WELCOME TO THE 126 MEETING OF
THE NIH ADVISORY COUNCIL TO THE
DIRECTOR.
I WANT TO THANK ALL OF YOU FOR
TAKING TIME OUT OF YOUR VERY
BUSY SCHEDULES TO BE WITH US,
BOTH TODAY AND TOMORROW.
THE PUBLIC MEETING TODAY WILL
RUN FROM 10 A.M. EAST COAST TIME
TO ABOUT 5:10 P.M.
AND THAT WILL BE FOLLOWED BY A
SHORT CLOSED SESSION, FROM ABOUT
5:10 P.M. TO 6 P.M., AGAIN EAST
COAST TIME.
AND THEN TOMORROW WE WILL HAVE A
PUBLIC SESSION FROM 10:30 A.M.
UNTIL 4:30 P.M., EAST COAST
TIME.
THE MEETING WILL BE RECORDED
BOTH DAYS, AND WILL BE MADE
AVAILABLE AFTER THE MEETING.
NOW, APPRECIATING HOW VERY FULL
OUR AGENDA IS FOR THE NEXT
COUPLE OF DAYS WE'RE GOING TO DO
OUR BEST TO STAY ON TIME, AND
ACTING PRINCIPAL DEPUTY DR. TARA
SCHWETZ WILL HELP US DO THAT.
TARA, LET ME TURN IT TO YOU TO
GO OVER LOGISTICAL ITEMS PLEASE
>> THANKS, LARRY.
SO, GOOD MORNING, EVERYONE.
JUST FOR THE LOGISTICAL DETAILS,
I'LL RUN THROUGH IT HERE IN A
SECOND.
SO, EXCEPT FOR CLOSED SESSION,
THE MEETING IS OPEN TO THE
PUBLIC, AS LARRY INDICATED.
THAT INCLUDES MEMBERS OF THE
PRESS AND IT'S ALSO BEING
WEBCAST.
SO JUST FOR YOUR REFERENCE.
THE MEETING PRESENTATIONS AND
ANY OF THE SUPPLEMENTAL
MATERIALS ARE GOING TO BE POSTED
ON THE ACD WEBSITE, SHORTLY
AFTER THE MEETING.
WE'LL ASSURE ALL OF THAT IS
PUBLICLY AVAILABLE.
THE MEETING ALSO WAS ANNOUNCED
IN THE FEDERAL REGISTER ON MAY
19, 2023.
AND OF NOTE, WE DID RECEIVE
PUBLIC COMMENT AND ACD MEMBERS
CAN WE REVIEW ON SHARE FILE SI.
WE'RE USING THE VIRTUAL FORMAT
ON ZOOM AS ACCUSTOMED TO OVER
THE LAST SEVERAL YEARS TODAY AND
TOMORROW.
PLEASE RAISE YOUR HAND VIRTUALLY
RATHER THAN USE THE CHAT TO POSE
A QUESTION OR MAKE A COMMENT.
IT MAKES THINGS EASIER AND
SMOOTHER.
AND WHEN AN ACD MEMBER DOES WISH
TO MAKE A COMMENT, WE ASK THAT
YOU PLEASE MAKE SURE TO TURN ON
YOUR VIDEO AND YOUR MIC, IF YOU
CAN, SO THAT WE'RE RECORDING
MORE THAN JUST A BLACK BOX WITH
YOUR NAME ON IT.
BUT WITH THAT I'M GOING TO TURN
IT BACK OVER TO LARRY.
>> THANKS VERY MUCH, TARA.
WHAT I'D LIKE TO DO NOW, IF WE
COULD PULL UP THE AGENDA FOR THE
MEETING.
IS THAT POSSIBLE?
WELL, I'LL JUST SPEAK TO IT.
WE'LL BEGIN THE MEETING WITH
DIRECTOR'S REPORT.
AS YOU KNOW, THAT WILL INCLUDE
BOTH A BUDGET UPDATE AND
LEGISLATIVE UPDATE BY NEIL
SHAPIRO AND LAUREN HIGGINS,
RESPECTIVELY.
OH, THANKS VERY MUCH.
APPRECIATE IT.
WE'LL GIVE YOU A SHORT BREAK
AFTER THE DIRECTORS REPORT.
AND 11:15 A.M., EAST COAST TIME,
LYRIC JORGENSEN WILL REVIEW THE
PUBLIC ACCESS PLAN, FOLLOWED BY
A PRESENTATION ABOUT THE CANCER
MOONSHOT BY MONICA BERTAGNOLLI,
THE DIRECTOR OF THE NCI.
AGAIN, WE'LL GIVE YOU A SHORT
BREAK FOR LUNCH, FOR THOSE OF US
HERE ON EAST COAST TIME.
AND THEN AT 1:45 DR. SHELLI
AVENEVOLI, DEPUTY DIRECTOR AT
NIMH, WILL GIVE A PRESENTATION
ON ADDRESSING MENTAL HEALTH
CRISIS THROUGH RESEARCH.
SHORT BREAK.
AND THEN DR. GARY GIBBONS,
DIRECTOR OF NHLBI, WILL PRESENT
ON HOW NIH IS ADDRESSING THE
PUBLIC HEALTH THREAT OF
POST-ACUTE SEQUELAE OF
SARS-COV-2 INFECTION, PASC,
THROUGH THE NIH RECOVER
INITIATIVE.
AT 4 P.M., DR. JULIE GERBERDING,
CEO OF THE FOUNDATION FOR NIH,
WILL PRESENT SOME OF HER MOST
RECENT EFFORTS.
AND THEN WE'LL CLOSE WITH A
SHORT -- VERY BRIEF COMMENTS,
ADJOURN, AND PROCEED TO CLOSED
SESSION WHERE ONLY MEMBERS OF
THE COUNCIL WILL PARTICIPATE.
ON FRIDAY, DR. DEB TUCCI,
DIRECTOR OF NIDCD, WILL PRESENT
ON CLINICAL TRIAL STEWARDSHIP,
FOLLOWED BY DR. MARIE BERNARD,
UPDATE ON ACCESSIBILITY EFFORTS
AT NIH.
A QUICK BREAK FOR LUNCH, HERE ON
THE EAST COAST.
AT 12:30 THE HeLa GENOME
ACCESS WORKING GROUP WILL
PRESENT DATA ACCESS REQUESTS,
GARTH GRAHAM AND LYRIC JORGENSON
WILL MAKE THOSE REQUESTS KNOWN.
12:45 DR. RICK WOYCHIK, DIRECTOR
OF NIEHS, WILL SUMMARIZE SOME OF
THE NIH-WIDE COLLABORATIVE
INITIATIVES ON CLIMATE CHANGE
AND HEALTH.
FOLLOWING A SHORT BREAK, WE'LL
HAVE AN UPDATE FROM THE ACD
WORKING GROUP ON CATALYZING THE
DEVELOPMENT AND USE OF NOVEL
ALTERNATIVE METHODS TO ADVANCE
BIOMEDICAL RESEARCH, DOCTORS
HOWARD CHANG AND LYRIC JORGENSON
WILL DO THAT PRESENTATION,
FOLLOWED BY AT 3 P.M. AN UPDATE
FROM ACD WORKING GROUP ON
RE-ENVISIONING NIH-SUPPORTED
POSTDOCTORAL TRAINING PRESENTED
BY DOCTORS SHELLEY BERGER AND
TARA SCHWETZ.
VERY FULL SCHEDULE.
WE'LL KEEP CLOSING COMMENTS TO A
MINIMUM.
BUT I'M SURE YOU CAN APPRECIATE
THAT EACH TOPIC IS SUBSTANTIVE
AND TIMELY, AND OF COURSE THE
PRESENTATIONS ARE THERE TO FRAME
THE DISCUSSION THAT WILL BE HELD
WITH THE COUNCIL.
AND THAT IS REALLY THE CORE OF
WHAT THE ADVISORY COMMITTEE IS
ABOUT, TO HAVE, YOU KNOW, FULL
DISCUSSION IN A PUBLIC FORUM,
AND SO PLEASE, ALTHOUGH I KNOW
THIS GROUP IS NOT BASHFUL,
PLEASE DO ENGAGE WITH THE TOPICS
AS THEY ARE PRESENTED.
NOW IF WE COULD PULL UP THE
SLIDE DECK PLEASE AND GO TO
SLIDE 3.
I WANTED TO WELCOME SOME NEW
FACES WHO ARE PARTICIPATING
TODAY, AD HOC MEMBERS OF THE ACD
WHILE THEIR MEMBERSHIPS ARE
BEING CONSIDERED TO THE BOARD.
IF I BUTCHER THE PRONUNCIATION
OF YOUR NAME, PLEASE, PLEASE
CORRECT ME, AND AAPOLOGIZE IN
ADVANCE.
DR. ONAMACHADO FROM YALE,
PROFESSOR THE MEDICINE AND
BIOMEDICAL INFORMATICS AND DATA
SCIENCE, DEPUTY DEAN FOR
BIOMEDICAL INFORMATICS AND CHAIR
OF THE BIOMEDICAL INFORMATICS
AND DATA SCIENCE, WELCOME.
DR. CORY MOORE, FROM LANGSTON
UNIVERSITY, CHAIR AND PROFESSOR
OF THE DEPARTMENT OF
REHABILITATION AND DISABILITY
STUDIES, PRINCIPAL INVESTIGATOR
AND RESEARCH DIRECTOR FOR
REHABILITATION RESEARCH AND
TRAINING CENTERS ON RESEARCH AND
CAPACITY BUILDING FOR MINORITY
ENTITIES ON ADVANCING EMPLOYMENT
EQUITY FOR MULTI-PLI
MARGINALIZED PERSONS WITH
DISABILITIES.
DR. TASHA SOLOMON FROM
UNIVERSITY OF ARIZONA, ASSOCIATE
PROFESSOR, DEPARTMENT OF FAMILY
AND COMMUNITY MEDICINE, FORMER
DIRECTOR OF THE NATIVE AMERICAN
RESEARCH AND TRAINING CENTER.
DR. BRIAN MUSTANSKI,
NORTHWESTERN UNIVERSITY,
FEINBERG SCHOOL OF MEDICINE,
PROFESSOR OF MEDICAL SOCIAL
SCIENCES, PSYCHIATRY, BEHAVIORAL
SCIENCES, PSYCHOLOGY, AND
DIRECTOR OF THE INSTITUTE FOR
SEXUAL AND GENDER MINORITY
HEALTH AND WELL BEING.
FINALLY DR. GISELLE CORBY, UNC
SCHOOL OF MEDICINE, THE KEENAN
DIRECTOR OF PROFESSOR FOR SOCIAL
MEDICINE, VICE PROVOST FOR
FACULTY AFFAIRS, PROFESSOR OF
INTERNAL MEDICINE.
WE'RE EXCITED TO HAVE YOU AND
APPRECIATE YOUR WILLINGNESS TO
SHARE YOUR EXPERTISE, SO REALLY,
WELCOME.
AND AS WE WELCOME THESE NEW
VOICES, WE ALSO WANT TO
ACKNOWLEDGE SEVERAL ACD MEMBERS
WHO GRACIOUSLY AGREED TO EXTEND
THEIR SERVICE TO THIS MEETING,
BUT NOW WILL NEED TO ROTATE OFF.
THE GOOD NEWS IS, IT
DEMONSTRATES THE ACD IS NOT A
LIFE SENTENCE, BUT NEVERTHELESS
WE'RE VERY SORRY THAT THESE
FOLKS ARE ROTATING OFF.
FIRST DR. SHELLEY BERGER, FROM
UNIVERSITY OF PENNSYLVANIA, AND
YOU WILL HEAR FROM DR. BERGER
LATER, AS SHE HAS TAKEN UP THE
MANTLE, ON THE REENVISIONS
NIH-SUPPORTED DOCTORAL TRAINING
EFFORT.
DR. ROBERT BRINTON, UNIVERSITY
OF ARIZONA, AGAIN THANK YOU SO
MUCH FOR YOUR TREMENDOUS
CONTRIBUTIONS AND IN PARTICULAR
YOUR SERVICE AS CO-CHAIR OF THE
ACD WORKING GROUP ON DIVERSITY.
AND THEN FINALLY DR. BARBARA
WAHL, CAL TECH, WHO I WORKED
WITH CLOSELY AS CO-CHAIRS OF ACD
WORKING GROUP ON ENHANCING
RIGOR, TRANSPARENCY, AND
TRANSLATABILITY IN ANIMAL
RESEARCH.
I CAN'T BEGIN TO SAY HOW MUCH WE
HAVE APPRECIATED THE WISDOM AND
INSIGHT THAT THESE MEMBERS HAVE
GIVEN TO US, OVER THE PAST
SEVERAL YEARS.
AND WE REALLY DO SAY THANK YOU.
LOOKING FORWARD TO YOUR
CONTRIBUTIONS TODAY.
WITH REGARD TO OTHER LEADERSHIP
CHANGE TO MAKE YOU AWARE OF,
NEXT SLIDE PLEASE.
I'M SURE YOU'RE AWARE PRESIDENT
BIDEN HAS NOMINATED DR. MONICA
BERTAGNOLLI, THE CURRENT
DIRECTOR OF THE NATIONAL CANCER
INSTITUTE, AS THE NEXT NIH
DIRECTOR.
I'LL LEAVE IT TO LAUREN HIGGINS
TO EXPLAIN THE PROCESS THAT
NEEDS TO BE FOLLOWED THROUGH
CONFIRMATION OF DR. BERTAGNOLLI.
NEXT SLIDE PLEASE.
WE HAVE A NUMBER OF SEARCHES
ONGOING FOR LEADERSHIP.
AND SO THERE ARE SOME NEW FACES
WITH THE COUNCIL TODAY.
I JUST WANT TO ALERT YOU TO WHO
THESE FOLKS ARE.
I'VE ALREADY MENTIONED LAUREN
HIGGINS, WHO IS THE ACTING
ASSOCIATE DIRECTOR FOR
LEGISLATIVE POLICY AND ANALYSIS.
SHE GRACIOUSLY STEPPED IN WHEN
ADRIENNE HALLET STEPPED DOWN
FROM THIS ROLE AND WE'RE VERY,
VERY APPRECIATIVE OF LAUREN
DOING THIS FOR US WHILE A
NATIONWIDE SEARCH IS ONGOING FOR
THE PERMANENT DIRECTOR.
NEXT SLIDE PLEASE.
ALSO I WANT TO THANK DR. DAVID
MURRAY FOR SERVING AS ACTING
DIRECTOR FOR OFFICE OF DIETARY
SUPPLEMENTS, PLEASED TO ANNOUNCE
THAT DR. STEPHAN PASIAKOS WILL
BEGIN SERVING AS DIRECTOR OF
OFFICE OF DIETARY SUPPLEMENTS IN
MID-JULY.
HE'S CURRENTLY A PHYSIOLOGIST AT
THE ARMY INSTITUTE OF
ENVIRONMENTAL MEDICINE.
AND SO WE LOOK FORWARD TO
GREETING HIM SHORTLY.
IF I COULD HAVE THE NEXT SLIDE
PLEASE.
WE'RE VERY GRATEFUL TO DR. BILL
KAPOGIANNIS FOR STEPPING UP AS
ACTING ASSOCIATE DIRECTOR OF
OFFICE OF AIDS RESEARCH, AND THE
ACTING DIRECTOR WE'RE CURRENTLY
ENGAGED IN A NATIONWIDE SEARCH
FOR A NEW DIRECTOR TO REPLACE
DR. MAUREEN GUTENOW WHO LED FOR
SEVEN YEARS.
NEXT SLIDE PLEASE.
THANKS GO TO DR. WENDY SMITH WHO
WILL BE STEPPING IN TO SERVE AS
ACTING ASSOCIATE DIRECTOR FOR
BEHAVIORAL AND SOCIAL SCIENCES
RESEARCH, FOLLOWING THE RECENT
RETIREMENT OF DR. CHRISTINE
HUNTER, WHO HAD BEEN SERVING IN
THE ACTING DIRECTOR CAPACITY.
THERE IS AN ACTIVE SEARCH
ONGOING, AND WE HOPE TO BE ABLE
TO SHARE WITH YOU THE RESULTS OF
THAT IN THE NOT TOO DISTANT
FUTURE.
AND THEN FINALLY IF I COULD HAVE
THE NEXT SLIDE PLEASE, WE'RE
DELIGHTED TO WELCOME DR. KARINA
WALTERS AS NEW DIRECTOR OF THE
NIH TRIBAL HEALTH RESEARCH
OFFICE, A MEMBER OF THE CHOCTAW
NATION OF OKLAHOMA BRINGING A
WEALTH OF EXPERIENCE AND DEEP
COMMITMENT TO ENGAGING TRIBAL
NATIONS AND THEIR LEADERSHIP IN
HEALTH RESEARCH EFFORTS, AND WE
HAVE ALREADY BEGUN WORKING VERY
CLOSELY WITH DR. WALTERS ON A
NUMBER OF ISSUES RELATED TO
TRIBAL HEALTH.
NEXT PLEASE.
SO I WANT TO BRAG A LITTLE BIT
ABOUT SOME NIH FOLKS, SOME
AWARDS.
NEXT PLEASE.
WE HAVE THE SO-CALLED SAMMY
AWARDS, SERVICE TO AMERICA
AWARDS.
IN 2023 I'M DELIGHTED WE HAVE
TWO SETS OF FINALISTS.
NHGRI TELOMERES TO TELOMERES
TEAM LED BY DR. PHILIPY, KOREN,
AND RHIE, IN THE RUNNING FOR THE
2023 SCIENCE TECHNOLOGY IENCE TD
ENVIRONMENT MEDAL.
INSTRUMENTAL IN CRACKING THE
LAST 8% OF THE GENETIC CODE,
MYRIAD OF INSIGHT TO COMPLEXITY
OF DNA AND ITS RELATIONSHIP TO
HEALTH, A VERY LARGE
COLLABORATIVE EFFORT, AND THESE
ARE THE FOLKS WHO LED MUCH OF
THE COORDINATION.
THANK YOU TO THEM.
WISH THEM LUCK.
NEXT SLIDE PLEASE.
DR. ERIC ROCKY FEUER IS A
FINALIST FOR VOLCKER CAREER
ACHIEVEMENT MEDAL, USING
STATISTICAL ANALYSIS OVER THE
COURSE OF HIS CAREER IN
UNDERSTANDING IMPACT OF CANCER
IN THE U.S.
HE'S USED DATA TO DEMONSTRATE
HOW NEW PREVENTION SCREENING AND
TREATMENT OPTIONS COULD HELP
REDUCE CANCER RATES.
NOW, AS A PLUG, THE PUBLIC CAN
VOTE FOR THEIR CHOICE IN THE
2023 PUBLIC CHOICE AWARDS VIA
THE PARTNERSHIP FOR PUBLIC
SERVICE'S WEBSITE UNTIL JUNE
30th.
SO, I DO HOPE THAT SOME OF YOU
TAKE ADVANTAGE OF THAT TO HELP
HONOR THESE INDIVIDUALS.
I HOPE YOU JOIN ME IN, YOU KNOW,
APPLAUDING, IF YOU WILL,
VIRTUALLY THE OUTSTANDING
ACCOMPLISHMENTS OF THESE FOLKS.
IF I COULD HAVE THE NEXT SLIDE
PLEASE.
SO, WE RECENTLY HAD A
GROUNDBREAKING CEREMONY.
NEXT SLIDE PLEASE.
A NEW SURGERY, RADIOLOGY, AND
LABORATORY MEDICINE WING OF THE
CLINICAL CENTER HAS STARTED
CONSTRUCTION, BEGINNING WITH
THIS CEREMONIAL TURNING OF THE
SOIL, IF YOU WILL.
AND IN THE CENTER OF OF THE
PICTURE HERE IS ANDREA POM,
DEPUTY SECRETARY, DEPARTMENT OF
HEALTH AND HUMAN SERVICES, WE
WERE DELIGHTED TO HOST HER ON
MAY 16 FOR THIS CEREMONY.
MANY, MANY, MANY PEOPLE MADE
THIS HAPPEN.
THE CONGRESS, OMB, THE
DEPARTMENT, THE MONTGOMERY
COUNTY DELEGATION, AND MANY,
MANY, MANY LEADERS ACROSS NIH.
THIS ADDITION IS SCHEDULED FOR
COMPLETION IN 2029.
AND WILL ENABLE OF COURSE THE
CONTINUED DISCOVERY USING
STATE-OF-THE-ART DIAGNOSTICS,
THERAPIES, AND CURES FOR A WIDE
RANGE OF DISEASES AND CONDITIONS
STUDIED IN THE CLINICAL CENTER.
NEEDLESS TO SAY, WE'RE
DELIGHTED.
THIS IS GOING TO BE A 547,000
SQUARE FOOT ADDITION, AND IT'S
OBVIOUSLY A VERY SUBSTANTIVE
PROJECT.
AND WE'RE JUST SO THRILLED IT
HAS BEGUN.
IF I COULD HAVE THE NEXT SLIDE
PLEASE.
I WANT TO MENTION TO YOU ABOUT
AN INITIATIVE THAT WE HAVE
UNDERTAKEN, AN NIH VIRTUAL TOUR.
NEXT SLIDE PLEASE.
SO, WE'LL BE LAUNCHING THIS
FORMALLY NEXT WEEK.
IT IS A DIGITAL EXPERIENCE THAT
SEEKS TO HELP THE PUBLIC LEARN
MORE ABOUT THE NIH AND HOW WE
WORK TO HELP AMERICANS LIVE
LONGER, HEALTHIER LIVES, ALL
ASPECT OF THE TOUR ARE 508
COMPLIANT TO ENSURE ALL WILL
HAVE ACCESS TO THIS INFORMATION.
VISITORS WILL BE ABLE TO EXPLORE
THE VIRTUAL TOUR THROUGH GUIDED
TOUR STOPS THAT PROVIDE AN
OVERVIEW OF THE NIH'S MISSION,
INTRODUCE THEM TO PEOPLE ACROSS
THE CAMPUS, THE RESEARCH THAT'S
BEING CONDUCTED, THE FACILITIES
THAT ARE HERE, PARTICULARLY OF
INTEREST TO PATIENTS WHO VISIT
THE CLINICAL CENTER.
AS PART OF THIS, YOU'LL FIND
INTERVIEWS WITH SENIOR LEADERS,
WITH ADMINISTRATORS, WITH
SCIENTISTS, PHYSICIANS,
TRAINEES, OTHER CLINICIANS AND
PATIENTS.
IMPORTANTLY, FOR PEOPLE LIKE MY
SPATIALLY CHALLENGED THERE'S AN
INTERACTIVE MAP SO YOU CAN FIND
WHERE YOU'RE GOING ON CAMPUS.
ONE IT -- ONCE IT GOES LIVE
WE'LL PROVIDE YOU WITH A LINK
AND REALLY ENCOURAGE YOU TO
EXPLORE THIS.
TREMENDOUS CREDIT GOES TO RENATA
MILES, ACTING DIRECTOR OF
COMMUNICATION, PATIENT LIAISON
BRANCH, AND HER EXTENSIVE TEAM
THAT WORKED WITH CIT AND OTHER
EQUITIES ACROSS THE CAMPUS TO
MAKE THIS HAPPEN.
SO, PLEASE BE ON THE LOOKOUT FOR
THAT.
NEXT SLIDE PLEASE.
NOW A BRIEF UPDATE ON THE
PROGRESS OF THE NIH-WIDE
DIVERSITY, EQUITY, INCLUSION,
AND ACCESSIBILITY STRATEGIC
PLAN, IF I COULD HAVE THAT NEXT
SLIDE PLEASE.
THIS PLAN WHICH COVERS PROJECTED
EFFORTS FROM 2023 THROUGH 2027
REALLY THINK DOES A GOOD JOB
ARTICULATING THE AGENCY'S VISION
FOR EMBRACING, FOR
STRENGTHENING, AND FOR
INTEGRATING ALL DIVERSITY,
EQUITY, INCLUSION, AND
ACCESSIBILITY ISSUES ACROSS THE
NUMEROUS ACTIVITIES THAT ARE
OCCURRING ACROSS THE CAMPUS.
IT PRESENTS OUR DEIA PRIORITIES
IN THREE AREAS IN THE FORM OF
OBJECTIVES, WHICH ARE LISTED
THERE.
AND ACROSS ALL THESE PRIORITIES,
NIH WILL BE EMPHASIZING
CROSS-CUTTING THEMES, APPROACHES
THAT ARE COMMON TO ALL
OBJECTIVES OF THE PLAN, AND
THAT'S LOCATED IN THE LOWER
RIGHT-HAND QUADRANT OF THIS
FIGURE.
THE PLAN HIGHLIGHTS ONGOING
EFFORTS.
IT GIVES YOU SOME INSIGHTS INTO
FUTURE EFFORTS THAT WILL BE USED
TO FOSTER DEIA WITHIN THE
BIOMEDICAL AND BEHAVIORAL
RESEARCH ENTERPRISE, AND IT
PROVIDES A GUIDE, IF YOU WILL,
FOR ACTIONS ACROSS THE AGENCY
THAT WILL ENSURE THAT WE PROCEED
IN A TRANSPARENT AND ACCOUNTABLE
MANNER, TO ENSURE THAT THE PLAN
IS -- APPROPRIATELY CONSIDERS A
BROAD RANGE OF PERSPECTIVES, WE
SOUGHT INPUT FROM MANY, MANY,
MANY QUARTERS.
THE COMMUNITY AT LARGE,
INCLUDING OUR OWN NIH STAFF.
WE REACHED OUT TO EXTRAMURAL
INSTITUTIONS, OUR SO-CALLED
FUNDED INSTITUTIONS.
AND THEN WE RECEIVED QUITE A
BIT OF INPUT FROM THE GENERAL
PUBLIC THROUGH A VARIETY OF
FORA, INCLUDING REQUEST FOR
INFORMATION.
I WANT TO THANK EVERYBODY WHO
PROVIDED INPUT INTO THE NEW
STRATEGIC PLAN, AND WE'RE NOW
QUITE A WAYS AWAY INTO THE
PLANNING OF A COMPREHENSIVE AND
INTENTIONAL APPROACH TO THE
IMPLEMENTATION OF ALL OF THESE
ELEMENTS.
SO PLEASE STAY TUNED FOR THAT
COMPANION EFFORT TO BE SHARED
WITH YOU ONCE IT IS READY.
IF I COULD HAVE THE NEXT SLIDE
PLEASE.
SO, WE'RE NOW EMBARKING ON A
CADENCE WHERE UNITE -- WE'LL
GIVE YOU AN UPDATE OF UNITE
ACTIVITIES IN MY DIRECTOR'S
REPORT, WITH ANTICIPATION THAT
IT WILL BE PRESENTED AS A FORMAL
PRESENTATION IN THE NEXT
ADVISORY COMMITTEE TO THE
DIRECTOR.
IF I COULD HAVE SLIDE NUMBER 20
PLEASE.
SO JUST A FEW VERY EXCITING
DEVELOPMENTS.
THE COMMON FUND'S COMMUNITY
PARTNERSHIPS TO ADVANCE SCIENCE
FOR SOCIETY, THE SO-CALLED
COMPASS PROGRAM, HAS FULLY
RELEASED ALL FUNDING
SOLICITATIONS AND WE SHOULD HAVE
DECISIONS ABOUT AWARDS BY THE
END OF THIS FISCAL YEAR.
YOU MAY RECALL THAT COMPASS CAME
ABOUT AS A RESULT OF UNIT
ADVOCATING RESEARCH, INCLUDING
TWO CO-LEADS, DOCTORS JANINE
CLAYTON AND SHANNON ZENK.
THE COMMUNITY-LED HEALTH EQUITY
STRUCTURAL INTERVENTIONS AND
HEALTH EQUITY RESEARCH HUBS AND
COMPASS COORDINATE NATION CENTER
WILL COLLECTIVELY DEVELOP,
SHARE, EVALUATE COMMUNITY-LED
HEALTH EQUITY STRUCTURAL
INTERVENTIONS THAT AIM TO
LEVERAGE PARTNERSHIPS ACROSS
MULTIPLE SECTORS TO REDUCE
HEALTH DISPARITIES.
SO WE'RE SEEKING TANGIBLE
INTERVENTIONS THAT WILL MAKE
SUBSTANTIVE DIFFERENCES.
AND THE IDEA OF COURSE IS TO
DEVELOP A NEW HEALTH EQUITY
RESEARCH MODEL FOR COMMUNITY-LED
MULTI-SECTIONAL STRUCTURAL
INTERVENTIONAL RESEARCH ACROSS
NIH, AND WE HOPE THAT THIS IS
PICKED UP BY OTHER FEDERAL
AGENCIES TO GUIDE THEIR EFFORTS
AS WELL.
NEXT SLIDE PLEASE.
TO CONTINUE WITH OTHER
ACTIVITIES, SEVERAL FUNDING
OPPORTUNITIES HAVE BEEN
RELEASED.
THE SECOND ROUND OF
SOLICITATIONS FOR THE SEPA
AWARDS, THESE ARE -- HAS BEEN
ANNOUNCED.
THIS IS A PROGRAM WHICH PROVIDES
STEM EDUCATION THROUGH K-12.
NOW, ORIGINALLY THIS WAS SOLELY
THE PURVIEW OF NIGMS BUT WE'VE
EXPANDED THIS NOW, I'M PLEASED
TO SAY, TO A NUMBER OF
ADDITIONAL INSTITUTES, CENTERING
AND OFFICES AT NIH, 17 IN ALL.
WE THINK THAT IT'S VERY
IMPORTANT TO, YOU KNOW, TRY AND
ENGAGE WITH YOUTH EARLY,
BECAUSE, AGAIN, AS EDUCATORS
WILL TELL US, SCIENCE IDENTITY
IS FORMED, YOU KNOW, EARLY IN
MIDDLE SCHOOL EXPERIENCE.
SO, WE THINK THIS IS A TIMELY
AND AN IMPORTANT EFFORT.
ALSO SHOWN ON THIS SLIDE ARE
THREE OTHER RECENTLY RELEASED
NOTICES OF INTEREST, NOFOs.
AND WE CERTAINLY ENCOURAGE
INTERESTED PARTIES TO APPLY TO
THESE THREE PROGRAMS.
THE REWARD EFFORT,
INSTRUMENTATION GRANTS FOR
RESOURCE-LIMITED INSTITUTIONS,
AND THE SO-CALLED STRONG
PROGRAM.
THE LINKS ARE PROVIDED.
AND YOU'LL BE ABLE TO
INTERROGATE THEM TO GET
ADDITIONAL INFORMATION.
NEXT SLIDE PLEASE.
WE'RE ALSO EXCITED TO ANNOUNCE
THE NIH INSTITUTIONAL EXCELLENCE
IN DEIA PRIZE COMPETITION.
THIS HAS BEEN LAUNCHED.
THE GOAL HERE IS TO RECOGNIZE
TRANSFORMATIVE CULTURE SYSTEMS
PROJECTS AND PROCESSES THAT HAVE
BEEN DEVELOPED BY ACADEMIC
INSTITUTIONS TO PROMOTE
INCLUSIVE EXCELLENCE, CREATE
ENVIRONMENTS THAT FOSTER AND
VALUE DEIA CULTURE.
SUBMISSIONS DUE ON THE 26th.
AGAIN, ADDITIONAL DETAILS CAN BE
FOUND AT THE NIH DEIA PRIZE.ORG
WEBSITE.
NEXT SLIDE PLEASE.
AND THIS IS GIVING YOU THAT
INFORMATION.
WE HOPE TO ANNOUNCE WINNERS
BEFORE THE END OF THE THE
CALENDAR YEAR, DECEMBER 2023
NEXT SLIDE PLEASE.
FINALLY AS PART OF UNITE WE HAVE
SOUGHT BROAD COMMUNITY INPUT,
BOTH THROUGH A REQUEST FOR
INFORMATION WHERE WE RECEIVED
OVER 1100 SUBMISSIONS FROM BOTH
INDIVIDUALS AS WELL AS
ORGANIZATIONS.
AND ANALYSIS OF THE RFI
RESPONSES YIELDED A NUMBER OF
KEY AREAS AND CROSS-CUTTING
THEMES.
THE FULL REPORT CAN BE FOUND ON
THE UNITE WEBSITE.
ADDITIONALLY A SUMMARY REPORT OF
THE UNITE EXTERNAL LISTENING
SESSIONS CAN ALSO BE FOUND ON
THIS SITE.
WE WERE ABLE TO GATHER
PERSPECTIVES FROM JUST UNDER
1300 INDIVIDUALS, WHO
REPRESENTED MULTIPLE RESEARCH
COMMUNITY SECTORS, OVER THE 14
LISTENING SESSIONS THAT OUR TEAM
HELD FROM DECEMBER 2020 THROUGH
FEBRUARY OF 2021.
I WANT TO THANK THE ENTIRE
COMMUNITY FOR REALLY ALL OF
THEIR TIME AND EFFORT IN SHARING
THEIR PERSPECTIVES AND FOR MY
COLLEAGUES WHO ARE PART OF UNITE
WHO HAVE DONE SUCH A GREAT JOB
COLLATING AND ANALYZING ALL OF
THIS INFORMATION.
ALL OF THIS IS GOING TO REALLY
PLAY AN IMPORTANT ROLE IN
SHAPING NIH EFFORTS GOING
FORWARD.
OKAY, NEXT SLIDE PLEASE.
TO CHANGE GEARS NOW I'D LIKE TO
JUST TOUCH UPON SOME ASPECTS OF
THE SIMPLIFYING REVIEW CRITERIA
EFFORT.
NEXT SLIDE PLEASE.
YOU MAY RECALL AT THE DECEMBER
ACD MEETING DR. NONI BYRNES,
LECTOR OF CENTER FOR SCIENTIFIC
REVIEW, PRESENTED THE PROPOSED
NEW FRAMEWORK FOR REVIEW
CRITERIA, WHICH IS PROVIDING A
QUICK UPDATE HERE, AND SO,
AGAIN, YOU WILL RECALL OVERALL
THREE FACTORS, IMPORTANCE OF
RESEARCH, RIGOR AND FEASIBILITY,
AND EXPERTISE AND RESOURCES.
AND WE RECEIVED AN RFI THAT
REALLY GOT A ROBUST RESPONSE,
780 INDIVIDUALS, 30 SOCIETIES,
23 ACADEMIC INSTITUTIONS,
MAJORITY WERE VERY SUPPORTIVE.
MINORITY OF THE RESPONDENTS FELT
FACTOR 3 SHOULD BE SCORED, EVEN
A SMALLER MINORITY OF
INDIVIDUALS RECOMMENDED BLINDED
REVIEWS.
WE'VE DISCUSSED BLINDED REVIEWS
AND DIFFICULTIES IN DOING THAT,
IN PRACTICAL TERMS, A NUMBER OF
TIMES OVER THE YEARS.
AND VIRTUALLY EVERYBODY CALLED
FOR STRONG TRAINING RESOURCES TO
ENSURE APPROPRIATE SOCIALIZATION
OF THESE CHANGES FOR REVIEWERS
AND CHAIRS OF THE PANELS AND OF
COURSE STAFF.
SO NEXT STEPS ARE ACROSS THE
AGENCY IMPLEMENTATION COMMITTEE
WHICH HAS A MULTI-DIMENSIONAL
EXPERTISE IN PEER REVIEW,
REVIEWER TRAINING, STAFF
TRAINING, ELECTRONIC SYSTEMS,
CONSIDERING A ROLLOUT STRATEGY.
SO IF WE COULD HAVE THE NEXT
SLIDE PLEASE.
SO, WE'RE NOW ALSO CONSIDERING
HOW TO BEST SIMPLIFY REVIEW FOR
THE NRSA FELLOWSHIPS TO ADDRESS
CONCERNS THAT THE CURRENT REVIEW
PROCESS HAS DISADVANTAGED SOME
VERY HIGHLY QUALIFIED AND
PROMISING APPLICANTS.
DATA ANALYSIS OF 6,000
APPLICATIONS HAS SUGGESTED THAT
THE MAJORITY OF FELLOWSHIP
APPLICATIONS ARE SUBMITTED BY A
VERY TINY NUMBER OF
INSTITUTIONS.
AND NOT SURPRISINGLY, THOSE
INSTITUTIONS DO FAR BETTER IN
REVIEW.
AND SO WE'RE LOOKING AT WAYS OF
REVISING BOTH THE REVIEW
CRITERIA FOR THE FELLOWSHIPS AND
APPLICATIONS SO THEY BETTER
ALIGN WITH THESE CRITERIA.
TO RECEIVE FEEDBACK ON THIS,
WE'VE RELEASED AN RFI, REQUEST
FOR INFORMATION, OPEN THROUGH
NEXT WEEK, JUNE 23.
PLEASE SHARE THE NEWS OF THIS
RFI WITH YOUR NETWORKS.
WE WOULD LIKE TO HEAR FROM AS
MANY PEOPLE AS POSSIBLE, AND THE
LINK TO THE RFI IS NOTED ON THE
SLIDE.
LET'S GO TO THE NEXT SLIDE
PLEASE.
SO, VERY QUICK UPDATE ON COVID.
NEXT PLEASE.
SO BASED ON A FRAMEWORK
DEVELOPED BY THE W.H.O., NIH
ESTABLISHED A COVID-19
INTRAACTION REVIEW WHICH TRIED
TO CAPTURE ONGOING EXPERIENCES,
LESSONS LEARNED, AND THE MANY
GOALS THAT EMERGE FROM OUR
EFFORTS DURING THE PANDEMIC.
AND OF COURSE THE WHOLE POINT OF
THIS IS TO BETTER PREPARE US FOR
THE FUTURE, FOR UNEXPECTED
EVENTS, FOR EMERGENCIES, WHICH
NO DOUBT WILL OCCUR IN ONE FORM
OR ANOTHER.
THE TEAM USED AN INQUIRY-BASED
PROCESS.
THEY CONDUCTED INTERVIEWS, BASED
ON KEY THEMES WITH LEADERS FROM
THE NIH, WITH PEER
ORGANIZATIONS, INCLUDING BOTH
FEDERAL AND UNIVERSITY PARTNERS.
AND THESE INTERVIEWS CAPTURED A
BROAD RANGE OF EXPERIENCES, AND
REALLY DID INFORM
RECOMMENDATIONS ESTABLISHED BY
NIH IN OUR FINAL LESSONS LEARNED
REPORT.
THE KEY THEMES THAT EYE MERGED
ARE OUTLINED HERE UNDER THE
CATEGORIES OF WORKFORCE,
OPERATIONS, INFRASTRUCTURE,
COMMUNICATIONS, AND INNOVATIVE
SCIENTIFIC COLLABORATIONS.
AND I WON'T READ THE SLIDE TO
YOU, BUT YOU CAN SEE UNDER EACH
OF THESE KEY AREAS THE TOP LINE
MESSAGES ARE CAPTURED.
AND I HAVE NO DOUBT THAT THIS
EFFORT AND OF COURSE THE DETAIL
CONTAINED WITHIN THE ACTUAL
REPORT WILL BE OF GREAT VALUE TO
DEAL WITH FUTURE ISSUES.
NEXT SLIDE PLEASE.
YOU'RE GOING TO RECEIVE A VERY
DETAILED REPORT ON RECOVER BY
DR. GIBBONS LATER ON IN THE
PROGRAM.
BUT IN CASE THERE'S SOME FOLKS
WHO HAVE JUST TUNED IN FOR THE
DIRECTOR'S REPORT ONLY, I DID
WANT TO JUST SAY THAT OUR
RECOVER INITIATIVE IS WORKING
TOWARDS FINDING STRATEGIES FOR
BOTH INTERVENTIONS AND
PREVENTION OF SO-CALLED LONG
COVID, OR PASC.
PATIENTS ARE AT THE ABSOLUTE
CENTER OF OUR EFFORTS.
WE UNDERSTAND THAT THEY ARE
SUFFERING FROM AN UNKNOWN
SYNDROME THAT IS NOT CLEARLY
CHARACTERIZED YET, ALTHOUGH
WE'RE WORKING VERY HARD TO
REDRESS THAT.
THE RECOVER PROGRAM IS DESIGNED
TO FIGURE OUT WHAT THE RISK
FACTORS ARE, THE DIFFERENT
PRESENTATIONS OF THE SYNDROME,
AND PROGRESSION OVER TIME SO WE
CAN IDENTIFY POSSIBLE TREATMENTS
TO HELP THOSE WHO ARE SUFFERING
FROM THESE SYMPTOMS.
IF I COULD HAVE THE NEXT SLIDE.
THESE ARE JUST SOME OF THE
ACCOMPLISHMENTS TO DATE, AND
THERE HAVE BEEN MANY.
FIRST AND NON-TRIVIAL, WE'VE
BUILT THE LARGEST DIVERSE AND
DEEPLY CHARACTERIZED COHORT OF
PATIENTS THAT EXISTS.
AND WE'RE DOING SO BY BUILDING A
DIVERSE COHORT THAT REPRESENTS
THE DISEASE AND SO WE HAD WORKED
VERY HARD AT INCLUSIVE AND
DIVERSE PARTICIPATION AND
COMMUNITY ENGAGEMENT.
WE'VE CREATED PLATFORM AND
MASTER PROTOCOLS TO HELP US
STANDARDIZE METHODOLOGIES AND
HARMONIZE DATA ACROSS ALL OF OUR
STUDIES, THROUGH COMMON DATA
ELEMENTS, AND AS SCIENCE EVOLVES
AND AS NEW INFORMATION BECOMES
AVAILABLE, WE AIM TO BE ADAPTIVE
AND SHAPE THE FUTURE OF THE
STUDY AS APPROPRIATE.
THE GUIDING PRINCIPLES HAVE BEEN
CONSISTENT THROUGHOUT THE STUDY,
AND THEY WILL CONTINUE TO SHOW
US THE WAY MOVING FORWARD.
AND, AGAIN, DR. GIBBONS WILL
PRESENT A VERY THOROUGH SUMMARY
OF ALL OF THE EFFORTS BUT I DID
WANT TO AT LEAST MENTION THIS IN
MY OPENING REMARKS.
NEXT SLIDE PLEASE.
I DIDN'T WANT TO LEAVE A COVID
UPDATE WITHOUT QUICKLY
SUMMARIZING SOME OF THE ACTIV
EFFORTS.
WE STOOD THIS UP OF COURSE IN
2020.
IT WAS A PUBLIC/PRIVATE
PARTNERSHIP TO COORDINATE
RESEARCH STRATEGY FOR
PRIORITIZING AND SPEEDING
DEVELOPMENT OF TREATMENTS AND
VACCINES.
IT REALLY PROVIDED A FORUM FOR
RAPID AND OPEN EXCHANGE OF IDEAS
AMONG THE GOVERNMENT, INDUSTRY,
ACADEMIA.
WE EMPLOYED EXISTING TRIAL
NETWORKS, BOTH IN U.S. AND
INTERNATIONALLY.
TREMENDOUS AMOUNT OF IMPACT.
STILL ONGOING TRIALS, AS YOU CAN
SEE HERE, WHICH WE'LL BE
FINISHING UP OVER THE NEXT YEAR.
IF I COULD HAVE THE NEXT SLIDE
PLEASE.
HERE ARE OUTPUTS, ENROLLED
23,000 PATIENTS, OVER 300 SITES.
MANY, MANY PUBLICATIONS HAVE
BEEN WELL CITED.
NEXT PLEASE.
WE REVIEWED OVER 800 AGENTS, 34
AGENTS AND COMBINATIONS WERE
TESTED.
TURNED OUT THAT 6 PROVED
EFFICACIOUS.
AS THE VIRUS EVOLVED, SOME WERE
NO LONGER USEFUL, BUT THIS OF
COURSE IS WHAT YOU ARE DEALING
WITH, WITH A RAPIDLY EVOLVING
RNA VIRUS.
AND I WOULD JUST LIKE TO THANK
ALL OF THE ACTIV LEADERSHIP TEAM
AND DR. GERBERDING WHEN SHE
PRESENTS MAY TOUCH UPON THIS BUT
I ESPECIALLY WANT TO THANK OUR
COLLEAGUES AT THE FNIH FOR ALL
THAT THEY DID IN HELPING US.
NEXT PLEASE.
JUST A COUPLE ADDITIONAL
INITIATIVES, VERY QUICKLY
BECAUSE I'M A LITTLE BEHIND
TIME.
NEXT PLEASE.
DR. BERTAGNOLLI WILL PROVIDE A
COMPREHENSIVE VIEW OF THE
MOONSHOT BUT, AGAIN, IF THERE'S
SOMEBODY ONLY TUNING IN FOR THE
DIRECTOR'S REPORT I DID WANT TO
MENTION THIS.
VERY BOLD AND IMPORTANT
INITIATIVE, IT BUILDS UPON THE
CANCER MOONSHOT IN 2016 THAT
SUPPORTED OVER 250 RESEARCH
PROJECTS, OVER 70 PROGRAMS AND
CONSORTIA.
THE GOALS FOR THE MOONSHOT
LAUNCHED BY THE PRESIDENT IN
FEBRUARY OF 2022 ARE AGAIN
AMBITIOUS, TO REDUCE CANCER
DEATH RATE BY 50% OVER THE NEXT
25 YEARS, AND TO IMPROVE THE
EXPERIENCE OF PEOPLE AND THEIR
FAMILIES LIVING WITH AND
SURVIVING CANCER.
AND AGAIN, DR. BERTAGNOLLI WILL
GIVE YOU THE DETAILS OF THIS.
NEXT PLEASE.
DR. AVENEVOLI WILL TALK ABOUT
THE MENTAL HEALTH CRISIS AND
WHAT NIH IS DOING ABOUT IT.
AGAIN, I DIDN'T WANT THIS
DIRECTOR'S REPORT TO GO WITHOUT
AT LEAST ME MENTIONING THIS,
GIVEN THE URGENT NATIONAL CRISIS
WE HAVE WITH YOUTH MENTAL
HEALTH, SADLY THE RATE OF
SUICIDE IS INCREASING AMONG
YOUTH INCLUDING PRE-TEENS,
EXACERBATED AMONG RACIAL AND
ETHNIC MINORITY.
SURGEON GENERAL'S OFFICE ISSUED
ADVISORIES, AND WE'RE OF COURSE
SUPPORTING A GREAT DEAL OF
RESEARCH IN THIS EFFORT AND,
AGAIN, LOOK FORWARD TO HEARING
FROM DR. AVENEVOLI LATER TODAY
ON ADDRESSING THE MENTAL HEALTH
CRISIS THROUGH RESEARCH.
AMP, WHICH DR. GERBERDING MAY
TOUCH UPON, IS EXTREMELY ACTIVE,
ACCELERATING MEDICINES
PARTNERSHIP WHICH THE FOUNDATION
FOR NIH HELPS CATALYZE.
TEN PROJECTS NOW, OVER $800
MILLION IN INVESTMENTS, WITH
OVER 34 INDUSTRY PARTNERS, 37
NOT FOR PROFITS.
THIS IS REALLY BECOMING A
PARADIGM OF BEING ABLE TO DO
CUTTING-EDGE WORK, AND WE ARE
VERY, VERY GRATEFUL FOR THE HELP
OF THE FOUNDATION AND ALL OF OUR
PARTNERS BOTH INDUSTRY,
NOT-FOR-PROFITS, AND THOSE HERE
AT NIH.
WE HAVE PROJECTS RELATED TO
THINGS SUCH AS AUTOIMMUNE
DISEASE, ALZHEIMER'S DISEASE,
GENE THEY WERE AND MANY SURE.
SHE WILL TOUCH UPON THAT.
NEXT SLIDE PLEASE.
AS ANYBODY HERE ON THE EAST
COAST WHO IS EXPERIENCING THE
SMOKY SKIES TODAY CAN ATTEST,
THE RISK OF CLIMATE CHANGE IS
REAL AND I SUSPECT OUR
COLLEAGUES ON THE WEST COAST
COULD HAVE TOLD US A LONG TIME
AGO ABOUT THAT.
WE DO HAVE THIS NIH-WIDE
COLLABORATIVE INITIATIVE ON
CLIMATE CHANGE AND HEALTH, WHICH
IS OUTLINED HERE.
AND THIS INITIATIVE REALLY IS
DESIGNED TO BUILD A
COLLABORATIVE COMMUNITY ENGAGING
POLICYMAKERS, INDUSTRY,
TECHNOLOGY LEADERS, DIVERSE
COMMUNITIES, OTHER STAKEHOLDERS,
FOUR CORE ELEMENTS, HEALTH
EFFECTS RESEARCH, HEALTH EQUITY
RESEARCH, INTERVENTION RESEARCH,
AND TRAINING AND CAPACITY
BUILDING.
THIS IS LED BY DR. WOYCHEK,
HELPED BY SEVEN INSTITUTE AND
CENTER DIRECTORS.
SLIDE 41, NEXT SLIDE.
JUST TO SHARE A COUPLE QUICK
UPDATES FROM OUR NIH HELPING TO
END ADDICTION LONG TERM, SO
CALLED HEAL INITIATIVE.
THIS IS AN AGGRESSIVE NIH-WIDE
EFFORT TO SPEED SCIENTIFIC
SOLUTIONS TO STEM, CONTINUING
CRISIS IN OPIOID USE DISORDER.
MOST INSTITUTES AND CENTERS ARE
INVOLVED.
AS YOU CAN SEE FROM THE SUMMARY
SLIDE HERE, OVER $2.5 BILLION IN
RESEARCH, OVER 1,000 RESEARCH
PROJECTS, VERY IMPORTANTLY OVER
300 CLINICAL TRIALS ARE ONGOING.
WITH 41 FDA APPROVALS FOR
INVESTIGATIONAL NEW DRUGS OR
DEVICES.
THIS IS ONGOING WITH
PARTNERSHIPS WITH FEDERAL
AGENCIES, PRIVATE SECTOR,
ACADEMIA AND COMMUNITIES.
NEXT PLEASE.
"HEAL" IS MAKING A DIFFERENCE.
