GOOD MORNING, EVERYONE.
I'M DR. MONICA BERTAGNOLLI,
DIRECTOR OF THE NATIONAL
INSTITUTES OF HEALTH.
WELCOME TO THE 129TH MEETING OF
THE ADVISORY COMMITTEE TO THE
DIRECTOR AND I WILL NOW GAVEL
THE MEETING IN.
AND WITH THAT, I'M GOING TO TURN
TO DR. LARRY TABAK, WHO WILL
GIVE US SOME RULES OF THE GAME
HERE.
>> THANKS VERY MUCH.
AND GOOD MORNING, EVERYBODY.
JUST TO REMIND ALL OF YOU, THIS
MEETING IS OPEN TO THE PUBLIC.
INCLUDING MEMBERS OF THE PRESS,
AND IS BEING WEBCAST.
MEETING PRESENTATIONS AND ANY
SUPPLEMENTAL MATERIALS WILL BE
POSTED ON THE ACD WEBSITE
SHORTLY AFTER THE MEETING.
THE MEETING WAS ANNOUNCED IN THE
FEDERAL REGISTER ON
NOVEMBER 4TH, 2024.
OF KNOWS, WE DID RECEIVE PUBLIC
COMMENT, WHICH ACD MEMBERS CAN
REVIEW ON THEIR SHAREFILE SITE.
ACD MEMBERS AND PRESENTERS ARE
ALL JOINING US TODAY VIA ZOOM,
AND TO CONDUCT THE MEETING BOTH
TODAY AND TOMORROW.
PLEASE RAISE YOUR HAND VIRTUALLY
VIA ZOOM RATHER THAN USING THE
CHAT TO POST QUESTIONS OR TO
MAKE A COMMENT, AND I WILL BE
MONITORING THAT AND WE'LL CALL
ON YOU.
ACD MEMBERS ARE ENCOURAGED TO
KEEP THEIR CAMERAS ON AS MUCH AS
POSSIBLE.
BUT PARTICULARLY IF YOU'RE
POSING A QUESTION OR YOU WANT TO
MAKE A COMMENT, IF THAT'S
FEASIBLE FOR YOU TO DO, PLEASE
DO TAKE ON YOUR -- TAKE YOUR
CAMERA ON, AND WITH THAT, I'LL
JUST REMIND EVERYBODY THAT IF
SOMEHOW WE 1/2 DATE NAVIGATE TC
THAT YOU FEEL YOU MIGHT HAVE A
PERCEIVED CONFLICT, JUST PLEASE
LET ME KNOW BY DIRECT CHAT AND
WE CAN PUT YOU INTO ONE OF THE
SO-CALLED WAITING ROOMS.
SO WITH THAT, I WILL TURN IT
BACK TO THE NIH DIRECTOR.
>> THANK YOU, LARRY.
WELL, WE'VE GOT A LOT TO COVER
TODAY.
SO MANY THINGS THAT WERE JUST IN
DEVELOPMENT WHEN WE LAST MET SIX
MONTHS AGO ARE NOW REALITY, SO
WE'RE GOING TO BE ABLE TO GIVE
YOU SOME GREAT PROGRESS REPORTS
ON THAT.
AS PART OF MY REPORT, I'LL ALSO
REVIEW RECENT CHANGES TO
LEADERSHIP ACROSS NIH.
AND MENTION SOME AWARDS THAT OUR
STAFF HAVE RECEIVED.
DO WE HAVE THE SLIDES UP?
I JUST WANT TO MAKE SURE THAT WE
HAVE THAT.
I'M NOT SEEING THEM.
ALL RIGHT.
GREAT.
OKAY.
SO AGAIN IN THE INITIAL PART,
REVIEW SOME CHANGES IN
LEADERSHIP.
I'M GOING TO SHARE SOME PHOTOS
FROM EVENTS THAT I'VE ATTENDED
WITH THE TEAM HERE ACROSS THE
COUNTRY SINCE WE LAST SPOKE.
THEN I'LL HAND IT OVER TO NEIL
SHAPIRO FOR A BUDGET UPDATE
FOLLOWED BY OUR LEGISLATIVE
UPDATE WITH KI KATE KLIMCZAK.
I'M GOING TO COVER VARIOUS
POLICY ISSUES AS WELL AS
PROGRESS REPORTS ON WORK WE'VE
DONE TO IMPLEMENT YOUR
RECOMMENDATIONS, THE
RECOMMENDATIONS FROM THIS
COMMITTEE.
I WILL ALSO PROVIDE SOME UPDATE
AS I'VE ALREADY MENTIONED ON
OTHER PROGRAMS AND INITIATIVES
AT NIH, INCLUDING CARE FOR
HEALTH, AND THEN WE'LL CLOSE
WITH A FEW POINTS ABOUT THE
IMPORTANCE OF BASIC RESEARCH.
NEXT SLIDE, PLEASE.
LEADERSHIP CHANGES.
FOLLOWING THE DEPARTURE OF
FORMER NIMH DIRECTOR JOSHUA
GORDON, SHELLI AVENEVOLI WAS
NAMED ACTING DIRECTOR.
SHE WAS PREVIOUSLY DEPUTY
DIRECTOR.
SHE HAS CONTRIBUTED
SIGNIFICANTLY TO SEVERAL LARGE
SCALE NIH INITIATIVES INCLUDING
THE NIMH STRATEGIC PLAN, THE
ADOLESCENT BRAIN COGNITIVE
DEVELOPMENT STUDY, HEALTHY BRAIN
AND CHILD DEVELOPMENT STUDY,
ENVIRONMENTAL INFLUENCES ON
CHILD HEALTH OUT C OUTCOME STUDE
ALL-OF-US RESEARCH PROGRAM, AND
THE UNITE EFFORT.
DEMONSTRATING, AS ALL OF OUR
LEADERS DO, A REAL EFFORT NOT
ONLY TO FOCUS ON THEIR OWN
INSTITUTE, BUT ALSO ON STRATEGIC
COORDINATION THROUGHOUT ALL OF
NIH.
SHELLI WILL CONTINUE TO SERVE IN
THIS ROLE WHILE NIH CONDUCTS A
NATIONAL SEARCH FOR A
REPLACEMENT.
ON NOVEMBER 3RD, RENATE MYLES
WAS SELECTED AS ASSOCIATE
DIRECTOR FOR COMMUNICATIONS AND
PUBLIC LIAISON AND ALSO DIRECTOR
OF OUR OFFICE OF COMMUNICATIONS
AND PUBLIC REALLY ASSON.
SHE HAS BEEN SERVING IN THIS
ROLE IN AN ACTING CAPACITY SINCE
APRIL 2021 WHILE CONTINUING TO
SERVE AS NIH'S OCPL'S DEPUTY
DIRECTOR FOR PUBLIC AFFAIRS, A
POSITION SHE'S HELD SINCE
NOVEMBER 2018.
AS DIRECTOR FOR PRINCIPAL
COMMUNICATIONS OFFICE, SHE
PROVIDES EXECUTIVE LEADERSHIP TO
ENSURE CLEAR, EFFECTIVE
COMMUNICATION WITH NIH'S DIVERSE
AUDIENCES INCLUDING STAFF, THE
SCIENTIFIC COMMUNITY,
POLICYMAKERS, INTEREST GROUPS,
AND THE PUBLIC, AND I JUST WANT
TO ADD A PERSONAL NOTE OF
GRATITUDE TO RENATE AS SHE HAS
JUST BEEN A TREMENDOUS PARTNER
FOR ME OVER THE LAST YEAR AS WE
NAVIGATED A LOT OF REALLY
IMPORTANT COMMUNICATION
CHALLENGES.
GERI DONENBERG WAS SELECTED FOR
ASSOCIATE DIRECTOR FOR AIDS
RESEARCH, PART OF DIVISION OF
PROGRAM COORDINATION, PLANNING
AND STRATEGIC INITIATIVES IN THE
NIH OFFICE OF THE DIRECTOR.
SHE JOINED NIH JUST IN OCTOBER
TO LEAD THE ADVANCEMENT AND
COORDINATION OF HIV/AIDS
RESEARCH AT NIH, WORKING CLOSELY
WITH ALL OF THE CRITICALLY
INVOLVED NIH INSTITUTES AND
CENTERS.
SHE BRINGS MORE THAN 25 YEARS OF
HIV/AIDS RESEARCH EXPERIENCE TO
THIS ROLE, AND I ALSO WANT TO
THANK BILL AND DIANA, WHO BOTH
PREVIOUSLY SERVED AS ACTING OAR
DIRECTOR UNTIL DR. DONENBERG
BEGAN IN OCTOBER.
DR. CAROLYN HUTTER HAS BEEN
NAMED DIRECTOR OF THE OFFICE OF
STRATEGIC COWARD YAITION, PART
OF THE DIVISION OF PROGRAM
COORDINATION PLANNING AND
STRATEGIC INITIATIVES IN THE
DIRECTOR'S OFFICE.
THIS OFFICE PLANS, MANAGES AND
OVERSEES ACTIVITIES FUNDED BY
THE CRITICAL NIH COMMON FUND.
DR. HUTTER BRINGS MORE THAN 20
YEARS OF EXPERIENCE IN GENETICS
AND EPIDEMIOLOGY AS WELL AS IN
MANAGING VERY LARGE RESEARCH
COLLABORATIONS.
SHE WAS PREVIOUSLY THE DIRECTOR
OF THE DIVISION OF GENOME
SCIENCES AT N HGRI.
I ALSO WANT TO THANK DR. DOUG
SHEELY, WHO'S BEEN SERVING AS
ACTING DIRECTOR SINCE THE
JANUARY 2023 RETIREMENT OF
ELIZABETH WILDER.
SO DR. MARIE BERNARD, CHIEF
OFFICER FOR SCIENTIFIC WORKFORCE
DIVERSITY, HAS BEEN TELLING
DR. TABAK AND ME FOR MORE THAN A
YEAR THAT SHE INTENDS TO RETIRE
FROM FEDERAL SERVICE ON DECEMBE.
WE WERE KIND OF HOPING SHE WAS
KIDDING, BUT IT TURNS OUT THAT
WE ARE GOING TO HAVE TO
CONGRATULATE HER ON ACHIEVING
THIS REALLY IMPORTANT NEW LIFE
TRANSITION.
SO SINCE TAKING THE ROLE IN
OCTOBER 2020, MARIE HAS MADE
TREMENDOUS PROGRESS IN BUILDING,
DISSEMINATING AND ACTING ON
EVIDENCE TO STRENGTHEN THE
SCIENTIFIC WORKFORCE THROUGH
EQUITY, INCLUSION AND SIBILITYD.
ACCESSIBILITY.
UNDER HER LEADERSHIP NIH
LAUNCHED THE 21ST CENTURY
SCHOLARS PROGRAM TO BUILD A
CULTURE TO MENTOR AND SUPPORT
NIH PROGRAM OFFICERS AND
SCIENTIFIC REVIEW OFFICERS.
MARIE ALSO LAUNCHED THE
ENGAGEMENT IN ACCESS FOR
RESEARCH ACTIVE INSTITUTIONS,
DESIGNED TO HELP INSTITUTIONS
THAT HAVE BEEN LESS ABLE TO
RECEIVE NIH FUNDING, HELP THEM
NAVIGATE FUNDING OPPORTUNITIES,
ACCESSORY SOURCES AND CONNECT
WITH ALL NIH INSTITUTES, CENTERS
AND OFFICES TO UNDERSTAND
OPPORTUNITIES.
WE THANK MARIE FOR HER
LEADERSHIP AND WISH HER THE VERY
BEST IN THIS NEXT CHAPTER.
ALL OF NIH MOURNS THE LOSS OF
DR. JOHN GALLIN, THE
LONGEST-SERVING DIRECTOR OF THE
NIH CLINICAL CENTER.
I'D LIKE TO TAKE THIS
OPPORTUNITY TO HONOR THE MEMORY
OF DR. JOHN GALLIN.
HIS ILLUSTRIOUS CAREER AT NIH IN
MORE THAN 50 YEARS IN ADDITION
TO LEADING THE CLINICAL CENTER,
WHICH HE REFERRED TO AS THE
HOUSE OF HOPE.
JOHN WAS PASSIONATE ABOUT
TRAINING THE NEXT GENERATION OF
SCIENTISTS.
AS A RESULT, HIS LEGACY LIVES
FAR BEYOND HIS TIME HERE WITH
US.
JOHN WAS A TREASURE, AND THE NIH
COMMUNITY WILL MISS HIM DEARLY.
NOW I'D LIKE TO RECOGNIZE
MEMBERS OF THE NIH COMMUNITY WHO
HAVE RECEIVED ACCOLADES FOR
THEIR WORK.
WE WERE REALLY PROUD TO ADD
THREE NAMES TO THE LIST OF NOBLE
LAUREATES WHOSE WORK HAS BEEN
SUPPORTED BY NIH.
THE 2024 NOBEL PRIZE IN
PHYSIOLOGY OR MEDICINE WAS
JOINTLY AWARDED TO VICTOR AMBROS
AND GARY RUVKUN FOR THEIR DISCO
ROOFER HE MOOF KROI RNA AND ITS
ROLE IN POST TRANSCRIPTIONAL
GENE REGULATION.
IN ADDITION, DAVID BAKER, ONE OF
THREE AWARDEES OF THE NOBEL
PRIZE IN CHEMISTRY FOR HIS WORK
IN DESIGNING NEW COMPUTATIONAL
PROTEINS IS A LONG-TIME
RECIPIENT OF NIH SUPPORT.
THIS IS ALSO JUST A WONDERFUL
TESTAMENT TO THE STRENGTH OF OUR
NIH STAFF.
HERE WE HAVE LISTED NIH STAFF
NEW MEMBERS OF THE NATIONAL
ACADEMIES.
WE CONGRATULATE THEM FOR THIS
ESTEEMED HONOR, RECOGNIZING
THEIR PROFESSIONAL ACHIEVEMENTS,
THEIR ORIGINAL RESEARCH
CONTRIBUTIONS, AND THEIR
COMMITMENT TO SERVICE.
NIAID'S CHIEF INFORMATION
OFFICER MIKE TARTAKOVSKY
RECEIVED A MERITORIOUS
PRESIDENTIAL RANK AWARD FOR HIS
INNOVATIVE LEADERSHIP IN
ADVANCING NIAID'S
CYBERINFRASTRUCTURE AND
PIONEERING INITIATIVES, LIKE THE
NIH 3D PRINT EXCHANGE, WHICH HAS
HAD A LASTING IMPACT ON GLOBAL
HEALTH RESEARCH.
AND RECENTLY FORMER NIH DIRECTOR
DR. FRANCIS COLLINS RECEIVED THE
ASSISTANT SECRETARY FOR HEALTH'S
EXCEPTIONAL SERVICE MEDALLION.
THIS AWARD IS GIVEN TO A MEMBER
OF ANY UNIFORM SERVICE OR A
CIVILIAN FOR EXCEPTIONAL
CONTRIBUTIONS TO INITIATIVES OF
THE ASSISTANT SECRETARY FOR
HEALTH.
NOW I'D LIKE TO SHARE SOME
EVENTS THAT I'VE ATTENDED WITH
MANY OF THE CONTRIBUTIONS FROM
MANY OF THE STAFF AND FACULTY
HERE AT NIH, BOTH ON AND OFF
CAMPUS SINCE WE LAST MET.
OVER THE SUMMER, I VISITED THE
DOYA NATSU HEALING CENTER IN
WYOMING ON THE WIND RIVER INDIAN
RESERVATION WITH MY UNCLE AND
INSPIRATION, DR. PIERRE.
THE CENTER PROVIDES
COMMUNITY-BASED PRACTICES TO
PEOPLE AFFECTED BY SUBSTANCE USE
DISORDERS.
IT WAS A WONDERFUL OPPORTUNITY
TO LEARN HOW COMBINING THE MOST
MODERN SCIENTIFIC APPROACHES TO
SUBSTANCE ABUSE WITH THE
TRADITIONAL CULTURAL HEALING
PRACTICES OF THE EASTERN
SHOSHONE AND NORTHERN ARAPAHO
TRIBES CONTRIBUTE POWERFUL
FORCES FOR HEALING.
IN AUGUST, NORA VOLKOW, KARINA
WALTERS, SUSAN GREGORY AND I
VISITED THE UNIVERSITY OF
OKLAHOMA.
WE TOURED OU'S CANCER CENTER AND
DISCUSSED THE MANY WAYS THAT
DATA SIGH E SCIENCE CAN REVOLUTE
HEALTH RESEARCH, PARTICULARLY
WHEN IT COMES TO OUTREACH TO SO
MANY COMMUNITIES THAT ARE LEFT
OUT OF RESEARCH AND NEED US.
WE ALSO MET WITH EXPERTS AT THE
ABSENTEE SHAWNEE TRIBE HEALTH
CENTER WHO ARE LEADING RESEARCH
TO ADDRESS OVERDOSE, SUBSTANCE
USE, AND PAIN.
THEIR WORK IS SUPPORTED BY NIH'S
NATIVE COLLECTIVE RESEARCH
EFFORT TO ENHANCE WELLNESS OR
NCRU PROGRAM.
IN SEPTEMBER, SENATOR JACK REED
VISITED THE NIH CAMPUS AND
TOURED THE NIH CLINICAL CENTER.
HE GOT TO HEAR ABOUT RECENT
FINDINGS IN RNA SEQUENCING, AS
WELL AS ADVANCES IN CHILDHOOD
CANCER RESEARCH AND
INTERNATIONAL RESEARCH.
LATER THAT DAY, I WELCOMED A NEW
GROUP OF HOUSE DEMOCRATIC
CONGRESSIONAL STAFF FOR AN
INTRODUCTION TO NIH.
MANY OF US WERE DELIGHTED TO
TAKE PART IN THIS SPECIAL EVENT
IN SEPTEMBER HONORING THE GROUND
BREAKS WORK OF DR. STEVEN A.
ROSENBERG, THE CHIEF OF THE
SURGERY BRANCH AT THE NATIONAL
CANCER INSTITUTE.
A TWO-DAY SCIENTIFIC SYMPOSIUM
CELEBRATED STEVEN'S 50 YEARS AT
NCI, AND SERVED AS A WONDERFUL
TRIBUTE TO HIS DECADES WORKING
TO ADVANCE IMMUNOTHERAPY
TREATMENT FOR PATIENT WITH
CANCER.
STEVE SERVED AS AN INSPIRATION
TO ME VERY EARLY IN MY CAREER,
AND THROUGHOUT MY ENTIRE CAREER.
WHEN I WAS AN ONCOLOGY RESIDENT
AND POSTDOCTORAL FELLOW WHEN I
FIRST BECAME AWARE OF HIS
INCREDIBLE RESULTS.
HIS DEDICATION TO HIS WORK
CONTINUES TO INSPIRE ME TODAY.
IN OCTOBER, WE WERE HONORED TO
UNVEIL A NEW PLAQUE IN THE
NATIONAL LIBRARY OF MEDICINE'S
HERB GA GARDEN COMMEMORATING THE
PARTNERSHIP BETWEEN NIH AND THE
VOICES OF OUR FATHERS LEGACY
FOUNDATION.
THIS NON-PROFIT GROUP WAS
ORGANIZED BY THE DESCENDANTS OF
BLACK MEN WHO WERE UNETHICALLY
TREATED DURING A STUDY CALLED
THE UNITED STATES PUBLIC HEALTH
SERVICE STUDY OF UNTREATED
SYPHILIS IN THE NEGRO MALE AT
TUSKEGEE AND MACON COUNTY,
ALABAMA FROM 1932 TO 1972.
WE ALL KNOW THIS AS THE INFAMOUS
TUSKEGEE STUDY.
NIH WORKED WITH THE FOUNDATION
TO LOCATE AND PRESERVE A
COLLECTION OF PHYSICAL DOCUMENTS
FROM THIS STUDY WHICH ARE NOW
HOUSED AT NLM AND NOW AVAILABLE
AS A DIGITAL COLLECTION THROUGH
THE LIBRARY'S WEBSITE, WE INTEND
FOR THIS IMPORTANT MEMORIAL
PLAQUE TO CONTINUALLY REMIND US
TO NEVER REPRODUCE MISTAKES OF
THE PAST.
IN OCTOBER I JOINED SENATOR JOHN
BOZEMAN AND CONGRESSMAN STEVE
WOMACK ON A TOUR OF THE RIVER
VALLEY AND NORTHWEST ARKANSAS.
IT WAS SO INSPIRING TO SEE HOW
THE ENTIRE COMMUNITY, ACADEMIC
INSTITUTIONS, PUBLIC HEALTH
DEPARTMENTS, HEALTHCARE
PROVIDERS, BUSINESSES AND STATE
AND FEDERAL GOVERNMENT ALL WORK
TOGETHER TO PLAY A CRITICAL ROLE
TO MAKE HEALTH BETTER FOR
EVERYONE IN THESE COMMUNITIES IN
NORTHWEST ARKANSAS.
I WAS ESPECIALLY EXCITED TO CHAT
WITH STUDENTS AT THE SPRINGDALE
HIGH SCHOOL TO SEE HOW THE WORK
THAT NIH IS DOING IS INSPIRING
THE NEXT GENERATION.
SO, NOW WITH THAT INTRODUCTION,
I'D LIKE TO HAPPE HAND THIS OVEO
NEIL SHAPIRO FOR A PRESENTATION
ON ITEMS FINANCIAL.
THERE YOU GO.
>> THANK YOU.
AND GOOD MORNING.
WE CAN GO TO THE NEXT SLIDE SET.
>> WE NEED TO CUE OF
MR. SHAPIRO'S PRESENTATION,
PLEASE.
>> THANK YOU.
OKAY.
SO CURRENTLY WHERE WE ARE IN
TERMS OF THE BUDGET, WE'RE IN
FISCAL YEAR 2025, AND THE
CURRENT CONTINUING RESOLUTION
THAT WE'RE UNDER FOR TEMPORARY
FUNDING UNTIL CONGRESS PROVIDES
FINAL APPROPRIATIONS IS
SCHEDULED TO LAST UNTIL DECEMBEM
TOMORROW.
AND WE'RE VERY HOPEFUL THAT WE
WILL SOON KNOW MORE ABOUT WHAT'S
LIKELY TO BE A CONTINUATION OF
THAT CONTINUING RESOLUTION OR
C.R. AS WE SOMETIMES CALL IT.
MOST ACCOUNTS THAT IT MAY GO
INTO MARCH, BUT WE HOPE TO KNOW
POSSIBLY TODAY OR VERY SOON WHAT
THE DETAILS WILL BE ON THAT NEXT
FUNDING ROUND, AND THEN
HOPEFULLY BY THE END OF THAT
CONTINUING RESOLUTION, WE'LL
KNOW OUR FINAL APPROPRIATIONS
FOR THIS FISCAL YEAR, WHICH
STARTED ON OCTOBER 1ST.
THE FUNDING LEVEL THAT WE'RE
UNDER NOW, BECAUSE IT'S A C.R.,
IS THE 2024 LEVEL, SO THE LEVEL
WE HAD IN A PREVIOUS YEAR THAT
ENDED SEPTEMBER 30TH.
IT'S ALSO PRO-RATED FOR THE TIME
PERIOD, SO UP TO DECEMBER 20TH,
WE HAVE APPROXIMATELY A QUARTER
OF THE AMOUNT THAT WE HAD
AVAILABLE FOR THE FULL YEAR LAST
YEAR.
THE ONE DIFFERENCE IN THAT LEVEL
IS THAT THE TYPE 1 DIABETES
FUNDING, WHICH IS CALLED
MANDATORY FUNDING, THAT GOES ON
A LITTLE DIFFERENT SCHEDULE, BUT
IT WAS EX-TENDED LAST YEAR UNTIL
DECEMBER 31ST, SO WE HAVE
ESSENTIALLY THE FIRST QUARTER'S
WORTH OF FUNDING FOR THAT THAT'S
ALREADY BEEN PROVIDED AND IT
AVAILABLE TO SPEND.
ONE DIFFERENCE THERE WAS THAT
THE LEVEL HAD TYPICALLY BEEN
$150 MILLION PER YEAR.
CONGRESS WANTED TO INCREASE THAT
TO 160, SO THE AMOUNT THEY GAVE
US, SORT OF A PRO-RATED LEVEL
BASED ON THAT NEW 160 AMOUNT
WHICH WE'RE ASSUMING WILL
CONTINUE ONCE WE GET ADDITIONAL
FUNDING FOR THE REST OF THIS
YEAR.
IN ORDER TO COME UP WITH THAT
FUNDING, THE FINAL
APPROPRIATIONS, CONGRESS IS
GOING TO NEED TO REACH AN
AGREEMENT ON OVERALL SPENDING
LEVELS AND THEN HOW TO ALLOCATE
THAT AMONG THE VARIOUS BILLS
THAT COME THROUGH THEIR
SUBCOMMITTEES, AND TO GET THE
PROGRESS DOWN TO THE FINAL
APPROPRIATIONS.
SO I WANTED TO GIVE A SENSE OF
WHAT WE'VE SEEN SO FAR FROM
CONGRESS, WHAT THE PRESIDENT'S
BUDGET INCLUDED, WHICH I
DISCUSSED AT THE LAST MEETING
AND ALSO WHAT WE'VE HEARD SO FAR
FROM THE HOUSE AND THE SENATE IN
TERMS OF THEIR REACTION AND
THEIR PROPOSALS TO GO FORWARD.
THEY WERE EACH ABLE TO INTRODUCE
A BILL, GOT THE BILL THROUGH THE
FULL COMMITTEE, AND THOSE
PROVIDED THE LEVELS THAT ARE
SHOWN HERE, THE PROGRAM LEVEL,
WHICH IS THE LARGEST MEASURE OF
NIH FUND, THAT INCLUDES BOTH
WHAT COMES OUT OF THOSE BILLS AS
WELL AS THE TYPE 1 DIABETES
FUNDING AND OTHER SOURCES OF
FUNDING, SO THAT'S A LARGER
MEASURE.
THE PRESIDENT'S BUDGET WAS
$2.73 BILLION INCREASE PROPOSE
AS YOU MAY RECALL, AND THAT
INCLUDED A MANDATORY PROPOSAL
FOR ABOUT $1.5 BILLION FOR THE
CANCER MOONSHOT TO ADVANCE THAT
BEYOND WHAT WE'VE BEEN ABLE TO
DO ALREADY.
THAT MANDATORY FUNDING HAS NOT
MOVED FORWARD IN A CONGRESSIONAL
BILL AT THIS POINT.
I ALSO WANTED TO MENTION THAT
THE CURES ACT FUNDING IS PRETTY
MUCH THE SAME ACROSS ALL THESE
DIFFERENT THAN THE PRESIDENT'S
BUDGET HOUSE OR SENATE BECAUSE
IT WAS PREVIOUSLY PROVIDED IN
THE CURES ACT THAT SET
AUTHORIZATION LEVELS THAT
CONGRESS HAS BEEN ABLE TO
PROVIDE THROUGHOUT THESE YEARS,
BUT BECAUSE OF THE NATURE OF
THAT BILL, THE FUNDING WENT UP
SOME YEARS AND IN RECENT YEARS,
IT'S COME DOWN, IT'S SCHEDULED
TO END IN ANOTHER TWO YEARS, SO
THERE'S BEEN A LARGE DROPOFF
FROM THE PEAK OF $1.0785 BILLION
DOWN IN 2023, NOW WE'RE DOWN TO
$127 MILLION, SO THAT HAS
SIGNIFICANT IMPACT ON THE
PROGRAMS THAT WERE FUNDED
THROUGH THE CURES ACT.
IN TERMS OF THE HOUSE AND THE
SENATE, THE HOUSE WAS RELATIVELY
FLAT, OVERALL LOOKING AT THE
OVERALL PICTURE, AND THAT'S
BECAUSE AS YOU CAN SEE ON THE
TABLE, THEY REDUCED FUNDING FOR
ARPA-H BY $1 BILLION FROM 1.5 TO
HALF A BILLION DOLLARS, AND THEY
INCREASED THE FUNDING FOR THE
NIH INSTITUTES AND CENTERS BY
THE SAME BILLION DOLLARS.
IT'S A LITTLE BIT LESS IN TOTAL
.92 BECAUSE OF THE EFFECT OF
THAT TYPE 1 DIABETES CHANGE THAT
I MENTIONED BEFORE.
THE SENATE, ON THE OTHER HAND,
PROVIDED AN ADDITIONAL
$1.7 BILLION, SO NOT AS MUCH AS
WE REQUESTED, BUT STILL A
GENEROUS PROPOSAL THERE.
AND WE WILL SEE WHERE WE END UP
WHEN THIS ALL SETTLES OUT.
THE NEXT SLIDE HAS A LITTLE MORE
DETAIL ON THE SPECIFICS OF WHAT
THE SENATE AND THE HOUSE DID.
THEIR BILL AS I SAID HAD A
$1.7 BILLION INCREASE.
OF THAT, $1.2 BILLION WAS
DESIGNATED AS EMERGENCY FUNDING,
SO THAT IS A TYPE OF FUNDING
THAT DOESN'T COUNT AGAINST THE
DISCRETIONARY CAPS THAT WERE SET
IN THE LAST BUDGET DEAL, SO
SOMEWHAT EASIER TO PROVIDE IF
CONGRESS IS WILLING TO DO
EMERGENCY FUNDING.
THE SENATE WAS, THE HOUSE WAS
NOT, SO THAT'S ONE OF THE
DIFFERENCES BETWEEN THE TWO
LEVELS.
IN TERMS OF THE CURES ACT
PROGRAMS I MENTIONED BEFORE, THE
SENATE PROPOSED RESTORING THEM
TO THE 2023 LEVEL.
THEY USED MOST OF THE EMERGENCY
FUNDING IN ORDER TO DO THAT.
AND THAT WOULD RE WOULD REVISE E
SPECIFIC FUNDING FOR THE CANCER
MOONSHOT.
THAT HAD $216 MILLION IN TWEP
23,2023AND IT DID NOT HAVE FUNDN
CURES IN 2024.
23 WAS THE FINAL YEAR FOR THE
CANCER MOONSHOT, AND THE SENATE
FUNDS WOULD ALSO OFFSET THE
REDUCTIONS TO THE ALL-OF-US
RESEARCH PROGRAM AND THE BRAIN
INITIATIVE.
BOTH OF THOSE HAD A COMBINATION
OF BASE FUNDING AND CURES ACT
FUNDING.
THE CANCER MOONSHOT WAS TOTALLY
CURES ACT, SO THE SENATE WAS
PROPOSING TO RESTORE THE TOTAL
LEVEL, THE CURES PLUS BASE
LEVELS, FOR ALL-OF-US AND FOR
BRAIN TO WHERE THEY WERE IN
2023.
THE SENATE INCREASES THAT I
MENTIONED, THOUGH, WERE TARGETED
NOT ONLY TO THE CURES ACT
PROGRAMS BUT TO SOME OTHERS, BUT
THERE WAS NOT A GENERAL
INCREASE.
THE INSTITUTES AND CENTERS THAT
DID NOT HAVE TARGETED INCREASES
WERE THE SAME AS IN 2024.
