ASK THAT YOU
RYE MAIN MUTED WHEN YOU'RE NOT
SPEAKING, ACTIVELY SPEAKING,
PLEASE NOTE THAT THE HOST OF THE
MEETING HAS THE ABILITY TO
CONTROL YOUR MICS.
THEY CAN TURN YOU OFF IF YOU
FORGET TO DO SO.
ALSO LIKE AT OUR LAST MEETING WE
ASK THAT YOU TURN YOUR VIDEOS ON
THROUGHOUT THE MEETING, EVEN IF
YOU DON'T SPEAK, WE LIKE TO SEE
YOU.
IF YOU'D LIKE TO MAKE A COMMENT
OR ASK A QUESTION USE THE "RAISE
HAND" FEATURE OR ENTER YOUR
COMMENT OR QUESTION, DIRECTLY
INTO THE CHAT BOX.
ONE OF US WILL CALL ON YOU TO
UNMUTE YOUR MICROPHONE IN THE
ORDER THAT YOU RECEIVED THE
HANDS RAISED FOR THE COMMENTS.
NEXT WE'LL DO THE ROLL CALL OR
INTRODUCTIONS.
I WILL ASK COUNCIL MEMBERS TO
INTRODUCE THEMSELVES, TELLING US
YOUR NAME, INSTITUTIONAL
AFFILIATION, INDICATE IF YOU
HAVE SERVED OR ARE SERVING ON
NIH INSTITUTE OR CENTER ADVISORY
COUNCIL.
AND ON WHICH ONE.
I WILL CALL YOUR NAMES IN
ALPHABETICAL ORDER, INTRODUCE
YOURSELF.
I'LL START WITH DR. CHRISTINE
ARDLEY.
>> I'M BEEN ON THE COUNCIL FOR
FOUR YEARS NOW, I'M COMING TO
THE END OF MY TENURE, I DO NOT
SERVE ON ANY OTHER COUNCILS.
>> THANK YOU.
DR. LINDA CHANG.
>> HI, I HAVE BEEN ON COUNCIL
FOR FIVE YEARS, I THINK THIS IS
ALSO MY LAST YEAR.
SO, I AM A PROFESSOR IN
DEPARTMENT OF RADIOLOGY AND
NEUROLOGY AT UNIVERSITY OF
MARYLAND, BALTIMORE, ALSO JOINT
APPOINTMENT AT JOHNS HOPKINS
BECAUSE OF OUR CLOSE
COLLABORATIONS, AND I HAVE
SERVED ON BOTH NIDA BOARD OF
SCIENTIFIC COUNSELORS AND NIDA
COUNCIL IN THE PAST.
THANK YOU.
>> THANK YOU, LINDA.
DR. GRAHAM COLDITZ.
>> GOOD MORNING, PROFESSOR AT
WASHINGTON UNIVERSITY, SCHOOL OF
MEDICINE, ASSOCIATE DIRECTOR FOR
PREVENTION AND CONTROL AT
SITEMAN CANCER CENTER, ON THE
BOARD OF SCIENTIFIC ADVISORS, MY
LAST YEAR TOO.
>> THANK YOU, GRAHAM.
DR. MONICA GANDHI.
>> I'M MONICA GANDHI, PROFESSOR
OF MEDICINE, IN THE DIVISION OF
INFECTIOUS DISEASE AND HIV AT
UCSF, I HAVE SERVED ON THE
ADVISORY COUNCIL, RECENTLY THAT
TERM ENDED, I'M EXCITED ABOUT
THIS ROLE ON COUNCIL OF
COUNCILS.
>> THANK YOU.
DR. RAFAEL IRIZARRY.
>> CHAIR OF DEPARTMENT OF DATA
SCIENCE, DANA-FARBER CANCER
INSTITUTE, HARVARD BIOSTATISTICS
DEPARTMENT, THIS IS MY FIRST
YEAR IN THIS COUNCIL, AND I HAVE
SERVED IN NHGRI COUNCIL.
>> THANK YOU.
DR. KEVIN JOHNSON.
I THINK KEVIN HAD TO STEP AWAY,
IF I GET THAT RIGHT.
OKAY.
DR. KAREN JOHNSTON.
>> HI, CARE JOHNSTON, I'M A
PROFESSOR OF NEUROLOGY AT THE
UNIVERSITY OF VIRGINIA, AND I
HAVE PREVIOUSLY SERVED ON THE
NINDS COUNCIL.
>> THANK YOU, KAREN.
I WAS ONE HEAD.
MS. BARBARA KELLEY.
>> I'M EXECUTIVE DIRECTOR OF THE
HEARING LOSS ASSOCIATION OF
AMERICA IN THE D.C. AREA, THIS
IS MY FIRST YEAR ON THE COUNCIL
AND I PREVIOUSLY SERVED ON
NATIONAL INSTITUTE OF DEAFNESS
AND OTHER COMMUNICATION
DISORDERS AT NIH.
>> THANK YOU, BARBARA.
DR. JEAN KING.
>> JEAN KING, DEAN OF ARTS AND
SCIENCES, WORCESTER POLYTECHNIC
INSTITUTE, AFFILIATE PROFESSOR
OF RADIOLOGY, NEUROLOGY,
PSYCHIATRY, AT UMass MEDICAL
SCHOOL, STUDY IMPACT OF STRESS
AND RESILIENCE, USING DIFFERENT
METHODS INCLUDING MRI.
I HAVE SERVED ON NCCIH AND
GRATEFUL TO BE SERVING WITH YOU
NOW.
>> THANK YOU, JEAN.
DR. MICHAEL KOTLIKOFF.
>> HI, PROFESSOR AND PROVOST AT
CORNELL, ON MY FIRST YEAR ON
COUNCIL AND I PREVIOUSLY SERVED
ON AND CHAIRED THE BOARD OF
SCIENTIFIC COUNSELORS FOR THE
NHLBI.
>> THANK YOU, MIKE.
DR. DICK KRUGMAN.
>> DISTINGUISHED PROFESSOR OF
PEDIATRICS, UNIVERSITY OF
COLORADO SCHOOL OF MEDICINE, NOT
VICE CHANCELLOR FOR HEALTH
AFFAIRS AS THE ROSTER SAYS, I
DID THAT TEN YEARS AGO.
AND IT'S MY -- THE END OF MY
EITHER FOURTH OR FIFTH YEAR ON
THE COUNCIL, HARD TO KEEP TRACK.
I WAS PREVIOUSLY ON THE NICHD
COUNCIL.
>> WE'LL MAKE A NOTE AND MAKE
THAT CHANGE.
>> THANKS.
>> DR. KENT LLOYD.
>> GOOD MORNING, PROFESSOR OF
SURGERY, SCHOOL OF MED SIB,
CANCER CENTER, RETURNING MEMBER
TO THIS COUNCIL OF COUNCILS.
>> THANK YOU, KENT.
THANK YOU FOR YOUR SERVICE.
EVERYBODY, OF COURSE.
DR. JENNIFER MANLY.
>> HELLO, I'M A PROFESSOR AT
COLUMBIA UNIVERSITY, DEPARTMENT
OF NEUROLOGY, NEUROPSYCHOLOGIST,
AND I HAVE BEEN ROTATING OFF OF
THE AGING COUNCIL FOR QUITE SOME
TIME NOW, BECAUSE THEY ARE
WORKING ON REPLACING THE OLD
COUNCIL MEMBERS, WITH THE NEW
ONES, BUT I'M HAPPY TO BE HERE.
>> THANK YOU, JENNIFER.
DR. RHONDA ROBINSON-BEALE.
>> PLEASE UNMUTE YOURSELF AND GO
AHEAD.
>> ALL RIGHT.
I WONDER IF WE HAVE VIDEO ISSUES
OR AUDIO ISSUES.
CAN YOU HELP, CHRISTINA?
>> DR. ROBINSON-BEALE, CAN YOU
HEAR US?
>> WHY █DON'T WE TRY HER AT THE
END AGAIN.
LET'S SEE IF THAT CAN BE FIXED
OFFLINE.
NEXT I HAVE DR. SUSAN SANCHEZ.
>> GOOD MORNING, EVERYONE.
SUSAN SANCHEZ, PROFESSOR OF
INFECTIOUS DISEASES, COLLEGE OF
VETERINARY MEDICINE, UNIVERSITY
OF GEORGIA, I'VE BEEN I THINK
FIVE YEARS ON COUNCIL, HAVE NOT
SERVED IN ANY OTHER COUNCILS AT
NIH.
THANK YOU.
>> THANK YOU, SUSAN.
MS. LAUREN SILVIS.
>> LAUREN SILVIS, SENIOR
INVOLVED OF EXTERNAL AFFAIRS
TEMPUS, NOT SERVED ON ANOTHER
NIH COUNCIL, IN MY FIRST YEAR ON
THE COUNCIL.
THANK YOU.
>> THANK YOU.
CHRISTINE, HOW ARE WE DOING WITH
DR. ROBINSON-BEALE?
AUDIO PROBLEMS?
SO I THINK I'M GOING BACK TO
WHAT ELSE I NEED TO SAY AFTER
THE ROLL CALL.
WE'LL TAKE IT FROM THERE.
I DO HAVE A COUPLE MORE
ANNOUNCEMENTS.
THE MEETING MATERIALS FOR THIS
ROUND FOR THIS MAY COUNCIL HAVE
BEEN SENT TO YOU IN
COMMUNICATION THAT CAME FROM DR.
SCHWETZ ON MAY 16.
AND THAT ALWAYS ALERTS YOU TO
THE INFORMATION THAT YOU CAN
ACCESS AND THAT WE WILL BE
DISCUSSING.
AS MEMBERS OF THIS COUNCIL, YOU
ARE SPECIAL GOVERNMENT
EMPLOYEES, AND YOU'RE THEREFORE
SUBJECT TO RULES OF CONDUCT THAT
APPLY TO FEDERAL EMPLOYEES.
THESE RULES AND REGULATIONS ARE
EXPLAINED IN THE REPORT,
STANDARDS OF ETHICAL EMPLOYEES
FOR EMPLOYEES OF THE EXECUTIVE
BRANCH, WHICH YOU RECEIVED WHEN
YOU WERE FIRST APPOINTED TO THE
COUNCIL.
AT EVERY MEETING IN ADDITION TO
REMINDING YOU ABOUT THE
IMPORTANCE OF FOLLOWING ETHICS
RULES WE ALWAYS LIKE TO REVIEW
THE STEPS THAT WE TAKE AND ASK
YOU TO TAKE TO ENSURE ANY
CONFLICT OF INTEREST BETWEEN
YOUR PUBLIC RESPONSIBILITIES AND
YOUR PRIVATE INTERESTS AND
ACTIVITIES ARE IDENTIFIED AND
ADDRESSED.
THEREFORE, THREE TIMES A YEAR
YOU PROVIDE US WITH INFORMATION
ABOUT YOUR PERSONAL,
PROFESSIONAL, AND FINANCIAL
INTERESTS, WE USE THIS
INFORMATION AS BASIS FOR
ASSESSING WHETHER YOU ARE -- YOU
HAVE ANY REAL POTENTIAL OR
APPARENT CONFLICT OF INTEREST
THAT COULD COMPROMISE YOUR
ABILITY TO BE OBJECTIVE IN
GIVING ADVICE DURING THE COUNCIL
MEETINGS.
IF SUCH CONFLICTS ARE
IDENTIFIED, WE EITHER ISSUE A
WAIVER OR RECUSE YOU FROM A
PARTICULAR PORTION OF THE
MEETING.
WE ALSO RELY TO A GREAT DEGREE
ON YOU TO BE ATTENTIVE DURING
OUR MEETINGS TO THE POSSIBILITY
IF ANY ISSUE ARISES THAT COULD
AFFECT OR APPEAR TO AFFECT YOUR
INTERESTS IN ANY SPECIFIC WAY,
IF THAT HAPPENS WE ASK YOU TO
RECUSE YOURSELF FROM THE
DISCUSSION, PLEASE NOTIFY US BY
USING THE CHAT FEATURE AND THE
HOST WILL MOVE YOU TO A WAITING
ROOM,IF THAT IS NEEDED.
IF YOU HAVE ANY QUESTIONS DURING
THE YEAR OR ANY TIME ABOUT THE
RULES OF CONDUCT OR CONFLICT OF
INTEREST, OUR COMMITTEE
MANAGEMENT SPECIALIST OR I WILL
BE HAPPY TO ADDRESS THEM.
FAITH IS THE ONE WHO USUALLY
CONTACTS YOU ABOUT FORMS YOU
NEED TO FILL OUT WITH THE
CONFLICT OF INTEREST
INFORMATION.
A COUPLE MORE ITEMS.
TIME IS ALLOTTED IN THE AGENDA
FOR DISCUSSION BY COUNCIL
FOLLOWING EACH PRESENTATION.
UNFORTUNATELY THERE IS LIMITED
TIME FOR ANY COMMENTS FROM OTHER
ATTENDEES.
THE PUBLIC IS WELCOME TO SUBMIT
COMMENTS IN WRITING AFTER THE
MEETING, INSTRUCTIONS FOR DOING
SO ARE IN THE FEDERAL REGISTER
NOTICE THAT WAS PUBLISHED FOR
THIS MEETING ON APRIL 22 THIS
YEAR.
AS ALWAYS, APPROVED MINUTES WILL
BE -- OF THIS MEETING OF COURSE
WILL BE POSTED ON THE DPCPSI
WEBSITE FOR THE COUNCIL.
IMPORTANTLY, NEXT MEETINGS, THE
NEXT MEETINGS, THERE'S ONLY ONE
LEFT FOR THIS YEAR.
IT'S SCHEDULED FOR SEPTEMBER 12
AND 13.
I ALREADY MADE THE COMMENT
EARLIER ON THAT IT'S -- WE'RE
PLANNING ON AN IN-PERSON
MEETING.
SO GET READY FOR THAT.
THE MEETING THEREAFTER IS OUR
EARLY IN THE YEAR MEETING, IT'S
SCHEDULED FOR FEBRUARY 6 AND 7.
ARE THERE ANY QUESTIONS AT THIS
POINT FOR ME?
I DO NOT SEE ANY HANDS, ANY
RAISED HANDS OR COMMENTS IN THE
CHAT.
I WITH THAT I HADN'T IT BACK
OVER TO TARA.
>> GREAT, THANKS.
ALL RIGHT.
REMINDER, AGAIN, WE'RE IN OPEN
SESSION AT TODAY'S MEETING.
THAT'S OPEN TO THE PUBLIC
INCLUDING MEMBERS OF THE PRESS.
WE ARE VIDEOCASTING THIS MEETING
SO EVERYONE CAN LISTEN.
LET'S GET THINGS KICKED OFF.
WE HAVE A REALLY GREAT DAY
PLANNED.
I -- WE HAVE THE AGENDA UP, I'LL
RUN THROUGH IT QUICKLY.
I'LL PROVIDE SOME UPDATES HERE
IN A SECOND FROM DPCPSI, BUT
ALSO NIH-WIDE.
AND THEN WE WILL ALSO HAVE A
PRESENTATION FROM DR. DIANA
BIANCHI, DIRECTOR OF THE EUNICE
KENNEDY SHRIVER NATIONAL
INSTITUTE OF CHILD HEALTH AND
HUMAN DEVELOPMENT, PROVIDING A
BIT OF OVERVIEW ON THE FUTURE
VISION FOR NICHD'S STRATEGIC
PRIORITIES.
WE'LL HEAR UPDATES FROM DPCPSI'S
OFFICE OF RESEARCH ON WOMEN'S
HEALTH ON THE WHITE HOUSE
WOMEN'S HEALTH RESEARCH
INITIATIVE, IN PARTICULAR, AND
ON THE OFFICE OF DIETARY
SUPPLEMENTS FROM THEIR NEW
STRATEGIC PLAN THEY ARE PUTTING
OUT.
AND WE DO HAVE TWO CONCEPT
CLEARANCES THAT WE'LL HEAR A BIT
MORE ABOUT TODAY.
AND WE HOPE TO FINISH BY AROUND
3:40, MAYBE EVEN A LITTLE
EARLIER.
WE'LL SEE HOW THINGS GO.
BUT HOPEFULLY WE'LL HAVE SOME
GREAT DISCUSSION ON ALL OF THOSE
TOPICS.
SO, AS YOU ALL KNOW, THE
DIRECTORS OF EACH OF THE DPCPSI
PROGRAM OFFICES SERVE AS
NON-VOTING LIAISONS TO THIS
COUNCIL.
AND THEY ARE LISTED HERE WITH
PHOTOS ON THE SLIDE.
THEY ARE AVAILABLE, MOST OR
THEIR REPRESENTATIVES ARE ON THE
CALL AND AVAILABLE FOR INPUT OR
COMMENTS IF NEEDED, AND AS
APPROPRIATE.
SO FEEL FREE TO ASK QUESTIONS AS
NEAT THE.
ALL RIGHT.
I WANT TO START OUR NIH-WIDE AND
DPCPSI UPDATES BY ANNOUNCING
STAFF CHANGES, WE'LL START AT
THE SORT OF INSTITUTE LEVEL.
WE HAVE A BRAND-NEW I.C.
DIRECTOR WHO JUST STARTED A
MONTH OR SO AGO.
, SHE WAS NAMED THE 13th
DIRECTOR OF THE FOGARTY
INTERNATIONAL CENTER
DR. KATHLEEN NEUZIL, FIRST WOMAN
TO HOLD THE PERMANENT FOGARTY
DIRECTOR POSITION SINCE THE
CENTER'S FOUNDING IN 1968.
AND SO SHE IS GOING TO LEAD
FOGARTY IN ITS MISSION
SUPPORTING AND FACILITATING
GLOBAL HEALTH RESEARCH CONDUCTED
BY U.S.-BASED AND INTERNATIONAL
INVESTIGATORS BUILDING
PARTNERSHIPS ON GLOBAL HEALTH
RESEARCH AND TRAINING THE NEXT
GENERATION OF SCIENTISTS TO
ADDRESS GLOBAL HEALTH NEEDS.
IT'S A REALLY CRITICAL PART OF
FOGARTY'S PORTFOLIO.
AND DR. NEUZIL JOINT FROM
UNIVERSITY OF MARYLAND SCHOOL OF
MEDICINE IN BALTIMORE, EXCITED
TO HAVE HER IN THIS NEW ROLE.
AND THEN ON FEBRUARY 29, DR.
BERTAGNOLLI ANNOUNCED THE
DEPARTURE OF JOSHUA GORDON, HE
JOINT IN AUGUST OF 2016 FROM
COLUMBIA, WHERE HE WAS ASSOCIATE
PROFESSOR OF PSYCHIATRY,
RESEARCH PSYCHIATRIST AT NEW
NEW
YORK STATE.
HE'S GOING BACK TO COLUMBIA AS
CHAIR OF DEPARTMENT OF
PSYCHIATRY, PSYCHIATRIST IN
CHIEF OF THE NEW YORK
PRESBYTERIAN HOSPITAL CAMPUS AT
COLUMBIA AND IS GOING TO RETURN
AS THE DIRECTOR OF NSPI.
SAD TO SEE JOSH GO.
HE'S BEEN A GREAT COLLEAGUE, BUT
WE'RE USHERING IN THIS NEW ERA I
GUESS FOR NIMH AS WE'LL LAUNCH
THE SEARCH FOR THE NEW DIRECTOR
SOON.
IN THE MEANTIME SHOW THE NIMH
DEPUTY DIRECTOR SHELLI AVENEVOLI
IS GOING TO SERVE AS THE ACTING
DIRECTOR.
AND SHE JOINED NIMH BACK IN 2001
AS STAFF SCIENTIST AND HAS
BOUNCED AROUND IN VARIOUS ROLES
AND LED A NUMBER OF KEY NIMH
EFFORTS.
SO THE INSTITUTE WILL BE IN GOOD
HANDS WITH SHELLI WHILE WE SERVE
FOR A NEW PERMANENT DIRECTOR.
ALL RIGHT.
IF WE SHIFT TO SOME CHANGES IN
DPCPSI LEADERSHIP, REALLY
EXCITED TO ANNOUNCE THREE DEPUTY
DIRECTORS, OFFICE OF DEPUTY
DIRECTORS WHO JOINED OVER THE
LAST SEVERAL MONTHS.
WITHIN OFFICE OF DIETARY
SUPPLEMENTS, ODS, DR. STEPHANIE
GEORGE JOINED AS NEW DEPUTY
DIRECTOR, COMES FROM THE
NATIONAL INSTITUTE OF ARTHRITIS
AND MUSCULOSKELETAL AND SKIN
DISEASES, WHERE SHE WAS AN
EPIDEMIOLOGIST AND PROGRAM
DIRECTOR.
AND OVERSAW NIH'S LARGEST
INVESTMENT IN PHYSICAL ACTIVITY
RESEARCH, WHICH WE CALL
MOPORPAC, A COMMON FUND PROGRAM,
SHE HAD THAT CONNECTION TO
DPCPSI AND WAS IN THE OFFICE OF
DISEASE PREVENTION.
SO, REALLY EXCITED TO HAVE HER
BACK IN THAT ROLE.
NOW, IN THE OFFICE OF BEHAVIORAL
AND SOCIAL SCIENCES RESEARCH,
DR. JANINE SIMMONS IS NEW DEPUTY
DIRECTOR THERE.
SHE COMES TO OBSSR BY WAY OF
NATIONAL INSTITUTE OF MENTAL
HEALTH AND NATIONAL INSTITUTE ON
AGING.
SHE WAS AT NIMH, SHE WAS HEAD OF
THE SOCIAL AND EFFECTIVE
NEUROSCIENCE PROGRAM, REALLY
INVOLVED IN THE BRAIN
INITIATIVE'S BRAIN BEHAVIOR
QUANTIFICATION AND SYNCHRONIZE
ACE, AND AT NIA WAS CHIEF OF THE
INDIVIDUAL BEHAVIORAL PROCESSES
BRANCH, HAS HAD A PRETTY
LONGSTANDING RELATIONSHIP WITH
OBSSR, HAS CHAIRED ONE OF THE
WORKING GROUPS THAT OBSSR LEADS.
SO SHE'S NOW OFFICIALLY IN
DPCPSI.
AND THEN FINALLY IN THE OFFICE
OF RESEARCH ON WOMEN'S HEALTH
DR. VIVIAN OTA WANG, YOU'LL HEAR
FROM HER THIS AFTERNOON,
SELECTED TO SERVE AS THE DEPUTY
DIRECTOR OF THAT OFFICE.
SHE WAS PREVIOUSLY THE POLICY
AND COVID LEAD IN OFFICE OF DATA
SCIENCE AND STRATEGY IN DPCPSI,
AND WAS RESPONSIBLE FOR ETHICS,
EQUITY, AND ISSUES RELATED TO
DATA ACCESS AND SHARING POLICY
DEVELOPMENT IMPLEMENTATION, AND
COVID ACTIVITIES.
AND PRIOR TO JOINING NIH SHE
SERVE IN BUSH AND OBAMA
ADMINISTRATIONS, EXECUTIVE
OFFICE OF THE PRESIDENT NATIONAL
SCIENCE AND TECHNOLOGY COUNCIL,
NSTC.
BUT SHE ALSO SERVED AS SENIOR
ADVISER TO THE DIRECTOR AT OBSSR
SO HAS CONNECTIONs TO DPCPSI.
WE'RE GLAD TO KEEP HER IN THE
FOLD SINCE SHE WAS AT ODSS AND
NOW AT ORWH.
SO REALLY EXCITED TO WELCOME ALL
THREE OF THESE WOMEN TO
LEADERSHIP ROLES WITHIN DPCPSI.
OKAY.
WE'RE GOING TO SWITCH GEARS AND
TALK ABOUT THE BUDGET I WANT TO
OFFER A FEW UPDATES, IN GENERAL.
WE'LL START WITH THE BUDGET
SINCE WE HAVE ONE SINCE THE LAST
FULL MEETING IN JANUARY, WE DID
AT THE END OF MARCH GET AN
ACTUAL BUDGET THIS YEAR.
SO, OUR BUDGET OVERALL FOR NIH
IN FISCAL YEAR 24 IS ABOUT $47
BILLION.
OUR TOTAL DPCPSI BUDGET FOR SAME
TIME FRAME FOR THIS YEAR IS
ABOUT $2.1 BILLION.
THAT INCLUDES ECHO AND "ALL OF
US," IN THE PROCESS OF SHIFTING
TO DPCPSI.
NOW, AS PART OF THAT WE HAD SOME
GOOD NEWS IN WHICH ORWH RECEIVED
A SMALL INCREASE OF $2 MILLION,
PROVIDED FOR THE BUILDING
INTERDISCIPLINARY RESEARCH
CAREERS IN WOMEN'S HEALTH OR
BIRCWH PROGRAM TO HELP FUND
FELLOWS AT SOME OF THE EXISTING
SITES THAT THEY SUPPORT THROUGH
THAT EFFORT.
UNFORTUNATELY, THOUGH, WE DID
HAVE A FEW BUDGET CUTS.
WE HAD SOME HAIRCUTS ACROSS THE
BOARD, BUT IN PARTICULAR TWO
THAT ARE WORTH NOTING, FAIRLY
SIGNIFICANT.
THE "ALL OF US" PROGRAM AGAIN
NOT OFFICIALLY TECHNICALLY IN
DPCPSI JUST YET BUT
UNFORTUNATELY THAT PROGRAM WAS
CUT BY ABOUT 34%, THAT IS DUE TO
A REDUCTION, PLANNED REDUCTIONS
IN MANDATORY MONEY THAT "ALL OF
US" HAS BEEN RECEIVING FOR THE
LAST MANY YEARS.
AND THEN ADDITIONALLY THE COMMON
FUND WAS ALSO CUT BY $50
MILLION.
LAST YEAR THEY RECEIVED AN
INCREASE OF $50 MILLION, SO I
GUESS THE ONE POSITIVE WAY TO
LOOK AT THIS IS THAT IT'S FLAT
FROM FY 22.
BUT OF COURSE, YOU KNOW, WE ARE
NAVIGATING ACROSS ALL OF THESE
EFFORTS.
AND THEN SOME CALL-OUTS THAT
WERE INCLUDED IN THE BUDGET
SPECIFICALLY TO DPCPSI BUT
DIDN'T REALLY IMPACT THE OVERALL
BUDGET NUMBERS INCLUDE SOME
LANGUAGE AROUND CONTINUATION OF
THE OFFICE OF NUTRITION RESEARCH
AT THE FISCAL YEAR 23 LEVEL AND
THE "INCLUDE" PROGRAM, FOCUSED
ON SUPPORTING RESEARCH FOR
PEOPLE WITH DOWN SYNDROME THAT
WILL CONTINUE TO RECEIVE NOT
LESS THAN $90 MILLION.
SO THOSE ARE THE SORT OF BUDGET
IMPLICATIONS OF THE FY 24 BUDGET
FOR DPCPSI AND I JUST WANTED TO
MAKE SURE THAT YOU ALL WERE
AWARE.
NEXT SLIDE.
I WANT TO TALK ABOUT EXCITING
SCIENCE THAT WE HAVE COMING UP
AND SOME OTHER ACTIVITIES THAT
WE'RE READY TO ANNOUNCE.
I WANT TO START WITH SOME PRIZE
WINNERS FOR A FEW PRIZES THAT WE
HAVE LAUNCHED.
SO, IN EARLY 2023, THE OFFICE OF
DATA SCIENCE STRATEGY PARTNERED
WITH FEDERATION OF AMERICAN
SOCIETIES FOR EXPERIMENTAL
BIOLOGY, FASEB, TO LAUNCH THE
SECOND ANNUAL DATAWORKS PRIZE TO
HIGHLIGHT EXAMPLES OF INNOVATIVE
DATA SHARING AND REUSE, AND THIS
YEAR 39 TEAMS WITH OVER 215 TEAM
MEMBERS REGISTERED FOR THE
CHALLENGE TO DEMONSTRATE THEIR
ACCOMPLISHMENTS AND WE ANNOUNCED
WINNERS IN FEBRUARY.
SO THE GRAND PRIZE, $100,000,
WAS AWARDED TO A TEAM FROM
LIFESPAN HEALTH FOR CCC 19, THIS
IS A COLLABORATION THAT
COLLECTED AND DISSEMINATED
PROSPECTIVE GRANULAR UNIFORMLY
ORGANIZED INFORMATION ON
PATIENTS WITH CANCER DIAGNOSED
WITH COVID-19 ALSO.
SO, REALLY EXCITED ABOUT THE
WORK THAT ALL OF THOSE TEAMS ARE
DOING.
ALSO IN FEBRUARY, WE ANNOUNCED
FOUR PHASE 2 WINNERS OF THE
NEUROMOD PRIZE.
THIS IS ALMOST $10 MILLION
COMPETITION TO ACCELERATE
DEVELOPMENT OF TARGETED
NEUROMODULATION THERAPIES, AND
THIS NEUROMOD PRIZE IS PART OF
THE SPARK OR STIMULATING
ACTIVITY TO RELIEF CONDITIONS,
ON COMMON FUND PROGRAM.
WITH THIS COMPETITION NIH IS
USING OPEN INNOVATION TO FOSTER
APPROACHES THAT ARE CAPABLE OF
SELECTING -- TARGETING MULTIPLE
ORGANS AND FUNCTIONS WITHOUT
UNINTENDED EFFECTS ON NON-TARGET
ORGANISMS.
EXCUSE ME, ORGANS, NOT
ORGANISMS.
AND THE FOUR WINNERS OF THE
PHASE 2 USED VARIETY OF
APPROACHES TO STIMULATE A RANGE
OF TARGETS, INCLUDING THINGS
LIKE SPINAL AND PELVIC NERVES,
AND DEMONSTRATED POTENTIAL TO
RESTORE FUNCTION AND ADDRESS
DEBILITATING CONDITIONS, SO
REALLY EXCITING WORK THEY ARE
DOING.
AND THEN FINALLY THE LAST
CHALLENGE WE WANTED TO HIGHLIGHT
WAS THE COMMON FUND
COMPLEMENTARY PROGRAM, WHICH
YOU'VE HEARD ABOUT PREVIOUSLY,
BECAUSE THAT RECENTLY ANNOUNCED
THE PRIZE WINNERS OF THE
COMPLEMENTARY CHALLENGE WHICH
WAS A CROWDSOURCING COMPETITION
FOR INNOVATIVE IDEAS ON NEW
APPROACH METHODOLOGY APPROACHES,
NAMS, TO MODEL HUMAN BIOLOGY.
THE 20 PRIZE WINNERS WERE
AWARDED AND THEY ARE GOING TO
SHARE THAT TOTAL PRIZE PURSE OF
A MILLION DOLLARS, EACH TEAM GOT
ABOUT $50,000 FOR THEIR EFFORTS.
AND THE WINNING SOLUTIONS
DEMONSTRATED REALLY
OUT-OF-THE-BOX SOLUTIONS ACROSS
COMPETITION AREAS.
AGAIN, THIS WAS FOCUSED ON
BUILDING OUT THINGS IN SILICO,
IN VITRO, IN CHEMICO, OR THINGS
THAT INTEGRATED MORE, ONE OR
MORE OF THOSE APPROACHES.
SO CONGRATULATIONS TO ALL OF
THOSE PRIZE WINNERS.
REALLY EXCITING STUFF THEY HAVE
GOING ON.
AND CONTINUING WITH THOSE REALLY
INTERESTING AND EXCITING
RESEARCH UPDATES, I WANTED TO
HIGHLIGHT SOME WORK THAT WAS
REALLY SUPPORTED BY THE OFFICE
OF RESEARCH INFRASTRUCTURE
PROGRAMS THAT LEAD GROUND WORK
FOR THIS CLINICAL ADVANCEMENT.
SO RESEARCH THAT WAS CONDUCTED
BY THE NATIONAL SWINE RESOURCE
AND RESEARCH CENTER WAS -- THIS
IS ONE OF THE ORIP-FUNDED
RESOURCE CENTERS, RESULTED IN
SUCCESSFUL PIG-TO-PIG
ALLOTRANSPLANT MODELS, AND
PIG-TO-NON-HUMAN PRIMATE
XENOTRANSPLANT MODELS, SHOWED
THE SOUNDNESS OF THE HEART
TRANSPLANT TECHNOLOGY, IMPORTED
OVER TO HUMANS.
YOU SEE THE PICTURE OF THE CUTE
SMILING KID HERE, OWEN MONROE,
17 DAYS OLD WHEN HE BECAME THE
WORLD'S FIRST PARTIAL HEART
TRANSPLANT RECIPIENT.
THIS REVOLUTIONARY SURGERY WAS
PERFORMED BACK IN APRIL OF 2022,
AND A STUDY THAT WAS PUBLISHED
JUST IN JANUARY A FEW MONTHS AGO
IN JAMA SHOWED MONROE'S VALVES
AND ARTERIES ARE FUNCTIONING
WELL AND GROWING AS EXPECTED,
AND AS A RESULT HE WILL NEED
FEWER SURGERIES AND LESS
IMMUNOSUPPRESSANTS OVER HIS
LIFETIME.
SO THIS IS REALLY EXCITING WORK.
AND WE'VE SEEN, YOU KNOW, KIND
OF THE DEVELOPMENT FROM VERY
BASIC RESEARCH ALL THE WAY TO
NOW HAVING THIS CLINICAL EXAMPLE
AND BEING ABLE TO IMPROVE THE
LIFE OF THIS LITTLE BOY AND MANY
OTHERS DOWN THE ROAD.
SO AS WE GO TO THE NEXT SLIDE, I
ALSO WANT TO HIGHLIGHT TWO
STRATEGIC PLANS THAT WERE
RECENTLY RELEASED FROM TWO OF
THE DPCPSI OFFICES.
THE OFFICE OF DISEASE PREVENTION
RECENTLY RELEASED THEIR 24-28
STRATEGIC PLAN FOR CREATING A
HEALTHIER FUTURE FOR ALL, WHICH
OUTLINES THE GUIDING ACTIVITIES
OF THE OFFICE OVER THE NEXT FIVE
YEARS.
SO ODP OBVIOUSLY DISEASE
PREVENTION, THEY ARE GOING TO
HELP TO MAKE NIH RESEARCH HAVE
MORE OF AN IMMEDIATE IMPACT ON
THE WELL-BEING OF AMERICANS BY
ENCOURAGING GREATER ATTENTION TO
LEADING CAUSES OF DEATH AND
DEVELOPMENT AND TESTING OF
PREVENTIVE INTERVENTIONS.
SO ODP IS CONTRIBUTING TO
BRIDGING THAT GAP BETWEEN
RESEARCH AND REAL WORLD
PRACTICE, WE JUST HEARD AN
EXAMPLE FROM ORIP DOING THAT,
BUT ODP IS GOING TO HELP
UNDERSTAND HOW CONDITIONS AND
SYSTEMS IN WHICH WE'RE BORN, WE
GROW, WE LIVE, WORK, PLAY, AGE,
ALL AFFECT OUR HEALTH.
AND WE'LL HEAR A LITTLE BIT MORE
ABOUT THIS LATER.
AND THEN THE OFFICE OF RESEARCH
ON WOMEN'S HEALTH ALSO RECENTLY
RELEASED THEIR NIH-WIDE
STRATEGIC PLAN FOR RESEARCH ON
THE HEALTH OF WOMEN OVER THE
SAME TIME PERIOD, 24-28.
