>> GOOD AFTERNOON, EVERYONE, AND
WELCOME TO THE 187TH MEETING OF
THE NICHD ADVISORY COUNCIL.
TODAY'S MEETING IS OPEN TO THE
PUBLIC AND BROADCAST ON THE NIH
VIDEOCAST NETWORK.
TOMORROW, ON DAY TWO OF THE
MEETING, WE WILL HOLD OUR CLOSED
SESSION.
I DO APPRECIATE EVERYONE WHO
THAT'S JOINED US TODAY BY ZOOM
OR ON THE VIDEOCAST.
WITH THIS VIRTUAL MEETING
FORMAT, PLEASE REMEMBER TO
UNMUTE YOURSELF BEFORE SPEAKING
INTO YOUR HOME MICROPHONES AND
STATE YOUR NAME SO THE
TRANSCRIBER AND VIDEOCAST
OBSERVERS WILL KNOW WHO'S
SPEAKING.
AFTER YOU SPEAK, PLEASE BE SURE
TO MUTE YOUR MICROPHONE TO
PREVENT ANY FEEDBACK LOOPS OR
AUDITORY
WELCOME TO ALL OF YOU AND THANK
YOU FOR AGREEING TO PARTICIPATE
AS A MEMBER OF OUR ADVISORY
COUNCIL.
I'D NOW LIKE TO CALL ON THEM TO
BRIEFLY INTRODUCE YOURSELVES.
PLEASE PUT ON YOUR VIDEO AT
LEAST FOR THIS PART OF IT SO
EVERYBODY CAN SEE YOU WHO ARE
AND THEY'LL RECOGNIZE YOU WHEN
WE MEET IN JUNE.
SO THE FIRST PERSON IS
MS. SHANNON COHN.
SHANNON, ARE YOU ON?
SHE'S THE EXECUTIVE DIRECTOR OF
THE ENDO COLLECTIVE IN NEW YORK
AND SHE'S A FILMMAKER.
THE NEXT PERSON IS FROM FRANCIS
COLE KNOWN AS SESH, EMERITUS
PROFESSOR IN THE DIVISION OF
NEWBORN MEDICINE AT THE
WASHINGTON UNIVERSITY SCHOOL OF
MEDICINE.
SO SESH, DO YOU WANT TO SAY JUST
A COUPLE OF THINGS ABOUT
YOURSELF?
>> THANKS, DIANA, VERY MUCH.
IT'S A GREAT PLEASURE FOR ME TO
BE HERE.
I AM A NEONATOLOGIST AT
WASHINGTON UNIVERSITY IN
ST. LOUIS.
MY PRIMARY AREA OF INTEREST HAS
BEEN NOT ONLY TAKING CARE OF
SICK BABIES BUT ALSO IN
LEVERAGING ADVANCED GENOMIC
TECHNOLOGIES FOR MAKING
DIAGNOSES NOT ONLY IN BABIES BUT
IN OLDER CHILDREN AND ADULTS.
THANK YOU VERY MUCH.
>> THANK YOU FOR JOINING US.
THE NEXT PERSON IS DR. EDELLE I
THINK KNOWN AT EDE FIELD-FOTE,
AND SHE IS THE DIRECTOR OF
SPINAL CORD INJURY RESEARCH
PROGRAM AT THE SHEPHERD CENTER
IN ATLANTA, GEORGIA.
DO YOU WANT TO SAY HELLO?
>> THANK YOU SO MUCH.
IT'S A PLEASURE TO BE PART OF
THIS GROUP.
I AM A PHYSICAL THERAPIST BY
CLINICAL TRAINING AND I DID MY
PH.D. WORK AT WASHINGTON
UNIVERSITY IN ST. LOUIS, SO VERY
NICE TO MEET YOU, SESH.
I AM AT THE SHEPHERD CENTER IN
ATLANTA AND I HAVE ACADEMIC
APPOINTMENTS AT EMMY IN THE
DIVISION OF PHYSICAL THERAPY AND
GEORGIA TECH IN THE SCHOOL OF
APPLIED PHYSIOLOGY.
SO WONDERFUL TO JOIN YOU.
>> THANK YOU.
SHANNON IS ON?
SHANNON, WOULD YOU LIKE TO GIVE
A FEW WORDS ABOUT YOUR
BACKGROUND?
THANK YOU FOR JOINING US.
>> YES, HI, EVERYONE.
I HOPE THAT MY CAMERA IS
STARTING TO COME.
YES, I AM A DOCUMENTARY
FILMMAKER, ATTORNEY AND SOCIAL
IMPACT PRODUCER.
I'VE WORKED WITHIN THE WOMEN'S
HEALTH SPACE FOR ABOUT A DECADE
NOW, LOOKING AT A LOT OF HEALTH
CONDITIONS THAT
DISPROPORTIONATELY AFFECT WOMEN
OR AFFECT WOMEN DIFFERENTLY.
MOST RECENTLY ENDOMETRIOSIS,
WHICH I'M SURE MANY OF YOU ARE
FAMILIAR WITH IS REALLY A
MICROCHASM OF SO MANY THINGS
THAT AFFECT WOMEN'S HEALTH,
EVERYTHING FROM GENDER BIAS AND
RACIAL BIAS IN MEDICINE TO
BARRIERS TO CARE WHETHER THEY BE
FINANCIAL, INSTITUTIONAL,
CULTURAL, AND BASICALLY THE
HISTORICAL LACK OF EMPHASIS IN
MEDICAL EDUCATION ON CERTAIN
CONDITIONS THAT AFFECT WOMEN
DISPROPORTIONATELY OR
DIFFERENTLY.
SO IT AN HONOR TO BE HERE.
I'VE WORKED A LOT WITHIN POLICY
IN THE PAST SEVERAL YEARS AND
WITHIN RESEARCH IN THE MEDICAL
EDUCATION SPACE.
SO THANK YOU FOR THE INVITATION
TO JOIN AND IT'S AN HONOR TO BE
HERE.
>> THANK YOU.
THE NEXT PERSON IS
DR. ZHANZHI OR “MIKE” HU IS THE
CO-FOUNDER AND PRESIDENT OF
BINGO BIOTECH IN UNION CITY,
CALIFORNIA.
MIKE, THANK YOU FOR JOINING US.
>> HI, EVERYONE.
MY NAME IS MIKE.
I LIVE IN CALIFORNIA.
I AM A GENOMIC SCIENTIST BY
TRAINING.
I CURRENTLY CONDUCT NEWBORN
SCREENING RESEARCH AFFILIATED
WITH COLUMBIA UNIVERSITY.
I ALSO RUN A NON-PROFIT
ORGANIZATION CALLED PROJECT
GUARDIAN, AND ASIDE FROM THAT, I
AM A FATHER OF TWO CHILDREN
DIAGNOSED WITH A RARE GENETIC
DISEASE, SO I DO CARE FOR
PATIENTS MAYBE NOT IN THE
CLINICAL SETTINGS LIKE MOST OF
YOU.
IT'S AN HONOR TO BE HERE.
THANK YOU FOR REMINDING ME.
>> THANK YOU.
CAYOU I CAN SEE WHAT A BROAD MIN
WE HAVE AND WE'VE SELECTED ALL
OF YOU FOR YOUR EXPERTISE IN
SPECIFIC AREAS.
NEXT IS DR. KEN MANDL, DIRECTOR
OF THE COMPUTATIONAL HEALTH
INFORMATICS PROGRAM AT BOSTON
CHILDREN'S HOSPITAL IN
MASSACHUSETTS.
KEN?
>> THANK YOU, DIANA.
THIS IS WONDERFUL TO BE HERE AS
AN AD HOC COMMITTEE MEMBER TODAY
AND I REALLY LOOK FORWARD TO THE
AGENDA.
I'M ONCE UPON A TIME A PEDIATRIC
EMERGENCY PHYSICIAN, I HAVEN'T
PRACTICED IN A WHILE.
I'VE RUN A PROGRAM CALLED THE
COMPUTATIONAL HEALTH INFORMATICS
PROGRAM AT BOSTON CHILDREN'S
HOSPITAL, WHICH IS A
MULTIDISCIPLINARY
INTERDEPARTMENTAL PROM AND I'M A
PROFESSOR OF PEDIATRICS AND
BIOMEDICAL INFORMATICS AT
HARVARD MEDICAL SCHOOL.
>> THANK YOU, KEN, FOR JOINING
US.
NEXT IS DR. MEGAN MORENO, WHO IS
A PROFESSOR OF PEDIATRICS AT THE
UNIVERSITY OF WISCONSIN-MADISON.
HELLO, MEGAN.
>> HELLO.
THANK YOU SO MUCH FOR THE
INVITATION TO BE HERE.
I AM AN ADOLESCENT MEDICINE
PHYSICIAN AND RESEARCHER AND MY
RESEARCH FOCUSES ON THE
INTERSECTION OF ADOLESCENT
HEALTH AND DIGITAL MEDIA AND I
ALSO SERVE AS A COMEDICAL
DIRECTOR FOR THE AMERICAN
ACADEMY OF PEDIATRICS CENT CENTF
EXCELLENCE ON SOCIAL MEDIA AND
YOUTH MENTAL HEALTH.
>> NEXT IS DR. KISHORE VELLODY,
PROFESSOR OF PEDIATRICS AT THE
UNIVERSITY OF PITTSBURGH IN
PITTSBURGH, PENNSYLVANIA.
WELCOME.
>> HAPPY TO BE HERE AND YES, I
WORK AS A PEDIATRIC HOSPITALIST
FOR ABOUT HALF MY TIME AT THE
CHILDREN'S HOSPITAL OF
PITTSBURGH AND THEN THE OTHER
HALF OF MY TIME, I DIRECT OUR
DOWN SYNDROME CENTER HERE AT
CHILDREN'S HOSPITAL AND MY MAJOR
MOTIVATION IS MY BROTHER WHO HAS
DOWN'S SYNDROME, SO HAPPY TO BE
HERE AND HELP IN THESE EFFORTS.
>> THANK YOU SO MUCH.
AND LAST OF THE EIGHT AD HOC
MEMBER IS DR. MARIANA WOLFNER,
WHO IS THE GOLDWIN SMITH
PROFESSOR OF ARTS AND SCIENCES
IN MOLECULAR BIOLOGY AND
GENETICS AT CORNELL UNIVERSITY
AT THE UPSTATE CAMPUS IN ITHACA,
NEW YORK.
>> THANK YOU SO MUCH.
IT'S A REAL HONOR TO BE HERE.
I'M A BASIC RESEARCHER WITH
EXPERTISE IN GAMETES AND THEIR
BIOLOGY, THE REPRODUCTIVE TRACT,
FERTILIZATION AND EARLY
EMRYOGENESIS.
WE STUDY HOW REPRODUCTIVE TRACT
SECRETIONS PROMOTE THE STABILITY
OF EGGS AND SPERM AND
FERTILIZATION AND HOW A
FERTILIZED EGG INITIATES ITS
DEVELOPMENT.
THANK YOU.
>> THANK YOU.
AND TODAY, IN ADDITION WE HAVE
TWO SUBJECT MATTER EXPERTS
PARTICIPATING IN THIS COUNCIL
MEETING.
I'D LIKE TO CALL ON EACH OF THEM
TO ALSO BRIEFLY INTRODUCE THEY
WILL SEFS.
THEMSELVES.
DR. KIM BREG REIS THE HELPING
HAND OF LOS ANGELES, I HOPE
SHE'S ABLE TO BE ON THE CALL,
YES, I SEE HER THERE.
WE'RE THINKING OF YOU ESPECIALLY
BEING IN LOS ANGELES, BUT THE
HELPING HAND OF LOS ANGELES,
MIRIAM JACOBS CHAIRMAN IN
MATERNAL FETAL MEDICINE AT
CEDARS-SINAI MEDICAL CENTER IN
LOS ANGELES.
WE HOPE YOU ARE SAFE.
DO YOU HAVE A FEW MOMENTS TO
INTRODUCE YOURSELF?
>> I AM SAFE BUT SOME OF MY
PEERS ARE NOT.
SO WE APPRECIATE YOUR PRAYERS
AND WELL WISHES, AND I'M HONORED
TO BE HERE.
I AM VICE CHAIR OF WOMEN'S
HEALTHCARE QUALITY AT
CEDARS-SINAI MEDICAL CENTER,
FELLOWSHIP DIRECTOR, MATERNAL
FETAL MEDICINE.
I'M A HEALTH SERVICES RESEARCHER
ARE A FOCUS ON SAFETY, QUALITY
AND MATERNAL MORBIDITY AND
MORTALITY, AND MEASURING
CHILDBIRTH EXPERIENCES AND
SATISFACTION WITH THEIR CARE.
SO I HOPE THAT I HAVE AN
OPPORTUNITY TO SHARE MY WISDOM
AS NEEDED TODAY.
THANK YOU VERY MUCH FOR THE
INVITATION.
>> WE ESPECIALLY THANK YOU GIVEN
THE CIRCUMSTANCES FOR JOINING US
TODAY.
LAST BUT BY NO MEANS LEAST IS
DR. JAMES ALSO KNOWN AS JIM RO
BERTS, PROFESSOR IN THE
DEPARTMENT OF O OBSTETRICS AND
GYNECOLOGY AND REPRODUCTIVE
SCIENCES AT THE UNIVERSITY OF
PITTSBURGH.
>> I'M JIM ROBERTS, OBSTETRICIAN
GYNECOLOGIST MATERNAL FETAL
MEDICINE SPECIALIST BY TRAINING
FOR THE LAST 30 YEARS I'VE DONE
RESEARCH PRIMARILY AND PRIMARILY
ON ADVERSE OUTCOMES IN
PARTICULAR PRE-ECLAMPSIA FOR THE
LAST SEVERAL YEARS, I'VE BEEN
WORKING WITH A GROUP CALLED THE
GLOBAL -- COLLABORATION AND IN
THAT GROUP WE TRY TO FACILITATE
COLLABORATION BY DATA SHARING,
INTELLECT SHARING AND
IDENTIFYING PROBLEMS THAT WE
THINK DESERVE THE ATTENTION OF
THE RESEARCH GROUP AT LARGE.
IT'S REAL EXCITING TO BE HERE.
I'VE READ ALL MY NOTES AND ALL
THE MINUTES AND YOU CAN ASK ME
ANYTHING.
I'M READY.
THANK YOU.
>> THANK YOU FOR JOINING US.
WE APPRECIATE YOUR DEDICATION.
NOW I'LL TURN THE MEETING OVER
TO DR. REBEKAH RASOOLY, OUR
DIRECTOR OF THE DIVISION OF
EXTRAMURAL ACTIVITIES.
>> THANK YOU AND GOOD AFTERNOON,
EVERYONE.
ON THE COUNCILMEMBER WEBSITE,
YOU SHOULD ALL HAVE READ, AGREED
TO AND SIGNED THE
CONFIDENTIALITY AND
NON-DISCLOSURE RULES FOR SPECIAL
GOVERNMENT EMPLOYEES BEFORE
EVALUATING ANY NIH GRANT
APPLICATIONS.
FOR THOSE OF YOU WHO ARE NOT
OFFICIAL COUNCILMEMBERS YET OR
AD HOCS AND ARE SUBJECT MATTER
EXPERTS, WE SENT YOU A SEPARATE
CONFIDENTIALITY AND
NON-DISCLOSURE FORM WHICH YOU
HAVE ALL SIGNED.
ALSO REMEMBER, PLEASE, THAT YOU
CANNOT SERVE ON ANY NIH PEER
REVIEW PANEL WHILE YOU SERVE AS
A COUNCILMEMBER.
AND YOU CANNOT PROVIDE SECOND
LEVEL REVIEW OF COUNCIL FOR ANY
APPLICATION IN WHICH YOU
PARTICIPATED IN THE FIRST LEVEL
OF PEER REVIEW.
IT IS NIH'S POLICY THAT A SINGLE
INDIVIDUAL CANNOT SERVE ON BOTH
THE FIRST AND SECOND LEVELS OF
PEER REVIEW.
NOW TURNING OUR ATTENTION TO THE
COUNCIL MINUTES.
THE MINUTES FOR THE
SEPTEMBER 4TH AND 5TH, 2024
MEETING WERE POSTED ON THE
COUNCILMEMBER WEBSITE FOR YOUR
CONSIDERATION LAST WEEK.
SO I'M GOING TO ASK NOW FOR A
MOTION TO APPROVE THOSE MINUTES
AND THEN ONCE I HAVE THAT MOTION
AND A SECOND, I'M GOING TO ASK
YOU TO VOTE AND JUST TO REMIND
YOU THAT THE WAY TO VOTE ON ZOOM
IS TO GO TO THE REACTIONS BUTTON
ON THE BOTTOM AND SEARCH FOR THE
GREEN CIRCLE FOR YES OR THE RED
CIRCLE FOR NO OR SIMPLY RAISE
YOUR HAND IF YOU WANT TO
ABSTAIN.
ALL RIGHT?
SO LET'S GO AHEAD AND LET'S GET
A MOTION TO APPROVE THE MINUTES.
>> SO MOVED.
>> AND THAT WAS?
>> MARCELLE CEDARS.
>> DR. CEDARS.
AND A SECOND?
>> SECOND.
>> ALL RIGHT.
AND ALL IN FAVOR, PLEASE VOTE
YES OR NO.
DR. AIZER, DID YOU HAVE A
QUESTION OR IS THAT ABSTAINING?
>> NO, NO QUESTION.
SORRY.
>> OH, OKAY.
ALL RIGHT, THANK YOU VERY MUCH.
ALSO WANTED TO ASK ALL THE
COUNCILMEMBERS AND AD HOCS TO
PLEASE NOTE ON YOUR AGENDA, THE
FUTURE MEETING DATES.
AS YOU CAN SEE, WE RESERVE THESE
DATES WAY IN ADVANCE AND WE LOOK
FORWARD TO HAVING THESE COUNCIL
MEETINGS AND HAVING ALL OF YOU
AT THE MEETINGS.
SO THE NEXT MEETING COMING UP
WILL BE IN PERSON.
IT WILL BE ON JUNE 9 AND 10 OF
THIS YEAR.
FOLLOWED BY ANOTHER IN-PERSON
MEETING ON SEPTEMBER 9TH AND
10TH AND THEN THE DATES FOR THE
2026 MEETINGS ARE ALSO THERE AND
I'LL ASK YOU AGAIN TO PLEASE
NOTE YOUR CALENDARS.
NOW I'LL TURN THE MEETING BACK
TO DR. BIANCHI.
>> THANK YOU SO MUCH, REBECCA.
. MYPRESENTATION IS GOING TO BE
ABOUT 30 MINUTES AND HOPEFULLY
THINGS WORK OUT WELL, I'LL LEAVE
15 MINUTES FOR QUESTIONS.
FEEL FREE TO PUT YOUR QUESTIONS
IN THE CHAT BOX BUT I CAN'T
SIMULTANEOUSLY SEE THE CHAT BOX
AND MY SLIDES.
SO WE WILL ADDRESS -- FEEL FREE
TO WRITE THEM IN AS YOU THINK OF
THEM OR WE'LL HOLD THEM FOR THE
END, BUT WE'LL GO BACK TO THE
CHAT BOX WHEN I'M DONE.
SO WE HAVE A LITTLE PRESIDENTIAL
TRANSITION COMING UP NEXT WEEK
SO I'LL BE TALKING BRIEFLY ABOUT
THAT AND SOME CONGRESSIONAL
UPDATE.
I'D THEN LIKE TO HIGHLIGHT SOME
RESEARCH COMING OUT OF NICHD,
AND THEN THE UPDATES ON THE
STRATEGIC PLAN, AS WELL AS OTHER
COMMENTS RELATED TO WOMEN'S
HEALTH RESEARCH AND PEAD
TRICKERY PEDIATRICRESEARCH AND H
SOME STAFF UPDATES AT NICHD.
SO IF YOU WERE FOLLOWING THE
NEWS BEFORE THE HOLIDAYS, YOU
KNOW THAT WE NOW HAVE A
CONTINUING RESOLUTION UNTIL
MARCH 14TH.
WE ARE NEARLY HALFWAY THROUGH
THE FISCAL YEAR THAT BEGAN ON
OCTOBER 1ST.
YOU'LL PROBABLY HEAR MORE ABOUT
THIS FROM ALEXIS CLARKE IN THE
AFTERNOON, WHEN WE HAVE A
CONTINUING RESOLUTION, WE ARE
ESSENTIALLY OP RATING ON A
FANTASIZED FLAT BUDGET.
WE DON'T REALLY KNOW HOW MUCH
MONEY WE WILL HAVE IN THE BUDGET
UNTIL WE ACTUALLY HAVE A BUDGET,
SO FOR THAT REASON, WE ARE
UNUSUALLY CONSERVATIVE.
IT DOES MAKE ADMINISTRATION AND
PROCESSING OF ALL OF THE GRANTS
THAT HAVE BEEN APPROVED FOR
FUNDING MUCH HARDER TO DO
BECAUSE ESSENTIALLY OUR
WONDERFUL STAFF ARE WORKING
TWICE AS HARD IN THE SECOND HALF
OF THE YEAR BECAUSE THERE ARE A
LOT OF THINGS THAT THEY COULD
NOT PROCESS AND FUND BECAUSE WE
DIDN'T HAVE A BUDGET, IF THAT
MAKES SENSE.
IN ADDITION, AS OF NEXT WEEK,
NEXT MONDAY AT NOON, WE WILL
HAVE A NEW PRESIDENT AND A NEW
ADMINISTRATION.
THIS IS A PROCESS THAT OCCURS
FREQUENTLY, AND THE NIH IS VERY
EXPERIENCED IN HOW TO HANDLE A
TRANSITION AND ACTUALLY FOR
MONTHS, OUR STAFF HAVE BEEN
WORKING ON TRANSITION DOCUMENTS
REGARDLESS OF WHO WON THE
ELECTION.
SO WE ARE SOMEWHAT PREPARED.
HERE IS THE ANTICIPATED
CONGRESSIONAL TIMELINE THAT
AFFECTS ALL OF US.
SO WE ARE NOW AT JANUARY 13TH,
SO THE ELECTION RESULTS HAVE
BEEN CERTIFIED.
THERE IS A NEW SPEAKER OF THE
HOUSE.
INAUGURATION DAY IS NEXT MONDAY
AND IF YOU'RE IN THE D.C. AREA,
YOU CAN SEE ALL THE PARADE
CONSTRUCTION AND THE VIEWING
BOXES ARE ALL DONE.
AND THEN ONCE THE INCOMING
PRESIDENT IS INAUGURATED, THE
CONFIRMATION PROCESS WILL BEGIN.
SO HOW DO WE CONFIRM A NEW NIH
DIRECTOR?
WELL, IT'S NOT US, IT'S CONGRESS
THAT'S CONFIRMING THE NEW NIH
DIRECTOR.
SO THE PRESIDENT HAS ANNOUNCED
THE NOMINATION OF WHO HE WOULD
LIKE TO HAVE AS THE NEW NIH
DIRECTOR.
DR. BERTAGNOLLI WILL BE REQUIRED
BY LEGISLATION TO SUBMIT HER
LETTER OF RESIGNATION AND SHE
WILL BE MOVING ON TO ANOTHER
POSITION.
THE PRESIDENT HAS ANNOUNCED THAT
DR. JAY BHATTACHARYA IS HIS
PREFERRED NOMINEE, AND
DR. BHATTACHARYA HAS BEEN
MEETING WITH MEMBERS OF THE
SENATE.
FOLLOWING THAT, THERE IS A
SENATE HEALTH COMMITTEE HEARING,
SO THE SENATE HEALTH COMMITTEE
IS THE HEALTH EDUCATION LABOR
AND PENSIONS COMMITTEE THAT
GIVES THE BUDGET TO THE NIH.
THEN THERE'S A VOTE, AND THEN
EVENTUALLY THE NOMINEE IS
BROUGHT TO THE FULL SENATE FOR
CONFIRMATION.
WE DO NOT KNOW WHAT THE TIMING
OF THIS PROCESS WILL BE.
IN TERMS OF RESEARCH HIGHLIGHTS,
I WOULD LIKE TO ENCOURAGE ALL OF
YOU TO VISIT THE NICHD'S 2024
SELECTED RESEARCH ADVANCES
SHOWCASE, WHICH HAS A LINK ON MY
BLOG SITE AS WELL AS IF YOU JUST
USE THIS LANGUAGE, YOU WILL FIND
IT.
HERE ARE SOME OF THE TOPICS THAT
WE HAVE HIGHLIGHTED IN OUR
SHOWCASE OF WHAT WE'VE DONE IN
THE PAST YEAR LOOKING AT WOMEN'S
HEALTH, IMPROVING POSTPARTUM
HEALTH OUTCOMES, ADVANCING FETAL
AND NEONATAL HEALTH, IMPROVING
CARE FOR PEDIATRIC INJURY,
ADVANCING CHILD AND ADOLESCENT
HEALTH, TREATING AND
UNDERSTANDING PEDIATRIC
INFECTIONS, ADDRESSING HEALTH
DISPARITIES FOR PEOPLE WITH
DISABILITIES, EXPANDING RESEARCH
ON INTELLECTUAL AND
DEVELOPMENTAL DISABILITIES,
ADVANCING MEDICAL REHABILITATION
RESEARCH AND DISCOVERING HOW
CELLS ARE PROGRAMMED.
SO WITHIN EACH OF THESE TOPICS,
WE'VE HIGHLIGHTED SOME OF THE
MOST IMPACTFUL RESEARCH THAT WAS
PUBLISHED DURING THE PAST YEAR.
NOW THOSE OF YOU WHO ARE NEW AD
HOC MEMBERS KNOW THAT WE HAVE
BEEN PRESENTING PERIODIC UPDATES
TO YOU ON OUR REFRESHED
STRATEGIC PLAN.
WE LAST CAME OUT WITH THE
STRATEGIC PLAN IN 2020, AND IN
THE 21ST CENTURY CURES ACT, IT
WAS STATED THAT ALL OF THE
INSTITUTES AND CENTERS MUST HAVE
A NEW STRATEGIC PLAN EVERY FIVE
YEARS.
SO OUR PLAN IS ALMOST FINALIZED.
WE'RE HOPEFUL THAT YOU ARE GOING
TO SEE IT ONLINE IN THE NEXT FEW
WEEKS.
WE'RE JUST UNDERGOING THE LAST
BIT OF PROOFREADING AND MAKING
SURE THAT EVERYTHING, ALL THE
I'S HAVE DOTS AND THE T'S ARE
CROSSED.
BUT IF YOU'VE LOOKED AT OUR
PRIOR STRATEGIC PLAN, THE
OVERALL SCIENTIFIC GOALS REMAIN
THE SAME.
SO WE HAD FIVE SCIENTIFIC GOALS
THAT IN A VERY BROAD SENSE ARE
REFLECTING THE SCIENCE THAT WE
FUND.
WHAT WE DID, HOWEVER, WAS UPDATE
THE OBJECTIVES WITHIN THESE
GOALS, AND WE'VE ALSO
SIGNIFICANTLY UPDATED THE
SCIENTIFIC STEWARDSHIP AND
MANAGEMENT AND ACCOUNTABILITY
GOALS.
WE REALLY APPRECIATE COUNCIL'S
FEEDBACK THROUGHOUT THE PROCESS
AT THE PREVIOUS COUNCIL MEETING.
COUNCILMEMBERS ARE A NUMBER OF
VERY IMPORTANT COMMENTS, AND YOU
WILL SEE THAT WE LISTEN TO YOU
AND WE INTEGRATED THE
INFORMATION INTO THE EXT STRATEC
PLAN.
I'D ALSO LIKE TO ACKNOWLEDGE THE
INTERNAL STAFF MEMBERS,
VIRTUALLY EVERYONE PLAYED A ROLE
IN UPDATING THE STRATEGIC PLAN.
MANY, MANY EYES HAVE LOOKED AT
IT, AND WE THINK IT A TERRIFIC
ROAD MAP FOR THE NEXT FIVE
YEARS.
SO JUST TO HIGHLIGHT SOME OF THE
NEW OBJECTIVES.
SO THE FIRST GOAL IS
UNDERSTANDING THE MOLECULAR,
CELLULAR AND STRUCTURAL BASIS OF
DEVELOPMENT.
OUR NEW OBJECTIVES TAKE
ADVANTAGE OF NEW TECHNOLOGIES IN
THIS RESEARCH AREA, INCLUDING
ARTIFICIAL INTELLIGENCE.
THE COUNCIL IN OUR LAST MEETING
MADE A VERY STRONG POINT ABOUT
THE FACT THAT WE WEREN'T SAYING
ENOUGH ABOUT TECHNOLOGIES SUCH
AS A.I. THAT ARE ALREADY
CHANGING EVERYTHING THAT WE DO.
THEME TWO IS ADVANCING
GYNECOLOGIC, ANDRO LOGLOGIC AND
REPRODUCTIVE HEALTH.
THERE'S A STRONGER EMPHASIS IN
THIS PLAN ON GYNECOLOGIC
CONDITIONS AND CONTRACEPTION.
THE PRIOR STRATEGIC PLAN FOCUSED
MORE ON DEVELOPING FUNDAMENTAL
KNOWLEDGE IN REPRODUCTIVE
HEALTH, AND WE HAVE MADE GREAT
STRIDES IN THIS AREA.
WHAT THE 2025 PLAN DOES IS IT
SHIFTS A FOCUS TO TRANSLATION
AND INTERVENTIONS TO IMPROVE
GYNECOLOGIC HEALTH.
THE THIRD THEME IS SETTING THE
FOUNDATION FOR HEALTHY
PREGNANCIES AND LIFELONG
WELLNESS.
THE IMPROVE INITIATIVE
IMPLEMENTING A MATERNAL HEALTH
AND PREGNANCY OUTCOMES VISION
FOR EVERYONE AND OTHER PROGRAMS
HAVE BROUGHT INCREASED FOCUS ON
MATERNAL INTERVENTIONS TO ALIGN
WITH COMMUNITY NEEDS AND
PREFERENCES.
THE 2025 PLAN CONTINUES ITS
FOCUS ON MATERNAL AND INFANT
HEALTH BUT BUILDS ON THE
SUCCESSES AND THE FACT THAT WE
HAVE REALLY REACHED ACROSS THE
COUNTRY TO WORK ON REDUCING
MATERNAL MORTALITY.
IN ADDITION, THE LAST FIVE
YEARS, WE HAVE HAD A SHARPENED
FOCUS ON PREVENTION OF
STILLBIRTH, AND ALSO CONTINUING
OUR ACTIVITIES IN PREVENTION OF
PRETERM BIRTH AS WELL AS
TREATING PREMATURE BABIES AND
PREVENTING SOME OF THE
DEVASTATING CONDITIONS THAT THEY
ACQUIRE AS A RESULT OF BEING
PREMATURE.
THE NEXT THEME HAVE IMPROVING
CHILD AND ADOLESCENT HEALTH AND
THE TRANSITION TO ADULTHOOD.
WE'VE ADDED A FOCUS ON PEDIATRIC
PRIMARY CARE AND INTERVENTIONS
TO IMPROVE THE HEALTH OF
CHILDREN OF ALL AGES.
WE FELT THAT THAT WAS NOT
EMPHASIZED ENOUGH IN THE 2020
PLAN.
WE HAVE RETAPED THE FOCUS ON
ADOLESCENT TRANSITION TO
ADULTHOOD, AS WELL AS
ADOLESCENTS IN GENERAL, BUILDING
ON WHAT WAS STARTED IN THE 2020
PLAN WHEN IT WAS RECOGNIZED THAT
THERE WAS NEVER ANYTHING
MENTIONED ABOUT ADOLESCENTS IN
PREVIOUS PLANS ACROSS NIH.
AND THE LAST THEME, THEME FIVE,
IS FOSTERING SAFE AND EFFECTIVE
THERAPEUTICS AND DEVICES FOR
PREGNANT WOMEN, LACTATING WOMEN,
CHILDREN AND PEOPLE WITH
DISABILITIES.
WE ARE BUILDING ON THE PRGLAC
IMPLEMENTATION PLAN, SO PRGLAC
IS AN ACRONYM FOR RESEARCH ON
PREGNANT AND LACTATING WOMEN.
THE WORKSHOP AND THE STUDY OF
HOW TO IMPROVE RESEARCH IN
PREGNANT AND LACTATING WOMEN WAS
PART OF THE 21ST CENTURY CURES
ACT.
WE'VE MADE OUR RECOMMENDATIONS,
WE'VE IMPLEMENTED MANY OF THEM,
BUT WE ARE CONTINUING TO
IMPLEMENT ALL OF THEM, AS WELL
AS INCREASING OUR ACTIVITIES IN
THE M PRINT, THE MATERNAL AND
PEDIATRIC PRECISION IN
THERAPEUTICS PROGRAM,
RECOGNIZING THAT THERE IS A
SERIOUS NEED FOR MORE DATA ON
HOW PREGNANT PEOPLE AND
LACTATING PEOPLE METABOLIZE
THERAPEUTICS WITH THE GOAL BEING
THAT PEOPLE SHOULD BE TAKING
MEDICATIONS THEY NEED FOR THEIR
OWN HEALTH AND REASSURING THEM
ABOUT ITS SAFETY IN THEIR
FETUSES AND INFANTS.
THIS PARTICULAR THEME EMPHASIZES
COLLABORATIONS WITH OTHER NIH
INSTITUTES AND CENTERS AND OTHER
ORGANIZATIONS WHICH HISTORICALLY
HAVE BEEN SUCCESSFUL.
I THINK THE AREA THAT GENERATED
A LOT OF DISCUSSION WAS OUR
ASPIRATIONAL GOALS.
SO SOME OF THE ASPIRATIONAL
GOALS.
SO THE ASPIRATIONAL GOALS ARE
AREAS IN WHICH WE REALLY WANT TO
PUSH OURSELVES, AND WE NEED TO
DO MORE.
AND THE QUESTION WAS HOW AND
WHAT SHOULD WE FOCUS ON.
SO SOME OF THE GOALS THAT WERE
RETAINED INCLUDED DIAGNOSING,
PREVENTING AND TREATING
ENDOMETRIOSIS, AS WELL AS LIMB
REGENERATION.
WE ADDED SOME EXCITING NEW GOALS
RELATED TO IMPROVING FUNCTION
FOR PEOPLE WITH NEUROLOGICAL
IMPAIRMENT, ALSO USING MENSTRUAL
EFFLUENT AND SEMEN TO DIAGNOSE
ORDERS AND CONDITIONS.
CONTINUING BUT EXPANDING AN
EMPHASIS ON PREVENTING
PREECLAMPSIA AND POSTPARTUM
HEMORRHAGE AS MAJOR FACTORS IN
MATERNAL MORTALITY.
IMPROVING THE QUALITY OF HUMAN
MILK, AND AGAIN LOOKING FOR HOW
MEDICATIONS ARE METABOLIZED AND
APPEAR IN HUMAN MILK.
PREVENTION OF STILLBIRTH.
IMPROVING THE HEALTH OF PRETERM
INFANTS AS I ALREADY SAID.
PEDIATRIC WELL CARE AND PRIMARY
CARE, AND THEN EXPANDING GENE
THERAPY FOR THE FUTURE.
WE TALKED LAST TIME IN OUR
STRATEGIC PLAN ABOUT THE WARP
AND THE WEFT, SO THINKING ABOUT
CROSS-CUTTING THEMES.
PREVIOUSLY THE ONES THAT ARE
NON-BOLDED ARE OR WERE IN THE
2020 STRATEGIC PLAN.
THESE INCLUDE REDUCING HEALTH
DISPARITIES, IMPROVING HEALTH
EQUITY.
FOCUSING ON PREVENTION.
FOCUSING ON INFECTIOUS DISEASE,
WHICH WAS VERY PRESCIENT BECAUSE
OUR LAST STRATEGIC PLAN CAME OUT
IN THE FALL OF 2019, NOT KNOWING
THERE WAS A PANDEMIC TO COME.
NUTRITION, AND GLOBAL HEALTH.
WE'VE ADDED ADD ADVANTAGED
TECHNOLOGIES AND ARTIFICIAL
INTELLIGENCE, AGAIN A NOD TO THE
COUNCIL'S RECOMMENDATIONS, AND
ALTHOUGH WE DID TALK ABOUT
EXPANDING AND IMPROVING RESEARCH
TRAINING AND CAREER DEVELOPMENT,
NOW WE HAVE MADE IT A SPECIFIC
CROSS-CUTTING THEME.
SO NOW WE'RE GOING TO TURN TO
WOMEN'S HEALTH.
SOME OR MANY OF YOU MAY BE AWARE
THAT THE NATIONAL ACADE NATIONAF
SCIENCE, ENGINEERING AND
MEDICINE ALSO KNOWN AS NASEM
RELEASED A REPORT IN DECEMBER ON
THEIR ASSESSMENT ABOUT NIH'S
COMMITMENT TO WOMEN'S HEALTH
RESEARCH.
THE NASEM REPORT STATED THAT
FEMALE-SPECIFIC CONDITIONS SUCH
AS FIBROIDS, ENDOMETRIOSIS, PCOS
AND ASPECTS OF THE MENOPAUSE
TRANSITION ARE NOT WITHIN THE
PURVIEW OF ANY SPECIFIC IC OR
INSTITUTE AND CENTER.
THEY APPARENTLY DID NOT KNOW
THAT IT IS ACTUALLY LEGISLATED
THAT NICHD IS THE HO HOME FOR TS
TYPE OF RESEARCH.
HERE'S THE PASSAGE FROM 42 UCS
285G SECTION 448, THE PURPOSE OF
NICHD.
IT PROVIDED LEGISLATIVE
AUTHORITY FOR NICHD TO CONDUCT
AND SUPPORT RESEARCH, TRAINING,
HEALTH INFORMATION DISSEMINATION
AND OTHER PROGRAMS WITH RESPECT
TO GYNECOLOGIC HEALTH.
IT ACTUALLY COMES FIRST.
NICHD IS THE HOME FOR
FEMALE-SPECIFIC CONDITIONS.
RELATED TO THE REPRODUCTIVE
AREA.
ALSO MATERNAL HEALTH, CHILD
HEALTH, IP INTELLECTUAL
DISABILITIES, HUMAN GROWTH AND
DEVELOPMENT INCLUDING PRENATAL
DEVELOPMENT, POPULATION RESEARCH
AND SPECIAL HEALTH PROBLEMS AND
REQUIREMENTS IN MOTHERS AND
CHILDREN.
THOSE OF YOU WHO ARE NEW TO THE
COUNCIL, THIS IS THE PARAGRAPH
THAT YOU NEED TO FOCUS ON.
THIS IS WHAT WE DO.
THIS IS THE RESEARCH THAT WE
FUND.
WELL, WE AND OTHERS WERE VERY
CONCERNED THAT THE REPORT
SOMEWHAT MISSTATED THE FACTS AND
DR. BERTAGNOLLI CAME OUT WITH A
STATEMENT, AND I'M GOING TO
QUOTE WHAT SHE WROTE.
WHILE THE REPORT PROVIDES
THOUGHTFUL RECOMMENDATIONS ON
HOW NIH CAN EXPAND ITS RESEARCH
EFFORTS, IT DOES NOT ACKNOWLEDGE
THE FULL BREADTH OF NIH'S
EXTENSIVE WORK ON WOMEN'S HEALTH
RESEARCH.
IT OMITS THE KEY CONGRESSIONAL
LANGUAGE THAT ESTABLISHES THE
STUDY OF GYNECOLOGICAL AND
PREGNANCY-RELATED CONDITIONS AT
NIH'S EUNICE KENNEDY SHRIVER
NATIONAL INSTITUTE OF CHILD
HEALTH AND HUMAN DEVELOPMENT,
AND IT UNDERSTATES THE
SIGNIFICANCE OF ONGOING WOMEN'S
HEALTH INITIATIVES SUPPORTED BY
NICHD AND OTHER NIH INSTITUTES.
NICHD'S INVESTMENT IN
GYNECOLOGIC HEALTH RESEARCH IS
ACTIVE AND GROWING, AS YOU WILL
LEARN FROM LISTENING TO OUR
COUNCIL PRESENTATIONS.
THE GYNECOLOGIC HEALTH AND
DISEASE BRANCH IN DER, THE
DIVISION OF EXTRAMURAL RESEARCH,
MAINTAINS A RESEARCH PORTFOLIO
IN ENDOMETRIOSIS, UTERINE
FIBROIDS, PELVIC FLOOR
DISORDERS, POLYCYSTIC OVARY
SYNDROME, AND GYNECOLOGIC PAIN.
I REALIZED THAT THIS IS ACTUALLY
NOT THE RIGHT SLIDE PRESENTATION
BECAUSE WE HAD IN THE SLIDE
PRESENTATION A HIGHLIGHT FROM
THE JAMA PAPER THAT WOMEN'S
HEALTH ON NIH'S COMMITMENT TO
WOMEN'S HEALTH RESEARCH, WHICH
APPEARED JANUARY 6TH, I BELIEVE,
SO WE CAN GET THAT PUBLICATION
TO COUNCILMEMBERS.
I DID HAVE A SLIDE IN HERE IN
THE MOST RECENT VERSION, WHICH
TALKED ABOUT THE SPECIFIC PAPER
WHICH WAS WRITTEN MONTHS AGO,
AND REALLY DOES SOMEWHAT CORRECT
THE RECORD SHOWING NIH'S STRONG
COMMITMENT TO WOMEN'S HEALTH
RESEARCH ACROSS THE BOARD.
SO AN EXAMPLE OF THIS IS THE
RADX TECH ACT ENDO CHALLENGE.
I TALKED ABOUT THIS AT THE
PREVIOUS COUNCIL MEETING.
ACT ENDO STANDS FOR ADVANCING
CURES AND THERAPIES AND ENDING
ENDOMETRIOSIS DIAGNOSTIC DELAYS.
AND WE HAVE PARTNERED WITH NIBIB
TO LEVERAGE THE RAPID
ACCELERATION OF DIAGNOSTICS
TECHNOLOGY INNOVATION FUNNEL
PROGRAM TO ACCELERATE THE TIME
TO DIAGNOSIS OF ENDOMETRIOSIS,
ELIMINATE INVASIVE TECHNIQUES,
AND IMPROVE ACCESSIBILITY.
WE HAD A PRO BUST RES ROBUST REO
PHASE ONE SUBMISSION.
SOME OF THE DIAGNOSTIC
APPROACHES THAT WERE IN
THIBLECATIONS INCLUDED IMPROVED
IMAGING, STOOL-BASED BIOMARKERS,
MEASURING GI MOTILITY, EXAMINING
MENSTRUAL EFFLUENT FOR DNA, RNA
AND BIOMARKERS.
THE NEXT STEPS INCLUDE THE PITCH
EVENT, AND THEN THE TECHNOLOGY
DEVELOPMENT SPRINT.
