>> WELCOME EVERYONE.
IT'S SO LOVELY TO SEE TO MANY OF
YOU IN THE ROOM AND BE IN PERSON
WITH YOU AFTER OUR MANY MONTHS
OF WORKING TOGETHER.
I HAVE A COUPLE HOUSEKEEPING
ANNOUNCEMENTS BEFORE I PASS IT
TO THE CO-CHAIR.
SINCE WE'RE RUNNING A HYBRID
MEETING I WANT TO MAKE SURE
FOLKS AND IF YOU'RE IN THE ROOM
AND SPEAKING, PLEASE IDENTIFY
YOURSELF BEFORE YOU BEGIN SPEAK
AND TURN THE MICROPHONE ON AND
WE'LL ALL NEED TO BE SPEAKING
INTO A MICROPHONE.
FOR THOSE OF YOU ON THE ZOOM,
WHEN IT COMES TO QUESTIONS AND
ANSWER, WE'LL BE MONITORING THE
CHAT SO YOU CAN PUT QUESTIONS IN
THE CHAT AND/OR USE THE RAISE
HAND FUNCTION AND WE'LL CALL ON
YOU TO MAKE SURE YOU CAN
PARTICIPATION AND EVERYONE IN
THE ROOM CAN SEE YOU.
I ALSO WANT TO MENTION WE HAD A
COUPLE FOLKS DISCLOSE POTENTIAL
CONFLICTS OF INTEREST BUT GIVEN
THE TOPICS WE'RE DISCUSSING
TODAY I MADE SURE WE DON'T NEED
TO WORRY ABOUT THAT.
IF YOU NEED HELP WITH WI-FI OR
ANYTHING LIKE THAT LET US KNOW
AND THERE'S COFFEE AND WATER ON
THE TABLE AND THEY'RE BY
NON-APPROPRIATED FUNDS AND REST
ROOMS IN THE HALL.
I WANT TO MAKE SURE EVERYONE IS
WELL TAKEN CARE OF AND WITH THAT
I'LL HAND IT TO THE CO-CHAIR TO
DIVE IN.
>> THANK YOU, EMMA.
I'LL REITERATE WHAT EMMA SAID,
FIRST THANK YOU FOR TAKING TIME
FROM YOUR BUSY SCHEDULES AN TO
TAKE OUT TO BE HERE WITH US
TODAY.
IT'S REALLY IMPORTANT FOR THE
SPACE AND CRITICALLY IMPORTANT
FOR WOMEN PREGNANT AND LACTATING
TO FIND A PATH FORWARD TO MEET
THEIR NEEDS.
WE'RE THRILLED TO HAVE YOU HERE
TODAY.
I'M REALLY THANKFUL TO THE NICHD
STAFFERS FOR PROVIDING SOME
WATER AND COFFEE AND SNACKS TO
US.
THIS IS A TRUE PERSONAL
APPROPRIATION THEY HAVE
CONTRIBUTED TO SO PLEASE TAKE
ADVANTAGE SINCE THEY WENT OUT OF
THEIR WAY.
FOR TODAY WE HAVE AN AGENDA THAT
IS SCHEDULED THROUGH THE DAY.
THE MORNING IS GOING TO BE A
REPRODUCTION OF THE WORK WE'VE
BEEN DOING OVER THE COURSE OF
THE LAST FEW MONTHS AND THE
AFTERNOON IS AN OPPORTUNITY TO
COME TOGETHER TO DISCUSS THE
OUTSTANDING ELEMENTS OF OUR WORK
TOGETHER BUT ALSO TO ENSURE THAT
WE'RE REALLY CLEAR ON WHAT YOU
IDENTIFIED AS KEY THEMES WE NEED
TO ENSURE TO BUILD INTO THE
REPORT WE'LL ULTIMATELY BE
SUBMITTING TO CONGRESS.
WE WANT TO HEAR FROM ALL OF YOU
ABOUT WHAT YOU SEE IS THE KEY
ELEMENTS THAT SHOULD GO INTO THE
REPORT.
WITH THAT I THINK WE CAN MOVE TO
THE NEXT SLIDE.
TO PROVIDER AN OVERVIEW OF THE
PRGLAC PLAN WE'VE MAPPED
PROGRESS TO DATE ON
IMPLEMENTATION AND TODAY WE'LL
BE THE REMAINING RECOMMENDATIONS
WHICH ARE THREE, FIVE AND SIX.
IF YOU LOOK TO LACTATION YOU CAN
SEE THE STATUS, YOU SEE A
RELATIVELY SIMILAR LOOK GRAPHIC.
THERE'S A COUPLE RECOMMENDATIONS
FOR LACTATION THAT ARE NOT
APPLICABLE TO LACTATION AND YOU
SEE AN N.A. FOR RECOMMENDATION
FOUR BUT WE'VE ALSO BEEN ABLE TO
NICELY CHARACTERIZE THE STATUS
FOR LACTATION.
AND HERE IN THE WORK GROUP OUR
JOB IS TO VAEFLT THE STATUS OF
THE IMPLEMENTATION PLAN AND
CREATED THROUGH THE CONSOLIDATED
ACT OF 2003.
WE DO HAVE A SPECIFIC TASK TO
ASSESS HOW FAR WE'VE BEEN ABLE
TO PROGRESS, WHERE THERE IS
STILL NEED FOR FURTHER PLANNING
AND IMPLEMENTATION POTENTIALLY
RESOURCE AND ACTION IN ORDER TO
SEE THE INTENTION OF THE PLAN
COME TO FRUITION.
>> WE CAN'T SEE ANY OF THE
SLIDES ON THE ZOOM.
IS IT POSSIBLE TO HAVE THE
CAMERA PIVOT TO THE SLIDES?
>> IT'S BEING WORKED ON NOW SO
OUR APOLOGIES IN ADVANCE.
>> THANK YOU.
>> CAN YOU GIVE US AN
AFFIRMATIVE YOU'RE ABLE TO SEE
THEM.
>> WE CAN SEE THEM.
>> PERFECT.
JUST TO REMIND EVERYONE WHERE WE
ARE.
OUR WORK GROUP WAS PUT INTO
PLACE BY RECOMMENDATION 15 LAID
OUT SO WE'RE GLAD TO HAVE SEEN
THE FORESIGHT OF THE
IMPLEMENTATION WORKING GROUP TO
ESTABLISH THIS REVIEW WORK GROUP
OF COUNCIL.
OUR JOB IS TO REVIEW WHAT'S
AVAILABLE PUBLICLY TO DATE AND
IT'S IMPOSSIBLE TO REVIEW
EVERYTHING IN THE SPACE AND YOUR
COMMENTS WILL BE HIGHLY VALUED.
WE HAVE SPEAKERS TODAY THAT ARE
GOING TO BE REPRESENTING FEDERAL
ENTITIES TO REVIEW THE
INTENTIONS FOR TODAY'S
DISCUSSION AND ALL OF OUR WORK
WILL CULMINATE IN A REPORT
THAT'S GOING TO BE MADE TO
COUNCIL AND ULTIMATELY SUBMITTED
TO CONGRESS.
AND OUR PURPOSE IN THAT REPORT
IS TO GO BOTH SPEAK TO THE
STATUS OF THE IMPLEMENTATION
PLAN AND ALSO TO PROVIDE
RECOMMENDATIONS WHERE WE THINK
RECOMMENDATIONS MAY BE NEEDED TO
BETTER FACILITATE SOME OF THE
RECOMMENDATIONS THAT HAVE ARE
NOT OF YET BEEN ABLE TO BE
ACTIONED.
IF THERE IS RECONSIDERATION OF
THE RECOMMENDATIONS WE FEEL
COULD BE NEEDED.
THROUGH THE WORK TO DATE WE'VE
WORKED THROUGH CLUSTER C ON
LIABILITY AND D, REGISTRIES AND
E ON NOVEL DRUG DISCOVERIY AND
DEVELOPMENT AND WE'LL FOCUS ON
CLUSTER B, EDUCATION OUTREACH,
TRAINING AND CAREER DEVELOPMENT.
TO FACILITATE THAT IN THE FIRST
SESSION WE'LL HAVE SPEAKERS FROM
NICHD, THE AMERICAN COLLEGE OF
OBSTETRICS AND GYNECOLOGY AND
THE SOCIETY FOR MATERNAL FETAL
MEDICINE PROVIDING ACTIONS TO
DATE.
AND WHILE SESSION 1 WILL
PRIMARILY FOCUS ON
RECOMMENDATION 3, WE'LL ALSO
BRING IN ELEMENTS THAT SPEAK TO
RECOMMENDATIONS 5 AND 6 AND
WE'RE FULLY AWARE OF THAT SO
DON'T FEEL YOU CAN'T SPEAK TO
THAT ON THE DISCUSSION
COMPONENT.
IN SESSION 2, WE'LL HAVE
SPEAKERS WHO ARE GOING TO BE
COMING TO US FROM THE CDC AND
FROM ACTIVITIES PUT IN PLACE
EXTERNAL TO SOCIETY.
WE WANT TO HEAR FROM YOU HOW THE
ACTIONS FIT INTO THE
RECOMMENDATION PLANS.
THIS IS NOW MAPPING WHAT OUR
MORNING IS GOING TO LOOK LIKE
AND THE DISCUSSION THAT WILL
ENSUE.
I THINK THAT TAKES US TO SESSION
1.
SO FROM HERE I'LL TURN THINGS
OVER.
>> THANKS, CHRISTINA.
I WANT TO CALL OUT NATASHA,
LAURA AND EMMA DOING AN AMAZING
JOB COORDINATING THE WORK GROUP
AND DONE THE HEAVY LIFTING AND
MADE OUR JOB EASIER AND MADE
SURE THE BUDGET WAS PASSED AND
THEY WENT ABOVE AND BEYOND.
IN SESSION 1 WE'LL DISCUSSION
RECOMMENDATION 3.
THERE'S SEVERAL THINGS WE WANT
TO LISTEN FOR, WITH RESPECT TO
3A WE'RE TRYING TO UNDERSTAND
TRADITIONAL OPPORTUNITIES AND
Ts, Ks, Rs, DIVERSITY
SUPPLEMENTS AND NON-EDUCATIONAL
OPPORTUNITIES, CERTIFICATION AND
INTEGRATION WITH PROGRAMS AND
ADDRESS SALARY ISSUES AND
EFFORTS MADE TOWARDS INCREASING
THE AWARENESS OF THESE
OPPORTUNITIES.
RECOMMENDATION 3B, DISCUSSES
SUPPORTING, CONNECTING MENTORS
AND TRAINEES AND SUPPORTING
MENTORS THEMSELVES AND WITH
RESPECT TO 3C WE'RE LOOKING AT
EXPANDING TOXICOLOGY TRAINING
OPPORTUNITIES, EDUCATIONAL
REQUIREMENTS INCLUDING
ELECTRONIC HEALTH RECORD MODULES
THAT FOSTER CLINICAL TRIALS
PARTICIPATION.
THESE ARE THINGS WE WANT TO
LISTEN FOR AS WE LOOK TO HOW
EFFECTIVELY RECOMMENDATION 3 HAS
BEEN IMPLEMENTS.
WITHOUT FURTHER ADO I'LL
INTRODUCE YOU TO OUR SPEAKERS.
WE'VE GOT DR. BATE WITHIN THE
OFFICE OF OBSTETRIC AND
PEDIATRIC PHARMACOLOGY NICHD AND
RACHEL TEFLA FOR ACON AND
REBECCA ABBOT FOR THE SOCIETY OF
MATERNAL AND FETAL MEDICINE.
I'LL TURN IT OVER TO LESLIE AND
ASK HER TO GET US STARTED.
>> ARE YOU ABLE TO SEE MY FIRST
SLIDE IT'S A TITLE PAGE.
>> THANK YOU FOR HAVING ME AND
THANK YOU FOR THE OPPORTUNITY TO
TALK ABOUT TRAINING AND
MENTORSHIP AND PARTICULARLY OUR
TRAINING NETWORK.
SO, MY NAME IS LESLIE BATES FOR
THE PHARMACOLOGY TRAINING
NETWORK.
OVER THE NEXT COUPLE SLIDES I
PLAN TO INTRODUCE OUR NETWORK,
HIGHLIGHT HOW OUR NETWORK HAS
EVOLVED AND PERHAPS SHOWCASE
SOME SUCCESSES.
THE TRAINING NETWORK WAS FORMED
IN RESPONSE TO THE
PHARMACEUTICALS ACT REQUIRING
PHARMACOLOGISTS TO BE INCLUDING
IN EXISTING CAREER DEVELOPMENT
PROGRAMS.
THIS WAS INITIALLY FORMED IN
2011 BIT THE OBSTETRIC AND
PEDIATRIC BRANCH WHICH PROPOSED
TO PREPARE INDIVIDUALS TO
CONDUCT IMPACTFUL RESEARCH AND
CAREER DEVELOPMENT OF YOUNG
INVESTIGATORS.
THIS ALLOWS FOR
INTERDISCIPLINARY COLLABORATION
AMONG CLINICAL, TRANSLATIONAL
AND BASIC INVESTIGATORS WHO
STUDY PEDIATRIC THERAPEUTICS.
SO AT THE INCEPTION THE NETWORK
WAS ORIGINALLY CALLED THE
PEDIATRIC PHARMACOLOGY TRAINING
NETWORK AND IN 2003 IT WAS
RENAMED TO HAVE TRAINING AND
PHARMACOLOGY ALONG OUR PEDIATRIC
FOCUS.
OUR CURRENT PROGRAM IS BEING
CO-FUNDED TO FULLY FUNDED BY
NICHD AND IT SUPPORTS TRAINEE
FUNDED THROUGH F, P AND K
MECHANISMS.
THE PURPOSE OF OUR TRAINING
PROGRAM THE PURPOSE OF OUR
ENHANCEMENT AND EVOLUTION IS TO
ENSURE AND HIGHLY DIVERSE
WORKFORCE IS AVAILABLE IN
PHARMACOLOGY AND THERAPEUTICS.
A LITTLE ABOUT OUR CURRENT
NETWORK.
IT'S DESIGN TO STRENGTHEN AND
DIVERSIFY THE CLINICAL AND
BIOMEDICAL WORKFORCE.
AS YOU CAN SEE IT'S COMPRISED OF
MANY COMPONENTS.
THESE ARE INTENDED TO PROVIDE
WHAT WE CONSIDER A ROBUST
TRAINING MENTORSHIP IN PEDIATRIC
PHARMACOLOGY.
I THINK MOST OUTWARD FACING
COMPONENT IS OUR LECTURE SERIES.
THE LECTURE SERIES BEEN DESIGN
TO MEET THE NEEDS OF
PHARMACOLOGY STUDENTS WHO LACK A
FORMAL EDUCATION CURRICULUM.
IN ADDITION, WE HAVE INCLUDED
WORKSHOPS AND THESE HELP TO
PROMOTE ACTIVE ENGAGEMENT WITH
FELLOW PEERS AND FOUND IT HELPS
CULTIVATE COLLABORATION AND
THEY'VE BEEN ABLE TO LEVERAGE
COOPERATION FROM OTHER SITES
WITHIN THE NETWORK AND
INTERDISCIPLINARY COLLABORATION
AND SEVERAL TRAINEES HAVE
PUBLISHED MANUSCRIPTS MOST
RECENTLY A WHITE PAPER.
THE NETWORK FOSTERS INTERACTIONS
WITH OTHER NICHD NETWORKS TO
CREATE OPPORTUNITIES FOR
PROFESSIONAL DEVELOPMENT.
SOME EXAMPLES INCLUDING
OPPORTUNITIES WITH OUR PEDIATRIC
PROUD NETWORK.
THE NETWORK I THINK IS IN A
UNIQUE POSITION NOT TO ONLY FOR
THE P.I. FELLOW MENTORSHIP BUT A
PEER-TO-PEER MENTORSHIP AS WELL.
WE HAVE A PRETTY EXPENSIVE AND
INTERACTIVE ALUMNI NETWORK WHICH
CAN BE PARTICULARLY VALUABLE
WHEN WE'RE LOOKING AT THE
PEER-TO-PEER MENTORSHIP.
WE'RE BIG ON SEEING SCIENCE AND
FOSTERING COLLABORATION.
WE ENCOURAGE UNIQUE AND
INNOVATIVE RESEARCH EXPERIENCES.
AND I THINK WHAT MAKES OUR
NETWORK UNIQUE IS THAT WE HAVE
AN ABILITY TO CONNECT OVER
SEVERAL SITES FELLOW MENTORS
ACROSS MULTIPLE SITES ACROSS THE
UNITED STATES AND PROVIDE A
COMPREHENSIVE TRAINING
EXPERIENCE.
I MENTIONED WE HAVE SITES ALL
OVER THE U.S.
THE NETWORK WAS PART OF A LARGER
NETWORK CO-FUNDED WITH NICHD AND
WE'RE NOW TRANSITIONING TO FULLY
FUNDED NICHD NETWORK.
I DO WANT TO MENTION WE HAVE
TRAINEE ARE NOT FUNDED BY NICHD
THAT STILL PARTICIPATE IN THE
NETWORK DESPITE THE LACK OF
AFFILIATION AND I THINK IT
SPEAKS TO THE VALUE OF THE
NETWORK.
LISTED HERE I DO HAVE OUR
CURRENT SITE AND NOT TO SAY
FUTURE COLLABORATIONS WITH OTHER
INSTITUTES ARE NOT POSSIBLE BUT
RIGHT NOW WE ONLY HAVE OUR NICHD
FUNDED SITES.
I WANT TO HIGHLIGHT A COUPLE
SITES.
THERE'S A COUPLE P32 PROGRAMS
AND ONE THAT IS NOT CLINICAL
PHARMACOLOGY BUT HAVE BEEN
ACTIVE IN THE NETWORK AND WE'VE
NOW CONSIDERED THEM AN
AFFILIATED PROGRAM.
WE RECENTLY HAVE GIVEN
PREDOCTORAL AND POST-DOCTORAL F
MECHANISMS TO JOIN THE NETWORK
AND AGREED TO BE ACTIVE IN OUR
OPPORTUNITIES.
IT HELPS BRING MORE DIVERSITY IN
THE NETWORK IN TERMS OF
BACKGROUND AND CAREER PATH.
WE RECENTLY INCLUDED K12
SCHOLARS.
WE HAVE TWO PROGRAMS.
THE LAST COUPLE YEARS WE HAD
ENHANCEMENT PLANS FOR THE
NETWORK AND PLEASED TO SAY WE'VE
CHECKED SEVERAL AND ONE IS THE
K12 EXTENSION.
OUR GOAL IS DEVELOPMENT AND
PRODUCTIVITY TO A MORE ADVANCED
SUPPORT MECHANISM.
WE MOVED FORWARD WITH THE
INCLUSION OF K12 SCHOLARS WHICH
ARE OUR CAREER DEVELOPMENT
SCHOLARS.
OUR NETWORK IS TRYING TO
LEVERAGE WHAT WE'VE DONE WITH
THE T MECHANISM OR POSTDOC
FELLOWS TO ENHANCE DEVELOPMENT
OF OUR K SCHOLARS AS WELL.
FOR THOSE WHO AREN'T FAMILIAR
WITH THE MECHANISM IT PROVIDES
AN OPPORTUNITY FOR SCHOLARS TO
CONDUCT RESEARCH AT
INSTITUTIONS.
HAVE THE PROTECTIVE TIME AND
WHAT MAKES OUR K PROGRAM UNIQUE
IS THAT WE HAVE A NATIONAL
NETWORK.
APOL
APOLOGIES.
WHAT MAKES IT UNIQUE IS IT'S A
NATIONAL PROGRAM.
WE HAVE TWO PROGRAMS SIX FLIGHTS
BUT THE K SCHOLARS ARE NOT
REQUIRED TO COME FROM THE
PROGRAMS.
THOSE DO HAVE SOME SCHOLARS THAT
ARE AT SITES THAT DON'T
TRADITIONALLY HAVE A CLINICAL
PHARMACOLOGY PROGRAM.
I CAN TALK MORE ABOUT IN OUR Q&A
HOW THAT WORKS BUT A KEY
REQUIREMENT OF THE K12 WAS TO
FOCUS ON INSTITUTIONS THAT
HISTORICALLY HAVE NOT HAD STRONG
PROGRAMS IN THIS PHASE AND THIS
HELPED CAST A WIDER NET.
I WANT TO TOUCH ON HIGHLIGHTS OF
THE NETWORK.
WE HOLD ANNUAL MEETINGS WHERE
SECOND AND THIRD YEAR TRAINEES
HAVE OPPORTUNITIES TO SHOWCASE
THEIR WORK.
FIRST YEAR TRAINEES ARE ABLE TO
COME AND CONNECT WITH OTHER
TRAINEES AND WE RECENTLY
IMPLEMENTED A TRAINING PROGRAM
WHERE TRAINEES AND SCHOLARS ARE
PROVIDED WITH A FOUNDATION OF
WHO IS WHO IN THE INSTITUTE.
WE HAVE ENHANCED OUR CURRENT
LECTURE SERIES TO INCLUDE
FELLOWS ONLY WORKSHOP TO MEET
SPECIFIC NEEDS OF THE TRAINEES.
FOR EXAMPLE, GRANT WRITING OR
HOW TO BALANCE CLINICAL AND
RESEARCH DUTIES.
WE DO HAVE THE NEW K12
EXTENSION.
WE HAVE SCHOLARS RECENTLY
APPOINTED ARE SET TO JOIN IN THE
SPRING.
WE DO HAVE INFORMAL MEMBERS OF
THE NETWORK.
WE MENTIONED THE F MECHANISM AND
WE HAVE POTENTIALLY A K99
AWARDEE.
WE HAVE SEVERAL POTENTIAL F31s,
F32s.
I ALSO WANTED TO HIGHLIGHT OUR
ALUMNI NETWORK WHO REMAINS
EXTREMELY ACTIVE SERVING AS
SPEAKERS FOR THE LECTURE SERIES,
MENTORS FOR THE CURRENT TRAI
TRAINEES, THEY HELP IMPROVE
TRAINEE EXPERIENCES.
WE CONDUCTED A FELLOW SURVEY FOR
CURRENT FELLOWS AND RECENTLY
GRADUATED AND IT'S WAYS WE SEEK
TO IMPROVE OUR OVER ALL TRAIN
JAE EXPERIENCES.
-- TRAINEE EXPERIENCES.
I'M GOING TO TRY TO MOTOR
THROUGH A LITTLE BIT.
WE IS OUR LECTURE SERIES WE'VE
ENHANCED A LITTLE BIT.
THIS ILLUSTRATION REPRESENTS THE
DATA FROM LAST YEAR'S SERIES.
ORANGE IS THE NUMBER OF
ATTENDEES, TRAINEES, INDIVIDUALS
FROM ACADEMIA, INDUSTRY,
GOVERNMENT, I DO HAVE
HIGHLIGHTED IN YELLOW THE FELLOW
CENTRIC WORKSHOPS AND GRANT
WRITING AND WE HAD A SPEAKER
TALK ABOUT ELEVATING YOUR
ELEVATOR PITCHES AND NEGOTIATING
TIPS AND HAD A SPEAKER TALK
ABOUT NAVIGATING THE GRANT
SUBMISSION AND REVIEW.
INSIGHT TO THE NIH STUDY
SECTION.
ON THE RIGHT WE HAVE THE
LECTURES WITH THE HIGHEST
TURNOUT.
4:THEY REPRESENT NOT
THEY REPRESENT NOT ONLY THE
FOUNDATIONS OF PEDIATRIC
PHARMACOLOGY BUT TRY TO ADDRESS
TOPICS OF INTEREST TO OUR
SCIENTIFIC COMMUNITY.
WHAT MIGHT OF INTEREST TO THIS
GROUP IS WE'RE PLANNING EXPAND
TO STRENGTHEN TRAINING AND
RESEARCH EFFORTS IN SUPPORT OF
OUR BRANCH'S MORE UNIFIED VISION
AND SIMULTANEOUSLY EMBRACING
PEDIATRIC AND PHARMACOLOGY
INITIATIVE AND PREGNANT AND
LACTATING WOMEN ARE A FOCUS OF
THE THEME 5 AND ADVANCEMENT OF
THERAPEUT
THERAPEU
THERAPEUTICS RESTORING THE
FOUNDATION OF HEALTHY
PREGNANCIES AND PLAN TO PROMOTE
MATERNAL RESEARCH AS WELL.
AGAIN I WANT TO HIGHLIGHT OUR
NETWORK OFFERINGS AND
EXPECTATIONS.
GET OUR PROGRAMS AND P.I.s AND
FELLOWS ENGAGED.
ONE EXPECTATION ON BOARD IS
THEY'LL PARTICIPATE AS THE
PROGRAM GROWS AND IN THE CURRENT
STATE.
SO FAR WE'VE HAD GOOD
PARTICIPATION WE HAVE THE NOTICE
OF AWARD AND I SPEAK TO THE
PROGRAMS WE REITERATE THEIR
PARTICIPATION IS VALUABLE TO THE
NETWORK AND WILL BE A VALUE TO
THEM AS WELL WITH THE
EXPECTATION WE'D LIKE IT SHARE
WHAT THE NETWORK IS ABLE TO
OFFER.
WE HAVE RESEARCH INNOVATIVE
RESEARCH EXPERIENCES, CLINICAL
EXPERIENCES IN OUR MONTHLY
NEWSLE
NEWSLETTER.
WE INTEREST TO PROVIDE JOB
POSTINGS AND SOME OPPORTUNITIES
PROVIDED DIRECTLY FROM THE
NETWORK AND LIKE TO SHARE
OPPORTUNITIES PROVIDED BY NIH
INCLUDING THE PRINCIPLE TO
PHARMACOLOGY COURSE.
WE ALSO LIKE TO KEEP UP WHERE
FELLOWS GO.
WE USE SEVERAL METRICS TO
EVALUATE THE PROGRAM INCLUDING
PUBLICATIONS, NUMBER OF
INDEPENDENT GRANTS, CAREER POST
FELLOWSHIP AND ACADEMIA AND THE
HOSPITAL SETTING BUT WE'RE
HOPING TO START EVALUATING MORE
OF THE FELLOW'S ROLE RATHER THAN
JUST THE SETTING.
A FELLOW THAT CREATES THEIR OWN
START-UP FOR A NEW PEDIATRIC
DRUG DELIVERY SYSTEM SHOULD BE
HIGHLIGHTED AND CONSIDERED A
PROGRAM SUCCESS.
JUST BECAUSE THEY HAVEN'T
ENTERED ACADEMIA.
OUR GOALS IS TO HAVE FELLOWS IN
THEIR CLINICAL RESEARCH SPACE
STAY CONNECTED TO THE COMMUNITY
AND REALLY CONTINUE THEIR
RESEARCH EFFORTS IN PEDIATRIC
CLINICAL PHARMACOLOGY.
AND I WANTED TO END THE
PRESENTATION WITH SOME OF OUR
NETWORK FEEDBACK.
WE DO SEND OUT SURVEYS.
THESE ARE JUST SOME OF THE
QUOTES SHOWING WHAT WE'RE DOING
IN THE NETWORK IS DOING AND OVER
ALL WE'VE HAD GOOD FEEDBACK
ABOUT THE NET YORK AND THE
FELLOWSHIP PROVIDING A GOOD
FOUNDATION AND MOVE THEM INTO
THE NEXT PHASE OF THEIR CAREER.
HIGHLY BE HAPPY TO TAKE
QUESTIONS NOW OR DURING THE Q&A
SESSION.
>> THANK YOU, LESLY.
WE HAVE A FEW MINUTES FOR CARE
CLARIFYING QUESTIONS AND SHE'LL
BE HERE FOR THE Q&A AS WE EXPAND
THE DISCUSSION.
>> THIS IS EXCITING TO SEE THE
EXPANSION AND LEVERAGING OF THE
NET YORK.
I'M KATIE SCHUBERT FOR THE
SOCIETY FOR WOMEN'S HEALTH
RESEARCH AND WANTED TO ASK YOU
ABOUT THE EXPANSION AND WHETHER
THE NETWORK HAS THE NECESSARY
RESOURCES AS YOU'RE THINKING
ABOUT THE POTENTIAL DEMAND OR
INTEREST IN MOVING TO THE
MATERNAL AND PEDIATRIC SIDE.
>> GREAT QUESTION.
SOMETHING WE THOUGHT ABOUT.
CAN THE INFRASTRUCTURE LEVERAGE
WHAT WE HAVE AND BUILD ON THE
MATERNAL PHARMACOLOGY COMPONENT.
WE HAVE PLANS IN PLACE TO BRING
OTHER INSTITUTIONS, OTHER SITES,
OTHER EXPERTISE IN TO HELP
SUPPORT THAT.
AT THIS POINT I THINK WHAT WE
HAVE IN MIND IS MORE OF AN IDEA
AND LESS OF A BLUEPRINT AND OPEN
TO SUGGESTIONS IN TERMS OF HOW
TO BUILD THE MATERNAL
PHARMACOLOGY LANE BUT RIGHT NOW
WE'RE IN THE EARLY STAGES OF
INCLUDING THIS COMPONENT.
>> THANK YOU, LESLY.
>> HELLO.
I'M WITH THE CDC.
IT'S NOT SO MUCH A QUESTION AS A
PLUG.
ONE AVENUE THAT MAY BE
INTERESTING IS THE NATIONAL
SOCIETY OF EPIDEMIOLOGY.
THEY HAVE ANNUAL MEETINGS.
IT SOUNDS LIKE YOUR FELLOWS
COULD REALLY LEARN A LOT THERE
AND IT'D IN GREAT TO SEE YOUR
WORK PRESENTED.
>> THANK YOU.
I'LL MAKE NOTE OF THAT AND SHARE
WITH FELLOWS.
>> THANK YOU.
ALISON.
>> ALISON HAROLD, THESE ARE MY
VIEWS AND NOT THAT OF MY AGENCY
AND IT'S INTERESTING TO HEAR THE
PROGRAM AND REFLECT THE ENERGY
AND EXCITE, YOU BRING TO THE
PROGRAM SO THANK YOU FOR AN
EXCELLENT PRESENTATION.
AS FAR AS YOUR OUTCOMES DATA YOU
PRESENTED INFORMATION TO WHERE
THE FELLOWS ARE GOING
POSTRESEARCH EXPERIENCE BUT HAVE
YOU ALSO LOOKED AT THE
COLLABORATIVE NETWORKS AND
WHETHER THEY'RE MAINTAINED AFTER
FELLOWS GRADUATE FROM THE
PROGRAM?
>> THAT'S A GREAT QUESTION.
WE DO SEE MANY COLLABORATIONS
ARE MAINTAINED BUT I DON'T HAVE
THE PHYSICAL DATA TO SHOW THAT.
I THINK THAT WOULD BE OF
INTEREST -- I'M NOT SURE HOW WE
COULD COLLECT THAT DATA BUT I'LL
MAKE A NOTE OF IT AND SPEAK WITH
OUR LOGISTICAL TEAM AND WORK ON
A WAY OF PULLING THAT DATA IN.
WE HAVE SEVERAL FELLOWS THAT
RECENTLY GRADUATED.
ONE WAS CONNECTED DURING A
POSTDOC AND NOW AN INVESTIGATOR.
TA -- THAT WOULD BE INTERESTING
TO SEE WHICH FELLOWS ARE
CONTINUING COLLABORATION IN ONE
WAY OR ANOTHER.
I'LL MAKE NOTE OF THAT AND TRY
TO FIND A WAY TO COLLECT THAT
DATA AND SHARE.
>> HI, JANET HARDY.
I WANT TO FOLLOW-UP WITH KATIE
SCHUBERT'S QUESTION YOU MENTION
THE MATERNAL PHARMACOLOGY
PROGRAM IS PLANNED AND DO YOU
HAVE A TIME FRAME ON MOVING THAT
FORWARD?
>> HONESTLY I DON'T.
I SAY I DON'T BECAUSE THE
BUILDING OF THE NETWORK IS ONLY
AS STRONG AS THE -- I'M FINDING
THE APPROPRIATE LANGUAGE THE
INVESTIGATOR WHO JOIN THE
NETWORK AND PUSHING TO
INVESTIGATORS TO APPLY WITH A
MATERNAL COMPONENT.
WE NEED PROGRAMS APPLYING WITH
THE MATERNAL COMPONENT AS A PART
OF THEIR PROGRAM.
I'M ENCOURAGING INVESTIGATORS
THAT HAVE AN INTEREST IN
MATERNAL PHARMACOLOGY TO APPLY.
IT'S A WORK IN PROGRESS.
>> I'M A PHYSICIAN SCIENTIST AT
NORTHWESTERN UNIVERSITY AND WITH
REGARDS TO THE EXPANSION IN THE
MATERNAL PHARMACOLOGY PROGRAM I
THINK THE INVESTIGATORS PART OF
THE PHARMACOLOGY RESEARCH UNITS
WOULD BE HIGHLY MOTIVATED TO
APPLY.
I'M AN FMFU P.I. AND I WOULD SAY
KNOWING MANY OF THOSE
INVESTIGATORS IS A GREAT PLACE
TO START WITH PLANNING
LEADERSHIP THOUGH THE UNIT --
>> I MAY TAKE THE CHAIR'S
PREROGATIVE TO ASK THE LAST
QUESTION.
YOU MENTIONED THE INTELLECTUAL
SUPPORT FOR MENTORS.
THE IMPLEMENTATION PLAN CALLED
OUT MENTOR SUPPORT.
CAN YOU TALK ABOUT OTHER
ELEMENTS LIKE PHYSICAL SUPPORT
OF MENTORSHIP WHICH IS
HISTORICALLY RELATIVELY LOW AS
PART OF THE T32s PROGRAMS.
WHAT'S THE VISION OF NIH WITH
RESPECT TO SUPPORTING MENTORS?
>> THAT'S A GREAT QUESTION.
HISTORICALLY AND CURRENTLY IS
LOW AND SOMETHING LEADERSHIP
RECOGNIZE.
AS THE NETWORK GROWS WE
RECOGNIZE THE NEED FOR MORE
SUPPORT TO MAINTAIN THE PROGRAMS
AND ADMINISTRATIVE SUPPORT, MORE
SUPPORT FOR THE P.I. AND NOTICE
IN DISCUSSION BUT NOT SURE AT
WHAT PLACE IT'S AT AT
POTENTIALLY INCREASING SUPPORT.
IT'S A CHALLENGE TO SAY WHAT THE
NEXT STEP IS BECAUSE I THINK
WE'RE STILL IN THE PROCESS OF
TALKING THROUGH AND HAVING A
TRAINING WORK GROUP WHERE WE
NOTED ALL THESE REQUEST FOR
P.I.s ABOUT MORE SUPPORT.
CHANGES TO THE FUNDING AND HOW
FUNDING CAN BE USED.
WE DO RECOGNIZE IT'S SOMETHING
THAT NEEDS TO BE ADDRESSED AND
STILL WORKING THROUGH THAT.
I WANTED TO PUT IN A PLUG NIH
HAS AN RFI, REQUEST FOR
INFORMATION, REGARDING TRAINING.
IF THERE'S ANY SUGGESTIONS YOU
DISCUSS PLEASE SUBMIT TO THE
RFI.
IT ONLY HELPS STRENGTHEN THE
REQUESTS AS IT COMES FROM THE
P.I.s AND COMMUNITY.
>> WE WILL MOVE ON TO OUR NEXT
SPEAKER, RACHEL TEPLA.
>> GOOD MORNING.
I HAVE A COUPLE NOTES HERE.
IT'S GREAT TO BE ABLE TO SPEAK
WEDGE YOU THIS MORNING.
MY NAME IS RACHEL TETLO AT THE
AMERICAN COLLEGE OF OBSTETRICS
AND GYNECOLOGISTS.
YOU'LL SEE MY CREATIVE
PRESENTATION TITLE.
>> CAN WE CONFIRM OUR MEMBERS
ONLINE CAN SEE THE SLIDES?
>> WE CANNOT.
>> IT HAS NICE FORMATTING IF
YOU'D LIKE TO LOOK AT MY LAPTOP
LATER.
I HAVE NO CONFLICTS.
SO I WANTED TO SPEND A LITTLE
BIT OF TIME SHARING ABOUT ACOG
AND HOW WE OPERATE AND GO INTO
SOME OF OUR WORK AROUND THE
RECOMMENDATIONS AND THEN I THINK
WILL FLOW NICELY INTO BECKY'S
PRESENTATION.
ACOG, ALL WE DO COMES BACK TO
OUR MISSION, VISION AND CORE
VALUES AND THIS FITS INTO ALL
THESE THINGS.
AND I'LL SAY MANY KNOW THIS
ALREADY BUT WE HAVE MORE THAN
60,000 MEMBERS AND OUR MEMBERS
ARE OBSTETRICIANS AND
GYNECOLOGISTS WHO ARE ACROSS THE
SPECTRUM IN TERMS OF PRIVATE
PRACTICE, EMPLOYEE PHYSICIANS,
RESEARCHERS AND WE DO NOT DO
RESEARCH OURSELF BUT DO CLINICAL
RECOMMENDATIONS.
OUR GUIDANCE DOES SERVE AS THE
BASELINE FOR OUR ADVOCACY WORK
AND OUR COMMITTEE OPINION ON
CONSIDERATIONS FOR INCLUDING
WOMEN AS RESEARCH PARTICIPANTS
GOES THROUGH A REGULAR REVIEW
PROCESS.
THAT'S AS MUCH AS I CAN SAY AT
THIS POINT BUT A COUPLE THINGS
TO PULL FROM THERE BECAUSE IT
SERVES AS A BASELINE FOR ALL THE
OTHER WORK WE DO IN THE SPACE WE
BELIEVE THE POTENTIAL FOR
PREGNANCY SHOULD NOT MEAN
AUTOMATIC EXCLUSION AND PREGNANT
INDIVIDUALS SHOULD NOT BE
CONSIDERED VULNERABLE AND LOOK
AT THE DATA WHEN IT WAS
PUBLISHED IT WAS BEFORE THE
COMMON RULE WAS UPDATED AND AN
APPRECIATED THE UPDATE WE JUST
GOT YESTERDAY ON THAT AS WELL.
WE SHOULD NOT REQUIRE CONSENT
FROM AN INTIMATE PARTNER AND
IT'S IMPORTANT TO WEIGH THE RISK
AND IMPORTANCE OF INFORMATION TO
BE GAINED.
IT SERVES AS A BASELINE FOR THE
CLINICAL RECOMMENDATIONS WE
SHARE WITH MEMBERS AND THIS IS
ALSO AVAILABLE TO THE PUBLIC AND
ALSO SERVES AS OUR BASELINE FOR
OUR ADVOCACY PRIORITIES AS WELL.
AND SO EVERY YEAR ACOG'S
GOVERNMENT AFFAIRS COMMITTEE
RECOMMENDS AND DIRECTORS APPROVE
OUR ADVOCACY PRIORITIES FOR THE
YEAR UNDER THE FIRST ONE, DIRECT
POLICIES TO PROMOTE SERVICES AND
IMPROVED OUTCOMES IS A SUB
BULLET FOR PREGNANT AND
LACTATING PEOPLE IN RESEARCH AND
THIS SERVES AS THE MEDICAL
BASELINE AND THERE'S NO DAYLIGHT
BETWEEN OUR CLINICAL
RECOMMENDATIONS AND PRIORITIES
AS WELL.
WHAT'S THAT MEAN IN TERMS OF OUR
ROLE HERE IN LOOKING AT NOT ONLY
CLUSTER B BUT ALL THE CLUSTERS
IS ADVOCATE, ADVOCATE, ADVOCATE.