AND THEY -- THE PLAN OUTLINES
FIVE STRATEGIC GOALS TO SUPPORT
NIH-GUIDED RESEARCH, LIKE
ADVANCING RESEARCH THAT EXAMINES
MULTIPLE FACTORS TO INFLUENCE
HEALTH OF WOMEN AS WELL AS
INTERSECTIONS OF THOSE FACTORS.
SECOND THING IS TO IMPROVE DATA
SCIENCE AND DATA MANAGEMENT
PRACTICES.
THIRD IS TO FOSTER WOMEN
SCIENTIST CAREER DEVELOPMENT AND
PROMOTION.
AND TO PROMOTE SCIENTIFIC
WORKFORCE TRAINING AND
EDUCATION.
THE FOURTH THING TO SUPPORT
BASIC AND TRANSLATIONAL STUDY,
BIOLOGY UNDERLYING SEX
DIFFERENCES AND HOW THAT PLAYS
OUT WITH THE INTERSECTION OF
DISEASE ACROSS THE LIFE COURSE.
AND THEN FINALLY TO ADVANCE
COMMUNITY ENGAGED SCIENCE ACROSS
THE RESEARCH AND PRACTICE
CONTINUUM, AND ENHANCE
DISSEMINATION, IMPLEMENTATION OF
EVIDENCE-BASED SOLUTIONS.
ALL RIGHT.
WE'RE ALSO GOING TO HEAR FROM
OFFICE OF DIETARY SUPPLEMENTS A
LITTLE BIT ABOUT THEIR STRATEGIC
PLAN AS WELL.
OKAY.
IF WE GO TO THE NEXT SLIDE.
ALL RIGHT.
ONE THING WE WANT TO CALL OUT
BECAUSE THIS MADE GOOD MORNING
AMERICA, INVOLVED A COUPLE OF
OUR DIFFERENT OFFICES ACROSS
DPCPSI.
I THINK WE ALL CAN RECOGNIZE AND
APPRECIATE THAT NUTRITION PLAYS
AN AN INTEGRAL RULE IN
DEVELOPMENT AND PREVENTION AND
TREATMENT OF DISEASE BUT THERE'S
NO SUCH THING AS A PERFECT
ONE-FITS-ALL DIET.
WE HAVE A PROGRAM PRECISION
HEALTH, LED BY OFFICE OF
NUTRITION RESEARCH, HELPS TO
BUILD ON RECENT ADVANCES IN
BIOMEDICAL SCIENCE INCLUDING
BRINGING TOGETHER THINGS LIKE
ARTIFICIAL INTELLIGENCE,
MICROBIOME RESEARCH,
INFRASTRUCTURE THAT WE CAN
LEVERAGE AS WELL AS DIVERSE
PARTICIPANT COHORT, THE "ALL OF
US" RESEARCH PROGRAM, BRING ALL
OF THESE THINGS TOGETHER.
AND THE GOAL OF THE NUTRITION
PRECISION HEALTH PROGRAM IS
REALLY TO DEVELOP ALGORITHMS
THAT PREDICT INDIVIDUAL
RESPONSES TO FOOD AND DIETARY
PATTERNS BY STUDYING
INTERACTIONS BETWEEN THINGS LIKE
THE DIET, GENES, PROTEINS,
MICROBIOME, METABOLISM, AND
OTHER FACTORS AND LEVERAGE A.I.
AND ALGORITHMS THAT CAN THEN BE
APPLIED FOR CLINICAL
APPLICATION.
AND AS I MENTIONED, THIS WAS
FEATURED ON A SEGMENT ON MAY 3
ON "GOOD MORNING AMERICA" AND
IT'S WORTH WATCHING IF YOU HAVE
A FEW MINUTES.
IT'S ONLY A COUPLE MINUTES LONG.
BUT THE STORY REALLY GARNERED A
LOT OF ATTENTION AND THAT
COUPLED WITH OUR LOCAL EFFORTS
RESULTED IN OVER 4400 NEW
CONSENTS THROUGH THAT WEEKEND SO
I THINK THAT WAS THE MOST WE GOT
IN THAT SHORT OF A TIME PERIOD,
SO A GREAT OPPORTUNITY TO
INCREASE AWARENESS OF "ALL OF
US" AS A WHOLE BUT IN PARTICULAR
NUTRITION FOR PRECISION HEALTH
PROGRAM.
ALL RIGHT.
AND NEXT SLIDE.
AND A COUPLE WEEKS AGO, TWO
WEEKS AGO, WE CELEBRATED
NATIONAL WOMEN'S HEALTH WEEK.
ORWH WAS PRETTY BUSY WITH A
VARIETY OF ACTIVITIES INCLUDING
HOSTING THE EIGHTH ANNUAL VIVIAN
PINN SYMPOSIUM, ON ENERGY AND
SCIENCE.
THEY ALSO HAD OPTIMIZING
MID-LIFE HEALTH OF WOMEN
ROUNDTABLE, ON FUTURE DIRECTIONS
IN MENOPAUSE RESEARCH.
THEY ANNOUNCED AND SHARED A
VARIETY OF THINGS THAT WEEK
INCLUDING BIENNIAL WORD,
FACTSHEETS ON WOMEN'S HEALTH
RESEARCH THAT WE SUPPORT AT NIH,
THE HEALTH OF WOMEN OF U3
POPULATIONS DATA BOOK, RELEASED
SOME VIDEOS, AND INCLUDE FORGING
INTO THE FUTURE RESEARCH ON THE
HEALTH OF WOMEN AT NIH AND
BEYOND VIDEO.
SO WORTH CHECKING OUT THE ORWH
WEBSITE TO SEE THE VARIOUS
DIFFERENT ACTIVITIES THAT THEY
WORK TO PROMOTE, DURING THE
NATIONAL WOMEN'S HEALTH WEEK.
ALL RIGHT.
AND THEN KIND OF BUILDING ON
SOME OF THOSE EFFORTS, NIH AND
IN PARTICULAR ODP IS LAUNCHING
ITS FIRST-EVER PATHWAYS TO
PREVENTION SERIES ON MENOPAUSE
AND THE MANAGEMENT OF MENOPAUSE.
ODP IS PARTNERING WITH ORWH,
NCI, NHLBI, NIA, NICHD, AND NIMH
IN THIS EFFORT.
AND THE PATHWAYS TO PREVENTION
WORKSHOP IS GOING TO COLLECT
EVIDENCE-BASED INFORMATION
RELEVANT TO MANAGING MENOPAUSAL
SYMPTOMS AND OPTIMIZING HEALTH
IN THAT EARLY POST-MENOPAUSE
PERIOD, TO IDENTIFY WHAT
ADDITIONAL RESEARCH IS NEEDED TO
HELP WOMEN AND HEALTHCARE
PROVIDERS NAVIGATE THAT
TRANSITION, AND PROMOTE
WELL-BEING THROUGHOUT MID-LIFE
AND BEYOND.
SO AT THE END OF ALL OF THIS
WE'LL HOPEFULLY HAVE REALLY
THOROUGH ASSESSMENT OF THE
PORTFOLIO AND RECOMMENDATIONS
FROM AN INDEPENDENT PANEL ON
MOVING FORWARD AND WE'LL HAVE A
WORKSHOP THAT IS GOING TO BE
HELD IN LATE 2025 TO REALLY GO
THROUGH AND DISCUSS THE DETAILS
OF THESE THINGS AND GET TO THOSE
RECOMMENDATIONS.
ALL RIGHT.
AND NEXT SLIDE, YES, SO ON
JANUARY -- EXCUSE ME, APRIL 15
AND 16 WE HOSTED THE NIH
"INCLUDE" MEETING, "INCLUDE"
INVESTIGATORS MEETING ON CAMPUS.
WE HAD MORE THAN 250
RESEARCHERS, INCLUDING 14
TRAINEES, HERE TO DISCUSS THEIR
RESEARCH AND RESEARCH UPDATES TO
HELP BUILD COLLABORATION AND,
YOU KNOW, JUST DISCUSS HOW NIH
CAN HELP ADVANCE DOWN SYNDROME
RESEARCH OVER THE NEXT SEVERAL
YEARS.
AND WE ENDED UP HAVING AN
OVERWHELMING NUMBER OF POSTER
ABSTRACTS, SO MANY SO THAT WE
INCREASED THE NUMBER WE
SUPPORTED SO WE'RE EXCITED ABOUT
THE INTEREST AND TURNOUT.
WE ALSO HAD ALMOST 30 SPEAKERS
COME AND TALK, AND THREE
SELF-ADVOCATES, AND IT WAS
REALLY A GREAT AND FASCINATING
MEETING.
I WAS ABLE TO JOIN FOR PART OF
IT.
WE HAD AN INVITED SPEAKER AND
DOWN SYNDROME RESEARCH ADVOCATE,
DAVID EGAN, WHO I THINK
ENCAPSULATED THE SORT OF OVERALL
MOOD AND TAKEAWAY FROM THE
MEETING WITH THIS QUOTE.
HE SAID BEING HEALTHY IS A GOAL
FOR EVERY PERSON ON THIS EARTH,
INCLUDING INDIVIDUALS WITH DOWN
SYNDROME.
SO, AGAIN, IT WAS REALLY GREAT
AND REALLY AMAZING TO SEE ALL OF
THE ADVANCES THAT HAVE TAKEN
PLACE OVER THE SHORT I GUESS
DURATION OF THIS PROGRAM'S
EXISTENCE.
ALL RIGHT.
AND THEN MY -- GETTING TO THE
END HERE, I WANTED TO MENTION ON
JUNE 6-8 OBSSR IS HOSTING THE
FUTURE OF SCIENTIFIC
CONFERENCING WORKSHOP, WHICH IS
GOING TO BRING TOGETHER DIVERSE
PERSPECTIVES TO EXPLORE
ADVANTAGES, BARRIERS, GAPS, AND
OPPORTUNITIES IN THE FUTURE OF
SCIENTIFIC CONFERENCING FOR THE
BEHAVIORAL AND SOCIAL SCIENCES.
IT'S GOING TO FOCUS ON A VARIETY
OF DIFFERENT AREAS WHICH YOU CAN
SEE ON THE SLIDE, RANGING FROM
TECHNOLOGICAL INNOVATIONS AND
THEIR IMPACT AND ENVIRONMENTAL
SUSTAINABILITY AS WELL.
SO FOR MORE INFORMATION AND TO
REGISTER, YOU CAN GO TO THE
OBSSR WEBSITE AND TAKE A LOOK AT
THAT INFORMATION THERE ON THAT
WORKSHOP.
ALL RIGHT.
AND THEN FINALLY, I WANTED TO
SHARE WITH EVERYONE SOME
INFORMATION ABOUT AN OFFERING WE
HAVE THAT'S A PARTNERSHIP
THROUGH THE NIH CENTER FOR
INFORMATION TECHNOLOGY, AND OUR
DPCPSI OFFICE OF DATA SCIENCE
STRATEGY.
THIS IS THE NIH CLOUD LAB, AND
IT REALLY ENABLES RESEARCHERS TO
TRY OUT THE CLOUD IN A SECURE
AND NIH-APPROVED ENVIRONMENT.
THE CLOUD LAB IS A NO-COST
90-DAY CLOUD ADOPTION PROGRAM
THAT PROVIDES AN ACCOUNT WITH
$500 OF CREDITS FOR AMAZON WEB
SERVICES, GOOGLE CLOUD, OR
MICROSOFT AZURE, AND IT ALSO
PROVIDES ACCESS TO CURATED
BIOINFORMATICS TUTORIALS AND
SUPPORT FROM NIH EXPERTS.
SO IF YOU'RE EITHER A NOVICE OR
AN EXPERT, IT'S AN OPPORTUNITY
TO BE ABLE TO PLAY AROUND A
LITTLE BIT IN A SECURE
ENVIRONMENT AND LEARN AND,
AGAIN, IT COMES WITH THE CREDITS
THAT WE OFFER.
AND IT'S BEEN AVAILABLE
INTERNALLY TO OUR INTRAMURAL
RESEARCHERS AND OUR NIH STAFF
FOR THE LAST COUPLE YEARS.
BUT IT'S NEWLY AVAILABLE TO
RECIPIENTS OF NIH FUNDING AND
RESEARCHERS AT INSTITUTIONS THAT
ARE ELIGIBLE FOR NIH FUNDING
INCLUDING THOSE WHO MAY NOT HAVE
AN ACTIVE AWARD.
YOU CAN DO A BUNCH OF THINGS.
THERE'S INFORMATION HERE THAT
I'M NOT GOING TO GO THROUGH.
IF YOU WANT TO LEARN MORE YOU
CAN VISIT THE CLOUD LAB HOME
PAGE BY SCANNING THE QR CODE YOU
SEE IN THE MIDDLE OF THE SCREEN.
OKAY.
OBVIOUSLY I CAN CONTINUE TALKING
ABOUT ALL OF THE VARIOUS THINGS
THAT WE HAVE ONGOING ACROSS NOT
JUST DPCPSI BUT NIH FOR A VERY
LONG TIME BUT IN ORDER TO KEEP
US ON TIME, I'M GOING TO STOP
NOW SO WE CAN ACTUALLY GET TO
THE REST OF OUR AGENDA.
BUT OBVIOUSLY WE'VE MADE A TON
OF WONDERFUL ADVANCES AND
INVESTMENTS IN VARIOUS PROGRAMS
AND ACTIVITIES ACROSS ALL OF OUR
OFFICES.
THAT WAS JUST A LITTLE UPDATE ON
A FEW OF THOSE.
SO WE'RE GOING TO SHIFT GEARS,
AND I'M GOING TO TURN IT OVER IN
JUST A MINUTE TO GO OVER OUR
FIRST CONCEPT CLEARANCE FOR
TODAY.
THIS IS FROM THE OFFICE OF
STRATEGIC COORDINATION, ALSO
KNOWN - AS COMMON FUND OFFICE.
DR. TIMOTHY LAVAUTE WILL
PRESENT, SCGE.
THE PRESENTATION WILL BE
FOLLOWED BY COMMENTS AND
DISCUSSION FROM TWO OF OUR
ASSIGNED COUNCIL MEMBERS,
DOCTORS KENT LLOYD AND JEAN
KING.
THANK YOU FOR AGREEING TO DO
THAT.
WITH THAT I'M NOW GOING TO TURN
IT OVER TO TIM TO RUN THROUGH
THIS CONCEPT CLEARANCE.
SO, TIM, TAKE IT AWAY.
WE CAN'T HEAR YOU.
WE CAN'T HEAR YOU IN THE ROOM; I
DON'T KNOW IF OTHERS CAN HEAR
HIM.
>> I'M GOING TO JUMP IN.
I LEARNED BEFORE THAT WE CAN'T
UNMUTE YOU.
YOU NEED TO UNMUTE YOURSELF.
I LEARNED THAT WITH THE
INTRODUCTIONS.
>> ZOOM CAN HEAR BUT YOU'RE VERY
QUIET, TIM.
MAYBE IT'S A MATTER OF TURNING
UP YOUR MICROPHONE?
>> HOW ABOUT NOW?
>> PERFECT.
>> OKAY.
WE'LL START WITH TECHNICAL
DIFFICULTY.
GOOD AFTERNOON, I'M TIMOTHY
LAVAUTE, PROGRAM DIRECTOR, ALSO
CO-COORDINATOR OF COMMON FUND
SOMATIC CELL GENOME EDITING,
SCGE, TODAY SEEKING APPROVAL FOR
CONCEPT FOR NEW INITIATIVE OF
LIMITED COMPETITION COMPETITIVE
REVISION, NOTICE OF FUNDING
OPPORTUNITY, FOR ADDING CLINICAL
TRIALS TO EXISTING SCGE THERAPY
DEVELOPMENT AWARD.
THE OBJECTIVE OF THE PROPOSED
CONCEPT IS TO EXPAND THE SCOPE
OF THERAPY DEVELOPMENT AWARDS TO
SUPPORT FIRST-IN-HUMAN OR EARLY
STAGE CLINICAL TRIALS.
THE INITIATIVE WILL REQUIRE UP
TO $6 MILLION TO FUND TWO AWARDS
AND THAT WOULD BE CONTINGENT OF
SUBMISSION OF QUALITY
APPLICATIONS AND AVAILABILITY OF
FUNDING.
NEXT SLIDE PLEASE.
WE'RE SEEKING APPROVAL FOR A
CONCEPT FOR ADDING CLINICAL
TRIALS TO EXISTING THERAPY
DEVELOPMENT AWARDS, OBJECTIVE IS
TO SUPPORT FIRST-IN-HUMAN AND
EARLY-STAGE CLINICAL TRIALS,
REQUIRING UP TO $6 MILLION FOR
FUNDING TWO AWARDS CONTINGENT
UPON SUBMISSION OF QUALITY
APPLICATIONS AND AVAILABILITY OF
FUNDING, WE EXPECT THE PROJECT
PERIOD TO LAST ABOUT TWO YEARS.
NEXT SLIDE PLEASE.
I'D LIKE TO SPEND A MINUTE OR
TWO GIVING AN OVERVIEW.
THE PROGRAM IS IN ITS SECOND
FIVE-YEAR PERIOD, ENTERING ITS
SEVENTH YEAR.
FIRST PHASE WAS FOCUSED ON
GENOME EDITING TECHNOLOGY
DEVELOPMENT.
AND THE SUCCESS OF IT WAS THE
RESULT OF FUNDING A GROUP OF
REALLY TALENTED INVESTIGATORS
AND A WELL-DESIGNED PROGRAM.
WHICH INCORPORATED VALIDATION
AND REPLICATION STUDIES.
IT CONSISTED OF FIVE
INITIATIVES, AND THEY WERE ONE,
FIRST, TO EXPAND REPERTOIRE OF
GENOME EDITORS, REPRESENTED IN
BLUE.
A SECOND TO DEVELOP NEW DELIVERY
METHODS, TO DELIVER GENOME
EDITING, CORRECT TISSUES AND
CELL TYPES, HIGHLIGHTS HERE
WHERE DEVELOPMENT OF HIGHLY
EFFICIENT BLOOD-BRAIN BARRIER
PENETRATING AAV SEROTYPES.
ANOTHER WAS FOCUSED ON ASSAYS TO
DEVELOP -- DETECT ADVERSE
CONSEQUENCES OF GENOME EDITING.
AN INITIATIVE FOR THE SETTING UP
AND STANDING UP LARGE AND SMALL
ANIMAL TESTING CENTERS FOR
DEVELOPING REPORTER ANIMALS,
CONDUCTING REPLICATION STUDIES.
AS MENTIONED, THIS WAS A KEY
FEATURE TO THE SUCCESS OF PHASE
1.
IT'S REPRESENTED BY THE ARROWS
AT THE BOTTOM OF THE DIAGRAM
HERE WHERE NEW EDITORS OR
DELIVERY SYSTEMS WERE TESTED AT
THESE INDEPENDENT LARGE AND
SMALL ANIMAL REPORTING SYSTEMS.
AND THEN BEFORE INFORMATION WAS
DEPOSITED INTO OUR DISSEMINATION
AND COORDINATION CENTERS,
REPLICATION HAD TO BE POSITIVE.
THERE WAS DISSEMINATION AND
COORDINATION CENTER TO
DISTRIBUTE THE FINDINGS FROM
PHASE 1 TO THE GENOME EDITING
COMMUNITY.
AND MANY ACHIEVEMENTS HAVE NOW
BEEN DISSEMINATED AND ADOPTED BY
INVESTIGATORS ACROSS THE FIELD.
AND MANY WERE UTILIZED BY
INVESTIGATORS THAT ENDED UP
BEING FUNDED IN THE SECOND PHASE
OF THE PROGRAM.
NEXT SLIDE PLEASE.
SO IN PHASE 2 THE PROGRAM'S
FOCUS ADVANCED FROM TOOL
DEVELOPMENT TO THERAPY
DEVELOPMENT WITH GOALS BEING
MOVING GENOME EDITING
THERAPEUTICS INTO THE CLINIC.
ALSO ESTABLISHING THROUGH
INTERACTIONS WITH FDA,
ESTABLISHING DEFINED REGULATORY
PATH FOR APPROVAL FOR THERAPIES,
AND FINALLY ALSO ESTABLISHING
GENOME EDITING AS A PLATFORM
THERAPY WITH THE FDA.
AND THAT WOULD BE THAT IF YOU
HAVE SAME TISSUE YOU'RE TRYING
TO ADDRESS A DISEASE, AS YOU'RE
TRYING TO ADDRESS THE SAME
TISSUE, USING THE SAME DELIVERY
SYSTEM, SAME ROUTE OF
ADMINISTRATION AND GENOME
EDITOR, ALL THAT IS CHANGING IS
THE GUIDE RNA TO TELL THE GENOME
EDITOR WHERE TO GO ON THE
GENOME, THAT PERHAPS AS YOU CAME
IN WITH A SECOND VARIANT THE
PATHWAY WOULD BE MUCH SIMPLER.
WE'VE FUNDED AWARDS THROUGH
THESE FOUR INITIATIVES, FIVE
AWARDS FOR DEVELOPMENT OF NEW
ASSAYS FOR MEASURING OFF-TARGET
ASSAYS.
NEXT SLIDE.
WELL, ANYWAY, SO GO BACK ONE
SLIDE.
THESE FIVE INITIATIVES, SO ONE
FOR DEVELOPING ASSAYS TO DETECT
ADVERSE GENOME EDITING EVENTS, A
SECOND ONE, FIVE AWARDS FUNDED
FOR IND-ENABLING PRE-CLINICAL
STUDIES.
THERE'S BEEN ONE PLATFORM
CLINICAL TRIAL HAS BEEN FUNDED.
AND THEN ALSO THERE WAS
CONTINUATION OF DISSEMINATION
AND COORDINATION CENTER.
NEXT SLIDE PLEASE.
THE FIVE IND-ENABLING PROGRAM
PROJECTS WHICH ARE THE FOCUS OF
THIS CONCEPT CLEARANCE ARE
LISTED HERE.
AND EACH OF THESE CONTAINS THREE
DISTINCT PROJECTS FOR THE
DEVELOPMENT OF GENOME EDITING
BASED THERAPEUTIC LEADS.
ONE OF THE PROJECTS IS
IDENTIFIED AS A TRAILBLAZER
POISED TO ADVANCE THERAPEUTIC
CANDIDATE TO IND WITHIN THE
FIVE-YEAR PROJECT PERIOD.
THE OTHERS ARE AT EARLIER STAGE
OF DEVELOPMENTS AND WOULD
PROBABLY -- HOPEFULLY IDENTIFY
CLINICAL CANDIDATE WITHIN THE
PROJECT PERIOD.
THESE ARE SUPPORTED BY
ADMINISTRATIVE CORE AND ONE OR
MORE SCIENTIFIC CORES, MANY
CONTAINING REGULATORY FOR FDA OR
THERAPEUTIC PRODUCTION.
ADVANCING TO CLINICAL TRIALS WAS
NOT PART OF THIS INITIATIVE.
WE JUST DIDN'T ANTICIPATE
INVESTIGATORS PROGRESSING SO
QUICKLY, AND A FEW OF THEM HAVE.
THEY ARE POISED TO HAVE THEIR
INDs EARLIER THAN ANTICIPATED.
NEXT SLIDE PLEASE.
GOALS OF THIS CONCEPT AND
COMPETING REVISION NOFO ARE TO
CAPITALIZE ON SUCCESS OF THE
INVESTIGATORS IN DEVELOPING NEW
GENOME EDITING THERAPIES,
ACTUALLY ANTICIPATED.
TO EXPAND SCOPE OF THEIR AWARDS
TO ALLOW HUMAN SUBJECTS
RESEARCH.
TO USE NIH AND SCG AWARD DOLLARS
EFFICIENTLY BY ALLOWING
INVESTIGATORS TO REBUDGET
EXISTING AWARD AND REDIRECT
THOSE FUNDS TOWARDS CLINICAL
TRIAL READINESS ACTIVITIES.
FINALLY TO SUPPORT
FIRST-IN-HUMAN CLINICAL TRIALS
OF NOVEL GENOME EDITING
THERAPIES.
NEXT SLIDE PLEASE.
ONE THING WE ARE AWARE OF AS
WE'RE DEVELOPING THIS NEW
INITIATIVE IS IMPORTANCE OF
INCLUDING DIVERSE PERSPECTIVES,
HELPING SHAPE THIS NOFO.
THE SCGE WILL REQUIRE APPLICANTS
TO DEVELOP STRATEGIES FOR
ENGAGING WITH VARIOUS
STAKEHOLDERS, DEVELOPING BEST
PRACTICES FOR SHARING MEDICAL
AND RELEVANT INFORMATION ON
RISKS AND BENEFITS OF GENOME
EDITING AND DEVELOPING
STRATEGIES FOR THOUGHTFUL OF
ENGAGEMENT OF MARGINALIZED
POPULATIONS ON THE RISKS AND
BENEFITS OF GENOME EDITING.
FINALLY WE'D LIKE TO MENTION
WHAT WE SEE AS THE POTENTIAL
IMPACT OF THIS NOFO.
FIRST, THERE'S THE IMPACT ON THE
PROGRAM.
IT WILL REPRESENT THE
CULMINATION OF YEARS OF WORK BY
SCGE INVESTIGATORS AND DELIVER
ON ONE OF THE MAJOR GOALS MOVING
GENOME EDITING THERAPIES INTO
THE CLINIC.
THERE'S THE IMPACT ON THE FIELD.
IT WILL PROVIDE EXAMPLE OF
GENOME EDITING THERAPEUTICS
THROUGH REGULATORY PROCESS FROM
PRE-CLINICAL DEVELOPMENT TO IND
AND CLINICAL TRIALS.
THE INFORMATION THAT'S GENERATED
ON THAT REGULATORY PROCESS WILL
BE SHARED THROUGH THE SCGE
CONSORTIUM AND PROVIDE A ROAD
MAP FROM PRE-CLINICAL
DEVELOPMENT TO CLINICAL TRIALS
FOR GENE EDITING THERAPIES.
FINALLY THE IMPACT ON THE
PATIENTS.
SOME OF THESE CASES WILL PROVIDE
HOPE FOR TRUE CURES FOR
DEBILITATING GENETIC DISORDERS
AND DISEASES.
I'LL STOP. THERE I'D LIKE TO
THANK YOU FOR YOUR CONSIDERATION
AND I WOULD BE HAPPY TO ANSWER
ANY QUESTIONS.
>> HELPS TO TURN ON THE MIC
HERE.
GREAT PRESENTATION, TIM.
THANK YOU FOR GOING OVER THIS
CONCEPT.
BEFORE WE OPEN IT UP BROADLY FOR
QUESTIONS, I'M GOING TO TURN IT
TO DR. LLOYD, WHO IS ONE OF THE
DISCUSSANTS.
KENT, IF YOU WOULDN'T MIND
PLEASE SHARING ANY COMMENTS YOU
HAVE, THAT WOULD BE GREAT.
>> HI.
SO THANKS FOR YOUR PRESENTATION.
CAN YOU HEAR ME ALL RIGHT?
>> YES, I CAN.
>> SO I MEAN, THIS IS ONE OF
THOSE PROJECTS THAT'S A POSTER
CHILD FOR -- MAYBE FORGET THE
NAME BUT POSTER CHILD FOR
SUCCESS AT NIH FUNDING.
YOU WANT TO BE ABLE TO SAY
ESPECIALLY UP ON THE HILL WE
INVESTED IN A PROJECT THAT'S
OVERDELIVERED AND BEYOND
EXPECTATIONS, FASTER THAN WE
ANTICIPATED.
SO THOSE ARE THE ONES YOU WANT
TO KEEP IN YOUR BACK POCKET TO
PRESENT WHEN ASKED WHAT'S THE
VALUE OF THE INVESTMENT BY THE
FEDERAL GOVERNMENT TO THE TAX
DOLLARS INTO THE NIH.
CONGRATULATIONS ON THAT.
I'M GOING TO -- NORMALLY I WOULD
GIVE AN OVERVIEW OF THE PROGRAM
AND SO ON BUT I THINK THERE ARE
A FEW COMMENTS I HAVE OR
QUESTIONS REGARDING THE
ORGANIZATION, AND THE PLAN
FOR
ADMINISTERING THIS NON-COMPETING
REVISION PROCESS I'D LIKE TO
FOCUS ON, HOPEFULLY ALL THE
COUNCIL MEMBERS APPRECIATE THE
SOMATIC GENE EDITING PROGRAM,
VALUE AS WAS PRESENTED, SINCE
2018, THE PROGRESS IT'S MADE,
TEN YEAR COMMON FUND.
SO IF I UNDERSTAND CORRECTLY
WE'RE AT 2024, SO IN THE FIRST
YEAR OF PHASE 2, IS THAT
CORRECT?
>> THAT'S CORRECT.
>> ON ONE OF YOUR SLIDES -- AND
THE SECOND THING IS THAT THIS
PROPOSAL IS TO ENABLE THE
CURRENT GRANTEES, IT'S A LIMITED
COMPETITION, SO ENABLE CURRENT
GRANTEES IN THE IND-ENABLING
COMPONENT TO SPEND THEIR MONEY
ON CLINICAL TRIALS.
IS THAT CORRECT?
>> THAT'S CORRECT.
>> OKAY.
BUT I GOT THE IMPRESSION FROM
YOUR PRESENTATION THAT IN
ADDITION TO SPENDING EXISTING
AWARD PLANT AWARD MONEY THERE'S
ADDITIONAL MONEY BEING ADDED,
NEW MONEY BEING ADDED TO THIS
PROGRAM.
HAVE I GOT THAT RIGHT?
>> THAT'S CORRECT.
IT COULD BE THAT THE EXISTING
BUDGETS WOULD NOT BE ENOUGH TO
COVER THE ENTIRE PREPARATION AND
ADMINISTERING OF A CLINICAL
TRIAL.
AND WE WOULD ALLOW PEOPLE TO,
WHEN THEY ARE SUBMITTING
APPLICATIONS, TO RESTRUCTURE
THEIR BUDGET OF CURRENT AWARD
BUT ASK FOR ADDITIONAL DOLLARS
IF THEY ARE NECESSARY.
>> OKAY.
AND IN ONE ONE OF YOUR SLIDES,
NUMBER 4, WERE LISTED THE SCGE
OVERVIEW PHASE 2 THERAPY
DEVELOPMENT, FOUR COMPONENTS,
IND-ENABLING STUDIES WAS SECOND.
THIRD WAS PLATFORM CLINICAL
TRIALS.
SO, DO I UNDERSTAND --
>> THAT'S CORRECT
>> -- THAT THERE ARE FUNDED
CLINICAL TRIALS MECHANISM IN
THIS PHASE 2, WHY THEN IS THERE
A NEED FOR CLINICAL TRIALS FOR
THE IND-ENABLING STUDIES
COMPONENT?
>> RIGHT, SO THEY WERE TWO
STAND-ALONE FUNDING
ANNOUNCEMENTS, ONE FUNDED
IND-ENABLING STUDIES.
THE SECOND ALLOWED FOR CLINICAL
TRIALS TO BE PROPOSED BUT THEY
ARE MUCH LIKE THE IND-ENABLING
STUDIES.
THE INVESTIGATOR THAT WAS
AWARDED DID NOT ACTUALLY POSSESS
AND IND AT THE TIME OF AWARD.
AND STILL DON'T.
WE'RE EXPECTING THEM TO HAVE
THAT AT THE END OF YEAR 2.
AND THEN THEY WOULD MOVE INTO
THE CLINICAL TRIAL ONCE THEY HAD
THE IND IN HAND.
SOME OF OUR U19 IND-ENABLING
STUDY INVESTIGATORS ARE AT THE
SAME STAGE AS THAT INVESTIGATOR,
AND SO WE WOULD LIKE THE
OPPORTUNITY TO PROVIDE THEM --
PROVIDE THEM THE OPPORTUNITY TO
MOVE INTO CLINICAL TRIALS AS
WELL BUT THEY WERE TWO SEPARATE
FUNDING ANNOUNCEMENTS, TO SETS
OF APPLICATIONS AND AWARDS.
>> RIGHT.
SO TO ALLOW THIS FORWARD YOU
NEED TO BRING IT TO COUNCIL
BECAUSE IT'S A BUREAUCRATIC
CHANGE, RIGHT.
SO IS THERE PRECEDENT FOR WHAT
YOU'RE ASKING TO DO IN PROGRAMS
BEFORE OR IS THIS DONE ALL THE
TIME?
>> NOT DONE ALL THE TIME.
BUT IT IS NOT UNIQUE.
THERE HAVE BEEN A COUPLE OF
INSTANCES.
AND ONE OR TWO RECENT ONES
DURING COVID FOR MOVING
THERAPIES THERE FROM SOMETHING
THAT WAS NOT GOING TO BE A
CLINICAL TRIAL INTO A CLINICAL
TRIAL DURING AN EMERGENCY.
THERE ARE EXAMPLES BUT IT'S NOT
DONE VERY FREQUENTLY.
>> TWO LAST QUICK QUESTIONS.
DOES THIS -- BECAUSE THIS IS
PART OF THE COMMON FUND THERE'S
A 10-YEAR LIMIT ON COMMON FUND
PROGRAMS.
WILL THIS THEN MAKE THIS PROGRAM
GO BEYOND THE LIMIT OF 10 YEARS
OR WOULD THIS ALL THEN HAVE TO
BE PACKAGED WITHIN THE FULL 10
YEARS OF THE COMMON FUND
PROGRAM?
>> IT WOULD HAVE TO BE COMPLETED
WITHIN THE 10-YEAR PERIOD.
THERE WOULD BE THE AVAILABILITY
OF A KNOW-COST EXTENSION BUT NO
MORE MONEY PROVIDED.
BUT WE COULD STILL HAVE
ADMINISTRATIVE OVERSIGHT DURING
THE NO-COST EXTENSION.
>> WHAT IS PLAN FOR DIVERSITY OF
PATIENTS INTO CLINICAL TRIALS
SPONSORED BY THIS NEW PROGRAM?
>> RIGHT.
SO, AT OUR KICKOFF MEETING, FOR
PHASE 2, A LARGE COMPONENT WAS A
WORKSHOP ON HEALTH DISPARITIES
AND HEALTH EQUITY, AND
ESPECIALLY AROUND GENE THERAPIES
AND SPECIFICALLY AROUND GENOME
EDITING THERAPIES.
AND INVESTIGATORS PROVIDED MANY
STRATEGIES ABOUT HOW TO
INCORPORATE DIVERSE POPULATIONS
IN FUTURE CLINICAL APPLICATIONS
OF THIS TECHNOLOGY, AND SOME OF
THOSE STRATEGIES ARE HOUSING,
WHERE THE THERAPY WOULD BE
DELIVERED, IN NEIGHBORHOODS THAT
ARE UNDERSERVED.
SO ONE OF THE INVESTIGATORS IS
FROM THE UNIVERSITY OF
PENNSYLVANIA AND CHILDREN'S
HOSPITAL OF PHILADELPHIA.
THEY HAVE ACCESS TO DIVERSE
POPULATIONS THERE.
THAT'S ONE EXAMPLE.
ANOTHER EXAMPLE IS STRATEGIES
FOR IDENTIFYING VARIANTS THAT
AFFECT BROADER POPULATIONS, OR
MAYBE EVEN TARGET UNDERSERVED
POPULATIONS, A VARIANT THAT MAY
BE HIGHER IN A CERTAIN
POPULATION SO THAT YOU COULD
ADDRESS IT IN THAT ACTION AS
WELL.
