HELLO, EVERYONE AND THANK YOU SO
MUCH FOR BEING THIS AFTERNOON OR
THIS MORNING DEPENDING WHERE IN
THE COUNTRY YOU'RE CALLING IN
FROM.
MY NAME IS EMMA CARPENTER THE
NICHD STAFF COORDINATOR OF THE
PRGLAC WORK GROUP OF THE NICHD
COUNCIL.
I'M LOOKING FORWARD TO DIVING
INTO OUR IMPORTANT WORK THIS
AFTERNOON AT OUR SECOND MEETING
OF THIS WORK GROUP.
BEFORE I INTRODUCE OUR CO-CHAIR
I'D LIKE TO GO OVER A FEW
HOUSEKEEPING ITEMS.
FIRST, TO THE WORKING GROUP
MEMBERS, THANK YOU SO MUCH FOR
JOINING US AND FOR YOUR TIME AND
EFFORT TODAY.
FOR THE DURATION OF YOUR MEETING
IF YOU ARE NOT SPEAKING, PLEASE
KEEP YOUR CAMERA OFF AND
MICROPHONE ON MUTE BUT DURING
THE QUESTION AND ANSWER
SESSIONS, IF YOU ASK A QUESTION
OR COME ON TO COMMENT, PLEASE DO
PUT YOUR CAMERA ON AND TAKE
YOURSELF OFF MUTE AND YOUR ALSO
WELCOME TO USE THE CHAT FEATURE
AT ANY TIME.
THIS IS A PUBLIC MEETING VIA NIH
VIDEOCAST KEEPING VIDEOS OFF
KEEPS IT MORE STREAMLINED AND
SOME HAVE STATED CONFLICT AND WE
DO NOT FEEL THIS WILL
NECESSITATE SOME RECUSING
THEMSELVES FROM THE
CONVERSATION.
WITH ALL OF THAT, I'D LIKE TO
TURN IT OVER TO OUR CO-CHAIRS,
THANK YOU BOTH FOR YOUR
LEADERSHIP.
>> THANK YOU, EMMA.
SO I'LL BEGIN IF WE CAN GO TO
THE NEXT SLIDE.
JUST TO ORIENT OUR WORKING GROUP
MEMBERS AND TO OUR PUBLIC
PARTICIPANTS TO WHERE WE'VE BEEN
IN THIS WORKING GROUP SO FAR.
GO BACK ONE SLIDE.
SO YOU'LL RECALL THE FIRST
MEETING IN NOVEMBER WE REVIEWED
RECOMMENDATIONS 12 AND 13 OF THE
IMPLEMENTATION PLAN FOR PRGLAC
PROVIDED TO CONGRESS.
DURING THAT DISCUSSION, WE
REVIEWED THE RECOMMENDATIONS FOR
THE PROGRESS THAT'S BEEN MADE TO
DATE AS IT RELATES TO PREGNANCY.
YOU'LL SEE WE HAVE PROGRESS MADE
TOWARDS RECOMMENDATION 12.
FOR RECOMMENDATION 13 THERE'S
STILL WORK TO BE DONE BUT WE'RE
MOVING FORWARD AND WE CAN REPORT
THE STATUS OF DATES AS THEY
PERTAIN TO THESE TWO
RECOMMENDATIONS.
WHAT WE DISCOVERED WHEN WE WERE
HAVING THE CONVERSATION
REGARDING RECOMMENDATIONS 12 AND
13 FOR LACTATION, WE ARE FURTHER
BEHIND AND THERE WILL BE
NECESSARY STEPS TO PUT IN PLACE
TO SEE THE RECOMMENDATIONS FULLY
IMPLEMENTED FOR PATIENTS WHO MAY
REQUIRE MEDICATIONS DURING
LACTATION.
JUST TO REVALENCE WHAT THE
INTENTIONS RF THIS WORK GROUP AS
WE CONTINUE OUR ACTIVITIES
THROUGH MAY 2024, THIS IS A WORK
GROUP THAT HAS BEEN PUT IN PLACE
AS A RESULT OF INACTION WHERE
THE COMMITTEE'S INTENTION IS TO
MONITOR AND REPORT ON THESE
IMPLEMENTING GUIDELINES PLACED
IN THE PRGLAC REPORT TO
CONGRESS.
THIS INCLUDES OUR REVIEWING WHAT
PURPOSE HAS BEEN MADE IN REGARDS
TO REGULATIONS, WHAT'S PROCEEDED
IN TERMS OF GUIDANCE THAT'S BEEN
DEVELOPED.
ANY OF THE SOCIETY WORK THAT'S
BEEN DONE.
ANY OF THE PROFESSIONAL WORK
THAT'S BEEN DONE AND ANY OF THE
GOVERNMENT AGENCY WORK THAT'S
BEEN DONE.
OUR INTENTION IS NOT TO CALL
THIS A PRINCIPPRINCIPAL'S REPOR
WILL REQUIRE TIME AND EFFORT FOR
THE RECOMMENDATIONS TO BE FULLY
IMPLEMENT.
OUR TASK SAY DIFFICULT ONE WE
HAVE TO ASK MEMBERS OF CERTAIN
AGENCY TO PROVIDE A LITTLE
INSIGHT INTO WHAT'S HAPPENING
THERE.
THEY CAN'T POSSIBLY REPORT ON
THE EXTENT OR SCOPE OF WORK
THAT'S BEING DONE ACROSS THE
AGENCY SPACE AND IN THE PRIVATE
SECTOR BUT WE ARE ASKING THEM AT
LEAST TO PROVIDE US SOME
INSIGHTS INTO HOW WE'VE BEEN
PROGRESSING SO FAR WITH SPECIFIC
RECOMMENDATIONS.
SO WE DO HAVE VERY SPECIFIC
OBJECTIVES AS A WORK GROUP.
OUR OBJECTIVE IS TO IDENTIFY AND
INVITE SPECIFIC SPEAKERS FROM
RELEVANT FEDERAL AGENCIES OR
ENTITY TO DISCUSS PROGRESS
TODAY.
OUR WORKING GROUP IS ABLE TO
DISCUSS FURTHER WHAT IN ADDITION
MAY BE REQUIRED TO FULLY ACTION
THOSE RECOMMENDATIONS.
ADDITIONALLY, IT'S REALLY
IMPORTANT FOR US TO LOOK AT WHAT
BARRIERS MAY BE IN PLACE OR WHAT
ADDITIONALLY MAYBE NEEDED TO
FULLY RECOGNIZE THE
IMPLEMENTATIONS AND PROVIDE A
REPORT TO CONGRESS.
THIS IS A PRETTY QUICK PROCESS.
WE CAN'T POSSIBLY REVIEW ALL OF
THE POSSIBLE THINGS THAT HAVE
BEEN PUT IN PLACE IN REGARDS TO
THIS RECOMMENDATION BUT WE DO
OUR BEST TO PROVIDE A FLAVOR TO
WHAT IS PROGRESSING.
FROM HERE I'LL TURN THINGS OVER
TO SUE TO PROVIDE THE REST OF
THE INTRODUCTION.
>> THANKS, CHRISTINA.
AS A REFRESHER THE
RECOMMENDATIONS OUR WORKING
GROUP HAS BEEN TASKED WITH
REVIEWING HAVE BEEN GROUPED INTO
FIVE CLUSTERS.
YOU'LL RECALL WE SUCCESSFULLY
REVIEWED OUR CLUSTER D FOLLOWED
BY THE ELEMENT OF THE WORK OF
OUR PROGRESS.
TODAY WE'VE GOT A BIT MORE OF
THE HEAVY LIFT AS WE'LL BE
COVERING CLUSTERS A, E AND C.
CLUSTERS A AND E WILL BE
DISCUSSED IN OUR FIRST SESSION.
THESE INCLUDE RECOMMENDATIONS 2,
8, 9 UNDER THEME OF RESEARCH AND
RESOURCE FUNDING AND ALLOCATION,
PRIORITIZATION PROCESS
DEVELOPMENT AND IMPLEMENT OF
NOVEL STRATEGIES AND
FACILITATION OF COLLABORATION.
AS SUCH THE PLANNING TEAM FELT
THE NICHD CAN OFFER THE MOST
COMPREHENSIVE INSIGHTS AND WE'LL
HEAR FROM THEM IN THE FIRST HOUR
OF MEETING.
IN SESSION TWO WE'RE GOING TO
COVER CLUSTER C.
AND THIS CLUSTER INCLUDES
RECOMMENDATIONS 1,4, 7 AND 10.
AS YOU RECALL FROM YOUR MEETING
THESE RECOMMENDATION CENTER ON
HARMONIZATION, GUIDANCE DOCUMENT
DEVELOPMENT, FDA AUTHORITY,
SPONSOR AUTHORITY AND
CONTINGENCY OF PLANNING.
WE RECOGNIZE THESE
RECOMMENDATIONS TOUCH A NUMBER
OF SECTORS AS CHRISTINA
MENTIONED BUT WITH THE LIMITED
TIME WE HAD WE FELT HEARING FROM
COLLEAGUES AT THE FDA WOULD
AFFORD THE BEST OVERVIEW.
WE'LL BE HEARING FROM THEM
DURING SESSION 2.
NOW, BEFORE WE BEGIN I WANTED TO
BRING YOUR ATTENTION TO THIS
GRAPHIC WHICH YOU SAW AT THE
FIRST MEETING AND CHRISTINA
INTRODUCED AGAIN TODAY WHERE WE
SEE AN OVERVIEW OF ALL THE
RECOMMENDATIONS AND IF YOU
RECALL FROM THE LAST MEETING WE
SUBSEQUENTLY DRILLED TO A
SIMILAR GRAPHIC THAT HAS EACH OF
THE SUB RECOMMENDATIONS.
AND THERE ARE TWO IMPORTANT
NOTES FOR TODAY.
THE FIRST IS THAT WE HAVE TABLED
SELECTED SUB RECOMMENDATIONS FOR
REASONS WE'LL EXPLAIN WHEN WE
GET TO THAT PARTICULAR SECTOR
AND RECOMMENDATION.
INSTEAD OF BLUE AS YOU SEE IT
HERE THEY'LL APPEAR DARK GREEN
AND WILL NOT BE DISCUSSED ON THE
LINE TODAY BUT WE CAN HAVE A
CONVERSATION ABOUT THEM OFFLINE.
THE SECOND IS WE WILL NOT BE
ADJUDICATING COLOR ASSIGNMENTS
TODAY LIKE WE DID IN THE FIRST
MEETING.
WE FELT IT WOULD BE MORE
PRODUCTIVE TO SPEND OUR TIME
DISCUSSING SO OUR PLANNING TEAM
WILL GATHER ALL THE COMMENTS,
WILL WORK OFFLINE TO PREPARE A
SYNTHESIS FOR REVIEW INCLUDING
THE COLOR ASSIGNMENTS AND ASK
YOU GUYS TO REVIEW THAT OFFLINE
AFTER THE MEETING.
I'LL GOING TO GO AHEAD AND STOP
HERE AND SEE IF THERE'S ANY
QUESTIONS CHRISTINA AND I CAN
ANSWER BEFORE WE HEAD INTO
SESSION 1.
I MAY JUST REIT TATE WHILE WE'RE
WAITING TO SEE IF THERE'S
QUESTIONS BECAUSE WE'LL BE
SPENDING MORE TIME TODAY IN
DISCUSSION, MORE TIME TODAY
SUMMARIZING AND COLLATING YOUR
VIEWS AND COMMENTS PLEASE USE
THE MEETING CHAT LIBERALLY.
WE'LL DO OUR BEST TO CONSOLIDATE
AND SYNTHESIS AS WE GO THROUGH
THE MEETING.
I'M NOT SEEING ANY HANDS.
IF THERE ARE NONE I'M GOING TO
TURN OVER TO CHRISTINA TO
MODERATE SESSION 1.
>> WONDERFUL, THANKS SO MUCH,
SUE.
WE'RE PLEASED TO HAVE THE DAY AS
SUE MENTIONED COLLEAGUES FROM
THE INSTITUTES FROM CHILD HEALTH
AND HUMAN DEVELOPMENT.
THERE'S BEEN A NEUTRAL OF
ACTIVITIES GOING ON SINCE THE
RECOMMENDATIONS WERE PUT IN
PLACE AND WE'RE THRILLED TO HAVE
WITH US TODAY DR. NAHIDA
CHAKHTOURA AND AARON PAWLYK AND
CAMILLE FABIYI TALKING ABOUT
DEVELOPMENT.
ONE THING TO REITERATE IS PLEASE
USE THE CHAT FEATURE LIBERALLY
WE'RE DOWNLOADING THE COMMENTS
ONCE MADE AFTER THE MEETING AND
THEY'LL BE IMPORTANT FOR
INFORMING OUR REPORT.
WE ALSO HELPED GUIDE SOME
DISCUSSION THAT WILL TAKE PLACE
AFTERWARDS AND IF WE'RE
PROCEEDING WITH GOOD TIME WE'LL
BE ASKING NAHIDA AND AARON AND
CAMILLE IF THEY CAN ANSWER
CLARIFYING QUESTIONS ONCE
COMPLETED.
WITH THAT WE'LL JUMP IN AND I'D
LIKE TO BRING NAHIDA UP FOR THE
FIRST PRESENTATION FROM NICHD.
>> THANK YOU SO MUCH.
IT'S WONDERFUL TO BE WITH YOU.
I'M SORRY I MISSED THE FIRST
MEETING BUT I'M GLAD TO BE HERE
TODAY TO TALK ABOUT OUR CLINICAL
TRIAL NETWORKS WITHIN MY BRANCH
OF THE PREGNANCY AND PER
PERINATOLOGY BRANCH AND GLAD
MEMBERS OF THE VARIOUS NETWORKS
ARE PART OF THE COMMITTEE.
I WILL TALK ABOUT OUR THREE
NETWORKS, MFMU, NRU AND GN AND
ALL THREE HAVE BEEN AROUND THE
PAST COUPLE DECADES WITH THE
SAME STRUCTURE FOR THAT TIME
PERIOD AND UNTIL RECENTLY WHERE
THE STRUCTURE HAS CHANGED OR
BEEN MODIFIED A BIT NOT ONLY DID
WE INCREASE THE DURATION OF THE
NETWORK FROM FIVE YEARS TO SEVEN
YEARS BUT MODIFIED HOW THE
CLINICAL TRIAL PROCESS RUNS AND
SO WHAT HAS BEEN DONE AND THE
GOAL THE REASON WHY THE CHANGE
HAS OCCURRED IN THE SINCE 2020
IS TO REALLY TRY TO REACH THE
GOALS OR THE GUIDING PRINCIPLES
OF ENHANCING THE RIGOR AND
REPRODUCIBILITY OF CLINICAL
TRIALS, PROMOTING GREATER
AVAILABILITY OF MULTI-SITE
CLINICAL TRIAL INFRASTRUCTURE TO
A WIDE RANGE OF INVESTIGATORS
AND TRY TO FACILITATE DATA
SHARING AND ACCESS TO BIO
SPECIMENS TO EFFICIENTLY EXPAND
RESEARCH CAPACITY FOR ALL
INVESTIGATORS.
TO ALLOW FOR GREATER DIVERSE
POPULATIONS IN MULTI-SITE
CLINICAL TRIAL.
THE LAST YEAR THE NETWORKS WERE
RECOMPETED AND EACH OF THE
NETWORKS WERE RECOMPETED TO
AWARD AN INFRASTRUCTURE WITH A
DETE CENTER AND CLINICAL SITES
AND THE PROTOCOLS OR THE
CLINICAL TRIAL PROTOCOLS WOULD
BE SUBMITTED THROUGH A SEPARATE
GRANT APPLICATION PROCESS.
AND THIS FUNDING OPPORTUNITY WAS
RELEASED IN NOVEMBER OF 2022.
SO ANY QUALIFIED INVESTIGATOR
CAN SUBMIT TO THE PROPOSED
CLINICAL TRIAL.
SO THAT'S ONE OF THE WAYS THAT
THIS WAS MODIFIED FOR THIS
UPCOMING CYCLE AGAIN FROM 2023
TO 2030 THE NETWORK DURATION FOR
THE NEW THREE CLINICAL TRIALS
WITHIN THE NETWORK.
SO I'LL START WITH THE MATERNAL
FETAL MEDICINE UNIT NETWORK.
AGAIN, THE PURPOSE OF THE
NETWORK IS TO REDUCE MATERNAL
FETAL AND INFANT MORTALITY AND
MORE BIT AND MATERNAL
COMPLICATIONS, EXPAND THE
EVIDENCE BASE ABOUT THE SAFETY
AND EFFICACY OF THERAPEUTIC
TREATMENTS USED DURING PREGNANCY
AND LACTATION AND REALLY THE
OBJECTIVE IS TO CONDUCT
DEFINITIVE RIGOROUS AND
REPRODUCIBLE MULTI-SITE CLINICAL
TRIALS AND OBSERVATIONAL STUDIES
IN PREGNANT AND LACTATING PEOPLE
PROVIDING EVIDENCE TO CLINICAL
PRACTICE.
THE CURRENT CLINICAL SITES ARE
GEOGRAPHICALLY DIVERSE ACROSS
THE COUNTRY.
WE HAVE 14 CLINICAL SITES THAT
ENCOMPASSES 27 RECRUITING SITES
WITHIN THOSE AREAS AND AS YOU
CAN NOTE HERE THE TRIALS
COMPLETED WITHIN THE NETWORK
HAVE A HIGH IMPACT ON PRACTICE
WITH OVER 25% OF THE PAPER CITED
IN MEDICAL GUIDELINES.
THESE HAVE BEEN PRODUCTIVE FOR
THE OBSTETRIC COMMUNITY.
ONE OF THE TRIALS COMPLETED AND
I'M NOW GOING TO GO THROUGH THE
YEARS MUCH TRIALS COMPLETED
WITHIN THE NETWORKS TO HIGHLIGHT
SOME EXAMPLES OF WHAT WAS DONE.
ONE IS TRANEXAMIC ACID TO
PREVENT OBSTETRICAL HEMORRHAGE
AFTER CAESAREAN DELIVERY AND
THINKING THERE IT REDUCED THE
BLOOD LOSS AND THERE WAS A
QUESTION IF THE AFFECT IF THAT
REDUCTION REDUCED THE NUMBER OF
BLOOD TRANSFUSIONS OR AFFECTED
SECONDARY OUTCOMES SUCH AS BLOOD
LOSS MORE THAN A LITER
INVENTIONS FROM BLEEDING AND
FURTHER COMPLICATIONS AN
PRE-OPERATIVE OR POST-OPERATIVE
CHANGES TO HEMOGLOBIN AND
COMPLICATIONS AND THERE WAS A
DIFFERENT FROM THE PLACEBO ARM
AND WE NEED OBSTETRICS AND IN
THE POSTPARTUM PERIOD TO PROVIDE
THE EVIDENCE TO CHANGE THE
CLINICAL PRACTICE.
ANOTHER STUDY OF HOW THE
CLINICAL NETWORK STUDIES WERE
LEVERAGED BY OTHER INSTITUTIONS
SUCH AS NHLBI, THE NEW MOMS TO
BE STUDY WHICH RECRUITED
PRIMARILY BY NICHD AND RECRUITED
WOMEN OR INDIVIDUALS WHO HAD
FIRST-PREGNANCIES AND FOLLOWED
THEM PROSPECTIVELY AND THAT
STU
STUDIED BY NHLBI AND LOOKING AT
THE LONG TERM OUTCOMES THAT
DEVELOP AFTER PREGNANCIES AND
ADVERSE OUTCOMES AND A SUBGROUP
OF INDIVIDUALS WITH ANOTHER
GROUP FOLLOWED LOOKING AT
INDIVIDUALS WITH OBSTETRIC SLEEP
APNEA.
NOT ONLY DO THE PRIMARY STUDIES
IMPORTANT TO CLINICAL PRACTICE
BUT ANY SECONDARY STUDIES AS
WELL DONE BASED ON ANY OF THE
CLINICAL TRIALS SO THIS IS AN
EXAMPLE OF THAT AND THEN
HIGHLIGHTING THE NEXT NETWORK
WHICH IS THE GLOBAL NETWORK FOR
WOMEN AND CHILDREN'S HEALTH
RESEARCH TO IMPROVE MATERNAL AND
CHILD SURVIVAL FOCUSSED ON HIGH
NEED AREAS SUCH AS PREVENTING
LIFE-SAVING OBSTETRICAL
INTERVENTIONS FOR PRACTICES AND
IMPROVING BIRTH WEIGHT AND
NUTRITION AND PREVENTING
COMPLICATIONS FROM RURAL AND
PERIURBAN COMMUNITIES GLOBALLY.
THE STRUCTURE FOR THE GLOBAL
NETWORK IS A LITTLE BIT
DIFFERENT THAN THE U.S.-BASED OR
DOMESTIC NETWORKS IN THAT THE
TEAMS WORK TOGETHER WITH
U.S. PARTNERS AND THEY WORK WITH
PEERS AND THE LEAD TEAMS ADDRESS
THE PRIORITIES AND NEEDS OF THE
RESEARCH AREAS IN THE LOW
RESOURCE CENTERS STO FOR
EXAMPLE -- SO FOR FOR EXAMPLE
THE UNIVERSITY OF CAROLINA, CHAP
HEL HILL PARTNERS WITH THE
DEMOCRATIC REPUBLIC OF CONGO TO
DO STUDIES WITHIN THE MATERNAL
NETWORKS AND THE FETAL NETWORK
IN THE SENSE THE NEW STRUCTURE
IS THE SAME AND LOOK AT FUTURE
FOR CLINICAL TRIALS IN THE
NETWORK AND SOME ACTIVITIES AND
THESE ARE SOME OF THE LOCATIONS.
HERE WE HAVE LOCATIONS WITHIN
AFRICA AND ASIA AND THEN THE
U.S. PARTNERS ACROSS THE STATES.
HERE WE HAVE THE PRIVATE PUBLIC
PARTNERSHIPS THROUGH THE
FOUNDATION OF NIH THAT SUPPORTS
THESE TRIALS IN THE GLOBAL
SETTING THE A-PLUS STUDY WAS
SUPPORT THE BILL AND MELINDA
GATES FOUNDATION AND TESTED
WHETHER A SINGLE ORAL 2 GRAM
DOSE OF ANTIBIOTIC OF
AZITHROMYCIN MAY HELP PREVENT
MATERNAL DEATH AND IT WAS ABLE
TO PREVENT SEPSIS AND DEATH BY
ONE-THIRD IN THE STUDY.