SO THE HOUSE BILL AS I MENTIONED
BEFORE WAS RATHER DIFFERENT THAN
THE SENATE BILL.
THE TOTAL FUNDING IN THAT BILL
WAS FLAT BASED ON THAT BILLION
DOLLAR SHIFT FROM ARPA-H.
THE CURES ACT FUNDING LEVELS
WEREN'T RESTORED, SO YOU DIDN'T
HAVE THAT BACKFILL OF THE BASE
FUNDING FOR ALL OF US FOR THE
BRAIN INITIATIVE AND THE HOUSE
ALSO INCLUDED A REORGANIZATION,
THEY HAD COORDINATED WITH THE
AUTHORIZING COMMITTEE ENERGIES
AND COMMISSIONERS, AND THAT COMD
REDUCE THE NUMBER OF INSTITUTES
AND CENTERS WITH THEIR OWN
APPROPRIATIONS WHICH IS 24 OUT
OF 27, IT WOULD REDUCE THAT
NUMBER DOWN TO 12 INSTITUTES.
SO A MUCH DIFFERENT BILL THAN
THE SENATE ONE.
SO I WANT TO TALK A LITTLE BIT
ABOUT SOME OF THESE SPECIFIC
TARGETED INITIATIVES THAT WERE
IN THE HOUSE AND THE SENATE
BILLS.
AS I MENTIONED, THAT WAS WHERE
THE FUNDING WAS GENERALLY GOING
AS OPPOSED TO ACROSS THE BOARD.
FOR NCI, THE BUDGET PROPOSED
OVER $2 BILLION INCREASE.
MUCH OF THAT WAS THE MANDATORY
FUNDING THAT I MENTIONED BEFORE.
THE HOUSE, WHILE IT DID NOT
SPECIFY FUNDING FOR THE CANCER
MOONSHOT, IT DID PROVIDE A
SIGNIFICANT INCREASE FOR NCI
FROM THOSE FUNDS THAT HAD BEEN
SHIFTED.
THE SENATE RESTORED THE
$216 MILLION THAT CAME OUT OF
THE END OF THE CURES ACT FUNDING
AS WELL AS AN ADDITIONAL
$50 MILLION THERE FOR NCI.
THE OTHER ITEMS THAT I WANTED TO
HIGHLIGHT, MENTAL HEALTH
RESEARCH, THAT WAS PROPOSED IN
THE PRESIDENT'S BUDGET, ALSO
SUPPORTED AT DIFFERENT LEVELS BY
THE HOUSE AND THE SENATE.
THEY CONTINUED TRYING TO RAMP UP
FUNDING FOR ALZHEIMER'S
RESEARCH.
THEY SUPPORTED TO
VARYING DEGREES OUR PROPOSAL TO
DOUBLE THE SIZE OF FUNDING FOR
THE OFFICE OF WOMEN'S HEALTH,
AND ALSO ON THE SENATE SIDE,
SUPPORTED OUR PROPOSAL TO
INCREASE FUNDING FOR THE
NATIONAL LIBRARY OF MEDICINE AND
MAKING IT A CENTER FOR DATA
THROUGHOUT NIH THAT WOULD BE
EXTREMELY HELPFUL.
SO JUST WANTED TO POINT THOSE
OUT TO INDICATE THAT SOME OF THE
FUNDING THAT WAS SUPPORTED IN
THE PRESIDENT'S BUDGET HAS ALSO
RECEIVED SUPPORT AT THE
INITIATIVE LEVEL FROM THE HOUSE
AND THE SENATE.
WITH THAT, I'LL HAND OFF.
>> OKAY.
THANK YOU SO MUCH, NEIL.
NOW LET'S TURN TO KATE KLIMCZAK
FOR OUR LEGISLATIVE U UPDATE.
>> GREAT.
THANK YOU.
I'M GOING TO START BY GIVING A
LITTLE BIT OF AN OVERVIEW OF
SOME OF THE CONGRESSIONAL
ENGAGEMENTS THAT THE DIRECTOR
HAS HAD AND NIH HAS HAD OVER THE
PAST YEAR, AND THEN I'LL TALK A
LITTLE BIT ABOUT THE END OF YEAR
LEGISLATIVE ACTIVITY THAT WE CAN
EXPECT TO SEE AND THEN TALK A
LITTLE BIT ABOUT THE 119TH
CONGRESS, WHICH WILL BEGIN EARLY
NEXT YEAR.
SO WE HAVE SPENT THE PAST YEAR
AND A HALF WITH DIRECTOR
BERTAGNOLLI, SPENDING A LOT OF
TIME GETTING TO KNOW MANY
MEMBERS OF CONGRESS AND
ADVOCATING FOR NIH WITH MEMBERS
OF CONGRESS AND ON THE HILL.
WE'VE HAD OVER 50 MEETINGS AND
PHONE CALLS WITH MEMBERS ON A
VARIETY OF TOPICS, NIH
PRIORITIES AND MEMBER
PRIORITIES.
WE'VE ALSO HAD NINE CAMPUS OR
DISTRICT SITE VISITS.
HERE I'VE PUT UP A PHOTO OF A
VISIT THAT WE HAD TO WEST
VIRGINIA UNIVERSITY, SENATOR
SHELLEY MOORE CAPITO HELPED
ORGANIZE THAT VISIT AND SENATOR
MANCHIN ALSO JOINED AS WELL.
THE DIRECTOR ALSO HAD TWO
CONGRESSIONAL HEARINGS THIS YEAR
AS WELL, BOTH OF THOSE HEARINGS
WERE ON THE AGENCY'S FY 25
BUDGET REQUEST.
IN ADDITION, I ALSO WANTED TO
SHARE A LITTLE BIT OF AN
OVERVIEW OF THE CONGRESSIONAL
ACTIVITY THIS YEAR.
WE'VE HAD OVER 150 BRIEFINGS FOR
MEMBERS OF CONGRESS AND THEIR
STAFF.
THESE BRIEFINGS HAVE COVERED A
RANGE OF TOPICS, NEARLY EVERY IC
HAS BEEN INVOLVED IN AT LEAST
ONE, USUALLY MANY MORE
BRIEFINGS.
WE'VE ALSO HAD OVER 150 REQUESTS
FOR TECHNICAL ASSISTANCE ON
PIECES OF LEGISLATION THAT
CONGRESSIONAL MEMBERS ARE
WORKING ON THAT RELATE TO NIH
PROGRAMS OR RESEARCH ISSUES.
WE HOSTED 10 CAMPUS VISITS, OVER
40 MEETINGS WITH NIH LEADERSHIP
ON THE HILL, AND IN TOTAL, WE'VE
HAD FIVE CONGRESSIONAL HEARINGS,
WHICH INCLUDES THE DIRECTOR'S
BUDGET HEARINGS THAT I JUST
MENTIONED.
WE'VE ALSO BEEN WORKING ON A
NUMBER OF PROACTIVE OUTREACH
EFFORTS TO SHARE MORE
INFORMATION ABOUT NIH AS AN
ORGANIZATION, OUR PROGRAMS, OUR
RESEARCH.
THIS YEAR WE STARTED HOSTING
SOMETHING CALLED LUNCH & LEARNS
FOR CONGRESSIONAL STAFF EVERY
FRIDAY.
WE'VE HAD JUST SHY OF 40 LUNCH &
LEARN BRIEFINGS.
THESE AGAIN HAVE BEEN ON A
VARIETY OF TOPICS WITH 33 OF OUR
ICs, CENTERS, OFFICES.
THE ENGAGEMENT ON THESE HAS BEEN
EXCELLENT.
WE'VE HAD OVER 515 HOUSE HEALTH
STAFFERS ATTEND, OVER 400 SENATE
HEALTH STAFFERS ATTEND.
NOW I'M GOING TO TALK A LITTLE
BIT ABOUT THE LAME DUCK SESSION.
WE HAVE JUST A COUPLE MORE WEEKS
BEFORE THE END OF THE YEAR.
THE 118TH CONGRESS IS WRAPPING
UP.
EVEN THOUGH WE ONLY HAVE A
COUPLE WEEKS, THERE HAS BEEN
SOME NEW MEMBERS JOINING THE
118TH CONGRESS THAT I JUST
WANTED TO NOTE.
THERE WERE A COUPLE HOUSE RACES,
SPECIAL AND GENERAL ELECTIONS
THAT HAPPENED IN NOVEMBER.
SO A FEW NEW MEMBERS THERE.
AND THEN ON THE SENATE SIDE, I
DID WANT TO NOTE THAT WE NOW
HAVE TWO NEW SENATORS, SENATOR
MENENDEZ FROM NEW JERSEY
RESIGNED EARLIER THIS YEAR.
THERE WAS A SPECIAL ELECTION IN
NOVEMBER, SO SENATOR ELECT ANDY
KIM FROM NEW JERSEY WAS JUST
SWORN IN LAST WEEK.
AND THEN IN CALIFORNIA, THERE
HAD BEEN A SENATOR BUTLER WHO
HAD BEEN SERVING IN THAT BUT SHE
DID NOT RUN FOR RE-ELECTION OR
IN THE SPECIAL ELECTION THAT WAS
HELD IN NOVEMBER.
SO SENATOR-ELECT ADAM SCHIFF WAS
ALSO SWORN IN ON DECEMBER 8TH.
SO THESE MEMBERS WILL JOIN,
THERE WILL BE A FEW VOTES THAT
THEY WILL PARTICIPATE IN AND
PARTICULARLY FOR THE SENATORS,
THIS MEANS THAT THEY ARE JOINING
AN EARLIER SENATE CLASS AND THIS
WILL HELP THEIR SENIORITY DOWN
THE LINE.
SO THE CONGRESS' TO DO LIST FOR
THE NEXT COUPLE OF WEEKS IS
STILL PRETTY LONG.
AS NEIL MENTIONED, ONE OF THE
TOP PRIORITIES IS FIGURING OUT
WHAT TO DO ABOUT FY 25
APPROPRIATIONS AND A NEW SHORT
TERM CONGRESSIONAL CONTINUING
RESOLUTION.
I WON'T GET INTO THAT ANY MORE,
BUT THERE ARE A FEW OTHER THINGS
ON THEIR TO DO LIST.
THEY ARE NEGOTIATING A DISASTER
SUPPLEMENTAL IN RESPONSE TO THE
RECENT HURRICANES HELENE AND
MILTON, AS WELL AS OTHER NATURAL
DISASTERS.
CONGRESS ALSO HAS TO WRAP UP THE
FY 25 NATIONAL DEFENSE
AUTHORIZATION ACT.
THIS IS THE DEFENSE
AUTHORIZATION BILL THAT IS
TYPICALLY DONE EVERY YEAR.
THE HOUSE HAS ALREADY VOTED ON
THE MEASURE AND IT IS NOW MOVING
TO THE SENATE.
IT CAN OFTEN HAVE LANGUAGE THAT
DOES TOUCH SOME OF OUR PROGRAMS
OR POLICIES, SO WE DO PAY
ATTENTION TO IT VERY CLOSELY.
CONGRESS IS ALSO WORKING ON AN
END OF YEAR HEALTH PACKAGE, SO
THIS PACKAGE WILL TYPICALLY
INCLUDE A NUMBER OF HEALTH
POLICY PIECES OF LEGISLATION,
SOME OF WHICH MAY HAVE NIH
EQUITIES BUT MANY OF OUR SISTER
AGENCIES AS WELL, SO WE ARE
TRACKING THAT.
I ALSO WANTED TO NOTE THAT ANY
OVERSIGHT INVESTIGATIONS THAT
HAVE BEEN OPENED DURING THE
118TH CONGRESS MUST WRAP UP BY
THE END OF THE YEAR.
ANY REPORT THAT COMMITTEES ARE
WORKING ON ALSO HAVE TO WRAP UP
BY THE END OF THE YEAR, THEN
FINALLY JUST WANTED TO NOTE THAT
THE FARM BILL IS STILL
OUTSTANDING.
CONGRESS IS GOING TO HAVE TO
WORK THROUGH ANOTHER EXTENSION
FOR THAT.
SO AS YOU ALL KNOW, 2024
ELECTION RESULTS,
PRESIDENT-ELECT TRUMP WILL COME
INTO OFFICE ON JANUARY 20TH.
THE 119TH CONGRESS WILL BEGIN
EARLY IN JANUARY.
THE SENATE, PREVIOUSLY DEMOCRATS
WERE IN THE MAJORITY, THAT HAS
NOW FLIPPED, REPUBLICANS WILL BE
IN THE MAJORITY, THEY WERE ABLE
TO FLIP A NUMBER OF SEATS FROM
DEMOCRAT TO REPUBLICAN IN WEST
VIRGINIA, OHIO, PENNSYLVANIA AND
MONTANA.
THE HOUSE OF REPRESENTATIVES HAD
A REPUBLICAN MAJORITY, THAT WILL
REMAIN.
SO HERE IS THE BREAKDOWN OF BOTH
THE SENATE AND THE HOUSE.
WHAT I WANTED TO ILLUSTRATE HERE
IN THIS SLIDE IS THAT THE
REPUBLICAN MAJORITIES IN BOTH
THE SENATE AND THE HOUSE ARE
VERY, VERY SLIM MAJORITIES,
PARTICULARLY IN THE HOUSE OF
REPRESENTATIVES, WHICH MEANS
THAT IN BOTH CHAMBERS, THERE
WILL LIKELY HAVE TO BE A LOT OF
BIPARTISAN NEGOTIATION TO MOVE
LEGISLATION THROUGH NEXT YEAR.
NOW I'M GOING TO TALK A LITTLE
BIT ABOUT CONGRESSIONAL
LEADERSHIP.
MUCH HAS STAYED THE SAME ACROSS
THE TWO CHAMBERS AND THE TWO
PARTIES, BUT THERE HAVE BEEN
SOME CHANGES.
I WANT TO MAKE SURE I NOTE.
SO WE'LL START IN THE HOUSE.
SO IN THE 119TH CONGRESS, IT IS
EXPECTED THAT CURRENT SPEAKER
MIKE JOHNSON WILL ALSO -- WILL
CONTINUE TO BE SPEAKER IN THE
119TH CONGRESS.
HE WILL -- THE OFFICIAL VOTE
WILL HAPPEN EARLY NEXT YEAR.
THE NUMBER TWO IN THE HOUSE WILL
CONTINUE TO BE STEVE SCALISE,
ALSO OF LOUISIANA, AND THEN
MAJORITY WHIP WILL BE TOM EMMER.
TWO NEW LEADERSHIP -- THERE ARE
TWO CHANGES TO REPUBLICAN
LEADERSHIP.
LISA MCCLAIN WILL NOW BE
CONFERENCE CHAIR AND KEVIN HERN
WILL BE THE POLICY COMMITTEE
CHAIR.
ON THE DEMOCRATIC SIDE, THE
LEADERSHIP TEAM IS BROADLY THE
SAME.
HAKEEM JEFFRIES OF NEW YORK WILL
CONTINUE TO BE MINORITY LEADER,
KATHERINE CLARKE WILL BE THE
WHRIP, PETE AGUILAR WILL BE
CAUCUS CHAIR AND DEBBIE DINGELL
IS CHAIR OF THE POLICY AND
COMMUNICATIONS COMMITTEE.
IN THE SENATE, AS I NOTED,
REPUBLICANS ARE NOW MOVING INTO
THE MAJORITY.
JUST A COUPLE WEEKS AGO, JOHN
THUNE OF SOUTH DAKOTA WAS
ELECTED AS THE NEW MAJORITY
LEADER.
HE IS TAKING OVER FOR MITCH
MCCONNELL, WHO WILL REMAIN IN
THE SENATE AND FINISH UP HIS
TERM, BUT ANNOUNCED EARLIER THIS
YEAR THAT HE WAS STEPPING DOWN
FROM HIS LEADERSHIP POSITION.
AS YOU MAY KNOW, MITCH
MCCONNELL, KENTUCKY, HAS BEEN
THE REPUBLICAN MAJORITY -- HAS
BEEN THE REPUBLICAN LEADER FOR
MANY, MANY YEARS, SO THIS IS A
VERY SIGNIFICANT CHANGE IN
REPUBLICAN LEADERSHIP.
JOHN BARRASSO OF WI WYOMING WILL
NOW BE THE MAJORITY WHIP, TOM
COTTON WILL BE CONFERENCE CHAIR
AND SHELLEY MOORE CAPITO WILL
SERVE AS REPUBLICAN POLICY
COMMITTEE CHAIR.
ON THE DREAM TICK DEMOCRATIC SK
SCHUMER WILL NOW SERVE AS
MINORITY LEADER, DICK DURBIN AS
MINORITY WHIP AND AMY KLOBUCHAR
AS POLICY AND COMMUNICATIONS
HEAD FOR DEMOCRATIC MINORITY.
NOW I'M GOING TO TALK A LITTLE
ABOUT COMMITTEE LEADERSHIP
CHANGES.
WE HAVE SOME INFORMATION ABOUT
COMMITTEES THOUGH THERE ARE SOME
POSTS THAT ARE STILL BEING
DETERMINED.
SO AS A REMINDER, THE PRIMARY
COMMITTEES THAT RELATE TO NIH
ARE THE AUTHORIZING COMMITTEES,
SO IN THE HOUSE, THAT IS THE
HOUSE ENERGY AND COMMERCE
COMMITTEE.
UNDERNEATH THAT COMMITTEE, THERE
ARE TWO SUBCOMMITTEES THAT WE
PAY PARTICULAR ATTENTION TO.
THE HEALTH SUBCOMMITTEE AND THEN
THE OVERSIGHT AND INVESTIGATIONS
SUBCOMMITTEE.
ON THE SENATE SIDE, IT IS THE
SENATE HEALTH, EDUCATION, LABOR
AND PENSIONS COMMITTEE.
THESE COMMITTEES ARE RESPONSIBLE
FOR DRAFTING THE AUTHORIZING
LEGISLATION THAT GIVES US OUR
POLICY AND OVERSIGHT DIRECTION.
THE OTHER COMMITTEES OF
IMPORTANCE ARE THE
APPROPRIATIONS COMMITTEES, HOUSE
AND SENATE, AND THE RELEVANT
SUBCOMMITTEE IS LABOR, HEALTH
AND HUMAN SERVICES AND
EDUCATION.
FOR ENERGY AND COMMERCE ON THE
HOUSE SIDE, THE CURRENT CHAIR,
CATHY MA MCMORRIS RODGERS, IS
RETIRING THE END OF THIS YEAR.
JUST EARLIER THIS WEEK,
REPRESENTATIVE BRETT GUTHRIE OF
KENTUCKY WAS ELECTED AS THE NEW
INCOMING CHAIR NEXT YEAR.
HE HAD PREVIOUSLY SERVED AS
CHAIR OF THE HEALTH SUBCOMMITTEE
ON THE DEMOCRATIC SIDE,
REPRESENTATIVE FRANK PALLONE OF
NEW JERSEY WILL CONTINUE TO
SERVE AS THE RANKING MEMBER.
AND THEN IN THE SENATE, SENATOR
BILL CASSIDY HAD BEEN SERVING AS
RANKING MEMBER.
HE WILL NOW BE CHAIR OF HEALTH,
AND THE CURRENT CHAIR, SENATOR
BERNIE SANDERS OF VER MONTH, HEE
WILL NOW BE RANKING MEMBER.
THEY WILL SWAP THERE.
ON THE HOUSE SIDE THERE WILL BE
GENERALLY SPEAKING CONTINUITY ON
THE APPROPRIATION SIDE.
THE FULL APPROPRIATIONS
COMMITTEE CHAIR, TOM COLE, WILL
CONTINUE TO SERVE IN THAT ROLE
AND ROSA DELAURO OF CONNECTICUT
WILL CONTINUE TO SERVE IN THAT
ROLE.
ON THE SENATE SIDE, WE WILL
CONTINUE TO HAVE SENATOR PATTI
MURRAY OF WASHINGTON SERVE AS
THE TOP DEMOCRAT.
SHE WILL BE VICE CHAIR AND THEN
SUSAN COLLINS OF MAINE WILL BE
TAKING OVER AS CHAIR OF THE FULL
APPROPRIATIONS COMMITTEE.
LOOKING AHEAD TO THE 119TH
CONGRESS, THE CONGRESSIONAL
CALENDARS HAVE BEEN POSTED FOR
BOTH THE SENATE AND THE HOUSE.
I JUST WANTED TO NOTE THAT THE
SENATE SCHEDULE IS A
PARTICULARLY AGGRESSIVE
SCHEDULE.
THEY ARE SCHEDULED TO BE IN 180
DAYS, WHICH IS MORE THAN THEY
HAD BEEN IN THE PREVIOUS FEW
YEARS.
THE MAJORITY LEADER, JOHN THUNE,
HAS SAID THAT THE SENATE WILL BE
WORKING OVERTIME IN JANUARY,
FEBRUARY, MARCH, TO CHURN
THROUGH A NUMBER OF NOMINATIONS
AND OTHER TRUMP ADMINISTRATION
PRIORITIES.
THE HOUSE WILL BE SCHEDULED --
IS SCHEDULED TO BE IN ABOUT 136
DAYS.
SO ONCE ALL THE MEMBERS ARE
SWORN IN AND THE 119TH SESSION
GETS GOING, REPUBLICAN LEADERS,
BOTH SPEAKER JOHNSON AND
MAJORITY LEADER THUNE HAVE
INDICATED TO THEIR MEMBERS AND
PRESS REPORTS THAT THEY WANT TO
HIT THE GROUND RUNNING, SO ON
JANUARY 3RD, THE NEW CONGRESS
WILL MEET.
WE'LL HAVE THE HOUSE SPEAKER
ELECTION.
JANUARY 6TH THE ELECTORAL VOTES
WILL BE COUNTED IN A JOINT
SESSION.
PRESIDENT TRUMP WILL BE SWORN IN
ON JANUARY 20TH, AND THEN
JANUARY, THE CONFIRMATION
PROCESS FOR TRUMP NOMINEES WILL
REALLY GET GOING, TYPICALLY THE
SENATE WILL START WITH NATIONAL
SECURITY RELATED NOMINATIONS,
BUT THEN THEY WILL MOVE TO THE
REST OF THE CABINET, AND THEN
THE TRUMP ADMINISTRATION WILL BE
WORKING ON ITS FIRST 100 DAYS
AGENDA.
SO FAR WE'VE BEEN HEARING FROM
BOTH CONGRESSIONAL LEADERS AND
THE TRUMP ADMINISTRATION THAT
THEIR GOALS FOR THE FIRST 100
DAYS WILL REVOLVE AROUND TAX
LEGISLATION, BUDGET
RECONCILIATION, AND BORDER
POLICY.
I DID JUST WANT TO GO OVER VERY
QUICKLY THE PROCESS FOR NIH
DIRECTOR CONFIRMATION.
ONCE THE PRESIDENT ANNOUNCES A
NOMINATION, THE NOMINEE WILL BE
MEETING WITH A NUMBER OF
MEMBERS, THEY WILL THEN HAVE A
COMMITTEE HEARING THIS WILL BE
IN FRONT OF OUR AUTHORIZING
COMMITTEE ON THE SENATE SIDE,
HEALTH, EDUCATION AND PENSIONS.
THERE WILL NEED TO BE A
COMMITTEE VOTE REPORTING OUT THE
NOMINEE AND THEN THAT WILL NEED
TO FOLLOW WITH A FULL SENATE
CONFIRMATION VOTE ON THE FLOOR.
AND I WILL LEAVE IT THERE.
THANK YOU.
>> OKAY.
THANK YOU VERY MUCH.
I THINK WE GO BACK TO THE REST
OF THE SLIDE DECK.
I HAVE A FEW MORE COMMENTS TO
MAKE AND THEN WE'LL TAKE
QUESTIONS.
THE NEXT SECTION IS ABOUT
POLICIES.
POLICIES AND, AS YOU KNOW,
POLICYPOLICY'S CRITICALLY IMPORT
ROLE HERE AT NIH TO SET THESE
STRUCTURES THAT ALLOW THE ENTIRE
ENTERPRISE TO FUNCTION
OPTIMALLY.
LET ME START WITH THE FIRST ONE.
YOU'LL HEAR MORE ABOUT THIS
LATER THIS AFTERNOON, BUT I'LL
MENTION RIGHT NOW THAT WE'VE
RESTARTED THE SCIENTIFIC
MANAGEMENT REVIEW BOARD AND HELD
THE FIRST MEETING OF THIS BOARD
ON NOVEMBER 12TH.
THIS BOARD ADVISES AND MAKES
RECOMMENDATIONS TO THE HHS
SECRETARY AND TO THE NIH
DIRECTOR ON THE USE OF OUR
ORGANIZATIONAL AUTHORITIES TO
ESTABLISH OR ABOLISH INSTITUTES
AND CENTERS AT NIH, TO ORGANIZE
OFFICES WITHIN THE OFFICE OF THE
DIRECTOR, AND TO ORGANIZE BOTH
WITHIN AND ACROSS ALL OF THE
INSTITUTES AND CENTERS OF NIH.
WE HAVE NOW REQUESTED THAT THE
NEWLY CONVENED SMRB EVALUATE THE
CURRENT STRUCTURE OF NIH, AND
PROPOSE CHANGES THAT WILL
ENHANCE THE ABILITY OF THE
AGENCY TO VILI FUA FULFILL ITS .
THE SMRB WILL INCLUDE A NUMBER
OF FACTORS INCLUDING RECENT
PROPOSALS FROM BOTH THE HOUSE
AND THE SENATE.
NOW SPECIFIC POLICY UPDATES
STARTING WITH THE SCIENTIFIC
INTEGRITY POLICY.
LET ME JUST START HERE BY
THANKING DR. LYRIC JORGENSON WHO
IS THE LEAD FOR ALL OF OUR
POLICY OPERATIONS HERE AND ALSO
DR. LARRY TABAK, WHO HAS REALLY
BEEN A CRITICAL PARTNER IN
DEVELOPING THE POLICIES YOU'LL
HEAR ABOUT TODAY.
SCIENTIFIC INTEGRITY POLICY,
ENSURING THE HIGHEST LEVEL OF
SCIENTIFIC INTEGRITY, PUBLIC
ACCOUNTABILITY, AND SOCIAL
RESPONSIBILITY IN THE CONDUCT OF
SCIENCE IS PARAMOUNT TO
CULTIVATING TRUST.
IN OCTOBER WE PUBLISHED OUR
SCIENTIFIC INTEGRITY POLICY,
WHICH WILL GO INTO EFFECT ON
DECEMBER 30TH, 2024.
THE POLICY REAFFIRMS OUR
COMMITMENT TO SCIENTIFIC
INTEGRITY AND TRANSPARENCY.
IT OUTLINES ALREADY EXISTING
PROCEDURES AT NIH THAT PROMOTE
SCIENTIFIC INTEGRITY, WHILE
INTRODUCING SOME NEW ROLES AND
RESPONSIBILITIES TO FURTHER
STRENGTHEN THESE PRACTICES
ACROSS NIH.
THIS POLICY ALIGNS WITH THE
OVERALL HEALTH AND HUMAN
SERVICES SCIENTIFIC INTEGRITY
POLICY, BOTH OF WHICH WERE
INFORMED BY A 2021 PRESIDENTIAL
MEMORANDUM ON RESTORING TRUST IN
GOVERNMENT THROUGH SCIENTIFIC
INTEGRITY AND EVIDENCE-BASED
POLICYMAKING.
AND ALSO GUIDANCE FROM THE
NATIONAL SCIENCE AND TECHNOLOGY
COUNCIL.
THE POLICY AIMS TO ENSURE THAT
SCIENTIFIC FINDINGS ARE
OBJECTIVE, CREDIBLE, AND RED LEA
AVAILABLE TO THE PUBLIC, AND
THAT THE DEVELOPMENT AND
IMPLEMENTATION OF POLICIES AND
PROGRAMS IS TRANSPARENT,
ACCOUNTABLE AND ALSO
EVIDENCE-BASED.
THE POLICY OUTLINES EXISTING
PROCEDURES AND INTRODUCES NEW
ROLES AND RESPONSIBILITIES.
SUCH AS THE NIH CHIEF SCIENTIST.
CURRENTLY THIS ROLE IS HELD BY
THE NIH PRINCI PRINCIPAL DEPUTY
DIRECTOR, DR. LARRY TABAK,
PROVIDES OVERSIGHT OF ALL NIH
SCIENTIFIC INTEGRITY POLICIES
AND PROCEDURES.
THE SCIENTIFIC INTEGRITY
OFFICIAL, THIS ROLE RESIDES IN
THE ASSOCIATE DIRECTOR FOR
SCIENCE POLICY, DR. LYRIC
JORGENSON OVERSEES THE
IMPLEMENTATION AND ITERATIVE
IMPROVEMENT OF NIH POLICIES AND
PROCEDURES THAT PROMOTE
SCIENTIFIC INTEGRITY, AND
FINALLY A SCIENTIFIC INTEGRITY
COUNCIL THAT COMPRISES CAREER
EMPLOYEES WILL ASSIST THE
SCIENTIFIC INTEGRITY OFFICIAL IN
ITERATIVE REVIEW, POLICY
DEVELOPMENT AND PRIORITY
SETTING, TO ENSURE THAT THE
EXISTING POLICIES AND PROCEDURES
ARE ALWAYS RESPONSIVE TO ISSUES
THAT ARISE IN THE SCIENTIFIC
INTEGRITY SPACE.
LET ME JUST EMPHASIZE AGAIN,
SCIENTIFIC INTEGRITY IS A CORE
OF WHAT WE DO AT NIH BUT LIKE
ANYTHING IN THE POLICY ARENA,
CONTINUAL ATTENTION AND REFRESH
IS ALWAYS IMPORTANT.
NIH HAS LONG CHAMPIONED ROBUST
OVERSIGHT TO RESPONSIBLY FUEL
KNOWLEDGE IN SUPPORT OF
IMPROVING HUMAN HEALTH.
A NEW POLICY FOR OVERSIGHT OF
DUAL USE RESEARCH OF CONCERN AND
PATHOGENS WITH ENHANCED PANDEMIC
POTENTIAL.
WAS ISSUED ON MAY 6,
2024, AND GOES INTO EFFECT ON
MAY 6, 2025.
THIS POLICY, WHICH NIH IS NOW IN
THE PROCESS OF IMPLEMENTING,
STRENGTHENS PAST OVERSIGHT OF
THIS TYPE OF RESEARCH AND MERGES
EXISTING BIOSECURITY POLICIES TO
UNIFY AND HARMONIZE APPROACHES
FOR PROMOTING THE BENEFITS OF
RESEARCH WHILE MITIGATING THE
RISKS.
THE POLICY FORECASTED NEEDS
ASSOCIATED WITH INCREASING
EVOLUTION AND USE OF NEW
COMPUTATIONAL MODELS AND
APPROACHES INCLUDING THE USE OF
ARTIFICIAL INTELLIGENCE.
LOOKING AHEAD, WE MUST ALSO
CONTINUE TO STRENGTHEN AND
EVOLVE AS WE CONSIDER HOW TO
BEST SAFEGUARD INSILICO RESEARCH
WITH POTENTIAL DUAL USE
CONCERNS.