FOR EXAMPLE, THERE'S NOW A NEW
STANDARD OF CARE FOR INFANTS
BORN DEPENDENT ON OPIOIDS.
RECENTLY, IN COLLABORATION WITH
THE BRAIN INITIATIVE, A PATIENT
SIGNATURE BRAIN SIGNATURE WAS
IDENTIFIED IN THOSE WITH CHRONIC
PAIN.
ANOTHER EXAMPLE, THE SAFETY AND
EFFICACY OF BUPRENORPHINE USE IN
THE EMERGENCY DEPARTMENT WAS
DEMONSTRATED.
AND THIS IS EXTREMELY IMPORTANT
IN AN ERA WHERE FENTANYL IS JUST
SO WIDESPREAD.
AND THEN FINALLY OPIOID
ADDICTION HAS BEEN FOUND TO BE
REDUCING RECIDIVISM BY 30% IF
YOU TREAT THE ADDICTION WHILE
THE INDIVIDUAL IS INCARCERATED.
NEXT PLEASE.
WITH THAT, WITH APOLOGIES TO MY
COLLEAGUES, FOR BEING A LITTLE
BIT OVER TIME, I THINK WE'LL GET
US BACK ON TRACK, I'M GOING TO
ASK FOR BUDGET AND LEGISLATIVE
UPDATES.
SO WE'LL START WITH NEIL SHAPIRO
FOR THE FORMER AND TURN TO
LAUREN HIGGINS FOR THE LATTER.
SO NEIL, TAKE IT AWAY.
NEXT SLIDE.
>> THANK YOU.
CAN YOU HEAR ME?
LET'S GO TO THE NEXT SLIDE
PLEASE.
LET ME START WITH WHERE WE ARE
ON FISCAL YEAR 2023, CURRENT
YEAR.
WE RECEIVED OUR FULL YEAR
APPROPRIATION ON DECEMBER 29,
AFTER THREE CONTINUING
RESOLUTIONS.
THE FUNDS ARE SUPPOSED TO ARRIVE
BY SEPTEMBER 30.
THAT RARELY HAPPENS.
LAST YEAR IT TOOK UNTIL MARCH
15, SO DECEMBER 29 WAS AN
IMPROVEMENT.
AND IN THAT BILL WE RECEIVED OUR
FULL YEAR DISCRETIONARY
APPROPRIATION AS WELL AS
AUTHORIZATION LANGUAGE FOR
ARPA-H, AS AN INDEPENDENT
ENTITY, SUBJECT TO DEBATE
WHETHER IT SHOULD BE PART OF NIH
OR NOT.
CONGRESS IN THIS OMNIBUS BILL
INCLUDED THAT LANGUAGE TO PUT IT
WITHIN NIH.
AND THEN THE ADMINISTRATION HAD
REQUESTED A PANDEMIC
PREPAREDNESS PROPOSAL, THIS WAS
AN $82 BILLION PROPOSAL WHICH
NIH'S SHARE WAS ABOUT $12
BILLION.
AND THAT DID NOT GO THROUGH TO
PREPARE FOR FUTURE PANDEMICS,
AND WE ALSO DID NOT RECEIVE
ADDITIONAL EMERGENCY
SUPPLEMENTAL FUNDS FOR COVID-19
RESEARCH, AS PART OF THE 23
ACTION.
NEXT SLIDE.
SO HERE ARE SOME NUMBERS.
YOU CAN SEE WHETHER THEY CAME
OUT.
TOTAL INCREASE OVER THE PRIOR
FISCAL YEAR WAS $3 BILLION.
HALF OF THAT FOR ARPA-H, AND
$2.5 BILLION FOR THE REST OF
NIH.
THE PERCENTAGE, 6.5% OVERALL,
WITHOUT ARPA-H 5.5%, SO ANOTHER
HEALTHY INCREASE AFTER SEVERAL
YEARS IN WHICH CONGRESS HAS BEEN
ABLE TO GREATLY INCREASE THE NIH
BUDGET AND HELP US MAKE UP FOR
MANY YEARS BEFOREHAND WHERE OUR
PURCHASING POWER WAS REDUCED BY
INFLATION.
THE INSTITUTES AND CENTERS PART
OF THE 5.5%, RECEIVED 3.8%
GENERAL INCREASE, AND SPECIFIC
INCREASES FOR CERTAIN RESEARCH
AREAS.
AND ALSO GETTING BACK TO WHAT
LARRY SAID ABOUT THE 21ST
CENTURY CURES ACT, OF THOSE
BILLIONS OF DOLLARS THAT YOU MAY
HAVE NOTICED ON HIS SLIDE, THEY
WERE SPREAD OUT OVER SEVERAL
YEARS, DEPENDING ON THE PROJECT.
AND DISTRIBUTION OF FUNDS DIDN'T
MATCH PROGRAMMATIC NEEDS.
SO FISCAL 23, CURRENT YEAR IS A
PEAK YEAR FOR THE CURES ACT
FUNDING IN THIS INNOVATION
ACCOUNT, WHICH WAS PROVIDED IN
THE 21ST CENTURY CURES ACT, IT'S
THE FINAL YEAR OF FUNDING FOR
THE CANCER MOONSHOT, IN THAT
ACT.
BUT THE LEVELS FOR THE "ALL OF
US" RESEARCH PROGRAM AND BRAIN
INITIATIVE GO BACK DOWN IN 2024.
SO, WHAT HAS HAPPENED, THE
CONGRESS THIS YEAR AS WE
REQUESTED HAS BALANCED OUT THE
TWO SOURCES OF FUNDING, AND THEN
A REQUEST FOR 2024 IS TO KEEP
THOSE LEVELS AT THIS YEAR'S
AMOUNT WHICH I'LL GET INTO IN A
MOMENT.
NEXT SLIDE.
THIS IS A QUICK LIST OF THE
TARGETED INCREASES IN THE BILL.
THERE'S A CONTINUED RAMP-UP OF
FUNDING FOR ALZHEIMER'S DISEASE
RESEARCH, THIS YEAR SPLIT
BETWEEN NIA AND NINDS.
IN PRIOR YEARS HAD ALL GONE TO
NIA.
THERE WAS ADDITIONAL FUNDING FOR
NCI TO IMPROVE SUCCESS RATES
PAYLINES, HIV/AIDS RESEARCH,
NIH-WIDE RECEIVED AN INCREASE.
BUILDINGS AND FACILITIES VERY
CRITICALLY NEEDED $100 MILLION
INCREASE FOR THAT ACCOUNT.
AS WELL AS MORE THAN GENERAL
INCREASE FOR THE COMMON FUND,
AND ADDITIONAL INCREASES LISTED
HERE.
NEXT SLIDE.
I WANTED TO MENTION AS LARRY
TOUCHED ON WE CONTINUE TO
ADMINISTER EMERGENCY
SUPPLEMENTAL FUNDS FOR COVID-19,
OVER A TWO-YEAR PERIOD NIH
RECEIVED OVER $4.8 BILLION OF
FUNDING FOR COVID-19 RESEARCH,
IN ADDITION WE'VE BEEN
IMPLEMENTING BILLIONS OF DOLLARS
OF FUNDING FROM THE HHS PUBLIC
HEALTH AND SOCIAL SERVICES
EMERGENCY FUND.
UNDER DELEGATED AUTHORITIES SO
THOSE ARE SOME PROJECTS THAT NIH
IS ADMINISTRATION BUT THE
FUNDING WAS PROVIDED TO
DEPARTMENT RATHER THAN DIRECTLY
TO NIH.
I WANT TO MENTION A PROJECT
COLLABORATION WITH BARDA TO WORK
ON NEXT GENERATION OF COVID-19
VACCINES AND TREATMENTS, $5
BILLION INITIATIVE THAT JUST
LAUNCHED RECENTLY.
NEXT.
SO 2024 THE PRESIDENT'S BUDGET
AS WELL AS OMNIBUS CAME OUT
AFTER THE LAST ACD MEETING.
HERE THE PROPOSAL IS FOR
ADDITIONAL $1.9 BILLION OVER
FISCAL 23, THAT'S $1 BILLION TO
CONTINUE RAMPING UP ARPA-H, THE
OTHER $919 MILLION FOR THE REST
OF NIH.
AND IT INCLUDES -- THAT MONEY
PRIORITY INITIATIVES
PARTICULARLY THE CANCER MOONSHOT
WHICH I'LL MENTION IN A MOMENT,
BUT IN 2024 THERE ISN'T A
PROPOSAL TO INCREASE THE BASE
BUDGETS FOR THE INSTITUTES AND
CENTERS THAT WOULD REMAIN AT THE
2023 LEVEL.
IN ADDITION, THERE'S ANOTHER
PROPOSAL MANDATORY FUNDING,
SEPARATE FROM THE ANNUAL
DISCRETIONARY FUNDING.
FOR PANDEMIC PREPAREDNESS.
THIS IS A SCALED DOWN PROPOSAL.
TOTAL IS $20 BILLION RATHER THAN
82, NIH SHARE $2.6 BILLION
RATHER THAN 12.
WE'RE HOPE FUL WE MAY MAKE
PROGRESS WITH THE SCALED DOWN
REQUEST THIS YEAR.
NEXT.
SO AS I MENTIONED BEFORE, THERE
ARE INCREASES TO BASE FUNDING
BECAUSE OF THE 21ST CENTURY
CURES ACT PROPOSAL, BOTH "ALL OF
US" RESEARCH PROGRAM AND BRAIN
INITIATIVE WOULD STAY AT THE
TOTAL 2023 LEVEL SO FUNDING
SHIFTS BETWEEN THE TWO SOURCES,
BUT WE HAVE REQUESTED THAT THEY
NOT BE REDUCED WITH THE
INNOVATION FUNDS SCALING DOWN AS
WELL AS WITH CANCER MOONSHOT
BECAUSE THAT WAS A SEVEN-YEAR
PROFILE RATHER THAN TEN YEARS
LIKE THE OTHER TWO PROGRAMS, IN
2024 TO MAINTAIN THAT LEVEL THE
FUNDS WOULD NEED TO SHIFT FROM
THE INNOVATION ACCOUNT FUNDING
TO BASE FUNDING LIKE THE REST OF
THE BUDGET.
SO THE REQUEST FOR CANCER
MOONSHOT IS FOR $716 MILLION,
$216 MILLION WAS THE CURES ACT
LEVEL, 716 WOULD BE NON-CURES
FUNDING WITH $500 MILLION
INCREASE.
BUDGET ALSO PROPOSED
$1.5 BILLION.
THE OTHER TARGETED INCREASES
THAT I MENTIONED AS PART OF THAT
$900 MILLION, $200 MILLION
MENTAL HEALTH RESEARCH, $120
MILLION NUTRITION SCIENCE,
THAT'S A REPEAT OF THE 2023
INITIATIVE THAT SO FAR CONGRESS
HAS NOT SUPPORTED, AND ALSO
INCREASING OUR TYPE 1 DIABETES
MANDATORY FUNDING TO $250
MILLION FROM WHAT HAS BEEN $150
MILLION IN SOME YEARS GETS
REDUCED BY SEQUESTER WHICH IS
WHY WE NEED THE EXTRA $9 MILLION
THERE, AS PART OF THE TYPE 1
DIABETES FUNDS, THAT THIS YEAR
WAS PROVIDED BY CONGRESS AS BASE
FUNDING RATHER THAN MANDATORY.
AND NEXT.
FISCAL RESPONSIBILITY ACT OF
2023, AS YOU'VE HEARD ABOUT IN
THE NEWS, THIS IS THE DEBT
CEILING BILL.
IT INCLUDES TWO YEARS SUSPENSION
OF DEBT LIMIT SO WE WON'T BE
RENEGING ON COMMITMENTS, AND
TWO-YEAR BUDGET DEAL NON-DEFENSE
DISCRETIONARY SPENDING WHERE NIH
FITS IN THE BUDGET IS ROUGHLY
FLAT IN FISCAL 2024, INCREASING
1% IN 2025, CHALLENGING
APPROPRIATIONS SEASON, UP TO
CONGRESS HOW THEY CHOOSE TO LIVE
WITHIN THOSE LIMITS.
BUT IT DOES LOOK LIKE IT WILL BE
DIFFICULT TO MAINTAIN THE KIND
OF INCREASES THAT WE'VE RECEIVED
THE LAST SEVERAL YEARS IN 2024,
AND WE'LL CONTINUE TO WORK FOR
THE BEST POSSIBLE OUTCOME ON
THAT FRONT.
THERE'S A PROVISION IN THE BILL
INTENDED TO TRY TO PROVIDE
INCENTIVES FOR CONGRESS TO GET
APPROPRIATIONS BILL DONE AS
QUICKLY AS POSSIBLE.
THEY HAVE UNTIL THE END OF THE
CALENDAR YEAR, SO THIS YEAR,
THIS PAST SEASON, THEY MADE IT
BY THE END OF DECEMBER.
PRIOR YEAR NOT.
BUT IF THEY DON'T GET ALL THE
APPROPRIATIONS BILLS DONE BY
THAT DATE, THERE'S PROVISION
THAT REDUCES STATUTORY CAPS DOWN
TO 1% BELOW THE FISCAL 2023
LEVEL.
HOPEFULLY THAT WILL BE A VERY
STRONG INCENTIVE FOR CONGRESS TO
GET APPROPRIATIONS BILLS DONE ON
TIME AND NOT HAVE TO REDUCE THEM
FURTHER THAN THE 2024 CAP.
AND FINALLY IN THE BILL THERE'S
RESCISSION OF COVID SUPPLEMENTAL
APPROPRIATIONS.
IT IS IN THE BILLIONS OF
DOLLARS.
BUT LARGELY NOT DIRECTED TOWARDS
THE TYPES OF SPENDING THAT NIH
HAS BEEN DOING WITH OUR COVID
SUP FUNDS, THERE ARE EXEMPTIONS
THE ADMINISTRATION WILL BE
IMPLEMENTING.
I WOULD NOTE THAT OF THE
$4.8 BILLION NIH INITIALLY
RECEIVED, THERE'S VERY LITTLE
THAT HAS NOT BEEN OBLIGATED YET,
TO AWARD GRANT OR CONTRACT, FOR
EXAMPLE, WE WILL CONTINUE TO
IMPLEMENT RESEARCH FOR QUITE
SOME TIME IN TERMS OF AWARDS
WE'VE ALREADY MADE, BUT THIS
PROVISION WILL LIMIT THE AMOUNT
OF ADDITIONAL ACTIVITY THAT GOES
ON IN THIS AREA, SO WANTED TO
MAKE CLEAR THE RESCISSIONS WHILE
REDUCING FUNDING AVAILABLE TO
MAKE FURTHER AWARDS IS NOT
LIMITING THE RESEARCH THAT WE'RE
DOING WITH EXISTING AWARDS.
WITH THAT LET ME STOP.
>> OKAY.
THANKS VERY MUCH, NEIL.
LAUREN, IF WE COULD TURN TO YOU
NEXT PLEASE.
>> HELLO.
THANK YOU.
I'M LAUREN HIGGINS, GIVING THE
LEGISLATIVE UPDATE.
NEXT SLIDE PLEASE.
I WANT TO START WITH THE
EXCITING NEWS, WE HAVE A NOMINEE
FOR NIH DIRECTOR, THIS IS A
SENATE-CONFIRMED POSITION.
THEREFORE THERE'S A PROCESS
INVOLVED.
I THOUGHT I WOULD TOUCH UPON
THAT PROCESS.
I WANT TO MENTION THAT THE WHITE
HOUSE LEGISLATIVE OFFICE AND HHS
LEGISLATUREIVE OFFICE MANAGED
THIS PROCESS.
OUR OFFICE UNFORTUNATELY IS NOT
INVOLVED.
THE PRESIDENT ANNOUNCED THE
NOMINEE IN MAY.
AND DR. BERTAGNOLLI, CURRENT NI
DIRECTOR, HAS BEGUN MEETING WITH
A LARGE NUMBER OF SENATORS OVER
THE NEXT COUPLE MONTHS.
THE SENATE HEALTH COMMITTEE, NIH
AUTHORIZING COMMITTEE, WILL HOLD
A HEARING ON THE NOMINATION.
AND THEN THE COMMITTEE WILL HAVE
A VOTE ON THE NOMINATION.
ONCE THAT HAPPENS, IT GOES --
NOMINATION GOES TO THE SENATE
FLOOR, AND AT ANY TIME THE
SENATE CAN CALL IT UP FOR A
VOTE.
SO, THE PROCESS LOOKS EASY ON
PAPER.
WE HOPE IT GOES SMOOTHLY.
WE LOOK FORWARD TO WORKING WITH
HER ONCE SHE'S CONFIRMED.
THANK YOU.
THE NEXT SLIDE PLEASE.
I'M GOING TO GO FAST.
I THINK WHEN ADRIAN GAVE THE
LAST UPDATE IN DECEMBER WE KNEW
THAT REPUBLICANS HAD JUST TAKEN
THE MAJORITY FOR THE HOUSE, THAT
SWITCHED.
IN THE SENATE DEMOCRATS REMAINED
IN CONTROL AND HAD ACTUALLY
GAINED A SEAT SO THEY HAD A
MAJORITY OF 51.
SO THE SPEAKER OF THE HOUSE IS
ACTUALLY VOTED ON BY THE FULL
HOUSE, AND IT TOOK 15 BALLOTS
OVER FOUR DAYS TO ELECT SPEAKER
McCARTHY.
GIVEN THE SMALL MARGIN, WE SAW
IT PLAY OUT, AND JUST FOR SOME
TRIVIA CONTEXT, PRIOR TO THIS
CONGRESS THERE WERE 14 TIMES
THAT THE SPEAKER'S RACE TOOK
MORE THAN ONE BALLOT, 13
OCCURRED BEFORE THE CIVIL WAR.
THE LAST TIME WAS IN 1923, IT
TOOK NINE BALLOTS.
IN THE HOUSE LEADERSHIP WE SAW A
GENERATIONAL SWITCH WHEN SPEAKER
PELOSI AND STENY HOYER STEPPED
DOWN FROM THEIR LEADERSHIP ROLES
AND HAKEEM JEFFRIES AND
KATHERINE CLARK OF MASSACHUSETTS
STEPPED INTO THOSE LEADERSHIP
ROLES.
IN THE SENATE, CHUCK SCHUMER
MAJORITY LEADER, MITCH
McCONNELL AS MINORITY LEADER,
THEY HAVE BEEN THE LEADERS FOR
THE LAST COUPLE CONGRESSES IN
THE SENATE.
I MENTIONED THE SLIM MAJORITIES
IN HOUSE AND SENATE.
WHAT THIS DOES IS EMPOWERS
MEMBERS OR SMALL CAUCUSES OF
MEMBERS TO HAVE A LITTLE BIT
MORE POWER ON HOW LEGISLATION
MOVES.
WE'RE SEEING THAT PLAY OUT IN
REAL TIME RIGHT NOW.
WITH THE DEBT LIMIT BILL,
SPEAKER McCARTHY NEGOTIATED
WITH THE WHITE HOUSE, A NUMBER
OF REPUBLICANS WERE NOT HAPPY,
IT TOOK DEMOCRATIC VOTES TO
ADVANCE THE DEBT LIMIT BILL AND
BRING TO A FINAL VOTE.
IN THE HOUSE.
IT WAS BECAUSE OF DEMOCRATIC
VOTES THAT IT PASSED THE HOUSE.
SO, HIS MEMBERS THAT WERE
UNHAPPY ARE CURRENTLY REVOLTING,
THEY ARE SAYING IN THE PRESS,
AND VOTES THIS WEEK TO MOVE
LEGISLATION AND THESE ARE
REPUBLICAN PRIORITIES, HAVE COME
TO A STANDSTILL, THEY ARE VOTING
AGAINST ADVANCING LEGISLATION.
AND LAST NIGHT THEY THOUGHT
THEY -- THIS HAPPENED TUESDAY
NIGHT.
THEY THOUGHT YESTERDAY THEY
COULD NEGOTIATE A WAY OUT TO
ADVANCE THESE BILLS.
BUT LAST NIGHT IT BROKE DOWN AND
THERE WILL BE NO MORE VOTES IN
THE HOUSE UNTIL NEXT WEEK.
NEXT SLIDE PLEASE.
AND NOW TO OUR COMMITTEES, WE
HAVE NEW LEADERSHIP HERE AS
WELL.
SENATOR BERNIE SANDERS OF
VERMONT IS OUR NEW CHAIR OF THE
HEALTH EQUITY, OUR AUTHORIZING
COMMITTEE.
RANKING MEMBER BILL CASSIDY OF
LOUISIANA IS OUR NEW RANKING
MEMBER.
BOTH HAVE BEEN LONGTIME MEMBERS
OF THE HEALTH COMMITTEE.
AND BERNIE SANDERS CAME TO NIH
FIRST WEEK AS CHAIR JANUARY 6,
GAVE US TWO DAYS' NOTICE BUT I
THINK IT WENT WELL, AS MOST OF
YOU KNOW HIS BIG PRIORITY IS
DRUG PRICING.
HE'S ALSO INTERESTED IN AGING
RESEARCH AND DISABILITY
RESEARCH.
SENATOR CASSIDY'S INTERESTED IN
MENTAL HEALTH AND HE HAS BEEN
VERY VOCAL ABOUT HOW BURDEN OF
DISEASE SHOULD HAVE SOME IMPACT
ON OUR FUNDING DECISIONS.
NEXT SLIDE PLEASE.
HOUSE SIDE WE HAVE BECAUSE THE
HOUSE, REPUBLICANS TOOK
MAJORITY, CATHY MCMORRIS ROGERS
WHO WAS RANKING MEMBER IN LAST
CONGRESS BECAME OUR FULL
COMMITTEE CHAIR.
AND FRANK PALLONE, LONGTIME
CHAIR, BECAME RANKING MEMBER.
CHAIR RODGERS PRIORITIES ARE
DOWN SYNDROME, NIH REFORM, AND
OVERSIGHT OF SHOVED RESPONSE.
PALLONE HAS BEEN INTERESTED IN
SUDDEN INFANT DEATH SYNDROME,
CLINICAL TRIALS REPORTING, 21ST
CENTURY CURES.
APPROPRIATIONS, FIRST I WANT TO
MENTION FOR THE FIRST TIME THE
FULL COMMITTEE CHAIRS IN BOTH
SENATE AND HOUSE ARE WOMEN.
LONGTIME SUBCOMMITTEE CHAIR
PATTY MURRAY OF WASHINGTON WAS
ALSO OUR HEALTH COMMITTEE CHAIR
FOR MANY YEARS, NOW FULL CHAIR,
CHAIR OF FULL COMMITTEE OF
APPROACH RIGSES, AND SUSAN
COLLINS OF MAINE IS RANKING
MEMBER.
IN THE HOUSE SIDE,
REPRESENTATIVE KAY GRANGER IS
THE NEW CHAIR, AND RANKING
MEMBER ROSE DELAURO, EXCITED TO
SEE FOUR WOMEN IN THOSE POWERFUL
ROLES.
BUT FOR OUR SUBCOMMITTEE WHO WE
WORK WITH MORE CLOSELY WE HAVE
TAMMY BALDWIN, WISCONSIN, NEW
SUBCOMMITTEE CHAIR, SHE AND
SHELLY MOORE CAPITO, RANKING
MEMBER BOTH ON SUBCOMMITTEE FOR
A LONG TIME AND ARE MEMBERS WHO
ARE VERY INTERESTED IN NIH
RESEARCH.
NEXT SLIDE PLEASE.
NOW ON THE HOUSE SIDE, ROBERT
ADERHOLT OF ALABAMA IS OUR NEW
SUBCOMMITTEE CHAIR, TOM COLE WHO
HAD BEEN OUR REPUBLICAN LEADER,
APPROPRIATIONS SUBCOMMITTEE,
MOVED OFF TO A DIFFERENT
SUBCOMMITTEE.
SO WE WERE SORRY TO SEE HIM GO
BUT GETTING TO KNOW CHAIR
ADERHOLT AND ROSA DELAURO, WHO
HAS BEEN CHAIR OR RANKING MEMBER
IS NOW THE RANKING MEMBER,
WORKING WITH HER FOR A LONG
TIME.
NEXT SLIDE PLEASE.
SO, SNAPSHOT OF ACTIVITIES,
THREE HEARINGS, IN ADDITION TO
TWO APPROPRIATIONS COMMITTEE
HEARINGS, WE HAD ONE COMMERCE
COMMITTEE OVERSIGHT HEARING, DR.
TABAK APPEARED ALONG WITH FDA
DIRECTOR AND CDC DIRECTOR
ROCHELLE WALENSKY, TWO
APPROPRIATIONS COMMITTEE
HEARINGS THE HOUSE HEARING WAS
DIFFERENT THIS YEAR.
WE NORMALLY HAVE OUR HEARINGS
WHERE THE NIH DIRECTOR GOES UP
WITH FOUR OR FIVE INSTITUTE
DIRECTORS, ON THE HOUSE SIDE IT
WAS A COMBINATION, BUDGET
HEARING AND COVID OVERSIGHT
HEARINGS.
DR. TABAK WAS A WITNESS ALONG
WITH THE DIRECTOR OF CDC, AND
ASPR DIRECTOR.
SENATE SIDE, NORMAL HEARING, DR.
TABAK ACCOMPANIED BY DR.
GORDONEN, RICHARD HODES, ACTING
DEPUTY DIRECTOR FOR NCI DOUG
LOWY, AND NIDA DIRECTOR NORA
VOLKOW.
WE HOSTED FOUR VISITS SO FAR,
MORE COMING UP.
CONGRESS IS BACK IN BUSINESS.
NIH IS OPEN.
WE'RE VERY EXCITED.
WE'VE HAD FIVE ROUNDTABLES, 79
BRIEFINGS, 55 REQUESTS FOR
INFORMATION.
APPROPRIATIONS, I MENTIONED THAT
WE HAD TWO APPROPRIATIONS
HEARINGS, THESE ARE THE MAJORITY
OF THE THEMES THAT WE HEARD
MEMBERS ASK ABOUT.
EARLY-STAGE INVESTIGATORS,
NUMBER ONE.
ALZHEIMER'S DISEASE, YOUTH
MENTAL HEALTH, CHILDHOOD CANCER,
FENTANYL AND OPIOIDS, ARPA-H
FUNDING, CHILDREN AND
TECHNOLOGIES, AND COVID-19
RESPONSE.
THOSE WERE THE THINGS WE'VE BEEN
HEARING FROM CONGRESS ABOUT
WHICH IS NO SURPRISE.
OKAY, NEXT SLIDE.
LOOKING FORWARD, NOW THAT THE
DEBT LIMIT BILL GOT PASSED,
CONGRESS CAN GET TO WORK ON
OTHER THINGS, THAT WAS THE FOCUS
AND THERE WASN'T A LOT GOING ON.
SOME OF THE MUST HAVE
LEGISLATION, THESE ARE A LOT OF
BILLS EVEN IF THEY DON'T INVOLVE
NIH.
AND NIH-RELATED PROVISIONS COULD
GET ADDED.
THE FDA USER FEE PROGRAMS, THE
PANDEMIC AND ALL-HAZARDS
PREPAREDNESS ACT WHICH EXPIRES
END OF SEPTEMBER.
THEN APPROPRIATIONS BILLS, IF
THOSE DON'T PASS THEN THERE'S
THAT SEQUESTRATION SO I THINK
CONGRESS WILL BE MOTIVATED TO
PASS THE INDIVIDUAL BILLS THIS
YEAR OR GET AN OMNIBUS.
AND THEN THE NDAA, THE DEFENSE
AUTHORIZATION BILL, ALWAYS
GOVERNMENT-WIDE PROVISIONS WE
SEE.
WE COULD EXPECT ANOTHER
OVERSIGHT HEARING AT ANY TIME.
THANK YOU.
>> THANKS FOR THE REPORTS.
WITH APOLOGIES ON ME, I TOOK TOO
LONG, WE'VE KIND OF EATEN INTO
YOUR BREAK TIME.
I DO WANT TO OPEN UP FOR ANY
QUESTIONS THAT THE COUNCIL MAY
HAVE.
AND OBVIOUSLY, IF YOU NEED TO
TAKE A QUICK BREAK, PLEASE DO
SO.
AND COME RIGHT BACK.
KNOW WE BUILT IN TIME FOR
DISCUSSION DURING THE NEXT
PRESENTATION SO WE MAY STEAL A
LITTLE OF THAT TIME DEPENDING
UPON HOW MANY QUESTIONS THERE
ARE.
IF WE COULD HAVE THE FULL SCREEN
SO WE CAN SEE ALL THE
PARTICIPANTS PLEASE.
AND ACKNOWLEDGE THOSE WHO ARE
RAISING THEIR HAND FOR
QUESTIONING.
GREAT, THANK YOU.
SHELLEY, WHY DON'T YOU LEAD OFF.
>> THANK YOU, LARRY.
I WANT TO THANK YOU FOR THE
OPPORTUNITY TO SERVE ON THE
COMMITTEE, THANKING YOU AND DR.
COLLINS FOR THAT, IT'S BEEN A
PLEASURE.
JUST WANTED TO SAY THAT BEFORE I
GO ON.
I DID HAVE A QUESTION.
I DON'T KNOW HOW MUCH IN THE
WEEDS WE WANT TO GET HERE, BUT I
DID HAVE A QUESTION ABOUT THE
SIMPLIFICATION OF REVIEW
CRITERIA THAT YOU DISCUSSED.
AND I'M PARTICULARLY -- IT'S
SOMETHING -- WE HAD A
PRESENTATION LAST TIME, ON THE
THIRD FACTOR, INSTITUTION AND
INVESTIGATOR, THE DECISION NOT
TO SCORE.
I JUST WONDERED, YOU MENTIONED
THAT THERE WAS A MINORITY
REACTION IN THE RFI, I WONDERED
IF THERE WAS MORE DETAIL ABOUT
TAKING THOSE APART BECAUSE I
THINK IT'S QUITE DIFFERENT,
INSTITUTION, AND INVESTIGATOR,
ABOUT WHETHER THEY SHOULD BE
SCORED AND JUST TO FINISH MY
ENTIRE QUESTION, WONDERING IF
THERE IS ANY FURTHER DEEP
THINKING ABOUT THE SCORING OF
INVESTIGATOR, FOR EXAMPLE, MAYBE
ESI NOT TO SCORE BUT PAST THAT
TIME TO SCORE, YOU KNOW, JUST
WONDERING IF THERE'S ANY DEEPER
THOUGHT ABOUT THIS BECAUSE I
DON'T THINK IT'S A TRIVIAL
DECISION.
>> THANKS FOR THE QUESTIONS.
THIS IS SOMETHING VERY IMPORTANT
TO THE AGENCY.
I WONDER, MIKE LAUER, IF YOU
WANT TO ADDRESS THE QUESTIONS,
YOU'RE CLOSER TO SPECIFICS THAN
I AM.
>> WE PUT OUT A BLOG WHICH I
THINK LARRY ALLUDED TO, ON
RESULTS OF RFI, MAJORITY OF
RESPONDENTS LARGELY AGREED WITH
THE PROPOSAL AS IT WAS THERE.
BUT THERE WERE PEOPLE WHO DID
EXPRESS SOMETHING SIMILAR TO
WHAT YOU'RE SUGGESTING, SHELLEY,
THAT ENVIRONMENT AND
INVESTIGATORS SHOULD BE SCORED
AS OPPOSED TO THE WAY ORIGINALLY
SHOWN.
THIS IS SOMETHING WE'RE
CURRENTLY WORKING OUR WAY
THROUGH.
>> THANK YOU VERY MUCH.
>> OTHER QUESTIONS FROM MEMBERS
OF THE COUNCIL PLEASE?
I FEAR I'VE ANESTHETIZED
EVERYBODY.
WELL, OKAY.
I'M GOING TO TAKE THE VOTE OF
NON-QUESTION TO MEAN THAT WE
SHOULD MOVE ON NOW.
WE ARE ONE MINUTE INTO THE NEXT
SESSION, SO AGAIN WITH MY
APOLOGIES I'M GOING TO MOVE
FORWARD BECAUSE WE WANT TO KEEP
ON SCHEDULE.
OBVIOUSLY PLEASE STEP AWAY IF
YOU NEED TO.
MIKE HAS PUT INTO THE CHAT BOX
THE LINK TO HIS BLOG.
AND THOSE WHO WANT ADDITIONAL
DETAIL, PLEASE INTERROGATE THAT
SITE FOR THAT INFORMATION.
LET ME TURN THIS NOW TO TARA,
WHO WILL LEAD US THROUGH THE
REST OF THE AGENDA.
PLEASE TAKE IT AWAY.
>> THANKS, LARRY.
I'LL TAKE A MOMENT BECAUSE WE'RE
OVER TIME.
I WANT TO INTRODUCE DR. LYRIC
JORGENSON, OUR ACTING ASSOCIATE
DIRECTOR FOR SCIENCE POLICY, TO
GIVE US AN OVERVIEW OF SOME OF
THE ACTIVITIES THAT SHE'S BEEN
WORKING ON, HER TEAM HAS BEEN
WORKING ON, OTHERS ACROSS NIH ON
THE NIH PUBLIC ACCESS PLAN
COORDINATING WITH THE WHITE
HOUSE AND OTHERS.
WITH THAT, LYRIC, I'LL TURN IT
OVER TO YOU.
>> THANKS, TARA.
I'LL SHARE MY SCREEN WITH YOU
ALL TO GO OVER TODAY'S
PRESENTATION.
CAN YOU CONFIRM YOU CAN SEE IT?
>> YEP, WE CAN SEE AND HEAR
YOU.
>> PERFECT.
THANKS.
GREETINGS TO EVERYONE.
GOOD MORNING.
FOR THOSE NEW TO ACD, I'M LYRIC
JORGENSON
OVERSEE NIH POLICY EFFORTS.
I LAST MET WITH YOU ALL IN
DECEMBER WITH MY COLLEAGUE DR.
SUSAN GREGURICK, DR. LAUER AND
DR. BRENNAN TO PROVIDE YOU WITH
AN INTEGRATED VISION FOR NIH
OPEN DATA ECOSYSTEM.
TODAY I'M PLEASED TO GIVE AN
UPDATE ON ONE OF THE SIGNIFICANT
EFFORTS RELATED TO THIS
DECISION, SPECIFICALLY REGARDING
INCREASING EQUITABLE ACCESS TO
RESEARCH RESULTS.
IN PARTICULAR, RESEARCH
PUBLICATION.
THREE GOALS, FIRST TO DISCUSS
IMPETUS FOR PROMOTING ACCESS TO
RESEARCH RESULTS, ACD MEMBERS
ARE ON THE FRONT LINE THERE'S
VALUE IN REITERATING IMPORTANT
DRIVERS UNDERLYING NIH DECISION
MAKING HERE.
SECOND, WOULD LIKE TO DISCUSS
WITH ACD NIH PUBLIC ACCESS PLAN,
WHERE WE ARE ON THE TIMELINE FOR
UPDATING OUR PUBLIC ACCESS
POLICY.
FINALLY I'M HOPING THIS
PRESENTATION STIMULATES A
DISCUSSION AMONGST ACD, LEADERS
IN THE SETTINGS THAT CAN HELP US
THINK THROUGH THE INCENTIVES
WE'RE GOING TO NEED TO PUT IN
PLACE TO ESTABLISH THE ACTUAL
VISION OF OPEN DATA ECOSYSTEM.
I WANT TO REMIND THOSE TUNING IN
WHY ARE WE DISCUSSING THIS
IMPORTANT SET OF ISSUES.
FIRST, THROUGHOUT THE GOVERNMENT
THERE ARE NUMEROUS EFFORTS
UNDERWAY WITHIN AND ACROSS
AGENCIES, ACROSS RESEARCH
FUNDERS TO PROMOTE ACCESS TO
BOTH RESEARCH DATA AND RESEARCH
PUBLICATIONS.
NIH HAS BEEN A LEADER FOR SOME
TIME.
WE DISCUSSED SOME OF THIS IN
DECEMBER.
NIH HAS SUPPORTED ACCESS TO
RESEARCH DATA AND PUBLICATIONS,
WE ALL KNOW THIS.
IT'S IMPORTANT FOR ADVANCING NEW
SCIENTIFIC DISCOVERIES AND
STIMULATING NEW TYPES OF
INQUIRIES, IMPORTANT FOR RAPID
DISSEMINATION WHICH ALLOWS FOR
NEW KNOWLEDGE TO REACH HEALTH
PRACTICE FASTER AND EQUITABLY,
IMPORTANT FOR BUILDING
TRUSTWORTHINESS IN THE
SCIENTIFIC ENTERPRISE ITSELF.
THESE BENEFITS CAN ONLY BE
REALIZED IF SCIENTISTS TO DO THE
THE WORK TO MAKE THIS A REALITY.
CHANGE IN PRACTICE AFFECTS
RESEARCHERS, WE NEED TO BE
THOUGHTFUL ABOUT MAKING CHANGES
MEANINGFUL.
THIS IS AN OLDER SLIDE, BUT TWO
POINTS IN DECEMBER FOR CONTEXT.
PERHAPS MOST TIMELY EXAMPLE OF
WHY NIH AND THE SCIENTIFIC
COMMUNITY AT LARGE IS WORKING
TOWARDS OPEN DATA ECOSYSTEM HAS
BEEN WHAT WE'VE BEEN ABLE TO
ACHIEVE IN COMBATING OF THE THE
COVID PANDEMIC.
IT TOOK 40 YEARS TO GET A POLIO
VACCINE, 11 MONTHS FROM
ISOLATION OF THE SEQUENCE TO
FORMER NIH GETTING VACCINATED,
11 MONTHS.
ON THE RIGHT IT SHOWS HOW
IMPORTANT ACCESS TO RESEARCH
PRODUCTS WERE TO ENABLING THIS
FEAT.
RESEARCH COMMUNITY AT THE TIME
THE SLIDE WAS CREATED CREATED D
PAPERS IN PUBLIC MED CENTRAL,
150,000, MORE RECENT ESTIMATES
CLOSER TO 500,000 INDICATING HOW
IMPORTANT RESEARCH SHARING HAS
BEEN.
NEXT POINT, IMPORTANCE OF
TRANSPARENCY IN RESEARCH ITSELF.
PUBLISHED BY THE PEW
ORGANIZATION, RESPONDENTS WERE
ASKED FOUR QUESTIONS.
I CONTINUE TO BE FASCINATED.
MORE THAN HALF OF AMERICANS SAY
THEY TRUST RESEARCH FINDINGS
MORE IF DATA IS SET AND STUDY IS
OPENLY AVAILABLE TO THE PUBLIC.
INTERESTINGLY THE INFLUENCE OF
GOVERNMENT FUNDING IS LESS
CLEAR.
ABOUT A QUARTER SAY IT MAKES
FINDING MORE TRUSTWORTHY, A
QUARTER LESS, ABOUT HALF SAY IT
MAKES ABSOLUTELY NO DIFFERENCE.
AGAIN, STUDY IS PART OF A
GROWING BODY OF EVIDENCE
SUPPORTING THE HYPOTHESIS THAT
ACCESS TO OPEN DATA AND
INDEPENDENT REVIEW OF RESEARCH
RESULTS INCREASES PUBLIC
CONFIDENCE IN RESEARCH FINDINGS.
I KNOW THIS IS A TOPIC THAT
WE'VE BEEN DISCUSSING FOR SOME
TIME GIVEN THE GROWING INTEREST
IN THE CURRENT STATE
OFINFORMATION.
RECENT SUCCESS OF OPEN DATA
ECOSYSTEM PROMPTED NIH TO STEP
BACK AND TAKE A HOLISTIC
PERSPECTIVE.
THIS IS COMPLEX.
WE PRESENTED THIS TO THE ACD AND
NIH PROGRESS ON CERTAIN EFFORTS
BACK IN DECEMBER.
AT THE END OF THE DAY THE POINT
WE'RE TRYING TO MAKE IS WE
BELIEVE SCIENTIFIC ADVANCES ARE
MORE LIKELY AS THEY FLOW THROUH
THE PIPELINE RATHER THAN
DISCRETE MOMENTS IN TIME.
NIH PUT OUT POLICIES TO HELP
FACILITATE FLOW OF INFORMATION,
WE'VE HAD NUMEROUS EFFORTS OVER
THE COURSE OF SEVERAL DECADES TO
ACHIEVE DECISIONS.
TODAY WHAT WE WANT TO TALK ABOUT
IS UPDATE ON 2008 PUBLIC ACCESS
POLICY, RESEARCH PUBLICATIONS SO
WE CAN WORK IN TANDEM WITH THE
RESEARCH COMMUNITY.
AS I MENTIONED IN DISEASE THE
NEWS OF THE WHITE HOUSE ISSUING
NEW DIRECTIVE FOCUSED ON
ENSURING FREE, IMMEDIATE,
EQUITABLE ACCESS TO FEDERALLY
FUNDED RESEARCH, PROMOTE PRIOR
WORK ON THE MOONSHOT THAT AT THE
TIME VICE PRESIDENT BIDEN AND
YOU'LL HEAR FROM DR. BERTAGNOLLI
WE CAN ATTEST TO HIS COMPLIMENT
TO THE ISSUE.
THE NEW DIRECTIVE DIRECTS
FEDERAL AGENCIES TO ENSURE
FEDERALLY FUNDED PUBLICATIONS
MADE FREELY AVAILABLE AND
PUBLICLY ACCESSIBLE WITHOUT
EMBARGO.
THE SECOND COMPONENT IS MAKE
SURE SCIENTIFIC DATA UNDERLYING
PUBLICATIONS ARE ACCESSIBLE AT
THE TIME OF PUBLICATION, THIRD
REGARDLESS OF PUBLICATION STATUS
DEVELOP APPROACHES AND FINALLY
EFFORTS TO DIRECT POLICIES FOR
USE OF METADATA AND IDENTIFIERS
TO MAKE THIS INFORMATION
FINDABLE AND USABLE BY THE
COMMUNITY.
GOOD NEWS, WE'RE WELL ON OUR
WAY.
RESEARCH COMMUNITY ESPECIALLY
NIH FUNDED INVESTIGATORS MADE
PROGRESS IN FULFILLING THIS
MANDATE.
WORKING WITH YOU OVER THE COURSE
OF THE LAST SEVEN YEARS WE HAVE
OUR DATA MANAGEMENT SHARING
POLICY, IN PLACE, SATISFIES THE
FIRST PORTION.
2008 PUBLIC ACCESS POLICY
IMPLEMENTS REQUIREMENTS STATED
IN APPROPRIATIONS ACT OF 2009
REQUIRES NIH INVESTIGATORS TO
SUBMIT OR HAVE SUBMITTED
NATIONAL LIBRARY OF MEDICINE
PUBMED CENTRAL, ELECTRONIC
VERSION OF THE FINAL PEER
REVIEWED MANUSCRIPT UPON
ACCEPTANCE FOR PUBLICATION.
CURRENTLY IT IS TO BE MADE
PUBLICLY AVAILABLE NO LATER THAN
12 MONTHS AFTER THE DATE OF
PUBLICATION.
THIS HAS BEEN A SUCCESSFUL
POLICY TO DATE SINCE
IMPLEMENTATION OF THE 2008 CLOSE
TO HALF OF PUBLICATIONS ARE
ALREADY SUBMITTED TO PUBLIC MED
CENTRAL THROUGH AGREEMENTS MADE
WITH PUBLISHERS THEMSELVES.
REMAINING HALF DEPOSITED BY THE
AUTHORS.
A THIRD OF ARTICLES ALREADY
SUBMITTED HAVE NO EMBARGO PERIOD
DESPITE THE YEAR-LONG PERIOD
AVAILABLE TO THEM.
HOW DO WE GET ALL OF OUR
RESEARCH TO GO TO ZERO?
THE GOAL OF EQUITABLE ACCESS AND
ENSURING BENEFITS OUTWEIGH THE
COSTS.
THIS BRINGS US TO NIH CURRENT
POLICY PROPOSAL, RECENTLY
OUTLINED IN OUR PUBLIC ACCESS
PLAN PROVIDED TO THE WHITE
HOUSE.
I'D LIKE TO EMPHASIZE THIS IS
OUR PROPOSAL.
IF YOU'VE NOT BEEN PAYING
ATTENTION, THIS IS THE PROPOSAL
WE'RE SEEKING INPUT, NO DRAFT
POLICY HAS BEEN PUT OUT.
THE FIRST EXPECTATION ON ACCESS
TO PUBLICATION IS PEER REVIEWED
SCHOLARLY PUBLICATIONS WILL BE
MADE FREELY AVAILABLE AND
PUBLICLY ACCESSIBLE.
WE PLAN TO CONTINUE A NUMBER OF
CURRENT PRACTICES ALREADY
ACHIEVING THIS GOAL.
PUBLIC MED CENTRAL WOULD WONT TO
SERVE AS DESIGNATED REPOSITORY,
MANUSCRIPTS CAN BE SUBMITTED TO
PMC AT THE TIME OF ACCEPTANCE.
BECAUSE IT'S GOOD FOR SCIENCE,
WE'LL MAKE ARTICLES AVAILABLE
POST-PUBLICATION IN PUBMED
CENTRAL AS PROCESSING IS
COMPLETE WITHOUT EMBARGO.
THAT'S THE PROPOSAL AND
DIRECTIVE FROM THE WHITE HOUSE.
TO HELP MEET THESE EXPECTATIONS,
WE PROPOSE PROVIDING GUIDANCE,
LOOKING FOR YOU TODAY,
CLARIFYING, NECESSARY TO COMPLY
AND TECHNICAL DETAILS.
THE NEXT IS AGENCIES WILL
MAXIMIZE REACH, ALLOW MORE
MACHINE READABILITY.
CURRENTLY CONVERTS AND ALLOWS
FOR USE OF METADATA, PLAN TO
CONTINUE THESE PRACTICES.
TO FURTHER AIMS HERE UNDER THE
POLICY DIRECTIVE WE PLAN TO
CONTINUE TO WORK WITH THE
COMMUNITY TO DEVELOP AND UPDATE
STANDARDS FOR SUBMISSION.
WE'VE BEEN SEEKING PUBLIC INPUT
ON OTHER THINGS WHICH I'LL SAY
MORE ABOUT.
FINALLY THE MEMO EXPECTS
AGENCIES TO ALLOW RESEARCHERS TO
INCLUDE REASONABLE PUBLICATION
COSTS AS ALLOWABLE EXPENSES.
GOOD NEWS, CURRENTLY NIH THROUGH
GRANTS POLICY STATEMENT ALLOWS
FOR REASONABLE PUBLICATION COSTS
AND WE'LL CONTINUE THESE
PRACTICES.
PROPOSAL DOES NOT REQUIRE
RESEARCHERS TO PUBLISH IN
JOURNALS ADOPTING SPECIFIC
BUSINESS MODELS, WE DO WANT TO
ENSURE WE'RE MONITORING TRENDS
IN PUBLICATION TO ENSURE THEY
REMAIN REASONABLE AND EQUITABLE.
I MENTIONED THIS WAS REFERENCED
IN THE PUBLIC ACCESS PLAN
SUBMITTED TO THE WHITE HOUSE IN
RESPONSE TO THE MEMO BUT STILL
CONSIDERED DRAFT FORM.
WHEN WE SUBMITTED OUR PLAN WE
ALSO POSTED ONLINE ASKED FOR
COMMENT ON PROPOSALS AND HELD A
LISTENING SESSION.
I ANTICIPATE WE'LL HAVE MORE
WORKSHOPS AS WE MOVE FORWARD.
TO DATE WE'VE RECEIVED
TREMENDOUSLY INFORMATIVE
FEEDBACK FROM A BROUGHT SET OF
MEMBERS OF THE PUBLIC INCLUDING
PUBLISHERS, LIBRARIANS, RESEARCH
PARTICIPANTS, PROFESSIONAL
ORGANIZATIONS AND MORE.
IN RESPONSE TO OUR REQUEST FOR
INFORMATION, OPEN FOR TWO MONTHS
AND CLOSED IN APRIL, WE RECEIVED
143 RESPONSES WHICH I'LL
HIGHLIGHT NOW FOR YOU.
GIVEN THE GOALS OF INCREASING
EQUITY WE ENCOURAGED RECIPIENT
TO COMMENT ALSO ON HOW DIRECTLY
IMPACTS ISSUES OF EQUITY.
THIS IS IN TERMS OF PEOPLE WHO
WANT TOKING A SAYS INFORMATION
AND MAKE THAT A PROCESS AS WELL
AS THOSE SUBMITTING FOR
PUBLICATION.
I LISTED HIGHLIGHTED TOPICAL
AREAS ON THE LEFT, DEMOGRAPHICS
ON THE RIGHT.
I WON'T GO INTO DETAIL BUT I
WILL NOTE WE HEARD FROM MANY
RESEARCHERS, ESPECIALLY ACADEMIC
INSTITUTIONS, AS WELL AS
SOCIETIES FROM ACADEMIC
DISCIPLINES THAT HOUSE THEIR OWN
JOURNALS.
ALSO BEFORE I BEGIN I WOULD LIKE
TO THANK THE STAFF FOR WORKING
AT A BREAK-NECK PACE TO PROVIDE
A PRELIMINARY ANALYSIS FOR YOU
TODAY SO WE COULD DIVE INTO
DETAIL.
I DON'T THINK IT'S A SURPRISE
HERE THAT MAJORITY SUPPORTED THE
THE
REMOVAL OF EMBARGO PERIOD SAYING
IT LIMITS AVAILABILITY.
WE ALL KNOW THE DEVIL IS IN THE
DETAILS.
MANY EMPHASIZE REMOVAL IS NOT
LIKELY TO BE THE SILVER BULLET.
THIS IS BECAUSE ACCESSIBILITY
AND AVAILABILITY ARE NOT
NECESSARILY ONE AND THE SAME
THINGS.
RESPONDERS RAISE PUBLICATIONS
EVEN WHEN THEY ARE AVAILABLE CAN
BE DIFFICULT TO FIND.