IT DID NOT REDUCE STILLBIRTH OR
NEONATAL DEATHS IN THE STUDY.
IT WAS STUDIED FOR EFFICACY ON
THE MATERNAL BENEFIT.
THE SECOND TRIAL IS TO ENROLL
4800 INDIVIDUALS WHO ARE
PREGNANT IN INDIVIDUALS LOOKING
AT INFUSION AT THE TIME OF
DELIVER DLY LOOKING AT ANEMIA A
SIX WEEKS.
MANY STUDIES ARE IN DASH AND THE
NEW MOMS TO BE STUDY IS AN
EXAMPLE AND YOU'LL HEAR MORE HOW
THAT STUDY IS GOING TO BE
LEVERAGED THROUGH THE FNIH.
THIS ENDS MY PRESENTATION.
I'M HAPPY TO TAKE ANY CLARIFYING
QUESTIONS NOW OR LATER BUT THANK
YOU FOR YOUR TIME AND I LOOK
FORWARD TO PARTICIPATING IN THE
DISCUSSIONS.
I THINK WE HAVE TIME FOR
CLARIFYING QUESTIONS IF THERE'S
ONE FROM THE WORKING GROUP.
>> I HAVE A QUESTION, I'M SORRY.
I'M WITH THE AMERICAN COLLEGE OF
OBSTETRICIANS AND GYNECOLOGISS
THIS IS EXCELLENT AND WE'RE BIG
FANS OF THE NETWORKS AND THE
WORK YOU ALL DO.
I'M WONDERING SPECIFICALLY WITH
THE FMNU IF YOU'RE ABLE TO SHARE
WORK THEY'RE DOING SPECIFIC TO
THERAPEUTICS.
I THINK THERE HAS BEEN SOME WORK
THEY'VE DONE AND IT WOULD BE
GREAT TO GET A SENSE OF THAT AND
ANYTHING YOU'D WANT US TO TAKE
AWAY FROM THE CONVERSATION FROM
THAT SPECIFICALLY.
>> SURE.
I'M HAPPY TO PROVIDE --
>> NAHIDA, THIS IS ALLISON AND I
WANTED TO TAG ON TO RACHEL'S
QUESTIONS AND ASK ABOUT
CONVENTIONAL TAGS.
>> I'M HAPPY TO PROVIDE A LIST
OF THERAPEUTIC TRIALS DONE
THROUGH THE NOETWORK.
THERE'S SEVERAL TRIALS AND I'M
HAPPY TO PROVIDE A LIST AND
SHARE THAT WITH THE WORKING
GROUP.
ONE EXAMPLE WAS THE ACID STUDY
AND I THINK THERE ARE SEVERAL
WITHIN BOTH NETWORKS AND HAPPY
TO PROVIDE A LIST OF ALL THE
THERAPEUTIC TRIALS THAT HAVE
BEEN DONE THROUGH THE NETWORK.
YOU CAN ANSWER QUESTIONS WITHIN
THE CHAT OR POST MEETING AND
WE'LL PROVIDE IT TO THE WORK
GROUP MEMBERS.
THANK YOU.
I SEE A QUESTION.
>> IT'S SOMEWHAT MORE DRILLED
DOWN GIVEN THE FACT THAT WE'RE
CHARGED WITH EVALUATING THE
IMPACT AND IMPLEMENTATION PRGLAC
RECOMMENDATIONS AND MY QUESTION
IS WHAT HAS CHANGED AND HOW HAVE
THESE NETWORKS INCORPORATED THE
RECOMMENDATIONS OF PRGLAC.
HOW WOULD THIS PRESENTATION
LOOKED DIFFERENT PRE-PRGLAC.
>> GREAT QUESTION.
THE MATERNAL MEDICINE NETWORK
HAVE BEEN DEDICATED TO IMPROVING
MATERNAL HEALTH PREPRGLAC AND
WE'VE BEEN AT THE FOR FRONT OF
TRYING TO ANSWER THESE QUESTION
FOR OUR PATIENT POPULATION.
I THINK THAT AND THERE'S BEEN
ROAD BLOCKS.
WE CAN HAVE EXAMPLES OF ROAD
BLOCKS OF GETTING TRIALS DONE
THROUGH THE NETWORKS FOR VARIOUS
REASONS SO WE DO THAT.
WE DO HAVE THAT BUT I THINK IN
GENERAL THE HOPE IS TO CONTINUE
AND WHAT WE'RE HOPING TO DO IS
TRY WITH THE NEW STRUCTURE TO
ADVOCATE FOR MORE CROSS-NETWORK
COLLABORATIONS AND HAVING THE
BIO SPECIMENS SHARED TO GET MORE
INFORMATION FROM THE CLINICAL
TRIAL WE HAVE.
THAT'S PART OF THE REASON WHY
THE WORK DR. POLLACK WILL BE
DISCUSSING AND THE WORK THROUGH
THE FNIH AROUND BIOMARKERS FOR
PREECLAMPSIA BUT LEVERAGING THE
BIO SPECIMENS THROUGH THE
NETWORK AND HAVE BEEN AT THE
FOREFRONT OF DOING WORK IN THIS
POPULATION PREDATING THAT.
>> THANK YOU.
I THINK WE CAN REVISIT THIS
AFTER DR. PAWLYK HAS PRESENTED I
THINK WE'LL HEAR MORE ON THE
WORK AND USE OF DASH.
YOU CAN PUT THE QUESTION IN THE
CHAT AND WE'LL BE SURE TO RETURN
TO BE SURE TO MOVE ON FOR THE
NEXT PRESENTATION FROM
DR. PAWLYK.
>> THANK YOU.
>> I'D LIKE TO INTRODUCE
DR. PAWLYK.
I WANT TO MAKE SURE EVERYONE CAN
HEAR YOU.
>> CAN PEOPLE HEAR ME?
>> PERFECT, THANK YOU SO MUCH.
>> THANK YOU ALL.
I'LL ALSO ADD AS WELL AS MY
PRESENTATION WILL BE GOOD TO
COME BACK TO SOME OF THESE
QUESTIONS AFTER ALL THREE
PRESENTATIONS WHEN DR. FABIYI
PRESENTS ON THE PROCESS WE'RE
UNDERGOING.
THAT CAN INFORM FUTURE
DIRECTIONS.
WE'RE THINKING HOW TO CATALYZE
INNOVATION IN MATERNAL
THERAPEUTICS AND I OFTEN USE
MATERNAL THERAPEUTICS WHEN
REFERRING TO PREGNANCY AND
LACTATION.
WE HAVE A NEW NOVEL NETWORK AND
HAPPY TO SEE SOME INVESTIGATORS
INVOLVED IN THAT ARE ON THE CALL
AS WELL AS WHAT WE'RE DOING AND
POTENTIALLY WHAT WE COULD DO IN
THE FUTURE TO GET TO NOVEL
OBSTETRIC CONDITIONS.
THE NETWORK I WANT TO TALK ABOUT
I WANT TO TALK ABOUT IN
DIFFERENT CONTEXT IS THE MPRINT
HUB WE STARTED TWO AND A HALF
YEARS AGO IS WHEN THE AWARDS
CAME OUT.
THIS IS A NEW IN THE CENTER THIS
IS THE IMPRINT HUB OF THREE
CORES AND CENTERS I'LL DESCRIBE
IN MORE DETAIL AFTERWARDS.
WE WANTED TO WORK WITH DASH TO
START TO DO THIS TO PROVIDE
KNOWLEDGE AND EXPERTISE TO
ENABLE MORE INVESTIGATORS TO
CONDUCT MATERNAL PHARMACOLOGY
AND THERAPEUTICS TRIALS.
WE HAVE FIELD FOR PRECISION
MEDICINE AND BETTER DOSING
WITHIN THE POPULATIONS AND
SYNERGIZE AND PROVIDE THE HUB
CHARGED WITH DOING THAT AS WELL
AS THINGS IN THE PEDIATRIC
NETWORK AND I WANT TO EMPHASIZE
THE MAIN GOALS OF THE CENTERS.
THE FIRST CENTER IS A KRCC AN
AWARD TO INDIANA UNIVERSITY AND
OHIO STATE UNIVERSITY.
THE FIRST COMPONENT IS A
KNOWLEDGE-BASED AND PORTAL CORE
CHARGED WITH INDEXING ALL THE
PUBLICLY AVAILABLE INFORMATION
THAT WE CAN FIND AROUND MATERNAL
AND PEDIATRIC THERAPEUTICS AND I
SHOULD MENTION THIS IS A DUAL
PROJECT SUPPORTED THE BEST
PHARMACEUTICALS FOR CHILDREN ACT
AS WELL AS FUNDS THE NICHD
ALLOCATED TO FOLLOW-UP ON THE
PRGLAC IMPLEMENTATION.
THE KNOWLEDGE BASE AND PORTAL
CORE STARTS UP WITH THIS INTO A
BROADER FRAMEWORK THAT CAN THEN
BE MAPPED TO POSSIBLE ELECTRONIC
HEALTH RECORDS DATA, PHENOTYPE
DATA, DRUG ONTOLOGIES AND GET TO
CATALYZING SO WE KNOW WHAT WE'VE
DONE WE KNOW WHAT WE HAVEN'T
DONE AND THERE'S A REAL-WORLD
EVIDENCE CORE CHARGED USING NEW
APPROACHES AND MOTHER-BABY
LINKAGES FOR COMBINING HEALTH
REPORT DATA AND VARIETY OF DATA
AND PROVIDING A DATA MARK USED
TO CHARACTERIZE MATERNAL AND
PETE -- PEDIATRIC DRAWS AND WHEN
WE TALK ABOUT KNOWLEDGE IT'S
IMPORTANT TO POINT A POINT ON
THAT AND NOT JUST GENERATING
KNOWLEDGE FOR KNOWLEDGE BUT
ANOTHER CORE TAKING THE
KNOWLEDGE AND PUTTING IT INTO
PHARMACO METRIC MODELS AND THESE
ARE PHYSIOLOGIC PHARMACO GENETIC
MODELS WHICH ARE COMPLICATED AND
LOOK AT CHANGES WITH PREGNANCY
AND LACTATION.
THE GOAL IS TO ENABLE MODEL
INFORMED DRUG DEVELOPMENT AND
CLINICAL TRIAL DESIGN TO DO
BETTER DESIGN STUDIES WE THINK
HAVE THE MOST LIKELIHOOD TO
DEMONSTRATE EFFICACY AND BE
SAFE.
S THERE'S OUTREACH AND
DISSEMINATION AND INTERFACE WITH
NETWORKS THAT'S QUITE A
SUBSTANTIAL EFFORT REQUIRED.
THE FIRST CENTER OF EXCELLENCE
AND THERAPEUTICS I'LL DESCRIBE
IS AT THE VANDERBILT UNIVERSITY
LEVERAGING A LOT OF THEIR
EXTENSIVE BIO VIEW AND BIO BANK
DATA.
THE CORE THAT DRIVES ALL THE
PROJECTS THAT ARE UNDERTAKEN
WITHIN THIS PARTICULAR CENTER.
PROJECT 1 FOCUSES ON GENERATING
PHARMACO GENOMICS AND GET
INFORMATION ON THAT IN MATERNAL
AND PEDIATRIC POPULATION.
PROJECT 2 FOCUSES ON MATERNAL
AND NEONATAL OUTCOMES OF
MATERNAL OPIOID USE AND THERE'S
A PRECISION THERAPEUTIC ACADEMY
WHICH SERVES THE ROLE OF
PROVIDING EDUCATION, TEACHING
AND TRAINING LINKED WITH OUR
TRAINING ACTIVITIES ACROSS
NICHD.
THE SECOND CENTER FOR EXCELLENCE
IS AT U.C. SAN DIEGO FOCUSSED ON
ANTIBIOTIC USE AND MOTHERS AN
INFANTS USING A VARIETY OF
APPROACHES THROUGH
COLLABORATIONS SUCH AS WITH THE
PEDIATRIC TRIALS NETWORK.
WE'RE EXTENDING TO ADDITIONAL
DRUG CLASSES SUCH AS
ANTI-DEPRESSANTS.
THIS IS PRIMARILY A MAJOR
PROJECT THE CLINICAL PROJECT
LOOKING AT THE PHARMACO KINETICS
OF ANTIBODIES AND HUMAN MILK AS
WELL AS THE COMPOSITION OF MILK
AND HOW THAT'S ALTERED BY
ANTIBIOTIC INTAKE.
THERE'S A LARGE DATA SCIENCE
PROJECT FOCUSSING ON
METABOLIZING THE METABOLOME IN
HUMAN MILK AS WELL AS INFANTS
LOOKING AT MICROBIOME AND HUMAN
MILK COMPOSITION AND PULLING
THAT TOGETHER.
ANOTHER LARGE PROJECT IS
FOCUSSED ON BASIC SCIENCE MODELS
OF THE EFFECTS WE'RE SEEING IN
TERMS OF DRUG EFFECTS IN ANIMAL
MODELS SO ADDITIONAL WORK THAT
CAN BE DONE YOU JUST CAN'T DO IN
HUMAN POPULATIONS.
AND ALL THIS IS ENABLED BY
ANALYTICAL AND CHEMISTRY CORES
THAT PROVIDE THE ANALYSIS.
I HAVE ALSO MENTIONED HERE
RECENTLY U.C. SAN DIEGO HAS
CREATED WHAT THEY CALL THE HUMAN
MILK INSTITUTE.
I'M NOT GOING TO GO THROUGH ALL
THESE EFFORTS BUT GIVEN THE
CONVERGENCE OF THESE ACTIVITIES
AT U.C. SAN DIEGO THEY OPTED TO
CREATE THE HUMAN MILK INSTITUTE
AND THIS HIGHLIGHTS THE
IMPORTANCE OF HAVING PUB -- HUB
LIKE ACTIVITIES TO BRING
TOGETHER THE ACTIVITIES BEING
SUPPORT OTHER GROUPS.
I WANT TO INTRODUCE THE ONLINE
PERINATAL AND PEDIATRIC
REPOSITORY CHARGED WITH CON
DUCKING LANDSCAPE ASSESSMENT OF
BIO BANKS.
ALL RELATES TO OBSTETRIC
CONDITIONS THAT NAHIDA INDICATED
WERE IN DASH AS WELL AS PRIVATE
COLLECTIONS AND THIS IS QUITE AN
UNDERTAKING TO PULL TOGETHER
WHERE WE ARE WITH EXISTING BIO
SAMPLES AND HOW THESE CAN BE
USED AND INTEGRATED TO SUPPORT
LONG TERM STUDIES AND OUTCOME.
WITH BARDA WE INITIATED A
VACCINE AND MEDICATION STUDY AND
PREGNANCY SURVEILLANCE SYSTEM.
WE'RE LOOKING AT THE PREGNANCY
OUTCOMES FOR MOM AND BABY
VACCINATED OR NOT AND WERE
PLEASED SUPPORT THE STUDY TOE
DEAL WITH EMERGING PANDEMIC.
THE LAST THING I WANT TO
HIGHLIGHT AT THE MPRINT HUB IS
FUNDING OPPORTUNITIES.
THERE'S SOME CURRENTLY AND WE
CANT SEND THOSE AROUND.
THERE'S OPPORTUNITY POOLS AND
EACH HAVE ADDITIONAL FUNDING
POOLS.
THESE ARE ELIGIBLE TO ANYBODY
THAT CAN COME IN AND BE
SUCCESSFUL WITH THOSE.
YOU CAN SEND E-MAIL TO THE
MPRINT HUB FOR MORE INFORMATION.
AFTER THREE YEARS OF THIS
THERE'S BEEN SUCCESS HERE.
QUITE A NUMBER OF AWARDS HAVE
GONE OUT TO CLINICAL FELLOWS AND
POSTDOC.
THE FACULTY AWARDS HAVE GONE TO
MORE JUNIOR FACULTY AND HERE'S A
GOOD SPLIT IN TERMS OF PEDIATRIC
AND PREGNANCY AND LACTATION.
THIS IMAGE HERE SHOWS WHERE THE
FUNDING HAS GONE.
IT'S GOING OUTSIDE THE MPRINT
HUB AND ENABLING JUNIOR FACULTY
AND POSTDOCS AND FELLOWS TO
EXPLORE NEW THINGS IN MATERNAL
PEDIATRICS.
NOW I'LL TALK ABOUT NOVEL
THERAPEUTICS FOR LACTATION
SPECIFIC CONDITIONS AND WHAT
WE'RE DOING AND PERHAPS THINKING
MORE WHAT WE COULD DO.
I'M GOING TO TALK ABOUT
OBSTETRIC CONDITIONS AS AN
EXAMPLE.
I THINK EVERYTHING I'M
DESCRIBING COULD BE APPLIED TO
LACTATION SPECIFIC CONDITIONS.
WE DON'T HAVE AS MUCH AS GOING
ON IN TERMS OF NOVEL DRUGS AND
DISCOVERY FOR THESE CONDITIONS
BUT THE FRAMEWORK CAN APPLY.
I THINK OF THIS AS A
THREE-LEGGED STOOL HAVING
BIOMARKERS FOR PATIENT
STRATIFICATION, SURROGATE
OUTCOMES, DRUG TARGET ENGAGEMENT
ETCETERA.
FOR THE POPULATIONS WE'RE
TALKING ABOUT WE NEED IMPROVED
NON-CLINICAL SAFETY ASSESSMENT
MODELS AND GETTING TO HUMAN DRUG
TARGET VALIDATION IS VERY
IMPORTANT EARLY ON SO WE CAN
KNOW WHICH THERAPEUTIC TO WORK
ON AND FOCUS ON.
NAHIDA MENTIONED THE FOUNDATION
FOR THE NICHD EARLIER BUT WANT
TO MAKE SURE WE REINTRODUCE
THIS.
IT'S A NON-PROFIT ORGANIZATION
CHARTED BY CONGRESS IN 1996 TO
SUPPORT THE MISSION OF THE NIH.
IT'S AN INDEPENDENT NON PROFIT
AND CAN CREATE VARIOUS
PARTNERSHIPS THE NIH CANNOT DO
AS FEDERAL AGENCY AND IT'S
BUILDING BRIDGES TO BREAKTHROUGH
BECAUSE IT TAKES A LOT OF
ORGANIZATION TO DO THIS.
ONE OF THE COMPONENTS OF THE
FOUNDATION FOR THE NIH IS THE
BIOMEDICAL CONSORTIUM.
A GOOD NUMBER OF PROJECTS THAT
HAVE MOVED FORWARD AND FUNDING
FROM MOSTLY PHARMACEUTICAL
INDUSTRY AND DIAGNOSTIC
COMPANIES TO PURSUE THESE.
THE FDA'S INVOLVED IN THIS AND
THERE'S EXPERTISE IN HOW TO GET
BIOMEDICAL QUALIFICATION FROM
THE FDA.
THIS PROJECT IS LAUNCHING SOON
BUT I WAS HAPPY THERE'S A
RETROSPECTIVE STUDY LEVERAGE IN
THE BIO BANKS AND ADDITIONAL
ONES IDENTIFIED.
COMMERCIAL KITS BEING
CONTRIBUTED BY DIAGNOSTIC
COMPANIES.
THEY'RE USED OUTSIDE THE UNITED
STATES THEY'RE NOT AVAILABLE
COMMERCIALLY AS WIDELY IN THE
UNITED STATES.
THEY CAN BE USED IN ACADEMIC
LABS BUT WE WANT TO MAKE THESE
MORE AVAILABLE TO BE USED FOR
SCREENING IN ANY PREGNANT
PERSON.
THE GOAL STO GENERATE DATA THAT
CAN BE USED FOR REGULATORY
FILING BUT WITH THE FDA IN TERMS
OF QUALIFIED BIOMARKERS FOR USE
IN FUTURE DRUG DEVELOPMENT
STUDIED AND CLINICAL TREATMENT
AND HIGH-RISK PATIENT.
WE HAVE MEMBERS FROM THE FDA
INVOLVED TO GET EARLY INPUT ON
THIS IS AN VALUABLE CALCULATOR
TO BE USED FROM THE FETAL
MEDICINE FOUNDATION.
THE BIOMARKERS DO NOT HAVE EARLY
RISK PREDICTION OF PREECLAMPSIA
AND AGAIN IN GETTING FDA
QUALIFICATION WILL ENABLE THE
TOOL TO BE MORE BROADLY UTILIZED
WITHIN THE UNITED STATES.
THIS WILL LAUNCH FEBRUARY SOth
AT THE SOCIETY FOR FETAL
MEDICINE CONFERENCE THERE WILL
BE AN ENVIRONMENT OPTION AND
IT'S A SMALL ROOM SO PLEASE
SHOOT ME AN E-MAIL AND I CAN GET
YOU INVITED.
WE ALSO WANT TO BE FORWARD
THINKING.
ONE COMPONENT WE'RE ABLE TO ADD
TO THE MPRINT HUB IS A BIOMARKER
PLATFORM FOR PLACENTAL OR FETAL
EXOSOMES.
THESE ARE SMALL SPHERES SECRETED
FROM CELLS AND THEY ARE ACTUALLY
REALLY GOOD REPRESENTS OF
PHYSIOLOGICAL STATUS OF THE
ORIGIN CELL.
IN A PREGNANT PERSON'S BLOOD
ROUGHLY 25 TO 30% ARE FROM THE
PLACENTA IN THE THIRD TRIMESTER.
THIS IS A GREAT SOURCE FOR
POTENTIAL BIOMARKERS.
YOU CAN SEE THE TWO GRAPHS ARE
DIFFERENT.
ONE THE PROTEOME YOU LOOK AT ONE
COMPONENT IN NORMAL PREGNANCY IS
DIFFERENT FROM PRE-TERM
PREGNANCY.
THERE'S POTENTIAL NOR
BIOMARKERS.
WE'RE EXCITED TO BE MOVING
FORWARD WITH THAT.