AT THE NOVEMBER 21ST MEETING OF
THE NATIONAL SCIENCE ADVISORY
BOARD FOR BIOSECURITY, NIH PUT
FOOFORWARD A CHARGE TO THE BOARO
RECOMMEND STRATEGIES FOR
IDENTIFYING AND OPTIONS FOR
MITIGATING POTENTIAL RISKS
ASSOCIATED WITH INSILICO
RESEARCH, COMPUTATIONAL MODELS,
INCLUDING THOSE DRIVEN BY A.I.,
AND DATASETS IN LIFE SCIENCE
SETTINGS.
ALSO, OUTLINE OPTIONS FOR
PROMOTING RESPONSIBLE INNOVATION
WHILE MITIGATING POTENTIAL RISK,
AND FINALLY, EXPLORE OPTIONS FOR
PROMOTING THE HIGHEST STANDARDS
OF TRA TRANSPARENCY WHILE
SAFEGUARDING RESEARCH AND
RESEARCH OUTPUTS.
WE EXPECT TO RECEIVE
RECOMMENDATIONS FROM THE
NATIONAL SCIENCE ADVISORY BOARD
FOR BIOSECURITY IN
DECEMBER 2025.
WE MUST BRING THE BENEFITS OF
RESEARCH TO ALL AMERICANS
REGARDLESS OF WHERE THEY LIVE.
WE KNOW THAT MEANINGFUL
ENGAGEMENT BETWEEN COMMUNITIES
AND RESEARCHERS IS ESSENTIAL TO
LEAD TO HIGHER QUALITY SCIENCE,
ESSENTIAL TO ENGENDER TRUST IN
SCIENCE BY ADDRESSING THE NEEDS
OF DIFFERENT COMMUNITIES, AND
FOCUSES RESEARCH ON THE ISSUES
MOST IMPORTANT TO DIVERSE
COMMUNITIES.
WITHOUT THIS, WE RUN THE RISK OF
ONLY SERVING THE FEW.
AND WE ARE HERE TO SERVE
EVERYONE.
WE TURN TO THE NOVEL AND
EXCEPTIONAL TECHNOLOGY AND
RESEARCH ADVISORY COMMITTEE,
BETTER KNOWN AS NEXTTRAK, TO
ASSIST NIH IN ESTABLISHING AN
AGENCY-WIDE VISION AND FRAMEWORK
FOR ROUTINELY INCLUDING PUBLIC
VOICES THROUGHOUT THE CLINICAL
RESEARCH LIFECYCLE.
THE NEXTTRAK PROVIDES
RECOMMENDATIONS TO THE NIH
DIRECTOR AS WELL AS A PUBLIC
FORUM FOR THE DISCUSSION OF THE
SCIENTIFIC, SAFETY AND ETHICAL
ISSUES ASSOCIATED WITH PRESENT
AND EMERGING BIOTECHNOLOGIES.
YOU'LL HEAR MORE ABOUT THIS FROM
LYRIC JORGENSON LATER TODAY, BUT
I WANTED TO BRIEFLY MENTION ONE
WORKING GROUP OF NEXTTRAK, THE
ENGAGE WORKING GROUP, AND LET
YOU KNOW WHY IT'S SO IMPORTANT.
I SEE TREMENDOUS VALUE IN
PROVIDING INSTITUTIONS,
RESEARCHERS, AND COMMUNITIES
EVERYWHERE, A ROTE MAP FOR HOW
TO ENGAGE BOTH WITH EACH OTHER
AND WITH US TO BRING THE VISION
OF PARTICIPANTS IN AS PARTNERS
AND MAKE THIS A REALITY, NOT
SOMETHING THAT EXISTS ONLY IN
THEORY.
IT'S ONE THING TO HAVE GOOD
INTENTIONS.
IT'S ABSOLUTELY CRITICAL THAT WE
ARE ABLE TO EXECUTE.
AS SUCH, WE'VE ASKED NETRAC TO
ESTABLISH A FRAMEWORK FOR PUBLIC
ENGAGEMENT THAT INCLUDES
APPROACHES THAT ARE APPROPRIATE
FOR THE BREADTH AND DIVERSITY OF
NIH FUNDED CLINICAL RESEARCH
STUDIES.
ADDITIONALLY TO SUPPORT THESE
EFFORTS WITHIN NIH, WE'VE
CONVENED INTERNAL NIH EXPERTS
COMMITTED TO EMBEDDING COMMUNITY
ENGAGEMENT IN NIH PROGRAMS TO
CENTRALLY ADDRESS ISSUES AND
SOLUTIONS FOR IMPROVING
MEANINGFUL PUBLIC ENGAGEMENT
ACROSS THE AGENCY.
NEXT THE PUBLIC ACCESS POLICY.
NIH HAS A LONG HISTORY OF
PROVIDING PUBLIC ACCESS TO
SCHOLARLY PUBLICATIONS,
RESULTING FROM THE RESEARCH IT
SUPPORTS.
OUR 2028 PUBLIC ACCESS POLICY
HAS RESULTED IN OVER 1.5 MILLION
ARTICLES FROM NIH SUPPORTED
RESEARCH BEING MADE FREELY
AVAILABLE ON THE NATIONAL
LIBRARY OF MEDICINE HOSTED
PUBMED CENTRAL.
HOWEVER, THIS POLICY IMPLEMENTED
IN 2028 ALLOWS FOR AN EMBARGO OF
UP TO 12 MONTHS BEFORE THESE
ARTICLES NEED TO BE MADE FREELY
AVAILABLE TO THE PUBLIC.
WELL, THIS SUMMER, WE RELEASED A
DRAFT PUBLIC ACCESS POLICY THAT
PROPOSES REMOVING THIS EMBARGO
PERIOD TO ALLOW ENHANCED AND
MORE TIMELY ACCESS TO THE
RESULTS OF RESEARCH.
THIS DRAFT POLICY IS CONSISTENT
WITH THE GUIDANCE FROM A 2022
WHITE HOUSE OFFICE OF SCIENCE
AND TECHNOLOGY POLICY
MEMORANDUM, APPLICABLE TO ALL
U.S. GOVERNMENT AGENCIES FUNDING
RESEARCH.
NIH RECEIVED 144 COMMENTS FROM A
VARIETY OF CONSTITUENCIES AND WE
REACHED OUT FOR INPUT ON THIS.
WE PUBLISHED THE COMPILED PUBLIC
COMMENTS ONLINE, AND I AM NOW --
CAN NOW ANNOUNCE THAT THE
UPDATED PUBLIC ACCESS POLICY
WILL BE RELEASED BEFORE THE END
OF THIS CALENDAR YEAR.
WE'VE DISCUSSED THIS ONE BEFORE.
HERE'S A FOLLOW-UP.
THE ACD WORKING GROUP ON
DIVERSITY'S SUBGROUP ON
INDIVIDUALS WITH DISABILITIES
RECOMMENDED THAT WE REMOVE THE
LANGUAGE OF "REDUCING
DISABILITY" FROM THE NIH MISSION
STATEMENT.
NIH ISSUES A REQUEST FOR
INFORMATION INVITING COMMENTS
AND SUGGESTIONS ON UPDATING OUR
MISSION STATEMENT IN THIS WAY.
BEING RESPONSIVE TO OUR ACD
WORKING GROUP.
IN OCTOBER, WE POSTED A PUBLIC
REPORT ON THIS REQUEST FOR
INFORMATION TO THE NIH WEBSITE.
THE REPORT NOTES THAT WE
RECEIVED VERY STRONG OPPOSING
VIEWS IN RESPONSE TO THE RFI,
AND THAT THESE INDICATE THAT WE
NEED MORE INPUT TO BETTER
UNDERSTAND ALL PERSPECTIVES
BEFORE TBIENL FIENL FINALIZING N
STATEMENT.
TRULY WE NEED OUR MISSION
STATEMENT TO BE RESPONSIVE TO
THE COMMUNITIES THAT WE SERVE,
AND IF THERE IS DEBATE
PARTICULARLY WITHIN THE
DISABILITY COMMUNITY, AS TO WHAT
THE RIGHT WAY TO PROCEED FOR
ISSUES RELEVANT TO THEM, WE NEED
TO START THIS OUT BETTER BEFORE
MOVING FORWARD.
SO THAT'S WHAT WE'RE DOING.
WE'VE HOSTED A SERIES OF VIRTUAL
COMMUNITY ROUNDTABLES AND A
VIRTUAL TOWN HALL TO TBEAR MOREE
COMMUNITY INPUT ON THE MISSION
STATEMENT, ALL OF IT, BUT MOST
SPECIFICALLY, TOPICS RELATED TO
THE DISABILITY RESEARCH
STRATEGIC PLAN DEVELOPMENT
PROCESS, AND YOU'LL HEAR MORE
ABOUT THIS IN A SESSION LATER
THIS AFTERNOON.
SO ADDITIONAL COMMUNITY
ENGAGEMENT IS PLANNED OVER THE
NEXT SEVERAL MONTHS.
WE REALLY LOOK FORWARD TO
WORKING WITH EVERYONE CONCERNED
ABOUT HOW BEST TO SERVE PEOPLE
WITH DISABILITIES THROUGH THIS
WORK.
OKAY.
YOU'VE HEARD THAT WE'RE HAVING
THE OUTLINES OF WHAT WE EXPECT
TO SEE WITH AN INCOMING
ADMINISTRATION AND A NEW
CONGRESS.
THE EXCEPTIONALLY TALENTED TEAM
AT NIH, ITS LEADERS,
ADMINISTRATIVE STAFF,
RESEARCHERS, TRAINEES, AND ALL
OF NIH'S AMAZING SUPPORT STAFF
ARE READY -- STAND READY TO
CONTINUE TO SERVE OUR NATION BY
DRIVING SCIENTIFIC ADVANCES THAT
IMPROVE HEALTH FOR EVERYONE.
TIMES OF TRANSITION ARE ALWAYS
CHALLENGING, BUT UNWAVERING
COMMITMENT TO OUR MISSION ON
BEHALF OF THE AMERICAN PEOPLE
GROUNDS EVERYBODY AT NIH.
NIH WILL CONTINUE TO BENEFIT
FROM SOLID CONGRESSIONAL SUPPORT
ON BOTH SIDES OF THE POLITICAL
DIVIDE, AS WELL AS SUPPORT FROM
PARTNERS IN ACADEMIA, INDUSTRY,
NON-PROFIT FOUNDATIONS, AND MOST
IMPORTANT OF ALL FROM PEOPLE IN
ALL WALKS OF LIFE THROUGHOUT THE
UNITED STATES.
SO WE ARE SURE THAT WE CAN ALL
MOVE FORWARD WITH OPTIMISM AND
ENERGY AS WE NAVIGATE CHANGES
BROUGHT ON BY A NEW
ADMINISTRATION.
OKAY.
NOW I WOULD LIKE TO TALK ABOUT
SOME UPDATES ON HOW WE FOLLOWED
UP ON WORKING GROUP
RECOMMENDATIONS FROM THIS
COMMITTEE.
AT OUR LAST MEETING IN JUNE I
DISCUSSED A NUMBER OF EFFORTS
NIH IS TAKING TO ADDRESS MANY
CHALLENGES AFFECTING THE
POSTDOCTORAL TRAINEE COMMUNITY,
INCLUDING INCREASED POSTDOCTORAL
STIPENDS AND CHILD CARE SUPPORT,
TIGHTENED THE DEFINITION OF WHAT
CONSTITUTES A POSTDOCTORAL
SCHOLAR, AND CLARIFIED MANY OF
THE POLICIES RELATED TO
POSTDOCTORAL TRAINING.
I WILL NOTE THAT AS OUR BUDGETS
ALLOW, NIH WILL CONTINUE TO MAKE
PROGRESS TOWARD INCREASING THE
NRSA'S POSTDOCTORAL SCHOLAR
STIPENDS TO ACHIEVE A MINIMUM OF
$70,000 A YEAR.
I ALSO MENTIONED THAT WE WERE
DEVELOPING IMPLEMENTATION TEAMS
AND FINALIZING ANOTHER REQUEST
FOR IMPLEMENTATION ON THIS TOPIC
THAT THE WORKING GROUP HERE GAVE
US A LOT OF DEEP ISSUES TO WORK
THROUGH AND WE CONTINUE DOING
THIS.
WE ISSUED A FOLLOW-UP RFI ON
JULY 25TH, AND IT CLOSED ON
OCTOBER 23RD, AND WE'RE IN THE
PROCESS OF REVIEWING THE
RESPONSES.
THIS REQUESTED INPUT FROM THE
BIOMEDICAL RESEARCH COMMUNITY ON
HOW WE CAN BEST IMPLEMENT THE
ADDITIONAL REQUIREMENTS OF THE
ACD WORKING GROUP.
ONE RECOMMENDATION NOTED THAT WE
SHOULD LIMIT THE TOTAL NUMB WE F
YEARS THAT A PERSON CAN BE
SUPPORTED BY NIH FUNDS IN A
POSTDOCTORAL POSITION TO NO MORE
THAN FIVE YEARS.
THE GOAL HERE IS TO FACILITATE A
FASTER TRANSITION OF OUR
TRAINEES TO INDEPENDENT RESEARCH
CAREERS.
THE RFA ASKED RESPONDENTS TO
CONSIDER FACTORS LIKE EXISTING
POLICIES THAT ARE OPERATIVE IN
OUR INSTITUTIONS AND OTHER
TRAINEE SUPPORT ORGANIZATIONS.
HOW WOULD A CHANGE IN POLICY --
HOW THEIR POLICIES WOULD WORK IF
NIH WERE TO LIMIT TOTAL YEARS OF
NIH SUPPORTED FUNDING, AND WHAT
MECHANISMS COULD BE PUT INTO
PLACE TO BETTER SUPPORT
TRANSITION TO INDEPENDENT
CAREERS.
THE LAST THING WE WANT TO DO IS
TO INTRODUCE HARM BY ANY CHANGE
IN POLICIES THAT'S INTENDED TO
BE MORE SUPPORTIVE.
THE WORKING GROUP ALSO
RECOMMENDED THAT NIH REVISED THE
K99/R00 MECHANISM TO FOCUS ON
IDEAS AND CREATIVITY OVERJUST
PRODUCTIVITY EXPERIENCE AND TO
ADAPT THE REVIEW AND AWARD
PROCESSES.
THE KEY CONCERN HERE IS THAT
APPLICATIONS WHO ALREADY HAVE
MORE RESEARCH AND MORE
PUBLICATIONS CAN SCORE BETTER IN
REVIEW AND ARE MORE LIKELY TO BE
FUNDED.
THE RFA ASKED RESPONDENTS TO
CONSIDER CHALLENGES IN LIMITING
THE ELIGIBILITY TIME FRAME AND
WAYS THAT THE REVIEW CRITERIA
COULD BETTER EMPHASIZE NEW
CREATIVE IDEAS AND RESOURCES
THAT MIGHT BE NEEDED AGAIN TO BE
DEVELOPED TO AVOID ANY NEGATIVE
IMPACT OP TRAINEES WITH MORE OF
A FOCUS ON CREATIVITY AND IDEAS
RATHER THAN EXPERIENCES AND
RESOURCES.
ANOTHER RECOMMENDATION SAID THAT
NIH SHOULD PROMOTE TRAINING AND
PROFESSION DEVELOPMENT TO
POSTDOCTORAL SCHOLARS AND THEIR
MENTORS.
THESE ARE INTEGRAL ELEMENTS OF
THE POSTDOCTORAL EXPERIENCE BUT
WE UNDERSTAND THAT MANY
RESEARCHERS, MANY MENTORS FEEL
PRESSURE TO FOCUS SOLELY ON
RESEARCH AND DON'T HAVE TIME TO
PURSUE THESE OPPORTUNITIES.
SO THIS RFA ASKED APPLICATIONS
TO CONSIDER HOW THESE BECOME
INTEGRATED, MEANING POLICIES TO
PROMOTE PROFESSIONAL DEVELOPMENT
OF SCHOLARS AND THEIR MENTORS,
HOW CAN THESE POLICIES BE
INTEGRATED AND MEASURED
COMPONENTS OF THE POSTDOCTORAL
EXPERIENCE, AND TO ADDRESS
FACTORS SUCH AS HOW INSTITUTIONS
CAN ADDRESS BARRIERS TO
PARTICIPATION, AND OF COURSE HOW
MENTORS CAN BE BETTER SUPPORTED
AND MORE EFFECTIVE.
SO AS PART OF THIS EFFORT, ALL
OF THESE EFFORTS, THE NIH OFFICE
OF EXTRAMURAL RESEARCH HAS
RECENTLY IMPLEMENTED A NEW
REQUIREMENT FOR MENTOR TRAINING,
FOR NIH INSTITUTIONAL RESEARCH
TRAINING GRANTS.
THIS EFFORT IS IMPLEMENTED TO
ENSURE THAT MENTORS ARE
RECEIVING THE SUPPORT AND
EDUCATION THEY NEED AROUND THE
MOST EFFECTIVE MENTORING
PRACTICES SO THAT THEY'RE
PREPARED TO SUPPORT THE HOLISTIC
NEEDS OF POSTDOCS AND PRE-DOCS
OF TODAY AND TOMORROW.
NOW THAT THE RFI IS CLOSED,
WE'RE FINALIZING AND CHARGING
IMPLEMENTATION TEAMS FOCUSED ON
THE RECOMMENDATIONS.
WE EXPECT TO PUBLISH AN
EXECUTIVE SUMMARY AND RESULTS IN
EARLY SPRING NEXT YEAR, AND I'LL
LET YOU KNOW.
THERE WERE MORE THAN 500
RESPONDENTS WITH VARIOUS
PROFESSIONAL ROLES AND
RESPONSIBILITIES, INCLUDING
POSTDOCTORAL SCHOLARS, FACULTY,
ACADEMIC LEADERS, RESEARCH
SCIENTISTS, PEOPLE FROM ADVOCACY
GROUPS AND PROFESSIONAL SOCIETY,
GRADUATE STUDENTS AND PEOPLE WHO
WORK FOR GOVERNMENT AGENCIES AND
SCIENTIFIC RESEARCH
ORGANIZATIONS.
AND THE MAJORITY, 82% OF
RESPONDENTS, WERE AFFILIATED
WITH AN ACADEMIC INSTITUTION, A
MEDICAL SCHOOL OR A HOSPITAL.
SO LOTS TO DO TO MAKE LIFE
BETTER FOR OUR TRAINEES, AND
WE'RE GRATEFUL FOR THE ACD IN
GUIDING THIS EFFORT.
LOOKING AHEAD TO FISCAL YEAR 26
AND 27, NIH PLANS TO CONTINUE TO
ADDRESS SOME KEY ASPECTS OF
ADDITIONAL WORKING GROUP
RECOMMENDATIONS, INCLUDING THOSE
FOCUSED ON SUPPORTING TRANSITION
FOR OTHER TYPES OF ROLES,
INCLUDING TRAINING, SAFE
ENVIRONMENTS, AND IMPROVED DATA
SHARING.
MOVING ON TO NEW APPROACH
METHODOLOGIES, OTHERWISE KNOWN
AS NAMs, WHICH ARE LAB OR
COMPUTER-BASED RESEARCH
APPROACHES TO MORE ACCURATELY
MODEL HUMAN BIOLOGY AND
COMPLEMENT OR IN SOME CASES
REPLACE TRADITIONAL RESEARCH
MODELS.
AS I NOTED IN OUR LAST MEETING,
NIH IS WORKING TO ADDRESS THE
RECOMMENDATIONS IN THIS REGARD
LAID OUT BY THE ACD WORKING
GROUP.
NIH'S COMPLEMENT-ANIMAL RESEARCH
IN EXPERIMENTATION, OTHERWISE
CALLED COMPLEMENT-ARIE PROGRAM,
IS SUPPORTED BY THE COMMON FUND.
IT AIMS TO FURTHER ACD
RECOMMENDATIONS BY ACCELERATING
THE DEVELOPMENT,
STANDARDIZATION, VALIDATION AND
IMPORTANTLY THE USE OF NEW
MODELS AND APPROACHES THAT WILL
MORE ACCURATELY MODEL HUMAN
BIOLOGY, AND CAN COMPLEMENT OR
IN SOME CASES REPLACE
TRADITIONAL MODELS THAT MIGHT
NOT BE AS GOOD.
WE PLAN TO ISSUE A NOTICE OF
FUNDING OPPORTUNITY THIS MONTH
TO SUPPORT A DATA HUB AND
COORDINATING CENTER THAT WILL
COLLECT, STORE, CURATE AND
DISSEMINATE ALL NAMs RELATED
DATA, METADATA, ANALYSES, TOOLS,
COMPUTATIONAL MODELS, AND
VALIDATION AND QUALIFICATION
DOCUMENTS.
ALL OF THESE PRODUCTS GENERATED
BY THE COMPLEMENT-ARIE PROGRAM,
AND TO DO SO IN A MANNER THAT
PROMOTES DEVELOPMENT OF
STANDARDS EAND SU AND ENSURES TW
EFFORTS WILL HAVE MAXIMUM
INTEROPERABILITY WITH DATA FROM
OTHER NEW APPROACH METHODOLOGIES
RELATED REPOSITORIES AND
CONSORTIA.
ON DECEMBER 10TH, WE PUBLISHED A
NOTICE OF FUNDING OPPORTUNITY TO
SUPPORT TECHNOLOGY DEVELOPMENT
CENTERS THAT WILL WORK
SPECIFICALLY TO DEVELOP
COMBINATORIAL PERHAPS.
COMPLEMENT-ARIE HAS ALSO BEEN
APPROVED TO LAUNCH A PUBLIC
PRIVATE PARTNERSHIP WITH THE
FOUNDATION FOR NIH FOR A
VALIDATION AND QUALIFICATION
NETWORK TO SUPPORT THE ADOPTION
AND IMPLEMENTATION OF NAMs.
I THINK THIS IS A REALLY
IMPORTANT SCIENTIFICALLY
GROUNDED WAY TO MOVE FORWARD
WITH NEW TECHNOLOGY IN A
RESPONSIBLE WAY TO MAKE SURE
THAT EVERYONE BENEFITS.
NIH CONTINUES TO ADVANCE THE
VALIDATION AND REGULATORY
IMPLEMENTATION OF NAMs IN
PARTNERSHIP WITH OTHER FEDERAL
AGENCIES BY AN INTERAGENCY
COORDINATION COMMITTEE ON
VALIDATION OF ALTERNATIVE
METHODS.
UNDER THIS COMMITTEE, THE
NATIONAL INSTITUTE OF
ENVIRONMENTAL HEALTH SCIENCES IS
ACTIVELY DEVELOPING A COLLECTION
OF ALTERNATIVE METHODS FOR
REGULATORY APPLICATION OR CAMRA.
DEVELOPMENTS OF THE NATIONAL
TOXICOLOGY PROGRAM INTERAGENCY
CENTER FOR EVALUATION OF
ALTERNATIVE TOXICOLOGICAL
METHODS, CAMERA IS A NEW
INTERACTIVE SEARCHABLE WEB-BASED
DADATABASE THAT WILL ALLOW THE
SCIENTIFIC COMMUNITY TO ACCESS
STANDARDIZED, VALIDATED AND
QUALIFIED NEW APPROACH
METHODOLOGIES FOR REGULATORY AND
OTHER CONTEXT OF USE.
CAMERA WILL SUPPORT
REPRODUCIBILITY OF NIH FUNDED
RESEARCH, AND ADDRESS THE ACD
RECOMMENDATION TO ESTABLISH A
CENTRALIZED REPOSITORY TO PERMIT
NAMs DATA SHARING, ADOPTION
AND USE, AND A BETA VERSION IS
ANTICIPATED IN LATE SPRING 2024,
AND I'LL JUST ADD ANOTHER ASIDE
HERE, THAT THESE STANDARDS,
THESE APPROACHES, THESE
COLLABORATIVE METHODS THAT ARE
TRANSPARENT TO ALL ARE
ABSOLUTELY CRITICAL TO BE ABLE
TO UNDERSTAND DATA
REPRODUCIBILITY.
OKAY.
NEXT, WE HAVE TWO NEW ACD
WORKING GROUPS.
THANK YOU VERY MUCH FOR
ANSWERING THE CALL.
AS YOU HEARD, WE HAVE A NEW
EMPHASIS ON WHAT THE NATIONAL
LIBRARY OF MEDICINE CAN TAKE ON
TO PRODUCE THE DATA ECOSYSTEM
THAT OUR RESEARCH COMMUNITIES
ACROSS ALL ASPECTS, GOVERNMENT,
INDUSTRY, ACADEMIA, PRIVATE, CAN
DO.
AND THESE TWO WORKING GROUPS ARE
GOING TO HELP US ACHIEVE THAT.
ONE OF THEM IS THE -- HERE'S THE
ROSTER FOR THE NEW INFORMATION
TECHNOLOGY CYBERINFRASTRUCTURE
AND CYBERSECURITY WORKING GROUP,
WHICH WILL PROVIDE CRITICAL
INPUT ON NIH I.T. AND
CYBERSECURITY GOVERNANCE, AND
ARTICULATE HIGH PRIORITY AREAS
FOR NIH INVESTMENT IN
CYBERINFRASTRUCTURE,
CYBERSECURITY, A.I., DATA
SCIENCE, AMONG OTHER DUTIES.
THIS GROUP WILL PLAN TO PROVIDE
AN UPDATE TO THE ACD IN DECEMBE.
THANK YOU SO MUCH FOR TAKING ON
THIS IMPORTANT TASK.
HERE IS A ROSTER FOR THE NEXT
WORKING GROUP, THE ARTIFICIAL
INTELLIGENCE WORKING GROUP.
THIS TEAM IS CHARGED WITH
ARTICULATING A STRATEGIC AND
INTEGRATED VISION FOR BIOMEDICAL
RESEARCH OPPORTUNITIES THAT
WOULD BENEFIT FROM DEVELOPING AN
APPLICATION OF NOVEL A.I.
METHODS.
WE'VE ASKED THIS TEAM TO DELIVER
A FULL REPORT TO THE ACD TOWARD
THE END OF NEXT YEAR.
OKAY, NEXT SLIDE.
PROGRAMS AND INITIATIVES.
NEXT.
I AM SO -- LET ME JUST PREFACE
THIS WHOLE SECTION BY SAYING I
JUST CAN'T TELL YOU HOW GRATEFUL
I AM TO THE INCREDIBLE HARD WORK
OF THE TEAM OVER THE PAST YEAR.
AS I MENTIONED IN THE BEGINNING,
SO MANY THINGS THAT WERE AN IDEA
A YEAR AGO ARE REALITY TODAY, SO
PLEASE DON'T LET ANYBODY SAY NIH
IS SLOW.
THESE PROGRAMS ARE VERY EXCITING
AND I'M SO GRATEFUL FOR THE WORK
OF THE TEAM.
FIRST ONE, CARE FOR HEALTH.
NIH'S NEW PRIMARY CARE-BASED
RESEARCH NETWORK.
ALLOWS US TO CONNECT WITH
PRIMARY CARE PROVIDERS AND THEIR
PATIENTS AND THEIR COMMUNITIES,
GIVING THEM ACCESS TO RESEARCH,
INCLUDING THE OPPORTUNITY TO
PARTICIPATE IN CLINICAL TRIALS.
WE'RE WORKING ON IMPLEMENTATION
OF A SUSTAINED INFRASTRUCTURE
THAT INTEGRATES INNOVATIVE
RESEARCH WITH ROUTINE CLINICAL
CARE IN REAL WORLD SETTINGS WITH
A FOCUS ON SUSTAINED ENGAGEMENT
WITH HISTORICALLY
UNDERREPRESENTED COMMUNITIES,
THOSE EXPERIENCING HEALTH
DISPARITIES IN CLINICAL
RESEARCH.
THIS YEAR SAW BEGINNING WITH A
TWO-YEAR 30 MILLION-DOLLAR PILOT
INITIATIVE IN SEPTEMBER, WE
ANNOUNCED $5 MILLION IN
FIRST-YEAR FUNDING TO SUPPORT
THREE NETWORK RESEARCH HUBS,
THESE INCLUDE OREGON HEALTH AND
SCIENCE UNIVERSITY, COVERING
MULTIPLE STATES IN THE
NORTHWEST.
THE UNIVERSITY OF
WISCONSIN-MADISON, AND WEST
VIRGINIA UNIVERSITY.
INITIALLY THESE TEAMS WILL WORK
WITH 50 CLINICAL SITES IN RURAL
COMMUNITIES THROUGH THESE THREE
NETWORKS.
AS PART OF THE PILOT PHASE,
THESE NEW NETWORK RESEARCH HUBS
WILL PARTNER WITH THREE ONGOING
NIH FUNDED CLINICAL TRIALS.
WE HAVE THE FIRST, CARE FOR
HEALTH RESEARCH NETWORK MEETING
LAST WEEK, AND RECEIVED A
DETAILED OVERVIEW OF EACH OF
THESE PROJECTS.
I WANT TO EMPHASIZE THAT THESE
PROJECTS WERE SELECTED NOT BY
US, BUT BY THE COMMUNITIES THAT
ARE PARTICIPATING IN THIS
RESEARCH AS THE ONES THAT WERE
THE MOST MEANINGFUL TO THEM,
WHICH IS A KEY FEATURE OF THIS
WORK.
THE FIRST TRIAL KNOWN AS
BEATPAIN, HAS BEEN SUPPORTED BY
NIH'S HELPING TO END ADDICTION
LONG TERM OR HEAL INITIATIVE.
THE TRIAL IS EVALUATING A
TELEHEALTH-DELIVERED PHYSICAL
THERAPY IN PEOPLE WITH BACK PAIN
SEEKING CARE AT FEDERALLY
QUALIFIED HEALTH CENTERS.
THE TRIAL AIMS TO FIND WAYS TO
IMPROVE PAIN MANAGEMENT AND
REDUCE RELIANCE ON OPIOIDS,
WHILE CONSIDERING BARRIERS
FACING RURAL COMMUNITIES.
OREGON HEALTH AND SCIENCE
UNIVERSITY WILL BE WORKING WITH
THIS TRIAL TEAM TO EXTEND THIS
THROUGHOUT THEIR RURAL RESEARCH
NETWORK.
THE NEXT TRIAL ALSO SUPPORTED BY
HEAL IS CALLED CO-CARE.
THE PROJECT DESIGNS AND
EVALUATES A MULTIDISCIPLINARY
TREATMENT MODEL TO BE USED IN
THE PRIMARY CARE SETTING FOSH
PSETTING FORPEOPLE WITH POLYSUB.
FINALLY THE LAST TRIAL, WHICH IS
CALLED TRUST, WAS SELECTED BY
THE RESEARCHERS AT WEST VIRGINIA
UNIVERSITY.
IT COMPARES TWO COMMONLY USED
TREATMENT METHODS FOR GOUT TO
SEE HOW WELL THEY CAN IMPROVE
SYMPTOMS AND ALSO TO UNDERSTAND
THE EFFECTS OF THESE TREATMENT
METHODS ON QUALITY OF LIFE.
SO MOVING ON NOW TO THE NATIONAL
LIBRARY OF MEDICINE.