TRANSLATING RESEARCH
PUBLICATIONS INTO ACCESSIBLE
FORMATS INCLUDING DIVERSE
CONSUMERS IS NOT ALWAYS OPTIMAL.
I WANT TO DIVE INTO COMMON
THREADS, WHAT WE'VE HEARD
THROUGH THE MECHANISMS, AND
WHERE NIH IS THINKING ON HOW TO
ADDRESS AND MOVE FORWARD.
FIRST ONE OF THE THINGS WE HEARD
FROM RESPONDENTS WERE CONCERNS
MOVING TO OPEN ACCESS POLICY.
RESPONDENTS MADE IT CLEAR NIH
MUST COMMUNICATE DIFFERENCE
BETWEEN PUBLIC ACCESS POLICIES
AND DIRECTIVE FOR USE OF OPEN
ACCESS PUBLICATION.
MOVING FORWARD IT'S IMPORTANT WE
ALL WORK TOGETHER TO EMPHASIZE
PUBLIC ACCESS IS A LARGE
UMBRELLA TERM THAT USUALLY
REFERS TO POLICIES THAT MAKE
PRODUCTS FREELY AVAILABLE TO THE
PUBLIC AS QUICKLY AS POSSIBLE.
THIS REFERS TO DATA AND
PUBLICATION AND METADATA TO
TRACK AND FIND THEM.
OPEN ACCESS ON THE OTHER HAND IS
A PUBLISHING MODEL FOR SCHOLARLY
COMMUNICATION THAT MAKES
RESEARCH INFORMATION AVAILABLE
TO READERS AT NO COST.
THERE ARE MANY TYPES OF OPEN
ACCESS MODELS WHICH I WON'T GET
INTO BUT IT IS SUFFICIENT TO SAY
WHEN PUBLICATIONS ARE PUBLISHED
VIA OPEN ACCESS, SOMEONE HAS TO
BEAR THE COST OF PEER REVIEW,
EDITING, TYPESETTING,
ORGANIZING, THIS DOES FALL TO
THE INVESTIGATOR IN SOME MODELS.
TO BE CLEAR, THE MEMO IS
AGNOSTIC AS TO WHAT PUBLISHING
MODELS JOURNALS CHOOSE.
NIH EMPHASIZES AND ECHOES THE
STATEMENT WE DO NOT ANTICIPATE
REQUIRING A SPECIFIC MODEL BUT
CHANGES MAY DRIVE CHANGES IN
BUSINESS MODELS NOT UNDER OUR
CONTROL.
REGARDING THE MOVE TO ZERO
EMBARGO WE HEARD REMOVAL OF
EMBARGO PERIOD MAY LEAD TO
CHANGE IN PUBLISHER BUSINESS
MODELS THAT PROMOTE EQUITY IN
ACCESS FOR READERS, INCREASE
INEQUITY FOR AUTHORS.
FINER POINT, SOME COMMENTERS
WERE CONCERNED ANY SHIFT OF
PRIORITIZING OPEN ACCESS WOULD
PLACE BURDEN OF COST ON THE
INVESTIGATOR IN TERMS OF ARTICLE
PROCESSING CHARGE IMPACTING
THOSE ARE LESS FUNDING OR PAYING
FOR VOLUME INSTEAD OF QUALITY.
MANY COMMENTERS WANTED
REASSURANCE AUTHORS COULD COMPLY
WITHOUT PAYING APCs IF THEY
DEPOSIT ACCEPTED MANUSCRIPTS IN
PUBMED CENTRAL.
WE MAINTAIN IT CAN BE MET AT NO
COST BY DEPOSITING, AND THAT'S
OUR PROPOSAL MOVING FORWARD.
COMPLIANCE CAN BE MET THROUGH
DEPOSITION IN PUBMED CENTRAL I
DON'T WANT TO GLOSS OVER THE
CONCERNS REGARDING POTENTIAL FOR
SHIFT IN COST.
THIS IS HIGHLIGHTED IN A SURVEY
ON EXPERIENCE AND PERSPECTIVES
REGARDING PUBLISHING COSTS,
WHICH INDICATE NEARLY 2/3 OF
RESEARCHERS REPORTED THEY DO NOT
BUDGET FOR PUBLISHING COSTS AND
1/3 HAD NEVER PAID AN APC.
THE RIGHT INDICATES THERE ARE
CHOICES AFFECTING CONDUCT,
PARTICIPATING IN WORKSHOPS OR
PROFESSIONAL DEVELOPMENT, OR
HIRING ADDITIONAL TRAINEES
INSTEAD SO THEY CAN PAY FOR OPEN
ACCESS.
ADDITIONAL DATA INDICATE THESE
CHOICES MAY ALSO HIT SPECIFIC
COMMUNITIES HARDER WHICH IS AN
IMPORTANT CONSIDERATION IN
ACHIEVING FIRST GOAL OF EQUITY.
WE'RE AWARE THAT PUBLISHERS ARE
PILOTING A VARIETY OF MODELS TO
MAINTAIN HIGH QUALITY PEER
REVIEWED PRACTICES BUT ALSO KEEP
COST MODELS SUPPORTIVE OF
ADVANCING EQUITY FOR AUTHORS.
THE DIRECTOR AFFECTS THE
ENTIRETY, THERE'S TREMENDOUS
STATUS TO REACH OUTCOME.
NIH IS IN DISCUSSION WITH
GOVERNMENT PARTNERS AND WITH
PUBLISHERS AS WELL TO CHART A
REASONABLE PATH FORWARD.
BEYOND PUBLISHING MODELS
RESPONDENTS HAD SUGGESTIONS TO
HELP US GET THROUGH INCLUDING
KEEPING CURRENT REQUIREMENTS AND
DEPOSITING MANUSCRIPTS WITH NO
COST.
MANY RESPONDENTS AGREE WITH NIH
PLAN TO CONTINUE MONITORING
COSTS AND SHIFTING MODELS.
SEVERAL SUGGESTED IT'S CRITICAL
TO DETERMINE WHAT IS REASONABLE
AND ASSOCIATED AS REASONABLE
COST.
THE NIH GRANT POLICY STATEMENT
ALREADY ALLOWS FOR INVESTIGATORS
TO PAY FOR REASONABLE COSTS
ASSOCIATED WITH PUBLISHING.
MANY METHODS WERE SUGGESTED
INCLUDING LOOKING AT APPLICATION
BUDGETS, ANNUAL REPORTS.
CONTINUING TO WORK WITH
PUBLISHERS TO UNDERSTAND
PUBLISHING MODELS OSH DISCIPLINE
SPECIFIC REQUIREMENTS.
AND REFERENCING CURRENTLY
EXISTING RESOURCES SUCH AS
JOURNAL COMPARISON SERVICE.
RESPONDENTS EMPHASIZE COST OF
PUBLICATION WERE DIRECTLY
RELATED, AND NIH MUST CONTINUE
TO MONITOR COSTS, NOT ONLY FOR
AGENCIES BUT IN TERMS OF
IMPLICATION FOR EQUITY.
FINALLY, A CONCERN, WE WANTED TO
ADDRESS CONCERNS ABOUT POTENTIAL
FOR INCREASED ADMINISTRATIVE
BURDENS, NOT ALL INSTITUTIONS
HAVE MONEY TO SUPPORT LOCAL
GUIDANCE, ESPECIALLY IF
INVESTIGATORS HAD TO WORK WITH
THE PUBLISHER FOR DIFFERENT
VERSIONS.
RESPONDENTS INDICATED NIH COULD
EASE BURDEN BY CLARIFYING AND
EASING MECHANISMS OF COMPLIANCE
SUCH AS ISSUING CONCISE GUIDANCE
AND TEMPLATE LANGUAGE FOR
RETAINING LICENSE.
COMMENTS RECEIVED TO DATE ARE ON
THE INITIAL POLICY PROVISION.
PLEASE REMEMBER WHAT WE'RE
TALKING ABOUT RIGHT NOW IS A
DRAFT PLAN.
WE RECOGNIZE POLICY DEVELOPMENT
IS ITERATIVE AND IMPLEMENTATION
TAKES TIME.
WE'VE WORKED WITH INTERAGENCY
PARTNERS TO HAVE SHARED GOALS
AND COMMONALITIES, AND ENSURE WE
HAVE TIME TO SOLICIT INPUT AND
DRAFT A POLICY THAT DELAYS WHEN
THE POLICY TAKES EFFECT.
WE'VE GOT 2.5 YEARS UNTIL
REVISED PUBLIC ACCESS POLICY
NEEDS TO TAKE EFFECT, BUILDING
IN MULTIPLE PLACES TO SEEK
INPUT.
DRIVING THE DISCUSSION NIH IS
WORKING ACROSS THE WHOLE OF U.S.
GOVERNMENT AND WITH COMMUNITY TO
MAKE AN OPEN DATA ECOSYSTEM A
REALITY.
WE'RE GOING TO CONTINUE TO DO
SO.
WE RECOGNIZE NEED FOR
COORDINATION AT ALL LEVELS.
I WOULD ASK GIVEN NIH IS THE
WORLD'S LARGER FUNDER OF
RESEARCH, WHAT ROLES AND
RESPONSIBILITIES DO AWARDEES
HAVE IN MAKING THIS AVAILABLE TO
THE PUBLIC IMMEDIATELY AND FREE
COST?
WHAT ARE THE FUTURE
OPPORTUNITIES AND CHALLENGES FOR
PUBLIC ACCESS REGARDING RESEARCH
PROJECTS?
AND OF COURSE WHILE WE'RE
DEVELOPING POLICIES HOW CAN WE
ACHIEVE POLICY AIMS, WHO SHOULD
BE PROVIDING INCENTIVES IN TERMS
OF WE ALL HAVE A SHARED ROLE.
WITH THAT I WILL TURN IT TO DR.
TABAK AND DR. SCHWETZ TO
MODERATE AND I'M HAPPY TO ANSWER
ANY QUESTIONS.
>> THANKS, LYRIC.
REALLY IMPORTANT QUESTIONS.
[AUDIO DISTORTION]
DOES ANYONE HAVE QUESTIONS?
PLEASE RAISE YOUR VIRTUAL HAND
SO WE CAN CALL ON YOU.
>> THERE ARE FOUR MEMBERS WHO
HAVE HANDS RAISED, TARA.
>> I CAN'T SEE THEM BECAUSE OF
THE CURRENT VIEW.
>>ROBERTA, YOU'RE NUMBER ONE.
GO AHEAD.
>> FIRST LET ME SAY IT'S BEEN
AN HONOR TO SERVE ON THE NIH
DIRECTOR'S ADVISORY COMMITTEE,
AND LOOK FORWARD TO LEARNING
MORE AS YOU GO FORWARD.
MY QUESTION REALLY IS AROUND THE
DATA FORMATTING.
MOST LABORATORIES ARE NOT DATA
SCIENCE LABORATORIES, MANY ARE
BENCH LABORATORIES, BENCH
SCIENCE LABORATORIES AND
CLINICAL SCIENCE.
SO, I'M WONDERING TO WHAT EXTENT
THE NIH IS PURSUING A UNIFORM
DATA FORMAT STRATEGY THAT WILL
EITHER BE COMMERCIALLY AVAILABLE
OR PUBLICLY AVAILABLE FOR MOVING
THIS DATA SHARING CAPACITY
FORWARD.
>> THIS IS OBVIOUSLY ONE OF THE
BIG QUESTIONS A LOT OF PEOPLE
HAVE IN TERMS OF STANDARDS TO
MAKE DATA USE AND SHAREABLE AND
LIMIT BY TRYING TO FORCE INTO A
STANDARD.
WE'RE WORKING HARD WITH
NIH-FUNDED RESEARCHES,
COLLEAGUES AT NSF AND OTHERS TO
DETERMINE WHERE PUTTING
STANDARDS IN PLACE WOULD HELP
DRIVE THE COMMUNITY FORWARD BUT
WHERE DO WE NEED TO CONVENE THE
COMMUNITY FOR SELF-ADOPTED
STANDARDS.
ONE OF THE WAYS WE HOPE TO
CATALYZE IS BY MAKING OUR DATA
MANAGEMENT AND SHARING PLAN
PUBLICLY ACCESSIBLE SO THE
RESEARCH COMMUNITY CAN LOOK AT
OTHER DATA SHARING PLANS AND SEE
BY WHAT STANDARDS ARE THEY USING
AND COLLECTING AND SHARING
INFORMATION THAT PEOPLE CAN
SELF-ASSEMBLE AROUND DATA
SHARING STANDARDS AND THEN MOVE
FORWARD WITH A COLLECTIVE VIEW.
AT THE SAME TIME THE PUBLIC
ACCESS MEMO FROM THE WHITE HOUSE
HAS ASKED US TO DEVELOP GUIDANCE
AND POLICY AROUND PERSISTENT
IDENTIFIERS, IT'S SOMETHING
WE'LL BE MOVING FORWARD, TRYING
TO HAVE THAT PUSH/PULL, ADOPTING
STANDARDS THAT MAKES SENSE AS
WELL AS ESTABLISHING BASELINE
PARAMETERS TO GET US THERE.
>> I APPRECIATE ALL THAT DEEP
THINKING.
I'M MUCH MORE ON THE PRAGMATIC
LEVEL, IS NIH WORKING WITH, FOR
EXAMPLE, DATA SCIENCE COMPANIES
TO CREATE THESE PLATFORMS THAT
THEY ARE ALMOST PLUG AND PLAY,
THOSE ARE THE KINDS OF ISSUES
THAT I THINK ARE GOING TO HAVE A
TREMENDOUS IMPACT ON THE KIND OF
RESEARCH LABORATORIES THAT ARE
INDIVIDUALLY FUNDED.
>> I WOULD TURN TO DR. TABAK OR
DR. SCHWETZ.
DR. SUSAN GREGURICK RUNS THE
OFFICE OF DATA SCIENCE STRATEGY
IS WORKING WITH PRIVATE SECTOR
AND MORE TO ESTABLISH ACTUAL
PLATFORMS FOR RESEARCHERS TO
UTILIZE.
>> THANK YOU.
THAT'S GREAT NEWS.
>> I THINK YOU JUST SAID IT,
LYRIC.
THANKS.
>> ALL RIGHT.
ALEXA?
>> THANKS.
REALLY ENDORSE THIS WORK.
SO IMPORTANT.
AGAIN, HAVE BEEN SEEING REALLY
HIGH RATES FOR THESE
PUBLICATIONS, VERY PROBLEMATIC
FOR ESPECIALLY INVESTIGATORS
DOING INITIATING SITE INITIATED
WORK WITH LIMITED FUNDING, SO WE
ENDORSE KEEPING AN EYE ON THAT.
ONE COMMENT, THERE'S A THEME
THAT WASN'T TOUCHED ON, PUTTING
THESE THINGS INTO THE OPEN
DOMAIN IS REALLY BENEFICIAL FOR
THE RESEARCHERS BECAUSE RESEARCH
IS ACCESSED MORE AND CITED MORE.
WHEN WE TALK ABOUT
ADMINISTRATIVE BURDEN THERE'S A
WAY TO ADDRESS THAT AS THE
TRADEOFF IN MAKING THIS AND
THERE'S GOOD DATA SO FAR AROUND
THAT, AND MAYBE AN OPPORTUNITY
TO COLLECT DATA AROUND HOW THIS
ACTUALLY INCREASES CITATION
RATES.
SO JUST WANT TO MAKE SURE THAT
POSITIVE ASPECT GOT PUT INTO THE
NARRATIVE AROUND THIS.
THANK YOU.
>> EXCELLENT POINT.
THANK YOU VERY MUCH.
TESHIA?
>> THANK YOU.
THANK YOU FOR THE PRESENTATION
AS WELL.
IF I COULD START WITH ALSO
SHOWING GRATITUDE TO DR. TABAK
AND THE COMMITTEE ALLOWING ME TO
BE A NEW MEMBER.
IN THAT ROLE I'M GOING TO SPEAK
TO MAYBE THE CONCEPT OF BALANCE
HERE FOR COMMUNITIES WHO ARE
OFTEN STIGMATIZED FROM RESULTS
OF RESEARCH, PARTICULARLY
HAPPENS IN THE PUBLICATION
PROCESS.
AND SO I'M CURIOUS AS TO WHAT IS
BEING DONE OR AT LEAST TO PUT A
COMMENT OUT THERE FOR
CONSIDERATION, REGARDING THE
PREVENTION OF STIGMATIZATION
BOTH IN THE DATA ACCESS PIECE,
SO THE BIOSECURITY POLICY AND
PROTECTIONS AND REVIEW PROCESSES
THAT ARE PUT FORWARD TO PROTECT
THOSE COMMUNITIES.
I THINK THERE'S BOTH SOME
CHALLENGES AND SOME
OPPORTUNITIES HERE.
THANK YOU.
>> LET ME JUMP IN, AND THEN
LYRIC AND TARA CAN ADD ANYTHING
THAT I MAY HAVE OMITTED.
THE ISSUES THAT I BRING UP OF
COURSE ARE VERY REAL AND
CRITICALLY IMPORTANT.
BUT THE INTERVENTIONS ARE NEEDED
WELL BEFORE THE PUBLICATION, YOU
KNOW, APPEARING.
AND, YOU KNOW, I DID MENTION IN
MY OPENING REMARKS THAT WE HAVE
RECENTLY SUCCESSFULLY RECRUITED
A NEW DIRECTOR OF TRIBAL HEAD
OFFICE, AND THAT OFFICE REALLY
GUIDES ALL THE INSTITUTES AND
CENTERS IN THE APPROPRIATE WAY
THAT, FOR EXAMPLE, ONE NEEDS TO
ENGAGE WITH TRIBAL LEADERSHIP
AND TRIBAL NATIONS, INCLUDING
FORMAL CONSULTATIONS AS WELL AS
INFORMAL DISCUSSIONS, AND OVER
THE PAST MANY YEARS OUR AGENCY
HAS BEEN INVOLVED IN NUMEROUS
FORMAL CONSULTATIONS AS WELL AS
INFORMAL DISCUSSIONS ABOUT THESE
ISSUES.
AND OF COURSE THE CONCERNS YOU
RAISE ARE NOT LIMITED TO TRIBAL
NATIONS YOU ABOUT INDEED MANY
COMMUNITIES THAT HAVE BEEN
MARGINALIZED, DISADVANTAGED, SO
FORTH, THERE MAY BE A LESS
FORMAL WAY OF WORKING THROUGH
THESE, SO WE'RE VERY SENSITIVE
TO THIS.
WE TRY AND WORK DIRECTLY WITH
THE POTENTIALLY AFFECTED
COMMUNITIES, FOR EXAMPLE, WITH
OUR "ALL OF US" PROGRAM, THERE'S
BEEN TREMENDOUS AMOUNT OF CARE
TAKEN TO NAVIGATE THIS SO WE
DON'T WIND UP WITH THIS JUST
TERRIBLE OUTCOME, YOU KNOW, WHEN
IT HAPPENS.
ADDITIONALLY, I'M GOING TO TURN
TO MIKE LAUER, IF HE'S STILL ON,
IN INSTANCES WHERE WE DO SEE
SORT OF EGREGIOUS BEHAVIOR, IF
YOU WILL, A MISUSE OF DATA, FOR
EXAMPLE, FOR UNTOWARD REASONS,
WE DO TAKE SOME ACTION.
MIKE, MAYBE YOU WOULDN'T MIND
PLEASE ADDRESSING THAT POINT.
>> THESE RO REFERRED TO AS DATA
MANAGEMENT INCIDENTS, SO WE'VE
HAD CASES WHERE PEOPLE HAVE
VIOLATED DATA USE AGREEMENT.
MOST SIGNED BY SCIENTISTS BUT
ALSO THEIR INSTITUTION.
AND SO ONE LEVERAGE THAT WE HAVE
HAD INSTITUTIONAL OFFICIALS
THEMSELVES.
WE'VE HAD CASES WHERE WE'VE GONE
TO INSTITUTIONAL OFFICIALS,
IDENTIFIED VIOLATIONS OF DATA
USE AGREEMENTS, INAPPROPRIATE
USE OF DATA AND VARIOUS ACTIONS
HAVE BEEN TAKEN.
AND AS AN EXAMPLE OF ONE ACTION,
IS THAT WE SUSPEND THE ABILITY
OF PARTICULAR SCIENTIST TO HAVE
ACCESS TO DATA FOR A PERIOD OF
TIME.
WE'VE DONE THAT.
THERE HAVE BEEN CASES IN THE
COURSE OF ACTIONS THEY HAVE
VIOLATED INSTITUTIONAL POLICIES
AND INSTITUTIONAL LEADERS CAN
HOLD SCIENTISTS APPROPRIATELY
ACCOUNTABLE, AS DEPENDING ON THE
SPECIFIC CIRCUMSTANCES.
>> THANKS, MIKE.
LYRIC OR TARA, HAVE I LEFT
ANYTHING OUT?
>> YOU EXPRESS OUR COMMITMENT
VERY PERFECTLY.
WE'RE THINKING ABOUT IT FROM
BEGINNING THROUGH AND THAT
PIPELINE I SHOWED ABOUT SHARING
INFORMATION FROM THE DATA
MANAGEMENT SHARING POLICY THAT
SAYS THERE ARE LIMITS TO SHARING
IF THERE ARE ETHICAL OR SOCIAL
IMPLICATION TO ACCESS REQUEST,
PART IS LOOKING DOES IT HAVE
POTENTIAL FOR STIGMATIZING
RESULTS INTO THE PLACE OF HOW
AND WHAT INFORMATION PEOPLE WANT
THROUGH ANOTHER ENGAGEMENT WITH
AN ADVISORY COMMITTEE DIRECTOR
ASKING REAL PEOPLE ACROSS THE
COUNTRY WHAT ARE IMPLICATIONS
FOR YOU, YOUR FAMILIES, AND THE
COMMUNITIES THAT YOU LIVE IN.
WE'RE TAKING A REAL HOLISTIC
APPROACH TO THE QUESTION, I
APPRECIATE YOU RAISING IT.
>> YEAH, AND, AGAIN, I'D LIKE
TO ADD MY THANKS.
WE LOOK FORWARD TO CONTINUED
GUIDANCE AS WE GO FORWARD.
THIS IS A TOPIC THAT YOU HAVE
SPENT A LOT OF TIME WORKING IN
AND THINKING ABOUT.
SO THANK YOU.
>> I JUST WANT TO BE CLEAR WHAT
I'M SUGGESTING IS EVERYTHING
YOU'RE DOING IS GREAT.
I DON'T HAVE A PROBLEM WITH
THAT.
I'M STEPPING INTO A SPACE WHERE
I CAN CLEARLY SAY THAT I'M A
DINOSAUR WHERE TECHNOLOGY IS
CONSIDERED, SO I HAPPILY 'EM
--
EMBRACE THAT.
AS YOU TALKED ABOUT PREPAREDNESS
AROUND COVID THAT WE ARE
THINKING ABOUT THE NEXT PANDEMIC
AND THAT MADE ME THINK ABOUT THE
DATA AND THE WAY THAT TECHNOLOGY
AND THOSE PEOPLE WHO WOULD DO
HARM ARE, YOU KNOW, ALWAYS AHEAD
OF US, ALWAYS AHEAD OF US HOW TO
TAKE ADVANTAGE OF THOSE
SITUATIONS.
SO I THINK THERE MIGHT BE AN
OPPORTUNITY, I DON'T KNOW, BUT
IN THAT VEIN FOR NIH TO BE
INVOLVED.
TO BE INVOLVED IN HOW CAN WE
ENGAGE TECHNOLOGY COMMUNITY IN
RESEARCH ABOUT SPECIFICALLY THE
PROTECTION OF BIODATA AND AS WE
BEGIN TO BE MORE OPEN WITH THE
DATA THROUGH "ALL OF US" AND
OTHER TYPES OF PROGRAM HOW DO WE
STAY ONE STEP AHEAD, SO I THINK
THERE'S SOME OPPORTUNITY THERE
AND THAT'S MY POINT, TO OFFER
THAT CHALLENGE AND MAYBE TO
GET -- YEAH.
>> THANK YOU.
THAT'S A GOOD SEGUE.
OUR NEXT QUESTIONER IS AN EXPERT
IN THE TECHNOLOGY.
I DON'T KNOW IF YOU'RE GOING TO
SPEAK TO THAT DIRECTLY BUT
YOU'RE UP NEXT.
>> NOT DIRECTLY.
THANKS FOR THE GREAT UPDATE.
TODAY WE'RE TALKING ABOUT MORE
ABOUT OPEN ACCESS PUBLICATIONS,
INSTEAD OF OPEN ACCESSION DATA,
WHICH COULD BE ITS OWN
SEVERAL-HOUR DISCUSSION.
I HAVE A BUNCH OF QUESTIONS.
I'LL START WITH THE MOST
CONTROVERSIAL ONE FIRST.
WHY IS NIH JUST CONSIDERING
REASONABLE PUBLICATION COSTS,
WHY NOT DIRECTLY LOWER THEM?
FOR EXAMPLE WE NOW HAVE CMS
NEGOTIATING DRUG PRICING, RIGHT?
WHY COULDN'T NIH ENTER
DISCUSSIONS TO DIRECTLY LOWER
ARTICLE OF PUBLISHING INDICATION
COSTS FOR NIH-FUNDED
INVESTIGATORS?
WE'VE TAKEN SOME STEPS AT THE
UNIVERSITY OF CALIFORNIA LIKE
WITH ELSEVIER, I'M NOT SAYING
IT'S EASY OR WITHOUT CONTROVERSY
BUT WHY COULDN'T NIH JUST START
TO ASK THEM TO BE LOWERED?
LET ME START WITH THE FIRST
QUESTION.
>> LET ME JUMP IN BECAUSE MY
TEAM IS POINTING THE FINGERS AT
ME HERE TO ANSWER THAT.
INDEED WE'VE THOUGHT ABOUT THIS.
AS YOU MIGHT IMAGINE, SHOULD WE
EMBARK ON THAT APPROACH, WE
ENTER A VERY COMPLEX ECOSYSTEM.
BUT I THINK, YOU KNOW, ONE WE'RE
NOT GOING TO NECESSARILY SHY
AWAY FROM BUT WANT TO ENSURE
THAT WE HAVE THOUGHT THROUGH ALL
OF THE POTENTIAL IMPLICATIONS,
SO I THINK YOUR POINT IS A VERY
GOOD ONE.
AND SO I WOULD JUST SAY STAY
TUNED TO SEE WHETHER OR NOT THE
VARIOUS DISCUSSION ULTIMATELY
LEAD US IN THAT DIRECTION, OR
NOT.
SO TO BE CONTINUED.
OKAY?
>> I APPRECIATE THAT.
THREE SORTER AND SIMPLER
QUESTIONS NEXT.
ONE STEP TOWARDS GETTING THERE
MIGHT BE TO ACTUALLY TRACK HOW
MUCH NIH SPENDS ON THESE THINGS.
DO WE HAVE ANY IDEA YET WHAT
PERCENT IS SPENT ON ARTICLE
PUBLICATION COST, IS THERE ANY
WAY TO TRACK THAT YET?
>> I DON'T THINK IT'S
INCREDIBLY LARGE.
MIKE, WOULD YOU HAVE ANY INSIGHT
VIS-A-VIS EXTRAMURAL RESEARCH?
>> SO AT ONE POINT WE DID MAKE
AN ESTIMATE, AND IT'S A VERY
SMALL PERCENTAGE OF THE OVERALL
COST.
>> AND NINA, FOR THE INTRAMURAL
PROGRAM WOULD YOU CONCUR?
>> YEAH, I THINK IT'S MORE OF A
PROBLEM FOR THE INDIVIDUAL
INTRAMURAL PROGRAM SCIENTIST BUT
I DON'T THINK OVERALL BECAUSE
THE NUMBERS ARE SO MUCH SMALLER
THAN IT IS IN EXTRAMURAL.
I DON'T THINK OVERALL IT WOULD
BE A SIGNIFICANT INCREMENT.
>> THANK YOU BOTH.
>> WE CAN TRACK THAT TO MAKE
SURE IT DOESN'T CONTINUE TO
RISE.
>> WE PROPOSED TRACKING TO
MONITOR AND ASSESS COSTS TO US,
AUTHORS, MODELS, THAT'S
SOMETHING WE PROPOSED.
>> GREAT.
TWO MORE QUICK QUESTIONS ON
PUBMED CENTRAL ITSELF.
DO WE HAVE USAGE DATA ON PUBMED
CENTRAL?
I WAS GOOGLING AND COULDN'T FIND
ANYTHING FROM NLM.
DO WE SEE THE PUBLIC USING IT?
WE DON'T ADVERTISE TO THE PUBLIC
AND SHOULD WE?
>> WE CERTAINLY TRACK THIS
INFORMATION.
I CAN'T SPEAK ON BEHALF OF DR.
BRENNAN, IT'S VERY WIDELY USE,
AND WE'RE HAPPY TO FOLLOW UP
WITH THAT INFORMATION AND IT
CHANGES OBVIOUSLY DAILY.
THAT'S WHY MY STATISTICS ARE
ALREADY OUT OF DATE, WENT FROM
150,000 TO 500,000 PAPERS IN THE
COURSE OF A YEAR.
>> THAT'S GREAT.
WOULD BE GREAT TO SEE THE PUBLIC
USING AND BENEFITING FROM IT,
MAYBE CASE EXAMPLES, HOW
PATIENTS HAVE HELPED THEMSELVES
WOULD BE GREAT TO TRACK.
LAST COMMENT, IS NIH OKAY WITH
ANY AND ALL USES FOR PUBMED
CENTRAL?
I MEAN, I'M SITTING IN SILICON
VALLEY, HOWARD AND OTHERS
SURROUNDED BY COMPANIES BUILDING
LARGE LANGUAGE MODELS, A.I., WE
CAN LARGE MODELS SPECIFICALLY
TRAINED ON NIH-FUNDED RESEARCH
AND THEIR PUBLICATIONS.
IT'S A NEW DIRECTION, IS NIH
GOING TO BE OKAY?
WE'RE IMAGINING USE ARE FOR
PUBMED CENTRAL THAT WEREN'T
THINKABLE FIVE YEARS AGO, IS NIH
GOING TO BE OKAY WITH THIS?
>> I'LL JUMP IN.
OF COURSE WE'RE GOING TO BE OKAY
WITH IT.
THIS IS ALL REALLY EXCITING
STUFF, RIGHT?
AND OF COURSE OUR COLLEAGUES AT
NLM, YOU KNOW, THEY HAVE BEEN
KNOWN TO WRITE A COUPLE LINES OF
CODE THEMSELVES EVERY ONCE IN A
WHILE.
I'M BEING SILLY HERE BUT
CERTAINLY PEOPLE ARE
CONTEMPLATING NOT ONLY THE
PRESENT BUT WHAT THE FUTURE IS.
AND I DO THINK WITH THAT FUTURE
COMES TREMENDOUS OPPORTUNITY
BUT, YOU KNOW I'M GOING TO SAY
NEXT, ALSO THE CAUTIONARY TALE,
RIGHT?
AND SO IT BEHOOVES US AS WE
THINK THROUGH THIS TO REALLY
UNDERSTAND ALL THE DIMENSIONS
HERE.
YES, WE CAN DO THINGS FASTER,
BETTER, GAIN INSIGHTS THAT
HERETOFORE WERE HIDDEN, THAT ONE
WOULD HAVE NEVER EVEN
CONTEMPLATED.
BUT IF YOU TURN THAT AROUND,
RIGHT, AND I KNOW YOU THINK
DEEPLY ABOUT THIS, SO LET ME --
IF YOU TURN THAT AROUND, YOU
KNOW, GOUT TO MAKE SURE YOU DO
THIS IN A WAY THAT DOES NOT
ADVERSELY AFFECT INDIVIDUALS,
COMMUNITIES, ET CETERA.
THAT GETS BACK, YOU KNOW, TO DR.
SOLOMON'S ORIGINAL COMMENTS.
AND SO BUT WE'RE NOT GOING TO BE
OSTRICHES, RIGHT?
WE REALLY HAVE TO EMBRACE THIS.
AND, YOU KNOW, OUR -- ONE OF THE
LESSONS LEARNED DURING THE
PANDEMIC WAS THE INCREDIBLE
VALUE THAT NIH GAINED FROM
WORKING WITH INDUSTRY.
WE LEARNED A LOT.
HEY, YOU KNOW, THIS ACTUALLY
COULD WORK.
MY HOPE IS THAT WE EMBRACE THAT
IN OTHER DIRECTIONS AS WELL.
THIS IS A PERFECT EXAMPLE OF
WHERE THAT NOT ONLY COULD BUT I
THINK SHOULD HAPPEN IN THE
FUTURE.
>> GREAT.
THANKS.
THANKS FOR ANSWERING ALL THESE
QUESTIONS.
>> COREY?
>> THANK YOU.
>> YOUR SOUND IS A LITTLE
MUTED.
I'M SORRY.
>> REALLY MUFFLED.
>> OKAY.
CAN YOU HEAR ME NOW?
>> THAT'S BETTER.
THANK YOU.
>> IT'S BETTER?
OKAY.
I TOO AM A NEW MEMBER TO THE ACD
AND WANT TO THANK DR. TABAK AND
NIH FOR THIS OPPORTUNITY.
I HAVE TWO QUESTIONS, PERHAPS
COMMENTS.
NUMBER ONE IN TERMS OF THE
ADMINISTRATIVE BURDEN THAT'S
BEEN DISCUSSED IN TERMS OF DATA
SHARING, CMS, HAS NIH GIVEN ANY
THOUGHT OR PLANS TO BUILDING
DATA CENTER CAPACITY AT
HISTORICALLY BLACK COLLEGES AND
UNIVERSITIES THAT MAY BE FUNDED
UNDER NIH IN DISPARITY RESEARCH
AS WELL AS TRIBAL COLLEGES AND
UNIVERSITIES AND OTHER
MINORITY-SERVING INSTITUTIONS
THAT MAY NOT HAVE THE RESOURCES
THAT OTHER INSTITUTIONS MIGHT
HAVE, HAVE YOU IDENTIFIED ANY
PARTICULAR NEED FOR DATA SHARING
CAPACITY BUILDING TRAINING OR
ANY CERTAIN RESOURCE
IDENTIFICATION TO ENSURE THEY
ARE -- [ LOW AUDIO ].
>> THIS HAS BEEN A
PROGRAM-BY-PROGRAM BASIS, AND I
WOULD THINK GOING FORWARD WE
WOULD PROBABLY WANT TO TRY A
MORE GENERALIZED APPROACH ACROSS
THE BOARD.
MIKE, I DON'T KNOW IF YOU HAVE
COMMENTS YOU'D LIKE TO MAKE
ABOUT THIS.
>> WELL, THERE ARE SOME
PROGRAMS I CAN THINK OF, I'M NOT
SURE THOSE ARE SALIENT HERE BUT
ONE IS THE AIM AHEAD PROGRAM.
THERE'S ALSO EFFORTS TO ENHANCE
RESEARCH CAPACITY AT
MINORITY-SERVING INSTITUTIONS
USING CONTRACT MECHANISMS THAT
MAY APPLY HERE.
ANOTHER IMPORTANT POINT, THE WAY
THE POLICY IS WRITTEN AND BEING
IMPLEMENTED IS THAT COSTS FOR
DATA MANAGEMENT AND DATA SHARING
ARE INCORPORATED INTO BUDGETS.
AND IN FACT WE INSIST ON THAT.
WE WANT INSTITUTIONS TO THINK
ABOUT THAT RIGHT UP FRONT.
SO, THOSE ARE THREE THINGS I CAN
THINK OF.
>> YEAH, TO BUILD OFF YOUR LAST
POINT, MIKE, WHAT WE WILL NEED
TO DO IS TO ENCOURAGE
ORGANIZATIONS, PARTICULARLY
THOSE THAT MIGHT BE SOMEWHAT
LESS FAMILIAR WITH NIH, TO
CONTEMPLATE WHAT THOSE COSTS
MIGHT BE, THAT IS THE WHOLE
COST, SO THAT THEY APPROPRIATELY
BUILD THAT IN TO ANY PROPOSAL
THAT THEY PROVIDE.
OF COURSE THE ACD REPRESENTS ONE
GOOD FORUM TO GET THAT WORD OUT.
I KNOW YOU HAD A SECOND
QUESTION.
>> YES.
(INDISCERNIBLE) IF THE ULTIMATE
GOAL IS TO TRANSLATE RESULTS TO
THE LEVEL WHICH PEOPLE CAN USE
THEM TO BENEFIT PEOPLE IN THE
COMMUNITY, PROVIDERS, OTHER
BIOMEDICAL RESEARCHERS, AND THE
LIKE, ULTIMATELY GET FINDINGS
AND RESULTS THAT IMPACT CHANGE
AT THE COMMUNITY AND INDIVIDUAL
LEVEL IN TERMS OF SHARING THIS
DATA WHAT SORTS OF MONITORING,
EVALUATION, LEARNING AGENDAS
MIGHT NIH HAVE TO GATHER DATA OR
TO GET A SENSE OF HOW THIS
INFORMATION IS BEING USED AT THE
REALLY MICRO LEVEL AND DEFINITE
WITH UNDERSERVED COMMUNITIES,
THOSE COMMUNITIES MARGINALIZED
BASED ON RACE AND POVERTY AND
RURAL AREAS OF THE COUNTRY,
WHERE INDIVIDUALS WHO HAVE
EXPERIENCED HEALTH DISPARITIES
DISPROPORTIONATELY MIGHT NOT
HAVE ACCESS TO THIS INFORMATION,
INDIVIDUALS LIVING IN THESE
AREAS.
SO, I GUESS MY BASIC QUESTION
FOLLOWS UP ON THE INITIAL
STATEMENT REGARDING THE END USER
PIECE, ULTIMATE GOAL TO GET THE
INFORMATION DOWN TO THE LEVEL
WHERE INDIVIDUALS CAN ACTUALLY
USE THIS INFORMATION THROUGH
PUBLISHING IT AND MAKING THE
INFORMATION ACCESSIBLE THROUGH
PEER-REVIEWED PUBLICATIONS.
>> THANK YOU FOR THAT.
TARA, WOULD SOME OF THE EFFORTS
IN THE RADX-UP EFFORT BE GERMANE
AS AN EXAMPLE OF THINGS BEING
ASKED ABOUT?
>> I THINK MORE APPROPRIATE S
THE CEAL EFFORT, REALLY DIRECTED
AT TRYING TO NOT JUST WORK WITH
COMMUNITIES BUT ALSO REAL FOCUS
OF THE EFFORTS IS COMMUNICATING
THAT INFORMATION TO COMMUNITIES
SO THERE HAS BEEN A LINKAGE
BETWEEN THE RADx UNDERSERVEED
POPULATION COMMUNITY, A PROGRAM
WHICH IS ABOUT, YOU KNOW, IT'S
COVID RESEARCH BUT TRYING TO
BETTER UNDERSTAND APPROPRIATE
WAYS TO DISTRIBUTE AND MAKE
ACCESSIBLE AND MONITOR UPTAKE OF
COVID TESTING OPTIONS BUT THEN
WORKING WITH THE CEAL COMMUNITY,
PROGRAM, THEY HAVE DEVELOPED OR
ARE STARTING TO BETTER
UNDERSTAND AND DEVELOP
MECHANISMS WITH WHICH TO BETTER
COMMUNICATE THAT INFORMATION TO
VARIOUS DIFFERENT COMMUNITIES.
>> THANK YOU.
DO YOU HAVE ANYTHING TO ADD ON
THIS TOPIC?
I'M NOT HEARING YOU.
>> WE'RE EVALUATING THIS.
THIS IS THE CONVERSATION WE'RE
HAVING AS A TRADEOFF BETWEEN
BURDEN, THE BURDEN CAN BE THE
GOLD STANDARD WE'RE TALKING
ABOUT MAKING SURE WE HAVE THE
HIGHEST QUALITY THAT PLACE
BURDEN ON THE SCIENTIST AND
INNOVATION BUT MAKE MAXIMAL
UTILITY OF THE DATA.
WE'RE LOOKING AT THE STEP-WISE
PROSE LET'S GET INTO THE
PRACTICE OF SHARING MAKE IT
EASY, PROVIDE REPOSITORIES AND
RESOURCES SO EVERYONE CAN ENTER
INTO THE GAME.
WE'LL KEEP MOVING THAT DOWN THE
PIPE SO WE CAN GET TO THE GOLD
STAR, MAKE IT SO EVERYONE CAN
PLAY THE GAME, AND MAKING
DISCOVERIES USEFUL FOR ALL OF
THE COMMUNITIES OUT THERE.
SO WE'RE GOING TO CONTINUE
WORKING TOWARDS THAT GOAL AND
MONITOR AND EVALUATE OUR ACTUAL
END USERS, PEOPLE UPTAKING
INFORMATION, ARE THEY SHARING
DATA, REUSING INFORMATION.
MORE TO COME IN COMING YEARS ON
THIS TOPIC.
>> THANK YOU, LYRIC.
MIKE, PLEASE, IF YOU WANTED TO
ADD ANYTHING.
>> THERE HAVE BEEN SOME
MICROANALYSES OF DATA USE.
THERE WAS A STUDY PUBLISHED BY
SOME OF OUR COLLEAGUES ON THE
USE OF DATA FROM DBGaP,
GENOMICS DATABASE SHOWING HIGH
RATE OF USAGE AND HIGH QUALITY
PUBLICATIONS.
ANOTHER WAS STUDY PUBLISHED IN
THE NEW ENGLAND JOURNAL OF
MEDICINE ON USE OF CLINICAL
TRIAL DATA FROM NHLBI STUDIES,
MOST OF THE CLINICAL TRIALS IN
WHICH DATA WERE MADE AVAILABLE
THOSE DATA WERE DOWNLOADED, A
LARGE NUMBER RESULTED IN
PUBLICATIONS.
I THINK ONE PARTICULAR EQUITY
ISSUE HERE IS THAT THESE KINDS
OF HIGH QUALITY DATA CAN BE USED
BY EARLY CAREER INVESTIGATORS.
AS THEY ARE TRYING TO GET THEIR
CAREER STARTED AND START
DEVELOPING THEIR OWN DATA, THEY
HAVE THE OPPORTUNITY TO SEE HIGH
QUALITY DATA BUT ALSO USE IT FOR
THEIR OWN SCHOLARLY OUTPUT.
>> WE ONLY HAVE A FEW MINUTES,
TO GET TO THE REMAINING HANDS.
BRIAN, YOU'RE NEXT.
>> WELL, I WANT TO THANK YOU
FOR INVITING ME TO PARTICIPATE
IN THIS ADVISORY COMMITTEE, AS A
NEW PARTICIPANTS.
I WANTED TO COMMENT ON OPEN
ACCESS PART OF THE DISCUSSION
TODAY WHICH I THINK SOUNDS LIKE
THE PROCESS WILL STAY THE SAME
BUT PERHAPS THINGS WILL NEED TO
MOVE FASTER IN TERMS OF ARTICLES
GETTING OUT AND BEING OPEN
ACCESS.
I THINK WE TALKED ABOUT THE COST
AS PURELY FINANCIAL MEASURED IN
DOLLARS PAID FOR ARTICLE
PROCESSING FEES BUT THERE'S THE
OPPORTUNITY COSTS FOR
INVESTIGATORS, MANAGING THE
PROCESS OF GETTING THE ARTICLES
INTO PUBMED CENTRAL AND THINGS
DONE TO STREAMLINE.
IT'S A FAIR BIT OF WORK UNDER
THE CURRENT SYSTEM, PARTICULARLY
IN LABS WHERE THERE MIGHT BE
PUBLICATION ACTIVITIES.
I LIKE TO TEACH MY MENTEES WHO
MIGHT BE PUBLISHING PAPERS FROM
MY GRANTS HOW TO GO THROUGH THE
PROCESS, MAKE THE DEPOSITS
THEMSELVES SO THEY COULD DO IT
AND FOLLOW THE PROCESS IN THE
FUTURE WHEN THEY ARE FUNDED BUT
THAT REQUIRES ME FREQUENTLY TO
LOG IN TO NIH MANUSCRIPT
CENTRAL, CHECK THE PROCESS, LOOK
FOR SNAGS, MENTOR THROUGH THE
PROCESS, IF THEY MISS AN E-MAIL
I'M ON THE HOOK IN TERMS OF
COMPLIANCE SO I WANT TO DO THE
RIGHT THING AND BE COMPLIANT BUT
IT'S A LOT OF ADMINISTRATIVE
BURDEN.
NLM DOES HIGH QUALITY WORK AND
UNDERTOOK USER CENTER DESIGNED
APPROACH BUT I'M WONDERING IF
IT'S WORTH LOOKING AT THAT AGAIN
AND I HAVE ONE CONCRETE
SUGGESTION.
I KNOW IN PUBMED CENTRAL MY NCBI
I CAN DELEGATE ACCESS FOR
SOMEONE TO LOOK FOR
NON-COMPLIANCE ISSUES.
I DON'T BELIEVE I CAN DELEGATE
ACCESS IN THE SYSTEM WHERE YOU
DEPOSIT AND TRACK THE DEPOSIT.
WHICH MEANS I'M THE ONLY PERSON
WHO CAN MONITOR THINGS MOVING
THROUGH THAT SYSTEM.
IF I COULD DELEGATE TO A STAFF
MEMBER WITH MY OVERSIGHT I THINK
IT WOULD REALLY REDUCE
ADMINISTRATIVE BURDEN FOR THE
P.I. SO I WOULD ENCOURAGE YOU TO
LOOK INTO THAT AND SEE IF THAT'S
AN OPTION.
MAYBE AN FAQ EXPLAINING HOW TO
DO IT MY HELP IF IT IS ALREADY
AN OPTION.
>> WE'D BE HAPPY TO LOOK INTO
THAT.
>> GREAT.
SHELLEY?
>> I HAVE A COUPLE COMMENTS
FOLLOWING UP ON THE COMMENT ON
TALKING TO SOME JOURNALS THAT
MAYBE NIH CAN MAIN INROADS.
IT'S PARTICULARLY DISTURBING THE
CELL SCIENCE NATURE JOURNALS,
THEY PUSH YOU OFF TO THEIR
PUBLIC ACCESS, CELL REPORTS,
NATURE COMMUNICATION, SCIENCE
ANSWERS, THEY ARE TWO TO THREE
TIMES THE PUBLICATION COSTS, I
THINK IT'S ACTUALLY SCANDALOUS
IT'S SO HIGH.
I DON'T UNDERSTAND IT AND I'M
WONDERING IF SOME DISCUSSION
COULD BE MADE THERE, IF YOU HAVE
COMMENT WHETHER YOU THOUGHT
ABOUT THAT, THAT ISSUE.
PARTICULARLY IT BURDENS
EARLY-STAGE INVESTIGATORS WHO
TEND TO GET, YOU KNOW, SHUFFLED
OFF INTO THOSE SO-CALLED SISTER
JOURNALS.
>> YEAH.
WELL, AGAIN, AS WE'RE THINKING
ABOUT THIS HOLISTICALLY WE'RE
PAINFULLY AWARE OF THE SPECIFIC
EXAMPLE YOU JUST PROVIDED.
THOSE KINDS OF THINGS GOING INTO
OUR THINKING GOING FORWARD.
>> AND THE OTHER THING I
WONDERED ABOUT IS bioRxiv
ALTERNATIVE.
WE HAVEN'T TALKED ABOUT IT.
IT DOESN'T COST ANYTHING.
IT'S ACTUALLY PRETTY GOOD.
I WAS RESISTING FOR A LONG TIME,
AND MY GROUP IS NOW USING THAT.
IT'S EFFECTIVE FOR MANY REASONS.
I WONDERED, YOU KNOW, LYRIC,
HAVE YOU -- HAS THAT COME INTO
PLAY IN YOUR THINKING?
>> ABSOLUTELY.
THIS IS A CONVERSATION ACD MIGHT
WANT TO HAVE AT SOME POINT.
WE'RE TALKING ABOUT PUBLIC
ACCESS, YOU NOTICE POLICY
APPLIES TO PEER REVIEWED
SCHOLARLY MANUSCRIPTS, DOESN'T
TAKE ABOUT PRE-PRINT AND WHERE
ARE THEY FOLLOWING IN THE MODEL,
IT'S A TOPIC WE'RE ACTIVELY
MONITORING AND I WOULD TURN TO
MIKE WHO IS PAYING ATTENTION
CLOSELY.
>> A NUMBER OF YEARS AGO WE PUT
OUT A STATEMENT, GUIDE NOTICE,
WE MADE IT CLEAR THAT PRE-PRINTS
ARE VIABLE AND ACCEPTABLE
RESEARCH PRODUCTS.
SO ON YOUR PROGRESS REPORTS OR
BIOSKETCH, IF YOU WANT TO REPORT
RESEARCH PROJECTS PRE-PRINTS ARE
PERFECTLY OKAY.
AND SO WE'RE SEEING A VERY LARGE
UPTAKE IN USE OF PRE-PRINTS,
IT'S HELPFUL THERE ARE SOME
JOURNALS THAT EVEN REQUIRE, COME
CLOSE TO REQUIRING THEY DON'T
ALLOW YOU TO USE PRE-PRINTS BUT
REQUIRE YOU TO USE PRE-PRINTS
AND EVEN SOME OF THE CLINICAL
JOURNALS LIKE NEW ENGLAND
JOURNAL OF MEDICINE NOW ALLOW --
AND JAMA ALLOW PRE-PRINTS, GOOD
TRENDS TO SEE.
>> ONE QUICK FOLLOW-UP ON THAT,
MIKE, THAT I NOTICE THAT I'VE
SUBMITTED A COUPLE GRANTS IN THE
LAST FEW MONTHS AND YOU CAN
LIST bioRxiv SUBMISSIONS
WHEN YOU FIRST SUBMIT A GRANT
BUT IN THAT ONE MONTH WINDOW
BEFORE IT'S REVIEWED YOU CAN'T
UPDATE WITH bioRxivS, THAT'S
SOMETHING THAT NIH COULD DO ON
ITS OWN TO MAKE THAT MORE -- A
WAY TO IMPROVE USAGE OF THAT.