WE'RE HAVING A WORKSHOP COMING
UP TAKING A LOT OF THE BIO
SAMPLES AND DATA AND PUTTING
INTO A KNOWLEDGE RESOURCE AND
DATABASE AND THINKING HOW IT
COULD POTENTIALLY INTERFACE WITH
THE MPRINT KNOWLEDGE BASE DOWN
THE ROAD AS WELL AS ONE I'LL
TALK ABOUT IN A LITTLE BIT.
IT'S CO-ORGANIZED BY NICHD AND
AND OPPTB AND THE FOUNDATION FOR
THE NIH WE'LL BE BRINGING IN
COHORT OWNERS, DIAGNOSTIC
SCIENTISTS AND COMPANIES AND
GETTING TO THE GOAL OF
ADDITIONAL TYPES OF BIOMARKERS
AND HOW TO USE THAT MORE
EFFECTIVELY.
THE WORK SLB IN BETHESDA AND THE
PREJ ADMINISTRATION SITE WILL
COME SOON AND WE'LL DISTRIBUTE
THAT ONCE AVAILABLE IF YOU'D
LIKE TO ATTEND.
THE SECOND LEG OF THE STOOL AND
WE NEW MODELS TO EVALUATE
EFFICACY AND THIS NOT ALL THE
PROJECTS NICHD IS FUNDING BUT
THE FIRST IS USING
MICROPHYSIOLOGICAL SYSTEMS TO
GENERATE MATERNAL-FETAL
INTERFACE ON CHIPS.
THERE'S CONSTRUCTS WITH
DIFFERENT CHAMBERS ON DIFFERENT
CELL TYPES IN THEM.
YOU CAN RUN A FETAL-BLOOD
SURROGATE THROUGH ONE SIDE AND
MATERNAL BLOOD SURROGATE FROM
ANOTHER SIDE AND SEE WHAT'S
MOVING ACROSS THE MEMBRANES.
THAT'S WHAT THEY'RE WORKING TO
DEVELOP AND THIS IS ACTUALLY A
PROJECT WE CO-FUND WITH NCATS
PART OF A LARGER PROGRAM THEY
HAVE.
ANOTHER ONE WE FUND AS A SMALL
BUSINESS BRANCH I'M EXCITED
ABOUT IS BUILDING AN INTERESTING
IN VITRO APPROACH AND
COMPUTATIONAL MODELS FOR THE
PLACENTAL BARRIER TO PREDICT
FETAL EXPOSURE AND TOXICITY.
THERE'S IF YOU WANT THESE CHIPS
TO BE AVAILABLE TO BE USED BY
THE PHARMACEUTICAL INDUSTRY OR
ACADEMIC INVESTIGATORS AND ANY
ADDITIONAL PRODUCT IS THE
ORGANOIDS USED ASSESS
THERAPEUTIC RESPONSE.
THEY FOCUS MORE ON SAFETY
ASSESSMENTS.
LAST
LASTLY THERE'S A PROGRAM COMMON
FUND COMPLEMENT-ARIE PROGRAM AND
TO LOOK AT NEW WAYS TO DO
PRE-CLINICAL TYPES OF STUDIES.
NICHD IS EVALUATED ON THE WORK
GROUP.
THIS PROGRAM HAS LOOK AT
REGULATORY POOLS AVAILABLE AND
WANT TO MAKE SURE PREGNANCY AND
LACTATION ARE INCLUDED.
THIS WILL BE PRESENTED AT THE
COUNCIL'S COUNCIL NEXT WEEK AND
GET INPUT AND SEE WHERE IT GOES
FROM THERE.
LASTLY, I WANT TO TALK ABOUT
DRUG TARGET VALIDATION.
I WANTED TO TALK ABOUT OUR
PROGRAMS SEEN AS THE AMERICA'S
SEED FUND TO TRANSLATE IDEAS
INTO LACKS OF LABLTHS -- INTO
INTO LARGER COMPANIES AND
LOOKING AT PRE-TERM BIRTH AND A
THERAPEUTIC FOR HYPERMESIS AND
LOOKING AT PREECLAMPSIA AND
LOOKING MORE BROADLY AND I WANT
TO BRING UP THE FOUNDATION FOR
THE ACCELERATING MEDICINE
PARTNERSHIP PROGRAM STARTED IN
2014 WITH THE IDEA OF UNITING
RESOURCES TO UNDERSTAND DISEASE
PATHWAYS AND GET TO NEW TARGETS
AND BIOMARKERS.
THERE'S BEEN A VARIETY OF
PROGRAMS AND TO SUM THIS UP IT'S
A PYRAMID WHERE WE HAVE
REPOSITORIES AND DATA AND FUELS
AND ALGORITHMS THROUGH OTHER
PROJECTS AND KNOWLEDGE PORTALS
TO ACCESS THEM AND IDENTIFY
POTENTIAL DRUG TARGETS AND
BIOMARKERS.
ONE IS THE HUGE AMP USING HUMAN
GENETICS AS THE FOUNDATION FOR
THIS GETTING TO THE HUMAN-BASED
DRUG TARGET VALIDATION.
THEY WERE ABLE TO GET A
REPRODUCTIVE SYSTEM PORTAL
BRINGING IN DATA AND GET TO
EFFECTER GENES THAT MAY SERVE AS
DRUG TARGETS, BIOMARKERS OR
DISEASE INSIGHTS.
I'M HAPPY TO TAKE ANY QUESTIONS
NOW OR AFTER THE NEXT TALK.
THANK YOU ALL.
>> THANK YOU FOR TAKING US ON
THE WHIRLWIND PIECES OF WHAT IS
BEING DONE THROUGH YOUR BRANCH.
I WANTED TO LEAVE ROOM FOR ONE
CLARIFICATION QUESTION TO GET
TON -- ON TO CAMILLE'S
PRESENTATION AND THERE'S A
QUESTION IN THE CHAT BUT MORE
SUITED TO THE DISCUSSION SO
ANYTHING NOR AARON RIGHT NOW?
HEARING NOTHING AND GOING TO YOU
CAMILLE AND WANT TO MAKE SURE
EVERYONE CAN HEAR YOU CLEARLY.
CAN YOU SEE AND HEAR ME?
>> PERFECTLY.
>> GOOD AFTERNOON.
I'M A PROGRAM OFFICER WITHIN THE
OBSTETRIC AND PEDIATRIC BRANCH
AND PLEASED TO TALK ABOUT THE
DRUG, VACCINE AND DIETARY
SUPPLEMENT RESEARCH NEEDS FOR
PREGNANT, POSTPARTUM AND
LACTATING PERSONS.
SO THIS RECOMMENDATION 8B AND 9A
OF THE IMPLEMENTATION PLAN
CALLED FOR THE DEVELOPMENT AND
CREATION OF SEPARATE PROCESSES
FOR THERAPIES AND CONDITIONS IN
LACTATING WOMEN AND THE GUIDANCE
ALSO RECOMMENDED USING NIH'S
BCCA OR BEST PHARMACEUTICALS
FOR CHILDREN ACT AS A MODEL.
THE STEPS OUTLINE D AND THE PLA
HAVE REQUEST FOR INFORMATION
ABOUT DESCRIBING NICHD HAD
NOMINATIONS FOR DRUG AND
VACCINES AND NEEDS TO BE
CONSIDERED IN THE DEVELOPMENT OF
A PRIORITY LIST ON DRUGS,
VACCINES AND DIETARY RESEARCH
NEEDS FOR PREGNANT AND
POSTPARTUM PERSONS PUBLISHED ON
MAY 8.
WE WERE SEEING THEM THROUGH THE
END OF SEPTEMBER PUBLISHED IN
THE NIH GUIDE AND FEDERAL
REGISTER AND THE LINK ARE SHOWN
ON TO THE SLIDE BELOW.
WE WERE HAPPY TO PROVIDE THE
NOMINATIONS AND PROVIDE AN
OVERVIEW OF THE RISKS.
THIS SHOWS THE NUMBER OF
NOMINATION BY NOMINATION TYPE ON
THE LEFT AND MOST THE
NOMINATIONS WERE FOR DRUGS OF
THE 136, 114 FOR DRUGS AND TWO
NOMINATIONS FOR VACCINES MOST
NOMINATIONS RECEIVED WERE FOR
GENERAL MEDICAL CONDITIONS SO
THAT'S PRIMARILY CONSISTED OF
PREEXISTING MEDICAL CONDITIONS
OF THE NOMINATIONS, 79 WERE FOR
GENERAL MEDICAL CONDITIONS
FOLLOWED BY 35 FOR PREGNANCY OR
POSTPARTUM AND 22 FOR LACTATION
SPECIFIC CONDITIONS.
THE TOP 10 THERAPEUTIC AREAS
INCLUDED MENTAL HEALTH RELATED
CONDITIONS AND INFECTIOUS
DISEASES AND PRETERM BIRTH,
ASTHMA AND CARDIOVASCULAR
DISEASE TO ROUND OFF THE TOP
FIVE FOLLOWED BY HYPERTENSIVE
DISORDERS.
FILL BEING SUPPLY ISSUES AND
SLEEP CIRCADIAN DISORDERS AND
DIABETES AND OBESITY.
AND EARLY IN OUR PROCESS IN THE
FALL WE TOOK THE TIME AFTER THE
PUBLIC COMMENT PERIOD WE EXPIRED
WE COLLATE THE NOMINATIONS WE'RE
BEGINNING AN INTERNAL REVIEW OF
NOMINATIONS WITH OUR COLLEAGUES
AROUND NIH WITH THAT WILL TAKE
US INTO THE END OF NEXT MONTH
AND LATER THIS YEAR WE PLAN TO
CONVENE AN EXTERNAL STAKEHOLDER
MEETING TO DISCUSS THE INITIAL
NOMINATION LIST AND GOING INTO
EARLY NEXT YEAR WE PLAN ON
GATHERING INPUT FROM
STAKEHOLDERS ON THE PRELIMINARY
LIST OF VACCINE AND RESEARCH
TEAMS AND MID TO LATE PART OF
NEXT YEAR NICHD WILL COORDINATE
FINALIZATION PUBLICATION OF THAT
INITIAL PRIORITY LIST.
THAT IS REALLY OUR PROCESS AND I
AM HAPPY TO ENTERTAIN QUESTIONS.
THANK YOU FOR YOUR ATTENTION.
>> THANK YOU FOR WALKING THROUGH
THE PRIORITIZATION.
HAVE THERE CLARIFICATION
QUESTION FOR CAMILLE BEFORE WE
OPEN THE CONVERSATION FOR A
BROADER DISCUSSION.
>> THAT'S A LONG TIME LINE OUT.
WHAT HAS BEEN THE NEXT STEP
AFTER THAT?
YOU HAVE PRIORITY THINGS THEN
WHAT?
>> AFTER THE INITIAL PRIORITY
LIST IN 2025?
>> MM-HMM.
>> IT WILL ULTIMATELY HELP SHAPE
THE FUNDING OPPORTUNITIES NIH
MAY DEVELOP.
THAT'S THE END GAME FOR WHAT WE
PLAN TO DO WITH THAT
INFORMATION.
>> PERFECT, THANK YOU.
>> SURE.
THANKS FOR YOUR QUESTION.
>> ANY CLARIFICATION QUESTIONS
BEFORE WE OPEN THE DISCUSSION?
HEARING NONE AND AFTER A SNIES
AWKWARD PAUSE I'LL INVITE
CAMILLE AND AARON AND NAHIDA TO
COME BACK ON CAMERA.
I THINK WE'LL OPEN THE
CONVERSATION TO BROADER
DISCUSSION BUT BEFORE WE DO
THAT, IF WE COULD PLEASE BRING
UP THE SLIDES FROM THE DECK ON
SESSION 1 SO I CAN REMIND
EVERYONE WHERE WE'LL BE FOCUS
ING -- AND WE'VE BEEN DISCUSSING
RECOMMENDATIONS 2,8, 9 AND 11 ON
CLINICAL AND BASIC SCIENCE
RESEARCH.
IF YOU CAN AND INCREASE THE
QUALITY, TIMELY AND QUANT AND
TIMELINESS OF RESEARCH ON SAFETY
AND EFFICACY AND PRODUCTS USED
BY PREGNANT WOMEN AND LACTATING
WOMEN AND THERE'S DISCUSSION ON
AWARDS PERIOD.
GOING TO RECOMMENDATION 8,
YOU'LL RECALL FROM OUR MEMO FROM
THE WORKING GROUP MEMBERS IT
SPECIFICALLY IS CALLING FOR A
PROCESS SIMILAR TO THE AGENCY
PROCESS AS A MODEL FOR THOSE
THAT AREN'T FAMILIAR IT'S A
LEGISLATIVE VEHICLE TO SIMULATE
DEVELOPMENT WHEREBY NIH HAS THE
ABILITY TO PUT OUT FOR THERE TO
BE PRODUCT DEVELOPMENT RELATED
TO THERAPEUTIC NEED AND CAMILLE
SPOKE THROUGH THE ACTIVITIES
ONGOING TO DEVELOP A PRIORITY
LIST AND WE HAVE NOTED WE WOULD
NOT DISCUSS RECOMMENDATION 8
BECAUSE THERE MAY BE NEED FOR
CONGRESSIONAL ACTIONS AND BASED
ON THE PROGRESS MADE IF THERE'S
ADDITIONAL DISCUSSION THE
COLLEAGUES WOULD LIKE TO HAVE
REGARDING 8B TODAY WE SHOULD GO
AHEAD AND ENTERTAIN THAT.
RECOMMENDATION NINE IS TO DRIVE
DISCOVERY AND DEVELOPMENT OF
THERAPEUTICS AND PRODUCTS FOR
CONDITIONS SPECIFIC TO PREGNANT
AND LACTATING WOMEN AND PART OF
ONE WAS IN THE REGARD TO THE
PRIORITIZATION PROJECT AND
SECOND WAS THE CONSIDERATION OF
NIH VACCINE MODEL.
SO WE HAVE PRE ADVISED WE WOULD
NOT DISCUSS 9B BECAUSE IT LIKELY
REQUIRES CONGRESSIONAL RESOURCES
AND 11 IS LEVERAGE ESTABLISHED
AND SUPPORT NEW INFRASTRUCTURES
AND COLLABORATIONS TO PERFORM
RESEARCH IN PREGNANT AND
LACTATING WOMEN AND WE THOUGHT
11A COULD BE ONE WE COULD NOT
DISCUSS TODAY BUT I THINK BASED
ON THE DISCUSSIONS WITH NAHIDA
AND AARON'S PRESENTATION WE
COULD LOOK AT MULTI-CENTER
INFRASTRUCTURES AND ONGOING
RESEARCH NETWORK AND TO
ENCOURAGE NETWORK AND
COLLABORATIONS TO ENGAGE IN
PUBLIC-PRIVATE PARTNERSHIPS.
WITH THAT QUICK OVERVIEW, I'D
LIKE TO OPEN THE DISCUSSION AND
SIMILAR TO HOW WE WORKED IN
NOVEMBER WE'LL GO AS FAR AS THE
TIME ALLOWS US TO GO.
WE HAD WONDERFUL PRESENTATIONS
TODAY FROM OUR NICHD COLLEAGUES.
SO IF WE'RE UNABLE TO GET
THROUGH ALL THE RECOMMENDATIONS
OFFLINE AS PREVIOUSLY MENTIONED
AND WORK WITH NIH STAFF AND PUT
TOGETHER A SUMMARY WITH OUR
PRODUCT ON WHERE WE THINK WE ARE
AND ASK ALL IN THE WORKING GROUP
TO WEIGH IN TO ADD OR TAKEAWAY.
WE'LL LOOK AT INCREASE THE
QUANTITY AND QUALITY AND
TIMELINESS OF RESEARCH ON SAFETY
AND EFFICACY OF THERAPEUTIC
PRODUCTS USED BY PREGNANT WOMEN
AND LACTATING WOMEN.
GOING BACK TO THE QUESTION FROM
THE FIRST PRESENTATION.
WITH A SYNTHESIS OF THE COMMENTS
THAT RELATE.
>> THERE WAS AN UNDERSTAND OF
THE ROAD BLOCKS DISCUSSED IF
THAT COULD BE ELABORATED ON AND
SPECIFIC TO LACTATION STUDIES.
IS THAT SOMETHING YOU'D LIKE TO
COVER?
>> THE INITIAL QUESTION IS WHO
WE FUND AND APPLICATIONS FOR
CLINICAL AND DATA COORDINATING
CENTERS OF OF THE APPLICATIONS
RECEIVED AND REVIEWED THEN WE
FUND X AMOUNT BASED ON
AVAILABILITY OF FUNDS AND I
QUESTION ABOUT RURAL POPULATIONS
WITHIN THE MATERNAL FETAL
MEDICINE UNIT NETWORK THE
APPLICANTS THAT CAME IN ARE THE
ONES THAT WERE REVIEWED FUNDED
AND THEY'RE PRIORITIZED WITHIN
WITHIN THE STEERING COMMITTEE OF
THE VARIOUS NETWORKS.
THERE'S ABILITY FOR OUTSIDE
RESEARCHERS IF INTERESTED THEY
CAN SUBMIT TO THE NETWORKS FOR
THOSE STUDIES.
WE DO CO-FUND NIAD THE IMPACT
NETWORK THEM AS A PRIMARY FUNDER
OF THE NETWORK AND NICHD
CO-FUNDS THAT NETWORK.
WE'VE BEEN DOING TRIALS AROUND
THERAPEUTICS OR LACTATION IN THE
NETWORK FOR A LONG TIME RELATED
TO HIV AND MEDICATIONS AROUND
USE OF MEDICATIONS IN PREGNANCY
AROUND HIV AND LACTATION AND
THERE WERE ALSO LEVERAGED FOR
THE COVID-19 LOOKING AT
MEDICATIONS FOR COVID AND NOW
HOPEFULLY FOR CRV DOWN THE LINE.
GO AHEAD.
>> THANK YOU, NAHIDA.
IT'S IMPORTANT TO UNDERSTAND THE
MAPPING AND WE KEEP REPEATING
PICKING SITES I'M NOT SEEING THE
SITES ACROSS NETWORKS
COLLABORATE AND ALL THESE SITES
ARE INSISTENCE FOR A DECADE PLUS
AND IT WOULD BE IMPORTANT TO
UNDERSTAND HOW THEY TALK TO EACH
OTHER BECAUSE THERE'S STRENGTH
IN WHAT THEY'RE DOING AND DO WE
NEED TO SEND OUT ANOTHER WHEN WE
HAVE SITES WITH EXPERTISE
THEY'RE DOING AND BY THE TIME
YOU GOT THE SITE UP AND RUNNING
AND KNOW RAVE AND REDCAP,
ETCETERA, THEY'RE REAPPLYING AND
ALL THE EFFORT GOES TO THAT.
WE ARE SILOING ALL THESE
NETWORKS OPPOSED TO PUTTING THEM
TO ONE UMBRELLA AND ENCOURAGING
SITES WHO PARTICIPATE IN ONE
NETWORK AND HERE'S A SCIENCE
IDEA.
WE'RE LOOKING FOR A SITE THAT
CAN DO X OR Y AND PULLING THEM
IN ACROSS THE NETWORKS OPPOSED
TO SILOING THEM WITHIN A
NETWORK.
>> THAT'S A GREAT POINT BUT
THERE'S VARIOUS EXPERTISE WITHIN
THE NETWORKS.
WHAT WE'RE INTERESTED IN IS
CROSS-NETWORK COLLABORATIONS AND
NOW WITH THE OPPORTUNITY TO OPEN
THE NETWORKS TO OUTSIDE
INVESTIGATORS THAT'S WHAT WE'RE
HOPING WOULD HAP JPEN YOU LOOK
THE SITE AND SEE IF THEY'RE ABLE
TO PARTICIPATE IN TRIALS.
FOR EXAMPLE, THERE'S PROPOSALS
THROUGH THE NEONATAL NETWORK AND
PROPOSALS LEVERAGING THE
PEDIATRICS TRIAL NETWORK.
BECAUSE WE HAVE DIFFERENT
EXPERTISE I DON'T THINK WE NEED
TO COMBINE THE RESEARCH SITES
AND SAY IF THERE'S AN X NUMBER
WE SHOULDN'T NECESSARILY FUND
THAT REGION OR INSTITUTION.
AND THE FIVE-YEAR CYCLE WAS
SHORT AND THE RECOMPETITION OF
THE NETWORK WENT TO SEVEN YEARS.
THEY WERE AWARDED IN 2023 AND
THEIR CYCLE IS SEVEN YEARS TO
2030.
>> IT SEEMS LIKE THERE'S A LOT
OF INTEREST IN THIS IN THE TIME
LINE FOR THE AWARD PERIOD AND
ARE THERE QUESTIONS ON WHAT THAT
COULD LOOK LIKE OR HAVE
DISCUSSION WHERE THE NEED MAY BE
IN MATERIALS OF THE SHORT CYCLE
PERIOD FOR THE AWARDS?
THAT'S A CHANGE FOR FMU BUT WHY
IT WOULD MATTER FOR OTHER
AUTHORITIES.
ALL THREE NETWORKS WITHIN THE
BRANCH FOR THE GLOBAL RESEARCH
NETWORK AND FMU ARE SEVEN-YEAR
CYCLES.
IN GENERAL WE'RE HOPING WE COULD
DO THE SAME FOR ALL NETWORKS BUT
FOR THE THREE THAT HAVE
RECOMPETED THIS YEAR, THAT'S THE
CYCLE INCREASED FROM SEVEN TO
FIVE YEARS.
>> ANY THOUGHTS ON THIS QUESTION
RELATED TO 2B.
>> IS THERE GOING TO BE A
CLEARING HOUSE FOR INVESTIGATORS
THAT SAYS HERE'S THE SCIENCE
QUESTION, ARE YOU A SITE IN
ANOTHER NETWORK YOU CAN APPLY TO
BE A SITE FOR THIS SCIENCE
QUESTION OR IS THERE A CLEARING
HOUSE THAT SAYS WE'RE LOOKING
FOR CLINICAL TRIALS ON X OR Y
AND HERE HOW IT'S SUBMITTED.
BECAUSE OF THE SILOING, MOST
PEOPLE DON'T KNOW HOW TO ACROSS
INTO THE OTHER NETWORKS.
>> GREAT POINT, SHARON.
SO AS YOU KNOW, THE
INVESTIGATORS ARE THE ONES THAT
PROPOSE TRIALS TO NICHD.
