE
HAD GREAT RESPONSE FROM OUR
COMMUNITY THAT SUGGESTS THAT
WE'RE GOING TO GET LOTS OF GREAT
APPLICATIONS IN, AND THIS IS
GOING TO BE AT LEAST THE FIRST
STEP IN WHAT CAN BE SUBSEQUENT
FUNDING THAT COULD DRAMATICALLY
EXPAND AND ADVANCE THIS FIELD.
SO LET ME KIND OF RUN THROUGH,
AND THIS IS A BIT OF EYE CANDY.
I WANT TO GIVE YOU A SNAPSHOT OF
SOME OF THE TECHNOLOGIES THAT
ARE BEING DEVELOPED BY SUPPORTED
INVESTIGATORS.
I WON'T SPEND A LOT OF TIME ON
EACH ONE, BUT GIVES YOU A SENSE
FOR THE SCOPE OF ACTIVITIES AND
THE AMBITION OF OUR
INVESTIGATORS ACROSS OUR
COMMUNITY.
SO I'LL FOCUS IN FIRST ON SOME
ENGINEERED BIOLOGICAL SYSTEMS OR
WHAT WE CALL SOFT MATERIALS
ENGINEERING.
ONE INTERESTING PROBLEM THAT
ARIELLA IS WORKING ON IS THE
ENCAPSULATION OF OVARIAN TISSUE.
SO OVARIAN INSUFFICIENCY IS A
PROBLEM THAT CAN BE FACED BY
WOMEN, FOR EXAMPLE, WHO'VE GONE
THROUGH CANCER THERAPIES AT A
YOUNG AGE.
ADEALLY, ONE WOULD LIKE TO HAVE
AN OVARIAN TISSUE ALLOGRAFT AND
DO AN IMPLANTATION THAT COULD
HELP THEN ACCELERATE OR
COMPENSATE FOR THAT
INSUFFICIENCY, AND ONE OF THE
BIG CHALLENGES, OF COURSE, IS
IMMUNE REJECTION.
SO AIR YES LA HAS BEEN WORKING
ON A WAY TO TAKE THAT TISSUE AND
FORM MULTIPLE ENCANCELLATION
ZONES USING CROSSLINKING
APPROACHES TO PROTECT IT SO THAT
IT'S NOT ATTACKED BY THE IMMUNE
SYSTEM AND IT FULLY FUNCTIONAL.
SO THIS IS A DUAL GEL, AND THE
OVARIAN TISSUE, WHICH WOULD BE
AN ALLOGRAFT IS ENCAPSULATED IN
THE CORE OF THE GEL AND THEN
THERE'S A SHELL BUILT AROUND
THAT.
SO SHE'S HAD LOTS OF SUCCESS IN
BUILDING THE STRUCTURE AND
SHOWING THAT IT'S EFFECTIVE,
IT'S HORMONALLY EFFECTIVE, COULD
POTENTIALLY BE A REPLACEMENT FOR
AN ALTERNATIVE TO HORMONE
REPLACEMENT THERAPIES WHICH ARE
ONLY USING TWO PARTICULAR
AGENTS, SO THIS IS A MORE
COMPLEX AND REALISTIC TISSUE
THAT COULD BE FULLY FUNCTIONAL
AND COULD ALSO BE BANKED AND
CRYOPRESERVED THAT WOULD BE DONE
IN AN ALLOGRAFT SETTING.
THERE'S THIS REALLY SIGNIFICANT
NEED FOR CREATING SOLUTIONS FOR
URINARY INCONTINENCE, STRESS
INCONTINENCE, AND ONE OF THE
NEEDS IS TO BE ABLE TO DI
DYNAMICALLY MODULATE WHAT SLING
DESIGN SO THEY REALLY ARE BETTER
AT FUNCTIONING BOTH WHEN YOU
NEED THEM TO BE OPENED AND ALSO
WHEN THE SLING ITSELF IS SHUT,
IT NEEDS TO PREVENT LEAKAGE.
SO THIS IS A VERY CLEVER LIQUID
CRYSTAL ELASTOMER DEVICE THAT
CAN BE 3D PRINTED AND PUT ON ANY
KIND OF MATERIAL.
IT RESPONDS TO HEAT, SO IT CAN
BE ACTIVATED WITH HEAT, AND THIS
WORK IS BEING DONE BY TAYLOR
WARE, TEXAS A & M.
SO WE'RE ALL FOLLOWING CAR T
THERAPY AND EXCITED ABOUT IT FOR
HEMATOLOGIC MALIGNANCIES, BUT
THERE ARE REALLY SIGNIFICANT
LIMITATIONS IN CAR-T-CELL
THERAPY IN SOLID TUMORS LIKE IN
BREAST CANCER, AND THERE ARE
VERY SIGNIFICANT OFF-TARGET
EFFECTS AND ANTIGEN EXHAUSTION,
SO CAR-T CELLS ARE REALLY NOT
WORKING IN THESE KINDS OF
TUMORS.
SO TAL DANINO, COLUMBIA, HAS
BEEN DEVELOPING A
PROBIOTIC-GUIDED CAR-T-CELL
THERAPY FOR BREAST CANCER.
SO HIS INNOVATION IS ENGINEERING
BACTERIA, SO ENGINEERING E. COLI
TO SELECTIVELY COLONIZE TUMORS
AND RELEASE PAY LOADS WITH
ANTIGENS THAT WOULD ENHANCE
CAR-T-CELL TARGETING.
SO IT DOESN'T RELY ON THE
INTRINSIC ANTIGEN PRESENTATION
OF THE TUMOR.
IT RELIES ON AN ENGINEERED
BACTERIUM WHICH IS A SYNTHETIC
BIOLOGY APPROACH TO BE DELIVERED
AND THEN COLONIZED IN THE
MICROBIOME OF THE TUMOR THAT'S
EXPRESSED AND THEN THE
CAR-T-CELL CAN BE TRAINED OR
OTHER CAR-CELL CON JEW GGUGATESE
GONE IN TO TRAIN THE TUMOR AND
HE'S SHOWED -- IT CAPTURES STATE
OF THE ART IN SYNTHETIC
BIOENGINEERING OF BACTERIA TO
DRIVE THIS.
AND ANOTHER EXAMPLE IN SOFT
MATERIALS IS THE WORK OF LINDA
GRIFFITH, WHO'S PROFESSOR OF
BIOENGINEERING AT MIT, WHOSE
PIONEERED THE DEVELOPMENT OF A
NUMBER OF MICRO PHYSIOLOGIC
SYSTEMS, BUT SHE'S REALLY
FOCUSED HER ENERGY NOW ON AN
ORGANOID CO-CULTURE MODEL OF THE
HUMAN ENDOMETRIUM.
IT'S A FULLY SYNTHETIC
EXTRACELLULAR MATRIX, SO THE
EXTRACELLULAR MATRIX MATRIGEL
HAS BEEN OFTEN USED IN THESE
KINDS OF CO-CULTURES.
THAT'S NOT VERY REPRODUCIBLE,
IT'S HIGHLY VARIABLE.
IF YOU'RE GOING TO DRIVE
DISCOVERY, YOU HAVE TO
STANDARDIZE THESE APPROACHES IN
SOFT MATERIALS ENGINEERING JUST
LIKE WE DO IN THE DEVELOPMENT OF
OTHER TYPES OF HARDWARE.
SO THE HARDWARE THAT YOU CAN BUY
OFF THE SHELF REALLY WORKS IN A
VERY STANDARDIZED WAY.
THE ENGINEERED BIOLOGY WORKS IN
SOME PEOPL PEOPLE'S LA PEOPLE'SY
WELL.
SO LINDA HAS TAKEN ON THIS
REALLY HUGE CHALLENGE OF
ENGINEERING AND APPROACH THAT
MIMICS THE FULL ENDOMETRIAL
GROWTH AND SA CYCLE PROCESS THAT
CAN BE DISTRIBUTED TO MULTIPLE
INVESTIGATORS AND WORK EXACTLY
THE SAME, SO THAT COULD
PARALLELIZE DISCOVERY.
SO VERY BRIEFLY, THE CO-CULTURE
IS AN ENDOMETRIAL CELLS AS WELL
AS STROMAL CELLS.
YOU CAN SEE WITH 3D OBSTETRICAL
IMAGING THAT YOU CAN INTERROGATE
THESE STRUCTURES REALLY QUITE
BEAUTIFULLY, AND THEY ARE
RESPONSIVE TO PROLIFERATIVE
PHASES, MENSES, AS YOU CAN SEE
ON THE LEFT LOWER PANEL, THEY
FORM POLARIZED STRUCTURES JUST
LIKE WE SEE IN GLANDULAR
STRUCTURES IN ENDOMETRIOSIS, SO
THIS IS A BIOMIMIC THAT HAS
REALLY BEAUTIFUL FEATURES OF
ENDOMETRIAL PHYSIOLOGY, AND IT'S
A VERY STABLE PLATFORM THAT CAN
BE USED BY INVESTIGATORS TO
UNDERSTAND THIS -- TO UNDERSTAND
ENDOMETRIOSIS AND PROLIFERATION
EXTREMELY WELL.
SO I'LL GO INTO SOME BIOMEDICAL
IMAGING EXAMPLES.
THERE IS AN ENORMOUS -- IF YOU
REMEMBER THAT PIE CHART,
ENORMOUS AMOUNT OF ACTIVITY IN
BIOMEDICAL IMAGING THAT'S GOING
ACROSS OUR FIELD AND OUR
COMMUNITY.
I JUST HAVE A FEW SNAPSHOTS OF
THESE.
I THINK WE HAVE AN ENTIRE
SYMPOSIUM FOR MULTIPLE DAYS AND
ALL THE STUFF ON IMAGING.
ONE OF THE THINGS THAT REALLY
JUMPED OUT AT ME IS WORK IN
DOPPLER ULTRASOUND BREAST
IMAGING.
THIS IS BEING LED BY A GROUP AT
THE MAYO CLINIC.
WHAT THEY'RE DOING IS TAKING A
NORMAL ULTRASOUND, BUT COMBINING
NORMAL ULTRASOUND SCANNING WITH
HIGH SPEED 600 FRAMES PER
SECRETARY PO DELL-BASED DOPPLER
ULTRASOUND RECONSTRUCTION.
SO IN THE UPPER PANEL, YOU SEE
MALIGNANT BREAST TUMORS AND
BENIGN TUMORS, AND YOU SEE THE
DOPPLER SIGNATURE.
IF YOU'VE EVER DONE ULTRASOUND
OR SEEN ULTRASOUNDS WITH
DOPPLER, YOU'RE NOT NECESSARILY
TERRIBLY IMPRESSED WITH THE
STRUCTURE OF THE MICRO
VASCULATURE.
IT REALLY DOESN'T SHOW IT USING
COMMERCIAL SOFTWARE.
SO WHAT THEY'VE DONE IS TAKEN
MODEL-BASED APPROACHES FOR
RECONSTRUCTING THE INFORMATION.
THEY'VE BEEN ABLE TO PULL OUT
MICROVASCULAR STRUCTURES.
YOU CAN SEE IN THE SECOND COLUMN
AND ABLE TO USE FEATURES OF THAT
STRUCTURE LIKE THE FRACK TALL
DIMENSIONALITY TO IT, THE
BRANCHING FEATURES, AND YOU CAN
SEE ALL OF THESE NEW BIOMARKERS
IN THE THIRD ROW GOING ACROSS.
AND HAVE SHOWN IN A MORE THAN
500 PATIENT STUDY THAT THESE NEW
BIOMARKERS DRAMATICALLY ENHANCE
PERFORMANCE, SO ALMOST 94%
SENSITIVITY TO BREAST CANCER OF
ALL TUMOR SIZES AND ABOUT 89%
SPECIFICITY.
THEY'VE DEMONSTRATED THIS IN
KIDNEY, LIVER AND THYROID.
IN ADDITION TO BREAST CANCER.
SO AN INTERESTING AND PROMPTING
TECHNOLOGY DEVELOP M.
THERE ARE ALTERNATIVE APPROACHES
THAT ARE BEING DEVELOPED IN
BREAST IMAGING.
MANY OF US HAVE HEARD OF
PHOTOACOUSTIC COMPUTED
TOMOGRAPHY.
THIS INVOSMS USING A LASER WITH
A SHORT PULSE THAT DEPOSITS
ENERGY INTO THE TISSUE.
THE ENERGY IS ABSORBED BY BLOOD
VESSELS.
THE BLOOD VESSELS IN THE
DISSIPATION OF THAT ENERGY
GENERATE HEAT AND ALSO THEY
GENERATE MECHANICAL WAVES THAT
ARE PROPAGATING IN AT THE SPEED
OF SOUND FROM THE SOURCE BACK TO
THE SURFACE OF THE TISSUE.
THOSE MECHANICAL WAVES ARE WHAT
WE CALL BROADBAND ULTRASOUND, SO
YOU CAN USE AN ULTRASOUND
TRANSDUCER LITERALLY TO LISTEN
TO THE LIGHT THAT IS DEPOSITED
INSIDE THE TISSUE.
AND IF WE USE DIFFERENT
WAVELENGTHS OF LIGHT, WE CAN SEE
THE CONTRIBUTIONS DIFFERENTIALLY
OF OXYHEMOGLOBIN AND
DEOXYHEMOGLOBIN, IF YOU HAVE AN
AREA OF DENSE VASCULARITY AND
THIS IS WORK BEING LED BY MARK
AT ONE OF OUR TECHNOLOGY -- I
WOULD LIKE TO SAY THAT THESE ARE
FROM REAL PISHTS, BUT THEY
ILLUSTRATE -- I WANT TO GET
THESE THOUGH SPIN AROUND A
LITTLE BIT, THEY ILLUSTRATE THE
POTENTIAL TO SEPARATE THE
ARTERIAL SIDE FROM THE VENOUS
SIDE, AND QUANTIFY TISSUE
HEMOGLOBIN OXYGEN SATURATION IN
THE VESSELS AND IN THE TUMORS,
WHICH IS A NEW CONTRAST
MECHANISM THAT CAN BE USED TO
SEPARATE MALIGNANT FROM BENIGN
TUMORS.
IN GENITOURINARY SYMPTOMS OF
MENOPAUSE, THERE'S REALLY AN
INTERESTING PROJECT THAT IS LED
BY CHEN AND LANE AT U.C. IRVINE
WHERE THEY'VE DEVELOPED AN
INTRAVAGINAL OPTICAL COHERENCE
TOMOGRAPHY PROBE.
IF YOU HAVEN'T HEARD OF OPTICAL
COHERENCE TOMORROWGRAPHY IN THE
CONTEXT OF GENITOURINARY
SYNDROME, YOU'RE PROBABLY NOT
ALONE.
IT WAS DEVELOPED ORIGINALLY IN
OPHTHALMOLOGY, AND WE HAD LASKER
PRIZE WINNERS LAST YEAR, FEUJ
KNOWFORTHAT TECHNOLOGY.
IN OPHTHALMOLOGY, IT BEEN
TRANSFORMATIONAL IN THAT FIELD,
BUT IT BEING EXTENDED USING
FIBEROPTIC APPROACHES AND STATE
OF THE ART MICRO MECHANICAL
MACHINE SYSTEMS, SCANNERS, LOTS
OF REALLY COOL TECHNOLOGY ARE
GOING INTO THIS.
THIS GROUP HAS ADOPTED THAT
BEAUTIFUL TECHNOLOGY AND HAVE
DEVELOPED AN INTRAVAGINAL
IMAGING DEVICE THAT MEASURES THE
VAGINAL EPITHELIAL THICKNESS,
BLOOD VESSEL DENSITY, COLLAGEN
CONTENT AND ELASTICITY, AND HERE
I SHOW A SERIES OF IMAGES OF THE
VASCULAR STRUCTURE.
NOW AGAIN, THIS IS LABEL-FREE
AND THE INFORMATION ON THE
VASCULATURE COMES FROM
SCATTERING OF MOVING
ERYTHROCYTES, WHICH SHIFT THE
LIGHT SIGNAL SLIGHTLY IN
FREQUENCY, THAT'S CALLED THE
DOPPLER SHIFT.
SO THEY'RE ABLE TO TAKE THAT
INFORMATION, CALCULATE EXACTLY
WHERE THE MICRO VASCULATURE IS,
AND HERE YOU SEE BEFORE LASER
AND AFTER LASER TREATMENTS THAT
ARE SEPARATED BY FOUR WEEKS.
OOA VERY SIGNIFICANT INCREASE IN
EPITHELIAL THICKNESS.
I JUST WANT TO SHOW YOU WHAT A
TYPICAL PULL-BACK LOOKS LIKE.
SO THIS IS THE AMOUNT OF TIME
THAT IT TAKES TO GET ALL OF THAT
INFORMATION.
YOU SEE THIS IS A
CIRCUMFERENTIAL PULL-BACK VIEW.
THE DEPTH OF INTERROGATION IS
ABOUT 2 MILLIMETERS.
SO AS YOU PULL BACK, YOU GET
THAT FULL 2-MILLIMETER
THICKNESS, YOU GET THE FULL
INFORMATION CONTENT FROM THE
SURFACE AND ALL OF THAT DEPTH.
AND THEN THROUGH COMPUTATIONAL
APPROACHES CAN RENDER THAT
INFORMATION.
SO PRETTY SPECTACULAR
INFORMATION CONTENT AND
EXQUISITELY SENSITIVE CHANGES.
YOU CAN IMAGINE A VARIETY OF
DIFFERENT APPLICATIONS OF THAT.
LARINA AT THE UNIVERSITY OF
HOUSTON IS USING OCT IN MOUSE --
TO DRIVE OUR UNDERSTANDING OF
FERTILIZATION.
WHAT WE SEE HERE I DON'T
NECESSARILY NEED TO EXPLAIN IN
VIVO IMAGING OF OVULATION,
IMAGING CILIA, LOOKING AT THE
FREQUENCY OF BEADING OF THE
CILIA IN THE FALLOPIAN TUBES.
PRETTY SPECTACULAR, FIRST TIME
EVER AND THIS IS REALLY DRIVING
SOME UNDERSTANDINGS IN
TECHNOLOGY, AND IT'S BEING
TRANSLATED INTO THE CLINICAL
SETTING, WORKING WITH JENNIFER
BARTON IN THE DESIGN OF AN ENDO
SCOPE THAT CAN BE PUT THROUGH
THE CERVICAL OS AND UP INTO A
FALLOPIAN TUBE SO THE DIAMETER
IS LESS THAN A MILLIMETER.
IT PACKS IN AN ENORMOUS AMOUNT
OF CAPABILITY WITH FLUORESCENCE,
REFLECTANCE AND OPTICAL
TOMOGRAPHY.
WHAT YOU SEE, AS YOU INSERT THE
ENDOSCOPE, THE WHITE LIGHT
REFLECTING AND THEN RECONSTRUCT
INFORMATION ON THE STRUCTURE
WITHIN THE FALLOPIAN TUBE.
ON THE LOWER RIGHT, YOU CAN SEE
ONE FROM A NORMAL FLOAP WAN FALE
AND ONE WITH A PATIENT WITH
ENDOMETRIOSIS.
THEY'RE COLOR-CODED, AN ENTIRELY
NEW BIOMARKER DIAGNOSTIC THAT
REALLY HASN'T BEEN USED/SEEN
BEFORE AND THAT THEY'RE NOW
CHARACTERIZING FOR THE FIRST
TIME.
I'LL TRY TO JUST WRAP EVERYTHING
UP WITH THESE LAST TECHNOLOGY
EXAMPLES.
NIMMI RAMANUJAM AT DUKE, THE
CALLASCOPE ON RIGHT IS A
SELF-INSERTION SPECULUM-FREE
DEVICE.
YOU CAN SEE IT IN REALTIME BEING
INSERTED BY A PATIENT, AND THE
IMAGE ULTIMATELY THAT'S FORMED
IS REALLY THE SAME QUALITY AS A
VERY EXPENSIVE SCOPE THAT CAN
CAUSE 10, 15 OR 20 TIMES MORE,
DEPENDING ON WHATEVER EXAMPLE
THAT YOU GET.
AND THIS IS COMBINED WITH A
POCKET SCOPE THAT'S USED IN A
MORE TRADITIONAL SETTING WITH A
SPECULUM THAT HAS EVEN HIGHER
RESOLUTION CAPABILITY AND IS
QOIT POWERFUL QUITE POWERFUL WU
COMBINE WITH ACETYL WHITENING.
THIS IS COMBINED WITH MULTIPLE
RESEARCH SITE ALL ACROSS THE
WORLD.
SHE'S ESTABLISHED THE CALLA
HEALTH FOUNDATION IN ORDER TO
DELIVER AND EXPAND ACCESS TO
THIS TECHNOLOGIES, INEXPENSE
SIEVE TECHNOLOGY.
SHE'S COORDINATING TO DEVELOP AN
IMAGING PROBE THAT WORKS IN
COMPATIBILITY WITH THE POCKET
SCOPE ITSELF, SO CAN YOU GO TO
SPECIFIC AREAS, GET VERY HIGH
RESOLUTION OF CELLULAR
PROCESSES, AND THEN MOVE THAT
ACROSS THE CERVIX TO BUILD UP
INFORMATION CONTENT ON CERVICAL
INTEREPITHELIAL APLASIAS AND
ULTIMATELY COME TO A DIAGNOSE ON
THE SPOT.
THE PERFORMANCE OVERALL OF THIS
DEVICE ACTUALLY EXCEEDS
HISTORICAL CLINICAL PERFORMANCE.
I CAN TALK ABOUT IT BUT LET ME
JUST SHOW YOU THIS VIDEO OF THE
PROBE IN ACTION.
YOU CAN SEE THESE WHITE SPOTS,
THOSE ARE ACTUALLY CELLULAR
STRUCTURES, THE WHITE IS REFLECK
TANTS FROM ACETYL WHITENING
COMING FROM THE NUCLEUS OF THOSE
CELLS, SO EVERY ONE OF THOSE
DOTS IS FROM A SINGLE CELL FROM
THE NUCLEUS.
THE BRAITNESS AND THE DENSITY IS
THE REFLECTION OF THE DISEASE
PROCESS THAT'S OCCURRING.
ON THE REALTIME CALCULATION
USING A TYPE OF NEURAL NETWORK
APPROACH THAT SCORES THE REGION
WHERE YOU ARE, AND ACCOUNTS FOR
ALL OF THE NUMBERS OF CELLS IN
THE FIELD OF VIEW TET.
THAT'S THE MTN SCORE.
SO YOU KIND OF GET THE IDEA,
THIS IS MULTI-SCALE.
YOU GET THE MACROSCOPIC IMAGING
FROM THE POCKET COLPOSCOPE WHICH
IS EXTREMELY INEXPENSIVE AND
ACCESSIBLE, AND YOU GET THE HIGH
RESOLUTION INFORMATION FROM THIS
PROBE THAT CAN BE MOVED AROUND
AND COME UP WITH A SCORE THAT'S
HIGHLY PREDICTIVE.
THE LAST THING I'D LIKE TO
SUPPORT, WE SUPPORT A
BIOTECHNOLOGY CENTER, AND THERE
ARE ABOUT A THOUSAND VIRTUAL
PATIENT MODELS FOR FEMALES, FOR
WOMEN THAT INCLUDE DETAILED
STRUCTURES OF BREAST AND BONE TO
OPTIMIZE IMAGING TECHNOLOGIES.
THEY DEVELOP SOME PHANTOMS AND
AN APPROACH TO ASSESS THE IMPACT
OF RADIATION IN SPACE TRAVEL,
AND WERE ABLE TO PUT THESE
MODELS ON THE ARTEMUS MISSION
THAT FLU ARO FLEW AROUND THE MO.
WE THINK A LOT ABOUT DIGITAL
TWINS, SO WE CAN DO THESE WITH
THESE MODELS WITHOUT HAVING TO
GO INTO VERY EXPENSIVE
HUMAN-BASED CLINICAL TRIALS.
CLEARLY GOING INTO SPACE AND
ASSESSING HOW A FEMALE AS NOT
WOULD BE EXPOSED TO RADIATION IS
ONE THAT'S NOT REALLY EASY OR
THAT COMMON TO DO, BUT THERE'S
SOME VERY COMMON ONES LIKE DOES
DIGITAL MEMOGRAPHY WORK AS WELL
AS WHAT WE MIGHT WANT TO DO WITH
ANOTHER TECHNOLOGY?
CAN WE EVALUATE AND COMPARE
DIGITAL MAMMOGRAPHY AS COMPARED
TO NEWER EMERGING TECHNOLOGIES?
AND THESE THINGS CAN ALL BE
EVALUATED IN THESE TYPES OF
VIRTUAL STUDIES.
SO LET ME TRY TO WRAP EVERYTHING
UP.
LOTS OF INVESTMENT ACROSS THE
NIH IN BIOENGINEERING
TECHNOLOGIES.
OUR WORKFORCE HAS BEEN A KEY
DRIVER, I THINK, IN WOMEN'S
HEALTH TECHNOLOGIES IN
BIOENGINEERING.
THERE'S BEEN AN ENORMOUS
INCREASE OVER THE LAST SEVERAL
YEARS.
IN TERMS OF WOMEN'S HEALTH, WE
SEE THESE PURPOSE-DRIVEN
ENGINEERING TECHNOLOGIES COMING
TO AN INSTITUTE THAT SAYS COME
TO US WITH YOUR IDEAS WITHOUT A
PURPOSE.
SO THERE'S A VERY INTERESTING
DRIVING FORCE BEHIND THAT.
WE SEE ENORMOUS CONTRIBUTIONS
FROM THE UNDERGRADUATE DESIGN
APPROACHES.
INNOVATION, ENTREPRENEURSHIP,
THE GROWTH OF THE FEMTECH
CENTER.
I SORT OF POSE THE QUESTION, IS
ALL OF THIS EXPANSION IN OUR
COMMUNITY, UNDERGRADS AND
GRADUATE LEVEL AND FACULTY
LEVEL, IS THAT A KEY DRIVER FOR
THE GROWTH OF THESE WOMEN'S
HEALTH TECHNOLOGIES?
I IMAGINE IF YOU DOLL THE
THOUGHT EXPERIMENT AND TAKE ALL
THOSE FOLKS AWAY I THINK THE
EASY ANSWER IS YES.
BUT TO UNDERSTAND IT A LITTLE
MORE DEEPLY AND ENCOURAGE IT
FURTHER, WE HAVE A NUMBER OF
CHALLENGES.
WE NEED TO CONTINUE TO INCREASE
THE NUMBER OF WOMEN IN
BIOMEDICAL ENGINEERING SO THE
FACULTY NUMBERS ROW FLECT THE
PH.D. NUMBERS, THE PH.D. NUMBERS
REPRESENT THE STUDENTS.
THE VALIDATION OF MANY OF THESE
TECHNOLOGIES, WE KNOW CULTURALLY
IT CAN TAKE A WHILE FOR THESE
ADVANCES TO MOVE, AND OVERALL,
WE NEED TO BE INNOVATIVE IN THE
OPPORTUNITIES THAT WE CREATE.
SO WE TALKED ABOUT THE RADX
PROGRAM.
THESE ARE ALTERNATIVE PATHWAYS
TO HELP STIMULATE INNOVATION,
COMMERCIALIZATION, AND
PARTICIPATION, EASIER
PARTICIPATION IN THE DEVELOPMENT
OF THESE TECHNOLOGIES FOR
WOMEN'S HEALTH.
SO WITH THAT, I WILL WRAP IT UP.
>> THANK YOU SO MUCH, BRUCE.
I'M NOT SURE WHAT TO SAY.
THAT WAS AN INCREDIBLY
COMPREHENSIVE PICTURE OF
OPPORTUNITIES, OF ADVANCES, OF
PROMISE, AND ALL THE INCREDIBLE
WORK THAT NIBIB IS LEADING IN
THIS SPACE COLLABORATIVELY
ACROSS NIH.
WE ARE A LITTLE OVER, SO LET ME
ASK IF THERE ARE ANY COMPELLING
QUESTIONS.
DR. ANDERSON HAS A QUESTION, I
CAN TELL.
>> THANK YOU.
IT WAS REALLY EXCITING TO SEE
ALL OF THIS AND THE PROGRESS IN
HAVING WOMEN IN THE FIELD AND
PUSHING THIS IS JUST REALLY
REWARDING.
I HAVE ONE SIMPLE QUESTION.
WHAT FRACTION OF THE BIOMEDICAL
ENGINEERING DEPARTMENTS ARE LED
BY WOMEN?
>> OH, GOSH.
YOU KNOW, THAT'S A QUESTION YOU
COULD ASK PERHAPS SUSAN
MARGULIES, WHO'S COMING LATER,
AND WHO, IN FACT, HAS LED TWO
BIOENGINEERING DEPARTMENTS
HERSELF AND IS VERY IN TUNE WITH
THAT, AND NOW LEADS THE NATIONAL
SCIENCE FOUNDATION'S ENGINEERING
DIRECTORATE.
BUT SEVERAL OF THEM ARE ON NIGH
NATON MYNATIONAL ADVISORY COUNC.
I THINK IT'S -- I DON'T WANT TO
GIVE YOU A HARD NUMBER, BUT IT'S
SIGNIFICANT, I THINK.
>> I ASK BECAUSE, YOU KNOW, IN
THE MEDICAL FIELD, WE HAVE
SOMEWHAT OF A FALLOFF OF WOMEN
HE HIGHER LEVELS OF LEADERSHIP,
SO I'M JUST WONDERING WHETHER
YOU MIGHT BE A LITTLE BEHIND IN
THAT BECAUSE YOUR WOMEN ARE JUST
COMING INTO THAT, BUT SOMETHING
TO PAY ATTENTION TO.
>> WELL, AND YOU KNOW, ANOTHER
THING, AND EVEN KIND OF AT
ANOTHER LEVEL, WE SEE MANY
WOMEN, BIOMEDICAL ENGINEERS,
TAKING LEADERSHIP POSITIONS AT
THE DEAN LEVEL IN SCHOOLS OF
ENGINEERING.
AND SO LONG TIME COLLEAGUE OF
MINE, NANCY, THE DEAN OF THE
UNIVERSITY OF WASHINGTON, -- SO
NOT JUST BIOENGINEERING, THEY
ARE NOW LEADING BROADER EFFORTS
IN ENGINEERING.
THREE OF THE PAST PRESIDENTS OF
THE AMERICAN INSTITUTE OF
MEDICAL AND BIOLOGICAL
ENGINEERING ARE WOMEN.
SO WE'RE SEEING CERTAINLY
GROWTH -- BUT THIS IS ALL
ANECDOTAL.
>> DR. TEMPLETON, DO YOU HAVE A
QUESTION ONLINE?
>> YEAH, YOU THAT VERY MUCH.
IT WAS AN AMAZING PRESENTATION.
REALLY, I'M OVERWHELMED WITH THE
AMOUNT OF WORK THAT YOU'RE
DOING.
>> THANK YOU.
>> BUT A QUESTION ABOUT THE
UNDERGRADUATES THAT ARE DOING
TEASE PROJECTS, WHICH ARE
AMAZING.
IS THERE AN EDUCATION PROGRAM OR
MODULE OR SOME SORT OF OUTREACH
TO THESE STUDENTS AHEAD OF TIME
TO TALK ABOUT THE EXPANSE OF
WOMEN'S HEALTH SO THEY CAN SEE
ALL OF THE BREADTH OF CONDITIONS
THAT COULD BE INCLUDED?
BEYOND THE TRADITIONAL VIEWS OF
WOMEN'S HEALTH INTO THINGS SUCH
AS OSTEOPOROSIS, PULLS,
FRACTURES, OSTEOARTHRITIS,
CHRONIC PAIN, ARE THEY LEARNING
ABOUT WOMEN'S HEALTH AND THEN
COMING UP WITH PROJECTS OR HOW
IS THAT HAPPENING?
>> NO, THAT'S GREAT QUESTION,
AND I THINK THAT'S THE MISSION
THAT JANINE AND I ARE ON, WITH
THIS KIND OF EFFORT TO REALLY
KIND OF BRIDGE OUR COMMUNITIES
IN A SYSTEMATIC AND THOUGHTFUL
WAY.
SO IT'S A TERRIFIC SUGGESTION TO
INTEGRATE THAT IN EDUCATION.
ONE OF THE THINGS THAT'S -- IF
YOU'RE A BIOMEDICAL ENGINEERING
DEPARTMENT AND YOU DON'T HAVE A
BIODESIGN PROGRAM WITH
SIGNIFICANT INSTRUCTION ON HOW
YOU DEVELOP DEVICES, HOW YOU
MOVE THEM THROUGH THE
AUTHORIZATION PROCESS, AND HOW
YOU SECURE AND RAISE FUNDING FOR
YOUR IDEAS AND CONTINUED GROWTH.
AT THE UNDERGRADUATE LEVEL, THEN
YOU'RE NOT GOING TO GET STUDENTS
WHO COME.
SO I THINK THAT WOULD BE A VERY
ATTRACTIVE PIECE THAT SHOULD BE
INTEGRATED INTO THE ENGINEERING
CURRICULUM, AND I'LL HAVE MORE
OF A DISCUSSION WITH THAT IN OUR
TRAINING DIVISION AND SORT OF
IMAGINE HOW WE COULD DO THAT.
>> THAT'S GREAT BECAUSE THAT
MIGHT ATTRACT EVEN MORE WOMEN TO
THE FIELD IF THEY COULD SEE THE
LINK BETWEEN EVERYTHING THAT
COMPRISES WOMEN'S HEALTH.
THANK YOU.
>> YEAH, THANK YOU.
AND I SHOULD ALSO EMPHASIZE HOW
THESE DESIGN PROJECTS ARE
SELECTED, LIKE THE STUDENTS
THEMSELVES ARE -- THEY ARE
THINKING THROUGH THE IDEAS AND
SYSTEMATICALLY GOING AROUND AND
INTERVIEWS PEOPLE THROUGH A VERY
SYSTEMATIC PROCESS TO UNDERSTAND
THE NEED AND ENGAGING.
SO THERE ARE MULTIPLE WAYS THAT
THESE THINGS DO COME ABOUT.
>> THANKS, KIM.
DR. NOEL?
>> HI, ALEXANDRA NOEL.
VERY NICE PRESENTATION.
YOU MENTIONED ABOUT THE
POSTPARTUM WEARABLE OR SENSORS
THAT ARE AVAILABLE FOR WOMEN AND
YOU TALKED ALSO A LOT ABOUT
FETAL MONITORING IN TERMS OF
BIOLOGICAL OUTCOMES.
I WAS WONDERING IF THERE ARE ANY
PROJECTS THAT ARE ALSO LOOKING
AT WEARABLE SENSORS FOR PREGNANT
WOMEN TO LOOK AT EXPOSURE
ASSESSMENT, FOR EXAMPLE, WITH
AIR POLLUTION BECAUSE THAT HAS A
GREAT -- WE KNOW THAT THAT CAN
AFFECT THE GENE ENVIRONMENT
INTERACTION AND THAT COULD ALSO
AFFECT THE OFFSPRING OR THE
NEONATE, SO JUST WONDERING.
>> NO, I FEEL LIKE AT SOME POINT
IN THE FUTURE, THE EXPOSOME IS
GOING TO BE PART OF OUR
ELECTRONIC HEALTH RECORD.
HOW ARE WE GOING TO GET THERE?
I THINK THE ONLY THING I KNOW
FOR SURE IS WE'VE GOT TO ENGAGE
THE ENGINEERING COMMUNITY AND
THE DIRECTOR OF NIEHS, RICK
WOYCHIK, HAS GIVEN A QUITE
INSPIRATIONAL TALK AT NIBIB
EXACTLY ALONG THOSE LINES
SAYING, OKAY, YOU GUYS, SH WE'VE
GOT TO COME UP WITH SYSTEMATIC
AND POTENTIALLY WEARABLE
APPROACHES TO GET MEASURABLE
FEATURES AT THE EXPOSOME THAT WE
CAN INTEGRATE INTO THE HEALTH
RECORD OF INDIVIDUALS AND --
OUTCOMES RELATED TO THOSE
THINGS.
WHAT DO WE NEED TO INTEGRATE?
IT'S MORE COMPLICATED THAN THE
APPLE WATCH, I THINK WE CAN SAY
THAT, BUT IT'S NOT AS
COMPLICATED AS SOME OF THOSE
THINGS THAT I SHOWED YOU TODAY.
SO THIS IS GOING TO REQUIRE
COMMUNITY EFFORT.
PHYSICIANS WORKING WITH
ENGINEERS TO SAY, THESE ARE
IMPORTANT THINGS TO MEASURE.
WE NEED TO UNDERSTAND, BECAUSE
WE CAN MEASURE ANYTHING.
AND SO REALLY TEASING THAT OUT
AND GETTING THE ENVIRONMENTAL
SCIENCE COMMUNITY, ENVIRONMENTAL
HEALTH COMMUNITY TO FOCUS IN,
BECAUSE THE EXPOSOME IS
EVERYTHING, AND IT CAN BE QUITE
OVERWHELMING.
BUT I AM CONFIDENT THAT AT SOME
POINT IN THE FUTURE, IT'S GOING
TO BE PART OF OUR EHR THAT'S
GOING TO BE CRITICALLY
IMPORTANT.
>> THANK YOU FOR THIS AMAZING
PRESENTATION.
BECAUSE TIME IS SHORT, I WON'T
ANSWER ANY OF THOSE COMMENTS BUT
I'LL FOLLOW UP WITH YOU BECAUSE
THERE ARE SEVERAL CONNECTION
POINT.
>> I'LL BE HANGING AROUND, SO IF
FOLKS HAVE SOME QUESTIONS, I'M
HAPPY TO TALK.
>> THANK YOU SO MUCH,
DR. TROMBERG.
WE APPRECIATE YOUR PRESENTATION.
[APPLAUSE]
IT'S NOW MY PLEASURE TO
INTRODUCE OUR NEXT SPEAKER,
DR. MATT MCMAHON, WHO'S THE
DIRECTOR FOR THE NIH SMALL
BUSINESS EDUCATION AND
ENTREPRENEURIAL DEVELOPMENT OR
SEED OFFICE.
HE LEADS THE SEED OFFICE IN
HELPING TO TRANSFORM CUTTING
EDGE TECHNOLOGIES INTO PRODUCTS
TO IMPROVE HEALTH AND SAVE
LIVES.
HE HAS A DIVERSE BACKGROUND IN
ACADEMIA OF SMALL BUSINESSES,
CONGRESSIONAL POLICY, AND NIH
PROGRAM MANAGEMENT, AND HE
PREVIOUSLY SERVED AS THE FIRST
DIRECTOR OF NHLBI'S OFFICE OF
TRANSLATIONAL ALLIANCES AND
COORDINATION, AND HE CREATED THE
NEI OFFICE OF TRANSLATIONAL
RESEARCH.
SO PLEASE HELP ME WELCOME
DR. MATT MCMAHON.
>> WELL, THANK YOU VERY MUCH FOR
INVITING ME.
IT'S REALLY A GREAT OPPORTUNITY
TO BE HERE AND TALK TO THIS
ADVISORY COUNCIL, AND TO BUILD
SOME MORE BRIDGES BETWEEN THE
COMMUNITIES THAT WE REPRESENT,
BECAUSE WE HAVE MANY OVERLAPPING
GOALS.
ONE OF THE THINGS THAT I LIKE TO
POINT OUT IS THAT MANY PEOPLE
UNDERSTAND NIH AS BEING THE
FOUNDATION OF BASIC BIOMEDICAL
RESEARCH IN THE UNITED STATES.
BUT IT'S ALSO IMPORTANT TO NOTE
THAT THE MISSION OF THE NIH IS
NOT JUST TO SEEK FUNDAMENTAL
KNOWLEDGE ABOUT THE NATURE AND
BEHAVIOR OF LIVING SYSTEMS, BUT
ALSO TO APPLY THAT KNOWLEDGE TO
ENHANCE HEALTH, LENGTHEN LIFE
AND REDUCE ILLNESS AND
DISABILITY.
SO THAT APPLICATION OF THE BASIC
BIOLOGICAL KNOWLEDGE THAT WE
GENERATE THROUGH ALL OF THE
RESEARCH THAT WE FUND ACROSS THE
COUNTRY IS A CRITICAL PART OF
WHAT WE'RE TRYING TO DO.
THE SEED OFFICE IS A RELATIVELY
NEW PLAYER ON THE SCENE.
THE SEED OFFICE WAS FOUNDED AT
NIH AROUND 2019, AND THE REASON
THAT THE SEED OFFICE WAS FOUNDED
IS BECAUSE ALL ACROSS THE
DIFFERENT INSTITUTES AND CENTERS
AT NIH, THERE WAS AN INKREASING
UNDERSTANDING OF THE NEED TO
HELP INVESTIGATORS UNDERSTAND
ALL THE STEPS THEY WOULD NEED TO
TAKE TO BRIDGE THE GAP BETWEEN
BASIC SCIENTIFIC DISCOVERIES IN
THAT APPLICATION OF THOSE
DISCOVERIES TO IMPROVE LOU MAN
HEALTH.
SO THERE WERE A NUMBER OF MODELS
THAT WERE GENERATED AT THE
DIFFERENT INSTITUTES AND CENTERS
THAT LED TO THE FORMATION OF THE
SEED OFFICE, BUT WHAT THE SEED
OFFICE ESSENTIALLY IS, IS A
IN-HOUSE COMMERCIALIZATION
ASSISTANCE UNIT, AN IN-HOUSE
PRODUCT DEVELOPMENT ASSISTANCE
SERVICE.
SO WITHIN OUR OFFICE, WE HAVE A
TEAM OF ENTREPRENEURS AND
RESIDENTS WHO HAVE DEEP
EXPERIENCE IN THE BUSINESS AND
COMMERCIAL SECTOR.
MANY OF THEM HAVE STARTED THEIR
OWN BUSINESSES.
MANY OF THEM HAVE WORKED IN
INDUSTRY, AND THEY UNDERSTAND
HOW TO WORK AT THAT INTERFACE OF
SCIENCE AND TECHNOLOGY AND
PRODUCT DEVELOPMENT.
WE HAVE ALMOST TENANT PRE NEWERS
AND RESIDENTS NOW.
OVER OVER HALF OF THEM ARE
WOMEN.
SOME HAVE DEEP EXPERIENCE IN THE
FEMTECH DEVELOPMENT SPACE.
WE ALSO HAVE AN IN-HOUSE
REGULATORY TEAM THAT HELPS
PEOPLE UNDERSTAND THE BARRIERS
TO FDA APPROVAL AND MARKETING
APPROVAL.
AND WE ALSO HAVE A TEAM THAT
HELPS UNDERSTAND -- HELPS
INVESTIGATORS PLAN AND
UNDERSTAND THE CHALLENGES OF THE
BUSINESS PROCESSES THAT ARE
NECESSARY TO GET YOUR PRODUCT
PAID FOR IN THE COMPETITIVE
HEALTHCARE MARKETPLACE.
THAT'S REALLY A CRITICAL PART OF
GETTING THESE TECHNOLOGIES INTO
THE HANDS OF CLINICIANS, AND
FAMILY MEMBERS THAT NEED TO USE
THEM, IS HOW ARE THOSE DEVICES
AND THOSE TREATMENTS GOING TO BE
PAID FOR.
SO OUR TEAM, YOU CAN THINK OF
OUR TEAM AS A KIND OF ASSISTANCE
SERVICE THAT CAN WORK ACROSS ALL
THE DIFFERENT DOMAINS THAT NIH
WORKS IN TO HELP PEOPLE MAKE
THAT TRANSFORMATION BETWEEN
SCIENTIFIC DISCOVERY AND
BUSINESS DEVELOPMENT.
SO WHAT I WANT TO TALK ABOUT
TODAY IS REALLY THAT
INTERSECTION OF WHAT SEED DOES,
WHAT OUR OFFICE DOES, AND THE
PART OF THE NIH OFFICE OF
RESEARCH ON WOMEN'S HEALTH AND
THAT PLAN THAT DR. CLAYTON
TALKED ABOUT TO REALLY TAKE
THOSE ADVANCES AND THAT
KNOWLEDGE THAT'S BEING GENERATED
AND APPLY THAT TO THE WOMEN'S
HEALTH CHALLENGES THAT EXIST IN
THE HEALTHCARE MARKETPLACE.
SO AN INTEGRAL PART OF THAT THAT
DR. TROMBERG TALKED ABOUT QUITE
A BIT WAS THE INTERSECTION WITH
THE BIOMEDICAL WORKFORCE AND THE
ROLE THAT INCREASING DIET VERSE
IT OF THE BIOMEDICAL WORKFORCE
PLAYS IN ACHIEVING THOSE GOALS.
SO I'LL TALK A LITTLE BIT ABOUT
THAT ALSO.
SO LET ME SET THINGS UP A LITTLE
BIT BY TALKING ABOUT THE
INVESTMENT ENVIRONMENT AND THE
PRODUCT DEVELOPMENT ENVIRONMENT
IN THE WOMEN'S HEALTH SECTOR,
BECAUSE I THINK THAT WE'RE IN A
REALTIMEREAL TIME OF OPPORTUNITD
THERE ARE CHALLENGES, MANY
CHALLENGES, BUT STARTING ABOUT
PROBABLY EVEN BEFORE 2020 THERE
WAS STARTING TO BE AN INCREASING
APPRECIATION FOR THE UNMET --
NOT ONLY THE UNMET MEDICAL
NEEDS, BUT THE MARKET
OPPORTUNITIES THAT EXISTED IN
THE WOMEN'S HEALTH SECTOR.
SO THERE'S NOT ONLY A LARGE
MARKET OPPORTUNITY, BUT AT THAT
TIME THE -- CONDUCIVE REGULATORY
ENVIRONMENT, THERE WERE ALSO
INVESTMENT FIRMS, VENTURE
CAPITAL FIRMS AND ANGEL
INVESTORS WHO WERE VERY
INTERESTED IN, WOULDING IN THI S
SECTOR BUT AT THE SAME TIME
THERE WAS AN INCREASE IN FUNDING
GOING INTO PREVENTIVE MEDICINE
AND HOLISTIC HEALTH, AND AN
INCREASING APPRECIATION OF THE
ROLE OF HEALTH I.T. AND AI AND
MACHINE LEARNING ADVANCES, AND
ALL THESE THINGS WERE WORKING
TOGETHER TO INKREAS THE INCREASE
OPPORTUNITY FOR THESE EARLY
STAGE PROJECTS TO ACTUALLY TURN
INTO USEFUL PRODUCTS AND
SERVICES.
SILICON VALLEY BANK IN 2023
RELEASED A REPORT THAT MADE SOME
PREDICTIONS ABOUT WOMEN'S HEALTH
INNOVATION, AND I THINK THEY'RE
VERY IMPORTANT TO JUST REVIEW
THEM BECAUSE ONE OF THE THINGS
THAT WE'RE SEEING IN NOT ONLY
OUR PORTFOLIO BUT BROADLY IN THE
INNOVATION SPACE IS THAT THERE'S
A GROWTH IN NON-REPRODUCTIVE
FOCUS AREAS, AND YOU'VE HEARD A
LITTLE BIT ABOUT THAT ALREADY
TODAY.
THIS IS MORE INTEREST IN
PHYSICAL AND MENTAL WELL-BEING
IN WOMEN'S HEALTH, AND ALSO MORE
INTEREST IN CARE ACROSS THE
WHOLE LIFETIME.
SO THAT COULD BE INCREASES IN
ATITIATTENTION TO -- OR MENOPAUD
WOMEN'S HEL LATER IN LIFE.
SO THESE ARE A FEW OF THE THINGS
THAT WERE BEING BROUGHT TO THE
FOREFRONT IN THE INVESTMENT
WORLD.
ALSO THERE WERE MANY MORE --
MUCH MORE ACTION IN THE CLINICAL
SPACE, INCREASES IN CLINICAL
RESEARCH, INCREASES IN
DIAGNOSTIC AND DEVICE
DEVELOPMENT AND THERAPEUTICS
THAT WERE FOCUSED ON WOMEN'S
HEALTH.
