>> WELL, THANK YOU.
GOOD MORNING AND WELCOME TO THE
185th 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 WE'LL HOLD
AN OPEN SESSION FROM 8:30 A.M.
TO 9:15 AND THEN CONVENE OUR
CLOSED SESSION.
IT'S GREAT TO HAVE ALL OF OUR
COUNCIL MEMBERS HERE IN PERSON
AND SO MANY STAFF MEMBERS.
I THINK THIS IS THE BIGGEST
AUDIENCE SINCE BEFORE THE
PANDEMIC.
SO THANK YOU ALL FOR COMING AND
I KNOW MANY OF OUR COUNCIL
MEMBERS HAVE COME ACROSS THE
ATLANTIC OCEAN OR ACROSS OUR
COUNTRY SO WE REALLY APPRECIATE
ALL OF YOU HAVE JOINED US.
AND WE ALSO APPRECIATE PEOPLE
WHO ARE WATCHING US ON THE
VIDEOCAST.
WITH US FOR THE FIRST TIME AS
MEMBERS OF THE COUNCIL TODAY NEW
MEMBERS.
I WOULD KNOW LIKE TO CALL EACH
TO BRIEFLY INTRODUCE THEMSELVES.
CYNTHIA PLEASE START.
>> I AM A MATERNAL FETAL
MEDICINE SPECIALIST.
>> GOOD MORNING I'M A CIVILIAN
DEPUTY DIRECTOR AND
CONGRESSIONAL DIRECTED MEDICAL
RESEARCH PROGRAMS PART OF THE
DEPARTMENT OF DEFENSE.
WE OFFER DIFFERENT FUNDING
OPPORTUNITIES FOR CONGRESSIONAL
DIRECTED TOPICS FROM CANCERS AND
MEDICINES.
HAPPY TO BE HERE.
>> THANK YOU SO MUCH.
WITH THE HYBRID MEETING FORMAT
THOSE JOINING VIA ZOOM REMEMBER
TO UNMUTE YOURSELF BEFORE
SPEAKING IN YOU'RE MICROPHONE
AND STATE YOUR NAME SO THE
TRANSCRIBER AND VIDEOCAST
OBSERVERS WILL KNOW WHO IS
SPEAKING.
AFTER YOU SPEAK, PLEASE BE SURE
TO MUTE YOUR MICROPHONE NORD IN
ORDER TO PREVENT FEEDBACK LOOPS
AND AUDITORY INTERFERENCES.
NOW OVER TO DR. REBEKAH RASOOLY
THE DIRECTOR OF EXTRAMURAL
ACTIVITIES.
>> GOOD MORNING.
OUR COUNCIL MEMBER WEBSITE YOU
SHOULD HAVE READ AND SIGNED THE
CONFIDENTIALITY AND NON
DISCLOSURE RULES FOR REVIEWING
NIH GRANT APPLICATIONS.
REMEMBER, YOU CANNOT SERVE AS A
COUNCIL MEMBER ON ANY NIH
PEER-REVIEW PANEL WHILE YOU ARE
A COUNCIL MEMBER.
AND YOU CANNOT PROVIDE
SECOND-LEVEL REVIEW FOR ANY
APPLICATION FOR WHICH YOU
PARTICIPATE IN IN THE FIRST
LEVEL OF PEER REVIEW IT'S NIH'S
POLICY AN INDIVIDUAL CANNOT
SERVE ON THE FIRST AND SECOND
LEVELS OF REVIEW.
NOW, I DID WANT TO ALSO BRING TO
YOUR ATTENTION THAT TOMORROW
DURING THE CLOSED SESSION WITH A
LITTLE REVIEW MORE POLICIES AND
CONFIDENTIALITY AND
NON-DISCLOSURE AND PLEASE SHOW
CLOUD-BASED VOICED SERVICES AT
HOME OR OFFICE SUCH AS ALEXA
DEVICES AS THEY MAY BE ABLE TO
CAPTURE CONFIDENTIAL
INFORMATION.
WE'LL NOW TURN ATTENTION TO THE
MINUTES.
FOR THE JANUARY 23, 2024 MEETING
WERE POSTED ON THE COUNCIL
MEMBER WEBSITE AND WILL BE
POSTED ON THE NICHD PUBLIC
COUNCIL SITE ONCE THEY ARE
APPROVED.
SO I'M GOING TO ASK NOW FOR A
VOTE TO APPROVE THE MINUTES.
IN ORDER TO VOTE, PLEASE RAISE
YOUR HAND IF YOU'RE IN THE ROOM
AND FOR THOSE ON ZOOM, IF YOU'RE
VOTING, GO TO THE REACTIONS
BUTTON AT THE BOTTOM OF YOUR
SCREEN AND AFTER CHOOSING THAT
YOU CAN CHOOSE EITHER THE GREEN
CIRCLE WITH THE CHECK ON IT FOR
YES OR RED CIRCLE WITH AN X FOR
NO OR RAISED HAND FOR ABSTAIN.
MAY I HAVE I AMOTION TO APPROVE
THE JANUARY MINUTES?
>> MOVE TO APPROVE.
>> SECOND.
>> THANK YOU.
ALL IN FAVOR.
AND ANY OPPOSED?
THANK YOU SO MUCH.
FINALLY, BEFORE MOVING INTO THE
MEETING, I WANTED TO REVIEW WITH
YOU THE FUTURE MEETING DATES.
WE LOOK FORWARD TO BEING
TOGETHER IN PERSON SEPTEMBER ON
THE 4th AND 5th.
ON THE FIRST DAY OF THE MEET,
SEPTEMBER 4 WE'LL BE ON THE NIH
CAMPUS.
THE REASON IS WE'D LIKE YOU TO
TAKE A TOUR OF OUR EXTRAMURAL
FACILITIES.
THAT SEPTEMBER MEETING IS WHERE
THE INTRAMURAL HAS A SPECIAL
FOCUS AND THE SECOND DAY WE'LL
BE IN THE MEETING AND JANUARY
VIRTUALLY AND THE REST OF THE
DATES YOU CAN SEE AS LISTED ON
THE CALENDAR.
I'LL NOW TURN IT BACK TO
DR. BIANCHI.
>> THANK YOU.
CAN WE HAVE SLIDES UP, PLEASE.
>> THERE'S A LOT HAPPEN AS YOU
CAN SEE BY THE EXTENSIVE TALK
OUTLINE.
TODAY I'LL COVER THE FISCAL YEAR
'25 BUDGET.
WE'RE WELL INTO THE '24 BUDGET
AND WE'VE BEEN VERY BUSY WITH
CONGRESSIONAL INTERACTIONS.
WE'LL TALK ABOUT OUR RESEARCH
PORTFOLIO FOR SOME NEW MEMBERS
HERE FOR THE FIRST TIME AS WELL
AS OUR NEW REFRESH OF THE
STRATEGIC PLANNING EFFORT.
A LOT OF OUR ACTIVITIES ARE
RELATED TO WOMEN'S HEALTH AND
YOU'LL HEAR ABOUT THE WOMEN'S
HEALTH RESEARCH INITIATIVE FROM
THE WHITE HOUSE.
OUR ACTIVITIES IN ENDRIGHTRY --
ENDOMEETRIOSIS AND TALK ABOUT
PEDIATRICS IN THE ALL OF US
PROGRAM, WE'LL TALK ABOUT
MEDICAL DEVICES AS WELL AS OTHER
UPDATES ON CENTRAL KEY NIH
PROGRAMS AND POLICIES WE DIDN'T
TALK ABOUT THE LAST COUNCIL.
WE WILL CONGRATULATE ONE OF OUR
EXTRAMURAL PROGRAM MEMBERS AND
THEN GET TO STAFF UPDATES.
AND WE'LL LEAVE TIME FOR
QUESTIONS.
NOW, THE PRESIDENT CAN COMPOSE
THE BUDGET BUT IT'S CONGRESS WHO
APPROPRIATES SO DON'T GET TOO
EXCITED ABOUT THE FISCAL YEAR
'25 PRESIDENT'S BUDGET.
THIS IS WHAT HE WOULD LIKE TO
HAVE BUT OF COURSE CONGRESS HAS
TO AGREE TO IT.
HE IS PROPOSING A $50.1 BILLION
THAT WOULD BE A SEVERAL BILLION
DOLLAR INCREASE.
WITH A SLIGHT INCREASE FOR
NICHD.
WE'RE ALMOST AT $1.76 BILLION
NOW.
HE WOULD BE PROPOSING ANOTHER
BILLION.
IN WOMEN'S HEALTH RESEARCH, HE'S
PROPOSING A NEW NATIONWIDE
NETWORK OF CENTERS OF EXCELLENCE
AND INNOVATION IN WOMEN'S HEALTH
AND HE'S PROPOSING TO DOUBLE THE
OFFICE OF RESEARCH ON WOMEN'S
HEALTH AT NIH.
THE HOUSE APPROPRIATION
SUBCOMMITTEE THAT COVERS THE NIH
BUDGET IS NOT GOING TO HAVE IT
THIS YEAR BUT ON MAY 23 THERE
WERE SEVEN APPROPRIATION
HEARINGS.
NICHD DID NOT PRESENT AT THAT
MEETING BUT A NUMBER OF TOPICS
THAT CAME UP RELATED TO OUR
INTERESTS WERE RAISED AND IT WAS
A POSITIVE HEARING.
A NUMBER OF OUR COLLEAGUES AS
WELL AS DR. BERTAGNOLLI OUR
DIRECTOR FOR HER FIRST SENATE
HEARING SINCE BECOMING DIRECTOR
AND WAS OVER ALL VERY WELL
RECEIVED.
NOW, I MENTIONED WE'VE BEEN VERY
BUSY WITH CONGRESSIONAL
INTERACTIONS IN THE UPPER LEFT
PHOTO IS REPRESENTATIVE LAUREN
UNDERWOOD OF ILLINOIS.
SHE IS AN INCREDIBLE CHAMPION
FOR WOMEN'S HEALTH RELATED
RESEARCH.
SHE'S BEEN THE CHAMPION BEHIND
THE IMPROVE INITIATIVE BECAUSE
MENOPAUSE IS MENTIONED IN THE
PRESIDENT'S EXECUTIVE ORDER ON
WOMEN'S HEALTH RESEARCH, SHE HAD
A VIRTUAL BRIEFING WITH US ON
MENOPAUSE AND WE'RE ABOUT TO
MEET WITH HER IN THE NEXT COUPLE
OF WEEKS AGAIN ON AN UPDATE ON
THE IMPROVE INITIATIVE.
THE MIDDLE PICTURE, I HAD THE
PLEASURE OF MEETING
REPRESENTATIVE LETLOW FROM A
MATERNITY CARE DESERT AREA IN
LOUISIANA INTERESTED IN MATERNAL
HEALTH AND WOMEN'S HEALTH
RESEARCH.
I ALSO SPOKE AT THE WOMEN'S
CONGRESSIONAL POLICY INSTITUTE.
THERE WERE TWO MEMBERS THERE
REPRESENTATIVE ROBIN KELLY AND
CHAPOWSKI IN ILLINOIS INTERESTED
IN MATERNAL MORTALITY AND WHAT
WE CAN DO TO REDUCE MATERNAL
MORTALITY.
THE ACT FOR NIH IS A FOUNDATION
THAT WORKS WITH CONGRESS TO
SUPPORT NIH AND INFECTIOUS THE
BUDGET.
THE LOWER RIGHT PICTURE THERE
THE WOMEN ON THE LEFT THE PURPLE
HAIR AND WE SEE THE RANKING
MEMBER ON THE HOUSE SUBCOMMITTEE
ON LABOR HHS SO SHE'S ALWAYS
BEEN VERY INVOLVED IN OUR
BUDGET.
VERY SUPPORTIVE OF NICHD'S
INTEREST.
ANY TIME SHE HAS HER HANDS ON MY
SHOULDER IT'S A GOOD DAY.
NEXT TO ME IS DR. TUCCI FROM THE
NATIONAL INSTITUTE OF DEAFNESS
AND COMMUNICATION DISORDERS.
IT'S A WONDERFUL EVENT.
THERE WERE WELL OVER 20 MEMBER
OF CONGRESS.
AGAIN, A VERY POSITIVE
INTERACTION.
THEN LASTLY IN THE UPPER RIGHT
TO THE RIGHT OF ME IS
REPRESENTATIVE NIKEMA WILLIAMS
FROM THE ATLANTA AREA AND WAS
RE-INTRODUCING THE ENDOMETRIOSIS
CARES ACT.
THERE WAS AN EVENT AT THE
CAPITAL AND WE MET A NUMBER OF
WOMEN'S WHO ARE ADVOCATES AND
ALSO PERSONALLY AFFECTED BY
ENDOMETRIOSIS.
IT'S BEEN A BUSY COUPLE OF
MONTHS.
OUR STAFF HAVE HAD BRIEFINGS
WITH THE STAFF OF OTHER MEMBERS
INCLUDING REPRESENTATIVE
CISCOMANI AND REPRESENT CLARK
AND REPRESENTATIVE ESHOO AND
REPRESENTATIVE SCOTT AND THEY'RE
ALL INTERESTED IN SPECIFIC AREAS
OF OUR PORTFOLIO EITHER MATERNAL
AND/OR CHILD HEALTH.
SO AGAIN FOR PEOPLE HERE FOR THE
FIRST TIME JUST TO REMIND YOU,
WHAT IS OUR PORTFOLIO?
OF COURSE, WE'RE NAMED FOR
EUNICE KENNEDY SHRIVER ON THE
LEFT THE SISTER OF PRESIDENT
KENNEDY WHOSE IDEA IT WAS TO
HAVE A SEPARATE INSTITUTE AS IT
SAYS ON THE ORIGINAL
LEGISLATION, MATERNAL AND HUMAN
HEALTH AND DEVELOPMENT.
OUR PORTFOLIO IS ABOUT 55%
PEDIATRICS, 30% REPRODUCTIVE
HEALTH EVERYTHING FROM THE
DEVELOPMENT OF REPRODUCTIVE
ORGANS TO CONTRACEPTION TO
PREGNANCY TO POSTPARTUM ALL THE
WAY UP UNTIL EARLY AND INCLUDING
EARLY MENOPAUSE.
EARLY MENOPAUSE IS ABOUT THE AGE
OF 45 AND WE HAVE A STAKE IN
THAT AS WELL.
AND 15% OF OUR PORTFOLIO PARTLY
THROUGH THE NATIONAL CENTER FOR
MEDICAL REHABILITATION RESEARCH
IS IN INTELLECTUAL,
DEVELOPMENTAL DISABILITIES AND
PHYSICAL REHABILITATION
INCLUDING ADULTS SO SOME PEOPLE
ARE SURPRISED WHEN I SAID YES,
WE TO RESEARCH ON ADULTS.
AND TO BRING IT FULL CIRCLE ON
THE RIGHT YOU SEE MARIA SHRIVER
AND SERGEANT SHRIVER'S FOUR
CHILDREN AND TIM WAS A FORMER
MEMBER OF OUR ADVISORY COUNCIL
AND MARIA IS VERY ACTIVE IN THE
WOMEN'S HEALTH RESEARCH
INSTITUTE.
SO WE CONTINUE OUR CONNECTION
WITH THE SHRIVER FAMILY TO THIS
DAY.
SO IN 2020, OUR STAFF THE STAFF
WHO WERE AROUND IN 2019, 2020,
WE FINALIZED OUR STRATEGIC PLAN
WHICH WAS RID OF BY THE 21st
CENTURY'S CURE ACT BUT WAS A
NECESSITY SINCE WE DIDN'T HAVE A
STRATEGIC PLAN PRIOR TO 2000.
WE HAVE FIVE THEMES AND THOSE
SERVED ON COUNCIL NOW A NUMBER
OF YEARS KNOW THE FIVE THEMES
BECAUSE WE ENCOURAGE OUR PROGRAM
OFFICIALS TO CONNECT INITIATIVES
TO OUR STRATEGIC PLAN AND THESE
INCLUDE UNDERSTANDING THE
MOLECULAR, CELLULAR AND
STRUCTURAL BASIS OF DEVELOPMENT,
PROMOTING GYNECOLOGIC AND
REPRODUCTIVE HEALTH, SETTING THE
FOUNDATION FOR HEALTHY
PREGNANCIES AND LIFE LONG
WELLNESS.
IMPROVING CHILD AND ADOLESCENT
HEALTH AND THE TRANSITION TO
ADULTHOOD AND ADVANCING SAFE AND
EFFECTIVE THERAPEUTICS AN
DEVICES FOR PREGNANT AND
LACTATING WOMEN, CHILDREN AND
PEOPLE WITH DISABILITIES.
AND I THINK THE LAST FIVE YEARS
WE'VE MADE AN ENORMOUS PROGRESS
IN TERMS OF LINKING OUR FUNDING
TO THESE THEMES TO ADDRESS THESE
IMPORTANT ISSUES.
FIVE YEARS HAVE GONE BY QUICKLY
AND WE'RE NOW IN THE PROCESS OF
WORKING ON OUR NEXT STRATEGIC
PLAN WHICH WILL BE FROM 2025 TO
2030.
WE PRESENTED IN PART SOME OF OUR
PROGRESS IN TERMS OF THE
RESEARCH AREAS, STEWARDSHIP,
MANAGEMENT AND ACCOUNTABILITY.
OUR STAFF HAS BEEN TRACKING AND
DOCUMENTING ACTIVITIES AND
ACHIEVEMENTS TOWARDS THE CURRENT
OBJECTIVES.
AND WE'RE IN THE PROCESS OF
REFRESHING THE STRATEGIC PLAN.
WE DON'T ANTICIPATE MAJOR
CHANGES IN THE THEMES.
WE DO ANTICIPATE TWEAKS AND
UPDATING BECAUSE SCIENCE
PROGRESSES VERY QUICKLY AND
REMEMBER WHEN WE DID THE LAST
STRATEGIC PLAN IT WAS BEFORE THE
PANDEMIC AND BEFORE A LOT OF
ISSUES RELATED TO RACISM AND THE
GEORGE EMPLOYED EVENTS.
SO WE ARE GOING TO ASK FOR ALL
YOUR INPUT AND THERE WILL BE A
REQUEST FOR INFORMATION
ANTICIPATED IN THE SUMMER OF
THIS YEAR AND THEN WE WILL WORK
ON TWEAKING THE THEMES AND
RELEASING THE STRATEGIC PLAN
PROBABLY NEXT SPRING.
WE'LL START WITH THE FIRST TOPIC
WHICH I'VE BEEN INCREASINGLY
CALLING WOMEN'S HEALTH BELOW THE
BELT BECAUSE THERE'S A LOT OF
DISCUSSION ABOUT WHAT IS WOMEN'S
HEALTH AND WHERE IS NICHD'S
FOCUS IN TERMS OF THE OVER ALL
WOMEN'S HEALTH RESEARCH
INITIATIVE.
NOW, AGAIN SOME WHO ARE
RELATIVELY NEW TO COUNCIL MAY
NOT APPRECIATE THE FACT WE HAVE
12 EXTRAMURAL BRANCHES, THE
BRANCH CHIEFS ARE MOSTLY HERE.
YOU WILL SEE SOME OF THEM IN
PERSON AND SOME OF THEM ON VIDEO
AS THEY PRESENT SOME OF THEIR
CONCEPTS.
THESE ARE BRANCHS THAT HAVE
RELATIONSHIP TO WOMEN'S HEALTH
AND YOU CAN SEE A LOT OF THEM
ARE GYNECOLOGIC HEALTH AND
DISEASE.
THERE'S CONTRACEPTION RESEARCH.
THERE'S FERTILITY AND
INFERTILITY, THERE'S PREGNANCY
AND PERINATOLOGY AND OBSTETRIC
AND PHARMACOLOGY THERAPEUTICS
AND POPULATION DYNAMICS.
WHILE THIS FITS IN WITH THE
PRESIDENT'S WHITE HOUSE WOMEN'S
INITIATIVE CHAMPIONED BY THE
FIRST LADY, WE WERE FORTUNATE TO
GO TO THE SIGNING OF THE
EXECUTIVE ORDER ON MARCH 18 AND
THE PRESIDENT WAS INTERESTED IN
MEETING PEOPLE.
WE WERE NOT AT THE FRONT DESK
WHEN THE ORDER WAS SIGNED BUT HE
BASICALLY WORKED THE ROPES AND
ASKED WHAT WE WERE DOING.
WE WERE WORKING ON THIS.
THE EXECUTIVE ORDER IS MEANT TO
BE A CROSS-GOVERNMENT INITIATIVE
TO PROMOTE COLLABORATIVE
INTERDISCIPLINARY RESEARCH TO
ASSESS UNMET NEEDS IN WOMEN'S
HEALTH RESEARCH AND THERE'S A
SPECIFIC CALL OUT AS I SAID
ABOUT MENOPAUSE BUT ALSO THERE'S
A NEED FOR RESEARCH AGENDA AS
WELL AS COMMON DATA ELEMENTS.
WHAT NIH IS DOING WE HAVE PUT
OUT A NOTICE OF SPECIAL
INTEREST.
WE ARE COLLECTING OPPORTUNITIES
THAT WILL BE A SO-CALLED FRONT
DOOR COLLECTION OF NIH GRANT
OPPORTUNITIES RELATED TO WOMEN'S
HEALTH RESEARCH.
IF YOU HAVE LISTENED TO THE TALK
AROUND THE INITIATIVE AND YOU
MIGHT HAVE HEARD THAT THE
PRESIDENT IS PROPOSING $12
BILLION FOR THIS, AGAIN, THE
PRESIDENT CAN PROPOSE BUT
CONGRESS WILL NEED TO
APPROPRIATE AND THIS WILL NOT
HAPPEN ANYWAY UNTIL 2025 OR EVEN
2026 WHICH WE DON'T KNOW WHAT
WILL BE HAPPENING THEN.
SO IF YOU WERE EXCITED ABOUT
POTENTIAL $12 BILLION ON WOMEN'S
HEALTH RESEARCH IT'S NOT A REAL
NUMBER.
FURTHERMORE, THERE'S BEEN A
DISCUSSION ABOUT A CENTRAL FUND
OF $200 BILLION AND THERE'S NO
NEW MONEY.
WE DON'T REALLY KNOW IF THE $200
BILLION IS A COMPILATION OF WHAT
WE'RE ALREADY FUNDING OR NOT BUT
WE'RE WORKING ON AN EXECUTIVE
SUMMARY THAT HAS BEEN SENT TO
THE WHITE HOUSE AND THERE'S A
PRESSURE BEFORE NOVEMBER.
WHAT HAS NICHD DONE IN RESPONSE
TO THE EXECUTIVE ORDER AND THE
INITIATIVE?
WE HAD AS ONE OF OUR 10
ASPIRATIONAL GOALS IN THE 2020
STRATEGIC PLAN TO IMPROVE THE
DIAGNOSIS, TREATMENT OF
ENDOMETRIOSIS.
IT'S A VERY COMMON CONDITION
THAT AFFECTS ONE IN 10 CHILDREN
WITHOUT ANY PARTICULAR
PREDILECTION FOR RACE OR ETHNIC
BACKGROUND.
IT'S EXTREMELY DIFFICULT TO
DIAGNOSE BECAUSE THE SYSTEMS
INCLUDE PAIN BUT ALSO CAN
INCLUDE OTHER PROBLEMS AND THE
SYMPTOMS CAN OVERLAP WITH OTHER
CONDITIONS.
THE PROBLEM IS THE DIAGNOSIS ON
AVERAGE TAKES SEVEN TO 10 YEARS
AND THERE'S NO NON-INVASIVE
DIAGNOSTIC TEST SO THAT'S A
MAJOR NEED.
RIGHT NOW THE GOLD STANDARD FOR
DIAGNOSIS INCLUDING LAPAROSCOPIC
VISUALIZATION WHICH IS NOT,
NON-INVASIVE.
SO CLINICIANS RELY ON MEDICAL
EXAM AND HISTORY AND SOME
IMAGING BUT THESE TESTS AREN'T
PERFECT AND DON'T DETECT ALL
LESIONS ASSOCIATED WITH
ENDOMETRIOSIS.
THERE'S A MAJOR INNOVATION GAP.
WE WANT TO DEVELOP EARLY AND
ACCURATE ENDOMETRIOSIS TREATMENT
AND AFFECTED PEOPLE WILL NOT BE
WAITING AROUND SEVEN TO 10
YEARS.
IT DOESN'T DO ANYTHING AND THEN
IT JUMPS.
SO WHAT WE'RE PROPOSING IS A
CHALLENGE.
AND IT'S CALLED ACT-ENDO ACRONYM
FOR ADVANCING CURES IN THERAPIES
AND ENDING ENDOMETRIOSIS
DIAGNOSTIC DELAYS.
SO THE PROBLEM IS WE WANT TO
REDUCE THE TIME TO DIAGNOSIS AND
OUR SOLUTION, OUR POST-SOLUTION
WILL BE TO PARTNER WITH NIBIB TO
LEVERAGE THE RAPID ACCELERATION
OF DIAGNOSTIC TECHNOLOGY.
THIS IS THE RAD X TECH APPROACH
USED SUCCESSFULLY TO DEVELOPED
HOME-BASED TESTS FOR COVID.
IT'S AN INNOVATION FUNNEL WHICH
YOU'LL SEE IN THE NEXT SLIDE.
AND THIS WILL HOPEFULLY
ACCELERATE THE TIME TO
DIAGNOSIS, ELIMINATE THE
INVASIVENESS OF CURRENT
TECHNIQUES AND IMPROVE
ACCESSIBILITY, SAFETY,
CONVENIENCE AND REDUCE THE COST
OF DIAGNOSIS.
SO THE INDIVIDUALS OR THE
COMPANIES OR THE INSTITUTIONS
WILL USE FLUIDS AND DISTINGUISH
BETWEEN BENIGN AND MALIGNANT
ENDOMETRIOSIS.
PEOPLE WITH THIS HAVE AN
INCREASED INCIDENTS OF CANCER
AND UTILIZE EPI GENGENOMIC DATA
DIAGNOSE EARLY DISEASE STATES.
IT'S PHASED AND MEANT TO BE LIKE
SHARK TANK IF YOU'RE OBSERVING
AND YOU MAY SEE THE SHARK IN THE
SLIDE, IT'S LIKE SHARK TANK AND
EVENTUALLY THERE WILL BE A PHASE
3 WITH INTERIM MILESTONES AND AT
EACH PHASE THE GROUPS GET A
FINANCIAL PRIZE.
WE'RE GOING TO BE TALKING MORE
ABOUT THE IMPROVE INITIATIVE IN
SEPTEMBER ONCE THE ONGOING
CHALLENGES ARE COMPLETED.
BUT THOSE WHO HAVE BEEN ON
COUNCIL BEFORE YOU'VE SEEN THIS
GRAPHIC WITH THE SIX PARTS AND
SET UP THE 10 CENTERS OF
EXCELLENCE WITH THE DATA HUB AND
IMPLEMENTATION SCIENCE HUB.
THERE ARE TWO WHICH CHALLENGES.
ONE IS RAD X FOR MATERNAL HEALTH
AIMED AT IDENTIFYING POSTPARTUM
WOMEN IN MATERNAL CARE DESERT
AREAS WHO HAVE A PROBLEM.
FOR EXAMPLE, POSTPARTUM
HEMORRHAGE AND IDENTIFYING THOSE
AT RISK FOR POSTPARTUM
HEMORRHAGE AND GET THEM TO A
PLACE TO BE TREATED?
THAT CHALLENGE WILL BE COMPLETED
IN OCTOBER AND THEN WE HAVE
ANOTHER CHALLENGE THAT IS AIMED
AT LOOKING AT COMMUNITY-BASED
SOLUTIONS.
SO, FOR EXAMPLE, HOW CAN THE USE
OF DOULAS I AM -- IMPROVE
MATERNAL HEALTH AND TEACHING
COMMUNITY GROUPS HOW TO BE
COMPETITIVE WITH OTHER GRANT
OPPORTUNITIES AND THAT CHALLENGE
WILL END IN SEPTEMBER.
SO IN THE FALL WE WILL UPDATE
YOU ON THE WINNERS AT LEAST IN
THE COMMUNITY THAT'S PUBLICALLY
ANNOUNCED.
WE HAVE OTHER COMMUNITY
IMPLEMENTATION PROGRAMS AS WELL
AS THE CONNECTATHON DEVELOPING
THE RECORD STANDARDS FOR
PREGNANCY TO ALLOW REAL WORLD
RESEARCH.
SO LET'S GET TO PEDIATRICS NOW.
THERE'S OVERLAP WITH THE
BRANCHES.
PEDIATRIC RESEARCH ENCOMPASSES
THE DEVELOPMENTAL BIOLOGY AND
ANOMALIES BRANCH.
CHILD DEVELOPMENT AND BEHAVIOR,
INTELLECTUAL AND DEVELOPMENTAL
DISABILITIES, PEDIATRIC AND
NUTRITION AND PEDIATRIC TRAUMA
AND CLINICAL ILLNESS, MATERNAL
AND PEDIATRIC INFECTIOUS
DISEASES AND PHARMACOLOGY AND
THERAPEUTICS AND POPULATION
DYNAMICS.
SO I MENTIONED THAT WE SUCCESS
ANY HELD A WORKSHOP WITH THE
PARTNERSHIP OF THE NATIONAL
INSTITUTE OF MENTAL HEALTH ON
THE IMPACT OF TECHNOLOGY AND
DIGITAL MEDIA ON CHILD AND
ADOLESCENT DEVELOPMENT AND
MENTAL HEALTH.
THIS IS A MAJOR ISSUE OF OUR
TIME THAT WAS ONLY ACCELERATED
BY THE PANDEMIC AND ONLINE
LEARNING.
IT WAS EXTREMELY WELL ATTENDED
BOTH IN PERSON AND VIRTUALLY.
THE WORKSHOP PARTICIPANTS
DISCUSSED CURRENT STATE AND
FUTURE DIRECTION OF RESEARCH THE
POSITIVE AND NEGATIVE EFFECTS OF
TECHNOLOGY AND DIGITAL MEDIA.
THERE IS A RECORDING AVAILABLE
AND WE ANTICIPATE THERE WILL BE
A WHITE PAPER TYPE OF SUMMARY OF
THE WORKSHOP AS WELL AND CLEARLY
LEAD TO NEW RESEARCH
OPPORTUNITIES.
I DID WANT TO MENTION ALL OF US.
ALL OF US WE'VE BEEN WAITING NOW
FOR SIX YEARS TO HEAR WHEN ALL
OF US WILL BE ENROLLING
CHILDREN.
THEY SAID LAST YEAR THAT THEIR
NUMBER ONE GOAL WAS TO ENABLE
PEDIATRIC PARTICIPATION.
THEY HIRED DR. VANDREES FROM
VANDERBILT WHO IS A PEDIATRICIAN
TO TAKE THE LEAD IN ROLLING OUT
OPPORTUNITIES FOR PEDIATRICS AND
THEY ACCOMPLISHED QUITE A LOT IN
2023 AND THEY RECRUITED A
PEDIATRIC TEAM.
THEY WROTE AND AMENDED A
PEDIATRIC PROTOCOL.
THEY GOT IRB APPROVAL FOR THE
YOUNGEST OF THE CHILDREN WHO ARE
LINKED TO THEIR MOTHERS SO
THERE'S QUITE A NUMBER OF
PREGNANT PEOPLE ENROLLED.
THEY ADAPTED ALL THEIR
TECHNOLOGY TO SUPPORT PEDIATRIC
PARTICIPATION.
THEY'RE WORKING ON SURVEYS THAT
CAN BE GIVEN TO FAMILIES WHO ARE
ALREADY PARTICIPATING IN ALL OF
US.
THEY'VE IDENTIFIED FIVE INITIAL
SITES FOR RECRUITMENT.
THEY TRAINED STAFF AND
SUCCESSFULLY TESTED ALL THE
SYSTEMS.
THAT'S THE GOOD NEWS.
THE BAD NEWS IS IN FISCAL YEAR
'24 THEY TOOK AN ENORMOUS, $184
MILLION CUT IN THEIR BUDGET.
WHAT WILL BE THE RESULT OF THE
BUDGET CUT.
WE'RE WORKING WITH THEM WAYS TO
IDENTIFY A SMALLER SCALE START
TO PEDIATRIC ENROLLMENT.
IT'S REALLY CRUCIAL.
FULL DISCLOSURE ON THEIR
EXECUTIVE COMMITTEE AND WE HEAR
ABOUT THEIR ACCOMPLISHMENTS.
THIS IS A PROGRAM THAT'S
ACCOMPLISHED A HUGE AMOUNT.
NOW THEY'RE IN A HOLDING PATTERN
BECAUSE OF THE MAJOR BUDGET CUT.
BUT I KNOW PEOPLE ASK ME ALL THE
TIME WHEN IS ALL OF US GOING TO
ENROLL CHILDREN AND THEY ARE
READY TO GO.
THEY'RE FINALLY READY TO GO.
SO WE'RE WORKING WITH THEM TO
SEE HOW WE CAN GO FORWARD IN
THIS AREA.
WE ALSO HAVE THE NIH WIDE
PEDIATRIC CONSORTIUM ESTABLISHED
IN 2018 TO INCREASE
COLLABORATION, COORDINATION IN
PEDIATRIC RESEARCH ACROSS NIH.
THERE'S BEEN A NUMBER OF
ACCOMPLISHMENTS THERE INCLUDING
WORKSHOP ON THE TRANSITION FROM
ADOLESCENT TO ADULT HEALTH CARE
WHICH IS EXTREMELY IMPORTANT
PARTICULARLY FOR ADOLESCENTS
WITH CHRONIC DISEASE.
THIS GROUP WAS VERY ACTIVE AT
THE BEGINNING OF THE PANDEMIC TO
IDENTIFY ISSUES UNIQUE TO BOTH
CHILDREN AND PREGNANT PEOPLE BUT
ACTUALLY WERE GOT FUNDING AND
IDENTIFY COMMON DATA ELEMENTS.
THE GROUP COLLABORATED WITH THE
HEAL INITIATIVE TO ADDRESS
PEDIATRIC PAIN.
THEY'RE ALSO WORKING ON A
STANDARDIZED APPROACH TO
PEDIATRIC CLINICAL TRIAL.
THE CRISIS IN THE PEDIATRIC
WORKFORCE WE TALKED A LITTLE BIT
ABOUT AT THE LAST COUNCIL
MEETING WAS ALSO A TOPIC OF
DISCUSSION FOR THE GROUP.
AND ALSO PEDIATRIC MEDICAL
DEVICES WHICH IS A
PUBLIC-PRIVATE PARTNERSHIP AND
WE HAVE MULTIPLE OTHER NIH
PARTNERS INCLUDING NIBIB AND
OTHER FEDERAL PARTNERS INCLUDING
BARDA AND THE FDA.
THIS IS WHAT WITH THE SUPPORT OF
THE FOUNDATION FOR NIH THE
AMERICAN ACADEMY OF PEDIATRICS
AND VARIOUS ACADEMIC
INSTITUTIONS, CHILDREN'S
HOSPITALS, PHARMACEUTICAL
COMPANIES AND LOOK AT DEVICES
EVALUATED AND APPROVED FOR
PEDIATRIC POPULATIONS.
IT'S ALSO AIMED TO DERISK AND
STREAMLINE PROCESSES ENABLING
TRANSLATION OF MEDICAL ADVANCES
FROM THE BENCH TO BEDSIDE AND
FOR MEDICAL DEVICES FOR CHILDREN
WHICH IS REALLY AN UNMET NEED SO
I WOULD LIKE TO ACKNOWLEDGE THE
OBSTETRIC AND PEDIATRIC
THERAPEUTICS BRANCH THAT HAS
TAKEN A LEADERSHIP APPROACH TO
MOVING THIS FORWARD.
SO YOU'LL HEAR MORE ABOUT THIS
IN THE FUTURE.
AND THEN I DID WANT TO MENTION
WE HAVE A NEW DIRECTOR OF NIH,
DR. BERTAGNOLLI.
AND I CAN PRONOUNCE IN ITALIAN
LAST NAME BECAUSE I HAVE ONE
MYSELF BUT IF YOU WATCHED THE
SENATE HEARING YOU'D KNOW MANY
SENATORS HAVE DIFFICULTY WITH
ITALIAN LAST NAMES AND I WON'T
SAY MORE BUT IT CAME UP MANY
TIMES.
ONE OF DR. BERTAGNOLLI'S
PRIORITIES IS TO DEVELOP A
PRIMARY CARE CLINICAL TRIAL
NETW
NETWORK.
SHE'S ORIGINALLY FROM A RURAL
AREA IN WYOMING.
SHE UNDERSTANDS THE NEEDS OF
RURAL POPULATIONS AND IT IS
FOCUS FOR HER TO USE PRIMARY
CARE AS AN OPPORTUNITY TO DO
RESEARCH THAT'S DISEASE
AGNOSTIC.
THIS IS SOMETHING THAT INCLUDES
ALL THE INSTITUTES AND CENTERS
AND USES REAL WORLD SETTINGS.
IT'S CREATING A FOUNDATION FOR
ENGAGEMENT WITH COMMUNITIES THAT
ARE UNDER REPRESENTED IN
CLINICAL RESEARCH.
THIS COULD INCLUDE RURAL AND
URBAN AREAS UNDER SERVED.
HER OFFICE, THE OFFICE OF THE
DIRECTOR WILL GET INITIAL
FUNDING ASPIRATIONAL $25 MILLION
IN FISCAL '25 BUT CONGRESS HAS
TO APPROPRIATE THAT AND THEY'RE
ANTICIPATING A RAMP UP ASSUMING
THEY CAN MOVE FORWARD.
THEY'RE MOVING VERY QUICKLY
BECAUSE HER POSITION IS A
POLITICAL APPOINTMENT.
SO IF THERE ARE CHANGES THEN
IT'S UNCLEAR WHAT WOULD HAPPEN
TO THIS PROGRAM.
SO THEY ARE ALREADY HAVING
LISTENING SESSIONS AND GATHERING
FEEDBACK AND WANT TO LAUNCH THIS
BEFORE THE END OF THIS FISCAL
AND ALREADY HAVE INTERIM TEAMS
IN PLACE.
TWO MORE THINGS IN THE AREA.
YOU'RE AWARE OF THE FACT THAT ON
YOUR GRANTS THE STIPENDS ARE
GOING TO BE RAISED BY AROUND 4%
FOR PREDOCTORAL TRAINEES AND
AROUND 8% FOR POST-DOCTORAL
SCHOLARS IN THIS FISCAL YEAR.
THIS IS VERY SUBSTANTIAL.
IT'S IN RESPONSE TO A NUMBER OF
DIFFERENT EFFORTS REALLY
ATTEMPTING TO GIVE TRAINEES A
LIVING WAGE.
THE DIRECTORS WEIGHED IN ON
THREE DIFFERENT PLANS AND
SELECTED THIS CURRENT PLAN THAT
WOULD ALLOW FOR IMMEDIATE PAY
INCREASE WITHOUT DRASTIC CUTS IN
THE NUMBER OF NRSA AWARDS THOUGH
TO GIVE -- THE PIE'S NOT GETTING
BIGGER SO TO GIVE INDIVIDUAL
TRAINEES A HIGHER SALARY WE
ANTICIPATE HAVING TO REDUCE
SLIGHTLY THE NUMBER OF
POSITIONS.
OUR GOAL IS TO REACH THE
ADVISORY TO THE DIRECTORS
RECOMMENDED STIPEND LEVEL AROUND
$70,000 IT'S FOR POST DOCTORAL
FELLOWS IN THE COMING YEARS AND
THE CHILDCARE SUBSIDY INCREASED
TO $3,000 THIS FISCAL YEAR PER
TRAINEE SO IF YOU DO HAVE A
COUPLE, EACH ONE OF THEM WOULD
HAVE THE $3,000.
THE OTHER CHANGE THAT IS
OCCURRING -- I JUST PICKED THREE
OVER ALL HIGHLIGHTS TO BRING TO
YOUR ATTENTION EXISTING REVIEW
CRITERIA ARE GOING TO BE
RE-ORGANIZED INTO THREE FACTORS.
THESE CHANGES ARE GOING TO TAKE
PLACE FOR APPLICATIONS SUBMITTED
IN JANUARY OF '25.
THE INVESTIGATOR AND ENVIRONMENT
ARE GOING TO BE EVALUATED AS
SUFFICIENT FOR GAPS IDENTIFIED.
THEY WILL NOT BE INDIVIDUAL
SCORES ANYMORE IN THAT CATEGORY.
IT WILL BE CONSIDERED THE OVER
ALL SCORE AND THERE'LL BE HUMAN
TIME LINE, SUBJECTS GOING TO BE
EVALUATED FOR A MORE RIGOROUS
REVIEW AND I'M SORRY TO OUR
NICHD STAFF, MANY OF THESE
CHANGES WILL FALL ON THE
SHOULDERS OF THE NIH STAFF
RATHER THAN THE STUDY SECTION.
THE GOAL IS IT TO IDENTIFY THE
HIGHEST IMPACT RESEARCH.
I WANTED TO ACKNOWLEDGE
DR. STORRS ELECTED AS AN AAAS
FELLOW LEADING THE ENVIRONMENTAL
GENE REGULATION SECTION AND
HONORED FOR THE FIELD OF
MICROBIOLOGY AND NON-CODING RNAs
AND OXIDATIVE RESPONSE IN YEAST.
WE TEND TO DEVOTE OUR COUNCIL
MEETING TO THE INTRAMURAL
PROGRAM AND IT'S A TREMENDOUS
HONOR.
AND THEN WE HAVE TWO NEW
INSTITUTE AND CENTER DIRECTORS.
SO I'VE BEEN AT NIH SEVEN AND A
HALF YEARS AND THERE'S BEEN A
LOT OF CHANGE.
WE HAVE QUITE A NUMBER OF NEW
INSTITUTE CENTER DIRECTORS BUT
THE NEWEST INCLUDE DR. SEAN
MOONEY AT THE CENTER FOR
INFORMATION TECHNOLOGY.
DR. CANNY NEUZIL THE DIRECTOR OF
THE FOGARTY INTERNATIONAL
CENTER.
DR. MOONEY IS FROM THE
UNIVERSITY OF WASHINGTON AS IS
DR. SIMONI AND THE DIRECTOR OF
THE NATIONAL LIBRARY OF MEDICINE
POSITION IS NOW POSTED.
SO PATTI BRENNAN RETIRED AND
THAT SEARCH IS ONGOING.
WE EXPECT THAT SOME TIME IN THE
NEXT FEW MONTHS THAT THE SEARCH
FOR THE NEW DIRECTOR OF THE
NATIONAL INSTITUTE OF MENTAL
HEALTH WILL START UP AS WELL.
