WELCOME TO THE 179th MEETING
OF THE NICHD ADVISORY COUNCIL.
ONCE AGAIN WE APPRECIATE YOUR
ACCOMMODATION OF THE VIRTUAL
FORMAT FOR TODAY'S MEETING.
TODAY THE ENTIRE MEETING IS OPEN
TO THE PUBLIC AND IT'S BEING
BROADCAST ON THE NOW WORKING NIH
VIDEOCAST NETWORK AND I WOULD
ALSO LIKE TO THANK THOSE MEMBERS
OF THE PUBLIC WHO ARE PRESENT ON
THE CALL ESPECIALLY THOSE
REPRESENTING PROFESSIONAL
SOCIETIES AND RESEARCH
ORGANIZATIONS.
I WOULD LIKE TO THANK EVERYONE
FOR JOINING US TODAY.
WITH THE VIRTUAL MEETING FORMAT,
I THINK WE'RE ALL EXPERTS ON
THIS NOW, BUT PLEASE REMEMBER TO
UNMUTE YOURSELF BEFORE SPEAKING
INTO YOUR MICROPHONES AND STATE
YOUR NAME SO THAT THE
TRANSCRIBER AND VIDEOCAST
OBSERVERS WILL KNOW WHO'S
SPEAKING EMPLOY NOW I REALIZE
MOST PEOPLE WILL HAVE THEIR
NAMES BUT SOME PEOPLE WILL HAVE
PHONE NUMBERS.
AFTER YOU SPEAK, PLEASE BE SURE
TO MUTE YOUR MICROPHONE TO
PREVENT ANY FEEDBACK LOOPS OR
ANY OTHER AUDITORY
INTERFERENCES, SO WITHOUT
FURTHER ADO, I WOULD LIKE TO
TURN THE MEETING OVER TO
DR. DENNIS TWOMBLY.
DENNIS?
DENNIS, YOU ARE MUTED.
AFTER I JUST SAID UNMUTE
YOURSELF.
[LAUGHTER]
EMPLOY.
>> SORRY, HAD THE ZOOM SCREEN ON
ANOTHER MONITOR.
OT COUNCIL MEMBER WEBSITE, YOU
SHOULD HAVE READ, AX GREED EXPO
SIGNED THE AGREEMENT FOR
NONDISCLOSURE RULES FOR
GOVERNMENT EMPLOYEES BEFORE
EVALUATING ANY NIH GRANT
APPLICATION.
ALSO YOU SHOULD HAVE RECEIVED
YOUR CONFLICT OF INTEREST FORMS
VIA E-MAIL.
IF YOU HAVE NOT, PLEASE LET MISS
LISA NEAL KNOW SO SHE CAN SEND
YOU THE APPROPRIATE DOCUMENT.
PLEASE SIGN THE CONFLICT OF
INTEREST CERTIFICATION FORM
PRIOR TO THE CLOSED SESSION FOR
THE REVIEW OF APPLICATIONS
TOMORROW AND SEND THEM TO MISS
LISA NEAL.
ALSO REMEMBER YOU CANNOT SERVE
ON ANY NIH PEER REVIEW PANEL
WHILE SERVING AS A COUNCIL
MEMBER.
AND YOU CANNOT PROVIDE SECOND
REVIEW AT COUNCIL FOR ANY
APPLICATION WHERE YOU HAD
PARTICIPATE INDEED THE FIRST
LEVEL PEER REVIEW.
IT'S NIH'S POLICY THAT AN
INDIVIDUAL CANNOT SERVE ON BOTH
THE FIRST AND SECOND LEVELS OF
PEER REVIEW.
IN ADDITION I NEED TO BRING TO
YOUR ATTENTION THAT DURING
CLOSED SESSION TOMORROW, PLEASE
TURN OFF CLOUD BASED VOICE
SERVICES IN YOUR HOME OR OFFICE
SUCH AS ALEXA DEVICES AS THESE
DEVICES MAY OR MAY NOT CAPTURE
CONFIDENTIAL INFORMATION.
THE MINUTES FOR THE
JANUARY 11th 2022 MEETING HAVE
ALREADY BEEN POSTED ON THE NICHD
COUNCIL MEMBER WEBSITE.
WE'VE ALREADY GONE THROUGH THE
VOTING PROCEDURES, SO EVERYBODY
SHOULD BE READY TO DO THAT.
AND AT THIS POINT, MAY I HAVE A
MOTION TO APPROVE THE JANUARY
MINUTES?
>> THIS IS SHERRY BARKIN, MOVE
TO APPROVE.
>> THANKS, SHERRY.
SECOND?
>> SECOND.
>> THANK YOU.
SO NOW PLEASE VOTE FOR, AGAINST
OR ABSTAIN USING THE BUTTONS AT
THE BOTTOM OF THE ZOOM SCREEN IN
THE PARTICIPANTS VIEW, IF YOU'RE
VOTING IN FAVOR CLICK THE GREEN
CHECK MARK, IF YOU VOTING NOT IN
FAVOR CLICK THE RED X, AND IF
YOU ARE ABSTAINING CLICK THE
RAISED HAND ICON.
OKAY, LIZ, DO WE HAVE EVERYBODY?
>> WE HAVE 11, YESs.
YOU HAVE MORE THAN THAT I THINK.
>> I'M NOT SURE ALL COUNCIL
MEMBERS ARE ON THE CALL.
WHO IS MOM'S IPHONE BECAUSE THAT
PERSON IS VOTING IN THE
AFFIRMAATIVE.
>> THAT'S CHRISTINA, SORRY I'M
IN TRANSIT.
>> THANK YOU.
>> I CAN'T CHANGE THE NAME.
I APOLOGIZE I WILL BE JUST FOR
THE FIRST HALF OF THE CALL.
>> WE CAN GO AHEAD AND CHANGE IT
FOR YOU.
I WILL DO THAT IN A JUST A
SECOND.
>> THANK YOU.
>> SO NOW I'M SHOWING 12.
>> OKAY, HAS EVERYBODY HAD A
CHANCE TO VOTE.
DR. LANG?
>> SORRY I I'M NOT FINDING A
BUTTON TO VOTE, CAN I VOTE WITH
A REACTIONS, IS THAT OKAY?
>> WELL, NO, YOU CHECKED IT OFF.
IT'S COMING ACROSS AS A GREEN
CHECK.
>> THANK YOU.
>> GOT IT.
>> OKAY, GREAT.
OKAYS, I THINK WE HAVE IT SO
LET'S MOVE ALONG.
ON THE AGENDA YOU SEE A LIST OF
FUTURE MEETING DATES, GOING
THROUGH 2024.
THE NEXT 1 COMING UP IS
SEPTEMBER 12th AND 13th.
WE'VE SCHEDULED IT FOR 6710 B
ROCKLEDGE, IN ROCKVILLE AND
WE'RE HOPING TO DO IT LIVE BUT
THAT WILL BE CONFIRMED FOR YOU
LATER AT SOME POINT IN TIME.
THAT'S THE HOPE, ANYWAY.
SO AT THIS POINT, I WILL TURN
THE MEETING BACK TO DR. BIANCHI
TO PRECEPT THE DIRECTOR'S
REPORT.
DR. BIANCHI?
>> THANK YOU SO MUCH, DENNIS, IF
AND I COULD HAVE THE SLIDES
PLEASE?
WONDERFUL.
HOPE EVERYBODY CAN SEE IT IN
PRESENTATION MODE, AS DO I.
OKAY, I'M HAPPY TO GIVE YOU THE
DIRECTOR'S REPORT, LET'S GO TO
THE NEXT SLIDE.
SO I HAVE A LOT TO COVER TODAY
INCLUDING PLANS FOR THE 60th
ANNIVERSARY, BUDGET UPDATES SOME
OF WHICH YOU MAY KNOW ABOUT,
SOME SELECTED COVID-19 RESEARCH
UPDATES BUT THE REMAINDER OF THE
PRESENTATION AND BOTH NEW
RESEARCH AS WELL AS EVERYONE TO
BE AWARE OF NICHD'S ENGAGEMENT
IN SOME OF THESE MAJOR NIH-WIDE
INITIATIVES AND THEN LASTLY I
WILL GIVE YOU AN UPDATE ON STAFF
UPDATES.
NEXT SLIDE, PLEASE.
SO OUR ANNIVERSARY IS COMING UP.
THE ACTUAL 60th ANNIVERSARY IS
ON OCTOBER 17th OF THIS YEAR
AND THE THEME FOR THE RESEARCH
SYMPOSIUM IS HEALTHY
PREGNANCIES, HEALTHY CHILDREN
AND HEALTHY AND OPTIMAL LIVES
WHICH YOU MIGHT RECOGNIZE AS OUR
VISION STATEMENT.
WE HAVE BEEN WORKING ACTIVELY ON
IT, WE HAVE QUITE A NUMBER OF
CONFIRMED SPEAKERS AND WE ARE
MORE THAN LIKELY GOING TO HAVE
IT AS A VIRTUAL EVENT.
SO WE HAVE BEEN GOING BACK AND
FORTH EENCH AS RECENTLY AS THIS
MORNING AS TO WHAT IS GOING TO
BE THE SAFEST THING TO DO, SO
IT'S STILL NOT OFFICIALLY
CONFIRMED, BUT WE'RE LEANING
TOWARDS VIRTUAL ONLY BECAUSE THE
PANDEMIC IS NOT OVER YET AND WE
ARE CONCERNED ABOUT WHAT'S GOING
TO BE HAPPENING IN THE FALL.
IN THE MEAN TIME WE HAVE A
WONDERFUL 60th ANNIVERSARY
WEBPAGE THAT YOU CAN SEE HERE,
WHICH WILL GIVE YOU ESPECIALLY
FOR NEW COUNCIL MEMBERS SOME
INTERESTING INFORMATION ON
MILESTONES AND NICHD'S HISTORY,
KEY SCIENTIFIC ADVANCES,
SPOTLIGHTS ON PEOPLE WHO HELP US
ACHIEVE OUR MISSION AND WILL BE
DISCUSSING THE ANNIVERSARY--SO
WE HAVE AN UPTO SUMMIT OF WHAT'S
HAPPENING AND THE ANNIVERSARY,
IT'S ON THAT WEBPAGE.
NEXT SLIDE, PLEASE.
SO THE BUDGET.
YOU MIGHT RECOGNIZE THAT SINCE
THE LAST--WHEN WE MET IN
JANUARY, WE DIDN'T HAVE AN
OFFICIAL BUDGET.
IT WAS STILL ON A CONTINUING
RESOLUTION.
THE BUDGET WAS SIGNED BY THE
PRESIDENT ON MARCH 15th AND AS
I LIKE TO SAY, THAT MEANS THAT
OUR STAFF IS DOING TWICE THE
AMOUNT OF WORK IN HALF THE
AMOUNT OF TIME.
I DON'T THINK I REALIZE THAT
BEFORE COMING TO GOVERNMENT,
WHAT IT MEANT WHEN THE SIGNING
OF THE BUDGET WAS DELAYED BUT IT
REALLY MEANS A HUGE NUMBER OF
INITIATIVES NEED TO GET
FINALIZED, OPPORTUNITIES FOR
FUNDING HAVE TO BE PUT OUT
PUBLICLY VERY QUICKLY AND THERE
IS TO SOME EXTENT A BIAS, THEN
TO WELL PREPARE INVESTIGATORS,
WELL RESOURCED INSTITUTIONS.
THE THERE WAS A SLIGHT INCREASE
FOR NIH, THE TOTAL BUDGET IS NOW
45 BILLION DOLLARS AND A SLIGHT
INCREASE FOR NICHD, WE'RE NOT
QUITE AT 1.7 BILLION YET BUT WE
WILL BE THERE SOON, HOPEFULLY
AND MOST NOTABLY THERE WERE 2
CALL OUTS SPECIFICALLY FOR
CHILDREN AND FOR NICHD.
SO THERE WAS A $7.5 MILLION
APPROPRIATION FOR THE IMPACT OF
COVID-19 ON CHILDREN WHICH IS
SIGNIFICANT BECAUSE THEY HADN'T
BEEN RECOGNIZED PREVIOUSLY AND
EVEN MORE SIGNIFICANTLY THERE
WAS A 30 MILLION-DOLLAR SPECIFIC
APPROPRIATION FOR THE INITIATIVE
IMPLEMENTING MATERNAL HEALTH AND
PREGNANCY HEALTH OUTCOMES FOR
EVERYONE WHICH WAS PLACED IN THE
NICHD BASE AND WE ARE VERY
GRATEFUL TO CONGRESS FOR DOING
THAT BECAUSE ONCE SOMETHING IS
PUT IN THE BASE, THEN WHEN
THERE'S ACROSS THE BOARD, LET'S
SAY 2 OR 3% INCREASE, IT'S THAT
MUCH MORE BECAUSE NOW OUR BASE
IS THAT MUCH HIGHER.
IN ADDITION MONEY WAS GIVEN TO
CONTINUE THE GABRIELA MILLER
KIDS FIRST RESEARCH ACT, THAT
SITS IN THE COMMON FUND SO
ALTHOUGH WE ARE HEAVILY INVOLVED
STAFF WISE, THE MONEY ACTUALLY
GOES TO THE OFFICE OF THE
DIRECTOR.
AND I'M SURE YOU'VE BEEN READING
A LOT ABOUT ARP A-H, WHICH IS
THE PRESIDENT'S VISION TO
RAPIDLY ACCELERATE TREATMENTS.
HE REQUESTED 6 BILLION DOLLARS,
CONGRESS DECIDED TO APPROPRIATE
1 BILLION DOLLARS AND WE'RE NOW
BEGINNING TO HEAR ABOUT AN
ACTING DIRECTOR AND A PROPOSED
INFRASTRUCTURE.
NEXT SLIDE, PLEASE BUT IT'S
IMPORTANT TO KNOW THAT ARP A H-H
WILL NOT BE INSIDE NIH MPLET THE
DIRECTOR WILL REPORT TO HEALTH
AND HUMAN SERVICES AND THE
PHYSICAL SPACE FOR ARP A H-H
WILL BE OUTSIDE OF THE RNIH
CAMPUS.
NEXT SLIDE, PLEASE.
EVERY YEAR, SO EVEN BEFORE WE
HAD A FISCAL YEAR 22 BUDGET WE
WERE WORKING ON THE FISCAL YEAR
23 BUDGET AND OUR OSPRA FOLKS
ARE ALWAYS WORKING ESSENTIALLY
ON THE NEXT BUDGET AND THEY DO A
REALLY GREAT JOB OF PUTTING
TOGETHER THE CONGRESSIONAL
JUSTIFICATION WHICH TALKS ABOUT
HIGHLIGHTED PROGRAMS, TALKS
ABOUT WHAT WE DO WITH THE MONEY
IF WE HAD IT AND THEN LAST FEW
YEARS WE'VE ALSO HAD A FACT
SHEET WHICH IS PUBLICLY
AVAILABLE AND KIND OF GIVES YOU
A 1 YEAR SNAPSHOT OF WHAT HAS
HAPPENED IN THE PREVIOUS YEAR.
AND WE TRY TO HIGHLIGHT ALL OF
OUR ACTIVITIES, SO THINGS THAT
RELATE TO CHILDREN, PEOPLE OF
REPRODUCTIVE AGE, PREGNANT
PEOPLE, AND PEOPLE WITH PHYSICAL
AND INTELLECTUAL DISABILITIES.
NEXT SLIDE, PLEASE.
>> THE SPRING HAS BEEN QUITE
BUSY, A LOT OF IN-PERSON
MEETINGS SO I WAS FORTUNATE TO
ATTEND THE MATERNAL HEALTH
ACTION PLAN CABINET MEETING,
HELD BY VICE PRESIDENT HARRIS AT
THE WHITE HOUSE, YOU CAN SEE HER
AT THE END OF THE TABLE AND IN
THE LOWER RIGHT OF THE SLIDE, IS
DR. TABAK AND I WAS SITTING
SOMEWHERE TO THE LEFT OF THE
OFFICIAL PHOTOGRAPHERS.
IT WAS REALLY INTERESTING AND
INSPIRING TO HEAR WHAT THE VICE
PRESIDENT HAD TO SAY, HOW
COMMITTED SHE IS TO MATERNAL
HEALTH, TO REDUCING DISPARITIES,
HOW KNOWLEDGEABLE SHE IS AND HOW
THOUGHTFUL SHE WAS IN TERMS OF
DECIDING WHICH CABINET MEMBERS
WOULD BE INVITED TO THIS
MEETING.
SO FOR EXAMPLE, SHE INVITED THE
SECRETARY OF HOUSING AND URBAN
DEVELOPMENT MARSHA FUDGE TO TALK
ABOUT THE EFFECTS OF
HOMELESSNESS ON PREGNANT PEOPLE
SHE WENT THROUGH--SHE TALKED
ABOUT DULAs WITH HER GOOD
FRIEND FORMER BOSTON MAYOR MARTY
WALSH WHO'S NOW THE SECRETARY OF
LABOR.
SHE TALKED ABOUT VERY
KNOWLEDGEABLY ABOUT WANTING TO
PROFESSIONALIZE DULAs, SO IT
WAS VERY CONCRETE AND
SUBSTANTIVE AND ON THE WAY BACK
TO NIH, I TALKED WITH DR. TABAK
WHO'S NOW THE ACTING DIRECTOR OF
NIH AND ATTENDS THE PRESIDENT'S
CABINET MEETINGS AND HE SAID
THIS MEETING WAS MUCH MORE
SUBSTANTIVE AND THAT THE
PRESIDENT'S MEETINGS ARE NOT
QUITE AS DETAILED AND IT'S CLEAR
AND THE VICE PRESIDENT'S STAFF
IS VERY, VERY COMMITTED TO THIS
PROJECT SO WE HAVE CONGRESSIONAL
APPROPRIATION WE HAVE EXECUTIVE
BRANCH AND IN ADDITION WE HAD
SENATE APPROPRIATION COMMITTEE
STAFF ASKING US QUESTIONS SO WE
DID A BRIEFING WITH THEM ALSO
AROUND THE TIME PERIOD AND
LASTLY, MOSE FRANKLE WHO IS ON
THE HOUSE COMMITTEE AND
APPROPRIATIONS FOR LABOR HHS IS
VERY INTERESTED IN WHAT'S
HAPPENING WITH [INDISCERNIBLE]
SHE HAS A DAUGHTER IN LAW WHO IS
BREAST FEEDING AND SHE'S VERY
CONCERN BODY MEDICATIONS AND
BREASTED MILK AND WE DID A
BRIEFING WITH HER AND HER STAFF
AND MULTIPLE OTHER MEMBERS OF
CONGRESS SO SOME OF OUR KEY
PROGRAMS THAT ARE INIH WIDE AND
THEY ARE VERY ALIGNED WITH OUR
MISSION AND VISION, ARE COMING
TO THE ATTENTION OF THE
LEGISLATIVE AND THE EXECUTIVE
BRANCH, NEXT SLIDE, PLEASE.
WHAT I ALWAYS REFER TO AS MY
PERSONAL FINALS IN THE SPRING,
IF I AM ASKED TO TESTIFY AT THE
HOUSE APPROPRIATIONS
SUBCOMMITTEE LABOR, HHS, I
ACCOMPANY 5 OTHER COLLEAGUES
INCLUDING DR. TABAK ON MAY
11th AND YOU'RE PREPARED FOR
ANYTHING.
COULD BE THE STAFF AT NICHD, THE
LEGISLATIVE AND PUBLIC POLICY
STAFF ARE PREPARING US FOR
ANYTHING AT NICHD AND ALSO IN
THE OFFICE OF THE DIRECTOR AND
WE HAVE TO GO THROUGH A
[INDISCERNIBLE] MURDER AND
RESPOND TO FAKE QUESTIONS JUST
TO BE PREPARED BUT IT IS--IT'S A
VERY GOOD EXERCISE.
IT ALLOWS TO YOU REALLY BE IN
COMMAND OF THE ENTIRE PORTFOLIO
THAT HAS BEEN SUPPORTED IN THE
PAST YEAR.
THE MAJOR TOPICS THAT CAME UP
WITH THIS HEARING, WHICH BY THE
WAY IS REPORTED, YOU CAN WATCH
IT IF YOU WANT, A LOT OF
QUESTIONS FOR DR. TABAK ON ARP
A-H.
WHICH YOU KNOW IS NOT GOING TO
BE IN NIH BUT SOME OF THE
SERVICES OF NIH WILL BE USED TO
GET ARP A-H OFF THE GROUND.
RESILIENCE SEBTATIVES WERE
INTERESTED IN MENTAL HEALTH
ISSUES IN ADULTS AND CHILDREN,
AS WELL AS UPON AN INCREASE IN
OPIOID RELATED DEATHS DURING OF
THE TIMING WAS PANDEMIC.
NICHD, HAS IN MYSELF WAS ASKED 3
QUESTIONS, 1 HAD TO DO WITH
MATERNAL HEALTH, 1 HAD TO DO
WITH WHAT'S NEW IN STILL BIRTH
AND 1 HAD TO DO WITH WHAT ARE WE
DOING SPECIFICALLY TO ADDRESS
THE ISSUES RELATED TO MENTAL
HEALTH DURING THE PANDEMIC.
THERE WERE A NUMBER OF OTHER
QUESTIONS THAT WEREN'T
NECESSARILY DIRECTED TOWARDS ME
BUT DO AFFECT CHILDREN AND THESE
INCLUDED THE FUTURE FOR ECHO
PROGRAM, DRUG ADDICTION IN
TEENS, AND ALSO WHAT ARE WE
GOING TO BE DOING ABOUT FIREARMS
AND VIOLENCE.
NEXT SLIDE, PLEASE.
NEXT SLIDE.
SO I HAVE MENTIONED TO YOU
PREVIOUSLY ABOUT THE PREVAIL
KIDS PROGRAM, THE PREVAIL KIDS
IS AN ACRONYM FOR PREDICTING
VIRAL ASSOCIATED INFLARMATORY
DISEASE IN CHILDREN WHO HAVE
LABORATORY STATISTICS AND
ARTIFICIAL INTELLIGENCE.
IT'S REALLY INTERESTING TO SEE
THE SPECTRUM OF SARS-COV-2 ILL
EXPNS IN PARTICULAR IDENTIFY
CHILDREN WHO WOULD BE AT RISK
FOR DEVELOPING MIS-C WITH A
VARIETY OF DIFFERENT TYPES OF
BIOMARKERS AS WELL AS
BIO-INFORMATICS AND THIS PROGRAM
IS FUNDED THROUGH THE RAD-X
RADICAL INITIATIVE.
NEXT SLIDE, PLEASE.
SO THEY'RE 1 YEAR INTO IT, IT'S
A LITTLE OVER A YEAR THAT THE
PROGRAM HAS BEEN FUNDED WE WERE
ABLE TO FUND 8 AWARDS WITH LARGE
NUMBERS OF CHILDREN BOTH FROM
RETROSPECTIVE COHORTS THAT WERE
INTERNATIONAL IN NATURE AS WELL
AS PROSPECTIVELY ENROLLING
CHILDREN WITH SARS-COV-2.
WE WILL GIVE YOU 2 EXAMPLES OF
SUCCESSFUL PROGRAMS.
THEY'VE ALL BEEN SUCCESSFUL IN
ACHIEVING THEIR GOALS AND
THEY'RE MAKING THEIR CASE TO
TRANSITION TO AN R33 MECHANISM,
NOW, BUT SEVERAL OF THE PROGRAMS
THAT HAVE VERY, VERY PROMISING
RESULTS HAVE BEEN ABLE TO
LEVERAGE THE NIH SMALL BUSINESS
EDUCATION AND ENTREPRENEURIAL
DEVELOPMENT PROGRAM, THE SEED
PROGRAM TO PROMOTE RAPID
TRANSLATION EUA APPLICATIONS
WITH THE FDA.
AND THAT'S REALLY THE METRIC OF
SUCCESS.
IF THIS TRANSLATE THROUGH AN FDA
APPROVED TEST AND THEN IT'S
IMPLEMENTED INTO THE COMMUNITY.
SO 1 IS A--[AUDYE CUTS OUT ]
USING DIFFERENT MARKERS SO GENE
EXPRESSION, PROTEIN, ASPECT BODY
AS WELL AS CLINICAL PARAMETERS
TO PREDICT WHO WILL PROGRESS TO
SEVERE COVID-19 AS WELL AS
MIS-C.
CURRENTLY, THEY HAVE A PREEUA
APPLICATION FOR A DIAGNOSTIC
ALGORITHM KNOWN AS KID MATCH TO
DISTINGUISH BETWEEN MIS-C,
KAWASAKI DISEASE AND OTHER
FIBERAL ILLNESSES WITH GREATER
THAN 95% ACRASE MODEL EXPE THIS
IS HIGHLY SIGNIFICANT BECAUSE IT
WOULD AFFECT HOW YOU TREAT
CHILDREN AND DIFFERENT
TREATMENTS FOR EACH OF THESE
CONDITIONS.
DR. [INDISCERNIBLE] GROUP IS
TRAINING MACHINE LEARNING
ALGORITHMS TO IDENTIFY
PROGRESSIVE DISEASE CASES AT
INITIAL PRESENTATION.
THEY'RE USING AN INFLAMMATORY
SIGN O KINE AND CHEMOKINE PAN
AND HE WILL THEY'VE ALSO FOUND
CERTAIN SOCIAL DETERMINANTS OF
HEALTH THAT ALSO PREDICT WHO IS
AT RISK.
SO BOTH OF THESE HAVE ALREADY
PROGRESSED, JUST SLIGHTLY OVER A
YEAR WHILE WE'RE WAITING FOR
MORE INFORMATION FROM THE OTHER
6 GROUPS.
THE 8 GROUPS WHO DID NOT
COLLABORATE BEFORE THIS PROGRAM
HAVE ALSO COLLABORATED, THE
MAJORITY OF THEM COLLABORATED TO
FORM A PEDIATRIC COHORT FOR THE
RECOVER PROGRAM WHICH IS AN NIH
WIDE PROGRAM THAT INCLUDES
PEOPLE OF ALL AGES WITH LONG
COVID.
BUT THEY ARE 1 OF THE PEDIATRIC
COHORTS.
NEXT SLIDE.
SO ANOTHER THING THAT WE'RE
QUITE CONCERNED ABOUT IS JUST
KEEPING AN EYE ON THE LONG-TERM
NEURODEVELOPMENTAL EFFECTS, OR
CHILDREN, PARTICULARLY IF THEY
WERE BORN TO MOTHERS WHO WERE
INFECTED DURING THEIR
PREGNANCIES.
WE DO KNOW THAT SARS COV 2
INFECTION DOES NOT CROSS THE
PLACENTA AND GET TRANSMITTED TO
THE FETUS REGULARLY.
THERE ARE A FEW CASE REPORTS BUT
IT IS INFREQUENT.
HOWEVER, KNOWING EXPERIENCES
WITH OTHER VIRAL ILLNESSES THAT
CAUSE FEVER, THAT CAUSE SYSTEMIC
DISEASE IN THE MOTHER, WE KNOW
THAT THERE CAN BE
NEURODEVELOPMENTAL EFFECTS, SO
IN 1 STUDY THAT WAS PUBLISHED
QUITE RECENTLY IN 255 CHILDREN
[AUDCROW CUTS OUT ] SHOWED
SLIGHT DECREASES IN THEIR FINE
MOTOR, GROSS MOTOR AND SOCIAL
SKILLS COMPARED TO INFANTS BORN
PREPANDEMIC.
NOW THIS GROUP CONCLUDED THAT
EVERYBODY WAS AFFECTED BY THE
PANDEMIC.
IT DIDN'T MATTER IF YOU WERE
INFECTED OR NOT.
HOWEVER, JUST RECENTLY IN THE
LAST FEW DAYS, A DIFFERENT STUDY
COMING OUT OF MASS GENERAL FROM
ED ET ALL, SUGGESTED THAT BABIES
BORN TO MOTHERS WHO WERE
INFECTED DURING THEIR
PREGNANCIES AT 1 YEAR OF AGE HAD
ROUGHLY A DOUBLE OF THE
INCIDENCE OF NEURODEVELOPMENTAL
COMPLICATIONS, SO, THIS IS
SOMETHING WE HAVE BEEN WORRY
BODY AND WE ARE ANTICIPATING AND
WE NEED TO STUDY.
NEXT SLIDE, PLEASE.
AND THEN I TALKED PREVIOUSLY
ABOUT MASSIVE STUDIES ON DATA IN
STUDENTS ON 9 STATES AND LOOKING
AT STAFF, BOTH TEACHERS AND
SUPPORT STAFF, SHOWING CLEAR CUT
EVIDENCE FROM THE GROUP, THE ABC
SCIENCE COLLABORATIVE GROUP THAT
MASKING DURING SCHOOL HAD A
SIGNIFICANT EFFECT ON REDUCING
THE CASES OF IN-SCHOOL
TRANSMISSION.
SO THE BEST WAY TO KEEP CHILDREN
IN SCHOOL IS TO KEEP THEM
MASKED.
I BELIEVE THAT THERE HAS BEEN
RELAXED A LITTLE BIT NOW BUT WE
DO HAVE THE DATA THAT MASKING
DOES WORK.
NEXT SLIDE, PLEASE.
OKAY, SO WHAT'S HAPPENING
OUTSIDE OF COVID, REMEMBER THAT
WE DO HOUSE THE NATIONAL CENTER
FOR REHABILITATION RESEARCH AT
NICH D AND I'M HAPPY TO SAY THAT
THE LIMB LOSS AND PRESERVATION
REGISTRY HAS FINALLY BEEN
LAUNCHED.
THIS IS A REGISTRY THAT IS BEING
ACTIVATED IN COLLABORATION WITH
THE DEPARTMENT OF DEFENSE,
HERE'S THE WEBSITE FOR IT.
THERE'S ALSO AN UNDERGRADUATE
PRICE COMPETITION THAT IS BEING
COSPONSORED WITH NIBIB AND
THAT'S CALLED THE DEBUT AND
THERE ARE ALSO NEW
MCMRRRESPONSIVE AND
REHABILITATIVE AND EXISTIVE
TECHNOLOGY AWARDS THAT ARE
CURRENTLY UNDER REVIEWS.
AND THERE'S ALSO BEEN A
REHABILITATION SPEAKER SERIES
FEATURING THESE SPEAKERS HERE.
NEXT SLIDE, PLEASE.
SO, I KNOW THAT EVERYONE IS
CONCERNED ABOUT FIREARM
VIOLENCE, PARTICULARLY IN SCHOOL
AGED CHILDREN AND I WANTED YOU
TO KNOW THAT WE DO SUPPORT THE
RESEARCH ON PROVENTING VIOLENCE
FROM FIREARMS, AS WELL AS
COMMUNITY BASED INTERVENTIONS TO
PREVENT VIOLENCE AS WELL AS
EXAMINING SOCIAL AND ACADEMIC
FACTORS THAT LEAD TO RISKY
BEHAVIORS IN YOUTH.
WE ALSO FUND RESEARCH IN
SETTINGS THAT ARE CONDUCIVE TO
GUN SAFETY EDUCATION AND
POPULATION STUDIES THAT ANALYZE
TRENDS IN GUN OWNERSHIP AND
ACCESS.
IN 2020 I DON'T THINK WE HAVE
THE FINAL NUMBERS FROM 21.
2020 WE AWARDED NEARLY
$2.5 MILLION TO SUPPORT
RESEARCH, TO IMPROVE
UNDERSTANDING AND PREVENTION OF
FIREARM, VIOLENCE AND MORTALITY
AND WE COLLABORATE WITH THE
OFFICE OF BEHAVIORIAL
SCIENCE--BEHAVIOR AND SOCIAL
SCIENCE RESEARCH WHICH IS IN THE
OFFICE OF THE DIRECTOR AND THEY
HAVE 2 FUNDING OPPORTUNITY
ANNOUNCEMENTS ON RESEARCH AND
COMMUNITY LEVEL INTERVENTIONS
FOR FIREARM AND RELATED
VIOLENCE, INJURY AND MORTALITY
PREVENTION AND THAT WILL--THOSE
FOAs WILL SUPPORT A NETWORK OF
RESEARCH PROJECTS TO DEVELOP AND
TEST PERSPECTIVE INTERVENTIONS
AT THE COMMUNITY LEVEL TO
PREVENT FIREARM AND RELATED
VIOLENCE.
NEXT SLIDE, PLEASE.
SO WE WANTED TO SPOTLIGHT 1
NICHD R24 GRANT WHICH IS A
RESOURCE GENERATING AWARD TO THE
UNIVERSITY OF MICHIGAN ANN ARBOR
AND WHAT THIS IS DOING IS
GATHERING A MULTIDISCIPLINARY
TEAM OF RESEARCHERS AND
STAKEHOLDER PARTNERS, SUCH AS
GUN OWNERS, OR FIREARMS
INSTRUCTORS TO DEFINE A
PEDIATRIC SPECIFIC FIREARM
INJURY PREVENTION RESEARCH
AGENDA.
SO THIS GROUP CONDUCTS PILOT
STUDIES THAT ADDRESS KEY
RESEARCH QUESTIONS SO 1 EXAMPLE
AND A PROJECT CALLED STORE
SAFELY, SAFE FIREARM STORAGE FOR
FAMILIES.
AND THIS IS TO DEVELOP AND
IMPLEMENT A NEW ONLINE FIREARM
SAFETY EDUCATION PROGRAM THAT IS
TAYLORED FOR FAMILIES IN THE
RURAL COMMUNITIES.
THERE'S A UNIVERSITY COMMUNITY
PARTNERSHIP THAT IS BEING
DEVELOPED TO TAYLOR SPECIFIC
CULTURALLY APPROPRIATE MESSAGES
AND THEY HAVE FOCUS GROUPS.
THERE ARE TRUSTED MESSENGERS,
WHO WILL THEN IDENTIFY COB TENT
AND MESSAGE CONTENT THAT WOULD
WORK FOR THIS PARTICULAR GROUP.
THE OVERALL PERSPECTIVE IS THAT
THEY RESPECT THE REASONS FOR GUN
OWNERSHIP BUT THE IMPORTANCE IS
DISCUSSING WAYS TO REDUCE HARM,
PARTICULARLY FOR CHILDREN.
AND THERE IS A YouTUBE CLIP
THAT DESCRIBES THE PROGRAM.
REMEMBER THAT THESE SLIDES ARE
ALL AVAILABLE TO ANYONE WHO'S
WATCHING THIS EVENTUALLY,
PUBLICLY.
NEXT SLIDE.
OKAY, SO IN THE NEXT PART, I
WANTED--WE HAVEN'T REALLY TALKED
ABOUT THIS EXCEPT MAYBE
INDIRECTLY AND AS I THOUGHT
ABOUT WHATEVER WE WANT TO
HIGHLIGHT WITH THIS ADVISORY
COUNCIL MEETING, I THINK IT'S
VERY IMPORTANT FOR YOU TO BE
AWARE OF WHERE OUR EFFORTS ARE
GOING TOWARDS MULTIPLE NIH WIDE
PROJECTS.
AND THIS IS SOMETHING THAT HAS
INCREASED DURING MY TIME AS
DIRECTOR, MY FIRST COUPLE YEARS,
WE WERE HARDLY INVOLVED IN
ANYTHING, AND NOW, IT'S
CLEARLY--IT'S AT LEAST 50% OF MY
TIME IF NOT MORE AS WELL AS
MULTIPLE STAFF MEMBERS WHO
DONATE THEIR TIME ESSENTIALLY TO
BE INVOLVED AND TO ADVOCATE FOR
OUR POPULATIONS AND TO BRING
THEIR EXPERTISE TO THE
DEVELOPMENT OF THESE PROGRAMS.
SO YOU ARE ALL AWORE OF N-PERC,
WHICH WAS START INDEED JUNE 2018
TO BRING TOGETHER PEDIATRIC
RESEARCH EXPERTISE AND AS AN
OPPORTUNITY TO COMMUNICATE WHAT
EACH INSTITUTE AND CENTER IS
DOING IN TERMS OF CHILD HEALTH
AND THE REASON FOR THIS IS NICHD
FUNDS--ORIGINALLY IT WAS 18%,
THE LAST NUMBERS I SAY WERE 16%
OF CHILDHOOD HEALTH RESEARCH
ACROSS NIH.
SO THERE'S 4 BILLION DOLLARS.
SO MORE THAN DOUBLE OF OUR
BUDGET IS BEING SPENT
COLLECTIVELY AT NIH ON CHILD
HEALTH RESEARCH, SO NEARLY EVERY
INSTITUTE OR CENTER HAS EQUITY
AND SPACE.
SO WE THOUGHT IT WOULD BE VERY
IMPORTANT TO BRING EVERYBODY
TOGETHER EVERY OTHER MONTH TO
DISCUSS WHAT'S GOING ON, AND
WHAT ARE THE PRIORITIES AND HOW
CAN WE WORK TOGETHER TO
REPRESENT CHILDREN, SO OUR
CURRENT FOCUS AREAS INCLUDE
DEVELOPMENT OF THE PEDIATRIC
RESEARCH WORKFORCE TO DEVELOP
AND REVERSE THE TREND OF
PEDIATRIC CLINICIAN SCIENTISTS
AND THEN I'LL TELL YOU IN A
MOMENT ABOUT PEDIATRIC MEDICAL
DEVICES, NEXT SLIDE, PLEASE.
SO THIS GROUP FORMED ORGANICALLY
BECAUSE THERE IS REALLY NO
GROWTH IN TERMS OF DEVICES THAT
ARE BEING DEVELOPED OR EVALUATED
FOR PEDEIAT INDICATIONS IN THE
UNITED STATES.
THERE ARE MULTIPLE CHALLENGES,
SO ETHICAL CONSIDERATIONS
REGARDING CARRYING OUT TRIALS IN
PEDIATRIC PATIENTS,
HETEROGEANIOUS NEEDS, MAYBE IT'S
QUITE DIFFERENT FROM ADOLESCENT.
YOU KNOW THE NEED FOR AN
EXPERIENCED CLINICAL TRIAL
INFRASTRUCTURE THAT IS FOCUSED
ON CHILD HEALTH RESEARCH.
UNCLEAR REGULATORY PATHWAYS AND
AN UNCLEAR RETURN ON INVESTMENT
SPECIFICALLY FOR CHILD HEALTH
RESEARCH AND A LACK OF TECHNICAL
INNOVATION FOR PEDIATRIC
SPECIFIC NEEDS.
SO THE IDEA IS THAT THE GROUP IS
WORKING TOGETHER TO IDENT
COLLABORATIVE PLATFORMS THAT
COULD PROPEL DEVELOPMENT OF
SOLUTIONS OR PARTICULAR
PROBLEMS, AND THEY'VE BEEN
WORKING EXTENSIVELY ON A
PROPOSED PUBLIC PRIVATE
PARTNERSHIP VIA THE FNIH TO
SUPPORT PEDIATRIC MEDICAL DEVICE
DEVELOPMENT AND
COMMERCIALIZATION.
SO THE FOUNDATION FOR NIH IS A
TRUSTED THIRD PARTNER THAT IS
ABLE TO COLLABORATE BETWEEN--OR
FACILITATE COLLABORATIONS
BETWEEN INDUSTRY AND THE NIH AND
IT WAS USED VERY EFFECTIVELY TO
TEST DRUGS TO TREAT COVID.
NEXT SLIDE.
OKAY, SO THE IMPROVE INITIATIVE,
I ALREADY MENTIONED THAT IN MY
VERY EARLIEST REMARKS, REGARDING
MATERNAL HEALTH.
SO THE IMPROVE INITIATIVE IS NIH
WIDE.
