I HAVE A REQUEST.
YOU'RE OUR ADVISORY BOARD.
YOU ARE THE ONES WHO LOOK AT
WE'RE DOING, WE WANT YOU TO
CHALLENGE US TO BE BRAVE AND
BOLD, OKAY?
WE'RE THE TEAM.
HEADS DOWN THINKING ABOUT NIH.
YOU'RE THE PERSPECTIVE OF A
DIVERSE OUTSIDE WORLD.
SO CHALLENGE US TO BE BRAVE AND
BOLD.
THAT'S WHY WE NEEDS YOU HERE,
JUST REMINDING YOU OF THAT.
THANKS FOR BEING HERE.
ANY OTHER COMMENTS?
ALL RIGHT.
FIRST PRESENTATION TODAY IS
ABOUT THE HeLa GENOME ACCESS
WORKING GROUP AND DATA ACCESS
REQUESTS.
GARTH GRAHAM, DIRECTOR AND
GLOBAL HEAD OF HEALTH CARE AND
PUBLIC HEALTH CARE AT GOOGLE AND
YouTube, AND LYRIC
JORGENSON.
AS OF YESTERDAY, SHE'S
OFFICIALLY THE PERSON HERE, NOT
ACTING.
>> I'LL GET STARTED.
CONGRATULATIONS, LYRIC.
I'M GARTH GRAHAM, SERVING
ALONGSIDE LYRIC TO CO-CHAIR THE
HeLa GENOME DATA ACCESS
WORKING GROUP.
WE'RE GOING TO TALK YOU THROUGH
ONE OF THE PROPOSALS AND OUR
OVERALL BROADER PLAN AS WE
REENERGIZE OUR EFFORTS.
NEXT SLIDE PLEASE.
TODAY WE'LL BE REPORTING ON
WORKING GROUP EVALUATION OF A
RESEARCH PROPOSAL TO ACCESS
HeLa CELL LINE GENOMIC DATA
AS THE WORKING GROUP DISCUSSING
AS WELL NIH EFFORTS TO
R EINVIGORATE THE LACKS FAMILY
AGREEMENT.
THE AGREEMENT HAS EXPECTATIONS
FOR INVESTIGATORS WANTING TO
ACCESS.
TO ABIDE BY TERMS SET FORTH IN
THE USE AGREEMENT, SO THESE
TERMS INCLUDE USING THE DATA FOR
SPECIFIC PURPOSES, DISCLOSING
WHETHER RESEARCH COULD RESULT IN
A PATENT, ACKNOWLEDGING THE
LACKS FAMILY FOR THEIR
CONTRIBUTIONS AND TO DEPOSIT ANY
FUTURE WHOLE GENOME SEQUENCE
DATA GENERATED FROM HeLa
CELLS INTO THE DATABASE OF
GENOTYPES AND PHENOTYPES.
NEXT SLIDE PLEASE.
THIS IS CURRENT ROSTER OF FOLKS
WHO ARE WORKING ON THE HeLa
WORKING GROUP.
AND THAT WORK IS COORDINATED BY
EXECUTIVE SECRETARY, DOING AN
AMAZING JOB.
WE'RE GRATEFUL TO HAVE HENRIETTA
LACKS'S GRAND GRANDSON,
GRANDDAUGHTER, AND GREAT
GRANDDAUGHTER AS PART OF THE
WORKING GROUP.
AS A REMINDER HERE ARE THE
CRITERIA WHEN WE'RE EVALUATING
ACCESS REQUEST.
SO THE HeLa DATA USE
AGREEMENT ADVISES INVESTIGATORS
TO ADDRESS THESE.
IN ADDITION TO DESCRIBING THE
OBJECTIVES OF THE RESEARCH
PROJECT, THE DESIGN AND
ANALYSIS, THEY ARE PROVIDING A
STATEMENT EXPLAINING WHY THE
HeLa CELLS GENOME SEQUENCE
DATA IS VALUABLE AND ESSENTIAL
FOR THE PROPOSED RESEARCH.
PLANS FOR THINGS LIKE IP OR
COMMERCIALIZATION OF A PRODUCT
OR SERVICE IS NOT USED BY THE
WORKING GROUP TO MAKE AN
EVALUATION, THIS INFORMATION IS
OBTAINED FOR DISCLOSURE PURPOSES
ONLY.
THE EVALUATION DOESN'T INCLUDE
ACTUAL EVALUATION OF THE
SCIENTIFIC MERIT.
THIS GIVES A SNAPSHOT OF
STATISTICIAN OF REQUEST
EVALUATED AND APPROVED BY NIH
DIRECTOR.
THERE ARE INSTANCES WHEN
REQUESTS HAVE BEEN DISAPPROVED,
AND WILL BE DISAPPROVED IF THEY
DO NOT MEET SPECIFIC
EXPECTATIONS DESCRIBED IN THE
HeLa DATA USE AGREEMENT.
NEXT I'LL BE REPORTING ON THE
EVALUATION OF ONE SPECIFIC
REQUEST TO THE ACD.
NEXT SLIDE PLEASE.
THIS REQUEST IS FROM THE
WEISSMAN INSTITUTE IN ISRAEL,
DOUBLE CUTS IN THE GENOME USING
A SPECIFIC DNA-CUTTING
TECHNOLOGY CRISPR/CAS9, AND TO
MAKE THE CUTS INVESTIGATOR NEEDS
TO DESIGN HeLa-SPECIFIC
SINGLE GUIDE RNA OR NUCLEIC
ASSAY GUIDES TO DIRECT WHERE THE
CUTS ARE MADE IN THE HeLa
CELL GENOME.
SO ACCESS TO THE HeLa CELL
GENOME SEQUENCING STUDIES WOULD
ALLOW THESE INVESTIGATORS
THROUGH THE DEVELOPED HeLa
SPECIFIC SINGLE GUIDE RNA.
THE WORKING GROUP FORMED THE
REQUEST TO BE CONSISTENT WITH
THE HeLa DATA USE AGREEMENT.
AND NOW WE TURN IT OVER TO THE
ACD FOR ANY DISCUSSION, ANY
QUESTIONS, OR ANY CONCERNS
REGARDING THIS PARTICULAR
PROPOSAL BEFORE WE GO INTO THE
SESSION.
>> OPEN FOR DISCUSSION.
QUESTIONS, CONCERNS?
>> THIS IS GISELLE.
THANK YOU, GARTH, FOR THAT
PRESENTATION.
I DON'T HAVE A SPECIFIC QUESTION
ABOUT THIS STUDY BUT I DO HAVE A
GENERAL QUESTION ABOUT HOW THE
ADVISORY -- THE WORKING GROUP
ASSESSES THERE WHETHER THERE'S
INTELLECTUAL PROPERTY OR
POTENTIAL ROYALTY FOR
COMMERCIALIZATION OPPORTUNITIES
AND HOW THAT IS ASSESSED AND
WHAT SORTS OF GUIDANCE
REGULATIONS EXIST AROUND THE
COMMERCIALIZATION, FUTURE -- THE
USE OF CELLS THAT COULD LEAD TO
COMMERCIALIZED PRODUCTS.
>> LYRIC, COULD YOU SPEAK TO
THAT PLEASE?
>> SURE, HAPPY TO DO SO.
IN TERMS OF REVIEW, WE ASK THE
SUBMITTERS TO PUT INTO THEIR
PROPOSAL A PLAN OR THEIR
EXPECTATIONS, WE DO NOT REALLY
LOOK THROUGH THE DOWNSTREAM.
HOWEVER, IF PLANS CHANGE AT ANY
TIME THEY ARE ASKED TO COME BACK
TO LET US KNOW SO WE CAN HAVE A
DISCUSSION BEFORE ANY COMMERCIAL
ACTIVITY HAPPENS.
>> I'M JUST WONDERING IF WE HAVE
AN OBLIGATION GIVEN THE HISTORY
OF THE INTERACTION BETWEEN THE
LACKS FAMILY AND OUR SCIENTIFIC
ENTERPRISE.
WHAT I PUT ON THE TABLE,
OBVIOUSLY CAN'T BE ADDRESSED
TODAY, BUT WHAT ARE CONTINUED
OBLIGATIONS BEYOND JUST
UNDERSTANDING AND APPROVING A
STUDY MOVING FORWARD, WHEN
THERE'S OPPORTUNITY FOR THOSE
PROCEEDS TO BE USED IN A WAY
THAT IT CONTINUES THE SPIRIT OF
THE LACKS FAMILY INVOLVEMENT IN
THIS SCIENTIFIC ENTERPRISE AND
ALSO ADDRESSES SOME THINGS WE
TALKED ABOUT YESTERDAY AROUND
ENGENDERING TRUST WITH
PARTICULARLY IN COMMUNITIES THAT
HAVE BEEN HARMED BY OUR
SCIENTIFIC ENTERPRISE.
>> SO, AGAIN, I THINK NIH HAS
ENTERED INTO THIS AGREEMENT FOR
THIS EXACT PURPOSE.
AND AS REFLECTED BY THE
INCLUSION OF THREE MEMBERS OF
THE LACKS FAMILY, WHO ARE VERY
GRACIOUS IN DONATING THEIR TIME
AND ENERGIES TO THIS, AND I CAN
TELL YOU THE REVIEWS ARE TAKEN
VERY SERIOUSLY, NOT ONLY BY THEM
BUT BY ALL MEMBERS.
AND SO WE DO REQUEST THAT
INFORMATION UP FRONT.
IF PLANS CHANGE INVESTIGATORS
AREN'T EXPECTED TO COME BACK TO
US, I DON'T KNOW, LYRIC, IF YOU
COULD ADD MORE.
>> EXCELLENT POINT, EXCELLENT
QUESTION.
YOU DO HEAR PRIVATE FOUNDATIONS
DONATING PROCEEDS TO THE LACKS
FOUNDATION OR OTHERS TO GENERATE
ROYALTIES BACK TO THE FAMILY OR
AT LEASE THOSE EFFORTS.
HERE, GIVEN WE'RE TALKING ABOUT
THE HeLa CELLS, SO YOUR
UBIQUITOUSLY USED, THE FAMILY
MEMBERS ARE INTERESTED IN MAKING
SURE SCIENCE CAN PROCEED AND ARE
EXCITED TO HAVE THIS HONORING
LEGACY FOR THEIR GRANDMOTHER AND
AS PART OF THAT THEY HAVE BEEN
MAKING SURE THEY ARE USED TO
ADVANCE SCIENCE AND PEOPLE
UNDERSTAND CONTRIBUTIONS AS WELL
AS HONORING OF THEIR PRIVACY AND
CHOICES HOW THEY WANT THE CELLS
USED.
THAT'S WHERE THIS COMES INTO
PLAY, TO BROKER WHAT ARE THE
FAMILY'S PREFERENCES INSTEAD OF
ASSUMPTIONS WHAT WE THINK.
WE'LL TALK A FEW MINUTES AFTER
THE VOTE WHAT WE'RE DOING TO
CONTINUE TO HONOR, UPHOLD THAT
AGREEMENT WE MADE.
>> YOUR COMMENTS THIS MORNING
ARE EXACTLY WHY WE BRING IT TO
THE ACD IN AN OPEN MEETING, AS A
SECOND LAYER, SO THANK YOU FOR
RAISING THIS AND THAT'S WHY
WE'LL CONTINUE TO BRING THESE
THINGS BACK TO THE ACD AS AN
ADDITIONAL CHECK.
I'M SORRY, GARTH.
>> IN OUR WORKING GROUP
DISCUSSIONS WHERE WE HAVE THE
FAMILY PRESENT, YOU KNOW, WE DO
QUESTION AND HAVE A LOT OF THESE
DISCUSSIONS SO I THINK IT'S
IMPORTANT TO KNOW THAT THE
WORKING GROUP IS ACTIVE IN
EVALUATING AND THINKING THROUGH
THESE DYNAMIC AND CERTAINLY AS
LYRIC POINTED OUT, YOU KNOW, WE
RELY ON THE FOLKS WHO ARE THE
APPLICANTS TO DISCLOSE ANY
CHANGES OR ANY UPDATES AS THEY
MOVE ALONG IN THE PROCESS.
>> I HAD THE OPPORTUNITY TO MEET
THE LACKS FAMILY WHEN DOING WORK
AT NHGRI A DECADE OR MORE AGO.
I'M ASSUMING THAT CONFERENCE OR
WORKING GROUP AT THAT POINT LED
TO THIS PARTICULAR WORKING
GROUP.
I DON'T KNOW HOW LONG THIS
WORKING GROUP HAS BEEN IN
EXISTENCE BUT THESE
CONVERSATIONS, I THINK THE
WILLINGNESS TO HAVE THESE
CONVERSATIONS, THE WILLINGNESS
TO CONTINUE TO RECOGNIZE THE
OBLIGATIONS THAT WE HAVE TO --
AND THIS PARTICULAR INSTANCE WE
HAVE THE GIFT OF ACTUALLY BEING
ABLE TO UNDERSTAND THE
PROVENANCE OF THESE CELLS AND
THEIR FAMILIES.
BUT THERE ARE OTHER TIMES AND
PLACES WHETHER WE HAVE DATA
CONTROLS, ALL KINDS OF OTHER
INFORMATION FROM FAMILIES THAT
ARE IN COMMUNITIES THAT ARE
UNDERSERVED, SO I PUT THIS ON
THE TABLE JUST FOR US TO KEEP IN
MIND THAT THERE'S STILL
CONTINUED OPPORTUNITIES FOR US
TO MEET THOSE OBLIGATIONS.
PEOPLE ARE INTERESTED IN HOW
WE'RE STEPPING UP.
>> ONE THING I'LL SAY ABOUT THIS
MODEL, BEING PART OF IT, IT'S
REFRESHING TO HAVE, YOU KNOW,
BOTH NIH, YOU KNOW, OUTSIDE
SCIENTISTS, THE FAMILY, ALL OF
THE INGREDIENTS TOGETHER, WHEN
EVALUATING AND THINKING ABOUT
STEPS MOVING FORWARD.
I DO THINK IT SERVES AS A GOOD
TEMPLATE FOR HOW WE THINK ABOUT
ADVANCING COMMUNITY TRUST AND
ENGAGEMENT AS WE DO EFFORTS.
>> THAT'S AN EXCELLENT SEGUE TO
THE SECOND HALF OF THE
PRESENTATION.
BEFORE THAT I WANT TO MAKE SURE
THAT WE TAKE A VOTE.
>> YEAH.
>> OKAY.
>> WE HAVE A COMMENT FIRST.
>> YES.
I WANT TO ACTUALLY MAKE A POINT
ABOUT THE SCIENTIFIC VALUE OF
THE PROPOSED RESEARCH.
ACTUALLY, THE CRISPR/Cas IS
POWERFUL TECHNOLOGY BUT EXISTING
LIBRARIES ARE DESIGNED AGAINST
REFERENCE GENOME, DOMINATED BY
EUROPEAN ANCESTRY, SO WHEN THEY
APPLY TO CELLS FROM OTHER
GENOMES THEY EITHER DON'T WORK
OR HAVE OFF-TARGET EFFECTS.
DIRECTLY STUDYING AFRICAN
AMERICAN ANCESTRY GENOME WOULD
BE VERY HELPFUL.
>> WONDERFUL.
THANK YOU FOR THAT.
OKAY.
LET'S SEE.
EASIEST WAY TO TAKE A VOTE HERE
WOULD BE HOW MANY MEMBERS DO WE
HAVE ON THE VIDEO, LARRY?
>> WE HAVE GISELLE AND WE HAVE
GARTH.
AND WE LUCILLE.
WE'LL TAKE IT FROM EVERYBODY.
>> OKAY.
LET'S SEE.
LET'S DO BY SHOW OF HANDS.
THE PROPOSE ALTO ACCEPT THIS
RECOMMENDATION FROM THE WORKING
GROUP, THAT'S THE MOTION ON THE
AVAILABLE.
DO I HEAR A SECOND FOR THAT?
OKAY, SECOND.
FINAL QUESTIONS?
NO?
ALL RIGHT.
ALL IN FAVOR RAISE YOUR HAND.
OKAY.
THANK YOU.
ANY OPPOSED?
AND NOBODY ABSTAINING?
OKAY.
THANK YOU.
AND THANK YOU TO THE WORKING
GROUP FOR BRINGING THIS FORWARD
AND GISELLE, THANK YOU FOR YOUR
SPECIFIC COMMENTS, AND GARTH,
FOR THIS ILLUSTRATION OF WHAT WE
LOPE IS A POSITIVE TRANSPARENT
AND HOPEFULLY TRUST-BUILDING
EXERCISE, EXAMPLE FOR HOW WE
OUGHT TO BE DOING MORE OF THIS
KIND OF WORK.
THANK YOU.
OKAY.
NEXT, LYRIC, GO AHEAD.
>> THERE WE GO.
I'M SO GRATEFUL FOR -- SORRY,
THERE WE GO.
GISELLE AND HOWARD'S COMMENTS
WHO SET THIS NEXT PORTION UP,
PERFECTLY.
WE ARE AT THE 10-YEAR
ANNIVERSARY OF THE HISTORIC
AGREEMENT WITH THE LACKS FAMILY,
A GOOD TIME TO EVALUATE PROGRESS
MADE, REAFFIRM COMMITMENT UNDER
NEW LEADERSHIP, FIGURE OUT WAYS
TO STRENGTHEN AND USE THIS AS
EXAMPLE FOR OTHER PARTNERSHIPS
MOVING FORWARD.
IT HOLDS STRONG.
WE HAD A DIRECTORY'S
ANNOUNCEMENT IN CONJUNCTION
WITH THE LACKS FAMILY IN AUGUST
WHEN THE 10-YEAR ANNIVERSAR WAS
CELEBRATE AND IS ON ARE
EXTREMELY GRATEFUL FOR THE LACKS
FAMILY TO EDUCATE AND WORK WITH
US, SHOWING WHAT A REMARKABLE
FAMILY THEY ARE.
SO FOR THE ACD TODAY, THIS
10-YEAR ANNIVERSARY MARK HAS
PROVIDED US WITH THE OPPORTUNITY
TO ENTER A NEW PHASE,
REESTABLISH OUR COMMITMENT,
THINK ABOUT SOME ADDITIONAL
STEMS -- STEPS TO UPHOLD,
SHOWING TRENDS IN DATA OVER TEN
YEARS, TO HOWARD'S POINT, AND
WHAT WE'RE THINKING FOR NEXT
STEPS.
SO BEFORE I BEGIN I WANT TO
REMIND YOU AGAIN THE AGREEMENT
CAME IN 2013, GARTH WALKED
THROUGH THAT VERY NICELY SO I
WON'T REMIND YOU ABOUT ALL THE
REQUIREMENTS.
SINCE THE AGREEMENT WAS
ESTABLISHED IN 2013, NIH
RECEIVED 14 HeLa CELL
DATASETS FOR THE AGENCY TO
OVERSEE.
I WANT TO POINT OUT MANY OF THE
HeLa CELL DATASETS WE
RECEIVED ARE VOLUNTARY
SUBMISSIONS, NOT NIH-FUNDED
INVESTIGATORS WHO RECOGNIZE THE
VALUE AND IMPORTANCE OF HONORING
THIS AGREEMENT AND HONORING OUR
COMMITMENT TO THE FAMILY FROM
AROUND THE WORLD.
THIS SHOWS IMPORTANT RECOGNITION
OF THE AGREEMENT IN THE
COMMUNITY.
IMPORTANTLY WE'VE SEEN SOME
REALLY IMPACTFUL RESEARCH
CONDUCTED USING THESE DATA.
EXCUSE ME.
SINCE 2013, THE DATA THAT HAVE
BEEN DEPOSITED HAVE BEEN USED IN
13 PUBLICATIONS REPORTED TO NIH,
KEY HERE, RELIES ON BEING
REPORTED UNDER THE AGREEMENT
INCLUDES TEN PUBLICATIONS BY
DATA ACCESSORS REQUESTING THE
DAD AND THREE PUBLICATIONS BY
INVESTIGATORS WHO DEPOSITED THE
DATA.
IF YOU LOOK AT THE GRAPH ON THE
RIGHT, YOU SEE THE RELATIVE
CITATION RATIO.
I'M NOT GOING TO GET INTO
COMPLEXITIES BUT IN GENERAL A
METHOD NIH DEVELOPED FOR SHOWING
HOW PAPER CITATIONS COMPARE TO
OTHER PAPERS WITH CITATION
RATES.
IF YOU LOOK AT ONE BEING
AVERAGE, THESE PUBLICATIONS HAVE
REALLY BEEN GENERATED AT MUCH
HIGHER RATIOS.
YOU SEE SOME REALLY IMPACTFUL
ONES INCLUDING THIS 2013 PAPER
THAT'S BEEN CITED OVER 800
TIMES.
YOU'LL SEE WHILE 13 PUBLICATIONS
MIGHT SEEM LIKE A SMALL NUMBER
RELATIVE TO 90 APPROVED
REQUESTS, THIS NUMBER IS ROUGHLY
SIMILAR TO RATIO WE SEE IN THE
DATABASE OF GENOTYPES AND
PHENOTYPES, DBGaP, THE LARGEST
CONTROLLED DATA ACCESS
REPOSITORY.
NEXT THE REQUEST FOR DATA,
DESPITE THE VALUE THAT HOWARD
MENTIONED IN TERMS OF THE USE OF
THE CELL LINE AND THE
INCREASINGLY IMPACTFUL
PUBLICATIONS OVER TIME SINCE THE
AGREEMENT IN 2013 REQUESTS FOR
ACCESS TO THE DATA HAVE
DECLINED.
WE AT NIH WANT TO UNDERSTAND
WHAT WAS DRIVING THIS, WAS THERE
LESS VALUE IN USE OF THE CELLS
OR WAS THERE LESS AWARENESS OR
HOW CAN WE REALLY UNPACK THIS?
SO, LOOKING THROUGH THE DECLINE
WE LOOKED AT PUBLICATIONS, USING
OUR GENERATING HeLa CELL
DATA OVER A 3-YEAR PERIOD, THAT
REPORTED NIH FUNDING.
SO USING OR GENERATING HeLa
CELL DATA WITH NIH FUNDING.
AS SHOWN HERE WE FOUND CONTINUED
GENERATION AND USE OF HeLa
CELL DATA THAT SHOULD PLAUSIBLY
HAVE BEEN UNDER THE AGREEMENT.
THIS IMPLIES THE CAUSE IN
DECLINING AWARENESS OF OUR
AGREEMENT FOR THE LACKS FAMILY
RESEARCH AGREEMENT IS THE
CULPRIT AND NOT DECLINING
INTEREST IN HeLa CELLS DATA.
SO, THESE DATA TO US SUGGEST
THERE'S AN OPPORTUNITY AND
IMPERATIVE TO INCREASE
AWARENESS.
THE USE IS CONTINUING, BUT THE
AMOUNT BEING REPORTED BACK TO
THE AGENCY SUGGESTS THEY ARE
GETTING ACCESS TO THESE CELLS IN
OTHER VENUES AND WE WANT TO DO
MORE TO PROMOTE THE HONORING OF
THE AGREEMENT.
SO, AS I MENTION IN AUGUST WE
COMMEMORATED THE 10-YEAR
AGREEMENT.
WE REAFFIRM OUR COMMITMENT
UPHOLDING THIS WORK AND DECIDED
TO TAKE STEPS TO REINVIGORATE
AGREEMENT WITH RESEARCH
COMMUNITIES, STEPS DISCUSSED
WITH THE ACD WORKING GROUP AND
OF COURSE THE FAMILY EAGER TO
CONTINUE TO BE INVOLVED TAKING
STEPS FORWARD.
SO, FIRST WE PLAN TO CONDUCT
ADDITIONAL OUTREACH AT
CONFERENCES, VENUES, YOU ALL
REMEMBER WHEN THE AGREEMENT WAS
FIRST LAUNCHED THIS WAS
ACCOMPANIED BY A VERY NOTABLE
BOOK, THE MOVIE PRODUCED BY
OPRAH, AND A SENSATIONAL SPLASH
THAT GENERATED A LOT OF
AWARENESS IN THE COMMUNITY.
WE WANT TO MAKE SURE WE'RE
KEEPING THAT DRUM BEAT IN THE
COMMUNITY SO THEY ARE AWARE OF
THE OBLIGATIONS.
SECOND, WE WILL BE UPDATING OUR
GUIDANCE AND RESOURCES TO REMIND
RESEARCHERS ABOUT THE AGREEMENT
AND MAKE IT EASIER TO HONOR IT
SUCH AS NEW SAMPLE DATA
MANAGEMENT SHARING PLAN TO HELP
GUIDE RESEARCHERS PLANNING TO
GENERATE HeLa CELL DATA TO
BE ABLE TO REALLY DO THIS
SEAMLESSLY WITH THE HONOR AND
INTENT OF CITATIONS.
LAST, RAISED FOR THE ACD, YOU'RE
THE SOUNDING BOARD.
WE WANTED TO RAISE DISCUSSION OF
POTENTIALLY RETURNING ACD
MEETINGS TO AD HOC BASIS FOR THE
PURPOSE OF REVIEWING REQUESTS TO
ASSURE LONG WAITING TIMES DO NOT
DISINCENTIVIZE.
REVIEW TWICE A YEAR CAN BE
PROBLEMATIC FOR RESEARCHERS TO
START PROCESSES AND WE'RE
PROVIDE THE OPPORTUNITY TO NOT
HAVE DELAYS FOR RESEARCHERS
MOVING FORE WARD.
I TURN IT OVER TO DR.
BERTAGNOLLI TO MODERATE.
>> YES, SIR -- OKAY, QUESTIONS
FROM THE COMMITTEE?
>> I HAVE A QUESTION OR COMMENT
ACTUALLY.
THANK YOU, LYRIC, FOR THOSE
DATA.
I THINK IT'S REALLY INSTRUCTIVE.
ONE OF THE THINGS I WONDERED, IS
THERE AN OPPORTUNITY SIMILAR TO
OUR CLINICAL TRIALS
REPOSITORIES,
clinicaltrials.gov, TO HAVE
KIND OF REQUIREMENT BY JOURNALS
OF THE REGISTRATION OR IN SOME
WAY HAVE THE STUDY -- THERE'S AN
ACKNOWLEDGMENT THAT IT'S BEEN
THROUGH THE APPROVAL PROCESS, SO
I COULD SEE, YOU KNOW, THE
INTERNATIONAL, YOU KNOW, JOURNAL
EDITORS ASSOCIATION, I THINK
THAT IS WHAT THE NAME IS, HAS AN
AGREEMENT THAT ANYTIME A PAPER
SUBMITTED THAT USES HeLa
CELLS THAT THERE'S -- THEY HAVE
TO HAVE SOME ATTESTATION THAT
THEY HAVE GONE THROUGH THE
WORKING GROUP.
I'M THINKING CARROTS AND STICKS.
>> EXCELLENT SUGGESTION.
THERE'S TEMPLATE LANGUAGE FOR
CITATION BUT THE ONUS IS ON THE
INVESTIGATOR.
I LIKE THE IDEA WORKING WITH THE
JOURNAL AND PUBLISHING
COMMUNITIES TO FIGURE OUT HOW TO
STRENGTHEN THAT.
>> YEAH, THIS DATA YOU SHOW
QUITE COMPELLING AND I GUESS
UNDERSTANDABLE, BIG RELIEF TO
EVERYONE, GREAT INTENTIONS WHEN
IT CAME OUT BUT YOU FORGET OVER
TIME, SEEMS LIKE AN HONOR'S LACK
OF AWARENESS.
MAYBE WE COULD SEND A LETTER TO
THE EDITORS, YOU KNOW, JUST
SAYING WE'VE NOTICED THIS, SO
CAN YOU HELP US RAISE ATTENTION
TO THIS ISSUE BECAUSE THAT'S
WHERE IT NEEDS TO HAPPEN, YOU
KNOW, THAT'S A REALLY GREAT
CONTROL GATE IS AT THE AT THE
TIME OF PUBLICATION.
>> I ALSO WONDER ABOUT SENDING A
LETTER TO THE AUTHORS, YOU KNOW,
REMINDING THEM.
ONE PAPER WAS OUT OF COMPLIANCE,
WORKING ON A SECOND ONE,
OPPORTUNITY TO REMIND THEM AND
THEY MAY SPREAD THE WORD THROUGH
THEIR LABS AND COLLEAGUES.
>> YEAH, PRESUMABLY THEY COULD,
YOU KNOW, PUT AN ADDENDUM TO THE
PUBLICATION OR SOMETHING, IF IT
WAS SIMPLY A FAILURE TO
REMEMBER.
>> AN ADDENDUM AND MAKE SURE
RESERVE IS SHARED, THE KEY PORN
PRINCIPLE, SOMETHING THE LACKS
FAMILY FEELS VERY STRONGLY
ABOUT.
IT'S NOT JUST -- IT'S ALSO ABOUT
MAKING SURE THIS RESOURCE IS
USED AS FULLY AS POSSIBLE.
>> IT IS.
BUT I DO WANT TO EMPHASIZE THAT
SHERRILL AND TEAM DO A GOOD JOB
OF MONITORING THE ECOSYSTEM.
THERE'S A LOT OF WORK OCCURRING
ON THE STAFFING OF THE WORKING
GROUP AS WELL TO SEE WHAT'S
HAPPENING.
>> OKAY.
LYRIC, ANYTHING ELSE?
>> SOUNDS LIKE THE ACD IS
SUPPORTIVE OF DOING WHAT WE CAN
HERE.
>> YEAH, GREAT, OKAY.
THANK YOU VERY MUCH FOR THIS.
IT'S BEEN A VERY PRODUCTIVE
CONVERSATION.
WE'VE GOT SOME GREAT IDEAS.
THANK YOU I THINK WE CAN MOVE
ON.
WE HAVE AN UPDATE FROM "ALL OF
US."
JOSH DENNY, CHIEF EXECUTIVE
OFFICER OF THE "ALL OF US"
INITIATIVE WILL BE PRESENTING.
>> GOOD MORNING.
IT'S A PLEASURE TO SPEAK WITH
YOU AND GIVE YOU AN UPDATE WITH
THIS PRAYER.
I WANT TO BEGIN BY REFLECTING
BACK THIS PROGRAM WAS PRESENTED
IN SEPTEMBER OF 2015, INITIAL
BLUEPRINTS FOR THE PROGRAM, AT
AN ACD MEETING.
AND THIS IS A PICTURE OF THE
FIRST PAGE OF THE PDF OF THAT
DOCUMENT THAT LAID OUT MANY OF
THE INITIAL PLANS AND YOU CAN
SEE THE ASPIRATIONAL COMMENTS,
AROUND JUST THE EXCITEMENT
AROUND THE FUTURE OF THE PROGRAM
AND POTENTIAL TO REALLY MAKE A
DIFFERENCE HERE.
THIS IS OUR MISSION STATEMENT,
ESTABLISHED EARLY IN THE PROGRAM
AND HAS REMAINED RELATIVELY
UNCHANGED AS WE'VE GONE THROUGH,
TWEAKED A FEW WORDS, BUT
UNDERLYING COMPONENT IS WHAT
WE'VE EXPANDED, ACCELERATE HELL
RESEARCH AND MEDICAL
BREAKTHROUGHS, STARTS WITH
NURTURING PARTNERSHIPS WITH AT
LEAST A MILLION PEOPLE,
POTENTIALLY FOR DECADES, A
LONG-TERM PROGRAM AND WE WANT TO
PARTNER WITH PARTICIPANTS AND
REFLECT DIVERSITY IN THE UNITED
STATES.
WE WANT TO DELIVER A LARGE RICH
BIOMEDICAL DATASET INTO AS MANY
RESEARCH HANDS
RESPONSIBLY IN A PROTECTED WAY
AS WE POSSIBLY CAN.
CATALYZE AN ECOSYSTEM, COMMUNITY
OF RESEARCHERS, AND FUNDERS IN
THIS PROS ET CETERA.
WE STARTED WITH A SET OF CORE
VALUES, I'M GOING TO DO
SOMETHING DIFFERENT TODAY,
ORGANIZE MY BY OUR CORE VALUES,
AS WE WALK THROUGH AND SHOW HOW
WE'RE TRYING TO DELIVER ON EACH
WITH OUR PARTICIPANTS.
FIRST, WHO WE'RE ENROLLING.
WE WANT PARTICIPATION OPEN TO
EVERYONE, DIVERSITY IS AT THE
HEART OF EVERYTHING.
WE'RE APPROACHING 750,000
PARTICIPANTS, PROBABLY EXCEEDED
THAT BY THE END OF THE YEAR.
YOU CAN SEE OVER 520,000 HAVE
DONATED BIOSPECIMENS.
WE REPRESENT ALL 50 STATES AND
MOST U.S. TERRITORIES AT THIS
TIME.
AND REALLY THROUGH COVID WE
DEVELOPED A LOT OF TECHNIQUES
BECAUSE WE HAD, TO REACH PEOPLE
IN PLACES WE COULDN'T REACH
BEFORE.
THE STATES WHETHER YOU SEE MORE
REPRESENTATION ARE STATES
WHETHER WE HAVE HEALTH CARE
PROVIDER ORGANIZATIONS THAT ARE
RECRUITING.
AND NOW WE CAN REACH ANYONE ANY
WHERE THROUGH FUNDING SALIVA
KITS, PARTNERSHIPS WITH QUEST,
WE CONTINUE TO EXPAND OUR REACH
THROUGH NEW HEALTH CARE PROVIDER
ORGANIZATIONS, BLOOD BANKS,
OTHER WAYS TO REACH PEOPLE WHERE
THEY ARE.
THIS GIVES A SENSE OF THE
DIVERSITY OF THE PARTICIPANTS
THAT WE HAVE ENROLLED.
WE 46% BY RACE AND ETHNICITY.
OTHER CATEGORIES OF
UNDERREPRESENTATION, WE'RE OVER
80% DIVERSE BY AT LEAST ONE UVR
MET METRIC.
SEXUAL AND GENDER, RULE,
EDUCATIONAL ATTAINMENT, INCOME,
MEASURES OF DIVERSITY IN THE
PROGRAM.
WE CONTINUE TO EXPAND THIS.
