Original subtitles

>> 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.