SO DR. GORDON SHORTLY IS LEAVING
NIH TO BE CHAIR OF PSYCHIATRY AT
COLUMBIA UNIVERSITY.
WE ARE HIRING AS USUAL.
WE'RE HAPPY AND I KNOW OUR STAFF
ARE ALL HAPPY TO TALK WITH YOU
SHOULD YOU HAVE KNOWLEDGE OF
PEOPLE WHO WANT TO EXPLORE A
STINT IN GOVERNMENT.
THERE'S MANY ADVANTAGES TO IT.
WE ALSO ARE LOOKING FOR GREAT
SCIENTI
SCIENTISTS WHOA CAN WORK IN OUR
PROGRAM AND THAT'S THE END OF MY
FORMAL REMARKS AND WE HAVE A QR
CODE.
THE OFFICE OF COMMUNICATIONS HAS
CREATED SOME FANTASTIC
ONE-PAGERS ON A VARIETY OF
TOPICS RELATED TO WOMEN'S HEALTH
AND THEY'VE BEEN POPULAR IN OUR
CONGRESSIONAL MEETINGS AND GIVE
A SUMMARY OF WHAT WE'RE FUNDING
IN A PARTICULAR AREA SAY
ENDOMETRIOSIS OR POLY CYSTIC
OVARY SYNDROME TALK ABOUT OUR
ACHIEVEMENTS AND WHAT ISSUES
ARE.
>> THANK YOU FOR WHAT YOU DO AND
THE WHOLE PORTFOLIO IS REALLY
EXCITING TO SEE WHEN YOU SEE
WHAT WE CAN DO.
THE ALL OF US I CALL SOME OF US
WAS WE'RE MISSING A PART OF THE
POPULATION IS IMPORTANT FOR NIH
TO GET BEHIND AND WE HAVE
RECOGNIZE THERE'S A FINITE POT
OF MONEY.
I WANTED TO HEAR THOUGHTS AND
HOW WE CAN HELP PRIORITIZE THIS.
SO MUCH HAS BEEN INVESTED IN ALL
OF US AND THERE'S A GREAT
OPPORTUNITY TO REALLY ENSURE A
BENEFIT FROM THAT AS WELL.
>> I AGREE 100%.
I'VE WANTED TO PRESENT THAT
SLIDE.
WE'VE DONE AN ENORMOUS AMOUNT
AND SET UP THE STRUCTURE FOR THE
CHILDREN AND THEY HAVE ALREADY
ACCOMPLISHED A NUMBER OF THINGS
FOR ADULTS AS WELL.
SO I THINK REALLY THE HELP CAN
COME FROM SPEAKING ABOUT US
BECAUSE MOST OF THE BUDGET IS
FLAT THERE'S A SLIGHT INCREASE
IN THE IMPROV INITIATIVE.
THE CUTS CAME AT THE EXPENSE OF
BIG PROGRAMS LIKE THE BRAIN
INITIATIVE AND ALL OF US.
I THINK CONGRESS NEEDS TO BE
MADE AWARE OF WHAT THEY'VE
ALREADY ACCOMPLISHED.
AND WE COULD NEVER MAKE UP $100
MILLION.
THEY'RE TRYING TO GET SMALLISH
CONTRIBUTIONS FROM THE
INSTITUTES AND CENTERS.
NOW, WE DON'T FUND ALL PEDIATRIC
RESEARCH.
WE ONLY FUND 16% PEDIATRIC
RESEARCH.
BUT WE HAVE BEEN VERY COMMITTED
TO ALL OF US FROM THE GET GO AND
UNDERSTAND THE IMPORTANCE OF
CHILDREN AND IF THERE'S ONE
PIECE OF ADVICE, TRY TO
COMMUNICATE WITH YOUR CONGRESS
PEOPLE ABOUT THE IMPORTANCE OF
THE PROGRAM AND HOW IT BENEFITS
CHILDREN AND ADULTS AND IN
PARTICULAR THE FACT THEY HAVE
RECRUITED SUBSTANTIAL PERCENTAGE
OF UNDER REPRESENTED MINORITIES.
THAT WAS A GOAL FROM THE
BEGINNING.
>> IS THIS AN OPPORTUNITY THEN
FOR THE NIH PEDIATRIC CONSORTIUM
TO WORK TOGETHER ON THAT?
>> WE'VE ALWAYS WORKED TOGETHER
AND SARA van DREES IS A MEMBER
AND JUST SPOKE RECENTLY WHAT HAS
BEEN ACCOMPLISHED TO THE WHOLE
GROUP.MARCEL, DID YOU HAVE A
QUESTION?
>> THANK YOU.
THAT WAS VERY HELPFUL AND
INFORMATIVE.
I HAD A QUESTION.
FIRST, IT'S GREAT THE STIPENDS
ARE GOING TO BE INCREASED
BECAUSE THERE'S CLEARLY AN ISSUE
IN THE RESEARCH PIPELINE.
I WANTED TO CLARIFY IF I HEARD
CORRECTLY BECAUSE IT'S OBVIOUSLY
A FIXED BUDGET AND THE BUDGET'S
NOT BETTGETTING BIGGER.
DOES IT MEAN LESS POSITIONS WILL
BE FUNDED?
>> NOT PHYSICIANS, I SAID
POSITIONS.
WE'RE SUBMITTED TO PHYSICIAN
SCIENTISTS.
BUT IT'S SIMPLE MATH.
WE HAVE A FIXED BUDGET.
TRAINING PROGRAM DIRECTORS WILL
HAVE TO MAKE DECISIONS HOW TO
USE THE BUDGETS.
OTHER QUESTIONS?
>> I HAD A QUESTION.
THIS IS DR. CHANCE.
REGARDING THE $12 MILLION
PROPOSED FOR THE WOMEN'S HEALTH
RESEARCH INITIATIVE, MY QUESTION
IS HOW MUCH OF THE BUDGET IS
CURRENTLY USED FOR WOMEN'S
HEALTH AT NIH?
JUST TO UNDERSTAND WHAT THE
BUDGET MEANS.
>> SO I WISH I COULD GIVE YOU A
STRAIGHTFORWARD ANSWER.
THAT'S A MAJOR TOPIC OF
DISCUSSION BECAUSE THERE IS A
PERCEPTION THAT NIH IS NOT
FUNDING WOMEN'S HEALTH RESEARCH.
SO EXCLUSIVELY IT'S SOMEWHERE
BETWEEN $4 BILLION AND $5
BILLION BUT WOMEN ARE BEING
STUDIED IN MANY AREAS ALONG WITH
MEN SO THEY'RE NOT BREAKING OUT
THOSE GRANTS, FOR EXAMPLE.
SO, WE'RE TRYING TO GET A BETTER
HANDLE ON HOW WE'RE SUPPORTING
WOMEN'S HEALTH RESEARCH AND PART
OF THAT WILL COME FROM PROGRAMS
NEW TOPICS IN THE RCDC CATEGORY
TO BETTER MONITOR TRENDS.
NOW, REMEMBER THAT EVEN
SOMETHING AS COMMON AS PREGNANCY
DID NOT HAVE A CATEGORY IN THE
RESEARCH CONDITION AND DISEASE
CATEGORIZATION.
THAT'S RCDC A PUBLIC RESOURCE
YOU CAN LOOK UP AND TRACK THE
AMOUNT OF FUNDING.
THE PREGNANCY WASN'T EVEN A
CATEGORY UNTIL 2017.
SO IT WAS VERY HARD TO KNOW HOW
MUCH NIH WAS SPENDING OVER ALL
ON PREGNANCY.
SO AS ONE ASPECT OF THIS WHOLE
OVER ALL INITIATIVE THEY'RE
LOOKING AT CATEGORIES TO BETTER
DOCUMENT WHAT'S BEING SPENT.
$4 BILLION TO $5 BILLION FOR
CURRENT HEALTH RESEARCH.
AND THERE'S DISCUSSIONS WITH OUR
COLLEAGUES ABOUT WHAT TO INCLUDE
IN THE DEFINITION OF WOMEN'S
HEALTH RESEARCH.
MARIA SHRIVER IS VERY ACTIVE IN
DISCUSSIONS WITH THE WHITE HOUSE
AND SHE HAS A CERTAIN CONCEPT
BASED ON WHAT EUNICE SHRIVER
EXPERIENCED AND HER FATHER HAD
ALZHEIMER'S BUT WOMEN HAVE ARE
MORE COMMONLY AFFECTED BY ZIRMZ
OF ALZHEIMER'S AND HER MOTHER
HAD CONDITIONS AND VARIOUS
THINGS.
WE ARE TAKING THE APPROACH THAT
WOMEN'S HEALTH SHOULD INCLUDE
REPRODUCTIVE HEALTH FOR MANY
REASONS.
INCLUDING PREGNANCY AS A RISK
FACTOR FOR LATER ONSET
COMPLICATIONS, RECENT DATA USING
A SWEDISH DATABASE SUGGESTS THAT
A LIFE SPAN OF PEOPLE DIED
EARLIER THAN THEIR COUNTERPARTS
IF THEY HAD COMPLICATIONS WITH
PREGNANCY SO WE THINK IT'S VERY
IMPORTANT TO INCLUDE THE
PREGNANCY HISTORY AND THE OVER
ALL PICTURE OF WOMEN'S HEALTH
AND HOW IT'S A STRESS TEST WHICH
IS ONE OF OUR STRATEGIC PLAN
THEMES.
HOW IT'S A STRESS TEST FOR LATER
HEALTH.
THE SHORT ANSWER IS THERE'S A
LOT OF DISCUSSION OF WHAT IS
WOMEN'S HEALTH AND WHAT ARE WE
SPENDING ON WOMEN'S HEALTH.
PATRICIA.
>> I'M WONDERING ALONG THOSE
LINES AND MAYBE YOU'VE ALLUDED
TO THAT THE DISCUSSION REGARDING
SPECIFIC TO WOMEN, SPECIFIC TO
WOMEN WHO CAN BECOME PREGNANT
AND REPRODUCTIVE HEALTH AND THE
DISCUSSION ON STUDIES AND
CLINICAL AND PRE-CLINICAL THAT
INCLUDE FEMALE, NOT JUST MALES
IN THE POPULATION IF IT'S A
CONDITION THAT CAN AFFECT BOTH
GENDERS.
HAS THERE BEEN A BIFURCATION OR
DISCUSSION ALONG THOSE TRACKS?
I KNOW IT'S COMPLICATED.
>> AGAIN, WE'RE IN DISCUSSIONS
WHAT THIS ALL MEANS.
THE WHITE HOUSE HAS A CERTAIN
IDEA.
THEY ARE NOT NECESSARY DOING THE
SCIENCE SO IT'S A WORK IN
PROGRESS.
I KNOW ALISON IS INVOLVED IN A
NUMBER OF HEALTH AND HUMAN
SERVICES COMMITTEES THAT ARE
ALSO ADDRESSING THIS ISSUE.
DO YOU WANT TO MAKE A COMMENT?
>> I THINK THE WAY THIS IS
PLAYING OUT IS THAT MATERNAL
HEALTH RESEARCH HAS ITS OWN
STRATEGIC DIRECTION AND
BLUEPRINT FOR MATERNAL HEALTH
RESEARCH AND WHITE HOUSE
TRACKING AND SEPARATE REPORTS TO
CONGRESS AND OTHER FUN POLICY
DOCUMENTS.
THEN WE HAVE REPRODUCTIVE HEALTH
ACCESS WHICH IS ALSO BEING LED
BY THE WHITE HOUSE AND HAS
SEPARATE EXECUTIVE ORDERS AND
THEN WITHIN HHS A SEPARATE
COORDINATING COMMITTEE THAT HAS
LEGISLATIVE POLICY, LEGAL PIECES
AND THEN WOMEN'S HEALTH PIECE.
SO I THINK THERE'S DIFFERENT
WAYS WE ARE APPROACHING
DIFFERENT ISSUES BECAUSE THEY'RE
IN DIFFERENT STAGES OF MATURITY.
THE REPRODUCTIVE ISSUE IS STILL
EVOLVING AND COULD EVEN CHANGE
THIS MONTH.
OUR ABILITY TO APPROACH THAT
FROM A RESEARCH AND FUNDING
PERSPECTIVE KEEPS CHANGING
BECAUSE THE RULES KEEP CHANGING.
TO THE EXTENT WE CAN THINK OF
WOMEN AS WHOLE PEOPLE THAT HAVE
A LIFE SPAN THAT STARTS EVEN
BEFORE BIRTH, DIANA HAS POINTED
OUT GENETICALLY SOME
DISTINCTIONS.
WE HAVE TO THINK ABOUT IT FROM A
RESEARCH PERSPECTIVE
DIFFERENTLY.
>> I WOULD SAY IT'S AN
OPPORTUNITY.
THERE HASN'T PREVIOUSLY BEEN
THIS LEVEL OF CONVERSATION ABOUT
WOMEN AND ABOUT WOMEN'S HEALTH.
WE NEED TO TAKE ADVANTAGE OF THE
OPPORTUNITY AND IT CERTAINLY
WILL INFLUENCE OUR RESEARCH
PORTFOLIO NO MATTER WHAT HAPPENS
POLITICALLY FOR WITH THIS
RESEARCH INITIATIVE.
YES, CYNTHIA I WAS WAITING FOR
YOU TO RAISE YOUR HAND.
>> JUST THE CONVERSATION HAS
BEEN VERY INTERESTING AND I'M
LISTENING AND LEARNING AS A NEW
MEMBER SO THANK YOU FOR YOUR
PRESENTATION.
THE QUESTION I HAD IS YOU SHOWED
THE PROPORTION OF ALLOCATIONS TO
THE PORTFOLIO WITHIN THE
INSTITUTE WITH I THINK 55% WAS
PEDIATRICS AND 30% WOMEN'S
HEALTH AND 15% FOR THE OTHER,
REHAB.
HAS THAT EVOLVED OR HAS IT BEEN
SIMILAR OR IS THERE A TARGET
YOU'RE LOOKING FOR?
>> IT HAS EVOLVED OVER TIME.
I THINK, FOR EXAMPLE,
DR. ALEXANDER WHO WAS THE
DIRECTOR OF NICHD FOR 23 YEARS
HIS FOCUS WAS VERY MUCH ON CHILD
DEVELOPMENT AND THAT'S ONE OF
THE REASONS WHY, WELL, HE ALSO
VOLUNTEERED TO BE IN NICHD
BECAUSE OF THE CONNECTION OF
INTELLECTUAL AND PHYSICAL
DISABILITY.
MY INTERESTS HAVE ALWAYS BEEN
SPLIT BETWEEN PEDIATRICS AND
OBSTETRICS AND TIMES HAVE
CHANGED AND THE RECOGNITION OF
DEVELOPMENTAL ORIGINS OF HEALTH
AND DISEASE, THE CONNECTION
BETWEEN PREGNANCY, THE HEALTH OF
A PLACENTA FOR EXAMPLE AND THE
LONG-TERM EFFECTS ON THE CHILD
WHO THEN BECOMES THE ADULT IT
SEEMS LIKE YOU CAN'T TAKE THOSE
SEPARATELY.
I DON'T KNOW EXACTLY BUT I WOULD
VENTURE TO GUESS THE PERCENTAGE
OF REPRODUCTIVE RELATED RESEARCH
HAS INCREASED.
AND I SAID 16% -- WE ACCOUNT FOR
16% OF NIH'S BUDGET IN CHILD
HEALTH RESEARCH BUT IT'S OVER
50% OF MATERNAL HEALTH RESEARCH
AT NIH IS FUNDED BY NICHD.
SO, WE REALLY OUR NAME IS IN THE
MISNOMER WE'RE THE LEAD
INSTITUTE FOR WOMEN'S HEALTH
RESEARCH AS WELL.
NCI SPENDS MORE MONEY ON FOR
EXAMPLE BREAST CANCER, FEMALE
CANCERS.
IF YOU LOOK AT ABSOLUTE DOLLARS
THEY SPEND A LOT OF MORE BUT
ALSO HAVE A BIGGER DENOMINATOR
THAN WE HAVE.
EMMA.
>> ANNA.
I WAS HOPING YOU COULD ELABORATE
A BIT HOW YOU THINK OF
INCORPORATING THE SOCIAL
DETERMINATES OF HEALTH IN THIS
VERY AMBITIOUS RESEARCH AGENDA
AS IT RELATES TO WOMEN'S AND
CHILDREN.
>> SOCIAL DETERMINATES OF HEALTH
ARE VERY MUCH INCLUDED IN EACH
OF THE THEMES AND ALSO AT LEAST
HEALTH DISPARITIES WAS INCLUDED
AS A CROSS-CUTTING THEME IN THE
PREVIOUS STRATEGIC PLAN AND I'M
SURE WE WILL BE CONTINUING A
FOCUS ON BOTH HEALTH
DISPARITIES, SOCIAL AND
ENVIRONMENTAL ASPECTS OF HEALTH
AS WELL.
WHEN WE START TO PRESENT YOU'LL
SEE IT IN THE SUBTOPIC AREAS.
>> ONE QUICK FOLLOW-UP.
DOES ANY OF THAT CONSIDER THE
POSSIBILITY OF THINKING OF
SOCIAL OUTCOMES THAT ARE
AFFECTED BY HEALTH AND HEALTH
INTERVENTIONS?
>> IN WAY WAY THIS IS A GREAT
SEGUE TO ONE OF OUR GUEST
SPEAKERS THE DIRECTOR OF THE
OFFICE OF BEHAVIORAL AND SOCIAL
HEALTH.
SO I WILL WAIT FOR DR. SIMONI'S
TALK.
>> DR. BIANCHI, DR. PERRY HAS A
QUESTION ONLINE.
>> GOOD MORNING.
GREAT PRESENTATION.
IT WAS SUPER HELPFUL.
ONE OF MY QUESTIONS WAS AROUND
MENOPAUSE.
YOU MENTIONED PREMATURE
MENOPAUSE AND MOST MENOPAUSE IS
NOT PREMATURE.
IT HAPPENS NATURALLY AND THERE'S
AN AGE GROUP NIH DOESN'T
CONSIDER TO BE CHANGES OR FIT
WITHIN THEIR PORTFOLIO SO IS
NICHD ANTICIPATING EXPANDING ON
MENOPAUSE AND PERIMENOPAUSE.
>> THANK YOU GENEVIEVE FOR THE
QUESTION.
AS THE TREMENDOUS CONGRESSIONAL
INTEREST IN MENOPAUSE.
WE HAVE ALREADY HAD PRELIMINARY
DISCUSSIONS WITH THE NATIONAL
INSTITUTE ON AGING WHICH IS THE
INSTITUTE THAT CURRENTLY FUNDS
MOST THE RESEARCH ON MENOPAUSE.
SO THERE ARE DEFINITELY AREAS
FOR US TO WORK TOGETHER AND LOOK
AT A CONTINUUM.
WHEN I MENTIONED EARLY MENOPAUSE
IS WHAT WE'RE CURRENTLY FUNDING
BUT WITH THE INCREASED INTERESTS
HOPING IT TRANSLATES TO DOLLARS
AND OPPORTUNITIES.
WE KNOW -- WHEN DR. BERTAGNOLLI
WAS TALKING ABOUT HER MEETINGS
AND SHE HAS BEEN INCREDIBLE IN
TERMS OF MEETING MANY CENTER
SENATORS, GOING ON THE ROAD TO
MEETING OTHER SENATORS AND
CONGRESSIONAL REPRESENTATIVES,
SHE SAID MORE THAN ONE
U.S. MEMBER ASKED HER TO FIX
MENOPAUSE.
SO, I ANTICIPATE OPPORTUNITIES
AND WE HAVE AN EXCELLENT
RELATIONSHIP AND ARE
ANTICIPATING DOING MORE.
>> OFTEN IT'S FELT LIKE WHERE
IT'S NOT MATERNAL AND NOT IN THE
AGE RANGE THAT OFTEN IS
CONSIDERED OF INTEREST OF NIA.
IT'S GREAT TO HEAR.
THANK YOU.
>> MARCEL.
>> THANK YOU.
ALONG THAT LINE I HAD A
QUESTION.
YOU MENTIONED MATERNAL HEALTH IS
LARGELY FUNDED AND 30% GOES TO
REPRODUCTIVE HEALTH I SUSPECT A
LOT GOES TO MATERNAL HEALTH AND
SINCE NICHD IS THE LARGEST
FUNDER OF WOMEN'S HEALTH
NON-PREGNANCY RELATED DO YOU
HAVE AN ESTIMATE HOW MUCH GOES
TO NON-PREGNANCY RELATED --
>> ACTUALLY A CONSIDERABLE
AMOUNT WHEN I WENT TO THE SLIDE
ON MATERNAL HEALTH, THE
GYNECOLOGIC HEALTH AND DISEASE
BRANCH WHICH IS A RELATIVELY NEW
BRANCH HAS BEEN AN AREA THAT'S
BEEN GROWING.
WE HAVE A NEW CHIEF OF THAT
BRANCH AND BECAUSE OF THE ACT
AND WE HAVE MADE IT CLEAR WE OWN
ENDOMETRIOSIS AND WE'RE THE
LEADER IN THAT RESEARCH AND WHY
IT'S IMPORTANT AND WHY IT'S AN
AREA FOR FURTHER
MULTI-DISCIPLINELY RESEARCH AND
WE HAVE GYNECOLOGIC HEALTH AND
DISEASE INCLUDING PELVIC FLOOR
DISORDERS AND PCOS AND ENDO.
WE HAVE FERTILITY AND
INFERTILITY.
SO WE HAVE CONTRACEPTION AND
THEN WE HAVE PEDIATRIC AND
OBSTETRIC PHARMACOLOGY AND THEN
POPULATION DYNAMICS WHICH IS NOT
AS SPECIFIC BUT MORE FAMILY
RELATED.
I THINK IT'S NOT TRUE OUR
WOMEN'S HEALTH AREA IS
EXCLUSIVELY OR THE MAJORITY IS
IN MATERNAL HEALTH.
YES, WE HAVE LOTS OF OB-GYN
INTEREST HERE.
>> YEAH, I'M VERY INTERESTED IN
THIS CONVERSATION BECAUSE IT'S
JUST SO FASCINATING PARTICULARLY
AS YOU MENTION ED KNOW RECENT
PAPER DEFINING THE OBSTETRIC
OUTCOMES WITH LONG-TERM
CONSEQUENCES AND PREECLAMPSIA
AND ALL THOSE AND YOU HAVE TO
HAVE A WELL PHENOTYPED OBSTETRIC
CIRCUMSTANCE TO UNDERSTAND WHAT
HAPPENS DOWN THE LINE.
IT'S CHALLENGING TO STUDY THAT
WITHIN THE CONFINES OF THE WAY
OF THE FUNDING.
YOU HAVE THIS WELL DESCRIBED
OBSTETRIC PHENOTYPE BUT DON'T
HAVE TIME TO LOOK FIVE, SEVEN
YEARS DOWN THE LINE OR PARTNER
WITH ANOTHER INSTITUTE THAT
DOESN'T HAVE THE OBSTETRIC
PHENOTYPE.
I'M WONDERING HOW TO RESOLVE
SOME OF THOSE ISSUES.
>> IT'S GOING TO TAKE A BIG DATA
APPROACH AND COMMON DATA
ELEMENTS AS YOU SAID.
REFINED PHENOTYPING AND IN
SWEDEN YOU GET A HEALTH I.D. FOR
YOUR LIFE.
YOU CAN TAKE THE CURRENT
POPULATION OF WOMEN IN THEIR 50s
AND 60s AND LOOK BACK AT THEIR
PREGNANCY HISTORIES.
IT WILL BE HARD FOR US TO DO
THAT BECAUSE PEOPLE MY AGE WE
HAD PAPER RECORDS YOU COULDN'T
READ THE DOCTOR'S HANDWRITING.
I THINK IT WILL TAKE PARTNERSHIP
WITH COUNTRIES WHO DO A BETTER
JOB OF TRACKING PEOPLE THROUGH
THEIR LIFE SPAN BUT THE PROBLEM
WITH A PLACE LIKE SWEDEN IS IT'S
NOT VERY DIVERSE AND MAY NOT
REFLECT THE DIVERSITY OF THE
UNITED STATES.
FINALLY A PEDIATRICIAN.
>> HAVING A WELL PHENOTYPED
LONGITUDINAL COHORT FROM
PREGNANCY OR POSSIBLY AS YOU
SUGGEST THE ANSWER IS TO WORK
WITH COUNTRIES THAT HAVE
NATIONAL HEALTH RECORDS AND
OTHER TERRIBLY IMPORTANT OUTCOME
THAT'S HARD TO TRACK TONE
VALIDATED AND HOPING THERE'LL BE
OPENNESS TO DEVELOPING SMART
COHORTS I THINK BIG DATA
ANALYSIS CAN HELP GAIN NEW
INSIGHTS.
>> AGAIN, SOMEBODY ASKED HOW CAN
YOU HELP US, YOU CAN HELP US BY
PROMOTING THE CONCEPT THAT
PREGNANCY IS NOT A DISCREET LIFE
EXPERIENCE.
IT'S A CONTINUUM.
ONE OF THE THINGS THAT STRUCK US
THAT WE'RE PROBABLY 200 PEOPLE
AT THE SIGNING OF THE EXECUTIVE
ORDER AND I KNOW A LOT OF OBs.
I DON'T KNOW EVERYBODY BUT I WAS
LOOKING AROUND THE ROOM AND
DIDN'T SEE A WHOLE LOT OF
OB-GYN'S EFFORT AND PART OF THE
ISSUE ALISON MENTIONED THAT
PREGNANCY AND MATERNAL HEALTH IS
AN A DIFFERENT AREA AND THAT'S
THE VICE PRESIDENT'S AREA OF
FOCUS.
SO WARE TRYING TO PROMOTE THE
CONCEPT THAT PREGNANCY IS
CONNECTED TO LATER WOMEN'S
HEALTH.
SO IF YOU CAN HELP US TO
COMMUNICATE THAT ISSUE WE WOULD
APPRECIATE IT.
AM I AT TIME?
>> DR. NEIL PERRY HAS A
QUESTION.
>> I AGREE SOME PRAISES LIKE
SWEDEN DATA IS GREAT BUT IT'S
SUCH A HOMOGENOUS POPULATION AND
YOU SAID THAT AND I WANT TO
ELEVATE THAT BECAUSE IF WE MAKE
ASSUMPTIONS WITH A HUGE PORTION
OF THIS COUNTRY ARE EXCLUDED I
WOULD HAVE GREAT CONCERNS.
I'D BE VERY THOUGHTFUL AND
CAREFUL IN DOING THINGS LIKE
THAT.
>> THANK YOU FOR THAT COMMENT.
>> I JUST WANTED TO COME BACK TO
THIS RELATED TO ALL OF US, THE
REPRODUCTIVE HEALTH PHENOTYPING
AND PHENOTYPE RELATED
INFORMATION TO WOMEN'S HEALTH,
HAS NICHD PROVIDED INPUT ON THAT
ASPECT OF ALL OF US?
>> YOU'RE SHAKING YOUR HEAD.
SO THEY HAVE SEVERAL TENS OF
THOUSANDS OF WOMEN WHO WERE
PREGNANT AT THE TIME OF
ENROLLMENT SO THAT'S GOOD NEWS.
THEY ALSO HAVE PREGNANCY
HISTORIES FROM THE MEDICAL
RECORD BUT IF NAHETA DOESN'T
KNOW -- I WILL SAY THAT I TRIED
PLAYING AROUND WITH IT ONE TIME.
I WAS LOOKING FOR A PARTICULAR
VARIANT IN A GENE AND I WAS
TRYING TO SEE WHETHER IT WAS
ASSOCIATED WITH POSTPARTUM
MYOPATHY AND IT WAS POSSIBLE TO
DO THAT AND ASK THE SECOND
QUESTION IS IT RELEVANT FOR
BLACK WOMEN AND YOU COULD DO
THAT BUT I DON'T KNOW WHO
PROVIDED THE INPUT FOR THE
CATEGORIES BUT THERE WAS
CARDIOPATHY AND RECENTLY LEARNED
THEY HAVE AN OPPORTUNITY FOR
RESEARCH.
YOU'LL HEAR MORE TODAY.
>> IT'S NOT EASY TO GET DATA ON
INFERTILITY AND THOSE ISSUES
THROUGH ALL OF US.
WE TRIED.
>> OKAY.
I WILL CONVEY THAT TO JOSH
DENNY.
>> THEY HAVE ACCESS TO
ELECTRONIC HEALTH RECORDS SO
ANYTHING POTENTIALLY IS
SEARCHABLE.
SO THERE MAY NOT COLLECT IT AS A
GENERAL CATEGORY BUT HAVE ACCESS
TO IT THAT COULD BE
INTERROGATED.
YOU MAY NOT SEE ALL OF IT.
IT WILL BE IN THE LARGER DATA
SET.
>> THAT WAS NAHITA NAKU TRA THE
CHIEF OF OUR TECHNOLOGY BRANCH.
REBEKAH YOU'RE KEEPING TIME.
>> I THINK WE'RE READY TO MOVE
ON.
>> OKAY.
ONE MORE QUESTION?
>> YES, GO.
>> JOSÉ.
GOING BACK TO THE FUNDED
CHALLENGES FOR ALL OF US.
I WONDER IF THIS IS AN
OPPORTUNITY FOR INDUSTRY AS WELL
AND FOUNDATIONS AND EVEN THE
PUBLIC.
I DON'T SEE -- I WOULD LIKE TO
HELP WITH THIS AND --
>> SO THANK YOU FOR THAT
COMMENT.
I KNOW THAT IN PRIOR YEARS NICHD
HAD NOT INTERACTED WITH INDUSTRY
BUT THAT HAS CHANGED.
WE HAVE INDUSTRY AS PARTNERS FOR
EXAMPLE IN THE PUBLIC-PRIVATE
PARTNERSHIP TO DEVELOP PEDIATRIC
DEVICES.
WE WORK WITH THE FOUNDATION FOR
NIH COMMITTED TO GETTING
INDUSTRY PARTNERS TO FUND COMMON
SHARED RESEARCH PROJECTS.
SO, I DIDN'T CALL IT OUT
SPECIFICALLY BUT WE ARE WORKING
WITH INDUSTRY AND PARTICULARLY
IN AREAS OF CONTRACEPTION AND
WOMEN'S HEALTH, THERE'S
TREMENDOUS INTEREST IN FEMME
TECH FOR EXAMPLE.
>> YOU SAW THE FNIH THERE.
THAT'S ONE WAY TO PARTNER AND
GET MATCHING DOLLARS FOR EXAMPLE
THE FETAL MONITORING ARE IS IN
COLLABORATION WITH THE GATES
FOUNDATION AND IN CASE YOU HAVE
INCREDIBLY WEALTHY PEOPLE IN
YOUR LIFE, WE HAVE A GIFT FUND.
WE DO RECEIVE GIFTS THERE.
THERE ARE PEOPLE WHO SEND US $20
CHECKS FOR GENERAL RESEARCH
SUPPORT.
AND CMR HAS A GIFT FUND.
THAT'S ONE OF THE THINGS WE DID
ONE OF THE FIRST THINGS WE DID
IN MCRR IF YOU KNOW SOMEONE WITH
A COUPLE BILLION LAYING AROUND
WE'RE HAPPY TO TALK TO THEM.
WE CAN'T SOLICIT THE GIFT BUT WE
HAVE A GIFT FUND TO WHICH THEY
CAN CONTRIBUTE.
THERE'S WAYS FOR THE PUBLIC TO
INTERACT WITH US AS WELL.
>> OKAY.
WELL, THANK YOU FOR YOUR GREAT
QUESTIONS AND WE'LL MOVE ON.
>> ALL RIGHT.
SO WE'RE NOW GOING TO HEAR MORE
ABOUT NICHD'S SUPPORT OF
TRAINING IN OUR EXTRAMURAL
PROGRAM.
YOU PROBABLY REMEMBER AT THE
JANUARY COUNCIL MEETING AN
EXTRAMURAL TRAINING WORK GROUP
IS SUPPORTING TO CHANGE THE
WORKFORCE OF THE FUTURE.
WE HAD A LONG DISCUSSION WITH
YOU ABOUT THIS TOPIC IN JANUARY.
NOW WE'LL HEAR FOLLOW-UP FROM
THE WORK GROUP AND SPEAKERS
INCLUDE DR. GINDHART OF THE
DIRECTOR OF THE EXTRAMURAL
ACTIVITIES AND CO-CHAIR OF THE
EXTRAMURAL TRAINING WORK GROUP
AND DR. LESLY SAMEDY BATES A
MEMBER OF THE WORK GROUP.
>> THANK YOU, REBEKAH AND
DR. BIANCHI TO GIVE US AN
OPPORTUNITY TO TALK ABOUT OUR
PROGRESS IN OUR TRAINING AND
CAREER DEVELOPMENT GOALS.
THANK YOU ALL FOR YOUR ATTENTION
AS WELL.
WHAT I'M GOING TO DO IS TALK
ABOUT OUR PROGRESS SINCE THE
COUNCIL PRESENTATION IN JANUARY
AND LESLY WILL TALK ABOUT HER
WORK WITH THE TRAINEES OF THE
CLINICAL PHARMACOLOGY TRAINING
NETWORK AND THEN WE'LL HAVE TIME
FOR QUESTIONS.
AND WE'LL HAVE TALK ON WHAT WE
INTEND TO DO IN THE FUTURE AND
WE'LL TALK A BIT ABOUT THE
RESULTS OF OUR REQUEST FOR
INFORMATION IN WHICH WE ASK THE
COMMUNITY FOR FEEDBACK ON THE
RECOMMENDATIONS APPROVED BY
COUNCIL IN JANUARY.
JUST TO GIVE BACKGROUND THE LAST
TIME NICHD LOOKED HOLISTICALLY
AT THE TRAINING ACTIVITIES WAS
2016 AND A LOT HAS HAPPENED
SINCE 2016.
I THINK WE WOULD ALL AGREE TO
THAT.
IN RESPONSE TO THAT, THAT TIME
GAP AND TO GUIDANCE IN THE NIH
AND NICHD STRATEGIC PLANS A
WORKING GROUP COMPOSED OF NICHD
STAFF WAS CREATED IN JANUARY
2023 AND THE GOAL OF THAT GROUP
WAS TO HELP NICHD -- IDENTIFY
OPPORTUNITIES FOR EXTRAMURAL
TRAINING AND CAREER DEVELOPMENT
PROGRAMS TO PREPARE THE FUTURE
WORKFORCE TO ADDRESS NICHD'S
MISSION AND ANOTHER WAY OF
PUTTING THIS IS TO NOT JUST
THINK ABOUT WHAT NICHD IS
SUPPORTING BUT WHO ARE THE
SCIENTISTS PARTICIPATING IN
NICHD RESEARCH AND WHERE THEY
ARE WORKING.
SO THE TRAINING AND CAREER
DEVELOPMENT WORK GROUP MET FROM
JANUARY TO DECEMBER 2023 TO
DEVELOP SIX RECOMMENDATIONS AND
32 ACTION ITEMS ACROSS THREE KEY
AREAS.
SO ONE OF THESE AREAS WAS CAREER
DEVELOPMENT.
WE TALKED ABOUT THAT AT THE LAST
COUNCIL.
PRE-AND POST-DOCTORAL TRAINING
PROGRAMS AND ALIGNING OUR
STRATEGIC RESEARCH TO FUND THE
NEXT GENERATION OF RESEARCH.
TO REMIND YOU OF WHAT WE TALKED
ABOUT AT LAST COUNCIL WAS
PRESENTED BY WORKING GROUP
CO-CHAIR TERESA CRUZ, WE HAD SIX
GOALS.
ONE TO RETHINK HOW WE TALK ABOUT
OUTCOME AND SUCCESSFUL OUTCOME
IS NOT JUST GETTING AN R01.
THERE ARE SUCCESSFUL OUTCOMES
BESIDES THAT AND THINK HOW TO DO
TRAINING, K12s AND B32s TO
CREATE A COMMUNITY OF SUPPORTED
RESEARCH.
DIVERSIFY THE RESEARCH AND
REINVIGORATE THE LOAN REPAYMENT
PROGRAMS THAT SUPPORT NIH FUNDED
RESEARCH AT NICHD AND THEN TO
USE THE TRAINING PROGRAMS TO
SUPPORT STRATEGIC --
[NO AUDIO]
TO RECAP IN JANUARY THESE
RECOMMENDATIONS WERE PRESENTED
AND APPROVED BY COUNCIL AND IN
FEBRUARY THE DIVISION OF
EXTRAMURAL RESEARCH, ACTIVITIES
IMPLEMENTATION WORKING GROUP WAS
FORMED TO SUPPORT THAT
RECOMMENDATION TO THE ACTION
ITEMS.
AND WE ALSO RELEASED AN RFI
WE'LL TALK ABOUT AT THE END OF
FEBRUARY GAVE WEEKS TO RESPOND
TO THAT RFI.
AS OF TODAY THE IMPLEMENTATION
WORKING GROUP IS 20 MEMBERS FROM
ACROSS THE EXTRAMURAL INSTITUTE
AND THERE ARE SUBGROUPS.
THE FIRST SUBGROUP IS STRATEGIC
PRIORITIES, OUTCOMES AND
REPAYMENT.
THE SECOND SUBGROUP IS COMMUNITY
AND DIVERSITY TRAINING THEN THE
THIRD SUBGROUP IS THE
INSTITUTIONAL TRAINING AND
CAREER DEVELOPMENT.
I'M LUCKY TO BE A CO-LEAD OF
THIS GROUP WITH OTHERS.
THE FIRST SUBGROUP IS STRATEGIC
PRIORITIES, OUTCOME AND LOAN
REPAYMENT.
THE SECOND SUBGROUP IS COMMUNITY
AND DIVERSITY HOW TO BUILD A
COMMUNITY OF NICHD TRAINEES AND
CREATE THAT NICHD IDENTITY AND
THEN THE THIRD SUBGROUP LED BY
SUSAN IS THE T32 AND K12 GROUP
AND IT'S THE CADENCE THE GROUP
MEETS ONCE A MONTH AND SUBGROUP
MEETINGS EACH MONTH AND SOME
PEOPLE WHO AREN'T ON THE SLIDE
THAT SHOULD BE RECOGNIZED AS
WELL ARE CONTRACTORS SUPPORT
FROM GUIDE HOUSE.
THEY HAVE BEEN HELPFUL IN THE
PROGRAM MANAGEMENT SIDE OF
THINGS AND THEN NICHD STAFF LIKE
JASMINE AND ASHLEY BARNES HAVE
HELPED KEEP ON TRACK OF
SCHEDULING.
SO WHAT I'D LIKE TO DO NOW IS
BRIEFLY HIGHLIGHT WE'VE ONLY A
COUPLE MONTHS UNDER OUR BELT BUT
HAVE COME UP WITH IDEAS HOW TO
MOVE FORWARD AND SET HIGH
PRIORITY GOALS AND LOWER
PRIORITY GOALS AND WE'RE WORKING
THROUGH THAT.
FOR THE FIRST SUBGROUP REMEMBER
THIS SUBGROUP HAS THEE
RECOMMENDATIONS AND THERE'S ONLY
11 ACTION ITEMS.
SO TWO ACTION ITEMS ARE TO
EXPAND THE LOAN REPAYMENT
PROGRAMS TO INCLUDE THE L32
FUNDING MECHANISM.
THAT'S CLINICAL RESEARCH FOR
INDIVIDUALS FROM DISADVANTAGED
BACKGROUNDS.
SO NICHD JOINED THAT IN LATE
2023 AND WE HOPE PENDING THE
RECEIPT OF MERITORIOUS
APPLICATIONS TO LOOK AT THAT AND
THE SELECTION PROCESS TO INCLUDE
REPRESENTATION FROM OUR OFFICE
OF HEALTH EQUITY AND THE
TRAINING COMMITTEE TEAM.
JUST TO HIGHLIGHT ONE OF THE
ITEMS THAT'S IN PROGRESS IS TO
TRACK AND ENCOURAGE IMPORTANT
CAREER TRAJECTORIES TO BE ABLE
TO TRACK THE OUTCOMES OF PEOPLE
WHO WE'VE SUPPORTED OVER THE
YEARS NOT JUST THROUGH WHAT
GRANTS THEY'VE GOTTEN BUT THEIR
CAREER OUTCOMES.
SO, THE SECOND GROUP IS A GROUP
I'VE BEEN INVOLVED WITH A LOT IS
THE COMMUNITY AND DIVERSITY
SUBGROUP AND WE'RE COMING UP
WITH WAYS TO CREATE COMMUNITY
AMONGST TRAINEES AND TO
DIVERSIFY NICHD'S REACH IN THE
TRAINING COMMUNITY.
ONE THING WE'VE DONE SO FAR IS
TO HAVE THE OFFICE OF HEALTH
EQUITY DEVELOP A SYSTEMATIC
PROCESS FOR EVALUATING AND
SIGNING ON TO DIVERSITY-FOCUSSED
NOTICES OF FUNDING OPPORTUNITY
OR NOFOs.
THE IDEA IS THERE'S A GROUP OF
COMMITTEE OF STAFF FROM ACROSS
THE INSTITUTE WHO CAN LOOK AT
FUNDING OPPORTUNITIES THAT ARE
NOT FOCUSSED ON A SPECIFIC
SCIENTIFIC AREA BUT THE TRAINEES
COULD BE IN ANY SCIENTIFIC AREA
THAT'S SUPPORTED BY US AND TO
MANAGE THE PART PASSION IN THOSE
OPPORTUNITIES.
THERE'S A LOT OF THINGS IN
PROGRESS.
SOME ARE FURTHER ALONG THAN
OTHERS.
WE'RE LOOKING AT HOSTING
WORKSHOP FOR FELLOWSHIP TRAINEES
AT NICHD.
WE'D LIKE TO CREATE A
DISTRIBUTION LIST OF SCHOLARS
WHICH IS SURPRISINGLY
COMPLICATED AND TO ADVERTISE
NICHD WIDE EVENTS, FUNDING
OPPORTUNITIES, MAYBE THROUGH A
NEWSLETTER OR SOMETHING LIKE
THAT AND TO DO EQUITABLE
OUTREACH ACROSS INSTITUTIONS TO
INCREASE THE NUMBER OF
APPLICATIONS OF INSTITUTIONS
WITHOUT SIGNIFICANT NICHD
FUNDING.
ONE WAY WE DO THAT IS THROUGH
OUTREACH AND SCIENTIFIC
CONFERENCES, SCIENCE CONFERENCES
AND MORE FOCUSSED CONFERENCES.