THE FINAL WINNERS WILL BE
ANNOUNCED IN MARCH OF 2026.
SO THIS IS ONE OF MANY PROJECTS
THAT WE ARE FUNDING RELATED TO
ENDOMETRIOSIS.
NOW PEDIATRIC RESEARCH INCLUDES,
WE DO NOT FUND ALL OF PEDIATRIC
RESEARCH ACROSS NIH, BUT WE HAVE
RESEARCH THAT IS FUNDED WITHIN
MANY OF THE BRANCHES THAT ARE
LISTED HERE.
THESE ARE OUR DIVISION OF
EXTRAMURAL RESEARCH BRANCHES.
SO WE'RE JUST GOING TO HIGHLIGHT
A FEW THINGS.
BLESS YOU.
SO SIMILAR TO THE ANALYSIS OF
OBSTETRIC AND GYNECOLOGY
RESEARCH AS WELL AS WOMEN'S
HEALTH RESEARCH FUNDED BY NIH,
THERE'S A SIMILAR STUDY GOING ON
IN PARALLEL BY THE NATIONAL
ACADEMIES THAT WAS REQUIRED BY
FISCAL YEAR 24 APPROPRIATIONS
REPORT LANGUAGE.
THE FIRST MEETING OF THE
COMMITTEE MEMBERS WAS HELD ON
DECEMBER 5TH AND 6TH.
WE HAD A COUPLE OF STAFF FROM
NICHD WHO PROVIDED THE SPONSOR
BRIEFING.
I UNFORTUNATELY HAD A CONFLICT
SO I COULDN'T BE THERE.
IT IS AN OPEN MEETING.
PRESENTATION SLIDES AND VIDEO OF
THE MEETING ARE AVAILABLE.
THE INTENT IS, OVER THE NEXT 18
MONTHS, THAT NASEM WILL HOLD
THREE TO FIVE PUBLIC MEETINGS,
AND THEY WILL PRODUCE A FINAL
REPORT WITH RECOMMENDATIONS
ANTICIPATED IN EARLY 2026.
THERE IS A WEBPAGE FOR THIS
COMMITTEE.
AND THE COMMITTEE IS TASKED WITH
EXAMINING THE CURRENT NIH
PEDIATRIC RESEARCH PORTFOLIO AND
STRUCTURE, INCLUDING THE METHODS
AND RATIONALE INVOLVED IN
CATEGORIZING PROJECTS AS
PEDIATRICS RESEARCH USING THE
RESEARCH CONDITION AND DISEASE
CATEGORIZATION PROCESS, ALSO
KNOWN AS RCDC.
HOW PEDIATRIC COMPONENTS HAVE
BEEN INCLUDED OR EXCLUDED FROM
LARGER NIH-WIDE INITIATIVES,
SUCH AS HELPING TO END ADDICTION
LONG TERM, CLIMATE CHANGE AND
HEALTH, ET CETERA.
WHAT ARE THE STRUCTURAL OR
PROCESS IMPEDIMENTS TO PEDIATRIC
RESEARCH APPLICANTS?
HOW PEDIATRIC RESEARCH PRIORITY
ARE ESTABLISHED WITHIN AND
ACROSS ICs.
HOW PEDIATRIC RESEARCH ACTIVITY
IS COORDINATED ACROSS NIH ICs.
AND WAYS IN WHICH THE NIH
CLINICAL CENTER, THE LARGEST
RESEARCH HOSPITAL IN THE WORLD,
COULD BE USED TO ADVANCE
INNOVATIVE PEDIATRIC RESEARCH.
SO THAT IS ONGOING.
THERE HAVE BEEN DATA REQUESTS.
ALTHOUGH WE ARE INDEPENDENT OF
THEIR EVALUATION PROCESS, WE ARE
VERY ACTIVE IN PROVIDING THEM
WHATEVER INFORMATION THEY NEED.
ANOTHER HIGHLIGHT, THIS SHOULD
HAVE BEEN PART OF THE
CONGRESSIONAL INFORMATION, BUT
GABRIELLA MILLER KIDS FIRST
RESEARCH ACT 2.0 WAS SIGNED INTO
LAW.
THOSE OF YOU WHO WERE FOLLOWING
THE BUDGET DISCUSSIONS JUST
PRIOR TO CHRISTMAS MIGHT HAVE
HEARD THE HEADLINE THAT THE KIDS
CANCER RESEARCH WAS NOT INCLUDED
IN THE BILL.
SO AFTER THE CONTINUING
RESOLUTION WAS SIGNED, THIS BILL
WAS SEPARATED OUT AND NOW
THERE'S A NEW LAW THAT IS
EXTENDING THE GABRIELLA MILLER
PROGRAM THROUGH 2028.
AND IT FOSTERS COLLABORATIVE
RESEARCH ACROSS NIH TO UNCOVER
THE CAUSES OF CHILDHOOD CANCERS
AND STRUCTURAL CONGENITAL
ANOMALIES.
SUPPORTS DATA SHARING WITHIN THE
PEDIATRIC RESEARCH COMMUNITY,
AND IN 2024 ALONE, 12,759
SAMPLES WERE SEQUENCED.
11,204 GENOMES WERE DELIVERED TO
INVESTIGATORS, AND 6,101 GENOMES
WERE RELEASED ON THE KIDS FIRST
DATA RESOURCE CENTER PORTAL.
THE KIDS FIRST PORTAL HAS OVER
6,500 USERS FROM OVER 50
COUNTRIES WHO CAN ACCESS
CLINICAL DATA, PHENOTYPES, AND
GENETIC VARIANTS.
THE NEXT STEPS INCLUDE ENHANCING
THE PROGRAM'S INTEROPERABILITY
EFFORTS, RELEASING MOST OF THE
DATA TO THE PORTAL IN A SINGLE
YEAR, AND CONTINUING MULTIMODAL
DATA INTEGRATION IN THE KIDS
FIRST PORTAL.
SO TYPICALLY, WE END THE
DIRECTOR'S PRESENTATION WITH
SOME STAFF UPDATES.
I'M HAPPY TO SAY THAT WE HAVE
NOW RECRUITED TWO BRANCH CHIEFS.
THE FIRST ONE IS LINDY THAKER,
OUR CHIEF OF THE PEDIATRIC
GROWTH AND NUTRITION BRANCH.
SHE IS A PEDIATRICIAN AND A
GLOBAL NUTRITION EXPERT.
SHE'S DONE PRIOR WORK WITH USAID
SUPPORTING FOOD AND NUTRITION
PROGRAMS.
SHE RECEIVED HER MD FROM THE
INDIANA UNIVERSITY SCHOOL OF
MEDICINE, HER MASTERS IN PUBLIC
HEALTH FROM THE JOHNS HOPKINS
BLOOMBERG SCHOOL OF PUBLIC
HEALTH, AND SHE DID HER
PEDIATRIC NUTRITION FELLOWSHIP
AT THE CHILDREN'S HOSPITAL OF
PHILADELPHIA.
SHE IS CREDENTIALED AS A
PHYSICIAN NUTRITION SPECIALIST.
SO WE'D LIKE TO WELCOME LINDY.
AND THE NEXT PERSON, OUR MOST
REASON HIRE IS DR. MARANKE
KOSTER, WHO IS THE NEW CHIEF OF
THE DEVELOPMENTAL BIOLOGY AND
CONGENITAL ANOMALIES BRANCH.
SHE RECEIVED HER PH.D. IN
DEVELOPMENTAL BIOLOGY FROM
BAYLOR COLLEGE OF MEDICINE.
HER RESEARCH HAS FOCUSED ON
INVESTIGATING MECHANISMS THAT
CONTROL NORMAL DEVELOPMENT OF
ECTODERMAL TISSUES AS WELL AS
PATHOLOGICAL MECHANISMS THAT
LEAD TO ECTODERMAL DYSPLASIAS.
SHE'S PREVIOUSLY HELD FACULTY
POSITIONS AT THE UNIVERSITY OF
COLORADO, AND MOST RECENTLY THE
BRODY SCHOOL OF MEDICINE AT EAST
CAROLINA UNIVERSITY.
SO WELCOME.
SO THAT SUMMARIZES MY
PRESENTATION.
I KNOW I MENTIONED THIS LAST
TIME BUT I WANT OUR NEW AD HOC
MEMBERS TO BE AWARE OF THE FACT
THAT WE HAVE NEW WOMEN'S HEALTH
RESEARCH FACT SHEET IF YOU SCAN
THE QR CODE, YOU CAN GET ACCESS
TO THESE.
THEY ARE PUBLICLY AVAILABLE.
PLEASE FEEL FREE TO DISTRIBUTE
THEM AS YOU SEE FIT.
THEY ARE ESSENTIALLY ONE PAGERS,
GIVING A LITTLE BIT OF
INFORMATION ABOUT THE CONDITION
AND THEN OUR RESEARCH EFFORTS AS
WELL AS OUR RECENT SUCCESSES.
SO AGAIN, WE'D LIKE PEOPLE TO BE
AWARE OF WHAT NICHD ACTUALLY
DOES FUND.
SO WITH THAT, I AM JUST ABOUT ON
TIME.
SO WE'RE RUNNING A LITTLE AHEAD
ACTUALLY.
SO I HAVE PLENTY OF TIME TO TAKE
QUESTIONS SO I'M GOING TO PUT ON
MY GLASSES AND HOPEFULLY I CAN
SEE THE CHAT BOX.
LET'S SEE.
SO SESH VERY HELPFULLY, I
BELIEVE, PUT IN THE JAMA
PUBLICATION SO YOU CAN DOWNLOAD
THAT.
I'M NOT SURE WHAT SLIDESET
ACTUALLY GOT TRANSMITTED.
THERE WERE SLIGHT DIFFERENCES IN
THE FINAL VERSION, BUT -- HAPPY
TO TAKE QUESTIONS.
SO SESH IS ASKING, GREAT SUMMARY
OF NICHD'S GREAT CONTRIBUTIONS
WILL PREGNANCY RELATED
CONDITIONS BE INCLUDED IN THE
PEDIATRIC NASEM REPORT?
IS THAT --
>> THAT'S CORRECT.
BECAUSE IN MY OPINION,
LITERALLY, I MAY BE OUT OF LINE
HERE, WHAT HAPPENS IN THE 270
DAYS OF GESTATION INFLUENCE
SIGNIFICANTLY PEDIATRIC
OUTCOMES, AND I WONDER WHETHER
THOSE PEDIATRIC OUT COME
INFLUENCES WILL BE INCLUDED IN
FUNDING OPPORTUNITIES THAT ARE
EXAMINED BY THE NASEM COMMITTEE.
>> SO THAT IS A GREAT QUESTION.
IF YOU READ THE NASEM REPORT ON
WOMEN'S HEALTH, YOU WOULD SEE
THAT THAT COMMITTEE THOUGHT THAT
NICHD ONLY FUNDED
PREGNANCY-RELATED RESEARCH AND A
LITTLE BIT ON INFANTS AS WELL.
THE COMMITTEE THAT IS EXAMINING
PEDIATRIC RESEARCH, THEY HAVE
BEEN ASKING QUESTIONS ABOUT THE
UPPER END OF PEDIATRICS, LIKE AT
WHAT AGE DOES PEDIATRICS END.
I HAVEN'T SEEN QUITE AS MUCH ON
THE PREGNANCY-RELATED ASPECTS,
BUT THE COMMITTEE MEMBERS ARE
PUBLIC, AND I BELIEVE YOU WOULD
BE FREE TO ASK THEM DIRECTLY.
>> I'LL SPEAK TO PHYLLIS.
I'LL EMAIL PHYLLIS.
>> PERFECT.
THANK YOU.
PEPE.
>> THANK YOU, DR. BIANCHI, FOR
AN EXCELLENT REPORT.
I HAD A COUPLE OF COMMENTS
REGARDING THE REPORT FROM
NATIONAL ACADEMIES.
I WONDER IF -- I THINK IT'S
IMPORTANT TO -- SOMETHING THAT
THEY CAN PUBLISH BECAUSE PEOPLE
CONSULT THOSE REPORTS AND WE
DON'T WANT TO PROPAGATE THIS
ERROR ON THE REPORT.
I DON'T KNOW IF ANYBODY IS A
MEMBER OF THE NATIONAL ACADEMIES
HERE IN THIS MEETING BECAUSE
THAT WOULD BE ONE WAY TO
INITIATE THAT CORRECTION.
MY SECOND COMMENT IS REGARDING
THE WORKFORCE DEVELOPMENT, THE
PROMOTING COLLABORATION,
PARTICULARLY GLOBAL
COLLABORATIONS, IS THE TOPIC OF
TEAM SCIENCE.
AND WE DO A LOT OF THAT, BUT
IT'S REALLY IMPORTANT TO
EMPHASIZE THAT FROM WORKFORCE
DEVELOPMENT ALL THE WAY TO
THROUGHOUT THE INSTITUTE.
THANK YOU.
>> THANK YOU.
AND WE DO NOTE THE IMPORTANCE OF
TEAM SCIENCE.
AT THE RECENT LEADERSHIP FORUM
WHICH IS AN ANNUAL EVENT HELD
AMONGST ALL THE DIRECTORS OF THE
INSTITUTES AND CENTERS, THERE
WAS A BIG DISCUSSION ON TEAM
SCIENCE AND HOW TO APPROPRIATELY
RECOGNIZE PEOPLE, ESPECIALLY
EARLY STAGE INVESTIGATORS WHO
ARE PARTICIPATING IN TEAM
SCIENCE, SO THIS IS VERY MUCH ON
THE MINDSET OF EVERYONE.
IN TERMS OF THE NASEM REPORT,
IT'S A LITTLE BIT OF A SENSITIVE
TOPIC.
WE HAVE -- NOT WE.
NICHD BUT NIH.
I ONLY HIGHLIGHTED THE THINGS
THAT WERE QUITE INACCURATE IN
TERMS OF NICHD.
THERE WERE OTHER INACCURACIES AS
WELL.
SO WHAT HAPPENED WAS NIH PUT
TOGETHER A LIST AND WE ARE
SUPPOSED TO MEET WITH MEMBERS OF
THE COMMITTEE TO DISCUSS HOW
THEY CAN CORRECT SOME OF THESE.
WHAT WAS RELEASED PUBLICLY, I
BELIEVE WAS A DRAFT.
SO THERE STILL IS AN OPPORTUNITY
TO CREATE SOME OF THESE
INACCURACIES.
THE BOTTOM LINE WAS ONE OF THEIR
BIGGEST RECOMMENDATIONS WAS THE
FORMATION OF A SEPARATE WOMEN'S
HEALTH INSTITUTE BECAUSE SOME OF
THESE TOPICS WERE NOT THE
PURVIEW OF EXISTING INSTITUTES.
SO ANYWAY.
BUT IT IS SOMETHING THAT WE ARE
WORKING ON.
LET'S PUT IT THAT WAY.
>> THANK YOU.
>> CYNTHIA, DO YOU WANT TO COME
OFF MUTE AND --
>> YES, THANK YOU.
THANKS, DR. BIANCHI.
YOUR COMMENTS WERE REALLY
WONDERFUL AND ON POINT AND
REALLY HELPING US TO UNDERSTAND
THIS TIME OF TRANSITION.
SO IN LOOKING AT YOUR REFRESH
FOR THE STRATEGIC PLAN,
INCREDIBLY PLEASED THAT MANY OF
THE PRIORITIES ARE REALLY
FOCUSING ON WOMEN'S HEALTH AND
PREGNANCY HEALTH.
AND WHILE THERE ARE EXCELLENT
OB-GYNs FROM A VARIETY, I
THINK, OF FOCUSES WITHIN NICHD,
I WONDER IF THERE IS ANY PLANS
TO MAYBE ENHANCE THAT BOTH ON
COUNCIL AS WE HAD LOST A COUPLE
OB-GYNs ROTATING OFF AND ALSO
JUST WITHIN NICHD.
THANK YOU FOR YOUR COMMENTS.
>> THANK YOU, CYNTHIA, FOR YOUR
QUESTION.
SO I BELIEVE WE HAVE THREE
OB-GYNs.
I MAY BE MISSING SOMEONE, BUT
YOURSELF, IGNA AND MARCEL.
IF I'M MISSING ANYONE, PLEASE
LET ME KNOW.
WE ARE ALWAYS VERY COGNIZANT OF
THE NEED TO BALANCE NOT ONLY
PEOPLE WITH EXPERTISE FROM A
MEDICAL AND SCIENTIFIC
PERSPECTIVE, BUT WE ALSO HAVE
SHANNON, WHO IS A MAJOR ADVOCATE
FOR MORE RESEARCH ON GYNECOLOGIC
HEALTH.
SO AGAIN WHEN YOU SEE THE
REFRESHED STRATEGIC PLAN, YOU
WILL SEE THE STRATEGIC PRIORITY
ARE HEAVILY FOCUSED ON WOMEN'S
HEALTH, INCLUDING GYNECOLOGIC
HEALTH AS WELL AS MATERNAL
HEALTH.
AGAIN, IT'S IN THAT PARAGRAPH
AND WE FEEL THAT THAT IS OUR
MISSION.
FOR SURE.
PART OF OUR MISSION.
>> THANK YOU.
>> MIMI, DID YOU WANT TO --
>> LOOKING AT THE STATISTIC THAT
YOU GAVE REGARDING HOW MANY
GENOMES HAVE BEEN COMPLETELY
SEQUENCED THROUGH THE KIDS FIRST
PROGRAM, IT LOOKED LIKE ONLY 50%
OF THOSE GENOMES, THOUGH, WERE
AVAILABLE THROUGH THEIR PORTAL,
WILL THEY BE COMING OUT TO BE
AVAILABLE TO THE OTHER 50% IN
THE FUTURE OR HOW IS THAT BEING
TON?
>> I DDONE?
>> I DON'T WANT TO SPEAK OUT OF
TURN BECAUSE I'M NOT DIRECTLY IN
CHARGE OF THAT PROGRAM BUT,
AGAIN, THAT IS THEIR PLAN.
EVENTUALLY, EVERYTHING WILL BE
RELEASED PUBLICLY.
KEN HAD HIS HAND UP?
>> GREAT.
WHAT A FANTASTIC PRESENTATION.
I'LL JUST POINT OUT SOMETHING
THAT I'M SURE YOU'VE CONSIDERED,
BUT IT WOULD BE NICE PERHAPS IN
THE CORRECTION OF THE NATIONAL
ACADEMIES REPORT THAT INSTEAD
THEY RECOMMEND ADDITIONAL
FUNDING TO NICHD TO ADDRESS
THESE ISSUES.
RATHER THAN CREATION OF THE NEW
INS TAUGHT.
I'M SURE THERE ARE A NUMBER OF
US ON THE CALL WHO WOULD BE MORE
THAN PLEASED TO SUPPORT THAT
SUGGESTION.
AND I ALSO WONDER IF WITHIN THE
AGENDA PRIORITIES AND THE
STRATEGIC PLAN PRIORITIES, IF
THERE IS AN OPPORTUNITY TO
ADDRESS THE -- WITHOUT QUESTION
IMPACT OF PEDIATRIC WORKFORCE
ISSUES, AND AT THE INTERSECTION
OF LARGE SCALE CHANGES IN HOW
CARE IS DELIVERED, IS THE
INTERSECTION WITH ARTIFICIAL
INTELLIGENCE.
WOULD LOVE TO SEE NICHD
OPERATING AT THAT CROSSROADS.
>> THANK YOU, KEN.
SO FIRST OF ALL, WITH REGARD TO
A SOLUTION TO INCREASING WOMEN'S
HEALTH RESEARCH BEING INCREASING
FUNDING TO THE INSTITUTES AND
CENTERS AND OFFICES THAT PERFORM
THIS TYPE OF RESEARCH, FANTASTIC
IDEA.
ALL OF YOU HAVE THE ABILITY TO
SPEAK TO YOUR REPRESENTATIVES IN
CONGRESS ABOUT THAT.
THERE IS THE SCIENTIFIC
MANAGEMENT REVIEW BOARD THAT IS
MEETING TO TALK ABOUT WAYS TO
ADDRESS AREAS THAT ARE UNDER
DISCUSSION WITH REGARD TO THE
FUTURE OF NIH, AND I DON'T HAVE
ANYTHING MORE TO SAY ABOUT THAT
RIGHT NOW.
YOU SAW -- SO THAT'S ONE THING.
THE PEDIATRIC WORKFORCE ISSUE IS
A SIGNIFICANT ONE.
WE'RE VERY AWARE OF THAT, BOTH
AT THE CLINICAL TRAINING LEVEL,
NOT ONLY IN GENERAL PEDIATRICS
BUT SUBSPECIALTIES, AND WE ARE
WORKING SEPARATELY WITH
AMSPEDAC, WITH THE PEDIATRIC
MEDICAL DEPARTMENT CHAIRS TO
GIVE THEM INFORMATION AND WORK
WITH THEM TO PROVIDE EXTRA
FUNDING SLOTS, WHICH IDEALLY
SHOULD NOT COME EXCLUSIVELY FROM
NICHD, AND WE WILL BE PRESENTING
TO THEM LATER THIS MONTH WITH
SOME DATA THAT HAVE BEEN
REFRESHED TO SHOW EXACTLY HOW
MUCH EACH INSTITUTE IS
COMMITTING TOWARDS TRAINING OF
PEDIATRICIANS, AND WE'RE GOING
TO TRY TO DO WHATEVER WE CAN TO
ADDRESS THIS ISSUE.
BUT A LOT OF THE PROBLEMS AS YOU
KNOW HAVE TO DO WITH SALARY
DISCREPANCIES FOR PEDIATRIC
RESIDENTS AND OTHER ISSUES.
HOWEVER, AS I BELIEVE I'VE
MENTIONED IN THE LAST COUNCIL
MEETING, WE HAVE INCREASED OUR
SUPPORT OF THE LOAN REPAYMENT
PROGRAM FOR PEDIATRIC
RESEARCHERS BY 28% IN FISCAL
YEAR 24 OVER FISCAL YEE 23.
FISCAL YEAR 23.IS THAT CORRECT?
THAT WAS ON THE SLIDE.
I'M JUST CHECKING ON THE YEARS.
WE'RE IN FISCAL YEAR 25 NOW, SO
IT WAS FISCAL YEAR 24 OVER 23,
WE SIGNIFICANTLY INCREASED OUR
COMMITMENT TO THE PEDIATRIC LOAN
REPAYMENT PROGRAM.
SO WE'RE DOING WHAT WE CAN WITH
NOT HAVING A BUDGET, FOR
EXAMPLE.
I JUST WANT TO MAKE NOTE OF THE
FACT THAT REBEKAH RASOOLY PUT A
NOTE IN THE CHAT BOX THAT WE
HAVE ONE ADDITIONAL OB-GYN WHO
WILL BE JOINING US AT THE JUNE
COUNCIL.
SO THAT WILL MAKE FOUR OUT OF
18, SO ROUGHLY A QUARTER OF OUR
COUNCILMEMBERS WILL BE
OB-GYNs.
WE'RE DOING WELL ON TIMING.
YOU WILL GET MORE TIME IN YOUR
BREAK UNLESS YOU HAVE QUESTIONS.
HAPPY TO ANSWER QUESTIONS.
OKAY.
WELL, THANK YOU FOR YOUR
QUESTIONS.
OF COURSE WE'RE ALWAYS AVAILABLE
TO ANSWER YOUR QUESTIONS OFFLINE
AS WELL.
AND WITH THAT, WE ARE GOING TO
GO TO THE BUDGET REPORT.
SO I WOULD NOW LIKE TO ADDRESS
MS. ALEXIS CLARKE, WHO'S GOING
TO GIVE AN OVERVIEW OF THE NICHD
BUDGET.
I CAN SAY THAT WHEN I WAS ON THE
ADVISORY COUNCIL, ALEXIS' TALK
WAS THE SINGLE MOST INFORMATIVE
TALK I HEARD IN MY FOUR YEARS ON
COUNCIL.
SO SHE IS THE NICHD BUDGET
OFFICER, AND SHE IS CHIEF OF THE
FINANCIAL MANAGEMENT BRANCH, AND
SHE DOES AN OUTSTANDING JOB.
I DON'T THINK PEOPLE REALIZE HOW
COMPLEX IT IS, ESPECIALLY WHEN
THERE'S A CONTINUING RESOLUTION.
BECAUSE SHE AND HER STAFF HAVE
TO MAKE MULTIPLE CONTINGENCIES,
AND IMAGINE WHAT IT WOULD BE
LIKE IF WE GOT A 5% REDUCTION IN
OUR BUDGET, IF WE HAD A FLAT
BUDGET, IF WE GOT A 1% INCREASE,
ET CETERA.
SO WITH THAT, I'D LIKE TO HEAD
OVER TO ALEXIS.
THANK YOU.
>> WELL, NO PRESSURE, I GUESS,
ON HAVING THE MOST IMPACTFUL
PRESENTATION.
I'M TRYING TO FIGURE OUT THE
CAMERA HERE.
I DON'T REALLY LIKE THAT.
I'M GOING TO TRY TURNING ON THE
CAMERA ON MY COMPUTER.
WE'LL SEE IF THAT WORKS A LITTLE
BETTER.
THERE WE GO.
IS THAT BETTER FOR FOLKS?
YOU CAN SEE ME NOW, NOT JUST
FROM THE SIDE?
OKAY.
SO THANK YOU FOR HAVING ME
TODAY.
AS DR. BIANCHI SAID, MY NAME IS
ALEXIS CLARK.
I AM WHAT WE CALL THE BUDGET
OFFICER HERE AT NICHD.
I'M THE CHIEF OF THE FINANCIAL
MANAGEMENT BRANCH.
TODAY I'M GOING TO TALK TO YOU A
LITTLE ABOUT OUR FEDERAL BUDGET
PROCESS, THE PROCESS WE DO HERE
AT NIH, AND WE'LL TALK WITH
SOMETABOUTSOMETHING WE CALL MECM
TABLE, SOME OF OUR MANDATED
PROGRAMS, HOW WE DEVELOP OUR
GRANT BUDGETS AND PAYLINES, SOME
OF OUR SETASIDES AND THINGS LIKE
THAT.
REALLY WHAT I'M GOING TO TALK TO
YOU ABOUT IS SORT OF HOW WE
CREATE THE PLANS FOR A FISCAL
YEAR, HOW WE FIGURE OUT HOW MUCH
MONEY WE HAVE FOR NEW AWARDS,
AND HOW WE TRY TO GIVE
INFORMATION TO LEADERSHIP SO
THEY CAN MAKE DECISIONS ABOUT
FUNDING FOR GRANTS.
SO AGENCIES BEGIN DEVELOPING
THEIR BUDGETS OVER A YEAR IN
ADVANCE AT THE BEGINNING OF THE
FISCAL YEAR, SO WE HAVE BEEN
WORKING ON THE FY 26 PRESIDENT'S
BUDGET.
IT CONTAINS PROPOSALS TO
CONGRESS WHICH THEY MAY OR MAY
NOT ADOPT.
THIS PRESIDENT'S BUDGET IS
CALLED OUR CONGRESSIONAL
JUSTIFICATION.
AND IT'S TRADITIONALLY SEPTEMBEO
CONGRESS ON THE FIRST MONDAY IN
FEBRUARY.
THAT WILL NOT HAPPEN THIS YEAR
DUE TO HAVING A PRESIDENTIAL
TRANSITION.
THERE'S JUST NOT ENOUGH TIME.
SO THE CJ WILL BE A LITTLE
DELAYED THIS YEAR.
THAT PUTS PRESSURE ON CONGRESS
TO HOLD THEIR APPROPRIATION
HEARINGS IN THE SPRING.
AND THE COMMITTEES WILL WORK ON
MAKING LEGISLATIVE DECISIONS IN
THE SUMMER.
THE GOAL, OF COURSE, IS FOR
CONGRESS TO APPROPRIATE FUNDS BY
OCTOBER 1ST.
I WILL SAY I'VE BEEN WORKING IN
THE GOVERNMENT MORE THAN 25
YEARS.
I'VE ONLY SEEN THAT HAPPEN MAYBE
ONCE.
SO WHEN THAT DOES NOT HAPPEN, AS
DR. BIANCHI MENTIONED BEFORE, WE
HAVE WHAT WE CALL A CONTINUING
RESOLUTION OR A CR.
WE ARE CURRENTLY UNDER A CR
UNTIL MARCH 14TH, AND THE AMOUNT
OF THE CR IS BASICALLY BASED ON
A PERCENTAGE OF WHAT WAS
APPROPRIATED IN THE PREVIOUS
FISCAL YEAR.
SO WE'LL SWITCH, WE'LL TALK A
LITTLE BIT NOW ABOUT BUDGET AT
NIH.
SO AT NIH, THERE IS AN OFFICE OF
BUDGET WITHIN THE NIH OFFICE OF
THE DIRECTOR.
THAT OFFICE HAS A LOT OF THE
CENTRALIZED NIH BUDGET
INFORMATION.
THEY COORDINATE INFORMATION FROM
ALL OF THE 27 ICs.
THEY ALSO SERVE AS THE MAIN
CONTACT WITH THE DEPARTMENT OF
HEALTH AND HUMAN SERVICES, THE
OFFICE OF MANAGEMENT AND BUDGET,
AND CONGRESSIONAL APPROPRIATE
RANGE OF MOTION STAFF.
APPROPRIATION
STAFF.
HERE AT OUR INSTITUTE, WE HAVE
THE FINANCIAL MANAGEMENT BRANCH.
EVERY IC HAS THEIR OWN BUDGET
OFFICE.
OUR ROLE IS TO PROVIDE ADVICE
AND GUIDANCE TO LEADERSHIP AND
STAFF TO DEVELOP SPENDING PLANS
TO SUPPORT THE IC PRIORITIES.
TO PROVIDE INFORMATION TO GUIDE
PLANNING FOR FUTURE YEARS, AND
THEN TO MONITOR THE SPENDING
THAT WE DO IN THE FISCAL YEAR
FOR ADHERENCE TO THE PLAN WE'VE
LAID OUT AND TO THE FEDERAL
RULES THAT WE HAVE TO FOLLOW.
SO ONCE WE GET AN APPROPRIATION,
WE CREATE WHAT WE CALL AN
OPERATING PLAN AND THAT IS
REALLY THE PLAN FOR OUR YEAR, AS
WE FINISH OUT THE YEAR, WE WILL
RECONCILE WHAT ACTUALLY HAPPENED
COMPARED TO THE PLAN.
BUT THE PLAN IS VERY IMPORTANT
BECAUSE WE ARE PROHIBITED FROM
OVERSPENDING WHAT IS
APPROPRIATED TO US FROM
CONGRESS, AND WE DO TRY TO SPEND
AS MUCH AS POSSIBLE AND GET AS
CLOSE AS WE CAN BECAUSE ANY
UNSPENT FUNDS USUALLY ARE NOT
AVAILABLE TO US ONCE WE GET INTO
THE NEXT FISCAL YEAR.
SO THE PLAN FOR THE YEAR IS
DISPLAYED IN DETAIL ON WHAT WE
CALL A MECHANISM TABLE.
THE MECHANISM TABLE SHOWS HOW
THE IC WILL USE THE BUDGET THAT
WE'RE GIVEN.
GRANTS, CONTRACTS, INTRAMURAL
RESEARCH, OTHER ADMINISTRATIVE
COSTS.
IT'S DEVELOPED INITIALLY AS PART
OF THE PRESIDENT'S BUDGET AND
THEN WE REVISE TO REFLECT
CHANGES IN THE ACTUAL
APPROPRIATION OR THE OPERATING
PLAN.
WE UPDATE IT THROUGHOUT THE YEAR
AND THEN AS I SAID, WE RECONCILE
OUR FINAL SPENDING, ALSO IN A
MECHANISM FORMAT.
THE MECHANISM TABLE ALLOWS
COMPARISONS SORT OF ACROSS NIH
BECAUSE THE INSTITUTES REALLY
ARE DIFFERENT IN THE WAY THAT
THEY SUPPORT SCIENCE.
SO THIS IS A MECHANISM TABLE
THAT SHOWS OUR ACTUAL SPENDING
FROM FISCAL YEAR 23 AND 24.
YOU CAN SEE THAT IT IS SORT OF
SEGMENTED OUT INTO TYPES OF
GRANTS AT THE TOP.
RESEARCH PROJECT GRANTS, SMALL
BUSINESS, OUR CENTERS, YOU CAN
SEE RESEARCH CAREERS OR K
GRANTS.
WE HAVE OUR TRAINING GRANTS, R &
D CONTRACTS, INTRAMURAL RESEARCH
AND THEN AT THE BOTTOM, WE HAVE
RESEARCH MANAGEMENT AND SUPPORT
WHICH IS REALLY THE
ADMINISTRATIVE COSTS FOR
EVERYONE WHO DOESN'T WORK IN
INTRAMURAL RESEARCH.
YOU CAN SEE THAT WE DID HAVE A
SMALL BUDGET INCREASE OF ABOUT
$10 MILLION FROM FY 23 INTO FY
24.
IS THAT MONEY WAS REALLY TARTED
AT OUR IMPROVE PROGRAM
SPECIFICALLY BY CONGRESS.
WE DO TRY TO INCREASE OUR
TRAINING SPENDING.
WHEN WE HAVE INCREASES IN
APPROPRIATION, YOU CAN ALSO TELL
WE HAD A SIGNIFICANT AMOUNT OF
HIRING IN FY 24 WHICH INCREASED
OUR ADMINISTRATIVE SPENDING.
THIS IS JUST A PIE CHART SHOWING
THE FY 24 INFORMATION.
CAN YOU SEE WE SPEND 55% OF OUR
BUDGET ON RESEARCH PROJECT
GRANTS, ABOUT 5% ON THOSE
ADMINISTRATIVE COSTS, 13% ON
INTRAMURAL RESEARCH, AND THEN
THOSE OTHER GRANT CATEGORIES AND
THE R & D CONTRACTS ARE ALL LESS
THAN 10%.
SO WHEN WE'RE LOOKING AT
BUILDING A BUDGET, THERE'S ALSO
OTHER THINGS WE HAVE TO
CONSIDER.
ONE OF THOSE IMPORTANT THINGS IS
OUR MANDATED PROGRAM.
SO WITHIN OUR APPROPRIATION,
NICHD IS AN INSTITUTE THAT
PARTICIPATES IN AIDS FUNDING.
SO LAST YEAR, IN 24, WE WERE
REQUIRED TO SPEND ABOUT
$153 MILLION OF OUR
APPROPRIATION ON AIDS RESEARCH,
AND ALL OF THAT FUNDING BY THE
NIH OFFICE OF AIDS RESEARCH AND
ALL OF THE GRANTS AND PROJECTS
FUNDED MUST SORT OF HIT NIH AIDS
PRIORITY RESEARCH AREAS.
WE ALSO ARE REQUIRED TO SPEND A
PORTION OF OUR APPROPRIATION ON
SMALL BUSINESS INNOVATION
RESEARCH AND SMALL BUSINESS
TECHNOLOGY TRANSFER PROGRAMS.
WE USUALLY ABBREVIATE THAT TO
SBIR AND STTR.
LAST YEAR THAT WAS ABOUT
$52 MILLION.
AND THOSE ARE REQUIREMENTS AND
WE TRACK THOSE ACROSS ALL OF OUR
AREAS FOR THE FISCAL YEAR.
WE ALSO THEN ARE ALSO LOOKING AT
OUR NON-GRANT MECHANISMS EVERY
YEAR.
PERSONNEL COSTS, PAY RAISES FOR
STAFF, HIRING, PRINCIPAL
INVESTIGATORS WHO ARE BEING
RECRUITED INTO THE INTRAMURAL
PROGRAM.
WE HAVE MANDATED INCREASES IN
WHAT WE CALL OUR NIH ASSESSMENT,
SO THOSE ARE TRANS-NIH COSTS
THAT EVERY INSTITUTE HELPS TO
PAY FOR.
THINGS LIKE CYBERSECURITY, THE
CLINICAL CENTER, ANY RENOVATIONS
TO OUR LAB SPACE OR
ADMINISTRATIVE BUILDINGS, AND
OUR IC SERVICES THAT ARE
PROVIDED BY OUR ICs SUCH AS
INFORMATION TECHNOLOGY AND
COMMUNICATIONS.
WE ALSO ARE ALWAYS TRYING TO
PLAN FOR THE UNEXPECTED.
AS DR. BIANCHI ALLUDED TO.
SO RESCISSIONS ARE WHEN THE
CONGRESS MAKES REDUCTIONS TO OUR
BUDGET.
THAT CAN HAPPEN, AND YOU NEVER
KNOW WHAT THEY'RE GOING TO DO
HONESTLY.
WE HAVE OTHER TYPES OF
ASSESSMENTS OUTSIDE NIH
INCLUDING FOR THE DEPARTMENT OF
HEALTH AND HUMAN SERVICES.
THERE CAN BE UNEXPECTED NEEDS
AND EMERGENCIES SUCH AS COVID-19
OR ZIKA, FOR EXAMPLE.
AND WE DO HAVE TO FIGURE OUT HOW
TO ACCOMMODATE NEW NIH POLICIES
THAT WE DON'T CONTROL GENERALLY
THAT INCREASE PERCENTAGE FOR
TRAINING STIPENDS, SO WE'RE
ALWAYS TRYING TO PREDICT WHAT
THAT DECISION WILL BE.
AND THEN WE ALSO NEED TO ADAPT
FOR NEW LEGISLATIVE OR POLICY
MANDATES SUCH AS OUR IMPROV
PROGRAM AND WE USUALLY HAVE SOME
AMOUNT OF SAVINGS EVERY YEAR AND
SO WE'RE ALWAYS TRYING TO
PROJECT HOW MUCH THAT WILL BE IN
A GIVEN FISCAL YEAR.
THIS IS JUST A SNAPSHOT FOR
FOLKS OF OUR INTRAMURAL AND OUR
RMS BUDGETS JUST TO SHOW YOU HOW
MUCH WE ARE SPENDING ON
STAFFING, AS WELL AS OUR
ASSESSMENTS.
AND THEN THE OTHER CATEGORY,
WHICH INCLUDES THINGS LIKE
SUPPLIES, EQUIPMENT, TRAVEL,
TRAINING, ET CETERA.
AS YOU CAN SEE IN THE INTRAMURAL
RESEARCH SIDE OF THE PIE, THOSE
KINDS OF OTHER COSTS ARE A LOT
HIGHER THAN ON THE RESEARCH
MANAGEMENT AND SUPPORT SIDE,
WHERE SALARIES ARE REALLY OUR
BIGGEST COST.
SO I'M GOING TO SHIFT NOW INTO
OUR GRANT BUDGETS, WHICH IS
USUALLY WHAT FOLKS ARE MOST
INTERESTED IN.
SO WHEN WE'RE LOOKING AT
DEVELOPING A BUDGET FOR OUR
GRANTS, WE REALLY HAVE A LOT OF
FACTORS TO TAKE INTO
CONSIDERATION.
AS YOU MAY HAVE SPOTTED ON OUR
MECHANISM SLIDE, WE HAVE OVER
$700 MILLION IN NONCOMPETING
COMMITMENTS AT THE START OF THE
FISCAL YEAR RIGHT NOW.
SO THAT'S A BIG CHUNK OF WHAT
WE'RE PROJECTING WILL NEED TO BE
PAID THIS YEAR.
WE'RE ALSO LOOKING AT OUR RFA
COMMITMENTS THAT WE'VE ALREADY
ANNOUNCED, AND COFUNDING
COMMITMENTS FOR TRANS-NIH
INITIATIVES SUCH AS THE
BLUEPRINT FOR NEUROSCIENCE, THE
BRAIN INITIATIVE, OR CENTERS FOR
AIDS RESEARCH.
WE DO ALSO TRY TO SET ASIDE
FUNDS AND TARGET ESIs, EARLY
STAGE INVESTIGATORS, AND THEN
WHEN YOU TAKE INTO ACCOUNT THAT
WE'RE SPENDING MORE THAN
$300 MILLION ON INTRAMURAL AND
OTHER ADMINISTRATIVE EXPENSES,
WE REALLY HAVE ROUGHLY
$200 MILLION OR LESS EACH YEAR
FOR NEW INVESTIGATOR INITIATED
APPLICATIONS.
WE'RE ALSO VERY COGNIZANT OF
SUPPORTING FUNDING COMMITMENTS
WE'VE MADE, SO OUR NATIONAL
CENTER FOR MEDICAL
REHABILITATION RESEARCH IS
GENERALLY PROVIDED 6 1/2% OF OUR
EXTRAMURAL FUNDING FOR THEIR
SCIENCE.
WE ALSO LOOK AT OUR TRAINING
MECHANISMS, THE T, F AND K
GRANTS FOR THOSE FAMILIAR WITH
ACTIVITY CODES, AND WE TRY TO
TARGET ABOUT 6% OF OUR
EXTRAMURAL FUNDING TO THOSE
AREAS AS WELL.
SO PUTTING ALL OF THIS TOGETHER,
OUR NIH LEADERSHIP IS PROVIDING
GUIDANCE ON OVERALL LEVELS LEVER
THINGS YOU'LL SEE HERE ON THE
LEFT-HAND SIDE.
SO SUPPLEMENTS, BOTH DIVERSITY
SUPPLEMENTS, AND REGULAR
ADMINISTRATIVE SUPPLEMENTS,
WHETHER OR NOT WE SHOULD HAVE
ANY REDUCTIONS TO OUR
R01 APPLICATIONS, OUR RFAs OR
OUR NONCOMPETING GRANTS.
THEY HELP PROVIDE GUIDANCE ON
COLLABORATIONS WE'RE DOING, BOTH
FUNDS COMING IN TO THE IC AND
FUNDS LEAVING THE IC.
AND WE ALSO, EVERY YEAR, HAVE A
SMALL AMOUNT OF MONEY WE SET
ASIDE FOR WHAT WE CALL OUR
DIRECTOR'S RESERVES TO HELP US
ADDRESS PRIORITY AREAS THAT WE
MAY NOT HAVE KNOWN ABOUT AT THE
START OF THE FISCAL YEAR.
SO AS I SAID, WE LOOK AT OUR --
ALSO LOOK AT OUR NONCOMPETING
COMMITMENTS.
THERE ARE ON OCCASION SOME
THINGS WHICH CANNOT BE PAID THAT
FACTORS INTO OUR SAVINGS, AND WE
SET ASIDE FUND FOR SOME OF OUR
TAPS AND ASSESSMENTS AND MAKE
SURE WE'RE MEETING OUR
CONGRESSIONALLY MANDATED
PROGRAMS SUCH AS AIDS AND
IMPROVE.
WE LOOK AT THESE EVERY YEAR.
AND CONSTANTLY RE-EVALUATING.