DOES NOT GO OUT AND SAY WE WANT
A TRIAL IN X, Y, Z.
IT'S THE PRIORITIES OF THE
VARIOUS NETWORKS AND THE P.I.s
HAVE BEEN DOING OUTREACH BUT
WE'VE BEEN THINKING ABOUT IF
THERE'S A PARTICULAR STUDY AND
WE NEED ADDITIONAL RECRUITMENT
SITES HOW THAT WOULD WORK.
IT'S A GREAT POINT AND SOMETHING
TO CONSIDER FOR US.
>> THANK YOU.
DID SEE THERE'S ANOTHER QUESTION
COMING UP FROM TINA BUT I WANT
TO ADDRESS A QUESTION THAT'S
COME UP A COUPLE TIMES IN
REGARDS TO THE PRE-CLINICAL
STUDIES.
I DON'T KNOW IF DR. ELESE WANTED
TO COME BACK AND TALK ABOUT THE
TRANSITIONAL SPACE.
>> THIS IS TONY.
IN LOOK AT THE NEED FOR THE
PREOR MODIFIED STUDY I SAW A FEW
LISTED IN THE SLIDE BUT I'M
STRUGGLING TO UNDERSTAND HOW
THOSE MAY BE USED WITHIN
INDUSTRY EARLIER BECAUSE I THINK
THE PHARMA INDUSTRY IS IN A
PERFECT PLACE TO DEVELOP DATA
THAT MAYBE ABLE TO HELP WITHIN
CLINICAL TRIALS OR HELP
MARKETING CLINICAL TRIALS,
THINGS OF THAT NATURE.
IT WOULD BE NICE TO SEE A
NETWORK THAT MIGHT BE FORMED.
I KNOW IN THE PRGLAC
IMPLEMENTATION GUIDE IT TALKS
ABOUT THE FIRST STEP BEING A
WORKING GROUP SO IF THAT'S A
POSSIBILITY OR IT MAYBE HELPFUL
IF IF IT'S MADE KNOWN MORE
WIDELY SO PEOPLE CAN
PARTICIPATE.
>> ONE IS A PUSH TO HAVE MODELS
MORE PREDICTIVE OR COMPLEMENT
WHAT'S TYPICALLY DONE IN ANIMAL
MODELS AND IN AN AREA WHERE
ANIMAL MODELS ARE NOT AS
REFLECTIVE.
THE COMPLIMENTARY PROGRAM IS
ALSO BUILT ON A GROUP AND WE'VE
HAD A PRIMARY REPRESENTATIVE.
THERE'S AN A LOT OF INPUT FROM
THE FDA AND REGULATORS
RECOGNIZING THE NEED FOR THESE
BETTER MODELS.
THAT WILL INCLUDE USING DATA.
THE COMPLEMENTARY PROGRAM IS
VERY MUCH LOOKING AT IN SILLICA
MODELS AND WHAT WE CAN DO WITH
MORE DATA AND LOOKING AT OTHER
CONSTRUCTS AND NOVEL AND
CHEMICAL APPROACHES THAT COULD
BE USED FOR PREDICTIVE
CAPABILITY.
SOME ACTIVITIES THE
COMPLIMENTARY WORKING GROUP HAS
UNDERTAKEN AS IT'S BEEN SCOPING
OUT WHAT IT CAN POTENTIALLY DO
IS HAVING A LARGE WORKING GROUP
AND ENGAGEMENT WITH THE
FOUNDATION FOR THE NIH AND
RUDOLPH FOUNDATION AND MILKEN
INSTITUTE.
THE GOAL IS FOR TO AND ENHANCING
THE STUDIES IS VERY MUCH ON
FOLKS' MINDS.
WE'RE HOPING IT CAN BE SOMETHING
AND WOULD BE GREAT TO MOVE FROM
DRUG DEVELOPMENT INTO THE DRUG
DISCOVERY PHASE AND CLINICAL
SCAFFOLDS AND THERAPEUTICS CAN
HAVE PROPERTIES THAT MAY BE
LIABILITIES DOWN THE ROAD IN
TERMS OF ELIMINATING MORE AND
EARLIER IN THE PROCESS AND I
THINK WE'RE IN A GOOD DIRECTION
WITH COMPLIMENTARY.
>> THANK YOU, AARON.
IT LOOKS LIKE THAT RESOLVED
BECKY'S QUESTION AS WELL SO
THANK YOU.
TINA, I THINK I SAW YOUR LAND
NEXT.
>> IF THERE WOULD BE AN OVERLAY
WHERE OTHER NETWORKS EXIST AND
INCENTIVIZATION FOR AND
ACCELERATE RESEARCH INITIATIVES
WHERE THERE'S EXISTING
INFRASTRUCTURE AND COULD WORK
ACROSS THE PREGNANCY AND
LACTATION SPACE SATION NEONATAL
-- SAYING NEONATAL NETWORK AND
FMU.
>> THERE'S CROSS-REFERENCE AND
WE'LL COME BACK TO IT.
ANY RESPONSE?
>> AND THIS IS DIRECTED TO
NAHIDA, I'VE BEEN LISTENING TO
THE WONDERFUL WORK OF THE
NETWORK AND AT THE VERY END OF
YOUR LAST COMMENT I SAW THE NEED
OF WHAT I'VE BEEN WANTING TO
HEAR THAT IS THAT THE
INVESTIGATORS INITIATE THE
PROPOSALS.
IS THERE EVER A POSSIBILITY
WHERE THERE ARE PRIORITIES
ESTABLISHED FOR PROPOSALS SO
THEY MAY POSSIBLY ALIGN WITH THE
PREG LACK BEING MORE DIRECTIVE
SO THAT RESEARCH IS -- DOES THAT
MAKE SENSE?
>> MAKES SPENCE IT'S A BALANCE
BETWEEN WHAT THE EXERTS IN THE
AREA THINK IS A PRIORITY FOR
RESEARCH VERSUS WHAT WE TELL
INVESTIGATORS TO DO AND WHEN WE
HAD ADDITIONAL DOLLARS LIKE
DURING COVID WE SAID YOU'RE IN
THE FIELD WHAT CAN YOU DO AND
THEY CAME UP WITH A PROPOSAL OF
WHAT WOULD BE DONE.
FOR EXAMPLE, THE RECOVER
ACTIVITIES AND SIMILAR FOR THE
IMPACT NETWORK CHILDREN
MENTIONED.
THERE'D OPPORTUNITIES IF THERE'S
A SPECIFIC NEED TO SAY WE HAVE
ADDITIONAL FUNDS AND WHAT CAN
YOU DO WITH THESE.
SAME FOR THE HEAL ACTIVITIES
THERE WAS A PROTOCOL TO LOOK AT
REDUCING OPIOID USE IN
POST-CAESAREAN DELIVERIES.
THERE'S OPPORTUNITIES BUT THE
MAIN ACTIVITIES AND THE
PRIORITIES OF THE NETWORK ARE
LED BY THE VARIOUS NETWORKS AND
WHY THEY WERE SELECTED.
>> THANK YOU.
>> I'M GOING TO SUGGEST WE MOVE
TO RECOMMENDATION 8 BUT IF YOU
CONTINUE TO HAVE THOUGHTS IN
REGARDS TO RECOMMENDATION 2 NOTE
IT IN THE CHAT THAT IT'S
SPECIFIC TO RECOMMENDATION 2 SO
WHEN WE REVIEW THE COMMENTS WE
UNDERSTAND WHAT IT WAS LINKED TO
TO ENSURE WE ADEQUATELY COVERED
THE PROGRESS TO DATE.
RECOMMENDATION 8 AS YOU RECALL
WE HAD ADVISED WE WOULD NOT BE
DISCUSSING TODAY BUT IT'S CLEAR
FROM WHAT WAS OUTLINED THAT
NICHD IS ALREADY MADE PROGRESS
ON PRIORITIZATION AND THERE WILL
BE MORE TO FOLLOW.
WHILE THERE'S RECOMMENDATIONS
NICHD DEVELOPED PROCESSES FOR
PREGNANT AND LACTATING WOMEN.
WANT TO DISCUSS 9A TO THE
RECOMMENDATION.
IN TERMS OF PROGRAMS TO DRIVE
DISCOVERY AND DEVELOPMENT OF
THERAPEUTICS, I WANT TO MAKE
SURE WE'RE LISTENING TO YOUR
THOUGHTS AND DISCUSSION IN TERMS
OF WHERE WE ARE IN TERMS OF
PROGRESS TO DATE FOR 9A.
>> THIS IS ALLENI.
I HAVE ONE QUESTION AND ONE SIDE
NOTE YOU REFERENCED ME AS
DR. TSIGAS I APPRECIATE THE
PROMOTION BUT I'LL SOUND MORE
IGNORANT THAN I SHOULD.
I'M NOT A DOCTOR.
I'M A CONSUMER REPRESENTATIVE TO
THE GROUP.
I DON'T HAVE A PROBLEM THAT
THERE HASN'T BEEN SUFFICIENT
WORK.
I WOULD BE INTERESTED AND THIS
IS PROBABLY AN OFFLINE
CONVERSATION IN UNDERSTANDING
WHAT THE GROUP CONSIDERS NEEDED
CONGRESSIONAL ACTION SO THOSE OF
US INVOLVED IN ADVOCACY COULD
ALIGN AS A SEPARATE ACTIVITY.
THAT'S MY COMMENT.
>> IT'S OUR FEELING THERE MAY BE
ADDITIONAL RESOURCES NECESSARY
TO PUT ACTIVITIES SUCH AS THE
BARDA LIKE MODEL IN PLACE.
GIVEN THAT WE DO BELIEVE THERE'S
NEED FOR THERE TO BE ADDITIONAL
CONSIDERATION CONGRESSIONALLY
AROUND WHAT THAT WOULD BE LIKE
TO ADEQUATELY SUPPORT AND SOME
COULD NEED THAT SUPPORT.
THESE ARE THINGS ANTICIPATED OR
EXPECTED THERE MAY BE MORE WORK
THAT NEEDS TO BE DONE OUTSIDE
THE ORIGINAL RECOMMENDATIONS
MADE.
WE UNDERSTAND IT'S AN EVOLUTION
AND IT'S IMPORTANT TO GUIDE THE
HANDS TO PUT ADDITIONAL POLICY
IN PLACE TO SUPPORT THE
RECOMMENDATIONS.
DOES THAT ANSWER THE QUESTION?
WE'RE NOT GOING TO IGNORE IT IN
THE REPORT BUT THERE'S MORE THAT
NEEDS TO BE DONE.
ANY COMMENTS IN REGARDS TO 58B
OR 9A AND THEN WE'LL MOVE ON TO
RECOMMENDATION 11.
SO RECOMMENDATION 11 IS QUITE
EXTENSIVE TO LEVERAGE
ESTABLISHED AND SUPPORT NEW
INFRASTRUCTURES/COLLABORATIONS
TO PERFORM RESEARCH IN PREGNANT
AND LACTATING WOMEN.
WHEN I GAVE THE OVERVIEW I THINK
WE SHOULD DISCUSS 11A, 11B AND
11C BECAUSE IT'S CLEAR THERE'S
WORK IN THESE SPACES.
I'M HAPPY TO OPEN BACK UP IN
REGARDS TO THE RESEARCH
INFRASTRUCTURE AND NETWORKS.
>> OF WHAT AARON TALKED ABOUT I
THINK ADDRESSES THAT IN TERMS
OF -- I'M FAMILIAR WITH THAT IN
TERMS OF PROVIDING ADDITIONAL
RESOURCES WHERE AN
INFRASTRUCTURE ALREADY EXISTS TO
EXPAND AND ENHANCE THAT AND
THAT'S A TREMENDOUS MOVE IN THE
RIGHT DIRECTION.
WOULD LIKE TO SEE MORE OF THAT.
THANK YOU, TINA.
>> I WAS THINKING OF METRICS AND
HOW THAT WILL BE USED TO BRING
IN NEW SITES.
IT'S NICE THE NETWORK HAS A
STUDY THEY THINK IS A HIGH
IMPORTANT PRIORITY BUT IT TAKES
FOUR AREAS TO ENROLL.
OFTEN TIMES BY THE TIME YOU GET
THE DATA ARE WE IN THE RIGHT
PLACE AND WE LOOK AT THE METRICS
FOR THE SITES, WHO IS DOING WHAT
AND SHOULD WE GET MORE SITES AND
ONE THING I'D LIKE TO SEE ACROSS
THESE NETWORKS AND SITES IS
COMMONALITY OF LANGUAGE ON
METRICS OR SITES SO WE CAN SAY
YOU HAVE A STUDY YOU HAVE AN
ADDITIONAL THREE SITES AND LET'S
FIND THE THREE SITES AND HERE'S
THE SITES WE COULD APPLY FOR
THIS AND HERE'S THE METRICS AND
TIMELINESS AND BRING THE IN.
TIME IS MONEY AND YOU GET THE
ANSWER QUICKER AND MEANS MORE.
WE CAB UNDERSTAND AS NETWORK
LEADERS OR INVESTIGATORS WHO TO
PICK, WHAT TO PICK TO GET THE
STUDIES DONE SOONER.
AS BE AN ASIDE, THAT IS VERY
IMPORTANT TO SOME OF OUR PHARMA
PARTNERS WE CAN SAY HERE'S THE
METRICS AND WE CAN PICK THE
SITES WE CAN GET YOUR ANSWER AND
HERE'S THE ONES THAT GO RESEARCH
AND THAT WOULD MAKE SENSE AND
BOOST ALL THE NETWORKS.
I'LL STOP THERE.
>> I THINK IT'S SOMETHING TO
CONSIDER.
TO GO BACK SINCE I KNEW MORE
ABOUT THE IMPACT NETWORK AND
LIKE THE IDEA OF POTENTIALLY
HAVING MULTIPLE SITES.
THE IMPACT NETWORK IS YOU HAVE
26, 30 SITES GLOBALLY YOU CAN
ENROLL IN A PARTICULAR STUDY AND
LOOK AT THE PROTOCOL TO ENROLL
IN THE STUDY.
THE DIFFERENCE IS THIS IS FOR
THE 14 SITES HAVE HAD TO MET THE
MINIMAL REQUIREMENT FOR THEM TO
BE A SITE.
MEANING THEY HAVE TO HAVE THE
NUMBER HIGH RISK WOMEN AND HAVE
TO HAVE X AMOUNT OF DELIVERIES
AT THEIR SITES AND THE NUMBER OF
SITES THAT IS INVOLVED.
THE EXPECT FOR THE NETWORK ANY
PROTOCOL FROM THE NETWORK IS
APPROVED BY THE STEERING
COMMITTEE AND NIH WOULD BE
RECRUITING FROM ALL THE SITES
PART OF THE NETWORK.
I THINK THE RESTRUCTURING TO SAY
TO KEEP THAT AND IS A THERE'S
OTHER NICHD NETWORKS THAT COULD
BE LEVERAGED IF THERE'S A
PROTOCOL THAT REQUIRES 10,000
WOMEN OPPOSED TO 4,000 WOMEN.
THAT ALSO TAKES INTO CROSS THERE
MAY BE NEEDED ADDITIONAL FUNDS
TO BRING ON SITES NOT PART OF
THE EXISTING NETWORK THAT WE
PROVIDE INFRASTRUCTURE FOR.
LOOKING AT THE DIFFERENT
STRUCTURE WITHIN NICHD AND THEN
WE POTENTIALLY CO-FUND AND SEE
HOW WE CAN HAVE READY SITES THAT
COULD PARTICIPATE.
AS AN EXAMPLE THIS WAS DONE FOR
THE CMV BETWEEN THE FMU AND
IMPACT BECAUSE THE CMV TRIAL WAS
NOT ENROLLING AND WE ADDED SITES
TO PARTICIPATE IN THE STUDY.
THERE IS PRECEDENT TO HOW THIS
WAS DONE BUT I THINK MAYBE
HAVING A CLEARING HOUSE IS A
GOOD IDEA.
>> THOSE ISSUES CAN BE WORKED
OUT.
FROM MY PERSPECTIVE, THE TIME
ELEMENT AND WHO IS TRACKING HOW
LONG THE STUDY TAKES TO ENROLL
IS AN ISSUE.
WITH THE SINGLE IRB I WANT TO
SAY SOME OF THAT TIME TO OPEN
THE SITE HAS CHANGED.
THERE'S DIFFERENT ISSUES ON BOTH
SIDES BUT IF WE'RE THINKING
ABOUT THAT NET GENERATION OF
STUDIES, THIS IS THE TIME TO SAY
WHAT WE'VE DONE TO NOW MAYBE
WORKS BUT WE CAN DO IT BETTER
AND HERE'S THINGS TO THINK
ABOUT.
THEY TALKED ABOUT PART NERGZ
WITH OTHER AND PARTNERING WITH
OTHERS WE DON'T TRADITIONALLY
PARTNER WITH AND THEY PART NERD
TO COMPLETE THE ACT NOW TRIALS.
WE HAVE EXPERIENCE.
IT'S SOMETHING THAT SHOULD BE
CONSIDERED AND IT'S NOT
IMPOSSIBLE TO THINK HOW DO WE
BRING ON SITES THAT DO NOT
CURRENTLY RECEIVE SUPPORT FROM
THE FOR THE INFRASTRUCTURE.
GREAT SUGGESTION AND WE CAN LOOK
AT WHERE THEY ARE AND WHERE THE
NEEDS ARE.
>> MAYBE IT WOULD BE INTEREST TO
THINK OF THE COMPONENTS OF THIS
RECOMMENDATION WE'RE TALKING
ABOUT EXPANSION OF NETWORKS TO
REALLY THINK ABOUT FOSTERING
PUBLIC-PRIVATE PARTNERSHIPS AND
HOW WE BETTER INCORPORATE IN
DIFFERENT STAKEHOLDER GROUPS
THAT MAY BE ABLE TO HELP
FACILITATE BRINGING SOME OF THE
NEW THERAPEUTIC DEVELOPMENTS
GOING FORWARD FROM TRANSLATIONAL
TO CLINICAL DEVELOPMENT.
I'M INTERESTED UP HEARING
THOUGHTS FROM THE GROUP ON WHAT
YOU HEARD ABOUT TODAY AND WHERE
WE TODAY AND MAY NEED TO
PROGRESS TO TO BEST FACILITATE
THE PUBLIC PRIVATE PARTNERSHIPS.
TINA.
>> I'M NOT SURE IF THIS WITH
WHERE YOU WERE GOING BUT THERE'S
GREAT OPPORTUNITY IN
PUBLIC-PRIVATE PARTNERSHIPS IN
LACTATION AND PREGNANCY AND
UNDER THE TERM EN IS THERE A
PROCESS IN PLACE OR IS ANYBODY
ENGAGED IN EDUCATING OR BRING
THIS ISSUE TO THE PRIVATE PART
OF THE PUBLIC-PRIVATE
PARTNERSHIP SO THEY CAN
APPRECIATE THE BENEFITS AND
GAINS THAT COULD BE APPRECIATED
BY ESTABLISHING THOSE KINDS OF
COLLABORATIONS TO FACILITATE
RESEARCH.
I WONDER IF IT HAPPENS BY
HAPPENSTANCE THAN PROMOTING SUCH
METHODS FOR GETTING THE WORK
DONE.
>> THANK YOU, TINA.
I DON'T WANT TO PUT COLLEAGUES
ON THE SPOT BUT I KNOW THERE ARE
SOME COLLEAGUES IN THE WORKING
GROUP PARTICIPATING IN THE
EUROPEAN CONCEPTION AND WANT TO
KNOW IF YOU CAN TALK ABOUT THAT
AND AS A MODEL TO ADDRESS THE
NEEDS SPECIFIC TO LACTATION?
NO ONE WANTS TO SPEAK, I GUESS.
I WONDER IF I CAN ASK MY
COLLEAGUE TO SPEAK WITH THE
ACTIVITIES HE'S WORKING ON AS A
WORK PACKAGE LEAD THROUGH
CONCEPTION.
>> SURE.
I'M WORKING ON THE PRECLINICAL
WORK PACKAGE FOR THE CONCEPTION
PROJECT.
WORK PACKAGE 3 IS TRYING TO
IDENTIFY AN ALTERNATIVE
PRE-CLINICAL MODEL TO LOOK AT
DRUG TRANSFER VIA LACTATION AND
LOOKING AT THE GUINEA PIG AS AN
ALTERNATIVE MODEL FROM THE MILK
COMPOSITION PERSPECTIVE IT'S
MOST SIMILAR TO SOME OF THE
SPECIES WE LOOKED AT TO HUMANS.
AND EVEN SOME OF THE PHYSIOLOGY
IS CLOSE TO THE HUMAN AND
LOOKING AT COMPOUNDS IN THE MINI
PIG TO COMPARE TO AVAILABLE
HUMAN DATA TO SEE IF THAT MODEL
IS TRANSLATABLE TO HUMAN DATA
ALREADY AVAILABLE.
IT'S LIMITED.
WE DON'T HAVE A LOT OF
COMPOUNDS.
THERE COULD BE CERTAIN MODAL
MODALITIES OF DRUGS BETTER
SUITED FOR USE IN THE MINI PIG
THAN OTHERS.
THAT COULD BE INVESTIGATED
POSTCONCEPTION PROJECT BUT WE'RE
LIMITED IN THE NUMBER OF
COMPOUNDS WE CAN LOOK AT.
WE'RE LOOKING AT COEFFICIENTS OF
DRUGS IN MAMMARY TISSUE AND ALSO
DEVELOPING PDPT MODELS TO
PREDICT DRUG EXPOSURE IN AN
INFANT THROUGH NURSING.
WE'RE LOOKING AT MATERNAL MODELS
AND MATERNAL INFANT MODELS TO
TRY TO DEVELOP MODEL CAN BE USED
AND WORK PACKAGE THREE IS GOING
TO EMA TRYING TO GET
QUALIFICATION ADVICE AND IF THE
DATA'S STRONG ENOUGH WE MAY BE
ABLE TO GET QUALIFICATION
OPINION.