WE MODIFIED TO CAPTURE BASIC
INFORMATION ON DISABILITY.
IT'S LIVING AND BREATHING TO GET
NEW INFORMATION OVER TIME.
THE NEXT PART, TRANSPARENCY,
PARTNERING, THROUGH TRUST.
AND SO WHAT WE DO, THIS IS LIST
OF OUR AWARDEES.
YOU CAN SEE DIFFERENT PARTNERS,
IN THE MIDDLE OUR HEALTH CARE
PROVIDER ORGANIZATIONS ENROLLING
PARTICIPANTS, WE HAVE BIOBANK AT
MAYO, GENOME PARTNERS, DATA AND
RESEARCH CENTER, A NUMBER OF
PARTNERS THAT THROUGHOUT THE
HEALTH ECOSYSTEM AND MANY OF YOU
REPRESENT AND RECOGNIZE
FAMILIAR NAMES.
ENGAGEMENT IS WHETHER WE BEGAN
THIS PROGRAM.
WE DID 77 ENGAGEMENT STUDIOS, 17
CITIES, BEFORE WE TALKED TO A
SINGLE PARTICIPANT IN THE
PROGRAM TO TALK ABOUT HOW WE
BUILD THIS PROGRAM, CREATING
THIS NETWORK OF PARTNERS ACROSS
THE COUNTRY, SOME LOCAL, SOME
PARTNERED WITH LOCAL HEALTH CARE
PROVIDER ORGANIZATIONS, SOME
HAVE NATIONAL REACH, TO REALLY
GIVE US NOT JUST CONNECTIONS BUT
ADVICE.
AND HELP SIT ON THE PROGRAM AND
HELP US DESIGN A PROGRAM.
THIS GIVES US A SENSE OF THE
ECOSYSTEM, MANY PARTS OF THE
ECOSYSTEM, TO DRIVE RESEARCH
FORWARD.
US ON ON A -- USING A PICTURE
OF AMBASSADORS, A ROTATING
SERVICE THESE PEOPLE DO.
AND TODAY WE HAVE 35 PARTICIPANT
AM AMBASSADORS AND 10
PARTICIPANT PARTNERS, THEY HELP
US TEST, PROVIDE INFORMATION
MODULES, ENGAGE IN THE PROGRAM.
WE'VE MEASURED THE INFLUENCE AND
OPINIONS OF OUR STEERING
COMMITTEE AND EXECUTIVE
COMMITTEE MEMBERS WHICH ARE A
LOT OF THEM ARE PARTICIPANT
PARTNERS BUT ALSO, YOU KNOW,
TRADITIONAL ACADEMICS, AND WITH
THEIR OPINIONS ARE AND WE SEE
INCREASE IN UNDERSTANDING,
DEEPENING OF PARTNERSHIPS WITH
THAT OVER TIME, WHICH IS WHAT
YOU WANT TO SEE.
ONE OF THE THINGS THAT'S BEEN AN
IMPORTANT PART OF THE ENGAGEMENT
EFFORTS IS TRIBAL EFFORTS.
WE SPENT A LOT OF TIME ON THIS,
REALLY OVER THE LAST YEAR.
BUT WE STARTED IN 2017 WITH
FORMING A TRIBAL COLLABORATION
WORKING GROUP WITH A NUMBER OF
INDIGENOUS MEMBERS IN
REPRESENTATION AND CO-CHAIRING,
LISTENING CENTERS THROUGH 2019
WITH REPORT ISSUED IN 2020.
WE IN MAY OF 2022 STARTED
ANOTHER PART WHERE WE ANNOUNCED
FUNDING ANNOUNCEMENT THAT
ALLOWED TRIBAL PARTICIPANTS TO
HELP US THINK ABOUT HOW WE
ENGAGE PARTICIPANTS AND
RESEARCHERS, THEN IN 2023 WE
ESTABLISHED A COULD
CONSULTATION TOPICS, SINCE WE
LAST TALKED ABOUT RESEARCH,
BEFORE COVID, IT WAS IMPORTANT
FOR US TO REENGAGE OUR TRIBAL
COMMUNITIES THROUGH CONSULTATION
AND LISTENING SESSIONS, TALKING
AGAIN ABOUT WHAT IT WOULD BE
LIKE TO DO RESEARCH ON THE
WORKBENCH.
RIGHT NOW THOSE DATA WERE HELD
OUT FROM THE RESEARCH WORKBENCH,
WE WANTED TO REENGAGE TRIBAL
COMMUNITIES.
WE ALSO WANTED TO TALK ABOUT
OTHER TOPICS, AND SET THE STAGE
FOR A LONG-TERM EVOLVING AND
CONTINUED ENGAGEMENT WITH OUR
TRIBAL COMMUNITIES.
AND SO WE FINISHED THAT
CONSULTATION IN SEPTEMBER, WITH
WRITTEN REPORTS, COMING IN
TOWARDS THE END OF OCTOBER, AND
WE'RE LOOKING FORWARD TO
CONTINUING THAT, ISSUING FINAL
REPORT IN 2024.
NOW TALKING ABOUT PARTICIPANTS
HAVING ACCESS TO THEIR
INFORMATION.
THIS IS A CORE VALUE OF THE
PROGRAM.
IT HAS BECOME A MUCH MORE COMMON
CALL, EVEN PROGRAMS LIKE MILLION
VETERANS PROGRAM NOT DESIGNED TO
RETURN INFORMATION, NOW TALKING
ABOUT RETURNING INFORMATION,
FROM THE BEGINNING PART OF OUR
CORE OF WHAT WE WANTED TO DO.
REGARDLESS OF HOW PEOPLE ENROLL.
THEY CAN ENROLL THROUGH A
SMARTPHONE APP, WEBSITE, HEALTH
CARE PROVIDER ORGANIZATION AND
MEET A PERSON WHO IS THEIR FIRST
INTRODUCTION TO THE PROGRAM.
REGARDLESS, PEOPLE CONTRIBUTE
THE SAME TYPES OF INFORMATION
AND SAME PROCESS OF CONSENT,
INCLUDING VIDEO, A DOCUMENT, AND
GET E-MAILED TO THEM.
AND THERE ARE A SET OF SURVEYS,
THROUGH OUR WEBSITE AND
SMARTPHONE APPS, IN PERSON
PERSONAL COLLECTIONS,
BIOSAMPLES, THEY CAN SHARE
FITBIT OR OTHER DIGITAL HEALTH
TECHNOLOGY DEVICES LINKED
THROUGH APPLE HEALTH KIT.
WE'VE BEEN GIVING OUT PILOTS OF
DEVICES, THROUGH PILOT PROGRAMS,
GIVING OUT DEVICES THAT THEY GET
TO CHOOSE BETWEEN FITBIT DEVICES
TO INCREASE THE NUMBER OF
PEOPLE, ESPECIALLY IN OUR
UNDERREPRESENTED BIOMEDICAL
COMMUNITIES, THAT HAVE DEVICES
THEY CAN SHARE WITH THE PROGRAM.
PEOPLE DO DECIDE TO PARTICIPATE
IN DIFFERENT WAYS.
NOT EVERYONE DOES DECIDE TO
SHARE A BIOSPECIMEN, THAT'S FINE
WITH US.
WE RECOGNIZE THERE ARE DIFFERENT
WAYS PEOPLE PARTICIPATE IN THE
PROGRAM.
AND WHEN WE TALK TO PARTICIPANTS
THROUGH OUR INITIAL ENGAGEMENT
STUDIOS, ONE OF THE THINGS WE
LEARNED WAS THAT ARE A VARIETY
OF WAYS PEOPLE WILL DERIVE
VALUE.
NOT JUST RETURN OF RESULTS BUT
RETURN OF VALUE.
WHAT IS VALUABLE TO YOU?
FOR MANY PEOPLE FIRST FOR THEM
IN VALUE WAS HOW WE CAN HELP
BENEFIT THEIR COMMUNITIES, HOW
WE ADVANCE RESEARCH, ALTRUISTIC
GOAL IS FOR THE BETTERMENT OF
SOCIETY AND HEALTH, HEALTH OF
THEIR POPULATIONS.
IN ADDITION IF YOU THINK ABOUT
THINGS WE CAN RETURN AND
COMMUNICATE THOSE RESULTES IN
THE RESEARCH WHAT ELSE CAN WE
GIVE BACK?
FIRST THING PEOPLE TOLD US THEY
WERE INTERESTED IN
HEALTH-RELATED GENETIC RESULTS.
YOU'LL SEE THAT PEOPLE ARE
ACTUALLY LOOKING AT ANCESTRY AND
TRAITS MORE THAN THE
HEALTH-RELATED INFORMATION WHICH
IS INTERESTING.
THEY ALSO WANT A VARIETY OF
OTHER THINGS BUT NOW WE'RE
AMONGST ALL THESE CATEGORIES OF
THINGS, THERE ARE WAYS WE ARE
RETURNING IT.
YOU CAN LOOK AT SURVEY DATA.
COMPARE IT.
IF YOU LINK IN THROUGH A
PARTICIPANT PORTAL, ELECTRONIC
HEALTH RECORD DATA THAT'S
VISUALIZED.
SOME PEOPLE LINKING TEN
PROVIDERS AND YOU CAN VISUALIZE
THAT IN ONE PLACE.
WE'RE LOOKING TO EXPAND THOSE
KINDS OF EFFORTS.
WE'RE COMMUNICATING SCIENTIFIC
FINDINGS AND TALKING ABOUT
OPPORTUNITIES TO BE INVOLVED IN
RESEARCH AS SELL.
THIS GOES INTO SOME OF OUR
GENETIC TRAITS, AND REPORTS THAT
WE'RE GIVING BACK.
HERE YOU CAN SEE WE STARTED WITH
GENETIC ANCESTRY AND TRAITS IN
2020, TOWARDS THE END OF THE
YEAR.
IT STARTS WITH CONTINENTAL AND
SUBCONTINENTAL ANCESTRY REPORTS,
FOR NON-HEALTH-RELATED TRAITS.
WHEN YOU LOOK AT HELP REPORTS AT
THE ENDS OF 2020 WE'VE JUST
CROSSED A YEAR OF RETURNING
THOSE RESULTS.
TWO CATEGORIES WE WENT THROUGH A
PROCESS WITH THE FDA,
INVESTIGATIONAL DEVICE EXEMPTION
TO DELIVER REPORTS TO OUR
PARTICIPANTS.
TWO CATEGORIES, HEREDITARY
DISEASE RISK REPORTS, CANCERS,
CARDIOMYOPATHY, FAMILIAL HYPO
LIPIDEMIA, MEDICINE, DNA,
PHARMACO GENOME IS, SEVEN JOINS
AND 50 MEDICATIONS RELEVANT IF
YOU HAVE ALTERED METABOLIZER
STATUS IN ONE OF THOSE SEVEN
GENES.
THIS SLIDE SHOWS THE -- WALKS
THROUGH FROM THE TOP THE NUMBER
OF PEOPLE THAT HAVE BEEN
NOTIFIED TO GET RESULTS, TO
CHOOSE RESULTS, RECEIVE RESULTS
HERE.
SO IF YOU LOOK AT THE SLIDE WE
STARTED THE ANCESTRY AND TRAITS
ABOUT TWO YEARS BEFORE WE WERE
ABLE TO DELIVER HEALTH-RELATED
RESULTS TO PARTICIPANTS.
SO IT'S BEEN OFFERED TO MORE
PEOPLE AND MORE PEOPLE HAVE SEEN
IT.
THE WAY THE PROGRAM WORKS, THE
WAY WE WORK THIS WITH THE FDA
AND IRB IS WE ACTUALLY INTERPRET
AND GENERATE OUR CLINICAL
RESULTS TO RETURN TO OUR
PARTICIPANTS FOR HEALTH-RELATED
AND PHARMACOGENOMICS WHEN THEY
SAY THEY WANT IT.
WHEN PEOPLE SAY THEY WANT IT,
THERE'S A PROCESS OF GENERATION,
INTERPRETATION OF PATHOGENIC
VARIANTS, VALIDATION IF IT'S ONE
OF THE ACMG 59, AND THEN RETURN
THOSE INFORMATIONS TO OUR
PARTICIPANTS.
AND SO YOU CAN SEE WE HAVE 60%
OF PEOPLE IN THAT MIDDLE ROW OF
COLUMNS IN SALMON AND ORANGE
THAT OPTED TO GET ANCESTRY AND
TRAITS OR NON-HEALTH-RELATED
TRAIT INFORMATION, AND ABOUT 50%
WOULD LIKE TO GET RESULTS FOR
HEREDITARY DISEASE RISK,
PHARMACOGENOMICS.
ONCE YOU TAKE INTO ONE OF THOSE
CATEGORIES MOST PEOPLE LOOK AT
BOTH.
SINGLE MOST VIEWED CONTENT IS
GENETIC ANCESTRY.
WE'RE SEEING A LOT OF PEOPLE SAY
WE WOULD LIKE MORE IN TERMS OF
GENETIC ANCESTRY ON THAT FRONT.
IN THE DISEASE RISK ELEMENTS AND
PHARMACOGENOMICS, WE'RE NOW
UPWARDS OF 75,000 PEOPLE THAT
RECEIVED THOSE RESULTS, OFFERING
TO 5,000 PEOPLE EACH WEEK AT
THIS POINT.
TO GIVE SOME CONTEXT OF THIS,
THAT WAS ONE OF THE PROJECTS I
HAD AT VANDERBILT WAS PART OF
THE EMERGE NETWORK, SENT FOUR
YEARS DOING THIS TO 4,000
PEOPLE.
EVERY WEEK WE DELIVER MORE
RESULTS BACK, OFFER MORE RESULTS
TO PEOPLE THAN WE DID IN FOUR
YEARS, WHICH WAS ACTUALLY A
LARGE SCALE EMERGE PROJECT AT
THE TIME.
WE'RE LOOKING FORWARD TO CLOSE
THOSE GAPS OF PEOPLE WHO WANT TO
GET THOSE RESULTS BACK, AND WE
INDUSTRIAL AVENUES TO CLOSE
TECHNOLOGICAL AS WELL AS WE
THINK ABOUT THINGS LIKE SALIVA
AND BLOOD BANK PARTICIPANTS AND
THINGS LIKE THAT.
SO THERE'S ONGOING DISCUSSION AS
WE REACH NEW PARTICIPANTS, NO
-- NEW WAYS WITH THE FDA IN THIS
PROCESS.
THIS GIVES SCREEN SHOTS OF
ANCESTRY AND TRAITS.
ON THE LEFT, YOU CAN SEE THE
CATEGORIES OF INFORMATION, YOU
CAN SEE SOME OF THE ANCESTRY
EXAMPLE REPORTS THERE.
THIS IS SOME INFORMATION ABOUT
WHAT IT LOOKS LIKE WE'RE SEEING
3% PATHOGENIC OR LIKELY
PATHOGENIC RATE IN THESE
CONDITIONS.
AT THIS POINT WE HAVE OVER 2200
PEOPLE FOR WHICH WE'VE
IDENTIFIED A PATHOGENIC OR
LIKELY PATHOGENIC VARIANT, REAL
DISEASE RISK IN THESE
PARTICIPANTS AND IT'S
ACTIONABLE.
ALL THESE, IF YOU'RE AWARE OF
THESE CONDITIONS, ARE THINGS FOR
WHICH THERE ARE RECOMMENDED
EITHER ENHANCED SCREENING OR
SOMETHING YOU CAN DO THAT
AMELIORATES THAT RISK.
PRIOR DATA WOULD SAY MOST OF
THESE PARTICIPANTS HAVE NO IDEA
THEY WOULD BE CARRYING THESE
VARIANTS.
AND YOU CAN SEE SOME OF WHAT THE
REPORT LOOKS LIKE.
FOR THESE RESULTS THEY ARE ALL
DELIVERED THROUGH GENETIC
COUNSELOR, AVAILABLE IN ENGLISH
AND SPANGLISH, WE SUPPORT
DIFFERENT LANGUAGES FOR REALTIME
TRANSLATION AND PEOPLE CAN GO
BACK HOWEVER MUCH THEY MIGHT
WANT TO TO ASK MORE QUESTIONS OR
IF THEY EVEN WANT TO ASK A
QUESTION BEFORE THEY WERE TO
DECIDE TO GET RESULTS BACK AND
WHAT IT MIGHT ENTAIL FOR THEM.
THIS LOOKS AT TWO OF THE SEVEN
JET STREAMS FOR PHARMACO
GENETICS.
I'VE HIGHLIGHTED THESE
POPULATIONS THAT WOULD HAVE POOR
METABOLIZER DECREASED FUNCTION
THAT WOULD HAVE RECOMMENDATIONS
FOR ALTERED PRESCRIBING FOR
DIFFERENT MEDICATIONS, ON THE
RIGHT MY RESULTS FOR TWO GENES
SO I HAVE ALTERED METABOLIZER
STATUS IN THESE AND WOULD HAVE
RECOMMENDATIONS FOR DIFFERENT
MEDICATIONS WERE I NEED TO BE
PRESCRIBED.
WHAT'S INTERESTING TO ME
PERSONALLY IN PART THIS IS TWO
OF THE GENE-DRUG INTERACTIONS
THAT I SPENT TIME MYSELF WORKING
ON, PUBLISHING ON, AND ONE OF
THESE VARIANTS WAS NOT ON THE
PLATFORM THAT WE INITIALLY
DEVELOPED AND IMPLEMENTED AT
VANDERBILT.
WE HAVE BROADER COVERAGE BECAUSE
WE'RE DOING SEQUENCING
INFORMATION AND WE CAN
CONTINUALLY UPDATE THESE OVER
TIME AND EVOLVE OVER TIME.
WE RELEASE ONE NEW SURVEY A
YEAR.
THIS WAS WHAT WE DID THIS YEAR,
FOCUSED ON MENTAL HEALTH AND
WELL-BEING.
WE HAVE A COUPLE, TWO SURVEYS
THAT GET INTO A LOT OF
CHALLENGING TOPICS.
IT DOES DEAL WITH THE TYPICAL
THINGS LIKE PHQ 9 OR GAD 7,
ANXIETY AND DEPRESSION RISK
FACTORS BUT GET INTO ADULT AND
CHILD TRAUMA, FAMILY DYNAMICS,
OTHER THINGS THAT YOU CAN SEE
AND GETTING AT TOPICS LIKE ADHD,
BIPOLAR AND OTHER CONDITIONS
ADDRESSED IN THE SURVEYS.
ONE THING WE'RE ABLE TO DO IN AN
ENGAGING WAY IS PROVIDE
ESSENTIALLY REALTIME IMMEDIATE
FEEDBACK ON PERSONALITY TRAITS
AGAIN MORE JUST ENGAGING, NOT
TELLING THEM NECESSARILY ABOUT
HEALTH BUT HOW CONSCIENTIOUS,
TESTED IN PROCESS OF
DEVELOPMENT.
IF THEY FOR INSTANCE ANSWER
CERTAIN QUESTIONS, INDICATOR
RISK FOR SEVERE DEPRESSION,
THERE IS A SCREENING AND THERE
ARE REFERENCES AND RESOURCE
PRESENTED TO PARTICIPANTS.
THIS WAS DEVELOPED WITH OUR
PARTICIPANTS, WITH OUR IRB OF
COURSE IN THE PROCESS.
NOW I'M GOING TO TALK ABOUT
RESEARCH A LITTLE BIT MORE HERE.
ACCESSING THESE DATA BROADLY FOR
RESEARCH PURPOSES.
MAINTAINING SECURITY AND
PRIVACY, HIGHEST IMPORTANCE.
AND THAT WE WILL GIVE HOPEFULLY
A CATALYST FOR POSITIVE CHANGE
IN RESEARCH.
WE HAVE DIFFERENT PHASES TO OUR
DATA THAT WE TRY TO MAKE
AVAILABLE AND HELP ENGAGE
RESEARCHER AUDIENCE, ONE OF
THESE IS OUR PUBLIC DATA BROWSER
SO PEOPLE CAN VIEW INFORMATION
ABOUT "ALL OF US" THROUGH THE
DATA BROWSER AND THERE'S NO
LOG-IN REQUIRED, IT'S ACCESSIBLE
ACROSS THE WORLD, IT'S HIGH
LEVEL AGGREGATE DATA THAT HELPS
YOU KNOW WHETHER OR NOT YOU CAN
START A RESEARCH PROJECT AND
WHETHER ENOUGH PEOPLE HAVE A
GIVEN CONDITION, WHETHER OR NOT
THEY MAY BE TAKING MEDICATION,
YOU CAN LOOK AT SURVEY
RESPONSES.
WE PROTECT PRIVACY.
WE FOUND THIS TO BE BE A
IMPORTANT TOOL AS THEY COME TO
MOBILE ENGAGEMENT UNITS OR
CONSIDER ENROLLMENT WE CAN SEE
PEOPLE THAT HAVE DISEASES LIKE
THEM AND THEY MAY BECOME MORE
ENGAGED IN JOINING THE PROCESS.
TO DO RESEARCHER ANALYSIS, TO DO
RESEARCH STUDIES YOU NEED TO
BECOME APPROVED RESEARCHER
THROUGH OUR RESEARCH WORKBENCH,
CLOUD BASED, AS YOU CAN SEE HERE
WE SUPPORT R AND PYTHON AND HAVE
A NUMBER OF GUI-BASED TOOLS TO
BUILD COHORT, BUILD DATASET,
EXPLORE.
WHEN IT COMES TO ANALYSIS IT'S R
AND PYTHON, SUPPORTED THROUGH
JUPYTER NOTEBOOKS, AND BETA
TESTING OF SASS AS A PLATFORM,
OUR STUDIO COMING ON TO GIVE
MORE VISUAL TOOLS, A NUMBER OF
EXAMPLE NOTEBOOKS THAT PEOPLE
CAN TAKE CODE PRE-MADE TO DO A
GENOME WIDE ASSOCIATION STUDY OR
HOW TO USE SURVEYS AND WE
CONTINUED TO DEVELOP THESE TO
HELP PEOPLE ACCELERATE THEIR
WORK, CURRENTLY OPEN TO ACADEMIC
HEALTH CARE AND NOT-FOR-PROFIT
ORGANIZATIONS.
AND ONE OF THE THINGS WE DO IS A
RESEARCHER THAT IS ONE OF THOSE
APPROVED ORGANIZATIONS CAN COME
ON FOR MANY OF THEM THEY HAVE
MASTER AGREEMENTS, SO THAT MEANS
A NEW RESEARCHER CAN START DOING
RESEARCH VERY RAPIDLY AFTER
GOING THROUGH THE HUMAN SUBJECTS
TRAINING AS PART OF OUR PROGRAM,
SPECIFIC TRAINING AROUND OUR
PROGRAM, STIGMATIZING RESEARCH,
CREATE WORKSPACE ON THE FLY
THROUGH A PASSPORT MODEL, THEY
ARE ABLE TO BE OVERSEEN BY
RESOURCE ACCESS BOARD.
IF THEY CLICK CERTAIN THINGS,
INDICATE THAT THIS COULD BE
POTENTIALLY STIGMATIZING IT'S
SOMETHING WE CAN LOOK AT.
THEY CAN START DOING RESEARCH IN
THE CLOUD, WE CAN LOOK AT
COMMUNICATE BACK IF WE NEED TO
WITH PARTICIPANTS, SO WE THINK
IT AC SELL RATES RE--
ACCELERATES RESEARCH AND
PROTECTION.
CURRENT DATASET RELEASED IN
APRIL, 400,000 WITH SURVEYS.
YOU CAN SEE DIFFERENT OTHER
METRICS.
BIG NEWS WAS MORE THAN DOUBLING
THE AMOUNT OF WHOLE GENOME DATA
AVAILABLE WITH 245,000 WHOLE
GENOMES.
WITH THOSE 245,000 WE'VE
OBSERVED A BILLION VARIANTS IN
THE DATASET, MORE THAN 100
MILLION OF THOSE VARIANTS OCCUR
IN THREE OR FOUR PARTICIPANTS,
AND ARE NOT IN NOMAD.
THESE ARE ESSENTIALLY VARIANTS
FOR WHICH THERE IS NOT EXTANT
DATA TO HELP DETERMINE WHAT
IMPACT IS.
IN OUR DATASET, UNLIKE OTHER
RESOURCES LIKE NOMAD WE HAVE
PHENOTYPES, SURVEYS,
QUESTIONNAIRES, THAT FIT THE
DATA.
WE CONTINUE TO GROW THE FIT BIT
DATA.
PEOPLE HAVE DONATED DATA
APPROACHING 100,000 PEOPLE THAT
WE'LL HAVE SOME SORT OF DIGITAL
HEALTH TECHNOLOGY AS WE PULL ALL
THESE TO GET DATA TOGETHER OVER
TIME.
WE RELEASED THE FIRST SET OF
LONG READ SEQUENCES OF A
THOUSAND PEOPLE OF AFRICAN
ANCESTRY.
ONE THING THAT WE SEE THAT ARE
NOVEL AND NOT IN OTHER RESOURCES
IS DIVERSITY BY GENETIC ANCESTRY
OF OUR PARTICIPANTS.
SO WHAT I SHOW HERE IS THE
COMPARISON OF THE GWAS DIVERSITY
MONITOR, BASICALLY IF YOU LOOK
AT ALL THE GWAS STUDIES
PUBLISHED TO DATE, WE CONTINUE
TO SEE THOSE GWAS STUDIES HAVE
BEEN RUNNING GREATER THAN 90% OF
EUROPEAN ANCESTRY.
SO WITH OUR DATASET
SIGNIFICANTLY MORE DIVERSE THAN
THAT, IN THE BLUE COMPARED TO
THE GRAY, YOU CAN SEE THAT I
THINK THAT'S HELPED DRIVING OF
UNDERSTANDING OF VARIATION,
DISCOVERY OF MORE VARIATION AND
SEEING VARIANTS INCREDIBLY RARE
IN EUROPEAN POPULATIONS, COMMON
IN OTHER ANCESTRIES, IMPORTANT
AS WE THINK ABOUT INTERPRETATION
OF GENETIC VARIANTS WHETHER THEY
ARE PATHOGENIC OR THINGS LIKE
THAT.
WE'VE BEEN BUILDING RESEARCHER
POPULATIONS WHEN WE FIRST
RELEASED IN 2020.
WE HAVE MORE THAN DOUBLED THE
NUMBER OF RESEARCHERS USING
OTHER PLATFORM THIS YEAR.
WE WERE RIGHT AT 3,000 WHEN THE
YEAR BEGAN SO WE HAVE SEEN
ACCELERATION, OVER 600
INSTITUTIONS, YOU CAN JUST AS
WE'VE ENGAGED DIVERSE
PARTICIPANTS IT'S IMPORTANT TO
ENGAGE DIVERSE RESEARCHERS.
WE THINK THAT'S IMPORTANT TO
GENERATE MORE HYPOTHESES, MORE
DIFFERENT KINDS OF STUDIES, AND
BETTER SCIENCE ULTIMATELY.
WE HAVE -- YOU CAN SEE 40
HBCUs, OVER 60
HISPANIC-SERVING INSTITUTIONS,
TRYING TO ENGAGE DIVERSE
RESEARCHER AUDIENCE, SOME AWARDS
ARE THINKING ABOUT THAT.
IN ADDITION TO TRADITIONAL
ACADEMIC ENVIRONMENTS WE HAVE
PARTICIPANT ADVOCACY GROUPS,
NATIONAL ALLIANCE FOR HISPANIC
HEALTH, ASIAN COALITION, WE
ENCOURAGE A DIVERSE BODY OF
RESEARCHERS TO COME IN.
THESE ARE SOME OF THE
PUBLICATIONS AND THEY ARE
ACCELERATING AS YOU WOULD
EXPECT.
YOU SEE A NUMBER OF PUBLICATIONS
AND REALLY ABOUT HALF THE
PUBLICATIONS THAT WE HAVE TOTAL
HAVE COME OUT THIS YEAR, AS YOU
MIGHT EXPECT WITH THE GROWTH OF
THIS.
SOME HIGHEST IMPACT PUBLICATIONS
HAVE BEEN AROUND SO FAR USE OF
FITBIT DATA ACROSS OVER KINDS OF
DATA, UPTICK IN HIGH PROFILE
JOURNALS.
I WANT TO GIVE AN EXAMPLE OF
GIVE OF DOING THIS PROJECT ON
THE WORKBENCH AS OPPOSED TO A
PRIOR LIFE OF PALESTINE.
THE FIRST GENOME WIDE
ASSOCIATION STUDY I WORKED ON
WAS PRIMARY HYPOTHYROIDISM.
IT TOOK US 2 1/2 YEARS, TEAMS AT
EACH SITE, DOING THINGS LINING
TYPING IN MISSPELLINGS OF
MEDICATION NAMES TO FIND THOSE
MEDICATIONS BECAUSE THEY WEREN'T
ALL CODED.
AND SO WE BUILT THESE ALGORITHMS
TO FIND THESE PARTICIPANTS,
THESE PATIENTS IN OUR RECORDS
THAT LOOKED LIKE THEY HAD
PRIMARY HYPOTHYROIDISM AND NOT
CANCER OR SECONDARY DISEASE,
THEN FOUND A SIGNAL IN
CHROMOSOME 9, YOU SEE TIME AND
COST OF THAT.
IN 2023, 2022 A POST BACK
JOINED MY OTHER LAB AND ACCESSED
THE WORKBENCH LIKE ANY OTHER
RESEARCHER WOULD IN "ALL OF US."
HE HAD NO SPECIFIC TRAINING IN
GENOMIC OR COMPUTATIONAL
GENETICS OR ELECTRONIC HEALTH
RECORD.
BUT IN ABOUT SIX WEEKS WAS ABLE
TO PRODUCE, REPRODUCE THAT
PHENOTYPE ALGORITHM USING THE
COHORT FOLDER, POINT AND CLICK,
ADAPTING THE CODE LEARNING WHAT
HE NEEDED TO DO.
I DIDN'T PUT HIM ON THE CLOCK.
IT JUST TOOK SIX WEEKS, MANY
MORE SIGNALS, IN THE 12 YEARS
SINCE THAT PUBLICATION WAS MADE
THERE HAS NOT BEEN A
SIGNIFICANTLY DIVERSE POPULATION
ENGAGED USING ASIAN AND EUROPEAN
AUDIENCES STUDY FOR
HYPOTHYROIDISM, NOTHING ELSE.
THIS IS THE FIRST MULTI-ANCESTRY
STUDIES WITH THIS CONDITION.
"ALL OF US" IS DESIGNED AS A
PLATFORM FOR NIH, EXPANDING
BEYOND THE NIH TO DO RESEARCH.
WE ARE DESIGNING OUR SELVES NOT
JUST OF COURSE TO ENGAGE
RESEARCHERS AS WE HAVE DONE TO
COME IN AND ALLS THE DATA BUT
HELP MAKE THE DATA RICHER.
THE DATA WE DELIVERED ALREADY IS
THE FOUNDATION, RESEARCHER
WORKBENCH, GENOME DATA,
ELECTRONIC HEALTH RECORD DATA,
SURVEY DATA WE'RE GETTING OUT
THERE.
WE WANT TO COLLABORATE WITH
OTHER INSTITUTES AND CENTERS AND
OFFERSES -- OFFICES TO BUILD ON
TOP OF THAT.
ON THE LEFT YOU SEE EXAMPLES.
WE DID A COVID SEROLOGY STUDY,
WE JUST LUNCHED EXPLORING THE
MIND, BEHAVIORAL QUANTITATIVE
BEHAVIORAL AND COGNITIVE TRAITS
PEOPLE ENGAGE WITH LIKE A BRAIN
GAMES PROCESS, THROUGH THE WORK,
THROUGH THE PORTAL.
AND THEN THE LARGEST OF THESE
WHAT WE CALL ANCILLARY STUDIES
IS A COLLABORATION OF 18
LAUNCHED IN THE SPRING.
THESE CAN BE RANGING FROM ALL
SORTS OF THINGS.
NPH HAS A COMPONENT OF
RANDOMIZED TRIAL WITH IT.
IT HAS OTHER COMPONENTS AS WELL.
AND SO NPH HAS THREE MODULES,
WE'VE LAUNCHED ALL OF THESE, AND
IT STARTED WITH THE FIRST
MODULE, 10,000 "ALL OF US"
PARTICIPANTS, ALL ENGAGED AND
EMBODIED WITHIN "ALL OF US."
TEN THOUSAND PARTICIPANTS THAT
WILL ANSWER SURVEYS, GIVE OTHER
BIOSPECIMENS, IN THE PROCESS,
AND OTHER PHYSIOLOGIC MEASURES.
A SUBSET OF THOSE IN MODULE 1
PARTICIPANTS WILL GO TO MODULE 2
INCLUDING SHORT-TERM DIETARY
INTERVENTIONS RANDOMIZED AND
OTHER MEASURES OF THE
BIOCHEMICAL AND PHYSIOLOGIC
CHANGES, AND SUBSET WILL GO TO
MODULE 3, DOMICILED CONTROLLED
FEEDING STUDIES.
AND THIS SHOWS THE GRAPH OF THE
LAUNCH IN GROWTH OF PARTICIPANTS
JOINING MODULE 1, WHEN I FIRST
LOOKED AT THIS I WAS WONDERING
WHY IT WAS PLATEAUING.
PEOPLE DON'T WANT TO START A
DIET STUDY BEFORE THANKSGIVING.
SO I THINK -- WE CAN SEE WE'RE
ON TARGET, HITTING OUR GOALS IN
TERMS OF GROWTH FOR NPH.
YOU CAN SEE THE INFORMATION NP
NPH IS BUILDING TO ADD THIS
INFORMATION INCLUDING MICROBIOME
DATA, METABOLOMIC DATA, AND
ENVIRONMENTAL COMPONENTS AS WELL
THAT WILL BE PART OF THIS AS
WELL AS DEVELOPING DIETARY
SURVEYS USING A.I. TO HELP THINK
ABOUT NEW WAYS WE CAN DO DIETARY
SUSTENANCE, UNDERSTAND WHAT
PEOPLE ARE EATING, AND SOME
MIGHT FIND ADOPTION ACROSS THE
LARGER "ALL OF US" PROGRAM AS
THEY GET DEVELOPED.