>> THANK YOU.
>> FOR REFERENCE I PUT IN
PRE-PRINT PILOT WORKING THROUGH
INFORMATION, PUT IT IN THE CHAT
TO CHECK IT OUT.
>> GREAT.
HOWARD WE'LL GIVE YOU THE FINAL
WORD.
>> YES, SHELLEY ASKED MY
QUESTION SO I'M ALSO FULLY
SUPPORTIVE, IT'S IMPORTANT TO
HAVE THE PUBLIC ACCESS FOR
RESEARCH PRODUCTS AND PRE-PRINTS
ARE INCREASING IMPORTANT
COMPONENT OF ECOSYSTEM BECAUSE
THEY ALLOW TIMELY RELEASE OF
INFORMATION, AS MIKE POINTED OUT
WE CAN USE THAT INFORMATION FOR
NIH APPLICATIONS, RESEARCH
PRODUCT, AND I SEE TRAINEES
BEFORE THE APPLICATION PEOPLE
WANT TO GET DATA ORGANIZE AND
PUT IT IN PRE-PRINT SO PEOPLE
CAN SEE FULLY THE BODY OF WORK
DISCUSSED.
AND YOU CAN FORMAT OUR
INFORMATION ONCE AND MAYBE TO
PUBMED CENTRAL REDUCING
ADMINISTRATIVE BURDEN.
>> THAT'S GREAT.
THANKS, HOWARD.
ONE THING TO POINT OUT FOR THOSE
WATCHING ON THE VIDEOCAST, YOU
CAN'T SEE THE INFORMATION BEING
POSTED TO THE CHAT SO WE'LL MAKE
SURE THAT'S POSTED PUBLICLY
EITHER ON THE VIDEOCAST WEBSITE
OR ACD SITE ITSELF.
FLAGGING THAT FOR AWARENESS.
OKAY.
WE'RE ONLY NOW A MINUTE BEHIND.
WE'VE BEEN ABLE TO CATCH UP.
THANKS FOR HELPING TO MAKE THAT
POSSIBLE.
I WILL TURN IT OVER TO DR.
MONICA BERTAGNOLLI, WHO IS GOING
TO GIVE AN UPDATE ON ALL THE
WORK BEING DONE ON CANCER
MOONSHOT.
MONICA?
>> THANK YOU.
IT'S SUCH AN HONOR TO BE HERE,
TO PRESENT TO YOU ALL AND GET
YOUR FEEDBACK.
I'M REALLY THRILLED AND EXCITED
TO BE ABLE TO PRESENT FOR NCI.
TODAY.
IT'S ALSO A PLEASURE TO TELL YOU
ABOUT THIS VERY SPECIAL PROJECT
THAT STARTED EIGHT YEARS AGOE
THAT NOW IS GUIDING NCI RESEARCH
OVERALL, CANCER MOONSHOT.
NEXT SLIDE PLEASE.
CANCER MOONSHOT BEGAN IN 2016,
WHEN THEN-VICE PRESIDENT BIDEN
LED THE CHARGE TO LAUNCH A NEW
INITIATIVE LED BY NCI TO
ACCELERATE DISCOVERY IN CANCER
RESEARCH TO FOSTER GREATER
COLLABORATION AND IMPROVE THE
SHARING OF DATA.
A BLUE RIBBON PANEL OF DIVERSE
LEADERS IN CANCER RESEARCH AND
CLINICAL CARE WAS CONVENED.
THIS PANEL SET SPECIFIC GOALS TO
GUIDE THE EFFORTS OF THE INITIAL
MOONSHOT THAT I WILL DETAIL
LATER AND WITH THIS FOCUS WE'VE
MADE REALLY TREMENDOUS PROGRESS
IN MANY AREAS, I'LL DESCRIBE
THEM IN A MINUTE.
THEN LAST YEAR PRESIDENT BIDEN
ANNOUNCED HIS INTENT TO BUILD ON
THE SEVEN-YEAR SUCCESS OF THE
INITIAL MOONSHOT AND REIGNITE
THE CANCER MOONSHOT SETTING SOME
VERY AMBITIOUS GOALS.
NUMBER ONE, REDUCE THE CANCER
AGE ADJUSTED MORTALITY RATE BY
50% IN 25 YEARS FOR U.S. PEOPLE.
AND TO IMPROVE EXPERIENCE OF
PEOPLE AND THEIR FAMILIES LIVING
WITH AND SURVIVING CANCER.
AND THIS MEANS MORE SUPPORT FOR
PATIENTS AND THEIR FAMILIES.
NEXT SLIDE PLEASE.
SO, ACHIEVING THE PRESIDENT'S
GOALS WILL TRANSFORM THE
NATIONAL EXPERIENCE OF CANCER.
THESE ARE NOT TRIVIAL GOALS.
THEY REALLY -- THE EFFORT IS TO
END CANCER AS WE KNOW IT.
AND RADICALLY CHANGE PEOPLE'S
EXPERIENCE WITH THIS TERRIBLE
DISEASE.
AND I'M VERY CONFIDENT WE CAN
ACHIEVE THESE GOALS AND REACH
THE DAY WHERE ALL PEOPLE WITH
CANCER LIVE FULL AND ACTIVE
LIVES FREE FROM ITS HARMFUL
EFFECTS.
AND WHERE WE PREVENT MANY MORE
CANCERS SO PEOPLE DON'T HAVE TO
FACE THIS CHALLENGE.
IT REALLY WILL TAKE ACTION
THOUGH ACROSS ALL OF SOCIETY TO
ACHIEVE THIS.
NEXT SLIDE.
CONGRESS PROVIDED SEVEN YEARS OF
FUNDING, THAT'S SCHEDULED TO END
THIS YEAR.
AND PRESIDENT BIDEN SUBMITTED A
BUDGET TO CONGRESS FOR 2024,
THAT WOULD HELP US AVOID THE
FUNDING CLIFF FOR MOONSHOT BY
PROVIDING ANOTHER $216 MILLION
FOR NEXT YEAR.
WHICH MATCHES THE AMOUNT THAT WE
CURRENTLY HAVE AVAILABLE FOR
2023.
HE ALSO PROPOSED $500 MILLION TO
INCREASE ACTIVITIES NEXT YEAR
AND ALSO A REAUTHORIZATION OF
THE 21ST CENTURY CURES ACT WITH
MANDATORY FUNDING FOR THE CANCER
MOONSHOT OF APPROXIMATELY
$1.45 BILLION FOR BOTH 2025 AND
2026.
YOU CAN SEE IN SIGNALING THIS
LEVEL OF FUNDING COMMITMENT THAT
PRESIDENT BIDEN IS VERY SERIOUS
ABOUT MAKING PROGRESS FOR
CANCER.
NEXT SLIDE.
SO TO GIVE A LOOK AT WHERE WE'VE
BEEN YOU'VE HEARD THE MONEY OF
THE INITIAL MOONSHOT WAS SPREAD
OVER SEVERAL YEARS, 2023 BUDGET
IS $216 MILLION.
AND WE ARE, AS YOU KNOW,
SUSTAINED, FUNDING IS REQUIRED
TO MAINTAIN PROGRESS.
WE HAVEN'T REACHED OUR ULTIMATE
GOAL, AND YOU CAN SEE BY THE
FUNDING CLIFF WE FACE WITH
MOONSHOT BUDGET THAT WAS
ESTABLISHED THROUGH 21ST CENTURY
CURES WHICH ENDS THIS YEAR CAN
BE SERIOUS.
IN LIGHT OF THE POLITICAL
SITUATION AFFECTING
CONGRESSIONAL APPOINTMENTS, WHAT
WILL COME NEXT YEAR IS ANYBODY'S
GUESS.
OF COURSE, WE'LL DO ALL THAT WE
CAN WITH WHATEVER WE HAVE
AVAILABLE TO US.
BUT I THINK IT'S ALSO REALLY
IMPORTANT WHEN YOU TAKE ON A
GOAL SUCH AS THAT ARTICULATED
WITH THE MOONSHOT, NCI'S BUDGET
ALONE CAN NEVER SUFFICE.
IT WILL TAKE COLLABORATION
ACROSS ALL OF GOVERNMENT AND ALL
OF SOCIETY TO SUCCEED.
MORE ON THIS IN A MINUTE.
NEXT SLIDE.
SO, WHAT KIND OF PROGRESS HAVE
WE MADE WITH MOONSHOT SO FAR?
GOOD NEWS, THIS HAS LAID A SOLID
FOUNDATION FOR PROGRESS FROM
WHICH WE CAN CAPITALIZE TO
ACCELERATE RESEARCH THAT WILL
BRING REAL SOLUTIONINGS TO
MILLIONS OF PEOPLE WHO FACE
CANCER, AND I'LL SPEAK FOR A BIT
NOW ON MOONSHOT HISTORY AND
HIGHLIGHT IMPORTANT ELEMENTS OF
THE PROGRESS.
NEXT SLIDE.
SO, INITIALLY THE INITIAL
MOONSHOT WAS BASED ON THESE TEN
RECOMMENDATIONS FROM A BLUE
RIBBON PANEL.
I'M NOT GOING TO READ EACH FOR
YOU.
YOU HAVE THEM IN YOUR MATERIALS,
BUT I DO WANT TO HIGHLIGHT THE
PEOPLE-CENTERED NATURE OF THESE
RECOMMENDATIONS.
NOT ONLY BUILDING NEW MORE
EFFECTIVE PREVENTION TREATMENT
AND SCREENING METHODS, BUT
DIRECTLY INVOLVING PEOPLE,
PATIENTS ARE PARTNERS WITH LIVED
EXPERIENCE, AND ADDRESSING THE
FACTORS THAT ALLOW THEM TO LEAD
FULL AND ACTIVE LIVES.
TO DATE THE MOONSHOT ENABLED NCI
TO SUPPORT MORE THAN 70
PROGRAMS, 250 RESEARCH PROJECTS,
AND THESE ARE CHANGED THE
LANDSCAPE OF WHAT IS POSSIBLE IN
CANCER RESEARCH TODAY AND LED TO
ADVANCES THAT BENEFIT PATIENTS.
AMONG THESE ARE IMPROVEMENT IN
IMMUNOTHERAPY, PROGRESS IN
CHILDHOOD CANCER RESEARCH,
EXPANDED USE OF PROVEN
STRATEGIES FOR CANCER PREVENTION
AND EARLY DETECTION TO BOTH
REDUCE CANCER RISK AND
IMPORTANTLY ALSO REDUCE
DISPARITIES.
THANKS TO POWERFUL NEW DATA
RESOURCES AND REALLY
UNPRECEDENTED COLLABORATION THAT
CAME AS RESULT OF THESE BLUE
RIBBON PANEL RECOMMENDATIONS,
WE'VE BEEN ABLE TO TRANSFORM
WHAT'S POSSIBLE, THROUGH THIS WE
OFFER THE COMMUNITY A WIDE RANGE
OF VALUABLE DATA RESOURCES,
ACROSS THE SPECTRUM OF CANCER
SCIENCE AND CLINICAL RESEARCH,
AS WELL AS NEW NETWORKS THAT ARE
COLLABORATING WITH TO PRODUCE
SIGNIFICANT SCIENTIFIC ADVANCES.
THIS IS WHAT I MEANT WHEN I SAID
IT REALLY HAS CHANGED THE
LANDSCAPE AND WE INTEND TO SEE
THIS GO FORWARD.
THE NCI HUMAN TUMOR ATLAS
NETWORK, PROGRAM GOAL CONSTRUCT
DYNAMIC THREE DIMENSIONAL LAT
ATLASES OF HUMAN CANCERS,
HELPING US BETTER UNDERSTAND
MOLECULAR AND CELLULAR NATURE OF
TUMORS NOT AT ONE TIME POINT BUT
AS THEY INITIATE AND EVOLVE.
ABSOLUTELY ESSENTIAL IF WE'RE
GOING TO BE ABLE TO BOTH PREVENT
AS WELL AS TREAT TUMORS.
THE GOAL IS TO FULLY
CHARACTERIZE TUMOR EVOLUTION
FROM EARLIEST LESIONS THROUGH
PRIMARY TUMOR TO RESISTANCE TO
METASTASIS TO DEVELOP PREDICTIVE
COMPUTATIONAL MODELS BASED ON
DETAILED MOLECULAR AND CELLULAR
CHARACTERIZATION OF TUMORS.
NEXT SLIDE.
YOU CAN SEE FROM THIS SLIDE THE
DIFFERENT TUMOR SITES THAT HAVE
NOW REAL DATA AND REAL RESOURCES
AS A RESULT OF HTAN, TRULY A
NATIONAL EFFORT.
EACH BOX IS A TEAM, COLORS
REPRESENT SIX DISEASE WITH DATA
FROM CANCER TO METASTATIC
DISEASE, IMPORTANTLY WITH
EXAMPLES OF TREATMENT EFFECTS.
IT'S COLOR CODED FOR DIFFERENT
APPROACHES, TAKEN FOR DIFFERENT
ORGAN SITES, DIFFERENT
TECHNOLOGIES IN USE, INCLUDING
CONVENTIONAL
IMMUNOHISTOCHEMISTRY, SINGLE
CELL STUDY, SPATIAL OMICS, AND
MANY OTHERS.
FOR EXAMPLE, WE HAVE AN EFFORT
IN PANCREATIC CANCER IN PURPLE
HERE ON THE LEFT, WHERE WE'RE
USING ALL OF THE DIFFERENT
TECHNOLOGIES AVAILABLE TO MAP
TUMOR EVOLUTION.
HEADINGS OF EACH BOX LIST
REFERENCES WHERE YOU CAN FIND
DETAIL CONCERNING THESE PROGRAMS
AND RESOURCES.
THESE ATLASES WILL BE FOLLOWED
IN THE NEXT YEAR AND A HALF BY
AT LEAST ANOTHER 20 DATA AND
INSIGHT-RICH ANALYSES AVAILABLE
TO THE BROAD COMMUNITY.
HTAN HAS PUBLISHED 12 ATLASES
DESCRIBING TRANSITION FROM
PRE-CANCER TO FULL MALIGNANCY,
LOCALLY INVASIVE TO METASTATIC
AND DEVELOPMENT OF THERAPY
RESISTANCE.
IN ADDITION TO THE NOW 12 MAIN
HTAN ATLASES AVAILABLE,
INVESTIGATORS HAVE CONTRIBUTED
161 MANUSCRIPTS OF WORK REPORTED
ALREADY.
NEXT SLIDE.
SO, THIS IS JUST ONE KEY PROGRAM
THAT IS ALLOWING US TO BEGIN TO
UNDERSTAND CELLULAR INTERACTIONS
THAT ARE OCCURRING WITHIN
TUMORS, HETEROGENEITY OF TUMORS
IN HUMAN POPULATIONS, AND HOW
THIS HETEROGENEITY GOVERNS
ARCHITECTURE AND THE EVOLUTION
AND DYNAMICS OF THE MANY
INTERACTIONS THAT OCCUR
INCLUDING RESPONSE TO TREATMENT.
THESE DATA WILL CONTINUE TO
GROW, AND WITH COMMITMENT BE
USED BY THE WIDEST POSSIBLE
COMMUNITY OF RESEARCHERS TO
INFORM TREATMENT, PREVENTION,
DIAGNOSTIC DISCOVERY.
NEXT SLIDE.
21ST CENTURY CURES ACT REQUIRES
THAT ALL MOONSHOT RESEARCH AND
THE DATA IT FUNDS TO BE MADE
PUBLICLY AVAILABLE IMMEDIATELY
UPON PUBLICATION, THEREFORE ALL
HTAN DATA ARE PUBLICLY AVAILABLE
AND WE PROVIDED THE URL HERE.
NEXT SLIDE.
ANOTHER MOONSHOT PROGRAM IS
IMMUNO-ONCOLOGY TRANSLATIONAL
WORKING TO ACCELERATE DISCOVERY
OF IMMUNE TARGETS FOR CANCER
TREATMENT AND DEVELOPMENT OF NEW
IMMUNOTHERAPIES.
WE UNDERSTAND THAT IMMUNE
RESPONSE TO TUMOR DEPENDS ON ALL
COMPONENTS OF THE IMMUNE SYSTEM,
ADAPTIVE, ESPECIALLY INCLUDING T
CELLS, B CELLS, DENDRITIC CELLS,
NATURAL KILLER CELLS, ALL THE
STROMAL COMPONENTS OF THE TUMOR
MICROENVIRONMENT, COMPLEX, AND
THEY ALL MATTER WHEN IT COMES TO
UNDERSTANDING HOW TO VERY MANY
EFFECTIVE IMMUNOTHERAPY.
CHECKPOINT INHIBITORS HAS DONE A
LOT FOR PATIENTS.
THEY CAN RELIEVE SOME OF THE
CHALLENGES CREATED BY TUMOR
IMMUNE SUPPRESSION BUT THEY ARE
NOT UNIVERSALLY EFFECTIVE.
CAR T CELLS ARE SHOWING ENORMOUS
PROMISE FOR SOME BUT NOT ALL
TUMORS.
SO NOW THROUGH THIS NETWORK
WE'RE EXPLORING NOVEL APPROACHES
TO STIMULATE ANTITUMOR RESPONSE,
FOR BOTH PREVENTION ALL THE WAY
THROUGH ADVANCED DISEASE TO
OVERCOME THE IMMUNOSUPPRESSIVE
MECHANISMS OF THE TUMOR.
AND FINALLY THERE'S A BIG EFFORT
I WANT TO CALL OUT TO IDENTIFY
NEW ANTIGENS AS WELL AS NOVEL
IMMUNE THERAPEUTIC TARGETS.
NEXT SLIDE.
WE'VE MADE PROGRESS.
WE'VE CREATED NEW RESEARCH
NETWORK, WE ARE PUBLICLY SHARING
DATA FROM THIS WORK SO FAR.
THERE HAVE BEEN 410 MANUSCRIPTS
PUBLISHED FROM THIS EFFORT AT
LAST COUNT.
AND MOST IMPORTANTLY, NEW
COLLABORATIONS TO BRIDGE
IMPORTANT CLINICAL GAPS IN
IMMUNO-ONCOLOGY.
IN ADDITION TO RESEARCH, THE
MOONSHOT HAS BEEN SUPPORTED
EFFORTS IN IMMUNOPREVENTION,
IMMUNOENGINEERING AS THERAPEUTIC
MODALITY AND EFFORTS TO MITIGATE
IMMUNOTHERAPY MEDIATED ADVERSE
EVENTS.
NEXT SLIDE.
ANOTHER HIGHLIGHT FOR YOU,
CHILDHOOD CANCER WAS A MAJOR
FOCUS, SINCE MANY DISEASES ARE
FUNDAMENTALLY DIFFERENT FROM
ADULT CANCERS IN UNDERLYING
BIOLOGY, AND RESPONSE TO
TREATMENT.
WE LEARNED OVER AND OVER AGAIN
CHILDREN ARE NOT JUST SMALL
ADULTS.
ABOUT HALF OF ALL CHILD CANCERS
ARE CAUSED BY SLICING, FUSED
PROTEINS MUTATES ONCOGENIC
SIGNALING.
FUSION ONCOPROTEIN 2 CONSORTIUM
WAS LAUNCHED TO UNDERSTAND HUE
FUSION ONCOPROTEINS DRIVE
TUMORIGENESIS AND DEVELOP SMALL
MOLECULES.
WE FUNDED NINE CENTERS, COVERING
SIX IDENTIFIED FUSION
ONCOPROTEINS IN HIGH RISK
CHILDHOOD CANCERS.
IT'S BEEN HIGHLY SUCCESSFUL IN
CHARACTERIZING THE MOLECULAR
MECHANISMS BY WHICH FUSION
ONCOPROTEINS HIJACK THE
TRANSCRIPTIONAL MACHINERY, AND
THESE GROUPS HAVE MADE THE
SURPRISING FINDING THREE
DIFFERENT FUSION ONCOPROTEINS
DERIVED FROM DIFFERENT GENE
FUSIONS SHARE A COMMON MECHANISM
OF ACTION, BECAUSE EACH ONE
REGULATES -- DYSREGULATES,
SORRY, CHROMATIN ARCHITECTURE TO
ENABLE EXPRESSION OF GENES
NORMALLY TRANSCRIPTIONALLY
SILENCED, LEADING TO
UNCONTROLLED GROWTH, LEADING TO
DEVELOP SMALL MOLECULES TO
DISRUPT.
WE'VE ALL TALKED ABOUT THIS,
DATA SHARING IS ABSOLUTELY
CRITICAL TO ACHIEVING OUR GOALS.
AND I'M HAPPY TO SAY WE CAN
PROVIDE SOME RESOURCES TO THE
COMMUNITY THROUGH THE FUNDING
AND EFFORTS OF THE MOONSHOT.
WE'RE CREATING NATIONAL CANCER
DATA ECOSYSTEM THAT WE'LL
CONTINUALLY EXPAND TO MAXIMIZE
DATA UTILITY MAKING IT EASIER
FOR PEOPLE ACROSS THE CANCER
RESEARCH AND IMPORTANTLY CARE
CONTINUUM TO SHARE ACCESS AND
ANALYZE DATA.
NCI IS BUILDING A CANCER
RESEARCH DATA COMMONS, IT'S
AVAILABLE, IT WILL CONTINUE TO
GROW AND EXPAND AS AN
INFRASTRUCTURE TO SUPPORT DATA
COLLECTION AND USE FOR THE
ENTIRE RESEARCH COMMUNITY.
THE CDRC LEVERAGES COMPUTING
POWER OF THE CLOUD CURRENTLY TO
OFFER VIRTUE DATA SCIENCE
INFRASTRUCTURE, CONNECTING
CANCER RESEARCH DATA COLLECTIONS
WITH ANALYTIC TOOLS.
AND IT CAN TODAY BE USED BY
RESEARCHERS TO STORE, ANALYZE TO
IMPROVE OUR UNDERSTANDING, I
WILL EMPHASIZE AGAIN I THINK WE
AT THE INITIAL LET'S SAY BABY
STEPS OF WHAT IT WILL TAKE TO
REALLY SHARE DATA AT THE SCALE
AND FUNCTIONAL CAPACITY THAT WE
WANT, BUT WE'VE MADE A START AND
IT CAN HELP PEOPLE ACHIEVE
RESULTS.
NEXT SLIDE.
ONE OF THE KEY COMPONENTS OF THE
COMMONS THAT'S BEEN EVOLVING
OVER MANY YEARS IS THE GENOMIC
DATA COMMONS.
IT PROVIDES CANCER RESEARCH
COMMUNITY WITH UNIFIED
REPOSITORY AND CANCER KNOWLEDGE
BASE TO ENABLE DATA SHARING
ACROSS CANCER GENOMIC STUDIES IN
SUPPORT OF PRECISION MEDICINE,
SUPPORTING SEVERAL PROGRAMS AT
THE 1999 NCI CENTER.
AS YOU CAN SEE, TODAY THE
COMMONS CONTAINS GENOMIC DATA
FOR 68 CANCER SITES, ALMOST
87,000 CANCER CASES, AND CLOSE
TO 3 MILLION ASSOCIATED
MUTATIONS.
IT ALSO TODAY QUITE A RESOURCE
THAT CONTINUES TO EXPAND.
THIS BEGAN UNDER THE INITIAL
MOONSHOT.
WE'LL CONTINUE TO INVEST IN DATA
SHARING INFRASTRUCTURE
THROUGHOUT OUR ACTIVITIES AS
PART OF THE NATIONAL CANCER PLAN
WHICH I'LL COME BACK TO SHORTLY.
SO, WHEN PRESIDENT BIDEN
REIGNITED THE MOONSHOT A YEAR
AGO HE GAVE US THE CHARGE TO
ACHIEVE EACH ACTION HERE.
AND THIS IS EXACTLY RIGHT.
EACH OF THESE THINGS MUST HAPPEN
IF WE'RE GOING TO END CANCER AS
WE KNOW IT.
NEXT SLIDE.
AS PART OF HIS COMMITMENT TO A
WHOLE-OF-GOVERNMENT APPROACH HE
BEGAN BY CONVENING A CANCER
CABINET LAST YEAR TO BRING
TOGETHER DEPARTMENTS AND
AGENCIES ACROSS THE FEDERAL
GOVERNMENT TO COORDINATE ACTION.
THESE INCLUDED HEALTH FOCUSED
AGENCIES LIKE HHS, NIH, HRSA,
CMS, BUT ALSO OTHERS WITH
ACTIONS AND EXPERTISE, EPA,
DEPARTMENT OF DEFENSE, EVEN
NASA.
WE'RE SEEING IMPORTANT NEW
ACTIONS TAKEN BY CABINET
MEMBERS.
HRSA SPONSORING AWARDS THAT
BRING COMMUNITY HEALTH CENTERS
TOGETHER WITH NCI DESIGNATED
CANCER CENTERS TO FACILITATE
ACCESS TO EARLY DETECTION
SERVICES FOR UNDERSERVED
COMMUNITIES.
AND HHS, OFFICE OF THE NATIONAL
COORDINATOR AND OFFICE OF THE
ASSISTANT SECRETARY FOR HEALTH,
ARE LAUNCHING A PROGRAM KNOWN AS
CANCER-X, A PUBLIC/PRIVATE
PARTNERSHIP TO ACCELERATE
BIOTECH AND HEALTH TECH START-UP
SOLUTIONS FOCUSED ON PREVENTION,
DETECTION, TREATMENT, AND
TRANSITION AND CARE.
NEXT SLIDE.
WE DON'T HAVE FUNDING MORE THE
FOON SHOT BEYOND OF OF OF --
MOONSHOT BEYOND 2023 WE'RE USING
CURRENT FUNDS TO THE FULLEST
EXTENT.
THE TRACE PROGRAM AWARDED $23
MILLION TO FOUR CENTERS TO
ESTABLISH THEM AS CENTERS
EXCELLENCE TO STUDY TELEHEALTH,
WE LEARNED A LOT DURING THE
PANDEMIC ABOUT HOW EFFECTIVE
TELEHEALTH APPROACHES CAN MAKE
IT EASIER FOR PEOPLE TO
PARTICIPATE IN SOME TYPES OF
RESEARCH LIKE CLINICAL TRIALS.
AND TO ACCESS HEALTH CARE.
THESE AWARDS ARE A COMMITMENT TO
HELPING US UNDERSTAND HOW TO
BEST USE THIS TECHNOLOGY, TO
ADDRESS THE NEEDS OF OUR
PATIENTS, AND EXPAND THEIR
PARTICIPATION AND RESEARCH.
UNFORTUNATELY, WE STILL HAVEN'T
REACHED LEVEL OF DIVERSITY WE
FEEL IS NEEDED AMONG OUR R01
GRANTEES.
THE CANCER MOONSHOT SCHOLARS
PROGRAM IS DESIGNED TO ADDRESS
THIS WITH THE AIM TO ADVANCE
CANCER SCIENCE WHILE ALSO
DIVERSIFYING THE POOL OF
RESEARCHERS AND PERSPECTIVESES
AND APPROACHES TO INCREASE
NUMBER OF APPLICATIONS TARGETED
TO EARLY STAGE INVESTIGATORS
FROM DIVERSE BACKGROUNDS, AND WE
EXPECT TO BE FUNDING 45 NEW
R01s THROUGH THIS PROGRAM OVER
THE NEXT THREE YEARS.
A THIRD IS NCI MULTI-CANCER
DETECTION TEST VANGUARD STUDY,
FOR MANY CANCERS, PANCREATIC,
BRAIN TUMORS, OVARIAN CANCER, WE
JUST DON'T HAVE MEASURES TO
ALLOW EARLY DETECTION.
EVEN THOUGH WE KNOW EARLY
DETECTION CAN SAVE LIVES.
THESE TESTS ARE CONDUCTED
THROUGH SIMPLE BLOOD DRAW, MAY
PROVIDE LESS INVASIVE MEANS FOR
EARLY DETECTION AND BETTER
OUTCOME, THIS WILL EVALUATE
WHETHER BENEFITS OF USING MCD
APPROACH TO SCREEN FOR CANCER
WILL OUTWEIGH HARMS,
OVERDIAGNOSIS IS A REAL ISSUE,
PARTICULARLY IN OUR AGING
PATIENT POPULATIONS.
SO, THE PLAN IS TO BEGIN
ENROLLING 24,000 HEALTHY PEOPLE,
AGES 45 TO 70, IN 2024 TO LAY
THE GROUND WORK FOR THE LARGER
STUDY THAT IS REQUIRED THAT WILL
ENROLL 225,000 PEOPLE TO
DEMONSTRATE BENEFIT FOR THIS
TYPE OF SCREENING ACROSS ALL
CANCERS, WITH THE ENPOINT BEING
REDUCED MORTALITY.
WE NEED TO MAKE FASTER PROGRESS
AGAINST THE MOST COMMON CANCERS
BUT ALSO ACHIEVE BETTER RESULTS
FOR ALL PEOPLE WITH ALL OTHER
CANCERS IF WE'RE GOING TO OBTAIN
THE PRESIDENT'S 25 MORTALITY
RATE BY 2047.
OUR CURRENT RATE OF DECLINE IN
CANCER DEATHS PER YEAR BASED ON
CURRENT DATA IS 2.3%.
ANALYSIS SAYS WE NEED TO GET TO
A SUSTAINED RATE OF DECLINE OF
2.7% PER YEAR OVER THE NEXT 25
YEARS TO MEET THIS GOAL.
SOUND LIKE IT'S NOT SO HARD.
WOW!
WHEN YOU LOOK AT THE MODELING
AND THE DATA, BASED ON WHAT HAS
COME BEFORE AND WHAT WE NEED TO
DO NEXT, IT IS NOT EASY AT ALL.
IT IS GOING TO TAKE A
SIGNIFICANT COMMITTED COLLECTIVE
ACTION FROM ALL OF US, INCLUDING
SOCIETAL CHANGES BEYOND THE
BIOMEDICAL COMMUNITY IF WE'RE
GOING TO REACH THIS GOAL.
NEXT SLIDE.
NEXT SLIDE PLEASE.
SO, THIS IS WHY THE NATIONAL
CANCER PLAN.
THE NATIONAL CANCER ACT OF 1971
WAS IMPORTANT, SHAPING WHAT THE
NATIONAL CANCER INSTITUTE IS
TODAY, GRANTED NEW AUTHORITY,
CREATED CRITICAL INFRASTRUCTURE,
INCREASED FUNDING FOR CANCER
RESEARCH, BUT ALSO GAVE THE
AUTHORITY OF THE NCI DIRECTOR TO
PLAN AND DEVELOP A NATIONAL
CANCER PROGRAM THAT INCLUDED NCI
AND OTHER RESEARCH INSTITUTES
AND OTHER FEDERAL AND
NON-FEDERAL PROGRAMS, TWO ROLES
TO LEAD THE INSTITUTE BUT ALSO
TO DEVELOP AND IMPLEMENT
NATIONAL CANCER PLAN.
SO, IT IS IN THIS LIGHT THAT WE
IN COLLABORATION WITH SO MANY
CRITICAL COLLEAGUES ACROSS THE
OTHER NIH INSTITUTES AND CENTERS
ALSO THE OTHER AGENCIES OF
HEALTH AND HUMAN SERVICES TO
CREATE A NEW NATIONAL CANCER
PLAN.
WHAT IS THIS?
NEXT SLIDE.
THIS PLAN EMBRACES THE IDEA THAT
TO END CANCER AS WE KNOW IT
EVERYONE HAS TO HELP INCLUDING
EVERYONE THROUGHOUT THE CANCER
SCIENCE CONTINUUM ACROSS BASIC
TRANSLATIONAL AND CLINICAL
RESEARCH.
HOWEVER, IT WILL TAKE MORE THAN
JUST RESEARCH.
WE WILL REQUIRE CONTRIBUTIONS
FROM OTHER FEDERAL AGENCIES,
INDUSTRY, ACADEMIA, INDUSTRY,
CAREGIVERS, PATIENTS, FAMILY
MEMBERS, REALLY ALL ASPECTS OF
SOCIETY, AND TO DO THIS WE HAVE
TO FIND NEW WAYS TO WORK
TOGETHER.
AND TAKE FULL ADVANTAGE OF
EVERYONE'S COLLECTIVE RESOURCES,
EXPERTISE, AND EXPERIENCE.
SO, IN THIS WAY THE NATIONAL
CANCER PLAN CAN'T BE JUST A
PRODUCT BUT HAS TO BE A PROCESS
TO HELP US FIND THE WAY WE NEED
TO WORK TOGETHER.
NEXT SLIDE.
SO DEVELOPED WITH SO MANY
WONDERFUL COLLEAGUES ACROSS THE
SPECTRUM, THERE ARE EIGHT GOALS.
YOU CAN SEE THE HEADINGS.
BUT THESE GOALS ALIGN WITH THE
REIGNITED MOONSHOT GOALS.
THEY WERE DESIGNED AS A -- WHAT
WOULD SUCCESS LOOK LIKE, WHAT DO
WE REALLY NEED TO ACHIEVE IF
WE'RE GOING TO END CANCER?
THE LARGER PLAN ON THIS WEBSITE,
IT ALSO DESCRIBES THE CURRENT
STATE OF THE CANCER WORLD FOR
EACH OF THESE GOALS, WHAT
SCIENTIFIC OR SOCIETAL
CHALLENGES EXIST, WHAT IS
POSSIBLE AND NEEDED TO DO
BETTER, AND WE INCLUDE WHERE NCI
IS MAKING A COMMITMENT TO MAJOR
CONTRIBUTIONS TO EACH.
WE ENVISION THROUGH GUIDANCE OF
THE PRESIDENT'S CANCER PANEL
THAT THIS PLAN WILL BE A LIVING
DOCUMENT THAT WE WILL REVISE AS
NEW OPPORTUNITIES AND NEEDS
ARISE OVER OUR 25-YEAR TIME
FRAME TO ACHIEVE THE GOALS OF
THIS NEW MOONSHOT.
NEXT SLIDE.
I'LL GIVE QUICK EXAMPLES OF
NCI'S CONTRIBUTIONS TO THE
NATIONAL CANCER PLAN.
WE'RE COMMITTED TO DOING
EVERYTHING WE CAN TO POWER
RESEARCH ACROSS THE SPECTRUM
FROM BASIC DISCOVERY TO CLINICL
RESEARCH.
WITHOUT ADEQUATE PARTICIPANT
REPRESENTATION IN CANCER
RESEARCH, ESPECIALLY IN
THERAPEUTIC TRIALS, DISPARITIES
ARE LIKELY TO INCREASE AS RACIAL
AND ETHNIC POPULATIONS MAY NOT
BE ABLE TO FULLY BENEFIT FROM
CUTTING EDGE TREATMENT AND
PROMISES OF PRECISION MEDICINE.
ONE PROGRAM KNOWN AS CONNECTING
UNDERREPRESENTED POPULATIONS TO
CLINICAL TRIALS, ADDRESSES KEY
ISSUES THAT AFFECT DIVERSITY IN
TRIALS AND WILL IMPROVE THE
DISSEMINATION OF INFORMATION AND
CARE N. INTO UNDERSERVED
COMMUNITIES WHERE THEY ARE
NEEDED MOST. YOU CAN'T DO
CLINICAL RESEARCH WHERE YOU
CAN'T DO CLINICAL CARE.
THEY GO HAND IN HAND.
IF WE HOPE TO REACH -- I'M
SORRY, GO BACK.
IF WE HOPE TO ACHIEVE LEVEL OF
RESEARCH PARTICIPATION REQUIRED
WE MUST EMPOWER RESEARCHERS NOT
JUST AT THE MAIN HUBS, LIKE
PROGRAMS LIKE THE RESEARCH
PROGRAM ARE SO IMPORTANT BECAUSE
NCCOR, WHICH HAS BEEN AROUND FOR
MORE THAN A DECADE, EXTENDS THE
REACH OF CLINICAL TRIALS INTO
THE COMMUNITIES WHERE PEOPLE
ACTUALLY LIVE, TO BRING CARE AND
RESEARCH TO THEM.
NEXT SLIDE.
A NEW NCI INITIATIVE THAT GOES
BY SHORT HAND, CC-DIRECT, BRINGS
CLINICAL NAVIGATION AND CARE
NAVIGATION TO SUPPORT CHILDREN,
ADOLESCENTS, YOUNG ADULTS WITH
CANCER IN FAMILIES.
IT WILL ALSO FACILITATE RESEARCH
PARTICIPATION AND IMPORTANTLY WE
WERE TALKING ABOUT DATA SHARING
STANDARDS BEFORE, WELL, IT WILL
ESTABLISH A PORTABLE SHAREABLE
STANDARDIZED CANCER HEALTH
RECORD FOR KIDS, ADOLESCENTS,
YOUNG ADULTS.
IT STANDS OUT BECAUSE IT
REPRESENTS A FIRST OF ITS KIND
PUBLIC/PRIVATE PARTNERSHIP
BETWEEN NCI AND EIGHT PARTNER
ORGANIZATIONS SPANNING
GOVERNMENT, NON-PROFIT,
RESEARCH, CLINICAL PRACTICE
SECTORS WHICH IS WHAT WE NEED TO
DO IF WE'RE GOING TO DEVELOP A
STANDARD SUCH AS THIS
GENERALIZABLE HEALTH RECORD THAT
CAN WORK FOR ALL.
WE WANT TO ALSO DO WHAT WE CAN
TO ENSURE THE FAMILY OF EVERY
CHILD WITH CANCER IS CONNECTED
TO THE KNOWLEDGE AND RESOURCES
REQUIRED TO ACCESS AND
PARTICIPATE IN RESEARCH.
NEXT SLIDE.
NCI HAS BEEN DOING CLINICAL
TRIALS SINCE 1954.
HOWEVER, WE SEE A GREAT NEED
WITH ALL THIS EXPERIENCE TO
EXPAND AND MODERNIZE CANCER
CLINICAL TRIALS TO PRODUCE
BETTER DATA, MORE QUICKLY.
WE NEED THIS TO ACHIEVE THE
GOALS.
WE'RE LOOKING AT HOW WE DESIGN
CLINICAL TRIALS FROM TOP TO
BOTTOM, TO DETERMINE HOW WE CAN
ENROLL PEOPLE FROM VERY DIVERSE
POPULATIONS, PRODUCE RESULTS
FASTER, SO THESE RESULTS CAN BE
MORE QUICKLY ADOPTED FOR WIDER
BENEFIT.
IN ORDER TO INNOVATE AND BREAK
THE MOLD AND TAKE SOME RISKS WE
NEED TO TAKE, IN ORDER TO
INNOVATE, WE DECIDED TO PROVIDE
A DEDICATED TEAM AT NCI TO
PARTNER WITH THE FAULD -- FDA
AND LEADERS OF CLINICAL TRIALS
GROUPS, LAUNCHED IN FEBRUARY
KNOWN AS THE CLINICAL TRIALS
INNOVATION UNIT, SELECTING
HIGH-PRIORITY SCIENTIFIC
QUESTIONS THAT ARE PARTICULARLY
AMENABLE TO RADICALLY NEW STUDY
DESIGNS AND OPERATIONAL
PROCEDURES, AND THEN CARRY THEM
FORWARD THROUGH THE ESTABLISHED
NATIONAL CLINICAL TRIALS
NETWORK..
WE'RE NOW ACCEPTING OUR FIRST
ROUND, NOW THROUGH JUNE 12.
I NEED TO EMPHASIZE ALL ASPECTS
OF CLINICAL TRIALS ARE ON THE
TABLE.
EVERYTHING THAT CAN BE ADAPTED
TO ACHIEVE MORE DIVERSE AND
FASTER BENEFIT FOR PEOPLE IS UP
TO INNOVATION BY THIS NEW
PROGRAM SUCH AS BETTER WAYS TO
ENGAGE IMPORTANT POPULATIONS,
NEW DATA COLLECTION METHODS, AND
EVEN BETTER WAYS TO MEASURE
BENEFIT FOR PEOPLE.
OUR AIM IS FOR TRIALS TO SET NEW
STANDARDS FOR HOW PARTICULAR
CANCER RESEARCH QUESTIONS ARE
ADDRESSED, TO HELP US GET
ANSWERS FASTER AND MORE
EFFECTIVELY, AND THIS WILL MAKE
A DIFFERENCE TO HELP US OVERCOME
THE CHALLENGES THAT WE
EXPERIENCE WITH TRIALS AND
CREATE MORE OPPORTUNITIES FOR
PROGRESS.
NEXT SLIDE.
SO AN EXAMPLE, YOU MIGHT HAVE
HEARD ABOUT THE PRAGMATICA-LUNG
STUDY LAUNCHED, NOW ENROLLING
PARTICIPANTS.
ON ITS FACE, IT IS A
REGISTRATION TRIAL DESIGNED TO
ANSWER A VERY STRAIGHTFORWARD
QUESTION, FOR SOME PEOPLE WITH
NON-SMALL CELL LUNG CANCER IS
COMBINATION OF TWO TARGETED
THERAPIES BETTER AT PROLONGING
LIFE THAN CURRENT STANDARD
THERAPIES?
BUT THIS TRIAL IS TESTING WAYS
TO GET THE RESULTS, AGAIN A
REGISTRATION TRIAL, PRODUCING
DATA FOR FDA REVIEW, BUT DO IT
MUCH FASTER.
IT'S FOCUSED ON RAPIDLY ENGAGING
PATIENTS, PARTICULARLY THOSE
FROM POPULATION ALSO TOO OFTEN
LEFT OUT OF CLINICAL TRIALS WHO
FACE SOCIETAL BARRIERS AND
FRANKLY ARE ALSO THE PEOPLE AT
GREATEST RISK FOR NON-SMALL CELL
LUNG CANCER IN THE FIRST PLACE,
ELIGIBILITY CRITERIA ARE BROAD
SO WE DON'T EXCLUDE PEOPLE WHO
CAN BENEFIT, FOCUSED ON ONLY
DATA ESSENTIAL TO ANSWER THE
QUESTION ABOUT IMPACT ON
SURVIVAL, SIMPLICITY IS THE KE.
I WILL TELL YOU THIS PROJECT,
THIS IDEA, FIRST LANDED AT THE
REVIEW AS A POSSIBILITY, AT THE
END OF AUGUST 2022.
AND IT OPENED TO ENROLLMENT IN
MARCH.
THAT INCLUDED NOT ONLY
COLLABORATION WITH ALL THE
PARTNERS REQUIRED TO DEVELOP THE
STUDY, IT ALSO INCLUDED
INVESTMENT AND BUY-IN FROM TWO
DIFFERENT PHARMACEUTICAL
COMPANIES.
SO, WE CAN DO THINGS REALLY
QUICKLY IF WE HAVE THE RIGHT
PARTNERS.
WE'RE ASKING EVERYONE TO HELP US
CHAMPION THE NATIONAL CANCER
PLAN SO IT BECOMES PART OF
DECISION MAKING AND THEY
COMMUNICATE WITH US SO WE KNOW
WHAT TO DO BETTER.
WE CAN REALLY OVERCOME THE
STRUCTURAL AND SOCIETAL BARRIERS
THAT LED TO SUBSTANTIAL
DISPARITIES IN CANCER INCIDENCE
AND MORTALITY AND LIMIT SOME
PARTICIPATION IN SCIENCE.
WE'RE ALSO ASKING THAT EVERYONE
KEEP US INFORMED OF THOSE
ACTIVITIES, NEW AND ONES
UNDERWAY, THAT ALIGN WITH GOALS.
THE INTENTION IS TO BREAK DOWN
BARRIERS.
TO COLLABORATION, SO WE CAN BEST
SUPPORT AND AMPLIFY THIS
IMPORTANT WORK.
I HOPE THROUGH ALL THE EXAMPLES
I'VE GIVEN YOU, YOU CAN SEE THAT
IN EVERY SINGLE BIT OF THE
MOONSHOT THE THEME IS
COLLABORATION AND BREAKING DOWN
BARRIERS.
I'LL WRAP UP.
A LOT IS HAPPENING.
WE'RE TAKING DELIBERATE STEPS TO
ENSURE WE PUT PEOPLE AT THE
CENTER OF EVERYTHING THAT WE DO.
AND THAT WE'RE ON THE RIGHT PATH
TO DELIVER THE BEST POSSIBLE
CANCER RESEARCH RESULTS FOR THE
PEOPLE WHO NEED IT MOST.
I PERSONALLY HAVE SEEN A
DRAMATIC CULTURE CHANGE DURING
MY CAREER.
FROM RESEARCHERS FOCUSED
ENTIRELY ON INDIVIDUAL
SCIENTIFIC GOALS TO ONE WHERE WE
HAVE TODAY WHERE ALL THROUGHOUT
RESEARCH ARE ENGAGED MEMBERS OF
A COMMUNITY THAT INCLUDES THOSE
PEOPLE WE SERVE AS ESSENTIAL
PARTNERS, AND THIS IS TRULY
MOVING US FORWARD AS NEVER
BEFORE.
SO I'M EXCITED ABOUT THE
POTENTIAL FOR ALL OF US TOGETHER
AND ALL THAT WE'LL ACHIEVE, AND
SO NOW I'D LIKE TO GET TO THE
BEST PART, YOUR QUESTIONS.
THANK YOU SO MUCH.
>> GISELLE AND LUCILA.
>> THANK YOU SO MUCH FOR YOUR
PRESENTATION.
I'M GRATEFUL TO BE HERE AS A NEW
MEMBER OF THE ACD.
AND SO I'VE LISTENED WITH MUCH
INTEREST TO YOUR PRESENTATION.
I WAS REALLY HAPPY TO HEAR OF
THE WAYS IN WHICH HEALTH EQUITY
OR INEQUALITY, HEALTH
DISPARITIES, ACTUALLY WERE
ACTUAL INTEGRATED IN SOME PARTS,
PARTICULARLY OF THE CANCER -- OF
THE NATIONAL CANCER PLAN.
IT SEEMS LIKE A LOT HAS TO DO,
WHAT YOU DESCRIBED, OFTEN
FOCUSED ON INTEGRATION,
INCLUSIVE CLINICAL TRIAL
PARTICIPATION, WHICH IS NEAR AND
DEAR TO MY HEART, IT'S WHAT I
STARTED DOING EARLY ON.
AND DEVELOPED INTERVENTIONS
AROUND CANCER PARTICIPATION AND
CANCER CLINICAL TRIALS WITH
COMMUNITY MEMBERS ACROSS NORTH
CAROLINA.
THE REALITY IS TO GET TO THE
POINT, TO GET TO THAT POINT 4%
DROP THAT YOU'RE DESCRIBING
THERE NEEDS TO BE EVEN GREATER
EMPHASIS ON POPULATIONS
DISPROPORTIONATELY IMPACTED BY
CANCER MORBIDITY AND MORTALITY.
I WONDER IF YOU COULD SAY MORE
ABOUT HOW THAT EMPHASIS,
IMPORTANT AND NEEDED EMPHASIS,
BEYOND CLINICAL TRIALS
PARTICIPATION, WILL SHOW UP IN
THIS NEWEST ITERATION OF THE
MOONSHOT, AND THEN A SECOND
QUESTION WHICH I'M HAPPY TO ASK
NOW OR WAIT ON, THAT HAS TO DO
WITH COLLABORATION ACROSS
INSTITUTES.
>> TERRIFIC.
I LOVE THIS QUESTION.
SO, BECAUSE IT EXEMPLIFIES HOW
THE MOONSHOT IS DIFFERENT AND
NEEDS MORE AND IS BEYOND NCI
ALONE, YOU HEARD ME SAY YOU
CAN'T DO CLINICAL RESEARCH UNTIL
YOU CAN DO CLINICAL CARE.
YOU HAVE TO REMOVE -- WELL, WE
CAN RESEARCH INEQUITIES, WE KIND
OF KNOW THERE ARE INEQUITIES OUT
THERE AND CAN RESEARCH THEM AND
DO RESEARCH ON WAYS TO OVERCOME
THEM, THAT'S WONDERFUL.
BUT WE WANT TO BRING THE FULL
SPECTRUM OF RESEARCH TO
EVERYONE.
SO IT'S GOT TO BE EVERYTHING WE
DO LAST TO BE FULLY INTEGRATED
INTO THE HEALTH CARE DELIVERY
SYSTEM.
AND WE NEED ALL OF THE OTHER
PARTNERS WHO ARE WORKING ON
IMPROVING HEALTH CARE DELIVERY
OVERALL TO WORK WITH US, TO
BRING THE RESEARCH PARTICIPATION
TO THOSE POPULATIONS.
I THINK THE HRSA EXAMPLE IS A
SIMPLE ONE THAT EVERYBODY CAN
GRAB, FEDERALLY QUALIFIED HEALTH
CENTERS, SCREENING FOR MAJOR
CANCERS TO EVERYONE WHO WALKS IN
THE DOOR, WHAT IF THEY ARE
DIAGNOSED WITH A CANCER?
NOW THEY HAVE TO GO SOMEWHERE TO
GET THEIR TREATMENT.
LINKING THOSE SCREENING CENTERS
WITH THE NCI DESIGNATED CANCER
CENTERS AS THE LINK TO GET THE
CARE THEY NEED IN A CANCER
INSTITUTE-FUNDED ENVIRONMENT,
THAT'S A REALLY GREAT
COLLABORATION RIGHT THERE.
WE'RE LOOKING FOR MANY MORE OF
THOSE KINDS OF IDEAS.
AND FINALLY, THE ISSUE OF
DISPARITIES.
I GREW UP IN A RURAL
ENVIRONMENT, 100 MILES FROM THE
NEAREST HOSPITAL.
I UNDERSTAND NOR KIND OF
INEQUITY, JUST NO ACCESS BECAUSE
IT'S TOO FAR AWAY.
WHAT THAT IS TELLING ME THERE'S
SO MANY DIFFERENT VERSIONS OF
THIS PROBLEM, AND ONE THING WE
LEARNED, THIS IS WHY NCCOR IS
PRECIOUS TO US, THE SOLUTION FOR
EVERY INEQUITY IS GOING TO BE
SPECIFIC TO EVERY POPULATION AND
EVERY PLACE.