IT'S GOING TO BE CHALLENGING
BECAUSE WE MAY NOT HAVE
SUFFICIENT DATA FOR THEM TO GIVE
US A QUALIFICATION OPINION
BECAUSE OF LIMITED TIME WE HAVE
BUT AT LEAST WE'LL HAVE
QUALIFICATION ADVICE AND
QUALIFICATIONS FROM EMA TO GET
FEEDBACK ON THE VARIOUS MODELS
WE'RE DEVELOPING.
>> THERE'S FUNDING THROUGH THE
PRIVATE SECTOR AND PUBLIC SECTOR
AND THIS PRODUCT IS ENTIRELY
DEDICATED TO LACTATION STUDIES
AND WONDERING IF I CAN PUT YOU
ON THE SPOT AGAIN.
TALK A LITTLE BIT TO WHAT SOME
OF THE DRIVING FORCE S ARE
BEHIND WHAT BROUGHT THE PUBLIC
SECTOR TO THE TABLE AND WHAT
WERE THINGS THAT LED THE PRIVATE
SECTOR TO SAY WE WANT TO HAVE
THIS PARTNERSHIP?
THIS MAY HELP INFORM PERHAPS
SOME OF THE DISCUSSION AS A
WORKING GROUP WE MAY WANT TO PUT
INTO OUR REPORT BACK TO CONGRESS
WITH ADDITIONAL WORK IN THE
SPACE.
>> FROM MY PERSPECTIVE, I WAS
ONE OF THE TWO INDIVIDUALS THAT
STARTED IT OUT AND IT STARTED AS
A PRE CLINICAL PROJECT BUT AS WE
STARTED TO DISCUSS WITH OTHER
PRIVATE PARTNERS AND PUBLIC
PARTNERS IT QUICKLY GREW INTO
WHAT IT IS TODAY WITH MULTIPLE
WORK PACKAGES LOOKING AT MILK
BIO BANKS, CLINICAL TRIALS,
EVERYTHING.
IT BALLOONED INTO WHAT IT IS
TODAY.
I THINK SOME IMPETUS BEHIND IT
IS THERE'S DATA GAPS WHEN WE ARE
DEVELOPING DRUGS AND ONE OF
WHICH IS THE LACTATION ASPECT
FOR OUR LABELS.
WE TYPICALLY DO NOT COLLECT ANY
DATA IN OUR ANIMAL MODELS OR
LIMITED DATA WITH RESPECT TO
DRUG TRANSFER VIA THE MILK INTO
THE OFFSPRING.
WITHOUT THAT IT HANDCUFFS TO THE
RECOMMENDATIONS WHETHER IT'S
SAFE OR NOT.
ONE REASON WE ENTERED INTO THIS
IS TO TRY TO HELP FILL THAT GAP
AND COME UP WITH A MODEL SYSTEM
THAT IS USABLE AND TRANSLATABLE
TO HUMANS TO PROVIDE SOME DATA
OR INFORMATION IN OUR LABELS AT
THE TIME OF DRUG APPROVAL THAT
WOULD BE USEFUL TO A PHYSICIAN
TO USE THE DRUG AND ASSUME
WITHIN THE OTHER WORK PACKAGES
IT'S ALSO SIMILAR.
IT'S TRYING TO GET THE HUMAN
DATA THAT WOULD BE USEFUL AND
PROVIDE DIFFERENT DATA WE WOULD
NOT BE ABLE TO GET FROM ANIMAL
MODELS.
>> IT'S IMPORTANT TO SHARE WHAT
MAY BE THE WAYS TO BE AN
ENTICEMENT OR INDUCEMENT TO BE
COLLABORATIVE OPPORTUNITIES FOR
PUBLIC-PRIVATE PARTNERSHIP.
I'M INTERESTED IN AARON.
I'LL ASK A QUESTION TO YOU DO
YOU SEE IN THE WORK BEING DONE
ON YOUR SIDE WHERE THERE'S SOME
OPPORTUNITIES TO EXPAND BEYOND
TO THINK WHERE THERE MAY BE
COMMON GROUNDS TO BEGIN TO DO
SOME OF THE BROADER
PUBLIC-PRIVATE PARTNERING I KNOW
THROUGH FNIH THERE'S A WAY TO
ESTABLISH IT QUITE EFFECTIVELY
BUT WONDERING IF THERE'S
SOMETHING YOU'D LIKE TO SPEAK TO
THERE.
THE FOUNDATION FOR THE NIH IS
INTERESTED IN EXPANDING CLINICAL
HEALTH AND EXPANDING THAT IS A
POTENTIAL AND MOSTLY IN THE DRUG
TARGET VALIDATION AND
DEVELOPMENT SPACE ONE OF THE
CHALLENGES IN DISCUSSING
LACTATION OR PREGNANCY IN REGARD
TO PUBLIC-PRIVATE PARTNERSHIPS
IS IDENTIFYING THE INDIVIDUALS
WITHIN A CONDITION THAT ARE
CHAMPIONS FOR THIS KIND OF
RESEARCH.
I MAY KNOW AN INDIVIDUAL IS
DOING SOMETHING OR VERY
DEVELOPED IN LACTATION RESEARCH
AND REPRESENTATIVES FROM THE
SAME COMPANY WILL SAY WELL,
THAT'S SOMETHING THE COMPANY'S
NOT INTERESTED IN.
THAT MAY BE SOMETHING TO FIND
THOSE WILLING TO COME TO THE
TABLE AS CONVENERS AND
COMPLEMENTARY WILL PROVIDE A
GREAT VENUE FOR THAT SPACE AND
THERE'LL BE A GREAT OPPORTUNITY
AND THROUGH THAT PERHAPS WE CAN
START TO BUILD UP MORE OF A
COALITION OF DEVELOPS THAT
REPRESENT COMPANIES WILLING TO
ENGAGE AND ENGAGE IN THE PRIVATE
SIDE OF THE PUBLIC-PRIVATE
PARTNERSHIPS.
>> THANKS, AARON.
>> THERE'S DISEASE-BASED
REGISTRIES.
A SINGLE-DRUG BASED REGISTRY WE
HEARD ABOUT RECRUITMENT AND HOW
LONG IT TAKES.
I WANTED TO REITERATE THERE'S
ANY OPPORTUNITY FOR
COLLABORATION ACROSS THE BOARD
IN THE PUBLIC PRIVATE SECTOR
WHICH MAY ALLOW US TO GET MORE
INFORMATION .
THANK YOU.
I APOLOGIZE I CHIMED IN AND MAY
HAVE INTERRUPTED.
>> ONE OF THE OPPORTUNITIES I
SEE IN THE CHAT TOO ABOUT THE
FINE LINE BETWEEN WHAT WOULD BE
PUBLICLY FUNDED OR INDUSTRY
REQUIRED CONVENERS THAT EXIST
AND THE CRITICAL PATH INSTITUTE.
I WONDER IF THAT'S A WAY TO
BRING PEOPLE TOGETHER AND IT
SEEMS WITH A PLATFORM THAT COULD
BE CONSIDERED TO CREATE A PLACE
WHERE THOSE CAN CONTRIBUTE TO
THE IDEA OF A DISEASE-BASED
REGISTRY.
I DON'T THINK WHERE WE'RE GOING
TO GET TO BE WITHOUT IT.
I WOULD THINK THE COMMITTEE
WOULD WANT TO PUT FORWARD AS A
RECOMMENDATION SOME WAYS THAT
COULD DIRECTLY BE USED TO START
AND CREATE DISEASE-BASED
REGISTRIES.
AND MODELS LIKE THE IMI
CONCEPTION ARE AN EXAMPLE.
>> TWO THINGS ON LACTATION AND
HUMAN MILK.
THE QUESTION OF WHAT IS THE
EFFECTS NOT ONLY OF THE DRUGS IN
MILK BUT THE OF TAKING THAT
MEDICATION ON THE MUMAN M -- HU
MILK SUPPLY AND I'M NOT AWARE OF
MUCH OUTSIDE THE MPRINT HUB AND
I'M FOCUSSED ON THAT AND MAYBE
OTHERS CAN COMMENT ON THAT AS
WELL.
IT'S IMPORTANT.
AT THE LAST MPRINT MEETING SOME
COLLEAGUES RAISED IT UP AND WE
COULD IDENTIFY SOME TYPE OF
BIOMARKER OR RELATIVELY SIMPLE
ASSESSMENT FOR MILK QUALITY AND
LEVEL.
I DON'T THINK IT'S THE FULL
EXTENSIVE METABOLOMICS YOU CAN
DO IN THE LAB.
AND JULIE RAISED THIS EARLIER IN
TERMS OF THE OVERSEEING IN TERMS
OF THE LAC, THERE'S NOT AS MANY
APPLICATIONS LOOKING AT
THERAPEUTICS RELATED TO
LACTATION.
I THINK THAT GETS TO MILK SUPPLY
QUALITY AND CONDITIONS LIKE
MASTITIS THAT MAY OCCUR DURING
LACTATION.
WE MAY NEED TO LOOK CLOSER TO
UNDERSTAND WHY THINGS AREN'T
MOVING FORWARD THERE AND ONE
PART MAY BE THE LACK OF --
LACTATION AND ISSUES WITH
LACTATION I DON'T THINK ARE
CAPTURED OR EXTRACTED AS WELL
FROM EHRs AND THERE MAY BE NOT
AS MUCH TRACKING AND HOW DOES
ONE ASSESS QUALITY OF HUMAN
MILK.
THE OVER ALL LACK OF STUDY ON
LACTATION MAY BE ONE OF THE
DRIVERS OR INHIBITERS WITH
TARGET VALIDATION.
THAT MAY BE A CONSIDERATION FOR
WHAT ADDITIONAL RECOMMENDATIONS
MAY BE.
>> I APPRECIATE THOSE ADDITIONAL
COMMENTS.
I WANT TO ACKNOWLEDGE THERE WAS
A COMMENT IN TERMS OF THE AFFECT
TRANSFER OF THERAPEUTIC TO THE
MILK VERSUS LOW MILK SUPPLY.
THAT'S AN IMPORTANT POINT WELL
TAKEN.
IT'S ALSO HIGHLIGHT ED AND WE'R
NOT LIMITING IT TO WHETHER OR
NOT THERE'S NEEDS WITHIN THE
LACTATION COMMUNITY.
OTHER COMMENTS FOR DISCUSSION.
THERE WERE OTHER ASPECTS TO
THESE RECOMMENDATIONS.
AND THINK OF EFFECTIVENESS
TRIALS OR CASE CONTROL STUDIES.
I DON'T KNOW IF ANYONE WANTS TO
ADDRESS THE ASPECTS OF HOW TO
THINK ABOUT GENERATING THE DATA.
WE ARE ASKING INDIVIDUALS TO
THINK OF INNOVATIVE DESIGNS AS
THEY PROPOSE THEIR IDEAS AND SO
THAT'S SOMETHING NICHD IS
ENCOURAGING THINKING ABOUT
INNOVATIVE DESIGNS PLATFORM
TRIALS AND THINK OF THAT NATURE
THAT COULD POTENTIALLY BE --
>> THANK YOU.
GO AHEAD.
>> A LITTLE BIT ABOUT CASE
CONTROL STUDIES, WITH MORE OF A
LACTAT
LACTATION HAT ON, I DON'T KNOW
IF WE IDENTIFIED WAYS TO STUDY
LACTATION OR LACK OF MILK
PRODUCTION, FOR INSTANCE SO WE
COULD DO CASE CONTROL STUDIES
THERE JUST YET.
IF WE ASSUME THE CASE WOULD BE A
WOMAN WITH LOW OR NO MILK
PRODUCTION.
THAT WOULD BE CHALLENGING BUT
FOR BIRTH DEFECTS AND STILLBORN
WE'RE LOOKING AT MEDICATION USE
AND PREGNANCY.
THAT'S IN RESPONSE TO THE CASE
CONTROL QUESTION.
>> I'D LIKE TO FOLLOW THE
COMMENT IN THE WORK I DO --
>> I GUESS THAT WOULD BRANDON
BECOMES --
>> WORKING WITH ELECTRONIC
HEALTH RECORD IT WOULD BE
DESIRABLE BUT IT'S DIFFICULT TO
CAPTURE ADEQUATE INFORMATION ON
LACTATION BECAUSE IT'S A DYNAMIC
PROCESS AND TO GATHER
INFORMATION THAT'S MEANING FFULN
AN ELECTRONIC HEALTH RECORDED
NOT SIMPLE AND YOU HAVE TO ASK
YOURSELF WHAT YOU'RE GOING TO
INTERPRET FROM THAT POINT IN
TIME FROM THAT ONE RECORD.
I WANTED TO POINT THAT OUT.
I'M NOT SURE WE FOUND THE MOST
FRUITFUL WAY TO STUDY.
>> I THINK WHAT I'M HEARING FROM
THE LAST TWO COMMENTS IS THERE
MAY BE DIFFERENT TRIAL DESIGN
NEEDS BETWEEN PREGNANCY
THERAPEUTIC STUDIES AND
LACTATION THERAPEUTIC STUDIES
AND NEED TO BE CLEAR ABOUT THAT
WHEN WE'RE PROVIDING OUR
PROGRESS REPORT.
GO AHEAD, TONY.
>> TO FOLLOW UP WITH RESPECT TO
RELATIONSHIPS WITH INDUSTRY.
I'D QUANTITY TO KNOW WHAT
PROGRESS IS BEING MADE WITH
RESPECT TO TRYING TO UNDERSTAND
THE DATA NEEDED FOR PREGNANT AND
LACTATING WOMEN DURING CLINICAL
TRIALS.
IT GOES HAND IN HAND WITH THE
EFFORTS FROM THE ICH AND THERE'S
DISCUSSION FROM PHARMA IN TRYING
TO INCLUDE PREGNANT WOMEN.
NOT PRESSURE BUT DESIRE FOR THE
INDUSTRIES TO GET THERE.
JUST WANTED TO SEE WHAT MIGHT BE
ALREADY IN THE WORK WITH RESPECT
TO INDUSTRY PARTNERSHIPS.
>> GO AHEAD, AARON, THANK YOU.
>> I WOULD MAYBE ADDRESS SOME OF
THAT FROM AT LEAST FROM WHAT I'M
SEEING.
THE FOUNDATION OF THE NIH IS
VERY INTERESTED IN BUILDING THAT
OUT AND IN TERM OF THEIR
RECRUITMENT FOR FUNDING FOR THE
PREECLAMPSIA PROJECT IS PART OF
THAT.
FINDING VENUES TO TALK ABOUT THE
IDENTIFIED CHAMPIONS IS GOING TO
BE IMPORTANT.
ONE THING THAT WAS DISCUSSED THE
NATIONAL ACADEMY OF SCIENCES IS
CONDUCTING A STUDY TO ADDRESS
MEDICAL AND LEGAL ISSUES AROUND
THIS AND HAVING THOSE ADDRESSED
IS A KEY COMPONENT TO GETTING
MORE PRIVATE SECTOR ENGAGEMENT.
THE NATIONAL ACADEMY IS A GOOD
VENUE AND THERE'S VARIOUS VENUES
AND THE DEVELOPMENT AND
TRANSLATION IS A GOOD ONE TO
HAVE THE DISCUSSIONS END AND TO
ADD TO YAO'S COMMENTS IN
THINKING HOW TO START THE
DIALOGUES SOONER RATHER THAN
LATER AND I DON'T KNOW IF OTHERS
HAVE ADDITIONAL THOUGHTS
ESPECIALLY THOSE IN THE PRIVATE
SECTOR.
>> HI, TO THE CHAIRS AND TO
EVERYONE FOR THIS IMPORTANT
DISCUSSION.
I HAD A QUESTION THAT'S A LITTLE
BIT DIFFERENT FROM SOME OF THE
TOPICS THAT WERE JUST RAISED SO
HAPPY TO TABLE IT OR TALK ABOUT
IT IN THE CHAT OR A DIFFERENT
TIME OFFLINE.
FOR ME LOOKING GLOBALLY IT SEEMS
FOR ALL THE RECOMMENDATIONS
THERE'S BEEN GOOD ADVANCEMENTS
TALKING ABOUT THE CHARGE OF THE
COUNCIL AND IF IMPLEMENTATION
STEPS HAVE BEEN TAKEN AND SEEMS
THERE'S PROGRESS IN GOOD AREAS.
ONE CONCEPTUAL AREA I STRUGGLE
TO FIND LANGUAGE OR
IMPLEMENTATION PLAN OR MAYBE
COMMENTS DURING THIS MORNING
RELATING TO RECOMMENDATION TWO
AND TO RECOMMENDATION NINE
SIMULATING NEW NOVEL DRUG
DISCOVERY MAYBE THE POINT AT
WHICH DRUG DISCOVERY BECOMES
DRUG ROLLOUT.
WHEN YOU HAVE SOMETHING THAT HAS
GOOD DATA LOU TO MOVE FORWARD TO
DRUG DELIVERY.
I UNDERSTAND THERE'S WELL
ESTABLISHED GUIDELINE FOR DRUG
DELIVERY BY THE NIH IT FEELS
LIKE THERE MAY BE IMPLICIT BIAS
TOWARDS HOLDING BACK THERAPEUTIC
MEASURES AND HOW DO WE THINK
ABOUT CREATING OR INCENTIVIZING
OR RELATING MORE TO THE QUESTION
BY THE PRIOR COMMENTER PUSHING
FORWARD TO STOP OURSELVES FROM
HOLDING BACK EFFECTIVE OR NOVEL
DRUGS.
THAT WAS AN AREA I WAS CURIOUS
ABOUT AND MAYBE THE CHAIRS CAN
LET ME KNOW THIS WILL BE TALKED
ABOUT AT A DIFFERENT TIME AND
I'M HAPPY TO TALK ABOUT IT
LATER.
THANK YOU SO MUCH.
>> I DO THINK SOME WILL BE
TALKED ABOUT IN SESSION 2 AND I
DON'T KNOW IF AARON WANTS TO
TALK TO THE TRANSLATION OF WORK
BECAUSE I THINK IT'S THE CRUX OF
THE CONDITIONS SPECIFIC TO
PREGNANCY AND LACTATION.
THE CONVERSATION AROUND
INCLUSION MUCH PREGNANT AND/OR
LACTATING WOMEN IN CLINICAL
RESEARCH OR THERAPEUTIC NEEDS
THAT ARE THERAPEUTIC NEEDS THAT
RUN IN COMMON AND CONCORDANT
WITH YOUR PREGNANCY OR LACTATING
BEING UNDERTAKEN AT THE
INTERNATIONAL LEVEL.
AARON DO YOU WANT TO TALK ABOUT
THE TRANSLATIONAL SPACE TO THE
CLINICAL TO CARRY THE
THERAPEUTICS FORWARD.
THERE'S PROMISING THERAPEUTICS
AND THERE'S TWO MAJOR INHIBITORY
THINGS.
ONE I TALKED ABOUT THE MEDICAL
LEGAL LIABILITY ISSUES.
YOU KNOW THE PATIENT POPULATION
VERSUS THE COVID CONDITION AND
FOR LACTATION SAFETY WOULD BE IN
PLACE THERE.
GETTING THE MODEL TO HAVE A
BETTER IDEA OF SAFETY AND THE
OTHER GOES TO CLINICAL TRIAL
TRIAL DESIGN AND BIOMARKERS.
YOU HAVE TO GET UP TO ENROLL A
LARGE NUMBER OF PREGNANT
INDIVIDUALS AND THAT INCREASES
THE RISK OF AN ADVERSE EVENT
RELEVANT TO SAFETY AND EFFICACY
AND HAVING BIOMARKERS IN PLACE
FOR RISK STRATIFICATION I THINK
ARE VERY IMPORTANT FOR
COMPLETING THAT TRANSLATIONAL
PIPELINE.
FOCUSSING A LOT ON ALL ASPECTS
OF THE REGULATORY SCIENCE
COMPONENT IS GOING TO BE
CRITICAL TO MAKING IT EASIER FOR
NEW THERAPEUTICS TO GO FROM THE
BENCH TO THE BEDSIDE.
>> IT'S COMPLEX AND THE
RECOMMENDATIONS ARE SCATTERED TO
HOW WE DO THAT AND LOOK
CAREFULLY TO CONTINUE TO ENSURE
WE'RE ABLE TO PROGRESS THROUGH
THE RECOMMENDATIONS AND THEN I
WANT TO APOLOGIZE, I HAVE TO
CLOSE OUT SESSION 1 BUT PUT YOUR
QUESTIONS AND COMMENTS IN THE
CHAT AND I'LL DO MY BEST TO GET
THE RIGHT PERSON TO RESPOND
AND/OR TO MAKE SURE IT'S
CAPTURED FOR PURPOSES OF
UPDATING OUR REPORT FOR
CONGRESS.
EMMA, TO MAKE SURE WE GET TO THE
BREAK BUT BEFORE THAT I WANT TO
THANK OUR COLLEAGUES FROM THE
NATIONAL INSTITUTES OF CHILD
HEALTH AND HUMAN DEVELOPMENT.
IT'S A MONUMENTAL TASK TO WALK
US THROUGH A FLAVOR OF WHAT'S
BEEN HAPPENING FOR THE
RECOMMENDATIONS AND THANK YOU TO
NAHIDA AND CAMILLE AND AARON.
>> THANK YOU SO MUCH AND TO MY
COLLEAGUES.
WE'LL TAKE A BREAK AND RECONVENE
AT 2:15 EASTERN.
WE'LL SEE YOU IN ABOUT 15
MINUTES.
THANKS SO MUCH.
>> I'D LIKE TO WELCOME
EVERYTHING BACK FOR SESSION 2.
>> SESSION 2 GOING TO CENTER
LARGELY ON RECOMMENDATIONS
RELATED TO POLICY AND REGULATORY
ISSUES.
WE LEARNED LEADERSHIP SIGNOFF IS
STILL PENDING AND THERE ARE SOME
SUB RECOMMENDATIONS WE ARE NOT
GOING TO BE ABLE TO DISCUSS
TODAY.
WE'LL LOOK TO COVER OUT TIME IN
OUR IN-PERSON MEETING IN MARCH
TO DISCUSS MORE.
IS THERE ANYTHING ELSE YOU'D
LIKE TO ADD?
>> THAT COVERS IT.
>> I ALSO KNOW FROM THE MEETING
CHAT THERE'S IMPASSIONED
COMMENTS FOLKS WOULD LIKE TO GET
TO.
PLEASE BE PATIENT.