WE DO THAT IN A NUMBER OF
DIFFERENT WAYS.
WE ARE FOUNDING MEMBERS ON THE
STEERING COMMITTEE TO ADVANCE
MATERNAL THERAPEUTICS.
BECKY WILL TALK MORE ABOUT THE
ACTIVITIES OF THE COALITION
CURRENTLY AS IT RELATES TO THESE
RECOMMENDATIONS.
WE'RE MEMBERS OF THE WOMEN'S
FIRST RESEARCH COALITION.
IT ADVOCATES FOR THE BRCH
SCHOLARS PROGRAM AND WE ARE
CHAIR OF THE FRIENDS OF NICHD
AND STANDING MEMBER OF THE
EXECUTIVE COMMITTEE AND TOGETHER
WITH OUR PARTNERS FOR MATERNAL
THERAPEUTICS, ACOG WAS KEY IN
DRAFTING THE ORIGINAL SAFE
MEDICATIONS FOR MOMS AND BABIES
ACT THAT FORMED PRGLAC AND
CONTINUED TO ACTIVELY ADVOCATE
FOR THE NEXT ITERATION INCLUDING
A NUMBER OF PRGLAC
RECOMMENDATIONS AS WELL.
WE HAD LAST YEAR IN 2023, WE HAD
NEARLY 700 MEMBERS ON CAPITOL
HILL ADVOCATING AND CONTINUING
AWARENESS ON THAT.
WHEN WE THINK OF THE SPECIFICS
AND THERE WERE NUMBERS, 3, 5 AND
6 HERE, FOR THIS PARTICULAR
CLUSTER AND OUR ROLE I WAS
REFLECTING ON WHERE WE HAVE BEEN
OVER THE PAST FEW YEARS.
I KNOW I KIND OF TALKED WITH
THIS BEFORE AND MANY OF US HAVE
ABOUT HOW THE TIMING OF THE
INITIAL RECOMMENDATIONS AND THE
IMPLEMENTATION PLAN WERE THE
INITIAL RECOMMENDATIONS CAME OUT
IN 2018.
AND IMPLEMENTATION IN 2020 AND
WE HAD AT THAT TIME PUTTING
THESE TO THE TEST OR AT LEAST
THE OPPORTUNITY TO SEE IN REAL
TIME WHY THIS IS SO IMPORTANT
AND TO REITERATE WHY THE WORK OF
PRGLAC IS SO IMPORTANT.
IN TALKING ABOUT THE EXCLUSION
OF PREGNANT INDIVIDUALS FROM THE
INITIAL COVID VACCINE TRIALS
DESPITE ADVOCACY FROM MANY IN
THIS ROOM AND BEYOND THAT DID
DEMONSTRATE IN REAL TIME HOW THE
BARRIERS TO THIS RESEARCH AND IT
CAUSED HARM AND CONTRIBUTED TO
AVOIDABLE LOSS OF LIFE.
AND THAT CONTINUES TO DRIVE, I
THINK, SO MUCH OF THE WORK WE DO
IN THE ADVOCACY SPACE AT ACOG AS
WELL AS THE CLINICAL SIDE AS
WELL.
AND IT'S REALLY CHALLENGING FOR
US TO SEPARATE OUT THESE
RECOMMENDATIONS AND THE CLUSTER
FROM THE REST OF THE
RECOMMENDATIONS WITHOUT FURTHER
INCLUSION AND INTEGRATION INTO
DIFFERENT RESEARCH AGENDA
RECOMMENDATION 1 WITHOUT AN
INCREASE IN THE TIMELINESS
WITHOUT THE REMOVAL OF
REGULATORY BARRIERS AND
MITIGATING LIABILITY CONCERNS WE
WON'T BE SUCCESSFUL IN THE OTHER
PIECE TOO.
OUR WORK AND FOCUS WILL BE
CONTINUING TO ADVOCATE AS MUCH
AS POSSIBLE THROUGH ALL THE
DIFFERENT ASPECTS OF IT.
AND I DID WANT TO RAISE AS WELL
WE WERE EXCITED ABOUT THE
EXECUTIVE ORDER SIGNED EARLIER
THIS WEEK.
THERE WERE A LOT OF ASPECTS TO
IT AND WE'RE EXCITED TO SEE WHAT
HAPPENS NEXT.
ONE PIECE IN PARTICULAR I THINK
GOES TO RECOMMENDATION THREE
INCLUDED A COMMITMENT TO EXPAND
TRAINING WOMEN'S HEALTH WITH
COLLABORATION WITH THE CDC
FOUNDATION AND AMERICAN BOARD OF
OBSTETRICS AND GYNECOLOGY AND
WARE EXCITE ABOUT THAT AND LOOK
FORWARD TO KEEPING A CLOSE EYE
AND FOLLOWING THAT
IMPLEMENTATION WITH INTEREST AND
ENTHUSIASM.
I'M HAPPY TO ANY QUESTIONS BUT
WANTED TO SHARE THAT BASELINE OF
OUR FOCUS AND WHAT WE FEEL IS
OUR CURRENT ROLE IN THE SPACE
AND I LOOK FORWARD TO QUESTIONS.
THANK YOU VERY MUCH.
>> THANK YOU VERY MUCH, RACHEL.
WE HAVE ABOUT 11 MINUTES FOR
CLARIFYING QUESTIONS IF WE HAVE
ANY AND PERHAPS IF WE CAN SEE
OUR PARTNERS ONLINE.
CHRISTINA, PLEASE.
>> CHRISTINA BUCCI-RECHTWEG
THANK YOU FOR PROVIDING THE VIEW
FROM THE ADVOCACY SPACE.
ARE YOU ABLE TO TALK ABOUT THE
EDUCATION AND TRAINING COMPONENT
FOR THE FELLOWS OF THE FUTURE OR
WORKFORCE IN TRAINING AND HOW
RESEARCH AND RESEARCH CORE
CURRICULUM IS BEING BUILT INTO
THE CORE TRAINING?
THANK YOU.
>> THANKS.
I DON'T KNOW IF I HAVE ANYTHING
SPECIFIC TO SHARE AND WE WORK
WITH ACGME AND WITH CREOG AS
WELL.
I'M NOT SURE IF I CAN SPEAK
SPECIFICALLY TO WORK TO BUILD
THAT RESEARCH COMPONENT.
ONE THING I WILL SAY WHICH IS
MAYBE MORE HIGH LEVEL AND PULLED
BACK BUT I THINK IT'S
CHALLENGING TO LOOK AT THE
FUTURE OF THE PROFESSION WITHOUT
THINKING OF THE CHALLENGES OF
THE CURRENT LANDSCAPE FOLKS ARE
DEALING WITH AS THEY'RE
CONSIDERING WHETHER OR NOT TO GO
INTO OB-GYN AT ALL AND WHERE
THEY WANT TO PRACTICE.
I THINK WE HAVE A LOT OF
CONSIDERATION TO THINK THROUGH
THE FUTURE OF THE PROFESSION AND
IMPACTS OF STATE LAWS
RESTRICTING THE COMPREHENSIVE
PRACTICE OF OB-GYN THAT I THINK
IS GOING TO HAVE POTENTIALLY AN
ALARMING IMPACT ON THE FUTURE OF
THE PROFESSION INCLUDING THE
RESEARCH SPACE.
NOT TO GO TOO FAR DOWN THAT PATH
BUT THE RECENT SUPREME COURT
DECISION OUT OF ALABAMA THAT
CONFERRED PERSONHOOD ON AN EM
EMBRYO HAS SCARY IMPLICATIONS
FOR RESEARCH AND THERAPEUTIC
HUSE DURING PREGNANCY AND HEARD
CONCERNS FROM OUR MEMBERS WHAT
THIS COULD MEAN IN TERMS OF
POTENTIAL HARM TO A PREGNANCY
THAT MAY OR MAY NOT HAVE BEEN
CONTRIBUTED BY THE USE OF
THERAPEUTICS DURING PREGNANCY
WHETHER MEDICATIONS FOR OPIOID
USE DISORDER, FOR MENTAL HEALTH
CONDITIONS, OTHER CONDITIONS.
I KNOW IT'S NOT EXACTLY YOUR
QUESTION BUT THERE ARE A LOT OF
CHALLENGING CONSIDERATIONS FOLKS
ARE GRAPPLING WITH IN TERMS OF
THE FUTURE AND RESEARCH.
>> CAN YOU EXPAND OR CLARIFY
MORE ON YOUR COMMUNICATION
INITIATIVES OUTSIDE THE ADVOCACY
TOWARDS LEGISLATORS IS MOST
COMMUNICATION INTERNALLY
DIRECTED TO MEMBERS OF THE
COLLEGE OR COMMUNICATION
CONSTRUCTED FOR THE GENERAL
PUBLIC?
>> OUR PRIMARY COMMUNICATION IS
TO OUR MEMBERS IN TERMS OF
GETTING THE WORD OUT ABOUT
RECOMMENDATIONS AND THE
REGULATORY SPACE PRIMARILY OUR
COMMITMENT AND OBLIGATION IS TO
OUR MEMBERS TO COMMUNICATE THAT
OUT.
WE CERTAINLY DO USE PUBLIC
CHANNELS WHEN POSSIBLE BUT OUR
PRIMARY TARGET IS TO MEMBERS.
>> WE HAVE A QUESTION FROM
SHARON ONLINE.
>> THANK YOU FOR THAT
INTERESTING PRESENTATION.
EVERY PEDIATRIC PROGRAM OUT
THERE HAS ADVOCACY AS PART OF
THE ELECTIVE.
IS THERE TWINNING ACROSS
PEDIATRIC AND OB TO USE SOME OF
THAT ADVOCACY SPACE TRAINING ON
THE PEDIATRIC SIDE TO LEND
ITSELF TO I WANT TO SAY WORKING
THROUGH SOME OB ISSUES AS WELL?
>> OBSTETRICS AND GYNECOLOGY
ALSO HAS AN ADVOCACY COMPONENT
BAKED INTO THE RESIDENCY
TRAINING.
WHAT THAT LOOKS LIKE IS
DIFFERENT AT EACH PROGRAM.
I THINK THERE PROBABLY IS QUITE
A BIT OF OPPORTUNITY THERE AND
I'M NOT SURE THAT'S BEEN TAKEN
ADVANTAGE OF YET BUT THANK YOU
FOR POINTING THAT OUT.
I'M HAPPY TO BRING THAT BACK TO
FOLKS AS WELL.
>> THIS QUESTION IS FROM MY HAT
AS AN ENDOCRINOLOGIST AND WHAT
IS ADVOCACY ENCOMPASS FOR THE
TRAINING?
>> I'VE BEEN WITH ACOG ALMOST 12
YEARS AND I BELIEVE IT WAS ADDED
ABOUT A DECADE AGO AND I THINK
IT'S BEEN ABOUT IN THE LAST
DECADE OR SO.
IT IS FAIRLY NEW.
I THINK THE CURRICULUM LOOKS A
BIT DIFFERENT AT EACH
INSTITUTION.
THERE'S BEEN SOME OF ACOG'S
JUNIOR FELLOWS THE YOUNGER
PHYSICIANS INCREDIBLY
ENTHUSIASTIC AND CREATED
CURRICULUMS THAT EXPANDED TO
OTHER PROGRAMS BUT EACH PROGRAM
LOOKS A LITTLE BIT DIFFERENT IN
TERMS OF THE SPECIFIC
CURRICULUM.
>> ANY FINAL QUESTIONS FOR
RACHEL?
THANK YOU.
WE'LL GO ON THEN TO REBECCA THE
SENIOR DIRECTOR OF ADVOCACY FOR
SMFM.
>> GOOD MORNING.
I'M EXCITED ABOUT TODAY'S
PRESENTATION AND THERE'S
RACHEL'S PRETTY PRESENTATION.
SO BEAUTIFUL, GUYS, LOOK AT IT.
UGH.
IT'S BEAUTIFUL I'M BECKY ABBOT,
I'M AN ADVOCATE FOR THE SOCIETY
OF MATERNAL-FETAL MEDICINE AND
SERVE AS THE CHAIR OF THE
COLLISION TO ADVANCE MATERNAL
THERAPEUTICS RACHEL TALKED A
LITTLE BIT ABOUT.
IT'S BEEN AROUND TWO YEARS AND
FOCUSSED ON CHANGING THE CULTURE
WITHIN RESEARCH TO INCLUDE
PREGNANT FOLKS IN RESEARCH AND
WE WOULD LIKE TO NOT BEING DOING
IT IN 10 MORE YEARS BUT WE'RE
DEDICATED TO THE CAUSE.
WE'LL BE TALKING A BIT FROM MY
ROLE AS SMFM AND THE COALITION'S
WORK AS WELL.
A LITTLE BIT ABOUT THE SOCIETY.
WE'RE A MEMBERSHIP ORGANIZATION.
WE HAVE OVER 7,000 MEMBERS.
WE'RE A SUBSPECIALTY.
MANY OF OUR MEMBERS ARE ALSO
MEMBERS OF ACOG BUT WE HAVE
SPECIAL INTERESTS WE DEAL WITH
AT OUR SOCIETY AS WELL.
THIS ISSUE IS A PARTICULAR
CONCERN DUE TO THE PATIENT
POPULATION THEY CARE FOR AND THE
SMFMs GET AN ADDITIONAL TIME OF
TRAINING CARING FOR FOLKS WITH
PREGNA
PREGNANCIES.
WHILE THE EXISTENCE OF A
PREEXISTING CONDITION PUTS
PATIENTS AT GREATER RISK AND
OFTEN BENEFIT FROM THE CARE
THROUGH DIRECT CARE OR WITH
THEIR MATERNAL CARE PROVIDER.
PREGNANT WOMEN ALSO GET SICK.
YOU ALL KNOW THIS WELL.
THEY MIGHT DEVELOP A PREGNANCY
THAT THREATENS THE HEALTH OF
THEIR BABY OR THEMSELVES.
THE COMMON THREAD IS THESE WOMEN
WILL NEEDS THERAPEUTICS DURING
THE COURSE OF THEIR PREGNANCY
AND OUR MEMBERS ARE RESPONSIBLE
FOR COUNSELLING PATIENTS ON THE
SAFETY AN EFFICACY ON THE
MEDICINE WITH LITTLE OR NO DATA
AND WE'VE BEEN XITCOMMITTED TO S
BECAUSE IT'S IMPORTANT TO THE
PATIENTS WE SERVE.
THAT'S WHO WE ARE AND WHY WE DO
THE WORK.
AND I'VE BEEN ASKED TO TALK
ABOUT SOME RECOMMENDATIONS 3 AND
I'LL MOVE NA 5 AND 6 AS WELL.
BEFORE WE DO THAT, I WORK WITH
POLITICIANS EVERY DAY SO I KNOW
WHAT I WANT TO TALK ABOUT FIRST
BUT I PROMISE I'LL GET TO WHAT I
WAS ASKED TO TALK ABOUT.
I WANT TO TELL YOU ABOUT THE
COALITION TO ADVANCE MATERNAL
THERAPEUTICS AND WHAT WE'VE BEEN
UP TO.
WE HAVE ABOUT FIVE PRIORITIES
AND PURSUE THESE VIGOROUSLY
THROUGH EVERY AVENUE WE HAVE
AVAILABLE TO US.
THAT'S THROUGH DIRECT LOBBYING
OF AGENCIES AND AUTHORIZATION
LEGISLATION AND HAVE BEEN
SUCCESSFUL IN THE APPROPRIATIONS
PROCESS.
I WANT TO GIVE A HUGE THANKS TO
ACOG, SWHR AND MARCH OF DIMES
WHO ARE ALSO ON THE STEERING
COMMITTEE AND PARTNERS IN THE
WORK.
THE FIRST RECOMMENDATION WE
HEARD AT THE LAST MEETING WE
WANT THE FOOD AND DRUG
ADMINISTRATION TO DATE THEIR
REGULATION TO REMOVE PREGNANT
PEOPLE AS A VULNERABLE RESEARCH
POPULATION.
WE RECOGNIZE ALIGNING FDA
REGULATIONS WITH THE COMMON RULE
SAY LARGE UNDERTAKING BUT WE ARE
COMMITTED AND ANNOYING ABOUT
THIS AND WE'LL CONTINUE TO BE
UNTIL THE CHANGE IS MAIN SO
APOLOGIES AT FDA BUT WE WOULD
LOVE TO DO THIS AS SOON AS
POSSIBLE.
THE TWO NEXT ARE CONNECTED BUT
SEPARATE.
WE WOULD LOVE TO ESTABLISH HOW
THE INFORMATION ON CLINICAL
TRIALS AND REGISTRIES AND
PREGNANT AND LACTATING PEOPLE WE
KNOW THERE ARE NUMEROUS SITES,
CLINICAL TRIALS.gov AND FDA HAS
ITS ONLINE PORTAL AND ONE MAIN
BARRIER OUR MEMBERS TALK ABOUT
WHEN THEY TALK ABOUT WHETHER
THEY'LL OFFER UP TO THEIR
PATIENTS ENROLLMENT IN CLINICAL
TRIAL OR REGISTRIES IS THEY
DON'T KNOW THEY EXIST AN IT'S
HARD IT DO.
WHILE OUR PARTNERS MAINTAIN THIS
INFORMATION WE'D LIKE IT TO BE A
ONE STOP SHOT AND WE GET
PUSHBACK FROM TIME TO TIME BUT
WE'RE TENACIOUS AND IT ALIGNS
WITH RECOMMENDATIONS 6 AND 13.
WE'RE ALSO ADVOCATING TO CREATE
AN EDUCATION CAMPAIGN TARGETED
TO CONSUMERS AND CLINICIANS ON
ENROLLING PREGNANT AND LACTATING
PEOPLE IN CLINICAL TRIALS WE
WROTE THIS IN OUR LEGISLATION
AND FOCUSSED ON PROVIDING
CLINICIANS WITH TOOLS TO HAVE
THE HARD CONVERSATIONS AND THEN
ALSO HELPING FOLKS UNDERSTAND
PREGNANT PEOPLE AND THEIR
FAMILIES UNDERSTAND THE RISKS OF
ENROLLMENT AND BENEFITS AND
UNDERSTANDING IT BETTER IN THE
PROCESS.
SOME TOOLS OUR CLINICIANS CAN BE
SENT OUT IN THE WORLD TO USE IN
THEIR PRACTICES.
THAT'S TREMENDOUSLY IMPORTANT.
WE WANT TO INITIATE NEW CLINICAL
RESEARCH AT THE NATIONAL
INSTITUTE OF HEALTH ON INSISTING
NEW MEDICATION.
SIMILAR TO PPCA BUT FOR PREGNANT
AND LACTATING WOMEN.
AND WE CONTINUE TO ADVOCATE FOR
MONEY FOR THIS GROUP TO MONITOR
PROGRESS ON THE 15
RECOMMENDATIONS AND THE
SUBSEQUENT IMPLEMENTATION PLAN.
WE WERE EXCITED TO HAVE $200,000
IN FISCAL YEAR 2023.
PERHAPS WE'LL HAVE ANOTHER
$200,000 TO DO THIS WORK THIS
YEAR I NO WE'RE LIVING ON
BORROWED MONEY UNTIL CONGRESS
TAKES ACTION TODAY OR NOT.
WE'LL SEE.
AND WE'RE ADVOCATING FOR THAT IN
FISCAL '25 AND WILL CONTINUE TO
ADVOCATE FOR IT.
AS YOU LOOK AT THE LANGUAGE THE
CHAIRS PUT UP AT THE BEGINNING
OF THE MEETING EVERY TIME IF YOU
WANT THAT LANGUAGE TO BE
DIFFERENT WE'D LOVE TO HEAR FROM
YOU.
I WILL QUICKLY TALK ABOUT
ANOTHER THING NOT ON THE LIST
TODAY AND ONE THING WE'RE
EXCITED TO DO AT THE SOCIETY IS
OUR MEMBERS ARE OFTEN DUE TO
THEIR TRAINING AND WHERE THEY
WORK AFTER TRAINING, ARE OFTEN
TIMES CLINICIAN RESEARCHERS.
I WANT TO USE THAT PULPIT AND
PLACE OF INFLUENCE TO START
THINKING ABOUT EDUCATING
INSTITUTIONS AND INSTITUTIONAL
IRBs ABOUT INCLUSION TO PREGNANT
AND LACTATING WOMEN IN RESEARCH.
WE'RE DEVELOP TOOLKIT.
WE HAVEN'T STARTED YET, IT'S
JUST AN IDEA, BUT WE'LL GET IT
DONE FOR OUR FOLKS TO GO OUT AND
TALK TO THEIR IRBs AND
INSTITUTIONS ABOUT HOW THEY
SHOULD INCLUDE PREGNANT AND
LACTATING WOMEN IN STUDY
DESIGNS, WHAT IT LOOKS HIKE AND
WHAT PROTECTIONS ARE AND WHY
IT'S IMPORTANT.
WE'LL ENCOURAGE THEM TO INCLUDE
MFMs AND WE THINK IT'S SOMETHING
IS WE CAN HELP OUT IN THE RECORD
REPORT.
I'LL DIVE INTO THINGS WE'RE
TALKING ABOUT TODAY EXCITED TO I
HAVE THIS CONVERSATION ABOUT 3
AND APPRECIATE THE UPDATE WE
JUST HAD FROM DR. BATES ABOUT
THE WORK NICHD IS DOING.
TO RACHEL'S POINT IT'S HELPFUL
EXAMPLE OUT AND RECOGNIZE THE
CHALLENGES AND OPPORTUNITIES IN
RECOMMENDATION 3 ARE NOT
SPECIFIC TO OBSTETRIC AND
LACTATION PHARMACOLOGY BUT TRUE
FOR OB-GYN CLINICIAN SCIENTISTS
GENERALLY.
WE NEED AND NEED TO THINK OF
TRAINEES AND EARLY CAREER
INVESTIGATORS AND INVEST IN OUR
NETWORKS AND CREATE NEW ONES.
SFMF PARTICIPATES IN THE AD
HUMAN BEING FOR MEDICAL RESEARCH
FOCUSSED ON GETTING MORE MONEY
FOR NIH AND THE WORK THROUGH
WOMEN FIRST RESEARCH COALITION
TO TRY TO GET AS MUCH AS THE NEW
MONEY DEDICATED TO OB-GYN
RESEARCH.
SO, WE APPRECIATE THE WORK NICHD
HAS DONE WITH US AND LOOK
FORWARD TO CONTINUING THE
CONVERSATIONS.
IT WOULD BE HARD TO ADDRESS SOME
OF THE ISSUES WITHOUT LOOKING AT
THE OB-GYN CLINICIAN SCIENTIST
LANDSCAPE WRIT LARGE.
I WANT TO SAY WE WERE
SPECIFICALLY CALLED OUT I DID A
CONTROL FIND BEFORE I CAME TODAY
AND INCREASING AWARENESS OF
CAREER OPPORTUNITIES THROUGH
RECRUITMENT AND AWARENESS AT
PROFESSIONAL SOCIETY MEETINGS.
WE'RE HAPPY TO DO THIS AND WE
THINK DR. BATES I THINK YOU HAVE
MORE INFORMATION AND WE HAVE THE
OPPORTUNITY THROUGH OUR ANNUAL
MEETING AND OUR INTERACTIONS
WITH FELLOWS AND THROUGH OUR
TRAINEE DIRECTORS TO THINK HOW
WE MIGHT ABLE TO SHARE THOSE
OPPORTUNITIES AND LOOK FORWARD
TO PARTNERING WITH YOU ON THAT.
THE OTHER THING I WANTED TO TALK
ABOUT IS RECOMMENDATION 6.
IT FOCUSES ON HELPING PROVIDERS
COMMUNICATE ON ENROLLMENT UP
TRIALS AND REGISTRIES.
THIS IS IMPORTANT.
I THINK WE HEAR FROM OUR
CLINICIANS OFTEN HOW THESE ARE
DIFFICULT CONVERSATIONS TO HAVE.
THESE ARE DIFFICULT THINGS TO DO
WITHOUT THE RESOURCES.
NEXT PRESENTATION WILL DIVE INTO
THIS MORE BUT WANT TO LIFT UP
THE WORK WE'RE DOING THROUGH THE
COLLISION TO ADVANCE MATERNAL
THERAPEUTICS TO CREATE THE
ONLINE HUB AND EDUCATION
CAMPAIGN.
BRIEFLY WE'LL RUN THROUGH WHERE
THE TWO PIECES OF THE ADVOCACY
WORK COULD BE HELPFUL THINKING
ABOUT 6A AND THE TWO-WAY
COMMUNICATION, INCREASING HEALTH
PROVIDER'S AWARENESS WILL BE
HELPFUL FOR THAT AND ALL OF 6B
WOULD BENEFIT FROM THIS ONLINE
HUB WITH THE EDUCATION CAMPAIGN
INCORPORATED AND THEN WHENEVER
WE THINK ABOUT 6C, 6CA THAT'S
WHAT WE WANT THIS READILY
ACCESSIBLE WEBSITE TO INCREASE
AWARENESS OF CLINICAL RESEARCH
OPPORTUNITIES.
WE LOOK FORWARD TO CONTINUING
THE ADVOCACY AND WORKING WITH
THE GROUP IN WHAT MIGHT BE ON
THE WEBSITE.
I THINK THERE ARE OPPORTUNITIES
FOR SFMF ONCE WE GET FURTHER
DOWN THE ROAD TO INCORPORATE
SOME OF THESE PIECES AND
CONTINUING MEDICAL EDUCATION
WHETHER ONLINE OR IN OUR
MEETINGS.
I LOOK FORWARD TO THAT AS WELL.
I DO WANT TO CHALLENGE THIS
GROUP AS WE MOVE FORWARD TO
THINK THROUGH IN RECOMMENDATIONS
HOW WE PUT FORWARD ACTIONABLE
THINGS AND IF THERE'S
RECOMMENDATIONS YOU HAVE FOR
SOCIETY TO PULL THOSE OUT AND I
CAN TAKE THEM BACK HERE AND IN
THE REPORT.
I APPRECIATE THE TIME AND I
WANTED TO SAY THANK YOU FOR
OFFERING YOUR TIME AND EXPERTISE
TO THE WORK.
IT'S SO IMPORTANT AND WE'RE SO
THANKFUL TO YOU.
HAPPY TO ANSWER ANY QUESTIONS.
>> THANK YOU, VERY MUCH, BECKY.
WE'VE GOT ABOUT 10 MINUTES FOR
CLARIFYING QUESTIONS FOR BECKY.
I'LL GET STARTED.
YOU TALKED ABOUT THE GOAL OF
THE COALITION TO ESTABLISH THE
WEBSITE, DO YOU HAVE A BUSINESS
PLAN FOR THAT ALREADY?
>> WE DO HAVE A BUSINESS PLAN.
I CAN FOLLOW-UP WITH THE EXACT
LANGUAGE BUT WE TALKED ABOUT
PROVIDER AND PATIENT-FACING
EDUCATION AND COUNSELING TOOLS
NEED
NEEDED AND INCORPORATING MANY
FOLKS AROUND THE ROOM OR
ORGANIZATIONS AND EXPERTISE.
WE'RE CURRENTLY IN THE CURRENT
APPROPRIATIONS PROCESS.
I WILL NOTE IT WILL BE UNDER
FUNDED IF THEY PASS THIS.
I THINK WE HAVE A MILLION
DOLLARS WE'RE ASKING FORTHIS
YEAR AND WE KNOW IT'S NOT ENOUGH
BUT ALSO KNOW IT'S A TIGHT
FISCAL YEAR SO WE LOOK FORWARD
TO -- WE'RE HOPEFUL THAT IS
INCLUDED IN FISCAL '25 PACKAGE
AND MAYBE WE CAN START WITH THE
DOWN PAYMENT.
>> AND THE REALIST GOAL FOR A
LAUNCH DATE WOULD BE?
>> WE'D HAVE TO PASS IT FIRST.
>> I THINK THERE'S THINGS WE CAN
DO AT THE AGENCY IN THE INTERIM
BUT I KNOW THEY HAVE OTHER
PRIORITIES.
I THINK WE'RE TRYING DO WHAT WE
CAN ON THE APPROPRIATIONS.
>> OTHER QUESTIONS FOR BECKY?
>> THANK YOU BOTH AND TO
DR. BATES FOR THE PRESENTATION.
MY QUESTION IS BOTH FOR RACHEL
AND FOR REBECCA WHICH IS I THINK
BOTH OF YOU COMMENTED PERHAPS ON
THE OB-GYN PHYSICIAN SCIENTIST
WORKFORCE AND SOME OF THE LARGER
LANDSCAPE CHALLENGES.
I SUPPOSE I'M CURIOUS ABOUT
STRATEGIES TO ADDRESS THAT IN
BOTH SOCIETIES AND SECONDARILY
I'M CURIOUS IN TERMS OF OUR
TOPIC TODAY AND TRAINING
PROGRAMS ABOUT RETENTION
STRATEGIES AROUND ANY MUCH THE K
OR T PROGRAMS ESPECIALLY IN
REGARDS TO SCHOLARS OR
NON-INSTITUTIONAL SCHOLARS IF
ANY GROUPS HAVE LOOKED AT THAT.
THANK YOU.
>> I THINK WHAT WE'VE TRIED DO
IS WE'RE ALL PART OF THE WOMEN
FIRST RESEARCH COALITION WHICH
INVOLVES ALL THE SUB SPECIALTY
SOCIETIES.
AND THEY DIVE IN DEEM TO THE
NITTY-GRITTY OF THE TYPES OF
AWARDS AND FUNDING MECHANISMS
FOR TRAINEES.
SO THAT IS BOTH OUR TIME AND
FINANCIAL COMMITMENT TO THAT AND
WE CONTINUE TO DO THAT WORK.
I THINK THAT WILL BE MY FIRST
PART OF THE ANSWER.
DO YOU HAVE ANYTHING TO ADD?
>> SURE.
THAT'S PROBABLY THE BIGGEST
THING AND I AND THERE'S BEEN
WORK DONE TO LOOK AT WHEN AND
WHY FOLKS TRANSITION AWAY.
AND THERE'S BEEN A CHALLENGE IN
PROTECTED TIME FOR THE
CONTINUING IN THE PRACTICE AND
ESPECIALLY THOSE EMPLOYED AND
HAVE TO MEET A QUOTA IN THEIR
CLINICAL RESPONSIBILITIES IT
ENDS UP TAKING TIME FROM THE
ABILITY TO DO RESEARCH.
IT HAS A DOWN STREAM IMPACT OF
MAKING IT CHALLENGING TO SERVE
ON THE DIFFERENT GROUPS
THROUGHOUT THE REVIEW PROCESS
FOR GRANTS AS WELL.
AGAIN, THAT'S ANECDOTAL AND I
DON'T THINK THERE'S BEEN A
RECENT REVIEW BUT I HEARD THAT
HISTORICALLY.
IN TERMS OF KEEPING THE BROADER
QUESTION I KNOW THAT WE HAVE
DONE WORK ON TRYING TO COMBAT
BURNOUT WHICH AGAIN MAYBE IS A
LITTLE BIT TOO PULLED BACK BUT I
THINK IS RELATED.
AND THAT WORK IS ONGOING AND I
DON'T KNOW IT'S BEEN MEASURED AT
THIS POINT.
I ACTUALLY REALIZE I ANSWERED
YOUR QUESTION I THINK WRONG
EARLIER ABOUT OUR PRIMARY
TARGET.
WE HAVE A PATIENT-FACING WEBSITE
RELATIVELY NEWER AND STILL BE
BEEFED UP BUT THAT WAS AN
INCORRECT RESPONSE, MY APOL
APOLOGIES.
AND WE HAVE INCLUDED INFORMATION
PARTICULARLY AROUND COVID
VACCINATION DURING PREGNANCY AND
LIFTING UP THE QUALITY OF THE
RESEARCH AND SCIENCE BEHIND IT.
>> A LOT OF THE ENTITIES THAT
RACHEL AND BECKY YOU ALL WERE
REFERENCING THE COALITIONS AND
THE REPRESENTATION FROM THE
SUBSPECIALTIES, I THINK GUESS
THE QUESTION IS ARE YOU ACTIVELY
ENGAGING PATIENT GROUPS THAT
THEMSELVES ARE DRIVING
REGISTRIES AND ADVANCING
RESEARCH IN THEIR AREAS?
BECAUSE I THE HISTORICALLY IF
PEOPLE THINK ABOUT INCLUDING
PATIENTS THEY'RE THINKING OF THE
PERSPECTIVE OF UNDERSTANDING
THEIR STORIES AND LIVED
EXPERIENCES BUT IN REALITY MANY
ARE RUNNING ORGANIZATIONS DEEPLY
INVOLVED IN RESEARCH AND BRING
REGISTRIES AND A DEEPER
KNOWLEDGE OF THE TOPIC AND COULD
CONTRIBUTE TO CONVERSATIONS
ABOUT HOW DO WE ADVANCE RESEARCH
IN THAT AREA AND HOW DO WE
BREAKTHROUGH SOME BARRIERS THAT
WE'RE ADDRESSING.
THE QUESTION IS ARE YOU DOING IT
AND IF YOU'RE NOT, I GUESS IT'S
A RECOMMENDATION THAT WE
CONSIDER INCLUDING SOME OF THE
MORE RESEARCH SOPHISTICATED
PATIENT ORGANIZATIONS.
>> I THINK THE SHORT ANSWER IS
YES.
WE HAVE RECOMMENDATION ON SOME
OF THE GROUPS MENTIONED.
AT LEAST FOR THE FRIENDS OF
NICHD WE CERTAINLY HAVE WORK
WITH THE AMERICAN GYNECOLOGICAL
SOCIETY AND THIS IS -- THAT'S
THE ONE EXCEPTION BUT THE REST
MAKE A CONCERTED EFFORT.
>> TINA CHAMBERS, UC SAN DIEGO
FOR RACHEL AND BECKY, YOU
MENTIONED YOU LOOKED AT
CLINICIANS ALREADY PRACTICING
AND LOOK AT BURNOUT OR REASONS
NORT PROTECTED TIME.
DO YOU HAVE A SENSE PEOPLE
COMING OUT OF RESIDENCY OR
FELLOWSHIP COULD THEY CHOOSE NOT
TO GO A CLINICAL RESEARCH
PATHWAY AND WHY THEY DON'T AND
HAS THIS CHANGED WITH THE LEGAL
LANDSCAPE CHANGING?
IN OTHER WORDS, WHO AVOIDS IT
FROM THE GET GO.
>> CAN I PHONE A FRIEND?
>> I THINK WHILE THERE MAY NOT
BE A LARGE BODY OF RESEARCH WE
HAVE A GOOD UNDERSTANDING WHY
PEOPLE DON'T GO INTO RESEARCH A
NUMBER OF REASONS.
LIMITED FUNDING FOR PEOPLE WHO
ARE ESTABLISHED RESEARCHERS TO
HAVE PROTECTED TIME OUTSIDE THE
PROGRAMS.
CHALLENGES WITH INADEQUATE FUND
FROM THE NICHD TO GET K23s AND
K08s AND K01s AND MAKE IT HARD
TO GET THAT RIGHT OFF THE BAT
AND NEED A BRIDGE AS A FACULTY
MEMBER AND Ks ARE ESPECIALLY
HARD TO GET AND I THINK THERE'S
A LOT OF DISINCENTIVES BECAUSE
OF COMPENSATION STRUCTURES IN
OUR FIELD.
WHEN YOU PUT ALL THOSE TOGETHER
THOUGH MAYBE IT'S NOT STUDIED IN
THE ACADEMIC SENSE IT'S WELL
KNOWN OB-GYN'S FINISHING
FELLOWSHIP INCLUDING GENERALISTS
OR SPECIALISTS FINISHING
RESIDENCY ARE HEAVILY
DISINCENTIVIZED UNLESS THEY'RE
STRONGLY MOTIVATED BECAUSE OF
TIME FOR GETTING FUNDING AND WE
NEED TO GET THESE IN WRITING AND
PRESENT THEM TO NICHD FOR THE
PROGRAMS.
>> THANK YOU.
THAT'S EXACTLY WHAT I THOUGHT
YOU WOULD SAY.
AND THEN YOUR SENSE THAT THIS
HAS GOTTEN WORSE OR CHANGED?
>> ABSOLUTELY.
THE HARDER IT IS TO GET FUNDING,
THE HARDER IT IS FOR PEOPLE TO
TRANSITION TO PROGRAMS.
THE SHRINKING K12 PROGRAMS, THE
MASSIVE CHANGES IN PAY OPPOSED
TO PAY COMPENSATION PLANS HAVE
CHANGED OUR FIELD AND WORRY
ABOUT THE NEXT GENERATION OF
PHYSICIAN SCIENTISTS AND SEE FEW
WHO WANT TO TAKE ON THE
ENVIRONMENT.
>> I'LL MOVE US ON.
DO WE HAVE A QUESTION ONLINE?
>> MY QUESTION IS AGAIN A LITTLE
BIT FOR BOTH OF YOU BUT
PREDOMINANTLY FOR SFMF AND WHAT
ARE WE DOING AS ORGANIZATION TO
CONTINUE PROGRAMS INCLUDING
LACTATION OPPOSED TO THE
OBSTETRICIAN DELIVERED THE BABY
AND ARE OUT OF THIS AND LEAVES
LACTATION IN A PRECARIOUS
SITUATION.
WHERE THE RESEARCH DOESN'T
CONTINUE THROUGH THAT COMPONENT
OF CHILDBEARING.
THANK YOU.
I CAN TAKE THAT BACK AND THINK
THROUGH WHAT WE CAN DO AS A
SOCIETY ORGANIZATIONAL OR ADDING
TO OUR ADVOCACY AND THINKING HOW
TO SUPPORT THE LATE POSTPARTUM
PERIOD INCLUDING RESEARCH ON
LACTATION AND BREAST FEEDING.
THANK YOU.
>> THINGS LIKE REGISTRIES AND
YOU MENTIONED THE WEB PAGE AND
REGISTRY LISTING AND HAVE DONE
PAID ADVERTISING BUT TO YOUR
POINT THERE NEEDS TO BE A
CENTRAL ENTITY THAT PULLS THAT
TOGETHER AND HAVE YOU THOUGHT OF
GETTING INTO THE COMMUNITIES
WHERE WE SEE PATIENTS ON CHRONIC
CONDITIONS WHO WILL BE ON
MEDICATIONS ANYWAY AND THERE MAY
BE OPPORTUNITIES FOR
DISEASE-BASED OR DRUG-BASED
REGISTRIES?
NOT HAVING A CLEAR WAY TO GET
INFORMATION BACK AND THERE'S
BEEN MOVEMENT IN THAT SPACE BUT
IT'S HISTORICALLY BEEN
CHALLENGING.
WE LOOK TO DIRECT PATIENT
INTERACTION.
>> THERE'S WORK WE DO.
WE DO THAT AND TALK ABOUT THE
REGISTRIES OPEN AND MER
RESOURCES BUT THERE'S MORE WE
CAN DO TO WRAP THAT AROUND SO
THANK YOU FOR RAISING IT.
>> WE'RE MOVING INTO OUR
MODERATED SESSION AND HAVE HALF
AN HOUR TO DISCUSS 10
RECOMMENDATIONS AND SUB
RECOMMENDATIONS BEFORE WE DO
THAT I KNOW WE NEED BLOOD
FLOWING TO OUR BRAIN AND ASK TO
GIVE OUR SPEAKERS A STANDING
OVATION TO STAND UP AND SHAKE
YOUR LEGS OUT.