>> ABSOLUTELY.
>> WE HAVE TO BE COMMITTED TO
ALL OF THAT.
THAT'S WHY ALL THESE INDIVIDUAL
COMMUNITY SOLUTIONS ARE KEY, AND
WE'RE NEVER GOING TO FIND THOSE
UNLESS THOSE COMMUNITIES ARE OUR
PARTNERS.
>> THANK YOU.
>> THAT'S WHERE WE ARE.
>> THANK YOU FOR IN A.
>> THANKS FOR YOUR HELP BECAUSE
WE'RE GOING TO NEED A LOT OF
HELP.
>> AS A PRIMARY CARE PHYSICIAN
WHO PRACTICES IN A FEDERALLY
QUALIFIED COMMUNITY HEALTH
CENTER I WAS EXCITED TO HEAR
HRSA EXAMPLE.
MY QUESTION HAS TO DO WITH
COLLABORATION WITH ACROSS NIH
ALSO.
WHEN YOU LOOK AT THE RISK
FACTORS FOR CANCERS, MOST
CANCERS, RISK FACTORS ARE THE
SAME FOR MANY CHRONIC ILLNESSES.
AND, AGAIN, AS WE THINK ABOUT
THE INEQUALITIES AS ONE LEVER
THAT WE CAN PULL, IN ADDRESSING
AND TRYING TO GET TO OUR GOAL IN
THAT MARK, IN TERMS OF THE
MOONSHOT AND REDUCTION IN CANCER
AS WE KNOW IT, I WONDER ABOUT
THE COLLABORATION ACROSS THE NIH
INSTITUTE AND HOW THAT CAN BE
LEVERAGED AS WELL, AGAIN
PARTICULARLY VIS-A-VIS WHEN WE
THINK ABOUT POPULATIONS THAT MAY
HAVE DISPROPORTIONATELY IMPACTED
BY THEIR ENVIRONMENTAL FACTORS
AS WELL AS BEHAVIORAL FACTORS AS
CONTRIBUTORS TO CANCER RISK AND
MORBIDITY AND MORTALITY.
>> SO OF COURSE YOU DON'T WALK
INTO A SITUATION AND YOU SAY,
ANYWHERE, WE'RE ONLY INTERESTED
IN YOUR CANCER PROBLEM.
AND WE ALSO KNOW THAT CANCER, IF
WE JUST TAKE THE ISSUE OF CANCER
IT GOES DEEP INTO LET
EVERYWHERE, FROM MENTAL HEALTH
THROUGH -- I CAN LIST EVERYTHING
THAT THE NIH DOES, IT IS
RELEVANT TO CANCER.
ONE OF THE REALLY WONDERFUL,
WONDERFUL THINGS ABOUT MY TENURE
NOW AS BEING PART OF THE NIH HAS
BEEN TO SEE THE AMAZING
WILLINGNESS OF THE OTHER
INSTITUTE DIRECTORS TO WORK ON
PROBLEMS LIKE THIS TOGETHER.
WE SHALL JUST STARTING.
THE CANCER PLAN WAS ANNOUNCED IN
MARCH. THERE WERE MANY
CONTRIBUTORS FROM ACROSS THE
OTHER I.C.s TO THE PLAN
ITSELF.
AND NOW WE'RE REALLY STARTING TO
GET INTO DETAILS OF HOW WE ARE
GOING TO WORK TOGETHER AND
LEVERAGE EVERYTHING THAT WE HAVE
TO THE BENEFIT OF ALL.
ANOTHER QUICK EXAMPLE, THINK
ABOUT THE ISSUE OF AUTOIMMUNE
DISEASE.
YOU MIGHT THINK THAT HAS NOTHING
TO DO WITH CANCER.
EVERYTHING WE'RE DOING IN
IMMUNOTHERAPY AND SEEING THE
RESPONSES THAT WE GET IN THE
FIELD OF CANCER IMMUNOTHERAPY IS
INCREDIBLY RELEVANT TO THE
PROBLEM OF EVEN SOMETHING WE
DIDN'T THINK OF AS BEING
SOMETHING THAT WAS JOINED TO
CANCER, IT'S A VERY EXCITING
TIME.
LET'S SEE.
LUCILA?
THANK YOU.
>> YES, THANK YOU.
I'M ALSO A ROOKIE ON THIS
COMMITTEE, VERY HONORED TO BE
HERE.
I'M EXCITED ABOUT THIS INVOLVING
EVERYONE INTO THE NATIONAL
CANCER PLAN.
MY QUESTION IS, WITH REGARDS TO
WORK ALSO WITH OTHER AGENCIES IN
TERMS OF HEALTH LITERACY, IN
TERMS OF RESEARCH, ARE YOU
THINKING OF SOMETHING FOR THE
K-12, FOR EXAMPLE, OR COMMUNITY
COLLEGES, IN ALL THIS EDUCATION
THAT NEEDS TO EXIST?
>>YEAH, SO OF COURSE HEALTH
LITERACY IS ABSOLUTELY KEY TO
EVERYTHING.
YOU'VE ALREADY HEARD A GREAT
NIH-WIDE PROGRAM TARGETING
HEALTH LITERACY, TRUE FOR AWFUL
US.
THE ASKED A QUESTION ABOUT THE
MOONSHOT AND PRESIDENT'S
APPROACH.
THE DEPARTMENT OF EDUCATION SITS
ON THE PRESIDENT'S CANCER PANEL,
THIS IS A QUESTION THAT'S BEEN
DISCUSSED WITH THEM, WHAT CAN
EDUCATION HAVE TO CONTRIBUTE TO
LET LITERACY AS WELL.
IF THE FOCUS FOR THAT
PRESIDENT'S CANCER PANEL IS ON
CANCER, WE CAN ALSO USE THAT
VEHICLE TO PROMOTE HEALTH FOR
ALL.
YOU SAY GOING RIGHT DOWN TO
PRESCHOOL.
WE ALL KNOW THAT'S ESSENTIAL IF
WE'RE GOING TO MAKE PROGRESS.
>> THANK YOU.
>> ATUL?
>> ALL RIGHT.
>> THANK YOU FOR THE
PRESENTATION.
I'M A HUGE FAN OF YOUR WORK.
I'M REALLY ENCOURAGED TO SEE YOU
IN THE BLUE RIBBON PANEL
INDICATING FOR SUPPORT FOR
PATIENTS, DIRECT PATIENT
INVOLVEMENT.
IT'S A LONG QUESTION BUT I'M
GOING TO POKE AND PROD HERE.
I LOVE THE DATA SHARING GOALS
YOU SHOWED BUT PARTICULARLY
FOCUSED ON MOLECULAR AND
CELLULAR DATA, NOT MUCH ON
CLINICAL DATA, WHAT I'LL
CHALLENGE YOU ON BY TAKING A
MOMENT TO SHOWCASE SOMETHING I
THINK NIH DID REALLY WELL DURING
THE COVID PANDEMIC.
AND NCI COULD THINK ABOUT.
DURING COVID, NCATS IN
PARTICULAR BUILT THIS NATIONAL
COVID COHORT COLLABORATIVE, N3C,
WORKING THROUGH CTSAs, 102
CLINICAL SITES, CENTRALIZED
DATABASE, 19.1 MILLION PATIENTS,
400 RESEARCH PROJECTS, SECURELY
LINKED TO CMS, SOCIAL
DETERMINANTS OF HEALTH.
I'M NOT SAYING EVERYTHING WAS
DONE PERFECTLY OR IN
NON-CONTROVERSIAL WAY.
EVEN OTHERS ON ACD HAVE ISSUES
WITH THAT BUT IT DID WORK,
THERE'S SOMETHING TO BE ADMIRED
THERE.
NOW WE'RE IN A REIGNITED CANCER
MOONSHOT AGAIN AND WE STILL
DON'T HAVE AN EQUIVALENT OF N3C
FOR CANCER.
NCI DOES NOT REQUIRE NCI CANCER
CENTERS TO WORK TOGETHER AT ALL,
PARTICULARLY TO SHARE CLINICAL
DATA.
AND TO BE CLEAR, I DON'T SEE A
WAY TO SHARE CANCER CASES, CARE
OF THE PATIENT, AND THE
OUTCOMES.
IT'S ALREADY THREE YEARS OLD.
IF YOU AND I HAD A PROBLEM WITH
CANCER WE WOULD KNOW WHERE TO GO
BECAUSE OF OUR PRIVILEGE BUT THE
PUBLIC HAS NO NCI-DRIVEN TOOLS
FOR PATIENTS TO SEARCH THROUGH
NCI CANCER CENTERS TO FIND THE
BEST CANCER CENTERS.
WE HAVE A MAP, THAT'S ABOUT IT.
NO DIRECT COMPARISON TOOLS TO
COMPARE OUTCOMES, QUALITY OF
CARE, WE LEAVE THOSE TASKS TO
U.
"U.S. NEWS & WORLD REPORT" OR
ORGANIZATIONS OR GOOGLE SO A
PATIENT TYPES IN THE NAME OF THE
CANCER AND WHOEVER BUYS THE ADS
AT THE TOP GETS THE CLICK AND
CARE.
SO WHY NOT NCI?
WHY CAN'T NCI DIRECTLY FUND
PATIENT CENTRIC TOOLS TO
UNDERSTAND WHAT SHOULD HAPPEN
NEXT WITH THAT DIAGNOSIS AND
WHERE THEY SHOULD GET THEIR
CARE, LET ME STOP THERE.
>> DID WE PLANT YOU ON THIS
COMMITTEE?
YOU'RE SPEAKING AS YOU KNOW,
ATUL, IN SOMETHING THAT -- A
TOPIC I'M MOST COMMITTED TO
ABOVE ALL ELSE, RIGHT?
HERE'S WHAT I'LL DO.
THIS COULD BE A THREE-HOUR
CONVERSATION.
TAKE A LOOK AT CC DIRECT, TAKE A
LOOK AT THIS PUBLIC/PRIVATE
PARTNERSHIP AT WHAT C.C. DIRECT
IS DOING.
THIS IS NCI'S PILOT.
THERE ARE 13,000 CHILDREN
DIAGNOSED WITH CANCER EVERY
YEAR.
IT IS A DIRECTED, DEFINED
POPULATION THAT WE CAN REALLY
FOCUS ON BUT C.C. DIRECT IS
BUILDING TOOLS THAT WILL SCALE
TO THE ENTIRE POPULATION, WHAT
ARE THE TOOLS?
NUMBER ONE, A STANDARDIZED
COMPUTABLE SHAREABLE CLINICAL
RECORD THAT IS COMING FROM EVERY
CLINICAL SITE ACROSS THE WHOLE
UNITED STATES.
NUMBER TWO, A CONSENT, A
COMPUTABLE CONSENT, WE'RE NOT
GOING TO BE USING DATA FOR
RESEARCH WHERE THESE CHILDREN OR
FAMILIES ARE NOT GIVING US
PERMISSION AND YOU KNOW THAT
TECHNOLOGY EXISTS TO PUT A NICE
METADATA TAG ON EVERY PIECE OF
DATA THAT SAYS YES THIS PATIENT
IS CONSENTED OR NO THIS PATIENT
SAID NO.
SO WE CAN FINALLY HONOR ON A
NATIONAL SCALE PEOPLE'S DESIRES
FOR WHETHER WE USE THEIR DATA OR
NOT BECAUSE I THINK WE GOT TO
LISTEN TO PEOPLE NO MATTER WHAT.
OTHERWISE WHY WOULD THEY TRUST
US, RIGHT?
THAT'S NUMBER TWO.
NUMBER THREE, IT IS TIED TO
NAVIGATION.
WE MAKE SURE THESE KIDS, AND WE
DO WELL WITH KIDS IN AMERICA,
MOST KIDS GET IN, BUT THERE'S
STILL 10 TO 15% THAT DON'T, THEY
ARE SOMEWHERE, SO IT'S ALL
THROUGH A WEBSITE.
TAKE A LOOK.
THIS IS WHAT WE WANT TO DO AND
SCALE.
>> WE'LL CHAT A LOT.
>> THIS IS AN ALL-OF-GOVERNMENT
APPROACH.
YOU'LL SEE THE OTHER GOVERNMENT
AGENCIES BY OUR SIDE HELPING TO
DO THIS.
>> THANKS.
>> SHELLEY, YOU'RE NEXT.
>> WONDERFUL SUMMARY OF THE
WORK THAT'S BEING DONE UNDER THE
CANCER MOONSHOT.
I WONDERED, I LOVED THE EXAMPLES
OF THE BASIC RESEARCH
INITIATIVES, THREE EXAMPLES,
REALLY EXCITING.
I WONDERED IS THAT THE MAIN --
ARE THOSE THE MAIN INITIATIVES
GOING FORWARD INTO THE NEXT
ITERATION, ARE THERE GOING TO BE
ADDITIONAL ONES?
YOU DIDN'T REALLY SPEAK TO THAT
IN YOUR LATER REMARKS.
>> THANK YOU.
THE REASON I HIGHLIGHTED THOSE,
I WANTED TO HIGHLIGHT THE ONES
AVAILABLE TO THE COMMUNITY FOR
SHARING AND USE.
I WANTED TO MAKE IT VERY CLEAR
WHICH ONES THESE MOONSHOT WORK
IS ABOUT, BUILDING COMMUNITY AND
BUILDING RESOURCES, AND SETTING
IT OUT THERE FOR EVERY 2010
PARTICIPATE, WHICH IS WHY I
PICKED THESE.
YEAH, WE CAN'T LET THESE SUNSET.
WE'RE GOING HAVE TO FIND A WAY
TO KEEP THIS GOING.
AS YOU KNOW, THAT MIGHT BE TOUGH
BUT THANK GOODNESS THE PRESIDENT
IS SUPPORTING AT LEAST HIS
BUDGET, SUPPORTING WHAT WE NEED
TO DO TO KEEP THOSE GOING.
THERE WILL BE NEW THINGS.
THERE'S ALWAYS NEW THINGS.
AGAIN, AS WE LEARN AND CONTINUE
TO RESPOND TO THE NEEDS OF OUR
RESEARCH AND PATIENT COMMUNITY,
BUT THESE ARE THE CORE
RESOURCES.
FINALLY IMMUNOTHERAPY STUDIES
WERE TARGETED TO IMMUNOTHERAPY.
THESE THINGS CAN BE SCALED ONCE
YOU HAVE THESE MODELS.
I WILL SAY THAT'S OUR GENERAL
APPROACH.
MODEL AND SCALE, MODEL AND
SCALE.
THAT'S HOW WE GET THE
COLLABORATION WE NEED.
>> THANK YOU.
ABSOLUTELY WONDERFUL
INITIATIVES.
I APPLAUD.
>> AMAZING COLLEAGUES AT NCI
AND BEYOND.
THEY GET ALL THE CREDIT.
YES, GARTH?
>> THANK YOU FOR THAT
PRESENTATION.
A SIMPLE QUESTION.
THE MOONSHOT SCHOLARS PROGRAM,
IS THAT DIRECTLY TARGETED FOR
UNDERREPRESENTED MINORITY GROUPS
OR IS IT A BROADER PROGRAM THAT
HAS ONE OF THE FOCI BEING
UNDERREPRESENTED MINORITIES
GROUPS AND DO YOU KNOW HOW IT'S
GOING IN TERMS OF BEING ABLE TO
GET R01-FUNDED INVESTIGATORS
FROM UNDERREPRESENTED GROUPS
GIVEN THE MACROCHALLENGES, EVEN
UNRELATED TO THIS PROGRAM?
>> IT'S DIRECTLY TARGETED
TOWARD UNDERREPRESENTED MINORITY
GROUPS.
WE'RE JUST NOW RECEIVING THE
FIRST ROUND OF APPLICANTS.
WHAT I CAN TELL YOU IS THAT IT'S
BEEN WONDERFUL TO SEE NOT ONLY
THE DIVERSITY OF RESEARCHERS BUT
DIVERSITY OF PROJECTS.
IT'S EVERYTHING FROM BASIC
SCIENCE TO COMPUTATIONAL BIOLOGY
TO CANCER CARE DELIVERY
RESEARCH.
IT'S A REALLY GREAT SPECTRUM.
AS THE PROGRAM IS BEING
CENTRALLY MANAGED, AS
APPLICATIONS COME IN THEIR BEING
HANDLED BY THE VARIOUS EXPERT
GROUPS WITHIN NCI WHO EVALUATE
AND LOOK AT THESE PROGRAMS AND
THE IDEA IS THESE INDIVIDUALS
WOULD THEN BE HOPEFULLY -- WE
WANT TO SEE THEM SUCCEED AND BE
EMBRACED BY THE VARIOUS
SUBCOMPONENTS OF 1999 -- OF NC.
COREY?
>> IN TERMS OF THE SPECIFIC
DIVERSITY, IN TERMS OF
ACKNOWLEDGMENT FOR NEED FOR MY
DIVERSITY AMONG CANCER
RESEARCHERS, INITIATIVES
FOCUSING ON UNDERREPRESENTED
RESEARCHERS, MY QUESTION ABOUT
HISTORICALLY BLACK COLLEGES AND
UNIVERSITIES BE TARGETED AS A
STRATEGY FOR ENHANCING TEAM OF
QUALIFIED APPLICANTS FOR
PARTICIPATING IN THAT PROGRAM?
YOU INDICATED THAT THE FOCUS IS
ON IDENTIFYING EARLY CAREER
INVESTIGATORS, AND SO I THINK IT
WOULD BE IMPORTANT TO IDENTIFY
HBCUS AND OTHER MINORITY-SERVING
INSTITUTIONS BECAUSE NUMBERS OF
INDIVIDUALS FROM MINORITY
BACKGROUNDS OR SCHOLARS AND
FACULTY MEMBERS AND INDIVIDUALS
WITH DISABILITIES AS WELL,
RACIAL AND ETHNIC GROUPS, AGAIN
MY QUESTION ARE THERE PLANS FOR
TARGETING HBCUs AND
MINORITY-SERVING INSTITUTIONS
ENROLLING A NUMBER OF AVAILABLE
CANCER RESEARCHERS FOR FUTURE
RESEARCH.
>> SO, TWO THINGS.
FIRST OF ALL, THERE ARE PLANS,
NCI HAS HAD THIS AS A MAJOR
FOCUS FOR MORE THAN A DECADE.
I REFER YOU TO THE CENTER FOR
REDUCING CANCER HEALTH
DISPARITIES, WHICH IS A CENTER
WITHIN NCI, THAT CENTER
COORDINATES PROGRAMS TO
FACILITATE TRAINING AND ACCESS
AND CAREER SUPPORT ACROSS THAT
SPECTRUM OF WHAT WE NEED TO
ACHIEVE DIVERSITY IN OUR CANCER
RESEARCH INVESTIGATORS.
IT ALSO -- IT'S HELPING
COORDINATE CANCER MOONSHOT
SCHOLARS BUT THE ENTIRE CENTER
WITHIN NCI HAS BEEN AROUND FOR
MORE THAN A DECADE NOW THAT DOES
THIS WORK.
I'LL ALSO SAY THROUGHOUT EVERY
DIVISION OF NCI THERE ARE ALSO
PROGRAM OFFICERS WHO ARE WORKING
WITH CRCHC DEVOTE THE TO THIS
ISSUE.
IT PERMEATES THROUGH NCI AND
FOCUS ON AREAS TO YIELD SUCCESS
BECAUSE WE'RE PARTNERING, LIKE
YOU SAY, PARTNERING WITH THE
COLLEGES AND UNIVERSITIES AND
CENTERS THAT CAN HELP US SUCCEED
IN THIS IS THE GOAL.
FINALLY EIGHT GOALS OF THE
NATIONAL CANCER PLAN, ONE GOAL,
ELIMINATE INEQUITIES.
IF YOU LOOK UNDER THE SUBAIMS OF
THOSE GOALS, IT'S NOT ONLY
ELIMINATE INEQUITIES FOR THE
PEOPLE WE SERVE IN THE UNITED
STATES AND WORLD, ELIMINATE
INEQUITIES WE HAVE IN OUR --
THROUGHOUT EVERY ONE OF THE
OTHER GOALS, IN RESEARCH, IN
CARE DELIVERY, IN EVERYTHING
THAT WE DO.
>> QUICK FOLLOW-UP.
IN TERMS OF UNDERREPRESENTED
RESEARCHERS, SO WE UNDERSTAND
ETHNIC MINORITIES, INDIVIDUALS
IN THOSE POPULATIONS CLEARLY
REPRESENT RESEARCHERS WHO DON'T
ALWAYS -- AS EARLY CAREER
INVESTIGATORS DON'T ALWAYS HAVE
THE OPPORTUNITY TO RECEIVE
MENTORSHIP, NET WORK
OPPORTUNITIES, LACK OF GROWTH AS
RESEARCHERS THAT ONE GROUP THAT
IS SOMETIMES LEFT OUT OF THE
DISCUSSION IS RESEARCHERS WITH
DISABILITIES.
SO WHAT PLANS MIGHT YOU HAVE IN
TERMS OF DIVERSIFICATION OF THE
COUNCIL OF SCIENTIFIC WORKFORCE
TO BE INCLUSIVE INDIVIDUALS WITH
DISABILITIES INCLUDING THOSE
WITH MINORITY BACKGROUNDS.
>> NIH HACK A FOCUS ON DEIA, A
BUYING ACCESSIBILITY, LARRY
PRESENTED SOME IN THE INTRO.
ALSO ONE OF THE MAJOR WORKING
GROUPS OF THE NCI EQUITY COUNCIL
IN COLLABORATION WITH CENTER FOR
REDUCING HEALTH DISPARITIES IS
ALL ABOUT INDIVIDUALS WITH
DISABILITIES, AND ALL THE
APPROACHES WE NEED TO BE ABLE TO
REALIZE THEIR POTENTIAL FOR
CONTRIBUTING TO THE SUCCESS OF
NCI.
THESE ARE CHALLENGES.
AND WE'RE VERY, VERY COMMITTED
TO THEM AND, AGAIN, NEED MORE
PARTNERS TO DO MORE BUT THERE'S
MANY WILLING PEOPLE AT NIH AND
NCI ALREADY TRYING TO MEET THE
CHALLENGE.
>> IF I COULD JUMP IN.
I WANT TO SAY IF YOU HAVE A
CHANCE AT SOME POINT, DR. MOORE,
REVIEW THE DEIA PLAN THAT I
ALLUDED TO EARLIER, YOU WILL SEE
THAT WE ARE DOING MUCH MORE
CONCERTED EFFORT TO REACH OUT TO
THOSE INDIVIDUALS IN THE
DISABILITY COMMUNITY, AND AGAIN
WE'LL LOOK FORWARD TO YOUR
GUIDANCE, THIS IS AN AREA YOU'VE
THOUGHT ABOUT A GREAT DEAL, AS
WE INCREASE OUR EFFORT TO ENGAGE
WITH THOSE GROUPS.
SO REALLY APPRECIATE YOUR
COMMENT.
TARA, WE'RE GETTING CLOSE TO THE
WITCHING HOUR.
>> I'VE BEEN HAVING AUDIO
ISSUES.
I'M NOT SURE IF PEOPLE CAN HEAR
ME NOW.
I HAVE A COMMENT.
GOOD, THUMBS UP.
THAT'S GREAT.
I WOULD POINT OUT MARIE BERNARD
IS GOING TO GIVE AN UPDATE ON
SOME ACCESSIBILITY WORK THAT WE
HAVE ONGOING ACROSS NIH TOMORROW
MORNING.
SO THAT'S SOMETHING THAT MAKE
SURE TO LOOK OUT FOR.
HOWARD, WE'RE AT TIME, WE'LL
HAVE YOU BE THE FINAL WORD FOR
THIS SESSION AND GIVE FOLKS A
BREAK.
>> I'LL KEEP IT SHORT.
THAT WAS A GREAT PRESENTATION TO
SEE THE PROGRESS.
MY QUESTION IS ABOUT LESSONS
FROM CANCER MOONSHOT, IN A MIGHT
APPLY TO THE R01 ESPECIALLY
BECAUSE YOU TALK ABOUT TEAMS,
PARTNERSHIP, COLLABORATION, BUT
THE METRICS FOR EVALUATION FOR
YOUR I GUESS BREAD AND BUTTER IS
REALLY ABOUT INDIVIDUAL LAB
ACHIEVEMENT.
HOW CAN WE CHANGE THAT CULTURE,
MAYBE EVALUATION METRIC, TO GET
PEOPLE TO WORK TOGETHER MORE?
>> WELL, I'LL CHALLENGE YOU A
BIT JUST BY SAYING THAT THE R01
MECHANISM HAS PRODUCED AMAZING
SUCCESS FOR US.
SO LET'S START BY SAYING WE'VE
GOT A TREMENDOUSLY SUCCESSFUL
PROGRAM THAT WE, AND ONE WHERE
LITERALLY ANY RESEARCHER WITH A
GREAT IDEA CAN COMPETE FOR THIS
FUNDING.
THAT'S INCREDIBLY VALUABLE.
AS YOU KNOW THERE ARE OTHER
MECHANISMS TRULY BASED ON
COLLABORATION, THEY ARE ALL
THROUGHOUT NIH.
SO, MY ANSWER IS WE NEED BOTH.
WE CAN FACILITATE COLLABORATION
BY RESOURCES AND INCENTIVES, AND
PROJECTS SUCH AS THE ONES I'VE
PROPOSED TO YOU, BUT RATHER THAN
TRYING TO, I DON'T KNOW, PLACE
RESTRICTIONS ON WHAT PEOPLE CAN
AND DO APPLY FOR, I'D RATHER
GIVE PEOPLE ALL THE OPTIONS
AVAILABLE AND MAKE THE
COLLABORATION OPTIONS REALLY,
REALLY ATTRACTIVE.
LIKE I SAID WE DON'T WANT TO
MESS WITH SUCCESS EITHER.
THERE ARE MANY SUCCESSES THAT
HAVE COME OUT OF THAT EXISTING
R01 MECHANISM.
SO LET'S DO BOTH.
THAT'S MY IDEA.
I WILL SAY FINALLY THAT ONE
THING WE REALLY WOULD LIKE, THAT
I TRY TO ADVOCATE WHEN I
POSSIBLY CAN IS RECOGNITION ON
THE PARTS OF OUR ACADEMIC
INSTITUTIONS FOR TEAM SCIENCE.
THAT I DO THINK WE NEED TO TRY
TO CONTINUE TO DO MORE ON.
>> THANK YOU.
I PROMISE AFTER THE BREAK I
HOPEFULLY WILL HAVE BETTER AUDIO
BECAUSE I KEEP GETTING -- IT'S
NOT WORKING WELL.
TO REALLY APPRECIATE YOU,
MONICA, FOR THE TIME AND
PRESENTING ON THIS IMPORTANT
INITIATIVE TO THE GROUP.
WITH THAT WE'LL ADJOURN FOR A
BREAK, AND IF WE COULD MAKE SURE
EVERYONE IS BACK AT 1:45, WE'D
APPRECIATE THAT TO MAKE SURE
WE'LL HIT QUORUM.
WE'LL SEE EVERYONE BACK AT 1:45.
>> WELCOME BACK, EVERYONE.
WE'LL WELCOME THOSE STILL
GETTING SITUATED AND TURNING ON
CAMERAS.
WE WANT TO SHIFT INTO THE NEXT
SESSION, WHERE WE'LL WELCOME DR.
SHELLI AVENEVOLI, DEPUTY
DIRECTOR OF THE NATIONAL
INSTITUTE OF MENTAL HEALTH, AND
SHE'S GOING TO TALK A LITTLE BIT
ABOUT SOME REALLY IMPORTANT WORK
THEY ARE DOING TO ADDRESS THE
MENTAL HEALTH CRISIS THROUGH
RESEARCH.
>> THANKS, TARA.
GOOD AFTERNOON.
I'M PLEASED TO BE HERE TODAY.
IT'S AN HONOR TO SPEAK WITH YOU
AND UPDATE WHAT WE KNOW ABOUT
THE MENTAL HEALTH CRISIS AND
WHAT WE ARE DOING THROUGH
RESEARCH TO ADDRESS IT.
I THINK WE'RE WAITING ON THE
SLIDES.
YOU CAN GO TO THE NEXT SLIDE
PLEASE.
I WANTED TO DIVIDE THE
PRESENTATION INTO THREE PARTS.
FIRST WHAT WE'VE LEARNED THROUGH
RESEARCH ON HOW THE COVID-19
PANDEMIC HAS ACTUALLY
EXACERBATED THE MENTAL HEALTH
CRISIS, I THEN WANT TO ZERO IN
ON THE CRISIS AMONG YOUTH
SPECIFICALLY, AND TELL YOU ABOUT
SOME OF THE INITIATIVES WE ARE
SUPPORTING TO MEET THE MOMENT IN
MENTAL HEALTH.
NEXT SLIDE PLEASE.
I LIKE TO START WITH THE NIMH
MISSION, TO TRANSFORM THE
UNDERSTANDING AND TREATMENT OF
MENTAL ILLNESS, PAVING THE WAY
FOR PREVENTION AND CURE.
NEXT SLIDE.
I WANTED TO TAKE THIS BRIEF
MOMENT TO PROVIDE YOU CAN
EVIDENCE THAT WE ARE IN THE
MIDST OF A MENTAL HEALTH CRISIS,
MENTAL DISORDERS ARE HIGHLY
PREVALENT, BURDENSOME, AND CARE
IS NOT ALWAYS AVAILABLE FOR
THOSE WHO NEED IT.
ABOUT HALF OF ALL AMERICAN
ADULTS AND ADOLESCENTS HAVE
REPORTED A PSYCHIATRIC DISORDER
IN THEIR LIFETIME.
MENTAL AND SUBSTANCE USE
DISORDERS ARE ALSO THE THIRD
LEADING CAUSE OF DISABILITY IN
THE UNITED STATES RIGHT NOW, AND
AS YOU CAN SEE FROM THIS FIGURE
HERE, WHAT IS PARTICULARLY
CONCERNING IS THAT THE BURDEN OF
MENTAL AND SUBSTANCE USE
DISORDERS, THE BLUE LINE, STARTS
VERY EARLY IN LIFE, AND THIS
MEANS MANY INDIVIDUALS WILL
CARRY THIS BURDEN THROUGHOUT
MUCH OF THEIR LIFETIME.
NEXT SLIDE.
LET'S SHIFT THE CONVERSATION TO
THE COVID-19 PANDEMIC.
NEXT SLIDE PLEASE.
EARLY IN THE PANDEMIC THERE WAS
ALREADY EVIDENCE OF A
SUBSTANTIAL INCREASE IN
SELF-REPORTED SYMPTOMS OF
DISSTRESS, IN JUNE OF 2020 THE
CDC REPORTED THAT 40% OF U.S.
ADULTS REPORTED STRUGGLING WITH
MENTAL HEALTH OR SUBSTANCE
ABUSE, 31% REPORTED SYMPTOMS OF
ANXIETY OR DEPRESSION, 11%
REPORTED SUICIDAL IDEATION,
WHAT'S IMPORTANT TO CONSIDER
HERE IS THAT THESE NUMBERS ARE
NEARLY DOUBLE WHAT WOULD BE
EXPECTED BEFORE THE PANDEMIC
BEGAN.
THE RATES ARE SIMILAR FOR
CHILDREN AND ADOLESCENCE,
ESSENTIALLY DOUBLE PRE-PANDEMIC
ESTIMATES AS WELL.
SURVEYS SHOW RATES OF SYMPTOMS
CONTINUE TO INCREASE AND REMAIN
STABLE THROUGHOUT.
IT ALSO BECAME EVIDENT THE
PANDEMIC WAS HAVING
DISPROPORTIONATE IMPACT ON
INDIVIDUALS FROM SOME RACIAL AND
ETHNIC GROUPS, PARTICULARLY
BLACK AND HISPANIC INDIVIDUALS,
AS WELL AS ON FRONT LINE
WORKERS, MIGRANTS, LOW INCOME
LEVELS, WITH PREEXISTING
PSYCHIATRIC OR MENTAL HEALTH
CONDITIONS, JUST TO NAME A FEW.
NEXT SLIDE PLEASE.
NEXT QUESTION IS GIVEN WHERE WE
ARE WITH PUBLIC HEALTH EMERGENCY
HAVING ENDED, WHAT WILL BE THE
LONG-TERM IMPACT OF THE PANDEMIC
ON MELT?
WE DON'T HAVE THOSE ANSWERS YET
BUT HAVE STARTED TO SEE
FLUCTUATIONS AND SYMPTOMS OVER
THE COURSE OF THE PANDEMIC.
ON LEFT RATES OF ANXIETY AND
DEPRESSION, DOTTED LINES,
FLUCTUATED AS NUMBER OF THE
COVID CASES OR VACCINE RATES
HAVE RISEN AND FALLEN.
AND THE COVID CASES IN THE RED
LINE.
WE CAN ALSO LEARN A LOT FROM
PRIOR RESEARCH ON EXPOSURE TO
OTHER SIGNIFICANT EVENTS LIKE
NATURAL DISASTERS.
THAT RESEARCH HAS TOLD US THAT
THESE EVENTS DO LEAD TO
INCREASED INITIAL SYMPTOMS AMONG
A LARGE MAJORITY OF THE
POPULATION, BUT THE IDEA THESE
GENERALLY IMPROVE WITH TIME.
HOWEVER, THERE WILL BE OR WE
EXPECT A MINORITY OF INDIVIDUALS
WITH LONG-TERM OR CHRONIC
EXPERIENCE WITH MENTAL ILLNESS,
IT'S BEEN THE CASE WITH PRIOR
EVENTS THESE TEND TO EXPLOIT
SYSTEMIC AND SOCIAL INEQUITIES
THAT EXISTED LONG BEFORE THE
EVENTS.
NEXT SLIDE.
ONE OF THE MOST COMMON QUESTIONS
WE GET IS WHAT PUTS SOME PEOPLE
AT GREATER RISK FOR MENTAL
PROBLEMS THAN OTHERS?
THIS SLIDE REPRESENTS A HOST OF
POSSIBILITIES, THINGS LIKE
EXPOSURE TO THE DEATH OR INJURY
OF A LOVED ONE DURING THE
PANDEMIC, HISTORY OF TRAUMA OR
MENTAL ILLNESS, BEING FEMALE,
NON-WHITE, HAVING FEW SOCIAL
SUPPORTS, LIVING IN AREAS WITH
SEVERE OUTBREAKS, SOME OF THE
PANDEMIC SPECIFIC FACTORS,
DISRUPTION IN ROUTINES, AND
EXPERIENCES WITH ADVERSE
CHILDHOOD EXPERIENCES JUST TO
NAME A FEW.
NEXT SLIDE.
I'VE MENTIONED THAT THERE ARE
DISPARITIES IN MENTAL OUTCOMES,
WHAT ARE SOME FACTORS THAT MIGHT
EXPLAIN THESE DISPARITIES?
YOU SEE AN EXAMPLE OF ONE STUDY
ON ADOLESCENTS ADAPTED FROM
BRAIN AND CHILD DEVELOPMENT
STUDY, IN THAT GROUP THEY FOUND
THAT SEVERAL SOCIAL DETERMINANTS
OF HEALTH, PANDEMIC-RELATED FOOD
INSECURITY, PARENTAL
UNEMPLOYMENT, DISRUPTED MENTAL
TREATMENT AND LAGGING
VACCINATION RATES WERE
ASSOCIATED WITH NEGATIVE
OUTCOMES BUT THESE ASSOCIATIONS
WERE MORE COMMON AMONG ASIAN,
BLACK, HISPANIC CHILDREN THAN
AMONG WHITE CHILDREN.
ANOTHER DISPARITY ARE PEOPLE
WITH MENTAL ILLNESS, INCREASED
FOR INFECTION WITH SARS-COV-2
AND ALSO INCREASED RISK OF DEATH
FROM INFECTION WITH COVID-19.
ANOTHER LINE OF RESEARCH WE
FUNDED LOOKED AT WAYS WE MIGHT
MITIGATE THE IMPACT OF PANDEMIC
STRESSORS ON MENTAL HEALTH
OUTCOMES.
THIS STUDY SHOWS HERE THAT
ACCESS TO FREE GROCERIES OR
MEALS IMPROVED MENTAL HEALTH,
THAT MAY NOT BE SURPRISING BUT
WE KNOW FROM PRIOR RESEARCH THAT
INTERVENTIONS THAT FIRST ADDRESS
THE MOST PRESSING ECONOMIC OR
SOCIAL NEEDS LIKE FOOD
INSECURITY LOWER RISK AND
MAXIMIZE CHANCE FOR RECOVERY.
ALSO PROMOTING HEALTHY COPING
STRATEGIES AND TREATING NEW OR
WORSENING ILLNESSES AS SOON AS
POSSIBLE.
I WANT TO ACKNOWLEDGE THOSE WITH
MENTAL ILLNESS EXPERIENCE
SIGNIFICANT DISRUPTIONS IN CARE
DURING THE PANDEMIC, WE SAW
NOTABLE DECREASES IN THINGS LIKE
OUTPATIENT VISITS PRESCRIPTION
REFILLS, HOSPITAL ADMISSIONS.
NEXT SLIDE.
RATES OF TELEHEALTH INCREASED,
60 TO 80% AND REMAINED STABLE.
THE GOOD NEWS IS THAT THIS
ALLOWED MANY INDIVIDUALS TO GET
THE CARE THEY NEEDED, BROUGHT
NEW PEOPLE TO CARE DURING THE
PANDEMIC.
HOWEVER, UNFORTUNATELY, THERE
ARE DISPARITIES IN THE ACCESS
AND USAGE OF TELEHEALTH, WITH
SIGNIFICANTLY LOWER USAGE BY
BLACK AMERICANS, HISPANICS,
ASIAN AMERICANS.
THIS HAS BEEN INCONSISTENT SO
THERE'S RESEARCH UNDERWAY TO
BETTER UNDERSTAND USE OF
TELEHEALTH.
NEXT SLIDE PLEASE.
I WANTED TO TAKE A MOMENT TO
HIGHLIGHT SOME OF THE AREAS OF
FOCI OF RESEARCH WE SUPPORTED
THROUGH THE PANDEMIC.
IN THE BEGINNING WE DID MORE
GENERAL ANNOUNCEMENTS CALLING
FOR BASIC TRANSLATIONAL
INTERVENTIONS AND SERVICES
RESEARCH FOCUSED ON THE IMPACT
OF THE PANDEMIC ON MENTAL
HEALTH.
BUT WE PLACED SPECIAL EMPHASIS
ON RESEARCH THAT INFORMS HOW TO
MITIGATE IMPACT ON THE PANDEMIC.
WE KNEW THE PANDEMIC HAD
NEGATIVE EFFECTS BUT DON'T KNOW
HOW BEST TO MITIGATE.
WE PUT STRONG EMPHASIS ON
UNDERSTANDING THE IMPACT OF THE
PANDEMIC AND UNDERSERVE AND
VULNERABLE POPULATIONS, TO
IDENTIFY AND ADDRESS THESE
HEALTH DISPARITIES, AND THIS IS
SOMETHING WE DID IN
COLLABORATION WITH MANY OF OUR
SISTER INSTITUTES AND CENTERS AT
NIH.
WE ADDRESSED INITIATIVES LIKE
SCHOOL DISRUPTION AND VACCINE
HESITANCY.
THIS LAST SLIDE SUMMARIZES MUCH
OF WHAT I'VE TOLD YOU ALREADY,
THAT THERE'S BEEN AN INCREASE IN
SYMPTOMS WE HOPE THAT WILL
DECLINE, THERE IS A
BIDIRECTIONAL RELATIONSHIP
LEADING YOU VULNERABLE, WITH A
NEGATIVE IMPACT ON MENTAL
HEALTH, THE PANDEMIC HAS
EXPLOITED INEQUITIES AND STILL
RESEARCH WE'RE WAITING TO INFORM
OUR FUTURE EFFORTS.
NEXT SLIDE.
SWITCHING GEARS, LARRY ALLUDED
TO IN HIS INTRODUCTION THAT THE
U.S. SURGEON GENERAL RELEASED AN
ADVISORY IN LATE 2021, THAT
HIGHLIGHTED THAT WE ARE IN THE
MIDST OF A YOUTH MENTAL HEALTH
CRISIS.
THE NEEDS OF CHILDREN AND
ADOLESCENTS WERE ON THE RISE
LONG BEFORE THE PANDEMIC AND
I'LL TELL YOU ABOUT THAT NOW.
NEXT SLIDE.
ONE OF THE DEFINING
CHARACTERISTICS IS HOW COMMON
MENTAL HEALTH PROBLEMS ACTUALLY
ARE, I MENTIONED THAT ABOUT 50%
REPORT LIFETIME MENTAL DISORDERS
OF ANY KIND, 22% REPORT SEVERE
DISORDERS, IN 2021 ABOUT 20% OR
FIVE MILLION HAD A MAJOR
DEPRESSIVE EPISODE IN THE PAST
YEAR ALONE.
NEXT SLIDE PLEASE.
ANOTHER DEFINE CHARACTERISTIC IS
INCREASE IN MENTAL HEALTH
PROBLEMS OVER THE PAST TWO
DECADES.
SURVEYS SHOW INCREASES IN
DEPRESSIVE SYMPTOMS, SUICIDAL
IDEATION, FEELINGS EVER SADNESS
AND HOPELESSNESS, 40% REPORTING
SYMPTOMS AT A GIVEN TIME.
THIS FIGURE SHOWS THAT RATES OF
MAJOR DEPRESSIVE EPISODES
INCREASED FROM 2004 TO 2020, AND
VISITS TO EMERGENCY DEPARTMENTS
INCREASED DURING THIS PERIOD.
WE'VE SEEN INCREASING RATES OF
SUICIDE, INCREASING BY 57%, THEY
DID TAKE A DIP BETWEEN 2018 AND
2020, BUT UNFORTUNATELY THEY
INCREASED AGAIN IN 2021 ALMOST
TO THE 2018 LEVELS.
YOU CAN SEE DIFFERENCES BY RACE.
I WANT TO HIGHLIGHT THE TOP RED
LINE, THE SUICIDE RATES AMONG
AMERICAN INDIAN AND ALASKA
NATIVE ADOLESCENTS 10-24,
HIGHEST RATES IN THE UNITED
STATES.
I WANT TO DRAW YOUR ATTENTION TO
THE STARK INCREASE IN SUICIDE
RATES AMONG BLACK YOUTH,
REPRESENTED BY THE PURPLE LINE
WITH TRIANGLES.
35% OVER THE SHORT PERIOD OF
TIME.
RATES OF SUICIDE AMONG BLACK
YOUTH HAVE RISEN FASTER THAN IN
ANY OTHER RACIAL/ETHNIC GROUP IN
THE PAST TWO DECADES.
THE RATES INCREASED IN MALE AND
FEMALE BLACK ADOLESCENTS BUT
RATES IN BLACK MALE ADOLESCENTS
HAVE INCREASED BY ALMOST 60%.
ANOTHER GROUP WE'RE SEEING
INCREASES IN SUICIDE DEATHS ARE
AMONG 5 TO 9 YEARS OLD,
PRE-TEENS.
THEY HAVE INCREASED
SUBSTANTIALLY IN THE PAST FEW
YEARS, FOR THE FIRST TIME
SUICIDE IS THE TENTH LEADING
CAUSE OF DEATH IN THIS YOUNG AGE
GROUP.
I WANT TO NOTE I DON'T HAVE
STATISTICS TO SHOW BUT SEXUAL
AND GENDER MINORITY YOUTH ARE
HIGH RISK GROUP WITH ALMOST FOUR
TIMES -- FOUR TIMES MORE LIKELY
TO ATTEMPT SUICIDE THAN
CISGENDER HETEROSEXUAL PEERS.
ANOTHER CHARACTERISTICS IS UNMET
NEAT FOR TREATMENT, ONLY HALF
RECEIVE TREATMENT OR COUNSELING.
I'M HIGHLIGHTING EVEN AMONG
YOUTH WHO DO RECEIVE TREATMENT
THERE ARE DISPARITIES IN THE
TIMES OF TREATMENT THEY RECEIVE.
AND IN THE CASE OF THIS STUDY,
WHITE ADOLESCENTS MORE OFTEN
RECEIVED MENTAL HEALTH SERVICE
WHERE IS WE EXPECTED HIGHER
QUALITY OF CARE AND BLACK
ADOLESCENTS MORE OFTEN RECEIVED
CARE IN NON-SPECIALTY
FACILITIES, ASIAN ADOLESCENTS
HAD LOWEST ESTIMATE OF MENTAL
HEALTH SERVICES IN SPECIALTY AND
NON-SPECIALTY FACILITIES.
I'VE SHARED THE COMPONENTS.
WHAT AR FACTORS THAT EXPLAIN
WHY?
YOUNG PEOPLE ARE MORE OPEN TO
DISCUSS AND REPORT CONCERNS AND
SEEK CARE.
HOWEVER, THERE'S ALSO
RECOGNITION THAT MANY ASPECTS OF
OUR CHANGING SOCIAL ENVIRONMENT
MAY PLAY A ROLE DURING A HIGHLY
FORMATIVE PERIOD OF DEVELOPMENT,
AND THIS HAS LED TO A LOT OF
INCREASED INTEREST IN FACTORS
LIKE GROWING USE OF DIGITAL
MEDIA, INCREASING ACADEMIC
PRESSURE, LIMITED ACCESS TO
MENTAL HEALTH CARE, STRESSORS
LIKE 2008 FINANCIAL CRISIS,
RACISM, GUN VIOLENCE, CLIMATE
CHANGE.
I'VE THROWN A LOT OF INFORMATION
AT YOU.
I WANT TO TALK ABOUT HOW NIMH IS
TRYING TO MEET THE MOMENT TO
RESEARCH.
I WANT TO ACKNOWLEDGE THAT I'M
ONLY ABLE TO HIGHLIGHT A
SAMPLING OF SOME RECENT
INITIATIVES, BUT HAPPY TO
ADDRESS QUESTIONS ABOUT WHETHER
WE'RE HITTING OTHER OTHERS.
I'M GOING TO TOKE FOCUS ON
OVERLAPPING WITH WHITE HOUSE AND
CONGRESSIONAL INTEREST AT THE
MOMENT.
NEXT SLIDE PLEASE.
THIS SUMMARIZES SOME OF OUR
RECENT WHITE HOUSE AND
CONGRESSIONAL INTERACTIONS
FOCUSED ON MENTAL HEALTH.
STARTING IN MARCH OF 2022,
PRESIDENT BIDEN DISCUSSED THE
MENTAL HEALTH CRISIS DURING THIS
STATE OF THE UNION AND RELEASED
UNITY AGENDA.
SUMMER OF THE SAME YEAR, THE
WHITE HOUSE DOMESTIC POLICY
COUNCIL WANTED TO INTEGRATE
RESEARCH PRIORITIES INTO THAT
UNITY AGENDA.
AND SO UPON REQUEST, NIH
SUBMITTED A LIST OF PRIORITIES
IN MENTAL HEALTH RESEARCH TO THE
WHITE HOUSE.
DURING THE SAME PERIOD, WE
RECEIVED SEVERAL CONGRESSIONAL
INQUIRIES AND A REQUEST FOR
PROFESSIONAL JUDGMENT BUDGET.
THE BUDGET WHICH WE SUBMITTED IN
WINTER OF 2023, JUST RECENTLY,
WE HIGHLIGHTED THINGS THAT WE
THOUGHT WOULD BE NEEDED TO SEE
IMPROVEMENTS IN SERIOUS MENTAL
ILLNESS IN A LIMITED TIME FRAME
AND TRIED TO BE CONSISTENT WITH
THE INFORMATION THAT WE HAD
SUPPLIED ALREADY TO THE WHITE
HOUSE.
ALSO AT THE END OF WINTER THIS
YEAR, PRESIDENT BIDEN RELEASED
THE WHITE HOUSE REPORT OF MENTAL
HEALTH RESEARCH PRIORITIES AS
WELL AS HIS FY 24 PRESIDENT'S
BUDGET.
SO NIMH CONTRIBUTED
SIGNIFICANTLY TO THIS WHITE
HOUSE REPORT ON MENTAL HEALTH
RESEARCH PRIORITIES.
THE REPORT IS MEANT TO OUTLINE
ADMINISTRATION-WIDE NEEDS AND
OPPORTUNITIES, IT'S NOT MEANT TO
BE AN EXHAUSTIVE LIST OF
RESEARCH PRIORITIES.
INSTEAD HIGHLIGHTS PRIORITIES
THAT AGENCIES CAN WORK ON
TOGETHER TO HAVE MORE IMPACT OR
THAT ARE REQUIRE AGENCIES TO
WORK TOGETHER TO HAVE IMPACT.
THERE CROSS-CUTTING THEMES LIKE
ADDRESSING INEQUITIES, ACROSS
TOPICAL THINKS, SUPPORTING
MENTAL HEALTH WORKFORCE, TOPICAL
AREAS FOCUS ON INCREASING THE
IMPACT OF OUR INTERVENTIONS,
IMPROVING TREATMENTS FOR SERIOUS
MENTAL ILLNESS, PREVENTING
SUICIDE OUTCOMES, SUPPORTING
YOUTH MENTAL HEALTH.
NEXT SLIDE.
HERE IS MORE DETAIL ON THE
PRESIDENT'S FY 24 BUDGET
REQUEST, SPECIFICALLY FOR NIMH,
HIGHLIGHTS INCREASE OF $200
MILLION AND FUNDS ARE MEANT TO
SUPPORT, IF THE FUNDS WERE TO BE
MADE ABLE, SUPPORTING BETTER
DIAGNOSTICS, IMPROVED
TREATMENTS, UNDERSTANDING MENTAL
HEALTH IMPACTS OF SOCIAL MEDIA
AND ALSO PRECISION PSYCHIATRY.
NEXT SLIDE.
SO LET ME TELL YOU ABOUT SOME OF
THE CONCEPTS WE SHARED WITH THE
WHITE HOUSE AND CONGRESS.