MANY STRATEGIES WERE TALKED
ABOUT.
S SO -- THOSE WERE SOME, WE
WOULD ENCOURAGE INVESTIGATORS
WHEN THEY COME IN WITH
APPLICATIONS TO ADDRESS HOW THEY
ARE GOING TO MAKE SURE THAT THE
THERAPY IS ABLE TO BE DELIVERED
TO AS BROAD POPULATIONS AS
POSSIBLE.
>> I MIGHT ENCOURAGE, I DON'T
KNOW IF YOU CAN REQUIRE, I THINK
IT NEEDS TO BE A COMPONENT OF
ALL THESE TYPE OF PROJECTS
MOVING FORWARD THERE MUST BE A
PLAN FOR ENHANCING DIVERSITY.
THANKS VERY MUCH.
I'M A LONG FAN OF THE SCGE
PROGRAM, AND I'M STRONGLY,
STRONGLY IN FAVOR OF THE PROGRAM
AS ORIGINALLY WRITTEN AND I'M IN
FAVOR OF YOUR PLAN FOR THIS
LIMITED COMPETITION NOFO FOR
ALLOWING CLINICAL TRIALS.
SO THANKS VERY MUCH.
>> THANK YOU FOR YOUR KIND WORDS
AND WE'LL CERTAINLY INCLUDE
EXACTLY WHAT YOU'VE SAID THERE
AT THE END, THAT WE WOULD
REQUIRE A PLAN FOR DIVERSE
POPULATIONS.
>> THANKS, KENT, FOR YOUR
THOUGHTFUL QUESTIONS AND
SUGGESTIONS.
VERY MUCH WORTH EMPHASIZING.
OKAY.
I'M GOING TO TURN IT OVER TO DR.
KING.
JEAN, IF THERE ARE ADDITIONAL
QUESTIONS OR COMMENTS YOU WOULD
LIKE TO MAKE PLEASE FEEL FREE.
>> NO, I WANT TO THANK YOU BOTH
FOR CLARIFICATIONS AND
PRESENTATIONS.
IT REALLY DID PUT SOME OF THE
PIECES TOGETHER.
I HAD SIMILAR CONCERNS, AFTER
READING THIS I HAVE TO SAY I
TOTALLY LOVE THE IDEA OF
LEVERAGING THE WAY YOU ARE TO
GET THERE FASTER BECAUSE MOST OF
WHAT WE GET STUCK WITH IS GOING
TO THE CLINICAL TRIALS.
AND I LIKE THE IDEA OF NOT ONLY
ARE WE DOING IT BUT THESE
REGULATORY PROCESSES WILL THEN
BE AVAILABLE TO EVERYBODY ELSE
SO THAT THEY CAN FOLLOW IT AND
NOT KEEP CREATING THE WHEEL.
I SEE WE DO A LOT OF THAT.
SO I'M REALLY GRATEFUL FOR YOU
MAKING SURE WE HIGHLIGHT THAT
THESE PROCESSES WILL THEN BE
AVAILABLE TO EVERYBODY IN THAT
FIELD, THAT CAN MOVE US FASTER
TO CLINICAL TRIALS.
I DO WANT TO GO BACK A LITTLE
BIT TO JUST ONE SLIDE BEFORE THE
LAST, WHICH REALLY DOES GO ALONG
WITH DR. LLOYD'S COMMENTS
BECAUSE MOST OF THE PERSPECTIVES
ARE DEVELOPING STRATEGIES, SO
DEVELOPING STRATEGIES TO BETTER
ENGAGE PARTICIPANTS, NEXT ONE
DEVELOPING BEST PRACTICES, AND
THE THIRD ONE WHICH I CONSIDER
SHOULD BE MORE THAN DEVELOPING
BUT DEVELOPING AND IMPLEMENTING
IS THE UNIQUE CONCERNS AND
STRATEGIES TO BE APPLIED IN A
THOUGHTFUL ENGAGEMENT OF
MARGINALIZED POPULATIONS.
SO, I THINK WHEN WE ASKED PEOPLE
TO CONSIDER IT OR WE ENCOURAGED
THAT, THEY MAY OR MAY NOT DO IT.
I FEEL THAT THE LANGUAGE HAS TO
BE A LOT STRONGER SO THAT COULD
BECOME SOMETHING THAT WE THINK
ABOUT AND SOLVE IT BECAUSE I
THINK THEY CAN.
I LIKE THE IDEA MAKING SURE WE
HAVE PARTICIPANTS ON THE TEAM
THAT ARE FROM DIVERSE BACKGROUND
TO BRING THEIR PERSPECTIVES WHO
-- WHO HOW WE DO IT AND WHY
WE DO WHAT WE DO.
I'M TOTALLY BEHIND THE SAME
QUESTIONING AROUND HOW WE MAKE
SURE WE DON'T ASK THEM TO
CONSIDER, BECAUSE CONSIDER MEANS
YOU COULD, YOU COULD NOT.
SO GOING FROM CONSIDER AND
UNDEVELOPING TO IMPLEMENTED THE
BEST PRACTICES IN THAT STUDY.
SO OUTSIDE OF THAT I LOVE THE
IDEA HAVING PLATFORMS THAT WOULD
BE AVAILABLE TO OTHERS OUTSIDE
OF THE PEOPLE THAT HAPPEN TO BE
IN THIS GROUP RIGHT NOW.
>> THANK YOU.
I HEAR THE MESSAGE AND WE'LL
MAKE THE LANGUAGE STRONGER AND
PROVIDING NO WIGGLE ROOM FOR
INVESTIGATORS THAT ARE APPLYING.
I WOULD MENTION THAT OUR
INVESTIGATORS ARE LEADERS IN
THIS PARTICULAR ASPECT OF THE
THERAPY DELIVERY.
THEY WANT -- THEY ARE BEYOND
JUST TALKING ABOUT IT.
THEY ARE THINKING ABOUT
STRATEGIES TO PROVIDE THIS
TECHNOLOGY TO BROADER
POPULATIONS, WHAT NEEDS TO BE
DONE, WHAT NEEDS TO BE PUT IN
PLACE TO MAKE SURE THAT ALL
COMMUNITIES ARE SERVED BY THIS
TECHNOLOGY.
>> THAT'S A VERY CRITICAL
ASPECT.
SORRY, JEAN.
>> I WAS JUST SAYING THANK YOU.
>> THANK YOU VERY MUCH.
>> GREAT.
ALL RIGHT.
WELL, NOW LET'S OPEN UP FOR
BROADER QUESTION AND DISCUSSION,
IF OTHERS ON COUNCIL HAVE ANY
ADDITIONAL COMMENTS, I SEE,
KAREN, YOU'RE ECHOING SOME OF
THE COMMENTS THAT HAVE ALREADY
BEEN MADE ABOUT DIVERSITY OF
RECRUITMENT STRATEGIES.
JENNIFER, I SEE YOUR HAND UP.
>> YES, I JUST WANTED TO, YOU
KNOW, SAY I THOUGHT THE REVIEWS
WERE GREAT OF THIS CONCEPT.
AND WONDER IF PART OF WHAT DR.
KING MENTIONED WAS ABOUT THE
TEAM COMING IN FOR THESE
RENEWALS OR FOR THIS ADDITIONAL
FUNDING, THAT THEY INCLUDE
EXPERTS IN EITHER DISPARITIES IN
THE DISEASE UNDER STUDY OR
CERTAINLY EXPERTS IN THE SCIENCE
OF INCLUSION.
I WONDER IF THE LANGUAGE OF THE
NOFO COULD BE STRENGTHENED BY
STATING EXPLICITLY THAT RESPONSE
OF APPLICATIONS WOULD INCLUDE
EXPERTS IN SCIENCE OF INCLUSION.
YOU KNOW, I THINK THAT, AGAIN,
IT'S REASSURING AND HEARTENING
THAT THESE INVESTIGATORS HAVE
BEEN CONSIDERING THESE
DISPARITIES IN DELIVERY OF
TREATMENTS, BUT THEY ARE NOT
LIKELY TO BE EXPERTS IN THE
SCIENCE OF INCLUSION.
AND JUST TO SAY THAT MANY OF
THESE DISORDERS, YOU KNOW, THE
PLACES WHERE PEOPLE ARE TREATED
WITH THEM DIFFERS WIDELY,
DEPENDING ON SOME OF THESE
BACKGROUND CHARACTERISTICS, YOU
KNOW, SOURCES OF DISPARITIES,
GROUP DIFFERENCES, SUBGROUP
DIFFERENCES, FINALLY IF THERE
ARE -- IF THE APPLICATIONS ARE
GOING TO INCLUDE ANALYSIS OF
WHETHER THE TREATMENTS HAVE
SIMILAR EFFECTS ACROSS GROUPS
THEY NEED TO BE WELL POWERED IN
ORDER TO DO THAT.
AND SO A VERY THOUGHTFUL SET OF
ANALYSES NOT JUST CONVENIENCE
SAMPLING IS NEEDED IN ORDER TO
MAKE THOSE ANALYSES SUCCESSFUL.
>> THANK YOU FOR THE COMMENTS.
AND I, AGAIN, HEAR THAT
SUGGESTION AND I WILL BE SURE
THAT THAT IS INCLUDED IN THE
FUNDING ANNOUNCEMENT,
APPROPRIATE EXPERTISE FOR
RECRUITING DIVERSE POPULATIONS
IS INCLUDED IN THE TEAM, WHERE
THEY SUBMIT APPLICATIONS, OR AS
A RESPONSIVENESS CRITERIA FOR
SUCCESSFUL APPLICATION.
>> I'M SEEING A FEW ECHOES OF
SUPPORT FOR THOSE COMMENTS AND
STATEMENTS.
SO IMPORTANT TO CONSIDER.
ALL RIGHT.
I'M LOOKING TO SEE --
>> CAN I ASK A FOLLOW-UP
QUESTION?
>> SURE, GO AHEAD.
>> I MIGHT BE MISSING SOMETHING.
IS THERE SOMETHING SPECIFIC TO
THIS CONCEPT, CLINICAL TRIALS,
COMPARED TO OTHERS THAT THIS IS
MORE OF A CONCERN?
ISN'T THIS -- DOESN'T NIH ALWAYS
DO THIS FOR CLINICAL TRIALS,
REQUIRE THAT POPULATIONS BE
REPRESENTED?
>> WE HAVE AN INCLUSION POLICY.
I THINK YOU'RE REFERRING TO OUR
INCLUSION POLICY THAT WE HAVE
FOR PARTICULAR GROUPS, INCLUDING
WOMEN AND RACIAL AND ETHNIC
MINORITIES.
BUT, TIM, I DON'T KNOW IF YOU
WANT TO SPEAK FURTHER ON THIS
SPECIFICALLY.
>> YOU'RE CORRECT, IT IS A
REQUIREMENT FOR ALL FUNDING
ANNOUNCEMENTS, BUT IF THE
LANGUAGE IS ABSENT,
INVESTIGATORS MAY NOT BE
REMINDED.
AND SO I THINK IT'S IMPERATIVE
ON THE SCGE TO BE SURE THAT
LANGUAGE SIN INCLUDED IN ANY
FUNDING ANNOUNCEMENT WE PUT OUT
SO WE'LL MAKE SURE THAT IS
INCLUDED.
I THINK THERE IS SOME -- THERE
ARE SOME SPECIAL CONSIDERATIONS
HERE FOR GENE THERAPIES AND
GENOME EDITING THERAPY, IT'S
RELATIVELY NEW.
PEOPLE ARE NOT FAMILIAR WITH THE
TECHNOLOGY, HAVING PEOPLE
COMFORTABLE WITH THE TECHNOLOGY
IS GOING TO REQUIRE WORK, AND SO
I THINK INCLUDING APPROPRIATE
EXPERTISE TO MAKE SURE ALL
COMMUNITIES THAT ARE CONSIDERING
PARTICIPATING IN THE TRIAL ARE
COMFORTABLE WITH THE TECHNOLOGY
AND THE RISK AND BENEFITS OF
THOSE THINGS.
AND SO WE'LL MAKE EXTRA EFFORT
TO BE SURE THAT THOSE THINGS ARE
INCLUDED IN THIS PARTICULAR
FUNDING ANNOUNCEMENT.
>> THANK YOU.
>> OKAY.
I'M NOT SEEING ANY ADDITIONAL
HANDS OR COMMENTS.
MONICA PUT IN ONE ECHOING
SUPPORT FOR DIVERSITY OF TEAM
MEMBERS.
BUT NOT SEEING ANYTHING ELSE,
MAYBE WE'LL OPEN IT UP NOW FOR
THE VOTE.
>> ALL RIGHT.
GREAT.
THANK YOU, TARA AND COUNCIL AND
PRESENTER.
I'LL BE CALLING FOR A VOTE.
ALTHOUGH THE WORDS WRITTEN IN
THE VOTE REFLECT -- WILL BE
REFLECTING THE STATEMENT,
MODIFIED A LITTLE BIT WITH THE
PREAMBLE OF WHAT I HEARD.
SO I WILL BE CALLING FOR A VOTE
FOR THE PRESENTED CONCEPT, FROM
OSC, INCLUDING COMPONENT TO
ENHANCE DIVERSITY WITH STRONG
LANGUAGE TO ENHANCE DIVERSE
BACKGROUNDS AND EXPERT IN
SCIENCE OF INCLUSION AND
ASSOCIATED ANALYSIS, FOR THE
CONCEPT CLEARANCE ENTITLED
SOMATIC CELL GENOME EDITING
CLINICAL TRIALS.
TO SUPPORT PLEASE TYPE.
SO MOVE INTO THE CHAT.
I HOPE IT WAS CLEAR WHAT I WAS
TRYING TO DO, I ADDED THE
DISCUSSION I HEARD WITH THE
STRONG SUPPORT.
I SEE SO MOVED.
BEFORE I COULD SAY THANK YOU
VERY MUCH, I SEE A SECOND.
I WILL NOW ASK IF THERE'S ANY
ADDITIONAL DISCUSSION ON THIS
VOTE.
I DO NOT SEE ANYTHING IN THE
CHAT.
I DO NOT SEE ANY HANDS RAISED.
SO I'M GOING TO TURN IT OVER TO
THE HOST FOR THE VOTE.
>> THANK YOU, DR. GRIEDER.
OF POLL SHOULD AUTOMATICALLY
APPEAR ON YOUR SCREEN, WHEN
LAUNCHED.
PLEASE REMEMBER TO HIT SUBMIT
AFTER YOU HAVE SELECTED YOUR
VOTE AND AS A REMINDER ONLY
COUNCIL MEMBERS SHOULD
PARTICIPATE IN THE POLL.
THE POLL IS STARTING NOW.
YOU HAVE ABOUT 15 SECONDS
REMAINING IN ORDER TO CAST YOUR
VOTE.
PLEASE REMEMBER TO HIT SUBMIT.
ALL RIGHT.
THE POLL IS NOW CLOSING.
I WILL SHARE THE RESULTS WITH
THE MEETING.
THE MOTION AS STATED HAS PASSED.
>> GREAT.
THANK YOU, CHRISTINA AND COUNCIL
MEMBERS AND PRESENTERS FOR THIS
CONCEPT.
WE WILL MOVE FORWARD AND I'LL
HAND IT BACK OVER TO TARA.
WE'RE RIGHT ON TIME.
>> I SEE THAT.
THE SWISS TIME KEEPING WE HAVE
HERE.
ALL RIGHT.
SO, WE'RE ACTUALLY NOW GOING TO
TRANSITION TO TAKE A LUNCH
BREAK.
SO, BEFORE WE DO, I THANK YOU
ALL FOR THOUGHTFUL COMMENTS AND
SUGGESTIONS RELATED TO THAT
CONCEPT.
OF COURSE THEY WILL TAKE THEM
INTO CONSIDERATION AND GO BACK
AND CONSIDER HOW TO WORK TO
ENHANCE SOME OF IN A LANG --
SOME OF THAT LANGUAGE.
AS WE TRANSITION TO LUNCH, WE
ASK YOU AGAIN TO PLEASE REMAIN
LOGGED IN, AND MUTED, COUNCIL
MEMBERS.
COME BACK A COUPLE MINUTES
BEFORE 1:00, AND AT THAT POINT
WE'LL GET GOING ON THE AFTERNOON
PRESENTATIONS, INCLUDING OUR
FIRST PRESENTATION BACK FROM
LUNCH FROM DR. DIANA BIANCHI,
WHO IS DIRECTOR OF NICHD.
SO WITH THAT, PLEASE ENJOY YOUR
LUNCH, OR MAYBE IT'S JUST A
SNACK BREAK FOR THOSE ON THE
WEST COAST.
AND WE'LL SEE YOU BACK IN ABOUT
25 MINUTES OR SO.
THANKS.
>> ALL RIGHT, EVERYONE.
WELCOME BACK.
WE'RE GOING TO KICK THINGS OFF
POST-LUNCH, OR AS RICHARD
INDICATED, A LATE BREAKFAST FOR
THOSE WHO ARE ON THE WEST COAST.
OUR NEXT PRESENTATION IS FROM
THE DIRECTOR OF THE EUNICE
KENNEDY SHRIVER NATIONAL
INSTITUTE OF CHILD HEALTH AND
HUMAN DEVELOPMENT, DR. DIANA
BIANCHI, IN THIS ROLE SINCE
2016, EIGHT YEARS, OVERSEES
INSTITUTE'S RESEARCH ON
PEDIATRIC HEALTH AND
DEVELOPMENT, MATERNAL AND
REPRODUCTIVE HEALTH,
INTELLECTUAL AND DEVELOPMENTAL
DISABILITIES ANDREHABILITATION
MEDICINE, AMONG OTHER AREAS,
SPEARHEADING EFFORTS ON THE
NICHD STRATEGIC PLAN AND OVERSAW
CRAFTING AND VETTING OF
INSTITUTE'S NEW VISION AND
MISSION STATEMENTS.
SHE ALSO LEADS AND INTRAMURAL
RESEARCH LAB IN HER SPARE TIME,
IN THIS PRECISION HEALTH
RESEARCH AT NATIONAL HUMAN
GENOME RESEARCH INSTITUTE,
FOCUSING ON PRENATAL GENOMICS
WITH THE GOAL OF ADVANCING
NON-INVASIVE PRENATAL DNA
SCREENING AND ALSO THE DIAGNOSIS
AND INVESTIGATION OF THE FETAL
TRANSCRIPTOME TO HELP DEVELOP
NEW THERAPIES FOR GENETIC
DISORDERS THAT CAN BE GIVEN
PRENATALLY.
WITH THAT I WILL TURN IT OVER TO
DIANA TO TALK MORE ABOUT SOME OF
THE COOL THINGS SHE HAS GOING ON
AT NICHD.
DIANA?
>> NOT QUITE EIGHT YEARS,
NOVEMBER 2016, SO ELECTION DAY
IN 2024 WILL BE MY EIGHTH YEAR
ANNIVERSARY, AND IT'S BEEN A
WILD TIME.
THIS IS THE FIRST TIME I'VE
SPOKEN TO THE COUNCIL OF
COUNCILS, SO IT'S A GREAT
PLEASURE TO BE WITH ALL OF YOU
IF ONLY VIRTUALLY.
MAY I HAVE THE NEXT SLIDE
PLEASE.
SO, I HAVE A LOT TO COVER.
I'M PLANNING TO TALK FOR 35
MINUTES AND LEAVE 10 MINUTES FOR
QUESTIONS.
OVERVIEW OF NICHD, AND THEN TALK
ABOUT OUR THREE MAIN FOCUS
AREAS, WHICH IS WOMEN'S HEALTH
WHICH WE'RE CALLING BELOW THE
BELT, I'LL EXPLAIN WHAT THAT
MEANS.
PEDIATRIC RESEARCH,
REHABILITATION RESEARCH, AND
BECAUSE THE COUNCIL OF COUNCILS
IS REALLY LOOKING AT THESE
CROSS-I.C. LARGE PROGRAMS, I'M
GOING TO HIGHLIGHT THREE THAT
WE'RE INVOLVED IN, THE "IMPROVE"
INITIATIVE TO ADDRESS MATERNAL
MORTALITY, THE "INCLUDE"
PROGRAM, LOOKING AT IMPROVING
THE LIVES OF PEOPLE WITH DOWN
SYNDROME, AND THEN HELPING TO
END ADDICTION LONG TERM AND HOW
THAT AFFECTS PAIN IN OUR
POPULATIONS AS WELL AS
PARTICULARLY NEONATES, WHO ARE
BORN TO MOTHERS WHO MISUSED
SUBSTANCES DURING THEIR
PREGNANCIES.
NEXT SLIDE PLEASE.
SO, ONE OF THE THINGS THAT WE
DID ACCOMPLISH IN THE LAST EIGHT
YEARS OR SO HAS BEEN TO RECRAFT
OUR MISSION AND VISION
STATEMENTS.
WHEN I CAME ON BOARD WE HAD A
VERY LONG MISSION STATEMENT THAT
NOBODY COULD REMEMBER, AND IT
WAS QUITE FRANKLY A LITTLE BIT
ON THE DEPRESSING SIDE.
SO, AFTER A LOT OF WORK WE CAME
UP WITH A NEW MISSION STATEMENT,
THAT NICHD LEADS RESEARCH AND
TRAINING TO UNDERSTAND HUMAN
DEVELOPMENT, IMPROVE
REPRODUCTIVE HEALTH, ENHANCE
LIVES OF CHILDREN AND
ADOLESCENTS, OPTIMIZE ABILITIES
FOR ALL.
AND IF WE'RE ABLE TO ACCOMPLISH
OUR MISSION, OUR VISION TO HAVE
HEALTHY PREGNANCIES, HEALTHY
CHILDREN, HEALTHY AND OPTIMAL
LIVES.
NEXT SLIDE PLEASE.
SO IN 2020, WE UNDERWENT OUR
FIRST STRATEGIC PLAN IN OVER 20
YEARS.
WE'RE $1.75 BILLION INSTITUTE,
AND IT'S AMAZING THERE WAS NO
STRATEGIC PLAN.
SO WHAT THERE WAS, THERE WERE A
LOT OF GRANTS, BUT THEY WERE
VERY DIFFUSION. -- DIFFUSE, WE O
DEEP.
WITH THE STRATEGIC PLAN WE
STARTED WITH 270 POSSIBLE THEMES
AND DISTILLED TO FIVE.
UNDERSTANDING MOLECULAR,
CELLULAR, STRUCTURAL BASIS OF
DEVELOPMENT; PROMOTING GIN
CONGESTIONIC AND REPRODUCTIVE
HEALTH, SETTING FOUNDATION FOR
HEALTHY PREGNANCY AND WELLNESS,
IMPROVING CHILD AND ADOLESCENT
HEALTH IN TRANSITION TO
ADULTHOOD AND ADVANCING SAFE AND
EFFECTIVE THERAPEUTICS.
WE THINK THE THEMES HAVE HELD UP
WELL.
WHEN WE WROTE THEM THIS WAS
PRIOR TO THE PANDEMIC AND PRIOR
TO THE GEORGE FLOYD EPISODE, ET
CETERA.
WE'RE PLANNING TO KEEP THESE
THEMES BUT TWEAK THEM IN THE
REFRESH OF OUR STRATEGIC PLAN,
WHICH IS GOING TO COME FIVE
YEARS LATER, IN THE SPRING OF
2025.
NEXT SLIDE PLEASE.
SO, OUR NAME DOESN'T CONVEY WHAT
WE DO.
YOU GOT A SENSE FROM WHAT I'VE
SAID.
WE WERE NAMED FOR EUNICE KENNEDY
SHRIVER, PRESIDENT KENNEDY'S
SISTER.
THIS IS A TERRIFIC BIOGRAPHY, IF
YOU'RE INTERESTED IN SORT OF THE
HISTORY OF THE INSTITUTE AS WELL
AS SPECIAL OLYMPICS AND THE
KENNEDY FAMILY.
OUR RELATIONSHIP WITH THE
KENNEDY FAMILY CONTINUES TODAY.
THE PICTURE ON THE RIGHT IS A
PICTURE THAT WAS JUST TAKEN A
FEW WEEKS AGO.
AND IT REALLY RELATES TO WHAT'S
GOING ON NOW, MARIA SHRIVER IS
ONE OF THE LEADING FIGURES IN
THE -- [ AUDIO DISTORTION ]
>> DR. BIANCHI?
>> YES?
>> WE LOST YOU THERE FOR A
MOMENT.
>> CAN YOU HEAR ME NOW?
>> YES.
>> LET ME GO OFF VPN TOO, I
REALIZED I'M ON VPN.
OKAY.
AT WHAT POINT DID YOU LOSE ME?
>> YOU WERE TALKING ABOUT
KENNEDY SHRIVER.
>> THE SISTER OF PRESIDENT
KENNEDY, WHOSE IDEA IT WAS TO
HAVE AN INSTITUTE DEVOTED TO OUR
POPULATIONS, BY THE WAY MATERNAL
HEALTH WAS THERE FROM THE VERY
BEGINNING.
ON THE RIGHT IS A PICTURE THAT
WAS JUST TAKEN A FEW WEEKS AGO,
WITH MARIA SHRIVER, WHO IS A
LEADING FIGURE IN THE WOMEN'S
HEALTH RESEARCH INITIATIVE,
WHICH I'LL BE TALKING ABOUT IN A
MOMENT, AND TIM SHRIVER, HER
BROTHER, WHO SERVED ON OUR
ADVISORY COUNCIL, AND IS THE
EXECUTIVE DIRECTOR OF THE
SPECIAL OLYMPICS AND IS A
TREMENDOUS ADVOCATE FOR PEOPLE
WITH INTELLECTUAL DISABILITIES.
SO, ABOUT 55% OF OUR PORTFOLIO
IS IN PEDIATRIC HEALTH, AROUND
30% IN REPRODUCTIVE HEALTH, FROM
DEVELOPMENT OF REPRODUCTIVE
ORGANS TO CONTRACEPTION TO
PREGNANCY TO POSTPARTUM, AND UP
UNTIL EARLY MENOPAUSE INCLUDING
EARLY MENOPAUSE.
AND ABOUT 15% INCLUDES
INTELLECTUAL AND DEVELOPMENTAL
DISABILITIES AND REHABILITATION,
INCLUDING ADULT REHABILITATION.
AND THAT'S THE NATIONAL CENTER
FOR MEDICAL REHABILITATION
RESEARCH, WHICH SITS IN OUR
INSTITUTES.
NEXT SLIDE PLEASE.
SO, I'M GOING TO BRIEFLY TALK
ABOUT EACH OF THESE TOPICS.
TO DISTINGUISH WHAT WE DO FROM
OTHER ASPECTS OF WOMEN'S HEALTH
ACROSS NIH WE'RE CALLING IT
BELOW THE BELT, MEANING THE
REPRODUCTIVE ORGANS.
BELOW THAT WE HAVE SOME OF OUR
12 EXTRAMURAL BRANCHES THAT ARE
ALL FUNDING RESEARCH IN WOMEN'S
HEALTH, INCLUDING GYNECOLOGIC
HEALTH AND DISEASE,
CONTRACEPTION, FERTILITY AND
INFERTILITY, PREGNANCY AND PERI
NATALLOLOGY.
WE'VE INVESTED GOES TO $90
MILLION ON THE HUMAN PLACENTA
PROJECT BECAUSE WE BELIEVE THE
PLACENTA IS A KEY ORGAN THAT
AFFECTS BRAIN DEVELOPMENT AND
LIFETIME HEALTH.
HEALTH OF THE PLACENTA IS
EXTREMELY IMPORTANT, CONNECTED
TO RISK OF DISEASE LATER IN
LIFE.
HUMAN PLACENTA PROJECT STARTED
IN 2014, WITH THE GOAL OF
LOOKING AT THE PLACENTA NOT
INVASE IVELY AND IN REAL TIME.
WE CAN LOOK AFTER DELIVERY BUT
IT'S TOO LATE.
WHAT'S BEEN ACCOMPLISHED
INCLUDES ENHANCED IMAGING BOTH
WITH MRI AND ULTRASOUND TO GET A
MORE DETAILED VIEW OF THE
PLACENTA AND TO LOOK TO SEE HOW
BLOOD OXYGEN AND NUTRIENTS FLOW
ACROSS THE VESSELS.
THERE'S BEEN WORK IN
NON-INVASIVE BIOMARKERS FROM
MATERNAL BLOOD THAT REFLECT
HEALTH AND FUNCTION OF THE
PLACENTA TO INTERVENE EARLIER IF
NEEDED.
AS PART OF THE WOMEN'S HEALTH
RESEARCH INITIATIVE WE'RE
COMMITTING $3 MILLION TO A
CHALLENGE IN ENDOMETRIOSIS.
WE CALLED IT OUT IN OUR
STRATEGIC PLAN AS ONE OF OUR
ASPIRATIONAL GOALS.
WE'RE BASED ON THE LIFESPAN, NOT
NECESSARILY ASSOCIATED WITH
SPECIFIC DISEASES OR CONDITIONS.
BUT WE FELT THAT ENDOMETRIOSIS
WAS A CONDITION THAT IS
EXTREMELY COMMON, AFFECTS 1 IN
10 WOMEN INDEPENDENT OF RACIAL
OR ETHNIC ORIGIN.
AND THE BIG PROBLEM IS ON
AVERAGE IT TAKES 7 TO 10 YEARS
TO MAKE THE DIAGNOSE, AND MOST
OF THE TIME THE DIAGNOSIS IS
MADE BY AN INVASIVE PROCEDURE,
LAPAROSCOPY.
SO CURRENTLY THERE'S NO RELIABLE
BLOOD TEST OR A NON-INVASIVE
DIAGNOSTIC TEST.
SO, IT'S A LONG JOURNEY FOR
PEOPLE WHO HAVE IT, AND IT
RELIES ON MEDICAL HISTORY,
RELIES ON A CARE PROVIDER WHO
KNOWS WHAT IT IS.
AND EVENTUALLY IT DOES COME TO
LAPAROSCOPY.
SO, WE ARE GOING TO DEVOTE
RESOURCES TO A CHALLENGE TO
DEVELOP RELIABLE NON-INVASIVE
TESTS THAT ENABLE EARLY AND
ACCURATE DIAGNOSIS AND
TREATMENT.
NEXT SLIDE PLEASE.
SO, THE RADX-TECH MECHANISM THAT
WAS USED SO SUCCESSFULLY DURING
THE COVID PANDEMIC IS GOING TO
BE APPLIED TO A CHALLENGE IN
WHICH INVESTIGATORS, COMPANIES,
ARE GOING TO BE ASKED TO HELP US
TO BE ABLE TO DIAGNOSE
ENDOMETRIOSIS IN A MUCH SHORTER
PERIOD OF TIME.
AND THE ACT ENDOSTANDS FOR
ADVANCING CURES AND THERAPIES
AND ENDING ENDOMETRIOSIS
DIAGNOSTIC DELAY.
WE WILL BE PARTNERING WITH NIBIB
AND AGAIN WE'RE GOING TO
LEVERAGE THE VERY SUCCESSFUL
RAPID ACCELERATION OF
DIAGNOSTICS TECHNOLOGY
INNOVATION FUNNEL THAT RESULTED
FOR EXAMPLE IN SOME HOME-BASED
TESTS WE'VE BECOME QUITE
FAMILIAR WITH USING TO
SELF-DIAGNOSE COVID-19.
WE HOPE THAT THIS WILL
ACCELERATE THE TIME TO
DIAGNOSIS, ELIMINATE NEED FOR
LAPAROSCOPY, AND REDUCE COSTS
AND IMPROVE COMFORT FOR THE
PATIENT.
WE'RE LOOKING NOT JUST FROM
BLOOD BUT PERHAPS SALIVA, OR
EVEN MENSTRUAL EFFLUENT TO LOOK
FOR SPECIFIC BIOMARKERS.
AND, YOU KNOW, ALL ENDOMETRIOSIS
IS MALIGNANT IN THE SENSE THAT
IT'S PAINFUL, BUT SOME OF THE
LESIONS DO HAVE THE POTENTIAL TO
BECOME MALIGNANT IN THE
CANCEROUS TERM, AND WOMEN WHO
HAVE ENDOMETRIOSIS ARE AT RISK
FOR A VARIETY OF ASSOCIATED
CONDITIONS, PARTICULARLY
AUTOIMMUNE CONDITIONS.
WE ALSO ARE LOOKING FOR PEOPLE
WHO CAN UTILIZE EPIGENETIC OR
GENOMIC DATA WITH MACHINE
LEARNING TO, AGAIN, IDENTIFY
PEOPLE AT RISK AND DIAGNOSE
DISEASE AT AN EARLIER STAGE.
NEXT SLIDE PLEASE.
HERE IS THE SHARK TANK.
THAT'S WHY THERE'S A LITTLE
PICTURE OF A SHARK THERE.
AND WE ARE USING THIS TYPE OF
CHALLENGE IN ANOTHER AREA IN
MATERNAL HEALTH THAT I CAN TALK
ABOUT IN A MOMENT, BUT IT IS
PHASED, SO DIFFERENT INNOVATORS,
DIFFERENT COMPANIES, DIFFERENT
INVESTIGATORS WILL ENTER AND
THEN THE GROUP IS EVENTUALLY
WINNOWED DOWN BUT AT EACH STAGE,
AS INNOVATORS PROCEED TO THE
NEXT LEVEL, THEY DO GET A
FINANCIAL PRIZE.
NEXT SLIDE PLEASE.
SO ANOTHER AREA THAT WE'RE
INVOLVED, QUOTE/UNQUOTE, BELOW
THE BELT IS VIA THE 21ST CENTURY
CURES ACT.
WE HAD BEEN ASKED TO LEAD A TASK
FORCE ON RESEARCH SPECIFIC TO
PREGNANT AND LACTATING PEOPLE,
KNOWN AS PRGLAC.
AND THE CONCERN IS THAT MANY
MEDICATIONS, IN FACT MOST, HAVE
NOT BEEN TESTED FOR SAFETY AND
EFFICACY PERSPECTIVE ON PREGNANT
OR LACTATING PEOPLE.
SO THEREFORE PREGNANT PEOPLE FOR
EXAMPLE ARE FORCED TO DECIDE
BETWEEN MEDICATIONS THEY TAKE
FOR THEIR OWN HEALTH VERSUS NOT
TAKING ANYTHING, WITH THE
PERCEPTION, CULTURALLY
PERCEPTION, NOT TAKING ANYTHING
IS BETTER FOR THE BABY, THAT
PROBABLY MOST CASES IS NOT TRUE.
SO THIS HAS BEEN A VERY
IMPORTANT TASK FORCE THAT HAS
BEEN ONGOING FOR THE LAST SIX
YEARS.
WE CAME UP WITH 15
RECOMMENDATIONS.
THIS WAS JUST NOT JUST NICHD,
ALTHOUGH NICHD LED THE TASK
FORCE.
WE HAD OTHER INSTITUTES AND
CENTERS INVOLVED, OTHER FEDERAL
PARTNERS, ACADEMIC PARTNERS,
ADVOCACY ORGANIZATIONS, AND
PHARMA.