FINALLY, THIS GROUP GETS A LOT
OF INTEREST HOW WE SUPPORT K12s
AND P32s AT NICHD.
AND SO ONE OF THE THINGS WE'VE
ACCOMPLISHED AND THIS
ACCOMPLISHMENT I'LL TALK ABOUT
IS TO ESTABLISH A DIFFERENTIAL
PAY LINE FOR NEW VERSUS RENEWAL
PROGRAMS BUT I THINK A WAY TO
THINK ABOUT IT IS THAT THE SCORE
THE APPLICATION GETS IS ONE
PIECE OF INFORMATION.
IF YOU JUST LOOK AT THE NUMBER
THE APPLICATION GETS, THE SCORE
YOU'RE LEAVING OUT A LOT OF
OTHER INFORMATION THAT CAN BE
USEFUL IN COMING UP WITH
FUNDING.
SOME OF THE ACTION ITEMS IN
VARIOUS STAGES OF PROGRESS IS TO
CONSIDER THE POSSIBILITY OF
CLUSTERING NEW AND RENEWAL T32
APPLICATION SEPARATELY IN PEER
REVIEW SO RENEW APPLICATIONS ARE
COMPARED TO RENEWALS AND THE
LAST ONE IS AN EVALUATION METRIC
TO HELP DECIDE WHEN CAN A K12
DECLARE VICTORY.
HAS IT DEVELOPED A COMMUNITY OR
SHOULD THESE PROGRAMS GO ON FOR
LONG PERIOD OF TIME AND WE'RE
NOT SUGGESTING TERM LIMITS FOR
K12.
WE'RE SUGGESTING AS WHEN K12
PROGRAMS ARE RENEWED EITHER
THROUGH APPLICATIONS OR NOFOs
THERE'S JUSTIFICATION MADE.
FINALLY THE LAST THING I WANT TO
TALK ABOUT IS OUR REQUEST FOR
INFORMATION.
WE PUBLISHED THE RFI AT THE END
OF FEBRUARY AND THE RESULTS CAME
IN IN EARLY MAY.
SOME OF THIS IS RELATIVELY FRESH
BUT WE'VE DONE INITIAL ANALYSIS
AND WE WOULD HAVE LIKED TO HAVE
GOTTEN A FEW MORE RESPONSES AND
SEVEN RESPONSES WERE FROM
INDIVIDUALS AND SIX WERE ON
BEHALF OF GROUPS EITHER INTEREST
GROUPS OR ACADEMIC INSTITUTIONS.
THE GROUPS OR INSTITUTIONS
REPRESENTED THREE WERE PROVIDERS
AND I WOULD INCLUDE HOSPITALS IN
THIS GROUP.
ACADEMIC INSTITUTIONS AND FOUR
SPECIAL INTEREST GROUPS AND THE
PRIZES WERE ANONYMOUS SO WE
WON'T BREAK IT UP.
DESPITE ONLY HAVING 13 RESPONSES
EACH OF THE SIX GOALS THAT WERE
TALKED ABOUT IN JANUARY COUNCIL
RECEIVED RFI RESPONSES.
PEOPLE COMMENTED ON THOSE WHEN
YOU WENT THROUGH THE RESPONSES
THEMSELVES.
YOU CAN SEE THERE'S ONE OUTLIER.
PEOPLE WERE VERY EXCITED TO TALK
ABOUT THE RT32 AND K12 PROGRAMS
AND HOW WE SUPPORT THEM.
THERE WERE SOME THINGS THAT I
THINK WILL HELP US GOING FORWARD
AS YOU CAN IMAGINE HAVING TERM
LIMITS FOR TRAINING GRANTS WAS
NOT A POPULAR OPTION.
AND SO THAT'S SOMETHING THAT WE
WOULD CONSIDER MOVING FORWARD OF
COURSE BUT MANY EVERY ONE OF
THESE TOPICS GOT SOME FEEDBACK.
SO WHAT WE DID IS WORKED WITH
THE GUIDE HOUSE TEAM TO TRY TO
COME UP WITH ACTIONABLE ITEMS WE
COULD THINK ABOUT AS WE MOVE
FORWARD IN OUR IMPLEMENTATION
PLAN.
FOR EXAMPLE IN RETHINKING HOW WE
TALKED ABOUT OUTCOMES.
WE GOT LOTS OF EXAMPLES FOR
METRIC FOR DETERMINING A
SUCCESSFUL RESEARCH CAREER.
FOR REINVIGORATING INSTITUTIONAL
AND CAREER DEVELOPMENT PROGRAMS.
THERE WAS TALK ABOUT WAYS THERE
COULD BE PARTNERSHIPS BETWEEN
INDIVIDUAL INSTITUTIONAL
PROGRAMS AND HOW THAT COWL BE
USED IN A SYNERGISTIC WAYS TO
MAKE THE PROGRAMS BETTER.
TO CREATE A COMMUNITY AMONGST
TRAINEES TO PERHAPS COME UP WITH
FORMAL OPPORTUNITIES FOR
TRAINEES TO ANTIACT AND GET
OTHERS SUPPORTED BY NICHD TO THE
LONE REPAYMENT PROGRAM.
AND I NOUTH THIS WAS INTERESTING
TO USE THE TRAINING AND CAREER
DEVELOPMENT TO SUPPORT STRATEGIC
RESEARCH INITIATIVES OF THE
INSTITUTE TO PERHAPS FIGURE OUT
WAYS TO LINK TRAINING NETWORKS
TO EXISTING RESEARCH NETWORKS
AND EMPHASIZE MULTI-DISCIPLINARY
TEAM SCIENCE COMPONENTS OF THE
GRANTS.
AND WE LOOK AT SOME OF THE
FINDINGS AND TALK ABOUT WORK
HEARING FROM TRAINEES THEMSELVES
ABOUT WHAT THEIR CHALLENGES AND
OPPORTUNITIES ARE BUT THANK YOU.
>> GOOD MORNING AND THANK YOU TO
THE NICHD TEAM AND I'M LESLY
SAMEDY BATES.
IS THIS IS SPONSORED BY THE
THERAPEUTICS BRANCH AND WE HOPE
TO SHARE INFORMATION WITH YOU
ABOUT THE TRAINEES PERSPECTIVES
AND MAYBE WE KCAN INVIGORATE TH
APPROACH TO TRAINING AND
TRAINEES' EXPERIENCE.
I'LL BE OFFERING BRIEF
INFORMATION BEFORE MOVING ON TO
THE HIGHLIGHT OF THE DISCUSSION
AND RESULTS OF OUR SURVEY.
I'LL ALSO SHARE PLANS FOR
UTILIZING THE SURVEY FINDINGS
AND DISCUSS THE FUTURE DIRECTION
OF OUR TRAINING PROGRAM.
THE TRAINING NETWORK IN 2011 IN
RESPONSE TO THE BEST
PHARMACEUTICALS FOR CHILDREN ACT
BPCA, IT REQUIRED PEDIATRIC
PHARMACOLOGISTS TO BE INCLUDED
IN EXISTING NIH CAREER
DEVELOPMENT PROGRAMS.
THE NETWORK WAS NATIONALLY A
CO-FUNDED PROGRAM IN PEDIATRIC
PHARMACOLOGY ALONGSIDE NIGMS AND
NIH.
AND IT'S NOW TRANSITIONED TO A
NICHD-ONLY FUNDED NETWORK
HOWEVER, THE TOOLS AND RESOURCES
ARE FOR ALL INTERESTED TRAINEES.
SEVERAL FELLOWS STILL
PARTICIPATE FROM OTHER
INSTITUTES AND I THINK THIS
TELLS US ABOUT THE BIGGER IMPACT
THAN ORIGINALLY ENVISIONED.
SO LISTED ARE ALL THE CURRENT
SITES OF CPTN.
IN BLUE WE HAVE T32
INSTITUTIONAL PHARMACOLOGY
SITES.
IF THE PINK SITES NEWLY MINTED
CAREER DEVELOPMENT PROGRAM AND
IN YELLOW SITE WE CONSIDER
AFFILIATE SITES.
THEY MAY NOT HAVE A TRADITIONAL
PHARMACOLOGY PROGRAM OR COME IN
THROUGH THE CLINICAL
PHARMACOLOGY NOFO.
THE SITES IN YELLOW INCLUDE
LOCATIONS FOR OUR PREDOCTORAL
AND POST-DOCTORAL INDIVIDUAL
FELLOWS AND.
K99 FELLOWS.
AND I WANTED TO A SHARE WITH THE
AFFILIATE SITE.
THEY BRING MORE DIVERSITY IN
TERMS OF BACKGROUND INTO THE
NETWORK.
FOR EXAMPLE WE HAVE AN F32
FELLOW WHERE THEIR FIRST FOCUS
IS SURGERY AND MEDICAL DEVICES.
I WOULD LIKE TO HIGHLIGHT CPTN
IS REPRESENTED ACROSS THE
CONTINENTAL U.S. AND RECOGNIZE
THE OPPORTUNITY TO EXPAND OUR
REACH AND PERHAPS CONNECT WITH
MORE RURAL STATES LIKE SOUTH
DAKOTA, INDIANA AND WYOMING.
SO CURRENT NETWORK IS COMPRISED
OF THE COMPONENTS YOU SEE HERE.
THEY'RE ALL GEARED TOWARDS
DELIVERING A COMPREHENSIVE
TRAINING EXPERIENCE.
I THINK OUR LECTURE SERIES MAY
BE THE MOST POPULAR COMPONENT OF
OUR NETWORK DESIGN TO CATER THE
EDUCATIONAL NEEDS OF CLINICAL
PHARMACOLOGY STUDENTS WHO MAY
LACK A FORMAL CURRICULUM AND WE
DO OFFER EXCLUSIVE WORKSHOPS FOR
OUR FELLOWS AND THESE ARE AIMED
AT FOSTERING PEER ENGAGEMENT AND
NURTURING COLLABORATION AND
TAPPING INTO THE COLLECTIVE
RESOURCES OF OUR NETWORK SITES.
WE EMPHASIZE THE VALUE OF TEAM
SCIENCE AND ENCOURAGING AND
SUPPORT UNIQUE AND INNOVATIVE
RESEARCH ENDEAVORS AND WE
ENCOURAGE THAT TOGETHER THE
COMPONENTS DO OFFER A
COMPREHENSIVE TRAINING
EXPERIENCE.
SO IN ADDITION TO THE FOUR
COMPONENTS, CPTN HAS A NETWORK
THAT CONVENES AN ANNUAL MEETING
PROVIDING TRAINEES A PLATFORM TO
SHOWCASE THEIR WORK AND CONNECT
WITH OTHER FELLOW PARTICIPANTS.
WE ALSO HOLD POST ORIENTATION
MEETINGS OFFERING INSIGHTS INTO
NICHD'S KEY FIGURES, WHO IS WHO
AND HOW TO NAVIGATE THE NIH
LANDSCAPE.
AGAIN, I'M EXCITED TO SHARE THAT
WE'VE INTRODUCED OUR NEW K12
CAREER DEVELOPMENT INITIATIVE
RUNNING WITH OUR POST-DOCTORAL
ARM.
WE DO TAKE GREAT PRIDE IN OUR
ALUMNI NETWORK.
THEY'RE ACTIVE IN OUR NETWORK
EVENTS AND PARTICIPATE IN ALL OF
OUR ENGAGEMENT.
I WILL SAY CPTN SERVES AS A
VITAL LINK IN CONNECTING
TRAINEES WITH OTHER NICHD
NETWORK LIKE MANY MPRINT AND PTN
AND CONNECT WITH OTHER AGENCIES
AND INDUSTRY PARTNERS AS WELL.
HOW DO WE MAKE MODIFICATIONS AND
IMPROVEMENTS?
THIS IS WHERE THE SURVEY COMES
INTO PLAY.
OVER THE PAST FEW YEARS WE
RECOGNIZED THE NECESSITY FOR
CHANGE DRIVEN BY THE INSIGHT AND
INITIATIVES OF OUR FELLOWS.
WE HAVE CHIEF FELLOWS AND
THEY'RE ENCOURAGED TO LEAD ONE
PROJECT AIMED AT ENHANCING THE
NETWORK.
LAST YEAR OUR CHIEF FELLOWS
CREATED, DISSEMINATED AND NOW
EVALUATING THE RESULTS OF THEIR
FELLOW SURVEY.
THE INITIAL FINDINGS OF WHICH
I'LL BE PRESENTING OVER THE NEXT
FEW SLIDES.
I DID WANT TO MENTION THE SURVEY
IS ANONYMOUS AND THE ANALYSIS IS
STILL UNDERGOING EARLY STAGE
ANALYSIS.
SO THE IDEA OF THE SURVEYS BEGAN
AROUND 2022.
WE DID SPEND OUT AN INITIAL
SURVEY HOWEVER, THIS IS LIMITED
TO OUR CURRENT FELLOWS AT THE
TIME.
THIS LATEST SURVEY EXPANDED ITS
SCOPE TO ENCOMPASS CURRENT AND
ALUMNI FELLOWS AND THE OBJECTIVE
IS TO HELP GUIDE SHORT AND
LONG-TERM PROGRAMMATIC
DEVELOPMENT.
THIS HAS 17 QUESTIONS AND
RECEIVED ABOUT 85 RESPONSES.
ONLY ONE RESPONDED AS LATINO.
4% RESPONDED AS HAVING A
DISABILITY ACCORDING TO THE
AMERICANS WITH DISABILITIES ACT.
IN TERMS OF EDUCATIONAL BA
BACKGROUND, 13% HOLD A DEGREE
AND 33% HOLD A Ph.D.
I THINK IT'S IMPORTANT TO
ACKNOWLEDGE SOME OF THE
RESPONDENTS REAPPLIED TWICE
PAUSE THEY MAY HOLD A DUAL
DEGREE AND I THINK IT'S ALSO
WORTH MENTIONING THE RESPONSE
RATES TO THESE QUESTIONS VARIED
THE DEMOGRAPHIC INFORMATION WAS
SUPPLIED
I 74% OF RESPONDENTS.
THE RESPONDENTS WERE THEN ASKED
ABOUT THEIR CAREER PLANS.
WHETHER IT WAS CURRENT OR FUTURE
PLANS.
75% INDICATED A PREFERENCE
TOWARDS PURSUING CAREERS IN
ACADEMIA IT'S WORTH NOTING THE
RESPONSE REFLECTS THE CAREER
INTENTIONS OF ALUMNI FELLOWS
ALREADY ESTABLISHED IN ACADEMIA.
WHAT I THOUGHT WAS INTERESTING
WAS AMONG THE 14 CURRENT FELLOWS
ONLY ONE EXPRESSED A DESIRE FOR
ACADEMIC CAREER PATH AND WERE
ASKED TO IDENTIFY THE FACTORS
INFLUENCING THEIR CAREER
DECISION AND YOU CAN SEE HERE
WORK-LIFE BALANCE, LOCATION AND
FAMILY CONSIDERATIONS WERE AT
THE TOP OF THE CONSIDERATIONS.
SALARY, WORK ENVIRONMENT AND
RESEARCH OPPORTUNITIES ALSO HAD
NOTABLE MENTIONS.
AND WE WANTED TO SEE WHAT OTHER
THINGS MAY INFLUENCE THEIR
CAREER DECISIONS.
AND DEBT WAS A BIG HEAVY HITTER.
THIS COULD INCLUDE STUDENT LOAN
OR PERSONAL DEBT.
AND THERE WAS STRONG AND MINOR
INFLUENCE AND NO INFLUENCE
CATEGORIES.
AND RESPONDENTS WERE ALSO
QUESTIONED ABOUT THE LEVEL OF
SUPPORT FELT IN THEIR CAREER
PATHS.
AGAIN, IT WAS AN EVEN
DISTRIBUTION ACROSS CATEGORIES
THOUGH WE DO ACKNOWLEDGE THE
VECT SELECTIVE SUPPORT WAS
NOTABLY HIGHER AND DEFINED
SELECTIVE SUPPORT AS BEING
SUPPORTIVE IN ONE AREA OR ONE
ASPECT OF THEIR CAREER PLANS AND
NOT IN OTHER AREAS.
RESPONDENTS WERE SURVEYED
WHETHER THEY FELT OPPORTUNITIES
EXISTED WITHIN THE CLINICAL
PHARMACOLOGY FIELD.
THE OUTLOOK ON JOB PROSPECTS
APPEARED MIXED.
THEY RANKED THE AVAILABILITY OF
POSITIONS IN INDUSTRY SECTOR
HIGHEST AND I THINK THIS IS
LIKELY A CONSIDERATION OF LIKE
WORK-LIFE BALANCE AND
OPPORTUNITIES.
SO NEXT BASED ON THE SURVEY
EXPLORED THE TRAINEES'
PERCEPTION OF TRAINING IN THEIR
CAREERS.
WE INQUIRED ABOUT WHAT THEY
PERCEIVED AS HIGH NEEDS AND
INQUIRED WHAT THEY PERCEIVE AS
BARRIERS.
I WANT TO SHARE A SIMPLE
REPRESENTATION OF THE TRAINING
NEEDS FIRST.
HERE'S A GRAPH OF THE RESPONSES
TO THE NEEDS QUESTION.
YOU CAN SEE I THINK THERE'S A
WIDE RANGE OF RESPONSES.
WHAT YOU SEE IN THE DARK GREEN
AND LIGHT GREEN BARS ARE GRANT
WRITING AND FUNDING AND EMERGE
AS THE MOST PROMINENT NEEDS AND
MENTORSHIP AND DIDACTIC PROGRAMS
WERE RANKED LOWER.
BACK TO THE PREVIOUS SLIDE WHEN
IT COMES TO TRAINING NEEDS, THE
TRAINEES EXPRESSED A DESIRE FOR
DEARLY RESOURCES AND APPLYING
FOR FUNDING OPPORTUNITIES AND
PREPARATION FOR ENTRY IN THE
WORKFORCE AND ALSO HIGHLIGHTED A
NECESSITY FOR ENHANCED
MENTORSHIP AND PRESENCE OF ROLE
MODELS.
INTERESTINGLY THE RESPONDENTS
HIGHLIGHTED THE INADEQUATE
MENTORSHIP AND RANGED -- RANKED
MENTORSHIP LOWER AND THE
PERCEIVED TRAINING IN TRAINEES
AND I THINK THE CHIEF CITATION
WAS THE LIMITED TIME AVAILABLE
AND AGAIN MENTIONED INADEQUATE
MENTORSHIP AND SHORTAGE OF
FUNDING.
TRAINEES EXPRESSED THEIR
FEELINGS OF UNCERTAINTY
REGARDING THEIR CAREER
TRAJECTORY AND I THINK THEY
MENTIONED IT SEEMED ON THE MINOR
END.
AND I THINK THIS ENCOURAGES US
AND SHOWS US THERE'S OPPORTUNITY
FOR IMPROVEMENT IN THE TRAINING
EXPERIENCE IN TERMS OF
INCREASING MENTORSHIP AND MEN
THE ROLE MODELS AVAILABLE AND
PROVIDING ASSISTANCE WITH
APPLYING FOR FUND IING AND ASSI
AN IN APPLYING FOR JOBS.
WE REGULARLY REVIEW OUR
STRENGTHS AND DO AN ANNUAL
OPPORTUNITY FOR CURRENT AND
FORMER ALUMNI TO SUBMIT FEEDBACK
AT THE END OF THE YEAR, AT AND
THE OF OUR WORKSHOPS AS WELL AS
THE END OF OUR LECTURE SERIES.
THERE'S SOME QUOTES I WANTED TO
SHARE WITH YOU ALL.
AND BUILDING A NICHE OF THE
PEDIATRIC RUHEUMATOLOGISTS IN TE
U.S. AND WE HAD A SECOND-YEAR
FELLOW REGARDING A MEETING
STATED THEY WOULD HAVE LIKED TO
HAVE HAD EARLIER SESSIONS IN
THEIR FELLOWSHIP BECAUSE THEY
FOUND THE SESSIONS TO BE
VALUABLE.
SO OVER TIME WE IMPLEMENTED
SIGNIFICANT ENHANCEMENTS TO THE
NETWORK BASED OFF THE FEEDBACK
AND WE OBSERVED GROWTH IN THE
RANGE OF OUR OFFERINGS WITHIN
THE NETWORK AND THE NUMBER OF
PARTICIPANTS INVOLVED.
I WANTED TO SHARE WITH YOU WHAT
WE PLAN TO DO WITH SOME OF THE
FEEDBACK WE RECEIVED.
IN TERMS OF TRAINING WANT TO
OFFER DISTINCTIVE TRAINING
EXPERIENCES.
WE WANT TO STRENGTHEN JOB
READINESS RESOURCES POTENTIALLY
EXPLORING THE TOOLBOX.
WE WANT TO ADDRESS PERSONAL
NEEDS AND RELATED CONCERNS.
WE ARE ENCOURAGE OUR TRAINEES TO
APPLY FOR THE NIH LOAN REPAYMENT
PROGRAM AND OFFERING GUIDANCE ON
THE APPLICATION PROCESS VIA
NIH'S WEBSITE.
WE DO WANT TO EXPLORE THE
POSSIBILITY OF CONDUCTING AN
INTERNAL SURVEY WITH
STANDARDIZED CORE QUESTIONS TO
HELP FACILITATE MORE
LONGITUDINAL ANALYSIS.
SO MAYBE WE'LL HAVE SOMETHING
MORE IN THE NEXT COUPLE YEAR.
I WANT TO ACKNOWLEDGE OUR RECENT
FELLOW MOREL AND DR. HORNIG AND
THE ADVISER FOR THE
CONTRIBUTIONS TO THEIR ANALYSIS
AND PLEASE BE ON THE LOOK OUT
FOR THAT AND I'D BE HAPPY TO
SHARE.
I HOPE THE INFORMATION WAS
HELPFUL AND INSIGHTFUL AND I
WANT TO THANK YOU FOR YOUR TIME
AND ATTENTION.
>> I WANT TO EMPHASIZE LOAN
REPAYMENT I CALLED OUT AND
EXPLORING IT.
IT'S CRUCIAL FOR PEOPLE TO
CHOOSE A CAREER IN THIS AREA.
THAT'S THE NUMBER ONE THING WE
HEAR WHEN WE TALK WITH OUR
SCHOLARS IS THEY CAN'T AFFORD A
CAREER IN RESEARCH.
LOAN REPAYMENT GOES A LONG WAY
AND WANTED TO CALL OUT ANOTHER
GREAT IDEA ON THE SCREEN AND
LESLIE TALKED ABOUT IT IN HER
TALK AS WELL.
IF YOU LOOK AT THE T AND K
SCHOLARS AND MAYBE EARLY STAGE
INVESTIGAT
INVESTIGATORS PEOPLE TO LIFT UP
A WIN-WIN SITUATION FOR BOTH
SCHOLARS AND NETWORKS BUT TO DO
THAT WE WOULD HAVE TO CONSIDER
SOME CORE PRACTICES TO CREATE
CURRICULAR AND PEER AND NEAR
PEER MENTORING NETWORK.
HOW DO WE CREATE THOSE PILOTS
AND CREATE THE CORE
INFRASTRUCTURE TO LINK THE T AND
K AND EARLY STAGE INVESTIGATORS
TO EXIST IING NICHD NETWORKS.
IT SEEMS THAT WOULD BE A
MULTIPLIER EFFECT.
>>
>> THIS COULD BE A MODEL FOR THE
BROADER THINGS WE WOULD LIKE TO
DO AND A LESSON.
WE'RE TRYING TO DEVELOP THE
INFRASTRUCTURE AND IT'S
SOMETHING WE'RE THINKING ABOUT
AND TRYING TO WORK TOWARD.
>> I RECOMMEND THAT IS TO
ARTICULATE WHAT THE FUNDING LOOK
LIKE TO CREATE THE
INFRASTRUCTURE BRIDGE BECAUSE I
THINK THE RETURN ON INVESTMENT
WOULD BE TERRIFIC.
>> THANK YOU FOR THE
PRESENTATION AND KUDOS FOR
GETTING ALUMNI FEEDBACK BECAUSE
THAT'S INCREDIBLY IMPORTANT.
OFTEN THE TRAININGS IN THE
SITUATION GIVE FEEDBACK BUT
DON'T KNOW WHAT THEY NEED YET.
THAT COUPLE YEARS OUT FROM THE
ALUMNI IS IMPORTANT.
AND ALSO I THINK THE MOST
IMPORTANT THING IS REGULAR
SURVEY AND THE ONGOING SURVEY
AND RE-REALIZATION.
I'M HAPPY TO SEE THAT.
THE OTHER THING I WAS THINKING
ABOUT WITH YOUR NETWORK IS WE'RE
MOVING INTO A NEW GENERATION OF
TRAINEES WITH THIS GEN Z GROUP.
IT MAY BE REALLY IMPORTANT TO
THINK HOW YOU CAN BE TRANSPARENT
ABOUT WHAT A NETWORK OR TRAINING
PROGRAM CAN PROVIDE AS WELL AS
WHAT A NETWORK OR TRAINING
PROGRAM CAN'T PROVIDE SO THEY
HAVE VERY CLEAR INFORMATION AND
YOUR SETTING EXPECTATIONS FROM
THE GET GO.
AND THE LAST THING I WANTED TO
DO IS ECHO SHERRI'S COMMENT AND
THINK ABOUT OF NETWORKS BEYOND
NICHD BECAUSE THERE'S SO MANY
TOPICS FUNDED BY OTHER AGENCIES
THERE MAY BE A WAY TO CONNECT
TRAINEES WITHIN THE NETWORKS
OUTSIDE THAT COULD IMPROVE
NETWORKS AND TRAINEES OPTIONS.
>> WHEN YOU LOOK AT THE WORD
CLOUD FOR THE CURRENT
GENERATION.
ONE OF THE QUESTIONS I HAD IN
THE NEEDS ASSESSMENT WAS A
LITTLE HARD TO TELL BY HOW IT
WAS PRESENTED WHETHER THESE ARE
THINGS THAT THEY WANTED AND
WEREN'T GETTING OR WHETHER THESE
ARE THINGS OF WHAT THEY'RE
GETTING THAT ARE REALLY
IMPORTANT AND I THINK IT WOULD
BE IMPORTANT TO SORT OF FIGURE
OUT AND MAYBE IT'S OBVIOUS TO
YOU FROM THE QUESTION BUT GRANT
AND FUNDING, IT SEEMS LIKE THAT
MAY BE A LOT OF WHAT IS
HAPPENING AT THE TRAINING GRANT
AND GETTING IT AND HAPPY ABOUT
IT OR FEEL THEY NEED IT AND NOT
HAPPY ABOUT IT.
I THINK THEY'RE MAKING SOME
PROGRAMS DOING THAT WELL AND
SOME NOT DOING THAT WELL.
ONE PROGRAM CAN LEARN FROM
ANOTHER SO IT WAS HARD FOR ME TO
ASCERTAIN WHETHER THESE WERE
THINGS THEY WANT AND NOT GETTING
OR WANT AND THEY ARE GETTING AND
THINK SHOULD BE PRIORITIES FOR
THE PROGRAM.
>> THANK YOU.
THAT'S SOMETHING WE HAD TALKED
ABOUT TRYING TO DISCERN WHAT THE
RESPONSE OF THAT QUESTION MEANT
AND THAT'S WHAT PROMPTED US TO
HAVE CORE QUESTIONS DEVELOPED BY
NICHD STAFF SO WE COULD CLEARLY
GET AN IDEA OF WHAT ARE ALUMNI
FELLOWS ARE LOOKING FOR.
A OBSERVATION.
I DON'T WANT TO ASSUME I KNOW
WHAT THEY MEAN BY THAT BUT I'LL
LOOK INTO THAT QUESTION MORE AND
INTO THE FUTURE MAKE SURE WE
HAVE A BETTER WAY OF DISCERNING
THE RESPONSES TO THAT.
>> SO IF I COULD JUST ADD WE HAD
A NICE CONVERSATION WITH THAT
AND LOOKED LIKE THREE-QUARTERS
OF TRAINEES WANT TO GO INTO
ACADEMIA BUT ONLY A QUARTER PLAN
TO GO INTO HAD ACADEMIA OR
SOMETHING LIKE THAT.
>> JOE, THERE'S A QUESTION AND
THEN AN ONLINE QUESTION FROM
GENEVIEVE.
>> THANK YOU BOTH FOR THESE VERY
INTERESTING PRESENTATIONS.
MY QUESTION IS RELATED JUST TO
THE LAST POINT YOU MENTIONED HOW
THERE'S A DIFFERENTIAL BETWEEN
THE CURRENT TRAINEES IN THESE
PROGRAMS AND THEIR CAREER
CHOICES OR WISHES AND THE ONES
THAT HAVE GRADUATED.
SO THIS IS NOT UNIQUE I THINK TO
NICHD PROGRAMS.
WE SEE IT ACROSS OTHER
INSTITUTIONAL TRAINING AND
SCHOLAR DEVELOPMENT PROGRAMS.
SO I'M CURIOUS HOW MUCH YOU LOOK
AT MORE GLOBALLY THE TRAINING
AND WHETHER YOU THINK IN TERMS
OF LOOKING AT DIFFERENT OUTCOMES
MORE PRACTICALLY.
WHAT DOES THAT LOOK LIKE?
>> ONE OF THE THINGS I WOULD SAY
IS THAT I THINK IT'S SOMETHING
THAT'S REALLY CHANGED IN THE
LAST 20 YEARS OR SO IS THERE
USED TO BE A HIERARCHY OF
OUTCOMES AND NOW IT'S A MORE
LEVEL PLAYING FIELD WHERE PEOPLE
HAVE EQUAL OPTIONS OPPOSED TO IF
I DON'T DO THIS I'LL DO THIS OR
THIS.
SO IN A WAY MAYBE IT'S GOOD
PEOPLE -- THE PIE CHART SHOWED
FIVE THINGS PEOPLE WERE
INTERESTED IN DOING.
THAT'S A GOOD THING.
THERE AREN'T ENOUGH JOBS IN
ACADEMIA AT LEAST LAST TIME I
CHECKED TO FOR ALL THE
TRAININGS.
>> A QUICK FOLLOW UP ON THAT,
WHAT'S INTERESTING IS IT SEEMED
LIKE IT'S A HUGE SHIFT FROM 75%
FROM ORIGINALLY PLANNED TO ONE
PERSON LITERALLY NOW.
UNDERSTANDING THAT --
>> UNDERSTANDING THAT SPECIFIC
CHANGE SEEMS TO BE QUITE
IMPORTANT FOR THE FUTURE OF
ACADEMIA.
EVEN IN THE CONTEXT OF HAVING
MORE OPTIONS.
>> RIGHT.
>> I WILL MENTION IN SOME OF OUR
FELLOW WORKING WORKSHOPS OUR
FELLOW ONLY WORKSHOPS IT SEEMS
LIKE ACADEMIA IS HAVING TO
COMPETE WITH INDUSTRY.
VERY HEAVILY WHAT WE'VE SEEN
OVER THE LAST COUPLE YEARS.
OUR FOCUS IS TO EVALUATE THAT
QUESTION A LITTLE BIT BETTER IN
TERMS OF WHAT SPECIFIC THINGS
ARE LEADING YOU AWAY FROM
ACADEMIA OR DRAWING YOU TO
ACADEMIA.
DEFINITELY KEEP IN MIND WE HAVE
TO EVALUATE OR INVESTIGATE THIS
A LITTLE BIT MORE.
>> WE'RE GOING TO TAKE ONE LAST
QUESTION BEFORE GENEVIEVE NEIL
PERRY.
>> I WANT TO ELEVATE THIS AS A
PERSON OF COLOR WHO BENEFITTED
FROM IT I WOULD PROBABLY WOULD
HAVE GONE A GIVEN ROUTE WITHOUT
IT SO IT'S AN IMPORTANT PART OF
WHAT'S HAPPENING.
I WAS A BIT SURPRISED BY THE
RESPONSE RATE.
I WONDER HOW WAS THE RFI DONE
AND I'M CONCERNED THERE ARE 13
RESPONSES AND THEN WE'RE MAKING
DECISIONS POTENTIALLY ON BASED
ON 13 RESPONSES.
>> I MEAN I WISH I KNEW THE
ANSWER TO THAT.
IT WAS IN THE DIRECTOR'S LETTER
AND LINKED IN AND FACEBOOK.
WE HAD OUR STAFF SHARE THIS
INFORMATION WITH THEIR GRANTEES
AND APPLICANTS.
SO, IF YOU HAVE IDEAS, PLEASE.
>>
>> I DO HAVE IDEAS.
I RECOMMEND WORKING DIRECTLY
WITH SOME OF THE PROGRAM
DIRECTORS AND THE P.I.s BECAUSE
THAT IS HOW YOU ARE GOING TO
LIKELY GET RESPONSE.
PEOPLE ARE INUNDATED WITH
E-MAILS.
THEY BECOME DESENSITIZED AND
THAT'S REALLY SIMPLY A FACT AND
REALLY CREATING A NETWORK JUST
LIKE WE'RE TALKING ABOUT IN
TERMS OF TRAINEES A NETWORK TO
GET THE MESSAGE OUT AND THE
RESPONSE I THINK THAT WOULD BE A
REALLY AN EFFECTIVE WAY TO DO
IT.
AND I ALSO JUST WANTED TO ECHO
DAMIEN'S COMMENTS BECAUSE I'D
LIKE TO KNOW IF THEY'RE NOT
GOING INTO ACADEMICS WHAT ARE
THEY DOING?
AND THE OTHER PIECE I THINK
THERE MAY BE DISMISSIVE
INFORMATION OUT THERE ABOUT
WORK-LIFE BALANCE AND
UNDERSTAN
UNDERSTANDING A LITTLE BIT ABOUT
WHAT THAT MEANS BECAUSE EVEN IF
THEY WORK IN THE PHARMACEUTICAL
INDUSTRY THEY'RE GOING TO BE
SOME LATE NIGHTS.
SO JUST A REALITY CHECK.
>> YEAH.
>> WELL, HAVE YOU VERY MUCH LOWE
AND LESLY FOR THE PRESENTATION
AND THE COMMITTEES FOR THE WORK
YOU'RE DOING IN THIS IMPORTANT
AREA.
AND THANKS TO THE COUNCIL FOR
ENGAGEMENT AND GREAT QUESTIONS.
YOU'VE NOW EARNED A LUNCH BREAK
IF YOU'RE STOMACH IS IN THE
EASTERN TIME ZONE AND IF YOU'RE
IN ANOTHER TIME ZONE, COULD BE A
DIFFERENT MEAL BUT I BELIEVE WE
HAVE BOX LUNCHES READY FOR YOU.
SO YOU'RE ENCOURAGED TO TAKE
THEM AND WE HAVE AN HOUR UNTIL
WE COME BACK ONLINE SO IT'S A
RELATIVELY CIVILIZED LUNCH
BREAK.
YOU CAN CHECK YOUR E-MAIL.
WE'RE GOING TO RETURN HERE AT 12:45 FOR A GREAT PRESENTATION. THANK YOU.
>> IT'S MY GREAT PLEASURE TO
INTRODUCE OUR NEXT SPEAKER,
ANOTHER ITALIAN NAME, DR
DR. SIMMONI PART OF OBSSR --
DR. SIMONI, SHE BRINGS MORE THAN
25 YEARS OF EXPERIENCE AS A
CLINICAL PSYCHOLOGY RESEARCHER
LOOKING AT POPULATIONS SOCIALLY
MARGINALIZED INCLUDING PERSONS
WITH HIV AND OTHER CHRONIC
ILLNESSES, LATINEX, LGBT AND
INDIGENOUS PEOPLES AND WAS A
PROFESSOR AND DIRECTOR OF
CLINICAL TRAINING IN THE
DEPARTMENT OF PSYCHOLOGY AT THE
UNIVERSITY OF WASHINGTON.
SO AS I MENTIONED BEFORE, SHE'S
PART OF THE SEATTLE MIGRATION.
SHE AUTHORED MORE MAN THAN 300
PUBLICATIONS AND TELL US ABOUT
EFFORTS TO ADVANCE AND
COORDINATE BEHAVIORAL AND SOCIAL
SCIENCES RESEARCH AT NIH WORKING
CLOSELY WITH NIH INSTITUTES AND
CENTERS AND WE'RE VERY GRATEFUL
FOR OBSSR'S SUPPORT OF A LOT OF
OUR RESEARCH.
SO PLEASE, TAKE IT AWAY.
I WANT TO TELL YOU ABOUT OUR
OFFICE AS PRIORITY.
I CAME FROM ACADEMIA SPENDING 30
YEARS OF MY CAREER IN SCHOOLS
AND DID RESEARCH IN CLINICAL
PSYCHOLOGY AND THE INTERSECTION
OF SUBSTANCE ABUSE, STIGMA,
TRAUMA, DISCLOSURE, KEY
BEHAVIORAL ISSUES IN THE FIELD
OF HIV AND I FIND MYSELF BETWEEN
THE FIELDS.
THE BIOMARKER AND INFECTIOUS
DISEASE AND HIV SPECIALIST YOU
AND BEHAVIORAL SCIENTIST AND I
WAS IN THE MIDDLE DOING
ADHERENCE RESEARCH DEALING WITH
PRESCRIPTIONS OF THE MEDS AND ME
TALKING ABOUT BEHAVIORAL THINGS.
I THINK IT'S WHAT I DO NOW.
I'M A BEHAVIORAL AND SOCIAL
SCIENCE EXPERT BUT IDEAL WITH
NIH WHICH IS PRIMARILY A
BIOMEDICAL INSTITUTION.
AND ALSO THE TIME I CAME WAS
AFTER COVID WAS BE AN IMPETUS
FOR ME TO COME AND DR. FRANCIS
COLLINS WHO SAID MAYBE WE UNDER
INVESTED IN RESEARCH ON HUMAN
BEHAVIOR.
ONE THING I'M LEARNING IS DON'T
CRITICIZE THE NIH AND I'M TRYING
NOT TO DO ABOUT THOUGHT FRANCIS
COLLINS SAID THAT HIMSELF I
THINK I'M JUST QUOTING HIM.
WE CAN ALL LEARN FROM WHAT WE
DID TO IMPROVE IN THE FUTURE.
WE HAD ORAL MEDICATIONS THAT
WERE GOOD AND COULD HAVE BEEN A
GAME CHANGE ORALLY ON TO TAKE AN
ORAL MEDICATION TO PREVENT
TAKING HIV BUT THERE WAS SUB --
STUBBORNLY UPTAKE AND STIGMA IN
THE COMMUNITY AND YOU TAKE THESE
INSTEAD OF OTHER WAYS TO TAKE
CARE OF YOUR HEALTH.
THERE WERE TRIALS MICROBIAL WAYS
OF PREVENTING HIV AMONG WOMEN
DOESN'T SEEM TO WORK.
WHY WAS THAT?
IF YOU DON'T USE THE PRODUCT YOU
CAN'T DETERMINE WHETHER IT'S
GOING TO WORK.
YOU HAVE TO HAVE BEHAVIORAL
SOCIAL SCIENCES AND SCIENTISTS
INVOLVED IN RESEARCH IN MANY
FIELD AND NOT JUST IN COVID BUT
INFECTIOUS DISEASE BUT IN TERMS
OF BEHAVIORAL AND SOCIAL SCIENCE
AND HAVING IT EVOLVE FROM EARLY
ON CAN IMPROVE HEALTH OUTCOME
AND SMOKING CESSATION PROGRAMS
AND PHYSICAL AND DIETARY
INTERVENTIONS WHICH PERFECT
UNDER LIE SIX OF THE 10 MENTAL
HEALTH PREVENTIONS AND ADHERENCE
TO MEDICAL TREATMENT.
AND I HAVE A COLLEAGUE PHYSICIAN
WHO SAID REALLY, WHEN YOU DO
ANYTHING WITH HUMAN BEINGS
THERE'S A COMPONENT TO A BIO
MEDICAL INTERVENTION THAT'S
HUMANISTIC.
ANY BIO MEDICAL INTERVENTION IS
BEHAVIORAL INTERVENTION IS BIO
BEHAVIORAL SCIENCE AND THAT'S
WHAT I TRIED TO THINK ABOUT.
SO.
THE OFFICE OF BEHAVIORAL AND
SOCIAL SCIENCES RESEARCH
INITIATED BY CONGRESS IN 1993.
WE OPENED OUR DOORS TWO YEARS
LATER WITH COORDINATING THE
SOCIAL SCIENCES AT NIH AND
IDENTIFYING CHALLENGES AND
OPPORTUNITIES TO ADVANCE THESE
SCIENCES.
THERE'S AN OFFICE OF THE AND
DPCPS I AND PLANNING AND
STRATEGIC NIFTS THERE'S 16
OFFICES AND WE'RE ACROSS THE
OFFICE OF THE DIRECTOR AND I
DUAL APPOINTMENTS AND OUR ROLE
IS TO CUT ACROSS ALL OF THESE
DIFFERENT INSTITUTES.
WE HAVE A SMALL TEAM, SMALL
BUDGET BUT BECAUSE OF THAT THE
TEAM IS THE ENERGY.
OUR STAFF IS ENERGY OF THE WORK
WE DO AT THE SOCIAL SCIENCES
OFFICE.
THEIR CREATIVITY AND DEDICATION
AND ABILITY TO NETWORK AND
ACCOMPLISH WHAT NEEDS TO BE DONE
IS WHAT MAKES US DO A LOT OF
WITH THE LITTLE BIT WE ALLOCATE.
I HAVE A DEPUTY DIRECTOR JANINE
SIMMONS A PSYCHIATRIST AND
NEUROSCIENTIST SO A GREAT
COMPLEMENT TO THE PSYCHOLOGY AND
WENDY SMITH AND ROSEALIND KING
AND KATHRYN MORRIS AND 25
FULL-TIME STAFF.
WE'RE ABOUT $41 MILLION IN
BUDGET WITH A STEADY INCREASE
OVER TIME AND MOST OUR MONEY
GOES TO RESEARCH WE COFUND WITH
OTHER I.C.s AND COME UP WITH
INITIATIVES AND WORK TO TO THE
WORK AND AND OUR FUNDING HAS
INCREASED OVER TIME WITH AN IN
COVID WHEN THE NEED WAS NEEDED
FOR THE BEHAVIORAL SCIENCES
RESEARCH.
IT'S BEEN CONSISTENTLY GROWING.
WHERE DO WE COFUND AND ALMOST
EVERY INSTITUTE IS INVOLVED IN
OUR CO-FUNDING AT NICHD AND
WE'RE PROUD TO HAVE CONTRIBUTED
OVER $3 MILLION TO THE WORK OF
THE INSTITUTE DURING THE LAST
YEAR.