AND ALSO THE VENTURE CAPITAL
COMMUNITY WAS PUMPING MORE MONEY
INTO WOMEN'S HEALTH-RELATED
PROJECTS, AND WE'RE STARTING TO
SEE A LITTLE BIT OF A
TRANSFORMATION IN THAT FUNDING.
SO IT'S PART OF THE NORMAL
LIFECYCLE OF THE INVESTMENT
WORLD WHERE IN EMERGING STAGES
OF AN AREA, THERE'S MUCH MORE
FUNDING IN THE VENTURE STAGE OF
THE PROJECTS AND AS THE FIELD
STARTS TO MATURE, THE VENTURE
CAPITAL INVESTORS START TO SHIFT
THEIR FOCUS TO LATER STAGE
RESEARCH PROJECTS.
AND I THINK IT'S A TESTAMENT TO
THE INTEREST IN WOMEN'S HEALTH
THAT THE VENTURE COMMUNITY IS
STARTING TO SHIFT THOSE
INVESTMENTS TO LATER STAGE
PROJECTS AS THE FIELD STARTS TO
MATURE AND BECOME MORE WELL
ESTABLISHED.
SO I THINK THAT'S REALLY LAYING
OUT A FIELD OF OPPORTUNITY IN
WOMEN'S HEALTH.
THE WORLD ECONOMIC FORUM
RELEASED THIS REPORT IN JANUARY
WHERE THEY WERE TALKING ABOUT
CLOSING THE WOMEN'S HEALTH GAP,
AND THIS, I THINK, ILLUSTRATES
THE DUAL NATURE OF THE SITUATION
THAT WE'RE IN.
ON THE ONE HAND, THERE IS A
TREMENDOUS GAP IN WOMEN'S
HEALTH, BUT AT THE SAME TIME,
THAT PRESENTS A MARKET
OPPORTUNITY THAT MARKET FORCES
CAN COME IN AND ADDRESS.
SO ALTHOUGH WOMEN LIVE LONGER
THAN MEN, THEY SPEND 25% MORE OF
THEIR TIME IN POOR HEALTH THAN
MEN, AND THAT OPPORTUNITY REALLY
CREATES A CHALLENGE FOR THE
INNOVATION COMMUNITY TO GO
AFTER.
THE ROOT CAUSES OF THIS GAP IN
THIS REPORT THAT WERE IDENTIFIED
WERE SCIENCE, DATA, CARE
DELIVERY, AND INVESTMENT.
AND AS I MENTIONED BEFORE, THERE
THERETHERE'S SO MUCH ACTIVITY IE
INVESTMENT SPACE, IN THE WOMEN'S
HEALTH SPACE, AND AS
DR. TROMBERG MENTIONED,
INCREASING -- AND DR. CLAYTON,
INCREASING INVESTMENTS AND
ATTENTION TO THESE OTHER AREAS
OF BASIC SCIENTIFIC RESEARCH AND
DATA AND CARE DELIVERY THAT ARE
ALL GOING TO CONTRIBUTE TO
INCREASES IN PRODUCT DEVELOPMENT
AND INNOVATION IN THIS SPACE.
ON THE INVESTMENT SIDE, YOU CAN
SEE HERE THERE'S A TR TREMENDOUS
AMOUNT OF CAPITAL THAT HAS BEEN
DEVOTED TO WOMEN'S HEALTH
PRODUCTS AND WOMEN'S HEALTH
SERVICES, AND AN INCREASING
ATTENTION TO THOSE AREAS IN THE
INVESTMENT WORLD.
SO I THINK THAT'S REALLY
CHANGING THE LANDSCAPE FROM A
DECADE AGO, WHERE A DECADE AGO,
THERE WAS A GREAT UNMET MEDICAL
NEED, BUT THERE WAS NOT A MARKET
OPPORTUNITY, THERE WASN'T AN
OPPORTUNITY FOR THOSE PRODUCTS
TO BE DEVELOPED ALL THE WAY TO
THE HEALTHCARE MARKETPLACE,
WHEREAS NOW, WE GO TO INVESTMENT
MEETINGS AND ATTEND INVESTMENT
MEETINGS ALL THE TIME, AND IT'S
NOT UNCOMMON NOW TO SEE PITCH
COMPETITIONS THAT ARE FOCUSED
JUST ON WOMEN'S HEALTH PRODUCTS
AND SERVICES, AND THAT'S BECAUSE
THERE'S A GREAT DESIRE IN THE
INVESTMENT WORLD TO ATTACK THESE
ISSUES.
SO THAT'S JUST A BRIEF PICTURE
OF THE INVESTMENT AND PRODUCT
DEVELOPMENT LANDSCAPE AROUND
WOMEN'S HEALTH, AND I THINK IT'S
A GREAT WAY TO KIND OF LAY THE
FOUNDATION FOR WHERE NIH FITS
INTO THE PICTURE.
SO AT THE TOP OF THE SLIDE, YOU
CAN SEE THAT -- AND MANY OF YOU
DON'T NEED TO BE REMINDED THAT
IT'S A LONG ROAD BETWEEN BASIC
RESEARCH DISCOVERIES AND YOUR
ABILITY OR YOUR FAMILY MEMBERS'
ABILITY TO RECEIVE A PRODUCT OR
SERVICE IN THE DOCTOR'S OFFICE.
THAT'S PART OF THE REASON WHY I
GOT INTO THE LINE OF WORK THAT
I'M IN, IS THAT I WAS CONSTANTLY
FRUSTRATED BETWEEN -- BY SEEING
THESE AWESOME SCIENTIFIC
ADVANCES AND SEEING THOSE
SCIENTIFIC ADVANCES FAIL AS THEY
CROSS THE SPECTRUM FROM BASIC
RESEARCH THROUGH PROOF OF
CONCEPT, RESEARCH AND
DEVELOPMENT, THEIR
TRANSFORMATION INTO ACTUAL
HEALTHCARE PRODUCTS AND
SERVICES, AND THEN NOT ONLY
THAT, THEIR DISSEMINATION AND
IMPLEMENTATION AND THEIR ABILITY
IN THE HEALTHCARE MARKETPLACE.
AND NOT ONLY IS THAT CHALLENGE
THERE FOR ALL TYPES OF PRODUCT
AND SERVICES, BUT THE TREMENDOUS
HEALTH DISPARITIES THAT WE SEE
IN THE UNITED STATES ARE ALSO A
PART OF THAT PROBLEM.
SO THE PRODUCTS AND SERVICES
THAT ARE NECESSARY TO REACH
COMMUNITIES THAT ARE IN GREATEST
NEED ARE OFTENTIMES THE ONES
THAT ARE MOST CHALLENGING TO
BRING TO THE COMMERCIAL
MARKETPLACE.
SO WHAT I'M GOING TO TALK A
LITTLE BIT ABOUT TODAY IS A FEW
OF NIH'S PROGRAMS THAT HELP AT
DIFFERENT STAGES OF THIS PRODUCT
DEVELOPMENT LIFECYCLE, AND HOW
WOMEN'S HEALTH AND A FOCUS ON
WOMEN'S HEALTH IS REALLY BEING
FACILITATED BY THESE PROGRAMS.
YOU CAN SEE HERE I'M GOING TO
TALK ABOUT TWO DIFFERENT
PROGRAMS.
ONE IS THE REACH PROGRAM WHICH
IS SITTING IN THE ACADEMIC SPACE
AT THE EARLIEST STAGE OF PRODUCT
DEVELOPMENT, AND THEN THE NEXT
ONE IS THE SMALL BUSINESS
PROGRAM, WHICH IS REFERRED TO AS
AMERICA'S SEED FUND, WHICH FUNDS
SMALL BUSINESSES ALL ACROSS THE
UNITED STATES TO EARLY STAGE
PRODUCT DEVELOPMENT.
SO THE REACH PROGRAM, OR
RESEARCH EVALUATION AND
COMMERCIALIZATION HUBS, IS A
PROGRAM THAT HELPS ACADEMIC
INVESTIGATORS CONVERT THEIR
SCIENCE PROJECTS INTO PRODUCT
DEVELOPMENT PROJECTS WITHIN THE
ACADEMIC SPACE.
AND MANY ACADEMIC RESEARCHERS
STRUGGLE WITH THIS ISSUE BECAUSE
THERE'S A GREAT GAP BETWEEN THE
SKILLS AND THE PROCESSES AND THE
LANGUAGE AND THE TERMINOLOGY
THAT'S NECESSARY TO BE
SUCCESSFUL IN THE ACADEMIC
WORLD, AND THOSE SAME SKILLS AND
LANGUAGE AND TERMINOLOGY THAT
ARE NECESSARY TO BE SUCCESSFUL
IN THE BUSINESS AND
ENTREPRENEURIAL WORLD.
SO WHAT THE REACH PROGRAM TRIES
TO DO IS ALLOW ACADEMIC
INVESTIGATORS TO STRENGTHEN
THOSE PROJECTS AND MAKE THEM AS
ATTRACTIVE AS POSSIBLE FOR
COMMERCIAL DEVELOPMENT AND TO
CONVERT THEM INTO PRODUCT
DEVELOPMENT PROJECTS.
SO THE FIRST THING THEY DO IS,
THESE HUBS PROVIDE FUNDING FOR
PRODUCT VALIDATION PROJECTS.
SO THAT IS ONE OF THE GREATEST
NEEDS THAT PEOPLE HAVE, BECAUSE
ONCE YOU TRANSITION TO EARLY
STAGE PRODUCT DEVELOPMENT, THOSE
PROJECTS ARE OFTENTIMES NOT
DISCOVERY-BASED SCIENTIFIC
PROJECTS THAT ARE EASILY FUNDED
BY R01 RESEARCH AWARDS, SO
INVESTIGATORS FIND THEMSELVES
WITH NO FUNDING TO DO THOSE
EARLY STAGES OF PRODUCT
VALIDATION.
SO THESE HUBS PROVIDE UP TO
$100,000 FOR PRODUCT VALIDATION
PROJECTS.
BUT THEY ALSO HELP INVESTIGATORS
MANAGE THOSE PROJECTS NOT LIKE A
BASIC RESEARCH GRANT, BUT BY AN
INDUSTRY-STYLE MILESTONE-BASED
PROJECT MANAGEMENT APPROACH.
THAT WILL REALLY TAKE THEM
THROUGH THE STEPS NECESSARY TO
MOVE THAT PROJECT TOWARD PRODUCT
DEVELOPMENT.
AND THE WAY THAT WE DO THAT IS
THROUGH PROVIDING
ENTREPRENEURIAL TRAINING AND
MENTORING, AND ALSO BY PROVIDING
THOSE PROJECTS WITH PERSONALIZED
FEEDBACK FROM OUR GOVERNMENT
PARTNERS LIKE THE FDA, THE
CENTER FOR MEDICAID AND MEDICARE
SERVICES, THE PATENT AND
TRADEMARK OFFICE, AND OTHER
INDUSTRY VETERANS WHO HAVE
REALLY HAD EXPERIENCE MOVING
THROUGH THIS DPROW PRODUCT DEVET
PATHWAY.
THIS PROGRAM WAS AUTHORIZED BY
CONGRESS IN 2011.
WE STARTED WITH THREE CENTERS
FUNDED BY THE NATIONAL HEART,
LUNG AND BLOOD INSTITUTE, BUT WE
FOLLOWED THAT IN 2015 BY FUNDING
THREE CENTERS THAT WERE COVERING
THE ENTIRE NIH MISSION SPACE.
AND FIVE MORE IN 2019.
NOW, THESE CENTERS AND THESE
PRINCIPLES THAT ARE LAID OUT
HERE ARE ACTUALLY VERY SIMILAR,
IF NOT IDENTICAL, TO THE
PRINCIPLES OF THE POINT OF CARE
TECHNOLOGY RESEARCH NETWORK THAT
DR. TROMBERG TALKED ABOUT.
SO THESE PRINCIPLES OF HOW TO
HELP AN INVESTIGATOR NOT --
INVESTIGATORS KNOW HOW TO VAL
VALIDATE THE TECHNOLOGY AND
VALIDATE THE SCIENCE.
THAT'S THE BREAD AND BUTTER OF
WHAT ACADEMIC INVESTIGATORS DO.
BUT THE BASICS OF WHAT THIS
REACH NETWORK DOES ALSO ALLOWS
INVESTIGATORS TO VALIDATE THE
BUSINESS AND COMMERCIAL AND
HEALTHCARE POTENTIAL OF THOSE
TECHNOLOGIES IN PARALLEL WITH
WORKING ON THE TECHNOLOGY
DEVELOPMENT.
AND THAT'S REALLY CRITICAL TO
MAKING SURE THAT THESE
TECHNOLOGIES DON'T DROP OUT AS
THEY PROCEED IN DEVELOPMENT.
IN 2023, WE FUNDED FIVE NEW HUBS
ACROSS 12 STATES AND MORE THAN
75 INSTITUTIONS, AND WHAT WE
REALLY TRIED TO DO IN THIS
LATEST ROUND OF REACH HUBS WAS
SPREAD THIS KNOWLEDGE IN THIS MO
MODEL TO PART OF THE COUNTRY
WHERE IT'S NOT COMMON.
EVERYBODY KNOWS THAT IF YOU GO
TO BOSTON OR SAN FRANCISCO, OR
NEW YORK CITY, THERE'S A CULTURE
OF INNOVATION AND OF PRODUCT
DEVELOPMENT, AND A REAL
INTERSECTION OF THE BUSINESS
WORLD AND THE ACADEMIC AND
ACADEMIC MEDICAL CENTER
ENVIRONMENT.
BUT WHAT WE'RE TRYING TO DO IS
TAKE THESE PRINCIPLES AND THESE
PROCESSES THAT WE'VE PROVED OUT
IN THESE OTHER HUBS AND MOVE
THEM TO PART OF THE COUNTRY
WHERE THEY'RE NOT COMMON, WHERE
THERE'S NOT A CONDUCIVE
INVESTMENT ENVIRONMENT, OR
BUSINESS ENVIRONMENT FOR BIOTECH
AND BIOMEDICAL AND LIFE SCIENCE
DEVELOPMENT.
SO YOU CAN SEE HERE THE FIVE
HUBS WE FUNDED RECENTLY.
MANY OF YOU IN THE ROOM ARE
PROBABLY AT INSTITUTIONS THAT
ARE SUPPORTED BY ONE OF THESE
REACH HUBS, AND I WOULD
ENCOURAGE YOU TO TAKE A LOOK AT
THE WEBSITE FOR THE PROGRAM AND
SEE HOW INVESTIGATORS AT YOUR
INSTITUTION MIGHT BE ABLE TO GET
INVOLVED.
ONE OF THE OTHER FOCUSES OF THIS
ROUND OF THE REACH HUBS WAS ON
THIS CHALLENGE TO DIVERSIFY THE
BIOMEDICAL WORKFORCE.
SO WE TRIED TO COVER AS MANY OF
THE IDEA STATES AS WE COULD
COVER WITH THESE HUBS, BUT ALSO
MANY OF THESE INSTITUTIONS AND
THE TYPES OF INSTITUTIONS THAT
ARE PART OF THESE HUBS ARE NOT
THE TRADITIONAL R1 RESEARCH
UNIVERSITIES.
THERE'S AN INCREASING NUMBER IN
THIS NETWORK OF HISTORICALLY
BLACK COLLEGES AND UNIVERSITIES,
OF TRIBAL COLLEGES AND
UNIVERSITIES, OF OTHER TYPES OF
MINORITY SERRING INSTITUTIONS,
BUT ALSO LOOKING BACK TO
TECHNICAL COLLEGES AND
UNIVERSITIES, TWO-YEAR COLLEGES
AND REALLY TRYING TO HELP PEOPLE
TO UNDERSTAND THIS MINDSET OF
SITTING -- OF SMOOTHING OUT THAT
TRANSITION BETWEEN SCIENCE AND
HEALTHCARE PRODUCTS, AND
INCREASING THAT PROCESS LITERACY
OF WHAT IT WILL TAKE TO BE
SUCCESSFUL AT ALL DIFFERENT
STAGES AND ALL DIFFERENT PLACES
ACROSS THE UNITED STATES.
SO THIS NETWORK IS NOT JUST
ABOUT SUPPORTING RESEARCH
PROJECTS, TECHNOLOGY DEVELOPMENT
PROJECTS, BUT IT'S ABOUT
EDUCATING PEOPLE.
AND IN THESE INITIAL ROUNDS OF
THE REACH PROGRAM, WE'VE
EDUCATED OVER 2600 INVESTIGATORS
THROUGH THE VARIOUS EDUCATIONAL
OPPORTUNITIES THAT THESE REACH
HUBS HAVE MADE AVAILABLE.
SO IT'S REALLY AN AMAZING WAY TO
SPREAD THIS METHODOLOGY AND
SPREAD THIS MINDSET INTO THE
ACADEMIC COMMUNITY.
THE PROJECTS THAT HAVE BEEN
SUPPORTED, THERE'S ABOUT 250 OF
THEM, BUT I'LL GIVE YOU A LITTLE
SAMPLE OF SOME OF THE ONES THAT
HAVE BEEN SUPPORTED THAT ARE
RELATED TO WOMEN'S HEALTH,
BECAUSE REMEMBER, THESE HUBS ARE
SUPPORTING TECHNOLOGY
DEVELOPMENT ACROSS THE ENTIRE
NIH MISSION SPACE.
SO JUST SOME EXAMPLES HERE, SO
MANY WOMEN ABANDON BREASTFEEDING
BEFORE THE INFANT TURNS SIX
MONTHS OLD.
OBVIOUSLY A WEARABLE LACTATION
DEVICE AND CHALLENGES IN THAT
AREA -- ANYONE WHO IS A PARENT
WILL UNDERSTAND THAT THIS IS AN
ONGOING CHALLENGE THAT HAS NOT
REALLY BEEN PROPERLY ADDRESSED.
ALSO ONE IN THREE INFANTS WITH
FEEDING PROBLEMS EXHIBIT MILK
REFUSAL WHEN THEY TRANSITION
FROM BREAST MILK TO BOTTLE
FEEDING, AND WE HAD A GREAT
PROJECT TO DEVELOP A CONTINGENT
MUSIC BABY BOTTLE TO ASSIST IN
THAT TRANSITION.
SO ONE OF THE THINGS THAT I JUST
WANT TO MENTION, THOUGH, AS I GO
THROUGH THESE PROJECTS IS THAT
IT NOT JUST THE TECHNOLOGY
DEVELOPMENT.
WHAT THESE INVESTIGATORS ARE
LEARNING THROUGH THE PROGRAM IS
ALSO WHAT ARE THE MARKET FORCES
THAT WILL REALLY BE NECESSARY
FOR YOU TO ADDRESS IN ORDER TO
MAKE THESE PRODUCTS AVAILABLE IN
THE MARKETPLACE.
SO EVERYBODY HEARS ABOUT SOME
KIND OF NEW FLASHY TECHNOLOGY OR
THEY READ A PRESS RELEASE ABOUT
SOME SCIENTIFIC DISCOVERY, AND
THEN MANY TIMES LATER ON, YOU
ASK YOURSELF, WHY STHAT NOT IS T
AVAILABLE FOR ME?
THERE ARE ALL THESE OTHER
FACTORS THAT NEED TO BE TAKEN
INTO ACCOUNT.
A GOOD EXAMPLE OF THIS IS
THIS -- DIRECT PCR HAS REALLY
REVOLUTIONIZED THE CLINICAL PCR
ENVIRONMENT, BUT BRIDGING THAT
GAP BETWEEN CLINICAL PCR TESTING
AND FORENSIC TESTING HAS BEEN A
REAL CHALLENGE, BECAUSE THERE'S
NO WAY TO COLLECT THE SAMPLES IN
A WAY THAT FACILITATE THEIR USE
IN THAT KIND OF CONTROLLED
TESTING ENVIRONMENT.
SO THAT PROJECT WAS LOOKING TO
DEVELOP A FORENSIC DNA SAMPLE
CHECK SCOLLECTION TOOL THAT COUP
ADDRESS THE TREMENDOUS BACKLOG
IN SEXUAL ASSAULT KITS THAT WE
SEE ACROSS THE COUNTRY.
YOU HEARD ABOUT SOME NONINVASIVE
DIAGNOSTICS FOR ENDOMETRIOSIS.
WE'RE GOING TO SEND THIS TEAM TO
NIBIB AND I HOPE THAT THEY WILL
WIN BRUCE'S PRIZE COMPETITION,
BECAUSE THEY ARE WORKING ON A
NONINVASIVE DIAGNOSTIC FOR
ENDOMETRIOSIS THAT USES
MENSTRUAL EFFLUENT, AND THE
CHANGES IN THE MENSTRUAL
EFFLUENT AS AN EARLY DIAGNOSTIC
FOR ENDOMETRIOSIS.
SO THEY WILL COME TO YOUR PRIZE
COMPETITION, BRUCE, AND
HOPEFULLY THEY WILL WIN AND WHAT
A TREMENDOUS OPPORTUNITY.
DRUGS FOR GENITOURINARY SYNDROME
OF MENOPAUSE, THIS PROJECT IS
LOOKING TO DEVELOP A RAPIDLY
ACTING LOCAL TREATMENT INSTEAD
OF SYSTEMIC ESTROGEN, AND TRYING
TO UNDERSTAND THE DYNAMICS OF
THE DEVELOPMENT OF THIS PRODUCT
AS A LOCAL TOPICAL TREATMENT AS
OPPOSED TO SYSTEMIC CAUSE.
AND ANOTHER ONE THAT'S REALLY
INTERESTING AS A CASE STUDY IS
THIS VULVOVAGINAL ANTIFUNGAL
AGENT.
THAT PRODUCT HAD ALREADY BEEN
INVESTIGATED FOR USE IN HIV.
SO THERE WAS SOME TOXICITY DATA
THAT WAS AVAILABLE AND HAD BEEN
USED IN FDA FILING FOR THAT
AGENT FOR A RECTAL APPLICATION
FOR HIV.
SO THAT TOXICITY DATA THAT WAS
SUFFICIENT QUALITY FOR FDA
ALREADY EXISTED.
SO THIS THROUGH THE ASSISTANCE
OF THE REACH HUB, THOSE
INVESTIGATORS REALIZED THAT THE
PATH TO COMMERCIALIZATION WOULD
BE FASTER TO DEVELOP THEIR
PRODUCT AS A RECTAL ANTIFUNGAL
EVEN THOUGH THERE ARE MORE
PATIENTS WITH VAGINAL THAN
RECTAL FUNGAL INFECTIONS BECAUSE
OF THIS REGULATORY ADVANTAGE
THEY HAD FROM THIS PREVIOUS
DATA.
SO THAT'S JUST AN EXAMPLE OF HOW
THIS TYPE OF COMMERCIAL AND
BUSINESS EXPERTISE CAN HELP AN
INVESTIGATOR CHART THIS PATH TO
THE FASTEST WAY TO COMMERCIAL
AVAILABILITY AND TO HEALTHCARE
AVAILABILITY OF THEIR PRODUCTS.
AND ALSO IT PROBABLY GOES
WITHOUT SAYING THAT A LARGE
PERCENTAGE OF THE PRODUCTS AND
THE TECHNOLOGY DEVELOPMENT
PROJECTS THAT ARE RELATED TO
WOMEN'S HEALTH ARE IN THE CANCER
FIELD, IN BREAST CANCER, IN
OVARIAN CANCER, AND WE SEE THAT
IN OUR PORTFOLIO, IN THIS
PROGRAM ALSO.
SO IN THE ACADEMIC SPACE, WE
HAVE THE REACH HUBS IN THIS
MODEL THAT HELPS INVESTIGATORS
STRENGTHEN THEIR PROJECTS, BUT
THE BIGGEST WAY THAT NIH
SUPPORTS EARLY STAGE PRODUCT
DEVELOPMENT IS THROUGH OUR SMALL
BUSINESS PROGRAM.
AND AS DR. CLAYTON MENTIONED,
THE SBIR AND STTR PROGRAMS ARE A
CONGRESSIONALLY MANDATED PROGRAM
AND THEY ARE PROVIDING
$1.4 BILLION PER YEAR TO
AMERICAN SMALL BUSINESSES TO
DEVELOP PRODUCTS IN THE LIFE
SCIENCES.
THAT'S $1.4 BILLION A YEAR.
IT'S ACTUALLY 4% OF NIH'S
EXTRAMURAL RESEARCH BUDGET
ACROSS THE ENTIRE NIH.
IT'S A CONGRESSIONALLY MANDATED
PROGRAM.
AND THE IDEA IS TO HELP
TRANSITION THOSE TECHNOLOGIES
FROM THE ACADEMIC WORLD OR FOR
SCIENTIFIC DISCOVERY INTO EARLY
STAGE PRODUCT DEVELOPMENT AT
U.S. SMALL BUSINESSES.
AND THERE'S A NOTICE OF SPECIAL
INTEREST THAT ACTUALLY
ENCOURAGES INVESTIGATORS WHO ARE
WORKING ON WOMEN'S HEALTH
RESEARCH TO UTILIZE THE SMALL
BUSINESS PROGRAM AS A WAY TO
DEVELOP THEIR PRODUCT AND
SERVICES.
SO THE SMALL BUSINESS PORTFOLIO,
WE'RE SUPPORTING ABOUT 1400
SMALL BUSINESSES EVERY YEAR.
AND YOU CAN SEE HERE THE
BREAKDOWN OF THE TYPES OF
PROJECTS THAT ARE SUPPORTED
ACROSS THE DIFFERENT TYPES OF
PROJECTS.
SO THERE'S A LARGE NUMBER OF
PROJECTS IN RESEARCH TOOLS AND
DIAGNOSTICS, BUT WE REALLY SPAN
THE ENTIRE PRODUCT DEVELOPMENT
SPECTRUM, AND ONE OF THE THINGS
I WANT TO NOTE IS THAT THE
HEALTH INFORMATION TECHNOLOGIES,
ALTHOUGH NOW IS ONLY ABOUT 10%
OF OUR PORTFOLIO, WE'RE SEEING
THAT GROW AS MORE INTEREST IN
THAT AREA PERVADES ACROSS THE
DIFFERENT SECTORS OF HEALTHCARE.
BUT ALSO I WANT TO MAKE A POINT
HERE IN THE MAP TO THE LEFT THAT
WE ARE FUNDING SMALL BUSINESSES
ALL ACROSS THE UNITED STATES AND
ALL PARTS OF THE COUNTRY, AND
THIS $1.4 BILLION A YEAR IS
ACTUALLY THE LARGEST SOURCE OF
EARLY STAGE PRODUCT DEVELOPMENT
FUNDING IN THE COUNTRY.
SO YOU MIGHT HEAR ABOUT VENTURE
CAPITOLLISTS AND THE VENTURE
CAPITAL FOLKS AND THEY THINK
THEY CORNER THE MARKET ON
DECIDING AND SUPPORTING EARLY
STAGE PRODUCT DEVELOPMENT BUT
ACTUALLY NIH IS THE LARGEST
SUPPORTER OF EARLY STAGE PRODUCT
DEVELOPMENT IN THE COUNTRY, AND
THAT'S THROUGH THE SMALL
BUSINESS PROGRAM.
SO THREE TIMES A YEAR EVERY
YEAR, JANUARY 5TH, APRIL 5TH,
SEPTEMBER 5TH, THERE'S A RECEIPT
DATE FOR SMALL BUSINESS PROGRAM
APPLICATIONS AND WE HOPE THAT
SMALL BUSINESSES ALL AROUND THE
COUNTRY WILL COME AND CONTINUE
TO USE IT AS A MAJOR WAY TO
SUPPORT THEIR PROGRAMS.
THE OTHER THING IS, IT'S NOT
JUST THE FUNDING YOU RECEIVE
THROUGH THE SMALL BUSINESS
PROGRAM.
IN ADDITION TO THE FUNDING, YOU
GAIN ACCESS TO ALL THE
COMMERCIALIZATION SERVICES OUR
OFFICE PROVIDES AND OTHER
ADDITIONAL PROGRAMS THAT PROVIDE
COMMERCIALIZATION SUPPORT FOR
YOUR PROJECT.
SO YOU NOT ONLY GET FUNDING FOR
TECHNOLOGY DEVELOPMENT, BUT YOU
ALSO GET SUPPORT FOR BUSINESS
DEVELOPMENT, FOR INTELLECTUAL
PROPERTY, FOR MARKET ANALYSIS,
FOR REGULATORY PLANNING, FOR
INSURANCE PAYMENT OR
REIMBURSEMENT, AND ALL OF THOSE
COMPONENTS WORK TOGETHER TO HELP
PEOPLE BECOME MORE SUCCESSFUL AS
THEY MAKE IT INTO THE HEALTHCARE
MARKETPLACE.
SO WHAT'S THE FOOTPRINT OF THE
PROGRAM FOR IN THE WOMEN'S
HEALTH SPACE?
WE'RE FUNDING AT LEAST 200 SMALL
BUSINESSES, WORK ON WOMEN'S
HEALTH APPLICATIONS EVERY YEAR.
AND LIKE DR. TROMBERG TALKED
ABOUT, THIS WORD CLOUD IS BASED
ON THE TYPES OF PROJECTS, THE
TYPES OF WOMEN'S HEALTH PROJECTS
AND THE NIH STUDY SECTIONS THAT
REVIEWED THEM, AND YOU CAN SEE
HERE THAT THE WOMEN'S HEALTH
PROJECTS THAT ARE FUNDED BY THE
NIH SMALL BUSINESS PROGRAM ARE
REALLY SCATTERED ACROSS ALL OF
THE DIFFERENT AREAS THAT NIH
SUPPORTS.
FROM ENVIRONMENTAL HEALTH TO
OPHTHALMOLOGY TO DENTAL AND
CRANIOFACIAL RESEARCH, TO CANCER
WITH THE LARGEST FOOTPRINT BEING
IN CANCER, BUT YOU CAN SEE HERE
THAT THOSE PROJECTS ARE REALLY
RUNNING THE GAMUT ACROSS ALL OF
THE DIFFERENT AREAS THAT NIH
SUPPORTS.
SO THAT'S A REALLY IMPORTANT
POINT TO BE MADE BECAUSE AS WE
INCROSE OUR ATTENTION TO WOMEN'S
HEALTH, THOSE ADVANCES AND THOSE
PROJECTS CAN BE COMING THROUGH
MANY OF THE DIFFERENT INSTITUTES
AND CENTERS, NOT JUST BIOMEDICAL
IMAGING AND BIOENGINEERING OR
THE CANCER INSTITUTE, BUT
THROUGH ALL OF THOSE INSTITUTES
AND CENTERS THAT ARE WORKING IN
COLLABORATION WITH THE OFFICE OF
RESEARCH IN WOMEN'S HEALTH TO
ACHIEVE THE GOALS THAT WE'RE
TRYING TO ACHIEVE IN WOMEN'S
HEALTH.
SO I WANT TO RUN THROUGH SOME
EXAMPLES OF THESE PROJECTS IN
THE SMALL BUSINESS SPACE.
ONE OF THE PROJECT FROM A
COMPANY CALLED RIVANNA IS A
HANDHELD ULTRASOUND DEVICE FOR
EPIDURAL PLACEMENT.
THEY STILL AFFECT THOUSANDS OF
WOMEN EACH YEAR, AND I WAS
THINKING ABOUT THIS PROJECT THE
OTHER DAY BECAUSE MY MOTHER HAD
AN EPIDURAL INJECTION FOR A
STENOSIS AND SHE HAD TO GO TO AN
OUTPATIENT SURGERY CENTER AND
HAVE THAT DONE UNDER X-RAY
GUIDANCE, BUT WOULDN'T IT BE
GREAT IF THERE WAS A DEVICE THAT
COULD BE USED IN THE DOCTOR'S
OFFICE TO HELP THEM GUIDE
EPIDURAL PLACEMENT AND THAT'S
THE PRODUCT THAT RIVANNA IS
WORKING TO DEVELOP.
AND HOPEFULLY IN THE NEXT FEW
YEARS, THAT DEVICE WILL BE
AVAILABLE FOR COMMERCIAL USE.
DAREBIO IS A COMPANY WORKING ON
NON-HORMONAL BIRTH CONTROL
DEVICES.
THE FOUNDER OF THIS COMPANY, SHE
CO-FUNDED THIS COMPANY AFTER
LEAVING A WOMEN'S HEALTH
NON-PROFIT.
AND THE REASON SHE LEFT THIS
WOMEN'S HEALTH NON-PROFIT IS
BECAUSE SHE KEPT SEEING ALL
THESE WOMEN'S HEALTHCARE
PRODUCTS THAT DIDN'T HAVE A
PATHWAY TO COMMERCIALIZATION,
AND SHE THOUGHT, WELL, I CAN DO
SOMETHING ABOUT THAT IN THE
BUSINESS ENVIRONMENT MYSELF.
AND SO DARE IS NOT ONLY WORKING
ON THIS PRODUCT, BUT THEY HAVE
ANOTHER -- MANY OTHER NIH AWARDS
WORKING ON PRETERM BIRTH
PRODUCTS AND OTHER TYPES OF
CONTRACEPTIVE DEVICES.
NEAR OWECRINE BIOSCIENCE,
THEY'VE HAD DECADES OF SUPPORT.
THEY'RE A GREAT EXAMPLE OF HOW
SUSTAINED INVESTMENTS IN BASIC
SCIENCE AND SUPPORTING
TECHNOLOGY ALL THE WAY FROM
BASIC SCIENCE THROUGH EARLY
PRODUCT DEVELOPMENT IS REALLY
NECESSARY TO CRACK SOME OF THESE
PROBLEMS OPEN AND COME WITH
SOLUTIONS.
SO NEUROCRINE HAS HAD DECADES OF
SUPPORT WORKING ON THE BASIC
MECHANISMS RELATED TO
ENDOMETRIOSIS, AND THEY'VE USED
THAT UNDERLYING KNOWLEDGE TO
DEVELOP A FAST-ACTING TREATMENT
FOR ENDOMETRIOSIS.
SO IT'S JUST AN EXAMPLE OF HOW
IT'S NOT JUST THE TECHNOLOGY
DEVELOPMENT OR THE BUSINESS
DEVELOPMENT, BUT IT'S THE
INTERSECTION OF THE TWO THAT
ENABLES THESE COMPANIES TO BE
SUCCESSFUL.
BIOPSY SCIENCES, THAT'S A
COMPANY THAT FORMED WHEN TWO
SOCCER DADS GOT TO CHATTING WITH
EACH OTHER AT THE SOCCER FIELD,
ONE WAS AN ENGINEER, AND ONE WAS
A RADIOLOGIST, AND THEY GOT
TALKING ABOUT CHALLENGES IN
BREAST CANCER DIAGNOSTICS, AND
THEY FORMED A COMPANY CALLED
BIOPSY SCIENCES.
AND THIS PROJECT WAS ONE, WHEN
THEY TAKE A BIOPSY AND TEST THAT
BIOPSY, LATER ON WHEN THEY HAVE
TO GO BACK TO DO SURGERY, IT'S
VERY DIFFICULT TO KNOW THE EXACT
LOCATION OF WHERE THAT BIOPSY
WAS TAKEN.
SO OFTENTIMES A CLINICIAN WILL
HAVE TO PLACE A NEEDLE TO TRY
AND LOCATE WHERE THAT BIOPSY WAS
DONE, BUT WHAT THEY DID IS THEY
DEVELOPED A HYDROGEL MARKER THAT
THEY COULD INJECT AT THE TIME
THEY TAKE THE BIOPSY, WHICH IS
VISIBLE WITH ULTRASOUND AND
LASTS FOR LESS THAN A YEAR BUT
IS RESORBABLE THAT ALLOWS THE
CLINICIANS TO VERY EASILY LOCATE
THE PRECISE LOCATION WHERE THE
BIOPSY WAS TAKEN.
SO THAT IS A PRODUCT THAT'S
UNDER DEVELOPMENT WITH NIH
FUNDING.
AND NUGENEREX WAS A COMPANY THAT
WAS SPUN OUT OF UMASS IN THE
90s BASED ON A DISCOVERY THAT
SMALL BITS OF A TUMOR OR VIRUS
COULD BE USED TO STIMULATE THE
IMMUNE SYSTEM TO ATTACK CANCER
CELLS.
SO OVER THE YEARS, THAT BASIC
DISCOVERY WAS USED TO FORM -- TO
TEST A NUMBER OF PRODUCTS BUT
MOST RECENTLY, A TREATMENT FOR
AN AGGRESSIVE FORM OF BREAST
CANCER.
SO THIS IS JUST A SAMPLING OF
SOME OF THOSE PRODUCTS THAT ARE
COMING OUT OF THE SMALL BUSINESS
PROGRAM THAT ARE RELATED TO
WOMEN'S HEALTH.
IT'S IMPORTANT TO NOTE THAT MANY
OF THESE PROJECTS, THE VERY
FIRST INVESTMENT THAT THESE
COMPANIES RECEIVED TO DO THEIR
PRODUCT DEVELOPMENT IS FROM THE
NIH SMALL BUSINESS PROGRAM.
AND WITHOUT THAT FUNDING AND
WITHOUT THAT $1.4 BILLION OF
SUSTAINED FUNDING OVER TIME,
MANY OF THESE PROJECTS WOULD
HAVE NEVER MADE THAT TRANSITION
FROM AN IDEA OR A DISCOVERY INTO
PRODUCT DEVELOPMENT.
SO THAT'S WHY AT NIH, WE'RE
TRYING TO REALLY MAXIMIZE THE
BENEFIT OF THAT PROGRAM AND THE
DOLLARS THAT ARE AVAILABLE AND
SURROUND THOSE PROJECTS WITH ALL
THE RESOURCES THAT WE CAN
MARSHAL TO HELP THEM BE
SUCCESSFUL AS THEY MOVE FORWARD
IN THOSE EARLY STAGES.
WE REALIZE THAT THE MONEY THAT
WE'RE PROVIDING WHICH FOR ANY
ONE OF THESE SMALL BUSINESSES
COULD BE IN TOTAL UP TO 5 OR
$7 MILLION, THAT MIGHT BE -- IT
MIGHT BE A DROP IN THE BUCKET
FOR WHAT IT COULD TAKE TO GET AN
ACTUAL SAFE THERAPEUTIC ALL THE
WAY TO THE HEALTHCARE
MARKETPLACE, BUT IT'S REALLY
CRITICAL IN THOSE EARLY STAGES,
AND THE OTHER ADVANTAGE OF THIS
FUNDING IS THE MONEY THAT THEY
GET FROM THE NIH SMALL BUSINESS
PROGRAM IS FREE MONEY, IN THE
SENSE THAT THEY DON'T HAVE TO
GIVE UP A PIECE OF THEIR COMPANY
TO GET ACCESS TO THIS MONEY,
LIKE THEY DO WITH VENTURE
CAPITALISTS WHO ARE SPENDING
OTHER PEOPLE'S MONEY OR ANGEL
INVESTORS WHO ARE SPENDING THEIR
OWN MONEY, THEY'RE ABLE TO DO
THIS TECHNOLOGY DEVELOPMENT AND
MOVE THESE PROJECTS FORWARD WITH
THIS FUNDING THAT COMES FROM THE
FEDERAL GOVERNMENT.
SO THE OTHER THING I WANTED
TO -- OH, AND YOU CAN SEE ALL OF
THESE EXAMPLES THAT I'VE SHOWN
HERE, THERE ARE ONE PAGE SUCCESS
STORIES THAT ARE ON OUR SUCCESS
STORY WEBSITE THAT DESCRIBE IN
MORE DETAIL THE PATHWAY THAT
THESE COMPANIES HAVE TAKEN TO
DEVELOP THEIR PRODUCTS.
AND WE MAKE THESE ONE-PAGE
SUCCESS STORIES, THEY'RE
AVAILABLE, THEY'RE GEARED TOWARD
A GENERAL AUDIENCE FOR A FEW
REASONS, BUT ONE REASON IS
BECAUSE WE FIND THESE STORIES
ARE REALLY INSPIRATIONAL.
SO PEOPLE MIGHT THINK, OKAY,
WELL, MAYBE NIH DOESN'T REALLY
SUPPORT WOMEN'S HEALTHCARE,
PRODUCT DEVELOPMENT.
IT'S A GREAT WAY FOR PEOPLE TO
BE ABLE TO LEARN AND BE INSPIRED
BY OTHER PEOPLE'S SUCCESS, AND
BY OTHER PEOPLE'S EXPERIENCES.
SO WE HAVE A NUMBER OF
WOMEN-OWNED SMALL BUSINESSES
THAT ARE HIGHLIGHTED ON THIS
WEBSITE.
THERE'S ALMOST 100 SUCCESS
STORIES THERE NOW.
SO I WOULD ENCOURAGE YOU TO GO
AND CHECK OUT THE WEBSITE FOR
MORE INFORMATION.
NOW ANOTHER THING THAT I
MENTIONED WAS THIS INTERSECTION
WITH BIOMEDICAL WORKFORCE
DEVELOPMENT, AND IN THE SMALL
BUSINESS SPACE, WE ARE REALLY
COMMITTED TO TRAINING AND
SUPPORTING WOMEN INNOVATORS AND
WOMEN ENTREPRENEURS.
AND YOU KNOW, IT'S REALLY A
PRETTY SIMPLE IDEA WHICH IS THAT
PEOPLE ARE INTERESTED IN WORKING
ON THE ISSUES THAT AFFECT THEM
AND AFFECT THEIR COMMUNITIES AND
AFFECT THE PEOPLE THAT THEY'RE
CLOSE TO.
AND THAT'S WHAT DIVERSITY IN THE
BIOMEDICAL WORKFORCE IS ALL
ABOUT, IS BEING MORE INCLUSIVE
IN THE PEOPLE WHO WE'RE TRAINING
AND THE PEOPLE WE'RE SUPPORTING
SO THAT THOSE PEOPLE CAN ADDRESS
THE ISSUES THAT ARE IMPORTANT TO
THEM AND THAT THEY CARE ABOUT,
AND THAT'S IMPORTANT IN WOMEN'S
HEALTH ALSO.
IT TURNS OUT THAT 76% OF THE
VC-BACKED WOMEN'S HEALTH
COMPANIES HAVE AT LEAST ONE
FEMALE CO-FOUNDER.
SO THAT IS DIRECTLY RELATED TO
THE STATEMENT THAT I JUST MADE.
SO THAT'S EVIDENCE THAT
SUPPORTING WOMEN'S -- WOMEN
INNOVATORS AND SUPPORTING WOMEN
FOUNDERS IS REALLY ONE OF THE
BEST THINGS THAT WE CAN DO TO
INCREASE ATTENTION TO WOMEN'S
HEALTH PROJECTS.
SO THREE PROJECTS HERE.
THE FIRST ONE, DR. CLAYTON
MENTIONED.
THIS ONE, ANNA CONSUELO MATIANA
STARTED HER COMPANY BECAUSE SHE
NOTICED A LACK OF CULTURALLY
AWARE COMMUNE KEATION COMMUNICAS
AND OTHER PEOPLE OF COLOR, AND
ON THE BASIS OF THAT, SHE
DEVELOPED THESE PHOTO NOVELLAS
FOR DIFFERENT HEALTHCARE
CONDITIONS, AND SHE'S LEVERAGED
NIH FUNDING TO MOVE THIS PROJECT
FORWARD.
AND THIS IS ANOTHER ONE WHERE
ONE OF THE OTHER ADVANTAGES OF
NIH FUNDING IS THAT IT ALLOWS
YOU TO KIND OF MOVE A PROJECT
FORWARD THAT MIGHT NOT HAVE A
VERY STRONG INVESTMENT
HYPOTHESIS.
SO THESE ARE PROJECTS THAT HAVE
GREAT HEALTHCARE POTENTIAL, BUT
THEY MIGHT NOT HAVE THE SAME
MARKET POTENTIAL THAT OTHER
PROJECTS HAVE, SO UTILIZING NIH
FUNDING TO PUSH THEM FORWARD IS
ONE WAY TO REALLY INCREASE OUR
ABILITY TO BRING THEM INTO THE
MARKETPLACE.
THE NEXT PROJECT, RACHEL
DRILINGER, SHE WAS A BIOMEDICAL
ENGINEER FOR LIKE 20 YEARS, 20
YEARS OF ENGINEERING EXPERIENCE,
BUT SHE USED SBIR FUNDING TO
SPIN OUT AND START HER OWN
COMPANY, WHICH WAS A GREAT
CHALLENGE TO HER, NOT ONLY AS A
WOMAN ENGINEER BUT AS A NAVAJO
WOMAN ALSO, SO HER COMPANY,
NEURAMEDICA HAS BEEN DEVELOP AGO
BIOABSORBABLE CLIP THAT ENHANCES
PATIENT CARE DURING SPINAL
SURGERY.
IT'S ON ITS WAY TO
COMMERCIALIZATION.
SHE AS NOT ONLY SUCCESSFUL AS A
WOMEN BUSINESS OWNER BUT ALSO
BROUGHT IN NUMBER OF NAVAJO
INTERNS INTO HER COMPANY.
AND THEN THE FINAL EXAMPLE IS
CATHY ROLAND, SHE STRUCK OUT OF
THE UNIVERSITY OF UNIVERSITY OF
COLORADO BOULDER, TO START A
COMPANY TO MAKE VIRUS
MEASUREMENTS FASTER AND MORE
ACCURATE.
AND NOT ONLY HAS THAT PROJECT
BEEN SUCCESSFUL, BUT INDEVR IS A
WOMAN-OWNED COMPANY AND ITS
LEADERSHIP, INCIDENTALLY, IS
ALSO ALL WOMEN.
THIS IS REALLY IMPORTANT TO US
BECAUSE THE SMALL BUSINESS
PROGRAM ACTUALLY HAS A
CONGRESSIONAL MANDATE TO
INCREASE THE NUMBER OF WOMEN
OWNED SMALL BUSINESSES, AND OVER
THE LAST FEW DECADES, IT'S
REALLY BEEN A CHALLENGE, WE'VE
BEEN STUCK AT AROUND 10 TO 15%
OF THE NUMBER OF SMALL
BUSINESSES WE FUND THAT ARE
WOMEN-OWNED, AND ALTHOUGH THAT
NUMBER CLOSELY TRACKS THE NUMBER
OF WOMEN-OWNED SMALL BUSINESSES
IN THE BUSINESS ENVIRONMENT IN
THE LIFE SCIENCE ENVIRONMENT, WE
ARE COMMITTED TO DOING BETTER
THAN THAT.
SO A NUMBER OF OUR PROGRAMS IN
COLLABORATION NOT JUST WITH THE
OFFICE OF RESEARCH OF WOMEN'S
HEALTH BUT WITH THE NIH
INITIATIVE ARE GEARED TO
INCREASING THE NUMBER OF
WOMEN-OWNED SMALL BUSINESSES AND
WOMEN ENTREPRENEURS THAT WE
FUND.
SO THAT'S A BRIEF OVERVIEW OF
THE SEED OFFICE AND HOW WE CAN
HELP MEET THE GOALS OF
INCREASING WOMEN'S HEALTH
RESEARCH.
I'D ENCOURAGE YOU TO CHECK OUT
OUR WEBSITE.
YOU CAN GET ON OUR LISTSERV.
WE HAVE AN NIH ENTREPRENEURSHIP
NEWS WHICH IS A NEWSLETTER THAT
COMES OUT ABOUT EVERY TWO WEEKS.
AND I'M JUST SO EXCITING TO BE
WORKING IN PARTNERSHIP WITH THE
OFFICE OF RESEARCH ON WOMEN'S
HEALTH, AND I WOULD BE HAPPY TO
HELP ANYBODY OUT WHO THINKS THEY
COULD BENEFIT FROM OUR SERVICES.
SO THANK YOU VERY MUCH.
[APPLAUSE]
>> THAT WAS AN INCREDIBLE
PRESENTATION AS WELL.
WE COULDN'T HAVE PLANNED IT ANY
BETTER FOR THE AREA OF SYNERGY.
THANK YOU SO MUCH.
THE FLOOR IS OPEN FOR QUESTIONS.
AND COMMENTS.
>> EXCELLENT TALK.