LIKED TO START WITH
RECOMMENDATION TO 3A AND MOVE TO
3B AND 3C AS WELL.
PERHAPS I CAN START WITH TAKING
THE TEMPERATURE OF OUR FOLKS
ONLIN AND FOLKS IN THE ROOM.
AND HOW WE FEEL WITH DEVELOPING
AND SUPPORTING TRAINING AND
CAREER DEVELOPMENT
OPPORTUNITIES.
WE HEARD A LOT ABOUT THIS FROM
LESLEY AS WELL AS OUR COLLEAGUES
AT SFMF AND ACOG.
DOES ANYBODY WANT TO OPEN WITH
THEIR OBSERVATIONS?
>> WHAT STANDS OUT SO ME IS
THOUGH THE OPPORTUNITIES ARE
MAYBE THERE THEY NEED TO BE
EXPANDED AND IN SOME RESPECTS
IT'S PERVASIVE ACROSS T32s AND
IN THIS SPACE.
>> A CHALLENGE TO THE PROGRAMS
AS THEY CURRENTLY STAND AND
PERHAPS AN ISSUE OF RESOURCING
AS WELL?
ANY OTHER THOUGHTS?
>> DOES ANYBODY HAVE AN OPINION
COUNTER TO THAT?
WITH RESPECT TO THE RESOURCING
FOR THE PROGRAMS.
THEY'RE EXCELLENT IN THEIR
INVESTIGATORS BUT INSUFFICIENT
TO SUPPORT ENOUGH OF THOSE
INDIVIDUALS.
WHILE THEY HAVE A HIGH SUCCESS
RATE OF TURNING PEOPLE FROM K TO
Rs OR F TO Ks TO Rs, THERE'S TOO
FEW TO SUPPORT THE FUTURE
GENERATION OF INVESTIGATORS IN
THESE TOPICS.
TOO FEW SPOTS AND TOO FEW
CENTERS.
>> SO RESOURCING AS WELL.
WHAT HAVE WE HEARD AS IT RELATES
TO THE NON-TRADITIONAL
OPPORTUNITIES AND CERTIFICATION
PROGRAMS AND INTEGRATION.
WE HEARD A LITTLE BIT WITH THE
INTEGRATION OF TRAINEES WITH
PHARMACOLOGY PROGRAMS.
THOUGHTS ON SOME OF THE
NON-TRADITIONAL TRAINING AND
OPPORTUNITIES.
HAVE WE HEARD ENOUGH HERE TO
FEEL THAT HAS SIGNIFICANTLY
PROGRESSED.
I'M TALKING SPECIFICALLY ABOUT
3A SUBBULLET B.
>> THERE'S SOME PROGRESSION BUT
SLOW AND MAYBE NOT TO THE EXTENT
NEEDED AND ONE CONCERN IS WITH
LOSS OF MENTORS AND THE ABILITY
TO FIND MENTORS IS CHALLENGING
FOR PEOPLE.
>> VERY LIMITED.
>> WE'VE SEEN ACTION BUT IT'S
EARLY STAGE OR LIMITED IN SCOPE.
LET'S MOVE ON TO 3AC AND LYNN
CAPTURED CHALLENGES AS IT
RELATES TO BRINGING FOLKS IN TO
THE PHARMACOLOGY AND THERAPEUTIC
SPACE AND OBSTETRICS.
THOUGHTS FROM THE GROUP AS TO
SALARY CAPS, PROTECTED TIME,
ENCOURAGING STUDIES IN THE
OBSTETRIC LACTATION SPACE.
WE DIDN'T TALK ABILITY ABOUT
INFRASTRUCTURE A PART FROM THE
PROGRAMS THAT SUPPORT THE
TRAINING.
ANY THOUGHTS ON THESE PRIMARY
CHALLENGES THAT WERE CALLED OUT?
>> THE LOSS OF THE OPRU NETWORK
IS SAD AND THAT ESTABLISHED THE
ABILITY TO HAVE INFRASTRUCTURE
THAT WOULD HAVE SUPPORTED SOME
OF THE CAREER DEVELOPMENT IN
THERAPEUTICS.
WHAT MIGHT HAVE BEEN GAINED OR
LOST?
>> I DON'T KNOW IF I CAN SPEAK
TO THAT MAYBE OTHERS HAVE
INSIGHT TO THAT QUESTION.
>> WE HAVE DIFFERENT WAYS AND
MODELS TO MOVE FORWARD WITH
THINGS.
WE LAUNCHED THE MATERNAL
THERAPEUTIC HUB WITH A BIG
PRESENCE IN MATERNAL
PHARMACOLOGY WE HAVE
REINVIGORATED THE TERM FETAL NET
WORK AND WE HAVE A LOT OF
LACTATION RESEARCH IN THE
THERAPEUTIC NETWORK AND THE
IMPRINT HUB AND KNOWLEDGE
AGGREGATION HAS A LARGE FOCUS IN
TERMS OF TRAINING AND
INTEGRATION WITH THE WORK THAT
LESLY PRESENTED IN TERMS OF THE
PHARMACOLOGY NETWORK AND THE
IMPRINT HUB HAD INTENTIONALLY
BUILT IN OPPORTUNITY POOL FUNDS
TO PROMOTE CAREERS.
THAT'S THE CURRENT APPROACH THAT
WE'RE TAKING WITH THE RESOURCES
WE HAVE AT HAND TO SUPPORT THAT
TYPE OF INFRASTRUCTURE AND WE'RE
CONTINUING TO LOOK AT WHAT WE
CAN DO WITH THE RESOURCES WE
HAVE.
>> WE HEARD FOR 3AA AND 3AB
LIMITED PROGRESS.
I'D LIKE SOMEBODY TO ENTERTAIN
THE IDEA FOR PROPOSING 3AC WHERE
THEY THINK WE ARE WITH RESPECT
TO PROGRESS.
>> I WOULD SAY AND I GUESS I
SHOULD ASK, FROM WHAT WE FIND,
PEDIATRICIANS ARE USUALLY PRETTY
INFORMED GENERALLY WHEN IT COMES
TO DRUGS AND LACTATION.
NOT TO TOOT OUR OWN HORNS BUT
WE'RE USUALLY THE MOST INFORMED
BECAUSE THAT'S OUR SPECIALTY.
WHAT ARE THE EFFORTS TOWARDS NOT
THOSE INVOLVED IN MATERNAL CHILD
HEALTH BUT THE OTHER
SPECIALTIES.
>> I THINK WE HEARD ABOUT THAT
AND DO YOU WANT TO TOUCH ON
OUTREACH TO SUB SPECIALTIES
OUTSIDE THE OB?
>> THAT'S A REALLY BIG CONCERN.
I THINK WE SHARE THAT CONCERN
AND THE FACT THAT AND I THINK WE
HAVE SEEN THIS IN THE SBKS USE
DISORDER SPACE AS AN EXAMPLE
WHERE A LOT OF ADDICTION
MEDICINE FOLKS ARE HESITANT TO
CARE FOR PREGNANT PATIENTS SO IT
LEAVES AND THERE'S CHALLENGES.
CONVENING SOCIETY TO HAVE THE
CONVERSATION.
IT WILL BE A FIRST STEP AT
THINKING ABOUT JUST AS BECKY
TALKED ABOUT A POTENTIAL TOOLKIT
FOR SHARING WITH OTHERS LIKE HOW
DO WE HELP AMPLIFY THOSE EFFORTS
AND ALSO WHAT ARE THESE OTHER
ORGANIZATIONS WILLING AND ABLE
TO DO AND WHAT DO THEY NEED TO
BE ABLE TO GET THE WORD OUT AND
TRAINING THEIR MEMBERS AS WELL.
>> THANKS, KATIE.
A LOT OF WHAT WE'RE HEARING
BLEEDS INTO SESSION TWO AND THE
CONTENT.
I WANT TO BRING US BACK TO
SESSION 1 TO MAKE SURE WE'VE
CAPTURED THE THOUGHTS OF THIS
GROUP.
SO WE HEARD ERIN AND LESLI TALK
ABOUT THE CHALLENGES LAID OUT IN
THE IMPLEMENTATION PLAN.
IT WOULD SEEM TO ME THAT WE'VE
GOT SOME PROGRESS THERE ALBEIT
LIMITED.
ARE THERE DIFFERENT VIEWS FROM
THE GROUP ABOUT THE PROGRESS
MADE TO 3AC?
SHARON.
I THINK THE BIGGEST PROBLEM I
SEE IS WHEN PEOPLE MOVE OUT OF
THE ACADEMIC CENTERS INTO A
PRACTICE OR GROUP PRACTICE,
PRIVATE, WHATEVER THE MODEL IS.
IT'S ALMOST AN ABRUPT SHUT DOWN
AND WONDER IF THERE'S A METRIC
OR TEACHING -- I DON'T KNOW WHAT
TO CALL IT, PROGRAM, THAT ASKS
FOR THOSE TO MOVE FROM THE
ACADEMIC PRACTICE TO MAINTAIN
SOME RESEARCH INTEREST BE IT
SOME MENTORING, SOME
INVOLVEMENT.
ANYTHING.
I RECOGNIZE IT'S NOT EASY THE
PRACTICES OR TIME CONSTRAINTS
AND HAVING OTHER PEOPLE NICKEL
AND DIMING THEM AND CHECKING.
BECAUSE WE'VE LOST THE GENERAL
PRACTICE, WE'VE LOST THAT I WANT
TO SAY EVERYTHING ELSE YOU KEEP
TALKING ABOUT HERE WE'VE LOST
THE INVESTMENT IN THOSE
CLINICI
CLINICIANS AND LOST THE RESEARCH
THAT IS NOT STRAIGHTFORWARD IN
INSTITUTION PRACTICE AND I THINK
THAT'S THE BIGGEST DROP OFF I
SEE AND I DON'T KNOW HOW TO FIX
IT.
>> WE'RE MISSING THAT
CONNECTION, THAT NETWORK THAT
WOULD FACILITATE THE
CONTINUATION OUTSIDE THE
ACADEMIC CONTENT.
I THINK THAT'S A NICE SYNTHESIS
FOR ADDRESSING THE CHALLENGES
AND STRATEGIES FOR AWARENESS OF
CAREER OPPORTUNITIES.
NOT NECESSARY CAREER
OPPORTUNITIES BUT AN EXTENSION
OF WHAT THEY MAY HAVE BEEN DOING
IN AN ACADEMIC CONTEXT.
CAN I GET THOUGHTS FROM THE
GROUP AS TO WHERE WE STAND ON
PROGRESS, INCREASING AWARENESS
OF CAREER OPPORTUNITIES AND
PHARMACOLOGY AND THERAPEUTICS IN
THE OBSTETRIC AND LACTATION
SPACE.
WE HEARD FROM NICHD THEY'RE
EXPANDING THEIR OPPORTUNITIES AS
WELL.
SOME ARE STILL IN THEIR INFANCY
STAGE.
WE HAVE A LITTLE BIT OF PROGRESS
CAPTURED THERE.
ANY OTHER THOUGHTS HERE?
>> I WANT TO ADD ANOTHER TWO
CENTS IN.
WHEN I READ PROPOSALS, PEOPLE
ARE DOING MORE AND MORE AND MORE
WITH MORE BLOOD AND MORE TIME
CONSTRAINTS ON THE PATIENT SIDE.
IT WOULD BE NICE TO MOVE TO THE
PRACTICE TO ENROLL MORE IN
STUDIES AND PRIMARY CARE DOCS TO
BE INVOLVED AND IF YOU GET TO
STUDY SECTION AND DOESN'T HAVE
PKs FOR 25 MINUTES EVERY 24
HOURS PEOPLE SAY IT WON'T SHOW
ANYTHING BUT MOVING TO OTHER
METHODS, MODELLING SPOTS AND ALL
THE OTHER METHODOLOGY WE HAVE
NOW THAT ARE NOT NEED TO COME TO
THE MOTHER SHIP TO DO IT TO
ALLOW THE PATIENTS TO BE
ENROLLED.
>> THANK YOU, ANY OTHER
THOUGHTS?
>> I THINK IT'S REALLY
INTERESTING.
ONE THING THAT IMMEDIATELY COMES
TO MIND AS A POTENTIAL BARRIER
IS HOW OBSTETRIC CARE IS
TRADITIONALLY PAID FOR IN THE
BUNDLED PAYMENT.
THAT'S NOT THE ACROSS THE BOARD
BUT ENDS UP BEING ABOVE ALL
PAYMENT AND DOESN'T ALLOW FOR
ANY SORT OF -- IT MAKES RESEARCH
CHALLENGING TO UNDERSTAND IF
THEY LOOK AT CLAIMS TO DATA AND
IT'S HINDERED AS A CODE AND
THAT'S SOMETHING WE'RE ACTIVELY
WORKING ON.
IT'S GOING TO BE A YEAR'S LONG
PROCESS.
THAT I THINK RELATES SOMEWHAT
WITH BRINGING THE RESEARCH TO
THE ENCOUNTERS OUTSIDE THE
RESEARCH PURELY ACADEMIC OR
RESEARCH FACILITY.
>> THAT WOULD BE THE IDEAL.
I WONDER HOW TO OPERATIONALIZE
IT THE FUNDING FOR COORDINATORS
AND ALL THAT STUFF IT TAKES TO
RUN NETWORK AT AN ACADEMIC
CENTER ARE OFTEN UNDER
RESOURCED.
YOU'RE ASKING A PRIVATE PRACTICE
TO SAY I'M GOING TO TAKE AN HOUR
OF MY TIME TO DO THIS OR HAVE A
CORNER THAT'S THE OTHER SIDE THE
RESOURCE FUNDING IN THE
COMMUNITY.
>> WE HAD OUR MONKEY POX MINI
EPIDEMIC AND TRANSITIONED FROM
DOING THE WORK AT THE MOTHER
SHIP TO DISTAL BLOOD DRAWS AND
MAILING.
IT'S BEEN QUITE SUCCESSFUL REWE
GETTING INTENSIVE PKs, NO?
ARE WE ABLE TO GET THEM THROUGH
USING A.I. KIND OF STUFF?
YES.
I WANT TO SAY THE FACT MOST OF
OUR IRBs REQUIRE AN IN PERSON
CONSENT HAS TO STOP.
MOST THE FACT IN OUR IRBs
REQUIRE ENORMOUS INFRASTRUCTURE
TO ENROLL ONE PATIENT HAS TO
STOP.
ON OUR SIDE AS SENIOR
INVESTIGATORS WE NEED TO
ENCOURAGE THE JUNIORS TO BE
CREATIVE ON YOUR STUDY SECTION
AND FOR THOSE WHO SIT ON STUDY
SECTION, A LITTLE EDUCATION
SAYING YES, LET'S STOP WITH THE
OH, YOU NEED TO COME TO THE
MOTHER SHIP AND THERE'S
EDUCATION ON THE IRB SIDE AND
PATIENT SIDE AND WITH MONKEY POX
WE'VE ENROLLED 50 PATIENTS PLUS
ON THE STUDY AND SHIPPING THEIR
MEDS, GETTING THEM TREAT AND
COLLECTING DATA.
DOES IT TAKE SOME
INFRASTRUCTURE?
YES.
IS IT LIKE THE MOTHER SHIP?
NO.
>> I DON'T WANT TO TRUNCATE THIS
DISCUSSION BUT OUR GOAL IS NOT
TO SOLVE THE PROBLEM BUT ADDRESS
THE PROGRESS TO DATE AND WE'RE
IDENTIFYING KEY OPPORTUNITIES
THAT CAN BE DISCUSSED.
I THINK WE'RE ALSO HEARING
BARRIERS FROM AN ANGLE OF ATTACK
THAN WHAT'S TRADITIONALLY BEEN
DONE AND GROWING PROGRAMS AND
THERE MAY NEED TO BE ADVOCACY IN
PLACE AND AS IT RELATES TO I AM
BURSTMENT AND INCENTIVIZATION.
WE'RE HEARING THIS IS THERE'S
PERHAPS A LITTLE BIT OF PROGRESS
HERE BUT THERE'S FAR MORE
OPPORTUNITY THAT CAN BE USED TO
LEVERAGE THIS PARTICULAR AREA.
>> I WANTED TO AGREE AND UNDER
SCORE DR. YE'S COMMENTS ABOUT
THE CHALLENGING TO TRAINING AND
COMPREHENSIVELY PUT.
THE TWO PIECES I MAY ADD TO OUR
DISCUSSION IS CONTEXT FOR
ADVANCEMENT FOR TRAINEES AND THE
PHARMACOLOGIC OR LACTATION
WORKFORCE SHIFTING TO A
CHILDBEARING POPULATION AND THE
IRONY OF NOT CREATING
INFRASTRUCTURE FOR THOSE PEOPLE
TO COMPLETE THEIR CHILDBEARING
DESIRES.
WHEN YOU'RE AT A STAGE OF
BECOMING A PHYSICIAN SCIENTIST
AND YOU HAVE TO CHOOSE IF YOU
CAN FEEL A PARENT IN THE WAY YOU
WANT TO.
I WOULD ARGUE THAT'S TRUE
WHETHER OR NOT YOU'RE BEARING A
CHILD YOURSELF.
YOUR TRAINING DOESN'T EXTENT.
YOU'RE PROTECTED TIME DOESN'T
EXTEND IF YOU CHOOSE TO HAVE A
CHILD AND WHAT'S THAT MEAN FOR
YOUR LIFE LONG IMPLICATIONS AS A
SCIENTIST AND THAT'S NOT BEEN
ADDRESSED WELL AND THE ONE PIECE
I WOULD ADD AND THE ADDITIONAL
THING ABOUT AWARENESS OR LINKAGE
TO OTHER PROGRAMS IS I'VE NOT
SEEN A ROBUST DISCUSSION ABOUT
CONNECTION TO OUR PHARMACY
COLLEAGUES AND PHARMACY
PHYSICIAN SCIENTIST TRAINING
PROGRAMS AND PARTNERSHIPS ACROSS
SOCIETIES FROM ACOG TO THE
AMERICAN PHARMACY ASSOCIATION.
THOSE ARE THE TWO AREAS I'M
CURIOUS ABOUT BUT THANK YOU SO
MUCH FOR EVERYTHING.
>> GREAT.
OUTLINING OPPORTUNITIES AND
MOVING US ALONG AND THE IDEA OF
CHILDBEARING AGE IN THE
WORKFORCE IS CROSS CUTS ACROSS
ALL DISCIPLINES AND IRONIC IN
THE OB SPACE.
LET'S MOVE TO 3B, DEVELOP
MENTORS IN OBSTETRIC AND
LACTATION PHARMACOLOGY AND
THERAPEUTICS FOR BOTH CLINICAL
AND BASIC SCIENCE.
AND HELPING MENTEES FIND
MENTORS.
PERHAPS INCREASING SUPPORT FOR
MENTORS SEEMS TO BE PART OF THE
CONVERSATION BUT I DON'T KNOW WE
HEARD ANYTHING IS ACTUALLY BEING
DONE ABOUT THAT TO ENSURE
THERE'S APPROPRIATE MENTORS IN
THE FIELD AND WE HEARD FROM SARA
WE'RE LOSING MENTORS AS WELL AND
TRAINING ON FDA REQUIREMENTS AND
PROCESSES.
WE HEARD A LITTLE BIT ABOUT
BEING INTEGRATED IN THE BROADER
TRAINING INITIATIVES WITHIN AND
OUTSIDE OF NICHD.
I THINK WE HAVE A MIXED BAG TO
MY EAR WITH RESPECT TO WHERE WE
ARE FROM A PROGRESS STANDPOINT
ON 3B.
ANY SPECIFIC THOUGHTS, COMMENTS
FROM THE GROUP?
>> I WANT TO COMMENT ON 3A
SUPPORT FOR MENTORS WHICH IS A
DEFICIT.
I WANT TO HEAR WHY K24 MECHANISM
IS PART OF NICHD'S PORTFOLIO IF
ANYONE KNOWS.
AT OTHER INSTITUTES I HEAR MID
CAREER FACULTY HAVE K24 THAT
PROTECTS THEIR TIME FROM
MENTORING AND FINDING THIS A
SUCCESSFUL MECHANISM TO PROMOTE
MENTORSHIP PROTECTED TIME.
FOR PEOPLE MOSTLY FUNDED BY
NICHD, THIS ISN'T USUALLY AN
OPTION AND MENTORSHIP IS
EXPECTED TO BE DONE ON OTHER
INDEPENDENT GRANTS AND SQUEEZING
THE CORNERS OF EVERYTHING ELSE.
I THINK CONCRETE FUNDING FOR THE
PURPOSE OF MENTORSHIP IS A MAJOR
AREA IN WHICH WE HAVE LITTLE TO
NO PROGRESS.
>> LESLI OR ERIN, DO YOU WANT TO
RESPOND?
>> HAPPY TO RESPOND.
I'LL GO BACK TO THE RFI AND
RECOMMENDATIONS FROM THIS WORK
GROUP AND MAKING SURE THEY GET
COMMUNICATED TO THE RFI AND IF
THE COMMITTEE DOES FEEL THAT,
THAT MIDSTAGE MENTORING AREA IS
ONE WHERE WE NEED MORE SUPPORT,
PLEASE COMMUNICATE THAT.
WE HAVE A LIMITED -- THERE'S A
LIMITED BUDGET AND A VARIETY OF
MECHANISMS WE CAN USE AND THE
INSTITUTE TYPICALLY MAKES
DECISIONS BASED ACROSS THE
ENTIRETY.
SOME MECHANISMS ARE USED, SOME
ARE NOT.
IT'S ONE OF THE REASONS WE'RE
ABLE TO GET A K12 PROGRAM GOING
WHICH DOES FIT A LITTLE BIT OF
THE MENTORING SPACE.
I'VE SEEN K24 MECHANISM BE VERY
SUCCESSFUL.
I'LL LEAVE IT UP TO YOU TO
RECOMMEND.
>> YOUR RELATED SUGGESTION IS IF
A K24 WAS SOMETHING NICHD COULD
DEVELOP PERHAPS THE OTHER
MECHANISM COULD INCLUDE FUNDED
FOR THE EFFORT AND OTHERWISE
THEY'RE PUTTING UNFUNDED TIME.
>> WE'RE PUTTING PURCHASE ON
NICHD BUT THERE SHOULD BE FUND
FROM OTHER INSTITUTES AS WELL.
DO YOU HAVE ANY FOR US OR LESLY
ON ANY OF THE POTENTIAL K
FUNDING THAT MIGHT BE RECEIVE
THE IN THIS MATERNAL LACTATION
SPACE FROM OTHER INSTITUTES?
>> ONE THING I'LL MENTION I
THINK IS RELEVANT TO THIS IS THE
NIH PEDIATRIC LACTATION COUNCIL
WHEN DIANA BIANCHI JOINED AND
THERE'S BEEN A PEDIATRIC AND
PHARMACOLOGY DISCUSSION GROUP
AND STARTING TO ENGAGE THE OTHER
I.C.s IN A MORE FORMAL CAPACITY
TO DISCUSS TRAINING AND TRAINING
AND CAREER DEVELOPMENT WAS AN
ITEM THAT CAME UP AS A KEY
THINGS TO DISCUSS.
IT'S A THEME LESLY WAS
DESCRIBING, THE MAJORITY OF THE
FUNDING TO TRAINING AND CAREER
AWARDS COMES THROUGH PARENT
SOLICITATIONS.
I THINK ONE ASPECT OF THIS IS
ENCOURAGING INDIVIDUALS TO APPLY
FOR Ks AND T32s AT INSTITUTES
WHERE THERE COULD BE RELEVANT
APPLICATION.
IF SOMEBODY LOOKING AT ASTHMA
MEDICATIONS COULD APPLY FOR A K
AT HEART LUNG, DIABETES
MEDICATIONS THAT COULD BE
SOMETHING THAT GOES TO NIDDK OR
POTENTIALLY NICHD.
A COUPLE THINGS THAT COME UP THE
BRCH PROGRAM DUE TO
CONGRESSIONAL ALLOCATIONS AN
RESOURCES WERE ABLE TO HAVE
UNIQUE AND SPECIAL PROGRAMS AND
LEVERAGE LESLY BUILT UP WAS DUE
TO LEGISLATION.
I THINK I'M HEARING A COUPLE
THINGS I THINK WE NEED TO
EDUCATE INVESTIGATORS ABOUT
OPPORTUNITIES MORE BROADLY AND
DO WHAT WE CAN WITH THE RESOURCE
ARE WE HAVE IN HAND.
>> THANK YOU.
I'LL MOVE US.
I UNDERSTAND WE ARE AT OUR BREAK
TIME AND I'LL MOVE US QUICKLY TO
3C.
INCREASING KNOWLEDGE AND
ENGAGEMENT OF HEALTH CARE
PROVIDERS REGARDING OB AND
PHARMACOLOGY AND THERAPEUTICS.
WHAT I HEARD FROM TODAY'S
DISCUSSION WAS A LOT OF PROMISE
BUT PERHAPS NOT A LOT OF
PROGRESS.
SO I THINK THIS IS KIND OF A RUN
ARING THEME FOR THIS MORNING'S
SESSION BUT WOULD LIKE TO GET
SOMEBODY TO RECOMMEND WHERE WE
LIE WITH RESPECT TO 3C.
BECKY.
>> NOT MUCH PROGRESS.
I WONDER IF ANYBODY HAS
INFORMATION ABOUT 3CC, ABOUT
EMRs.
IS THAT EVEN A THING ANYONE'S
DOING?
>> I KNOW THERE'S SOME
INDIVIDUAL INSTITUTIONS DOING
THAT WORK BUT I DON'T KNOW
THAT -- I'M NOT AWARE OF
ANYTHING CROSS CUTTING BEYOND
THE SINGLE INSTITUTION.
>> A CLARIFYING QUESTION BECAUSE
THE NOT MUCH PROGRESS IS WHAT
WE'RE HEARING BUT WONDERING FOR
ACOG AND MAYBE THIS IS MORE OF
AN ABOG QUESTION WHEN YOU TALK
ABOUT THE TRAINING THAT SHOULD
BE HAPPENING TO THE 60,000 PLUS
OB-GYNs DO WE HAVE DATA ON HOW
MUCH ARE AVAILING THEMSELVES TO
THE MORE IN DEPTH TRAINING?
MY SENSE IS WHEN WE TALK IN THE
ACADEMIC CIRCLES THE KNOWLEDGE
AT THAT LEVEL IS VASTLY
DIFFERENT THAN THE BOOTS ON THE
GROUND AND COMMUNITY DOCS MOST
US PATIENTS ARE SEEING?
>> BEFORE THEY CAN AVAIL
THEMSELVES IT HAS TO BE
AVAILABLE.
I DON'T THINK WE HEARD THERE'S
SPECIFIC PHARMACOLOGY TRAINING
MODULES THAT WERE AVAILABLE.
>> I THINK WE CAN SAY WE'RE NOT
GETTING IT PERCOLATING TO THE
GENERALISTS.
>> SO WE HAVE CAPTURED AND I
APOLOGIZED FOR RUNNING A LITTLE
BIT OVER AND WE HAVE CAPTURED
WHERE THE PROGRESS IS FOR
RECOMMENDATION 3.
WE'LL HAVE MORE TIME LATER.
DOES ANYBODY HAVE ANY STRONGLY
DISSENTING OPINIONS ABOUT WHAT
WE'VE DISCUSSED THIS MORNING?
IF THAT'S THE CASE, THANK YOU
VERY MUCH FOR WONDERFUL DISCUSSION AND COMMENTS.
I'D LIKE TO THANK THE SPEAKERS AGAIN AND WE CAN MOVE INTO A
LITTLE BIO BREAK.
THIS IS CHRISTINA AND WE'LL
START SESSION 2.
THE FOCUS IS GOING TO LARGELY BE
AROUND COMMUNICATION, EDUCATION,
OUTREACH.
POOLING SOME TEAMS FROM THIS
MORNING INTO THAT AS WELL.
WE'RE THRILLED TO HAVE TWO
SPEAKERS TO PRESENT ONGOING
ACTIVITIES.
THESE INCLUDE THE CDC THE CENTER
ON DEVELOPMENT DISABILITIES.
AND WARE ALSO GOING TO INCLUDE
TINA CHAMBERS WHO IS AT UC SAN
DIEGO.
I THINK OUR AGENDA HAS THEM IN
THE ALTERNATE ORDER BUT WE'LL
FOCUS ON RECOMMENDATIONS 5 AND
6.
>> GOOD MORNING.
THANK YOU FOR INVITING ME TO BE
HERE TODAY.
I'M THE ASSOCIATE DIRECTOR FOR
COMMUNICATION DIVISION OF BIRTH
DEFECTS AN INFANT DISORDERS,
KARA POLEN.
BEFORE I BEGIN TO SET THE STAGE
A LITTLE BIT.
SOME KNOW CDC HAD AN IN FUNDED
INITIATIVE IN THE EARLY 2010s
CALLED TREATING FOR TWO AND
SOUGHT TO ADVANCE INFORMATION OF
MEDICATION USE DURING PREGNANCY
AND WE'LL DESCRIBE SOME OF WHAT
WE LEARNED THROUGH THAT WORK AND
IN THE TIME SINCE WE'VE HAD
SEVERAL PUBLIC HEALTH
EMERGENCIES BETWEEN ZIKA AND
COVID.
OUR COMMUNICATION WORK HAS BEEN
MORE FRAGMENTED BUT YOU'LL SEE
ELEMENTS THROUGH OUR EFFORTS
WHICH I'LL DESCRIBE.
WE ACKNOWLEDGE NOT EVERYONE
PERSON WHO CAN BECOME PREGNANT
IDENTIFIES AS A WOMAN MUCH THE
CURRENT RESEARCH AVAILABLE
CURRENTLY REFERS ONLY TO WOMEN
WHEN DISCUSSING WHO CAN BECOME
PREGNANT BUT WHERE POSSIBLE WE
TRIED TO USE PREGNANT PEOPLE OR
PREGNANT PATIENT AS WELL.
MEDICATION AMONG PREGNANT PEOPLE
IS COMMON.
9 OUT OF 10 INDIVIDUALS IN THE
UNITED STATES TAKE MEDICATION
TRANSLATING TO 5.5 MILLION
PREGNANCIES.
MEDICATION USE IN PREGNANCY
RAISES QUESTIONS FOR THE
INDIVIDUALS, PARTNERS AROUND
FAMILIES AND HEALTH CARE
PROFESSIONALS.
MOST ARE FACED WITH THE QUESTION
IS THE MEDICATION SAFE FOR ME
AND MY BABY AND WE HEARD STORIES
ABOUT PATIENTS RECEIVING
CONFLICTING INFORMATION LIKE
STOPPING MEDICATIONS BECAUSE OF
FEAR OF THE UNKNOWN.
A LITTLE BIT OF MY FORMATTING IS
MESSED UP AS WELL.
WE'RE GOING TO MOVE THROUGH.
FROM THE COMMUNICATION
PERSPECTIVE WE SOUGHT TO
UNDERSTAND ATTITUDES AMONG
WOMEN, HEALTH CARE PROVIDERS AND
PHARMA
PHARMACISTS.
I'LL TALK ABOUT THOSE FINDINGS
AND THE TIME SINCE.
WE HAD FOCUS GROUPS OF THOSE
TAKING PRESCRIPTION MEDICATION.
WE CONDUCTED INTERVIEWS INTO
THEMES.
SOME TOPICS WE EXPLORED DURING
THE WORK WAS THE INFLUENCE OF
HAVING CHRONIC CONDITION VERSUS
ACUTE CONDITION ON KNOWLEDGE,
ATTITUDES AND BEHAVIORS.
WHETHER WOMEN CREATED TREATMENT
PLANS AND HOW THEY PERCEIVED
MEDICATION USE AS COMPARED TO
OTHER BEHAVIORS WITH PREGNANCY.
MESSAGING THEY RF -- THEY'D
WISHED THEY'VE RESOURCED AND THE
MOST WIDE CONCERN IS SOMETHING
TAKEN DURING PREGNANCY CAN CAUSE
HARM AND WHEN PROBED FURTHER
THEY FELT THERE COULD CAUSE
PREMATURITY OR BIRTH EFFECT OR
LONGER TERM EFFECT SUCH AS
OBESITY, ASTHMA RECENTLY WE
HEARD IN THE AUTISM SPACE AND
CONCERNS ABOUT THAT.
PARTICIPANTS ACKNOWLEDGE
CONCERNS ABOUT THEIR OWN HEALTH.
MANY DESCRIBED, GUILT, FEAR AND
ANXIETY ABOUT THE USE OF
MEDICATION DURING PREGNANCY
WHILE RECOGNIZING A MOTHER'S
HEALTH WAS IMPORTANT.
HERE'S A QUOTE.
THOUGH THEY WERE WORRIED HOW
MEDICATIONS MAY AFFECT THE FETUS
AND SHOULD THEY TAKE A
MEDICATION TO MANAGE THEIR
CHRONIC CONDITION.
PARTICIPANTS SAID IF A RISK OF A
MEDICATION WAS UNKNOWN THEY
WOULD NOT TAKE IT.
THE WOMEN SAID THEY CONSIDERED A
MEDICATION WITH UNKNOWN FETAL
RISKS WHICH IS THE MAJORITY OF
WHAT WE KNOW SO A BIT SURPRISED
BY THAT.
PARTICIPANTS WANTED AS MUCH
DETAILED INFORMATION AN SPECIFIC
TOPICS ARE LISTED HERE BUT YOU
CAN'T REALLY SEE THEM.
THEY WERE INTERESTED IN KNOWING
THE POTENTIAL ADVERSESQUESS --
ADVERSE EFFECTS AND RISK DURING
THE FETUS AND IN THE PREGNANCY
AND WE KNOW PROVIDERS ARE
TRUSTED SOURCES OF INFORMATION
BUT WE WERE CURIOUS ABOUT WHICH
DOCTOR THEY TRUSTED MOST DURING
PREGNANCY.
OVERWHELMINGLY WOMEN REPORTED
THEIR OB-GYNs WERE TRUSTED
SOURCES DURING PREGNANCY AND IN
ADDITION THEY CITED OTHER
SOURCES LIKE FRIENDS AND
RELATIVES AS WELL AS ONLINE
BLOGS AND SOCIAL NETWORKING
SITES AS PLACES THEY WENT TO FOR
INFORMATION.
SEVERAL EXPRESSED FRUSTRATION IN
CONFLICTING INFORMATION.
THEY WISHED THEY RECEIVED THE
SAME INFORMATION FROM ALL
PROVIDERS AND INDICATED THE
CONSISTENCY WOULD HAVE ENHANCED
THE TRUST WORTHINESS.
INFORMATION FROM A DOCTOR WAS
VALIDATE INTERNET RESOURCES OR
OTHER SOURCES WOULD HELP THEM
FEEL MORE CONFIDENT AROUND
MEDICATION USE.
PARTICIPANTS TALK ABOUT THE
QUESTIONS WITH OTHER TRUSTED
SOURCES LIKE FRIENDS AND FAMILY
OR READ BLOGS FROM PEOPLE WHO
HAVE GONE THROUGH SIMILAR
EXPERIENCES.
AND THEY MENTION HEARING SIMILAR
EXPERIENCE WAS A POWERFUL SOURCE
OF INFORMATION THAT SUPPLEMENTED
FACTS IN RESEARCH.
THEY CONDUCTED A NATIONAL SURVEY
AND PROVIDERS WERE TREATED
DURING CLINICAL VISITS,
WIDESPREAD PROVISION OF SAFE
LISTS AND UNLIMITED COUNSELLING
FOR PREGNANCY AN IMPLICATIONS
FOR THE GROUPS INCLUDING
IMPROVED DIGITAL TOOL FOR
DISCUSSING INFORMATION IN
CLINICAL SETTINGS, INTEGRATING
LINKS TO LOCAL RESOURCES,
DEVELOPING MORE EVIDENCE-BASED
WRITTEN INFORMATION FOR
PHYSICIAN TO SHARE WITH PATIENTS
AND ENCOURAGING COUNSELLING OF
WOMEN OF REPRODUCTIVE AGE OF
USE.
WE HAVE DIFFERENT RESOURCES AND
WORKED ON NEW RESOURCES LIKE THE
ONE TO THE RIGHT AND BRING THE
CONVERSATIONS TO THE HEALTH CARE
PROVIDERS AND TALK TO THEM
BEFORE AND DURING THE PREGNANCY.
AND WE HAD ONLINE ACTIVITIES AND
SOCIAL MEDIA AND PARTNERED WITH
DIFFERENT BLOGGERS BACK IN 2018.
BLOGGERS ARE NOW WHAT YOU'D CALL
INFLUENCERS.
WE TRIED TO AMPLIFY THIS AT THE
TIME.
YOU'LL LOOK AT OUR DISSEMINATION
AND EFFORTS.
SORRY ABOUT THE SLIDES.
THIS IS DESCRIBING A RECENT
SURVEY WE CONDUCTED IN LATE
SUMMER OF LAST YEAR.
SO WE WERE INTERESTED IN
TERMINOLOGY SPECIFICALLY AROUND
BIRTH DEFECTS BECAUSE THAT'S THE
TOPIC FOR OUR DIVISION AND
INFORMATION-SEEKING PRACTICES
CONSIDERING THE PANDEMIC CHANGED
HOW PEOPLE RECEIVE INFORMATION.
AND WANTED TO SEE IF IT'S
CONSISTENT WITH WHAT WAS
PREPANDEMIC VERSUS NOW.
A LOT OF IT IS WHAT YOU WOULD
EXPECT AND WHERE YOU GO FOR
INFORMATION ON PREGNANCY AND
BABY HEALTH AND THE MAJORITY
SAID ASK A PROFESSIONAL AND A
NUMBER SAID ASK A FAMILY MEMBER
OR SEARCH THE INTERNET AND
MESSAGING TO OLDER GENERATIONS
AND PEOPLE IN THEIR LIVES.
AND HOW YOU WOULD LIKE TO
RECEIVE INFORMATION ABOUT THE
TOPIC.
MOST SAID THEY WOULD PREFER A
CONVERSATION WITH FROM DOCTOR
AND TEXTING, VIDEOS, WE HAVE A
STUDY TO EVALUATE PREGNANCY
EXPOSURES.
WE ADDED QUESTIONS AROUND RISK
COMMUNICATION AND THIS IS BASED
ON POPULATION-BASED SURVEILLANCE
PROGRAMS IN SEVEN STATES.
FOR THIS PART OF THE STUDY AND
WOMEN ARE ASKED HOW THEY TALK TO
THEIR HEALTH CARE PROVIDER ABOUT
TREATMENT OPTION.
WE'RE START THE ANALYSES.
WE'LL BE SURE TO UPDATE YOU WHEN
WE HAVE THE RESULTS.
AND THERE'S FORMATIVE RESEARCH
THAT LOOKS AT PREGNANCY AND
OPTIMIZE HEALTH BEFORE AND AFTER
PREGNANCY.
THIS WAS BORN OUT OF OUR
EXPERIENCE AFTER COVID.
I WAS INTERESTED IN HOW PEOPLE
INTERPRET RISK IN THE CONTEXT OF
UNCERTAINTY AND DATA.
WE KNEW PEOPLE WERE CONCERNED
ABOUT RISK OF VACCINATION DURING
PREGNANCY.
THAT'S A LOT OF THE WORK I DID
DURING THE PANDEMIC AND SEEMED
LESS CONCERNED ABOUT THE RISK OF
INFECTION.