YOU CAN SEE NIAID WORKED IN NIH
AND WE HAVE NEW LEADERSHIP AND
WE'RE LOOKING FORWARD TO WORKING
WITH A TEAM WITH UW ORIGINALLY
LOOKING FOUR FORWARD WITH HER
AND WANT TO MAKE SURE THE
INSTITUTES ARE SOMEONE WE
PARTNER AND WORK WITH.
AS I SAY TO OUR STAFF WE WANT TO
ENCOURAGE SOCIAL SCIENCES
RESEARCH BECAUSE WE WERE TRAINED
IN IT JUST BECAUSE WE LIKE IT,
WE THINK IT'S IMPORTANT FOR THE
OUTCOMES OF EACH OF THE
INSTITUTES AND THAT'S WHY WE
WANT TO WORK TOGETHER AND
PARTNER AND CO-FUND.
A FEW SPECIFIC GRANTS INCLUDE
THE SOCIAL MEDIATORS OF CHILD
WELL BEING AMONG ETHNIC GROUPS
AND FAMILIES AND WE'LL HEAR MORE
COMING YOU AND SOME R01s AND THE
IMPACT OF SCHOOL-BASED CENTERS
AND MY ADVISER HAD PROGRAMS SO
IT'S VERY IMPORTANT PART I THINK
OF MENTAL HEALTH CARE PROVISION
IN THE UNITED STATES.
AND THAT KINSHIP AND CHILD
HEALTH OUTCOMES IN URBAN AREAS
AND WE'RE PROUD TO BE ABLE TO
CO-SUPPORT.
A COUPLE YEARS AGO THE COUNCIL
OF COUNCIL FOR ALL NIH PUT
TOGETHER A REPORT AND LOOKED TO
WORKING GROUPS ON THE ROLE OF
BEHAVIORAL AND SOCIAL SCIENCES
AT THE NIH WHAT COULD BE DONE TO
IMPROVE IT AND MAKE IT BETTER
AND INTEGRATE IT.
SOME RECOMMENDATIONS FROM THE
COUNCIL INCLUDE STRATEGIC
INTEGRATION.
WE'RE THINKING ABOUT THE
STRATEGIC PLAN AND IT'S WELL ON
ITS WAY AND TIME TO TALK ABOUT
OUR OFFICE TO CONSISTENTLY
INCLUDE THE SSR AND THE
STRATEGIC PLANS LINKING US AND
ING THE APPLICATION AND RESEARCH
AND TRAINING SPECIFICALLY AND
INITIATIVES AND FOSTERING TEAM
SCIENCE AND DOING
INTERDISCIPLINARY INTEGRATION.
AND IN TERMS OF EXPERTISE AND
RECOMMENDATION OF REPRESENTATION
ARE GAPS IN THE NUMBER OF STAFF
AND WAYS TO INCREASE DIVERSITY
OF THE BSSR EXPERIENCE AND
ENSURING ADVISORY COUNCILS.
THIS IS THE RECOMMENDATION FROM
THE COUNCIL OF COUNCILS THAT HAD
AT LEAST TWO COUNCIL MEMBERS
WITH BEHAVIORAL HEALTH EXPERTISE
AND ENSURE THE REVIEW PANELS
REFLECT THE KNOWLEDGE AND
EXPERTISE AND HAVE A REPORT CARD
ON EVERY INSTITUTE AND WE'RE
FINDING WAYS TO MEET THE
EXPECTATIONS FROM THE COUNCIL
AND CAPACITY BUILDING.
WHAT ABOUT THE CENTERS, THE
GRANTS, THE TRIAL NETWORKS.
DO THEY HAVE CAPACITY IN BSSR.
ENGAGING EXPERTISE AND
IMPLEMENTING RESEARCH POLICIES
AND PRACTICES IN TERMS OF DATA
AND DIVERSITY AND ANALYTIC
APPROACHES TO CHARACTERIZE AND
TRACK TRENDS USING BSSR FINDINGS
TO CREATE EVIDENCE-BASED
APPROACHES TO ENHANCING THE
WORKFORCE AND SCIENTIFIC
PRACTICE.
HOW TO USE BEHAVIORAL AND SOCIAL
SCIENCES TO IMPROVE AND COME UP
WITH SCIENCE MORE EFFECTIVE,
EFFICIENT, EQUITABLE AND ETHICAL
IN TERMS OF ITS CONDUCT.
NEXT LET'S TALK ABOUT MAJOR
PRIORITIES.
WE HAVE ENOUGH TO STIMULATE AND
SEED DIFFERENT INITIATIVES SO
THREE TIMES A YEAR COINCIDING
WITH THE COUNCILS WE ASKED
DIFFERENT INSTITUTES WHAT DO YOU
NEED HELP WITH AND WHAT ARE GOOD
BEHAVIORAL SOCIAL SCIENCE YOU
DON'T HAVE MEETING YOUR PAY LINE
OR COULD USE HELP TO SUPPORT.
WE TAKE A LOOK AT THEM AND GIVE
A THOROUGH REVIEW.
IT'S ALREADY PEER REVIEWED AND
WE LOOK AT THOSE THAT FIT OUR
MISSION AND THINGS WE HOPE TO
LOOK AT.
WE HAVE RESEARCH THAT LOOKS AT
BEHAVIOR CHANGE AND HOW DO WE
CHANGE IT AND HOW DO WE MAINTAIN
THAT BEHAVIOR AND WHAT ARE THE
MECHANISMS THAT WE IMPACT.
IF YOU CAN GET SOMEONE TO ENGAGE
IN HEALTH PROMOTED BEHAVIORS
WHAT ARE THE MECHANISMS TO LEARN
WITH NEW INTERVENTIONS FOCUSSED
IN THAT AREA AND WE'RE
INTERESTED IN THE BASIC
PHYSIOLOGICAL MECHANISMS
UNDERLYING HEALTH PROMOTIONS.
AND SECOND, SOCIAL CONNECTION
AND HEALTH.
WE'VE ALL SEEN THE SURGEON
GENERAL'S REPORT ON THE PANDEMIC
OF LONELINESS AND WE'RE
INTERESTED IN THIS AND HOW IT
INTERACTS WITH SOCIAL MEDIA AND
LOOKING AT SOCIAL RELATIONS AND
DIE -- DIADS AND MECHANISMS.
TWO IMPORTANT AREAS FOR US.
AND ONE HAS TO DO WITH
MULTILEVEL RESEARCH.
LOOKING AT RESEARCH THAT
EXAMINES THE INTERSECTION OF
SOCIAL AND BEHAVIORAL INFLUENCES
ON HEALTH AT MULTIPLE LEVEL.
I WAS TRAINED AS A PSYCHOLOGIST
ONE-ON-ONE LOOKING AT THE
INDIVIDUAL.
DOESN'T REALLY CONSIDER THE
CONTEXT AS MUCH BUT WE CAN'T DO
SCIENCE LIKE THAT ANYMORE.
AND THERE WAS AN ARTICLE ON
SOCIAL SCIENCE IN MEDICINE
SAYING THE BIOLOGICAL
ESSENTIALISM SAYING IT'S ALL
BIOLOGICAL WILL IMPEDE OUR
SCIENCE.
WE NEED AN ECHO SOCIAL APPROACH
THAT LOOKS AT NOT ONLY THE
ORGANS WITHIN THE INDIVIDUAL NOT
JUST BELOW THE BELT THERE'S A
WHOLE OTHER OUTFIT THERE WITH
THE INDIVIDUAL AND THAT
INDIVIDUAL LIVES IN THE CONTEXT
AND THAT IS OFTEN FRANKLY
ENGENDERED AROUND RACIST
ENVIRONMENT.
WE NEED TO LOOK AT THOSE
FACTORS.
AND WHY SOCIAL DETERMINATES OF
HEALTH ARE SO IMPORTANT TO WHAT
WE WANT TO LOOK AT.
WE NEED TO DO THE CAREFUL
RESEARCH THAT ALWAYS HAS TO BE
LOOKED AT WITHIN THE CONTEXT OF
THE PERSON AND OF THAT
PARTICULAR ENVIRONMENT.
SO WE DON'T WANT TO DO THIS.
IT'S EASIER THAN LOOKING AT ONE
LEVEL.
YOU HAVE TO HAVE TEAM SCIENCE
AND INTERDISCIPLINARY WORK AND
LOOK AND HAVE WORK THAT IS AT
DIFFERENT LEVELS AND DIFFICULT
TO DO BUT IF YOU WANT TO HAVE
IMPACT OF THE WORK YOU HAVE TO
DO IT ESPECIALLY WHEN WE THINK
ABOUT GOING ON TO APPLICATIONS
OF THE RESEARCH WE FIND.
IT HAS TO BE EMBEDDED IN THAT
CONTEXT CAREFULLY STUDIED AND
INTEGRATE THE BSSR IS IN THE
RESEARCH AND WHEN THERE'S
TRAINING POSITION OR DO WORK AS
ON TOLL GIFT OR PEDIATRICIANS
AND YOU ADD SOMETHING.
MAYBE IT WAS WITH A NEW
INTERVENTION AND TECHNIQUE OF A
MEDICATION YOU WERE DOING AND
NOW YOU WANT TO TRAIN IN HOW TO
TALK TO THE PATIENT OR FAMILY
ABOUT THIS.
YOU DO GENETICS WORK AND HOW DO
YOU TELL THE FAMILY WHAT YOU
FOUND IF IT MAY HAVE DEVASTATING
IMPLICATIONS AND HAVE TO HAVE A
BEHAVIORAL COMPONENT TO THAT BIO
MEDICAL RESEARCH.
I LOVE THESE KINDS OF STUDIES
AND WE HAVE SEEN FOLKS DO THAT
WHETHER IT'S IN A OR ADDITION TO
WHAT'S BEING ALREADY PROPOSED IN
THE GRANT.
WE LOVE TO FUND MORE INTEGRATION
INTO BIOMEDICAL WORK.
AND FINALLY HEALTH COMMUNICATION
SCIENCE.
ANYONE MANY IN THE COVID
EPIDEMIC SAW THE IMPORTANT ISSUE
AND WHO WAS PROVIDING THE
COMMUNICATION AND HOW DO WE
UNDERSTAND IT, HOW THE
INDIVIDUALS MAKE DECISIONS ABOUT
RISK BEHAVIORS AND WHAT TO DO
WITH IT AND HAS AN IMPACT ON
DISPARITIES AND ALSO HAS TO BE
CONTEXTUA
CONTEXTUALIZED BETWEEN THE
ENVIRONMENT.
NOT JUST LOOKING AT THE ECHO
SYSTEM BUT ON PARTICULAR AREAS
OF TRUST.
EVERYTHING FROM THE DOCTOR
PATIENT RELATIONSHIP TO WHAT IS
A.I. GOING TO DO IN THE
COMMUNITY AND WHO ARE WE GOING
TO TRUST IN A.I. AND HOW DO YOU
MAKE DECISIONS ABOUT YOUR HEALTH
AND WHO COMMUNICATES THAT TO
YOU.
WE HAVE A STRATEGIC PLAN COMING
UP 2025.
WE HAD A PROCESS THAT BEGAN WELL
BEFORE I GOT HERE A COUPLE YEARS
BEFORE WE HAD ASSESSED OUR
PROGRESS AND LOOKED AT FUTURE
PLANS AND GATHERED INPUT FROM
THE RESEARCH COMMUNITY AND HAD A
COUPLE RFIs AND SPOKE WITH OUR
COORDINATING COMMITTEE AND
COLLECTED FEEDBACK AND
IDENTIFIED PRIORITIES AND
OBJECTIVES.
OUR VISION IS THE SYNERGISTIC
INTEGRATION OF SOCIAL SCIENCES
WITH BIOMEDICAL RESEARCH.
WE WANT RESEARCH WITH A
BEHAVIORAL COMPONENT AND WE
BELIEVE WILL ACCELERATE
SCIENTIFIC DISCOVERY, MORE
EFFECTIVE TREATMENT AND HEALTH
PROMOTION INTERVENTIONS AND
EQUITABLE IMPLEMENTATION
STRATEGIES THAT WILL IMPROVE
HEALTH FOR ALL AND HOW DO WE DO
THIS?
OUR MISSION IS TO ENHANCE THE
IMPACT B SSR BY IDENTIFYING
PROJECT WE THINK ARE IMPORTANT
MEETING ACROSS I.C.s AND DEVELOP
INITIATIVES AND CAN'T DO THIS
ALONE AND WORK IN PARTNERSHIP
HAVE WORKING GROUP
RECOMMENDATIONS AND COMMUNICATE
SIGNIFICANT FINDINGS AND I'M
MORE INTERESTED IN HAVING A
BROADER IMPACT IN COMMUNICATION.
I'LL BE GOING TO MORE SCIENTIFIC
MEETINGS AND HAVING A BROADER
COMMUNICATION STAFF THAT WE CAN
TALK MORE ABOUT HOW BEHAVIORAL
AND SOCIAL SCIENCES IS HELPING
THE NATION.
AND OUR PRIORITIES IN TERMS OF
RESEARCH CAPACITY AND OPERATION,
SO IN TERMS OF OUR RESEARCH
PRIORITIES THE FIRST IS
SYNERGISTIC.
WHAT I MEAN IS IT'S WITH THE BIO
MEDICAL AND BEHAVIOR AND BASIC
AND APPLIES.
EVEN IN BEHAVIORAL SOCIAL
SCIENCE YOU HAVE BASIC RESEARCH
LOOKING AT FUNDAMENTAL
MECHANISMS OF AGGRESSION OR
EMPATHY AND WHAT IT'S MEAN FOR
HEALTH INTEGRATION AND FOCUS AND
IMPACT.
WE'VE SEEN BEHAVIORAL AND SOCIAL
SCIENCE IN HIV BUT HOW DO WE
IMPLEMENT THEM.
THEY SAID THERE'S A 16 YEAR LAG
BETWEEN FINDING SOMETHING OUT
AND IMPLEMENTING AND THAT'S
OPTIMISTIC.
CAPACITY.
WE NEED TO DEVELOP AND DIVERSIFY
THE WORKFORCE AND OPERATIONAL.
WE HAVE A DEIA WIN OUR OFFICE
AND RESEARCH AND AIM TO BUILD
PARTNERSHIPS AND COLLABORATION
WITHIN NIH AND THE COLLABORATION
AND ENHANCE COMMUNICATION WITH
THE SIGN SCIENTISTS AND WIDER
PUBLIC.
EVERY INDIVIDUAL HAS A RIGHT TO
A GOOD HEALTH OUTCOME AND LOOK
AT OUR PRIORITIES AND AGAIN IN
TERMS OF THE RESEARCH THAT WE
FUND.
A COUPLE SPECIFIC INITIATIVES
THAT WE LOOKED AT IN THE BRAIN,
HUGE BRAIN INITIATIVE AT THE
NIH.
WE HAVE A SPECIFIC SUB GROUP OF
WORK IN BRAIN BEHAVIOR
QUANTIFICATION SYNCHRONIZATION.
WE SUPPORT THE VALIDATION OF
NEXT PLATFORMS AND PRECISELY
QUANTIFY BEHAVIORS TO RECORDED
BRAIN ACTIVITY.
IT'S A WAY TO LEVERAGE THE WORK
I'M GOING TO BRING TO TIE IN THE
BEHAVIORAL CONNECTIONS THAT ARE
SO IMPORTANT AND WE'RE HONORED
TO BE ASKED TO ADMINISTER $12.5
MILLION IN ADDITION TO OUR
BUDGET ALMOST A QUARTER OF OUR
BUDGET TO FUND FIREARMS
PREVENTION RESEARCH.
THE FIRST TIME CONGRESSMAN DATED
THIS AND WE'RE GOING INTO OUR
FOURTH YEAR OF FUNDING IN THIS
AREA.
AND WE'VE DONE A GREAT JOB
PUTTING UP NOFOs AND GETTING
WORK IN THAT AND ONE IS A
PREVENTION THREAT WORK AWARD.
FOR YEARS THERE WASN'T MUCH
RESEARCH THE IN PREVENTION AND
WE'RE DEVELOPING UP THE
WORKFORCE AND INFRASTRUCTURE TO
FUND THE AWARDS.
THEY'RE ACROSS THE UNITED
STATES.
AND OUR TRAINING INITIATIVES THE
WORKFORCE DEVELOPMENT IS A BIG
PART AND IN CHARGE OF OUR T32
PROGRAM AND THE TA DA PROGRAM
AND WORK IN ADVANCED DATA
ANALYTICS FOR BEHAVIORAL AND
SOCIAL SCIENCES.
WE HAVE FIVE T32 AWARDS AND
POPULATION HEALTH AND
COMPUTATIONAL AND SOCIAL SCIENCE
TRAINING AND HAVE OUR R35 SHORT
COURSES ON METHODOLOGIES AND
APPROACHES.
WE HAVE RESEARCH PROGRAMS AND
TRANS DISCIPLINARY TRAINING TO
ADVANCE RESEARCH.
DIFFERENT WAYS WE'RE DEVELOPING
THE WORKFORCE.
WE HAVE TIME SENSITIVE
OPPORTUNITIES FOR RESEARCH.
THIS CAME FROM THE COVID
EPIDEMIC AND NEEDED TO PIVOT
QUICKLY.
WE'RE THINKING OF PLANNING THREE
YEARS AHEAD WITH THE TIME
SENSITIVE OPPORTUNITY IF YOU
WANTED TO LOOK AT AND ADD
RESEARCH WE COULD DO THAT WITH A
SUPPLEMENT.
THEN WE HAVE SUPPORT FOR
MATERNAL HEALTH INITIATIVES TO
IMPROVE CAREER ENHANCEMENT AWARD
AND K18 ADVANCING THE STUDY OF
INTIMATE PARTNER VIOLENCE IN THE
CONTEXT OF MATERNITY, MORBIDITY
AND MORTALITY AND A SHORT COURSE
ON TECHNIQUES AND PLEASURING
INTIMATE PARTNER VIOLENCE, R25
AND TRAINING AWARD IN THESE
AREAS.
WE HAVE THE K18 WITH NOFOs
COMING OUT IN AWARDS ANTICIPATED
2024.
YOU CAN SEE WITH THE LEADS
WORKING WITH YOU ALL IN THESE.
PART OF THE WORK WE DO WE HAVE
OSDP FOR DISABILITIES WE HAVE
PROVIDED CO-SPONSORSHIP FOR THE
WORKSHOP ON ABLISM AND MEDICINE
CLINICAL RESEARCH AND
CO-SPONSORED THE RFA ON
UNDERSTANDING AND MITIGATING
HEALTH DISPARITIES EXPERIENCED
IN PEOPLE WITH DISABILITIES IN
THE OFFICE AND NIMHD AS AN
EX-OFFICIO MEMBER AND LOOKING AT
THE DISPARITIES AND AS PLUG FOR
UPCOMING EVENTS STARTING IN END
OF JUNE WE HAVE SCIENTIFIC
CONFERENCING HYBRID-VIRTUAL, IN
PERSON.
THE PROS AND CONS AND WHAT DOES
RESEARCH SAY ABOUT THAT AND TWO
DIRECTOR'S WEBINARS ONE BY REC
BECCA LONG ON AGE DISPARITIES
AND ONE ON JUSTICE INVOLVED
INDIVIDUALS AND CHECK OUT OUR
WEBSITE AND THE RESOURCES WE
HAVE FOR JUNIOR INVESTIGATORS
AND FIND OUT MORE ON WHAT WE'RE
DOING.
THANK YOU VERY MUCH.
>> THANK YOU.
WE HAVE ABOUT FIVE MINUTES FOR
QUESTION.
>> VERY USEFUL.
VERY INTERESTING.
A COUPLE QUESTIONS I'LL FOCUS ON
ONE REALLY.
YOU TALK ABOUT THE SOCIAL
DETERMINATES OF HEALTH AND
PREVIOUSLY WOE WERE TRACKING THE
DATA AVAILABLE IN SWEDEN.
ACTUALLY IN THE U.S. WE'RE
TRYING TO DEVELOP SIMILAR DATA
SETS THAT TRACK INDIVIDUALS FOR
LONG -- NOT THEIR ENTIRE LIFE
TIME BUT LONG STRETCHES OF THEIR
LIFE AND STRIKES ME IT'S LIKE AN
OBVIOUS AREA FOLKS IN YOUR
BRANCH MAY BE INTERESTED IN
INCORPORATING SOME OF THE SHORT
AND LONGER TERM SOCIAL OUTCOMES
ASSOCIATED WITH HEALTH.
I DON'T KNOW IF YOU COULD SPEAK
TO THAT AND THERE'S HEALTH SHOCK
AND SOCIAL IMPLICATION THAT
CREATES SOMETHING THAT FEEDS
INTO HEALTH AND A FUTURE.
>> WHAT ARE YOU THINKING?
WHAT ARE EXAMPLES OF THAT.
>> WE'RE SO FOCUSSED ON THE
HEALTH OUTCOMES AND MORBIDITY
AND MORTALITY AT AN INDIVIDUAL
LEVEL.
>> ANYTHING THAT AFFECTS HEALTH
PARTICULARLY EARLY IN LIFE IS
GOING TO HAVE ALL KINDS OF
SOCIAL AND ECONOMIC IMPACTS ON
EDUCATIONAL ATTAINMENT, ON LABOR
MARKET OUTCOMES AND THAT OF
COURSE WILL THEN FEED INTO
FUTURE HEALTH.
SO THIS -- WE TALKED ABOUT IT
BEFORE THINKING MORE ABOUT THE
FULL LIFE CYCLE OF AN INDIVIDUAL
AND HOW HEALTH CONDITION AND
SOCIAL CONDITIONS.
>> I'LL LOOK INTO THAT.
WE DO FOCUS MORE ON THE
INDIVIDUAL OUTCOMES AND AS WE
THINK ABOUT DETERMINATES AND
EARLY ON THERE'S A GREATER
IMPACT THE LONGER INVOLVED BUT
WE DON'T OFTEN FOLLOW THEM AND
LOOK AT THE BI-DIRECTIONAL
IMPACT.
THAT'S A GOOD POINT.
>> THERE ARE FOLKS IN THE CENSUS
BUREAU TRYING VERY HARD TO
CREATE THESE LONGITUDINAL DATA
SETS THAT FOLLOW INDIVIDUALS
OVER THEIR ENTIRE LIFE TIME AND
SEEMS THERE SHOULD BE MORE
COMMUNICATION.
>> WE HAVE LONGITUDINAL DATA AND
WE'RE TRYING TO BETTER
INCORPORATE THE SOCIAL
DETERMINATES AND LOOK AT
BI-DIRECTIONAL INFLUENCES WOULD
BE A GOOD AREA OF RESEARCH.
THANK YOU.
>> SUSAN.
>> THANK YOU.
I THINK MAYBE FOLLOWING UP ON
THIS I WONDER AND MAYBE THIS IS
SOMETHING YOU MAY NEED TO THINK
MORE ABOUT AS WELL BUT I
APPRECIATED YOU HIGHLIGHTING THE
IMPORTANCE OF THE MULTI-LEVEL
RESEARCH AND THE COMPLEXITY OF
IT AND I'M JUST WONDERING IF YOU
HAVE THOUGHTS ABOUT WHAT FUNDING
SOURCES COULD BE DOING MORE
EFFECTIVELY TO HELP SUPPORT THAT
KIND OF RESEARCH WHICH I THINK
HAS DIFFERENT DIMENSIONS TO IT
MAYBE THAN MAYBE SOME OF THE
MORE INDIVIDUALLY ORIENTED
TRADITIONAL --
>> IT'S EXPENSIVE TO DO.
I CAN'T CRITICIZE NIH AND TELL
YOU THE R01 LEVEL HAS BEEN TO UP
BUT IT'S DIFFICULT TO DO THE
RESEARCH THE FUNDING LEVELS WERE
NOT SET UP TO DO THAT AND HAVE
TO BE CREATIVE IN HOW TO GO
ABOUT DOING IT AND MAYBE
COMBINING DATA SET AND
PREFERABLY OTHER LEVELS OF
INFLUENCE AND THERE'S A
BUDGETARY CONSTRAINT AND THERE'S
A LACK OF IMAGINATION AND IT'S
MORE THE TEAM SCIENCE APPROACH
THAT NEEDS TO BE IMPLEMENTED
MORE THAN IT IS ACTUALLY THE
VOLUNTARY CONSTRAINTS BUT IT'S
DIFFICULT.
YOU LIKE THE IDEAS OF THE R25
AND HELP DEVELOP SKILLS IN
PEOPLE AND ALSO THINKING ABOUT
R25 IS NOT GOING TO CHANGE A
BIOMEDICAL RESEARCHER INTO A
BEHAVIORAL SCIENTIST AND WILL
GIVE THE LANGUAGE TO TALK TO
SOMEONE AND FINDING WAYS TO
COMMUNICATE THAT WOULD BE A GOOD
INVESTMENT OF YOUR OFFICE.
>> IT DEPENDS ON PEOPLE BEING
WELL TRAINED UP THEIR
DISCIPLINED.
AND THE LANGUAGE OF THE OTHERS
AND THE OPPORTUNITIES TOWARDS
OTHER AREAS THAT'S IMPORTANT.
>> THANK YOU SO MUCH.
CLEARLY WE FOUND THE RIGHT
LEADER IN YOU.
YOU'RE VERY CLEAR HOW TO CREATE
SYNERGY.
THAT'S A KEY WORD YOU
HIGHLIGHTED.
WE HAVE TO DO INTERVENTIONS
POWERFUL ENOUGH TO DEFECT
EFFECTS AROUND OUTCOMES OVER A
LONGITUDINAL PERIOD.
HAVE YOU BEEN LOOKING AT THE
OTHER ANALYTIC MODELS AND
APPROACHES AT OUR FINGERPRINTS
WHERE WE DIDN'T HAVE MODELS AND
OTHER WAYS TO USE MORE OF THE
DEEP LARGER LANGUAGE MODELS AN
CONNECT DATA SETS TO ANSWER ALL
THE IMPORTANT INTERACTIONS AND
DELAYED TEMPORAL EFFECTS.
>> GREAT SUGGEST.
I THINK I SKIPPED OVER SOME OF
OUR RESEARCH PRIORITIES.
THE SECOND IS INVESTIGATION
INNOVATION.
.
AND WE LOOK AT METHODOLOGICAL
DESIGNS AND ANALYSIS AND I'M
EXCITED ABOUT A.I. AND THE
POTENTIAL OF WHAT IT CAN DO FOR
US.
I THINK AND LOOKING AT THE
BEHAVIORAL AND SOCIAL SCIENCE
AND GETTING A BETTER GRIP
CONCEPTUALLY WHAT WE'RE LOOKING
AT THAT ARE DEFINITION OF KEY
TERMS AND I THINK THAT WILL BE A
HUGE GROWTH AREA TO LOOK AT
DIFFERENT KINDS OF ANALYTIC
TECHNIQUES AND DIFFERENT KINDS
OF DESIGNS METHODOLOGICAL
DESIGNS THAT'S WHERE THE R25
FOCUSES ON AND ANALYZING DATA TO
GET AT MULTI-LEVEL PATIENTS.
THANK YOU.
>> I THINK WE NEED TO MOVE ON.
THANK YOU, GREAT PRESENTATION.
YOUR WELCOME TO STAY FOR THE
SUBSEQUENT PRESENTATION I THINK
YOU'LL BE INTERESTED IN.
THE SCIENTIFIC THEME OF THE
COUNCIL MEETING IS LARGE DATA
ANALYSIS AND ARTIFICIAL
INTELLIGENCE IN NICHD RESEARCH.
WE'LL NOW HEAR A SCIENTIFIC
PRESENTATION FROM DOCTORSAGAGE
KATHY EDIN AND MABLG YOU
SALGANIK.
IT'S A NATIONAL REPRESENTATIVE
ONGOING LONGITUDINAL BOTH COHORT
SURVEY OF 4,998 DRAWN FROM LARGE
STUDIES.
THEY'LL DESCRIBE RECENT WORK
THAT HIGHLIGHTS THE USE OF
APPROACHES TO PREDICT SOCIAL AND
BEHAVIORAL OUTCOMES.
DR. KATHY EDIN IS THE WILLIAM
CHURCH OSBORNE PROFESSOR OF
SOCIOLOGY AND PUBLIC AFFAIRS AT
THE PRINCETON UNIVERSITY SCHOOL
AND INTERNATIONAL AFFAIRS AND
THE DIRECTOR OF THE CENTER FOR
RESEARCH ON CHILD WELL BEING.
SHE CONDUCTS RESEARCH ON
POVERTY.
SHE'S AN ELECTED MEMBER OFF THE
NATIONAL ACADEMIES OF SCIENCES,
AMERICAN ACADEMY OF POLITICAL
AND SOCIAL SCIENCES AND THE
NATIONAL ACADEMY OF SOCIAL
INSURANCE AND ARTS AND SCIENCES.
DR. SALGANIK IS A PROFESSOR AT
PRINCETON UNIVERSITY CONDUCTING
COMPUTATIONAL SOCIAL SCIENCE AND
RESEARCH AND RECEIVED NUMEROUS
AWARDS AND HIS WORK HAS BEEN
FUNDED BY THE NIH, MULTIPLE
FOUNDATIONS AND FACEBOOK AND
GOOGLE AND SERVED AS THE
PROFESSOR IN RESIDENCE IN NEW
YORK TIMES TO 2019.
WELCOME BOTH OF YOU AND HAND THE
ENVIRONMENT PODIUM OVER TO YOU.
THANK YOU.
>> MY BACKGROUND IS IN
COMPUTATIONAL AND SOCIAL
SCIENCES AND SOCIAL RESEARCH IN
THE DIGITAL AGE IS A BOOK I
WROTE AND FOR DATA SCIENCES WHO
WANT TO DO MORE SOCIAL SCIENCE
AND ANYONE INTERESTED IN THE
HYBRID OF THESE TWO FIELDS.
WHEN PEOPLE THINK ABOUT
COMPUTATIONAL SOCIAL SCIENCE
THEY OFTEN THINK OF NEW SOURCES
OF DATA.
THEY THINK ABOUT MOBILE PHONE
DATA OR ONLINE DIGITAL DATA AND
SO ON.
WHAT I WANT TO ARGUE IS THAT
COMPUTATIONAL SOCIAL SCIENCE
ALLOWS US TO ASK NEW QUESTIONS
WITH DATA THAT WE ALREADY HAVE
AND I'M GOING TO GIVE AN
ILSTRAIGHT ADMINISTRATION OF
THAT.
THE PROJECT FOCUSES ON THIS
QUESTION OF WHAT WE CALL LIFE
TRAJECTORY TASK AND GIVEN DATA
OF A PERSON'S ENVIRONMENT HOW
WELL CAN WE PREDICT THEIR
OUTCOMES.
THIS QUESTION IS OBVIOUS AND
HERETICAL WHEN I HANG OUT WITH
COMPUTER SCIENCE -- SCIENTISTS
THE THINK THIS IS THE FIRST
QUESTION TO ASK AND OTHERS DONT
CHOOSE TO ASK THIS QUESTION.
WHEN YOU TALK TO COLLEAGUES IN
SOCIAL SCIENCE THEY THINK THIS
IS NOT A QUESTION WE SHOULD BE
ASKING OR NOT A PARTICULARLY
INTERESTING QUESTION.
AND THIS WAS WRITTEN BY CICERO
AND HAS TOPIC ON STAYING POWER
AND IT'S EXCITING AND SCARY.
ON ONE HAND WE ALL KNOW ABOUT
THE POTENTIAL FOR ALGORITHMIC
SYSTEMS TO BE BIASSED AND KNOW
ABOUT DATA AND RESEARCH AND
HELPING PEOPLE MAKE BETTER
DECISIONS.
THINKING ABOUT THE PROBLEM
REQUIRES THINKING ABOUT ALL OF
THESE TENSIONS SIMULTANEOUSLY.
AND SO AN EXAMPLE MANY OF A
DECISION THIS IS A NEW YORK
TIMES MAGAZINE ARTICLE FROM
YEARS AGO ABOUT WHAT'S HAPPENING
IN ALEGHENNY COUNTY,
PENNSYLVANIA, PITTSBURGH, AND
WERE TRYING TO USE A MACHINE
LEARNING MODEL TRAINED ON THE
ADMINISTRATIVE DATA THE COUNTY
HAD TO HELP CREATE A RISK
PREDICTION SYSTEM FOR KIDS WHO
ARE AT RISK.
WE ALL KNOW THAT THESE KIND OF
SYSTEMS CAN BE BIASSED.
WE ALSO ALL KNOW THAT THE
CURRENT SYSTEMS THAT EXIST IN
MANY SOCIAL SERVICE AGENCIES DO
NOT LIVE UP TO OUR HIGHEST
IDEALS.
AND SO THE QUESTION IS, IS THERE
A WAY WE CAN DO THIS BETTER BY
TAKING ADVANTAGE OF DATA?
NOW, THAT IS A VERY HARD
QUESTION AND THERE'S A LOT OF
TENSION BETWEEN THOSE TWO THINGS
BUT ONE THING THAT WE'VE NOTICED
IS THAT THERE ARE EVEN DEEPER
SCIENTIFIC QUESTIONS THAT ARE
NOT ANSWERED BEFORE WE WOULD
EVEN BEGIN TO DEBATE SOME OF
THESE POLICY QUESTIONS.
FOR EXAMPLE, HOW PREDICTABLE ARE
LIFE TRAJECTORIES FROM THE DATA
AND IF THEY'RE ACCURATE IT LEADS
TO ONE SAID OF POLICY
CONSIDERATIONS.
IF THE ALGORITHMS ARE NOT VERY
ACCURATE IT LEADS TO A DIFFERENT
SET OF POLICY CONSIDERATIONS.
THERE'S BASIC SCIENCE THAT TO BE
DONE HERE TO HELP INFORM THESE
IMPORTANT DEBATES.
THIS BASIC SCIENCE ALSO HELPS US
ADVANCE OUR UNDERSTANDING OF
SOCIETY.
SO ONE WAY TO THINK ABOUT THE
CHANGE THAT'S HAPPENING HERE IS
IF YOU THINK ABOUT A REGRESSION
MODEL, SO REGRESSION MODEL WE
ALL KNOW HAS SOME MANY OUTCOMES
AND BETA HATS, THE WEIGHTS THAT
APPLY TO THE PREDICTORS.
SO IF YOU HANG OUT WITH SOCIAL
SCIENTISTS AND GO TO A TALK IN A
SOCIAL SCIENCE DEPARTMENT, IT
WILL VERY MUCH BE FOCUSED ON THE
BETA HATS.
SOMEONE WILL HAVE A THEORY AND
HAVE DATA AND RUN REGRESSION
MODEL AND THEN THEY'LL FOCUS ON
INTERPRETING THE BETA HATS.
HOWEVER, IF YOU HANG OUT WITH
DATA SCIENTISTS THEY FOCUS ON
HOW ACCURATELY CAN WE PREDICT
THE OUTCOMES.
IF WE HAVE AN ALGORITHM TO
PREDICT WHICH E-MAIL IS SNAM OR
NOT SPAM WE FOCUS ON HOW
ACCURATELY WE CAN MAKE THE
PREDICTION AND DON'T FOCUS ON
THE WEIGHTS IN OUR MODEL.
SO WE HEARD FOR A LONG TIME
ABOUT THIS TENSION BETWEEN
PREDICTION AND EXPLANATION OR
PREDICTION AND UNDERSTANDING AND
WHAT I WANT TO ARGUE IS I THINK
WE'RE GOING TO MOVE TO A SETTING
WHERE WE THINK OF PREDICTION AND
UNDERSTANDING AS THINGS THAT
MUTUALLY SUPPORT EACH OTHER.
IN MEASURE LEARNING IT'S A MOVE
TOWARDS INTERPRETABLE MACHINE
LEARNING.
THIS IS BROADLY SPEAKING
BRINGING IN A LOT OF THE
TECHNIQUES THAT SOCIAL
SCIENTISTS HAVE DEVELOPED FOR
INTERPRETING NON-LINEAR MODELS
AND INCREASINGLY WE'LL SEE
SOCIAL SCIENCES FOCUS ON
PREDICTION NOT AS A THING IN AND
OF ITSELF BUT AS A WAY TO BUILD
UNDERSTANDING AND IN THE WORK
THAT FOLLOWS I'LL TRY TO GIVE AN
EXAMPLE WHERE WE'LL SEE WHY IN
THE SERVICE OF BETA HAT OR
PREDICTION IN THE SERVICE OF
UNDERSTANDING.
THIS IS A PAPER THAT I WORKED ON
WITH MY REMEMBER 111 MANY
CLOSEST FRIENDS.
THE PREVIOUS SPEAKER MENTIONED
TEAM SCIENCE AND THIS IS A
BEAUTIFUL EXAMPLE OF WHAT WE CAN
ALL DO TOGETHER THAT NONE OF US
CAN DO INDIVIDUALLY.
THAT'S THE KIND OF SCIENCE WE'RE
EXCITED ABOUT.
WE STARTED WITH THIS AMAZING
DATA SET THAT HAD BEEN COLLECTED
BY MY COLLEAGUES AND SEVERAL
OTHER P.I.s.
SINCE AROUND THE YEAR 2000 THIS
STUDY WAS FORMALLY CALLED THE
FUTURE OF FAMILIES AND CHILD
WELL BEING STUDY AND WE'RE
FOLLOWING NOT JUST THE ORIGINAL
CHILDREN BUT THE CHILDREN OF THE
ORIGINAL CHILDREN AS THE STUDY
HAS MOVED TO A
MULTI-GENERATIONAL STUDY.
KATHY AND GENE ARE CURRENTLY THE
P.I.s OF THIS AMAZING PROJECT.
SO WHAT IS THIS LONGITUDINAL
DATA SET?
THEY SAMPLED THOUSANDS OF
CHILDREN BORN IN 20 U.S. CITIES
WITH AN OVERSAMPLE OF
NON-MARITAL BIRTHS.
ONE ORIGINAL GOAL WAS TO
UNDERSTAND OUTCOMES FOR CHILDREN
WHO ARE MARRIED AND HOW THEY
DIFFERENT FROM THOSE WHO ARE NOT
MARRIED AND THE FAMILIES WERE
FOLLOWED SINCE BIRTH AND DATA
HAS BEEN USED IN MORE THAN 1,000
PUBLISHED PAPER.
IT'S AN INCREDIBLY WIDELY USED
AND VALUABLE DATA SOURCE.
SO WHEN I GOT INVOLVED THIS IS
THE WAY THE DATA SET WAS
STRUCTURED.
SO, DATA COLLECTED WHEN KIDS
WERE BORN AND 1, 3, 5 AND 9 AND
AS THE KID GETS OLDER MORE AND
MORE INFORMATION IS BEING
COLLECTED AROUND THE KID AND
ABOUT THE ENVIRONMENT AROUND THE
KID.
WE TALKED ABOUT THE SOCIAL
DETERMINATES AROUND UNDER THE
CIRCLES IS THE INFORMATION AND
ONE SAYS CORE MOTHER SURVEY,
BIRTH.
THIS HAS ABOUT 10 MODULES.
EACH MODULE HAS ABOUT 10
QUESTI
QUESTIONS AND LOOK AT FATHERHOOD
AND MARRIAGE ATTITUDES AND SO ON
AND CONTRAST THIS TO THE BIG
DATA THAT WE OFTEN WORK WITH AS
RESEARCHERS.
HERE WE ARE WORKING NOT WITH THE
DIGITAL EXHAUST THAT THESE
PEOPLE ARE LEAVING BEHIND ON X,
TWITTER OR FACEBOOK.
WE'RE WORKING WITH QUESTIONS
THAT ASKED BY RESEARCHERS FOR
THE PURPOSE OF RESEARCH.
THESE QUESTIONS ARE DRIVEN BY
IMPORTANT THEORIES IN THE FIELD
AND THAT MAKES THIS KIND OF
RESEARCHER COLLECTED DATA
INCREDIBLY VALUABLE.
SO THIS IS WHAT WAS COLLECTED
FROM THE MOTHER AT BIRTH AND
THEN THIS IS THE FULL SET OF
QUESTIONS COLLECTED BETWEEN
BIRTH AND YEAR 9.
IT'S AN INCREDIBLY RICH DATA
SET.
OKAY.
BY THE TIME I GOT INVOLVED THE
DATA FROM BIRTH TO YEAR 9 WAS
AVAILABLE TO RESEARCHERS AND HAD
BEEN WIDELY USED IN MANY
IMPORTANT RESEARCH PAPERS.
THE DATA FROM WHEN THE KIDS WERE
15 YEARS OLD HAD BEEN COLLECTED
BUT WAS NOT YET WIDELY
AVAILABLE.
SO THE FUTURE OF FAMILIES TEAM
WAS CLEANING THE DATA,
DOCUMENTING IT AND PREPARING IT
TO BE RELEASED.
THIS IS AN AMAZING, AMAZING
RESEARCH OPPORTUNITY.
IT'S A VERY SPECIAL MOMENT WHEN
YOU HAVE SOME DATA THAT HAS BEEN
COLLECTED BUT NOT YET WIDELY
AVAILABLE.
I WANT TO EMPHASIZE THIS MOMENT
EXISTS EVERY LONGITUDINAL STUDY
THAT HAS EVER BEEN DONE AND
EXISTS INSIDE EVERY LONGITUDINAL
STUDY THAT HAS BEEN DONE AND AN
OPPORTUNITY PEOPLE HADN'T TAKEN
ADVANTAGE OF YET.
IF YOU SHOWED A PICTURE LIKE
THIS TO A DATA SCIENTIST, THE
FIRST THING THEY WOULD THINK IS
OR ONE OF THE FIRST THING THEY
WOULD THINK IS USING THE COMMON
TASK METHOD.
LET ME EXPLAIN WHAT THAT IS.
THIS IS A WAY A DATA SCIENTIST
MAY LOOK AT THE FUTURE OF
FAMILIES DATA.
THERE'S DATA ON THE PROJECT ON
ABOUT 4,000 FAMILIES AND WHEN WE
CONNECT UP ALL THE DATA THAT HAS
BEEN COLLECTED ABOUT THE
FAMILIES FROM THE TIME THE KID
WAS BORN TO THE TIME THE KID WAS
9 YEARS OLD COMES UP TO 13,000
VARIABLES.
IT'S AN ENORMOUS AMOUNT OF
INFORMATION.
A VERY SMALL NUMBER OF THE
VARIABLES ARE ROUTINELY USED IN
RESEARCH.
I WAS SHOCKED TO SEE HOW MANY
THINGS HAD BEEN COLLECTED.
YOU'LL NOTICE THE DATA IS WIDER
THAN IT IS TALL.