THOSE ARE GROUPED INTO FOUR
PRIORITY AREAS, I'LL TAKE EACH
IN TURN, FIRST IS ADVANCING
LEARNING HEALTH CARE TO IMPROVE
MENTAL HEALTH OUTCOMES.
CLINICAL EFFECTIVENESS DECLINES
AS WE TAKE EVIDENCE-BASED
INTERVENTIONS OUT OF OUR
CONTROLLED RESEARCH ENVIRONMENT
AND PUT THEM INTO REAL WORLD
TREATMENT SETTINGS.
LEARNING HEALTH CARE IS A
PROMISING APPROACH THAT
HOPEFULLY WILL HELP US MITIGATE
WHAT WE CALL THIS VOTAGE DROP
AND HELP PROMOTE CONTINUOUSLY
IMPROVING HEALTH CARE.
FOR THOSE NOT FAMILIAR, LEARNING
HEALTH CARE SYSTEMS ARE MEANT TO
SYSTEMATICALLY GATHER DATA,
CREATE EVIDENCE, AND THEN APPLY
THE MOST PROMISING EVIDENCE IN
REAL TIME TO GUIDE CARE AND
ULTIMATELY IMPROVE CARE.
THE IDEA THAT AS A RESULT OF
THIS PROCESS PATIENTS GET HIGHER
QUALITY SAFER AND MORE EFFICIENT
CARE.
NIMH IS SUPPORTING A LARGE STUDY
OF THIS KIND.
THE REASON, A LITTLE BACKGROUND
WHY WE'RE FOCUSED ON EARLY
PSYCHOSIS, IT'S BECAUSE THE
NUMBER OF CLINICAL PROGRAMS THAT
STARTED DEVELOPING ACROSS THE
COUNTRY FOCUSED ON INDIVIDUALS
EXPERIENCING A FIRST EPISODE OF
PSYCHOSIS.
AND THAT NUMBER OF CLINICAL
PROGRAMS HAS BEEN INCREASING
SUBSTANTIALLY OVER THE PAST TEN
YEARS.
SO NIMH CREATED THE EARLY
PSYCHOSIS INTERVENTION NETWORK
IN RESPONSE TO COORDINATE SOME
OF THESE EFFORTS AND TO LEARN
FROM THESE EFFORTS.
SO, EPINET IS A NATIONAL LEARN
HEALTH CARE PARTNERSHIP THAT
BRINGS TOGETHER 101 OF THESE
EARLY PSYCHOSIS CLINICS ACROSS
16 STATES.
IT'S STRUCTURED AROUND 8 HUBS,
AND THEY COORDINATE RESEARCH
EFFORTS ACROSS THE 101 CLINICAL
SITES.
ALL LINKED TO THE DATA CENTER.
TOGETHER SITES AND HUBS COLLECT
DATA SYSTEMATICALLY ACROSS THE
SITES USING A CORE ASSESSMENT
BATTERY, UNIFORM DATA COLLECTION
METHODS, AND ALSO INTEGRATE DATA
ACROSS SERVICE USERS AND
CLINICS.
THIS PROCESS INVOLVES CLIENTS,
FAMILIES, CLINICIANS, HEALTH
CARE ADMINISTRATORS AND
SCIENTISTS, PARTNERED TOGETHER
WITHIN EPINET TO IDENTIFY
PROBLEMS, INNOVATE ON THE
SOLUTIONS, TO DEVELOP NEW
RESEARCH STUDIES, AND TO IMPROVE
CARE.
EPINET IS BEGINNING TO MAKE ITS
RESOURCES AVAILABLE TO OTHER
EARLY PSYCHOSIS PROGRAMS ACROSS
THE COUNTRY EVEN THOUGH IT'S NOT
INVOLVED IN THE NETWORK.
THE IDEA IS THAT THIS KIND OF
SYSTEM COULD BE EXPANDED TO
OTHER AREAS OF MENTAL HEALTH AND
MENTAL ILLNESS.
NEXT SLIDE.
MOVING TO THE SECOND TOPICAL
AREA UNDER MEETING THE MOMENT,
WE HAVE TRANSFORMING THE SYSTEM
OF CARE FOR YOUTH MENTAL HEALTH.
NEXT SLIDE PLEASE.
THERE IS WIDESPREAD INTEREST IN
UNDERSTANDING THE IMPACT OF
SOCIAL AND DIGITAL MEDIA USE ON
MENTAL HEALTH.
WE DO KNOW FROM RESEARCH THAT
CHILDREN AND ADOLESCENTS R
INCREASING ACCESS AND SPEND
INCREASING AMOUNT OF TIME
ENGAGING IN ONLINE SOCIAL
INTERACTIONS, AS WELL AS
CONSUMING CONTENT ON THESE
PLATFORMS.
UP TO 95% OF ADOLESCENTS REPORT
USING SOCIAL MEDIA PLATFORM WITH
MORE THAN A THIRD OF THEM SAYING
THEY USE SOCIAL MEDIA ALMOST
CONSTANTLY.
RESEARCH ALSO SHOWS US THAT
SCREEN TIME AND SOCIAL MEDIA
HAVE SOME BENEFITS AT LEAST FOR
SOME CHILDREN AND ADOLESCENTS,
THEY CAN PROVIDE MEANS OF
CONNECTION OR SUPPORT FOR THOSE
WHO SHARE COMMON INTERESTS OR
IDENTITIES.
BUT THERE'S ALSO EVIDENCE THAT
SOCIAL MEDIA USE INCREASES RISK
FOR MENTAL HEALTH PROBLEMS,
OTHER PROBLEMS LIKE SLEEP
DISRUPTION, AND THOSE PROBLEMS
TYPICALLY INCREASE AS USAGE
INCREASES.
EXEMPLIFIED ON THE SLIDE ON THE
RIGHT.
NEXT SLIDE.
THE STATE OF KNOWLEDGE IN THIS
AREA IS STILL QUITE LIMITED AND
NOT YET METHODOLOGICALLY
SOPHISTICATED.
NIMH IS SUPPORTING AN RFA ON
BIDIRECTIONAL INFLUENCES BETWEEN
ADOLESCENT SOCIAL MEDIA USE AN
MENTAL HEALTH, A BROAD
INITIATIVE, MOST THINGS THAT ARE
RELEVANT TO THIS ASSOCIATION
WOULD QUALIFY UNDER THIS RFA BUT
WE'VE PLACED EMPHASIS ON
UNDERSTANDING POSITIVE AND
NEGATIVE EFFECTS OF SOCIAL
MEDIA, ON FACTORS THAT INFLUENCE
RISK AND RESILIENCE AND USE OF
SOPHISTICATED AND FINE GRAIN
APPROACHES TO ASSESS AND BETTER
CONTEXTUALIZE SOCIAL MEDIA USE,
TO BETTER UNDERSTAND INDIVIDUAL
DIFFERENCES OF WHY IT HAS
POSITIVE IMPACT FOR SOME,
NEGATIVE FOR OTHERS.
WE'RE ALSO VERY INTERESTED IN
RESEARCH THAT PROVIDES INSIGHTS
INTO EITHER CLINICAL OR SOCIETAL
INTERVENTIONS THAT MIGHT HELP US
MITIGATE POTENTIAL HARMS.
THE REALITY IS SOCIAL MEDIA AND
DIGITAL MEDIA USE IS NOT GOING
AWAY AND THE QUESTION IS HOW CAN
WE BEST LEVERAGE THIS FOR GOOD?
NEXT SLIDE PLEASE.
ANOTHER AREA OF FOCUS IN YOUTH
MENTAL HEALTH IS YOUTH MENTAL
HEALTH DISPARITIES.
EARLY 2023, NIMH RELEASED A
STRATEGIC FRAMEWORK FOR
ADDRESSING YOUTH MENTAL HEALTH
DISPARITIES, SUMMARIZING OUR
PRIORITIES FOR GUIDING RESEARCH
IN THIS AREA WITH GOAL OF
REDUCING MENTAL HEALTH
DISPARITIES AMONG UNDERSERVED
AND UNDERREPRESENTED YOUTH BY
2031.
NIMH PARTNERED WITH NATIONAL
INSTITUTE ON MINORITY HEALTH AND
HEALTH DISPARITIES AND EUNICE
KENNEDY SHRIVER NATIONAL
INSTITUTE OF CHILD HEALTH AND
HUMAN DEVELOP ON THIS EFFORT,
ENGAGED WITH FEDERAL AGENCIES
AND RESEARCHERS AND CARE
PROVIDERS ACROSS THE COUNTRY
THROUGH A SERIES OF WORKSHOPS TO
INFORM THIS EFFORT.
THERE ARE THREE COMPONENTS, ONE
FOCUSING ON ADDRESSING RESEARCH
GAPS, ANOTHER ON ENGAGING STAKE
HOLDERS, AND THE THIRD ON
GROWING THE YOUTH MENTAL HEALTH
DISPARITIES WORKFORCE.
NEXT SLIDE.
ONE OF THE AREAS FOCUSED ON
YOUTH MENTAL HEALTH DISPARITIES
IS IN BLACK YOUTH SUICIDE BUT
THIS SLIDE HIGHLIGHTS THAT WE
HAVE A BROAD PROGRAM AND BETTER
UNDERSTANDING YOUTH SUICIDE
PREVENTION.
WE ARE FOCUSED ON BLACK YOUTH
SUICIDE AND PRE-TEEN SUICIDE,
WE'VE HOLD WORKSHOP AND WEBINARS
TO BRING TOGETHER DIVERSITY OF
PERSPECTIVES TO UP HAD US
UNDERSTAND WHAT WE KNOW, WHAT
RESEARCH IS NEED AND CHALLENGES
TO PROGRESS, AND BASED ON THOSE
DISCUSSIONS WE'VE BEEN ABLE TO
PUBLISH SOME INITIAL INITIATIVES
TO BEGIN TO ADDRESS THESE ISSUES
THROUGH RESEARCH BUT MUCH OF
THIS IS STILL UNDER DEVELOPMENT.
NEXT SLIDE PLEASE.
NOW I WANT TO MOVE TO OUR THIRD
AREA OF MEETING THE MOMENT IN
MENTAL HEALTH, THIS IS FOCUSED
ON LEVERAGING PRECISION MEDICINE
TO TRANSFORM THERAPEUTICS.
NEXT SLIDE PLEASE.
FOR PRECISION MEDICINE, WE ARE
LAUNCHING A RESEARCH PROGRAM
THAT WILL FOCUS ON TWO PARALLEL
AREAS OF NEED.
ONE ON BIOMARKER DEVELOPMENT,
THE OTHER ON PRECISION
DIAGNOSTICS.
NEXT SLIDE PLEASE.
I WANT TO TELL YOU ABOUT ONE OF
THE BIOMARKER EFFORTS.
THE GOAL SEEKS TO DEVELOP FAST,
ACCURATE, EASY-TO-USE ACCESSIBLE
TOOLS TO PREDICT RESPONSE ACROSS
MULTIPLE EXISTING TREATMENTS FOR
DEPRESSION.
OUR LONG-TERM GOAL HERE IS TO
ACTUALLY DEVELOP CLINICAL TOOLS
THAT A CLINICIAN CAN USE TO
ASSIGN A PATIENT WHO COMES TO
HIS OR HER OFFICE TO AN OPTIMAL
TREATMENT THAT WILL ENABLE THEM
TO ACHIEVE RAPID SYMPTOMATIC
RELIEF AND IMPROVE THE QUALITY
OF THEIR LIVES.
A FINAL APPROACH MODEL SOMEWHAT
AFTER ONE OF THE RADx
INITIATIVES, THAT'S MEANT TO
CREATE A FLEXIBLE RAPID PIPELINE
TO ACCELERATE DEVELOPMENT AND
VALIDATION OF THESE TOOLS OR
BIOMARKERS AND WILL INCORPORATE
EXPERTISE FROM THE TECH
INDUSTRY, REGULATORY AFFAIRS,
ALSO FROM BUSINESS.
THE NOTICE OF FUNDING
OPPORTUNITY IS NOW AVAILABLE, IT
IS NOT ON THIS SLIDE BECAUSE IT
CAME OUT AFTER I HAD CREATED THE
SLIDE.
BUT THAT ANNOUNCEMENT IS A
PHASED AWARD, THE FIRST PHASE IS
MEANT TO ALLOW SPACE FOR PILOT
OR SMALL STUDIES TO TEST THE
BIOMARKER OR TOOL, IF MILESTONES
ARE MET IN THE UH3 COMPONENT
INVESTIGATORS WOULD CONDUCT
LARGER CLINICAL TRIALS TO
VALIDATE THE USE OF THAT TOOL OR
BIOMARKER.
NEXT SLIDE.
SO IN THE OTHER AREA, AREA OF
PRECISION DIAGNOSTICS, OUR GOAL
IN THIS PARTICULAR EFFORT WHICH
I'M SHARING WITH YOU TODAY IS TO
USE DATA CENTRIC AND DATA DRIVEN
APPROACHES TO GENERATE MORE
SPECIFIC AND LESS BIASED
CLINICAL PHENOTYPES, WITH THE
HOPES THAT WOULD ENRICH OUR
APPROACHES TO DIAGNOSTICS,
PROGNOSTICS, TREATMENT DECISION.
MANY OF YOU KNOW RIGHT NOW OUR
CURRENT APPROACHES TO
UNDERSTANDING AND TREATING
MENTAL DISORDERS ARE LARGELY
BASED ON LONGSTANDING DIAGNOSTIC
CRITERIA, WHICH ARE BASED ON
PATIENT SELF-REPORT AND
CLINICIAN JUDGMENT, WE'RE TRYING
TO CREATE NON-BIASED APPROACHES
TO THIS.
NEXT SLIDE PLEASE.
THE RFA FOR THIS CONCEPT CLOSES
SOON.
IF YOU'RE INTERESTED, YOU'LL
HAVE TO WORK FAST, BUT THIS
NOTICE OF FUNDING OPPORTUNITY
CALLS FOR RESEARCH THAT USES
BEHAVIORAL MEASURES AND TOGETHER
WITH COMPUTATIONAL METHODS TO
DEFINE NOVEL CLINICAL SIGNATURES
THAT WE CAN USE FOR THIS
INDIVIDUAL LEVEL CLINICAL
DECISION MAKING.
IT TAKES A MULTI-COMPONENT
APPROACH, PLAN TO IDENTIFY
BEHAVIORAL TASK, COLLECT DATA
FROM NOVEL CLINICAL COHORTS, AND
DERIVE THOSE CLINICAL SIGNATURES
THROUGH COMPUTATIONAL METHODS.
NEXT SLIDE.
I'M GETTING TO THE END, ONE MORE
CONCEPT TO TELL YOU ABOUT IN OUR
LAST AREA WHICH IS DIVERSIFYING
GENETICS FOR NEXT GENERATION
TREATMENTS.
THIS IS JUST AN INTRODUCTORY
SLIDE TO GIVE YOU BACKGROUND.
FOR THOSE WHO KNOW, FOR THOSE
WHO DON'T, THERE'S REALLY BEEN A
DRAMATIC INCREASE IN NUMBER OF
GENES IDENTIFIED FROM GENETIC
ASSOCIATION STUDIES, AS BEING
LINKED TO RISK FOR THESE
DISORDERS.
THAT OFTEN NUMBERS IN THE
HUNDREDS.
AND EXAMPLE SHOWN HERE IS FOR
SCHIZOPHRENIA, NUMBER AROUND
250.
RESEARCH THAT FOLLOWS FOCUS ON A
SMALL FRACTION OF THESE GENES,
WHICH THEN LIMITS OUR ABILITY TO
DETERMINE WHERE GENETIC RISK
CONVERGES WITH BIOLOGY IN TERMS
OF CELL TYPES, SIGNALING
PATHWAYS, CIRCUITS AND STAGES OF
BRAIN DEVELOPMENT.
NEXT SLIDE.
SO, THE FRAMEWORK IS AN EFFORT
TO TRY TO MORE SYSTEMATICALLY
CHARACTERIZE FUNCTION OF GENES
ASSOCIATED WITH RISK FOR
PSYCHIATRIC DISORDERS, AND
REVEALED MECHANISMS THAT
UNDERLIE DISORDERS.
IT'S ENVISIONED, THIS CONCEPT IS
ENVISIONED AS TIERED OR PHRASED
APPROACH, WITH THROUGHPUT
SCREENS THROUGH DEEP
HIGH-THROUGHPUT SCREENS AND GOES
INTO CASES 2 AND 3 FOCUSING ON
DEEP TARGETED LOWER THROUGHPUT
INVESTIGATIONS.
WE ARE ALREADY -- HAVE STARTED
FUNDING PHASE 1, CURRENTLY BEING
SUPPORTED TRUE -- THROUGH GRANS
IN MAY, FOCUSING ON SCALABLE
TECHNOLOGIES THAT WILL
CHARACTERIZE BETWEEN 100 AND 250
KNOCKOUTS OF THESE GENES, ACROSS
BIOLOGICAL SCALES OF
ORGANIZATIONS, AND AS I
MENTIONED THE NEXT PHASES ARE
REALLY ENVISIONED AS A
PROGRESSIVELY DEEPER DIVE INTO
FUNDAMENTAL BIOLOGY.
NEXT SLIDE PLEASE.
I'M GOING TO LEAVE YOU HERE.
I WANT TO THANK YOU FOR YOUR
ATTENTION, FOR HAVING ME TODAY,
I WELCOME YOUR COMMENTS AND YOUR
QUESTIONS.
>> THANKS, SHELLI, APPRECIATE
ALL THE AREAS YOU LAID OUT AND
THE WORK THAT NIMH IS DOING TO
ADDRESS THIS IMPORTANT -- THESE
IMPORTANT TOPICS.
TESHA, I SEE YOUR HAND UP.
>> I WAS HOPING TO GO LAST.
OKAY.
I REALLY WANT TO THANK YOU FOR
THAT PRESENTATION, ALL THE
EXCITING STUFF YOU'RE GOING TO
ADDRESS THESE IMPORTANT ISSUES
IN YOUR COMMUNITIES AND
COMMUNITIES SUFFERING FROM
MENTAL HEALTH STEMMING FROM MANY
THINGS.
ONE IS VIOLENCE.
I'M GOING TO BRING THIS UP
BECAUSE THIS IS THE ONLY PLACE
IT SEEMS TO FIT.
IT'S RELATIVE TO THE SOCIETAL
ISSUE.
I WANT TO FOCUS ON A FEW
COMMENTS AND THOUGHTS.
AND THEN I'LL JUST -- IT'S NOT
REALLY A QUESTION.
IT'S, AGAIN, A RECOMMENDATION
FOR NIH TO TAKE ADVANTAGE OF ALL
OF ITS OPPORTUNITIES TO ADDRESS
VIOLENCE IN THE U.S., IN ALL ITS
FORMS, ACROSS THE CONTINUUM OF
AGE, ETHNICITY, RACE, GENDER,
COMMUNITIES, I THINK WE SEE HOW
VIOLENCE HAS -- GIVE ME A
MINUTE.
HAS IMPACTED ALL OF US.
I WANT TO ENCOURAGE CREATIVITY
AND INNOVATION IN THE CALL FOR
RESEARCH THAT ADDRESSES THESE
ISSUES AND THINK ABOUT THEM IN A
CROSS--SOCIOLOGICAL SITE FROM A
MENTAL HEALTH ISSUE BUT AN
INDIVIDUAL'S MENTAL HEALTH, BUT
ALSO THINKING ABOUT FROM THE
COMMUNITY PERSPECTIVE.
DISPARITIES HAPPENING IN
COMMUNITIES.
WE TALKED ABOUT TECHNOLOGY AND
YOU TALKED ABOUT TECHNOLOGY ON
BOTH SIDES OF THE COIN.
IT'S REALLY IMPORTANT TO
UNDERSTAND HOW DO WE USE
TECHNOLOGY, AND HOW DO WE THINK
ABOUT IT, HOW DO WE ADDRESS IT
FROM POLICY TO INDIVIDUAL USE,
INTO USING IT AS A PREVENTION OR
TREATMENT TOOL.
THANK YOU FOR THAT.
WE NEED MORE OF THAT.
WE NEED HAVE RESEARCH THAT
FOCUSES ON POLICY AND SYSTEMS.
WHERE DO WE HAVE POLICIES AND
SYSTEMS THAT DO BOTH, THAT
ENCOURAGE VIOLENCE WHEN WE DON'T
SEE -- DON'T NECESSARILY MEAN
FOR THAT TO HAPPEN BUT IT'S
HAPPENING ACROSS COMMUNITIES, IN
STATES, HOW WE ADDRESS HATE
SPEECH, HOW WE ADDRESS GUNS, HOW
WE ADDRESS OWNERSHIP IN THE WAY
PEOPLE INTERACT WITH ONE
ANOTHER.
AND IN THOSE SPACES THAT ARE
PUBLIC BUT ALSO PRIVATE.
HOW DO WE EFFECT POLICIES AND
ADDRESS RESEARCH TO LOOK AT THAT
AS WELL AS THROUGH SYSTEMS, WHAT
ARE SYSTEMS GOING ON, WHAT
WORKS?
SO BEING ABLE TO LOOK AT OTHER
COMMUNITIES, LOOKING AT OUR
RATES, OUR STATS COMPARED TO
OTHER COUNTRIES, BOTH IN WHAT'S
HAPPENING, MORTALITY OR
MORBIDITY IS ONE THING BUT NIH
HAS AN OPPORTUNITY TO GO BEYOND
THAT.
WHAT WORKS?
WHAT POLICIES WORK?
WHAT SYSTEM AFFECTS WORK?
HOW DO WE LET PEOPLE KNOW ABOUT
THAT?
BOTH AS WE WERE TALKING ABOUT
DATA THAT'S AVAILABLE TO THE
PUBLIC BUT ALSO TO LEGISLATURES,
YOU HAVE AN OPPORTUNITY TO SPEAK
TO THAT AS WELL AS ANY STATE OR
OTHER KINDS OF GOVERNING SYSTEMS
THAT MIGHT BE INTERESTED IN
THAT.
AND LOOKING ACROSS STATES, WHAT
DO WE HAVE?
NOT JUST ABOUT GUNS, YOU'RE
ADDRESSING FROM A BASIC LEVEL,
WHAT HAPPENS?
WHAT HAPPENS AT THE MENTAL
HEALTH LEVEL?
AND HOW DO WE ADDRESS THAT AND
HELP THAT?
TO APPLY THAT, ALL ACROSS THAT,
TO THINK ABOUT VIOLENCE AS FROM
NIH-SPEAK, DISEASE.
IF VIOLENCE IS A DISEASE HOW DO
WE ADDRESS IT, EXPLORE WHAT'S
GOING ON AND CAUSING THIS, NOT
JUST SELF-HARM BUT HARM TO
OTHERS.
NOT JUST THE PEOPLE WHO SUFFER
FROM IT BUT THE PEOPLE WHO
DELIVER IT.
HOW DO WE REALLY TAKE A HOLISTIC
PERSPECTIVE OF VIOLENCE AND
TAKING CARE OF PEOPLE?
PARTICULARLY SMALL CHILDREN.
THANK YOU.
>> I JUST WANT TO THANK YOU SO
MUCH FOR THOSE COMMENTS,
ACKNOWLEDGE THEM.
IT WASN'T A QUESTION BUT MY VERY
BRIEF REPLY IS THIS IS A
DIALOGUE THAT WE'RE HAVING
ACROSS NIH.
IT'S NOT AN NIMH-SPECIFIC
QUESTION AS YOU SUGGESTED, NOT
SPECIFIC TO MENTAL HEALTH.
WE ALL SUPPORT DIFFERENT
COMPONENTS OF IT, I APPRECIATE
YOUR SUGGESTION OF TAKING A MORE
HOLISTIC APPROACH.
THAT MAKES A LOT OF SENSE.
SO THANK YOU VERY MUCH.
>> BRIAN?
>> THANK YOU FOR THAT
PRESENTATION.
I WANTED TO ASK YOU SPECIFICALLY
ABOUT WORK ON THE LGBTQ
COMMUNITY, PARTICULARLY LGBTQ
YOUTH.
CDC DATA SHOWS THAT AT LEAST ONE
IN FIVE TEENS IDENTIFY AS LGBTQ
NOW, AND THEIR DATA SHOW THAT
ALMOST 70% REPORTED SEVERE
PATTERNS OF BEING SAD OR
DEPRESSED OR HOPELESS, AND
THAT'S OVER TWICE THE NUMBER OF
HETEROSEXUAL YOUTH, THEIR DATA
SHOW THAT THESE YOUTH WERE MOST
IMPACTED BY THE COVID PANDEMIC,
FOUR TIMES MORE LIKELY TO
ATTEMPT SUICIDE AND HETEROSEXUAL
PEERS, LONGSTANDING PATTERNS
EXACERBATED MORE BY COVID.
I WOULD SAY IN MY EXPERIENCE
OBSERVING SOME OF THE YOUTH,
MENTAL HEALTH RESEARCH
PRIORITIES AND PRACTICE
PRIORITIES, LGBTQ YOUNG PEOPLE
ARE INCONSISTENTLY INCLUDED AND
IDENTIFIED DESPITE THE CDC DATA
SHOWING REALLY DRAMATIC AND
ALARMING TRENDS, AND I WONDER IF
YOU COULD TALK ABOUT HOW YOU SEE
THEM INCLUDED IN THIS WORK.
>> THANK YOU SO MUCH.
ABSOLUTELY.
WE REALLY HAVE A VERY BROAD AND
RICH -- BROAD AND DEEP PORTFOLIO
ON SUICIDE PREVENTION, SUICIDE
RISK AND PREVENTION EFFORTS
WITHIN NIMH.
I ONLY WAS ABLE TO TELL YOU
ABOUT A LITTLE BIT.
MAINLY BECAUSE WE'VE BEEN
FOCUSED ON SOME OF THE RECENT
TRENDS.
YOU'RE RIGHT, WE HAVE A NUMBER
OF INVESTMENTS ALREADY FOCUSED
ON LGBTQ+ YOUTH.
WE HAVE HAD INITIATIVES WHERE
WE'VE DONE A LOAN, A PARTNERED
WITH OTHERS TO UNDERSTAND RISK,
AND MORE IMPORTANTLY TO BETTER
UNDERSTAND HOW BEST TO IDENTIFY
AND INTERVENE EARLY, AND THINK
THAT'S AN IMPORTANT KEY HERE.
WE ALSO HAVE RIGHT NOW ON THE
STREET, WHILE SOME OF OUR
RESEARCH FOCUS HAS BEEN ON
UNDERSTANDING RISK AMONG BLACK
YOUTH, WE'VE EXPANDED THAT
RECENTLY SO WE HAVE AN
ANNOUNCEMENT OUT NOW THAT
FOCUSES ON VULNERABLE AND
UNDERREPRESENTED YOUTH OF ALL
KINDS BECAUSE WE RECOGNIZE THAT
THE NEEDS -- THE WAYS THAT WE
WILL GO ABOUT IDENTIFYING AND
UNDERSTANDING RISK AND HOW WE
WILL GO ABOUT INTERVENING DOES
DIFFER BY VARIOUS SUBPOPULATIONS
SO WE HAVE A CALL OUT RIGHT NOW
TO DO THAT.
AND A GOOD PART OF OUR PORTFOLIO
REALLY DOES FOCUS ON VULNERABLE
AND UNDERREPRESENTED PEOPLE MORE
SO THAN MORE BROADLY.
THANK YOU.
>> SEXUAL AND GENDER MINORITY
PORTFOLIO ANALYSIS THERE ARE
VERY FEW STUDIES SO I THINK IT'S
SOMETHING I'D LOVE TO SEE GROWTH
IN THAT PORTFOLIO.
>> I WOULD -- WE VERY MUCH
APPRECIATE ANY THOUGHTS YOU
HAVE.
WE HAVE HAD ROUNDTABLES ON THIS
TOPIC AS WELL.
HOW WE CAN ENGAGE MORE PEOPLE TO
FOCUS ON THIS AS AN AREA OF
RESEARCH, SO IN SOME WAYS WE
HAVE BEEN COMMUNICATING AS A
PRIORITY BUT IN OTHER WAYS NOT
ALWAYS DRAWING PEOPLE TO THE
AREA, SO WE'RE VERY OPEN IF YOU
OR OTHERS HAVE SUGGESTIONS AND
HOW TO DO A BETTER JOB OF
REACHING INVESTIGATORS AND
ENCOURAGING THEM IN THIS SPACE.
>> YEAH, JUST ONE QUICK IDEA.
I THINK IT'S AN AREA WHERE WE
NEED TO GROW INVESTIGATORS,
SCIENTIFIC WORKFORCE OF PEOPLE
EXPERIENCED WORKING WITH THIS
COMMUNITY, PARTICULARLY IN THE
MENTAL HEALTH AREA, THERE'S A
LARGE NUMBER OF INVESTIGATORS IN
THIS AREA WORKING ON HIV BUT
MUCH SMALLER IN MENTAL HEALTH
AND SUICIDE.
K AWARDS, F32, TRAINING GRANTS
TO GROW WORKFORCE ARE NEEDED TO
GET FOLKS TO THE PLACE TO APPLY
FOR R01s.
>> GREAT SUGGESTION, THANK YOU.
>> LUCILA?
>>MY QUESTION IS RELATED TO
YOUR CHARGE ON THE SOCIAL MEDIA,
WHICH IS QUITE STRIKING.
IS IT PERCEIVED AS AN ADDICTION,
AND THEREFORE ADDRESSED THAT
WAY?
AND WHAT'S THE ROLE OF THE
SOCIAL MEDIA PLATFORMS TO
CONTRIBUTE SOMEHOW TO FIX THIS
ISSUE?
>>GREAT QUESTIONS.
SO, I WOULD SAY WE HAVE MULTIPLE
LEVELS OF INVOLVEMENT HERE.
TODAY I TOTAL -- TOLD WHAT YOU
WE'RE DOING IN OUR OWN RESEARCH,
WE'RE RESPONSIBLE FOR DEVELOPING
RESEARCH PRIORITIES IN THIS
SPACE.
OUR SURVEY OF THE LITERATURE IS,
AS I SAID, IT'S VERY NEW, IT'S
NOT WELL DEVELOPED, AND IT
REALLY NEEDS TO IMPROVE
METHODOLOGICALLY TO BE
SOPHISTICATED INSTEAD OF SAYING
X NUMBER OF HOURS ON SCREENS IS
BAD, UNDERSTANDING WHAT IT IS
ABOUT THAT TIME, IS IT EXPOSURE
TO CONTENT, IS IT THE FACT THAT
YOU'RE NOT DOING OTHER THINGS
LIKE SLEEPING OR ENGAGING WITH
PEERS?
YOU KNOW, FACE TO FACE.
SO THERE'S A LOT MORE THAT NEEDS
TO BE LEARNED IN THAT.
ASIDE FROM OUR OWN RESEARCH
AGENDA OF TRYING TO FILL GAPS IN
OUR UNDERSTANDING, WE'VE HAD
THAT FORTUNATE OPPORTUNITY TO
ENGAGE WITH A LOT OF DIFFERENT
PEOPLE WITH A LOT OF
PERSPECTIVES IN THIS AREA, AND I
THINK WE'RE ALL MOVING
ESPECIALLY WITHIN HHS TO BE
WORKING TOGETHER ON THESE
ISSUES, TO INFORM ACROSS
AGENCIES, ON WHAT KIND EVER
RESEARCH IS NEEDED TO INFORM
SERVICE DELIVERY, INFORM THE
DEVELOPMENT OF REGULATIONS
AROUND COVID-19, THINGS LIKE
THAT.
SORRY, REGULATIONS AROUND SOCIAL
MEDIA USE.
AND YOU ASK -- DID I GET ALL OF
YOUR QUESTION OR MISS A
COMPONENT?
OH, YOU ASKED ABOUT SOCIAL MEDIA
PLATFORMS.
THAT'S TRICKIER.
I THINK WHAT WE'RE TRYING TO DO
IS IN DISCUSSIONS IS ENGAGE WITH
LARGER GROUPS IN DISCUSSIONS
ABOUT WHAT CAN BE DONE.
THIS IS AN EXAMPLE THROUGH THE
NATIONAL ACTION ALLIANCE FOR
SUICIDE PREVENTION, NIMH IS PART
OF THE NATIONAL ACTION LINE FOR
SUICIDE PREVENTION, THERE ARE
MEMBERS FROM BOTH PUBLIC AND
PRIVATE ORGANIZATIONS HERE.
WE'VE TRIED TO WORK TOGETHER TO
BRING, FOR EXAMPLE, FACEBOOK TO
OUR MEETINGS, TO OTHER EVENTS TO
TALK ABOUT OUR CONCERNS ABOUT
ONLINE CONTENT OR THINGS, AND
THEN HAVE DIALOGUE AROUND THOSE
TOPICS.
SO I CAN SAY WE'RE TRYING TO
ENGAGE IN THOSE DISCUSSIONS AND
THEN WHEN WE CAN TRYING TO DO
RESEARCH AROUND UNDERSTANDING
THE COMPLEXITIES OF THOSE
ASSOCIATIONS.
>>THANK YOU SO MUCH.
>> AS SHELLI ALLUDED TO, MANY
OF THESE PROBLEMS WHICH ARE OF
COURSE SOCIETAL IN NATURE
TRANSCEND JUST NIMH OR INDEED,
YOU KNOW, THE DEPARTMENT.
BUT INCREASINGLY, AND UNDER THE
DEPARTMENT'S LEADERSHIP, I HAVE
TO SAY WE'RE DOING MORE AND MORE
ACROSS THE DEPARTMENT
ENGAGEMENT, AND NIMH OF COURSE
IS LEADING IN A NUMBER OF THESE
AREAS.
AND I THINK THAT'S A REALLY GOOD
DIRECTION THAT IS BEING FOLLOWED
BECAUSE WE'RE JUST GOING TO NEED
MORE ENGAGEMENT ACROSS THE
GOVERNMENT, QUITE FRANKLY, TO
MEET ALL OF THESE INCREDIBLE
CHALLENGES.
I KNOW WE ALL WOULD LIKE TO
THINK AS NIH-ERS, THAT WE CAN
SOLVE ALL THE PROBLEMS, BUT I
THINK SOME OF THESE WE REALLY DO
HAVE TO COUNT ON EXTENSIVE
PARTNERSHIPS.
AS YOU CONSIDER THESE DIFFERENT
CHALLENGES, YOUR SUGGESTIONS
ABOUT OTHER PARTNERS, YOU KNOW,
AND MAYBE PARTNERS THAT WE
HADN'T CONSIDERED, BECAUSE MAYBE
IT'S NOT SELF-EVIDENT, BUT IT
WOULD BE HELPFUL FOR YOU TO
PROVIDE US YOUR SUGGESTIONS IN
THAT REGARD.
TARA, I DON'T SEE ANY ADDITIONAL
HANDS BEING RAISED.
ANY OTHER COMMENTS BY -- AH,
THERE'S BARBARA.
>> BARBARA, YEAH.
>> I'M SORRY TO BE VISUALLY ON
MUTE.
BUT I WAS VERY IMPRESSED WITH
THIS, AND IT IS AS LARRY SAYS IN
DIFFERENT WORDS, AN INCREDIBLY
IMPORTANT BOIL THE OCEAN SIZE
PROBLEM, THE DIFFICULT THING FOR
NIH AND NIMH IN WHAT PARTS CAN
WE BE THE TIP OF THE SPEAR
PROVIDING A SOLUTION MUCH BIGGER
THAN WHAT NIH ALONE CAN DO,
WHICH GOES BACK TO EARLY SLIDE
ABOUT EPI.
I WAS IMPRESSED WITH THE VOLTAGE
DROP PROP AND HOW EPI IS
ACTUALLY PART OF THAT SOLUTION
ALREADY.
AND WHAT I DID NOT GET
NECESSARILY THAT I HAD HOPED,
MAYBE THAT WAS ME, WAS IS THERE
A PART OF EXPANDING ON EPI,
EXPANDING IN PARTICULAR PERHAPS
FEEDBACK COMING BACK THROUGH
SOCIAL MEDIA, TO GET MORE
EVIDENCE-BASED INFORMATION AS
QUICKLY AS POSSIBLE ON WHICH
THINGS ARE EFFECTIVE TO WHICH
COMMUNITIES, AND WHAT NEEDS TO
BE AMPLIFIED IN DELIVERY BY THE
MUCH LARGER ENTERPRISE.
SO, WHERE COULD WE PUT MORE
RESOURCES RIGHT AWAY MOST
EFFECTIVELY?
>> THANK YOU FOR THAT.
VERY DIFFICULT QUESTION.
>> SORRY!
>>NO, IT'S -- YOU ARTICULATED
IT VERY WELL.
IT'S A CHALLENGE TO FIGURE OUT
WHERE WE CAN MAKE THE BIGGEST
IMPACT, PARTICULARLY WHEN WE
HAVE A LARGE NUMBER OF AREAS
THAT WE'RE TRYING TO COVER,
MENTAL DISORDERS, THERE ARE MANY
DIFFERENT KINDS.
AND MANY DIFFERENT NEEDS, WITHIN
EACH ARE A VARIETY OF DIFFERENT
WAYS, AREAS WHICH WE COULD
FOCUS.
GOING BACK TO EPINET THE IDEA,
THIS IS ONE STRUCTURE THAT WE
CREATED TO TRY TO ALLOW IN REAL
TIME THE ABILITY TO MODIFY AND
IMPROVE CARE.
AND THAT MODEL HAS BEEN USED BY
OTHERS, NOT JUST NIMH.
IT WAS A MODEL I THINK INITIALLY
PUT OUT BY INSTITUTE OF MEDICINE
BUT THE IDEA IS WE COULD EXPAND
THAT AND DO THAT IN OTHER AREAS
OF HEALTH.
THOSE ARE USUALLY SET WITHIN
HEALTH CARE SYSTEMS.
>> WHAT I WAS INTERESTED IN WAS
FUSING THAT TO FEEDBACK SO IT
BECOMES A SOURCE OF
EVIDENCE-BASED IMPROVEMENT AS
WELL AS SIMPLY A VERY GOOD WAY
TO GIVE OUR BEST MORE
EFFECTIVELY.
>> THAT'S HOW IT WORKS, WHAT
YOU SAID IS HOW IT WORKS WITHIN
THESE HEALTH CARE SYSTEMS,
WITHIN THESE CLINICS THAT ARE
LINKED TO THIS.
THEN YOU MENTIONED SOCIAL MEDIA,
SO I'M WONDERING IF YOU MEAN
FEEDBACK ON WHAT WE LEARN ABOUT
THESE THINGS MORE GENERALLY.
>> I DO.
SO START WITH THAT AND THEN GO
BIGGER IN A WAY THAT REQUIRES
PERHAPS A DIFFERENT
INFRASTRUCTURE TO BE COLLECTING
INFORMATION BACK FROM SOCIAL
MEDIA BECAUSE OBVIOUSLY YOU'RE
STARTING WITH A VERY ACUTE AND
SPECIAL GROUP EARLY ONSET
PSYCHOSIS, AND THE PROBLEM WE
HAVE IS A MUCH LARGER
ENVIRONMENTAL ONE FALLING ON
POSSIBLY EVERYBODY OR A VERY
LARGE PERCENTAGE OF POPULATION
WHERE ANSWERS MAY BE DIFFERENT.
SO THE QUESTION IS WHETHER
THERE'S A WAY TO EXTEND OR
WHETHER WE HAVE TO THINK ABOUT
IT VERY DIFFERENTLY.
>> I THINK WE CAN EXTEND, IS
ONE SOLUTION BUT THERE ARE OTHER
ASPECTS THAT WILL REQUIRE
DIFFERENT APPROACHES AND I HAVE
MENTIONED, LARRY ALSO SUPPORTED
THIS, THAT AROUND THE ISSUE OF
SOCIAL MEDIA ENGAGEMENT AND
YOUTH, BEING ABLE TO HAVE THESE
CONVERSATIONS ACROSS AGENCIES
AND GROUPS, WE SUPPORT THE
RESEARCH.
WE MIGHT FIT THE PRIORITIES BUT
WE SUPPORT THE RESEARCH AND
ULTIMATELY TO MOVE INTO FEEDBACK
MECHANISMS TO MAKE DIFFERENCES
WE NEED OTHER AGENCY INVOLVEMENT
IN THAT.
AND SO I THINK SOCIAL MEDIA,
IT'S BEEN FANTASTIC WITH ENOUGH
WIDESPREAD ATTENTION AND ALSO
WITH THE CONGRESSIONAL AND WHITE
HOUSE INTEREST IN THIS SPACE,
POTENTIAL RESOURCES TO ACTUALLY
MAKE THIS HAPPEN IN THAT AREA.
>> THANK YOU.
>> TESHIA?
>> YEAH, THANK YOU.
I WANTED TO FOLLOW UP, AND DR.
TABAK, YOU KNOW ME WELL ENOUGH
AND OTHERS KNOW I'M ALWAYS
PUSHING.
I'M GOING TO PUSH THE ENVELOPE
HERE.
AND SAY THAT DON'T UNDERESTIMATE
YOURSELVES OR THE POWER THAT YOU
HAVE, DON'T UNDERESTIMATE
SUCCESSES YOU HAVE, OR DON'T
UNDERESTIMATE THE VOICES AND
REACH THAT YOU HAVE.
SO YOU DRAW UPON THIS INCREDIBLE
WEALTH OF INTELLIGENT PEOPLE OUT
THERE IN THE WORLD THAT YOU GET
TO DRAW UPON THEIR WEALTH, THEIR
INTELLIGENCE, FOR INNOVATION AND
CREATIVITY.
YOU'VE BEEN SUCCESSFUL.
COVID SHOWED US.
YOU SPOKE ABOUT HOW GREAT YOU
GUYS HAVE BEEN AT WORKING WITH
OTHER DEPARTMENTS AND OTHER
GROUPS WITHIN THE HHS AND
BEYOND, CORPORATE, WHATEVER.
I'M JUST SAYING TAKE IT.
TAKE THE OPPORTUNITY EVERY
CHANCE YOU GET.
I'M ASKING EVERYBODY, TAKE THIS
OPPORTUNITY TO SAY THAT WE WILL
NOT PUT UP WITH THE VIOLENCE
THAT'S GOING ON.
WE WILL NOT WATCH ANY MORE
CHILDREN DIE.
AND WE'RE GOING TO DO EVERYTHING
WE CAN TO ADDRESS IT.
WE HAVE THE OPPORTUNITY THROUGH
NIH AND THE THINGS YOU'RE SO
GOOD AT.
AND LOOKING AT THIS AS A DISEASE
ENTITY, NOT BODY PART, IT'S A
DISEASE.
IT'S HAPPENING AND IT'S AN
EPIDEMIC.
THANK YOU.
>> THANK YOU SO MUCH.
REALLY APPRECIATE THAT.
>> THANKS FOR YOUR COMMENTS.
COREY, WE'LL GIVE YOU THE FINAL
WORD.
>> WE CAN'T HEAR YOU.
>> CAN YOU HEAR ME NOW?
>> NO, WE CAN'T, UNFORTUNATELY.
>> BARELY.
VERY FAINT.
>> OKAY.
WHAT ABOUT NOW?
>> SLIGHTLY.
YOU CAN GIVE IT A TRY BUT WE
CAN'T HEAR YOU SUPER WELL, I'LL
SEE IF I CAN TRANSLATE.
>> OKAY.
I HAVE MORE OF A STATEMENT THAN
A QUESTION.
MY STATEMENT HAD TO DO WITH THE
NEED FOR A LENS IN TERMS OF
LOOKING AT BEHAVIORAL OUTCOMES,
SUICIDE RATE OUTCOMES.
THE DATA IS FRIGHTENING IN TERMS
OF SOME OF THE ISSUES RELATING
TO YOUTH AND SUICIDE RATES.
HOWEVER, THERE MAY BE A NEED TO
LOOK AT THE INTERSECTION OF
SUBGROUPS TO INCLUDE
RACE/ETHNICITY, LGBTQ STATUS, IN
YOUTH RESIDING IN LOCATIONS OF
THE UNITED STATES, WITH POVERTY,
MIGHT HELP IDENTIFY A DEEPER
UNDERSTANDING, DEEPER
UNDERSTANDING WHAT THE NEED IS
IN TERMS OF -- THE PARADIGM
(INDISCERNIBLE) FROM LOOKING AT
RACE/ETHNICITY AND OTHER
IDENTITY AS AN ISOLATED FACTOR,
IT'S APPARENT THE NEED TO LOOK
AT HOW THESE SUBGROUPS INTERSECT
WITH OTHER SUBGROUPS, TO GET AT
WHERE THE PROBLEM IS.
>> THANK YOU SO MUCH.
FOR THOSE WHO MIGHT HAVE NOT
HEARD, THE FOCUS WAS REALLY ON
DOING A BETTER JOB OF TAKING AN
INTERSECTIONAL LENS TO REALLY
HELP US IDENTIFY WHERE THE NEED
IS AND LEAD OUR EFFORTS GOING
FORWARD.
THAT WAS VERY BRIEF.
THANK YOU FOR THAT.
AND YOU'RE ABSOLUTELY RIGHT,
SOMETHING WE'RE TRYING TO DO A
BETTER JOB OF.
SOMETIMES WE HAVE DATA AT
INTERSECTIONAL LEVEL, SOMETIMES
WE DON'T.
IT'S IMPORTANT TO KEEP IN MIND
AND MAKE SURE WE INCORPORATE
INTO HOW WE DISCUSS THOSE
ISSUES, APPRECIATE THAT.
>> WITH THAT, WE HAVE A ANOTHER
BREAK SCHEDULED FOR THE AGENDA,
SO, SHELLI, THANK YOU AGAIN FOR
THE PRESENTATION.
WE'LL TAKE THE OPPORTUNITY TO GO
ON A COUPLE-MINUTE LONG BREAK.
WE'LL BE BACK AT 3:00 FOR THE
NEXT PRESENTATION.
WE'LL SEE YOU ALL IN 18 MINUTES.
>>WE'LL GET GOING ON THE LAST
COUPLE SESSIONS OF THE DAY.
AND HERE TO START THAT OUT FOR
US IS DR. GARY GIBBONS, HEAD OF
NATIONAL HEART, LUNG AND BLOOD
INSTITUTE TO TALK A BIT ABOUT
SOME EFFORTS THAT HE AND OTHERS
ACROSS THE AGENCY ARE WORKING ON
AROUND POST-ACUTE SEQUELAE OF
SARS-COV-2, LONG COVID, TO TALK
ABOUT SPECIFICALLY RECOVER
INITIATIVE.
GARY?
>> THANK YOU VERY MUCH.
APPRECIATE THIS OPPORTUNITY TO
PRESENT TO THE ACD, ON BEHALF OF
CO-CHAIRS AND SENIOR LEADERSHIP
TEAM AND RECOVER CONSORTIUM.
NEXT SLIDE PLEASE.
AS LEVEL SETTING AND REMINDER OF
PREVIOUS UPDATES TO ACD, THE
GOAL TO CLEARLY RAPIDLY IMPROVE
OUR UNDERSTANDING OF ABILITY TO
PREDICT, TREAT, PREVENT LONG
COVID, THE OVERARCHING OBJECTIVE
OF RECOVER.
AND IT HAS THE SAME KEY SPECIFIC
AIMS THAT RELATE TO EXTENDING
AND UNDERSTANDING OF THE
CLINICAL SPECTRUM, AND THE
UNDERLYING TRAJECTORIES OF
RECOVERY, AS TO WHO GETS IT AND
WHO DOES NOT GET PASC, RISK
FACTORS, INCIDENCE, PREVALENCE,
DISTINCT PASC PHENOTYPES, TO
STUDY THE PATHOGENESIS,
UNDERLYING ETIOLOGIES OF THE
BROAD SYMPTOM COMPLEX THAT
CHARACTERIZES LONG COVID AS WELL
AS IMPLICATIONS FOR ORGAN
DYSFUNCTION AND PERHAPS MOST
IMPORTANTLY EVENTUALLY AS WE GET
THIS KNOWLEDGE TO TREAT AND
PREVENT THE POST-ACUTE SEQUELAE
OF COVID AND LONG COVID.
WE'VE BEEN OPERATING SINCE
INCEPTION WITH PATIENT-CENTERED
APPROACH, OPERATING PRINCIPLE,
PARTICIPANTS ARE PARTNERS,
CO-CREATING THE RECOVER
PLATFORM, AS WELL AS EVERY
ELEMENT OF THE STUDY FROM DESIGN
AND PROTOCOLS TO IMPLEMENTATION
EXECUTION.
KEY GUIDING PRINCIPLE TO CREATE
THIS NATIONAL SCALE, WITH
INCLUSIVE DIVERSE PARTICIPATION
AND ENGAGEMENT OF COMMUNITIES,
AND HOPEFULLY IT'S EVIDENT THAT
WE'RE WELL ON OUR WAY TO PUTTING
THAT PRINCIPLE IN ACTION.
IN ADDITION AS WE DEVELOP THIS
ReCOVer PLATFORM WE LEVERAGE
IT AS A PLATFORM THAT ENABLING
US TO DO SCIENCE AT SALE AND
SPEED OF SCOPE BY SCOPE BY
PROVIDING COMMON DATA ELEMENTS,
AGAIN APPROACHES THAT ALLOW FOR
COMPREHENSIVE INTEGRATED
ANALYSIS OF DATASETS AND TRIALS.
FINALLY APPROACHING WITH GREAT
HUMILITY, THAT THERE'S A LOT WE
KNOW BUT WE HAVE TO KEEP
ADAPTING NOT ONLY TO THE CORES
OF THE PANDEMIC BUT ALSO AS WE
LEARN AND NEW SCIENTIFIC
OPPORTUNITIES EMERGE THAT WE
MAINTAIN A CERTAIN ADAPTIVE
NIMBLENESS.
NEXT SLIDE PLEASE.
TOWARD THAT END, PRINCIPLES IN
ACTION OF MEANINGFUL PATIENT
ENGAGEMENT, AS PARAMOUNT
PRINCIPLE, WE'VE ENDEAVORED TO
MAKE ReCOVer SET A HIGH
STANDARD, HIGH BAR FOR PATIENT
ENGAGEMENT.