AND SO THE RECOMMENDATIONS WERE
TO INCLUDE PREGNANT AND
LACTATING PEOPLE IN CLINICAL
RESEARCH, TO INCREASE RESEARCH
ON THE SAFETY AND EFFICACY OF
THERAPEUTICS USED BY PREGNANT
AND LACTATING PEOPLE.
AND DEVELOP PROGRAMS TO DRIVE
DISCOVERY AND DEVELOPMENT OF
THERAPEUTICS, AND INCLUDE NEW
THERAPEUTICS FOR CONDITIONS
SPECIFIC TO PREGNANT AND
LACTATING PEOPLE.
AS WELL AS EXPANDING THE
WORKFORCE OF CLINICIANS AND
RESEARCHERS WHO HAVE EXPERTISE
IN THESE AREAS.
SO, THE 15 RECOMMENDATIONS HAVE
LONG BEEN MADE PUBLICLY
AVAILABLE.
THEN THERE WAS ANOTHER TASK
FORCE TO LOOK AT IMPLEMENTATION
OF THE RECOMMENDATIONS, AND NOW
AT OUR UPCOMING COUNCIL MEETING
WE'LL PROVIDE AN UPDATE ON WHERE
WE ARE, AND I THINK WHAT'S VERY
GRATIFYING, I READ THE REPORT,
ALMOST ALL OF THE
RECOMMENDATIONS HAVE HAD
SIGNIFICANT ADVANCES IN TERMS OF
EITHER BEING IMPLEMENTED OR
BEING ABOUT TO BE IMPLEMENTED,
AND MOST RECENTLY, FOR EXAMPLE,
THE NATIONAL ACADEMIES HAD A
MEETING LOOKING AT LEGAL
LIABILITIES FOR PHARMACEUTICAL
MANUFACTURERS, AND THEY COULD
NOT COME UP WITH AN EXAMPLE OF A
COMPANY THAT HAD BEEN SUED FOR
GIVING MEDICINE TO A PREGNANT
PERSON IN THE LAST SEVERAL
DECADES.
SO, AGAIN, WE'RE TRYING TO
CHANGE THE CULTURE, WE DO SENSE
MOVEMENT HERE.
NEXT SLIDE PLEASE.
WHAT HAS NICHD DONE?
WE'VE COMMITTED RESOURCES TO A
NUMBER OF DIFFERENT AREAS.
WE'VE CREATED A HUB THAT HAS AN
EDUCATIONAL GOAL.
IT ALSO IS AN OPPORTUNITY FOR
DIFFERENT INVESTIGATORS TO
EXPAND THEIR OWN RESEARCH ON
SAFE AND EFFECTIVE THERAPIES.
WE'RE ALSO FUNDING A GROUP IN
UTAH, CALLED THE CUDDLE STUDY,
WHERE THEY ARE LOOKING AT
COMMONLY USED DRUGS DURING
LACTATING -- DURING LACTATION,
AND IT'S AN OPPORTUNISTIC STUDY
WHERE THEY ARE TAKING A SAMPLE
OF BREAST MILK, TAKING MATERNAL
BLOOD SAMPLE, TAKING A HEEL
STICK BABY BLOOD SAMPLE, AND
THEY ARE ESSENTIALLY PROVING
THAT ALMOST NO MEDICATION IS
GETTING INTO THE BABY'S BLOOD.
SO, PROVIDING REASSURANCE TO
PARENTS THAT IT IS SAFE FOR THE
MOTHERS, FOR MEDICAL REASONS, TO
CONTINUE ON A GROUP OF
MEDICATIONS.
SO, THE ONES THEY HAVE JUST
MOVED MOST RECENTLY STUDY
INCLUDE AMOXICILLIN,
BUPRENORPHINE, HYDROCODONE.
BUT THIS IS THE EVIDENCE THAT'S
BEEN LACKING THAT IS IMPORTANT
FOR BOTH PEDIATRICIANS AND
OBSTETRICIANS TO BE REASSURED
THAT IT IS SAFE FOR THE MOTHER
TO CONTINUE TAKING THESE
MEDICINES.
NEXT SLIDE PLEASE.
WE SUPPORT RESEARCH NETWORKS FOR
MATERNAL AND INFANT HEALTH,
INCLUDING NEONATAL RESEARCH
NETWORK, GLOBAL NETWORK FOR
WOMEN'S AND CHILDREN HEALTH
RESEARCH.
AND WE MAKE SOME IMPORTANT
CHANGES, NETWORKS HAVE HAVE BEEN
AROUND 30-ISH YEARS, THEY HAD A
GROUP OF INVESTIGATORS WHO
WORKED TOGETHER, DETERMINED WHAT
WOULD BE STUDIED.
WE'VE BROKEN THAT OPEN, AND
INCREASED EXTERNAL PEER REVIEW
THESE NETWORKS AS WELL AS
PROVIDING AN INFRASTRUCTURE THAT
ALLOWS INVESTIGATORS FROM ALL
OVER THE COUNTRY NOT FOR THE
GLOBAL NETWORK BUT THE DOMESTIC
NETWORKS RESEARCHERS FROM ALL
OVER THE COUNTRY CAN PROPOSE
STUDIES THAT ARE THEN EXTERNALLY
VALIDATED, CAN USE THE
INFRASTRUCTURE OF THE NETWORKS.
THE GLOBAL NETWORK CONSISTS OF
EIGHT SITES IN SEVEN COUNTRIES,
THIS IS A LONG-TERM NETWORK THAT
VERY RECENTLY, I THINK NEXT
SLIDE PLEASE, YES, THE GLOBAL
NETWORK WAS VERY RECENTLY USED
TO STUDY A SINGLE DOSE
AZITHROMYCIN GIVEN TO WOMEN IN
LABOR AROUND THE WORLD, THIS WAS
A STUDY CO-SPONSORED BY THE
FORMER BILL AND MELINDA GATES
FOUNDATION, NOW THE GATES
FOUNDATION, THAT WAS TESTING
WHETHER SINGLE DOSE OF
AZITHROMYCIN COULD REDUCE
POSTPARTUM SEPSIS AND DEATH,
STOPPED EARLY BECAUSE A THIRD
FEWER WOMEN DEVELOPED SEPSIS IN
DEATH WITH A SINGLE DOSE OF
AZITHROMYCIN, DID NOT HAVE
AFFECT ON THE BABIES PROBABLY
BECAUSE OF AMOUNT OF EXPOSURE
FOR THE BABIES WAS SO LOW.
NEXT SLIDE PLEASE.
IT LED TO PEDIATRIC RESEARCH.
WE'VE GOT A NUMBER OF DIFFERENT
BRANCHES THAT ARE FOCUSING ON
TOPICS RELATED TO CHILDREN
INCLUDING DEVELOPMENTAL BIOLOGY,
CONGENITAL ANOMALIES, CHILD
DEVELOPMENT AND BEHAVIOR,
INTELLECTUAL AND DEVELOPMENTAL
DISABILITIES, GROWTH AND
NUTRITION, TRAUMA, CRITICAL
ILLNESS, INFECTIOUS DISEASE,
PHARMACOLOGY, AND POPULATION
DYNAMICS.
NEXT SLIDE PLEASE.
SO WE HAVE INTELLECTUAL AND
DEVELOPMENTAL DISABILITY
RESEARCH CENTERS.
THESE INCLUDE 15 RESEARCH
CENTERS ACROSS THE UNITED
STATES.
THESE ALSO INCLUDE
INFRASTRUCTURE AND RESEARCH
PROJECTS.
WE ALSO PARTNER LARGELY WITH
NIMH ON AUTISM RESEARCH.
WE HAVE AUTISM CENTERS OF
EXCELLENCE THAT ARE ACTUALLY
CO-SPONSORED BY A NUMBER OF
DIFFERENT INSTITUTES, AND THESE
CENTERS ARE PART OF THE CENTERS,
YOU KNOW, MAINLY FOCUSED ON
EARLY DIAGNOSIS.
BUT WE ALSO ARE STUDYING THE
BEST INTERVENTIONS FOR AUTISM
SPECTRUM DISORDER, AS WELL AS
SERVICES FOR PEOPLE THROUGHOUT
THE LIFESPAN.
WE'RE SPENDING $100 MILLION ON
OUR NINE AWARDS FOR THESE
CENTERS OF EXCELLENCE.
NEXT SLIDE.
A BIG AREA THAT, YOU KNOW, HAS
ALWAYS BEEN OF INTEREST SINCE
I'VE BEEN AT NIH, MORE SO DURING
THE PANDEMIC, RELIANCE ON
TECHNOLOGY AND DIGITAL MEDIA,
AND HOW IT AFFECTS TYPICAL CHILD
DEVELOPMENT.
SO, WE WERE GIVEN $15 MILLION OF
SET-ASIDE IN FISCAL 23 BUDGE
TOTE INVESTIGATE EFFECTS OF
TECHNOLOGY AND DIGITAL MEDIA ON
TYPICAL INFANT CHILD AND
ADOLESCENT DEVELOPMENT.
NIMH IS FOCUSED MORE ON EFFECTS
OF SOCIAL MEDIA, HOW IT AFFECTS
MENTAL HEALTH.
SO, WE HAVE GIVEN AWARDS TO
STUDY NOVEL TECHNOLOGY, AND
UNDERSTAND HOW HOW MUCH CHILDREN
ARE EXPOSED TO DIGITAL MEDIA.
BY THE WAY, PARENTS ALWAYS
UNDERESTIMATE HOW MUCH EXPOSURE
THEIR CHILDREN ARE HAVING.
AND WE'RE ALSO LOOKING AT HOW
THE USE OF DIGITAL MEDIA
CORRELATES WITH EMOTIONAL
REGULATION AND SOCIAL COMPETENCE
IN YOUNGER CHILDREN.
IN ADOLESCENTS WE'RE LOOKING AT
RELATIONSHIPS BETWEEN SOCIAL
MEDIA CONTENT, BEHAVIORS, BRAIN
ACTIVITY, HEALTH AND WELL-BEING.
WE RECENTLY HELD A WORKSHOP THAT
WILL BE SUMMARIZED IN
PUBLICATION AND GUIDE RESEARCH
IN THE NEXT COMING YEARS.
NEXT SLIDE PLEASE.
DR. KREGMAN KNOWS WE HAVE THE
NIH PEDIATRIC RESEARCH
CONSORTIUM, WHICH IS ALSO KNOWN
AS N-PeRC.
THAT WAS ESTABLISHED IN 2018
WHEN WE REALIZED MOST OF THE
INSTITUTES AND CENTERS DO HAVE
INTEREST IN CHILD HEALTH
RESEARCH, NICHD IS THE LEAD
FUNDER BUT NOT BY A LOT.
WE FUND 16% OF ALL OF THE CHILD
HEALTH RESEARCH ACROSS NIH.
NHLBI IS RIGHT BEHIND US, FIVE
OR SIX INSTITUTES ARE FUNDING
SIGNIFICANT AMOUNTS OF PEDIATRIC
RESEARCH.
THIS GROUP CONSISTS OF SENIOR
MEMBERS, REPRESENTATIVES FROM
EACH INSTITUTE AND CENTER, WHO
WORK TOGETHER ON AREAS OF
INTEREST TO ALL.
AND SO FAR, WE'VE BEEN WORKING
TOGETHER ON PEDIATRIC PAIN
RESEARCH, AND COLLABORATING AS
PART OF THE HEAL INITIATIVE.
PUBLIC/PRIVATE PARTNERSHIPS
SPECIFICALLY TO DEVELOP
PEDIATRIC MEDICAL DEVICES.
WE HELD A WORKSHOP, AND HAVE A
NOTICE OF SPECIAL INTEREST ON
HOW DO YOU MAKE THAT TRANSITION
FROM ADOLESCENT TO ADULT
HEALTHCARE, PARTICULARLY FOR
PEOPLE WITH CHRONIC DISEASE.
AT THE START OF THE PANDEMIC,
THERE WASN'T A LOT OF INTEREST
IN CHILDREN BECAUSE THE FOCUS
WAS ON OLDER PEOPLE.
SO THE GROUP ACTUALLY GOT
TOGETHER AT THE BEGINNING OF THE
PANDEMIC AND BEGAN TO THINK
ABOUT COMMON DATA ELEMENTS, AND
IMPORTANT TOPICS THAT WERE
AFFECTING CHILDREN, KIND OF WENT
INTO HIGH GEAR, WHEN MIS-C
BECAME A PHENOMENON.
THIS GROUP IS WORKING TOGETHER
TO DEVELOP PEDIATRIC CLINICAL
TRIALS AND ALSO TO EXPAND THE
PEDIATRIC WORKFORCE.
NEXT SLIDE PLEASE.
ANOTHER AREA THAT HAS OCCUPIED
QUITE A BIT OF TIME IS A VISION
FOR PEDIATRIC RESEARCH AT THE
NIH CLINICAL CENTER.
SO, I ALONG WITH BRIGITTE
WIDEMANN CO-LED A GROUP WITH
REPRESENTATIVES ACROSS MULTIPLE
INSTITUTES AND CENTERS TO SEE
WHAT COULD WE DO TO EXPAND
PEDIATRIC RESEARCH AT THE
CLINICAL CENTER.
AND MADE BOTH SCIENTIFIC
RECOMMENDATIONS AS WELL AS
INFRASTRUCTURE RECOMMENDATIONS.
ONE PROBLEM WE WERE TRYING TO
SOLVE WAS THAT IN GENERAL
CHILDREN UNDER AGE 3 CANNOT BE
TREATED AT THE CLINICAL CENTER,
SO THAT LIMITS A LOT OF THE VERY
INNOVATIVE GENE THERAPY WHICH
NEEDS TO BE DONE AS EARLY AS
POSSIBLE IN LIFE.
SOME CAR T THERAPY OPTIONS, AND
SO WE WERE TRYING TO GET AT WHAT
WOULD WE NEED TO BE ABLE TO
EXPAND THAT AND TRULY MAKE THE
CLINICAL CENTER A HOUSE OF HOPE
FOR PEOPLE OF ALL AGES.
WE HAVE A SERIES OF
RECOMMENDATIONS, SOME OF WHICH
REALLY HAVE VERY LITTLE COST
IMPLICATIONS, SO WE'RE TRYING TO
IMPLEMENT SOME OF THESE, AND
IMPORTANTLY AT THE VERY LEAST
IDENTIFY A REGISTRY OF
OPPORTUNITIES OF PEOPLE DOING
PEDIATRIC RESEARCH SO THAT WE
CAN BRING IN EITHER TRAINEES OR
YOUNG INVESTIGATORS FROM THE
OUTSIDE TO BEGIN TO WORK ON
PEDIATRIC TOPICS.
NEXT SLIDE PLEASE.
REHABILITATION, NEXT SLIDE.
SO AS I MENTIONED, WE'RE THE
HOME OF THE NATIONAL CENTER FOR
MEDICAL REHABILITATION RESEARCH.
THIS REALLY IS A VERY BROAD AREA
WHICH ALSO RECENTLY HAD A
STRATEGIC PLAN.
THIS IS AIMED TOWARDS ENHANCING
THE LIFE PRODUCTIVITY,
INDEPENDENCE AND QUALITY OF LIFE
FOR PEOPLE WITH DISABILITIES,
PHYSICAL DISABILITIES.
IT COLLABORATES WITH MANY OTHER
GOVERNMENT AGENCIES AND
ORGANIZATIONS.
NEXT SLIDE.
THESE ARE SOME OF THEIR
PRIORITIES.
THEY SUPPORT FULL RANGE OF
REHABILITATION RESEARCH IN
ADULTS AND CHILDREN INCLUDING
ADAPTATION, PLASTICITY, DEVICE
AND TECHNOLOGY DEVELOPMENT,
REHABILITATION DIAGNOSIS,
ENVIRONMENTAL FACTORS, ET
CETERA.
AND THIS IS VERY IMPORTANT
BECAUSE, YOU KNOW, THERE'S BEEN
A LOT OF INTEREST RECENTLY ON
ABLEISM IN MEDICINE, AND TRYING
TO MAKE PEOPLE AWARE OF ABLEISM
AND HOW IT'S A BARRIER TO CARE
AND HOW IT CONTRIBUTES TO HEALTH
DISPARITIES.
SO DISABILITIES WERE RECENTLY
INCLUDED AS ANOTHER MINORITY
GROUP THAT EXPERIENCES HEALTH
DISPARITIES.
SO THIS IS AN AREA WHERE NICHD
IS VERY ACTIVELY INVOLVED AS
WELL.
NEXT SLIDE.
SO I MENTIONED AT THE BEGINNING
THAT WE'RE VERY INVOLVED IN SOME
OF THESE CROSS-NIH-WIDE
PROGRAMS, WHICH IS THE FOCUS OF
THE COUNCIL OF COUNCILS.
AND BECAUSE OF THE SERIOUS ISSUE
OF MATERNAL MORBIDITY AND
MORTALITY, WHICH IS EXCESSIVE,
CONSIDERING WHERE WE ARE
ECONOMICALLY, IN TERMS OF OUR
COUNTRY, WE'VE BEEN GRATEFUL IN
THIS YEAR'S BUDGET WE RECEIVED A
$40 MILLION APPROPRIATION FROM
CONGRESS TO CONTINUE THE
"IMPROVE" INITIATIVE.
IMPLEMENTING MATERNAL HEALTH AND
PREGNANCY OUTCOMES VISION FOR
EVERYONE, CO-LED BY NICHD,
NURSING INSTITUTE, OFFICE FOR
RESEARCH ON WOMEN'S HEALTH.
OUR GOALS ARE TO REDUCE
PREVENTIBLE CAUSES OF MATERNAL
MORBIDITY AND MORTALITY,
INCREASE LOCAL COMMUNITY
INVOLVEMENT TO DEVELOP LOCAL
SOLUTIONS, TO DO IMPLEMENTATION
RESEARCH TO MAKE A MEASURABLE
DIFFERENCE IN THE RATES OF
MORTALITY, AND TO ADDRESS
HEALTHCARE DISPARITIES, IN
PARTICULAR MATERNITY CARE
DESERTS.
NEXT SLIDE PLEASE.
I'M TRYING TO TALK ABOUT -- I
DON'T HAVE TIME TO TALK IN GREAT
DETAIL BUT SET UP TEN RESEARCH
CENTERS OF EXCELLENCE WITH
PARTNERSHIPS IN MANY AREAS OF
UNDERSERVED POPULATIONS.
WE HAVE ANOTHER CHALLENGE, SO
THIS IS THE CHALLENGE THAT IS
ONGOING RIGHT NOW, TO DEVELOP
NEW DIAGNOSTICS THAT COULD BE
APPLIED POSTPARTUM.
BECAUSE 60% OF MATERNAL DEATHS
OCCUR POSTPARTUM.
AND THERE'S A MAJOR NEED TO
IDENTIFY WOMEN WHO ARE AT RISK
OF SERIOUS COMPLICATIONS OR
DYING PARTICULARLY IF THEY LIVE
IN A MATERNITY CARE DESERT.
WE'RE ALSO TRYING TO EXPAND THE
KNOWLEDGE AND CAPABILITIES OF
LOCAL COMMUNITIES IN TERMS OF
DEVELOPING A RESEARCH
INFRASTRUCTURE.
AND GETTING THEM TO PARTNER IN
TERMS OF IMPLEMENTATION
RESEARCH.
LASTLY, IT'S VERY IMPORTANT TO
DEVELOP ELECTRONIC HEALTH CARE
RECORD STANDARDS FOR PREGNANCY
AND TO LINK THEM WITH THE MOTHER
POSTPARTUM AS WELL AS LINKING
WITH THE BABY TO ENABLE REAL
WORLD RESEARCH.
NEXT SLIDE PLEASE.
I MENTIONED INCLUDE AT THE
BEGINNING, LAUNCHED IN 2018, TO
ADVANCE THE QUALITY OF LIFE FOR
PEOPLE WITH DOWN SYNDROME.
AND IT'S UNIQUE IN THAT IT IS
INVESTIGATING CONDITIONS THAT
ARE BOTH MORE COMMON IN PEOPLE
WITH DOWN SYNDROME, SUCH AS
ALZHEIMER'S DISEASE, AND
CONDITIONS THAT ARE MUCH RARER
IN PEOPLE WHO HAVE DOWN
SYNDROME, SUCH AS MYOCARDIAL
INFARCTION.
AND IT ALSO HAS ALREADY
SIGNIFICANTLY INCREASED THE
NUMBER OF INVESTIGATORS AND
TRAINEES WHO ARE DOING RESEARCH
IN DOWN SYNDROME.
AS WELL AS INCREASING
PARTICIPATION IN RESEARCH ON THE
BASIS OF PEOPLE FROM DIVERSE
BACKGROUNDS.
THIS IS A PROGRAM THAT HAS
REALLY ENJOYED SIGNIFICANT
SUPPORT FROM CONGRESS AND IT HAS
THREE PARTS TO IT.
HIGH RISK, HIGH REWARD, BASIC
SCIENCE STUDIES, RATHER THAN
EXCLUDING PEOPLE WHO HAVE DOWN
SYNDROME FROM RESEARCH IT'S
INCLUDING, SO IT'S A PUN,
INCLUDE, INCLUDING PEOPLE WITH
DOWN SYNDROME IN RESEARCH AND
THEN THERE ARE ALREADY 13
ONGOING CLINICAL TRIALS THAT ARE
ADDRESSING ISSUES SUCH AS CAN
SLEEP APNEA STUDIES BE DONE AT
LOMB, HOW DO YOU TREAT
AUTOIMMUNE DISEASES MORE COMMON
IN PEOPLE WITH DOWN SYNDROME, SO
WE ARE ALREADY IMPROVING LIVES
OF PEOPLE WITH DOWN SYNDROME.
NEXT SLIDE.
SO THESE ARE SOME EXAMPLES, I'M
GOING TO KEEP GOING.
NEXT SLIDE.
SO I HAVE TIME.
THESE ARE THE EXAMPLES I
MENTIONED.
NEXT SLIDE.
WE'VE DEVELOPED NEW RESOURCES,
SO WE HAVE A NEW DATA HUB THAT
IS ENCOURAGING COLLABORATION.
IT HAS 74 TERABYTES OF DATA IN
TERMS OF CLINICAL PROFILES,
GENOMES, TRANSCRIPTOMES,
PROTEOME, METABOLOMES.
MY OWN LABORATORY TARA ALLUDED
TO AT THE BEGINNING, WE'RE
STUDYING SEVERAL MODEL, ANIMAL
MODELS OF DOWN SYNDROME, I'M
VERY EXCITED THAT DATA HUB FOR
THE MANY ANIMAL MODELS OF DOWN
SYNDROME WILL BE COMING OUT SOON
SO WE WILL BE ABLE TO UNDERSTAND
SOME OF THE DIFFERENCES THAT
EXIST IN THOSE MODELS, AND MAYBE
CUSTOMIZE DIFFERENT MODELS FOR
DIFFERENT APPLICATIONS.
WE'RE PARTICULARLY INTERESTED IN
PRENATAL PHENOTYPE OF THESE
ANIMALS.
NEXT SLIDE.
AND I BRIEFLY MENTIONED "HEAL"
AS WELL.
ONE OF OUR MOST SUCCESSFUL
CLINICAL TRIALS IN THE LAST FEW
YEARS HAS BEEN THE ACT NOW
STUDY, IN WHICH A LESS INVASIVE,
MORE FAMILY-ORIENTED APPROACH TO
TREATING BABIES WHO ARE
WITHDRAWING FROM EXPOSURE TO
OPIOIDS IN THE WOMB WAS COMPARED
TO THE TYPICAL STANDARD OF CARE
IN A PARTICULAR HOSPITAL.
AND THE RESULTS SHOWED THAT THE
BABIES WERE MEDICALLY READY FOR
DISCHARGE OVER A WEEK EARLIER
THAN WITH STANDARD OF CARE, AND
THEY USED MUCH LESS MEDICATION.
SO, THAT IS BEING INCORPORATED
INTO STANDARD OF CARE ACROSS THE
COUNTRY.
AND THEN THERE ARE SOME OTHER
ONGOING STUDIES.
WELL, PRESCRIPTION AFTER
CESAREAN TRIAL WAS AIMED AT
LOOKING AT DOES EVERYONE NEED AN
ENORMOUS SUPPLY OF OPIOIDS TO
RECOVER FROM A CESAREAN SECTION,
OR COULD THEY ONLY USE PAIN
MEDICATION AS NEEDED, ET CETERA.
NEXT SLIDE.
SO IN SUMMARY, AND I SEE THAT
THERE'S ALREADY A QUESTION, I
WANTED TO GIVE YOU A SENSE OF
THE VERY BROAD PORTFOLIO.
IT'S BROAD BUT IT'S FOCUSED IN
CERTAIN AREAS.
WE HAVE OUR KEY POPULATIONS,
PREGNANT AND LACTATING PEOPLE,
REALLY IT'S PEOPLE OF
REPRODUCTIVE AGE BECAUSE IT'S
NOT JUST FOCUSED ON PREGNANCY.
IT'S ACROSS THE REPRODUCTIVE
SPECTRUM, BOTH MALES AND
FEMALES.
CHILDREN AND PEOPLE WITH
PHYSICAL AND INTELLECTUAL
DISABILITIES.
WE LEAD RESEARCH ON GYNECOLOGIC
HEALTH, THE PLACENTA IS OUR
ORGAN.
MATERNAL HEALTH, CHILD
DEVELOPMENT AND INTELLECTUAL
DISABILITIES, AND WE ENJOY
PARTNERSHIP WITH MANY OTHER
INSTITUTES, CENTERS, AND
OFFICES, WHO CAN HELP US FURTHER
OUR MISSION AND ENABLE
SCIENTIFIC DISCOVERIES.
SO I THINK THAT'S IT.
AND I'M ABLE TO TAKE SOME
QUESTIONS.
NEXT SLIDE PLEASE.
WE CAN BRING THE SLIDES DOWN.
>> THANK YOU SO MUCH, DIANA.
YES, I EXPECTED NOTHING LESS
THAN TO SEE RICHARD'S HAND UP
RIGHT NOW.
RICHARD, WHY DON'T I TURN IT
OVER TO YOU TO ASK YOUR QUESTION
OR MAKE YOUR COMMENT.
>> THANKS VERY MUCH, DIANA.
NICE TO SEE YOU, ALBEIT
VIRTUALLY.
I REMEMBER THE DAY WHEN YOU
SHOWED UP AT THAT NOVEMBER NICHD
MEETING.
IT'S EXCITING TO SEE THE
PROGRESS OVER THESE YEARS.
IT'S HARD TO BELIEVE THAT IT'S
ACTUALLY THAT MANY YEARS AGO.
I WANTED TO CONGRATULATE YOU,
AND EVERYONE ELSE, WHO HAS
RESPONDED TO THE EFFORTS AROUND
DOWN SYNDROME.
I HAPPEN TO BE ON THE BOARD OF
THE GLOBAL DOWN SYNDROME
FOUNDATION, BACK WHEN IT STARTED
HERE IN DENVER, AROUND 2009.
AND THERE WAS ABOUT $15 MILLION
THAT WAS BEING SPENT ON DOWN
SYNDROME FUNDING.
AND TO SEE THE GROWTH AND
DEVELOPMENT OF THAT FUNDING AND
WHAT IT'S DONE IS TERRIFIC.
I WOULD ALSO LOVE TO SEE, AS YOU
GO INTO YOUR NEXT FIVE YEARS, OF
STRATEGIC PLANNING, A SIMILAR
KIND OF EFFORT IN THE AREA OF
PHYSICAL AND SEXUAL ABUSE AND
OTHER ADVERSE EXPERIENCES THAT
CHILDREN HAVE THAT WE NOW KNOW A
LOT MORE ABOUT THAN WE DID EIGHT
YEARS AGO, OF THAT IMPACT ON THE
THINGS THAT WE'RE ADDRESSING
PIECEMEAL, LIKE OBESITY AND
EATING DISORDERS AND SUICIDE AND
SUBSTANCE USE AND THE REST.
WE STILL HAVE A HUGE GAP IN THAT
AREA.
AND THE MORTALITY OF CHILDREN
WHO DIE OF PHYSICAL ABUSE IS
UNCHANGED IN 40 YEARS.
AND IT WOULD BE NICE TO SEE SOME
PROGRESS IN THAT AREA.
BUT THAT'S ALL.
I DON'T HAVE A QUESTION.
IT'S JUST I DON'T SIT ON YOUR
COUNCIL ANYMORE SO I CAN'T
WHINE.
>> SO FIRST OF ALL, THANK YOU
FOR YOUR SERVICE ON OUR COUNCI.
WE'LL BE HAVING A REQUEST FOR
INFORMATION IN THE NEXT FEW
MONTHS, I WILL INCORPORATE
INCLUDE YOUR COMMENTS IN
STRATEGIC PLANNING MEETINGS.
WE'RE THINKING ABOUT TRAUMA OF
ALL KINDS, NOT ONLY PHYSICAL AND
SEXUAL, BUT I TOTALLY AGREE WITH
YOU THAT THOSE KINDS OF TRAUMAS
REALLY UNDERLIE OTHER
CONDITIONS.
AND WE MAY NOT KNOW WHY SOMEONE
IS MASSIVELY OBESE OR HAVING
MENTAL HEALTH ISSUES, UNLESS WE
ADDRESS THOSE UNDERLYING ISSUES.
I TOTALLY AGREE IT'S SUPER
IMPORTANT TO INCLUDE THAT AND
ENCOURAGE YOU TO RESPOND TO THE
RFI.
I WANT TO THANK ADVOCACY OF
GLOBAL DOWN SYNDROME FOUNDATION
FOR -- MICHELLE WITTEN IS
TIRELESS IN TERMS OF TALKING
WITH MEMBERS OF CONGRESS, MAKING
THE WORK KNOWN.
AS SOMEONE, BOTH CLINICS AND
RESEARCHERS IN DOWN SYNDROME
FIELD, IT'S REALLY UNBELIEVABLE
TO SEE WHAT THAT MONEY HAS DONE.
YOU KNOW, WHEN YOU GO TO THE
TRISOMY 21 RESEARCH MEETINGS,
THE NEXT ONE IS NEXT WEEK
ACTUALLY, BUT WHEN YOU SEE THE
POPULATIONS OF POSTDOCS OR
GRADUATE STUDENTS WHO REALLY SEE
THIS AS A VIABLE FIELD NOW, IT'S
AMAZING.
AND THE FACT THAT IT'S
TRANSLATED TO ACTUAL MEASURABLE
IMPROVEMENTS IN THE LIVES OF
PEOPLE WITH DOWN SYNDROME, IT
SHOWS YOU WHAT CAN BE DONE WITH
FUNDING.
>> GREAT.
IT'S A REALLY AMAZING PROGRAM.
ALL RIGHT.
I KNOW MONICA HAD A QUESTION AND
THEN KENT HAD SOMETHING IN THE
CHAT.
WE'LL TURN IT TO MONICA FIRST.
>> THANK YOU SO MUCH FOR THAT
PRESENTATION.
THAT WAS REALLY GREAT.
I WANTED TO TURN TO HIV FOR A
MINUTE BECAUSE NICHD IS PIVOTAL
AND HAS BEEN FOR THE WOMEN TO
FETAL TRANSMISSION STUDIES AND
PEDIATRIC HIV, BUT IT'S SO
UNDERFUNDED IN THE SENSE THAT
CHILDREN LIVING WITH HIV
WORLDWIDE, THE GROUP THAT'S
DOING THE LEAST WELL IN TERMS OF
ACCESS TO ANTIRETROVIRAL
THERAPY, SUPPRESSION RATES.
I WANTED TO SEE IF YOU THINK
THERE'S A POSSIBILITY OF
REDIRECTING MORE RESERVES INTO
HIV AND PEDIATRIC HIV, GIVEN HOW
ONLY NICHD KIND OF HAS THAT
PURVIEW, THAT'S ONE QUESTION.
AND THEN I THINK THAT NICHD HAS
REALLY PUSHED THE ENVELOPE IN
TERMS OF STUDYING HIV DRUGS AND
PREGNANCY, WHY THAT FIELD SHOWED
US WE SHOULD BE JUSTIFYING
EXCLUSION RATHER THAN INCLUSION
OF PREGNANT WOMEN.
>> RIGHT.
WELL, THANK YOU FOR YOUR
QUESTION, DR. GANDHI.
YOU KNOW, WE'RE FORTUNATE IN
THAT MUCH OF OUR HIV PORTFOLIO
IS FUNDED BY THE OFFICE OF AIDS
RESEARCH AT NIH.
WE TYPICALLY PUT FORWARD
WHATEVER WE CAN, AND IN GENERAL
THEY ARE VERY GENEROUS IN
FUNDING US, IF IT IS MAINLY OR
ALMOST EXCLUSIVELY AFFECTING
POPULATIONS WITH HIV.
I MEAN, WE HAVE A NUMBER OF
PARTICULARLY INTERNATIONAL
GROUPS THAT ARE STUDYING WOMEN
AND INFANTS WITH HIV, AND IN
FACT, YOU KNOW, IN KENYA, I WENT
TO KENYA A NUMBER OF YEARS AGO
TO MEET WITH OUR INVESTIGATORS
WHO ALMOST ALL WERE BEING FUNDED
TO DO HIV, PERINATAL AND
MATERNAL STUDIES.
THAT BEING SAID, IN THE UNITED
STATES WE HAVE A BIG ISSUE,
GROWTH OF HIV, PARTICULARLY
YOUNG MEN HAVING SEX WITH YOUNG
MEN.
THAT'S A REAL CHALLENGE FOR US
STILL.
AND IT'S BEEN IDENTIFIED AS
SUCH.
SO, YOU KNOW, WE TRY TO USE
RESOURCES THAT ARE AVAILABLE TO
US, AND WORK WITH OFFICE OF AIDS
RESEARCH TO SHOW THEM EVERYTHING
THAT WE'RE DOING.
AND, YOU KNOW, SURE, WE CAN DO
MORE.
>> AND THE REP THAT NICHD HAS TO
OAR IS REALLY ACTIVE, VERY MUCH
A LEADER IN THAT AREA ACROSS ALL
OF NIH AND OF COURSE WE'RE IN
THE PROCESS OF SEARCHING FOR A
NEW OAR DIRECTOR, WE CAN HAVE
MORE DISCUSSIONS ON THIS,
MONICA, DOWN THE ROAD.
>> YEAH.
>> PERSON ON BOARD.
>> GREAT, THANK YOU SO MUCH.
>> DR. LLOYD HAD A QUESTION AND
THEN DR. KING.
>> YEP.
>> VERY QUICKLY, THANKS VERY
MUCH FOR THE PRESENTATION.
I THOUGHT I KNEW SO MUCH, BUT I
REALIZE AFTER HEARING YOU TALK
HOW LITTLE I KNEW ABOUT NICHD,
IMPRESSED WITH THE STRENGTH AND
BREADTH.
IF I MISSED, FORGIVE ME, WHAT
INTERACTION DO YOU HAVE WITH THE
"ALL OF US" PROGRAM IN TERMS OF
GROWING CHILDREN AND YOUNG
ADULTS?
>> YEAH, GREAT QUESTION.
SO, I'VE BEEN INVOLVED ON THE
STEERING COMMITTEE FOR "ALL OF
US" FOR ALMOST ALL THE TIME I'VE
BEEN HERE AND DURING THAT TIME
WE'VE ASKED EVERY YEAR WHEN ARE
CHILDREN GOING TO BE INCLUDED.