THIS IS SOMETHING WE DON'T OFTEN
WORK WITH IN THE SOCIAL
SCIENCES.
COMES UP MORE IN GENETIC
RESEARCH, FOR EXAMPLE.
COMES UP OFTEN IN MACHINE
LEARNING AND THERE'S A NUMBER OF
TECHNIQUES THAT ARE DESIGN TO
WORK WITH THE DATA THAT IS WIDE
AND SHORT THAT WE THOUGHT WERE
VERY EXCITING TO USE ON THIS
AMAZING DATA SET.
SO WHAT WE DID IS THEN PICKED
SIX OUTCOMES THAT WE WANTED
PEOPLE TO PREDICT.
ONE OF THOSE IS THE GRADES OF
THE KIDS IN SCHOOL WHEN THEY'RE
15.
THEN RESEARCHERS COULD APPLY TO
GET THIS BACKGROUND DATA AND THE
OUTCOME DATA AND THEN COULD
BUILD A MODEL USING ANY
TECHNIQUE THEY WANT.
THEY COULD USE ANY MACHINE
LEARNING TECHNIQUE, THEY COULD
USE ANY SOCIAL SCIENCE THEORY,
THEY ARE COULD USE ANY
COMBINATION MUCH ANY OF THESE
THINGS AND THE GOAL WAS TO
PREDICT THE OUTCOMES FOR THE
KIDS WHOSE OUTCOMES THEY HAD NOT
SEEN.
SO HERE YOU'LL SEE THE TWO
BOXES.
THE LEADER BOARD AND HOLDOUT AND
THE QUESTION IS HOW WELL CAN
PEOPLE PREDICT THE UNSEEN DATA?
IT WAS AVAILABLE DURING THE
CHALLENGE TO QUERY.
WE'RE NOW GOING TO FOCUS ON THE
HOLDOUT DATA.
THIS IS DATA KEPT HIDDEN UNTIL
THE END AND COMPARE IT TO THE
HELD OUT DATA AN ONE THING ABOUT
THE RESEARCH DESIGN, THIS IS A
REALLY POWERFUL DESIGN THAT HAS
BEEN DEVELOPED BY COMPUTER
SCIENTISTS.
JUST LIKE A RANDOMIZED CONTROL
TRIAL IS A GOOD DESIGN FOR
MEASURING CAUSAL EFFECTS, THE
COMMON TASK METHOD IS A GOOD
DESIGN FOR PRODUCING CREDIBLE
ESTIMATES ABOUT PREDICTABILITY.
IF WE HAVE HUNDREDS OF
RESEARCHERS FROM AROUND THE
WORLD ATTEMPTING TO DO THIS TASK
AND SOMEONE ENDS UP DOING WELL
THAT CANNOT BE EXPLAINED AWAY
BASED ON RESEARCHER DEGREES OF
FREEDOM OR P HACKING OR OTHER
KINDS OF THINGS LIKE THAT.
CHANGING THE METRIC.
ALL THESE THINGS ARE PRE
SPECIFIED BY US TO BE CONFIDENT
RESEARCHERS ARE ABLE TO DO THIS
TASK.
ALTERNATIVELY, IF NO ONE IS ABLE
TO DO THIS TASK WELL THAT'S A
SIGN AS THE TRULY DIFFICULT.
WE CANNOT ATTRIBUTE THE
INABILITY TO ACHIEVE THE TASK TO
THE FAILURE OF ANY ONE
PARTICULAR RESEARCH GROUP.
FOR EXAMPLE, IF I TRIED TO
PREDICT THE GRADES OF THE KIDS
AT AGE 15 AND WASN'T VERY
SUCCESSFUL YOU MIGHT SAY THAT'S
BECAUSE MATT DOESN'T KNOW ABOUT
RANDOM FOREST OR ABOUT THE
NEWEST TRANSFORMER MODELS OR
DOESN'T KNOW ENOUGH ABOUT
EDUCATION FOR A MILLION REASONS
AND IF HUNDREDS OF RESEARCHERS
TRY AND NO ONE IS ABLE TO DO IT,
IT'S A STRONG INDICATION IT'S A
HARD TASK.
AND SO THIS IS WHAT WE DID.
WE HAD HUNDREDS OF RESEARCHERS
AROUND THE WORLD PARTICIPATE IN
THE SOCIAL SCIENTISTS,
UNDERGRADUATES, GARAGE AT
STUDENTS, FACULTY, SCIENTISTS IN
INDUSTRY.
HERE'S THE MAIN QUESTION USING A
DATA SET COLLECTED SINCE BIRTH
AND MODERN MACHINE LEARNING
METHODS ONLY FOCUSSED ON
OPTIMIZING PREDICTIVE ACCURACY
AND THE RESULTS ON THE METRIC OF
R SQUARED IN THE HOLDOUT SET AND
I WANT TO SHOW THE METRIC
BECAUSE OFTEN WHEN WE ASSESS
RESULTS FROM PREDICTIVE MODELS
RESEARCHERS ARE NOT OFTEN VERY
CLEAR ABOUT WHAT THE METRIC IS
MAKES IT HARD FOR THEM TO BE
INTERPRETED.
SO HERE THE METRIC GOES FROM
ZERO WHICH IS THIS MODEL IS NO
MORE ACCURATE THAN PREDICTING
THE MEAN OF THE TRAINING DATA TO
ONE WHICH IS THIS MODEL IS
PERFECTLY ACCURATE.
WE HAVE HUNDREDS OF PEOPLE
PARTICIPATE IN THIS TASK.
WE HAD SIX OUTCOMES.
SOME PROPERTY OF THE CHILD AND
SOME OF THE HOUSEHOLD AND SOME
PROPERTY OF THE PRIMARY
CAREGIVER USUALLY THE MOTHER.
WITH -- WE LOOKED TO SEE THE
OUTCOMES OF THE BEST MODELS.
THE R SQUARED VALUES FROM GPA
AROUND .2 AND THE OUTCOMES FOR
THE OTHER VALUES ARE CLOSE TO
ZERO.
I WANT TO EMPHASIZE THIS IS THE
BEST OF 160 TEAM SUBMISSIONS.
THIS IS NOT THE AVERAGE.
THIS IS THE BEST.
SO THIS IS ONE WAY YOU CAN LOOK
AT THE RESULTS.
HERE'S ANOTHER WAY YOU CAN LOOK
AT THE RESULTS WHICH I THINK IS
THE BETTER WAY.
THIS EMPHASIZES IT CAN GO FROM
ZERO TO 1 AND HIGHLIGHTS
EVERYTHING THE AMAZING RESEARCH
TEAM IN THE FUTURE OF FAMILIES
HAS THOUGHT ABOUT PLUS STATE OF
THE ART MACHINE LEARNING GIVES
YOU WHAT IS IN BLUE BUT THE
DOMINANT PATTERN HERE IS WHAT IS
NOT IN BLUE THE VAST WHITE
SPACE.
THERE'S AN ENORMOUS AMOUNT
HAPPENING IN THE LIVES OF THESE
KIDS AND THE FAMILIES WE DO NOT
YET UNDERSTAND.
WHEN YOU SEE A RESULT FROM A
PREDICTIVE MODEL YOU NEED TO ASK
IF IT'S BETTER THAN A BENCHMARK
MODEL.
I MAY SAY I HAVE A SYSTEM FOR
PREDICTING THE WEATHER IN LOS
ANGELES AND PREDICT IT WILL BE
SUNNY AND YOU'D SAY THAT'S NOT
THAT IMPRESSIVE BECAUSE IT'S
PRETTY MUCH ALWAYS SUNNY IN LOS
ANGELES.
WE WANT TO COMPARE THE OUTCOME
OF THE LEARNING PREDICTIONS TO A
SIMPLER MODEL.
WE WORKED WITH A DOMAIN EXPERT
AND ASKED THEM WHAT WOULD BE
FOUR IMPORTANT VARIABLES AN PUT
IT INTO A REGRESSION MODEL AND
THIS IS WHAT WE GOT.
IF YOUR INTUITION IS IT WILL
MAKE A SMALL IMPROVEMENT THAT'S
CONSISTENT WITH WHAT WE FOUND.
MANY OF US DON'T THINK OF THE R
SQUARED RESULTS AND QUICKLY WHAT
THIS LOOKS LIKE.
IT'S A SQUATTER PLOT FOR ONE OF
THE OUTCOMES.
THIS IS THE GRADES OF THE KID IN
SCHOOL THE X AXIS IS THE TRUTH
AND Y IS THE PREDICTION AND IF
EVERYTHING WAS WORKING PERFECTLY
IT WOULD FALL ALONG THE 45
INTERESTING LINE.
A BETTER INTUITION IS THE MEAN
OF THE TRAINING DATA.
THE GPA IS 2.87.
FOR THE BEST MODEL IT'S
BASICALLY PREDICTING THE MEAN OF
THE TRAINING DATA WITH A LITTLE
BIT OF SIGNAL NOTE THE TRUTH
WITH NOISE AND HERE'S THE BEST
SUBMISSION ON THE RIGHT SIDE.
ON THE LEFT SIDE IS THE
BENCHMARK FOR THE MODEL AND THIS
IS WHAT WE SEE ACROSS THE SIX
OUTCOMES.
TWO COMMON PATTERNS THE BEST
PREDICT IS CLOSE TO THE MEAN OF
THE TRAINING DATA AND THE BEST
SUBMISSION HAS 13,000 VARIABLES
IN STATE OF THE ART AND A LINEAR
REGRESSION MODEL.
WHAT IS GOING ON?
WE SPECULATED THERE'S STUFF
CALLED DARK MATTER.
IN ASTRONOMY DARK MATTER IS
STUFF WE KNOW IS OUT THERE BUT
DON'T QUITE KNOW WHAT IT IS.
WE WANTED TO GO AND FIND THE
DARK MATTER IN THE LIVES OF
THESE FAMILIES.
WE WANTED TO FIND WHAT IS IT
THAT'S ALLOWING SOME OF THE KIDS
TO DO BETTER THAN EXPECTED.
GIVEN THE BEST AVAILABLE
MODELLING AND DATA WE HAVE.
WHAT'S CAUSING SOME OF THESE
KIDS TO STRUGGLE UNEXPECTEDLY.
SO THAT LED US TO NOT USING
ANOTHER MACHINE LEARNING
TECHNIQUE.
WE DON'T KNOW ONE GOOD FOR
FINDING IMPORTANT AND UNMEASURED
VARIABLES BUT AS SOCIOLOGISTS WE
HAVE A TOOL CALLED GOING OUT AND
TALKING TO PEOPLE.
WE DID IN DEPTH QUALITATIVE
INTERVIEWS WITH THE PARTICIPANTS
IN THE FUTURE OF FAMILIES STUDY.
SO WE USED THIS PREDICTION
CRITICALLY TO HELP US DO THE
SAMPLING.
WHEN WE DO SAMPLING FOR
QUALITATIVE STUDY IT MAY BE AD
HOC SAMPLING OR RANDOM SAMPLING.
WE WERE SEARCHING FOR THE DARK
MATTER AND SAMPLED KIDS WITH
POSITIVE RESIDUALS AND LIKELY
HAVE THE GOOD DARK MATTER AND
KIDS WHO HAD BIG NEGATIVE
RESIDUALS MOSTLY HAVE THE BAD
DARK MATTER AND PICKED KIDS
DOING AS EXPECTED.
SO THEN IN COLLABORATION WITH
KATHY AND OTHER MEMBERS OF OUR
TEAM WE CAME UP WITH THIS
INTERVIEW DESIGN WHICH IS
ACTUALLY TITLE LY -- TIGHTLY
INTEGRATED WITH THE RESEARCH AND
LOVE THE WAY THE METHODS CAN
COMPLEMENT EACH OTHER AND
INTERVIEWED SEPARATELY AND
TALKED TO ABOUT 40 FAMILIES
SPREAD OVER CITIES AND NOTICE
STRUCTURED FACTORS THAT MAY BE
HARDER FOR THE FAMILIES
THEMSELVES TO SEE IF THEY ONLY
STAY IN ONE CITY.
WE DID LIFE HISTORY INTERVIEWS
AND EXPLICITLY FOCUSSED ON THREE
TIME PERIODS.
THE BIRTH TO YEAR 9 BECAUSE
THAT'S THE TIME PERIOD THAT THE
FUTURE FAMILIES DATA COLLECTION
WAS HAPPENING, THE 9 TO 15 AND
THAT THERE WAS A GAP WITH NO
DATA COLLECTION AND 15 PLUS TIME
PERIOD AFTER THE RESULTS YOU SAW
IN THE FRAGILE FAMILIES
CHALLENGE.
THAT IS NOT RELEVANT TO
EXPLAINING THE FRAGILE FAMILIES
CHALLENGE AND USEFUL FOR
UNDERSTANDING THE LIVES OF THESE
FAMILIES.
OF ONE INTERESTING THING ABOUT
THE INTERVIEW IS WE KNOW A LOT
ABOUT THE FAMILIES BEFORE WE
TALK TO THEM.
IN FACT WE HAD BEEN TALKING TO
THEM SINCE THEIR KID WAS BORN
AND IN DEPTH INTERVIEWS WE
TALKED ABOUT HOW MUCH
INFORMATION WE WANTED
INTERVIEWERS TO HAVE OR NOT HAVE
AND THE LEAD INTERVIEWER WAS
BLIND TO THE INFORMATION ABOUT
THE OUTCOMES.
SO THEY WERE BLIND TO WHETHER
THE OUTCOME OF THIS KID AT AGE
15 AND HOW IT COMPARED TO THE
PREDICTION AND THEN WE HAD A
SECOND INTERVIEWER UNBLINDED WHO
THOUGHT THE KID WAS DOING BETTER
OR WORSE THAN EXPECTED AND THE
SECOND INTERVIEWER WAS ABLE TO
UNDERSTAND MORE AND THE BLIND
INTERVIEWER DOING THE WHOLE AND
THE SECOND INTERVIEWER ASKING
FOLLOWING UP QUESTION AND THINK
THIS DESIGN GETS THE BEST FROM A
BLIND AND UNBLIND DESIGN.
THEN WE READ AND DISCUSSED THE
INTERVIEW TRANSCRIPTS OVER AND
OVER AND OVER.
AND WE SETTLED INTO THIS
FRAMEWORK.
I WANT TO SHOW THE FRAMEWORK AND
GIVE YOU ONE EXAMPLE FROM THE
INTERVIEW AND THEN WE'LL WRAP
UP.
SO IF YOU THINK ABOUT THE ORIGIN
OF PREDICTION ERROR, WHAT WE
KNOW ACTUALLY IS THAT PREDICTION
ERROR CAN BE DECOMPOSED TO THE
TWO COMPONENTS THAT ARE MUTUALLY
EXCLUSIVE AND EXHAUSTIVE.
THIS IS WHAT CANNOT BE RESOLVED
EVER BY PREDICTIVE ALGORITHM OR
MORE DATA SETS.
THIS IS WITHIN EACH GROUP,
SUBGROUP OF PEOPLE THERE'S
VARIABILITY IN THE OUTCOME AND
TO THE ALGORITHM WE COULD NEVER
DO BETTER THAN JUST PREDICTING
THE MEAN OF THE SUB GROUP.
SECOND, WE HAVE LEARNING ERROR
WHICH IS THE ABILITY OF THE
MACHINE LEARNING MODEL TO
CORRECTLY RECOVER THE MANY
SUBGROUP MEAN OF THIS GROUP.
SO ROUGHLY ONE COMPONENT IS LIKE
HOW MUCH WITHIN GROUP VARIATION
THERE IS AND THE SECOND
COMPONENT IS HOW WELL THE
MACHINE LEARNING MODEL CAN
KRAEKT -- CORRECTLY RECOVER THE
SUBGROUP MEAN.
WE TALKED ABOUT THE DIFFERENT
SOCIAL AND MEASUREMENT PROCESSES
THAT LED TO LEARNING ERROR.
WE TALKED ABOUT THREE DIFFERENT.
THINGS THAT CAN LEAD TO THIS
ERROR.
THIS IS ERROR THAT CANNOT BE
RESOLVED BY ANY MACHINE LEARNING
OR ANY AMOUNT OF DATA.
ONE EXAMPLE THIS IS FROM BELLA.
SO BELLA WAS A PARTICIPANT IN
OUR STUDY AND BELLA'S FATHER
UNFORTUNATELY PASSED AWAY AND
HER MOTHER BECAME DEPRESSED AND
HERE'S WHAT BELLA TOLD US.
WHEN HE PASSED AWAY, SHE CHECKED
OUT AND WAS DEPRESSED AND MY
MOTHER AND I WERE IN OUR OWN
WORLD AND THE PREDICTED GPA
BASED ON THE DATA WE HAVE
COLLECTED FROM BIRTH TO 9 WAS 3.
06 BUT NONE OF THAT INCLUDED THE
FACT THAT BELLA'S FATHER HAD
PASSED AWAY AND HER MOTHER HAD
BECOME DEPRESSED BECAUSE THAT
HAPPENED AFTER OUR DATA
COLLECTION HAD TAKEN PLACE AND
SO BELLA'S ACTUALLY GPA WAS 1.5.
HERE'S AN EXAMPLE OF SOMETHING
THAT HAPPENED OUTSIDE OUR DATA
COLLECTION WINDOW AND COULD NOT
HAVE MEASURED AND THOSE KINDS OF
UNMEASURABLE THINGS CAN LEAD TO
IRREDUCIBLE ERROR AND AND
THERE'S A NEW PAPER COMING OUT
THIS WEEK IN THE NEXT STUDIES
AND TALK ABOUT OUR NEXT STEPS.
SO WE FOUND THAT THE BEST
PREDICTIVE MODELS TRAINED ON A
HUGE DATA SET WERE NOT VERY
ACCURATE.
WE DID IN DEPTH INTERVIEWS TO
BUILD A CONCEPTUAL FRAMEWORK AND
PROCESSES THAT LEAD TO THE
ERRORS.
WE WANT TO AND WHEN I WAS
TRAINED AS A SOCIOLOGIST MOST
THE DATA WE HAD WAS SHORT AND
THIN AND RELATIVELY FEW NUMBER
OF FEATURES OR VARIABLES AND IT
COMES FROM THE NUMBER OF CASES
AND FEATURES AND INCREASINGLY WE
HAVE THIS SHORT AND WIDE DATA
LIKE THE FUTURE OF FAMILIES DATA
WHERE WE HAVE A HUGE NUMBER OF
VARIABLES AND HAVE A LIMITED
NUMBER OF CASES AND HERE WE
THINK THE LIMIT OF PREDICTION
WILL COME FROM THE NUMBER OF
CASES OR THE LACK OF THEORY THAT
HELPS US FIND AN APPROPRIATE
LOW-DIMENSIONAL REPRESENTATION
OF THE FEATURES.
AND ANOTHER ALTERNATIVE IS WE
HAVE ADMINISTRATIVE DATA WHICH
IS OFTEN TALL WITH MANY CASES
BUT THIN WITH VERY FEW FEATURES
AND THEY'RE NOT THE FEATURES
SOCIAL SCIENTISTS CARE ABOUT AND
MANY OPEN QUESTIONS ABOUT TALL
AND WIDE DATA.
SO WHAT HAPPENS WHEN YOU HAVE
TALL AND WIDE DATA, WHERE MIGHT
THE LIMIT OF SEPARATION COME
FROM THAT'S SOMETHING WE'RE
EXCITED ABOUT EXPLORING THIS
SUMMER IN THE DUTCH POPULATION
REGISTRY MAINTAINED BY STATISTIC
NETHERLANDS AND PEOPLE LIVING IN
THE NETHERLANDS AND A GREAT
PLACE TO USE A.I. MODELS
GENERALLY.
AND COMPUTATIONAL SOCIAL SCIENCE
AND THE INTERSECTION BETWEEN
SOCIAL AND DATA SCIENCE WAS
VERSION ONE AND I THINK WE'RE
GOING TO MOVE TO VERSION 2 WHICH
IS A MIX BETWEEN SOCIAL SCIENCE
AND A.I.
I THINK THIS WILL HAVE DIFFERENT
CHARACTERISTICS THAN THIS FIRST
GENERATION OF COMPUTATIONAL
SOCIAL SCIENCE AND I'M EXCITED
ABOUT THE NEW ERA AND AT THE END
I'D LIKE TO URN IT IT OVER TO
KATHY TO TALK MORE ABOUT THE
FUTURE OF THE FUTURE OF FAMILY
AND WELL BEING STUDY.
>> FANTASTIC.
I'LL SAY A COUPLE THINGS.
FIRST OF ALL THIS STUDY IS ONE
OF MANY STUDIES IN THE FUTURE OF
FAMILIES THAT IS A SATELLITE
STUDY.
THE SATELLITE STUDIES HAVE
ALLOWED US TO BE VERY
ENTREPRENEURIAL AS A STUDY AND
TO EVOLVE IN WAYS THAT WERE
NEVER PREDICTED BY THE FOUNDERS
OF THIS STUDY RUN AND ALL ARE
BUILT ON THE BED ROM OF A HIGH
RESPONSE RATE LONGITUDINAL
POPULATION BASED BIRTH COHORT
STUDY AND GIVES STRENGTH TO THE
SATELLITE STUDIES.
SECOND, AS YOU CAN SEE FROM THE
EXAMPLE WE'RE VERY ITERATIVE IN
OUR APPROACH.
YOU MAY KNOW I'M A QUALITATIVE
IN ETHNO GRAPHIC SCIENTIST AND
WE'RE BLENDING THESE METHODS AND
FROM EACH OF THE SATELLITE
STUDIES WE'RE BRINGING
INFORMATION TO THE CORE
FUNDAMENTALLY TRANSFORMING THE
CORE IN THE WAY THAT IS TRULY
INNOVATIVE.
THIRD WE'RE FOLDING IT AT EVERY
LEVEL YOUNG PEOPLE, YOUNG
RESEARCHERS.
MANY OF OUR SATELLITE STUDIES
ARE LED BY YOUNG RESEARCHERS,
LAURYN HILL, MATT, YOU'RE QUITE
A BIT YOUNGER THAN ME.
AND ALL OF THESE YOUNGER
SCHOLARS ARE BUILDING THEIR
CAREER ON THIS BED ROCK OF
HIGHLY RELIABLE DATA.
AND WE SUPPORT THESE YOUNG
RESEARCHERS AS THEY LEAD THESE
SATELLITE STUDIES AND GARNER
THEIR OWN RESEARCH FUNDING.
WE RUN THE SUMMER DATA WORKSHOP
EVERY YEAR FOCUSSED ON YOUNG
SCHOLARS OF COLOR AND WE SUPPORT
EVOLVING TRAINING THROUGH
WORKSHOPS WHERE PEOPLE CAN
PRESENT THEIR RESEARCH AND GET
EXPERT ADVICE.
ALL OF THESE EXPERTS ARE
ESPECIALLY FOCUSSED ON YOUNG
SCHOLARS OF COLOR.
I WILL STOP THERE.
WE'RE REALLY EXCITED TO PRESENT
THE STUDY TO YOU AND WISH YOU
LUCK IN YOUR DELIBERATIONS AND
YOU MEET IN WASHINGTON THIS WEEK
OR WHEREVER YOU ARE.
>> THANK YOU.
WE'RE IN ROCKVILLE, MARYLAND.
THANK YOU VERY MUCH DOCTORS EDIN
AND SALGANIK AND YOU TWO MAY NOT
BE PART OF AN IMPORTANT PART OF
OUR COUNCIL MEETING A SEGMENT
CALLED THE VOICE OF THE
PARTICIPANT.
THIS GIVES US A CHANCE TO HEAR
FROM THOSE WHO HAD PERSONAL
EXPERIENCES RELATED TO THE
RESEARCH THAT NICHD FUNDS.
TODAY WE ARE DELIGHTED TO
WELCOME MARY LOU AND ASSUMING
THE PERSON IN THE UPPER RIGHT IS
MARY LOU.
SHE HAS BEEN A PARTICIPANT IN
THE STUDY.
CAN YOU TELL US ABOUT YOUR
PERSONAL EXPERIENCES.
>> HI, GOOD AFTERNOON.
MY NAME IS MARY LOU I'M THE
MOTHER OF FIVE CHILDREN.
WE LIVE IN THE CITY OF
PHILADELPHIA.
BEFORE I BEGIN SHARING MY OWN
THOUGHTS ON THIS IMPORTANT
TOPIC, I'LL TAKE A MINUTE TO
THANK DR. EDIN FOR ASKING ME TO
PRESENT AND THANK YOU.
I'M VERY HONORED TO HAVE THIS
OPPORTUNITY TO BE THE VOICE OF
THE PARTICIPANT IN THIS MEETING
TODAY WITH ALL OF YOU HERE.
I ONLY HOPE I CAN DO JUSTICE TO
THE 25 YEARS OF RESEARCH THAT
WENT AMAZINGLY FAST FOR ME.
THE SURVEY BEGAN IN MID 1999.
I JUST DELIVERED TRIPLETS AFTER
3.4 WEEKS OF A HIGH-RISK REG
NANCY.
AFTER 18 WEEKS OF CARRYING WHAT
WE THOUGHT WAS OUR SECOND CHILD
WE DISCOVERED AFTER BLOOD WORK
WE WERE ACTUALLY HAVING NUMBER
TWO, THREE AND FOUR.
IT WAS QUITE A SHOCK TO LEARN WE
HAD HIT SUCH AMAZING ODDS WITH A
SPONTANEOUS TRIPLET BIRTH.
I WISHED WE WOULD HIT THE HOTRY
AND BUT THAT WOULD BE LIKE
LIGHTNING STRIKING TWICE AND OUR
OLDEST WAS IN RECALL HIGH SCHOOL
AND I COULDN'T PREPARE FOR THE
BIRTH CHILD AND WAS ON BED REST
LET ALONE THREE.
IT WAS HARD BUT I WAS DETERMINED
TO GO AS FAR AS I COULD FOR
THEIR GROWTH AND DEVELOPMENT.
I WAS IN AND OUT OF THE HOSPITAL
MANY TIMES.
I ALSO COULDN'T STOP THINKING
ABOUT THE LOSS OF MY INCOME AND
THE LOSS OF TIME AT HOME WITH MY
FAMILY TO PREPARE.
THE CHARGES THOSE DAYS IN THE
HOSPITAL WERE ADDING UP BUT I
NEEDED TO PHONE HOME AND CHECK
IN AND KEEP OUR FAMILY AND
FRIENDS UP DATED AND PASS TIME
WATCHING TV.
I WAS WORRIED AND OUR FAMILY
DEMOGRAPHIC WAS CHANGED IN THREE
MINUTES.
NOT LONG AFTER DELIVERY A WOMAN
CAME INTO MY ROOM AND ASKED IF I
WANTED TO PARTICIPATE IN A
SURVEY.
THERE WAS A SMALL STIPEND SHE
EXPLAINED SO I THOUGHT GREAT
I'LL PAY FOR THE TV.
SHE SAID WE COULD USE THE FIRST
BORN, AKA, BABY A NAMED LUKE.
I DIDN'T FULLY THEN REALIZE THE
SCOPE OF THE STUDY OR HOW IT
WOULD BECOME A SHARED EXPERIENCE
FOR JUST LUKE AND I OVER THE
PART OF 25 YEARS.
AT FIRST MY HUSBAND AND I WERE
ASKED QUESTIONS AND OUR
FINANCIAL CIRCUMSTANCES AND
PERHAPS OUR EDUCATIONAL
BACKGROUNDS AND BELIEFS.
NAMELY DISCUSSED THE MANY
REARING OF LUKE AND HOW HOME
TASKS WOULD BE DIVIDED AND WE
HAD OUR FIFTH CHILD IN 2001.
SOON THE SURVEY BECAME THE
SURVEY OF PARENTS AS LUKE BECAME
MORE VERBAL AND GREW HE BECAME
MORE OF THE FOCUS IN VISITS.
WE'D BE WEIGHED AND MEASURED AND
ASKED A SERIES MUCH QUESTIONS.
SOMETIMES HE'D BE GIVEN PICTURES
AND ASKED TO DESCRIBE THEM.
I ALWAYS FELT THEY WERE EARLY
CHILDHOOD I.Q. TESTS.
THOUGH MY HUSBAND WAS SURVEYED
EARLY ON, IT SEEMS TO HAVE
BECOME MORE FOCUSSED ON LUKE AND
ME AT SOME POINT.
STAYING IN THIS WAS IMPORTANT AS
IT ENABLE D ME TO HAVE THE ONE
THING I GOT TO DO AND LET ME SEE
HIS GROWTH AND DEVELOPMENT
SEPARATE FROM THE OTHERS.
THIS WAS IMPORTANT BECAUSE
THOUGH HE WAS THE LARGEST BY
WEIGHT AT BIRTH, HE HAD THE MOST
COMPLICATIONS AND WAS IN NICU
THE LONGEST AND DEVELOPED A
SMALL SPEECH DELAY AND HAD EARLY
INTERVENTIONS SERVICES AT HOME
AND LATER AT SCHOOL.
I WAS FORTUNATE TO FIND SUCH
PROGRAMS AVAILABLE TO US.
OUR CONTINUED PARTICIPATION ALSO
ALLOWED US BOTH TO TRY AND HAVE
SOME IMPACT ON OTHER FAMILIES
AND CHILDREN.
THE OLDER HE GOT, HE BECAME MORE
AWARE THAT HIS EXPERIENCES IN
LIFE WERE A SNAPSHOT OR A PEEK
INTO OTHER KIDS HIS ABLE FOR THE
RESEARCHERS.
THROUGH THE STUDY I'D EXPLAIN
PROGRAMS COULD BE DEVELOPED OR
FUNDING IMPACTED ON THINGS THAT
AFFECT OTHER KIDS AND FAMILIES
JUST LIKE HIS.
HE ENJOYED IT AND WE WOULD
DISCUSS SOME THINGS AFTER A
VISIT OR A CALL.
I NEVER AT ANY POINT WANTED TO
TAINT HIS THOUGHTS OR REPLIES
PRIOR THOSE VISITS.
ONE YEAR WE WERE ASKED TO
PROVIDE A DNA SAM PAP -- SAMPLE
AND WONDERED WHAT IT WOULD SHOW
OR UTILIZED IN THE FUTURE AND
DID OUR SPIT TUBES TOGETHER AND
SENT IT BACK HOPING TO HELP THE
STUDY.
HE WAS BECOMING A BETWEEN TOO
FAST.
IN A FLASH THE SURVEY OF PARENTS
AND TEENS WAS UPON US AND AFTER
MY HUSBAND HAD BECOME DISABLED
IN 2007, I STARTED TO CYBER
SCHOOL MY CHILDREN AT HOME AND
WORK PART-TIME OUTSIDE THE HOME.
THIS ALLOWED LUKE THE
OPPORTUNITY TO EXPLORE MANY
EDUCATIONAL INTERESTS ON HIS
OWN.
AS HE GOT OLDER THE SURVEY
FOLLOW-UPS ALLOWED HIM TO
PURCHASE CAMERA EQUIPMENT OR
COMPUTER COMPONENTS.
HE SHOWED A GIFT FOR PHOTOGRAPHY
AND BUILT A FEW PCs FROM THE
BOTTOM UP.
THIS HELPED ME GREATLY AND
TAUGHT HIM TO BETTER HANDLE HIS
OWN FUNDS.
HE OUTGREW THOSE EARLY DELAYS
VERY FAST AND WAS EXTREMELY
BRIGHT.
I WORRIED ABOUT COLLEGE LOOMING
IN THE FUTURE AND COMING
QUICKLY.
WE WERE ALWAYS HAPPY TO GET THE
UPDATES OR REQUESTS SO FAMILIAR
TO US NOW.
THEY MEANT IT WAS TIME TO HELP
THE RESEARCH TEAM AT PRINCETON
AND COLUMBIA.
WE WERE LIKE PIONEERS IN THE
SENSE AND HAD A PURPOSE.
DURING OUR FINAL INTERVIEW
DR. EDIN AND MAT CAME TO OUR
HOME.
THIS WASN'T USUAL AND SEEMED
SPECIAL.
THEY HAD US BOTH SIGN NEW
WAIVERS, TO BE TAPED DURING THE
VISIT AND HAD TO INVENT A NEW
NAME TO BE USED TO REMAIN
ANONYMOUS.
IT WAS EXPLAIN THE TAPES COULD
BE REVIEWED IN THE FUTURE BY
THOSE INVOLVED IN IMPACT AND
RESEARCHING FAMILIES LIKE OURS.
WE BOTH SPOKE FOR SEVERAL HOURS
AND UNDERSTOOD THE IMPORTANCE OF
IT ALL.
THOUGH IT COULD BE SAID OUR
FAMILY IS FRAGILE, WE CONTINUED
TO DO OUR BEST AND FIND WAYS TO
ACCOMPLISH OUR SHARED OR
SINGULAR GOALS.
LUKE'S NOW GRADUATED FROM
COLLEGE WITH HONORS, HAS A B.S.
IN MANAGEMENT INFORMATION
SYSTEMS.
HE WORKED ON THE COLLEGE
NEWSPAPER AS A PHOTOGRAPHER,
PHOTO EDITOR AND FINALLY AS
THEIR BUSINESS MANAGER.
HE CONTINUES TO DO PHOTOGRAPHY
AND VIDEO WORK IN IN HIS FREE
TIME WHILE WORKING FOR A MAJOR
CORPORATION IN PHILADELPHIA THAT
HAS A GLOBAL FOOTPRINT.
HE MOVED OUT OF OUR HOME TWO
YEARS AGO AND AMAZES ME.
ALL CHILDREN DO TRUTHFULLY.
IT'S WHY I AGREED TO CONTINUE
THIS FOR 25 YEARS WITH MY SON.
I WANT MY CHILDREN AND ALL OF
OUR CHILDREN TO HAVE WHAT THEY
NEED IN ORDER TO BECOME
PRODUCTIVE CITIZENS OF THIS
COUNTRY.
THE FUTURE IS BASED ON THE
SUCCESS OF OUR YOUTH.
THE CHILDREN IN THIS STUDY ARE
NOW CALLED GEN Z.
LET'S SEE WHERE THEY GO.
I APPRECIATE YOU ALLOWING ME
THIS TIME TODAY AND HOPE THE
RESEARCH PRESENTED AS WELL AS
WHAT YOU CAN LEARN FROM MYSELF,
MY SON AND ALL THE PARTICIPANTS
IN THE STUDY ENLIGHTENS YOU.
WE MUST CONTINUE TO HELP
CHILDREN ATTAIN THE BEST
POSSIBLE OUTCOMES IN THEIR
LIVES.
IT TRULY BENEFITS US ALL.
I THANK YOU FOR YOUR OWN EFFORTS
ON BEHALF OF THESE IMPORTANT
TOPICS AS WELL AS CONTINUED
FUNDING OF PROGRAMS OR RESEARCH
THAT IMPACT THE FUTURE OF
CHILDHOOD DEVELOPMENT.
THANK YOU VERY MUCH FOR YOUR
TIME.
>> YOU SEEM SO CALM FOR RAISING
FIVE CHILDREN.
>> I HAVE ALL BOYS AND ONE
DAUGHTER.
>> I'M GRATEFUL TO PEOPLE WHO
SET ASIDE THEIR TIME AND YOU'VE
EXPRESSED INCREDIBLE COMMITMENT
OVER LUKE'S LIFE TIME.
THAT'S PRECIOUS.
WE ALL THANK YOU.
>> THANK YOU, HAVE A WONDERFUL
REST OF DAY.
>> THANK YOU, YOU AS WELL.
OKAY.
CONTINUING WITH THE THEME OF BIG
DATA, WE NOW HAVE DR. REBECCA
ROSEN NOT TO BE CONFUSED WITH
DR. RASOOLY FROM THE OFFICE OF
DATA SCIENCE AND SHARING.
SHE'S GOING TO REPORT ON HER
OFFICE'S ACTIVITIES IN DATA
SCIENCE AND SHARING AND HOW THAT
FACILITATES THE APPROPRIATE USE
OF ARTIFICIAL INTELLIGENCE IN
RESEARCH.
I'M ONLY SEEN YOU ON ZOOM THE
LAST FEW YEARS.
GREAT TO SEE YOU IN PERSON.
>> I WANT TO THANK THE FOLKS
BECAUSE THAT'S WHY WE'RE HERE.
>> PUT YOUR MICROPHONE UP TO
HEAR YOU BETTER.
>> I WANTED TO SAY THANK YOU
AGAIN FOR HAVING ME BACK HERE.
I PRESENTED LAST JANUARY AND
IT'S AN HONOR AND UNIQUE
OPPORTUNITY TO BE ABLE TO
PRESENT TO OUR ADVISORY COUNCIL
AN UPDATE ON DATA STRATEGY AND
ACTIVITIES SINCE THAT
PRESENTATION OF JANUARY 2023.
NICHD IS COMMITTED TO PROMOTING
DATA SHARING TO ACCELERATE
SCIENTIFIC PARTNERS.
THE STRATEGIC STEWARDSHIP GOAL
TWO OF OUR STRATEGIC PLAN
SCIENTIFIC STEWARDSHIP IS TO
FACILITATE DATA SHARING AND
ACCESS TO BIO SPECIMENS AND
WHERE OUR OFFICE WAS ESTABLISHED
THE OFFICE OF DATA SCIENCE AND
SHARING IN JULY OF 2021.
OUR TEAM DESIGN A REVISION AND
INNOVATIVE USE OF DATA AND
SPECIMENS THAT ACCELERATED
RESEARCH AND IMPROVES THE HEALTH
OF NICHD POPULATIONS.
VALERIE PATTON IS MY DEPUTY
DIRECTOR AND OUR TEAM MEMBERS,
ELIZABETH CLERKIN HAVE DONE MOST
THE WORK I PRESENT TODAY SO I
WANT TO THANK THEM VERY MUCH.
THE THEME OF MY TALK TODAY IS
OUR COMMITMENT TO HUMAN CENTERED
DESIGN FOR OUR DATA STRATEGY.
EVERYTHING WE DO IS DESIGN TO
ADDRESS NICHD COMMUNITY LEADS.
WE DEVELOPED RESOURCES AND TOOLS
TO ENABLE DATA SHARING AND DATA
SCIENCE ACROSS THE DATA OF LIFE
CYCLES AND DO THAT WITH THE ONE
NICHD APPROACH.
AT NICHD WE HAVE EXTRAMURAL AND
INTRAMURAL DATA SHARING
COMMITTEES AND THEY ADVISE ON
OUR IMPLEMENTATION OF POLICIES
AND ONE NICHD WIDE ECO SYSTEM
WORKING GROUP AND ADVISE ON OUR
STRATEGY FOR BUILDING OUT AND
CONNECTING OUR DATA RESOURCE.
THESE NICHD ADVISORY GROUPS ARE
COMPRISED OF STAFF MEMBERS WHO
REPRESENT THE BROAD RESEARCH
PORTFOLIO AND WORK WITH OFFICE
OF DIRECTOR COLLEAGUES THAT
INCLUDES COMMUNICATIONS, HEALTH
EQUITY AND GLOBAL HEALTH, PUBLIC
POLICY AND ETHICS AND SCIENCE
POLICY REPORTING AND ANALYSIS.
AS THEY'RE THEIR OFFICE
SUBMISSIONS OFFICE OFTEN
SYNERGIZE AND COLLABORATE WITH
OUR OFFICES AND THE OFFICE OF
DATA SCIENCE STRATEGY AND THAT
HELPS US TO ENSURE
INTEROPERABILITIES AND
CONSISTENT IN INTERNAL AND
EXTERNAL GUIDANCE.
OUR DATA SHARING ACTIVITIES ARE
FOUNDATIONAL TO THE RESPONSIBLE
AND INNOVATIVE DEVELOPMENT AND
USE OF MACHINE LEARNING AND
ARTIFICIAL INTELLIGENCE
TECHNOLOGIES FOR NICHD RESEARCH.
THAT'S A CORE THEME I WANT TO
GET ACROSS TODAY.
WE'RE DOING A LOT OF WORK IN
THIS SPACE BECAUSE DATA AND DATA
SCIENCE ARE FOUNDATIONAL FOR
A.I.
ACROSS THE FEDERAL GOVERNMENT
WE'RE ESTABLISHING FRAME WORKS
AND RESOURCES FOR THE
RESPONSIBLE DEVELOPMENT OF A.I.
IN OCTOBER 2023 THE
ADMINISTRATION RELEASED AN ORDER
OUTLINE AN APPROACH FOR SECURE,
SAFE AND TRUST WORTHY ARTIFICIAL
INTELLIGENCE AND MAXIMIZE THE
VALUE AND REDUCING THE RISK
ASSOCIATED WITH THE TECHNOLOGY
TO THE AMERICAN PEOPLE.
IN RESPONSE TO THIS ORDER THE
OFFICE OF MANAGEMENT AND BUDGET
RELEASED A MEMO IN MARCH 2024
THAT ADVISES FEDERAL AGENCIES ON
OUR DEVELOPMENT AND TIMELY
IMPLEMENTATION OF STRATEGIES.
NIH IS WORKING WITH THE
DEPARTMENT OF HEALTH AND HUMAN
SERVICES ON THE NEW A.I. TASK
FORCE UNDER THE CHAFE A.I.
OFFICER AND INSIDE NIH OUR
COLLEAGUES AT THE STRATEGY
RELEASED A DRAFT STRATEGY PLAN
FOR NIH FOR FEEDBACK FROM THE
COMMUNITY AND THIS PLAN INCLUDES
STRATEGY GOALS AND ACTIVITIES
THAT WILL BECOME THE CORNERSTONE
OF THE STRATEGY THAT ALIGN WITH
THE A.I. STRATEGY.
TO THE VOLUME AND DIVERSITY OF
NEW DATA SHARED UNDER THE NIH
DATA MANAGEMENT POLICY IS A
WATERSHED MOMENT FOR THE
RESPONSIBLE DEVELOPMENT AND USE
OF A.I. FOR NICHD RESEARCH.
SOON AFTER THIS POLICY WENT INTO
EFFECT WE ANALYZED THE FIRST
ROUND OF DATA MANAGEMENT AND
SHARING PLANS THAT CAME IN AND
DEVELOPED AND PUBLISHED ON OUR
WEBSITE SIMPLE TIPS FOR WRITING
AN ACCEPTABLE AND IMPLEMENTABLE
SHARING PLAN AND THESE ALIGN
WITH KEY EXPECTATIONS WRITTEN IN
THE NIH POLICY FROM THE OFFICE
OF SCIENCE POLICY AND MAP TO A
GUIDANCE ON THE ELEMENTS OF DATA
MANAGEMENT AND SHARING PLAN.