TO WE DON'T ALWAYS GET IT RIGHT
WITH HICCUPS AND SPEED BUMPS
ALONG THE WAY BUT I THINK
OVERALL THE NET OUTCOME HAS BEEN
THIS HAS BEEN INCREDIBLE PLUS TO
BE WORKING WITH PATIENTS AND
PARTICIPANTS AS PARTNERS, ALL
STAKEHOLDERS GAINED FROM
PERSPECTIVES OF LIVED EXPERIENCE
OF PATIENTS AT EVERY LEVEL OF
THE ReCOVer INITIATIVE
WHETHER AT THE NATIONAL
ENGAGEMENT GROUP WHICH IS THE
CENTRAL CORE FUNCTION AND CORE
ELEMENT, GOVERNANCE STRUCTURE
THAT REALLY FOCUSES IN ON THE
PATIENT PERSPECTIVE BUT WHETHER
IT'S THE STEERING COMMIT,
EXECUTIVE COMMITTEE, SCIENTIFIC
WORK GROUPS AND OVERSIGHT
COMMITTEES, PATIENTS ARE
CO-AUTHORS ON MANY PUBLICATIONS
THAT WE'LL BE HIGHLIGHTING
TODAY.
WE'VE TRIED TO RAISE THIS TO AS
HIGH A BAR AS ANY NIH STUDY.
AS LEVEL SETTING IN PURSUIT OF
KEY SCIENTIFIC AIMS, BASIC
PLATFORM STRUCTURE, THREE
PILLARS, OBSERVATION STUDIES
THAT FORM A COHORT AT DIFFERENT
LEVELS OF SCALE AND DEPTH
INCLUSIVE OF EHR DATA,
ELECTRONIC HEALTH RECORD DATA,
OBVIOUSLY AT THE LARGER SCALE
BUT ALSO CLINICAL ENROLLING
COHORTS THAT ENABLE US TO DO IN
DEPTH DEEP CLINICAL
CHARACTERIZATION OF PATIENTS
WITH PASC AS WELL AS
COMMUNITY-BASED COHORTS WHICH
PROVIDE AN INTERMEDIATE LEVEL OF
EVALUATION BUT WHERE THERE'S
POWER OF THE LONGITUDINAL
ASSESSMENT PRE-COVID AND LONG
TERM FOLLOW-UP THAT'S BUILT IN
TO THESE COHORTS AND NOW WE'RE
LAYERING IN PASC ANALYSIS.
THE OTHER KEY PILLAR IS
PATHOBIOLOGY, IN WHICH THIS IS A
GREAT OPPORTUNITY FOR BIOMARKER
DISCOVERY AND DIAGNOSTICS, AS
WELL AS CLEARLY DRIVING TOWARD
THE ETIOLOGY OF THE POST
SEQUELAE OF SARS-COV-2 INFECTION
PASC AS WELL AS TESTING SOME
EARLY HYPOTHESES OF VIRAL
PERSISTENCE OR REACTIVATION OR
OTHER IMMUNE DYSREGULATION,
ORGAN DAMAGE AND DYSFUNCTION,
AND DRILLING DOWN INTO TISSUE
PATHOBIOLOGY AND MOLECULAR
PATHWAYS.
THIRD MAJOR PILLAR IS RELATED TO
CLINICAL TRIALS, AND HERE WE'LL
OUTLINE THE VARIOUS
INTERVENTIONS BEING PLANNED,
THAT GO ACROSS THE VARIOUS
DOMAINS OF DRUG, BIOLOGICS,
DEVICES, BEHAVIORAL,
COMPLEMENTARY AND INTEGRATIVE
APPROACHES AS WELL.
AND SO WE RECOGNIZE THIS TAKES A
FULL COURT PRESS, ALL-OUT EFFORT
ACROSS MULTIPLE DISCIPLINES,
THAT'S HOW WE'VE TRIED TO SET UP
THE PLATFORM, INCLUSIVE OF THE
BROAD ARRAY OF DATA TYPES,
IMAGING, MOBILE, DIGITAL,
CLINICAL, ELECTRONIC HEALTH
RECORD AND MULTIOMIC ANALYSES,
AND IT'S ALL LEVERAGING VARIOUS
CORE ELEMENTS, WHETHER PATIENT
ENGAGEMENT CORE AND OTHER
COORDINATION CORES AND
BIOREPOSITORIES, ALL OF WHICH WE
HOPE WILL PROVIDE AN INTEGRATED
AND COHERENT EXPERIMENTAL AND
ANALYTICAL APPROACH TO THESE
DATASETS.
NEXT SLIDE PLEASE.
TOWARD THAT END, KIND OF A
BOTTOM LINE UP-FRONT THUMB NAIL
SUMMARY, OVERVIEW OF THESE THREE
PILLARS, SUFFICE IT TO SAY FOR
THE ADULT ENROLLMENT COHORT THAT
WE'VE MADE REMARKABLE PROGRESS.
I BELIEVE IN DEVELOPING THE
LARGEST MOST DIVERSE AND DEEPLY
CHARACTERIZED LONGITUDINAL
CLINICAL COHORT OF LONG COVID
PATIENTS THAT WE'RE AWARE OF IN
THE WORLD.
AND THAT'S ALL BEEN DONE
PROBABLY ENROLLING 15,000
INDIVIDUALS IN 15 MONTHS WHICH
MAY BE A NEW SPEED RECORD FOR
NIH IN DEVELOPMENT OF A COHORT
STUDY, AND THAT IS ALREADY
STARTING TO GENERATE NEW
KNOWLEDGE THAT WE'LL OUTLINE
BRIEFLY FOR YOU.
SIMILARLY, PROGRESS MADE ON THE
PATHOBIOLOGY REALM, WITH FUNDED
STUDIES THAT ARE UNDERWAY AN
COLLABORATIONS GROWING THAT ARE
DOING THE DEEPER DIVE ON
PATHOBIOLOGICAL PATHWAYS, AND
VARIOUS APPROACHES, AND
INCLUSIVE OF AN AUTOPSY SERIES
WHICH THEY HAVE ENROLLED 140 OR
SO PLUS DECEDENTS, AND ON
PARALLEL TRACKS FOR HIGH
PRIORITIES AND WORKING ALONGSIDE
PATIENTS AND PROVIDERS, EXPERTS
FROM ACROSS A VARIETY OF
DISCIPLINES, NECESSARY TO
ADDRESS THE SYNDROME AND
ESTABLISH SYNERGISTIC INDUSTRY,
COLLABORATIONS OF PUBLIC/PRIVATE
PARTNERSHIP, FACILITATED BY THE
FOUNDATION OF NIH IN MANY CASES
TO REALLY DEVELOP FIVE PLATFORM
MASTER PROTOCOLS THAT WE'LL
DETAIL AT THE END OF THE TALK
WITH ANTICIPATION THEY WILL BE
ROLLING OUT IMMINENTLY AS WE
ENTER THE THIRD AND FOURTH
QUALITYERS -- QUARTERS OF THIS
CALENDAR YEAR, CAN A SENSE OF
URGENCY TO ADDRESS SUFFERING OF
PATIENTS WITH LONG COVID.
NEXT SLIDE PLEASE.
BRIEF SKETCHES RELATED TO
ELEMENTS, FIRST STARTING WITH
OBSERVATIONAL STUDIES, AND
PARTICULARLY ELECTRONIC HEALTH
RECORD REAL WORLD DATA SORTS OF
STUDIES THAT HAVE BEEN PROLIFIC
AND WE ANTICIPATE WOULD BE
AMONGST THE FIRST OUT OF THE
BOX, AS THE OTHER ELEMENTS
PROCEEDED, INDEED GREAT PROGRESS
ANALYZING 60 MILLION RECORDS
IDENTIFYING COHORTS VIRTUALLY, 7
MILLION COVID CASES, ACROSS
DIVERSE POPULATIONS IN THIS
COUNTRY.
AND REALLY ESTABLISHING A UNIQUE
CROSS-COLLABORATION BETWEEN MANY
ELECTRONIC HEALTH RECORD
DATASETS SUCH AS N3C, PEDS NET,
ALL OF US AS WELL, THESE
ELECTRONIC HEALTH RECORD
DATASETS HAVE GREAT ADVANTAGES
AND UNDERSTANDING, INCIDENCE
PREVALENCE, RISK FACTORS OVER
TIME, AND ARE LIKELY TO BE VERY
INSTRUMENTAL IN LONG-TERM
FOLLOW-UP OF PATIENTS WITH PASC
AS WELL AS DEFINING
SUBPHENOTYPES AND OTHER
CHARACTERIZATIONS, INDEED A KEY
FIRST STEP WAS DEVELOPING A
PHENOTYPE OF PASC IN ADULTS AND
CHILDREN, PARTICULARLY USEFUL
FOR THAT UNIQUE COLLABORATION TO
TEST THOSE COMPUTABLE PHENOTYPES
ACROSS THE DIFFERENT ELECTRONIC
HEALTH RECORD PLATFORMS AS A
FURTHER CROSS-VALIDATION.
IT WAS ABLE TO DO IN ESSENCE
CLINICAL TRIAL EMULATIONS, IF
YOU WILL, VIRTUALLY, TO SORT OF
SEE EXPOSURE, FOR EXAMPLE, TO
VACCINATION, INFLUENCE THE
INCIDENCE OF PASC OR LONG COVID,
SUGGESTIVE EVIDENCE THAT
VACCINATION COULD BE PROTECTIVE
AGAINST LONG COVID, SIMILARLY
PROVIDE USEFUL PREVALENCE DATA
FOR BOTH ADULTS AND CHILDREN
HERE HIGHLIGHTING THE LOWER
LEVEL OF PREVALENCE AMONGST
CHILDREN.
ADVANCE SPECIFIC AIMS RELATED TO
RISK FACTORS, ADULTS WHERE
SEVERITY OF THE DISEASE CLEARLY
WAS A WELCOME FACTOR, ACUTE
COVID, COMORBID CONDITIONS, SUCH
AS DIABETES, FOR EXAMPLE,
OBESITY, FEMALE SEX AND
RACE/ETHNIC DISPARITIES AS WELL
ELUCIDATED FROM PUBLICATIONS
THAT HAVE BEEN YIELDED FROM THE
ELECTRONIC HEALTH RECORD
COHORTS, NOT ONLY FOR ADULTS FOR
PEDIATRICS, IT WAS THE CLINICAL
COURSE OF ACUTE COVID THAT
APPEARED TO BE PARTICULARLY
POTENT RISK FACTOR FOR
DEVELOPMENT OF LONG COVID
AMONGST CHILDREN, AND FINALLY
THESE VIRTUAL COHORTS HELPFUL IN
IDENTIFYING INCREASED RISK OF
NEW ONSET CONDITIONS AS WE
FOLLOW PATIENTS WITH LONG COVID
FURTHER OUT, AND INCLUDING
ELEMENTS SUCH AS TYPE 2 DIABETES
AND MENTAL HEALTH CONDITIONS
LIKE ANXIETY, ET CETERA.
LOOKING FOR CROSS-VALIDATION
THAT MAY BENEFIT FROM CROSS-TALK
OF THE ELEMENTS OF ReCOVer,
OBSERVATION AND EHR COHORTS TO
FORM OF INFORM AND ENHANCE EACH
OTHER.
NEXT SLIDE PLEASE.
TOWARD THAT END A FEW HIGHLIGHTS
OF NEW KNOWLEDGE BEING GENERATED
OUT OF ReCOVer.
WITH THE EHR COHORTS, THIS ONE
JUST IS ONE ILLUSTRATIVE OF
ABILITY TO TRACK THIS CASE FOLKS
WITH SARS-COV-2 INFECTION, OVER
TIME, AND THEN RECOGNIZING THAT
SORT OF EMERGENCE OF IN THIS
CASE BURST OF NEW CASES OF TYPE
2 DIABETES AND HOW THAT MIGHT
RELATE TO ACUTE PHASE OF
SARS-COV-2, WORKING THROUGH
ETIOLOGY, WHETHER COMBINATION OF
THE STRESS AND ILLNESS OF THE
COVID INFECTION, DIRECT EFFECTS
OF VIRUS ON THE VASCULATURE OR
PANCREATIC FUNCTION, AS WELL AS
INSULIN SENSITIVITY OR
RESISTANCE.
AND AGAIN THIS IS A PHENOMENON
OF CHARACTERIZING, AGAIN, NOT
ONLY COMORBID CONDITIONS
PRE-COVID BUT ACTUALLY HOW COVID
ITSELF MAY BE ALTERING GLUCOSE
METABOLISM IN WAYS THAT MIGHT
PREDISPOSE TO DIABETES BOTH IN
NEAR TERM OR PERHAPS EVEN LONG
TERM, AND CRITICAL PART OF
FOLLOWING UP THESE PATIENTS WITH
PASC AND TOWARD THAT END THIS IS
AN OPPORTUNITY TO UNDERSTAND IN
GREATER MECHANISTIC DETAIL HOW
THAT WORKS AND I MIGHT JUST
FORESHADOW SOME PATHOBIOLOGY
STUDIES ARE INDEED DOING A
DEEPER DIVE ON GLUCOSE
METABOLISM AS IS OBSERVATIONAL
STUDY TO FURTHER ELUCIDATE
MECHANISMS AND COMPLEMENT EHR
OBSERVATIONS.
NEXT SLIDE PLEASE.
EHR STUDIES ARE STARTING TO
REVEAL THINGS ABOUT OTHER
PREEXISTING CONDITIONS, THIS IS
A RECENT OBSERVATION RELATED TO
OBSTRUCTIVE SLEEP APNEA AS
POTENTIAL RISK FACTOR FOR PASC,
IN THIS CASE AGAIN SHOWING
INCREASED RISK HERE, THIS GOES
INTO DETAIL, BUT SUFFICE IT TO
SAY THAT THERE IS THAT INCREASED
RISK THAT'S QUITE EVIDENT IN THE
UNADJUSTED BUT EVEN WHEN YOU
ADJUST FOR AGE, SEX, RACE,
ETHNICITY, AND INDEED
HOSPITALIZATION STATUS WHICH IS
KNOWN TO INFLUENCE THE PASC,
STILL SEEMS TO BE AN ASSOCIATION
AND PERHAPS NOT SURPRISINGLY
GIVEN THE ROLE OF OBESITY AND
PREDISPOSING TO BOTH ACUTE COVID
SEVERITY AS WELL AS OSA
ADJUSTING FOR BMI REDUCE OR
ATTENUATED SOME OF THAT ODDS
RATIO BUT THEN ELIMINATED.
NEXT SLIDE PLEASE.
SO REALLY EHR STUDIES HAVE BEEN
PROLIFIC, ARE ALSO LOOKING AT
AND LEVERAGING DIVERSE
POPULATION FROM WHICH THEY ARE
DERIVED, AND TESTED HYPOTHESIS
THAT MANY OF US ANTICIPATED THAT
IN THE SAME WAY THAT COVID WAS
CHARACTERIZED BY RACE/ETHNICITY
DISPARITIES, DISPROPORTION
BURDEN AMONGST AFRICAN AMERICAN,
LATINO POPULATIONS, THERE,
AGAIN, APPEARS TO BE SOME OF
THAT SAME PATTERN RELATED TO
LONG COVID, AND IN PARTICULAR
CERTAIN SUBCLUSTERS OF
INVOLVEMENT THAT MAY INVOLVE THE
RESPIRATORY SYSTEM, CIRCULATORY
SYSTEMS, IN PARTICULAR
CHALLENGING THESE POPULATIONS.
AGAIN, WHERE THESE POPULATIONS
ARE KNOWN TO HAVE SOME RISK
FACTORS, PRE-COVID, IN THE SAME
AREAS AND THAT CONVERGENCE OF
THOSE RISK FACTORS AND
INFECTION.
NEXT SLIDE PLEASE.
ONE OF THE OPPORTUNITIES, AGAIN,
IS TO FURTHER DEFINE THAT
CLINICAL SPECTRUM, PARTICULARLY
SUBPHENOTYPES.
A KEY PART OF THAT WILL BE TO GO
BACK AND FORTH BETWEEN
ELECTRONIC HEALTH RECORDS THAT
HAVE STARTED TO IDENTIFY THAT
COMPUTABLE PHENOTYPE BASED ON
THE VARIABLES IN ELECTRONIC
HEALTH RECORD, BUT ONE OF THE
ADVANTAGES OF THE OBSERVATIONAL
ENROLLING COHORTS IS SHEER DEPH
OF CHARACTERIZATION IN DIRECT
VISITS, WE'RE ANTICIPATING
BETWEEN ELECTRONIC HEALTH RECORD
COHORTS AS WELL AS OBSERVATIONAL
STUDIES SHOULDN'T PROVIDE
ENLIGHTENMENT TO BOTH ENHANCING
PHENOTYPE AND CHARACTERIZING AND
TESTING HYPOTHESES IN THE
OBSERVATIONAL COHORT,
PARTICULARLY AT THE LEVEL OF
SYMPTOMS BUT AS YOU CAN IMAGINE
AS WE GET DEEPER
CHARACTERIZATION OF
OBSERVATIONAL STUDIES THAT
INVOLVE CLINICAL TESTING, SCANS
OF CTs, BRAIN MRIs, THIS CAN
BECOME A RICHER AND RICHER
DATASET AND ANALYTICAL
APPROACHES INCLUDING MACHINE
LEARNING A.I. TO SEE PATTERNS
AND SUBCLUSTERS OF SYMPTOMS THAT
HOPEFULLY WILL FURTHER
CHARACTERIZE BOTH CASE
DEFINITION AS WELL AS
SUBPHENOTYPING THAT IS ONGOING.
NEXT SLIDE.
LET ME SHIFT OVER TO THE
OBSERVATIONAL STUDIES THAT
INVOLVE OUR ENROLLING CLINICAL
COHORTS AS REAL COMPLEMENT TO
VIRTUAL ELECTRONIC HEALTH RECORD
REAL WORLD DATASETS OF COHORTS
IN WHICH THE KEY ADVANTAGE WILL
BE DEEP PHENOTYPING OF DIVERSE
PARTICIPANTS ACROSS THE LIFESPAN
AND CLINICAL CONTINUUM THAT THIS
REALLY ENTAILS.
AND SO, AGAIN, THIS HAS BEEN
MOVING VERY QUICKLY ENROLLING
POST-ACUTE PATIENTS FROM 200
SITES AROUND THE COUNTRY, AND,
AGAIN, WE'RE VERY PLEASED WITH
THE ReCOVer TEAM AND
CONSORTIA'S HARD WORK SUCH THAT
ADULT ENROLLING COHORT IS ALMOST
COMPLETE, WELL OVER 90%,
CERTAINLY AS WE ENTER Q3, WILL
BE COMPLETE, PEDIATRIC IS ABOUT
50% OF THE WAY THERE.
AND THERE WILL BE FURTHER IN
DEPTH CHARACTERIZATION THAT WILL
BE IMPORTANT MOVING FORWARD.
THIS IS ALREADY STARTING TO
YIELD NEW PUBLICATIONS, WHAT
HAVE YOU.
A KEY PART MOVING FORWARD IS
ANOTHER ELEMENT THAT IS BEING
LAUNCHED THAT INVOLVES USING
WEARABLE PERSONAL SENSOR DATA TO
FURTHER ENRICH DATASET AND
SHOULD BE VERY INFORMATIVE ABOUT
EXERCISE CAPACITY, SLEEP, OTHER
PARAMETERS THAT FULLY ENRICH OUR
UNDERSTANDING OF LONG COVID.
NEXT SLIDE PLEASE.
TO THAT END WE'RE EXCITED BY THE
MOST RECENT PUBLICATION IN JAMA
LAST WEEK OR SO, THAT REPRESENTS
SOME OF THE FIRST FRUITS OF THE
OBSERVATIONAL STUDY.
IT SHOULD BE NOTABLE,
PARTICULARLY TO ACD, THAT IT'S
QUITE A RARE THING THAT WHILE
YOU'RE DOING AN ENROLLMENT OF A
COHORT, YOUR PUBLICATION COMES
OUT THIS QUICKLY.
THIS WAS AN ENTER HIM -- INTERIM
ANALYSIS WITH 90 PARTICIPANTS,
CURRENTLY MORE, A SENSE OF
URGENCY IN PROVIDING AS MUCH
INFORMATION AND NEW KNOWLEDGE WE
COULD TO, AGAIN, ADDRESS THIS
SUFFERING OF PATIENTS WE THOUGHT
WAS IMPORTANT TO ALSO MOVE WITH
SENSE OF SURGERY GETTING
INFORMATION OUT AND INDEED THIS
FIRST PAPER STARTS TO LEVERAGE
THAT EARLY SET OF SYMPTOM
COMPLEX QUESTIONS INVOLVING OVER
200 SYMPTOMS SURVEYED, PATTERNS
STARTED TO EMERGE IN WHICH SOME
OF THE CONTOURS OF KEY DRIVERS
AND KEY DISCRIMINATING ELEMENTS
OF PASC THAT MAKE IT DISTINCT
FROM CONTROL GROUPS IN THIS, AND
YOU CAN SEE EMERGING IN THE
MODEL HERE SYMPTOMS THAT SEEM TO
HAVE A PARTICULAR DISCRIMINATIVE
POWER BETWEEN UNINFECTED
CONTROLS AND OTHERS, VERSUS
THOSE WITH PASC, AND YOU CAN SEE
LOSS OF SMELL AND TASTE RANKS
VERY HIGH IN THE SCORING SYSTEM
MODEL THAT THE INVESTIGATORS
USED.
POST EXERTIONAL MALAISE,
CHARACTERISTICS OF THOSE WITH
EXERCISE INTOLERANCE, THIS IS A
PHENOMENON COMMON IN CHRONIC
FATIGUE SYNDROME AS WELL.
AND YOU CAN SEE CHRONIC COUGH,
BRAIN FOG, PALPITATIONS, CHEST
PAIN, I WON'T DETAIL THEM ALL
BUT THE POINT IS BY
CHARACTERIZING THESE SYMPTOMS
WE'RE GETTING MUCH GREATER
UNDERSTANDING OF THE TRAJECTORY
OF SYMPTOMS AS THEY MOVE FROM
ACUTE COVID TO THE POST-ACUTE
SEQUELAE, AND THESE WERE PICKED
UP IN SIX-MONTH FOLLOW-UP,
ENRICHED BY SIZE AND DURATION OF
FOLLOW-UP AND DEEPER
CHARACTERIZATION, BUT WE
EXCITED.
IN FACT I BELIEVE THIS IS
ALREADY -- OUT A WEEK RANKS IN
FIRST PERCENTILE OF JAMA
ARTICLES IN THE LAST YEAR OR SO.
TOWARD THAT END, THE NEXT STEP
TO MOVE FROM TIER 1 ANALYSIS
THAT WAS VERY MUCH ABOUT
PATIENT-REPORTED SYMPTOMS AND
OTHER CHARACTERIZATION, TO
DEEPER CLINICAL CHARACTERIZATION
IN TIER 2 AND TIER 3 THAT WILL
INVOLVE MORE COMPLETE ANALYSIS
OF CT SCANS, MRI SCANS, BIOPSIES
IN SOME CASES, ET CETERA.
ENSURING THIS IS THE MOST DEEPLY
COMPREHENSIBLE CHARACTERIZED
COHORT OF LONG COVID THAT
EXISTS.
NEXT SLIDE PLEASE.
TOWARD THAT END, ANOTHER
OBSERVATIONAL STUDY FINDING
RELATES TO THE DIFFERENT WAVES
OF THE PANDEMIC WITH VARIANTS,
MANY OF YOU ARE AWARE OF THE
DELTA WAVE AND OMICRON WAVE, AND
THIS STUDY WAS ALREADY STARTING
TO PICK UP SOME OF THOSE
ELEMENTS AS WERE THE OTHER
COHORTS, ELECTRONIC HEALTH
RECORD AND COMMUNITY-BASED
COHORTS, SO WE ARE GETTING SOME
SENSE THAT DELTA WAVE OF THE
PANDEMIC MAY HAVE YIELDED A
HIGHER PREVALENCE OF LONG COVID,
RELATIVE TO OMICRON.
THIS IS STILL BEING SORTED OUT,
ALL THESE ARE STILL EARLY DAYS
OF ANALYSIS BUT THOSE THAT THE
INITIAL HINTS OF WHAT WE'RE
LEARNING THUS -- THOSE ARE THE
INITIAL HINTS OF WHAT WE'RE
LEARNING THUS FAR.
NEXT SLIDE PLEASE.
NOW PIVOTING AMONGST
OBSERVATIONAL STUDIES FROM EHR
AND ENROLLING COHORTS NOW BRIEF
WORD ON THE LONGITUDINAL
COMMUNITY-BASED COHORTS, THIS IS
WHERE WE'VE LEVERAGED OVER 14
EXISTING LONGITUDINAL
COMMUNITY-BASED COHORTS, SIMILAR
TO FRAMING HAM AND JACKSON HEART
STUDY, STUDY OF LATINOS, NO MAS,
REGARDS, ET CETERA, INVOLVING
OVER 50,000 ADULTS, 12,000
LEVERAGING ABCD STUDY, STUDYING
PRE-COVID, WILL FOLLOW THEM
SUBSEQUENTLY FOR THE NEXT DECADE
OR MORE, AS AN OPPORTUNITY TO
CHARACTERIZE COVID IN THESE
PATIENT POPULATIONS, LONG COVID,
LONG-TERM EFFECTS ON TRAJECTORY
OF EITHER PRE-COVID CONDITIONS
OR COMORBID CONDITIONS, A GREAT
OPPORTUNITY.
THESE STUDIES ARE UNDERWAY,
PARTICULARLY LOOKING AT
INITIALLY EFFECT OF SMOKING AND
HOSPITALIZATION ON COVID AND
ASSOCIATION WITH SLOW RECOVERY
AND POTENTIALLY PASC AS WELL.
THOSE WERE ONGOING.
AND WE LOOK FORWARD TO THEIR
POWERFUL INSIGHTS.
NEXT SLIDE PLEASE.
LET ME NOW SHIFT TO THE SECOND
PILLAR, PATHOBIOLOGY.
WE'VE ALLUDED TO SOME OF THE
ELEMENTS OF THIS WHERE THESE ARE
STUDIES OF, MOST ARE
INVESTIGATOR INITIATED, THAT
CAME THROUGH GRANTS, NOTICE OF
SPECIAL INTEREST, AND RESEARCH
OPPORTUNITY ANNOUNCEMENTS.
THEY ARE PURSUING THOSE
ETIOLOGIC FACTORS AND BIOMARKER
DISCOVERY.
NEXT SLIDE PLEASE.
AND INDEED YOU'RE SEEING VARIOUS
HYPOTHESES, AND USING A VARIETY
OF ANALYTIC APPROACHES, A LARGE
NUMBER OF IMMUNOPHENOTYPING
ANALYSES ARE GOING ON, B OR T
CELL FUNCTION, AGAIN LEVERAGING
FLOW CYTOMETRY, USING PROTEOMIC
AND HIGH-THROUGHPUTS TO GET
CYTOKINE PROFILING, PROTEOMICS,
TRANSCRIPTOMICS, METABOLOMICS,
STUDY OF MICROBIOME AS WELL, ALL
THIS IS PART OF GETTING DEEP
MOLECULAR CHARACTERIZATION OF
THE OBSERVATIONAL STUDIES AND
OTHER COHORTS.
TOWARD THAT END, WE'RE LOOKING
FORWARD TO NEW KNOWLEDGE
GENERATED WHICH WILL FURTHER
ENRICH THE OBSERVATIONAL
DATASETS AND GIVE US NEW
INSIGHTS.
NEXT SLIDE PLEASE.
ONE OF THE OTHER EXCITING
ELEMENTS IS THAT THEY START OFF
AS INVESTIGATOR-INITIATED
PROPOSALS, THEY ARE INCREASINGLY
BECOMING COLLABORATIVE AN
INTEGRATED IN THE CONSORTIUM, A
NETWORK DIAGRAM TO GIVE A TASTE
OF BREADTH IN AREAS OF STUDY
THAT GO FROM MUSCULOSKELETAL
SYSTEMS TO TESTING VIRAL
PERSISTENCE, HYPOTHESIS, AND
MULTIPLE ORGAN ANALYSES BEING
DONE AND INCLUDING SOME
COMPARATIVE WORK WITH OTHER
DISORDERS AND SYNDROMES.
AND INDEED CROSS-FERTILIZING
ACROSS DISCIPLINES AS WE GO.
NEXT SLIDE PLEASE.
FINALLY, LET ME PROVIDE YOU WITH
BRIEF UPDATE OF WHERE WE ARE
WITH CLINICAL TRIALS,
IDENTIFYING SAFE AND EFFECTIVE
PASC TREATMENT STRATEGIES, AND
AGAIN THE OBJECTIVE HERE IS TO,
AGAIN, ENGAGE COMMUNITY PATIENT
PROVIDERS THROUGHOUT THE PROCESS
AND PROTOCOL DESIGN, AND
DEFINING ENDPOINTS, AND DOING SO
IN A WAY THAT'S COHERENT AND
CONSISTENT WITH COMMON DATA
ELEMENTS AND COMMON ENDPOINTS TO
FACILITATE INTEGRATIVE SORTS OF
ANALYSES.
NEXT SLIDE PLEASE.
AND SO MANY OF YOU ARE FAMILIAR
WITH THIS PROCESS OF HOW TO
STAND UP A CLINICAL TRIAL, AND
WE RECOGNIZE THAT ALTHOUGH WE'RE
MOVING WITH SENSE OF URGENCY,
THE PROCESS IS SOMETHING THAT'S
CRITICAL FOR MAINTAINING SAFETY
AND INTEGRITY OF CLINICAL
TRIALS.
AND THESE THINGS DO INHERENTLY
TAKE TIME AND ARE OFTEN
TYPICALLY ITERATIVE, WHETHER
IT'S ASSEMBLING A
MULTI-DISCIPLINARY TEAM OF BOTH
PROVIDERS, EXPERTS, TRIALISTS,
AND BRINGING THEM ALL TOGETHER
TO WORK ON DEVELOPING PROTOCOLS
THAT CAN CAPTURE THE PLEIOTROPIC
NATURE OF PASC AND YET TEST
INTERVENTIONS, A VARIETY OF
INTERVENTIONS, ACROSS THE BOARD
AND DEVELOP PROTOCOLS AND ENSURE
THEY GO THROUGH NORMATIVE REVIEW
BODIES, SAFETY MONITORING BOARD,
INSTITUTIONAL REVIEW BOARDS.
>> GARY, I'M NOT HEARING YOU.
MAYBE IT'S JUST ME?
>> I CAN HEAR HIM.
>> I'M HEARING HIM TOO.
>> ME TOO.
>> FINE FOR ME AS WELL.
>> FINE FOR ME.
>> OKAY.
THANK YOU.
WE'LL HAVE TO WORK ON DR.
TABAK'S NEXT EXAM.
SO, YEAH, I'M WINDING UP HERE.
A NUMBER OF AND HIGH OF
HIGH-THROUGHPUT ADDICTIVE WAY,
IT'S IMPORTANT THAT WE GET THIS
NOT ONLY DONE WITH SENSE OF
URGENCY BUT DO IT RIGHT AND A
KEY PART IS BEING SURE WE HAVE
AND MAINTAIN THE PATIENT
PERSPECTIVE AT THE CENTER, THEY
ARE INVOLVED IN EVERY ASPECT,
DEFINING THE MOST IMPORTANT
SYMPTOMS, AND HOW THAT SHOULD
RELATE TO BOTH INCLUSION
CRITERIA AS WELL AS CLINICAL END
POINTS, AS WELL AS
INTERVENTIONS,
REALLY ENRICHED AND ENHANCED THE
PLATFORM AND PRODUCTS AND
PROTOCOLS THAT WE WILL BE
PROVIDING AND WE'RE ESTIMATING
THAT AS YOU KNOW Q3 IS RIGHT
AROUND THE CORNER, WE POISED TO
LAUNCH FIVE MASTER PROTOCOLS AND
INTERVENTIONS WITH QUARTER THREE
AND FOUR OF THIS YEAR.
NEXT SLIDE PLEASE.
AGAIN OUTLINES THE VARIOUS
MASTER PROTOCOLS THAT FORM
AROUND CERTAIN CLUSTERS, SOME
RELATED TO VIRAL PERSISTENCE AND
IMMUNE DYSREGULATION, ONE MASTER
PROTOCOL, IN WHICH WE WANT TO
TEST VIRAL PERSISTENCE
HYPOTHESIS WITH ANTI-VIRAL AND
OTHER SYMPTOM COMPLEXES THAT
CAME OUT OF THE OBSERVATIONAL
STUDY AND, AGAIN, INFORMED THE
CLINICAL TRIAL DESIGNS AND WHERE
THE MASTER PROTOCOLS WOULD BE
FOCUSED SINCE BRAIN FOG WAS A
KEY SYMPTOM, AUTONOMIC, SLEEP
DISORDERS, AND CARDIOPULMONARY
EXERCISE TOLERANCE AND
CHALLENGES.
ONE OF THE STRONG ELEMENTS IN
THIS PLATFORM KIND OF WAY RATHER
THAN LETTING A THOUSAND FLOWERS
BLOOM IS THAT IT'S MORE
INTEGRATIVE ACROSS THESE FIVE
MASTER PROTOCOLS WITH SHARED
ENDPOINTS, REGULATORY FRAMEWORK
THAT WE'VE PARTNERED EFFECTIVELY
WITH FDA ON TO REALLY ESTABLISH
FOR THE FIELD A REGULATORY
PATHWAY FOR DISORDER LIKE THIS
THAT LITERALLY GOES ACROSS
MULTIPLE FDA DIVISIONS OF
DISEASE AND TYPES OF
INTERVENTIONS AND TYPES OF
AGENTS USED IN THOSE
INTERVENTIONS, SO WE VERY MUCH
APPRECIATED THE COLLABORATIVE
WORK WITH FDA TO SEE HOW WE CAN
DO THIS RIGHT AND DEFINE AGENTS
THAT ARE SAFE AND EFFECTIVE FOR
PASC LONG COVID AND SO WE THINK
DEFINING THAT REGULATORY PATHWAY
HAS BEEN A CRITICAL ELEMENT OF
SETTING THIS UP AND WILL ENABLE
SHARED APPROACHES ACROSS THESE
PLATFORMS IN WHICH EACH ONE WILL
INFORM EACH OTHER.
AND WE'LL BE ABLE TO RAPIDLY
ASSESS RESPONSES, SEE WHAT
WORKS, WHAT DOESN'T, AND BECAUSE
OF ADAPTIVE NATURE ADD IN
ADDITIONAL ARMS AND
INTERVENTIONS AS WE GO AND
LEARN.
SO WE'RE EXCITED THAT THIS IS --
WE'RE POISED TO LAUNCH THESE.
NEXT SLIDE PLEASE.
FINALLY ANOTHER ELEMENT
IMPORTANT FOR ACD TO BE AWARE OF
WE'RE SHOWING DATA GENERATORS,
INTENTION TO SHARE AND
DISSEMINATE AND RELEASE THE DATA
THAT ReCOVer IS DEVELOPING
FOR THE ENTIRE COMMUNITY.
AND SO WE RECOGNIZE THAT THIS
WILL BE, WE BELIEVE, A RICH AND
NOVEL DATA SOURCE WITH NOTABLE
DATA TYPES, MOBILE, DIGITAL,
ELECTRONIC HEALTH RECORD,
MULTIOMICS, PATHOLOGY, IMAGING,
CLINICAL ASSESSMENTS.
WE'VE CREATED WITHIN A
CLOUD-BASED RESOURCE ONE THAT
WAS ALREADY EXISTING BIODATA
CATALYST THAT WOULD ENABLE
WORKSPACES UNDER CONTROLLED
ACCESS BY INVESTIGATORS FROM
OUTSIDE THE CONSORTIUM, AND
THAT'S BEING SET UP AS WE'VE
TRIED TO WRAP UP THE ENROLLMENT
OF THE COHORTS, MAKE SURE WE
HAVE CLEAN DATASETS, AND WE HAVE
THE ENVIRONMENT WHERE
INVESTIGATORS FROM OUTSIDE
CONSORTIUM CAN START TO DIVE IN
AND ANALYZE DATA AS WELL, AND
WE'RE ANTICIPATING THIS TO BE
AVAILABLE IN THIS CLOUD-BASED
RESOURCE THIS FALL.
NEXT SLIDE PLEASE.
SO I'VE TRIED TO QUICKLY CONVEY
WHERE WE ARE WITH ReCOVer,
CURRENTLY, PARTICULARLY WITH
REGARD TO OBSERVATIONAL STUDIES.
I THINK THE CONSORTIUM IS TO BE
CREDITED WITH A LOT OF
HARD-WORKING INVESTIGATORS AND
PATIENTS AND PROVIDERS IN
DEVELOPING THE LARGEST MOST
DIVERSE AND DEEPLY CHARACTERIZED
CLINICAL COHORT OF PASC
PATIENTS, ACROSS THE LIFESPAN
THAT EXISTS TO OUR AWARENESS AND
THAT ONGOING IN DEPTH CLINICAL
CHARACTERIZATION IN THE NEXT 18
MONTHS AND THAT WILL BE CRITICAL
FOR THAT IN DEPTH
CHARACTERIZATION, COMPLEMENTING
ANALYSES THUS FAR, IT WILL BE
THEN LINKED AND CROSS-VALIDATED
WITH ELECTRONIC HEALTH RECORD
STUDIES ONGOING, WE LOOK FORWARD
TO CROSS-TALK BETWEEN ENROLLING
COHORT AND EHR STUDIES.
ACROSS EHR PLATFORMS INCLUDING
ALL ALL, PCORnet AND N3C, AND
THEN FURTHER INTEGRATION OF
WEARABLE SENSOR DATA THAT MANY
OF US ARE EXCITED ABOUT, THAT
MAY GIVE US, AGAIN, ADDITIONAL
INSIGHTS PARTICULARLY WHICH
RELATE TO FATIGUE, EXERCISE
INTOLERANCE, SLEEP, AND OTHER
CHALLENGES.
AND FINALLY THE PROMISE THAT WE
THINK WILL BE THERE FOR GETTING
THAT MECHANISTIC INSIGHT WITH
DEEPER IMMUNOPHENOTYPING AND
MULTIOMIC ANALYSES AND FINALLY
CLINICAL TRIAL PROTOCOLS
LAUNCHED IN THE NEXT FEW MONTHS.
WITH THAT, THAT'S MY LAST SLIDE,
AND HAPPY TO ADDRESS ANY
RESIDUAL QUESTIONS ACD MAY HAVE.
>> THANKS, GARY.
ROBERTA, YOUR HAND WAS UP.
>> YEAH, THIS IS -- WHAT AN
INCREDIBLE TOUR DE FORCE,
CONGRATULATIONS, DR. GIBBONS, TO
THE ENTIRE ReCOVer TEAM FOR
ASTOUNDING SCIENCE ACROSS THE
BOARD.
A COUPLE QUESTIONS.
FIRST OF ALL, A BIG CONCERN IS
ONE YOU RAISED AROUND THIS ONE
LASTING SYMPTOM, TWO OF WHICH
ARE VERY RELATED TO ALZHEIMER'S
DISEASE AND WAS HEARTENED TO SEE
THE LONGITUDINAL ANALYSES IT'S
GOING TO BE POSSIBLE TO TRACK
WHETHER IN FACT LONG COVID IS A
RISK FACTOR FOR DEVELOPING
ALZHEIMER'S DISEASE AND SYMPTOMS
LIKE LOSS OF SMELL AND TASTE AND
BRAIN FOG BEING KEY AMONG THOSE.
SO THANK YOU FOR THAT.
THE OTHER QUESTIONS THAT I HAVE,
ONE, CAN YOU COMMENT ON
ReCOVer INITIATIVE AS A
MODEL AND PLATFORM FOR
RESPONDING TO FUTURE PANDEMICS,
IT SEEMS YOU HAVE SET UP A
PLATFORM THAT HAS MULTIPLE
POTENTIAL USAGES, THAT EVEN
THOUGH IT WASN'T FUNDED THROUGH
CONGRESS
>> NOT COVID FUNDS, I THINK WAS
THE STATEMENT.
>> THANK YOU.
THAT'S CORRECT.
OKAY.
OTHER COMMENTS?
>> NOT SEEING ANY BUT WE'RE
CHECKING ON THE STATUS OF OUR
NEXT PRESENTER TO SEE IF WE
MIGHT BE ABLE TO JOIN A COUPLE
MINUTES EARLY.
>> GARY, I WANT TO THANK YOU
FOR YOUR LEADERSHIP.
I'VE BEEN GIVING A HOLE IN THE
HEAD ABOUT THIS BECAUSE OF, YOU
KNOW, YOU SHARE THIS, I KNOW,
THE OBVIOUS NEED FOR DOING
THINGS AS RAPIDLY AS IS
REASONABLE, BECAUSE WE HAVE EACH
SPOKEN TO PATIENTS AND THEIR
ADVOCATES, AND WE HAVE EACH
CERTAINLY, YOU KNOW, COME TO
UNDERSTAND HOW PROFOUNDLY
AFFECTED THESE INDIVIDUALS AND
THEIR FAMILIES ARE, AND BUT YET
YOU HAVE TO BALANCE THAT AS YOU
ARTICULATED SO VERY WELL, THE
NEED TO DO THIS IN THE MOST
ROBUST WAY POSSIBLE.
AND YOU DON'T GET TOO MANY
ATTEMPTS, PARTICULARLY WITH SOMF
YOUR DATA SUGGESTS NEWER
VARIANTS ARE LESS DELETERIOUS.
>> ONLY TIME WITH TELL, THAT'S
WHERE THE LONGITUDINAL FOLLOW-UP
IS KEY AND TO DO THAT
COMPARATIVE ANALYSIS OF
INFLUENCE AT DIFFERENCE SURGES
AND MORBIDITIES AND
UNDERSTANDING ETIOLOGY BETTER.
YOU SAY WE ONLY HAD ONE SHOT AT
THIS TO TRY TO GET IT RIGHT, AND
NOW THE PLATFORM IS SUCH WITH
THE ELECTRONIC HEALTH RECORDS,
LONGITUDINAL COMMUNITY-BASED
COHORTS AS WELL AS OBSERVATIONAL
STUDIES THAT WE'RE HOPEFUL THAT
WE CAN DO SOME OF THE LONGER
TERM FOLLOW-UP TO ADDRESS THOSE
QUESTIONS YOU HAVE, AND THAT
PROBABLY WILL GIVE US INSIGHTS
TO UNFORTUNATELY FUTURE POST
VIRAL POST INFECTIOUS SYNDROMES
AS THEY OH -- EMERGE AND
HOPEFULLY WE'LL BE SMARTER AND
ABLE TO CAPTURE AT THE TIME OF
THE ACUTE INFECTION ALL THE WAY
THROUGH WHICH IS MISSING FOR A
LOT OF THE OTHER POST VIRAL
SYNDROME WORK.
>> APPLICATIONS BEYOND WHAT WE
KNOW TODAY ARE REALLY GREAT AND
UNKNOWN OPPORTUNITIES TO
LEVERAGE.
>> PROMPTED BY ROBERTA'S POINT
THERE'S SIMILARITIES WITH ISSUES
OF LIKE A.D. AND OTHER COMPLEX
DISEASES, I'M WONDERING HOW DO
YOU DISENTANGLE FURTHER AWAY
FROM THE PANDEMIC AND NUMBERS
DRAW UP, HOW DO YOU DISENTANGLE
CHRONIC DISEASES?
IT'S BEEN A PROBLEM WITH OTHER
LONG-TERM THINGS LIKE LYMES, I'M
WONDERING HOW DO YOU -- THIS
SEEMS COMPLEX AND COMPLICATED TO
ME, HOW DO YOU DEAL WITH ARE
THAT?
>> IT'S A GREAT POINT.
I DON'T THINK I HAVE ANY MAGIC
BULLETS.
THAT'S THE OTHER THING WE'RE
TESTING A NUMBER OF HYPOTHESES,
MAYBE SEVERAL ARE CORRECT AND
MAYBE THAT'S DRIVING SOME
DIFFERENT ELEMENTS OF SYMPTOM
CLUSTERS, IT MAY BE MORE THAN
ONE DISEASE, PROBABLY MULTIPLE
ETIOLOGIES, LIKE DIABETES THERE
MAY BE INTERACTIONS IN WHICH A
GIVEN CONDITION MIGHT PREDISPOSE
TO MORE SEVERE ACUTE COVID, BUT
THEN ALSO INFLUENCE RISK OF
DEVELOPING LONG COVID AND PART
OF LONG COVID MAY INVOLVE
ONGOING PERTURBATION, GLUCOSE
METABOLISM SO THAT'S ONE OF THE
ELEMENTS WHERE ELECTRONIC HEALTH
RECORD IS STARTING TO BE USEFUL
IN THAT REGARD, TO LOOK
PRE-COVID AND TRACK TRAJECTORY
OVER TIME.
BUT ALSO OUR LONGITUDINAL
COMMUNITY-BASED COHORTS,
FRAMINGHAMS OF THE WORLD,
BECAUSE THOSE HAVE IN DEPTH
CHARACTERIZESSATION OF PRE-COVID
CONDITION AND UNDERSTANDING
ENTIRE TRAJECTORY OVER TIME,
SOMETIMES 10-YEAR OR MORE
LEAD-IN AND THEY WILL HAVE AGAIN
A LONG HORIZON AS WELL.
SO TO THE POINT ABOUT
ALZHEIMER'S AND OTHER CONDITIONS
WE'LL SEE IF THERE'S AN
INTERSECTION THAT INFLUENCES
TRAJECTORIES OF EVOLVING OVER
TIME, THE COVID PERTURBOGEN, IF
YOU WILL, TO PROVIDE INSIGHTS
AND DIMENSION THE MOIST INSIGHT.
>> LIKE THE POINT ABOUT IT
BEING SUCH A UNIQUE OPPORTUNITY,
OTHER COMPLEX CHRONIC DISEASES
WE HAVEN'T HAD THE OPPORTUNITY
WITH IT HAPPENINGS AT THE ONSET
QUICKLY, AVAILABILITY.
WE DIDN'T WANT IT BUT MAKING THE
MOST OF IT.
SO VERY NICE.
THANK YOU.
>> ALL RIGHT.
I THE ReCOVer EFFORT HAS
BEEN A HUGE LIFT FOR YOU, AMY
PATTERSON AND FOLKS ON THE
ReCOVer TEAM INCLUDING
INVESTIGATORS, THANKS SO MUCH
FOR EVERYTHING THAT YOU GUYS ARE
DOING.
>> YEAH, AND THEY DO ALL THE
WORK.
I JUST DO THE TALKING.
>> .
>>WE'LL SHIFT TO THE LAST OPEN
PORTION OF THE MEETING, DR.
JULIE GERBERDING FROM THE
FOUNDATION FOR NIH, WHERE SHE'S
THE CFO, CEO LEADING THAT
ORGANIZATION, AND TELLING US
ABOUT THINGS THEY ARE FOCUSING
ON IN THE NEXT CHAPTER FOR THE
ORGANIZATION.
JULIE?
>> YOU'RE MUTED.
>> CAN YOU HEAR ME NOW?
>>YES.
>> THANK YOU FOR GIVING ME AN
OPPORTUNITY TO PRESENT TODAY AND
TO GET TO LISTEN TO GARY'S
PRESENTATION, THE ReCOVer
PROCESS IS SO FASCINATING AND SO
COMPLICATED, IT'S GREAT TO HEAR
THE PROGRESS THAT'S COME INTO
PLAY.
I HAVE THE WONDERFUL TASK OF
DESCRIBING TO YOU A LITTLE BIT
ABOUT THE FOUNDATION FOR THE
NIH, WHICH IS CONGRESSIONALLY
ORDAINED TO SUPPORT THE MISSION
OF THE NIH, REALLY BEEN IN THAT
BUSINESS FOR 25 YEARS, THIS IS
MY FIRST YEAR, HAVING COMPLETED
MY ONE-YEAR ANNIVERSARY, AS I
SAID AT THE BOARD MEETING LAST
MONTH IT'S BEEN THE HAPPIEST
PROFESSIONAL YEAR OF MY LIFE.
I LOVE WHAT I'M DOING AND THAT
THRILLS ME TO BE ABLE TO TELL
OTHERS ABOUT IT.
OBVIOUSLY, THE NIH IS IN THE
BUSINESS OF TURNING DISCOVERY
INTO HEALTH, BUT IF YOU LOOK AT
THE NEXT SLIDE THE FNIH IS PART
OF THAT PROCESS BY BUILDING
BRIDGES TO THE PRIVATE SECTOR
AND REALLY TRYING TO SUPPORT THE
NIH THROUGH OUR ABILITY TO
CONVENE IN WAYS THAT ARE
OTHERWISE VERY DIFFICULT FOR
GOVERNMENT.
THE NEXT SLIDE --
>>I'M SORRY, I JUST LEARNED
THAT -- NEVER MIND.
I'M SORRY.
WE DIDN'T HAVE A QUORUM FOR A
COUPLE MINUTES.
I JUST LEARNED RIGHT AS I SAID
IT I GOT PINGED TO SAY THE LAST
MEMBER WE NEEDED JOINED SO WE'RE
GOOD.
I'M SORRY TO INTERRUPT.
>> OKAY.
I KNOW THAT'S IMPORTANT.
NEXT SLIDE, I HAVE ARTICULATED
IN SIMPLE TERMS THE ELEVATOR
SPEECH OF WHAT THE FNIH IS ALL
ABOUT.