WHEN IT COMES TO FIGURING OUT
HOW MUCH WE HAVE FOR
INVESTIGATOR INITIATED PROJECTS,
WE ARE LOOKING AT ALL OF THE
FUNDS WE HAVE FOR THE YEAR AFTER
ALL OF OUR SETASIDES, ALL OF OUR
OTHER COSTS ARE PAID, AND WE
REALLY LOOK AT THE HISTORICAL
FUNDING AND LOOK AT A THREE-YEAR
AVERAGE TO TRY TO FIGURE OUT
ROUGHLY WHAT PERCENTAGE OF OUR
MONEY IS SPENT IN EACH COUNCIL
ROUND, AND THEN DIVIDE THE FUNDS
AVAILABLE FOR THE YEAR USING
THAT SPENDING PATTERN.
AND WE REVIEW APPLICATIONS AT
DIFFERENT SCORE BREAKS TO TRY TO
ASSESS COST AND FIGURE OUT AN
ALLOCATION WHICH CAN BE
CONSISTENT ACROSS THE COUNCIL
ROUNDS.
WE REALLY TRY IN THE BUDGET
OFFICE NOT TO DISADVANTAGE AN
INVESTIGATOR SIMPLY BECAUSE OF
WHICH RECEIPT DATE THEY SENT
THEIR APPLICATION IN.
YOU KNOW, WE DON'T WANT TO
PROVIDE SO MUCH FUNDING TO
OCTOBER COUNCIL FOR EXAMPLE,
THEN WHEN WE GET TO JUNE, WE
CAN'T HAVE SORT OF AN EVEN AWARD
STRUCTURE BASED -- FOR FOLKS WHO
GOT THE SAME SCORE.
YOU CAN SEE HERE THIS IS THE
PERCENTAGES FOR FY 22, 23 AND
24.
THERE IS VARIANCE YEAR TO YEAR
AND THAT'S WHY WE USUALLY RELY
ON A THREE-YEAR AVERAGE.
THIS IS FOR FOLKS TO SEE,
ESPECIALLY SOME OF OUR NEWER
FOLKS.
THIS IS OUR SUCCESS RATES FOR
OUR R01s FROM 2019 TO 2024.
THE 2024 NUMBERS ARE NOT YET
OFFICIAL.
THESE ARE JUST ESTIMATES AT THIS
POINT.
HOPEFULLY THEY'RE PRETTY CLOSE
TO WHAT WILL BE FINAL.
BUT YOU CAN SEE WE HAVE DONE A
PRETTY GOOD JOB IN THE RECENT
YEARS AT TRYING TO SORT OF KEEP
THAT SUCCESS RATE UP AND TO KEEP
IT RELATIVELY CONSTANT.
THE NEXT SLIDE, I ALSO HAVE
INFORMATION ON OUR EARLY STAGE
INVESTIGATORS, OR THE ESIs.
WE DO AS I MENTIONED SET ASIDE
ADDITIONAL FUNDS TO TRY TO FUND
MORE ESIs IF POSSIBLE, AND
THEN THIS IS OUR SUCCESS RATE
OVER THE LAST SEVERAL YEARS FOR
ESIs.
AGAIN WITH 2024 AS JUST AN
ESTIMATE.
AND NOT YET OFFICIAL.
WHEN WE LOOK AT OTHER MECHANISMS
ASIDE FROM RPGs, THERE MAY BE
A FEW DIFFERENT BUDGET
CONSIDERATIONS.
REDUCING THE AMOUNT FOR A NEW
GRANT MAY NOT BE FEASIBLE AS IT
MIGHT BE FOR AN R01.
WE ALSO LOOK AT OFFSETS THAT MAY
BE AVAILABLE WHICH OFFSETS LOOK
AT LARGE UNOBLIGATED BALANCES IN
RECOMPETING GRANTS, PARTICULARLY
K12s, T32s.
FOR TREA.FOR TRAINING MECHANISMR
F GRANTS WE TAKE INTO
CONSIDERATION THE
RECOMMENDATIONS OF THE NICHD
TRAINING COMMITTEE.
WE'RE LOOKING AT NIH WIDE
STIPEND INCREASE, MAKING SURE WE
SET ASIDE FUNDS FOR CHILD CARE
ASSISTANCE PAYMENTS THAT GO OUT
TO THOSE TRAINING GRANTEES.
WE DO SOLICIT INPUT FROM PROGRAM
STAFF WHEN WE HAVE A MECHANISM
THAT'S BEING USED THAT'S NOT
SOMETHING WE SEE ALL THE TIME TO
TRY TO GET INSIGHT INTO THOSE
AWARDS.
AND THEN HONESTLY, YOU KNOW IT'S
REALLY ABOUT AVAILABILITY OF
FUNDS.
AFTER WE'VE PAID ALL OF OUR
NONCOMPETING COMMITMENTS, HOW
MUCH MONEY IS REALLY LEFT OVER
FOR THOSE NEW AWARDS IN A GIVEN
YEAR.
THEN THE LAST THING I WAS GOING
TO SHOW YOU AT DR. BIANCHI
REFERENCED IT EARLIER, WE DO
SUPPORT FOR TRAINING SORT OF
PURPOSES OUR NIH EXTERNAL LOAN
REPAYMENT PROGRAMS.
THIS CHART SHOWS THE FUNDING
SINCE 2019.
WE DID HAVE A BIG INCREASE IN
2024.
THESE FUNDS GO OUT DIRECTLY TO
APPLICANTS WHO COMMIT TO
PURSUING RESEARCH.
THERE ARE SIX DIFFERENT LOAN
REPAYMENT PROGRAMS FOR THE
EXTRAMURAL COMMUNITY.
WE HAVE EXPANDED OUR
PARTICIPATION AND FUNDING AS YOU
CAN SEE OVER RECENT YEARS.
EVERY YEAR'S CONTRIBUTION IS
SORT OF SUBJECT TO OUR
APPROPRIATION.
SO WE'RE LOOKING TO SEE WHAT
CONGRESS DOES THIS YEAR, WHICH
WILL HELP US MAKE DECISIONS ON
HOW MUCH WILL GO INTO THIS
PROGRAM FOR 2025.
THAT'S THE END OF MY SLIDES.
I'M HAPPY TO 50 BACK TO A SLIDE
IF SOMEONE WANTS TO ASK A
QUESTION OR ASK ANY OTHER
QUESTIONS.
DR. MANDL.
>> GREAT AND INFORMATIVE
PRESENTATION.
I WONDER IF YOU CAN COMMENT,
EVEN IF NOT WITH THE EXACT
NUMBERS RIGHT NOW, ON THE
SUCCESS RATE THAT INCLUDES THE
REVISED APPLICATION.
IN OTHER WORDS, THE SUCCESS RATE
OVER A SUBMISSION AND A REVISION
OR WHETHER THOSE -- BECAUSE I
WAS ASSUMING THE SUCCESS RATES
IN YOUR TABLE FOR R01s WAS ON
THE FIRST SUBMISSION BUT I MIGHT
BE WRONG.
>> NO, SO THIS SUCCESS RATE
SHOULD BE FOR 01 OR
A1 APPLICATIONS COMBINED, SO
THIS WOULD BE EVERYBODY
TOGETHER.
I DON'T KNOW THE FIGURES FOR
THOSE THINGS SEPARATED OUT OFF
THE TOP OF MY HEAD, BUT I DO
BELIEVE -- WE TOOK THIS DATA
FROM THE NIH REPORTER, AND I
THINK THAT INFORMATION CAN BE
GOTTEN THERE, AND IF YOU'RE
INTERESTED, WE CAN LOOK AT THAT
AND SHARE THAT TOO.
>> OKAY, THAT'S VERY HELPFUL TO
KNOW THAT THIS IS INCLUDED IN
THE A1.
THANK YOU.
>> AND DR. CEDARS.
>> YES, THANK YOU SO MUCH.
THIS WAS REALLY INFORMATIVE AND
MY QUESTION IS ABOUT THE SAME
TOPIC, WHEN YOU SAY SUCCESS
RATE, I'M JUST TRYING TO THINK
ABOUT BEING ON A STUDY SECTION
AND PERCENTILE SCORES AND
PRIORITY SCORES AND KNOWING THAT
THE FUNDING LEVEL IN NICHD HAS
TRADITIONALLY BEEN QUITE LOW
COMPARED TO SOME OF THE OTHER
INSTITUTES.
THE 17.8%, CAN YOU -- HOW WOULD
THAT CORRELATE TO SOME OF THESE
OTHER METRICS?
>> IT'S A LITTLE DIFFICULT.
SO THE DENOMINATOR THAT
APPLICATIONS REVIEWED, I MEAN,
THAT REALLY IS EVERYTHING THAT
GOT REVIEWED.
WE DON'T, AS AN INSTITUTE,
CONTROL THAT.
ALL THE APPLICATIONS THAT CAME
IN, REGARDLESS OF STUDY SECTION
THAT GOT REVIEWED.
AND THEN IT REALLY IS JUST HOW
MANY OF THEM GOT PAID.
I WILL SAY THIS FIGURE INCLUDES
GRANTS THAT CAME IN UNDER
RFAs, AS WELL AS INVESTIGATOR
INITIATED APPLICATIONS.
SO THIS IS ALL R01 GRANTS.
SOLICITED OR NOT.
I MEAN, THAT'S THE WAY THE
SYSTEM DISTINGUISHES THEM,
RIGHT?
RFA IS SOLICITED, INVESTIGATOR
INITIATED IS UNSOLICITED.
SO WE DO OFTEN HAVE HIGHER
SUCCESS RATES FOR RFAs, FOR
EXAMPLE.
WE'VE SET ASIDE MONEYS FOR THOSE
AREAS OF SCIENCE.
KE WITH PWE CAN PICK UP AN APPLN
WITH A HIGHER SCORE.
THE ESIs ARE ALSO INCLUDED IN
THIS CHART HERE.
SO IF THERE'S ESIs, THESE
R01 APPLICATIONS, THAT IS ALSO
INCLUDED HERE.
SO I THINK A LOT OF TIMES SOME
OF THE CHALLENGE IS TEASING OUT
THE SUCCESS RATE FOR PURELY
UNSOLICITED THINGS.
FOR EXAMPLE, MAY NOT BE AS HIGH
AS FOR AN RFA RESPONSE OR
NON-ESI INVESTIGATORS.
AND THAT IS A CHALLENGE.
BUT I WILL TELL YOU, I CAME TO
NICHD IN 2010, AND WHEN I
STARTED HERE, THERE WERE YEARS
WHEN I WAS HERE AT THE BEGINNING
WHERE THE SUCCESS RATE WAS MORE
LIKE 11 OR 12% FOR R01s, SO WE
HAVE MADE SUBSTANTIAL
IMPROVEMENTS IN WHAT WE'VE BEEN
ABLE TO SUPPORT.
>> THANK YOU, THAT WAS HELPFUL.
>> SURE.
AND DR. AIZER?
>> THANK YOU.
I HAVE TWO QUESTIONS.
THE FIRST ONE, COULD YOU TALK A
LITTLE BIT MORE ABOUT THE
COFUNDING COMMITMENTS?
WHAT IS THAT EXACTLY?
>> SURE.
SO IT'S REALLY ABOUT
COLLABORATIONS BETWEEN
INSTITUTES.
SO IF -- LET ME THINK OF AN
EXAMPLE.
IF WE HAVE A PROGRAM, IN FACT I
THINK THERE'S AN ACTION PROBABLY
TOMORROW ON THE WELLSTONE CEN
CENTERS OF MUSCULAR DYSTROPHY, I
THINK.
THAT IS A COLLABORATION BETWEEN
THREE DIFFERENT INSTITUTES.
SO SOMETIMES WE ARE THE LEAD,
SOMETIMES WE ARE NOT THE LEAD.
WE MAY COMMIT TO THE OTHER
INSTITUTE.
WE'RE GOING TO GIVE YOU $500,000
FOR THIS RFA.
FOR GRANTS ON THIS TOPIC.
BECAUSE IT IS A PRIORITY FOR OUR
INSTITUTE BUT WE'RE NOT THE
LEAD.
SO THAT WOULD BE WHAT WE WOULD
CALL OUTGOING COFUNDING.
ON THE SAME TOKEN, ANOTHER IC
MAY SEE SCIENCE WE'RE DOING FOR
EXAMPLE THE OFFICE OF RESEARCH
FOR WOMEN'S HEALTH IN THE NIHOD
WILL PROVIDE COFUNDING TO US FOR
SOME OF OUR RESEARCH IN
GYNECOLOGICAL HEALTH BECAUSE
THAT'S A PRIORITY FOR THEM AND
THEY WANT TO BE ABLE TO SUPPORT
THAT.
THAT ESSENTIALLY GIVES US
RESOURCES ON TOP OF OUR OWN
APPROPRIATION WHEN THAT HAPPENS,
AND THAT'S INCOMING COFUNDING.
>> IS THAT GENERALLY
BUDGET-NEUTRAL?
>> IT IS -- HOW DO I PUT THIS?
SO OFFICE OF RESEARCH ON WOMEN'S
HEALTH HAS ITS OWN
APPROPRIATION, AND WE HAVE OURS.
WE CAN'T OVERSPEND, EITHER ONE
OF US.
SO WITHIN OUR BUDGETS, WE'RE
SPENDING WHAT WE HAVE.
>> I SEE.
>> BUT OFFICE OF RESEARCH ON
WOMEN'S HEALTH IS THEN HELPING
US TO MAYBE FUND MORE RESEARCH
ON WOMEN'S HEALTH BECAUSE THEY
ARE GIVING US SOME OF THEIR
MONEY.
>> GOT IT.
OKAY.
I JUST HAVE ANOTHER QUESTION
WHICH IS MORE OF A THINK
QUESTION IS, ARE THERE EFFORTS
OR SHOULD THERE BE EFFORTS TO
SORT OF LINK BUDGET PR PRIORITIS
WITH SOME METRIC OF SUCCESS?
>> I GUESS MY QUESTION IS, WHAT
KIND OF METRICS OF SUCCESS ARE
YOU THINKING OF?
>> I'D HAVE TO THINK ABOUT IT.
SOME MEASURES OF THE QUALITY AND
IMPORTANCE OF THE RESEARCH
OUTPUT.
>> YEAH.
I THINK THAT'S SOMETHING THAT
CERTAINLY GET DISCUSSED.
WE IN THE BUDGET OFFICE, WE
PROVIDE ALLOCATIONS TO THE
SCIENTIFIC BRANCHES FOR THEIR
BRANCH PORTFOLIOS.
AND THEY THEN MAKE THE DECISION
ABOUT HOW TO USE THAT MONEY.
AND SOMETIMES, YOU KNOW, THEY
MAY PICK SOMETHING THAT MAY NOT
HAVE, YOU KNOW, A THIRD
PERCENTILE SCORE BUT HAS REALLY
GOOD POTENTIAL FOR SOMETHING NEW
AND INNOVATIVE.
AND WE GIVE THEM THAT
FLEXIBILITY.
AND WE TRUST THAT THEY WILL LOOK
AT PRODUCTIVITY, LOOK -- AS THE
REVIEWERS HAVE ALREADY DONE TOO,
YOU KNOW, LOOK AT DEVELOPING
AREAS OF SCIENCE, THINGS LIKE
THAT.
AND TRY TO MAKE THOSE DECISIONS
WITH THE MONEY THAT WE PROVIDE
TO THEM.
I KNOW THEY WISH WE -- THEY
ALWAYS WISH WE COULD GIVE THEM
MORE.
MORE IS ALWAYS BETTER.
SO THERE ARE OFTEN A LOT OF
TRADEOFFS AND I THINK PROGRAM
STAFF IS REALLY LOOKING AT THOSE
KINDS OF THINGS WITHIN THEIR
FIELDS WHEN THEY ARE MAKING
DECISIONS ABOUT WHAT TO FUND.
>> I JUST WONDERED IF IT
WOULDN'T BE USEFUL TO DO
SOMETHING MORE RETROSPECTIVELY.
>> SO I THINK OUR OFFICE OF
SCIENCE POLICY RESEARCH, THEY DO
A LOT OF EVALUATION OF WHERE OUR
MONEY GOES AND SORT OF WHAT
COMES OUT OF IT, RIGHT?
ARE THERE CLINICAL PROTOCOLS
THAT ARE DEVELOPED THAT BECOME
ADOPTED WIDELY, PUBLICATIONS ARE
ALWAYS SOMETHING THAT PEOPLE --
I'M NOT A SCIENTIST BUT I HEAR A
LOT OF ARGUMENTS ABOUT HOW MUCH
WE SHOULD RELY ON PUBLICATION,
YOU KNOW, AS A METRIC, SO THERE
ARE OTHER PARTS OF THE INSTITUTE
THAT ARE LOOKING AT THOSE KINDS
OF THINGS.
WE DO TRY TO DISCUSS HOW FUNDING
SHOULD OR SHOULD NOT FOLLOW.
I MEAN, SOMETIMES YOU WANT TO
FUND THE THING THAT MAY OR MAY
NOT, YOU KNOW -- IT MAY NOT WORK
BUT YOU TRIED IT.
>> ROHAN, DIRECTOR OF DER.
I THINK ONE CONCRETE EXAMPLE IS
EVIDENCE FROM THE LOAN REPAYMENT
ANALYSIS THAT LOAN REPAYMENT
RECIPIENTS WERE MUCH MORE
SUCCESSFUL AT SUBSEQUENT NIH --
RECEIVING SUBSEQUENT NIH FUNDING
AND THAT WENT INTO OUR DECISION
TO INCREASE THE LOAN REPAYMENT
PROGRAM.
SO WE HAVE DONE AT LEAST ON A
SMALL SCALE, ANNA, SOME OF THE
THINGS THAT YOU'RE TALKING
ABOUT.
>> OKAY, THAT'S GREAT TO HEAR.
IF THERE ARE REPORTS THAT ARE
BEING PRODUCED, I WOULD BE VERY
INTERESTED IN READING THEM.
THANK YOU.
>> THANK YOU.
DR. SESSIONS?
>> THANK YOU VERY MUCH.
THIS IS VERY INTERESTING.
I WONDER WHAT YOU PREDICT OR
HAVE ACCESS TO PREDICTING IN
TERMS OF THE TOTAL NUMBER OF
APPLICATIONS YOU REVIEWED PER
YEAR.
MY INTUITION WOULD BE
SPECULATION WITH NO DATA, I
NEVER LET THE DATA GET IN THE
WAY OF MY SPECULATION, THAT I
WOULD SPECULATE THAT THE IN
INSTITUTE WOULD LIKE TO SEE AN
INCREASING NUMBER OF
APPLICATIONS PER YEAR.
>> I THINK THAT'S A MIXED BAG,
DR. SESSIONS.
SO I'M GOING TO SAY OVERALL, ALL
OUR PG MECHANISMS, ACTIVITY
CODES ALL TOGETHER, OUR
INSTITUTE LAST YEAR HAD ABOUT
2700 APPLICATIONS THAT WERE
REVIEWED.
SO IT INCLUDES THINGS OUTSIDE OF
R01s, INCLUDES R3s, R21s,
ALL THE LITTLE ODD DUCKS AS
WELL.
I THINK WE WANT TO HAVE MORE
APPLICATIONS IF THEY ARE
APPLICATIONS THAT APPLY TO OUR
SCIENCE.
WE HAVE HAD INSTANCES IN THE
PAST WHERE THE REVIEW CRITERIA,
AND THERE'S STAFF HERE AT THE
INSTITUTE WHO WORK VERY HARD ON
THE CRITERIA FOR NIH TO DECIDE
WHICH INSTITUTE GETS AN
APPLICATION.
RIGHT?
AND SO I THINK WE WOULD LIKE TO
SEE INCREASED APPLICATIONS IF
THERE REALLY ARE PRIORITY
SCIENCE.
WE DON'T WANT TO SEE AN INCREASE
IN APPLICATIONS WHEN THEY'RE
APPLICATIONS THAT SHOULD MAYBE
GO TO A DIFFERENT IC, BECAUSE
IT'S THAT IC'S PRIORITY AND NOT
OURS.
DR. BIANCHI, DID YOU WANT TO --
>> IF I COULD COMMENT ON THAT,
SESH.
THAT'S ONE OF THE BENEFITS OF
HAVING A STRATEGIC PLAN.
I WOULD SAY THAT EIGHT YEARS
AGO, IF IT HAD THE WORD
"CHILDREN" OR "CHILD" OR
PEDIATRICS, OFTENTIMES IT WENT
FIRST TO NICHD AND IT DIDN'T
NECESSARILY ALIGN WITH AREAS OF
OUR INTEREST.
SO HAVING A STRATEGIC PLAN HAS
ALLOWED US TO ALIGN THE SCIENCE
WITH THE FUNDED APPLICATIONS.
AND WE CONTINUOUSLY TALK ABOUT
THIS, ALTHOUGH I THINK IT'S
GOTTEN BETTER WHAT CENTER FOR
SCIENTIFIC REVIEW SENDS US, I
THINK THEY HAVE A BETTER
UNDERSTANDING NOW OF WHAT OUR
PRIORITIES ARE, AND WHERE WE'RE
LIKELY TO ACCEPT SOMETHING FOR
REVIEW.
BUT I WOULD SAY EIGHT YEARS AGO,
THE APPLICATIONS THAT WE
RECEIVED WERE PRETTY UNFOCUSED
AND DIDN'T ALLOW US TO GO DEEP
IN ANY SPECIFIC AREA.
>> RIGHT.
THANK YOU VERY MUCH.
I -- AS AN EXAMPLE, I MIGHT
PREDICT THAT THE STRATEGIC
PLAN'S INCLUSION OF ARTIFICIAL
INTELLIGENCE MIGHT EXPAND THE
NUMBER OF APPLICATIONS IN TERMS
OF HOW WE STUDY DEVELOPMENT.
BECAUSE OF THE EXPANDING
UNDERSTANDING OF APPLICATION OF
ALREADY AVAILABLE DATA TO NEW
TECHNIQUES, WITH NEW TECHNIQUES.
AND I WOULD HOPE THAT WE WOULD
GET SOME OF THOSE, WHICH WOULD
BE DIFFERENT FROM THE ONES THAT
WE HAVE HISTORICALLY SORT OF
REVIEWED.
>> DR. JABS?
>> I THINK I HAVE TWO QUESTIONS.
MY FIRST QUESTION IS WE'VE HAD A
PRESENTATION OF THE INSTITUTE
ACE PRIORITY, AND WE'VE HAD A
PRESENTATION OF THE BUDGET.
I'M JUST WONDERING WITH
CHANGE -- THE POLITICAL CHANGE
THAT WILL HAPPEN THIS MONTH, HOW
MUCH OF THAT CAN CHANGE?
>> WELL, IT CAN CHANGE -- IF WE
GET DIRECTIVES FROM CONGRESS OR
WE GET DIRECTIVES FROM THE
PRESIDENT ABOUT AREAS OF SCIENCE
THAT THEY WISH US TO INVEST IN.
YOU KNOW, WE WORK ON THAT, HOW
DO WE PRIORITIZE THAT, WHAT'S
THE CHANGES THAT ARE NECESSARY?
THE IMPROVE PROGRAM STARTED OUT
AS SOMETHING WHICH DID NOT HAVE
A DEDICATED STREAM OF FUNDING AT
NIH.
IT WAS SOMETHING THE ICs CAME
TOGETHER TO FUND BUT IT DIDN'T
HAVE A DEDICATED STREAM AND THE
CONGRESS DECIDED THAT THAT WAS
NOT ENOUGH.
THEY WANTED A DEDICATED FUNDING
POT, FOR EXAMPLE.
SO THEY TOLD US HOW MUCH MONEY
WE SHOULD BE PUTTING INTO IT.
SO THAT IS ONE OF THOSE THINGS
WE HAVE TO THEN CONSIDER, HOW DO
WE SHIFT AND BALANCE.
I THINK THAT'S WHAT THE
LEADERSHIP DECISIONS OFTEN COME
DOWN TO, IS HOW DO WE SHIFT
PRIORITIES, HOW DO WE FOCUS
RESOURCES.
IF WE HAVE REDUCTIONS IN BUDGET
BUT INCREASED COST, WE HAVE TO
MAKE SOME TRADEOFFS.
>> I WOULD JUST SAY THAT EACH
ADMINISTRATION HAS THEIR
PRIORITIES AND THERE'S A LONG
TRACK RECORD AT NIH OF WORKING
WITH EACH ADMINISTRATION TO FIND
COMMON GROUND.
AND THAT'S WHAT WE WILL DO.
WE DON'T KNOW ANYTHING YET.
THE TRANSITION HASN'T OCCURRED.
SO ONCE IT OCCURS, WE LOOK
FORWARD TO WORKING WITH THE NEW
FOLKS WHO WILL BE IN CHARGE.
>> I GUESS MY OTHER QUESTION IS
SOME AREAS OF RESEARCH REQUIRE A
HIGHER BUDGET THAN OTHERS.
FOR EXAMPLE, A LOT OF THE OMICS
RESEARCH WITH HIGH COSTS OF
SEQUENCING AND THINGS, ALTHOUGH
THOSE COSTS ARE COMING DOWN WITH
TIME.
AND THEN ANOTHER AREA IS GENE
THERAPY, THE ACTUAL THERAPEUTIC
ITSELF COULD BE COSTLY TO
ADMINISTER, YOU KNOW.
AND SO THE QUESTION IS, HOW DO
YOU WEIGH PROJECTS THAT
INHERENTLY HAVE MORE COSTS TO
THEM THAN OTHERS THAT DO NOT.
FOR EXAMPLE, MY DROSOPHILA WORK
IS CHEAPER TO DO THAN MOUSE
WORK.
I'M JUST WONDERING HOW THAT'S
DONE.
>> SO I THINK WHAT WE TRY TO DO
IN BUDGET IS PROVIDE -- WE WORK
WITH OUR STAFF TO TRY TO PROVIDE
ALLOCATIONS OUT TO THE BRANCHES
THAT FOR EACH COUNCIL ROUND ARE
BASED ON THE APPLICATIONS THEY
HAVE IN HAND.
AND THEN THE BRANCHES THEN MAKE
DECISIONS ABOUT COULD YOU TRIM
AN APPLICATION OR NOT?
IF YOU TRIMMED IT, WOULD IT BE
DETRIMENTAL TO THE SCIENCE?
DO YOU HAVE TO LOOK AT -- YOU
HAVE TO LOOK AT THE AIMS AND
THINGS LIKE THAT.
SO BECAUSE WE'RE BASING OUR
ALLOCATIONS ON -- FOR EACH
COUNCIL ROUND ON THE
APPLICATIONS IN HAND, I THINK
OUR FUNDING IS TAKING INTO
ACCOUNT THE DIFFERENT COSTS OF
THAT DIFFERENT SCIENCE AS YOU
WERE OUTLINING.
IT MAY MEAN IF WE GET A LOT OF
CLINICAL TRIALS IN ONE ROUND,
HONESTLY, WE MAY NOT BE ABLE TO
FUND AS MANY GRANTS.
BUT YOU KNOW, WE'RE TRYING TO
BASE THE FUNDING WE GIVE TO OUR
BRANCHES ON WHAT THEY ACTUALLY
HAVE IN FRONT OF THEM FOR THAT
COUNCIL ROUND.
>> CAN I ASK ONE?
>> SURE.
>> MIMI, SOME OF THE BIG TICKET
ITEMS YOU WERE ALLUDING TO,
EITHER GENOMICS INITIATIVES OR
CLINICAL TRIALS OR BIG PROGRAMS,
THERE ARE FREQUENTLY NIH-WIDE
PROGRAMS.
SOME OF THEM WILL HAVE A
SEPARATE APPROPRIATION, SOME OF
THEM DO NOT.
SO THAT'S WHY WE HIGHLIGHTED THE
KIDS FIRST INITIATIVE THAT HAS A
SEPARATE INITIATIVE, AND IS
PAYING FOR A LOT OF GENOMIC
SEQUENCING FOR A LOT OF
RESEARCHERS WHO HAVE COHORTS OF
CHILDREN WITH EITHER CANCER OR
STRUCTURAL ANOMALIES.
IF IT SOMETHING THAT IS JUST
WITHIN OUR BUDGET, WE HAVE TO
MAKE DIFFICULT CHOICES.
THE PIE DOESN'T NECESSARILY GET
BIGGER, IN FACT, IT MIGHT GET
SMALLER NOW.
SO AGAIN, THE STRATEGIC PLAN IS
OUR STARTING POINT, AND IT KIND
OF WILL TELL YOU WHAT WE'RE NOT
GOING TO FUND, SO, THEREFORE,
THAT TYPE OF RESEARCH WILL HAVE
TO GO TO ANOTHER INSTITUTE OR
CENTER, AND AS ALWAYS, WE
ENCOURAGE PROSPECTIVE APPLICANTS
TO TALK TO PROJECT OFFICIALS OR
PROGRAM OFFICIALS TO INQUIRE
WHETHER THIS PARTICULAR AREA OF
RESEARCH IS OF INTEREST TO
NICHD.
>> DR. CEDARS?
>> THANK YOU.
THIS DISCUSSION AND DR. JABS'
QUESTIONS BROUGHT UP AN ISSUE
FOR ME KIND OF TYING TOGETHER
YOUR CONVERSATION AND
DR. BIANCHI'S PRESENTATION.
AND I JUST WANTED TO REVISIT THE
WOMEN'S HEALTH RESEARCH ISSUE
AND AGAIN, APPRECIATE NICHD'S
FOCUS ON THIS.
I DID LOOK QUICKLY AT THE
ARTICLE THAT WAS SENT, AND JUST
TO SO -- TWO SORT OF RELATED
QUESTIONS.
ONE IS EVEN IN THAT ARTICLE THEY
QUOTE ABOUT 10% OF NIH BUDGET
GOING TO WOMEN'S HEALTH
RESEARCH.
I THINK THE NASEM REPORT WAS
ABOUT 8%.
SO STILL IN THE SAME LEVEL AND
LOW, AND THERE WAS A LOT OF
DISCUSSION IN THE ARTICLE ABOUT
BIDEN'S -- THE WHITE HOUSE
INITIATIVE, AND I REALIZE YOU
HAVE NO CRYSTAL BALL, ALTHOUGH I
WISH WE ALL DID.
BUT GIVEN THE INCOMING CHANGE IN
THE WHITE HOUSE, WHAT'S GOING TO
HAPPEN TO THE WOMEN'S -- THE
WHITE HOUSE INITIATIVE FOR
WOMEN'S HEALTH RESEARCH, AND
AGAIN EVEN WITHIN NICHD, ARE
THERE CONSIDERATIONS FOR
INCREASING THE PERCENT OF FUNDS
THAT GO TO WOMEN'S HEALTH OVER
THIS ACROSS THE BOARD NIH
INCLUDING A REALLY HIGH AMOUNT
THAT GOES TO BREAST CANCER AND
OTHER ISSUES THAT'S INCLUDED IN
THAT WOMEN'S HEALTH RESEARCH?
ANY THOUGHT ABOUT HOW WE
INCREASE THE AMOUNT OF DOLLARS
THAT ACTUALLY GO TO WOMEN'S
HEALTH RESEARCH, PARTICULARLY IN
THE CURRENT POLITICAL
ENVIRONMENT?
THANK YOU.
>> I DREW THE SHORT STRAW TO
ANSWER YOU.
I MEAN, WE DON'T KNOW WHAT THE
NEW ADMINISTRATION IS THINKING
OR WILL BE THINKING.
WHAT I CAN TELL YOU IS THERE'S
BEEN AN ENORMOUS AMOUNT OF
EFFORT OVER THE PAST YEAR TO
INCREASE THE FOCUS ON WOMEN'S
HEALTH RESEARCH.
AND HOPEFULLY ONE OF THE
TAKEAWAYS OF THE NASEM REPORT
AND OF THE TREMENDOUS AMOUNT OF
WORK THAT'S BEEN DONE IN THE
PAST YEAR IS TO EDUCATE CONGRESS
ABOUT THE NEED FOR INCREASING
SUPPORT FOR WOMEN'S HEALTH
RESEARCH.
THAT BEING SAID, WE HAVE THE
ABILITY TO SHIFT PRIORITIES,
SHIFT PERCENTAGES AS YOU
MENTIONED AND WE SPECIFICALLY
MENTIONED THE ACT ENDO
INITIATIVE BECAUSE THAT, WE PUT
$3 MILLION ON THE TABLE
IMMEDIATELY AFTER OR AROUND THE
TIME THAT THE PRESIDENT -- THAT
PRESIDENT BIDEN MENTIONED IN THE
STATE OF THE UNION THAT HE
WANTED TO INCREASE SUPPORT FOR
WOMEN'S HEALTH RESEARCH.
SO WE CAN DO THINGS LIKE THAT,
YOU KNOW, IF IT COMES TO LARGE
ITEMS, THAT'S GOING TO BE
WHATEVER THE NEW ADMINISTRATION
LISTS AS A PRIORITY.
BUT YOU KNOW, THERE ARE
SIGNIFICANT NUMBER OF WOMEN IN
CONGRESS WHO ARE
REPRESENTATIVES, AND YOU KNOW,
PRESUMABLY THEY ARE AWARE OF
SOME OF THE ISSUES.
SOME OF THE THINGS LIKE, YOU
KNOW, MATERNAL MORTALITY, THOSE
ARE BIPARTISAN, BICAMERAL
ISSUES.
SO I THINK WE NEED TO FOCUS ON
THOSE.
THINGS THAT WE NEED TO WORK ON
TOGETHER TO SOLVE THE PROBLEMS.
BUT I DON'T HAVE A CRYSTAL BALL,
I DON'T KNOW WHAT THE NEW
PRIORITIES WILL BE, BUT ONCE WE
LEARN ABOUT THEM, WE WILL WORK
VERY HARD TO FIND COMMON GROUND
AND TO USE THE RESOURCES WE HAVE
TO ADDRESS THE PROBLEMS AND FIND
SOLUTIONS THROUGH RESEARCH.
>> THANK YOU.
>> ANY OTHER QUESTIONS OR
CONCERNS, COMMENTS?
ALL RIGHT.
WELL, THANK YOU VERY MUCH.
CERTAINLY IF YOU THINK OF ANY
QUESTIONS, I'M HAPPY TO ANSWER
THINGS IN THE FUTURE.
AND THANK YOU FOR YOUR TIME AND
ATTENTION.
>> THANK YOU, ALEXIS.
AGAIN, VERY, VERY IMPORTANT
PRESENTATION.
WE ALWAYS APPRECIATE YOUR
MASTERY AND MANAGEMENT OF THE
NIH BUDGET, AND YOU DO IT WITH
GOOD HUMOR TOO, WHICH IS
REQUIRED IN THIS POSITION.
SO AT THIS TIME, WE'RE GOING TO
TAKE A 10-MINUTE BREAK UNTIL --
WE'RE NOT TAKING A 10-MINUTE
BREAK?
20 MINUTES.
ISN'T IT 1:55?
NO, IT'S NOT.
SORRY.
WE EARNED ANOTHER 10 MINUTES.
SO WE WILL COME BACK AT 2:05 --
2:00.
BE ON AT 2:00.
WE'RE GOING TO HAVE A FANTASTIC
PRESENTATION FROM THE NEW --
RELATIVELY NEW DIRECTOR OF
NIAID, DR. MARRAZZO.
SO ENJOY YOUR BREAK.
>> WELCOME BACK, EVERYONE.
IT IS NOW MY GREAT PLEASURE TO
INTRODUCE OUR NEXT SPEAKER,
DR. JEANNE MARRAZZO.
DR. MARRAZZO WAS APPOINTED AS
DIRECTOR OF THE NATIONAL
INSTITUTE OF ALLERGY AND
INFECTIOUS DISEASES, OTHERWISE
KNOWN ACI AS NIAID IN THE FALL F
2023, WHERE SHE OVERSEES A
$6.6 BILLION BUDGET JUST FOR
FRAME OF REFERENCE, OUR BUDGET
IS $1.75 BILLION.
SHE'S ALSO A LEADING RESEARCHER
IN THE FIELD OF SEXUALLY
TRANSMITTED INFECTIONS,
ESPECIALLY AS THEY AFFECT
WOMEN'S HEALTH.
PRIOR TO HER POSITION AT NIAID,
SHE WAS DIRECTOR OF THE DIVISION
OF INFECTIOUS DISEASES AT THE
UNIVERSITY OF ALABAMA AT
BIRMINGHAM, AND SHE HAS CHAIRED
THE AMERICAN BOARD OF INTERNAL
MEDICINE COUNCIL AND THE ABIM
INFECTIOUS DISEASE SPECIALTY
BOARD.
ORIGINALLY FROM SCRANTON,
PENNSYLVANIA, WHICH I LEARNED
THIS SPRING, DR. MARRAZZO
GRADUATED FROM HARVARD
UNIVERSITY.
SHE EARNED HER M.D. FROM THOMAS
JEFFERSON UNIVERSITY, AND HER
M.P.H. IN EPIDEMIOLOGY FROM THE
UNIVERSITY OF WASHINGTON,
SEATTLE.
SHE COMPLETED HER RESIDENCY AND
CHIEF RESIDENCY IN INTERNAL
MEDICINE AT YALE NEW HAIIVE
HOSPITAL.
NEW HAVENHOSPITAL.
SHE'S A FELLOW OF THE AMERICAN
COLLEGE OF PHYSICIANS AND OF THE
INFECTIOUS DISEASES SOCIETY OF
AMERICA AND SHE'S BOARD
CERTIFIED IN INFECTIOUS
DISEASES.
I'M SO HONORED AND PROUD TO HAVE
HER AS A COLLEAGUE.
TODAY, DR. MARRAZZO WILL BE
GIVING US AN UPDATE ON NIAID'S
PRIORITIES FOR RESEARCH IN WOMEN
AND CHILDREN.
OVER TO YOU, GENIE.
, JEANNE.
>> THANK YOU SO MUCH, DIANA.
CAN YOU ALL HEAR ME OKAY?
GREAT.
I'M GOING TO JUMP RIGHT IN AND
START SHARING MY SLIDES AND
HOPEFULLY THIS WILL WORK.
LOOKS LIKE HOPEFULLY YOU GUYS
CAN ALL SEE THAT.
SO IT'S JUST A HUGE HONOR TO BE
ABLE TO SPEAK WITH YOU TODAY.
I HOPE THAT WE HAVE TIME FOR AT
LEAST A COUPLE OF QUESTIONS IF
PEOPLE HAVE ANY, ALTHOUGH I DO
HAVE A LOT TO SAY BECAUSE WE
HAVE A LOT OF PRIORITIES FOR
RESEARCH IN WOMEN AND CHILDREN,
AND IT'S BEEN A REAL PLEASURE
GETTING TO KNOW THE NICHD TEAM A
BIT MORE AS I HAVE STARTED IN
THIS ROLE.
SO JUST BECAUSE I DON'T KNOW
MANY OF YOU, I'LL GIVE YOU A
VERY BRIEF BACKGROUND, ALTHOUGH
DIANA VERY KINDLY JUST GAVE YOU
SOME OF THE HIGHLIGHTS AT LEAST
OF WHERE I'VE SPENT MY TIME, BUT
THE BOTTOM LINE IS THAT I HAVE
BEEN INTERESTED IN WOMEN'S
HEALTH FOR A REALLY LONG TIME.
IT MAY HAVE STARTED WITH MY MOM,
WHO IS A RETIRED NURSE, THAT'S A
PHOTO OF HER WORKING AT AN ARMY
HOSPITAL IN ITALY, LIVORNO,
WHICH ACTUALLY IS WHERE I WAS
BORN, AND SHE WAS AN ONCOLOGY
NURSE IN THE LATE 80s IN
SCRANTON, MID TO LATE 80s,
ACTUALLY, AND STARTED TAKING
CARE OF A LOT OF YOUNG MEN WHO
WERE RETURNING HOME FROM THE BIG
CITIES LIKE NEW YORK AND
PHILADELPHIA MOSTLY, WHO WERE
DYING OF HIV AND CAME HOMEY
SENHOMEESSENTIALLY TO DIE, AND D
ON ME VERY EARLY THE NEED TO
PROVIDE COMPASSIONATE CARE,
BECAUSE MANY PROVIDERS AT THAT
TIME WERE REFUSING TO TAKE CARE
OF THESE PATIENTS, AND OBVIOUSLY
AT THAT POINT, AIDS CARE WAS
HOSPICE CARE, TOWARDS THE END OF
LIFE, AND SO ONCOLOGISTS DID
HOSPICE CARE AND THAT'S HOW MY
MOM GOT INVOLVED.
SO REALLY WAS INFORMED JUST IN
TERMS OF KIND OF COMPASSIONATE
CARE AND OUTREACH, AND MY MOM
DOING HER SOCIAL JUSTICE THING
IN HER QUIET WAY.
SO REALLY INFORMED A LOT OF
WHERE I ENDED UP GOING IN MY
RESIDENCY IN NEW HAVEN, LOTS OF
WOMEN AFFECTED BY HIV.
VERY MUCH A MICROCHASM OF
TRANSMISSION KIND OF NETWORK
THAT WAS SIMILAR TO WHAT WE SAW
IN SUB-SAHARAN AFRICA IN
SUBSEQUENT YEARS.
SO I WAS VERY FORTUNATE TO HAVE
TRAINED AT YALE AND TO GET
INVOLVED VERY EARLY WITH HIV
CARE, PARTICULARLY AS IT RELATED
TO WOMEN.
SPENT MOST OF MY CAREER THEN AT
THE UNIVERSITY OF WASHINGTON,
WHERE I DID STUDY QUITE A LOT OF
STIs AND GOT A REALLY BIG
START IN MY RESEARCH WORLD IN
THE VAGINAL MICROBIOME WORKING
WITH DAVID FREDERICKS AND HIS
TEAM AT THE FRED HUTCH, AND WE
WERE AMONG THE FIRST TO REALLY
DEFINE THE SPECTRUM,
PARTICULARLY ANAEROBIC
COMMUNITIES THAT CHARACTERIZE
THE VAGINAL MICROENVIRONMENT SO
USING 16S CULTIVATION,
INDEPENDENT TECHNIQUES, AND GOT
VERY INVOLVED WITH BOTH TOPICAL
AND SYSTEMIC BASED PRE-EXPOSURE
PROPHYLAXIS FOR HIV AND STILL
HAVE A VERY STRONG INTEREST IN
ITS EVOLUTION TOWARDS
MULTICOMPONENT PREVENTION, WHICH
IS AN AREA THAT WE HAVE BEEN
INSTITUTIONALLY, BOTH OF OUR
INSTITUTES, VERY INVOLVED IN,
I'LL COME BACK AND TALK ABOUT
THAT IF WE HAVE TIME.
IN 2016, I DID GO TO THE
UNIVERSITY OF ALABAMA AT
BIRMINGHAM, WHERE I WAS THE
DIVISION DIRECTOR UNTIL I CAME
HERE TO BEGIN MY TENURE AS THE
SIXTH NIAID DIRECTOR IN THE FALL
OF 2023.