I THINK THE QUESTION I HAVE
WOULD BE RELEVANT TO YOU AND
POSSIBLY TO DR. TROMBERG AS
WELL.
SO WHAT ARE THE PROCESSES THAT
ARE SET IN PLACE, YOU KNOW, FOR
A PRODUCT DEVELOPMENT STAGE OR
VALIDATION WHERE INCORPORATION
OF INDIVIDUALS OF MINORITY ARE
EITHER REQUIRED AND/OR
ENCOURAGED, BECAUSE IN THE PAST,
THERE HAVE BEEN PRODUCTS THAT
HAVE BEEN DEVELOPED, DEVELOPED
THAT HAVE CATERED TO ONLY
INDIVIDUALS OF EUROPEAN
ANCESTRY, BUT ARE THERE
PROCESSES MORE SORT OF PROACTIVE
PROCESSES IN PLACE WHERE THAT
TYPE OF CONSIDERATION IS GETTING
DEVELOPED?
AND THEN ESPECIALLY FOR PRODUCTS
THAT INVOLVE A.I., MACHINE
LEARNING TECHNOLOGIES.
>> WELL, I CAN -- THERE ARE A
FEW TRAINING PROGRAMS THAT WE
HAVE.
THE MOST RECENT ONE WE'VE JUST
STARTED, WE RAN ONE COHORT
CALLED THE NIH CAPSTONE PROGRAM,
ENTREPRENEURSHIP CAPSTONE
PROGRAM, AND THAT WAS A PROGRAM
THAT WAS DEVELOPED AND RUN IN
COLLABORATION WITH THE EE JUST
LIFE SCIENCES COMMUNITY, AN
OFFSHOOT OF THE UNITED NEGRO
COLLEGE FUND, AND THAT PROGRAM
IS REALLY A KIND OF A COMBINED
MENTORING AND PRODUCT
DEVELOPMENT PROGRAM.
SO THAT IS REALLY FOCUSED ON
BRINGING PEOPLE FROM
UNDERREPRESENTED BACKGROUNDS
INTO THE PRODUCT DEVELOPMENT
SPACE.
I THINK YOUR QUESTION, THOUGH,
IS MORE ABOUT ADDRESSING THE
UNIQUE CHALLENGES OF BRINGING
PRODUCTS TO MARKET THAT ARE
ADDRESSING HEALTH DISPARITIES,
AND THAT, I THINK, IS A PROBLEM
THAT'S A LITTLE BIT HARDER TO GO
AFTER.
I THINK IT'S MULTIFACETED.
IT PARTLY DEALS WITH THE
APPETITE OF THE INVESTMENT
COMMUNITY, AND WE SEE THAT IN
OUR SPACE QUITE A BIT.
WE HAVE RELATIONSHIPS WITH A
NUMBER OF ORGANIZATIONS.
ONE OF THOSE ORGANIZATIONS IS
CALLED MED TECH COLOR, WHICH IS
A JOINT INDUSTRY AND PRIVATE
SECTOR AND GOVERNMENT
ORGANIZATION THAT'S LOOKING TO
INCREASE THE NUMBER OF BLACK AND
BROWN INNOVATORS IN THE MEDICAL
DEVICE SPACE.
THAT ORGANIZATION HAS BEEN VERY
ACTIVE IN ADDRESSING SOME OF
THESE CHALLENGES.
ALSO WOMEN IN BIO AND ALSO THE
ASSOCIATION FOR WOMEN IN
SCIENCE, AWIS, WE HAVE
RELATIONSHIPS WITH THESE
ORGANIZATIONS AND WE WORK
TOGETHER WITH THEM TO ADDRESS
SOME OF THOSE CHALLENGES.
>> MAYBE I COULD KIND OF ADD A
LITTLE BIT TO THAT OR BUILD ON
THESE POINTS FROM MATT.
IT'S A LITTLE BIT OF A CHICKEN
AND AN EGG PROBLEM.
SO FEM TECH, IT NOW KIND OF
COMMONLY ACCEPTED TO BE
SOMETHING, AN ENTITY THAT
MARKETS CAN BE DRIVEN TOWARDS
FEMTECH CAN BE SUCCESSFUL, BUT I
THINK MAYBE, I DON'T KNOW, MATT,
FIVE YEARS AGO, SIX YEARS AGO,
IT WAS ALMOST TRANSPARENT, AND
SO THAT'S A REALLY BIG DRIVER
THAT'S LIKE A BIG SHIP THAT'S
GENERATED INTEREST IN MARKETS.
SO THE EVOLUTION OF TECHNOLOGY,
YOU KNOW, EVERYBODY WANTS AN APP
TO BECOME THE NEXT GOOGLE, BUT
IT'S NOT NECESSARILY A BAD THING
TO CREATE SMALLER SCALE PRODUCTS
THAT HAVE SMALLER MARKETS THAT
ARE SUSTAINABLE IN REGIONS THAT
PERHAPS HAVEN'T HAD THAT
INNOVATION BEFORE.
AND THEN CREATE A NETWORK OF
SMALL SCALE INNOVATION IN
REGIONS WHERE IF THE PRODUCT
GOES UNDER, THE WHOLE TEAM TOANT
HAVE TO LEADOESN'T HAVE TO LEAVE
TO BOSTON OR THE BAY AREA.
SO THAT'S A BIG AREA OF GROWTH,
I THINK, IN PARTICULAR WITH
PRODUCTS THAT HAVEN'T GOTTEN THE
ATTENTION BECAUSE, YOU KNOW,
FROM A MARKET POINT OF VIEW,
IT'S A SMALLER NICHE.
SO I THINK THAT'S A BIG
STRATEGY, AND THAT'S RIGHT
BEHIND THE DEVELOPMENT OF MATT'S
PROGRAMS, WHERE THERE'S A
DISTRIBUTION OF CENTERS OF
EXCELLENCE ALL AROUND THE
COUNTRY AND IN KIND OF
UNDERPOPULATED REGIONS.
AND ANOTHER AREA WE MIGHT TALK
OFFLINE ABOUT THIS IS WITH A.I.
TODAY'S ANNOUNCEMENT OF THE
NOBEL PRIZE, LIKE, HOW DO WE
ENSURE THAT A.I. IS REALLY
WORKING FOR EVERYONE?
THOSE OF US IN THE ENGINEERING
COMMUNITY OBSESS OVER THIS.
AND I THINK WE'LL GO OFFLINE TO
TALK ABOUT IT, BUT I WOULD LIKE
PEOPLE TO BE AWARE OF MIDRC.ORG,
THE MEDICAL IMAGING DATA
RESOURCE CENTER THAT WE SUPPORT,
THAT HAS EXTENSIVE TOOLS TO
ADDRESS BIAS IN DATA, THE
DEVELOPMENT OF EXPLAINABLE AND
ETHICAL ALGORITHMS, THE
TRACEABILITY.
SO IT'S IN A WAY WHERE YOU CAN
ACTUALLY USE THOSE TOOLS IN YOUR
DATA, AND UNDERSTAND WHAT ARE
SOME OF THE KEY DRIVERS.
SO LIKE IT CAN BE VERY
TECHNICAL, BUT IT'S ALSO AT A
VERY HIGH LEVEL VERY
UNDERSTANDABLE, COMPARES YOUR
DATA TOOLS TO EVALUATE THE
ORIGIN OF YOUR DATA TO THE
POPULATION CENSUS, SO A LOT OF
GREAT TOOLS THERE, AND GREAT
QUESTIONS, YOU KNOW, THERE ARE
BIG CHALLENGES.
I CAN SAY THE ENGINEERING
COMMUNITY IS UP TO IT BUT MAYBE
THERE AREN'T ENOUGH OF US.
BECAUSE THEY'RE ALL GETTING
HIRED BECAUSE MATT IS CREATING
ALL THESE BUSINESSES.
>> I'M GOING TO GO TO IGHO AND
THEN STEVE.
>> THANK YOU SO MUCH.
THIS IS REALLY AMAZING,
FASCINATING, THE WORK THAT IS
BEING DONE IN THIS SPACE.
I JUST -- THE WORKFORCE
DEVELOPMENT, BECAUSE PEOPLE TEND
TO REALLY WORK ON THOSE THINGS
THAT ARE OF INTEREST TO THEIR
COMMUNITY.
I'M REALLY INTERESTED IN THE
SPECIFIC STEPS THAT HAVE BEEN
TAKEN BY NIBIB TO ATTRACT
DIVERSITY INTO THE PROGRAM,
BRING IN MORE WOMEN, BRING IN
MORE UNDERREPRESENTED MINORITY,
BECAUSE ONE WAY TO REALLY BRIDGE
THE GAP IS TO BRING PEOPLE WHO
ARE REALLY INTERESTED IN WORKING
IN THIS SPACE.
>> I CAN JUST ADDRESS THAT FROM
THE PERSPECTIVE OF THE REACH
PROGRAM, WHEN WE RELEASE THIS
NOTICE OF FUNDING OPPORTUNITY
THAT FUNDED THE MOST CURRENT SET
OF FIVE HUBS, WE CHANGE THAT
FUNDING OPPORTUNITY FROM THE
PREVIOUS ONE TO HAVE AN EMPHASIS
ON INCREASING DIVERSITY IN THE
REACH PROGRAM.
SO THAT WAS BROADLY DEFINED AS
GEOGRAPHICAL DIVERSITY, RACIAL
AND ETHNIC DIVERSITY, DIVERSITY
OF THE STAGE OF CAREER
DEVELOPMENT OF THE
INVESTIGATORS.
AND WE WORK THAT INTO THE NOTICE
OF FUNDING OPPORTUNITY AND I
THINK YOU CAN SEE THAT IN THE
NEW HUBS THAT WE FUNDED IN BOTH
THE PARTNER INSTITUTIONS AND
HOPEFULLY AS WE MOVE FORWARD IN
THE PROGRAM, THAT WILL BE
REFLECTED IN THE TECHNOLOGY
DEVELOPMENT PROJECTS THAT THEY
FUND.
EVERY ONE OF THESE HUBS HAS AN
EXTERNAL ADVISORY BOARD THAT IS
TRYING TO CREATE LIKE A LOCAL
ENVIRONMENT, A LOCAL PRODUCT
DEVELOPMENT ECOSYSTEM THAT
COMBINES THE INDUSTRY AND THE
ACADEMIC WORLD AND THEIR
REGIONAL LOCATION.
TO COMBINE PATIENT ADVOCACY AND
PATIENT REPRESENTATIVES.
THAT'S ANOTHER GREAT WAY TO
ENSURE THOSE NEEDS ARE BEING
ADDRESSED IN THOSE COMMUNITIES.
>> IF I CAN ADD A LITTLE BIT TO
THAT.
SO WE HAVE A NUMBER OF
DIVERSITY-FOCUSED FUNDING
OPPORTUNITIES LIKE A DIVERSITY
R01, DIVERSITY SUPPLEMENTS.
THESE ARE VERY ACTIVE AND VERY
SUCCESSFUL AND WELL SUBSCRIBED
PROGRAMS.
WE CREATED AN ENTIRE CENTER
WITHIN NIBIB, THE BIOMEDICAL
ENGINEERING AND TECHNOLOGY
ACCELERATION CENTER THAT
DR. PLATT IS LEADING AND HE CAN
SPEAK TO SEVERAL REALLY HIGHLY
IMPACTFUL PROGRAMS THAT HE'S
LAUNCHED WITHIN THE BETA CENTER
THAT ARE KIND OF BUILDING
BRIDGES TO THE INTRAMURAL
PROGRAM AND THE EXTRAMURAL
PROGRAM, BECAUSE THIS IS A --
IT'S A CHALLENGE ACROSS KIND OF
ALL SECTORS OF THE NIH.
SO WE HAVE A NUMBER OF
MECHANISMS.
A LOT OF ENTHUSIASTIC PEOPLE AND
GREAT LEADERSHIP, SO THOSE ARE
SOME CONCRETE APPROACHES AND I
CAN SHOW YOU A FEW MORE OF THESE
IF YOU'D LIKE TO SEE THEM.
OUR WEBSITE HAS A PRETTY GOOD
LISTING OF ALL THESE FUNDING
OPPORTUNITIES.
ONE SURPRISING THING, THE ENGS
PANICS OF WOMEN IN
BIOENGINEERING, NOBODY PLANNED
THAT.
YOU KNOW, THERE WASN'T LIKE AN
NIH SAYING -- THIS IS FEEDING
INTO I GUESS A NEED IN SOCIETY
THAT COMBINES KIND OF THE
ABILITY TO SORT OF INTEGRATE
YOUR PASSION FOR SCIENCE, MATH,
TECHNOLOGY, MEDICINE, BIOLOGY,
AND ALTRUISTIC GOOD.
SO THAT DIDN'T EXIST BEFORE
WITHIN SCHOOLS OF ENGINEERING.
SO IT'S A REALLY INTERESTING
CULTURAL PHENOMENON.
I'M A BIOENGINEER, NOT A SOCIAL
SCIENTIST, BUT YOU KNOW, IT'S
JUST FASCINATING, AND THOSE 6100
OR OVER 6,000 WOMEN GRADS IN
2022, THEY HAVE TO GET HIRED.
AND I THINK A LOT OF THEM ARE
GOING BOTH INTO INDUSTRY AND
STARTING THEIR OWN INNOVATION
AND ENTREPRENEURIAL CAREER
JOURNEYS.
>> THANK YOU.
AS YOU CAN TELL, EVEN THOUGH I
AM THE TIME MASTER, I COULDN'T
HELP MYSELF, I COULDN'T STOP YOU
ALL.
SO FIRST OF ALL, JUST THANK YOU
FOR REALLY NOT ONLY THE GREAT
PRESENTATIONS BUT REALLY THE
GREAT DISCUSSIONS.
I THINK THAT WHAT AN EXCITING
TIME FOR WOMEN'S HEALTH
RESEARCH.
SO THANK YOU FOR REALLY SPURRING
THAT DISCUSSION ON.
ALSO, I WANTED TO -- WE'RE GOING
TO DO A PICTURE AND I WANT TO
GIVE YOU SOME TIME TO AT LEAST
GET SOME FOOD AND COME BACK.
SO I'M GOING TO SLIP THE AGENDA
BY 15 MINUTES.
SO AT LEAST YOU CAN GET SOME
FOOD AND SOME NUTRITION AND
HYDRATION.
AND PLEASE FEEL FREE TO COME
BACK AND EAT WHILE WE'RE DOING
THE NEXT PRESENTATIONS.
BECAUSE I DID PROMISE YOU AND I
KNOW SOME OF YOU MAY ACTUALLY
HAVE YOUR TRAVEL ARRANGEMENTS
BASED ON OUR STOP TIME AT 4:10.
SO I'M GOING TO EAT INTO HER
TIME INSTEAD, AND SHE WILL SORT
OF FOCUS IT.
AND OF COURSE THESE ARE GOING TO
BE CONTINUE CONVERSATIONS.
SO IF WE COULD HAVE THE MEMBERS
GO TO THE FRONT OF THE ROOM FOR
THE PICTURE, AND THE BACK OF THE
ROOM, GO FIND SOME FOOD, AND
WE'LL SEE YOU AT 12:45.
>> HERE WE GO.
FIRST OF ALL, THANK YOU FOR YOUR
TIME AND WELCOME BACK.
I'D NOW LIKE TO CALL THE MEETING
TO ORDER AND INVITE DR. MANU
PLATT TO THE PODIUM, WHO WILL
MODERATE A PANEL ON TECHNOLOGY,
ENGINEERING AND INNOVATION IN
WOMEN'S HEALTH RESEARCH.
SO LET ME TALK ABOUT DR. PLATT
IN FRONT OF HIM.
DR. PLATT IS DIRECTOR OF THE
BETA CENTER AND ASSOCIATE
DIRECTOR OF SCIENTIFIC
DIVERSITY, EQUITY AND INCLUSION
FOR THE NATIONAL INSTITUTE OF
BIOMEDICAL IMAGING AND
BIOENGINEERING.
DR. MANU PLATT RECEIVED HIS B.S.
IN BIOLOGY FROM MOREHOUSE
COLLEGE AND PH.D. IN BIOMEDICAL
ENGINEERING.
AFTER A POSTDOC AT MASSACHUSETTS
INSTITUTE OF TECHNOLOGY, HE
RETURNED TO THE GEORGIA TECH
EMORY DEPARTMENT OF BIOMEDICAL
ENGINEERING, WHERE HE ADVANCED
TO FULL PROFESSOR.
HIS RESEARCH PROGRAM FOCUSES ON
PROTEOLYTIC MECHANISMS OF
DISEASE, TRANSLATIONAL
APPROACHES TO REDUCE STROKES IN
PEOPLE AFFECTED BY SICKLE CELL
DISEASE, AND HARNESSING NETWORKS
AND SYSTEMS BIOLOGY TOOLS TO
PREDICT DISEASE PROGRESSION.
HE'S ALSO INTEGRATED WITH
RESEARCH -- INTEGRATED WITH HIS
RESEARCH IMPORTANTLY ARE
MENTORING GOALS, CHANGING THE
LOOK OF THE NEXT GENERATION OF
SCIENTISTS AND ENGINEERS THROUGH
SUCCESSFUL DIVERSITY PROGRAMS
HE'S INITIATED.
IN 2003, DR. PLATT BECAME THE
INAUGURAL DIRECTOR OF THE BETA
CENTER THAT I JUST MENTIONED
THAT HE'S ALSO A FELLOW OF THE
AIMBE AND THE MBMES, THERE WE
GO, AND RECEIVED THE ROUTE 100
IN 2019 AND AAAS MENTOR AWARD IN
2021.
WELCOME, DR. PLATT.
>> THANK YOU VERY MUCH.
THANK YOU I'M REALLY EXCITED TO
BE HERE TO MODERATE THIS SESSION
ESPECIALLY COMING AFTER SOME
GREAT BIOMEDICAL ENGINEERING
DISCUSSIONS.
I'M PLEASED TO INTRODUCE OUR
PANELISTS, DR. KIM, DR. OYEN AND
MS. TARIYAL.
DR. KIM RECEIVED A BS IN
MICROBIOLOGY FROM THE UNIVERSITY
OF TORONTO AND A PH.D. IN QUEBEC
CITY.
SHE COMPLETED POSTDOCTORAL
TRAINING AT THE UNIVERSITY OF
ILLINOIS AT CHICAGO AND
ESTABLISHED AN INDEPENDENT
RESEARCH LABORATORY AT
NORTHWESTERN UNIVERSITY.
HER LABORATORY IS FOCUSED ON
UNDERSTANDING THE PLEIOTROPIC
INTERACTION OF HORMONES --
INCLUDING ENDOMETRIAL CANCER,
UTERINE FIBROIDS AND
ENDOMETRIOSIS.
THE LAB DEVELOPS APPROPRIATE IN
VITRO AND IN VIVO MODELS THAT
BEST REPRESENT THE PHYSIOLOGY OF
REPRODUCTIVE TISSUES.
INCLUDING 3D ORGAN CULTURES ON
MICRO FLEW TICK PLATFORMS,
PATIENT DERIVED XENOGRAFTED
TUMORS, PLEUR OWE POTENT STEM
CELLS OR IPSCs FOR DISEASE
MODELING.
THE ULTIMATE GOAL IS TO PROVIDE
POTENTIAL NEW DRUG TARGETS AS
WELL AS BETTER DRUG SCREENING
APPROACHES FOR THESE UTERINE
DISEASES.
DR. KIM IS A MEMBER OF THE
ROBERT LU RI. E COMPREHENSIVE
CANCER CENTER AND IS INVOLVED IN
EDUCATION PROGRAMS OF
NORTHWESTERN UNIVERSITY GRADUATE
SCHOOL.
OUR SECOND SPEAKER IS DR. OYEN,
WAYNE STATE UNIVERSITY IN
DETROIT, MICHIGAN.
SHE HAS A BACKGROUND IN
MATERIALS SCIENCE, MECHANICAL
ENGINEERING AND MEDICAL PHYSICS,
AND SHE HAS RESEARCHED AND
ADVOCATED FOR ENGINEERING
METHODOLOGIES WITHIN MATERNAL
HEALTH AND WOMEN'S HEALTH FOR
MORE THAN 2 25 YEARS TO IMPROVE
MATERNAL FETAL OUTCOMES
INCLUDING PREVENTION,
DIAGNOSTICS, AND INTERVENTIONS
RELEVANT TO PRETERM BIRTH.
CURRENT RESEARCH PROJECTS FOCUS
ON MULTI-SCALE CHARACTERIZATION,
PLACENTA FUNCTION, BIOMIMETIC
MATERIALS OF THE UTERUS AND
DIGITAL REPRESENTATIONS OF
PREGNANCY.
SHE ALSO HAS THE ADDED BONUS OF
MAKING ME THINK ABOUT THE
PLACENTA AND VASCULAR FLOW.
OUR FINAL PANELIST AND SPEAKER
IS MS. TARIYAL, THE CHIEF
EXECUTIVE OFFICER AND CO-FOUNDER
OF NEXGEN JANE.
SHE RECEIVED HER B.S. DEGREE
FROM GEORGIA TECH, SHOUT OUT.
AT NEXGEN JANE, SHE'S DRIVEN THE
DEVELOPMENT OF A NOVEL DATA
PLATFORM CHARACTERIZING UTERINE
BIOLOGY AT A MOLECULAR LEVEL.
IN THIS EFFORT SHE HAS RAISED
CAPITAL, ESTABLISHED AN I.P.
POSITION AND DEVELOPED A TEAM TO
CREATE BOTH MO VEL HARDWARE AND
SOFTWARE TO CHANGE HOW WOMEN
ACCESS CARE.
BEFORE THAT, SHE WORKED AT THE
BROAD INSTITUTE AND AT
BRISTOL-MYERS KIB.
SOSQUIBB.I'D LIKE TO CALL DR. KE
PODIUM AND WE DO ASK THAT ALL
AUDIENCE PARTICIPANT QUESTIONS
UNTIL WE GET TO THE PANEL AFTER
THE TALKS.
THANK YOU VERY MUCH.
>> NIRS OF
>> FULL DISCLOSURE, I'M NOT AN
ENGINEER, I'M GOING TO TELL YOU
HOW WE INCORPORATE SOME
ENGINEERING TECHNOLOGIES INTO
OUR WORK.
SO AS MANU DESCRIBED, QUICKLY I
JUST WANTED TO INTRODUCE MYSELF.
THE RESEARCH THAT WE DO IN THE
LAB, WE ARE VERY INTERESTED IN
UNDERSTANDING ENDOMETRIOSIS,
ENDOMETRIAL CANCER, UTERINE
FIBROIDS, HOW THEY DEVELOP, HOW
THEY GROW SO THAT WE CAN FIND
NOVEL TARGETS, ULTIMATELY FOR
THERAPY.
AND WE ARE LOOKING AT IT IN THE
LENS OF WHAT DRIVES DISEASES,
WHAT ARE THE MASTER REGULATORS.
WE LOOK AT SEX HORMONES, THEN WE
LOOK AT RISK FACTORS FOR EACH OF
THE DISEASES SUCH AS OBESITY,
GENETICS, RACE, ET CETERA.
WE'RE ALSO VERY INTERESTED IN
MODELING THE DISEASES
APPROPRIATELY IN THE LAB WHICH
I'LL GET INTO.
SO I WANT TO START OFF BY SAYING
THAT MEDICINE IS FAILING WOMEN'S
HEALTH AT THE CURRENT TIME.
WE STILL SUFFER FROM A LOT OF
THE DISEASES AND CONDITIONS.
THERE ARE NO EFFECTIVE MEDICINES
OR TREATMENTS FOR THEM, EVEN
THOUGH THEY'VE BEEN AROUND SINCE
THE BEGINNING OF WOMEN.
AND SO I FEEL THAT WE NEED TO
UNDERSTAND THE BIOLOGY AND THE
SCIENCE BETTER, AND IN ORDER FOR
US TO DO THAT IN 2024, IS TO USE
THE TECHNOLOGIES THAT ARE BEING
USED IN OTHER FIELDS AND REALLY
HONE THEM IN ON WOMEN'S HEALTH.
AND SO CONVENTIONALLY, WHEN
WE'RE TRYING TO MIMIC WOMEN'S
HEALTH IN THE LAB, WE USE CELL
CULTURE TECHNIQUES, WE TAKE
CELLS OUT OF THE WOMEN'S BODY
AND THEN STUDY THEM IN THE LAB,
BUT THERE'S A PROBLEM WITH THAT.
WHEN WE'RE TALKING ABOUT WOMEN'S
HEALTH, WE CAN'T JUST STUDY ONE
CELL TYPE AT A TIME IN A MONO
LAYER, BECAUSE BODIES ARE MADE
UP OF CELLS THAT LIVE TOGETHER
AND WORK TOGETHER IN ORDER TO
FUNCTION.
SO SO FAR, CONVENTIONALLY WE'VE
BEEN USING ONE CELL TYPE MONO
LAYERS IN PLASTIC, WE HAVE
EVOLVED TO ORGANOIDS NOW,
THREE-DIMENSIONAL STRUCTURES
THAT MIMIC THE ARCHITECTURAL AS
WELL AS THE FUNCTION OF THE
ORGAN.
BUT ULTIMATELY AT THE END OF THE
DAY, WHAT WE WANT IS AN
INTERACTION BETWEEN MULTIPLE
CELL TYPES IN THE BODY.
AND SO I CAN SAY THIS ABOUT
REPRODUCTIVE BIOLOGY IN GENERAL,
BUT IN ORDER FOR US TO
UNDERSTAND THE BIOLOGY, THERE
ARE VARIOUS MODEL SYSTEMS THAT
WE HAVE USED IN THE PAST, AND IN
ORDER TO UNDERSTAND THE DISEASES
OF, FOR EXAMPLE, THE
ENDOMETRIUM, WE NEED TO
UNDERSTAND NORMAL PHYSIOLOGY AS
WELL.
SO THIS IS JUST AN EXAMPLE OF MY
JOURNEY OF USING THE COW UTERUS
AS A MODEL DURING MY PH.D.
I EVOLVED TO PRIMATE UTERUS
DURING MY POSTDOC AND NOW
EXCLUSIVELY I STUDY HUMANS.
AND SO WE KNOW THATTER SINGLE
MODEL SYSTEM IS VALUABLE IN THE
CONTEXT THAT THEY'RE USED IN.
BUT NOT EVERY MODEL OR ANY MODEL
IS THE PERFECT MODEL FOR THE
WOMEN, WOMEN'S CONDITION.
SO IT'S VERY IMPORTANT TO
INTERPRET THE DATA THAT IS
COMING OUT OF OUR MODEL SYSTEMS
IN THE APPROPRIATE MANNER.
SO IN VIVO MODELS ALL THE WAY
FROM WORMS TO PRIMATES TO WOMEN,
THEN IN VITRO LIKE I WAS
MENTIONING, CELL CULTURE TISSUES
IN 2D, IN 3D, INTERACTIONS
BETWEEN TWO CELL TYPES, AND I
WILL TALK TO YOU A LITTLE BIT
ABOUT THE MULTI-TISSUE
INTERACTIONS THAT WE CAN NOW
STUDY.
WHY IS MODELING THE FEMALE
REPRODUCTIVE SYSTEM SO IMPORTANT
AND SO DIFFICULT?
WELL, THERE ARE LIMITATIONS OF
THE KINDS OF RESEARCH THAT WE
CAN DO IN WOMEN, ESPECIALLY IN
WOMEN THAT ARE OF FERTILE AGE
AND PREGNANT.
SO THERE ARE ETHICAL CONCERNS.
SPECIES DIFFERENCES DO EXIST AND
HORMONES ARE COMPLICATED.
ESTROGEN AND PROGESTERONE AND
TESTOSTERONE, THEY DO COMPLICATE
THE DATA.
SEX DIFFERENCES WE KIND OF
MENTIONED THAT EARLIER ON, THERE
ARE SEX DIFFERENCES IN DRUG
RESPONSES, SO 8 OUT OF THE 10
DRUGS THAT ARE PULLED FROM THE
MARKET BECAUSE OF BAD SIDE
EFFECTS IN WOMEN.
SO PRE-CLINICAL AND CLINICAL
RESEARCH MUST HAVE BOTH MALE AND
FEMALES, AND IN THE PAST IT HAS
MORE SO IN MALES, WHICH IS WHY
WE DON'T HAVE THE DATA.
SO HERE'S SOME CHALLENGES OF
STUDYING REPRODUCTIVE DISEASES.
AS WE MENTIONED, THE HUMAN
REPRODUCTIVE TRACT IS UNIQUE.
THERE ARE NO GREAT PHYSIOLOGICAL
MODELS THAT DEPICT THE HUMAN
CONDITION.
HORMONES ARE COMPLEX.
THE CURRENT IN VITRO MODELS ARE
SIMPLE.
AND WHEN WE DO TAKE TISSUES FROM
WOMEN, THE AMOUNT OF TISSUES WE
GET IS VERY, VERY SMALL.
SO I WANT TO INTRODUCE YOU TO
TISSUE CHIPS.
THIS ALL STARTED ABOUT 10 YEARS
AGO.
IT WAS A COLLABORATION BETWEEN
DARPA AND NCATS, WHERE
ULTIMATELY AT THE END OF THE
DAY, THE GOAL WAS TO MAKE A
HUMAN ON A CHIP SO THAT THE DRUG
SCREENING PROCESS WOULD BE MORE
EFFECTIVE IN BETWEEN
PRE-CLINICAL MOUSE MODELS TO
CLINICAL TRIALS.
THIS WAS OPEN TO ALL FIELDS AND
WE INSISTED THAT WE NEEDED A
FEMALE REPRODUCTIVE TRACT
REPRESENTED IN THIS TISSUE CHIP.
SO THIS IS WHAT WE DID.
DR. TERESA WOODRUFF IS THE ONE
THAT REALLY SPEARHEADED THIS
MISSION.
WE COLLABORATED WITH THE VERY,
VERY SMART ENGINEERS AT DRAPER
LABS WHO MADE A MICRO FLUIDIC
PLATFORM.
, WHICH IS VERY SIMILAR TO A
TISSUE CULTURE PLATE SO THE FORM
FACTOR IS VERY FAMILIAR.
AND IN THIS FLUIDIC PLATFORM,
WHAT YOU SEE ARE LITTLE CHAMBERS
THAT ARE ULTIMATELY CONNECTED
WITH CHANNELS WHERE THE FLUID
CAN BE SHARED BETWEEN EACH OF
THE MOLECULES THAT YOU PUT IN.
SO OUR GOAL WAS TO CREATE AN
OVARY, AN ENDOMETRIUM MIMIC, THE
FALLOPIAN TUBE, AND THE
ECTOCERVIX AND PLACE IT INTO
THIS EVATAR SYSTEM WE CALLED IT,
SO THEY COULD ALL TALK TO EACH
OTHER.
THE REALLY, REALLY NEAT THING
THAT TERESA WOODRUFF DID WAS
THAT SHE WAS ABLE TO TAKE MOUSE
OVARIES, ADD IN GONADOTROPES TO
MIMIC THE HUMAN MENSTRUAL CYCLE,
WHEREAS A MOUSE ESTRUS CYCLE IS
FOUR DAYS, SHE WAS ABLE TO MAKE
THIS OVARY BEHAVE LIKE A HUMAN
OVARY IN THE SENSE THAT OVER THE
COURSE OF 28 DAYS, THAT OVARY
MADE ESTROGEN AND PROGESTERONE
SIMILAR TO THE HUMAN OVARY.
AND WITH THAT, THIS IS JUST A
PICTURE OF WHAT WE OBSERVED, IF
YOU CAN SEE RIGHT HERE, YOU CAN
SEE FOLLICLES OFF LATING OVULA8
DAYS.
OVULATING FOLLICLES.
SO TO SUMMARIZE WHAT WE
DISCOVERED BY DOING THIS, FIRST
OF ALL, IT WAS POSSIBLE.
SECOND, ALL OF THE DIFFERENT
TISSUES THAT WERE REPRESENTED IN
THIS MICRO FLUIDIC SYSTEM, THEY
WERE FAMILIAR WITH EACH OTHER
AND THE SECRETED PRODUCTS OF THE
CULTURES AND SO THEY DID BETTER
AND THEY RESPONDED TO HORMONES
BETTER.
SO THE OTHER THING WAS BECAUSE
MEDIA IS CONTINUALLY FED IN AND
TAKEN OUT, TISSUES WERE ABLE TO
LAST LONGER AND MORE VIABLE.
HERE AGAIN, YOU SEE THE HORMONE
PATTERN SIMILAR TO A HUMAN
HORMONE SECRETION PATTERN.
SO WE LEARNED A LOT BY USING
THIS METHOD IN TERMS OF HAVING
TISSUES INTERACT WITH EACH
OTHER.
WE FOUND A LOT OF NEW BIOLOGY
WITH THIS AND WE FOUND THAT
ULTIMATELY AT THE END OF THE
DAY, TISSUES DO LIKE BEING WITH
EACH OTHER BECAUSE OF THE
SECRETED PRODUCTS THAT THEY SEE.
NOW, THIS WAS EVATAR, THIS WAS A
MICROFLUIDIC PLATFORM ENGINEERED
BY VERY, VERY SMART ENGINEERS IT
WAS VERY, VERY EXPENSIVE AND
VERY DIFFICULT TO USE BY
MOLECULAR BIOLOGISTS, SO THE
NEXT PHASE WAS TO BUILD
SOMETHING COMPARABLE THAT WAS
CHEAPER AND EASIER TO USE.
BASICALLY WE WANTED SOMEONE TO
TAKE IT OUT OF THE BOX, PLUG IT
IN AND USE IT.
SO THAT IS WHEN WE DEVELOPED
LATTICE, WORKING WITH A DEVICE
COMPANY.
AND WHAT IT IS IS, IT'S VERY
SIMILAR TO EVATAR WHERE IT A
FAMILIAR PLATE THAT HAS
MULTI-WELLS, HERE WE HAVE EIGHT
WELLS.
CAN YOU PUT WH.EACH OF THESE WEE
CONNECTED TO THROUGH CHANNELS
WHERE THE MEDIA IS PROPELLED
THROUGH, AND SO THEY'RE SEEING
EACH OTHER'S SECRETED PRODUCTS.
AND YOU CAN -- WE CAN
ORCHESTRATE WHERE THE FLOW GOES
BY A COMPUTER.
IT'S VERY CUSTOMIZED.
SO WE CAN STUDY THE INTERACTIONS
BETWEEN TWO DIFFERENT OR THREE
OR FOUR, WHAT HAVE YOU.
SO THE TECHNOLOGY IS EXTREMELY
SIMPLE.
IT'S BASICALLY THIS VALVE SYSTEM
THAT BRINGS UP FLUID AND THEN
DEPOSITS TO THE NEXT WELL.
AND WE CAN DO THIS 40 MICRO
LITERS EVERY HOUR.
SO AGAIN, VERY SIMPLE SYSTEM,
AND PRETTY EASY TO USE.
NOW WE WANTED TO MODEL A
REPRODUCTIVE DISEASE THAT
REQUIRED MULTIORGANS SUCH AS
PCOS, POLYCYSTIC OVARIAN
SYNDROME IS A SYNDROME THAT
IMPACTS MANY WOMEN, BUT THERE
ARE MANY DIFFERENT ORGAN SYSTEMS
INVOLVED, AND IT'S STILL NOT
CLEAR WHAT CAUSES PCOS, WHETHER
IT IS A HYPERANDROGENIC OVARY,
LOTS OF TESTOSTERONE BEING
PRODUCED, OR IF IT'S PRODUCTION
OF A LOT OF INSULIN, THAT IS NOT
KNOWN YET.
SO WITH THIS KIND OF SYSTEM, YOU
CAN IMAGINE HOW YOU CAN
MANIPULATE WHAT TISSUES ARE
REPRESENTED, AND YOU CAN SEE
WHICH O ORGAN THAT IS
DYSFUNCTIONAL DRIVES THE
DISEASE.
SO FOR EXAMPLE, WE HAVE BEEN
ABLE TO MAKE A HYPERANDROGENIC
OVARY SIMILAR TO THE SYSTEM
WHERE WE INCREASE THE LEVEL OF
LH LIKE WE FIND IN WOMEN WITH
PCOS, AND THEN LEVELS OF
TESTOSTERONE INCREASE IN SUCH A
SYSTEM.
THEN WE SEE WHAT HAPPENS
DOWNSTREAM.
SO I'VE INTRODUCED TO YOU
MICROFLUIDICS OF THE FEMALE
REPRODUCTIVE TRACT, AND HERE WE
HAVE A NEW TOOL TO START IS
ASKING NEW QUESTIONS AND GETTING
NEW ANSWERS, AND THEN THIS IS A
VERY NICE PLATFORM WHERE WE CAN
ACTUALLY INCREASE THE
COMPLEXITY, BUT THEN CONTROL THE
PARAMETERS SO IT IS VERY
CONTROLLED AND NEW SCIENTIFIC
QUESTIONS CAN BE ASKED.
SO ONE OF THE THINGS THAT WE CAN
DO WITH THIS PLATFORM IS
ULTIMATELY DRUG TESTING.
IF WE HAD MULTIPLE DIFFERENT
CELL TYPES REPRESENTED, WE CAN
SEEK POTENTIAL SIDE EFFECTS OF
THE DRUGS BEING TESTED.
A COLLABORATIVE OF OURS AT
RUTGERS IS LOOKING AT PFAS AND
ENVIRONMENTAL TOXINS AND THE
IMPACT ON OVARIAN FOLLICLE
DEVELOPMENT AND MATURATION, AND
IT'S BEEN VERY, VERY SUCCESSFUL
AND HE'S ALSO DONE IT IN THE
LATTICE PLATFORM.
SO TRANSLATION TO HUMAN HEALTH,
IT IS OBVIOUS WHETHER WE STUDY
THE BASIC SCIENCES AND GET
INFORMATION FROM THAT, WE CAN
ULTIMATELY USE THAT TO FIND NEW
COMPOUNDS, FIND NEW TARGETS, ET
CETERA.
BUT IT'S ALSO IMPORTANT TO TEST
ALL OF THESE NEW DRUGS IN THE
CONTEXT OF SEX HORMONES.
WHANS WHEN THERE'SWHAT HAPPENS T
OF ESTROGEN, TESTOSTERONE, ET
CETERA.
THIS ALLOWS YOU TO ARE MORE
COMPLEX IN A PHYSIOLOGICAL
MANNER AND IT DOES MIMIC THE
HUMAN BODY BETTER FOR DRUG
TESTING.
SO I WAS ALSO ASKED WHAT
CHALLENGES WE FACE IN OUR
RESEARCH.
IN TERMS OF THE RESEARCH, WE
WORK WITH HUMAN TISSUES.
GETTING HUMAN TISSUES IS NOT
ALWAYS EASY.
WE GET THEM FROM THE O.R. WHEN
PATIENTS CONSENT TO DONATE THEIR
TISSUES THAT'S OTHERWISE GOING
TO BE DISCARDED.
SO SOMETIMES WE GET VERY LITTLE,
SOMETIMES WE DON'T GET ANY.
AND THEN TRYING TO SYNCHRONIZE
GETTING DIFFERENT HUMAN TISSUES,
DIFFERENT SURGERY SCHEDULES, IS
A CHALLENGE.
WE WOULD NEED SOME REALLY NICE
FREEZING PROTOCOLS SO WE CAN GET
ALL THE TISSUE TYPES WE WANT AND
PUT THEM TOGETHER IN THE
MICROFLUIDIC PLATFORM.
SCALABILITY IS ALSO A PROBLEM
RIGHT NOW BECAUSE OF THE TISSUE
AVAILABILITY, AND THEN REALTIME
MONITORING OF HEALTHY CULTURES,
WE CAN DO THIS BY EYE WITH A
MICROSCOPE BUT OTHER THAN THAT,
WE DO NEED BETTER BIOSENSORS, ET
CETERA.
WHAT HAVE BEEN THE CH CHALLENGEN
COMMERCIALIZATION?
WE DO WANT PEOPLE TO USE
LATTICE, AND I'VE EVEN GONE
THROUGH PITCH PRACTICES WITH
NORTHWESTERN FOLKS, AND ALWAYS
THE QUESTION THAT I'M ASKED IS,
WHAT MARKET ARE YOU TRYING TO
TARGET?
BECAUSE LATTICE IS A PLATFORM
AND IT'S AGNOSTIC.
WE CAN USE TO STUDY FEMALE
REPRODUCTIVE HEALTH OR WE CAN
USE TO STUDY BRAIN HEALTH OR I
EVEN PROPOSED A GRANT TO STUDY
MENOPAUSE IN DIFFERENT TISSUE
TYPES THAT ARE INVOLVED IN
MENOPAUSE.
SO THAT IS A QUESTION I'M ALWAYS
FACED, WHAT MARKET ARE YOU
TRYING TO TARGET.
ALSO USABILITY, IT HAS TO BE
SIMPLE, IT CANNOT BREAK DOWN, IT
HAS TO BE CHEAP ENOUGH, AND THEN
FINDING THE COMMERCIAL PARTNERS
AS WELL AND THEN FUNDERS.
SO I WAS VERY GLAD TO HEAR THE
TWO PREVIOUS SPEAKERS ABOUT SEED
AND SBIR, ET CETERA.
SO THIS IS A GREAT BIG MARKET
THAT WE STILL HAVE TO PLUG INTO.
MENOPAUSE IS A HUGE MARKET,
$17 BILLION, AND YOU CAN SEE ALL
THE NUMBERS.
THERE IS THE NEED, ESPECIALLY IN
WOMEN'S HEALTH AND DISEASES,
THERE NEEDS TO BE BETTER DRUGS,
BETTER TREATMENT, SURGERY CANNOT
BE THE ONLY OPTION.
AND I SEE YOU STANDING UP.
I'M DONE.
THANK YOU.
THIS TAKES A VILLAGE.
THANK YOU TO MY PREVIOUS MEMBERS
AS WELL AS MY CURRENT MEMBER OF
MY LAB, OTHER COLLABORATORS
INCLUDING TERESA WOODRUFF,
MARGRIT URBANEK, CHRISTINA
BOOTS, OTHER COLLABORATORS AS
WELL AT DRAPER LABS AND OF
COURSE ALL THE FUNDING AGENCIES.
THANK YOU.
[APPLAUSE]
>> OKAY, SO FORTUNATELY I KNEW
JULIE WAS GOING TO TALK BEFORE
ME SO I'M GOING TO PURPOSEFULLY
SCWIP OVER TALKING MUCH ABOUT
MICRO FLUIDICS AND FOCUS A
LITTLE BIT MORE ON DIGITAL TWINS
AND COMPUTATIONAL MODELS FOR
STUDYING PREGNANCY.
SO I'D LIKE TO INTRODUCE A
LITTLE BIT OF MY BACKGROUND
BECAUSE IT'S KIND OF A WEIRD
THING TO SAY WHERE AN ENGINEER
GOT INTO BEING A PREGNANCY
RESEARCHER.
I STARTED OUT IN ORTHOPEDIC
SCIENCE, SO I STARTED OUT IN
ARTHRITIS RESEARCH, I DID A LOT
LOT WITH BONE AND CARTILAGE.
THAT'S A FIELD WHERE ENGINEERING
HAS HAD A FOOTHOLD FOR MORE THAN
50 YEARS.
SO IF YOU GO AND LOOK AT THE
ROSTER OF MOST ORTHOPEDICS
DEPARTMENTS, CLINICAL
DEPARTMENTS IN THE UNITED
STATES, YOU WILL FIND
ENGINEERING PROFESSORS WITHIN
THEIR FACULTY BECAUSE THERE IS
AN ACKNOWLEDGMENT THAT
MECHANICAL LOADING IS IMPORTANT
IN ORTHOPEDIC INJURIES AND OR
THE PEE ORTHOPEDIC REPAIRS.
MY GOAL IS TO MAKE THAT HAPPEN
IN OB-GYN BECAUSE THERE ARE
PROBLEMS HERE THAT ALSO HAVE
MECHANICAL COMPONENTS.
AND IN FACT, THAT'S WHAT
HAPPENED TO ME.
I WAS A GRADUATE STUDENT WORKING
IN THE LAB ON A CARTILAGE
PROJECT, AND I TOOK A COLD CALL
FROM AN OBSTETRICIAN WHO WAS
INTERESTED IN PREMATURE RUPTURE
OF THE FETAL MEMBRANES IN
PRETERM BIRTH.
AND HE SAID, I THINK THIS IS A
MECHANICAL PROBLEM.
DO YOU HAVE AN ABILITY TO
MEASURE FORCES?
AND I SAID YES, YES, I DO.
AND SO BY THE TIME I FINISHED MY
PH.D., I WAS ACTUALLY WORKING
FULL TIME IN OB-GYN IN A PROJECT
LOOKING AT PRETERM RUPTURE OF
FETAL MEMBRANES AND FIRI FINISHY
PH.D. ON THE SIDE.
SO THAT'S HOW I GOT HERE.
BUT ONCE I DISCOVERED THERE WERE
ALL THESE OPPORTUNITIES IN
WOMEN'S HEALTH THAT HAD
ENGINEERING COMPONENTS THAT HAD
NOT BEEN STUDIED, I ESSENTIALLY
STOPPED DOING ORTHOPEDICS
RESEARCH OVER TIME AND SPENT ALL
OF MY TIME NOW FOCUSED ON
PREGNANCY AND OTHER ASPECTS OF
WOMEN'S HEALTH.
SO FOR EXAMPLE, THIS IS A FIGURE
FROM A PAPER ABOUT PRETERM
BIRTH, PRETERM BIRTH IS ABOUT
10% OF ALL BIRTHS, SO AGAIN, A
HUGE PROBLEM.
AND WHAT I HAVE HIGHLIGHTED IN
RED HERE ARE THE DIFFERENT AREAS
OF PRETERM BIRTH THAT CLEARLY
HAVE A MECHANICAL COMPONENT.
SO YOU'VE GOT THINGS ON THE
MATERNAL SIDE, MATERNAL TRAUMA,
PREECLAMPSIA, AN ELEVATED
PRESSURE.
YOU HAVE THINGS ON THE FETAL
SIDE.
PLACENTAL SIDE, PLACENTAL
ABRUPTION WHEN YOU GET
DETACHMENT OF THE PLACENTA FROM
THE UTERUS, AND THEN THINGS TO
DO WITH BIRTH INCLUDING
PREMATURE RUPTURE AND CERVICAL
SHORTENING AND CERVICAL
DILATION.
SO AS THE PREVIOUS SPEAKER WAS
SAYING, THE TRADITIONAL ROUTE TO
GET THINGS APPROVED THROUGH THE
FDA WAS REALLY FOCUSED ON ANIMAL
RESEARCH, BUT ANIMAL RESEARCH IS
NOT ALWAYS GREAT.
MY PRIMARY AREA OF INTEREST
THESE DAYS IS THE PLACENTA AND
THERE ARE NO GOOD ANIMAL MODELS
FOR THE HUMAN PLACENTA.
STRUCTURALLY, IT IS DIFFERENT,
IT IS DIFFERENT PARTICULARLY ON
A MICROSCOPIC STRUCTURE, EVEN
THOUGH THE MOUSE PLACENTA AND
THE HUMAN PLACENTA ARE THE SAME
SHAPE.
THEY DON'T HAVE THE SAME TISSUE
LAYERS.
HUMAN PLACENTA IS MUCH MORE
INVASIVE.
BUT OF COURSE BEING SOMEONE
WHO'S INTERESTED IN
BIOMECHANICS, I ALSO LOOK AT
QUADRA PEDAL ANIMALS HAVING
LITTERS AND SEE THAT THE
MECHANICS OF PREGNANCY ARE VERY
DIFFERENT IN THAT CASE COMPARED
TO IN HUMANS.
SO I ALSO EXCLUSIVELY STUDY
HUMAN TISSUES.
AND THESE DAYS, WITH THE FDA
MODERNIZATION ACT THAT HAPPEN IN
A BIZARRE BIPARTISAN ACT OF
CONGRESS IN 2022, NON-CLINICAL
TESTS ARE NOW AN IMPORTANT PART
OF THE OVERALL MECHANISM TO
GETTING NEW DRUGS AND DEVICES
APPROVED.