THIS ANNOUNCES RECENT FUNDING
WE'VE MADE, OVER THE LAST FEW
MONTHS.
IT STARTS WITH THE FIRST ONE
THERE, A NUMBER OF AWARDS THAT
WERE MADE IN PARTNERSHIP ACROSS
THE NIH, AGAIN THAT
COLLABORATION WITH OTHER
INSTITUTES AND STORIES AND
OFFERSES HAVE BEEN IMPORTANT.
27
27 SIGNED ON.
THE SECOND IS ENGAGEMENT AWARDS
FOR TRIBAL COMMUNITIES.
THESE ARE HELPING US DEVELOP --
ANNOUNCED IN AUGUST AND
SEPTEMBER ARE HELPING ESTABLISH
ADVICE AND GUIDANCE FOR HOW WE
GO TO ENGAGE TRIBAL COMMUNITIES
AND BUILD A DEEPER RELATIONSHIP
WITH THEM.
RIGHT NOW WE DO NOT ENROLL ON
TRIBAL LANDS IN ANY WAY, NOR
DIRECTLY ENGAGE, SOME
SELF-IDENTIFY PARTICIPATING
OFFER TRIBAL LANDS, OF COURSE,
AND THEN THE THIRD IS OUR CENTER
FOR LINKAGE AND ACQUISITION OF
DATA, CLAD AWARDS IN COLORADO.
SEEKS TO HELP US GATHER DATA
THAT WE CAN LINK IN,
ENVIRONMENTAL INFORMATION
EXCHANGE, NETWORKS TO PULL
TOGETHER.
LAST TWO SLIDES, PERSONALIZING
WHERE WE ARE AND TALK ABOUT THE
FUTURE.
MICHELLE ANDERSON IS ONE OF THE
FIRST PARTICIPANTS AMBASSADORS,
RN, ENGAGED IN THE SPACE AND
RECEIVED HER PHARMACOGENIC
INFORMATION AND JUST REALLY
TALKED ABOUT IN THIS STORY THE
IMPORTANCE OF THIS FOR HER TO BE
PART OF THE SOLUTION AND
ADVANCING SCIENCE AND, YOU KNOW,
THE LAST PART OF THE QUOTE HERE
HEALTH RESEARCH HASN'T ALWAYS
INCLUDED PEOPLE LIKE ME BUT ALL
OF US IS CHANGING THAT AND I'M
READY FOR IT, ECHOING WORDS OF
AMBASSADORS WHO HAVE BEEN
PASSIONATE AND GREAT ADVISERS.
FINALLY I WANT TO TALK ABOUT
SOMETHING I'M EXCITED ABOUT
THAT'S BEEN PART OF THE PLAN FOR
"ALL OF US" SINCE THE BEGINNING,
PEDIATRICS.
WE HIRED A YEAR AGO OUR FIRST
DIRECTOR OF PEDIATRICS.
OVER THAT TIME WE'VE BEEN
BUILDING OUT A PROTOCOL.
WE'VE GONE THROUGH THE IRB.
WE HAVE BEEN FIGURING OUT
BIOSPECIMENS, SURVEY MODULES,
ALL THESE COMPONENTS.
WE ARE NEAR THE STAGE OF
STARTING END TO END TESTING OF
WHAT THIS LOOKS LIKE AND I'M
LOOKING FORWARD TO KICKING OFTEN
-- KICKING OFF THE ENROLLMENT
OF PEDIATRICS.
WE WILL MOVE TO A BETA PHASE, ON
THE RIGHT NSA APPROACH, 0-4 WITH
A PROTOCOL THAT IS NOW IRB
APPROVED FOR 0-6, WE'LL DEVELOP
PROTOCOLS FOR 7-12, AND 13 AND
OVER WITH IDEA HOW THEY
TRANSITION TO BECOMING ADULT
PARTICIPANTS AT THE AGE OF 18.
VERY EXCITED ABOUT THIS
COMPONENT OF OUR PROGRAM.
WITH THAT, THANK YOU VERY MUCH.
I'M HAPPY TO TAKE ANY QUESTIONS.
>> I'M SURE THERE ARE GOING TO
BE MANY QUESTIONS.
LET'S START WITH BRIAN.
>> THANKS FOR THIS PRESENTATION.
IT'S FASCINATING ALL THAT YOU'VE
DONE.
I HAVE MORE OF A META SCIENCE
QUESTION.
I WAS IMPRESSED WITH THE
DASHBOARD FOR RETURNING RESULTS
TO PARTICIPANTS.
THAT'S SOMETHING THAT A LOT OF
FOLKS IN THE SCIENTIFIC
COMMUNITY WOULD STRUGGLE TO
IMPLEMENT NOT HAVING THE
INFRASTRUCTURE, EVEN LARGE
UO1s, NETWORK STUDIES TO
RETURN RESULTS LIKE THAT.
I'M WONDERING ABOUT THOUGHTS OR
PLANS MAKING SOME OF THAT
APPROACH AVAILABLE TO THE
SCIENTIFIC COMMUNITY WHETHER
MAKING CODE FOR DASHBOARD
AVAILABLE OR DOING TECH
TRANSFER, BECAUSE I THINK IN
THIS ERA OF INCREASING MISTRUST
OF SCIENCE THE BETTER WE CAN
SHARE, VALUE TO THE SCIENTIFIC
COMMUNITY AND I HAVE QUESTIONS
HOW PEOPLE REACT TO RESULTS.
MAYBE TALK ABOUT THE TECHNOLOGY
AND HOW THAT MIGHT BE SHARED.
>> YEAH, I LOVE THE SECOND
QUESTION TOO THAT YOU'RE NOT
ASKING.
IN TERMS OF THE FIRST WE DO TRY,
WE WANT THESE THING TO BE AS
MUCH AS WE CAN SHARED, ADOPTED,
OPEN SOURCE, SHARE CODE.
ONE OF THE SIMPLEST THINGS
FOLLOWING FAIR PRINCIPLES WITH
DATA AND ANALYSES IN OUR CLOUD
IN A NOTEBOOK MEANS SOMEONE CAN
JUST LOOK IT UP, TAKE THAT CODE,
ADAPT SOMEPLACE ELSE.
ANOTHER THING IS PROMOTION AND
COMMON DATA MODEL.
ANALYSIS CAN HAPPEN ONE PLACE
AND ANOTHER, FACILITATE THAT
MORE SIMPLY.
AND THAT IS SOMETHING THAT WE'VE
BEEN WORKING WITH U.K. BIOBANK,
HARMONIZING AS MUCH AS WE CAN IN
TERMS OF DEVELOPING DATA MODELS.
AND PROCESSES AND ALSO
INTERNATIONAL 100,000 PERSON
CONSORTIUM, IF WE CAN MAKE
AVAILABLE, SURVEYS ARE FREE TO
USE, POSTED ONLINE.
IN TERMS OF TECHNOLOGY WE TRY TO
MAKE OPEN SOURCE FOR PEOPLE TO
ADOPT.
>> SPECIFICALLY
PARTICIPANT-FACING PLATFORM
PARTICIPANTS CAN LOG IN AND SEE
RESULTS, THAT'S WHAT I WAS
SPECIFICALLY ASKING.
HOW YOU'RE PROVIDING RESULTS
BACK, SEE SURVEYS AND COMPARE
WITH OTHER PEOPLE, IS THAT
SOMETHING YOU CAN GO TO GITHUB
AND DOWNLOAD?
THERE'S TREMENDOUS VALUE FOR
SCIENTIFIC COMMUNITY TO ADVANCE
HOW WE SHARE RESULTS BACK TO THE
PEOPLE WHO GAVE US THEIR DATA.
>> THAT'S RIGHT.
WE CAN'T -- I THINK PARTS ARE
NOT LIKE DOWNLOADABLE FROM
GITHUB.
REAM
REALLY ONE OF THE HARD PARTS,
WHAT'S THAT PDF OR WEBSITE LOOK
LIKE, WHAT LANGUAGE DO YOU PUT
AROUND VARIANTS THAT YOU'RE
RETURNING?
I WOULD THINK WE COULD MAKE A
LOT OF THAT AVAILABLE.
GOOD CALL.
I'LL LOOK INTO THAT.
>> THAT WOULD BE PERHAPS A WHOLE
SIDE INITIATIVE BUT REALLY
ADVANTAGEOUS TO THE BROADER
SCIENTIFIC COMMUNITY.
>> AGREED.
>> WE KEEP TELLING FOCUS, FOCUS,
FOCUS.
>> THANKS, JOSH.
THIS IS A STUNNING PRESENTATION.
NIH IS LUCKY TO HAVE YOU, THE
COUNTRY IS LUCKY TO HAVE THIS
PROGRAM.
SIX SHORT QUESTIONS, HOPEFULLY
SHORT.
I COULD ASK QUESTIONS FOR HOURS.
FIRST, HEREDITARY DISEASE RISK
GROUP REPORTING 59 GENES, IF NEW
GENES ARE ADDED, IS THERE ANY
PROCESS TO GO BACK PERIODICALLY
REANALYZE, REINFORM FOLKS.
>> YEAH, MAYBE WE SHOULD ANSWER
AS YOU ASK THEM.
IF THERE'S SIX I WON'T REMEMBER
THEM.
THERE IS A PROCESS.
IT GOES THROUGH THE FDA AND IT
IS A LITTLE BIT -- IT'S GOING TO
BE A PROCESS THAT'S NOT AS --
DOESN'T MOVE WITH THE ALACRITY.
81 GENES, 3.2, WE WILL BE
LOOKING AT HOW WE EXPAND THAT
LIST.
>> HOW GOOD IS STICKINESS AND
HOW ARE YOU SOLVING WHERE OTHERS
FAIL.
>> A BIG CHALLENGE AS WE THINK
ABOUT OUR PROGRAM.
I'M GOING TO ANCHOR THIS WITH
WHERE WE STARTED AND WE'LL MOVE.
I CAN TELL YOU THAT THERE'S A
DIFFERENCE, LET ME START WITH
PASSIVE REESSENTIAL. --
RETENTION.
LONGITUDINAL DATA THAT PEOPLE
LET US COLLECT FOR THEM LIKE
ELECTRONIC HEALTH RECORD.
THAT'S REALLY GOOD.
WE'RE WORKING THROUGH CLAD TO
EXPAND, PEOPLE AUTHORIZED AT
HIGH RATES.
IF YOU THINK ABOUT PEOPLE,
METRIC WE LOOK AT IS RIGHT NOW
IN TERMS OF ACTIVE RETENTION HOW
MANY PEOPLE HAVE DONE SOMETHING
IN THE LAST 18 MONTHS, FILLED
OUT A NEW SURVEY.
SOMETIMES THERE'S ACTUALLY NO
NEW SURVEY FOR THEM TO DO
BECAUSE THEY DID IT RIGHT AT THE
BEGINNING OR THEY ARE -- THERE'S
A VARIETY OF CIRCUMSTANCES.
SOMETIMES THOSE NUMBERS
ARTIFICIALLY DECREASE BECAUSE
THEY HAVE DONE ALL THEY CAN DO.
IF YOU GIVE THAT NUMBER, THAT
NUMBER IS ABOUT HALF OF OUR
PARTICIPANTS RIGHT NOW HAVE DONE
SOMETHING IN THE LAST 18 MONTHS.
THAT DOESN'T MEAN LOG IN.
THAT MEANS COMPLETE A NEW
SURVEY.
WHEN WE FIRST LOOKED AT THAT
NUMBER, BELIEVE IT OR NOT IT WAS
20%.
SO IT'S INCREASED A LOT THROUGH
ACTIVE ENGAGEMENT EFFORTS THAT
WE'RE DOING.
>> .
>> ANY CHANCE TO MODERNIZE?
WE OURSELVES GIVE YOU DATA FROM
OUR PARTICIPANTS, BUT FHIR,
OTHERS.
>> WE'RE LOOKING AT ALL OF THAT.
WE HAVE PARTICIPANT
AUTHORIZATION FOR THEIR
ELECTRONIC HEALTH RECORDS,
THAT'S PART OF WHAT CLAD IS
GOING TO DO.
WE WOULD LOVE FOR EACH TO
EVOLVE.
WE HAVE PARTICIPANT MEDIATED
DONATION AS WELL AND WE HAVE --
I THINK OVER 60,000, THE NUMBER
MIGHT BE 80,000.
I CAN'T REMEMBER THE EXACT
NUMBER THAT HAVE DONATED
PARTICIPANT RECORDS IN ADDITION
TO WHAT WE HAVE COLLECTED FROM
HEALTH CARE PROVIDER
ORGANIZATIONS.
AND WE HAVEN'T PUSHED THAT.
IT'S PEOPLE THAT FIGURE OUT HOW
TO NAVIGATE THROUGH THE SITE
WHICH IS COMPLICATED RIGHT NOW
TO FIND THAT HAVE DONE THAT.
SO I THINK THAT IS A MODALITY
THAT PEOPLE WILL USE AND SO THAT
IS A FHIR SOURCE, AND YOU WOULD
SEE THE FHIR SOURCES AND OTHER
SOURCES THAT WE WILL BE
EXPANDING INTO.
I WANT TO USE THEM ALL IS THE
SHORT ANSWER, EVERYTHING WE CAN
DO TO CREATE AS COMPLETE A
PICTURE.
>> I'M COMING FROM SILICON
VALLEY, NEIGHBORS AND FRIENDS
ASK ME WHEN COMPANIES CAN ACCESS
THIS DATA.
THE UK BIOBANK IS NOT THE MOST
DATASET.
I THINK YOU HAVE SOME PLAN FOR
THEM.
>> I'M GLAD TO HEAR OF INTEREST.
RIGHT NOW IT'S OPEN TO ACADEMIC,
EDUCATIONAL, AND NON-PROFIT IN
HEALTH CARE.
IN SOME CASES ACTUALLY THERE
HAVE BEEN INDUSTRY PARTNERS THAT
FALL INTO ACADEMIC ENTITY FOR
INSTANCE THAT ALREADY HAVE SOME
ACCESS.
WE HAVE CONTINUALLY OPENED
ACCESS AS WE STARTED OUR MODEL,
TO GET OUT THERE EARLY WITH THE
OVERSIGHT WE PROVIDE FROM
RESOURCE ACCESS BOARD AND OTHER
PROTECTIONS AROUND THE DATA.
AND GROW IT OVER TIME.
AND SO THAT'S BEEN OUR APPROACH
AS WE DEMONSTRATE SAFETY,
LESSONS LEARNED, TALK TO
PARTICIPANTS.
WE'RE SEEKING TO CONTINUE TO DO
THAT.
>> PATIENTS ARE CONSENTED.
THE BIGGEST SURPRISE IS FDA
INVOLVEMENT, I WAS THINKING CLIA
AND OTHERS BUT HOW IS THE FDA
INVOLVED WITH THIS?
>> PART OF RETURNING RESULTS,
NOT WITH THE OVERSIGHT OF A
PROVIDER.
THEY CAN ENROLL FROM ANYWHERE IN
THE COUNTRY BY JOINING "ALL OF
US."
>> THE HIGHEST PRAISE TO SAY
THAT WAS FIRE WITH THREE EMOJIS,
JOB WELL DONE.
TWO QUESTIONS AND A SUGGESTION.
FIRST HOW IS THE POSTBAC DOING,
ARE THEY DOING?
>> THE POSTBAC IS FIRST YEAR MED
STUDENT YOU -- NOW, DOING
GREAT.
>> WONDERFUL.
THIS IS HOW YOU BRING TOGETHER A
LOT OF PRIORITIES, ENGAGING
COMMUNITIES, DIVERSE
COMMUNITIES, BUILDING TRUST,
FINDING NEW BIOLOGICAL TARGETS,
I'M WONDERING HOW YOU THINK
ABOUT NOT ONLY SHARING FRAMEWORK
FOR ACCESSING DATA BUT TRAINING
PEOPLE HOW TO DO SCIENCE THIS
WAY.
ARE THERE OPPORTUNITIES TO THINK
ABOUT HOW YOU DISSEMINATE NOT
JUST POSTBACS HERE BUT THE
COUNTRY, USING A FRAMEWORK THIS
IS HOW YOU DO THIS TIME OF
SCIENCE THAT BUILDS TRUST AND
DELIVERS BACK, HAVE YOU THOUGHT
--
>> GREAT SUGGESTION.
WE'VE DONE SOME, WE HAVE A
RESEARCH AMBASSADOR NETWORK,
PAIRING THEM WITH OTHER
RESEARCHERS, AND WE HAVE BAYLOR
COLLEGE OF MEDICINE'S PROGRAM
FOCUSED ON OTHER LOWER RESOURCED
INSTITUTION RESEARCHERS IN FOR
TRAINING AS WELL.
THERE'S ALSO SOME EFFORTS
THROUGH CTSA PROGRAM FOCUSED ON
DOING THIS, DISSEMINATING
LOCALLY OR REGIONAL OR
INTERNATIONALLY SOME TRAINING
MODULES.
IT'S GREAT TO KEEP GOING.
>> MORE OPPORTUNITIES FOR
SCALING AND TEACHING PEOPLE HOW
TO DO SCIENCE THIS WAY, AND THE
VALUE OF IT, AND HOW YOU CAN DO
BETTER SCIENCE.
WELL DONE.
THE FINAL POINT, EXPANDING THE
PEDIATRIC POPULATION WE HEARD
ABOUT ECHO, ALREADY ENROLLING,
ABCD, GETTING THE MOMS, ALL THE
WAY THROUGH.
PERHAPS THAT'S A NICE PLACE TO
THINK ABOUT ENROLLING.
YOU HAVE AN ENGAGED POPULATION,
TONS OF DATA, YOU COULD SUPPORT
THAT IN A WAY TO FIND PATTERNS.
>> WE HAVE GOOD RELATIONSHIPS
WITH THOSE PROJECTS AND OFFICES,
AND WE'LL CERTAINLY CONTINUE TO
ENGAGE WITH THEM AND SEE WHAT
THE OPPORTUNITIES ARE.
>> HI, JOSH.
THANKS AGAIN FOR EXCELLENT
PRESENTATION.
EXCITING TO SEE ALL THE
PROGRESS.
PARTICULARLY PARTNERSHIP WITH
PARTICIPANTS, ANOTHER POINT OF
HIGHLIGHT IS DEFINITELY THE
NATIONAL LIBRARY OF MEDICINE
NETWORK WHICH HAS A LOT OF
OUTREACH AND I KNOW DOING A
GREAT JOB OF THAT.
YOU HEARD ABOUT CONNECTIONS
INTERNALLY WITH OTHER PROGRAMS,
I MUST EMPHASIZE THOSE ARE HEARD
YESTERDAY ABOUT NEW PROGRAMS,
EXISTING PROGRAMS, THE TRIBAL
APPROACH AGAIN IS ALSO
CONNECTING CAN EXISTING COHORTS,
STRONG HEART AND OTHERS, WOULD
BE EXCELLENT WAY OF GOING ABOUT
IT.
FINALLY, KIND OF A
QUESTION/COMMENT.
INTERNATIONALLY THERE'S GREAT
INTEREST IN DOING BIOBANKS THAT
ESSENTIALLY DO THE SAME AS "ALL
OF US" AND CONNECT IN A
FEDERATED WAY SO WE DON'T NEED
TO CENTRALIZE DATA YOU PROBABLY
ARE BEING APPROACHED TO SEVERAL
OF THOSE, HOW DO YOU SEE THE
PATH MOVING FORWARD TO DO AN
EXTENSION INTERNATIONALLY THAT
WOULD EVEN ACCELERATE A LOT OF
THIS OTHER RACE AND ETHNICITY,
DIVERSITY, THAT YOU ALREADY
HAVE?
>> I THINK THAT'S A GREAT WE.
WE NEED RESEARCH TO HAPPEN IN
SCALE ACROSS REALLY THE WORLD.
AS YOU POINT OUT WE HAVE RICH
DIVERSITY HERE IN THE UNITED
STATES BUT WE ALSO WANT TO
FACILITATE ACROSS THE WORLD AND
SET A MODEL, TAKE AS MUCH OF THE
LESSONS AROUND TOOLS WE'VE
LEARNED AND ACCELERATE AND SHARE
THAT AS WE CAN.
OUR MOST ACTIVE DISCUSSIONS
RIGHT NOW HAVE BEEN WITH SOME OF
OUR BRITISH COLLEAGUES THROUGH
THE U.K. BIOBANK, GENOMICS
ENGLAND, BUT THROUGH THE IHCC WE
HAVE A NETWORK ACROSS THE WORLD
THAT WE HAVE BEEN TALKING ABOUT
ENGAGING WITH AND SHARING AS
MUCH AS WE CAN.
HOW ARE WE GOING TO DO THAT IS
AN OPEN QUESTION.
THE WORLD IS JUST MOVING IN
THESE LARGE BIOBANKS TO MORE OF
A CLOUD-BASED MODEL.
GONE WILL BE THE DAYS OF
DOWNLOADING DATA.
THAT MAKES SENSE.
IF YOU PUT THAT DOWNLOADING, THE
AVERAGE TIME IT WOULD HAVE TAKEN
INDIVIDUAL TO DOWNLOAD THE
AMOUNT OF GENOME DATA WE HAVE IF
YOU USE U.K. BIOBANK DATA THAT
THEY HAVE THROUGHPUT WOULD BE
SIX MONTHS.
SO THAT'S NOT FEASIBLE.
IN CONTRAST ENOUGH, MY POSTBAC
STUDENT DID HIS GWAS, POINT AND
CLICKED, GOT HIS ANSWER IN 30
MINUTES.
SO IT REALLY IS A FASTER WAY TO
DO THE ANALYSIS.
IT'S A BETTER WAY, SAFER, ALLOWS
US TO HARMONIZE AND
REPRODUCIBILITY SHOOTS THROUGH
THE ROOF.
I THINK FEDERATION IS A BIG PART
OF THIS.
THERE'S A LOT OF DISCUSSION ON
TRUSTED RESEARCH ENVIRONMENTS,
AS YOU KNOW WELL, LUCILA, THERE
WILL BE DIFFERENT WAYS THEY MOVE
TOGETHER AND COMMON DATA
ELEMENTS IS IMPORTANT.
ONE IS PIPELINES AND PROCESSING
OF GENOMIC DATA, WHICH IS FAR
HEAD, AND AS MUCH AS WE CAN HAVE
COMMONALITIES IN OTHER KINDS OF
DATA SOURCES THAT WOULD BE
BETTER AS WELL.
WE TRY TO SHARE ALL THAT WE CAN
IN THOSE FRONTS, TRYING TO BE A
FORCE TOWARDS A GREATER
COMPATIBILITY.
ON THE COHORT LEVEL, EHR LEVEL.
>> GARTH?
>> YOU'RE GIVING COMPLICATED
INFORMATION TO PEOPLE WITH
DIFFERENT STAGES OF THEIR
SOCIOECONOMIC STATUS, CULTURAL
STATUS, ALL DYNAMICS, PRESENTED
AN EXAMPLE IN TERMS OF YOUR OWN
DATA WHICH IN ITSELF IS
COMPLICATED.
EXPLAIN HOW YOU'RE ENGAGING HOW
THE INFORMATION IS SHARED IN A
PRODUCTIVE WAY TO ALLOW
COMMUNITIES OF ALL KINDS TO
GRAPPLE AND UNDERSTAND THAT
INFORMATION AND WHEN YOU GIVE
THEM SERIOUS INFORMATION, THE
GENETIC COUNSELING, WE LEAVE
THEM IN A BETTER PLACE, NOT A
WORSE PLACE.
THAT'S ONE.
THE SECOND QUESTION CAN YOU
DESCRIBE DIVERSITY OF
LEADERSHIP, BUT THE DIVERSITY
AND STRATEGY MAKING PROGRESS IN
TERMS OF WHAT YOU'RE DOING AND
HOW YOU'RE THINKING THAT THROUGH
AND HOW GOVERNANCE IS BEING
EXECUTED ON.
DOES THAT MAKE SENSE?
>> I THINK SO.
LET ME ANSWER THE FIRST AND COME
TO THE SECOND.
THE FIRST QUESTION ABOUT
SUPPORTING OUR PARTICIPANTS WE
AS YOU RIGHTLY AND WONDERFULLY
POINT OUT, WE HAVE DOMAINS OF
DIVERSITY WITH PARTICIPANTS.
IT'S REALLY IMPORTANT TO US.
AND THAT IS ONE OF THE REALLY
KEY FACTORS OF HAVING OUR
PARTICIPANTS AT THE TABLE WHEN
WE HAVE DEVELOPED THESE FORMS,
TESTED THEM, WITH THEM, AND OF
COURSE NORMAL THINGS LIKE IRB
AND FDA.
LOOKING AT THEM AS WELL.
HAVING THOSE GENETIC COUNSELORS
AVAILABLE, ALL RESULTS BEING
RETURNED THROUGH GENETIC
COUNSELORS AS KEY PART OF WHAT
WE'RE DOING AS WELL FOR THE
DISEASE RISK AND AVAILABLE FOR
THE PHARMACOGENETICKIC RESULTS
AS WELL.
WHAT WE'RE FINDING THROUGH THE
SURVEYS THAT WE HAVE DONE ON
AFTER IT'S RELEASED AND GENETIC
COUNSELING APPOINTMENTS THROUGH
LOOKING AT THE MATERIALS AND
PRE-TESTING BEFORE WE LAUNCHED,
THEY ALL DO SEEM TO ALIGN WITH
THE FACT THAT PEOPLE DO SEEM TO
UNDERSTAND AND HAVING HIGH
CUSTOMER SATISFACTION FEEL LIKE
QUESTIONS ARE ANSWERED, THOSE
KINDS OF MATERIALS.
NOW, WE'RE ALSO STILL YOUNG AND
THERE ARE MORE THINGS TO DO, TO
FOLLOW UP, BECAUSE WE'VE ONLY
BEEN RETURN THESE HEALTH-RELATED
RESULTS FOR RIGHT NOW JUST AT A
YEAR.
AND OF COURSE THAT PACE IS
ACCELERATED AS WE'VE GONE ON
TIME.
THERE'S MORE WORK TO DO TO MAKE
SURE THAT THOSE EARLY FINDINGS,
YOU KNOW, CONTINUE TO PLAY OUT
WITH UNDERSTANDING.
I THINK THE SECOND WAS AROUND
THE MAKEUP OF OUR AWARDEES,
DIVERSITY.
IS THAT CORRECT?
>> NO, YOU ANSWERED WITH THE
FIRST QUESTION, MORE ABOUT
LEADERSHIP AND STRATEGY AND
INCLUDING DIVERSE COMMUNITIES.
YOU DID A GREAT JOB WHO IS
RECEIVING BUT ALSO THINKING
THROUGH THE CONVERSATION EARLIER
ABOUT HAVING PEOPLE AT THE
TABLE, AT THE GOVERNANCE TABLE,
AT THE BIGGER TABLE, NOT THE
RECIPIENT TABLE WHICH WE OFTEN
CELEBRATE BUT THAT'S ONLY ONE
COMPONENT.
THINKING THROUGH YOUR
LEADERSHIP, STRUCTURES USED AS
MACROGOVERNANCE, DOES THAT MAKE
BETTER SENSE?
>> YES, I'M GLAD TO BE ABLE TO
ELABORATE AS WELL.
WE DO HAVE PARTICIPANTS AT
REALLY A GREAT GOVERNANCE
COMMITTEE LEVEL, MY ADVISORY
PANEL, MY -- THE EXECUTIVE
COMMITTEE, STEERING COMMITTEE,
SCIENCE COMMITTEE, EACH OF THESE
HAS PARTICIPANT AMBASSADORS,
COMMUNITY ENGAGEMENT AWARDS WE
TRY TO HAVE THAT IN THE FABRIC
OF OF COURSE WE DO.
>> THANK YOU.
>> HOWARD?
>> THANK YOU FOR THE OUTSTANDING
PRESENTATION, IMPRESSED BY THE
PROGRESS AND BY THE ABILITY TO
RETURN INFORMATION TO
PARTICIPANTS WHICH MUST BE A LOT
OF -- ACTUALLY A RESOURCE AND
EFFORT.
MY QUESTION IS ABOUT WHAT DO YOU
RETURN AS BEING RESULTS,
BASICALLY GATED ON A SUBSET
READY TO INTERPRET OR DEAL WITH,
WHAT ARE PROSPECTS OF GIVING
PEOPLE ACTUAL GENOME SEQUENCE, A
BRCA VARIANCE, I WANT TO KNOW MY
ENTIRE RISK, SEE ALL THE OTHER
GENES.
I WANT TO JOIN ANOTHER STUDY,
HOW DO I DO THAT?
>> I'M NOT SURPRISED TO HEAR YOU
ASK THIS QUESTION.
IT IS SOMETHING THAT COMES FROM
DIFFERENT PARTICIPANTS THAT
THINK ABOUT THE SCALE AND WHAT
ELSE THEY COULD DO WITH THESE
KINDS OF DATA.
WE DO HAVE A SMALL NUMBER OF
PEOPLE LIKE YOURSELF THAT ASK
THESE.
THE THINGS ON THE ROADMAP,
PRIORITIZATION THROUGH
DEVELOPING PROCESSES AND WHAT WE
TAKE TO THE FDA AND OUR PROCESS
HERE BASED ON WHAT PARTICIPANTS
TELL US.
THEIR PRIORITIES.
AND SO IT IS ON THE ROADMAP.
I DON'T HAVE A TIMELINE FOR IT
AT THIS POINT.
>> YEAH, I WANT TO MAKE THE
POINT THIS MIGHT GO TO LIKE WHAT
EXACTLY IS HAPPENING, HOW DO YOU
MAKE DECISIONS, IT'S ALL THERE,
IF YOU WANT, YOU CAN SEE IT.
>> ANY ADDITIONAL COMMENTS OR
QUESTIONS?
I'LL TURN IT BACK TO YOU.
>> WE'LL TAKE A SHORT BREAK.
THANK YOU VERY MUCH, JOSH.
THAT WAS REALLY A TOUR DU FORCE,
WE'LL TAKE A BREAK AND LET ME
SEE WHEN WE WANT TO GET US BACK
HERE.
YEAH, 10:45 WE'LL SEE YOU BACK. THANKS.
OKAY, EVERYBODY, LET'S GET READY TO RESTART.
OKAY.
THANKS, EVERYBODY.
>> OKAY.
ALL RIGHT.
NOW FOR SOMETHING TOTALLY
DIFFERENT, NOT REALLY, ACTUALLY.
SOMETHING THAT DOVETAILS WITH
WHAT YOU HEARD IN "ALL OF US,"
BUT ALSO TAKES US IN A REALLY
EXCITING DIRECTION, I THINK.
WE'RE GOING TO GET AN UPDATE
FROM RADx, AND LET'S SEE,
MAYBE -- WE HAVE PRESENTING DR.
SUSAN GREGURICK ASSOCIATE
DIRECTOR FOR DATA SCIENCE AT
NIH, ELISEO STABLE-PEREZ,
DIRECTOR OF NIMHD; TARA SCHWETZ,
DEPUTY DIRECTOR FOR PROGRAM
COORDINATION; BRUCE TROMBERG
DIRECTOR NIBIB; AND RICK
WOYCHIK, NIEHS.
>> THANK YOU.
WE'RE EXCITED TO PRESENT AN
OVERVIEW AND UPDATES AND
ACCOMPLISHMENTS OF RAPID
ACCELERATION OF DIAGNOSTICS
PROGRAM, RADx, THIS MORNING.
SO, THIS IS A REMINDER, RADx
PROGRAM WAS DEVELOPED TO SPEED
INNOVATION IN DEVELOPMENT,
COMMERCIALIZATION,
IMPLEMENTATION OF COVID-19
TESTING.
I JUST WILL TAKE A FEW MINUTES
TO PROVIDE AN OVERVIEW OF THE
PROGRAM AND TURN IT OVER TO MY
AMAZING COLLEAGUES TO PROVIDE
UPDATES ON EACH OF THE
INDIVIDUAL PROGRAMS.
RADx-TECH, DR. BRUCE TROMBERG.
DR. PERES-ESTABLE, DR. WOYCHIK,
RADx RADICAL AND SUSAN
GREGURICK.
THIS MAY BRING BACK MEMORIES.
IT MAY BE FAMILIAR.
YOU MAY REMEMBER SITTING IN CAR
LINES, VERY LONG CAR LINES,
WAITING TO HAVE A SWAB DEEPLY
INSERTED UP YOUR NOSE FOR PCR
TESTING.
THAT DOESN'T HAPPEN ANYMORE.
NOW WE CAN COMFORTABLE TEST
OURSELVES RELIABLY AT HOME IN A
REAM LESS INVASIVE WAY THAT'S
AFFORDABLE, AND IF WE THINK
ABOUT HOW WE GOT TO THIS POINT,
RADxs PLAYED A ROLE IN THAT
PROCESS.
IN 2020, WE NEEDED A LOT OF
TESTING, ACCESS ABLE AND
RELIABLE.
TO FILL THIS URGENT NEED NIH
CREATED THE RADx INITIATIVE IN
APRIL OF 2020.
AGAIN, AT A TIME WHEN TESTING
WAS DIFFICULT TO COME BY AND CAR
LINES THAT YOU SAW WERE JUST
BEING SET UP.
THE PROGRAM ENHANCED ACCESS TO
THOSE WHO NEEDED IT MOST.
SO, AS YOU HEARD, THERE ARE FOUR
MAJOR RADx PROGRAMS.
RADx-TECH WHICH IS THE
INNOVATION FUNNEL ARM DESIGNED
TO COMPRESS THE CUSTOM AREA
TECHNOLOGY DEVELOPMENT TIMELINE
FROM YEARS TO MONTHS.
RADX-UP AIMED TO ASSESS AND
EXPAND COVID-19 TESTING FOR
UNDERSERVED AND/OR VULNERABLE
POPULATIONS.
REALLY GET THE TEST OUT TO THE
PEOPLE WHO NEEDED IT MOST.
AND HELP TO UNDERSTAND HOW AND
WHETHER THEY USE THIS TEST.