AND THAT IS MY SWEARING IN
CEREMONY.
JUST TO GIVE YOU A SENSE OF A
COUPLE OF BIG PEOPLE ON MY TEAM,
MANY OF YOU MAY HAVE WORKED WITH
OR KNOW DR. HUGH AUCHINCLOSS.
HE WAS DR. FAUCI'S PRINCIPAL
DIRECTOR -- DEPUTY DIRECTOR FOR
MANY YEARS, AND THEN THE ACTING
DIRECTOR OF NIAID WHEN I CAME ON
TO THIS ROLE.
HE RETIRED LAST SEPTEMBER, AFTER
STAYING ON MANY EXTRA MONTHS
JUST TO MAKE THE JOB POSSIBLE
FOR ME, WAS REALLY AN INCREDIBLE
HELP IN THE TRANSITION, AND
WE'VE BEEN VERY FORTUNATE TO
HAVE DR. SARAH READ NOW JOIN WHO
BECAME THE NEW DEPUTY DIRECTOR
IN OCTOBER '24.
YOU MAY KNOW HER IF YOU HAVE
DONE ANY WORK IN THE FIELD OF TB
OR HIV.
SHE WAS THE DEPUTY DIRECTOR IN
THE DIVISION OF AIDS FOR SEVERAL
YEARS, AND HAS A VERY STRONG
INTEREST IN TB VACCINES IN
PARTICULAR.
SO REALLY NICELY BUILDING UP THE
FRONT OFFICE TEAM HERE.
SO WHAT DO WE DO HERE AT NIAID?
WELL, THE SORT OF ON PAPER
MISSION IS SHOWN THERE.
BIOMEDICAL RESEARCH TO BETTER
UNDERSTAND AND TREAT INFECTIOUS,
IMMUNOLOGIC AND ALLERGIC
DISEASES.
REMEMBER ALLERGY IS PURPOSELY IN
THAT DESCRIPTION AND I'M GOING
TO TALK TO YOU ABOUT A COUPLE OF
REALLY GOOD HIGH POINTS, I
THINK, THAT MAKE SENSE.
AND IF YOU LOOK AT THIS FROM THE
STANDPOINT OF WHERE WE SORT OF
SPEND MOST OF OUR TIME AND MOST
OF OUR RESOURCES, IT REALLY
TURNS OUT TO BE DIVIDED MOSTLY
LIKE THIS, ABOUT A THIRD OF OUR
BUDGET AND TIME, IMMUNOLOGIC
DISEASES INCLUDING ALLERGY AND
ALLERGIC PHENOMENON, ABOUT A
THIRD IN HIV-RELATED RESEARCH
OFTEN REALLY DUE TO SOME OF THE
MANDATES WE HAVE AROUND SPENDING
HIV FUNDS, AND THEN THE REST OF
IT IN EVERYTHING ELSE
INFECTIOUS.
SO THAT'S NOT HIV-RELATED.
AND YOU CAN SEE THAT SOME OF THE
TOPICS IN EACH OF THOSE AREAS
THAT WE HAVE FOCUSED ON IN THE
PAST SEVERAL YEARS ARE SHOWN
THERE.
BUT WHAT I LIKE TO TELL PEOPLE
IS THAT THIS IS A ENTITY THAT
HAS NOT JUST LED MUCH OF THE
BASIC SCIENCE LABORATORY-BASED
RESEARCH, BUT IN THE FIELD, BUT
REALLY INFORMS PUBLIC HEALTH
INTERVENTIONS, AND WE'VE LISTED
A FEW OF THE DEVELOPMENTS THAT I
THINK ARE VERY INTERESTING TO
THIS GROUP HERE ON THIS SLIDE.
SO FOR EXAMPLE, BARNEY GRAM'S
GROUP WAS THE FIRST TO LOCK THE
RSV F PROTEIN IN WHAT'S CALLED A
PREFUSION STATE, WHICH IS WHAT
YOU NEED TO DO IN ORDER TO
GENERATE A PROTECTIVE IMMUNE
RESPONSE WITH A VACCINE.
THAT TECHNOLOGY, OF COURSE, ALSO
WAS USED FOR SARS-COV-2, THE
REASON THAT WE WERE ABLE TO
GENERATE EFFECTIVE VACCINES
AGAINST SARS-COV-2 AND THAT'S
VERY MUCH OF INTEREST, I KNOW,
TO WOMEN WHO ARE PREGNANT IN
PARTICULAR AS WELL AS AGING
PEOPLE.
THE LEARNING EARLY ABOUT PEANUT
ALLERGY TRIAL RESULTS, I'M GOING
TO TALK ABOUT THAT BECAUSE IT'S
A REALLY COOL STORY OF HOW YOU
CAN DO THE BASIC SCIENCE WORK,
DESIGN CLINICAL TRIALS AND THEN
TRANSLATE THOSE INTO REALLY
MEANINGFUL UPDATED GUIDELINES.
YOU PROBABLY HAVE HEARD ABOUT
LENOCAPOVIR, WHICH IS AN
INCREDIBLE ADVANCE IN THE FIELD
OF BIOMEDICAL HIV PREVENTION.
IT'S AN EVERY SIX MONTH
INJECTION THAT SEEMS TO BE I
WON'T SAY FULL PROOF BUT PRETTY
CLOSE AT PREVENTING ACQUISITION
OF HIV SEXUALLY IN VERY DIVERSE
POPULATIONS.
WE WERE VERY INVOLVED IN THE
FIRST SORT OF ITERATION OF THAT
GROUP OF PRODUCTS CALLED
CABOTEGRAVIR, HAVE A LOT OF
FINGERPRINTS THERE, THEN OF
COURSE IN TRANSPLANT MEDICINE,
WE HAVE A DIVISION OF ALLERGY,
IMMUNOLOGY AND TRANSPLANT, AND
THE MILESTONE OF THE XENO
TRANSPLANTATION INVOLVING THE
PIG KIDNEY THAT OCCURRED LAST
YEAR WAS VERY MUCH INFORMED BY
WORK DONE BY OUR GRANTEES AND IN
OUR INSTITUTE.
SO JUST A COUPLE OF THINGS.
AND THEN, OF COURSE, WHEN YOU
LOOK AT THE EFFECT OF
IMMUNIZATION, IT'S HARD AND I
KNOW THIS GROUP IS EX-WIS ITALY
ATTUNED TO THIS CONTRIBUTION,
IT'S HARD TO UNDERSTATE THE
IMPACT OF THE WORK THAT WE AND
SO MANY PEOPLE HAVE DONE TO
IMPROVE PARTICULARLY CHILDHOOD
HEALTH.
AND HEALTH DURING PREGNANCY WITH
THESE VACCINES.
AND I WOULD JUST POINT OUT WHAT
I THINK IS AN INCREDIBLY USEFUL
PUBLICATION CAME OUT IN THE
LANCET LATE LAST YEAR THAT
LOOKED AT MULTIPLE METRICS OF
THE IMPACT OF IMMUNIZATION
PROGRAMS INCLUDING ON THIS GRAPH
DEATHS AVERTED, YEARS OF LIFE
SAVED, AND YEARS OF FULL HEALTH
GAINED BY VACCINATION.
I AM NOT SURE YOU CAN SEE AT THE
TOP, BECAUSE MY LITTLE THING IS
UNFORTUNATELY COVERING IT, BUT
EACH OF THESE COLORS REPRESENTS
A DIFFERENT PATHOGEN THAT HAS
BEEN TARGETED AND YOU CAN SEE
HOW MANY LIFE YEARS GAINED, ET
CETERA, HAVE OCCURRED IN JUST
THE LAST 50 YEARS AND IT'S
REALLY BEEN PRETTY ASTONISHING.
SO IT'S NOT JUST THE OLD DAYS OF
VACCINE ADVANCES, BUT ACTUALLY
PRETTY RECENTLY.
SO I'LL SHIFT VERY QUICKLY
BECAUSE I WANT TO TALK ABOUT OUR
NEW STRATEGIC PLAN WHICH IS
HOPEFULLY GOING TO COME OUT IN
THE NEXT MONTH OR SO, AND WHAT
WE'RE THINKING ABOUT FOR THE
FUTURE.
SO WE HAVE BEEN PROBABLY BY
NECESSITY A VERY
PATHOGEN-FOCUSED GROUP.
PEOPLE HAVE THEIR LABS BUILT
AROUND PATHOGENS, PEOPLE HAVE
THEIR FAVORITE PATHOGENS, BUT
WHAT I LIKE TO REALLY TALK ABOUT
AND THINK ABOUT IS MORE OF A
WHOLE PERSON APPROACH TO
INFECTIOUS DISEASES BECAUSE
PEOPLE GET INFECTIONS, THEY
AREN'T INFECTIONS, RIGHT?
SO YOU CAN TALK ABOUT PEOPLE
LIVING WITH HIV, BUT PEOPLE
LIVING WITH HIV ALSO GET
TUBERCULOSIS, THEY HAVE
METABOLIC DISORDERS, THEY WANT
TO GET PREGNANT, THEY WANT TO
HAVE HEALTHY BABIES.
SO WE ARE REALLY TRYING TO THINK
ABOUT THIS CONCEPT OF
UNDERSTANDING HUMAN IMMUNOLOGY,
PREVENTING ABERRANT RESPONSES,
FOR EXAMPLE, AUTOIMMUNITY, FOOD
ALLERGY, AND THINKING ABOUT HOW
WE ENHANCE OUR NATURAL DEFENSES
ALL IN THE SETTING OF CONTINUING
TO DEVELOP MEDICAL
COUNTERMEASURES FOR
BIOPREPAREDNESS AND FOR OTHER
EVENT ACTUALIT
EVENTUALITIES.
IT'S ALSO IMPORTANT TO MENTION
TOO THAT H WE HAVE A BIG IMPACT
ACROSS THE UNITED STATES.
DIANA MENTIONED OUR VERY
GENEROUS BUDGET WHICH I'LL SHOW
YOU A LITTLE BIT MORE ABOUT IN A
MINUTE BUT WE DISTRIBUTE MOST OF
THAT OUTSIDE THE NIH, SO OVER
$5 BILLION DISTRIBUTED ACROSS
THE U.S. IN FISCAL YEAR 2023.
THE OTHER THING I WANT TO
MENTION IS THAT WE ARE REALLY
FOCUSED RIGHT NOW ON OUR
WORKFORCE.
WE HAVE NOT HAD A GREAT TRACK
RECORD IN THE LAST FIVE YEARS,
AND THE PANDEMIC HAD A LOT TO DO
WITH THAT, TO BE HONEST, FOR
REASONS WE CAN TALK ABOUT IF WE
HAD TIME.
GETTING PEOPLE INTO INFECTIOUS
DISEASES, EITHER AS CLINICIANS
OR AS PHYSICIAN SCIENTISTS, OR
AS BASIC RESEARCHERS OR
TRANSLATIONAL RESEARCHERS.
SO WE HAVE BEEN REAL FOCUSED ON
TRYING TO SUPPORT RESEARCHERS
THROUGHOUT THE CAREER SPAN
BECAUSE IF WE CAN'T DO THAT,
WE'RE NOT GOING TO BE ABLE TO
CARRY OUT ANY OF THE MISSION
ITEMS THAT ARE SHOWN ON THIS
SLIDE.
AND ONE OF THE THINGS THAT I
FOUND WHEN I CAME HERE WAS THAT
WE AS AN INSTITUTE DESPITE OUR
VERY GENEROUS BUDGET HAVE NOT
REALLY KEPT UP WITH
PROPORTIONATELY FUNDING
TRAINING, AND OF COURSE THAT WAS
EXACERBATED BY THE NEED TO FOCUS
ON THE PANDEMIC IN THE LAST FIVE
YEARS.
SO THIS IS JUST TO POINT OUT
THAT WE HAVE COMMITTED TO
INCREASING OUR ALLOCATION FOR
OUR TRAINING BUDGET.
THESE ARE JUST TRENDS THROUGH
THE LAST SEVERAL YEARS AND AGAIN
THIS DOES INCLUDE THE PANDEMIC
WHICH HAS BEEN A CHALLENGING
TIME, BUT WE HAVE BEEN ABLE TO
INCREASE IT AND WE ARE PLANNING
TO DO SO ASSUMING THAT WE
CONTINUE TO HAVE THE BUDGET THAT
WE HAVE REQUESTED.
NOW IS THAT GOING TO HAPPEN?
WE REALLY DON'T KNOW.
THIS IS OUR FUNDING HISTORY FROM
2000 TO 2025.
AND WE HAVE HAD A NUMBER OF
INCREASES OFTEN RELATED TO
THREATS, FOR EXAMPLE, AROUND
2001 AND BIOPREPAREDNESS WITH
THE ANTHRAX EVENTS POST 9/11,
AND WITH VARIOUS OUTBREAKS, FOR
EXAMPLE, VIRAL HEMORRHAGIC
FEVERS LIKE EBOLA, AS WELL AS
THE PANDEMIC FLU IN 2009.
SO WE HAVE HAD VERY, VERY GOOD
BIPARTISAN SUPPORT FROM OUR
APPROPRIATORS.
THIS YEAR, WE ACTUALLY HAVE A
BUDGET REQUEST FROM THE
PRESIDENT THAT WAS STABLE,
SLIGHTLY OVER OUR FISCAL YEAR
2024, AND VERY SIMILAR IN THE
SENATE, AND TO I THINK OUR GREAT
RELIEF, ALSO SIMILAR IN THE
HOUSE.
WHEN I TOOK THIS JOB IN THE FALL
OF 2023, THE HOUSE PROPOSED A
CUT OF 23.9% FOR NIAID AND THAT
WAS VERY SPECIFIC TO US.
IT WAS NOT DIRECTED TOWARDS
OTHER INSTITUTES.
THIS YEAR, THEY DID NOT, WHICH I
AM VERY, VERY, VERY GRATEFUL
FOR.
THEY DID PROPOSE SPLITTING US
INTO TWO INSTITUTES, THE
NATIONAL INSTITUTE ON INFECTIOUS
DISEASES, AND THE NATIONAL
INSTITUTE ON THE IMMUNE SYSTEM
AND ARTHRITIS.
SO THERE IS THAT TO WORK
THROUGH.
AND AS I THINK EVERYBODY KNOWS,
WE ARE ON A CONTINUING
RESOLUTION THROUGH MARCH 14TH.
SO THIS IS JUST A SNAPSHOT OF
WHAT THOSE PROPOSALS LOOK LIKE
AND WHERE WE STAND.
AS DIANA MENTIONED, WE ARE
SECOND ONLY TO THE NATIONAL
CANCER INSTITUTE AND THIS IS THE
HOUSE AND THE SENATE BUDGET AND
THIS IS WHAT WE HAD LAST YEAR.
SO WE WILL SEE WHAT HAPPENS AND
HOPE THAT WE CAN CONTINUE TO DO
WHAT WE NEED TO DO WITH THE
RESOURCES THAT WE NEED.
WE HAVE PRETTY ROBUST FUNDING
THAT IS TRACEABLE AND ACTIONABLE
TO PEDIATRIC FOCUS.
AGAIN, A HUGE FOCUS OF THIS
GROUP, OF COURSE, SO IF YOU LOOK
AT OUR FUNDING FROM 2008 TO TWEP
23, WE HAVE HAD A PRETTY
SUSTAINED INCREASE AND IN FACT
ALMOST A THREE FOLD INCREASE
SINCE 2008, WHICH I THINK IS
REALLY QUITE REMARKABLE AND
VERY, VERY WELL-DESERVED AND
INDICATED.
THESE DECLINES WERE REALLY MORE
RELATED TO PANDEMIC
REDISTRIBUTION, NOT TO ANY LOSS
OF COMMITMENT TO OUR EFFORTS IN
THIS AREA.
SO WHERE HAS THIS GOTTEN US?
I JUST WANT TO HIGHLIGHT A FEW
ADVANCES THAT I THINK ARE BOTH
AMAZING AND ALSO INDICATIVE OF
THE KIND OF WORK WE CAN GET DONE
WHEN WE WORK TOGETHER AS
INSTITUTES.
SO I MENTIONED THE LEARNING
EARLY ABOUT PEANUT ALLERGY
TRIAL, THE LEAP TRIAL.
THIS IS ACTUALLY THREE TRIALS
WHICH HAVE BEEN DESIGNED AND
BUILT ON EACH OTHER OVER DECADES
NOW.
WHICH IS I THINK A GREAT EXAMPLE
AGAIN OF WHAT YOU CAN DO WITH A
STABLE BASE OF FUNDING, STABLE
LEADERSHIP COMMITMENT TO SEEING
A PROBLEM THROUGH ALL THE
TRANSLATIONAL ASPECTS OF WHAT
YOU FIND AS YOU GO ALONG.
SO THE FIRST STUDY CAME OUT IN
THE NEW ENGLAND JOURNAL IN 2015
AND MANY OF YOU KNOW ABOUT THIS.
BUT THIS BASICALLY SHOWED TO
MANY PEOPLE THE SURPRISING
FINDING THAT EARLY INTRODUCTION
OF PEANUT PRODUCTS ACTUALLY
REDUCED THE RISK OF PEANUT
ALLERGY AT AGE 5 BY A STAGGERIG
81%.
SO THIS WAS A GOOD IDEA TO GET
KIDS DONE.
THEN THE QUESTION BECAME HOW
LONG DID THAT LAST, AND WHAT
COULD YOU DO TO CONTINUE TO
BUILD ON THAT.
THE LEAP ON STUDY SHOWED THAT
THE PEOPLE IN THE EARLIER STUDY
WHO WERE IN THE CONSUMPTION
GROUP REMAINED PROTECTED AT AGE
6 EVEN AFTER THEY AVOIDED PEANUT
PRODUCT FOR ONE YEAR.
SO THE LEAP TRIO STUDY WHICH WAS
JUST PUBLISHED LAST YEAR SHOWED
THAT PEANUT CONSUMPTION FROM
INFANCY TO AGE 5 YEARS PROVIDED
LASTING TOLERANCE TO PEANUT --
ADOLESCENCE IRRESPECTIVE OF
PEANUT CONSUMPTION.
SO WHY IS THIS A BEAUTIFUL
THING?
BECAUSE AGAIN, YOU'VE GOT A
COHORT THAT HAS PARTICIPATED IN
THESE STUDIES FROM INFANCY TO
ADOLESCENCE, AND ALMOST 80% OF
THE ORIGINAL LEAP STUDY
PARTICIPANTS WERE ENROLLED IN
LEAP TRIO.
SO THIS IS WHAT AGAIN STABLE
RESOURCES, ALLOCATION, STABLE
COMMITMENT AND REALLY SCIENTIFIC
VISION THAT ADDRESSES CONCERNS
OVER THE LIFESPAN AS PEOPLE
MATURE CAN GET YOU SO I REALLY,
REALLY LIKE THAT STUDY.
ON THE OTHER END OF THE
SPECTRUM, YOU'VE GOT THE VERY
RARE DISEASES THAT WE SEE A ANDD
TAKE CARE OF PARTICULARLY IN THE
CLINICAL CENTER HERE AT NIH, AND
I JUST WANT TO GIVE YOU AN
EXAMPLE OF HOW OUR CLINICAL
GENOMICS PROGRAM HAS MADE SOME
REALLY SIGNAL DISCOVERIES.
THE EXAMPLE I WILL TALK ABOUT
VERY BRIEFLY IS CHAPEL SYNDROME.
YOU MAY BE FAMILIAR WITH THIS.
THIS IS CAUSED BY A CD55
DEFICIENCY THAT RESULTS IN
ABNORMAL COMPLEMENT ACTIVATION.
YOU GET BIALELIC LOSS OF
FUNCTION MUTATIONS IN THE CD55
GENE AND SO YOU LOSE PROTEIN
EXPRESSION.
IF IT'S NOT FIXED, PATIENTS DIE
OF STARVATION BEFORE 30 YEARS
OLD.
IT'S A REALLY, REALLY
DEVASTATING CONDITION, LARGELY
BECAUSE OF A PROTEIN LOSING
ENTEROPATHY, BUT THEY ALSO GET
ANGIOPATHIC THROM POEISIS
BECAUSE OF THE COMPLEMENT
DYSFUNCTION.
SO THE DISCOVERY OF THE GENE
ASSOCIATED WITH CHAPLE SYNDROME
WAS MADE, WE HAD A SERIES OF
PATIENTS HERE THAT WE THEN
SEQUENCED AND FIGURED OUT
EXACTLY WHAT WAS GOING ON.
THAT LED TO A TRIAL OF A DRUG
CALLED POZELIMAB WHICH INHIBITS
COMPLEMENT OVERACTIVATION AND
ESSENTIALLY RESOLVES
MANIFESTATIONS OF CHAPLE
DISEASE, SO DEFINED HERE IN 2017
IN THE NEW ENGLAND JOURNAL,
LOOKING AT THAT DRUG IN 2024
JUST LAST YEAR PUBLISHED IN THE
LANCET, AND THEN RESULTING IN
THE FDA APPROVING THAT DRUG, AND
THIS IS JUST A PICTURE OF A
CHILD BORN WITH CHAPLE DISEASE
BEFORE AND AFTER TREATMENT WITH
THIS DRUG.
SO TO ME, IT DOESN'T REALLY GET
ANY BETTER THAN THIS.
IT'S AN AMAZING TESTAMENT TO THE
CAPACITY THAT WE HAVE TO DO
THESE KINDS OF VERY
SOPHISTICATED STUDIES AND THEN
PURSUE THE FINDING TO DEVELOP AN
INTERVENTION THAT ULTIMATELY CAN
BENEFIT PEOPLE.
WE HAVE MANY EXCITING, I THINK,
OTHER ACTIVITIES THAT ARE
EXTREMELY IMPORTANT FOR BOTH OF
OUR INSTITUTES AND I THINK THE
OTHER ONE THAT I'LL JUST
HIGHLIGHT IS THE IMPAACT
NETWORK, ONE OF OUR HIV-RELATED
NETWORKS, THE INTERNATIONAL
MATERNAL PEDIATRIC ADOLESCENT
AIDS CLINICAL TRIAL NETWORK.
THAT'S BEEN AROUND NOW FOR AT
LEAST I THINK 20 YEARS, IF I'M
NOT MISTAKEN.
A COUPLE OF REALLY EXCITING
DEVELOPMENTS IN THIS AREA ARE
SHOWN HERE.
OBVIOUSLY WE ARE LOOKING AT NEW
AGENTS FOR PREVENTION AND
TREATMENT OF HIV IN NEONATES IN
PARTICULAR, AND THE EXAMPLE IN
THE LEFT-HAND SIDE HIGHLIGHTS
DOLUTEGRAVIR THAT'S INCREASINGLY
USED GLOBALLY FOR THE TREATMENT
OF HIV, AND ACTUALLY WAS IN
SOUTH AFRICA IN AUGUST AND GOT
TO SEE A COUPLE OF INFANTS
ENROLLED IN THIS AND TO SEE
PEOPLE DOING INTENSIVE
PHARMACOKINETIC STUDIES ON THESE
BABIES WITH THEIR MOMS IN THESE
SETTINGS WAS REALLY PRETTY
REMARKABLE.
THE OTHER SORT OF TANGIBLE THING
THAT CAME OUT QUITE RECENTLY
APPROVAL FROM THE EUROPEAN
MEDICINES AGENCY APPROVING
TRIUMEQ IN CHILDREN LIVING WITH
HIV, SO SAFE, WELL TOLERATED AND
VERY EFFECTIVE.
SO THESE STUDIES ARE HARD TO DO
AS YOU KNOW.
IT'S HARD TO DO STUDIES IN
CHILDREN IN GENERAL BUT WHEN YOU
LOOK AT WHERE WE NEED TO DO
THESE AND HOW CHALLENGING SOME
OF THE OTHER CONCOMITANT
CONDITIONS ARE, IT'S REALLY, I
THINK, AGAIN A TESTAMENT TO
PEEP'S COMMITMENT TO MAKE THIS
HAPPEN.
I WANT TO SAY A WORD ABOUT
MALARIA, AND MANY OF YOU KNOW
THAT MALARIA IS A HUGE KILLER OF
CHILDREN, SO CEREBRAL MALARIA IN
PARTICULAR IS OFTEN FATAL IN
YOUNG CHILDREN AND ALSO VERY
PROBLEMATIC IN PREGNANCY.
IT'S A HUGE -- WELL, I DON'T
KNOW IF IT'S A HUGE CAUSE BUT
IT'S A SIGNIFICANT CAUSE OF
SPONTANEOUS ABORTION,
MISCARRIAGE, AS WELL AS EARLY
PREGNANCY.
SO LOTS GOING ON THERE WITH THE
MATERNAL PLACENTAL INTERFACE IN
THE SETTING OF MALARIA INFECTION
DURING PREGNANCY.
WE HAVE DEVELOPED IN OUR
INTRAMURAL PROGRAM A SERIES OF
NON-CLONAL ANTIBODIES THAT ARE
AIMED AT A HIGHLY CONSERVED AREA
OF THE PLASMODIUM FALCIPARUM
PROTEIN WHICH IS THE PREHEPATIC
PHASE, SO THIS IS WHAT GETS
INJECTED INTO YOU WHEN THE
MOSQUITOES BITE YOU.
THE IDEA OF THIS MONOCLONAL IS
TO TRY TO BIND THAT PROTEIN
BEFORE THE PATHOGEN HAS THE
OPPORTUNITY TO INFECT THE LIVER.
THAT WAY, YOU'RE DEALING WITH A
COUPLE OF HUNDRED PARASITES IF
THAT, AS OPPOSED TO MILLIONS OF
PARASITES ONCE YOU'VE GOT THE
HEPATIC PHASE ESTABLISHED.
SO THIS IS JUST A REALLY NICE
STUDY DONE WITH OUR COLLEAGUES
DONE IN CHILDREN 6 TO 10 YEARS
OF AGE WHERE WE LOOKED AT THE
EFFICACY OF A SINGLE SUBQ
INJECTION OF THIS MONOCLONAL
ANTIBODY, AND SHOWED AS YOU CAN
SEE IN THIS SLIDE THAT DEPENDING
ON THE DOSE USED, THERE WAS AN
EFFICACY OF BETWEEN 66 AND 77%.
WHETHER YOU LOOKED AT THE FIRST
INCIDENCE OF MALARIA AS DEFINED
BY BLOOD SMEARS OR WHETHER YOU
LOOKED AT CLINICAL EVIDENCE OF A
MALARIA EPISODE.
SO -- AND WHY DOES IT LAST SO
LONG?
BECAUSE THE ANTIBODY IS DESIGNED
SPECIFICALLY TO PROVIDE
APPROXIMATELY 6 MONTHS OF
PROTECTION.
WHY?
BECAUSE THAT'S THE DURATION OF
THE MALARIA SEASON, RIGHT?
IF YOU CAN GET PEOPLE THROUGH
THE RAINY SEASON, SEASON WHERE
THE MOSQUITOES ARE REALLY
REPLICATING AND BITING PEOPLE,
THEN YOU CAN ACTUALLY MAKE A
MAJOR DENT.
SO THIS IS PRETTY EXCITING AND
REALLY, REALLY COOL TO SEE THIS.
SO HOW CAN WE COLLABORATE, HOW
CAN WE CONTINUE TO GROW THIS?
JUST A FEW THOUGHTS HERE.
IF YOU KNOW ME, YOU KNOW THAT I
AM INTERESTED IN SEXUALLY
TRANSMITTED INFECTIONS AND HAVE
WATCHED WITH SOME HORROR AS WE
WENT FROM HAVING NO CONGENITAL
SYPHILIS INFECTIONS IN THE
UNITED STATES DURING MY TRAINING
AND DURING MOST OF MY CAREER TO
STARTING TO SEE A BIT IN THE
EARLY 2000s TO THE POINT WHERE
IF 2022, AND IN 2023, WE HAD
OVER 3700 SYPHILIS CASES IN THE
UNITED STATES WITH SEVERAL
HUNDRED DEATHS DUE IN NEONATES
TO SYPHILIS.
SO LOTS OF THINGS TO THINK ABOUT
HERE.
IT IS DEFINITELY SOMETHING THAT
WE NEED TO UNDERSTAND IN TERMS
OF, AGAIN, WHAT IS CAUSING THE
BIOPATHOLOGY.
WE STILL REALLY DON'T UNDERSTAND
VERY MUCH ABOUT CONGENITAL
SYPHILIS.
NOT SURPRISING BECAUSE IT WAS
GONE FOR SO LONG OR MOSTLY GONE,
SO WE'VE FUNDED SOME RESEARCH TO
START LOOKING AGAIN AT SOME OF
THE PLACENTAL INTERACTIONS TO
LOOK AT TREATMENT IN PREGNANCY,
BUT I JUST WANT TO POINT OUT
THAT WE ARE ALSO VERY INTERESTED
IN SOME OF THE IMPLEMENTATION
SCIENCE AROUND THIS.
WHEN YOU START LOOKING AT WHY
CONGENITAL SYPHILIS HAPPENS,
IT'S NOT JUST AS SIMPLE AS, OH,
PEOPLE DIDN'T GET TREATED.
THEY'RE ALL THE REASONS THAT
PEOPLE DIDN'T GET TREATED,
THEY'RE ALL THE REASONS THAT
PEOPLE DIDN'T COMPLETE
TREATMENT.
SO REALLY, REALLY COMPLICATED,
AND JUST POINTING OUT THIS NICE
STUDY THAT IS PART OF OUR
PORTFOLIO OF FUNDING WHERE THESE
INVESTIGATORS OFFERED OPTIONAL
SYPHILIS TESTS TO MOST PEOPLE
SEEKING CARE AT A LARGE
EMERGENCY DEPARTMENT, AND JUST
THIS SIMPLE INTERVENTION
DRAMATICALLY INCREASES, YOU CAN
SEE IN RED HERE, THE PROPORTION
OF PEOPLE SCREENED AND THAT WAS
ESPECIALLY TRUE FOR PREGNANT
WOMEN.
SO PREGNANT PATIENTS OR PREGNANT
PEOPLE.
SO LOOK AT THIS, THIS IS WHEN
THE INTERVENTION STARTED IN
APRIL/MAY OF 2019, VERY FEW
PEOPLE WHO WERE PREGNANT WERE
SCREENED BEFORE THAT, WHICH IS
KIND OF SHOCKING IF YOU DO THIS
WORK.
BUT THEN WHEN YOU GO HERE AND
YOU LOOK AT HOW MANY PEOPLE WERE
SCREENED, YOU SEE QUITE A BIG
INCREASE.
AND NOT ONLY WERE PEOPLE
SCREENED, WE ACTUALLY DETECTED,
THEY DETECTED INFECTIONS.
AND THIS IS JUST AN EXAMPLE OF
LOTS OF THE ENCOUNTERS THAT WERE
IMPACTED BY THIS OPPORTUNITY,
AGAIN, BEFORE THE INTERVENTION,
6% OF PREGNANT PEOPLE WERE
SCREENED, AFTER 50% WERE
SCREENED, AND THERE WAS A 750%
INCREASE IN CONFIRMED CASES.
NOW IT'S ONLY TWO CASES TO 15,
BUT THOSE ARE POTENTIAL LIFE
SAVING DETECTIONS.
AND I DON'T OVERSTATE THAT WHEN
YOU THINK ABOUT THE CONSEQUENCES
OF CONGENITAL SYPHILIS.
AND JUST OVERALL, YOU CAN TAKE A
LOOK AT THOSE NUMBERS HERE IF
YOU WANT TO -- REALLY CRITICAL,
MOST PEOPLE WITH SYPHILIS WHO
WERE PICKED UP IN THIS EFFORT
DID NOT EXHIBIT STI ESTIMATES.
I LIKE TO SAY IT'S HIGHLY LIKELY
THAT THEY WEREN'T REALLY EMAM
INNED -- HOW POOR GENITAL EXAMS
AND PELVIC EXAMS FOR THAT MATTER
ARE DONE IN THIS SETTING BUT
IT'S A REALLY NICE EXAMPLE OF
WHAT YOU CAN DO EVEN WITH SOME
IMPLEMENTATION OR TRANSLATIONAL
SCIENCE TO FIGURE OUT HOW TO GO
HERE.
WE HAVE ALSO DONE MUCH BETTER
WITH PREV PREVENTION OF VERTICAL
TRANSMISSION OF HIV.
WE STILL, HOWEVER, IN 2021,
SHOCKINGLY, GLOBALLY, SAW
160,000 NEW PERINATAL
INFECTIONS.
WHY IS THAT?
WELL, YOU MIGHT HAVE WHERE IS
THAT?
IT'S LARGELY IN THE COUNTRIES
THAT DID NOT HAVE PEPFAR.
SO THE ANSWER IS, IF YOU DON'T
HAVE ANTIRETROVIRAL THERAPY THAT
IS SUPPRESSIVE DURING PREGNANCY,
YOU'RE NOT GOING TO ATTAIN
SUPPRESSION OR ELIMINATION OF
VERTICAL TRANSMISSION OF HIV.
AND IF YOU LOOKED AT THOSE
INFECTIONS THAT OCCURRED IN
2021, YOU CAN SEE THAT WOMEN
DIDN'T KNOW THEIR STATUS, THEY
MIGHT HAVE ACQUIRED HIV DURING
PREGNANCY OR BREASTFEEDING WHICH
WE KNOW ARE HEIGHTENED TIMES OF
VULNERABILITY, THEY MIGHT HAVE
STOPPED THEIR ART OR THEY WERE
TAKING IT BUT THEY WEREN'T
SUPPRESSED.
SO THIS IS A MAJOR PUBLIC HEALTH
CHALLENGE, AND I JUST POINT IT
OUT BECAUSE WE CAN'T CONTINUE
LEAVING PREGNANT WOMEN OR WOMEN
WHO WANT TO GET PREGNANT AND
AREN'T CONTRASEPTEMBERRING CONTD
THIS IS JUST A NICE SLIDE THAT
MY COLLEAGUE MADE JUST TALKING
ABOUT ALL OF THE BIOMEDICAL
INTERVENTIONS THAT HAVE BEEN
LOOKED AT.
I MENTIONED LENACAPAVIR, THERE'S
CABOTEGRAVIR.
WE ACTUALLY HAVE A DIPIVIRINE
VAGINAL RING AND THERE ARE
REASSURING DATA FOR MANY OF
THESE INTERVENTIONS BUT FEW HAVE
BEEN STUDIED REALLY
SYSTEMATICALLY.
AN EXCEPTION IS THE DIPIVIRINE
RING, WHICH WOULD HAVE A VERY, I
WOULD SAY, TAILORED APPROACH TO
GETTING THIS STUDIED.
YOU KNOW, WE'RE TALKING ABOUT
BROADLY NEUTRALIZING ANTIBODY
THERAPY, MONOCLONAL ANTIBODY
THERAPY FOR HIV, REALLY NEED TO
START THINKING ABOUT HOW WE GET
WOMEN WHO ARE PREGNANT OR
PLANNING TO GET PREGNANT INTO
THESE STUDIES REALLY SOON.
SO IT'S REALLY ALSO REMARKABLE
THAT WE REALLY HAVE NOT FIGURED
THIS OUT YET GIVEN THAT WE DO
HAVE THE TOOLS.
WE DO HAVE GOOD GUIDELINES, AND
REMEMBER WE'VE DONE VERY WELL IN
THE UNITED STATES.
AND I WOULD SAY THAT THE VAST
MAJORITY OF -- ARE LEADING TO
THE OBSERVATION THERE THAT HIV
TRANSMISSION RISK IN THE U.S. IS
NOW DECREASED TO LESS THAN 1%.
BUT I WILL POINT OUT THAT,
AGAIN, HAVING COME FROM THE DEEP
SOUTH AND HAVING LIVED THERE FOR
SEVEN YEARS, AND EVEN IN
MARYLAND AND D.C. , YOU STILL
SEE CASES OF PERINATAL
TRANSMISSION OR I SHOULD SAY WE
STILL SEE CASES OF PERINATAL
TRANSMISSION.
I LIKE THIS SLIDE FROM THE
MARYLAND DEPARTMENT OF HEALTH
BECAUSE IT TAKES YOU THROUGH THE
AMAZING, AMAZING PROGRESS WE'VE
MADE SINCE THE MID 80s, BUT
THEN YOU GO TO 2020, 21, AND YOU
SEE HERE THIS LITTLE BUMP.
AGAIN, MANY OF THE
CHARACTERISTICS THAT DEFINE OR
CHARACTERIZE THE PEOPLE WHO ARE
AFFECTED ARE VERY SIMILAR TO
WHAT WE ARE SEEING WITH
CONGENITAL SYPHILIS.
SO IT SAYS AGAIN THAT THERE IS
NO MAGIC PILL, THERE IS NO MAGIC
SHOT.
THERE IS JUST A SUITE OF
INTERVENTIONS THAT REALLY NEED
TO TRY TO REACH THE PEOPLE WHO
CAN BENEFIT THE MOST FROM THIS.
A COUPLE OF OTHER THINGS I
WORKED ON REALLY CLOSELY WITH
NICHD, THE IMMUNE MECHANISMS AT
THE MATERNAL-FETAL INTERFACE.
I KNOW THIS IS A PROGRAM THAT
DIANA HAS BEEN PARTICULARLY
INTERESTED IN.
THIS IS AN EFFORT TO UNDERSTAND
THE INTERACTIONS OF IMMUNE CELLS
THAT ENABLE PREGNANCY AND
MODULATE IMMUNITY AND OFFSPRING
AND SO MANY DOMAINS AS ARE SHOWN
IN THAT GRAPHIC ARE PART OF THIS
EFFORT.
THE CORONAVIRUS DISEASE 2019
VACCINE RESPONSE IN PREGNANT AND
LACTATING WOMEN WAS A BEAUTIFUL
EXAMPLE OF REALLY THE NICHD TEAM
TAKING THE LEAD WITH US AND MANY
OTHERS TO STUDY VERY EARLY AND
VERY WELL THESE VACCINES IN A
VERY VULNERABLE POPULATION.
AND ALSO DOING SOME OF THE
PATHOBIOLOGIC ANCILLARY STUDIES
LOOKING AT, FOR EXAMPLE, THE
TRANSFER OF IMMUNITY TO NEONATES
AND HOW THAT HAPPENED, WHETHER
IT WAS THE PLACENTA OR BREAST
MILK.
WE ALSO HAVE A VERY COOL
TRANSLATIONAL RESEARCH IN MA
TERM AND PEDIATRIC PHARMACOLOGY
AND THERAPEUTICS PROGRAM.
THAT'S AN ANNOUNCEMENT THAT'S
BEEN ON THE STREET THAT'S
CO-SPONSORED BY THE INSTITUTE
SHOWN THERE, AND THE IDEA HERE
IS TO TRY TO GET BETTER
PRECISION THERAPEUTICS FOR THESE
POPULATIONS INCLUDING TOOLS,
MODELS AND OTHER TECHNOLOGIES.
ALSO LOOK AT UNDERLYING
MECHANISMS OF DRUG ACTION AND
ULTIMATELY TO MAKE SURE WE HAVE
A HEALTHIER PIPELINE FOR PRODUCT
THAT CAN BE USED IN THIS
SETTING.
SO JUST A FEW THINGS ABOUT WHAT
I WOULD LIKE TO SEE AND IN OUR
NEXT SORT OF FIVE YEARS IDEALLY,
I THINK WE CAN CONTINUE TO APPLY
GENOMICS TO TREAT PEDIATRIC
INFECTIOUS DISEASES.
THAT IS CERTAINLY BEING DONE TO
SOME EBBS TEN EXTENT IN OUR CLIL
CENTER BUT I THINK THERE ARE
MANY, MANY OPPORTUNITIES TO RAMP
THAT UP AND ALSO TO MAKE SOME OF
OUR RESOURCES AVAILABLE
POTENTIALLY TO EXTERNAL
INVESTIGATORS.
WOULD REALLY LIKE US TO SEE AN
ELIMINATION OF SOME OF THE MOST
DEVASTATING PERINATAL INFECTIOUS
DISEASE TRANSMISSIONS.
HIV, OF COURSE, COMES TO MIND
BUT NOW WE'VE GOT SYPHILIS TO
CONTEND WITH BUT THERE ARE
OTHERS AS WELL, OF COURSE.
REDUCING THE BURDEN OF CHILDHOOD
ASTHMA AND ALLERGY, WORKING
TOWARDS THAT, AND WE CANNOT
FORGET VACCINES.
CANNOT FORGET THE OUT SIZE
EFFECT THAT VACCINES HAVE HAD TO
ENHANCE SURVIVAL AS WELL AS THE
QUALITY OF LIFE OF OUR PEDIATRIC
PATIENTS.
AND OUR PREGNANT PATIENTS.
I'LL STOP HERE.
THIS IS A PHOTO I REALLY LOVE.
I VISITED THE CHILDREN'S INN
SEVERAL MONTHS AGO AND THIS IS A
PATIENT WHO CAME FROM OUT OF
STATE WITH HIS DAD TO SPEND
THEIR -- MANY VISIT OVER THE
YEARS, AND IT'S JUST AN
INCREDIBLE PRIVILEGE AND
OPPORTUNITY TO GET TO DO THAT.
SO I'LL STOP THERE.
I'M GOING TO STOP SHARING AND I
WILL TURN IT BACK OVER TO DIANA.
THANK YOU AGAIN.
>> THANK YOU, JEANNE.
THAT WAS A GREAT TALK AND REALLY
HIGHLIGHTED SOME OPPORTUNITIES
FOR COLLABORATION AND NEW AREAS.
I THINK WE HAVE TIME FOR ONE OR
TWO QUESTIONS, IF COUNCILMEMBERS
WOULD LIKE TO RAISE THEIR HANDS
OR COME ON THE CHAT?
IGNA.
>> YES, DR. MARRAZZO, THANK YOU
FOR THIS GREAT TALK.
YOU HIGHLIGHTED THE IMPORTANCE
OF IMPLEMENTATION SCIENCE
RESEARCH RELATED TO STI,
SYPHILIS AND PERINATAL HIV.
ONE IMPORTANT PROBLEM RIGHT NOW
IS VACCINE HESITANCY, SO I'M
CURIOUS WHAT NIAID IS DOING IN
THAT AREA.
>> SO YOU KNOW, IT'S AN
INTERESTING QUESTION BECAUSE THE
SPECTRUM FROM DISCOVERY TO
GETTING IT INTO PEOPLE IS A VERY
COMPLICATED AND LONG ONE.
SO WE HAVE TRADITIONALLY BEEN ON
THE DISCOVERY SIDE.
ALL OF OUR WORK BOTH IN
DISCOVERY AT THE BENCH AS WELL
AS THE CLINICAL TRIAL STUDY OF
VACCINE AND THAT'S REALLY
TRADITIONALLY WHERE WE HAVE
BEEN -- WE DO THAT WORK, THE
DATA INFORM THE RECOMMENDATIONS
THAT YOU HEAR FROM CDC, ACIP, ET
CETERA.