YOU'VE ALREADY HEARD ME TALK
ABOUT THIS.
WE HAVE A VISION FOR THE FUTURE
OF THE NLM AS A PLATFORM FOR
EVERYONE FOR BIOMEDICAL
DISCOVERY AND DATA POWERED
HEALTH.
AS PART OF THIS EFFORT, WE'VE
BEEN WORKING TO IMPLEMENT ACROSS
AGENCY INITIATIVE THAT WOULD
PROVIDE A FOCUS FOR COLLECTION
AND PRIVACY PROTECTED USE OF
DATA COLLECTED FROM THE CLINICAL
CARE ENVIRONMENT TO GENERATE
EVIDENCE REQUIRED FOR
DECISION-MAKING TO IMPROVE
HEALTH.
I'LL JUST EMPHASIZE, THIS IS A
PART OF THIS OVERALL DATA
ECOSYSTEM THAT INTENDS TO
ADDRESS OUR NEED TO INCLUDE
EVERYONE WHO WANTS TO BE
INCLUDED THROUGHOUT OUR NATION
IN BIOMEDICAL RESEARCH.
IN OUR CURRENT STATE, BOTH
PROCESSED AND RAW DATA FROM
HEALTH SYSTEMS, POPULATION
HEALTH DATA, FROM GOVERNMENT,
AND RESEARCH AND DEVELOPMENT
DATA FROM PHARMA ARE ALL SILOED
AND NON-INTEROPERABLE DESPITE
MANY EFFORTS.
HEALTHCARE INSTITUTIONS NOW SEND
DATA TO HHS FOR REQUIRED PUBLIC
HEALTH REPORTING PROGRAMS.
OFTEN, THAT SAME DATA FROM THE
SAME PATIENTS ARE COLLECTED MANY
TIMES FROM THE SAME INSTITUTION
TO BE THEN DISTRIBUTED TO
DIFFERENT FEDERAL AGENCIES.
THIS LEADS TO COLLECTION
REDUNDANCIES, EXPENSIVE DATA
FORMATTING CHALLENGES, AND
CREATES SILOS OF DATA HOLDING
ACROSS HHS FOR DATA ON PEOPLE'S
HEALTH.
THIS IS ALSO A HUGE BURDEN TO
THE CLINICAL CARE SITES.
WE REALLY MUST TRANSITION TO A
MODEL WHERE DATA IS
RECONFIGURABLE AND COMPUTABLE
AND CAN BE ALIGNED TO VARIOUS
USE CASES IN BOTH RESEARCH AND
PUBLIC HEALTH.
AS PART OF THIS NEW CROSS AGENCY
INITIATIVES, WE, TH THE NLM, WIL
SUPPORT A FEDERATED AND
ELECTRONIC HEALTH RECORD AND A
HEALTH DATA COLLECTION AND
TRANSMISSION ARCHITECTURE BASED
ON OPEN INDUSTRY DATA AND
INTEROPPABILITY STANDARDS
WORKING HAND IN HAND WITH THE
HHS OFFICE OF DATA -- OF A.I.
AND DATA STANDARDS.
WE WILL BE ABLE TO USE DATA FROM
THE CLINICAL CARE ENVIRONMENT TO
SUPPORT -- ALSO SUPPORT BOTH PRE
AND POST MARKET SURVEILLANCE AND
EFFECTIVENESS ASSESSMENTS,
DISEASE SURVEILLANCE AND
BIOMEDICAL RESEARCH.
OVERALL, WE WANT HHS TO BE ABLE
TO COLLECT AND USE THE HIGHEST
QUALITY DATA IN A MANNER THAT
REDUCES HEALTH PROVIDER BURDENS
AND IMPROVES DATA TIMELINESS,
QUALITY AND ANALYSIS.
THIS EFFORT REQUIRES A
COLLABORATIVE TRUSTED DATA
BROKER THAT CAN ACT AS A PARTNER
WITH HHS, THE HEALTHCARE
INDUSTRY, MEDICAL INSTITUTIONS,
THE RESEARCH COMMUNITY, AND
ULTIMATELY ALL OF THE PEOPLE WE
SERVE.
THIS ORGANIZATION WILL PROVIDE
THE INFRASTRUCTURE TO COLLECT,
AGGREGATE, MANAGE AND FACILITATE
REALTIME ACCESS TO DATA FROM
DESIGNATED PARTNER HEALTH
PROVIDER INSTITUTIONS.
IN ADDITION, THE TRUSTED DATA
BROKER WILL WORK WITH HHS TO
INCORPORATE NEW DATA TYPES,
IMPROVE DATA STANDARDS, AND
QUALITY, PILOT USE CASES, AND
ULTIMATELY, FACILITATE WHAT WE
ARE ALL LOOKING FOR ACROSS OUR
HEALTHCARE SYSTEM, A LEARNING
HEALTH SYSTEM.
WE HAVE AWARDED A $3.9 MILLION
TO THE FOUNDATION FOR NIH TO
DEVELOP STRATEGIC PLANS
INCLUDING INFRASTRUCTURE
STRATEGY, GOVERNANCE STRUCTURE
STRATEGY, PROGRAM MANAGEMENT AND
MONITORING SYSTEM FOR OUR
TRUSTED DATA BROKER, ESTABLISH
AN INSTITUTIONAL REVIEW BOARD,
ESTABLISH A PLATFORM FOR A
TRUSTED DATA BROKER FOR DATA
ACQUISITION, AND ALL OF THE
ACTIVITIES IT NEEDS TO
ACCOMPLISH, INCLUDING, AND
PERHAPS MOST ESPECIALLY,
ENSURING APPROPRIATE SECURITY
COMPLIANCE, AND ALSO TO
EVALUATION AND TESTING WITH HHS
PARTNERS, INCLUDING THE CDC,
CMS, FDA, AND NIH.
SO EXAMPLES.
JUST TO PUT SOME SPECIFICS ON
WHAT WE INTEND TO DO FOR DATA IN
THE CLINICAL CARE ENVIRONMENT.
HERE IS SOME CROSS HEALTH AND
HUMAN SERVICES PROJECTS
CURRENTLY UNDERWAY, TO ACHIEVE
BETTER DATA HEALTH COLLECTION.
THEY INCLUDE, FOR EXAMPLE,
CONSOLIDATING AND SIMPLIFYING
CANCER DATA REPORTING
REQUIREMENTS, THAT'S CDC,
NATIONAL PROGRAM OF CANCER
REGISTRIES, NIH'S SEER PROGRAM,
AND THE CENTIMET CMS ENHANCING Y
MODEL ALL NOW REQUIRE.
WOULDN'T IT BE GREAT IF YOU'RE
HEALTHCARE PROGRAMS PRODUCE THIS
DATA IN A STRAIGHTFORWARD,
SIMPLE ONE-TIME COLLECTION
SERVING ALL NEEDS METHOD.
THAT'S WHAT THIS FIRST PROJECT
IS STRIVING TO ACHIEVE.
SECOND, THE EXTENSIVE DATA THAT
FDA REQUIRES FOR SURVEILLANCE
PROGRAMS.
THERE'S A MODEL RIGHT NOW
LOOKING AT POST MARKET EFFECTS
OF GLP-1 AGONIST MEDICATIONS ON
CONDITIONS SUCH AS THYROID
CANCER AND TOBACCO USE THAT WILL
ALSO HELP DEVELOP THE MODEL TO
STREAMLINE OVERALL FDA
SURVEILLANCE DATA COLLECTION IN
THE FUTURE.
AND THEN FINALLY, ON THE
RESEARCH END, IMPROVING
LONGITUDINAL HEALTH RESEARCH
DATA COLLECTION REQUIRED FROM
THE ELECTRONIC HEALTH RECORD FOR
THE OBSERVATIONAL DATASETS OF
NIH'S ALL-OF-US PROGRAM.
SO I THINK WITH THESE EXAMPLES,
YOU CAN SEE THE COMPREHENSIVE
AND COLLABORATIVE ENVIRONMENT
THAT IS BEING USED TO BUILD THIS
DATA INITIATIVE.
ULTIMATELY, THIS IS OUR VISION
FOR THE FUTURE OF HEALTHCARE
DATA.
THE RIGHT DATA, THE RIGHT TIME
AND THE RIGHT PLACE.
DATA AND INFORMATION ARE BROUGHT
TOGETHER WITH PATIENT OWNING
THEIR OWN DATA, AND CONTROLLING
PERMISSION OF HOW THEIR DATA IS
USED FOR RESEARCH AND WHAT
PURPOSE.
SUCH A SYSTEM THAT WOULD
INTEGRATE RESEARCHERS WOULD LEAD
SIGNIFICANT INSIGHTS FOR
BIOMEDICAL SCIENCE, GUIDE PUBLIC
POLICY, DRIVE NEEDED HEALTHCARE
REFORM, AND, ABOVE ALL, ENGENDER
TRUST IN PATIENTS WHO CAN NOW
HAVE CONTROL OVER HOW THEIR DATA
IS USED FOR RESEARCH.
OKAY.
NEXT.
MOVING ON, DR. SARAH REID AND I
WILL PRESENT MORE ON THIS IN
DEPTH LATER TODAY BUT I WANTED
TO QUICKLY DISCUSS OUR RESEARCH
COVID TO ENHANCE RECOVERY OR
RECOVER INITIATIVE WHICH SEEKS
TO UNDERSTAND, DIAGNOSE, PREVENT
AND TREAT LONG COVID, I THINK
ANOTHER MAJOR STEP FORWARD OVER
THE LAST YEAR.
NIH ESTABLISHED RECOVER IN
FEBRUARY 2021, AFTER CONGRESS
INITIALLY APPROPRIATED
$1.5 BILLION IN THE MIDDLE OF
OUR HEALTH EMERGENCY TO US TO
STUDY THE LONG-TERM EFFECTS OF
COVID-19.
SINCE THEN, WE'VE MADE PROGRESS
IN UNDERSTANDING RISK FACTORS, A
BROAD RANGE OF SYMPTOMS
ASSOCIATED WITH LONG COVID, THE
IMPACT OF VACCINATION AND HEALTH
DISPARITIES.
WE'VE AMASSED AND SHARED DATA
FROM PATIENT COHORTS, CONDUCTED
FUNDAMENTAL PATHOBIOLOGY STUDIES
AND BEGUN REALLY CRITICAL
CLINICAL TRIALS.
BUILDING ON THESE CRITICAL
INSIGHTS, WE'RE EMBARKING ON THE
PROGRAM'S NEXT PHASE.
CALLED RECOVER-TREATING LONG
COVID.
TO PUT IT SIMPLY, WE NEED TO
EVALUATE MORE POTENTIAL
TREATMENTS FOR LONG COVID.
THIS IS A PERVASIVE AND VERY
CHALLENGING DISEASE.
IN THIS PROCESS, WE'RE ENSURING
THAT PATIENTS ARE MEANINGFULLY
ENGAGED AS OUR TRUE AND EQUAL
PARTNERS IN RESEARCH.
TO PUT IT QUITE DIRECTLY, WE
CANNOT SUCCEED WITHOUT HAVING
PATIENTS AT THE FOREFRONT,
PARTICULARLY OF THESE CLINICAL
TRIALS.
THE ONLY WAY TO DESIGN AND CARRY
OUT EFFECTIVE RESEARCH FOR LONG
COVID.
OUR GOAL IS TO ADDRESS THE NEEDS
OF THOSE SUFFERING FROM LONG
COVID BY BEING VERY TRANSPARENT
IN OUR APPROACH, FLEXIBLE AND
RESPONSIVE TO A CHANGING
LANDSCAPE THAT THEY ARE LIVING
EVERY DAY.
OKAY.
NOW ON OCTOBER 29TH, I WAS
PLEASED TO JOIN A WORKSHOP AT
THE WHITE HOUSE AS PART OF THE
WHITE HOUSE INITIATIVE ON
WOMEN'S HEALTH RESEARCH.
THE EVENT CONVENED EXPERTS FROM
ACROSS NIH TO HIGHLIGHT THE
INTERDISCIPLINARY RESEARCH
ADVANCES IN WOMEN'S HEALTH THAT
HAVE BEEN GOING ON, AND TO
DISCUSS FUTURE PRIORITIES.
AT NIH, WE TAKE A WHOLE PERSON
APPROACH THROUGHOUT A WOMEN'S
LIFETIME, RECOGNIZING THAT MANY
INTERCONNECTED FACTORS
CONTRIBUTE TO HEALTH AND KEYS.
DISEASE.
CAN YOU READ MORE ABOUT THIS IN
A NEW FACT SHEET ON THE OFFICE
OF WOMEN'S HEALTH RESEARCH
WEBSITE.
I ALSO PUBLISHED A BLOG LAST
MONTH EXPLAINING NIH'S OVERALL
VISION.
A FOLLOW-UP EVENT AT THE WHITE
HOUSE HOSTED BID PRESIDENT BIDEN
AND FIRST LADY JILL BIDEN TOOK
PLACE YESTERDAY, JOINING LEADERS
IN GOVERNMENT, ACADEMIC
RESEARCH, BUSINESS AND
PHILANTHROPY IN A CALL TO MAKE
DRAMATICALLY MORE PROGRESS AND
IMPROVE THE HEALTH OF ALL WOMEN.
TODAY I'D LIKE TO CLOSE WITH AN
EMPHASIS ON BASIC SCIENCE.
THIS IS OUR FOUNDATION.
NIH FUNDED BASIC RESEARCH
UNDERLIES ALL DRUGS APPROVED BY
THE FDA.
FOR INSTANCE, ALL THERAPIES THAT
WE PRODUCE FOR ANY NEEDED
PATIENT GROUP.
THIS IS JUST A VERY HIGH LEVEL
HEURISTIC THAT CONSIDERS SOME OF
THE BIOLOGICAL PROGRAMS THAT
HUMANS REQUIRE FOR OUR GROWTH
DEVELOPMENT AND MAINTENANCE OF
HEALTH.
EVERY ONE OF US DEVELOPS FROM A
SINGLE CELL, AND OUR BIOLOGY
CONSTANTLY CHANGES AS WE
TRANSITION THROUGHOUT OUR
VARIOUS LIFE STAGES FROM INFANTS
ALL THE WAY TO OLDER ADULT.
AND TO KEEP US HEALTHY IN THE
FACE OF DEMANDS FROM OUR
ENVIRONMENT, OUR LIFESTYLE, WE
MUST BE ABLE TO DO MANY THINGS.
RENEW EPITHELIUM THAT'S A
BARRIER BETWEEN US AND THE
EXTERNAL WORLD, HEAL THE WOUNDS
OF COMPLEX TISSUES, RESPOND TO
INFECTIOUS AGENTS, MAINTAIN THE
INTEGRITY OF OUR DNA.
FUNCTION IN THE FACE OF EITHER
FEAST OR FAMINE, AND DETOXIFY
HARMFUL SUBSTANCES.
THIS IS JUST A FEW OF THE
ABSOLUTELY INCREDIBLE THINGS
THAT OUR BODIES DO EVERY DAY.
AND WHEN ANY OF THESE CRITICAL
FUNCTIONS ARE THROWN OUT OF
BALANCE, DISEASE RESULTS.
AND THIS HEURISTIC, AS YOU SEE
LISTED HERE ON THE RIGHT,
REMINDS US OF THE VALUE OF
FUNDAMENTAL RESEARCH AS IT
ADDRESSES UNDERLYING PRINCIPLES
THAT SPAN MANY ORGAN SYSTEMS AND
ARE ALL NEEDED TO ADDRESS SO
MANY DISEASES.
IT CAN BE MANY YEARS BEFORE A
STRAND OF FUNDAMENTAL KNOWLEDGE
ABOUT HOW THE IMMUNE SYSTEM
WORKS, OR WHAT HAPPENS WITH DNA
DAMAGE REPAIR.
MIGHT BE AT FIRST OF INTEREST
ONLY TO A VERY SMALL NUMBER OF
ACADEMIC EXPERTS BUT THEN LEADS
TO A REALLY IMPORTANT NEW
TREATMENT.
IT IMPOSSIBLE TO PREDICT WHERE
IMPORTANT INSIGHTS OR
DISCOVERIES WILL TAKE PLACE OR I
PROMISE YOU WE'VE TRIED IF
POSSIBLE TO PREDICT WHO WILL BE
INVOLVED IN MAKING THESE.
IN FACT, THE DEVELOPMENT OF A
NEW DRUG OR ANY NEW TREATMENT
OFTEN STEMS FROM THE WORK OF
THOUSANDS OF SCIENTISTS AT
THOUSANDS OF ORGANIZATIONS OVER
MANY DECADES.
SO I JUST WANT TO REMIND
EVERYBODY OF NIH'S CORE
COMMITMENT TO INVESTMENT IN
BASIC SCIENCE.
IT MAXIMIZES OUR CHANCES FOR THE
BREAKTHROUGHS THAT ARE ESSENTIAL
FOR PROGRESS IN HEALTH.
I'VE HIGHLIGHTED A NUMBER OF
EXCITING SCIENTIFIC ADVANCES IN
THE NIH DIRECTOR'S BLOG
INCLUDING MANY BASIC RESEARCH
INSIGHTS.
I ENCOURAGE EVERYONE TO TAKE A
LOOK, YOU'LL LEARN MORE ABOUT
THE AMAZING SCIENCE THAT WE
SUPPORT ACROSS THE COUNTRY AND
THE WORLD AND WHAT'S HAPPENED
OVER THE LAST YEAR.
AS I END THIS, MY LAST REPORT TO
THE ACD AS NIH DIRECTOR, I JUST
WANT TO SAY HOW INCREDIBLY PROUD
I AM OF THE AMAZING TEAM AT NIH
OF WHAT THEY HAVE DELIVERED IN
RESPONSE TO THE NEEDS OF PEOPLE
ACROSS THE COUNTRY AND INDEED
THE WORLD OVER THE LAST YEAR CH
ONE THING, THOUGH, I HAVE TO DO,
THERE ARE SO MANY PEOPLE I WISH
I COULD THANK HERE TODAY, BUT
THERE IS ONE PERSON, TWO PEOPLE
I REALLY NEED TO CALL OUT WHO
HAVE BEEN AT MY SIDE EVERY
SINGLE STEP OF THE WAY.
THEY ARE DR. LARRY TABAK AND OUR
CHIEF OF STAFF, JOHN BER CLOA,
EVERY STEP OF THE WAY.
I PERSONALLY AS DIRECTOR
COULDN'T HAVE ACCOMPLISHED
ANYTHING I DID WITHOUT YOU.
YOUR WISDOM, DEDICATION TO
WHAT'S BEST FOR NIH ALWAYS AND
YOUR JUST PLAIN HARD WORK
24/7 HAS ALLOWED US TO SUCCEED
IN EVERYTHING WE'VE DONE OVER
THE YEAR THAT I'VE BEEN IN THIS
ROLE.
SO THANK YOU.
I'M SO GRATEFUL AND I CAN TELL
YOU SO ARE EVERYONE WHO ARE
SERVED BY NIH.
SO WITH THAT, I'D LIKE TO THANK
EVERYONE HERE AGAIN FOR JOINING
US TODAY, AND I'LL NOW OPEN IT
UP TO DISCUSSION.
>> SO BEFORE WE GO TO QUESTIONS,
I, DESPITE THOSE VERY KIND
WORDS, SCREWED UP AT THE
BEGINNING AND FAILED TO
ACKNOWLEDGE SEVERAL AD HOC
MEMBERS THAT ARE JOINING OUR
CHARTERED MEMBERS TODAY.
SO I JUST WANT TO ACKNOWLEDGE
WHO THOSE FOLKS ARE.
THEY'RE GOING TO BE COMING IN
AND OUT OF THE MEETING OVER THE
NEXT -- SO FIRST IS DR. MARK
NELSON, UNIVERSITY DISTINGUISHED
PROFESSOR AND CHAIR OF THE
DEPARTMENT OF PHARMACOLOGY AT
THE UNIVERSITY OF VERMONT,
COLLEGE OF MEDICINE.
AND IF I BUTCHER YOUR NAMES,
PLEASE CORRECT ME.
DR. RUSSELL VAN GELDER IS THE
PROFESSOR AND CHAIR OF THE
DEPARTMENT OF OPHTHALMOLOGY AT
THE UNIVERSITY OF WASHINGTON
MEDICAL SCHOOL.
AND DR. ELIZABETH VILLA IS A
HOWARD U INVESTIGATOR AND
PROFESSOR OF MOLECULAR BIOLOGY
AT U.C. SAN DIEGO.
SO I WANT TO WELCOME THOSE
INDIVIDUALS.
I HOPE SOME OF THEM ARE ON AT
THE MOMENT.
I KNOW THEY'RE GOING IN AND OUT,
AS WELL AS, OF COURSE, OUR
CHARTER MEMBERS.
WITH THAT, IF YOU COULD USE THE
RAISE YOUR HAND FUNCTION ON YOUR
ZOOM, AND IF WE CAN PULL THAT
UP, THAT WOULD BE GREAT.
AND WE WILL ANSWER ANY QUESTIONS
THAT PEOPLE MAY POSE ABOUT
EVERYTHING THAT HAS BEEN COVERED
TODAY.
THE WAY THIS WORKS, IF YOU DON'T
ASK US QUESTIONS, WE START
ASKING YOU QUESTION, SO YOU
PROBABLY WANT TO BE PROACTIVE
HERE AND PREVENT A LECTURE ABOUT
THE KREBS CYCLE.
RUSS, PLEASE, YOU'RE UP.
>> THANK YOU.
FIRST THANK YOU FOR THE
PRIVILEGE OF AD HOCING.
LET ME JUST EXPRESS MY
APPRECIATION TO THE DIRECTOR FOR
THE OUTSTANDING LEADERSHIP OVER
THE PAST FEW YEARS OF THE NIH,
WHICH IS GREATLY APPRECIATED BY
OUR ENTIRE COMMUNITY.
I HAVE TWO QUESTIONS.
ONE A BROAD ONE, ONE IS A
NARROWER ONE.
THE BROAD ONE IS A MECHANISTIC
QUESTION AND IT'S REALLY ABOUT
HOW ANY REORGANIZATION OF NIH
WOULD PROCEED.
THERE IS THE PRESCRIBED
MECHANISM FOR MAKING
RECOMMENDATIONS WHICH GOES
THROUGH THE SCIENTIFIC
MANAGEMENT REVIEW BOARD, WHICH
IS NOW RECONVENED, AND THEN
THERE'S THE CONGRESSIONAL
PROCESSES FOR APPROPRIATIONS,
WHICH AS YOU NOTED THIS YEAR,
HAD APPROPRIATIONS IN THE HOUSE
BILL FOR A MAJOR REORGANIZATION
WHICH DID NOT HAVE THE SAME
PROCESS IN TERMS OF COMMITTEE
EVALUATION AND FORMAL
RECOMMENDATIONS.
HOW ARE THOSE TWO PROCESSES
INTERDIGITATED?
>> SO I CAN ANSWER THIS AND THEN
I ALWAYS HAVE LARRY HERE TO
CORRECT ME IF I GET ANY OF THIS
WRONG, BUT YOU KNOW, OUR
INSTITUTES AND CENTERS ARE
DESIGNATED BY CONGRESS.
THEY HAVE THE -- THEY HAVE THE
AUTHORITY.
AND SO SOMETHING LIKE -- I'LL
JUST GIVE YOU AN EXAMPLE OF
SOMETHING THAT WE ACTUALLY HAVE
PROPOSED RIGHT NOW, AND WE'RE
WAITING TO SEE IF WE GET THE
RESULT, WE WOULD LIKE TO CHANGE,
FOR INSTANCE, THE NAME OF ONE OF
OUR INSTITUTES AND CENTERS.
EVEN CHANGING THE NAME, THIS IS
THE NICHD WE WOULD LIKE TO
CHANGE THE NAME OF THE NATIONAL
INSTITUTE OF CHILDHOOD HEALTH
AND DEVELOPMENT, TO ACKNOWLEDGE
ITS ALSO CRITICAL ROLE IN
WOMEN'S HEALTH AND FURTHERING
WOMEN'S HEALTH.
AND EVEN DOING THAT, A NAME
CHANGE, HAS GOT TO BE APPROVED
BY CONGRESS.
SO THE ADVISORY COMMITTEE TO THE
DIRECTOR IS DESIGNED TO BRING
EXPERTS CONTENT, EXPERTS IN WHAT
WE DO TO GIVE PROPOSALS TO THE
DIRECTOR WHICH THEN WILL BE --
WHICH WILL THEN BE TRANSMITTED
TO CONGRESS AS REQUESTS.
>> OKAY.
THANK YOU.
>> AND KATE, I DON'T KNOW IF YOU
HAVE ANYTHING IN ADDITION TO
ADD.
THE SMRB WAS RECONVENED IN PART
BECAUSE THE NIH DIRECTOR THOUGHT
THIS WOULD BE A VERY VALUABLE
TOOL, AND IN PART BECAUSE THE
CONGRESS ALSO ASKED US TO
RECONVENE.
SO IT'S OUR HOPE THAT THE
CONGRESS WILL BE INFORMED BY THE
DELIBERATIONS OF THE SMRB, BUT
AS THE NIH DIRECTOR HAS SAID,
OBVIOUSLY IT'S ULTIMATELY THE
CONGRESS' ROLE.
KATE, ANYTHING TO ADD TO THAT?
>> NO, I GUESS I WOULD JUST --
THE ONLY THING I WOULD ADD IS
NEXT YEAR IN THE 119TH CONGRESS,
WE DO EXPECT THERE TO BE SOME
CONTINUED INTEREST IN NIH
RE-AUTHORIZATION, AND I THINK
THE TOPIC OF CONSOLIDATION COULD
COME UP AGAIN.
I EXPECT THERE WILL BE A PRETTY
ROBUST PROCESS, BIPARTISAN,
BICAMERAL, TO DISCUSS ANY
CHANGES IF THERE ARE ANY THAT
CONGRESS WOULD WANT TO PURSUE.
I THINK THEY DO WANT THE
RECOMMENDATIONS FROM THE SMRB TO
INFORM THAT PROCESS.
YOU KNOW, BOTH THE HOUSE AND THE
SENATE, AND ENERGY AND COMMERCE,
HAD A REQUEST FOR INFORMATION.
SO THEY WERE SEEKING INPUT FROM
NIH PARTNERS ACROSS THE SPECTRUM
AS WELL.
SO MUCH MORE TO COME, BUT IT
WILL BE A LONGER TERM, I HOPE
BIPARTISAN PROCESS WITH INPUT
FROM MANY PARTNERS BEFORE
CONGRESS ULTIMATELY DECIDES
WHETHER THEY WOULD WANT TO MAKE
ANY CHANGES.
>> EXCELLENT.
THANK YOU.
THE SECOND QUESTION IS ABOUT THE
TRUSTED DATA REPOSITORY WITHIN
HHS, AND I THINK THIS IS A
PHENOMENAL OPPORTUNITY.
WITHIN OUR LITTLE FIELD OF
OPHTHALMOLOGY, WE HAVE A
REGISTRY WHICH DEVELOPED REALLY
OUT OF A CMS COLLABORATION
CALLED IRIS, WHICH IS A TRUSTED
BROKER FOR QUALITY OF CARE DATA
TO GO FORWARD TO CMS, AND HAS
BEEN WILDLY SUCCESSFUL.
WE HAVE ALMOST 700 MILLION
PATIENT VISITS AND 75 MILLION
PATIENTS IN THIS REGISTRY, ALL
OF WHOM HAVE AGREED TO HAVE
THEIR DE-IDENTIFIED DATA BE USED
FOR REAL WORLD STUDIES.
IN LOOKING AT EXPANDING THIS,
THE TRIPPING POINT ENDS UP BEING
DATA INTEROPERABILITY, AND IN
PARTICULAR, DICOM-TYPE STANDARDS
SO THAT EVERYONE'S DATA CAN BE
HARMONIZED.
RECENTLY THE NEI, THE FDA, AND
THE ONC ALL CAME TO AGREEMENT ON
STANDARDS THAT WOULD ENSURE
INTEROPERABILITY, BUT CMS WAS
NOT IN THAT DISCUSSION, AND
ULTIMATELY IN THE REAL WORLD,
CMS IS WHERE THE RUBBER MEETS
THE ROAD IN THAT AN
OPHTHALMOLOGIST JUST BUYING A
PIECE OF EQUIPMENT NEEDS TO GET
REIMBURSED FOR THEIR SERVICES,
IF CMS SAID IT HAS TO BE A DICOM
COMPLIANT PIECE OF EQUIPMENT, IT
WOULD HAPPEN TOMORROW.
IS THIS NEW SORT OF HHS WIDE
TRUSTED BROKER THE PLACE WHERE
THESE SORTS OF DISCUSSIONS WILL
HAPPEN?
>> SO, NO, BUT LET ME JUST BE
VERY CLEAR.
THE TRUSTED BROKER IS AN
ORGANIZATION THAT IS AN
AFFILIATE.
FOUNDATION FOR THE NIH.
IT IS INTENTIONALLY DESIGNED TO
BE OUTSIDE OF GOVERNMENT, BUT TO
BE RESPONSIVE TO GOVERNMENT
REQUEST.
OKAY, SO THAT'S IMPORTANT.
AND IT'S BASICALLY -- I THINK
THIS MATTERS A LOT.
IT IS INTENDED TO BE AN EXTRA
LEVEL OF SECURITY BETWEEN ANY OF
US WHEN WE WALK INTO OUR
DOCTOR'S OFFICE AND SAY YES, YOU
CAN HAVE MY DATA FOR RESEARCH,
AND IN SOME CASES EVEN, MAYBE
YOU CAN IDENTIFY ME BECAUSE I
WANT TO BE CONTACTED IF SOME
OPPORTUNITY COMES.
IT'S DESIGNED TO BE AN
ADDITIONAL BUFFER THAT WILL
ENSURE EXTRA SECURITY FOR THAT
INTERACTION.
BASICALLY BETWEEN
FEDERAL GOVERNMENT USE OF DATA
OR REALLY ANYBODY USE OF DATA,
AND THE PRIMARY TREATING
INSTITUTION.
SO THAT'S WHAT THE TRUSTED
BROKER IS.
NOW, THE PROGRAM, THE EFFORT
WITHIN GOVERNMENT TO USE DATA
THAT IS NEEDED BY GOVERNMENT
SUCH AS CMS, CDC, FDA, THAT IS
AN EFFORT THAT HAS BEEN
SPEARHEADED BY NIH UNDER THE
ROOF OF THE NATIONAL LIBRARY OF
MEDICINE, AND THAT IS WHERE THE
DATA STANDARDS, THE APPROACHES,
THE INTEROPERABILITY PLANS, ALL
OF THAT IS BEING DEVELOPED.
SO THAT IS BEING DEVELOPED NOT
IN THE BROKER, THE BROKER IS
JUST MAKING SURE EVERYTHING
HAPPENS PROPERLY.
THEN LAST OF ALL I WANT TO SAY
THAT -- AND YES, CMS ABSOL ABSOY
AT THE TABLE.
AS YOU SEE, FOR ONCOLOGY, CMS IS
AT THE TABLE.
THEY'RE NOT AT THE TABLE LATE.