FOR RADx RADICAL, RADx RAD,
DEVELOPED TO BE FOCUSED MORE ON
LONGER-TERM APPROACHES BUT TO
THINK ABOUT HOW TO DEVELOP NEW
NOVEL NON-TRADITIONAL APPROACHES
THAT ADDRESSED CURRENT GAPS IN
OUR COVID-19 TESTING.
FINALLY THE DATA HUB PROVIDES
ACCESS TO AND ALLOWS RESEARCHERS
TO ANALYZE CURATE AND
DE-IDENTIFIED COVID-19 DATA IN
THE CLOUD.
SO NOW I'LL TURN IT OVER TO
BRUCE AND HE CAN TALK A LITTLE
BIT ABOUT RADx-TECH AND WHAT
THEY HAVE BEEN WORKING ON.
>> ALL RIGHT.
THANK YOU, TARA.
THANKS TO MY COLLEAGUES.
IT'S BEEN AN INCREDIBLE
EXPERIENCE WORKING TOGETHER.
HOPEFULLY WE CAN CONTINUE TO
KEEP THIS UP IN VARIOUS WAYS,
WE'VE BEEN DISCUSSING THAT QUITE
A LOT.
FROM THE RADx-TECH POINT OF
VIEW, AS TARA MENTIONED, I'LL
PUT A FEW MORE DETAILS TO HER
BIG PICTURE HERE.
IF WE GO BACK TO APRIL OF 2020,
THE COUNTRY WAS DOING ABOUT 8
MILLION TESTS, LESS THAN 8
MILLION, IN LABORATORIES
PRIMARILY, FEW MEDIUM COMPLEXITY
TESTS OUT THERE DONE SORT OF AT
POINT OF CARE BUT BY PARA
PROFESSIONALS OR PROFESSIONALS.
SO, FRANCES WAS CONTACTED BY
SENATOR ALEXANDER WHO CHAIRED
THE HEALTH COMMITTEE, I'M
CONCERNED THE TEST ROLLOUT HAS
BEEN ROCKY, SO ARE YOU WORKING
ON THIS?
FORTUNATELY DR. COLLINS HAD BEEN
PUTTING US THROUGH THESE SPRINTS
FOR ABOUT, I DON'T KNOW, THREE
WEEKS.
WE CAN ALL REMEMBER THESE.
AND HE KNEW VERY WELL AT NIBIB
WE EFFECT US ON THINGS WE COULD
DO, EXPANDING DIAGNOSTICS,
DIGITAL HEALTH PLATFORMS, WE HAD
A CHANCE TO COMMUNICATE WITH
SENATOR ALEXANDER.
I WAS A NEW DIRECTOR AT THE TIME
AND HE DIDN'T REALLY UNDERSTAND
WHAT I WAS TALKING ABOUT.
FRANCIS SAID IT'S LIKE A SHARK
TANK.
WE NEED A SHARK TANK AND
AMERICAN INGENUITY.
A WEEK AFTER THAT CONVERSATION
THERE WERE A ROLLOUT FOUR DAYS
AFTER THE EDITORIAL IN THE POST,
CONGRESS HAD THE FOURTH
SUPPLEMENTAL, $1.5 BILLION TO
THE NIH, FOR TESTING.
AND I PRACTICALLY FELL OUT OF
MY SEAT, THAT EXCEEDED OUR
ANNUAL BUDGET.
WE'RE IN BIG TROUBLE.
WE'VE GOT TO DO SOMETHING
QUICKLY.
WE PULLED TOGETHER AND ASSEMBLED
THESE PROGRAMS.
WE HAD ALREADY BEEN WORKING ON
THE PROGRAM, I'LL TELL YOU THE
EVOLUTION, BUT WE LAUNCHED ON
APRIL 29, TO CHANGE TESTING
PARADIGMS.
LABORATORIES ARE OKAY BUT IF
YOU'VE GOT A PANDEMIC AND MANY,
YOU KNOW, MILLIONS OF PEOPLE WHO
NEED TESTING IT'S NOT AN
EFFECTIVE WAY TO REACH PEOPLE.
WE WANTED TO GET TO POINT OF
CARE, OVER THE COUNTER TESTS,
TESTS IN THE BATHROOM, OUR
ORIGINAL VISION.
ON TOP OF THAT THE HELP
COMMITTEE, THE SENATOR SAID THIS
IS GOING TO BE OVER BY THE FALL
IF YOU CAN GET THESE TESTS DONE,
SO WE NEED ALL THESE TESTS OUT
IN FIVE, SIX MONTHS.
SO EVERYBODY CAN GO BACK TO
SCHOOL AND GET BACK TO NORMAL
LIFE.
WE WERE UNDER PRESSURE TO DO
THAT BY THE FALL OF 2020.
YOUR MAJOR VEHICLE HERE WAS THIS
INNOVATION FUNNEL, SHARK TANK.
WE WERE ABLE TO LAUNCH SO
QUICKLY, AS ALL INSTITUTES HAVE,
WE HAD ALREADY INVESTED IN
NETWORKS TO BE ABLE TO MAKE THIS
HAPPEN.
I KNEW THAT OUR COMMUNITY WAS
CAPABLE OF RESPONDING, THE
INNOVATION AND ENTREPRENEURIAL
COMMUNITY CAN DO SOMETHING
POWERFUL.
WE BUILT AROUND WHAT WE CALL OUR
POINT-OF-CARE TECHNOLOGY
RESEARCH NETWORK, POCTRN.
THAT'S A U54 NETWORK.
IT HAD JUST BEEN RENEWED.
WE ASKED THE ENTIRE NETWORK
WHICH IS COMPOSED OF JOHNS
HOPKINS, UMass, NORTHWESTERN,
GEORGIA TECH, EMORY, MGH, TO
SHIFT AND FOCUS ENTIRELY ON
DEVELOPING DIAGNOSTIC TESTS FOR
COVID.
AND EVERYONE SAID OKAY.
WE WERE FORTUNATE EVERYONE
AGREED AND WAS SHARING IN THAT
COMMON AMBITION AND GOAL.
THE MAIN VEHICLE WAS THE SHARK
TANK TO START OFF WITH.
WE HAD TO CREATE SOME NEW
ELEMENTS OR WORKING STRUCTURES
WITHIN POCTRN, A CORE DO
PHYSICALLY VALIDATE EVERY
POTENTIAL NEW TECHNOLOGY AS IT
CAME OUT, REALLY UNDERSTAND IF
IT WORK.
AND DETERMINE WHETHER OR NOT IT
MADE SENSE FOR US TO INVEST THE
MONEY THAT WE HAD IN DE-RISKING
AND PROMOTING AND ACCELERATING
THAT TECHNOLOGY.
THAT CORE CONTINUES TO EVALUATE
EVERY TEST FOR ITS PERFORMANCE
WITH EVERY VARIANT THAT COMES
OUT.
SO IT'S STILL A LEGACY CORE.
WE HAVE A STANDARD TRIAL,
DIGITAL TRIAL DESIGN CORE AT
UMass SO WE'RE ABLE TO QUICKLY
MAIL TESTS OUT TO PEOPLE, HAVE
PEOPLE MAIL BACK TO US SWABS SO
WE COULD DO COMPARISONS WITH NEW
TECHNOLOGY AS WELL AS
ESTABLISHED TECHNOLOGIES, AND
USE THE ENTIRE COUNTRY AS A
CATCHMENT AREA.
I'LL COME BACK TO IMPORTANT
FINDINGS FROM THAT THAT HAVE
CHANGED FDA REGULATORY POLICY
AND CLINICAL PRACTICE.
FINALLY A DEPLOYMENT CORE.
AT THE TIME AS EVERYONE WAS
SCALING UP TESTING, TERMS
MATERIALS AND SUPPLIES BECAME
SCARCE, TINY COMPONENTS, BIG
COMPONENTS IN DEVICES.
A CORE THAT DWELT THAT AND
INTERFACED WITH THE DEPARTMENT
OF DEFENSE TO GET PROCUREMENT.
YOU HAVE NO IDEA WHAT'S GOING
HAPPEN NEXT IN A PANDEMIC.
WE THOUGHT THE INNOVATION FUNNEL
WOULD BE ENOUGH BUT IT WASN'T.
WE HAD TO CREATE SEVERAL MORE
PROGRAMS THROUGHOUT THE PANDEMIC
STARTING WITH INNOVATION FUNNEL,
YES COVID TEST IN COLLABORATION
TO GET TESTS, THE PROTOTYPE FOR
COVID.GOV ONLINE, DO THESE AT
HOME, TELL US DID YOU LIKE IT,
DID IT WORK.
IT WAS A VERY IMPORTANT TEST BED
TO DETERMINE WHETHER PEOPLE
WOULD ACCEPT HOME TESTING AND IF
IT COULD DO IT EFFECTIVELY.
PUBLIC HEALTH FOLKS HAVE
QUESTIONS ABOUT WHETHER PEOPLE
COULD TEST THEMSELVES AND REPORT
THAT INFORMATION RELIABLY.
WE HAD TO BUILD A DIGITAL HEALTH
PLATFORM, CREATE STRUCTURED
INFORMATION OTHER DATA USING
FHIR AND HL7 TO TRANSMIT THAT
INFORMATION FROM PEOPLE'S HOMES
OR POINT OF CARE IS TO PUBLIC
HEALTH AUTHORITIES.
WE HAD TO DEAL WITH NEW
VARIANTS, CREATED A VARIANT TEST
CORE.
WE ACCELERATED AUTHORIZE A GOAL
WAS TO ACCELERATE AUTHORIZATIONS
AWAY WASN'T SYNCHRONY.
YOU COULD REPORT YOUR TEST
ANONYMOUSLY, YOU SHOULD PUT THAT
BOOK MARK IN YOUR PHONES.
HOME TEST TO TREAT PROGRAM IS I
THINK THE FORERUNNER OF WHAT
WILL BE POPULAR IN THE FUTURE,
TESTING AND TREATING ENTIRELY IN
ONE STROKE AT HOME.
AND WE'VE FOCUSED ON TEST
REDESIGN FOR ACCESSIBILITY, SO
WE HAVE A NEW SERIES OF NEW
TESTS THAT ARE COMING OUT THAT
ARE MORE ACCESSIBLE TO PEOPLE
WITH VISUAL IMPAIRMENTS,
DEXTERITY, COGNITIVE, SIMPLER
AND MORE POWERFUL.
BOTTOM LINE AS YOU LOOK AT THE
INNOVATION FUNNEL AND
INDEPENDENT TEST ASSESSMENT
PROGRAM, PARTNERSHIP WITH THE
FDA, THOSE WERE THE TWO BIG
DRIVERS GETTING TESTS FROM THE
BENCH TOP TO FULLY DISSEMINATED
MATCHED DEVICES.
THEY ACCOUNT FOR INCREASE BY 8
BILLION TESTS OVER THREE YEARS.
PRIMARILY POINT OF CARE AND OVER
THE COUNTER TESTS, WE INCREASED
LABORATORY TESTS, ALL KINDS OF
TESTS.
THE BIG STORY IS DIAGNOSTIC
PARADIGM SHIFT.
IF WE LOOK AT FEBRUARY 2022,
THERE WERE 1 BILLION OVER THE
COUNTER TESTS DISTRIBUTED.
PRIOR TO THAT POINT, I THINK FOR
HOME PREGNANCY TESTS, THE TOLD,
BIGGEST AMOUNT, WAS ROUGHLY 8
MILLION IN A YEAR.
JUST IN FEBRUARY A BILLION TEST,
2.5 BILLION IN THE YEAR, A
PARADIGM SHIFT THAT WAS
REMARKABLE.
ONE SLIDE ON THIS, INCREDIBLY
IMPORTANT, OUR CLOSE PARTNERSHIP
WITH THE FDA.
USUALLY THE FDA IS QUITE
AMBIGUOUS, THEY SAY HERE'S THE
GENERAL GUIDELINES AND TELL US
WHAT GOT.
WE WORKED OUT A SERIES OF
MODULES IN ADVANCE, TESTING
COMPANIES WE WERE SORT OF THE
HONEST BROKER IN BETWEEN THE
COMMERCIAL ENTITY AND THE FDA
AND DESIGN CLINICAL TRIALS WITH
APPROVAL OF FDA AND TAKE ALL THE
DATA AS STREAMING OUT OF THE
CLINICAL AND ANALYTICAL STUDIES,
SHOW TO THE FDA IN REAL TIME, SO
THEY COULD MAKE A DECISION ON
EVERY MODULE TO CUT
AUTHORIZATION TO 50 TO 55 DAYS.
KIND OF REMARKABLE SINCE
NORMALLY THE AUTHORIZATIONS WERE
TAKING SIX MONTHS, EVERYBODY GOT
ON BOARD.
THE OUTPUT OF THAT ALONE
INCREASED TESTING CAPACITY BY
FOUR BILLION LATERAL FLOW
ASSAYS, RESULTED IN SIGNIFICANT
FDA POLICY CHANGES.
IF YOU USED YOUR TEST SERIALLY,
THAT SERIAL LABELING, A BLANKET
SERIAL LABELING FOR ALL
AUTHORIZED TESTs, CAME AS THE
RESULT OF LONGITUDINAL STUDIES
OF 7,000 SUBJECTS IN DIGITAL
TRIALS.
WE SHOWED IT VERY EARLY ON IN
THE PANDEMIC, IN A SMALL STUDY
UNIVERSITY OF ILLINOIS BUT FDA
WANTED OVERWHELMING EVIDENCE, WE
DID SHOCK AND AWE, TWO IN 48
HOURS WERE AS GOOD AS A SINGLE
NUCLEIC ACID TEST.
EARLY IN THE PANDEMIC YOU COULD
SAY PPA IS 95% BUT YOUR LIMIT OF
DETECTION MAY HAVE BEEN A
MILLION COPIES PER MILL.
IF THE VIRAL LOAD IS IN YOUR
POPULATION THAT WAS HIGH LIKE
THEY WERE, THEN EVERYTHING
LOOKED GOOD BUT LATER ON HAD
FLUCTUATIONS IN VIRAL LOADS,
ABLE TO DISCONNECT AND GET
AUTHORIZATIONS BASED ON LOD.
IT'S AN INTERESTING STORY.
STANDARDIZED ANALYTICAL MEASURES
WITH PEDIATRIC SELF-SWABBING, SO
KIDS HAD TO HAVE PARENTS SWAN.
KIDS WHO NATURALLY LIKE TO STICK
THEIR THINGS UP THEIR NOSES
COULD SWAB AS WELL, FDA SAID WE
BELIEVE IT, YOU CAN DO PEDIATRIC
SWABBING.
DIGITAL CLINICAL TRIALS.
AGAIN, A MAJOR ADVANCE, ENORMOUS
AREA FOR POTENTIAL GROWTH.
WE LOVE THE RADx PROGRAM BUT
THE CONCEPT IS STILL GOING ON.
WHILE WE MAY NOT BE DOING AS
INTENSIVELY COVID STUFF JUST
TAKING THE IDEA OF ACCELERATION
WITH INNOVATION FUNNEL AND
CLOSER RELATIONSHIPS WITH THE
ITAP PROGRAM WHICH CONTINUES,
WE'VE APPLIED TO OVER THE
COUNTER AND POINT OF CARE COVID
MULTIPLEX TESTS, A TESTS OUT
NOW, WE'VE INCREASED PERFORMANCE
OF TEST, COMING OUT, SO LIMITS
OF DETECTION ARE WAY BETTER THAN
THE ORIGINAL ROUND SO YOU CAN
ONLY DO ONE TEST.
WE GOT THE FIRST POINT OF CARE
Mpox AUTHORIZATION TEST, NOW
WORKING ACTIVELY ON MULTIPLEX
TEST WHICH OFFICE OF THE
DIRECTOR BOTH LARRY AND TARA
HAVE BEEN VERY EXPORTIVE.
HEP-C, THAT NEEDS A POINT OF
CARE DIAGNOSTICS FOR TEST TO
TREAT, HIV AND VIRAL LOAD, NIH
BLUEPRINT PROGRAM WHICH IS
CONSORTIUM OF 12 NIH INSTITUTES
ADVANCED MED TECH FOR
NEUROTECHNOLOGIES, MATERNAL
HEALTH TECHNOLOGIES WITH NICHD
AND OTHER NIH PARTNERS, THOSE
ARE ACTIVE PROGRAMMING WITH COOL
THINGS THAT ARE GOING ON AND WE
JUST LAUNCHED FETAL MONITORING
TECHNOLOGIES WITHIN NICHD, I'M
MEETING ON TUESDAY WITH OUR LEAD
ORGANIZER TO REVIEW ALL THE
APPLICATIONS.
WE HAVE WONDERFUL APPLICATIONS
COMING IN, SUPER EXCITED ABOUT
THAT.
SO WHAT'S NEXT?
THIS IS A PROJECTION OF THE HOME
MARKET GROWTH.
SO WHAT'S HAPPENED, BILLIONS OF
TESTS DISTRIBUTED OUT THERE,
PEOPLE ARE JUST EXPECTING TO BE
ABLE TO HAVE POWERFUL TOOLS AT
HOME.
WE SEE HOME AND POINT-OF-CARE
TESTS ARE REALLY WHAT CONSUMERS,
WHAT THE PUBLIC ARE LOOKING FOR.
THIS WILL CONTINUE TO GROW.
COVID PARADIGM SHIFT HAS DRIVEN
THIS AMAZING INVESTMENTS IN
DIAGNOSTICS DURING COVID NEED TO
BE LEVERAGED TO OTHER PATHOGENS
AND CHRONIC DISEASES.
AND THIS REALLY OPENS THE FIELD
TO PREVENTION AND NEW WAYS TO DO
DIAGNOSTIC-LED PRECISION
MEDICINE.
WITH TELEHEALTH AND
TELEMEDICINE, THIS IS AN
ENORMOUS OPPORTUNITY TO IMPROVE
ACCESS AND OUTCOME.
A BIG CHALLENGE IS HOW DO YOU
STANDARDIZE THESE THINGS?
IT'S THE WILD WEST.
THESE ARE ALL ESSENTIALLY
INVISIBLE TO THE ELECTRONIC
HEALTH RECORD AND THE
CONVENTIONAL HEALTH CARE SYSTEM.
SO THE PERSON MAY KNOW IT BUT
YOUR DOCTOR MAY NOT KNOW UNLESS
THEY TAKE YOUR WORD FOR IT.
THIS IS A MAJOR CHALLENGE.
WE NEED TO WORK PARTNERSHIPS IN
ORDER TO DO THAT.
>> OKAY.
ELISEO.
>> NOW FOR A DIFFERENT
PERSPECTIVE BUT EQUALLY BALANCED
WITH RADx PROGRAM.
YOU ALL WILL REMEMBER THAT IN
MARCH OF 2020, DR. FAUCI WITH
PRESIDENT TRUMP AT THE TIME
TALKED ABOUT THE
DISPROPORTIONATE BURDEN OF
AFRICAN AMERICAN COMMUNITIES
FROM COVID-19.
AND WHEN THIS TURNED OUT TO BE
AN INCREASE IN NOT ONLY CASES
BUT REALLY IN HOSPITALIZATIONS
AND DEATH, PRIMARILY BORN BY THE
LATINO OR HISPANIC COMMUNITY,
BLACK OR AFRICAN AMERICAN,
AMERICAN INDIAN AN ALASKA
NATIVE, QUITE STRIKING AND LED
FRANCIS AND LARRY TO ALLOCATE AT
THE TIME FUNDS FOR THE RADX-UP
FROM THE APPROPRIATIONS, WASN'T
DRIVEN BY THE SENATORS, IT WAS
REALLY FROM NIH.
AND WITH TARA AND RICHARD HODES
WE STOOD UP THE RADX-UP PROGRAM.
WE CAN'T TAKE CREDIT FOR WHAT
HAPPENED BUT WE WERE PART OF THE
SOLUTION.
THE VACCINATION RATES FOR LATINO
AND AFRICAN AMERICAN COMMUNITIES
BY SEPTEMBER OF 2022 WAS THE
SAME AS FOR WHITES.
CLOSE TO 70%.
WE SEE A PLUMMETING OF
HOSPITALIZATION AND DEATH RATES,
NOT EQUAL TO WHITES BUT MARKED
DECREASE FOR MOST AFFECTED
COMMUNITIES.
THE TWO TO THREE YEARS OF LOST
LIFE EXPECTANCY I FULLY EXPECT
WE'LL RECOVER A SIGNIFICANT
AMOUNT OF THAT.
SO, WHAT WAS RADX-UP?
SO, NOT QUITE LIKE INNOVATION
FUNNEL BUT IN THOSE EARLY DAYS
OF MAY AND JULY, MOBILIZING THE
RESEARCHERS THAT HAD MOSTLY BEEN
FUNDED BY NIH OVER THE COURSE OF
THE PRIOR 30 OR SO YEARS
INCLUDING MYSELF WHEN AT UCSF,
TO SAY WE NEED TO DO SOMETHING,
WE NEED TO GET PEOPLE INVOLVED
IN THIS, TO RESPOND TO THIS
PANDEMIC, SO COMMUNITY
ENGAGEMENT EXPERIENCE, GOING
THROUGH SUPPLEMENTS, THROUGH
EXISTING CENTERS AND GRANTS,
THAT HAD COMMUNITY ENGAGED
PROGRAM, PHASE 1 AND PHASE 1A
AND B WAS THE APPROACH, DOING A
RESEARCH PLAN TOGETHER WITH A
COMPRESSED TIME PARTNERSHIPS
BASED ON TRUST, MUTUAL BENEFITS,
COMPLEMENTARY SKILLS, FOCUS ON
HEALTH.
WE COULDN'T HAVE INVESTIGATORS
LEARN THESE SKILLS.
WE HAD TO GO TO PEOPLE WHO
ALREADY KNEW AND HAD THE
CONNECTIONS IN THE COMMUNITY.
FOR THE MOST PART I THINK WE
SUCCEEDED TO EXPAND CAPACITY,
DEPLOY TESTS, DO MITIGATION
STRATEGIES AND DEPLOY
INTERVENTIONS.
IN ADDITION THERE WAS A
COMPONENT OF SOCIAL, ETHICAL,
BEHAVIORAL FACTORS, TARA WAS THE
FIRST TO PROPOSE AMONGST US AS
WE WERE REALLY BUILDING THIS ON
THE FLY AS WE MOVED ON.
IN SUMMARY, WE'RE NOW IN PHASE
4.
PHASE 1 HAD TWO PARTS.
WE FUNDED A LOT OF PROJECTS
BETWEEN APRIL WHEN APPROPRIATED
TO END OF SEPTEMBER AND
BEGINNING OF OCTOBER, FOR THE
FIRST TWO 1A AND 1B PHASES.
MASSIVE AMOUNT OF WORK BY STAFF,
CO-LEADS, MONICA WEBB HOOPER
DEPUTY DIRECTOR NIMHD AND WILSON
COMPTON.
WHY CAN'T WE GET KIDS BACK IN
SCHOOL?
BEING OUT OF SCHOOL ON A SIDE
NOTE MAY BE ONE OF THE LASTING
ADVERSE EFFECTS OF THE RESPONSE
TO THE PANDEMIC THAT WE NEED TO
DEAL WITH AT SOME POINT.
THIS PROGRAM INITIALLY WAS CAN
WE GET KIDS BACK IN SCHOOL, IT
EVOLVED INTO STAYING IN SCHOOL,
BEING SAFE IN SCHOOL, CONTINUING
TO WORK ON SOCIAL, ETHICAL,
BEHAVIORAL BARRIERS.
THE VACCINE WAS OUT BY THEN.
ALSO WE WERE APPROPRIATED TO DO
TESTING, EXPANDED SLIGHTLY TO
INCLUDE ISSUES AROUND VACCINE
THAT WERE SECONDARY TO THE MAIN
GOALS.
BY PHASE 3 WE WERE FOCUSED ON
RAPID TESTING, WHAT YOU HEARD
FROM BRUCE WAS MORE
DISSEMINATED.
WE NO LONGER WERE PROPOSING OR
PEOPLE WERE DOING STUDIES USING
PCR TESTING BUT NOW DOING THE
HOME TEST, RAPID TEST APPROACH
FOCUSED ON THAT.
PHASE 4 WE'VE FUNDED ALREADY
FOUR R21s TO DO CROSS-STUDY
ANALYTICS, IMPLEMENTATION,
DISSEMINATION AND IMPLEMENTATION
PROJECTS.
THIS IS A SNAPSHOT OUR CENTER
FOR DATA COORDINATION GATHERED
TOGETHER.
THIS IS FUNDED AT DUKE, UNC.
GISELLE IS ON THE MEETING WAS A
CO-P.I. AROUND CRITICAL LEADER
WITH WARREN KICKY AND MICKEY,
450,000 TESTS, LAUNCHED BY THE
CDCC AND RAPID RESEARCH AWARDS.
SO THIS IS THE MAP WE GREW TO
SHOW AND LOVE.
WE REALLY INCLUDED ALL 50
STATES, U.S. TERRITORIES,
INCLUDING PACIFIC THAT ARE NOT
SHOWN ON THIS SLIDE.
HAWAII AND PACIFIC TERRITORIES,
EIGHT TIME ZONES, COORDINATING
CENTER IN NORTH CAROLINA.
EVEN THOUGH NOT EVERYBODY STATE
HAD AN AWARD, THERE WERE
PARTICIPANTS INVOLVED FROM EVERY
STATE.
I'LL MENTION NOW AND SUSAN WILL
TALK MORE ABOUT THIS, THAT WE
FUNDED TEN PROJECTS FOCUSED ON
TRIBAL COMMUNITIES, THESE ARE --
YOU'LL HEAR MORE FROM SUSAN ON
THE TRIBAL DATA REPOSITORY
APPROACH, BUT WE FOCUSED ON THE
POPULATIONS DISPROPORTIONATELY
AFFECTED, SO AFRICAN AMERICANS,
LATINOS, AMERICAN INDIANS,
ALASKA NATIVES, ASIAN, NATIVE
HAWAIIANS, PACIFIC ISLANDERS,
VULNERABLE POPULATIONS FROM
MEDICAL OR SOCIAL PERSPECTIVE,
THE EXPANSION WAS BROAD AND
WE'RE NOW SEEING SORT OF THE
PRODUCTS OF IT.
THE SCHOOL-BASED PROGRAM WHICH
INCLUDED ABOUT $50 MILLION WORTH
OF AWARDS PUBLISHED TWO
SUPPLEMENTS IN PEDIATRICS, THE
RADX-UP COMMUNITY-BASED PROGRAM,
A YEAR AGO IN THE AMERICAN
JOURNAL OF PUBLIC HEALTH, PEER
REVIEWED COMPETITIVE SUBMISSIONS
I THINK MAYBE A THIRD OF THE
ONES SUBMITTED ENDED UP IN THE
JOURNAL.
WE WROTE -- CO-AUTHORED AN
EDITORIAL SORT OF MAKING THE
POINT.
THEY ARE WORKING ON A SECOND
SUPPLEMENT ABOUT TO COME OUT
LATER THIS -- IN EARLY 2024 AND
WE'LL SEE WHERE THAT LEADS.
THERE'S ALSO A NUMBER OF
INDIVIDUAL PUBLICATIONS MIGHT BE
WORTH CALLING OUT TOO.
THIS IS ON KEEPING CHILDREN SAFE
IN SCHOOL, OFFERING IN-SCHOOL
TESTING, INCREASED TESTING
UPTAKE, NURSING STAFF WERE
CRITICAL, ON SITE, WHAT TO DO
WITH POSITIVE TEST, MOTIVATIONS
WAS TO NOT HAVE CHILDREN BE SENT
HOME AND QUARANTINED LONG
PERIODS OF TIME, SHORTENING THE
PERIOD KIDS WERE ABLE TO BE IN
SCHOOL -- KEPT THEM FROM GOING
HOME AND STAYING HOME WHICH WE
KNOW ADVERSE EFFECTS THAT HAD.
IN THIS STUDY THERE WERE OVER
3,000 LATINO HISPANIC
INDIVIDUALS TESTS.
YOU IS IT CAN SEE THERE WAS A
FOCUS ON THE SUBPOPULATIONS,
COMPARISONS TO MEXICANS, SOUTH
AMERICANS WERE MORE LIKELY TO
HAVE BEEN VACCINATED, SPAN
SHALL-SPEAKING INDIVIDUALS MORE
LIKELY TO BE VACCINATED PARTLY
IN PART DUE TO EFFECT IN LATIN
AMERICA THE UPTAKE OF VACCINES
WAS SOMETHING COMMON AND BROAD,
THE VACCINATION RATES FOR
CHILDHOOD VACCINATIONS APPROVED
BY THE AMERICAN COUNTRIES IS
COMPARABLE TO THE UNITED STATES.
SO THE CULTURE WAS NOT ANTI-VAX
BUT MORE PRO.
YOU CAN SEE THAT REFLECTED IN
THESE DATA.
TO WIND UP, WHAT DID WE LEARN
FROM THIS?
WHAT HAVE WE LEARNED?
WE'RE NOT DONE YET.
WE HAVE A WHILE TO GO TO FINISH
THE PROJECT.
SUPPORTING THIS COMMUNITY
ENGAGED NETWORK OF THESE
COMMUNITY ACADEMIC PARTNERSHIPS
ON A MASSIVE SCALE IN A RUSHED
CONTEXT TO ADDRESS A PANDEMIC,
SO PUBLIC HEALTH EMERGENCY, WE
WERE ABLE TO IMPLEMENT
PRINCIPLES OF THINGS THAT PEOPLE
HAD BEEN WORKING ON FOR A LONG,
LONG TIME.
OF COURSE, WE MADE MANY
MISTAKES.
IT'S OPTIMALLY NOT SOMETHING YOU
DO IN EIGHT MONTHS.
IT'S SOMETHING YOU DO WITH MORE
MUTUAL EXCHANGE AND PARTNERSHIP
AND DEVELOPMENT, BUT WE SHOW IT
DO BE DONE AND PRIMARILY IN A
POSITIVE -- WITH POSITIVE
RESULTS.
WE GOT OVER 80% OF PROJECTS TO
DO COMMON DATA ELEMENTS ON A
SAID AGREED UPON BY NIH ACROSS
THE BOARD AND THEN ON RADX-UP
THERE WAS A SECOND SET OF COMMON
DATA ELEMENTS THAT WERE
IMPLEMENTED BY THE MAJORITY OF
PROJECTS.
IDEALLY I THOUGHT EVERYBODY
SHOULD DO IT, RIGHT?
SCIENTIFIC ARGUMENT WAS THERE
BUT THERE WERE ALWAYS 100
REASONS WHY DIFFERENT PROJECTS
DIDN'T WANT TO DO.
SOME WERE LEGITIMATE, OTHERS
WERE WE CAN'T DO THAT TO THE
COMMUNITY, HAVE YOU TESTED?
NO.
THERE WERE COMMON THREADS.
A BIG LEARNING LESSON.
WE'VE EMBRACED THIS IN NIMHD.
DATA SHARING, CENTRAL
REPOSITORY, THAT MECHANISM
COMMUNITY-ENGAGED NETWORK
DISSEMINATE AND RETURN RESULTS,
WE DIDN'T LEVERAGE BECAUSE THAT
WASN'T OUR GOAL BUT THERE'S A
TREMENDOUS AMOUNT OF POTENTIAL
AND THERE ARE OTHER ACTIVITIES
THAT WILL DO THAT.
THEN HOW MUCH EFFORT IT TAKES TO
CONTINUOUSLY SUSTAIN TRUST.
YOU NEED COMMITTED SCIENTISTS
WILLING TO WALK THE STREET, GO
TO THE CURBSIDE AND WORK WITH
INDIVIDUALS IN THE COMMUNITY AS
WELL AS LEADERS IN THAT
COMMUNITY THAT UNDERSTAND OUR
PERSPECTIVE ON THIS SO THAT WE
CAN WORK TOGETHER.
OF COURSE, THEY DO VALUE
TREMENDOUSLY WHEN NIH IS AT THE
STABLE AS -- TABLE AS WELL.
I'LL STOP AND TURN IT BACK.
>> TEAM WORK.
WOULD YOU MIND ADVANCING THE
SLIDES FOR ME.
>> I'M GOING TO.
>> SO I CAN LOOK AT THE
AUDIENCE.
I'LL TELL YOU ABOUT THE RADx
RAD PROGRAM.
I RECOGNIZE WHILE I WAS THE
PROGRAM CHAIR, IT WAS JUDITH
COOPER DEPUTY DIRECTOR AT NIDCD
AND TRISH POWELL, NIAAA
ASSEMBLED A TALENTED WORKING
GROUP, 12 PROGRAM OFFICERS
ACROSS 7 ICs THAT MADE THIS
HAPPEN.
MY HAT'S OFF TO THEM.
NEXT SLIDE.
PAY ATTENTION HERE.
RADx RAD PROGRAM IS REALLY
ABOUT ADVANCING INNOVATIVE
RADICAL NEW NON-TRADITIONAL
APPROACH FOR SARS-COV-2 TESTING,
BUT ALSO TECHNOLOGIES THAT COULD
BE APPLICABLE, THAT COULD HELP
POSITION THE NATION FOR THE NEXT
PANDEMIC THAT'S INEVITABLY GOING
TO BE COMING DOWN THE ROAD.
SO, WHAT KIND OF INNOVATIVE NEW
TECHNOLOGIES CAN WE DEVELOP AND
DEPLOY?
THERE WERE TWO PHASES.
PHASE 1 INVOLVED $108 MILLION
THAT WAS DEPLOYED TO 49 AWARDS
TO 45 INSTITUTIONS, 20 STATES, A
COUPLE OF SMALL AWARDS.
I DON'T HAVE TIME IN MY
REMAINING EIGHT MINUTES TO GO
THROUGH ALL EIGHT AREAS BUT
THERE WERE SOME PROJECTS THAT
INVOLVED THE DEVELOPMENT OF NEW
MACHINES, A GREAT EXAMPLE HAS
BEEN DAN TAGLE FROM NCATS,
DEVELOPING THE ELECTRONIC NOSE.
PEOPLE INFECTED WITH SARS-COV-2
EMIT SPECIFIC VOLATILE ORGANIC
COMPOUNDS ON THE SKIN OR BREATH.
THEY DEVELOPED A MACHINE TO
DETECT THESE VOLATILE ORGANIC
COMPOUND.