IT SUPPORTS RESEARCH FOCUSED ON
BASICALLY PREVENTING MATERNAL
DEATHS AND IMPROVING HEALTH FOR
WOMEN BEFORE, DURING AND AFTER
DELIVERY WITH AN EMPHASIS ON
HEALTH DISPARITIES AND OTHER
DISPROPORTIONATELY AFFECTED
POPULATIONS FOR EXAMPLE, RURAL
PREGNANT WOMEN.
I HEARD MENTIONED THERE WAS THIS
APPROPRIATION OF $30 MILLION, SO
IT'S NIH WIDE BUT IT'S IN
NICHD'S BASED BUDGET SO WE HAVE
THE MONEY THIS YEAR AND THERE'S
BEEN A TREMENDOUS AMOUNT OF
ACTIVITY SINCE MARCH TO FRAME
THIS PROGRAM AND THE CO-CHAIRS
ARE DR. JANINE CLAYTON FROM THE
OFFICE OF RESEARCH AND WOMEN'S
HEALTH AND DR. COURTNEY ACKLAND
WHO IS REPRESENTING THE OFFICE
OF THE DIRECTOR.
THE EMPHASIS HERE IS REALLY ON
BUILDING A RESEARCH
INFRASTRUCTURE WITH COMMUNITY
ORGANIZATIONS.
RATHER THAN A TOP-DOWN APPROACH
FROM ACADEMIC CENTERS, THE IDEA
IS WE WILL BE BUILDING CERTAIN
COMMUNITY RELATIONSHIPS SOME OF
WHICH HAVE PARTNERSHIPS WITH
ACADEMIC CENTERS BUT IMPORTANTLY
WE ALSO HAVE A CHALLENGE THAT
WILL BE GOING ON WITH COMMUNITY
ORGANIZATIONS THAT HAVE NO
CONNECTION.
TO ACADEMIA AND THIS IS REALLY
TO HELP THEM BUILD
INFRASTRUCTURE SO THEY CAN BE
COMPETITIVE IN THE NEXT FISCAL
YEAR.
WE ALSO HAVE ANOTHER CHALLENGE
THAT WILL BE GOING ON TO DEVELOP
AND IMPLEMENT TECHNOLOGY THAT
CAN BE USED FOR MATERNAL HEALTH
AND MATERNITY CARE DESERTS SUCH
AS FIT BITS OR HOME BASED
TESTING, POINT OF CARE TESTING.
THERE'S ANOTHER EMPHASIS ON
TRANSLATION STUDIES TO TRANSLATE
TECHNOLOGY OR LESSONS LEARNED IN
THE COMMUNITY TO MATERNAL HEALTH
INTERVENTIONS.
AND WE WILL ALSO BE FUNDING A
CONNECT-A-THON THAT WILL CONNECT
ESSENTIALLY A LONGITUDINAL
HEALTH RECORD FOR THE PREGNANT
PERSON AND THE CHILD ACROSS
PREGNANCY AND FOLLOWING
POSTPARTUM SO WE HAVE
IMPLEMENTATION SUPPLEMENTS AND
WE ARE WORKING ON THE MATERNAL
HEALTH CENTERS OF EXCELLENCE
FUNDING OPPORTUNITY ANNOUNCEMENT
AND THERE'S A NOTICE OF SPECIAL
INTEREST THAT IS ALREADY OUT,
THE FUNDING ANNOUNCEMENTS WILL
BE OUT LATER ON ON SUMMER AND
DR. [INDISCERNIBLE] IS OUR POINT
QUESTION SO IF HAVE YOU
QUESTIONS YOU CAN COB TACT HER.
SHE WILL APEERP ON A LATER SLIDE
SO YOU WILL SEE HOW TO SPELL HER
NAME, BY THE WAY.
THE INCLUDE PROJECT, I'VE SPOKEN
ABOUT THIS PREVIOUSLY,
INVESTIGATORRING CO-CURING
CONDITIONS ACROSS THE LIFE SPAN
TO UNDERSTAND DOWNS SYNDROME.
THIS IS SOMETHING WE HAVE FUNDED
NOW SINCE 2018 COMING FROM
CONGRESS' INFUSION OF NEW MONEY
INTO DOWNS SYNDROME RESEARCH.
THERE ARE 3 COMPONENTS TO THIS
PROJECT ON THE RIGHT, THE
PURPLISH ONCE IS
TRANSFORMATIONAL PROGECS THESE
ARE RO-1S THAT ARE BASIC SCIENCE
ORIENTED THAT ARE NOT ONLY
STUDYING THE EFFECTS OF 3 COPIES
FROM SOME 21 BUT ALSO DOWN
STREAM EFFECTS ON THE REST OF
THE GENOME AND GREENP SCREEN
EXPRESSION, COMPONENT 2 IS IN
THE PEACH COLOR ON THE LEFT OF
THE THEN DIAGRAM THAT IS TO
DEVELOP A COHORT, SO 1 OF THE
PROBLEMS HAS BEEN THAT EITHER
PEOPLE WITH DOWN'S SYNDROME WERE
EXCLUDED FROM RESEARCH OR
INVESTIGATORS WERE NOT WORKING
WORKING TOGETHER TO ESTABLISH
LARGE COHORTS SO NOW SO NOW THIS
COMPONENT HAS BEEN RESPONSIBLE
FOR COLLABORATIONS AND THE PLAN
IS TO INCLUDE INDIVIDUALS WITH
DOWNS SYNDROME WITH EXISTING AND
FUTURE CLINICAL TRIALS SO THAT'S
THE GREEN ON THE RIGHT AND I
JUST GOT BACK FROM THE TRUST ME
2021 RESEARCH MEETINGS THAT WERE
HELD IN LONG BEACH CALIFORNIA
AND IT WAS QUITE VISIBLE, THE
EFFECTS OF THE INFUSION OF
$75 MILLION AND THE
APPROPRIATION AND PREVIOUS
YEARS.
SO WE HEARD A WHOLE SESSION ON
THE INCLUDE PROJECT AND I MET
MANY TRAINEES WHO ARE SUPER
ENTHUSIASTIC, PROBABLY WOULD NOT
HAVE GONE INTO THIS FIELD
WITHOUT THIS FUNDING.
THERE HAVE BEEN A NUMBER OF
WORKSHOPS AND SEMINAR SERIES ALL
OF WHICH ARE FOCUSED ON
ENHANCING RESEARCH FOR PEOPLE
WITH DOWNS SYNDROME AND AND
AWLINGS TO UNDERSTAND CONDITIONS
FOR WHICH PEOPLE WITH DOWNS
SYNDROME ARE EXCLUDED, SO PEOPLE
DON'T GENERALLY GET MYOCARDIAL
INFARCTIONS, THEY DON'T GET
SOLID TUMORS, WHY IS THAT?
WHY ARE THEY PROTECTED FROM
THAT?
WHY ARE THEY ALMOST EXCLUSIVELY
GETTING ALZHEIMER'S DISEASE FOR
EXAMPLE.
NEXT SLIDE, PLEASE.
AND I HAD AN OPPORTUNITY TO MEET
THE PEOPLE AT THE MEETING WHO
WERE RUNNING THE DATA HUB AND
THAT'S IN THE UPPER PHOTO BELOW
BECAUSE THAT'S MY RESEARCH
LABORATORY BECAUSE 1 OF MY AREAS
OF OWN RESEARCH LABORATORY IN
THE GENOME INSTITUTE IS PRENATAL
TREATMENTS FOR DOWN SYNDROME AND
THAT'S A WHOLE OTHER
CONVERSATION BUT THE DATA HUB IS
WORKING VERY WELL, THEY ALREADY
HAVE OVER 27,000 BIODATA
SPECIMENS, OVER 55 SPECIMENS OF
TARA BITES OF DATA FILES.
IT'S FREE, IT'S AN OPPORTUNITY
FOR ANYBODY WHO'S INTERESTED TO
PROBE THE DATA, USE THE DAILY
BASIS AT ESPECIALLY THE GENOMICS
DATA TO UNDERSTAND AGAIN, WHY
ARE PEOPLE DOWN SYNDROMES
PREDISPOSED TO CERTAIN
CONDITIONS BUT PROTECTED FROM
OTHER CONDITIONS, NEXT SLIDE,
PLEASE.
SO ANOTHER AREA WE'RE INVOLVED
IN IS NUTRITION RESEARCH AND
THERE HAS BEEN A 10 YEAR PLAN
THAT HAS BEEN PUBLISHED FOR NIH
NUTRITION RESEARCH.
OUR STAFF PARTICULARLY FROM THE
PEDIATRIC GROWTH AND NUTRITION
BRANCH AS WELL AS DAN BRIGHTON
WERE VERY INVOLVED IN THE
DEVELOPING OF THIS PLAN, YOU
WILL SEE IF YOU LOOK AT THE PLAN
THAT OUR INTERESTS IN
DEVELOPMENTAL ORIGINS OF HEALTH
AND DISEASE ARE REALLY CALLED
OUT.
THE IMPORTANCE OF NUTRITION
DURING PREGNANCY FOR EXAMPLE, IS
CALLED OUTED AND NICHD CO CHAIRS
THE NUTRITION ACROSS THE LIFE
SPAN IMPLEMENTATION GROUP.
SO AGAIN, A LOT OF NICHD STAFF
ARE INVOLVED IN THIS NIH WIDE
EFFORT.
SIMILARLY, THE PROGRAM ON
NUTRITION FOR PRECISION HEALTH
IS SUPPORTED BY MULTIPLE NICHD
STAFF, NEXT SLIDE, PLEASE.
AND NEXT TO LAST IS THE NIH
INITIATIVE ON CLIMATE CHANGE AND
HUMAN HEALTH.
SO AGAIN, THE PRESIDENT IS VERY
CONCERNED WITH CLIMATE CHANGE
AND IN HIS BUDGET, HE TALKED
ABOUT GIVING $100 MILLION TO
NIH--NIEHS FOR CLIMATE CHANGE
AND HUMAN HEALTH RESEARCH.
SO, THERE WAS A LOT OF ACTIVITY,
PLANNING, WHAT WOULD WE DO WITH
THAT MONEY AND I'M 1 OF 7
INSTITUTE AND CENTER DIRECTORS
WHO IS ON AN EXECUTIVE COMMITTEE
TO DEVELOP THE STRATEGY GOING
FORWARD WE HAD SOME GREAT PLANS,
WITH CONGRESS DECIDED NOT TO
APPROPRIATE THIS.
SO WE WERE VERY LUCKY TO
IMPROVE-OF BUT THEY DID AY
APPROPRIATE THE IMPROVE PROGRAM
BUT UNFORTUNATELY THEY DID NOT
APPROPRIATE IN PROGRAM BUT THE
GROUP HAS BEEN MEETING REGULARLY
AND WE HAVE IDENTIFIED AREAS OF
PRIORITIES AND NICHD IS
CONTRIBUTING TO SOME PILOT
FUNDING TO ALLOW SOME OF THE
EFFORTS TO MOVE FORWARD WITH THE
HOPE THAT THERE WILL BE AN
APPROPRIATION NEXT YEAR.
NEXT SLIDE, PLEASE.
AND AGAIN WE ARE INTERESTED
BECAUSE OUR POPULATIONINGS ARE
PARTICULARLY VULNERABLE TO
CLIMATE CHANGE, NEXT SLIDE.
AND HERE ARE FUNDING
OPPORTUNITIES AGAIN, YOU WILL
SEE THE SLIDES, THE NOSI, AS
WELL AS RESEARCH COORDINATING
CENTER THAT IS I THINK THE
APPLICATIONSIBLYICATIONS HAVE
ALREADY BEEN VIEWED FOR THAT.
NEXT SLIDE, PLEASE.
SO THE LAST INITIATIVE I WANTED
TO HIGHLIGHT IS HELPING TO END
ADDICTION CLONG TERM AND THIS
AGAIN ALSO STARTED AROUND 2017
AND WE HAVE BEEN VERY INVOLVED
FROM THE BEGINNING WITH THE
ADVANCING CLINICAL TRIALS IN
NEONATAL OPIOID WITHDRAWAL
SYNDROME.
SO ACT NOW AND AS A RESULT OF
THIS INITIATIVE, WE FOUND OUT
THAT THERE REALLY WASN'T A
STANDARD OF CARE THAT NICU
BABIES WERE BEING TREATED VERY
DIFFERENTLY IN DIFFERENT UNITS,
AND THERE WERE THERE WERE
CERTAIN EFFORTS OR APPROACHES TO
TREATMENT HA HAD NEVER REALLY
UPDATER GONE A PROSPECTIVE
CLINICAL TRIAL, SO 1 OF THE
TRIALS THAT WAS FUNDED IS THE
EAT, SLEEP AND CONSOLE CLINICAL
TRIAL IN WHICH BABIES ARE NOT
MEDICATED WITH OPIOIDS AS PART
OF THEIR WITHDRAWAL.
THEY'RE ALLOWED TO EAT
CONTINUOUSLY, SLEEP CONTINUOUSLY
AND THERE ARE BABY HUGGERS IN
THE NICU THAT ARE CONSOLING THE
BABIES.
THIS STUDY DOES EXCEPTIONALLY
WELL.
THE ENROLLMENT WAS ABOUT 150% OF
WHAT WAS EXPECTED.
THE OTHER STUDY THAT HAS BEEN
GOING ON IS REALLY LOOKING AT
CAN YOU WEAN INFANTS OFF OPIOIDS
QUICKLY VERSUS IN A MORE
PROLONGED FASHION BECAUSE BABIES
THAT ARE BEING WEANED SLOWLY ARE
TAKING UP NICU BEDS APPROXIMATE
AND ARE COSTING THE HEALTHCARE
SYSTEM A CONSIDERABLE AMOUNT
WHEN IT REALLY ISN'T CLEAR THAT
IT NEEDS TO BE DONE THAT WAY.
THAT STUDY IS STILL ENROLLING
AND AT LEAST 50% OF EAT, SLEEP
AND CONSOLE COHORT IS--HAS BEEN
ENROLLED INTO LONGITUDINAL
FOLLOW UP STUDIES AS WELL.
WE'RE ALSO INTERESTED PREGNANT
PEOPLE WHO HAD CAESAREAN SECTION
DELIVERIES AND WE HAD THE PACT
TRIAL, PRESCRIPTION AFTER
CAESAREAN SECTION WHICH IS
LOOKING AT OPIOIDS AS NEEDED
VERSUS OLD REGIMEN OF OPIOIDS
AND THIS WAS AN IMPORTANT STUDY
BECAUSE SO MANY WOMEN DO GET
CAESAREAN DELIVERIES AND AN
EXTRAORDINARY NUMBER OF WOMEN
BECAME ADDUCTED TO OPIOIDS
BECAUSE THEY WERE FIRST
INTRODUCED TO THEM AS A RESULT
OF PAIN TREATMENT VERSUS
CAESAREAN SECTION, SO WE HOPE TO
HAVE THAT STUDY DONE AND HAVE
ANSWERS SOON AND THEN WE EXPECT
OR WE HOPE THAT THERE WILL BE A
NEW FUNDING OPPORTUNITY ON
OPIOID EXPOSURE AND EFFECTS ON
PLACENTAL FUNCTION, BRAINMENT
AND NEURODEVELOPMENT OUTCOMES
AND SO THAT CONCEPT WILL BE
REVIEWED IN THIS CYCLE OF
COUNCILS, AND THEN JUST BRIEFLY
THE BRAIN INITIATIVE WHICH HAS
BEEN GOING ON FOR A NUMBER OF
YEARS, BRAIN IS AN ACRONYM FOR
NIH BRAIN RESEARCH THROUGH
ADVANCING INNOVATIVE
NEUROTECHNOLOGIES AND IT ALSO
HAS AN ASSOCIATED PROGRAM CALLED
THE BLUEPRINT FOR NEUROSCIENCE
RESEARCH.
SO AGAIN NICHD STAFF IS INVOLVED
WITH MANY BRAIN AND BLUEPRINT
WORKING GROUPS THAT ARE RELEVANT
TO PARTICULARLY OUR CHILD
DEVELOPMENT AS WELL AS
STRUCTURAL BIRTH DEFECTS,
PRIORITIES, THE NIH INFANT AND
TODDLER TOOL BOX WHICH IS A
SERIES OF ASSAYS DESIGNED TO
STUDY DEVELOPMENT IN A YOUNGER
AGE POPULATION IS FUNDED BY
THESE PROGRAMS AND THE FIRST
ROUND OF VALIDATION STUDIES HAS
BEEN SUCCESSFULLY COMPLETED AND
NEW MEASURES WERE ADDED THIS
PAST YEAR FOR VISUAL RECEPTION
AND SWAY AND BALANCE.
JOHN NAI IS THE DIRECTOR OF
BRAIN AND HE WRITES A BLOG ON
WHAT IS THE U.S. GET FIGURE
THEIR MONEY AND INVESTMENTS AND
BRAIN AND HERE IT IS AND THERE
HAVE BEEN SOME--THIS HAS BEEN AN
ENORMOUSLY PRODUCTIVE PROGRAM
WHERE YOU KNOW REALLY
TRANSFORMATIVE RESEARCH HAS BEEN
DONE SINCE CENSUSES, CENSI,
ATLASS OF MAMMALIAN BRAINS,
SINGLE CELL STUDIES IN THE MOUSE
FOR EXAMPLE, AND APPROACHES TO
ELECTRICAL BRAIN STIMULATION AND
NEUROSTIMMULATION.
SO THIS IS A VERY BIG PROGRAM
AND WE'RE VERY GRATEFUL THAT OUR
STAFF ARE INVOLVED.
IN FACT, TERESA CRUISE WHO IS
THE DIRECTOR OF NCMRR IS THE CO
CHAIR OF THE TEAM B IN THE BRAIN
INITIATIVE AND SO THAT ACTUALLY
ACCOUNTS FOR A SIGNIFICANT
PERCENTAGE OF EFFORT AND WE'RE
GRATEFUL FOR THAT.
SO I'M TIRED OF JUST TALKING
ABOUT IT SO CAN YOU IMAGINE THIS
IS A LOT OF EFFORT ON THE PART
OF EVERYONE.
I'M GOING TO CLOSE BY TELLING
YOU FINALLY, WE HAVE SOME HIRES
TO SHARE WITH YOU.
SO YOU WILL SEE DR. HAZRA, ON
THIS VIDEOCAST.
HE IS THE DIRECTOR OF THE
DIVISION OF EXTRAMURAL RESEARCH,
YOU KNOW HIM PREVIOUSLY BECAUSE
HE WOULD PRESENT ON BEHALF OF
THE MATERNAL AND PEDIATRIC
DISEASE BRANCH AND THEN HE
SERVED VERY WELL AS ACTING
DIRECTOR FOR 2 YEARS.
HE IS NOW THE CHOSEN 1 AND HE IS
HARD AT WORK.
YOU WILL HEAR MORE FROM HIM.
WE HAVE A BRAND THIEW PERSON TO
NICHD AND THAT'S DR. REBE
KA RASOOLY, WHO HAS BEEN
APPOINTED SELECTED AS OUR NEW
DIRECTOR OF EXTRAMURAL
ACTIVITIES THAT IS A NEW OFFICE
THAT IS OVERSEEING THE NICH DID
D REVIEW AND MANAGEMENT GRANTS
BRANCH AND ALSO DR. RASOOLY IS
OVERSEEING AND CREATING POLICY
FOR A NUMBER OF THINGS THAT
TOUCH ALL ASSPECS OF THE
EXTRAMURAL ENVIRONMENT AS WELL
AS TRAINING AND SHE HAS WORKED
IN A NUMBER OF DIFFERENT
INSTITUTESSA THE IN, IH, SHE HAS
A BACKGROUND AS A GENETICIST,
BUT SHE BRINGS EXPERTISE
ACQUIRED FROM A NUMBER OF
DIFFERENT INSTITUTES INCLUDING
NIDDK AND NINR AND I BELIEVE ARE
OTHERS AS WELL.
SO WE ARE DELIGHTED TO HAVE HER
AND WELCOME HER.
NEXT SLIDE.
IF WE WERE IN PERSON, WE WOULD
HIGHLIGHT HER.
>> YOU HEARD ME MENTION
DR. [INDISCERNIBLE], THIS IS HOW
SHE SPELLS HER NAME AND WE HAVE
APPOINTED HER AS THE CHIEF OR
PREGNANCY PERIINATOLOGY BRANCH.
WE WOULD LIKE TO THANK
[INDISCERNIBLE] FOR MULTIPLE
YEARS OF SERVICE IN THE ACTING
ROLE FOR THIS BRANCH.
NAHIDA IS AN OBSTETRICS
SPECIALIST IN GUIN COALING, SHE
WAS PREVIOUSLY A MEDICAL OFFICER
AND PHYSICIAN WITH THE PEDIATRIC
AND INFECTIOUS DISEASES BRANCH,
SHE HAS BEEN VERY INVOLVED IN A
LOT OF OUR INTERNAL HEALTH
INITIATIVES.
SO BETWEEN ROHAN'S PROMOTION TO
DIRECTOR OF DER, THAT CREATES A
NEW BRANCH CHIEF OPENING IN THE
MATERNAL AND PEDIATRIC INFECT
YOWZ DISEASE BRANCH.
LISA HALVERSON IN INDUSTRY SO WE
HAVE A BRANCH CHIEF HOPING IN
GYNECOLOGIC AND HEALTH DISEASE,
AND LOU RETIRED AFTER MANY YEARS
OF IN, ICHD CREATING AN OPENING
FOR THE CHIEF OF THE FER TELLITY
AND INFERTILITY BRANCH.
SO WE HAVE OPPORTUNITIES TO
BRING IN NEW PEOPLE, NEXT SLIDE.
AND THEN IN THE DIVISION OF
INTRAMURAL RESEARCH WE HOPE TO
HAVE A SCIENTIFIC DIRECTOR
SELECTED BY THE NEXT COUNCIL
MEETING.
WE'VE HAD 4 EXCELLENT FINALS, WE
ARE STILL WORKING THROUGH ALL
THAT.
SINCE THE LAST COUNSEL MEETING
WE HAVE OPENED A SEARCH FOR A
NEW CLINICAL DIRECTOR DENNY
PORTER WHO WAS OUR CLINICAL
DIRECTOR FOR 12 YEARS DECIDED IT
WAS TIME TO STEP DOWN AND HE
WANTED TO DO THAT BEFORE A NEW
SCIENTIFIC DIRECTOR WAS
APPOINTED WE HAVE FORMED A
RESEARCH COMMITTEE AND I
AAPPOINTED THEM AND IT IS NOW
OPEN ON JUNE 1st AND IF ANYONE
NEEDS INFORMATION ON THAT, I CAN
GIVE YOU THE LINK AND THIS IS A
VERY IMPORTANT POSITION BECAUSE
CURRENTLY THE CLINICAL RESEARCH
STRATEGIC PLAN FOR PEDIATRIC
RESEARCH IS ABOUT TO BE
REFRESHED AND THIS IS AN
OPPORTUNITY TO TAKE A LOOK AT
THE TYPES OF CLINICAL RESEARCH.
PROJECTS WE HAVE IN OUR
INTRAMURAL BRANCH AND REALLY
HELP US TO ALIGN RESEARCH WITH
OUR OVERRAL STRATEGIC INSTITUTE
PLAN.
I THINK THAT'S ABOUT IT, IT'S A
LOT OF INFORMATION.
NEXT SLIDE, I BELIEVE NEXT
SLIDE'S THE LAST 1 SO I WANT TO
THANK YOU FOR YOUR ATTENTION.
WE CAN TAKE THE SLIDES DOWN AND
HOPEFULLY WE HAVE SOME TIME FOR
QUESTIONS.
WE KIND OF STARTED 7 MINUTES
LATE, SO, DENNIS CAN WE HAVE THE
7 MINUTES FOR QUESTIONS?
I SEE QUESTIONS POPPING UP.
YOU'RE FIRST.
>> THANK YOU, MY QUESTIONS
RELATE TO THE [INDISCERNIBLE]
AND I WOULD LIKE TO KNOW WHAT
ARE THE PLANS OF HOW NIH CAN GET
INVOLVED WITH OTHER FEDERAL
AGENCIES?
BECAUSE THIS IS A BIG
OPPORTUNITY FOR EXAMPLE, FOR
DARPA, TO INCLUDE THE RECENT
DISCOVERY OF WHAT
[INDISCERNIBLE] IS DO SUGGEST TO
RECRUIT ENGINEERS NORMALLY
FUNDED BY NSF AND DARPA TO BRING
THEIR KNOW-HOW, THEIR CENTERS
AND THEIR CAPABILITIES TO
PROMOTE THESE GREAT INITIATIVE.
THANK YOU.
>> THANKS FOR THAT GREAT
SUGGESTION.
I MEAN, [INDISCERNIBLE] IS SORT
OF A CLEARINGHOUSE OR
OPPORTUNITY FOR OUTSIDE EXPERTS
OR INVESTIGATORS TO INTERACT
WITH ALL OF THE SENIOR CHILD
HEALTH REPRESENTATIVES OF EACH
INSTITUTE AND CENTER, I KNOW
THAT WE'VE HAD PRESENTATIONS
FROM OTHER FEDERAL AGENCIES,
FOLKS FROM CDC FOR EXAMPLE, I
DON'T KNOW FROM NSF OR DARPA BUT
THOSE ARE AREAS WE CAN CERTAINLY
LOOK INTO AND ESTABLISH MORE
RELATIONSHIPS WITH THEM OR AT
LEAST ORIENT THEM TO WHAT WE'RE
TRYING TO ACHIEVE BUT WE DO--WE
HAD FOR EXAMPLE, PRESENTATION
FROM ACADEMIC FOLKS ON HOW WE
CAN ALL WORK TOGETHER TO SUPPORT
TRAINING OPPORTUNITIES TO
INCREASE THE PEDIATRIC RESEARCH
WORKFORCE.
SO WE DO COLLABORATE WITH OTHER
AGENCIES BUT NOT THE 2 TO MY
KNOWLEDGE THAT YOU MENTIONED BUT
WE CAN CERTAINLY EXTEND A
WELCOME TO THEM AND SEE WHERE
THERE ARE AREAS FOR SHARED
INTEREST.
>> THANK YOU.
>> I HOPE THAT ANSWERS YOUR
QUESTION.
>> YES, THANK YOU.
I WILL BE HAPPY TO PROVIDE SOME
LINKS TO CENTERS AND TO PROGRAM
DIRECTORS, WE WOULD BE EXCITED
ABOUT THESE COLLABORATIONS.
>> THAT WOULD BE GREAT, WE WOULD
APPRECIATE THAT.
I THINK KATHRYN WAS NEXT.
AND ALSO ROHAN IS PUTTING IN
SOMETHING IN GENERAL ABOUT NIH
AND NSF IN THE CHAT BOX BUT
LET'S GO TO KATHRYN AND I KNOW
THERE ARE A NUMBER OF QUESTIONS
IN THE CHAT BOX.
>> SO THIS IS A SENSITIVE ISSUE
AND I WILL TRY TO PHRASE IT AS
CORRECTLY AS I CAN BUT WE ARE
POTENTIALLY ABOUT TO 'EM BARK ON
A NATIONAL NATURAL EXPERIMENT
RELATED TO MATERNAL HEALTH AND
INFANT HEALTH AND I'M WONDERING,
THAT'S GOING TO VARY ACROSS
STATES AND I'M WONDERING IF
THEY'RE ENCOURAGING NICHD ABOUT
HOW WE MIGHT CAPTURE DATA ABOUT
WHAT HAPPENS WITH THESE
POTENTIAL NATURAL EXPERIMENTS SO
THAT WE CAN BE ADVOCATING FOR
MATERNAL AND FETAL HEALTH GOING
FORWARD.
>> SO THANK YOU IF ARE THAT
QUESTION, WHEN YOU SAY NATURAL
EXPERIMENT, ARE YOU REFERRING TO
COVID?
>> NO, I'M REFERRING TO THE
SUPREME COURT AND THE LAWS THAT
ARE BEING PASSED.
>> OKAY, OKAY.
>> YES.
YES.
THERE WILL BE CERTAIN THINGS
THAT I BELIEVE THE CDC WILL BE
CAPTURING VITAL DATA BUT WE WILL
PROBABLY TALK ABOUT A LOT OF
THOSE ISSUES TOMORROW IN THE
CLOSED SESSION SO WE CAN HOLD
THAT QUESTION, IT WILL
DEFINITELY AFFECT A NUMBER OF
AREAS FOR OUR RESEARCH SO WE
WOULD LIKE TO HAVE A DISCUSSION.
I'M GOING TO GO TO THE OTHER
PEOPLE WHO PUT THINGS IN THE
CHAT BOX AND THEN SO SHERRY
WANTED TO KNOW WHAT ARE WE DOING
ABOUT MENTAL HEALTH INITIATIVES?
AND WE'RE VERY CONCERNED ABOUT
YOUTH MENTAL HEALTH FOR SURE.
NIMH IN GENERAL IS THE LEAD ON
YOUTH MENTAL HEALTH ISSUES.
WE ARE CO FUNDING A NUMBER OF
INITIATIVES WITH THEM AND THERE
ARE AREAS FOR EXAMPLE IN OUR
CHILD DEVELOPMENT AND BEHAVIOR
BRANCH THAT ARE ADDRESSING SOME
OF THESE ISSUES BUT WE RECOGNIZE
THAT YOU KNOW THAT MAY BE THE
MOST SIGNIFICANT LONG-TERM
COMPLICATION OF COVID, ALTHOUGH
IT WOULDN'T NECESSARILY BE
THOUGHT OF AS LONG ASHING, IT IS
AN INDIRECT EFFECT OF THE
PANDEMIC OF CHANGE SOCIAL
RELATIONSHIPS, OF ISOLATION, NOT
BEING IN SCHOOL, NOT BEING ABLE
TO SEE YOUR FRIENDS AT CERTAIN
TIMES, SO IT'S VERY MUCH ON OUR
RADAR SCREEN.
BUT IT IS--YOU KNOW NIMH IS THE
PRIMARY INSTITUTE FOR THAT TYPE
OF WORK.
I DO SEE THAT ANTENELLO HAS PUT
IN A NOTICE REGARDING THE
PEDIATRIC MEDICAL DEVICE
INITIATIVE THAT I TALKED ABOUT
IN THE CHAT BOX AND ROHAN PUT IN
A LINK TO COLLABORATION BETWEEN
NIH AND NSF.
SO THAT BRINGS ME TO LUCKY.
LUCKY DO YOU WANT TO UNMUTE
YOURSELF?
>> SURE.
I WANTED TO CONGRATULATE YOU FOR
THE 3 SENIOR RECRUITMENTS THAT
YOU ANNOUNCED TODAY.
I DO BELIEVE THAT DR. ROHAN AND
DR. NEJADA, ARE OUTSTANDING
CHOICES FOR THESE IMPORTANT
LEADERSHIP ROLES WITHIN THE NICH
D AND I JUST WANTED TO MAKE SURE
THAT ON BEHALF OF THE COUNCIL WE
CONGRATULATE YOU FOR THESE--FOR
THESE IMPORTANT APPOINTMENTS AND
AUSCONGRATULATE YOU FOR THIS
OUTSTANDING REPORT THAT YOU
PRESENTED.
THANK YOU.
>> THANK YOU VERY MUCH, LUCKY,
THAT'S REALLY WONDERFUL TO HEAR.
YES, WE ARE EXTREMELY GRATEFUL
THAT WE'RE ABLE TO RECRUIT ALL
OF THESE PEOPLE, WE'VE ACTUALLY
REKRIETED A SIGNIFICANT NUMBER
OF PEOPLE IN THESE AREAS AS WELL
SUCH AS ARE BECKA ROSEN CHO IS
THE DIRECTOR OF OUR NEW OFFICE
OF DATA SCIENCE AND SHARING.
YOU KNOW I WOULD LIKE TO GET
THESE D. I. R. RECRUITMENTS
FINALIZED, THAT WOULD BE HELPFUL
AND WE DO HAVE A NEW LEADERSHIP
OPPORTUNITY IN OUR OFFICE OF
HEALTH EQUITY.
SO A LOT OF--A LOT OF RECRUITING
GOING ON AT A TIME WHEN PEOPLE
ARE RESIGNING OR RETIRING OR
WHATEVER, BUT I DO WANT TO
MENTION THAT NIH HAS INCREASED
FLEXIBILITY IN TERMS OF OPTIONS
TO WORK REMOTELY AND TO WORK
UNDER MAX NUM TELEWORK OPTIONS.
SO UNLESS YOU'RE--IF YOU'RE THE
CLINICAL DIRECTOR, YOU NEED TO
BE IN THE HOSPITAL, BUT IF YOU
ARE A PROGRAM OFFICIAL OR
MEDICAL OFFICER, WE HAVE
INCREASED FLEXIBILITY IN TERMS
OF NEEDING TO WORK FROM HOME
EVEN IF YOU LIVE IN ANOTHER
STATE, IN ANOTHER TIME ZONE.
SO LET'S SEE, PEPE, I WILL
ASSUME YOU ASKED YOUR QUESTION
AND YOU HAVE A LEGACY HAND BUT
I'M GOING TO GO TO MARTIN AND
THEN TONY.
>> DIANEA THANK YOU VERY MUCH
FOR THE NICE UPDATE AND
CONGRATTULESS ON THE INCREASE IN
THE NIH BUDGET.
I JUST HAD A QUESTION GOING
FORWARD INTO THE NEXT FISCAL
YEAR.
AS YOU KNOW A LOT OF FUNDS HAVE
GONE INTO COVID RELIEF AND ALSO
THERE'S A LOT OF FUNDS THAT ARE
GOING TOWARDS THE WAR WITH IN
UKRAINE WITH RUSSIA AND SO THE
QUESTION YOU KNOW DO YOU HEAR
ANY RUMORS ABOUT HOW THAT WILL
INFLUENCE YOUR BUDGET, THE NIH
BUDGET IN THE NEXT FISCAL YEAR.
>> YEAH, I MEAN, THERE ARE
ALWAYS RUMORS BUT I CAN--I CAN
CERTAINLY SHARE WHAT I HEARD
FIRST HAND AT THE CONGRESSIONAL
HEARINGS, AND THE HOUSE
APPROPRIATIONS SUBCOMMITTEE WERE
ENORMOUSLY SUPPORTIVE OF THE
WORK WE DO AND THAT WAS REALLY
BIPARTISAN.
A LOT OF THE QUESTIONS THEY
ASKED ABOUT ARP A H WERE
NOT--THEY WERE REALLY ASKING WHY
ARE WE GIVING MONEY TO ARP A-H,
WHEN IT DOESN'T EXIST YET, WE
WOULD RATHER GIVE THE MONEY TO
NIH SO IT WAS A PRETTY FEEL GOOD
SESSION AND EVERYBODY FELT IT
WAS MORE SUBSTANTIVE THAN
PREVIOUS SESSIONS THAT MAYBE HAD
FOCUSED EBS CLUESIVELY ON COVID
AND THERE WERE CERTAIN POLITICAL
SENSITIVITIES, THIS TIME THE
QUESTIONS WERE MUCH MORE FOCUSED
ON BIG PICTURE ISSUES WHICH WAS
GOOD.
YOU KNOW WE'RE UNDERGOING A LOT
OF CHANGES AT THE TOP AS WELL, I
MEAN, I JUST KNOW FROM READING
THIS MORNING IT APPEARS
DR. COLLINS WAS QUOTED AS SAYING
THAT WE'RE WEEKS AWAY FROM
NAMING A NEW NIH DIRECTOR.
WE DON'T KNOW WHO THAT IS.
--WE NEVER REALLY GOT THE
BENEFIT OF A HUGE AMOUNT OF
THOSE FUNDS.
WE GOT SOME OF THE FUNDS FOR
WHICH WE COMPETED BUT THE FUNDS
WERE APPROPRIATED TO THE OFFICE
OF THE DIRECTOR, SO WE WON'T--IF
THE SPIKET FOR COVID IS TURNED
OFF, IT REALLY WON'T AFFECT US
THAT MUCH DIRECTLY.
IT'S REALLY CRUCIALLY IMPORTANT
FOR CONGRESS TO KNOW WHAT WE DO
AND WHAT IS OUR SPACE IN THE NIH
ECOSYSTEM AND WHERE CAN WE
CONTRIBUTE.
THAT'S WHY, PUTTING THE IMPROVE
MONEY INTO THE NICHD BASE WAS
REALLY IMPORTANT BECAUSE IT
SHOWED THAT CONGRESS RECOGNIZED
THAT NICHD, FUNDS 45% OF
MATERNAL HEALTH RESEARCH.
SO WE HAVE MORE EQUITY IN
MATERNAL HEALTH SPACE THAN WE DO
IN CHILD HEALTH SPARE, SO I
DON'T HAVE ANYTHING NEGATIVE
THAT'S AGAINST THE BACKGROUND OF
ALL THE OTHER THINGS THAT ARE
GOING ON, PARTICULARLY THE
POSSIBILITY OF ECONOMIC CHANGES
BUT I CAN TELL YOU HONESTLY THAT
CONGRESS IS VERY SUPPORTIVE OF
WHAT THE NIH DOES.
>> GREAT.
THANK YOU.
>> SO WE WILL TAKE TONY AND THEN
WE WILL MOVE ON.
>> THANK YOU, I WILL SAY HOW
MUCH I APPRECIATE THE OVERVIEW
AND THE GREAT WORK BEING DONE, I
WAS NOT TO MAKE A COMMENT,
PERHAPS EERVE A PLEA ON THE
BRAIN INITIATIVE, BECAUSE SO
MANY THINGS HAPPEN DURING BRAIN
DEVELOPMENT AND CHILD HEALTH
INTUITY IS THE 1 THAT HAS TO BE
INVOLVED INTERNATIONAL
CLASSIFICATION PLATELY IN ALL
THE FETAL DEVELOPMENTAL TIME
POINT, THE CHILDHOOD
DEVELOPMENTAL TIME POINT UP
THROUGH ADOLESCENCE IS WHEN IT'S
OCCURRING AND I'M HOPING THE
INVOLVEMENT WHICH IS CERTAINLY
HAPPENING IS ALSO INVOLVED IN
LEADING THOSE SORTS OF EFFORTS
IN THE BRAIN INITIATIVE TO MAKE
SURE THAT WE UNDERSTAND SO MUCH
MORE ABOUT THE DEVELOPMENTAL
ABNORMALITIES THAT ARE GOING ON
AS WELL AS NORMAL DEVELOPMENT
THROUGH THE HUMAN BRAIN.
SO THANKS IF ARE THAT COMMENT.
I WOULD SAY THAT JOHN NG AI, THE
NEW DIRECTOR OF BRAIN IS MUCH
MORE RESENTIVE TO DEVELOPMENTAL
NEUROSCIENCE THAN PERHAPS OTHER
PEOPLE BEFORE MY TIME.
THERE ARE MULTIPLE INSTITUTES
AND CENTERS THAT ARE INTERESTED
IN TYPICAL AND ATYPICAL BRAIN
DEVELOPMENT SO NIDA FOR EXAMPLE
IS THE LEAD INSTITUTE FOR THE
HEALTHY BRAIN.
SO THAT'S WHY YOUR POINT IS
TAKEN,Y ESPECIALLY IN LIGHT OF
WHAT I SAID WITH THE PAPER THAT
CAME OUT FRIDAY IN JAMA
NETWORKOT DIFFERENCES IN 1
YEAR-OLDS WHO WERE FETUSES
EXPOSED TO COVID-19 IN THE WOMB
INDIRECTLY.
SO, YOU KNOW MY BIGGEST FEAR IS
THAT 5 YEARS FROM NOW, WE WILL
SEE SOME SORT OF INCREASE IN
NEURODEVELOPMENTAL DISORDERS AS
A RESULT OF COVID AND MAYBE
THERE WILL BE SUBTLE AND MAYBE
YOU WON'T SEE THEM UNTIL KIDS GO
TO KINDERGARTEN BUT IT IS
SOMETHING TO BE LOOKING OUT FOR.