AT NICHD WE'RE FOCUSSED ON
IMPLEMENTING THE POLICY AS
WRITTEN AND HAVE NOT ADDED
SPECIFIC RECOMMENDATIONS.
OVER ALL THE POLICY EXPECTS
RESEARCHERS MAXIMIZE THE
APPROPRIATE SHARING OF
SCIENTIFIC DATA USING
ESTABLISHED DATA REPOSITORIES
AND SHARING NO LATER THAN THE
END OF THE AWARD PERIOD.
IT IS POSSIBLE THERE ARE
APPROPRIATE LIMITATIONS FOR DATA
SHARING.
THE POLICY ACKNOWLEDGES THAT BUT
EXPECTS RESEARCHERS JUSTIFY THE
LIMITATIONS, STAFF ARE
APPROPRIATELY REVIEW THE PLANS
AND JUSTIFICATIONS FOR ANY
STATED LIMITATIONS.
I'VE ADDED HERE THE POLICIES
WHAT I BELIEVE IS AN ELEGANT
DEFINITION AND NICELY
GENERALIZABLE AND THE ACT OF
MAKING DATA OF USE BY OTHERS AND
THE INSTITUTIONS AND IMPORTANTLY
THE BROADER PUBLIC.
FOR EXAMPLE, VIA AN ESTABLISHED
REPOSITORY AND THAT WILL BE A
THEME FOR ME TODAY.
WE'RE A LITTLE FURTHER IN NOW
AND HAVE SEEN MORE PLANS.
WE WORKED WITH OUR DATA SHARING
COMMITTEES TO REVIEW A SUBSET OF
ALL THE PLANS THAT HAVE COME IN
SINCE THE POLICY WENT INTO
EFFECT IN JANUARY OF LAST YEAR
AND WE HAVE IDENTIFIED SOME
COMMON ISSUES THAT WE ARE SEEING
ACROSS THE PLANS AND WORKING
TOGETHER BECAUSE THIS IS HARD TO
DO.
SO WE REVIEW THE PLANS TO
IDENTIFY COMMON ISSUES TO INFORM
UPDATES TO THOSE TIPS I JUST
DESCRIBED.
HERE ARE COMMON ISSUES.
WE SAW CHALLENGES WITH USING THE
NIH PROVIDED FORMAT PAGE AND
THAT WILL LEAD TO INCONSIST
INCONSISTENCIES.
AND THE DESCRIPTION WERE NOT
CLEAR AND LACK SUFFICIENT
DETAILS ABOUT THE STANDARDS AND
OTHER INFORMATION THAT PROGRAM
OFFICERS NEED TO ASSESS THE
PLANS.
SOME PLANS JUST DID NOT MEET THE
POLICY DEFINITION OF DATA
SHARING WHICH IS WHY I
HIGHLIGHTED THAT IN THE PREVIOUS
SLIDE.
RESEARCHERS MAY PLAN TO SHARE
DATA AT CONFERENCES OR
PUBLICATIONS OR SHARE ON REQUEST
WHICH IS NOT IN THE SPIRIT OR
DEFINITION OF NIH DATA SHARING.
WE ALSO DID SEE VAGUE LANGUAGE
ON JUSTIFIABLE LIMITATIONS FOR
SHARING DATA AND IT'S NOT
SUFFICIENT FOR OUR PROGRAM STAFF
TO ASSESS THE PLAN'S ACCEPTABLE.
WE SHARE THESE FINDINGS AND THE
RESULTING GUIDANCE WE DEVELOPED
FOR WRITING BETTER PLANS WITH
NICHD INTERNALLY AND COLLEAGUES
AND IN PUBLIC VENUES.
MOST RECENTLY VALERIE COTTON
PRESENTED THESE AND OTHER SLIDES
TO RESEARCH INSTITUTION
ADMINISTRATORS AND FACULTY AT
THE FEDERAL DEMONSTRATION
PARTNERSHIP AT THE ANNUAL
MEETING LAST MONTH.
IT'S A LONG-RUNNING
PUBLIC-PRIVATE PARTNERSHIP THAT
COLLABORATE ON HOW TO STREAMLINE
THE ADMINISTRATION OF FEDERALLY
FUNDED RESEARCH AND WE'RE
CONTINUING TO COLLABORATE WITH
THE OFFICE OF EXTRAMURAL
RESEARCH WHICH LED THE PANEL
THAT VALERIE PRESENTED ON AND
THE FVP ON THE IMPLEMENTATION OF
THIS POLICY.
WE'RE PUBLISHING ON OUR WEBSITE
EVERYTHING I'M TALKING ABOUT AND
PLORE.
WE PUBLISHED THOSE UPDATED TIPS
FOR WRITING THE DATA MANAGEMENT
AND SHARING PLAN AND PUBLISHED A
DATA REPOSITORY FINDER TO ENABLE
IDENTIFICATION OF ACCEPTABLE
REPOSITORIES FOR SHARING DATA, A
SET OF EXAMPLE PLANS THAT HAVE
ALSO BEEN PUBLISHED ON THE
CENTRAL NIH DATA WEBSITE AND A
WEBSITE ON DATA STANDARDS AND
PUBLISHED ADDITIONAL RESOURCES
AND ALWAYS KEEPING THIS UP TO
DATE.
I DO ENCOURAGE YOU TO VISIT THE
WEBSITE AND SHARE THEM WITH THE
RESEARCHERS AND ADMINISTRATOR
COMMUNITIES.
LOOKING INTO THE DATA STANDARDS
WEB PAGE.
WHEN WE SAW THE ASSESSMENT
THERE'S A NEED TO BETTER
DESCRIBE WHAT DATA STANDARDS ARE
AND WHY THEY'RE RELEVANT AND HOW
TO BE IMPLEMENTED.
ON THE PAGE WE PROVIDE AN
OVERVIEW AND MAINTAIN A RUNNING
LIST OF METADATA STANDARDS AND
MODELS AND THIS DEMONSTRATES OUR
DATA STANDARDS AND HOW THEY ARE
IMPLEMENTS ACROSS THE RESEARCH
AND DATA LIFE CYCLES.
ON THE RIGHT SIDE OF THE SLIDE
MY OFFICE OVERSEES THE NICHD
DATA AND SPECIMEN HUB.
AS MOST KNOW IT'S A CONTROLLED
ACCESS DATA REPOSITORY THAT
HELPS US SUPPORT DATA MANAGEMENT
SHARING COMPLIANT SHARING FOR
OUR NICHD STUDIES AND SPECIMEN
SHARING FOR A SUBSET.
I WAS DEVELOPED IN 2015 BY THE
DIVISION OF EXTRAMURAL RESEARCH
AND THE I.T. MANAGEMENT BRANCH
AND THIS IS A REMEMBER DATA
DICTIONARY THAT ENABLES
RESEARCHERS TO ANNOTATE THEIR
MEANINGS IN THEIR DATA SET IN A
MACHINE READABLE MANNER AND NAME
THE STANDARDS THEY USED IN DATA
COLLECTION OR HARMONIZATION AND
PROVIDE LINKS TO A WEBSITE OR
OTHER IDENTIFIER FOR THE
STANDARD.
THIS ALLOWS SECONDARY USERS TO
INTERPRET THE DATA SETS SHARED
UP DASH AND HARMONIZE WHEN
APPROPRIATE SHARED DATA SETS.
DASH IS ONE OF MANY DATA
REPOSITORIES WHERE EXTRAMURAL
AND INTRAMURAL RESEARCHERS SHARE
DATA.
WE'RE TRACKING ALL THE SYSTEMS
THAT ARE INTRAMURAL AND
EXTRAMURAL RESEARCHERS ARE
NAMING SO WE CAN DETECT PATTERNS
TO HELP PROVIDE BETTER GUIDANCE
TO OUR COMMUNITIES.
THE GRAPH HERE IS AN ANALYSIS
SUBMITTED FOR THE EXTRAMURAL
GRANT APPLICANTS.
WHAT YOU SEE ON THE Y AXIS ARE
EACH OF THE SYSTEMS NAMED IN THE
PLANS AND ON THE X AXIS IS THE
NUMBER OF PLANS THAT MENTION THE
GIVEN SYSTEM.
THE BARS ARE DIFFERENT BECAUSE
THERE'S AN ELEMENT OF THE PLAN
WE'RE SUPPOSED TO NAME THE
REPOSITORY AND NAME RESEARCHERS
IN THE PLAN WHICH GOES TO THE
INCONSISTENCY USING THE
TEMPLATE.
WE DO SEE THE ORANGE BAR
MENTIONS AND THE BLUE BAR IS
INCLUSIVE OF ELEMENT FOUR.
WE SEE GOOD PATTERNS IN
REPOSITORY USE.
MANY PLAN TO USE ESTABLISHED
DATA REPOSITORIREPOSITORIES.
WE'RE SEEING REPOSITORIES THAT
DON'T ALIGN WITH THE POLICY
WHICH POINTS TO A PUBLICATION OF
SCIENCE OF TECHNOLOGY POLICY ON
DESIRABLE CHARACTERISTICS OF
DATA REPOSITORIES FOR FEDERALRY
FUNDED RESEARCH.
WE ALL LOVE GITHUB BUT IT'S NOT
A DATA REPOSITORY.
IT DOES NOT HAVE DATA CURATION
PROCESSES OR A SEARCH INTERFACE
FOR FINDABILITY.
WE ALL LOVE PUB MED.
IT'S AN INTERNATIONALLY
RECOGNIZED RESOURCE FOR
SCIENTIFIC RESEARCHER AND NOT A
DATA REPOSITORY AND SHARING DATA
WITHIN PUBLICATIONS DOES NOT
ALIGN WITH THE SHARING POLICY
EXPECTATIONS AND THE DEFINITION
OF DATA SHARING.
TO SUCCESSFULLY IMPLEMENT OUR
SYSTEM WE HAVE TO ALIGN TO OUR
CHARACTERISTICS AND RESEARCHERS
NEED AND NEED TO CONNECT TO ONE
ANOTHER AND TO TOOLS.
I INTRODUCED OUR HUMAN-CENTERED
DESIGN APPROACH TO FILLING OUT
THE DATA ECO SYSTEM.
MA
HUMAN CENTERED DESIGNS ARE
ADDRESSING THE NEEDS.
WE WORKED WITH OUR WORKING GROUP
TO LOOK AT WHERE THEY'RE SHARING
DATA OR ACCESSING DATA FOR
SECONDARY USE AND DEVELOPED AND
IMPLEMENTED A REPOSITORY
ASSESSMENT PROTOCOL USING
METRICS AND FRAME WORKS TO
ASSESS EACH REPOSITORIES
ABILITIES TO SUPPORT THE DATA
MANAGEMENT AND SHARING POLICY TO
ENABLE USERABILITY OF THE DATA
AND LONG TERM SUSTAINABILITY AND
DOCUMENT THE DATA GOVERNANCE AND
SECURITY PROTOCOLS.
THIS INFORMATION IS HELPING MAKE
STRATEGIC DECISIONS ABOUT OUR
DATA SCIENCE AND SHARING
PROGRAMS.
IN PARALLEL TO OUR REPOSITORY
ASSESSMENT WE DEVELOPED,
IMPLEMENTED AND PUBLISHED A USER
STORY FORMAT WE'RE USING TO
COLLECT AND PRIORITIZE USER
STORIES FROM OUR NICHD
COMMUNITIES TO INFORM DESIGN.
WE SHARED TOOLS WITH OFFICES.
AND OF COURSE WE COORDINATE
AGAIN WITH THE NIH OFFICE OF
DATA SCIENCE STRATEGY AND
COLLEAGUES SO THAT WE IN OUR
COMMUNITIES CAN LEVERAGE OTHER
STANDA
STANDARDS, TOOLS AND TRAININGS
BEING DEVELOPED.
THE WORK WE NEED TO DO TO
ADDRESS MANY USER STORIES
INVOLVES THE DEVELOPMENT OF
THREE TYPES OF INTEROPERABILITY
ACROSS THE RELEVANT DATA
RESOURCES, GOVERNANCE, DATA AND
SYSTEM INTEROPERABILITY AND
RULES AND CONTROLS THAT DEFINE
DATA COLLECTION ACCESS, SHARING
AND LINKAGE AND USE.
GOVERNANCE INOPERABILITY IS TO
UNDERSTAND HOW DATA SETS COULD
BE INTEGRATED.
DATA INTEROPERABILITY GOES TO
CO-ANALYZE DATA FROM DIFFERENT
STUDIES BASED ON THE MEANING AND
STRUCTURE OF THE DATA AND
ACHIEVED THROUGH THE USE OF DATA
STANDARDS AT THE EARLY STAGES OF
DATA COLLECTION AND ALSO IN THE
DOCUMENTATION AND IMPLEMENTATION
OF A STANDARD OF SHARING DATA
REPOSITORIES.
DUE TO OTHER RESOURCES COULD BE
INTEROPERABLE THROUGH THE USE OF
WEB SERVICES AND OTHER
TECHNOLOGY STANDARDS THAT ALLOW
DATA SYSTEMS TO TALK TO ONE
ANOTHER ABOUT PEOPLE, THEIR
USERS AND THE DATA THEY HAVE AND
THE PROCESSES THEY ENABLE.
FOR EXAMPLE, WITH SYSTEM
INTEROPERABILITY A RESEARCHER
CAN MOVE AROUND AND GET DATA
FROM MULTIPLE REPOSITORIES INTO
A SINGLE COMPUTING ENVIRONMENT
FOR COLLABORATION BASED ON
SYSTEM INTEROPERABILITY
STANDARDS.
WE COMPLETED SEVERAL EFFORTS FOR
GOVERNANCE IN THE NICHD ECO
SYSTEM BASED ON THE USER
COMMUNITY NEEDS.
FOR THE REMAIN DDER OF THE TALK
I'LL TALK ABOUT THE HUMAN
CENTERED DESIGN.
IT'S TO COLLECT STORIES FROM
PARTICIPANTS, DEVELOPERS, POLICY
LEADERS AND OTHER NICHD
STAKEHOLDERS.
OUR USER STORIES ARE STRUCTURED
TO IDENTIFY THE USER, WHAT THEY
WANT TO DO, WHY, WHAT REAL OR
PERCEIVED BARRIERS EXIST AND
NEED TO BE NAVIGATED TO ACHIEVE
THEIR GOALS.
FOR EXAMPLE, IN ONE COVERT
RESEARCH EFFORT THE CLINICIAN
WANTED TO COMBINE DATA TYPES AND
AVOID WORKING WITH CONFLATED
SAMPLE SIZE AND LOOK AT GENOMIC
SEQUENCING.
WE ASKED USER TO TELL US WHY
THEY CAN'T ACHIEVE WHAT THEY
WANT TO DO AND ASKED THEM TO
SHARE THEIR GOAL TO CONSIDER
MULTIPLE SOLUTIONS TO ACHIEVE
THE GOAL AND PUBLISHED THE FIRST
ROUND OF THE ECO SYSTEM WORK ON
NIH GITHUB.
AND THIS INCLUDE USER STORIES
AND USE CASES AND CREATE
FUNCTIONAL REQUIREMENTS FOR NEW
WORK AND RELATED EFFORTS WE
COMPLETED TO MEET THOSE USER
STORIES OURSELVES OR WITH
COLLABORATORS.
WE DO SEE THE ECO SYSTEM WORK IS
GENERALLY APPLICABLE TO HIP
INSTITUTES AND THEIR
COMMUNITIES.
-- NIH INSTITUTES AND THEIR
COMMUNITIES AND IN SUPPORT OF
PEDIATRIC RESEARCH WE DETERMINED
PRIVACY PRESERVING LINKAGE COULD
BE IMPLEMENTED TO MEET THE
CLINICIANS STATED NEED.
THE TECHNOLOGY USES CRYPTOGRAPHY
TO ENCODE PARTICIPANT
INFORMATION SO THAT DATA SETS
ABOUT THE SAME PARTICIPANT CAN
BE LINKED WITHOUT REVEALING THE
PARTICIPANT'S PERSONAL
INFORMATION.
HOWEVER, WHILE THE TECHNOLOGY IS
RELATIVELY STRAIGHTFORWARD WE
FOUND GOVERNANCE CHALLENGES THAT
WARRANT A DEEPER DIVE ASSESSMENT
AND DEVELOPED A RECORD LINKAGE
IMPLEMENTATION CHECKLIST AFTER
LOOKING AT IMPLEMENTATIONS AND
DISTILLED TO IDENTIFY FIVE
GOVERNANCE AND THREE TECHNOLOGY
QUESTIONS THAT SHOULD BE
ADDRESSED BY A TEAM OF
RESEARCHERS AND DATA REPOSITORY
STEWARDS BEFORE PROVIDING WITH
LINKING AND USING LINK DATA FOR
RESEARCH.
THIS WORK TO DEVELOP THE
CHECKLIST WAS SUPPORT THE OFFICE
OF NIH DATA SCIENCE STRATEGY.
OUR SUBSEQUENT WORK IS NOW
FUNDED BY THE HHS PATIENT
CENTERED OUTCOMES RESEARCH TRUST
FUND.
ONCE WE DEVELOPED THIS WE WERE
ABLE TO DEMONSTRATE THE UTILITY
TO ADDRESS ANOTHER HIGH PRIORITY
NICHD USER STORY FOR DATA
LINKAGE FROM OUR COLLEAGUES AT
THE INCLUDE DATA COORDINATING
CENTER.
THERE WERE RESEARCH WITHIN THE
NICHD/NHLBI CO-LED
INFRASTRUCTURE FOR THE
INITIATIVE ON CRITICAL HEALTH
AND QUALITY OF LIFE NEEDS FOR
INDIVIDUALS WITH DOWNS SYNDROME.
THE INCLUDE STAKEHOLDERS WORKED
THROUGH EACH OF THE EIGHT
CHECKLIST ITEMS TO LINK DATA
SETS ACROSS THE DATA
REPOSITORIES.
THEY DETERMINED THE SCOPE AND
WHICH DATA SITS WOULD BE LINKED.
THEY DETERMINED TO THEY NEDDED
TO GAIN APPROVAL AND IT WOULD BE
BASED ON CONSENT AT NIH AND
PROGRAM PROVIDE APPROVAL.
AND THERE'S SPECIFIC POLICIES
RELATED TO THE PARTICIPANT
POPULATIONS AND THE POLICY CAME
UP AS WELL AS CONSENT BASED DATA
USE AND OTHER POLICIES THEY WERE
ABLE TO IDENTIFY AND THEN
DECIDED BASED ON THE ORDER.
WE LEARNED ABOUT WHAT RULES AND
POLICIES ARE ASSOCIATED AND NOW
DECIDE WHO SHOULD LINK THEIR
DATA AND DETERMINE RESEARCHERS
SHOULD BE ABLE TO LINK THE DATA
AND LEADS TO THE CONTROLS THEY
DECIDED TO PUT INTO PLACE TO
MITIGATE THE RISK WHICH IS THE
LINKAGES WOULD BE SHARED AFTER
APPROVAL AND PROHIBIT
REIDENTIFICATION AND THE DATA
SETS ARE SHARED FOLLOWING THE
PROTOCOLS.
THE TECHNOLOGY CONSIDERATIONS
ARE SIMPLER.
IF YOU LOOK THROUGH THE THREE
CHECKLIST ITEMS WHAT'S NEEDED IS
FOR THE SITES TO POST PERSONALLY
IDENTIFIABLE INFORMATION AND THE
TECHNOLOGY NEEDS TO MEET BASIC
REQUIREMENT FOR WHAT WAS
MENTIONED AND THE TOOLS SHOULD
BE SUSTAINABLE.
WE DON'T WANT TO LINK ON A TOOL
THAT GOES AWAY AND THE NIMHD
DATA ARCHIVES MEET ALL THESE AND
IS A LONG-RUNNING GOVERNMENT
OWNED AND OPERATED PRIVACY
PRESERVING RECORD AND MET THE
CONSIDERATIONS AND NOW IS BEING
USED TO LINK THE DATA ACROSS THE
INCLUDE DATA REPOSITORIES.
WE'VE HEARD FROM OUR RESEARCHERS
AND ALSO FROM OUR STAFF THEY
WANT TO BE ABLE TO EASILY FIND
BEST DATA REPOSITORIES FOR
COMPLYING WITH THE DATA SHARING
POLICY OR REVIEWING DATA
MANAGEMENT SHARING PLANS AND
VERIFYING RESEARCHERS USE
REPOSITORIES FOR THE DATA THEY
PLAN TO SHARE.
WE DEVELOPED THE DATA REPOSITORY
FINDER USING SOME OF THE
INFORMATION WE WERE PULLING OUT
OF OUR REPOSITORY ASSESSMENT.
IT'S A USER-FRIENDLY TOOLS THAT
ALLOWS RESEARCHERS TO SEARCH FOR
REPOSITORIES BY THE FACETS OF
THE DATA MANAGEMENT SHARING PLAN
TO NOT ONLY IDENTIFY
REPOSITORIES APPROPRIATE FOR THE
DATA AND SHARING THE PLANS
EASILY WITHOUT SEARCHING FOR THE
INFORMATION ON VARIOUS
REPOSITORY WEBSITES.
IT'S A RESEARCH ACTIVELY USED BY
RESEARCHER AND STAFF MEETINGS.
OUR RESEARCHERS ALREADY SHARE
LARGE VOLUMES OF DATA AND HUMAN
DERIVED GEENOMICS AND OTHERS DAA
AND THERE'S THE DATA HUB AND THE
KIDS FIRST DATA RESEARCH CENTER
AND THE SEQUENCE ARCHIVE TO
ADDRESS THE USER STORY TO ACCESS
AND COLLABORATIVE AREALLY
CO-ANALYZE THE DATA SETS FROM
THE REPOSITORIES WE WORKED WITH
THE TEAMS FROM EACH TO BUILD
STANDARDS BASED INTEROPERABILITY
TO RESEARCHERS CAN LOG INTO ONE
CLOUD BASED WORK SPACE AND PULL
IN DATA SETS AUTHORIZED TO
ACCESS FROM THE THREE DATA
REPOSITORIES ELIMINATING THE
NEED THE WORK SPACE AND THIS LED
TO A STANDARD AND EACH VERIFY
THE ACCESS PERMISSIONS AND THE
DATA REPOSITORY SERVICE FROM THE
GENOMICS AND HEALTH FOR SHARING
GENOMIC STUDY AND THE RESOURCE
COMING OUT OF THE HHS LED
EXCHANGE STANDARD.
SO WHERE IS THIS ALL GOING.
OUR ULTIMATE VISION IS TO
DEVELOP A BLUEPRINT TO GUIDE
BEST PRACTICES FOR REPOSITORIES
AND SYSTEMS TO MEET THE NEEDS OF
THE COMMUNITY AND AIM TO PROVIDE
THIS TO RESEARCHERS AND STEWARDS
TO ACCELERATE AND STANDARDIZE
WHERE POSSIBLE NEW WORK TO
BUILD, ENHANCE AND CONNECT DATA
SYSTEMS.
AS WE COMPLETE THE EFFORTS I
DESCRIBED TODAY WE WILL CONTINUE
TO WORK ON NEWER EFFORTS SO EACH
IS INFORMED WHERE POSSIBLE BY
EXISTING STANDARDS AND POLICIES
AND HELPS UNDERSTAND WHERE THE
STANDARDS AND POLICIES MIGHT
MAKE IT INTO THE BLUEPRINT WE
SHARE AS A JUST DESCRIBED.
THESE ARE SOME OF OUR NEW
PROJECTS ARE A PROTOTYPE AND
READINESS AND ANALYSIS OF
REPOSITORIES AND THE DEVELOPMENT
TO SUPPORT INTEROPERABILITY.
TRUE IT'S A JOURNEY TO IMPLEMENT
THE POLICY AND ACHIEVE THE FULL
VALUE OF RESPONSIBLE DATA
SHARING AND USE AND HEARD WHY
IT'S IMPORTANT.
I DESCRIBED KEY PROGRESS IN OUR
JOURNEY WE'RE ABLE TO MAKE WITH
OUR ONE NICHD APPROACH AND WILL
CONTINUE TO BUILD OUT CAPACITY
FOR DATA SHARING AND USE ACROSS
THE RESEARCH LIFE CYCLE.
IN THE INTEREST OF TIME I'LL
JUMP TO SAY WE'LL CONTINUE TO
SHARE RESEARCHER NEEDS AND
COLLABORATE ON NEW EFFORTS WITH
THE OFFICE OF THE DIRECTOR
COLLEAGUES NOT JUST ODSS BUT
SCIENCE POLICY AND EXTRAMURAL
RESEARCH AND WE'LL CONTINUE TO
COLLECT RESEARCHER AND COMMUNITY
USER STORIES TO INFORM ALL THE
WORK WE DO.
THANK YOU VERY MUCH AND I LOOK
FORWARD TO YOUR FEEDBACK.
>> REBECCA SAYS WE CAN TAKE ONE
QUESTION
>> DAMIEN.
>> THIS IS FANTASTIC ALL THE
WORK DONE AND TRYING TO
INTEGRATE ACROSS THE
COMPLEXITIES THAT ARE REALLY
HIGH.
THE ONE QUESTION I HAVE IS
LOOKING AT THE CURRENT DATA
MANAGEMENT PLANS AND RELATIVE TO
THE BUILD OUT OF STANDARDS,
COMMON REPOSITORIES LINKED, THE
LIST OF INFORMATION SEEMS TO
PRIMITIVE IN KNOWLEDGE BASED ON
THE USERS AND NOT REALLY DATA
PLATFO
PLATFORMS AND WHAT IS THE
EDUCATION PART TO GET THEM IN
THE NEW SYSTEM?
IT SEEMS LIKE A MISMATCH BETWEEN
WHAT PEOPLE THINK THEY KNOW
ABOUT DATA MANAGEMENT AND WHERE
YOU'RE TRYING TO TAKE THEM.
>> I DON'T THINK IT'S A HUGE
MISMATCH.
I DO ACKNOWLEDGE IT'S A JOURNEY
BUT WE'RE SEEING RESEARCHERS
USING THE DATA REPOSITORIES.
THEY'RE HUBS OF COMMUNITY.
ACTIVITY WHERE RESEARCH
COMMUNITIES ARE DEVELOPING AND
USING AND SHARING STANDARDS.
SO BY GOING TO THOSE
REPOSITORIES THEY CAN FIND OUT
MORE TO BE USED UPSTREAM.
WE HAVE MANY COMMUNITIES DOING
THIS A LONG TIME.
THE GENOMICS DATA SHARING POLICY
HAS BEEN IN EFFECT A DECADE.
I KNOW WE NEED TO ENHANCE THE
CAPACITY OF OUR ECO SYSTEM BUT
DON'T SEE THAT MUCH OF A
MISMATCH.
WE'RE LOOKING AT WHERE WE SEE
THE ISSUES AND ADVISING ON
SPECIFIC DETAILS TO BETTER MATCH
BUT AGAIN WE'RE NOT SEEING A
HUGE GOAL BETWEEN WHAT'S COMING
IN ON THE PLANS AND WHAT IS YET
TO BE UTILIZED IN THE DATA
SHARING.
DID I GET TO THE QUESTION?
>> I THINK SO.
YOU HIGHLIGHTED ON THE LIST OF
ALL THE REPOSITORIES FOLKS WERE
LISTENING WHICH AREN'T
REPOSITORIES.
.
>> SOME ARE AND SOME AREN'T.
.
>> YOU HIGHLIGHTED THAT.
MANY THE MAJORITY LOOKED LIKE
THEY WEREN'T REPOSITORY.
>> THAT'S WHY WE BUILT THE DATA
REPOSITORY FINDER AND BASED ON
WHAT WE'RE HEARING FROM STAFF
AND RESEARCHERS AND THOSE THAT
DON'T KNOW CAN LOOK TO THAT AND
IDENTIFY IT.
>> I THINK THE POINT YOU'RE
MAKING AND IT MAY BE AN NIH WIDE
ISSUE AND MANY ARE NODDING
BECAUSE IT'S PROBABLY AN NIH
WIDE ISSUE.
THERE'S A COUPLE THINGS THERE
AND PROBABLY SOMETHING NICHD IS
PROBABLY FURTHER AHEAD ON THAN
OTHERS.
WE ENGAGED IN BUILDING COMMON
DATA ELEMENTS AND ENGAGED IN
CURATING ONTOLOGIES AND GETTING
REPOSITORIES BETTER AND SOME
DON'T HAVE ANY THEY CAN USE THAT
IS LIMITED.
THE OTHER PIECE IS THAT AND IN
SOME VENUES WE'RE TRYING TO PUSH
MORE TO GET TO EDUCATION,
STANDARDS, ONTOLOGIES, CDEs.
WE TRY TO SHAPE THIS THROUGH THE
WAY WE INTERACT ACROSS THE NIH
TO GET TO BETTER SUSTAINABLE
DATA ECO SYSTEM THAT ALLOWS FOR
SECONDARY DATA USE AND LINKAGE.
WE STILL NEED TO GO MORE WORK
AND SOMETHING I THINK
DR. BERTAGNOLLI HAS SAID OVER
AND OVER AND OVER AGAIN.
WE NEED TO BE A LEADER IN BIO
INFORMATICS AND CONTINUE THE
TENURE IS A FOCUS FOR HER.
TO EMPHASIZE AND WE'RE BUILDING
WHAT WE CAN AT THE NIH WIDE
LEVEL I THINK WE CAN DO MORE.
>> THAT GOES BACK TO MY POINT.
EVERYTHING WE DO WE SHARE WITH
NIH BROADLY SO ACHIEVE AN
ECONOMY OF SCALE.
WE'RE SEEING REPOSITORIES EXIST.
WE JUST NEED THE EDUCATIONAL
COMPONENT OUT TO THE COMMUNITY
AND BRING RESEARCHERS TO THE
REPOSITORIES AND THE DASH
SUBMISSION WEB PAGE IS A GOOD
EXAMPLE WHERE WE SET UP ONE
PANEL FOR RESEARCHERS TO GO AND
SAY THIS IS WHAT IT MEANS TO
PREPARE DATA FOR SHARING IN
DASH.
THIS IS THE CODE BOOK AND HOW I
DO IT AND HOW I POINT TO
STANDARDS.
WE WANT THE NUCLEI OF BEST
PRACTICES IN THE DATA
REPOSITORIES THAT DO EXIST.
>> THANK YOU, REBECCA FOR YOUR
PRESENTATION AND WORK IN LEADING
THE OFFICE OF DATA SCIENCE AND
SHARING.
NOW DR. RASOOLY HAS INSTRUCTIONS
FOR OUR COUNCIL MEMBERS BRA --
BEFORE I TAKE MY NEXT BREAK.
WE'LL TAKE A BREAK TO ABOUT 3:00
THIS AFTERNOON BUT BEFORE YOU
LED FOR COFFEE OR BIO BREAK FOR
THE FIRST TIME WE'RE GOING TO
TAKE A COUNCIL PICTURE.
THE PHOTOGRAPHER IS HERE AND SET
UP AND READY.
PLEASE DO THAT AND THEN WE'LL
ADJOURN TO A BREAK.
>> OKAY.
PLEASE TAKE YOUR SEATS.
WE'RE APPROACHING THE HOME
STRETCH.
I KNOW IT'S BEEN A LONG DAY.
THANK YOU.
NOW WE'RE GOING TO HEAR A REPORT
FROM TWO WORKING GROUPS OF
COUNCIL.
FIRST WE'LL HEAR FROM THE
PREGNANT WOMEN AND LACTATING
WOMEN OR PRGLAC IMPLEMENTATION
WORKING GROUP.
WE ESTABLISHED THE GROUP IN 2023
TO MONITOR AND REPORT ON THE
IMPLEMENTATION OF THE
RECOMMENDATIONS FOR IMPROVING
FROTH AND RESEARCH ON SAFE AND
EFFECTIVE THERAPEUTICS FOR
PREGNANT AND LACTATING PEOPLE.
THE RECOMMENDATIONS CAME FROM
THE CONGRESSIONALLY MANDATED
PRGLAC WHICH WAS LED BY NICHD
AND ESTABLISHED AS PART OF THE
21st CENTURIES CURES ACT.
THE IMPLEMENTATION WORK GROUP OF
COUNCIL IS FOCUSSED ON PUTTING
THOSE IMPLEMENTATIONS INTO
PRACTICE AND CHAIRED BY
DOCTORS -- THE MIC JUST WENT
OUT.
DOCTORS CHRISTINA BUCCI-RECHTWEG
AND DR. ABDEL-RAHMAN.
DR. BUCCI-RECHTWEG IS THE HEAD
OF PEDIATRIC AND MATERNAL HEALTH
POLICY AT NOVARTIS
PHARMACEUTICALS AND HAS OVER 20
YEARS OF EXPERIENCE IN CLINICAL
DEVELOPMENT AND MEDICAL AFFAIRS
AS WELL AS IN REGULATORY AND
DEVELOPMENT POLICY.
SHE'S OVERSEEN THE DEVELOPMENT
AND IMPLEMENTATION OF CLINICAL
PROGRAMS IN THE EUROPEAN UNION
AND UNITED STATES AND A CURRENT
MEMBER OF THE NICHD ADVISORY
COUNCIL.
WE'VE BEEN GRATEFUL FOR HER
SERVICE ON THE ORIGINAL PRGLAC
AND COUNCIL.
DR. ABDEL-RAHMAN IS A PEDIATRIC
RESEARCHER WHO SERVES AS CHIEF
SCIENTIFIC OFFICER FOR DATA
SYNTHESIS.
NEWLY-FORMED KANSAS CITY
START-UP AND HELD A THE MISSOURI
CHOIR AND PEDIATRIC
PHARMACOLOGY.
>> I THINK WE HAVE SLIDES TO
PULL UP.
I DON'T SEE THEM ON MY END BUT
IF YOU SEE THEM LET ME KNOW AND
I'LL START.
YOU WHILE WE'RE GETTING THOSE
SLIDES PULLED UP.
IT'S A PLEASURE TO BE WITH YOU
AND IT'S A PLEASURE TO DISCUSS
THE IMPLEMENTATION WORKING
GROUP.
IF WE CAN GO TO THE NEXT SLIDE.
WHILE IT'S INTUITIVE TO THE
COUNCIL WE FELT BECAUSE OF THE
OPEN NATURE OF THIS MEETING IT
WOULD BE HELPFUL TO LEAD WITH A
FOUNDATIONAL PREMISE UNDER
PRGLAC AND THE RELATED
ACTIVITIES.
THAT IS INDIVIDUALS WHO HAVE
CHRONIC ILLNESSES GET PREGNANT
AND NURSE INFANTS.
OTHERWISE HEALTHY PREGNANT AND
LACTATES INDIVIDUALS FALL IL AND
DECISIONS REMAIN TO REMAIN ON
MEDICATIONS WAS UNDERSTANDING OF
RISKS AN BENEFITS BECAUSE THE
RELEVANT TRIALS AREN'T
CONDUCTED.
PROTECTING INDIVIDUALS THROUGH
RESEARCH RATHER THAN FOR
RESEARCH WAS ADVANCED BY SKIP
NELSON AS PART OF THE ETHICAL
FRAMEWORK FOR INCLUDING CHILDREN
IN RESEARCH AND THE CONCEPT IS
APPLICABLE TO POPULATIONS THAT
REMAIN UNDER REPRESENTED IN
CLINICAL TRIALS AND PREGNANT AND
LACTATING INDIVIDUALS.
SO WE'VE GOT A LITTLE HISTORICAL
CONTEXT AND STARTS IN 2016 WHEN
A REPUBLICAN FROM WASHINGTON AND
DEMOCRAT INTRODUCED THE SAFE
MEDICATIONS FOR MOMS AND BABIES
ACT INTEGRATED INTO THE 21st
CENTURIES CURE.
AS PARTS OF THE LEGISLATION
DEPARTMENT OF HEALTH AND HUMAN
SERVICES WAS REQUIRED TO REPORT
ON THE DEVELOPMENT OF SAFE AND
EFFECTIVE THERAPIES FOR PREGNANT
AND LACTATING WOMEN, ETHICAL
ISSUES SURROUNDING THE INCLUSION
OF PREGNANT AND LACTATING WOMEN
IN FEDERAL RESEARCH AND
ACTIVITIES FOCUSSED ON PREGNANT
AND LACTATING WOMEN AND REPORT
ON APPLICATIONS, APPROVALS AND
LABELLING CHANGES RELEVANT TO
PREGNANT AND LACTATING WOMEN.
FROM 2017 TO 2017
REPRESENTATIVES FROM A MULTED
TOO OF AGENCIES CONVENED AS A
TASK FORCE TO LAY OUT 15
RECOMMENDATIONS AIMED AT THE
INCLUSION OF PREGNANT AND
LACTATING WOMEN AND INCLUDED
ACADEMIA AND PROFESSIONAL
ORGANIZATIONS WITH THE GOAL OF
DRAFTING AN IMPLEMENTATION PLAN
FOR THE ORIGINAL
RECOMMENDATIONS.
THE RELESS -- RELEASE OF THE
PLAN STIMULATED RESOURCES IN THE
CONSOLIDATED APPROPRIATIONS ACT
TO CREATE A WORKING GROUP,
COMMITTEE, TO MONITOR AND REPORT
ON THE IMPLEMENTATION THE FOCUS
OF THE SESSION, THE MEMO YOU
HAVE BEFORE YOU AND THE IMMINENT
REPORT RELEASED LATER THIS
MONTH.
NEXT SLIDE, PLEASE.
I'LL REFER YOU TO THE MEMO DATED
MARCH 2024 FOR THE DETAIL OF THE
LANGUAGE OF THE RECOMMENDATIONS
ALONG WITH SUBRECOMMENDATIONS
AND THOSE JOINING VIRTUALLY CAN
DETAIL THE RECOMMENDATIONS ON
THE NICHD'S WEBSITE.
FOR THOSE INTERESTED IN THE
LEGISLATIVE LANGUAGE YOU CAN
FIND IT ON THIS SLIDE.
THIS ONE WITH THE NICHD STAFF
AND OTHERS.
THIS SMALLER GROUP SET THE
STRUCTURE FOR THE MEETING.
WE IDENTIFIED THE INVIDEES WHO
CAN BEST SPEAK TO PROGRESS AND
THE BROADER WORKING GROUP WAS
COMPRISED OF REPRESENTATIVES
FROM ACADEMIA AND PROFESSIONAL
ORGANIZATIONS TASKED WITH
DELIBERATING ON THE INFORMATION
SHARED AND CONTRIBUTING
KNOWLEDGE FROM INDIVIDUAL
SECTORS AND INTRODUCING
ADDITIONAL CONSIDERATIONS TO
FACILITATE AND IT WILL BE
REFLECTED IN THE FINAL REPORT.
TO FACILITATE THE ORGANIZATION
OF OUR MEETINGS THE
RECOMMENDATIONS WERE IN FIVE
CLUSTERS AS DEFINED ON THE
SLIDE.
AND THESE CLUSTERS WERE REVIEWED
DURING TWO VIRTUAL MEETINGS AND
ONE IN PERSON MEETING.
I THINK IT'S ALSO IMPORTANT TO
POINT OUT THAT BECAUSE OF OUR
EXPRESSED TIME LINE THERE WAS A
SIZABLE AMOUNT OF OFFLINE
ACTIVITY THAT TOOK PLACE AMONG
WORKING GROUP MEMBERS BETWEEN
MEETINGS.
DISCUSSIONS CLUSTERED AROUND
CLUSTER A AND E WERE LARGELY
INFORMED BY SPEAKERS BY NIH.
CLUSTER B DEALT WITH TRAINING
AND CAREER DEVELOPMENT WE
ENGAGED NICHD WITH THE CENTERS
FOR DISEASE CONTROL AND
PREVENTION, THE SOCIETY FOR
MATERNAL AND FETAL MEDICINE AND
MOTHER TO BABY AND THE USDA WAS
ENLISTED TO SPEAK AND THROUGH A
SEPARATE AD HOC MEETING WE
SCHEDULED A MEET WITH MEMBERS
OFF THE NATIONAL ACADEMIES
SCIENCES ENGINEERING MEDICINE
COMMITTEE WHO AUTHORED THE
RECENTLY PUBLISHED FRAMEWORK TO
ADDRESS LEGAL, ETHICAL AND
POLICY ISSUES AND CLUSTER C WAS
ADDRESSED BY REPRESENTATIVES
FROM THE FDA, THE DEPARTMENT OF
HEALTH AND HUMAN SERVICES AND
THE OFFICE OF THE NATIONAL
COORDINATOR FOR THE CENTER FOR
MEDICAID AND MEDICARE SERVICES.
WE RECOGNIZED THE ACTIVITIES
HERE DO NOT CONSTITUTE THE
TOTALITY OF THE WORK IN THE AREA
BUT A COMPREHENSIVE REVIEW
WASN'T FEASIBLE WITHIN THE TIME
CONSTRAINTS.
I'M NOT GOING TO TURN IT OVER TO
YOUR COUNCIL COLLEAGUE CHRISTINA
TO DISCUSS THE FINDINGS OF THE
WORKING GROUP.
>> THANK YOU, SUE.
BEFORE WE MOVE INTO MORE OF THE
DETAILS RELATED TO THE
RECOMMENDATIONS, WE WANTED TO
HIGHLIGHT FOR YOU IF IT'S CLEAR
AS WE REVIEWED THROUGH THE OVER
ARCHING RECOMMENDATIONS AND
SUBRECOMMENDATIONS THERE WERE
KEY OVER ARCHING THEMES THAT
RESONATED THROUGH.THERE WAS A
NEED TO BE DISTINCTION PLACED
RESEARCH FOR PREGNANT WOMEN AND
FOR LACTATING WOMEN.
SOME RECOMMENDATIONS HAD SEEN
DIFFERENT DEGREES OF PROGRESS
DEPENDING IF THE FOCUS OF THE
DISCUSSION WAS ON THE PREGNANT
POPULATION OR LACTATING
POPULATION.
THE SECOND KEY THEME IS CERTAIN
RECOMMENDATIONS STRUGGLED WITH
IMPLEMENTATION AS THERE OFTEN
TIMES WOULD BE MULTIPLE
STAKEHOLDERS THAT WOULD NEED TO
BE ENGAGED FOR THE
RECOMMENDATIONS TO BE CARRIED
OUT AND.
ASSIGNMENT IN ORDER TO SEE THOSE
MOVE FORWARD.