IMAGINE THE NEXT PANDEMIC IF
YOU'RE BOARDING YOUR PLANE,
SOMETHING SUSPICIOUS THAT YOU
MAY BE INFECTED, THERE MAY BE A
BREATHALYZER TEST TO DETERMINE
WHETHER OR NOT YOU'RE INFECTED.
NOT ALL PROJECTS INVOLVE HIGH
TECH INSTRUMENTATION.
A GREAT EXAMPLE WAS SUSAN
SULLIVAN AT NIDCD DEPLOYED --
DIFFERENT FLAVORED
CONFECTIONARIES, CANDIES.
MANY OF YOU KNOW PEOPLE
INFECTED, AT LEAST EARLY
VARIANTS, SENSE OF TASTE AND
SMELL.
HIGHLY EFFECTIVE TO DETERMINE
WHO WAS INFECTED.
TALKING ABOUT PEDIATRIC
PATIENTS, EASIER TO GIVE KIDS A
PIECE OF CANDIES THAN JAM A
COTTON SWAB UP THE NOSE.
I'VE DESCRIBE FOUR PROJECTS
THROUGH THE PROGRAM.
PHASE 2 INVOLVED DEPLOYING $75
MILLION OF FUNDING TO TAKE
PROMISING PROJECTS FROM PHASE 1
AND HELP THEM COMMERCIALIZE.
PART OF PHASE 2 ALSO I THINK
SOMETHING THAT TARA BROUGHT UP
INITIALLY, THIS WHOLE ISSUE OF
LONG COVID.
SO THERE ARE ALL OF THESE
ACCUMULATING DATASETS, SO THERE
WERE SOME INDIVIDUALS FROM A FEW
I.C.s THAT DECIDED THEY WANTED
TO LAUNCH THE LONG COVID
COMPUTATIONAL CHALLENGE.
N3C CHALLENGE TO DEVELOP
INNOVATIVE A.I. AND M.L. TOOLS
TO SORT THROUGH DATASETS.
THEY HAVE DEVELOPED REMARKABLY
COOL TOOLS.
THERE WERE EIGHT CATEGORIES OF
PROJECTS SUPPORTED.
ON THE RIGHT THE DATA
COORDINATION CENTER, ALL THE
DATA FROM THESE PROJECTS WAS
ASSEMBLED BY THE DCCC, FED INTO
SUSAN AND COLLEAGUES INTO THE
RADx DATA HUB.
THE FIRST ONE IS WASTE WATER
DETECTION.
I WAS PRETTY SKEPTICAL EARLY ON.
LARRY KNOWS THAT.
AND ACTUALLY LEONARDO ANGELONI
IN NIDA, PROGRAM OFFICER, WHO
CONVINCED ME OTHERWISE.
THE IDEA IS SIMPLE.
ARE THE PEOPLE WHO ARE INFECTED,
DUGS THE VIRUS FROM THE JAILS
THEY ARE IN, DORMITORIES THEY
ARE IN, HOSPITALS THEY ARE IN,
COMMUNITIES THEY ARE IN, DOES
THIS VIRUS ACTUALLY MAKE IT INTO
WASTE WATER?
SECONDLY IS THERE A WAY TO
CORRELATE LEVEL OF SARS-COV-2 OR
VIRUS IN WASTE WATER WITH
CLINICAL OUTCOMES IN THE
COMMUNITIES?
BOTTOM LINE AFTER FUNDING THESE
THE ANSWER IS YES AND YES, IT
ENDS UP IN WASTE WATER, GRANTEES
DEVELOPED INNOVATIVE TOOLS FOR
PROCESSING WASTE WATER AND
ACTUALLY A GROUP AT THE
UNIVERSITY OF NORTH CAROLINA
CHEMISTRY DEPARTMENT THAT
DEVELOPED A DIGITAL PCR MACHINE,
A SMALL TWO BY TWO CENTIMETER
CHIP.
THEY USED INCREDIBLY CLEVER
FLUORESCENCE MULTI-TASKING
STRATEGIES TO LOOK AT MULTIPLE
SEQUENCE VARIANTS WITHIN THE
VIRUS AND OTHER INFECTIOUS
AGENTS.
HIGHLY PRODUCTIVE PROGRAM, MANY
OF YOU MAY KNOW THIS IS BEING
USED BY MANY COMMUNITIES
INCLUDING MY OWN TO MONITOR THE
PANDEMIC.
SO NEXT SLIDE.
SO ANOTHER -- NEXT SLIDE.
THERE WE ARE.
THIS IS THE EXOSOME TECHNOLOGY.
THERE ARE ARE THESE
EXTRACELLULAR VESICLES, EVS,
THAT BRANCH, BUD OFF EUKARYOTIC
CELLS.
TURNS OUT THAT DAN TAGLE IN
NCATS WAS WORKING WITH
INVESTIGATORS AT HOPKINS, MASS
GENERAL, OHIO STATE, UCLA,
STUDYING THESE EVS AND DEVELOPED
INNOVATIVE MICROFLUIDIC DEVICES
ON THE RIGHT-HAND SIDE, THE
CHANNELS.
THEY COULD FRACTIONATE BASICALLY
SALIVA OR BLOOD, FRACTIONATE AND
ISOLATE THESE EVS.
THEY MADE THE DISCOVERIES, WAIT
A MINUTE, THE VIRUS LOOKS VERY
SIMILAR TO AN EV.
THEY COULD FRACTIONATE THE VIRUS
AND FRACTIONATE THE EV, YOU CAN
USE AN ANTIBODY TO DETECT SPIKE
PROTEIN, RPCRR TO LOOK AT
PROTEIN CONTENTS.
THEY COULD DIAGNOSE IF YOU WERE
PROSES POSITIVE, BUT THE
CONTENT, THE TIMES OF ANTIBODIES
OR PROTEINS, microRNAs, WERE
PREDICTIVE WHETHER THE COVID-19
INFECTION WOULD BE SEVERE, MILD,
FURTHERMORE MAKING CONNECTIONS
WHETHER INDIVIDUALS COULD
DEVELOP LONG COVID.
COOL STUFF.
NEXT SLIDE.
THIS PROGRAM IS FROM NICHD.
WORKING ON THIS PREVAIL KIT,
PREDICTING VIRAL ASSOCIATED
INFLAMMATORY DISEASE IN
CHILDREN, IT SUPPORTS THIS
RESEARCH TO DEVELOP
NON-TRADITIONAL APPROACHES TO
CHARACTERIZE THE SPECTRUM, SUCH
AS MULTI-SYSTEM INFLAMMATORY
SYNDROME IN CHILDREN, MIS-C.
SO, THEY WORKED TOGETHER WITH
EIGHT TEAMS, SHOWN ON THE SLIDE
HERE.
OVER 8,000 INDIVIDUALS.
REACHED OUT AND THERE WAS A
BROAD PATIENT POPULATION, 75
SITES ACROSS 30 STATES,
INTERNATIONAL COLLABORATORS, UK,
CANADA, AFRICA, ASIA, SOUTH
AMERICA, 30,000 INDIVIDUALS MOST
THROUGH ELECTRONIC HEALTH
RECORDS, AND IN THE END IT'S
HIGHLY PRODUCTIVE.
93 RESEARCH PUBLICATIONS, 65 IN
PREPARATION, THEY IDENTIFIED 10
GENES THAT YOU CAN LOOK AT THAT
ARE ALL PART OF IMMUNE
DYSREGULATORY PATHWAYS, HIGHLY
PREDICTIVE FOR MIS-C.
THEY DEVELOPED A SET OF FIVE
GENES THAT COULD CLEARLY
DIFFERENTIATE MIS-C FROM
KAWASAKI DISEASE AND OTHER
INFECTIONS IN CHILDREN.
HIGHLY PRODUCTIVE PROGRAM.
NEXT SLIDE.
JUST TALKING ABOUT THE PHASE 2,
L3C, SO IT WAS REALLY -- ORLANDO
LOPEZ, PART OF THE RADx RAD,
JOINED FORCES WITH YVONNE AND
ERIN, AND THEY DECIDED THAT
THERE ARE ALL THESE DATASETS,
MOST NOTABLY N3C DATA, AND COULD
WE USE THAT DATA TO DEVELOP
ALGORITHMS AND A.I. AND ML
MODELS TO PREDICT WHO -- WHICH
INDIVIDUALS ARE CURRENTLY
INFECTED, LIKELY TO DEVELOP LONG
COVID.
SO THE BOTTOM LINE IS THAT THEY
DID THIS AS A CHALLENGE GRANT.
IT WAS A MILLION DOLLARS PUT ON
THE TABLE.
FIRST PLACE WENT TO THIS
COMPANY, CONVALESCO, UNIVERSITY
OF CHICAGO, BOTTOM LIONEL THEY
ACHIEVED A .87 SCORE.
WHAT IT MEANS IS THAT IT WORKED
WELL.
AND SO THERE ARE PUBLICATIONS
THAT WILL BE COMING OUT, THESE
TOOLS WILL BE AVAILABLE ON
GITHUB.
SO IT'S PRETTY REMARKABLE.
THERE ARE NOW TOOLS THAT ARE
AVAILABLE TO PREDICT WHETHER
SOMEONE IS LIKELY TO DEVELOP
LONG COVID.
BOTTOM LINE THAT THIS IS A
HIGHLY PRODUCTIVE PROGRAM.
LOTS OF COOL INNOVATIVE THINGS.
SEVEN PROJECTS, THREE EUAs, 32
FILED PATENTS EMERGING FROM THE
ROOM, SOME WAS OPEN SOURCE, 23
PROJECTS, ACTIVE MEETINGS WITH
THE FDA, A LOT OF INTEREST IN
THIS.
26 PROJECT TEAMED TEN PROJECTS
AWARDED COMMERCIALIZATION
SUPPORT.
SO IT WAS FUN BEING PART OF THIS
BUT AGAIN IT'S TRISH AND JUDITH
THAT DESERVE THE CREDIT WITH
MEMBERS OF THE WORKING GROUP.
>> IT'S BEEN A PLEASURE WORKING
WITH MY COLLEAGUES.
WE'VE HAD SOME PRETTY AMAZING
ACCOMPLISHMENTS FROM RADx,
RAPID DIGITAL PCR TESTING TO
ENGAGING COMMUNITIES
UNDERREPRESENTED, IN TESTING,
AND IN VACCINATION, TO REALLY
COOL TECHNOLOGY LIKE DIGITAL
NOSE AND WASTE WATER DETECTION.
ANOTHER BY-PRODUCT IS ALL THE
DATA.
THERE'S A LOT OF IT.
SO SOME QUESTIONS EARLY ON THAT
RESEARCHERS WANTED TO ASK WHEN
THEY WERE ASKED ABOUT WHAT WOULD
YOU WANT TO DO WITH THIS DATA
WERE CAN WE THINK ABOUT THE
DIFFERENT PATHOGENESIS OF COVID
IN DIFFERENT POPULATIONS, LOOK
AT THE WAY THE VIRUS, THE
VARIANTS CHANGE OVER TIME AND
OVER SPACE BY MONITORING WATER
WASTE, ASSESS TECHNOLOGIES LIKE
PCR TECHNOLOGIES, AND FINALLY
WHAT IS THE EFFECT OF HAVING
OBESITY OR CARDIOVASCULAR
DISEASE ON YOUR COVID SYMPTOMS
AND DOES THAT CHANGE BY THE
POPULATION OR WHERE YOU LIVE OR
BY YOUR GENDER?
THESE ARE JUST SOME OF THE
DIFFERENT QUESTIONS THAT WE
ASKED RESEARCHERS, WHAT DO YOU
WANT TO DO WITH THIS DATA.
THEY CAME BACK WITH REALLY
INNOVATIVE THINKING.
YOU'VE SEEN THIS BEFORE.
THIS IS JUST A SENSE OF WHERE
THE DATA SOURCES ARE COMING FROM
THE COVID PROGRAM, WHAT I WANT
TO EMPHASIZE IS WHAT RICK WAS
TALKING ABOUT WHICH IS HOW WE
ORGANIZE THIS STRUCTURE OF THE
PROGRAM, AND EACH OF THE RADx
PROGRAMS, RADX-UP, RADx-TECH,
RADx HUB, IMPACTFUL DATA
COORDINATION CENTER, WORKED WITH
P.I.s, AND WAS DESCRIBED,
COMMON DATA ELEMENTS WE
REQUIRED.
GETTING P.I.s TO UNDERSTAND
WHY THEY WERE IMPORTANT,
COLLECTING NOT ONLY COMMON DATA
ELEMENTS BUT DATA MODELS FROM
EACH OF THE STUDIES.
THOSE COORDINATED CENTERS WORKED
WITH OUR DATA HUB, IT'S A
COLLABORATION BETWEEN STANFORD,
CURATION MANAGEMENT AND GETTING
THE DATA OUT TO RESEARCHERS
USING JUPYTER NOTEBOOK, R,
ROLLING OUT IN FEBRUARY AND
MARCH THESE AND OTHER
TECHNOLOGIES, THE GOAL TO GET
ALL OF THE RADx DATA, THERE'S
OVER A THOUSAND DIFFERENT TIMES
OF DATASETS, THERE'S 200 STUDIES
ACROSS ALL OF THE COUNTRY,
ACROSS FOUR PROGRAMS, ONE WE
DIDN'T TALK MUCH ABOUT BUT I'LL
TELL YOU ABOUT IS THE DIGITAL
HEALTH TECHNOLOGIES PROGRAM,
REALLY EARLY WEARABLE SURVEY FOR
MOBILE APP PROGRAM.
SOME OF THE FEATURES WE
REGISTERED ALL THE DATA IN
DBGaP, YOU CAN FIND AND SEARCH
THROUGH META DATA, ALSO OTHER
WAYS.
SECURE DATA ACCESS, COME INTO
OUR CLOUD ENVIRONMENT, MUCH LIKE
WHAT JOSH DESCRIBED, GET ACCESS
TO DATA, DISCOVER DATA THROUGH
MANY WAYS OF SEARCH AND
CERTAINLY WORK WITH DATA ON A
CLOUD-BASED WORKBENCH, NOT
DISSIMILAR FROM MANY OUR
PROGRAMS.
THIS IS ONE OF THE MORE
INTERESTING SLIDES.
IT TELLS YOU ABOUT THE DEPTH OF
THE DATA THAT WE'RE DEALING WITH
FROM RADx, OVER 138 STUDIES,
DIFFERENT VARIETY OF DATA TYPES,
SURVEY DATA, CLINICAL,
DIAGNOSTIC.
TO THE DIGITAL HEALTH
TECHNOLOGIES, WE'RABLE DATA.
THIS IS ONE PROGRAM WHERE DATA
LEVELS IN A PARTNERSHIP WITH
LINCOLN LAB AND M.I.T., IN THE
RAPIDS PLATFORM, IF YOU'RE
INTERESTED, MOSTLY STUDIES OF
WEARABLE AND SENSOR DATA, YOU
COULD GO FROM OUR SITE TO THEIR
SITE AND USE THAT DATA.
IT'S IMMENSE.
WE HAVE SNAPSHOT FROM ACROSS THE
PROGRAM BUT THE DATA IS QUITE
DIVERSE.
ONE OF THE THINGS THAT YOU'RE
GOING ASK ME ABOUT AS MANY
PEOPLE DO IS YOU HAVE PCR
TESTING DATA, SURVEY DATA,
HEALTH DATA, SOCIAL DETERMINANTS
OF HEALTH DATA.
THAT'S KIND OF A LOT OF
DIFFERENT DATA.
HOW ARE YOU MAKING THE DATA
HARMONIZE TO THE DEGREE YOU CAN
AND EARLY ON WE'RE ASKED TO MAKE
IT A.I. READY AND SERVE TO THE
COMMUNITY.
HERE IS WHAT WE DID.
ALL OF THE DATA HAVE DIFFERENT
SCHEMAS, DIFFERENT STANDARDS.
THERE'S DIFFERENT LEVELS OF
COMPLETENESS OF DATA AND META
DATA, WE WORK WITH DCCs ON
HARMONIZING COMMON DATA
ELEMENTS, TOOK ALL OF THE WORK
FROM THE COORDINATING CENTERS,
FURTHER HARMONIZED ON THE META
AND HARMONIZED ALL OF THE DATA
MODELS TOGETHER INTO ONE DATA
MODEL AND LOOKED AT C TO E
HOSTED BY NLM, HARMONIZED ON
THOSE COMMON DATA ELEMENTS SO
THAT WE COULD GET A CLUSTER AND
BEST TYPE OF HARMONIZATION THAT
WE COULD.
THIS IS BOTH MANUAL AND
AUTOMATED PROCESS.
RESEARCHERS STARTED LOOKING AT
LARGE LANGUAGE MODELS, CAN WE
USE NEW ADVANCES IN A.I. TO
BRING TOGETHER DATA.
THIS IS AN ONGOING AREA OF
RESEARCH.
FINALLY WE SERVE THE DATA UP TO
THE RESEARCH COMMUNITY.
IT IS TO THE BEST EXTENT
POSSIBLE HARMONIZED CERTAINLY ON
ALL THE COMMON DATA ELEMENTS,
SOCIAL DETERMINANTS OF HEALTH,
AS WELL AS MANY OF THE META DATA
THAT DESCRIBE THE EXPERIMENT.
WHAT WILL WE SEE IN THE FUTURE?
CERTAINLY RICHER WAYS TO EXPLORE
AND USE THE DATA, NEW
CAPABILITIES FOR THE DATA HUB
INCLUDING SAS, METRICS AS WELL
AS IMPROVEMENT AND BACK END OF
THE MANAGEMENT OF THE DATA.
THE MOST IMPORTANT
ACCOMPLISHMENT CERTAINLY OF
COURSE IS THE FACT WE LAUNCHED
THIS ALMOST ACTUALLY A YEAR AGO
TODAY.
IS THAT RECENTLY JUST ON
DECEMBER 1 WE ANNOUNCED THE
RADx TRIBAL DATA REPOSITORY
FOR INDIGENOUS INNOVATION,
BETWEEN STANFORD, NATIVE DATA
CONSORTIUM ON TRIBAL LANDS IN
THE CHEYENNE RIVER, SIOUX
RESERVATION, PARTNERSHIP WITH
UNIVERSITIES LISTED BELOW,
WISCONSIN, ARIZONA STATE,
UNIVERSITY OF WASHINGTON, OHIO
STATE, UNIVERSITY OF CALIFORNIA,
A NUMBER OF HEALTH SITES.
THE GOAL OF THE TRIBAL DATA
REPOSITORY IS TO IMPLEMENT
TRIBAL DATA SOVEREIGNLY IN
GOVERNANCE, THESE COMMUNITIES
WITH PARTNERSHIPS WILL MANAGE
THE DATA, WILL PROVIDE MECHANISM
FOR DATA ACCESS AS WELL AS THEY
WILL SERVE THE DATA UP IN A
REPOSITORY THAT'S ON TRIBAL
LANDS, IMPORTANT FOR US AS WE
EXPLORE NEW IDEAS FOR TRIBAL
DATA SOVEREIGN DID TY AND
GOVERNANCE.
>> I WANT TO MAKE SURE WE LEAVE
SOME TIME FOR QUESTIONS AND
COMMENTS YOU MIGHT HAVE.
YOU MAY HAVE TAKEN AWAY FROM
THIS THAT EACH OF THE PROGRAMS
HELPED TO RESPOND TO COVID-19.
BUT THEY HAVE ALSO SERVED TO
BUILD UP INFRASTRUCTURE,
RESOURCES, FRAMEWORKS,
CONNECTIONS, PARTNERSHIPS, ALL
OF THESE THINGS THAT WE HOPE
WILL BE ENDURING AND LONG
LASTING AND PREPARE FOR PUBLIC
HEALTH AND ENERGY HEALTH
EMERGENCY TIMES.
THE SECOND THING I WANT TO SAY,
A HUGE, HUGE THANK YOU TO FOLKS
HERE IN THE ROOM THAT WERE
INVOLVED IN LEADERSHIP AS WELL
AS THOSE NOT.
AND THE TEAMS ACROSS NIH,
MASSIVE NUMBER OF PEOPLE THAT
WERE INVOLVED IN THIS.
THIS WAS A TREMENDOUS AMOUNT OF
WORK, REALLY GRATEFUL TO THEIR
WORK AS WELL AS WORK OF THE
SCIENTISTS IN THE COMMUNITIES,
ACROSS THE U.S. WHO WERE
INVOLVED IN THIS EFFORT AND
HELPED MAKE IT A SUCCESS.
SO, WITH THAT WE'LL OPEN IT UP
FOR QUESTIONS.
>> OKAY, GREAT.
WHO WOULD LIKE TO START US OFF?
>> EXCITING PRESENTATIONS.
I'M LOST WITH THE RADx THIS
AND THAT.
IT'S GREAT BECAUSE IT'S
ENORMOUS.
RANDOM COMMENT MORE THAN A
QUESTION, A LOT OF WHAT YOU HAVE
SUCCEEDED IN BUILDING IS WHAT I
SEE GROUPS LIKE ARPA-H PROPOSING
TO DO ACTUALLY.
IN TERMS OF THEIR INVESTOR HUB,
DIFFERENT KIND OF HUBS, DATA
COMMONS BETWEEN THOSE, A COMMENT
THAT MAYBE THEY SHOULD BE
LOOKING AT WHAT YOU'VE ALREADY
BUILT.
>> COULD I TURN THAT INTO A
QUESTION?
SO THEY ARE.
WE'RE WORKING VERY CLOSELY WITH
ARPA-H AND RENEE WEGRZYN GAVE A
PRESENTATION AT THE NEW POCTRN
MEETING AS DID DR. BERTAGNOLLI,
INCREDIBLE EXCITEMENT FROM BOTH
OF THOSE.
AND IT'S NO COINCIDENCE BECAUSE
THEY ARE TRYING TO REACH THE
COMMUNITY AS INNOVATORS AND
ENTREPRENEURS AND THAT'S OUR
COMMUNITY, SO IT'S A PERFECT
PARTNERSHIP AND IT'S COMING AT
THE RIGHT TIME.
WE'RE SO EXCITED WE CAN SUPPORT
THE POCTRN NETWORK, AND WE JUST
RENEWED FOR TOTAL, WITH TWO
ADDITIONAL SITES OF $9 MILLION,
PER YEAR, IN PARTNERSHIP WITH
OTHER INSTITUTES AND CENTERS.
AND ARPA-H IS BUILDING NETWORKS
LIKE ON ANOTHER SCALE, AND IT'S
JUST INCREDIBLE, THE SYNERGY
BETWEEN ALL OF THIS AND
EXPERIENCE FROM PEOPLE WHO ARE
BATTLE TESTED AND BRINGING THOSE
THINGS WITH NEW CAPACITY AND
CAPABILITIES BY ARPA-H.
SO WE'RE SEEKING PARTNERSHIPS
OFTEN AND IN MANY, MANY AREAS.
>> CORY?
>> YES, THANK YOU FOR THAT
PRESENTATION.
VERY INFORMATIVE.
I HAVE ONE COMMENT OR ONE
QUESTION RELATIVE TO YOUR UNDER
SERVED POPULATIONS AS PART OF
THE VACCINE INTAKE ANALYSIS.
I WAS INVOLVED IN REVIEW OF
LITERATURE, PEOPLE OF COLOR,
HEALTH IMPLICATIONS, MAYBE A
YEAR AND A HALF AGO.
WE COULD NOT AS PART OF THE
RESEARCH TEAM, WE COULD NOT
IDENTIFY ANY LITERATURE IN THE
EXTANT PEER-REVIEWED
PUBLICATIONS THAT LOOKED AT THE
INTERSECTION OF DISABILITY AND
RACE AND VACCINE UPTAKE SO WE
IDENTIFIED THAT LACK OF
INFORMATION AS A RESEARCH GAP.
MY QUESTION IS IN TERMS OF THIS
INITIATIVE, IN THE PAST, HAVE
YOU ALL TARGETED DISABILITY AS A
STUDIED VARIANCE IN GRAPHICS AND
IF NOT ARE YOU PLANNING TO DO
THAT AS PART OF THE FUTURE DATA
COLLECTION ACTIVITIES?
>> THAT'S DIRECTED AT ME I
THINK.
AND BRUCE, RIGHT, YEAH, FROM THE
TECH PERSPECTIVE.
A QUESTION ON DISABILITY, I
THINK THAT'S ADAPTED FROM WHAT
THE CDC ASKS, WAS INCLUDED IN
THE TIER 1 COMMON DATA ELEMENTS.
I CAN TELL YOU THAT FOR SOME
PROJECTS THAT WAS AN ISSUE.
THEY DIDN'T WANT TO ASK THAT,
BECAUSE THEY DIDN'T THINK IT WAS
APPLICABLE TO THEIR COMMUNITY.
SO JUST AS AN ASIDE, THINGS WE
TAKE FOR GRANTED, OH, YEAH, WE
SHOULD DO THIS, SOME PEOPLE
RESIST.
TWO OF THE SCHOOL-BASED PROJECTS
WERE FOCUSED ON CHILDREN WITH
DEVELOPMENTAL DISABILITIES.
THAT I REMEMBER FOR SURE.
AND I DON'T HAVE A HANDLE ON THE
140 PROJECTS RIGHT AWAY TO TELL
YOU THAT BUT I'M CERTAIN SOME OF
THE ADULT PROJECTS ALSO INCLUDED
PERSONS WITH DISABILITIES.
THAT QUESTION WAS, A, ROUTINELY
ASKED SO THE QUESTION CAN BE
ADDRESSED NOW WITH THE DATA HUB,
WITH ANALYTICS, IF THE DATA ARE
THERE.
AT LEAST IN TERMS OF TESTING AND
REPORT OF THEIR OUTCOMES FROM
THE SURVEY.
>> AND JUST TO EMPHASIZE WHEN WE
WERE PUTTING OUT THE FUNDING
OPPORTUNITY ANNOUNCEMENTS WE
CALLED OUT POPULATIONS THAT WE
WERE VERY INTERESTED IN,
INCLUDED WITH DISABILITIES AS
ONE OF THEM.
>> BRUCE, YOU MAY WANT TO
COMMENT ABOUT THE EFFORTS.
>> THIS REALLY EVOLVED AS A
MAJOR QUESTION FOR US.
WOW, THIS IS LIKE A CRUDE
CHEMISTRY SET FROM HIGH SCHOOL
AND YOU MAY HAVE TO COUNT DROPS
AND MAKES THINGS TOGETHER, SO WE
EMBARKED ON A MAJOR, MAJOR
REDESIGN PROCESS ENGAGING MANY,
MANY STAKEHOLDERS, VARIETY OF
DIFFERENT ADVOCACY ORGANIZATIONS
FOR THE BLIND AND FOR COGNITIVE
IMPAIRMENTS, AND EVEN HAVE NOW
PUBLISHED, YOU CAN GET IT ON OUR
WEBSITE, A GUIDE, REFERENCE
GUIDE FOR THE DESIGN OF
POINT-OF-CARE TECHNOLOGIES, WHAT
CONSIDERATION ALSO SHOULD BE
TAKEN INTO ACCOUNT, AS YOU
DESIGN AND BUILD THESE TO
ADDRESS A WIDE RANGE OF
DISABILITIES SO WE WORKED WITH
BOTH FEDERAL AS WELL AS PRIVATE
ORGANIZATIONS, REDESIGN SHOPS,
SEVERAL NEW TESTS HAVE ALREADY
COME OUT THAT ARE SUPER SIMPLE,
LIKE YOU JUST UNSCREW SOMETHING,
SWAB AND SCREW BACK TOGETHER.
CHECK THE WEBSITE FOR DESIGN
GUIDELINES EXTENDING BEYOND
INFECTIOUS DISEASE TEST.
THE CORE HAS HUMAN FACTORS BAKED
INTO EVERYTHING BEING EVALUATED.
>> I HAVE HOWARD AND THEN BRIAN.
>> CONGRATULATIONS ON THIS GREAT
PROGRESS, TO THE ENTIRE TEAM.
A LOT OF THE PROGRESS WAS MADE
BY EARLY PHASE OF THE PANDEMIC,
SHARE PURPOSE, PARTICLE NEED,
MAKES SENSE NOW THAT YOU'RE
MOVING TO, FOR EXAMPLE,
DIFFERENT COVID VARIANTS OF LONG
COVID.
GOING FORWARD HOW ARE YOU
THINKING ABOUT HARNESSING FOR
DIFFERENT APPLICATIONS?
DR. BERTAGNOLLI YESTERDAY TOLD
US ABOUT THE CANCER MOONSHOT,
EARLY DETECTION OF CANCER PRE-IN
A -- PRE-MALIGNANCY.
IS IT TOP DOWN OR BOTTOM UP, HOW
ARE YOU THINKING ABOUT THIS?
>> SO, I CAN START.
THERE ARE TWO AREAS FOR SURE FOR
US WILL CONTINUE.
ONE IS THE WHOLE RESEARCH
STRATEGY APPROACH PLATFORM OF
COMMUNITY ENGAGED RESEARCH
WITHOUT URGENCY OF WE HAVE A
PUBLIC HEALTH CRISIS PANDEMIC.
YOU MAY HAVE HEARD ABOUT THE
COMMUNITY ENGAGEMENT ALLIANCE
ALLIANCE WHICH WE STOOD UP
SEPARATELY BUT IT'S RELATED.
THE WHOLE IDEA OF PERSISTENT
COMMITMENT AS AN INFRASTRUCTURE
FOR DOING RESEARCH IS SOMETHING
THAT WE'RE COMMITTED TO.
FORTUNATELY PARTNERING WITH
NATIONAL HEART LUNG BLOOD
INSTITUTE, WE'RE INVOLVED IN
OTHER AREAS.
WE'RE PIVOTING CEAL TO OTHER
AREAS.
WHAT WE LEARNED FROM RADx
INFORMING THAT AND WHAT CAN WE
PRESERVE FROM RADX-UP IS FOCUSED
ON DATA REPOSITORY,
COORDINATION.
THEY DID MORE THAN COLLECT DATA
AND DEPOSITED IT.
THEY COORDINATED ALL THESE
GROUPS, HOW THAT INVOLVES NIMHD,
TO CONVINCE OTHERS TO JOIN US.
THE COMMON DATA ELEMENTS, IN
2018 WE SAID WE NEED COMMON DATA
ELEMENTS ON SOCIAL DETERMINANTS
OF HEALTH, EVERY INVESTIGATOR IN
MY SCIENTIFIC COMMUNITY DIDN'T
LIKE THE WAY THE QUESTION WAS
PHRASED SO THEY ASKED THEIR WAY.
CONSTANT.
I DID THAT MYSELF PROBABLY.
WE SAID WE NEED TO ACCEPT
STANDARDIZED WAYS TO DO IT,
EVERYBODY SHOULD DO IT THE SAME
WAY.
WE HAD AN OPPORTUNITY TO DO THAT
AND TEST IT WITH 100+ PROJECTS.
80% OF THEM MORE OR LESS DID IT.
THERE WERE ALWAYS GOING TO BE
OUTLIERS, SO I THINK THAT WAS A
HUGE IMPACT ON HOW WE SEE AT
LEAST IN THE NEAR FUTURE IN
RESEARCH IN MINORITY HEALTH,
HEALTH DISPARITIES, PARTICULARLY
RELATED TO SOCIAL, BEHAVIOR,
POPULATION MEASURES, WITH
LINKING TO CLINICAL ONES.
IT'S A BIG ISSUE IN CLINICAL
RECORDS AS WELL BECAUSE WHERE WE
WOULD LIKE TO BE, I'M A GENERAL
INTERNIST, WE'RE FAR FROM BEING
THERE, SOME SIMILAR ISSUES ARE
FACING.
SO THAT'S MY LESSON.
>> WE'RE AT TIME BUT BRIAN,
LET'S LET YOU HAVE THE LAST WORD
PLEASE.
>> WELL, BUILDING OFF WHAT
ELISEO SAID ABOUT JOINING THE
CEAL INITIATIVE, IT'S A
TRANS-NIH ISSUE OF COMMUNITY
ENGAGEMENT, AS A TYPE OF
SCIENTIFIC INFRASTRUCTURE AND
THE SAME WAY A PIECE OF
LABORATORY EQUIPMENT IS
INFRASTRUCTURE AND YOU CAN'T
BUILD THOSE IN THE MIDDLE OF A
CRISIS.
YOU HAVE TO HAVE THEM IN PLACE.
I WAS IN CHICAGO SEEING RADx
WHERE WE GOT ON THE PHONE WITH
FQH PARTNERS, WOULD YOU HELP
TEST, YEAH, WE WORKED WITH YOU
FOR YEARS, RADX-UP, ALL
PREDICATED ON EXISTING
RELATIONSHIPS.
IT'S NOT CONFINED TO A SINGLE
DISEASE.
IT'S TRANS-INSTITUTE.
RELATIONSHIPS ARE SO KEY SO
ENCOURAGING BUILDING,
SUSTAINING, SUPPORTING.
AND A SCIENCE QUESTION WITH 142
PROJECTS WHAT DO WE KNOW ABOUT
RELATIONSHIPS BEFORE THIS
INITIATIVE STARTED, HOW LONG DID
INVESTIGATORS AND ORGANIZATIONS
WORK TOGETHER, WHAT DID THEY DO
DURING THE COURSE OF THE STUDY
AND WHAT CHARACTERISTICS PREDICT
GREATER SUCCESS BECAUSE WE NEED
TO ALSO GROW THE SCIENCE OF
COMMUNITY ENGAGEMENT, RIGHT?
WHAT DID WE LEARN ABOUT TYPES OF
PARTNERSHIPS, DO YOU HAVE TO
KNOW EACH OTHER FIRST BEFORE
YOU'RE READY TO GO, DO YOU HAVE
MOUs IN PLACE?
HOW DO YOU BUILD TRUST?
I'D LOVE TO SEE SCIENCE
HAPPENING IN WHAT THOSE
RELATIONSHIPS LOOK LIKE AND HOW
IT PREDICTED SUCCESS.
>> THANK YOU FOR THAT.