WITH OUR ABILITY TO TRUNCATE
SOME DISCUSSIONS WE MAY BE ABLE
TO CIRCLE BACK AT THE END OF THE
MEETING.
I'D LIKE TO WELCOME KEVIN
PROHASKA AT THE OFFICE OF
CLINICAL POLICY AT FDA AND
DR. LYNNE YAO WITHIN THE OFFICE
OF PEDIATRIC AND MATERNAL
HEALTH.
OVER TO KEVIN.
>> LET ME CLARIFY QUICKLY.
I'M THE ASSOCIATE DIRECTOR OF
CLINICAL POLICY IN THE OFFICE OF
CLINICAL POLICY AND IN THAT ROLE
I ALSO SERVE AS THE SENIOR BIO
ETHICIST FOR ADULT BIO RESEARCH.
MY OFFICE IS THE HUMAN
PROTECTION REGULATIONS
SPECIFICALLY HARMONIZING THE
COMMON RULE AND MY OFFICE HAS
TAKEN THE LEAD IN DEVELOPING
THAT.
SPECIFICALLY, I WAS ASKED TO
TALK TALK TO FDA'S ACTION
RECOMMENDED TO THE FDA SHOULD
HARMONIZE WITH THE COMMON RULE
IN PREGNANT WOMEN AS A
VULNERABLE POPULATION.
FDA HAS ONGOING EFFORT TO
HARMONIZE RULES SPECIFICALLY
21CFR50 THE POTENTIAL FOR HUMAN
SUBJECTS AND THE IRB REGULATIONS
WITH THE COMMON RULE.
COLLECTIVELY, 50 AND 56 HAVE
SUBSTANTIALLY IDENTICAL TO THE
COMMON RULE WITH A FEW EXCEPTION
S AND OVER TIME THE DIFFERENCES
HAVE CHANGED.
HISTORICALLY THE COMMON RULE ARE
ALIGN WITH THE INCLUSION OF
PREGNANT WOMEN AS AN EXAMPLE OF
A POPULATION THAT MAY BE
VULNERABLE AND THEY UPDATED THE
COMMON RULE IN 2018 THE GOOD
NEWS IN 2022 THEY HARMONIZED
CERTAIN PROVISIONS OF THE
REGULATIONS 50, AND 56 TO
INCLUDE PREGNANT WOMEN AS
VULNERABLE POPULATION TO
HARMONIZE WITH THE 2018 COMMON
RULE TO THE EXTENT PRACTICABLE
IN CONSISTENT WITH OUR STATUTORY
PROVISIONS.
I BELIEVE YOU'VE BEEN PROVIDED A
LINK TO THE PROPOSED RULES AND
WILL TRY TO ANSWER QUESTIONS YOU
HAVE ABOUT IT BUT THE PUBLIC
COMMENTS FOR THOSE ARE ACTIVELY
BEING REVIEWED THEY'RE ALSO
AVAILABLE FOR REVIEW IN THE FDA
DOCKET AND THE REMOVAL OF
PREGNANT WOMEN FROM THE LIST HAS
BEEN GENERALLY FAVORABLE AND
PREGNANT WOMEN WILL BE REMOVED
FROM THE LIST WHERE CITED.
>> WILL THIS GO TO RESEARCH
DEFINE AND UNDEFINED.
>> I THINK YOU'RE REFERRING TO A
REGULATORY REQUIREMENT FOUND IN
THE SUBPAR B ADDITIONAL PROTECTS
FOR PREGNANT WOMEN/FETUSES.
THAT REGULATION, FDA DID NOT
ADOPT SO MY OFFICE IS NOT
INVOLVED WITH CHANGING OR
LOOKING AT THAT.
>> I FOUND SOMETHING ON THE FDA
WEBSITE SAYING THOUGH IT DIDN'T
TOTALLY ADOPT IT IT FOLLOWED IT.
IS THAT NOT THE CASE?
>> I BELIEF YOUR REFERRING TO A
DRAFT GUIDANCE THAT MAKES
REFERENCES TO SUBPART B THAT IS
DRAFTED RIGHT NOW AND IS NOT AN
FDA REGULATION.
>> UNDERSTOOD.
OKAY.
SO FOR THE MOMENT THE DRAFT
GUIDANCE SAID YOU FOLLOW THE
SAME POLICY AS THE CFR FOR NIH
BUT UNDER REREVISION 2018.
>> I BELIEVE IT'S WRITTEN AS A
RECOMMENDATION AND GUIDE THAT
MUST BE FOLLOWED.
>> IT'S NOT THE ONLY TIME PEOPLE
HAVE SAID IT'S NOT DRAFT
GUIDANCE BECAUSE IT DRAGS OUT.
>> FAIR ENOUGH.
AS SOON AS IT'S FINALIZED THE
DRAFT GUIDANCE WILL BE REMOVED.
>> THANK YOU.
ANY OTHER CLARIFYING QUESTIONS
FOR DR. PROHASKA.
SEEING NONE --
>> SORRY.
I DON'T KNOW IF YOU CAN SAY
ANYTHING ABOUT THE TIME LINE FOR
THE RELEASE OF THE FDA
HARMONIZED REGULATION?
>> THANK YOU FOR THE QUESTION.
AS YOU KNOW WE HAVE STRICT
REQUIREMENTS TO WHAT WE CAN SAY
SO I DON'T HAVE ENOUGH DATA ON
THAT.
>> I UNDERSTAND, THANK YOU.
>> SEEING NO ADDITIONAL
QUESTIONS, WE'LL TURN IT OVER TO
DR. YAO.
>> I'LL SHARE MY SCREEN AND
HOPEFULLY THIS WILL WORK.
ALL RIGHT.
I'M HOPING -- ARE YOU SEEING MY
SCREEN?
>> GOOD.
>> IT IS.
>> I'M THRILLED TO BE HERE AND
VERY MUCH APPRECIATE THE
OPPORTUNITY TO PRESENT SOME FDA
UPDATES RELATED TO
RECOMMENDATION 10 WHICH I
UNDERSTOOD WAS MY CHARGE FOR
THIS MEETING.
SO AS A BACKGROUND I FLOW ALL OF
YOU ON THE COMMITTEE KNOW THE
RECOMMENDATIONS BACKWARDS AND
FORWARDS.
RECOMMENDATION 10 HAD A LOT OF
SUB PARTS.
WHAT THE GIFT AND IMPORTANT PART
OF RECOMMENDATION 10 WAS TO
IMPLEMENT A PROACTIVE APPROACH
TO PROTOCOL DEVELOPMENT AND
STUDY DESIGN TO INCLUDE PREGNANT
AND LACTATING WOMEN IN CLINICAL
RESEARCH.
IT INCLUDED A LOT OF TEXT UNDER
EACH RECOMMENDATION BUT EACH OF
THESE SUB RECOMMENDATIONS THAT
INVESTIGATIONS AND SPONSORS MUST
JUSTIFY EXCLUSION AND STUDY
DESIGN, B, THE STUDIES ARE
DESIGN TO CAPTURE THE TIME
DEPENDENCY OF PHYSIOLOGICALLY
CHANGES IN PREGNANCY AND
LACTATION WOMEN AND DEVELOPING A
SYSTEMATIC PLAN HOW TO GET DATA
IN PREGNANT AND LACTATING WOMEN
IN A TIMELY PASSION TO INCLUDE
SAFETY AND THE NOTION OF A
PRGLAC STUDY PLAN AND DEVELOP
GUIDANCE FOR IRBs AND
INVESTIGATORS ABOUT INCLUDING
PREGNANT AND LACTATING
INDIVIDUALS IN RESEARCH AND IF
AN INDIVIDUAL BECOMES PREGNANT
IN THE STUDY, TO GIVE GUIDANCE
AND CREATE A PLAN THAT WOULD
ENCOURAGE PATIENTS TO CONTINUE,
TO CAPTURE IMPORTANT
OPPORTUNISTIC INFORMATION IN THE
PATIENTS WHO DO BECOME PREGNANT
AND INCLUDE PREGNANCY OUTCOME
INFORMATION.
THE REST OF MY TALK WILL BE
ABOUT WHAT FDA'S DONE AND MOST
OF HOW FDA COMMUNICATES AND THE
GUIDANCE ARE FDA'S THINKING
AND --
[NO AUDIO]
WE'RE WORKING TO REVISE ACTIVELY
RIGHT NOW.
SOME GUIDANCES ARE IMPORTANT TO
POINT OUT BECAUSE THEY ADDRESS
MANY OF THE RECOMMENDATIONS AND
SUB RECOMMENDATIONS UNDER 10.
THE FIRST THIS HAD GOTTEN AT THE
TIME THE RECOMMENDATIONS WERE
BEING MADE AND THERE'S A
REFERENCE TO THIS IN THE ACTUAL
PRGLAC RECOMMENDATIONS.
WE DID PUBLISH IN 2018 GUIDANCE
ON INCLUSION OF PREGNANT WOMEN
IN CLINICAL TRIALS AND DISCUSSED
REASONS AND JUSTIFICATIONS FOR
REASONS FOR PREGNANT INDIVIDUALS
IN CLINICAL TRIALS.
THAT ADDRESSES RECOMMENDATION
10D.
HOWEVER, IT KIND OF STOPS SHORT
ABOUT RECOMMENDING THAT DRUG
DEVELOPERS OR RECOMMENDATION TO
JUSTIFY COLLUSION.
THAT WOULD BE
[AUDIO DIGITIZING]
DESCRIBES HOW TO COLLECT DATA
DURING PREGNANCY IF A PATIENT
WERE TO BECOME PREGNANT AND ALSO
HOW TO COLLECT PREG NOON SI AS
PART OF A CLINICAL TRIAL.
THAT'S BOTH 10B AND 10E AND
FINALLY A WHOLE SECTION ON
ISSUES RELATED TO DISCUSSION OF
WHEN PATIENTS BECOME PREGNANT
DURING THE TRIAL.
THE ONE THING IT DOESN'T INCLUDE
A DISCUSSION FOR RECOMMENDATION
OF OPPORTUNISTIC DATA BUT TALKS
ABOUT UB BLINDING AND COLLECTING
PREGNANCY OUTCOME.
AND THIS GUIDANCE IS UNDERGOING
REVIEW AND REVISION.
>> DR. YAO WE'RE HAVING TROUBLE
WITH YOU CUTTING IN AND OUT AND
IF YOU WOULDN'T REMIND REPEATING
WHERE THE GUIDANCE FALLS SHORT.
>> MY APOLOGIES.
LET ME QUICKLY CHECK MY AUDIO.
I HOPE THAT HELPS.
THE GUIDANCE FALLS SHORT IN ITEM
RECOMMENDATION 10A TO
SPECIFICALLY JUSTIFY EXCLUSION
THE GUIDANCE TALKS ABOUT THE
IMPORTANCE OF JUSTIFYING
INCLUSION BUT REALLY DOESN'T
CALL OUT A RECOMMENDATION TO
JUSTIFY EXCLUSION.
THAT'S 10A.
THE OTHER PLACE WHERE IT DOESN'T
COMPLETELY ADDRESS IS ITEM 10E
WHICH WAS THE IDEA YOU COULD
COLLECT OPPORTUNISTIC P.K. OR
CLINICAL DATA IF A PATIENT WERE
TO BECOME PREGNANT DURING THE
CLINICAL TRIAL.
WE DO TALK ABOUT UNBLINDING AND
TALK ABOUT COLLECTING PATIENT
OUTCOMES BUT WE'RE NOT TALKING
ABOUT COLLECTING OPPORTUNISTIC
INFORMATION.
I WANTED TO CLARIFY THIS
PARTICULAR GUIDANCE DOESN'T
SPEAK TO THOSE TWO ITEMS.
WAS THAT HELPFUL AND I HOPE
PEOPLE CAN HEAR ME BETTER NOW?
>> THAT SEEMS TO BE BETTER.
>> WONDERFUL.
MOVING ON.
THE NEXT GUIDANCE I WANT TO TALK
ABOUT AND I TAKE YOUR POINT
HERE, THIS GUIDANCE IS
ORIGINALLY PUBLISHED IN 2004P.K.
AND PREGNANCY.
HOW DO YOU COLLECT P.K. DATA IB
PREGNANCY.
WE'RE ACTIVELY UNDER REVIEWING
THE GUIDANCE AND UNDERGOING
SUBSTANTIAL REVISION.
AGAIN AS KEVIN POINTED OUT,
WE'RE WORKING HARD ON THE
GUIDANCES.
THIS GUIDANCE DOES ADDRESS 10B
AND IT'S ABOUT THE CAPTURING THE
PHYSIOLOGIC CHANGES DURING
PREGNANCY AND TRYING TO CAPTURE
P.K. DATA PREPREGNANCY DURING
ALL THREE TRIMESTERS AND IN THE
POSTPARTUM PERIOD AND IT SPEAKS
TO THAT RECOMMENDATION.
MANY HAVE HEARD ABOUT THIS
GUIDANCE AND COMING OUT IN 2019
AND I'VE BEEN ON THE WORK GROUP
FOR THIS PARTICULAR GUIDANCE.
THIS TALKS ABOUT -- CAN YOU
STILL HEAR ME?
MY MICROPHONE IS CHANGING ON ME
AND I DON'T KNOW WHY.
>> IT DOES SOUND LIKE YOU
SWITCHED OVER TO A DIFFERENT
MICROPHONE TO US.
>> LET ME TRY THIS.
SO THE NEXT ISSUE RELATES TO
PHYSIOLOGIC CHANGES AND THIS
GIVES SPECIFIC RECOMMENDATIONS
ABOUT THE NEED TO COLLECT
LACTATION INFORMATION
POTENTIALLY AT ALL STAGES OF
LACTATION.
IT ALSO DESCRIBES SPECIFIC
SITUATIONS IN WHICH LACTATION IS
CONSIDERED WHICH I THINK DOES
SPEAK TO RECOMMENDATION 10D.
THE NEXT GUIDANCE IS THE POST
APPROVAL SAFETY GUIDANCE.
A REALLY IMPORTANT GUIDANCE I
THINK GIVES US DEVELOPERS A GOOD
IDEA ABOUT WHAT FDA'S THINKING
ABOUT AND WHAT TYPES OF
PREGNANCY STUDIES IN ORDER TO
COLLECT PREGNANCY SAFETY
INFORMATION SHOULD BE CONSIDERED
AND SPECIFICALLY DISCUSSES THE
TYPES OF STUDIES THAT CAN BE
CONSIDERED TO COLLECT SAFETY
INFORMATION IN THE POST
MARKETING SETTING.
10C TALKS ABOUT CPK AND THIS
PARTIALLY ADDRESSES 10C AND THE
IT FDAs INTEREST IN PDUFA VII TO
UNDERSTAND SAFETY WHEN DRUGS ARE
USED DURING PREGNANCY.
THAT PDUFA FRAMEWORK WILL REALLY
I HOPE IMPROVE ON GETTING TIMELY
INFORMATION BACK ON THE SAFETY
OF THE DRUGS AND BIOLOGICAL
PROHIBITS OF VACCINES WHEN USED
DURING PREGNANCY.
THIS IS JUST A SUMMARY TABLE
BECAUSE I KNOW IT WAS A LITTLE
BIT WORDY BUT IF YOU LOOK AT
EACH OF THE RECOMMENDATIONS, 10A
THROUGH 10E DO FDA GUIDANCES AND
FRAMEWORKS BEGUN TO ADDRESS
THESE?
YOU CAN SEE IN ALL CASES FOR 10A
THE GUIDANCES FO SINCE 2018
ADDRESS THESE RECOMMENDATIONS.
THE ONE POINT I'LL MAKE IS WE
TALK ABOUT IN OUR ETHICAL
CONSIDERATIONS OR SCIENTIFIC AND
ETHICAL CONSIDERATION FOR
INCLUSION OF PREGNANT WOMEN IN
CLINICAL STUDIES THAT IT JUST
NOT DESCRIBE THE JUSTIFICATION
FOR EXCLUSION BUT REASONS FOR
INCLUSION.
[AUDIO DIGITIZING]
>> DR. YAO WE HAVE LOST YOU
AGAIN AS YOU WERE GETTING INTO
PART 2.
>> I'M SORRY.
I CHANGED MY MICROPHONE I HOPE
THAT HELPS.
SO IN TERMS OF THE COMMENTS I
HAVE FOR THE PDUFA VII FRAMEWORK
FOCUSES ON SAFETY AND 10D WAS TO
GUIDANCE AND INVESTIGATORS.
I THINK ALL THE GUIDANCES WE
PUBLISH IS FOR GUIDANCE FOR
INDUSTRY AND CAN BE USED FOR IRB
AND ACADEMIC INVESTIGATORS.
AND FOR 10E RECOMMENDATIONS
DON'T CURRENTLY TALK ABOUT
INCLUSION OF RECOMMENDATIONS FOR
OPPORTUNITIES TO COLLECTION OF
SAFETY AND P.A. DATA.
IN SUMMARY, I DO QUANTITY TO
POINT OUT THE GAPS.
THESE GAPS AS I MENTIONED IN 10A
AND I THOUGHT IT WAS 10C BUT 10A
TALKS ABOUT THE FDA REQUIRING
DRUG DEVELOPERS TO PROVIDE A
PRGLAC STUDY PLAN FOR ASSESSMENT
DURING DRUG DEVELOPMENT AND
REPEATED IN 10C.
THE ONLY THING I WANT TO POINT
OUT IS CURRENTLY NO EXPLICIT
STATUTORY OR REGULATORY
REQUIREMENT THAT SPONSORS MUST
SUBMIT A PRGLAC STUDY PLAN TO
FDA.
THE OTHER POINT I'D LIKE TO MAKE
AND WOULD LIKE TO HEAR ON THE
DISCUSSION MOVING FORWARD THIS
IS ONE AGENCY WITHIN GOVERNMENT.
I KNOW THE GOAL FOR THE MEETING
WAS TO TALK ABOUT WHAT
GOVERNMENTAL AGENCIES HAVE DONE
TO UPDATE ON THESE
RECOMMENDATIONS BUT IT BE REALLY
GREAT TO HEAR IF POSSIBLE WHAT'S
GOING ON IN ACADEMIA AND
INDUSTRY AND CERTAINLY IF THERE
ARE OTHER GOVERNMENTAL AGENCIES
RECOMMENDATIONS FOR PULLING
THOSE AGENCIES IN TO HELP A MORE
FULL UNDERSTANDING OF WHAT'S
GOING ON IN THE SPACE.
I THINK THAT WOULD BE SOMETHING
THE COMMITTEE SHOULD STRONGLY
CONSIDER.
AND WITH THAT I WILL STOP
SHARING AND THANK YOU FOR YOUR
ATTENTION AND AGAIN MY APOLOGIES
FOR AUDIO DIFFICULTIES.
>> THAT WAS A GREAT OVERVIEW,
LYNNE, THANK YOU.
BEFORE WE GET IN THE ACTUAL
DISCUSSION I'LL OPEN FOR ANY
CLARIFYING QUESTIONS TO DR. YAO
ABOUT HER PRESENTATION?
SHARON.
>> MY QUESTION WAS IS THERE A
REGULATORY NEED FOR THESE
STUDIES OR REGULATORY COMMITMENT
FROM THE PHARMA SIDE.
THE DATA FOR THEM FOR LACK OF A
BETTER WORD WILL THEN BECOME
PART OF THE PACKAGE INSERT?
WE FIND THE ISSUE ALL THE TIME
AND THE DRUG IS LICENSED IN
ADULTS, THERE'S NO DATA IN
PREGNANCY AND WE'RE DOING THE
STUDY DURING PREGNANCY AND THE
QUESTION IS, IS IT A REGULATORY
OR NOT A REGULATORY STUDY OR
PHASE 4 AND WHAT'S THE
REGULATORY COMMITMENT FROM THE
NETWORK TO DEVELOP THIS STUDY,
ETMF, THE WHOLE NINE YARDS.
>> DR. YAO, IF YOU ARE SPEAKING,
YOU ARE ON MUTE.
>> WE MAY BE EXPERIENCING SOME
TECHNICAL DIFFICULTIES, SHARON,
HOLD ON TO THAT.
>> FOR ME IT'S THAT BIG
PICTURE.
THESE ARE AN FDA REQUIREMENT ARE
THEY REGULATORY OR PHASE 4
REQUIREMENT.
WE NEED TO UNDERSTAND AS PRGLAC
NETWORK HOW'S DO WE APPROACH
PHARMA TO DO THESE STUDIES AND
WHAT'S THE COMMITMENT ON OUR
SIDE ON THE NETWORK SIDE AND
WHEN WE WRITE THE STUDIES AND
WHAT'S THE AUDIT TRAIL TO SUBMIT
THE DATA.
IT'S A BIG PICTURE FOR ME AND
CERTAINLY NOT CLEAR.
>> I'M GOING SEE IF WE HAVE
DR. YAO BEFORE WE CONTINUE WITH
ANY CLARIFYING QUESTIONS.
IF WE DON'T, ALTA, IF YOU HAVE A
CLARIFYING QUESTION IN THE CHAT
HOLD ON UNTIL DR. LYNNE COME
BACK.
>> LEYLA ARE YOU ON?
>> I'M FROM THE DIVISION OF
PEDIATRICS AND MATERNAL HEALTH.
THE REQUIREMENTS ARE ISSUED AT
THE TIME OF NDA OR BLA APPROVAL
TO INDUSTRY AND THERE ARE
DEFINITE TIME LINES INCLUDED AS
PART OF THOSE PMRs AND PUBLICLY
AVAILABLE INFORMATION.
WHEN A NEW DRUG IS APPROVED,
THERE'S AN APPROVAL LETTER AND
ALONG WITH THAT APPROVAL LETTER
THERE'S LANGUAGE THAT BASICALLY
OUTLINES THE PARAMETERS OF THE
PHASE 4 STUDIES ISSUED WITH THE
MILESTONE DATES WITH COMPLETION
OF THE STUDIES.
I DON'T KNOW IF THAT ANSWERS THE
QUESTION THAT WAS ASKED.
>> IT'S HELPFUL BUT I GUESS THE
REAL QUESTION IS, IS THAT EVERY
NEW DRUG NOW COMING THROUGH IS
GOING TO HAVE THIS REQUIREMENT
OR DO MOST THE COMPANIES GET
THIS OPT-OUT, WE CAN'T DO IT
DURING PREGNANCY.