AND THAT INCLUDES THINGS LIKE
MICROPHYSIOLOGICAL SYSTEMS AND
ORGANS ON CHIPS, BUT IT ALSO
INCLUDES COMPUTATIONAL MODELS.
AND SO I'M NOT GOING TO GO INTO
MUCH AS I SAID ABOUT
MICROPHYSIOLOGICAL SYSTEMS OR
TISSUE ENGINEERING, JUST TO SAY
THAT WE, TOO, HAVE DELVED IN
THIS AREA FOCUSED ON MATCHING
MECHANICAL PROPERTIES, BUT WE'RE
ALSO VERY INTERESTED IN USING
COMPUTATIONAL MODELS TO LOOK AT
PREGNANCY, AND ALSO INCREASINGLY
USING BIG DATA, LOOKING AT
MACHINE LEARNING, IMAGE
PROCESSING, TO DO WITH PREGNANCY
AND OTHER ASPECTS OF WOMEN'S
HEALTH.
SO I'M GOING TO FOCUS THE REST
OF MY PRESENTATION ON INSILICO
APPROACHES.
SO WHAT WE'RE DOING RIGHT NOW IS
REALLY FOCUSED ON TRYING TO MAKE
COMPUTATIONAL MODELS ENTER THE
TRADITIONAL CLINICAL PATHWAY FOR
LOOKING AT HUMAN PREGNANCY.
SO WHAT DID WE DO IN HUMAN
PREGNANCY ALL THE TIME?
WE DO ULTRASOUNDS.
SO WITH THOSE ULTRASOUNDS, WE
CAN GET A LOT OF CLINICAL DATA
THAT'S VERY RELEVANT THAT CAN BE
USED TO BUILD A COMPUTATIONAL
MODEL, AND THAT COMPUTATIONAL
MODEL CAN THEN BE USED FOR
CLINICAL DECISION-MAKING.
AND YOU CAN DO THIS AT A
MACROSCOPIC SCALE, IF YOU'RE
DOING RESEARCH LIKE WE ARE, YOU
CAN ALSO DO THIS AT A
MICROSCOPIC SCALE.
SO WE DO THIS WITH RESEARCH
IMAGES, JUST AS MUCH AS WE DO IT
WITH CLINICAL IMAGES.
THE RESEARCH IMAGES ARE THERE
FOR, AT A SMALLER SCALE, SO
THESE PICTURES ON THE TOP ROW
ARE LOOKING AT BLOOD FLOW AND
OXYGEN T DI FAWTION IN THE DIFFE
PLACENTA, WHEREAS THE BOTTOM IS
MACROSCOPIC BASED ON ULTRASOUND,
BUT THE WORKFLOW IS THE SAME IN
BOTH OF THESE CASES.
IT'S TAKING PICTURE OF
SOMETHING, USING TO BUILD
COMPUTATIONAL MODELS, AND THOSE
COMPUTATIONAL MODELS ARE
PATIENT-SPECIFIC AND WE'RE
TRYING TO MAKE THEM AS REALTIME
AS POSSIBLE.
SO THEY CAN BE USED FOR
DIAGNOSTIC PURPOSES.
SO AS I SAID, WE SPEND A LOT OF
TIME WORKING ON PLACENTAL
TRANSPORT.
WE'VE BEEN BUILDING DIGITAL
TWINS OF THE PLACENTA AND I LIKE
TO POINT OUT THAT A DIGITAL TWIN
IS A VERY SPECIFIC TYPE OF
COMPUTATIONAL MODEL.
THIS IS WHERE YOU CAN TAKE
INFORMATION FLOW GOING BACK AND
FORTH BETWEEN THE PATIENT AND
THE MODEL.
SO THIS IS PARTICULARLY
INTERESTING IN PREGNANCY, WHERE
YOU MATE DO REPEATED ULTRASOUNDS
ON A PERSON THROUGHOUT THE
PREGNANCY SUCH THAT YOU'RE
GETTING NEW INFORMATION THAT YOU
CAN FEEDBACK INTO THE MODEL, YOU
CAN RUN SCENARIOS AND THEN YOU
CAN USE THAT INFORMATION FROM
THOSE MODELING SCENARIOS TO
EFFECT PATIENT CARE.
SO I'M NOT GOING TO TALK ANY
MORE ABOUT THE PLACENTAL
TRANSPORT MODELS.
AIM GOINGI'M GOING TO FOCUS ON E
TRYING TO DO TO LOOK AT
C-SECTION SCARS.
SO C-SECTIONS ARE RISING ACROSS
THE WORLD, PARTICULARLY IN
DEVELOPED COUNTRIES, THEY'VE
BEEN VERY HIGH FOR A LONG TIME,
WELL OVER 30%, BUT THEY'RE GOING
UP IN DEVELOPING COUNTRIES AS
WELL.
SOME ANALYSIS HAS SHOWN THAT
ABOVE A C-SECTION RATE OF ABOUT
19%, YOU DO NOT GET ANY FURTHER
IMPROVEMENT IN MATERNAL
MORTALITY OR FETAL MORTALITY.
SO 19% LOOKS LIKE THIS.
THIS IS A MAP OF THE WORLD.
YELLOW IS 19%.
SO ANYWHERE THAT'S GREEN IS A
RATE OF C-SECTIONS BELOW 19%.
YOU COULD PROBABLY ARGUE THAT IN
MANY OF THOSE PLACES, THERE IS
AN OPPORTUNITY FOR DECREASING
MATERNAL MORTALITY BY DOING MORE
WITH C-SECTIONS, BUT IN OTHER
PLACES THAT ARE BRIGHT RED ON
THIS MAP, WHICH INDICATES OVER
50% OF BIRTHS ARE BY C-SECTION,
THOSE ARE NOT IMPROVING MATERNAL
HEALTH.
AND THE PROBLEM IS THAT WHEN YOU
DO A C-SECTION, YOU ARE LEFT
WITH A SCAR, AND WHEN YOU ARE
LEFT WITH A SCAR, THERE IS RISK
OF BAD THINGS HAPPENING
SUBSEQUENTLY, ESPECIALLY BUT NOT
ONLY IN A LATER PREGNANCY.
SO YOU CAN HAVE AN ECTOPIC
C-SECTION SCAR PREGNANCY WHERE
IT IMPLANTS IN THE SCAR AND IS A
NON-VIABLE PREGNANCY.
CAN YOU HAVE PLACENTA ACCRETA,
WHICH IS WHEN THE PLACENTA IS
TOO INVASIVE AND YOU SEE
PROBLEMS AND COULD HAVE A CASE
WHERE YOU NEED TO DO A
HYSTERECTOMY AT DELIVERY, AND
YOU CAN HAVE UTERINE RUPTURE
FROM THE SCAR.
AND PART OF THE PROBLEM WITH A
SCAR IS THAT YOU OFTEN SEE IN
THE PICTURE ON THE RIGHT THERE A
DEFECT, WHERE YOU DON'T HAVE
FULL THICKNESS HEALING, AND FROM
AN ENGINEERING PERSPECTIVE, THAT
LOOKS LIKE A STRESS
CONCENTRATION, AND SO AN
INCREASED RISK OF FUTURE
RUPTURE.
SO WHAT WE'VE BEEN DOING WITH
OUR COLLABORATORS UP AT
COLUMBIA, THEY HAVE BEEN TAKING
GEOMETRICAL INFORMATION ABOUT
UTERUSES IN PREGNANT WOMEN, AND
THEY HAVE MADE THIS ALL OPEN
SOURCE.
SO ANYONE WHO WANTS TO BUILD A
COMPUTATIONAL MODEL OF THE
UTERUS CAN DOWNLOAD THIS
BEAUTIFUL DATASET THAT HAS ALL
THESE JE MET CAL PARAMETERS
THROUGHOUT THE ENTIRE PREGNANCY.
WE THEN TAKE THOSE GEOMETRICAL
PARAMETERS, TURN THEM INTO A
3-DIMENSDIMENSIONAL MODEL AND RN
SIMULATIONS BASED ON THAT.
SO WE STARTED OUT THIS PROJECT
WITH JUST SORT OF A HISTORICAL
FACT THAT THERE WAS A TIME WHEN
A LOT OF C-SECTION SCARS WENT UP
AND DOWN INSTEAD OF TRANSVERSE,
AND THE RISK OF RUPTURE OF THE
UTERUS WAS ACTUALLY GREATER.
SO WE THOUGHT, WELL, WE SHOULD
BE ABLE TO SHOW THAT THE
STRESSES ARE HIGHER IN THAT CASE
CASE, AND SURE ENOUGH, WE RUN
THE SIMULATIONS AND WE GET THAT
SORT OF PROOF OF CONCEPT.
SO THAT ENCOURAGES US TO
CONTINUE LOOKING AT THIS, AND IN
FACT, WHAT WE THEN DID WAS
MEASURE SOME OF THESE DEFECTS
AND ACTUALLY MODEL THE DEA FECT.
DEFECT.THE GRAPH ON THE RIGHT IS
SHOWING THE STRESS GOING ACROSS
THE SCAR FROM THE EDGE TO THE
CENTER, AND SO THE BLACK LINE
THAT JUST KIND OF GOES DOWNWARDS
IS WITH NO DEFECT.
THE RED LINE IS WITH A DEFECT.
SO IF YOU HAVE A C-SECTION SCAR
DEFECT, YOU CAN ACTUALLY HAVE
ABOUT A FACTOR OF 2 GREATER
STRESSES IN THAT DEFECTED
REGION, WHICH MEANS THAT'S A
PERSON WHO'S AT GREATER RISK OF
NOT JUST A UTE L UTERINE RUPTURT
IT TURNS OUT POSSIBLY PRETERM
BIRTH AS WELL.
SO BY LOOKING AT THIS IN
INDIVIDUAL PATIENTS, WE CAN DO
SOMETHING THAT'S CLINICALLY
RELEVANT IN TERMS OF PREDICTING
LONG TERM RISK.
SO IN FACT, WHAT WE'RE DOING NOW
IS WE'RE WORKING WITH THE GROUP
AT UNIVERSITY COLLEGE LONDON, SO
I SPENT A GREAT DEAL OF MY
CAREER OVER IN THE UK AT
CAMBRIDGE, SO I HAVE A LOT OF
COLLABORATORS STILL OVER THERE.
THEY HAVE BEEN DOING AN ENTIRE
PROGRAM OF JUST MEASURING
C-SECTION SCARS AND SCAR
DEFECTS.
SO THEY HAVE BEEN COLLECTING A
LOT OF THIS ANATOMICAL DATA
ABOUT THE NATURE OF THESE SCARS,
AND ABOUT HOW THESE SCAR DEFECTS
ARE PRESENT IN SOME OF THEIR
PATIENTS, AND THEN THEY COLLECT
INFORMATION ON CLINICAL OUTCOMES
INCLUDING PRETERM BIRTH AND ANY
OTHER COMPLICATIONS THAT THEY
SEE IN THE PREGNANCY.
AND SO AT THE MOMENT, WHERE WE
ARE WITH THIS PROJECT, THIS IS
ONLY ABOUT A YEAR OLD PROJECT,
AND SO RIGHT NOW THEY'RE FEEDING
US ALL OF THE INFORMATION ABOUT
THESE C-SECTION SCARS SO IT
BASICALLY IN THE FORM OF A
RETROSPECTIVE STUDY WHERE WE CAN
THEN SAY TRY TO CLASSIFY THE
RISK IN THESE PATIENTS FOR WHICH
THEY HAVE THE CLINICAL DATA AND
CAN COMPARE THAT AGAINST WHAT
WE'VE BEEN GETTING.
SO WITH THE MEASUREMENTS THAT WE
HAVE, IN FACT, WE CAN TRACK HOW
THAT C-SECTION SCAR LOOKS
THROUGHOUT THE PREGNANCY,
BECAUSE THIS BASELINE DATASET
FROM OUR COLLABORATORS AT
COLUMBIA, YOU CAN SEE THESE
INDIVIDUAL PARAMETERS AS A
FUNCTION OF GESTATIONAL AGE.
FIRST OF ALL, THE STANDARD
DEVIATIONS ARE QUITE SMALL, SO A
UTERUS KIND OF IS THE SAME SIZE
AND SHAPE AS IT GETS BIGGER
DURING PREGNANCY ACROSS A LARGE
POPULATION OF PEOPLE, AND THESE
NUMBERS SEEM TO VARY RELATIVELY
SMOOTHLY SUCH THAT WE CAN
BASICALLY MAP OUT AN AVERAGE
SECOND TRIMESTER PLACENTA AT
THIS MANY WEEKS GESTATION VERSUS
LOOK AT A THIRD TRIMESTER ONE AT
THIS MANY WEEKS GESTATION,
KNOWING WHAT WE KNOW ABOUT THE
C-SECTION AND THE C-SECTION SCAR
AND SCAR DEA FECT.
DEFECT.
WE CAN PUT THOSE INTO OUR MODEL
FOR NIECE PATIENT-SPECIF THESE C
SIMULATIONS.
SO WE ARE VERY INTERESTED IN HOW
THIS KIND OF INTERDISCIPLINARY
LAB RANGE OF MCOLLABORATION COUT
OB-GYN BECAUSE THIS HAS BEEN BIG
IN OTHER FIELDS, AS I SAID, I
CAME FROM AN ORTHOPEDICS
BACKGROUND BUT THERE'S ALSO BEEN
A LONG HISTORY OF BIOENGINEERING
COLLABORATION IN CANCER
RESEARCH, IN CARDIOVASCULAR
RESEARCH, NEUROSCIENCE.
I COULD GO ON AND ON.
BUT OB-GYN HAS HISTORICALLY NOT
HAD THIS MUCH OF A COLLABORATION
WITH ENGINEERING AND WE BELIEVE
THERE ARE A LOT OF OPPORTUNITIES
HERE, BOTH IN VITRO AND IN
SILICO.
WE NEED TRAINING DATASETS FOR
MACHINE LEARNING.
SO MIDRC WAS MENTIONED EARLIER
BY THE NIBIB DIRECTOR.
THERE ARE NOT OBSTETRICAL OR
GYNECOLOGICAL ULTRASOUNDS IN
THAT DATASET.
THERE IS NO CLINICALLY AVAILABLE
OR ENGINEERING AVAILABLE DATASET
OF TRAINING IMAGES BECAUSE
OB-GYN ULTRASOUND IMAGING IS
DIVORCED FROM THE REST OF
RADIOLOGY.
IT'S DONE IN OB-GYN CLINICS.
SO THIS IS A RESOURCE THAT IN
ORDER TO GET WOMEN'S HEALTH UP
TO SPEED WITH THE REST OF
MEDICINE, WITH THE EXPANSION IN
A.I. AND MACHINE LEARNING, WE
NEED THESE SORTS OF OPEN SOURCE
TRAINING DATASET THAT ARE
AVAILABLE TO THE RESEARCH
COMMUNITY.
WE ALSO NEED A MECHANISM TO
HARNESS ETHICALLY THE BIG DATA
NATURAL EXPERIMENTS THAT ARE
HAPPENING IN WOMEN'S HEALTH.
MILLIONS OF WOMEN ARE PREGNANT
EVERY YEAR.
THERE'S A LOT OF DATA OUT THERE.
IF YOU'RE IN SCANDINAVIA, YOU
MIGHT HAVE ACCESS TO THE ENTIRE
COUNTRY'S DATABASE OF ELECTRONIC
HEALTH RECORDS.
WE DON'T HAVE ANYTHING LIKE THAT
HERE.
WE NEED TO FIGURE OUT HOW TO
COME UP WITH THAT SORT OF DATA,
SO WE CAN USE MACHINE LEARNING
AND BIOSTATISTICAL METHODS.
WE NEED GOOD HUMAN CELL SOURCES
AND CONSISTENT TISSUE SCAFFOLDS
FOR IN VITRO STUDIES.
I WON'T BELABOR THAT POINT SINCE
IT'S BEEN MADE ALREADY.
AND FINALLY, THE LAST POINT THAT
I WANT TO MAKE BEFORE I FINISH
IS THAT WE STILL NEED MORE
MECHANISTIC UNDERSTANDING.
IT SEEMS AS THOUGH THERE'S BUN A
LOT OF PUSH RECENTLY, INCLUDING
THE RADX PROGRAM, FOR GETTING
PATIENT-CENTERED DEVICES OUT
THERE AND DOING DIAGNOSTICS AND
END-STAGE THINGS, BUT WE DON'T
HAVE THE UNDERLYING
UNDERSTANDING OF MECHANISM IN A
LOT OF THESE CASES.
OTHERWISE THE PRETERM BIRTH RATE
WOULD HAVE BEEN STATIONARY AT
10% FOR SO MANY DECADES.
AND SO WE NEED TO BE ABLE TO USE
ENGINEERING METHODS AND OTHER
METHODS TO OH FOCUS OP GETTING
THE UNDERLYING UNDERSTANDING NOT
JUST THE NEW DEVICES TO TREAT
DISEASES OR TO DIAGNOSE DISEASES
THAT WE DON'T REALLY UNDERSTAND
WHAT THEY'RE DOING.
SO WITH THAT, I'LL THANK YOU
VERY MUCH.
JUST AS AN AMUSING POINT, I
SHOULD RUN OUT THAT I RUN AN
ALMOST ENTIRELY FEMALE-RUN
ENGINEERING GROUP.
WOMEN FLOCK TO THIS SORT OF
RESEARCH, AND I TAUGHT THE
FIRST-EVER COURSE THIS PAST
SPRING ON ENGINEERING IN WOMEN'S
HEALTH COVERING REPRODUCTIVE AND
NON-REPRODUCTIVE DISEASES AND
HAD ALMOST 50 ENGINEERING
STUDENTS, ALMOST ALL FEMALE.
SO WITH THAT, I WILL STOP AND
HAND IT OVER.
THANK YOU.
[APPLAUSE]
>> THANK YOU SO MUCH FOR THE
OPPORTUNITY TO SPEAK TO ALL OF
YOU.
I LOVE GOING AFTER JULIAN
MICHELLE BECAUSE IT GIVES ME A
LOT OF HOPE.
IT GETS ME EXCITED ABOUT
RESEARCH HAPPENING IN WOMEN'S
HEALTH AND THAT'S NECESSARY
BECAUSE WHEN WE STARTED TOWN
THIS PATH OF LOOKING AT
MENSTRUATION AS A NOVEL SAMPLE
TYPE FOR MOLECULAR PROFILING IN
2013, THE LANDSCAPE WAS VERY
DIFFERENT.
I WILL TELL YOU THAT I WENT TO
MEETINGS WHERE MALE INVESTORS
WOULD NOT MAKE EYE CONTACT WITH
ME AND THEY WOULD ACTUALLY LOOK
TO MY MALE CO-FOUNDER TO TALK
ABOUT THE LIVED EXPERIENCE OF
MENSTRUATION, WHICH I THOUGHT
WAS VERY AMUSING.
BECAUSE HE WAS ILL-EQUIPPED TO
ANSWER THOSE QUESTIONS.
AS WELL AS THEY WOULDN'T SAY THE
WORD MENSTRUATION, THEY ACTUALLY
USED EUPHEMISMS SUCH AS "THAT
TIME OF A MONTH" THAT A WOMAN
DOES WHATEVER IT IS THAT SHE
DOES, WHICH MADE ME QUESTION IF
THEY ACTUALLY KNEW WHAT A WOMAN
DOES AT THAT TIME OF THE MONTH.
WE ADVANCED BEYOND THAT.
THE NEXT CHALLENGE WE FACED WAS
WHEN WE TRANSITIONED OUR WORK
SPECIFICALLY TO LOOK AT
ENDOMETRIOSIS IN 2016, A LOT OF
PEOPLE COULDN'T PRONOUNCE
ENDOMETRIOSIS SO WE JUST KEEP
TACKLING THESE CHALLENGES AND
THE LANDSCAPE KEEPS GETTING
BETTER AND BETTER SO IT'S VERY
EXCITING. I WANT TO SHARE WITH
YOU THIS DIAGNOSTIC PLATFORM
WE'VE BEEN BUILDING FOR THE PAST
DECADE, AND SOME OF THE SORT OF
CORE HYPOTHESES WE'VE BUILT IT
ON THE DATA WE'VE GENERATED AND
MOST IMPORTANTLY THE CHALLENGES
WE HAVE FACED AND CONTINUE TO
FACE AND HOPE TO HAVE
INTERDISCIPLINARY APPROACHES TO
TACKLE.
SO I'LL START WITH THIS SLIDE
BECAUSE THE CORE THESIS OF OUR
COMPANY REALLY IS THAT THE
UTERUS IS AN EXQUISITELY
SENSITIVE AND RESPONSIVE ORGAN
THAT ESSENTIALLY TAKES ALL OF
ITS MARCHING ORDERS FROM A
BEAUTIFULLY COORDINATED HORMONAL
CASCADE.
WHEN TO GROW, WHEN TO SHED, WHEN
TO BECOME PLACENTA.
SO ANYTHING -- ANY HORMONAL
CHANGE, NO MATTER HOW SUBTLE
HAPPENS, IT SHOULD SHOW UP IN
THE UTERINE LINING THAT'S SHED
EVERY SINGLE MONTH IF YOU ARE
ACTUALLY PROFILING IT A AT A VEY
GRANULAR LEVEL.
THTHE GREAT THING ABOUT IT IS IF
YOU BELIEVE THESE MOLECULAR
CHANGES ARE DETECTABLE, EVEN IF
THEY'RE VERY SMALL, YOU CAN
ACCESS THEM THROUGH MENSTRUAL
BLOOD BECAUSE THERE IS THIS VERY
REGULAR NATURAL BIOPSY THAT IS
PRODUCED EVERY SINGLE MONTH FOR
DECADES IN FEMALE-BORN BODIES.
SO IF YOU CAN SIMPLIFY AND
CREATE AN ELEGANT WAY TO COLLECT
IT AND THEN STANDARDIZE HOW DO
YOU ACTUALLY GENERATE THESE AND
CHARACTERIZE THESE UTERINE
PROFILES, YOU MIGHT BE ABLE TO
DO SOMETHING PROFOUND.
AND THEN AGAIN, THE CONTEXT IS,
IS THAT IF THERE ARE SHIFTS IN
HORMONE PROFILE, WHETHER IT IS
YOU'RE LOOKING AT AN
ESTROGEN-DOMINANT DISEASE LIKE
ENDOMETRIOSIS OR YOU'RE LOOKING
AT PCOS, THAT YOU SHOULD NOTICE
A DIFFERENT UTERINE RESPONSE.
ALL OF THIS IS SORT OF BASED ON
WHAT I CALL ALARMINGLY MUNDANE
PROCESSES, WHICH IS HOW DO YOU
STANDARDIZE ALL OF THIS?
HOW DO YOU STANDARDIZE SAMPLE
COLLECTION?
WHAT TAMPON DO YOU USE?
AND YOU SAW PEOPLE USING PADS,
PEOPLE HAVE USED MENSTRUAL CUPS.
WHAT PLATFORMS ARE YOU ACTUALLY
RUNNING ON THE SAMPLES THAT YOU
COLLECT?
ARE YOU DOING SEQUENCING, ARE
YOU DOING PROTEOMICS?
WHAT ARE YOU LOOKING AT?
AND THEN HOW ARE YOU THINKING
ABOUT THE DATA ANALYTIC AND
BIOINFORMATIC PIPELINES?
I WILL GET INTO ALL OF THOSE
THINGS BUT, YOU KNOW, THE
NEAR-TERM GOAL FOR US THAT WE
REALLY HAVE SPENT A LOT OF TIME
LOOKING AT IS, CAN YOU ACTUALLY
FIND A PREDICTION BLI ALTERED
UTERINE RESPONSE TO
ENDOMETRIOSIS?
SO THIS WAS WORK THAT WE STARTED
IN 2016 WHEN WE COLLECTED OUR
FIRST TAMPONS FROM INDIVIDUALS
WHO HAD ENDOMETRIOSIS AND
COMPARED THEM TO HEALTHY
CONTROLS.
WE USED THAT DATA TO GET OUR
FIRST NIH SBIR OF $1.8 MILLION
THAT REALLY FUELED A LOT OF OUR
VALIDATION STUDIES, SO THEN WE
TOOK THE INITIAL SIGNAL WE
FOUND, WE VALIDATED IT IN AN
INDEPENDENT DATASET AND NOW
WE'RE LOOKING AT HOW WELL THIS
CLASSIFIER WORKS IN INFERTILITY
POPULATIONS SPECIFICALLY.
I WANT TO MENTION AS YOU GUYS
KNOW, A LOT OF CLINICIANS AND
SCIENTISTS IN THE ROOM ARE VERY
FAMILIAR WITH THIS CONDITION.
IT'S EXTREMELY COMPLEX.
IT HAS A LOT OF COMORBIDITIES.
PEOPLE WHO HAVE ENDOMETRIOSIS
OFTEN HAVE INFERTILITY, THEY
ALSO OFTEN HAVE AUTOIMMUNE
CONDITIONS, IBS, ET CETERA, SO
PATIENTS WILL COME TO CLINICIANS
WITH A VERY GENERIC SET OF
SYMPTOMS.
AND SO A LOT OF THE DIAGNOSIS,
IF IT DRIVEN BY PATIENTS
RECOGNIZING THEIR SYMPTOMS, IT'S
SORT OF INHERENTLY SUBJECTIVE.
IS MY BLEEDING, IS MY MENSTRUAL
BLEEDING ACTUALLY HEAVY?
I DON'T KNOW.
IS THERE SOME SORT OF STANDARD
THAT'S BEEN RELEASED SOMEWHERE?
IS MY BLEEDING -- IS THIS PAIN
THAT I'M EXPERIENCING
CYCLICICALLY, IS THIS REALLY
EXTREME OR IS THIS JUST WHAT
EVERYONE EXPERIENCES ON A
MONTHLY BASIS?
SO THERE'S JUST SO MUCH INHERENT
SUBJECTIVITY IN THE PATIENT
EXPERIENCE, THAT ADDS TO THE
CONFUSION AND DIAGNOSIS.
FIRST LINE OF DEFENSE,
ESPECIALLY IF YOU ARE A
TEENAGER, AND YOU'RE GOING TO A
PEDIATRICIAN OR A GP, IS NOT
GOING TO BE SOMEONE WHO HAS THE
TOOL SET TO ACTUALLY MAKE THE
DIAGNOSIS IMMEDIATELY, RIGHT?
THIS TAKES A SPECIAL -- WHO
KNOWS HOW TO RECOGNIZE THE
SYMPTOMS, SO THERE'S A LOT OF
AMBIGUITY IN THAT CLINICAL
INTERPRETATION, DEPENDING ON
WHAT TYPE OF DOCTOR THAT YOU
ENCOUNTER FIRST.
AND PART OF WHAT'S INTERESTING
ABOUT THIS CONDITION IS THAT SO
MUCH OF THE FOUNDATIONAL
UNDERSTANDING IS BASED ON
ANATOMICAL FEATURES.
IS THERE AN ENDOMETRIOMA, WHEN
REALLY IT SHOULD BE DRIVEN BY
MOLECULAR CLASSIFICATION WHICH
WOULD THEN DRIVE BETTER DRUG
DEVELOPMENT.
AGAIN, WORTH HIGHLIGHTING THAT
BASICALLY THE ONLY DRUG MODALITY
WE HAVE FOR ENDOMETRIOSIS IS
PROGESTIN AND GNRH ANALOGS.
THE THESIS BEING IT'S AN
ESTROGEN-DOMINANT DISEASE, LET'S
JUST STOP ESTROGEN AND SEE IF
THIS ACTUALLY MAKES AN IMPACT ON
THE DISEASE.
AND WE NEED BETTER, LESS BLUNT
INSTRUMENTS TO ACTUALLY BE ABLE
TO TACKLE THIS.
SO I'M GOING TO -- THE BIG
CHALLENGE THAT'S BEEN MENTIONED
A COUPLE OF TIMES, I SAW IT IN
JULIE'S PRESENTATION AS WELL,
WHICH WAS THE CHALLENGE THAT
EVERYONE FACES WHEN STUDYING
FEMALE-BORN BODIES IS WE HAVE
THE HORMONE CYCLE AND IT MAKES
EXPERIMENTS EXTREMELY NOISY.
SO ONE OF THE THINGS THAT WE
LIKE TO POINT OUT IS THAT WHAT
MENSTRUATION DOES IS IF YOU'RE
ACTUALLY LOOKING AT A REDUCED
WINDOW, SO DAYS 1 THROUGH 3 OF
MENSTRUATION, FOR EXAMPLE, ALL
OF YOUR PATIENT POPULATION IS
ACTUALLY AT THE SAME PLACE IN
THEIR MENSTRUAL CYCLE.
SO YOU ARE PASSIVELY
BIOLOGICALLY ALIGNING EVERYONE
AND YOU'RE REDUCING ONE OF THE
MOST CONSIDERABLE FACTORS OF
NOISE ACROSS WOMEN'S HEALTH.
ANOTHER ISSUE, AGAIN AS I
MENTIONED, WHAT FORM FACTOR DO
YOU CHOOSE?
WE'VE BEEN ASKED WHY DID YOU
CHOOSE A TAMPON?
YOU SORT OF HAVE TO PICK ONE AND
BRING THAT PRODUCT HOME.
NUMBER TWO, WE WANTED FOR
SOMETHING THAT STAYED IN THE
BODY AS LONG AS POSSIBLE, ALMOST
ACTING LIKE A LITTLE INCUBATOR,
VERSUS ONCE IT OUTSIDE, THE
DEGRADATION IS WORSE.
ONCE WE PICKED A TAMPON, YOU MAY
OR MAY NOT BE AWARE THAT TAMPONS
HAVE A LOT OF ADDITIVES.
IT CAN HAVE BLEACHES, SCENTS
THAT INTERFERE WITH DOWNSTREAM
CHEMISTRY, SO WE HAD TO PICK THE
TAMPON THAT HAD MINIMIZED ALL OF
THOSE VARIABLES, AND THEN WE HAD
TO BUILD A SYSTEM THAT COULD
ELIMINATE COACHING, AND THAT WAS
REALLY IMPORTANT FOR US BECAUSE
WE REALLY FEEL LIKE TRYING TO
COLLECT SAMPLES AT HOME
DECREASES ACTIVATION AND ENERGY
AND GETS PEOPLE TO PARTICIPATE
IN THEIR HEALTHCARE IN A MUCH
MORE MEANINGFUL LEVEL.
SO WHAT YOU'RE LOOKING AT IS ONE
OF OUR NEXTGEN JANE KITS THAT
HAS BEEN IN OUR CLINICAL STUDIES
FOR YEARS, AND IS ABLE TO
PRESERVE HIGH FIDELITY DNA AND
RNA SUCH THAT IT IS USED IN THE
PRIVACY OF A WOMAN'S HOME, IT IS
SNAIL MAILED, USPS, NO COLD
CHAIN, SO NO DRY ICE, NO WET
ICE.
IT HAS UP TO TWO WEEKS TO ARRIVE
AT OUR LABS IN OAKLAND.
WE HAVE TESTED IT AS FAR AWAY AS
ALASKA AND HAWAII, SO OUR
CLINICAL STUDIES ARE NATIONAL.
AND HAS REALLY GREAT ABILITY TO
GIVE US HIGH FIDELITY DNA AND
RNA.
AND SO THIS HAS POWERED ALL OF
OUR STUDIES FOR I WOULD SAY THE
LAST FIVE YEARS, WE'VE LANDED ON
THIS FORM FACTOR.
THERE ARE CHAL THE CHALLENGES TE
FACED IN THE BEGINNING.
WHEN WE WERE LOOKING AT THE
SAMPLE TYPE, IT IS CLOTTED, IT
IS HETEROJ HETEROGENEOUS IT I M.
AND THEN WE HAD TO ACCOUNT FOR
THINGS LIKE VARYING LEVELS OF
DEGRADATION.
PEOPLE WORE THESE TAMPONS FOR
DIFFERENT TIMES.
NO MATTER WHAT YOU SAY IN THE
INSTRUCTIONS FOR USE.
SO HOW DO YOU ACCOUNT FOR THAT
DOWNSTREAM.
ANOTHER PROBLEM WAS DIFFERING
TISSUE COMPOSITION.
SO AS YOU CAN ASK SOMEBODY, TELL
US WHAT DAY YOU WORE THIS
TAMPON, AND CAN YOU GIVE US SOME
SORT OF SENSE WHETHER IT'S HEAVY
FLOW DAY, LIGHT FLOW DAY, MEDIUM
FLOW DAY?
THAT'S REALLY IMPORTANT BECAUSE
TISSUE DIFFERENTIATION IS PROB
BY GPROBABLY GOING TO BE ONE OFE
BIGGEST VARYING DRIVERS -- I
SHOW YOU THIS GRAPH BECAUSE IT
REALLY GIVES YOU A GREAT EXAMPLE
OF HOW IMPORTANT IT IS TO
NORMALIZE THIS DATASET.
ON THE LEFT-HAND SIDE, THE RED
AND YELLOW DOTS, YOU'RE SEEING
SUBJECTIVELY LABELED PLOT OF
PEOPLE TELLING US, I THINK THIS
IS MY HEAVY FLOW DAY, I THINK
THIS IS MY LIGHT, MEDIUM FLOW
DAY, WHAT YOU SHOULD IMMEDIATELY
JUST SEE IS NOISE.
IT'S CHAOS.
THERE'S NO PATTERN THERE.
PEOPLE ARE NOT RELIABLY CALLING
WHAT DAY THEY'RE ON.
ON THE RIGHT-HAND SIDE, WE
DEVELOPED A MOLECULAR LABELING
SYSTEM, WE SAMPLED PEOPLE EVERY
SINGLE DAY OF THEIR MENSTRUAL
CYCLE AND WE SAID THIS IS
HEAVIEST FLOW DAY, THIS IS
ABSOLUTELY NO BLEEDING.
IF YOU USED THAT ACTUALLY
DATA-DRIVEN APPROACH TO
MOLECULARLY LABEL THESE SAMPLES,
BOOM, YOU GET THIS IMMEDIATE
PATTERN.
SO IT REALLY WAS YEARS OF
DEVELOPING THESE NORMALIZATION
STRATEGIES THAT TOOK A LONG
TIME, BUT GOT YOU TO A PLACE
THAT WHEN YOU'RE COMPARING
SAMPLES FROM INDIVIDUALS, YOU
KNOW WHAT YOU'RE LOOKING AT IS A
DIFFERENCE THAT COULD BE
ATTRIBUTABLE TO BIOLOGICAL
PHENOMENON AND NOT AN ARTIFACT.
ALL RIGHT, OTHER CHALLENGES.
THERE ARE CHALLENGES DEFINING
WHAT A CASE IS.
THE LAPAROSCOPY IS REFERRED TO
AS A GOLD STANDARD.
I ONCE HEARD SOMEONE VERY
BRILLIANTLY REFER TO IT AS A
BRONZE STANDARD, WHICH IS --
SOME SURGEONS WILL GO IN AND
THEY WON'T TAKE A BIOPSY FOR THE
PATH LAB.
IS THAT AN ENDOMETRIOSIS CALL?
SOMEONE WILL, YOU KNOW, GET 20
BIOPSIES AND ONE IS CALLED
POSITIVE.
DO YOU WANT TO CALL THAT AN
ENDOMETRIOSIS PATIENT?
SOMEONE WILL GO IN AND THEY HAD
ENDOMETRIOSIS THREE YEARS AGO,
THEY HAD MOST OF THE TISSUE
REMOVED AND THEY COME TO YOU AND
THEY'RE LIKE, I HAVE
ENDOMETRIOSIS.
HOW DO YOU CLASSIFY THEM?
DO THEY STILL HAVE
ENDOMETRIOSIS?
AND SO THERE'S A LOT OF
CHALLENGES REALLY HONING IN AND
BEING VERY PRECISE ABOUT WHAT A
CASE IS.
SAME CHALLENGES IN DEFINING WHAT
A CONTROL IS.
WURNTION THERE'S A SCARCITY OF
TRUE ENDO NEGATIVE CONTROLS.
THERE ARE OTHER CHALLENGES.
EVEN PEOPLE WHO ARE
ENDO-NEGATIVE, THEY COME IN AND
THEY SAY I HAD A LAP THREE YEARS
AGO WHEN WE'VE ACTUALLY HAD
PEOPLE IN OUR TRIALS WHO HAD
LAPS TWO YEARS AGO, E
ENDO-NEGATIVE, STILL HAD
SYMPTOMS, THEY WENT TO A
DIFFERENT SURGEON, THEY'RE
ENDO-POSITIVE.
SO THERE'S A LOT OF
SUBJECTIVITY, SURGEON SKILLSET.
THERE'S A LOT OF NOISE IN THE
SYSTEM THAT CAN MAKE DEFINING
WHAT A CONTROL IS CHALLENGING.
THERE ARE CHALLENGES IN -- ONE
IS DIAGNOSTIC REIMBURSEMENT, SO
WE HEARD A LOT BL INVESTING IN
THE SPACE AND INVESTMENT FOR
DIAGNOSTICS IN GENERAL IS
CHALLENGING BECAUSE IT'S NOT AS
LUCRATIVE FROM AN ROI
PERSPECTIVE DOLLAR FOR DOLLAR
THAT YOU PUT INTO A DRUG, YOU'RE
GOING TO GET A HIGHER RETURN
INTO DEVELOPMENT OF DIAGNOSTIC.
THE OTHER THING IS THAT WE ARE
IN A COMMERCIAL REIMBURSEMENT
SYSTEM FOR WOMEN WHO ARE OF
REPRODUCTIVE AGE THROUGH THE
RUBRIC THAT INSURANCE COMPANIES
USE TO SAY CAN YOU SAVE ME MONEY
WITH THIS DIAGNOSTIC IN 12
MONTHS, WHICH IS ABOUT ON
AVERAGE HOW LONG I WILL HOLD ON
TO THIS PATIENT.
SO THIS IS PRIVATE PAYERS.
SO IF YOU ARE DIAGNOSING SOMEONE
WITH ENDOMETRIOSIS
NON-INVASIVELY, YOU'VE MADE THAT
PROCESS VERY EASY, YOU ARE
LIKELY INCREASING THE COST OF
THAT HUMAN BEING WHILE THEY ARE
BEING COVERED BY THAT COMMERCIAL
PAYER.
SO INCENTIVES AREN'T QUITE THERE
TO ACTUALLY MAKE THIS SOMETHING
THAT INSURANCE COMPANIES WANT TO
REIMBURSE.
BUT WE KEEP GOING BECAUSE THE
RESEARCH ON ENDOMETRIOSIS IS
CLEAR.
HIGHER RATES OF INFERTILITY,
HIGHER RATES OF OVARIAN CANCER,
PREECLAMPSIA, PRETERM LABOR.
AND THIS IS A BIG FOOTPRINT.
10% OF ALL FEMALE-BORN BODIES
AFFECTED BY THIS DISEASE.
SO ALL OF THOSE CHALLENGES
BECOME WORTH TACKLING.
I'LL JUST POINT OUT A COUPLE
OTHER THINGS.
WE'RE OBVIOUSLY WORKING ON A
NONINVASIVE DIAGNOSTIC, BUT IT
COULD BE, IF IT WORKS, AN
EVALUATIVE PLATFORM, SO YOU
COULD IMAGINE NOW IN CLINICAL
TRIALS, YOU TAKE A TAMPON-BASED
TEST, DETERMINE WHETHER YOU HAVE
THE DISEASE, YOU ADMINISTER A
SMALL MOLECULE, YOU TAKE A TAM
TAMPON-BASED TEST SIX MONTHS
LATER, REALLY SIMPLIFYING HOW
YOU DO CLINICAL RESEARCH.
THE OTHER OPPORTUNITY IS
PRE-CLINICAL IMPACT.
WE'VE ACTUALLY TAKEN MENSTRUAL
BLOOD COLLECTED IN CUPS, WHICH
HAS LIVE CELLS, AN WE HAVE
INTRODUCED DIFFERENT
CONCENTRATIONS OF DRUGS AT
DIFFERENT TIME POINT AND DONE
SEQUENCING ON BOTH THE VEHICLE,
NO DRUG, AND ALL THESE
EXPERIMENTAL CONDITIONS TO BE
ABLE TO STEAP WH ESTABLISH WHATS
CHANGING AND WHAT IT'S DONE TO
HELP DRUG DEVELOPERS UNDERSTAND
MECHANISM OF ACTION.
SO THERE ARE JUST MANY
INTERESTING THINGS YOU CAN DO
WITH THIS SAMPLE TYPE AND I
THINK A LOT OF PEOPLE ARE
BEGINNING TO RECOGNIZE THAT
EVERY TIME SOMEONE HAS MENTIONED
A MENSTRUAL E EFFLUENCE EFFORT
HERE BEFORE, JULIE ELBOWED ME
AND HE SAID WAS THAT YOU, AND
THE SPACE IS HOT NOW WHICH WE
LOVE.
I JUST -- THE NUMBER ONE THANK
YOU I WANT TO GIVE IS TO OUR
CLINICAL TRIAL PARTICIPANTS.
THEY HAVE GIVEN US OVER 2,000
TAMPONS AND NONE OF THIS WOULD
BE POSSIBLE WITHOUT THEM.
THANK YOU.
>> I'D LIKE TO INVITE EACH OF
OUR SPEAKERS UP TO JOIN ME ON
THE PANEL.
WE'LL HAVE A BRIEF MODERATED
DISCUSSION AND I WILL, OF
COURSE, LEAVE ROOM FOR OUR
COUNCILMEMBERS TO QUERY AS WELL.
>> THAT WAS FANTASTIC OBVIOUSLY.
YOWE DID A GREAT JOB CHOOSING OR
PANELISTS.
AND WE ALSO COVERED SEVERAL
DIFFERENT AREAS AND BASES BUT
ONE THING I REALLY WANT TO HIT I
THINK EACH OF YOU TOUCHED ON IN
DIFFERENT WAYS AND I THINK IT'S
A CONCERN OF THE PUBLIC, DATA.
THE MANAGING IT, YOU COLLECTED
LARGE AMOUNTS OF VERY PERSONAL
SPECIFIC DATA, WE THINK ABOUT
SAFETY, WE THINK ABOUT
CONVINCING PATIENTS TO PROVIDE
THE DATA AND WE THINK ABOUT
USING DATA AND DATA OF YOUR
COMMERCIAL ENTITY IS ALSO A
COMMODITY.
JUST CURIOUS HOW YOU ALL THINK
ABOUT DATA IN THE ASPECTS OF
YOUR WORK AND WHAT WE NEED TO BE
THINKING ABOUT.
>> YOU'VE MENTIONED ALL THE DATA
WE COLLECTED.
WE HAVE A VERY EXPLICIT APPROACH
OF PERMISSING THE DATA, THIS IS
A 30-MINUTE CALL, WALKING THEM
THROUGH CONSENT, EXPLAINING ALL
OF THE RESEARCH PRIORITIES THAT
WE'RE PRESUMING AND MAKING SURE
THEY UNDERSTAND THAT, AND SO
EVERY SAMPLE THAT IS IN OUR
DATABASE AND OUR BIOBANK IS
EXPLICITLY CONSENTED TO BE USED
FOR THAT RESEARCH.
WE ALSO GO THROUGH THE EFFORT OF
DE-IDENTIFYING IT SO WE GIVE
THEM ALL ALPHANUMERIC IDs AND
AFTER A CERTAIN AMOUNT OF TIME,
WE'RE OBLIGATED TO KEEP THE
CONNECTION, THE LINK BETWEEN
THEIR IDENTITY AND THEIR
ALPHANUMERIC CODE FOR ABOUT FIVE
YEARS.
AFTER THAT, WE DESTROY IT AND
THERE'S NO WAY FOR US TO EVEN
LINK BACK TO WHO IT IS.
SO WE TRY TO BE BOTH UP FRONT
ABOUT WHAT WE'RE GOING TO DO AND
GET PERMISSION TO USE THE DATA
EXACTLY HOW WE'RE GOING TO USE
IT AND THEN WE ARE VERY THOROUGH
ABOUT MAKING SURE WE'RE
DE-LINKING IT FROM WHO THE
PERSON ACTUALLY IS.
>> I THINK FROM A RESEARCH
PERSPECTIVE, THERE'S NO QUESTION
THAT DATA IS THING THAT WE'RE
MISSING THE MOST IN WOMEN'S
HEALTH.
I RAN A WORKSHOP THIS SUMMER ON
ENGINEERING AND WOMEN'S HEALTH
AND SOME OF THE PEOPLE IN THE
ROOM WERE THERE.
I DID AN ANALYSIS, JUST A
TEXT-BASED ANALYSIS OF ALL OF
THE NOTES FROM THAT ENTIRE
MEETING, AND THE SINGLE MOST
COMMONLY UTTERED WORD IN THOSE
NOTES WAS "DATA," BECAUSE ALL OF
US WHO ARE RESEARCHERS IN THIS
FIELD REALLY ARE LACKING DATA,
AND I GAVE THE EXAMPLE ALREADY
OF MIDRC AND HOW YOU HAVE -- IF
YOU WANT TO TRAIN AN A.I. MODEL
ON THOUSANDS OF COVID LUNGS, YOU
CAN VERY EASILY DO THAT.
IF YOU WANT TO DO SOMETHING LIKE
THIS IN WOMEN'S HEALTH, YOU HAVE
TO COLLECT THE DATA
PROSPECTIVELY.
NOW THE GOOD THING FROM MY
PERSPECTIVE IN THE YEARS I'VE
BEEN DOING THIS IS, I HAVE FOUND
MOST PREGNANT WOMEN TO BE
EXTREMELY GENEROUS WITH THEIR
GIVING CONSENT TO PARTICIPATE IN
THE RESEARCH FOR US TO KEEP THE
IMAGES.
WE DON'T DO ANYTHING WITH
GENETICS, AND I THINK THAT DOES
HELP US A LITTLE BIT BECAUSE
WE'RE MOSTLY COLLECTING IMAGING
DATA AND CHART KIND OF DATA AND
ALSO DE-IDENTIFYING EVERYTHING,
AND WE TREAT THAT DATA LIKE GOLD
AND WE USE IT OVER AND OVER AND
OVER AGAIN AND THAT'S PART OF
OUR INITIAL CONSENT PROCESS
BECAUSE THIS DATA IS SO
PRECIOUS, THERE'S SO LITTLE OF
IT AND WE NEED SO MUCH MORE OF
IT.
>> OKAY, GREAT.
THANK YOU FOR THAT.
AND JULIE, I DO WANT TO TURN TO
IT BECAUSE YOU SAID YOU WEREN'T
AN ENGINEER, THEN YOU WENT TO
EVATAR, YOU WANTED TO MAKE IT
FASTER, BETTER, CHEAPER, THAT'S
WHAT THEY DO TO GET TO LATTICE,
TO THE LATTICE MODEL.
BUT ALSO PCOS, HOW THAT HASN'T
COME UP A LOT AND HOW THAT
INFLUENCES MANY OF THESE OTHER
DISEASES THAT THE OTHER TWO
RESEARCHERS WERE DISCUSSING.
SO WHEN I HEAR ABOUT ALL THIS, I
HAVE FRIENDS WITH MULTIPLE
CROSSOVER ISSUES, AND I REALLY
BEGIN TO THINK ABOUT THIS AS
THIS N OF 1 ISSUE, RIGHT?
IT'S NOT -- WE COLLECT DATA TO
TRY TO DO AVERAGES, THAT DOESN'T
WORK FOR ALL WOMEN AS WE'VE BEEN
HEARING ABOUT.
I'M CURIOUS HOW YOU THINK ABOUT
AN N OF 1, HOW YOUR TOOLS MIGHT
HELP INFORM A PATIENT AND A
CLINICIAN, HOW TO DEAL WITH ME
VERSUS THE BROADER POPULATION.
>> THAT'S A GREAT QUESTION.
I TALKED A LITTLE BIT ABOUT THIS
IN ANOTHER TALK, BUT I THINK THE
WAY TO STUDY THOSE DISEASES IS
TO LOOK AT THE GENETICS.