>> WELL THAT'S JUST A GREAT
EXAMPLE, TOO OF WHY NICHD SHOULD
BE INTIMATELY INVOLVED BECAUSE I
THINK THAT ALTHOUGH ALL THESE
OTHER INSTITUTES THAT YOU TALKED
ABOUT ARE INTERESTING IN BRAINED
DEVELOPMENT, I DON'T THINK ANY
OF THEM ARE REALLY THINKING
ABOUT IT AS BEING PART OF A
MATERNAL-FETAL UNIT AND MEN AND
WOMEN'S HAPPENING DURING
CHILDHOOD SO I JUST THINK YOUR
INSTITUTES INVOLVEMENT IS SO
CRITICAL IS AND I THINK IT'S
REALLY IMPORTANT THAT'S ALL,
THANKS.
>> YEAH, THANK YOU SO THERE ARE
QUITE A LOT OF RESOURCES THAT
ARE BEING PUT UP IN THE CHAT BOX
SO I ENCOURAGE EVERYONE TO TAKE
A ELECTRIC AT THAT.
BOTH REFERENCES AND ALSO ANOTHER
LINK TO AN NIH COLLABORATION, I
SHOULD HAVE THOUGHT OF THAT
BECAUSE I JUST SIGNED IT
YESTERDAY, THE M. O. U. BUT
THANK YOU FOR PUTTING THAT IN
THERE.
SO I THINK PROBABLY TO STAY MORE
OR LESS ON TIME, WE JUST ULS
WANT TO ACKNOWLEDGE AMANDATORY
PRICE'S WORK FROM THE CHILD
DEVELOP EXPMENT BEHAVIOR BRANCH.
SHE HAS BEEN REALLY ADVOCATING
FOR A DEVELOPMENTAL FOCUS TO
SOME OF THE BRAIN WORKSHOPS
INCLUDING BRAIN DEVELOPMENT
ACROSS THE LIFE SPAN WHICH WAS
THE RECENT WORKSHOP CALLED IN
COLLABORATION WITH THE GATES
FOUNDATION.
YEAH, SO THAT'S EXACTLY WHAT I'M
WORRIED ABOUT, SHERRY IS AUTISM
AND SCHIZOPHRENIA.
SO DON'T WANT TO BE DEBBIE
DOWNER, SO I DO WANT TO NOW PASS
THE MEETING OVER TO MISS ALEXIS
CLARK WHO IS NIH'S BUDGET
OFFICER OR DIRECTOR OF THE
BUDGET OFFICE.
THIS WAS 1 OF THE HIGHLIGHT
PRESENTATIONS WHICH I WAS IN
COUNCIL.
ALEXIS IS GREAT AND SHE IS GOING
TO TAKE YOU THROUGH BUDGET 101.
>> THANK YOU DR. BIANCHI, NO
PRESSURE.
[LAUGHTER]
I HOPE EVERYBODY CAN HEAR ME
OKAY.
>> YES.
>> GREAT.
THANK YOU SO AS DR. BIANCHI,
SAID, I AM ALEXIS CLARK, I AM
THE BUDGET OFFICER FOR NICHD
WHICH IS SORT OF AN NIH TITLE
FOR EACH IC, WHO DIRECTS THE
BUDGET OFFICE.
I'VE BEEN AT NICHD SINCE 2010
SO, COME BEING UP ON CLOSING
OUT, I GUESS THE 12th YEAR SO
IT'S BEEN A LONG TIME BUT IT'S
GONE VERY QUICKLY.
SO I AM HAPPY TO TALK TO YOU
TODAY ABOUT THE BUDGET,
HOPEFULLY, GIVE YOU SOME
INFORMATION.
NEXT SLIDE, PLEASE.
WE WILL TALK A LITTLE BIT ABOUT
JUST THE FEDERAL BUDGET PROCESS
WHICH DR. BIANCHI HAS TOUCHED ON
IN HER PRESENTATION, THE BUMET
AT NIH, THE MECHANISM TABLE AND
SOME OFURE OOPS AM I STILL
THERE, HELLO?
OKAY, I HAD WEIRD DINGS IN MY
EARS, SO SORRY ABOUT THAT AND
SOME OF OUR MANDATED PROGRAMS.
WE WILL TALK ALSO ABOUT GRANT
BUDGETS, ALLOCATIONS, PAY LINES
WHICH I KNOW FOLKS ARE ALWAYS
INTERESTED IN HOW WE COME UP
WITH THOSE, PARTICULARLY AS IT
COMES TO RESEARCH PROJECT GRANTS
LIKE THE R01s, AND SIDEWALK
ABOUT THE SET ASIDES WE HAVE AND
OF THE OTHER GRANT MECHANISMS AS
WELL.
NEXT SLIDE, PLEASE.
>> SO THE FEDERAL BUDGET PROCESS
IS A LONG 1.
YOU KNOW RIGHT NOW AGENCIES ARE
WORKING ON DEVELOPING OUR BUDGET
REQUESTS FOR THE FY24
PRESIDENT'S BUDGET AND AS
DR. BIANCHI TOUCHED ON THE FY23
PRESIDENT'S BUDGET WHICH WAS
JUST RELEASED IN MAY, THE
PRESIDENT'S BUDGET CONTAINS
PROPOSALS TO CONGRESS WHICH
CONGRESS MAY CHOOSE TO ENACT OR
NOT AND WE PUT THOSE PROPOSALS
TOGETHER IN THE CONGRESSIONAL
JUSTIFICATION WHICH
TRADITIONALLY IS SENT TO
CONGRESS ON THE FIRST MONDAY IN
FEBRUARY.
WE HAVE APPROPRIATIONS HEARINGS
IN THE SPRING SUCH AS THOSE
DR. BINCHI PARTICIPATE INDEED
AND THE COMMITTEES WO, ON THE
APPROPRIATION IN THE UMKCER.
THE GOAL IS FOR CONGRESS TO
APPROPRIATE FUNDS BY
OCTOBER 1st.
SADLY, THAT DID NOT HAPPEN VERY
OFTEN.
WHEN THAT DOES NOT HAPPEN, WE
HAVE WHAT IS CALLED A CONTINUING
RESOLUTION OR A CR.
AND A CR HAS HAPPENED EVERY YEAR
FROM 1997-2019.
SO THAT WILL TELL YOU HOW RARE
THESE ARE.
WE HAVE HAD CONTINUING
RESOLUTIONS AGAIN, THE LAST
COUPLE YEARS, A CONTINUING
RESOLUTION JUST GIVES US PARTIAL
FUNDING TO KEEP US MOVING WHILE
CONGRESS TRIES TO FINISH THEIR
WORK.
IT GIVES US BASICALLY
PROPORTIONATE FUNDING AND IT CAN
LAST ANYWHERE FROM A FEW DAYS TO
A FULL YEAR.
NEXT SLIDE, PLEASE.
SO NOW WE WILL TALK A LITTLE BIT
MORE SPECIFICALLY ABOUT BUDGET
AT THE NIH.
NEXT SLIDE.
SO, AT NIH, IN THE--IN THE NIH
OFFICE OF THE DIRECTOR, THERE IS
AN OFFICE OF BUDGET, THAT OFFICE
CENTRALIZES A LOT OF NIH BUDGET
INFORMATION FROM ALL OF THE
ICs, COORDINATING RESPONSES TO
DATA CALLS AND THINGS LIKE THAT.
AND THAT OFFICE SERVES AS THE
MAIN CONTACT WITH THE DEPARTMENT
OF HEALTH AND HUMAN SERVICES,
THE OFFICE OF MANAGEMENT AND
BUDGET, AND CONGRESSIONAL
APPROPRIATION STAFF.
AND THEN, WITHIN EACH INSTITUTE
AND CENTER, THERE IS A BUDGET
OFFICE FOR THAT IC.
IN NICHD THIS IS CALLED THE
FINANCIAL MANAGEMENT BRANCH SO I
AM THE BUJ THE OFFICER AND THE
BRANCH CHIEF AND SMB PROVIDES
ADVICE AND GUIDANCE TO THE
LEADERSHIP AND STAFF OF THE
INSTITUTE.
WE HELP DEVELOP SPENDING PLANS
TO SUPPORT THE IC PRIORITIES AND
WE HELP GIVE INFORMATION TO HELP
GUIDE PLANNING DECISIONS FOR
FUTURE YEARS AND THEN WE MONITOR
OUR SPENDING TO MAKE SURE WE'RE
ADHERING TO THE OPERATING PLAN
AND THE FEDERAL RULES FOR
SPENDING FUNDS.
AND WE INTERACT WITH STAFF
ACROSS THE IC, INTRAMURAL AND
EXTRAMURAL, ADMINISTRATIVE
BECAUSE WE NEED TO KNOW WHAT'S
HAPPENING.
BUDGET AFFECTS AND IS AFFECTED
BY EVERYTHING THAT THE IC DOES.
NEXT SLIDE, PLEASE.
SO WHEN AN IC RECEIVES A FULL
YEAR BUDGET OR CR, WE HAVE TO
SUBMIT AN OPERATING PLAN TO THE
NIH OFFICE OF BUDGET.
THIS OPERATING PLAN IS THEN ALSO
REPORTED TO OMB AND TO CONGRESS.
IT'S BASED ON THE PROGRAMMATIC
NEEDS OF THE IC, AND THEN AT THE
END OF THE FISCAL YEAR, WE
RECONCILE HOW WE ACTUALLY SPENT
THE MONEY COMPARED TO HOW WE
SAID WE WOULD SPEND THE MONEY IN
THE PLAN.
WE DISPLAY THIS OPERATING PLAN
IN SOME DETAIL IN THE FORM OF A
MECHANISM TABLE.
SO A MECHANISM TABLE ACCOUNTS
FOR THE WAYS THE ICs WILL USE
THE BUDGET WHETHER IT'S IN
GRANTS, CONTRACTS, INTRAMURAL
RESEARCH OR ADMINISTRATIVE
SPENDING.
THE INITIAL MECHANISM TABLE FOR
A YEAR IS PART OF THE
PRESIDENT'S BUDGET AND THEN WE
REVISE IT TO REFLECT ACTUAL
APPROPRIATIONS OR WHEN OUR PLANS
CHANGE BECAUSE WHEN YOU BUILD A
BUDGET OVER A YEAR IN ADVANCE,
SOMETIMES REALITY MAKES THINGS
CHANGE.
THE MECHANISM TABLE CAN BE
UPDATED EACH QUARTER AND THEN
AGAIN AS I SAID, USE IT AT THE
END OF THE YEAR TO REFLECT OUR
ACTUAL SPENDING.
BECAUSE ALL OF THE ICs AT NIH
VARY IN THE KINDS OF SCIENCE
THEY SUPPORT AND THE DIFFERENT
KINDS OF GRANT ACTIVITY CODES
THEY USE, ET CETERA, THESE
TABLES ALLOW US TO COMPARE THE
BUDGETS ACROSS THE SAME
CATEGORIES FOR ALL OF NIH.
NEXT SLIDE, PLEASE.
SO THIS IS AN EXAMPLE OF A
MECHANISM TABLE.
I HAVE ELIMINATED THE ROWS WHERE
NICHD HAS ALL 0S, THERE ARE
ADDITIONAL CATEGORIES IN THE
INTEREST OF TRYING TO MAKE IT
SLIGHTLY EASIER TO READ, I
ELIMINATED THE 1S WHERE WE DON'T
HAVE ANY SPENDING.
CAN YOU SEE ON THIS CHART THAT
WE HAVE OUR FYTWEBT 20 ACTUALS
AND OUR FY21 ACTUALS AND WE SHOW
THE MEMBER OF GRANTS AND THE
DOLLARS IN THOUSANDS ASSOCIATE
TD WITH THEM.
WE HAVE A BLOCK AT THE TOP FOR
RPGs WHICH ARE BROKEN OUT INTO
A BIT MORE DETAIL IN TERMS OF
NONCOMPETING ADMINISTRATIVE
SUPPLEMENTS AND COMPETING
GRANTS.
WE HAVE INFORMATION ON OUR SBIR
AND STTR GRANTS WHICH I WILL
TALK ABOUT MORE IN A SECOND.
WE ALSO HAVE RESEARCH CENTERS
WHICH CAN HAVE DIFFERENT TYPES
OF CENTER GRANTS.
WE HAVE A CATEGORY THAT IS
CALLED OTHER RESEARCH WHICH IS
LIKE Ks, CLINICAL RESEARCH AND
A LOVELY CATCH-ALL, ALL OTHER.
WE ALSO HAVE OUR RESEARCH
TRAINING GRANTS WHICH ARE REALLY
OUR MRSA TRAINING GRANTS SO THE
INDIVIDUAL AWARDS ARE WHAT FOLKS
MIGHT KNOW AS F-AWARDS AND
INSTITUTIONAL WARKSDS LIKE THE
T32S.
WE ALSO SHOW HERE WHAT WE SPEND
ON RESEARCH AND DEVELOPMENT
CONTRACTS EVERY YEAR.
WHAT WE SPEND ON INTRAMURAL
RESEARCH PROGRAM AND THEN WHAT
WE SPEND ON WHAT WE CALL RMS OR
RESEARCH MANAGEMENT AND SUPPORT.
AND THAT REALLY IS THE FUNDS
THAT GO TO PAY THE SALARIES FOR
ADMINISTRATIVE STAFF AND
EXTRAMURAL STAFF SUPPORTING THE
EXTRAMURAL PROGRAMS.
NEXT SLIDE, PLEASE.
AND THEN THIS CHART JUST TAKES
THAT MECHANISM TABLE, MAKE ITS
MAYBE A LITTLE BIT MORE
GRAPHICALLY FUN, BUT IT DOES
SMOA YOU THAT RPGs ARE MORE
THAN HALF OF WHAT OUR IC SPENDS
OUR MONEY ON.
YOU KNOW WE SPEND A SIGNIFICANT
AMOUNT OF SHARE ON CONTRACTS AND
INTRAMURAL RESEARCH AS WELL,
BUT, YOU KNOW RPGs ARE
DEFINITELY WHAT WE SPEND THE
MOST AMOUNT OF MONEY ON.
NEXT SLIDE, PLEASE.
WHEN WE'RE LOOKING AT OUR
BUDGET, THERE ARE OTHER THINGS
WE NEED TO CONSIDER.
WE DO HAVE MANDATED PROGRAMS
WHERE WE'RE REQUIRED TO SPEND A
CERTAIN AMOUNT OF MONEY.
THE BIGGEST 1 WE HAVE IS OUR
AIDS BUDGET.
IN FY21 WE SPENT $147.7 MILLION
ON AIDS.
THE OFFICE OFA AIDS RESEARCH AT
NIH COORDINATES THE AIDS
RESEARCH AND BUDGET ACROSS NIH
AND TELLS US HOW MUCH OF OUR
MONEY IS GOING TO BE SPENT ON
AIDS EACH YEAR.
WE MUST SPEND THIS MONOAIDS
PROJECTS.
THE OTHER MANDATED PROGRAM IS
OUR SMALL INNOVATION RESEARCH
AND BUSINESS TECHNOLOGY TRANSFER
PROGRAMS, SBIR AND STTR.
IN 2021 THAT WAS $46.7 MILLION.
IT IS A LEGISLATIVE MANDATE THAT
A PERCENTAGE OF OUR EXTRAMURAL
FUNDING BE SPENT IN EACH OF
THESE CATEGORIES.
IT'S ABOUT .45% FOR STTR, AND
3.2% FOR SBIR.
WE CANNOT MOVE MONEY BETWEEN
THOSE 2 CATEGORIES.
SO WE MUST BE VERY MINDFUL OF
HOW MUCH WE'RE SPENDING IN EACH
AREA.
EVERY YEAR WHEN WE'RE WORKING ON
OUR BUDGET, WE HAVE TO CONSIDER
OUR NONGRANT MECHANISMS,
OBVIOUSLY.
IN PERSONNEL WE HAVE PAY RAISES
WHICH ARE MANDATED FROM THE
WHITE HOUSE.
WE HAVE TO DECIDE ON WHAT HIRING
WE INTEND TO DO.
THE PRINCIPAL INVESTIGATOR
RECRUITMENT, THINGS LIKE THAT
THAT DR. BIANCHI TALKS ABOUT IN
HER PRESENTATION, WE ALSO TALK
ABOUT INCREASES IN NIH
ASSESSMENTS.
SO THESE ARE AREAS WHERE NIH
PROVIDE SERVICES FOR ALL ICs,
AND THINGS LIKE CYBERSECURITY,
RENT, OR THE CLINICAL CENTER.
WE ALSO HAVE TO PLAN FOR
RENOVATION COSTS IF WE ARE
UPGRADING LABS OR UPGRADING
OFFICE SPACE AND THEN WE ALSO
NEED TO FIGURE OUT HOW TO PAY
FOR SERVICES THAT THE IC ON
PROVIDES TO ALL THE STAFF SUCH
AS IT SUPPORT OR COMMUNICATIONS.
AND THEN EVERY YEAR THERE ARE
ALWAYS THINGS THAT WE DO
NOT--ADDITIONAL THINGS WE DO NOT
CONTROL.
THE FIRST 1 IS A LEGISLATIVE
THING WHICH IS CALLED A
RESCISSION.
THAT IS WHEN CONGRESS THROUGH
LEGISLATION REDUCES OUR
APPROPRIATION.
AND WE JUST HAVE TO FIGURE OUT
HOW TO ACCOMMODATE THOSE
REDUCTION SAYS.
THEY USUALLY ONLY HAPPEN ONCE A
YEAR SO WE KNOW PRETTY EARLY IN
THE YEAR, USUALLY, BUT IT IS
SOMETHING WE HAVE TO DEAL WITH.
>> WE ALSO HAVE ADDITIONAL TAX
AND ASSESSMENTS FOR THE
DEPARTMENT, FOR THE NIH OD THAT
WE MAY HAVE TO DEAL WITH,
THERE'S OFTEN UNEXPECTED NEEDS
AND EMERGENCIES, THINGS LIKE
ZIKA OR COVID FOR EXAMPLE.
WE HAVE TO ACCOMMODATE NIH
POLICIES SUCH AS INCREASES FOR
STIPENDS ON TRAINING GRANTS OR
FOR FELLOWS AND THEN WE DEAL
WITH NEW LEGISLATIVE OR POLICY
MANDATES SUCH AS OUR IMPROVE
INCREASE THIS YEAR.
AND THEN WE'RE ALSO TRYING TO
LACK AT WHETHER THERE'S ANY WAYS
WE CAN SAVE MONEY TO BE MORE
FLEXIBLE AND FREE UP FUNDS.
NEXT SLIDE, PLEASE.
SO HERE, I JUST WANTED TO SHOW
YOU FOR OUR INTRAMURAL AND OUR
RMS PROGRAMS HOW THE FUNDING
BREAKS DOWN.
WE REALLY DO SPEND THE MONEY IN
THOSE PROGRAMS IN THE SAME 3
CATEGORIES, SALARIES, AND
ASSESSMENTS AND THEN OTHER.
BUT THE PROPORTIONS ARE VERY
DIFFERENT.
INTRAMURAL RESEARCH ON THIS
CHART DOES INCLUDE OUR DIFFERENT
OPERATING COSTS, THE ASSESSMENTS
INCLUDE THINGS LIKE RENT, THE
CLINICAL CENTER WHICH IS ONLY AN
INTRAMURAL COST, PAYING FOR NIH
OD THINGS SUCH AS THE CENTRAL
CSR, THE REVIEW FOR GRANTS AND
THEN CIT, INFORMATION TECHNOLOGY
AND THEN THE HHS, AND PROGRAM
SUPPORT CENTER COSTS, PROGRAM
SUPPORT CENTER IS THE PLACE THAT
PROCESSES OUR PAY ROLL AND ALSO
A LOT OF OUR GRANTS PAYMENTS.
THE OTHER CATEGORY INCLUDES
THINGS LIKE SUPPLIES, EQUIPMENT,
TRAVEL, TRAINING, PRINTING AND
OTHER MISCELLANEOUS CONTRACTS
INCLUDING OUR LAB SUPPORT.
NEXT SLIDE, PLEASE.
SO NOW WE WILL TALK A LITTLE BIT
ABOUT GRANTS BUDGET WHICH IS I
KNOW FOLKS ARE ALWAYS INTERESTED
IN.
NEXT SLIDE.
SO YOU'RE GOING TO HAVE A
PRESENTATION IN A LITTLE BIT
ABOUT HOW WE DO INITIATIVES BUT
WE ALL ARE INVOLVED CERTAINLY IN
THAT PROCESS AND A LOT OF THESE
FACTORS ARE IMPORTANT THERE.
WE TRY TO PROJECT THE GRANT COST
FOR A YEAR SO THAT WE CAN PLAN
WELL FOR NEW STARTS AND NEW
FOAs, SO, WE'RE LOOKING AT
EXISTING COMMITMENTS FOR OUT
YEARS, CO FUNDING COMMITMENTS,
WE'VE MADE TO OTHER ICs, WE
WANT TO MAKE SURE WE'RE
SUPPORTING EARLY STAGE
INVESTIGATORS.
AND THEN MAKE SURE WE SET ASIDE
FUNDS AND ANY BRIDGE FUND
THAGOREAN IS NEEDED FOR GRANTS
FOR COMPETITIONS WHICH MAY HAVE
BEEN DELAYED, WE WANT TO SET
ASIDE RFAs THAT WE COMMITTED
TO AND THEN WE ALSO HAVE AT OUR
INSTITUTE IN PARTICULAR SOME
FUNDING COMMITMENTS THAT WE MADE
SO NCMRR WE MADE A COMMITMENT
THAT THAT CENTER AND WE'VE ALSO
COMMIT THAD WE WILL SUPPORT OUR
TRAINING MECHANISMS, OUR T, F,
AND K GRANTS WITH AT LEAST 6% OF
EXTRAMURAL FUNDING EVERY YEAR AS
WELL.
NEXT SLIDE, PLEASE.
SO WHEN WE'RE LOOKING AT
DEVELOPING OUR RPG ALLOCATIONS,
THERE'S A LOT OF IT THAT GOES
INTO IT, A LOT OF MOVING PIECES,
OUR NICHD LEADERSHIP PROVIDES
GUIDANCE TO US ON A LOT OF THESE
QUESTIONS HERE.
YOU KNOW HOW MUCH ARE WE GOING
TO SPEND ON SUPPLEMENTS IN A
GIVEN YEAR, ADMINISTRATIVE AND
DIVERSITY SUPPLEMENTS.
WHAT REDUCTIONS MIGHT WE TAKE ON
NONCOMPETING GRANTS?
MAKE SURE WE COMPLETED
COLLABORATIONS INCOMING AND
OUTGOING AND THEN WE HAVE SPL
SET ASIDES AND DIRECTORS
RESERVES WHERE WE HOLD FUNDS TO
ADDRESS SPECIAL TOPICS OR TO
WAIT TO MAKE SURE WE'VE COVERED
ANY EMERGENCIES.
THIS YEAR, SET ASIDES INCLUDE
THOSE IMPROVED SET ASIDES FOR
EXAMPLE AND, WE'VE ALSO SET
ASIDE SOME FUNDS FOR COVID IN
THE LAST SEVERAL YEARS.
NEXT BULLET.
THERE WE GO.
WE'RE ALSO LOOKING AT ESTIMATING
LEVELS OF UNOBLIGATED BALANCE IN
EXISTING NONCOMPETING GRANTS.
SO IF A CLINICAL TRIAL GRANT IS
HAVING A LOT OF ISSUES WITH
ENROLLMENT WHICH DURING COVID
WAS A COMMON PROBLEM.
YOU KNOW WE WORK WITH GRANTEES
TO TRY TO MAYBE PROVIDE THEM
MORE TIME WITHOUT PROVIDING
ADDITIONAL YEAR OF FUNDING AND
THAT GIVES US SAVINGS IN THE
CURRENT BUDGET YEAR.
NEXT BULLET PLEASE.
WE'RE ALSO SETTING ASIDE FUNDS
FOR TAPs, WE HAVE LEGISLATIVE
MANDATED TAX FOR THE
APPROPRIATE--WHAT WE CALL
PROGRAM AND EVALUATION TAPS AND
FOR TRAINING TAPS AND THEN LAST
BULLET.
AND THEN WE'RE SETTING ASIDE
FUNDS FOR CONGRESSALLY MANDATED
PROGRAMS AND THE NATIONAL
ACADEMY STUDIES, THE MIS-C, THIS
YEAR WE SET ASIDE SOME FUNDS FOR
LIFE EVENT SUPPLEMENTS FOR SOME
EARLY STAGE INVESTIGATORS.
SO ALL OF THOSE THINGS ARE GOING
INTO OUR DECISIONS ABOUT HOW
MUCH MONEY WE HAVE FOR NEW
RPGs, NEXT SLIDE, PLEASE.
ONCE WE'VE TAKEN ALL THOSE
PIECES INTO ACCOUNT, WE ARE
LOOKING THEN, OKAY, WE HAVE A
POOL OF AVAILABLE FUNDS AND HOW
DO WE TETERM HOW MANY GRANTS
THAT CAN PAY.
SO WE LOOK AT HISTORICAL FUNDING
OF INVESTIGATOR INITIATED GRANTS
OVER THE PAST SEVERAL YEARS BY
COUNCIL ROUND AND WE LOOKAD A
3-YEAR AVERAGE IN GENERAL TO
DETERMINE THE PERCENTAGE THAT IS
SPENT ON EACH COUNCIL ROUND.
AND WE TAKE THIS YEAR'S
AVAILABLE FUNDS AND WE DIVIDE IT
OUT USING THAT HISTORICAL
SPENDING PATTERN.
DEPENDING WHERE WE ARE IN THE
FISCAL YEAR.
WE WILL LOOK AT THE APPLICATIONS
THAT HAVE ALREADY BEEN SCORED TO
TRY TO ASSESS THE COST AND
FIGURE OUT WHAT KINDS OF
ALLOCATIONS WE CAN PROVIDE TO
OUR EXTRAMURAL BRANCHES SO THAT
THE FUNDING CAN BE RELATIVELY
CONSISTENT ACROSS COUNCIL
ROUNDS.
MY GOAL AS BUDGET OFFICER IS
THAT WHEN A GRANTEE APPLIES TO
NIH, IT SHOULD NOT REALLY MATTER
WHETHER THEY--WHAT COUNCIL ROUND
THEY APPLY TO, OCTOBER OR JUNE
FOR EXAMPLE THAT IF THEY GOT THE
SAME SCORE, THEY SHOULD HAVE THE
SAME SORT OF LIKELIHOOD OF BEING
FUNDED ABSENT, YOU KNOW
CONSIDERATION FOR SCIENTIFIC
PRIORITY WHICH IS ALWAYS THE
MOST IMPORTANT THING.
TRADITIONALLY AS YOU SEE ON THIS
CHART, JUNE COUNCIL IS OUR
LARGEST COUNCIL.
HOWEVER IN THE PAST COUPLE YEARS
WE'VE STARTED TO SEE A LITTLE
BIT OF A SHIFT AND OCTOBER
COUNCIL SEEMS TO BE GROWING.
NEXT SLIDE, PLEASE.
FOR MECHANISMS OTHER THAN
RPGs, THERE ARE A FEW
DIFFERENT CONSIDERATIONS WE HAVE
TO TAKE THE YOU CAN BE THE
ALWAYS REDUCE APPLICATIONS FOR A
GRANT.
SO FOR THINGS LIKE K12S OR T32S
WE CAN TAKE WHAT WE CALL OFFSETS
IF A GRANTEE HAS HISTORICALLY
NOT BEEN FILLING APPROVED SLOTS
ON THOSE GRANTS, THEY CAN BUILD
UP SIGNIFICANT BALANCES AND WE
CAN USE THAT TO GET SAVINGS IN
THE CURRENT BUDGET YEAR.
WE DO FOR TRAINING MECHANISMS
TAKE IN RECOMMENDATIONS OF THE
NICHD TRAINING COMMITTEE.
WE HAVE TO DEAL WITH NIH WIDE
STIPEND INCREASES, THIS YEAR WE
HAD A FLEW CHILDCARE ASSISTANCE
PAYMENT THAT OUR T32 AND
F-GRANTEE GRANTEES ARE ELIGIBLE
FOR.
IF WE HAVE AN ACTIVITY CODE
GRANT MECHANISM THAT WE VERY
RARELY FUND, WE WILL ASK FOR
PROGRAM INPUT ON WHAT WE SHOULD
DO WITH THAT BUT ULTIMATELY IT
REALLY DOES COME DOWN TO
AVAILABILITY OF FUNDS AND HOW
MUCH CAN WE SUPPORT IN A GIVEN
AREA.
AND THAT I BELIEVE IS MY LAST
SLIDE.
I'M HAPPY TO TAKE QUESTIONS.
I DIDN'T GO TOO FAR OVER, I
THROUGH A LOT OF INFORMATION AT
YOU BUT IF YOU HAVE QUESTIONS
I'M HAPPY TO TRY TO ANSWER.
>> THANK YOU.
ALEXIS, I SEE ALREADY, THAT ALAN
HAS A QUESTION.
CAN WE TAKE THE SLIDES DOWN?
I JUST WANT EVERYONE TO REALIZE
HOW MUCH WORK IS INVOLVED AND I
DON'T THINK YOU APPRECIATE HOW
ALEXIS AND HER TEAM NEED TO
CONTINUOUSLY MODEL THE BUDGET.
THAT WE HAVE MULTIPLE MECHANISM
TABLES BASED ON PRESIDENT'S
BUDGET, WHAT WE THINK MIGHT
HAPPEN, WHAT ADDITIONAL
INFORMATION OCCURS AND THEN
ALEXIS AND TEAM KIND OF CHANGE
IT AGAIN AND THEN WE GET AN
ACTUAL APPROPRIATION, ALL OF
THAT REQUIRES MODELING
CONTINUOUSLY IN REALTIME.
SO WE'RE VERY APPRECIATIVE OF
THEIR EXPERTISE.
SO WHY DON'T WE START WITH ALAN.
>> THANK YOU.
>> YEAH, REALLY THANK YOU FOR A
VERY INFORMATIVE SESSION.
I HAVE DEALT WITH SOME GRANTS
WHERE WE LOOK AT COMPUTATION, WE
CAN ONLY START TO IMAGINE THE
SCALE OF, YOU KNOW THE WORK THAT
YOU DO SO I COULD ALSO SAY THAT
YOU ARE ABLE, I GUESS BETWEEN
2020 AND 2021 TO GET AN INCREASE
IN NEW COMPETING GRANTS, A BIT
OF AN INCREASE WHICH IS
TERRIFIC.
UNDER ALL THAT REAL REALLY GREAT
THINGS BUT I WANTED TO GO TO
JUST BRING UP SOMETHING THAT'S
BEEN VERY NEAR AND DEAR TO MY
HEART IS NETWORKS AND I COULD
SEE 5% FOR [INDISCERNIBLE] AND
1% FOR U-GRANTS.
WHERE DO NETWORKS, NICHD
NETWORKS FIT IN AND--
>> SO I WILL SAY NETWORKS ARE
COMPLICATED TO BREAK OUT AND
PART OF THAT IS A FEATURE OF THE
MECHANISM TABLE.
SO THE MECHANISM TABLE, THOSE
LINES THAT YOU SAW, THOSE
CATEGORIES, NIH CENTRALLY TELLS
US WHICH GRANT ACTIVITY CODES GO
IN WHICH LINE.
SO EVEN THOUGH IT SAYS CENTERS
FOR EXAMPLE, THAT IS LIMITED TO
SPECIFIC ACTIVITY CODE.
SO IT IS THINGS LIKE P50S, P20S,
P30S, U54s.
THERE ARE NETWORKS AND CENTERS
THAT USE THINGS LIKE U19S, OR
UMs WHICH IS 1 OF THE NEW 1S
AND THOSE THINGS ARE IN THE RPG
LINE AND SO, THEY DON'T
NECESSARILY GET REFLECTED IN
CENTERS OR NETWORKS.
SOME OF OUR DCCs FOR EXAMPLE,
ARE U24 GRANTS.
U24S ARE NOT IN THE COOPERATIVE
CLINICAL LINE.
THEY'RE IN THE OTHER CATEGORIES.
AND SO FOR NETWORKS WHEN WE'RE
TRYING TO GET A PATIENTS IN THE
CLINIC UPPER OF THAT, WE
ACTUALLY HAVE TO DO SORT OF AN
INDEPENDENT CALCULATION TO PULL
ALL OF THOSE FROM THE DIFFERENT
CATEGORIES TO TRY TO ADD THEM
TOGETHER.
IT'S NOT SOMETHING THAT YOU CAN
EASILY FIND FROM A MECHANISM
TABLE UNFORTUNATELY.
>> SO--NO, NO, THANK YOU.
AND JUST--IF I COULD PUSH
FORWARD JUST TO SAY, IN GENERAL
THEN WHAT IS THE [INDISCERNIBLE]
OF THIS BUDGET, WHAT IS THE
ESTIMATED BUDGET FOR NETWORKS
USING YOUR BEST ESTIMATE AND
WHAT HAS BEEN THE TRENDS BETWEEN
2020 AND 2021 AS THINGS HAVE I
GUESS BEEN AFFECTED BY COVID AND
OTHER PLANTS.
>> YEAH, I HATE TO GUESS WRONG.
I BELIEVE WE HAD A DECLINE IN
OUR SUPPORT FROM 2020-2021,
EXCEPT FOR MAYBE SPECIFIC CASES
WHERE WE'VE HAD REALLY LARGE
BALANCES IN NETWORKS AND WE DO
WHAT I WAS TALKING ABOUT WHERE
WE GIVE AN EXTRA YEAR OF TIME.
SO SOMETIMES YOU WILL SEE A 1
YEAR DIP IF WE WEREN'T ABLE TO
HAVE GOOD ENROLLMENT.
WE WILL EXTEND TIENL ON THE
ENROLLMENT AND GIVE THEM TIME ON
THE END FOR MONEY.
SO YOU SOMETIMES HAVE SMALL DIPS
YEAR TO YEAR BUT IN GENERAL THE
FUNDING HAS BEEN FAIRLY
CONSISTENT.
>> YOU DON'T HAVE TO BE PUT ON
THE SPOT.
DO YOU WANT TO CHECK THE DATA
AND GET BACK TO US TOMORROW.
>> WE CAN GET YOU A NUMBER, A
GOT ESTIMATE FOR NETWORKS BUT I
WOULD HATE TO GUESS WRONG AND
HAVE IT BE RECORDED FOR
POSTERITY FOR EVERYONE.
>> WE BELIEVE IN FACTS.
[LAUGHTER]
>> WE CAN GET THE FACTS
TOMORROW.
>> DR. BARKIN.
>> THANK YOU ALEXIS, WHAT AN
EXTRAORDINARILY COMPLICATED JOB
YOU HAVE.
WE ARE SO APPRECIATIVE FOR YOUR
LEADERSHIP AND YOUR WORK.
CAN YOU TALK ABOUT HOW DOES ALL
OF THIS FIT TOGETHER TO CREATE A
FORMULA TO DETERMINE WHAT THE
PAY LINES ARE AND IF YOU'RE
ALLOWED TO SHARE SORT OF THE
RANGE OF CURRENT PAY LINES.
SO, I WILL SAY WE DO HAVE SOME
IN THE LAST--IN THE TIME I'VE
BEEN HERE, WE HAVE REALLY
CHANGED IN A LOT OF WAYS AND
GOTTEN AWAY FROM SOME OF THE
HARD, WHAT WE CALL HARD PAY
LINES, MEANING THAT YOU KNOW IN
THE PAST, WE WERE SORT OF
CONSTRAINED IN TERMS OF TRYING
TO REACH FOR THE REALLY
INNOVATIVE SCIENCE, LET'S SAY
THAT WAS JUST BEYOND THE PAY
LINE AND SO, WE'VE CHANGED A LOT
OF WAYS WE DO THAT.
WE HAVE MECHANISMS WHICH STILL
HAVE DEFINED PAY LINES, OUR
K-AWARTS FOR EXAMPLE, THE
INDIVIDUAL Ks DO STILL HAVE A
DEFINED PAY LINE AND IN THAT
WAY, WHAT WE USUALLY DO IS, WE
SET ASIDE THE BEGINNING OF THE
YEAR, WE SAY FOR EXAMPLE, WE'RE
GOING TO HAVE $8 MILLION FOR NEW
INDIVIDUAL K-AWARDS.
AND THEN WE DO THAT CALCULATION
WITH THE PERCENTAGES BY COUNCIL
ROUND AND SORT OF FIGURE OUT,
OKAY, IF THAT'S WHAT WE HAVE,
HOW DOES THAT BREAK OUT BY
COUNCIL ROUND AND THEN WE LOOK
AT THE SCORES WE HAVE AND WE
SAY, WELL, FOR 2 AND HALF
MILLION DOLLARS IN OCTOBER, WE
CAN GET DOWN TO A 24 FOR THE
REGULAR Ks AND A 30 FOR THE
K99S.
SO WE--WE'RE DOING THOSE SORTS
OF CALCULATIONS, AND THEN, WE
USUALLY KEEP REVISING THROUGH
THE YEAR, SO IF WE'RE GETTING TO
JUNE COUNCIL AND IT LOOKS LIKE
WE HAVE A SURPLUS OF OUR
$8 MILLION, WE WILL GO BACK AND
SAY, OKAY, LET ALET'S PICK UP
MORE Ks, CAN WE MOVE THE PAY
LINE DOWN TO 26.
SO WE ARE CONSTANTLY ADJUST
NOTHING THAT WAY.
FOR THE THINGS THAT DO NOT HAVE
HARD PAY LINES OR RPGs NOW DO
NOT HAVE A HARD PAY LINE, WE
HAVE WHAT WE CALL A ZONE OF
CONSIDERATION.
WE FIGURE OUT SORT OF AN
ALLOCATION WE CAN GIVE TO EVERY
EXTRAMURAL BRANCH TO HOPEFULLY
FUND FAIRLY EQUITABLY ACROSS THE
BRANCHES.
WE TRY TO GIVE EXTRA MONEY TO
FUND ESIs, EARLY STAGE
INVESTIGATORS, BECAUSE THAT'S AN
IMPORTANT NIH TARGET AS WELL.
AND THEN WE LET THE BRANCH
CHIEFS REALLY HAVE SOME
DISCRETION.
IF THEY WANT TO, THEY COULD FUND
EVERYTHING IN LINE BY SCORE OR
IF THEY WANT TO SORT OF, YOU
KNOW SKIP SOMETHING, REACH FOR
SOMETHING, YOU KNOW THEY HAVE
THAT FLEXIBILITY, AND SO FOR THE
RPGs RIGHT NOW, OTHER THAN I
BELIEVE THE R15s, WE DON'T
REALLY HAVE A SET PAY LINE.
FOR THOSE GRANTS AT THE MOMENT.
DOES THAT ANSWER YOUR QUESTION?
>> YES, THANK YOU.
OKAY, GOOD.
>> OKAY, WELL AALEXIS, THANK YOU
AGAIN FOR THAT FANTASTIC UPDATE,
EVERYONE LEARNED A LOT FROM IT,
INCLUDING ME, I ALWAYS LIKE TO
HEAR IT AGAIN, SO AND YOU'RE
GETTING A LOT OF POSITIVE KUDOS
IN THE CHAT SO WHEN YOU GET A
CHANCE, TAKE A LACK AT THE CHAT
BOX.