AND THEY HAVE MADE PARTICULARLY
THE LAST COUPLE YEARS SINCE THE
RECRUITMENT OF SARAH VAN DREYS,
A PEDIATRICIAN, THE LEAD
PEDIATRICS ON "ALL OF US," THEY
MADE A LOT OF PROGRESS IN TERMS
OF DEVELOPING AND INFRASTRUCTURE
THAT WILL ALLOW FOR RECRUITMENT
OF CHILDREN STARTING WITH
YOUNGER CHILDREN BORN TO WOMEN
ALREADY ENROLLED IN "ALL OF US"
BECAUSE THERE ARE A LOT OF
PREGNANT WOMEN IN "ALL OF US."
THAT'S THE GOOD NEWS.
THE BAD NEWS IS THE "ALL OF US"
PROGRAM TOOK A SIGNIFICANT, I
MEAN MAJOR, $184 MILLION HIT IN
TERMS OF THEIR BUDGET, JUST A
DEVASTATING CUT, AT A TIME --
YEAH, 34%, AT A TIME WHEN THEY
WERE JUST STARTING TO RECRUIT
CHILDREN.
SO, THEY ARE LOOKING FOR SOME
SUPPORT FROM OTHER INSTITUTES
AND CENTERS TO TRY TO KEEP AS
MUCH OF THE PROGRAM GOING.
WE'RE HOPING TO BE ABLE TO
SUPPORT THEM TO MAINTAIN AT
LEAST A COUPLE CENTERS THAT ARE
ALREADY DIALED UP AND READY TO
GO.
THEY MAY NOT BE ABLE TO HAVE AS
MANY AS THEY THOUGHT THEY COULD,
BUT WE THINK IT'S REALLY
IMPORTANT NOT TO LOSE MOMENTUM
BECAUSE WE'VE BEEN WAITING FOR
SO LONG TO GET KIDS INTO "ALL OF
US."
YOU'RE RIGHT, YOU DIDN'T MISS
IT.
I DIDN'T HAVE TIME TO INCLUDE
IT.
>> IT'S STILL ONE OF THE TOP
PRIORITIES FOR THE PROGRAM, JUST
THE BUDGET CHALLENGES ARE A
MAJOR ISSUE RIGHT NOW.
JEAN, YOU ARE OUR LAST QUESTION.
>> OKAY.
THANK YOU.
THANK YOU FOR THE PRESENTATION.
SO MY CONCERN, I KNOW YOU
MENTIONED DISPARITIES, HEALTH
DISPARITIES IN PREGNANCY.
I THINK WE ALL KNOW FROM THE CDC
AND OTHER PLACES THAT BLACK
WOMEN ARE THREE TIMES MORE
LIKELY TO DIE OF
PREGNANCY-RELATED CAUSES THAN
WHITE WOMEN.
AND THAT'S WORSE THAN MANY THIRD
WORLD COUNTRIES.
I CANNOT -- I STILL CAN'T REALLY
SORT OF UNDERSTAND WHY WE'RE NOT
DOING MORE RESEARCH TO TRY TO
FIGURE OUT WAYS THAT WE COULD
HELP.
WE'RE LOSING A WHOLE GENERATION
OF PEOPLE THROUGH THESE REASONS
THAT ARE I THINK WE HAD SOLVED
FOR MANY YEARS, DOESN'T MATTER
SES OF BLACK WOMEN, IF SHE'S
COLLEGE EDUCATED, SO IT'S NOT
SOME OF THE THINGS WE MAY THINK
ABOUT THAT IS JUST AROUND
POVERTY.
YES, POVERTY PLAYS A ROLE BUT
THERE'S SO MANY THINGS WE DON'T
UNDERSTAND, WHY WOMEN WHO ARE
COLLEGE EDUCATED, IN SES BRACKET
WE WOULDN'T EXPECT THIS TO BE
HAPPENING AT THIS LEVEL.
SO I'M NOT SURE WHICH AGENCIES
HAD HELPING, HOW YOU'RE THINKING
ABOUT, NOT SOMETHING YOU CAN
SOLVE ALONE BUT IS THERE ANY WAY
WE CAN HELP AS A COUNCIL TO DRAW
ATTENTION TO FORCES THAT
CONTINUE TO REALLY RAGE IN OUR
COMMUNITIES?
>> YEAH, I AGREE 100%.
I OFTEN FRAME IT AS THE SERENA
WILLIAMS PROBLEM.
SERENA WILLIAMS IS WELL
EDUCATED, WEALTHY, INTERNATIONAL
SUPERSTAR, AND YET HER CARE
PROVIDERS DIDN'T LISTEN TO HER
WHEN SHE SAID I CAN'T BREATHE,
AND I KNOW I'VE HAD BLOOD CLOTS
BEFORE AND KNOW WHAT THAT FEELS
LIKE.
AND YET THEY STILL DIDN'T LISTEN
TO HER.
IF THAT CAN HAPPEN TO SERENA
WILLIAMS, IT CAN HAPPEN TO
ANYBODY.
THERE'S NO DOUBT THAT BLACK
WOMEN AND AMERICAN INDIANS AND
ALASKA NATIVE WOMEN ARE ALSO
EXPERIENCING INCREASED RATES OF
MORTALITY COMPARED TO WHITE
WOMEN AND HISPANIC WOMEN.
I DIDN'T HAVE TIME TO GO INTO
ALL THE DETAILS.
I'M HAPPY TO COME BACK AT A
FUTURE TIME TO TALK ABOUT THE
"IMPROVE" INITIATIVE.
BUT THERE ARE SPECIFIC ASPECTS
IN THE CENTERS OF EXCELLENCE,
FOR EXAMPLE, TRYING TO ADDRESS
THE SOCIAL AND BEHAVIORAL
ASPECTS, HOW MUCH DOES RACISM
PLAY A ROLE, HOW MUCH DOES
WEATHERING PLAY A ROLE IN THIS?
THIS IS PART OF THE REASON WHY
IT'S SO IMPORTANT TO HAVE THE
COMMUNITY INVOLVEMENT, BECAUSE
IT'S ONE THING FOR A WHITE
PHYSICIAN, ACADEMIC MEDICAL
CENTER, TO SAY SOMETHING TO A
PREGNANT PERSON OF COLOR BUT
IT'S ANOTHER THING IF YOU TRAIN
PEOPLE IN THE COMMUNITY AND
THERE'S A COMMUNITY EFFORT TO
INVOLVE DOULAS, FOR EXAMPLE, OR
TO INVOLVE CARE PROVIDERS WHO
MAY NOT BE PHYSICIANS BUT WHO
ARE FAMILIAR WITH THE CULTURE
AND PRACTICE IN THAT COMMUNITY.
SO, WE ARE VERY AWARE OF THE
DISPARITIES.
IT'S NOT JUST AN ACCESS ISSUE,
ALTHOUGH ACCESS IS EXTREMELY
IMPORTANT HERE, BECAUSE THERE
ARE TWO MILLION PREGNANT WOMEN
WHO ARE LIVING IN MATERNITY CARE
DESERTS, AND THESE ARE BOTH
RURAL AND URBAN AREAS.
BUT WHEN WE SAY MATERNITY CARE
DESERT, THERE'S NOT ONE
OBSTETRICIAN IN THEIR COUNTY.
SO, I RECENTLY SPOKE AT A
CONGRESSIONAL BRIEFING WITH A
PROVIDER, OBSTETRICIAN FROM
GEORGIA, SHE'S COVERING TWO
COUNTIES IN GEORGIA.
SHE'S THE ONLY OBSTETRICIAN.
AND IT'S NOT JUST THE CARE.
IT'S TRANSPORT.
IN MANY OF THESE RURAL
COMMUNITIES, WE CAN DEVELOP A
DEVICE THAT'S GOING TO SAY
SOMEONE IS AT RISK FOR
HEMORRHAGE, BUT WE'VE GOT TO GET
THEM OUT OF THAT COMMUNITY TO BE
ABLE TO BE TREATED.
AND I'VE LEARNED INCREASINGLY
OVER THE LAST FEW MONTHS WHAT A
CHALLENGE THAT IS.
SO IT'S A VERY COMPLEX PROBLEM,
ALL I CAN DO NOW IS ASSURE YOU
THAT IT IS A MAJOR FOCUS OF THE
"IMPROVE" INITIATIVE TO ADDRESS
DISPARITIES.
YOU KNOW, TO BEGIN TO BRING
OVERALL NUMBERS DOWN BUT
PARTICULARLY IN COMMUNITIES OF
COLOR.
>> THANKS SO MUCH, DIANA.
OBVIOUSLY SUCH AN IMPORTANT
TOPIC, AND A LOT MORE WORK THAT
WE AND OTHER AGENCIES AND
ORGANIZATIONS AND PARTNERS
ACROSS THE U.S. NEED TO SPEND
MORE EFFORT ON.
REALLY APPRECIATE YOU THINKING
OF SPENDING EFFORT, SPENDING
TIME WITH US TODAY TO TALK ALL
OF THE WIDE VARIETY OF THINGS
NICHD IS DOING AND MIGHT TAKE
YOU UP ON THE OFFER TO COME BACK
AND TALK ABOUT IMPROVE IN MORE
DETAIL AT FUTURE COUNCIL
MEETING.
>> GREAT.
THANKS FOR THE INVITATION.
TAKE CARE.
>> ALL RIGHT.
NOW WE'RE GOING TO TRANSITION TO
OUR NEXT TOPIC, A CONCEPT
CLEARANCE FOR.
AND SUSAN GREGURICK AND LAWYER
BIVEN FROM ODDS AND CHRISTINE
CUTILLO WILL TALK ABOUT
PREPARING THE NEXT GENERATION OF
BIOMEDICAL RESEARCH TEAMS FOR
ETHICAL A.I. WORKFORCE AND
CURRICULA DEVELOPMENT, THIS IS A
REALLY CRITICAL AREA OBVIOUSLY
THAT WE NEED TO DO MORE IN.
AND HELP TO UNDERSTAND THIS IS A
FAST-EVOLVING FIELD.
SO WITH THAT, I WILL TURN IT
OVER TO SUSAN, LAURA, AND
CHRISTINE, AND THEN WE'RE GOING
TO HAVE COMMENTS FROM TWO
DISCUSSANTS.
>> THANK YOU FOR ALLOWING US TO
PRESENT OTHER CONCEPT CLEARANCE
TO PREPARE THE NEXT GENERATION
OF BIOMEDICAL RESEARCH TEAMS FOR
ETHICAL A.I.
I'M THE ASSOCIATE DIRECTOR OF
DATA SCIENCE, LEAD OF OFFICE OF
SCIENCE STRATEGY, JOINED BY DR.
LAURA BIVEN, AND PROGRAM LEAD
FOR PROGRAM, CHRISTINA CUTILLO,
JUST JOINED ODSS, JOINED THIS
YEAR.
NEXT SLIDE.
THIS IS A LITTLE BIT OF SOME OF
THE MANY ACTIVITIES THAT NIH IS
ENGAGING IN, ARTIFICIAL
INTELLIGENCE.
AND THIS IS A SMALL SET OF THE
LARGER HHS A.I. ACTIVITIES THAT
ADDRESS THE A.I. EXECUTIVE
ORDER, JUST RECENTLY RELEASED
THIS PAST FALL.
TO REALLY IMPROVE NOT ONLY THE
WORKFORCE OF CITIZENS WHO CAN
USE AND ARE COGNIZANT OF A.I.
AND FRAMEWORKS NEEDED.
WE HAVE CROSS-CUTTING PROGRAMS,
HERE ARE A FEW.
YOU'RE FAMILIAR WITH BRIDGE2AI,
FOR GRAND CHALLENGES, FAMILIAR
WITH THE PROGRAM TO ENHANCE
EQUITY AND CAPACITY IN DIVERSE
COMMUNITIES.
YOU MAY NOT BE FAMILIAR WITH OUR
INITIATIVE TO DRIVE CAPABILITIES
AND DEVELOPMENT IN ARTIFICIAL
INTELLIGENCE, THERE'S A REALLY
GREAT ARTICLE, A SHORT LETTER IN
"SCIENCE," MAY 23, BY ERIC TOPOL
FOR FORECASTING COMMUNITIES, I
RECOMMEND IT.
IT'S A GOOD READ.
AND PROVIDING SUPPORT FOR HEALTH
DISPARITIES AND INTRAMURAL
RESEARCH CENTER FOR ALZHEIMER'S
AND RELATED DEMENTIA, DATA
APPROACHES FOR OUR DEVELOPING
RESEARCH AND ALZHEIMER'S AND
DEMENTIA.
WE'RE ALSO A LEAD AGENCY IN THE
NATIONAL A.I. RESEARCH RESOURCE,
AND CHRISTINE IS OUR PROGRAM
LEAD, WHICH SEEKS TO DEVELOP
NATIONAL SCALE A.I. DATA AND
COMPUTATIONAL RESOURCES FOR
RESEARCHERS ACROSS THE U.S.
EACH OF THESE PROGRAMS AND
COMPONENTS HAS A LITTLE BIT OF
TRAINING AND WORKFORCE ELEMENTS
WITHIN BUT NO FOCUSED INITIATIVE
INCLUDING ALL THE INSTITUTES AND
AND
CENTERS ON A.I. TRAINING,
COMPLEMENT TO EFFORTS WE'RE
SHOWING YOU TODAY.
IT HAS POTENTIAL TO TOUCH MANY
RESEARCHERS ACROSS NIH, WITH
LENS THAT ENCOMPASS THE THE LIFE
CYCLE.
I'LL TURN IT OVER TO LAURA TO
PRESENT THE CONCEPT CLEARANCE
AND PICK BACK UP WITH QUESTIONS
AND ANSWERS.
TO YOU, LAURA.
>> NEXT SLIDE.
BEFORE I DIVE INTO THE DETAILS
OF THE THREE INITIATIVES WE'RE
PUTTING FORWARD I ACKNOWLEDGE WE
HAVE PRESENTED RELATED TOPIC
BEFORE, I THINK IT WAS MAY OF
2021.
AND WE PRESENTED A CONCEPT
CLEARANCE FOR SOMETHING SIMILAR
AIMED AT SORT OF PREPARING THE
BIOMEDICAL WORKFORCE FOR A.I.
REVOLUTION, A.I. RESEARCH
EXPERIENCE.
WE REALLY ENCOURAGE YOU WITH
SOME OF THE FEEDBACK WE GOT.
AT THAT TIME WE WERE PROPOSING
COMPLEX TRAINING CENTERS, SCALED
BACK INTO A PHASED APPROACH,
PUTTING FORWARD FIRST PHASE OF
THAT TODAY.
WE ALSO HEARD YOU WITH THE IDEA
OF FIRST GETTING LANDSCAPE
ASSESSMENT, UNDERSTANDING WHAT
THE STATE IS OF TRAINING AND
DEVELOPMENT.
SOME CORE COMPETENCIES THAT
WE'RE PUTTING FORWARD.
TO DO SOME PILOTS.
WE'VE DONE THAT AS WELL.
I HOPE WE'LL CONVINCE YOU THAT
WHAT WE'RE PUTTING FORWARD IS
MUCH MORE MANAGEABLE, TARGETED
AT SOME OF THE KEY ASPECTS OF
THE WAYS IN WHICH BIOMEDICAL
RESEARCH REALLY CAN IMPACT AND
ALSO BENEFIT FROM A.I.
AND THOSE ARE AROUND THE DATA
THAT ARE CREATED THROUGH
BIOMEDICAL RESEARCH, ALSO
COLLABORATIONS THAT RESEARCHERS
ENGAGE IN.
THE FIRST INITIATIVE IS
MULTI-DISCIPLINARY POSTDOC
PROGRAM FOR ETHICAL A.I. IN
BIOMEDICAL AND BEHAVIORAL
RESEARCH, AN OPPORTUNITY FOR
POSTDOCS TO ENGAGE IN
MULTI-DISCIPLINARY RESEARCH,
MENTORED BY SOMEONE IN THE
BIOMEDICAL DISCIPLINE, ALSO WITH
A.I. EXPERTISE AND ALSO SOMEONE
WITH ETHICS EXPERTISE.
IT'S REALLY IMPORTANT TO HAVE
ALL THREE OF THOSE COMPONENTS IN
THIS RESEARCH ACTIVITY.
WE HEARD THE POSTDOC PHASE IS A
WONDERFUL OPPORTUNITY TO DEVELOP
THESE KINDS OF EXPERTISE IN
BIOMEDICAL RESEARCH COMMUNITY BY
BRINGING IN PEOPLE FROM ALL
DIFFERENT FIELDS AND ALSO FROM
TRAINING THEM IN THIS
MULTI-DISCIPLINARY ASPECT.
WE HAVE A BUDGET THAT WILL BE
GROWING.
WE HOPE TO IN A FEW YEARS HAVE A
STEADY STATE OF SOMETHING LIKE
15 AWARDS PER YEAR.
WE CAN GO TO THE NEXT SLIDE
PLEASE.
NEXT TWO INITIATIVES WE'RE
PUTTING FORWARD ARE AROUND
CURRICULUM DEVELOPMENT TRAINING
AND ASSESSMENT.
AND THE FIRST ONE HERE IS AROUND
UNDERGRADUATE AND GRADUATE
CURRICULUM MODULE OR TRAINING
DEVELOPMENT AND ASSESSMENT FOR
A.I.-READY BIOMEDICAL AND
BEHAVIORAL RESEARCHERS.
SO THIS IS AN OPPORTUNITY TO
DEVELOP NEW TRAINING
OPPORTUNITIES AND CURRICULA THAT
WILL TARGET BIOMEDICAL
RESEARCHERS, PEOPLE WHO WILL
BECOME PART OF OUR BIOMEDICAL
RESEARCH WORKFORCE.
AND REALLY TRAIN THEM UP IN THE
SKILLS AND COMPETENCIES NEEDED
TO CREATE FAIR AND A.I.-READY
DATA, ALSO TO COLLABORATE WITH
A.I. EXPERTS AND WITH ETHICISTS
ON NEW CAPABILITIES IN A.I.
AND SO WE'RE HOPING THAT -- I'LL
TELL YOU MORE DETAILS IN THE
COMING SLIDES.
NEXT SLIDE PLEASE.
THIS NEXT CURRICULUM DEVELOPMENT
INITIATIVE IS FOCUSED NOW ON
PEOPLE WHO WILL BECOME
BIOETHICISTS, ETHICISTS AND
COLLABORATORS WITH US IN A.I.
RESEARCH ACTIVITIES.
WE HEARD THIS VERY STRONGLY FROM
THE RESEARCH COMMUNITY AND
PEOPLE WE ENGAGED WITH, THERE'S
LACK OF EXPER EXPERTISE AT THAT
INTERSECTION.
THIS IS ATTEMPTING TO MEET THAT
NEED.
THERE'S AN OPPORTUNITY HERE TO
DEVELOP NEW CURRICULUM AND
TRAINING OPPORTUNITIES FOR
PEOPLE WHO WILL BE COMING INTO
THIS BIOETHICS WORKFORCE TO
REALLY HELP THEM UNDERSTAND THE
IMPLICATIONS OF ARTIFICIAL
INTELLIGENCE AND DATA IN A.I.
NEXT SLIDE PLEASE.
JUST TO COMPARE AND CONTRAST
SOME OF THE PROGRAMS, ON THE
LEFT-HAND SIDE WE'RE TALKING
ABOUT THE POSTDOC PROGRAM.
HERE WE HOPE TO TARGET A BROAD
POOL OF RESEARCHERS WITH THE
GOAL OF THEM REACHING RESEARCH
INDEPENDENCE IN THIS
MULTI-DISCIPLINARY INTERSECTION
OF FIELDS, AND BIOMEDICINE,
A.I., ETHICS, AND SUPPORT A
PORTFOLIO OF RESEARCH THAT
ADDRESSES THE WHOLE OF THE NIH
WATERFRONT OF MISSION SPACE.
SO WE'LL BE COLLABORATING WITH
OUR I.C. PARTNERS TO MAKE SURE
WE HAVE THAT PORTFOLIO APPROACH.
AND THEN WE HOPE TO SEE AN
UP-AND-COMING GENERATION OF
RESEARCHERS ABLE TO INNOVATE IN
THIS SPACE OF ARTIFICIAL
INTELLIGENCE AND BIOMEDICINE
ETHICS.
ON THE MIDDLE IS THE EFFORT
TARGETING BIOMEDICAL
RESEARCHERS.
WE'LL BE TARGETING THESE SKILLS
AND COMPETENCIES NEEDED TO MAKE
DATA FAIR AND A.I. READY.
SO THEY CAN UNDERSTAND SOME OF
THESE ETHICS CHALLENGES THAT
ARISE IN ARTIFICIAL
INTELLIGENCE.
AND THEY BE BE GOOD
COLLABORATORS IN THE TEAMS THAT
WE'RE IMAGINING.
ON THE RIGHT-HAND SIDE IS THE
EFFORT FOCUSED ON THE TRAINEES
WHO WILL BECOME PART OF THE
BIOETHICS COMMUNITY, AND WE'LL
ENHANCE THE ETHICAL DEVELOPMENT
OF A.I. AND HELP THEM BE GOOD
COLLABORATORS WITH US.
WE'LL SUPPORT A PORTFOLIO IN A
ADDRESSES MANY DATA TYPES AND
HOPE MANY ETHICS CHALLENGES.
SO NOT JUST PRIVACY AND THINKING
ABOUT SECURITY OF DATA BUT IT'S
ALSO THINGS LIKE HOW TO USE
PROXY DATA IN ARTIFICIAL
INTELLIGENCE, UNDERSTAND
UNCERTAINTY AND IMPLICATIONS ON
DIFFERENT COMMUNITIES.
WE HOPE TO BRING THESE TEAMS
TOGETHER AND SO WE HAVE -- NEXT
SLIDE, I'LL TALK ABOUT THAT.
SO, THE APPLICATION REQUIREMENTS
JUST TO UNDERSTAND HOW WE'LL BE
THINKING ABOUT ROLLING THIS OUT,
FOR THE POSTDOC PROGRAM THERE
WILL BE -- APPLICANTS WILL PUT
FORWARD A PROGRAM FOR RESEARCH,
HAVE ONE PRIMARY MENTOR, WE HOPE
THEY WILL ALSO HAVE TEAM OF
MENTORS THAT REALLY WILL GET AT
MULTI-DISCIPLINARY MENTORSHIP
APPROACH, AND COLLABORATION WITH
UNDERREPRESENTED ORGANIZATIONS,
PROJECTS WOULD BENEFIT FROM THE
MULTI-DISCIPLINARY APPROACH TO
IMAGINE THAT MENTORS COULD COME
FROM MULTIPLE INSTITUTIONS.
ON THE RIGHT-HAND SIDE FOR THE
CURRICULUM DEVELOPMENT, THE
PROPOSERS WOULD BE SPECIFYING
TRAINING MATERIALS AND
ACTIVITIES AND SKILLS AND
COMPETENCIES TARGETED, A CLEAR
PLAN FOR FORMATIVE ASSESSMENTS,
HOW TO DISSEMINATE MATERIALS,
THAT COULD BE THE TRAINING
MATERIALS BUT ALSO DATA AND
CODE.
THEY SHOULD HAVE RECRUIT AM PLN
AND TARGET DIFFERENT GROUPS.
SO FUTURE BIOMEDICAL RESEARCHERS
AND FUTURE BIOETHICISTS BUT
WE'LL HOPE TO BRING COHORTS
TOGETHER, OUR PLAN IS TO HAVE
JOINT P.I. MEETINGS, JOINT
MEETINGS FOR TRAINEES, ALSO
WE'RE HOPING TO HAVE AN
OPPORTUNITY WHERE SOME OF THE
AWARDEES CAN THING ABOUT
PRACTICUM OPPORTUNITIES.
NEXT SLIDE PLEASE.
AS WE MENTIONED, THIS IS --
WE'RE THINKING ABOUT A PHASED
APPROACH.
SO FOR THE POSTDOC PROGRAM WE
WANT TO NURTURE A COMMUNITY OF
EXPERTS IN THIS INTERSECTION OF
BIOMEDICINE, ARTIFICIAL
INTELLIGENCE, ETHICS.
AND SO WE'LL BRING THEM TOGETHER
IN P.I. MEETINGS, NOT JUST
AMONGST THEMSELVES BUT ALSO WITH
OTHER PROGRAMS THAT MANY OF
WHICH SUSAN MENTIONED, BRINGING
THEM TOGETHER, INTEGRATING THEM
INTO THE NIH COMMUNITY OF
BIOMEDICAL RESEARCHERS AND ALSO
NURTURING THIS KEY EXPERTISE.
SIMILARLY FOR TRAINING AND
CURRICULUM DEVELOPMENT PROGRAMS,
THIS JUST THE BEGINNING.
DEVELOPING CURRICULUM AND
TRAINING OPPORTUNITIES, WE HOPE
TO THEN ALSO PROVIDE TOOLS AND
INFRASTRUCTURE FOR THE SHARING
OF THOSE OUTPUTS, SO THE
CURRICULUM CAN BE SHARED AND
PICKED UP BY OTHER INSTITUTIONS.
WE ALSO HOPE TO SUPPORT THAT
KIND OF UPTAKE OF THE
CURRICULUM.
SO WE COULD IMAGINE HAVING
FUTURE SOLICITATIONS THAT INVITE
OTHER ORGANIZATIONS TO PICK UP
SOME OF THE CURRICULUM AND
MODULES AND USE THEM.
AND THEN ALSO WE'RE GOING TO
THINK ABOUT THE FUTURE CAREER
PATHS OF TRAINEES.
SO, WE WANT -- WE'RE FOCUSING ON
MAKING SURE THAT THESE SKILLS
ARE TARGETING FUTURE BIOMEDICAL
RESEARCHERS AND BIOETHICISTS BUT
MAKE SURE THERE'S OPPORTUNITIES
FOR THEM AFTERWARDS, WITHIN OUR
RESEARCH COMMUNITY BUT ALSO
PERHAPS WITHIN INDUSTRY OR OTHER
CAREER PATHS.
SO WE'LL BE THINKING ABOUT
PARTNERSHIPS, PERHAPS WITH
INDUSTRY, PERHAPS WITH OTHER
AGENCIES AS WELL.
NEXT SLIDE.
I HAND OFF TO MY COLLEAGUES
CHRISTINE HERE.
>> THANK YOU SO MUCH, LAURA.
TAKING A STEP BACK WE WANT TO
HIGHLIGHT LEARNING FOR LANDSCAPE
ASSESSMENT AND ENGAGEMENT THAT
SHAPE DEVELOPMENT OF THE PROPOSE
THE KNISH -- PROPOSED
INITIATIVES, FIRST TO IDENTIFY
CORE SKILLS AND COMPETENCIES
NEEDED FOR BIOMEDICAL
RESEARCHERS TO MAKE DATA FAIR
AND A.I. READY.
LANDSCAPE ANALYSIS WAS PERFORMED
TO UNDERSTAND RECOMMENDATIONS
FROM RESEARCHERS THEMSELVES
WORKING AT THE FOREFRONT OF
BIOMEDICAL A.I.
INCLUDING COMPETENCIES NEEDED TO
GENERATE, HANDLE, PROCESS,
STORE, AND SHARE FAIR AND
A.I.-READY BIOMEDICAL DATA.
THE SKILLS IDENTIFIED TO FURTHER
THIS OVERARCHING GOAL MAKING
BIOMEDICAL RESEARCH DATA READY
INCLUDE FIVE COMPETENCIES,
DATASET DOCUMENTATION, ONTOLOGY,
DATA ENCODING, DOWN TO REUSE OF
EXISTING DATASETS.
A NOTE ETHICS WAS INITIALLY
IDENTIFIED AS A SEPARATE SKILL,
BUT THROUGH THE PROCESS NEED FOR
ETHICS TO BE EMBEDDED IN EACH,
DEFINED AS ETHICS FIRST
COMPETENCIES.
THESE SKILLS ARE A GOOD START
BUT NOT NECESSARILY RESTRICTIVE.
WE HOPE TO LEARN MORE ABOUT THIS
THROUGH THESE PROPOSED
SOLICITATIONS.
WE DID LEARN HOWEVER CURRENT
TRAININGS MAY ADDRESS ONE OR TWO
OF THESE BUT ADDRESSING DATA
CREATION, COLLECTION,
PREPARATION WITH THE VIEW OF
REUSE AND A.I.
AND WE ALSO LEARNED THERE'S A
GAP IN TRAINING WITH
DISCIPLINARY FOCUS, TRAINEES
WANT TO LEARN ABOUT FOR EXAMPLE
ONTOLOGY THAT RELATE TO
BIOMEDICAL INTERESTS OR
OPPORTUNITIES TO MAKE THEIR DATA
A.I. READY.
THESE WERE NOT IMBUED INTO
EXISTING OPPORTUNITIES.
NEXT SLIDE.
FOR THREE YEARS ODSS SPONSORED
SEVERAL SUPPLEMENTAL FUNDING
OPPORTUNITIES FOCUSED ON
TRAINING, ETHICS, AND DATA.
WE HAD TREMENDOUS INTEREST
ACROSS NIH, AND INSTITUTES THAT
PARTNERED WITH SHOWN ON THIS
SLIDE.
WE ALSO HAD A ROBUST RESPONSE IN
RESEARCH AND EDUCATION COMMUNITY
WITH NUMBER OF AWARDS SHOWN
HERE.
I'M GOING TO DESCRIBE MORE ABOUT
THE FEEDBACK WE RECEIVED FROM
THESE COHORTS IN A FEW SLIDES.
FIRST I'M GOING TO DELVE INTO A
EXAMPLES FROM EACH OF THOSE.
NEXT SLIDE.
THIS SHOWS HIGHLIGHTS, A
PRECURSOR FOR THIS INITIATIVE.
THIS OPPORTUNITY INVITED
EXISTING TRAINING CENTERS TO
DEVELOP NEW CURRICULA OR
TRAINING OPPORTUNITIES FOR
MAKING DATA FAIR AND A.I. READY.
FIRST HIGHLIGHT COMES FROM
UNC-CHAPEL HILL RESULTING IN A
TOOL KIT TO PROMOTE
TRAINEE-DRIVEN DATA GENERATION,
MANAGEMENT, ANNUAL SILLS
METHODS.
SPECIFIC TO ENVIRONMENTAL HEALTH
DATA AND ADDRESS GAPS IN
TRAINING AND CODING.
SECOND IN THE MIDDLE COMES FROM
MOFFITT CANCER CENTER, READING
PRINCIPLES WITH FOCUS ON
FAIRNESS AND HEALTH DISPARITIES.
LASTLY FROM THE UNIVERSITY OF
PUERTO RICO CANCER CENTERS, THEY
DEVELOPED TRAINING THAT FOCUSED
ON TECHNIQUES AND METHODS
SPECIFIC TO CANCER DATASETS IN
HISPANIC POPULATIONS.
BOTH MAKING THEM FAIR AND A.I.
READY, AND DEVELOPING PLODEL TO
ANALYZE
ANNUAL -- DEVELOPING A MODEL.
THERE SEEMED TO BE A HUNGER
AMONGST TRAINING CENTERS FOR
THIS TYPE OF TRAINING AND
DEVELOPING IT.
BRIDGING THAT GAP BETWEEN DATA
SCIENCE AND BIOMEDICAL TRAINING.
AND WE FELT IT WAS A KEYSTONE
OPPORTUNITY THAT LED US TO
TODAY.
NEXT SLIDE.
INITIALLY ODD SUPPORTED A
GENERATION OF SUPPORTING
PRACTICES AND RESOURCES AIDING
OTHERS IN MAKING ETHICAL
DECISIONS THROUGHOUT DEVELOPMENT
AND USE OF A.I. AND M.L.
THE MOST COMMON FOCUS AREAS WITH
COMMUNITY ENGAGEMENT, TRUST AND
EQUITY.
FIRST HIGHLIGHT ON THE TOP FROM
ICAHN SCHOOL OF MEDICINE AT
MOUNT SINAI EXAMINING
PERSPECTIVES AND OTHER
STAKEHOLDERS, ON A.I.-DRIVEN
AUTOMATED SCREENING IN SPECIFIC
SPACE OF COGNITIVE IMPAIRMENT,
EXPLAINED METHODS TO IMPROVE
TRUST AND DETECT BIASES IN
MODELS FOR ALZHEIMER'S DISEASE
AND RELATED DEPARTMENT.
SECONDA FRAMEWORK TO QUANTIFY
AND INCORPORATE UNCERTAINTY FOR
A.I.-BASED IMAGING AND USE OF
SYNTHETIC DATASETS.
POLICY AND ETHICAL
CONSIDERATIONS FOR SYNTHETIC
DATASETS IN PREDICTIVE MODELS
AND PUBLISHED AROUND THESE
AREAS.
THROUGH THIS PROGRAM WE LEARNED
THERE'S A KEEN INTEREST AMONGST
BIOMEDICAL P.I.s TO DELVE INTO
AND ENGAGE IN THE DEVELOPMENT OF
ETHICAL PRACTICES AND TOOLS.
IT'S BRIDGING DATA SCIENCE WITH
TRAINING AND ETHICS, AND THE
FEEDBACK LED US TO PROPOSED
SOLICITATIONS TODAY.
ODSS SUPPORTED BRINGING TOGETHER
EXPERTISE IN MEDICINE, TO MAKE
NIH DATA A.I. READY.
FIRST FROM OREGON HEALTH AND
SCIENCE UNIVERSITY, DEVELOPING
A.I. READY DATASETS FOR USE IN
AUTOMATED SPEECH RECOGNITION
MODELS.
THEY ALSO ENGAGED COMMUNITY IN
POST-STROKE SPEECH CHALLENGE TO
INVITE RESEARCHERS TO PROMOTE
AWARENESS OF DATASETS.
A SECOND COMES FROM UNC-CHAPEL
HILL, TO FILL IN MISSING BRAIN
IMAGES IN COHORT STUDY OF EARLY
BRAIN DEVELOPMENT, EXPANDING THE
POTENTIAL APPLICATIONS OF M.L.
APPROACHES TO LEVERAGE THE RICH
DATASET.
WE LEARNED THERE'S A NEED FOR
ENABLING TEAMS TO MAKE DATASETS
A.I. READY BUT ALSO ILLUSTRATING
MANY CHALLENGES ALONG THIS PATH
WHICH I'LL GO THROUGH ON THE
NEXT SLIDE.
THIS NEED TO EXPAND TRAINING IN
THIS AREA TO ENCOURAGE FROM
INITIAL RESEARCH AND DATA
PLANNING STAGES.
NEXT SLIDE PLEASE.
CONVENING RESEARCH TEAMS FROM
THESE COHORTS OF PROGRAMS WE
HELD TWO P.I. MEETINGS BRINGING
TOGETHER AWARDEES AND MANY
CHALLENGES WERE SHARED WITH US.
THESE CHALLENGES INCLUDED
BIOMEDICAL A.I. RESEARCH IS NOT
BRINGING TOGETHER NEEDED
MULTI-DISCIPLINARY TEAMS WITH
SPECIFIC CHALLENGES FOR THIS
ETHICAL RESPONSIBLE A.I.
PRACTICE.
BIOMEDICAL RESEARCHERS ARE ALSO
OFTEN NOT SUFFICIENTLY TRAINED
IN THE A.I. SPACE.