I THINK THE QUESTION IS, CAN
MORE BE DONE TO UNDERSTAND
WHAT'S INFORMING PEOPLE'S
RELUCTANCE TO ACTUALLY GET
VACCINES THAT HAVE BEEN SHOWN TO
BE SAFE AND EFFECTIVE IN
CLINICAL TRIALS.
AND TO ME, THAT'S A VERY VALID
RESEARCH QUESTION.
I THINK THE MORE WE CAN
UNDERSTAND ABOUT WHAT'S DRIVING
LOWER RATES OF VACCINES, THE
BETTER OFF WE ARE IN TERMS OF
HOW TRANSPARENT THE PUBLIC
DIALOGUE IS AS WELL AS
ADDRESSING WHATEVER THOSE
CONCERNS ARE.
SO WE ARE COMMITTED TO CONTINUE
THAT DIALOGUE.
AS FAR AS FUNDING THAT WORK,
AGAIN, OUR PRIORITIES HAVE
MOSTLY BEEN IN THAT EARLIER PART
OF THE SPECTRUM, AND WITH AN
UNKNOWN BUDGET ENVIRONMENT AT
THIS POINT, IT'S GOING TO BE
REALLY TOUGH TO TAKE ON OR
EXPAND TOO MUCH MORE.
BUT I HEAR YOU AND I THINK IT'S
AN INCREDIBLY IMPORTANT TOPIC
FOR US TO UNDERSTAND BETTER.
>> SESH?
>> I DON'T WANT TO TAKE AWAY
FROM THE NEXT TALK, BUT I'M
INVOLVED WITH A NETWORK THAT IS
ALSO INTERESTED IN ENGAGING
HISTORICALLY UNDERREPRESENTED
POPULATIONS IN RESEARCH.
IF YOU HAVE A EXEAND YU COMPENDT
OF IMPLEMENTATION SCIENCE TOOLS
THAT YOU HAVE FOUND WORKED IN
DIFFERENT POPULATIONS, THAT
WOULD BE A TREMENDOUS RESOURCE.
I KNOW THERE ARE MANY OUT THERE,
BUT I WOULD CERTAINLY SAY THAT
THE NIAID HAS DONE GREAT WORK IN
THIS AREA, AND THAT LIST WOULD
BE VERY MUCH APPRECIATED.
THANK YOU.
>> I REALLY APPRECIATE THAT, AND
KIND OF WADING INTO THE LONG
COVID WORLD, UNDERSTANDING HOW I
THINK ADVANCED PARTICULARLY THE
HIV TEAMS IN NIAID HAVE BEEN
WITH THAT KIND OF WORK HAVE BEEN
EYE OPENING.
SO HAPPY TO SHARE THAT, AND I'LL
GET BACK TO THE GROUP ON HOW WE
MIGHT DO THAT.
>> THANK YOU.
WE'LL TAKE THE LAST QUESTION OR
COMMENT FROM BONNIE MALDONADO.
>> HEY, JEANNE.
THANKS SO MUCH FOR ALL OF THE
WORK THAT YOU'VE DONE AND
EVERYTHING YOU'VE EXPLAINED
TODAY AND WHAT YOU'VE DONE IN
YOUR CAREER.
I DON'T KNOW IF YOU KNOW BUT I
WAS ONE OF THE ORIGINAL MEMBERS
OF THE EXECUTIVE COMMITTEE AND
SCIENTIFIC COMMITTEE FOR IMPACT,
SO WE'VE SPENT MOST OF MY CAREER
WORKING WITH PEOPLE LIKE ROHAN
AND OTHERS TO REALLY LOOK AT HIV
IN THE PLACES WHERE IT'S HIT THE
HARDEST, FIRST STARTING IN THE
U.S. AND THEN WORKING IN
SUB-SAHARAN AFER CANNED A OTHER
PLACES.
SO MY QUESTION IS HOW DO YOU
THINK WE'LL BE WORKING IN OTHER
AREAS OF GLOBAL HEALTH AND
INFECTIOUS DISEASE IMPACT ALONG
WITH, FOR EXAMPLE, FOGARTY, DO
YOU FEEL LIKE THERE WILL BE
OVERLAP THERE?
THERE ARE, AS YOU MENTIONED, HPD
FOR EXAMPLE IS STILL ONE OF THE
MOST -- ONE OF THE BIGGEST
KILLERS OF WOMEN IN SUB-SAHARAN
AFRICA AND OTHER PARTS OF THE
WORLD, AND TO WHAT EXTENT WILL
WE BE ABLE TO WORK NOT ONLY IN
THE U.S. ON THESE ISSUES BUT
ACROSS THE WORLD TO REALLY MODEL
THE REDUCTION OF THESE DEADLY
DISEASES AND EITHER CURRENT OR
EMERGING DISEASES IN THE WORLD?
THANK YOU.
>> THANK YOU FOR YOUR WORK AS
WELL, BONNIE.
I COULDN'T AGREE MORE.
MY ARGUMENT HAS ALWAYS BEEN THAT
GLOBAL HEALTH IS HUMAN HEALTH
AND VICE VERSA, AND IF WE CAN'T
REALLY CONTINUE TO DO THE WORK
THAT WE NEED TO DO GLOBALLY,
IT'S GOING TO BE JUST
DEVASTATING.
NOT JUST FOR THE PEOPLE THERE,
BUT FOR THE PEOPLE HERE, RIGHT?
FOR ALL THE REASONS THAT YOU
MENTIONED.
ABOUT 10% OF OUR BUDGET IS SPENT
GLOBALLY.
SO IT'S A SUBSTANTIAL PORTION
AND A LOT OF THAT INFORMS THE
DEVELOPMENT AND MAINTENANCE OF
SOME OF THESE NE NETWORKS JUST E
YOU MENTIONED.
THESE NETWORKS REALLY SHOWED
THEIR WORTH WHEN THEY WERE ABLE
TO BE USED ON A DIME PRETTY MUCH
DURING COVID, RIGHT?
SO WE WERE ABLE TO RAMP UP
STUDYING PARTICULARLY VACCINES
REALLY QUICKLY.
SO WE HAVE TO KEEP MAKING THE
CASE FOR THAT.
THERE'S NO QUESTION.
AND YOU CAN COUNT ON US TO KEEP
DOING THAT.
>> THANK YOU, EVERYONE, FOR YOUR
QUESTIONS.
JEANNE, THIS WAS TERRIFIC.
IS THERE ONE MORE COMMENT FROM
CYNTHIA IN THE CHAT BOX?
>> YES, SORRY.
I JUST -- IT WAS MORE OF A
COMMENT, BUT THERE IS A
DIFFERENCE IN THE WAGE STATE
SCREENS HAVING MOVED BETWEEN
STATE RECENTLY.
IT'S VERY CURIOUS AND I WONDER
IF THERE'S SOME PUBLIC HEALTH
INITIATIVE THAT WE COULD ESPOUSE
TO MAYBE --
>> I THINK CDC MIGHT HAVE JUST
UPDATED THE GUIDANCE AND I THINK
IT GOING TO BE A MATTER -- SO
THAT THERE'S MORE ROUTINE
SCREENING FREQUENTLY DURING
PREGNANCY, BECAUSE THERE USED TO
BE THAT WISHY WASHY THING DURING
THE THIRD TRIMESTER IF YOU'RE AT
RISK, WHICH DID NOT -- DOESN'T
MEAN ANYTHING.
NOT KNOWING.
SO I THINK THAT I'D HAVE TO
CHECK BUT I THINK THEY JUST
UPDATED THE GUIDANCE IN AN
ATTEMPT TO MAKE IT MORE
CONSISTENT.
IT MAY TAKE STATES A BIT TO
CATCH UP BUT YOU'RE RIGHT, THERE
SHOULDN'T BE ANY DIFFERENCE AT
ALL.
>> THANK YOU.
>> WELL, JEANNE, THIS WAS JUST
TERRIFIC.
>> THANK YOU.
>> WE'RE VERY APPRECIATIVE OF
YOUR TIME AND YOUR EXPERTISE AND
THIS IS GREAT FOUNDATION FOR OUR
SUBSEQUENT DISCUSSION.
YOU'RE WELCOME TO STAY FOR THE
NEXT SESSION, WHICH IS USUALLY
THE HIGHLIGHT OF OUR COUNCIL
MEETING.
I KNOW YOU HAVE A BUSY SCHEDULE.
BUT FOR OUR NEW MEMBERS, WE
REGULARLY FEATURE A SEGMENT
CALLED THE VOICE OF THE
PARTICIPANT.
THIS GIVES US A CHANCE TO HEAR
FROM THOSE WHO HAVE HAD PERSONAL
EXPERIENCES RELATED TO RESEARCH
THAT NICHD FUNDS.
TODAY WE ARE WELCOMING MS. APRIL
CHAVEZ, WHO WILL SPEAK ABOUT HER
EXPERIENCE AS A PATIENT WHO
SUFFERED FROM MATERNAL SEPSIS
AND HER PERSPECTIVE ON BEING A
PARTICIPANT IN A RESEARCH STUDY
THAT AIMS TO IMPROVE THE CARE
FOR PREGNANT WOMEN.
WELCOME, MS. CHAVEZ.
WE'RE SO GRATEFUL THAT YOU COULD
JOIN US.
>> WE CAN'T HEAR YOU.
>> CAN YOU HEAR ME NOW?
>> YES.
>> THAT IS NOT THE FOOT I WANTED
TO START ON, SO GLAD WE GOT THAT
ONE OUT OF THE WAY.
THANK YOU ALL SO MUCH FOR
ALLOWING ME TO BE HERE TODAY.
I AM GOING TO PULL UP MY SLIDES
REALLY QUICKLY AND THEN WE WILL
JUMP INTO -- OKAY.
CAN YOU ALL SEE THAT
PRESENTATION ON THE SCREEN NOW?
PERFECT.
OKAY.
MU NAMY NAME IS APRIL CHAVEZ, IA
MATERNAL SEPSIS SURVIVOR.
I'M REALLY EXCITED TO BE HERE
TODAY.
I'VE SHARED MY STORY IN A LOT OF
PLACES IN DIFFERENT ENVIRONMENTS
BUT BEING HERE TODAY WITH
DR. BAUER, THIS IS REALLY A FULL
CIRCLE MOMENT FOR ME SO I THINK
YOU'LL SEE WHY AS WE GO THROUGH
THINGS AND AS DR. BAUER PRESENTS
AS WELL.
AS I JUMP INTO THINGS, I JUST
WANT TO REMIND YOU THAT THERE
ARE REAL WOMEN BEHIND EACH
NUMBER AND EACH STATISTIC THAT
WE TALK ABOUT IN THESE TYPES OF
SETTINGS.
MY GOAL HERE IS TO REMIND THIS
GROUP ABOUT THE POWER THAT
MYSELF AND OTHER WOMEN MIGHT
BRING TO THE TABLE EVEN THOUGH
WE'RE NOT MEDICAL EXPERTS OR
ANYTHING OF THAT MEANS, WE DO
HAVE A VOICE AND THIS LIVED
EXPERIENCE IS REALLY IMPORTANT
WHEN IT BECOMES TO CREATING
CHANGE TO SOME OF OUR BIGGEST
MATERNAL HEALTH CHALLENGES.
SO, AFTER YEARS OF TRYING TO GET
PREGNANT, MY HUSBAND AND I
FINALLY FOUND OUT THAT WE WERE
GOING TO BE PARENTS AT THE
BEGINNING OF 2017.
WE WERE OVER THE MOON.
I HAVE A VERY TYPE A PERSONALITY
SO I THINK IT'S SAFE TO SAY THAT
I WENT STRAIGHT TO AMAZON AND
WENT A LITTLE BIT OVERBOARD WITH
ALL OF THE BABY BOOKS.
I GOT EVERY SINGLE APP ON MY
PHONE TO KNOW HOW BIG THE BABY
WAS AND WHAT SHOULD BE HAPPENING
AND I WAS JUST REALLY IN TUNE
WITH WHAT I WAS ABOUT TO
EXPERIENCE BECAUSE WE WERE TOLD
PREVIOUSLY THAT IT MIGHT NOT
EVER HAPPEN FOR US.
BUT I WAS REALLY EXCITED ON
SEPTEMBER 2ND MY SON CRUZ MADE
HIS ENTRANCE INTO THE WORLD.
HE WAS HEALTHY, I WAS HEALTHY,
EVERYTHING WAS NORMAL AND HE HAD
ALL THE NURSES SWOONING WITH HIS
FULL HEAD OF HAIR.
SO THIS WAS IT, THIS WAS ABOUT
TO BE THE START OF MY FAIRY TALE
THAT I ALWAYS WANTED.
WHAT I DIDN'T REALIZE THEN WAS
THAT MY FAIRY TALE WAS ABOUT TO
TAKE A TURN TO BASICALLY A
FULL-ON NIGHTMARE.
ON THE DAY I WAS SUPPOSED TO BE
DISCHARGED FROM THE HOSPITAL, I
STARTED TO FEEL TERRIBLE.
I FELT LIKE MY HEART WAS RACING,
I COULDN'T CATCH MY BREATH, AND
EVEN THINGS JUST LIKE STANDING
UP WERE A CHALLENGE.
I STARTED TO RUN A FEVER BUT
WHEN I SHARED ALL THESE SYMPTOMS
WITH MY MEDICAL TEAM, THERE WAS
NO REAL CONCERN OR SENSE OF
URGENCY, THEY BASICALLY KEPT
REMINDING ME THAT I JUST HAD A
BABY, IT'S NORMAL TO FEEL TIRED,
IT'S NORMAL FOR YOUR WHITE BLOOD
CELL COUNT TO INCREASE SO
BASICALLY ANY OF THE SYMPTOMS
THAT I BROUGHT UP, THEY WERE
KIND OF EXPLAINED AWAY OR
DISMISSED.
AT ONE POINT I WAS LI LITERALLY
LAYING IN THE BED JACKHAMMERING
WITH CHILLS, A DOCTOR CAME IN
AND CRANKED MY THERMOSTAT UP TO
80 DEGREES AND I WAS TOLD TO
TAKE A HOT SHOWER AND JUST TRY
TO RELAX.
WHEN MY CHILLS TURNED TO SWEATS
I WAS BROUGHT A FAN TO MY
BEDSIDE, THEY KEPT REMINDING ME
EVERYTHING WAS FINE, THIS IS
NORMAL AFTER CHILDBIRTH, IT
MIGHT JUST BE THE THERMOSTAT IN
YOUR ROOM.
WHEN I TALKED ABOUT MY RACING
HEART THEY SAID YOU'RE PROBABLY
JUST ANXIOUS ABOUT BEING A NEW
MOM.
AS SOMEBODY LIKE I SAID, NO
MEDICAL DEGREE, NO IDEA WHAT A
RACING HEART, FEVER, PAIN,
TROUBLE BREATHING, HEADACHE AND
ALL OF THESE SYMPTOMS MEANT FOR
ME, AND I HAD STRUGGLED WITH
ANXIETY ABOUT 10 YEARS PRIOR, MY
BIGGEST REGRET WAS I LET THEM
CONVINCE ME THIS WAS ALL NORMAL.
ALL NEW MOMS FEEL THIS WAY AND
MAYBE JUST CHILDBIRTH WAS HARDER
THAN I THOUGHT.
THEY WERE THE EXPERTS AND
REGARDLESS OF HOW MANY TIMES I
SHARED MY SYMPTOMS OR CONCERNS,
THEY SAID THAT EVERYTHING WAS
NORMAL, SO I THOUGHT SURELY IT
IS.
SOMETHING I'LL NEVER FORGET IS
THERE WAS A DOCTOR IN THE MIDDLE
OF THE NIGHT WHO I WAS TALKING
TO HIM ABOUT HOW I WAS FEELING
AND HE SAID YOU'RE BEING CRAZY
AND YOU NEED TO STOP.
SO AT THAT POINT, I LET THEM
SEND ME HOME.
THEY SAID YOU'LL FEEL BETTER
ONCE YOU GET HOME, WE'RE GOING
TO GIVE YOU SOME ANXIETY MEDS,
JUST GO HOME AND RELAX AND
YOU'LL FEEL BETTER.
SO I WENT HOME WITH MY SON AND
MY HUSBAND, BUT THINGS REALLY
STARTED TO GET WORSE.
I COULDN'T EAT, I COULDN'T
SLEEP, I COULDN'T GO TO THE
BATHROOM, I COULDN'T CARE FOR
MYSELF MUCH LESS A NEWBORN BABY
AT THAT POINT.
SO I STARTED TO KEEP A LIST AND
THIS SCREENSHOT THAT YOU'LL SEE
ON THE LEFT-HAND SIDE, THAT'S
ACTUAL NOTES FROM MY PHONE OF
JUST KIND OF EVERYTHING I WAS
FEELING AT THAT TIME JUST
BECAUSE THERE WAS SO MUCH GOING
ON WITH MY BODY THAT I COULDN'T
EVEN KEEP THINGS STRAIGHT AT
THAT POINT.
SO I STARTED TO MAKE A LIST
KNOWING THAT THE NEXT TIME I GOT
BACK OR WAS ABLE TO CALL A
HEALTHCARE PROVIDER, I WOULD
TALK ABOUT ALL THESE THINGS.
THESE THINGS WERE ALL THINGS
THAT IN ONE WAY OR ANOTHER I HAD
ALREADY EXPRESSED BUT I REALLY
JUST WANTED TO KEEP A LIST OF
THINGS THAT WERE STRAIGHT.
SO THAT'S MY LIST ON THE LEFT OF
THE SCREEN SHOTS OF WHAT I NOTED
AND THE SIGNS ON THE RIGHT ARE
ACTUALLY THE WARNING SIGNS, PART
OF AN INITIATIVE THAT I WAS PART
OF WITH DR. BAUER WHO YOU'LL
HEAR FROM SHORTLY.
SO I WANTED TO REALLY QUICKLY
SHOW YOU THE POWER IN A TOOL
LIKE THIS.
AT MY HOSPITAL, THERE WAS NO
SIGNAGE THAT TALKED ABOUT SEPSIS
OR URGENT MATERNAL WARNING
SIGNS.
BUT I WISH THERE HAD BEEN.
ALL OF THESE THINGS CIRCLED WERE
THINGS THAT I SPECIFICALLY HAD
MENTIONED TO MY MEDICAL TEAM
BEFORE I WAS EVER DISCHARGED.
AND AS YOU CAN SEE, IF A TOOL
LIKE THIS HAD BEEN IN MY ROOM OR
IN THE HOSPITAL SOMEWHERE OR
GIVEN TO ME, I WOULD HAVE BEEN
ABLE TO SAY LOOK HOW MANY OF
THESE I HAVE.
YOU ARE NOT SENDING ME HOME.
SOMETHING IS WRONG.
BUT AT THAT POINT, I DIDN'T HAVE
THE TOOLS OR THE KNOWLEDGE TO
REALLY GO AGAINST WHAT THEY WERE
SAYING.
I HAD TO TRUST THAT THEY WERE
THE EXPERTS, EVERYTHING WAS
FINE.
SO THIS IS ONE OF THE TOOLS THAT
I KNOW IS GOING TO MAKE THINGS
BETTER FOR OTHER WOMEN AS WELL.
WHEN I WAS AT HOME -- SORRY, I
GOT A LITTLE OUT OF ORDER THERE,
BUT WHEN I WAS HOME, I WASN'T
FEELING BETTER SO I KEPT THAT
LIST AND EVENTUALLY MY MOM
INSISTED THAT SOMETHING WAS
WRONG AND SHE SAID WE NEED TO GO
BACK.
I JUST KEPT THINKING ABOUT HOW
NOT WORRIED MY TEAM OF EXPERT
WERE BEFORE.
THE DOCTOR TELLING ME I WAS
CRAZY AND I REALLY WAS JUST
HESITANT TO GO BACK BECAUSE THEY
ALREADY TOLD ME I WAS FINE, I
DIDN'T WANT TO -- I DIDN'T WANT
TO UPSET THEM IN A LOT OF WAYS
BECAUSE AT THAT POINT, THEY HAD
MADE ME FEEL LIKE A BURDEN, NOT
LIKE A PATIENT WHO WAS TREATED
WITH RESPECT AND EMPATHY.
SO MY MOM INSISTED THAT I GO
BACK.
WHEN I WAS TOOK BACK TO THE
HOSPITAL, I WAS BASICALLY PUT IN
TRIAGE AND LEFT TO SIT.
THERE WAS STILL NO URGENCY, NO
QUESTIONS, NO CONCERNS.
SO I LAID IN THAT BED IN TRIAGE
ALL DAY AND I GREW SICKER AND
SICKER.
MY MOM AT ONE POINT BROUGHT UP
TO THE NURSE THAT MY BLOOD
PRESSURE WAS PLUMMETING AND SHE
WAS TOLD THAT THERE WAS NO
REASON FOR CONCERN, AND THAT'S
WHAT MY BLOOD PRESSURE WAS WHEN
I HAD DELIVERED MY BABY.
AND IT WAS PROBABLY JUST MY
NORMAL, SO AGAIN, MY WHOLE TEAM
JUST CONTINUED TO SAY THAT
EVERYTHING WAS FINE.
IT WASN'T UNTIL THEY COULDN'T
FIND MY VEINS AND THEY HAD TO
CALL A RAPID RESPONSE NURSE THAT
FINALLY SOMEBODY REALIZED THAT
SOMETHING WAS WRONG.
THE NURSE TOOK ONE LOOK AT MY
CHART AND HE KNEW THAT SOMETHING
WAS WRONG AND HE ASKED WHY I
HADN'T BEEN SENT UP TO THE ICU.
ACTUALLY INSTEAD OF WAITING FOR
THE TRANSPORT TEAM HE TOOK ME UP
TO THE ICU HIMSELF WHICH OF
COURSE GROAK BROAK HOSPITAL
PROTOCOL AND I LEARNED HE WAS
WRILT ENUP FOR HIS ACTIONS BUT
THERE WAS NO DOUBT IN MY MIND
THAT WITHOUT HIM I PROBABLY
WOULD HAVE DIED IN TRIAGE
BECAUSE THERE WAS NO UR URGENCY,
NOBODY WAS TAKING ME SERIOUSLY
AND IF IT WASN'T FOR HIM, I
WOULD HAVE BEEN JUST THE ANXIOUS
NEW MOM WHO WAS OVERREACTING AND
I KNOW I WOULD HAVE DIED THERE
BECAUSE NOBODY LISTENED.
WHEN I WAS TAKEN UP TO THE ICU,
THAT'S WHERE MY FAMILY WAS TOLD
I WAS IN SEPTIC SHOCK.
I WAS PLACED ON A VEN L VENTILA,
DIALYSIS AND EVENTUALLY THEY
TOLD MY FAMILY TO CALL THOSE
THAT WERE CLOSEST TO ME TO SAY
GOODBYE BECAUSE I HAVE PROBABLY
WASN'T GOING TO MAKE IT.
ALL DURING THIS TIME, MY SON WAS
AT HOME WITH FAMILY CARING FOR
HIM BUT I CAN'T HELP THINK THIS
ISN'T HOW IT'S SUPPOSED TO BE.
I WAS FIGHTING FOR MY LIFE AND I
WAS IN A FULL-ON MIGHT MAYOR AT
THAT POINT.
BUT MY FAMILY REFUSED TO GIVE UP
ON ME AND ALL OF THE ODDS WERE
STACKED AGAINST ME, I SURVIVED.
I TRULY DO BELIEVE THAT PART OF
THE REASON THAT I SURVIVED IS TO
SHARE MY STORY AND DO WHATEVER I
CAN TO MAKE SURE THAT NO OTHER
WOMAN IS TREATED THE WAY THAT I
WAS.
I MISSED THE ENTIRE FIRST MONTH
OF MY SON'S LIFE.
I HAD TO LEARN HOW TO WALK
AGAIN.
MY MOTHER HAD TO HELP ME SHOWER
EVEN AFTER I WAS RELEASED FROM
THE HOSPITAL WHICH WAS ABOUT A
LITTLE OVER A MONTH AFTER I HAD
MY SON.
I COULDN'T CARE FOR MYSELF, I
COULDN'T CARE FOR MY SON.
I HAD TO RELY ON OTHERS TO DO
ALL OF THAT.
I'M REALLY THANKFUL TO HAVE
SURVIVED BUT AS YOU'LL HEAR FROM
DR. BAUER SHORTLY AND AS I'M
SURE YOU ALREADY KNOW MATERNAL
SEPSIS DEATHS ARE OFTEN
PREVENTABLE WITH EARLY DIAGNOSIS
AND TREATMENT.
I CONSTANTLY WONDER WHAT MY
JOURNEY WOULD HAVE BEEN LIKE IF
SOMEONE WOULD HAVE JUST LISTENED
TO ME INSTEAD OF BRUSHING ME OFF
AND BRANDING ME AS THE ANXIOUS
CRAZY LADY.
THIS IS SOME PHOTOS OF WHEN MY
SON WAS FINALLY ABLE TO COME IN
AND KIND OF RECONNECT WITH ME IN
THE HOSPITAL, BUT I WAS COVERED
IN WIRES AND GOWNS AND I JUST
REMEMBER CRYING BECAUSE THIS
ISN'T THE WAY THAT IT WAS
SUPPOSED TO BE.
I COULDN'T EVEN STAND UP ON MY
OWN.
YOU'LL NOTICE THAT I'M NOT
REALLY HOLDING HIM BECAUSE MY
HANDS HAD BASICALLY -- ALL THE
SKIN HAD PEELED SO I COULDN'T
EVEN HOLD HIM.
AND IT WAS JUST -- IT WAS A
REALLY EMOTIONAL, HARD TIME,
WHICH OBVIOUSLY I WAS THANKFUL
TO BE ALIVE, BUT KNOWING THAT
THAT WHOLE MONTH LONG PLUS
JOURNEY IN THE HOSPITAL COULD
HAVE BEEN PREVENTED BY PEOPLE
LISTENING TO ME IS SOMETHING
THAT I WANT TO MAKE SURE DOESN'T
HAPPEN TO ANYBODY ELSE AND AGAIN
THAT'S PART OF THE REASON I
SHARE MY STORY.
I'VE ACTUALLY FOUND A LOT OF
HEALING IN ADVOCACY WORK THAT
I'VE BEEN DOING THE LAST SIX
YEARS OR SO.
I'VE GOTTEN INVOLVED WITH MAMA'S
VOICES AND SEPSIS AND LOTS OF
OPPORTUNITIES, THANKFUL FOR
DR. BAUER, WHO ALWAYS PASSES
THINGS ALONG AND DR. MAINE, BUT
IT'S KIND OF FUELED THIS FIRE IN
ME TO PUSH OUR MEDICAL SYSTEMS
TO DO BETTER.
I MENTIONED EARLIER THAT I'M AT
THE POINT WHERE THINGS ARE
REALLY COMING FULL CIRCLE BUT
BEING ABLE TO CONTRIBUTE TO
THINGS LIKE THE URGENT MATERNAL
WARNING SIGNS -- BEING PART OF
THE PROJECT, IT MAKES MY STORY
AND MY JOURNEY JUST A LITTLE BIT
EASIER TO SWALLOW SOME DAYS
KNOWING THAT THE WORK THAT I'VE
BEEN GIVEN AN OPPORTUNITY TO DO
IS GOING TO CHANGE OUTCOMES FOR
OTHER WOMEN.
WHAT VAL YOU DPO VALUE DO YOU H?
YOU'RE NOT A DOCTOR OR YOU
DON'T, YOU MIGHT NOT UNDERSTAND
THINGS.
I OFTEN FELT THAT WAY WHEN I WAS
TRYING TO GET INVOLVED IN THESE
THINGS LIKE I FELT OVERWHELMED
LIKE I DON'T KNOW IF I REQUEST
SICAN SITIN A ROOM AND TALK ABOL
THESE THINGS BECAUSE I DON'T
HAVE THAT SORT OF EXPERIENCE BUT
THERE'S SO MUCH VALUE.
I'VE BEEN FORTUNATE TO BE ABLE
TO SPEAK UP WHEN WE'RE TALKING
ABOUT THINGS LIKE -- BEING
INVAIPTED TO DO THAT AND SAY
HEY, IT MIGHT NOT BE A GOOD IDEA
FOR EVERYONE TO BE INVITED
BECAUSE YOU DON'T KNOW WHAT THE
PATIENT'S EXPERIENCE WAS LIKE
WITH THAT PARTICULAR INDIVIDUAL.
WHY DON'T WE ASK THE PATIENT OR
HOW ABOUT WE THINK ABOUT THESE
THINGS OR EVEN HOW WE
COMMUNICATE THESE THINGS TO
WOMEN, HOW WE EMPOWER THEM WITH
LANGUAGE IF THEY'RE NOT BEING
LISTENED TO LIKE I WAS.
I THINK IT'S JUST AN INCREDIBLE
EXPERIENCE TO BE ABLE TO BE A
PART OF THESE CIRCLES AND KNOW
THAT WHAT I WENT THROUGH ISN'T
FOR NOTHING.
THAT THERE ARE OTHER PEOPLE THAT
ARE WORKING TO CREATE CHANGE AND
I'VE BEEN INVITED INTO THOSE
SPACES TO HELP DO THE SAME.
SO THAT'S KIND OF WHERE I THINK
I WILL END THINGS AND PASS IT
OFF TO DR. BAUER TODAY.
SO THANK YOU ALL SO MUCH FOR
GIVING ME AN OPPORTUNITY TO
SHARE NOT ONLY MY STORY BUT HOW
ADVOCACY WORK AND BEING INVOLVED
IN SOME OF THESE THINGS HAS
REALLY CHANGED THE TRAJECTORY
ABOUT HOW I THINK ABOUT MY STORY
AND HOW I KIND OF MOVE FORWARD
FROM HERE.
>> THANK YOU, APRIL, FOR WILLING
TO BE SO PUBLIC, TRULY PUBLIC
WITH YOUR STORY AND THERE ARE
COMMENTS IN THE CHAT BOX.
I JUST HAD A QUESTION, IS RORY
YOUR SON BECAUSE ON THE FIRST
SLIDE, IT ACKNOWLEDGED SOMEONE
NAMED RORY STANTON.
IS THAT YOUR SON?
>> NO, ACTUALLY MY SON'S NAME
IS CRUZ.
RORY STANTON IS -- ONE OF THE
FIRST ORGANIZATIONS I GOT
INVOLVED IN WAS END SEPSIS, THE
LEGACY OF RORY STANTON, AND HE
DIED FROM SEPSIS WHEN HE WAS 10
YEARS OLD FROM A SCRATCH IN GYM
CLASS, AND I MET HIS MOM AND
REALLY I NEVER WANTED TO TALK
ABOUT MY STORY BEFORE I BECAUSE
I FELT IT WAS REALLY PERSONAL
AND I WOULD CRY ALL THE TIME
THINKING ABOUT IT.
BUT AFTER I GOT TO MEET RORY'
MOM, I REALIZED THAT IF I DIDN'T
SPEAK UP, IT WOULD CONTINUE TO
HAPPEN AND I HAD POWER TO CREATE
REAL CHANGE.
SO RORY IS SOMEBODY WHO'S REALLY
IMPORTANT TO ME AND HAS INSPIRED
ME TO DO A LOT OF THE WORK.
>> THANK YOU FOR EXPLAINING
THAT.
>> OF COURSE.
>> SO AGAIN, WE REALLY TREASURE
THESE PERSONAL STORIES WHICH
PROVIDE CONTEXT AND MEANING TO
THE RESEARCH THAT YOU'RE GOING
TO HEAR ABOUT FROM DR. BAUER.
I ALSO WANT TO MENTION, APRIL,
THAT THIS PART OF OUR COUNCIL
MEETING IS LISTENED TO BY ALL OF
OUR STAFF AND IT INFLUENCES
PEOPLE WHO, FOR EXAMPLE, HAVE
ADMINISTRATIVE JOBS WHO NEVER
REALLY DIRECTLY INTERACT WITH
THE PEOPLE IMPACTED BY OUR
RESEARCH.
SO YOU'RE ALSO AFFECTING THEM AS
WELL.
SO THANK YOU.
AND LET ME NOW INTRODUCE
DR. MELISSA BAUER FOR A
SCIENTIFIC PRESENTATION ABOUT
HER WORK THAT'S ALREADY BEEN
ACKNOWLEDGED ON THE EARLY
IDENTIFICATION AND TREATMENT OF
MATERNAL SEPSIS.
DR. BAUER IS DUAL CERTIFIED IN
CRITICAL CARE AND
ANESTHESIOLOGY.
SHE RECEIVED HER D.O. DEGREE
FROM MICHIGAN STATE AND
COMPLETED HER RESIDENCY IN
ANESTHESIOLOGY AT THE UNIVERSITY
OF MICHIGAN ANN ARBOR FOLLOWED
BY FELLOWSHIP STUDIES IN
OBSTETRIC ANESTHESIA AT THE
UNIVERSITY OF MICHIGAN AND IN
CRITICAL CARE ANESTHESIA AT
COLUMBIA UNIVERSITY.
AMONG HER MANY ACHIEVEMENTS, DRR
FOR THE CALIFORNIA MATERNAL
QUALITY CARE COLLABORATIVE
PATERNAL SEPSIS TOOLKIT WHICH
PROVIDES STEP BY STEP
INSTRUCTIONS FOR HOSPITALS ON
HOW TO IMPLEMENT SCREENING AND
TREATMENT FOR MATERNAL SEPSIS.
HER TALK TODAY IS TITLED
IMPROVING MATERNAL SEPSIS CARE
TO PATIENT AND COMMUNITY.
>> THANK YOU FOR THE HONOR TO
SPEAK HERE TODAY AND TO APRIL
FOR SHARING YOUR STORY.
SHE'S BEEN A REALLY INTEGRAL
PART OF OUR TEAM AND I'M REALLY
EXCITED TO SHARE WITH YOU WHAT
WE'VE BEEN DOING.
SO LET ME GO AHEAD AND PULL UP
MY SLIDES.
THIS WORK IS IN COMPLEMENT WITH
ELLIOTT MAINE, MULTIPLE PI AND
I'M THE COP TACT PI OF THIS
PROJECT.
WE'VE BEEN WORKING TOGETHER
EVERY STEP OF THE WAY.
SO LET'S GO AHEAD AND GET
STARTED.
I'D LIKE TO ACKNOWLEDGE THE
FUNDING THAT MADE THIS WORK
POSSIBLE.
SO MATERNAL SEPSIS IS THE
LEADING CAUSE OF MATERNAL
MORTALITY FROM THE MOST RECENT
REPORT FROM THE CDC THAT
INCLUDED THE COVID PANDEMIC.
IT IS THE THRD LEADING CAUSE OF
SEVERE MATERNAL MORBIDITY AT THE
TIME OF DELIVERY BUT IT IS THE
FIRST LEADING CAUSE IN THE
ANTEPARTUM AND POSTPARTUM
PERIODS.
THERE ARE SIGNIFICANT RACIAL
INEQUITIES IN THOSE WHO
EXPERIENCE SEPSIS.
THESE STEPS ARE LARGELY
PREVENTABLE.
THREE STATE MATERNAL MORTALITY
COMMITTEES REVIEWED THEIR DEATHS
AND FOUND THESE DEATHS WOULD
HAVE BEEN PREVENTABLE AT LEAST
40% OF THE TIME WITH APPROPRIATE
CARE.
THERE ARE A NUMBER OF RESOURCES
AVAILABLE TO PROVIDE GUIDANCE
FOR CARE PRACTICES WITHIN THE
HOSPITAL SETTING.
BUT WE KNOW THAT PATIENTS DON'T
LIVE THEIR LIVES IN A HOSPITAL
AND SO WE WANTED TO SEE HOW WE
COULD MAKE THE MOST IMPACT IN
REDUCING MATERNAL SEPSIS DEATHS
AS WELL AS SEVERE MATERNAL
MORBIDITY FROM IT BECAUSE WE
KNOW THAT THE TIME IN THE
HOSPITAL THAT ALL THE RESOURCES
ARE FOCUSED ON ARE DURING THAT
THREE TO FOUR DAYS IF EVERYTHING
GOES WELL DURING THAT TIME IN
THE HOSPITAL, BUT IF A PATIENT
IS CARRIED TO TERM, IT COULD BE
280 DAYS AND THEN ALSO THEY
WOULD BE POSTPARTUM 365 DAYS.
SO IF WE ONLY FOCUS ON THOSE
THREE TO FOUR DAYS, WE'LL MISS A
LOT OF OPPORTUNITIES TO MAKE AN
IMPACT.
BECAUSE PATIENTS AS WE SAID
DON'T LIVE THEIR LIVES IN A
HOSPITAL.
SO WHAT WE WANTED TO DO WAS
LEVERAGE USING COMMUNITY
ENGAGEMENT TO WORK SIDE BY SIDE
WITH OUR PARTNERS AS YOU SEE AS
YOU MET APRIL ALREADY TO
IDENTIFY BARRIERS AND STRATEGIES
TO ADDRESS THEM AND HELP
DISSEMINATE THESE FINDINGS
WITHIN COMMUNITIES.
AND THERE'S MANY DIFFERENT
LEVELS OF COMMUNITY ENGAGEMENT
AND WE CHOSE TO WORK AT THE
HIGHEST LEVEL OF SHARED
LEADERSHIP AND THAT WE WORKED TO
SHARE POWER, WE ALSO CREATED
VERBAL AGREEMENT ON HOW WE WOULD
WORK TOGETHER, AND ALSO JUST
REALLY WORKING TOGETHER BECAUSE
WE WANTED TO WORK IN -- MAKE
SURE WE WERE ADDRESSING
EVERYTHING AND REALLY HEARING
THE PATIENT'S VOICE WITHIN OUR
WORK.
SO ONE OF THE FIRST THINGS THAT
WE DID WITH THIS FUNDING WAS WE
RECRUITED AND CREATED THE
COMMUNITY -- THE SEPSIS
COMMUNITY LEADERSHIP BOARD, AND
KENDRA SMITH IS OUR COMMUNITY
ENGAGEMENT LIAISON.
SHE'S AN INCREDIBLE EXPERT IN
THAT FIELD AND WE WANTED TO MAKE
SURE THAT WE WERE DOING
EVERYTHING RIGHT AS FAR AS
LISTENING AND INCORPORATING AND
SUGGESTIONS AND THEY CREATED A
STANDARD OPERATING PROCEDURES
AND THEY ALSO -- THEIR PURPOSE
WAS TO ENGAGE IN RESEARCH
ACTIVITY DESIGNED TO UNDERSTAND
OR REDUCE MATERNAL MORBIDITY AND
MORTALITY FOR MATERNAL SEPSIS
WHILE LEVERAGING COMMUNITY
EXPERIENCES AND VOICES.
AND OUR MEMBERSHIP WAS COMPOSED
OF MATERNAL SEPSIS SURVIVORS,
HEALTH EQUITY ADVOCATES, PUBLIC
HEALTH EXPERTS, AND COMMUNITY
LEADERS THAT WERE REALLY
INTERESTED IN IMPROVING MATERNAL
HEALTH WITHIN THEIR COMMUNITIES
AND WE HAD REPRESENTATIVES FROM
URBAN, RURAL AND TRIBAL
COMMUNITIES.
THE ULTIMATE GOAL OF THIS
PROJECT WAS TO DO OUR HOSPITAL
IMPLEMENTATION AND THIS WAS DONE
IN 66 -- ALL 66 BIRTHING
HOSPITALS IN THE STATE OF
MICHIGAN AND ALSO 60 HOSPITALS
IN CALIFORNIA THAT WAS LED BY
ELLIOTT MAINE AND WE USED
MENTORSHIP TEAMS AS THEY WERE
IMPLEMENTING THESE PRACTICES
THAT WE RECOMMENDED THROUGHOUT
THEIR HOSPITALS AND WE MET
MONTHLY TO WORK TOGETHER AND
GIVE THEM SOME COPING ON HOW TOW
TO DO THIS IN THE BEST WAY.
NORMALLY IN CALIFORNIA, THEY'VE
DONE SOME GREAT WORK IN REDUCING
THEIR MATERNAL MORBIDITY AND
MORTALITY BY HAVING THESE
MENTORSHIP TEAMS BE DOCTORS AND
NURSES THAT WOULD MEET WITH
HOSPITALS AND WE WANTED TO GO A
STEP FURTHER IN THAT WE ALSO
INCLUDED COMMUNITY LEADERS AND
CONSULTANTS WITH LIVED
EXPERIENCE, OUR PATIENTS,
SURVIVORS, TO ALSO BE A PART OF
THIS TEAM AND MEET WITH
HOSPITALS AND GIVE THEM FEEDBACK
ABOUT DIFFERENT THINGS THAT THEY
WANTED TO TRY AND GIVING THAT
PATIENT AND COMMUNITY
PERSPECTIVE AS WELL.
BUT BEFORE WE GOT THERE, I WANT
TO SHARE WITH YOU ALL OF THE
PROCESS AND EVERYTHING THAT WE
DID WITH THE COMMUNITY BOARD TO
MAKE THIS POSSIBLE.
SO WE KNOW THAT MATERNAL DEATHS
ARE DUE TO THREE KEY DEADLY
DELAYS FOR SEPSIS AND WE FOUND
THIS A NUMBER OF YEARS AGO IN
OUR WORK, AND CALIFORNIA
CONFIRMED IT WHEN THEY DID A
STUDY A NUMB NUMBER OF YEARS LR
BUT THESE DELAYS ARE DUE TO
DELAYS IN RECOGNITION, DELAYS IN
TREATMENT AND DELAYS IN
ESCALATION OF CARE.
SO THE REST OF THIS TALK IS
GOING TO GO THROUGH HOW WE WENT
TO COMBAT EACH ONE OF THOSE
DELAYS WITH THIS WORK AND MOST
OF THIS TALK AS YOU'LL SEE WILL
GO THROUGH RECOGNITION BECAUSE
IF YOU DON'T HAVE RECOGNITION,
YOU CAN'T HAVE TREATMENT OR
ESCALATION OF CARE.
SO LET'S GO THROUGH THIS HERE.
SO RECOGNITION, WHY IS MATERNAL
SEPSIS DIFFERENT?
WE KNOW IT'S REALLY CHALLENGING
BECAUSE A NUMBER OF THE SIGNS
THAT PEOPLE START TO LOOK FOR IN
THE DEVELOPMENT OF SEPSIS ARE
VERY SIMILAR TO THE SIGNS THAT
PREGNANT PATIENTS EXPERIENCE
GOING THROUGH CHANGES WITH
MATERNAL PHYSIOLOGICAL CHANGES
OF PREGNANCY.