AT THE TYPE OF WE HAD A LOT OF
INFORMATION ABOUT AND SAW
MISINFORMATION AND INCONSISTENT
GUIDANCE AND CONFLICTING
INFORMATION PROLIFERATING ONLINE
CONTRIBUTING TO DISTRESS AND
CONFUSION.
THE IMPETUS IS WHAT CAN WE LEARN
MOVING FORWARD AND THIS IS IN
AGREEMENT WITH A HEALTH
COMMUNICATION FIRM CARNA.
THEY STARTED WITH THE LITERATURE
REVIEW AND I HIGHLIGHTED THEIR
FINDINGS ON THE SLIDE WHICH
CANNOT SEE.
EARLY FINDINGS FROM THE
LITERATURE REVIEW IS MORE
CONSISTENT WITH PREVIOUS
KNOWLEDGE ON THE TOPIC.
SO THERE'S A HEIGHTENED
PERCEPTION OF RISK DURING
PREGNANCY AND OVER ESTIMATION OF
RISK AND MEDICATION AND RELIANCE
ON INTERNET SOURCES AND FAMILY
AND FRIENDS FOR INFORMATION AND
CONFLICTING ISSUES WERE LANGUAGE
BARRIERS AND PLAIN LANGUAGE AND
VISUALS AND INFORMATION TAILORED
TO THE AUDIENCES.
NEXT STEPS INCLUDE A FOCUS GROUP
AND SURVEY.
WE HAVE SIX GROUPS PLANNED RIGHT
NOW, A COUPLE WITH THOSE
PLANNING PREGNANCY.
A COUPLE WITH THOSE CURRENTLY OR
RECENTLY PREGNANT FOR THE FIRST
TIME AND A COUPLE RECENTLY
PREGNANT BUT NOT FOR THE FIRST
TIME CONSIDERING RISK TOLERANCE
IS PROBABLY PREGNANT PREVIOUSLY.
DOMAINS WE'RE HOPING TO EXPLORE
IS RISK PERCEPTION AND
COMMUNICATION AND INFORMATION
SEEKING, MESSAGING AND FRAMING
LOOKING AT GAME FRAME MESSAGES
VERSUS LOSS FRAME.
WE EXPECT TO EXPLORE SCENARIOS
AND MEDICATION FOR DEPRESSION IS
ONE WE'LL BE ASKING QUESTIONS
ABOUT.
CONCEPTS OR APPROACHES ARE SHOWN
HERE.
RISK TO MOM VERSUS BABY AND
INFORMATION ON SPECIFIC TOPICS
VERSUS GROUPED INFORMATION.
USING DATA VERSUS STORY TELLING
TECHNIQUES AND HAVING GUIDANCE
WITH AN EXPLANATION OR MORE
DIRECTED STYLE AND USING
TESTIMONIALS.
THIS IS A WORK IN PROGRESS.
WE'VE NOT FIELDED THE FOCUS
GROUPS YET WE'RE PLANNING FOR
NEXT MONTH.
IF YOU HAVE SUGGESTIONS WE'RE
OPEN TO FEEDBACK AT THIS STAGE.
I CAN FIND ME AFTER THE
PRESENTATION.
MOVING ON TO OUR INFORMATION
DISSEMINATION.
WE PRESENTLY SHARE CLEAR
MESSAGING AN HAVE NEW FINDINGS
OUT OF CUC.
THIS SLIDE SHARES A COUPLE
EXAMPLES NOT SPECIFIC TO
MEDICATIONS IN PREGNANCY BUT AND
THE RSV VACCINE AND WE USED
PATIENT TESTIMONIALS
HIGHLIGHTING PEOPLE'S
EXPERIENCED AND THE CAPTION
INFORMATION THEY MAY NEED TO
KNOW.
AND ON THE RIGHT IS A VIDEO ON
FOLIC ACID.
THERE'S BEEN MISINFORMATION AND
LOOKING AT THE LABEL IT SEE IF
THEY HAVE THE RECOMMENDED AMOUNT
OF FOL IC ACID INCLUDED.
MOVING ON TO PARTNERSHIPS.
WE PARTNER WITH MOTHER TO BABY.
I WON'T TALK MUCH ABOUT THAT
BECAUSE TINA WILL DISCUSS PART
OF THIS AND WE HAVE A RECIPROCAL
PARTNERSHIP AND THIS HELPS
UNDERSTAND COMMON CONCERNS AMONG
THEIR AUDIENCE AND THIGH
RECEIVED CALLS ABOUT EXPOSURE
AND THE FEEDBACK FROM THE CALL
DATA AND TRY TO UNDERSTAND WHAT
MAY BE CONFUSING OR TAILOR
MESSAGING AND SHARE BACK WITH
SMEs TO DIG DEEPER IF THERE'S
QUESTIONS WE DON'T HAVE ANSWERS
TO.
ALSO, WHEN WE HAVE UPDATED
INFORMATION OR NEWS ESPECIALLY
DURING RESPONSE TIME WE SHARE
THAT WITH MOTHER TO BABY TO MAKE
SURE WE'RE ALL ON THE SAME PAGE
AROUND GUIDANCE COMING OUT AND
HELP DISSEMINATE WITH MANY
EXAMPLES SHOWN HERE.
THEY HAVE FACT SHEETS AND
PODCASTS TO HELP DISSEMINATE
THIS MORE BROADLY.
WE TOUCH BASE REGULARLY TO TALK
ABOUT DIFFERENT EXPOSURES DURING
PREGNANCY ESPECIALLY DURING
RESPONSE TIMES AGAIN.
THIS HELPS TO ENSURE CONSISTENT
RECOMMENDATIONS AND EDUCATED
POWER WOMEN'S HELP PROVIDERS AND
RECRUT CHAMPIONS.
IN TERMS OF SOME OF OUR FUTURE
STEPS IN THE SPACE, I VIT
OUTLINED BY SHORT TERM ACTIONS
VERSUS LONGER TERM
OPPORTUNITIES.
IN THE SHORT TERM THESE ARE
THINGS OUR TEAM IS CURRENTLY OR
PLANNING TO DO THIS YEAR.
WE'RE CONCERNED ABOUT MEETING
PEOPLE WHERE THEY ARE IN THE
COMMUNICATION SPACE WHETHER
HEALTH CARE PROVIDERS OR
PREGNANT INDIVIDUALS.
WE'RE LOOKING TO LOOK AT DIGITAL
PLATFORMS FOR HEALTH CARE
PROVIDERS AND UP TO DATE AND SEE
IF THEY HAVE GUIDANCE OR PATIENT
MATERIALS OR THINGS EASILY
ACCESSIBLE TO PROVIDERS IN THE
CLINICAL SETTINGS AND WE'RE
PLANNING TO SAYS INFORMATION ON
PREGNANCY PLATFORMS LIKE WHO
WHAT TO EXPECT TO UNDERSTAND
WHAT THEY'RE COVERING ON THE
TOPIC AND HOW WE CAN BETTER
INFORM THOSE AND POTENTIALLY
PITCH NEW CONTENT TO THOSE
PARTNERS.
WE'RE WORKING TO EXPAND OUR
PARTNERSHIPS WITH NURSES,
MIDWIFES AND NURSE PRAC TITITIOS
AND SHARING WITH AUDIENCES.
IN TERMS OF LONGER TERM
OPPORTUNITIES, WE'RE WORK ON
IMPROVING OR BASED ON THIS IS
NOT SOMETHING C.D.C. IS
CURRENTLY DOING BUT IDEAS FOR
CONSIDERA
CONSIDERATIONED AND PROVIDING
CARE TO PREGNANT INDIVIDUALS AND
WE HAVE EMERGENCY MEDICINE
DOCTORS AND THINGS LIKE THAT WE
CAN POTENTIALLY EXPLORE FURTHER
TO HELP MAKE SURE WE'RE
DISSEMINATING INFORMATION IN THE
RIGHT WAY AND GETTING THE
INFORMATION TO THOSE WHO NEED
IT.
ENHANCE
ENHANCING AND STORIES AN VISUALS
AND PARTNERING WITH OTHER
EXPERTS LIKE LACTATION AND
RESPONSE AND CONSOLIDATED HUB
WHICH SOUNDS SIMILAR TO WHAT
BECKY ALREADY DESCRIBED.
SOME KEY POINTS TO REITERATE ARE
PATIENTS ARE HIGHLY MOTIVATED TO
PROTECT THEIR BABIES, STRATEGIC
MESSAGE AND IMPROVED RESOURCES
CAN HELP MAXIMIZE THE
PATIENT-PROVIDER INTERACTION AND
A MULTI-PRONGED APPROACH SNEIS
KNEADED TO SHARE THE
INFORMATION.
THAT'S ALL I HAVE.
THANK YOU.
SORRY ABOUT THE FORMATTING.
>> THANK YOU, KARA.
WE APPRECIATE THE BREADTH OF
WHAT YOU TRIED TO COVER IN SUCH
A SHORT PERIOD OF TIME.
THANK YOU VERY MUCH.
I THINK WE HAVE TIME FOR A
HARD-HITTING CLARIFICATION
QUESTION.
>> THANK YOU.
I LOVE ALL THE RESOURCES YOUR
TEAM IS WORKING ON.
I'M FROM NICHD.
A CLARIFYING QUESTION ABOUT THE
PAST EFFORTS FOR FUTURE PLANS.
IS THERE AN OPPORTUNITY TO
PROMOTE THE INCLUSION OF
PREGNANT AND LACTATING WOMEN IN
RESEARCH THROUGH YOUR EFFORTS?
>> YES.
WE CAN ALWAYS ADD INFORMATION
AND THE CDC WEBSITE DOES LINK TO
DIFFERENT RESOURCES POTENTIAL
REGISTRIES AND THERE'S ALWAYS
OPPORTUNITY TO BUILD THAT OUT
MORE DEFINITELY.
>> RACHEL.
>> I WAS EXCITED TO HEAR ABOUT
THE FOCUS GROUPS AND WONDERING
IF YOU CAN TALK WHAT YOU EXPECT
THE FINAL PRODUCT OF THAT TO BE
IF THERE IS ONE.
AND WHO THE TARGET AUDIENCE
WOULD BE OF THAT.
>> THE FOCUS GROUP WORK I'M
TALKING ABOUT IN PROGRESS IS
INTENDED TO INFORM OUR
COMMUNICATION ACROSS THE
DIVISION.
IT'S NOT SPECIFIC TO MEDICATIONS
IN PREGNANCY BUT THERE'S A
COMPONENT OF THAT.
THE ACTUAL END PRODUCT RIGHT NOW
IS HIGH-LEVEL FINDINGS AND
DEVELOPMENT OF COMMUNICATION
PLAN TO BETTER HELP US BE MORE
EFFECTIVE IN OUR COMMUNICATIONS
ABOUT ALL OF OUR TOPICS BUT WE'D
BE HAPPY TO SHARE ANYTHING WE DO
FIND.
>> I SEE COMMENTS IN THE CHAT
BUT I CAN'T TELL IF THERE'S A
QUALIFYING QUESTION.
HOW MUCH IS A.I. IN CHAT BEING
USED FOR THE WEBSITE?
IS THAT BEFORE?
WONDERFUL.
KARA, THANK YOU VERY MUCH.
WE APPRECIATE YOUR WILLINGNESS
TO PROVIDE THE CLARIFICATION
QUESTIONS.
AND GIVE THE QUESTION TO TINA.
>> THANK YOU SO MUCH.
IT'S NICE TO FOLLOW KARA.
I'M GOING TALK ABOUT MOTHER TO
BABY AND SOME ARE FAMILIAR AND
SOME NOT.
I'LL GIVE SOME BACKGROUND
INFORMATION.
SO MOTHER TO BABY INFORMATION
SERVICE IS WHAT THIS WAS FOUNDED
AS AND THIS IS AN INITIATIVE
THAT PROVIDES EVIDENCE-BASED
INFORMATION ON CURRENT DATA
REGARDING THE BENEFIT OR RISK OF
MEDICATIONS AND OTHER EXPOSURES
DURING PREGNANCY OR DURING
LACTATION IN ADDITION TO
MEDICATIONS WE PROVIDE
INFORMATION ON VACCINES,
CHEMICAL, PESTICIDES, HERBAL
PRODUCTS, DIETARY SUPPLEMENTS,
SUBSTANCE AND MATERNAL HEALTH
CONDITIONS.
FROM THE BEGINNING, THESE
SERVICES HAVE BEEN PROVIDED AT
NO COST TO THE RECIPIENT WHOEVER
IS ACCESSING THESE AND THEY'RE
AVAILABLE IN ENGLISH AND
SPANISH.
THE SERVICES, THE FIRST OF THESE
WAS FIRST ESTABLISHED IN THE
1980s.
AND THERE'S NOW 14 SERVICES THAT
SERVE RESIDENTS IN ALL 50 STATES
AND TERRITORIES THROUGH A
NATIONAL ROUTING SYSTEM.
IF SOMEBODY CONTACTS US FROM
INDIANA THEY'LL BE MAYBE ROUTED
TO THE NEBRASKA SERVICE AND FROM
HAWAI'I TO THE CALIFORNIA
SERVICE.
THEY'RE STAFFED VARIABLY SOME BY
COUNSELORS, NURSES, HEALTH
EDUCATORS AND EACH OF THE
SERVICES HAS TO HAVE AN
IDENTIFIED MEDICAL DIRECTOR.
THE FUNDING FOR THESE VARIES BY
STATE.
SO STATE AND LOCAL RESOURCES
FUND SOME OF THE SERVICES SO FOR
EXAMPLE OUR SERVICE IN
CALIFORNIA IS PRIMARILY FUNDED
BY THE STATE DEPARTMENT OF
EDUCATION THROUGH THE UNIVERSITY
OF CALIFORNIA BUT ACROSS THE
NETWORK WE HAVE BEEN FUNDED FOR
THE LAST EIGHT YEARS IN PART BY
HRSA MATERNAL CHILD HEALTH
BRANCH AND IN THE LAST YEAR WE
HAVE RECEIVED DIRECT FUNDING
AWARD FROM CDC.
ON AVERAGE WE TAKE ABOUT 35 TO
40,000 QUERIES ANNUALLY.
OF THESE, ON AVERAGE ABOUT 80%
COME DIRECTLY FROM CONSUMERS.
SO PREGNANT AND LACTATING
PERSONS OR THE PUBLIC WITH
QUESTIONS ABOUT PREGNANCY AND
LACTATING EXPOSURES.
ABOUT 20% COME DIRECTLY HEALTH
CARE PROVIDERS IT CAN BEING A
PROVIDER WITH A PATIENT COMING
IN THAT AFTERNOON AND KNOW
THEY'LL HAVE TO TALK TO THEM
ABOUT OPTIONS IN TERMS OF
MEDICATIONS AND WANT TO GET
UPDATED INFORMATION ON WHAT
MIGHT BE AVAILABLE ON THE
VARIOUS OPTIONS.
WE GET CALLED FROM GENETIC
COUNSELORS WANTING TO GET
INFORMATION ON MEDICATION BEFORE
THEY TALK TO A PATIENT DURING A
VISIT.
WE ALSO TAKE CALLS ABOUT
LACTATION AND ABOUT 30% OF THE
CONTACTS INCLUDE A QUESTION
ABOUT LACTATION OR PREGNANCY AND
LACTATION COMBINATION CALL.
WHEN THE SERVICES WERE FIRST
STARTED THEY WERE ALL PROVIDED
BY TELEPHONE WITH SOME IN PERSON
CONSULTATION.
THIS HAS FLIPPED DRAMATICALLY IN
THE LAST SEVERAL YEARS.
NOW 27% OF SESSIONS ARE
CONDUCTED BY E-MAIL.
THE PREDOMINANT METHOD IS NOW
CHAT AND.
LAR AND MAKE IT POSSIBLE TO HAVE
AN INTERACTION WITH THE
PARTICIPANT BUT NOTHING WE'RE
DOING ON TELEPHONE OR IN PERSON.
WE OFFER A TEXT OPTION WHICH HAS
LIMITED CHARACTERS.
THAT'S USED LESS FREQUENTLY BY
7% AND WE STILL GET A QUARTER OF
OUR CONTACTS BY TELEPHONE.
I SHOULD SAY IN EACH OPTIONS
WHETHER E-MAIL, LIVE CHAT OR
TEXT, IF THE EXPOSURE THAT'S
BEING QUERIED ABOUT IS ONE THAT
CARRIES HIGH RISK OR IS
COMPLICATED IT'S ALWAYS OFFERED
TO THE PERSON WHO IS CONTACTING
IT BE CONVERTED TO A TELEPHONE
CONTACT BECAUSE IN THE COMPLEX
SITUATIONS IT'S DIFFICULT TO
HAVE A CONVERSATION AND BACK AND
FORTH EXCHANGE YOU NEED TO HAVE
AND CLARIFY THE LEVEL OF
UNDERSTANDING WITHOUT DOING IT
OVER THE TELEPHONE.
WE HAVE PARTNERED WITH CDC ON
MULTIPLE PUBLIC HEALTH URGENT
SITUATI
SITUATIONS GOING BACK TO
HURRICANE KATRINA FOR
INDIVIDUALS WHO MAY HAVE HAD
UNIQUE EXPOSURES DURING
PREGNANCY.
DURING ZIKA PARTNERED WITH THE
CDC WITH MARCH OF DIMES TO
PROVIDE UP TO DATE INFORMATION
AS IT WAS EVOLVING.
AND RECENTLY WITH COVID AND
COVID-19 VACCINES AND AS WE
ENTERED INTO VACCINES BEING
AVAILABLE, THE CDC PROACTIVELY
PARTNERED WITH US TO NAME
ANOTHER BABY AS A RESOURCE TO
PROVIDE INFORMATION ABOUT
PREGNANCY AND BREASTFEEDING WITH
A PARTNERSHIP THROUGH THE
AMERICAN ACADEMY OF PEDIATRICS
WAS A HUGE INFLUX OF CONTACTS
AND WE TALLIED MORE THAN 16,000
INDIVIDUALS ABOUT COVID VACCINES
AND INFECTIONS SINCE THE
PARTNERSHIP STARTED.
AS KARA MENTIONED WE HAVE FACT
SHEETS.
THIS IS A WAY OF EXTENDING THE
REACH PRIMARILY TO CONSUMERS TO
PREGNANT OR LACTATING PERSONS OR
PEOPLE CONSIDERING THAT
SITUATION.
THESE ANSWER FREQUENTLY ASKED
QUESTIONS ABOUT MANY COMMON
EXPOSURES DURING PREGNANCY AND
BREASTFEEDING AND FREE TO VIEW
AND DOWNLOAD AND WRITTEN BY A
DESIGNATED SPECIALIST WITHIN OUR
NETWORK AND REVIEWED AND UPDATED
AT LEAST ANNUALLY.
OVER THE LAST SEVERAL YEARS
WE'VE HAD A PARTNERSHIP WITH THE
NATIONAL LIBRARY OF MEDICINE AND
THEY HOST ALL OF OUR FACT SHEETS
ON THE WEBSITE AS WELL.
YOU CAN SEE HERE THESE ARE
PRETTY SIMPLE.
THEY'RE SINGLE PAGE TWO-SIDED
WITH THE SAME QUESTIONS ON EACH
ONE AND ANSWERED IN SIMPLE TERMS
WITH BLANK 2 REFERENCES.
WE HAVE OVER 500 FACT SHEETS
AVAILABLE ON A VARIETY OF
EXPOSURES INCLUDING VACCINES AND
MEDICATIONS, OCCUPATIONAL
HAZARDS, INFECTIONS AND HERBAL
SUPPLEMENTS.
THEY'RE ALL AVAILABLE IN ENGLISH
AND SPANISH AND WE HAVE SOME
AVAILABLE IN FRENCH AND HAVE
SERVICES IN CANADA AS WELL AND
IN 2022 ABOUT 4 MILLION TIMES
THE FACT SHEETS HAVE BEEN VIEWED
OR DOWNLOADED.
WE BRING THEM LINKS TO
PROFESSIONAL MEETINGS AS WELL
AND HEALTH CARE PROVIDERS
UTILIZE THESE WIDELY.
AS KARA MENTIONED WE HAVE
PODCASTS.
THESE GIVE LISTENERS INSIGHTS
INTO THE SAFETY AND EXPOSURES A
PREGNANT OR LACTATING PERSON MAY
EXPERIENCE.
THE PERSON WHO LEADS THE EFFORTS
IS CHRIS STALMAN WHO LOVE THIS
AND IS A GENETIC COUNSELOR FROM
OUR ARIZONA SERVICE.
AND TOPICS ARE NOMINATED AND
SELECTED FOR THESE PODCASTS AND
OFTEN TIMES INCLUDE INTERVIEWS
WITH KEY OPINION LEADERS AND
TOPIC AREA SPECIALISTS WHO CHRIS
HOSTS AND INTERVIEWS ON THE
PODCAST.
WE LAUNCHED THE FIRST IN 2017 SO
WE'RE NOW IN OUR FIFTH SEASON
AND AS OF MARCH OF THIS YEAR
THERE'S 57 PUBLISHED EPISODES
AND WE CATALOGED ABOUT 35,000
UNIQUE DOWNLOADS OF THE PODCAST
SESSIONS.
EXAMPLES OF RECENT TOPICS
INCLUDE RSV VACCINE, THE NEW
WEIGHT LOSS MEDICATIONS,
CANNABIS, MATERNAL HEALTH AND
COVID-19 IN PREGNANCY AND HIV
AND BREASTFEEDING.
BLOGS IS ANOTHER METHOD OF
COMMUNICATING DIRECTLY TO
CONSUMERS.
THESE ARE MORE CONVERSATIONAL,
PRACTICAL INFORMATION TO TARGET
AUDIENCE IN THE GENERAL PUBLIC.
THEY'RE WRITTEN BY OUR INTERNAL
INFLUENCERS OF ROTATING STAFF OF
MOTHER TO BABY EXPERTS AND
PUBLISHED MONTHLY TO OUR WEBSITE
IN ENGLISH AND SPANISH AND
HERE'S AN EXAMPLE OF ONE THAT
CAME OUT IN FEBRUARY OF THIS
YEAR LOOKING AT HYPERTENSION.
IN TERMS OF LACTATION AS YOU ALL
PROBABLY KNOW, PHIL ANDERSON AND
JASON SOBRON AUTHORED A RESOURCE
INFORMATION ON SAFETY OF
MEDICATIONS AND OTHER EXPOSURES
DURING LACTATION.
NICHD SPONSORS OR HOSTS THE
NATIONAL LIBRARY OF MEDICINE
PROVIDED ON THE WEBSITE HOWEVER
NATIONAL LIBRARY OF MEDICINE
DETERMINE THE APP WITH LACTRX
THEY'D NO LONGER SUPPORT AND
DR. ANDERSON CAME TO US BECAUSE
HE SAID IT WAS WIDELY USED AND
HE WAS CONCERNED THERE WOULD BE
LESS UPTAKE OF USE OF LACTRX IF
THE APP WAS NOT AVAILABLE AND WE
AGREED TO TAKE THIS ON AND
NEGOTIATED WITH THE NATIONAL
LIBRARY OF MEDICINE WHO SAID
THEY'D BE FINE IF WE MIRRORED
WHAT WAS ON THE NATIONAL LIBRARY
OF MEDICINE AND RATHER THAN GO
THROUGH THE WHOLE LICENSING
ISSUE OF THE NAME AGREED WE
COULD CHANGE THE NAME TO LACTRX
BY MOTHER TO BABY.
THE APP IS NOW LACTRX BY ANOTHER
BABY AND FREE ACCESS TO
EVERYTHING IN LACTRX AS IT
APPEARS THERE FOR CURRENT
INFORMATION ON MEDICATIONS,
SUBSTANCE AND OTHER EXPOSURES
DURING LACTATION.
WE MONITOR METRICS AND HAVE
16,000 NEW USERS AND ABOUT 80%
OF NEW USERS ENGAGE IN THE
SESSION WITH AN AVERAGE
ENGAGEMENT TIME OF ABOUT SIX
MINUTES PER SESSION.
THE MAJORITY ARE FROM THE UNITED
STATES BUT THE UPTAKE OF THE APP
IS WORLDWIDE AND SEE THE
DISTRIBUTION BY COUNTRY ON THE
MAP HERE.
WE ALSO PARTNER DIRECTLY WITH
CLINICIANS AND HERE'S ONE
EXAMPLE.
HRSA HAS ESTABLISHED A NATIONAL
MATERNAL MENTAL HEALTH HOT LINE
WHICH IS STAFFED BY MENTAL
HEALTH PROFESSIONALS TO INTERACT
WITH TEAM WHO MAY BE HAVING
DIFFICULTIES WITH MENTAL HEALTH
DURING PREGNANCY.
WE HAVE PARTNERED WITH THEM AND
HAVE ESTABLISHED A PROCESS
WHEREBY THE MENTAL HEALTH HOT
LINE PROVIDERS CAN WARM TRANSFER
CLIENTS THEY HAD CONTACT WITH TO
MOTHER TO BABY ABOUT INFORMATION
ON MEDICATIONS THEY MAY BE
TAKING OR CONSIDERING USING IN
TERM OF SAFETY IN PREGNANCY AND
LACTATION.
AS YOU HEARD WE PARTNER WITH
SFMF.
THEY'VE AGREED TO DISTRIBUTE NEW
AND UPDATED FACT SHEETS TO
MEMBER CLINICIANS VIA THE
ORGANIZATION'S NEWSLETTER.
TAT A MECHANISM FOR GETTING THAT
OUT TO PROVIDERS AND WORK WITH
ACOG, CDC AND DOING ONE ON
CONGENITAL SYPHILIS AND WE HAVE
A COURSE AND SOME MAY REMEMBER
THIS WAS STARTED BY MASS GENERAL
MANY YEARS AGO AND IS THE ONLY
COURSE AVAILABLE TO TRAIN
UNDERSTANDING HOW TO EVALUATE
AND IDENTIFY INFORMATION
AVAILABLE IN THAT FIELD OF
TERATOGENS AND THEY NOW OFFER IT
AS A LIVE VIRTUAL COURSE EVERY
OTHER YEAR.
IT'S HEADED BY A MATERNAL FETAL
EXPERT AND CONTINUING EDUCATION
CREDITS ARE OFFERED TO PROVIDERS
AND IT'S BEEN WITH THIS VIRTUAL
OPTION PLUS IN PERSON.
IT'S BEEN VERY POPULAR.
WE HAVE HAD ATTENDEES FROM 22
COUNTRIES.
I WON'T TALK ABOUT THE ASPECT
BUT MOTHER TO BABY HAS A
RESEARCH ARM SO PREGNANCY
STUDIES STARTED BACK IN THE
EARLY 2000s, IT'S A RESEARCH
PROGRAM SEEKING TO UNDERSTAND
HOW CERTAIN MEDICATIONS,
VACCINES AFFECT OUTCOMES AND
RECRUITED CALIFORNIA SAN DIEGO
AND RECRUITED INDIVIDUALS AND
CAPTURED INFORMATION FROM
TELEPHONE INTERVIEWS AND MEDICAL
REPORTS AND A PEDIATRIC
EXAMINATION FOR LIVE BORN
INFANTS AND WE PARTNER WITH
SPECIALTY PROVIDERS AND OBs TO
MAKE THOSE REFERRALS AND IT
WORKS FULL CIRCLE.
OUR INFORMATION SERVICES REFER
INDIVIDUALS WHO MAY BE
INTERESTED AND ELIGIBLE FOR
PREGNANCY STUDIES INTO STUDIES
AND THE INFORMATION GENERATED
FROM THESE IS RETURNED BACK TO
PROVIDE TO PROVIDERS AND WE'RE
CAPTURING SAMPLES AND DATA ABOUT
EXPOSURES DURING LACTATION OVER
THE COURSE OF TIME A MOTHER MAY
BE BREASTFEEDING.
I'LL END THERE.
THANK YOU.
>> THANK YOU VERY MUCH, TINA FOR
COVERING THE BREADTH OF
ACTIVITIES IN MOTHER TO BABY.
ANY CLARIFYING QUESTIONS BEFORE
WE GO INTO THE BROADER
DISCUSSION.
KATHERINE?
>> I HAVE A QUICK QUESTION AS
YOU TALK ABOUT AND MAYBE THIS
LAS PLEASE TO CDC.
AS YOU THINK ABOUT ENGAGING WITH
HEALTH CARE PROVIDERS YOU
MENTIONED ACOG AND SMFM ARE YOU
WORKING WITH THE NURSE
PRACTITIONERS AND OTHER FOLKS
WHO MAY BE ENGAGING WITH THESE
POPULATIONS AS WELL?
>> WE'VE HAD PARTNERS WITH A1
AND NURSE MIDWIVES AND THE
NATIONAL OFFICE FOR MOTHER TO
BABY HAS A PRETTY EXTENSIVE
PROGRAM OF ENGAGING WITH
DIFFERENT TYPES OF PROVIDERS
THAT MIGHT BE IN THE OBSTETRIC
OR BREASTFEEDING SPACE.
>> WE HAVE A LONG STANDING
RELATIONSHIP IN ALCOHOL WORK AND
WORKING ON A BROADER ENGAGEMENT
WITH THIS GROUP.
>> RACHEL.
>> LONG THE SAME LINES AND SINCE
THERE'S MENTION OF CONGENITAL
SYPHILIS AND SOME OF THE OTHER
EMERGING THINGS AND I'M THINKING
OF RSV AS WELL AND THE ROLLOUT
IF THERE'S BEEN WORK WITH THE
PHARMACY GROUPS.
I KNOW THAT CAME UP IN THE LAST
WE HEARD WITH RSV SEASON AND
OPTIONS AVAILABLE DURING
PREGNANCY THERE WERE SOME
PHARMACISTS THAT REFUSED TO
VACCINE PREGNANT PATIENTS AND
ADMINISTERED THE WRONG VACCINE
AND PEOPLE HAVE SAID WOW, ARE
YOUR MEMBERS NOT GETTING THIS
AND WHY IS THIS HAPPENING?
IN THE OB-GYN OFFICE IT WOULD
NOT HAPPEN AND THERE WERE
BARRIERS TO HAPPENING IN THE
OFFICE AND EXTENDING THAT
QUESTION TO NOT JUST OB-GYN BUT
THE PHARMACISTS AS WELL.
>> I COULD SAY YES I AGREE 100%
PHARMACISTS ARE THE FRONT LINE
CLINICIANS THAT NEED TO HAVE
THIS INFORMATION AND WE -- I
TEACH A COURSE IN THE SCHOOL OF
PHARMACY AND NOW TAKING IT
STATEWIDE BECAUSE SO FEW GET
TRAINING IN THAT.
WE'VE BEEN FORTUNATE WITH MOTHER
TO BABY THAT JERRY BRIGGS WHO IS
A PHARMACIST HAS ALWAYS BEEN AN
ADVOCACY FOR US EXHIBITING AND
DOING PRESENTATIONS AT THE MAJOR
PHARMACY MEETINGS SO IT'S BEEN
AN AVENUE FOR TRYING TO EDUCATE
AS WELL.
>> OUR GROUP DOES NOT HAVE A
VERY CLOSE COLLABORATION WITH
PHARMACEUTICAL GROUPS BUT THE
IMMUNIZING AND THE GROUPS
DESCRIBED.
>> I WAS WONDERING, JULIE
SPEAKING, WHAT YOUR OUTREACH HAS
BEEN TO THE LACTATION
PROFESSIONALS?
THIS IS ALL NEW TO ME AND WE'RE
ALWAYS LOOK OUT FOR PLACES TO
SEND CLIENTS REGARDING
INFORMATION ON THAT SO I JUST
TEXTED ALL MY COLLEAGUES TO GO
TO ALL THE CONFERENCES AND
WHAT'S BEEN THE OUTREACH THERE?
>> JULIE, THANK YOU FOR SAYING
THAT.
I THINK IT'S A HUGE OPPORTUNITY
AND WE'RE JUST SORT OF VENTURING
INTO THAT NOW.
GOING BACK TO THE LACTRX APP, I
KNOW THAT WAS WIDELY USED.
THERE'S A LITTLE BIT OF
CONFUSION ON THE COMMUNICATION
BECAUSE SOME PEOPLE THINK LACTRX
STILL EXISTS AND NOT UPDATED AND
DON'T UNDERSTAND LACTRX REPLACED
IT.
WE'RE LOOKING THROUGH ACADEMY OF
BREASTFEEDING MEDICINE TO GET
THE INFORMATION OUT.
I THINK WE CAN DO MORE ABOUT
LACTATION CONSULTANTS GETTING
INFORMATION WHERE THEY CAN GO TO
GET THIS INFORMATION.
>> I WONDER IF WE CAN GET YOU TO
OPINE A LITTLE BIT GIVEN YOU DO
WORK AN ACROSS RECOMMENDATION 5
AND 6 AND AS WE THINK ABOUT THE
TOP LINE OF RECOMMENDATION 5 OF
PUBLIC AWARENESS CAMPAIGN BEYOND
WHAT MOTHER TO BABY IS DOING.
I WONDER IF YOU HAVE ME HIGH
LEVEL THOUGHTS AS THE EXPERT
AROUND WHAT THAT COULD LOOK LIKE
AND WHAT'S MISSING AS WE THINK
ABOUT THE RECOMMENDATION.
>> I THINK IT CROSSES OVER TO
WHAT KARA SAID.
I LOOK AT PUBLIC AWARENESS AND
IF A FRACTION OF PEOPLE WHO ARE
PREGNANT OR LACTATING IN ANY
GIVEN YEAR ARE ACTUALLY
CONTACTING US, HOW AWARE IS THE
PUBLIC OF TAKING ADVANTAGE OF
THESE SERVICES.
AND AS KARA MADE THE CASE, IT'S
NOT LIKE .01% OF PEOPLE HAVE
QUESTIONS AND CONCERNS AND ARE
MAYBE NOT -- DON'T KNOW WHERE TO
GO.
I THINK WE COULD DO A MUCH
BETTER JOB IN A PUBLIC AWARENESS
CAMPAIGN OF MAKING THE CASE THAT
THIS INFORMATION TA WE KNOW
PEOPLE WANT TO HAVE IS AVAILABLE
AND HOW TO ACCESS IT.
>> THANK YOU.
HOLD ONE SECOND.
I THINK BECKY YOU NICELY
TRANSITIONED US TO THE BROADER
DISCUSSION SO I THINK WE CAN
WELCOME ALL OTHER QUESTIONS TO
THE BROADER DISCUSSION.
THE TOPIC OF THE PUBLIC
AWARENESS CAMPAIGNS.
>> APOLOGIES BECAUSE I DIDN'T
INTRODUCE MYSELF, CARDINAL RULE
BROKEN THERE.
I'M WITH THE PREECLAMPSIA
FOUNDATION.
YOU'RE THE ONE I UNDERSTAND
BEST.
THANK YOU.
WHILE I KNOW IT WASN'T
NECESSARILY A BUSINESS ANALYSIS
PRESENTATION, IN OUR EVALUATING
WHAT CAN YOU SAY ABOUT OTHER
SIMILAR SERVICES, IE COMPETITORS
TO THIS THAT ARE PROVIDING
SIMILAR SERVICES.
WHAT'S THE FIELD OUT THERE
BEYOND THIS MOTHER TO BABY
SERVICE?
>> THAT'S A GOOD QUESTION.
I THINK IT'S COLLABORATIVE.
I THINK CDC IS VERY MUCH OUR
PUBLIC FACING PARTNER IN TERMS
OF GETTING INFORMATION LIKE KARA
DESCRIBED THAT PEOPLE WILL
PRIMARILY ACCESS THROUGH THE
WEBSITE.
CDC IS I THINK LONG AGO DECIDED
THEY WERE NOT GOING TO BE
ANSWERING THE TELEPHONE FOR
PEOPLE WHO WANTED TO ASK
QUESTIONS ABOUT X, Y OR Z AND
THERE'S BEEN OTHER INITIATIVES
LIKE TEXT FOR BABY AS WAYS TO
GET INFORMATION TO CONSUMERS.
THERE'S A COUPLE COMMERCIAL
THINGS.
THERE WAS AN NICHD INITIATIVE
FOR A WHILE.
I DON'T REALLY SEE ANOTHER KIND
OF COMPETITIVE BROAD BASED
INITIATIVE THAT DOES WHAT MOTHER
TO BABY DOES.
>> I'M WITH THE CDC.
IT PUTS INFORMATION SERVICE NOT
ONLY IN THE U.S. BUT THE OUTWARD
FACING MOTHER TO BABY AND
INTERNATIONALLY, THOSE ARE THE
PEOPLE THAT FOLKS CALL WHEN THEY
HAVE QUESTIONS ABOUT MEDICATIONS
DURING PREGNANCY.
I DON'T THINK THERE'S A LOT OF
OTHER ORGANIZATIONS OUT THERE
THAT DO IT.
WE KNOW ABOUT MAP GENERATION AND
IT'S BEING ADDRESSED AND
HOPEFULLY IN THE RECOMMENDATIONS
BUT HOW CAN WHAT ARE SOME OF THE
PIECES AND THIS FOR EVERYONE
AROUND THE ROOM AND NOT
NECESSARILY JUST KARA AND TINA
BUT WHERE DO WE THINK THERE ARE
IDENTIFIED GAPS IN BRINGING ALL
THE STAKEHOLDERS TO THE TABLE?
WE HAVE A SPONSOR NEGOTIATING
WITH THE AGENCY AND APPROVE A
LABEL INCLUDING PATIENT
INFORMATION WHAT'S NECESSARY AND
SPAM.
MOU ARE THERE POTENTIAL GAPS WE
MIGHT NEED TO ADDRESS IN OUR
REPORT TO CONGRESS TO HELP
BETTER FACILITATE HOW THE
INFORMATION IS ULTIMATE ABLE TO
BE COMMUNICATED?
ANY THOUGHTS FROM ANYONE.
THERE'S CONNECTIVITY BETWEEN
PROVIDERS AND TALKING ABOUT
PHARMACISTS BUT THE CONNECTION
BETWEEN THE SPECIALISTS THAT
TREAT THE DISEASE BEING TREATED.
WITH THE OB-GYN AND PHARMACIST
WHO HANDS OVER THE MEDICATION.
THAT CONNECTION IS NOT ALWAYS
THERE TO THE EXTENT WE'D LIKE TO
SEE IT.
HOW TO FACILITATE IT I DON'T
HAVE A GOOD IDEA FOR RIGHT NOW
BUT I DO THINK THAT'S SOMETHING
THAT IS IT STILL TO BE IMPROVED.
YOU GO TO A RHEUMATOLOGIST AND
THEY SEND THEM TO THE OB IT'S
NOT MY JOB AND IT'S IDENTIFYING
A GROUP OF 10 OR SO
RHEUMATOLOGISTS WHO CARRY THE
FLAG FOR REPRODUCTIVE HEALTH AND
THEY'RE MOTIVATE AND INTERESTED
AND OPINION LEADERS AND CARRY
THE INITIATIVE FORWARD FOR
EVERYBODY ELSE IT. TAKES THAT
GROUP THAT HAS SPECIAL INTEREST
AND THE SPECIALTY PROVIDERS TO
MAKE THAT CONNECTION AND
INITIATE WAYS TO DO THAT.
THE OTHER ONE WHERE THERE'S A
GAP IS BETWEEN OBs AND
PEDIATRICIANS.