THEY'RE AT THE TABLE AT THE VERY
BEGINNING AS WE DEVELOP THE USE
CASES TO DEVELOP THE STANDARDS,
AND WE THINK THAT BEING THERE
FROM THE VERY BEGINNING IS VERY
HELPFUL IN GETTING ENGAGEMENT
ACROSS ALL THE AGENCIES.
LAST OF ALL, I JUST WANT TO
CONGRATULATE THE OPHTHALMOLOGY
COMMUNITY.
YOU WERE THE FIRST.
I THINK WE CAME ALONG WITH NCODE
AFTERWARD BUT WE WERE WATCHING
YOU VERY CAREFULLY.
THIS IS NOW ALMOST A DECADE AGO,
AND THE OPHTHALMOLOGY COMMUNITY
I WILL SAY IS THE FIRST AND BEST
IN CLASS IN GETTING A COMMUNITY
OF CLINICIANS BEHIND MAKING THIS
A REALITY FOR EVERYBODY, SO
THANK YOU.
>> THANK YOU.
>> OTHER QUESTIONS OR COMMENTS,
PLEASE?
IF YOU COULD RAISE YOUR HAND.
YES, COREY.
>> YES.
GOOD MORNING.
I DON'T HAVE A QUESTION, BUT I
WOULD LIKE TO MAKE A COMMENT.
LET ME GIVE FIRST A PHYSICAL
DESCRIPTION FOR INDIVIDUALS WHO
MAY BE VISUALLY IMPAIRED.
I AM AN AFRICAN AMERICAN MIDDLE
AGED MALE AND I HAVE ON A
STRIPED DRESS SHIRT WITH A
BACKGROUND OF BLUE AND ORANGE.
AND SO IN TERMS OF -- IN
RESPONSE TO THE DIRECTOR'S
REPORT THIS MORNING REGARDING
THE MISSION CHANGE, AS
RECOMMENDED BY THE SUBCOMMITTEE
ON INDIVIDUALS WITH
DISABILITIES, I WOULD LIKE TO
ACKNOWLEDGE THE OUTSTANDING WORK
THAT THE NIH IS DOING IN ORDER
TO ENGAGE THE DISABILITY
COMMUNITY TO GATHER INFORMATION
FROM THAT COMMUNITY IN TERMS OF
THEIR PERSPECTIVES AROUND THE
MISSION CHANGE, AND IN
PARTICULAR, THE VIRTUAL
ROUNDTABLE DISCUSSIONS, I THINK
HAVE BEEN REMARKABLE IN TERMS OF
GATHERING THESE PERSPECTIVES.
AND I MYSELF HAD AN OPPORTUNITY
TO PARTICIPATE ON ONE OF THESE
ROUNDTABLES ON NOVEMBER THE
12TH, AND I FELT LIKE THE
ENGAGEMENT WAS OUTSTANDING.
SO I AM -- I'M VERY IMPRESSED
WITH WHAT THE NIH IS DOING IN
ORDER TO REACH THE DISABLED
COMMUNITY FOR THEIR
PERSPECTIVES, BECAUSE WE
UNDERSTAND THAT THE OPPOSITION
IN PARTICULAR TO THIS MISSION
CHANGE HAS BEEN SOMEWHAT STRONG,
SO I THINK IT'S CRITICAL THAT WE
ALL CONTINUE TO GET FEEDBACK
FROM THE COMMUNITY IN TERMS OF
THE DISABILITY COMMUNITY IN
ORDER TO MAKE A FINAL DECISION
AROUND THE MISSION STATEMENT.
SO I JUST WANTED TO MAKE THAT
COMMENT.
THANK YOU.
>> THANK YOU SO MUCH, COREY.
I REALLY APPRECIATE IT.
AND I JUST HAVE TO SAY THAT THIS
IS A THEME ACROSS EVERYTHING
THAT WE'RE DOING, IS SERIOUSLY
ENGAGE WITH PEOPLE WE SERVE, AND
I WILL SAY I BELIEVE IT WILL
BRING BENEFIT TO THE PEOPLE WE
SERVE BUT, OH, IT IS JUST SUCH A
POSITIVE FOR US AS WELL.
WE ARE SO MUCH SMARTER, MORE
ABLE TO GIED THE RESEA GUIDE THA
POSITIVE DIRECTION FOR
EVERYBODY, AND I'M JUST REALLY
GLAD TO SEE THAT THIS HAS NOW
BECOME A ROUTINE ASPECT OF OUR
CULTURE, ESPECIALLY WHEN IT
COMES TO SOLVING CLINICAL
PROBLEMS FOR PEOPLE, WE ACTUALLY
ASK THEM WHAT THAT MEANS TO THEM
AND WHAT THEY WANT TO SEE.
IT'S NOW A PART OF THE CULTURE,
AND I THINK IT'S SO INCREDIBLY
POSITIVE.
>> TARA, YOU AND YOUR TEAM HAVE
BEEN DRIVING THIS.
DO YOU WANT TO ADD ANYTHING IN
ADDITION?
>> NO, FIRST OF ALL THANK YOU,
COREY, FOR THE POSITIVE
FEEDBACK.
AND WE'LL DISCUSS A LITTLE BIT
MORE ABOUT SOME OF THE
ACTIVITIES THAT WE'RE DOING THIS
AFTERNOON, SO YOU'LL HEAR.
EVEN FURTHER THEN ABOUT THESE
ROUNDTABLES, SOME OF THE
FEEDBACK THAT WE GOT, AND OUR
NEXT STEPS AS WE THINK ABOUT
THIS FURTHER.
>> THANK YOU.
TESHIA, YOU'RE NEXT, PLEASE.
>> THANK YOU.
I WANT TO FOLLOW ON COREY'S
STATEMENT OF APPRECIATION FOR
REACHING OUT TO SPECIFICALLY THE
INFORMATION YOU SAID ABOUT
REACHING OUT TO THE NATIVE
COMMUNITIES.
I APPRECIATE THAT.
AND WITH THAT AND THE WORK THAT
YOU'RE DOING IN WORKING WITH THE
DISABILITY COMMUNITY, I'M NOT
SURE WHAT THE PROPER LANGE SJ
THLANGUAGE ISTHERE, PLEASE FORGI
WANT TO KNOW HOW WE ARE GOING TO
MAINTAIN THE STRIDES THAT YOU'VE
MADE IN DIVERSIFYING ACROSS THE
NIH, NOT JUST IN THOSE KINDS OF
COMMUNITIES, BUT IN THE WAY YOU
ARE REACHING OUT THROUGH
DIFFERENT MECHANISMS, AND ALSO
THE DIVERSITY AND THE KINDS OF
RESEARCH THAT IS DONE.
SO RESEARCH IS DONE IN PLACE AND
DIVERSIFYING THE PLACE,
DIVERSIFYING THE PEOPLE,
DIVERSIFYING THE MECHANISMS.
ALL OF THAT HAS BEEN REALLY
IMPORTANT IN TRYING TO ADDRESS
HEALTH EQUITY THROUGH SYSTEMS
APPROACHES, NOT JUST OTHER KINDS
OF APPROACHES.
SO WHAT'S THE PICTURE LOOK LIKE
IN ORDER TO BE ABLE TO MAINTAIN
THAT WITH THE CHANGES THAT ARE
COMING IN THE ADMINISTRATION?
>> SO I REALLY BELIEVE THAT ANY
ADMINISTRATION CAN GET BEHIND
OUR GOAL OF SERVING THE PEOPLE
WHO NEED US.
CERTAINLY THAT'S BEEN MY
EXPERIENCE WITH EVERYONE I'VE
INTERACTED WITH IN CONGRESS ON
BOTH SIDES OF THE AISLE.
SO OUR FOCUS IS SERVING THE
PEOPLE WHO NEED US, THAT'S
NUMBER ONE.
AND THEN NUMBER TWO, I THINK
THERE IS A CRITICAL ELEMENT HERE
ABOUT THAT ENGAGEMENT WITH THE
PEOPLE AND COMMUNITIES THAT NEED
US.
IT'S GOT TO BE SUSTAINED.
SO IT'S GOT TO BE BUILT INTO THE
FABRIC OF WHAT WE'RE DOING.
THIS IS WHY, FOR INSTANCE, SOME
OF OUR REAL SIGNATURE
INITIATIVES NOW, YOU KNOW, NICHE
TICHS INITIATIVES RIGHT NOW THAE
NEW, CARE FOR HEALTH, INTENDS TO
BE IN EVERY COMMUNITY IN THE
UNITED STATES THAT NEEDS IT.
IT'S IN PILOT PHASE NOW, AND IT
WILL EXPAND.
EVERYBODY WHO'S GOT -- WHO IS
EXPERIENCING A HEALTH DISPARITY,
WHO HAS A PRIMARY CARE DOCTOR,
THAT'S WHERE WE WANT TO BE.
IT'S IN PILOT.
AND WE'VE GOTTEN GREAT RESPONSE
FROM BOTH SIDES OF THE AISLE IN
CONGRESS TO OUR CARE FOR HEALTH
INITIATIVE.
THE SAME THING ABOUT THE DATA.
DATA HAS TO INCLUDE EVERYBODY.
ESPECIALLY IN THE WORLD OF A.I.,
WE KNOW THAT IF WE DON'T HAVE
DATA FROM EVERYONE WHO WE NEED
TO SERVE, WE'RE GOING TO FAIL.
SO THAT, I BELIEVE, IS BUILT
INTO THE FABRIC OF WHAT WE'RE
DOING.
SO I THINK THAT'S OUR APPROACH,
AND IT'S MET WITH GREAT
ACCEPTANCE ON BOTH SIDES OF THE
AISLE TODAY, AND THAT'S WHAT I
EXPECT TO CONTINUE TO SEE.
>> JUST A FOLLOW-UP TO THAT.
I THINK ALSO THE CROSS
COMMUNICATION WITH OTHER HHS
ENTITIES AND THE WORK TO TRY AND
MAKE THE EXPERIENCE FOR THE
PATIENT AT THE HEALTHCARE LEVEL,
AND THAT INFORMATION, ALONG WITH
JUST INTEGRATING ALL THAT, MINE,
ITIMEAN, IT'S A REALLY SMART MO,
SO THANK YOU FOR ALL THAT.
>> THANK YOU.
OTHER COMMENTS OR QUESTIONS FROM
THE GROUP, PLEASE?
SO PLEASE, LUCILE.
>> RELATED TO THE A.I. AND HOW
THE DATA NEED TO BE DIVERSE,
COULD YOU COMMENT ALSO ON THE
DIVERSITY OF THE RESEARCHERS OR
THE DATA SCIENTISTS, INCLUDING
DIVERSITY OF BACKGROUNDS,
MEANING COMPUTER SCIENCE,
MATHEMATICS, STATISTICS, AND SO
ON?
AND I SAW YOUR TRAINING EFFORTS
ARE EXCELLENT, SO I WANT TO
CONGRATULATE YOU ON THAT AS
WELL.
HOW DO YOU SEE US MOVING
FORWARD, GIVEN THE SPECIALTIES
NOW GO WAY BEYOND MEDICINE AND
BIOLOGICAL SCIENCES.
>> OH, ABSOLUTELY.
THIS IS A REALLY GREAT QUESTION,
BECAUSE CLEARLY, AND I THINK
HAPPILY, THIS IS NOT SOMETHING
THAT NIH CAN DO ALONE, OKAY?
WE NEED TO BE PARTNERS NOT
ONLY -- CERTAINLY ACROSS
GOVERNMENT IN THE HEALTH SPACE
TO MAKE SURE THAT WE HAVE THE
VERY WIDE SPECTRUM OF
INDIVIDUALS WORKING ON THESE
ISSUES, AND THEN ALSO -- NOT
ONLY WITHIN GOVERNMENT, BUT ALSO
INDUSTRY, NON-PROFITS, AND
COMMUNITIES.
SO IT REALLY -- DOING THIS
PROPERLY IS GOING TO TAKE
EVERYONE.
THE APPROACH IS TO HAVE IT OPEN
AND TRANSPARENT AND CLEARLY
DEFINED PROCESS WHERE ALL CAN
ENGAGE IN THIS ACTIVITY.
YOU KNOW, WHAT'S HAPPENED A
LITTLE BIT NOW, IF YOU'RE
SPECIFICALLY TALKING ABOUT DATA
FROM INDIVIDUALS, IS IT'S JUST
BEEN INCREDIBLY FRAGMENTED, AND
THE FRAGMENTATION HAS LED TO
LACK OF INTEROPERABILITY AND
LACK OF ACCESS.
WE'VE NOW HAD LEGISLATION THAT
HAS BEEN AROUND FOR A GOOD WHILE
THAT HAS CALLED ON US TO ACHIEVE
THE KIND OF UNIVERSAL
INTEROPERABILITY THAT WE NEED,
SO WE ALREADY HAVE THAT.
AND NOW WE JUST NEED TO BRING
THE USER COMMUNITY THERE TO TAKE
TO THE NEXT LEVEL WHERE WE CAN
ACTUALLY USE THE DATA.
SO YOU'VE HIT IT JUST RIGHT,
THAT USER COMMUNITY CANNOT JUST
BE INDIVIDUALS SITTING AT NIH,
OF COURSE WE HAVE TO HAVE THE
FULL SPECTRUM OF EVERYONE THAT'S
NEEDED.
DATA SCIENCE, TECHNOLOGY, PEOPLE
WHO UNDERSTAND WHAT IT MEANS TO
WALK INTO A DOCTOR'S OFFICE AND
ANSWER A QUESTIONNAIRE.
WE NEED ALL OF THAT SPECTRUM
BROUGHT BEAR TO THIS.
AND -- BUT WE NOW HAVE THE
STRUCTURES AND THE ABILITY FOR
EVERYONE WHO'S INTERESTED IN
THAT TO BE ABLE TO ENGAGE.
PROBABLY HAVEN'T ANSWERED YOUR
QUESTION COMPLETELY BECAUSE THIS
NEEDS TO BE A LONG-TERM
COMMITMENT, BUT WHAT I'M TELLING
YOU IS, WE NOW VL T HAVE -- THEE
IS SET, THE ABILITY TO ENGAGE IS
THERE AND NOW WE CAN PULL IN WHO
WE NEED.
>> THANK YOU SO MUCH.
>> MAYBE TARA, I KNOW YOUR
OFFICE, ONE OF THE OFFICES IN
YOUR DIVISION HAS MADE GOOD
STRIDES IN THIS DIRECTION.
MAYBE IF YOU COULD QUICKLY
SUMMARIZE THAT.
>> WELL, JUST TO COMMENT A
LITTLE BIT ON THE TRAINING THE
WORKFORCE COMPONENT THAT WAS
MENTIONED, AND I THINK YOU WERE
CONGRATULATING US FOR SOME OF
OUR PROGRAMS AND I THINK WE'VE
MADE A LOT OF -- WE'VE PUT A LOT
OF FOCUS ON TRYING TO INVEST
FURTHER IN THE TRAINING
COMPONENT BECAUSE WE NEED THE
PEOPLE TO BE ABLE TO HAVE THE
BACKGROUND AND EXPERTISE NEEDED
TO LAUNCH SOME OF THESE
PROGRAMS, AND THAT'S AN AREA
THAT WE NOTED SEVERAL YEARS AGO,
WE NEEDED TO INVEST FURTHER.
AND SO THAT WOULD BE THE ONLY
ADDITIONAL POINT THAT I WOULD
ADD ON TOP OF WHAT MONICA HAD
INDICATED, AND WE'RE ALWAYS
LOOKING FOR ADDITIONAL FEEDBACK
IN HOW WE CAN CONTINUE TO BUILD
AND GROW THAT COMMUNITY FURTHER,
BRING IT TOGETHER, TRY TO WORK
ACROSS THE VARIOUS DISCIPLINES
EVEN FURTHER.
>> AND WE'RE CERTAINLY LOOKING
FORWARD TO THE OUTPUT OF YOUR
WORKING GROUP TO HELP US -- HELP
GUIDE US IN DOING THIS, YOU
KNOW, SO THANK YOU FOR AGREEING
TO TAKE THAT ON.
>> OKAY.
OTHER QUESTIONS OR COMMENTS,
PLEASE, FROM THE GROUP?
I THINK NO ONE HAS HAD THEIR
MORNING COFFEE YET.
>> WELL, LET'S GO HAVE MORNING
COFFEE.
>> IF THERE ARE NO FURTHER
COMMENTS OR QUESTIONS, WE'RE
GOING TO RECONVENE AT 11:15,
BECAUSE WE NEED TO STAY TRUE TO
THE SCHEDULE, WHICH IS IN THE
FEDERAL REGISTER NOTICE, AND
THERE MAY BE PEOPLE WHO ARE
SPECIFICALLY GOING TO BE TUNING
IN FOR THE NEXT PRESENTATION SO
WE DON'T WANT TO JUMP AHEAD.
SO WE'LL RECONVENE AT 11:15.
THANKS, EVERYBODY.
OKAY, WELL, HELLO, EVERYBODY.
SO WE'RE GOING TO TALK ABOUT
RECOVER.
AND SO I AM GOING TO INTRODUCE
DR. SARAH READ.
HOW WE'RE GOING TO DO THIS IS
DR. READ IS GOING TO TALK ABOUT
THE NEW ITERATION OF RECOVER
THAT BEGAN LAST MAY OR SO, THE
NEW KIND OF RESETTING WE HAD,
SOME OF THE RECOVER ACTIVITIES.
SO SHE'S GOING TO DO THAT FIRST,
AND AFTER SHE DOES THAT, I'LL
GIVE A PROGRESS REPORT ON THE
OTHER ONGOING IMPORTANT
ACTIVITIES BEHIND RECOVER.
SO WITHOUT FURTHER ADO, LET ME
TURN THIS OVER TO DR. SARAH
READ.
>> THANK YOU.
I JUST WANT TO CONFIRM THAT YOU
CAN HEAR ME?
>> YOU'RE GOOD.
>> GREAT.
THANK YOU.
WELL, GOOD MORNING, EVERYONE,
AND THANK YOU, DR. BERTAGNOLLI,
FOR THE INVITATION TO SPEAK THIS
MORNING ABOUT OUR NEW
INITIATIVE, WHICH IS CALLED
RECOVER, TREATING LONG COVID, OR
RECOVER TLC FOR SHORT.
THIS IS AN INITIATIVE FOCUSED ON
CONCEPTUALIZING AND LAUNCHING
THE NEXT ROUND OF NIH SUPPORTED
CLINICAL TRIALS TO EVALUATE
THERAPEUTIC INTERVENTIONS FOR
LONG COVID.
AND IMPORTANTLY, BUILDS OFF THE
LEARNINGS AND EXPERIENCE OF THE
RECOVER INITIATIVE.
I'M FILLING IN FOR DR. GINA PLAT
SEW, DIRECTOR OF NIAID, WHO IS
CO-CHAIRING A DIFFERENT MEETING
TODAY BUT JUST TO SAY SHE'S A
REAL CHAMPION OF THIS PROGRAM
AND I HOPE TO CHANNEL HER
ENTHUSIASM AND CONVEY HER
VISION.
I'M NOT GOING TO GO TOO MUCH
INTO THE BACKGROUND OF LONG
COVID, BUT IT IS COMPLICATED AND
WE HAVE MUCH TO LEARN STILL.
IT COVERS A WIDE SPECTRUM OF
CLINICAL SYMPTOMS AND INVOLVES
MANY DIFFERENT ORGAN SYSTEMS
AND, AS SUCH, REQUIRES A
MULTIDISCIPLINARY APPROACH TO
STUDYING IT AND POTENTIALLY
TREATING IT.
IT CAN AFFECT THE CARDIOVASCULAR
SYSTEM, PULMONARY SYSTEM,
NEUROLOGIC SYSTEM, ET CETERA,
AND THERE ARE MYRIAD OF SYMPTOMS
WITH VARYING PHYSIOLOGY AS A
RESULT.
LONG COVID IS NOT JUST ONE THING
AND WE NEED TO BE ABLE TO
UNDERSTAND THE CLINICAL
PHENOTYPES IN A WAY THAT'S
RELEVANT TO BE ABLE TO
INTERVENE.
AND IN TERMS OF WHAT DRIVES LONG
COVID, WE STILL HAVE A LOT TO
LEARN THERE AS WELL.
IS THERE A RESERVOIR, COULD
THERE BE REACTIVATION OF VIRUS,
AND WHAT LEADS TO MITOCHONDRIAL
DYSFUNCTION, EFFECTS ON THE
MICROBIOME, VASCULAR
INFLAMMATION AND SO ON, ALL OF
WHICH THEN LEAD INTERNALLY TO
TISSUE DYSFUNCTION AND DAMAGE.
IT'S VERY COMPLEX, THERE'S NOT
ONE PHENOTYPE AND WE HAVE TO BE
FLEXIBLE TO UNDERSTAND THE
PATHOBIOLOGY.
AND WHAT ABOUT THE PREVALENCE OF
LONG COVID?
IT'S QUITE HARD TO MEASURE AND
VARYING DEFINITIONS.
ACCORDING TO THIS REPORT IN
JAMA, IN SOME POPULATIONS IT
COULD BE AS HIGH AS 10%.
THE CDC HAS AN ESTIMATE OF UP TO
6.8% OF ADULTS IN THE U.S. ARE
CURRENTLY EXPERIENCING LONG
COVID AND REGARDLESS OF WHAT THE
EXACT NUMBER IS, THIS REPRESENTS
A HUGE BURDEN.
WHEN WE'RE TALKING ABOUT 5 TO
10% OF JUST THE U.S. POPULATION
ALONE, THESE ARE REALLY LARGE
NUMBERS.
AND THERE'S A LOT MORE THAT'S
NOT EASILY MEASURED THAT'S
UNACCOUNTED FOR IN THESE
EPIDEMIOLOGIC DATA.
THERE ARE SEVERAL LINES OF
INVESTIGATION UNDER WAY THROUGH
RECOVER AND OTHER EFFORTS
LOOKING AT THE ORIGINS OF THE
PATHOGENESIS OF LONG COVID.
WE HAVE SOME M MODELS WE CAN USE
FROM OTHER INFECTION ASSOCIATED
CHRONIC CONDITIONS THAT ARE
ASSOCIATED WITH EPV, FOR
EXAMPLE, IN WHICH THERE MIGHT BE
VIRAL REACTIVATION, THERE COULD
BE PERSIST 10 OF INFECTION IN
THE FORM OF PROTEINS THAT CAUSE
ONGOING IMMUNE STIMULATION.
THERE COULD BE DYSREGULATION OF
THE IMMUNE REACTIONS ONGOING,
PERSISTENCE OF ABERRANT IMMUNE
RESPONSES CAUSING
AUTOANTIBODIES, AUTOIMMUNE
DISEASE AND SO ON AND ALL OF
THESE ARE VERY ACTIVE AREAS OF
INVESTIGATION THROUGH THE
RECOVER PROGRAM AND OTHER
EFFORTS FOR WHICH WOULD HE LIKE
TO TAKE ADVANTAGE OF THE WORK
THAT'S BEEN DONE AND IS ONGOING
IN ORDER TO INFORM THE NEXT
ROUND OF CLINICAL TRIALS,
POTENTIALLY LOOKING AT POTENTIAL
THERAPEUTICS FOR INTERVENING
WITH LONG COVID.
SO THE INITIATIVE THAT WE'RE
TALKING ABOUT TODAY IS AN EFFORT
TO BUILD ON EVERYTHING THAT
RECOVER HAS DONE, AND IN AN
EFFORT ULTIMATELY TO GET
SOLUTIONS TO PEOPLE WHO NEED
THEM.
WE WANT TO LOOK TO ALL THE WORK
DONE IN THE RECOVER PROGRAM
THROUGH COHORT, PATHOGENESIS
STUDIES AND CLINICAL TRIALS TO
UNDERSTAND THE PHYSIOLOGY AND
THE DRIVERS OF THE DISEASE IN
ORDER TO INTERVENE IN A RATIONAL
WAY.
SO WHAT HAVE WE COME UP WITH?
THE NIH RECOVER TLC INITIATIVE,
THE GOAL OF THIS IS TO DEVELOP
SAFE AND EFFECTIVE THERAPEUTIC
INTERVENTIONS FOR LONG COVID,
AND TO PROVIDE THESE TO
HEALTHCARE PROVIDERS AND
PATIENTS AS RAPIDLY AS POSSIBLE.
AND WE'VE COME UP WITH FOUR
SCIENTIFIC AIMS THAT ARE SORT OF
UNDERPINNING THIS INITIATIVE.
MAINLY TO IDENTIFY PHARMACOLOGIC
AND/OR NON-PHARMACOLOGIC
INTERVENTIONS TO TREAT LONG
COVID, TO AGAIN BUILD FROM THE
FINDINGS OF THE RECOVER COHORT,
PATHOBIOLOGY STUDIES AND
CLINICAL TRIALS, AND DEVELOP
RAPID, NIMBLE CLINICAL TRIALS
DESIGN WITH DIRECT AND
TRANSPARENT ENGAGEMENT WITH ALL
OF THE STAKEHOLDERS, SCIENTIFIC,
INDUSTRY, PATIENT COMMUNITIES
AND SO ON.
AND ULTIMATELY TO PROVIDE ACCESS
AND SHARING OF DATA WITH THE
PUBLIC AND THE SCIENTIFIC
COMMUNITIES AS WE PROCEED.
THERE ARE FOUR GUIDING
PRINCIPLES THAT WE WILL TURN TO
WHEN WE'RE WORKING ON THIS
INITIATIVE.
WE REALLY WANT THIS EFFORT TO BE
PATIENT-CENTERED AND TO THINK OF
PATIENTS AND PARTICIPANTS AS OUR
PARTNERS, AND THAT MEANS IN
EVERY STEP OF THE WAY, AND SO WE
HAVE RIGHT FROM THE BEGINNING
ENGAGED WITH PEOPLE WHO ARE
LIVING WITH LONG COVID.
WE WANT TO BE INCLUSIVE AND HAVE
DIVERSE PARTICIPATION ON A
NATIONAL SCALE, AGAIN ENGAGING A
VERY DIVERSE COMMUNITY OF PEOPLE
WHO ARE EXPERIENCING THE
CONSEQUENCES OF LONG COVID,
WHETHER THEY'RE LIVING WITH IT
OR THEY'RE CARING FOR PEOPLE
WITH IT.
WE'RE HOPING TO DEVELOP PLATFORM
PROTOCOLS WITH STANDARDIZED
METHODOLOGY AND COMMON DATA
ELEMENTS IN ORDER TO BE NIMBLE
AND TO BE ABLE TO ACCOMMODATE
NEW THERAPEUTIC CANDIDATES AS
THEY COME UP IN A SEAMLESS
FASHION.
AND WE WANT TO BE ADAPTIVE, BOTH
IN OUR CLINICAL TRIAL DESIGNS
AND IN OUR ACCOMMODATION OF
EMERGENT SCIENCE, WE WANT TO
STOP THINGS THAT AREN'T WORKING
AS QUICKLY AS WE CAN, AND TAKE
IN NEW POTENTIAL CANDIDATES AS
WE LEARN BOTH FROM OUR TRIALS
AND THE TRIALS THAT ARE GOING ON
IN OTHER EFFORTS.
SO WHY IS NIAID WELL SUITED TO
BE LEADING THIS EFFORT?
WE ARE VERY EXPERIENCED WITH
LARGE SCALE COMPLEX CLINICAL
TRIALS.
WE HAVE REGULATORY TEAMS THAT
HAVE DECADES LONGSTANDING
INTERACTIONS WITH THE FDA AND
EXPERIENCE ON HOW TO DEAL WITH
COMPLEX INDs, FOR EXAMPLE, AND
GET THINGS MOVING AS QUICKLY AND
SEAMLESSLY AS POSSIBLE.
WE HAVE ROBUST BIOSTATISTICAL
SUPPORT FOR CLINICAL TRIAL
DESIGN AND DATA ANALYSIS.
WE HAVE CONTRACTS IN PLACE FOR
PRODUCT SUPPORT AND CREATION OF
BOTH BIOSPECIMEN AND DATA
REPOSITORIES.
WE HAVE DSMB CAPABILITIES, BROAD
CONTRACT SUPPORT FOR ALL ASPECTS
OF CLINICAL TRIALS, INCLUDING
THINGS LIKE PHARMACY, SITE
MONITORING AND SO ON.
AND IMPORTANTLY, WE HAVE
LONG-STANDING RELATIONSHIPS WITH
SCIENTIFIC AND ADVOCACY
COMMUNITIES THROUGH OUR OTHER
LONG-TIME ONGOING EFFORTS IN
OTHER AREAS OF SCIENCE, NAMELY
FROM MY BACKGROUND IN PARTICULAR
IN THE HIV/AIDS AREA, WHERE WE
HAVE WORKED WITH COMMUNITY AND
SCIENTIFIC LEADERS FOR A VERY
LONG TIME AND HAVE DEVELOPED
MODELS THAT WE HOPE TO APPLY TO
LONG COVID AS WELL.
WE HAVE MEDICAL OFFICERS AND
PROGRAM STAFF WHO HAVE VERY
EXTENSIVE CLINICAL TRIALS
EXPERIENCE, AND MOST RECENTLY,
WE HAVE HAD EXPERIENCE IN THE
COVID ARENA IN THE NIH'S
RESPONSE TO ACUTE COVID THROUGH
THE ACTIVE PUBLIC-PRIVATE
PARTNERSHIP STOOD UP BY FRANCIS
COLLINS IN THE BEGINNING OF THE
COVID PANDEMIC, AND WE HOPE TO
REALLY LEVERAGE OUR EXPERIENCES
FROM THE ACUTE COVID RESPONSE AS
WELL AS OUR EXPERIENCES IN
HIV/AIDS AND OTHER AREAS WF
WE'VE HAD ONGOING CLINICAL
TRIALS TO TAKE LESSONS LEARNED
AND APPLY SORT OF THE BEST
STRATEGIES FROM THOSE PLAYBOOKS.
IN TERMS OF OUR APPROACH
OVERALL, WE REALLY WANT TO BE
ENGAGED SCIENTIFICALLY AGAIN.
WE PLAN TO AND HAVE ALREADY DONE
THIS TO ASSESS THE CURRENT
CLINICAL TRIALS LANDSCAPES, NOT
JUST WHAT'S BEING DONE WITHIN
RECOVER, BUT REALLY BROADLY
GLOBALLY IN THE AREA OF LONG
COVID SO THAT WE AREN'T
DUPLICATING EFFORTS AND WE'RE
NOT REINVENTING THE WHEEL.
SO WE WANT TO DETERMINE WHAT
APPROACHES ARE NEEDED FOR TRIALS
IN TERMS OF MAKING THEM AS
EFFICIENT AS POSSIBLE, AS ROW
ROBUST, AND MAKING SURE THAT WE
REALLY ACHIEVE THE END POINTS
THAT WE'RE LOOKING FOR BY DOING
A LANDSCAPE, BY TALKING TO
STAKEHOLDERS, AND REALLY
GLEANING FROM WHAT PEOPLE HAVE
LEARNED ALREADY.