THE CHALLENGE WITH THAT IS THAT
THEY DON'T STAND OUT BECAUSE IF
YOU DON'T KNOW THAT PERSON, IF
THAT PERSON IS JUST COMING IN TO
THE HOSPITAL, YOU DON'T KNOW
WHERE THEIR BASELINES ARE, MANY
PEOPLE WILL EVALUATE THAT
PATIENT AND IT MIGHT BE
CHALLENGING BECAUSE THEY ALREADY
DO HAVE THIS INCREASE IN HEART
RATE JUST BEING PREGNANT AND IT
MAKES IT REALLY CHALLENGING FOR
THESE PATIENTS TO STAND OUT
UNTIL MUCH LATER.
SO WE WANTED TO WORK ON THAT BY
PULLING SOME DATA FROM HOSPITALS
AND THIS GRANT THAT FUNDED THIS
WORK THAT WE WORKED WITH A NUMB
NUMBER OF INSTITUTIONS ACROSS
THE COUNTRY, 12 DIFFERENT SITES,
71 HOSPITALS IN 12 STATES AND WE
PULLED THEIR EHR DATA TO HAVE
THEIR VITAL SIGNS AS WELL AS
THEIR ICD CODES, DEMOGRAPHICS
AND ALL SORTS OF BITS OF
INFORMATION SO THAT WE COULD SEE
WHAT WOULD BE MAYBE THE BEST
SCREENING TOOL TO USE, SO GOING
THROUGH THIS HERE, WE HAD A
COHORT OF THE DELIVERY COHORT,
WE ALSO HAD A COHORT LOOKING AT
ANTEPARTUM ADMISSIONS AS WELL AS
POST PPOSTPARTUM ADMISSIONS.
WE HAD ABOUT 2900 CASES OF
MATERNAL SEPSIS THAT WERE
IDENTIFIED BY USING THE SEVERE
MATERNAL MORBIDITY CODES FOR
SEPSIS.
SO WITHIN THIS GROUP, LOOKING AT
THE DELIVERY HOSPITALIZATIONS,
THERE WERE ONLY 59 OF THOSE 71
HOSPITALS THAT HAD A LABOR AND
DELIVERY WARD, SO WE HAVE THAT
DATA FOR DELIVERY HOSPITALS, AND
IT COVERED A NUMBER OF REGIONS.
YOU'LL SEE IT WAS ALL OVER THE
COUNTRY.
WE HAD VARIATION IN DELIVERY
VOLUME, WE HAD SOME HOSPITALS
DELIVERING LESS THAN 50 A YEAR,
ALL THE WAY UP INTO SEVERAL OVER
10,000.
WE ALSO HAD VARIATION IN
TEACHING STATUS, ABOUT 80% WERE
NON-TEACHING HOSPITALS AND THEN
WE HAD PLACES IN RURAL
COMMUNITIES AS WELL AS VERY
POPULATED AREAS THAT SUBMITTED
DATA.
SO GOING THROUGH THE DELIVERY
HOSPITALIZATIONS, WE SEPARATED
THIS INTO TWO COHORTS AND WE
NEEDED TO LOOK AT
CHORIOAMNIONITIS A LITTLE
DIFFERENTLY BUT STARTING WITH
THE FIRST COHORT, THIS EXCLUDED
CHORIOAMNIONITIS AND -- THE
REASON FOR THAT IS THERE HAS
BEEN SOME CRITICISM OF USING
SOME SCREENING SYSTEMS TO
IDENTIFY SEVERE MORBIDITY
WHETHER THAT'S SEPSIS OR OTHER
CASES BECAUSE THERE'S A HIGH
AMOUNT OF FALSE POSITIVES SO WE
WANTED TO SAY WELL, IF
PATIENTS -- THESE ARE JUST
PATIENTS THAT HAVE NORMAL
MATERNAL PHYSIOLOGICAL CHANGES
OF PREGNANCY, WOULD THIS BE
HELPFUL IN IDENTIFYING THE
DIFFERENCE BETWEEN SOMEONE WHO'S
STARTING -- WHO'S HAVING SEPSIS
AND SOMEONE WHO JUST HAS THOSE
CHANGES OF PREGNANCY.
SO WE MATCHED THEM IN A CASE
CONTROL FASHION, WE CHOSE TO USE
THAT, WE WERE RECEIVING AN
ENORMOUS AMOUNT OF DATA FROM
EACH PATIENT TO MAKE DATA
TRANSFER A LITTLE EASIER, WE DID
THIS COMPARISON GROUP AND THEN
WE LOOKED AT ICD CODES FOR
SEPSIS BUT WE ALSO WENT A STEP
FURTHER AND LOOKED AT END ORGAN
INJURY CODES.
NOW I KNOW THAT SEPSIS DOES
INCLUDE -- REQUIRES END ORGAN
INJURY, HOWEVER, THERE ARE SOME
CHALLENGES WITH CODING IN THAT
WHEN WE STARTED LOOKING AT THE
EHR DATA, THERE WERE SOME
PATIENTS THAT PROBABLY DIDN'T
REALLY MEET THE CRITERIA FOR
HAVING SEPSIS BASED ON THAT
DEFINITION.
AND WE WANTED TO MAKE SURE THAT
WE WERE CAPTURING THE SICKEST
PATIENTS AND SO WE USE SOME
CODES THAT HAVE BEEN USED IN
OTHER ADMINISTRATIVE DATABASES
SUCH AS USING THE ANGUS AND
DEMROMO VSKI CRITERIA TO
IDENTIFY THOSE PATIENTS.
AND THEN WE LOOKED AT
CHORIOAMNIONIGHTS AND ENDOME
TTRIOITIS, THEY WERE ALREADY
INFECTED AND THEY ALSO HAD
PHYSICIAN LODGE CHANGES OF
PREGNANCY SO THAT'S A SEPARATE
GROUP TO TAKE A LOOK AND TRY TO
FIGURE OUT OF THOSE PATIENTS HOW
MANY OF THEM WOULD PROGRESS TO
SEPSIS, WHAT WOULD BE THE BEST
SCREENING TOOL TO HELP IDENTIFY
THAT.
AND SO WE LOOKED AT PATIENTS WHO
HAD CHORIO WITHOUT SEPSIS AND
THEN PATIENTS WITH SEPSIS AND
ADDITIONAL END ORGAN INJURY
CODES.
SO WE LOOKED AT A NUMBER OF
SCREENING SYSTEMS.
ONE OF THE SCREENING SYSTEMS WAS
LOOKING ADD SIRS WHICH IS WHAT
USED TO DEFINE SEPSIS IN
NON-PREGNANT ADULTS SO WE LOOKED
AT THAT CRITERIA.
WE ALSO LOOKED AT SOME PREGNANCY
SCREENS FOR SEVERE RETURN OF
MORBIDITY, MATERNAL EARLY
WARNING CRITERIA AND THE
MATERNAL EARLY WARNING TRIGGER
TOOL TO SEE HOW THOSE WOULD WORK
BECAUSE THERE ARE A NUMBER OF
TOOLS THAT ARE AVAILABLE THAT
PEOPLE MAY WANT TO TRY AND WE
WANTED TO SEE EXACTLY IN THIS
POPULATION WHAT WOULD YOU EXPECT
THE SCREEN POSITIVE RATE TO BE
AS WELL AS HOW WELL WOULD IT
WORK.
AND THEN WE ALSO USED SOME
PREGNANCY ADJUSTED SCREENS FOR
SEPSIS SPECIFICALLY.
THE CMQ CC, THE CALIFORNIA
MATERNAL QUALITY CARE
COLLABORATIVE TOOLKIT SCREENING
SYSTEM AS WELL AS UKOSS WHICH IS
USED IN THE UNITED KINGDOM.
AND OUR GOAL WAS TO FIND THE PAL
ABALANCE BETWEEN SENSITIVITY AND
SCREEN POSITIVE RATE BECAUSE
EVEN IF YOU HAVE A SENSITIVITY
OF 99%, IF YOU HAVE A SCREEN --
A FALSE POSITIVE RATE OF 40%,
IT'S REALLY NOT GOING TO BE A
USEFUL TOOL TO BE IMPLEMENTING
BECAUSE WHEN YOU USE A NUMBER OF
RESOURCES AWAY FROM THE PATIENTS
THAT NEED IT.
SO HERE ARE SOME OF THE RESULTS.
THIS WAS COHORT ONE WITHOUT ANY
OF THE PATIENTS WITH
CHORIOAMNIONITIS -- THE
SENSITIVITY FOR MOST OF THE
TOOLS WAS QUITE GOOD IN THAT IT
WAS GREATER THAN 90%.
BUT I WANTED TO FOCUS A LITTLE
BIT ON THIS SCREEN POSITIVE RATE
SO THIS WAS HOW MANY PATIENTS
SCREEN POSITIVE AND THE CMQCC
TOOL WAS 6.9%, UKOSS WAS 9.6 BUT
THE OTHER TOOLS WERE ABOUT 15%
GOING UP EVEN HIGHER THAN THAT
WHICH MAKES IT REALLY
CHALLENGING TO USE THESE TOOLS
UNLESS YOU COME UP WITH EXACTLY
WHAT THE SECOND STEP WOULD BE.
AND THE PLAN FOR THIS IS THAT
THIS IS SCREENING AND THEN THE
DIAGNOSTIC BEDSIDE EVALUATION
AND SOME LABS WOULD BE SENT OFF
AFTER THAT.
SO WE WANTED TO FIGURE OUT WHAT
WOULD BE THE BEST TOOL AND WHAT
PEOPLE COULD USE AND WHATEVER
THEY'RE COMFORTABLE WITH, WHAT
THEY SHOULD EXPECT TO SEE AS FAR
AS FALSE POSITIVES.
NOW LOOKING AT THE PATIENTS WITH
CHORIOAMNIONITIS AND ENDO
METRITIS YOU SEE THEY CERTAINLY
WOULD EXPERIENCE THOSE SIGNS OF
INFECTION AND YOU WOULD BE ABLE
TO IDENTIFY THEM EARLY AND
ALTHOUGH THE SCREEN POSITIVE
RATE WAS REALLY HIGH IN THAT AT
LEAST 45% OF THE PATIENTS WOULD
BE POSITIVE, I THINK THAT IT'S
NOT A GOOD TOOL IN IDENTIFYING
THE PATIENTS THAT ARE DEVELOPING
SEPSIS BUT TTION HELPFUL IN THAT
IT CAN IDENTIFY PATIENTS EARLY
SO THEY GET THAT EARLY TREATMENT
THAT WE'RE LOOKING FOR AND
POSSIBLE ESCALATION OF CARE.
SO WE'RE DOING MORE WORK TO HELP
IDENTIFY PATIENTS THAT YOU MIGHT
EXPECT TO DECOMPENSATE OR
DEVELOP SEPSIS SO THAT WE CAN
MAKE SURE THOSE PATIENTS GET THE
CARE THAT THEY NEED EARLY
BECAUSE CHORIOAMNIONITIS IS NOT
UNCOMMON.
IT'S ABOUT 2 TO 5% OF PATIENTS.
SO IN SUMMARY, FOR THAT WORK,
INTRAPARTUM SCREENING WE
DISCUSSED, ENDOMETRITIS AND
CHORIOAMNIONITIS IS A CHALLENGE
BECAUSE OF THE VERY HIGH RATES
OF FALSE POSITIVES BUT ONE OTHER
THING I DIDN'T SHARE BECAUSE WE
DON'T HAVE TIME FOR THAT BUT IN
THE ANSWER TO PART OF MY
POSTPARTUM SCREENING WE FOUND
THAT THE BEST TIME TO USE THE
PREGNANCY ADJUSTED TOOLS ARE
AFTER 20 WEEKS GOING UP UNTIL
ABOUT THREE DAYS POSTPARTUM
AROUND THE TIME PATIENT GO HOME
FROM THE HOSPITAL.
THE REASON FOR THAT IS THAT
PRIOR TO THAT TIME, LESS THAN 20
WEEKS AND THEN ALSO AFTER THE 72
HOURS, 48 TO 72 HOURS AFTER
DELIVERY, THE CHANGES LIKE TO
INCREASE THE HEART RATE THE
FIRST 20 WEEKS, IT TAKES TIME
AND THESE PREGNANCY ADJUSTED
TOOLS HAVE AN ELEVATED HEART
RATE THRESHOLD AND A NUMBER OF
OTHER THINGS THAT IF YOU WERE TO
USE THE PREGNANCY ADJUSTED
CRITERIA AS SOON AS SOMEONE
BECAME PREGNANT ALL THE WAY UP
UNTIL SIX WEEKS YOU WOULD
ACTUALLY MISS SEVERAL PATIENTS
AND THE REASON FOR THAT IS THAT
THEY MAY NOT HAVE INCREASED
THEIR HEART RATE YET EARLY IN
PREGNANCY AND AFTERWARD THEY MAY
HAVE DECREASED THEIR HEART RATE
PRETTY QUICKLY, AND THAT
ELEVATED THRESHOLD IS GOING TO
MAKE IT WHERE THEY MAY NOT MEET
THEIR CRITERIA.
SO THIS CONVENIENTLY LINES UP
WITH IN THE ER MANY PATIENTS AND
MANY HOSPITALS, THEY SEE
PATIENTS LESS THAN 20 WEEKS AND
THEN ALSO ONCE THEY'RE
DISCHARGED HOME FROM THE
HOSPITAL WITH READMISSION FROM
THE HOSPITAL AND PRIOR TO THIS
MANY TIMES IN THE ER THEY DON'T
WANT TO BE USING THEIR SCREENING
CRITERIA BECAUSE, WELL, WE KNOW
PREGNANT PATIENTS MIGHT NEED
DIFFERENT CRITERIA AND IT'S
JESUS GOING TO BE FA JUST
GOING TO BE FALSELY POSITIVE,
BUT THE GREAT THING THAT THIS
SHOWS IS THAT THERE ARE STILL A
LOT OF FALSE POSITIVES, I WON'T
SAY THAT THERE ARE NOT, BUT WE
STILL SAY THEY CAN USE THEIR OWN
CRITERIA THAT THEY'RE
COMFORTABLE WITH USING ALREADY
IN THE NON-PREGNANT PATIENTS AND
THAT WAY WE WON'T MISS AS MANY
PATIENTS.
SO I THINK THAT THAT WAS AN
IMPORTANT FINDING.
SO WE TALKED ABOUT IN THE
HOSPITAL.
REMEMBER WE TALKED ABOUT THAT'S
JUST THAT SMALL DOT, THAT THREE
TO FOUR DAYS WHILE THEY'RE IN
THE HOSPITAL.
AND AS WE KNOW PATIENTS DON'T
LIVE THEIR LIVES IN A HOSPITAL
SO HOW CAN WE HELP THEM IDENTIFY
WHEN TO SEEK CARE AND HELP THE
PATIENT BE LISTENED TO AND FEEL
HEARD BECAUSE MOST CASES
ACTUALLY OCCUR OUTSIDE OF THE
HOSPITAL.
SO WE DID SOME QUALITATIVE WORK
INTERVIEWING PATIENTS AND WE
INTERVIEWS 20 PATIENTS IN THE
QUALITATIVE STUDY, WE FOUND WE
INTERVIEWED 19 SURVIVORS, WE
INVITED THEM TO BRING ANY
SUPPORT PERSON, THIS CAME OUT OF
HOUR COMMUNITY BOARD, THAT MANY
PEOPLE WERE SEDATED, THEY WERE
EITHER CONFUSED BUT THEY MAY NOT
REMEMBER EVERYTHING SO WE WANTED
TO MAKE SURE THE SUPPORT PERSON
WAS THERE TO HELP FILL IN THE
GAPS THERE SO PEOPLE BROUGHT
THEIR SUPPORT PERSON AND THEN WE
WERE ALSO ABLE TO TALK TO A
SUPPORT PERSON OF A NON-SURVIVOR
AND THESE WERE RECRUITED
THROUGHOUT THE COUNTRY.
WE ALSO USED OUR COMMUNITY
BOARD, THEY WERE VERY HELPFUL IN
SHARING THE FLYER WITHIN THEIR
COMMUNITIES LIKE THEIR CLOSED
FACEBOOK GROUPS OF SURVIVORS AND
WE GOT SOME REALLY RICH DATA
FROM THAT.
AND OUR GOALS WERE TO IDENTIFY
BARRIERS TO CARE, LISTEN TO
PATIENT STORIES AND LESSONS
LEARNED AND TO CREATE SOLUTIONS
TO THOSE BARRIERS.
SO WE HAD A WIDE RANGE OF AGES
AS WELL AS YEARS THAT SEPSIS
OCCURRED AND WE HAD A DIVERSE
GROUP THAT WE INTERVIEWED AND
MOST PATIENTS WERE FROM
UNDERREPRESENTED MINORITY
GROUPS.
ONE OF THE FIRST FINDINGS THAT
WE HAD, ONE OF THE THEMES WAS
THAT PATIENTS DID NOT REMEMBER
EDUCATION ABOUT THE WARNING
SIGNS.
SO WE EITHER WERE NOT GIVING TO
THEM OR NOT GIVING TO THEM IN A
WAY THAT WAS ACCESSIBLE.
AND ONE OF THE EXEMPLARY QUOTES
WAS, I THINK IF WHEN THEY
DISCHARGED ME IF THEY HAD SAID
BE ON THE LOOKOUT FOR THESE, IF
THEY HAD TAKEN FIVE MINUTES TO
DO THAT I THINK IT WOULD HAVE
MAIJ A HUGE DIFFERENCE.
SO AS APRIL TALKED ABOUT THESE
URGENT MATERNAL WARNING SIGNS,
THESE WERE CREATED BY THE
COUNCIL FOR PATIENT SAFETY AND
WOMEN'S HEALTHCARE, THEY ARE
COPYRIGHTED BY THE AMERICAN
COLLEGE OF OBSTETRICIANS AND
GYNECOLOGISTS AND THEY ARE ALSO
USED BY THE HEAR HER CAMPAIGN BY
CDC.
THEY'VE NOW BEEN TRANSLATED INTO
80 LANGUAGES AND IT PROVIDES
STANDARDIZED PATIENT EDUCATION
SO THAT PATIENTS CAN REALLY HEAR
WHAT THESE WARNING SIGNS ARE AND
ALSO HAVE SOME INFO GRAPHICS TO
REFER TO IF THEY HAVE ANY
THOUGHTS, ANY QUESTIONS ABOUT
WHAT'S GOING ON.
WE ALSO TALKED ABOUT THIS WITH
THE PEOPLE WE INTERVIEWED AS
WELL AS THE COMMUNITY LEADERSHIP
BOARD AND THIS CAME OUT OF
THEIR -- ALL OF THESE
DISCUSSIONS WAS THAT WE REALLY
WANTED -- THE PATIENTS REALLY
WANTED SOMETHING ON THEIR PHONE.
THEY SAID THIS AGAIN AND AGAIN,
WE ASKED THEM IN THE INTERVIEW
WHAT WOULD BE HELPFUL TO GIVE
YOU THIS INFORMATION, HOW WOULD
YOU LIKE TO RECEIVE IT.
EVERYONE SAID THEY WANTED IT ON
THEIR PHONE, NO ONE WANTED THE
PACKETS THAT PEOPLE GIVE OUT ON
L & D, THEY NEVER MADE IT OUT OF
THE CAR, THEY WENT INTO THE
GARBAGE.
SO WE CREATED A BADGE BUDDY THAT
WE DISTRIBUTED ACROSS THE STATE
TO HAVE THIS QR CODE, THIS IS
LIVE, YOU CAN SCAN IT, AND USE
THE INSTRUCTIONS TO MAKE A
BOOKMARK ON YOUR PHONE SO THAT
YOU HAVE ACCESS TO THESE
RESOURCES, THE WARNING SIGNS, AS
WELL AS OTHER RESOURCES THAT I
WANT TO SHARE WITH YOU.
SO THIS WAS GREAT IN THAT WE --
ONE OF THE COMMENTS THAT WE
HEARD FROM THE COMMUNITY BOARD
WAS THAT WE CAN'T JUST GIVE
PEOPLE THE WARNING SIGNS.
WE ACTUALLY HAVE TO HELP THEM
ADVOCATE FOR THEMSELVES AS WELL
BECAUSE MANY PEOPLE JUST WEREN'T
BEING HEARD AS YOU HEARD IN
APRIL'S STORY.
SO WE DID SOME ADVOCACY LANGUAGE
AND ACTIONS BUT -- NOT JUST
PATIENTS THAT WERE PREGNANT OR
THEIR SUPPORT PERSON.
WE KNOW THAT WHEN SOMEONE'S
EXPERIENCING SYMPTOMS, THEY
USUALLY CALL THEIR FRIENDS OR
FAMILY SO FOR AN EXAMPLE, WHEN
MEN EXPERIENCE CHEST PAIN THEY
USUALLY CALL THEIR PARTNER, AND
IT'S BASED ON THEIR PARTNER'S
RESPONSE IS WHY -- HOW URGENT
AND WHEN THEY SEEK MEDICAL CARE.
AND UNFORTUNATELY, THERE'S ALSO
SOME DATA THAT SOME WOMEN, WHEN
THEY EXPERIENCE CHEST PAIN, THEY
DO THE SAME THING.
AND DESPITE THAT IT ONE OF THE
LEADING CAUSES OF DEATH FOR
WOMEN, CARDIOVASCULAR DISEASE,
THEY DON'T GET THE SAME URGENCY
AND THEY ACTUALLY HAVE DELAYED
CARE SOMETIMES BECAUSE OF
CHEST -- WITH CHEST PAIN.
AND SO WE THOUGHT THAT MAYBE THE
SAME THING IS HAPPENING WITH
PREGNANT PATIENTS IN THAT THEY
DON'T KNOW THE WARNING SIGNS SO
MAYBE THEY'RE EXPERIENCING A
HEADACHE THAT'S PRETTY SEVERE,
THEY CALL ONE OF THEIR FRIENDS
OR A FAMILY MEMBER, WHY DON'T
YOU TAKE SOME TYLENOL, TAKE A
NAP, NOT REALIZING THAT COULD BE
A WARNING SIGN FOR PRE-ECLAMPSIA
ALL OF THOSE WARNING SIGNS I
SHOWED ARE NOT ONLY FOR SEPSIS,
THEY'RE ALSO FOR MATERNAL
MORBIDITY.
SO WE DID A REALLY INCREDIBLE
COMMUNITY AND PUBLIC HEALTH
DISSEMINATION OF THESE BADGE
BUDDIES AND THAT PUBLIC HEALTH
IN THE STATE AS WELL AS THE WIC
AGENCIES WERE USING THE BADGE
BUDDIES, MAKING SURE PEOPLE HAD
THE INFORMATION ON THEM.
THERE WERE ALSO COMMUNITY-BASED
ORGANIZES WE WORKED WHO MADE
SURE THE BADGE BUDDY WAS THE
SIZE OF A CREDIT CARD SO IT
WOULD FIT IN A WALLET SO IF
PEOPLE, IF THEY WEREN'T WEARING
A BADGE, THEY COULD BE A
CHAMPION OF THAT.
THEY COULD SCAN THE BADGE AND
SHARE THAT WITH PEOPLE.
AS WELL AS HOUSES OF WORSHIP
WILL ALSO HELPING US WITH THIS,
AND THE MEDICAID SUPPORTED
DOULAS IN THE STATE OF MICHIGAN
AS WELL AS THE HOME VISITING
NURSING PROGRAM THAT SERVES
THOUSANDS OF POSTPARTUM
PATIENTS.
WE WERE ALL DISTRIBUTING IT
THROUGHOUT THAT STATE SO THAT WE
COULD MAKE SURE EVERYONE KNEW
ABOUT IT SO IF THEY WERE CALLED,
THEY KNEW LET ME CHECK MY LIST
AND SEE IF THAT'S SOMETHING WE
SHOULD BE CONCERNED ABOUT.
SO REMEMBER WE TALKED ABOUT ADD
ADVOCACY.
WE REALIZED WE HAD TO DO
SOMETHING NOT SAYING THAT WE
NEED TO PUT THE ONUS ON THE
PATIENT THAT THEY HAVE TO
ADVOCATE FOR THEMSELVES TO GET
THE CARE THAT THEY NEED, BUT WE
WANTED TO HE'LLIZE THAT WE NEED
TO DO BETTER LISTEN TO PATIENTS
BUT IN THE MEANTIME WE NEED TO
GIVE PEOPLE THE TOOLS.
SO ONE OF THE THEMES THAT WE
FOUND WAS THAT PATIENTS WANTED
TO ADVOCATE FOR THEMSELVES AND
THEY WANTED TO LEARN HOW TO DO
THAT.
ONE OF THE QUOTES, I WISH
SOMEONE WOULD HAVE EXPLAINED IT
ZOO SCIENCE AND HOW TO ADVOCATE
FOR THEMSELVES.
LIKE IF YOU CALL AND THEY TELL
YOU DON'T COME, STILL GO.
SO WE WORKED WITH OUR COMMUNITY
LEADERSHIP BOARD AS WELL AS OUR
CLINICAL ADVISORY BOARD TO
CREATE ADVOCACY LANGUAGE AND
ACTIONS.
WE DID A PROCESS, WE DID
MULTIPLE MEETINGS, MULTIPLE
ITERATIONS, WE USED JAMBOARD,
AND EVERYONE PUT THEIR COMMENTS
IN THERE SO THAT WE COULD TAKE A
LOOK AND PUT TOGETHER A DOCUMENT
THAT WE COULD SHARE WITH
PATIENTS WITH THAT BADGE BUDDY.
SO HERE IS THE ADVOCACY LANGUAGE
AND ACTIONS, AND SO JUST SOME
EXAMPLES OF ADVOCACY LANGUAGE IS
THAT IF THEY WERE BEING BRUSHED
OFF, THEY COULD SAY SOMETHING
THAT'S ON THIS LIST SUCH AS THIS
IS SOMETHING REALLY DIFFERENT
FOR ME, I'VE NEVER FELT THIS WAY
IN HIGH LIFE.
FOR MY BENEFIT AND MY FAMILY'S
BENEFIT, I SHOULD BE SEEN.
THEN ADVOCACY ACTION TIPS SUCH
AS BRINGING SOMEONE WITH YOU TO
HELP ADVOCATE FOR YOU, AND THEN
ALSO MANY PATIENTS DIDN'T KNOW
THAT IF THEY WERE GETTING A
CALL -- THEY WERE CALLING
THROUGH TRIAGE OR THROUGH
CLINIC, IF THEY WERE BEING TOLD
THAT THEY DIDN'T NEED TO BE
EVALUATED, EVEN IF THEY DIDN'T
FEEL RIGHT OR IF THINGS
WORSENED, THEY DIDN'T REALIZE
THAT THEY ACTUALLY COULD GO TO
THE ER OR 5 GO TO TRIAGE.
THAT CAME UP A NUMBER OF TIMES.
SO WE WANTED TO GIVE THEM THAT
REASSURANCE AND HEAR THAT THIS
IS SOMETHING THAT COULD BE
SHARED.
WE HAD A LOT OF REALLY GREAT
RESPONSE FROM THIS DOCUMENT,
FROM THE COMMUNITY-BASED
ORGANIZATIONS AND THAT'S WHY
THEY ALSO WANTED TO START
PARTICIPATING IN SHARING THIS.
YOU HEARD APRIL'S STORY AND
ALSO -- HER STORY IS
UNFORTUNATELY SOMEWHAT TYPICAL
OF THE PATIENTS THAT WE
INTERVIEWED, AND I'M SURE THAT
THAT'S NOT ALL OF THE STORIES
THAT I'M SURE WERE SHARED
EVERYWHERE, BUT THIS WAS AN
IMPORTANT ONE.
THIS QUOTE WAS FROM THE SPOUSE
WHOSE WIFE DIED, SHE'S DISMISSED
THERE AND THROUGHOUT THE WHOLE
STAY WHENEVER WE BROUGHT THESE
THINGS UP WAS YOU JUST HAD A
BABY, EVERYTHING'S OKAY, DON'T
WORRY, YOU JUST HAD A BABY, AND
THAT WAS THE RECURRING THEME
THROUGHOUT OUR STAY.
BUT THEY DIDN'T REALLY ASK
FURTHER AND GET MORE
INFORMATION.
A LOT OF PEOPLE JUST RECEIVED A
LOT OF REASSURANCE BECAUSE MOST
OF THE TIME, EVERYTHING IS OKAY.
BUT THEY DIDN'T GET A LOT OF
DEPTH ABOUT WHAT WAS GOING ON.
SO THERE WERE SOME OTHER PEOPLE
THAT WE HAD INTERVIEWED THAT IS
PRETTY COMMON TO TALK ABOUT THE
ENTIRE POSTPARTUM, BUT NO ONE
REALLY ASKED THEM, WHAT DOES
THAT MEAN TO YOU?
WHAT DO YOU MEAN BY THAT?
SO MANY OF THESE QUOTES, THREE
DIFFERENT PEOPLE, I HAD NO
STRENGTH, I COULDN'T EVEN GO TO
THE KITCHEN TO GET A GLASS OF
WATER.
I WAS SO WEAK I COULDN'T STAND
UP.
I WAS SHORT OF BREATH AFTER
BRUSHING MY TEETH AND HAD TO LIE
DOWN ON THE BED.
THIS IS MUCH MORE SERIOUS IN
THAT THESE PEOPLE COULD NOT DO
ACTIVITIES OF DAILY LIVING.
SO WE WORKED WITH OUR COMMUNITY
BOARD AS WELL AS OUR CLINICAL
ADVISORY BOARD TO CREATE A
WARNING SIGNS FOLLOW-UP GUIDE
AND WE DID THE SAME PROCESS AND
THIS IS A SET OF QUESTIONS, GIVE
SOME INFORMATION ABOUT WHAT
LESSONS LEARNED FROM THIS STUDY
AS WELL AS IN OTHER DATA THAT'S
OUT THERE, BUT GIVING SOME
FOLLOW-UP QUESTIONS ABOUT REALLY
GETTING A GOOD HISTORY FROM
THOSE PATIENTS BEFORE
REASSURING, AND THEN ALSO JUST
GIVING SOME ACTION ITEMS OF
TELLING THAT PATIENT EVEN IF
THEY DON'T NEED TO BE EVALUATED
NOW, WHEN SHOULD THEY, IF IT
PERSISTS, IF IT GOT WORSE, A LOT
OF PEOPLE REALIZED THAT THEY HAD
TALKED TO SOMEONE, AND THEY
THOUGHT EVERYTHING WAS CLEARED
UP THEY DIDN'T HAVE TO CHECK IN
AGAIN BUT THEY DIDN'T REALIZE IF
THINGS PERSISTED OR IF THEY GOT
WORSE, THEY DIDN'T KNOW WHAT
SIGNS THEY SHOULD BE AWARE OF TO
SEEK CARE.
THERE'S ALSO SOME RED FLAGS HERE
FROM OUR DATA AS WELL AS OTHER
DATA ABOUT WHEN PEOPLE SHOULD
REALLY BE SEEN IN PERSON, THAT
WE CONVENIENTLY PUT ON THE BADGE
BUDDY, YOU'LL SEE THERE'S
PATIENT RESOURCES AND PROVIDER
RESOURCES, IT'S HELPFUL FOR
PEOPLE, THEY'RE ALREADY WEARING
IT AROUND THEIR NECK TO BE ABLE
TO ACCESS THOSE RESOURCES AS
NEEDED.
>> I THINK WE'RE AT TIME, SO
PERHAPS YOU COULD WRAP UP?
>> OH, SURE.
SORRY.
AND THEN TREAT TREATMENT, WE TAD
ABOUT ANTIBIOTICS ARE INCREDIBLY
IMPORTANT.
I HAVE LIKE TWO MORE SLIDES
HERE.
AND THEN ALSO GIVING SOME
STRATEGIES ON GIVING THOSE
ANTIBIOTICS IN QUICKLY.
AND THENS CLAITION OF RESOURCE,
WE ALSO PROVIDED TO PEOPLE USING
THE SEPSIS OBSTETRICS SCORE WITH
THE RESOURCE CONVENIENTLY, AND
NEXT STEPS WE'RE COMPLETING OUR
IMPLEMENTATION, DOING OUR DATA
ANALYSIS AND PATIENT-CENTERED
QUALITATIVE ASSESSMENT OF THE
TOOLS.
I CAN'T SAY ENOUGH ABOUT THIS
INCREDIBLE TEAM.
I WANT TO THANK ALL OF THE
PEOPLE YOU SEE HERE AS WELL AS
THE CLINICAL ADVISORY BOARD AND
THE COMMUNITY LEADERSHIP BOARD.
AND THANK YOU FOR OPPORTUNITY TO
SPEAK HERE TODAY.
I'M HAPPY TO PASS IT BACK OVER.
>> THANK YOU, DR. BAUER.
UNFORTUNATELY WE DON'T HAVE TIME
FOR QUESTIONS BECAUSE WE STILL
HAVE A NUMBER OF PRESENTATIONS
TO GO THROUGH.
BUT IF PEOPLE HAVE QUESTIONS FOR
DR. BAUER, PUT THEM IN THE CHAT
BOX, AND WE CAN GET THEM TO HER.
BUT IT WAS REALLY A VERY
IMPACTFUL TALK, PARTICULARLY IN
THE CONTEXT OF APRIL PRESENTING
WHAT SHE HAD BEEN THROUGH.
SO AT THIS TIME, WE'RE GOING TO
TAKE ANOTHER 10-MINUTE BREAK.
WE WILL COME BACK AT 3:40.
AND THEN WE WILL GO THROUGH THE
CONCEPT CLEARANCES.
SO THANK YOU, DR. BAUER,
DR. MARRAZZO, IF YOU'RE STILL ON
AND MS. CHAVEZ.
>> IT'S EXACTLY 340 TYPE, AND
I'M GOING TO HAND THE MICROPHONE
OVER FOR THE CONCEPT CLEARANCES.
>> WELCOME BACK.
WE'RE NOW GOING TO PRESENT FOUR
CONCEPTS FOR YOUR CONSIDERATION.
FOR EACH CONCEPT, I WILL ASK THE
STAFF TO PROVIDE A BRIEF
OVERVIEW OF THE INITIATIVE AND
THEN ASK COUNCIL FOR DISCUSSION
REGARDING THE CONCEPT.
AT THE CONCLUSION OF THE
DISCUSSION FOR EACH CONCEPT,
I'LL ASK COUNCILMEMBERS WHETHER
THEY CONCUR OR NOT.
I JUST WANTED TO REMIND
ESPECIALLY WITH ALL OUR NEW AD
HOC MEMBERS AND SUBJECT MATTER
EXPERTS REMIND YOU, CONCEPTS
REPRESENT THE EARLY PLANNING
STAGES FOR FUNDING INITIATIVES
SUCH AS A REQUEST FOR
APPLICATIONS OR A CONTRACT
SOLICITATION.
ACCORDING TO LAW, EXPERTS IN THE
FIELD WHICH ARE USUALLY
COUNCILMEMBERS MUST APPROVE A
CONCEPT BEFORE IT CAN BE
ANNOUNCED OR DEVELOPED INTO A
FUNDING INITIATIVE.
COUNCILMEMBERS ARE ASKED TO
REVIEW, COMMENT ON AND APPROVE
THE CONCEPT'S SCIENTIFIC MERIT
AND RELATIVE PRIORITY.
BUT PLEASE REMEMBER THAT NOT ALL
CONCEPTS ARE DEVELOPED INTO
FORMAL INITIATIVES.
AND EVEN IF A CONCEPT DOES LEAD
TO AN INITIATIVE, THE DETAILS
MAY DIFFER FROM THE ORIGINAL
PROPOSAL.
CONCEPTS ARE PRESENTED IN OPEN
SESSION, THEY DO NOT INCLUDE
SPECIFIC DETAILS ABOUT POTENTIAL
FUTURE FUNDING INITIATIVES, AND
THIS IS ACTUALLY A PROTECTION
FOR YOU, THE COUNCILMEMBERS,
SINCE THERE WAS NO, SO TO SPEAK,
INSIDE INFORMATION, YOU ARE
PERMITTED TO APPLY TO ANY FUTURE
INITIATIVES.
SO HAVING SAID THAT, LET ME
INTRODUCE DR. FRANKLIN YATES
FROM THE MATERNAL AND PEDIATRIC
INFECTIOUS DISEASE BRANCH, WHO
WILL PRESENT ADVANCING
PREVENTION AND TREATMENT OF
BACTERIAL STIs IN HIV-AFFECTED
ADOLESCENT AND MATERNAL
POPULATIONS.
>> THANK YOU AND GOOD AFTERNOON.
PROGRAM SEEKS COUNCIL APPROVAL
NEW INITIATIVES TITLED ADVANCING
PREVENTION AND TREATMENT OF
BACTERIAL STI IN HIV AFFECTED
ADOLESCENT AND MATERNAL
POPULATIONS.
DESPITE DEVELOPMENTS -- DATA
FROM THE U.S. CENTERS FOR
DISEASE CONTROL AND PREVENTION
SHOW THAT RATES OF INFECTION
WITH SYPHILIS, GONORRHEA AND
CHLAMYDIA MARKEDLY INCREASED
OVER THE PAST 10 YEARS AMONG
ADOLESCENTS -- OR GREATER
LIKELIHOOD OF HIV.
SIMILARLY A DISPROPORTIONATE
INCREASE IN SYPHILIS RATES AMONG
ADOLESCENT GIRLS AND YOUNG -- OF
REPRODUCTIVE AGE HAS LED TO
POINTED INCREASE IN CONGENITAL
SYPHILIS CASES NATIONWIDE.
AS ON A RISE IN THE U.S.
AFFECT -- AT ALARMING RATES, STI
RESEARCH OUTPUT POPULATIONS HAS
NOT BEEN -- WHILE
PATHOPHYSIOLOGY, DIAGNOSTICS AND
THERAPEUTICS HAVE BEEN STUDIED
IN ADULTS, RESEARCH ON CLINICAL
MANAGEMENT AND DISSEMINATION AND
IMPLEMENTATION FOCUSING ON
MATERNAL -- POPULATIONS AFFECTED
BY HIV IS LACKING.
THE GOALS OF THIS INITIATIVE
INCLUDE THE FOLLOWING.
ONE, TO IMPROVE OUR
UNDERSTANDING OF HIV AND
BACTERIAL STI EP DE EPIDEMIOLOGC
TRENDS, RELATIONSHIPS,
CAUSALITIES AMONG THESE HIGH
BURDEN POPULATIONS, TWO, TO
AUGMENT RESEARCH ON DIAGNOSTIC
MODALITIES AND SAFE AND
EFFECTIVE MICROBE CIDAL AGENTS
AND THEIR CLINICAL
IMPLEMENTATION.
THREE, TO AUGMENT DISSEMINATION
AND IMPLEMENTATION RESEARCH ON
EVIDENCE-BASED STI PREVENTION
AND TREATMENT STRATEGIES FOR
YOUTH AND MATERNAL HIV AFFECTED
POPULATIONS.
THIS PROPOSED CONCEPT ALLIANCE
WITH THE NICHD'S STRATEGIC
THEMES THREE, FOUR AND FIVE, AND
WITH THREE MATERNAL AND
PEDIATRIC INFECTIOUS DISEASE
BRANCH PROGRAMMATIC PRIORITIES.
THE INITIATIVE ALSO ADDRESSES
THREE OVERARCHING HIV/AIDS
PRIORITIES INCLUDING RESEARCH ON
HIV ASSOCIATED COINFECTIONS,
REDUCING HEALTH DISPARITIES AND
TRAINING OF THE RESEARCH
WORKFORCE.
THANK YOU.
>> THANK YOU, DR. YATES.
ARE THERE ANY COMMENTS OR
QUESTIONS ABOUT THIS CONCEPT?
DR. CEDARS?
>> YES, THANK YOU FOR THAT
PROPOSAL AND PARTICULARLY IN THE
CONTEXT OF THE EXCELLENT
PRESENTATION FROM DR. MARRAZZO.
IS THERE COORDINATION WITH NIAID
ON THIS GIVEN THE STRONG OVERLAP
IN THE GOALS?
>> YES, THERE IS.
WE HAVE BEEN IN COORDINATION
WITH THE STD BRANCH IN NIAID'S
DIVISION OF MICROBIOLOGY AND
INFECTIOUS DISEASES, AND WE HAVE
SO FAR RECEIVED THEIR
INTELLECTUAL SUPPORT AND MORE
POTENTIALLY TO COME?
>> ANOTHER COMMENT FROM
DR. WOLFNER ALSO IN THE CHAT
ALONG SIMILAR LINES ABOUT
COLLABORATING WITH NIAID.
DR. COLE?
YOU MIGHT BE MUTED.
>> SESH, WE CAN'T HEAR YOU.
>> CAN YOU HEAR ME NOW?
>> YEAH.
>> YES.
>> NO, I'M AFRAID WE'VE LOST YOU
AGAIN.
>> HOW ABOUT NOW?
>> THAT'S GOOD.
THANK YOU.
>> SORRY.
MY TECHNICAL DETAILS HERE.
SO THIS IS A GREAT INITIATIVE.
WITH THE NOTICE OF FUNDING
OPPORTUNITY LIKELY INCLUDE AN
INTENTIONAL EXPECTATION OF
ENGAGING POPULATIONS WHO HAVE
EXPERIENCED HEALTH DISPARITIES?
>> YES, I THINK THAT'S GOING
TO -- THAT WILL BE PART OF THE
NOFO.
>> I THINK THAT'S IMPORTANT, TO
BE SURE THAT THERE ARE
IDENTIFIABLE AND REVIEWABLE
STRATEGIES FOR THAT.
THANK YOU.
>> THANK YOU.
>> ARE THERE ANY OTHER
ADDITIONAL COMMENTS OR
QUESTIONS?
NOT HEARING ANY, CAN I HAVE A
MOTION FOR APPROVAL?
>> SO MOVED.
THIS IS DR. COLE.
>> SO I'M GOING TO ASK FOR THE
MOTIONS AND THE VOTES AND
THE SECONDS TO COME FROM OUR
SEVEN COUNCILMEMBERS.
>> SORRY.
>> NO, NOT AT ALL.
IT'S JUST FORMALITY.
SO COUNCILMEMBERS?
>> THIS IS IGNA.
MOVE IT BE APPROVED.
>> CYNTHIA, SECOND.
>> THANK YOU SO MUCH.
ALL IN FAVOR?
>> WE HAVE SEVEN YESES.
>> ALL RIGHT, THANK YOU.
WE'LL NOW MOVE ON TO THE SECOND
CONCEPT.
I'M GOING TO INTRODUCE DR. LESLY
SAMEDY-BATES FROM THE OBSTETRIC
AND PEDIATRIC PHARMACOLOGY AND
THERAPEUTICS BRANCH WHO WILL
PRESENT MATERNAL AND PEDIATRIC
PRECISION IN THERAPEUTICS OR
MPRINT.
>> THANK YOU AND GOOD AFTERNOON.