>> THANK YOU VERY MUCH AND
CERTAINLY IF YOU THINK OF
QUESTIONS AS WE'RE GOING ALONG
AND YOU WANT TO PUT THEM IN THE
CHAT, I WILL KEEP WATCHING THE
CHAT AND I WILL WORK ON
DR. JANE'S ESTIMATE FOR NETWORKS
AND TRY TO GET BACK TO YOU ON
THAT AS WELL.
>> DR. TIDA,.
>> SORRY, MY APOLOGIES.
>> SOUNDS GOOD, THANK YOU.
>> THANK YOU, BYE-BYE.
>> SO WE'RE KIND OF--THIS IS
MORE OR LESS A THEME OF, YOU
KNOW BASIC INTRODUCTORY
INFORMATION THAT REALLY
EVERYBODY SHOULD HAVE BUT
BECAUSE YOU'RE ON COUNCIL YOU
SHOULD ESPECIALLY HAVE
INFORMATION.
AND THIS NEXT PRESENTATION CAME
FROM A QUESTION THAT OCCURRED
DURING A PREVIOUS COUNCIL
MEETING AND THE PRESENTATION
WILL BE GIVEN BY DR. CAROLINE
SIGNORE, SHE'S THE DEPUTY
DIRECTOR OF EXTRAMURAL RESEARCH
FOR NICHD AND SHE WILL BE
TALKING ABOUT THE PROCESS WE USE
FOR PLANNING NEW INYAISHATIVES
SO WHEN YOU'RE ASKED TO VOTE ON
CONCEPT CLEARANCE OR TO VOTE ON
RECOMMENDATIONS FOR SET ASIDE
GRANTS, WE WILL TAKE YOU THROUGH
THAT WHOLE PROCESS.
SO THE GOAL IS TO CONNECT THE
DOTS FROM PROGRAM STAFF
PROPOSING INITIATIVES, TO
CONCEPT CLEARANCE TO
UNDERSTANDING HOW WE SET ASIDE
FUNDS FOR THESE PROJECTS AND HOW
THE SET ASIDE FUNDS AFFECT THE
PAY LINES FOR OTHER TYPES OF
GRANT APPLICATIONS MRI KAIGDZS
SO IT FITS IN VERY NICELY WITH
WHAT YOU JUST HEARD FROM ALEXIS
SO LET ME INTRODUCE DR. SIGNORE.
>> THANK YOU SOPHISTICATEDY MUCH
AND THANK YOU DR. BIANCHI.
LET'S--I WILL TAKE YOU THROUGH
THE PROCESS BY WHICH NICHD
IDENTIFIES AND PLANS NEW
INITIATIVES AND BY INITIATIVES
I'M REALLY TALKING ABOUT FUNDING
OPPORTUNITY ANNOUNCEMENTS IN
GENERAL.
THINK OF THIS PERHAPS AS THE
ROAD TO AN RFA.
>> AND IN THIS TALK, I WILL GIVE
A SNAPSHOT OF A TIMELINE BETWEEN
AN IDEA AND ACTUALLY MAKING AN
AWARD.
WE WILL FOCUS MOST OF OUR TIME
ON WHAT I CALL THE OPERATIONAL
PLANNING PROCESS OR OP PLANNING
AND AGAIN THIS IS THE WAY WE
MAKE DECISIONS ON WHAT FOAs WE
WOULD LIKE TO ISSUE AND THEN WE
WILL KK BACK TO THE TIMELINE AND
DESCRIBE THE STEPS THAT OCCUR
AFTER THE OP PLANNING PROCESS.
AND WE WILL DO THIS BY
CONSIDERING A CASE STUDY WHICH
IS BASED ON A TRUE STORY OF AN
FY21 INITIATIVE, WHERE WE ISSUED
AN RFA FOR RESEARCH PROJECT
GRANTS OR R01s.
>> CAROLINE.
>> YES.
>> THE SLIDES ARE NOT SHOWING.
>> HMM.
>> ARE YOU SHARING?
>> I WAS GOING TO SHARE AND LET
ME STOP SHARING.
SO THAT OUR EXPERTS CAN SHARE.
>> IT ACTUALLY WAS SHOWING THAT
YOU WEREN'T--THERE WE GO.
>> OKAY, SORRY ABOUT THAT.
WE ARE GOING TO SORT OF
DEMONSTRATE THIS PROCESS BY
REVIEWING A CASE STUDY OR
HISTORY OF AN ACTUAL FY21
INITIATIVE WHICH WAS ISSUING AN
RFA FOR RESEARCH PROJECT GRANTS
OR RO-1S THAT WE INTENDED TO BE
AWARDED IN FY21.
SO HERE IS AN IMAGE OF A
TIMELINE THAT IS BASED ON A
PARTICULAR RFA AND HOW IT WAS
GENERATED AND I WANT TO POINT
OUT JUST A FEW FEATURES OF THIS
TIMELINE HERE AT THE BEGINNING.
ONE IS YOU'RE SEEING ALREADY
2018 THROUGH 2021, THAT IS A
LENGTHY PROCESS AND THIS IS
ACTUALLY FAIRLY TYPICAL FOR
COMING UP WITH AN RFA.
IN THIS PARTICULAR EXAMPLE, THE
IDEA STARTED IN RESPONSE TO A
WORKSHOP THAT WAS CONDUCTED BY
NICHD IN 2018.
SUBSEQUENTLY AWARDS WERE MADE IN
2021.
SO THAT'S 1 PIECE OF THIS, I
WOULD LIKE TO POINT OUT.
ANOTHER PIECE IS THAT IDEAS ARE
PITCHED AT THIS OP PLANNING
PROCESS AND YOU CAN SEE HERE
THAT THAT PROCESS OCCURS 2 YEARS
PRIOR TO THE ANTICIPATED FISCAL
YEAR OF FUNDING.
AND WE DO THAT BECAUSE THERE ARE
MANY, MANY STEPS BETWEEN A
DECISION TO ISSUE AN RFA AND THE
ACTUAL ISSUING OF IT AND MAKING
AWARDS.
AND THEN ANOTHER THING I WOULD
LIKE TO POINT OUT IS THAT
COUNCIL IS DIRECTLY INVOLVED AT
2 SEPARATE TIMES DURING THIS
PROCESS.
THE FIRST IS WHEN COUNCIL
ENTERTAINS CONCEPT PROPOSALS
FROM STAFF AS YOU'RE FAMILIAR
WITH.
IN OUR PARTICULAR CASE EXAMPLE,
THAT HAPPENED IN JANUARY OF
2020.
THE SECOND TIME IS LATER IN THE
PROCESS WHEN COUNCIL CONDUCTS
SECOND LEVEL REVIEW AND CONTENDS
OR CONSIDERS STAFF
RECOMMENDATIONS FOR FUNDING OF
APPLICATIONS THAT CAME IN IN
RESPONSE TO THE RFA.
BUT LET'S TALK NOW ABOUT THE
BEGINNING OF THIS PROCESS.
ALL INITIATIVES BEGIN WITH IDEAS
AND IDEAS ORIGINATE WITH PROGRAM
OFFICIALS.
WHO ARE REALLY ALWAYS ENGAGED IN
LOOKING FOR OPPORTUNITIES, GAPS
IN THE LITERATURE, GAPS IN
SCIENCE THAT NICHD, COULD
SUPPORT AND COULD ADDRESS.
SO THEY'RE SETTING UP WORKSHOPS
OR CONVERSE BEING WITH
SCIENTISTS WITHIN NICHK, ACROSS
NIH, OTHER AGENCIES AT MEETINGS,
CONDUCTING PORTFOLIO ANALYSIS,
TO IDENTIFY GAPS OR JUST KEEPING
UP WITH THE LITERATURE.
SO IN ALL OF THESE CASES,
PROGRAM STAFF ARE JUST KEEPING
THEIR EAR TO THE GROUND AND
ALWAYS STAYING ALERT FOR NEW
OPPORTUNITIES.
IDEAS THEN ARE TAKEN THROUGH OUR
OPERATIONAL PLANNING PROCESS,
BASICALLY WHICH CONSISTS OF
MAKING A PITCH OR A PROPOSAL FOR
CONSIDERATION.
THE COMPONENTS OF SUCH A
PROPOSAL OR A PITCH ARE INCLUDED
FOR EVERY INITIATIVE IN A
WRITTEN DOCUMENT THAT'S PREPARED
BY PROGRAM STAFF TYPICALLY 5-7
PAGES LONG THAT COVERS CERTAIN
KEY PIECES OF INFORMATION.
IN SOME CASES THESE PROPOSALS
ARE AUGMENTED WITH AN ORAL
PRESENTATION, I'LL GET BACK TO
THAT MOMENTARILY.
SO WHAT'S INCLUDED IN THESE
WRITE UPS?
IT WILL BE LAYING OUT THE
SCIENTIFIC BACKGROUND, THE
SCIENTIFIC ISSUE IS THAT'S BEING
ADDRESSED AND SPECIFICALLY WHAT
GAP IN THAT SCIENCE IS THE
RESEARCH INTENDED TO ADDRESS.
WHAT IS THE PURPOSE, WHAT IS THE
GOAL OF THIS NEW PROGRAM IN
TERMS OF ADDRESSING THIS NEED.
SOME INITIATIVES ARE RECURRING
AND FOR THOSE THAT ARE, THE
PROPOSAL WILL COMMENT ON WHAT
THE PAST HISTORY OF THIS
INITIATIVE HAS BEEN WHAT HAS
BEEN THE OUTPUT, WHAT HAS BEEN
THE IMPACT.
IMPORTANTLY WHY DOES THIS FIELD
STILL NEED TO BE STIMULATED BY
US ISSUING ANOTHER FUNDING
OPPORTUNITY ANNOUNCEMENT.
SIMILARLY, WHY SHOULD IT BE
NICHD FOR EXAMPLE AS OPPOSED TO
ANOTHER IC THAT MAY ALSO HAVE AN
INTEREST IN THE SCIENCE.
WE'RE ALSO LOOKING FOR HOW OUR
ALLIANCE ALIGNS WITH THE BRANCH
PRIORITIES AND FOR INITIATIVES
THAT WILL HAVE SET ASIDES, WHAT
IS THE PROPOSED BUDGET.
THERE ARE SORT OF 2 DIFFERENT
DIRECTIONS, THAT PLANNING TAKES
AT THIS POINT.
DEPENDING ON WHETHER THERE'S A
SET ASIDE OR NOT.
SO FOR THOSE INITIATIVES LIKE
RFAs OR RFPs THAT WILL HAVE
SET ASIDES ISSUES THE
OUTPLANNING PROCESS IS LARGELY
CONDUCTED ON AN ANNUAL MEETING
AS I MENTIONED 2 YEARS IN
ADVANCE OF THE ANTICIPATED
FUNDING FISCHERIAL YEAR.
ALTHOUGH THERE CAN BE ADHOC
MEETINGS AS NECESSARY AT OTHER
TIMES.
AND AT THIS LARGE MEETING
TYPICALLY ABOUT 20-30 NEW AND
RECURRING INITIATIVES ARE
PRESENTED BY INDIVIDUAL PROGRAM
STAFF SO EVERYONE'S DONE A WRITE
UP AND THEN THERE ARE THESE ORAL
PRESENTATIONS.
THIS MEETING IS ATTENDED BY ALL
EXTRAMURAL STAFF AND LEADERSHIP
WHO ARE ENCOURAGED TO ASKY
REQUESTS, IDENTIFY PROBLEMS AND
AND PRESENT SOLUTIONS AND OTHER
NERGYS.
THE OTHEISHATIVES THAT WILL NOTE
A SET ASIDE WHICH ARE LESS
DIRECTLY INFLUENCING BUDGET
DECISIONS, SO IN THOSE CASES,
MEETINGS ARE HELD QUARTERLY SO 4
TIMES A YEAR AND NOT NECESSARILY
2 YEARS IN ADVANCE OF AN
ANTICIPATED FUNDING YEAR.
THROUGH THIS PROCESS, WE CAN
PROPOSE OUR OWN NONSET ASIDE
INITIATIVES LIKE NOTICES OF
SPECIAL INTEREST, WE ALSO
FREQUENTLY WILL SIGN ON TO OTHER
INSTITUTES NOTICES, THIS MEETING
AS I SAID OCCURS QUARTERLY, IT'S
ATTENDED BY SOME D. E. R. STAFF
AND STAFF FROM THE NICHD, OFFICE
OF THE DIRECTOR WHO ARE
EVALUATING THE WRITTEN
PROPOSALS, IN THIS CASE THERE
ARE ORAL PRESENTATIONS MADE BY
INDIVIDUAL STAFF.
FOLLOWING PROPOSALS AND REVIEW
DECISIONS NEED TO BE MADE SO
WHAT FACTORS ARE TAKEN INTO
CONSIDERATION WHEN LEADERSHIP
ARE MAKING DECISIONS AND 1 OF
THEM IS JUST THE CLARITY OF THE
GOALS AND OBJECTIVES AS
PRESENTED.
THERE'S A LIKELIHOOD THAT WHAT'S
BEEN PRESENTED WILL BE
MEANINGFULLY ADDRESSED BY THE
SCIENTIFIC GAP AND MOVE THE
FIELD FORWARD AND IMPORTANT HOW
IMPORTANT IS THAT GAP IN SCIENCE
THAT'S BEING ADDRESSED WITH THE
PROPOSAL.
WHAT IS THE EXTENT TO WHICH THE
PROPOSAL MEETS THE GOALS AND
ASPIRATIONS OF THE NICHD
STRATEGIC PLAN OR PROGRAM
PRIORITIES.
FOR SET ASIDE FOAs FOR THE
RECOMMENDED BUNLET AND
IMPORTANTLY AS ALEXIS POINTED
OUT WE NEED TO TRY AND
UNDERSTAND WHAT THE AVAILABLE
FOR FUNDS FOR NEW INITIATIVES,
WHAT SORT OF PROGRAMS WILL BE
AVAILABLE.
SO FOR THAT I WILL TAKE YOU
THROUGH THE PROCESS AND TEMON
STRAIGHT HOW THAT AM CANS ABOUT
AND I WILL PAUSE HERE FOR A
MOMENT AND THANK ALEXIS CLARK
AND NICOLE FROM OUR BUDGET
OFFICE WHO WERE REALLY
INSTRUMENTAL IN HELPING ME PUT
TOGETHER THIS PART OF THE
PRESENTATION.
SO YOU'VE HEARD FROM ALEXIS THE
APPROPRIATION, IT COULD BE A
CONTINUING RESOLUTION AND THAT
ALWAYS MAKES THE JOB A LITTLE
BIT MORE CHALLENGING BUT IN
GENERAL 2021 YOU SAW THAT THE
EXTRAMURAL PORTION OF OUR
ANNUALA APPROPRIATION IS ABOUT
80%.
FROM THE ANNUAL APPROPRIATION,
THE COSTS FOR THE INTRAMURAL
RESEARCH PROGRAM AND OPERATIONS
OR RMS THAT ALEXIS SPOKE ABOUT
ARE TAKEN OFF THE TOP.
AND THEN FROM THERE, WE NEED TO
IDENTIFY HOW MUCH WILL BE
AVAILABLE FOR EXTRAMURAL WARKSDS
IN ORDER TO DO THAT WE MUST
FIRST UNDERSTAND WHAT OUR
OPERATING GLOBALLY LIGATIONS
FROM THE NONCOMPETING AWARDS, SO
YOU KNOW IF YOU THINK ABOUT A
TYPICAL R01.
THAT'S 5 YEARS LONG WE HAVE A
COMMITMENT OF BUDGET FUNDS TO
SUPPORT THE OUT YEARINGS WE CALL
THEM OF EVERY AWARDED GRANT.
SO WE KNOW WHAT THOSE COSTS WILL
BE 2 YEARS IN ADVANCE AND WE
DON'T KNOW WHERE ALL OF THEM AND
THIS IS WHERE THE ART OF
BUDGETING COMES IN WHERE
CONSERVATIVE ESTIMATES ARE MADE
BASED ON HISTORICAL DATA ABOUT
WHAT TOTALS MIGHT BE 2 YEARS
HENCE.
ONCE THOSE FUNDS ARE ACCOUNTED
FOR IF YOU WILL WHAT'S LEFT FOR
THE BANK IS WHAT'S AVAILABLE FOR
NEW EXTRAMURAL AWARDS.
ABOUT WE HAVE ALL NEW AWARDS AND
NOT JUST RFAs AND SO
INVESTIGATOR INITTIAIATED
GRANTS, SMALL BUSINESS AWARDS
TRAINING MANDATED PROGRAMS, LIKE
HIV/AIDS AND THE RECOMPETING
RFAs AND RFPs ONCE ALL OF
THOSE ARE ACCOUNTED FOR WHAT'S
LEFT ARE THE FUNDS AVAILABLE FOR
NEW INITIATIVES.
THIS WHOLE PROCESS IS
REPRESENTED GRAPHICALLY HERE AND
LET ME JUST SORT OF WALK YOU
THROUGH THIS.
EACH BAR HERE REPRESENTS AN
AMOUNT OF FUNDS.
THE TOP BAR IS THE TOTAL
APPRECIATION FOR FISCAL YEAR
2021 AND I'LL JUST GIVE YOU THE
BOTTOM LINE UP FRONT HERE
BECAUSE THE BOTTOM LINE IS THE
ACTUAL BOTTOM LINE, THIS LINE
HERE IS THE ENTIRE APPROPRIATION
THAT COULD BE PUT TOWARD NEW
INITIATIVES WITH SET ASIDES IN
THE FISCAL YEAR OF 2021.
AND SO THE WAY IN WHICH THAT IS
CALCULATED IS BY SORT OF
CEREALLY SUBTRACTING THE
COMPONENTS OF THE BUDGET IN
SEQUENTIAL FASHION.
SO HERE WE START WITH THE
APPROPRIATION.
WE SUBTRACT THE NEED FOR THE
INTRAMURAL PROGRAM, SUBTRACT THE
NEED FOR OPERATIONS OR RMS,
SUBTRACT THE NEEDS FOR RESEARCH
AND DEVELOPMENT CONTRACTS AND
AND STORT IN HERE WITH
NONCOMPETING.
I WANT TO POINT OUT A COUPLE
THINGS ABOUT THIS PARTICULAR
BAR.
ONE IS TO SEE JUST SICIALLY EVEN
HOW SUBSTANTIALLY NONCOMPETING
COMMITMENTS AFFECT OUR BUDGETS
AND OUR ALLOCATIONS.
BUT ALSO TO POINT OUT THAT THIS
IS THE BAR WHERE WE START
LOOKING AT HOW MUCH WE HAVE FOR
NEW AWARDS.
MOST OF THE AWARDS WE SUPPORT
ARE NEW INVESTIGATOR INITIATED
AWARDS SO HERE'S WHAT REMAINS
AFTER THOSE ARE ACCOUNTED FOR.
FINALLY, SUBTRACTING OUT
SBIRs, SUBTRACTING OUT
TRAINING, SUBTRACTING OUT AIDS,
SUBTRACTING OUT RECOMPETING
RFAs AND RFPs QUEE END UP
HERE WITH THE BOTTOM LINE, THIS
IS THE AMOUNT OF FUNDS THAT ARE
AVAILABLE FOR NEW RFAs AND
RFPs SO THAT'S THE NUMBER THAT
HELPS US MAKE DECISIONS ON WHAT
INITIATIVES WILL BE MOVING
FORWARD OUT OF OPERATIONAL OR
OP PLANNING.
HAVING CONCLUDED THAT THEN,
LET'S GO BACK TO OUR TIMELINE.
WE SAW THIS PROCESS IN OUR CASE
WITH THE WORKSHOP IN APRIL OF
2018.
WE ARE HERE HAVING JUST
DESCRIBED AND CONDUCTED OP
PLANNING FOR THAT INITIATIVE
CYCLE.
THAT TOOK PLACE IN THE SUMMER OF
2019.
AND FOLLOWING AN APPROVAL
THROUGH THE OP PLANNING PROCESS
IS THE FITTER TIME COUNCIL GETS
INVOLVED.
SO THAT ARE APPROVED FOR
PLANNING ARE BROUGHT TO COUNCIL
FOR OPINIONS AND APPROVAL BEFORE
PROCEEDING.
FOLLOWING COUNCIL APPROVAL OF A
CONCEPT, PART ABOUT WRITING THE
FUNDING OPPORTUNITY ANNOUNCEMENT
MPLET IN THIS CASE STUDY THAT
TOOK PLACE BETWEEN JANUARY AND
MARCH OF 2020 THAT'S A FAIRLY
EXPEDEIENT TIMELINE.
THERE ARE PORTS OF THIS PROCESS
THAT WE CAN'T CONTROL.
LARGELY THE FACT THAT AFTER IT
GOES TO FOA, IT GOES TO OFFICE
FOR REVIEW.
THERE REVIEW CAN BE LENGTH EXPE
TIME CONSUMING ESPECIALLY IF
THEY COME BACK TO AN IC WITH
SUGGESTIONS OR QUESTIONS FOR
EDITS OR CLARIFICATIONS.
ONCE EVERYTHING IS APPROVED IN
O. E. R., THE RFA IS PUBLISHED,
THINGS ARE ARE GETTING RUN OF
THE MILL NOW FOLLOWING
PUBLICATIONS, APPLICATIONS COME
IN, IN THIS CASE IN JULY OF
TWEBT 20.
APPLICATIONS THAT COME IN THIS
THE SUMMER ARE REVIEWED BY NIH
PEER REVIEW IN THE FALL.
HERE'S THE NEXT TIME COUNCIL
GETS INVOLVED.
STAFF MAKE RECOMMENDATIONS FOR
WHAT THEY SUGGEST COULD BE
FUNDED FROM THE FUNDING
INITIATIVE AND IN THIS CASE,
COUNCIL HEARD THESE
RECOMMENDATIONS IN THE
JANUARY 2021 COUNCIL.
YOU AND FOLLOWING THAT APPROVAL
THAT SUMS IT UP, FROM IDEA TO,A
WARD IN A NUT SHELL.
WE ARE ALWAYS LOOKING FOR WAYS
TO IMPROVE OUR PROCESSES, AND
ADAPT THEM SO YOUR COMMENTS AND
SUGGESTIONS ARE WELCOME AND I
WOULD ALSO BE HAPPY TO TRY AND
ENTERTAIN ANY QUESTIONS.
>> THANKS SO MUCH, I DID AN
INADVERTENT SWITCH ARADIO, AND I
SAW CAREEE LINE LIGHT UP AND IT
SEEMED LIKE HER TOPIC FLOWED
NICELY FROM THE BUDGET BUT IN
FACT THE NEXT PRESENTATION
SHOULD HAVE GONE BUYER CAROLINE.
NO WORRIES, I JUST DON'T WANT
YOU TO THINK YOU HAVE A BREAK
YET SO WITH THAT CAVEAT WE WILL
GO TO DAVID'S FIRST QUESTION.
THANKS, ALL.
IT'S FASCINATING TO SEE THE
PROCESS AND THE DELIBERATIONS
THAT NICHD GOES THROUGH TO
PREPARE AN RFA, MY PREPARATION
IS THE BEGIN OF THE IDEAS AND TO
WHAT EXTENT TO WE ENCOURAGE
PATIENT/PUBLIC INVOLVEMENT IN
FEEDING THOSE REQUESTEDS BECAUSE
THAT CAN BE A POSITIVE PART OF
THAT RELATIONSHIP WE HAVE WITH
THE TAXPAYER AND ALSO THE PEOPLE
WE CARE FOR, IS THERE A WAY FOR
THEM TO HAVE THEIR INPUT AT THE
BEGINNING AND HELP US THINK
ABOUT WHAT THE BIG CHALLENGES
ARE?
>> IT'S A GREAT QUESTION, THANK
YOU.
YOU KNOW NICHD IS GREATLY
ENGAGED WITH OUR ADVOCATES AND
GROUPS AND WE ARE ENGAGED WITH
THEM.
WE ARE MORE AND MORE TRYING TO
BUILD INTO THIS INITIATIVE,
SENSE OF COMMUNITY PARTICIPATION
SO THAT WHEN AN INITIATIVE IS
OUT ON THE STREET AS WE CALL IT,
WHAT IS IT THAT THE COMMUNITY
ITSELF THINKS IS AN IMPORTANT
APPROACH OR RESEARCH QUESTION OR
OUTCOME THEY WOULD LIKE TO SEE.
FROM THE PROPOSED RESEARCH.
ALSO JUST SORT OF DAY-TO-DAY
ENGAGEMENT IN THE SCIENCE OFTEN
LEADS TO ENCOUNTERS TO PEOPLE
WITH IDEAS AND SO WE'RE ALWAYS
INTERESTED IN HEARING WHAT
PEOPLE HAVE TO SAY.
FROM TIME TO TIME ESPECIALLY FOR
QUITE LARGE INITIATIVE WE WILL
ISSUE WHAT'S CALLED A REQUEST
FOR INFORMATION WHICH IS WHERE
SOMETHING GOES OUT PUBLICLY AND
SAYS NICHD IS INTERESTED IN YOUR
THOUGHTS ABOUT A POTENTIAL
INITIATIVE OR PROGRAM TO ADDRESS
A CERTAIN TOPIC AND WE WILL PUT
THOSE OUT, GATHER UP THE
INFORMATION AND USE THAT TO
CONDUCT OUR PLANNING PROCESSES.
>> VERY UPONFUL.
THANK YOU.
>> THANK YOU SO RESEARCH FOR AN
INTERESTING PROSENTATION, YOU
MAY HAVE SAID IT, YOU SHOWED
THAT WONDERFUL SLIDE WHAT'S OLD,
WHAT'S NEW, WHAT IS THE TINY
PERCENTAGE SLIVER THERE AT THE
TOP?
>> I HAD A FEELING I WOULD GET
THIS QUESTION.
THE SLIVERRA THAT IS LEFT IS 2%.
OF THE TOTAL APPROPRIATION FOR
20
2021.
>> THANK YOU VERY MUCH.
THAT'S VERY HELPFUL.
>> ANY OTHER QUESTIONS?
WE'RE RUNNING JUST SLIGHTLY
BEHIND.
THE OTHER THING I WANTED TO
POINT OUT, WELL, THERE ARE 2
THINGS I WANT TO POINT OUT.
FIRST OF ALL IT'S CRUCIAL THAT
OUR PROGRAM STAFF STAY CURRENT
WITH THE SCIENCE.
SO THAT IS WHY WE ENCOURAGE THEM
TO TRAVEL TO AND PARTICIPATE IN
SCIENTIFIC MEETINGS THAT ARE
RELEVANT TO THE AREAS IN THEIR
PARTICULAR PORTFOLIO.
SO, THEY'RE NOT DISCONNECTED
FROM WHAT IS BEING DISCUSSED.
BUT, ON THE OTHER HAND, THERE IS
A 3 YEAR TIMELINE WHICH TROUBLES
ME AND OTHER PEOPLE.
WE WANT TO BE AS CURRENT AND AS
NIMBLE AS POSSIBLE SO, I THINK
THIS IS 1 OF THE AREAS WHERE FOR
EXAMPLE REBEKAH, RASOOLEY'S
OFFICE WILL HELP US CONTROL THE
AREAS WE CAN CONTROL AND SHORTEN
THE TIMELINE SO THAT OUR SCIENCE
WILL BE MORE TIMELY.
I MEAN WE DON'T WANT TO FUND
SMLG IN WHICH THE TOPIC HAS
ALREADY BEEN ADDRESSED AND
NUNDED AND THE ANSWER'S ALREADY
KNOWN FOR EXAMPLE, SO THAT'S
JUST MY TWO-CENTS AND AGAIN,
PEOPLE ARE PUTTING COMMENTS IN
THE CHAT BOX BUT WITHOUT FURTHER
ADO SO WE STAY REASONABLY
ON-TIME WE NOW HAVE A
PRESENTATION BY DR. ALLISON
CERNICH NICHD'S VERY OWN DEPUTY
DIRECTOR WHO WILL PRESENT PUB
LIKELY SOME OF THE WORK THAT HAS
BEEN DONE ON FUNCTIONALLY
REORGANIZING THE DIVISION OF
EXTRAMURAL ACTIVITIES AND THE
DIVISION OF EXTRAMURAL RESEARCH.
SO ALLISON AGAIN, APOLOGIES THAT
I FLIPPED THE ORDER BUT I THINK
THIS WILL WORK OUT PERFECTLY.
>> NO THIS, IS PERFECT AND I
THINK THIS ALSO SPEAKS TO SOME
OF THE DIVISION OF
RESPONSIBILITIES THAT CAROLINE
WAS TALKING ABOUT AND I THINK
YOU'VE HEARD A LOT ABOUT OUR
BUDGET AND OUR PROCESS AND THIS
IS A PROCESS THAT WE UNDERTOOK
ACTUALLY INTERESTINGLY START
NOTHING 2020, WHERE WE WERE
LOOKING AT OUR ORGANIZATION AND
TRYING TO DETERMINE, YOU KNOW
HOW DO WE BETTER SPLIT UP WORK,
HOW DO WE MAKE SURE THAT THINGS
ARE FUNCTIONING WELL, AND IT WAS
AROUND THE TIME THAT WE KNEW
THAT DR. DELAHON WAS RETIRING
AND WE SAW AN OPPORTUNITY TO
REORGANIZE PART OF NICHD TO
MAYBE POTENTIALLY ADDRESS
CONCERNS THAT PEOPLE RAISED AND
YOU KNOW IMPROVE OUR FUNCTION.
SO THIS IS SOMETHING THAT WE
WORKED ON TOGETHER.
THE OTHER THING JUST FOR
EVERYBODY'S AWARENESS IS THIS
PRESENTATION IS PART OF A
REQUIREMENT WE HAVE WHEN WE DO A
REORGANIZATION WITHIN THE
FEDERAL GOVERNMENT, WITHIN HHS,
THAT IS REQUIRED AND THERE WILL
ALSO BE A CONGRESSIONAL
NOTIFICATION AFTER WE FINISH
THIS PART OF THE PROCESS.
SO THIS IS THE FIRST OF 2 PUBLIC
OPPORTUNITIES TO COMMENT.
SO IF WE CAN GO TO THE NEXT
SLIDE.
I'M GOING TO GO THROUGH TODAY,
THE BACKGROUND, WHY WE DID THIS,
THE PROCESS, THE RESULTS, OUR
PROPOSALS, TO YOU ALL AS THE
PUBLIC, AND THEN I'M GOING TO
ASK FOR YOUR FEEDBACK.
I ALSO WANT TO ALERT PEOPLE THAT
ARE ON THE VIDEOCAST THAT WE DO
HAVE FOR THIS PRESENTATION
YOU'RE HEARING ON ZOOM THAT WE
ALSO HAVE THE CHAT BUT ALSO ON
THE VIEDMANIOY CAST THERE'S THIS
BOX UNDER THE VIDEO SCREEN IT
SAYS SEND LIVE FEEDBACK SO THIS
IS AN OPPORTUNITY FOR PUBLIC
FEEDBACK FOR THOSE WHO ARE ON
THE VIDEOCAST AS WELL, WE HAVE A
TEAM THAT WILL BE MONITORING
THAT BOX AND FEEDING ME
QUESTIONS FROM THE VIDEOCAST.
WE WILL ALSO HAVE A WEBINAR THEY
WILL TALK ABOUT LATER WHERE WE
WILL HAVE MORE OF A ZOOM
INTERACTION, SO IF THAT'S
PREFERRED FOR YOU, PLEASE TRY TO
MAKE THAT DATE.
WE WILL ALSO HAVE THE ABILITY TO
PROVIDE E-MAIL FEEDBACK.
SO NEXT SLIDE, PLEASE.
SO WHY A FUNCTIONAL
REORGANIZATION AND WHAT'S A
FUNCTIONAL REORGANIZATION.
SO WHEN I WAS WORKING IN THE
DEPARTMENT OF DEFENSE, I LEARNED
ABOUT FUNCTIONAL REORGANIZATIONS
AND FUNCTIONAL REORGANIZATIONS
ARE ESSENTIALLY WHAT IS THE
FUNCTION OF THE ORGANIZATION AS
IT STANDS NOW, ROLES AND
RESPONSIBILITIES FOR THE PEOPLE
WITHIN THE ORGANIZATION AND THEN
HOW ARE THEY--HOW ARE THEY PUT
TOGETHER SO THAT THE GROUP WORKS
AS A WHOLE AND THEY WORK MORE
EFFICIENTLY AND THAT, YOU KNOW
YOU ADDRESS ANY PROBLEMS THAT
YOU'RE SEEING IN TERMS OF MAKING
THE ORGANIZATION PERFORM BETTER
AND SO WE TOOK THAT APPROACH AND
WHAT WE LOOKED AT WITH SOME OF
THE PROBLEMS THAT WE HAD HEARD
OVER TIME.
ONE WAS THAT THE ASSOCIATE
DIRECTOR FOR THE DIVISION OF
EXTRAMURAL RESEARCH HAD A REALLY
HIGH NUMBER OF DIRECT REPORTS,
THE MANY YOU KNOW, THE MORE YOU
MANAGE, THE HARDER IT BECOMES TO
MANAGE YOUR DAY-TO-DAY SCHEDULE
AS WELL AS MAKING SURE THAT
YOU'RE ADEQUATELY SUPERVISING
ALL PERSONNEL.
AND THE LEVEL OF ASSETS IN OUR
MANAGEMENT.
WE HAVE ABOUT A BILLION DOLLARS,
1.1 BILLION DOLLARS IN GRANT
BUDGET TO FUND OUR EXTRAMURAL
RESEARCH AND THAT INCLUDED BOTH
THE SCIENTIFIC ADMINISTRATION AS
WELL AS GRANTS MANAGEMENT.
SO THE AWARDS, THE ONGOING
MONITORING, ET CETERA.
WE ALSO LOOKED AT THE
ORGANIZATION WITH RESPECT TO
CAREER DEVELOPMENT, SO WE WANTED
TO MAKE SURE THAT ALL EXTRAMURAL
STAFF HAD THE ABILITY TO ADVANCE
IN THEIR CAREER TRACKS AND THE
WAY THAT WE WILL ORGANIZE MADE
THAT A BIT LIMITED AND WE WANTED
TO MAKE SURE WE HAD CLINICAL
TRIALS OR SMALL BUSINESS
RESEARCH AND WE WERE DOING THAT
IN A BRASH BY BRANCH WAY WITH 1
BRANCH LEADING POTENTIALLY OR 1
PROGRAM OFFICIAL LEADING BUT
DIDN'T HAVE A COORDINATED EFFORT
THAT WOULD MAKE MAKE US MORE
EFFICIENT.
AND PROVIDE A POINT PERSON AND
THE OTHER IS THE LARGE AND
EXPECTED OR EMERGENCIES HAPPEN
AND NOW WE HAD THAT DISCUSSION
IN DISCUSSION OF 20.
THE OTHER WAS THAT THE
ORGANIZATION NEEDS TO BE THERE
FOR KEGZ EXPRESSION, WE KNOW
THEY COME INTO NICHD, THEY WILL
LOOK FOR OTHER OPPORTUNITIES AS
WELL, THEY HAVE A GROWTH
OPPORTUNITY OR NEARING
RETIREMENT AND THEY MAY HAVE TO
HAVE AN ORGANIZATIONAL SECTION
THAT PLANS FOR SUCCESSION.
SO THIS IS JUST A PROCESS AND A
BRIEF OVERVIEW OF FEBRUARY TO
MAY OF 2020 AND WE WENT THROUGH
AND LOOKEDDA THE NEEDS OF
FUNCTION RKSZ STRUCTURE AND
STAFFING OF THE DIVISION OF
EXTRAMURAL RESEARCH AND THIS IS
OUR ENVIRONMENTAL SCAN AS YOU
WERE.
THEN YOU DO THE ORGANIZATIONAL
STRUCTURE REVIEW, SO WE LOOKEDDA
THE OUR STRUCTURE AND STAFFING
WAS SX HEAT THEN IN NOVEMBER OF
2020 WE WENT TO DR. BIANCHI, AND
WE DID A PROPOSED DISTRIBUTION
SO WE GAVE DR. BIANCHI, A NUMBER
OF OPTIONS FOR HER TO LOOK AT
WITH RESPECT TO HOW WE COULD BE
ORGANIZED AND THEN SHE TOOK THE
OPPORTUNITY TO MEET WITH EACH OF
THE LEADER WITHIN THE DIVISION
WHO ARE REPRESENTING THEIR STAFF
TO GET THEIR INDIVIDUAL OPINION
ON THOSE SPECIFIC SPECIFIC
STRUCTURES AND WHAT THEY THOUGHT
WOULD BE THE BEST OPGDZ, THIS IS
A FAIRLY LENGTHY OPTION BUT WHAT
I APPRECIATED ABOUT THIS IS I
GOT TO KNOW THE DIVISION
INCREDIBLY WELL, THE HISTORY OF
THE ORGANIZATION, WHY THINGS
WERE DONE CERTAIN WAYS, WHAT
WORKED, WHAT DIDN'T WORK, WHAT
WE SHOULDN'T BREAK WAS ANOTHER
BIG PART OF THE DISCUSSION,
SOMETHING THAT WAS WORKING
REALLY WELL, SHOULD WE BREAK IT,
AND YOU KNOW GENERALLY THE
ANSWER TO THAT IS NOT BROKE
DON'T FITIONZ IT AND SO WE
REALLY TRIED TO LOOK FROM A
PROCESS PERSPECTIVE AS TO WHAT
WOULD WORK THE BEST AND GIVE
OPPORTUNITY, NEXT SLIDE, PLEASE.
SO THE CURRENT STRUCTURE WE HAVE
NOW, AND THIS IS OUR OVERARCHING
OARG CHART AND UNDER THAT WE
HAVE OUR DIVISION OF INTRAMURAL
RESEARCH, NATIONAL CENTER FOR
MEDICAL REHABILITATION RESEARCH
AND DIVISION OF EXTRAMURAL
RESEARCH.
IN ACCIDENT SLIDE, PLEASE.
SO WE WILL HAVE THE DIVISION OF
EXTRAMURAL ACTIVITY, SO THIS
WILL BE AN EXTRAMURAL COMPONENT
THAT WILL REPORT TO THE OFFICE
OF THE DIRECTOR OF SPECIFICALLY
REPORT TO THE DEPUTY DIRECTOR.
AND AND I WILL GO TO THE NEXT
SLIDE, SO THIS IS WHAT THE
CHANGE REALLY NEEDS.
SO WHAT IT USED TO BE IS A LOOK
OF THE DIVISION.
WE'RE REPORTING TO THE DIRECTOR
OF THE DIVISION OF EXTRAMURAL
RESEARCH, THAT INCLUDED THE
SCIENTIFIC REVIEW BRANCH, THE
OFFICE OF EXTRAMURAL POLICY AND
I WILL MAKE 1 OTHER NOTE THAT IN
THIS REORGANIZATION, WE ALSO
ASKED IF ANY BRANCHES WANTED TO
CHANGE THEIR NAME BECAUSE WE CAN
DO NAME CHANGES WITHIN THE
POLICY AND THE REASON THAT THE
DEVELOPMENTAL BIOLOGY OF THE
BRANCHES IN BLUE IS BECAUSE WE
WILL PROPOSE A NAME CHANGE
THROUGH THAT BRANCH.
I APOLOGIZE THIS SMALL ABOUT
THIS IS THE OFFICIAL
ORGANIZATIONS CHARITY THIS WILL
BE OFFICIALLY ON THE WEBSITE.
THE PROPOSED IS THAT WE HAVE A
DIVISION OF EXTRAMURAL RESEARCH,
THIS IS ALL THE SCIENTIFIC
BRANCHES THAT WILL REPORT TO
THAT OFFICE OF THE DIRECTOR, THE
DIVISION OF EXTRAMURAL RESEARCH
AND THAT WE WILL REVIEW THE
SCIENTIFIC AND OFFICE POLICY TO
THE DIRECTOR OF THE DIRECTOR FOR
THE DIVISION OF EXTRAMURAL
ACTIVITY.