PARTICULARLY WITH REGARD TO FAIR
PRINCIPLES, NOT BEING
INCORPORATED INTO TRADITIONAL
COURSES BEING OFFERED.
AND FINALLY WE HEAR A DEARTH OF
BIOETHICISTS AND HUMANITIES
PROFESSIONALS CRITICAL PARTNERS
AND COLLABORATORS, ENGAGED IN
THE BIOMEDICAL-A.I. SPACE
SHOWING A NEED FOR TRAINING IN
BIOMEDICAL WITH CASES TO ENABLE
MOVEMENT INTO PRACTICE.
THE TEAM-BASED SCIENCE NEEDS TO
BE HIGHLIGHTED, INTERSECTION OF
ETHICS AND BIOMEDICAL A.I.,
ENHANCING PATHWAYS AND NEED OF
FAIR DATA, BEGINNING THE EARLY
RESEARCH PLANNING PHASE.
ENGAGEMENT AND PARTICIPATORY
PRACTICES NEED TO BE
INCORPORATED INTO THESE
TRAININGS THAT ARE OFFERED.
ALL THESE TAKEN TOGETHER BROUGHT
US TO PROPOSED INITIATIVES WE'RE
DESCRIBING TODAY.
I'M GOING TO HAND IT OVER TO
SUSAN TO CLOSE US OUT.
>> CLOSING WHERE WE STARTED, THE
EXECUTIVE ORDER ON SAFE, SECURE,
TRUSTWORTHY A.I., WE NEED TO
PREPARE THE NEXT GENERATION OF
RESEARCHERS AND TEAMS FOR
ETHICAL A.I. TO ENSURE WE MAKE
GOOD ON OUR PROMISE OF A.I. IN
BIOMEDICAL RESEARCH AND
RESPONSIBILITIES THAT COME WITH
A.I., ITS DEVELOPMENT AND USE
ARE TAKEN CARE OF.
THIS IS A REALLY CRITICAL AND
IMPORTANT COMPONENT.
ONE MORE CLICK TO GET TO THE
NEXT STEPS.
THERE'S THE EXECUTIVE ORDER.
OUR WORK, BIOMEDICAL RESEARCH
WORK, IS A KEY COMPONENT OF THE
U.S. GOVERNMENT'S PRIORITIES ON
ARTIFICIAL INTELLIGENCE,
PROMINENTLY MENTIONED THROUGHOUT
THE EXECUTIVE ORDER.
AND MANY OF THE OTHER DOCUMENTS
YOU SEE LISTED HERE.
WE HAVE A RESPONSIBILITY TO
TRAIN BIOMEDICAL RESEARCHERS IN
THE A.I. SPACE.
WE'RE IN THE GENERATION OF A.I.
WE CAN'T REALLY JUST RELY ON
NSF.
THE WORK HAS SPECIFIC COMPONENTS
TO HELP DATA AND TO BIOMEDICAL
RESEARCH.
WE NEED TO BE CO-INVENTORS ON
A.I., NOT JUST CONSUMERS OF A.I.
I BELIEVE I FURNISH TO FRANCESCA
TO WORK ON THE CONCEPT ACTIONS.
>> ALL RIGHT.
THANKS, SUSAN.
WE'RE GOING TO HAVE A BIT OF
DISCUSSION BEFORE WE GO INTO THE
VOTE.
SO KEVIN, YOU'RE UP FIRST, IF
YOU HAVE COMMENTS OR QUESTIONS
OR THOUGHTS TO SHARE ABOUT THIS
CONCEPT.
>> THANK YOU.
WONDERFUL JOB, EVERYBODY.
I'M EXCITED BOTH ABOUT THESE
PROPOSALS BUT ALSO ABOUT THE
RESPONSE TO OUR INITIAL REVIEW
OF THESE CONCEPTS, HOW
RESPONSIVE YOU'VE BEEN.
CONGRATULATIONS.
HIGH LEVEL OF ENTHUSIASM FOR
INTENT AND STRUCTURE, EMPHASIS
ON TRAINING, ESPECIALLY
UNDERGRADS, THE WORK FORCE FOR
THE COUNTRY IS POPULATED WITH
TALENTED UNDERGRADUATE STUDENTS
SO DEVELOPING EDUCATIONAL
MATERIALS TO UNDERSTAND THEIR
NEEDS AND NEEDS OF DATA IS GOING
TO BE ESPECIALLY IMPORTANT FOR
THAT WORKFORCE.
THE INTENT OF THE PRE-DOCTORAL
WORK TO SUPPORT WELL AND LESSER
RESOURCED INSTITUTIONS, WHICH IS
A POSITIVE.
I RECOGNIZE WE DON'T NECESSARILY
HAVE A PLAN YET.
YOU'VE DONE IT SO WELL WITH MANY
OTHER INITIATIVES ON THE FIRST
SLIDE.
CONFIDENT YOU NOW HAVE INROADS
INTO THOSE PLACES.
LET'S SEE.
INFORMATION OBTAINED FROM THE
RESEARCH COMMUNITIES WAS A
THOUGHTFUL WAY TO ADDRESS WHAT
IS NECESSARY AND SHOULD HELP
WITH CURRICULUM DEVELOPMENT
AWARDS.
FUTURE PHASES WILL INCLUDE
MEETINGS AND GATHERINGS OF
MENTORS AND NIH PROGRAMS TO
CREATE COMMUNITY AT THE
INTERSECTION OF THESE TRICKY
ISSUES FOR POSTDOCTORAL
PROGRAMS.
THE FUTURE SPACES INCLUDE
ENHANCEMENTS, LESS CONCERNED
ABOUT SUSTAINABILITY AND
PARTNERSHIPS IF THIS GROUP OF
R25 AWARDEES ARE REQUIRED TO
WORK TOGETHER IN SOME CAPACITY
FROM THE BEGINNING.
MY FIRST COME WOULD BE IS THERE
A WAY TO GET THEM TO WORK
TOGETHER FROM THE BEGINNING AND
FURTHERMORE IS THERE A WAY WE
COULD GET THE POSTDOCS TOGETHER
SOONER THAN FUTURE PHASE BECAUSE
GIVEN HOW NEW THIS IS, THAT KIND
OF GROUP INFORMATION IS GOING TO
BE REAL HELPFUL.
THE R25 AWARDEES MY GUESS WILL
BE DEVELOPING COURSES INCLUDING
TOOLS AND INFRASTRUCTURE.
MY EXPERIENCE HERE IS THAT IF
THOSE TOOLS AND INFRASTRUCTURE
GET USED IN COURSES THAT ARE
NUMBERED IN THE SCHOOL, THEY
WILL ACTUALLY BE PROVIDED WITH
WAYS TO SUSTAIN THEM AS PART OF
THE COURSE.
I DON'T KNOW IT'S AS BIG A
CONCERN.
IF YOU SHIFTED FUNDING TO
SUPPORT THE GROUP EFFORTS MORE
THAN SUPPORT SUSTAINABILITY, I
WOULD BE EVEN MORE ENTHUSIASTIC.
WHICH IS HARD TO BEAT.
I HAVE A QUESTION ABOUT THE K01
AWARDEES, WHETHER THEY WILL BE
REQUIRED TO CREATE AND FOLLOW A
TEACHING PLAN.
PERHAPS GIVEN THAT IT'S A K
MECHANISM, THAT'S ASSUMED, BUT
IN THE DOCUMENTS THAT I HAVE
THERE WAS NO STATEMENT MADE
ABOUT WHAT THEY ARE GOING TO DO
IN TERMS OF THEIR OWN
DEVELOPMENT IN THIS AREA.
AND GIVEN THE FACT THESE ARE IN
PARALLEL IT MIGHT BE USEFUL TO
MAKE SURE THE K AWARDEES ARE
COMING FROM INSTITUTIONS THAT
YOU THINK COULD HAVE, FOR
EXAMPLE, BEEN AWARDED AN R25
BECAUSE THE CURRICULUM.
AS ALSO I WROTE AS NOTED IN THE
FINDINGS FROM RESEARCH
COMMUNITIES YOU LISTED, IT'S
UNLIKELY DOCTORAL STUDENTS IN
BIOMEDICAL RESEARCH WILL HAVE
LEARNED ABOUT ETHICAL AND FAIR
A.I. SO GIVING THEM A K AWORD
WOULD BE SIMILAR TO EDUCATIONAL
COMPONENT SIMILAR TO INFORMATICS
WHERE WE PHYSICIANS WHO GET
ADVANCED TRAINING OR FELLOWSHIPS
GO THROUGH A MASTER'S DEGREE
BECAUSE WE ASSUME THEY DON'T
HAVE THE ADDITIONAL EXPERIENCE.
MY LAST QUESTION WOULD BE WOULD
ONE INSTITUTIONING ELIGIBLE FOR
R25 AND K01 AWARDS, IT WOULD
SEEM THAT COULD HAPPEN AND I
DIDN'T KNOW WHETHER WE WERE
EMBRACING THAT OR GIVEN THE FACT
THE FUNDING IS PHASED IN WOULD
PREFER THAT NOT BE THE CASE.
THAT'S ALL I HAVE.
>> WOULD YOU LIKE ME TO TAKE
THOSE?
>> I CAN START AND PASS TO YOU.
I'M RESONATING WITH YOUR
COMMENTS.
I APPRECIATE YOUR INSIGHT INTO
SUSTAINABILITY.
I THINK WE'LL TAKE THAT UNDER
CONSIDERATION AS WE THINK ABOUT
HOW WE'LL SHIFT THE FUNDING AND
GET THE FOLKS FUNDED, POSTDOCS
AND GRADUATE STUDENTS TOGETHER
EARLY ON TO THINK ABOUT
COLLABORATIVE PROJECTS.
SUCH A GREAT IDEA.
YOU MADE A GOOD POINT ABOUT THE
K01, I'LL PASS TO LAURA FOR HER
COMMENTS, SHE MIGHT PASS TO
CHRISTINE TOO.
>> I WANT TO ADD MY THANKS.
THANK YOU FOR YOUR COMMENTS, FOR
THIS CONCEPT AND ALSO FOR THE
PREVIOUS ONE.
COMMENTS WERE HELPFUL IN SHAPING
HOW WE CAME TO TODAY.
I ALSO LIKE YOUR IDEA OF
BRINGING THE COHORTS TOGETHER
SOONER RATHER THAN LATER.
WE ENDEAVORED TO DO THAT WITH
SUPPLEMENTAL AWARDEES, THEY
APPRECIATED HAVING A KICKOFF
MEETING SOON.
THEY GOT TO GET EXPOSED TO THE
DIFFERENT ACTIVITIES ACROSS NIH
AND ARTIFICIAL INTELLIGENCE AND
ALSO TO EACH OTHER, THAT SEEMED
TO BE ENJOYED.
I WOULD LOVE TO DO MORE OF THAT.
ABOUT THE EDUCATION COMPONENT,
WE HADN'T MADE A DECISION, WERE
THINKING ABOUT LEAVING THAT AS A
PROPOSAL-DRIVEN THING, WOULD
LOVE YOUR ADVICE WHETHER WE
SHOULD BE MORE PRESCRIPTIVE ON
THAT FRONT.
>> MY ADVICE, YOU SHOULD BE MORE
PRESCRIPTIVE.
>> VERY GOOD.
YOU MENTIONED A COMMENT ABOUT
TEN INSTITUTIONS, R25 AND K01.
THERE'S NOTHING THAT WOULD
PRECLUDE THAT.
WE PRAY PRIORITIZE
UNDERREPRESENTED INSTITUTIONS,
MULTIPLE AWARDS, I WOULDN'T
PRECLUDE THAT AT ALL.
>> OKAY.
THANK YOU.
>> GREAT.
I'LL JUST MENTION, KEVIN, A
COMMENT MADE ME THINK ABOUT OUR
ERA EFFORT, THAT'S ANOTHER
PATHWAY IN WHICH WE CAN CONTINUE
TO ENGAGE A VARIETY OF EFFORTS,
MIGHT BE SOMETHING WE WANT TO
FLAG TO BRING TO AWARENESS OF
THE COUNCIL AT A NEXT MEETING.
>> YEAH.
>> LET'S SEE.
UNLESS THERE'S ANYTHING ELSE,
KEVIN, I'LL TURN IT OVER TO
RAFAEL.
ANYTHING ELSE YOU WISHED TO ADD
OR EMPHASIZE OR ASK ABOUT?
>> YES, I HAVE SOME CONCERNS AND
SUGGESTIONS.
SO THE GENERAL CONCERN REGARDS
CONFUSION AROUND TERMS LIKE A.I.
AND M.L. CURRENTLY, HOW THEY ARE
PRONE TO BEING USED AS MARKETING
TOOLS INSTEAD OF DESCRIBING
SCIENTIFIC GOALS.
SO BECAUSE OF THIS CONFUSION I
HAVE SOME CONCERNS ABOUT A
LITTLE BIT OF VAGUENESS I SEE IN
THE PROPOSAL.
I'M GOING TO GIVE YOU SOME
SUGGESTIONS, EXAMPLES THAT
HOPEFULLY CAN HELP.
SO FIRST, I WAS CURIOUS HOW NIH
DEFINES ARTIFICIAL INTELLIGENCE,
AND THE THING I FOUND BY GOOGLE,
FUTURE WHEN MACHINES LEARN TO
PERFORM TASKS RATHER THAN
CARRYING OUT COMPUTATIONS.
THAT'S VERY BROAD.
LIKE A CHESS PLAYER WOULD BE AN
A.I. TOOL.
SO YOU SEE THAT IT'S BEING USED
ALSO IN A BROAD WAY AMONG
NIH-FUNDED RESEARCH.
I'VE SEEN EXAMPLES WHERE THE
TITLE OF A PAPER INCLUDES THE
TERM A.I. BUT WHEN YOU LOOK AT
THE METHODS THERE'S LOGISTIC
REGRESSION TO A TRAINING SET,
PREDICTING OUTCOME USING THE
MODEL WHICH I GUESS THIS FALLS
UNDER DEFINITIONS EVENTUALLY
MACHINES DOING IT BUT IT DOESN'T
SEEM LIKE WE NEED A TERM LIKE
A.I. TO DESCRIBE SOMETHING THAT
SIMPLE THAT'S BEEN AROUND FOR
OVER 100 YEARS.
MAYBE A LITTLE BIT LESS.
BUT THERE'S OTHER EXAMPLES WHERE
IT SEEMS MORE APPROPRIATE LIKE
SURGICAL ROBOTS TRAINED A DATA,
THAT SEEMS LIKE A GOOD EXAMPLE
OF WHAT I THINK OF AS A.I.
ANOTHER EXAMPLE WOULD BE HOW
DOCTORS NOW, MAYBE THEY ARE NOT
NECESSARILY SAYING IT IN PUBLIC
BUT USING ChatGPT TO WRITE
MEDICAL NOTES OR EVEN GET
DIAGNOSIS.
THE FUNDED PROJECT I SAW, SEEM
TO BE FOCUSED ON WHAT I WOULD
DEFINE AS MACHINE LEARNING,
WHERE YOU HAVE THE GENERAL IDEA
THAT YOU HAVE A TRAINING SET
THAT THAT INCLUDES OUTCOMES, YOU
MAKE PREDICTIONS WITH THE FITTED
MODEL IN THE FUTURE.
YOU CAN GET A ROBOT TO DO THAT
BUT IT'S NOT NECESSARILY THE
CASE.
EXAMPLES OF THAT CURRENTLY
WORKED ON, POLYGENIC RISK
SCORES, DETECTION FROM IMAGING,
CANCER DETECTION FROM BLOOD.
DEFINING SCORES TO ASSESS
LIKELIHOOD OF HEART ATTACK.
THOSE OF MAYBE WHAT YOU'RE
THINKING OF WHEN YOU SAY A.I.,
THESE ARE FOUR EXAMPLES, VERY
DIFFERENT.
THEY HAVE VERY DIFFERENT
CHALLENGES, METHODS ARE USED.
IT'S HARD FOR ME TO THINK HOW
YOU HAVE A DEFINITION OF A.I.
READY DATA FOR EXAMPLE WHEN
CONTEXTS ARE SO DIFFERENT.
SIMILARLY ETHICAL CONCERNS ARE
GOING TO BE DIFFERENT IN EACH.
ARE THERE GENERAL PRINCIPLES WE
COULD TALK ABOUT THAT WE COULD
BE FUNDING EVEN CURRICULA THAT
ARE CURRICULA THAT WOULD COVER
ALL THESE THINGS?
THAT'S MY CONCERN, TOO VAGUE AND
BROAD.
A.I. READY INVESTIGATORS, ONE OF
THE MOST CURRENTLY POPULAR
TECHNIQUES THAT ARE GETTING A
LOT OF ATTENTION, DEEP NEURAL
NETWORK, TRANSFORMERS, LARGE
LANGUAGE MODELS ARE COMPLICATED
MATHEMATICAL IDEAS.
I'M LEARNING ABOUT THEM, TOOK
QUITE A BIT OF TIME TO GO
THROUGH THE MATH.
RESEARCH TOPICS AND Ph.D.,
UNDERGRADUATES OR OTHER FIELD,
BIOLOGY OR MEDICINE, TO BE
LEARNING THESE THINGS, A CONCERN
HERE WOULD BE YOU'RE TRAINING
THEM ENOUGH TO USE THE TOOLS
WITHOUT REALLY UNDERSTANDING,
THAT ALWAYS CONCERNS ME.
I SEE IT WITH THINGS LIKE
STATISTICS, PEOPLE APPLYING
STATISTICAL METHODOLOGY,
UNDERSTANDING IT, A LOT OF
MISTAKES ARE MADE.
SIMILARLY TRAINING AND ETHICS
AGAIN BECAUSE IT SEEMS LIKE EACH
EXAMPLE WOULD BE DIFFERENT, NOT
CLEAR HOW YOU COULD HAVE A
GENERAL PROGRAM IN IT, FOR ME AT
LEAST.
I I DON'T KNOW WHAT AN EXPERT
WOULD BE, IT'S SUCH A NEW FIELD.
WHO IS GOING TO BE TEACHING
THIS?
IT'S SO NEW AND WE'RE STILL
FIGURING IT ALL OUT.
SO MY -- AGAIN MY SPECIFIC
SUGGESTION IS THAT YOU FOCUS THE
PROPOSAL AND IDENTIFY SPECIFIC
CHALLENGES, ETHICAL CHALLENGES,
BECAUSE THERE ARE MANY.
I'M NOT GOING TO LIST EXAMPLES,
THINGS THAT ARE QUITE
CONCERNING, WHAT'S HAPPENING
NOW, IDENTIFY SPECIFIC ETHICAL
CHALLENGE AND HAVE A FUNDING
PROGRAM TO TRY TO SOLVE THE
SPECIFIC PROGRAMS, RATHER THAN
HAVING IT LIKE THE GENERAL
DESCRIPTION OF A.I.-READY
INVESTIGATORS, A.I. READY DATA.
THOSE ARE MY COMMENTS.
>> THANK YOU, DR. IRIZARRY,
THOSE ARE IMPORTANT COMMENTS
WE'LL TAKE TO HEART.
ARTIFICIAL INTELLIGENCE IS A
VERY LARGE AND BROAD FIELD
COVERING TRADITIONAL MACHINE
LEARNING, NEURAL NET, DEEP
LEARNING, NOW GENERATIVE A.I.
AND ALL OF THE APPLICATIONS
THERE.
SO WE CAN ABSOLUTELY CALL IT
VERY SPECIFIC NEEDS.
WE'RE LOOKING AND INTERESTED IN
WHAT THE INSTITUTIONS WILL
PROPOSE, AND I WOULD IMAGINE
THAT ONE APPLICATION WOULDN'T
COVER THE WATERSHED OF ALL THAT
IS NEEDED AND TRAINING AND
ETHICAL DEVELOPMENT.
BUT WOULD IDENTIFY CERTAIN AREAS
THEY WOULD LIKE TO FOCUS ON.
SO THAT'S VERY GOOD ADVICE.
YOU'RE RIGHT, THIS IS A NEW
FIELD, ETHICAL A.I.
I THINK BUILDING THE FOUNDATION
IN UNIVERSITIES IN AREAS OF
BIOMEDICAL RESEARCH, RESEARCH IS
INCREDIBLY IMPORTANT, THIS WILL
HOPEFULLY START AND SEED THAT
WORK TO A MUCH LARGER PROGRAM.
SO WE'LL DEFINITELY TAKE YOUR
CONSIDERATION, WE'RE DEVELOPING
THE ACTUAL FUNDING ANNOUNCEMENT
TO TARGET A PAGE AND A HALF TO
BE SPECIFIC, IN THE FUNDING
ANNOUNCEMENT CAN BE MUCH MORE
SPECIFIC ABOUT THE TYPES OF
AREAS WE'RE INTERESTED N MOST
INSTITUTES ARE PARTNERING WITH
US TO ADD THEIR INPUT AND THEIR
VALUE AND MISSIONS INTO FUNDING
ANNOUNCEMENTS.
I'LL PASS TO LAURA.
>> GREAT RESPONSE.
THIS IS A FAST-MOVING FIELD,
VERY MUCH NASCENT ON THE
EDUCATION COMPONENT AT LEAST.
AND SO WE'RE -- YET THERE'S A
HUGE NEED, A HUGE NEED FOR
RESEARCHERS TO UNDERSTAND AT
LEAST WHAT IT MEANS FOR THEIR
DATA TO BE USED DOWNSTREAM IN
ARTIFICIAL INTELLIGENCE
APPLICATIONS AND ALSO GOOD
COLLABORATORS AND TO HAVE ENOUGH
UNDERSTANDING OF A.I. SO THEY
CAN UNDERSTAND HOW TO
CO-INNOVATE AS SUSAN MENTIONED.
SO WE'RE TRYING TO MEET -- WALK
THAT BALANCE AND APPRECIATE YOUR
COMMENTS.
>> ONE ADDITION TO THAT AS WELL.
WE'RE NOT THINKING PEOPLE
TRAINED US IN THESE KRUK -- CUA
WOULD DO EVERYTHING ON THEIR
OWN.
YOU CAN TELL MULTI-DISCIPLINARY
TEAMS HAVE BEEN VIEWED
THROUGHOUT AND WE ANTICIPATE
THEY WILL BECOME PART OF THIS
MULTI-DISCIPLINARY TEAM LIKE
LAURA WAS MENTIONING.
>> WHY DON'T WE NOW TAKE A
MOMENT, BECAUSE WE'RE A COUPLE
MINUTES OVER ALREADY BUT LET'S
OPEN UP FOR OTHERS ON THE
COUNCIL TO ASK QUESTIONS.
I SEE MICHAEL, YOU HAVE -- YOU
WOULD LIKE TO ASK A QUESTION.
I'LL TURN IT OVER TO YOU FIRST.
>> THANKS.
HELPFUL SUGGESTION, PERHAPS,
LOOKING AT THE WAY THE SCHMIDT
A.I. POSTDOCTORAL PROGRAM WAS
ROLLED OUT, I DON'T KNOW IF
YOU'RE FAMILIAR BUT DID IT MAKE
AN EFFORT TO RESPOND TO SOME OF
RAFAEL'S CONCERNS BY PARTNERING
BETWEEN PEOPLE, YOU KNOW, THAT
WERE IN THE A.I. DOMAIN AND
THOSE INDIVIDUALS IN
APPLICATIONS, SPECIFIC
APPLICATION DOMAINS.
WE BROUGHT TOGETHER, SYNERGY'S,
POSTDOCS, IN THE MIDDLE WHERE
THEY WOULD GET THE UNDERSTANDING
IN THE APPLICATION DOMAIN AND
PROBLEM IN TECHNICAL DOMAIN, IN
THIS CASE, IT MIGHT BE
WORTHWHILE TAKING A LOOK AT THAT
PROGRAM.
>> I HAVE SPOKEN TO SCHMIDT
ABOUT THE PROGRAM, A NUMBER OF
PROGRAMS HAVE -- THAT'S
ABSOLUTELY A VERY GOOD POINT AND
WE WILL NOT ONLY TALK WITH THEM
AND LOOK AT FURTHER PARTNERSHIP.
>> I JUST TURNED MY MIC OFF
INSTEAD OF ON.
MONICA, YOU HAVE A QUESTION AS
WELL.
>> THIS IS ACTUALLY A GREAT WAY
TO EXPLORE IT, TRAINING
OPPORTUNITIES, K01s, R25s.
MY QUESTION IS ON THE OTHER END,
WHAT ARE YOUR ETHICAL POLICIES
AT THE NIH ABOUT A.I.?
I SEE YOU NEED TO REVEAL OR NOT
USE A.I. IN GRANT WRITING,
THAT'S TRUE OF MANY PAPERS, YOU
HAVE TO AT LEAST REVEAL IF
YOU'VE USED IT.
BUT IS THERE A STANDARDIZED --
THE OTHER DISCUSSIONS HOW TO
DETECT IT, HOW TO -- PEOPLE
ARE -- I'M SURE A.I. AND HOW DO
YOU ETHICALLY INCORPORATE THAT
RIGHT NOW, INTO YOUR GRANT
WRITING PROCESS, AND REVIEW
PROCESS.
>> I DO KNOW WHAT WE'RE DOING
BUT I'LL SEE --
>> YOU CAN GO, SUSAN.
I'LL FILL IN ADDITIONAL DETAILS.
>> WE DO HAVE A POLICY, ISSUED
BY OFFICE OF EXTERNAL RESEARCH,
THAT REVIEWERS OF NIH GRANTS
CANNOT USE ONLINE ChatGPT OR
BARD, ET CETERA, GENERATIVE A.I.
IN THEIR WORK REVIEWING GRANTS.
IT DOES VIOLATE CONFIDENTIALITY
AGREEMENT.
SECOND WE WANT REVIEWERS TO GIVE
US INTELLECTUAL INPUT INTO THE
GRANT.
THERE'S A THOUGHT THAT IF WE
WANTED ChatGPT TO REVIEW
GRANTS WE COULD DO THAT
OURSELVES.
THAT'S A FORMAL POLICY, AS I
UNDERSTAND WE DO NOT HAVE
NECESSARILY A POLICY ABOUT
RESEARCHERS USING GENERATIVE
A.I. TO WRITE GRANTS.
THERE'S A LOT OF HALLUCINATIONS,
WITH ChatGPT AND OTHERS, FOR
WRITING GRANTS.
WE DON'T NECESSARILY RECOMMEND
IT BUT THERE'S NO POLICY AGAINST
IT.
WE ARE LOOKING AT WAYS IN WHICH
WE CAN DETECT MATERIALS
GENERATED FROM GENERATIVE A.I.
BUT IT'S VERY HARD IN SOME CASES
TO DO THAT.
IT'S AS RAFAEL SAID, AN
INCREDIBLY FAST-MOVING FIELD
WITHIN A FEW MONTHS, OPEN A.I.
ALGORITHM WILL COME OUT,
MASSIVE, IT WILL GROW WHERE WE
ARE WITH ChatGPT OUT OF THE
WATER.
SUCH A FAST-MOVING FIELD THAT
DETECTION AND WATERMARKS, --
WATERMARKINGS, IT'S GOING TO BE
HARD.
>> WE HAVE PILOTS ONGOING AS
SUSAN MENTIONED, LEVERAGING
RESOURCES TO IDENTIFY THOSE
APPLICATIONS THAT LEVERAGE THIS
TECHNOLOGY.
BUT IT'S REALLY NASCENT IN WHAT
WE'RE DOING, EVOLVING.
MORE TO COME.
SUSAN COVERED THAT NICELY.
IN THE INTEREST OF TIME I WANT
TO MAKE SURE THAT WE HAVE ENOUGH
TIME -- SUFFICIENT TIME TO COVER
THE LAST TWO TOPICS.
WHY DON'T WE -- I'M NOT SEEING
ANY OTHER ACTIVE QUESTIONS HERE.
WHY DON'T WE SHIFT TO THE VOTE
FOR THE CONCEPT.
>> THANK YOU.
WHAT I HEARD IS A LOT OF
ENTHUSIASM WITH SOME
RECOMMENDATIONS AND CONSTRUCTIVE
RECOMMENDATIONS.
I'M GOING WITH THE MOTION OR
CONCEPT AS IT WAS PRESENTED
ORIGINALLY AND SEE HOW THAT
GOES.
SO, I'M GOING TO CALL FOR A
VOTE.
MAY I HAVE A MOTION FOR APPROVAL
OF THE ODSS CONCEPT CLEARANCE
ENTITLED PREPARING THE NEXT
GENERATION OF BIOMEDICAL
RESEARCH TEAMS FOR ETHICAL A.I.
WORKFORCE AND CURRICULUM
DEVELOPMENT.
IS THERE SUCH A VOTE?
I SEE A MOVE.
I NEED ASK FOR A SECOND.
I SEE A SECOND.
THANK YOU VERY MUCH.
I'M GOING TO ASK IS THERE ANY
ADDITIONAL DISCUSSION ON THE
CONCEPT?
I DO NOT SEE ANYTHING.
SO THAT WILL MAKE ME MOVE IT
OVER TO CHRISTINA.
>> THANK YOU, DR. GRIEDER.
AS BEFORE, THE POLL SHOULD
APPEAR ON YOUR SCREEN WHEN IT IS
LAUNCHED.
PLEASE REMEMBER ONLY COUNCIL
MEMBERS SHOULD PARTICIPATE IN
THE POLL.
THE POLL WILL BE UP FOR 30
SECONDS.
IT'S STARTING NOW.
>> I THINK THE CAT VOTE IS NOT
GOING TO COUNT FOR THIS.
>> THAT'S A NO I THINK.
>> 15 SECONDS FOR THE VOTE.
>> YOU HAVE 15 SECONDS
REMAINING.
PLEASE REMEMBER TO HIT SUBMIT
FOR YOUR VOTE TO COUNT.
THE POLL IS NOW CLOSING.
WE'LL NOW SHARE THE RESULTS WITH
THE MEETING.
MOTION AS STATED HAS PASSED.
>> THANK YOU, CHRISTINA AND
COUNCIL MEMBERS AND PRESENTERS.
I'LL HAND IT BACK TO TARA.
>> ALL RIGHT.
THANK YOU SO MUCH.
COMMENTS ABOUT THE CAT VOTING
WERE GREAT.
VERY VOCAL CAT, SUSAN.
VERY OPINIONATED I GUESS ON A.I.
THANK YOU SO MUCH, SUSAN, LAURA,
AND CHRISTINE FOR THAT
PRESENTATION.
I KNOW WE'RE BEHIND SCHEDULE A
LITTLE BIT.
LET ME QUICKLY INTRODUCE AND
TURN IT OVER TO DR. STEFAN
PASIAKOS, DIRECTOR OF DIETARY
SUPPLEMENTS IN DPCPSI, TALKING
ABOUT A IN STRATEGIC PLAN FOR FY
25-29.
I'LL TURN IT OVER TO YOU,
STEFAN.
>> THANK YOU, TARA.
GOOD AFTERNOON.
I WANT TO RECOGNIZE COUNCIL
MEMBERS AND THOSE IN ATTENDANCE.
I AM AS SHE SAID RELATIVELY NO
DIRECTOR OF OFFICE OF DIETARY
SUPPLEMENTS, JUST ABOUT A YEAR
INTO MY APPOINTMENT.
EXCITING OPPORTUNITY,
CULMINATION OF THE LAST EIGHT OR
NINE MONTHS OF WORK IN THE
OFFICE, AN OPPORTUNITY TO SHARE
PRINCIPLES AND FOUNDATIONS TO
GUIDE ODSS THROUGH 2029, A
BLUEPRINT TO BUILD A COORDINATED
PROGRAM HERE AT NIH.
I'M PASSIONATE ABOUT THIS FIELD,
STEMMING FROM MY TRAINING, 15
YEARS OF LEADING A LAB IN
DIETARY SCIENCE.
SUPPLEMENTS ARE PART OF THE
AMERICAN LANDSCAPE, $60
$60 BILLION
A YEAR INDUSTRY, MORE THAN HALF
REPORT USING SUPPLEMENTS.
IN SOME SEGMENTS CAN INCREASE
BEYOND 70%.
HEALTH BENEFITS CAN SOMETIMES BE
BASED ON MISINFORMATION OR
INCONCLUSIVE SCIENCE, IN SOME
CASES WHEN TAKEN IN EXCESS CAN
CAUSE HARM.
GIVEN THIS DATA SCIENCE
CONSTANTLY EVOLVING OUR JOB IS
TO BE HONEST BROKERS FOR SCIENCE
OF DIETARY SUPPLEMENTS SO THE
AMERICAN PUBLIC HAS THE
INFORMATION THEY NEED.
WHAT YOU'LL HEAR OVER THE NEXT
20 MINUTES IS A BOLD VISION FOR
ODS, BUILT UPON STAFF, PASSION,
TALENT, DEDICATION AND
ACCOMPLISHMENTS OVER THE LAST
SEVERAL DECADES, OBJECTIVE OF
FACILITATING INNOVATION AND NEW
SCIENCE BY PRIORITIZING
COORDINATION AND COLLABORATION
HERE AT NIH.
NEXT SLIDE.
DEVELOPMENT OF STRATEGIC PLAN
DOES NOT HAPPEN IN A VACUUM.
THERE ARE COORDINATED STEPS.
LET ME TAKE YOU THROUGH THE
PROCESS.
THE OFFICE OF DIETARY
SUPPLEMENTS HAS BEEN WITHOUT
ACTIVE STRATEGIC PLAN SINCE 2021
BECAUSE THE OFFICE WAS WITHOUT A
PERMANENT DIRECTOR FROM 2019 TO
LAST JULY.
AN UNPUBLISHED STRATEGIC PLAN
WAS VETTED.
DPCPSI LEADERSHIP SLIDED NOT TO
PUBLISH -- DECIDED TO HOLD OFF.
WHEN I WAS HIRED I REVIEWED THAT
DRAFT AND PRIORITY TO IMPLEMENT
NEW VISION TO CARRY US INTO THE
FUTURE, WHAT YOU'RE GOING TO
HEAR ABOUT TODAY.
THAT FEEDBACK COUPLED WITH
FEEDBACK FROM PARTNERS, AS WELL
AS REVIEW OF ONGOING EFFORTS.
WE CAME TOGETHER AS OFFICE TO
RESET AND ESTABLISH NEW VISION,
MISSION, VALUE SET.
THE PLAN WAS DRAFTED, SENT OUT
ACROSS NIH WITH OTHER FEDERAL
AGENCIES AND WITH LEADING TRADE
ORGANIZATIONS IN DIETARY
SUPPLEMENTS.
YOU'LL HEARING THOSE RESULTS
TODAY.
GOAL IS TO PUBLISH A PLAN
OPERATIONALIZED IN 2025.
I FELT IT WAS CRITICALLY
IMPORTANT TO GET TO KNOW THE
PEOPLE, THE OFFICE, WHAT THEY
DO, HOW THE OFFICE EVOLVED OVER
30 YEARS, AND REESTABLISH WHO WE
ARE, NOT TO FORCE CHANGE FOR THE
SAKE OF CHANGE BUT MY INTENT WAS
TO TAKE WHAT I HOLD TRUE AS
SCIENTIST AND LEADER AND WE'VE
INTO THE OFFICE -- WEAVE INTO
THE OFFICE.
WE'RE A COORDINATING OFFICE IN
DPCPSI OUR VISION IS TO BE
SCIENTIFIC AUTHORITY AND
CONVENING BODIES FOR ADVANCING
DIETARY SUPPLEMENTS.