AND WE WANT TO THEN IDENTIFY
LESSONS IN ORDER TO INFORM THE
PROTOCOL DESIGN AND THE LAUNCH
OF OUR PROGRAM.
HOW WILL RECOVER TLC WORK?
WE'VE ALREADY TAKEN A NUMBER OF
STEPS.
WE ACTUALLY STARTED FIRST
CONCEPTUALIZING THIS BACK IN
JULY AND REALLY KIND OF KICK
THINGS OFF IN SEPTEMBER, WHEN WE
ENIMAENGAGE THE FOUNDATION FOR S
A STRATEGIC PARTNER.
THIS REALLY HAS BEEN AN AMAZING
PARTNERSHIP EVEN IN THE FIRST
FEW MONTHS OF WORKING WITH THEM.
AGAIN WE'RE TAKING A LESSON
LEARNED FROM ACTIVE.
THEY WERE REALLY VERY
FOUNDATIONAL IN GIVING THE ACT
OF PUBLIC-PRIVATE PARTNERSHIP
GOING AND KEEPING THINGS ON
TRACK.
WE REALLY TOOK, AGAIN, A LESSON
FROM THAT PLAYBOOK IN ENGAGING
WITH THE FNIH AND THEY HAVE
REALLY BEEN FANTASTIC PARTNERS
ALREADY.
WE'RE ALSO ENGAGING WITH OTHER
ICs.
WE SEE THE NHLBI AND NINDS IN
PARTICULAR AS REALLY KEY
PARTNERS GIVEN OUR ROLE IN
LEADERSHIP WITH THE RECOVER
INITIATIVE, BUT ALSO INTEND TO
ENGAGE OTHER ICs AS NEEDED.
WE HAVE ALREADY HAD A KICKOFF
MEETING AT THE END OF SEPTEMBER
AND I'LL GO INTO MORE DETAIL
ABOUT THAT IN A MOMENT.
BUT THROUGH THAT INITIAL
MEETING, WE WERE ABLE TO
INTRODUCE THE STRUCTURE OF
RECOVER TLC TO VARIOUS
STAKEHOLDERS AND GET INPUT FROM
THEM AND THEN TAKE INTO ACCOUNT
THOSE COMMENTS AND THAT
FEEDBACK.
AS FAR AS THE STRUCTURE OF TLC,
IMPORTANTLY WE HAVE AN EXECUTIVE
COMMITTEE OVERSEEING THE ENTIRE
INITIATIVE.
THE IMPORTANCE HERE IS THAT
WE'RE ENGAGING WITH THE NIH
DIRECTOR, DR. BERTAGNOLLI, THE
DIRECTOR OF NIAID AS I'VE
MENTIONED, AS WELL AS THE
DIRECTORS OF NHLBI AND NINDS.
THE LEAD OF THE FNIH, AND ALSO
IMPORTANTLY WE'LL HAVE AGAIN
INPUT FROM THE COMMUNITY.
AND REALLY THIS IS SHOWING THAT
THIS IS AN EXTREMELY HIGH
PRIORITY AT NIH AND REALLY
TAKING OWNERSHIP AT THE HIGHEST
LEVEL FOR THE OUTPUTS OF THIS
INITIATIVE.
UNDER THE EXECUTIVE COMMITTEE,
WE'LL HAVE A SCIENTIFIC
OVERSIGHT COMMITTEE WHICH WE'VE
ALREADY BEEN PUTTING TOGETHER
THAT TAKES EXPERTISE FROM ACROSS
THE VARIOUS STAKEHOLDER GROUPS
INCLUDING WITHIN NIH BUT ALSO
WITHIN ACADEMIA.
WE HAVE INDUSTRY
REPRESENTATIVES, REPRESENTATIVES
FROM OTHER AGENCIES IN THE U.S.
GOVERNMENT, AND AGAIN WITH
COMMUNITY REPRESENTATION.
AMONG OTHER THINGS, THIS
COMMITTEE WILL BE RESPONSIBLE
FOR REVIEWING A LIST OF
PRIORITIZED THERAPEUTIC
INTERVENTIONS, AND MAKING
RECOMMENDATIONS FOR WHICH OF
THOSE INTERVENTIONS MAKES SENSE
TO STUDY IN CLINICAL TRIALS,
WHICH THEN WOULD BE SENT TO THE
EXECUTIVE COMMITTEE FOR A FINAL
SIGNOFF AND APPROVAL.
AND WE ALSO WILL BE PUTTING
TOGETHER A NUMBER OF WORKING
GROUPS THAT WILL BE MORE FOCUSED
ON INDIVIDUAL EITHER MECHANISMS
OR SYMPTOM-BASED WORKING GROUPS
DEPENDING ON WHAT THE QUESTION
IS THAT WE NEED TO ANSWER.
SO WITHIN THOSE WORKING GROUPS,
WE'VE PUT TOGETHER THE EXPERTISE
THAT WILL BE NEEDED TO EVALUATE
POTENTIAL THERAPEUTICS, AND
AGAIN, PRIORITIZE AND MAKE
RECOMMENDATIONS TO THE
SCIENTIFIC OVERSIGHT COMMITTEE.
AS FAR AS THE OPERATIONS, WE'RE
REALLY LOOKING TO LEVERAGE OUR
EXISTING RESOURCES.
AS I'VE MENTIONED, WE HAVE A
NUMBER OF RESOURCES THAT HAVE
BEEN IN PLACE AND HAVE REALLY
PROVEN TO WORK WELL AND WORK
EFFICIENTLY, SO WE'RE GOING TO
DO OUR BEST TO USE ALL THE
EXISTING RESOURCES THAT WE CAN
AS MUCH AS POSSIBLE AND WHERE
NEEDED.
WE WILL ENHANCE, SO TO SPEAK,
AND MAKE USE OF OTHER RESOURCES
ACROSS THE NIH.
REALLY THE OVERALL STRATEGY IS
TO INCREASE OUR EFFICIENCY AS A
WAY OF REFLECTING THE URGENCY
AND IMPORTANCE OF THIS PROBLEM.
I CAN'T UNDERSCORE ENOUGH THE
IMPORTANCE OF COMMUNITY
ENGAGEMENT.
REALLY, WE THINK THIS WILL BE
CRITICAL TO ALL THE COMPONENTS
OF RECOVER TLC, AND REALLY WE
WANT TO MAKE SURE THAT WE HAVE
AN ONGOING BILATERAL DIALOGUE
THROUGHOUT ALL OF OUR
ACTIVITIES.
WE HAVE ALREADY FROM THE
BEGINNING ENGAGED COMMUNITY
GROUPS THAT HAD PREVIOUSLY BEEN
INTERACTING WITH RECOVER, AS
WELL AS SOME OF OUR OTHER NIAID
CLINICAL TRIALS ACTIVITIES.
WE ARE ESTABLISHING A NEW
COMMUNITY ENGAGEMENT GROUP FOR
THE PURPOSE OF RECOVER TLC
SPECIFICALLY THAT WILL PROVIDE
FEEDBACK DIRECTLY TO THE
EXECUTIVE COMMITTEE, AND WE'LL
HAVE REPRESENTATIVES ENGAGED IN
EVERY LEVEL OF THE ORGANIZATION
FROM THE PRIORITIZATION GROUPS
TO THE SCIENTIFIC OVERSIGHT
COMMITTEE AND ALL OF THE WORKING
GROUPS.
IN TERMS OF THE CLINICAL TRIALS,
WE REALLY AGAIN ARE HAVING AN
EYE TOWARDS LEVERAGING OUR
EXISTING RESOURCES, SO WE WILL
BE LOOKING ACROSS NOT ONLY NIAID
AND RECOVER BUT OTHER INSTITUTES
TO SEE IF THERE ARE ANY OTHER
CLINICAL TRIAL NETWORKS THAT WE
CAN BRING TO BEAR FOR THIS
EFFORT, AND AGAIN THIS IS
SOMETHING THAT WE DID WITHIN
ACTIVE THAT WORKED VERY WELL.
WE REALLY WANT TO MAKE SURE THAT
WE HAVE CLINICAL TRIAL SITE IN
THE AREAS WHERE WE NEED THEM,
MEANING WHERE THE PEOPLE ARE
LIVING WITH LONG COVID, SO THAT
MIGHT MEAN EVEN BRINGING IN
NOVEL SITES WE HAVEN'T ENGAGED
WITH JUST TO MAKE SURE WE REALLY
ARE INCLUSIVE AND ACCESSIBLE.
IN TERMS OF PROTOCOLS, WE WANT
TO UTILIZE PLATFORM TRIAL
DESIGNS WHERE POSSIBLE TO ALLOW
US TO BE NIMBLE AND BE ABLE TO
ACCOMMODATE ADDITIONAL
INTERVENTIONS QUICKLY.
THE DESIGNS, WE REALLY -- OUR
ULTIMATE AIM IS TO HAVE TRIALS
THAT ARE LARGE ENOUGH TO BE ABLE
TO DEFINITIVELY ASSESS CANDIDATE
THERAPEUTICS FOR SAFETY AND
EFFICACY, BUT RECOGNIZE THAT NOT
ALL INTERVENTIONS WILL
NECESSARILY HAVE THE NECESSARY
DATA THAT WOULD WARRANT A LARGER
TRIAL SO WE'RE ALSO MAINTAINING
FLEXIBILITY AND MIGHT NEED TO DO
SOME SMALLER EXPLORATORY TRIALS
AS WARRANTED.
AND THEN FINALLY, WE WILL HAVE
AN EYE TOWARD CREATING OR USING
A BIO REPOSITORY FOR SPECIMENS,
AS WELL AS A REPOSITORY FOR
CLINICAL DATA.
AGAIN, SO THAT WE CAN MAKE THESE
AVAILABLE TO RESEARCHERS BOTH
WITHIN THE RECOVER TLC
INITIATIVE AS WELL AS OUTSIDE.
THIS IS JUST A SCHEMATIC WITH
THE EXECUTIVE COMMITTEE
OVERSEEING EVERYTHING, AND THE
COMMUNITY ENGAGEMENT GROUP WHICH
IS DEPICTED ALONG THE LEFT SIDE
OF THE SLIDE REALLY PLAYING A
ROLE ACROSS THE ENTIRE
INITIATIVE.
SO WE WERE ABLE TO HAVE OUR
KICKOFF MEETING AS I MENTIONED
AT THE END OF SEPTEMBER AND IT
REALLY WAS AN AMAZING EXPERIENCE
WITH VERY ROBUST INTERACTIONS
AND PARTICIPATION FROM VARIOUS
STAKEHOLDERS BOTH IN PERSON,
THERE WERE ABOUT 180 PEOPLE IN
PERSON AND MORE THAN 1200
PARTICIPANTS ONLINE, WITH REALLY
JUST FANTASTIC DISCUSSION ACROSS
2 1/2 DAYS.
WE WERE FORTUNATE TO HAVE
DR. BERTAGNOLLI AS WELL AS
DR. GERBERDING PRESENT TO
PROVIDE WELCOMING REMARKS OF DR
BADEN.
THE GOALS OF THE WORKSHOP REALLY
WERE TO GET FEEDBACK.
WE REALLY WANTED TO ENGAGE WITH
ALL THE STAKEHOLDERS FOR WHOM
RESEARCH ON LONG COVID IS A
PRIORITY.
SO WE DESIGNED IT AS A HIGH
LEVEL SCIENTIFIC REVIEW WHERE WE
REVIEWED CLINICAL AND
MECHANISTIC DATA WITH AN
EMPHASIS ON GETTING INPUT AND
SPECIFICALLY LOOKING FOR
IMPLICATIONS FOR CLINICAL TRIAL
DESIGN.
THERE WAS OPPORTUNITY TO
HIGHLIGHT WHICH OF THESE DATA
MIGHT BE ABLE TO BE APPLIED TO
CLINICAL TRIALS NOW, WHAT'S
KNOWN ABOUT MECHANISMS, SYMPTOM
BURDEN, AND WHAT INTERVENTIONS
MIGHT BE AVAILABLE.
AT THE END OF THE MEETING,
DR. MORAZZO SUMMARIZED THE KEY
FINDINGS AND ALSO DESCRIBED HOW
WE WOULD BE MOVING FORWARD AS A
RESULT OF RECEIVING ALL OF THIS
INPUT.
IN TERMS OF THE SCIENTIFIC FOCI,
WE TALKED ABOUT PATHOLOGY,
BIOMARKERS, EPIDEMIOLOGY AND THE
COHORT STUDY ONGOING, POTENTIAL
CLINICAL TRIAL DESIGNS, WHAT
STRATEGIES WE'D USE FOR
PRIORITIZING INTERVENTIONS AS
WELL AS SELECTING END POINTS.
AGAIN MANY PARTICIPANTS FROM
ACROSS ALL THE STAKEHOLDER
GROUPS WERE INVOLVED.
INVESTIGATORS FROM BOTH THE U.S.
AS WELL AS INTERNATIONAL
COMMUNITY AND PATIENT GROUPS,
INDUSTRY REPRESENTATIVES, A
NUMBER OF SCIENTISTS AND
CLINICIANS FROM ACROSS THE NIH,
AND A NUMBER OF U.S. GOVERNMENT
AGENCIES REPRESENTED INCLUDING
FDA, CDC, AND SO ON AS LISTED ON
THE SLIDE.
SO SOME OF THE WORKSHOP OUTCOMES
AS I MENTIONED WERE SUMMARIZED
AT THE END OF THE MEETING BY DR.
I WILLIT WAS A VERY EXTENSIVE
DISCUSSION AND IT WAS REALLY
REMARKABLE, THE AMOUNT OF INPUT
WE WERE ABLE TO GET FROM THESE
DISCUSSIONS.
IN TERMS OF COMMUNICATION AND
STRUCTURE, FIRST WE HEARD
THERE'S REALLY TREMENDOUS VALUE
IN JUST ASSEMBLING THIS DIVERSE
GROUP OF PEOPLE WHO ARE ALL
PASSIONATE ABOUT IMPROVING LIFE
FOR PEOPLE LIVING WITH LONG
COVID AS WELL AS OTHER
INFECTION-ASSOCIATED CHRONIC
CONDITIONS.
PATIENT AND COMMUNITY
INVOLVEMENT, AGAIN AS WE SAID
FROM THE OUTSIDE IS REALLY
CRITICAL IN ALL ASPECTS OF
PLANNING THESE TRIALS.
WE HEARD THAT THERE WAS A REAL
DESIRE FOR LEADERSHIP TO BE
ACCOUNTABLE AND VISIBLE AND BE
TRANSPARENT ABOUT THE
DECISION-MAKING PROCESS AND HOW
WE WERE GOING TO BE IMPLEMENTING
CLINICAL TRIALS.
AND ALSO THAT RECOVER HAS
ALREADY MADE ADVANCES IN THE
SCIENCE AND REALLY SHOULD BE
LEVERAGED FOR FUTURE SUCCESS.
SO ALL OF THIS REALLY SORT OF
UNDERSCORING THE GUIDING
PRINCIPLES THAT WE HAD IN PLACE
FOR RECOVER TLC, SO VERY
GRATIFYING TO HEAR THAT
FEEDBACK.
SO WHAT WE HAVE COMMITTED TO DO
IS TO PROVIDE FORUMS FOR REGULAR
ONGOING DIALOGUE WITH THESE --
WITH ALL OF THE STAKEHOLDERS TO
ENSURE THAT THERE'S MEANINGFUL
PARTICIPATION OF PATIENTS AND
ADVOCATES AT EVERY STEP ALONG
THE WAY, AND TO PROVIDE REGULAR
UPDATES ON OUR PROGRESS.
AND I'LL GO INTO A LITTLE BIT
MORE DETAIL ON THAT, HOW WE PLAN
TO DO THAT IN UPCOMING SLIDES.
IN TERMS OF THE CLINICAL TRIALS,
I WOULD SAY THE THEMES WERE
INCLUSIVITY AND ACCESSIBILITY.
WE HEARD A REAL DESIRE FOR THERE
TO BE VERY CONSIDERED -- VERY
CAREFUL CONSIDERATION OF WHAT
THE ENTRY CRITERIA SHOULD BE FOR
CLINICAL TRIALS WITH AN EYE
TOWARD MINIMIZING EXCLUSIONS.
THERE WAS A LOT OF CONCERN THAT
DIFFERENT SUBPOPULATIONS OF
PEOPLE LIVING WITH LONG COVID
MIGHT BE EXCLUDED FROM TRIALS,
EVEN INADVERTENTLY IF WE WERE
NOT VERY CAREFUL ABOUT HOW WE
CRAFT THE ENTRY CRITERIA FOR
CLINICAL TRIALS.
AND THEN WE HEARD OVER AND OVER
AGAIN THAT HE WITH REALLY NEED
TO BE MINDFUL OF ACCESSIBILITY
IN TERMS OF HOW WE DESIGN TRIALS
SO THAT PEOPLE WHO MIGHT HAVE
PARTICULARLY SEVERE SYMPTOMS WHO
ARE EVEN HOMEBOUND OR BED BOUND
STILL MIGHT HAVE ACCESS TO
CLINICAL TRIALS THROUGH NOVEL
WAYS OF BRINGING CLINICAL TRIALS
TO PARTICIPANTS AS OPPOSED TO
PARTICIPANTS HAVING TO GO TO
CLINICAL TRIAL SITES.
SO WE HAVE COMMITTED TO WORKING
CAREFULLY WHEN WE DESIGN OUR
TRIALS AND WHEN WE REVIEW SITES
TO REALLY KEEP IN MIND THESE
THEMES OF INCLUSIVITY AND
ACCESSIBILITY.
AGAIN VERY IMPORTANT TO LINK
WHATEVER INTERVENTIONS WE WIND
UP EVALUATING BACK TO THE
PATHOBIOLOGY.
IT NEEDS TO MAKE SCIENTIFIC
SENSE AND WE HAVE A LOT OF WORK
THAT WE CAN LEVERAGE, IN
PARTICULAR THE BIOREPOSITORY
THAT'S BEEN PUT TOGETHER BY
RECOVER WAS MENTIONED, THAT WE
REALLY NEED TO TAKE ADVANTAGE OF
RESOURCES THAT ARE ALREADY IN
PLACE, AND SO WE HAVE PLEDGED TO
INVESTIGATE HOW WE CAN USE THOSE
SPECIMENS AND DATA THROUGH OUR
WORKING GROUPS AND THROUGH
INVESTIGATIONS AT AN INDIVIDUAL
INVESTIGATOR LEVEL, IN ORDER TO
INFORM OUR CLINICAL TRIAL
PRIORITIZATION.
AND AGAIN INVOLVEMENT OF PEOPLE
LIVING WITH LONG COVID EVERY
STEP OF THE WAY, THESE ARE SORT
OF BASIC TENETS OF GOOD
PARTICIPATORY PRACTICE, WHICH IS
SOMETHING THAT NIAID HAS
ESPOUSED FOR A VERY LONG TIME,
MEANING THAT WE WILL INCLUDE
PEOPLE LIVING WITH LONG COVID IN
EVERY ASPECT OF PLANNING
CLINICAL TRIALS FROM THE
INTERVENTION SELECTION TO TRIAL
DESIGN, TRIAL CONDUCT,
INTERPRETATION, DISSEMINATION,
AND IMPLEMENTATION OF THE
FINDINGS.
SO SINCE THE WORKSHOP, WHAT HAVE
WE BEEN DOING?
WE HAVE A WORKSHOP REPORT THAT
IS COMING OUT IMMINENTLY, MAYBE
EVEN AS SOON AS TOMORROW, BUT
CERTAINLY BY NEXT WEEK, AND THEN
THAT WILL BE FOLLOWED BY A
MANUSCRIPT THAT ESSENTIALLY WILL
BE AN EXECUTIVE SUMMARY OF THE
LONGER WORKSHOP REPORT COMING
SHORTLY THEREAFTER.
WE HAVE LAUNCHED A PORTAL FOR
SUBMISSION OF THERAPEUTICS THAT
WAS LAUNCHED -- I THINK IT WAS
THE DAY AFTER THE MEETING
CONCLUDED, AND THUS FAR, WE HAVE
HAD OVER 400 SUBMISSIONS FROM
VARIOUS STAKEHOLDERS, PEOPLE
LIVING WITH LONG COVID, FROM
CARE PROVIDERS, FROM ACADEMICI,
FROM FOLKS WITHIN NIH.
WE HAD ALREADY STARTED TO PUT
TOGETHER A CLINICAL TRIALS
LANDSCAPE AND WE HAVE THAT
ONGOING MONITORING OF WHAT ELSE
IS GOING ON BASICALLY IN THE
FIELD IN ORDER TO, AGAIN, NOT
DUPLICATE EFFORTS, AND WE HAVE
ALSO ESTABLISHED OUR
PRIORITIZATION PROCESS, MEANING
WE'VE PUT TOGETHER THE CRITERIA
AND SCORING RUBRIC THAT WE'LL BE
USING ACROSS PRIORITIZATION
GROUPS WHEN WE TAKE A LOOK AT
THESE CANDIDATE THAT HAVE COME
IN.
WE ALSO PUBLISHED A REQUEST FOR
INFORMATION OR RFI BACK IN
OCTOBER THAT WILL BE OPEN
THROUGH FEBRUARY.
THIS IS AN ADDITIONAL MEANS OF
FOLKS SUBMITTING POTENTIAL
THERAPEUTICS THAT THEY'D LIKE
THE RECOVER TLC GROUP TO LOOK
AT.
THIS HAS ALSO BEEN A WAY FOR
PEOPLE TO VOLUNTEER TO
PARTICIPATE IN THE WORKING
GROUPS, AND THIS IS A PRIMARY
WAY THAT WE'VE BEEN DRAWING
MEMBERS FOR OUR INDIVIDUAL
PRIORITIZATION GROUPS AND
WORKING GROUPS FROM RESPONSES TO
THIS RFI.
WE ALSO ARE SOLICITING
SUGGESTIONS FOR BIOMARKER WORK
AS WELL AS JUST GENERAL FEEDBACK
FOR ANYONE THAT WASN'T ABLE TO
BE HEARD AT OUR WORKSHOP.
WHAT HAVE WE SEEN COMING THROUGH
THE PORTAL SO FAR?
THIS IS NOT QUITE UP TO DATE,
THIS IS A DATA POLL WE DID BACK
IN NOVEMBER, BUT YOU GET A SENSE
WE HAD AT THAT TIME 313 TOTAL
SUBMISSIONS FROM 232 DISTINCT
RESPONDENTS, THAT NUMBER HAS
AGAIN GONE UP, CLOSER TO 400, I
THINK WE'RE A LITTLE OVER 400
NOW.
AND WHAT WERE THESE
INTERVENTIONS THAT WERE
SUBMITTED?
PRIMARILY 70% OF THEM WERE
DRUGS, AND OF THOSE DRUGS, THE
MAJORITY OF THOSE, 345%, WERE
IMMUNOMODULATORY AGENTS.
THERE WERE ALSO A SIGNIFICANT
NUMBER OF NEUROLOGICAL AGENTS,
24%, AND THEN SOME ANTIVIRALS,
HOST DIRECTED AND OTHERS.
THIS REALLY REFLECTS, I THINK,
SOMETHING WE ALSO HEARD AT THE
WORKSHOP, WHICH WAS THE DESIRE
REALLY TO BE LOOKING AT
PHARMACOLOGIC INTERVENTIONS AS
OPPOSED TO THIRNLI THINGS LIKE E
OR OTHER LIFESTYLE MODIFICAT
MODIFICATIONS.
THEN HOW WILL WE BE APPROACHING
THE REVIEW?
WE'RE WELL ON OUR WAY TO HAVING
DONE SOME SORT OF CATEGORIZATION
AND BUCKETING OF THE AGENTS THAT
HAVE COME THROUGH.
AGAIN WE'VE COLLECTED THE NAMES
OF ALL VOLUNTEERS THROUGH RFI
AND SENT OUT INVITATIONS TO
POPULATE OUR PRIORITIZATION
GROUPS THAT WE'RE STILL IN THE
PROCESS, WE HAVE A NUMBER OF
GROUPS WE NEED TO PUT TOGETHER,
AND WE WERE STARTING WITH THE
APT VIRALS.
WE'VE ISSUED CDAs TO BE SIGNED
AND SO ON, SO WE'RE ACTUALLY
READY TO GO FOR OUR FIRST
REVIEW, OUR FIRST ROUND OF
ANTIVIRALS ON MONDAY.
SO WE'RE EXCITED TO GET STARTED
WITH THAT.
AND THEN IN TERMS OF ONGOING
COMMUNICATION, WE'RE REALLY
COMMITTED, AGAIN, TO BEING
TRANSPARENT AND KEEPING UP THE
DIALOGUE.
WE'RE COMMITTED TO HAVING AN
ANNUAL MEETING WHERE WE WILL
DISSEMINATE THE LATEST RESEARCH
AND CLINICAL FINDINGS THAT WE
HAVE AND REVIEW OUR OVERALL
PROGRESS, BUT ANNUAL MEETINGS
REALLY, I THINK, ARE
INSUFFICIENT FOR MAKING SURE
THAT EVERYBODY FEELS THAT THEY
ARE AWARE OF WHAT'S GOING ON
WITHIN THE RECOVER TLC
INITIATIVE AND HAVE AN
OPPORTUNITY TO PROVIDE INPUT.
SO WE ARE COMMITTED TO DOING
REGULAR WEBINARS.
WE HAD ONE AT THE END OF
NOVEMBER THAT WAS ATTENDED BY
OVER 800 PARTICIPANTS ONLINE.
WE HAVE HAD A NUMBER OF BLOG
POSTS AND WE'LL CONTINUE TO DO
BOTH BLOG POSTS AND WEBINARS ON
A REGULAR CADENCE.
WE HAVE OUR NEXT WEBINAR PLANNED
FOR EARLY JANUARY, AND WE ALSO
HAVE A PLAN FOR NEWSLETTERS TO
BE SHARED AND WE HAVE ONE TEED
UP THAT SHOULD BE COMING OUT
SOON.
AGAIN IN ORDER TO SHARE MORE UP
TO THE MINUTE PROGRESS WITHIN
THE INITIATIVE.
I THINK THAT MIGHT BE MY LAST
SLIDE, BUT -- THAT'S ALL.
SO I THANK YOU VERY MUCH AGAIN
FOR THE OPPORTUNITY TO DESCRIBE
THE WORK THAT WE'VE BEEN DOING
SO FAR, AND I'LL LEAVE TO MONICA
AS TO WHEN TO TAKE QUESTIONS OR
RECEIVE COMMENT.
>> OKAY.
WELL, WE'LL DO THAT AT THE END.
THANK YOU SO MUCH, SARAH, AND
WE'RE JUST GRATEFUL FOR YOUR
TEAM AND ALSO THE HELP OF
DR. TARA SCHWETZ AND THE PEOPLE
IN THE DIRECTOR'S OFFICE WHO'VE
ALSO HELPED FACILITATE THIS
REALLY IMPORTANT NEW PHASE OF
OUR WORK AND TO BATTLE LONG
COVID.
SO JUST A FEW COMMENTS NOW FROM
ME KIND OF OVERALL ABOUT LONG
COVID.
FIRST OF ALL, I'M SURE YOU ALL
KNOW, POST VIRAL SYNDROMES HAVE
ALWAYS BEEN WITH US, AND THEY'VE
ALWAYS BEEN DIFFICULT.
WE HAVE NOT BEEN ABLE TO
UNDERSTAND THEM, DIAGNOSE THEM,
TREAT THEM.
AND LONG COVID NOW TEACHES US
MANY NEW THINGS ABOUT THESE VERY
PREVALENT CONDITIONS.
MAYBE ONE OF THE MOST IMPORTANT
IS THAT THERE ARE -- THE COHORTS
THAT I'LL DESCRIBE IN A MINUTE
ARE HELPING US UNCOVER THE KIND
OF LINGERING SUBCLINICAL EFFECTS
THAT HAPPEN AFTER PEOPLE ARE
INFECTED BY VARIOUS AGENTS.
MANY PEOPLE ARE OUT THERE IN OUR
WORLD THAT HAVE ISSUES RELATED
TO A PRIOR INFECTION THAT ARE
NEVER DIAGNOSED, AND WHEN YOU
REALLY START TO WRAP YOUR HEAD
AROUND THE SUFFERING THAT THIS
CREATES NATIONWIDE, IT MAKES
SENSE THAT WE DON'T DEVOTE A
TREMENDOUS EFFORT TO USING THIS
NEW ONSET -- NEW TYPE OF DISEASE
AND THE OPPORTUNITY FOR
UNDERSTANDING ITS EFFECTS IN
BASIC BIOLOGY, UNPRECEDENTED
SCOPE AND SCALE TO RESEARCH TO
TRULY TACKLE THIS PROBLEM FOR
THE FIRST TIME.
OUR WORK IN LONG COVID IS REALLY
SETTING A NEW PARADIGM FOR HOW
WE THINK ABOUT RESPONSE TO A
CLINICAL NEED.
I THINK YOU CAN ALREADY SEE THAT
IN THE OVERALL APPROACH, SEEINGN
WITH RECOVER TLC.
OKAY.
PEOPLE WITH LONG COVID KNOW HOW
COMPLICATED THIS RESEARCH IS.
AND THEIR CARE PROVIDERS KNOW.
I DON'T THINK THE REST OF THE
WORLD REALLY REALIZED THIS.
IT'S A HIGHLY VARIABLE CONDITION
THAT CAN WAX AND WANE.
IT DIFFERS BY AGE, GENDER,
VACCINATION STATUS, SO MANY
OTHER EFFECTS IN LIFE.
AND WHEN IT LANDED IN OUR WORLD
IN EARLY 2020, WE DIDN'T HAVE A
CLEAR DEFINITION OF WHAT IT WAS
THAT COULD EVEN PROVIDE BOTH
CLINICIANS AND CERTAINLY THERAPY
DEVELOPMENTS END POINT TO
UNDERSTAND HOW TO DEVELOP
TREATMENTS.
WE NEEDED RESOURCES, NOT ONLY TO
JUST DIAGNOSE THE DISEASE BUT
ALSO UNDERSTAND BIOLOGY IN WAYS
THAT COULD LEAD TO EFFECTIVE
THERAPY.
SO WITH THAT INTRO, I WANT TO
FIRST NOTE THAT -- GIVE A
FUNDING UP TA UPDATE FOR LONG C.
IN 2021, CONGRESS APPROPRIATED
$1.15 BILLION TO SUPPORT THE
ESTABLISHMENT OF RECOVER,
RESEARCH IN COVID TO ENHANCE
RECOVERY, A NATIONWIDE RESEARCH
PROGRAM.
I ALSO WANT TO NOTE THAT NIH
RECENTLY RECEIVED AN ADDITIONAL
$147 MILLION TO SUPPORT OUR
ONGOING RECOVER EFFORTS.
THIS ALLOCATION IS YET IN
ADDITION TO THE $515 MILLION
SUPPORT FOR ONGOING RECOVER
EFFORTS.
SO THE $662 MILLION WILL BE
ALLOCATED OVER FISCAL YEARS 2025
TO 2029 TO SUPPORT OUR ONGOING
RECOVERY EFFORTS.