THE WHOLE THING ABOUT LACTATION,
THE OB IS THE PERSON WHO SHOULD
BE DISCUSSING THE LACTATION
QUESTION BEFORE THE PERSON EVER
DELIVERS AND THEN WE HAVE THE
GAP ON THE PEDIATRIC SIDE WHERE
IT'S NOT RECORDED IN E.H.R.
BECAUSE THE MOTHER'S TAKING THE
MEDICATION NOT THE BABY.
AND THE CONNECTION BETWEEN
PEDIATRICIANS AND OB'S
IMPORTANT.
>> I THINK IT'S AN INTERESTING
AND COMPLICATED QUESTION.
I THINK WE HAD A LOT OF OPTIMISM
AND EXCITEMENT WHEN THE
REGULATION CAME OUT SWITCHING
FROM THE LETTERS TO THE
EXPLANATORY STATEMENT AND HEARD
FROM MEMBERS WHO WERE CHALLENGED
BY THAT.
IT WAS A SIMPLER STRAIGHTFORWARD
CONVERSATION AND I THINK EASILY
DIGESTIBLE AND SAY HAS A LETTER
AND THAT WAS AN EASIER
CONVERSATION OR START OF
CONVERSATION WITH OUR PATIENTS
AND NOW OF COURSE IT'S A BIT
DIFFERENT WITH THE PACKAGING.
THERE CONTINUES TO BE POTENTIAL
BUT IT'S A MORE COMPLICATED
CONVERSATION ESPECIALLY WHEN THE
PHYSICIANS OR THERE'S NOT A LOT
OF TIME WITH EACH PATIENT AND
CAN'T TAKE THE TIME TO DIG INTO
WHAT'S AVAILABLE OR NOT.
I THINK THAT WILL CONTINUE TO BE
CHALLENGING AN I SEE IT AS AN
ONGOING CHALLENGE WHICH IS WHAT
YOU'RE TALKING ABOUT BUT DON'T
KNOW HOW TO GET PAST THAT
WITHOUT HAVING MORE OF THAT
INFORMATION.
IT CONTINUES TO BE DIFFICULT.
>> THANK YOU.
JEN.
>> I WANTED TO CIRCLE BACK TO
ADDING TO THE CONVERSATION TO
TIE INTO THE COMMUNICATION
BETWEEN SPECIALIST AND OB-GYN
AND THE THOUGHT DISEASE BASED
REGISTRIES CAN BE HELPFUL FOR
SAFETY AND THERE'S BASICALLY RUN
WITH SPECIALIST AND THERE'S NOT
A LOT OF COMMUNICATION WITH
OB-GYNs AND A COMMUNICATION GAP
WHERE THE PATIENT IS EXPECTED TO
BRING THE INFORMATION OVER AND
THAT'S IN MY VIEW PROBLEMATIC.
>> I WANTED TO BRING OUT THE
QUESTION HIGHLIGHTED IN 5A WHERE
THE FOCUS NOT SOLELY INTENDED TO
BE JUST ON THE RISK OF
MEDICATION USE IN PREGNANCY BUT
THE RISK OF NOT USING A
MEDICATION IN PREGNANCY.
DO WE FEEL THE COMMUNICATION
STRATEGIES ARE ADEQUATELY BOTH
COMPONENTS?
DOES ANYBODY WANT TO SPEAK THAT?
>> THIS IS ALISA HURLEY AND
WANTED TO ASK A QUESTION ABOUT
THAT.
WHEN SOMEBODY CALLS OR TEXTS THE
HELP LINE HOW MUCH OF THAT
CONVERSATION IS ASSESSING
RELATIVE RISK OR THE RISK OF
EXPOSURE OPPOSED TO NOT TAKING
IT AND WHATEVER IT IS.
>> IT'S EQUALLY WEIGHTED.
IT'S VERY MUCH A PART OF IT.
I WORRY THE CLINICIAN OR PATIENT
DOESN'T READ DOWN TO THE PART
AND NEEDS TO BE PART OF THE SAME
CONVERSATION TAKEN IN THE SAME
BREADTH.
IT'S PART OF THE CONVERSATION
WHEN YOU TALK ABOUT A VACCINE
BUT IT'S ABSOLUTELY THE PART
YOU'RE TALKING ABOUT AN ASTHMA
MEDICATION OR CYCLOMEDICATION.
>> HOW MANY FOLKS THAT HAVE
CALLED IN HAVE SPOKEN TO THEIR
PROVIDER ALREADY ABOUT THE ISSUE
WHETHER IT'S THE RISK OF TAKING
A DRUG OR THE RISK ARE OF GOING
OFF A DRUG DURING PREGNANCY?
>> I WON'T BE ABLE TO GIVE
CONCRETE NUMBERS BUT THEY COME
DIFFERENT PATHWAYS OFTEN IT'S I
READ THIS ON THE INTERNET OR
READ THIS IS HARMFUL IN RATS OR
MY SISTER TOLD ME SUCH AND SUCH.
SOMETIMES IT'S THEY TALKED TO
THEIR PROVIDER AND THEY'RE
WANTING REASSURING INFORMATION.
WE ALWAYS SAY THE INFORMATION WE
PROVIDE YOU TO YOUR PROVIDER AND
TALK TO THEM ABOUT IT.
WE'RE NOT PROVIDING MEDICAL
CARE.
IT'S AN INFORMATION SERVICE
ONLY.
AND THE INFORMATION WE PROVIDE
YOU WE ENCOURAGE YOU TO TAKE TO
YOUR PROVIDER AND IF YOU'RE
PROVIDER HAS QUESTIONS TO COME
BACK AND ASK US WHICH DOES
HAPPEN.
>> THERE'S ONE THING IT'S A
VACCINE OR PSYCHO THERAPEUTIC
AND HERE'S THE RISK BENEFIT BUT
I WONDER IF THERE'S A LIST OR
COMMONLY USED GROUP OF MEDS THAT
WE DON'T ACTUALLY HAVE SO MUCH
GUIDELINES ON AND NO ONE KNOWS
WHAT TO DO THAT WE COULD DIRECT
RESOURCES TO DISSEMINATE THOSE.
AS MUCH AS THE INFORMATION THAT
IS KNOW I WONDER THE GAPS AND WE
DON'T TALK BIT AT ALL.
>> I DON'T WANT TO PUT CAMILLE
ON THE SPOT BUT AARON OR CAMILLE
TALK ABOUT THE PRIORITIZATION
LISTS.
>> DISCUSS THE REQUEST FOR
LABELS FOR RESEARCH.
WE RECEIVE ABOUT 136 NOMINATIONS
IN THE FALL AND WE ARE GOING TO
BE ORGANIZING THOSE NOMINATIONS
AND GATHERING FEEDBACK AND
COLLECTING FEEDBACK FROM
STAKEHOLDERS AT A FUTURE MEETING
LATER THIS SUMMER, ACTUALLY.
WE'LL BE HAPPY TO SHARE
INFORMATION WITH THIS GROUP WHEN
IT BECOMES AVAILABLE.
>> THANK YOU FOR LETTING ME PUT
YOU ON THE SHOT.
>> ALSO WANTED TO ADD THE TWO
SOURCES OF INFORMATION ON OVER
THE COUNTER MEDICATION THE
NATIONAL BIRTH DEFECTS
PREVENTION STUDY WHICH CAPTURES
INFORMATION ON OVER THE COUNTER
USE AND PREGNANCY REGISTRIES WE
DO WE CAPTURE INFORMATION AS
WELL.
SO A LOT OF THE INFORMATION ON
OUR FACT SHEETS ON ACETAMINOPHEN
AND OTHER COMMONLY USED
MEDICATIONS, THAT'S WHY DATA ON
THOSE COME FROM.
>> THANKS VERY MUCH FOR THOSE
PIECES.
ADJUST TO TRY AND SUMMARIZE
RECOMMENDATION 5 AND FOCUS ON
RECOMMENDATION 6.
WHAT WE HEARD CLEARLY IS THAT
THERE MAY BE MORE NEED FOR US TO
FOCUS SOME OF THE PUBLIC
AWARENESS ON THE RISKS OF NOT
TAKING MEDICATIONS IN PREGNANCY
AND LACK TAGE AND HELP THE
STAKEHOLDERS INVOLVE UNDERSTAND
WHY IT'S A CRITICAL COMPONENT OF
THE DISCUSSION.
OTHER PIECES AND OPPORTUNITIES
TO EXPAND THE CONVERSATIONS INTO
THE LACTATION EXPERT COMMUNITY
AND HOW TO STRENGTHEN THE
CONNECTIVITY BETWEEN STAKEHOLDER
GROUPS THAT HAVE A CONTEXT TROLL
GROUPS AND THERE APPEARS TO BE
PROGRESS MADE IN THE SPACE BUT
MORE TO BE DONE AND I SAW YOUR
HAND RAISED.
>> WE NEED TO CONTINUE TO
EDUCATE ON WHAT A RISK MEANS.
APPROPRIATE WHAT DOES IT MEAN
AND CONTINUING TO EDUCATE THE
PUBLIC BECAUSE THERE'S ONE CASE
OF SOMETHING AMONG THOSE THAT
HAVE TAKEN SOMETHING DOES NOT
MEAN -- AND
>> HOW PREGNANT WOMEN THINK
ABOUT RISK.
>> THAT'S PART OF THE WORK WE'RE
TRYING TO DO.
>> THAT TAKES US NICELY TO
RECOMMENDATION 6.
>> WE DIDN'T STUDY THE RISK OF
NOT BREASTFEEDING.
THAT'S THE LAST FEEDING.
I DON'T THINK WE'RE MAKING MUCH
PROGRESS THERE CONSIDERING WE
GET ENOUGH PUSHBACK OF THE RISK
INOCCURS GUILT AND DON'T WANT TO
TALK ABOUT IT AND THAT'S BEFORE
YOU ADD IN A MED.
YOU HAVE TO ADDRESS THAT PART
FIRST BEFORE YOU CAN GET IN THE
MEDICATIONS ASPECT.
>> THANK YOU, THAT'S IMPORTANT
CLARIFICATION.
>> MAKING THE TIE OF THE
INFORMATION WE HAVE FOR THE NEED
FOR RESEARCH IN THE AREA NEEDS
TO BE PART OF THE
COMMUNICATIONS.
>> TO UNDERSTAND THE MIND SET OF
RESEARCH PARTICIPATION.
>> WE HAVE THAT ON OUR WEBSITE
HIGHLIGHTING THERE'S NOT A LOT
KNOWN ABOUT VARIOUS MEDICATIONS
AND IF YOU WANT TO PARTICIPATE
HERE'S PLACES TO LOOK BUT WE CAN
MAKE THE CONNECTION MORE
SPECIFIC.
>> AND MORE ABOUT IN THE SURVEYS
THAT YOU'RE ASKING ACTUALLY --
>> AS WE WERE TALKING TODAY I
THOUGHT WE SHOULD ADD THAT AND
HOW TO FRAME IT TO ENCOURAGE
PEOPLE TO PARTICIPATE.
>> WE NEED TO UNDER SCORE THE
NUANCE ABOUT RISK WHICH IS TO
HAVE A PATIENT DEFINED RISK
THRESHO
THRESHOLDS DEFINE RISK AS AN
OUTCOME THAT'S PATIENT CENTER
AND INCORPORATE THAT TO FUTURE
RESEARCH.
AND THEN BRIDGE ADVANCEMENTS
WE'VE SEEN IN THE FAMILY
PLANNING RESEARCH SPACE INTO
SOME OF THE THINGS WE'RE TALKING
ABOUT IN TERMS OF OBSTETRIC AND
LACTATION PHARMACOLOGY.
THANK YOU.
>> THANK YOU, BECKY FROM SMFM.
I APPRECIATE THAT CONVERSATION
AND AS WE SCORE THE PARTS IN 5 I
WANT TO UNDER SCORE I DON'T WANT
US TO SAY NO RESEARCH IS NEEDED
BECAUSE KARA'S DOING SOMETHING
FOR COMMUNICATION.
THANK YOU FOR YOUR WORK, KARA,
BUT MORE NEEDS TO BE DONE.
>> I THINK I HEARD UNFUNDED.
>> THAT MAY BE A GOOD
OPPORTUNITY AS WE THINK ABOUT
THE BRIDGE BETWEEN FIVE AND SIX
AND THE DICHOTOMY OF WHAT THE
PUBLIC WAS AWARE OF AND MAKE THE
PUBLIC AWARE OF THINGS WHEN
MAYBE THE HEALTH CARE PROVIDERS
DON'T KNOW THE ANSWERS TO THE
QUESTIONS WHICH IS WHY WE'RE
HERE.
SO ONE OF THE AN ADDITION TO ALL
THIS NEEDS MORE FUNDING AND
NEEDS MORE DEDICATED FUNDING FOR
THE SPECIFIC ACTIVITIES.
ANYTIME WE SEE WE'RE LIKE
PULLING TOGETHER THE RESOURCES
THAT WE HAVE WHEN I HEAR THAT
FROM FEDERAL AGENCIES WE'RE
TAKING NOTES ON ALL THIS AND
THINKING WHAT DOES THIS MEAN.
THE CALL THERE NEEDS TO BE A
CALL TO ACTION TOO IN A LOT OF
THESE.
WITHIN A PUBLIC AWARENESS
CAMPAIGN WHAT'S THE CALL TO AC
TO THE AUDIENCE WE'RE TRYING TO
GET TO WITHIN STRATEGIES RELATED
TO HEALTH CARE PROVIDERS WHAT'S
THEIR CALL TO ACTION AND THIS
TIES TOO THE BROADER
CONVERSATION ABOUT WOMEN'S
HEALTH RESEARCH IN THE COUNTRY
RIGHT NOW IN PARTICULAR IN LIGHT
OF AN EXECUTIVE ORDER SIGNED ON
MONDAY THERE'S A LOT WE DON'T
KNOW AND IT'S STRUCTURAL THE
REASONS WE DON'T KNOW IT.
AND FIT INTO RESEARCH TRAINING
AND CURRICULUM WITHIN THE
BROADER WOMEN'S HEALTH CONTEXT.
IT SHOULDN'T BE SILOED IF YOU'RE
GOING TO HEAR ABOUT AUTO IMMUNE
CONDITIONS AND WHY THEY IMPACT
WOMEN MORE AND PEOPLE DON'T KNOW
THE ANSWERS SO IT'S ONE THING WE
HEAR ABOUT OUR PROGRAMS NOT
RELATED TO PREGNANCY.
WE HEAR IT IN LUPUS AND
NARCOLEPSY AND ANY ISSUE WE'RE
LOOKING AT THAT HEALTH CARE
PROVIDERS, THAT'S A PIECE OF IT
AND RESEARCH OBVIOUSLY AND THE
MORE PUBLIC AWARENESS SIDE
ALTOGETHER.
THERE'S DEFINITELY A CALL TO
ACTION IN TERMS OF HOW TO FIT
THIS INTO SOMETHING ALREADY
MOVING.
AND THEN ON THE ADVOCACY SIDE
THE DEDICATED FUNDING STREAM IS
SUPER IMPORTANT.
>> WHAT YOU SAID HAS BEEN
RESONATING WITH ME BECAUSE IT
HIGHLIGHTS WE NEED TO BE CLEAR
IN OUR REPORT THE
RECOMMENDATIONS ARE SO
INTERCONNECTED AND CAN'T LIVE
UNTO THEMSELVES THEY RELY ON
OTHER PIECES IN ORDER TO
CONTINUE TO GROW THE RESEARCH
COMMUNITY AROUND OUR ABILITY TO
GENERATE DATA TO BETTER INFORM
OUR PATIENTS HOW DO WE DO THAT
AND PUT THE PIECES TOGETHER.
>> AND PATIENT CENTEREDNESS AND
ENGAGEMENT AND THERE'S AREAS WE
CAN ALREADY PULL FROM
POTENTIALLY IF WE HAD THE
RESOURCES TO DO THAT BUT CLARITY
BECAUSE THAT'S WHAT'S GOING TO
MOVE THIS SIDE OF THE PROCESS.
>> I'D LIKE TO ADD ONE MORE
THING BASED ON ONE OF THE
PODCASTS FROM MOTHER TO BABY
ABOUT FOLIC ACID AND I WAS
LISTENING TO IT IN MY CAR AND
THINKING WHY ARE WE STILL
TALKING ABOUT FOLIC ACID.
I'VE BEEN TALKING ABOUT IT FOR
20 YEARS BUT THE COMMUNITY
CHANGES EVERY COUPLE YEARS AND
SO THIS IS NOT SOMETHING WHERE
WE CAN USE INFORMATION FROM 2018
BECAUSE THE WOMEN WE WANT IT
REACH NOW GREW UP AFTER COVID
ALREADY.
I THINK THAT IS AN IMPORTANT
ASPECT WE NEED TO REALIZE IS
WE'RE CONSTANTLY TALKING TO A
NEW GROUP OF WOMEN TO WHICH I NO
LONGER BELONG BUT THAT'S AN
IMPORTANT ASPECT TOO.
>> NOT ONLY BASED ON AGE BUT THE
EVOLVING DEMOGRAPHIC OF OUR
SOCIETY AS WELL.
>> AND HOW THEY'RE GETTING
INFORMATION AND WHERE NOW.
>> IT'S A LOT TO COORDINATE.
>> CAKARA, THE PRIORITIZATION O
WHERE MESSAGES MOST RESONATE AND
FAMILY AND FRIENDS IS IS RIGHT
AFTER PROVIDER.
IT CAN HAVE AN OUTSIZED IMPACT.
>> AND KIND OF WHAT WE WERE
TALKING ABOUT BUT WE ARE DOING
MORE FOCUS RESEARCH RIGHT NOW AS
WELL WITH HISPANIC COMMUNITIES
AROUND FOLIC ACID AND DEPENDING
ON WHO YOU'RE TALKING TO MAY
RELY MORE ON ADVICE FROM YOUR
GRANDMOTHER OR MOTHER AND
COMMUNICATING ALSO WITH THOSE IN
THEIR CLOSE CIRCLES.
>> IF I COULD JUST MAKE ONE MORE
COMMENT ABOUT THE BRIDGING TO
OTHER ISSUES.
SO I'M OVER SIMPLIFYING BECAUSE
OUR RESEARCH IS SUPER IMPORTANT
AND WILL CONTINUE TO BE SUPER
IMPORTANT AND PARSING OUT
EXACTLY WHAT THE MESSAGING
PROBLEMS ARE WE'RE HAVING BUT AS
A GENERALIZATION I THINK IF YOU
ASK THE PUBLIC AND THE TARGET
POPULATION HERE ABOUT
MEDICATIONS AND PREGNANCY THE
GENERAL BELIEF IS THAT PREGNANT
PEOPLE SHOULD NOT BE TAKING
MEDICATIONS AND THEIR PHYSICIANS
WILL SAY DON'T TAKE THESE
MEDICATIONS BECAUSE THEY BELIEVE
THE MEDICATIONS ARE KNOWN TO BE
BAD FOR THEM VERSUS WE JUST
DON'T KNOW.
THERE'S A DIFFERENCE VERSUS
SOMETHING WE DON'T KNOW IS BAD
AND DON'T KNOW AND TO THE PUBLIC
IT'S AN INTERPRETED AS DON'T
TAKE IT BECAUSE TAKING
MEDICATION IN PREGNANCY IS BAD.
THAT LINKS TO A COMMUNICATION
PROBLEM WE HAVE AND/OR ARE GOING
TO HAVE ABOUT DRUG DEVELOPMENT
FOR PREGNANCY COMPLICATIONS.
IT'S INCREASINGLY IN OUR
PREECLAMPSIA WORLD IS SOMETHING
WE'LL HAVE TO ADDRESS BECAUSE
THERE'S THERAPEUTICS BEING
DEVELOPED.
IF YOU LINK THE IDEA THERE'S A
PERVASIVE KNOWLEDGE THAT
MEDICATION IN PREGNANCY IS BAD
BECAUSE THE MEDICATIONS ARE BAD
AND NOW WE'RE GOING TO BE TRYING
TO INTRODUCE COMMUNICATIONS
AROUND NEW DRUG DEVELOPMENT AND
WHY IT'S IMPORTANT TO
PARTICIPATE IN RESEARCH IS A
BIGGER HURDLE TO JUMP OVER.
IT IS A LINKAGE BECAUSE WE'VE
BEEN TALKING ABOUT EXISTING
MEDICATIONS.
I'M ALSO HERE TO MAKE SURE WE
STAY FOCUSSED ON THE DEVELOPMENT
OF NEW DRUGS AND WHAT IT'S GOING
TO TAKE TO GET THE RESEARCH FOR
THAT.
>> THANK YOU.
I THINK IT'S AN IMPORTANT PIECE
AND CLEAR COMPONENT OF 6A AND
REMINDED ME OF A POINT IN
SESSION 1 ABOUT THE COALITION
AND BRINGING TOGETHER OTHER
EXPERT COMMUNITIES.
I THINK IT'S A CRITICAL PIECE.
SO UNDERSTANDING THE CAST OF THE
MESSAGING WITHIN THE COMMUNITY
GOES BEYOND OBSTETRICS AND
GYNECOLOGY BUT TO THE ENTIRE SET
OF COMMUNITIES WHERE THERE'S
THERAPEUTICS DEVELOPMENTS GOING
ON.
HOW DO WE ENSURE THERE IS THAT
INFUSION OF INFORMATION TO
INFORM THEM ABOUT WHY THE
RESEARCH IS NECESSARY AND WHY
THEY'RE UNDERSTANDING OF THE
INFORMATION AND HOW IT INFORMS
THE ACTUAL RISK VERSUS BENEFIT
IS ALSO IMPORTANT.
LYNN.
>> PIGGYBACKING OFF THAT I'M
THINKING WHEN THE WORD EVIDENCE
BASE IN 6.
I WANT TO PROPOSE I THINK A GAP
IN RESEARCH RIGHT NOW IS FUNDING
FOR PARTNERSHIPS WITH EXPERTS IN
FOR EXAMPLE SCHOOLS OF
COMMUNICATION AND JOURNALISM WHO
ARE THE ONES WHO DEVELOP THE
RESEARCH FOR EVIDENCE BASED
COMMUNICATION STRATEGIES AND I
THINK IN HEALTH CARE MEDICAL
FIELD, WE NEED TO PARTNER WITH
THE EXPERTS WHO DEVELOP AND TEST
COMMUNICATION STRATEGIES AND
DETERMINE HOW THEY NEED TO
EVOLVE WITH DIFFERENT
COMMUNITIES AND GENERATIONS AND
LITERACY LEVELS AND SUCH AND I
WOULD LOVE TO SEE MORE FUNDING
SPECIFICALLY FOR THOSE KINDS OF
PARTNERSHIPS.
>> I KNOW SOMEONE ELSE HAD A
COMMENT ABOUT THE SAME TIME BUT
MISSED WHO IT WAS.
>> IT WAS ME BUT I THINK DR. YE
STOLE MY SHOW.
I WAS THINKING THE SAME THING.
ACTUALLY TO CONTINUE THAT IDEA I
WAS ALSO CURIOUS ABOUT AN
ASSUMPTION IN RECOMMENDATION 6
THREES AN EXISTING WORKFORCE TO
DO THE COMMUNICATION WORK BUT I
FEEL EMBEDDED IN RECOMMENDATION
5 AS WE THINK OF THE ONGOING
TRAINING OPPORTUNITIES ARE WE
ALSO THEN PROVIDING TRAINING AND
ENGAGEMENT IN PEOPLE WHO DO
COMMUNICATION OR ASKING TO THINK
ABOUT DISSEMINATION AND WHEN WE
THINK OF THE INVOLVEMENT IN
FAMILY PARTNERS NOT AS
REQUIREMENT FOR CONSENT BUT
COMFORT, ENGAGEMENT, INTEREST
AROUND RESEARCH OR TAKING NOVEL
THERAPEUTICS LYNN WAS TALKING
ABOUT HAVE A BEHAVIORAL SCIENCE
FOCUS AND CONSIDERING THE
WORKFORCE IS AN INTERESTING
ENGAGEMENT IS VALUABLE TO AVOID
BACKLASH WE'VE SEEN AROUND NOVEL
THINGS LIKE COVID OR RSV VACCINE
IF WE START THAT CONVERSATION
FROM THE BEGINNING WITH
BEHAVIORAL SCIENTIST COLLEAGUES
CAN WE DO MORE FROM THE
BEGINNING.
THANKS FOR DR. YEE FOR STARTING
THAT.
>> VERY GOOD.
OTHER COMMENTS ONLINE I'VE
MISSED?
SEEING NONE --
>> NOT TO PUT FDA ON THE SPOT
BUT THE THOUGHT OCCURRED TO ME
THAT THERE MAY BE AN TONIGHT
WHEN WE THINK ABOUT THE PATIENT
FOCUSSED DRUG DEVELOPMENT THAT
MAYBE THERE'S SOMETHING THERE
AND I'M GOING THROUGH THE LIST.
I KNOW THOSE MEETINGS ARE
SPECIFIC TO PARTICULAR
CONDITIONS BUT I DON'T KNOW IF
THERE'S BEEN A THOUGHT OR IF
THERE'S A NEED TO CONSIDER
PREGNANCY OR CONDITIONS SPECIFIC
TO PREGNANCY THAT START THAT
CONVERSATION GOING.
GOING SOME FDA-LED PATIENT FOCUS
THERE NEEDS TO BE SUPPORT.
>> WE DO HAVE WORKSHOPS ON
PRETERM BIRTH AND WE ALWAYS HAVE
A PATIENT COMPONENT IN ALL THE
WORKSHOPS WE DO.
MAYBE I'M NOT UNDERSTANDING
EXACTLY.
>> I'M THINKING LIKE A FULL
PFDD-FDA LED MEETING ON LIKE
PREGNANCY.
SOME CONDITIONS TO GET TO THE
CONSUMER SIDE AND WHAT THEY
VALUE AND THINKING OF THE TYPES
OF INFORMATION AND MAYBE IT'S
SOMEWHERE AND MAY JUST NEED TO
BE PULLED TOGETHER SO OTHER
FOLKS CAN HELP DISSEMINATE.
THE THOUGHT OCCURRED THAT'S
SOMETHING I WASN'T AWARE OF
HAVING HAPPENED BEFORE.
>> THERE'S BEEN A LOT OF
DIFFERENT WORKSHOPS.
WE DID ONE ON REAL WORLD
EVIDENCE USING THAT IN PREGNANCY
AND LACTATION.
THERE'S RESOURCES THAT COULD BE
DISSEMINATED.
I'M TRYING TO GET TO THE
COMMUNICATION PIECE AND LEILA
YOU DEAL WITH THE LABEL WITH
INFORMATION AND BEYOND THE
LABEL, WE DON'T PUT OUT LIKE --
THAT'S OUR COMMUNICATION PIECE
ABOUT THE MEDICATION.
>> DO YOU WANT TO ADD ANYTHING
OR NO?
>> AT THE RECENT PRETERM BIRTH
PUBLIC WORKSHOP THERE WERE
SESSIONS THAT INCLUDED PATIENTS.
WE SPECIFICALLY ASKED THEM WHAT
ARE YOU INTERESTED IN IN SEEING
IN TERMS OF DEVELOPMENT OF
PRETERM PRODUCTS TO PREVENT
REOCCURRENCE OF PRETERM BIRTH
AND IN TERMS OF WHAT IS
IMPORTANT TO YOU RELATED TO YOU
HAVING HAD PREVIOUS PRETERM
BIRTH AND HAVING A PRETERM BABY
AND WHAT DR. ARE THE OUTCOMES
YOU'RE INTERESTED IN BECAUSE FDA
IS INTERESTED IN HEARING FROM
YOU AS A PATIENT AND HAVING
EXPERIENCED THAT IN THE PAST SO
WE DEFINITELY DO TAKE THE
PATIENT VOICE AND WHAT THE
PATIENT IS INTERESTED IN INTO
CONSIDERATION.
>> AND JUST TO ADD ONE OTHER
THING, WE RECENTLY HAD A
REGULATORY SERIES OR OFFICE PUT
OUT AND WE WORKED WITH LEILA AS
YOU GROUP ON THIS AND HAD TWO
WEBINARS, ONE WAS FOR NHLING
PROVIDERS ON OPPORTUNITIES
ENGAGING IN RESEARCH ON
PREGNANCY AND LACTATION AND WE
HAVE THE PROGRAMMING WE PUT OUT
THERE.
>> THANKS FOR THOSE PIECES.
PAMELA I THINK YOU HAD A
QUESTION ONLINE.
>>>> THANKS FOR THOSE PIECES.
PAMELA I THINK YOU HAD A
QUESTION ONLINE.
>>THERE.
>> THANKS FOR THOSE PIECES.
PAMELA I THINK YOU HAD A
QUESTION ONLINE.
>>
>> THERE'S DRUG THERAPIES FOR
LACTATION SUCH AS MASTITIS AND
MILK SUPPLY CONCERNS.
I THINK THAT IS OFTEN
OVERLOOKED.
I WANTED TO BRING THAT UP.
THANK YOU.
>> IT'S ALWAYS IMPORTANT IT
REEMPHASIZE AND NOT FORGOTTEN
ABOUT THE CRITICAL NATURE.
I THINK WITH THE LAST 10 MINUTES
ONE AREA WE SHOULD CONTINUE TO
FOCUS ON A LITTLE BIT HERE TO
UNDERSTAND THE STATUS OF OUR 6C
AND 6D IN ENGAGING WITH HEALTH
CARE PROVIDERS TO DISCUSS
PARTICIPATION IN RESEARCH, WHY
RESEARCH IS IMPORTANT TO THE
CARE OF PATIENTS WHO ARE
LACTATING AND THEY'RE
INVOLVEMENT AND WHY █THE DATA
GENERATION IS IMPORTANT.
HOW DO WE FEEL WE'VE BEEN ABLE
TO ADDRESS THAT GAP?
>> I HAVE A COMMENT ON THE IDEA
OF HEALTH CARE PROVIDERS WHO
AREN'T CONDUCTING AND ENGAGEMENT
IN CLINICAL TRIALS.
AND ONE CHALLENGE WITH REGARD TO
TRAINING IS COMPENSATION PLANS.
WHEN CLINICIANS ARE REWARDED FOR
HIGH VOLUME PATIENT CARE, EVEN
IF THEY'RE ACADEMICALLY VERY
INTERESTED AND ENGAGING IN
CLINICAL TRIALS OR REGISTRIES BY
ENROLLING PATIENTS OR CONNECTING
TO P.I.s THERE'S LITTLE REWARD
FOR THAT AND IT'S NOT SOMETHING
WE CAN ADDRESS IN THIS CONTEXT
BUT A STRUCTURAL PROBLEM IN
HEALTH CARE WHEN CLINICIANS
REGARDLESS OF PRIVATE PRACTICE
OR ACADEMIC SETTING CAN FIT INTO
THE DAY THE ABILITY TO TALK
ABOUT THESE THINGS WITH
COLLEAGUES ENROLLING PATIENTS IN
TRIALS OR WITH PATIENTS.
THERE'S BIG GAPS THERE.
>> THANK YOU.
THE INCENTIVES PIECE IS ONE OF
THE RECOMMENDATIONS AND I THINK
THAT YOU'RE QUITE RIGHT THAT
PIECE IS CONTINUING TO BE
MISSING.
>> FROM PERSONAL EXPERIENCE
WITHIN AN ACADEMIC INSTITUTION
GETTING RESIDENTS, FELLOWS,
FACULTY TO ENGAGE PATIENTS IN
RESEARCH IS IMPOSSIBLE UNLESS
THEY HAVE AN IMPORTANT ASPECT IN
THE PROJECT AND EVEN THEN THEY
DON'T HAVE THE TIME OR DON'T
THINK ABOUT IT BECAUSE THEY HAVE
SO MANY OTHER THINGS GOING ON
AND OUR ABILITY TO BE IN CLINICS
IS ALSO A PROBLEM.
YOU CAN'T NECESSARILY PASS OUT
INFORMATION OR POST INFORMATION
IN A CLINIC TO ALLOW THEM TO --
OR ALLOW THE PATIENTS TO BE
ENGAGED IN ASKING THOSE
QUESTIONS.
>> I WAS POINTING OUT I WAS
WRONG ON MY TIME.
WE'RE SUPPOSED TO BE ON LUNCH
BREAK ALREADY.
IS THERE ANYBODY ELSE WITH A
PRESSING PIECE THEY'D LIKE IT
ADD AS IT RELATE TO WHERE WE'RE
SEEING CURRENTLY THE
IMPLEMENTATION PLAN FOR
RECOMMENDATION 6.
>> ONE BRIEF SUGGESTION WHICH IS
THAT THERE'S A REGISTRY THE
ANTIRETROVIRAL PREGNANCY
REGISTRY GOING ON MANY AND MY
CLINIC CONTRIBUTES TO IT.
THEY'VE STARTED DOING A PILOT OF
PAYING PEOPLE TO PAYING
CLINICIANS TO UPLOAD DATA INTO
THE APR.
I HAVEN'T TOUCHED BASE WITH
THEIR LEADER YET TO SEE HOW THE
PILOT IS GOING BUT IT WOULD BE
INTERESTING TO HEAR RESULTS IN
THE FUTURE AND SEE IF IT HAS
SUCCESSFULLY RESULTED.
IT'S NOT THAT MUCH BUT PER
PATIENT IT ADDS UP AND IT WOULD
BE INTERESTING TO SEE IF THAT'S
BEEN A SUCCESSFUL WAY TO ENGAGE
CLINICIANS WHO MAY NOT OTHERWISE
BE INCLINED TO UPLOAD DATA.
>> THANK YOU.
TINA.
>> I THINK THEY ALSO WANT
INFORMATION BACK.
THAT'S ANOTHER FORM OF COMPENSATION, SAYING I'VE
PROVIDED THIS TO YOU AND WHAT WILL HELP ME TREAT PATIENTS IN THE FUTURE.
>> THAT FITS IN WITH WHAT IS
STILL NEEDED FOR 6D.
IS THERE A QUESTION?
I SEE THE SCREEN LIT UP?
>> NO, SORRY.
I'LL TRY TO GET IT OFF.
THANKS.
>> I THINK WITH THAT SAID THEN I
THINK THAT WRAPS UP OUR SESSION 2.
THERE'S BEEN INSPIRED, UNFUNDED
WORK THAT'S BEEN DONE,
PASSIONATE MOTIVATED PEOPLE WHO
HAVE TAKEN THE INITIATIVE TO FIX
ENORMOUS GAPS WITH WHAT THEY
HAVE AVAILABLE TO THEM BUT
CLEARLY THERE'S OPPORTUNITY FOR
ADDITIONAL WORK TO BE DONE AND
FUNDAMENTALLY WHAT NEEDS DO THAT
IS FUNDING, FUNDING, FUNDING.
I THINK WE HAVE AT LEFT THE
BACKGROUND WE NEED TO OUTLINE
WHERE WE'RE GOING TO NEED TO
DIRECT OUR REPORT IN REGARDS TO
RECOMMENDATIONS 5 AND 6.
I APPRECIATE ALL OF YOU STICKING
WITH US 10 MINUTES INTO YOUR
LUNCH BREAK AND THINK AT THIS
POINT I CAN HAVE EVERYONE
RELEASED TO THEIR PRE-ORDERED
LUNCHES?
WE'LL RETURN AT WE'RE TOLD WE
CAN TAKE ONE WHOLE HOUR SO WE'LL
HAVE YOU RETURN AT 1:25 EASTERN.
THANKS, EVERYONE.
>> WELCOME BACK TO THE AFTERNOON
SESSION.
SO IN SESSION III, WHAT OUR
COLLEAGUES FROM NICHD AND SUE
AND A WANTED TO MAKE SURE WE DID
WAS GO BACK TO THE
RECOMMENDATIONS WHERE WE'RE
AWAITING ADDITIONAL INPUT OR
WHERE WE WANT TO HAVE A
CONVERSATION WITH YOU ABOUT HOW
BEST TO HANDLE WHAT WE THINK
WILL BE NEEDED WE'LL DRAFT FOR
COUNCIL AND ULTIMATELY CONGRESS.
WE WANTED TO PROVIDE AN
OPPORTUNITY TO DISCUSS WHAT HAD
BEEN A PENDING UPDATE THAT IS
NOW AN UPDATE FROM OHRP AND CAN
WALK YOU THROUGH WHAT THE
RECOMMENDATIONS ARE IN A MOMENT.
WE NOTED FUNDING OR LEGISLATIVE
PROPOSALS AND WANTED TO DISCUSS
WITH YOU WHAT DIRECTION FOR
PURPOSES OF THE REPORT.
TO REMIND YOU WHERE HE WHERE HE
NEEDED INPUT PREGNANT AND LAC --
LACTATING AND CONDUCT OF
RESEARCH FOR PREGNANT AND
LACTATING WOMEN AND
RECOMMENDATION 4A TO ADDRESS THE
REGULATORY BARRIERS FOR RESEARCH
IN WOMEN IN THE MODIFICATION OF
SUB PART B OF THE COMMON RULE
WITH THE TWO SUB COMPONENTS ON
MATERNAL CONCEPT WITHOUT THE
CONSENT OF THE PARTNER AND MINOR
INCREASE OVER MINIMAL RISK AND
RECOMMENDATION 10A IN THE
APPROACHES TO FACILITY PREGNANT
WOMEN AND LACTATING WOMEN IN
CLINICAL FOR THE JUSTIFICATION
OF EXCLUSION AND STUDY STUDY
DESIGN.
ALL OF YOU SHOULD HAVE RECEIVED
IN YOUR INBOX THE THREE-PAGE
SUMMARY OF OHRP AND PROVIDE
PERSPECTIVE ON WHAT YOU SAW IN
THE REPORT AND WHAT WE HEARD IS
THEY'RE AWARE THE
RECOMMENDATIONS ARE THERE AND
THERE'S NOT BEEN FORWARD
PROGRESS IN ENSURING THE PIECE
PROVIDED BUT THERE'S WORK BEHIND
THE SCENES TO TRY TO ADDRESS
THESE AND WANT TO IT UP TO
MEMBERS TO TO SEE IF YOU HAD
PIECES OR REFLECTIONS HOW TO
MAKE RECOMMENDATIONS TO MAKE
SURE THE PIECES MOVE FORWARD OR
NEED TO SUBJECTLY ADAPT
RECOMMENDATIONS TO HAVE THE
PIECES MOVE FORWARD.
HAPPY TO OPEN UP THE MICROPHONE
AND SEE SOME FACES THAT LOOK
LIKE THEY WANT TO MAKE COMMENTS.
KATHERINE.
>> I DON'T KNOW IT CHANGES MY
RECOMMENDATIONS WE SHOULD BE
MAKING BOUGHT IT CONFIRMED IT'S
AN ISSUE BUT I DID NOT GET THE
SENSE THERE WAS A LOT OF WORK
HAPPENING TO ADDRESS WHAT THE
RECOMMENDATION SHOULD SAY.
IN MY OPINION WE SHOULD UPDATE
GITANCE FOR X, Y AND Z AND
THAT'S DISAPPOINTING.
-- GUIDANCE.
>> I WOULD SAY BASED ON WHAT
KATIE JUST SAID IT'S A FOOTNOTE
IN OUR REPORT.
>> KG I BELIEVE WE'RE ABLE TO
INCLUDE THE WRITTEN COMMENT AS
AN APPENDIX AND FEEL IT SHOULD
BE INCLUDED IN THE APPENDIX?
THAT'S A PIECE WE COULD CHOOSE
TO DO.