WELL WHAT THIS ALLOWS US TO DO
IS NUMBER 1 NEEZ WILL STILL BE
COORDINATED SO THAT'S ALWAYS A
CONCERN THEY WILL TELL YOU
FUNCTIONALLY RIGHT NOW,
DR. RASOOLEY, AND COLLEAGUES ARE
COORDINATING PRETTY CLOSELY IN
HOW THIS WILL WORK BUT WE WILL
HAVE FOCUS MANAGEMENT OF ALL THE
GRANTS UNDER MANAGEMENT AND NOT
JUST THE SCIENTIFIC PROCESS THAT
YOU TALKED ABOUT, THEY WILL BE
PART OF THAT BUT WHAT THEY'RE
MAKING SURE OF IS THAT OUR
REVIEW CYCLES ARE MOVING AND
THERE'S FOCUS TO THOSE AND WE'RE
DOING THAT WITH DUE DILIGENCE
AND WORKING ON OUR PROCESSES
WITH THE CENTER FOR SCIENTIFIC
REVIEW AND HOW OUR GRANTS GET
REFERRED TO US ET CETERA AND WE
WILL ALSO HAVE A SIGNIFICANT
FOCUS ON GRANTS MANAGEMENT AND
HOW THAT CAN MOVE THROUGH
PUBLICATION AND DIFFERENT WAYS
WE CAN USE MECHANISM SO WE SORT
OF BRING THE PROCESS OF
EXPERTISE TO BEAR IN A FOCUSED
WAY AND IN THE DIVISION OF
EXTRAMURAL RESEARCH WILL BE IN A
FOCUSED WAY LOOKING AT THE
SCIENCE, WHAT ARE WE GOING TO
TRY TO MOVE FORWARD, WHAT ARE WE
GOING TO FUND, WHAT
OPPORTUNITIES WE HAVE FOR
CONVENING PER PUBLIC INPUT, ET
CETERA SO I THINK THESE ARE
REALLY EXCITING WAYS THAT WE CAN
TRY TO NARROW OUR FOCUS A BIT
AND ENSHIRR THESE PROCESSES ARE
BEING MANAGED IN A FOAMUSSED
WAY.
NEXT SLIDE, PLEASE.
SETHIS IS THE PROPOSED.
THE OTHER THINK THIS I WOULD
NOTE AND THIS IS SMALL BUT THE
RENAMING WILL BE FOR DBSC AND
THEY WILL DWK DEVELOPMENTAL
BIOLOGY AND CONGENITAL ANOMALIES
BRANCH.
THAT IS THE PROPOSAL. THIS IS
YOUR NEXT SLIDE.
THIS IS THE OPPORTUNITY FOR
PUBLIC COMMENTS, INPUT OR
QUESTIONS.
WE HAVE A SECOND PUBLIC MEETING
AND I WILL ASK SOMEBODY TO PUT
THIS IN THE CHAT, I THINK IT'S
JULY 12 I THOUGHT IT WAS IN THE
SLIDE BUT APPARENTLY I DID NOT
SO WE WILL ALSO TAKE COMMENTS
VIA E-MAIL TO THIS ADDRESS AND
OBVIOUSLY THESE SLIDES WILL BE
MABEL AVAILABLE AS WELL BUT IF
YOU CAN E-MAIL THEM AT
NICHD.GOV, WE CAN TAKE THOSE
COMMENT INTOS CONSIDERATION AND
PUT PUT THAT IN CONSIDERATION
WHEN WE SUBMIT THIS
ORGANIZATIONAL PACKAGE FOR HHS
CLEARANCE.
AND THEN CONGRESSIONAL
NOTIFICATION OF THE OFFICIAL
ORGANIZATION CHANGE.
SO I WILL CHECK THE CHAT HERE TO
SEE IF ANYONE HAS ANY QUESTIONS
AND AGAIN YOU CAN E-MAIL
QUESTIONS SO WE CAN HAVE
QUESTIONS AND COMMENTS, THE
SECOND HEARING IS PLANNED AT
YELL 12th AT 1 P.M. SO AGAIN
THAT WILL BE ANOTHER OPPORTUNITY
WHERE WE WILL PUBLICIZE THAT AS
WELL.
AND WE DO THESE PUBLIC HEARINGS
TO GIVE PEOPLE THE OPPORTUNITY
TO LET US KNOW IF THEY HAVE ANY
OPPOSITION OR CONCERN ABOUT THE
ORGANIZATIONAL CHANGE THAT WE'RE
MAKING.
>> AND THERE ARE CURRENTLY NO
QUESTIONS, IN THE CHAT OR IN THE
E-MAIL BOX.
THANKS JESSICA.
BACK TO YOU CATHY.
>> THANKS ALLISON FOR A GREAT
PRESENTATION.
JUST CURIOUS ABOUT THE NAME
CHANGE AND THE AREA THAT IT'S
OUT OF MY EXPERTISE BUT ANOMALY
IS SOMETHING THAT'S BAD AND
VARIATION VERSUS THE WHOLE RANGE
SO I WAS CURUOUS ABOUT THE
RATIONAL ON THAT.
>> I'M WONDERING SO I THINK THIS
WAS A POINT OF DISCUSSION AND I
DON'T KNOW IF JAMES
[INDISCERNIBLE] IS ON.
THIS WAS A POINT OF INTERNAL
DISCUSSION FOR US.
I THINK THERE IS A IT DID NOT
CAPTURE NECESSARILY THE CURRENT
THINKING ON HOW CONGENITAL
ESEXER SENTIALLY BIRTH DEFECTS
WITH THE PREVIOUS WORD, WE CAN
CHANGE TO STRUCTURAL VARIATION
BUT IT DIDN'T REALLY CAPTURE
WHAT WE WERE TRYING TO DIRECT
THERE BUT I BELIEVE THAT
CONGENERATEDETTAL ANOMALIES WAS
A BETTER WAY OF DISCUSSING IT
BECAUSE JUST LIKE THE
REHABILITATION FIELD, CATHY, A
DEFECT IS SORT OF A PERSON'S
DEFICIENCY REFERENCE RATE AND SO
I THINK THE CURRENT VERBIAGE
RIGHT NOW IS MORE CONSISTENT
CONGENERATEDETTAL ANOMALIES,
DIANEA ANY OTHER THOUGHTS ON
THAT.
I CAN WEIGH IN AND TONY CAN WAY
IN AS ANOTHER GENETICIST.
BUT NOBODY REALLY--YOU KNOW
STRUCTURAL VARIATION WAS SO WOKE
TO THE POINT THAT NOBODY REALLY
KNEW WHAT THAT MEANT, YOU KNOW
IS IT VARIATION IN DNA, I MEAN
IT JUST--DIDN'T REALLY CONVEY
THE PURPOSE OF THAT--OF RESEARCH
BEING PERFORMED THAT IS FUNDED
BY THAT DIVISION, AND SO THAT
DIVISION REALLY HAS A PORTFOLIO
IN DEVELOPMENTAL BIOLOGY WHICH
IS VERY CLEAR BUT WE WANTED TO
MAKE THE ARC TO PEOPLE WHO ARE
BORN WITH DEVELOPMENTAL PROBLEMS
THAT SPECIFICALLY AFFECT
STRUCTURES OTHER THAN THE BRAIN.
AND THE TERM MOST PEOPLE USE IN
GENETICS IS ANOMALIES.
TONY DO YOU WANT TO COMEBT ON
THAT AS WELL.
>> I AGREE THAT'S THE
TEMPERATURE THAT'S USED SO IT
MAKES IT CLEAR WHAT WE'RE
TALKING ABOUT FOR THE PERVIEW OF
THIS DIVISION, I TOTALLY AGREE
DIANEA.
>> THANKS, LUCK SEASKING HOW
THIS ALIGNS WITH THE STRUCTURE
AT OTHER INSTITUTES AND I THANK
YOU FOR THAT QUESTION, WHAT WE
DID TO START OFF AND DID THAT
FUNCTIONAL ANALYSIS AND WE DID
LOOK AT THE STRUCTURE OF A
NUMBER OF THE OTHER INSTITUTES
WE WERE 1 OF THE VERY FEW
INTUITIES THAT DID NOT HAVE A
DIVISION OF EXTRAMURAL ACTIVITY,
THEY'RE ALL NAMED SOMETHING
SLIGHTLY DIFFERENT BUT MOST OF
THE INSTITUTES HAVE SPLIT, AND
THEY HAVE 1 SECTION THAT DOES
MORE OF THE SCIENTIFIC REVIEW,
GRANTS MANAGEMENT, POLICY AND
TRAINING POLICY, ET CETERA?
AND SO, WE ACTUALLY ARE MORE NOW
IN ALIGNMENT WITH THE OTHER
ICs.
LET ME GO TO MELISSA AND LET ME
TAKE THE QUESTIONS FROM
VIDEOCAST AND THEN GO TO SHERRY.
>> QUICK QUESTION, SINCE YOU'RE
ON THE TOPIC OF SORT OF THE
RATIONAL FOR THIS, FOR THIS
RESTRUCTURING, I UNDERSTAND THAT
OTHER ICs ALSO STRUCTURE
THEIR--IN THIS WAY, THAT'S
GREAT, BUT I WAS WONDERING IF
THIS RESTRUCTURING ALSO
ADDRESSES MAYBE GAPS OR ISSUES
THAT YOU ALL IDENTIFIED DURING
YOUR FUNCTIONAL ANALYSIS IS
STRUCTURAL REVIEW.
>> THE BIGGEST THING IS
ADDRESSES IS, 1 IS THE D. E. R.
WITH HAVING DIVISION DIRECTOR
FOR D. E. R. WAS HAVING TO
REALLY LOOK AT ALL THE THINGS,
RIGHT?
NOT JUST LIKE WHAT THE
SCIENTIFIC PRIORITIES WERE AND
WHAT WAS--WHAT EACH BRANCH WAS
WORKING ON AND THE WORKSHOPS AND
THE FOAs AND ALL OF THOSE
THINGS, BUT THEY'RE ALSO HAVING
TO PAY ATTENTION TO WHAT WERE
THE NEEDS OF GRANTS MANAGEMENT
AND WHAT DID THEIR TECHNICAL
FOLKS NEED, WHAT TRAININGS DID
THEY NEED, WHAT OPPORTUNITIES
DID THEY NEED?
WHAT WAS THEIR CALENTAR LIKE?
SO AS WE'RE PUSHING THROUGH THE
FISCAL YEAR, THEY HAVE NEEDS
THAT THEY NEED TO PAY ATTENTION
TO, SAME FOR REVIEW. AND WHAT I
THINK THIS REALLY DID IS IT
CREATED A BETTER MANAGEMENT OF A
MANAGEMENT STRUCTURE FOR US TO
DO THAT, REALLY PAY ATTENTION TO
THE WHOLE EXTRAMURAL
ORGANIZATION, THE OTHER IS IT
CREATED A NEW EXECUTIVE POSITION
SO WE HAVE MORE GROWTH UP THE LA
LADDER, IT CREATED NEW STAFF
ASSISTANT POSITIONS SO FOR OUR
FOLKS THAT PROVIDE SUPPORT FOR
EACH OF OUR BRANCHES THERE ARE
ADVANCEMENT OPPORTUNITIES TO
HIRE GS LEVELS NOW AND THAT
PROVIDES EQUITY ACROSS THE
SCIENTIFIC AND ADMINISTRATIVE
BRANCH.
WE WILL NEVER GET TO FULL EQUITY
AND BUT AT LEAST GIVING MORE
OPPORTUNITY IN THE DIFFERENT
LINE.
SO WE REALLY DID TRY TO ADDRESS
THE NUMBER OF THOSE FUNCTIONAL
CONCERNS IN THIS THIS, IS A
BROAD OVERVIEW OF A 6 MONTH
PROCESS THAT FOLKS IN D. E. R.
HAD TO SUFFER THROUGH WITH ME,
BUT I THINK WE GOT TO SOME GOOD
CONSENSUS, ON WHAT THIS WOULD
PROVIDE.
SOT LE ME TAKE QUESTIONS FROM
THE LIVE VIDEOCAST.
>> THE FIRST 1 COME NOTHING IS
FROM DR. MALDONADO, IS THERE
SUFFICIENT STAFF FOR THE
REORGANIZATION?
>> PART OF THE PROPOSAL, THANK
YOU FOR THE QUESTION.
SO MORE AND MORE, RIGHT?
THERE ARE SUFFICIENT STAFF
AND/OR WE BUDGETED FOR THE
INCREASE NEED FOR STAFF.
I WILL TELL YOU THAT I WILL SAY
THE DOCTOR BIANCHI, AND NICHD IS
LEAN, AND SOMETIMES LEAN TO THE
POINT WHERE MAYBE WE'RE NOT
FUNCTIONING AS EFFECTIVELY WE
COULD AND DOING WAWE NEED TO
BECAUSE WE'RE TRYING TO BE SO
LEAN THAT WE CAN BURN OUR PEOPLE
OUT AND SO 1 OF THE COMMITMENTS
WE MADE WHEN WE DID THIS WAS TO
MAKE SURE WE COMILTED THE
NECESSARY RESOURCES FOR THE
STAFFING.
BECAUSE, YOU KNOW YOU'RE GOING
TO NEED TO BUILD OUT SOME OF
THIS TO MAKE IT REALLY WORK.
WHAT WE HOPE IS IT MAKES US MORE
NIMBLE AS AN ORGANIZATION AND IF
WE DO LOSE STAFF THAT WE CAN
COVER DOWN OR IF THERE'S AN
EMERGENCY THAT WE'RE NOT, YOU
KNOW I CAN'T TELL YOU ALL HOW
HARD PEOPLE HAVE WORKED DURING
COVID, I JUST CAN'T BECAUSE THEY
WERE ESSENTIALLY DOING 2 JOBS
AND I KNOW YOU FELT THE SAME
WAY, BUT WE WANT TO MAKE SURE
THAT WE HAVE THE SUPPORTS IN
PLACE FOR FOLKS SO THAT CAN HAVE
SOME BALANCE AND THEY ARE NOT
KILLING THEMSELVES.
AND SO, THAT WAS ANOTHER
COMMITMENT WE MADE DURING THIS
TO MAKE SURE WE HAD QUICK
RESOURCES FOR THAT, SO IT WAS
PART OF THE PROPOSAL.
>> YOU WANT TO GIVE ME THE NEXT
QUESTION AND I WILL MOVE TO
DR. BERKINS.
>> SURE, WILL CONGENITAL
STRUCTURAL DEFECTS STILL BE THE
FOCUS OF THE BRANCH AFTER THE
NAME CHANGE?
>> CORRECT.
THANK YOU, THAT IS ALL THE
QUESTIONS WE RECEIVED.
>> PERFECT SO SHERRY AND THEN I
WILL MOVE TO THE OTHER QUESTION
IN THE CHAT.
>> I DON'T ACTUALLY HAVE A
QUESTION, YOU'VE ANSWERED ALL OF
THEM.
THANK YOU SO MUCH.
>> I LOVE THAT.
PERFECT.
LET ME NIEWF TO A QUESTION IN
THE CHAT WHICH IS DID YOU
CONSIDER AN INCREASED NEEZ FOR
BEHAVIORIAL SOCIAL SCIENTIST
STAFF TO SUPPORT CROSS CUTTING
THEMES OF HEALTH DISPARITIES,
GREAT QUESTION, REBEKAH, SO
THERE'S COUPLE THINGS IN HEALTH
DISPARITIES ACROSS THE
ORGANIZATION THAT WE'RE REALLY
THINKING ABOUT SO WE, NUMBER 1
WE ARE HAVING A CONVERSATION
ABOUT SOCIAL SCIENTISTS AND I AM
WORKING WITH DR. HAZRAH ON 1
SPECIFIC REQUEST THAT MAY BE
COMING FORWARD FOR THOSE STAFF
AND I THINK WE'RE ALSO TRYING TO
FIGURE OUT HOW TO BETTER
INTEGRATE BEHAVIORIAL AND SOCIAL
SCIENCE STAFF ACROSS OUR
INITIATIVES.
I MEAN I THINK IT'S BEEN GREAT
TO WATCH SOME OF OUR MORE
BEHAVIORIAL FOLKS REALLY GETTING
INVOLVED WITH INITIATIVES FOR
EXAMPLE, LIKE THE BRAIN
INITIATIVE AND REALLY PUSHING
SOME INCLUSION IN THAT--IN THAT
SPECIFIC INITIATIVE, SO I'VE
REALLY ENJOYED THAT QUITE A BIT.
WITH RESPECT TO HEALTH
DISPARITIES, THE STRATEGY IS A
BIT DIFFERENT AND IT'S GOING TO
BE--WE WILL UPDATE YOU ABOUT
THAT HOPEFULLY SOON.
AS YOU ALL KNOW DR. LAMAR LEFT
IN JANUARY AND IT'S NOT PART OF
THIS REORGANIZATION.
RIGHT NOW I'M THE ACTING
DIRECTOR OF THE OFFICE OF HEALTH
EQUITY SO I'M DEVELOPING THE
STRATEGY FOR HOW WE ARE GOING TO
BETTER ADDRESS HEALTH
DISPARITIES ACROSS THE
ORGANIZATION.
WE HAVE MADE SOME SIGNIFICANT
MOVES ON THAT BUT WILL ALSO BE
MAKING A NEW HIGHER, HOPEFULLY
IN THE COMING WEEKS TO MONTHS
FOR DR. LAMAR'S POSITION AND
WE'RE ALSO THINKING ABOUT OUR
ORGANIZATIONAL STRATEGY ACROSS
INTRAMURAL, EXTRAMURAL AND OUR
ADMINISTRATIVE MANAGEMENT
DIVISION OFFICE OF
ADMINISTRATIVE MANAGEMENT THAT
MR. RIVERA IS RUNNING SO THAT WE
BETTER INTEGRATE ACROSS THE
ENTIRE ORGANIZATION AND WE HAVE
A WAY TO PUSH OUR EQUITY
DIVERSITY INCLUSION AND
ACCESSIBILITY INITIATIVE FOR ALL
THE DIVISIONS NOT JUST THE
SCIENTIFIC DIVISIONS.
BECAUSE WE NEED IT TO CROSS
EVERYTHING.
SO, MORE TO COME ON THAT, I HOPE
BY SEPTEMBER WE WILL HAVE
SOMETHING TO SHARE WITH YOU AT
LEAST IN THE INITIAL.
>> THANK YOU.
>> GREAT.
WELL, WE ARE JUST ABOUT AT TIME
SO, THANK YOU ALLISON FOR THAT
OUTSTANDING PRESENTATION.
THANK YOU ALL FOR YOUR QUESTIONS
AND ENGAGEMENT.
YOU'VE EARNED A 30-MINUTE BREAK,
ACTUALLY 29 MINUTES BUT WHO'S
COUNTING.
I WANT YOU TO COMBACK PROMPTLY
AT 3 FOR THE PRESENTATION BY
DR. SHANNON ZENK, WHO IS THE
RELATIVELY NEW DIRECTOR OF THE
NATIONAL INSTITUTE OF NURSING
RESEARCH.
AND YOU WILL--AS YOU WILL HEAR,
MANY OF HER PRIORITIES ALIGN
WITH OURS.
SO, TAKE YOUR BREAK, AND WE WILL
SEE YOU BACK PROMPTLY AT 3.
THANK YOU.
WELCOME BACK, EVERYONE IS
DR. ZENK WITH US?
I'VE BEEN LOOKING FOR HER.
THERE SHE IS, WELCOME.
>> THANK YOU.
>>GREAT, EVERYONE IS REFRESHED
AND I WOULD LIKE TO INTRODUCE
OUR NEXT PRESENTER WHO IS
DR. SHANNON ZENK, THE DIRECTOR
OF THE NATIONAL INSTITUTE OF
NURSING RESEARCH.
DR. ZENK WAS APPOINTED AS NINR'S
DIRECTOR IN SEPTEMBER OF 2020.
WOW IT'S ALREADY BEEN OVER A
YEAR.
HOW DID THAT HAPPEN?
SHE CAME ON OBVIOUSLY DURING THE
PANDEMIC.
SHE IS A REGISTERED NURSE, AND
LEADING NURSE RESEARCHER WHOSE
RESEARCH FOCUSES ON SOCIAL
INIQUITIES AND HEALTH WITH A
GOAL OF IDENTIFYING EFFECTIVE
MULTILEVEL APPROACHES TO IMPROVE
HEALTH AND ELIMINATE RACIAL AND
ETHNIC AS WELL AS SOCIOECONOMIC
HEALTH DISPARITIES.
HER RESEARCH PORT NOALIO
INCLUDES WORK INTO URBAN FOOD
ENVIRONMENTS, COMMUNITY HEALTH
SOLUTIONS AND VETERANS HEALTH.
WE LOOK FORWARD TO HEARING MORE
FROM DR. ZENK ABOUT NINR'S
RESEARCH PRIORITIES AND THEIR
BRAND NEW STRATEGIC PLAN.
>> THANK YOU DIANE ASUCH A BLUSH
TO BE WITH YOU.
GOOD AFTERNOON TO EVERYONE.
I WILL SHARE MY SCREEN AND LET
ME KNOW IF I DON'T GET IT QUITE
RIGHT.
BUT AGAIN IT'S A PLEASURE TO BE
WITH US AND I AM EXCITED TO TELL
YOU ABOUT NINR'S NEW STRATEGIC
PLAN AND TO START A CONVERSATION
ABOUT OUR OUR INSTITUTES MIETD
EXPAND OUR COLLABORATIONS TO
ACHIEVE OUR MUTUAL GOALS.
SO GOOD AFTERNOON TO EVERYONE.
TODAY I WILL SHARE WITH YOU SOME
BACKGROUND ON NINR AND OUR NEW
STRATEGIC PLAN.
SOME OF THE WAYS THAT NINR
COLLABORATING ACROSS THE NIH AND
BEYOND AND SHARE A BIT ABOUT
SOME SELECTED NINR FUNDED
RESEARCH STUDIES AND CERTAINLY I
HOPE WE HAVE TIME TO TALK MORE
ABOUT HOW OUR INSTITUTES MAY
WORK TOGETHER.
BUT BEFORE I BEGIN LET ME TELL
YOU A LITTLE BIT ABOUT NINR FOR
THOSE WHO ARE NOT AS FAMILIAR
AND THE IMPORTANCE OF NURSING
SCIENCE TO HEALTH AND WELL
BEING.
NINR WAS FOUNDED TO--AS AN NIH
CENTER IN 1985 AND WAS ELEVATED
TO INSTITUTE STATUS IN 1993.
AND SINCE IT'S FOUNDING NINR
SCIENCE HAS SUPPORTED RESEARCH
THAT DEVELOPS THE SCIENTIFIC
BASIS FOR CLINICAL PRACTICE AND
POLICY.
WE THINK THAT SETS NINR APART
FROM OTHER NIH INSTITUTES IS
THAT OUR RESEARCH WITH NURSING'S
PERSPECTIVE AT ITS CORE IS
FOCUSED ON HEALTH SOLUTIONS FOR
PEOPLE IN THE CONTEXT OF THEIR
LIVES AND LIVING CONDITIONS.
NURSES ARE EVERYWHERE, IN OUR
HOSPITALS AND CLINICS, BUT ALSO
IN OUR SCHOOLS AND WORKPLACES,
IN HOMES, IN CRIMINAL JUSTICE
SETTINGS, AND THROUGHOUT OUR
COMMUNITIES.
WE OPROACH PREVENTION, TREATMENT
AND CARE WHOLISTICALLY AND IN
CONTEXT AND THE SCOPE OF OUR
PRACTICE AND THE BREDTH OF OUR
KNOWLEDGE SPANS THE LIFE COURSE,
CROSSES DISEASES AND CONDITIONS
AND EXTENDS FROM IMPROVING THE
HEALTH OF INDIVIDUALS TO THAT OF
ENTIRE POPULATIONS.
IT'S THIS UNIQUE PERSPECTIVE AND
POSITIONING THAT MAKES NURSING
SCIENCE SO WELL SITUATED TO LEAD
RESEARCH FOCUSED ON THE WHOLE
PICTURE OF HEALTH, FROM THE
BIOLOGY OF A PERSON'S CELLS IN
GENES TO THEIR WHOLE SELF,
FAMILY, RESOURCES AND THE
COMMUNITY AND SOCIETY IN WHICH
THEY LIVE.
NURSING'S EARLIEST PIONEERS
RECOGNIZE THAT HEALTH SMUOF THE
BE CONSIDERED WITHIN THE CONTEXT
OF PEOPLE'S LIVES AND LIVING
CONDITIONS.
IN OTHER WORDS THEY WERE AMONG
THE EARLIEST TO INCORPORATE
SOCIAL DETERMINANTS INTO THEIR
SOLUTIONS TO HEALTH PROBLEMS.
AND THE TASK OF ELIMINATING
INIQUITIES CAUSED BY SOCIAL
DETERMINANT SYSTEM NOTHING NEW
TO NURSES.
AND AT NINR WE ARE BUILDING ON A
RICH HISTORY THROUGH NURSE HEVER
LED EFFORTS TO ADDRESS
INTENSIFYING INIQUITIES AND
SOCIAL DETERMINANTS OF HEALTH
AND A RECENT FUTURE OF NURSING
REPORT MAKES A COMPELLING CASE
FOR NEW NURSE-LED MODELS TO
ADDRESS SOCIAL DETERMINANTS OF
HEALTH AND NEEDS ALL WITH THE
GOAL OF ACHIEVING HEALTH EQUITY.
SO WITH THAT, NURSING AND
NURSING SCIENCE CONTEXT IN MIND,
LET ME TURN TO NINR'S LATEST
STRATEGIC PLAN.
WE LAUNCHED OUR 2022, 2026
STRATEGIC PLAN JUST LAST MONTH
AND I AM EXSEATED TO TELL YOU
ABOUT IT.
AT NINR WE'RE COMMITTED TO
LEADING NURSING SCIENCE TO SOLVE
PRESSING HEALTH CHALLENGES AND
FORM PRACTICE AND POLICY,
OPTIMIZING HEALTH AND ADVANCING
HEALTH EQUITY INTO THE FUTURE.
OUR MISSION STATEMENT REFLECTS
OUR BELIEF THAT NURSING RESEARCH
IS THE KEY TO UNLOCKING THE
POWER AND POTENTIAL OF NURSING.
AND OUR STRATEGE BEING PLAN
DESCRIBES HOW WE WANT TO
LEVERAGE THE STRENGTHS AND
UNIQUE KNOWLEDGE AND
PERSPECTIVES INHERENT TO THE
DISCIPLINE TO THE BENEFIT OF ALL
PEOPLE.
THE STRATEGIC PLAN INCLUDES
GUIDING PRINCIPLES THAT IS
IMPORTANT QUALITIES THAT ALL
NINR SUPPORTED WORK SHOULD HAVE
GOING FORWARD.
IN CONSIDERING GRANT
APPLICATIONS FOR FUNDING, THE
EXTENT TO WHICH STUDIES REFLECT
THESE PRINCIPLES WILL BE A
FACTOR IN OUR DECISIONS.
WE NEED TO SUPPORT RESEARCH THAT
ADDRESSES TODAY'S CHALLENGES AND
HELPS US BE BETTER PREPARED FOR
THE FUTURE, DISCOVER SOLUTIONS,
TO OPTIMIZE HEALTH ACROSS
CLINICAL, COMMUNITY AND POLICY
SETTINGS.
ADVANCES EQUITY, DIVERSITY,
INCLUSION AND ACCESSIBILITY AND
IS INNOVATIVE APPLIES RIGOROUS
RESEARCH METHODS AND HAS TD
POTENTIAL FOR SIGNIFICANT IMPACT
ON HEALTH AND WELL BEING.
THE PLAN ALSO INCLUDES 5
RESEARCH LENSES, SO LET ME SMAIN
WHAT WE MEAN BY THAT TERM.
SIMPLY WHEN WE SAY A LENS WE ARE
PRESCRIBING A PERSPECTIVE, TO
EXAMINE THE HEALTH CHALLENGE IN
DEVELOPING OUR SCIENTIFIC
STRATEGY NINR IDENTIFIED 5
LENSES THAT WE THINK STRENGTHEN
NURSING AND SCIENCE TO INNOVATE,
THINK BIGGER AND GREATLY
INCREASE OUR IMPACT.
THE LENSES IN THE TRANSLATIONAL
RESEARCH TEEJIC PLAN ARE HEALTH
EQUITY, SOCIAL DETERMINANTS OF
HEALTH, POPULATION AND COMMUNITY
HEALTH, PREVENTION AND HEALTH
PROMOTION, AND SYSTEM SYSTEM AND
MODELS OF CARE.
SO I WILL GIVE YOU A CLOSER LOOK
AT EACH OF THESE LENSES.
AND OUR HEALTH EQUITY LENS AIMS
TO REDUCE AND ULTIMATELY
ELIMINATE THE SYSTEMIC
POPULATION GROUPS AT UNFAIR
UNSUPPORTED JUSTICE AND
AVOIDABLE DISADVANTAGE IN
OBTAINING THEIR FULL HEALTH
POTENTIAL.
FROM NINR'S PERSPECTIVE HEALTH
EQUITIES ARE ROOTED IN SYSTEMIC
AND STRUCTURAL FACTORS THAT
LIMIT ACCESS TO POWER,
OPPORTUNITIES AND RESOURCES.
THESE FACTORS INCLUDE STRUCTURAL
RACISM, AND CREATE BARRIERS TO
HEALTH AND CAN LEAD TO
PERSISTENT HEALTH INIQUITIES, SO
WE ARE INTERESTED IN SUPPORTING
NURSING RESEARCH THAT IMPROVES
HEALTH AND WELL BEING FOR ALL,
THROUGH STRUCTURAL INTERVENTIONS
THAT REMOVE OBSTACLES TO HEALTH,
INCREASE AVAILABILITY AND
ACCESSIBILITY OF RESOURCES AND
ALTER SOCIAL AND INSTITUTIONAL
NORMS.
OUR SECIAL DETERMINANTS OF
HEALTH LENS TAME AIMS TO E
DENTIFY APPROACHES TO IMPROVE
HELT AND QUALITY OF LIFE BY
ADDRESSING THE CONDITIONS IN
WHICH PEOPLE ARE BORN, LIVE,
LEARN, WORK, PLAY AND AGE.
FROM NINR'S SOCIAL DETERMINANTS
OF HEALTH THAT OOH DENTIFIES AND
DEVELOPS INTERVENTIONS DELIVERED
AT THE RIGHT PLACE AND RIGHT
TIME TO TARGET THESE SOCIAL
DETERMINANTS.
WE WANT OUR INVESTIGATORS TO
IMPROVE AND HEALTH EQUITY, AND
IDENTIFY HOW TO LIMIT EXPOSE
TOWER ADVERSE, SOCIAL AND
ECONOMIC CIRCUMSTANCES AND
CONSIDER HOW TO LIMIT
SUSCEPTIBILITY TO BIOLOGICAL AND
BEDDING OF DETERMINANTS OVER THE
LEFT COURSE AND ACROSS
GENERATIONS.
OUR POPULATION AND COMMUNITY
HELP LENS AIMS TO ADDRESS
CRITICAL HEALTH CHALLENGES AT A
MACROLEVEL THAT CONSISTENTLY
AFFECT PEOPLE CAN SHARED
CHARACTERISTICS, FROM OUR
PERSPECTIVE POPULATION HEALTH
REFERS TO THE HEALTH AND WELL
BEING OF GROUPS OF INDIVIDUALS
WITH 1 OR MORE SHARED
CHARACTERISTICS.
AND AS A SUBSET OF POPULATION
HEALTH, COMMUNITY HEALTH REFERS
TO HEALTH AND WELL BEING OF
THOSE 1 NECTED BY PLACE.
SO WE ARE VERY INTERESTED IN
RESEARCH THAT USES ETIOLOGIC
APPLIED AND TRANSLATIONAL
APPROACHES TO IDENTIFY RISK AND
PROTECTIVE FACTORS.
AND INVESTIGATES POPULATION AND
COMMUNITY HEALTH ETESTS AND
EVALUATES BOTH PLANNED AND
NATURAL EXPERIMENTS OF
MACROLEVEL INTERVENTIONS AND
USES COMMUNITY ACTION AND
PARTNERSHIPS IN THE MANY
SETTINGS IN WHICH NURSES WORK.
THE NEXT LENS AIMS TO PREVENT
DISEASE AND PROMOTE HEALTH
THROUGH THE CONTINUUM OF
PREVENTION.
FROM OUR PERSPECTIVE, PREVENTION
REFERS TO ACTIONS TAKEN TO
REDUCE THE DISEASE, OR INJURY
ALONG A CONTINUUM THAT BEGINS
WITH PRIMORDIAL PREVENTION WHICH
TARGETS THE UNDERLYING RISKS AND
CONTINUES ALL THE WAY TO
TERTIARY PREVENTION WHICH AIMS
TO REDUCE SYMPTOMS, SEVERITY AND
PROGRESSION.
AND HELGTD PROMOTION INCLUDES
EFFORTS TO FACILITATE HEALTHY
ABOUTY HAIEVERS THAT REDUCE
RISK, IMPROVE HEALTH, MANAGE
DISEASE AND ENHANCE WELL BEING.
SO WE ARE INTERESTED IN
SUPPORTING NURSING RESEARCH THAT
IDENTIFIES THE MECHANISMS
THROUGH WHICH INTERVENTIONS
WORK, MORE OVER PREVEPGZ AND
HEALTH PROMOTION EFFORTS MUST
AIM TO ELIMINATE HEALTH
INIQUITIES BY ACCOUNTING FOR THE
MYRIAD OF FACTORS FROM
BIOLOGICAL TO SOCIETAL THAT
AFFECT HEALTH.
AND OUR LAST LENS AIMS TO
ADDRESS CLINICAL ORGANIZATIONAL,
AND POLICY CHALLENGES THROUGH
NEW SYSTEMS AND MODELS OF CARE.
WE NEED INNOVATIVE SYSTEMS AND
MODELS OF CARE MADE UP OF
COALITIONS AND PARTNERSHIPS THAT
SPAN CLINICAL AND COMMUNITY
SETTINGS, AND ADDRESS SOCIAL
FACTORS AND NEEDS FOR
POPULATIONS, AND INDIVIDUALS.
WE ENCOURAGE NURSE-LED SYSTEMS
AND MODELS OF CARE THAT CONSIDER
HOW TO LEVERAGE THE MODEL'S
TRUST IN AND EXPERTISE OF THE
NURSING WORKFORCE TO EMPLOY
SOLUTIONS INFORMED BY NURSES
PERSPECTIVES AND EXPERIENCES AND
TO FOCUS ON HEALTH PROMOTING
CARE THAT ENCOMPASSES THE WHOLE
PERSON AND THE CONTEXT OF THEIR
LIVES AND LIVING CONDITIONS.
SO WE ARE COMMITTED TO NURSING
RESEARCH THAT INFORMS THE
DEVELOPMENT, DISSEMINATION AND
LIMP IMPLEMENTATION OF SYSTEMS
AND MODELS OF CARE AND GRAPPLES
WITH CHALLENGES SUCH AS
COORDINATING CARE AND
INTEGRATING DATA ACROSS CLINICAL
AND COMMUNITY SETTINGS.
TESTING MODELS OF CONTEXTUALIZED
CARE AND UNDERSTANDING THE IMENT
PACTS EVER ORGANIZATIONAL
PRACTICES AND POLICIES ON
QUALITY OF CARE AND ITS
OUTCOMES.
THESE LENSES ARE COMPLIMENTARY
AND SINNER GESTIC.
IN ADDITION TO STRENGTHS OF
NURSING RESEARCH, THE LENSES
PROVIDE MULTILEVEL APPROACHES,
KROS DISCIPLINEAR EXPE CROSS
SECTORAL COLLABORATION AND
COMMUNITY ENGAGEMENT AND
RESEARCH.
NOW AS SHOWN BY THIS RESEARCH
FRAMEWORK, NINR SUPPORTED
INVESTIGATORS HAVE THE
FLEXIBILITY TO APPLY A SINGLE
LENS OR COMBINATION OF LENSS AND
THEIR STUDY DESIGNS AND TRAINING
PROGRAMS.
SO WE ENCOURAGE RESEARCHERS TO
VIEW THE HEALTH EQUITY AND
SOCIAL DETERMINANTS OF HEALTH
LENSES AS PRIMARY FOCI THROUGH
WHICH TO CONSIDER THE OTHER 3
LENSES.
NINR'S RESEARCH LENSES WILL,A
LOW INVESTIGATORS TO CONSIDER A
FULL SPECTRUM OF NURSING
RESEARCH TOPICS, THAT ENCOMPASS
THE HEALTH AND ILLNESS OF
PEOPLEs LIVED EXPERIENCES.
THUS THESE LENSES WILL ALLOW
NURSES, SCIENTISTS AND OTHERS TO
EXAMINE NEW TOPICS WHILE ALSO
ALLOWING THOSE WITH LONG
STANDING PROGRAMS OF RESEARCH TO
TAKE A DIFFERENT LOOK AT THEIR
AREAS OF INTEREST.
MANY OF OUR LENSES BUILD ON
NINR'S INVESTMENT IN LONG
STANDING AREAS OF INTEREST, FOR
EXAMPLE, 43% OF NINR'S BUDGET
ALREADY SUPPORTS PREVENTION
RESEARCH.
THIRTY-FOUR% OF OUR BUDGET
FOCUSES ON RESEARCH TO ELIMINATE
HEALTH INIQUITIES AND 26% OF OUR
BUDGET FOCUSES ON SOCIAL
DETERMINANTS OF HEALTH.
SO YOU CAN FIND THE STRATEGIC
PLAN ON OUR WEBSITE.
WE DO CONSIDER THIS A LIVING
DOCUMENT WILL RESPOND TO QUICKLY
AND NIMLY TO EMERGING ISSUES AND
CRISIS.
WE BELIEVE IT'S BEST HOUSED ON
OUR WEBSITE.
NOW CHANGING TOPICS,
COLLABORATION IS VICAL TO NINR
AND ACCOMPLISHING THE
MISSIONINGS OF NINH AND EVERY
OTHER INSTITUTE AND CENTER, IN
SUPPORT OF NINR AND NIH'S
MISSIONS, WE'RE MAKING SURE THAT
NINR IS COLLABORATING WITH
PARTNERS, BOTH WITHIN NIH AND
ACROSS THE FEDERAL GOVERNMENT.
FOR EXAMPLE, WE ARE EXCITED TO
BE COLLABORATING ALONG WITH
NICHD, ON THE NIH WIDE CLIMATE
CHANGE AND HEALTH INITIATIVE
WHICH SUPPORTS RESEARCH TO
UNDERSTAND THE POTENTIAL HEALTH
BENEFITS OF ACTIONS TO PREVENT,
MITIGATE AND ADAPT TO CLIMATE
CHANGE ESPECIALLY FOR AT RISK
COMMUNITIES.
AND WE ARE PLEASED TO BE
CO-CHAIRING WITH NIMHD AND
OBSSR, A NEW NIH-WIDE SOCIAL
DETERMINANTS OF HEALTH RESEARCH
COORDINATING COMMITTEE.
WE ARE VERY GLAD TO HAVE NICHD
AS PART OF THE EXECUTIVE
COMMITTEE AS WELL AS PART OF THE
RCKRRK ITSELF.
NOW THE GOAL OF THE RCC, IS TO
ACCELERATE SOCIAL DETERMINANTS
OF HEALTH RESEARCH ACROSS NIH.