THERE'S NO OBLIGATION AND THEN
IT'S INVESTIGATOR INITIATED IF
IT EVER GOES THROUGH?
>> THAT'S A GOOD QUESTION.
I THINK THAT SPEAKS TO A PRGLAC
RECOMMENDATION FOR THE NEED FOR
SYSTEMATIC CONSIDERATION OF WHAT
STUDIES WILL BE NEEDED TO
ADDRESS THESE DATA GAPS AND THE
RECOMMENDATION FOR THE NEED FOR
PREGNANCY AND LACTATION STUDY
PLANS BECAUSE THE CURRENT
REGULATORY ENVIRONMENT IS THAT
THERE ARE REQUIREMENTS IN THE
SYSTEMATIC WAY.
THERE'S VARIATION ACROSS REVIEW
DIVISIONS AND SO THAT IS
DEFINITELY A DATA GAP.
THANKS FOR POINTING THAT OUT.
>> THANK YOU.
THERE'S A CLARIFICATION
QUESTION.
>> NOT SURE IT'S CLARIFYING AND
DON'T MEAN IT TO BE AGGRESSIVE.
I SPEAK AS SOMEONE AT THE FDA SO
I'M FOND OF THE AGENCY.
WE'RE TALKING ABOUT THE
INCLUSION OF WOMEN DURING TRIALS
AND THE SECOND IS IN PHASE IV
POST APPROVAL POP FOR THE POST
APPROVAL TO DETERMINE IF IT
HELPS AT ALL THE QUESTION IS FOR
ALL POST-APPROVAL PHASE IV
REQUIREMENTS, WHAT PERCENTAGE OF
THOSE ARE EVER COMPLETED AND OF
THOSE HOW MANY ARE COMPLETED ON
TIME AND FOR THE ONES THAT
AREN'T, WHAT KIND OF
DISCIPLINARY MEASURES HAVE EVER
BEEN TAKEN FOR THE DRUG'S
APPROVAL FOR BLACK BOX WARNINGS
OR ANYTHING LIKE THAT?
I'M TRYING TO FIGURE OUT IF IT'S
AN EFFECTIVE STRATEGY FOR GET
THIS INFORMATION OPPOSED TO
FOCUSSING INSTEAD ON THE
PRE-APPROVAL MOMENT WHEN THE
INDUSTRY HAS THE STRONGEST
INCENTIVE TO GET IT OUT TO THE
MARKET TO MAKE MONEY.
>> LYNNE, ARE YOU BACK ON?
>> I THINK THE WEATHER IS
PLAYING AND I MOVED LOCATIONS IN
MY HOME IN ORDER TO HOPEFULLY
IMPROVE MY SIGNAL.
LET ME SAY BOTH OF THOSE
QUESTIONS I THINK WHAT SHARON
POSES ARE AT THE HEART OF WHAT
WE'RE STRUGGLING WITH RIGHT NOW.
WE JUST DID A REVIEW AS PART OF
THE FRAMEWORK MEETING AND WE
UNDERTOOK A REVIEW OF SORT OF
HOW MANY PREGNANCY REGISTRIES
WERE CONDUCTED AND HOW MANY WERE
SUCCESSFULLY FULFILLED SORT OF
BY DIFFERENT THERAPEUTIC AREAS
AND BY AND LARGE THE REGISTRY
STUDIES OR THE DATA OR
POST-MARKETING REQUIREMENT
STUDIES THAT WERE COMPLETED MOST
SUCCESSFULLY ALL UTILIZE A
DISEASE-BASED TYPE OF REGISTRY.
SO FOR THE ANTI-EPILEPTICS AND
FOR THE ANTI RETROVIRAL HAD THE
HIGHEST NUMBER AND I DON'T
REMEMBER THE DRUGS APPROVED
COMPARED TO OTHER REGISTRIES OR
OTHER PMRs WERE REQUIRED AND
FROM THOSE HOW MANY WERE
FULFILLED AND HOW MANY HAD
LABELLING.
IT'S A FAIR QUESTION.
WE ANSWERED PART OF THAT WITH
THE DATA REVIEW WE DID FOR THAT
MEETING AND WE CAN PROVIDE
PROBABLY SLIDES FOR THE MEETING
FOUR AND FOR THE COMMITTEE.
THE OTHER -- SO I THINK YOU'RE
RIGHT, THE WHOLE REASON FOR THE
PDUFA VII FRAMEWORK IS TRY TO
IMPROVE THE SETTING AND YOU MAKE
A POINT EVEN IF WE CAN GET DATA
ARE WE EVER GOING TO GET IT IN A
TIMELY WAY AND ARE WE GOING TO
GET INFORMATION THAT SUPPORTS A
CHANGE TO THE LABEL I LABELLINGE
NEED TO FOCUS ON PREMARKET.
I THINK IT'S GOT TO BE A
COMBINATION OF BOTH.
I DON'T THINK ULTIMATELY WE'RE
EVER GOING TO GET ENOUGH
PREMARKETING AND HAS TO BE A
COMBINATION OF BOTH AND I THINK
WE CAN GREATLY IMPROVE WHAT
WE'RE DOING ON THE
POST-MARKETING SIDE TO GET MORE
INFORMATION MORE TIMELY AND GET
THE SOURCES WE HAVE AND
COLLECTIVELY COMMIT TO GETTING
THAT INFORMATION IN A REGISTRY
WHICH WE KNOW GIVES THE BEST
INFORMATION WE CAN GET TO WORK
TOGETHER TO COLLECT THAT
INFORMATION IN A MORE TIMELY
FASHION.
IN MY VIEW IT'S GOT TO BE BOTH.
WE HAVE TO DO BETTER ON THE
PRE-MARKET AND ON THE
POST-MARKET.
I DON'T THINK IT'S GOING TO BE
ONE OR THE OTHER.
TO SHARON, LEYLA ANSWER THE
QUESTION, I HOPE, THAT YOU WERE
ASKING.
I'M STOP THERE.
>> WE WORKED TO MAKE SURE
PREGNANT PEOPLE WERE IN THE
DIVERSITY ACTION PLAN IN THE
2023 OMNIBUS AND WONDERING IF
YOU'VE HAD DISCUSSIONS AND
WONDERING IF THERE'LL BE
ANYTHING GOOD TO COME OUT OF
THAT OR SHOULD HAVE TRIED
ANYTHING OF SOMETHING ELSE AND
YOUR FEEDBACK AND HOW THAT MIGHT
HELP US OR NOT IN THE SPACE.
>> BECKY, THANK YOU AND THANK
YOU FOR YOUR EFFORTS THROUGH
SMFM.
A STRONG ALLIANCE THERE AND
PUSHING FORWARD FOR THINGS WE
THINK ARE IMPORTANT AND WHERE WE
CAN GET THE MENTION OF WHAT TO
DO WITH PREGNANT INDIVIDUALS
DESERVE TO BE INCLUDED IN
RESEARCH AND COLLECT THE
INFORMATION THAT SUPPORTS THE
SAFE AND EFFECTIVE USE INCLUDING
DOSING.
ANY KINDS OF THOSE EFFORTS I
THINK IN ANY KIND OF GUIDANCE
WILL BE HELPFUL TO FDA.
THAT'S MY PERSONAL OPINION.
THE OTHER THING I'LL SAY IS THAT
LET ME BE CLEAR ALL THE GUIDANCE
I'LL BE MENTIONED ARE NOT FINAL
YET.
THERE IS THE OPPORTUNITY TO MAKE
CHANGES TO GUIDANCES WE HOPE
WILL BE MORE REFLECTIVE OF THE
RECOMMENDATIONS OF PRGLAC IF
THAT'S CODE ENOUGH FOR
EVERYBODY.
HOPEFULLY THAT HOPES TO ANSWER.
>> THANK YOU, CHRISTINA.
>> THIS IS NOT A QUESTION FOR
DR. YAO BUT A REMINDER TO THE
WORKING GROUP, SO ALL THIS
CONVERSATION IS IMPORTANT
COUGHINGS BUT IT -- CONVERSATION
BUT DUPLICATING WHAT HAPPENED IN
THE ORIGINAL PRGLAC WHICH LED TO
THE RECOMMENDATIONS.
WHAT WE'RE SUPPOSED TO FOCUS ON
IS BASED ON THE RECOMMENDATIONS
MADE AND SUBRECOMMENDATIONS
THERE.
HOW ARE WE PROGRESSING TO DATE
AND WHAT ADDITIONAL WORK MAY
NEED TO BE DONE TO BE ABLE TO
ADVANCE THESE PIECES BECAUSE AS
YOU SAW WITH WHAT WAS PROVIDED
FOR THE RECOMMENDATIONS TODAY
THERE'S A MIX OF PRE-MARKET
RECOMMENDATIONS AND POST-MARKET
RECOMMENDATIONS TO GENERATE
DIFFERENT TYPES OF INFORMATION
THAT WILL BETTER INFORM
LABELLING FOR USE IN PREGNANT
AND LACTATING POPULATIONS.
THINK ABOUT THAT AS WE'RE
FURTHER SHAPING THIS DISCUSSION
ON HOW BEST TO SHAPE A REPORT
FOR CONGRESS.
>> THANK YOU, CHRISTINA.
RACHEL, HOLD YOUR QUESTION AND
I'LL ASK EMMA TO PULL UP OUR
SLIDES FOR DISCUSSION TODAY SO
WE HAVE THAT FRAMEWORK SET UP.
WE KNOW WHY WE WANT THE
DIRECTION OF THE CONVERSATION TO
GO.
AGAIN, RECOMMENDATION 1A
INCLUDES DISCUSSING AND
INTEGRATING PREGNANT AND
LACTATING WOMEN IN THE RESEARCH
AGENDA.
WE 1A WAS ACCOMPLISHED.
IN 2019 THE COMMON RULE WAS
UPDATED AND THIS COULD BE
CONSIDERED COMPLETE AND WHAT
WE'LL DISCUSS AROUND
RECOMMENDATION 1 IS 1B.
HERE WE'RE TALKING ABOUT
RECOMMENDATIONS THAT HAVE TO DO
WITH ARE REMOVING REGULATORY
BARRIERS TO RESEARCH.
AND BECAUSE WE ARE WAITING ON
THE WRITTEN FROM UPDATE FROM
OHRP WE WILL NOT BE DISCUSSING
THIS RECOMMENDATION TODAY.
AGAIN, AS WITH RECOMMENDATION 4,
BECAUSE WE FEEL ADDITIONAL
ACTION NEEDS TO BE MOVED FORWARD
NEITHER WILL BE DISCUSSED TODAY
BUT ANY COMMENTS YOU HAVE CAN BE
PROVIDED WHEN WE SEND OUT THE
PO
POST-MEETING SUMMARY AND THE
LAST SLIDE IS WHERE WE'LL SPEND
OUR TIME TODAY AS IT RELATES TO
RECOMMENDATION 10.
THIS SPECIFICALLY IMPLEMENTATION
OF A PROACTIVE APPROACH TO STUDY
DESIGN AS CAN BE READ OFF THE
SLIDE AS WELL.
SO I'M GOING TO TAKE US BACK TO
RECOMMENDATION 1 AND SEE IF WE
CAN'T GET THE CONVERSATION GOING
ABOUT VIEWS ON PROGRESS AND
ADDITIONAL ACTION THAT NEEDS TO
BE CALLED OUT IN OUR RECORD.
THE IMPACT OF 1A AND MOVING
TOWARDS 1B AND A CHANGE OF
TRIALS IN RESEARCH POPULATIONS
AND IF YOU'RE SEEING DIFFERENT
APPROACH TO IRBs OR IF IN OUR
REPORT WE NEED TO RECOMMEND
ADDITIONAL ACTIONS TO GET US TO
WHERE WE NEED TO GO AND THE
INTENT WAS OF THE ORIGINAL TASK
FORCE BY MOVING THE POPULATION
THIS WOULD MOVE US DOWN THE PATH
OF SEEING MORE OF THIS RESEARCH
BEING STARTING IN THE FIRST
PLACE.
>> RICHEL, THIS IS ALISON, THANK
YOU VERY MUCH FOR THE QUESTION.
INDs THAT INCLUDE TRIALS IN
PREGNANT WOMEN
>> THERE'S A FAIR BIT OF OVERLAP
BEYOND EXTENDING BEYOND WITH
RESPECT TO 1A AND 1B AND IF WE
HAVE SUMMARY COMMENTS FROM FDA
I'D WELCOME THEM.
>> THIS IS KEVIN.
I'LL TRY TO RESPOND THOUGH I
DON'T HAVE THE DATA.
ACTUALLY, I'M NOT AWARE OF ANY
DATA THAT WILL SAY WHETHER THIS
RESEARCH WILL BE MORE
FORTHCOMING IN THIS SPACE AND
HOPE IT WILL BE.
I HEARD ANECDOTALLY FROM IRB
MEMBERS IT WILL HAVE AN IMPACT
ON THEIR DELIBERATIONS AND AS
SUCH MOVING PREGNANT WOMEN AS A
VULNERABLE POPULATION WILL ALLOW
MORE RESEARCH GOING FORWARD.
WHETHER THAT'S TRANSLATED TO
MORE PROTOCOLS BE SUBMITTED TO
THE FDA IN THE SPACE I'M AFRAID
I DON'T HAVE AN ANSWER TO THAT
QUESTION.
>> ACROSS THE IMPLEMENTATION
WORKING PLANS SPECIFIC COMMENTS
OF NOT ONLY INCLUDING PREGNANT
AND LACTATING INDIVIDUALS IN THE
INCLUSION OF RESEARCH BUT ALSO
INCLUDING THEM INTO THE
DISCUSSION OF HOW RESEARCH IS
DESIGN OR CONDUCTED.
AND SPECIFICALLY THINKING OF
COMMUNITY ADVISORY BOARDS OR
ADVOCACY GROUPS AND I WASN'T
SURE IF THAT FITS INTO
RECOMMENDATION 1 OR FOUND IN
OTHER PLACES BUT SEEMED
WORTHWHILE FOR US RAISING
BROADLY.
I FEEL IT'S WORTH ALLUDING TO AT
TIMES BUT WE SHOULD HAVE EFFORTS
TO ENCOURAGE THAT AND AT TIMES
IT'S BEEN ALLUDED TO I'M NOT
SURE ABOUT PROGRESS MADE IN THAT
RENA.
THANK YOU.
-- THAT ARENA.
>> THIS IS ALISON AND I WANT TO
EC ECHO WHAT A FANTASTIC POINT
AND QUESTION THAT IS FROM YOU
AND WHAT IS GOING PART AT
COMANCHE WHERE I'M THE HERE AT
THE STUDY AND WE HAVE A
RESPONSIBILITY AND THAT'S PART
IS TO INCLUDE THE VOICE OF THE
PATIENT ADVOCATES FROM THE VERY
BEGINNING OPPOSED TO GOING FROM
LICENSURE AND GOING FROM THE
PROTOCOL ITSELF.
>> IF THERE'S ADDITIONAL
THOUGHTS BEFORE WE MOVE TO
RECOMMENDATION 10 WHERE IS WHERE
THE BULK OF OUR CONVERSATION
WILL BE.
WE'VE GOT FIVE SUB
RECOMMENDATIONS AND THERE'S A
NUMBER BENEATH THERE BUT I'LL
START BY OPENING IT UP TO
COMMENTS, ADDITIONAL QUESTIONS
THAT WE HAVE AROUND THESE SUB
RECOMMENDATIONS OR POINTS OF
DISCUSSION.
>> THERE'S A QUESTION OF HOW ARE
WE DEALING WITH THESE ELEMENTS?
I CAN SAY THAT WE ESTABLISHED
THIS BUT HAS THAT MOVED THE
NEEDLE AT ALL AND THE COMMENT IN
THE CHAT MAY BE SOMETHING WE
SHOULD CONSIDER WHICH IS TO SEE
SINCE THE PRGLAC RECOMMENDATIONS
HAVE BEEN ISSUED HOW MANY
PREGNANT INDIVIDUALS HAVE BEEN
ENROLLED IN CLINICAL TRIALS.
THOSE ARE THE KINDS OF THINGS
THAT MAY BE USEFUL TO DO AS A
RECOMMENDATION TO MAYBE ASSESS
IN SOME WAY GUIDANCE BEING
ISSUED FOR EXAMPLE AND IT'S
BASED ON CHRISTINA'S COMMENT.
>> AGAIN WE'RE HEARING SEVERAL
COMMENTS NOW ABOUT MOVING BEYOND
PROGRESS AND LOOKING AT IMPACT
OR UNDERSTANDING IMPACT AND
MAKING SURE THAT WE EMPHASIZE
THE IMPORTANCE OF GOING BEYOND
JUST NOTICING WHERE THE PROGRESS
IS.
IT SOUNDS LIKE THERE MAY BE
LITERATURE WHETHER THE NEEDLE
WOULD MOVE WITH THE COMMON RULE
IN TERM OF WHAT WE KNOW BUT
FINDING OUT WOULD BE HELPFUL.
I JUST WANT TO EMPHASIZE WE'VE
BEEN CIRCLING AROUND THIS AND WE
TALKED ABOUT IT BUT I THINK THE
IMPORTANCE OF 10A HAS NOT BEEN
SUFFICIENTLY ADDRESSED AND IF
THERE ARE OPPORTUNITIES NOW AS
WE HEARD BECAUSE SO MUCH OF THE
GUIDANCE FROM FDA IS IN DRAFT
FORM TO TRY TO GET THIS PIECE OF
REQUIRING JUSTIFICATION OF
EXCLUSION INCLUDED IN GOODANCE
WHICH FROM FDA HAS PRACTICAL
GUIDANCE AND GUIDANCE FROM THE
FDA IS SEEN IS TAKEN QUITE
SERIOUSLY FROM INDUSTRY.
IF WE CAN GET THIS PIECE IN
THERE NOW GIVEN THE STAGE OF
WHERE DRAFT GUIDANCE IS WE
SHOULD INCLUDE THAT IN THE
REPORT.
AND I'M SPEAKING MOSTLY FROM
KNOWING THE IRB WORLD IT'S SO
ENGRAINED CULTURALLY THE
ASSUMPTION IS WE DON'T DO THAT.
THERE'S AN ACCEPTANCE THAT ONE
WOULDN'T INCLUDE PREGNANT WOMEN
IN MOST RESEARCH.
I'M TALKING ABOUT INVESTIGATION
PREGNANT AND NON-PREGNANT PEOPLE
AS PART OF THE RESEARCH.
WE DON'T TOUCH THAT.
IT'S A REAL CULTURE SHIFT TO
TELL US THE STORY WHY YOU'RE
INCLUDING PREGNANT OR LACTATING
WOMEN.
TO THE EXTENT WE CAN FOCUS ON
10A THERE NEEDS TO BE MORE WORK
TO MOVE THE NEEDLE, THAT'S
IMPORTANT.
>> THERE'S WORK DONE BY
INVESTIGATORS AND SPONSORS AND
THEIR LOCAL HUMAN ETHICS
AUTHORITY BODIES AS WELL.
THANK YOU.
>> I WANT TO APOLOGIZE FIRST IF
THIS WAS COVERED IN THE
BEGINNING I WAS DISTRACT WORKMEN
IN MY APARTMENT, TO EXTENT
THERE'S BEEN GUIDANCE DEVELOPED
AND CONVERSATIONS, HAS IT
ADDRESSED THE ROLE OF THE
MARITAL OR NON-MARITAL PARTNER
INTENDED CO-REARING PARTNER THE
DEFINITION OF WHOM IS AT ISSUE
IS SOMETIMES NOT BEEN ADDRESSED.
IN OTHER SETTINGS I'VE SEEN
EXAMPLES WHERE THE WORLD OF THE
SECOND ADULT BOTH IN TERMS OF
GIVING CONSENT UNDER SOME
LIMITED CIRCUMSTANCES AND EVEN
IN JUST KNOWING A WOMAN IS
ENROLLING IN RESEARCH BECOMES
RELEVANT TO WHETHER OR NOT YOU
CAN GET HER IN AND NOT SURE IF
THE GUIDANCES ARE BEING
DEVELOPED WITH THAT KIND OF
ISSUE IN MIND.
>> LYNN OR KEVIN DO YOU WANT TO
ADDRESS THAT?
>> RECENTLY WE PUBLISHED AN
UPDATED GUIDANCE ON INFORMED
CONSENT I BELIEVE IN SEPTEMBER
OF 2023.
IT DOES NOT TOUCH ON THE ISSUE
OF THE PARENT BEING INVOLVED IN
CONSENT.
CURRENTLY OUR REGULATIONS
REQUIRE THE WOMAN TO GIVE
CONSENT.
HOWEVER, AT TIMES DURING OUR
REVIEW OF SUCH PROTOCOLS WHEN
THERE'S UNUSUAL RISK FOR THEY
WILL TO BE INVOLVED.
>> FOR FEAR OF FAMILY MEMBERS OR
HUSBANDS KNOWING FOR EXAMPLE
SOMEONE IS HIV POSITIVE WOMEN
WOULDN'T ENROLL IN TRIALS TO
THEIR BENEFIT OR THE BENEFIT OF
THEIR FUTURE CHILDS.
THE PROTOCOLS HAD TO BE ADAPTED
SO IT CAN LIE OR COME UP WITH
NEW DELIVERY SYSTEMS WITH
INJECTIONS THAT LOOK LIKE
VITAMINS OR SOMETHING ELSE.
THINK HOW THE FAMILY SITUATIONS
ARE INVOLVED IN ENROLLMENT.
>> WE CAME UP WITH THE SAME IN
THE EBOLA CRISIS AND THINKING
CREATIVELY.
WE TRIED OUR BEST TO THINK
CREATIVELY TO PROTECT ALL PEOPLE
IN GOVERNMENT RESEARCH.
>> KEVIN.
>> I WANT TO MAKE SURE THE
WORKING GROUP IS AWARE AND THE
RECOMMENDATIONS ARE AIMED TOWARD
OUR REGULATORY COLLEAGUES.