I WILL TELL YOU THAT ACROSS ALL
OF THE IC CENTERS AND OFFERSES,
INSTITUTE CENTERS AND OFFICES,
WE'VE BEEN TALKING ABOUT THIS
ISSUE, GETTING DEEPLY INTO
COMMUNITIES NOT WITH ONE-TIME
PROJECTS LIKE COVID EPIDEMIC BUT
A CONTINUAL SUSTAINABLE STREAM
OF RESEARCH THAT ENGAGES, MEETS
SPECIFIC NEEDS OF THE COMMUNITY,
AND, YOU KNOW, IT'S CONTINUALLY
ONGOING, WORKING TOGETHER TO
BUILD THAT INFRASTRUCTURE,
PROBABLY COORDINATING AND
COALESCING SOME EXISTING
PROGRAMS BECAUSE WE'RE KNOW
READY TO DO THIS FOR NOW.
AND SO YOU HIT ON SOMETHING
WE'RE GOING TO TRY TO SEE HOW WE
CAN EXECUTE NIH-WIDE.
THANKS.
>> NOW DR. LYRIC JORGENSON,
UPDATE ON NEXTRAC.
>> THE CONVERSATIONS LED
BEAUTIFULLY TO WHAT WE'RE
TALKING ABOUT IN A QUICK UPDATE
BEFORE LUNCH.
WE'RE EXCITED TO TALK ABOUT WHAT
THE NEXTRAC IS WORKING ON.
BUILDING TRANSPARENCY, TRUST,
CLINICAL RESEARCH, THAT'S WHAT
WE'VE BEEN TALKING ABOUT TODAY.
IMPORTANTLY, RECENTLY NIH
LAUNCHED THIS NEW EFFORT TO
DEVELOP A HARMONIZED AND
IMPLEMENTABLE VISION FOR A
FRAMEWORK INCLUDING PUBLIC
VOICES IN CLINICAL RESEARCH.
SPECIFICALLY THE NIH DIRECTOR'S
NOVEL COMMITTEE WAS CHARGED TO
DEVELOP THIS FRAMEWORK.
IN BRIEF, MEMBERS HAVE VAST
EXPERTISE IN EMERGING
TECHNOLOGY, FUTURE OF PATIENT
AND COMMUNITY ENGAGEMENT IN
RESEARCH.
INCREASINGLY SEE USE OF NOVEL
AND EMERGING TECHNOLOGY SUCH AS
THE ONES WE TALKED ABOUT TODAY,
A.I., M.L., DIGITAL HEALTH,
ELECTRONIC HEALTH AND MORE,
DESIGN AND CONDUCT OF CLINICAL
RESEARCH AND WE BELIEVE IT'S
IMPORTANT TO ENGAGE COMMUNITIES
AND PATIENT PARTNERS AND GENERAL
PUBLIC TO HOW AND WHEN DIFFERENT
TYPES OF ENGAGEMENT STRATEGIES
ARE EFFECTIVE AND WHEN THEY WORK
FAST.
ALONG THESE LINES NEXTRAC
COMPLETED AN EFFORT RELATED TO
PUBLIC ENGAGEMENT AROUND DATA
SCIENCE, USING EMERGING
TECHNOLOGY TO THINK ABOUT DATA
SCIENCE.
THIS BUILDS ON THAT EFFORT IN
THE CLINICAL RESEARCH VEIN.
ENGAGING THE PUBLIC IN CLINICAL
RESEARCH WITH THE ACDC, GIVING
YOUR EXPERTISE AND LEADERSHIP OF
THESE ISSUES.
ULTIMATELY, EFFORT IS TO BUILD A
TOOL KIT FOR RESEARCHERS AND THE
COMMUNITY IN TANDEM ABOUT LOU TO
APPROACH THIS INTERESTING AND
IMPORTANT TOPIC.
WE HAVE A LARGE WORKING GROUP,
EXCELLENT CO-CHAIRS LEADING THE
EFFORT.
DR. SUSAN BOTKIN, WHO SERVED ON
THE RECENT DATA SCIENCE AND
EMERGING TECH WORKING GROUP,
PROFESSOR OF SCHOOL OF NURSING,
PROFESSOR OF BIOMEDICAL
INFORMATICS AT COLUMBIA.
SHE'S ALSO HAD EXPERIENCE WITH
PATIENT ENGAGEMENT AND RESEARCH
AND REDUCING HEALTH DISPARITIES.
WE ALSO HAVE A FANTASTIC
CO-CHAIR, REPRESENTED IN PINK,
CHRISTIN VEASLEY, CHRONIC PAIN
RESEARCH ALLIANCE, IN FEDERAL
AGENCIES AND COLLABORATIVE
ALLIANCES TO PROMOTE
PUBLIC/PRIVATE PARTNERSHIPS.
SHE'S BEEN A PASSIONATE ADVOCATE
OF HAVING PATIENT VOICINGS IN
THE DESIGN OF CLINICAL RESEARCH
STUDIES AND EXECUTION.
YOU CAN SEE WE HAVE 22 OTHER
MEMBERS, PATIENTS, PATIENT
ADVOCATES, REPRESENTING CANCER,
RARE DISEASE, SICKLE CELL, DOWN
SYNDROME, AND MORE, ACADEMICS
WITH EXPERTISE RANGING FROM THE
CLINICAL RESEARCH COMMUNITY,
ENGAGEMENT, HEALTH DISPARITIES,
TRIBAL HEALTH AND MORE.
WE'RE ALSO THRILLED YOU'LL SEE
IN GREEN TWO ACD MEMBERS, DR.
KIMBALL AND DR. DIAZ BRINTON.
I WON'T SPEND A LOT OF TIME.
WE HAVE A LARGE INVESTMENT IN
CLINICAL RESEARCH, OFTEN THE
PLACE WHERE PEOPLE RECOGNIZE
WHAT THE NIH DOES AND WHAT
RESEARCH FOR THE PUBLIC, THE
PART WHERE PUBLIC IS MOST
DIRECTLY ENGAGED IN SCIENCE.
NIH RECOGNIZES NEED TO EXPAND
MORE BROADLY, YOU HEARD ABOUT
THIS TODAY.
A RECENT EFFORT AROUND A TASK
FORCE TO KEEP BOLSTERING
ENTERPRISE, GETTING READY FOR
DR. BERTAGNOLLI'S PRIORITIES HAS
LAID THE GROUND WORK AND
LEVERAGING THIS INVESTMENT.
NIH EMPLOYEES A BROAD SPECTRUM,
HARNESSING DIGITAL TECHNOLOGY,
REAL WORLD DATA, AT THE HEART OF
THE WORK IT CAN ONLY BE DONE
WITH DEDICATED MEMBERS OF THE
PUBLIC WHO VOLUNTEER TIME, DATA,
ACTUAL PARTS OF THEMSELVES TO
MAKE THIS SUCCESSFUL, AT THE
HARD - HEART OF HOW WE HAVE
THESE CONVERSATIONS.
WE LAUNCHED RECENTLY.
DR. TABAK ON AUGUST 29, IN
TANDEM WITH RECEIPT OF DATA
SCIENCE RECOMMENDATIONS,
LAUNCHED THIS NEW EFFORT
REGARDING ENGAGING RESEARCH
PARTICIPANTS AND THE COMMUNITY
EARLY AND OFTEN THROUGHOUT THE
RESEARCH CYCLE.
THIS IS SOMETHING AGAIN
LAUNCHED, JUST STARTING OFF,
GETTING THIS MOVING FORWARD.
YOU ALREADY HEARD TODAY THAT WE
DON'T NEED TO REINVENT THE
WHEEL.
MANY PROGRAMS AND PEOPLE HAVE
BEEN PIONEERING THIS IMPORTANT
WORK.
WE TALKED ABOUT SCIENCE OF
UNDERSTANDING, WHAT WORKS AND
WHEN, TAKE EXAMPLES FROM THESE
INITIATIVES TO MOVE
EVIDENCE-BASED APPROACH FORWARD
FOR THE TIMING AND WHAT WORKED
WELL.
WHAT WE LEARNED, WHAT YOU HEARD
TODAY, YOU KNOW IT'S
COMPLICATED.
MEANINGFUL ENGAGEMENT IS NOT
JUST HAVING ONE CONVERSATION AND
LEAVING THE ROOM.
IT REQUIRES RESOURCES, DEDICATED
INFRASTRUCTURE, EXPERTISE OF
THOSE COMMUNITIES AND COMMUNITY
NEEDS, AND COMMITMENT,
BIDIRECTIONAL EXPECTATION AND
HOLDING OURSELVES ACCOUNTABILITY
TO THEM.
THERE WILL NOT BE A
ONE-SIZE-FITS-ALL APPROACH.
THE GOAL OF THIS EFFORT IS
REALLY TO THINK ABOUT A MENU OF
OPTIONS THAT ARE MOST E
EFFECTIVE FOR THE TYPE OF STUDY.
DIFFERENT METHODS MAY DEPEND ON
THE COMMUNITY.
YOU NEED LOCAL ORGANIZERS TO
NAVIGATE THESE ISSUES.
THERE MAY BE VARIABILITY AND
OPTIMAL TIMING AND REALLY A
TAILORED APPROACH TO ENSURE
WE'RE THINKING ABOUT
EQUITABILITY, INCLUSIVITY,
DEPLOYMENT OF THESE APPROACHES.
THE VISION, ONE WE WANT TO HAVE
A PUBLIC TRANSPARENT UNIFIED
AGENDA FOR HOW NIH APPROACHES
PUBLIC ENGAGEMENT.
WE STRUGGLED WITH THE
TERMINOLOGY, COMMUNITY
ENGAGEMENT, PATIENT ENGAGEMENT,
INDIVIDUAL?
IT'S ALL OF THE ABOVE UNDER THE
RUBRIC OF PUBLIC BUT MORE
ENCOMPASSING, THE GOAL FOR A
TOOL KIT, FIRST DEFINING WHAT
OPPORTUNITIES AND CHALLENGES ARE
AND SETTING BASELINE LEVELS OF
EXPECTATIONS FOR PEOPLE WHO
DON'T KNOW HOW BUT WE CAN START
CAN LEVEL PLAYING FIELD.
THINKING ABOUT CONSIDERATION OF
TRADEOFF, GOLD STANDARD TO
ENGAGE ALL THE TIME EARLY,
OFTEN, ALONG THE WAY, REAL
TRADEOFFS IN TERMS OF NOT ONLY
INFRASTRUCTURE AND TIME FOR
RESEARCHERS BUT TIME FOR
PATIENTS AND PARENTS PARTS WHO
CAN'T COME TO MEETINGS FROM NINE
TO FIVE BECAUSE THEY HAVE JOBS,
WE NEED TO COME IN WAYS
MEANINGFUL FOR THEM.
IMPACT OF COMMUNITIES, THINKING
ABOUT THE FINDINGS TO DIVERSE
COMMUNITIES, METHODS OF BUILDING
TRUST TO IMPROVE ADOPTION OF
EVIDENCE-BASED PRACTICES, WE
TALKED TODAY ABOUT RETURN OF
RESULTS AND THINGS MEANINGFUL TO
COMMUNITIES.
POTENTIAL OUTCOMES, NOT ONLY
FOR RESEARCHERS, THERE'S A
BETTER UPTAKE FOR SCIENCE,
INCREASED REPRESENTATION,
UNDERSTANDING OF FACTORS THAT
AFFECT SUCCESSFUL STUDY DESIGN
AND COMPLETION, FOR PARTICIPANTS
UNDERSTAND HOW TO INTERACT IN
RESEARCH, HOW IT'S VALUABLE FOR
THEM, WHAT IT MEANS TO THEIR
COMMUNITIES.
AND OF COURSE THE PUBLIC.
THINKING ABOUT A ROAD MAP FOR
BUILDING AND BRINGING PEOPLE
ALONG THE JOURNEY WITH US AS WE
HEARD FROM THE CEAL INITIATIVE
TO BUILD TRUST IN SCIENCE AND
RESEARCH.
THE TIMELINE, I'M MOVING
QUICKLY, THE WORKING GROUP WAS
ESTABLISHED IN AUGUST.
IT WILL BE A TWO-YEAR PROCESS.
WE NEED TO THINK ABOUT WHAT WE
LEARNED AND DELIVER A PROCESS
THAT WORKS ON THEIR TIME LINE.
OVER THE NEXT TWO YEARS THIS
GROUP THINKING ABOUT HOW TO DO
THIS WELL.
AND PRESENT THE FINDINGS IN
SUMMER OF 2025.
I'D LOVE TO TURN IT OVER TO
ALEXA IN THREE MINUTES TO WEIGH
IN AND OPEN FOR DISCUSSION.
>> TERRIFIC.
CAN YOU HEAR ME OKAY?
>> YES.
>> PERFECT.
SO WE'VE HAD SEVERAL MEETINGS,
LEVEL OF ENGAGEMENT, BACKGROUND,
INFORMATION THAT'S BEING
PROVIDED, SYNTHESIS, IMPORTANTLY
AS YOU'VE HEARD IT'S COMPLICATED
BUT YOU CAN ALSO SEE THAT
ALREADY THIS IS COMING, THE
FRAMEWORK IN WHICH TO THINK
THROUGH THESE PROBLEMS IS
EMERGING AND THAT'S GOING TO
ALLOW US TO BE VERY ACTION
ORIENTED AS WE GO THROUGH.
DESPITE THE FACT THE TIMELINE
PUSHES TO 2025 THE WORK SO THAT
ARE IS ACCELERATED, AND FAST
PACED.
AND I THINK THAT'S IN
PREPARATION FOR THE INTENSE
PUBLIC OUTREACH THAT WE'RE
ANTICIPATING.
HUGE KUDOS TO LYRIC AND TEAM ON
THIS.
I'M REALLY EXCITED WITH HOW THIS
IS GOING.
>> THANK YOU, ALEXA.
>> OKAY, OPEN FOR QUESTIONS.
>> THANK YOU FOR THE
PRESENTATION, VERY IMPORTANT
WORK.
YOU MENTIONED SOMETHING WHICH IS
THE ISSUE BY NATURE RESEARCH IS
ALMOST DISCONTINUOUS, YOU KNOW,
DISCRETE LIKE I'VE SEEN IT AGAIN
AND AGAIN WHERE THERE'S
ESTABLISHMENT OF VERY SOLID DEEP
RELATIONSHIPS WITH COMMUNITIES
BUT THEN THE STUDY ENDS, AND I
HEAR AGAIN AND AGAIN FROM THE
COMMUNITIES THAT WE WORKED IN,
WHERE ARE YOU, WHAT HAPPENED?
IT'S A MAJOR ISSUE.
THERE MAY BE MODELS HOW THIS CAN
BE DONE BUT I FEEL LIKE FOCUSING
ON THE ISSUE OF RESEARCH ENDS,
THERE'S A GAP, SCRAMBLING TO GET
FUNDS TO GO BACK TO THE
COMMUNITY, CAUSING DISTRESS AND
AGAIN DOESN'T PROMOTE SENSE OF
TRUST.
I FEEL LIKE THAT IS AN AREA THAT
MIGHT BE INTERESTING TO JUST
FOCUS ON IN THE DELIBERATIONS.
THANK YOU.
>> NOT TO MENTION WE HAVE GOOD
EVIDENCE THAT SHOWS THAT
COMMUNITIES THAT ARE
PARTICIPATING IN RESEARCH DO
BETTER.
BEING ABLE TO BRING RESEARCH TO
COMMUNITIES HAVING CHALLENGES
ABOUT OUTCOMES, IF WE DO IT IN A
WAY THAT'S NOT HELICOPTER
RESEARCH BUT SUSTAINED IN THE
COMMUNITY THAT'S ABSOLUTELY THE
GOAL.
THAT'S ONE OF THE REASONS WHY WE
APPRECIATE THIS WORKING GROUP,
I'LL SAY WE'VE GOT A LOT GOING
ON.
THAT'S DOING THIS.
SO, THEIR JOB IS REALLY -- YOU
SAW ALREADY TODAY, ALL OF US IS
DOING SOME OF THIS, CEAL IS
DOING SOME OF THIS.
WE'VE GOT SO MUCH GOING ON IN A
PATCHWORK PATTERN, BRINGING IT
TOGETHER IS WHAT'S GOING TO BE A
LOT OF THE FOCUS OF THIS GROUP,
AND WHERE MY FOCUS IS.
>> I'M SORRY.
>> RESEARCH NETWORK, HIV
RESEARCH NETWORK, MANY OTHER
NETWORKS ARE DOING THIS SO I
THINK THERE'S AN OPPORTUNITY.
>> THANK YOU.
LUCILA?
>> YEAH, I WANT TO ALSO AGREE
WITH THAT AND SAY THAT THE PANEL
YOU ASSEMBLE IS AMAZING.
YOU HAVE NAMES THERE THAT I'M
SURE WILL CONTRIBUTE A LOT.
IN TERMS OF CLINICAL TRIALS AND
WE'VE SEEN THAT COHORT STUDIES
SUCH AS THE "ALL OF US" THIS
MORNING, UNDERSTANDING THAT IN
THE BEGINNING AT LEAST IT COSTS
MORE TO ENGAGE, TRULY ENGAGE
CERTAIN COMMUNITIES, I THINK
IMAGINING THE FUNDING FOR
RESEARCH TO PAIR WITH THAT, WITH
THAT GOAL, WOULD BE AN IMPORTANT
ITEM FOR DISCUSSION.
>> THANK YOU.
COMMUNITY LEADERS EMPHASIZED
THAT POINT TO US.
IT'S SOMETHING WE'RE PAYING
GREAT ATTENTION TO.
OTHER COMMENTS OR QUESTIONS THAT
PEOPLE HAVE?
OH, YES, THE BLOOD GLUCOSE
LEVELS, BRUCE WOULD BE
MONITORING BLOOD GLUCOSE LEVELS
GOING DOWN, DOWN, DOWN.
OKAY.
THEN BACK TO YOU, MONICA.
>> THANK YOU VERY MUCH.
I THINK -- THANKS, LYRIC.
I THINK WE'RE DUE A LUNCH BREAK
HERE.
AND WE WILL RECONVENE AT 1:15.
SEE YOU ALL THEN.
[LUNCH RECESS]
>> WE'LL RECONVENE FOR THE FINAL
SESSION OF THE DAY, THE BEST FOR
LAST, DR. SHELLEY BERGER ON THE
LINE, UNIVERSITY OF PENN, AND
DR. TARA SCHWETZ, REENVISIONS
POSTDOCTORAL TRAINING.
I DON'T THINK THERE COULD BE A
BETTER TIME TO HEAR SOMETHING
LIKE THAT.
THANK YOU BOTH.
>> KICKING OFF LIVE FROM CAIRO.
>> I JUST GOT TO MY HOTEL.
FORGIVE ME IF I'M DISJOINTED.
BUT I WANT TO START BY THANKING
DR. BERTAGNOLLI.
IT'S A PLEASURE TO MEET YOU, IF
ONLY VIRTUALLY, AND TO THANK YOU
FOR GIVING TARA SCHWETZ AND ME
THE OPPORTUNITY TO PRESENT THE
RECOMMENDATIONS OF THE WORKING
GROUP.
WE WANT TO THANK THE ACD.
WE DID WORK, AND I HOPE THAT
WILL COME CLEAR AS WE PRESENT
THE RECOMMENDATIONS, ET CETERA.
I'M GOING TO REVIEW THE
BACKGROUND, THE CHARGE, THE DATA
COLLECTED, COMMUNITY FEEDBACK
AND GUIDING PRINCIPLES THAT WE
DEVELOPED.
SOME OF THIS WAS PRESENTED IN
JUNE SO I'M GOING TO BE BRIEF AT
THE BEGINNING BECAUSE TARA WILL
TAKE OVER TO GO THROUGH OUR
RECOMMENDATIONS, AND THERE'S A
LOT OF PEOPLE OUT THERE THAT ARE
CURIOUS ABOUT THAT.
WE'LL GET TO THAT AS QUICKLY AS
POSSIBLE.
SO, SLIDE 2, I'LL JUST START
WITH WHAT BROUGHT US HERE.
THESE MULTI-SECTORIAL AND
COMPLEX FORCES DRIVING THEI.
ON THE LEFT ECONOMIC FACTORS,
INCREASES IN COST OF LIVING,
NEED FOR BETTER BENEFITS.
GEOPOLITICAL FACTORS SUCH AS
COVID AND IMMIGRATION ISSUES
THAT HAVE COME UP THROUGH COVID,
AND EVEN BEFORE, CONCERNS ABOUT
QUALITY OF LIFE AND DESIRE FOR
BETTER WORK/LIFE BALANCE, AND
THEN ON THE RIGHT SIDE LIMITED
ACADEMIC OPPORTUNITIES
CONTRASTING WITH NEW
OPPORTUNITIES IN PHARMA AND
BIOTECH, THE LENGTHENING,
EVER-LENGTHING TIME TO PUBLISH
AND EVER-EXPANDING RESEARCH
EXPECTATIONS WITH GROWTH OF
AMAZING TECHNOLOGIES AND ACCESS,
ACCESS TO THEM.
SO, MANY OF THESE CHALLENGES ARE
BEING FACED OF COURSE NOT ONLY
BY POSTDOCS, BY ALL EARLY CAREER
INVESTIGATORS.
THE IMPACT IS BROAD THROUGH THE
SYSTEM.
POTENTIALLY, YOU KNOW, REALLY
HAVING AN ADVERSE EFFECT ON U.S.
COMPETITIVENESS, RESEARCH,
TRANSLATION TO CLINIC, WHAT
MOTIVATED ME IN WANTING TO
ADDRESS ALL THESE PROBLEMS, THIS
COMBINED CONCERN OF THE
CHALLENGES TO POSTDOCS AND THE
POTENTIAL IMPACT ON U.S.
COMPETITIVENESS.
REALLY WANT TO UNDERLINE BOTH OF
THOSE THINGS.
SO WHILE NIH HAS MADE PROGRESS
BY IMPLEMENTING RECOMMENDATIONS
FROM PREVIOUS ACD WORKING GROUPS
ON THIS TOPIC, MAJOR CHANGES WE
LEAVE ARE STILL NEEDED AND SO
OUR GROUP RESOLVED TO BOLDLY
ADDRESS THE CHALLENGES TO
REENVISION THE ENTERPRISE TO
BETTER BENEFIT AT ALL THESE
LEVELS THAT IMPACT POSTDOCS,
WITH HOPE TO AMELIORATE SYSTEMIC
CONCERNS.
OUR INTENTION WAS TO BALANCE
PROFESSIONAL AND CAREER
DEVELOPMENT RESOURCES TO
POSTDOCS AND THE ENVIRONMENT IN
WHICH THEY OPERATE INCLUDING
MENTORING.
ALTHOUGH WE'VE EXTENSIVELY
DISCUSSED A BROADLY PERCEIVED
DECLINE IN POSTDOCS, CHALLENGES
IN HIRING WHICH ARE BROADLY
BEING FELT WE FELT THESE ISSUES
ARE SYMPTOMS OF A NEED TO
IMPROVE THE HEALTH OF THE
SYSTEM.
SO ACKNOWLEDGE UP FRONT THAT
SOME OF OUR RECOMMENDED CHANGES
MAY LEAD TO FEWER POSTDOCS, NOT
MORE, BUT WE BELIEVE WILL LEAD
TO A HEALTHIER SYSTEM AND THUS
WITH THE HOPE TO BOLSTER THE
ACADEMIC BIOMEDICAL RESEARCH
ENTERPRISE WHICH ALSO OF COURSE
IMPACTS INDUSTRY.
SO, THIS WAS OUR CHARGE BY DR.
TABAK WHEN WE INITIATED THE
WORKING GROUP.
NEXT SLIDE.
IT WAS INTENTIONALLY -- THESE
WERE WRITTEN TO BE QUITE BROAD,
TO EVALUATE EVIDENCE ON THE
PERCEIVED DECLINE OF POSTDOCS,
SEEKING -- Ph.D.s SEEKING
U.S. POSTDOCS.
AND THIS, THERE'S BEEN ANECDOTAL
DISCUSSIONS, WIDESPREAD WITHIN
NIH, OUTSIDE, AND WITH
INSTITUTIONAL LEADERS SUCH AS
HHMI THAT REALLY SUGGEST THIS
TREND WILL CONTINUE AND MAY
ACCELERATE.
IT'S ALSO A GLOBAL CHALLENGE,
WE'VE HEARD THIS PRETTY MUCH
EVERYWHERE.
AND SO SECOND WE WANTED TO
ASSESS AND CONSIDER FACTORS
INFLUENCING THE SCOPE AND
PERSISTENCE OF THE ISSUE.
HERE ACQUIRING DATA FROM MANY
SOURCES, I'LL MENTION THOSE IN A
MINUTE, SORRY, NOT YET.
NOT YET GOING ON.
WE WANTED TO -- HERE WE GO.
WE WANTED TO REVIEW AND COMPARE
OTHER APPROACHES TO POSTDOC
TRAINING, FOR EXAMPLE FROM OTHER
DISCIPLINES.
WE WANTED TO CONSIDER WAYS TO
SUPPORT THE QUALITY OF LIFE,
WORK/LIFE BALANCE, TO INCREASE
RETENTION.
AND WE WANTED TO ENGAGE KEY
INTERNAL AND EXTERNAL COMMUNITY
MEMBERS.
SO NEXT SLIDE.
THESE WERE OUR ACTIVITIES.
YOU CAN READ THROUGH THOSE
QUICKLY.
NEXT SLIDE.
I'M GOING TO SPEAK FIRST ABOUT
REVIEWING THE DATA.
WE REVIEWED, YOU KNOW, QUITE A
LOT OF DATA FROM VARIOUS SOURCES
TO GET A BETTER SENSE OF THE
CURRENT LANDSCAPE.
NEXT SLIDE.
SO, WE REVIEWED THE AVAILABLE
DATA ON POSTDOC TRENDS, AND WE
WENT TO SEVERAL SOURCES
INCLUDING INTERNAL NIH SOURCES
AND NATIONAL POSTDOC
ASSOCIATION, ALONG WITH SURVEY
DATA IN THE SECOND PART FROM THE
NATIONAL SCIENCE FOUNDATION AND
"NATURE," THEY PROVIDED A LOT,
AND OTHERS.
WE'RE THANKING ALL OF THESE
GROUPS THAT HAVE BEEN WILLING TO
SHARE THEIR FINDINGS WITH US.
WE'RE NOT GOING TO -- TODAY
WE'RE NOT GOING THROUGH THE DATA
IN DETAIL.
WE DON'T HAVE TIME TODAY.
SO PLEASE REVIEW THESE REPORTS,
EITHER ISSUED OR QUICKLY ISSUED
AFTER THIS MEETING, AND IT'S
POSTED TO THE ACD WEBSITE.
SO I'M GOING TO REVIEW THE
OVERALL FINDINGS QUICKLY.
NOTABLY, THE DATA SHOWED THE
NUMBER OF POSTDOC SCHOLARS HAS
REMAINED LARGELY FAT IN RECENT
YEARS, WITH MORE NOTICEABLE
DECLINE SINCE 2020.
THERE'S BEEN A SIMILAR DECLINE
IN THE NUMBER OF NRSA
APPLICATIONS, SUGGESTING
APPEALING, THERE'S REPORTED
DISSATISFACTION AND CONCERNS
ABOUT THE POSTDOC EXPERIENCES
AND CAREER PROSPECTS GROWING,
AMONG THE POSTDOC POPULATION,
FROM THESE RECENT SURVEYS.
KEY TRENDS, DECREASING NUMBERS
OF PhDs GOING INTO ACADEMIA
WITH INCREASING NUMBERS GOING TO
BUSINESS OR INDUSTRY.
PLEASE READ OUR REPORT.
YOU'LL GET SOME MUCH-EXPANDED
INFORMATION.
WE GATHERED COMMUNITY FEEDBACK,
KEY TO ENGAGE WITH THE
COMMUNITY, ALL THOSE COMMUNITIES
THAT ARE INVOLVED HERE AND ARE
IMPACTED.
SO NEXT SLIDE.
SO, HERE'S A REALLY BROAD
SUMMARY ON SOME OF OUR
ACTIVITIES.
WE HELD PUBLIC VIRTUAL LISTENING
SESSIONS IN MARCH OF THIS YEAR,
2023.
EACH ONE WAS FOCUSED ON A SET OF
SPECIFIC TOPICS.
I'M NOT GOING TO GO THROUGH THEM
OR READ THROUGH THEM.
YOU CAN READ THEM QUICKLY
YOURSELVES.
THESE WERE WIDELY ATTENDED, AS
YOU CAN SEE.
WE RECEIVED THOUGHTFUL REMARKS
FROM INVITED SPEAKERS AND WE
INVITED SPEAKERS AND THEY WERE
EXTREMELY THOUGHTFUL AND DEEP IN
THEIR THINKING.
AND AS WELL AS AT-LARGE
PARTICIPANTS, GAVE THEM A CHANCE
TO TALK.
RECORDINGS AND SLIDES ARE
AVAILABLE ON THE WORKING GROUP
WEBSITE AND A FULL SUMMARY
REPORT.
SO, THE REPORT OUTLINES THREE
CROSS-CUTTING THEMES THAT WE
CAME TO FROM THESE.
THERE IS A NEED TO MITIGATE
FINANCIAL STRAIN AND AMBIGUITY
IN JOB STATUS, NEED FOR
INCREASED SUPPORT, FINANCIAL AND
MENTORING FOR TRANSITIONING TO
THE NEXT CAREER STAGE, WHETHER
ACADEMIC OR MANY OTHER CAREER
TRAJECTORIES.
THERE'S A NEED TO ADDRESS POWER
IMBALANCES BETWEEN POSTDOC AND
MENTORS THROUGH BETTER
ACCOUNTABILITY AND OVERSIGHT OF
INSTITUTIONS AND MENTORS AND A
FOCUS ON TREATMENT OF VULNERABLE
GROUPS INCLUDING INTERNATIONAL
POSTDOCS.
THERE'S A BROAD SENSE WE
PERCEIVED IN LISTENING GROUPS
MANY POSTDOCS FEEL UNDERVALUED
AND WITH LOW RESPECT.
SO NEXT SLIDE.
WE THEN HAD A REQUEST FOR
INFORMATION.
WE OFFERED A VERY BROAD
OPPORTUNITY TO PROVIDE FORMAL
FEEDBACK THROUGH THIS MECHANISM.
AND HERE WE HAD HUGE ENGAGEMENT,
ABOUT 3300 RESPONSES MOSTLY FROM
INDIVIDUALS AND ACADEMIC
AFFILIATIONS ABOUT HALF FROM
POSTDOCS, 15% FROM GRADUATE
STUDENTS, AND 21% COME BINDS
FACULTY, EARLY-STAGE
INVESTIGATORS, REMAINDER
INDUSTRY, ADMINISTRATORS,
ADVOCATES, ET CETERA.
SO THE RESPONDENTS PROVIDED
FEEDBACK ON PERSPECTIVES ON
ROLES AND RESPONSIBILITIES,
FUNDAMENTAL CHALLENGES,
POTENTIAL SOLUTIONS.
WE HEARD A LOT OF GREAT IDEAS
ACTUALLY THAT HAVE BEEN
INCORPORATED IN THE FINAL
RECOMMENDATIONS.
I WANT TO NOTE COMPENSATION WAS
MENTIONED IN 89% OF THE
RESPONSES LEADING TO OUR FIRST
RECOMMENDATION AS YOU'LL SEE.
OTHER AREAS OF FOCUS WERE CAREER
PROSPECTS, SATISFACTION, JOB
SECURITY, QUALITY OF LIFE,
WORK/LIFE BALANCE, DEIA ISSUES
AND HARASSMENT, MENTORSHIP,
INTERNATIONAL CONCERNS, AND
OTHERS.
AND SO THE SUGGESTIONS FOR
SOLUTIONS WERE SHARED INCLUDING
IDEAS LIKE STANDARDIZING TITLE,
SALARIES, BENEFITS ACROSS THE
BOARD; BUILDING COHORTS WITHIN
COMMUNITIES; MENTORING TRAINING
FOR POSTDOCS AND P.I.s.
THE FULL ANALYSIS ON THE ACDC
WEBSITE.
WHAT WE HEARD ACROSS LISTENING
SESSIONS AND RFI WERE MAJOR, NOT
MEETING THE NEEDS.
MOST CONTINUE TO FIND ACADEMIC
RESEARCH AND TRAINING REWARDING
AND HAVING ATTRACTIVE
FLEXIBILITY, BUT THERE IS THIS
OVERARCHING SYSTEMIC ISSUES.
COMPENSATION AND BENEFITS
OVERARCHING, OVERPAID AND
OVERWORKED, KEY TO THEIR
EDUCATIONAL LEVEL AND
EXPERIENCE, PAY AND BENEFITS
OFTEN ARE FELT TO BE
INCONSISTENT WITHIN AND ACROSS
INSTITUTIONS, ESPECIALLY WITH
RESPECT TO VARIOUS FUNDING
SOURCES.
s INTERNATIONAL POSTDOCS ARE
CRITICAL COMPONENT OF THE U.S.
POSTDOC WORK FORCE THAT
EXPERIENCE UNIQUE
VULNERABILITIES, FOR EXAMPLE
VISA ISSUES.
THERE WAS EMPHATIC CALL FOR
EXPAND RESEARCH IN ACADEMIA,
STAFF SCIENTIST POSITION, CAREER
SCIENTISTS IN ACADEMIA, NOT ON
TENURE TRACK TOWARD FULL
PROFESSOR OR SENIOR
INVESTIGATOR.
AGAIN, MANY FIND THE ACADEMIC
ENVIRONMENT REWARDING BUT THE
CAREER PATH REQUIRES MORE
PROFESSIONALISM, RESPECT,
COMPENSATION.
THERE'S A STRONG EMPHASIS AND
NEED FOR PROFESSIONAL
DEVELOPMENT.
STRONG FEEDBACK THAT SOME
CONSIDER TRAINING TERMINOLOGY
DISCREDITS THE POSTDOC AND SO
YOU'LL HEAR IN A SECOND A
DISCUSSION TO CHANGE THE
TERMINOLOGY TO POSTDOC SCHOLARS.
THESE ARE TERMS, WORDS, TITLES,
BUT THEY DO HAVE IMPACT.
WE ALL KNOW THAT.