OUR MISSION IS REALLY TO TRY TO
ACCELERATE AND AMPLIFY THE VALUE
THAT THE NIH CREATES THROUGH ITS
RESEARCH AND SCIENTIFIC
COLLABORATIONS WITH THAT SAME
IMPACT IN MIND, BUILDING
PROJECTS TO IMPROVE HEALTH AND
HEALTH EQUALITY, ONE WAY BY
SUPPORTING COLLABORATIVE
SCIENCE, THE PRIVATE/PUBLIC
PATIENT PARTNERSHIPS, SUPPORTING
SCIENTISTS, AND MORE RECENTLY BY
BUILDING A FOCUS ON TRUST IN
SCIENCE WHICH WHEREVER WE ARE IN
THE ECOSYSTEM IS INCREASINGLY
ISSUE THAT'S REACHENING CRISIS
PROPORTIONS.
NEXT SLIDE, I'M LINKING TO YOU
TO A SHORT VIDEO TO EXPLAIN THE
WORK OF THE FNIH IN VISUAL
TERMS, IF YOU CAN LINK TO THE
VIDEO THAT WOULD BE TERRIFIC.
I'LL SEND IT TO THE BOARD AFTER
THE MEETING SO PEOPLE CAN TAKE A
LOOK.
IT'S ON OUR WEBSITE AT FNIH.ORG,
IF YOU'RE INTERESTING YOU CAN
TAKE A LOOK.
I'LL MOVE INTO A DESCRIPTION OF
SOME OF THE MAJOR WAYS THAT WE
DO OUR WORK.
ONE OF THE REAL STRENGTHS OF
FNIH IS CONVENING CAPABILITY, WE
CAN REALLY PULL PEOPLE TOGETHER
WITH THE NIH INSTITUTE
SCIENTIFIC LEADERS FROM
BASICALLY EVERY SECTOR AND
INCREASINGLY THAT ISN'T JUST IN
THE HEALTH SECTOR BUT IS
EXTENDING INTO HEALTH TECH AND
BEYOND INTO A BROADER SET OF
GLOBAL HEALTH ISSUES AS WELL.
WE FACILITATE THE DESIGN AND
DEVELOPMENT OF PARTNERSHIPS,
PARTICULARLY THOSE THAT INVOLVE
COMPLEX PARTNERS OR CHALLENGING
PRE-COMPETITIVE AREAS ESPECIALLY
OBVIOUSLY FOR INVOLVED WITH
BIOTECHNOLOGY.
WE RAISE MONEY.
THE NIH IN GENERAL CONTRIBUTES
ABOUT HALF OF THE PROJECT FUNDS,
WE RAISE THE MONEY FOR THE OTHER
HALF OF THE PROJECT FUNDS
THROUGH OUTSIDE SOURCES FROM
PHILANTHROPY, FROM THE
BIOPHARMACEUTICAL PARTNERS AND
OTHER PEOPLE WHO ARE
PARTICIPATING IN THE
PARTNERSHIPS.
ONE IS OBVIOUSLY WE NEED MUCH
BETTER SURVEILLANCE, NOT JUST
FOR THE EMERGENCE OF A THREAT
BUT FOR THE VARIANTS OF THE
PATHOGEN AS THEY EMERGE.
IN A REALLY SPEAKS TO THIS SLIDE
I JUMP OVER, THE TRACE EFFORT
MONITORING IN REAL TIME OR NEAR
REAL TIME EMERGENCE OF VARIANTS,
SHARING SEQUENCING DATA AS WELL
AS IN VITRO DATA BROADLY FROM
THROUGHOUT THE SCIENTIFIC
COMMUNITY TO STAY ON TOP OF
VARIANTS AS THEY EMERGED, TRACE
EVOLVED ALSO INTO ENVIRONMENTAL
SURVEILLANCE WHICH IS, AGAIN,
STILL ONGOING, LOOKING FOR
VARIANTS IN WATER AND OTHER
MATERIALS.
SECOND MAJOR LESSON IS REALLY
NEEDING TO INVEST NOW IN THE
PIPELINE, YOU'VE HEARD ABOUT THE
NIAID-FUNDED WORK TO REALLY
FOCUS ON FAST TRACKING
ANTI-VIRAL DEVELOPMENT FOR THE
FAMILIES OF NON-PATHOGENS SO
THIS WORK IS UNDERWAY BUT IT'S
NOT CLEAR YET HOW THE
TRANSLATIONAL CAPACITY WILL
EVOLVE SO THERE'S A SIGNIFICANT
AMOUNT OF ROOM FOR INVESTMENT
AND PARTNERSHIP, I BELIEVE, IN
PROSECUTING THESE PORTFOLIOS OF
JUST IN CASE MEDICINES SIMILAR
TO THE MODEL CEPI IS USING.
THE PRIORITIZATION AND
EVALUATION OF REPURPOSED AS WELL
AS NEW PRODUCTS WAS PART OF THE
HEROIC EFFORT I DESCRIBED BUT
THIS IS SOMETHING THAT REALLY
NEEDS TO BE PLANNED IN A
PROTOCOL MANNER TEMPLATED, IF
YOU WILL, SO THAT IT DOESN'T
HAVE TO BE INVENTED ON THE FLY
EACH TIME THERE'S A NEW
PATHOGEN.
THAT MEANS WE NEED TO HAVE
REPOSITORIES OF DATA, VIRUSES,
ASSAYS, ANIMAL MODELS, ET
CETERA, JUST BASICALLY A
PANDEMIC PLAN FOR HOW TO CONDUCT
EMERGENCY SCIENCE IN THE CONTEXT
OF AN EMERGING INFECTIOUS
DISEASE THREAT.
ON THE NEXT SLIDE I'VE DISCUSSED
THE NEED FOR BETTER COORDINATION
OF THE PRE-CLINICAL AND CLINICAL
RESEARCH.
WE PUT THIS NETWORK OF 63 SITES
UP IN RAPID PACE, BUT AS THE
RESOURCES TO SUSTAIN THAT
COORDINATED SYSTEM HAVE DECLINED
OBVIOUSLY THE NETWORKS ARE
DECLINING OR AT LEAST FALLING
BACK INTO THEIR BASAL STATE.
PART OF THE LEANING INTO THE
WORLD WE LIVE IN NOW ARE THESE
OUTBREAKS AND EMERGENCES ARE
GOING TO CONTINUE TO HAPPEN IS
TO THINK WHAT CAN BE DONE TO
MAINTAIN THE WARMTH OF THE
NETWORKS, NOT JUST IN THE U.S.
BUT GLOBALLY, BUT ALSO WHAT ARE
THE THINGS IN THE BACK OFFICE,
POLICIES, STRUCTURE CONTRACT
TEMPLATES, MASTER AGREEMENTS, ET
CETERA, THAT COULD BE PLANNED IN
EVER READY FORM SO THEY DON'T O
BE INVENTED.
WE KNOW GETTING 33 PARTNERS
AROUND LAWYERS TO COME TO
AGREEMENT IS A TEDIOUS EFFORT AT
BEST, AND CAN BE ABLE TO DO SOME
OF THIS IN ADVANCE AND HAVE
THINGS READY TO ROLL OUT WHEN
THEY ARE NEEDED WOULD SAVE TIME
AND ACCELERATE THE PROCESS.
I THINK ACTIV AND MOST OF THE
CLINICAL WORK IN THE CONTEXT OF
THE PANDEMIC REALLY DID
EVENTUALLY INTEGRATE WELL INTO
COMMUNITY CARE SETTINGS BUT NOT
FAR ENOUGH PARTICULARLY IN RURAL
AREAS, SO WE HAVE TO MAKE SURE
THAT OUR TRIAL NETWORKS ARE MORE
ININCLUSIVE THAN AT THE
BEGINNING OF THE PANDEMIC.
THIS IS A SELF SERVING POINT BUT
WE NEED A PARTNERSHIP MODEL WELL
HONED AND TONED SO THAT IT'S
READY TO ROLL WHEN WE NEED IT
FOR AN EFFECTIVE PANDEMIC
RESPONSE.
WE SAW HOW VALUABLE THAT WAS IN
WARP SPEED AS WELL.
THAT'S ACTIV IN A NUTSHELL.
AND MY THANKS TO LARRY, WHO WHEN
I CAME ON BOARD LARRY WAS REALLY
THE FORCE THAT KEPT THE TRAINS
RUNNING ON THE TRACKS AND
KEEPING ACTIV GOING AND MAKING
SURE THAT WE DIDN'T LOSE ANY
STEAM AS THINGS BEGAN TO SLOW
DOWN A BIT AND IN THE SENSE OF
THE URGENCY, SO THE WHOLE TEAM
IS HEROIC BUT LARRY, I THANK YOU
AND YOUR PATIENTS KEEPING THIS
REALLY ON TRACK.
NEXT SLIDE I'M SWITCHING GEARS
TO TALK ABOUT THE ACCELERATING
MEDICINES PARTNERSHIP, $780
MILLION PORTFOLIO EVE -- OF
PROJECTS LISTED ON THE LEFT OF
THE SCREEN.
BUT THESE PROGRAMS ARE REALLY
DESIGNED TO IDENTIFY NEW
POTENTIAL TARGETS FOR DRUG
TREATMENTS OR OTHER
INTERVENTIONS, OR TO UNDERSTAND
THE PATHWAYS AND PHYSIOLOGY OF
THE WELL AND DISEASE STATES IN
THERAPEUTIC AREAS.
THE AMAZING THING AS I BEGAN TO
STUDY THESE PROJECTS WAS FIRST
OF ALL THEIR DURABILITY, MOST OF
THESE ARE INTENSITY FUNDED
THROUGH THE PHARMACEUTICAL
INDUSTRY CONTRIBUTIONS THAT AS I
SAID IS ROUGHLY EQUAL TO WHAT
NIH IS CONTRIBUTING IN MOST
CASES, BUT THE FACT THAT THEY
SUSTAIN THE INVESTMENT FOR SUCH
LONG PERIODS OF TIME AND WHEN
THE PROJECT ENDS THEY REUP FOR
AN ADVANCED VERSION OF IT.
COMING FROM MY BACKGROUNDED A
MERCK THAT SUGGESTS PARTNERS ARE
FINDING THESE TO BE EXTREMELY
VALUABLE.
IT ISN'T EASY TO FIND THIS KIND
OF MONEY IN THE R&D SPACE WHEN
IT'S NOT DIRECTLY LINKED TO
SPECIFIC PRODUCT OR OUTCOME, TO
THAT THE COLLABORATIVE SCIENCE
GOING ON TELLS ME IT'S HIGH
VALUE SCIENCE, SO AS I WAS
COMING ON BOARD I INTERVIEWED
WITH A NUMBER OF THE COMPANIES
WHO ARE PARTNERS OF FNIH TO
REALLY UNDERSTAND WHAT IS IT
THAT YOU GET OUT OF THESE
COLLABORATIONS, AND I WAS PRETTY
IMPRESSED THAT IT'S NOT JUST THE
SPIRIT OF COLLABORATION, IT'S
REALLY THE SENSE WHEN THEY WORK
TOGETHER THEY CAN DO THINGS THAT
NO COMPANY COULD DO ALONE.
OFT EN IT HAS TO DO WITH
DATABASES SO THE QUERIES AND THE
INPUTS FROM CLINICAL TRIALS OR
PRE-COMPETITIVE WORK CAN BE
SHARED AND AGGREGATED IN WAYS
THAT DEVELOP A GREAT DEAL MORE
POWER TO IDENTIFY POTENTIAL
TARGETS OR DETERMINANTS OF
DISEASE STATES.
NEXT SLIDE I'M GOING TO
ILLUSTRATE A LITTLE BIT HOW
THESE PROGRAMS HAVE EVOLVED OVER TIME
AS THIS PROGRAM WOUND DOWN,
THE DECISION WAS MADE BY THE
PARTICIPANTS IT TOO HAD SO MUCH
MERIT THEY WANTED TO EXTEND IT.
YOU CAN SEE THE PARTNERSHIP
EXTENDED TO INCLUDE A MUCH
BROADER SWATH OF METABOLIC
DISEASES, INCLUDING KIDNEYS,
OBESITY, NASH, ET CETERA, THE
SYNDROMES THAT ARE ALL
COLLECTIVELY KNOWN AS COMMON
METABOLIC DISEASES BUT SIMILAR
APPROACH TO REALLY POOLING
INFORMATION FROM A VARIETY OF
RESOURCES
ALLOWING THAT DATA TO BE
ACCESSED AND UTILIZED BROADLY BY
NOT JUST PARTNERS BUT BY ANY
QUALIFIED INVESTIGATOR SO
ULTIMATE GOAL IS FOR ALL OF THE
DATA THAT ARE ASSEMBLED THROUGH
FNIH PARTNERSHIPS TO BE PUBLICLY
AVAILABLE TO THE APPROPRIATELY
CREDENTIALED RESEARCHERS.
NEXT SLIDE, JUST BRIEFLY
DESCRIBING THE AMP IN AUTOIMMUNE
AND IMMUNE MEDIATED DISEASE
WHICH STARTED WITH AN AMP IN
LUPUS BUT NOW EXTENDING INTO
MUCH MORE PROBING OF THE
INFLAMMASOME, THIS IS
COMPLICATED SYSTEMS BIOLOGY
APPROACH.
I HAVEN'T REALLY HAD A DEEP DIVE
INTO THE DETAILS BUT I KNOW
THERE'S GREAT DEAL OF EXCITEMENT
AND WE'VE HAD SEVERAL RECENT
PEOPLE COME FORWARD AND SAY THEY
WOULD LOVE TO BE PART OF THIS
PARTNERSHIP SO I THINK THIS IS
ALIVE AND WELL WITH A $65
MILLION INVESTMENT.
THE MOST RECENT ONE TO BE IN THE
NEWS, WHEN THE CONSORTIUM FOR
BESPOKE GENE THERAPY ANNOUNCED
THE DECISIONS ABOUT WHAT RARE
DISEASES WERE GOING TO GO INTO
THE PORTFOLIO OF CLINICAL TRIALS
FOR AAV-BASED GENE THERAPY, THIS
IS A VERY SMALL SUBSET OF THE
WORLD OF RARE DISEASES THAT HAVE
A GENETIC BASIS POTENTIALLY
AMENABLE TO GENE THERAPY BUT IT
REPRESENTS IN A SENSE PROTOTYPIC
IDEAS, RARE DISEASE INVESTMENTS
TO SUPPORT.
THOSE INCLUDE, FOR EXAMPLE,
MANUFACTURING OF GENE VECTORS,
GENE THERAPY VECTORS AND
MANUFACTURING GMP STANDARDS TO
COME TO SYSTEMIC AGREEMENT ABOUT
THAT, IT WOULD BENEFIT EVERYONE
WHO IS IN THIS SPACE.
LIKEWISE, HOW TO REALLY
PROSECUTE CLINICAL TRIALS FOR
RARE DISEASES WHEN YOU CAN'T DO
A RANDOMIZED CONTROLLED STUDY,
HAVING OPPORTUNITY TO CREATE
MORE REGULATORY CERTAINTY,
DECREASES RISK TO PEOPLE
INVESTING IN PROTOCOLS AND HELPS
SPEED THEM UP.
I LISTED THE DISEASES PART OF
THIS PORTFOLIO, AND I THINK A
BEAUTIFUL QUOTE FROM A MOTHER
WHO REALLY HAD WORKED SO HARD TO
TRY TO GET PEOPLE INTERESTED IN
HER CHILD'S DISEASE, THROUGH
BAKE SALES, ROAD RACES, GOFUNDME
TYPE EFFORTS, PEOPLE JUST
POURING THEIR HEARTS INTO TRYING
TO MOVE WHAT THEY KNOW IS
SCIENTIFICALLY POTENTIALLY
POSSIBLE TO WHERE IT'S
PRACTICALLY POSSIBLE TO DEVELOP
THERAPIES.
I HAVE THE PARTNERS CURRENTLY IN
THIS CONSORTIUM INCLUDING TEN
NIH INSTITUTES AND BRAIN
INITIATIVE, FDA IS VERY
IMPORTANT TO ALL OF THE PARTNERS
IN TERMS OF WHAT PETER MARKS IS
DOING TO SUPPORT ACCELERATED
THERAPY.
THE NON-GOVERNMENT PARTNERS HAVE
VERY LARGE PHARMA COMPANIES LIKE
PFIZER BUT ALSO VERY SMALL
COMPANIES AND A NUMBER OF
PATIENT ORGANIZATIONS.
WHAT'S TOUCHING IS MANY OF THE
PATIENT ORGANIZATIONS INVOLVED
ARE CONCERNED ABOUT DISEASES
THAT ARE NOT INCLUDED IN THE
LIST OF EIGHT DISEASES THAT ARE
GOING TO BE THE FIRST OUT OF THE
STARTING GATE, BUT JUST
RECOMMENDS, AGAIN, THAT SENTENCE
THAT LIKE COLLABORATING ALL
BOATS WILL FLOAT HIGHER AND WE
CAN GO FURTHER AND FASTER IF WE
WORK TOGETHER.
NEXT SLIDE, I'M ILLUSTRATING A
CONCEPT THAT IS ALWAYS PART OF
THE INTERSECTION WHEN NIH AND
FNIH.
BUT NOW THAT THIS IS SUCH AN
IMPORTANT PART OF THE OVERALL
PROCESS OF DRUG DEVELOPMENT WE
WANTED TO REALLY CREATE A MORE
SYSTEMIC APPROACH, SO THE WOMAN
ON THE LEFT HERE IS A WOMAN
NURSE WHO WORKED WITH ME AT
MERCK WHEN I WAS THE CHIEF
PATIENT OFFICER, TRYING TO BUILD
A COHESIVE AND COHERENT END TO
END PATIENT FOCUS AT MERCK,
SHE'S BEEN A CONSULTANT TO OUR
EFFORT TO DO THE SAME AS FNIH.
TANYA IS THE WOMAN IN THE MIDDLE
WHO IS PART OF ONE OF OUR AMP
METABOLIC AMP, NOW HAS A NEW
TITLE AS DIRECTOR OF PATIENT
ENGAGEMENT AND INNOVATION, NEXT
TO HER IS DAVID CARMEL, NEWEST
LEADER OF FNIH, AN AMAZING
ENTREPRENEUR AND HARVARD-TRAINED
AND STANFORD MBA BUSINESSMAN,
BUT ALSO HAS INDUSTRY EXPERIENCE
IN THE INVESTMENT AND INVESTOR
TO RELATIONS AREAS, MOST
RECENTLY FEATURED ON "THE TODAY
SHOW" BECAUSE HE AND HIS BROTHER
ARE WORKING COLLABORATIVELY TO
TRY TO FIND SOLUTIONS TO SPINAL
CORD INJURY IN PART BECAUSE
DAVID ATTEND A SEVERE SPINAL
CORD INJURY AT AGE 26 WHEN HE
TOOK A HEADER INTO A SANDBAR
WHILE SWIMMING, AND BECAME
PARALYZED FROM CHEST DOWN.
DAVID IS VERY MUCH COMMITTED TO
THIS CONCEPT OF PATIENT FOCUS
ACROSS OUR WORK, I WON'T GO INTO
DETAILS BUT WE'RE WORKING HARD
TO INCREASE OUR PRESENCE AND WE
DO HAVE PATIENT ENGAGEMENT AND
HAVE HIRED PATIENT AMBASSADORS
WHO ARE THERE TO HELP, HELP
OTHER PEOPLE UNDERSTAND THE
IMPORTANCE OF TRIALS AND
CLINICAL RESEARCH AND IMPORTANCE
OF IMPROVING ACCESS AND
PARTICIPATION.
NEXT SLIDE, I'M ILLUSTRATING ONE
REALLY IMPORTANT POINT,
POTENTIALLY A POINT WHERE THE
ADVISORY COMMITTEE COULD BE
HELPFUL.
THAT IS THE PLAN FOR OUR MOST
RECENT AMP, TO MOVE TOWARD THE
LAUNCH PHASE.
THIS IS THE ALS AMP, WHICH IS
SOMETHING THAT WE HAVE A GREAT
DEAL OF PASSION FOR, BUT WHEN WE
WERE THINKING ABOUT HOW TO TIME
OUR WORK I WENT BACK AND LOOKED
AT HOW WE LAUNCHED ALL OF OUR
OTHER AMPs, AND DISCOVERED
THAT ON AVERAGE IT TAKES AT
LEAST 18 MONTHS FROM THE TIME
THE IDEA IS GENERALLY ACCEPTED
AS A GOOD ONE UNTIL WE CAN GO
THROUGH ALL THE STAGES OF
DESIGNING AND RAISING MONEY AND
EXECUTING THE CONTRACTS, AND
ULTIMATELY DEVELOPING THE
RESEARCH PLAN.
FOR THE PEOPLE ON THE INDUSTRY
SIDE THIS IS TOO LONG BECAUSE
THEY OPERATE ON BUDGET CYCLES
MUCH SHORTER AND THEY NEED TO
HAVE SOMETHING TO SHOW FOR THEIR
INVESTMENTS ON A FASTER TIMELINE
THAN THIS.
SO WE ARE EXPERIMENTING WITH ALS
AMP TO SEE HOW WE CAN DO SOME
THINGS IN PARALLEL AS OPPOSED TO
IN SERIES BUT MORE IMPORTANTLY
HOW WE CAN JUMP START THE
FUNDING OF THESE PROJECTS EVEN
IF NIH ISN'T YET IN A NEW FISCAL
YEAR WHERE THEY HAVE A BUDGET OR
IF THEY HAVE A CONTINUING
RESOLUTION AND CAN'T START
THINGS NEW EASILY, WE REALLY
RECOGNIZE IMPORTANT ROLES FNIH
CAN PLAY TO JUMP START THINGS TO
ACCELERATE THEM AND GET THEM
GOING FASTER.
THAT'S HOW WE'RE OPERATING WITH
THIS PARTICULAR AMP, WORKING ON
CONTRACTUAL MODELS, TASK ORDER,
ET CETERA.
WE'RE OPTIMISTIC WE'RE GOING TO
LEARN A LOT, ON TRACK TO SHORTEN
LAUNCH TIME.
STAY TUNED.
I WANTED TO THANK LARRY AND NIH
BECAUSE CONGRESS AUTHORIZES THE
NIH TO TRANSFER CERTAIN AMOUNT
OF MONEY TO THE FNIH EACH YEAR
AND THIS IS ONE OF THE WAYS I
INTEND TO USE THOSE RESOURCES TO
HELP MOVE THE CYCLE OF THESE
PARTNERSHIP ALSO INTO A FASTER
PHASE AND SO APPRECIATE THAT
SUPPORT.
NEXT SLIDE, I'M LISTING SOME OF
THE WAYS IN WHICH WE THINK THE
RESOURCE DEVELOPMENT WILL BE
HELPFUL TO NIH AND OBVIOUSLY
FNIH, WE'RE IN THE QUIET PHASE
OF A FUNDRAISING CAMPAIGN TO
BUILD THIS CHEST OF FLEXIBLE
RESOURCES, MY GOAL NOT TO
SOLICIT RESOURCES TODAY BUT JUST
TO SAY THAT WE ARE LEARNING AS
WE GO ABOUT AND DO OUR HOMEWORK
ON THIS FINANCIAL CAMPAIGN THAT
WE ARE EXTREMELY WELL POSITIONED
TO RAISE MONEY FROM THE OUTSIDE
PARTICULARLY FROM DONOR-ADVISED
FUNDS WHERE PEOPLE WHO CARE
ABOUT BIOMEDICAL RESEARCH MOVED
THEIR MONEY INTO FUNDS WHERE
THEY CAN ITEM THE ADVISER WHERE
TO PUT THE MONEY BUT WHEN THEY
APPRECIATE THEY COULD INVEST IN
THE SITUATION THAT HAS THE NIH
WITH ITS INCREDIBLE SCIENTIFIC
CREDIBILITY, SOME OF THE BEST
ACADEMICIANS WORKING IN A
PARTICULAR THERAPEUTIC AREA, AND
HEADS OF R&D OF OUR
BIOPHARMACEUTICAL SYSTEM
CONCENTRATE IN PARTNERSHIP ON
TACKLING SOME OF THESE VEXING
PROBLEMS AND PRE-COMPETITIVE
SPACE, THEY ARE VERY EXCITED AND
WE THINK THIS IS REALLY NOT ONLY
HELPFUL TO EXPANDING THE VALUE
OF PARTNERSHIPS AND SPEEDING
THEM UP BUT ALSO IN A SENSE WILL
HELP BUILD UNDERSTANDING AND
RECOGNITION OF WHAT NIH IS AND
DOES AND PROVIDE SOME LIGHT
ON -- SHINE A BRIGHT LIGHT ON
SCIENTIFIC STARS THAT WOULD BE
PART OF THE NARRATIVE DESCRIBING
THE IMPORTANCE OF THIS WORK.
LONG TERM FROM THE STANDPOINT OF
FNIH OBVIOUSLY WE AIM TO
INCREASE OUR LONG TERM FINANCIAL
STABILITY AND FLEXIBILITY, SO WE
HOPE THAT YOU HAVE SPIRITUAL
SUPPORT FOR THIS CAMPAIGN AND
IT'S IMPORTANT TO ME THAT PEOPLE
UNDERSTAND WHY WE'RE DOING IT
BECAUSE I'VE ALSO HAD THE
EXPERIENCE WHERE PEOPLE ARE A
LITTLE BIT CONFUSED ABOUT WHY
THEY WOULD GIVE MONEY TO THE
NIH.
AND SO I'M HELPING HOPEFULLY TO
TELL THE STORY THAT THERE'S
VALUE IN SUPPORTING THE WORK OF
THE NIH AND THE COLLABORATIVE
SCIENCE AND SCIENTIFIC
DEVELOPMENT SPACES.
NEXT SLIDE, I WANTED TO SWITCH
GEARS A LITTLE BIT AND JUST SAY
THAT WHAT I'VE BEEN DESCRIBING
IS PRIMARILY ONE OF OUR
PORTFOLIO PROGRAMS BUT WE HAVE
OTHERS.
WE ALSO HAVE A PIPELINE SO THIS
JUST GIVES YOU THE FLAVOR OF
SOME OF THE OTHER ACTIVITIES
THAT WE ARE EITHER DESIGNING OR
BUILDING FUNDING FOR AT THE
PRESENT TIME FOR THIS COMING
YEAR.
AND YOU CAN SEE A VARIETY OF
DOMAINS, VERY SMALL STAKE IN
GENOMIC WORKFORCE DIVERSITY AT
NIH AND THE "ALL OF US" OF US,
SERIOUS ABOUT DOING WHAT WE CAN
TO SUPPORT SOME OF THE EFFORTS
THAT ARE WORK ON BUILDING A MORE
DIVERSE INCLUSION IN THE "ALL OF
US" AND MORE DIVERSE WORKFORCE.
I THINK THIS IS EXCITING BUT
IT'S NOT TAKING US AS FAR AS WE
WANT TO GO BECAUSE WE REALLY
WANT TO HAVE MORE GLOBAL
RELEVANCE.
I HAD A CHANCE TO MEET WITH THE
ADVISORY COMMITTEE OF THE
FOGARTY, THAT GROUP HAD SPECIFIC
IDEAS ON PLACES WHERE
PARTNERSHIP MODELS MIGHT BE
PARTICULARLY SUCCESSFUL SOY
WE'RE EXPLORING SOME OF THAT.
SICKLE CELL GENE THERAPY PROGRAM
LISTED HERE HAS ALREADY BEEN
APPROVED AND IS MOVING FORWARD
FUNDED BY THE BILL AND MELINDA
GATES FOUNDATION IS A GLOBAL
PROJECT DESIGNED TO ULTIMATELY
MAKE GENE THERAPY FOR SICKLE
CELL DISEASE AVAILABLE IN
DEVELOPING WORLD, OBVIOUSLY
THAT'S VERY LONG RUNWAY BUT AT
LEAST WE'RE GETTING A START.
BUT YOU MAY HAVE IDEAS ABOUT
OTHER AREAS WHERE YOU THINK
PARTNERSHIP MODEL WOULD BE
EFFECTIVE AND I'D LIKE TO HEAR
IF YOU HAVE ANY ANY THOUGHTS ON
THAT.
NEXT SLIDE.
WANTED TO EMPHASIZE IMPORTANCE
OF SUPPORTING SCIENTISTS.
THIS IS A SNAPSHOT OF THE BIG
PICTURE SUPPORT FOR SCIENTISTS,
THE LURIE PRIZE IS A PRESTIGIOUS
AWARD FOR RISING STARS IN
SCIENCE.
WE'RE PROUD THAT IN 2014
JENNIFER DOWDEN RECEIVED THE
PRIZE AND DEVELOPED A NOBEL
PRIZE IN LATER YEARS.
WE'VE HAD A NUMBER OF REMARKABLE
SCIENTISTS, THIS YEAR THE TWO
INDIVIDUALS WHO SHARED THE LURIE
PRIZE WERE REMARKABLE
SCIENTISTS, INCREDIBLE
SCIENTIFIC COMMUNICATORS, MADE
EVERYONE IN THE ROOM WANT TO GO
INTO THEIR FIELD OF RESEARCH.
TRAILBLAZER PRIZE IS ONE THAT'S
NEAR AND DEAR TO MY HEART, DR.
GALLIN AT THE NIH CLINICAL
CENTER IS SUCH A STRONG ADVOCATE
FOR PHYSICIAN-SCIENTISTS AND HE
JUMP STARTED THIS PRIZE FOR
CLINICIAN SCIENTISTS TO HAVE THE
KIND OF RECOGNITION THEY
DESERVE.
I'M JUST THRILLED BECAUSE
YESTERDAY I LEARNED FROM THE
PRESIDENT ELECT OF THE ASCI THAT
CLINICAL MEETINGS, YOU KNOW THEY
ARE PRESTIGIOUS AND IMPORTANT,
THEY FELL OUT OF FAVOR FOR A
WHILE BUT NOW THEY ARE PICKING
UP STEAM BUT WE'LL HAVE THE
TRAILBLAZER LECTURE ANNUALLY AT
THE CLINICAL MEETINGS, AND THAT
WILL HELP AGAIN BRING THE
NIH/FNIH PARTNERSHIP AND
ENCOURAGE NOMINATIONS OF
TALENTED RISING STARS TO BE
NOMINATED AND RECOGNIZED FOR
THEIR WORK.
SMALL WAYS OF ACKNOWLEDGING THE
CREAM OF THE CROP IN SOME SENSE,
WHAT WE'RE HAPPY ABOUT THIS YEAR
IS NUMBER OF NOMINATIONS FOR
BOTH PRIZES HAVE ALMOST DOUBLED.
SO WE'RE REALLY PICKING UP
STEAM.
WE HAVE ERUDITE JUDGES, AND WE
PROUD TO BE ABLE TO SUPPORT
THEM.
THIS IS KIND OF THE TIP OF THE
ICEBERG.
WHEN YOU WATCH THE VIDEO, IT
MENTIONS OVER THE LIFESPAN OF
THE FNIH WE'VE HAD INTERACTIONS
WITH SOME 25,000 SCIENTISTS AND
VARIOUS TRAINING PROGRAMS.
MENTORING PROGRAMS, INTERFACING
BETWEEN NIH AND OXFORD
CAMBRIDGE.
WE WISH WE COULD BE MORE HELPFUL
WITH THE POSTBAC SALARY
CHALLENGE BUT WE'LL ROLL UP OUR
SLEEVES AND ENGAGE.
MY FAVORITE TO BE LAUNCHED
PROJECT IS FROM THE GENOME
RESEARCH INSTITUTE.
AND WE INTEND TO PUT GENOMIC
SCIENCE ON A MOBILE BUS OR BUSES
THAT WILL TRAVEL TO SCHOOLS IN
UNDERRESOURCED COMMUNITIES
AROUND THE UNITED STATES, AND
LET KIDS HAVE AN EXPERIENCE IN
GENOMIC SCIENCE, A GREAT WAY TO
EXCITE KIDS AND GIVE THEM AN
IMAGINATION ABOUT SOMETHING
FARFETCHED BASED ON SCIENCE
CURRICULUM IN MANY SCHOOLS WHICH
IS CERTAINLY FAR FROM OPTIMAL
BUT ALSO I THINK IS JUST ANOTHER
WAY TO BUILD RECOGNITION OF NIH
SCIENCE AND RELEVANCE AT A
COMMUNITY LEVEL AND HOPEFULLY
WILL INTEREST PEOPLE IN
UNDERSTANDING HOW STEM SCIENCE
AND THE PIPELINE FOR STEM
SCIENCE WORKS.
I THINK WE CAN BUILD A WHOLE
CADRE OF COMMUNICATION EFFORTS
AROUND THIS SO REALLY EXCITED
ABOUT IT.
STAY TUNED.
IF I TALK TO YOU AGAIN WE'LL BE
ABLE TO REPORT ON OUR PROGRESS
THERE.
LAST THING I WANTED TO DISCUSS
BEFORE I COMPLETELY FORMAL
REMARKS IS ON THE NEXT SLIDE,
JUST REALLY TALKING ABOUT THE
THIRD PIECE OF OUR WORK THAT IS
THE MOST RECENT PIECE.
THAT IS TRYING TO UNDERSTAND
WHAT WE NEED TO DO TO HELP EARN
BACK THE TRUST IN SCIENCE THAT
HAS BEEN SO DAMAGED THE PAST FEW
YEARS.
WHEN I HAD OUR ANNUAL DINNER,
DR. COLLINS SPOKE, AND IN FRONT
OF MY BOARD AND A ROOM FULL OF
OUR WONDERFUL PARTNERS REALLY
CHALLENGED FNIH TO TAKE SOME
LEADERSHIP AND TO COMMIT TO
TRYING TO TAKE A MORE VISIBLE
POSITION ON BUILDING TRUST IN
SCIENCE.
SO, TOGETHER WITH A SMALL NUMBER
OF COLLEAGUES INCLUDING THE HEAD
OF AAAS, AND MARY WOOLY FROM
RESEARCH AMERICA, BILL NOVELLY,
FORMERLY PORTER NOVELLY PUBLIC
RELATIONS FIRM, SCHOOL OF
NURSING AT PENN, A HANDFUL OF US
SAID THERE'S SAFETY IN NUMBERS,
AND SO FAR WE'VE BEEN ABLE TO
ENLIST THE SUPPORT OF 70
ORGANIZATIONS ACROSS THE
SPECTRUM OF HEALTH AND HEALTH
CARE, PROFESSIONAL
ORGANIZATIONS, PATIENT
SOCIETIES, SO ON AND SO FORTH.
TO COME TOGETHER AND COMMIT TO
CORRECTING MISINFORMATION WHEN
WE SEE IT.
AND THEN NON-INFLAMMATORY
NON-JUDGMENTAL WAY, JUST
PROVIDING ACCESS TO APPROPRIATE
INFORMATION, AND IF WE SEE
DANGEROUS DISINFORMATION, TO
REALLY COLLECTIVELY FIND WALES
-- WAYS TO CALL THAT OUT.
PEOPLE MIGHT REGARD THAT AS
VIOLATION OF FIRST AMENDMENT BUT
I DON'T THINK THE FIRST
AMENDMENT WAS DESIGNED TO, YOU
KNOW, ENCOURAGE DISINFORMATION,
SO I'M HOPING THAT BY TAKING A
FACTUAL EVIDENCE-BASED APPROACH
TO THIS THAT WE CAN BUILD NOT
JUST A RESOURCE OF INFORMATION
BUT WE CAN COLLECTIVELY ACROSS
THE THOUSANDS OF PEOPLE NOW
INCLUDED IN THESE MEMBER
ORGANIZATIONS, THAT WE CAN
CREATE OUR OWN SOCIAL NETWORK TO
SPREAD THE FACTS FAST AND PUT
INFORMATION TO COUNTER-BALANCE
SOME OF THE NONSENSE THAT GETS
PROMULGATED SO EASILY ACROSS THE
WIRES OF OUR SOCIAL ENGAGEMENT.
NEXT SLIDE I HAVE A QUICK
ILLUSTRATION HOW SOMETHING LIKE
THIS MIGHT WORK.
IF THERE IS A MYTH THAT'S BEING
PERPETRATED, CAUSING
CONSTERNATION OR BAD DECISION
MAKING IN HEALTH TO NOT, YOU
KNOW, MAKE A JUDGMENT ABOUT WHO
IS PROMOTING IT OR WHY BUT
RATHER JUST PUT INFORMATION
ABOUT THAT PROVIDES THE ACTUAL
FACTS AS WE KNOW THEM AND
UPDATES THOSE FACTS IF THEY
CHANGE OVER TIME, ET CETERA.
SO, I'M OBVIOUSLY WELL AWARE WE
DON'T HAVE AN ANSWER TO TRUST IN
SCIENCE ISSUE, BUT OVER THE LONG
ARC OF TIME I THINK BY BUILDING
A NETWORK OF PEOPLE WHO ARE
TRUSTED AT THE COMMUNITY LEVEL
AND HAVE THE INFORMATION QUICKLY
THAT THEY NEED TO PUT THESE
MYTHS AND MISINFORMATION IN
CONTEXT, WE CAN HOPEFULLY GAIN
SOME GROUND AND REBUILD SOME OF
THE TRUST THAT HAS BEEN SO
DAMAGED.
SO WITH THAT, I WILL HAVE MY
LAST SLIDE, WHICH BASICALLY JUST
SUMMARIZES THE AMBITION THAT WE
HAVE TO REALLY BE ACCELERANT AND
AMPLIFIER OF WHAT NIH IS DOING
AND THE THREE KIND OF PILLARS OF
OUR WORK, THE FLAVOR OF WHAT
WE'RE DOING IN EACH OF THEM.
I WILL STOP NOW AND TAKE ANY
QUESTIONS OR COMMENTS THAT YOU
MIGHT HAVE.
THANK YOU FOR YOUR ATTENTION.
>> LET ME JUMP IN AND THANK YOU
FOR YOUR REMARKABLE LEADERSHIP.
YOU'RE NO LONGER A NEWBIE.
YOU'VE BEEN HERE NOW FOR A BIT.
AND I MUST SAY THE TRANSITION
WAS SEAMLESS, AND YOU BROUGHT A
RENEWED ENERGY TO THINGS BECAUSE
IT'S JUST HUMAN NATURE TO HAVE A
LITTLE BIT OF A LULL AFTER BEIG
THROUGH SUCH AN INTENSE PERIOD
OF ACTIVITY, AND YOU AND YOUR
COLLEAGUES HAVE REALLY ENSURED
THAT IS A MINI LULL AND THAT WE
MOVED RIGHT INTO, YOU KNOW,
ACTION AT A VERY GOOD PACE.
I THINK SOME OF THE INITIATIVES
THAT YOU SHARED WITH THE ACD
TODAY ARE VERY EXCITING, I THINK
THE INSTITUTES TRULY ENJOY
WORKING WITH THE FOUNDATION.
I THINK THE ACCELERATING
MEDICINES PARTNERSHIP IS SORT OF
EXHIBIT A ON THAT.
AND, YOU KNOW, RESOURCES ARE
IMPORTANT, OF COURSE, I DON'T
WANT TO MINIMIZE THAT.
FIRST I KNOW HOW HARD IT IS TO
DO THAT BUT IT GOES WAY BEYOND
MONETARY RESOURCES.
YOU SAY QUICKLY SPEAKING TO THE
EXPERTISE OR PROJECT MANAGEMENT,
THAT YOUR COLLEAGUES PROVIDE,
AND IT IS INVALUABLE.
I HAVE TO SAY, I HAVE LEARNED SO
MUCH BY WORKING WITH YOUR TEAM,
AND SO I JUST -- ON BEHALF OF
NIH I WANT TO THANK YOU
PERSONALLY AND YOUR ENTIRE TEAM
WHICH IS REALLY FIRST RATE.
SO THANK YOU.
>> THANK YOU, LARRY.
OF COURSE, ALL OF US HAVE
PROBABLY MOVED FROM ONE JOB TO
ANOTHER THROUGH THE YEARS BUT
I'VE NEVER MOVED INTO A JOB
WHERE THE ORGANIZATION I
INHERITED WAS IN SUCH GOOD
SHAPE.
I REALLY REFER TO THE WONDERFUL
JOB OF BUILDING THESE
RELATIONSHIPS AND THESE PROGRAMS
AND IT'S JUST A JOY TO BE ABLE
TO PICK UP.
I'M A VERY LUCKY WOMAN AND VERY
HAPPY PERSON TO BE DOING WHAT
I'M DOING.
>> WE'RE GLAD YOU'RE IN THE
ROLE.
AND OBVIOUSLY AS YOU ALL HEARD,
THE PARTNERSHIP THAT WE HAVE
WITH FNIH IS CRITICAL THAT A LOT
OF ONGOING WORK AT NIH.
YOU'VE SEEN THAT FROM THE
SUCCESS OF SOME OF THE PROGRAMS
LIKE ACTIV AND AMP.
OKAY.
ROBERTA, YOUR HAND IS UP.
>> YEAH, I WANT TO ECHO WHAT
DR. TABAK SAID ABOUT THE IMPACT
OF THE ACCELERATED MEDICINE
PARTNERSHIPS.
I KNOW I REALIZE YOU GET THESE
BIG REPORTS THAT ARE BROAD IN
SCOPE, JUST FROM AP SINGLE
LABORATORY THAT IT GOES FROM
BASIC TO CLINICAL SCIENCE, IN
THE ALZHEIMER'S SPACE,
ACCELERATED MEDICINES
PARTNERSHIP HAVE BEEN
TRANSFORMATIVE FOR RESEARCH
ACROSS THESE DIFFERENT DOMAINS,
AND WE USE THE ACCELERATED
MEDICINE PARTNERSHIPS IN
ALZHEIMER'S DISEASE TO TRAIN OUR
T32 PRE-DOCTORAL FELLOWS, AND
OUR NATIVE AMERICAN R25 FELLOWS.
SO -- AND OUR, YOU KNOW, ADRC
RESEARCH SCHOLARS.
SO NOT ONLY IS IT A PLATFORM FOR
GAINING INSIGHTS AND DISCOVERY,
IT'S ALSO A PLATFORM, A
LEARNING, THE DATA SCIENCE, HOW
DATA IS COLLECTED AND ARCHIVED
AND ACCESSIBLE.
IT HAS A HUGE IMPACT ACROSS THE
SPECTRUM.
THANK YOU SO VERY MUCH.
>> IT'S GREAT TO GET THAT
ENDORSEMENT.
I KNOW THE TEAM WILL APPRECIATE
THAT.
SO THANK YOU.
>> SHELLEY?
>> YOU WOULD HAVE BEEN SO MOVED
WHEN OUR R25 NATIVE AMERICAN
TRAINEES WERE CONDUCTING THEIR
RESEARCH, USING AMP-AD, AND THIS
WAS DURING COVID, DRIVING AROUD
THE NAVAJO NATION TO FIND
INTERNET TOE GIVE AN INTERNET
ACCESS, TO GIVE THEIR
PRESENTATIONS OF THEIR DATA
SCIENCE ON AMP-AD.
IT WAS A REMARKABLE EXAMPLE OF
THE POWER AND IMPACT OF THIS
RESOURCE.
SO THANK YOU.
>> I ACTUALLY KNOW THAT AREA,
AND NOT TO GO OFF SUBJECT HERE
BUT IF YOU MAP THE UNITED STATES
BY COUNTY AND LOOK AT COUNTIES
THAT HAVE HIGH VACCINATION RATES
AND COUNTIES THAT HAD LOW DEATH
RATES FROM COVID, THERE'S ALMOST
PERFECT CONCORDANCE, EXCEPT IN
THE NAVAJO NATION.
BECAUSE WHILE THEY HAD A
WONDERFUL INDIAN HEALTH SERVICE
IMMUNIZATION PROGRAM, THE
CONDITIONS WERE SO TERRIBLE IN
TERMS OF ACCESS TO OTHER HEALTH
SERVICES AND CROWDING IN THEIR
HOMES AND AVAILABILITY OF
MEDICAL RESOURCES THAT THEIR
DEATH RATES WERE REALLY HIGH
PLUS COMORBID CONDITIONS WHICH
I'M SURE GARY TALKED ABOUT, HE
DID TALK ABOUT IT IN HIS
CONVERSATION ABOUT ReCOVer,
SO IT'S WONDERFUL YOU HAVE THE
PROGRAM AND THAT YOU'RE BRINGING
SCIENCE TO THE PEOPLE IN THE
COMMUNITY WHO REALLY, REALLY
NEED ALL THE HELP WE CAN GIVE
THEM.
>> AMP-AD WAS THERE WITH THEM.
SO THANK YOU.
>> THANK YOU.
>>OKAY, SHELLI?
>> INSPIRING.
THANK YOU SO MUCH.
I'M CURIOUS, FROM PROGRAM TO
PROGRAM, HOW YOU DISPERSE THE
FUNDS, IS IT GOING THROUGH --
I'M SORRY IF I'M -- MAYBE I
COMPLETELY MISSED IT BUT IS THE
PROJECT MANAGEMENT TEAMS THAT
ARE IDENTIFYING -- DO YOU HAVE A
SEPARATE GRANT PROGRAM?
I'M SORRY.
>> HOW THESE ARE SET UP.
>> FIRST THERE'S NOT A
ONE-SIZE-FITS-ALL SO THEY VARY.
IT'S THE ACTIV THAT'S DIFFERENT
BECAUSE OF THE NATURE OF THE
PANDEMIC.
BUT WHEN A PROJECT IS PROPOSED,
IT'S FIRST APPROVED BY NIH, SO
GOES THROUGH THE PROPOSAL REVIEW
PROCESS AT NIH, AND THE NIH
BUDGET ASPECT OF THAT OPERATES
PRETTY MUCH THE WAY IT DOES FOR
ANY GRANT PROGRAM, STUDY SECTION
PROCESS, PEER REVIEW, GRANT
REVIEW, PAYMENT TO THE GRANTEES,
ET CETERA GOES THROUGH THE
NORMAL NIH MECHANISMS, WELL PEER
REVIEWED.
THE OTHER FUNDS THAT ARE RAISED
FROM THE PARTNERSHIP, SOMETIMES
FLOW INTO THAT, TO RESOURCE,
SOME OF THOSE GRANTS.
SOMETIMES THE OTHER FUNDED
RESOURCES ARE USED TO DO THINGS
LIKE BUILD THE DATA CENTER OR
IMPLEMENT SUPPORT FOR THE
BIOINFORMATICS OR
INSTRUMENTATION TECHNICIAN,
SOMETIMES, YOU KNOW, IF WE'RE
DOING SOMETHING THAT IS
AMALGAMATING DATA FROM ONGOING
CLINICAL TRIALS, IT'S IMPORTANT
TO BE ABLE TO HAVE EVERYBODY WHO
IS DOING THIS USE A FAKE EXAMPLE
LIKE OSTEOPOROSIS, EVERYBODY WHO
IS DOING OSTEOPOROSIS STUDIES
HAVE A COME OP -- COMMON
DATASET, STANDARDIZATION ACROSS
THE G.E. INSTRUMENT, HAVE TO
HAVE A MECHANISM TO BUILD
STANDARDIZATION EFFORTS.
WE PAY FOR THAT.
THERE ARE DIFFERENT WAYS THE
PRIVATE SECTOR OR OTHER
RESOURCES ARE USED BUT GENERALLY
PEOPLE AWARDED MONEY THROUGH THE
COLLABORATIVE PROCESS FROM THE
NIH SIDE RECEIVE THEIR RESOURCES
THROUGH THE USUAL NIH FUNDING
MECHANISMS, WITH THE SAME
OVERHEAD THEY WOULD NORMALLY
EXPECT.
THAT'S ONE THING WHEN WE FUND,
AND WE DO SOMETIMES FUND
ACADEMICIANS BUT OUR OVERHEAD IS
CAPPED.
WE'RE EFFICIENT BECAUSE WE DON'T
PAY HIGH INDIRECTS BUT THAT'S
NOT SO GOOD IF YOU'RE ON THE
ACADEMIC SIDE.
>> I SEE.
THANK YOU VERY MUCH.
>> I'M NOT SEEING ANY OTHER
QUESTIONS FOR JULIE.
THANK YOU, JULIE, FOR ALL THAT
YOU GUYS ARE DOING AT FNIH TO
PARTNER WITH US, AND THANKS FOR
THAT GREAT PRESENTATION.
I WILL TURN IT OVER TO LARRY.
>> THANKS, EVERYONE.
>> THANKS VERY MUCH, JULIE.
AND THANK YOU, EVERYBODY.
SO, WE'VE HAD A VERY FULL AND
VERY PRODUCTIVE DAY.
I WANT TO THANK ALL OF THE
MEMBERS OF THE ACD FOR HANGING
IN THERE WITH US.
I KNOW SOME PEOPLE HAD TO COME
IN AND OUT AND WE CERTAINLY
UNDERSTAND THAT.
BUT DO APPRECIATE THAT WE WERE
ABLE TO MAINTAIN A QUORUM AT THE
ENTIRE TIME.
AND I WANT TO THAT, I WOULD LIKO
END THE SESSION, UNTIL TOMORROW
AND SO WHAT THAT MEANS IS WE ARE
GOING TO FIGURATIVELY CLEAR THE
ROOM OF EVERYBODY BUT JUST ACD
MEMBERS, DR. SCHWETZ, DR.
CARTER, MYSELF.
EVERYBODY IS EXCUSED.
AGAIN, TO THOSE WHO SERVED ON
NATIONAL ADVISORY COUNCILS FOR
INSTITUTES AND CENTERS, THIS IS
EQUIVALENT TO THE CLOSED SESSION
THAT YOU EXPERIENCE AT YOUR
COUNCIL MEETINGS, THERE ARE A
COUPLE PROGRAMS WHERE THE ACD
SERVES AS THE COUNCIL ACROSS
PROGRAMMING SINCE THERE'S NO
OBVIOUS SINGLE HOME, WE USE THE
ACD, AND THIS WILL BE EXPLAINED
IN A FEW MOMENTS ONCE WE GO INTO
CLOSED SESSION.
SO, AGAIN, I WANT TO THANK ALL
THE MEMBERS OF THE STAFF WHO
HAVE BEEN WITH US, BUT WE'RE
GOING TO NOW GO INTO CLOSED SESSION