>> I WAS INTERESTED IN THE PART
OF THE LETTER IF THEY WERE TO
MAKE CHANGES FOR THE REQUIREMENT
FOR CONSENT THAT THEY WOULD HAVE
TO MAKE SURE THERE'S NO PROBLEMS
WITH THAT.
THE CONVERSATIONS HAVEN'T
HAPPENED SINCE 2018 AND IT'S
GOOD TO KNOW THE STATUS OF THAT.
I WONDER THAT IF DEPENDING ON
THE ADMINISTRATION AND WHO
APPROVES CONDITIONS IF THAT
MAKES A DIFFERENCE IN WHICH CASE
TIME MAYBE RAPIDLY RUNNING OUT
IF THERE WERE A CHANGED
ADMINISTRATION BEFORE SUBJECT TO
CONGRESSIONAL APPROVAL.
>> THEY MAKE A MENTION WARE NOT
SURE WE CAN DO THIS SO MAYBE
WITH THE OFFICE OF THE SECRETARY
OF HHS AND ARE WE SENDING THE
RECOMMENDATIONS TO THE WRONG
PLACE BECAUSE THEY'RE BASICALLY
PASSING THE BUCK UP.
SHOULD WE RECOMMEND IT NEEDS TO
GO HIGHER IN HHS TO HAVE THE
CHANGES MADE?
>> IT'S AN IMPORTANT QUESTION ON
THE TABLE.
THOUGHTS?
>> YES.
>> RACHEL.
I THINK THE HIERARCHY THE HIGHER
LIKELIHOOD YOU'RE ENCOUNTERING
POLITICAL POIAPPOINTEES VERSUS
CAREER STAFF AND THEY'LL PAY THE
ATTENTION IT DESERVES BUT HAS
THE POTENTIAL TO BE CHALLENGING.
WHEN UPDATES HAPPENED PREVIOUSLY
TO THE COMMON RULE IT WAS UNDER
THE RADAR A LITTLE BIT AND THAT
WAS REALLY IMPORTANT AT THE TIME
TO HAVE THEM GO THROUGH.
THAT'S WHAT I RECALL.
YES, I AGREE.
I IMAGINE ENTHUSIASM AND SUPPORT
FOR THIS AND CONCERNED WHAT THIS
LOOKS LIKE UNDER A DIFFERENT
ADMINISTRATION.
>> OTHER THOUGHTS?
I DON'T WANT TO IGNOR FOLKS
ONLINE IF YOU HAVE COMMENTS OR
THOUGHTS.
BECKY.
>> BECKY WITH SMFM.
WE SHOULD BE CAREFUL IN HOW WE
PROCEED.
I THINK THERE'S THINGS WE CAN DO
AND NOTICE OF RULE MAKE PROCESS
AND EVEN IF THEY'RE NOT CHANGING
REGULATIONS I THINK IF WE CAN
PUSH THEM TO AT LEAST PUSH THEIR
PART TO EDUCATE IRBs WHAT THE
CURRENT REGULATIONS ARE AND
THERE ARE THINGS WE CAN DO
WITHOUT OPENING UP THE
REGULATIONS.
SO AS WE'RE THINK ABOUT OUR
REPORT MAYBE THAT'S THE WAY TO
THREAD THE NEEDLE GIVEN THE
UNCERTAINTY WITH THE
REGULATIONS.
>> YOU THINK MORE SO TO
REGULATION 10 HOW THEY CAN FOCUS
HOW TO GUIDE -- IT'S MORE
GUIDANCE OPPOSED TO RULE MAKING
SO MAINE MAYBE FOCUS OUR
ATTENTION ON THE GUIDANCE PIECE?
>> THAT'S SOMETHING I MIGHT
RECOMMEND IF OTHERS AGREE.
WHAT'S IN 1 IS SUPER IMPORTANT
BUT AGAIN WE PROBABLY SHOULD
HAVE STARTED IT TWO YEARS AGO.
>> THOUGH I SAID TO GO UP TO THE
SECRETARY I AGREE IT'S REALLY
NOT THE TIME AND I THINK THESE
ARE REALLY UNSATISFYING AND THE
GUIDANCE THEY POINT TO IS THE
LETTER FROM SACHRP WHICH IS VERY
BROAD.
IT'S NOT AT ALL -- IT MENTIONS
PREGNANT WOMEN AS ONE CATEGORIES
OF JUSTICE BUT IT'S NOT HELP FOR
IN WHAT WE'RE LOOKING FOR SO I
THINK GUIDANCE BECAUSE IT'S
SOMETHING OHRP CAN DO AND FOCUS
AND SAY WE APPRECIATE THE
SECRETARY'S ADVISORY COMMITTEE
HAS DONE THIS LETTER ON JUSTICE
GENERALLY BUT IT DOESN'T GO FAR
ENOUGH FOR THE PURPOSES WE'RE
TALKING ABOUT.
>> I'D LIKE TO ADD ONE ITEM AND
I REALIZE IT'S A LITTLE BIT TO
THE NIH INCLUSION POLICIES.
I'M FROM PEDIATRICS.
IN 1998 IS WHEN THE NIH FIRST
MANDATED GRANTS IN HUMAN SUBJECT
RESEARCH INCLUDING CLINICAL
TRIAL CAN COME IN WITH A SECTION
ADDRESSING PEDIATRIC INCLUSION
WHICH IS ANYBODY UNDER 21.
PEOPLE CAME IN WITH CHILDREN AT
THE AGE OF 19 AND 20 WHO COULD
CONSENT AND THAT SATISFIED THAT.
I THINK MAYBE SIX OR SEVEN YEARS
LATER THE NIH REVISED THE AGE
RANGE FOR WHAT THEY CONSIDERED
CHILDREN TO BE UNDER 18.
THAT AGE GROUP HAD TO BE
ADDRESSED IN NIH GRANT
APPLICATIONS INCLUDING A SECTION
DESCRIBING PEDIATRIC INCLUSION
OF CHILDREN AND THAT'S ADDRESSED
BY REVIEWERS AND GRANTS GET
CODED WHETHER THE INCLUSION IS
JUSTIFIED.
THERE'S BEEN A SERIES OF
WORKSHOPS IN THE LAST 10 YEARS
THAT ADDRESS INCLUSION ACROSS
THE LIFE SPAN.
RELATING TO PEDIATRICS I THINK
IN 2017, POLICY CHANGES THAT NOT
ONLY DO YOU HAVE TO ADDRESS
INCLUSION OF PEDIATRICS BUT NOW
THE AGE OF ALL PARTICIPANTS FROM
MINUTES TO YEARS NEEDS TO BE
FORD EACH PARTICIPANT IN AN NIH
CLINICAL TRIAL AND EFFECTIVE
2019 AND THAT DATA IS AVAILABLE
ON THE INCLUSION GOVERNANCE
WEBSITE FOR THE NIH.
AND INCLUDES ELDERS AS WELL
WHICH IS AN UNDER REPRESENTED
POPULATION.
THE NEW LANGUAGE AND
CLARIFICATION AROUND PEDIATRIC
INCLUSION, LIFE SPAN INCLUSION
INCLUDES ADDRESSING YOUR
DISTRIBUTION OF AGE WITHIN THE
CLINICAL TRIAL AND IS THAT
JUSTIFIED OR NOT.
RIGHT NOW NOTHING ADDRESSES THE
INCLUSION OF PREGNANT
INDIVIDUALS OR THE INCLUSION OF
LACTATING INDIVIDUALS IN
CLINICAL TRIALS.
I COULDN'T EVEN TELL YOU HOW THE
NIH ENTERPRISE IS DOING WITH
INCLUSION OF THOSE POPULATIONS.
AS WE TALK ABOUT CHANGING THE
LANGUAGE TO ENHANCE INCLUSION,
WE DON'T REALLY HAVE A GREAT WAY
TO TRACK THAT AT THE MOMENT.
WE ARE TAKING SOME APPROACHES
AND WORKING WITH THE NIH'S
OFFICE OF PORTFOLIO ANALYSIS TO
SEE WHAT AWAY CAN PULL OUT BUT
THAT'S INVOLVING SEARCH TERMS,
ETCETERA, THERE'S NO TRACKING
WHEREAS IF YOU ASK ME HOW MANY
4-MONTH-OLDS ARE RECRUITED IN
NIH TRIALS WE CAN PULL THAT
DATA.
I WANT TO POINT OUT THAT'S
CURRENTLY A GAP THAT THIS GROUP
MAY WANT TO CONSIDER AS IT
THINKS IF WE TAKE EFFORTS TO
IMPROVE INCLUSION OF PREGNANT
AND LACTATING PEOPLE IT'S
IMPORTANT TO TRACK PREGNANCY AND
LACTATION SEPARATELY FOR ALL THE
EFFORTS WE COUNTERLY DON'T HAVE
A GOOD WAY TO TRACK -- CURRENTLY
DON'T HAVE A GOOD WAY TO TRACK.
>> THANK YOU, AARON.
ANY MORE?
>> I WOULD ADD THIS TO THE
ABILITY TO TRACK TO ULTIMATELY
UNDERSTAND HOW WE'RE PROGRESSING
ON THIS AT THE NIH LEVEL IN
ADDITION TO THE GUISES WITHIN
HHS AND OTHER THING IN RESPONSE
TO THE LAST CONVERSATION WHICH I
AGREE WITH A PLUG FOR THE TIME
IS NOW AND THOUGH IT SEEMS
THERE'S EASY THINGS TO DO
THERE'S NUANCES AND IF WE DON'T
PUSH NOW TO HAVE IT DONE WE'RE
GOING TO LOSE THE OPPORTUNITY.
AND I SUGGEST AT THE VERY LEAST
WE DIRECT IT AT THE OFFICE OF
THE ASSISTANT SECRETARY TO BUMP
IT UP A LEVEL AND PROVIDE THAT
RECOMMENDATION.
>> SHARON.
>> WOULD IT HELP TO HAVE A
SNAPSHOT OF PREGNANCY OR
LACTATING INDIVIDUALS IN STUDIES
IN THE LAST FEW YEARS, WE HAVE A
NETWORK MUCH ARE REPRESENTATION.
WE ALL KNOW WITHIN OUR NETWORKS
HOW MANY PREGNANT AND LACTATING
INDIVIDUAL WE ENROLL IN THE LAST
FEW YEARS AND OF THE THREE OR
FOUR FOLLOWING NETWORKS, THIS
MANY PEOPLE ENROLLED TO GIVE NOT
A GREAT SNAP SHOT BUT A SCOPE OF
WE'RE NOT TALKING FIVE BUT
HUNDREDS AND THOUSANDS SO THE
WEIGHT OF WHY WE WANT TO KICK IT
UP A NOTCH IS THERE'S HUGE
PARTICIPANTS IN THE STUDY AND
YOU CAN GIVE RAW NUMBERS.
I KNOW FROM MY NETWORK HOW MANY
PREGNANT, LACTATING INDIVIDUALS
I ENROLLED IN THE LAST FEW
YEARS.
I CAN FIND IN ONE OR TWO
MINUTES.
I SUSPECT THE OTHER NETWORKS
AROUND THE TABLE CAN DO THE SAME
THING.
AT LEAST IT WILL GIVE A SPOKE OF
A NUMBER OPPOSED TO WE DON'T
HAVE IT.
>> IF WHAT I HERE FROM THE WORK
GROUP IS THERE'S CLEAR AGREEMENT
WE HAVE NOT MADE PROGRESS IN
THESE PIECES AND WE NEED TO
STRENGTHEN OUR CALL FOR
ATTENTION TO BE PAID TO THE
RECOMMENDATIONS PERHAPS AN
ESCALATION UNDERSTANDING THE
TIME THAT'S PASSED AND THERE'S
OPTIONS AS IT RELATES TO
GUIDANCE WITH HOW WE GATHER
INFORMATION ON RESEARCH TAKING
PLACE IN PREGNANT AND LACTATING
POPULATIONS TO BEGIN TO QUANTIFY
FOR DECISION MAKES WHAT THE
NEEDS ARE TO CONTINUE IN THIS
SPACE.
IS THAT WHAT I'M HEARING FROM
THE WORK GROUP?
IS THAT WHERE THE FOCUS SHOULD
BE?
WE'LL CAPTURE AND THAT IF YOU
FEEL WE HAVE NOT ADDRESSED IT TO
YOUR LIKING, PLEASE LET US KNOW.
>> I THINK WE CAN RECOGNIZE AND
I THINK PART OF THE CONCERNS IS
RULE MAKING IS A LONG INVOLVED
TORTUROUS PROCESS BUT IN THE
MEANTIME GUIDANCE COULD BE
QUICKER.
WE COULD ACKNOWLEDGE TWO PIECES
AND WE RECOGNIZE ONE IS A LONG
AND INVOLVED PROCESS AND
POSSIBLY ISN'T FEASIBLE BUT IT
DOESN'T MEAN NOTHING CAN HAPPEN
WITH TE GUIDANCE PIECE.
>> TO YOUR POINT IS GUIDANCE CAN
BE HELPFUL TO GET EXPERIENTIAL
POLICIES AND BETTER RULES.
VERY GOOD.
GOOD RECOMMENDATION.
WE'LL CONSIDER THEN THIS PIECE
ON THE REPORT FROM OHRH CLOSED
FOR PURPOSES OF DISCUSSION
TODAY.
SO THEN LET'S MOVE ON TO THE
PIECE WE WANTED TO TALK ABOUT
WHICH IS HOW TO ENSURE WE
PROPERLY CAPTURE WHAT WE'D LIKE
IT SEE AS IT RELATES TO
CONGRESSIONAL ACTION OR 8A AND
9B.
TO REMIND YOU, IF YOU CAN GO TO
THE NEXT SLIDE PLEASE.
FOR RECOMMENDATION 8 THERE WAS A
PRODUCTS IN PREGNANT AND
LACTATING WOMEN AND ONE OF THE
CALLS WAS TO PROVIDE SPECIFIC
FUNDING.
THAT ONE'S PRETTY EASY.
WE NEED CONGRESSIONAL ACTION TO
PROVIDE SPECIFIC FUNDING.
IF WE CAN GO TO RECOMMENDATION 9
ON THE NEXT SLIDE YOU'LL RECALL
A RECOMMENDATION TO CONSIDER
PROGRAMS THAT ARE IN PLACE IS TO
HELP DRIVE DISCOVERY AND
PRODUCTS FOR PREGNANT AND
LACTATING WOMEN AND THERE WAS A
SPECIFIC REFERENCE TO
CONSIDERATION OF A BARDA LIKE
MODEL IN THE AND THE NIH MODEL
THAT TAKES DEVELOPMENT UP TO
THESE THREE.
THESE ARE THE TWO PIECES WE
WANTED TO GET YOUR INPUT ON AND
HOW YOU WOULD LIKE FOR US TO
HANDLE THEM IN THE DRAFT OF THE
REPORT TO COUNCIL AND CONGRESS
TO ENSURE WE'RE PUTTING FORWARD
THE PROPER CALL FOR THEIR
ACTION.
>> WE NEED MORE FUNDING.
>> THAT'S GOING TO BE A
FUNDAMENTAL THEME IN THE
DOCUMENT BUT SPECIFIC TO -- IS
THERE A CALL FROM THIS WORK
GROUP THEN FOR A PROGRAM TO
DEVELOP -- BE DEVELOPED TO MODEL
THIS PROGRAM THAT IS ADEQUATELY
FUNDED AND IS FUNDED FOR --
>> THAT WOULD BE MY
RECOMMENDATION IS TO HAVE A
SPECIFIC CALL OUT FOR THAT.
>> I AGREE AND WE'VE HAD SUCCESS
WITH EFFORTS ON THAT PART.
I DON'T KNOW IF ACOG OR OTHER
GROUPS WOULD WANT TO TAKE THAT
ON BUT ONE OF THE AAP DOESN'T
LIKE LOBBYING AROUND THE APPCA.
>> THE SHORT ANSWER IS, YES.
AND ACTUALLY IT WAS AND I'M
LOOKING AT KATIE BECAUSE I
REMEMBER OUR FIRST CONVENING
BEFORE OUR COALITION HAD A NAME
OF THE MATERNAL THERAPEUTICS
THIS IS WHAT WE TALKED ABOUT AT
OUR FIRST MEETING OVER A DECADE
AGO NOW.
ALL THE WORK DONE AND
CONVERSATIONS ENABLED US TO GET
TO THIS PLACE WHERE WE FEEL WITH
MORE AUTHORITY WE CAN SPEAK TO
AND WAVE DONE THE GROUND WORK TO
SPUR THIS.
AT THE TIME THE CHALLENGE WAS
YES, WE'VE SEEN IT'S SUCCESSFUL
BUT WE NEEDED AND WANTED THE
CONVERSATION TO HAPPEN FIRST TO
FEEL LIKE WE HAD MORE BEHIND US.
AND A ROUNDABOUT WAY OF SAYING
WE'RE INTERESTED IN ADVOCATING
FOR THIS AND IT TOOK THE
PEDIATRIC COMMUNITY A LONG TIME
TO GET THIS DONE.
I'M NOT ANTICIPATING IT WILL BE
A QUICK WIN BUT I THINK IT
SHOULD BE CLEARLY RECOMMENDED.
CLEAR AND SPECIFIC ADDED TO THE
REQUIREMENTS AND IT NEEDS TO BE
SPECIFIC AND LACTATION.
IT NEEDS SPECIFIC FUNDING FOR
THAT BECAUSE THAT'S WHERE WE
DON'T WANT -- WE DO NOT WANT
THERE TO BE COMPETING INTEREST.
THERE'S NOT ENOUGH TO GO AROUND.
>> IT SHOULD BE ITS OWN THING
AUTHORIZED RESEARCH
PRIORITIZATION FUND AND WE
SHOULD CALL ON CONGRESS TO TAKE
ACTION ON IT.
>> CRAFTING THE RECOMMENDATION
TO ENSURE IT DOESN'T JUST FALL
ON NICHD BUT FUNDING ACROSS
INSTITUTES THAT ARE IMPACTED OR
DO RESEARCH IN PREGNANT AND
LACTATING PEOPLE AND NICHD
SHOULD BE THE PIGGY BANK FOR
THAT.
>> I THINK BEFORE I GO TO THE
NEXT ITEM I THINK THAT'S A GOOD
COMMENT BECAUSE WE HEARD IN THE
LAST MEETING THE WORK THAT'S
ALREADY DONE TO PRIORITIZE WHERE
THERE'S NEED AND WE CAN LEVERAGE
THE WORK YOU HAVE NICELY
PRESENTED CAMILLE AND AARON FOR
PURPOSES OF MAKING THAT POINT
RESONATE.
>> I DON'T THINK I'VE MISSED
ANYONE SO I THINK WE'VE GOT THE
GOOD CONTEXT FOR WILL 8 ON
CONGRESSIONAL ACTION AND LET'S
TRANSITION TO 9.
THOUGHTS?
IN CONSIDERING THE PIPELINE THE
CONVERSATION FOR FUNDING NEEDS
TO BE BASIC AND TRANSLATIONAL
AND THINGS IN THE CLINICAL SPACE
LIKE IN VITRO TOOLS AND
COMPUTATIONAL TOOLS AND
UNDERSTANDING OF BASIC
METABOLISM TO UNDERSTAND
TRANSFER OF PHARMACEUTICALS
ACROSS THE PLACENTA OR THROUGH
THE MAMMARY GLAND INTO THE
BREAST MILK.
THERE'S A LOT OF DEVELOPMENT
THAT COULD HAPPEN AND INTEREST
FROM EPA FOR MODELS AND THERE'S
A LOT OF GAPS AND I JUST WANT TO
PUT IN THE PLUG BECAUSE THE MORE
WE KCAN TEST THE CHEMICALS THE
MORE WE CAN RELEASE THEM IN MORE
CLINICAL TRIALS.
>> THANK YOU, ALISON.
COMMENTS FROM OTHERS?
>> I AGREE.
I THINK THAT'S A HUGE
OPPORTUNITY TO PUSH THAT BACK TO
THE PHARMA INDUSTRY TO DEVELOP
THOSE ASSAYS AND GENERATE THE
DATA THAT COULD FILL IN GAPS
EVEN PRIOR TO GETTING DRUG
APPROVAL BECAUSE UNFORTUNATELY
WHAT WE'RE TALKING ABOUT TODAY
IS POST APPROVAL STUDIES.
THAT COMES MANY MANY YEARS AFTER
A DRUG'S APPROVED AND BEING
USED.
SO I KNOW AT ONE POINT IN TIME
WE TALKED ABOUT SOME TYPE OF
INCENTIVE PROGRAM FOR ANYBODY
BUT AS IT WOULD MAYBE APPLY TO
PHARMA LIKE WHAT WE DID FOR THE
JUVENILE SPACE.
YOU PUT UP AN INCENTIVE, PHARMA
IS GOING TO COME AND FILL IN THE
DATA GAPS CURRENTLY UNAVAILABLE.
>> THINK YOU'RE TALKING ABOUT
THE INCENTIVE PROGRAM NOT THE
DDCA.
>> NO, JUST BACK WHEN JUVENILE
TOX WAS NOT MAINSTREAM.
WHEN THE INCENTIVE CAME FOR
PHARMA TO DO THAT AND NOW DOING
JUVENILE TOX FOR MOST OF OUR
PROGRAMS AND I THINK THERE'S AN
INCENTIVE FOR GENERATING THE
DATA FOR PREGNANT AND LACTATING
WOMEN THAT PROBABLY THE BIG
PHARMA WOULD STEP UP AND START
TO DO THAT WORK AND DONE PRIOR
TO DRUG APPROVALS.
>> LET ME ASK A QUESTION AND
TONY THIS ISN'T DIRECTED TO YOU
BUT THE GROUP.
THE LANGUAGE OF THE
RECOMMENDATION THE SUB PART WAS
CONSIDER.
DO WE WANT TO SEEK TO REVISE
THAT WITH STRONGER LANGUAGE SUCH
AS "CREATE" INSTEAD OF
"CONSIDER"?
>> LET'S DO IT.
TO RACHEL'S POINT THE
CONVERSATION TO THIS POINT HAS
BEEN CAREFUL INTENTIONALLY
BECAUSE WE WANT TO MAKE SURE THE
RECOMMENDATIONS ARE APPROPRIATE
AND COMPLEMENTARY POT WORK --
TO THE WORK BEING DONE AND TO
LOOKING BACK TO WHAT GOT THIS
GROUP TO IS THIS POINT AND
OTHERS THE STRONGEST LANGUAGE WE
CAN USE IS WILL BE THE MOST
USEFUL FOR EVERYONE AND GET US
THE FURTHEST IN TERMS OF CLOSING
THE DATA GAP.
>> OTHERS?
LOOKS LIKE THERE WAS A LOT OF
HEAD NODDING IN AGREEMENT SO
I'LL TAKE THAT AS AGREEMENT.
THE OTHER PIECE I'LL THROW OUT
THERE TOO IS SHOULD WE ALSO
BUILD IN A SUB PART SPECIFICALLY
CALLING OUT HOW TO FACILITATE
ALL THESE NON-CLINICAL PIECES
WHICH YOU'RE RIGHT ARE ESSENTIAL
TO GET TO TRANSLATION.
>> RIGHT NOW IT'S LUMPED INTO
ONE SENTENCE BUT SPECIFIC
LANGUAGE AROUND THE EARLY
NON-CLINICAL COULD BE GOING ON
WITH CLINICAL TRIALS BUT SOME OF
THAT BASIC RESEARCH COMPONENT
NEEDS TO BE BROUGHT FORWARD I
THINK.
>> OTHER COMMENTS.
OTHER THOUGHTS?
I DON'T SEE HANDS ONLINE AND
VERY GOOD.
THANK YOU SO MUCH FOR HELPING
THE CONTEXT FOR WHAT WILL BE THE
REPORT AND MODIFICATIONS TO EVEN
STRENGTHEN SOME OF THE
RECOMMENDATIONS THERE TO SEE
THEM MOVE TO FRUITION.
WE ARE AHEAD OF SCHEDULE AND WE
HAVE A BREAK COMING UP.
HOW DOES NICHD WANT TO PROCEED?
SO, WE'RE GOING TO MOVE A REVIEW
TO MAKE SURE WE DON'T HAVE ANY
OPEN ITEMS FROM THIS MORNING'S
DISCUSSION AND TRANSITION THINGS
TO YOU FOR THAT ACTION.
>> SO, THIS MORNING WE DISCUSSED
RECOMMENDATIONS 3, 5 AND 6.
I FEEL THE CONVERSATION WAS
REASONABLY COMPREHENSIVE BUT ARE
THERE ANY ADDITIONAL THOUGHTS,
COMMENTS THAT HAVE NOT BEEN
VOICED YOU THOUGHT ABOUT DURING
LUNCH AND MAKE SURE WE HAVE
CAPTURED IN THE REPORT?
WE STARTED WITH RECOMMENDATION 3
AND LET ME JUST -- AND THAT HAD
TO DO WITH EXPANDING THE
WORKFORCE OF CLINICIANS AND
RESEARCH INVESTIGATORS WITH
EXPERTISE IN OB -- OBSTETRIC
AND SALARY BASED ISSUES AND
INCREASING OPPORTUNITIES FOR
AWARENESS, INCREASING SUPPORT
FOR MENTORS, CONNECTING MENTORS
AND TRAINEES TO ESTABLISHING
NETWORKING EXPERIENCES OR
OPPORTUNITIES.
EXPANDING EDUCATIONAL
REQUIREMENTS AND WE'VE CAPTURED
A LOT OF THOUGHTS AROUND THAT.
>> I FELT WE SKIPPED A LITTLE
QUICKLY OVER 6AC.
WE DID A AND B AND THINK WE
SKIPPED ON 6B.
I THINK CREATE OPPORTUNITIES
SOUNDS THEORETICAL.
WHETHER THERE ARE CONCRETE IDEAS
ON SPEAKING OUT AND BRINGING IT
BACK TO WE'RE NOT TALKING ABOUT
REACHING OUT TO THE OB-GYNs OR
PEDS INS -- IN THIS AND SEND
THEM BACK.
IF THERE'S ANYTHING CONCRETE FOR
THOSE WHO SPOKE THIS MORNING.
>> ARE YOU SAYING TIE IT TO
CURRICULA?
>> YES, IT DOESN'T MATTER IF
YOU'RE AN ONCOLOGIST ON
DERMATOLOGIST AND DEALING WITH
MEDICATIONS IN SPECIAL
POPULATION US DON'T NORMALLY
THINK OF WHEN YOU THINK OF YOUR
PROFESSION AND YOU ONLY CAPTURE
NEW PROFESSIONALS THAT WAY SO
YOU NEED IT PART OF THE
CONTINUING AS IT SAYS HERE.
>> I'LL ASK YOU TO REFRAME THAT
JUST A LITTLE BIT SINCE WE'RE
NOT TALKING ABOUT MAKING
RECOMMENDATIONS TO THE EXTEND
WE'RE EVALUATING PROGRESS ON
IMPLEMENTATION.
SO AS I THINK ABOUT WHAT YOU'RE
SAYING I HEAR YOU SAYING THERE'S
ADDITIONAL PARTIES THAT NEED TO
BE BROUGHT IN THE CONVERSATION.
>> MAYBE BE MORE SPECIFIC AND
CALL OUT WE NEED TO TALK TO
PSYCHIATRISTS BECAUSE RIGHT NOW
IT BROADLY STATES MEDICAL
NURSING PHARMACISTS AND OTHER
HEALTH CARE PROVIDERS AND MAYBE
BEING MORE SPECIFIC AND CALL OUT
THE BROAD APPROACH IS NEEDED IN
ORDER TO REACH EVERYBODY WHO
SHOULD KNOW ABOUT IT.
>> I'M GOING CHALLENGE THE GROUP
TO THINK ABOUT THIS A LITTLE
BIT.
IF WE'RE SAYING IT HASN'T BEEN
EFFECTIVELY DONE AND WE SHOULD
BE CALLING ON THE PEOPLE, WHO
ARE THE PEOPLE?
WHO ARE WE INDICATING IN THE
REPORT NEEDS TO STEP UP AND TAKE
OWNERSHIP OF THIS PARTICULAR
RECOMMENDATION?
>> PROFESSIONAL ORGANIZATIONS?
>> OKAY.
WHO ELSE?
>> EVERY PROFESSION HASSIS THIS
PROFESSIONAL SOCIETY AND HAVEN'T
CONCEPTUALIZED HOW TO
OPERATIONALIZE THIS PROFESSION
BUT THINK OF EVERY PROFESSIONAL
SOCIETY FOR HAVE RESPONSIBILITY
FOR THERE ARE CONTINUING
CERTIFICATION PROCESSES
INCLUDING IN THE TOPIC.
IF YOU'RE DOING YOUR ANNUAL
MAINTENANCE AND CERTIFICATION AS
AN INTERNIST OR DERMATOLOGIST,
ORTHOPEDISTS, WHATEVER, THEIR
SOCIETY SHOULD REQUIRE X NUMBER
OF HOURS PER YEAR AND
INCORPORATES THESE TOPICS.
I THINK THE PROBLEM -- THE
CHALLENGE IS WHERE IS THE TEETH
IN IT?
WHO MAKES THAT SOCIETY MANDATE
FOR THEIR MEMBERS.
AND I WILL SAY THERE'S A
DIFFERENCE BETWEEN PROFESSIONAL
SOCIETIES AND CERTIFICATIONS.
WE JUST HAVE TO THINK ABOUT THE
COLLABORATIONS THEREIN.
AS IT THE PROFESSIONAL SOCIETIES
THAT HELPFUL FILL THE
REQUIREMENTS FOR THE M.O.C.s.
>> IT'S HARD TO IMAGINE A
SPECIALTY IT WOULDN'T BE
RELEVANT FOR.
MAYBE GERIATRICS.
MAYBE NOT.
>> WE STARTED TO 3 AND JUMPED TO
6 OR ANYTHING IN 5 OR BACK TO 3
THAT MERITS ADDITIONAL COMMENT
THERE THE GROUP?
>> ALISON HURLEY EPA, FOR 5B WAS
IN GAGE -- ENGAGE STAKEHOLDERS
AND PUBLIC AND GLOBAL PARTNERS.
I'M NOT SURE WE TOUCHED ON THE
GLOBAL PARTNERS TODAY.
I KNOW THERE WERE STATEMENTS
MADE ABOUT COLLABORATIONS AROUND
COVID AND ZIKA AND SURE IT
INCLUDES GLOBAL PARTNERSHIPS IN
CERTAIN RESPECTS AND WONDER IF
THOSE ENGAGED IN THE STAKEHOLDER
COMMUNICATION CAN COMMENT ON THE
GLOBAL ASPECTS AND WHETHER YOU
SEE DEFICIENCIES THERE.
>> I THINK WHAT YOU'RE ASKING
ALISON IN TERMS OF DISSEMINATION
OF INFORMATION TO CONSUMERS AND
PROVIDERS, THERE'S MAYBE A
PARTNERSHIP WITH THE EUROPEAN
NETWORK OF INFORMATION SERVICES
THAT DO THE SAME THING AS WHAT
WE DO.
THAT'S A GLOBAL SCALE AND THINK
IT INVOLVES 33 OTHER COUNTRIES
AND THAT'S ONE ASPECT OF IT.
>> I WOULD SAY DURING THE
EXAMPLES, ZIKA AND COVID WE
WORKED WITH W.H.O. AND OTHER
REGIONAL GROUPS OF GLOBAL GROUPS
BUT THERE'S BEEN PARTICULARLY
DURING COVID THE INCONSISTENCY
IN GLOBAL RECOMMENDATIONS AND
CHALLENGES SO THERE'S
OPPORTUNITIES THERE.
>> WE COULD MAKE SURE THE REPORT
CALLED THAT OUT.
SHARON, YOU HAVE SOMETHING TO
CONTRIBUTE.
>> I CAN SAY WHAT WE'VE DONE IN
THE HIV WORLD IS SET UP MEETINGS
WITH GLOBAL PARTNERS.
WE HAVE ROUTINE MEETINGS WITH
W.H.O. AND OUR COLLEAGUES THE
EUROPEAN EQUIVALENT OF WHAT WE
DO ON THE HIV SIDE TO DEVELOP
GUIDELINES ABOUT TESTING AND
ENROLLMENT OF CLINICAL TRIALS
AND SOME ARE AVAILABLE.
WE JUST HAD A MEETING TO DISCUSS
ENROLLMENT OF TB PATIENTS,
PREGNANT AND LACTATING INFANTS,
CHILDREN, ETCETERA AND THOSE
GADE LINES WERE PUBLISHED --
LINES WERE PUBLISHED LAST MONTH.
WE FIND IT MORE HELPFUL TO SET
UP THE MEETINGS, DEVELOP THE
AGENDA AND MEET SO THAT WE KIND
OF KNOW WHAT THE OTHER ONE'S
TALKING ABOUT AND THE GUIDELINES
ARE OUT THERE AND READY WHENEVER
WE HAVE THE NEXT MEDICAL EVENT
OR ZIKA, WHATEVER YOU WANT TO
CALL IT.
IF YOU NEED I CAN SEND YOU TO
THE LINK OF THE GUIDELINES WE
JUST PUBLISHED IN FEBRUARY AND
THOSE ARE NICE START AND TALK
ABOUT THE POPULATION AND HAVE
ALL THE STAKEHOLDERS IN THEM.
I WAN TUT THE LINK IN THE CHAT
IF YOU WOULD LIKE.
>> IT'S A GOOD EXAMPLE, THANK
YOU.
IT WOULD BE FOR PRE-APPROVAL
TYPE RESEARCH AND YOU HAVE THE
ISSUE OF DIFFERENT REGULATORS OF
A DIFFERENT LABEL, DIFFERENT
INFORMATION AND LABELS THAT MAY
COMPLICATE THAT TYPE OF
COMMUNICATION SO THERE WOULD BE
SOME EFFORT THAT WOULD BE PUT
INTO WANTING TO HAVE A
HARMONIZED COMMUNICATION OR
SOMEHOW GETTING THE MESSAGE OUT
THAT WOULD MAKE SENSE IF YOU'RE
LOOKING AT GLOBAL PARTNERSHIPS.
>> ANY THOUGHTS AS THE PUBLIC
AWARENESS CAMPAIGNS, EDUCATION,
DEVELOPING AND IMPLEMENTING
STRATEGY HAVE NOT BEEN CAPTURED?
>> I DON'T KNOW OFFHAND IF ANY
OF THE OTHER RECOMMENDATIONS
CALLED OUT GLOBAL LIKE IT DOES
HERE.
AND WHERE I DO THINK THE GLOBAL
THREAD NEEDS TO BE PULLED IS IN
THE PRIORITIZATION OF SOME OF
THE RESEARCH SPECIFIC TO
PREGNANT AND LACTATING WOMEN
BECAUSE THAT DOES TEND TO BE
WHERE THE GLOBAL MUSCLE AND
BRAIN TRUST CAN HELP MOVE THAT
FORWARD SO IT'S LESS FOR THIS
RECOMMENDATION AND I'M NOT SAVVY
ABOUT WHETHER OR NOT THIS GLOBAL
PIECE IS MENTIONED ELSEWHERE.
>> I MIGHT ASK CAMILLE ON THE
PRIORITIZATION PROFESSION AND
WHETHER YOU'RE GET INPUT FROM
OUTSIDE THE U.S. OR IS MOST
COMING FROM IN THE U.S.?
>> I'D HAVE TO AND MOST ARE
U.S. BASED I WOULD SAY.
I'D HAVE TO DOUBLE CHECK.
I CAN COMMENT IN A FEW MOMENTS.
>> ASSUME THAT'S WHAT YOU'RE
GETTING AT, MEDICATIONS RELEVANT
TO PREGNANT AND LACTATING WOMEN
WHERE THERE'S SPECIFIC
MORBIDITIES.
>> YES AND ONE THING I'M
SPECIFICALLY THINKING ABOUT AND
CAMILLE I CAN FORWARD THE PAPER
IS THE PRIORITIZATION OF NOVEL
DRUG DISCOVERY THAT'S NEEDED AND
SOMETIMES THAT'S OFF PATENT OR
OFF LABEL INDICATIONS AND
SOMETIMES DEVELOPMENT OF NEW
NOVEL DRUG DISCOVERY BUT THAT'S
WHERE THERE'S BEEN SOME GLOBAL
THINKING AROUND MEDICAL
COMPLICATIONS AND WHAT'S NEEDED.
>> I WANTED TO WEIGH IN.
I THINK IT'S GOOD TO GO BACK AND
MAYBE LEVEL SET WHERE THE
RECOMMENDATIONS CAME FROM.
IF I'M RECALLING PROPERLY AND
THERE'S OTHER PRGLAC TASK
MEMBERS IN THE ROOM THIS HAD A
CALL OUT TO GLOBAL BECAUSE THE
INTENTION WITH THE
RECOMMENDATION IS WHY IT'S
IMPORTANT TO DO RESEARCH IN
PREGNANT AND LACTATING
POPULATIONS BUT MORE OF A
GENERAL CALL OUT AND A TOPIC
WHEN YOU THINK ABOUT THIS BEING
A SET OF RECOMMENDATIONS TO THE
U.S. CONGRESS AND WHAT THEY CAN
IMPLEMENT WITHIN THE
U.S. STRUCTURE, THIS CAN EASILY
PARTNER ACROSS OTHER
JURISDICTIONS AND YOU'RE NOT
SEEING THE GLOBAL LANGUAGE IN
THE OTHER RECOMMENDATIONS
BECAUSE MANY CALL FOR SPECIFIC
FUNDING COMING FROM
U.S. SOURCES.
>> THERE ARE EFFORTS ON A GLOBAL
SCALE AND THERE'S AN E-21 WHICH
IS LOOKING AT CREATING SOME
FRAMEWORK AROUND GATHERING
INFORMATION AND THAT PRECLINICAL
SPACE.
THESE THINGS TAKE TIME BUT THERE
ARE EFFORTS GOING ON IN THE
SPACE.
>> IF THERE'S NO OTHER COMMENTS
RELATED TO THIS MORNING'S
SESSIONS WE CAN MOVE ON TO THE
REPORT PREPARATION FOR TAKE A
SMALL BREAK.
WA -- WHY DON'T WE TAKE A
10-MINUTE BREAK AND RECONVENE AT
2:20.
THANKS.
WE'RE GOING TO TRANSITION INTO
PROVIDING MORE DETAIL AND
INFORMATION ABOUT THE FINAL
REPORT AS IT WILL BE DEVELOPED
BY THIS GROUP.
WE HAVE A REPORT DEVELOPMENT
DISCUSSION SLIDE BUT I THINK I
MAY ASK US TO GO TWO SLIDES
FORWARD, PLEASE.
I WANT TO REMIND US WHAT THE
WORKING GROUP IS HERE TO DO.
AS PART OF THE RECOMMENDATIONS
LAID OUT IN PRGLAC WAS
RECOMMENDATION 5 TO ESTABLISH AN
ADVISORY COMMITTEE IN THIS CASE
A WORKING GROUP TO MONITOR AND
REPORT ON IMPLEMENTATION SO
IMPLEMENTATION OF THE
RECOMMENDATIONS AND GUIDANCES
AND REGULATIONS, ETCETERA.
YOU CAN SEE FURTHER IN THE
LANGUAGE WHAT THEY'RE ASKING TO
DO IS ONCE THE CHARTER EXPIRES,
ANOTHER COMMITTEE SHOULD BE
ENGAGED WITH A SIMILAR RANGE OF
EXPERTISE EVERYBODY IN THE ROOM
AND JOINING US ON THE CALL TO
ENSURE THE STEPS RECOMMENDED BY
PRGLAC ARE IMPLEMENTED AND
PROGRESS IS MONITORED.