THERE WERE REQUESTS FOR A CHANGE
IN CULTURE, INCLUDING AS I SAID
BEFORE INCREASED RECOGNITION AND
COMMUNITY BUILDING.
A SENSE THAT THE SYSTEM DOES NOT
FULLY APPRECIATE OR COMPENSATE.
THE KEY CONTRIBUTIONS OF
POSTDOCS TO THE ACADEMIC
ENTERPRISE.
OKAY.
AND WE ALSO FELT THAT THERE
OUGHT TO BE -- WE HEARD THERE
SHOULD BE SUPPORT FOR INCREASED
ACCOUNTABILITY AND OVERSIGHT, OF
POSTDOC MENTORS, TO COME BACK
POWER IMBALANCES, VERY SPECIFIC
CALLS, WE HEARD, FOR BETTER
TRAINING FOR MENTORS AND
SELF-GUIDED CAREER DEVELOPMENT
FOR POSTDOC SCHOLARS.
AND YOU'LL HEAR THAT A LITTLE
BIT AGAIN.
NOW I'LL JUST QUICKLY GO OVER
THE GUIDING PRINCIPLES THAT WE
DEVELOPED INITIALLY AND THOSE
FED INTO OUR RECOMMENDATIONS.
IN DEVELOPING THESE, IN ADDITION
TO THE BROAD COMMUNITY
ENGAGEMENT, WE HAD CRUCIAL
ADDITIONAL INPUT INCLUDING
TARGETED CONSULTATION WITH
EXPERTS, SUCH AS EXPERT SPEAKERS
DURING A LISTENING SESSION, WE
HAD NUMEROUS INSTITUTIONAL
RESPONSES TO THE RFA.
WE CONSULTED WITH EXPERT GROUPS,
WE INVITED GUESTS FROM NSF AND
NATURE TO REVIEW DATA AND WE
ESPECIALLY TARA PRESENTED ABOUT
OUR, YOU KNOW, OUR PROGRESS TO
RELATED GROUPS SUCH AS THE
HEALTH RESEARCH ALLIANCE,
NATIONAL BUREAU OF ECONOMIC
RESEARCH, AND HEADS OF
INTERNATIONAL RESEARCH
ORGANIZATIONS.
HERE IS OUR WORKING GROUP GOAL.
AS DISCUSSED PREVIOUSLY, THE
GROUP FEELS STRONGLY THAT
EFFORTS SHOULD AIM TO IMPROVE
THE HEALTH OF THE ENTIRE SYSTEM
BEYOND CURRENT CONCERNS ABOUT
DECLINE IN SUPPLY.
IMPORTANTLY, TO ENSURE THAT THE
U.S. BIOMEDICINE, THE ENTIRE
ENTERPRISE REMAINS COMPETITIVE.
WE WANTED TO ESTABLISH BOLD
ASPIRATIONS, TO HAVE -- CONVEY
SENSE OF URGENCY AND THESE
SYSTEM LEVEL PROBLEMS REQUIRE
SYSTEM LEVEL SOLUTIONS.
SO WE MET A LOT.
WE ENGAGED A LOT.
WE PROVIDED TIME AND PLENTIFUL
INTERACTIONS AMONG US TO ALLOW
SOLUTIONS TO EMERGE.
A LOT OF MEETING, TALKING, AND
THAT WAS FUN AND EXCITING TO DO.
SO, WE DECIDED TO PROVIDE A NEW
DEFINITION OF POSTDOC, SHOWN
HERE, AN INDIVIDUAL WHO HAS
RECEIVED A DOCTORAL DEGREE OR
EQUIVALENT TO PREPARE FOR AN
INDEPENDENT CAREER USUALLY IN
RESEARCH AND TEACHING.
NOW, EACH -- THIS IS A CHANGE
FROM THE PREVIOUS DEFINITION
THAT'S ON THE NIH WEBSITE.
I DON'T WANT -- WE DON'T HAVE
TIME TO GO THROUGH THIS IN
DETAIL, THE DIFFERENT ELEMENTS,
SO EACH ELEMENT HERE, EACH
PHRASE HAS A SPECIFIC INTENT SO
PLEASE CONSULT THE REPORT FOR
THE DETAILS.
OKAY.
IMPORTANTLY, POSTDOC HERE AT THE
BOTTOM IS NOT ONLY A TRAINEE.
THE WORKING GROUP ADVOCATES FOR
USE OF POSTDOCTORAL SCHOLAR TO
BE USED TO REFLECT BOTH THE HIGH
LEVEL OF EXPERTISE THAT POSTDOCS
HAVE AND THE RESPECT THEIR
POSITION DESERVES.
WE REALLY UNDERLINE THAT.
OKAY.
SO, LET'S QUICKLY GO THROUGH THE
GUIDING PRINCIPLES.
THESE ARE NOT PRIORITIZED, NOT
IN ANY PARTICULAR ORDER.
TAKEN TOGETHER, THEY LED TO OUR
SIX RECOMMENDATIONS.
IT'S NOT A ONE FOR ONE, GUIDING
PRINCIPLES KIND OF -- YOU KNOW,
LED TO THE ENTIRE SPECTRUM OF
RECOMMENDATIONS.
SO, ONE, ALL POSTDOCTORAL
SCHOLARS SHOULD RECEIVE A WAGE
WITH REGULAR COST OF LIVING
ADJUSTMENTS, EMPLOYEE LEVEL
BENEFITS COMMENSURATE WITH
EDUCATION AND TRAINING
REGARDLESS OF THE NIH SUPPORT
MECHANISM OR APPOINTMENT AT THE
INSTITUTION.
WE HAVE A STRONG SENSE AND
WITHIN OURSELVES AND FROM PUBLIC
FEEDBACK THIS PRINCIPLE IS KEY
AND NON-NEGOTIABLE.
WE FEEL THIS IS KEY, CRUCIAL, TO
PROVIDE A BETTER EXPERIENCE FOR
POSTDOCS AND HEALTHIER SYSTEM
OVERALL AND I KEEP SAYING THIS,
TO PROTECT THE U.S. BIOMEDICAL
COMPETITIVENESS.
PRINCIPLE 2, SCHOLARS SHOULD BE
WELCOMING INTO A SAFE AND
SUPPORTIVE WORK ENVIRONMENT FREE
FROM ABUSE, DISCRIMINATION,
HARASSMENT.
OF COURSE, THIS IS EMERGING IN
MANY OTHER WORKING GROUP AND
OTHER AREAS OF THE NIH.
PRINCIPLE 3 POSITION SHOULD BE
CLEARLY DEFINED, STANDARDIZED,
TRACKED WITHIN AND ACROSS
INSTITUTIONS, DISCIPLINES,
FUNDING MECHANISMS.
THE DURATION OF THE POSITION
SHOULD BE CAPPED AT A FINITE
NUMBER OF YEARS.
PRINCIPLE 4, NEW OR EXPANDED
FUNDING MECHANISMS SUCH AS K99,
R00, WITH RESOURCES INCLUDING --
AND WE WERE INTERESTED IN
DEVELOPING, VERY STRONG INTEREST
IN INCREASED NUMBER OF
PROFESSIONAL STAFF SCIENTISTS
WITH RECOMMENDATIONS FOR
INCREASED GRANT SUPPORT.
BOTH TO PROVIDE A CAREER PATH
FOR THOSE WISHING TO REMAIN IN
ACADEMIC RESEARCH AS
PROFESSIONALS, AND TO HELP TOE
STABILIZE THE BIOMEDICAL
RESEARCH INFRASTRUCTURE.
PRINCIPLE 5 INTERNATIONAL POST
DOC SCHOLARS SHOULD HAVE SALARY
AND BENEFITS EQUAL TO INCIDENCE
AND PERMANENT RESIDENTS WITH
ACCESS TO MORE FEDERAL GRANT
TRUANTS.
AS A KEYNOTE, THIS GROUP
COMPRISES MORE THAN HALF THE
POSTDOCTORAL WORKFORCE AND
CONTRIBUTE DISPROPORTIONATELY TO
U.S. INNOVATION AND
ENTREPRENEURSHIP, AND LOSS OF
THIS TALENT WOULD SERIOUSLY
REDUCE U.S. COMPETITIVENESS AND
DIMINISH RICHNESS OF IDEAS IN
RESEARCH IN OUR COUNTRY.
THIS PRINCIPLE WAS CRUCIAL AND
INTEGRATED ACROSS ALL
RECOMMENDATIONS.
SIX, PROFESSIONAL AND CAREER
DEVELOPMENT SHOULD GO AN
INTEGRAL MEASURED COMPONENT OF
THE POSTDOCTORAL EXPERIENCE AND
OCCUPY A MINIMUM PERCENTAGE OF
THE POSTDOCTORAL SCHOLAR'S TIME,
MANY POSTDOCS COME INTO THE
POSITION STILL SEEKING
ADDITIONAL PROFESSIONAL
INSTRUCTION.
PRINCIPLE 7, INSTITUTION,
PROGRAM, PRINCIPAL INVESTIGATORS
SHOULD BE HELD ACCOUNTABLE FOR
QUALITY MENTORSHIP AND
PROFESSIONAL DEVELOPMENT
OPPORTUNITIES.
TRAINING AND MENTORING SKILLS
SHOULD BE PROMOTED FOR THOSE WHO
SERVE IN A MENTOR ROLE OR WORK
AS LEADERS IN POSTDOCTORAL
OFFICES, AND CRITICALLY FOR THE
POSTDOCTORAL SCHOLARS
THEMSELVES, SO THIS WAS A
WIDESPREAD CONCERN FROM THE
LISTENING GROUPS AND REQUEST FOR
INFORMATION.
THIS INCLUDES MENTORING FOR
POSTDOCTORAL MENTORS, AND
INSTRUCTION TO THE SCHOLARS HOW
TO MENTOR.
SO THAT'S IT ON THE BEGINNING.
I'M GOING TO TURN IT OVER TO
TARA FOR THE RECOMMENDATIONS.
>> THANKS, SHELLEY.
I GET THE FUN JOB GOING THROUGH
THE RECOMMENDATIONS WHICH,
AGAIN, THERE WAS A LOT OF TIME
AND DISCUSSION THAT WENT INTO
HOW TO FRAME THE
RECOMMENDATIONS.
BEFORE I GO INTO THESE
SPECIFICALLY I WANT TO NOTE AS
SHELLEY MENTIONED IT'S IMPORTANT
THAT WE REALIZE THE CHANGES THAT
ARE BEING RECOMMENDED ARE GOING
TO REQUIRE SIGNIFICANT RESOURCES
AND COMMITMENT NOT JUST FROM NIH
BUT BROADER BIOMEDICAL COMMUNITY
AND BELIEVE SHE'S WILL LEAD TO
IMPROVED HEALTH OF THE ECOSYSTEM
AS A WHOLE.
AND WE ACKNOWLEDGE THIS MAY
RESULT IN FEWER POSTDOCS THAT
ARE BEING SUPPORTED.
SO, THE SEVEN GUIDING PRINCIPLES
SHE OUTLINED HELPED TO ALIGN AND
INFORM SIX RECOMMENDATIONS WE
PUT TOGETHER.
THESE RECOMMENDATIONS INCLUDE
INCREASING PAY AND BENEFITS FOR
ALL NIH-SUPPORTED POSTDOCTORAL
SCHOLARS.
CREATING AND EXPANDING
MECHANISMS FOR SUPPORTING THE
FULL TALENT POOL OF POSTDOCTORAL
SCHOOL ASHES.
HELPING TO FACILITATE TRANSITION
OF THESE FOLKS INTO THEIR NEXT
CAREER STAGE, THAT INCLUDES
THROUGH ROLES THAT GO BEYOND
ACADEMIC FACULTY POSITIONS.
RECOMMENDATION 4, PROMOTING AND
DEVELOPING PROFESSIONAL AND
CAREER DEVELOPMENT OF
POSTDOCTORAL SCHOLARS BUT
IMPORTANTLY OF THEIR MENTORS
ALSO.
FIFTH IS SUPPORTING SAFE AND
DIVERSE PERSPECTIVE AND RESEARCH
ENVIRONMENT WITHIN INSTITUTIONAL
RESEARCH PROGRAMS.
AND FINALLY, WE NEED WAYS TO
IMPROVE THE MEANS IN WHICH WE
MEASURE AND SHARE DATA ABOUT THE
POSTDOCTORAL SCHOLARS TO HELP US
INFORM FUTURE DECISION MAKING.
AND I WANT TO ALSO RECOGNIZE THE
IMPORTANCE AS SHELLEY MENTIONED
THROUGHOUT OF INTERNATIONAL
POSTDOCTORAL SCHOLARS, SUCH A
CRITICAL COMPONENT.
WE INTEGRATED IDEAS THAT OUR
ADDRESSING THE SPECIFIC NEEDS OF
THIS COHORT THROUGHOUT ALL OF
THESE RECOMMENDATIONS.
SO, BEFORE WE GO INTO THE ACTUAL
DETAILS OF EACH OF THE
RECOMMENDATION IS WANT TO SAY A
NOTE ABOUT THE TIMELINES BECAUSE
WE WANTED TO POINT OUT THESE
RECOMMENDATIONS CAN BE THOUGHT
OF BASED ON TIMELINE WE
PRAGMATICALLY BELIEVE THEY COULD
BE IMPLEMENTED.
AND WE HAVE MADE RECOMMENDATIONS
THROUGHOUT THE REPORT TO REFLECT
THAT.
BUT MANY RECOMMENDATIONS
ACTUALLY HAVE COMPONENTS OF BOTH
SHORT-TERM IDEAS, THINGS THAT
COULD HAPPEN IN THE NEXT YEAR OR
TWO, AS WELL AS LONGER--TERM
IDEAS, MORE COMPLICATED, WILL
TAKE A LITTLE BIT TO WORK
THROUGH THE DETAILS ON.
AND SO WITH THAT SAID, I'LL JUMP
RIGHT IN TO THE FIRST
RECOMMENDATION.
SO, RECOMMENDATION 1 IS TO
INCREASE PAY AND BENEFITS OF
NIH-SUPPORTED POSTDOCTORAL
SCHOLARS.
WE STRONGLY BELIEVE THAT THIS IS
THE TOP RECOMMENDATION.
IF THERE WAS ONLY ONE
RECOMMENDATION THAT NIH COULD
IMPLEMENT, THIS SHOULD BE IT.
SO, NIH SHOULD INCREASE SALARY
ANNUALLY ADJUSTED TO INFLATION,
INCLUDING MINIMUM OF $70,000 FOR
NRSA STIPEND IN 2024.
RECOGNIZE THAT WE'RE IN 2024
BASICALLY, IT'S THE END OF 2023.
THIS MAY BE A BIT DIFFICULT TO
DO BECAUSE OF TIMING PURPOSES,
AS WELL AS SIGNIFICANT RESOURCE
NEEDS THIS WILL HAVE AND
DIFFICULT DECISIONS THAT MAY
NEED TO BE MADE.
WE WANT TO RECOGNIZE THE
CONSEQUENCES OF INCREASING
POSTDOCTORAL PAY WITHOUT
CORRESPONDING INCREASE IN NIH
BUDGET, WE KNOW THE BUDGET YEAR
IS GOING TO BE TIGHT FOR FISCAL
YEAR 24, WE DON'T HAVE IT YET
AND WE'RE IN DECEMBER, MAY MEAN
THERE'S A REDUCTION IN NUMBER OF
POSTDOCTORAL POSITIONS THAT NIH
CAN SUPPORT.
THE WORKING GROUP VIEWS THIS AS
THIS OUTCOME AS A MEANS TO
ENHANCE THE QUALITY AND EFFICACY
OF POSTDOCTORAL TRAINING.
WE WANT TO STREAMLINE THE CAREER
PATH TO THE NEXT CAREER STAGE
AND ENSURE THOSE WHO ARE
EMBARKING ON A POSTDOCTORAL
POSITION ARE DOING SO THROUGH A
MEANS THEY ARE FEELING
ADEQUATELY COMPENSATED.
SO WE EXPECT THE SIZE OF THE
POSTDOCTORAL WORKFORCE WILL
LIKELY REEQUILIBRATE OVER TIME
AT A LEVEL NEEDED TO SUPPORT
ROBUST AND APPROPRIATELY AGAIN
COMPENSATED AND SUPPORTED
POSTDOCTORAL POPULATION.
WHILE WE MENTION NRSA, SHOULD BE
APPLICABLE TO ALL POSTDOCS.
ONE THING WE SAW IN THE SURVEYS
AND LISTENING SESSIONS AND RFI
WAS THAT THERE IS A SIGNIFICANT
AMOUNT OF VARIABILITY,
PARTICULARLY WITH PAY, WITHIN
DEPARTMENT, LABS WITHIN
INDIVIDUAL UNIVERSITIES.
THIS IS ALSO TRUE OF BENEFITS.
BECAUSE POSTDOCS ON NRSAs ARE
TREATED DIFFERENTLY THAN R01, WE
FEEL IT'S IMPORTANT TO
STANDARDIZE AND ENSURING
EVERYONE IS RECEIVING MINIMUM
FLESH HOLD OF BENEFIT.
OUR RECOMMENDATION IS TO PROVIDE
FULL-TIME EMPLOYEE LEVEL
BENEFITS FOR ALL NIH-SUPPORTED
POSTDOCTORAL SCHOLARS.
THAT SHOULD INCLUDE FULL-TIME
BENEFITS, HEALTH, VISION, DENTAL
COVERAGE, AT THE MINIMUM.
AND THEN WE ALSO FOCUSED A BIT
ON DEPEND CARE BECAUSE THE GROUP
THINKS NIH SUPPORT FOR THIS
SHOULD BE EXPANDED AND WE KNOW
THIS DISPROPORTIONATELY IMPACTS
WOMEN.
WE WANT TO RECOGNIZE THAT
DIFFERENT INSTITUTIONS HAVE
DIFFERENT DEFINITIONS OF THE
MEANING OF EMPLOYEE LEVEL
BENEFIT.
WITH THIS STATEMENT WE DO NOT
GET SORT OF TOO DIRECTIVE IN THE
DETAILS SO WE WANT TO PROVIDE
SOME FLEXIBILITY THERE BUT MAKE
SURE SOMEONE IN THE SAME LAB
RECEIVES THE SAME LEVEL OF
BENEFIT AS THEIR LAB MATE
REGARDLESS OF THEIR FUNDING
SUPPORT.
MOVING ON TO THE NEXT PART OF
THIS RECOMMENDATION, THE GROUP
FELT STRONGLY THAT A POSTDOC
SHOULD NOT BE ENDURING.
IT SHOULDN'T BE A CAREER
POSITION.
AND THERE SHOULDN'T BE ANYONE
WHO SPENT OVER A DECADE AS A
POSTDOC, FOR INSTANCE.
AT A POINT IT BECOMES A CAREER
POSITION AND NOT A POSTDOC
POSITION.
WE RECOMMEND POSITIONS LAST NO
LONGER THAN FIVE YEARS
REGARDLESS OF THE INSTITUTIONS
THEY ARE AT.
WE BELIEVE SOMEONE SHOULDN'T BE
A POSTDOC FOR FOUR YEARS AT ONE
INSTITUTION AND MOVE TO ANOTHER
ONE AND BE A POSTDOC FOR THREE
YEARS.
COMBINED TOTAL SHOULD ONLY BE
FIVE YEARS.
A HUGE PART OF THIS IS TO SHIFT
TO TRANSITIONING POSTDOCS INTO
THESE LONGER-TERM CAREER
POSITIONS, THAT ARE MORE
SUSTAINABLE.
AND SHELLEY DEFINED DEFINITION
OF A POSTDOC PREVIOUSLY SO I
WON'T DO THAT BUT WE HOPE THAT
THIS WILL HELP TO LIMIT GAMING,
SHIFTING PEOPLE INTO POSITIONS
THAT ARE POSTDOCS IN ALL BUT
NAME.
WE RECOGNIZE AT TIMES THERE ARE
LEGITIMATE REASONS THAT PEOPLE
NEED TO STAY FOR LONGER THAN
FIVE YEARS, THERE SHOULD BE OF
COURSE EXTENSION PROVIDED TO
FOLKS BECAUSE THERE'S
SIGNIFICANT LIFE EVENTS, BIRTH
OF A CHILD, AND CIRCUMSTANCES
THAT EXTEND THAT.
WE THINK ABOUT OUR SECOND
RECOMMENDATION, WHICH WAS
CREATING AN EXPANDING MECHANISM
TO SUPPORT THE FULL TALENT POOL
OF POSTDOCTORAL SCHOLARS,
WORKING GROUP RECOGNIZED
SOMETIMES THE REASON PEOPLE ARE
IN THESE REALLY LONG POSTDOC
POSITIONS BECAUSE THEY I CAN'T
FIND A JOB OR NEED MORE TIME TO
FIND A JOB.
ONE OF THE THINGS WE WANTED TO
FOCUS ON WAS FACILITATING THAT
TRANSITION, WE COULD EXPAND
MECHANISMINGS TO RECRUIT AND
RETAIN THE TALENT POOL SHIFTING
INTO THE NEXT POSITION.
WE PROPOSE A VARIETY OF THINGS
INCLUDING DEVELOPING NEW AND
EXPANDED K MECHANISMS, AT
INSTITUTIONAL LEVEL AND
INDIVIDUAL LEVEL, TO RECRUIT AND
RETAIN SCHOLARS.
OPENNESS MORE BROADLY SO THAT
THOSE WHO ARE INTERNATIONAL
POSTDOCS HAVE MORE OPTIONS THAT
ARE AVAILABLE TO THEM SINCE THEY
ARE NOT ELIGIBLE FOR NRSA.
WE DISCUSSED NEW K12-LIKE AWARDS
TO SUPPORT COHORTS OF DIVERSE
POSTDOCS AS WELL AS ESTABLISH
NEW AWARDS FOR THOSE AT
UNIVERSITIES WITHOUT
INSTITUTIONAL AWARDS.
WE PROPOSE TO REVISE K99/R00
MECHANISM, QUITE SUCCESSFUL, BUT
WE WANTED TO FOCUS ON IDEAS AND
CREATIVITY OVER PRODUCTIVITY.
THIS COULD INCLUDE LIMITING
ELIGIBILITY WINDOW FOR THE FIRST
TWO YEARS OF THE POSTDOC TO
ENSURE THE DURATION OF THE
POSTDOC IS REASONABLE.
ADAPTING PROCESS AND POLICIES,
PILOTING A NEW TRANSITION AWARD
MECHANISM FOLLOWING THE ONE FROM
GRAD SCHOOL, POSTDOC, INTO THE
FIRST FACULTY POSITION, SO AN
F99/K00/ROO TYPE OF AWARD AS AN
IDEA.
FINALLY FOR THE LAST PART OF
RECOMMENDATION 2, WE PROPOSE TO
CREATE AND EXPAND THE MECHANISMS
FOR SUPPORT FOR INTERNATIONAL
SCHOLARS SINCE THERE'S A
CRITICAL COMPONENT OF THE
WORKFORCE.
WE THINK IT'S INCUMBENT UPON NIH
TO EXPAND ELIGIBILITY TO INCLUDE
INTERNATIONAL POSTDOCS WHERE
IT'S LEGALLY FEASIBLE.
SO WE RECOGNIZE, FOR EXAMPLE,
THAT SOME PROGRAMS THAT WERE
AIMED ALTAR GETTING THOSE IN
IDEA STATES WON'T BE APPLICABLE
BUT WANT TO BROADLY RECOGNIZE
CRITICAL ROLE THESE FOLKS PLAY
IN THE ECOSYSTEM DEVELOPING
TARGETED MECHANISMS TO SUPPORT
INTERNATIONAL TALENT.
MANY RESPONDED FROM THE RFI AND
LISTENING SESSIONS,
IMMIGRATION-RELATED ISSUES WERE
A CHALLENGE AND CUMBERSOME.
NIH DOESN'T CONTROL THESE, IT'S
OUTSIDE THE SCOPE OF THE WORK OF
OUR AGENCY, BUT THE WORKING
GROUP RECOMMENDED THAT NIH
PROVIDE SUPPORT FOR
IMMIGRATION-RELATED ISSUES THAT
COULD BE THROUGH THINGS LIKE
EXPANDING OUT THE CONTRACT THAT
POSTDOCS ARE ON FROM ONE YEAR,
THREE YEARS.
CONVERSATIONS WITH RELEVANT
AGENTS TO MAKE THEM AWARE OF
ISSUES THAT THE POSTDOCS ARE
FACING.
RECOMMENDATION 3, WE FELT THAT
THE -- THE GROUP FELT
FUNDAMENTAL GOAL IS TO RECEIVE
TRAINING AND CAREER DEVELOPMENT,
TRANSITION TO A PERMANENT CAREER
POSITION.
SO, TO FACILITATE THAT WE
RECOMMENDED THAT NIH INCREASE
SUPPORT FOR A RESEARCH
PROFESSIONAL TRACK WITH CLEAR
EXPECTATION AND CERTAIN LEVEL OF
CULTURAL STANDING OR RESPECT,
THIS WOULD BE A VALID POSITION
PEOPLE COULD GO INTO.
IT COULD BE IN THE FORM OF A
CAREER SCIENTIST SOMETHING,
STAFF SCIENTIST POSITION, BUT TO
SUPPORT DIFFERENT CAREER PATHS
THAT WE KNOW PEOPLE ARE ALREADY
SHIFTING INTO.
CREATING PILOT PROGRAMS, POLICY,
BUSINESS, INDUSTRY, OTHER FIELDS
COULD BE INCLUDED.
WE RECOGNIZE AGAIN MOST ARE NOT
COMMITTING TO ACADEMIC
POSITIONS.
AND SO WE THINK IT'S IMPORTANT
TO CREATE AND FACILITATE
ENGAGEMENT WITH A BROAD RANGE OF
FACTORS THAT HIRE POSTDOCS, THEY
NEED PATIENT ADVOCACY GROUPS,
NON-PROFITS, INDUSTRY,
GOVERNMENT, PROFESSIONAL
SOCIETIES, MANY OTHERS.
THIS COULD LEAD NIH TO EXPLORING
NOVEL COLLABORATIVE AND
PARTNERSHIP PATHWAYS TO
SUPPORTING POSTDOCS.
FOR RECOMMENDATION 4, THE FOCUS
IS ON PROMOTING THE TRAINING AND
PROFESSIONAL DEVELOPMENT OF
SCHOLARS AND MENTORS.
WE BELIEVE IT'S A STAPLE AND
CORE TENANT OF POSTDOC YOU GET
THAT EXPERIENCE.
AND SO THIS SHOULD BE ENHANCED
THROUGH PROMOTING CAREER AND
PROFESSIONAL DEVELOPMENT THAT
OCCUPIES 10% MINIMUM OF TIME OR
EFFORT.
WE THOUGHT THIS SHOULDN'T APPLY
ONLY TO THE POSTDOCS.
ALSO TO THE MENTORS WHO SHOULD
BE ABLE TO PROMOTE THE SKILLS
AND EXPERIENCES OF THEIR
POSTDOCS.
WHILE THE INDIVIDUAL SHOULD BE
ABLE TO SELECT THE TYPE OF
TRAINING THEY WISH TO
PARTICIPATE IN BASED ON THEIR
INTERESTS, INSTITUTIONS ALSO
SHARE A DEGREE OF RESPONSIBILITY
HERE TO BE ABLE TO PROVIDE SOME
OF THESE RESOURCES TO SUPPORT
THEM THROUGH A VARIETY OF
DIFFERENT COURSE OR EXPERIENTIAL
OFFERINGS.
WE ALSO THOUGHT IT WOULD BE
PRUDENT TO TRY TO LEVERAGE THE
INFRASTRUCTURE THAT COULD BE
BUILT ACROSS THE U.S. SO THAT
THOSE INSTITUTIONS WHO DON'T
NECESSARILY HAVE RESOURCES TO BE
ABLE TO DEVELOP A BUNCH OF
PROGRAMS COULD SORT OF SHARE
THIS ACROSS THE BOARD.
AND OF COURSE THIS RELIES ON A
CERTAIN LEVEL OF ACCOUNTABILITY
FOR MENTORS TO BE ABLE TO -- TO
BE ABLE AND WILLING TO SUPPORT
THEIR POSTDOCS.
AND ONE WAY WE TALKED ABOUT THIS
WAS TO BE TRACKED OR MEASURED
AND DOING THIS IS PART OF THEIR
RPPRs, OR POSSIBLY MISSION OF
A MENTORSHIP PLAN WHEN THEY ARE
DEVELOPING GRANT APPLICATIONS.
AND WE THOUGHT NIH COULD
CONSIDER WAYS TO RECOGNIZE
OUTSTANDING MENTORS, TO HELP
PROMOTE THIS AS A KEY COMPONENT
OF TRAINING.
WITH OUR FIFTH RECOMMENDATION,
PENULTIMATE RECOMMENDATION, THE
WORKING GROUP FOCUSED ON THE
NEED TO SUPPORT AND FACILITATE A
SAFE ENVIRONMENT FREE FROM
HARASSMENT.
AND ADDRESS SOME POWER BALANCE
OF IMBALANCE SHELLEY MENTIONED,
TO CONTINUE TO ENSURE ACT OF
ACCOUNTABILITY OF P.I.s AND
INSTITUTIONS AS WE KNOW THOSE
PEOPLE ARE THE MOST VULNERABLE
TO FEELING TARGETED AND/OR
HARASSED.
IT'S IMPORTANT THE INSTITUTIONS
FEEL EMPOWERED TO FOSTER DIVERSE
PERSPECTIVES, MONITORING
IMPLEMENTATION OF DIFFERENT
RECOMMENDATIONS, PARTICULARLY
RECOMMENDATION 1, TO HAVE THIS
DISPARATE IMPLEMENTATION OF
THESE RECOMMENDATIONS, AND THIS
WILL HELP ENSURE THAT IS
MITIGATED IN SOME RESPECT.
THE GROUP WANTED TO ENDORSE,
MAKE SURE IN THE EFFORTS SUCH AS
UNITE TO SUPPORT DIVERSITY IN
THE WORK FORCE, ENCOURAGES
INSTITUTIONS TO DO THE SAME.
WHILE RECOGNIZING NEEDS OF
INTERNATIONAL POSTDOCS.
AND, AGAIN, NAVIGATING THOSE
COMPLEX IMMIGRATION POLICIES,
WORKING GROUP DID MAKE A
SUGGESTION ABOUT DISSEMINATING
FOR INSTANCE A TRAINING MODULE
ON IMMIGRATION EDUCATION WITH
RESOURCES THAT COULD HELP FOLKS
NAVIGATE IMMIGRATION POLICIES
AND PROCESSES.
FINALLY, COLLECTION AND
STANDARDIZATION OF DATA ARE
MAJOR CHALLENGES THAT LIMIT OUR
ABILITY TO MEASURE AND EVALUATE
SPECIFIC ACTIONS AND PROGRAMS.
SO, THE GROUP FELT STRONGLY THAT
WE NEEDED TO IMPROVE DATA
COLLECTION.
PART COULD BE DONE BY ENHANCING
COLLABORATIONS THAT NIH ALREADY
HAS WITH NSF, COULD THEY COLLECT
A TON OF DATA BOTH
ADMINISTRATIVE WHICH IS
IMPORTANT AND EVEN KNOWING THE
NUMBER OF POSTDOCS THAT EXIST IN
THE COUNTRY, THAT'S NOT EVEN
100% CLEAR.
WE HAVE PRETTY GOOD DATA BUT IF
WE COULD HAVE REALLY GREAT DATA
THAT WOULD BE EVEN BETTER.
BUT ALSO TO COLLECT DATA ON
CAREER OUTCOMES, TO KNOW WHAT
WE'RE DOING IS ACTUALLY HAVING
THE IMPACT WE WANT, WILL HELP
FACILITATE BETTER
IMPLEMENTATION.
TO REQUIRE ALL NIH-FUNDED
POSTDOCTORAL SCHOLARS TO HAVE AN
ERA COME ANSWER ACCOUNT
INDEPENDENT OF INSTITUTION TO
HELP US TRACK OVER THEIR CAREER
DURATION ESPECIALLY IF THEY STAY
IN THE SORT OF NIH SPHERE.
AND ONCE WE HAVE THE DATA AS A
MEANS TO FURTHER GATHER
ADDITIONAL DATA, THE GROUP
BELIEVES COMMUNICATION WITH THE
COMMUNITY, WITH THE POSTDOC,
INSTITUTIONS, PROFESSIONAL
SOCIETIES, ALL ORGANIZATIONS
WILL BE HELPFUL AND VITAL TO
CLARIFY AND DISSEMINATE TO HELP
ALIGN OUR EXPECTATIONS.
ONE MECHANISM DISCUSSED WAS
CREATION OF CENTRALIZED PORTAL,
A ONE-STOP SHOP TO HOUSE ALL
KIND OF INFORMATION, POLICIES,
PRACTICES, NEW UPDATES THAT ARE
COMING THROUGH AND MORE.
AND I THINK IT WILL BE ONE TASK
TO KEEP THAT MULTI-DIRECTIONAL,
BIDIRECTIONAL AT LEAST, DIALOGUE
OPEN TO OPTIMIZE IMPLEMENTATION
AND HOPEFULLY ENSURE SUCCESS.
THE GROUP EMPHASIZED THAT NIH
SHOULD BOLDLY MEET THE NEED FOR
SIGNIFICANT CHANGE TO IMPROVE
CONDITIONS FOR POSTDOCTORAL
SCHOLARS AND ENTIRE ACADEMIC
ENTERPRISE.
RECOGNIZE THAT THERE ARE MANY
INSTANCES AND PORTIONS OF
RECOMMENDATIONS THAT NIH IS NOT
GOING TO BE ABLE TO DO ALONE.
IT'S CRITICAL TO ENGAGE OTHER
GOVERNMENTAL AGENCIES,
ORGANIZATIONS, INSTITUTIONS, KEY
PARTNERS IN SUCCESS.
AND IT CAN'T BE OVERSTATED THAT
CLARIFICATION, SIMPLIFICATION
AND BROAD DISSEMINATION SHOULD
BE STAPLED IN ANY APPROACH TO
IMPLEMENT RECOMMENDATIONS.