COUNCIL SEEKS APPROVAL FOR THE
MATERNAL AND PEDIATRIC PRECISION
AND THERAPEUTICS INITIATIVE
OTHERWISE KNOWN AS MPRINT
VERSION 2.0.
MPRINT WILL AGGREGATE, EXPAND
AND PRESENT KNOWLEDGE, TOOLS AND
EXPERTISE IN MATERNAL, LACTATION
AND PEDIATRIC THERAPEUTICS
ULTIMATELY BENEFITING THE
BROADER RESEARCH REGULATORY
SCIENCE AND DRUG DEVELOPMENT
COMMUNITIES.
THIS IS DESIGNED TO ADVANCE
PROGRESS IN THERAPEUTIC RESEARCH
AND POPULATIONS THAT HAVE
HISTORICALLY LAGGED IN ADVANCES.
PROPOSED GOALS WILL COMPLEMENT
AND BUILD ON ONGOING MPRINT
EFFORTS.
THERE WILL BE A FOCUSED SCOPE
FOREKNOWLEDGE BASED INTEGRATION,
STRONGER PRESENCE IN NICHD
CLINICAL TRIAL NETWORKS AND
ENHANCED RESOURCE FOR
DISSEMINATION EFFORTS.
THERE WILL BE A COMMITTED FOCUS
ON EXPLORING THE EFFECTS OF
MEDICATION CLASSES ON HUMAN MILK
COMPOSITION, ON PEDIATRIC AND
MATERNAL PHARMACOGENOMICS AND ON
LEVERAGING REAL WORLD EVIDENCE
TO ADDRESS KEY KNOWLEDGE DPAPS.
GAPS.
THIS ALIGNS WITH NICHD'S
STRATEGIC PLAN, PARTICULARLY
THEME FIVE, THAT WILL SUPPORT
THE BEST PHARMACEUTICALS FOR
CHILDREN AFTER BPCA AS WELL AS
THE RESEARCH SPECIFIC TO
PREGNANT AND LACTATING WOMEN
EFFORTS OTHERWISE KNOWN AT
PRGLAC.
IT ALSO ADDRESSES RESEARCH
PRIORITIES OVER SEVERAL NICHD
BRANCHES.
ADDITIONALLY, MPRINT HAS THE
POTENTIAL TO ACCELERATE HIV AND
AIDS RESEARCH THROUGH
MULTIDISCIPLINARY COLLABORATIONS
AND INNOVATIVE APPROACHES.
KEY EFFORTS INCLUDE
PHARMACOMETRIC ANALYSES AND
ANTIINFECTED DRUG DEVELOPMENT
AND STUDIES ON THE EFFECTS OF
ANTIINFECTIVE AGENTS ON HUMAN
MILK COMPOSITION.
CREATING SYNERGIES ACROSS
INSTITUTE FUNDED INITIATIVES
PAVING THE WAY FOR THE
DEVELOPMENT OF SAFE AND
EFFECTIVE THERAPEUTICS FOR
MATERNAL AND PEDIATRIC
POPULATIONS.
SOME KEY OUTCOMES OF THE CURRENT
INITIATIVE INCLUDE DEVELOPMENT
OF THE KNOWLEDGE BASE, THE
ONTOLOGY AND LITERATURE DATA
EX-TRACK TOOL IN PORTAL,
DEVELOPMENT -- AND DEVELOPMENT
OF PEDIATRIC FEE CODES AND TOOLS
TO TRACK MATERNAL OPIOID USE.
MPRINT HAS BEEN TREMENDOUSLY
SUCCESSFUL IN MAKING PROGRESS
TOWARDS ITS CURRENT GOALS.
THANK YOU.
>> THANK YOU.
ARE THERE QUESTIONS OR COMMENTS?
NOT HEARING ANY, OR SEEING ANY
IN THE CHAT, MAY I ASK FOR A
MOTION TO APPROVE?
>> MOTION TO APPROVE.
>> THANK YOU.
AND A SECOND?
>> SECOND.
>> I'LL SECOND.
>> AND ALL IN FAVOR?
>> WE HAVE SEVEN YES VOTES.
>> THANK YOU SO MUCH.
NEXT UP, WE HAVE DR. LEIGH ALLEN
FROM THE CONTRACEPTION RESEARCH
BRANCH, WHO WILL BE PRESENTING
EFFECTS OF CONTRACEPTION AS
TREATMENT FOR GYNECOLOGIC
DISORDERS.
DR. ALLEN.
>> GOOD AFTERNOON, EVERYONE, AND
THANK YOU.
PROGRAM SEEKS COUNCIL APPROVAL
FOR AN INITIATIVE TITLED EFFECTS
OF CONTRACEPTION AS TREATMENT
FOR GYNECOLOGIC DISORDERS.
THE ROUGHLY 100 U.S. MARKETED
CONTRACEPTIVES ARE USED SAFELY
BY MOST PEOPLE FOR
CONTRACEPTION.
HOWEVER, MANY OF THE PRODUCTS
ARE USED LONG TERM, OFTEN OFF
LABEL, TO TREAT GYNECOLOGIC
CONDITIONS SUCH AS POLYCYSTIC
OVARY SYNDROME, ENDOMETRIOSIS,
AND FIBROIDS, WHICH AFFECT
MILLIONS OF U.S. WOMEN.
THE COMMON THEME ACROSS THESE
INDICATIONS IS A LACK OF
SPECIFIC TREATMENTS.
THOUGH HORMONAL CONTRACEPTIVES
ARE TYPICALLY USED BUT THERE ARE
SCANT DATA ON THE EFFECTIVENESS
OF DIFFERENT HORMONAL PRODUCTS
AND REGIMENS.
THE GOALS OF THIS INITIATIVE ARE
TO, ONE, SUGGEST TREATMENT
GUIDELINES TO AID PATIENT
OUTCOMES AND SATISFACTION WHILE
GENERATING DATA TO DRIVE BEST
PRACTICES, AND TWO, OBTAIN
INSIGHT INTO DRIVERS OF
CONTRACEPTIVE CHOICE IN TREATING
GYNECOLOGIC CONDITIONS.
THE CURRENT SCIENTIFIC
LITERATURE IS INADEQUATE AS TO
RELATIVE EFFECTIVENESS OF
CONTRACEPTIVE TREATMENTS IN THE
CONTEXT OF OPTIMIZING
GYNECOLOGIC DISEASE OUTCOMES.
THIS INITIATIVE WOULD ADDRESS
THE CURRENT LACK OF SUPPORTING
DATA AND RIGOR.
THIS PROPOSED CONCEPT ALIGNS
WITH NICHD'S STRATEGIC THEMES
TWO AND FIVE, AND NICHD
ASPIRATIONAL GOAL, A
CROSS-CUTTING TOPIC OF HEALTH
DISPARITIES, INTEREST ACROSS
MULTIPLE BRANCHES, AND A
CONTRACEPTION RESEARCH BRANCH
PROGRAMMATIC PRIORITY.
THANK YOU.
>> THANK YOU VERY MUCH.
ARE THERE QUESTIONS OR COMMENTS
ABOUT THIS CONCEPT?
DR. AIZER?
>> THANK YOU.
JUST A QUICK QUESTION ABOUT THIS
AS WELL AS I THINK IT ALSO
APPLIES TO THE FIRST CONCEPT.
THAT WAS INTRODUCED WHICH IS
SORT OF THE IDEA OF LOOKING AT
DETERMINANTS OF TAKE-UP OF
CONTRACEPTION USE AND WHETHER OR
NOT THAT WILL ALSO BE INCLUDED
AS PART OF THIS CONCEPT AND
RESEARCH PROGRAM.
>> THANK YOU FOR THAT FEEDBACK
OR KIND OF QUESTION ON WHETHER
OR NOT IT WILL BE INCLUDED.
WE'LL TAKE THAT INTO ACCOUNT
WHEN DESIGNING THE OUTCOMES, BUT
I THINK THAT THAT'S A GREAT
POINT, AND WOULD LIKELY BE
INCLUDED IN A NOTICE OF FUNDING
OPPORTUNITY.
>> THANKS.
>> DR. MORENO.
>> THANK YOU.
THIS SOUNDS LIKE A REALLY
EXCITING CONCEPT.
I WAS CURIOUS IF THERE WERE
SPECIFICS AROUND THINKING ABOUT
AGE RANGE OF TYPES OF
PARTICIPANTS THAT THIS APPROACH
MIGHT REACH.
FOR EXAMPLE, WHETHER IT WOULD
REACH OLDER CHILDREN OR YOUNGER
ADOLESCENTS AS WELL AS THROUGH
THE UPPER AGE RANGES.
>> SO PART OF THE CONTRACEPTION
RESEARCH BRANCH PROGRAMMATIC
PRIORITIES IS TO INCLUDE
ADOLESCENTS.
AS WAS MENTIONED KIND OF IN THE
PREAMBLE, WE TRY NOT TO GIVE
SPECIFICS.
BUT CERTAINLY OUR PRIORITY COVER
THE WIDE RANGE OF AGES FOR THOSE
USING CONTRACEPTION.
>> DR. VAN DEN VEYVER?
>> YES, I WOULD LIKE TO ASK IF
YOU WOULD ALSO INCLUDE OTHER
HORMONAL TREATMENTS THAT ARE
LIKE THE EXISTING
CONTRACEPTIVES, OR IS THIS GOING
TO BE FOCUSED ON EXISTING
MARKETED CONTRACEPTIVE AGENTS
USED FOR THIS PURPOSE?
>> CAN YOU GIVE ME AN EXAMPLE OF
WHAT YOU'RE TALKING ABOUT OTHER
THAN THE MARKETED HORMONAL
CONTRACEPTIVES?
>> I GUESS IS IT GOING TO SPAN A
WIDER NET IN CASE THERE IS A
NOVEL POTENTIAL FORMULATION
DEVELOPED THAT IS NOT CURRENTLY
ON THE MARKET MORE DEDICATED TO
THESE GYNECOLOGIC PATHOLOGIES?
>> SO WILL THE SCOPE GO BEYOND
CURRENTLY MARKETED
CONTRACEPTIVES?
WE CAN TAKE THAT INTO
CONSIDERATION.
I APPRECIATE THAT FEEDBACK.
BECAUSE THE LANGUAGE IN THIS WAS
MARKETED CONTRACEPTIVES.
>> THANK YOU.
I SEE THAT THERE IS A COMMENT
FROM DR. COLE HERE.
DR. COLE, DO YOU WANT TO JUST
COME OFF MUTE AND READ YOUR
QUESTION?
>> YES, I'VE HAD A CONVERSATION
WITH DR. BATES VIA THE CHAT, SO
I THINK WE'RE GOOD TO GO.
THANK YOU.
>> OKAY.
EXCELLENT.
ALL RIGHT.
WELL THEN, IF THERE ARE NO
FURTHER QUESTIONS OR COMMENTS,
LET ME ASK FOR A MOTION TO
APPROVE.
>> SO MOVED.
>> AND A SECOND?
ALL RIGHT.
AND ALL IN FAVOR?
>> WE HAVE SEVEN YESES.
>> OKAY, THANK YOU.
FINALLY, I'M GOING TO INTRODUCE
DR. MIN LEE FROM THE DIVISION OF
POPULATION HEALTH RESEARCH
DIVISION TO PRESENT THE
BIOLOGICAL TESTING FACILITY.
>> THANK YOU.
PROGRAM SEEKS COUNCIL APPROVAL
FOR A RECOMPETE OF AN INITIATIVE
TITLED BIOLOGICAL TESTING
FACILITY.
BTF.
THIS INITIATIVE SPANS BOTH DI R
AND D ER IN RESEARCH AND
DEVELOPMENT OF SAFE AND
EFFECTIVE CONTRACEPTION
REPRODUCTIVE HEALTH AND
THERAPEUTICS FOR WOMEN AND MEN.
IN THE UNITED STATES, NEARLY
HALF OF ALL PREGNANCIES ARE
UNINTENDED.
THIS RATE IS THE HIGHEST AMONG
DEVELOPED NATIONS.
THERE IS A CLEAR NEED FOR
ALTERNATIVE OR IMPROVED
CONTRACEPTIVE METHODS THAT MEET
THE REQUIREMENTS OF BOTH WOMEN
AND MEN.
THROUGHOUT THEIR
REPRODUCTIVE LIVES.
ADDITIONALLY, THERE'S A CRITICAL
NEED TO FACILITATE THE
DEVELOPMENT OF NEW REPRODUCTIVE
HEALTH-RELATED THERAPIES.
THE BTF WITH SEVERAL CYCLES OF
HISTORY FULFILLS A UNIQUE ROLE
IN BRIDGING THE DISCOVERY TO THE
DEVELOPMENT AND APPROVAL OF THE
CONTRACEPTIVE AND REPRODUCTIVE
HEALTH PRODUCTS.
THIS FACILITY PROVIDES IN VITRO
AND IN VIVO STUDIES THAT ARE
NEEDED AS PART OF A PRE-CLINICAL
DATA PACKAGE NECESSARY FOR FIL
FILING AN NIND.
THE BTF PROITS A PRE-CLINICAL
DATA FOR NUMEROUS PHASE ONE AND
PHASE TWO CLINICAL STUDIES AND
AN APPROVED DRUG
ULLIPISALACETATE.
THIS CLINICAL STUDIES CONDUCTED
BY OUR CONTRACEPTIVE CLINICAL
TRIALS NETWORK.
THE PRIMARY GOAL OF THIS
INITIATIVE IS TO DEVELOP NOVEL
AND IMPROVE METHODS OF
CONTRACEPTION WITH ADDITIONAL
INDICATIONS FOR REPRODUCTIVE
HEALTH AND THERAPEUTICS TO FILL
THE UNMET NEEDS.
THIS CONCEPT CLEARANCE IS IN
ALIGNMENT WITH NICHD STRATEGIC
PLAN THEME TWO IN PROMOTING
GYNECOLOGIC, ANDROLOGIC AND
REPRODUCTIVE HEALTH AND A
CONTRACEPTIVE DEVELOPMENT
PROGRAMS PRIORITY.
THANK YOU.
>> THANK YOU VERY MUCH.
ARE THERE ANY COMMENTS OR
QUESTIONS FOR DR. LEE?
NOT SEEING OR HEARING ANY, DO WE
HAVE A MOTION TO APPROVE THIS
CONCEPT?
>DO YOU HAVE A QUESTION?
>> I DO.
DO YOU HAVE A SENSE OF HOW MUCH
OF THIS WILL BE FOCUSED ON
CONTRACEPTION METHODS FOR MEN
VERSUS WOMEN?
JUST SORT OF READING THROUGH IT.
THERE SEEMS TO BE AT LEAST
PRELIMINARILY SLIGHTLY MORE
EMPHASIS ON MALE CONTRACEPTION.
>> NO, THIS IS NOT PURELY ON
MALE CONTRACEPTION.
THROUGH THIS PROGRAM, WE FUNDED
AND DID A LOT OF RESEARCH ON
WOMEN'S INJECTABLE WHICH WE ARE
CONTINUOUSLY DOING, SO AT THIS
POINT, YES, SO I THINK I WOULD
SAY RIGHT NOW, IT'S PROBABLY
HALF AND HALF.
I DON'T KNOW EXACT FUNDING BUT
THAT IS CURRENT THOUGHT.
>> SO IT WILL CONTINUE AT THAT
RATE, THAT BREAKDOWN?
>> NO, FOR US, WE'RE VERY
FLEXIBLE IN TERMS OF DOING A LOT
OF THE -- WORK AND THE
PRE-CLINICAL WORK.
SO IF WE ARE FACED WITH SOME
DIFFICULTY IN ONE AREA AND WE
NEED TO WAIT FOR CERTAIN DATA TO
COME BACK TO US, THEN WE CAN
PRIORITIZE ANOTHER PROGRAM OR
ANOTHER STUDY TO CONTINUE AND
WORK ON THAT ISSUE.
>> LET ME JUST REMIND YOU THAT
OF COURSE THIS IS A CONCEPT
RATHER THAN A DISCUSSION OF THE
EXACT WORK THAT WILL BE
SUPPORTED ON THE PROJECTS.
DR. CEDARS?
>> I WAS JUST CURIOUS, I THINK
THIS MAY HAVE BEEN RAISED AS A
CONCEPT AT THE SEPTEMBER
MEETING, AND I JUST -- IS THIS A
CONTINUATION OF THAT?
IS THIS A RENEWAL?
HOW IS THAT SORT OF -- SOME OF
THESE ARE NEW AND SOME SEEM LIKE
CONTINUATION.
I JUST WANTED TO CLARIFY.
>> O I SEE.
OKAY.
SO THANK YOU FOR THAT QUESTION.
QUESTION/COMMENT.
SO THE FIRST -- SEPTEMBER, WE
DID GET APPROVAL FOR THIS
CONCEPT, BUT WHAT WE WANTED TO
DO WAS CLARIFY THE FACT THAT
THIS ALSO INCLUDES REPRODUCTIVE
HEALTH.
AND WE WANTED TO MAKE CLEAR THAT
THIS CONCEPT HAS THAT LANGUAGE.
SO THIS IS THE REASON WHY WE'RE
PRESENTING THIS AGAIN.
THANK YOU.
>> OTHER COMMENTS OR QUESTIONS?
ALL RIGHT THEN.
CAN I HAVE A MOTION TO APPROVE?
>> SO MOVED.
>> AND A SECOND 70
>> SECOND.
70?
>> SECOND.
>> ALL IN FAVOR, PLEASE VOTE.
>> SEVEN YESES.
>> ALL RIGHT, THANK YOU.
AND JUST BEFORE WE MOVE ON, I
WONDER, DR. SAMEDY-BATES, IF YOU
COULD COME BACK ON FOR ONE
MOMENT.
MY COLLEAGUES POINT OUT THAT OF
COURSE NO ONE CAN SEE DR. COLE'S
COMMENTS IN THE CHAT IF THEY'RE
ON THE VIDEOCAST.
SO I'M JUST GOING TO READ OUT
HIS COMMENT, AND OF COURSE HE'S
WELCOME TO COME ON ALSO, AND IF
YOU JUST WANT TO TELL US, KIND
OF WHAT IT WAS YOU CHATTED ABOUT
WITH HIM AND THAT WAY IT WILL
BENEFIT WHOEVER WAS VIEWING.
SO WHAT DR. COLE WROTE WAS, WILL
C-PATH BE THE PRIMARY
COLLABORATIVE CONNECTION WITH
THE FDA AND WILL PHARMACEUTICAL
VENDORS BE INCLUDED?
AND IF YOU JUST WANTED TO
COMMENT BRIEFLY.
>> YES.
WHAT I HAD MENTIONED TO DR. COLE
WAS THAT MPRINT INVESTIGATORS
ARE IN COLLABORATIONS WITH
C-PATH, IN ADDITION TO SOME
OTHER COLLABORATIONS WITH FDA
BUT I DID WANT TO LET HIM KNOW
THAT WE ARE WORKING WITH C-PATH
AND HOPEFULLY WE PLAN TO BUILD A
STRONGER COLLABORATION WITH
VERSION 2.0.
ALSO MENTIONED THAT WE DON'T
YET -- WE HAVE NOT YET INCLUDED
PHARMACEUTICAL VENDORS BUT THIS
IS ALSO SOMETHING THAT WE COULD
POTENTIALLY THINK ABOUT FOR
MPRINT VERSION 2.0.
AND THEN ALSO JUST WANTED TO
MAKE EVERYONE AWARE OF MPRINT'S
ANNUAL MEETING, WHERE WE SHARE
MORE SPECIFIC INFORMATION FOR
THOSE THAT ARE INTERESTED, AND
THAT'S PUBLICLY AVAILABLE.
>> I WAS JUST TRYING TO MAKE THE
POINT THAT IN MY VERY LIMITED
EXPERIENCE WITH DRUG
DEVELOPMENT, THAT THE FDA IS AN
IMPORTANT PARTNER.
THE FDA HAS MANY DIFFERENT
PARTS.
SOMETIMES THE PARTS DO NOT
ALWAYS AGREE.
SO HAVING AN INTERNAL FDA
ADVOCATE MIGHT -- INVOLVED EARLY
ON IN THE PROCESS OR IN THE
PROCESS MIGHT BE A
CONSIDERATION, AND ALSO I THINK
ENGAGING POTENTIALLY INTERESTED
PHARMACEUTICAL COMPANIES,
ESPECIALLY WHEN THE FDA IS
PROVIDING INFORMATION FOR THOSE
COMPANIES, MIGHT BE A WAY OF
ACCELERATING IMPLEMENTATION OF
CLINICAL TRIALS.
THANK YOU VERY MUCH.
>> THANK YOU.
I SEE AARON POLLACK, WHO'S THE
CHIEF OF THIS BRANCH, WANTED TO
MAKE A COMMENT.
AARON?
>> THAT'S A FANTASTIC QUESTION
AND LINE OF THOUGHTS.
IN ADDITION TO WHAT LESLIE
MENTIONED, I DO WANT TO ADD A
LITTLE BIT MORE BROADLY ABOUT
INTERACTIONS THAT OBBTB HAS.
WE MEET WITH MULTIPLE OFFICES
WITHIN THE FDA TO DISCUSS
PEDIATRIC AS WELL AS MATERNAL
THERAPEUTIC AND DRUG
DEVELOPMENT, AND ACTUALLY WE DID
WORK WITH SEVERAL OF THEM SINCE
THEY ARE WITHIN THE FEDERAL
GOVERNMENT DURING THE
DEVELOPMENT OF THE RFAs FOR
MPRINT VERSION 1.
AND WE WILL, OF COURSE, REACH
OUT TO THEM FOR SOME INPUT.
WE OF COURSE CAN'T GET THAT
LEVEL OF INPUT FROM THE
PHARMACEUTICAL INDUSTRY, BUT I
ALSO DO WANT TO HIGHLIGHT THAT
THE BRANCH WORKS VERY CLOSELY
WITH THE FOUNDATION FOR THE NIH
AS WELL AS C-PATH IN TERMS -- AS
WELL AS ALSO THE NATIONAL
ACADEMY OF SCIENCE'S DRUG FORUM
IN TERMS OF SEEKING INPUT FROM
THE PHARMACEUTICAL SECTOR AND
COMPANIES THERE.
WE HAVE TO HANDLE THAT
APPROPRIATELY THROUGH GROUPS
SUCH AS THAT.
>> THAT'S GREAT.
THANK YOU VERY MUCH.
I THINK THE FNIH WOULD BE A
GREAT PARTNER AS WELL.
>> THANK YOU.
THIS WAS A GREAT DISCUSSION.
THANK YOU VERY, VERY MUCH.
DR. BIANCHI.
>> THANK YOU, DR. RASOOLY.
THROUGH ALL FOR YOUR
CONSIDERATION OF THE CONCEPTS.
WE ARE NOW GOING TO HEAR FROM
DR. THERESA CRUZ, DIRECTOR OF
THE NATIONAL CENTER FOR MEDICAL
REHABILITATION RESEARCH WHICH IS
HOUSED IN NICHD.
THE NCMRR IS PART OF NICHD AND
COORDINATES NIH MEDICAL
REHABILITATION RESEARCH.
EVERY FIVE YEARS, NCMRR IS
CHARGED WITH REVIEWING THE NIH
RESEARCH PLAN ON REHABILITATION.
THAT'S THE OVERALL NIH RESEARCH
PLAN.
DR. CRUZ IS GOING TO PRESENT
SOME OF THE HIGHLIGHTS OF THE
DRAFT 2025 PLAN TO YOU.
DR. CRUZ, OVER TO YOU.
>> THANK YOU, AND THANK YOU FOR
THE OPPORTUNITY TO TELL YOU A
LITTLE BIT ABOUT NCMRR.
WE HAVE SO MANY NEW
COUNCILMEMBERS.
SEVERAL ARE VERY FAMILIAR WITH
OUR WORK.
BUT MANY DO NOT KNOW WHO WE ARE.
SO I'M GOING TO TAKE A COUPLE
MINUTES, IF YOU COULD GO AHEAD
TO THE NEXT SLIDE AND ONE MORE.
TO TELL YOU A LITTLE BIT ABOUT
NCMRR.
WE WERE ESTABLISHED IN 1990.
A FEW MONTHS AFTER THE SIGNING
OF THE AMERICANS WITH
DISABILITIES ACT.
AND WE WERE CREATED TO BE A HOME
AT NIH TO CONDUCT AND SUPPORT
RESEARCH AND TRAINING ON THE
SCIENCE NEEDED TO SUPPORT PEOPLE
WITH PHYSICAL DISABILITIES.
AND WE'VE HAD A GREAT HOME AT
NICHD SINCE THEN.
SO HERE YOU CAN SEE IS OUR
MISSION TO SUPPORT THE
SCIENTIFIC KNOWLEDGE NEEDED TO
ENHANCE THE HEALTH,
PRODUCTIVITY, INDEPENDENCE AND
QUALITY OF LIFE FOR PEOPLE WITH
PHYSICAL DISABILITIES.
WE ALSO HAVE SPECIAL LANGUAGE
CALLING OUT THE SUPPORTIVE
PROSTHETICS AND ORTHOTICS
RESEARCH, FOR EXAMPLE.
WE ALSO HAVE LANGUAGE THAT
INSTRUCTS US TO COLLABORATE AND
COORDINATE WITH OTHER FEDERAL
AGENCIES AS WELL AS ACROSS NIH
IN SUPPORTING REHAB RESEARCH.
BUT WE OPERATE LARGELY LIKE A
DER BRANCH DIVISION OF
EXTRAMURAL RESEARCH BRANCH, SO
WE SUPPORT RESEARCH GRANTS,
TRAINING, CAREER DEVELOPMENT
ACTIVITY, SMALL BUSINESS, AND
INFRASTRUCTURE.
SO I MENTIONED WE WERE FOUNDED
IN 1990 BUT OUR LEGISLATION WAS
UPDATED IN 2016 WITH THE 21ST
CENTURY CURES ACT.
SO HERE WE WERE GIVEN A LITTLE
BIT MORE GUIDANCE ON OUR
ACTIVITIES.
SO WE HAVE TO REVISE AND PUBLISH
A RESEARCH PLAN EVERY FIVE
YEARS.
WE HAVE A COORDINATING COMMITTEE
THAT IS CHAIRED BY MYSELF AND
ANOTHER NIH INSTITUTE TO REPORT
OUT ON OUR PROGRESS OF THAT
RESEARCH PLAN.
WE ALSO HAVE AN ADVISORY BOARD,
WE HAVE A LIAISON BETWEEN THAT
ADVISORY BOARD AND THIS ADVISORY
BOARD.
OUR NEW MEMBER, DR. FIELD-FOTE
WAS A PREVIOUS CHAIR OF THAT
BOARD.
AND DR. DORN HAS THE PRIVILEGE
OF BEING ON BOTH AS WELL.
SO WE HAVE THESE GUIDANCE FROM
CONGRESS.
SO WHAT HAVE WE BEEN DOING
PREVIOUSLY?
WE HAD ESTABLISHED A RESEARCH
PLAN QUITE EARLY, 1993.
AND THEN IT HADN'T REALLY BEEN
UPDATED UNTIL 2016.
YOU'VE HEARD QUITE A BIT ABOUT
STRATEGIC PLANS TODAY.
NICHD STRATEGIC PLAN, NIAID
STRATEGIC PLAN.
AND SIMILAR RESEARCH PLAN
FOLLOWS THE SAME TYPE OF
PATTERN.
SO IN 2016, WE DEVELOPED THESE
SIX THEMES.
WE DECIDED TO REFRESH AND KEEP
THOSE SAME THEMES IN 2021.
THERE'S AN ANIMATION, I THINK.
MAYBE.
OKAY, THERE WE GO.
SO KIND OF KEEPING THE MAIN
THEMES BUT ADDING A LITTLE BIT
MORE ACTION TO THEM.
IN OUR 2021 VERSION.
SO WHEN WE STARTED THINKING
ABOUT WHAT KIND OF IMPACT DOES
HAVING A RESEARCH PLAN MAKE,
BECAUSE WE DON'T HAVE OUR OWN
APPROPRIATION, WE DON'T HAVE OUR
OWN BUDGET FROM CONGRESS, I
CAN'T SAY THAT THIS IS A CAUSAL
RELATIONSHIP.
BUT I DO THINK THAT HAVING A
RESEARCH PLAN OUT THERE WAS
HELPFUL IN GROWING THE
REHABILITATION PORTFOLIO AT NIH
AND YOU CAN SEE IT'S GONE FROM
ABOUT 500 MILLION TO OVER
900 MILLION.
AND THIS IS AN EXTRAMURAL
GRANTS.
THIS IS 10 TIMES WHAT NCMRR'S
BUDGET.
SO HAVING A RESEARCH PLAN THAT
HAS INVOLVEMENT OF ALL OF THE
NIH INSTITUTIONS THAT SUPPORT
REHAB IS REALLY IMPORTANT FOR US
TO GROW THIS FIELD.
SO WHAT ARE WE DOING IN 2025,
26?
SO IT TAKES A LONG TIME TO MAKE
A RESEARCH PLAN, TAKES A LONG
TIME TO DO A STRATEGIC PLAN, SO
WE STARTED ABOUT A YEAR AGO.
AND WE'VE BEEN WORKING QUITE
HARD ON IT.
AND IF WE GO TO THE NEXT SLIDE,
WE CAN TALK A LITTLE BIT MORE
ABOUT THE DETAILS.
SO THE FIRST THING WE DID WAS IN
FEBRUARY OF LAST YEAR, WE PUT
OUT A REQUEST FOR INFORMATION,
JUST TRYING TO GET A PULSE OF
THE FIELD ON HOW THEY WERE
THINKING ABOUT THE CURRENT
RESEARCH PLAN, WHAT SHOULD BE
RETAINED, WHAT SHOULD BE ADDED.
10 YEARS IS A LONG TIME IN
SCIENCE, SO HOW ARE WE DOING?
AND WE DISCUSSED THAT FEEDBACK
WITH OUR ADVISORY BOARD IN MAY.
THE NIH MEDICAL REHABILITATION
COORDINATING COMMITTEE IS A
GROUP OF ABOUT 25 TO 30 PROGRAM
OFFICERS FROM 20ICOs AFTER
NIH.
WE MEET MONTHLY.
I HAVE THE PRIVILEGE OF CHAIRING
THAT WITH A REPRESENTATIVE FROM
THE DEAFNESS AND OTHER
COMMUNICATION DISORDERS
INSTITUTE, NIDCD.
WE ROTATE THAT POSITION,
PREVIOUSLY AGING, NEUROLOGY,
NIAMS HAVE FILLED THAT ROLE WITH
THE NCMRR DIRECTOR.
SO WE TOOK THAT FEEDBACK AS WELL
AS OUR OWN INTERNAL ANALYSES AND
WE DRAFTED NEW THEMES OVER THE
SUMMER, JUNE THROUGH SEPTEMBER.
AND, TA DA, OKAY, WE'RE GOING TO
TALK A LITTLE BIT ABOUT WHAT
THOSE PROPOSED THEMES ARE.
I WOULD JUST HIGHLIGHT THAT
THESE ARE AREAS THAT WE THINK
ARE GOING TO SEE A LOT OF GROWTH
IN THE NEXT FIVE YEARS.
WE REALIZE THAT THEY MAY NOT BE
INCLUSIVE OF ALL REHAB RESEARCH,
BUT WHEN YOU THINK ABOUT WHERE
WE WERE 10 YEARS AGO TO WHERE WE
ARE NOW, WE THINK WE CAN BE A
LITTLE BIT MORE TARGETED IN THIS
RESEARCH PLAN.
AND THE MOST IMPORTANT THING IS
THAT PEOPLE WITH DISABILITIES
NEED TO BE THE CENTER OF ALL OF
THIS RESEARCH.
AND THEIR INPUT IS REQUIRED AT
ALL STAGES.
SO IF THAT DOESN'T EXPLICITLY
SAY IN EVERY SINGLE BULLET, KNOW
THAT THAT IS THE CORE PRINCIPLE
THAT GOES ACROSS ALL OF THESE
FIVE PROPOSED THEMES.
SO THE FIRST ONE INVOLVED BASIC
AND MECHANISTIC STUDIES.
SO HERE WE'RE REALLY TRYING TO
SEEK TO UNDERSTAND AND PREDICT
INDIVIDUAL RECOVERY FROM A
DISABLING DISEASE OR INJURY.
THERE'S STILL JUST A LOT OF
FOUNDATIONAL KNOWLEDGE THAT WE
NEED IN ORDER TO BETTER HELP
PEOPLE GET THE FUNCTION THEY
WOULD LIKE.
WE ALSO CONSIDER PRECISION REHAB
TO FALL UNDER THIS CATEGORY.
HOW CAN WE DEVELOP AND USE
BIOMARKERS TO TAILOR THE GUIDE
OF PRESCRIPTION REHAB
INTERVENTIONS.
THE SECOND THEME IS SOCIAL
DETERMINANTS OF HEALTH.
THE LAST FEW YEARS, WE'VE DONE A
LOT OF WORK LOOKING AT PEOPLE
WITH DISABILITIES A AS A
POPULATION THAT EXPERIENCES
HEALTH DISPARITIES.
WE'VE WORKED WITH NICHD TO MAKE
THAT CHANGE AT NIH AND WE'VE
BEEN REALLY CHAMPIONING THE
SCIENCE AROUND ABLEISM SO WE
THINK THAT'S A VERY IMPORTANT
ASPECT OF THE HEALTH FOR PEOPLE
WITH DISABILITIES.
AND THEN OF COURSE THERE'S ALSO
THE INTERSECTION OF MULTIPLE
IDENTITIES, SO HOW DOES HAVING
ANOTHER MINORITIZED IDENTITY
INFLUENCE A PERSON'S HEALTH,
WHAT ARE THE BARRIERS AND
FACILITATORS TO GETTING THE CARE
THEY NEED.
WE'RE ALSO INTERESTED IN WHERE
CARE IS DELIVERED.
WE KNOW THAT THERE'S DIFFERENT
OUTCOMES DEPENDING ON WHERE A
PERSON RECEIVES THEIR
REHABILITATION CARE.
AND THERE'S OPPORTUNITIES THERE
TO LEARN MORE.
THIRD, IS REHABILITATIVE AND
ASSISTIVE TECHNOLOGIES.
I MENTIONED EARLIER WE HAVE
SPECIFIC LEGISLATION THAT
DIRECTS US TO SUPPORT RESEARCH
IN THIS AREA, AND THE ROLE FOR
NIH IS KIND OF TWOFOLD.
WE SEE OURSELVES BEING VERY
IMPORTANT IN KIND OF EARLY STAGE
TECHNOLOGY DEVELOPMENT.
AND WE ALSO SEE A ROLE FOR
COMMERCIALIZATION SO USING THE
SMALL BUSINESS PROGRAM, NCMRR
SPENDS ABOUT 10 TO 12% OF OUR
BUDGET ON SMALL BUSINESS.
BECAUSE IT'S IMPORTANT THAT WE
GET THE TECHNOLOGIES OUT OF THE
LAB AND INTO PEOPLE'S HOMES OR
HOSPITALS OR WHEREVER THAT CARE
IS DELIVERED.
WE'VE ALSO HEARD A LOT TODAY
ABOUT THE IMPORTANCE OF
IMPLEMENTATION RESEARCH, AND
THIS IS AN AREA THAT WE ACTUALLY
HAVEN'T DONE AS MUCH AS WE THINK
WE COULD, AGAIN PUTTING THE
CONSUMERS OF REHAB AT THE FRONT
OF IT.
MAKING SURE THAT WE'RE
DEVELOPING THERAPIES THAT ARE
DESIRED, ACCEPTABLE,
COST-EFFICIENT AND EASY TO USE.
AND DEVELOPING THE EVIDENCE BASE
IN PRAGMATIC STUDIES TO MAKE
SURE THAT THE WORK THAT WE FIND
IN EFFICACY STUDIES TR TRANSLATS
TO THE REAL WORLD.
AND THEN OUR FINAL THEME,
TRAINING AND CAREER DEVELOPMENT
AND INFRASTRUCTURE, THOSE HAVE
ALL BEEN CORE TO WHAT NCMRR DO
DOES.
WE CONSIDER IT A SERVICE THAT WE
DO WHEN PEOPLE THAT WE HAVE
TRAINED GO AND GET R01s FROM
OTHER INSTITUTES AT NIH.
THAT IS PART OF OUR SUCCESS
STORIES.
SO WE ARE MAKING NEW INVE
INVESTMENTS.
WE'VE JUST REISSUED OUR K12
PROGRAMS WHICH WE'RE EXCITED TO
BRING BACK.
OUR INFRASTRUCTURE, YOU'LL BE
HEARING ABOUT THAT IN THE
MAY/JUNE COUNCIL MEETING.
SO WE'RE WELL ON OUR WAY IN
GETTING CAREER AND TRAINING
DEVELOPMENT NUMBERS BACK UP TO
WHERE WE THINK THEY SHOULD BE.
SO I'VE BEEN MAKING THE ROUNDS
WITH THESE THEMES.
WE TALKED TO A SUBCOMMITTEE OF
OUR ADVISORY BOARD, AND
PRESENTED TO OUR FULL BOARD IN
DECEMBER.
I WANT TO THE SHIRLEY RYAN
ABILITY LAB AND DID MORE ROUNDS
TO GET MORE FEEDBACK AND THEN I
PRESENTED A SPECIAL SECTION AT
THE AMERICAN CONGRESS OF REHAB
MEDICINE.
WORKING WITH COMMUNICATIONS TO
MAKE SURE THIS IS GOING TO BE A
PRETTY DOCUMENT, AND I WANT TO
THANK THEM FOR THEIR HELP.
SO WHERE DO WE GO FROM NOW?
HOPEFULLY IN A WEEK OR SO, WE'LL
HAVE A REQUEST FOR INFORMATION
OUT WITH THESE DRAFT THEMES TO
GET ONE MORE ROUND OF FEEDBACK
FROM THE WIDER COMMUNITY.
I'LL BE MEETING WITH THE GUY
SIF ITHE THEPHYSIATRISTS AT THEN
FEBRUARY.
WE'RE HOSTING OUR REHAB
CONFERENCE IN MARCH, YOU'RE ALL
INVITED, PLEASE JOIN US.
WE ARE VERY MUCH LOOKING FORWARD
TO HAVING OUR FIRST BIG IN
PERSON MEETING SINCE 2016.
OUR 2021 HAD TO BE MOVED TO
VIRTUAL, SO WE'RE EXCITED TO
BRING THAT BACK.
AND THEN WE WILL ALSO BE
PRESENTING A AT THE AMERICAN
SOCIETY OF NEURAL REHAB.
SO HAPPY TO TALK TO OTHER GROUPS
AS SUGGESTED.
AND GET THEIR INPUT ON THIS
BECAUSE REHAB IS QUITE
MULTIDISCIPLINARY.
AND WE NEED EVERYONE'S BUY-IN ON
IT.
SO JUST TO WRAP UP AS I SAID,
WE'RE PUTTING OUT THE REQUEST
FOR INFORMATION, WE'RE HOPING TO
GET OUR FINAL EDITS TO THOSE
THEMES IN APRIL AND GET
CONCURRENCE WITH THE THEMES AT
OUR MAY BOARD MEETING AND THEN
WE'LL GET OUR CLEARANCES, IT
GETS SUBMITTED TO BOTH THE
CONGRESS AND THE PRESIDENT.
IF YOU'RE INTERESTED IN KEEPING
UP WITH US, PLEASE JOIN OUR
LIST.
>> THANK YOU, THE QUESTIONS ARE
LINING UP HERE.
FIRST IS BONNIE.
>> SORRY.
I'M TRYING TO FIGURE OUT MY
CAMERA HERE.
OH, WELL.
I'LL JUST SPEAK WITH MY CAMERA
OFF.
THERE WE GO.
THANK YOU.
THAT WAS A WONDERFUL
PRESENTATION.
I JUST WANT TO HIGHLIGHT ONE
THING THAT YOU MAY ALREADY BE
AWARE OF BUT JUST FOR GENERAL
UNDERSTANDING, WE'VE DONE A
COUPLE OF SURVEYS WITH OUR
FACULTY AND OUR STAFF ACROSS NOT
JUST THE MEDICAL SCHOOL BUT THE
HOSPITALS, THE CHILDREN'S
HOSPITAL AND THE ADULT HOSPITAL.
WHETHER THEY IDENTIFY SPECIFIC
DISABILITIES AND THOSE ARE TWO
DIFFERENT THINGS.
ONE IS IDENTIFYING WITH AS BEING
DISABLED AND THE OTHER IS BEING
IDENTIFIED AS HAVING
DISABILITIES.
WHAT WE FOUND IS THAT 1 IN 4 TO
1 IN 5 PEOPLE IDENTIFIED AS
HAVING A SYMPTOM OR A DEFINED
DISABILITY, BUT THE PERCEPTION
OF BEING DISABLED WAS MUCH LOWER
THAN THAT.
SO I THINK THAT -- THERE'S OTHER
DATA AROUND HEALTH DISPARITIES,
OTHER THINGS ARE INCREDIBLY
IMPORTANT BUT I ALSO WANTED TO
POINT OUT THAT PEOPLE'S
PERCEPTION OF WHETHER THEY'RE
DISABLED OR NOT ARE ALSO VERY --
MAY NOT ALIGN WITH ACTUAL
DISABILITIES AND I THINK THE
ISSUE OF STIGMA OR OTHER
UNINTENDED BIASES OR UNINTENDED
FEELINGS OF NOT WANTING TO BE
CATEGORIZED IN A PARTICULAR WAY
REALLY DID SHOW UP IN THIS
SURVEY.
THIS IS JUST ONE INSTITUTION, SO
I HOPE THAT THIS IS SOMETHING
THAT CAN ALSO BE ADDRESSED IN
TERMS OF SOCIAL DETERMINANTS.
THIS IS AN IMPORTANT AREA AND
THESE ARE HEALTHCARE
PROFESSIONALS AND PEOPLE THAT
WORK IN THE HEALTHCARE SPACE WHO
DID NOT THEMSELVES IDENTIFY
WELL.
SO NOT GENERALIZABLE, BUT I
IMAGINE THAT THERE WOULD BE MORE
WORK TO BE DONE IN THAT AREA, SO
THANK YOU SO MUCH FOR YOUR WORK
IN THESE REALLY IMPORTANT TOPICS
AROUND REHABILITATION.
THANK YOU.
>> THANK YOU, BONNIE.
YOU HIT ON LIKE 20 THINGS THERE.
THE MEASUREMENT OF DISABILITY IS
A HUGE AREA THAT NEEDS MORE
WORK.
THERE'S QUITE A DISCUSSION WITH
CENSUS AND HOW THEY WERE
THINKING OF CHANGING HOW TO
MEASURE DISABILITY AND I FEEL
LIKE WE NEED TO DO A BETTER JOB
OF THAT AND I THINK THAT'S AN
OPPORTUNITY WHERE NIH COULD DO
MORE RESEARCH.