AND THAT TAKES US TO THE THIRD
THEME AND THERE WERE NUMEROUS
RECOMMENDATIONS THAT CALLED FOR
ENGAGING MULTIPLE DIVERSE
STAKEHOLDERS AND NICELY GOES
WITH THE THEMES DISCUSSED EVEN
THIS MORNING ABOUT DATA SHARING
AND THERE'S A REAL NEED TO BE
COHESIVE CALLOUTS DUE TO
PREGNANT AND LACTATING
POPULATIONS TO STRENGTHEN AND
MOVE FORWARD ANY FUTURE LOOKING
PRIVATE-PUBLIC PARTNERSHIPS THAT
NEED TO COME UNDER THE
RECOMMENDATIONS HIGHLIGHTED BY
THE PRGLAC TASK FORCE.
THE FOURTH THEME WE SAW IS SOME
RECOMMENDATIONS TO BE
IMPLEMENTED MAY REQUIRE
ADDITIONAL RESOURCES AND/OR TO
IMPLEMENT GRANTING NEW
AUTHORITIES AND MAY REQUIRE SOME
CONGRESSIONAL ACTION.
THE FIFTH THEME IN REVIEWING THE
RECOMMENDATIONS IS THAT MANY OF
THESE RECOMMENDATIONS ARE EITHER
JUST BEGINNING IMPLEMENTATION OR
IN PROGRESS OR HAVE YET STARTED.
THEREFORE WILL THIS WORK GROUP
WAS ASSESSED FOR THE STATUS
REPORT AT PRESENT THERE WILL BE
A NEED FOR CONTINUING ASSESSMENT
TO ENSURE THE IMPLEMENTATION IS
ABLE TO FULLY MOVE FORWARD.
WITH THAT DISCUSSION ON THE OVER
ARCHING THEMES IDENTIFIED I'D
LIKE TO TURN TO MORE SPECIFIC
DISCUSSION.
AND A WORK GROUP OF COUNCIL IN
ORDER TO ACCOMPLISH THIS TASK,
DID REVIEW THE DIFFERENT
RECOMMENDATIONS FROM THE PRGLAC
TASK FORCE IN CLUSTERS.
I'LL PROVIDE TO YOU AN OVERVIEW
OF THE IMPLEMENTATION TO DATE
REGARDING THE CONDUCT OF
CLINICAL RESEARCH AND TRIALS
FOUND UNDER OUR DISCUSSIONS IN
CLUSTER A AND NOVEL DRUG
DISCOVERY FOUND IN
RECOMMENDATIONS WE DISCUSSED IN
CLUSTER E.
AND WHAT YOU'LL SEE AND THIS
WILL BE THE CASE FOR THE NEXT
SEQUENCE OF SLIDES WE PLACED
EACH OF THE SUBRECOMMENDATIONS
UNDER THE 15 RECOMMENDATIONS OF
THE TASK FORCE INTO DIFFERENT
STATUS BUCKETS.
EITHER IMPLEMENTED, IN PROGRESS
OR NOT YET IMPLEMENTED.
THE THEMES YOU'LL SEE IN THE NOT
YET IMPLEMENTED ARE THOSE THAT
FELL UNDER THE OVER ARCHING
THEME OF PERHAPS A NEED FOR
ADDITIONAL RESOURCES OR
CONGRESSIONAL ACTION AND/OR
ASSIGNMENT OF LEADS IN ORDER TO
MOVE THE RECOMMENDATIONS FORWARD
AND THAT'S CONSISTENT THROUGH
THE SLIDES WHEN YOU SEE THE DARK
BLUE BUCKET ON NOT IMPLEMENTED.
WHERE WE CAN FOCUS ON THE
IMPLEMENTED FOR THE CONDUCT OF
RESEARCH AND TRIALS AND NOVEL
DRUG DISCOVERY, EVEN AS WE HEARD
IN THE EARLIER PRESENTATIONS WE
HAVE BEEN ABLE TO MAKE PROGRESS
AS IT RELATES TO PERIODS BY
GOVERNMENT FUNDERS AND A
SEPARATE PRIORITIZATION PROCESS
FOR THERAPIES AND/OR CONDITIONS
THAT WOULD NEED TO BE DEVELOPED
IN PREGNANT AND LACTATING WOMEN.
.
AND I CALL OUT THE ADEPT WORK
TAKING PLACE BY NICHD WHERE
THEY'VE MOVED FORWARD NICELY TO
ESTABLISH THE PRIORITIZATION
PROCESS INCLUDING A MEET THE
INAUGURAL MEETING ON RESEARCH
AND PRIORITIZATION OF RESEARCH
ON PREGNANT AND POSTPARTUM AND
LACTATING PEOPLE AND RESEARCH TO
PLAY A ROLE IN RELEVANT DATA TO
MORE BROADLY INCLUDE THERAPEUTIC
PRODUCTS AND PREGNANT AND
LACTATING WOMEN AND ESTABLISHING
FINANCIAL SUPPORT INCENTIVES
THROUGH EITHER ESTABLISHED OR IN
THE DEVELOPMENT OF MULTI-CENTER
INFRASTRUCTURES.
SO THE SECOND FOCUS WILL DISCUSS
IN REGARD TO CLUSTER B
EDUCATION, OUTREACH TRAINING AND
CAREER DEVELOPMENT.
AGAIN, I'D LIKE YOU TO REMEMBER
THE DISCUSSION THE RICH
DISCUSSION FROM EARLIER THAT WAS
HEARD IN COUNCIL AND THINK ABOUT
IT IN TERMS OF THE APPLICATION
AND FOR THE PREGNANT AND
LACTATING POMP.
-- POPULATION.
INTEREST WERE NUMEROUS
ACTIVITIES STARTED EITHER
ONGOING OR NOW IN PROGRESS AND
I'D LIKE TO SPECIFICALLY CALL
OUT 3B THE RECOMMENDATION ON
DEVELOPING MENTORS ON LACTATION
AND THERAPEUTICS FOR CLINICAL
AND BASIC SCIENCE.
I THINK IT RESONATES WITH THE
MESSAGES YOU HEARD THIS MORNING.
AT PRESENT THIS IS A FIELD WIDE
CHALLENGE.
THERE ARE SOME SPECIFIC EFFORTS
DEFINITIVELY NEEDED TO MEET THE
OBSTETRIC AND LACTATION SPACE TO
SEE THIS IMPLEMENTED.
AS IT RELATES TO THE
IMPLEMENTATIONS, TRULY HERE FOR
EDUCATION OUTREACH AND TRAINING
THERE ARE SOME EXISTING
INFRASTRUCTURE FRAMEWORKS IN
PLACE THAT MIGHT BE WILL ABLE TO
BE BETTER LEVERAGED AND/OR MORE
SYSTEMATIC EFFORTS TO OPTIMIZE
THEM INTO A MORE COHESIVE AND
STREAMLINE EFFORT TO MOVE THE
RECOMMENDATIONS FORWARD AND
ULTIMATELY HOPEFULLY SEE THEM
SUCCESSFUL.
IF WE CAN GO TO POLICY AND
REGULATORY AND IT'S A SPACE
WHERE THERE WILL BE A NEED FOR
CONGRESSIONAL ACTION.
THERE'S IN FACT AN ERROR AS IT
RELATES TO 1A.
IT'S LISTED AS PROJECT BUT THE
COMMON RULE WAS UPDATED IN 2019
TO REMOVE PREGNANT WOMEN AS A
VULNERABLE POPULATION AND
THEREFORE WE'LL MAKE SURE THAT'S
UPDATED FOR THE FINAL DECK IN
THE RECORD.
I DO WANT TO HIGHLIGHT WHEN OUR
WORK GROUP WAS GOING THROUGH THE
REVIEW HOWEVER, THE LANGUAGE IS
SPECIFIC IN TERMS OF WHAT IT WAS
CALLING FOR SPECIFIC TO THE
LANGUAGE OF THE COMMON RULE.
THERE'S ALWAYS THE NEED FOR THIS
TO BE IMPLEMENTED ON AN
INSTITUTIONAL LEVEL OR LEVEL
IRBs AND WHILE WE'RE NOTING 1A
IS IMPLEMENTED WE ACKNOWLEDGE
THERE WILL BE OTHER ACTIVITIES
AROUND THE RECOMMENDATION WHICH
MAY NOT HAVE BEEN EXPLICITLY
CALLED FOR BUT NEED TO CONTINUE
TO MOVE FORWARD.
I WILL SAY THERE'S QUITE A BIT
OF WORK THAT'S BEEN DONE TO
BEGIN UNDERSTANDING THE
LIABILITY MITIGATION STRATEGY
THAT WILL NEED TO BE BETTER
ELUCIDATED FOR RESEARCH TO
ENGAGE IN THE PREGNANT AND
LACTATING POPULATIONS HOWEVER,
BECAUSE OF HOW THE
RECOMMENDATIONS HAVE BEEN WORDED
IN THE PRGLAC TASK FORCE,
IMPLEMENTATION PLAN THERE ARE
SOME SPECIFIC ACTIONS THAT WOULD
NIGHT -- NEED TO SEE
IMPLEMENTION -- IMPLEMENTATIONS
TO SEE 7A MOVE FORWARD.
AND MOVING TO CLUSTER D, IT WAS
IN RELATION TO REGISTRIES AND
REAL WORLD DATA.
FOR PURPOSES OF COUNCIL
PRESENTATION AND BECAUSE OF THE
FIRST OVER ARCHING THEME WE
REFERENCED WE PROVIDED THE
CURRENT STATUS AS IT RELATES TO
PREGNANCY AND A SEPARATE SLIDE
FROM LACTATION.
I THINK YOU'LL BEGIN TO SEE WHY
AS WE WALK THROUGH WHAT IS
CURRENTLY IN PROGRESS.
WHAT'S IN PROGRESS IS NUMEROUS
ACTIVITIES RELATED TO DATA
SPECIFIC TO THE PREGNANT
POPULATION OR LINKED FETAL
OUTCOME OR NEONATAL OUTCOME OR
DEVELOPMENT OUTCOME OF AN
INFANT.
THERE'S BEEN NUMEROUS ACTIVITIES
THAT HAVE MOVED FORWARD THAT ARE
IN RESPONSE TO THE
RECOMMENDATION AND SUB
RECOMMENDATIONS FOR THE PREGNANT
POPULATIONS AS IT RELATES TO
REGISTRIES IN REAL WORLD DATA.
WHEN YOU SEE IT'S STILL AS YET
MOVED FORWARD IN THE
NON-IMPLEMENTED SECTION FOR
PREGNANCY IS USER FRIENDLY
WEBSITES AND FACILITATING
TRANSPARENCY OF INFORMATION IN
REGISTRIES AND THE MORE
CHALLENGING PIECE WHICH IS
DEVELOPING AND PRIORITIZING THE
USE OF DISEASE AND CONDITION
FOCUSSED REGISTRIES OPPOSED TO
PRODUCT SPECIFIC REGISTRIES.
THERE'S A MORE ROBUST ABILITY TO
COLLECT INFORMATION IN A MORE
TIMELY FASHION.
THE WORK GROUP HIGHLIGHTED
DIFFERENT REGISTRIES.
THAT'S NOT THE ISSUE.
IT'S A PIECE THAT IS MISSING IS
A COHESIVENESS AND USER
FRIENDLINESS AND THE REGISTRIES
IN EXISTENCE TO BE USED FOR
MULTIPLE PURPOSES AND FOR
MULTIPLE STAKEHOLDERS.
SO GO TO THE NEXT SLIDE AND THIS
IS THE LACTATION SIDE AND THERE
IS QUITE A SIZABLE DIFFERENCE IN
TERMS OF WHAT WE SEEN FOR
IMPLEMENTATION AS IT RELATES TO
THE LACTATION RESEARCH
COMPONENT.
WHILE THERE'S BEEN GREAT
PROGRESS MADE FOR PREGNANCY MOST
PIECES AS IT RELATES TO HEALTH
RECORDS SYSTEMS THE ABILITY TO
USE LARGE STUDY AND DATABASES
AND USES OF NOVEL DATA METHODS
FOR DATA ANALYTICS AND REQUIRING
COMMON DATA ELEMENTS HAVEN'T
PROCEEDED FORWARD AS EFFICIENTLY
AS PREGNANCY.
THIS HAS BEEN A RAPID REVIEW OF
AN INTENSIVE AMOUNT OF WORK DONE
BY THE WORK GROUP.
WE'RE FULLY COGNIZANT OF THAT.
THERE'S NUMEROUS
SUBRECOMMENDATIONS WHICH IS WHY
THE REPORT CONTINUES TO BE IN
PROGRESS.
WHAT I WOULD LIKE TO REMIND
COUNCIL IS THESE KEY THEMES THAT
WE PRESENTED UP FRONT AT THE
START OF THE FINDINGS ARE
ACTUALLY VERY IMPORTANT TO
UNDERSTANDING HOW WE CAN BEST
SUCCEED IN THE SPACE.
SO WE'RE HOPING TO UTILIZE THOSE
THINGS TO FULLY SEE THE TASK
FORCE RECOMMENDATION ELEMENTS
AND THE REPORT WILL BE FINALIZED
IN JUNE.
THE INTENT IS TO PUBLISH AND
DISSEMINATE BY END OF JULY AND
REMEMBER WITH ALL THIS SAID
THERE'S NUMEROUS FEDERAL
AGENCIES THAT HAVE DIFFERENT
IMPLEMENTATION ACTIVITIES IN
DIFFERENT STAGES OF
IMPLEMENTATION AND THERE IS A
NED FOR US TO CONTINUE TO
REMEMBER THAT WE SHOULD ALWAYS
TOUCH BACK AND ASSESS AND MAKE
SURE WE'RE CONTINUING TO SEE THE
PROGRESS THAT'S ALREADY BEGUN TO
DATE.
SO WITH THAT, I WOULD LIKE TO
THANK THE EXPERTS IN OUR WORK
GROUP WHO TOOK ON QUITE A
SIZABLE TANK.
-- TASK.
SUE AND I HAVE BENEFITTED FROM
THEIR INPUT AND THOUGHTFUL
CONSIDERATION AND JUST WHAT IT
WENT TO DETERMINE WHAT THE STAT
WAS AND IN THE CONTEXT OF THE
EXPLICIT LANGUAGE IN THE
RECOMMENDATIONS THAT WERE
DRAFTED BY THE PRGLAC TASK
FORCE.
IN DOING SO IN SUCH A RAPID TIME
FRAME.
THEN I WOULD ALSO LIKE TO ECHO
THE WORDS REFERENCED IN REGARDS
TO NATASHA, YOUR EXPERTISE AND
ABILITY TO KEEP US ON TASK ARE
JUST INCREDIBLE.
I WOULD ALSO LIKE TO THANK THE
NICHD IS VERY LUCKY TO HAVE THE
EXPERTISE AS IT RELATES TO
PUBLIC POLICY AND ETHICS.
WE COULD NOT HAVE MADE THE
REPORT WITHOUT THEIR EXPERT
GUIDANCE AND I'LL STOP THERE AND
WE'LL BE HAPPY TO TAKE WHATEVER
QUESTIONS YOU MIGHT HAVE.
>> WE'RE OPEN FOR QUESTIONS.
I READ THE DRAFT REPORT AND IT'S
OUTSTANDING.
YOU SAID THINGS ARE IN PROGRESS
BUT THERE'S BEEN OBJECTIVES
COMPLETED TO.
OF THE 15 I ONLY REMEMBER ONE
THAT DIDN'T HAVE A WHOLE LOT
GOING ON YET BUT THE REST OF
THEM EITHER HAD BEEN COMPLETED
OR HAD SUBSTANTIAL PARTS OF THE
RECOMMENDATION AND PROGRESS.
AND SOME OF THE THINGS WERE
BEYOND OUR CONTROL SO THAT'S
UNDERSTANDABLE.
I WANT TO CONGRATULATE YOU AS
WELL AS ACKNOWLEDGE THE
EXCELLENT WORK FROM OUR OFFICE
OF LEGISLATION, PUBLIC POLICY
AND ETHICS AS YOU SAID TO GUIDE
YOU THROUGH THIS BUT IT'S REALLY
QUITE REMARKABLE AND IT'S BEEN A
PRIVILEGE TO SEE HOW IT HAS
EVOLVED FROM 2018 TO THE PRESENT
TIME.
IT'S GOING TO ALREADY CHANGE IN
PRACTICE BUT IT'S GOING TO BE
HUGELY IMPACTFUL.
>> I'D LIKE TO ADD YOU'RE 100%
CORRECT ABOUT THESE
RECOMMENDATIONS.
FOR THOSE WHO READ THE TASK
FORCE IMPLEMENTATION PLAN
REMEMBER IT'S A SIZABLE DOCUMENT
WITH SUB RECOMMENDATIONS AND SUB
YOU, SUB, RECOMMENDATIONS.
TO HIT THE RECOMMENDED THE TASK
FORCE SET US UP FOR A BIG
CHALLENGE.
I THINK THERE'S MULTIPLE FEDERAL
AGENCIES TO BE CONGRATULATED FOR
THE PROGRESS TO DATE AND THINK
WHEN YOU READ THROUGH THE MEMO
YOU'LL UNDERSTAND IT MORE
CLEARLY THERE ARE SUB PARTS WITH
NICE PROGRESS AND SOME IN
PROGRESS AND WE HAVEN'T HAD TIME
TO BE FULLY IMPLEMENTED AND
OTHERS REQUIRE ADDITIONAL
FUNDING, PERHAPS CONGRESSIONAL
ACTION TO BE IMPLEMENTED.
>> THERE ARE DOWN STREAM EFFECTS
NOT DIRECTLY CAPTURED BUT THE
RECENT NASEM REPORT ON SOME
LIABILITY CHALLENGES.
YOU WERE HELPING EDUCATE ME FROM
PHARMA AS TO WHAT THE CHALLENGES
ARE WHEN APPROVING DRUGS FOR
LACTATING PEOPLE AND THE AND A
HALF REPORT ARE UNFORTUNATELY
DIDN'T MENTION PRGLAC BUT SHOULD
HAVE, IT WAS STILL VERY
IMPORTANT FOR ACCOMPLISHING THE
OVER ALL GOAL OF INDICATING THAT
IN MANY SITUATIONS IT'S
PERFECTLY SAFE TO GIVE A
PREGNANT PERSON, IN FACT IT'S
BETTER TO GIVE A PREGNANT OR
LACTATING PERSON MEDICATION SHE
NEEDS FOR HER OWN HEALTH RATHER
THAN THE DEFAULT WHICH IS TAKE
NOTHING DURING THE PREGNANCY.
THERE'S A WIRED SPHERE OF
INFLUENCE I WOULD SAY.
SO QUESTIONS.
>> BEFORE WE GO TO QUESTIONS, TO
YOUR POINT FOR THOSE WHO READ
THE MEMO, YOU'LL SEE THERE WERE
SPECIFIC CALLS OUT FROM THE WORK
GROUP ABOUT THE FACT THAT WE'RE
TALKING ABOUT EDUCATION AND
COMMUNICATION AND OUTREACH IS AS
IMPORTANT TO TALK ABOUT THE
IMPACT OF NOT TAKING NECESSARY
MEDICATIONS.
SUCH AS MUCH AS IT IS ABOUT
TAKING MEDICINES OR THE RISK
THERE MAY BE WITH TAKING
MEDICINES.
I THINK THIS IS AN IMPORTANT
PART YOU'LL SEE IN THE DETAILS
OF THE REPORT.
FOR THE NASEM REPORT, THAT WORK
IS NECESSARY TO INFORM NEXT
STEPS.
SO SOME OF THOSE RECOMMENDATIONS
REQUIRED THE FOUNDATIONAL WORK
IN ORDER TO GET TO THE NEXT
PHASE.
>> GOOD TO SEE YOU CHRISTICHRIS
NICE TO MEET YOU, SUE.
FIRST, CONGRATULATIONS TO NICHD
FOR HAVING THE IMPLEMENTATION
WORKING GROUP.
I'VE SEEN A WHOLE LOT OF TASK
FORCE AND WORKING GROUPS THAT DO
TALKING BUT NOT SO MUCH
IMPLEMENTATION.
SO CONGRATULATIONS AND THANKS
FOR THE WORK.
THE PROCESS QUESTION AND THEN
CONTENT QUESTION.
PROCESS QUESTION IS THIS IS A
DYNAMIC PROCESS.
YOU'VE SHOWN US THE THINGS
ALREADY IN PLACE AND THINGS THAT
WILL BE IN PROGRESS.
SO DOES THIS GROUP CONTINUE ON
UNTIL THERE'S AN END GOAL FOR
IMPLEMENTATION OR DRIVING TRUE
TO IMPLEMENT AS MUCH AS
POSSIBLE.
THAT'S MY PROCESS QUESTION.
>> WE HAVE SATISFIED THE
REQUIREMENTS AS LAID OUT IN THE
LEGISLATION.
WE DO NOT HAVE AUTHORITY BEYOND
THAT TO CONTINUE TO MONITOR THE
PROGRESS MADE ON SOME OF THE
IMPLEMENTATION.
THAT ACTION WOULD NEED TO BE
TAKEN TO CONTINUE THE ACTIVITY.
>> AND SO THEN THAT'S A QUESTION
I HAVE FOR NIH.
IS THERE SOMETHING WE DO TO
CONTINUE TO MOVE IT FORWARD?
OR DO WE END IT AT THIS POINT?
WHAT'S OUR PROCESS FOR
IMPLEMENTATION WORKING GROUPS?
>> THIS IS SOMETHING WE HAVE
BEEN THINKING ABOUT AND I THINK
AS SOON MENTIONED WHEN THIS
REPORT COMES OUT THAT WILL
FULFILL THE CONGRESSIONAL
REQUIREMENT OF TRACKING.
I THINK WHERE WE THOUGHT ABOUT
IS HOW AND WHEN THIS SHOULD
CONTINUE.
I THINK WE ALL FELT WE HAVE
ASSESSED WHERE THE
RECOMMENDATIONS ARE AND
CONTINUING IN THE FALL THERE
WILL LIKELY NOT BE CHANGES BUT
WE HAVE THOUGHT ABOUT PERHAPS A
YEAR OR TWO YEARS AFTER THAT IT
MIGHT BE USEFUL TO CONTINUE OR
TO CREATE ANOTHER WORKING GROUP
TO DO A SIMILAR ASSESSMENT TO
SEE IF THERE HAVE BEEN CHANGES
BUT WE'RE THINKING LONGER TERM
ABOUT WHEN TO PERHAPS DO A
SECOND ASSESSMENT.
>> I'M GLAD BECAUSE YOU CAN SEE
MOVEMENT IN THE PROCESS AND
SOMETIMES THEY CAN FALL THROUGH
THE CRACKS.
>> MY QUICK CONTENT QUESTION IS
WHEN YOU SAY MEDICATIONS, WERE
SUPPLEMENTS INCLUDED?
A LOT OF PREGNANT AND LACTATING
WOMEN TAKE SO MANY SUPPLEMENTS.
WAS IT ONLY U.S.-APPROVED
MEDICATIONS?
>> THERE WAS NOT THE QUESTION IN
THE PRGLAC AS TO WHAT THE FOCUS
AREAS SHOULD BE.
THERE WERE PERFORM THERAPEUTICS
AND IT WOULD BE APPROPRIATE FOR
US TO WHAT THE PRIMARY INTENTION
WAS UNDER THE ACT WHEREIN IT WAS
FOCUSSED ON THOSE THERAPEUTICS
AND REGULATED THROUGH THE FOOD
AND DRUG ADMINISTRATION.
>> THE OTHER THING TO SAY AND
THANK YOU, CHRISTINA, GREAT
RESPONSE.
WE HAVE BEEN WORKING AT NIH
THERE'S THE OFFICE OF DIETARY S
AND SO THEY WORK TO COORDINATE
CO-FUND DRIVE AGENDAS AROUND
IMPLEMENT -- SUPPLEMENTS AND
THEIR USE AND THEY TALKED ABOUT
THE IMPROVE INITIATIVE AND
TALKING ABOUT DIETARY
SUPPLEMENTS AS IT RELATES TO
MATERNAL HEALTH.
MORE TO COME BUT IT'S A PARTNER
SIMILAR TO OBSSR.
>> I'M CHIEF OF THE OBSTETRIC
AND PHARMACOLOGY BRANCH.
THE REQUEST FOR INFORMATION
INCLUDED VACCINES WITH DRUGS.
WE'RE WORKING THROUGH HOW TO
PROCESS THAT AND HANDLE IT.
WE HAVE BEEN WORKING WITH THE
OFFICE OF DIETARY SUPPLEMENTS ON
A PERINATAL PHARMACOLOGY
PROJECT.
THAT WILL BE INVOLVED IN LOOKING
AT THE RESPONSE TO THE RFI.
GREAT QUESTION.
>> I WANT TO ACKNOWLEDGE AND
THANK PROGRAM STAFF INVOLVED IN
THE PROCESS AND AS IMPLIED THE
FOLLOW-UP ACTIVITIES A LOT OF
THAT WILL BE SHEPHERDED BY THE
PROGRAM STAFF AND CALLING OUT
THE OBSTETRIC AND PHARMACOLOGY
BARRAGE AND THEY'VE WORKED WELL
TOGETHER AND WITH LAURA'S
OFFICE.
>> I HAVE A QUESTION WHETHER THE
CLINICAL TRIAL WILL APPLY TO
THEM WHAT'S THE DRIVER FOR THE
CHANGE?
WAS IT BECAUSE OF THE
RESEARCHERS PROFESSIONAL
ORGANIZATIONS ON THE WOMEN WANT
THIS?
I LIKE THE PIECE OF WORK JUST
WONDERING AND FOR THE
IMPLEMENTATION HOW THE WOMEN GOT
INVOLVED.
>> I'LL START.
I THINK SUE SPOKE ABOUT IT AT
THE BACKGROUND.
FOR DECADES WE'VE BEEN
PRACTICING MEDICINE AND
UTILIZING EXPERIMENTS FOR EVERY
NEW PREGNANT OR LACTATING
PATIENT WHO NEEDS TO TAKE A
THERAPEUTIC AND THERE'S BEEN
LIMITED STUDIES TO EITHER A,
INCLUDE PREGNANT PATIENTS OR
STUDY FUNDING FOR THERE TO BE
TRIALS IN PREGNANT WOMEN OR
LACTATING WOMEN.
SO AS THE A CLEAR AND DIRE NEED.
THIS TASK FORCE WAS IMPLEMENTED
PRIOR TO THE COVID PANDEMIC.
THOUGH WE MAKE NO REFERENCE TO
IT IN OUR DOCUMENT ELUCIDATED
THOSE WHO NEVER THOUGHT ABOUT
WHAT HAPPENED WHEN THEY'RE MOM
WAS PREGNANT WITH THEM AND
WHETHER THEY NEEDED SOMETHING
NOT STUDIED AND WHAT THAT MEANS.
THERE'S A HUGE VOID AND CLEAR
NEED.
6:
THERE'S A PATH FORWARD THAT'S
PRAGMATIC TO HAVE INFORMATION
VALUABLE TO INFORM NOT ONLY
THERAPEUTICS DEVELOPMENT BUT
CLINICAL PRACTICE AND ULTIMATELY
ENSURE THE SAFETY OF THE
PATIENTS.
I THINK THERE'S MANY PIECES TO
IT.
SUE, PLEASE ADD ON AND OTHER
COLLEAGUES FROM NICHD FEEL FREE
TO ADD UPON.
>> IF YOU LOOK AT THE ORIGINAL
LEGISLATION WE DONT HAVE A LOT
OF RESEARCH GROUPS PART OF A LOB
THREEI II II IING -- LOBBYING F
EFFORT.
IT'S FROM A GRASSROOTS EFFORT
CDC HAS TALKED ABOUT THE BEST
WAY TO ENGAGE INDIVIDUALS THEY
HAVE TO BE A CONTINUED PART
MOVING FORWARD.
>> I HAVE A COMMENT.
I WANTED TO THANK YOU SO MUCH
FOR THE WORK.
FOR THOSE DOING RESEARCH IN
OBSTETRICS ON PREGNANT PATIENTS
FOR DECADES WE APPLAUD YOU AND
THOSE PRACTICIE IING OBSTETRICI
THANK YOU BECAUSE IT'S
INFORMATION WE NEED.
I HAVE AN ADDITIONAL QUESTION.
THERE'S A QUESTION OF STUDYING
THESE AND LOOKING AT THE R25,
WOULD THAT BE SOMETHING TO TRAIN
FOLKS FOR OBSTETRIC ADJACENT TO
LEARN HOW TO DO THIS PROPERLY
AND MAYBE NOT GET A Ph.D. BUT
MAYBE A MASTER'S DEGREE TO
CONTINUE TO INCORPORATE THESE
PEOPLE IN OUR RESEARCH.
>> AND AARON MAY WANT TO COMMENT
BUT BOTH BRANCHES THINK ABOUT
IT.
ONE THING THAT AARON BRANCH HAS
DONE THE OBSTETRIC AND PEDIATRIC
PHARMACOLOGY WERE ISOLATE AND
SILOED AND BROUGHT THEM TOGETHER
RECOGNIZING THE PHARMACOLOGIC
SCIENCE UNDER PINS BOTH.
THERE'S A GREATER INTERACTION
WITH THAT GROUP AND AS YOU HEARD
EARLIER FROM LESLY SAMEDY BATES
THEY'RE INCLUDING BOTH AND AARON
DO YOU HAVE MORE TO ADD?
>> THAT WAS A GOOD SUMMARY.
WITH HAVE BEEN WORKING TO
ENCOURAGE FOLKS TO COME IN WITH
MATERNAL PHARMACOLOGY T32
APPLICATIONS AS WELL AS THINKING
ABOUT WAYS AS THE R25.
YOU AND GETTING PEOPLE TRAINED
ENOUGH TO BE ABLE TO UNDERSTAND
THE LANGUAGE IS CRITICAL.
AND THERE'S A TRAINING MECHANISM
COOPERATIVE AGREEMENT A LOT OF
INSTITUTES ARE STARTING TO USE
CREATIVELY.
WE'VE TALKED WITH LESLY ON
DIFFERENT WAYS TO DO THAT AND
ECHO WHAT CHRISTINA AND SUE SAID
THERE'S NOT A LOT OF RESOURCES
TO DO THIS AT THIS POINT.
THAT HAS BEEN ONE OF THE MAJOR
CHALLENGES.
WE HAVE BEEN ABLE TO MOVE MANY
THINGS FORWARD THANKFUL TO DIANA
FOR ALLOCATED RESOURCES TO MOVE
FORWARD WITH THE THINGS WE'VE
BEEN ABLE TO GET PROGRESS.
>> TO TAG ON TO THAT, A LOT OF
THE MEDICATIONS THAT ARE
PRESCRIBED TO WOMEN ARE RELATED
TO OTHER HEALTH ISSUES, MENTAL
HEALTH, CARDIOVASCULAR HEALTH.
HOW MUCH DO YOU INTEGRATE THIS
WITH THE INSTITUTES THAT COVERED
THAT RESEARCH?
>> WE RECENTLY CREATED UNDER THE
UMBRELLA OF THE MATERNAL AND
CHILD PHARMACOLOGY SUB GROUP AND
STARTING TO BUILD A COALITION OF
INDIVIDUALS AND THE OFFICE OF
DIETARY SUPPLEMENTS ARE
REPRESENTED THIS.
FOR THE MEETING WE'LL HOLD IN
JULY WE HAVE MODERATORS FROM
EACH OF THE RELEVANT INSTITUTES
THAT COVER THAT DISEASE AREA.
WE ARE VERY MUCH DRAWING A
DISTINCTION FOR TECHNICAL
REASONS FOR PREGNANCY CONDITIONS
OF LACTATION VERSUS THOSE
CO-OCCURRING DURING PREGNANCY
AND LACTATION.
MOVING FORWARD WILL HAVE TO BE A
TRANS-NIH EFFORT AND EXCITING TO
SEE SO MANY THINGS IN WOMEN'S
HEALTH NOW.
>> FOR THOSE WHO READ THROUGH
THE MEMO IT'S RELATED TO CLUSTER
B IN PARTICULAR ON OUTREACH
TRAINING AND CAREER DEVELOPMENT.
THE WORK GROUP HAD CAREFUL
PLACED COMMENTS SPEAKING TO THAT
POINT.
THIS IS IN FACT A NEED THAT GOES
BEYOND OBSTETRICS AND LACTATION
RESEARCH.
IT GOES INTO EVERY THERAPEUTIC
WHERE WE'RE DEVELOPING MEDICINES
WHERE YOU COULD HAVE AN
UNDERLYING CONDITION AND BECOME
PREGNANT.
SO AS THE A DEFINITIVE NEED FOR
THIS TO BE LOOKED AT FROM ACROSS
INSTITUTES.
>> I WANTED TO FOLLOW UP ON THE
PREVIOUS QUESTION.
THERE ARE ALSO CONDITIONS WHERE
A WOMAN HAS AN AUTO IMMUNE
DISEASE AND HAS TO GO OFF
MEDICATION FOR WHATEVER REASON
WHEN SHE BECOMES PREGNANT AND
THE SYMPTOMS GO AWAY DUE TO
HORMONAL OR WE DON'T KNOW WHY
SUCH AS RHEUMATOID ARTHRITIS AND
AFTER PREGNANCY COMES BACK WITH
A VENGEANCE.
WHETHER THEY CONTINUED ON
MEDICATION WHETHER LOW DOSE TO
REDUCE THE SYMPTOMS THAT COME
BACK SEVERELY AFTER PREGNANCY IS
ANOTHER WINDOW TO UNDERSTAND HOW
MEDICATIONS MAY HAVE BEEN BETTER
OFF CONTINUED DURING PREGNANCY.
>> WE NEED TO UNDERSTAND THE
RISK COMPONENT FOR DECADES WE
STUDIED THE RISK COMPONENT.
WE HAVEN'T STUDIED THE METH CAL
OR PHARMACOLOGY COMPONENT AND
RELEVANT DOSING COMMENT AND WE
NEED TO GO BEYOND JUST SAFETY
AND REALLY LOOK TO THE
UNDERSTANDING AS IT RELATES
ACROSS TRIMESTERS AND RELATES TO
PHARMACOLOGY AND THE EFFECTIVE
DOSE GIVEN DIFFERENT CONDITIONS
AND DIFFERENT PHASES OF
PREGNANCY.
THANK YOU.
GOOD COMMENT.
>> OKAY.
ANY FURTHER DISCUSSION?
IF NOT I'M GOING TO THANK
DOCTORS BUCCI-RECHTWEG AND
ABDEL-RAHMAN AND A GREAT
PRESENTATION AND THE REPORT WILL
BE OUT THIS SUMMER.
FLOU -- NOW WE NEED A MOTION FOR
APPROVAL OF THE WORKING GROUP'S
REPORT.
CAN SOMEONE MOVE.
THANK YOU, CYNTHIA.
>> SECOND.
>> NOW, WE'RE GOING TO VOTE
USING OUR HANDS AND GENEVIEVE
AND CHRISTINA, CAN VOTE
ELECTRONICALLY.
IF YOU APPROVE --
>> DO I NEED TO ABSTAIN?
>> EXCELLENT.
THANK YOU.
>> 13 IN FAVOR, ONE ABSTENTION.
>> THANK YOU VERY MUCH.
WE ALSO WANT TO THANK THE STAFF
INVOLVED IN THE REPORT AS WELL
AS OFFICE OF LEGISLATION, PUBLIC
POLICY AND ETHICS.
NOW WE HAVE ONE MORE WORKING
GROUP THAT'S GOING TO REPORT ON
THEIR DELIBERATIONS.
NOW, REMEMBER THEY ARE A FEW
YEARS BEHIND PRGLAC.
SO THEY'RE IN A YOUNGER PHASE IN
TERMS OF THEIR WORK AND WE'RE
VERY HAPPY TO WELCOME BACK
DR. LUCKY JAIN AND DR. UMA REDDY
A FORMER NICHD STAFF MEMBER.
WE ESTABLISHED THE COUNCIL IN
LATE 2022 IN RESPONSE TO A
U.S. DEPARTMENT OF HEALTH AND
HUMAN SERVICES REQUEST TO LEAD A
CONGRESSIONALLY MANDATED TASK
FORCE TO SOMEONE THE SIGNIFICANT
PROBLEM OF STILLBIRTH IN THE
UNITED STATES.
THE WORKING GROUP PRESENTED
THEIR RECOMMENDATIONS TO YOU
BACK IN JANUARY OF 2023 AND NOW
WE'LL HEAR AN UPDATE FROM THOSE
CO-CHAIRS, DR. LUCKY JAIN AND
DR. UMA REDDY.
LUCKY JAIN IS A NEONATOLOGIST AS
CHIEF AND DEPARTMENT OF
PEDIATRICS CHAIR AT THE
CHILDREN'S HEALTH CARE OF
ATLANTA.
HE'S ALSO THE GEORGE W. BRUMLY
JR. PROFESSOR, CHAIR OF
DEPARTMENT OF PEDIATRICS ATHET
EMORY SCHOOL OF MEDICINE AND
EXECUTIVE DIRECTOR OF THE EMORY
CHILDREN'S PEDIATRIC INSTITUTE
AND SERVED AS A MEMBER OF THE
NICHD ADVISORY COUNCIL AND WE
MISS HIM.
DR. UMA REDDY IS AN OBSTETRICIAN
GYNECOLOGIST AND VICE CHAIR OF
RESEARCH AND PROFESSOR OF
OBSTETRICS AND GYNECOLOGY AT
COLUMBIA UNIVERSITY AND COLUMBIA
UNIVERSITY IRVING MEDICAL
CENTER.
SHE PREVIOUSLY SERVED AS A
MEDICAL OFFICER IN THE
PERINATOLOGY BRANCH AND MISS HER
AS WELL.
THEY'RE GOING TO PRESENT THE
STILLBIRTH UPDATE.
THANK YOU.
>> IT'S A REAL HONOR TO BE BACK
WITH THE NICHD COUNCIL.
I DO MISS YOU ALL AS WELL.
BEFORE I GET IN THE
RECOMMENDATIONS ON BEHALF OF
DR. REDDY AND MYSELF I WANT TO
THANK MS. WILLIAMS AND MS. LONGO
IN PREPARING THE PREVIOUS REPORT
AND THE CURRENT WORK WE HAVE
ACCOMPLISHED I FEEL IN A VERY
EFFICIENT MANNER.
DR. BIANCHI HAS ALREADY
MENTIONED BACK IN 2022, THE
CONGRESSIONAL MANDATE AHLLOWED S
TO ESTABLISH A TASK FORCE.
A MILLION DOLLARS WAS
CONTRIBUTED BY THE CONGRESSIONAL
COMMITTEE TO GET THAT WORKFORCE
STARTED.
.
THAT WORK FOCUSSED LARGELY ON
GETTING THE CDC AND NIH AND
OUTSIDE ORGANIZATIONS TO WORK
TOGETHER TO FOCUS ON FOUR
PRIMARY AREAS.
THE FIRST ONE WAS CURRENT
BARRIERS TO COLLECTING DATA ON
STILLBIRTHS THROUGHOUT THE
UNITED STATES.
SECOND WAS COMMUNITIES AT HIGH
RISK OF STILLBIRTHS AND LOOKING
AT TREATMENT OPPORTUNITIES FOR
MOTHERS FOLLOWING STILLBIRTH AND
FINALLY TO LOOK MORE CLOSELY AT
THE KNOWN RISK FACTORS FOR
STILLBIRTHS.
THE NEXT SLIDE SHOWS WHAT WE DID
IN OUR FIRST REPORT.
THE FIRST REPORT FOCUSSED
LARGELY ON THE AREAS AND THE
REPORT WAS ENTITLED WORKING TO
ADDRESS THE TRAGEDY OF
STILLBIRTHS BUT GIVEN
STILLBIRTHS STILL AFFECT A LARGE
NUMBER OF PREGNANCIES IN THE
UNITED STATES AND WHEN THAT
HAPPENS.
WE HEARD FROM PEOPLE WHO COME
THROUGH THIS HOW DEVASTATING THE
OCCURRENCE IS AND HOW FOR
DECADES LATER THEY CONTINUE TO
LIVE THROUGH THAT HORRIFYING
EXPERIENCE.
THE NEXT FEW SLIDES I'LL
SUMMARIZE FOR YOU WHAT WE
DISCOVERED IN THE FIRST YEAR OF
ENGAGEMENT WITH ALL OF THE
EXTERNAL AGENCIES AND NICHD AND
THE TASK FORCE.
THE FIRST RECOMMENDED TO THE
BARRIERS AROUND COLLECTING DATA
ON STILLBIRTH WAS THAT WE NEEDED
PROCEDURES TO IMPROVE THE
CONSISTENCY AND QUALITY OF DATA
COLLECTION.
WE NEEDED TO STANDARDIZE CASE
DEFINITIONS BUT WE NEEDED TO
TRAIN PEOPLE WHAT INVOLVED IN
DATA COLLECTION FOR THE DEATH
CERTIFICATE BECAUSE THE PROCESS
WAS HAPHAZARD AND NEEDED A WAY
TO UPDATE REPORTS AND OUTREACH
TO LOCALITIES TO LOOK AT
STILLBIRTH DATA REQUIRED
INCLUDING AN AUTOPSY.
FURTHER DEFINING THE
RECOMMENDATIONS WE FELT THE NEED
TO CONDUCT POPULATION-BASED
STILLBIRTH SURVEILLANCE AND
DIVERSE JURISDICTIONS WE NEEDED
TO EXPLORE COLLECTION SYSTEMS
THAT EXIST IN THE CDC SYSTEM.
THAT WE FURTHER NEEDED TO
CONDUCT VALIDATION STUDIES OF
CURRENT DATA SOURCES.
THEY TEND TO BE VERY STATE
CENTRIC AND VERY DESPERATE IN
THE WAY THEY ARE VALIDATED.
WE NEEDED TO LEVERAGE OTHER
SURVEILLANCE DATA FOR STILL
BIRTH RESEARCH AND FINALLY THERE
WAS URGENT NEED TO LINK THE MANY
SOURCES OF DATA THAT ULTIMATELY
ALLOW MEANINGFUL INFORMATION TO
BE GATHERED.
IN ADDITION WE FELT THERE WAS
TRAINING NEEDED TO IMPROVE VERY
LITTLE PATHOLOGY, GENETICS AND
OTHER AREAS TO ADVANCE THE
PRACTICE OF FETAL AUTOPSY GIVEN
FETAL AUTOPSY WAS BEING DONE IN
A RELATIVELY SMALL NUMBER OF
ROOM AUTOPSY OCCURRENCES.
NOW, IN THE NEXT MAIN AREA
IDENTIFYING COMMUNITIES OF
STILLBIRTH WE REALIZED THERE
WERE LARGE DISPARITIES IN
STILLBIRTH OCCURRENCE AND NEEDED
TO ADDRESS RACIAL, ETHNIC, SOCIO
ECONOMIC AND GEOGRAPHIC AND
OTHER DISPARITIES.