OUR MISSION IS SIMPLE IF YOU
BOIL IT DOWN TO A FEW WORDS, TO
COORDINATE CUTTING-EDGE RESEARCH
PRIMARILY HERE AT NIH.
TO BE SUCCESSFUL WE MUST BE
GROUNDED IN VALUES.
WE'LL APPROACH EFFORTS WITH
RESPECT FOR NIH, THE FEDERAL
GOVERNMENT AND ITS PRIORITIES,
AND PUBLIC HEALTH.
CURIOSITY IS CRITICAL.
WE NEED INNOVATIVE THOUGHT, TO
BE CREATIVE, AND WE NEED TO
THINK BIG.
MOST IMPORTANTLY WHILE THINKING
BIG WE NEED TO BE PRAGMATIC WITH
HOW WE FUNCTION.
WE NEED TO BE ACCOUNTABLE TO DO
WHAT WE SAY WE'RE GOING TO DO.
DELIVER ON THE STRATEGIC PLAN.
FOR THOSE IN ATTENDANCE, AND
THOSE FAMILIAR WITH THE OFFICE
OF DIETARY SUPPLEMENTS, YOU'LL
NOTICE WHAT WE PUT FORWARD IS A
REIMAGINING OF THE OFFICE.
OUR BLUEPRINT IS CENTERED ON
THREE GOALS, BASIS OF OUR
PROGRAMS AND PRIORITIES.
RESEARCH IS NUMBER ONE.
WHAT I MEAN IS ODS WILL
PRIORITIZE ABOVE ALL ALSO
COORDINATION AND SUPPORT OF
RESEARCH HERE AT NIH BY
EMPHASIZING SCIENTIFIC
DISCIPLINES.
RESEARCH CAPACITY, SECOND GOAL,
HOW WE ENABLE PROGRESS, TO USE
ALL AVAILABLE TOOLS AT OUR
DISPOSAL IN THE DIVISION.
FUNDING ROBUST AND RELEVANT
RESEARCH PORTFOLIO.
OPERATIONS AND RESOURCES TO
IMPLEMENT A SERIES OF SYSTEMS
AND POLICIES THAT SUPPORT
PROFESSIONAL DEVELOPMENT IN MANY
WAYS, PRIORITIZING DIVERSITY,
EQUITY, AND INCLUSION, AND
ENSURES MANY AUDIENCES ARE
WELL-INFORMED ABOUT ROLE OF
DIETARY SUPPLEMENTS AND HEALTH.
NEXT SLIDE.
SO ON THIS SLIDE YOU SEE A
FIGURE THAT REPRESENTS THE
ORGANIZATIONAL STRUCTURE.
IT WAS APPARENT WHEN I CAME ON
BOARD I WAS AN OUTSIDER TO NIH,
TO DPCPSI, AND I DIDN'T KNOW
MUCH ABOUT THE OFFICE OF DIETARY
SUPPLEMENTS OTHER THAN WHAT I
FOUND ON THE WEBSITE AND KNEW IN
TERMS OF PEER-REVIEWED
PUBLICATIONS.
I CAME TO REALIZE ODS IS A SMALL
OFFICE WITH A MODERATE SIZE
BUDGET, WE HAVE TO DO IS A LOT
WITH VERY LITTLE IN TERMS OF
STAFFING AND MANPOWER.
CRITICALLY IMPORTANT TO ODS NOT
BE STRUCTURED THAT LEADS TO
SILOED ACTIVITIES OR STIFLE
CREATIVITY, OR DETRACT FROM OUR
ABILITY TO COLLABORATE.
WHAT I WANT YOU TO TAKE AWAY IS
ODS WILL ADOPT AND FUNCTION AS A
TRULY INTERCONNECTED PRO-ACTIVE
AND PRIORITY-BASED COORDINATING
OFFICE.
WE'RE GOING TO START AT THE
CENTER.
THE FIRST STEP IS CENTER OUR
EFFORTS ON SHARED SCIENTIFIC
PRIORITIES.
WE WENT THROUGH BROAD SCIENTIFIC
INTERESTS ACROSS NIH.
THE STRATEGIC PLAN, THOSE ARE
CROSS-CUTTING THEMES, DIVERSE
POPULATIONS, HEALTHY LIFESPAN,
RESILIENCE.
TO ADDRESS THOSE WE NEED
RESEARCH PROGRAMS AND FINANCIAL
EXPERTISE TO MAKE SCIENTIFIC
ADVANCES.
THESE ARE PROGRAMS WITH
BIOLOGICAL, ANALYTICAL,
POPULATION SCIENCES.
RESEARCH CAPACITY MUST BE
EMPHASIZED.
THAT'S THE NEXT LAYER IN THE
ORGANIZATIONAL STRUCTURE.
THAT INCLUDES METHODOLOGY AND
RESEARCH FUNDING STRATEGY
PROGRAMS.
AND FINALLY INFORMING WHAT WE
DO, WHAT PEOPLE SEE IN THE
OFFICE, OUR OPERATIONS AND
RESOURCES PROGRAMS.
THOSE INCLUDE SCIENCE AND HEALTH
COMMUNICATIONS PROGRAM, DIETARY
SUPPLEMENT DATABASES, MANAGEMENT
AND ADMINISTRATIVE SUPPORT.
SO ALL OF THE PROGRAMMATIC
LAYERS OUTLINED IN THIS FIGURE
ARE NEEDED TO COORDINATE
RELEVANT AND INNOVATIVE SCIENCE
TO MAKE BEST USE OF TAXPAYER
DOLLARS.
NEXT SLIDE.
THE NEXT THREE SLIDES PRESENT
CROSS-CUTTING THEMES AND
OBJECTIVES.
FIRST DIVERSE POPULATIONS.
FOCUS ON DIVERSE POPULATIONS
STRESSES IMPORTANCE OF
UNDERSTANDING UNIQUENESS OF THE
MANY POPULATION SUBGROUPS IN THE
UNITED STATES.
DIVERSE POPULATIONS INCLUDE
THOSE DESIGNATED BY NIH AS
POPULATIONS WITH HEALTH
DISPARITIES.
SUCH AS RACIAL AND ETHNIC
MINORITY GROUPS, LOWER
SOCIOECONOMIC STATUS,
UNDERSERVED RURAL COMMUNITIES,
SEXUAL AND GENDER BUY MINORITY
GROUPS, PEOPLE WITH
DISABILITIED.
WE INCLUDE PEOPLE OF DIFFERENT
AGE, SEX, GENDER, GEOGRAPHIC
LOCATION, HEALTH STATUS,
LANGUAGE AND CITIZENSHIP STATUS.
AS AN OFFICE AND FIELD WE NEED
TO DO A BETTER JOB UNDERSTANDING
HOW DIFFERENT POPULATION
CHARACTERISTICS AND
INTERSECTIONALITY IMPACT USE OF
NUTRIENTS AND PHYTOCHEMICALS IN
DIETARY SUPPLEMENTS AND TRIP TO
FOOD INTAKE AND HOW IT MAY
INFLUENCE HELP ACROSS THE
LIFESPAN.
OUR EFFORTS WILL ENSURE DIVERSE
POPULATIONS ARE EQUITABLY
REPRESENTED IN SCIENCE AND WE
SUPPORT AND HAVE ACCESS TO
PUBLIC HEALTH INFORMATION WE
DISSEMINATE.
NEXT SLIDE PLEASE.
SECOND THEME IS HEALTHY
LIFESPAN, SELF-EXPLANATORY.
I'LL GIVE CONTEXT.
THROUGHOUT LIFE PEOPLE
EXPERIENCE PHASES, PHYSICAL,
COGNITIVE, GROWTH, DEVELOPMENT,
MATURATION, UNFORTUNATELY
DECLINE.
EACH STAGE WHETHER PREGNANCY,
INFANCY, CHILDHOOD, ADOLESCENCE,
ADULTHOOD, OLD AGE, COINCIDES
WITH CHANGING NUTRITIONAL NEEDS.
THIS PROVIDES OPPORTUNITY TO
EXPLORE ASSOCIATIONS BETWEEN
SUPPLEMENT USE, DISEASE
PREVENTION AND HEALTH
OPTIMIZATION AT LIFE STAGES.
BIOLOGICAL MECHANISMS THROUGH
WHICH SUPPLEMENTS MAY IMPACT
HEALTH.
TOPICS OF INTEREST ARE MANY, IN
TICKLES MEDICATIONS.
AND LIFESTYLE FACTORS SUCH AS
SLEEP, PHYSICAL ACTIVITY,
UNDERLYING DIETARY INTAKE.
SOME DISEASES AND CONDITIONS
BEING CONSIDERED, MUCOSAL
IMMUNITY, DIGESTIVE HEALTH,
AUTOIMMUNE DISEASE AND
CARDIOVASCULAR DISEASE.
OBESITY, PHYSICAL ACTIVITY,
CARDIOMETABOLIC, SARCOPENIA AND
AGE-RELATED COGNITIVE DECLINE.
FINAL CROSS-CUTTING THEME IS
RESILIENCE, FOCUSED FRAMED BY
TRANS-NIH GROUP, WORKING GROUP
DEFINITION.
CAPACITY TO RESIST, ADAPT,
RECOVER OH GROW FROM A
CHALLENGE.
IT'S UNDERSTOOD RESILIENCY MAY
BE ATTRIBUTED TO PHENOTYPIC
SIGNATURES.
QUESTIONS IN THIS THEME COULD BE
ARE IS THERE DIFFERENCES IN HOW
DIETARY SUPPLEMENTS INFLUENCE
PATHWAYS AND DO THEY DIFFER BY
SUBGROUPS?
WHAT ARE CRITICAL LIFE STAGES
FOR OPTIMIZING RESILIENCE, AND
HOW DOES DOSING, TIMING AND
DURATION OF DIETARY SUPPLEMENT
USE AFFECT RESILIENCE PATHWAYS
IN DIFFERENT POPULATIONS ACROSS
THE LIFESPAN.
AS I CLOSE OUT THIS SECTION, I
WANT TO HIGHLIGHT OUR RECENT
WORK THAT WILL COME TOGETHER IN
COMING MONTHS, BECAUSE WHAT THIS
DESCRIBES IS LAYING FOUNDATION
FOR COORDINATIONING CONCEPT
INITIATIVES.
WITH THE FOCUS ON WOMEN'S HEALTH
HERE AT NIH, WE'RE WORKING
CLOSELY TO IDENTIFY KNOWLEDGE
GAPS, HOW DIETARY SUPPLEMENTS
IMPACT HEALTH PROMOTION ACROSS
THE LIFESPAN IN POPULATIONS OF
WOMEN, AS WOMEN AGE REQUIREMENTS
CHANGE.
THE OFFICE WILL CONSIDER
UNDERSTANDING USE AND IMPACT OF
DIETARY SUPPLEMENTS AT DIFFERENT
LIFE STAGES, INCLUDING PRE AND
POST NATAL FEW TRIGS, PERI AND
POSTMENOPAUSAL PERIODS.
WE'RE WORKING TO BUILD
PARTNERSHIPS TO IDENTIFY
RESEARCH GAPS AND REFINE HOW
SUCH WORK WILL EVENTUALLY
MANIFEST.
NEXT SLIDE PLEASE.
THESE SLIDES DETAIL RESEARCH
CAPACITY AND OPERATIONS AND
RESOURCES PROGRAM, OBJECTIVES,
PRIORITIES IN EACH PROGRAM.
OBJECTIVES TO COORDINATE
RESEARCH ANALYSES TO IDENTIFY
RESEARCH KNOWLEDGE GAPS,
COLLABORATE CLOSELY WITH NIH ICO
PROGRAM STAFF TO IDENTIFY
RESEARCH TOPICS OF INTEREST THAT
ADDRESS KNOWLEDGE GAPS ALIGNING
WITH ODS CROSS-CUTTING THEMES
AND ICO INTEREST AREAS.
AND FINALLY CURED NATE --
COORDINATE RESEARCH INITIATIVES,
FOR EACH THEME ACROSS BIOLOGICAL
POPULATION AND ANALYTICAL
SCIENCES PROGRAM.
NEXT SLIDE PLEASE.
FIRST PROGRAM IS BIOLOGICAL
SCIENCES, PRIORITY LAID OUT
THERE.
I WILL SAY ODS HAS FOCUSED
THROUGHOUT ITS HISTORY, AND WILL
CONTINUE TO DO SO AND LOOK TO
ADVANCE BIOLOGICAL STUDY OF
EFFECTS ON HEALTH, AND INTERNAL
AND EXTERNAL FACTORS THAT MAY
MODULATE THEIR EFFECTS.
TO SUPPORT THE THEMES WE'LL
FOCUS ON UNDERSTANDING
BIOLOGICAL MECHANISMS FOR WHICH
DIETARY SUPPLEMENTS AFFECT
PATHWAYS, UNDERSTANDING
INTERACTIONS WITH DIET,
SUPPLEMENT USE, INDIVIDUAL
HEALTH BEHAVIORS AND EXPOSOMES,
THE ENVIRONMENTAL EXPOSURES THAT
MAY INFLUENCE HEALTH AS WELL.
NEXT SLIDE PLEASE.
SECOND RESEARCH PROGRAM IS
POPULATION SCIENCES, NUTRITION
EPIDEMIOLOGY HAS BEEN A CRITICAL
COMPONENT SINCE INCEPTION, A
MAIN STAY FOR THE OFFICE, IT
WILL REMAIN A VITAL COMPONENT
MOVING FORWARD.
ESPECIALLY FOR IDENTIFYING
DEFICIENCIES IN THE AMERICAN
PUBLIC THAT MIGHT AFFECT HEALTH.
IT'S CRITICALLY IMPORTANT TO
CREATE COMPLETE PROFILE, NOT
ONLY ASSESSING DIETARY INTAKE
FROM FOODS AND BEVERAGES
NOT TO LEAVE OUT SUPPLEMENTS.
MORE THAN HALF OF THE U.S.
POPULATION REPORTS USING DIETARY
SUPPLEMENTS, THEY PLAY A ROLE
REGARDLESS OF EFFICACY AND
CANNOT BE OVERLOOKED.
THIS IS PARTICULARLY IMPORTANT
AS RELATES TO POPULATION WITH
HEALTH DISPARITIES.
MINORITY AND UNDERREPRESENTED
AND UNDERSERVED POPULATIONS.
IT IS IMPERATIVE DEMOGRAPHICS
ARE REPRESENTED IN SCIENTIFIC
RESEARCH SO RECOMMENDATIONS FOR
SPECIFIC SUBGROUPS CAN BE
DEVELOPED.
AND THIS IS JUST LIKE THE OFFICE
OF NUTRITION RESEARCH AND NIH'S
EFFORTS TO GET AWAY FROM A
ONE-SIZE-FITS-ALL APPROACH FOR
RESEARCH, WE'RE TAKING THE SAME
APPROACH TO UNDERSTAND
HETEROGENEITY AND RESPONSE TO
DIETARY SUPPLEMENTS AS WELL AS
OVERALL DIET.
THE FINAL PROGRAM IS ANALYTICAL
SCIENCES, TO ADVANCE STUDY OF
COMPOSITION, QUALITY,
STAKEHOLDER BECAUSE
THEY CONTAIN A MIXTURE OF
PRODUCTS AND BOTANICALS.
EVEN MARKETED WITH A SINGLE
BIOACTIVE NUTRIENT MAY BE QUITE
COMPLEX, MULTIPLE INGREDIENTS,
INSIPIENT INGREDIENTS WITHOUT
BIOLOGICAL EFFECT.
IF WE'RE GOING TO DESIGN
RESEARCH, HELPED COORDINATE
RESEARCH, PRODUCTS USED IN
INVESTIGATIONS ARE RIGOROUSLY
IDENTIFIED AND CHARACTERIZED.
THE OFFICE HAS BEEN DOING THIS
FOR QUITE A WHILE NOW.
THE KNOWLEDGE GAINED AND
RESOURCES DEVELOPED THROUGH
EXISTING PROGRAMS OF THE OFFICE
SPECIFICALLY ANALYTICAL METHODS
AND REFERENCE MATERIALS PROGRAM
AND A COLLABORATION WITH NCCIH,
CONSORTIUM FOR ADVANCING
RESEARCH ON BOTANICALS AND
NATURAL PRODUCTS, PROVIDES A
JUMP START TO IDENTIFY
INTEGRITY, RESEARCH GAPS WITH
FOCUS ON A NUMBER OF THINGS
LISTED IN THE BULLETS, WITH THE
OBJECTIVE OF ENSURING WHEN WE
STUDY DIETARY SUPPLEMENTS WE
KNOW WHAT WE'RE STUDYING.
MOVING INTO OUR CAPACITY
PROGRAMS, WE HAVE TWO, AND TWO
OBJECTIVES, STRAIGHTFORWARD, TO
DEVELOP BEST PRACTICES FOR
DIETARY SUPPLEMENT SCIENCE AND
IDENTIFY STRATEGIC FUNDING
MECHANISM TO STIMULATE EFFECTIVE
RESEARCH.
THE FIRST PROGRAM IS
METHODOLOGY.
DIETARY SUPPLEMENT RESEARCH IS
CELL CULTURE, ANIMAL AND
CLINICAL STUDIES,
POPULATION-BASED STUDIES WITH
NUMEROUS AREAS OF FOCUS.
ABILITY TO COMPARE, REPRODUCE,
REPLICATE PUBLISHED RESEARCH IS
ESSENTIAL FOR BUILDING CONSENSUS
AS WELL AS KNOWLEDGE BASE, AND
FOR RESEARCH THIS REQUIRES
DEVELOPMENT OF BEST PRACTICE
GUIDANCE, FOR METHODOLOGY AND
TECHNIQUES THAT CAN BE APPLIED
TO A VARIETY OF RESEARCH
PARADIGMS, WITH FOCUS ON
EXPERIMENTAL DESIGN,
INTERVENTION DEVELOPMENT,
MEASUREMENT, ANALYSIS, FINALLY
REPORTING IN PEER-REVIEWED
LITERATURE, WORKING WITH
COLLEAGUES AND PARTNERS TO
DEVELOP BEST PRACTICES AND WE'LL
SERVE AS RESOURCE FOR NIH FOR
IMPLEMENTATION OF THESE
PRACTICES.
THE OFFICE WILL DEVELOP
EQUITABLE POPULATION-BASED
RESEARCH DESIGNS AND DATA
COLLECTION TOOLS TO ENSURE
ADEQUATE REPRESENTATION OF
DIVERSE SUBPOPULATIONS AND
COMPREHENSIVE DATA COLLECTION IS
SEEN IN WHAT WE DO GOING
FORWARD.
THIS AREA IN TERMS OF
METHODOLOGY WILL BE AN AREA WE
START RIGHT AWAY.
WE HAVE ABILITY AND KNOW-HOW TO
DO THIS, AND WILL WORK WITH
DPCPSI OFFICES AND I.C.S RIGHT
AWAY TO BETTER THE FIELD OF
DIETARY SUPPLEMENT RESEARCH.
RESEARCH FUNDING STRATEGY
PROGRAM IS BUILT ON ODS STRONG
HISTORY OF PARTNERSHIP WITHIN
NIH.
ACROSS THE FEDERAL GOVERNMENT.
GOING FORWARD THE OFFICE WILL
SEEK TO INCREASE ITS FOCUS ON
COORDINATING AND INITIATING
COLLABORATIONS ACROSS NIH.
CRITICAL FACTOR WILL BE
IDENTIFICATION OF BEST POSSIBLE
FUNDING MECHANISM AVAILABLE FOR
FACILITATING EFFICIENT RESEARCH.
THIS IS NOT A NEW FOCUS FOR ODS
BUT NEW IN THE SENSE WE'RE
LOOKING TO BOOST CAPACITY AS
COORDINATING OFFICE.
WE HAVE USED FUNDING MECHANISMS
TO CO-FUND RESEARCH IN THE PAST,
THE FOCUS OF THIS PROGRAM WILL
BE USE KNOWLEDGE TO BEING AT THE
GROUND LEVEL OF STIMULATING
SCIENCE TO COORDINATE EFFORT TO
HELP PULL I.C.s TOGETHER TO
ADDRESS CONTEMPORARY ISSUES .
WE AIM TO DIVERSIFY FUNDING
APPROACHES ACROSS PROGRAMS, AND
WE'LL TRAIN ODS STAFF IN
DEVELOPMENT OF NIH FUNDING
OPPORTUNITIES, CONTRACT
DEVELOPMENT, INTERAGENCY
AGREEMENTS AND TRANSACTIONAL
AUTHORITIES.
STREAMLINED FUNDING PROCESS
WE'LL COORDINATE ODS-WIDE
PROCESSES FOR DETERMINING
FUNDING AWARDS AND GATHER
RESEARCH PROGRESS AND FINDINGS
TO HELP INFORM RETURN ON
INVESTMENT EVALUATION FOR OUR
SUPPORTED EFFORTS.
NEXT SLIDE.
WE HAVE OUR OPERATIONS AND
RESOURCES PROGRAMS, FOUR
OBJECTIVES HERE, INCLUDING
TRANSLATING AND DISSEMINATING
RESEARCH FINDINGS, SUPPORTING
DIETARY SUPPLEMENT DATABASES,
SUPPORTING USE OF PORTFOLIO
ANALYSES AND OTHER TOOLS
AVAILABLE TO US HERE AT NIH TO
EVALUATE RESEARCH BEING DONE,
AND COORDINATING COLLABORATIONS
AND PARTNERSHIPS WITHIN NIH AND
OTHER FEDERAL AGENCIES.
NEXT SLIDE.
SCIENCE AND HEALTH
COMMUNICATIONS, TO ACHIEVE OUR
MISSION IT'S IMPORTANT -- THE
IMPORTANCE OF SCIENCE AND
HEALTH -- TO ACLEAVE ITS
MISSION, IMPORTANCE CANNOT BE
OVERSTATED.
COMMUNICATING AND TRANSLATING IS
KEY TO OUR AUDIENCES.
IT'S BEEN WOVEN INTO THE GOALS
AND OUTPUTS OF OUR OFFICE FOR
THE PAST SEVERAL YEARS.
COMMUNICATION ACTIVITIES IN THE
OFFICE WILL FOCUS ON INFORMING
ODS AUDIENCES ABOUT THE WORK AND
ACCOMPLISHMENTS OF THE OFFICE,
AM PLY FIG -- AMPLIFYING WHAT WE
DO, IMPROVING RESOURCES TO
SUPPORT THE GOAL OF
COMMUNICATING ADVANCES AND
MAKING SURE OUR MESSAGE GETS OUT
TO THE RIGHT AUDIENCES AND THEY
ARE USING MESSAGES EFFECTIVELY.
LASTLY TO SUPPORT ODS
ACTIVITIES.
NOT JUST WHEN ACTIVITY IS DONE
BUT AT THE PLANNING STAGES,
KNOWING WHAT WE NEED TO
UNDERSTAND AND GET OUT TO THE
PUBLIC, HELPING MESSAGE ACROSS
ICOS AND FEDERAL PARTNERS AND
GET THE INFORMATION TO THE
PUBLIC.
NEXT SLIDE.
DATABASES IN TERMS OF DIETARY
SUPPLEMENTS, PROVIDING DETAILED
INFORMATION ON SUPPLEMENTS AND
INGREDIENTS AS WELL AS RESEARCH
BEING CONDUCTED ON THESE
SUPPLEMENTS.
THESE DATABASES USED BY RESEARCH
POLICYMAKERS AND THE PUBLIC
INCLUDE DATABASES SUCH AS
DIETARY SUPPLEMENT LABEL
DATABASE, DIETARY SUPPLEMENT
AGREEMENT DATABASE IN
COLLABORATION WITH USDA,
COMPUTER ACCESS TO RESEARCH ON
DIETARY SUPPLEMENTS, CARDS
DATABASE, RECORD OF FEDERALLY
FUNDED RESEARCH ON DIETARY
SUPPLEMENTS.
WE'LL MAINTAIN DATABASES,
ENSURING THE PUBLIC IS ABLE TO
USE THEM EFFECTIVELY.
NEXT SLIDE PLEASE.
THIS IS THE LAST SLIDE OF THE
PRESENTATION.
WHAT WE HAVE HERE IS OUR
MANAGEMENT AND ADMINISTRATIVE
SUPPORT.
THE PROGRAM HERE WILL AIM TO
BOLSTER EFFICIENCY,
ACCOUNTABILITY, AND THE
PRODUCTIVITY AS A COORDINATING
OFFICE IN DPCPSI.
THIS WILL INCLUDE SUPPORTING
WORKSHOPS, EXPERT PANEL
DISCUSSIONS, SUPPORTING
WORKFORCE DEVELOPMENT.
BUDGET FORECASTING, PROGRAM
ANALYSIS AND EVALUATION AND ALL
DAY-TO-DAY ADMINISTRATIVE ACTION
TO MAKE SURE WE CAN FUNCTION.
NEXT SLIDE PLEASE.
THAT TAKES CARE OF MY
PRESENTATION TODAY.
SHORT AND TO THE POINT.
I HOPE YOU -- I HOPE HE
DEMONSTRATED THROUGH THE BRIEF
DESCRIPTION PRIORITIES AND GOALS
FOR THE OFFICE MOVING FORWARD.
I BELIEVE THAT I'M CONFIDENT
THAT THE LAYERS OF THIS PROGRAM
WITHIN OFFICE AND OVERLAP WILL
ESTABLISH A BLUEPRINT FOR FUTURE
RESEARCH THAT IN THE END WILL
INFORM PUBLIC HEALTH.
I WANT TO THANK THE COUNCIL FOR
TIME AND ATTENTION AND EVERYONE
IN ATTENDANCE TODAY.
I WELCOME QUESTIONS AND FEEDBACK
ABOUT WHAT THE OFFICE IS DOING
OVER THE NEXT FIVE YEARS.
THANK YOU.
>> HE'S BEEN BUSY FOR THE LAST
YEAR TRYING TO DEVELOP OUT THIS
VISION AND PLAN AND DO SO IN A
REALLY COLLABORATIVE WAY TO
ENHANCE THAT FUNCTION OF THE
OFFICE GOING FORWARD.
SO LET ME TURN IT OVER TO THE
COUNCIL TO SEE IF THERE ARE ANY
QUESTIONS IN PARTICULAR ABOUT
THE PLAN AND THE VISION THAT
STEPHAN LAID OUT.
ALL RIGHT.
I SEE ONE HAND AND ONE QUESTION.
KENT FIRST.
>> I CAN'T FIND THE HAND RAISING
THING.
SORRY FOR WRITING.
THANKS FOR YOUR PRESENTATION.
A FEW QUICK THINGS.
SO 94 IS WHEN THE OFFICE WAS
ESTABLISHED, THAT'S 30 YEARS.
CAN YOU JUST IDENTIFY ONE OR TWO
OF THE MAJOR IMPACTS THE OFFICE
HAS HAD OVER THE LAST 30 YEARS?
>> THERE'S A LOT OF THEM.
THE OFFICE HAS BEEN AT THE
FOREFRONT OF ADVANCING THE
FIELD.
THAT COULD BE A COUPLE QUICK
EXAMPLES, UNDERSTANDING WHAT'S
IN THAT THE PRODUCTS,
BOTANICALS, HOW TO CHARACTERIZE
THOSE, IMPORTANTLY UNDERSTANDING
HOW THEY MAY IMPACT HEALTH.
UNDERSTANDING VITAMIN D,
STANDARDIZING VITAMIN D
ASSESSMENT IN TERMS OF
BIOMARKERS IN SUPPLEMENT USE,
ANOTHER MAIN OUTCOME.
ANOTHER IMPORTANT FACTOR THAT
MIGHT BE OVERLOOKED IN TERMS OF
WHAT GETS DONE, WE INFORM
DIETARY POLICY.
THE WORK WE DO IN COLLABORATION
WITH NCI AND CDC REALLY HELPS
UNDERSTAND WHAT THE AMERICAN
PUBLIC IS EATING, UNDERSTANDING
TRENDS IN SUPPLEMENT USE AS
RELATES TO NUTRIENT INTAKE, HOW
TO ANALYZE DATA TO GIVE A
COMPLETE NUTRIENT PROFILE,
INFORMING GUIDELINES FOR
AMERICANS.
THERE ARE MANY MORE.
PROVIDING CRITICAL INFORMATION,
ONE EXAMPLE WOULD BE PRENATAL
VITAMINS, MULTI-VITAMINS.
THE REASON DATABASES IS
IMPORTANT DIETARY SUPPLEMENTS
SAY THEY HAVE CERTAIN THINGS IN
THEM, OUR DATABASES UNDERSTAND
WHAT'S ACTUALLY IN THEM.
WE ANALYZE INGREDIENTS AND
REPORT ON THEM.
THE AMERICAN PUBLIC KNOW WHAT IS
THEY ARE TAKING.
>> I APPRECIATE THAT.
I WAS TRYING TO -- I WAS
IMPRESSED, YOU DID NOT MENTION
FDA.
FDA DOESN'T REGULATE -- IT
REGULATES SUPPLEMENTS, DOESN'T
APPROVE THEM FOR DISEASE OR
DISEASE TREATMENTS.
MY QUESTION IS BASED ON THE FACT
IT APPEARS AS THOUGH THE OFFICE
IS SUPPORTING, YOU PLAN TO
SUPPORT MORE RESEARCH TO
EVALUATE EXISTING SUPPLEMENTS I
GUESS ON THE MARKET.
AND YET IT WON'T HAVE ANY
REGULATORY EFFECT OR APPROVAL IN
TERMS OF ABILITY TO SELL THESE
SUPPLEMENTS.
SO WHICH WOULD SEEM WHAT YOU'RE
TRYING TO DO IS WHAT FDA SHOULD
BE DOING, IF YOU WANT TO SEE ARE
THESE THINGS GOOD OR BAD, AND
SHOULD THEY BE USED OR SHOULDN'T
BE USED, IT'S MY OWN NAIVETE OF
UNDERSTANDING, YOU KNOW, WHY
ISN'T FDA DOING THIS AS OPPOSED
TO NIH DOING THIS.
>> WELL, WHEN THE LAW WAS PASSED
IN 94, THEY DELINEATED ROLES
BETWEEN FDA AND NIH.
OUR JOB WAS FACILITATE RESEARCH,
AND THEY HELD THE OTHER SIDE OF
THE EQUATION, WHICH IS TO THE
EXTENT WHICH THEY ARE REGULATED
AND OVERSEEN BY THE FDA.
WE WORK WITH THE FDA, WE WORK IN
CLOSE RELATIONSHIP WITH THEM,
OD-S, THEY COMMUNICATE AND HELP
WHAT WE DO, I UNDERSTAND YOUR
CONCERN IT DOESN'T END IN THEIR
RECOMMENDATION OF A PRODUCT OR
NOT BUT THERE IS SYNERGY BETWEEN
THE TWO ORGANIZATIONS AND WE DO
WORK CLOSELY TOGETHER.
>> GENERALLY SPEAKING, NOT JUST
ODS IN PARTICULAR, BUT NIH BEING
THE RESEARCH ARM, WE PROVIDE
EVIDENCE BASE THAT INFORMS
DECISION MAKING, FDA CAN UTILIZE
THAT, AS APPROPRIATE WHAT IS
RELEVANT FOR THEIR WORK.
IT'S KIND OF COMPLICATED AS
MENTIONED.
I SEE A NUMBER OF HANDS.
WE'LL GO RHONDA, RAFAEL, LAUREN.
>> CAN YOU HEAR ME?
>> YES.
>> FIRST THAT WAS A FANTASTIC
PRESENTATION.
I LEARNED A LOT ABOUT WHAT
YOU'RE INTENDING TO DO, AND IT
WAS HUGE.
THERE ARE SEVERAL QUESTIONS I
HAD.
I HAD A QUESTION ABOUT THE FDA
AFFILIATION.
I THINK YOU HAVE ARTICULATED
THAT.
HERE'S WHAT I'M HEARING, OF
GREAT IMPORTANCE, PARTICULARLY
SINCE WE'RE TALKING ABOUT A $60
BILLION A YEAR INDUSTRY.
BUILDING A STRONG INVESTMENT IN
THE PRIVATE SECTOR, 50%-PLUS,
DEPENDING ON AGE OF INDIVIDUALS
USING THIS.
THIS IS A HUGE AREA THAT HAS
POTENTIAL TO HAVE TREMENDOUS
POSITIVE AND NEGATIVE IMPACT ON
THE POPULATION.
YOU TALKED ABOUT HAVING A
DATABASE AND EDUCATION.
I'M TRYING TO UNDERSTAND WHERE
YOUR PRIORITIES ARE FOR
SHORT-TERM TURNAROUND, ONE HAS
TO DO WITH PUBLIC EDUCATION AS
RELATES TO WHAT YOU'RE DOING TO
RESEARCH EXISTING SUPPLEMENTS
OUT THERE.
THAT'S EXCEPTIONALLY POWERFUL.
I HOPE IT'S TOP ON YOUR LIST IN
TERMS OF TURNING OVER
INFORMATION THAT CAN BE
AVAILABLE TO THE PUBLIC.
THE OTHER THING I WORRY ABOUT IS
SUSTAINABILITY.
WE'RE IN A ERA WHERE FUNDING
GETS CUT AFTER A PERIOD OF TIME,
AND WONDERING WHETHER OR NOT
THERE'S SUSTAINABILITY PLAN
PARTICULARLY WHEN YOU DEAL IN AN
AREA THAT HAS VERY STRONG AND
LARGE AMOUNTS OF PRIVATE SECTOR
INVESTMENT.
IS THERE ANY THOUGHT ABOUT HOW
TO USE SOME OF THAT TO HELP
BOLSTER AND SUPPORT
SUSTAINABILITY?
I THOUGH THAT SOUNDS WEIRD BUT I
THINK IT'S SOMETHING THAT AS A
GOVERNMENTAL AGENCY IS SOMETHING
THAT NEEDS TO BE ENTERTAINED IN
THOUGHT.
THANK YOU.
>> THANKS FOR THOSE COMMENTS AND
QUESTIONS.
LET ME TACKLE THE FIRST PART.
WHAT YOU HEARD, THANK YOU FOR
THE POSITIVE FEEDBACK ON THE
STRATEGIC PLAN.
IT'S BEEN A BUSY NINE MONTHS AS
TARA MENTIONED.
THE GOOD THING, I TALKED ABOUT
THE FUTURE.
WE HAVE A LOT OF ONGOING WORK,
THE OFFICE HAS BEEN AROUND 30
YEARS, EXISTING PROGRAMS
CONTINUE TO PLUG AWAY AT THEIR
OBJECTIVES.
ONE IMPORTANT ASPECT IS
EDUCATION.
GETTING INFORMATION TO THE
PUBLIC.
WE HAVE A SET OF RESOURCES ON
NUTRIENTS, DIETARY SUPPLEMENTS,
USE OF THEM, ON OUR WEBSITE,
HEAVILY ACCESSED, FDA RELIES ON
WHAT WE PUT OUT THERE.
WE PUT ON EDUCATION SERVICES FOR
ACADEMICS, CONSUMERS,
PRACTITIONERS, THAT'S BY WAY OF
RESEARCH PRACTICUM EVERY YEAR,
WE MOVE THAT TO EVERY OTHER
YEAR, THAT'S HELD IN MAY, TO
EDUCATE PEOPLE ON THE FIELD OF
DIETARY SUPPLEMENTS TO USE IN
THE AMERICAN PUBLIC.