PCOS DOES HAVE A GENETIC
COMPONENT.
BUT IF WE WERE ABLE TO GET AND
INDUCE PLAWR EE POTENT STEM
CELLS IN A PATIENT WITH PCOS
AND -- CELLS INTERESTED IN
WORKING TOGETHER, THAT WOULD BE
MORE OF A PERSONALIZED PLATE
WHERE YOU CAN TRY DRUGS, ET
CETERA, AND ULTIMATELY AT THE
END OF THE DAY, THAT'S WHAT WE
WANT.
WE WANT TO STUDY EACH PATIENT
AND THEIR CONDITIONS AND THEIR
GENETICS ALL IN ONE, AND SEE
WHAT IS THE OVARY DOING OR
GRANULOIS A CELLS DOING WHRA IS
THE LIVER DOING, WHAT IS THE
PANCREAS DOING.
SO I THINK THAT IS THE WAY TO GO
WHEN WE TALKED ABOUT A LOT OF
THE NOISE WE TALKED ABOUT,
HETEROGENEITY, TO BE ABLE TO
LOOK AT IT IN A PERMIZED MATTER.
>> AND WHAT MEDICAL EDUCATION DO
YOU THINK NEEDS TO BE DEVELOPED
FOR THE CLINICIANS TO BUY INTO
THE DATA OR THE N OF 1 YOU
PREDICTED IN YOUR MODELS?
EDUCATION FOR THE CLINICIAN, TO
COME IN AND SAY I WOULD BELIEVE
THIS DATA AND APPLY TO MY
PATIENT.
>> YES, WE WOULD HAVE TO PROVIDE
THEM CONVINCING DATA, NOT AN N
OF 1, BUT LET'S SAY A VILLAGE OF
PEOPLE AND LINK THAT INTO A
CERTAIN PHENOTYPE, FOR EXAMPLE.
SO AGAIN, DATA COLLECTION,
CONVINCING CLINICIANS THAT THIS
IS THE WAY TO GO, LOOK AT THE
DIFFERENT PATIENTS THAT WE HAVE
ON THIS PLATE, LOOK HOW
DIFFERENTLY THEY'RE RESPONDING
TO DIFFERENT MEDICATIONS AND
PROVIDE THEM WITH SUFFICIENT
DATA.
>> BACK TO YOU, MICHELLE.
THE DIGITAL TWINS, A DIFFERENT
TAKE ON THE N OF 1 MODEL, BUT
ALSO WHEN I LISTENED TO THE
THREE OF YOU SPEAK, SURGERIES
DIDN'T COME UP MUCH, MAYBE IT'S
A GOOD THING, MAYBE IT'S NOT.
I WONDER, MICHELLE, IN SOME OF
YOUR MODELS WHERE YOU TALKED
ABOUT CESAREAN SECTIONS, THAT
WAS CHANGED.
NOW AS YOU DO THESE NEW MODELS,
ARE THEY TO INFORM SURGICAL
ADVICE, TREATMENTS, THERAPIES OR
WHAT WOULD THE CLINICIAN BE
ASKED TO DO ON THE OTHER SIDE OF
RECEIVING YOUR ANALYSIS AND
AGAIN, HOW WOULD YOU TAKE THAT
ON THAT WALK WITH YOU AS YOU'VE
BEEN DEVELOPING THESE DIFFERENT
PRAK CYSTS SO THEN THEY'RE READY
TO DO THIS AND BELIEVE?
>> SO I MEAN, THE REASON WE'RE
DOING SOME OF THIS MODELING BOTH
IN THE CONTEXT OF THE PLACENTA
AND THEN THE CONTEXT OF THE
C-SECTION IS TO INFORM WHETHER
OR NOT PEOPLE NEED C-SECTIONS
AND WHETHER OR NOT THEY NEED
THEM EARLY.
SO WITH PLACENTA MALFUNCTION,
YOU OFTEN HAVE A HIGH RATE OF
STILLBIRTH, SO THEY WILL GO IN
AND DO A PROPHYLACTIC C-SECTION
BUT THAT THEN LEADS TO AN
INDUCED PRETERM BIRTH.
OR WITH SOMEONE WHO'S HAD A
PREVIOUS C-SECTION IN AMERICA,
THEY WILL SCHEDULE ANOTHER
C-SECTION ALMOST BY DEFAULT.
THE RATE OF VAGINAL BIRTH AFTER
CESAREAN SECTION PREVIOUSLY IS
WELL OVER 50% IN PLACES LIKE
SCANDINAVIA -- I'M NORWEGIAN SO
I CAN KEEP REFERRING TO
SCANDINAVIA.
BUT SO IN OTHER PLAWS PLACES, M,
MANY WOMEN HAVE A SUCCESSFUL
VAGINAL BIRTH AFTER C-SECTION,
IN THE UNITED STATES, ANOTHER
C-SECTION IS ALMOST ROUTINELY
SCHEDULED.
SO THAT'S ANOTHER PERVASIVE
PROCEDURE THAT HAS MAJOR
ABDOMINAL COMPLICATIONS FOR A
WOMAN WHO'S TRYING TO HOLD A
NEWBORN BABY WITH A
10-CENTIMETER GASH ACROSS HER
FRONT.
SO THE IDEA IS TO TRY TO REDUCE
THE C-SECTION RATE AND
PARTICULARLY IN THE CAUSE OF
POSSIBLE STILLBIRTH, TO REDUCE
THE EARLY C-SECTION RATE.
IF WE CAN USE OUR DIGITAL TWINS
TO SAY WE CAN DETECT THAT THE
PLACENTA IS FUNCTIONING, YOU
DON'T NEED TO DO A C-SECTION
EARLY, YOU DON'T NEED TO INDUCE
A PRETERM BIRTH, THAT WOULD BE
GREAT.
IF WE COULD DE-RISK A VBAC AND
ALLOW WOMEN TO CHOOSE TO HAVE A
VAGINAL BIRTH OR AT LEAST AN
ATTEMPT AT A TRIAL OF LABOR
BEFORE JUST ASSUMING A
C-SECTION, THESE ARE BOTH THINGS
THAT WOULD IMPROVE WOMEN'S LIVES
BY REDUCING THE C-SECTION RATE.
AND SO WE ARE HOPING TO GET
THESE INTO CLINICAL PRACTICE
WITH PROSPECTIVE TRIALS IN THE
VERY NEAR FUTURE.
>> OKAY, WOW, THAT'S GREAT.
THIS WILL BE MY LAST QUESTION
BEFORE I OPEN UP TO THE COUNCIL.
I WANT TO LEAVE YOU ALL SOME
TIME AND I THINK THIS IS MAYBE
FOR MS. TARIYAL AND KIM.
YOU'VE LISTED SOME OF THE
CHALLENGES.
I'M GOING TO ASK THE WORST
QUESTION THAT I COULD PROBABLY
ASK IN THIS FORUM.
IF YOU SAID IT APPLIED TO MEN IN
SOME ASPECT, WOULD THAT MAKE THE
COMMERCIALIZATION EAZIER?
COMMERCIALIZATION EASIER?
IT DOESN'T HAVE TO BE FOR
WOMEN'S REPRODUCTIVE HEALTH.
I'M CURIOUS IF THAT'S A GOOD
APPROACH AND HOW HAVE YOU
RECEIVED THOSE MESSAGES IF THEY
WERE CORRECT?
>> WHEN WE WERE FIRST MAKING
EVATAR, WE ALSO HAD A MALE
VERSION, AND TERESA CALLED IT
THE DUDE CUBE.
[LAUGHTER]
AND PEOPLE WERE REALLY
INTERESTED IN THAT.
I DON'T KNOW IF IT WERE MEN OR
WOMEN, BUT WHAT ABOUT -- A LOT
OF TIMES WHEN WE PRESENTED
EVATAR, ULTIMATELY THE QUESTION
IS, DO YOU HAVE A MALE VERSION?
DO YOU HAVE A MALE VERSION?
SO I THINK -- I DON'T KNOW THE
ANSWER TO YOUR QUESTION.
BUT THE FACT THAT WE ARE ALL --
THIS IS THE CENTER OF WOMEN'S
HEALTH RESEARCH, I'M SO HAPPY
ABOUT THAT.
WE NEED TO PUSH THIS AGENDA
FORWARD.
>> I AM IN THE UNIQUE POSITION,
MY PRODUCT CAN'T BE USED -- YOU
KNOW, FOR BETTER OR FOR WORSE.
WOULD IT IMPROVE INVESTING?
MAYBE.
YOU KNOW, I THINK THAT THE
BIGGEST PROBLEM IS JUST THAT THE
PEOPLE THAT UNDERSTAND THE
CHALLENGES OF MENSTRUAL
DISORDERS AND THE LONG-TERM
IMPACT, AND IT'S VERY CLASSIC,
IF YOU HAVE LIVED EXPERIENCE,
YOUR MORE EMPATHETIC T TO IT AND
YOU WANT TO FIND SOLUTIONS AND
YOU KNOW WHAT IT MEALS LIKE TO
GO THROUGH THIS, SO THAT
PROBABLY WAS A BIG MISS TO SAY
MOST INVESTORS DON'T HAVE THAT
LIVED EXPERIENCE SO YOU HAVE
TROUBLE BRIDGING THAT EMPATHY
GAP, SO I DON'T KNOW THAT -- I
WAS BEING FACETIOUS, I DON'T
KNOW THAT I NEEDED TO ACTUALLY
WORK FOR MEN, BUT IT WOULD HAVE
BEEN NICE IF THERE WERE MORE
WOMEN WHO HAD BIGGER
CHECK-WRITING POWER.
>> I'LL OPEN UP TO QUESTIONS
FROM THE COUNCIL.
OR I'M HAPPY TO KEEP GOING.
>> THANK YOU FOR THE GREAT
PRESENTATION, AND SO YOU SHOWED
INNOVATIVE RESEARCH APPROACH
REGARDING MAINLY APPLICATION FOR
EITHER C-SECTION AND
ENDOMETRIOSIS.
SO I WAS WONDERING IF YOU GUYS
THINK THAT THESE METHODS COULD
ALSO APPLY IN THE CONTEXT OF
FIBROIDS, BECAUSE WE DO KNOW
THAT WHEN SOMEBODY HAS A
MYOMECTOMY, THERE'S GOING TO BE
SCAR TISSUE AND THEN IF THERE'S
A SUBSEQUENT PREGNANCY, THEY'RE
GOING TO GO TOWARDS A C-SECTION
BY PREVENTIVE MEASURE.
AND ALSO, IF ESTABLISHING A
TRANSCRIPTOMIC PROFILE WITH THE
MENSTRUAL BLOOD COULD ACTUALLY
HELP IN THE TREATMENT OF
FIBROSIS.
OR FIBROIDS.
THANKS.
>> I LOVE THAT QUESTION.
THANK YOU SO MUCH FOR ASKING IT.
WE'RE DEEPLY INTERESTED IN
FIBROIDS, BIG STRUCTURAL CHANGES
IN ENDOMETRIUM, ENDOMETRIAL
CANCER.
ARE WE TRYING TO BE VERY CAREFUL
ABOUT HOW MUCH WE TAKE ON ALL AT
ONCE, BUT I WILL TELL YOU THAT
BECAUSE WOMEN HAVE SO MANY
COMORBIDITIES, YOU ALMOST CAN'T
AVOID IT.
WE ARE RUNNING AN ENDOMETRIOSIS
TRIAL AND WE HAVE PEOPLE WITH
FIBROIDS, WITH ADNO, SO WE ARE
BUILDING THAT DATABASE TO SAY AT
SOME POINT, YOU'LL HAVE A BIG
ENOUGH N THAT YOU CAN ACTUALLY
USE THE SAME TRAINING SET TO
LOOK AT FIBROIDS, EVEN THOUGH IT
WAS COLLECTED FOR ENDOMETRIOSIS.
>> CAN I ASK A FOLLOW-UP THERE?
HAVE YOU HAD ANY PATIENT THAT
BASED ON YOUR PROFILING YOU TOLD
THEM OF A CONDITION THAT THEY
WERE NOT AWARE THAT THEY HAD?
>> WE'RE NOT ALLOWED TO DO THAT
BY OUR IRB.
>> OKAY, WOW.
OTHER QUESTIONS FROM THE
COUNCILMEMBERS?
YES, PLEASE.
>> THANK YOU ALL SO MUCH FOR ALL
OF THOSE TALKS AS AN OB-GYN, I
FELT REALLY INVIGORATED TO SEE
WHAT WORK WAS BEING DONE, BUT
NOW SELFISHLY I WANT TO KNOW HOW
I CAN USE IT RIGHT NOW.
AND I GUESS MY BROAD QUESTION
IS, TO ME, I SEE THIS AS THE
FUTURE OF LIKE WHAT PRECISION
MEDICINE LOOKS LIKE FOR
PATIENTS, SO I OFTEN FIND MYSELF
COUNSELING PEOPLE, WELL, YOU
HAVE PCOS BUT IT'S A SPECTRUM,
SO YOU MAY BE X AND INSERT, YOU
KNOW, A VARIETY OF THINGS THAT
VARY.
HOW FAR AWAY DO YOU THINK WE ARE
FOR ME BEING ABLE TO SAY, LIKE,
YOU HAVE THIS TYPE, SO WE'RE
GOING TO DO X TO MAKE SURE
YOU'RE BEST TREATED.
>> TO ME, I'LL ANSWER FOR
ENDOMETRIOSIS FIRST.
I THINK THAT THE GOAL WOULD BE,
AND IT IS ACTUALLY REALLY PART
OF OUR VISION TO DO THIS FOR
EVERY REPRODUCTIVE DISORDER TO
BE ABLE TO MOLECULARLY CLASSIFY
IT SO YOU CAN MAKE THE DI TINGS
THAT YOU'RE TALKING ABOUT.
FOR ENDOMETRIOSIS, PART OF OUR
MANDATE IS NOT JUST YOU HAVE
ENDOMETRIOSIS, BUT A THIRD OF
WOMEN DON'T RESPOND TO HORMONE
THERAPY.
SO YOU SHOULD KNOW THAT
BEFOREHAND SO YOU'RE NOT
UNNECESSARILY GOING ON HORMONE
THERAPY AND JUST NOT RESPONDING.
OR, THERE ARE MANY DRUGS NOW
BEING DEVELOPED FOR
ENDOMETRIOSIS THAT ARE TARGETING
A PARTICULAR PATHWAY, WE'RE
ACTUALLY WORKING WITH A COUPLE
OF ENDEAVORS TO EXPLORE IF LET'S
JUST SAY A PARTICULAR
INFLAMMATORY PATHWAY IS
ACTIVATED IN ENDOMETRIOSIS
POPULATION SUCH THAT THE
MOLECULE THAT EXISTS TO TARGET
THAT PATHWAY COULD BE USEFUL.
AND IN THAT -- THAT'S PROBABLY
WHAT'S MOST EXCITING TO US, AS
WE MOVE AWAY FROM JUST -- IF YOU
WERE ACTIVATED IN X PATHWAY FOR
ENDOMETRIOSIS, NOW YOU HAVE AN
ENTIRE DIFFERENT WAR CHEST OF
DRUGS THAT YOU CAN ACTUALLY
ACCESS.
AND FOR THAT, I WOULD SAY IT WEE
PROBABLY T MINUS FIVE YEARS
AWAY.
>> I WOULD PROBABLY SECOND FIVE
YEARS AS BEING A REASONABLE TIME
FRAME FOR STARTING TO SEE SOME
OF THESE THINGS.
I THINK PART OF THE CHALLENGE IS
THAT FROM A RESEARCH
PERSPECTIVE, A LOT OF WHAT WE'RE
DOING IS RELATIVELY
STRAIGHTFORWARD AND THAT THE
TECHNOLOGY ALREADY EXISTS.
SO WE DON'T ALWAYS HAVE TO
DEVELOP ALL NEW TECHNOLOGIES.
THERE'S CERTAINLY SOME NEW
TECHNOLOGIES WE HAVE TO DEVELOP,
BUT THERE'S A LOT OF THINGS
WHERE IF WE JUST APPLIED THE
TECHNOLOGIES THAT EXIST ALREADY
IN OTHER AREAS OF MEDICINE TO
WOMEN'S HEALTH, WE COULD DO
THINGS RELATIVELY QUICKLY.
THE CHALLENGE IN THAT AS A
RESEARCHER IS THAT IT VERY HARD
TO GET FUNDING TO DO THINGS THAT
LOOK SIMPLE AND STRAIGHTFORWARD
BECAUSE THEY'RE NOT AT THE
CUTTING EDGE OF DOING NOVEL
THINGS, AND THE PROBLEM WITH
WOMEN'S HEALTH IS THAT BECAUSE
THERE'S SO MANY BLACK HOLES IN
OUR KNOWLEDGE, THIS INTRODUCES
AN INTERESTING CHALLENGE.
SO THAT'S KIND OF WHY I TAKE
EVERY OPPORTUNITY LIKE THIS TO
BE ABLE TO TALK TO PEOPLE ABOUT
WHAT WE DO AND HOW IT DIFFERENT
THAN WHAT'S ALREADY OUT THERE
AND WHERE THERE ARE
OPPORTUNITIES FOR INNOVATION,
USING ENGINEERING IN WOMEN'S
HEALTH, BECAUSE I THINK THERE
JUST NEEDS TO BE SORT OF GETTING
EVERYBODY ON BOARD TO THE IDEA
THAT THIS IS SOMETHING THAT
COULD HAPPEN WITH EXISTING
TECHNOLOGY IF WE COULD JUST PUT
MECHANISMS IN PLACE TO FUND THE
STUDIES THAT NEED TO BE DONE TO
DEMONSTRATE THE THINGS THAT
ALREADY EXIST WOULD BENEFIT
HUMAN HEALTH IN THIS WAY.
>> I JUST WANT TO ADD ALSO THAT
WE HAVE SO MUCH DATA OUT THERE.
THERE'S JUST SO MUCH.
YOU JUST DO WHOLE GENOME
SEQUENCING IN ONE PATIENT,
THERE'S SO MUCH INFORMATION OUT
THERE, AND IT'S JUST A MATTER OF
TRYING TO USE THAT DATA AND LOOK
AT IT IN DIFFERENT AND VERY
CREATIVE WAYS SO THAT YOU CAN
GET NEW INFORMATION OUT OF THAT.
I FEEL LIKE WE HAVE THE DATA, WE
JUST NEED TO MINE THROUGH IT,
AND IT'S GOING TO TAKE A LOT OF
PEOPLE IN DIFFERENT FIELDS TO
COME TOGETHER TO MAKE SENSE OF
IT ALL.
>> YES.
>> IGHO FROM EMORY.
REALLY FASCINATING TO SEE ALL
THESE WONDERFUL ADVANCES.
JUST WONDERING IF YOU'RE
THINKING AHEAD OF DISSEMINATION
IMPLEMENTATION.
WHEN ALL OF THIS BECOMES -- FIVE
YEARS FROM NOW, YOUR TECHNOLOGY
IS READY TO BE ROLLED OUT.
SOME OF THE -- IMPLEMENTATION.
I DON'T KNOW IF YOU'VE BEEN
THINKING ABOUT THAT.
>> ANYONE?
>> FOR US WHEN WE THINK ABOUT
THE PRODUCT GOING TO MARKET, I
THINK THE BIGGEST CHALLENGE THAT
WE CONSIDER IS THAT THE CURRENT
GOLD STANDARD DIAGNOSTIC IS
SURGERY.
AND YOU'RE NOT PROVIDING
SOMETHING THAT'S SIMILAR, YOU'RE
PROVIDING SOMETHING COMPLETELY
NOVEL, WHICH IS A FIRST GENOMIC
WAY TO LOOK AT MENSTRUAL BLOOD,
JUST ADDING LAYERS OF NOVELTY,
RIGHT?
M, SOMETHING THAT A SURGEONWOULO
DESCRIBEMENT SO I THINK FOR US
WHEN WE THINK ABOUT
DISSEMINATION, THE EDUCATION
PIECE, WHO ARE YOU TRYING TO
EDUCATE WITH THIS?
IS IT SURGEONS?
USUALLY -- I'VE BEEN TOLD BY
ALMOST EVERY SURGEON BY THE TIME
THEY GET TO MY OFFICE, I DON'T
NEED ANY HELP IN DIAGNOSING,
WHETHER OR NOT THEY HAVE
ENDOMETRIOSIS.
SO DOES THAT MEAN THAT IT GOES
TO THE GYN?
AND THEN THE LATEST RESEARCH
SHOWS THAT THIS REALLY IS A
CONDITION THAT STARTS AT
MENARCHE.
SO IS IT PEDIATRICIANS THAT
REALLY NEED TO BE TRAINED ON IT,
SO WE NEED TO THINK ABOUT
DISSEMINATION, WE THINK WHO
NEEDS TO BE TRAINED ON THIS AND
IN WHAT WAYS.
>> WE'VE PK VE BECOME VERY INTED
IN ULTRASOUND FOR EVERYTHING
THAT WE'RE DOING BECAUSE OF THE
FACT THAT IT CAN BE DISSEMINATED
ESPECIALLY IN MATERNAL
HEALTHCARE DESERTS HERE IN THE
UNITED STATES AND ESPECIALLY IN
LOW AND MIDDLE INCOME COUNTRIES.
BECAUSE I CAN NOW BUY, AND I
HAVE, AN ULTRASOUND PROBE THAT
IS THE SIZE OF YOUR CELL PHONE
AND THAT TALKS TO MY CELL PHONE
OR MY iPAD, AND, THEREFORE, I
DON'T NEED A FANCY CLINIC-BASED
ULTRASOUND CART.
I CAN USE THIS PROBE AND THE
ADVANTAGE OF THE PROBE IS NOT
ONLY THAT IT'S PORTABLE, BUT
BECAUSE IT'S NOT FROM ONE OF THE
GIANTS IN MEDICAL IMAGING WHO
ARE USED TO THEIR REVENUE
STREAMS, I CAN GET THE RAW DATA.
AND SO NOT ONLY CAN I GET THE
IMAGES FOR BUILDING MY
COMPUTATIONAL MODEL, I CAN ALSO
GET RAW DATA OUT OF THEM AND GET
ADDITIONAL INFORMATION THAT I
DON'T HAVE ACCESS TO IN A
COMMERCIAL ULTRASOUND.
AND SO THE GOLD STANDARD FOR
BUILDING COMPUTATIONAL MODELS IN
THREE DIMENSIONS WOULD BE MRI,
BUT THAT'S NEVER GOING TO BE
CLINICALLY SCALABLE, AND THAT'S
EXACTLY WHY WE'RE FOCUSING
EVERYTHING ON ULTRASOUND.
AND I DIDN'T MENTION IT, WHICH
IS QUITE SURPRISING SINCE IT'S
USUALLY SOMETHING I SPEND A LOT
OF TIME TALKING ABOUT, BUT WE
USE ALL OPEN SOURCE SOFTWARE FOR
OUR MODELING AS WELL, AND SO WE
ARE NOT USING COMMERCIAL
PROPRIETARY MODELING SOFTWARE,
WE ARE, IN FACT, USING FEBIO,
WHICH CAME OUT OF NIH AND IS
OPEN SOURCE.
SO ALL OF THE WORK THAT WE'RE
DOING IS BASED ON PLATFORMS THAT
ARE LOW COST FOR WIDE SCALE
DISSEMINATION INTO NOT JUST
WEALTHY AREAS WITH VERY HIGH
QUALITY MEDICAL CARE.
ESPECIALLY IN THE U.S. RIGHT
NOW, WHERE THE HEALTHCARE
DESERTS FOR MATERNAL CARE ARE
GETTING WORSE.
>> AS FOR OUR DEVICE, I WOULD
LOVE EVERYONE THAT WORKS WITH
CELL CULTURE TO USE IT.
SO IT WOULD BE AN ALTERNATIVE TO
CELL CULTURES.
BUT BEYOND THAT, LIKE I SAID,
WHAT IS THE MARKET?
BEYOND RESEARCH?
WE CAN TRANSLATE THAT INTO
ANYTHING THAT REQUIRES FRESH
MEDIA BEING DELIVERED, OLD MEDIA
TAKEN OUT TO INCREASE LONGEVITY,
WE THOUGHT POTENTIALLY IVF TO
INCREASE THE NUMBER THAT ARE
MORE VIABLE GIVING THE WOMAN A
GREATER CHANCE OF A PREGNANCY.
EVEN IN THE INDUSTRY,
AGRICULTURAL INDUSTRY, IN VITRO
FERTILIZATION IS USED FOR THE
DAIRY AND -- I MEAN, THERE'S
JUST SO MANY NEEDS OUT THERE,
BUT ULTIMATELY, I WOULD LOVE TO
SEE THE DEVICE BENEFIT PATIENT
CONDITIONS AND TO TEST THE MOST
EFFECTIVE TREATMENTS IN THE
PLATFORM BEFORE IT ACTUALLY GOES
INTO THE PATIENT.
>> THIS HAS BEEN GREAT.
WE ARE OUT OF TIME, BUT I DO
ALSO WANT TO MAKE ONE MORE PLUG
HERE.
I THINK -- I WAS A PROFESSOR IN
THE LARGEST BIOMEDICAL
ENGINEERING DEPARTMENT IN THE
COUNTRY.
THE WOMEN STUDENTS ARE READY,
THEY ARE INVOLVED, THIS IS A
GREAT ATTRACTIVE TOOL FOR OUR
COMMUNITY TO BRING PEOPLE IN AND
TO ASK THESE QUESTIONS EARLY ON
AND TO BEGIN TO THINK ABOUT THIS
IN THE EARLY STAGES OF LEARNING.
SO THANK YOU ALL FOR BRINGING
TECHNOLOGY TO WOMEN'S HEALTH AND
THANK YOU ALL FOR THIS TIME.
[APPLAUSE]
>> THANK YOU, DR. PLATT, AND
THANK YOU, PANELISTS.
REALLY TERRIFIC PRESENTATIONS
AND DISCUSSION.
I'D LIKE TO NOW INVITE
DR. CLAYTON TO INTRODUCE OUR
NEXT SPEAKER.
>> IT'S MY PLEASURE TO INTRODUCE
DR. SUSAN MARGULIES.
SHE LEADS THE DIRECTORATE FOR
ENGINEERING AND AS YOU KNOW,
THEY HAVE A MISSION TO TRANSFORM
OUR WORLD FOR A BETTER TOMORROW
BY DRIVING DISCOVERY, INSPIRING
INNOVATION, ENRICHING EDUCATION
AND ACCELERATING ACCESS.
THE NSF'S ENGINEERING
DIRECTORATE PROVIDES OVER 40% OF
THE FEDERAL FUNDING FOR
FUNDAMENTAL RESEARCH IN
ENGINEERING AT ACADEMIC
INSTITUTIONS.
AND WE'RE THRILLED TO HAVE HER
HERE TODAY.
SHE JOINED NSF AS ASSISTANT
DIRECTOR IN AUGUST OF 2021,
AFTER LEADING THE DEPARTMENT OF
BIOMEDICAL ENGINEERING AT
GEORGIA INSTITUTE OF TECHNOLOGY
AND EMORY UNIVERSITY.
DR. MARGULIES, I DISCUSSED THIS
WITH YOU WHEN WE FIRST MET
FAIRLY RECENTLY, IS
INTERNATIONALLY RECOGNIZED FOR
PIONEERING STUDIES TO IDENTIFY
MECHANISMS UNDERLYING BRAIN
INJURIES IN CHILDREN AND
ADOLESCENTS, AND LUNG INJURIES
ASSOCIATED WITH MECHANICAL
VENTILATION, LEADING TO IMPROVED
INJURY PREVENTION DIAGNOSIS AND
TREATMENTS.
HER TRANSDISCIPLINARY SCHOLARLY
IMPACT HAS BEEN RECOGNIZED BY
HER ELECTION AS A FELLOW IN THE
AMERICAN SOCIETY SOCIETY OF MECL
ENGINEER, THE BIOMEDICAL
ENGINEERING SOCIETY, AND THE
AMERICAN INSTITUTE FOR MEDICAL
AND BIOLOGICAL ENGINEERING.
SHE IS A MEMBER OF THE NATIONAL
ACADEMY OF ENG FEARING, NATIONAL
ACADEMY OF MEDICINE AND THE
AMERICAN ACADEMY OF ARTS AND
SCIENCES.
IT'S MY PLEASURE TO INTRODUCE
DR. SUSAN MARGULIES.
>> THANK YOU.
>> ABOUT HALF OF -- UNLIKE NSF
WHERE THE DIRECTORS OF THE
INSTITUTES AND CENTERS ARE
PERMANENT FEDS, AT NSF, ABOUT
HALF OF US WHO LEAD DIRECTORATES
ARE ROTATORS.
SO I'M ON A FOUR-YEAR TERM.
I STILL HAVE MY EMORY AND
GEORGIA TECH PAYCHECKS.
I'M NO LONGER CHAIR OF THE
DEPARTMENT THAT MANU IS PART OF,
BUT I STILL RUN A LAB AND I HAVE
THE OPPORTUNITY AND TAKE TO GO
BACK TO ATLANTA ONCE A MONTH TO
DO EXPERIMENTS.
SO IT'S KIND OF AN ECLECTIC
OPPORTUNITY, BUT IT'S ALSO AN
OPPORTUNITY TO SERVE THE NATION
BY BRINGING ACTIVE RESEARCH
MINDSET TO THE NATIONAL SCIENCE
FOUNDATION.
MOST OF MY RESEARCH OVER THE
COURSE OF MY DECADES-LONG CAREER
THAT BE NIH.
SO ONE OF THE THINGS THAT I
BRING TO THE ENGINEERING
DIRECTORATE, AND I AM THE FIRST
BIOENGINEER TO LEAD THE
ENGINEERING DIRECTORATE, IS TO
ADDRESS FUNDING DEZ ERTS.
YOU WERE TALKING ABOUT A FUNDING
DESERT RELATED TO WOMEN'S HEALTH
THAT IS BROADER THAN ONE AGENCY.
BUT I WANT TO ALSO TALK ABOUT
IPT AGENCY COLLABORATION AND THE
FUNDING DEZ ERTS THAT OCCUR.
SO AT THE NATIONAL SCIENCE
FOUNDATION, WE FUND ALL
ENGINEERING, ALL SCIENCE, AND A
FUNDAMENTAL LEVEL WITH EARLY
TRANSLATION.
AS YOU'LL SEE FROM MY FIRST
SLIDE, HEALTH IS IN THE NAME OF
OUR AGENCY'S MISSION.
TO REALLY BE A BIOENGINEER AND
BIOMEDICAL ENGINEER AND IDENTIFY
FOR OUR P.I. POPULATIONS, WHEN
DO THEY GO TO NSF, WHEN DO THEY
GO TO NIH, FOR THAT IMPORTANT
FUNDING.
AND I'M PLEASED TO SHARE WITH
YOU THE OPPORTUNITY TO DECREASE
THOSE FUNDING DESERTS AND
COLLABORATE ACROSS AGENCIES.
SO I WOULD SAY THE PURPOSE OF MY
TALK IS TO ASK YOU TO HELP US
THINK ABOUT REDUCING THOSE
FUNDING DESERTS AND FIND THOSE
OPPORTUNITIES FOR SYNERGY TO
REALLY CATALYZE RESEARCH AT THE
INTERFACE THAT SERVES THE NEEDS
OF BOTH NIH AND NSF.
AND I WOULD SAY I'M DOING THIS
IN ALL ENGINEERING.
DEPARTMENT OF TRANSPORTATION HAS
NEVER REALLY HAD RELATIONSHIPS
WITH THE NATIONAL SCIENCE
FOUNDATION, BUT ALSO DOD, AND AS
WELL THE DEPARTMENT OF COMMERCE
AND THE DEPARTMENT OF ENERGY.
BIG PARTNERS FOR US TO REALLY
IDENTIFY THOSE FUNDING DESERTS
AND TO ACCELERATE THE
TRANSLATION FROM FUNDAMENTAL
RESEARCH TO AN APPLICATION
THAT'S IN THE HANDS OF THOSE IN
OUR COUNTRY AND IMPROVE THE
QUALITY OF THE LIVES FOR ALL.
IN ADDITION, THE ENGINEERING
DIRECTORATE WAS FORMED AT A
TIME, 1981, NOT UNLIKE TODAY,
WHEN THE U.S. DID NOT HAVE
INDUSTRIAL PROMINENCE GLOBALLY
AS WE ONCE DID.
SO THE ENGINEERING DIRECTORATE
WAS LAUNCHED THAT TIME TO
IDENTIFY CLOSE SYNERGIES WITH
INDUSTRY.
BOTH IN TERMS OF AREAS RESEARCH
THAT WERE SO IMPORTANT, BUT ALSO
THE ENGINEERING WORKFORCE.
SO THE OTHER PLACE THAT WE
COLLABORATE BETWEEN OUR AGENCIES
ARE THE OPPORTUNITY TO TRAIN AND
I CREASE NOT ONLY THE
EDUCATIONAL PATHWAYS BUT THE
WORKFORCE DEVELOPMENT PATHWAYS
FOR BIOENGINEERS AND BAY OWE
MEDICAL ENGINEERS.
I DO ALL ENGINEERING IN YOU MY
ROLE RIGHT NOW, BUT FOR TODAY,
THAT'S AN IMPORTANT ONE AS WELL.
WE HAVE A COLLABORATION IN
PLACE, I DECIDED AT THE VERY
BEGINNING OF MY TERM TO BROADEN
AND ENRICH OUR ADVISORY
COMMITTEE FOR THE ENGINEERING
DIRECTORATE BY ADDING BRUCE
TROMBERG TO OUR ADVISORY
COMMITTEE.
HE GOT AN INSIDE LOOK OF HOW NSF
WORKS, WHICH IS DIFFERENT THAN
HOW NIH WORKS.
AND OPPORTUNITIES THAT ARE NOT
JUST A PULL FROM NSF TO NIH IN
THIS CASE, NIBIB, BUT A PULL
FROM NIB TO NSF.
THROUGH THAT I'M GOING TO
HIGHLIGHT A FEW PARTNERSHIPS AT
THE END.
I KNOW YOU'RE GOING TO HAVE MORE
IDEAS OF OTHER WAYS THAT WE
COULD BE PARTNERING.
INCLUDING USING SOME OF THE
INNOVATIVE MECHANISMS THAT WE'VE
DEVELOPED NOW IN THREE YEARS TO
FUND BETWEEN OUR AGENCIES,
YOU'LL THINK OF OTHER ICs
WITHIN NIH WHO WE SHOULD BE
APPROACHING TO USE THESE VERY
SAME MECHANISMS.
OKAY.
I PROMISED YOU THAT THE NSF
MISSION STATEMENT INCLUDES
HEALTH AND I DUG IN DEEP.
SO THE AREA OF HEALTH THAT WE DO
OVERLAP WITH IS REALLY ANYTHING
THAT HAS TO DO WITH
DISEASE-AGNOSTIC, SO MAKING SURE
PROOF OF CONCEPT, THE ANIMAL
MODELS, YOU HAVE HUMAN STUDIES,
ALL TYPES OF AREAS WHERE WE
INTERACT, BUT IF YOU START
GETTING DOWN INTO A PARTICULAR
DISEASE THAT THIS IS GOOD FOR,
THEN IT MUST BE NIH.
AND THAT IS TO KEEP OUR AGENCY
DISTINCT.
BUT THERE'S A HUGE OVERLAP OF
SPACE WHERE OUR AGENCIES
COLLABORATE.
AND THE OPPORTUNITY TO CREATE
THAT COLLABORATION THAT IS ALSO
A BATON PASSING WHERE THE BATON
IS NOT DROPPED BETWEEN AGENCIES
IS SO IMPORTANT AND I'LL SHARE
ONE OF THOSE WITH YOU.
SO AT THE NATIONAL SCIENCE
FOUNDATION, WE REALLY FUND
CURIOSITY-DRIVEN AND
DISCOVERY-BASED EXPLORATIONS.
SO WHEN THE EQUIVALENT SECTION
OF SIGNIFICANCE AND INNOVATION
IN AN NSF GRANT, IT'S OKAY TO
SAY, WE NEED THIS, WE DON'T
UNDERSTAND HOW IT WORKS.
NOW IN THE ENGINEERING
DIRECTORATE, ALMOST EVERYTHING
THAT WE FUND HAS A USE-INSPIRED,
SOLUTION-FOCUSED INNOVATION
ASPECT TO IT, BUT THERE'S SOME
FIELDS THAT ARE REALLY
FUNDAMENTAL DISCOVERY-BASED, AND
MORE AND MORE, OUR AGENCY IS
REALLY FOCUSING ON THE POTENTIAL
USE OF SOME OF THE DISCOVERIES.
MAYBE NOT IN THE LIFETIME OF THE
INVESTIGATOR, OR THE DURATION OF
THAT GRANT, BUT TELL US HOW IT
MIGHT TRANSLATE, AND KREA ATE
THOSE OPPORTUNITIES AND AVENUES
TO HASTEN THAT TRANSLATION.
OUR MAJOR PRIORITIES ARE THE
HORIZONTALS THAT WE'VE HAD IN
OUR BUDGET FOR A WHILE.
A RESILIENT PLANET HAS DEFINITE
HEALTH EFFECTS, AND I'M TALKING
TO ENVIRONMENTAL HEALTH AND
SCIENCE TO REALLY EXAMINE HOW WE
CAN COLLABORATE THERE, BUT
RESILIENT PLANET IS SO MANY
DIFFERENT THINGS.
IT ALSO INVOLVES CLEAN ENERGY
APPROACHES, CLEAN ENERGY
TECHNOLOGY, WHICH ALSO HAS A
PUBLIC HEALTH INTERACTION.
BUT ADVANCING EMERGING
INDUSTRIES FOR NATIONAL AND
ECONOMIC SECURITY, BIOTECH IS
ONE OF THE -- BUT
BIOMANUFACTURING SITS IN THERE,
WE CAN ALSO TALK ABOUT A.I.,
WIRELESS, THESE ALL HAVE
DEVICE -- HAVE APPLICATIONS IN
HEALTH AS WELL.
THE OTHER EMERGING INDUSTRIES
ARE -- I SHOULD NOTE --
SEMICONDUCTORS, MICRO
ELECTRONICS AND QUANTUM.
ALL OF THIS WILL INTERSECTS WITH
NIH'S MISSION.
CREATING OPPORTUNITIES
EVERYWHERE, SERVING PARTS OF THE
NATION WE DON'T CURRENTLY SERVE,
AND STRENGTHENING RESEARCH
INFRASTRUCTURE AND ACCESS TO
THAT RESEARCH INFRASTRUCTURE.
OUR VALUES ARE THE VERTICALS AND
THEY'RE PART OF OUR FIVE-YEAR
PLAN THAT WE HAVE RIGHT NOW
ABOUT A STRENGTHENING THAT
DISCOVERY BASIS FOR NSF,
INSPIRING THOSE TO HAVE CAREER
PATHS IN STEM AND ADVANCING
TECHNOLOGY AND INNOVATION.
SO NSF BY THE NUMBERS, WE'RE A
$9 BILLION AGENCY.
THAT'S SMALL COMPARED TO NIH.
FLAWCIAL BUT UNLIKE NIH, WE HAVE
NO INTRAMURAL LABS, SO THAT
MEANS MOST OF OUR TAXPAYER
DOLLARS IS GOING OUT THE DOOR.
93% OF OUR DOLLARS GO OUT THE
DOOR IN FUNDING RESEARCH AND
EDUCATION-RELATED ACTIVITIES.
SO IN THE ENGINEERING
DIRECTORATE, OVER 320 DIFFERENT
INSTITUTIONS, AND THERE ARE ONLY
ABOUT 340 ENGINEERING
INSTITUTIONS.
WE DO FUND OUTSIDE OF
ENGINEERING.
YOU DON'T HAVE TO BE AN ENGINEER
TO GET ENGINEERING DIRECTORATE
FUNDING.
WHITE HOUSE PRIORITIES FOR 2025,
WHICH WERE PUBLISHED IN AUGUST
OF 2024, INTERESTINGLY WHEN YOU
HAVE AN ADMINISTRATION
TRANSITION, WE ARE STILL WAITING
FOR OUR WHITE HOUSE PRIORITIES
BECAUSE THERE WILL BE NEW PEOPLE
IN THE WHITE HOUSE COMING SOON.
SO IF YOU TAKE A LOOK AT THESE
WHITE HOUSE PRIORITIES, I WILL
TELL YOU THAT NSF EN ENGINEERING
DIRECT TEMPERATURE IS INVOLVED
IN ALL OF THEM.
THE PRIORITIES AND GOALS FOR THE
ENGINEERING DIRECTORATE ARE
REALLY TO TRANSFORM OUR WORLD
FOR A BETTER TOMORROW.
SO REALLY TO HIGHLIGHT THAT WE
NOT ONLY DO RESEARCH AND DRIVE
DISCOVERY, WE INSPIRE A LOT OF
CREATIVITY AND INNOVATION,
ENRICHING EDUCATION AND
ACCELERATING ACCESS.
SO ONE OF THE GOALS IN MY TERM
IS REALLY TO PROPEL OUR
LEADERSHIP IN ENGINEERING
INNOVATION IN AREAS OF SOCIETAL
IMPACT.
WOMEN'S HEALTH IS RIGHT IN THAT
SWEET SPOT, TO REALLY EXPAND
OPPORTUNITIES FOR PEOPLE TO
BENEFIT FROM THE RESEARCH THAT
WE FUND AS WELL AS THE EDUCATION
AND INNOVATION, BUT ALSO TO
PARTICIPATE IN.
AND THEN TO CATALYZE, PERSONAL
PARTNERSHIPS.
HOW MANY PERSONAL PARTNERSHIPS
HAVE WE KREA ATED IN THE TIME
I'VE BEEN THE ASSISTANT
DIRECTOR, WE'RE ABOUT 80
PURPOSEFUL PARTNERSHIPS.
SO THE OPPORTUNITY TO
COLLABORATE WITH THE NATIONAL
SCIENCE FOUNDATION BETWEEN NSF
AND NIH IS TRULY ONE OF THOSE,
AND A SWEET SPOT FOR THE WAY
THAT WE'VE BEEN ABLE TO
TRANSFORM.
THEY'RE ALSO WITH INDUSTRY, WITH
PHILANTHROPES, WITH OTHER
COUNTRIES AND OTHER AGENCIES
BEYOND NSF.
SO OUR AREAS OF FOCUS ARE THE
HORIZONTALS THAT YOU SEE HERE.
ALL OF THEM HAVE HEALTH
IMPLICATIONS, AND OUR VERTICALS
TRULY ARE OUR VALUES IN THE
ENGINEERING DIRECTORATE.
EQUITY, JUSTICE AND ACCESS IS
SOMETHING WE HAVEN'T REALLY
TALKED ABOUT HERE, BUT IS
CERTAIN RI A RIVER THAT RUNS
THROUGH, THE COMMENTS PEOPLE
HAVE BEEN MAKING, BUT WE ALWAYS
THINK ABOUT SUSTAINABLE AND
RESILIENT SOLUTIONS.
THESE ARE AREAS THAT IN THE
DIVISIONS ACROSS THE
ENGINEERING -- WE CO-FUND IN
THESE AREAS.
SO I LEAK TO LOOK BACKWARDS ON
INVESTMENTS TO TALK ABOUT HOW
HAVE INVESTMENTS IN THE
ENGINEERING DIRECTORATE AND EVEN
BEFORE THE ENGINEERING
DIRECTORATE ENGINEERING RESEARCH
FUNDED BY NSF LED TO IMPACT IN
MEDICINE.
SO THESE AREAS, WHETHER WE TALK
ABOUT MRNA VACCINES, DIRECTED
EVOLUTION, TISSUE ENGINEERING,
MRI, DIGITAL TWIN MODELING,
LASIK, ARTIFICIAL NEURAL
NETWORKS THAT ACTUALLY JUST WON
THE NOBEL PRIZE TODAY, THESE ARE
AREAS WHERE NSF INVESTMENT IN
ENGINEERING HAS BEEN
SIGNIFICANT.
OFTEN AT THAT EARLY STAGE,
WORKING OUT THE CHALLENGES WITH
TRANSITION FOR LATER FUNDING.
IN BIOTECHNOLOGY ACROSS THE TOP,
YOU CAN SEE INVESTMENTS THAT
HAVE BEEN MADE ACROSS THE
DECADES, AND CURRENT IMPACTS
THAT ARE STILL BENEFITS TODAY.
NOT THE EARLY ONES, BUT THE
CURRENT ONES.
AND I HELP YOU RECOGNIZE THAT
THAT IMPORTANCE OF TAKING RISK
AND INVESTING IN HIGH RISK
POTENTIALLY HIGH REWARD RESEARCH
IS SOMETHING THAT'S HARD TO DO.
PANELS OF REVIEWERS WANT TO SAY
IS THIS THE NEXT STEP?
WHAT HAVE YOU DONE TO DE-RISK
THAT FOR US TO BE ABLE TO SAY,
YES, THIS ONE IS GOING TO BE A
GREAT INVESTMENT WITH AN
EXCELLENT RETURN ON THE
INVESTMENT OF ALL OF YOUR
TAXPAYER DOLLARS THAT WE STEWARD
FOR BENEFIT BUT WE ALSO HAVE TO
TAKE RISK BECAUSE WE HAVE TO
UNDERSTAND THE IMPORTANCE THAT
CUTTING EDGE RESEARCH THAT IS
AGNOSTIC IN MY CASE FOR TODAY TO
THE DISEASE THAT IT MAY TOUCH ON
AND MAY IMPROVE, THAT CUTTING
EDGE RESEARCH IS TRULY
IMPORTANT, AND WE KEEP REAPING
THOSE BENEFITS.
THE IDEA TO BE ABLE TO GO BACK
AND THEN FUND NEW APPLICATIONS
OF OLDER INNOVATIONS IS ANOTHER
THING THAT WE MUST ACTUALLY GIVE
TIME TO, AND NOT ALL INNOVATION
STARTS AT THE FIRST SQUARE.
SOME INNOVATION ACTUALLY IS
THINKING DIFFERENTLY ABOUT
SOMETHING THAT WE HAVE ALREADY.
AND A NEW INNOVATION.
SO IF WE LOOK FORWARD TO
ENGINEERING RESEARCH HORIZONS
WITH THE EXECUTIVE ORDER ON
WOMEN'S HEALTH, AND THE MANDATED
AREAS, THESE ACTIONS ARE
PRIORITY FOR THE NATIONAL
SCIENCE FOUNDATION, AND WE'RE
PART OF THE TEAM THAT REPORTS ON
A REGULAR BASIS ABOUT WHAT WE'RE
DOING AND WE'RE QUITE COMMITTED.
THE ENDING UNEQUAL TREATMENT
REPORT, I SEE THAT CONSENSUS
REPORT THAT WE'RE GOING TO BE
TALKING ABOUT THAT NEXT.
SO IT'S SO IMPORTANT TO BE ABLE
TO DEMOCRATIZE ACCESS AND
TREATMENT.
THE NSF INVESTMENT IN WOMEN'S
HEALTH IS MODEST.
I THINK IT SHOULD BE MORE.
AND I LOOK FORWARD TODAY TO LOOK
FOR AN OPPORTUNITY TO HOW WE CAN
INCREASE IT.
WOMEN'S HEALTH IS NOT A DISEASE.
WOMEN'S HEALTH IS
DISEASE-AGNOSTIC.
SO NSF CAN BE FUNDING THIS.
AND IT WAS WITH A GREAT
EAGERNESS THAT WE HAD SEVERAL
THINGS THAT WE'RE GOING TO
HIGHLIGHT THAT ARE A RESULT OF
THAT EXECUTIVE ORDER.
OUR ENG 'NOTHERRING VISIONING
ALLIANCE THAT WAS STOOD UP TO
IDENTIFY THE FRONTIERS WHERE
ENGINEERING CAN LEAD, WHILE THE
ENGINEERING DIRECTORATE OF NSF
IS ONE OF THE TARGETS, ALL
ENGINEERING, THIS COULD BE FOR
DEPARTMENT OF ENGINEERING,
DEPARTMENT OF ENERGY, JUST
ENGINEERING, WHERE SHOULD WE BE
LEADING?