WE ALSO RECOGNIZE THE NIH SHOULD
REVIEW STUDIES TO MAKE SURE THAT
THERE IS PROPER REPRESENTATION
OF THE GROUPS BECAUSE WE NEVER
GET TO A CLEAR ANSWER IN A
PROSPECTIVE MANNER.
WE ALSO RECOGNIZE THE NIH NEEDED
TO EXPAND RESEARCH IN
COMMUNITY-BASED AREAS IN
STILLBIRTH BY AT RISK
POPULATIONS AND FINALLY BARRIERS
TO IMPROVE DATA ON STILLBIRTH
NEEDED TO BE REMOVED.
AND THAT INCLUDED REPRESENTATION
OF INDIVIDUALS WITH DIVERSE
ETHNIC AND RACIAL BACKGROUNDS
AND PARTICULARLY GROUPS THAT
EXPERIENCE THESE DISPARITIES.
HAVING PSYCHOLOGICAL IMPACT OF
STILLBIRTH WAS PARTICULARLY
CHALLENGING.
AS WE BEGIN SPEAKING WITH
MOTHERS WHO HAVE GONE THROUGH
THIS EXPERIENCE, WE REALIZED HOW
TRAUMATIZED THEY WERE AND HOW
LITTLE THEY FELT ROOM IN TERMS
OF SUPPORT AS THEY WERE MOVING
THROUGH THE EXPERIENCE.
MY RECOMMENDATION WAS THE NIH,
CDC, HHS SHOULD ALL PARTICIPATE
IN CONDUCTING SYSTEMATIC
RESEARCH TO COLLECT DATA FROM
INDIVIDUALS WHO HAVE LIVED
THROUGH THIS EXPERIENCE.
AND GET TO PSYCHOLOGICAL IMPACT
OF STILL BIRTHS.
WE ALSO THINK IMPLEMENTATION
RESEARCH SHOULD BE DESIGN TO
INFORM EFFORTS ON HOW TO DEVELOP
CULTURALLY SENSITIVE PROGRAMS TO
SUPPORT THESE FAMILIES AFTER
STILLBIRTH.
RESULTS FROM THESE ULTIMATELY
WOULD HELP IMPROVE AND PROVIDE
TRAINING AND HELP INCORPORATE
SUPPORTIVE PRACTICES INTO CARE
OF EFFECTED FAMILIES.
MUCH IS KNOWN IN RISK FACTORS
FOR STILL BIRTHS.
WE FELT MORE BASIC
TRANSLATIONAL, CLINICAL AND
PUBLIC HEALTH RESEARCH
ENGAGEMENT WAS NEEDED TO DEVELOP
A RESEARCH AGENDA WHICH
ULTIMATELY COULD ADVANCE
PREVENTION OF STILL BIRTHS.
THE RESEARCH AGENDA WOULD
INCLUDE EFFORTS TO IDENTIFY TRUE
IMPLICATIONS OF STILLBIRTH
PREVENTION FROM THE NIH HUMAN
PLACENTA PROJECT AND RELATED
RESEARCH THAT'S ALREADY BEEN
DONE.
FURTHER, WE FELT WE NEEDED TO
ESTABLISH BASELINE DATA ON THE
PHYSIOLOGY OF PREGNANCY
INCLUDING IN PARTICULAR
POTENTIAL INDICATORS OF HEALTH
AND DISEASE AND MAY INCLUDE AND
NOT LIMITED TO THE CENTER
DEVELOPMENT AND FUNCTION FETAL
MOVEMENT, FETAL GROWTH,
ETCETERA.
AND FINALLY WHEN WE LOOKED AT
RESEARCH RISK FACTORS WE
REALIZED THAT THE FOCUS ON UNDER
INVESTIGATED AREAS MIGHT
DISCOVER NEW RISK FACTORS WE'RE
NOT AWARE OF RIGHT NOW.
PARTICULARLY IN THE AREA OF
HEALTH DISPARITIES AND
STILLBIRTH.
ULTIMATELY STILLBIRTH HAVING A
REGISTRY WITH GOOD AUTOPSY DATA
WOULD BE HELPFUL IN THAT REGARD
AND ULTIMATELY WE WOULD THEN BE
ABLE TO DEVELOP AND TEST
INDICATORS AND CLINICAL
INTERVENTIONS FOR STILLBIRTH
PREVENTION.
SO A SUMMARY OF THESE
RECOMMENDATIONS ESSENTIALLY IS
PROVIDED IN THIS SLIDE WHICH IS
TO IMPROVE THE QUALITY OF VITAL
STATISTICS AND SURVEILLANCE AND
EPIDEMIOLOGIC INFORMATION AT ALL
LEVELS, LOCAL, STATE AND
NATIONAL LEVELS.
WE NEED TO USE INSIGHT FROM
IMPROVED EPIDEMIOLOGIC DATA TO
CONDUCT ADDITIONAL RESEARCH TO
HELP EXPLAIN AND ADDRESS
DISPARITIES INTO STILLBIRTH.
WE NEED TO CONDUCT
IMPLEMENTATION RESEARCH AND
DEVELOP CULTURALLY SENSITIVE
INTERVENTIONS TO SUPPORT
FAMILIES WHO EXPERIENCE
STILLBIRTH AND FINALLY CREATE
AND SUPPORT A ROBUST RESEARCH
AGENDA FOR KNOWN AND UNKNOWN
RISK FACTORS IN THE PHYSIOLOGIC
MECHANISMS THAT ULTIMATELY LEAD
TO STILL BIRTH AND THAT
ULTIMATELY WE WOULD TRY TO
MODIFY TO PREVENT STILLBIRTHS.
FAST FORWARD TO 2023 DR. BIANCHI
MENTIONED THE CONGRESSIONAL TASK
FORCE HOPEFULLY LIKES OUR WORK
AND THE REPORT AND CAME BACK
WITH ANOTHER ALLOCATION FROM THE
COMMITTEE FROM THE CONGRESSIONAL
COMMITTEE TO THE SECRETARY TO
GIVE US ONE MORE YEAR OF WORK.
I THOUGHT WE WERE DONE BY THEN
BUT THIS EXTENDED THE WORK OF
THE TASK FORCE BY ANOTHER YEAR
ESSENTIALLY.
WE FOCUSSED ON SEVERAL OF THE
AREAS WE ALREADY IDENTIFIED THE
PEOPLE WHO PARTICIPATED IN THE
EARLY PHASE AND THE SECOND AND
THE CONGRESSIONALLY MANDATED
PERFORMANCE ASSEMBLED THROUGH
THE NICHD AND THE MEMBERS ARE
OVER HERE.
YOU CAN BROWSE THROUGH IT LATER
AT YOUR CONVENIENCE, SEVERAL
COUNCIL MEMBERS ARE ALSO
INCLUDED OVER HERE.
AND THE GROUP FOCUSSED ON
STILLBIRTH PREVENTION AND
STRATEGIES AND THIS WAS LED BY
DR. BOB SILVER AND DR. ALISON
CAHILL AND THE THIRD GROUP
FOCUSSED ON ENHANCING RESOURCES
FOR FAMILIES IMPACTED BY
STILLBIRTH AND THIS GROUP WAS
CO-LED BY DR. JILL WEBBER AND
DR. KAREN GIBBONS.
THE GENERAL RECOMMENDATIONS FROM
THE GROUPS ARE LISTED IN THE
NEXT COUPLE SLIDES.
I WON'T GO THROUGH THE DEPTH OF
THE SLIDES BECAUSE THAT'S WHERE
DR. UMA REDDY IS GOING TO COVER
BUT TO SHOW YOU -- GIVE YOU THE
OVER ALL ESSENCE OF WHERE WE'RE
HEADING WITH THIS THE COMPELLING
NEED TO STANDARDIZE DATA
REPORTING AND COLLECTION TO
PROMOTE MORE ACCURATE AND
CONSISTENT SURVEILLANCE OF STILL
BIRTHS THAT THERE IS NEED FOR
SUPPORT FOR POPULATION-BASED
SERVICE SUCH AS EXPANDING THE
CDC PRAMS NETWORK AND THE SOARS
SURVEY TO CAPTURE THOSE
EXPERIENCING THE HIGHEST
STILLBIRTH BURDEN.
WE NEED TO EXPLORE THE ROLE OF
ARTIFICIAL INTELLIGENCE AND
MACHINE LEARNING AND IMPROVING
MEDICINE IN CARE DELIVERY AND
IMPROVING RISK PREDICTION AND
SINCE THEY HELD INFORMATION CAN
BE SAFEGUARDED IN THE PROCESS.
WE NEED TO EDUCATION RISK
FACTORS OR OTHER INTERVENTIONS
THAT NEED TO BE LOOKED INTO
CAREFULLY.
CREATE STANDARDIZED TRAINING
WITH RESOURCES AND COMPLETE
STILL BIRTH WORK UP TO BE
ACCOMPLISHED.
WE WANTED TO MOVE AWAY FROM F
FRAGMENTATION OF HOW THIS IS
DONE AND HAVE PLACENTAL
PATHOLOGY EVEN IF DONE IN
SMALLER COHORTS AND TO PROVIDE
MORE WHOLESOME INFORMATION TO
GUIDE INTERVENTION STRATEGIES.
WE NEED TO CREATE INFRASTRUCTURE
FOR PERINATAL AUDITS TO ENABLE
ANALYSIS AND DISCUSSION OF
STILLBIRTHS AND FURTHER
IDENTIFICATION OF RISK FACTORS.
HOW INTERPERSONAL RACISM
CONTRIBUTE TO THE HORRIBLE INEYE
QUALITIES IN STILLBIRTH RATES.
AND.
IMPROVE ACCESS TO HEALTH CARE
OPPORTUNITIES, IMPROVE QUALITY
OF CARE AFTER STILLBIRTH WHEN IT
IS NOT PREVENTIBLE AND IMPROVE
BEREAVEMENT CARE AS WELL.
AND THERE'S BEEN A LOT THAT
WE'VE ACCOMPLISH AND DISCUSS
DETAILS OF THE RECOMMENDATIONS.
I JUST WANTED TO ONE MORE TIME
THANK DR. BIAGE --
DRDR. BIANCHI
AND THEIR SUPPORT.
>> FIRST TO THE PREVENTION AND
STRATEGIES SUB GROUP.
AND LACK OF AUTOPSY PLEASED TO
HISTOLOGY INFORMATION TO IMPROVE
CAUSES OF STILLBIRTH AROUND
POTENTIAL AVENUES OF PREVENTION.
GENETIC TESTING IS OFTEN NOT
DONE OF THE COST AND LOGISTICAL
CHALLENGES AND THE PROCESS OF
CAPTURING INFORMATION ON THE
CAUSES OF STILLBIRTH AND
ANALYZING THE QUALITY OF CARE
RESOURCED IN AN ANTIDISCIPLINARY
ACTION TO GUIDE ACTION TO
PREVENT DEATHS IN THE FUTURE IS
NOT ROUTINELY PERFORMED.
SO RECOMMENDATIONS FROM THE
GROUP.
CONSIDER RESEARCH ON TIMING OF
DELIVERY TO DEVELOP PERSONALIZED
RECOMMENDATIONS ON THE OPTIMAL
TIME BASED ON RISK FACTORS.
CURRENTLY INDUCTION OF DELIVERY
MAY BE DELIVERED AT 39 WEEKS PER
STUDY RESULTS WHICH SHOWED LOW
RISK PATIENTS INDUCTION AT 39
WEEKS OF GESTATION WITH LOWER
RATES OF HYPERTENSIVE DISORDERS
AND PREGNANCY AND NO MATERNAL OR
NEONATAL HARMS BEYOND GOING
THOSE WEEKS AND WITH THE SOCIAL
DETERMINATES OF HEALTH AND
POPULATION-BASED STILLBIRTH
SURVEILLANCE AND JURISDICTIONS
WITH HIGH BIRTH RATES AND
PROVIDING ACCESS TO PRENATAL
CARE AND POSTPARTUM CARE.
RESEARCH IS NEEDED TO DEVELOP
STILLBIRTH PREVENTION BUNDLES
WITH PUBLIC HEALTH MEASURES SUCH
AS ADVICE TO CEASE TOBACCO USE,
HELPING PEOPLE ACHIEVE A BETTER
BODY MASS INDEX AND MANAGE
DIABETES AND OBESITY AND OTHERS
AND LOOKING AT MEDICAL REPORTS
CONSIDER A STILLBIRTH REGISTRY
AND COLLECTING BIO SPECIMENS AND
LOW-DOSE ASPIRIN ACCORDING TO
THE PREVENTIVE TASK FORCE
GUIDELINES.
NEXT WE'LL TURN TO THE IMPROVING
DATA COLLECTION SUB GROUP SLIDE
AND THEIR FINDINGS.
SURVEILLANCE AND DEFINITIONS AND
GESTATIONAL AGE VARY BY STATE.
THEY'RE NOT CURRENTLY
STANDARDIZED.
THEREFORE DATA COLLECTION IS
INCONSISTENT.
CLINICAL DATA COLLECTED FROM
MULTIPLE SOURCES, ELECTRONIC
ELECTRONIC HEALTH RECORDS,
STUDIES, GENETIC TESTING AND
PREGNANCY EXPERIENCE AND PATIENT
HISTORY ARE NOT INTEGRATED OR
LINKED SO ALL INFORMATION FOR
RESEARCH AND STILLBIRTH
PREVENTION.
THERE'S A LACK OF UNIFORM
TRAINING OF INDIVIDUALS
COMPLETING FETAL DEATH S
CERTIFICATES AND THEY'RE
CURRENTLY REQUIRED DAYS BEFORE
THE RESULTS OF THE WORKUP ARE
AVAILABLE.
THEY'RE IMPORTANT BECAUSE THEY
MAY BETTER IDENTIFY THE CAUSE OF
DEATH.
FULL WORKUP DEATH RESULTS ARE
OFTEN NOT INCORPORATED INTO THE
DEATH CERTIFICATE AND A LEGAL
ELEMENT IS NEEDED AND SUBSEQUENT
TESTING MAY NOT BE INTEGRATED
INCLUDING NOT IN THE FINAL CAUSE
OF DEATH.
RECOMMENDATIONS INCLUDE
COLLECTING, TRANSFORMING AND
INTEGRATING AN MAINTAINING
HEALTH RECORDS IN FUTURE USE FOR
ARTIFICIAL INTELLIGENCE AND
MACHINE LEARNING TO CREATE A
MATERNAL HEALTH DATA ECO SYSTEM
SERVING AS A MAJOR RESOURCE ON
STILLBIRTH AND OTHER ADVERSE
PREGNANCY OUTCOMES AND DATA
DELIVERY AND WORKUP COMPLETION
SPECIFICALLY FOCUSSING ON DATA
STANDARDIZATION AND QUALITY
IMPROVEMENT ON REPORTING AND
CASE CONTROL STUDY BY LEVERAGING
ARTIFICIAL INTELLIGENCE TO
COLLECT DATA FOR COLLECTION
MEASURES AND MATERNAL EXPERIENCE
EVALUATION AND ASCERTAINMENT
SURVEILLANCE AND HEDGE
STILLBIRTH EVALUATION TO
TELEHEALTH AND CENTERS OF
EXCELLENCE AND FETAL AND INFANT
MORTALITY REVIEW.
IMPROVE AND DEVELOP QUALITY
INDICATORS FOR EVALUATION,
COUNSELING AND BEREAVEMENT AND
FOLLOW-UP AND CONDUCT AUDITS TO
IMPROVE THE QUALITY OF DATA
COLLECTION.
FOR THE RECOMMENDATIONS ON
EDUCATION WERE THE FOLLOWING
YOU, STATE FIELD REPRESENTATIVES
SHOULD PROVIDE DATA AND DEVELOP
TOOLS DEVELOPED AND PERSONNEL
EDUCATED ON USING A CHART
DEVELOPED TO FILL OUT THE FETAL
DEATH CERTIFICATE AND PERSONNEL
TO YOUED RECEIVE TRAINING FOR
ACCURACY AND COMPLETENESS SO
RESULTS ARE ADDED AS NEEDED.
LAST, ENHANCING RESOURCES FOR
FAMILIES IMPACTED BY STILLBIRTH
AND THEIR FINDINGS.
THERE'S NOT ALWAYS APPROPRIATE
CARE AT THE TIME OF BEREAVEMENT
VITAL TO MEET THE NEEDS OF
FAMILIES.
HEALTH CARE PROFESSIONALS AMONG
OTHER THINGS LIKE CULTURAL
SENSITIVITY AND HOW TO SPEAK
WITH BEREAVED PARENTS AND
THERE'S INADEQUATE RESOURCES FOR
THOSE WHO EXPERIENCE STILLBIRTH
ESPECIALLY SMALLER HOSPITALS
WITH LIMITED RESOURCES AND
PROFESSIONALS ARE INADEQUATELY
TRAINED REGARDING STILLBIRTH.
AT THE TIME OF DIAGNOSIS
CAREGIVERS SHOULD DISPLAY
EMPATHY AND REFER TO THE
STILLBIRTH INFANT AS A BABY AND
USE THE NAME IF ONE HAS BEEN
GIVEN.
PROVIDE A ROAD MAP OF THE
HOSPITALIZATION INCLUDING ITEMS
THEY MIGHT NEED OR WANT IN THE
HOSPITAL AND WHAT TO EXPECT
AROUND THE DELIVERY AND WHAT THE
BABY MIGHT LOOK LIKE AT BIRTH,
OPTIONS FOR PAIN MANAGEMENT,
INFORMATION ON A CODDLE COT AND
OPTIONS FOR MEMENTOS OR
PHOTOGRAPHY.
HAVING A BEREAVEMENT HEALTH CARE
PROFESSIONAL A DOULA OR SOCIAL
WORKER TO SUPPORT FAMILIES
DURING THE HOSPITAL STAY.
AFTER DELIVERY THE FOLLOWING
STEPS ARE RECOMMENDED TO THOSE
PROVIDING CARE TO THE PARENT.
PUT THE PATIENT IN RECOVERY AWAY
FROM OTHER PREGNANT PEOPLE AND
SOUNDS OF LIVE BORN INFANTS.
PLACE A MARKER ON THE DOOR SO
THE HEALTH CARE WORKERS ARE
AWARE OF THE LOSS OF THE ARE
INFANT AND SUPPORT THE PARENTS'
DECISION TO ENGAGE IN ACTIVITIES
AND INCLUDING PHOTOS, VIDEOS OR
OTHER MOMENTOS OF THE STILLBIRTH
CHILD IS IMPORTANT.
FOR THE POSTPARTUM WORKUP CREATE
RESOURCES TO HELP PARENTS BETTER
UNDERSTAND HOW THE INFORMATION
COLLECTED FROM TESTS AND
EXAMINES CAN HELP DERM DETERMINE
THE CAUSE OF THE DEATH AND
IDENTIFY IMMEDIATE HEALTH
CONCERNS FOR THE BIRTHING
PARENT, MANAGEMENT FOR
SUBSEQUENT PREGNANCIES, SET
EXPECTATIONS FOR HOW THE RESULTS
WILL BE COMMUNICATE AND TESTING
MAY NOT DETERMINE THE CAUSE OF
DEATH BUT EMPHASIZE TESTING CAN
BE DONE TO DETERMINE THE CAUSE
AND EMPHASIZE THE BABY WILL BE
TREATED WITH CARE AND RESPECT.
FOR POSTPARTUM CARE WE NEED TO
ADDRESS THE NEEDS OF THE BIRTH
AND PROVIDE RECOVERY FOR
FIRST-TIME PARENTS INCLUDING
PHYSICAL RECOVERY FROM
POSTPARTUM DEPRESSION.
THE RISK OF DEPRESSION IS HIGH
IN PARENTS WHO EXPERIENCE
STILLBIRTH.
PROVIDE CLOSE POSTPARTUM
FOLLOW-UP IS ESSENTIAL AND
TRAUMA.
PROVIDE NATIONAL AND LOCAL
RESOURCES FOR SUPPORT AND CREATE
STANDARDS OF CARE FOR OTHER
PROFESSIONS SUCH AS SOCIAL
WORKERS AND CHAPLAINS WHO MIGHT
INTERACT WITH FAMILIES
EXPERIENCING STILLBIRTH AND
CONSIDER AVAILABILITY STILLBIRTH
TAX CREDIT.
SO OVER ALL RECOMMENDATIONS AND
THEMES THAT WENT ACROSS ALL
THREE GROUPS.
STANDARDIZING DATA COLLECTION
AND REPORTING, EXPLORING NEW
TECHNOLOGIES SUCH AS ARTIFICIAL
INTELLIGENCE AND MACHINE
LEARNING.
CREATING A STILLBIRTH PREVENTION
BUNDLE AND TRADING SO A WORKUP
INCLUDING AUTOPSIES, GENETIC AND
APPROPRIATE BLOOD TESTS ARE
PERFORMED.
CONDUCTING PERINATAL AUDITS
AFTER STILLBIRTH AND SPECIFIC
PROTOCOLS CAN BE DEVELOPED AND
RESEARCH WAYS INTO PRODUCING THE
HEALTH DISPARITIES IN STILLBIRTH
AND ESTABLISHING CONTINUING
HEALTH CARE PROVIDER EDUCATION
RELATED TO STILLBIRTH AND
RESEARCH THE MOST EFFECTIVE
MENTAL HEALTH SUPPORT AFTER
STILLBIRTH AND MAKING THE WORKUP
MORE AFFORDABLE INCLUDING ACCESS
TO AUTOPSY AND GENETIC TESTING
AND PLACENTAL PATHOLOGY.
IT'S BEEN A PRIVILEGE ALONG WITH
DR. JAIN TO CO-CHAIR THIS
WORKING GROUP.
THE AMAZING WORK OF THIS GROUP
ON AN IMPORTANT TOPIC.
I WANT TO THANK THE ENTIRE NICHD
TEAM, NATASHA WILLIAMS AND
OTHERS FOR KEEPING THE WORK
GROUP ON TASK AND ORGANIZED AND
KEEPING THE DOCUMENTS OF THE
MEETINGS ORGANIZED AND KEEPING
US ON TASK.
THE MANY EXPERTS ON STILLBIRTH
WHO ED THEIR TIME AND EXPERTISE
AND THE PARENTS AND FAMILIES WHO
COURAGEOUSLY SHARED THEIR
STORIES AND HOPING FOR
IMPROVEMENT IN THE STILLBIRTH
RATES IN THE U.S.
THANK YOU.
>> THANK YOU FOR CO-CHAIRING THE
WORKING GROUP.
THE DETAILED RECOMMENDATIONS.
THANKS TO THE NICHD STAFF AS
WELL AS THE OFFICE OF
LEGISLATION AND PUBLIC POLICY
AND ETHICS AND NOW IT'S OPEN FOR
QUESTIONS AND ANSWERS.
QUESTIONS FOR UMA AND LUCKY ON
THE STILLBIRTH REPORT.
THANK YOU FOR THIS INCREDIBLE
WORK AND PRESENTATION.
I HAD ONE SPECIFIC QUESTION ON
THE PERINATAL AUTOPSY.
THEIR BARRIERS TO ACCESS THAT
ARE VERY DIFFICULT TO OVERCOME
AND WONDERING IF IN YOUR WORK
YOU CONSIDER THE NON-INVASIVE
IMAGING BASED AUTOPSY THAT WOULD
BE EASIER TO ACHIEVE AND RELATED
TO THAT WHAT'S OFTEN EXPERIENCE
IS AFTER AN AUTOPSY IT TAKES A
LONG TIME TO GET THE FULL REPORT
BACK AND WITHIN YOUR
RECOMMENDATIONS MAYBE I DID MISS
IT.
I DID SEE SOMETHING ABOUT A
FUTURE RECONTACTING OF THE
FAMILIES FOR A PRECONCEPTION
VISITOR AND ENCLOSURE VISIT
RELATED TO A PREVIOUS
STILLBIRTH.
>> THESE ARE ALL EXCELLENT
COMMENTS.
A LOT OF IS THE DETAILS OF THE
REPORT AND HOW DIFFICULT IT IS
TO GET AN QUALITY AUTOPSY AND
DOING A FETAL MRI CONSIDERED
THAT.
SO THE RECOMMENDATION THAT WE
ARE NEVER GOING TO TRAIN ENOUGH
PATHOLOGISTS, DEVELOPING
REGIONAL CENTERS OF EXCELLENCE
WHERE THE EVALUATIONS CAN TAKE
PLACE.
TRYING TO INCREASE THE TRAINING
OF QUALIFIED PEOPLE BUT AS WELL
AS SHARING THE EXPERTISE SO IT'S
AVAILABLE ACROSS THE COUNTRY IN
DEVELOPING THE CENTERS OF
EXCELLENCE.
IN TERMS OF THE RESULTS COME
BACK, YES, MONTHS LATER AND
FAMILIES OFTEN DON'T EVEN HEAR
THE RESULTS.
SO MAKING SURE THEY GET
FOLLOW-UP ABOUT THE RESULT AND
MAKING SURE THEY GET
INCORPORATED INTO THE FETAL
DEATH CERTIFICATE AND YOU HAVE
TO DO A FORMAL LEGAL AMENDMENT.
WE HAD TO KEEP HEARING FROM
FAMILIES THE CAUSE OF DEATH WAS
WRONG AND THEY SPEND MONEY TO
TRY TO GET IT CORRECTED.
>> THERE'S ONGOING MENTAL HEALTH
SUPPORT WE HEARD OVER AND OVER
AGAIN HOW FAMILIES FELT
ABANDONED BECAUSE THAT TOO IS
HARD TO GET PERINATAL PSYCHIATRY
AND MENTAL HEALTH.
RESOURCES.
>> AND WHEN THEY HAVE SLEEPLESS
NIGHTS GOING FROM ONE PREGNANCY
TO ANOTHER THINKING MY NEXT BABY
IS GOING TO DIE.
>> GREAT COMPREHENSIVE REPORT
AND THERE'S SO MUCH TO DO.
I WANT TO MAYBE COMMENT ON THE
TRAINING ASPECT.
THERE ARE TRAINING COURSES AND
THERE'S A COURSE IN THE NIS AND
HELP PROVIDE THE TOOLS FOR
DOCTORS TO PROVIDE TOOLS GOING
THROUGH THE ORDEAL.
>> THE FACT THAT IT'S IN THE
REPORT SAYING TRAINING NEEDS TO
BE DONE AND THERE IS SPECIALIZED
TRAINING FOR HANDLING FAMILIES
THAT SUFFERED AS STILLBIRTH AND
THE PREGNANCY AFTERWARDS.
THERE'S WAY MORE CLINIC THE
START OF THE NEW K FOR FAMILIES
THAT HAVE EXPERIENCED
STILLBIRTH.
ADAPTING THE TRAINING AND
TAKING IT INTO THE CURRICULUM
AND RESIDENT PHYSICIANS DON'T
GET TRAINING ON HOW IT HANDLE
THIS.
>> AND HI, LUCKY AND UMA.
THANK YOU VERY MUCH.
IT'S IMPRESSIVE BOTH CONGRESS
AND NICHD WANTED TO FOCUS TO
ADDRESS RECOMMENDATIONS AND TWO
QUESTIONS.
THE FIRST IS THE CHALLENGE OF
NOT HAVING A STANDARDIZED
DEFINITION.
IT DEPENDS ON WHICH STATE YOU'RE
IN AND HOW IT'S DEFINED.
WAS THAT PART OF YOUR
RECOMMENDATION AND IF SO DID YOU
HAVE A STANDARD DEFINITION?
>> FOR MISCARRIAGE AND PREGNANCY
LOSS THIS FALLS UNDER THE CDC SO
STANDARDIZING THAT.
>> AND WHO IMPLEMENT THE
RECOMMENDATIONS?
HOW DO WE MOVE FORWARD AND YOU
MENTIONED THE IMPORTANCE OF WHO
COVERS THE COSTS?
>> THE REPORT ON THE PLACENTA
FETAL MOVEMENT MEDICAL
CONDITIONS, RISK FACTORS, FALLS
TO NIH A LOT OF THE DATA
COLLECTION PIECES FALL TO THE
CDC.
IN TERMS OF FUNDING TO GET OFF
THE RECOMMENDATIONS AND THE COST
OF THE WORKUP IS A REAL ISSUE
FOR FAMILIES.
IT'S NOT COVERED BY INSURANCE SO
THAT'S ANOTHER ASPECT AND CARE
AFTER HAVING THE STILL BIRTH A
LOT OF IT IS NOT COVERED.
>> IT'S AN EFFORT THAT HAS TO
INCLUDE INHERENTLY ORGANIZATIONS
LIKE THE CDC AND HEALTH AND
HUMAN SERVICES AND NIMHD BECAUSE
THERE'S DIFFERENT ASPECTS TO
TACKLING A MALADY SUCH AS
STILLBIRTHS.
THERE'S A BODY OF RESEARCH THAT
NEEDS TO BE DONE EVEN IF YOU
COME UP WITH A DEFINITION AND
SOMETHING ALL STATES ARE WILLING
TO ADOPT AND THAT'S WHERE THE
CDC COMES IN TO PLAY THAT THAT
MAYBE ONE WAY OF BRINGING THE
STATES TOGETHER.
ULTIMATELY IMPLEMENTATION
SCIENCE AND IMPLEMENTATION OF
THE WORK ITSELF NEEDS TO HAPPEN
AT THE STATE LEVEL WHERE MOST OF
THE HEALTH CARE IS MANAGED AND
THAT'S WHERE WE DON'T -- IT'S
VERY HARD TO CONTROL THAT OR
MANAGE THAT AS YOU KNOW.
>> THANK YOU SO MUCH FOR THIS
WORK.
I JUST WANTED TO AMPLIFY THE
PATHOLOGY.
I THINK FOR PREGNANT INDIVIDUALS
WHO GO THROUGH THIS THEY PERHAPS
DON'T REALIZE YOU NEED VERY
SPECIAL EXPERTISE TO BE ABLE TO
LOOK AT THE RESULTS AND THEY'RE
NOT PARTICULARLY INFORMATIVE AND
THINK THE CENTERS OF EXCELLENCE
WILL BE REALLY IMPORTANT.
THE OTHER QUESTION I HAD I THINK
YOU MENTIONED LUCKY THAT YOU HAD
AN EXTRA MILLION DOLLARS TO
CONTINUE TO WORK FOR THE NEXT
YEAR AND I WAS JUST WONDERING IF
YOU HAVE A CHANCE TO THINK ABOUT
WHAT YOUR PLANS ARE MOVING
FORWARD.
>> THE CONSIDERATION ASSIGNMENT
FUNDED THE WORK WE JUST
FINISHED.
IF THERE'S MORE WORK TO BE DONE
IN THE WORKFORCE.
>> WE'LL ASK DR. CHAKTURA TO LET
US KNOW WHAT'S HAPPENING IN
TERMS OF RESEARCH.
>> SO ABSOLUTELY.
THANK YOU.
WE'VE ALREADY PUBLISHED A NOTICE
OF INTENT TO PUBLISH.
WE'RE NOT CALLING THEM CENTERS
OF EXCELLENCE.
WE'RE CALLING THEM THE STILL
BIRTH CONSORTIUM AND THERE WILL
BE AN OPPORTUNITY TO HAVE MORE
DETAILS ON IT AND HOPEFULLY IT
WILL BE PUBLISHED THIS SUMMER
AND WE'RE HOPING TO TAKE SOME OF
THE RECOMMENDATIONS WITH IT INTO
RESEARCH AND EXPAND ON THEM SO
WE CAN HAVE -- WE CAN MOVE THE
FIELD FORWARD.
WE HAVE A THREE-PRONG STRATEGY
AND RECEIVED FUNDS FROM THE
FIRSTY YEAR TO BE ABLE TO EXPAND
ON THE DATA COMPONENT.
WE HAVE TWO NETWORKS AND SUPPORT
THROUGH THE MATERNAL MEDICINE
NETWORK AND WHAT WE WANTED TO DO
IS HAVE THEM WORK TOGETHER TO
IMPROVE THE COLLECTION OF DATA
THAT THEY HAVE.
SO TO BE ABLE TO COLLECT DATA
AROUND STILLBIRTH AND PRETERM
BIRTH AS WELL.
SO THAT'S THE FIRST STEP WITH
THE SMALL AMOUNT OF MONEY WE'VE
RESOU
RECEIVED BETWEEN THE TWO
NETWORKS WE HAVE OVER 230,000
DELIVERIES PER YEAR BETWEEN THE
TWO NETWORKS SO THAT'S A
SIGNIFICANT NUMBER OF DELIVERIES
AND POTENTIAL TO COLLECT DATA
AROUND STILLBIRTH.
THAT WAS THE FIRST STEP.
THE SECOND STEP IS WE RELEASED A
NOTICE OF SPECIAL INTEREST
AROUND STILLBIRTH AND RESOURCED
APPLICATIONS THAT HOPEFULLY WILL
BE REVIEWED IN JUNE AND WE'LL
SEE WHERE THAT GOES AND THE
THIRD STEP IS THE NOFOs OR THE
CONSORTIUM AROUND STILLBIRTH.
THESE ARE THE ACTIVES WE'VE BEEN
DOING.
IT'S A TRAGEDY TO SEE THE
IMPACT AND WONDERFUL TO SEE THE
COMPREHENSIVE APPROACH.
AND THESE ARE TRAINING
INDIVIDUALS HOW TO AT LEAST
ADDRESS CURRENT APPROACHES GIVEN
BEST PRACTICES THAT WE HAVE NOW
GIVEN THERE'S SO MUCH NOT KNOWN
WE DO AT LEAST CAN PROVIDE SOME
DEGREE OF SUPPORT FOR FAMILIES
AND THE ACADEMY CAN BE HELPFUL
AS WELL AS AND DOING ADVOCACY ON
THE HILL AND LOOKING AT PAYMENTS
AND THINGS YOU'VE MENTIONED.
AND WE KNOW ABOUT $2 MILLION WE
ESTIMATE -- THERE'S ABOUT 2
MILLION STILLBIRTHS AROUND THE
WORLD IN VARYING DEGREES OF
SOCIO DEMOGRAPHIC POSITIONS AND
STARTING TO THINK WITH
PARTNERING WITH WHO AND OTHERS
AROUND THE TOPIC BECAUSE IF IT'S
DIFFICULT IN THE U.S. IT'S
IMPOSSIBLE AROUND THE WORLD AND
WHILE WE'VE SEEN UNDER FIVE
CHILD MORTALITY DROP AROUND THE
WORLD IN THE LAST 30 YEARS,
STILLBIRTHS WE DON'T REALLY KNOW
THE TRUE BURDEN AND THAT BURDEN
AS FAR AS WE CAN MEASURE IS
STATIC OVER THE PERIOD THE LAST
MANY DECADES.
WE ONLY HAVE A MILLION DOLLARS
BUT PARTNERING WITH OTHER
ORGANIZATIONS SUCH AS AAP RIGHT
AWAY AND W.H.O. IN SOME LONGER
TERM WAY MIGHT BE USEFUL AS
WELL.
>> THAT'S A GREAT POINT, BONNIE.
I MENTIONED SOME OF THE WORK
THAT WE ARE THEN IN THE MIDDLE
OF DOING TO THE AMERICAN ACADEMY
OF PEDIATRIC EXECUTIVE DIRECTOR
WHEN I SAW HIM AT THE MEETING
RECENTLY.
SO THEY'RE AWARE BUT WE WILL
HOPEFULLY WORK WITH THE NICHD TO
MAKE SURE THE REPORT IS
CIRCULATED AND SOCIALIZED WITH
ALL LEADING AGENCIES THAT CAN
HELP FURTHER CONVERSATIONS
AROUND THIS AND FOUNDATIONS
WHERE SEVERAL OF THE WORK CAN BE
ENHANCED INCLUDING FOUNDATIONS
SUCH AS THE GATES FOUNDATION AND
OBVIOUSLY THE WORLD HEALTH
ORGANIZATION.
THE GOOD THING AND I'LL CONFIRM
THE GOOD THING ABOUT THIS WAS
THAT WE HAD SEVERAL LEADING
MEMBERS OF THE INTERNATIONAL
COMMUNITY IN STILLBIRTHS
RESEARCH AND IMPLEMENTATION
SCIENCE INCLUDING PEOPLE FROM
THE SCANDINAVIAN COUNTRIES,
ENGLAND
>> AFTERWARDS WITH THE NEXT
PREGNANCY LUCKY MENTIONED IT AS
THE A DREAD EVERY TIME THE
BIRTHING PATIENT COMES IN THAT
THERE'S GOING TO BE ANOTHER
STILLBIRTH.
THE FAMILIES STILL TRAUMATIZED
THINKING ABOUT IT.
SO I THINK INVOLVING
PEDIATRICIANS AND TRAINING IS
REALLY IMPORTANT.
AND THE GLOBAL NETWORK AND GATES
ARE DOING IMPORTANT WORK ON
STILLBIRTH INTERNATIONALLY BUT
COLLABORATING WITH THEM AND AS
LUCKY MENTIONED WE DID
COLLABORATE WITH THE STILLBIRTH
BUNDLE THAT BULLET POINT ABOUT
BEST PRACTICES SO WE HAD LEADING
EXPERTS FROM THE U.K. AND
NETHERLANDS OF AUSTRALIA DISCUSS
THEIR STILLBIRTH BUNDLES AND
HAVE RATES OF 2-3 TO OUR 1.7 PER
1,000.
>> THERE ARE GROUPS BONNIE LIKE
THE GROUP IN UTAH LED BY DR. BOB
SILVER WHO HAVE NOW FORMED
INTERNATIONAL MOVEMENTS AROUND
STILL BIRTH, BIRTH PREVENTION.
MANY PEOPLE WERE PART OF THIS
EXERCISE WITH US.
YOUR POINT IS REALLY WELL TAKEN.
I THINK WE NEED TO EXPAND THE
IMPACT OF THE WORK GLOBALLY AS
WELL.
THANK YOU.
>> IS THERE ANY FURTHER
DISCUSSION.
>> WE WERE THINKING ABOUT THE
IMPACT ON THE FAMILY.
WITH TRAINEES AND RESIDENTS
THEY'RE PRETTY TRAUMATIZED WHEN
THAT HAPPENS AS WELL.
IT'S NOT JUST TRAINING AROUND HU
TO INTERFACE WITH THE PATIENTS
BUT ALSO HOW TO INTERFACE WITH
ONE'S OWN FEELINGS AROUND THE
DEATH.
AND THIS IS SUCH IMPORTANT WORK
AND I WANT TO COMMEND YOU ON THE
WORK YOU'VE DONE AND
PARTICULARLY ON THE FACT THAT
YOU'VE HIGHLIGHTED THE DISPARATE
EXPERIENCES OF DIFFERENT PEOPLE
BECAUSE THEY'RE REAL AND HAVE
IMPACTS ON NOT JUST THE PATIENT
BUT THE FAMILY SO THANK YOU FOR
THAT.
>> WE'RE DEVOTED TO HEARING FROM
EXPERIENCES AND WE HEARD FROM
FATHERS AND HOW THEY WERE
PROFOUNDLY AFFECTED.
IT WAS INTENSE THE WHOLE
SESSION.
WE ALL NEEDED TISSUES.
WE CAN SAY IT AFFECTS THE
FAMILIES BUT IT REALLY AFFECTS
THE FAMILIES.
I'M SORRY, LUCKY, I INTERRUPTED
YOU.
>> NO, I WANTED TO MENTION THE
FACT THAT PARTICIPATION OF THE
MOTHERS WHO HAVE LIVED THROUGH
THIS EXPERIENCE WAS ONE OF THE
MOST MOVING PARTS OF THIS ENTIRE
UNDERTAKING AND GLAD YOU
MENTIONED THE DADS WHO WERE --
WE'RE NOT NORMALLY NOTICED IN
THE WHOLE OCCURRENCE BUT YOU'RE
ABSOLUTELY RIGHT.
THE FAMILIES THAT ARE IMPACTED
DISPROPORTIONATELY ARE THE ONES
WHO ALSO DON'T GET APPROPRIATE
FOLLOW-UP CARE OR ANY CARE
BEYOND THAT.
>> THERE'S A HIGHER RATE OF
DIVORCE.
IT IS TRAUMATIZING AND AS A
PHYSICIAN YOU FEEL INCREDIBLE
GUILT AND IT'S A TRAUMATIZING
WHEN YOU'RE PATIENT HAS A
STILLBIRTH.
I THINK HELPING PROVIDERS DEAL
WITH THE SITUATION AS WELL
BECAUSE IF WE DO PROPER TRAINING
AND IT WILL BE MORE AVAILABLE TO
FAMILIES AND BETTER ABLE TO DEAL
WITH THE SITUATION FOR FAMILIES.
>> THANK YOU TO ALL THE MEMBERS
OF THE WORKING GROUP, CYNTHIA
SERVED ON THE WORKING GROUP.
THANK YOU TO OUR STAFF AND MAY I
HAVE A MOTION NOW FOR APPROVAL
OF THE WORKING GROUP'S REPORT.
>> MOVE TO APPROVE.
>> MAY I HAVE A SECOND.
>> SECOND.
>> THANK YOU.
WE'LL HAVE A VOTE NOW.
YOU'RE VOTING FOR APPROVAL.
>> AGAIN WE HAVE 13.
WE'LL FIGURE OUT WHO IS ACTUALLY
ABLE TO VOTE.
WE HAVE WHAT WE NEED.
WE NEED TO LEARN HOW TO COUNT.
WE NEED TO INFORM PEOPLE THAT
HAVE NOT BEEN CLEARED YET THEY
CAN'T VOTE.
WE'LL FIGURE IT OUT.
SO WITH THAT I KNOW IT'S BEEN A
LONG DAY, THERE'S BEEN A LOT OF
INFORMATION THROWN AT YOU.
THE GOOD NEWS IS WE'RE COMING TO
AN END.
THIS IS CONCLUDE ROING --
CONCLUDING THE FIRST DAY OF OUR
ADVISORY MEETING.
I WANT TO THANK YOU ALL IN
PERSON AND VIRTUALLY AND STAFF
FOR PARTICIPATING IN TODAY'S
ACTIVITIES.
WE LOOK FORWARD TO SEEING
EVERYONE TOMORROW.
THERE'LL BE A BRIEF OPEN SESSION
FIRST THAT WILL BE CONCEPT
CLEARANCE AND THEN IT WILL
BECOME A CLOSED MEETING WHEN WE
WILL DISCUSS SPECIFIC PROPOSALS.
SO THANK YOU ALL.
HAVE A WONDERFUL EVENING AND
WE'LL SEE YOU TOMORROW.