THIS INCLUDES ACROSS DISEASES
AND CONDITIONS, POPULATIONS,
STAGES OF A LIFE COURSE AND OF
COURSE SOCIAL DETERMINANTS OF
HEALTH DOMAINS.
THERE ARE 4 OBJECTIVES ISSUES
ONCE IS TO FACILITATE THE
SHARING OF INFORMATION ABOUT
THIS FIELD OF RESEARCH AND
SECOND IS TO DEVELOP THE
EXPERTISE CAPACITY AND THE
LEARNING SYSTEM AT NIH, WE ALSO
LOOK TO BUILD, COLLABORATIONS
ACROSS NIH, AND WITH OTHER
FEDERAL PARTNERS.
AND TO IDENTIFY IMPORTANT GAPS
AND PROMISING FUTURE RESEARCH
DREK, AND ALONG OUR OFFICES ARE
CO CHAIRING A NEW 10 YEAR
397 MILLION-DOLLAR NIH COMMON
FUND PROGRAM CALLED COMPASS.
COMPASS WE BELIEVE WILL BE
TRANSFORMATIVE AND HELP US TO
MAKE REAL PROGRESS IN THE
ELIMINATING HEALTH INIQUITIES
AND ACHIEVING HEALTH EQUITY BY
LOOKING STRUCTURES THAT ARE
CAUSING SOCIALLY AND
ECONOMICALLY DISPLACED
POPULATIONS BECOME SICK IN THE
FIRST PLACE.
IT HAS 2 GOALS, FIRST IT WILL
FACILITATE AND IMPLEMENT
FRAMEWORK ACROSS NIH PER HEALTH
EQUITY INTERVENTION RESEARCH.
SECOND IT WILL DEPLOY AND
EVALUATE COMMUNITY DRIVEN
STRUCTURAL HEALTH EQUITY
INTERVENTIONS THAT LEVERAGE
INTERSECTORRAL PARTNERSHIPS.
SO MORE ON THIS PROGRAM WILL BE
AVAILABLE IN THE COMING WEEKS.
ADDITIONALLY NINR IS HELPING TO
LEAD THE TRANSFORMATIVE RESEARCH
TO ADDRESS HEALTH DISPARITIES
AND ADVANCE HEALTH EQUITY COMMON
FUND PROGRAM.
THIS IS SUPPORTING INNOVATIVE
TRANSLATIONAL RESEARCH PROJECTS
TO PREVENT, REDUCE OR ELIMINATE
HEALTH DISPARITIES AND ADVANCE
HEALTH EQUITY.
THIS INITIATIVE GREW OUT OF THE
UNITE INITIATIVE AND
SPECIFICALLY COMMITTEE END.
WE ARE VERY GLAD TO HAVE THE
EXPERTISE OF NICHD'S JUANITA
CHIN WHO IS SERVING ON THE
WORKING GROUP FOR THIS PROGRAM.
IN ADDITION NINR IS
PARTICIPATING IN OTHER HHS WIDE
AND GOVERNMENT WIDE INITIATIVES.
THESE INCLUDE THE HHS SOCIAL
DETERMINANTS OF HEALTH WORK
GROUP, THE HHS INITIATIVE TO
STRENGTHEN PRIMARY HEALTHCARE
THE INNER DEPARTMENTMENTAL
EQUITY COLLABORATIVE.
THE SOCIAL DETERMINANTS OF
HEALTH INTERAGENCY POLICY
COMMITTEE AND THE INNER AGENCY
WORKING GROUP FOR THE NATIONAL
HEALTHCARE QUALITY AND
DISPARITIES REPORT.
SO WE ARE VERY GLAD TO BE
PARTICIPATING IN THESE
INITIATIVES WITH OUR COLLEAGUES
ACROSS NIH AND ACROSS THE
FEDERAL GOVERNMENT.
AND I AM EXCITED TO EXPLORE HOW
WE CAN FOSTER EVEN MORE
COLLABORATIONS BETWEEN NINR AND
NICHD BECAUSE, AS YOU PROBABLY
SAW, WE SHARE MANY INTERESTS, IN
FACT, WE'RE ALREADY BEGINNING TO
BUILD THOSE COLLABORATIONS.
FOR INSTANCE, NINR IS
PARTICIPATING IN THE NIH
MATERNAL MORBIDITY AND MORTALITY
TASK FORCE ADVISORY CABINET
WHICH IS LED AS YOU KNOW BY
NICHD, AS WELL AS BY THE NIH
OFFICE OF THE DIRECTOR AND THE
OFFICE OF RESEARCH ON WOMEN'S
HEALTH.
WE ARE PROUD TO SUPPORT THE
APPROVE INITIATIVE.
RESEARCHERS WE'VE SUPPORTED
THROUGH APPROVE ADMINISTRATIVE
SUPPLEMENTS INCLUDE
[INDISCERNIBLE] WHO IS EXPLORING
RELATIONSHIPS BETWEEN
PSYCHOSOCIAL STRESSORS SUCH AS
ACES AND NEIGHBORHOOD
DEPRIVATION AND FUNCTIONAL
IMMUNE PROFILES BETWEEN 20 AND
26 WEEKS GUESTATION IN BLACK
WOMEN.
WE ARE ALSO SUPPORTING DR. LE AN
REDMAN TO EXAMINE THE EFFECTS OF
COVID-19 PANDEMIC ON PERIINATE
ILLEGALS FISCAL AND MENTAL HEGHT
OUTCOMES AND WE ARE SO DPLAD
THAT NICHD AND NIMHD ARE
SUPPORTING NURSE SCIENTISTS
INCLUDING DR. JAN
[INDISCERNIBLE] AND DR. CARMEN
[INDISCERNIBLE] WITH IMPROVE
ADMINISTRATIVE SUPPLEMENTS SO WE
CERTAINLY LOOK FORWARD TO
EXPANDING OUR SUPPORT OF
IMPROVED RESEARCH AND TOWARDS
THAT GOAL, WE RECENTLY SIGNED ON
TO A NOSI.
AS YOU PROBABLY HAVE HEARD, THE
GOAL IS TO SUPPORT THE
DEVELOPMENT AND IMPLEMENTATION
OF STRATEGIES TO INFORM
INTEGRATED--INTEGRATED EFFORTS
INVOLVING POLICY AND PRACTICE
CHANGES TO IMPROVE CONCEPTION,
PREGNANCY, PERINATAL AND
POSTPARTUM CARE AND ADVANCE
MATERNAL HEALTH AND MATERNAL
HEALTH EQUITY.
NOW BEYOND IMPROVE, WE SUPPORT
RESEARCH TO ADVANCE MATERNAL
HEALTH AND EQUITY.
THIS INCLUDES RESEARCH BY
DR. CARMICHAEL THAT FOCUSES
UNDERSTANDING FACTORS THAT
UNDERLIE RACIAL AND ETHNIC
DISPARITIES IN SEVERE MATERNAL
MORBIDITY WITH A PARTICULAR
FOCUS ON A WIDE RANGE OF SOCIAL
DETERMINANTS OF HEALTH AND NINR
SHARES NICHD'S COMMITMENT TO
RESEARCH THAT WILL IMPROVE THE
HEALTH OF CHILDREN AND REDUCE
DISPARITIES.
THIS INCLUDES RESEARCH ON A WIDE
VARIETY OF TOPICS, INCLUDING
DIET, CHILD FEEDING, BREAST
FEEDING, PHYSICAL ACTIVITY AND
SLEEP.
OBESITY AND ASMA, AND
VACCINATION AND HIV PREVENTION
TO NAME JUST A FEW.
NOW MANY OF THESE STUDIES ARE
CONDUCTED WITH HEALTH DISPARITY
POPULATIONS AND MANY ALSO
ADDRESS SOCIAL AND STRUCTURAL
FACTORS SUCH AS TRAUMA AND
HOUSING.
SO I WANT TO ALSO THANK NICHD
FOR ITS PARTICIPATION IN A
RECENT NINR LED RFA TO ADVANCE
THE DEVELOPMENT IMPLEMENTATION
AND EVALUATION OF INTEGRATIVE
MODELS OF SUPPORTIVE CARE TO
IMPROVE MATERNAL HEALTH OUTCOMES
AMONG PERSONS OF COLOR.
MORE OVER OUR INSTITUTE SHARE A
NUMBER OF VALUES, ON WHICH I
BELIEVE WE CAN BUILD
PARTNERSHIPS TOWARDS COMMON
GOALS.
SO LIKE NINR, NICHD HAS
COMMITMENT TO PROMOTING
INCLUSIVE SCIENTIFIC WORKFORCE.
NINR'S COUNCIL RECENTLY EMPLOYED
2 GROUPS THAT ARE ADDRESSING
DIVERSITY AND INCLUSION IN OUR
RESEARCH WORKFORCE AND IN THE
SCIENCE WE SUPPORT.
SO I AM LOOKING FORWARD TO
LEARNING FROM THOSE WORKING
GROUPs A THAT IS EXAMINE THESE
ISSUES AND I ENCOURAGE LIKE
MINDED INSTITUTES LIKE NICHD AND
NINR TO SHARE BEST PRACTICES AND
LESSONS LEARNED ON THESE ISSUES.
SIMILARLY, NINR AND NICHD, SHARE
COMMITMENTS TO HEALTH EQUITY AND
DISEASE PREVENTION.
AND AS I MENTIONED EARLIER, AS
THE LARGEST SEGMENT OF THE
HEALTHCARE WORKFORCE, NURSES ARE
EVERYWHERE, INCLUDING AND
DELIVERY ROOMS, PEDIATRICIAN
OFFICES AND SCHOOLS.
AND NURSES ARE THE MOST TRUSTED
HEALTHCARE PROVIDERS, WHO PLAY
IMPORTANT ROLES IN EDUCATING
PARENTS, GUARDIANS AND YOUNG
PEOPLE ON HOW TO ACHIEVE THEIR
HEALTHIEST LIVES.
SO I WOULD LIKE FOR TODAY'S
PRESENTATION TO BE JUST THE
DEBINNING OF NEW COLLABORATION
BETWEEN US AND I WOULD LOAF TO
HEAR YOUR THOUGHTS ON HOW WE CAN
FOSTER THE
DEVELOPMENT--DEVELOPMENT OF
INNER DISCIPLINARY TEAMS ACROSS
OUR INNSITUTES AND IN OUR FUNDED
RESEARCH.
AND WHAT ARE BOLD INITIATIVES
THAT NINR AND NICHD CAN PARTNER
ON TO IMPROVE HELT AND WELL
BEING ESPECIALLY FOR POPULATIONS
WHO EXPERIENCE HEALTH
DISPARITIES.
SO THANK YOU AGAIN FOR INVITING
ME TO TALK WITH YOU TODAY, I
LOOK FORWARD TO YOUR QUESTIONS,
WITH OUR REMAINING TIME AND WE
PROVIDED OUR E-MAIL ADDRESS HERE
SO IF THERE'S ANYTHING WE DON'T
GET A CHANCE TO TALK ABOUT
TODAY, ANY PROGRAM YOU WOULD
LIKE MORE INFORMATION ON, PLEASE
FEEL FREE TO REACH OUT TO US AND
WE WILL GET THE INFORMATION YOU
NEED.
SO THANK YOU VERY MUCH.
>> THANK YOU SO MUCH SHANNOR
THAT WAS AN AMAZING OVERVIEW
THAT INCLUDED--EVERYTHING THAT
WE WANTED YOU TO AND I JUST WANT
WHAT IS A TRICK QUESTION BECAUSE
NINR IS 1 OF THE SMALLER
INSTITUTES, I DON'T KNOW WHAT
YOU'RE NOTAL ANNUAL BUDGET IS,
APPROXIMATELY, BUT I ALWAYS ASK
PEOPLE, WELL, WE ARE CLEARLY THE
NUMBER 1 INSTITUTE WHEN WE TALK
ABOUT PERCENTAGE OF THE BUDGET
DEVOTED TO SEVERE MATERNAL
MORBIDITY AND MORTALITY AMONGST
MATERNAL HEALTH ISSUES AND
THAT'S ABOUT JUST UNDER 5% OF
OUR BUDGET BUT NUMBER 2, IS
NINR, WHICH IS SURPRISING,
ALMOST NOBODY GETS THE ANSWER TO
THAT QUESTION.
SO ALMOST 3 PERCENT OF YOUR
BUDGET IS DEVOTED WITH REGARD TO
MATERNAL HEALTH AS YOU SO
ELOQUENTLY PUT IT.
SO, SO WE'RE VERY EXCITED ABOUT
ENHANCING OUR COLLABORATIONS AND
IT LOOKS LIKE HAVE YOU A
QUESTION FROM DR. SHARI, BARKIN.
>> GREAT.
>> THANK YOU SO MUCH.
WHAT A TOUR DEFORCE, THAT'S
REALLY EXCITING.
I AM DIVISION CHIEF OF GENERAL
PEDIATRICS AT VANDERBILT,
SEVERAL OF MY MENTEES ARE NURSES
AND WE DO A LOT OF COLLABORATIVE
WORK, WE ALSO WORK IN THE
COMMUNITY ADDRESSING HEALTH
EQUITY AND SOCIAL DETERMINANTS
OF HEALTH AND I JUST THINK YOU
REALLY CREATED SUCH AN
INTEGRATED VISION.
HERE'S MY QUESTION TO YOU, SO
MUCH OF THE UNDERLYING
CONTRIBUTORS WHEN WE LOOK AT
SOCIAL DETERMINANTS OF HEALTH
LIVE OUTSIDE OF HEALTH AS YOU
IDENTIFIED AND IT LIVES IN
HOUSING, IT LIVES IN EMPLOYMENT,
CHILDCARE, FOOD SYSTEMS, ET
CETERA, TO DO THIS TYPE OF
TRANSDISCIPLINARY WORK, WE NEED
TO THINK ABOUT FUNDING
MECHANISMS THAT ARE STRUCTURED
IN DIFFERENT WAYS.
I WOULD JUST LIKE TO HEAR WHAT
HAVE YOU BEEN ABLE TO IDENTIFY
TO MOVE US FORWARD TO IMPLEMENT
THIS TYPE OF WORK WITH HIGH
QUALITY.
THANK YOU.
>> THANK YOU.
I COULDN'T AGREE MORE.
YOU KNOW NICHD AND NINR IS IN A
POSITION WHERE WE DO SEE ACROSS
A WIDE VARIETY OF DISEASES AND
CONDITIONS AND I THINK WE'RE
VERY WELL POSITIONED TO ADDRESS
THESE MORE UPSTREAM FACTORS AND
I AGREE WE DO NEED MORE
CREATIVITY AND WE NEED TO HEAR
FROM OUR RESEARCH COMMUNITIES
ABOUT WHAT'S NEEDED TO ADVANCE
THIS TYPE OF RESEARCH.
WHAT ARE THE LIMITATIONS OF OUR
CURRENT FUNDING MECHANISMS AND
THE WAY WE GO ABOUT BUSINESS AT
THE NIH TO BE MORE EFFECTIVE.
I MOON I WOULD SAY THAT THE
COMPASS PROGRAM REPRESENTS A
STEP FORWARD FOR US AT NIH
THINKING ABOUT LOOKING UPSTREAM
AT FACTORS, DEDICATING RESOURCES
TO THAT, THINKING ABOUT
COMMUNITY DRIVEN RESEARCH,
REALLY ADDRESSING WHAT ISSUES
THE COMMUNITY THINKS IS
IMPORTANT AS WELL AS HELPING TO
FACILITATE THEM TO BE IN THE
DRIVER SEAT OF THAT RESEARCH.
SO, NOT EVEN JUST PARTNERSHIPS
OR COLLABORATION, BUT REALLY
COMMUNITY DRIVEN RESEARCH IN
EVERY SENSE OF THE WORD.
AND SO WE'RE EXCITED ABOUT
COMPASS AND WHAT IT CAN DO TO
ADVANCE THIS TYPE OF RESEARCH
ACROSS THE NIH, PROVIDING A
MODEL INTO THE FUTURE WHICH IS A
GOAL OF THESE COMMON FUND
PROGRAMS.
>> ALAN DO YOU HAVE A QUESTION,
YOU CAME ON VIDEO.
>> DR. ZENK, THANK YOU SO MUCH,
AMAZING.
I AM ALAN TITA I'M BASED HERE AT
UAB, ALABAMA WHICH IS LOTS OF AT
STAKE WITH EQUITY AND SOCIAL
DETERMINANTS OF HEALTH SO IT'S
TERRIFIC TO SEE AND LOOK AT THE
LENGTHS THAT YOU DESCRIBED.
JUST 2 QUICK QUESTIONS RELATED:
ONE IS, AFTER SEEING THE
TERRIFIC WORK OROUND WOMEN,
MATERNAL MORTALITY, ET CETERA, I
SAN FRANCISCO THAT THE BUDGET OF
WHAT YOU COVER 20% WOMEN'S
HEALTH THAT SEEMED A BIT LOW TO
ME SO IS IT 80%?
WOULD YOU JUST COMMENT ON THAT
AND THEN THE OTHER QUESTION IS
AROUND GLOBAL HEALTH, THE WORK
YOU DO AROUND GLOBAL HEALTH
GIVEN JUST HOW INTERCONNECKED
THINGS ARE WITH COVID AND OTHER
PRIORITIES.
THANK YOU.
>> YES, THANK YOU.
SO THOSE PERCENTAGES, THERE ARE
UNIQUE, THEY'RE OVERLAPPING IN
TERNALS OF THE RESEARCH SUPPORT,
BUT I AGREE, I WAS A LITTLE
SURPRISED ABOUT THE NUMBER IN
TERMS OF MATERNAL HEALTH, I
THINK NINR HAS A LOT MORE WE CAN
CONTRIBUTE TO THAT SPACE, SO AS
DR. BIANCHI, POINTED OUT
RELATIVELY WE'RE DOING PRETTY
WELL COMPARED TO THE IN, IH BUT
I COULDN'T AGREE MORE THAT IT'S
SUCH AN IMPORTANT ISSUE AND NINR
AND NURSING SCIENCE HAS SO MUCH
MORE WE CAN CONTRIBUTE THERE, SO
WE OVER THE LAST COUPLE YEARS AT
THE INSTITUTE HAVE BEEN TALKING
ABOUT WHAT MORE WE CAN DO AND
THE RFA WE PUT OUT JUST THIS
SPRING THAT NICHD ALSO SIGNED ON
TO ADDRESS THESE INTEGRATIVE
MODELS OF CARE IS 1 STEP FORWARD
TO DOING MORE IN THAT SPACE, TO
MAKE AN IMPACT, AND THEN IN
TERMS OF GLOBAL HEALTH, IT'S
SOMETHING THAT I HAVE SPOKEN
WITH ROGER GLASS AT FOGARTY
ABOUT WHAT WE CAN DO TO ADVANCE
NINRSOCIAL HEALTH.
SO WE HAVE THAT GOING EXPW WE DO
MORE IN TERMS OF TRAINING AND
GROABAL HEALTH BUT AGAIN WE HAVE
BIG DREAMS AND LOTS OF THINGS WE
THINK WE CAN CONTRIBUTE TO AND
TRYING TO FIGURE OUT HOW WE CAN
COLLABORATE TO BE MORE EFFECTIVE
IN THESE IMPORTANT AREAS, IS
DEFINITELY ON OUR MIND.
>> THANK YOU SO MUCH.
>> I SEE THEREYA A QUESTION FROM
MELISSA MILLER?
>> MELISSA MILLER FROM THE
D.O.D.
JUST A QUICK QUESTION, YOU SPOKE
INCREDIBLY ELOQUENTLY ABOUT THE
IMPORTANCE OF MATERNAL HEALTH,
PEDIATRICS, I WAS JUST WONDERING
WHAT NINR IS DOING TOWARDS
DISABILITY AND DISABILITY CARE?
>> YEAH, I THINK IN OUR
STRATEGIC PLAN, ACCESSIBILITY,
IN TERMS OF RESEARCH IS A
PRIORITY FOR US AS WE MOVE
FORWARD.
I DON'T HAVE A VERY GOOD HANDLE
AND EXAMPLES RIGHT NOW OF THAT,
BUT I'M HAPPY TO PROVIDE YOU
MORE INFORMATION.
WE RECOGNIZE IT'S AN IMPORTANT
ISSUE AND APPRECIATE EVERYTHING
THAT NICHD HAS DONE IN THAT
SPACE AS WELL.
>> THANK YOU, WE'RE RIGHT ON
TIME, SHANNON THERE'S A VERY
NICE COMMENT FROM SHARI BARKIN
AND AS WELL AS KUDOS FROM OTHER
COUNCIL MEMBERS.
>> THANK YOU SO MUCH FOR HAVING
ME IT'S BEEN A PLEASURE.
>> NO, WE ARE DELIGHTED AND
WE'RE ALL INFORMED AND EXCITED
ABOUT POTENTIAL FOR FUTURE
COLLABORATION SO TAKE CARE AND
WITH THAT WE'RE BEING TO MOVE ON
TO OUR NEXT TOPIC.
WE ARE SUPPOSED TO HAVE
DR. ANDREA THURMAN WHO IS A
FUNDED NICH D.
>> I THOUGHT I WAS SUPPOSED TO
GO ON THE PUBLIC WEBBING SITE.
>> OKAY, WE HAVE THAT,.
>> SO YOU'RE ANNY OR ANDRIEA?
>> YEAH, MY REAL NAME IS ANDREA,
BUT EVERYBODY CALLS ME ANNY.
>> SO WE'RE STUDYING THE FIRST
IN WOMEN ARE, HUMAN
CONTRACEPTIVE ASPECT BODY AND
THIS PROJECT IS SUPPORTED BY OUR
CONTRACEPTION RESEARCH BRANCH
AND TO INTRODUCE DR. THURMAN, I
WILL INVITE DR. DAN JOHNSTON
CHIEF OF THE CONTRACEPTION
BRANCH TO INTRODUCE DR. THURMAN,
DAN, OVER TO YOU.
>> THANK YOU DOCTOR.
I THINK MY CAMERAS HAVE SWITCHED
UP ON MY A LITTLE BIT SO I WILL
BE DIRECTING A LITTLE BIT
DIFFERENTLY THAN EXPECTED BUT
IT'S MY PLEASURE TO INTRODUCE
DR. ANNIE, THURMAN, SHE IS
DOCTOR OF GYNECOLOGY AND
REPRODUCTIVE TECHNOLOGY AND
DIRECTOR OF RESIDENT RESEARCH AT
EVMS, BOARD CERTIFIED PRACTICING
OBGYN WITH OVER 24 YEARS OF
EXPERIENCE IN ACADEMIC MEDICINE,
EXTENSIVE EXPERIENCE IN
PRECLINICAL AND CLINICAL
RESEARCH INCLUDING PROTOCOL
DEVELOPMENT, OPERATIONS, PATIENT
CARE, PHARMA CODYNAMMICS,
SAFETY, EFFICACY AND
ACCESSIBILITY.
SHE'S BEEN THE LOCAL SIDE
PRINCIPLE INVESTIGATOR AND
INVESTIGATOR IN OVER 250
CLINICAL TRIALS ON WOMEN'S
HEALTH PRODUCTS INCLUDING
CONTRACEPTIVES, MENOPAUSAL
PRODUCTS, VAGINAL HEGHT
PRODUCTS, HIV AND HSV2, AND
MULTIPREVENTION TECHNOLOGY,
TODAY SHE WILL BE PRESENTING A
VERY BEING PROGRAM SUPPORTED BY
THE KOBT RASEPTORS OF RESEARCH
BRANCH TERNALLED HUMAN
CONTRACEPTIVE ANTIBODY OR HCA,
OR THANK YOU FOR TAKING THE TIME
TO SHARE YOUR RESEARCH TODAY.
>> THANK YOU DR. JOHNSTON, I
HAVE MY SLIDES OR I KNOW I SENT
THEM.
I CAN PULL THEM UP IF THAT WORKS
THE BEST I'LL SHARE MY SCREEN
HERE.
OKAY.
CAN YOU SEE MY SCREEN?
YOU HAVE TO GO TO DISPLAY
SETTINGS AND FLIP IT AROUND UP
THE TOP.
>> DISPLAY SETTINGS, HOW'S THAT.
>> YEP.
>> AWESOME.
THANK YOU.
WOOR HAVING A THUNDERSTORM HERE
SO MY INTERNET WENT OUT AND MY
HUSBAND'S VAN HAS A WIFI HOT
SPOT AND FORTUNATELY I'MING
COMING TO YOU FROM MY HOUSE AND
NOT THE VAN.
SO I'M AT EAST VIRGINIA MEDICAL
SCHOOL.
WE WERE A SUBAWARDEE OF
DR. DEBORAH ABDOMENNERSON FROM
BOSTON UNIVERSITY.
HER P50 AWARD AND WE CONDUCTED
THIS STUDY, ALSO WITH THE
EXPERTISE FROM ZAB BIOWHO DID A
LOT OF FILM DEVELOPMENT AND THE
HUMAN CONTRACEPTIVE ANTIBODY
DEVELOPMENT.
MEMBERS OF BOSTON UNIVERSITY AND
ZAB BIOARE ON THE CALL BUT I
BELIEVE THEY ARE ON THE PUBLIC
LINE, SO I WILL SEND THEM THE
ZOOM LINE AFTER I FINISH HERE.
SORRY ABOUT THE CONFUSION.
O OUR HUMAN CONTRACEPTIVE ASPECT
BODY IS A NONHORR MOINAL
CONTRACEPTION OPTION FOR WOMEN
AND WHAT ARE THE CURRENT
NONHORMONAL CONTRACEPTIVES THAT
ARE AVAILABLE.
ALL OF THEM HAVE DISTINCTFI
BENEND RISK, THE COPPER
IUD, THE BENEFIT IS THAT IT HAS
AN EXTREMELY LOW FAILURE RATE,
IT IS FDA APPROVED FOR 10 YEARS,
IT PROBABLY LASTS FOR 20 YEARS,
THE MOST COST EFFECTIVE
CONTRACEPTIVE AROUND AND
COMPLETELY REVERSIBLE.
SOME OF THE DISADVANT ANNUALS OF
THE COPPER IUD ARE THAT IT CAN
CAUSE SOME HEAVIER PERIODS AND
PAINFUL PERIODS.
IT REALLY DOESN'T HAVE ANY
NONCONTRACEPTIVE BENEFITS LIKE
SOME OF THE HORMONAL
CONTRACEPTIVES, I THINK THE
BIGGEST BENEFIT IS THAT IS A
HIGHLY EFFECTIVE REVERSIBLE
NONHORMONA DEVICE.
THERE ARE ALSO BARRIER DEVICES
SUCH AS CONDOMS, MALE AND FEMALE
CONDOMS, DIAPHRAGMS, HERE WE SEE
THE SILK DIAPHRAGM OR THE KIA
DIAPHRAGM WHICH WAS DEVELOPED BY
CONRAD AND PATH.
THE PRO OF THE DEVICES IS THAT
THEY'RE ON DEMAND, MANY WOMEN
DON'T WANT TO BE ON
CONTRACEPTION ALL THE TIME, THEY
JUST WANT TO USE IT WHEN THEY'RE
AT RISK, IT'S NONHORMONAL AND
MANY OF THE BARRIER DEVICES,
PROTECT A WOMAN NOT ONLY AGAINST
PREGNANCY BUT SEXUALLY
TRANSMITTED INFECTIONS MAKING
THEM MULTIPURPOSE PREVENTION
TECHNOLOGIES OR MPTs.
THE DOWN SIDE OF BARRIER DEVICES
ARE THAT THEY'RE NOT ALL WOMEN
CONTROLLED AND SOME MEN ARE SOME
COUPLES FIND THEM UNACCEPTABLE.
THERE'S ALSO A NONHORMONAL
OPTION WHICH IS A TUBAL
LIGATION.
THE PARTICIPANT THAT WE'RE GOING
TO INTERVIEW TODAY HAD A
PROCEDURE CALLED AN ESURE
PROCEDURE, HE GO IN EFTHIMIOS
ROUGH ATOM SCOPICALLY IN THE
OFFICE AND PLACE THESE NICKEL
SPRINGS IN THE OPENING OF THE
FALLOPIAN TUBE AND THESE SCAR
OVER FOR 3 MONTHS THEY'RE NOT
REVERSIBLE BUT WE DO A EFTHIMIOS
ROUGH ATOM PING O GRAP AFTER THE
PROCEDURE TO MAKE SURE THAT THE
TUBES ARE BLOCKED SO A LOT OF
WOMEN LIKE THAT.
THIS PROCEDURE IS NO LONGER
AVAILABLE IN THE U.S., IT IS
AVAILABLE IN OTHER COUNTRIES BUT
THIS IS NO LONGER AN OPTION FOR
TUBAL STERILIZATION FOR U.S.
WOMEN.
SO FOR U.S. WOMEN IF YOU WANT
YOUR TUBES TIED YOU HAVE TO HAVE
IT DONE AT THE TIME OF C-SECTION
OR LAPROSCOPICLY AND THE REASON
I PUT THIS PICTURE UP HERE IS
BECAUSE WHEN WE USED TO TIE
TUBES, WE HAD 2 PORTS, WE HAD A
CAMERA, AND THEN WE HAD A PORT
TO EITHER PLACE THE CLIPS OR THE
BURN THE TUBES OR WHATEVER, NOW,
MANY CENTERS ACROSS THE U.S. ARE
NOT ONLY TYING THE TUBES THEY'RE
REMOVING BOTH TUBES, SO THIS
ADDS A PORT, IT ADDS SURGICAL
TIME.
IT'S SYRUPLY NOT REVERSIBLE IF
YOUR TUBES HAVE BEEN REMOVED,
THE REASON THAT PEOPLE ARE DOING
BILATERAL SELF-INJECT MES NOW IS
THAT THERE'S SOME THOUGHT THAT
SOME OVARIAN CANCER MIGHT BE
FALOPENNIAN TUBE CANCER,
ALTHOUGH IT'S NOT BEEN PROVEN IT
IT'S THOUGHT THIS MAY BE A
CANCER PREVENTION OPTION FOR
WOMEN WHO WANT STERILEAISE IEGZ.
LASTLY THERE ARE THE NONHORMONAL
SPERMAICIDES THEY HAVE THE
DISTINCT ADVANTAGES OF BEING AN
ON-DEMAND PRODUCT AND OVER THE
COUNTER AND REVERSIBLE.
HOWEVER, THE BIGGEST DOWN SIDE
OF THE SPERMICIDES PARTICULARLY
NONXYL 9 SDHS IS AVAILABLE IN
THE UNITED STATES, IT CAN CAUSE
VAGINAL IRRITATION,
SUBCLINICALLY, ALTERATIONS OF
THE MICROBIOME WHICH ENHANCE HIV
ACQUISITION RISK AND THIS IS WHY
NONE ACCIDENT ILLEGALS 9 CANNOT
BE RECOMMENDED FOR USE IN
REGIONS THAT HAVE HIGH HIV
INCIDENCE AND PREVALENCE.
SOEUR GROUP WAS INTERESTED IN
IMMUNO CONTRACEPT, THIS IS USING
ACTIVE IMMUNIZATION LIKE
VACCINES OR PASSIVE IMMUNIZATION
WHICH IS WHAT WE DEVELOPED HERE,
OR THE TRANSFER OF ANTIBODIES WE
DEVELOPED A HUMAN CONTRACEPTIVE
ANTIBODY, IT WAS ACTUALLY
DEVELOPED FROM THE SERUM OF AN
INFERTILITY PATIENT.
IT IS THOUGHT THAT MANY
INFERTILITY PATIENTS HAVE SOME
ANTISPERM ANTIBODIES, AND WE
USED TO ROUTINELY CHECK FOR THIS
IN INFERTILITY WORK UPS, SO ZAB
BIODEVELOPPED AN IGG HUMAN
ANTIBODY IT'S CALLED HC4 IS THE
DRUG SUBSTANCE, THEY GROW THIS
ANTIBODY IN NICOTINE PLABTS IN A
GMP FARM/LAB AND THEN THEY
INCORPORATED THIS DRUG SUBSTANCE
INTO THEIR DRUG PRODUCT WHICH IS
A VAGINAL FILM CALLED THE ZB-06
FILM AND HERE I HAVE THE
COMPONENTS OF THE VAGINAL FILM.
JUFULT A LITTLE BIT MORE ABOUT
THE ZB-06 FILM DEVELOPMENT THE
TARGET OF THE HUMAN
CONTRACEPTIVE ANTIBODY PRODUCT
IS ACTUALLY CD52 G, WHICH IS A
GLYCOPROTEIN THAT IS EXPRESSED
EXCLUSIVELY IN THE HUMAN MALE
REPRODUCTIVE TRACT, IT'S A
COMMON TARGET FOR ANTISPERM
ANTIBODIES FROM INFERTILITY
PATIENTS.
JUST LOOKING AT A COMPARISON OF
OUR PRODUCT VERSUS SOME RECENTLY
APPROVED NONHORMONAL PRODUCT
WHICH IS CALLED [INDISCERNIBLE]
AND A RECENTLY APPROVED HORMONAL
PRODUCT CALLAD ANAVERRA, SO ZAB
BIOCONDUCTED SEVERAL OF THE
PREIND STUDIES ON THE ZB-06 FILM
FOR ANY TOPICAL VAGINAL PRODUCT,
YOU NEED A RABBIT VAGINAL
IRRITATION STUDY, THE ZB-06
PROGRAM ACTUALLY BUILT UPON A
PRECURSOR PRODUCT WHICH WAS
CALLED MB66.
IT WAS A VAGINAL FILM THAT
CONTAINED HUMAN MONOCLONAL
ANTIBODIES AGAINST BOTH HIV AND
HERPES SIMPLEX VIRUS 2.
THESE ANTIBODIES WERE ALSO
AMPLIFIED IN THE TOBACCO PLANT
PLATFORM.
DR. ANDERSON AT BOSTON
UNIVERSITY AND ZAB BIO ALONG
WITH COLLEAGUES AT BROWN
UNIVERSITY CONDUCTED A PHASE 1
SINGLE AND REPEAT DOSE STUDY OF
MB66 AND PUBLISHED THEIR
FINDINGS.
SO BUILDING OFF OF THE MB66
PRODUCT.
ZAB FILED AN EXPLORATORY IND IN
DECEMBER OF 2020 AND UNDER THIS
EXPLORATORY IND, WE WERE ABLE TO
PROCEED WITH OUR FIRST IN WOMAN
STUDY OF ZB-06 FILM.
SO A LITTLE BIT ABOUT
CONTRACEPTIVE EFFICACY
DEVELOPMENT, I MEAN, THE
ULTIMATE BIOMARKER OF
CONTRACEPTIVE EFFICACY IS
OBVIOUSLY PREGNANCY, BUT, WE
DON'T WANT TO TAKE THIS UNTESTED
PRODUCT AND GIVE TO FETTERILE
WOMEN AND SAY TRUST US THIS WILL
WORK.
BUT SO FOR HORMONA
CONTRACEPTIVES WE HAVE SOME
PRETTY ESTABLISHED CONTRACEPTIVE
SURROGATES LIKE LOOKING AT
ANOVULATION SERUM PROGESTERONE
OR FOLLICULAR DEVELOPMENT ON
TRANSVAGINAL ULTRASOUND.
FOR THE BARRIER CONTRACEPTIVES,
THERE IS SOME BIOMARKERS OF
RECENT AND LONGER DURATION SEMEN
EXPOSURE SO THAT WE CAN SEE IF
CONDOMS ARE BREAKING OR SLIPPING
BUT FOR THE POST KOITAL TEST,
FOR PRODUCTS THAT WOULD DEPEND
ON THAT TESTING, SUCH AS THE
HUMAN CONTRACEPTIVE ANTIBODY,
THE POST KOITAL TEST WAS ORIGE
NAWILLLY A TEST TO ELECTRIC AT
FERTILITY AND CERVICAL FACTOR
FERIT AND IT'S BEEN USED FOR
DECADES BUT IT'S AN ELEGANT
FUNCTIONAL IN VIVO PHARMA CO
DYNAMICS SURROGATE OF CERVICAL
MUCUS AND SPERM INTERACTION BOTH
WITH AND WITHOUT THE
CONTRACEPTIVE PRODUCT.
AND SO THIS IS THE TYPE OF STUDY
THAT WE DID FOR THE HUMAN
CONTRACEPTIVE ANTIBODY FILM.
JUST TO GIVE YOU A LITTLE
BACKGROUNDOT MENSTRUAL CYCLE.
PARTICIPANTS IN THIS STUDY ARE
OBLIGATIONSULATORY AND ARE NOT
ON EXOGENOUS HEAR MOANS WE HAVE
THEM CHECK THEIR URINE FOR A
LIEWTINNIZING HORMONE SURGE AND
WE KNOW WHEN THE LIEWTINNIZING
HORMONE SURGES WE ENTER ABOUT A
12-36 HOUR WINDOW AROUND
OVULATION, AFULATION WILL OCCUR
SHORT LYE AFTER THIS AND YOU
WILL NOTICE THAT AFTER THE TIME
OF THE HORMONE SURGE THIS IS
WHEN ESTROGEN LEVELS PEEK AND
ESTROGEN LESMS INCREASES CAUSE
FOLLICULAR DEVELOP EXPMENT THEY
ALSO CAUSED CERVICAL MUCUS TO BE
IDEAL FOR THE ASCENT OF MODAL
SPERM.
THE CERVICAL MUCUS IS WATERY,
CLEAR, AND THIN.
SORTLY AFTER OVULATION WHEN THE
CORPUS LUTEUM TAKES OVER THE
PROGESTERONE LEVELS RISE AND
THIS IS WHEN THE CERVICAL MUCUS
BECOMES CHICKENED, INFLAMED AND
ACTUALLY DOES NOT ALLOW
PROGRESSIVELY MODAL SPERM TO
ASCEND INTO THE UTERROUS.
SO WE'RE REALLY TESTING A
CONTRACEPTIVE PRODUCT AT MAXIMUM
PEAK FERTILITY TO LOOK AT ITS
PERFORMANCE.
OKAY, SO WHO ARE WE TESTING THIS
PRODUCT ON.
THESE ARE HEALTHY WOMEN, AGING
18-50.
PREMENOPAUSAL WOMEN, THEY HAVE
TO BE OBLIGATIONS LATTERY SO WE
CAN HAVE THEM HAVE TIMED
INTERCOURSE AT OFULATION, THEY
ALL TO HAVE TO TUBAL
STERILIZATION BECAUSE WE DON'T
WANT THEM TO GET PREGNANT AND WE
DON'T ULTIMATELY KNOW HOW
EFFECTIVE OUR CONTRACEPTIVE
PRODUCT WILL BE, THEY CAN'T BE
ON EXOGENOUS HORMONES BUZZ THAT
WOULD MAKE THEIR CERVICAL MUCUS
HOSTILE TO MODAL SPERM.
SO NOT ONLY DO THESE HAVE TO BE
HEALTHY WOMEN WITH TUNAL
LIGATIONS ABOUT YOU THEY HAVE TO
BE HETEROSEXUALLY ACTIVE AND
THEIR MALE PARTNER HAS TO HAVE
NO HISTORY OF INFERTILITY.
NO VASECTOMY.
SO REALLY SINCE THE BOTH THE
FEMALE PARTICIPANT AND THE MALE
PARTNER ARE INVOLVED WE CONSENT
BOTH INDIVIDUALS.
I WANT TO GIVE YOU A BRIEF
OVERVIEW OF WHRA A PC T LOOKS
LIKE, WE SCREEN FOR EXCLUESARY
FACTORS, WE ENROLL THEM AT VISIT
2 AND WE DO A LOT OF COUNSELING
ABOUT HOW TO USE THE FILM AND
HOW TO CHECK THE URINARY LH.