WE HAVE EXCELLENT DIALOGUE WHERE
OPPORTUNITIES ARE AND HOW TO
ADDRESS SOME OF THE GAPS AND --
I'M NOT GOING TO CALL THEM
FAILINGS BUT INABILITY TO
PERHAPS MOVE FORWARD IN THE WAY
ENVISIONED.
WHY THOSE HAVE HAPPENED AND HOW
WE MIGHT WORK AROUND THEM BUT I
WAN
WANTED YOU TO HAVE THIS LANGUAGE
IN MIND AS WE DISCUSS THE REPORT
PREPARATION LOOKS LIKE AND
FINALIZE AND COHESION IN THE
REPORT.
I'LL AND IT TO OUR COLLEAGUES AT
NICHD.
>> FIRST I WANTED TO TAKE ABOUT
BEST PRACTICES IN DEVELOPMENT
AND KEEPING IN MIND WHO OUR
AUDIENCE IS.
THIS IS BOTH A REPORT FOR THE
PUBLIC AND CONGRESS AND IT WILL
BE IMPORTANT IN GUIDING US AND
FOR THE PURPOSES OF THIS REPORT,
WITH A LITTLE RELY ON THE TEXT
TO HELP WITH THE NUANCE WHERE
OTHER CLASSIFICATION SCHEMAS
OVER THE LAST MEETINGS MAY NOT
BE THE BEST WAY AND PROVIDE THE
NUANCE THAT WE NEED FOR PUBLIC
AND CONGRESS TO UNDERSTAND HOW
WE'RE FEELING WITH THE
IMPLEMENTATION.
ALSO IN A GROUP THIS BIG THERE
ARE INEVITABLY GOING TO BE
DISAGREEMENTS OR LACK OF
CONCURRENCE.
WE HAVE WAYS TO HANDLE THIS
WITHIN THE REPORT.
IF YOU READ THE ORIGINAL REPORT
YOU'LL NOTICE FOOTNOTES WHERE
THERE WAS AGREEMENT FROM THE
ORIGINAL MEMBERS AND WANT TO
OFFER THE SAME PROCEDURE FOR
THIS REPORT AS WELL.
AS YOU'RE READING THE REPORT YOU
CAN REVIEW YOU'LL REVIEW IN A
COUPLE WEEKS, IF THERE'S PLACES
YOU DISAGREE AND WANT THAT NOTED
PUT THAT BACK TO US SO WE CAN
ENSURE TO PUT THAT IN THE FOOT
NOTE AND WE MEAN IN THE PIECE A
MAJOR DISAGREEMENT ABOUT WHAT WE
PUT IN THE REPORT.
AND THEN JUST KEEPING IN MIND
THE SCOPE OF THE REPORT THAT
WE'RE MEANT TO MONITOR PROGRESS
AND COMMENT ON BARRIERS TO
IMPLEMENTATION OR WAYS IT'S
FALLEN SHORT AND POTENTIALLY
MAKE COMMENTS ABOUT REVISION TO
THE ORIGINAL RECOMMENDATIONS AS
NECESSARY BUT WE ARE NOT MAKING
NEW RECOMMENDATIONS ABOUT HOW TO
INCLUDE PREGNANT AND LACTATING
FOLKS IN CLINICAL TRIALS AND
RESEARCH.
KEEPING IN MIND THE PURPOSES OF
THE GROUP AND SCOPING THAT
APPROPRIATELY IN THE REPORT.
ALSO I'LL STOP THERE TO SEE IF
THERE'S QUESTIONS ABOUT THAT.
>> I DID WANT TO RAISE ONE
COMMENT.
A COMMENT RAISED TO ME IN THE
BREAK AND A GOOD ONE FROM
COLLEAGUES IN THE WORK GROUP AND
GOVERNMENT ENTITIES NOT ABLE TO
WRITE POLICY OR ADVOCACY OR HAVE
A POSITION AND HOW IS THAT TO BE
HANDLED IN THE REPORT?
>> WE TALKED ABOUT THAT.
I THINK WE CAN TALK ABOUT THE
BEST WAY TO HANDLE THAT AS WE'RE
DEVELOPING BUT THAT WILL ALSO
INCLUDE A DISCLAIMER OR FOOTNOTE
THAT SAYS SOMETHING ALONG THOSE
LINES THERE ARE FEDERAL PEOPLE
WHO CONTRIBUTED TO THE REPORT
AND WE'RE LIMITED IN OUR ABILITY
TO COMMENT.
>> IF WE ADVANCE TO THE REPORT
DEVELOPMENT OUTLINE.
CHRISTINA, DO YOU WANT TO TAKE
THIS?
>> SO THE DOCUMENT ITSELF WILL
HAVE FOUR COMPONENTS TO IT.
THERE'LL BE AN OVERVIEW AND
INTRODUCTION WHICH IS GOING TO
HIGHLIGHT QUITE A BIT OF THE
BACKGROUND INFORMATION INCLUDING
THE ORIGINAL PURPOSE OF THE
PRGLAC, WORKING GROUP ITSELF.
WHAT TOOK PLACE IN THE CONTEXT
OF OUR MEETING AND GATHERING
PROCESS WE USED TO MAKE THE
REPORT.
IT WILL BE PRETTY
STRAIGHTFORWARD AND PROBABLY A
BIT OF A REPEAT OF WHAT YOU
HEARD IN THE LAST MEETINGS.
SECTION 2 WILL BE WHERE WE NEED
TO YOU FOCUS INTENSELY BECAUSE
IT'S WHERE WE'RE GOING TO BE
PROVIDING UPDATES ON THE
IMPLEMENTATION PLAN ITSELF AND
WRITTEN WHERE EACH
RECOMMENDATION WILL HAVE ITS OWN
SUBSECTION.
THERE'LL BE CLASSIFICATIONS.
WE'VE STRUGGLED A LOT WITH HOW
TO HANDLE THIS BUT IN GENERAL IT
WILL SAY EITHER A RECOMMENDATION
IS DONE OR COMPLETED.
IT'S IN PROGRESS WHICH MOST THEM
ARE GOING TO BE INNER RANGE OF
IN PROGRESS AND WE KNOW THAT AND
THAT'S WHY EMMA HAS NICELY
SPOKEN TO THE FACT THAT WE NEED
THE TEXT TO CONTEXTUALIZE AND
NUANCE OF HOW PROGRESSED WE ARE
AND SOME NOT STARTED OR MAY NEED
ADDITIONAL CONGRESSIONAL ACTION
AND INCLUDE SPECIFIC
CONSIDERATIONS AND WHERE WE MAY
HAVE SOME RECOMMENDATIONS ABOUT
HOW TO STRENGTHEN AND SEE ACTION
RELATED TO THOSE
RECOMMENDATIONS, THOSE WOULD BE
ONE OF THE PLACES TO SEE THAT
WITHIN THE REPORT.
SECTION 3 WILL BE A SECTION THAT
PROVIDES OVER ARCHING THEMES.
SO IN OUR REVIEW WHEN WE WENT
THROUGH REVIEW OF THE STATUSES
TO DATE SOME THING THAT
DISTILLED TO THE TOP WHICH
IMPACT ALL THE RECOMMENDATIONS
OR SPACE IN GENERAL AND WE'LL
SPEND TIME DEVELOPING THESE OVER
ARCHING THEMES IN THE REST OF
THE SESSION TODAY AND THEN
THERE'LL A CONCLUSION.
SO THE OVER ARCHING THEMES -- DO
YOU WANT TO GO HERE FIRST?
LET'S GO TO THE TIME LINE SO YOU
HAVE AN INFORMATION OF THE WORK
IN FRONT OF YOU AND THEN TO
THEMES.
>> WE'VE LAID OUT THE TIME LINE.
NOTE SOME DATES MAY CHANGE BUT I
DID WANT -- WE ARE WORKING ON A
TITLE TIME LINE SO I DO WANT TO
CALL YOUR ATTENTION TO IN
PARTICULAR A COUPLE UPDATES.
SO AFTER THIS MEETING, MY
COLLEAGUES AT NICHD AND I WILL
GET TO WORK WITH THE HELP OF A
SCIENCE WRITER IN PULLING
TOGETHER THE REPORT.
WE'LL TAKE ABOUT FIVE WEEKS TO
DO THIS OR ABOUT FOUR WEEKS TO
DO THIS AND THEN GIVE THE
CO-CHAIRS AN OPPORTUNITY TO
REVIEW BEFORE SENDING IT TO ALL
OF YOU.
OUR TARGET IS MAY 13 THROUGH 24,
ABOUT 10 DAYS YOU'LL HAVE TO
REVIEW THE REPORT AND THE TIME
LINE IS A LITTLE TIGHT BECAUSE
WE HAVE A DEADLINE WHICH IS OUR
FINAL REPRESENTATION TO COUNCIL,
JUNE 3.
AND THIS IS OPEN TO THE PUBLIC
SO YOU'RE ALL WELCOME TO COME TO
THE PRESENTATION AND HEAR THE
FINAL COUNCIL PRESENTATION.
BUT THEN OUR PLAN IS TO HAVE A
FINAL REPORT SUBMITTED TO
COUNCIL BY THE END OF JUNE THAT
INCORPORATES A LITTLE BIT OF
FEEDBACK THOUGH THAT SHOULD NOT
BE SENSITIVE AND THEN A VERY
FINAL PRODUCT DONE BY THE END OF
JULY.
SO THIS IS A VERY TIGHT TIME
LINE.
AND I'M HOPING YOU CAN ALL STICK
TO THIS MAY 13 TO 24th DATE AND
SUBMIT YOUR COMMENTS IN THAT
PERIOD SO WE HAVE TIME TO
INCORPORATE THEM BEFORE WE
DEVELOP OUR COUNCIL
PRESENTATION.
>> PLEASE PUT IT ON YOUR
CALENDAR NOW, PLAN TO RECEIVE
THE DOCUMENT.
WE NEED EVERYBODY'S FEEDBACK.
WE HAD A QUESTION OFFLINE ABOUT
THE TIME LINE ITSELF.
DO YOU WANT TO SHARE YOUR
QUESTION ABOUT WHAT COMES AFTER
THE REPORT TO CONGRESS?
>> YES, THANK YOU, I FORGOT.
I WAS CURIOUS TO LEARN AFTER THE
FINAL REPORT IS SUBMITTED IF
THERE'S AN OPPORTUNITY FOR THE
AD HOC GROUP TO REVIEW THE WORK
AND REFLECT ON OPPORTUNITIES FOR
ONGOING ENGAGEMENT AND THEN
SECONDARILY, DISTINCT FROM THAT
I WAS CURIOUS IF THERE WAS AN
OPPORTUNITY FOR PUBLIC
COMMENTARY.
I KNOW THE TIME LINE IS VERY
TIGHT SO I CAN UNDERSTAND IT
DIDN'T ALLOW FOR BUT I WAS
CURIOUS TO ASK.
THANK YOU SO MUCH.
>> I CAN ANSWER THE QUESTION
ABOUT PUBLIC COMMENTARY.
THIS IS A WORKING GROUP OF WHAT
WE CALL A FEDERAL ADVISORY ACT
COMMITTEE.
AS A FEDERAL GOVERNMENT AGENCY
THERE ARE CERTAIN RULES THAT WE
HAVE TO FOLLOW WHEN IT COMES TO
NON FEDERAL PEOPLE GIVING THE
FEDERAL GOVERNMENT ADVICE.
AS THIS IS A WORKING GROUP OF
THE COMMITTEE THEY'RE THE ONLY
ONES THAT CAN FORMALLY GIVE
ADVICE TO THE GOVERNMENT IN A
FORMALIZED WAY.
YOU'LL SEE WE'RE PRESENTING THIS
UP TO THE FULL COUNCIL IN JUNE
AND THE FULL COUNCIL WILL BE THE
ONE APPROVING THE
RECOMMENDATION.
I THINK THAT WE WOULD NOT BE
ABLE TO PUT THIS REPORT OUT FOR
PUBLIC COMMENT FOR THAT REASON.
WE CAN CERTAINLY DISCUSS
INTERNALLY IF THERE ARE OTHER
WAYS WHERE WE CAN GET FEEDBACK
FROM THE PUBLIC.
NOT FOR THE PARTICULAR REPORT.
>> AFTER THE REPORT GETS
SUBMITTED TO CONGRESS, IS THERE
AN OUTREACH STRATEGY TO GET THE
REPORT OUT TO THE PUBLIC OTHER
THAN POSTING IT ON THE NIH OR
NICHD WEBSITE?
>> THAT'S SOMETHING WE CAN TALK
WITH FOLKS ABOUT IF YOU GUYS ARE
INTERESTED IN THAT.
WE WERE GOING TO FLUSH IT OUT ON
OUR WEBSITE AND SOCIAL MEDIA BUT
IF OTHER GROUPS ARE INTERESTED
IN HELPING TO AMPLIFY THAT, WE
WOULD WELCOME THAT AND MAYBE
WORK WITH YOU ALL ON JOINT MEDIA
POST OR OTHER THINGS.
>> THE COALITION OF ADVANCED
MATERNAL THERAPEUTICS IS HAPPY
TO WRITE WITH THAT.
WE CAN WRITE EYE NEWS LETTER
BLOG OR POST AND THINGS AND PUSH
OUT AND SUPPORT YOU ALL IN THAT
EFFORT AND OTHER EFFORTS TOO.
>> THIS WORKING GROUP SUN SETS
AFTER THE REPORT IS GIVEN AND
ARE THERE OPPORTUNITIES TO
SUGGEST THERE WOULD BE
RE-EVALUATION OF THE
IMPLEMENTATION?
>> THANK YOU, TINA FOR THAT
QUESTION.
I DID NOT PLAN BUT IT'S BEEN
RAISED BY A BUNCH OF PEOPLE.
THIS -- THINK ABOUT THE TIMING
OF THIS WORK GROUP.
SOME OF THESE THINGS WERE
ACTUALLY STARTED PROBABLY IN
PARALLEL 2 OR WITH THE ORIGINAL
PRGLAC REPORT IN MIND.
SO SOME OF THESE RECOMMENDATIONS
HAVE NOT BEEN ABLE TO MAKE
PROGRESS YET.
IT WOULD BE HELPFUL.
MANY PEOPLE SAID IT WOULD BE
HELPFUL ALSO GET PERHAPS OR NOT
GET BUT TO PLACE A REQUEST THERE
BE ANOTHER REVIEW TO UNDERSTAND
IMPLEMENTATION AND OTHER TIME
POINTS.
SO WITH THIS PIECE WE NEED TO
DEFER TO OUR NICHD COLLEAGUES TO
UNDERSTAND ABOUT MAKING THAT ONE
OF THE FORMAL RECOMMENDATIONS WE
MAKE AS A THEME BECAUSE WE
BELIEVE IT'S EARLY IN THE
IMPLEMENTATION PROCESS THERE MAY
BE ANOTHER ASSESSMENT OF
IMPLEMENTATION IF YOU WOULD LIKE
TO WEIGH IN ON THAT.
>> I THINK IT'S SOMETHING WE CAN
DISCUSS PUTTING FORWARD.
THAT MAKES SENSE.
ESPECIALLY WE MIGHT WANT TO
INCLUDE WHAT WE THINK OR WHAT
YOU ALL THINK THE APPROPRIATE
TIME FRAME.
SIT RIGHT AFTER THE REPORT?
DO WE NEED ANOTHER YEAR TO PASS?
WHAT FOLKS THINKS MAY BE A GOOD
TIME TO REVISIT IF THERE'S BEEN
ADDITIONAL PROGRESS MADE IS JUST
A FEW MONTHS AFTER THE REPORT
ENOUGH TIME?
I DON'T KNOW THE ANSWER BUT I
THINK THAT MAY BE SOMETHING
WORTH INCLUDING.
>> I THINK TO SOME EXTENT THE
TIME LINE TO COME BACK DEPENDS
ON WHAT TIME OVERARCHING THEMES
WE FEEL ARE MOST PRESSING.
IF IT'S OKAY I'D LIKE TO REVISIT
THAT POINT AFTER THE DISCOURSE.
BUT I HAVE THE RECOMMENDATION WE
HAVE REVISIT WITH IMPLEMENTATION
AT SOME POINT.
>> THANK YOU.
I WAS GOING TO SUGGEST IT BE
WRITTEN ALMOST AS A PROGRESS
REPORT BECAUSE SOME OF THESE
ITEMS ARE WHALES, IF YOU WILL.
THEY'RE NOT AC ACTIONABLE AND TO
USE WORDS LIKE PROGRESS REPORT
AND DYNAMIC ITEMS IN THE REPORT
BECAUSE IT WILL TAKE TIME TO
ACHIEVE PROGRESS LET ALONE
FINALITY AND ACHIEVEMENT IN SOME
RECOMMENDATIONS AND TO THINK OF
THEM AS WE GO THROUGH THEM IN
TERMS OF WHAT IS ACHIEVABLE IN A
SMALLER PERIOD OF TIME BUT SOME
ARE NOT.
>> THE COALITION CONTINUES TO
ADVOCATE FOR THE GROUP TO
CONTINUE IN THE YEAR'S
FOLLOWING.
IT WOULD BE HELPFUL FOR FOLKS ON
THE COMMITTEE TO THINK THROUGH
THERE'S FOLKS WE DIDN'T HEAR
FROM.
I THINK WE ARE TALKED THROUGH A
PANEL OF FOLKS AND BEYOND
PROGRESS TOWARDS THE
RECOMMENDATION THERE ARE UNIQUE
THINGS TO YOUR POINT, WHO DOES
THAT BELONG TO?
IT BELONGS TO MANY PEOPLE AND
CAN WE USE THIS GROUP IF IT DOES
HAVE FUNDING TO CONTINUE IN THAT
WAY, IF THAT MAKES SENSE.
>> IT'S HELPFUL IN DEFINING THE
SCOPE.
IF IT WERE TO CONTINUE.
SO FAR THE PROGRESS HAS BEEN
TRACKING IMPLEMENTATION AND IF
THE GROUP FEELS IT COULD
CONTINUE TO TRACK IMPLEMENTATION
AND TO HELP MOVE SOME OF THEM
FORWARD OPPOSED TO CHECKING ON
THE PROGRESS AND DEFINING THAT
SCOPE MAY BE POSSIBLE.
I DIDN'T INTRODUCE MYSELF.
I'M DIRECTOR OF LEGISLATION AND
PUBLIC POLICY AND ETHICS AT
NICHD.
>> DOES THAT ANSWER THE
INFORMATION?
>> YES.
>> WONDERFUL.
>> I WILL MAKE SURE THERE'S ONE
CENTRAL LOCATION THAT HAS ALL
THE MEETING SLIDES AND
SUMMARIES.
THE OTHER SUPPLEMENTAL MATERIAL
AND ONE PLACE FOR YOU BY THE
TIME WE SEND THE REPORT TO
REVIEW.
YOU'LL HAVE ACCESS TO ALL THAT
AS YOU REVIEW.
>> ANY OTHER ADMINISTRATIVE
QUERIES ABOUT THE REPORT
DEVELOPMENT BEFORE WE SPEND THE
REMAINDER OF OUR TIME ON THE
OVER ARCHING THEMES?
SEEING NONE IN THE ROOM AND
ONLINE.
I THINK WHAT WE'LL DO IS GO BACK
A SLIDE TO THESE.
WE SAT DOWN EARLIER THIS WE CAN
A
AND PURPOSELY HIT ON HIGH-LEVEL
THINGS AND TRIGGER A
CONVERSATION.
WE FELT IT WAS IMPORTANT WHEN WE
ARE DEVELOPING THE REPORT WE'RE
UNDERSTANDING THE ESSENCE AND
FLAVOR ON YOUR RESPECTIVES ON
WHAT WILL CRITICAL PIECES TO
MOVE FORWARD AND HOPE WE'LL BE
ABLE TO FOCUS ON CRITICAL
KEEPINGS BUT OTHER COMPONENTS
THAT LIKELY YOU'RE GOING HAVE
INSIGHTS INTO.
SO THE FEW WE LANDED ON THAT WE
WANT TO START THE CONVERSATION
WITH WERE THE FACT THAT WE'VE
HEARD LOUD AND CLEAR IN OUR
PRESENTATIONS THAT THERE'S
DIFFERENCE NOT ONLY IN THE
IMPLEMENTATION PLAN
RECOMMENDATIONS THEMSELVES FOR
PREGNANCY AND LACTATION AND
DIFFERENCES IN THE CHALLENGE IN
PUTTING FORWARD THE
RECOMMENDATIONS AND WANT TO MAKE
SURE VERY MUCH IN THE DOCUMENT
WE CLEARLY ZWSH BET DISTINGUISH
THE TWO AND THAT'S THE FIRST
OVER ARCHING THEME WE WANT TO
LAY OUT THIS IS NOT ALL ONE
POPULATION.
THERE ARE TWO DISTINCT
POPULATIONS AND WE NEED TO MAKE
SURE WE'RE ADDRESSING BOTH OF
THEIR NEEDS.
THE SECOND PIECE IS WE ALSO KNOW
THAT THERE ARE RECOMMENDATIONS
THAT REQUIRE A LOT OF
STAKEHOLDERS TO COME TO THE
TABLE AND THE OWNERSHIP OVER WHO
IS TO BE THE LEADER OR CONVENER
SNOLT CLEAR IN THE
RECOMMENDATIONS.
WE CAN WITHIN THE REPORT TRY TO
ASSIGN OWNERSHIP BUT WE PREFER
TO HAVE THE STAKEHOLDERS COME
TOGETHER AND IDENTIFY THEY ALL
HAVE AN IMPORTANT ROLE TO PLAY
AND IT WILL HELP PROGRESS THIS
FORWARD AT AN EVEN FASTER PACE.
THE OTHER PIECE THAT'S A PART OF
THAT IT'S CLEAR THOUGH WE
LARGELY HEARD FROM OUR PUBLIC
COLLEAGUES, THERE ARE PRIVATE
COMPANIES THAT ALSO NEED TO
ENGAGE IN THIS.
THERE'S A LOT OF PRIVATE
ENTITIES THAT NEED TO ENGAGE AND
HOW DO WE ENSURE THE MESSAGE IS
OUT AND THERE'S WAYS TO DO SO IN
FORUM BEST FACILITATE THE ACTION
AND WE KNOW THERE'S A COUPLE
THINGS THAT ARE NOT LIKELY TO
MOVE FORWARD UNLESS THERE IS
RESOURCE PLACED ON THEM AND THAT
REQUIRES CONGRESS TO ACT.
THAT'S WHERE WE WANT TO START
AND KNOW IT'S NOT EVERYTHING BUT
OUR HOPE IS WE CAN HEAR FROM
EVERYONE THIS AFTERNOON.
YOU MAY SEE THEE KEY THEMES AND
THAT'S FINE.
WE'RE GOING TO PLAN TO GO AROUND
THE ROOM AND HAVE EVERYONE
SPEAK.
BECAUSE YOU MIGHT ALSO HAVE
ADDITIONAL THEMES YOU THINK ARE
MORE IMPORTANT AND SHOULD BE
PRIORITIZED ABOVE WHAT'S HERE.
AND THIS IT GIVES EVERYONE A
CHANCE TO HAVE THEIR SAY AS WELL
FOR THE REPORT.
I'LL STOP THERE AND SUE, I'LL
LEAD YOU TO FACILITATING.
>> SURE.
AND AGAIN WE SAT DOWN AND PUT
PEN TO PAPER AND WHAT WE HEARD
YOU SAYING IN THE FIRST TWO
MEETINGS.
WE'RE NOT GOING PUT ANYBODY ON
THE SPOT BUT WE WANT YOU TO
EITHER MAKE SURE YOU GOT THE
PLATFORM TO VOICE THOSE THINGS
YOU FEEL NEED TO REALLY BE
CAPTURED HERE OR TO UNDERSCORE
WHAT YOU'RE SEEING HERE AS WELL.
I'M GOING TO START ON MY RIGHT
AND AGAIN, I DON'T WANT TO PUT
ANYBODY ON THE SPOT BUT WE'LL
START WITH KARA.
LYNN, SORRY.
>> I THINK THESE THEMES ARE
APPROPRIATE.
I'M NOT SO SURE ABOUT THE BULLET
OF DIFFERENCES BETWEEN LACTATION
AND PREGNANCY AND THEY'RE MORE
SIMILAR THAN THEY ARE DIFFERENT.
I HATE TO BUCKET OUR THEMES OR
HAVE OUR IDENTIFICATION OF
PROGRESS BE SEEN AS EITHER/OR
PITTING THEM AGAINST EACH OTHER
BUT A COHESIVE CONCEPT ACROSS
THE SPECTRUM OF REPRODUCTIVE AND
EMPHASIZING THE DIFFERENCES
COULD DO A LITTLE HARM AND
MAKING ONE LOOK LIKE MAKE MORE
PROGRESS THAN OTHERS BUT NOT
SURE WE NEED TO DISTINGUISH THEM
SO CLEARLY.
I AGREE WITH CONCEPTS BULLETS 2,
3 AND 4.
I THINK THE ADDITIONAL RESOURCES
CONCEPT AND CONGRESSIONAL ACTION
ALMOST IN A WAY SEEMS LIKE THE
OVER ARCHING THEME.
CAN'T DO THIS WITHOUT RESOURCES
AND THE BIG BUBBLE IS
CONGRESSIONAL ACTION AND
RESOURCES IN SOME WAYS AND THE
WAYS IN WHICH THE OTHER CONCEPTS
AND STAKEHOLDERS AND SUCH ARE
DEPENDENT ON RESOURCES TO CARRY
OUT THE OTHER GOALS.
>> I APPRECIATE THE DIFFERENCE
IN PERSPECTIVE AND GIVING US
SOMETHING TO THINK ABOUT IN HOW
IT'S PRESENTED.
>> A LOT OF PEOPLE FELT THE
FOCUS WAS JUST ON PREGNANCY AND
WHY THERE'S BEEN MORE OF A
DEMARCATION AND FROM A CLINICAL
TRIAL THERE'S DIFFERENCES AND
SOME FELT THE POPULATIONS
WEREN'T REPRESENTED.
I WOULD SAY WE NEED TO OUTLINE
THE LIMITATIONS OF THE REPORT.
MOST THE PEOPLE SPEAKING WERE
PUBLIC.
I THINK TODAY WE HAD MORE
VARIETY IN THE TERMS OF
NON-FEDERAL PEOPLE SPEAK BUT IN
TERMS OF ACHIEVING GOALS IT'S
MULTI-TAKE -- MULTI-STAKEHOLDER
RULE AND NEED TO BE AWARE OF THE
POTENTIAL.
>> I WOULD ALSO AGREE
DISTINGUISHING BETWEEN PATIENT
AND PREGNANCY BECAUSE IT'S NOT
BECAUSE OF CLINICAL TRIALS AND
THE TOPICS OF THEM.
OTHERS SEEM APPROPRIATE TO ME
AND WOULD LIKE MORE FUNDING.
>> THANK YOU.
>> SO I GUESS THIS IS THE
NUMBNUM
NUMBERS AND SPLITTERS ARGUMENT.
I'M A PERSON WHO NEEDS TO DIGEST
BUT DISTINGUISHING BOTH
CATEGORIES ARE NEEDED BECAUSE
THEY'RE HISTORICALLY UNDER
REPRESENTED POPULATIONS AND THE
DISTINCTIONS AND MY THOUGHT IS
TO GO WITH DISTINCTIONS AND THE
ISSUE OF OWNERSHIP AND YOU MADE
THE POINT OF KEEPING IT
AMBIGUOUS SO PEOPLE WOULD RISE
TO THE OCCASION TO ADDRESS IT
BUT I WORRY ABOUT ACCOUNTABILITY
THEN AND THE LACK OF
ACCOUNTABILITY WITH SOMEBODY OR
SOME ENTITY.
MAY BE WE NEED TO DISTINGUISH
BUT IT'S GOING TO BE TOO AND OAK
TO PASS THE BUCK AND WE'LL BE
HERE IN THE FUTURE GOING WELL, I
THOUGHT THAT WAS YOU?
I THOUGHT THAT WAS YOU?
IN GENERAL I THINK THESE ARE
FINE.
I KNOW ONE OF MY EARLY COMMENTS
I SHARED IN E-MAIL WAS THE COVID
PANDEMIC WAS UNINTENTIONALLY A
BEAUTIFUL CASE STUDY IN HOW
HORRIBLY WE HAVE NOT ARRIVED AT
ANY OF THESE RECOMMENDATIONS.
IN THIS WORK I'M MORE SENSITIVE
TO THE DETAILED STEPS TO GET US
TO NIRVANA AND I ALMOST WONDERED
IF THERE'S AN OPPORTUNITY TO
POINT OUT HOW GROSSLY WE FAILED
IN INCLUDING PREGNANT AND
LACTATING PATIENTS IN THOSE
STUDIES.
I KNOW THERE ARE ONE OR TWO
EXCEPTIONS BUT BY AND LARGE I
THINK THAT'S A REAL LIFE CASE
STUDY OF HOW MUCH WE FAILED IN
THE AREA.
>> THANK YOU.
I WAS GOING TO MAKE ONE COMMENT
AND MAKE SURE WHEN WE'RE TALKING
ABOUT THE FIRST BULLET FOR
SEPARATING THEM FOR THE SAKE OF
SEPARATING THEM AND MORE TO IT
STRAIGHT THERE'S UNIQUE
CHALLENGES BY THE PREGNANCY
COMMUNITY AND VICE VERSA AND
MAKING SURE IT'S CLEARLY
COMMUNICATE AND THE RESOURCES
MAY BE SLIGHTLY DIFFERENT AND
THE EXISTING POOL OF INDIVIDUALS
ABLE TO ANSWER THE QUESTIONS MAY
BE DIFFERENT.
THAT'S WHERE THE IDEA BEHIND
THAT THEME BUT I'M HEARING WHAT
WE'RE SAYING AND CAPTURING THAT
AND THESE WILL IMPORTANT
CONVERSATIONS TO HAVE.
>> THANK YOU.
I THINK YOU'RE RIGHT IN
PRESENTING IT IN REAL WORLD
LIVED EXPERIENCE.
WE CAN TALK HOW THAT CAN BE
INTRODUCED IN THE BACKGROUND
SESSION AND GROUND THIS IN
REALITY TODAY AND PARTICULAR
SINCE THE PRGLAC TASK FORCE WAS
ESTABLISHED PRIOR TO THE
PANDEMIC.
THAT IS HAPPENING IN REAL TIME
WITH AN IMPLEMENTATION PLAN
WHICH REINFORCES WHY IT'S SO
ESSENTIAL TO GET RIGHT AND PUT
DEDICATED RESOURCE ON TO SEE A
CHANGE.
>> KATIE.
>> I THINK THAT'S RIGHT,
CHRISTINA.
IN THE CONTEXT OF WHERE WE ARE
TODAY VERSUS WHERE WE WERE WHEN
WE STARTED WHICH WAS FORWARD
THINKING AND SAYING WE KNEW THIS
WAS GOING HAPPEN.
I THINK THAT WILL BE REALLY
IMPORTANT TO TIE IT BACK TO WHY
WHY WE NEED TO CONTINUE TO DO
THE WORK.
FROM MY PERSPECTIVE AND THANK
YOU FOR THE CONVERSATIONS
BECAUSE THEY WERE PROMINENT IN
THE INITIAL PRGLAC TASK FORCE
MEETINGS OF WHY WE THESE TO MAKE
SURE WE DO CALL OUT THE
DIFFERENCES OR THOSE
DISTINCTIONS BECAUSE FRANKLY
RESEARCH INTEGRATION AND ALL
THAT IS GOING TO BE IN DIFFERENT
PLACES FOR PREGNANCY VERSUS
LACTATION.
I THINK THE BIGGEST THING FOR ME
IS WITH RESPECT TO THE OWNER
SHIP QUESTION AND BEING CLEAR
FROM SPECIFIC FOLKS OR GROUPS IN
THE ROOM OR NOT IN THE ROOM
SAYING THEY'RE WILLING TO TAKE
CERTAIN THINGS ON AND TYPES OF
GROUPS AND THE INDUSTRY
PERSPECTIVE BECAUSE IT'S A HUGE
PART THAT'S A REALITY WE NEED TO
MAKE SURE ALL OF THOSE
STAKEHOLDERS ARE ENGAGED IN.
IN THE REPORT ONCE THIS GOES
THROUGH THE PROCESS TO HAVE THE
LISTINGS OF ORGANIZATIONS OR
TYPES OF ORGANIZATIONS, THAT
THEN MAKES IT EASIER FOR THOSE
WILLING TO ASSIST TO DO A LITTLE
BIT OF GROUND WORK TO ASSIST AND
PICKING UP WHERE WE CAN MAKE
DIRECTIVES TO CONGRESS OR
FEDERAL AGENCIES.
>> ANITA.
>> SO TWO THOUGHTS FROM ME, ONE
BEING EQUITY NOT IN THE ORIGINAL
RECOMMENDATION AND THINK THEY
FIT WELL UNDER THE EQUITY PART.
I THINK IT'S GETTING MORE AND
MORE SHOWCASED.
THOUGH I APPRECIATE THE
CONGRESSIONAL AGENCY AND FUNDING
BEING EVERYTHING, ON THE OTHER
HAND, THE SCIENTIFIC DISCUSSION
IS SEPARATE FROM THAT SO MY VOTE
WOULD BE TO KEEP THAT SEPARATE.
THE SCIENCE IS ONE TRAIN OF
THOUGHT AND THE FUNDING IS ASIDE
PATH IN MY MIND.
THOSE ARE MY TWO THOUGHTS.
>> SARA.
>> SARAH QUINEY.
AND WHEN STAKEHOLDERS DON'T HAVE
THE FUNDING IT'S AN ISSUE AS
WELL.
ONE THING I'M SEEING AS WE'RE
READING THE GOALS IS WHAT DOES
SUCCESS LOOK LIKE?
WE'RE MAKING INCREMENTAL STEPS
BUT CONSIDER IS NOT A GOOD TERM
BECAUSE IT'S YEAH, I CAN THINK
ABOUT IT BUT THE ANSWER COULD BE
I CONSIDERED IT AND IT'S DONE.
BUT WHAT IS THE SUCCESS HERE AND
I THINK IN SOME CASES YES, WE'VE
ACHIEVE THE GOALS BUT IS THAT
ENOUGH OR IS THERE CONTINUING
SUCCESS AND IT'S NOT ENOUGH TO
ACHIEVE A GOAL BUT KEEP IT IN
THE FOREFRONT TOO.
>> WHAT I WAS HOPING TO UNDER
SCORE FOR ME IN TERMS OF GAPS I
THOUGHT SHOULD BE HIGHLIGHTED
FROM THE REPORT LIKE THE WHO
BUCKET AND HOW BUCKET.
THE WHO MEANING TO HIGHLIGHT
VOICES WE HAVEN'T HEARD FROM YET
LIKE PHARMACY PARTNERS AND SOME
SOCIETIES WOULD BE USEFUL AND
BEHAVIORAL SCIENTISTS AND
COMMUNITY VOICES.
IN TERMS OF THE HOW, LEADING THE
CONGRESSIONAL ACTING TRAINING TO
SPENDING AND THERE'S REPORTS
THAT TALK ABOUT PRODUCED TIME
MORE AVAILABLE TO PEOPLE AND YOU
CAN ONLY SQUEEZE SOMETHING SO
MUCH.
THATS THAT MATTERED TO ME.
AND ONE THING THEY WANTED TO --
I THINK I'LL BE REFLECTING ON IS
TO THINK ABOUT THIS AS AN
OPPORTUNITY FOR RICHNESS RATHER
THAN REFLECTING SO MUCH ON THE
PLACES WE'VE STRUGGLED SO FAR
WHICH TO ECHO YOU IS WHAT WOULD
MY DREAM BE?
IF THE GROUP CAN MAKE SOMETHING
MAGICAL HAPPEN AND STRIKE AN
IMPACT I LIKE WE COULD IS FOR
THIS SPACE TO CONVENE MULTIPLE
STAKEHOLDERS AND IN THE FUTURE
SOME OF THE INTERCONNECTED WITH
THAT STRUGGLED IN THE LAST YEARS
COULD BE SOMETHING THE GROUP
COULD ASK FOR AS A REGULAR
MEETING OR CHECK-IN PROGRESS.
I'LL BE REFLECTING MORE ON WHAT
NIRVANA WOULD LOOK LIKE.
>> I AGREE IN GOING AFTER SO
MANY SMART COMMENTS.
I'M A SPLITTER ON ITEM 1 AND
TALKING ABOUT PREGNANCY AND MAKE
SURE WE'RE ADDRESSING THE
BARRIERS AND CHALLENGES AND
SUCCESSES THERE.
I AGREE WITH WHAT WAS SAID ABOUT
AND WORRIED ABOUT NOT ASSIGNING
OWNERSHIP THING WHEN IT'S
UNCLEAR OR WHO IS RESPONSIBLE
FOR WHAT THOUGH I DON'T KNOW I
HAVE AN ANSWER TO HOW THE
ACCOUNTABILITY IS ASSIGNED BUT
IF THIS GROUP OR ANOTHER GROUP
CONTINUES TO MEET, IS IT A
MATTER OF GETTING THE
STAKEHOLDERS RESPONSIBLE FOR THE
PIECES AT THE TABLE TO THINK OF
HOW TO MOVE FORWARD
IMPLEMENTATION GOING AND I WORRY
WHEN THERE'S GENERAL COMMENTS
ABOUT STAKEHOLDER X WHAT'S THE
INCENTIVE AND IS THERE A WAY TO
BRING THEM TO THE TABLE AS A
MEANS.
I DON'T KNOW -- MAYBE SIMILAR TO
ABOUT WHAT DOES SUCCESS LOOK
LIKE?
I KNOW WE'RE NOT SUPPOSED TO ADD
AN ADDITIONAL RECOMMENDATION BUT
STRIKES ME WANTING TO GATHER
INFORMATION ALONG THE WAY WHEN
THESE THINGS ARE DONE, IS IT
WORKING?
WHEN YOU ENGAGE PROFESSIONALS
AND TALK ABOUT RESEARCH AND DO
WE NEED MORE ENROLLING.
IS THERE SOME WAY TO BUILD IN
THERE SHOULD BE CONSTANT
MEASUREMENT OF WHETHER THE
RECOMMENDATIONS ARE ACHIEVING
WHAT WE WANT THEM TO ACHIEVE AND
I WAS THINKING IF IT'S WORTH AND
MAYBE THIS IS OBVIOUS BUT SOME
OF THESE ARE LARGE
RECOMMENDATIONS.
THEY'LL TAKE YEARS TO BE
SUCCESSFUL AND OTHERS A SHORTER
TIME FRAME.
I'D WANT TO SEE THAT
ACKNOWLEDGED IN HOW
IMPLEMENTATION IS GOING AND HOW
LITTLE PROGRESS MADE AND HOW
MUCH MADE AND WE RECOGNIZE IT'S
A 10 OR 15 YEAR GOAL AND OUGHT
TO HAVE BEEN ABLE TO BE DONE IN
SIX MONTHS OR SOMETHING LIKE
THAT.
>> THANK YOU, KJ.
>> KJ WITH MARCH OF DIMES.
THIS IS A TOOL.
TO THE DEGREE WE CAN APPLY
OWNERSHIP TO THE RECOMMENDATIONS
THE BETTER.