I WANT TO STATE CURRENTLY THE
NIH DOES NOT HAVE ANY, FOR
EXAMPLE, COLLUSION OR INCLUSION
REQUIREMENTS WITHIN THE
INCLUSION POLICIES AND I'D ALSO
ADD TO THE TRACKING AND
MONITORING QUESTION PARTLY
BECAUSE THERE'S NOT A LOT OF AID
IN TRACKING INCLUSION AND
LACTATING AND PREGNANT PEOPLE IN
CLINICAL STUDIES.
IT'S LOOKING AT PUBLIC RESEARCH.
>> I WONDER IN THE MOST RECENT
COMMENT IS THERE LIKE A WAY WE
CAN GET AT THIS MORE FROM THE
NIH SIDE ESPECIALLY IS THERE
LIKE AN EASIER WAY TO MAKE THAT
A REQUIREMENT FOR NIH-FUNDED
STUDIOS.
THAT'S JUST MY QUESTION AND WE
CAN USE THAT MORE THAN WHEN
PEOPLE COME TO FDA PERHAPS.
I DON'T KNOW.
>> CAN YOU SPEAK TO WHAT THE
PATH WOULD LOOK LIKE.
>> THERE'S BEEN A VARIETY OF
WORKSHOPS RELATED TO INCLUSION
ACROSS THE LIFE SPAN THE NIH HAS
CONDUCTED AND RECOMMENDATIONS IN
REGARDS TO PREGNANCY AND
LACTATION.
I'D ENCOURAGE THE WORK GROUP TO
LOOK AT THAT.
THERE'S AN INCLUSION GOVERNANCE
COMMITTEE AT THE NIH THAT
OVERSEES THAT PROCESS.
THAT WOULD BE THE GROUP
RECOMMENDATIONS WOULD NEED TO GO
THROUGH IN REGARDS TO THAT.
I'LL LEAVE IT UP TO THE WORKING
GROUP TO CONSIDER THAT AS IT
PREPARES ITS REPORT.
>> THANK YOU.
ANY OTHER THOUGHTS ON 10 THROUGH
10E?A
THROUGH 10E?
WE'RE TALKING BEYOND
IMPLEMENTATION AND TALKING ABOUT
OUTCOMES AND PROGRESS.
IT'S CLEAR WHERE THERE NEEDS TO
BE MORE WORK AS EVIDENCED BY THE
CONVERSATIONS WE'VE BEEN HEARING
AND ALSO CLEAR WHERE WE'VE GOT A
CLEAR TRAJECTORY ON SEVERAL OF
THESE.
ANY OTHER THOUGHTS FOLKS WOULD
LIKE TO CAPTURE AROUND
RECOMMENDATIONS ON 10?
>> IN MY WORLD DEALING WITH FDA
AND EMA WHEN WE GO FOR DRUG
STUDIES.
I'M OBVIOUSLY NOT THE EXPERT
HERE BUT CURIOUS, IS THERE ANY
POSSIBILITY OF THINKING WHAT
WE'RE WRITING FDA AND WHAT
THEY'RE MOVING AHEAD AND HOW
THAT WILL CROSSOVER WHAT EMA IS
DOING SINCE THEY'RE GOING
THROUGH THE SAME KIND OF
EXERCISE.
FOR THOSE THAT WRITE CLINICAL
TRIALS FOR NEW DRUGS THE LAST
THING I WANT TO SAY DIFFERENT
GUIDANCE AND DOING ALL THE
THINGS WITH PREGNANCY AND
LACTATION.
>> MAYBE THE AGENCY CAN SPEAK TO
HARMONIZATION WITH OUR PARTNERS
ACROSS THE OCEAN?
>> THIS IS LYNNE, I'M HAPPY TO
START AND WOULD CERTAINLY HAVE
COMMENTS.
SHARON, I THINK ONE OF THE
LESSONS WE LEARNED ON THE
PEDIATRIC SIDE AND I'M A
PEDIATRIC NEPHROLOGIST BY
TRAINING, WHEN WE HAD THESE
DIFFERENT LAWS AND DIFFERENT
REGULATI
REGULATIONS MOVING FORWARD IT
CAUSED PROBLEMS WITH ONE AGENCY
SAYING ONE THING AND ANOTHER
SAYING ANOTHER.
THE FOLKS ON THE INDUSTRY AND
REGULATORY SIDE SAW THE NEED TO
START THE CONVERSATION FROM THE
START TO GET IT MORE HARMONIZED.
WE HAVE THE IHC21 GUIDELINE NOW
BEING DEVELOPED WHICH IS A
HARMONIZED SHOULD BE GLOBAL
GUIDANCE ON THE INCLUSION AND
WORKING GROUP.
WE HAVE CREATED A GROUP OF
REGULATORS THAT NEED TO DISCUSS
TOPICS AND HAVE A PREGNANCY AND
LACTATION CLUSTER DEVELOPED
SINCE THE RECOMMENDATIONS AND
IT'S USEFUL IN MAKING SURE
THEY'RE GOING IN ALL DIFFERENT
DIRECTIONS.
WE MEDE WITH REGULATORY
COLLEAGUES WHEN THERE'S ISSUES
THAT COME UP AND WORKSHOPS AND
MEETINGS.
I THINK WE ARE -- SO YOUR POINT,
SHARON, WE'RE TRIGS TO DO THE
BEST WE CAN THERE BUT THERE'S
ALWAYS ROOM FOR IMPROVEMENT AND
I'M LOOKING FORWARD TO THE
RESULTS OF THIS E21 GUIDELINE TO
SEE THIS AS A WORKING ROAD MAP
THAT ALL REGULATORY AGENCIES AND
PHARMA GROUPS WILL HAVE TO
ADOPT.
>> I'M PLEASED YOU MENTIONED THE
F21.
THAT GUIDANCE FOR THOSE WHO
AREN'T FAMILIAR WILL BE ON THE
INCLUSION OF PREGNANT WOMEN IN
CLINICAL TRIALS.
I THINK THAT IS GOING TO BE
SOMETHING AND GLAD IT WAS RAISED
WAS IT'S SOMETHING WE SHOULD
SPEAK TO AS AN OPPORTUNITY FOR
MOVING FORWARD.
IT WILL CERTAINLY INFLUENCE HOW
WE WORK IN THE UNITED STATES AND
GLOBALLY.
I'M INTERESTING TO HEAR THE WORK
GROUPS, COMMENTS, THOUGHTS,
DIRECTION, 10E IS IMPORTANT
BECAUSE THERE ARE YOUNG WOMEN
PARTICIPATING IN STUDIES FOR NEW
INVESTIGATIONAL AGENTS
CONTINUOUSLY AND WE HAVE A GREAT
OPPORTUNITY HERE TO POTENTIALLY
GENERATE INFORMATION ACROSS THE
TRIMESTERS AND NOT LIKELY TO
GENERATE ROBUST INFORMATION BUT
WHERE CAN WE LOOK TO OR WHERE
ARE WE SEEING THERE IS PROGRESS
MADE IN TERMS OF IDENTIFYING A
PATH FORWARD TO WHAT TO DO WHEN
IN THE COURSE OF THE ROUTINE
CLINICAL STUDIES ONE OF OUR
PARTICIPANTS BECOMES PREGNANT?
>> THAT'S A GREAT QUESTION TO
POSE FOR THE GROUP.
>> I HAD A QUESTION AND WHERE
DOES THAT RESPONSIBILITY LIE?
WE TALKED ABOUT OUR COLLEAGUES
AT FDA A LOT AND BEING INVOLVED
IN MANY OF THESE THINGS BUT TO
ME ESPECIALLY WHEN I LOOK AT 10E
IT'S A QUESTION THAT WOULD BE
VERY WELL ANSWERED BY PEOPLE
DOING THIS ON A DAY TO DAY BASIS
AND SO I WAS WONDERING IF THERE
WAS ANY MOVEMENT TO BRING
TOGETHER A GROUP OF EXPERTS AND
I'M KIND OF THINKING FROM
INDUSTRY OR FROM INDUSTRY AND
ACADEMIA TO REALLY KIND OF THINK
THROUGH THIS BECAUSE IS I DO
THINK THAT MAY BE AN INTERESTING
WAY TO APPROACH THIS IS TO HAVE
THE PLAN INITIALLY DEVELOPED BY
FOLKS THAT ARE AROUND THESE KIND
OF STUDIES ON A REGULAR BASIS.
>> SO COMMENTS OR THOUGHTS FROM
THE FDA AND HOW THAT MIGHT BE
CONVENED?
HOW WE MIGHT MOVE FORWARD THERE?
>> I THINK YOUR IDEA VERY
INTERESTING.
LIKE WE WERE SAYING, I SEE THE
PART ABOUT PROTOCOL DEVELOPMENT
AND IT WAS ABOUT THE PRGLAC
STUDY PLAN.
THERE'S A WAY, I SUPPOSE, IF
CONGRESS WERE TO TAKE ACTION
THAT FDA COULD POTENTIALLY HAVE
STATUTORY AUTHORITY.
I'M NOT SAYING ONE WAY OR
ANOTHER BUT IF THEY DID IT WE
COULD REQUIRE THE SYSTEMATIC
PLANS BE DEVELOPED.
IT GOES BEYOND FDA HAVING THE
AUTHORITY OR NOT.
I THINK THERE'S AN OPPORTUNITY
HERE WHERE PEOPLE IN THE SPACE
DOING ON THE GROUND RUNNING
THESE CLINICAL TRIALS TO SAY WE
HAVE TO MAKE SURE THAT THE
PROTOCOLS UNDERSTAND IF A
PATIENT BECOMES PREGNANT DURING
CLINICAL TRIAL THIS IS THE
ALGORITHM WE GO THROUGH, WE MAKE
SURE THEY'RE FOLLOWING UP ON THE
OUTCOME OF THE PREGNANCY.
WE FOLLOW THEM AND RECONSENT
THEM AND MAYBE ALLOW THEM TO
CONTINUE THE TRIAL.
THERE'S AN OPPORTUNITY FOR THESE
PEOPLE TO KNOW WHAT NEEDS TO BE
DONE.
>> I LOVE THIS IDEA AND THINK
IT'S A GREAT RECOMMENDATION AS
WELL.
THE PEOPLE THAT NEED TO HERE
THIS ARE THE OPERATIONS PEOPLE
AND THEY'RE IN CHARGE OF THE
CLINICAL TRIALS AND MOVING THEM
FORWARD.
AND TO BE WILLING TO GET
INVOLVED WITH THIS SYSTEMATIC
PLAN OF WHAT TO DO WITH WOMEN
WHO BECOME PREGNANT IN THE
CLINICAL TRIALS.
I THINK IT REQUIRES BUY-IN
WITHIN INDUSTRY FROM DIFFERENT
GROUPS THAT AREN'T TYPICALLY
PART OF THE CONVERSATIONS.
>> HAVING PARTICIPATED IN THE
DISCUSSION AND WHEN THE MOTHER
DOES BABE DOES BETTER AND MANY
WOULD LOVE GUIDANCE FROM THE
EXPERTS ON HOW TO DO THIS.
IT GENERATES INFORMATION THAT'S
USEFUL FOR THE PATIENT AND
PROVIDE AND GENERATES
INFORMATION ON THE PRODUCT WOULD
PROBABLY BE REALLY WELCOMED.
I THINK A LOT OF PEOPLE WOULD BE
EAGER TO PARTICIPATE IN THE
DISCUSSION.
>> THIS IS GREAT CONTENT FOR THE
REPORT AS WE DISCUSSED AND WHERE
WE HAVE SEEN PROGRESS AND WHAT
WE MIGHT DO TO DROP BARRIERS TO
ADDITIONAL PROGRESS.
CHRISTINA AN OTHER THOUGHTS ON
THE CONVERSATION?
>> WE'RE TRYING TO PUT TOGETHER
THE PROGRESS REPORT AND DR. YAO
CAN ONLY PUT THIS TOGETHER FROM
THE FDA PERSPECTIVE AND ANY
OTHER ASPECTS TO ADVISE ON THE
PROGRESS TO DATE ON 10A TO 10E
TO MAKE SURE IT'S AS
REPRESENTATIVE AS POSSIBLE.
>> WHEN THE IMPLEMENTATION
REPORT CAME OUT MAYBE INDUSTRY
HAD RECOMMENDATIONS THEY AGREED
TO AND HOPEFULLY THAT THINKING
HAS EVOLVED IN TERMS OF
ARTICULATING THAT IN OUR UPDATE.
>> PART OF THE REASON FOR THE
FOOT NOTES IS THOSE
RECOMMENDATIONS WERE NOT ALL
DISCUSSED AND THEY SHOWED UP IN
THE DOCUMENT SO THERE WASN'T
OPPORTUNITY FOR ROBUST
DISCUSSION OR DEBATE.
I THINK THERE ARE CLEAR ELEMENTS
AGENCY AND INDUSTRY IS 100%
ALIGNED ON AND CLEAR ELEMENTS
THAT WILL NOT HAVE CHANGED FROM
THE TIME OF THE TASK FORCE
DISCUSSION.
>> WELL, THIS WOULD BE GREAT
CONVERSATION AND WOULD LIKE TO
TURN IT BACK TO CHRISTINA TO
PERHAPS TOUCH ON THE ADDITIONAL
ISSUES THAT WERE COMING UP IN
HER SESSION WE DIDN'T HAVE TIME
TO COVER.
>> THERE WAS OFFLINE DISCUSSION
WITH THE WORK GROUP MEMBERS.
I DON'T KNOW IF YOU WANT TO
RAISE THEM AGAIN NOW.
WE HAVE TIME BUT IF IT'S FELT
WE'VE ADDRESSED ALL YOUR FOR NOW
THAT'S FINE AS WELL.
I WANT TO GIVE YOU THAT
OPPORTUNITY.
I THINK WE CAN TAKE THE
RECOMMENDATION 10 SLIDE DOWN.
I SEE THERE IS A HAND OUT.
>> I WANT TO CALL OUT THE
DISCUSSION WE WEREN'T ABLE TO
HAVE ON LIABILITY EXPOSURE
BECAUSE IT COMES UP IN
RECOMMENDATION 7A.
I KNOW THE NATIONAL ACADEMIES
REPORT WILL COME OUT IN THE NEXT
FEW MONTHS TO GIVE EMPIRICAL
INFORMATION BUT IT'S IMPORTANT
WE MAKE THE DISTINCTION BETWEEN
THE PERCEPTION AND REALITY OF
LIABILITY.
THERE'S BEEN LIABILITY BUT IT'S
ALWAYS COME UP IN THE CONTEXT OF
DRUGS NOT STUDIED IN PREGNANT
WOMEN TALKING PREGNANCY NOT
LACTATION.
THERE'S LITTLE DATA AND GETS
THROWN TO A JURY AND THE JUDGE
IS LESS EXPERT THAN THE JURY AND
YOU GET WILD RESULTS IN THE JURY
TRIALS FEEDING TO THE LEVEL OF
FEAR THAT FEEDS INTO THE CULTURE
OF PRESUMPTIVE INCLUSION.
I DON'T WANT TO CONTINUE THE
IMPRESSION LIABILITY IS A BIG
THREAT WHEN IT COMES TO
ENROLLMENT OF TRIALS AND THERE'S
A CONTROLLED CIRCUMSTANCE WHERE
THERE'S AN OPPORTUNITY TO DECIDE
WHAT LEVEL OF RISK MIGHT EXIST
AND COUNSEL THEM AND MINIMIZE
AND REACT THE MOMENT IT SEEMS
THERE'S A PROBLEM AND COUPLED
WITH THE FACT IT PROVES YOU'RE
CREATE PROTECTIVE SITUATION AND
7A POPPED OUT TALKING ABOUT
MITIGATION MEASURES AIMED AT
REDIVING LIABILITY EXPOSURE IF
I'M REMEMBERING IT CORRECTLY.
THAT'S BUYING INTO THE
UNDERLYING ASSUMPTION I DON'T
THINK IS I EMPIRICALLY JUSTIFIE.
>> I THINK YOU'RE CORRECT THERE
WAS A DISCUSSION AND THE
QUESTION OF LIABILITY RISK IN
REGARDS TO EVERY STAKEHOLDER
PARTICIPAT
PARTICIPATING AND IT'S TRICKLING
DOWN STREAM AND THE BEST
APPROACH FOR 7 IS GETTING AN
OPPORTUNITY TO DISCUSS WHEN WE
HAVE THE FACE TO FACE BECAUSE IT
NEEDS DISCUSSION TO ENSURE THIS.
>> AND ACADEMIC INSTITUTIONS ARE
EXTREMELY CONSERVATIVE IN THIS
WAY AND CONCERNED ABOUT
LIABILITY CORRECTLY OR
INCORRECTLY, ACCURATELY OR NOT
AND IT FEEDS INTO THE CULTURAL
ISSUE THAT CAME UP IN THE
COMMENT.
THAT PROBABLY UNDER LIES HOW
EFFECTIVE OTHER THINGS LIKE
GUIDANCE CAN BE IF IT'S BASED ON
AN INSTITUTIONAL CONSERVATIVE
AND FEAR ON LIABILITY
UNJUSTIFIED OR NOT YOU CAN
REMOVE THINGS FROM REGULATION
THERE'S STILL AN UNDERLYING
CONCERN AND MAY WANT TO KEEP IT
IN MIND AS WE MAKE
RECOMMENDATION.
>> IT'S BEEN A CHALLENGE YOU'RE
BEING ASKED TO DO A LOT OF WORK
AND HAVE COMMENTS ON WHAT LED TO
THE RECOMMENDATIONS BEING MADE
AND WE'RE BEING ASKED TO GIVE A
SNAPSHOT OF ACTIVITIES SO I WANT
TO THANK YOU ALL BECAUSE THIS IS
ASKING A LOT OF YOU.
GO AHEAD, KEVIN.
>> I WANT TO GIVE A QUICK UPDATE
ON THE RULES MY OFFICE IS
DEVELOPING I WAS JUST INFORMED
THE DATE THE DATE IS PUBLISH.
THE GOAL DATE IS FOR THE END OF
THE CALENDAR YEAR.
THE DATES CAN SOMETIMES SLIP FOR
A LOT OF REASONS AND AIMING FOR
THE END OF THE CALENDAR YEAR.
THANK YOU, KEVIN.
>> I'LL TURN TO YOU AND YOU CAN
GO FROM THERE.
>> I'LL RE-ECHO THE SENTIMENT TO
YOU.
WE REALIZE HOW MUCH WORK THE
GROUP IS DOING ESPECIALLY
OFFLINE AND THANK YOU FOR TAKING
THE TIME TO ARTICULATE YOUR
COMMENTS IN THE MEETING CHAT.
AGAIN, ALL THOSE ARE GETTING
CAPTURED AND THANK YOU VERY MUCH
FOR MAKING SURE WE HAVE A STRONG
ROBUST DISCUSSION AND SO WE'VE
GOT ONE MORE MEETING AHEAD OF
US.
PLEASE BE PATIENT AS WE CONTINUE
TO ROLL THROUGH THESE AND EMMA
BACK TO YOU NOW.
>> THANK YOU, SUE.
>> WE FINISHED OUR MATERIAL UP A
SHORTER TIME THAN ANTICIPATED SO
WE HAVE DOWN TIME ON OUR FRIDAY.
A COUPLE ANNOUNCEMENTS OR
UPDATES FROM US.
I DID PUT THIS IN THE CHAT BUT
THE REPORT WON'T BE RELEASED
UNTIL LATER BUT WE'RE WORKING ON
SETTING UP A BRIEFING ONCE THAT
REPORT IS OUT.
IT WILL BE OPTIONAL FOR THE
GROUP BUT MAY BE INFORMATIVE TO
OUR REPORT AND WE'LL BE DRAFTING
IN THE SPRING.
KEEP AN EYE OUT FOR THE DATE
LIKELY IN EARLY APRIL.
FOR OUR NEXT MEETING, MARCH 22
WE'RE INTENDING TO HOLD IT IN
PERSON IN BETHESDA AND THIS IS
SPONSORED TRAVEL YOU SHOULD HEAR
FROM LESLIE McCLAIN OUR
CONTRACTOR SUPPORTING THIS GROUP
ABOUT ARRANGING THE TRAVEL
INCLUDING FLIGHTS AND HOTEL FOR
THAT AND VERY MUCH LOOKING
FORWARD TO THE OPPORTUNITY TO
GET TO MEET YOU IN PERSON FOR
THAT AND FINALLY FOR OUR
POST-MEETING WORK WE WILL WORK
ON A SIMILAR DOCUMENT TO THE
DOCUMENT FOR RECOMMENDATION 13.
THE GOAL STO GET THAT SENT TO
YOU BY JANUARY 29 BY THE END OF
THE DAY AND ASKING TO RETURN BY
FEBRUARY 12.
WE'LL SYNTHESIZE THE COUGHINGS
IN THE DOCUMENT AND GET THAT OUT
TO YOU ALONG WITH THE SLIDES
FROM THE SPEAKERS TODAY.
I THINK WE CAN CLOSE OUT UNLESS
ANYBODY HAS QUESTIONS THE LAST
LOGISTICAL PIECES OF
INFORMATION.
>> I DO HAVE ONE QUESTION, THIS
IS ALISON.
I WANTED TO KNOW WILL THE
COMMENTS AND REFERENCES IN THE
CHAT ALL BE PART OF THE FORMAL
MINUTES?
>> WONDERING IF YOU'RE GOING TO
DOWNLOAD THAT OR CAPTURE THAT.
>> WE'LL CAPTURE THE CHAT IN THE
MINUTES AND I ALSO HAVE I'LL
DOWNLOAD THE ENTIRE TRANSCRIPT
OF THE CHAT IF ANYBODY WANTS TO
REVIEW IT SOONER THAN THE
MINUTES ARE AVAILABLE.
AND THE MARCH 22 MEETING WILL BE
AT LEAST PARTIALLY OPEN TO THE
PUBLIC.
OTHER QUESTIONS?
OKAY.
WELL, CHRISTINA, ANY LAST WORDS.
>> THANK YOU AGAIN TO THE GROUP
AND A VERY BIG THANK YOU.
I FORGOT TO MENTION THIS TO OUR
COLLEAGUES AT NICHD WHO WORKED
DILIGENTLY BEHIND THE SCENES SO
MAKE SURE WE PREPARED TODAY.
>> AND THANKS TO PALLADIUM FOR
HELPING US OUT FOR THE MEETING. 3804 03:18:38,506 THANK YOU, EVERYBODY.