A PC T CYCLE IS BASICALLY 2
VISITS, THERE'S A CERVICAL MUCUS
CHECK VISIT, THIS OCCURS ON THE
DAY OR THE DAY AFTER THE
LIEUTENNIZING HORMONE SURGE AND
WE'RE BASICALLY MAKING SURE AT
THE CERVICAL MUCUS CHECK THAT
THE CERVICAL MUCUS HAS IDEAL
PHYSICALLA CHARACTERRIVE
CLINICAL COMMUNITYS, ONCE IT
DOES, AND I'LL EXPLAIN HOW WE
EVALUATE THAT, IF THERE ARE
IDEAL CERVICAL MUCUS
CHARACTERISTICS AND THERE IS NO
SPERM PRESENT, THEN WE HAVE THE
COUPLE GO HOME AND HAVE
INTERCOURSE WITHIN ABOUT 24
HOURS OF THIS CERVICAL MUCUS
CHECK BECAUSE THE WINDOW OF THAT
OVULATION WILL CLOSE SO ONCE
THEY HAVE TIMED ISHT COURSE AT
PEEK OVULATION, WE HAVE THEM
COME INTO THE CLINIC 2-3 HEURS
AFTER TIMED IRPT COURSE BECAUSE
ACCORDING TO THE W. H. O. MANUEL
WHICH IS WHRA WE FOLLOW, 2-3
HOURS AFTER TIMED UNPROTECTED
INTERCOURSE IS WHEN YOU WILL SEE
THE MAX NUM NUMBER OF
PROGRESSIVELY MODAL SPERM
ASCENDING IN THAT OOH DEAL
OVULATTORY MUCUS SO AT BASE LINE
WITH NO PRODUCT PRESCRIBINGENT,
THE CURRENT BENCHING MARK IS
THAT THERE SHOULD BE AT LEAST 5
PROGRESSIVELY MODAL SPERNL
PERHIPOWER FIELD MEASURED AT 400
TIMES AND AVERAGED OVER 9 HIGH
POWERED FIELDS.
CONVERSELY, WE DO THE SAME
PROCEDURES, CERVICAL MUCUS
CHECKED AND TIMED INTERCOURSE AT
OVULATION, WITH THE PRODUCT
PRESENT AND THE CURRENT
BENCHMARK FROM THE W. H. O. IS
THAT THERE IS LESS THAN 5
PROGRESSIVELY MOTAL SPERM PER
HIGH POWERED FIELD AVERAGED OVER
9 HIGH POWERED FIELDS.
AS AN INVESTIGATOR THIS A POINT
OF STUDY THR THESE TESTS SO WE
WILL NO RIGHT AWAY WHETHER THE
PURPOSE HAS A PRODUCT BASE LINE
OR IS WORKING OR HAS A NORMAL
BENCHMARK, SO, LIKE I SAID AT
THE CERVICAL MUCUS CHECK, WE
WANT TO MAKE SURE THAT THE
CERVICAL MUCUS IS IDEAL.
HOW DO WE DO THAT?
WE USE WHAT'S CALLED THE INSULAR
SCORE, THAT LOOKS AT 5 FISCAL
CHARACTERISTICS OF MUCUS AND
GRADES THEM ON A SCALE OF 0-3 SO
THE MAXIMUM SCORE CAN YOU GET IS
15, MIN NUM IS ANSWER, GOOD
CERVICAL MUCUS HAS A SCORE OF 10
OR HIGHER.
SO 1 OF THE THINGS WE DO IS
CALLED THE SPINNBARKEIT, AND I
WILL PLAY A SHORT VIDEO.
SO WE'RE MEASURING THE
CENTIMETERS OF STRESS AND THAT
IS HOW WE GRADE IT.
AND WE HAVE A LOT OF PEOPLE THAT
WORKED LIKE MYSELF AT MCDONALDS
IN THE 80S SO WE HAVE A
HAMBURGLA RULER AND I THINK A
LOT OF PEOPLE HAVE SEEN THIS,
YOU KNOW WEEM CAN TELL IF
THEY'RE OVULEATORY BASED ON
CHARACTERISTICS OF MUCUS BUT
THIS IS A STANDARDIZED WAY OF
LOOKING AT IT.
WE LOOK AT THE VISCOSITY, WE
LOOK AT THE VOLUME, WE LOOK AT
FERNING ONCE SOME CERVICAL MUCUS
IS DRIED ON A SLIDE AT
OVULATION, THE CERVICAL MUCUS
HAS SOME BEAUTIFUL FERNING
PATTERN THAT WE GRADE WITH
PRIMARY, SECONDARY, TERTIARY AND
CORTINARY FERNING A LOT OF TIMES
WE WILL LOOK AT THIS FOR THE
PATIENT TOO, WE ALSO LOOK AT THE
AMOUNT OF CELLULARITY.
AT OVULATION THERE'S FEW TO MOW
CELLS, NO INFLAMMATORY CELLS,
THIS IS ACTUALLY QUITE ABUNDANT
CELLULARITY AFTER THE INFLUENCE
OF ENDOGENOUS PROGESTERONE SO
THIS A NONIDEAL SITUATION, SO
ONCE THE PATIENT, WE HAVE
ESTABLISHED THAT SHE HAS
CERVICAL MUCUS AND SHE HAS
UNPROTECTED ISHT COURSE WHEN SHE
COMES BACK IN FOR THE POIOF THE
KOITAL VISIT WE HAVE TO
REEVALUATE THE MUCUS AGAIN
BECAUSE IT HAS TO STAY IDEAL, IF
WE MISSED THAT WINDOW AND HER
CERVICAL MUCUS IS STARTING TO
THICKEN UP, THEN THAT'S REALLY
MAUL AMOUNT OF CERVICAL MUCUS ON
A GRIDDED SLIDE, WE ACTUALLY PUT
THIS MIXTURE OF VASE DEAN AND
GLASS BEADS AT EACH OF THE COVER
SLIP CORNERS SO THAT WE HAVE A
STANDARDIZED VOLUME THAT WE'RE
LOOKING AT AND WE COUNSELED
PROGRESSIVELY MOTAL SPERM,
IMMOBILE TERM AND TOTAL SPERM IN
EACH OF THESE 9 QUADRANTS AND
TAKE THE AVERAGE, OKAY, IN THIS
STUDY, WE WERE BLINDED TO THE
CYCLE TO THE INVESTIGATORS AND
COORDINATORS THAT WERE SEEING
THE PATIENT AND WE HAD PEOPLE
AVAILABLE ON THE WEEKEND TO DO
THAT.
THIS IS JUST A PICTURE OF SOME
SPERM UNDER THE MICROSCOPE, WE
LET OUR PARTICIPANTS SEE THIS
AND THEY HAD A GOOD TIME WITH
THAT.
SO AS I MENTIONED ON POST KOIDAL
TREATMENT FOR DECADES IT WAS
RECENTLY DONE AND CAN YOU SEE
HERE ON SEVERAL BARRIER AND
PERMICIDAL PRODUCTS AND PRODUCTS
THAT PERFORMED WELL IN PC T
STUDIES HAVE GONE ON TO PERFORM
AS EXPECTED WELL IF PHASE 3
EFFICACY TRIALS.
SO, THE PC T HAS REALLY BEEN
ESTABLISHED AS THE ONLY
AVAILABLE AND HIGHLY ACCURATE
CONTRACEPTIVE SURROGATE FOR
THESE BARRIER OR SPERMICIDAL
PRODUCTS.
JUST TO GIVE YOU AN IDEA OF THE
NUMBER OF PARTICIPANTS THAT ARE
COMPLETED IN THESE STUDIES, AT
MY CENTER, WE DID A STUDY ON THE
SILKS NOW KIA DIAPHRAGM, IT WAS
OVER A PERIOD OF A YEAR, WE
ENROLLED 27, 18 COUPLES WERE
DISCONTINUED AND COMMON REASONS
FOR DISCONTINUATION IS WHEN YOU
STRESS WOMEN OUT WITH A STUDY
SOMETIMES THEY'RE ANOVULE ATORY,
MORE COMMONLY WHEN YOU STRESS
COUPLES OUT, SO THAT YOU HAVE
TIMED INTERCOURSE AT 3 AMIN THE
MORNING AND THEN COME INTO THE
CLINIC AND A LOT OF TIMES
PARTNERS DON'T PERFORM AND THEN
THERE'S NOT ENOUGH SPERM AT THE
BASE LINE CYCLE, SO WE HAD 9
COUPLES WHO COMPLETED IN 1
YEAR'S TIME AT 2 CENTERS,
[INDISCERNIBLE] BIOSCIENCE
RECENTLY PUBLISHED THE RESULTS
OF THEIR COMBINED PC T AND
SAFETY STUDY.
THIS WAS MORE COMPLICATED THAN
JUST A PC T STUDY, THEY HAD 6
U.S. SITES, 5 SITES INCLUDING
OURS WERE PART OF THE NICHD
CONTRACEPTIVE TRIALS NETWORK AND
OVER A SPAN OF TBO AND HALF
YEARS 26 COUPLES WERE COMPLETED
AT 6 SITES.
SO, HOW MANY PEOPLE DO HAVE YOU
HAVE COMPLETE A PC T STUDY TO
MOVE FORWARD TO AN EFFICACY
STUDY, IT'S SURPRISINGLY NOT AS
MANY AS WHAT I WOULD THINK AND I
DON'T THINK THERE'S LIKE AN FDA
BENCHMARK.
I HAVEN'T SEEN 1 AND I'VE BEEN
INVOLVED IN A FEW PC T STUDIES.
SO OUR STUDY, THAT WE DID WITH
THE NICHD, P50 FUNDING AS A
SUBAWARDEE, WE HAD 23
SCREENINGS, ABOUT 1-2 PERMONTH
WHICH IS PRETTY NORMAL FOR OUR
SITE, WE HAD 3 SCREEN FAILS, WE
HAD 20 COUPLES THAT ENROLLED AND
LISTEN DISCONTINUED.
WE HAD 3 DISCONTINUED BECAUSE
THEY DID NOT--THE MALE PARTNER
DID NOT HAVE ENOUGH
PROGRESSIVELY MOTAL SPERM AT THE
BASE LINE CYCLE, AND THEN WE HAD
2 WOMEN WHO WERE ANOVULEATORY
BUT FOR THIS STUDY WE HAD A LOT
MORE KIND OF SOCIAL ISSUES OR
SCHEDULES ISSUES AND I THINK
THIS IS BECAUSE THE STUDY WAS
REALLY CONDUCTED IN A YEAR THAT
COVID WAS A BIG ISSUE, WE WERE
STILL ABLE TO COMPLETE 8 COUPLES
IN THE SPAN OF A YEAR.
OUR TOP LINE DATA, THE PRIMARY
END POINT IS DEMONSTRATED HERE.
WE CAN SEE IN THE NO PRODUCT
BASE LINE CYCLE, ALL 8
PARTICIPANTS HAD MORE THAN 5
PROGRESSIVELY MODAL SPERM FOR
HIGH POWERED FIELD, AVERAGED
OVER 9 HIGH POWERED FIELDS,
DURING THE USE OF THE FILM AND
WE HAD PARTICIPANTS INSERT THE
FILM ABOUT 30 MINUTES BEFORE
INTERCOURSE NO PARTICIPANT HAD
MORE THAN 5 PROGRESSIVELY MODAL
SPERM AND IN FACT, THE AVERAGE
WAS LESS THAN 1.
WE ALSO LOOKED BACK, TOM MUNCH
DID A REVIEW WHERE WE LOOK BACK
AT RECENT VAGINAL SPERMICIDE
TRIALS AND MOST OF THE TRIALS
ARE IN THE LESS THAN 1 RANGE
ALTHOUGH AGAIN THE CURRENT
BENCHMARK IS LESS THAN 5.
AND THEN IN THIS STUDY WAS
RECOMMENDED BY OUR SCIENTIFIC
ADVISORY BOARD WE HAD THE
PARTICIPANTS DO A THIRD PC T
CYCLE WITHOUT PRODUCT USE AND WE
WANTED TO MAKE SURE THAT THERE
WERE NO LINGERING ANTISPERM
ANTIBODIES, WE THOUGHT THE
POSSIBILITY OF THAT WAS VERY
REMOTE BUT WE DID DEMONSTRATE
NORMAL RETURN OF CERVICAL MUCUS
IS PROGRESSIVELY MODAL SPERM
INTERACTION AFTER PRODUCT USE.
SO SOME OF OUR SAFETY AND
ACCEPTABILITY DATA, THIS WAS A
SINGLE USE WITH 8 COUPLES BUT WE
HAD NO PRODUCT OR PROCEDURE
RELATED ADVERSE EVENTS.
WE DID HAVE 1 COUPLE THAT
NEEDED--SHE HAD INSERTED THE
FILM AND THEN THEY WERE NOT ABLE
TO HAVE INTERCOURSE SO HAD TO
FILE A PROTOCOL AMENDMENT TO
ALLOW HER TO DO A SECOND FILM
INSERTION.
WE ASSESS THE ACCEPTABILITY IN
BOTH OUR FEMALE PARTICIPANT AND
HER MALE PARTNER.
WE QUERIED THE MALE DIRECTLY
ABOUT ACCEPTABILITY AND ABOUT
ADVERSE EVENTS.
YOU KNOW ULTIMATELY, THESE ARE
NOT THE ULTIMATE END USERS OF
THIS PRODUCT.
THESE WOMEN HAVE THEIR DIEWBS
TIDE SO THESE PHASE 1 STUDIES
ARE A REALLY GOOD OPPORTUNITY TO
FIND ABSOLUTELY UNACCEPTABLE
CHARACTERISTICS THAT NO 1 WOULD
WANT AND WE CERTAINLY DID NOT
FIND ANY OF THOSE IN THIS STUDY,
SOME OF THE COUPLES HAD ISSUES
WITH THE FILM STICKING TO THEIR
FINGER, THIS IS COMMONLY KNOWN
WITH OTHER VAGINAL FILM
PRODUCTS.
SO IN CONCLUSION OUR FIRST
IN-WOMAN STUDY OF THE ZB06 EABT
BODY FILM MET THE PC T BENCHMARK
FOR EXCLUDING PROGRESSIVELY
MODAL SPERM FROM OVULE ATORY
CERVICAL MUCUS, A SINGLE DOSE
PARTICIPANT, 1 PERSON HAD 2
EXPOSURES, WAS SAFE AND WELL
TOLERATED AMONG OUR FEMALE
PARTICIPANT AND THEIR MALE
PATHWAY GIVES NETHERLANDS ANDS.
I JUST WANT TO SHOW YOU THE
TEAM, WE, YOU KNOW DO A LOT OF
SAMPLING FOR SAFETY, PK AND PC T
END POINTS.
THIS IS MY NURSE MANAGER,
RETIRED NAVY, SO WE WERE WORKING
AS A TEAM THERE.
AND WEHAVE AN ANDROLOGIST, WHO
LOOKS AT THE SPERM AND THIS IS
HER WITH HER COVID MASK AND I
WOULD ALSO LIKE TO ACKNOWLEDGE
OUR FUNDERS OF NICHD, THIS IS A
PARTICIPANT LOOKING AT HER
CERVICAL MUCUS, THE AWARD WENT
TO BOSTON UNIVERSITY, DEBORAH
ANDERSON WAS THE PI AND
ZAB BIODID THE DEVELOPMENT AND
I& D FILINGS.
I DON'T KNOW HOW YOU NORMALLY
CONDUCT THIS BUT I CAN EITHER
ANSWER QUESTIONS OR IF YOU WANT
TO HAVE THE INTERVIEW WITH OUR
PARTICIPANT.
EMPLOY >> MICKEY: WELL, FIRST
OF ALL THANK YOU ANNIE, FOR SUCH
A GREAT PRESENTATION AND THIS IS
AN AREA WE HAVEN'T HEARD A LOT
ABOUT IN THE LAST FEW COUNCIL
MEETINGS SO IT'S VERY EXCITING
THINK ABOUT THESE CONTRACEPTIVE
ALTERNATIVES WHICH ARE CLEARLY
IMPORTANT IN TODAY'S
ENVIRONMENT.
I THINK LET'S TAKE A FEW
QUESTIONS WHILE THE MATERIAL IS
TOP OF MIND AND THEN WE WILL END
THE SESSION WITH YOUR INTERVIEW
WITH YOUR PARTICIPANT.
WE WILL HAVE CLOSING THOUGHTS
BUT WE ARE DOING WELL WITH
TIMING.
SO, QUESTIONS?
SO LET ME JUST, I'M JUST CURIOUS
ARE PARTICIPANTS REIMBURSED FOR
PARTICIPATING?
>> YES, YEAH AND I THINK IT'S
JUST SHOWING YOU GUYS HOW MANY
PATIENTS WE CONSENT AND ENROLL
AND ULTIMATELY COMPLETE, I MEAN,
YOU KNOW THESE ARE REALLY
DIFFICULT STUDIES BECAUSE NOT
ONLY DO YOU HAVE TO COORDINATE
YOUR ACTIVITIES AS THE
PARTICIPANT BUT YOU HAVE TO YOU
KNOW COORDINATE YOUR MALE
PARTNER, YOU KNOW MOST OF OUR
PATIENTS ARE FULL-TIME EMPLOYED,
THEY HAVE CHILDREN, THIS WAS
OVER COVID, YOU KNOW WHEN THEY
WERE TRYING TO DO, VIRTUAL
SCHOOLING, SO, ALTHOUGH THE
VISITS ARE NOT THAT LONG AND WE
DO A REALLY GOOD JOB OF
RESPECTING OUR PARTICIPANTS
TIME, YOU KNOW OVULATIONS CAN
CONSIDER ON WEEKENDS, HOLIDAYS,
CAN OCCUR WHEN YOU'RE KID IS,
YOU KNOW SENT HOME FOR COVID,
YOU KNOW SO IT'S JUST--I THINK
IT'S REALLY LOGISTICALLY
DIFFICULT AND WE DO, WE IN
GENERAL WE REIMBURSE THEM ABOUT
$75 FOR A CERVICAL MUCUS CHECK
AND WE REIMBURSE THEM $150 FOR A
PC T VISIT.
BECAUSE THEY HAVE TO ABSTAIN
FROM INTERCOURSE, THEY HAVE TO
BE CHECKING THEIR URINE AT HOME
AND THIS IS A NAVY TOWN HERE SO
PEOPLE WERE CRAZY SHIFTS SO WE
HAD A LOTTED OF PATIENTS WHOSE
PARTNERS WORKED THE NIGHT SHIFT,
SO, ANYWAY, WE DO REIMBURSE
THEM, PROBABLY NOT ENOUGH.
ONE OTHER THING I WANT TO SAY
AND I THINK YOU WILL GET THIS A
BIT FROM OUR PARTICIPANT, YOU
KNOW THESE WOMEN HAVE NO NEED
FOR THIS PRODUCT, RIGHT?
THEY HAD THEIR TUBES TIED,
THEY'RE IN SUPPORTIVE
RELATIONSHIPS WITH MALE PARTNERS
THAT WILL VOLUNTEER FOR STUDIES,
SO, THERE'S NOT A LOT IN IT FOR
THEM IN TERMS OF FUTURE
PRODUCTS, BUT I THINK THEY PUT
UP WITH THESE INCONVENIENCES
BECAUSE THEY BELIEVE THAT WOMEN
NEED OPTIONS, COUPLES NEED
OPTIONS AND I THINK THAT THAT'S
WHAT I LOVE ABOUT OUR
PARTICIPANTS AND THAT'S MEN AND
WOMEN I LOVE ABOUT CLINICAL
RESEARCH.
>> THAT'S GREAT.
WELL YOU'RE GETTING POSITIVE
COMMENTS IN THE CHAT BOX BUT
LET'S GO TO MELISSA MILLER WHO
HAS HER HAND UP.
>> YEAH, SURE, THANK YOU AND
ANNIE IS THIS IS JUST FANTASTIC,
BACK IN THE DAY WHEN I WAS DOING
RESEARCH, I WAS IN CONTRACEPT
DEVELOPMENT SO HEARING ABOUT
THIS IS JUST FANTASTIC.
BUT MY QUESTION TO YOU IS
HOW--THAT 30 MINUTE WINDOW
BETWEEN INSERTION AND
INTERCOURSE AND HOW REREALISTIC
YOU THINK THAT IS OR HOW
NECESSARY YOU THINK THAT 30
MINUTE TIME WINDOW IS?
>> RIGHT, SO, OUR TEAM HAS
THOUGHT A LOT ABOUT THIS, THE
VAGINAL CONTRACEPTIVE AND 9
FILM, THE LABELING IS 15 MINUTES
BEFORE INTERCOWERS.
WE ACTUALLY HAD A FEW PATIENTS
IN OUR ACCEPTABILITY
QUESTIONNAIRE SAY THEY THOUGHT
MAYBE 30 WAS A BIT TOO LONG SO
WE ACTUALLY FOR FUTURE STUDIES,
WE HAVE PLANNED THAT WE'RE GOING
TO ASSESS DISSOLVABILITY OF THE
FILM AT LIKE ANYWHERE FROM 15
MINUTES AND WE'RE ALSO GOING TO
ASSESS PK, UP TO LIKE MAYBE 4 OR
8 HOURS AFTER INSERTION, BECAUSE
YOU KNOW AUTOSUPER IMPORTANT
THAT THESE PRODUCTS FIT INTO AN
END USER'S LIFESTYLE, SO THERE
MIGHT BE SOMEBODY WHO YOU KNOW A
WOMAN IS GOING OUT ON A DATE,
THINKS SHE'S GOING TO HAVE SEX
THAT NIGHT SO COULD SHE PUT THE
FILM IN AND WOULD THERE BE
ENOUGH ANTIBODY PRESENT 8 HOURS
LATER, WE THINK FROM THE MB66
STUDIES, THAT THERE WILL BE AND
REMEMBER, WE--OH I DIDN'T
MENTION THIS, WE NOT ONLY DID
THE PC T VISIT BUT WE HAD THE
PATIENTS COME BACK 24 HOURS
LATER AND WE DID SOME LIKE PK
SAMPLING, SO WE WILL HAVE THAT
DATA FROM THIS, BUT WE'RE
GOING--WE KNOW THAT IT'S
IMPORTANT TO GIVE PEOPLE A RANGE
OF TIMES WITH USE AND SO WE ARE
GOING TO TEST THAT IN FUTURE
STUDIES.
YEAH, FOR SURE.
>> EXCELLENT.
THANK YOU.
DR. GENERATED VEEF FEEL PERRY IS
RAISING HER HAND.
CAN YOU COME ON VIDEO?
>> I'M TRYING.
THERE YOU ARE, THAIRNG YOU SO
MUCH FOR THE WONDERFUL TALK, I
APOLOGIZE BUT I LOST CONNECTION
FOR A MOMENT AND WHAT I WANTED
TO KNOW WAS JUST IN TERMS OF
SIDE EVENS AND WHAT I DIDN'T
CATCH IS REVERSIBILITY?
IS THIS REVERSIBLE?
>> YEAH, SURE SO IN TERMS OF
SIDE EFFECTS, WE--LIKE ANY
RESEARCH STUDY, WE QUERY THE
FEMALE PARTICIPANTS, YOU KNOW AT
EVERY VISIT.
WE HAD THE FEMALES, REPORT ABOUT
MALE GENITO-URNANNYAD VERSE
EVENTS ABOUT YOU WE CALLED HIM
DIRECTLY AND ASKED HIM ABOUT
GENITO-URINARY ADVERSE EVENTS
ABOUT 24-72 HOURS AFTER EXPOSURE
TO THE STUDY PRODUCT, OKAY, SO,
AND WE DID NOT HAVE ANY PROD
YOUUCT OR PROCEDURE RELATED
ADVERSE EVENTS.
I THINK THE BIG TAKE HOME
MESSAGE IS NOT ONLY DID WE NOT
HAVE ADVERSE EVENTS BUT PEOPLE
JUST--LIKE THE MEN DIDN'T KNOW
IT WAS THERE.
THE WOMEN DIDN'T KNOW IT WAS
THERE.
IT WAS 1 EXPOSURE, BUT YOU KNOW
WE DID NOT HAVE ANY PROBLEMS.
AND THEN YOU ALSO ASKED ABOUT
REVERSIBILITY, YEAH, SO I
BROUGHT THIS UP.
THEY WERE ORIGINALLY GOING TO DO
A SAFETY STUDY AT ANOTHER CENTER
IN WOMEN WHO WERE JUST NOT AT
RISK OF PREGNANCY, THEY WERE ON
CONTRACEPTION, ABOUT YOU IT CAME
UP AT OUR SCIENTIFIC ADVISORY
BOARD, LIKE, LYOU DON'T WANT TO
EXPOSE WOMEN WHO MAY WANT TO
HAVE A BABY IN THE FUTURE TO
A--TO AN ANTISPERM ANTIBODY,
WHAT IF, EVEN THOUGH WE THOUGHT
THE CHANCE WAS VERY REMOTE AND
OUR PAST DAT - MB66 REPORT THAT,
THEN IT IS ABSOLUTELY
REVERSIBLE, IT PROBABLY STAYS IN
THEIR SYSTEM FOR ABOUT 24 HOURS,
WE DID TEST THE REVERSIBILITY,
WE HAD THEM, YOU KNOW THEY USED
PRODUCT IN 1 CYCLE AND THEN WE
HAD THEM DO A PC T CYCLE A MONTH
LATER AND WE DEMONSTRATED, YOU
KNOW, THEY WERE BACK TO NORMAL
SPERM CERVICAL MUCUS INTERACTION
SO THIS IS ABSOLUTELY REVERSIBLE
AND THAT'S SUPER IMPORTANT TO
WOMEN, YOU KNOW, SO DEFINITELY.
YEAH.
>> THANK YOU.
>> OH, GO AHEAD MARTY.
>> YEAH, DOCTOR, I JUST WANT TO
SAY THAT THIS WAS REALLY A
BEAUTIFUL PRESENTATION AND I
WANT TO THANK YOU OF YOUR STTDS
AND YOU COULD BE OUT MAKING A
LOT MORE MONEY THAN DOING THESE
STUDIES AND I THINK THAT
EVERYONE SHOULD APPRECIATE YOUR
INVOLVEMENT, ALL THESE CLINICAL
STUDIES, NOT ONLY THE 1 YOU
PRESENTED BUT THE OTHER 1S
YOU'VE BEEN DOING.
>> YEAH, I'M A NAVY DOC AND
ACADEMIC, SO WHAT MOTIVATES ME
IS DEVELOPING MORE OPTIONS FOR
COUPLES AND OUR PATIENTS ARE
WONDERFUL, OUR COLLABORATORS ARE
WONDERFUL, SO ... YOUR TAX
DOLLARS PAID FOR ME TO GO TO MED
SCHOOL.
YOU'RE.
>> SO WOULD A WOMAN BE ABLE TO
CARRY THIS IN HER PURSE AND
INSERT IT AT THE APPROPRIATE
TIME AND HOW STABLE IS THE FILMK
AND THE ANTIBODY?
>> RIGHT, SO, I CAN ALSO DEFER
THIS, I DON'T KNOW IF ANY OF MY
COLLEAGUES FROM ZAB, BIOBUT WE
DID NOT STORE THESE IN THE
REFRIGERATOR THEY WERE STORED AT
ROOM TEMPERATURE, THEY'RE
PACKAGED IN SEALED FOIL
PACKAGES, I DO THINK THAT WOULD
BE IMPORTANT THAT THEY'RE
DISCREET, YOU KNOW, SO, YES, A
WOMAN COULD YOU KNOW TAKE THE
FILM OUT OF THE PACKAGE AND
INSERT IT AND I THINK THAT'S
ANOTHER REASON WHY WE WANT TO
LOOK AT VARIATIONS IN THE TIME
OF INSERTION TO INTERCOURSE
BECAUSE, YOU KNOW SOME WOMEN
WOULD NOT WANT THEIR MALE
PARTNERS TO KNOW AND MIGHT WANT
TO INSERT IT HOURS BEFORE
EXPECTED INTERCOURSE.
JUST OF NOTE, WE EXAMINED THE
PATIENT 2-3 HOURS AFTER THEY USE
THE PRODUCT WITH INTERCOURSE, WE
NEVER SAW ANY REMNANTS OF FILM
OR ANYTHING LIKE THAT.
CERTAINLY WAS DISSOLVED AT THAT
TIME AND IT WAS--IT WORKED
RIGHT?
I MEAN THERE WAS NO MODAL SPERM
2-3 HOURS LATER.
>> THAT'S GREAT.
I THINK WE WILL MOVE ALONG.
SO FOR THOSE OF YOU WHO ARE
FAMILIAR, WITH OUR ADVISORY
COUNCIL MEETINGS, YOU KNOW THAT
WE REGULARLY FEATURE A SEGMENT
CALLED THE VOICE OF THE
PARTICIPANT.
THIS GIVES US A CHANCE TO HEAR
FROM THOSE WHO REALLY HAVE THE
LIVED EXPERIENCE RELATED TO THE
RESEARCH THAT NICHD FUNDS AND
THIS YEAR WE'RE VERY GRATEFUL
BECAUSE DR. THURMAN HAS
INTERVIEWED 1 OF HER
PARTICIPANTS MISS TIFFANY WHITE
WHO HAS KINDLY AGREED TO PROVIDE
THE INTERVIEW FOR THIS COUNCIL
MEETING, SO DR. THURMAN COULD
YOU INTRODUCE MISS WHITE'S ROLE
IN THE STUDY AND LET US KNOW
WHEN TO START THE VIDEO.
>> YEAH, SO, MISS
WHITE--MESSRS. WHITE WAS A
PARTICIPANT IN THE STUDY.
THIS WAS HER FIRST STUDY SHE DID
WITH US AND SHE'S AN EMPLOYEE AT
EASTERN VIRGINIA MEDICAL SCHOOL,
SHE'S ACTUALLY ON VACATION TODAY
SO WE PRERECORDED OUR INTERVIEW
BUT SHE--I THINK SHE WILL ANSWER
A LOT OF YOUR QUESTIONS AND I
KNOW HER WELL, SO I WOULD BE
HAPPY TO ANSWER ADDITIONAL
QUESTIONS ON HER BEHALF.
I CAN SHARE THE VIDEO IF YOU
WOULD LIKE.
ALL RIGHT, HERE WE GO.
YOU CAN SEE MY SCREEN?
>> YES.
>> GREAT.
I WILL START IT.
THE SOUND IS MUTED ON THE VIDEO
HOW'S THAT.
>> WE CANNOT HEAR THE SOUND ON
THE VIDEO.
WOULD YOU LIKE US TO GO AHEAD
AND SHARE IT.
>> YES.
I'M SORRY, I DON'T KNOW WHAT'S
GOING ON.
SIEM SORRY, I DON'T KNOW WHY
IT'S NOT DOING THAT.
>> HI, I'M ANNIE, THURMAN, THIS
IS MRS. WRITE, SHE WAS 1 OF THE
PARTICIPANTS IN OUR P50 TRIAL
AND WE WERE GOING TO CHITCHAT
ABOUT HER EXPERIENCE IN THE
TRIAL AND A LITTLE BIT ABOUT
HER.
SO, MRS. WRIGHT TELL THE
AUDIENCE, TELL ME ABOUT
YOURSELF.
>> SO I AM 40 YEARS OLD, 40
YEARS OLD AND I HAVE 2 KIDS,
TEENAGER AND A 7 YEAR-OLD, AND I
WORK HERE WITH EVMS.
AND YOU QUALIFIED FOR THE TRIAL
BECAUSE YOU'RE YOUNG AND HEALTHY
AND YOU HAD YOUR TUBES TIED.
>> I DID, I HAD THE ESURE
PROCEDURE DONE RIGHT AFTER MY
YOUNGEST SON WAS BORN SO ABOUT 7
YEARS AGO AND REALLY NICE, SILL
GET MY MENSES, THAT DOESN'T
AFFECT ME THAT MUCH WHICH WAS 1
OF THE THINGS THAT ALLOWED ME TO
DO THE STUDY.
>> WHAT HAD YOU PREVIOUSLY USED
FOR BIRTH CONTROL?
>> I DID THE PATCH, I'VE DONE
THE PILL, I'VE DONE THE RING,
I'VE DONE THE SHOT, THE OHM
THING I HAVEN'T DONE WAS THE
IUD.
>> DID YOU EVER DO THE IMPLANT.
>> NO.
>> AND SO, WITH THE 1S THAT YOU
DID IN THE PAST THOSE WERE
MOSTLY HORMONAL, RIGHT?
PATCH, PILL, RING AND SHOT THOSE
ARE ALL HORMONAL.
>> YEAH.
>> SO DID YOU HAVE ANY SIDE
EFFECTS WITH IT, OR DID HAVE YOU
BENEFITS FROM IT?
>> YEAH, THEY JUST THROUGH MY
HORMONES REAL OFF AND MY CYCLES
WERE OFF AND I DIDN'T LIKE THAT,
I DIDN'T LIKE JUST THE IMPACT
THAT THE ADDITIONAL HORMONES HAD
ON MY BODY BECAUSE IT WOULD
JUST--YOU'RE OKAY 1 MINUTE AND
THEN YOU'RE OFF IN LEFT FIELD
THE NEXT.
SO ... [LAUGHTER]
>> AND THEN IN TERMS OF GOING TO
SOMETHING NONMORMOANAL, YOU
DECIDED TO GO WITH THE TUBAL
LIGATION OR THE TUBAL
STERILIZATION FOR--YOU DIDN'T
WANT TO BE ON HORMONES BUT THERE
ARE OTHER NONHORMONAL OPTIONS
LIKE A COPPER IUD OR CONDOMS,
STUFF LIKE THAT, SO HAD YOU
CONSIDERED THE COPPER IUD?
>> I DID AND I DID MY RESEARCH
WHEN IT CAME TO THE IUDs, I
REALLY DID BECAUSE MY SISTER
ACTUALLY HAS 1.
BUT THERE'S SO MANY STORIES OF
WOMEN STILL GETTING PREGNANT
WITH THE IUDs THAT IT JUST
SCARED ME AND MY 2 KIDS ARE 9
YEARS APART RIGHT NOW AND I DID
NOT WANT ANOTHER THIRD CHILD 9
YEARS LATER AND I JUST KNEW I
WAS DONE.
I KNEW I WAS DONE HAVING KIDS
AND--SO STERILIZATION WAS JUST
THE BEST COURSE FOR ME.
AND SO, JUST FOR OUR AUDIENCE, A
LOT--YOU KNOW WE DID THE ESURES
WHICH IS A EFTHIMIOS ROW SCOPPIC
PROCEDURE IN THE OFFICE, YOU HAD
YOURS DONE, RIGHT?
AND THEN DID YOU GO TO WORK THAT
DAY OR YOU WENT HOME THAT DAY.
>> I WENT HOME THAT DAY AND
THEN, THE NEXT DAY,IVE WAS TOTAL
FINE, THERE WAS NO ISSUES, THERE
WAS NO SORENESS.
SORENESS TO THE POINT WHERE YOU
CAN'T DO ANYTHING.
AS THE SCAR TISSUE GROWS YOU CAN
KIND OF, YOU KNOW YOU COULD FEEL
IT BUT ONCE IT WAS DONE AFTER 2
MONTHS, THAT WAS IT, THERE WAS
NO MORE ISSUES, I WAS ABLE TO
GET TESTED TO MAKE SURE THAT
THERE WAS, THE BLOCKAGE WAS
SEALED COMPLETE AND AFTER THAT I
DIDN'T HAVE A PROBLEM WITH IT.
>> YEAH, THAT'S' ACTUALLY AN
IMPORTANT POINT.
THE NICE THING ABOUT THE ESURE
IS THEY DID A HISTOCELL
PINGOGRAM AFTERWARD TO MAKE SURE
THAT YOUR TUBES WERE SCARED AND
SHUT SO I THINK THAT GIVES
PEOPLE A LOT OF REASSURANCE.
UNFORTUNATELY, NOW, THE ESURE IS
NOT AN OPTION WHICH IS, YOU KNOW
LIMITS PEOPLE'S OPTIONS FOR
PERMANENT STERILIZATION, THERE
WERE NO, YOU KNOW ENOUGH PEOPLE
THAT HAD TROUBLE WITH THESE
NICKEL INSERTS THAT FRANKLY, I
THINK IT WAS A BUSINESS
DECISIONOT PART OF BAYER THAT
THEY JUST DECIDED TO STOP
MARKETING IT IN THE U.S., I
THINK IT'S STILL AVAILABLE IN
OTHER COUNTRIES, BUT, SO
THAT'S--IT'S UNFORTUNATE BECAUSE
I MEAN, YOU KNOW 99% OF PEOPLE
DO--DID GREAT ON THE ESURE BUT
THERE WERE A FEW LAWSUITS, I
MEAN WHEN YOU START HAVING
MILLIONS OF WOMEN, USING A
PRODUCT, YOU'RE GOING TO GET
SOME SIDE EFFECTS AND STUFF AND
THEY JUST--I THINK THEY MADE
BUSINESS DECISION THAT IT WASN'T
WORTH IT.
>> I LOVE MINE.
I HAVE NO COMPLAINTS WITH MINE.
>> WELL, GOOD, BUT IF NOW IF YOU
WANT A TUBAL LIGATION, YOU HAVE
TO HAVE IT @ TIME OF CAESAREAN
SECTION.
>> I DID, MY LAST 1 WAS A
C-SECTION.
>> OKAY, BUT YOU WEREN'T READY
AT THAT POINT.
YOU DIDN'T CONSENT TO HAVING A
TUBAL LIGATION AT YOUR
C-SECTION.
>> I HAD ALREADY CONSENTED TO
HAVE THE ESURE PROCEDURE DONE
AND I ACTUALLY HAD IT DONE HERE
AT EVMS, WITH
DR. [INDISCERNIBLE] AND SO,
SHE--SO, IT WAS ALREADY IN PLAY.
SO I WENT AHEAD AND MY C-SECTION
WAS ACTUALLY PLANNED, IT WAS
KIND OF AN EMERGENCY C-SECTION.
>> SO THEY'RE NOT REALLY THINK
BEING LET'S DO YOUR TUBAL.
>> YEAH.
>> GOT IT.
OKAY.
SO RIGHT NOW, IF YOU WANT TO
HAVE YOUR TUBES TIED, YOU EITHER
HAVE TO HAVE IT DONE AT THE TIME
OF C-SECTION WHICH YOU KNOW SOME
WOMEN WANT TO HAVE THAT DONE,
BUT THERE'S CIRCUMSTANCES WHERE,
YOU KNOW, I MEAN, THE GOAL OF
THE C-SECTION IS TO PROTECT YOUR
HEALTH AND THE BABY'S HEALTH,
NONAPOPTOTIC THE TO PERFORM A
STERILIZATION PROCEDURE, RIGHT?
AND THEN THE OTHER OPTION, LIKE
I SHOWED IN THE SLIDES, IS TO
HAVE A LAPROSCOPIC PROCEDURE IN
THE OPERATING ROOM SO IT'S
UNFORTUNATE THAT YOU CAN'T DO
LIKE AN OUTPATIENT PROCEDURE
ANYMORE.
OKAY, SO LET'S TALK A LITTLE BIT
ABOUT--SO YOU HAVE NONHORMONAL
PERMANENT CONTRACEPTION THAT YOU
LIKE A LOT.
>> YEAH.
>> SO, YOU KNOW YOU DON'T NEED
THIS PRODUCT, THIS FILM, SO WHAT
WERE SOME OF YOUR MOTIVATIONS
FOR BEING A TRIAL PARTICIPANT.