IT GETS CONGRESSIONAL ACTION AND
I THINK WE'LL HAVE TO TALK ABOUT
WHAT IS LOW HANGING FRUIT VERSUS
THE LONG-TERM ACTION ITEMS.
THAT'S GOING TO BE IMPORTANT TO
CONGRESS?
>> AND KEEPING EVERYBODY ON
THEIR TOES AND PARTNERS ONLINE
FIRST.
KEVIN?
>> THE ONLY ADDITIONAL COMMENT
TO WHAT'S BEEN SAID SO FAR IS
THE MULTIPLE STAKEHOLDERS AND
PARTNERS AND GETTING BACK TO THE
FUNDING ISSUE LOOKING BEYOND
NICHD AND ALMOST ALL THE
INSTITUTES HAVE A STAKE IN
PREGNANCY AND LACTATION AND
LOOKING TO EXPAND OUR
PARTNERSHIPS ACROSS INSTITUTES.
>> THANK YOU, KEVIN.
SHARON.
>> I KEEP GETTING BACK TO THE
ACADEMIC VERSUS NON-ACADEMIC
CENTERS.
I WANT TO SAY IS THERE A
SEPARATE PLAN FOR BOTH OF THEM
BRING THEM UP TO SPEED AND PUT
THAT IN A REPORT AND IN AN
ACTION ITEM FOR ACADEMIC CENTERS
AND HOW ARE WE GOING TO BE
EDUCATE AND MOVE THE PLAN
FORWARD.
THEN YOU CAN GO BACK TO CONGRESS
AND SAY THE RESOURCES FOR THIS
ARE GOING TO BE X AND THE
RESOURCES FOR THIS, Y AND HERE'S
THE TRAJECTORY FOR BOTH AND
THEY'RE DIFFERENT.
>> MANY IMPORTANT POINTS HAVE
BEEN BROUGHT UP.
I'LL GO THROUGH MY LIST.
I AGREE WITH POINTS SO FAR AND
AGREE WE SHOULD LOOK AT THE
RECOMMENDATIONS IN TERMS OF THE
CONTINUUM AND TRANSLATIONAL AND
CLINICAL RESEARCH WHERE
APPROPRIATE.
WANT TO MAKE SURE THAT'S
HIGHLIGHTED.
I WAS CAUTIOUS SO FOLKS HAVE
BEEN RAISING THE POINT THIS IS A
PROGRESS REPORT BUT I THINK WE
NEED TO BE CAREFUL ABOUT THE
LANGUAGE BECAUSE WE DON'T WANT
TO GIVE THE IMPRESSION
EVERYTHING IS IN PROGRESS OR
GIVE CREDIT FOR THINGS NOT IN
PROGRESS OR FUNDED AND NEED TO
BE CLEAR ABOUT THE THINGS IN RED
NOT BECAUSE OF THE TIME LAPSED
BUT BECAUSE THERE'S NO
INVESTMENT THERE AND AGREE WITH
SOME POINTS THAT TO THE EXTENT
WE CAN WE SHOULD BE FLAGGING
SOME PRIORITIES.
FOR THOSE THINGS YELLOW OR IN
PROGRESS, LET'S CONTINUE TO
SUPPORT THAT AND FOR THOSE IN
RED, WHAT ARE THINGS WE SHOULD
BE WORKING ON IN THE INTERIM.
>> THANK YOU.
I GOT MY HAND SLAPPED
APPROPRIATELY SO.
PAM, I COULDN'T SEE YOU ON
SCREEN BUT I KNOW YOU'RE THERE.
SORRY I OVERLOOKED YOU.
>> I SUPPORT AND UNDERSTAND THE
CONCERNS BROUGHT UP BEFORE BUT I
DO THINK IT'S IMPORTANT THAT WE
ZWSH THAT POINT AND THE OTHER
THING -- DISTINGUISH THAT POINT
AND THE OTHER THING IS REMOVING
SOME OF THE SILOS BECAUSE I
STILL THINK WE'RE NOT GETTING
THE INFORMATION OUT UNIFORMLY.
IT'S STILL AN ISSUE.
>> THANK YOU.
JANET.
>> BEFORE JANET SPEAKS, CAN I
ASK A QUESTION?
I THINK YOU'RE LOOKING AT
SOMETHING DIFFERENT THAN WHAT WE
SEE ONLINE.
I HEARD SOMEONE TALKING ABOUT
RED AND YELLOW AND GREEN AND ALL
WE SEE IS THE REPORT DISCUSSION
SLIDE.
>> YOU'RE SEEING WHAT WE'RE
SEEING.
I THINKS IT WAS REFERENCE TO
WHAT WE'RE SEEING EARLIER.
>> GOT IT.
JUST MAKING SURE.
>> I SAID SOME FEELINGS BEFORE
WE STARTED ON THIS.
THERE'S A CAVEAT OF
UNDERSTANDING WHAT POINTS CAN BE
CHECKED ALONG AS HAVING MADE
GOOD PROGRESS SERVICE SOME WHICH
ARE ACHIEVABLE AND REQUIRE OTHER
FUNDING ETCETERA.
I DID WANT TO BRING BACK A
PHRASE FROM THE ORIGINAL REPORT
FROM PRGLAC AS A THEME I'D LOVE
TO SEE AT THE TO THE REPORT AND
THAT'S PREGNANT AND LACTATING
PERSONS SHOULD BE PROTECTED
THROUGH RESEARCH NOT FROM
RESEARCH.
AND LET US KEEP THAT AT OUR
FOREFRONT AGAIN BECAUSE THINK
THAT WAS JUST THE TOP LINE GOAL
THAT WE SHOULD CONTINUE ALONG
BECAUSE IT ENCOMPASSES SO MANY
THAEMZ.
-- THEMES.
IN TERMS OF ONGOING DISCUSSION
OF LACTATION AND PREGNANCY I'D
LIKE TO BRING IN THE WORD,
EVIDENCE.
NOT ONLY TO DO THE STUDIES IN SO
PEOPLE BUT THERE'S SO MUCH LESS
EVIDENCE FOR LACTATION AND
SAFETY FOR WOMEN TAKING THEIR
MEDICATIONS WHEN THEY'RE
LACTATING PEOPLE AND I LIKE THE
IDEA THEY'RE SEPARATE WITH THE
IDEA AT THE END WE CAN PULL THEM
TOGETHER BECAUSE THERE'S
SUFFICIENT EVIDENCE AND KEEPING
SCIENTIFIC EVIDENCE AT THE
FOREFRONT IN TERMS QUANTIFYING
PROGRESS.
OWNERSHIP OF RECOMMENDATIONS?
I LOVE THE IDEA OF BRINGING
FORWARD SUGGESTIONS.
I DON'T THINK WE SHOULD HOLD
PEOPLE ACCOUNTABLE AND
RESPONSIBLE BUT IF WE DON'T MAKE
SUGGESTIONS I DON'T KNOW THEY'LL
RAISE THEIR HAND AND I DON'T
MEAN MAKING AN EXHAUSTIVE LIST
OF STAKEHOLDERS.
I THINK WE CAN DO THAT.
AND THE REST IS OKAY.
>> I DO AGREE WITH THESE.
I WANT TO KEEP GOING.
I VIEW 2 AND 3 AS
INTERCONNECTED.
ALMOST ONE BULLET AND
REFLECTING BACK WHAT YOU'RE
TRYING TO SAY AND I COULD BE
WRONG IS THAT PROGRESS HAS BEEN
DIFFICULT BECAUSE THE OWNERSHIP
IS UNCLEAR.
AND THEREFORE A SUBSET BULLET IS
PROGRESS NEED TO BE MADE ON
IDENTIFYING THE MULTIPLE
STAKEHOLDERS INVOLVED.
>> ELENA FROM ORWH.
>> I AGREE THEY'RE DIVERGENT
THEMES AND THERE'S PHYSICAL AND
PHYSIOLOGICAL CHANGES GOING ON
IN THE BODY AND IF WE DO THESE
IT WILL BE MORE EFFICIENT FOR
DEVELOPMENT OF NEW MEDICATION
AND I THINK OWNERSHIP AND
RECOMMENDATION IS ALWAYS HARD TO
TELL BUT AS A FEDERAL AGENCY IT
SHOULD BE GUIDANCE THAT WE
DEVELOP AND HELP STAKEHOLDERS
AND WITHOUT GUIDANCE IT'S HARD
TO RECEIVE AND ANALYZE
SCIENTIFIC DATA AND WHAT WE CAN
DO WITH THIS AND WHO WILL BE
RESPONSIBLE AND HOW THEY'LL BE
COMFORTABLE.
WE ALWAYS KNOW WE HAVE A LOT OF
EFFORTS TO COLLABORATE THROUGH
NIH WIDE AND THIS IS HELPFUL.
WE HAVE A LOT OF EXPERIENCE TO
WORK TOGETHER DIFFERENT I.C.s
AND OFFICES.
I WANT TO SEE WHAT WAS DONE AND
NOT DONE AS DESCRIBED AND
ANALYZE
>> THOSE WILL SHOW UP IN THE
SUBSECTIONS AND RECOMMENDATIONS.
MAYBE SOME PLACES ARE DOING SOME
THINGS BUT WE DON'T KNOW ABOUT
THAT AND IT'S VERY HARD FOR US
AND PHARMACEUTICAL COMPANY WORK
WE DON'T KNOW THEIR EFFORTS.
WE NEED TO BE MORE CLOSE AND
EXCHANGE INFORMATION TO KEEP
THIS TOGETHER.
THANK YOU.
>> MY BRAIN IS TRYING TO PROCESS
NAMES AND WHO WAS ON THE
COMMITTEE.
RACHEL, I'M SORRY.
>> THANK YOU.
I WAS TRYING TO THINK OF WHAT
NEW INFORMATION WE HAVE IT ADD
AT THIS POINT AND THINKING OF
THE WORD PROGRESS AND MAYBE
STATUS.
I'LL LET THE DRAFTERS DECIDE
WHAT THE BEST POINT IS THERE BUT
WHEN LOOKING AT THE STATUS OF
RECOMMENDATIONS AND THAT'S HOW I
WAS THINK ABOUT IT AND
APPRECIATED THE COMMENTS AROUND
THE REALITY OF TODAY AND
THINKING MORE WHAT IS DIFFERENT.
THERE'S A LOT OF DIFFERENT
BETWEEN 2018 AND NOW WHEN THE
RECOMMENDATIONS FIRST CAME OUT
AND THINKING ABOUT THE AUDIENCE
OF THIS REPORT IS ULTIMATELY
GOING TO BE CONGRESS.
BACK IN 2018 WE WERE STILL
HAVING TO CONVINCE MEMBERS OF
CONGRESS MATERNAL MORTALITY WAS
A PROBLEM AND SOMETHING TO BE
PAID ATTENTION TO.
AND WE'RE IN A VERY DIFFERENT
PLACE NOW WHICH THANKS TO THE
FOLKS IN THE ROOM WHO HAVE DONE
THE WORK TO SHOW WHY IT'S A
PROBLEM.
AND THE RATES REMAIN HIGH AND
THERE ARE RACIAL AND ETHNIC
INEQUITIES AND OUTCOME TO BRING
UP THE OTHER ISSUE.
I THINK THAT WILL ALSO BE AN
IMPORTANT AND COMPELLING FRAMING
FOR COMMERCIAL AUDIENCE HOW THIS
RELATES TO IMPROVING MATERNAL
HEALTH AND THE CONNECTION TO
ADVERSE MATERNAL HEALTH
OUTCOMES.
A VOICE THAT WASN'T HERE TODAY
IS ATA CHARO'S AND I'M SURE WE
WOULD HAVE HAD INTERESTING
THINGS TO ADD BUT I REMEMBER IN
AN EARLY MEETING SHE HAD A LOT
TO SAY ABOUT LIABILITY AND WHEN
I WAS SEEING THE MULTIPLE
STAKEHOLDERS, PUBLIC AND PRIVATE
THAT CAME TO MIND.
CHALLENGING THE PERCEPTION WE
CAN'T DO THIS BECAUSE OF
LIABILITY AND PUSHING US PAST
THAT PERCEPTION OR URGING THE
PRIVATE SECTOR TO PUSH PAST THAT
AND I AGREE WITH THE THEMES AND
THINK THERE'S A LOT POTENTIALLY
THERE RELATED TO THE STATUS.
>> CAMILLE.
>> I AGREE WITH MANY THEMES AND
ONE DIFFERENT WAY TO THINK ABOUT
ITEM THEMES 2 AND 3 IS
COMMENTING ON THE IDEA OF
PARTNERSHIPS AND THE IMPORTANCE
OF PARTNERSHIP IN ADVANCING THE
RECOMMENDATIONS AMONG THE
MULTIPLE STAKEHOLDERS AND HOW
THAT IS BEEN EFFECTIVE THUS FAR
AND STILL THESE TO BE EFFECTIVE.
THAT'S ONE THOUGHT.
>> TONY.
>> I'M WITH NOVARTIS PHARMA.
I AGREE WITH PRETTY MUCH ALL THE
COMMENTS MADE SO FAR.
WITH RESPECT TO THE FIRST
BULLET, I'M A SPLITTER TODAY AND
WE HAVE TO SPLIT OUT BETWEEN
LACTATION AND PREGNANCY.
WITH REGARDS TO THE ADDITIONAL
RESOURCES, I THINK MOST PEOPLE
FEEL THAT'S MONEY FOR MOST
THINGS BUT I'D LIKE TO MAYBE
EXPAND THAT TO NOT JUST MONEY
BUT MAYBE OTHER PARTNERS
ESPECIALLY INDUSTRY.
I THINK REACHING OUT TO INDUSTRY
AS A PARTNER COULD HELP FILL
SOME GAPS OUT THERE.
NOT ONLY BASIC SCIENCES BUT
CLINICAL RESEARCH AS WELL.
>> ALISON.
>> ALISON COWAN WITH A
DIAGNOSTICS COMPANY AND OB-GYN
AND SAT THROUGH THESE MEETINGS
MORE SO WITH MY PRACTICING
OB-GYN HAT ON AND IT'S BEEN A
FASCINATING EXPERIENCE.
I DON'T HAVE A LOT OF NEW
RECOMMENDATIONS TO ADD BUT
REFLECTING ON RACHEL'S COMMENTS
PARTICULARLY SURROUNDING HOW THE
RECOGNITION OF MATERNAL
MORTALITY HAS REALLY EVOLVED
SINCE 2018, ONE OF THE REASONS
IT'S SUCCESSFULLY GAINED
ATTENTION LONG OVERDUE IS
BECAUSE WE HAVE MOVED TOWARDS A
BETTER OBJECTIVE MEASUREMENT
THOUGH MANY MUCH YOU IN THE ROOM
READ THE RECENT PAPER QUITE
CONTROVERSIAL.
WE HAVE A LONG WAYS TO GO THERE.
WE STILL ALSO ONLY HAD SIX
STATES OUT OF 50 THAT ARE
REPORTING ON RACIAL INEQUITIES
IN THEIR MMRCs.
A LOT OF PROGRESS YET TO BE
MADE.
I SAY THAT TO EMPHASIZE WHEREVER
POSSIBLE WE CANNOT IMPROVE WHAT
WE DON'T MEASURE AND AS
MENTIONED IN DR. POLLACK'S
QUESTIONS HE CAN TRACK HOW MANY
4 MONTH OLDS BUT NOT SO MUCH
PREGNANCY AND LACTATION.
WE NEED TO DOUBLE CLICK ON
IMPROVING THAT AS A KEY
PRIORITY.
>> AN AGREE WITH WHAT ALLISON
SAID AND IF I REMEMBER IN THE
ORIGINAL MEETINGS, DIANNE SPATS
WOULD RAISE HER HAND EVERY 10
MINUTES AND SAY WHAT ABOUT
LACTATION.
IT WAS ACTUALLY SECOND FIDDLE IN
TERMS OF IT BEING A PRIORITY.
THAT'S A REASON TO KEEP IT
SEPARATE AND MAKE SURE IT GETS
IT'S OWN LANE.
THERE'S ALSO A REASON BECAUSE
OFTEN PEOPLE APPLY DATA ON
SAFETY PREGNANCY AND LACTATION
AND WE DON'T WANT TO LOSE THE
FACT THERE'S SYNERGIES WHEN
RESEARCH IS DONE OR
COMMUNICATION IS DONE MEDICATION
AND THERAPEUTICS AND 90% WILL BE
LACTATING AND THEY CAN BE TIED
TOGETHER IN AN EFFICIENCY WAY
THAT DOESN'T LOSE -- MAKE THESE
TWO SEPARATE ENTITIES AND LOSE
THE OPPORTUNITY TO LOOK AT BOTH
IN THE SAME SETTING SO WE SHOULD
DO BOTH AND THE RECOMMENDATIONS
AGREED, IT'S HARD TO KNOW WHO IS
RESPONSIBLE BUT IF WE CAN SAY
SOMETHING IN THE REPORT THAT IS
A PROCESS RECOMMENDATION WHICH
IS TO SAY AND CAMILLE I THINK
REFERRED TO THIS, IT BEHOOVES IN
IMPLEMENTATION ASSIGNING
OWNERSHIP BUT ASSIGNING
OWNERSHIP TO MULTIPLE
STAKEHOLDERS.
MAYBE NIH AND ADVOCACY GROUCH
AND SOME OTHER GROUP BUT MORE
THAN ONE GROUP TAKES OWNERSHIP
AND WORK TOGETHER AND THAT WILL
LEND TO BETTER SUCCESS AND
IMPLEMENTATION.
>> BECKY.
>> I LIKE TO GO LAST SO I'LL
JUST GO CO-SIGNING.
I APPRECIATE KJ'S FOCUS ON THE
SHORT VERSUS LONG-TERM AND
DELINEATING THOSE 10-YEAR GOALS
VERSUS THE THINGS THAT YOU COULD
HAVE DONE ALREADY.
I DON'T KNOW IF WE WANT TO CALL
IT OUT IN THE REPORT MAYBE WHAT
NEEDS CONGRESSIONAL
AUTHORIZATION VERSUS THE THINGS
THAT COULD BE DONE WITHOUT THAT.
PERHAPS MORE MONEY AND I THINK
THERE'S MOST THE THINGS IN THIS
DON'T NEED EXPLICIT NEW
AUTHORIZATION AND IF THEY DO
IT'S IMPORTANT TO CALL THAT OUT.
I WANTED TO CO-SIGN KEVIN'S
POINT ABOUT MAKING SURE IT'S
BEYOND NICHD, BEYOND NIH.
WHENEVER WE'VE HAD CONVERSATIONS
OUTSIDE OF NIH AND OUTSIDE OF
NICHD, FOLKS ARE LIKE THAT'S
NICHD'S THING, GO TALK TO THEM.
SO MAKING THE POINT THIS IS NOT
JUST ONE INSTITUTE OR AGENCY'S
PROBLEM BUT SOMETHING TO LOOK AT
HOLISTICALLY.
>> SO THIS HAS BEEN REALLY RICH
DISCUSSION.
AND WHAT WE DON'T WANT TO MISS
OUT ON IS THE EXPERTISE WE HAVE
IN THE ROOM OUTSIDE OF THE
WORKING GROUP.
I'LL INVITE OTHER FOLKS IN THE
ROOM THAT MAY WANT TO WEIGH IN.
>> WHEN ELENA TALKED ABOUT
PHYSIOLOGY I'M NOT SURE HOW TO
HANDLE THIS AND COGNIZANT OF
SCOPE CREEP BUT DRAW ATTENTION
TO THE POSTPARTUM PERIOD
IRREGARDLESS OF NURSING OR
LACTATION BECAUSE IT'S A
CRITICAL TIME WHERE MATERNAL
MORBIDITY DEPENDS ON WHEN ONE
DEFINES THE TIME FRAME IS
INCREASED.
THERE ARE A LOT OF CONDITIONS
POSTPART OF UM PERIOD THAT
NEED -- POSTPARTUM TREATMENT AND
HOW MEDICATION ACTING AND
IRRARC
IRREGARDLESS ONE IS CONCERNED
ABOUT THE TRANSFER AND A LOT OF
THE CHANGES THAT OCCUR DURING
PREGNANCY ARE NOW REVERSING
GOING BACK TO THE PREVIOUS STATE
BUT NEW PHYSIOLOGICAL STATE AND
WE DON'T HAVE A FULL
UNDERSTANDING OF THE CHANGES.
ADDITIONALLY TREATMENT OF
POSTPARTUM HEMORRHAGE AND
DEPRESSION IS SOMETHING ELSE TO
CONSIDER AND COGNIZANT OF
POTENTIAL SCOPE CREEP BUT I
DON'T THINK WE'RE GOING HAVE IN
15 YEARS THE POSTPARTUM
INITIATIVE.
I THINK THIS IS AN OPPORTUNITY
AND MAYBE PERHAPS IT'S MORE
CONDITIONAL BUT WANT TO DRAW
THAT ATTENTION TO THE WORKING
GROUP.
>> DOES ANYONE ELSE HAVE
COMMENTS THEY WANT DO SHARE.
>> I'M SNEAKING IN.
I LITERALLY SNUCK IN.
I'M THE DEPUTY DIRECTOR OF NICHD
AND I HAD A LOT MORE TIME
BLOCKED TODAY TO BE OVER HERE
BUT AS YOU ALL MAY KNOW WE GOT A
BUDGET YESTERDAY BUT WE ARE ALSO
PENDING A POTENTIAL SHUT DOWN
TOMORROW.
SO THE NEAT THING WE'VE BEEN
DOING TODAY IS FIGURING OUT WHAT
MONEY WE MAY HAVE AND WHO WE'RE
PULLING BACK FROM TRAVEL
SIMULTANEOUSLY.
I WANT TO APOLOGIZE FOR NOT
BEING HERE MORE TODAY.
THIS IS AN INCREDIBLY IMPORTANT
DISCUSSION FOR US AND YOUR
DEDICATION AND FORTITUDE IN
BEING HERE AND EVERYBODY IN THE
ROOM WE APPRECIATE AND THANK YOU
CHRISTINA AND SUSAN FOR YOUR
LEADERSHIP OF THE GROUP BECAUSE
FROM EVERYTHING I HAVE HEARD
FROM THE DISCUSSIONS HAS BEEN
PIVOTAL.
WE WANT TO THANK YOU AND ALSO
THANK ALL THE STAFF THAT HAVE
BEEN SUPPORTING THIS WHILE
SIMULTANEOUSLY SUPPORTING
EVERYTHING I SAID ABOUT THE
BUDGET AND LEGISLATION AND
TECHNICAL AND ALL THE THINGS.
NATASHA AND LAURA HAVE DONE A
GREAT JOB AND THE LAST POINT,
REBECCA, WE HAVE THE LARGEST
MATERNAL HEALTH PORTFOLIO AND
THE LARGEST FUNDER OF LACTATION
RESEARCH.
HAVING THAT SAID NOW HAVING
WORKED ON MATERNAL HEALTH ALMOST
FIVE YEARS NOW, WE WORK A LOT
WITH OUR SISTER I.C.s AND WHEN
ELENA WAS SPEAKING WE WORK
DIRECTLY WITH ORWH AND THE WORK
ON DEPRESSION HAS MOVED THE
TRIALS FORWARD.
WE WORK CLOSELY WITH HEART, LUNG
AND BLOOD AND NIDDK.
TO THE EXTENT YOU TAKE THE
MESSAGES TO THE OTHER I.C.s AND
IMPORTANCE OF PREGNANCY AND I
THINK WE HAVE A GREAT CHAMPION
AT NAID NOW.
SHE HAS BEEN TREMENDOUS TO WORK
WITH TO START UP.
I THINK YOU'RE SEEING A CHANGING
FACE WITH WOMEN IN LEADERSHIP
AND HAVE MORE RECEPTIVITY WHICH
IS A GREAT CHANGE HERE AND
WITHIN THE NEW NIH DIRECTOR
BEING A WOMAN A LOT MORE
INFORMATION OF WHAT THE ISSUES
ARE AND WHAT WE CAN DO.
SO DON'T SHY AWAY FROM REACHING
OUT.
WE DON'T HAVE TO OWN ALL OF IT
BECAUSE WE DON'T OWN ALL THE
CONDITIONS AND IT'S GREAT TO
WATCH US GET OTHER CHAMPIONS FOR
THIS CRASS THE NIH.
WE ALSO WORK CLOSELY WITH HHS
AND MANY ISSUES AND KNOW WE'RE
ADVOCATING WHERE WE CAN WITH
OTHER AGENCIES GET CONTROL AND
ADVOCATE AND OUR BUILDING CLOSE
RELATIONSHIPS TO TRY TO MAKE
SURE THE ISSUES ARE AT THE
FOREFRONT.
I WANTED TO COME AND SAY THANK
YOU.
AND WE HAVE A 4:00 MEETING ON
WHO WE NEED TO PULL OFF TRAVEL
OR MAY BE ABLE TO TRAVEL IF THE
BUDGET PASSES BY X TIME.
THIS IS THE FUN PART OF BEING A
GOVERNMENT SERVANT PEOPLE, DON'T
BE JEALOUS.
I WANTED TO MAKE SURE I CAME
OVER AND SAY HELLO.
THANK YOU FOR THE TIME.
>> SO I'LL ENCOURAGE OUR WORKING
GROUP TO LOOK AT THE REPORT
CAREFULLY AS IT'S DRAFTED.
THE THEMES NOT RELEVANT TO A
SPECIFIC RECOMMENDATION WILL
WIND UP IN AN OVERARCHING THEMES
AREA.
SOME THINGS WE TALK ABOUT TODAY
MAY WIND UP UNDER SPECIFIC
RECOMMENDATION AND WON'T BE LOST
BUT CAPTURED WHERE IT'S RELEVANT
FOR THEM TO BE.
CHRISTINA DO YOU HAVE ANYTHING
ELSE TO ADD?
>> I JUST WANTED TO SAY YOU SAW
ME TAKING FURIOUS COMMENTS AND
YOUR COMMENTS ARE CENTRAL TO THE
REPORT AND I REINFORCED ONE
PIECE SOMEONE SAID THE OWNERSHIP
OF COURSE BUT THE IMPORTANCE OF
PARTNERSHIP AND IT'S TO GO
BEYOND ONE AND PARTNERSHIP MEANS
SO MANY THINGS WITH SO MANY
PEOPLE AND I WANT YOU TO LOOK
AROUND THE ROOM AN IT'S CLEAR
THERE IS A MOVEMENT THIS IS
PROGRESS HAVING US AT THE TABLE
AND SHARED OBJECTIVE AND
TRANSLATE THAT TO A REPORT TO
CONGRESS TO UNDERSTAND WHAT
KEEPS THE MOVEMENT GOING FORWARD
AND FOMENTING CHANGE.
I WANT TO THANK YOU GUYS ALL FOR
THE LAST HOUR BECAUSE I THINK
THIS WAS ESSENTIAL TO MAKING
SURE WE'VE GOT THE CONTEXT
RIGHT.
>> BECAUSE OF THE ROUND ROBIN
NATURE OF THE FINAL COMMENTS I
DON'T KNOW IF ANYONE ELSE MADE
COMMENTS AND I WANTED TO SAY
SOMETHING BUT MAYBE NOT ADD ON
BUT A DIFFERENT IDEA AND CAN I
SHARE THAT NOW REAL QUICK?
IT MAY HAVE BEEN RACHEL.
SOMEBODY SAID HOW IN THE FIRST
MEETING THERE WHERE THERE WAS
RELIABILITY I DON'T KNOW IF IT'S
AN ATTORNEY OR PATIENT.
I REALIZED I'VE DONE MY PEOPLE A
DISSERVICE AND DOING THE
ADVOCACY WORK LONG ENOUGH I LOST
MY NAIVE PATIENT PERSPECTIVE BUT
BECAUSE OF THE WORK I DO I'M
ALWAYS TALKING TO SURVIVORS AND
FAMILY MEMBERS NOT SURVIVORS.
I'LL PUT MY HAT BACK ON THAT
SAYS WHAT THE WHOLE
INITIATIVE -- HOW IT MIGHT
RESONATE TO A VARIETY OF NAIVE
PATIENTS.
I DO THINK IN OUR SUMMARY THERE
NEEDS TO BE A STATEMENT OR
PARAGRAPH TRULY WRITTEN NOT IN
THE TECHNICAL LANGUAGE OF
TODAY'S SESSION.
THIS IS TECHNICAL INFORMATION
WE'RE COVERING AND A NAIVE
PERSON WOULD LOOK AT THIS AND
SAY, WAIT A MINUTE ARE WE
PUTTING MY BABY AT RISK BECAUSE
LET ME REMIND YOU WE WOULD STILL
FALL IN FRONT OF A TRAIN FOR OUR
UNBORN CHILDREN.
THAT'S A REALITY FOR MANY
PEOPLE.
THAT'S SERVING AS THE BACKGROUND
TO ALL OF THIS DISCUSSION
THERE'S WAYS TO DO THIS SAFELY
AND WAYS SCIENCE HAS ADVANCED TO
THE POINT WE CAN DO THINGS TO
PROTECT AND ANSWER THOSE
PROTECTION QUESTIONS.
AND A LAY LANGUAGE KIND OF WAY
IN THE REPORT THAT ADDRESSES
THAT.
NOT JUST THE HISTORIC REASONS
WHY PREGNANCY RESEARCH HAS
FALTERED BUT WHY WE'RE NOW AT A
PLACE TO REINVIGORATE IT IN A
SAFE WAY THAT PROTECTS BOTH
PATIENTS.
>> IF WE EXPRESS ALTERNATIVES
AND THE REGISTRY WHERE YOU'RE
NOT LOOKING AT A GROUP OF
DISEASES AND DRUGS TAKEN FOR IT,
I THINK IT HELPS IN MAKING THE
POINT OF PROVIDING ALTERNATIVES
AND IT'S NOT ALL OR NOTHING.
>> THANK YOU FOR OPENING TOPICS.
YOU HAVE ME CONVINCED OF
LACTATION AND PREGNANCY
POTENTIALLY BEING SEPARATE.
HOWEVER, I WANT TO REFLECT ON
SOMETHING AARON AND TINA BROUGHT
UP ON THE CONCEPT OF A CONTINUUM
AND POSTPARTUM HEALTH WHICH IS
SOMETHING I THINK ABOUT AS AN
SMFM IS THE PROBLEM OF WOMEN AS
VESSELS ONLY BE STUDIED FOR SAKE
OF THE CHILD AND I THINK MANY
DISLIKE THAT PROBLEM WHERE THE
PERSON IS ONLY CONSIDERED
VALUABLE FOR HER ROLE AS A
GESTATOR OR FEEDER OF AN INFANT.
I WANT TO BE THOUGHTFUL WHEN WE
DIVED OUT PREGNANCY AND
LACTATION AS PRIORITIES AND
AVOIDING THAT ISSUE AND NOT
MAKING IT SEEM LIKE LACTATION
RESEARCH IS IMPORTANT ONLY
BECAUSE SHE'S A FEEDER OF AN
INFANT AND RESEARCH IN THE
LACTATING PERSON CAN BE
IMPORTANT FOR THEIR HEALTH AS
WELL.
I THINK THERE'S AN IMPORTANT
NUANCE THERE THAT MAYBE HASN'T
BEEN TOTALLY ADDRESSED YES
BECAUSE WE'VE BEEN FOLK OF --
FOCUSSED ON THE CONCEPT OF
THERAPEUTICS AND MEDICATION.
THERE'S OTHER AREAS FOR CLINICAL
TRIALS THAT AREN'T JUST DRUGS
THAT FOCUS ON THE PEOPLE WHO MAY
BE LACTATING.
AND WOMEN ARE IMPORTANT TOO NOT
JUST FETUSES.
>> IT'S A GREAT POINT.
>> WHEN THERE'S COMPLICATIONS
THAT COULD BE EXTENDED
CONSEQUENCES TO MATERNAL HEALTH
THROUGHOUT THEIR LIFE SO YES,
THEY'RE NOT JUST VESSELS FOR
PREGNANCY.
>> AND WHEN PEOPLE BRING IN THE
MEDICAL CONDITIONS THEY'VE BEEN
LIVING WITH.
I WAS CURIOUS ABOUT CURIOUS IF
LEARNING IF THERE'S A TIME LINE
FOR NATIONAL ACADEMIES HOW TORY
LEASE THE REPORT AND HOW TO NOT
CONFUSE THE LAY PERSON OR PUBLIC
WHAT THE TWO DIFFERENT GROUPS
ARE DOING AND MAKE IT CLEAR WHAT
WE ARE ABOUT.
AFTER HEARING EVERYONE SHARE
THEIR THEMES THAT THAT SEEMS TO
RESOUND I FEEL YEAR SAY
REASONABLE TIME BUT I'M HAPPY TO
BE CORRECTED IF WE NEED LONGER
OR SHORTER.
>> WE'LL HAVE A BRIEFING AFTER
THE REPORT IS RELEASED.
SO THE REPORT WILL BE PUBLIC BY
THE TIME WE HAVE THAT BRIEFING
APRIL 16.
OUR INTENTION IS TO BRING THAT
INTO THE REPORT.
WE'RE GRATEFUL TO THEM THEY WERE
ABLE TO SCHEDULE THAT IN A TWHA
WORKED WELL WITH OUR REVIEW TIME
LINE.
I'VE GOTTEN A COUPLE QUESTIONS
FROM FOLKS WHO DIDN'T MAKE IT
AND WE'RE FIGURING OUT HOW TO
GET RECORDING IF YOU CAN'T MAKE
IT LIVE.
>> WE HAVE RECOMMENDATION 7
WHICH WOULD BE CONTINGENT ON THE
CONSETENT OF THE REPORT.
>> THERE'S A NATIONAL ACADEMIES
GROUP MEETING ON LACTATION AS
WELL THAT'S COMING UP.
IT'S ABOUT INITIATION OF
BREASTFEEDING THAT MAY BE
RELEVANT.
I DON'T KNOW HOW SOON IT WILL BE
COMPLETED.
>> ANY OTHERS WHO WANTED TO
PROVIDE ANY COMMENT?
SEEING NONE --
>> IT'S MORE OF A QUESTION WITH
THE FINAL REPORT.
I WONDER IF YOU CAN DESCRIBE THE
REPORT AND A RECOMMENDATION AND
UPDATE?
WILL I LOOK AT BOTH REPORTS
TOGETHER?
DO YOU SEE WHAT I'M SAYING?
I DON'T KNOW.
HOW ARE WE LAYING THIS OUT?
IT'S TO HAVE A RECOMMEND AND
UPDATE.
WE'LL HAVE THE ORIGINAL TEXT
FROM THE ORIGINAL PRGLAC REPORT
AND UPDATE.
>> IF IT'S THE GENERAL CONSENSUS
OF THE GROUP THE PROGRESS IS X
AND THERE'LL BE DISSENT CLEARLY
SPELLED OUT AND WE'LL USE THE
TEXT TO MAKE SURE WE DISCUSS THE
NUANCES, CAVEATS SO FOLKS ARE
CLEAR ABOUT WHAT WE'RE TRYING TO
SAY.
THE ONLY THING I WILL ADD TO
THAT IS YOUR POINT SAY VERY
IMPORTANT ONE AND WORK ON
MULTIPLE CONSENSUS DOCUMENT AND
WE'LL DO OUR BEST TO ENSURE IT'S
CLEAR AND IT'S A DOCUMENT THAT
HAS FOUNDATIONAL COMPANION
DOCUMENT TO UNDERSTAND SOME OF
THE NUANCE YOU NEED TO BE
FAMILIAR WITH THOSE.
BUT I DON'T THINK IT WOULD MAKE
A LOT OF SENSE FOR US TO REPEAT
THEM BECAUSE THEN THEY'LL GET
[LAUGHTER]
ON WHAT THE KEY MESSAGES ARE.
-- LOST ON WHAT THE KEY MESSAGE.
>> ANY FINAL THOUGHTS FROM THE
GROUP?
ALL RIGHT.
SO BRAVO.
WE'RE AHEAD OF SCHEDULE BUT WE
ALSO SKIPPED A BREAK SO THAT OUT
WELL.
IN CONCLUSION, THERE'S THE CALL
SCHEDULED FOR APRIL 16 AND WE
WILL GET THE UPDATE ON THE NIAMS
REPORT FOR THE WORKING GROUP AS
WAS OUTLINED ALL OF YOU THE
REPORT TO COUNCIL IS JUNE 3.
IT'S OPEN AND YOU CAN DIAL IN
AND HEAR THE REPORT ITSELF AND
THE DOCUMENT WILL BE FINALIZED
POST THE PRESENTATION OF COUNCIL
WE'LL HAVE AN OPPORTUNITY TO
MAKE REVISIONS AS A RESULT OF
THE PRESENTATION AND I WANT TO
ON BEHALF OF SUE AND MYSELF AND
THE WORKING GROUP PLEASE HELP ME
IN THANK EMMA AND LAURA AND
NATASHA BECAUSE THEY'VE BEEN OUR
SAGE GUIDES WHICH WE WOULD NOT
BE HERE WITHOUT.
THANK YOU VERY MUCH.
I ALSO WANT TO THANK ALL OF YOU
WHO PRESENTED YOU'VE BEEN
WONDERFUL BECAUSE WE'VE ASKED
YOU FOR STATUS AND FACILITATE
WORK AND HAVE A REPORT
MEANINGFUL TO CONTINUE THE WORK
AND FACILITATED AND IT'S LOVELY
TO SEE YOU ALL IN PERSON.
WE I THINK WE WORKED NICELY
VIRTUALLY.
THIS IS A REALLY TOUGH TASK TO
BE IN A WORKING GROUP REVIEWING
STATUS WHEN WE KNOW THERE'S MORE
GOING ON BUT HAVE A SHORT PERIOD
OF TIME TO BRING THINGS TOGETHER
SO THANK YOU FOR YOUR
WILLINGNESS IN A SHORT PERIOD OF
TIME TO PUT ALL THIS EFFORT IN
AND MAKE SURE WE HAVE SOMETHING
MEANINGFUL COMING OUT OF THE
BACK END AND THE HARD WORK OF
THE DOCUMENT TO COME.
I LOOK FORWARD TO OUR CONTINUED
COLLABORATION.
REACH OUT IF YOU HAVE QUESTIONS.
EMMA ALWAYS RESPONSES WITH THE
FIVE NAMES IN THE CC SO PLEASE
DO REACH OUT TO THE GROUP AND
NATASHA AND LAURA AND SUE AND
MYSELF IF YOU HAVE ANY QUESTIONS
AT ALL AND THANK YOU.
>> FINAL LOGISTIC COMMENTS FROM
EMMA.
>> I APSALM YOU -- ASSUME YOU
ALL WANT TO GO HOME SO IF YOU
NEED -- YOU'RE ACTUALLY GOING TO
THE SAME PLACE THE METRO.
AND YOU CAN THERE PICK UP THE
METRO AND/OR A CAB OR REFER TO
YOUR VARIOUS DESTINATIONS POST
THIS MEETING BUT THAT ALSO
REMINDS ME ALSO NEED TO THANK
LESLY AND OTHER COLLEAGUES FOR
MAKING SURE PEOPLE GOT HERE.
I APPRECIATE YOU, LESLY, THANK
YOU.
IF YOU HAVE ANY OTHER LOGISTICAL
QUESTIONS WE'RE HERE TO ANSWER
THEM AND APPRECIATE ALL THE
EFFORTS YOU ALL MADE TO GET HERE
TODAY.
THANK YOU.