THIS ALLOCATION IS YET IN
ADDITION TO THE $515 MILLION TO
SUPPORT OUR ONGOING RECOVERY
EFFORTS.
FOR OUR ONGOING RECOVER EFFORTS
THIS ALLOCATION IS YET IN
ADDITION TO THE 515 MILL YONDZ
SUPPORT FOR ONGOING RECOVER
EFFORTS, SO THE $662 MILLION --
ADDITIONAL PATHOBIOLOGY STUDIES
TO IDENTIFY THE BIOLOGICAL
MARKERS OF DISEASE.
RIGHT NOW IT'S A CLINICAL
DEFINITION OF HIGHLY VARIABLE
PHENOTYPE.
WE REALLY DO NEED A BIOLOGICAL
END POINT THAT WE CANNOT ONLY
TARGET FOR THERAPY DEVELOPMENT
BUT ALSO USE FOR EFFECTIVE
DIAGNOSIS.
THIS IS GOING TO BE PARTICULARLY
IMPORTANT AS THE COHORT OF
PEOPLE THAT HAVE NEVER HAD
COVID, WHICH ARE PROVIDING THE
VERY IMPORTANT COMPARATORS TO
UNDERSTAND THE DIFFERENCE
BETWEEN COVID -- BETWEEN NOT
LONG COVID AND LONG COVID AS
THIS POPULATION GETS SMALLER AND
SMALLER AS COVID TRULY BECOMES
ENDEMIC IN OUR POPULATION.
SO REALLY CRITICAL THAT WE FIND
BIOMARKERS.
THEN FINALLY, WE ALSO NEED TO
PRESERVE AND PROVIDE BROADER
ACCESS TO THE DATA AND
BIOSPECIMENS, AND MAINTAIN THE
RECOVERY SEARCH INFRASTRUCTURE
OVER THE NEXT FIVE YEARS.
THIS SLIDE SHOWS THE THREE MAIN
RECOVERY SEARCH COMPONENTS,
OBSERVATIONAL COHORTS,
PATHOBIOLOGY STUDIES, AND
CLINICAL TRIALS.
RECOVER INCLUDES A CLINICAL
TRIAL COORDINATING CENTER, A
CLINICAL SCIENCE CORE, A DATA
RESOURCE CORE AND A
BIOREPOSITORY.
HERE'S A SNAPSHOT OF RECOVER
EFFORTS SO FAR.
YOU AND THE COMMITTEE WILL HAVE
THESE SLIDES AVAILABLE TO YOU.
I'M NOT GOING TO GO OVER EVERY
ONE OF THEM, BUT YOU CAN SEE,
RECOVER IS THE MOST DIVERSE,
DEEPLY CARE TERKIZED COHORT OF
LONG COVID PATIENTS.
IT IS THE -- ALSO THE LARGEST
AND MOST DIVERSE COHORT OF ANY
POST -- THAT HAS A NEGATIVE EXAI
TORE GROUP FOR STUDY OF -- IN
REALTIME OF A POST VIRAL
SYNDROME.
HIGHLIGHTING, AGAIN, THAT WE
BELIEVE THIS WORK WILL HAVE
IMPLICATIONS BEYOND JUST THE
COVID ORGANISM ITSELF.
THOUSANDS OF RESEARCH
PARTICIPANTS HAVE JOINED US AS
PARTNERS IN THIS EFFORT.
AS THIS WORK MATURES, WE ARE
LEARNING A TREMENDOUS AMOUNT
CONCERNING THE NATURE AND
UNDERLYING CAUSES OF THIS VERY
COMPLEX NEW CONDITION.
THE FULL RECOVER COHORT INCLUDES
ALMOST 30,000 PARTICIPANTS
ACROSS THREE MAJOR GROUPS:
ABOUT HALF ARE ADULTS, ABOUT
HALF ARE CHILDREN, AND A
RELATIVELY SMALL NUMBER OF
TISSUE PATHOLOGY OR AUTOPSY
CASES.
PARTICIPANTS WERE ENROLLED WHEN
THEY HAD ACUTE COVID INFECTIONS,
WERE UNINFECTED AND
SEROCONFIRMED TO BE UNINFECTED,
OR IN THE POST-ACUTE PHASE.
DECEASED PARTICIPANTS WHO ARE AT
LEAST 18 YEARS OLD AND WERE
SUSPECTED OR CONFIRMED TO HAVE
HAD COVID WITHIN 60 DAYS OF
THEIR DEATH, WE HONOR THEIR
CONTRIBUTION TO SCIENCE WITH
ALLOWING US TO PURSUE THESE VERY
DETAILED AUTOPSIES.
VERY GRATEFUL TO THESE
INDIVIDUALS AND THEIR FAMILIES.
THEY WERE CONSIDERED IN THE MOST
ACUTE -- POST-ACUTE CATEGORY IF
THEY'D BEEN 30 DAYS OR MORE FROM
THEIR COVID ONSET -- SYMPTOM
ONSET.
THE ADULT COHORT IS FULLY
ENROLLED, THE PEDIATRIC COHORT
IS ALMOST COMPLETELY ENROLLED,
AND THE AUTOPSY COHORT IS ABOUT
60% ENROLLED.
THIS SLIDE OUTLINES SECURE DATA
NOW AVAILABLE TO AUTHORIZED
RESEARCHERS THROUGH THE
CLOUD-BASED ECOSYSTEM BIODATA
CATALYST.
IN ALL, DATA ARE AVAILABLE FOR
MORE THAN 15,000 ADULTS
INCLUDING A SUBCOHORT OF MORE
THAN 2,000 PREGNANT WOMEN AND
MORE THAN 24,000 YOUNG ADULTS,
CHILDREN, INFANTS AND
CAREGIVERS.
SOME INFANTS, SOME EXPOSED TO
COVID WHEN THEIR MOTHERS WERE
INFECTED WHEN THEY WERE
PREGNANT.
AND ALSO DATA FROM THEIR
CAREGIVERS.
DATA COLLECTED FROM MORE THAN
184,000 VISITS, WHY DO WE NEED
ALL THIS DATA?
THIS DATA IS AVAILABLE TO SPUR
AN INCREDIBLE, UNPRECEDENTED, WE
WILL NEVER HAVE IT AGAIN
RESOURCE FOR INNOVATION,
COLLABORATION, AND DISCOVERY.
AND TO PROVIDE A PLATFORM FOR
DATA SHARING AND, VERY
IMPORTANT, VALIDATING RESULTS AS
WE MOVE FORWARD.
THIS DATA CAN HELP PEOPLE MAKE
CONNECTIONS THAT WILL INFORM ALL
FUTURE STUDIES, PARTICULARLY
CLINICAL TRIALS.
HAVING SAMPLES AVAILABLE SHOULD
ENABLE FURTHER HYPOTHESIS
TESTING THROUGH PATHOBIOLOGY
STUDIES, AND THIS IS JUST THE
BEGINNING.
ADDITIONAL ADULT PEDIATRIC AND
AUTOPSY COHORT DATA FROM RECOVER
WILL CONTINUE TO BE RELEASED ON
AN ONGOING BASIS.
MORE THAN -- ABOUT PUBLICATIONS,
MORE THAN 50 PAPERS HAVE BEEN
PUBLISHED ON KEY CLINICAL
FINDINGS JUST BASED ON THE
OBSERVATIONAL COHORTS ALONE.
WE'VE DEVELOPED A SYMPTOM-BASED
OF LONG COVID IN ADULTS AND
CHILDREN.
I CANNOT EMPHASIZE STRONGLY
ENOUGH HOW CHALLENGING THIS WAS.
IT REALLY BASICALLY IS WHAT KIND
OF SYMPTOMS DO PEOPLE HAVE WHO
HAVE NEVER HAD COVID AND WHAT
KIND OF SYMPTOMS DO PEOPLE HAVE
WHO HAVE EXPERIENCED COVID OF
ALL THE VARIOUS SUBTYPES AND ALL
THE VARIOUS STAGES AFTER
EXPOSURE TO THE VIRUS.
AND REALLY, IT'S THE DIFFERENCE
IN CLINICAL CHARACTERISTICS.
DO I HAVE BRAIN FOG, DOES EVERY
MUSCLE IN MY BODY ACHE, DO I
HAVE CHRONIC FATIGUE.
DIFFERENCE IN SYMPTOMS BETWEEN
THOSE TWO POPULATIONS THAT HAS
LED TO THIS DIAGNOSIS.
WE'VE DEVELOPED THIS -- AND BY
THE WAY, IT'S DIFFERENT IN GRADE
SCHOOL KIDS, ADOLESCENTS AND
ADULTS, AND THIS SYMPTOM COMPLEX
IS DIFFERENT IN PEOPLE WHO,
BASED ON AGE, THEIR GENDER AND
WHETHER THEY'VE HAD A
VACCINATION, AND EVEN TO
SOME DEGREE WHAT VIRAL SUBGROUP
THEY'VE BEEN EXPOSED TO.
SO I HOPE I'VE ILLUSTRATED IN A
SNAPSHOT HERE JUST HOW
INCREDIBLY COMPLEX THIS IS.
WE'VE DEFINED THE SYMPTOMS AND
CONDITIONS THROUGH THESE COHORTS
THAT ARE SPECIFIC TO LONG COVID.
I'LL CALL YOUR ATTENTION TO THAT
IN CHILDREN, WHICH HAVE
PARTICULARLY PRONE TO
CIRCULATORY AND RE RE RE R -- WN
THAT VACCINATION SIGNIFICANTLY
DECREASES THE RESULT OF
DEVELOPING LONG COVID.
THIS IS ANOTHER THING I CANNOT
EMPHASIZE ENOUGH.
VACCINATION IS THE BEST THING WE
HAVE RIGHT NOW.
LONG COVID IS SERIOUS IN SOME
PEOPLE, IT IS ABSOLUTELY
LIFE-ALTERING, AND THE WAY TO
PREVENT IT IS TO RECEIVE A
VACCINATION AND THE VERY BEST
WAY TO PREVENT IT IS IF WHEN
THAT VACCINATION IS ADMINISTERED
BEFORE A PERSON EVER HAS THEIR
FIRST EXPOSURE TO THE VIRUS.
WE HAVE OBSERVED A HIGHER RISK
OF NEW CARDIOVASCULAR,
NEUROLOGIC AND ENDOCRINE AND GI
SYMPTOMS IN BLACK AND HISPANIC
PATIENTS, A DISPARITY WE DON'T
FULLY UNDERSTAND.
WE'VE IDENTIFIED SOME
DISTINGUISHING IMMUNE FEATURES
OF LONG COVID.
IF THIS DISEASE IS STICKING
AROUND, MAYBE THE IMMUNE
SYSTEM -- IT LOOKS LIKE THE
IMMUNE SYSTEM IS JUST NOT
EFFECTIVELY FIGHTING IT OFF.
ALL THIS WORK IS LEADING TO
IMPROVED DIAGNOSTICS, MONITORING
AND CARE FOR PATIENTS, BETTER
PREVENTIVE CARE, AND GETTING US
TOWARD MORE EFFECTIVE TARGETED
TREATMENTS.
JUST A LITTLE REVIEW QUICKLY
HERE, SOME KEY DISCOVERIES FROM
THE OBSERVATIONAL COHORTS.
PATIENT IN JAMA LAST YEAR, THE
FIRST STRUCTURED FRAMEWORK FOR
HOW WE DIAGNOSE LONG COVID IN
ADULTS, BASED ON SYMPTOMS.
AND DESCRIBES THE RISK
ASSOCIATED WITH THE DIFFERENT
STRAINS.
THIS FRAMEWORK HAS BEEN USED BY
MANY OTHER GROUPS.
THIS MANUSCRIPT ACTUALLY WAS THE
THIRD MOST REVIEWED AND THE
SECOND MOST DISCUSSED AND HAD
THE VERY HIGHEST SCORE OF ALL
PAPERS IN 2023 SO IT REALLY WAS
A GROUNDBREAKING RESULT.
ANOTHER MORE RECENT PAPER IN
JAMA PROVIDED THE FIRST
FRAMEWORK FOR IDENTIFYING LONG
COVID IN BOTH CHILDREN AND
ADOLESCENTS BASED ON THEIR
DIFFERENT TYPES OF SYMPTOMS.
OTHER KEY PAPERS, THE PREVALENCE
AND RISK FACTORS FOR PREGNANT
PEOPLE DEVELOPING LONG COVID
FOCUSED ON SOME PATHOBIOLOGY AND
BIOMARKER RESEARCH BY SHOWING
UNFORTUNATELY THAT 25 COMMON
BLOOD LAB TESTS ARE NOT RELIABLE
BIOMARKERS FOR LONG COVID.
IDENTIFYING CIRCULATING
SARS-COV-2 ANTIGENS IN THE BLOOD
OF PEOPLE WITH LONG COVID AFTER
THEY HAD AN ACUTE INFECTION THAT
CONTRIBUTE TO THE GROWING
EVIDENCE THAT VIRAL PERSISTENCE
MAY BE A CONTRIBUTING MECHANISM
TO LONG COVID.
AND THE MOST WELL SUPPORTED
HYPOTHESIS NOW IS, YOU GET A
COVID INFECTION, SOMEHOW YOUR
IMMUNE SYSTEM TRIES TO FIGHT IT
OFF BUT JUST IS INEFFECTIVE, AND
THAT LEADS TO THAT VIRUS
STICKING AROUND.
RECOVER PATHOBIOLOGY STUDIES
LOOK AT BIOLOGICAL MECHANISMS
THAT CAN BE USED TO DEVELOP NEW
OR MORE TARGETED TREATMENTS.
THE RESEARCH IS ADVANCING OUR
UNDERSTANDING OF SO MANY CHANGES
IN BODY TISSUES AND ORGANS
CAUSED BY THE COV2 INFECTION,
IDENTIFYING BIOLOGIC MARKERS FOR
THERAPEUTIC TARGETS BASED ON AN
INDIVIDUAL'S RISK FACTORS.
I'LL EMPHASIZE IT AGAIN, THIS IS
NOT -- THIS IS AN INCREDIBLY
DIVERSE SPECTRUM OF SYMPTOMS.
NOT JUST ONE THING THAT CAN
EASILY BE IDENTIFIED.
BY EXAMINING SPECIMENS SUCH AS
BLOOD, SALIVA AND OTHER SAMPLES
AND DATA COLLECTED FROM THESE
RECOVER COHORTS AND TRIALS,
PATHOBIOLOGY STUDIES ARE HELPING
US STAWND HOW THE VIRUS CAN
PERSIST IN THE BODY, THE EFFECTS
OF THE VIRUS ON CERTAIN ORGANS
LIKE RESPIRATORY, VASCULAR, THE
IMMUNE SYSTEM.
AND EXAMPLES OF RESULTS WE HAVE
TODAY INDICATE THAT, AS I SAID,
THIS MAY CAUSE LONG LASTING
ALTERATIONS TO THE INNATE IMMUNE
SYSTEM, AND CAN ALSO MAKE PEOPLE
WHO HAVE LONG COVID MORE
SUSCEPTIBLE TO A HOST OF OTHER
INFECTIONS.
AND THEN SOME LONG COVID
SUFFERERS APPEAR TO HAVE
PERSISTENT INFECTION AND ONE OF
OUR MAIN HYPOTHESES TODAY IS
THAT THEY MAY RESPOND TO MORE
RIGOROUS TREATMENT WITH
ANTIVIRAL MEDICATION.
RECOVER WILL -- WE WILL AWARD
NEARLY $18 MILLION FROM THE
INITIAL $1.5 BILLION TOWARD AN
ADDITIONAL 20 PATHOLOGY RESEARCH
STUDIES NOW.
THESE SUBAWARDS ARE IN ADDITION
TO MORE THAN 40 PATHOBIOLOGY
RESEARCH PROJECTS AWARDED IN
2022.
SO THAT ORIGINAL FUNDING FROM
CONGRESS IS STILL WORKING VERY
HARD FOR BOTH THE COHORT AND THE
PATHOBIOLOGY.
ALSO AS A RESULT OF THE INITIAL
WAVE OF WORK, THIS IS BEFORE
RECOVER TLC WAS LAUNCHED BASED
ON ALL THE NEW DATA, THERE WERE
CURRENTLY EIGHT CLINICAL TRIALS
UNDERWAY, TESTING 13
INTERVENTIONS.
THESE ARE FOCUSED ON FINDING
INTERVENTIONS NOT ONLY TO TREAT
THE VIRAL PERSISTENCE, WHICH HAS
BEEN A HYPOTHESIS SINCE DAY ONE,
BUT ALSO SPECIFICALLY TO HELP
PEOPLE RIGHT AWAY WITH COGNITIVE
DYSFUNCTION, POSTURAL
ORTHOSTATIC TACHYCARDIA SYNDROME
OR POTS, COMPLEX SLEEP
DISTURBANCES, EXERCISE
INTOLERANCE AND POST EXERTIONAL
MALAISE.
I'LL JUST EMPHASIZE AGAIN, THESE
ARE NOT NEW.
THESE ARE THE KINDS OF THINGS WE
SEE THAT OCCUR IN OTHER POST
VIRAL SYMPTOMS.
SO UPDATE ON THESE EARLIER
LAUNCHED TRIALS.
THE VITAL AND NEURO TRIALS ARE
FULLY ENROLLED.
FOLLOW-UP FOR THE NEURO TRIAL IS
EXPECTED IN -- WILL END THIS
MONTH AND FOLLOW-UP FOR THE
VITAL TRIAL WILL END IN
MARCH 2025.
THE AUTONOMIC, SLEEP AND
ENERGIZE TRIALS ARE STILL OPEN
TO ENROLLMENT AND EXPECTED TO
END ENROLLMENT LATER NEXT YEAR
WITH FOLLOW-UP CONTINUING INTO
2026.
SO WE LOOK FORWARD TO SEEING THE
RESULTS OF THESE.
SO TO CLOSE, I JUST WANT TO
STRESS THAT LONG COVID IS A
COMPLEX DEBILITATING CONDITION
THAT AFFECTS PEOPLE'S ABILITY TO
WORK, ATTEND SCHOOL, PARTICIPATE
IN THEIR REGULAR ACTIVITY, AND
EVEN, I THINK, WE'RE SEEING
EXPERIENCE TELLING US IT ALSO
CONTRIBUTES TO EVEN SUBCLINICAL
DISEASE THAT AFFECTS PEOPLE SAND
PART OF A TYPE OF POST
INFECTIOUS COMPLICATION THAT WE
HAVE REALLY BEEN STYMIED FOR
FOREVER.
SO, THEREFORE, WE, NIH, REMAINS
COMMITTED TO ALLEVIATING THE
SUFFERING OF SO MANY
INDIVIDUALS, THEIR FAMILIES AND
CAREGIVERS, FINDING A WAY
THROUGH APPLICATION OF SCIENCE,
BIOLOGY, DRUG DEVELOPMENT, AND
THERAPY DELIVERY TO REALLY END
SUFFERING FROM ALL OF THESE
DISEASES AND, IN PARTICULAR,
LONG COVID.
WE LOOK FORWARD TO FURTHER
ADVANCING OUR UNDERSTANDING, AND
ALSO ADVANCING PREVENTION AND
TREATMENT OF ALL OF THESE
SPECTRUM OF DISEASES.
THANK YOU SO MUCH.
NOW WE CAN TAKE SOME QUESTIONS
ABOUT RECOVER.
>> GREAT.
SO IF YOU COULD PULL DOWN THE --
GREAT.
ANYBODY WHO HAS A QUESTION?
YES, GISELLE, YOU CAN START.
>> YES, I APOLOGIZE, I CANNOT
GET MY VIDEO TO TURN ON.
I'VE BEEN TRYING SINCE WE CAME
BACK FROM THE BREAK.
>> NOT A PROBLEM.
>> YES, I WISH I COULD START MY
VIDEO.
I GOT A LITTLE NOTE THAT THE
CO-HOST IS ASKING ME TO START IT
BUT FOR WHATEVER REASON, I CAN'T
START IT.
>> WE'LL TAKE EXTRAMURAL OUT.
DON'T WORRY.
>> THANK YOU.
>> FIRST OF WILL ALL FIRST OF A,
DR. MONICA, DR. READ, THANK YOU
FOR THESE PRESENTATIONS.
THIS WORK IS SO VITALLY
IMPORTANT.
MY QUESTION HAS TO DO WITH THE
RELATIONSHIP, IF ANY, THERE IS
WITH RADX UP, PARTICULARLY,
THERE WERE 125 SITE.
THAT STUDY, OR THAT INITIATIVE
IS CLOSING NOW AFTER FIVE YEARS,
AND THERE'S 125 SITES IN
COMMUNITIES THAT HAD MOST
HARD-HIT BY THE PANDEMIC.
THIS IS ALL IN SERVICE OF
ENSURING THAT ESSENTIAL WORKERS,
THOSE THAT WERE MOST -- THOSE
COMMUNITIES THAT WERE MOST
IMPACTED HAVE THE OPPORTUNITY TO
PARTICIPATE.
I WAS EXCITED TO HEAR ABOUT
ACCESSIBILITY CONSIDERATIONS,
BECAUSE SO MANY OF THOSE
INDIVIDUALS, WHEN THEY WERE
EXPOSED AS ESSENTIAL WORKERS OR
HEALTHCARE WORKERS OR
COMMUNITIES THAT WEREN'T ABLE TO
GET TESTING OR TREATMENT, HAVE
LIMITATIONS IN TERMS OF THEIR
ABILITY TO COME TO A
COORDINATING CENTER AND
PARTICIPATE IN A CLINICAL TRIAL,
FOR EXAMPLE.
SO I'M PARTICULARLY INTERESTED
TO THINK ABOUT AND HEAR WHAT
EXPECTATIONS THERE ARE IN USE OF
TECHNOLOGY OR OTHER WAYS TO
INCLUDE INDIVIDUALS SO THAT THEY
CAN PARTICIPATE IN A CLINICAL
TRIAL IF THEY WORK AN HOURLY
WAGE, FOR EXAMPLE, OR WORKING
THE NIGHT SHIFT OR WHAT HAVE
YOU.
THANK YOU.
>> THANK YOU SO MUCH FOR RAISING
THIS IMPORTANT ISSUE.
AND SO I HAVE TO BE REALLY VERY
HONEST AND TRANSPARENT ABOUT
THIS.
WE DON'T HAVE THE BUDGET THAT IS
GOING TO ALLOW US TO INCLUDE
EVERYONE WE WANT TO IN THE
ONGOING CLINICAL TRIALS.
WE JUST DON'T HAVE THAT BUDGET.
I CAN TELL YOU THAT EVERY EFFORT
IS BEING MADE, WITH A MANDATE TO
CONTINUE THE DIVERSITY OF THE
SCOPE OF INDIVIDUALS
PARTICIPATING IN THESE TRIALS.
I MEAN, THAT'S OUR CORE MANDATE
ACROSS ALL OF NIH, AND CERTAINLY
WILL CONTINUE HERE.
SO I CAN'T SPEAK INDIVIDUALLY TO
WHICH TRIAL CENTERS CAN GO
FORWARD BECAUSE WE'VE JUST GOT
AN ISSUE OF ECONOMICS THAT WE
HAVE TO TE DEAL WITH.
NOW, THAT BEING SAID, ONE OF THE
BRIGHT SPOTS WE'VE ALSO GOT HERE
IS ENGAGEMENT TO THE FOUNDATION
FOR THE NIH, WHICH HAS BEEN --
THROUGH RECOVER TLC BEEN BROUGHT
INTO THIS EFFORT.
SO WE'RE LOOKING TO MOVE AND
EXPAND HOPEFULLY ON WHAT WE SEE
WITH PUBLIC FUNDING, AND ALSO
BEING ABLE TO EXPAND WITH
PARTICIPATION OF HOPEFULLY
PHARMACEUTICAL PARTNERS AND ABLE
TO EXPAND TESTING OF IMPORTANT
AGENTS.
SO THANK YOU FOR RAISING THIS
ISSUE.
I CAN'T TELL YOU HOW WE WISH
THAT WE COULD CONTINUE THE
BROADEST POSSIBLE ENGAGEMENT IN
THESE SITES.
THAT WILL MAKE THEM GO A LOT
FASTER ANYWAY AND WE NEED FAST
ANSWERS.
THANKS.
>> THANK YOU.
OTHER COMMENTS OR QUESTIONS,
PLEASE?
YES, BRIAN, PLEASE GO AHEAD.
>> IT'S REALLY NICE TO HEAR THE
UPDATE ABOUT THIS IMPORTANT
INITIATIVE.
I WONDER IF YOU COULD TALK A
LITTLE BIT MORE ABOUT THE ROLE
OF SOCIAL, BEHAVIORAL AND MENTAL
HEALTH SCIENCE IN THE RECOVER
INITIATIVE.
I FEEL LIKE, YOU KNOW, AS YOU
WERE DESCRIBING IT, IT SEEMED
LIKE MUCH THAT WAS DESCRIBED IS
FOCUSED ON PATHOBIOLOGY,
NEUROLOGY, PHARMACOLOGICAL
TREATMENTS, AND YOU KNOW, AS WE
UNDERSTAND LONG COVID, A LOT OF
THE KEY SYMPTOMS ARE
PATIENT-REPORTED OUTCOMES LIKE
FATIGUE, QUALITY OF LIFE IS
CERTAINLY VERY IMPORTANT FOR
UNDERSTANDING HOW TREATMENTS
IMPROVE PEOPLE WHO ARE LIVING
WITH THESE CONDITIONS.
THEN THERE'S ALSO A LOT OF
STRONG EVIDENCE THAT MENTAL
HEALTH CONDITIONS LIKE
DEPRESSION AND ANXIETY ARE
ANTECEDENTS AND SEQUELAE OF LONG
COVID.
SO I WONDER IF WE COULD TA TALKA
LITTLE BIT MORE ABOUT MENTAL
HEALTH RESEARCHERS, HEALTH
PSYCHOLOGISTS ARE INVOLVED IN
THE LEADERSHIP OF THIS
INITIATIVE OR THE WORKING
GROUPS.
>> SO I CAN SAY DEFINITELY THAT
THE COHORT DESIGNS INCLUDED AN
INCREDIBLY DIVERSE
MULTIDISCIPLINARY GROUP, BECAUSE
YOU HIT IT EXACTLY RIGHT, BRIAN.
WE HAD TO IDENTIFY -- THIS IS A
CLINICAL DIAGNOSIS.
AND YOU KNOW, HOW COULD YOU
POSSIBLY COME UP WITH AN
ADEQUATE AND, YOU KNOW,
APPROPRIATELY DESIGNED CLINICAL
DIAGNOSIS WITHOUT INVOLVEMENT OF
BEHAVIORAL SCIENTISTS, SOCIAL
SCIENCE, AND FRANKLY THOSE IN
THE CLINIC WHO ARE EXPERIENCED
IN TREATING SOME OF THESE
POST-INFECTIOUS SYNDROMES FOR,
YOU KNOW, FOR DECADES.
SO THAT WAS DEFINITELY IN PART
OF THE ORIGINAL COHORT DESIGNS.
AND WE HOPE TO CONTINUE TO
ENGAGE THAT FULL SPECTRUM OF
RESEARCHERS AS THE COHORTS
MATURE AND WE PROCEED TO
MAINTENANCE AND ANALYSIS.
I'LL JUST EMPHASIZE AGAIN THAT
ONE OF OUR STRUGGLES IS THAT AS
SOMETIMES HAPPENS WITH NIH, THE
FUNDING FOR THE RECOVER COHORTS
ARE ALL TIME-LIMITED.
AND SO ONE OF OUR CHALLENGES
HERE IS TO FIGURE OUT HOW WE ARE
GOING TO MAINTAIN THE TEAM THAT
HAS SO FAR CONTRIBUTED AS WE NOW
MATURE INTO THE DATA ANALYSIS
AND THE COHORT MAINTENANCE
PHASES, AS WELL AS THE CLINICAL
TRIALS.
>> THANK YOU.
>> IF I COULD JUST FOLLOW UP ON
THAT, INTERVENTION ST STUDIES TT
ARE BEING DONE, ARE WE
CONSIDERING BEHAVIORAL
INTERVENTIONS?
>> THE ORIGINAL -- THE ORIGINAL
SET OF STUDIES HAVE BEHAVIORAL
INTERVENTIONS WITHIN THEM.
I CAN'T GO INTO GREAT DETAILS,
BUT YOU WILL SEE WHEN YOU LOOK
AT THE -- WHAT HAPPENED IN THE
FIRST PLATFORM TRIALS, YOU WILL
SEE BEHAVIORAL INTERVENTIONS,
AND THEN THE STUDIES GOING
FORWARD, YOU SAW THE
PRESENTATION FROM RECOVER TLC,
AND SO STUDIES GOING FORWARD ARE
GOING TO BE -- ARE STILL BEING
PLANNED, AND I CERTAINLY --
YOU'VE SEEN THAT IN THE INITIAL
RESPONSE TO THE PORTAL.
MOST OF WHAT WE GOT WERE DRUG
TRIALS, BUT STILL THERE ARE SOME
BEHAVIORAL INTERVENTIONS IN
THERE.
AND I KNOW THE TEAM IS GOING TO
HAVE, FRANKLY, DIFFICULT
DECISIONS TO MAKE WITH THE
FUNDING AVAILABLE TO DECIDE
WHICH ONES ARE GOING TO HAVE
PRIORITY GOING FORWARD.
>> THANK YOU.
>> OKAY.
ADDITIONAL COMMENTS OR
QUESTIONS?
I KNOW WE'RE THE ONLY THING
STANDING BETWEEN YOU AND YOUR
LUNCH, IF YOU'RE HERE ON THE
EAST COAST.
SO -- BUT -- OR PERHAPS
BREAKFAST.
OTHER COMMENTS OR QUESTIONS?
I THINK THE POWER OF THE MEAL IS
TOO GREAT.
OKAY.
ALL RIGHT.
SO THANK YOU ALL.
SO WE ARE GOING TO NOW RECONVENE
AT 1:15 P.M. EASTERN TIME AFTER
THE LUNCH BREAK, AND SO WE LOOK
FORWARD TO SEEING EVERYBODY BACK
THEN. THANKS.
WELCOME BACK, EVERYBODY.
WE'RE MOVING TO OUR AFTERNOON
FOR THE ACD MEETING.
I AM REALLY EXCITED TO BE ABLE
TO HIGHLIGHT TWO EARLY CAREER
INTRAMURAL INVESTIGATORS FOR YOU
ALL TODAY.
WE'RE GOING TO START WITH DR.
CAITLIN STADLER, A STADTMAN
INVESTIGATOR, SECTION ON
BIOENGINEERING IN NIBIB.
>> THANK YOU SO MUCH, DR.
BERTAGNOLLI.
I APPRECIATE THE INVITATION TO
COME AND SHARE SOME WORK WE'VE
BEEN DOING IN THE INTRAMURAL
RESEARCH PROGRAM OF NIBIB.
OUR WORK LIES AT THE
INTERSECTION OF BIOMEDICAL
ENGINEERING AND IMMUNOLOGY
REALLY FOCUSED ON TRAUMATIC
INJURIES.