PEOPLE DON'T UNDERSTAND POLICIES
OR HAVE DIFFERENT
INTERPRETATIONS, I THINK THAT'S
GOING TO DIMINISH THE UTILITY OF
THESE THINGS.
AND ONLY ACCOMPLISHED THROUGH
THAT ENGAGED, THROUGH THE
BIDIRECTIONAL MULTI-DIRECTIONAL
DIALOGUE PREVIOUSLY MENTIONED.
THE WORKING GROUP BELIEVES THESE
RECOMMENDATIONS WILL RESULT IN
LARGE STEPS FORWARD TO ENSURE
POSTDOCTORAL SCHOLARS ARE --
POSTDOCTORAL POSITIONS ARE
DESIRABLE, COMPETITIVE,
SUSTAINABLE, INCLUSIVE.
AND HOPEFULLY BOLSTER THE
HEALTH, COMPETITIVENESS AND
SUSTAINABILITY THE THE U.S.
RESEARCH ENTERPRISE.
AND SO WITH THAT, WE WANT TO
GIVE A HUGE SHOUT OUT TO THE ACD
POSTDOCTORAL WORKING GROUP.
SHELLEY MENTIONED THIS WAS A LOT
OF WORK GOING INTO THIS.
WE HAVE A REALLY GREAT GROUP
FROM A BROAD RANGE OF SECTORS
AND AREAS, DIFFERENT CAREER
STAGES FROM GRADUATE STUDENTS UP
THROUGH ESTABLISHED P.I.s, YOU
HAVE ACD MEMBER, FORMER ACD
MEMBERS, PEOPLE IN NIH
LEADERSHIP, SOME IN THE ROOM,
AND MANY OTHERS WHO REALLY GAVE
US VALUABLE INSIGHT AND WE
COULDN'T HAVE DONE THIS WITHOUT
THEM.
SHELLEY, DID YOU WANT TO TAKE IT
FROM HERE?
>> I JUST WANT TO ADD MY THANKS.
THE WORKING GROUP WAS ABSOLUTELY
FANTASTIC, REALLY ENGAGED,
EVERYONE SHOWED UP WEEK AFTER
WEEK, MONTH AFTER MONTH.
I ALSO WANT -- TARA DIDN'T SAY
IT BECAUSE IT'S HER HOME CREW
BUT I WANT TO THANK THE NIH EX
OFFICIO MEMBERS.
THEY REALLY PROVIDED GREAT
GROUNDING AND REMINDING US OF
WHAT HAS ALREADY BEEN DONE, WHAT
IS LEGAL, THANK YOU MIKE.
A GREAT GROUP.
I CAN'T THANK EVERYONE ENOUGH
FOR THE EFFORTS.
>> THE EXECUTIVE SECRETARY, ONE
OF WHICH IS IN THE ROOM,
BRITTANY, WAS DOING TWO WORKING
GROUPS THEY SAME TIME.
BRITTANY AND THEN LAURA WHO IS
OVER THERE AS WELL, HUGELY
INSTRUMENTAL IN THIS EFFORT.
WE COULDN'T HAVE DONE IT WITHOUT
THEM.
AND ANOTHER WAS INVOLVED BEFORE
HE SWITCHED TO A NEW ROLE,
SUPPORT AS WELL HELPED US BE
SUCCESSFUL.
WE RECEIVED A LOT OF SUPPORT FOR
THE LARGE NUMBER OF RESPONSES
THROUGH RFI ANALYSIS, A GROUP
ACROSS NIH THAT HELPED ANALYZE
DATA, SPEAKERS, PROVIDE DATA, OF
COURSE WHO CAME BEFORE US THAT
LAID THE FOUNDATION.
WE WERE ABLE TO BUILD OFF OF
THEIR WORK.
FINALLY, ALL THE MEMBERS OF THE
COMMUNITY WHO TOOK THE TIME AND
PROVIDED REALLY THOUGHTFUL
COMMENTS AND FEEDBACK TO US.
WITH THAT WE WILL OPEN UP
QUESTIONS AND DISCUSSION.
>> LET ME GIVE MY THANKS TO
EVERYONE ON THE COMMITTEE, TO
THE TWO OF YOU.
I WANT TO REITERATE SOME THINGS
I SAID YESTERDAY MORNING WHEN WE
FIRST STARTED.
WE MIGHT BE HEADING -- WE ARE
HEADING INTO CHALLENGING TIMES
FINANCIALLY.
IF YOU ASKED ME WHAT IS THE
SINGLE THING THAT KEEPS ME UP
MOST AT NIGHT, AS NEW NIH
DIRECTOR, IT'S THE NEXT
GENERATION AND HOW WE MAKE SURE
THAT WE SUPPORT THEM.
I APPRECIATE THESE EFFORTS AND
LOOKING FORWARD TO YOUR
COMMENTS.
GIVE US ALL YOUR ADVICE HOW TO
DO THIS.
>> OKAY, WE'LL START.
>> MORE OF A COMMENT
HIGHLIGHTING.
IN 1944 THE WORLD WAR WAS ENDING
PRESIDENT ROOSEVELT ASKED FOR A
VISION, HOW WE CAN BUILD AND
SUPPORT SCIENCE IN THIS COUNTRY.
BUSH DELIVERED A VISION, WHICH
OUTLINED A VISION FOR THE NEXT
75 YEARS.
THIS ENTERPRISE WHICH COULD TAKE
HIV AND AIDS AND TURN IT INTO A
CHRONIC ILLNESS, GIVE US A HUMAN
GENOME, TOOLS, AND RECENTLY
DELIVER TREATMENTS FOR SICKLE
CELL DISEASE, GAVE US CAR-T
CELLS FOR CANCER AND THROUGHOUT
THIS 75-YEAR PATH INVESTMENTS
HAVE BEEN MADE TO CONTINUE TO
GIVE PEOPLE RESOURCES.
AND 1998-2003 CLINTON AND
PRESIDENT BUSH OVERSAW WHAT WAS
THE NIH DOUBLING THROUGH THE
WORK OF VARMUS, KIRSCHSTEIN,
THAT FUNDING WENT TO SUPPORT THE
SENIOR MOST SCIENTISTS, REALLY
HELPING MUCH OF THAT PARTS OF
THE WORKFORCE.
IN 2016 REAL CONCERN AROSE,
THROUGH THE 21ST CENTURY CURES
ACT FUNDING WENT TO STUDY HOW TO
SUPPORT YOUNG SCIENTISTS UNDER
PRESIDENT OBAMA.
UNDER PRESIDENT TRUMP AND
THROUGH THE WORK OF FRANCIS
COLLINS, NEXT GENERATION
RESEARCH INITIATIVE WAS
LAUNCHED, GIVING SUPPORT AND
FUNDING TO EARLY CAREER
SCIENTISTS, JUNIOR FACULTY
MEMBERS IN THE SYSTEM,
BUTTRESSING THROUGHOUT THAT
75-YEAR VISION TO 2020.
AND OF COURSE MAIN CHALLENGES
AROSE IN 2020.
IF YOU LOOK, THE NUMBER OF
POSTDOCS DROPPED SHARPLY AT THAT
POINT IN TIME.
IF YOU THINK ABOUT OUR WORK
FORCE ONLY ABOUT HALF IS
ACTUALLY U.S. RESIDENTS.
PERMANENT RESIDENTS OR
INDIVIDUALS WHO ARE CITIZENS
HERE.
AND THERE ARE MAJOR CHALLENGES
THROUGHOUT THE ENTERPRISE
PARTICULARLY GLOBAL COMPETITION.
CLEAR TO US AS A COMMUNITY IF WE
DIDN'T THINK ABOUT THIS PART OF
THE ENTERPRISE, THE ENTIRE PART
OF THE ENTERPRISE WAS AT RISK.
WE'RE GREAT FOLLOW FOR THE
OPPORTUNITY YOU'VE GIVEN US TO
STUDY THIS.
IN THINKING ABOUT THE
IMPLEMENTATION ONE THING THAT
WAS CLEAR HERE, WASN'T UNDER THE
PURVIEW OF THE COMMITTEE BUT
WANT TO BE MINDFUL GIVEN HOW
MUCH YOU RAISED CONCERNS ABOUT
EARLY CAREER INVESTIGATORS AS WE
THINK ABOUT ADDRESSING THE
POSTDOC --
[ NO AUDIO ]
HEARING AND ACCEPTING OUR
REPORT.
CONSIDERING AND ACCEPTING OUR
REPORT.
>> THANK YOU.
OTHER QUESTIONS?
>> COREY, YOU'RE NEXT.
>> THANK YOU FOR A WONDERFUL
REPORT.
I COMMEND THE WORKING GROUP ON
THE REPORT AND ALL THE WORK THAT
WENT INTO DEVELOPING THE
INFORMATION AND RECOMMENDATIONS.
I HAVE ONE QUESTION IN TERMS OF
THE SALARY INCREASE OF THE
THRESHOLD THAT WAS RECOMMENDED.
IN TERMS OF LISTENING SESSIONS,
OUTREACH, TO INFORM
RECOMMENDATIONS, WERE THERE ANY
DISCUSSIONS AROUND HOW AN
INCREASE IN THAT SALARY
THRESHOLD MIGHT IMPACT
UNDERRESOURCED INSTITUTIONS SUCH
AS HBCU IT'S AND
MINORITY-SERVING INSTITUTIONS
WHO MAY NOT HAVE THE LATITUDE TO
REDUCE COSTS TO ACCOUNT FOR
SALARY INCREASES OR MAY NOT HAVE
RESOURCES ON CAMPUS THAT CAN BE
MARSHALED TOWARD LEADING THAT
SALARY THRESHOLD, IN TERMS OF
DIVERSIFYING THE TALENT POOL
THESE SOLUTIONS ARE CRITICAL AND
DOING THAT, AND SO I JUST WOULD
BE INTERESTED IN HEARING ANY
STRATEGIES THAT THE COMMITTEE
CAME UP, IF THIS ACTUALLY AROSE
AS AN ISSUE, ANY STRATEGIES
OFFERED IN TERMS OF ENSURING
THAT THESE INSTITUTIONS ARE
INCLUDED AS A PART OF NIH'S
EARLY CAREER DEVELOPMENT
PIPELINE, IN TERMS OF POSTDOCS
TOWARD DEVELOPMENT BECAUSE
THAT'S CRITICAL FOR EQUITY AND
DIVERSITY.
>> YEAH, I MEAN, ONE OF THE
THINGS THAT I'LL JUST MENTION,
THE GROUP DIDN'T GET INTO
TREMENDOUS AMOUNT OF DETAIL BUT
WE DID TALK ABOUT ENSURING ALL
RECOMMENDATIONS, NOT JUST THIS
ONE, CONSIDERED THE BROAD IMPACT
ON UNIVERSITIES THAT MAY NOT
HAVE LET'S SAY DEEPER POCKETS AS
SOME OF THE OTHERS.
SO, IMMEDIATELY ONE THING THAT
COMES TO MIND WAS AROUND THE
ISSUE OR DISCUSSION AROUND
BENEFITS.
AND SO ONE OF THE THINGS THAT'S
IN THE REPORT THAT'S BEING
PROPOSED IS THAT FOR
INSTITUTIONS THAT MAYBE RECEIVE
AN NIH -- CERTAIN AMOUNT OF NIH
FUNDING, WE WERE SORT OF VAGUE
WITH THAT IN THE REPORT, BUT
THAT THOSE INSTITUTIONS MAYBE
COULD WORK OUT AGREEMENT WHERE
NIH COVERED SAY 50% OF COST FOR
BENEFITS FOR POSTDOCTORAL
SCHOLARS, RECOGNIZE THIS IS
GOING TO BE MAYBE IN PARTICULAR
A DISPROPORTIONATELY IMPACT ON
THOSE UNIVERSITIES BUT THROUGH
THE BENEFIT PIECE AS WELL
BECAUSE THE SALARIES CAN BE
WRITTEN INTO THE GRANT.
IF WE THINK ABOUT IMPLEMENTATION
OVER TIME MAYBE, THAT COULD KIND
OF BE FIGURED OUT IN A WAY THERE
ISN'T AS MUCH OF IMPACT, A
LITTLE BIT OF BUFFER BUT THOSE
BENEFITS ARE GOING TO FALL MORE
SQUARELY ON THE RESPONSIBILITY
OF THE INSTITUTIONS, WE WANTED
TO MAKE SURE WE COULD MITIGATE
THAT.
>> CAN I JOIN IN?
FIRST, YOUR POINT IS WELL TAKEN.
WE'RE ALL COMMITTED TO
SUPPORTING OUR POSTDOCS, AND,
YOU KNOW, THAT'S REALLY CLEAR.
I THINK THAT UNINTENDED
CONSEQUENCES ARE GOING TO HAPPEN
DOWNSTREAM WITH THIS, AND I
DON'T THINK WE CAN FORESEE WHAT
THEY WILL BE.
AND I THINK WE JUST HAVE TO BE
INCREDIBLY MINDFUL OF THAT, VERY
WATCHFUL, AND SEE WHAT HAPPENS,
AND YOU'RE RIGHT, WE NEED A
PLAN.
IF YOU DO GET PART OF WHAT WE
WILL THINK ABOUT THEN IN
EXECUTION IS TO MONITOR CLOSELY
AND DEVELOP MITIGATION PLANS.
IT'S GOING TO HAPPEN SOMEWHERE.
I'M NOT SURE WE KNOW WHERE BUT
THERE'S GOING TO BE HURT WE
CAN'T FULLY ANTICIPATE AND HAVE
TO WHAT WE CAN.
>> A LITTLE SOMETHING TO THAT,
IT'S SHELLEY.
I AGREE WITH THAT
WHOLEHEARTEDLY, AND ANOTHER AREA
THAT WE REALLY DISCUSSED, YOU
KNOW, IN GREAT DETAIL BACK AND
FORTH WAS RECOMMENDATION MAYBE
SOMEBODY'S GOING TO BRING IT UP
ABOUT CHANGING THE K99/ K99/R00
MECHANISM TO TWO YEARS OF
ELIGIBILITY.
ON ONE HAND THAT WOULD SEEM TO
HELP TO LOWER THE FAVORABLE
TREATMENT OF, YOU KNOW, POSTDOCS
COMING IN WITH, YOU KNOW, THE
CNS TYPE PUBLICATIONS.
WE WANT IDEAS.
WE KNOW THAT THERE ARE A LOT OF
ELEMENTS THAT GO INTO HOW
PUBLICATIONS GET ACCEPTED.
IT'S COMPLEX, OF COURSE.
SO WE THOUGHT THIS WOULD HELP
BUT WE ALSO -- WE ALSO
CONSIDERED IT WOULD -- COULD
STILL BACKFIRE AND STILL COULD
FAVOR, YOU KNOW, THE LARGER
RESEARCH INSTITUTIONS.
SO, YOU KNOW, I AGREE THAT THAT
KIND OF THING IS GOING TO HAVE
BE MONITORED CAREFULLY TO SEE --
IT TAKES A WHILE TO FIGURE THAT
OUT SO IT'S GOING TO HAVE TO BE
FOLLOWED CAREFULLY.
>> WE DID THINK ABOUT HOW THIS
MAY IMPACT DIFFERENT
INSTITUTIONS.
WE ALSO THOUGHT ABOUT THE
INDIVIDUALS AT THE INSTITUTIONS.
ONE OF THE THINGS PRETTY CLEAR
IS YOU MIGHT BE ABLE TO TOLERATE
A LOWER SALARY IF YOU'RE COMING
FROM MULTI-GENERATIONAL WEALTH
BUT SMALL TOWN KANSAS OR INNER
CITY DETROIT YOU MAY NOT BE ABLE
TO NAVIGATE AT THE LOWER SALARY.
THIS IS DRIVING PEOPLE OUT OF
POSTDOCS AND ACADEMIA.
WE WANTED TO BE MINDFUL OF
ADDRESSES THAT AS WELL BECAUSE
OTHERWISE IT COMPROMISES GREATER
INTENT OF DRAWING TALENT FROM
MORE PARTS OF THE COUNTRY TO THE
ACADEMIC WORKFORCE.
>> LUCILA, GARTH, HOWARD.
>> I'M ALSO EXCITED ABOUT THIS
REPORT BECAUSE I CAN'T IMAGINE
ANYONE IN THE ROOM NOT BEING
INFLUENCED BY A POSTDOC OR
INFLUENCES THE CAREER OF A
POSTDOC.
IT AFFECTS US ALL, IT'S GREAT TO
ELEVATE THE STATUS.
MY COMMENT SOMEWHAT SMALL,
RELATED TO THE K99.
HAVING MENTORED SEVERAL POSTDOCS
AROUND THAT, THEIR RATE READY TO
SUBMIT IS VARIABLE.
I DO THINK THE FIRST TWO YEARS
WILL FACILITATE FOR THOSE COMING
FROM DOCTORAL DEGREES IN WHICH
THEY ARE PREPARED TO BE READY
FOR THAT AND WILL MAKE IT HARDER
FOR OTHERS.
IT'S NOT JUST LIFE EVENTS BUT
OTHER THINGS HAPPEN THAT SOME
TRAINEES OR POSTDOC SCHOLARS
REQUIRE MORE TIME TO BE MENTORED
TO WRITE THAT K99 AWARD.
TO BE COMPATIBLE WITH FIVE YEARS
MY SUGGESTION PROGRAMS --
PERHAPS ON THE FOURTH YEAR
KNOWING THE K99 WOULD BE
SHORTENED BY ONE YEAR TO FULFILL
THE REQUIREMENTS BUT IN GENERAL
I'M VERY EXCITED ABOUT THIS
REPORT.
THANK YOU.
>> GARTH?
>> YES, A LOT OF QUESTIONS WERE
ANSWERED.
I'M MORE CAUTIOUS THAN MANY
OTHERS IN THE CONVERSATION
BECAUSE OF THE UNINTENDED
CONSEQUENCES THAT WE HAVE
ALLUDED TO HERE AND IMPACTS
PARTICULARLY ON PEOPLE FROM MY
OWN EXPERIENCE, UNDERRESOURCED
BACKGROUNDS, DIFFERENT LIVES.
I WONDER, TWO QUESTIONS, ONE IS
IT WAS MENTIONED THAT WE EXPECT
A LOWER NUMBER OF POSTDOCS GIVEN
SOME DYNAMICS, WONDER IF THERE'S
A GUESSTIMATE AROUND PERCENTAGE
AND THEN KINDS OF PEOPLE THAT
MAY BE IMPACTED BY THOSE OVERALL
PHYSICAL DYNAMICS, AND I DO WANT
TO DELVE INTO THE FIVE-YEAR
CONCEPT, SECOND QUESTION, AGAIN
FOR PEOPLE WHO ARE NOT ALWAYS
THE QUICKEST, I'LL PUT MYSELF
IN THAT CATEGORY, HAVE TO WORK
OR OTHER LITTLE THINGS LIFE
CHALLENGES THAT COME UP,
DIFFERENT POINTS IN YOUR
ACADEMIC CAREER, I JUST WONDER
ABOUT THE FIVE-YEAR LIMIT AND
PRACTICALITY IN THE REAL WORLD.
I WANT TO VOICE THAT CONCERN BUT
MORE GO BACK TO THE FIRST
CONCERN ABOUT, YOU KNOW, THE
NUMBER, POTENTIAL DECREASE IN
OVERALL NUMBER THAT WAS
MENTIONED.
>> SO WE DIDN'T NECESSARILY HONE
IN ON PERCENTAGE THAT WE
EXPECTED FOR DECREASE.
THERE ARE A LOT OF VARIABLES
THAT WILL GO INTO DICTATING
THAT.
HONESTLY, I WOULDN'T SAY -- I
EMPHASIZE THAT'S NOT THE THING
THE GROUP WAS WANTING TO HAPPEN.
I THINK THERE WAS A REALITY
AROUND THE EXPECTATIONS BECAUSE
OF JUST THE STATE OF THE BUDGET
AND WE KNOW THERE ARE PRIORITIES
AND IF YOU HAVE -- TOUGH
DECISIONS.
I MENTIONED PREVIOUSLY THE
SYSTEM WILL REEQUILIBRATE.
IMPORTANT AS YOU POINT OUT TO
MAKE SURE THAT WE ARE TRACKING
THIS TO BE SURE THAT SOME OF THE
UNINTENDED CONSEQUENCES THAT
MONICA MENTIONED EARLIER AND
OTHERS HAVE MENTIONED ARE NOT
HAPPENING, AND IF THEY ARE
HAPPENING HOW WE CAN QUICKLY
PIVOT TO TRY TO ADDRESS THEM.
>> GARTH, I'LL JUST ADD TO THIS
ACTUALLY WE DEBATED EVEN A
SHORTER CAP, SO I'M IN YOUR CAMP
ACTUALLY, THAT THERE'S SO MUCH
VARIABILITY IN THE WAY PEOPLE
COME INTO POSTDOCS, PREPARATION,
THE WAY THEY MATURE THROUGH THE
POSTDOC, YOU KNOW, I LIKE THE
IDEA OF FLEXIBILITY SO I REALLY
COME ON THE SIDE, TARA MENTIONED
IT AT THE END OF THE
RECOMMENDATION, THERE WOULD BE
WAYS TO LENGTHEN, YOU KNOW,
MITIGATING CIRCUMSTANCES OF ALL
SORTS.
I THINK THAT SHOULD BE ON THE
LIBERAL SIDE AS YOU WOULD, YOU
KNOW, I MEAN THE LIBERAL SIDE OF
WHAT THOSE THINGS MIGHT BE THAT
WOULD WARRANT EXTENDING THAT.
SO I AGREE WITH YOU ON THAT FOR
SURE.
AND I THINK THE WORKING GROUP
CERTAINLY DEBATED SMALLER,
LARGER NUMBERS FOR THE CAP.
>> THANK YOU.
HOWARD AND WAFA AND ATOOL.
>> GREAT.
THANK YOU FOR TAKING ON THIS
IMPORTANT TASK, FANTASTIC
REPORT.
IT'S GOING TO IMPACT THE ENTIRE
BIOMEDICAL WORKFORCE.
PROPOSED SALARY SCALE AND
FIVE-YEAR CAP IS A REALITY AT MY
INSTITUTION, THAT HASN'T LEFT
MAJOR UNTOWARD EFFECTS, MAKING
IT A MORE ATTRACTIVE PROPOSITION
IN THIS COMPETITIVE LANDSCAPE.
TWO POINTS, ONE THAT THINKING IF
THAT'S THE CASE OF A SMALLER
GROUP, THE FOLKS WHO MIGHT BE
MOST IMPACTED WILL BE THE NEWEST
INVESTIGATORS EXPECTED TO
SUPPORT INDIVIDUALS AND COMPETE
AMONG SMALLER POOL.
THEY MAY NEVER GET A POSTDOC OR
BE ABLE TO SUPPORT ONE OR HAVE
THAT TRACK RECORD OF MENTORING
ONE.
IF YOU HAVE ZERO TRACK RECORD
THEY ARE GOING TO BE IN THIS
GROUP OR NEVER QUALIFY.
THAT'S A POSSIBLE CONSEQUENCE.
THE SECOND QUESTION IS ABOUT THE
COMMENT ABOUT FOLKS WITH THE
SAME TITLE HAVING THE SAME
SALARY, I ASSUME THE SALARY
LEVEL IS LIKE A SUGGESTED FLOOR
BUT NOT NECESSARILY A CAP.
>> CORRECT.
>> IF SOMEBODY NEGOTIATE BETTER,
SORRY, YOU CANNOT BE PAID MORE.
>> GREAT POINT.
THE ONE STOP SHOP PORTAL, WE
CALLED IT THE MYTH BUSTING
BECAUSE THAT'S ONE OF THE MYTHS
THAT WE HEARD THAT NRSA STIPEND
LEVEL WAS A CEILING AND WHAT
WE'VE SAID OVER AND OVER, NO,
IT'S IT'S A FLOOR.
THAT'S ONE THING WE WOULD
INCLUDE.
THERE'S A LOT VARIABILITY IN
INTERPRETATION OF POLICIES.
>> HOWARD, IT'S A GREAT POINT
AND IT'S COME UP, OTHERS HAVE
MENTIONED IT.
WE'RE CERTAINLY CONCERNED ABOUT
IT.
I DO THINK THAT IF THIS IS GOING
TO AFFECT EVERYONE, NOT JUST
EARLY STAGE, HIGHLY ANECDOTAL
BUT AT MY INSTITUTION POSTDOCS
ARE -- GRADUATES STUDENTS AND
POSTDOCS GRAVITATE TO THE NEW
EXCITING ESI P.I.s.
WE'RE ALL GOING TO SUFFER THE
SAME -- I DON'T WANT TO SAY
SUFFER BECAUSE IT'S GREAT FOR
THE POSTDOCS, BUT THE SAME
DIFFICULTY IN FINANCING THOSE,
THE POSTDOCS.
BUT I'M HOPEFUL THAT IT WON'T
HAVE A DISPROPORTIONATE -- MAYBE
I'M IN THE MINORITY, HOPEFULLY
IT WILL NOT HAVE A
DISPROPORTIONATE EFFECT ON EFI
INVESTIGATORS.
>> THANKS FOR THE GREAT WORK,
VERY IMPORTANT RECOMMENDATIONS.
I ASSUME THEN THE SALARY RATES
FOR TRAINING GRANTS WILL ALSO BE
ADJUSTED.
REMEMBER LIKE THE T32s AND SO
ON.
>> THE RECOMMENDATION IS FOR ALL
NRSAs INCLUDING --
>> INCLUDING Ts.
>> AND WE EXTEND OUT TO SAY WE
THINK THIS SHOULD BE APPLICABLE
REGARDLESS OF WHAT MECHANISM BUT
WE CAN SET THAT AT NIH FOR
AWARDS.
>> THINKING UP AND DOWN THE
PIPELINES, FIRST A COMMENT.
POSTDOCS ARE UNIONIZING ACROSS
CAMPUS, GRAD STUDENTS AS WELL.
THE $70,000 AMOUNT IF I READ
CORRECTLY IS EVEN HIGHER THAN
WHAT THEY NEGOTIATED WITH US,
AND THAT'S IRRESPECTIVE WHERE
YOU LEAVE, SO EVEN HIGHER FOR US
IN CALIFORNIA.
I WANT TO POINT OUT IF THE NRSA
IS 70,000, THE K AWARD COVERS
75,000 OF YOUR SALARY.
SO --
>> 75%.
>> UP TO 75,000 FOR SOME K99
AWARDS, OKAY, I WILL LOOK AT
THAT.
HOWARD BROUGHT UP THE USEFUL
POINT WHY TRAIN SO MANY GRAD
STUDENTS IF WE'RE GOING TO HAVE
TROUBLE FUNDING THEM AS
POSTDOCS.
>> THERE ARE A LOT OF THINGS CAN
YOU DO WITHOUT A POSTDOC.
BECOME THE DEPUTY DIRECTOR OF
NIH.
I DON'T MEAN TO BE FACETIOUS BUT
THERE ARE MANY CAREER PATHS
SOMEBODY WITH GRADUATE LEVEL
TRAINING COULD EMBARK ON THAT
DON'T NECESSARILY NEED A
POSTDOC.
BUT THAT'S ONE OF THE FACTORS TO
CONSIDER.
>> IT DOES MAKE IT COMPETITIVE
FOR THIS TRADITIONAL ACADEMIC
PATH.
AND THAT'S ALSO VERY SERIOUS
PART OF THESE CONSIDERATIONS.
>> YEAH, LIKE MAXIMUM SALARY
$75,000, A COUPLE OTHERS HAVE
100,000 BUT MAXIMUM FOR K IS THE
MINIMUM SALARY WOULD BE FOR AN
NRSA, WHICH IS FASCINATING TO
ME.
>> YEAH.
>> SO I APPRECIATE IT COULD MAKE
THINGS MORE COMPETITIVE, IT'S
IMPORTANT TO ANCHOR INTO THE
DATA CURRENTLY GOING ON WHICH IS
ME AS A P.I. WHO IS DOING QUITE
WELL HAVING A HARD TIME FINDING
POSTDOCS.
MY COLLEAGUES ARE HAVING HARD
TIMES FINDING POSTDOCS, THEIR
NUMBERS ARE GOING DOWN.
IF THIS IS STANDARD FORCES,
COMPETITIVE, SO WE'RE DOING THIS
TO RESPOND TO THREAT TO THE
SYSTEM THAT HAS EMERGED, AND
WE'RE WORRIED IF WE DON'T DO
SOMETHING AND YOU FOLLOW THIS
DOWN THE LINE, WE AREN'T GOING
TO BE ABLE TO FIND POSTDOCS
BECAUSE PEOPLE WON'T FIND THE
POSITION ATTRACTIVE.
THAT'S THE FRAMING THAT'S
IMPORTANT AS WE SHALL GOING
FORWARD.
>> I WANT TO VALIDATE THAT.
WE'RE REALLY ABOUT THE END
RESULT, TRYING TO ACHIEVE A
ROBUST AND WELL SUPPORTED
TALENTED WORKFORCE, AS WELL AS
GETTING OUR WORK DONE.
THE WORKFORCE IS CRITICAL NEED
FOR THE FUTURE.
>> THERE'S BEEN A LOT OF
DISCUSSION AROUND THE 70,000
NUMBER
WHAT SOME DATA SHOW IN THIS OF
INDUSTRY AVERAGE SALARY IS
BETWEEN SEVENTY AND EIGHTY
THOUSAND DOLLARS.
MANY RAISING RECENTLY HAVE BEEN
DOING SO TO AROUND $70,000, SO
THAT WAS SOME OF THE FACTORS
DRIVING IT.
WE ALSO BECAUSE WE DID HAVE THE
FORTUNE AND GET THAT PUT ON AN
ECONOMIST, WORKFORCE ECONOMIST,
SHE WAS MINDFUL OF KEEPING THE
NUMBER NOT TOO HIGH BECAUSE YOU
WOULD IMPINGE ON STARTING
SALARIES OF THOSE INTO ASSISTANT
PROFESSOR POSITIONS.
YOU WANT TO MAKE SURE THERE'S AN
ACTUAL SALARY INCREASE WHEN THEY
DO THAT.
>> THAT'S A TOOL OF POINT.
FOR SOME TYPES OF AWARDS MAY BE
VERY CLOSE IF NOT THERE.
>> I'M NOT SAYING THIS IS A BAD
THING.
WE WERE SPEAKING TO OURSELVES.
IF IT'S A LIMITED POOL AND PAID
MORE AND THAT CREATES MORE OF --
MORE OF AN ASPIRATION COMPARED
TO BEFORE THEN GETTING THE
POSTDOC MIGHT BE THE NEW GETTING
A FACULTY POSITION.
IT'S NOT GOING TO BE THAT EASY
OR AVAILABLE AND WHEN YOU GET IT
THEN YOU GET THE FUNDING.
AGAIN, WHICH MIGHT NOT BE A BAD
THING.
>> BRIAN.
>> I MEAN, SEEMS LIKE THE SALARY
IS THE NUMBER ONE
RECOMMENDATION, TOPIC OF
DISCUSSION, WONDERING IF IT'S
POSSIBLE TO MAKE A FRIENDLY
SUGGESTION FOR ADDENDUM OR
ADDITION TO REPORT WITH MORE
DETAIL OF THE ANALYSIS HOW YOU
ARRIVED AT THAT NUMBER?
BEFORE A LOT OF DISCUSSION AND
BENCHMARKING TO OTHER
INDUSTRIES, NUMBERS AREN'T
PROVIDED, WONDER PEOPLE WANT TO
KNOW MORE ABOUT THE ECONOMIC
DISCUSSIONS, ET CETERA, CITATION
TO THE SCIENCE ARTICLE WHICH
TALKS ABOUT MIT AND UC SYSTEM
AND PRINCETON.
THREE ELITE INSTITUTIONS,
DISCUSSIONS WE'VE BEEN HAVING
BEFORE, I'M SURE IT'S CLEAR YOU
LOOKED BEYOND THAT, RIGHT?
MAYBE AN ADDENDUM TO THE REPORT,
MORE DETAIL HOW YOU ARRIVED AT
THAT NUMBER WOULD BE HELPFUL.
>> ABSOLUTELY.
GREAT SUGGESTION.
>> OTHER COMMENTS OR QUESTIONS?
>> SO, I'M ASSUMING OUR TWO
CHAIRS WOULD LIKE TO PUT THIS
WORKING GROUP REPORT FORWARD TO
THIS COMMITTEE FOR A VOTE.
DO I HEAR A SECOND FOR THAT?
OKAY.
ANY FURTHER DISCUSSION?
ALL RIGHT.
IF NOT THEN LET'S HAVE A VOTE BY
SHOW OF HANDS, ALL IN FAVOR OF
APPROVING THIS WORKING GROUP
REPORT?
EXCELLENT.
ANY OPPOSED?
AND NO ABSTENTIONS.
ALL RIGHT.
THANK YOU VERY, VERY MUCH.
APPRECIATE ALL THE HARD WORK,
SERIOUSNESS OF THIS, AND
IMPLICATIONS WITH THIS BEING
ACCEPTED.
THE RESPONSIBILITY I WILL SAY
THAT IT PLACES ON US AT NIH WITH
THIS ACCEPTING THIS DOWNSTREAM
THAT WE THINK LONG AND HARD
ABOUT MITIGATION STRATEGIES FOR
UNANTICIPATED CONSEQUENCES
BECAUSE I -- THIS IS A BIG STEP.
I COMPLETELY AGREE, A CRITICAL
ONE.
BUT WE JUST WANT TO DO NO HARM.
OKAY.
THAT REALLY ENDS OUR AGENDA FOR
THIS ACD.
I WANT TO GIVE A SINCERE THANKS
TO THE TEAM HERE AT NIH WHO
WORKED SO HARD TO ORGANIZE
EVERYTHING SO WELL AND BE ABLE
TO HELP US PULL THIS OFF.
JOHN, THANK YOU, AND EVERYONE.
YOU PUT SO MUCH HARD WORK INTO
IT.
WITH THAT, I'M GOING TO GAVEL US
OUT AND SAY WE'RE ADJOURNED.
I LOOK FORWARD TO SEEING YOU
NEXT TIME.
THANK YOU.