YOU BROUGHT UP STIGMA AND
SELF-REPORTING AND REASONS WHY
PEOPLE MAY OR MAY NOT FEEL
COMFORTABLE DOING THAT.
OUR DATA SHOWS THAT ONLY 1% OF
OUR PIs DISCLOSE HAVING OUR
PIs DISCLOSE A DISABILITY,
EITHER THEY'RE NOT FEELING
COMFORTABLE REPORTING OR WE'RE
NOT GETTING THEM INTO THE SYSTEM
SO WE'RE WORKING IN SEVERAL
AREAS TO TRY TO MAKE THAT KIND
OF A SAFER PLACE AND WE JUST
PUBLISHED A WEBPAGE ON RESOURCES
FOR PIs WITH DISABILITIES.
SO WE HEAR YOU AND WE'RE TRYING
TO ADDRESS THAT.
THANK YOU.
>> SESH?
>> THAT WAS A GREAT SET OF
INITIATIVES.
COMPLIEN CAL HOME IS THE
NEONATIVE INTENSIVE CARE UNIT,
AND WE HAVE RECOGNIZED RECENTLY
THE GREAT VALUE OF PRNM IN THE
NEONATIVE INTENSIVE CARE UNIT.
I WOULD JUST THROW OUT THE IDEA
THAT THERE IS A CRESCENDO OF
WHOLE GENOME SEQUENCING GOING ON
AMONG NICU BABIES.
SO THAT VENUE, PRNM,
NEONATOLOGISTS, GENOMICISTS
MIGHT BE AN INTERESTING AREA
WHERE PRECISION MEDICINE COULD
BE LINKED WITH IMPACT OF PRNM.
JUST A THOUGHT.
>> NO, THAT'S GREAT.
ACTUALLY ONE OF OUR R01
RESEARCHERS WAS TRAINED ON A K
AWARD THROUGH THE PREGNANCY AND
PERINATOLOGY BRANCH, AND SHE IS
NOW BRINGING THAT EXPERTISE
SPECIFIC TO CEREBRAL PALSY,
WHICH WE'RE NOW LURING HAS MANY
MORE GENETIC FACTORS AND CAUSES
TO BRING PMNR TO THE NICU.
>> ANYTHING YOU CAN DO TO INDUCE
INTEREST AMONG MY NEONATAL
COLLEAGUES, I THINK WOULD BE A
GOOD IDEA.
I'M HAPPY TO HELP WITH THAT.
>> THANK YOU, SESH.
EDE?
>> YOU'RE MUTED.
>> SORRY ABOUT THAT.
THOUGHT I HAD CLUCKE HAD CLICKE.
THANKS FOR YOUR GREAT
PRESENTATION, TERESA.
IT'S SO GREAT TO SEE YOU.
I NOTICED SOMETHING LAST WEEK AT
A WORKSHOP WHERE TOYEN WAS
PRESENTED, WHO IS A PROGRAM
OFFICER IN NCMRR, AND I NOTICED
FOR THE FIRST TIME THAT THE
NCMRR MISSION SPECIFICALLY SAYS
PHYSICAL DISABILITY, AND I HAD
NEVER NOTICED THAT BEFORE, AND I
LOOKED BACK THROUGH THE RESEARCH
PLAN AND I DIDN'T NOTICE -- I
DIDN'T NOTICE ANYWHERE IN THE
RESEARCH PLAN WHERE IT
SPECIFICALLY SAID PHYSICAL
DISABILITY AS OPPOSED TO THINGS
LIKE COGNITIVE DISABILITY,
HEARING DISABILITY, VISUAL
DISABILITY, AND I WONDER IF THAT
WAS SOMETHING NEW OR JUST -- IF
YOU COULD EXPAND ON THE FOCUS ON
PHYSICAL DISABILITY.
>> SO NCMRR'S LANGUAGE, OUR
CONGRESSIONAL LANGUAGE HAS
PHYSICAL IN IT.
BUT THE MEDICAL REHAB
COORDINATING COMMITTEE HAS
SENSORY, HAS COGNITIVE, HAS ALL
OF THOSE.
SO JUST THE NCMRR PART.
SO THAT HELPS US JUST KIND OF
DIVIDE UP THE WORK SO WE HAVE
OUR IDD BRANCH, THEY HAVE THE
INTELLECTUAL AND DEVELOPMENTAL
DISABILITIES, SO WE HAVE MORE OF
THE PHYSICAL.
BUT THIS IS SO TRANSDISCIPLINARY
AND WE CERTAINLY DO SUPPORT
COGNITIVE REHAB WHEN IT RELATES
TO SOMETHING LIKE TBI.
SO THAT HASN'T CHANGED.
>> THANK YOU.
>> AND ALSO THE LAST PART OF OUR
MISSION STATEMENT SAID OPTIMIZE
ABILITIES FOR ALL, SO THAT'S
MEANT TO ENCOMPASS BOTH PHYSICAL
DISABILITIES AS WELL AS
COGNITIVE AND OTHER POTENTIAL
DISABILITIES.
SO THANK YOU, TERESA, FOR THIS
REPORT AND FOR LEADING THE
CREATION OF THE NEW VERSION OF
THE NIH REHABILITATION RESEARCH
PLAN.
OKAY, COUNCIL, YOU'RE DOING
GREAT.
LAST PRESENTATION.
FINALLY THIS AFTERNOON WE'RE
GOING TO HEAR FROM DR. RONNA
POPKIN ABOUT THE NICHD TRY
ENYELL REPORT ON THE INCLUSION
OF WOMEN AND MINORITIES IN
CLINICAL RESEARCH.
AS YOU MAY KNOW, NIH IS MANDATED
BY LAW TO ENSURE THE APPROPRIATE
INCLUSION OF WOMEN AND MEMBERS
OF RACIAL AND ETHNIC MINORITY
GROUPS IN ALL NIH FUNDED
CLINICAL RESEARCH STUDIES.
SO THAT RESEARCH FINDINGS CAN BE
GENERALIZABLE TO THE ENTIRE
POPULATION.
A PART OF IMPLEMENTATION OF THIS
LAW AS PART OF IMPLEMENTATION OF
THIS LAW, NIH REQUIRES
INVESTIGATORS WHO CONDUCT
CLINICAL RESEARCH TO
REPORT ANNUALLY ON THE SEX OR
GENDER, RACE, AGE AND ETHNICITY
OF PARTICIPANTS.
EVERY THREE YEARS, NIH MUST
ASSEMBLE ALL OF ITS ENROLLMENT
DATA AND CREATE A TRIENNIAL
REPORT FOR CONGRESS.
RONNA IS NICHD'S INCLUSION
OFFICER, AND SHE WILL DESCRIBE
SOME OF THE HIGHLIGHTS OF THE
ANALYSIS OF NICHD ENROLLMENT
DATA FROM THE PAST THREE YEARS.
THE ENTIRE DRAFT NICHD REPORT
WAS INCLUDED IN YOUR COUNCIL
MATERIALS FOR YOUR
CONSIDERATION.
AFTER RONNA'S PRESENTATION, WE
WILL ASK COUNCIL TO VOTE ON
CONCURRENCE WITH THE REPORT.
I JUST WANT TO ACKNOWLEDGE THE
ENORMOUS AMOUNT OF WORK THIS
ENTAILED AND WE ARE GRATEFUL TO
RS
TO RONNA AND MANY OTHER PEOPLE.
SO OVER TO YOU.
>> THANK YOU SO MUCH.
>> NOW CAN EVERYONE HEAR ME
OKAY?
WONDERFUL.
ALL RIGHT.
THANK YOU SO MUCH, DR. BIANCHI.
WHILE I AM PERSON PRESENTING
HERE TODAY, I AM PRESENTING ON
BEHALF OF A MASSIVE TEAM, AND I
KNOW I AM LIKELY TO FORGET SOME
NAMES BUT I DO WANT TO TAKE A
MOMENT TO EXPLICITLY THANK HERE
AT NICHD SANDY DALCOR, CATHERINE
ADAMS, ANDREA MARCUS, LISA JATA,
KEITH RIVERS, JOE AGAINHART AND
SARAH GLAVIN ALL WHO HAVE WORKED
TIRELESSLY ON THIS REPORT IN
CONJUNCTION WITH ME, AND ALSO
OUR FOLKS IN THE NIH INCLUSION
OFFICE, REBECCA FABER AND DON
CORBETT.
SO YEAH, THIS IS A HERCULEAN
EFFORT SO THANKS TO EVERYBODY
FOR GETTING US TO WHERE WE ARE
RIGHT NOW.
BEFORE WE DIVE INTO THE DATA,
AND THE CHARTS IN THE REPORT, I
JUST WANT TO TAKE A MOMENT TO
STEP BACK AND TALK ABOUT WHY
THESE DATA MATTER.
SO ON THE SLIDE, WE SEE A
TIMELINE OF THE VARIOUS
INCLUSION POLICIES THAT HAVE
BEEN IMPLEMENTED ACROSS THE
YEARS AT NIH.
MOST OF THESE POLICIES HAVE
EMERGED BECAUSE CERTAIN
POPULATIONS IN THE U.S. WERE
EITHER BEING APPROPRIATELY
TARGETED FOR INCLUSION IN
RESEARCH OR SYSTEMATICALLY
EXCLUDED FROM RESEARCH.
SO THERE WERE STORIES OR STUDIES
THAT EMERGED, AND THESE POLICIES
EMERGED IN RESPONSE TO THAT.
AND SO REQUIRING APPROPRIATE
INCLUSION IS ONE OF THE THINGS
THAT ENSURES THAT WE ARE
SUPPORTING THAT STRONGEST AND
BEST SCIENCE POSSIBLE AT THE
NIH.
SO TODAY WHAT WE'RE GOING TO DO
IS FOCUS ON DATA IN RESPONSE TO
REALLY TWO OF THESE KEY
REQUIREMENTS.
THE 1994 POLICY THAT REQUIRED
INCLUSION OF WOMEN AND MEMBERS
OF RACIAL AND ETHNIC MINORITY
GROUPS, AND THEN THE MORE RECENT
2019 POLICY, THAT ALSO REQUIRED
INCLUSION OF INDIVIDUALS OF AGES
ACROSS THE LIFESPAN.
AND ONE THING TO NOTE IS THAT
FOR ALL OF THESE DEMOGRAPHIC
CATEGORIES, PEOPLE'S INCLUSION
IS REQUIRED UNLESS THERE ARE
VALID SCIENTIFIC OR ETHICAL
REASONS FOR THEIR EXCLUSION.
SO THIS IS RELEVANT ACTUALLY IN
RELATION TO SOME OF THE
QUESTIONS WE GOT EARLIER ON
CONCEPTS, LIKE ARE YOU GOING TO
INCLUDE ADOLESCENTS.
IF THE TOPIC IS RELEVANT TO
ADOLESCENTS, UNLESS THERE'S A
JUSTIFICATION FOR EXCLUDING THEM
FROM THE RESEARCH, THEY SHOULD
BE INCLUDED IN ANY KIND OF
PROPOSAL THAT SUBMITTED IN
RESPONSE TO ANY KIND OF FUNDING
OPPORTUNITY ANNOUNCEMENT.
SO THE CENTRAL GOAL OF OUR
INCLUSION POLICIES AT
DR. BIANCHI NOTED IS REALLY TO
MINIMIZE BIAS IN RESEARCH DESIGN
IN ORDER TO ENSURE THAT ALL
NIH-SUPPORTED CLINICAL RESEARCH
IS GENERALIZABLE TO THE BROADEST
POPULATION POSSIBLE.
SO THE GOAL IS NOT TO ACHIEVE
POPULATION REPRESENTATIVENESS IN
EVERY STUDY.
IN FACT, IN ORDER TO ACHIEVE OUR
SCIENTIFIC GOALS THAT WOULD
OFTEN NOT BE THE CASE.
BECAUSE WHAT IS SCIENTIFICALLY
AND ETHICALLY VALID AND
APPROPRIATE FOR RESEARCH IS
STUDY-SPECIFIC.
SO FOR EXAMPLE, IF A PROJECT IS
LOOKING TO STUDY DISPARITIES,
RACIAL OR ETHNIC DISPARITY, THEN
THAT MIGHT REQUIRE OVERSAMPLING
THOSE SMALLER MINORITY
POPULATIONS IN ORDER TO DRAW
VALID STATISTICAL CONCLUSIONS
ABOUT CERTAIN GROUPS.
SO IN ADDITION I WANT YOU TO
NOTE THAT THE POLICY LANGUAGE
ALSO APPLIES TO ALL CLINICAL
RESEARCH.
SO THAT DOESN'T MEAN CLINICAL
TRIALS.
NIH HAS A VERY BROAD DEFINITION
OF CLINICAL RESEARCH, AND IT YOU
INCLUDES ESSENTIALLY ALL
RESEARCH INVOLVING INTERACTIONS
WITH HUMAN SUBJECTS.
SO ANY HUMAN SUBJECTS RESEARCH
THAT IS NOT UTILIZING PREVIOUSLY
COLLECTED DATA.
AND I DO HAVE THE FULL FORMAL
DEFINITION OF CLINICAL RESEARCH
IF ANYBODY WANTS TO ASK ME ABOUT
IT LATER.
YOU A 'NOTHER THING I WANT YOU
ALL TO KEEP IN MIND AS WE REVIEW
THIS DATA IS THEY ARE
ADMINISTRATIVE DATA.
THESE ARE NOT ALL OF THE DATA
THAT THE RESEARCHERS COLLECT.
THIS IS JUST A SUBSAMPLE OF
THOSE DATA THAT WE ASK THEM TO
REPORT TO US TO ASSESS ADHERENCE
TO OUR POLICIES.
AND THE DATA THAT THEY REPORT TO
US ARE ONLY THEIR PROSPECTIVE
DATA.
SO IT DOES NOT INCLUDE ANY
EXISTING DATA THAT ANY OF OUR
INVESTIGATORS ARE ALREADY
WORKING AT.
SO IF THERE'S ONE THING THAT I
WANT YOU ALL TO WALK AWAY WITH
TODAY, IT IS THAT INCLUSION AT
NICHD IS ROBUST AND STRONGLY
ALIGNED WITH OUR MISSION AND
SCIENTIFIC PRIORITIES.
SO I'M GOING TO DEMONSTRATE THAT
WITH OUR UPCOMING CHARTS AND
TABLES AND WHAT I'M GOING TO
SHOW YOU IS A DEEPER DIVE INTO
SECTION 3 OF THE FULL REPORT.
WHICH IS THE ENROLLMENT DATA
ANALYSIS AND INTERPRETATION.
AND AS DR. BIANCHI SAID, THE
FULL REPORT IS AVAILABLE FOR YOU
TO READ AND WE DO WELCOME YOUR
FEEDBACK.
SO PLEASE, PLEASE SHARE THAT
WITH US.
SO NEXT BY LOOKING AT ENROLLMENT
BY SEX AN AND GENDER, A QUICK N,
THE CATEGORY REALLY IS SEX OR
GENDER.
SO PRINCIPAL INVESTIGATORS CAN
REPORT EITHER SEX DATA OR GENDER
DATA IN THAT ONE FIELD IN OUR
ENROLLMENT TABLES.
SO THIS CHART SHOWS A PROPORTION
OF MEN AND WOMEN ENROLL IN NICHD
CLINICAL RESEARCH IN EACH YEAR
OF THE REPORTING PERIOD.
AND WE SEE THAT WOMEN WERE A
MAJORITY OF NICHD PARTICIPANTS
BETWEEN 2022 AND 2024 RANGING
FROM BETWEEN 63% AND 73% OF
PARTICIPANTS ACROSS THE THREE
YEARS.
SO THE WOMEN ARE THE BLUE BARS
AT THE BOTTOM THAT ARE ALSO
POLKA DOTTED, AND THAT REFLECTS
NICHD'S RESEARCH PRIORITIES.
BECAUSE OUR PRIORITIES FOCUS ON
SEVERAL TOPICS THAT WOULD FOCUS
ON WOMEN'S HEALTH AND ON
MATERNAL HEALTH.
SO THAT WOULD REQUIRE A
DISPROPORTIONATE ENROLLMENT OF
WOMEN IN OUR STUDIES.
AND AS WOOR GOING TO SEE AS WE
MOVE INTO LOOKING AT ENROLLMENT
ACROSS RACE AND ETHNICITY, WHEN
WE LOOK AT THE INTERSECTION OF
SEX AND GENDER AND RACE AND
ETHNICITY, WE WILL FURTHER SEE
OUR SCIENTIFIC PRIORITIES
REFLECTED IN OUR ENROLLMENT
DATA.
SO BEFORE WITH WE LOOK AT THE
MINORITY DATA, I ALSO WANT TO
TAKE A MOMENT TO JUST EXPLAIN
THAT AS WE LOOK AT THE MINORITY
ENROLLMENT DATA, WE ARE ONLY
GOING TO BE LOOKING AT
ENROLLMENT IN U.S. SITES.
SO THE DATA THAT I JUST SHOWED
YOU ON SEX AND GENDER, THOSE
WERE FOR ENROLLMENT IN FOREIGN
AND DOMESTIC SITES.
BUT FOR MINORITY RACIAL AND
ETHNIC MINORITY DATA, WE LOOK
ONLY AT U.S. SITES AND THAT'S
BECAUSE RACE IS A SOCIAL
CATEGORY.
SO ITS MEANINGS AND ITS
RELATIONSHIPS TO HEALTH VARY
ACROSS TIME, CULTURE AND
COUNTRIES.
AND THE RACIAL AND ETHNIC
CATEGORIES THAT WE USE IN NIH
INCLUSION TABLE, THOSE ARE
U.S.-BASED RACE AND ETHNICITY
CATEGORIES.
SO THEIR MEANING AND THEIR
RELEVANCE TO RESEARCH, THAT'S
NOT STABLE ACROSS VARIOUS
SOCIOCULTURAL CONTEXTS.
SO FOR EXAMPLE, MANY OF THE
PARTICIPANTS IN CLINICAL
RESEARCH AT NON-U.S. SITES, THEY
WOULD BE CONSIDERED MEMBERS OF A
MINORITY RACIAL OR ETHNIC GROUP
IN THE U.S. BUT IN THEIR OWN
COUNTRY, THEY MIGHT BE A
MAJORITY GROUP AND IN ADDITION,
THEIR RACE OR ETHNICITY, THAT
MIGHT NOT BE THE OPERATIVE
SOCIAL CATEGORY ALONG WITH
ISSUES OF POWER INEQUALITY
CLEAVE.
SO THAT INCREASES THE STABILITY
OF THE MEANING OF THOSE
CATEGORIES AND THEREFORE THE
VALIDITY OF THE ANALYSIS OF OUR
INCLUSION PRACTICES.
SO IN THIS TABLE WE SEE RACIAL
AND ETHNIC MINORITY ENROLLMENT
IN NICHD CLINICAL RESEARCH AT
U.S. SITES ACROSS THE THREE-YEAR
PERIOD.
AND IT'S BROKEN DOWN IN THREE
DIFFERENT MINORITY ENROLLMENT
CATEGORIES.
THE SHADED COLUMN IS ALL
MINORITIES.
SO THAT INCLUDES RACIAL
MINORITIES AND WHITE HISPANICS
AND LATINOS, BECAUSE HISPANICS
AND LATINOS OF OTHER RACIAL
GROUPS WOULD ALREADY BE INCLUDED
IN THE RACIAL MINORITIES WHO ARE
IN THAT CATEGORY.
THEN THERE'S ALSO THE HISPANIC
LATINO COLUMN AND THEN JUST
RACIAL MINORITIES WHICH WOULD
INCLUDE RACIAL MINORITIES OF ANY
ETHNICITY.
AND SO ONE THING TO LOOK AT IS
WHEN YOU LOOK DOWN EACH COLUMN,
SO IN EACH RACIAL OR ETHNIC
MINORITY CATEGORY, THERE'S
REMARKABLE CONSISTENCY IN OUR
PERCENTAGE ENROLLMENT ACROSS
YEARS.
NOW IN ADDITION, IF YOU LOOK AT
THAT SHADED COLUMN, THE ALL
MINORITIES COLUMN, WE SEE THAT
AT NICHD, APPROXIMATELY HALF OF
ALL OF OUR CLINICAL RESEARCH
PARTICIPANTS AT U.S. SITES ARE
MINORITIES.
AND THEN IF WE LOOK AT THE
COLUMN ON THE RIGHT HAND, THE
FURTHEST RIGHT COLUMN, THE
RACIAL MINORITIES COLUMN, WE SEE
THAT JUST OVER A THIRD ARE
RACIAL MINORITIES.
NOW WHEN WE COMPARE THAT TO THE
REST OF MINORITY ENROLLMENT AT
NIH, WE SEE THAT THE LARGE
PERCENTAGES OF MINORITY
ENROLLMENT THAT WE HAVE AT NICHD
ARE NOT TYPICAL ACROSS ALL OTHER
INSTITUTES AND CENTERS.
SO IN THIS TABLE, WE'RE
COMPARING NICHD'S MINORITY
ENROLLMENT TO WHAT ENROLLMENT IS
AT NIH OVERALL.
AND WHEN WE SEE THAT NICHD'S
ENROLLMENT IN EVERY SINGLE
CATEGORY IS HIGHER THAN AT NIH
OVERALL, BUT ENROLLMENT OF ALL
MINORITIES AND RACIAL MINORITIES
IS ABOUT 50% HIGHER IN NICHD
CLINICAL RESEARCH.
THAT TOO REFLECTS OUR SCIENTIFIC
PRIOR ORTS WHICH INCLUDE MANY
PROGRAMMATIC AREAS THAT HAVE
LARGE RACIAL DISPARITIES
SPECIFICALLY.
SO MATERNAL MORBIDITY AND
MORTALITY.
UTERINE FIBROIDS, INFANT
MORTALITY.
I'M JUST NAMING A FEW.
THERE ARE MANY, MANY OTHERS.
SO THAT IS A REFLECTION OF OUR
PRIORITIES BUT IT IS ALSO A
REFLECTION OF THE HARD WORK OF
ENSURING THAT THAT ENROLLMENT IS
PRIORITIZED AND ACHIEVED.
AND THAT IS WORK THAT IS
UNDERTAKEN BY OUR INVESTIGATORS
AND OUR PROGRAM TO MAKE SURE
THAT THAT HAPPENS.
SO IT REFLECTS A LOT OF WORK.
AND I MENTIONED THAT IT'S
SPECIFICALLY RACIAL, THERE'S
RACIAL DISPARITIES SPECIFICALLY
AND THAT'S WHY WE WOULD EXPECT
TO SEE THE GREATEST KIND OF
OVERENROLLMENT IN THOSE
CATEGORIES AT NICHD.
SPECIFICALLY MANY OF THOSE
DISPARITIES ARE CONCENTRATED
AMONG AFRICAN AMERICAN AND BLACK
FOLKS IN THE UNITED STATES.
SO SO IF WE LOOK AT THIS BREAK
DOWN BY RACIAL GROUPS, AGAIN WE
SEE THIS REFLECTED IN OUR
ENROLLMENT DATA.
SO THIS SLIDE SHOWS YOU THE
BREAK DOWN OF RACIAL MINORITIES
AND WE SEE THAT THE
DISPROPORTIONATE ENROLLMENT
AMONG RACIAL MINORITIES IS
CONCENTRATED IN AFRICAN
AMERICANS.
AND IF I SHOWED YOU ANOTHER
SLIDE BUT WE DIDN'T HAVE TIME TO
GO THROUGH ALL THE CHARTS AND
TABLES TODAY BUT YOU'D SEE THAT
IT'S DISPROPORTIONATELY AFRICAN
AMERICAN WOMEN.
SO THIS ALL MAKES SENSE IN THE
CONTEXT OF OUR SCIENTIFIC
PRIORITIES AND OUR MISSION AND
WHAT TYPES OF SCIENCE AND THE
TOPIC AREAS HAVE BEEN HIGHEST
PRIORITY TO US OVER THE PAST
SEVERAL YEARS.
SO TOGETHER WHAT THESE SLIDES
SHOW IS THAT OUR INCLUSION IS
VERY STRONGLY ALIGNED WITH OUR
MISSION AND OUR SCIENCE.
STUDYING THESE TYPES OF
DISPARITIES, MATERNAL AND INFANT
MORTALITY, MATERNAL HEALTH
DISPARITIES, THAT REQUIRES THIS
KIND OF DISPROPORTIONATE
REPRESENTATION AND RESEARCH THAT
EVERYBODY HAS BEEN WORKING
REALLY HARD TO ACHIEVE AT NICHD.
SO FINALLY I WANT US TO TAKE A
LOOK AT INCLUSION ACROSS THE I
LIFESPAN BECAUSE THAT IS ALSO A
TOPIC THAT IS VERY IMPORTANT TO
US AT NICHD BECAUSE AFTER ALL WE
ARE THE INSTITUTE OF CHILD
HEALTH AND HUMAN DEVELOPMENT.
SO A COUPLE OF QUICK NOTES,
BECAUSE THE INCLUSION ACROSS THE
LIFESPAN POLICY WAS FIRST
IMPLEMENTED FOR ANY RESEARCH
APPLICATIONS THAT WERE SUBMITTED
IN JANUARY OF 2019, REPORTING ON
ENROLLMENT BY AGE REALLY DIDN'T
BEGIN, IT STARTED TO TRICKLE IN
IN 2021, REALLY STARTED TO PICK
UP IN 2022, BUT IT'S NOT REALLY
UNTIL 2024 THAT A MAJORITY OF
OUR STUDIES HAVE REQUIRED
REPORTING ON AGE AND ENROLLMENT.
SO I'M JUST SHOWING YOU THE 2024
DATA THIS YEAR IN OUR NEXT
TRIENNIAL REPORT WE'LL REALLY
HAVE MUCH MORE ROBUST AGE DATA.
IN THIS SLIDE, WHAT I'VE ALSO
DONE IS WE'RE COMPARING NICHD,
THE PIE CHART ON THE LEFT, TO
OTHER INSTITUTES AND CENTERS ON
THE RIGHT.
I HAVE EXPLICITLY PULLED NICHD'S
CHILDREN OUT OF THE OTHER NIH
DATA BECAUSE WE ENROLL SO MANY
OF THE CHILDREN IN RESEARCH
STUDIES AT NIH THAT I DIDN'T
WANT TO BE COMPARING US TO US.
I WANT TO BE COMPARING US TO THE
REST OF NIH.
NOT SURPRISINGLY, WE ENROLL MANY
MORE CHILDREN THAN THE REST OF
THE INSTITUTES AND CENTERS AT
THE NIH.
SO CHILDREN ARE THE BLUE PIE
CHART SO FROM APPROXIMATELY NOON
ON BOTH PIE CHART OVER, ON THE
NICHD PIE CHART, IT'S 34% SO
ABOUT A THIRD OF OUR
PARTICIPANTS ARE CHILDREN, AND
AT OTHER ICs, IT'S 9%.
SO WE ENROLL APPROXIMATELY FOUR
TIMES THE PERCENTAGE OF
CHILDREN.
AND AGAIN, NOT SO SURPRISINGLY,
WE ENROLL VERY FEW OLDER ADULTS.
THAT'S THE TINY LITTLE SLIVER OF
GREY COMPARED TO THE REST OF THE
NIH, WHICH ENROLLS ABOUT 16% OF
OLDER ADULTS.
BUT OUR MISSION IS TO DO
LIFECOURSE RESEARCH UP THROUGH
MIDDLE ADULTHOOD, RIGHT, IN
TERMS OF OUR PRIORITIES.
SO AGAIN, WE SEE THIS ALIGNMENT.
NOW ONE THING I REALLY WANT TO
HIGHLIGHT HERE, BECAUSE THIS IS
ALSO TAKEN -- HAS ALSO TAKEN A
LOT OF WORK BY OUR GRANTS
MANAGEMENT STAFF, OUR PROGRAM
STAFF, AND OUR INVESTIGATORS, IS
THE YELLOW PART OF THE PIE
CHART.
THE FINAL SLICE LEADING BACK UP
TO NOON.
ON BOTH SIDES.
AND NOTICE THAT FOR NICHD, IT'S
3%.
THAT IS PARTICIPANTS OF UNKNOWN
OR NOT REPORTED AGE, COMPARED TO
THE REST OF NIH, WHICH IS 29%.
SO COMPLIANCE WITH REPORTING OF
AGE IN THE INCLUSION ACROSS THE
LIFESPAN POLICY HAS BEEN A
CHALLENGE BECAUSE IT'S NEW.
PEOPLE HAVE BEEN REPORTING ON
ETHNICITY AND RACE AND SEX AND
GENDER FOR 30 YEARS AT THE NIH
BUT THE AGE REPORTING IS NEW AND
IT'S ALSO IN A NEW FORMAT AND
IT'S TAKEN A LOT OF WORK, AND SO
I THINK WE SHOULD BE REALLY
PROUD AT NICHD OF HOW WELL WE
HAVE DONE IN ENSURING COMPLIANCE
WITH THE REPORTING BY AGE.
IT'S REALLY REMARKABLE THAT OUR
UNKNOWN AND NOT REPORTED
PERCENTAGES ARE THAT LOW.
SO GREAT JOB, EVERYBODY.
BRAVO.
NEXT SLIDE, PLEASE.
AND OUR FINAL SLIDE ON AGE IS
JUST LOOKING AT AMONG THE
CHILDREN WHO ARE ENROLLED, SO
THIS IS ZOOMING IN ON THAT 34%,
AND THEN 9% OF CHILDREN WHO ARE
ENROLLED, DOES THE DISTRIBUTION
OF THOSE AGES LOOK DIFFERENT AT
NICHD VERSUS OTHER ICs AND THE
ANSWER IS YES.
WE ENROLL A MUCH GREATER
PROPORTION OF YOUNG CHILDREN AND
THE OTHER ICs ENROLL A GREATER
PROPORTION OF ADOLESCENTS.
SO IN 2024, AGAIN, THAT'S THE
SNAPSHOT HERE THAT WE'RE LOOKING
AT, 51% OF OUR PARTICIPANTS WERE
UNDER ONE YEAR, THAT HAPPENS TO
BE IN THAT YEAR BECAUSE THERE
WAS A NEW STUDY -- A NEW PROJECT
THAT BEGAN ON NEWBORN SCREENING,
BUT IN OTHER YEARS, IT'S STILL
QUITE HIGH COMPARED TO OTHER
ICs IF YOU LOOK AT THE
PARTICIPANTS 5 AND UNDER.
WE ENROLL A DISPROPORTIONATE
NUMBER OF THE PARTICIPANTS 5 AND
UNDER AT THE NIH.
SO IF YOU LOOK AT THIS, IT'S
ABOUT TWO THIRDS OF OUR
PARTICIPANTS ARE AGE 5 AND
UNDER.
66% IF YOU ADD THE 1 TO A AND 5D
THE UNDER 1 YEAR, COMPARED TO
21% AT THE OTHER ICs.
WHEREAS AT THE OTHER ICs,
ALMOST HALF OF THEIR
PARTICIPANTS ARE EITHER EARLY OR
LATER ADOLESCENTS COMPARED TO
JUST 15% OF THE CHILDREN
ENROLLED IN OUR RESEARCH.
SO JUST DIFFERENT AGES WHICH
MEANS AGAIN WE'RE FILLING
IMPORTANT SCIENTIFIC GAPS.
SO I'M NOT GOING TO TAKE TIME
BECAUSE WE'RE RUNNING SHORT ON
TIME HERE, I'M NOT GOING TO TAKE
TIME ABOUT THE LIMITATIONS.
I WANT TO HAVE THIS SLIDE HERE
IF ANYBODY WANTED TO TALK TO ME
ABOUT THESE.
THESE ARE SOME OF THE KEY
LIMITATIONS TO OUR INCLUSION
DATA AND I'M HAPPY TO CHAT WITH
FOLKS WI ABOUT THESE.
SO JUST IN CONCLUSION, I DO WANT
TO EMPHASIZE AGAIN, WE HAVE
REALLY EFFECTIVE INCLUSION
PRACTICES IN PLACE TO ENSURE
ADHERENCE WITH OUR POLICIES.
WE EXCEL IN INCLUDING WOMEN,
MINORITIES AND PEOPLE OF AGES
ACROSS THE LIFESPAN WITHIN OUR
MISSION, SO ESPECIALLY CHILDREN,
AND OUR DIVERSE ENROLLMENT IS
STRONGLY ALIGNED WITH THAT
MISSION AND PRIORITIES AND AGAIN
IF PEOPLE WANT TO CHAT WITH ME
ABOUT VISION AND FUTURE EFFORTS,
HAPPY TO DO THAT BUT I DO WANT
TO MENTION THAT MIDDLE BULLET.
APPROVING METRICS ACROSS THE
OTHER ICs FOR ASSESSING
INCLUSION.
SO WE ARE WORKING ON MANY OF THE
APPROPRIATE COMMITTEES ACROSS
NIH TO IMPROVE OUR INCLUSION
PRACTICES.
AND ONE OF THOSE THINGS THAT WE
HOPE TO DO OVER TIME AND THAT
WE'VE BEEN WORKING ON IS
COLLABORATING WITH THOSE
APPROPRIATE COMMITTEES TO
POTENTIALLY EXPAND OUR INCLUSION
AND WORK TOWARDS THINGS THAT ARE
MORE ALIGNED WITH OUR MISSION
LIKE INCLUSION OF FOLKS WITH
DISABILITIES AND INCLUSION OF
PREGNANT AND LACTATING PEOPLE.
BECAUSE THIS IS PART OF OUR
GOAL.
SO THANKS VERY MUCH.
HAPPY TO TAKE ANY QUESTIONS.
>> GREAT.
THANK YOU SO MUCH, RONNA.
I'M SURE THERE ARE QUESTIONS.
IT LOOKS LIKE KEN HAS A
QUESTION.
>> GREAT PRESENTATION.
REALLY, CONGRATULATIONS ON THE
NUMBERS BEATING OUT THE OTHER
ICs.
THAT'S FAN TAS TECH.
FANTASTIC WE CAN BE
COMPETITIVE.
I JUST WANTED TO OBSERVE THAT IN
JUST CIRCLING BACK TO SOME OF
THE EARLY COMMENTS ABOUT OUR
OPPORTUNITIES AND OUR CURRENT
WORK IN MATERNAL HEALTH, IN
PERINATAL HEALTH, IT WOULD BE
USEFUL TO KNOW WOMEN OF
REPRODUCTIVE AGE, AND I KNOW
THESE CATEGORIES ARE NOT EASY TO
DEFINE, I UNDERSTAND THAT, BUT
AS A REACH GOAL, IT WOULD BE
USEFUL TO KNOW THAT, AND ALSO
FOR THE KIDS, ALSO TO KNOW, THE
NEONATES.
>> AND IN MOST OF OUR RESEARCH,
BECAUSE AGE AT ENROLLMENT IS
REQUIRED OF PARTICIPANTS, WE
SHOULD BE ABLE TO HAVE THE DATA
BECAUSE IT'S A SPECIFIC YEAR OF
AGE, RIGHT?
IT'S NOT JUST A FIVE-YEAR AGE
SPAN OR ANYTHING LIKE THAT.
SO MOSTLY WE CAN GET A LOT OF
THAT DATA.
WHETHER PEOPLE ARE ACTUALLY
PREGNANT OR LACTATING, THAT'S A
DIFFERENT STORY.
THAT'S NOT SOMETHING WE'RE ABLE
TO DISCERN RIGHT NOW IN OUR
INCLUSION DATA AND THAT'S WHY
WE'RE SAYING THAT'S KIND OF A
VISION AND FUTURE GOAL.
BUT WHETHER THEY ARE OF REA
PRODUCTIVE AGE IS CERTAINLY
SOMETHING WE SHOULD, PER OUR
POLICIES, BE ABLE TO DETERMINE.
>> AND IF IT COULD BE COMPARED
TO THE OTHER INSTITUTES, IT
MIGHT BE INTERESTING.
>> YEAH.
OUR DATA, THESE DATA ARE MOSTLY
AGGREGATED, BUT WE MAY BE ABLE
TO GET MORE GRANULAR OVER TIME.
>> GREAT SUGGESTIONS, THANK YOU.
NEXT IS CYNTHIA.
>> YES, THANK YOU.
AND THANKS, RONNA, FOR THAT
REALLY WONDERFUL PRESENTATION.
I HAVE TO SAY, MY COMMENTS ARE
VERY SIMILAR TO THE PRIOR
COMMENTS.
MAYBE EVEN A STEP FURTHER.
I UNDERSTAND AT THE END OF YOUR
PRESENTATION, YOU MENTIONED
PREGNANCY IS A BIT OF A
CHALLENGE, BUT UNDERSTANDING THE
NUMBERS OF PREGNANT PEOPLE WHO
ARE INCLUDED IN CLINICAL TRIALS,
FOR ME AS A MATERNAL FETAL
MEDICINE PERSON IS SUPER
IMPORTANT, AND I JUST POINT TO
THE COVID VACCINE AS THE
PERENNIAL EXAMPLE OF WHERE
PREGNANT PEOPLE WERE
SYSTEMATICALLY EXCLUDED FROM
THOSE TRIALS AND AT THE SAME
TIME, WE HAD TO MAKE
RECOMMENDATIONS IN PREGNANCY ON
HOW TO USE THEM.
SO IF THERE IS ANY EFFORT
WHATSOEVER TO TRY TO IDENTIFY
PREGNANT PEOPLE AND MANDATE
THEIR INCLUSION IN CL CLINICAL
TRIALS WHERE IT'S APPROPRIATE,
WITH THE GUIDANCE OF NICHD'S
LEADERSHIP, I THINK THAT THAT
WOULD BE REALLY HELPFUL FOR ALL
OF YOU.
>> THANK YOU FOR THAT.
DR. BIANCHI, IF YOU WANT TO
SPEAK TO THAT.
I KNOW THIS HAS BEEN SOMETHING
THAT HAS BEEN REALLY IMPORTANT
TO OUR INSTITUTE AS A WHOLE.
AND IT IS CERTAINLY SOMETHING --
I SIT ON THE INCLUSION
GOVERNANCE COMMITTEE AT THE NIH
AND THIS IS SOMETHING THAT, YOU
KNOW, WE'VE BEEN BRINGING
FORWARD.
DR. AARON POLLACK WHO WAS JUST
SPEAKING, THIS IS SOMETHING THAT
HE'S BEEN REALLY WORKING ON
WITHIN HIS BRANCH, DR. THERESA
CRUZ HAS BEEN WORKING ON THE
DISABILITY PIECE SO THERE'S A
LOT OF COORDINATION AND EFFORT
WITHIN OUR INSTITUTE TO BRING
THIS TO NIH AS A WHOLE AND TO
HOPE TO MOVE THE NEEDLE ON THESE
FRONTS.
THANK YOU.
>> I THINK THE DATA SPEAK FOR
THEMSELVES.
I MEAN, IT'S REALLY REMARKABLE
COMPARED TO OTHER INSTITUTES AND
CENTERS, THE DIFFERENCE.
AND I KNOW THAT CERTAINLY IN THE
INTRAMURAL PROGRAMS, IT'S
PROBABLY EVEN MORE DRAMATIC
BECAUSE THE CLINICAL CENTER,
FIRST OF ALL, IN GENERAL,
CHILDREN UNDER AGE 2 CANNOT BE
ON PROTOCOL IN THE CLINICAL
CENTER, BUT ALSO STUDYING
PREGNANT PEOPLE IN A PRIMARY
PROTOCOL, PEOPLE WHO ARE
PREGNANT AND THEY'RE REQUIRED TO
BE PREGNANT AS PART OF THE
ENROLLMENT CRITERIA IS STILL IN
THE DARK AGES IN THE CLINICAL
CENTER.
WHEREAS THEY WILL ACCOMMODATE
PEOPLE, FOR EXAMPLE, WHO ARE
BEING TREATED FOR CANCER AS THE
PRIMARY ISSUE BUT WHO HAPPEN TO
BE PREGNANT.
SO I THINK WE HAVE A LONG WAY TO
GO TO CHANGE THE CULTURE.
THERE ARE ALREADY SOME IMPORTANT
CHANGES AND THERE'S PROGRESS
BEING MADE, BUT WE STILL HAVE A
LONG WAY TO GO.
>> I THINK, IGNA, YOU HAD A
QUESTION, BUT YOU TOOK YOUR HAND
DOWN.
>> YEAH, I DIDN'T WANT TO BE
RUDE AND TURN MY CAMERA OFF BUT
ACTUALLY THEY WERE VERY MUCH
OVERLAPPING WITH THE OTHER
QUESTIONS THAT WERE ALREADY
ASKED, SO.
>> OKAY.
WELL, RONNA, THIS WAS FANTASTIC,
THE REPORT IS REALLY IMPORTANT.
THANK YOU FOR LEADING THE
ANALYSIS AND THE -- DESCRIBING
IT AND ADVOCATING FOR MORE
INCLUSION NIH-WIDE.
SO IS THERE ANY FURTHER
DISCUSSION?
YOU'RE GETTING A LOT OF CU KUDON
THE CHAT BOX, BY THE WAY, FROM
YOUR COLLEAGUES.
IF NOT, MAY I HAVE A MOTION FOR
APPROVAL OF THE NICHD TRIENNIAL
REPORT?
>> MOTION TO APPROVE.
>> THANK YOU, CYNTHIA.
AND DO WE HAVE A SECOND?
>> SECOND.
>> THANK YOU, MARCELLE.
PLEASE VOTE WITH YOUR LITTLE
CHECKMARKS.
>> YOU HAVE SEVEN YES VOTES.
>> OKAY.
SO THE MOTION IS APPROVED.
AND REMARKABLY, WE ARE ON TIME.
IT'S ALWAYS INTERESTING HOW THE
COUNCIL PLAYS OUT.
I WANT TO THANK YOU ALL IN YOUR
VARIOUS TIME ZONES FOR YOUR
ATTENTION AND YOUR ENGAGEMENT
AND THE FACT THAT YOU'VE ASKED
SUCH GREAT QUESTIONS.
THIS CONCLUDES THE FIRST DAY OF
OUR TWO-DAY NICHD ADVISORY
COUNCIL MEETING.
THANK YOU ALL FOR ATTENDING, AND
THAT INCLUDES MEMBERS OF THE
PUBLIC AND ADVOCACY GROUPS WHO
HAVE BEEN LISTENING IN.
WE LACK FORWAR LOOK FORWARD TO G
EVERYONE TOMORROW AT 9:00 A.M.
FOR OUR CLOSED SESSION.
AGAIN, UNLIKE TODAY, THE START
TIME WILL BE 9:00 A.M. EASTERN
STANDARD TIME.
HAVE A GREAT EVENING, EVERYONE,
AND WE'LL SEE THE COUNCILMEMBERS
TOMORROW.
THANK YOU.