AND THEY IDENTIFY AND CATALYZE
AND BRING TOGETHER INDUSTRY,
INVESTORS, ACADEMIA, AS WELL AS
OTHER AGENCIES TO THINK ABOUT
PRIORITIES FOR THE NATION.
DON'T THINK ABOUT THE NEXT FIVE
YEARS.
WE'VE ACTUALLY PLANNED OUR
BUDGETS, WE'VE SUBMITTED BUDGETS
FOR 2026.
DON'T TELL US WHAT WE SHOULD BE
DOING IN FIVE YEARS, WE NEED TO
KNOW WHAT TO BE DOING IN 20
YEARS.
WE NEED TO KNOW HOW TO PLAN TO
GET THERE AND WE HAVE THOSE
VOICES AT THE TABLE.
IN JUNE THERE WAS A VISIONING
EVENT, TRANSFORMING WOMEN'S
HEALTH, WELL ATTENDED, I
ATTENDED AS WELL.
THE SCOPE WAS GOING BEYOND THE
REPRODUCTIVE -- PRENAY IT WILL
TO PUBERTY REPRODUCTIVE YEARS,
AND THEN REPRODUCTIVE YEARS NOT
RELATED TO PREGNANCY
IMPORTANTLY, AND THEN PRE,
PERIAND POST-MENOPAUSAL, REALLY
THINKING ABOUT TECHNOLOGY.
SO THIS IS ENGINEERING FORWARD.
THAT CONFERENCE WAS IN JUNE, THE
REPORT, MICHELLE TELLS ME, WAS
SUBMITTED TORE REVIEW AND
EVALUATION THE SAME NASEM
REPORTS GO OUT FOR REVIEW, THESE
DO AS WELL, AND THAT REPORT
EXPECT THAT IT WILL BE RELEASED
THIS FALL.
MICHELLE HOPES IT WILL BE
RELEASED IN TWO WEEKS.
I'M NOT SURE.
IN ADDITION, SO THAT WAS JUNE,
IN AUGUST, WE FUNDED ELEVATEHER,
ENGINEERING SOLUTIONS FOR
WOMEN'S HEALTH.
YOU CAN SEE THE TOPICS HERE
COMPLEMENT THE ONES OF THE ONE
WE HAD -- THE CONFERENCE
EARLIER.
WE EXPECT THAT WHAT COMES FROM
THIS REPORT ARE SUGGESTIONS FOR
WHERE WE SHOULD HAVE CALLS FOR
PROPOSALS.
SO I WANT TO COMMENT ALSO ABOUT
EARLIER IN SEPTEMBER, USING A.I.
TO BETTER UNDERSTAND MENOPAUSE.
THAT WAS ACTUALLY ANOTHER THAT
WE OFTEN BEGIN WITH HAVING A
CONFERENCE TO STIMULATE
COMMUNITIES TO COME TOGETHER,
THAT'S THAT PAIR FINDING BUT
THEN IT STIMULATES US, THE NSF,
TO UNDERSTAND WHERE WE NEED TO
FIND AND FUND THOSE
OPPORTUNITIES.
WE SUBMITTED -- WE PUBLISHED AN
NSF FUNDING OPPORTUNITY CALLED A
DEAR COLLEAGUE LEDDER OR DCL.
HIGHLIGHTING THAT NSF FUNDS IN
THIS AREA.
AND WE HAVE HAD PROPOSALS, THIS
CAME OUT IN THE SPRING, AND IT'S
HIGHLIGHTED THE AREAS IN WHICH
THOSE WHO SLY OR CONFUSED ABOUT
WHAT NSF MIGHT FUND IN THE AREA
OF WOMEN'S HEALTH REALLY BE
SPECIFIC, AND YOU CAN SEE THEM
LISTED HERE.
THESE ARE AREAS THAT ARE
SOMETIMES NOT FUNDED AT NIH.
ESPECIALLY THE DEVELOPMENT OF
MODELS NOT OFTEN FUNDED AT NIH.
YOU CAN USE THE MODEL FOR
SOMETHING, BUT AT NSF, WE FUND
THE DEVELOPMENT OF THOSE MODELS
BUT YOU CAN SEE MANY OTHER
THINGS THAT YOU MIGHT HAVE
THOUGHT, OH, WOW, I DIDN'T EVEN
KNOW THAT THE NATIONAL SCIENCE
FOUNDATION FUNDS THESE TYPES OF
AREAS OF RESEARCH IN WOMEN'S
HEALTH.
THE CORE ENGINEERING PROGRAMS
THAT ARE PARTICIPATING ARE SHOWN
HEE AND I JUST HIGHLIGHTED ONE
AWARD, A CAREER AWARD.
THIS IS AN EARLY STAGE
INVESTIGATOR AWARD IN BIOME CAN
NEXT AND MECHANOBIOLOGY OF
UTERINE GROWTH AND REMODELING.
SO THOSE ARE FUNDING ALREADY AT
THE NATIONAL SCIENCE FOUNDATION.
WE HAVE LARGE INVESTMENTS, OUR
ENGINEERING RESOURCE CENTERS.
YOU CAN SEE THOSE TOUCHING ON
THE AREAS THAT COULD GO IN THE
DIRECTION OF WOMEN'S HEALTH BUT
ARE NOT LIMITED, AND I WANT TO
HIGHLIGHT ONE MECHANISM THAT WAS
OF GREAT INTEREST TO NIBIB, THE
INDUSTRY UNIVERSITY COOPERATIVE
RESEARCH CENTERS.
THIS IS WHERE THERE'S A MODEST
INVESTMENT BY THE NSF, THEED ARE
LED THROUGH THE ENGINEERING
DIRECTORATE BUT NOT LIMITED TO
ENGINEERING.
AND YOU CAN SEE THESE TOPICS.
NOW IMAGINE EACH P.I. MUST BRING
IN MEMBERS WHO ARE PAYING
MEMBER, 50 TO $75,000 A YEAR TO
SIT AT THE TABLE OF
PREDECISIONAL RESEARCH AND
INFLUENCE THE P.I.'S PROPOSALS
THAT THEY'RE PUTTING IN FOR THIS
AWARD, WHICH IS COMBINED NSF AND
MEMBER FUNDING, TO FUND.
NOW, NIH COULD BE AT THE TABLE
AS A MEMBER AS WELL, AND THEY
CAN INFLUENCE THE DIRECTION THAT
THESE IUCRCs ARE TAKING IN
THEIR PILOT.
WHAT ENDS UP HAPPENING IS THOSE
MEMBERS AT THE TABLE, INDUSTRY,
OTHER -- INFLUENCE THOSE PILOTS
AND THEN LEAD TO FOLLOW-ON
FUNDING DIRECTLY TO P.I. OR THAT
OTHER AGENCY WHERE THEY SAY WE
INVITE YOU TO, PLEASE, COME, WE
HAVE FUNDING OPPORTUNITIES, AND
DE-RISKING IT FOR THOSE FUNDING
AGENCIES.
I WANT TO HIGHLIGHT ALSO THE
PROGRAM WE'VE HAD FOR A NUMBER
OF YEARS WITH A NUMB WE ARE OF
DIFFERENT ICs AT NIH IN SMART
HEALTH AND BIOMEDICAL RESEARCH
IN THE AREA OF ARTIFICIAL
INTELLIGENCE AND WHEN YOU TAKE A
LOOK AT WHAT THAT IS, I JUST
WANT TO HIGHLIGHT THIS ONE AWARD
THAT WE MADE IN PERSONALIZED
WATCH BASED FALL DETECTION, SO
CLEARLY IN THE AREA OF WOMEN'S
HEALTH, SOMEONE WITH
OSTEOPOROSIS, WHEN I WAS TOLD
THAT I HAVE A 30% CHANCE OF
FRACTURE WITH A FALL, I
IMMEDIATELY CHANGED MY BEHAVIOR,
I NEVER WALK AND LOOK AT MY
PHONE AT THE SAME TIME, BUT
WOULDN'T IT BE GREAT TO BE ABLE
TO HAVE SOME TECHNOLOGY THAT
REALLY COULD, IN REALTIME,
ACTUALLY INTERVENE WITH
BEHAVIORS.
AND SO THIS IS ABOUT NOVEL
METHODS TO INTUITIVELY INTEL
INTELLIGENTLY CONNECT, ANALYZE
AND DETERMINE DATA IN REALTIME.
WE ALSO HAVE SUPPORT FOR WOMEN'S
HEALTH IN ENGINEERING RESEARCH
AND I'M JUST HIGHLIGHTING A
COUPLE.
MOST OF WHAT WE FUND AT THE
NATIONAL SCIENCE FOUNDATION IS
UNSOLICITED.
THERE IS NO SPECIAL
SOLICITATION.
THAT DEAR COLLEAGUE LETTER IN
WOMEN'S HEALTH IS JUST TO POINT
TO THE MANY PROGRAMS THAT ARE
WAITING FOR YOUR APPLICATION.
RATHER THAN A LIMITED CALL.
AND WHAT HAS RESULTED JUST
WITHOUT THAT DCL, THE ONE ON THE
LEFT IS AN AWARD THAT WAS MADE
IN 2020 AND THE ONE ON THE RIGHT
IS ONE IN 2018, I HAVE THIS OLD
ONE ON THERE FOR A REASON,
BECAUSE IT'S STILL QUITE ACTIVE,
CHARACTERIZING THE INTERPLAY
BETWEEN THE UTERUS, CERVIX,
VAGINA, IN VIVO AND EX VIVO
BECAUSE AS SOMEONE SAID, IT'S A
COMPLEX STRUCTURE, AND THEY
ACTUALLY INFLUENCE EACH OTHER IN
THE BIOMECHANICS.
AND THAT WAS SO IMPORTANT TO
FUND THAT.
THE ONE ON THE RIGHT IS VERY
COOL.
I GOT A CHANCE TO SEE AT ROCKET
LAUNCH WITH PAYLOAD GOING UP TO
THE INTERNATIONAL SPACE STATION.
THIS PARTICULAR ONE IS ONE OF
THE ONES THAT WENT UP.
THIS IS COFUNDED BETWEEN NSF AND
NASA AND CAS IS WHICH ACTUALLY
PREPARES THE EXPERIMENTS TO BE
DONE NOT BY THE INVESTIGATORS
BUT BY THE ASTRONAUTS IN SPACE.
SO THERE ARE TWO TOPICAL AREAS
THAT WE FUND.
ONE IS ABOUT TRANSPORT MEDIATED
EVENTS.
VERY INTERESTING THINGS RELATED
TO WILDFIRES, SEDIMENTATION, AND
ALSO ADVANCED MANUFACTURING THAT
WE COULD BE DOING IN SPACE.
IN ADDITION WE DO TISSUE
ENGINEER.
THIS ONE ON SARCOMERES IS REALLY
ASKING THREE TYPES OF QUESTIONS.
THE BASIC QUESTION IS, IS THE
MUSCLE LOSS, THE SARCOMERE LOSS
THAT HAPPENS IN SPACE THE SAME
AS WHAT HAPPENS IN AGING?
AND IF SO, CAN WE USE SPACE AS
THE LABORATORY TO TEST NEW DRUG
INTERVENTIONS AND TREATMENTS?
NOW JUST MONDAY I MET WITH SPACE
FORCE.
THEY ACTUALLY CARE ABOUT THEIR
SPACE FORCE IN SPACE TO THEY
ACTUALLY CARE ABOUT IMPROVING
LIFE IN SPACE AS WELL, SO THAT'S
WHY I INCLUDED IT HERE.
WE GO TO ALL ENDS OF THE WORLD
AND BEYOND TO REALLY THINK ABOUT
WOMEN'S HEALTH.
THIS IS THE LAST PROJECT THAT
I'M GOING TO PRESENT, WHICH IS
ONE BY AN INVESTIGATOR AT
HOPKINS, AND HER WORK IS RELATED
TO THE FACT THAT ULTRASOUND
NEEDS INNOVATION TO BE ABLE TO
BE USED IN PEOPLE OF COLOR.
THE SKIN PENETRATION SHE'S
INNOVATING IN THIS AREA HAS
MULTIPLE PATENTS AND SEVERAL
STARTUPS TO REALLY CHANGE THE
ULTRASOUND TO BE ABLE TO HAVE
ITS ACCURACY AND SKIN OF ALL
COLORS.
SO I'D LIKE TO JUST TALK A
LITTLE BIT BECAUSE IT'S NOT ONLY
RESEARCH, WE'VE ALREADY
HIGHLIGHTED HOW CAN WE GET MORE
PEOPLE ENGAGED IN THIS AREA.
SO IN THE AREA OF WORKFORCE
DEVELOPMENT AND ENGINEERING
EDUCATION, WE HAVE ONE THAT IS
WITH THE LIMELSON FOUNDATION.
IT'S NOT ON THIS SLIDE.
THEY REALLY WANTED TO FUND
EDUCATION IN CURRICULUM TO
INCLUDE SUSTAINABILITY AND
RESILIENCE IN ENGINEERING
CURRICULUM.
IF YOU HAVE THE IDEA OF WHO WE
MIGHT APPROACH, PHILANTHROPIC
ORGANIZATION WHO THIPTION WE
NEED TO INFUSE IN ENGINEERING
EDUCATION THE OPPORTUNITIES --
BEYOND THE WOMEN WHO WANT TO BE
GRADUATE STUDENTS IN YOUR LAB,
MICHELLE, BUT TO BE ABLE TO
INFUSE EARLY ON THE EXCITEMENT
IN WOMEN'S HEALTH IN AN
UNDERGRADUATE CURRICULA, WE STAY
READY WITH A MECHANISM THAT
WOULD MIMIC WHAT WE'RE ALREADY
DOING WITH THE FOUNDATION.
SO I WOULD LOVE TO KNOW WHAT
THOSE POTENTIAL NON-PROFITS
MIGHT BE.
BUT WE ALSO ARE REVOLUTIONIZING
DEPARTMENTS, AND KREA ATING
THOSE EXCITING SPIRITS FOR
UNDERGRADUATES.
I DON'T KNOW ABOUT YOU BUT I GOT
HOOKED GOING INTO ACADEMIA THE
SUMMER OF MY FRESHMAN YEAR.
LET'S TALK ABOUT HOW WE
CULTIVATE PARTNERSHIPS.
WE COMBED 10 YEARS OF
PUBLICATIONS, PUBLIC -- ACCESS
PUPUBLICATIONS FOR ALL OF THE
PAPERS THAT CITED NIH AND NSF.
IN PARTICULAR, THE ENGINEERING
DIRECTORATE.
AND WE WANTED TO KNOW, THESE ARE
PEOPLE WHO ARE BRIDGING THAT
CHASM THEMSELVES.
THEY'RE CITING NIH GRANTS AND
NSF ENGINEERING AWARDS.
HOW MANY ARE THERE?
AND HOW CAN WE -- AND WHERE ARE
THEY SEEKING FUNDING AND GAINING
THAT FUNDING AT NIH, AND HOW CAN
WE AT NSF CREATE THOSE BRIDGES
OF EFFICIENCY SO THAT YOU DON'T
HAVE TO HAVE NECESSARILY TWO
SEPARATE GRANTS.
SO WHAT YOU SEE ON THE LEFT IS
THE NUMBER OF PUBLICATIONS WHERE
PEOPLE ARE CITING BOTH NIH AND
NSF IS INCREASING, A LOT.
WHAT YOU SEE AT THE BOTTOM IS
THE DATA THAT I PRESENTED TO
BEUS IN A ONE-ON-ONE.
LOOK, IT'S NOT GOING UP AND DOWN
SO THE FRACTION OF FUNDING THAT
IS COMING FROM NIBIB IN THESE
AREAS OF SYNERGY, THE FRACTION
IS DECREASING BECAUSE THE NUMBER
IS GOING UP.
BUT IF YOU LOOK AT -- YOU SEE
ALL THE DIFFERENT ICs AND SEE
THAT NIBIB IS SECOND.
SO NIGMS, SO MY QUESTION TO YOU
IS, HOW CAN WE SYNERGIZE EVEN
MORE, PARTICULARLY IN THE AREA
OF WOMEN'S HEALTH?
SO I'M GOING TO SHARE WITH YOU
THREE MECHANISMS THAT WE'VE
CREATED IN PARTNERSHIP BETWEEN
NIBIB AND THE ENGINEERING
DIRECTORATE, BUT ON OUR SIDE,
IT'S ALL OF NSF.
THIS ONE IS IN SIN THEY TECH SYC
BIOLOGY.
I BRING THIS UP THAT -- I PUT AT
THE BOTTOM, ONE PROJECT, TWO
PHASES, TWO AGENCY, ONE PROPOSAL
SUBMISSION.
YOU TAKE THOSE PEOPLE WHO HAVE
BEEN PUBLISHING, THEY KNOW HOW
TO WRITE AN NSF GRANT
SUCCESSFULLY, AND THEY KNOW HOW
TO WRITE A SUCCESSFUL NIH GRANT.
WHY DON'T WE COMBINE IT.
SO WE HAVE THIS MECHANISM, WHICH
IS IN SYNTHETIC BIOLOGY.
THE PROPOSALS ARE DELIBERATELY
DUE DECEMBER 4TH BECAUSE WE KNOW
THAT THE MECHANISMS ARE CHANGING
OVER SECTIONS AND REVIEW
CRITERIA.
SO IT HAS TO MEET THE NEW
CRITERIA.
THEY'LL GO INTO EFFECT IN
JANUARY, BUT WE THOUGHT THIS WAS
FINE.
ONE PROJECT HAS AN NSF PHASE,
TWO YEARS, MILESTONES, AND THEN
AN NIH PHASE.
AND THE BUDGET GOES UP TO THE
NIH PHASE.
IT WILL BE NIBIB.
THAT ONE PROJECT IS DESCRIBING
THE FULL FOUR YEARS.
THE BUDGET, ALL FOUR YEARS.
IT SUBMITTED, IT HAS TO HAVE ALL
THE FORM OF AN NIH GRANT AND IT
HAS TO HAVE ALL THE FORM OF AN
NSF GRANT.
WHEN I SAY THAT WITHIN MY
AGENCY, PEOPLE SAY WHO WOULD
WANT TO WRITE ONE LIKE THAT?
AND I SAID THE PEOPLE ARE
ALREADY WRITING THEM LAKE THAT
AND THEY WOULD LOVE TO BE ABLE
TO SHARE ALL OF IT AT THE SAME
TIME.
THE REVIEWERS ARE AT NSF, WITH
NIH THERE, ALL OF THE SAME
CRITERIA THAT ARE USED AT NIH
WILL BE USED, AS WELL AS ALL OF
THOSE FOR NSF.
WHO WOULD SERVE ON A PANEL AND
WRITE A REVIEW LIKE THAT?
ALL THE PEOPLE WHO ARE ALREADY
SERVING ON PANELS FOR BOTH OF
OUR AGENCIES.
SO I SEE THIS AS SUCH A WIN FOR
OUR AGENCIES.
IT'S FINALLY SOLVING THAT DESERT
OF FUNDING.
BECAUSE IF YOU ACCOMPLISH THOSE
HIGH RISK GOALS, IT THEN
TRANSLATES DIRECTLY TO NIH.
AND GUESS WHAT?
NO MONEY FROM NIH COMES TO NSF.
INSTEAD, THE FIRST TWO YEARS,
NIH WILL PUT IN A DOLLAR.
WHY?
THEY GET ANNUAL REPORTS FOR
THOSE FIRST TWO YEARS WHERE
THEY'RE NOT FUNDING THE BULK OF
IT, AND THE LAST TWO YEARS NSF
IS PUTTING IN JUST A DOLLAR.
SO WE'RE EXCITED ABOUT THIS AND
WE SEE THE POTENTIAL
APPLICATION.
THIS IS ONE THAT ALSO HAS AN
APPLICATION IN PUBLIC HEALTH.
REMEMBER I TALKED ABOUT THE
INDUSTRY UNIVERSITY COOPERATIVE
RESEARCH CENTERS?
THIS IS ONE THAT WE ARE GOING TO
DO BETWEEN NIBIB AND NSF AND THE
FDA.
THE TOPIC, PHANTOMS, STANDARDIZE
THEM, TOWARDS UNIFORM ADOPTION.
LET'S DO THIS FOR WOMEN'S
HEALTH.
WE COULD BE DOING THIS AS WELL.
THIS IS AN NSF MECHANISM THAT'S
NOW WHERE NIH IS COMING IN, AND
THE NIH MONEY WILL FLOW TO NSF
BECAUSE IT'S A MECHANISM THAT WE
HAVE.
SO IN CLOSING, THERE'S SO MANY
URGENT ISSUES THAT ARE AFFECTING
PUBLIC HEALTH AND WOMEN'S HEALTH
IN PARTICULAR.
AND I REALLY LOOK FORWARD TO
THOSE OPPORTUNITIES TO REALLY
MAKE A DIFFERENCE.
THE LAST ONE I'LL SHOW AT THE
TOP, IN THE ENGINEERING
DIRECTORATE, WE HAVE DISASTER
RESILIENCE RESEARCH.
WE HAVE TEST BEDS WITH SHAKE
TABLES, WHERE 10 STORY BUILDINGS
CAN GO ON IT.
WE ALSO HAVE PEOPLE THAT ARE
PREPARED TO GO LITERALLY
TOMORROW TO DISASTER SITE, AND
OUR RELATIONSHIP WITH NIH HAS
ALLOWED US TO, THROUGH NIH
FUNDING, TO FUND PEOPLE TO BE
TRAINED TO GET THE HUMAN -- THE
EPHEMERAL HUMAN DATA AND
DISASTER SITE SO THAT NIH CAN
HAVE THAT IMPORTANT DATA.
OH SO OUR PEOPLE ARE NOT
PREPARED TO GATHER THAT DATA
NORMALLY.
THEY'RE LOOKING AT OTHER
ASPECTS.
IT COULD BE NATURAL DISASTERS,
BUT WE NEED THE PEOPLE DATA TOO.
AND IF WE FOCUS ON THE PEOPLE
DATA FROM WOMEN AND MEN AND MAKE
IT A SEX-BASED DISTINCTION, WE
MAY GET SOME VERY INTERESTING
INFORMATION ABOUT WOMEN'S HEALTH
IN THE FACE OF DISASTERS.
SO I LOOK FORWARD TO OUR
COLLABORATION.
>> THANK YOU SO VERY MUCH.
WE HAVE TIME FOR ONE OR TWO
QUESTIONS.
FROM MEMBERS.
>> THAT WAS SUCH AN INCREDIBLE
PRESENTATION, SUSAN.
YOU HIGHLIGHTED SO MANY CRITICAL
ISSUES NOT JUST FOR OUR NATION,
FOR OUR WORLD.
YOU HIGHLIGHTED, FOR EXAMPLE,
THE MUSCLE CHANGES THAT ARE SEEN
IN SPACE, THERE ARE KNOWN SEX
DIFFERENCES IN SPACE TRAVEL'S IT
EFFECT ON MEN AND WOMEN, THERE
ARE OCULAR EFFECTS AS WELL, THAT
ARE REALLY UNIQUE, NOT SEEN
ANYWHERE ELSE SO THAT'S
FASCINATING SCIENCE.
BUT I THINK WHAT YOU CA CHALLEND
US TO DO WAS TO BE CREATIVE.
YOUR AND NSF'S VISION FOR
PARTNERSHIP.
WE TALK ABOUT INTERDISCIPLINARY
RESEARCH, WE KNOW THE HO POWERF
BRINGING DISCIPLINES TOGETHER.
BUT I WONDER IF YOU MIGHT
COMMENT ON OVERCOMING THOSE
BARRIERS TO US WORKING TOGETHER,
HOW YOU SEE.
CLEARLY, YOU'VE DESIGNED THESE
MECHANISMS, BUT WE DO APPROACH
THINGS DIFFERENTLY.
SIMPLIFY REVIEW FRAMEWORK IS
GOING INTO EFFECT IN JANUARY.
HOPEFULLY THAT WILL MAKE THINGS
MORE STREAMLINED AND EASIER FOR
EVERYONE, BUT WHAT ARE YOUR
THOUGHTS FROM YOUR VANTAGE POINT
FROM THE NSF SIDE?
>> SO WE'VE HAD MANY YEARS OF
COLLABORATIONS.
THEY TEND TO BE ONE PROGRAM
DIRECTOR AND ONE PROGRAM
DIRECTOR WHO FOUND EACH OTHER AT
A NATIONAL MEETING OR KNEW EACH
OTHER AND THEY DEVELOPED
SOMETHING ON A PARTICULAR TOPIC,
AND IT HAS A LIFE OF MAYBE JUST
A COUPLE YEARS.
IT'S IMPRESSIVE WHEN IT'S LONGER
THAN A COUPLE YEARS BUT IT'S
NOT -- THAT WOULD BE THE TAIL.
SO THESE MECHANISMS THAT ARE NOW
AT THE LEVEL OF LIKE IC
DIRECTOR.
AND I'M CONTENT WITH THE FACT
THAT AT NIH, IT'S IC BY IC.
SO BRUCE AND I HAVE TALKED ABOUT
SHOULD THERE BE A PRESENTATION
AT ONE OF THE GATHERINGS WHERE
YOU ALL GET TOGETHER AND THIS IS
POTENTIAL, AND THERE CAN BE AN
OPPORTUNITY TO THINK ABOUT A
TOPIC THAT SUITS OTHERS.
WHEN YOU TALK ABOUT THE ONE
PROPOSAL, ONE SUBMISSION, WE
EVEN HAVE TO TALK ABOUT IF
THERE'S A FREEDOM OF INFORMATION
REQUEST, SO IT GOT DOWN TO THE
OFFICE OF GENERAL COUNCIL IN
EACH OF OUR AGENCIES.
WE REALLY WORKED THINGS OUT ON
HOW THIS WOULD LOOK.
FOR AS MANY DIFFERENT DETAILS AS
POSSIBLE.
SO I VIEW THESE AS BLOCKS ON
WHICH WE CAN BUILD, RATHER THAN
A TENUOUS STRAIN THAT CONNECTS
OUR TWO AGENCIES TOGETHER.
SO OPPORTUNITIES TO GET IN FRONT
OF THOSE WHO ARE THE DECISION
MAKERS, WHO SAY WE'VE GOT TO USE
THIS BECAUSE THIS ALLOWS US TO
MEET THE NEEDS OF OUR
CONSTITUENCIES MORE THAN WE ARE
ABLE TO DO NOW, THAT'S WHAT I
LOOK TO AS AN OPPORTUNITY.
YOU KNOW YOUR AGENCY, AND I
WOULD BE DELIGHTED TO USE
WHATEVER MODALITIES YOU THINK
WOULD BE MOST CONVINCING TO HAVE
LOWERED THE BARRIERS AND NOW
WE'RE AT ADOPTION.
SO I WOULD LOOK FORWARD TO
HEARING, SO WHICH ARE THE ICs
WITH THE MOST WOMEN'S HEALTH
RESEARCH, BECAUSE THAT WOULD BE
THE ONES THAT WE WOULD GO TO
FIRST, RIGHT?
YEAH.
>> THAT WAS A MUCH LONGER ANSWER
THAN I'M GOING TO GIVE YOU IN
TIME TODAY.
SO ANYWAY, BUT WE WILL FOLLOW UP
WITH YOU BECAUSE I THINK IT'S
JUST AN EXCITING OPPORTUNITY.
I'M GOING TO GIVE ALL OF YOU A
COUPLE, THREE MINUTES TO STAND
UP AND STRETCH, AND THEN -- SO
THANK YOU VERY MUCH ONCE AGAIN,
SUSAN.
IT WAS REALLY TERRIFIC HAVING
YOU HERE.
SO WE HAVE A 2 TO 3-MINUTE BREAK
AND WE'RE GOING TO START AGAIN.
IT'S MY DISTINCT PLEASURE TO
INTRODUCE DR. EVE HIGGINBOTHAM.
DR. HI HIGGINBOTHAM IS THE FORMR
VICE DEAN FOR DIVERSITY,
INCLUSION AND EQUITY AT THE
UNIVERSITY OF PENNSYLVANIA.
SHE'S ALSO A SENIOR FELLOW AT
THE LEONARD DAVIS INSTITUTE FOR
HEALTH ECONOMICS AND PROFESSOR
OF OPHTHALMOLOGY AT THE SHEA EYE
INSTITUTE.
SHE'S A GLAUCOMA SPECIALIST AND
IS ACTIVE IN SCHOLARSHIP RELATED
TO GLAUCOMA, OCULAR
PHARMACOLOGY, HEALTH POLICY,
HEALTH EQUITY AND ORGANIZATIONAL
CULTURE.
DR. HIGGINBOTHAM HAS SERVED AS
PRESIDENT OF THE ALPHA OMEGA
ALPHA HONOR SOCIETY AND WAS A
PAST MEMBER OF THE HARVARD BOARD
OF OVERSEERS AND THE MIT
CORPORATION.
SHE CURRENTLY SERVES ON THE TWO
VISITING COMMITTEES AT MIT, THE
INSTITUTE OF MEDICAL ENGINEERING
AND SCIENCE AND UNDERGRADUATE
AND GRADUATE STUDENT LIFE, AND
SERVES AS A BOARD OF DIRECTORS
ON SEVERAL OTHER ORGANIZATIONS.
IN ADDITION, SHE CURRENTLY
SERVES AS ASSOCIATE EDITOR ON
THE EDITORIAL BOARD OF THE
AMERICAN JOURNAL OF
OPHTHALMOLOGY.
IT IS ENGINEER DAY, AND
DR. HIGGINBOTHAM RECEIVED HER SB
AND SM DEGREES IN CHEMICAL
ENGINEERING AT MIT, AND HER
MEDICAL DEGREE AT HARVARD
UNIVERSITY, COMPLETING
OPHTHALMOLOGY RESIDENCY AT
LOUISIANA EYE CENTER.
SHE ALSO RECEIVED A MASTER'S OF
LAW DI GR DEGREE FROM THE
UNIVERSITY OF PENNSYLVANIA,
KERRY LAW SCHOOL.
SHE HAS BEEN A MEMBER OF THE
NATIONAL ACADEMY OF MEDICINE
SINCE 2000 AND SHE HAS CHAIRED
MANY GROUPS RELATED TO HER
NATIONAL ACADEMY WORK, MOST
RECENTLY THE IMPACT OF COVID-19
ON THE CAREERS OF WOMEN IN
ACADEMIC SCIENCES, ENGINEERING
AN MEDICINE.
IT IS MY HONOR TO INTRODUCE
SOMEONE WHO I'VE LOOKED UP TO IN
HER LEAD ARE SHIP POSITIONS IN
OPHTHALMOLOGY FOR MANY, MANY
YEARS, A PERSON WHO BRINGS
SCHOLARSHIP TO EVERYTHING SHE
DOES, AN EQUITABLE APPROACH AND
INCREDIBLY ALWAYS COMMITTED TO
EVIDENCE, EVIDENCE, WHERE'S THE
DATA, DR. EVE HIGGINBOTHAM.
>> THANK YOU, DR. CLAYTON.
I AM SO HAPPY TO BE HERE, AND
NOW THAT YOU RECEIVED THE COPIES
OF THE REPORT, YOU KNOW HOW
IMPOSSIBLE IT'S GOING TO BE FOR
ME TO DO THIS IN 20 TO 25
MINUTES, BUT I'LL DO MY BEST.
IT'S NEARLY 600 PAGES.
AND SO WITH THAT, I'LL JUST
START AND REALLY RECOGNIZE THAT
IT WAS A COMMITTEE THAT PULLED
THIS TOGETHER, NA SEMI
COMMITTEE, AND OUR TITLE WAS
FRAMEWORK FOR THE CONSIDERATION
OF CHRONIC DEBILITATING
CONDITIONS IN WOMEN.
CERTAINLY I'D LIKE TO THANK DRS.
CLAYTON AND WANG FOR THE
OPPORTUNITY TO PRESENT A SUMMARY
OF OUR WORK, WHICH COVERED A
YEAR AND A HALF OF EFFORT.
I WILL HIGHLIGHT THE STUDY'S
MAIN FINDINGS, CONFUSIONS, AND
RECOMMENDCONCLUSIONS ANDRECOMMEE
RESEARCH AGENDA WITH THE HOPE
THIS WILL INDEED HELP TO ADVANCE
RESEARCH ON CHRONIC CONDITIONS
IN WOMEN WITH THE OVERARCHING
GOAL OF IMPROVING THE HEALTH AND
QUALITY OF LIFE OF ALL WOMEN.
I WOULD LIKE TO FIRST THANK OUR
SPONSOR, IF WE CAN GET TO THE
NEXT SLIDE.
IT'S NOT ADVANCING.
I'D LIKE TO THANK OUR SPONSOR,
THE NATIONAL INSTITUTES OF
HEALTH, THE OFFICE OF RESEARCH
ON WOMEN'S HEALTH FOR THEIR
FINANCIAL SUPPORT FOR THIS
PROJECT, PARTICULARLY
DR. CLAYTON AND HER COLLEAGUES.
I ALSO WOULD LIKE TO ACKNOWLEDGE
THE MEMBERS OF OUR COMMITTEE,
ONE OF WHOM IS SITTING RIGHT
HERE AMONG YOU AS A MEMBER OF
THE ADVISORY COMMITTEE,
DR. ARNOLD.
THE COMMITTEE WAS CO CONVENED BY
THE NATIONAL ACADEMIES OF
SCIENCE, ENGINEERING AND
MEDICINE AND REPRESENT A RICH
DIVERSITY OF DISCIPLINES,
INCLUDING CLINICIANS, BASIC
SCIENTISTS,
CLINICIAN-SCIENTISTS, AND
EPIDEMIOLOGISTS, AND THE
BIOSKETCHES NOT ONLY DO WE HAVE
THE HARD COPY AVAILABLE, BUT YOU
CAN ACTUALLY ACCESS THE ENTIRE
REPORT ONLINE AS WELL.
AND THAT'S WHERE YOU'LL FIND ALL
THE BIOSKETCHES.
SO THE STATEMENT OF TASK IS
ALWAYS THE NORTH STAR FOR EVERY
NA SEMI REPORT.
AND OUR STATEMENT OF TASK ASKS
US TO DESCRIBE THE CURRENT
EVIDENCE AND GAPS IN THE SCIENCE
ON CHRONIC CONDITIONS IN WOMEN,
INCLUDING A REVIEW OF THE
LITERATURE, THE EPIDEMIOLOGY OF
CHRONIC CONDITIONS, DESCRIBE HOW
CHRONIC CONDITIONS IN WOMEN ARE
INFLUENCED BY FACTORS SUCH AS
MENOPAUSE, AGE-RELATED SKELETAL
DYSFUNCTION AND FRAILTY,
PREVENTION, DIAGNOSIS AND
TREATMENT TO FEMALE-SPECIFIC
GYNECOLOGIC CONDITIONS, AND WE
WERE ASKED TO DESCRIBE HOW THE
SOCIAL DETERMINANTS OF HEALTH
INFLUENCE THESE CONDITIONS.
WE WERE ALSO ASKED TO PROPOSE A
RESEARCH AGENDA, WHICH IS
PRESENTED IN THE SUMMARY AND
LAST CHAPTER OF THE REPORT.
SO I'M ALSO GOING TO BE GIVING
YOU IDEAS OF WHERE YOU CAN FIND
SOME OF THIS CONTENT.
THIS STATEMENT OF TASK SET THE
STAGE FOR OUR DISCUSSION.
WE CONSIDER THE NIH'S OFFICE OF
RESEARCH ON WOMEN'S HEALTH
FRAMEWORK, WHICH INCLUDES
44 CHRONIC CONDITIONS.
WE ALSO TOOK INTO ACCOUNT LIVED
EXPERIENCES OF WOMEN WITH
CHRONIC CONDITIONS.
WE ALSO CONSIDERED CONDITIONS
SUCH AS SUBSTANCE USE DISORDER
AND HIV, WHICH WERE ALSO
INCLUDED BECAUSE THEY IMPACT
WOMEN DIFFERENTLY.
AS A RESULT OF THIS PROCESS, WE
SELECTED THE FOLLOWING
CONDITIONS TO REVIEW IN THIS
REPORT.
THIS CREATED A BASIS FOR
IDENTIFYING RESEARCH GAPS AND
ULTIMATELY A RESEARCH PLAN.
THE CONDITIONS THAT YOU SEE
LISTED IN YELLOW ARE THOSE THAT
WERE ASH TICK LATED EXPLICITLY
IN THE STATEMENT OF TASK.
OF COURSE WE ADDED ADDITIONAL
CONDITIONS, MANY OF WHICH WE
HAVE ALREADY TALKED ABOUT TODAY.
THE COMMITTEE WAS GUIDED BY
CONCEPTUAL FRAMEWORK AS SHOWN IN
THIS FIGURE.
AS MENTIONED, THERE ARE THREE
MAJOR BUCKETS THAT WERE
CONSIDERED FOR CHRONIC
CONDITIONS.
FEMALE-SPECIFIC AND GYNECOLOGIC
CONDITIONS THAT LEAD TO
SIGNIFICANT MORBIDITY, CHRONIC
CONDITIONS THAT PREDOMINANTLY
IMPACT OR AFFECT WOMEN
DIFFERENTLY, AND A THIRD
CATEGORY, THE ACCUMULATION OF
MULTIPLE CHRONIC CONDITIONS,
SPECIFIC RESEARCH AREAS WHICH
WERE IDENTIFIED.
THE RESEARCH AREAS THAT WE
ACTUALLY FOCUSED ON AS YOU CAN
SEE HERE INCLUDED IMPACT OR
BURDEN, PATHOPHYSIOLOGY,
PREVENTION, DIAGNOSIS, AND
TREATMENT AND MANAGEMENT.
THE COMMITTEE CONSIDERED AREAS
ON THE TRANSLATIONAL RESEARCH
SPECTRUM FROM BASIC SCIENCE TO
OP LAITION HEALTH.
AND HOW THESE FINDINGS MAY TRANS
LALATE INTO INTERVENTIONS IN THE
HEALTHCARE SYSTEM ULTIMATELY.
WE ALSO TOOK INTO ACCOUNT THE
LIFECOURSE AND INFLUENCE OF
STRUCTURAL AND SOCIAL
DETERMINANTS OF HEALTH RELATED
TO SEX AND GENDER AS INTEGRAL
COMPONENTS.
THIS FRAMEWORK INFORMED THE
COMMITTEE'S COMPREHENSIVE
RESEARCH AGENDA.
IN CHAPTER 2, THE COMMITTEE
INTRODUCED THE ESSENTIAL FACTORS
NECESSARY FOR UNDERSTANDING
CHRONIC CONDITIONS IN WOMEN
THROUGHOUT THEIR LIVES.
THESE INCLUDE STAGES ACROSS THE
LIFECOURSE, STARTING IN UTERO,
EXTENDING TO OLDER ADULTHOOD,
AND ALSO MARKING REPRODUCTIVE
MILESTONES AS WE'VE HEARD TODAY
IN MANY OF THE TALKS.
REPRODUCTIVE MILESTONES AND
TRANSITIONS.
WE ALSO TOOK INTO ACCOUNT THE
INFLUENCING FACTORS YOU SEE AT
THE BOTTOM THERE, INCLUDING SEX
AND GENDER, BIOLOGY,
ENVIRONMENT, DIET, STRESS, AND
SOCIAL DETERMINANTS OF HEALTH.
THE COMMITTEE CHOSE TO CLARIFY
SEVERAL KEY TERMS RELEVANT TO
THIS REPORT THAT WERE IMPORTANT
IN INFORMING THE WORK, AND I
THINK IT'S IMPORTANT FOR ME TO
REVIEW A FEW OF THOSE WITH YOU
TODAY.
THE COMMITTEE ADOPTED THE U.S.
DEPARTMENT OF HEALTH AND HUMAN
SERVICES DEFINITION OF CHRONIC
CONDITIONS.
WHICH DESCRIBES THIS TERM AS
CONDITIONS THAT LAST ONE YEAR OR
MORE AND REQUIRE ONGOING MEDICAL
ATTENTION OR LIMIT SELF-CARE AND
INDEPENDENT LIVING, SOCIAL
INTERACTIONS, O.A.R. QUALITY OFF
LIFEMENT WE WERE INITIALLY
ENTITLED DEBILITATING CONDITIONS
IN OUR TITLE FOR OUR COMMITTEE.
BUT WE REMOVED THE TERM ALMOST
IMMEDIATELY.
WE AS A COMMITTEE AGREED THAT
THIS TERM NEGATED THE
EXPERIENCES OF SO MANY WOMEN WHO
LIVE WITH CHRONIC CONDITIONS AND
HAVE DEVELOPED COPING MECHANISMS
THAT HELP THEM FUNCTION MORE
FULLY.
THE COMMITTEE ALSO DEFINED
MULTIPLE CHRONIC CONDITIONS,
WHICH ARE TWO OR MORE CHRONIC
PHYSICAL OR MENTAL HEALTH
COMPANIES THAT CO-OCCUR BUT MAY
OR MAY NOT DIRECTLY INTERACT.
IN THIS REPORT, THE COMMITTEE
DEFINES WOMAN TO INCLUDE ANY
INDIVIDUAL WHO CONSIDERS
THEMSELVES TO BE A WOMAN OR WAS
ASSIGNED FEMALE SEX AT BIRTH.
RELATED TO SEX AND GENDER, THE
COMMITTEE REGARD BIOLOGIC
REGARDED BIOLOGICAL DIFFERENCES
AS SEX DIFFERENCES WHEREAS THOSE
ASSOCIATED WITH THE SOCIAL
ENVIRONMENT AS GENDER
DIFFERENCES.
THESE INCLUSIVE CONDITIONS WERE
INTENDED TO RECOGNIZE
INDIVIDUALS WHO HAVE BEEN
AFFECTED BY A SET OF BIOLOGICAL
AND SOCIAL FACTORS THAT
INFLUENCE WOMEN DIFFERENTLY THAN
MEN.
WE STRESSED THE IMPORTANCE OF
DISTINGUISHING BETWEEN SOCIAL
AND STRUCTURAL DETERMINANTS OF
HEALTH SMED STRUCTURAL FACTORS
WERE DEFINED AS THE MACRO
FECTORS SUCH AS LAWS, POLICIES
AND NORMS THAT SHAPED THE
DISTRIBUTION OF SOCIAL
DETERMINANT OF HEALTH ACROSS AND
WITHIN SOCIAL GROUPS.
THE COMMITTEE EXPLICITLY CALLS
SUCH FACTORS OUT AS SEXISM,
HOMOPHOBIA, HETEROSEXISM, RACISM
AND AGEISM.
THE COMMITTEE REVIEWED
DETERMINANTS SUCH AS ACCESS TO
EDUCATION QUALITY, HEALTH,
ECONOMIC STABILITY AND BUILT
ENVIRONMENT AND SOCIAL AND
COMMUNITY CONTEXT.
THIS NEW CONSENSUS REPORT REALLY
DOES A GREAT JOB IN SUMMARIZING
THE COMPLEXITIES OF EVERYTHING I
JUST MENTIONED IN 10 OVERARCHING
CONCLUSIONS AND 18
RECOMMENDATIONS.
AND CALLS ON THE NATIONAL
INSTITUTE OF HEALTH AND OTHER
FEDERAL AGENCIES TO SUPPORT
RESEARCH WHERE SIGNIFICANT
KNOWLEDGE GAPS EXIST AROUND
FEMALE SPECIFIC AND GYNECOLOGIC
CONDITIONS AS WELL AS CONDITIONS
THAT PREDOMINANTLY IMPACT OR
AFFECT WOMEN DIFFERENTLY.
THIS SET OF RECOMMENDATIONS
SERVE AS A RESEARCH AGENDA.
NOW, WITHIN ITS 10 CHAPTERS, THE
REPORT OUTLINES THESE SEVEN KEY
AREAS WHERE RESEARCH GAPS OR
RESEARCH DESERT AS WE HEARD FROM
OUR LAST SPEAKER, RESIDE, AND
THAT ARE ACTIONABLE TOWARDS
INCREASING FUNDING FOR RESEARCH
BY NIH AND OTHER RELEVANT
AGENCIES.
THESE AREAS AS I MENTIONED ARE
LISTED HERE, AND THEY CREATE THE
SCAFFOLD FOR THE RECOMMENDATIONS
LAID OUT IN THIS REPORT, AND
WE'LL WALK THROUGH THIS FOR THE
REMAINING PART OF THIS
PRESENTATION.
BEGINNING WITH RECOMMENDATION
ONE, IMPACT OF CHRONIC
CONDITIONS IN WOMEN.
CHAPTERS THREE AND FOUR
HIGHLIGHTED FINDINGS
UNDERSCORING THAT CHRONIC
CONDITIONS WITH UNKNOWN ETIOLOGY
LACK A STANDARD CRITERIA FOR
DIAGNOSIS AND SYMPTOMS THAT
OVERLAP WITH OTHER CONDITIONS,
HINDER THE ABILITY TO OBTAIN AN
ACCURATE MEASURE OF IMPACT.
CONSEQUENTLY, THERE'S A PAUCITY
OF DATA MEASURING THE IMPACT OF
CHRONIC CONDITIONS INCLUDING
PREVALENCE, QUALITY OF LIFE AND
ECONOMIC IMPACT.
FOR MANY OF THESE CONDITIONS
THAT WERE REVIEWED IN THIS
REPORT.
THEREFORE, WE RECOMMENDED THAT
RESEARCH IS NEEDED TO IMPROVE
ESTIMATE OS OF THE IMPACT OF
CHRONIC CONDITIONS IN WOMEN.
SPECIFICALLY, RESEARCH IS NEEDED
FOR IMPROVED DIAGNOSTIC ACCURACY
AS WE'D HEARD IN PREVIOUS
PRESENTATIONS FOR CHRONIC
CONDITIONS.
SPECIFIC TO OUR -- EXPERIENCED
DIFFERENTLY BY WOMEN.
IN SUMMARY OF THESE SPECIFICS,
BETTER CHARACTERIZATION OF THESE
DIFFERENCES IS NEEDED.
CURRENT CHRONIC CONDITION
SURVEILLANCE SYSTEMS FAIL TO
COLLECT DATA ON A NUMBER OF
FEMALE-SPECIFIC AND GYNECOLOGIC
CONDITIONS OR FAIL TO PUBLISH
DISAGGREGATED DATA.
ON CHRONIC CONDITIONS THAT
PREDOMINANTLY IMPACT OUR AFFECT
WOMEN DIFFERENTLY.
THEREFORE, WE ASK THAT THOSE WHO
CONDUCT NATIONAL SURVEILLANCE
AND POPULATION-BASED STUDIES
SHOULD BE ENCOURAGED TO EXPAND
DATA COLLECTION ACTIVITIES.
MOVING ON TO RECOMMENDATION TWO,
UNDER THE THEME OF BIOLOGY AND
PATHOPHYSIOLOGY OF CHRONIC
CONDITIONS IN WOMEN.
AND I MUST SAY, DR. ARNOLD WAS
PARTICULARLY HELPFUL IN GUIDING
US THROUGH THIS PART OF OUR
DISCUSSION IN THE REPORT.
THIS IS COVERED IN CHAPTERS 2,
5, 6 AND 9 OF THE REPORT, WHICH
HIGHLIGHTED EVIDENCE ON THE
BIOLOGICAL MECHANISMS THAT
CONTRIBUTE TO CHRONIC CONDITIONS
IN WOMEN.
WHICH THIS KNOWLEDGE IS CRUCIAL
FOR DEVELOPING APPROACHES TO
DIAGNOSE, TREAT AND PREVENT
FEMALE-SPECIFIC AND GYNECOLOGIC
CONDITIONS.
AND THOSE THAT PREDOMINANTLY
IMPACT OR AFFECT WOMEN
DIFFERENTLY.
HOW ESTROGENS AFFECT CHRONIC
CONDITIONS IN WOMEN ARE NOT
WELL-KNOWN ACROSS ALL CHRONIC
CONDITIONS AND THE INTERACTION
OF SEX HORMONES AND
GONADOHORMONES IS POORLY
UNDERSTOOD.