>> I'M ALWAYS OPEN TO WHAT ELSE
THERE IS, EVEN THOUGH I KNOW
THAT MY--I CAN'T GET PREGNANT SO
THAT'S NOT EVER A WORRY BUT JUST
TO SEE WHRA THERE IS AND WHAT
OTHER OPTIONS THERE ARE FOR
WOMEN IN GENERAL IS ALWAYS A
GOOD THING TO KEEP IN MIND
BECAUSE YOU MEET SO MANY PEOPLE
THROUGHOUT THE DAY THAT YOU WANT
TO OFFER SUGGESTIONS, BUT YOU
DON'T KNOW WHAT THEY ARE IF YOU
JUST STAY WITHIN YOUR LANE.
>> YEAH.
>> SO I JUST THINK INFORMATION'S
POWER.
>> AWESOME.
>> YEAH, FOR SURE.
>> AND I JUST WANT TO MAKE A
NOTE THAT MRS. WRIGHT DOES WORK
IN THE OBGYN DEPARTMENT, THAT'S
WHY WE'RE MATCHING.
>> YEAH, SO WE GET A LOT OF
EMPLOYEES THAT ARE IN OUR
STUDIES AND I DO THINK IT'S
REALLY IMPORTANT BECAUSE PEOPLE
HAVE SOME HESITATION TO BE IN
RESEARCH, YOU KNOW, OBVIOUSLY,
YOU KNOW IN THE SOUTHERN U.S.,
DIFFERENT RACIAL AND ETHNIC
GROUPS HAVE SOME VERY, YOU KNOW
GOOD REASONS TO BE SUSPICIOUS
ABOUT RESEARCH, SO I THINK IT'S
NICE WHEN WE GET PEOPLE IN OUR
STUDIES THAT YOU KNOW, WANT TO
BE IN IT FOR THE RIGHT REASONS
ISSUES WANT TO SPREAD THE
INFORMATION AND AS YOU AS A
PATIENT CARE, LIAISON, YOU CAN
TELL PEOPLE ABOUT DIFFERENT
OPTIONS, WHAT IT'S LIKE TO BE A
RESEARCH PARTICIPANT, ALL THAT
KIND OF STUFF.
>> YEAH, I THINK IT DEFINITELY
GIVES THAT PERSONAL TESTIMONY,
DEFINITELY HELPS WHEN IT'S IN 1
OF YOU'RE TALKING TO DIFFERENT
PATIENTS ABOUT DIFFERENT
OPTIONS.
YOU KNOW FOR EXAMPLE, WHEN I HAD
MY ESURE PROCEDURE, I TOLD EVERY
PATIENT I TALKED TO ABOUT IT,
AND THEY WERE LIKE I HEARD SO
MANY NEGATIVE THINGS BUT I
HAVEN'T HAD THAT AND THAT'S A
VERY SMALL CLASS, THEY
DEFINITELY NEED TO TALK TO YOUR
DOCTOR ABOUT IT SO I THINK IT'S
JUST WHEN IT COMES TO THE TRIAL,
SCENARIOS, ME BEING ABLE TO
PERSONALLY GONE THROUGH IT IT'S
JUST ANOTHER TESTIMONY OF MINE
WHERE I CAN TELL THE PATIENT, OH
NO I'VE ALREADY DONE THAT,
THAT'S ACTUALLY A REALLY GOOD
PRODUCT, YOU NEED TO TALK TO
YOUR DOCTOR.
>> YEAH, YEAH AND WHAT DO YOU
THINK, LIKE, THIS PRODUCT IT'S A
VAGINAL FILM AND YOU KNOW
THERE'S VAGINAL FILMS THAT ARE
AVAILABLE OVER THE COUNTER LIKE
NONOXYL 9.
>> I HAVEN'T TRIED THE--THE
PLEASURE TO TRY THOSE YET.
>> YES, WELL THIS 1'S NOT OUT
BUT THERE ARE OTHER 1S WITH
OTHER CHEMICALS IN THEM, SO THIS
1 EANTD SPERM ANTIBODIES IN IT,
BUT WHEN I SAY ANTISPERM
ANTIBODIES WHAT DO YOU OR YOUR
HUSBAND THINK?
>> WHEN I FIRST TOLD HIM AS ANY
MAN WOULD, HE WENT WHAT?
BUT ONCE WE HAD IT INSERTED AND
WE HAD INTERCOURSE, HE COULDN'T
TELL, I ASKED HIM ABOUT IT
AFTERWARDS, NO, I FORGOT WHAT WE
WERE DOING, IT'S EXCITING SO
THERE WAS NO REPERCUSSION ON HIS
SIDE IN REGARDS TO THE PLEASURE
OF THE ACTUAL ACT.
>> AND JUST A NOTE LIKE IN TERMS
OF ACCEPTABILITY, AGAIN, AS
MRS. WRIGHT HAS SAID, SHE IS NOT
AN ULTIMATE END USER OF THIS
PRODUCT, SO LIKE, IF I WERE TO
ASK YOU, LIKE, OH WOULD YOU USE
THIS PRODUCT IN THE FUTURE,
LIKE, NO, YOU WOULDN'T.
>> I DON'T NEED TO.
>> RIGHT AND WE TELL PATIENTS IN
OUR TRIALS, LIKE, LISTEN, IT'S
NOT GOING TO HURT MY FEELINGS IF
YOU TELL ME BAD THINGS ABOUT
THIS PRODUCT AND IN FACT, THESE
FIRST IN WOMAN STUDIES ARE
REALLY THE TIME THAT WE'RE GOING
TO FIND SOME IF THERE ARE
STRONGLY NEGATIVE REACTIONS TO
THE PRODUCT, THIS IS THE TIME TO
FIND IT OUT.
YOU KNOW?
AND WE HAD THAT HAPPEN IN A
PREVIOUS PHASE 1 STUDY.
AGAIN, THESE PHASE 1 POPULATIONS
ARE VERY HEALTHY.
THE PC T TRIALS ARE WOMEN THAT
HAVE TUBAL LIGATIONS, SO THEY'RE
NOT THE ULTIMATE END USERS BUT
YEAH, I MEAN--I THINK YOUR
EXPERIENCE AT LEAST
ACCEPTABILITY, PARTICULARLY YOUR
HUSBAND'S ACCEPTABILITY OF IT,
IS PRETTY CONSISTENT, IT WAS
REALLY JUST FORGOT ABOUT IT.
DID HAVE YOU ANY TROUBLE
INSERTING THE FILM BECAUSE WE
HAD A FEW PEOPLE THAT HAD MAYBE
STICKINESS OR SOMETHING.
>> YEAH, INITIALLY, THE FIRST
TIME I DID IT, I HAD TO DO IT
TWICE, BECAUSE THE FILM DOES GET
EXTREMELY SICKY ONCE YOU GET IT
WET, SO YOU KIND OF HAD TO WORK
WITH FLICKING IT, YOU HAVE TO
THEM PRACTICE WITH IT BUT AFTER
THE SECOND TIME, I WAS LIKE,
OKAY, NOW I GET IT.
AND THEN ONCE YOU JUST INSERT
IT, YOU JUST WASH YOUR HANDS SO
THAT WAS PRETTY MUCH IT.
BUT I THINK THE MORE YOU USE IT,
THE EASIER IT GOT--THE EASIER IT
IS.
>> YEAH, AND IN THIS STUDY WE
HAD YOU INSERT A VAGINAL
CONTRACEPTIVE FILM AT THE
SCREENING VISIT TO MAKE SURE YOU
COULD DO IT, BUT WE--I REMEMBER
WE WOULD GIVE PEOPLE LIKE 2
FILMS BECAUSE WHEN YOU TOOK THAT
FILM HOME, I MEAN, A LOT OF
TIMES OUR PARTICIPANTS HAD TO
HAVE SEX LIKE REALLY EARLY IN
THE MORNING SO THEY COULD COME
IN 2-3 HOURS LATER BEFORE WORK
OR WHATEVER, AND YOU KNOW WE
DIDN'T WANT TO YOU HAVE A
PROBLEM WITH IT AT 3 OUR 4:00 IN
THE MORNING.
>> YES.
>> SO, OKAY AND THEN SO, MY
RECOLLECTION IS THINGS WENT VERY
SMOOTHLY WITH YOUR VISITS BUT,
THAT'S NOT ALWAYS THE CASE WITH
ALL OF OUR PARTICIPANTS.
WE ACTUALLY ENROLLED LIKE 20
PEOPLE IN THIS STUDY AND 8
COUPLES COMPLETED ALL THE
VISITS.
>> OH, OKAY.
>> SO TELL ME AUDIENCE A LITTLE
BIT ABOUT WHAT IT WAS LIKE TO BE
MONITORING YOUR URINE FOR
OVULATION?
>> AND AGAIN YOU CAN COMPLAIN.
>> FORTUNATELY, ACTUALLY WE HAVE
REALLY, REALLY GOOD STAFF HERE
WHEN IT COMES TO THE TRIALS.
I HAD MISS JAMIE SHE WOULD TEXT
ME THE DAY OF, DON'T FORGET TO
CHECK YOUR URINE.
>> OKAY, GOT IT.
I ALSO MADE SURE I PUT A
REMINDER ON MY PHONE AND THEY
WERE ABLE--THEY WERE REALLY
NICE, THEY GAVE ME THE CUPS SO I
WOULDN'T HAVE TO DO IT WHILE
URINATING BUT THEN I WILL PEE IN
THE CUP AND CHECK IT AND JUST
SEND A PICKURE EVERY MORNING AND
THEN ONCE I GOT THE SMILEY FACE,
I WOULD COME INTO THE CLINIC AND
IT WAS REALLY, REALLY EASY,
EVERYBODY WAS REALLY REALLY NICE
AND WORK WITH MY SCHEDULE.
MAKING WORKING HERE AT EVMS
REALLY NICE BUT SOMETIMES IT WAS
A LITTLE BIT MORE DIFFICULT.
BUT NO, JUST TRIAL WAS REALLY
SIMPLE TO DO.
>> BUT I DO THINK IT'S WORTH
NOTE THAGOREAN 1 OF THE STUDY
COORDINATORS, JAMIE, YOU KNOW
YOU WOULD ACTUALLY TEXT HER A
PICTURE OF YOUR URINARY
LIEUTENNIZING HORMONE RESULT
EACH DAY.
>> EVERY MORNING.
>> AND THEN ONCE YOU WERE
POSITIVE, OR, VIEWLATTORY, YOU
HAD THE SURGE, YOU HAD TO GET IN
HERE WITHIN ABOUT 24 HOURS TO
GET THE CERVICAL MUSEUM TUS
CHECK AND DID WE--I THINK
REMEMBER WE LET YOU LOOK AT YOUR
CERVICAL MUCUS AND.
>> YES, IEE, AUDIENCE PARENTALLY
I HAVE WONDERFUL, CERVICAL
AOCCURREDDING TO DEE, WONDERFUL
CERVICAL MUCUS AND IT WAS
ACTUALLY PRETTY COOL TO LOOK AT
IT AND I WAS ABLE TO SEE IT
UNDERNEATH A MICROSCOPE AND I
WAS ABLE TO SEE THE CERVICAL
MUSEUMUS AFTER THE PRODUCT AND
SEE THERE WAS NO THE DIFFERENCE
BETWEEN--BEFORE THE PRODUCT AND
AFTER THE PRODUCT WHERE I WAS
ABLE TO SEE THE SPERM AND THEN
ACTUALLY NO SPERM.
SO THAT WAS REALLY, REALLY COOL
TO SEE.
BUT, YEAH, I WOULD COME IN TO
HAVE THE CERVICAL MUCUS DONE AND
THEN ALL OF THE TESTING DONE AND
THEN, I GOT THE OKAY TO HAVE
SEX.
>> AND YOU GUYS HAD TO ABSTAIN
FOR A WHILE BEFORE.
>> RIGHT, 3 DAYS?
, 3 DAYS.
>> RIGHT.
>> I BELIEVE IT WAS UNTIL I GOT
THE HAPPY FACE.
SO ONCE I STARTED, ONCE I
STARTED CHECKING MY OVULATION,
THEN WHY HAD TO ABSTAIN UNTIL I
GOT THE HAPPY FACE THEN I CAME
INTO THE CLINIC AND THEN WE WERE
ABLE TO HAVE SEX.
>> RIGHT.
>> AND THEN, DID YOU EVER HAVE
TO COME IN ON THE WEEKEND, I
CAN'T REMEMBER?
>> NO, FORTUNATELY EVERYTHING
HAPPENED DURING THE WEEK.
>> GOOD, GOOD.
AND THEN, I MEAN, YOU WORK 4-10
HOUR SHIFTS HERE SO YOU GET IN
PRETTY EARLY SO BASICALLY WHEN
YOU WERE DOING THE PC T VISITS
YOU AND YOUR HUSBAND HAD TO HAVE
SEX REALLY EARLY IN THE MORNING
SO THAT YOU COULD THEN WAIT 2-3
HOURS AND YOU KNOW AT FIRST WE
WERE LIKE WELL WHY DO WOE HAVE
TO WAIT 2-3 HOURS BUT I GUESS IT
LITTLE TIME TO SWIM. THE SPE-M A
>> BECAUSE YOU HAVE TO PUT YOUR
LELGS UP IN THE AIR TO MAKE
SURE, EVERYTHING'S STAYS IN, I'M
LOOK, OKAY, SO THAT WAS PRETTY
INTERESTING BUT YEAH, WE HAD TO
HAVE SEX PRETTY EARLY IN THE
MORNING AND THEN I WOULD COME IN
AND MEET WITH THE LADIES AROUND
8, THEY WOULD BET LET ME KNOW,
OKAY, COME ON DOWN SO I WOULD
HURRY UP AND COME DOWN STAIRS
AND GET ALL THE TESTING DONE.
>> AND YOU KNOW, 1 OF THE BIG
PROBLEMS WE'VE HAD IS, YOU KNOW
I MEAN, YOU GUYS HAVE 2 KIDS,
YOU BOTH WORK.
YOU'RE TRYING TO HAVE THIS
PLANNED TIMED IRND COURSE,
WHATEVER, 6:00, 5:00 O'CLOCK IN
THE MORNING BEFORE WORK, AND A
LOT OF TIMES THE MALE PARTNER
WAS NOT ABLE TO PERFORM AND THAT
WAS A BIG PROBLEM FOR MANY OF
OUR PARTICIPANTS, YOU KNOW, HOW
DID THINGS GO WITH YOUR HUSBAND
OR--
>> HE HAD NO PROBLEM IN THAT.
>> OKAY.
>> AND ACCORDING TO WAS IT DEE
DEE HE HAD SPERM GALORE WAS HER
TECHNICAL TERM FOR IT.
>> OKAY.
>> BUT YEAH, NO AS FAR AS BEING
ABLE TO PERFORM ISSUES
EVERYTHING, NO, TIMING WISE IT
WAS FINE, WE DID HAVE TO
COMMUNICATE ESPECIALLY IF HE WAS
WORKING THEN WE WOULD HAVE TO
COMMUNICATE, BE LIKE OKAY, JUST
TO LET YOU KNOW, I'M GOOD SO WE
NEED TO HAVE IT BEFORE I GO TO
WORK TOMORROW TO MAKE SURE
EVERYTHING'S GOING TO CONTINUE
ON BUT IT WASN'T TOO HARD FOR
HIM?
>> AND EVEN THOUGH THE LOGISTICS
LIKE STELLA AND JAMIE THE
COORDINATORS, I AM SO BUSY
MANAGING EVERYBODY'S SEX LIFE,
YOU KNOW, BUT TD DESIGN OF THE
STUDY IS PRETTY COOL THAT YOU
KNOW YOU GUYS HAD INTERCOURSE AT
PEAK OVULATION, RIGHT?
THAT'S--SO THAT'S REALLY WHEN
YOU WOULD WANT A CONTRACEPTIVE
TO WORK AND SO IT'S KIND OF
THIS, YOU KNOW REALLY GOOD MODEL
IN HUMANS OF, YOU KNOW DOES THIS
WORK AT THE PEAK FERTILITY
MOMENT.
SO, BUT YEAH, WE KIND OF LAUGH
ABOUT COORDINATING ALL OF THIS
BUT IT IS REALLY A NEED DESIGN
THAT YOU KNOW WE'RE TIMING IN
RIGHT AT OVULATION, WE DO A BASE
LINE CYCLE TO MAKE SURE THAT
YOU'RE HUSBAND HAS NORMAL SPERM
THAT YOU KNOW ASCEND IN THE
CERVICAL MUCUS WHICH YOU SAW
HAPPENING AND WITH THE PRODUCT
THEY'RE DEAD OR NOT THERE, YOU
KNOW?
NARCS THAT WAS REALLY
INTERESTING TO SEE AND CAM PAIR,
AND YEAH, JAMIE KNEW WAY MORE
ABOUT MY SEX LIFE THAN SHE
WANTED TO BUT THE STUDY WAS
REALLY INTERESTING TO DO.
>> COOL, COOL.
AND YOU KNOW I JUST--IT'S SO
IMPORTANT, YOU KNOW WE--WE
REALLY WANT TO MAKE SURE THAT
THE PARTICIPANTS KNOW THAT, YOU
KNOW WE VALUE YOUR TIME, WE
UNDERSTAND THAT THIS IS NOT
ONLY, YOU KNOW TRYING TO
COORDINATE YOUR TIME BUT YOUR
HUSBAND'S TIME, WE DO COMPENSATE
YOU FOR YOUR TIME AND TRAVEL,
BUT, YOU KNOW, AND I MEAN WE
DON'T EXPECT YOU TO DO THIS FOR
FREE, YOU KNOW, THIS IS A LOT OF
EFFORT ON YOUR PART, YOU KNOW?
BUT I THINK IT'S REALLY GREAT
THAT PEOPLE THAT WILL NEVER NEED
THIS PRODUCT ARE WILLING TO BE
RESEARCH PARTICIPANTS.
>> YEAH AND I HAD SO MUCH FUN
I'M THINK BEING DOING ANOTHER 1.
>> A GOOD, GOOD.
>> A LOT OF TIMES WE MEET A
PATIENT, WHEN WE MEET A NICE
YOUNG LADY WITH HER TUBES TIED,
YOU CAN RUN BUT YOU CAN'T HIDE.
>> [LAUGHTER]
, MY CYCLES COME REGULARLY, 4
WEEKS MINUS A DAY, I KNOW.
>> AND ACTUALLY JUST SPEAKS
ABOUT THAT, WOMEN IN THIS TRIAL
HAD TO BE OVULEATORY BUT
SOMETIMES JUST BY BEING IN A
TRIAL IT STRESSES YOU OUT AND
YOU KNOW YOU'RE ANOVULATORY FOR
A CYCLE OR 2 EXPW WE ALLOWED
WITHEM IN THIS TRIAL THAT WERE
18 TO 50 BECAUSE WOMEN THAT ARE
GETTING THEIR TUBES TIED TEND TO
BE OLDER, RIGHT?
BUT YOU KNOW AS WE GET UP TO,
YOU KNOW 45-50, THEN WE START
WORRYING ABOUT PEOPLE NOT
OVULEATING REGULARLY BUT THAT
WASN'T A PROBLEM WITH YOU.
>> NO, NO, FORTUNATELY NOT.
JAMIE WAS VERY HAPPY WITH ME
ABOUT THAT 1.
>> GOOD, GOOD.
SO WE'VE APPLIED TO DO SOME
ADDITIONAL STUDIES WITH THIS AND
ACTUALLY THERE'S AN ADDITIONAL
STUDY WHERE YOU'RE JUST USING
THE FILM EVERY DAY FOR LIKE 14
DAYS OR 21 DAYS AND IT DOESN'T
INVOLVE YOUR HUSBAND.
SO YEAH, HOPEFUL WE HAVE SOME
FUTURE STUDIES COMING UP AND
YEAH, WE'LL GET YOU UNROLLED
AGAIN.
>> THANK YOU.
>> LET'S SEE, WHAT ELSE DO I
NEED TO ASK YOU.
YEAH, AND JUST, WHAT WOULD YOU
SAY TO, YOU KNOW WOMEN ABOUT
MAYBE USING THIS PRODUCT IN THE
FUTURE?
>> I WOULD SAY DEFINITELY GO FOR
IT.
THE ONLY THING THAT YOU DO NEED
TO KEEP MINDFUL IS THAT THE
PRODUCT DID REQUIRE, I THINK IT
WAS LIKE 15-30 MINUTES PRIOR TO
BEING SEXUALLY ACTIVE SO, IN
THAT CASE, HAVE REALLY GOOD
FOREPLAY.
BUT JUST BE MINDFUL OF THAT IN
THAT SCENARIO, YOU KNOW MPLET IT
WASN'T AFTER AN ISSUE IN MY CASE
BECAUSE AGAIN, WE WOULD--WE
WOULD HAVE THAT CONVERSATION
PRIOR TO SO WE DID--I WOULD
INSERT IT, GO ABOUT, DO WHATEVER
I NEEDED TO DO AND THEN YOU KNOW
THEN HAVE SEX, BUT AS FAR AS
PRODUCT USAGE, ONCE YOU GOT THE
HANG OF IT, IT WAS REALLY,
REALLY EASY AND IT WAS REALLY
NICE TO KNOW THAT IT STOPPED ALL
SPERM, IT KILLED OFF ALL SPERM,
YOU DIDN'T HAVE TO WORRY ABOUT
IT, YOU DON'T HAVE TO GET
THROUGH THAT 1 LITTLE BOOGER
THAT WOULD GET IF THERE, IT ONLY
CAUSES 1.
BUT I SAY GO FOR IT.
I REALLY LIKED IT.
>> GOOD, GOOD.
AND IT'S JUST, YOU KNOW IT'S I
THINK IT'S A NICE OPTION FOR,
YOU SAID YOU DIDN'T LIKE THE
IDEA OF A COPPER IUD, RIGHT?
AND MANY WOMEN SAY THAT, YOU
KNOW THEY JUST DON'T WANT
SOMETHING UP INSIDE THEIR
UTERROUS, RIGHT?
AND IF THEY'RE NOT READY TO GET
THEIR TUBES TIED, THEN THE
NONHORMONAL OPTIONS THERE'S A
GAP THERE, THERE'S CONDOMS,
THERE'S DIAPHRAGMS, YOU KNOW,
BUT THERE WERE SPERMICIDES BUT
SOME OF THE SPERM TIDES SOUGHT
THERE CAN CAUSE A LOT OF
INFLAMMATION AND CHANGE YOUR
VAGINAL MICROBIOME, SO THIS
PRODUCT, I THINK REALLY FILLS
THAT GAP.
>> YEAH THERE WAS NO VAGINAL
IRRITATION, THERE WAS NO
ITCHING, THERE WAS NO, SMELL,
THERE WAS NO NEGATIVE SIDE
EFFECTS AND YOU DIDN'T AFTER THE
ACTUAL HAVING SEX, THERE WAS
EVEN THROUGHOUT MY DAY
AFTERWARDS THERE WAS NO ISSUES
IN REGARDS TO MY VAGINAL--MY
VAGINA AT ALL.
SO THAT WAS REALLY NICE, THE
NICE PARTS ABOUT IT IS THAT
THERE WERE NO ISSUES OR SIDE
EFFECTS AFTERWARDS.
>> AWESOME, OKAY, GOOD AND YOU
WERE MENTIONING THAT WE TOLD
PEOPLE TO PUT IT IN 30 MINUTES
BEFORE SEX, THE VAGINAL
CONTRACEPTIVE FILMS THAT ARE
OVER THE COUNTER THEY SAY 15
MINUTES SO ACTUALLY THAT IS 1
THING, A COUPLE OF PEOPLE SAID,
YOU KNOW MAYBE THE 30 MINUTES IS
A LITTLE BIT TOO LONG, SO MAYBE
YOU WILL LOOK AT DISSOLUTION AT
15 MINUTES AND 30 MINUTES, SO,
YOU KNOW HOPEFULLY, PEOPLE DON'T
HAVE TO WAIT AS LONG.
>> YEAH.
>> AND THE--BUT WE WILL SEE HOW
LONG IT STAYS IN YOUR SYSTEM,
YOU KNOW SO LIKE, LET'S SAY YOU
PUT IT IN, YOU KNOW BEFORE YOU
WENT OUT IF YOU'RE LIKE A SINGLE
PERSON, YOU KNOW PUT IT IN
BEFORE YOU GO OUT ON A DATE, IS
IT GOING TO BE AROUND, YOU KNOW,
4 OR 8 HOURS LATER.
>> THAT WOULD BE REALLY NICE.
>> SO JUST MAKING SURE THESE
PRODUCTS JIVE WITH PEOPLE'S LIVE
STYLE SYSTEM SUPER IMPORTANT.
>> YEAH, IF IF WE CAN FIGURE OUT
HOW LONG, LIKE YOU SAY IF A
GIRL'S GOING TO PUT IT IN BEFORE
A DATE AND A DATE USUALLY LASTS
234 HOURS AND IS IT STILL GOING
TO BE EFFECTIVE, THAT PART WOULD
BE REALLY COOL BECAUSE THEN THAT
WOULD REALLY, REALLY FULFILL THE
GAP, I FEEL LIKE INSTEAD OF
HAVING TO DO IT 15-20 MINUTES
PRIOR TO AND THEN IT'S LIKE, OH,
DARN IT, I FORGOT, IS IT THIS
GOING TO WORK?
YOU COULD DO IT EARLIER ON IN
THE NIGHT AND NO THAT IT'S STILL
GOING TO BE EFFECTIVE.
>> AND YOU KNOW YOU HAD TO COME
IN THE DAY AFTER YOU GUYS HAD
SEX, AND SO, WE ACTUALLY, WE GOT
SOME SWABS, 1 OF THOSE SAMPLES
WAS TO SEE, OKAY, TWOWRP HOURS
AFTER, IS THERE STILL SOME
ANTIBODY IN THERE, SO YOU KNOW
AND THEN IN THE FUTURE PLANNED
STUDIES WE WILL TEST MAYBE 4
HOURS AFTER YOU PUT IT IN OR 8
HOURS, YOU KNOW AND THEN 24
HOURS.
SO YEAH, REALLY SEEING, YOU KNOW
HOW THIS CAN BE DOSED TO FIT
INTO PEOPLE'S LIFESTYLES NTHAT
WOULD BE GREAT.
>> YEAH, YEAH.
WELL, DO YOU HAVE ANY OTHER
THINGS THAT I HAVEN'T ASKED YOU
OR DO YOU THINK PEOPLE MIGHT
WANT TO KNOW?
>> NO, I THINK THE PRODUCT
ITSELF WAS REALLY GOOD AND IF
YOU CAN FIGURE OUT THE TIME
SPECTRUM ON IT, I WOULD BE
REALLY AWESOME.
IN REGARDS TO JUST DOING
RESEARCH TRIALS, I THINK--I HAD
SO MUCH FUN AGAIN, I AM THINKING
ABOUT SIGNING UP FOR ANOTHER 1.
>> I THINK THE NICE THING IS WE
DO HAVE FUN WITH THE PATIENTS.
>> JUDGES NAND YOU KNOW THIS
SHOULD BE A POSITIVE EXPERIENCE.
YOU KNOW WE'RE NOT TREATING AN
ILLNESS, WE'RE EXPLORING
SCIENCE, DEVELOPING PRODUCTS AND
I THINK IT'S--YOU KNOW I THINK A
LOT OF WOMEN WANT TO SUPPORT
SUPPORT WOMEN'S HEALTH AND
FUTURE OPTIONS FOR WOMEN.
>> THIS ACTUALLY ALSO GIVE ME A
VERY GOOD OPPORTUNITY IN ORDER
TO--I THINK AS PEOPLE ESPECIALLY
WOMEN, EVERYTHING'S SUPPOSED TO
BE PERFECT ESPECIALLY WHEN IT AM
CANS TO OUR BODIES AND VAGINA
AND EVERYTHING IS THIS IS A GOOD
OPPORTUNITY TO BE LIKE LET'S GET
DOWN AND DIRT EXPE FRANK ABOUT
EVERYTHING, SO I HAVE QUESTION,
WHAT ABOUT THIS, OR YOU KNOW,
WHAT DOES THAT MEAN ABOUT THAT
SO IT WAS REALLY NICE TO BE IN
SURCH A GOOD POSITIVE
ENVIRONMENT WITH SO MANY FEMALES
THAT YOU CAN FEEL OPEN TO ASK
THOSE QUESTIONS.
>> OH, YEAH, FOR SURE.
YEAH.
>> COOL, ARE WELL WE REALLY
APPRECIATE YOUR PARTICIPATION
AND WE WILL FIELD QUESTIONS FROM
THE AUDIENCE BUT YEAH, I THINK
IT'S IMPORTANT FOR RESEARCHERS
OUT THERE TO MEET PARTICIPANTS
AND SEE WHAT THEY'RE EXPERIENCE
IS SO I THANK EVERYONE FOR YOUR
TIME AND THANK YOU IF ARE YOUR
TIME.
>> NOT A PROBLEM.
>> ALL RIGHT.
LET ME SEE HOW TO TURN THIS
THING OFF.
>> OKAY, ANNIE, YOU'RE STILL
WITH US.
>> YES.
>> THAT WAS A TAWR DEFORCE AND
WE NEED TO THINK MRS. WRIGHT.
>> I APOLOGIZE IN THE SCRIPT IT
SAYS W-H-I-T-E.
>> OH, OKAY.
>> I WANT TO GET THE SPELLING
CORRECT FOR THE TRANSCRIPTION,
TRANSCRIPT, RATHER.
THIS WAS AMAZING, YOU WERE A
GREAT INTERVIEWER AND SHE CHES
TERRIFIC IN BEING WILLING TO
SHARE VERY PERSONAL ASPECTS OF
HER LIFE.
IN THE CHAT BOX REBEKAH SAYS
THANK YOU FOR GIVES US SUCH A
GREAT FRONT SEAT TO YOUR
IMPORTANT WORK.
I WOULD SECOND THAT I DON'T KNOW
IF ANYBODY ELSE HAS COMMENTS BUT
I WAS IMPRESSED BY HOW
ALTRUISTIC MRS. WRIGHT WAS.
SHE HAS NOTHING TO BENEFIT,
NOTHING TO GAIN FROM THE STUDY,
NO BENEFITS FOR HER MPLET AND
YET, SHE'S SO WILLING TO
PARTICIPATE AND SHE DID GET
BENEFITS SO SHE SAID AT THE END
SHE GOT SOME INFORMATION ABOUT
HER OWN BODY YOU KNOW MAYBE HAD
THE OPPORTUNITY TO ASK QUESTIONS
THAT WOULDN'T COME UP IN A
REGULAR OBGYN VISIT BUT STILL,
THIS APPEARS TO BE A STUDY THAT
REQUIRES SIGNIFICANT AMOUNT OF
INVESTMENT FROM BOTH THE MALE
AND FEMALE PARTNER.
>> SO, QUESTIONS, COMMENTS?
>> I BELIEVE MEMBERS OF ZAB,
BIOARE ON THE ZOOM LINE SO COULD
ALSO FIELD IF YOU HAVE QUESTIONS
ABOUT THE REGULATORY, BUT HOW
SAFE IS THE CONTRACEPTIVE?
WILL THERE ANY--SO THERE'S A
QUESTION IN THE CHAT ABOUT HOW
SAFE IS THE CONTRACEPTIVE FOR
MALE PARTNERS THAT PARTICIPATE
IN ORAL SEX, WE DID HAVE 1 MALE
SAY THAT YOU KNOW HE DIDN'T FEEL
COMFORT FORTABLE PERFORMING ORAL
SEX BECAUSE HE KNEW HIS PARTNER
HAD THE PRODUCT IN, A LOT OF
TIMES THEY WILL DO A PETRESSABLE
NILE MALE TOLERANCE STUDY WITH
VAGINAL PRODUCTS, I WOULD HAVE
TO DEFER TO MY COLLEAGUES ABOUT
IF THERE'S ANY TYPE OF TOLERANCE
STUDY FOR ORAL SEX, BUT I DON'T
THINK IT WOULD BE AN ISSUE, YOU
KNOW, IT DEFINITELY, WHEN THE
FILM DISSOLVES, YOU KNOW IT
WOULD DISSOLVE INTO MAYBE A
COUPLE OF MILLI LITERS SO I
DON'T THINK THAT MEN SHOULD, YOU
KNOW HAVE ANY PROBLEMS WITH
THAT, BUT WE DID HAVE A MALE
PARTNER ASK ABOUT THAT.
WE DIDN'T GIVE THEM SPECIFIC
INSTRUCTIONS TO NOT PERFORM ORAL
SEX AND THAT DID COME UP AND I
DON'T HAVE AN EXACT ANSWER FOR
FUTURE DEVELOPMENT.
I DON'T KNOW IF MARSHAL OR ANY
OF THE OTHER PEOPLE IN ZAB ARE
ON THE CALL.
>> I ALSO HAVE A QUESTION ABOUT
THE MECHANISM BECAUSE YOU KNOW
WOULD THIS BE CONTRA
INTERNATIONAL
CLASSIFICATIONICATED IN WOMEN
WHO DO NOT HAVE A FUNCTIONING
IMMUNE SYSTEM OR WHO HAVE SOME
PROBLEM WITH THEIR IMMUNE
SYSTEM?
>> I'M GOING TO SEE IF ANY OF MY
COLLEAGUES ARE ON THE CALL?
>> HI, I'M HERE.
>> AWESOME, OKAY.
>> MARSHAL'S HERE,.
>> THANK YOU MARSHAL.
>> HI, EVERYONE.
WAS THERE A QUESTION THAT I CAN
ANSWER IN PARTICULAR?
>> I'M SORRY I JUST--
>> HI I'M DR. DIANEA BIANCHI,
I'M THE DIRECTOR OF THE NICHD
AND I ASKED A QUESTION ABOUT THE
MECHANISM, MONOCLONAL ANTIBODY
DOES IT REQUIRE THAT THE FEMALE
PARTICIPANT HAS A FULLY
FUNCTIONAL IMMUNE SYSTEM?
LIKE WOULD IT BE CONTRA INDICATE
INDEED SOMEONE WHO HAS AN
ABNORMALITY IN THEIR IMMUNE
SYSTEM.
>> IT DOES NOT THAT WE KNOW OF.
YOU KNOW AND I THINK THAT'S 1 OF
THE QUESTIONS THAT STILL REMAINS
TO BE ANSWERED WITH REPEATED USE
OF THE PRODUCT BUT, FOR
INSTANCE, YOU KNOW WE HAVE DONE
SOME RESEARCH AND YOU KNOW
THERE'S BEEN SOME EVIDENCE TO
SUGGEST THAT THIS--THE OANT GOOD
BODIES WORK WITHOUT ANY
COMPLIMENTARY IMMUNE FUNCTIONS
WHICH YOU WOULD CLASSICALLY
ASSOCIATE WITH ANTIBODIES,
THINGS THAT HAVE TO DO WITH
IMMUNE EFFECTOR CELLS SO I DON'T
THINK THAT THAT IS NECESSARILY
THE MECHANISM OF ACTION OF THIS
ANTIBODY, IT APPEARS TO REALLY
JUST BE IMMOBILIZATION AND
TRAPPING OF THE ANTIBODY, OR OF
THE SPERM IN THE KIND OF MUCUS
GLYCOLAX, SO THAT'S WAWE KNOW SO
FAR.
>> GREAT.
THAT'S HELPFUL.
THANK YOU.
>> AND I THINK TO ADD TO
MARSHAL, WE WANT THIS TO BE A
TRANSIENT ANTIBODY, EXPOSE IRB
SO THEY GO AWAY WITHIN 24 HOURS
SO THAT THE PATIENT DOESN'T HAVE
TO BUILD UP HER OWN AND WE DON'T
WANT HER BELLING UP LASTING
ANTISPERM ANTIBODIES.
SO YEAH.
>> YEAH THAT'S RECTIFIED
CORRECT.
>> THERE A PASSIVE IMMUNIZATION
MECHANISM.
>> YEAH, RIGHT, VERY MUCH NORMAL
TURNOVER OF ANTIBODIES IN
MUCOSAL SURFACES AND I THINK
THAT OUR, YOU KNOW OTHER
COLLABORATORS TOM AND KEVIN HAVE
DONE A LOT OF WORK ON THIS TO
DEMONSTRATE THAT THAT REALLY
ANTIBODIES ARE A NORMAL PART OF
ANY KIND OF MUCOSAL ENVIRONMENT.
>> GREAT.
I DON'T KNOW ANY JAN JOHNSTON
WANTS TO MAKE ANY FINAL COMMENTS
BUT WE WILL WRAP UP BUT I SIN
LEERILY THANK YOU DR. THURMAN,
AND GIVE OUR SEN ILLEGALSEN SEER
THANKS TO MRS. WRIGHT FOR BEING
SO OPEN AND BEING WILLING TO GO
ON VIDEO TO EDUCATE US ABOUT THE
STUDY.
SO DAN?
>> SORRY ABOUT THAT I WANT TO
THANK YOU FOR COMING ON TOED AND
GIVING AN EXCELLENT PRESENTATION
AND I HOPE COUNCIL MEMBERS WILL
GIVE MORE PERSPECTIVE ON THE
WORK THAT THE BRANCH IS DOING TO
DEVELOP INNOVATE AND I HAVE NEW
CONTRACEPTIVES FOR WOMEN, THAT'S
ALL AND THANKS AGAIN TO
DR. THURMAN.
>> OKAY,.
>> MY PLEASURE, GREAT, THANK
YOU.
>> THANK YOU VERY MUCH, GIVE MY
BEST TO YOUR CHAIR,
DR. [INDISCERNIBLE], AND THIS IS
GOING TO CONCLUDE THE FIRST DAY
OF OUR ZOOM MARATHON OUR 2 DAY
NICHD ADVISORY COUNCIL MEETING,
I HOPE EVERYBODY GETS A GOOD
NIGHT'S SLEEP AND THANK YOU FOR
ATTENDING AND WE LOOK FORWARD TO
SEEING EVERYONE TOMORROW.
THE START TIME WILL BE THE SAME
AS IT WAS TODAY.
NOW WHAT'S A LITTLE BIT
DIFFERENT TOMORROW IS THE FIRST
HOUR AND A QUARTER WILL STILL BE
OPEN SESSION, SO IF THERE ARE
PEOPLE LISTENING--OH, SORRY.
I GUESS ALFRED HAS BEEN
PROMOTED, I DIDN'T KNOW THAT
HE'S NOW PRESIDENT OF THE
UNIVERSITY, CONGRATTULESS TO HIM
THAT MUST BE LATE BREAKING NEWS.
DID EMPLOY NIT WAS A COUPLE
MONTHS AGO, YEAH, HE'S THE
PRESIDENT AND PROVOST OF EVMS
NOW.
>> WOW.
EXCELLENT, WELL PLEASE GIVE HIM
OUR BEST REGARDS.
>> SO TOMORROW FOR THE FIRST
HOUR AND A QUARTER IT WILL STILL
BE OPEN SESSION BECAUSE WE HAD
SO MANY THINGS WE WANTED TO TALK
ABOUT WITH YOU AND THOSE WHO ARE
PARTICULARLY INTERESTED IN
CLINICAL TRIAL NETWORKS, DOCTOR
BOB TAMBURRO WILL GIVE A
PRESENTATION THEN WE'LL GO TO
CONCEPT CLEARANCE AND AFTER THAT
IT WILL BE THE CLOSED SESSION.
SO LIKE I SAID, GET A GOOD
NIGHT'S SLEEP, WE APPRECIATE
YOUR TEABDANCE YOUR ENGAGEMENT,
YOUR QUESTIONS YOUR FEEDBACK AND
WE WILL SEE TOMORROW AT NOON
EASTERN DAY LIGHT TIME.
TAKE CARE EVERYBODY.
KD--SALLY