THAT WON'T GO AWAY.
WE WORK CLOSELY TO FUND AND
DEVELOP SCHOLARS IN THIS AREA.
WE'LL LOOK TO DO MORE, TO BRING
IN JUNIOR SCIENTISTS AND
PRE-DOCTORAL FELLOWS TO GET
ENGRAINED AND ENTRENCHED IN
UNDERSTANDING THE FIELD.
THAT'S KEY TO WHAT WE DO.
IN TERMS OF NEAR-TERM WINS WE'LL
CONTINUE, WE HAVE A COUPLE
THINGS, NEAR--TERM LOW-HANGING
FRUITS, EFFORTS AREN'T SMALL.
I MENTIONED ONE BEING AN EFFORT
OR CONCEPT TO DEVELOP NEW
GUIDELINES OF PRACTICES FOR
DIETARY SUPPLEMENT SCIENCE.
THERE'S THIS IDEA OR NOTION
BECAUSE IT'S NOT A DRUG STUDY
NUTRITION AND DIETARY SUPPLEMENT
SCIENCE IS NOT AS COMPLEX AND
RIGOROUSLY CONTROLLED.
A FIELD HAS HOLES IN IT,
HOPEFULLY THAT WILL IMPROVE
FUNDING DECISIONS AND IN TURN
HELP IMPROVE THE RESEARCH THAT
GETS PUBLISHED, SOME NEAR--TERM
SMALL WINS WE'RE TRYING TO DO.
SUSTAINABILITY, LEVERAGING OR
WORKING WITH THE PUBLIC TO
LEVERAGE FUNDS IN CASE WE'RE
REDUCED IN FUNDS, IS THAT WHAT
YOU'RE GETTING AT?
I WASN'T CLEAR.
>> MORE ALONG THE LINE YOU HAVE
UNIQUE CAPABILITY OF
RESEARCHING, VERIFYING VALIDITY
OF A SUPPLEMENT IN SOME WAY.
I KNOW THERE ARE LABS OUT THERE
THAT DO THAT BUT I DON'T KNOW
WHETHER OR NOT -- AS A MATTER OF
FACT MOST SUPPLEMENTS DON'T GO
THROUGH THE LACKS.
AS YOU BUILD GUIDELINES AND
INFRASTRUCTURE THERE'S AN
OPPORTUNITY TO CONSIDER WHAT
YOUR STAMP OF APPROVAL OR WHAT
YOU'RE EXPECTING YOUR RESOURCES
TO RESEARCH CAN DO TO HELP BRING
THE INVESTORS IN THESE
SUPPLEMENTAL COMPANIES UNDER
YOUR WING SO WE HAVE VIABLE AND
USEFUL INFORMATION AND NOT JUST
WORD OF MOUTH FROM SOMEONE WHO
DIDN'T REALLY --
>> I GET IT.
>> OKAY.
>> WE LIVED ON THIS FOR PROBABLY
20 YEARS NOW, AT THIS POINT.
I MENTIONED ANALYTICAL REFERENCE
MATERIALS PROGRAM LED BY DR.
ADAM CUSACK, BASICALLY THE
DIETARY SUPPLEMENT INDUSTRY,
WHAT'S IMPORTANT TO THEM,
PRODUCTS ON THE MARKET, WHERE
ARE WE MISSING THE ABILITY, WE
WORK WITH OTHER LABORATORIES, TO
MAKE SURE WE'RE ADDRESSING
APPROPRIATE QUESTIONS SO THAT
THE AMERICAN PUBLIC CAN HAVE
SOME CONFIDENCE THAT THEY'RE
TAKING IS THEY SAY THEY ARE
TAKING.
WE PARTICIPATE IN PROFESSIONAL
SOCIETIES THAT OVERSEE THAT KIND
OF WORK REGULARLY AND WE'RE
CONTINUING TO ADVANCE THAT WORK.
THAT'S ONE PIECE OF THE COG OF
IMPROVING THE METHODS AND RIGOR
AND CONFIDENCE IN DIETARY
SUPPLEMENT SCIENCE AND WE'LL SEE
IT MOVING FORWARD.
>> LAUREN, YOU'RE THE FINAL
QUESTION, WITH INSIGHT FROM YOUR
PREVIOUS ROLE AT FDA.
>> I COULDN'T HELP MYSELF.
I APPRECIATE THE COMMENTS ABOUT
THE COORDINATION WITH FDA
INCLUDING FROM YOU, TARA.
IN THE MESSAGING, SORRY ABOUT
THE DOG IN THE BACKGROUND, I
WOULD JUST -- SO SORRY.
I WOULD JUST -- YOU KNOW, IN
YOUR METHOD OF COMMUNICATION BE
THOUGHTFUL ABOUT NOT GIVING THE
IMPRESSION OF SAFETY FROM NIH
PERSPECTIVE WHEN FDA'S
AUTHORITIES IN THIS AREA ARE
LIMITED.
PUTTING INFORMATION FOR
CONSUMERS IS IMPORTANT
RECOGNIZING IT'S NOT REGULATED
BY DRUGS.
THERE ARE MORE LIMITED
AUTHORITIES.
I THOUGHT IT WAS A STRONG AND
THOUGHTFUL STRATEGIC PLAN,
PARTICULARLY SOMEONE NEW COMING
IN.
I WAS VERY IMPRESSED BY HOW
COMPREHENSIVE AWAY.
THE LAST THING, HOW YOU'RE GOING
TO TAKE ON MORE CONTROVERSIAL
FROM A REGULATORY PERSPECTIVE
ISSUES, SUPPLEMENTS, OR
INGREDIENTS THAT ARE COMMONLY
FOUND IN COMPLEMENTS THAT MAY
NOT BE AUTHORIZED, CBD, AN
OBVIOUS EXAMPLE, MORE WIDELY
YOU'VE, NOT AUTHORIZED TO BE IN
SUPPLEMENTS, HOW YOU'RE TACKLING
SOMETHING LIKE THAT.
>> WELL, THANK YOU FOR THE
POSITIVE FEEDBACK ON THE
STRATEGIC PLAN AND FOR SOME OF
THE POINTS OF CLARITY WITH FDA.
I GET IT.
SAFETY IS THIS WEIRD TERM, IN
THE CONTEXT OF NIH, IT'S NOT OUR
NAME WHEN YOU THINK ABOUT THE
CONTEXT OF REGULATORY, AND TO
WHAT AUTHORITY FDA CAN COMMENT
ON THIS SO I GET IT.
HOW DO WE ADDRESS THAT?
CBD BECAUSE OF FDA RULING OR
STANCE ON CBD IS NOT SOMETHING
WE'RE ENTERTAINING.
I DO SEE THAT EVOLVING.
THERE'S NO WAY TO GET AROUND IT
NCCIH HAS A PRETTY SIGNIFICANT
WORK GOING INTO THAT AREA, CBD,
BUT HOW THAT BLEEDS INTO DIETARY
SUPPLEMENTS AND WHERE WE PLAY A
ROLE I'M THE NEW SURE.
IT WILL BE CAREFULLY THOUGHT YOU
THE TO MAKE SURE WE'RE STAYING
IN OUR LANE, WHAT'S SPELLED OUT
IN THE OLD 1994 LAW, DSHEA LAW.
IT'S A NON-ANSWER BUT BEST I CAN
DO.
>> A FAIR ANSWER.
I WONDERED IF YOU THOUGHT ABOUT
THAT.
>> MORE TO COME ON THAT, I'M
SURE, FROM VARIETY OF
PERSPECTIVES.
I WANT TO MAKE SURE WE SAVE TIME
FOR OUR LAST CONVERSATION, SO I
WILL THANK STEFAN FOR HIS
PRESENTATION.
WE'LL SHIFT GERBES -- GEARS TO
THE NEW EFFORT THE WHITE HOUSE
HAS BEEN PUSHING FORWARD AND
SUPPORTING, WHICH IS THE WOMEN'S
HEALTH RESEARCH INITIATIVE, SO
DR. VIVIAN OTA WANG WHO YOU
HEARD ABOUT EARLIER THIS
MORNING, THE RELATIVELY NEW
DEPUTY DIRECTOR OF OFFICE OF
RESEARCH ON WOMEN'S HEALTH IS
HERE TO TALK ABOUT THE WORK THEY
ARE DOING TO HELP USHER THAT IN,
IN RESPONSE TO THE EXECUTIVE
ORDER IN MARCH.
WITH THAT, VIVIAN?
>> THANK YOU, TARA, FOR THE NICE
INTRODUCTION.
GOOD AFTERNOON, EVERYONE.
SO WHAT I WOULD LIKE TO DO IS,
NEXT SLIDE, IS PROVIDE SOME
CONTEXT ABOUT WOMEN'S HEALTH AND
WE'RE GOING TO LAUNCH INTO
REALLY MORE DEPTH OF THE WHITE
HOUSE'S INITIATIVE ON WOMEN'S
HEALTH RESEARCH.
JUST WANTED TO REMIND EVERYONE
AS WE START THINKING ABOUT
HEALTH, THAT MEN AND WOMEN
FOLLOW DIFFERENT PATHS TO HEALTH
AND DISEASE.
WE MAY HAVE A STARTING POINT
THAT MAY APPEAR TO BE THE SAME
BUT REALLY DEPENDING ON OUR
GENETICS, OUR BIOLOGY, SOCIAL
ENVIRONMENTS WE LIVE, THAT OUR
PATHS TO DISEASE AND HEALTH HAVE
DIFFERENT ENDPOINT.
NEXT SLIDE PLEASE.
WOMEN DIFFERENTLY EXPERIENCE
HEALTH AND DISEASE.
ON THE LEFT IS FEMALES AND MALES
ON THE RIGHT, YOU'RE GOING TO
NOTICE BASED ON AGE WOMEN --
FEMALES AND MALES EXPERIENCE
HEALTH DIFFERENTLY BASED ON
FREQUENCY, BASED ON MAGNITUDE,
NUMBER OF DISEASES THAT THEY ARE
EXPERIENCING.
SO FOR EXAMPLE IF YOU LOOK AT
THE DARK BLUE ON THE LEFT,
YOU'LL SEE FEMALES EXPERIENCE --
DARK BLUE IS SEROLOGIC DISEASE,
EXPERIENCES EARLIER AND MORE
FREQUENTLY THROUGHOUT THEIR LIFE
THAN MEN.
WE CAN ALSO LOOK AT THE PINK
AREA, THAT'S THE MUSCULOSKELETAL
DISEASES.
THERE'S ALSO A HIGHER FREQUENCY
AND LONGER EXPERIENCE OF THESE
DISEASES AS WELL.
AND FOR ME IT'S JUST TO SHOW
CONTEXT OF HOW WE'RE THINKING
ABOUT WOMEN'S HEALTH RESEARCH
THAT FOR THE OFFICE OF RESEARCH
ON WOMEN'S HEALTH WE'RE LOOKING
AT THE LIFESPAN, THE ENTIRE
LIFESPAN OF WOMEN.
NEXT SLIDE PLEASE.
AND THIS IS TO ILLUSTRATE THIS
IS NOT A NEW ISSUE FOR THE
NATIONAL INSTITUTES OF HEALTH.
WE'VE HAD AN ENDURING AND ROBUST
COMMITMENT AND INTEREST IN
WOMEN'S HEALTH RESEARCH.
ON THE LEFT IT'S BEEN EMBEDDED
IN A STRATEGIC PLAN NOT ONLY IN
TERMS OF NAGS NATIONAL
INSTITUTES OF HEALTH BUT OFFICE
OF RE RESEARCH ON WOMEN'S HEALT.
WE'VE PARTNERED WITH THE FORMER
BILL AND MELINDA GATES
FOUNDATION AS WELL AS NATIONAL
ACADEMIES TO GET INFORMATION AND
DATA ABOUT THE STATUS OF WOMEN'S
HEALTH RESEARCH AND WOMEN'S
HEALTH.
AND THEN IMPORTANTLY I'LL END
THE DISCUSSION TODAY, WE'RE
IMPORTANTLY PARTNERING WITH U.S.
GOVERNMENT-RELATED SISTERS AND
BROTHERS AS WELL AS RELATED
DIRECTIVE.
NEXT SLIDE PLEASE.
SO OUR FOUNDATION IS REALLY THE
NIH-WIDE STRATEGIC PLAN.
AND I WANTED TO ILLUSTRATE THAT
AS YOU KNOW THE NIH STRATEGIC
OBJECTIVES ARE AROUND RESEARCH
AREAS, RESEARCH CAPACITY,
RESEARCH CONDUCT.
BUT REALLY WANTED TO ONCE AGAIN
BRING TO YOUR ATTENTION THAT
WOMENS HEALTH IS ONE OF THE
CROSS-CUTTING THINKS THE
-- THEMES THE
NATIONAL INSTITUTES OF HEALTH IS
IDENTIFIED FOR BEING IMPORTANT
FOR THE WORK AND THINKING WE'RE
DOING.
NEXT SLIDE PLEASE.
HOW DOES THIS FIT WITH OFFICE OF
RESEARCH ON WOMEN'S HEALTH?
PART OF THAT CROSS-CUTTING
VISION OF NIH WAS REALLY TRYING
TO FOCUS NIH'S VISION ON SEX AND
GENDER INTEGRATED INTO
BIOMEDICAL RESEARCH AS A GENERAL
PRINCIPLE.
WITH THE UNDERSTANDING THAT
EVERY WOMAN TRULY RECEIVES
EVIDENCE-BASED CARE AND WE NEED
TO INVEST IN WOMEN AND SCIENCE
CAREERS TO REACH FULL POTENTIAL,
NOT ONLY IN EARLY PART OF THE
CAREER BUT THROUGHOUT THE SENIOR
PART OF THEIR CAREER AS WELL.
WE'RE DOING THAT THROUGH OFFICE
OF RESEARCH ON WOMEN'S HEALTH,
OUR MISSION IS TO EXPAND AND
ENHANCE WOMEN HELLS RESEARCH,
WE'RE KEEN ON INCLUDING WOMEN
AND MINORITY GROUPS IN CLINICAL
RESEARCH, AND AS WELL AS
PROVIDING PROGRAMS AND FUNDING
RESOURCES TO PROMOTE CAREER
DEVELOPMENT FOR WOMEN IN
BIOMEDICAL CAREERS.
NEXT SLIDE PLEASE.
SO I WANTED TO BRING TO YOUR
ATTENTION THAT THIS IS OUR NEWLY
RELEASED 2024 TO 2528 NIH-WIDE
STRATEGIC PLAN FOR WOMEN'S
HEALTH RESEARCH.
IT WAS JUST RELEASED A COUPLE
WEEKS AGO.
AND I JUST WANTED TO BRING -- TO
HIGHLIGHT TRAINING AND EDUCATION
AND RESEARCH IS OUR FOUNDATION
TO THE WORK THAT WE'RE DOING.
AND IN THE STRATEGIC PLAN WE'RE
FOCUSING ON DATA SCIENCE AND
MANAGEMENT, WE'RE LOOKING AT THE
BENCH TO BEDSIDE BY BASIC AND
TRANSLATIONAL RESEARCH, █AND
INCORPORATING COMMUNITY
ENGAGEMENT AS AN ESSENTIAL
RESOURCE TO THE WORK THAT WE'RE
DOING.
NEXT SLIDE PLEASE.
SO PART OF THE RESEARCH IS WE'RE
REALLY TRYING TO TRANSFORM
WOMEN'S HEALTH THROUGH THE
LIFESPAN.
YOU HEARD EARLY WITH DR.
BIANCHI, THAT PUNCUATES MATERNAL
HEALTH ISSUES THAT NICHD HAS
BEEN THE LEADER IN THINKING AND
DOING OF THAT.
LOOKING IN ADDITION TO THOSE
PUNCTUATED EFFORTS, THROUGHOUT
THE LIFESPAN OF A WOMAN HOW
INTERSECTION OF BIOLOGICAL
FACTORS BUT LOOKING AT
INTERACTION OF SOCIAL FACTORS AS
WELL THAT AFFECT WOMEN'S HEALTH.
WE'RE GOING TO BE DOING THAT
THROUGH INNOVATIVE RESEARCH
METHODS AND DEVELOPMENT, THROUGH
WHAT YOU HEARD EARLIER ABOUT
SOME WAYS THAT WE'RE DOING IT IN
DATA SCIENCE, AND PROMOTING
CUTTING EDGE TECHNOLOGIES.
TO DO THAT, WE'RE ALSO
SUPPORTING BIOMEDICAL WORKFORCE
TRAINING AND CAREER DEVELOPMENT,
IN THAT WAY WE COULD FULLY
ADVANCE BASIC SCIENCE AND
TRANSLATIONAL RESEARCH TO
IMPROVE THE HEALTH OF WOMEN.
AND LAST BUT NOT LEAST IS THAT
PART OF OUR BEDROCK IS COMMUNITY
ENGAGEMENT, AND THAT IS ONE OF
THE WAYS WE'RE PROMOTING
IMPLEMENTATION SCIENCE FOR THIS
AREA.
NEXT SLIDE PLEASE.
HERE WE GO.
SO, I'M JUST TO GIVE A WHIRLWIND
TOUR OF THE WHITE HOUSE
INITIATIVE.
A SNAPSHOT OF HOW BUSY WE'VE
BEEN, THE WHITE HOUSE RESEARCH
INITIATIVE WAS ANNOUNCED LAST
NOVEMBER, NOVEMBER 13, WHERE THE
PRESIDENT SIGNED THIS
MEMORANDUM.
THAT STARTED A CLOCK FOR THE
NATIONAL INSTITUTES OF HEALTH,
WE HAD TO FIGURE OUT WHAT ARE
SOME WALES WE'RE GOING TO THINK
ABOUT WOMEN'S HEALTH RESEARCH,
AS YOU CAN SEE WE HAD A
DEADLINE.
YOU CAN IMAGINE HOW MANY OF US
SPENT BETWEEN THANKSGIVING AND
THE END OF THE YEAR TRYING TO
REALLY DISCUSS WITH INSTITUTE
DIRECTORS WITH BRAINSTORMING
SESSIONS, WE DID DATA CALLS TO
FIGURE OUT WHAT ARE THE
ACTIVITIES WE'RE DOING ACROSS
NIH.
AND WE TRIED TO FIGURE OUT WHAT
WOULD BE THE BEST WAY FOR US TO
THINK ABOUT WOMEN'S HEALTH
RESEARCH AS WE MOVE FORWARD WITH
THIS MEMORANDUM THAT REALLY
LAUNCHED THE INITIATIVE.
NEXT SLIDE PLEASE.
SO IN MARCH, PRESIDENT BIDEN HAD
THE EXECUTIVE ORDER 14120,
ADVANCING WOMEN'S HEALTH
RESEARCH AND INNOVATION.
IT'S TRULY THE MOST
COMPREHENSIVE SET OF EXECUTIVE
ORDERS TO EXPAND AND IMPROVE
RESEARCH ON WOMEN'S HEALTH.
SOY AS YOU CAN SEE WE'VE HAD
LEADERSHIP INCLUDING DR.
BERTAGNOLLI AND OFFICE OF
RESEARCH ON WOMEN'S HEALTH
DIRECTOR DR. JANINE CLAYTON.
I WAS ALSO THERE WITH TARA
SCHWETZ AND OTHER LEADERS OF
NIH, A VERY EXCITING TIME.
IMPORTANTLY WHAT THE EXECUTIVE
ORDER IS TRYING TO FOCUS ON IS
INTEGRATING WOMEN'S HEALTH
ACROSS THE ENTIRE FEDERAL
RESEARCH PORTFOLIO TO DEVELOP
AND STRENGTHEN DATA STANDARDS IN
RELEVANT RESEARCH AND FUNDING
OPPORTUNITIES.
IT'S REALLY TRYING TO PRIORITIZE
INVESTMENTS IN WOMEN'S HEALTH,
REALLY LOOKING AT HIGH IMPACT
RESEARCH AND INNOVATION.
IMPORTANTLY, IT'S GALVANIZING
RESEARCH IN WOMEN'S MID-LIFE
HEALTH.
PEOPLE ASK HOW COME WOMEN'S
MIDLINE HEALTH?
WHAT WE KNOW ABOUT THIS PERIOD
OF LIFE IN WOMEN, IT'S ONE OF
THESE PIVOTAL POINTS WHERE A LOT
OF CHRONIC DISEASES ACTUALLY
EMERGE.
SO UNDERSTANDING RESEARCH GAP
THAT OCCUR AFTER MENOPAUSE AND
CONDITIONS AND DISEASES THAT ARE
ASSOCIATED WITH IT ARE REALLY AN
IMPORTANT PIECE OF THAT MISSING
PUZZLE.
AND PART OF THAT IS ALSO
COMMITMENT TO ASSESSING UNMET
NEEDS TO SUPPORT WOMEN'S HEALTH
RESEARCH NOT ONLY LOOKING AT
FEDERAL FUNDING BUT REALLY
FIGURING OUT IF THERE ARE
CHANGES WE NEED TO MAKE,
STATUTORY, REGULATORY, BUDGETARY
TO MAXIMIZE SUPPORT TO BROADEN
THE SCOPE OF WOMEN'S HEALTH
RESEARCH NEEDS ACROSS THE U.S.
GOVERNMENT.
NEXT SLIDE PLEASE.
THIS IS AN ILLUSTRATION, ACROSS
THE U.S. GOVERNMENT WE HAVE 11
PARTNERS, WHAT WE'RE DOING IS
WE'RE COLLABORATING THROUGH WHAT
WE CALL MULTI-AGENCY
CROSS-CUTTING PROGRAMS, AS A WAY
TO POTENTIALLY FUND
INTERDISCIPLINARY RESEARCH
HEALTH RESEARCH TOWARDS
TRANSFORMING WOMEN'S HEALTH
RESEARCH.
IT'S HIGHLIGHTING
INTERDISCIPLINARY RESEARCH, IN A
LOT OF WAYS THAT'S THE LIVED
EXPERIENCE OF WOMEN THAT WE HAVE
DIFFERENT FACTORS THAT INFLUENCE
OUR HEALTH THIS IS TRYING TO
SUPPORT RESEARCH REFLECTING THAT
REALITY.
A WE'RE TAKING A LIFE COURSE
APPROACH.
AN INTEGRATION OF BIOLOGICAL
FACTORS AND SOCIAL AND
ENVIRONMENTAL EXPOSURES AND
DETERMINANTS OF HEALTH.
AND THAT AS PART OF NIH'S
COMMITMENT, FY 2025, WE HAVE A
$200 MILLION EFFORT AS A WAY TO
CLOSE WOMEN'S HEALTH RESEARCH
GAPS ACROSS THE LIFESPAN BY
SUPPORTING NEW INTERDISCIPLINARY
RESEARCH THAT'S GOING ACROSS THE
TRADITIONAL NIH INSTITUTES AND
CENTERS.
AND SO YOU CAN IMAGINE WHAT
WE'RE TRYING TO DO IS TO
INTEGRATE SORT OF THAT
INTERSTITIAL SPACE OF WHERE
RESEARCH NESTS THAT DEPENDS ON A
LOT OF DISCIPLINES.
WE HAVE TIGER TEAM OF INSTITUTE
DIRECTORS CO-CHAIRED BY JANINE
CLAYTON AND DIRECTORS FROM
NATIONAL INSTITUTES OF AGING,
MUSCULOSKELETAL AND SKIN
DISEASE, EUNICE KENNEDY SHRIVER
INSTITUTE, DRUG ABUSE, A NICE
COMPLEMENT OF DIRECTORS THAT'S
LOOKING ACROSS THE DIASPORA OF
DISEASES THAT ARE DEEPLY
AFFECTING WOMEN'S HEALTH.
I WANT TO FOCUS ON SOME ACTIONS
WE'RE TAKING, ALIGNING EFFORTS
FOR EXECUTIVE ORDER
REQUIREMENTS.
SO, THE LISTING ON THE LEFT ARE
THE BROAD CATEGORIES.
WE WANT TO CREATE A FRONT DOOR
TO NIH FOR THE FUNDING
OPPORTUNITIES OF WOMEN'S HEALTH.
AND SO ONE OF THE FIRST THINGS
THAT WE'VE ALREADY DONE IS THAT
WE RELEASED A NOTICE OF
INTEREST, SPECIAL INTEREST,
NIH-WIDE FOR WOMEN'S HEALTH
RESEARCH.
ESSENTIALLY WHAT THIS DID IS WE
ATTACHED THIS NOSI TO ALL PARENT
FUNDING OPPORTUNITIES FOR NIH,
AND ALL OF THE INSTITUTES AND
CENTERS AND OFFICES HAVE SIGNED
ON TO THAT.
THIS IS ONE WAY TO SPREAD
DIASPORA ACROSS THE ENTIRE NIH,
WORKING ON STANDARDIZING DATA Y
TRYING TO DEVELOP AND IDENTIFY
NEW COMMON DATA ELEMENTS RELATED
TO WOMEN'S HEALTH, THAT WILL
HELP RESEARCHERS SHARE AND
COMBINE DATASETS, AND IMPROVE
ACCURACY AND RIGOR OF DATASETS.
IMPORTANTLY WE'RE SUPPORTING
INNOVATION THROUGH PRIVATE
SECTOR INNOVATION THROUGH THE
SMALL BUSINESS INNOVATION
RESEARCH PROGRAM AND SMALL
BUSINESS TECHNOLOGY TRANSFER
PROGRAM.
WE HAVE A COMMITMENT TO FURTHER
INCREASING UP TO 50% OF ITS
INVESTMENT IN RESEARCH AND
DEVELOPMENT ON WOMEN'S HEALTH.
WE'RE CREATING MENOPAUSE
RESEARCH AGENDA THROUGH THE
PATHWAYS TO PREVENTION SERIES,
THE NEXT SERIES ON
MENOPAUSE-RELATED ISSUES, THAT
WAS JUST ANNOUNCED A WEEK AGO AT
OUR NATIONAL WOMEN'S HEALTH
WEEK.
LAST, REALLY GOING BACK INTO
LOOKING AT WAYS TO IMPROVE THE
HEALTH OF WOMEN, EARLY DETECTION
AND TREATMENT.
ONE OF THE WAYS WE'RE DOING THAT
IS WE'RE GOING TO LOOK AT
BIOMARKER DISCOVERY AND
VALIDATION, TO LOOK ACROSS THE
DIASPORA OF PREVENTION,
DIAGNOSIS AND TREATMENT OF
CONDITIONS THAT UNIQUELY AFFECT
WOMEN.
NEXT SLIDE PLEASE.
THIS IS THE NOTICE I TALKED
ABOUT.
I WANTED TO GIVE IT TO YOU AS A
REFERENCE SO YOU CAN GO BACK TO
IT EASILY.
AND THAT THE FIRST AVAILABLE DUE
DATE FOR GRANTS WE'VE PASSED IT,
BEGINNING OF MAY.
NEXT SLIDE PLEASE.
THAT'S ALL I HAVE.
I'M HOPING I LEFT A LITTLE BIT
OF TIME FOR QUESTIONS OR
COMMENTS YOU MAY HAVE.
I WANT TO RECOGNIZE DR. TARA
SCHWETZ, WHO HAS BEEN AT OUR
SIDE THROUGH THICK AND THIN
TRYING TO GET THIS DONE, QUITE
AN ASSET FOR US.
THANK YOU, TASHA.
>> THANKS.
WE HAVE A COUPLE MINUTES FOR
QUESTIONS AND VERY SHORT CLOSING
REMARKS.
LET ME OPEN TO SEE IF ANYONE HAS
ANY QUESTIONS OR IF THAT WAS
JUST SO NICELY LAID OUT THAT
EVERYONE UNDERSTANDS.
LET'S SEE.
OBVIOUSLY THIS HAS BEEN A SPRINT
OF AN EFFORT I WOULD SAY OVER
THE LAST SIX OR SO MONTHS, AND
ORWH HAS BEEN LEADING THE CHARGE
ON A LOT OF THIS EFFORT BUT
WE'RE TRYING TO MAKE THIS A BIG
CROSS-CUTTING APPROACH, ACROSS
ALL OF NIH BECAUSE THIS IS A
TOPIC THAT COVERS ALL OF THE
DIFFERENT INSTITUTES AND
CENTERS.
AND THERE'S MUCH MORE TO COME ON
THIS BECAUSE THIS IS OBVIOUSLY A
PRIORITY OF THE ADMINISTRATION
AND SO WE'LL SEE HOW THINGS
SHAKE OUT MOVING FORWARD.
STILL NOT SEEING ANY COMMENTS OR
QUESTIONS IN THE CHAT OR ANY
HANDS UP.
WITH THAT, THANK YOU, VIVIAN,
FOR THAT GREAT OVERVIEW AND
PRESENTATION.
I THINK IT'S THE END OF THE DAY.
FOLKS ARE WANTING TO SIGN OFF.
LET ME JUST BRIEFLY SAY QUICKLY
THAT WE APPROVED TWO CONCEPTS
TODAY.
SO PHASE 2 OF THE SCGE COMMON
FINANCED PROGRAM AND FOR A NEW
TRAINING AND WORKFORCE EFFORT ON
ETHICAL A.I.
WE HEARD A LOT ABOUT VARIOUS
EFFORTS OF NICHD, DIETARY
SUPPLEMENTS, ORWH WHICH WE JUST
HEARD, AMONG OTHERS.
SO LOTS GOING ON HERE.
I ALSO NOTED A COUPLE TOPICS FOR
CONSIDERATION OF FUTURE COUNCIL
MEETINGS, THAT INCLUDES LEARNING
MORE ABOUT THE IMPROVE PROGRAM
ON MATERNAL MORBIDITY AND
MORTALITY, AND THE NEW ERA
INITIATIVE TO ENGAGE RESEARCH
ACTIVE INSTITUTIONS, THERE'S
PROBABLY MORE.
OF COURSE IF YOU HAVE
SUGGESTIONS WE'RE OPEN TO THAT
SO FEEL FREE TO E-MAIL ME,
FRANCESCA, TINA, ROBIN, WE'LL
GET IT ON THE AGENDA.
THANK YOU FOR YOUR INPUT.
YOU COME PREPARED, ESPECIALLY
DISCUSSANTS ON THE TOPICS COME
PREPARED FOR DISCUSSIONS,
APPRECIATE YOUR THOROUGH
REVIEWS.
ONE MORE THING BEFORE WE SIGN
OFF, REMINDER, WE HAVE THE NEXT
COUNCIL OF COUNCILS MEETING,
WHICH IS SCHEDULED FOR SEPTEMBER
12-13, THAT IS GOING TO BE IN
PERSON.
AS MENTIONED BEFORE.
WE'RE EXCITED ABOUT MEETING YOU
IN PERSON.
I HAD THE OPPORTUNITY TO MEET
JENNIFER LAST WEEK AT THE NIA
COUNCIL MEETING, LOOKING FORWARD
TO GETTING THAT THIRD DIMENSION.
SO WITH THAT, MORE TO COME FOR
SEPTEMBER.
HAVE A WONDERFUL SUMMER.
WE'LL SEE YOU ALL AS WE APPROACH
FALL.
WITH THAT, WE'RE ADJOURNED.
THANK YOU, EVERYONE.
[END OF PROGRAM]
...
>> OKAY.
GOOD MORNING, EVERYONE.
THIS IS THE ONE-DAY MEETING OF
THE NIH COUNCIL OF COUNCILS, NOW
IN SESSION, IN PUBLIC SESSION
SHOWN LIVE TO ANYONE WHO WISHES
TO TUNE IN.
I'M TARA SCHWETZ, NIH DEPUTY
DIRECTOR FOR DPCPSI, REALLY GLAD
TO BE HERE WITH YOU ALL AGAIN
FOR THE COUNCIL MEMBERS TODAY.
I'M JOINED HERE IN THE ROOM BY
DR. FRANZISKA GRIEDER AND
ADDITIONAL COLLEAGUES HERE WITH
ME INCLUDING THE DPCPSI DEPUTY
DIRECTOR, SENIOR ADVISER AND
PROGRAM ANALYST WHO HELPS
COORDINATE COUNCIL OF COUNCILS,
SO I WANT TO THANK THE COUNCIL
MEETING PLANNING TEAM MEMBERS
FOR ALL OF THEIR WORK AND
SUPPORT OF ALL THE COUNCIL
ACTIVITIES AS THESE THINGS, YOU
KNOW, GENERALLY GO PRETTY
SMOOTHLY.
BUT IT TAKES A LOT OF TIME AND
PLANNING TO MAKE THAT HAPPEN.
BEFORE WE REALLY KICK IN TO FULL
GEAR ON FULL OPEN SESSION HERE,
I'M GOING TO TURN IT TO
FRANZESKA FOR PROCEDURES BEFORE
ROLL CALL.
>> GOOD MORNING TO EVERYBODY.
I WILL RUN THROUGH SOME RULES
WHICH WILL HELP ENSURE EVERYBODY
IS ABLE TO CONTRIBUTE.
WE ASK THAT YOU REMAIN MUTED
WHEN YOU'RE NOT SPEAKING,
ACTIVELY SPEAKING.
PLEASE NOTE THE HOST.
>> GOOD MORNING, EVERYONE.
THIS VIRTUAL ONE-DAY MEETING OF
THE COUNCIL OF COUNCILS IS NOW
IN SESSION.
IN PUBLIC SESSION, IT'S BEING
SHOWN LIVE TO ANYONE WHO WISHES
TO WATCH AND TUNE IN.
SO I'M TARA SCHWETZ, NIH DEPUTY
DIRECTOR FOR PROGRAM
COORDINATION, PLANNING,
STRATEGIC INITIATIVES, AND
REALLY GLAD TO BE HERE WITH YOU
ALL AGAIN FOR THE COUNCIL
MEMBERS TODAY.
I'M JOINED HERE IN THE ROOM BY
DR. FRANCESCA GRIEDER, EXECUTIVE
SECRETARY OF THE COUNCIL OF
COUNCILS, AS WELL AS A NUMBER OF
ADDITIONAL COLLEAGUES HERE WITH
ME INCLUDING THE DPCPSI DEPUTY
DIRECTOR ROBIN KOWOZOI, SENIOR
ADVISER AND A PROGRAM ANALYST.
I WANT TO THANK THE COUNCIL
MEETING PLANNING TEAM MEMBERS
FOR ALL OF THEIR WORK IN SUPPORT
OF ALL THE COUNCIL ACTIVITIES AS
THESE THINGS, YOU KNOW,
GENERALLY GO PRETTY SMOOTHLY BUT
IT TAKES A LOT OF TIME AND
PLANNING TO MAKE THAT HAPPEN.
BEFORE WE REALLY KICK IN TO FULL
GEAR ON FULL OPEN SESSION HERE,
I'M GOING TO TURN IT OVER TO
FRANKCESKA FOR PROCEDURES BEFORE
WE GET GOING.
>> THANK YOU, TARA.
GOOD MORNING, EVERYBODY.
I WILL RUN THROUGH SOME RULES
WHICH WILL HELP ENSURE THAT
EVERYBODY IS ABLE TO CONTRIBUTE.
WE ASK THAT YOU REMAIN MUTED
WHEN YOU'RE NOT SPEAKING,
ACTIVELY SPEAKING.
PLEASE NOTE THAT THE HOST