THEREFORE, THE REPORT RECOMMENDS
THAT NIH AND OTHER RELEVANT
RESEARCH AGENCIES SHOULD SUPPORT
RESEARCH TO UNDERSTAND THE
INDEPENDENT AND INTERACTING
ROLES OF GONADAL HORMONES AND
SEX CHROMOSOME GENES, CAUSING
SEX DIFFERENCES.
IN ADDITION, WE NEED TO DEVELOP
A BETTER UNDERSTANDING OF HOW
INFLAMMATORY AN IMMUNE PATHWAY
AFFECT CHRONIC CONDITIONS IN
WOMEN AND SUPPORT RESEARCH IN
SPECIFIC AREAS AS LISTED BELOW
ON THIS SLIDE.
RESEARCH HAS NOT YET DISCOVERED
THE GENETIC DRIVERS OF VERY
EXPERIENCES OF CHRONIC
CONDITIONS EITHER.
AND EFFORTS, THEREFORE, ARE
NEEDED TO FURTHER DISENTANGLE
THE VARIOUS SUBTYPES AND
HETEROGENEITY OF CHRONIC
CONDITIONS THAT AFFECT WOMEN TO
INFORM NOVEL TREATMENTS.
THEREFORE, THE REPORT RECOMMENDS
THAT GREATER SUPPORT OF RESEARCH
IS NEEDED TO BETTER UNDERSTAND
THE GENETIC DRIVERS OF SUBTYPES
AND SYMPTOM HETEROGENEITY OF
FEMALE-SPECIFIC AND GYNECOLOGIC
CONDITIONS.
AND ENSURE THE DATABASES USED IN
SUCH STUDIES ARE DIVERSE, GIVEN
THE OBSERVATION OF SUBPOPULATION
DIFFERENCES.
THE LACK OF SUITABLE ANIMAL
MODELS AND OTHER PRE-CLINICAL
SYSTEMS FOR EXPLORING THE
BIOLOGICAL MECHANISMS UNDERLYING
CHRONIC CONDITIONS IN WOMEN MUST
ALSO BE ADDRESSED, SO I WAS VERY
DELIGHTED TO HEAR SOME OF THAT
PROGRESS MADE IN THIS SPACE IN
THE LAST PANEL.
MOVING ON TO RECOMMENDATION
THREE, UNDER THE THEME OF
FEMALE-SPECIFIC FACTORS AND
CHRONIC CONDITIONS.
AS DISCUSSED IN CHAPTERS 5 AND
6, WITH EACH CHRONIC CONDITION,
REA PRODUCTIVE MILESTONES ARE
KEY FACTORS INFLUENCING THE
DEVELOPMENT OF CHRONIC
CONDITIONS IN WOMEN.
THE REPORT HIGHLIGHT THAT
VARIATION IN THESE MILESTONES
SUCH AS EARLY MENARCHE, A
SHORTER REPRODUCTIVE WINDOW,
INCLUDING EARLY MENOPAUSE AND
HORMONAL FLUCTUATIONS PLAY A
ROLE IN CONDITIONS SUCH AS
ENDOMETRIOSIS, WHICH HAS BEEN
DISCUSSED TODAY, DEPRESSION,
CARDIOVASCULAR DISEASE, STROKE,
AND HIV, BUT THEIR ROLE IS LESS
UNDERSTAND FOR OTHER CHRONIC
CONDITIONS.
THEREFORE, THE REPORT RECOMMENDS
THAT NIH AND OTHER RELEVANT
RESEARCH AGENCIES SHOULD SUPPORT
RESEARCH TO BETTER UNDERSTAND
EXACT MECHANISMS, HORMONAL
FLUCTUATIONS PLAY IN THE
DEVELOPMENT OF CHRONIC
CONDITIONS IN WOMEN.
THIS INCLUDES THE FOLLOWING AREA
SUCH AS CHRONIC CONDITIONS SUCH
AS THE AGE OF MENARCHE, WHETHER
OR NOT THE AGE OF THE START OF
PERIODS ACTUALLY MAKES A
DIFFERENCE IN THE SEVERITY OF
THESE CHRONIC CONDITIONS,
MENSTRUAL CYCLE REGULARITY OR
IRREGULARITY.
LENGTH AND MENSTRUAL CYCLE
PHASES.
AS WELL AS THE EFFECTS OF EARLY
AND PREMATURE MENOPAUSE AS
ANOTHER EXAMPLE, AND
CHARACTERIZING THESE MILESTONES
BASED ON ANCESTRAL AND ETHNIC
GROUPS OF WOMEN AS WELL AS
LGBTQIA+ WOMEN.
THIS REPORT ALSO HIGHLIGHTS THAT
A DECLINE AND CHANGE OF HORMONE
LEVELS DURING MENOPAUSE AND
PERIMENOPAUSE HAS SIGNIFICANT
EFFECT, SUCH AS THE SYMPTOM THAT
MANY WOMEN EXPERIENCE, AND
RESEARCH HAS YET TO IDENTIFY THE
EXACT BIOLOGICAL PATHWAYS THAT
CAUSE THESE EFFECTS.
RESEARCH HAS IDENTIFIED THE
REDUCTION IN ESTROGEN LEVELS IN
POST MENOPAUSE -- THAT POST
MENOPAUSE PERIOD AS AN IMPORTANT
CONTRIBUTOR TO DEVELOPING
SPECIFIC CHRONIC CONDITIONS,
MOST NOTABLY CARDIOVASCULAR
DISEASE AND STROKE.
HOWEVER, ITS INFLUENCE ON OTHER
CHRONIC CONDITIONS SUCH AS
SARCOPENIA IS POORLY UNDERSTOOD.
THEREFORE, THE REPORT RECOMMENDS
THAT THERE SHOULD BE GREATER
FOCUS ON RESEARCH THAT AIMS TO
DEVELOP NEW AND BETTER
APPROACHES FOR ADDRESSING THE
SYMPTOMS THAT AFFECT WOMEN
DURING PERIMENOPAUSE, MENOPAUSE,
AND POST MENOPAUSE.
MOVING ON TO RECOMMENDATIONS
4 THROUGH 6 AND THE THEME HERE,
DISPARITIES AND LIFE
EXPERIENCES.
CHAPTERS 2, 5, 6, AND
7 INTRODUCE THE BACKGROUND ON
HOW STRUCTURAL AND SOCIAL
DETERMINANTS OF HEALTH ARE KEY
FACTORS THAT CONTRIBUTE TO THE
DEVELOPMENT, DIAGNOSIS,
TREATMENT AND PROGRESSION OF
CHRONIC CONDITIONS IN WOMEN, AND
THAT EXISTING RESEARCH PRIMARILY
EXAMINES DIFFERENCES IN CHRONIC
CONDITIONS IN WOMEN BY SOCIAL
GROUP IDENTITY, BUT NOT HOW
STRUCTURAL AND SOCIAL
DETERMINANTS OF HEALTH INTERSECT
TO CONTRIBUTE TO DISPARITIES.
RESEARCH IS NEEDED TO BETTER
UNDERSTAND MULTIPLE SOCIAL
IDENTITIES AND HOW THEY INTERACT
WITH STRUCTURAL AND SOCIAL
DETERMINANTS OF HEALTH, TO
INFLUENCE CHRONIC CONDITIONS IN
WOMEN ACROSS THE ENTIRE
LIFECOURSE.
IT'S ALSO DISCUSSED IN CHAPTER W
OF VARIOUS CHRONIC CONDITIONS
THROUGHOUT THE REPORT THAT
ADVERSE AND/OR TRAUMATIC
CHILDHOOD EXPERIENCES AND
SOCIETAL GENDER EXPECTATIONS MAY
EXPOSE WOMEN TO TRAUMATIC EVENTS
THROUGHOUT THEIR LIVES THAT CAN
ADVERSELY AFFECT THEIR HEALTH.
THEREFORE, THE REPORT RECOMMENDS
SUPPORT FOR RESEARCH THAT WILL
EXPLORES THE ROLE OF TRAUMATIC
EXPERIENCES AS RISK FACTORS IN
DEVELOPMENT OF CHRONIC
CONDITIONS THROUGHOUT THE
LIFECOURSE.
LASTLY, THERE IS A LOT OF
EVIDENCE THAT HEALTH PROMOTING
BEHAVIORS ARE ASSOCIATED WITH
DECREASED RISK FOR CHRONIC
CONDITIONS.
THEREFORE, WE NEED GREATER FOCUS
ON RESEARCH TO DEEPEN OUR
UNDERSTANDING REGARDING THE ROLE
OF THESE LIFESTYLE BEHAVIORS ON
THE DEVELOPMENT OF CHRONIC
CONDITIONS IN WOMEN.
MOVING ON TO RECOMMENDATION 7,
IN CHAPTERS 6 AND 8, IT WAS
NOTED THAT WOMEN MAY EXHIBIT
DIFFERENCES IN PRE-CLINICAL AND
CLINICAL PRESENTATION OF
FEMALE-SPECIFIC AND
FEMALE-DOMINANT CHRONIC
CONDITIONS, AND THE FAILURE TO
DIFFERENTIATE CONDITION DISEASE
PRESENTATION BY SEX AND GENDER
HAS CONTRIBUTED TO SIGNIFICANT
MORBIDITY AND MORTALITY FROM
MANY CHRONIC CONDITIONS.
IN ADDITION, DIAGNOSTIC TOOLS
AND SEX-SPECIFIC BIOMARKERS ARE
LACKING FOR CERTAIN CHRONIC
CONDITIONS.
HINDERING THE ABILITY TO
ACCURATELY MAKE THE CORRECT
DIAGNOSIS.
THEREFORE, TO IMPROVE EARLY AND
ACCURATE DETECTION AND DIAGNOSIS
OF CHRONIC CONDITIONS IN WOMEN,
RESEARCH IS NEEDED TO DEVELOP
SEX AND GENDER-SPECIFIC
DIAGNOSTIC TOOLS FOR CONDITIONS
IN WHICH THERE ARE CLEAR
DIFFERENCES IN THE CLINICAL
PRESENTATION OF DISEASES IN
WOMEN SUCH AS CARDIOVASCULAR
DISEASE.
NACHHD, DIAGNOSTIC TOOLS NEED TO
BE DEVELOPED THAT CAN MORE
ACCURATELY BE DISTINGUISHED
BETWEEN CHRONIC CONDITIONS BUT
SHARE SIMILAR SYMPTOMS SUCH AS
FATIGUE AS A COMMON SYMPTOM
ACROSS MANY CHRONIC CONDITIONS,
AND EXPLORE A MULTILEVEL
APPROACH TO DIAGNOSIS THAT
ENCOMPASSES IDENTIFYING
BIOLOGICAL MARKERS, DEVELOPING
TOOLS THAT CAPTURE VARIATION IN
HOW SYMPTOM MANIFEST, AND
INCORPORATING THE LIVED
EXPERIENCE AND ENGAGING WITH
HEALTH SYSTEMS.
MAKING PROGRESS.
RECOMMENDATION EIGHT.
THE FOCUS HERE, MULTIPLE CHRONIC
CONDITIONS IN WOMEN.
IN CHAPTER 8, IT WAS HIGHLIGHTED
THAT MULTIPLE CHRONIC CONDITIONS
HAVE A SIGNIFICANT EFFECT ON
WOMEN, WITH EVIDENT GENDER
DIFFERENCES AND PRESENTATION OF
CLUSTERS OF CHRONIC CONDITIONS.
HOWEVER, RESEARCH HAS ACTIVELY
PRIORITIZED THE STUDY OF SINGLE
DISEASES AND SINGLE-DISEASE
MODELS.
TO UNDERSTAND THE CELLULAR
PROCESSES THAT HAVE BEEN PASS
TEU LATED TO BE POSSIBLE TARGETS
THAT COULD PLAY A ROLE IN
PREVENTING OR AMEAL YOUR AGENT
MULTIPLAMELIORATINGCHRONIC COND,
RESEARCH IS NEEDED TO BETTER
UNDERSTAND THE BIOLOGICAL
MECHANISMS INVOLVED IN THE
DEVELOPMENT OF MULTIPLE CHRONIC
CONDITIONS IN WOMEN, INCLUDING
AGE-RELATED MECHANISMS AND
INFLAMMATION.
WE MUST FURTHER INVESTIGATE THE
ROLE OF CELLULAR SENESCENCE IN
THE DEVELOPMENT OF MULTIPLE
CHRONIC CONDITIONS AND HOW ITS
REVERSAL OR PREVENTION CAN
POTENTIALLY DELAY DEVELOPMENT.
IT WOULD BE HELPFUL TO DEVELOP
AN ANIMAL MODEL THAT EXAMINED
COOCCURRENCE OF MORBIDITIES.
OF THESE CONDITIONS.
ALSO, IN CLINICAL RESEARCH,
STUDIES OF CHRONIC CONDITIONS
HAVE BEEN HAMPERED BY A LACK OF
STANDARDIZED DEFINITIONS, AS
WELL AS DIAGNOSTIC APPROACHES.
AND THAT HAS RESULTED IN
CHALLENGES AS RELATE TO
PREVENTION AND TREATMENT.
TO IMPROVE THE DIAGNOSIS OF
MULTIPLE CHRONIC CONDITIONS IN
WOMEN, NEW MEASUREMENT ACTUALS
NEED TO BE DEVELOPED FOR
MULTIPLE CHRONIC CONDITIONS THAT
INCLUDE FEMALE-SPECIFIC AND
GYNECOLOGIC CONDITIONS TO MORE
FULLY UNDERSTAND THE IMPACT AND
REVIEW AND VALIDATE DIAGNOSTIC
OR MEASUREMENT TOOLS FROM
MULTIPLE CHRONIC CONDITIONS TO
AID IN THE DEVELOPMENT OF A
STANDARDIZED DEFINITION.
IT WAS ALSO HIGHLIGHTED IN
CHAPTER 8 THAT EVIDENCE-BASED
GUIDELINES ARE LACKING, FOR
TREATING AND MANAGING THE
COMPLEX INTERACTIONS BETWEEN
CONDITIONS.
INTERACTIONS OF SPECIFIC
TREATMENTS, RESULTING IN
POLYPHARMACY CAN CONTRIBUTE TO
DEVELOPING OR EXACERBATING OTHER
CHRONIC CONDITIONS.
THE DESIGN OF TREATMENT AND
MANAGEMENT APPROACHES SHOULD BE
INFORMED BY THE EXPERIENCES OF
WOMEN LIVING WITH THESE MULTIPLE
CHRONIC CONDITIONS.
THEREFORE, THE REPORT RECOMMENDS
THAT RESEARCH APPROACHES THAT
APPROPRIATELY STUDY MULTIPLE
CHRONIC CONDITIONS IN WOMEN AND
ENSURE THE REPRESENTATION OF
WOMEN WITH MULTIPLE CHRONIC
CONDITIONS IN RESEARCH DESIGNS
IS REALLY SIGNIFICANTLY NEEDED.
WE MUST DO THIS TO IMPROVE THE
TREATMENT AND CARE OF WOMEN WITH
MULTIPLE CHRONIC CONDITIONS, AND
CERTAINLY RESEARCH IS NEEDED TO
DEVELOP EVIDENCE-BASED --
EVIDENCE-BASED TREATMENT AND
MANAGEMENT GUIDELINES FOR WOMEN
WITH MULTIPLE CHRONIC
CONDITIONS.
INEQUITIES AND WOMEN-CENTERED
RESEARCH WAS CERTAINLY AN
IMPORTANT COMPONENT OF THIS
REPORT.
AS WELL.
INEQUITIES IN WOMEN'S HEALTHCARE
STEM FROM BIAS, DISCRIMINATION
AND STIGMA IN MEDICAL TREATMENT.
STRUCTURAL SEXISM ALSO CAN
SIGNIFICANTLY INFLUENCE HEALTH
POLICIES, INCLUDING ACCESS TO
CARE AND RESEARCH FUNDING.
AND I'M SURE WE'RE ALL AWARE,
FOR EXAMPLE, THAT THE PAIN THAT
WOMEN EXPRESS CLINICALLY IN
THE -- IN PRACTICE, IN MANY
PRACTICES, IS MORE OFTEN
UNDERESTIMATED BY CLINICIANS
WHEN COMPARED TO MEN.
AND SO A HEALTH EQUITY LENS IS
IMPORTANT FOR IMPROVING
HEALTHCARE ACCESS, TREATMENT
PARADIGMS AND PATIENT-CENTERED
OUTCOMES IN WOMEN.
THEREFORE, THE REPORT RECOMMENDS
THAT RESEARCH IS NEEDED TO
ADDRESS INEQUITIES THAT CONTINUE
TO EXIST FOR WOMEN IN THE
HEALTHCARE SETTING.
SPECIFICALLY CONSIDERING THE
ACTION ITEMS LISTED BELOW.
AND THEN FINALLY, RECOMMENDATION
10.
INEQUITIES AND WOMEN CENTER
RESEARCH.
DESPITE PROGRESS REGARDING THE
INCLUSION AND REPRESENTATION OF
WOMEN IN VARIOUS FIELDS OF
RESEARCH, THE EVIDENCE ON
CHRONIC CONDITIONS POINTS TO A
LACK OF ACTIVE INCLUSION OF
WOMEN FROM DIFFERENT ANCESTRIES,
ETHNIC, GENDER, IDENTITY AND
SEXUAL ORIENTATION GROUPS OF
RESEARCH, THE REPORT CONCLUDED
THAT WOMEN CENTRIC AND COMMUNITY
INCLUSIVE RESEARCH STRATEGIES
CAN HELP ENSURE THAT RESEARCH
ACTIVITIES ADDRESS THE UNIQUE
HEALTH NEEDS OF WOMEN, LEADING
TO MORE EFFECTIVE AND EQUITABLE
HEALTH OUTCOMES.
AND SO WE MUST ACTUALLY SUPPORT
AND ADVOCATE FOR RESEARCH THAT
IS WOMEN-CENTRIC.
WE MUST RECRUIT WOMEN FROM
DIFFERENT ANCESTRAL ETHNIC
GENDER IDENTITY, AGE AND SEXUAL
ORIENTATION BACKGROUNDS, AND
UNDERSERVED RURAL POPULATIONS TO
BETTER DEFINE THE FULL SPECTRUM
OF PRE-CLINICAL AND CLINICAL
DISEASE PRESENTATION.
WE MUST INVOLVE WOMEN WITH
CHRONIC CONDITIONS, INCLUDING
THEIR COMMUNITIES, IN DESIGN,
IMPLEMENTATION AND DISSEMINATION
OF RESEARCH FINDINGS.
WE MUST USE NOVEL TECHNIQUES FOR
ENGAGING AND INCORPORATING WOMEN
WHO HAVE YET TO SEEK CARE DUE TO
OBSTACLES IN ACCESSING
HEALTHCARE SERVICES, OR BECAUSE
THEIR CONDITIONS ARE IN A
PRE-CLINICAL STAGE.
WE MUST USE COMMUNITY-BASED
RESEARCH APPROACHES, AND WE MUST
ACCOUNT FOR SEX AND GENDER IN
STUDIES WHERE APPROPRIATE AND
STANDARDIZED MEASURES FOR
CAPTURING THESE VARIABLES
ACCURATELY.
SO IN SUMMARY, MUCH OF WHAT I'VE
HEARD TODAY IS REALLY IN THIS
RESEARCH AGENDA.
WE JUST REALLY NEED TO PUT A
BRIGHTER SPOTLIGHT ON IT, AND
HOPEFULLY THIS REPORT WILL
CONTRIBUTE TO THAT PURPOSE, IF
YOU WILL, THAT CAUSE.
AND WE MADE AN ATTEMPT TO
IDENTIFY THE KEY RESEARCH GAPS
AND WE HOPE THAT THIS WILL HELP
TO BRIDGE THOSE GAPS WITH
GREATER UNDERSTANDING OF HOW
BIOLOGICAL AND SOCIAL FACTORS
CAN INFLUENCE THE TRAJECTORY OF
CHRONIC CONDITIONS DURING THE --
OVER THE ENTIRE LIFECOURSE OF A
WOMAN.
ULTIMATELY, RESEARCH OUTCOMES
WOULD LEAD TO GREATER DIAGNOSTIC
RIGOR, BERT DATA ON THE IMPACT
OF THESE CONDITIONS, AND MORE
EFFECTIVE THERAPEUTIC
INTERVENTIONS.
AND WOMEN-CENTERED CARE.
SO THE REPORT YOU HAVE IN YOUR
POSSESSION, BUT IT CAN ALSO BE
DOWNLOADED AT THIS WEBSITE,
AND CERTAINLY I KNOW I'M AT
MINUS 3 MINUTES, BUT HAPPY TO
ENTERTAIN ANY QUESTIONS AND I
WOULD INVITE DR. ARNOLD AS WELL
TO MAKE ANY COMMENTS HE WOULD
LIKE TO MAKE AS WELL.
>> THANK YOU, DR. HIGGINBOTHAM.
AND BEFORE WE GO FURTHER, I WANT
TO ACKNOWLEDGE THE LEADERSHIP OF
DR. SARAH TEMKIN HERE, WHO'S THE
LEAD FOR THIS EFFORT AND
ENGAGEMENT AT ORWH.
THANK YOU VERY MUCH.
[APPLAUSE]
SO ART AND EVE ARE AVAILABLE
FROM QUESTIONS FROM THE ADVISORY
COMMITTEE.
DR. HIGGINS.
>> SO WONDERFUL LECTURE, AND
WONDERFUL DOCUMENT.
AND I WAS JUST -- DID THE
COMMITTEE GIVE ANY THOUGHT TO
CLINICALLY HOW WE MANAGE
PATIENTS THAT HAVE THESE
MULTIPLE CONDITIONS?
I WAS ON A PANEL DISCUSSING THIS
AROUND -- THIS PAST WEEKEND
AROUND CIGARETTE SMOKING AND
POPULATION OF PTSD, HIV, AND --
WHAT WAS THE OTHER ONE?
WELL, THAT'S ENOUGH.
AND WE WERE TRYING TO THINK ON
THE COMMITTEE, LIKE, TEAM
SCIENCE OR WHAT -- YEAH, SO --
>> AND YOU MIGHT ACTUALLY FOCUS
ON CHAPTERS 8 AND 9, MULTIPLE
CHRONIC CONDITIONS, AS WELL AS
OUR CHAPTER WHERE WE REALLY
FOCUS ON THE CHALLENGES WITH
TRANSLATION INTO CLINICAL
PRACTICE.
AND WITHIN CHAPTER 9, WE TALK,
FOR INSTANCE, ABOUT THE LEARNING
HEALTH SYSTEM, AND THE
IMPORTANCE OF HAVING
INTERDISCIPLINARY ENGAGEMENT.
I THINK IT'S A MATTER OF REALLY
OPENING UP THE DOOR BETWEEN
SPECIALTIES, AND ONE OF THE
BOOKS I'LL JUST MENTION, I'VE
MENTIONED TO A COUPLE OF OTHER
PEOPLE, I'M READING ELDERHOOD BY
THE GERIATRICIAN FROM UCSF AND
SHE TALKS ABOUT THE IMPORTANCE
OF INTERDISCIPLINARY ENGAGEMENT,
PARTICULARLY FOR OUR OLDER
PATIENTS.
AND THAT'S WHAT WE NEED TO DO.
BUT THERE'S GOT TO BE THE
CULTURE OF A LEARNING HEALTH
SYSTEM AS A BASIC PLATFORM.
>> IN THE BILLING SYSTEM, YEAH,
THANK YOU.
>> SO THE BILLING SYSTEM --
WELL, I MEAN, IN MANY STATES OR
AT LEAST -- I'M ON THE BOARD OF
MASS EYE AND EAR AND I KNOW AT
LEAST IN MASSACHUSETTS, MEDICAID
IS MOVING MORE TOWARDS
VALUE-BASED CARE, SO AS WE GET
INTO THAT CONVERSATION OF
VALUE-BASED CARE, WE'RE GOING TO
BE REIMBURSED FOR OUR OUTCOMES.
BUT IT'S NOT GOING AS QUICKLY AS
IT SHOULD.
>> DR. NOEL.
>> VERY NICE PRESENTATION.
A LOT OF WORK DEFINITELY.
I WAS JUST WONDERING IF THERE
WAS ANY THOUGHTS THAT WERE PUT
INTO HOW DO WE PRIORITIZE IN THE
SENSE THAT WHEN YOU LOOK,
THERE'S A LOT OF CHRONIC
CONDITIONS, DO WE LOOK AT
PREVALENCE, DO WE LOOK AT IMPACT
THAT IT COULD HAVE ON THE WOMAN,
DO WE LOOK AT MORTALITY, YOU
KNOW, WHICH DISEASE WOULD LEAD
MORE TO MORTALITY, SO BECAUSE
THERE'S SO MANY DIFFERENT
FACTORS AND DIFFERENT CONDITIONS
THAT GOES INTO THAT, AND
RESEARCH IS DEFINITELY NEEDED,
YOU HAVE IDENTIFIED A LOT OF
GAP, BUT HOW DO WE PRIORITIZE?
>> YOU KNOW, THAT'S A GREAT
QUESTION, AND I REALLY WOULD
LIKE, ART, IF YOU WOULD CHIME IN
HERE BECAUSE I DO THINK IT
STARTS IN THE BASIC SCIENCE.
WE COULD HAVE BIOMARKERS, THAT
WOULD HELP US WITH PREVENTION
AND DIAGNOSIS BUT ART, DO YOU
HAVE ANY THOUGHTS ON THAT
QUESTION?
>> SO I CAN'T ADDRESS ANYTHING
CLINICALLY BECAUSE I'M A BASIC
SCIENTIST, BUT I SAW IT -- JUST
MORE GENERALLY, I SAW THIS
REPORT AS KIND OF A FOLLOW-UP TO
THE -- WAS IT 2001 REPORT, DOES
SEX MATTER, OKAY?
AND THERE HAVE BEEN OTHER
REPORTS, BUT IT WAS PART OF MY
OWN MOTIVATION TO SEE IT BECAUSE
I THOUGHT THAT 2001 REPORT WAS
REALLY A TURNING POINT, AND THIS
WAS A FOLLOW-UP.
AND THE SCIENCE -- THE BASIC
BIOLOGY HAS CHANGED IN THOSE
20-PLUS YEARS.
SO THAT THERE ARE NEW WAYS IN
WHICH WE IMAGINE HOW SEX
DIFFERENCES AND, THEREFORE,
DISEASES THAT AFFECT WOMEN MORE
THAN MEN, OCCUR AT THE BASIC --
NEW FACTORS THAT ARE SEX BIASING
THAT BE WE DON'T EVEN UNDERSTAND
IN ANIMAL RESEARCH YET, AND SO
THERE ARE REPORT COMING OUT
ABOUT A MOLECULE LIKE EXISTS
WHICH IS THOUGHT TO BALL PANS
MALES AND FEMALES BUT IT
ACTUALLY THEN HAS SPECIFIC
EFFECTS IN WOMEN.
AND THAT'S A NEW CONCEPT THAT A
BALANCING MOLECULE ON THE X
CHROMOSOME THAT MAKES WOMEN MORE
LIKE MEN ACTUALLY MAKES WOMEN
DIFFERENT FROM MEN AND CAUSES
DISEASES OR CONTRIBUTES TO
DISEASES MORE IN WOMEN.
SO I THINK THERE'S SOME BASIC
BIOLOGY THAT NEEDS TO DO SOME
CATCHUP NOW, AND I THINK THE
TOOLS ARE THERE AND THAT WILL
HAPPEN.
AT THE SAME TIME THAT THE
CLINICAL SIDE IS -- THIS IS A
VERY COMPLEX BOOK ACTUALLY, AND
I'VE LEARNED A WHOLE LOT.
I WAS REALLY DELIGHTED TO SERVE
WITH THE MEMBERS OF THIS
COMMITTEE WHO KNEW SO MANY
THINGS THAT I CERTAINLY DIDN'T.
SO IT WAS A HUMBLE AND
GRATIFYING EXPERIENCE.
BUT -- SO I REALLY CAN ONLY
COMMENT ABOUT THE BASIC BIOLOGY.
>> BUT I DO THINK THAT'S
IMPORTANT, BUT ALSO ON THE OTHER
END, CLINICAL GUIDELINES, YOU
KNOW, PRACTICE GUIDELINES THAT
AS LONG AS WE UNDERSTAND THEY'RE
GOING TO HAVE TO BE CONSTANTLY
TESTED AND EVALUATED AS WE LEARN
MORE ABOUT THE PATHOPHYSIOLOGY
OF THESE DISEASES, SO WE CAN DO
A LOT BY STANDARDIZING THE WAY
WE CARE FOR THESE PATIENTS, BUT
ALSO MAKING IT EASIER FOR OUR
VARIOUS DISCIPLINES TO WORK
TOGETHER TO CARE FOR THE PATIENT
AND BE MORE PATIENT-CENTERED.
SO I COULD SEE BOTH OF THOSE
PILLARS BEING IMPORTANT.
BUT MY HOPE IS IN THE BASIC
SCIENCE REALM.
>> WE NEED TO MOVE ON BECAUSE
WE'RE REALLY LATE.
AND I KNOW SOME OF YOU ARE
NEEDING TO MEET SOME OTHER
TRAVEL DEADLINES.
BUT FOR THOSE OF YOU WHO HAVE
OTHER QUESTIONS, I WOULD
ENCOURAGE YOU TO EITHER REACH
OUT TO US OR DR. HIGGINBOTHAM
AND WE CAN ACTUALLY ADDRESS
THOSE.
WE'LL BE HAPPY TO DO SO.
OKAY.
LET'S TAKE A DEEP BREATH AND
WE'RE GOING TO CHANGE OUR
DIRECTION A LITTLE BIT AND NOW
TURN TO OUR CONCEPT CLEARANCES.
SO WE'RE GOING TO PUT YOU TO
WORK.
SO WHAT I WOULD LIKE TO DO IS TO
NOW INTRODUCE OUR NEXT SPEAKER,
DR. SARAH TEMKIN, WHO IS THE
ASSOCIATE DIRECTOR FOR CLINICAL
RESEARCH AT ORWH, WHO WILL BE
PRESENTING A CONCEPT CLEARANCE
ON FEMALE-SPECIFIC CHRONIC
CONDITIONS.
DR. TEMKIN PROVIDES CLINICAL
EXPERIENCE ON ISSUES RELATED TO
THE HEALTH OF WOMEN.
HER CLINICAL RESEARCH TEAM
OVERSEES THE UNDERREPRESENTED,
UNDERSERVED AND UNDERREPORTED OR
YOUTH-RESEARCH RELATED TO
CHRONIC CONDITIONS AND
MULTI-MORBIDITY AMONG WOMEN AND
RESEARCH ON THE MULTIPLE
BIOLOGIC, SOCIAL AND BEHAVIORAL
FACTORS THAT INFLUENCE DISEASE
AND RISK AS WELL AS HEALTH
OUTCOMES OF WOMEN.
DR. TEMKIN IS A GYNECOLOGIC
ONCOLOGIST WHO EARNED HER
MEDICAL DEGREE FROM -- AND
COMPLETED A FELLOWSHIP IN
GYNECOLOGIC ONCOLOGY AT THE SUNY
DOWN STATE MEDICAL CENTER.
SHE'S BEEN VERY ACTIVE IN
CLINICAL RESEARCH THROUGHOUT HER
CAREER, HAVING SERVED AS
INVESTIGATOR FOR CLINICAL TRAILS
FOR FEMALE-SPECIFIC
MALIGNANCIES, CANCER CONTROL,
AND SUPPORTIVE CARE FOR CANCER
PATIENTS.
IN ADDITION, DR. TEMKIN HAS BEEN
RECOGNIZED FOR EXCELLENCE IN
CLINICAL CARE AS WELL AS
EXPERTISE -- DR. TEMKIN HAS
SERVED AS THE NATIONAL CANCER
INSTITUTE AS A PROGRAM OFFICER
FOR THE COMMUNITY ONCOLOGY
RESEARCH PROGRAM AND IS A
SPECIAL VOLUNTEER FOR THE
DIVISION OF CANCER PREVENTION.
WELCOME, DR. TEMKIN.
>> THANKS SO MUCH FOR HAVING ME.
I DIDN'T REALIZE I WAS GOING TO
GET MY WHOLE BIO READ.
I'M GOING TO TALK A LITTLE ABOUT
FEMALE CHRONIC CONDITIONS TODAY
FOR THIS CONCEPT CLEARANCE BY
THE SAME NAME, ADVANCING OUR
UNDERSTANDING OF FEMALE SPECIFIC
AND GYNECOLOGIC CHRONIC
CONDITIONS.
THE PURPOSE OF WHICH IS TO
INVITE RESEARCH PROJECTS TO
IMPROVE PREVENTION, DIAGNOSIS,
EARLY DETECTION AND TREATMENT
INTERVENTIONS FOR
FEMALE-SPECIFIC AND GYNECOLOGIC
CHRONIC CONDITIONS.
THE FUNDS AVAILABLE ARE
CONTINGENT UPON NIH
APPROPRIATIONS FOR MERITORIOUS
AWARDS.
WOUWE WOULD ANTICIPATE A FIVE-YR
PERIOD AND AT THE END OF THIS
PRESENTATION, WE WOULD ASK YOU
TO VOTE TO APPROVE THIS CONCEPT.
I'M GOING TO START BY GIVING A
SHORT -- THAT WE JUST HAD ON THE
NASEM ACTIVITY ON CHRONIC
CONDITIONS.
THE REASON THAT DEBILITATING WAS
IN THE TITLE IS BECAUSE THIS
ACTIVITY CAME OUT OF
CONGRESSIONAL REQUESTS IN FISCAL
YEAR 21 THAT THE NIH REVIEW ITS
PORTFOLIOS ON WOMEN'S HEALTH AND
SPECIFICALLY REVIEW THE
ACTIVITIES IN THE NIH SPECIFIC
TO MATERNAL MORBIDITY AND
MORTALITY, STAG NAT CERVICAL
CANCER SER VIEFL AND CHRONIC
DEBILITATING CONDITIONS IN
WOMEN.
SO THIS HAS BEEN A PRIORITY IN
ORWH FOR SEVERAL YEARS AND AS
LONG AS I'VE BEEN IN THE OFFICE.
WE DO KNOW THAT WOMEN HAVE
HIGHER RATES OF CHRONIC
CONDITIONS THAN MEN AND HIGHER
RATES OF MULTI-MORBIDITY.
SO AS PART OF THIS ACTIVITY,
MANY PEOPLE IN THIS ROOM ARE
FAMILIAR WITH WHAT WE CALLED THE
RAINBOW TABLE, BUT IN ORDER TO
TRY TO BE INCLUSIVE OF ALL OF
THE NIH CENTERS AND IN ORDER TO
GIVE EVERYBODY A SMALL PIECE OF
THIS AND MAKE EVERYONE FEEL AS
THIS IF THEY COULD CONTRIBUTE, E
DIVIDED THIS INTO FOUR CATEGORYS
THAT INCLUDED FEMALE-SPECIFIC,
THOSE CONDITIONS MORE COMMON IN
WOMEN, THOSE CONDITIONS THAT
OCCUR IN BOTH SEXES BUT ARE
POTENTIALLY UNDERSTUDIED IN
WOMEN, AND THEN LASTLY THOSE
CONDITIONS THAT HAVE HIGH
MORBIDITY FOR WOMEN.
AND JUST TO MAKE THIS VERY
COMPLICATED BUSY TABLE VERY
STRAIGHTFORWARD AS POSSIBLE, WE
COMPARED THE SPENDING IN FY 20
FROM THE NIH TO THE DISABILITY
ADJUSTED LIFE YEARS EXPERIENCED
BY WOMEN IN 2019, AND FROM THESE
FEW EXAMPLES, YOU CAN SEE THAT
THERE WAS A VERY WIDE RANGE,
THESE CONDITIONS, THE DISABILITY
ADJUSTED LIFE YEARS ARE HIGHER
ON THE RIGHT SIDE OF THE SCREEN
AND GO DOWN AS YOU MOVE LEFT,
BUT THE RATIO OF SPENDING TO
DISABILITY ADJUSTED LIFE YEARS
WAS SORT OF ALL OVER THE MAP,
REALLY DEMONSTRATING THAT NIH
SPENDING IS NOT ALIGNED WELL
WITH THE BURDENS OF DISEASE
AMONGST WOMEN.
WE SUMMARIZE THESE ACTIVITY FOR
ANYONE WHO'S INTERESTED IN GOING
BACK AND LOOKING AT THIS IN A
PUBLICATION IN 2023, WHERE WE
DEFINE MULTIPLE OPPORTUNITIES TO
ALIGN THE NIH RESEARCH AGENDA
WITH THE HEALTH NEEDS OF WOMEN,
INCLUDING THE INTEGRATION OF SEX
AS A BIOLOGIC VARIABLE ACROSS
THE LIFECOURSE OF WOMEN, AND
IMPROVING OUR UNDERSTANDING OF
HOW SOCIAL DETERMINANTS OF
HEALTH INFLUENCE THE HEALTH OF
WOMEN DIFFERENTLY THAN MEN.
ONE OF THE KEY OUTPUTS OF THIS
CONVENING WAS THE NATIONAL ACAD
PEES REPORT WHICH WE JUST HEARD
ABOUT WITH ITS MANY
RECOMMENDATIONS, AND I'M SO GLAD
I DON'T HAVE TO GO THROUGH ALL
OF THOSE WITH YOU, BUT I DID
WANT TO POINT OUT SPECIFICALLY
HOW THIS FRAMEWORK WAS CHANGED
BY THE COMMITTEE OR WERE
MODIFIED OR THEIR FRAMEWORK IS
DIFFERENT THAN HOURS -- OURS,
WHICH ACTUALLY I WAS DELIGHTED
BY THAT, FEMALE-SPECIFIC
CONDITIONS WERE ONE OF THREE
BOXES AT THE TOP OF THIS
FRAMEWORK, WHERE YOU CAN SEE,
AND I JUST WANT TO BE CLEAR,
LIKE ONE OF THE MAIN ISSUES WITH
THE UNDERSTUDYING AND OUR LACK
OF KNOWLEDGE ABOUT THE BASIC
PHYSIOLOGY AND LACK OF
DIAGNOSTICS TREATMENT FOR
FEMALE-SPECIFIC AND GYNECOLOGIC
CONDITIONS IS HOW IT INFLUENCES
THE ACCUMULATION OF DISEASE
ACROSS THE LIFESPAN OF WOMEN,
AND HOW THAT LEADS TO
MULTI-MORBIDITY WHICH MAY BE
LESS WELL UNDERSTOOD THAN IN
MEN.
WE KNOW THAT FEMALE SPECIFIC AND
CHRONOLOGIC CONDITIONS ARE VERY
COMMON AND CAUSE SPECIFIC
MORBIDITY PARTICULARLY AMONGST
YOUNGER PATIENTS.
THIS IS COMPOUNDED BY THE FACT
THAT THERE'S SIGNIFICANT STIGMA,
PATIENTS ARE OFTEN RELUCTANT AS
WE HEARD FROM MANY OF OUR
SPEAKERS TODAY TO DISCUSS THEIR
SYMPTOMS RELATED TO THE FEMALE
GENITAL TRACT, AND DELAYS IN
DIAGNOSIS ARE COMMON.
THE CONTRIBUTION OF THESE
DISORDERS TO MULTI-MORBIDITY IS
RARELY CONSIDERED MUCH LESS
MEASURED, AND WE KNOW THAT THERE
ARE SIGNIFICANT HEALTH
DISPARITIES IN MANY OF THESE
CONDITIONS.
WE ALSO KNOW THAT
MULTI-MORBIDITY IN WOMEN IS
COMPLICATED.
MULTI-MORBIDITY IS MORE LIKELY
TO CROSS ORGAN SYSTEMS THAN
NETWORKS OF MORBIDITY IN WOMEN
ARE ACROSS MORE ORGAN SYSTEMS
THAN THOSE IN MEN.
AND ALSO THAT WOMEN ARE MORE
LIKELY TO HAVE DISCORDANT
CHRONIC MEDICAL CONDITIONS AND
THOSE DISCORDANT CONDITIONS ARE
MORE LIKELY TO CROSS SOMATIC AS
WELL AS PSYCHIATRIC CONDITIONS.
WHEN YOU INCLUDE FACTORS THAT
ARE SOCIAL FACTORS SUCH AS FAITS
BECOMES MORE COMPLICATED.
THIS TABLE IS THE ONLY ONE WE'VE
BEEN ABLE TO FIND IN THE
LITERATURE THAT SHOWS WHAT THE
VARIABILITY IS OR HETEROGENEITY
IS OF THE DIAGNOSIS OF
MULTI-MORBIDITY ACROSS MEN AND
WOMEN OF DIFFERENT RACIAL AND
ETHNIC GROUPS.
AND SO THE SECOND OUTPUT FROM
THE ADVANCING RESEARCH ON
WOMEN'S HEALTH CONVENING THAT I
WANTED TO JUST TALK ABOUT TODAY
IN LEAD UP TO THE VOTE ON THE --
I LOST THE WORD.
CONCEPT CLEARANCE.
IS TWO FUNDING OPPORTUNITIES
THAT CAME OUT OF THE OFFICE.
THESE WERE RFA-OD-23-013 AND
014, UNDERSTANDING CHRONIC
CONDITIONING USING THE FRAMEWORK
WE HAD DEVELOPED IN THE
ADVANCING WOMEN'S HEALTH
CONFERENCE IN 2021.
WE HAD TWO RECEIPT DATES, BOTH
OF WHICH WERE PASSED.
THE FIRST ONE WAS AT THE END OF
TWEP 23.
WE HAD SEVERAL PARTNER ICOs
MENTIONED HERE AT THE BOTTOM, SO
I'M VERY PLEASED TO ANNOUNCE
THAT WE WERE ABLE TO FUND 21
AWARDS THROUGH THESE MECHANISMS
THAT CROSSED MULTIPLE DIFFERENT
ICs, SIX TO NHLBI, SIX TO
NICHD, ONE TO NIA, TWO TO NCI,
ONE TO NIAMS AND ONE TO NIDDK.
THEY WENT TO NICHD BUT ALSO TO
NHLBI, NIA AND THE NCI.
I JUST INCLUDED A FULL LIST
HERE, I KNOW IT'S TOO SMALL TO
READ, BUT TO SHOW YOU THE VERY
BROAD AND DIVERSE TOPICS THAT WE
WERE ABLE TO FUND THROUGH THIS
MECHANISM, BUT ALSO HERE
HIGHLIGHTED THE AWARDS THAT WERE
REALLY FOCUSED ON
FEMALE-SPECIFIC CONDITIONS SO
THAT YOU CAN SEE THE BREADTH OF
RESEARCH THAT THIS FUNDING
OPPORTUNITY BROUGHT IN.
THINGS LIKE MENOPAUSE, MEN TREUL
BLEEDING THAT ACTUALLY WENT TO
NHLBI BECAUSE OF THE ASSOCIATION
WITH ANEMIA, VAGINAL TOXICITY OF
RADIATION, POLYCYSTIC OVARIAN
SYNDROME, ENDOMETRIOSIS,
ADENOMYOSIS, CERVICAL DYSPLASIA,
AND PELVIC FLOOR DISORDERS.
AND THESE WENT TO A VARIETY OF
INVESTIGATORS ACROSS THE
COUNTRY.
HAASLY, I JUSTLASTLY I JUST WANO
CONTEXT THE OVERALL SPENDING, I
THINK EVERYONE IN THE ROOM KNOWS
THAT WOMEN'S HEALTH SPENDING IS
APPROXIMATELY 10% OF THE TOTAL
NIH BUDGET THAT'S BEEN PRETTY
CONSTANT FOR THE LAST NUMBER OF
YEARS.
SO IT'S HARD TO GET AN EXACT
NUMBER BUT I THINK
FEMALE-SPECIFIC CONDITIONS MAKE
UP ABOUT 12% OF THAT WHOLE
BUDGET OR ABOUT 1% EVIDENT WHOLE
NIH BUDGET SO I JUST PROVIDED A
FEW NUMBERS OF WHAT THE RCDC
PUBLIC SPENDING LOOKS LIKE FOR
SOME OF THESE CONDITIONS.
THE LARGEST AMOUNTS GO TO
OVARIAN AND CERVICAL CANCER.
LAST YEAR WAS THE FIRST YEAR WE
HAD A MENOPAUSE RCDC CODE, WHICH
WAS $56 MILLION, THEN OTHER
CANCERS, THEN THESE BENIGN
DISEASES START TO FALL TOWARDS
THE BOTTOM OF THE LIST.
SO JUST TO SUMMARIZE THIS WHOLE
CONCEPT, THE FEMALE-SPECIFIC
CHRONIC CONDITIONS ARE HIGHLY
PREVALENT, HAVE BEEN
HISTORICALLY UNDERSTUDIED ACROSS
MULTIPLE IC PRIORITIES, AND I
JUST SORT OF PUT THIS TOGETHER.
I DID NOT KNOW THAT NEXTGEN JANE
WAS GOING TO TALK AHEAD OF ME
AND PERFECTLY PREPARING ME FOR
THIS BUT SHE DID.
YOU KNOW, WHEN YOU THINK ABOUT
MENSTRUAL DISORDERS, IT DOESN'T
JUST FALL INTO THE PURVIEW OR
ALIGN WITH THE MISSION OF ONE
IC, BUT THERE ARE MULTIPLE
INSTITUTES AND CENTERS WHERE
THIS IS POTENTIALLY IMPORTANT.
WE'VE MENTIONED NHLBI THAT
FUNDED AN R01 ON ANEMIA BUT ALSO
MENSTRUAL MIGRAINES ARE A
SIGNIFICANT SOURCE OF MORBIDITY
AND ALIGNED WITH NINDS, OBESITY
CHANGES MENSTRUAL DISORDERS, THE
DIAGNOSIS AS WELL AS THE
TREATMENT FOR MANY WOMEN.
AND THAT IS ALIGNED WITH THE
NIDDK MISSION.
WE ALSO KNOW THERE ARE
SIGNIFICANT LET-RELATED
DISPARITIES FOR CONDITIONS LIKE
FIBROIDS AND ENDOMETRIOSIS, AND
WE KNOW THAT THESE INTERACTIONS
WITH OTHER CHRONIC DISEASES IS
UNKNOWN.
SO IN SUMMARY, I HOPE THAT I
HAVE CONVINCED YOU THAT THIS IS
A VALUABLE FUNDING OPPORTUNITY
TO ENHANCE OUR UNDERSTANDING OF
FEMALE-SPECIFIC CONDITIONS, AND
I WILL STOP THERE.
>> THANK YOU, DR. TIM KIN.
I'D LIKE NOW TO CALL ON THE TWO
DISCUSSANTS FOR THIS CONCEPT, WE
HAVE DR. MIELENZ AND DR. SHARPS.
I'LL HAVE DR. SHARPS GO FIRST.
>> GOOD AFTERNOON.
I REALLY DON'T HAVE ANY
QUESTIONS ABOUT THE CONCEPT, BUT
I DO HAVE JUST A FEW COMMENTS AS
WE THINK ABOUT MOVING FORWARD
WITH IT, WITH YOU I'M IN FAVOR.
AS HAS BEEN MENTIONED, I THINK
THE RESEARCH, THIS FOCUS IS
HIGHLY RELEVANT AND TIMELY, AND
WE HAVE WOMEN WHO HAVE CHRONIC
CONDITIONS AND MULTIPLE CHRONIC
CONDITIONS CERTAINLY IN THE
POPULATIONS I'VE WORKED WITH
THAT ARE LIVING LONGER, AND WE
DON'T UNDERSTAND ALL OF THE
MECHANISMS OF JUST NATURALLY
OCCURRING BIOLOGY, AND I CALL
THEM THE HORMONE MILESTONES,
PREGNANCY, MENOPAUSE, AND WE
DON'T EVEN KNOW THE LONG-TERM
EFFECTS AS WOMEN MOVE INTO OLDER
ADULTS, AND IN FACT, PEOPLE WHO
STUDY OLDER AGE NOW HAVE THREE
DIVISIONS LIKE WE DO WITH
ADOLESCENTS, EARLY, MIDDLE AND
LATE, SO WE DON'T UNDERSTAND ALL
OF THOSE MECHANISMS AND WHAT
HAPPENS IF WOMEN MAY HAVE HAD
STABLE OR THAT THEIR DISEASE WAS
MANAGED FAIRLY WELL, BUT THEN WE
HAVE THESE SHIFTS IN HORMONES OR
THINGS BIOLOGICALLY THAT OCCUR
WITH THE DIFFERENT MILESTONES OF
LIFE.
CERTAINLY WE KNOW IN VULNERABLE
PATIENTS POPULATIONS OF WOMEN,
THERE ARE HEAVIER BURDENS FOR
THESE DISEASES, SOME BIOLOGIC
AND SOME WITH ENVIRONMENTAL AND
OTHER CONDITIONS, AND SO I THINK
THE OPPORTUNITY TO LOOK AT THAT
INTERACTION OF BOTH LIFESTYLE
AND OTHER OPPORTUNITIES, IT ALSO
GIVES US A CHANCE TO LOOK AT THE
DIVERSITY OF WOMEN WHICH WE'VE
HEARD IN SEVERAL PRESENTATIONS,
WE ARE NOT A HOMOGENEOUS GROUP,
AND THERE ARE MANY CONDITIONS
THAT WOMEN -- AND I THINK ALSO,
JUST THINK ABOUT THE QUALITY OF
LIFE, I DID LIKE THAT
DR. HIGGINBOTHAM SAID THAT, THE
RATIONALE FOR LEAVING
DEBILITATING BECAUSE THERE ARE
WOMEN WHO DO COPE OR LEARN TO
COPE, AND THEY ARE -- THEIR
QUALITY OF LIFE, THEIR WORKING
CONDITIONS ARE ALL IMPACTED BY
THESE DISEASES THAT I THINK IT'S
IMPORTANT TO LOOK AT THE LIVED
EXPERIENCE, AND SO WE NEED A
VARIETY OF RESEARCH DESIGNS,
BOTH QUALITATIVE AND
QUANTITATIVE, AND TRUE MIXED
METHODS RESEARCH, I THINK WILL
BE REALLY IMPORTANT.
AS WELL AS AS THINK THAT MY
COLLEAGUE DR. NOEL WAS GETTING
AT, IS THERE IS -- PERHAPS SOME
OF THE RESEARCH WILL CARVE OUT
LOOKING -- HOW DO WE BRING
CLINICIANS ALONG WITH WHAT WE
KNOW BOTH NURSING MEDICINE
PUBLIC HEALTH, SOCIAL SERVICES,
TO HELP WOMEN AT LEAST -- YOU
KNOW, WE KNOW A LOT NOW, WE'RE
GOING TO KNOW MORE WHEN THIS
CONCEPT IS PASSED, BUT BRINGING
PEOPLE ALONG, THERE'S AN
OPPORTUNITY FOR EDUCATION BOTH
OF CLINICIANS SO THAT WOMEN
DON'T COME IN TO CLINICAL
SETTINGS AND THEY GET IGNORED,
REAL LIFE DISEASES AND
CONDITIONS.
I'M GOING TO STOP TALKING.
>> THANK YOU VERY MUCH,
DR. SHARPS.
DR. MIELENZ.
>> SURE.
THELMA MIELENZ.
I'LL BE QUICK WITH JUST ONE
QUESTION HERE.
THANK YOU VERY MUCH, DR. TIM
KIN, FOR A GREAT PRESENTATION
OVERVIEW.
AND REALLY JUST HAD ONE
QUESTION, SO YOU HAD THE SLIDE
WITH THE CONCEPTUAL FRAMEWORKS
FROM THE NATIONAL ACADEMIES
REPORT, SORT OF THE THREE
BUCKETS THAT DR. HIGGINBOTHAM
ALSO DISCUSSED.
AND THE FIRST BUCKET IS THE
FEMALE-SPECIFIC AND GYNECOLOGIC
CONDITIONS, AND THEN WE HAVE THE
MIDDLE BUCKET, CHRONIC
CONDITIONS, PREDOMINANTLY IMPACT
OR AFFECT WOMEN DIFFERENTLY AND
OUR LAST BUCKET, ACCUMULATION OF
MULTIPLE CHRONIC CONDITIONS.
SO MY QUESTION IS THAT IF
SOMEONE -- YOU KNOW, SO IF YOU
THINK ABOUT SOMEONE WITH CHRONIC
LOW BACK PAIN WHEN YOU WERE
LOOKING AT THE RAINBOW CHART,
YOU KNOW, AND WE KNOW THAT
THERE'S ONLY $17 SPENT ON
CHRONIC LOW BACK PAIN, SO IF
SOMEONE -- IT WOULD -- SOMEONE
COULD HAVE A CONDITION THAT A
FEMALE-SPECIFIC CONDITION AND
LOW BACK PAIN, BUT IT WOULDN'T
BE RESPONSIVE IF IT WAS JUST
FOCUSED ON LOW BACK PAIN AND
THEN MAYBE SOMETHING IN THE
THIRD BUCKET.
SO THAT'S MY QUESTION.
>> THANKS SO MUCH FOR THAT
QUESTION.
SO I THINK ONE OF THE REASONS TO
FOCUS -- THERE'S TWO REAL
REASONS TO FOCUS ON
FEMALE-SPECIFIC AND GYNECOLOGIC
CONDITIONS.
ONE IS THAT THEY HAVE JUST BEEN
SO UNDERSTUDIED ACROSS THE
BOARD, BUT ALSO IN THE LAST YEAR
AND TWO YEARS, I CAN THINK THERE
ARE JUST SO MANY VALUABLE NEW
WAYS FOR PEOPLE TO BRING WOMEN'S
HEALTH RESEARCH INTO THE NIH.
DR. CLAYTON TALKED ABOUT THE NEW
FRONT DOOR, THE EXECUTIVE ORDER,
AND I THINK THIS IS ONE AREA
THAT EVEN WITH THOSE NEW FUNDING
OPPORTUNITIES, IT'S SOMETIMES
LEFT BEHIND, AND SO THAT WAS
REALLY THE THINKING TO BE ABLE
TO STIMULATE THIS SPECIFIC
RESEARCH AGENDA.
>> GREAT.
THANK YOU, DR. MIELENZ AND
DR. SHARPS FOR YOUR INSIGHTFUL
COMMENTS AND QUESTIONS.
WE'D NOW LIKE TO OPEN UP THE
FLOOR FOR THE REST OF THE
COMMITTEE FOR QUESTIONS OR
COMMENTS.
>> I JUST HAD A QUICK QUESTION.
SO WHEN YOU SAY FEMALE-SPECIFIC
CONDITIONS, GYNECOLOGIC
CONDITIONS, DOES THAT INCLUDE
PREGNANCY-RELATED CONDITIONS AS
WELL OR NOT?
>> SO THIS WAS NOT REALLY
DESIGNED TO BE INCLUSIVE OF
PREGNANCY CONDITIONS.
AGAIN, BECAUSE THERE ARE THESE
NEW OPPORTUNITY FOR PEOPLE TO
SUBMIT PREGNANCY-RELATED
RESEARCH.
IN THE INITIAL DEFINING OF
CHRONIC CONDITIONS FROM HHS,
FROM OUR ACTIVITY, FROM THE
NATIONAL ACADEMIES' ACTIVITY ARE
ALL CONDITIONS THAT LAST FOR
OVER ONE YEAR, AFFECT ACTIVITIES
OF DAILY LIVING AND THEN I LIKE
WHAT THE NATIONAL ACADEMIES HAD
ADDED AT THE END THERE TOO, BUT
I'M NOT GOING TO BE ABLE TO DO
IT OFF THE TOP OF MY HEAD,
BUT -- SO I THINK TO ME, AT
LEAST, PREGNANCY DOESN'T FALL
INTO THAT DEFINITION.
>> I THINK FOR ME, JUST THE
CONCERN WAS IS THAT CLEAR OR NOT
IN THE --
>> I WILL SAY THERE IS AT LEAST
ONE AWARD THAT WE MADE THAT'S
AROUND HOW PREGNANCY CHANGES THE
LIFECOURSE FOR CARDIOVASCULAR
DISEASE, AND SO THAT IS --
CARDIOVASCULAR DISEASE, TO ME
THERE IS THE CHRONIC CONDITION
AND PREGNANCY IS THE
FEMALE-SPECIFIC VARIABLE THAT'S
CHANGING THAT OUT COME.
SO THERE IS -- IT'S NOT LIKE WE
WOULD NOT BE OPEN TO HAVING
INCLUSION OF PREGNANCY IN ANY
GREAT APPLICATION, BUT I THINK
WE WERE REALLY LOOKING AT THINGS
THAT AFFECT WOMEN'S LIVES ON A
LONGER TERM.
>> YES.
>> THANK YOU.
I JUST HAVE SOME CLARIFICATION.
FROM MY EXPERIENCE OF STUDYING
THESE ISSUES IS THAT SOME OF
THESE CHRONIC CONDITIONS DON'T
EXIST BY THEMSELVES, THERE'S
COOCCURRENCE OF CHRONIC
CONDITION.
AND SOMETIMES ONCE YOU HAVE ONE,
OVER TIME, YOU DEVELOP THE NEXT
AND YOU DEVELOP THE NEXT.
AND CAN YOU CLARIFY HOW THIS
CONCEPT WILL ADDRESS THE
OCCURRENCE OF MULTIPLE CHRONIC
CONDITIONS, GIVEN THE WAY NIH
SUPPORTS OR FUNDS DIFFERENT
CONDITIONS?
HOW DOES THIS CONCEPT REALLY
TAKE INTO CONSIDERATION THIS
PHENOMENON OF CO-OCCURRENCE OF
CONDITIONS?
>> SO I MEAN, WE DON'T OBVIOUSLY
HAVE THE LANGUAGE EXACTLY YET,
BUT I WAS HOPEFUL TO BE
INCLUSIVE OF HAVING -- OF
INVITING APPLICATIONS THAT
ARE -- INTERAK WITH OTHER
CONDITIONS AS WELL, AND THAT
REALLY BROADENS I THINK HOW THIS
MAY FIT INTO DIFFERENT IC
PRIORITIES.
WHICH IS I THINK ONE OF THE
GOALS OF THIS.
FOR EXAMPLE, ENDOMETRIOSIS AND
AUTOIMMUNE DISEASE OFTEN
CO-OCCUR IN PATIENTS, AND SO
UNDERSTANDING HOW ENDOMETRIOSIS
AND AUTOIMMUNE DISEASES INTERACT
MAY BE OF INTEREST TO MULTIPLE
ICs, I THINK, AND I HOPE THAT
ANSWERS YOUR QUESTION.
>> YES.
>> JUST A QUICK QUESTION.
I REALLY APPRECIATE THIS
CONCEPT.
IS BEING IN THE CLINICAL
RESEARCH SECTOR, WILL THIS ALSO
SPAN THROUGH BASIC RESEARCH AS
WELL?
THIS OPPORTUNITY?
>> I CERTAINLY HOPE SO.
I DON'T THINK WE WOULD -- WE
WERE PLANNING TO PUT
RESTRICTIONS ON THAT.
>> OKAY.
DO WE HAVE ANY QUESTIONS ONLINE?
OKAY, THANK YOU, EVERYBODY.
I DIDN'T MISS ANYTHING, RIGHT?
OKAY.
THANK YOU, EVERYONE.
SO AT THIS TIME, WE'LL VOTE TO
APPROVE THE FUNDING
OPPORTUNITIES FOR RESEARCH ON
CHRONIC FEMALE-SPECIFIC AND
GYNECOLOGIC CONDITIONS ON THE
CONCEPT CLEARANCE.
PLEASE NOTE THAT ONLY FULL
MEMBERS OF THE ADVISORY
COMMITTEE MAY VOTE, AND IF
YOU'RE AN AD HOC MEMBER OR
OTHERWISE NOT A MEMBER OF ACRWH,
PLEASE REFRAIN FROM VOTING.
SO IS THERE A MOTION ON THE
TABLE TO APPROVE THE FUNDING
OPPORTUNITY TO SUPPORT RESEARCH
ON CHRONIC FEMALE-SPECIFIC AND
GYNECOLOGIC --
>> I WOULD MAKE A MOTION.
>> THANK YOU VERY MUCH.
AND DO WE HAVE A SECOND?
>> I SECOND THE EMOTION.
>> DR. OYEN HAS THE SECOND.
ALL THOSE IN FAVOR, KEEP YOUR
HANDS UP SO THEY CAN BE CLEARLY
VOTED.
THANK YOU, DR. TEMPLETON.
OKAY.
AND THOSE -- DR. JAGSI, THANK
YOU VERY MUCH.
THOSE OF YOU -- ALL OF THOSE
OPPOSED TO THE MOTION, PLEASE
RAISE YOUR HAND NOW.
AND ALL THOSE AB STAIPING FROM M
THE MOTION, PLEASE RAISE YOUR
HANDS.
HAVE THE VOTES BEEN RECORDED?
IF YOU COULD RAISE YOUR HANDS
ONE MORE TIME FOR THOSE WHO ARE
IN FAVOR OF APPROVING THE
CONCEPT CLEARANCE.
AND I BELIEVE WE HAD TWO WHO
WERE VIRTUAL AS WELL.
GREAT.
THANK YOU VERY MUCH, AND THE
CONCEPT CLEARANCE HAS BEEN
ACCEPTED WITH 11 IN FAVOR.
THANK YOU VERY MUCH.
OKAY, LET'S MOVE ON TO OUR NEXT
CONCEPT CLEARANCE.
I WOULD LIKE NOW TO WELCOME OUR
NEXT SPEAKER.
>> GOOD AFTERNOON, EVERYONE.
I WOULD LIKE TO HAPPILY
INTRODUCE TO YOU DR. CAROLYN BON
DAR.
IT'S MY HONOR TO PRESENT TO YOU
A NEW PROGRAM OFFICER OF THE
CAREER SECTION WHO JOINED US
EARLIER THIS YEAR AND LEADS THE
CONTINUITY AND RETENTION
SUPPLEMENT AS WELL AS THE
RE-ENTRY SUPPLEMENTS FOR OUR
SECTION.
IN ADDITION TO SERVING AS
EXECUTIVE SECRETARY FOR THE NIH
WORKING GROUP ON WOMEN IN
BIOMEDICAL CAREERS.
DR. BONDAR IS A NEUROSCIENTIST
BY TRAINING, AND AFTERWARDS HER
POSTDOC TRAINING AT THE DUNCAN
NEUROLOGICAL RESEARCH INSTITUTE
AT THE TEXAS CHILDREN'S
HOSPITAL.
SHE JOINS US FROM THE NATIONAL
INSTITUTE OF NEUROLOGICAL
DISORDERS AND STROKE, WHERE SHE
USED TO WORK, AND SHE IS GOING
TO PRESENT A CONCEPT WHICH WE
HOPE WILL BENEFIT AND STRENGTHEN
THE FEMALE BIOMEDICAL WORKFORCE,
WHICH HAS BEEN MENTIONED SEVERAL
TIMES TODAY.
SO PLEASE WELCOME DR. CAROLYN
BONDAR.
>> THANK YOU SO MUCH FOR ALL
YOUR SUPPORT LEADING UP TO
TODAY, AND ORWH LEADERSHIP AS
WELL.
SO THIS IS A NEW TITLE, NIH
EXCEPTIONAL RESEARCH SCIENTIST
AWARD.
THE OBJECTIVE IS TO ENCOURAGE
DEVELOPMENT OF STABLE RESEARCH
CAREER OPPORTUNITIES FOR
EXCEPTIONAL NON-TENURED
SCIENTISTS POSITIONED TO MAKE
OUTSTANDING CONTRIBUTIONS TO NIH
FUNDED RESEARCH PROGRAMS.
THE NUMBER OF AWARDS IS
CONTINGENT UPON NIH
APPROPRIATIONS.
WE ENVISION A FIVE-YEAR PROJECT
PERIOD AT MOST AND WE'RE LOOKING
FOR VOTE FOR APPROVAL OF THIS
CONCEPT.
SO EFFECTIVELY ADDRESSING AM
ADDRESSINGAMBITIOUS RESEARCH QUS
BECOME INCREASINGLY DEPENDENT ON
COLLABORATIVE APPROACHES THAT
LEVERAGE EXPERTISE AND
INNOVATION FROM MULTIPLE
DISCIPLINES AND TECHNOLOGIES,
AND I THINK IT'S SAFE TO SAY WE
SAW A LOT OF THAT DEMONSTRATED
TODAY.
TEAM SCIENCE IS GREAT.
IT HAS SEVERAL WELL DOCUMENTED
BENEFITS, INCLUDING INCREASED
IMPACT AND INNOVATION, OFTEN
EXTENDING APPLICABILITY TO
DIFFERENT FIELDS AND
DISCIPLINES.
INCREASED PRODUCTIVITY.
MORE PUBLICATIONS AND FASTER
PROGRESS.
IMPROVED PROBLEM SOLVING.
THE COLLECTIVE KNOWLEDGE AND
SKILLS OF A TEAM ENABLES THEM TO
TACKLE PROBLEMS THAT MATE BE TOO
CHALLENGING FOR YOU INDIVIDUAL
RESEARCHERS, BUT THE REALITY OF
TEAM SCIENCE IS THAT NOT
EVERYONE GET TO BE THE P.I.
AND INCREASING RELIANCE ON TEAM
SCIENCE, CORES AND OTHER
SCIENTIFIC SUPPORT FACILITIES
HAS BEEN ACCOMPANIED BY AN
UPTICK IN NON-TENURED RESEARCH
SCIENTIST POSITIONS.
DEMONSTRATING A GROWING NEED FOR
RESEARCH SCIENTISTS WITH
EXTENSIVE RESEARCH EXPERIENCE
THAT CAN PROVIDE CONTINUITY,
STABILITY, AND DETAILED
SCIENTIFIC KNOWLEDGE BEYOND THAT
OF A TRAINEE OR A TECHNICIAN.
SUPPORT FOR NON-TENURED,
NON-TRADITIONAL PI ROLES IS
NEEDED TO BOTH ATTRACT AND
RETAIN EXCEPTIONAL RESEARCH
SCIENTISTS WHO ARE AN
INCREASINGLY VITAL PART OF THE
NIH RESEARCH ENTERPRISE.
THIS CONCEPT AIMS TO FOSTER
WOMEN'S SCIENTIFIC CAREER
DEVELOPMENT AND IS ALIGNED WITH
GOAL 3 OF THE NIH STRATEGIC PLAN
FOCUS ON TRAINING AND EDUCATION.
OUR HOPE IS THAT THIS PROGRAM
WILL HELP RECRUIT, SUPPORT,
RETAIN, AND ADVANCE WOMEN
RESEARCH SCIENTISTS FROM EARLY
CAREERS ON, AND THAT INCLUDES
MID CAREER SCIENTISTS.
BECAUSE WOMEN AND GROUPS
UNDERREPRESENTED IN THE U.S.
SCIENTIFIC RESEARCH ENTERPRISE
ARE OFTEN OVERREPRESENTED IN
NON-TENURE RESEARCH POSITIONS
SUPPORTING THIS CAREER PATH IS
INTEGRAL TO THE NIH STRATEGIC
GOAL OF SUPPORTING A DIVERSE
SCIENTIFIC WORKFORCE, AS WELL AS
THE NIH STRATEGIC PLAN FOR
RESEARCH ON THE HEALTH OF WOMEN.
IT IS ALSO ALIGNED WITH THE NIH
ADVISORY COMMITTEE TO THE
DIRECTOR WORKING GROUP ON
REENVISIONING NIH SUPPORTED
POSTDOCTORAL TRAINING.
IT'S ALIGNED WITH RECOMMENDATION
3.1 IN THIS RECENT RAPPORT WHICH
CALLED FOR NIH-WIDE SUPPORT FOR
A RESEARCH PROFESSIONAL CAREER
TRACK.
THIS REPORT ARGUED THAT
FOSTERING A ROBUST RESEARCH
PROFESSIONAL CAREER TRACK WOULD
IMPROVE THE SUSTAINABILITY AND
HEALTH OF THE BIOMEDICAL SYSTEM
BY EXPANDING THE ACADEMIC JOB
POOL, RETAINING TALENTED
SCIENTIST IN ACADEMIC RESEARCH,
MAINTAINING INSTITUTIONAL
KNOWLEDGE LONG TERM, AND IT
REDUCES BURDENS ON PIs BECAUSE
WE KNOW THESE ROLES ALSO PROVIDE
MENTORSHIP AND TRAINING.
AND IT ALSO HELPS WITH BUILDING
RESEARCH ENTERPRISES AND
CAPACITY.
BUT THIS REPORT ALSO POINTED OUT
THAT THESE POSITIONS DO NOT
CURRENTLY PROVIDE INDIVIDUALS
WITH EITHER THE RECOGNITION NOR
INDEPENDENT FUNDING NEEDED TO
ATTRACT AND RETAIN THE BEST
SCIENTISTS.
THE PURPOSE OF THIS CONCEPT IS
TO IMPROVE SUSTAINABILITY AND
HELP OF THE BIOMEDICAL SYSTEM BY
SUPPORTING EXCEPTIONAL
NON-TENURED, NON-TRADITIONAL
P.I. RESEARCH SCIENTISTS SUCH AS
LABORATORY SCIENTISTS, CORE
SCIENTISTS, AND/OR
CLINICIAN-SCIENTISTS.
THIS SUPPORT IS INTENDED TO
ATTRACT AND RETAIN EXCEPTIONAL
RESEARCH SCIENTISTS BY ENHANCING
THEIR PROFESSIONAL STANDING AND
RECOGNITION.
IMPORTANTLY, THIS WILL PROVIDE
INDIVIDUALS WITH SUFFICIENT
AUTONOMY SO THEY ARE NOT SOLELY
DEPENDENT ON FUNDING BY OTHERS
FOR THEIR CAREER CONTINUITY.
AND BY PROVIDING SALARY AND
TRAVEL SUPPORT, THE INDIVIDUAL
WILL HAVE PROTECTED TIME TO MAKE
A TRANSFORMATIVE IMPACT IN
ADVANCING NIH FUNDED RESEARCH
PROGRAMS.
THIS APPLICATION WILL NOT
PROPOSE NEW RESEARCH, BUT WILL
INSTEAD DESCRIBE RESEARCH
PROGRAMS THAT THE APPLICANT
SUPPORT OR IS LIKELY TO SUPPORT
IN THE FUTURE AND HOW THEIR
PARTICIPATION WILL ENSURE
SUCCESS OF THE PROJECT.
APPLICANTS MUST DEMONSTRATE
RELEVANT SCIENTIFIC SKILLS,
EXPERTISE AND SUCCESS AS
MEASURED AND DOCUMENTED BY
RELEVANT PUBLICATIONS,
CONFERENCE PROCEEDINGS AND
AWARDS.
THE APPLICANT MUST BE A FULL
TIME NON-TENURED RESEARCH
SCIENTIST THAT IS NOT A
TRADITIONAL P.I., AND THE
APPLICATION SHOULD INCLUDE A
CAREER DEVELOPMENT PLAN WITH AN
INSTITUTIONAL LETTER OF
COMMITMENT AND SUPPORTING
LETTERS OF RECOMMENDATION THAT
DEMONSTRATE THE INDIVIDUALS'
LEADERSHIP IN THE FIELD AND
COLLEGIALITY.
THERE ARE A FEW OTHER PROGRAMS
THAT I'D LIKE TO HIGHLIGHT THAT
EXIST FOR SUPPORTING THE
SPECIFIC CAREER TRACK, AND THESE
PROGRAMS HAVE BEEN SUCCESSFUL.
WE CAN LEARN FROM THEM, WE CAN
BUILD ON THEM, AND WE CAN EXPAND
ON THEM.
SO THE FIRST IS THE NATIONAL
CANCER INSTITUTE RESEARCH
SPECIALIST AWARD, WHICH IS AN
R50.
THIS PROVIDES SALARY AND TRAVEL
SUPPORT FOR LABORATORY
SCIENTISTS AND CORE SCIENTISTS
WHICH WAS CREATED IN 2016, AND
THEN IN 2021, THEY ADDED
CLINICIAN-SCIENTISTS.
IT HAS A 19% AWARD RATE, WHICH
IS SIMILAR TO THAT OF YOUR
TYPICAL R01, AND THEY HAVE MADE
OVER 150 AWARDS.
ELIZABETH BARTMAN WAS A RESIP
YANT AT THIS AWARD AT
NORTHWESTERN UNIVERSITY AND I
THINK SHE DEMONSTRATES THE
POTENTIAL SUCCESS OF A PROGRAM
LIKE THIS BETTER THAN I EVER
COULD.
SHE SAYS, FREQUENTLY RESEARCHERS
WANT TO QUICKLY GET THE ANSWER
TO A SPECIFIC QUESTION.
AND ARE LESS INTERESTED IN
INVESTING IN MORE GENERAL
SOLUTIONS.
HAVING THE R50 SPECIALIST AWARD
GAVE ME MORE INDEPENDENCE TO SAY
LET'S DESPOAT SOME TIME TO
SETTING UP A COMPUTATIONAL
INFRASTRUCTURE THAT WE CAN USE
TO ANSWER ANY QUESTION, NOT JUST
THE QUESTION YOU STARTED OUT
WITH.
THAT EMPOWERED ME TO CREATE A
CUE TAITIONAL SYSTEM THAT MANY
SCIENTISTS ACROSS MY UNIVERSITY
ARE NOW USING FOR THEIR STUDIES.
AND LASTLY, I'D LIKE TO
HIGHLIGHT THE MOST RECENT
RESEARCH SOFTWARE ENGINEER
AWARD, WHICH IS ALSO AN R50 THAT
PROVIDES SALARY AND TRAVEL
SUPPORT, SPECIFICALLY FOR
RESEARCH SOFTWARE ENGINEERS, AND
VIRTUALLY ALL OF THE INSTITUTES
AND CENTERS HAVE SIGNED ON TO
THIS ANNOUNCEMENT THAT WAS
PUBLISHED BY THE OFFICE OF DATA
SCIENCE STRATEGY.
AND WITH THAT, I'LL TAKE ANY
QUESTIONS.
THANKS SO MUCH FOR YOUR
ATTENTION.
>> THANK YOU VERY MUCH,
DR. BONDAR.
I WOULD NOW LIKE TO CALL ON TWO
DISCUSSANTS TO DISCUSS THE
CONCEPT.
DRS. IRENE ANINYE AND
DR. KIMBERLY TEMPLETON.
DR. ANINYE, YOU CAN GO FIRST.
>> THANK YOU.
I THINK THIS PARTICULAR
CONCEPT -- I THINK SOMETIMES
THEY FEEL IS LIMITED WHEN
THEY'RE NOT A P.I.
AND THIS IS KIND OF A QUESTION,
KIND OF A COMMENT IF YOU CAN
SPEAK TO IT.
YOUR PLANS FOR OUTREACH TO
ENSURE THAT LIKE THE NON-PROFIT
OR THE SMALL BUSINESSES, AND FOR
PROFIT APPLICANTS ARE REACHED
BECAUSE I THINK THIS IS --
THERE'S A GREAT OPPORTUNITY HERE
FOR RE-ENTRY PARTICULARLY INTO
ACADEMIA AND BEING ABLE TO GROW
THEIR RESEARCH CAREER IN THAT
WAY.
>> WE BELIEVE IT'S A GREAT
OPPORTUNITY FOR RE-ENTRY AS
WELL, AND THE GREAT THING IS,
WE'RE DOING OUTREACH ON OUR
CONTINUITY AND RE-ENTRY
SUPPLEMENTS, AND I THINK WE CAN
DO MORE AND WE CAN INCLUDE THIS
IN THAT OUTREACH THAT WE -- AND
I AGREE WITH YOU, IT NEEDS TO
SPECIFICALLY TARGET NOT JUST THE
BIG UNIVERSITIES, WE NEED TO GO
OUT AND GET PEOPLE ON THE GROUND
FROM ALL -- THE GOAL WOULD BE
THAT WE HAVE PEOPLE ALL OVER THE
U.S. REPRESENTED IN THESE
AWARDS, AND THANK YOU FOR THAT
POINT, AND I AGREE, IT'S REALLY
AN IMPORTANT STRATEGY.
>> I WOULD AGREE, I THINK THIS
IS AN INCREDIBLY IMPORTANT
PROJECT ESPECIALLY FOR WOMEN
RESEARCHERS AS YOU MENTIONED
THEY'RE LESS LIKELY TO BE
TENURED SO THIS IS A WAY TO HELP
SUPPORT THEM IN THEIR CAREERS.
JUST A QUESTION, YOU MENTIONED
IN THE APPLICATION THERE NEEDS
TO BE A CAREER DEVELOPMENT PLAN
AND THERE HAS TO BE A STATEMENT
OF SUPPORT FROM THE INSTITUTION
AND PROTECTED TIME.
WILL THERE BE A WAY TO HELP OR
MECHANISMS RECOMMENDED TO HELP
ENFORCE THAT OR KEEP TRACK OF
THAT?
AS WE KNOW WOMEN, ESPECIALLY
UNDERREPRESENTED MINORITY WOMEN
ARE OFTEN SUBJECT TO A MINORITY
TAX IN WHICH WE'RE ASKED TO DO A
LOT OF OTHER TASKS THAT OTHERS
DON'T THAT DON'T REALLY HELP US
PROGRESS OUR CAREERS MORE FOR
THE GOOD OF THE TEAM OR THE GOOD
OF THE INSTITUTION, IT DOESN'T
NECESSARILY HELP US PLOA SEED IN
OUR CAREERS.
SO MAYBE SOMETHING SUCH AS A
LOCAL MENTOR THAT CAN HELP
SUPPORT THE SCIENTISTS AND HELP
MAYBE INTERVENE IF THEY'RE BEING
ASKED TO DO TOO MANY OTHER
UNRELATED TASKS AND HELP THEM
NAVIGATE THOSE SOMETIMES
CHALLENGING POLITICAL WATERS OR
EVEN SPECIFIC -- SOMETHING
SPECIFICALLY OUTLINED IN TERMS
OF WHAT THAT PROTECTED TIME
MEANS AND THE LIMITATIONS THAT
THEY HAVE ON TRYING TO CRAM
OTHER -- PUT OTHER TASKS INTO AN
ALREADY BUSY SCHEDULE.
THANK YOU.
>> I THINK THAT'S A REALLY
IMPORTANT POINT AND A RECENT
PAPER EVEN DEMONSTRATED THEY HAD
DATA THAT SHOWED WOMEN IN THESE
POSITIONS NOT ONLY ARE THEY
OVERREPRESENTED, BUT THEY TEND
TO MENTOR TWICE AS MANY
INDIVIDUALS AS MEN IN THESE
ROLES.
SO I THINK THAT IS SOMETHING WE
WILL DEFINITELY TAKE INTO
ACCOUNT WHEN WE'RE WRITING THIS,
AND THANK YOU FOR THAT REALLY
IMPORTANT POINT.
>> THANK YOU VERY MUCH,
DR. ANINYE AND DR. TEMPLETON.
I'D NOW LIKE TO OPEN IT UP TO
THE FLOOR TO THE REST OF THE
MEMBERS FOR OTHER QUESTIONS OR
COMMENTS.
DR. ARNOLD?
>> SO MAJOR INTENT HERE IS TO
DIVERSIFY THE WORKFORCE AND
INCLUDE MORE WOMEN.
ARE THERE ANY GENDER
QUALIFICATIONS HERE?
AND DO YOU HAVE DATA FROM THE
OTHER R50 AWARDING AGENCIES ON
WHAT PERCENTAGE OF THE AWARDEES
ARE WOMEN AND MINORITIES?
>> I DON'T HAVE DATA FROM THE
OTHER R50s, BUT WE WILL NOT
RESTRICT THIS TO ONLY WOMEN.
IT'S JUST ALIGNED WITH OUR
STRATEGIC PLAN BECAUSE WE KNOW
THE DATA SUGGESTS THAT WOMEN
RRNT OVER REPRESENTED IN THESE
ROLES.
>> IS THERE ANY CORRECTIVE
MEASURE IF IT DOESN'T ACTUALLY
INCREASE THE NUMBER OF WOMEN?
>> I THINK IT'S -- IT -- IT MORE
ABOUT SUPPORTING THEM IN THESE
ROLES THAN HAVING THEM -- THAT
THIS WOULD BE TARGETED DIRECTLY
TOWARD WOMEN.
>> WOULD IT BE RENEWABLE?
>> YES.
WE HAVE TO DISCUSS THAT, BUT THE
ONE FROM NCI IS RENEWABLE, AND
THEY ACTUALLY FIND THAT PEOPLE
STAY ON THESE AWARDS, THEY SEE
THAT THEY ARE PROGRESSING IN
THEIR CAREERS AND THEY EVEN SEE
AN INCREASE IN THEIR SALARY AS
THEY PROGRESS.
>> DR. JONES AND THEN DR. NOEL.
>> THANK YOU.
I LOVE THE CONCEPT.
I THINK IT GREAT.
I JUST HAVE A COUPLE QUESTIONS.
WHAT IS THE INSTITUTIONAL
COMMITMENT THAT'S GOING TO BE
REQUIRED, IF YOU COULD JUST
EXPAND A LITTLE BIT MORE ABOUT
WHAT THAT LOOKS LIKE AND WHAT
THOSE FUNDING SOURCES NEED TO,
BECAUSE THAT HE COULD BE A
LIMITING FACTOR.
AND THEN WHAT'S THE PERCENT
EFFORT ALLOWED ON THE AWARD?
THANK YOU.
>> SO I THINK PART OF HAVING AN
INSTITUTIONAL LETTER OF
COMMITMENT JUST GOES HAND IN
HAPPENED WITH THE CAREER
DEVELOPMENT PLAN, WITH THE IDP
SAYING NOT ONLY DO I HAVE THIS
CAREER DEVELOPMENT PLAN, BUT MY
INSTITUTION KNOWS ABOUT IT AND
THEY'RE GOING TO SUPPORT ME IN
THIS PLAN, AND I THINK SOMETIMES
NON-TENURED SCIENTISTS GET LOST
IN THE INSTITUTION, AND THEIR
CAREER PATHS AND SUPPORT FOR
WHATEVER IT IS THAT THEIR CAREER
DEVELOPMENT PLAN LOOKS LIKE
ISN'T NECESSARILY A PRIORITY.
SO THIS IS ABOUT BRINGING THAT
AWARENESS TO THE INSTITUTION,
AND HAVING THEM SUPPORT.
>> SO IT'S A PLAN AND NOT LIKE
YOU HAVE TO HAVE 25% OF YOUR
SALARY COVERED FROM NON-FEDERAL
FUNDS?
>> RIGHT, RIGHT.
>> OKAY.
THANK YOU.
AND THEN COULD YOU TALK ABOUT
PERCENT EFFORT OF --
>> SO LOOKING AT -- THAT'S
SOMETHING WE STILL NEED TO
DISCUSS, BUT I WILL SAY THAT THE
NCI AWARD, I BELIEVE, REQUIRES
50% EFFORT.
SO IT'S QUITE A BIT.
AND A LOT OF TIMES -- IT DOESN'T
MEAN THAT THEIR EFFORT IS NOT ON
OTHER GRANTS.
IT JUST MEANS THAT THAT EFFORT,
THAT MAYBE THEY'RE COVERED FOR
ANOTHER GRANT CAN BE SHIFTED TO
THIS AWART, AND THAT THAT COULD
MAYBE BE THE MOVE TO COVER
SUPPLIES OR MATERIALS, BUT IT
SHOULDN'T BE USED TO -- FOR THAT
PERSON.
>> THANK YOU, DR. NOEL.
>> YES, GREAT CONCEPT.
I JUST HAD A FEW QUESTIONS.
WE KNOW THAT THE ACADEMIC WORLD
COULD BE COMPLEX SOMETIMES.
SINCE YOU'RE TARGETING
NON-TENURED SCIENTISTS, IN THE
CAREER PLAN TO FOLLOW UP, WOULD
THAT INCLUDE GOING TO TENURE
TRACK?
BECAUSE SOMETIMES SOME
INSTITUTIONS COULD GO FROM
NON-TENURE TO TENURE TRACK AND
ALSO WITH THE OTHER R50s, LIKE
YOU SHOWED WITH THE CANCER
AGENCY, HAS THERE BEEN SOME
CHANGES WHERE SOMEBODY WENT WITH
THAT AWARD FROM NON-TENURED TO,
FOR EXAMPLE, TENURED TRACK?
>> SO WE WANT TO PROHIBIT THEM
FROM DOING THAT, BUT IT ALSO
COULD BE A CAREER DEVELOPMENT
PLAN, LIKE I WANT TO BECOME THE
LEADER OF THE CORE FACILITY, I
WANT TO BE A SUPERVISOR, RIGHT?
BUT IF SOMEBODY DOES DECIDE TO
BECOME TENURE TRACK, THEN THEY
WOULD HAVE OTHER NIH RESOURCES
OPEN TO THEM, BECAUSE THIS,
THERE AREN'T A LOT.
THIS IS PRETTY MUCH IT FOR
RESEARCH PROFESSIONALS.
AND SO IF THEY DO MOVE TO THE
TENURE CAREER TRACK, THEN THEY
WOULD HAVE OTHER OPPORTUNITIES.
>> QUICK QUESTION ABOUT WOULD
THERE BE A LIMITATION TO CAREER
STAGE?
IS THAT JUST MEANT FOR EARLY
CAREER RESEARCH SCIENTISTS OR IS
IT OPEN TO ALL RESEARCH
SCIENTISTS, REGARDLESS OF HOW
LONG THEY HAVE BEEN IN THAT
POSITION?
>> I'M SORRY, I DIDN'T GET THE
QUESTION.
>> I WAS WONDERING IF THIS IS
GOING TO BE LIMITED TO RESEARCH
SANE TISES DURING THE EARLY
STAGE OF THEIR CAREER OR IT'S
OPEN TO EVERYBODY REGARDLESS OF
HOW LONG THEY HAVE OCCUPIED THAT
POSITION.
>> EVERYBODY.
SO IT NOT GOING TO BE RESTRICTED
JUST TO EARLY STAGE.
>> GREAT.
THANK YOU.
DO WE HAVE ANY QUESTIONS --
PLEASE.
>> IF I HEARD CORRECTLY, YOU
MENTIONED THAT IT CANNOT BE NEW
RESEARCH.
IT'S JUST EXISTING SUPPORT, OR
SUPPORTING SOMETHING IN THE
FUTURE.
HAVE YOU CONSIDERED, IN ORDER TO
STRENGTHEN THEIR BUFFER INTO
BECOMING -- FOR THAT CAREER
ADVANCEMENT, THE OPPORTUNITY TO
SUGGEST A NEW PROJECT EVEN --
THIS SMALL ONE, BECAUSE SOMEBODY
IN THESE ROLE, THEY TONIGHT GET
OPPORTUNITY TO DEVELOP THEIR OWN
IDEAS, THAT WOULD ALLOW THEM TO
MOVE TO THE NEXT POSITION.
>> THAT'S AN INTERESTING POINT.
SO THEY DO DO THAT IN R35s
WHERE THEY DON'T HAVE A SPECIFIC
AIMS PAGE, BUT THEY CAN PROPOSE
NEW -- AND THAT'S SOMETHING THAT
WE CAN DISCUSS AND TAKE INTO
CONSIDERATION.
THANK YOU.
>> GREAT, THANK YOU.
DO WE HAVE ANY QUESTIONS OR
COMMENTS ONLINE?
BASED ON EVERYONE'S FEEDBACK,
LET'S CONTINUE.
SO THANK YOU, EVERYBODY.
AT THIS TIME, WE'LL VOTE ON THE
APPROVAL OF THE NIH EXCEPTIONAL
RESEARCH SCIENTIST AWARD 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,
PLEASE DO NOT VOTE.
IS THERE A MOTION ON THE TABLE
TO APPROVE THE NIH EXCEPTIONAL
RESEARCH SCIENTIST AWARD CONCEPT
CLEARANCE?
>> MOTION TO APPROVE.
>> AND DO I HEAR A SECOND?
>> I SECOND.
>> THANK YOU.
ALL THOSE IN FAVOR OF ACCEPTING
THE MOTION, CAN YOU PLEASE RAISE
YOUR HANDS NOW AND LEAVE THEM UP
WHILE THEY'RE -- IS THAT LONG
ENOUGH OVER THERE?
OKAY.
THANK YOU.
ALL THOSE OPPOSED TO THE
MOTION -- ONLINE?
ALL THOSE OPPOSED TO THE MOTION,
PLEASE RAISE YOUR HANDS NOW.
AND ALL THOSE ABSTAINING FROM
THE MOTION, PLEASE RAISE YOUR
HANDS NOW.
AND HAVE THE VOTES BEEN
RECORDED?
GREAT, THANK YOU.
THE NIH EXCEPTIONAL RESEARCH
SCIENTIST AWARD CONCEPT HAS BEEN
ACCEPTED WITH 11 VOTES IN FAVOR.
SO THANK YOU VERY MUCH.
[APPLAUSE]
SO WE'VE NOW REACHED THE OPEN
DISCUSSION SECTION OF OUR
AFTERNOON.
FIRST OF ALL, THANK YOU ALL FOR
YOUR CONTRIBUTIONS.
THEY'VE BEEN VERY -- THEY'VE
BEEN INVALUABLE.
IF ANY QUESTIONS -- AND IF
ANYONE HAS QUESTIONS THEY WOULD
LIKE TO DISCUSS, PLEASE LET US
KNOW BY RAISING YOUR HANDS.
YES.
>> I JUST WANTED TO MAKE A
COMMENT ABOUT THE AUTOIMMUNE --
I'M SORRY, NOT THE AUTOIMMUNE.
THAT'S ALWAYS IN MY MIND.
THE CHRONIC CONDITIONS, AND I
THINK IT'S A REALLY GREAT
OPPORTUNITY IN ADDRESSING THIS
FOR WOMEN LONG TERM.
ONE OF THE THINGS THAT I WANTED
TO NOTE IS, OF COURSE, WE
RECOGNIZE THAT SOME CONDITIONS
CAN ELEVATE AND BE A LITTLE BIT
MORE POPULAR THAN OTHERS, BUT I
LIKE THE FACT THAT THE APPROACH
WAS VERY INCLUSIVE AND IT
COVERED A LOT OF AREAS, AND SO
JUST TO ENCOURAGE KEEPING THAT
DOOR OPEN SO THAT AS CERTAIN
CONDITIONS MAY RISE TO THE
FOREFRONT, THERE'S -- TO ADDRESS
OTHER CONDITIONS AND MAKE SURE
THEY STILL GET THE ATTENTION
THEY NEED WHEN IT COMES TO
RESEARCH CONDITIONS YOU AND
FUNDING SUPPORT.
>> GREAT, THANK YOU.
THANK YOU VERY MUCH.
YES, DR. NOEL.
>> I HAVE A QUICK QUESTION
REGARDING TO DR. CLAYTON'S
PRESENTATION THIS MORNING.
I THINK IT WAS GREAT YOU
MENTIONED THAT FOR CLINICAL
TRIALS, THERE IS NOW
DISAGGREGATION OF DATA BY SEX
AND IT HAS TO BE PRESENTED AND
BOTH ANALYZED.
MY QUESTION WOULD BE, CAN
SIMILAR REQUIREMENTS BE
IMPLEMENTED WHEN IT COMES TO
PRE-CLINICAL MODELS AND RESEARCH
FUNDING BY NIH THROUGH, FOR
EXAMPLE, THE DATA MANAGEMENT AND
SHARING PLAN THAT THE
INVESTIGATORS HAVE TO SUBMIT AT
THE TIME OF SUBMISSION, IF THAT
COULD BE A REQUIREMENT, THEY
PRESENT THE DATA AS DEAGO DATED.
>> THANKS FOR THAT QUESTION AND
COMMENT, ALEXANDRA.
SO AM CAL PHASE THREE TRIALS,
THE 21ST CENTURY CURES ACT
REQUIRES THAT THE RESULTS BE
DISAGGREGATED BY SEX, GENDER,
RACE -- SEX OR GENDER, RACE AND
ETHNICITY, PUT INTO
CLINICALTRIALS.GOV.
FOR PRE-CLINICAL RESEARCH, THE
SEX AS A BIOLOGICAL VARIABLE
POLICY APPLIES FOR BOTH
PRE-CLINICAL AND CLINICAL
RESEARCH, AND OUR CURRENT
REQUIREMENT IS THAT SEX BE
ACCOUNTED FOR AS A BIOLOGICAL
VARIABLE IN THE RESEARCH DESIGN,
ANALYSIS AND REPORTING.
SO DISAGGREGATING RESULTS BY SEX
IS SOMETHING THAT COULD HAPPEN
IN THE PROGRESS REPORTS BUT
YOU'RE ALSO ASKING ABOUT THE
DATA MANAGEMENT AND SHARING
PLANS AS ANOTHER PATHWAY TO
POTENTIALLY INCLUDE
DISAGGREGATION OF RESULTS
SPECIFICALLY FOR PRE-CLINICAL
STUDIES, AND YOU'RE ASKING
WHETHER THERE'S AN OPPORTUNITY
TO MAKE THAT A REQUIREMENT.
SO THAT'S SOMETHING I'M HAPPY TO
TAKE BACK TO MY COLLEAGUES AT
NIH AND DISCUSS FURTHER.
JUST TO MAKE SURE I
UNDERSTOOD -- THANK YOU.
SO WE GOT A LITTLE OVERSCHEDULED
TODAY, BUT SOMEHOW WE GOT BACK
ALMOST ON TRACK, BUT I KNOW THAT
THERE ARE TRAVEL ARRANGEMENTS
THAT EVERYONE NEEDS, SO I JUST
WANT TO MAKE SURE THAT THERE'S
AN OPPORTUNITY IF THERE'S
ANYTHING ELSE, ANY BURNING
COMMENTS OR QUESTIONS ANYONE
HAS, ON
, IN THE ROOM?
WE USUALLY HAVE A LITTLE BIT
MORE TIME TO TALK AND I USUALLY
GET TO ASK YOU ALL QUESTIONS.
DR. JAGSI PUT HER CAMERA ON.
>> THANK YOU.
>> JUST WANT TO SAY HI?
>> GREAT TO SEE YOU GUYS, THANK
YOU.
>> THANK YOU, RESHMA AND THANK
YOU, KIM, FOR PUTTING YOUR
CAMERA ON AS WELLMENT I DO WANT
TO JUST THANK ALL OF THE
PRESENTERS.
THIS WAS AN INCREDIBLE MEETING.
I WANT TO ECK PRESS MY
APPRECIATION FOR EVERYONE'S
PRESENTATIONS.
I ALSO WANT TO EXPRESS MY
APPRECIATION TO THE ADVISORY
COMMITTEE MEMBERS.
WE DEEPLY APPRECIATE THE WORK
THAT UM DO.
YOU DO.IT DOES COME SPORADICALLD
THERE WILL BE WORK COMING, AND I
WANT TO THANK THOSE MEMBERS WHO
ARE ROTATING OFF.
WE REALLY APPRECIATE YOUR
SERVICE.
IT'S VERY IMPORTANT TO HEAR YOUR
PERSPECTIVES.
AND I'D LIKE TO ALSO ACKNOWLEDGE
THE STAFF OF ORWH AND OUR
CONTRACT SUPPORT AND
COMMUNICATIONS COLLEAGUES,
BECAUSE THEY MAKE THE MEETING
POSSIBLE.
THANK YOU VERY, VERY MUCHMENT
AND SO ON BEHALF OF ORWH, THANK
YOU, EVERYONE, AND WE LOOK
FORWARD TO SEEING YOU AT THE
62ND MEETING OF THE ADVISORY
COMMITTEE ON RESEARCH ON WOMEN'S
HEALTH ON APRIL 8TH, 2025, WHICH
WILL BE A HYBRID MEETING.
SAFE TRAVELS TO EVERYONE HOME.
OUR MEETING IS NOW ADJOURNED.
THANKS, EVERYONE.