AND SO WHEN WE'RE TALKING ABOUT
TRAUMATIC INJURIES, YOU KNOW,
WHAT ARE WE GENERALLY REFERRING
TO?
AND THE ANSWER IS A WIDE VARIETY
OF THINGS.
FRACTURES, HEMATOMAS, BURNS,
FALLS, ANYTHING THAT CAUSES LOSS
OF TISSUE ARCHITECTURE, AND M
MORE SEVERE CASES THERE ARE DOWN
EXTREME EFFECTS ON TISSUE HEALTH
FROM ISCHEMIC DAMAGE AND MUSCLE
WASTING FROM AN INABILITY TO
COMPENSATE WITH OTHER MUSCLE
GROUPS THAT MAY BE LOST DUE TO
INITIAL TRAUMA.
THESE PATIENTS NOT ONLY HAVE
ISSUES WITH THEIR KIND OF LOCAL
TISSUE BUT THEY ALSO HAVE ISSUES
WITH MORE SYSTEMIC AND I DO
APOLOGIZE IF I'M IN FULL SCREEN
PRESENTATION, HOPEFULLY YOU CAN
SEE FULL SCREEN NOW.
MY MONITOR SWITCHED ON ME.
I APOLOGIZE FOR THAT.
SO THESE PATIENTS ALSO SUFFER
FROM SYSTEMIC IMMUNE ACTIVATION
AND IMMUNOSUPPRESSION CONDITIONS
AS WELL.
AND SO TISSUE ENGINEERING AND
REGENERATIVE MEDICINE, OLD
FIELDS FORMED WITH THE GOAL OF
BUILDING BACK TISSUES AND
REPAIRING WHAT WAS LOST.
WHO EXACTLY ARE OUR PATIENTS
HERE WHEN WE'RE TALKING ABOUT
THESE TRAUMATIC INJURIES?
WE HAVE SOLDIERS, CIVILIANS IN
COMBAT ZONES, FARMERS,
MANUFACTURING PROFESSIONALS
WORKING WITH HEAVY MACHINERY, WE
HAVE INJURIES IN CIVILIANS FROM
EXPLOSIVES AND CAR ACCIDENTS AND
THEN OTHER THINGS THAT YOU MIGHT
NOT THINK OF AS A TRAUMATIC
INJURY SUCH AS CHILD BIRTH THAT
CAUSE SEVERE TISSUE DAMAGE.
AND OVERALL WHEN WE LOOK AT THE
POPULATION WITHIN THE UNITED
STATES, THESE PROBLEMS THAT
WE'RE DEALING WITH ARE
WIDESPREAD.
TRAUMATIC INJURY IS THE
LEADING -- FOURTH LEADING CAUSE
OF DEATH OVERALL AND LEADING
CAUSE OF DEATH FOR THOSE UNDER
45 YEARS OF AGE IN THE UNITED
STATES.
AND THIS WAS REALIZED AS A
PROBLEM IN 2016, EMISSION ZERO
WAS THE GOAL OF GETTING
PREVENTIBLE DEATHS DOWN BUT THEY
ARE HIGHER NOW.
WORKING IN EMERGENCY MEDICINE
THEY MEET PATIENTS ON THE WORST
DAY OF THEIR LIFE.
IF THEY SURVIVE THE ROAD TO
RECOVERY FROM TRAUMA HAS A VERY,
VERY LONG ROAD.
WE HAVE ISSUES WITH DONOR SITE
MORBIDITY FROM GRAPHS, LIMITED
AVAILABILITY OF DONOR ORGANS.
PEOPLE ARE AWARE OF SHORTAGES IN
THE UNITED STATES.
AS A SHEER FACT OF NUMBERS, IN
THE U.S. WE HAVE 24.8 MILLION
ACCIDENTAL TRAUMAS AND 60
MILLION SURGERIES WHICH ALSO
CAUSE TRAUMATIC INJURIES PER
YEAR IN THE U.S. ALONE.
WHEN LOOKING AT THE SURGICAL
REPAIR OF THESE TISSUES AFTER
TRAUMA, IT'S NOT JUST STITCHING
A PATIENT UP.
FREQUENTLY SURGEONS ARE USING
DIFFERENT MATERIALS TO HELP HEAL
THESE INJURIES.
SO, FOR EXAMPLE, THERE ARE
BIOLOGIC PRODUCTS FOR WOUND
REPAIR.
THIS IS A COLLAGEN BASED
MATERIAL, ECM, HERE IT'S APPLIED
TO A DIABETIC FOOT ULCER, ALSO
USED FOR LARGER SCALE INJURIES.
HERE A SOLDIER HIT WITH AN IED
BLAST, ON THE RIGHT THERE'S A
REGROWTH OF MUSCLE TISSUE AFTER
TREATMENT WITH ECM MATERIAL.
OTHER IMPLANTS ARE NOT
NECESSARILY MADE TO BE REPLACED
BY THE PATIENT'S OWN TISSUE.
THINGS LIKE SYNTHETIC BREAST
IMPLANTS, MEDICAL DEVICES FOR
RECONSTRUCTION.
SO THIS IS AN EXAMPLE OF A MORE
NEGATIVE IMMUNE RESPONSE AGAINST
THESE MEDICAL DEVICES WHERE YOU
GET SCAR TISSUE FORMATION AND
FIBROTIC ENCAPSULATION OF THE
DEVICE THAT'S BEEN IMPLANTED.
AS MENTIONED BEFORE EVEN
CONTROLLED SURGERIES CAUSE
TRAUMA.
WHEN WE'RE GOING TO IMPLANT
MEDICAL DEVICES IT'S NOT JUST IN
THE CONTEXT OF TRAUMATIC
INJURIES BUT ALL SURGICAL
IMPLANTATIONS AS GIVING TISSUE
DAMAGE.
WHEN WE THINK OF THESE DEVICES
WE NEED TO THINK OF THEM IN THE
CONTEXT OF DAMAGED TISSUE.
SO WITHIN NIBIB HERE AT NIH OUR
SECTION ON IMMUNOENGINEERING,
WE'RE ENGINEERS, IMMUNOLOGISTS,
BIOLOGIST, A LARGE
INTERDISCIPLINARY TEAM.
WE WORK ON FUNDAMENTAL
IMMUNOLOGIC DISCOVERIES TRYING
TO UNDERSTAND HOW THE IMMUNE
SYSTEM RESPONDS TO INJURY,
RESPONDS TO MEDICAL DEVICES THAT
GET IMPLANTED.
AND USE THAT KNOWLEDGE TO
DEVELOP NEW THERAPEUTICS FOR
MATERIALS IN TRAUMA AND
REGENERATION.
NOW, OF COURSE, ALL OF THIS IS
ON A BEDROCK OF CLINICAL
DISCOVERY AND TRANSLATION
BECAUSE WE WANT TO FOCUS IN ON
MAKING MATERIALS THAT HELP
PEOPLE.
SO I'M GOING TO CHAT A LITTLE
BIT ABOUT ONE OF THOSE CLINICAL
PROJECTS WE HAD EARLY ON, ABLE
TO BRANCH OFF OF SOME COVID
RESEARCH THAT WE DID DURING THE
FIRST TWO YEARS WHERE OUR LAB
WAS HERE.
AND THIS WAS A LARGE
MULTI-CENTER COLLABORATION WITH
FIVE DIFFERENT TRAUMA CENTERS IN
THE UNITED STATES.
WE WERE ABLE TO GET OFF THE
GROUND THIS THOUSAND-PATIENT
COHORT STUDY LOOKING AT HUMAN
IMMUNE RESPONSES TO TRAUMATIC
INJURY.
WHAT WE DID WAS WOUND UP LOOKING
AT THESE PATIENTS WITH A VARIETY
OF TRAUMA SOURCES, AND WE
EVALUATED 59 PROTEINS IN THEIR
BLOOD AT THE TIME OF ADMISSION.
AND WE EXCITINGLY FOUND NEW
TRAUMA RESPONSE PROTEINS.
THEY HAVE NEVER BEEN PREVIOUSLY
REPORTED IN THE CONTEXT OF
TRAUMATIC INJURY.
ONE THAT WAS REALLY EXCITING WAS
THIS PROTEIN IL-29, A RELATIVELY
NEW CYTOKINE, HASN'T BEEN
REPORTED BEFORE IN TRAUMA.
WHAT WAS EVEN MORE INTERESTING
WAS IT WAS ACTUALLY PREDICTIVE
OF SURVIVAL.
IF WE GO THROUGH THOSE PROTEINS
AND DATA, USING MACHINE LEARNING
AND BASIC ALGEBRA WE CAN DEVELOP
NEW EQUATIONS TO PREDICT
SURVIVAL.
THIS IS AN EXAMPLE, VIPER, IN
REVISION, SO NEW DATA AND WE'RE
EXCITED ABOUT LEARNING FROM THE
BIOLOGY OF THESE PROTEINS AND
THEN THE FACT THIS MIGHT BE ABLE
TO BE USED AS A DIAGNOSTIC.
AS I MENTIONED BEFORE, TRAUMA
AFFECTS A PATIENT SYSTEMICALLY,
ALSO WITHIN THAT LOCAL INJURED
TISSUE.
CLINICAL WORK WAS LOOKING AT
SYSTEMIC, AT THE PERIPHERAL
BLOOD.
BUT WE REALLY DO NEED TO ZOOM
INTO THAT LOCAL TISSUE TO START
LEARNING ON HOW TO RECONSTRUCT
IT.
AND SO THIS IS WHERE ANOTHER SET
OF OUR GROUP, WHERE WE WORK ON
PRE-CLINICAL MODELS COMES INTO
PLAY STUDYING IN DETAIL WHAT
IMMUNE CELLS ARE DOING IN THAT
INJURY.
SO WE FOCUS IN ON SKELETAL
MUSCLES, TISSUE WE WORK ON, SO
HERE IS A SCHEMATIC OF ALL OF
THE -- A BUNCH OF IMMUNE CELLS
INVOLVED IN TRAUMATIC MUSCLE
INJURY AND REPAIR.
WE HAVE EARLY ON INFLAMMATORY
SIGNALS LIKE THIS PROTEIN
INTERFERON GAMMA CAN STIMULATE
STEM CELL PROLIFERATION TO BUILD
NEW TISSUE.
DOWN THE LINE THERE'S A SWITCH
IN IMMUNE RESPONSES WHERE THIS
HEADS TOWARD A REGULATORY IMMUNE
RESPONSE, DIFFERENT IMMUNE CUES
WITH SIGNAL STEM CELLS TO FUSE
INTO MYOTUBES AND FORM MUSCLE
FIBER.
ONE THING THAT WAS BOTHERING US
EARLY ON WHEN YOU THINK OF
TRAUMATIC INJURY THERE'S A
MASSIVE DISTURBANCE IN
HOMEOSTASIS.
WE HAVE ALL SORTS OF THINGS IN
THERE.
BACTERIA, DEBRIS, PROTEINS ON
THE OUTSIDE OF CELLS THAT SHOULD
BE ON THE INSIDE.
AND SO JUST THINKING ABOUT THE
BIOLOGY WE HAVE THIS PERSISTENT
INFLAMMATION THAT GOES ON FOR
MONTHS.
HOW DO WE NOT GET AUTOIMMUNITY,
HOW HAVE OUR BODIES DEVELOPED
WAYS TO PREVENT THIS AND COULD
WE LEVERAGE FOR THERAPEUTICS?
WE GO INTO THE LABORATORY WE
START LOOKING AT OUR VOLUMETRIC
MUSCLE LOSS VML MODEL TO ANSWER
THESE QUESTIONS.
THIS IS A SURGICAL EXCISION
MODEL OF SKELETAL MUSCLE INJURY.
WE USE TWO POLLS OF IMMUNE
RESPONSE TO BIOMATERIALS.
ONE BEING GOOD MATERIAL WHERE
OUR PRO HEALING MATERIAL THAT
ECM I MENTIONED PREVIOUSLY USED
CLINICALLY THAT HELPS HEAL THE
WOUND.
ON THE OTHER SIDE WE IMPLANT
POLYETHYLENE, AND SO THIS IS OUR
BAD MATERIAL.
IT'S WONDERFUL WHEN IT'S SOLID
AND TOGETHER IN A MEDICAL DEVICE
BUT WHEN YOU GET TINY WEAR
PARTICLES YOU HAVE LOTS OF
INFLAMMATION, FIBROSIS,
SCARRING.
IF WE CAN UNDERSTAND WHAT MAKES
THE GOOD GOOD AND WHAT MAKES THE
BAD BAD, WE CAN START TO TRY TO
IDENTIFY THESE TARGETS FOR
THERAPEUTICS.
WE STARTED OUT WITH A REALLY
STRAIGHTFORWARD QUESTION.
WHAT HAPPENS TO WOUNDS WITHOUT
IMMUNOLOGIC SELF-TOLERANCE?
THIS MEANS WHAT HAPPENS IN CASES
OF KNOWN AUTOIMMUNITY.
SO WHEN WE LOOK INSIDE THESE
MICE THAT LACK THIS PROTEIN, IT
IS NEEDED FOR THIS PROCESS OF
TELLING OUR BODY NOT TO ATTACK
ITSELF.
WHEN THIS PROTEIN IS GONE WE
HAVE AUTOIMMUNITY.
SO LET'S LOOK INSIDE THE AIR
KNOCKOUT MICE.
WILD TYPE ON LEFT, PINK IS
MUSCLE TISSUE AT THE TOP OF THE
IMAGE, IMPLANTED WITH THAT MORE
PRO-INFLAMMATORY MATERIAL.
WE SEE A REALLY STRONG AND
ROBUST INFLAMMATION.
HOWEVER IF WE LOOK AT IMAGES ON
THE RIGHT SIDE WE CAN SEE IN
AUTOIMMUNE MICE MASSIVELY
EXPANDED IN PRESENCE OF THIS
PLASTIC.
AND THAT'S CONFIRMED WITH THE CD
45 IMMUNE MARKER BELOW.
SO CONCLUSION FROM THAT
EXPERIMENT IMMUNE CELLS
TOLERATE, CRITICAL IN MATERIAL
IMPLANTATION.
DIGGING FURTHER WHAT ARE SOME
MECHANISMS OF MAINTAINING THIS
IMMUNOLOGIC TOLERANCE IN, SAY,
NORMAL MICE.
THIS IS A PAPER WE HAD PUBLISHED
RECENTLY.
WE FOCUSED ON THIS IMMUNE CELL,
KNOWN TO HELP PROMOTE THIS CELL
TOLERANCE IN THE LITERATURE.
WHEN WE LOOKED AT THE MODEL WE
WERE EXCITED TO SEE WITH THE PRO
HEALING MATERIAL WE SAW
ENRICHMENT OF THIS IMMUNE CELL
TYPE FOR THIS TOP RIGHT CORNER
OF THE GRAPH IN TEAL.
IN THAT PRO HEALING MATERIAL.
WE DIDN'T GET THE SAME
ENRICHMENT WITH THE
PRO-INFLAMMATORY MATERIAL.
LOOKING DOWN THE LINE WE SAW
THESE CDC 1s COULD AFFECT
HELPER T-CELL ACTIVATION WHICH
IS KNOWN TO BE IMPORTANT IN
MUSCLE REGENERATION.
AND THEN ALSO M2 MACRO MAJOR
POLARIZATION IMPORTANT IN
REGENERATION AND ALSO REMODELING
OF THAT SCAFFOLD INTO NEW
TISSUE.
THAT BEING SAID WHEN WE LOOK AT
THE TISSUE ITSELF IN MICE THAT
DON'T HAVE THESE CDC 1s, WE
SEE IMBALANCES IN STEM CELL
DIFFERENTIATE.
SO WE LACK THESE CELLS, WE HAVE
ISSUES WITH MUSCLE DEVELOPMENT,
TISSUE CALCIFICATIONS.
STEM CELLS AREN'T GETTING RIGHT
IMMUNE CUES TO DEVELOP INTO
TISSUE THEY NEED TO BE.
SO NOW WE LOOK BEFOREHAND AND
SEE WHAT IS MAKING THESE CELLS
COME IN.
WE TOOK SOME INSPIRATION FROM
CANCER LITERATURE THAT SHOWED
NATURAL KILLER CELLS COULD
RECRUIT CD 1, WHY NOT WOUNDS,
THE MECHANISM IS EXACTLY THE
SAME.
WE SEE THESE NATURAL KILLER
CELLS WHEN STIMULATED WITH
SIGNALS OF TISSUE DAMAGE,
UPREGULATES.
WE'VE IDENTIFIED A PATHWAY FOR
SELF-TOLERANCE AND IMMUNOREGULAR
NATION, EXCITED TO INVESTIGATE
NEW PATHWAYS.
SO LOOKING FAR FORWARD IN THE
FUTURE I'M STILL EARLY CAREER,
I'VE BEEN HERE FIVE YEARS, VERY
EXCITED AS TO THE WAY THAT THIS
FIELD AS A WHOLE, NOT JUST OUR
LAB BUT OTHERS WORKING IN IT
COULD AFFECT MEDICINE.
THIS WILL IMPROVE OUR
UNDERSTANDING OF HOW THE IMMUNE
SYSTEM RESPONDS TO TRAUMATIC
INJURY, GENERATING NEW
PREDICTORS AND DIAGNOSTICS FOR
PATIENT SURVIVAL, NEW MEDICAL
DEVICES, MEDICAL DEVICE CODING
TO EXTEND LIFETIME OF DEVICES.
AND LEARNING ABOUT WOUND HEALING
USING THIS KNOWLEDGE FOR OTHER
FIELDS SUCH AS AUTOIMMUNE
CONDITIONS, PLACES WE MIGHT BE
EXPOSED TO PLASTICS,
MICROPLASTICS ARE DISCUSSED NOW.
WE HAVE A BROAD COLLABORATION,
MASSIVE -- THANKS TO EVERYBODY
WE COLLABORATE WITH, WE'RE
EXCITED TO WORK ACROSS NIH
INTRAMURAL RESEARCH PROGRAMS,
DEPARTMENT OF DEFENSE, ALSO OUR
ACADEMIC COLLABORATORS.
WITH THAT I'D LIKE TO THANK
EVERYONE IN MY LABORATORY AS
WELL AS OUR EXTERNAL
COLLABORATIONS, COLLABORATORS,
TRAUMA PATIENTS AND THEIR
FAMILIES, OF COURSE THE FUNDING
THAT WAS PROVIDED FROM THE NIBIB
INTRAMURAL RESEARCH PROGRAM.
I'M HAPPY TO TAKE ANY QUESTIONS
WHEN THE TIME PERMITS.
THANK YOU.
>> WELL, THANK YOU.
WE HAVE LITERALLY TIME FOR ONE
OR MAYBE TWO VERY QUICK
QUESTIONS.
MONICA, DID YOU WANT TO START?
>> GO AHEAD.
>> ANYBODY HAVE A QUICK
QUESTION?
WE'RE STRAINED FOR TIME HERE.
>> I'LL GO QUICK.
THIS IS THE ADVISORY BOARD TO
THE COMMITTEE TO THE DIRECTOR.
ANY THOUGHTS YOU HAVE ABOUT
BEING A JUNIOR INVESTIGATOR AND
KIND OF THE ROLE AT NIH?
>> I'D SAY BEING A JUNIOR
INVESTIGATOR HERE, ONE THING
I'VE ENJOYED IS DOING
HYPOTHESIS-DRIVEN RESEARCH,
EXCITING NEW DIRECTIONS WHERE I
CAN DO THE SCIENCE AND SHOW THAT
I WAS ABLE TO DO IT AS OPPOSED
TO, YOU KNOW, THE GRANT-BASED
MECHANISM ON THE OUTSIDE AND
THEN OF COURSE WE'RE WORKING
WITH, YOU KNOW, FUNGAL DISEASE
RESEARCHERS, WITH TRAUMA
SURGEONS, WORKING WITH CANCER
RESEARCHERS, BASIC
IMMUNOLOGISTS, AND NOT BEING
SILOED WITHIN FIELDS I THINK HAS
BEEN VERY, VERY HELPFUL IN TERMS
OF THE SCIENCE THAT WE DO.
AND SO THOSE TWO THINGS COMBINED
BEING ABLE TO DO THE SCIENCE
THAT, YOU KNOW, WE THINK NEEDS
TO BE DONE AND THEN HAVING THE
INTERDISCIPLINARY COLLABORATION
HAS BEEN REALLY WONDERFUL.
>> EXCELLENT.
THAT'S WHAT WE'RE TRYING TO
ACHIEVE.
THANK YOU SO MUCH.
THANK YOU FOR BEING HERE.
OKAY.
NEXT, DR. KEENAN WALKER, WHO AN
NIH DISTINGUISHED SCHOLAR,
MULTI-MODAL IMAGING OF
NEURODEGENERATIVE DISEASE UNIT
IN THE NATIONAL INSTITUTE OF
AGING.
DR. WALKER.
>> OKAY.
FIRST, THANK YOU FOR HAVING ME.
HOPEFULLY YOU'RE SEEING MY
SCREEN, THE RIGHT SCREEN AND CAN
HEAR ME WELL.
>> GOOD.
>> AWESOME.
I'M KEENAN WALKER, NIA.
I'VE BEEN AT NIA FOR ABOUT FOUR
YEARS.
I'M GOING TO TALK ABOUT
UNDERSTANDING THIS LINK BETWEEN
INFECTION AND DEMENTIA RISK AND
UNDERSTANDING THE MOLECULAR
CONNECTION THERE.
SO, I'LL FOCUS FIRST TO GET
EVERYONE ON THE SAME PAGE ON
ALZHEIMER'S DISEASE WHICH WE
KNOW AFFECTS OVER 10% OF
INDIVIDUALS IN THE U.S., OVER
AGE 65.
IT'S THE MOST COMMON FORM OF
DEMENTIA.
THERE'S MANY FORMS OF DEMENTIA
BUT ALZHEIMER'S DISEASE PRESENTS
2/3, IT'S CHARACTERIZED BY
BIOLOGICALLY BY EXTRACELLULAR
AMYLOID PLACENTAL PERFUSION,
INTRACELLULAR TANGLES, AND A
HOST OF OTHER NEUROBIOLOGIC
PROCESSES LIKE MICROGLIAL
ACTIVATION, NEUROINFLAMMATION.
BUT THERE'S ALSO OTHER THINGS
THAT INFLUENCE DEMENTIA RISK OR
ALZHEIMER'S DISEASE RISK.
FOR EXAMPLE, SYSTEMIC HEALTH
CONDITIONS, THESE ARE CONDITIONS
THAT OCCUR OUTSIDE THE CENTRAL
NERVOUS SYSTEM, LIKE DIABETES,
HYPERTENSION, SYSTEMIC
INFLAMMATORY OR METABOLIC
CONDITIONS, EPIDEMIOLOGIC,
TRANSLATIONAL RESEARCH
DEMONSTRATE INCREASED RISK FOR
DEMENTIA AND ALZHEIMER'S,
SPECIFICALLY.
AND WHAT OF THE LARGE
CATEGORIES, WHAT WE STUDY IN THE
MIND UNIT, EFFECT OF ONE SUCH
CONDITION OR TYPE OF CONDITION,
THAT'S AFFECTING THE IMMUNE
SYSTEM, OUTSIDE THE CENTRAL
NERVOUS SYSTEM.
AND OUR HYPOTHESIS, THERE'S BEEN
QUITE A BIT OF WORK TO SHOW THAT
PERIPHERAL IMMUNE FUNCTION AND
DYSFUNCTION CAN INFLUENCE ONE'S
RISK FOR ALZHEIMER'S DISEASE.
I LIKE TO CLASSIFY PERIPHERAL
IMMUNITY INTO TWO DIFFERENT
CATEGORIES IN TERMS OF
INFLAMMATORY INSULTS.
SO, ON THE LEFT WE HAVE CHRONIC
IMMUNE ACTIVATION WHICH COMES
FROM ELECTRONIC AUTOIMMUNE
CONDITIONS, CHRONIC INFECTION,
LIFESTYLE CHOICES.
AND ON THE RIGHT WE HAVE ACUTE
INFLAMMATORY CONDITIONS THAT
COME FROM TISSUE INJURY, ACUTE
INFECTION, CRITICAL ILLNESS, FOR
EXAMPLE.
AND THE THING THAT THESE TWO
TYPES OF IMMUNE INSULTS HAVE IN
COMMON IS THAT THEY UPREGULATE
INFLAMMATORY MEDIATORS, MAKING
THE WAY FROM TISSUE INTO
CIRCULATION AND THEN CAN
INFLUENCE TARGET CELLS WITHIN
THE BRAIN THROUGH VARIOUS
CONDUITS, THROUGH THE
BLOOD-BRAIN BARRIER FOR EXAMPLE,
FORWARD PLEXUS, SIGNALING VIA
THE AFFERENT VAGAL NERVE
SIGNALING.
THESE INFLAMMATORY PROTEINS IN
CIRCULATION IN BLOOD EXERT QUITE
A BIT OF EFFECT ON BRAIN
FUNCTION.
AND THIS IS REALLY FOR US THE
FOREFRONT WITH THE COVID-19
PANDEMIC.
IT'S BEEN WIDELY ACCEPTED THAT
INFECTION OR ACUTE INFLAMMATORY
INSULT CAN HAVE LONG-TERM
EFFECTS ON BRAIN HEALTH AND HAVE
BEEN ASSOCIATED WITH DEMENTIA
RISK IN THE PAST.
BUT I THINK IT'S BECOME VERY
WELL RECOGNIZED EVER SINCE COVID
AND IT'S THOUGHT TO BE WHAT
UNDERLIES A LOT OF
MANIFESTATIONS OF LONG COVID,
PARTICULARLY THAT AFFECTS BRAIN
HEALTH, COGNITION, DEMENTIA
RISK, PSYCHIATRIC CONDITIONS, ET
CETERA.
SO WE SET OUT TO REALLY
UNDERSTAND THE MOLECULAR LENGTH
BETWEEN INFECTION AND COGNITIVE
DECLINE AND DEMENTIA RISK NOT IN
COVID SPECIFICALLY BUT ACROSS
INFECTIONS BECAUSE WE THINK
THERE'S MORE SIMILARITIES ACROSS
INFECTIONS DRIVING THIS
MECHANISM THAN THERE ARE
DIFFERENCES.
SO THIS WAS A PAPER THAT WAS
PUBLISHED BY MICHAEL DUGGAN, MY
POSTDOC, THIS CAME OUT IN NATURE
AGING.
WE TRIED TO TEST THIS HYPOTHESIS
THAT'S ILLUSTRATED IN THE
DIAGRAM AT THE BOTTOM.
WHEN WE HAVE INFECTION, THE IDEA
IS THAT INFECTION IS ASSOCIATED
WITH ABNORMAL EXPRESSION OF
PROTEINS IN CIRCULATION.
THESE PROTEINS ARE EMERGING FROM
TISSUES ACROSS THE BODY.
ONCE THEY GET IN CIRCULATION THE
IDEA IS THEY CAN INFLUENCE
MOLECULAR CHANGES WITHIN THE
BRAIN TO VARIOUS CONDUITS, AS
MENTIONED BEFORE.
SOME OF THESE INCLUDE HALLMARKS
OF ALZHEIMER'S, ACCELERATING TO
DEMENTIA RISK.
WE TRIED TO TEST MOST OF THE
CONNECTIONS IN THIS CAUSAL OR
MECHANISTIC CHAIN HERE.
WE STARTED BY LOOKING AT THIS
RELATIONSHIP BETWEEN PAST
INFECTION AND NEURODEGENERATION.
AND TO DO THIS WE USED DAD FROM
LEGISLATURE LONGITUDINAL STUDY
OF AGE, CONDUCTED OUT OF THE NIA
INTRAMURAL RESEARCH PROGRAM AND
ONE OF THE LONGEST RUNNING AGING
COHORT STUDIES IN THE UNITED
STATES, STARTED BACK IN THE
40s OR 50s I BELIEVE.
WHAT WE DID WAS LOOKED AT
HISTORY OF INFECTION IN RELATION
TO BRAIN VOLUME LOSS BECAUSE WE
HAVE QUITE A BIT OF BRAIN VOLUME
DATA AND COGNITIVE DATA.
WHAT WE FOUND WAS THAT PEOPLE
WITH HISTORY OF CERTAIN SET OF
INFECTIONS TEND TO SHOW GREATER
BRAIN ATROPHY IN SUBSEQUENT
YEARS.
SO RESULTS FROM INFLUENZA, SKIN
INFECTION, TWO OF SEVERAL TYPES
WE LOOKED AT.
WITH INFLUENZA THOSE INDIVIDUALS
DO SHOW GREATER VOLUME LOSS IN
TEMPORAL REGIONS AND OCCIPITAL
REGIONS.
THOSE WITH HISTORY OF SKIN
INFECTIONS TEND TO HAVE GREATER
VOLUME LOSS IN TOTAL BRAIN
VOLUME AND TOTAL GRAY MATTER.
OVERALL YOU SEE THE TREND ACROSS
VARIOUS BRAIN REGIONS FOR
DECREMENT AND VOLUME WITH TIME
POST-INFECTION.
THIS CAN BE MANY YEARS
POST-INFECTION.
THE AVERAGE DURATION BETWEEN THE
ASCERTAINMENT OF INFECTION AND
WHEN WE STARTED LOOKING AT BRAIN
VOLUME LOSS ON MRI WAS OVER TEN
YEARS.
SO THESE ARE REMOTE INFECTIONS.
THESE ARE INFECTIONS SEVERE
ENOUGH TO BE CLASSIFIED IN ICD-9
CODES, IMPORTANT CAVEAT.
THIS HAS EXPANDED BEYOND SKIN
INFECTIONS.
HERE ARE A NUMBER OF OTHER -- WE
LOOKED AT 15 IN TOTAL, AT LEAST
SIX SHOWED ASSOCIATION WITH
SUBSEQUENT BRAIN VOLUME LOSS.
INCLUDING HERPES VIRUS, VIRAL
INFECTIONS, UPPER AND LOWER
RESPIRATORY TRACT INFECTIONS.
SO, WE TOOK THESE SIX INFECTIONS
AFTER SHOWING ASSOCIATION WITH
VOLUME LOSS, AND THEN WE ASKED
WHETHER OR NOT THEY WERE
ASSOCIATED WITH SUBSEQUENT
DEMENTIA.
THE EXPRESSION OR END STAGE OF
VOLUME LOSS.
WE DID THIS IN A LARGER COHORT.
WE WORKED WITH THE U.K. BIOBANK,
MULTI-COHORT CONSORTIA IN
FINLAND, WERE ABLE TO USE ICD-9
AND ICD-10 CODE TO RELATE
INFECTION GROUPINGS TO DEMENTIA
RISK OVER SUBSEQUENT 10 TO 15
YEARS AND SAW INFLUENZA AND ALL
BUT ONE ASSOCIATED WITH
INCREASED RISK FOR ALL-CAUSE
DEMENTIA IN THE SUBSEQUENT U.K.
BIOBANK, 16 YEARS OF FOLLOW-UP.
WE WERE ABLE TO LOOK AT
ALZHEIMER'S DISEASE AND VASCULAR
DEMENTIA SPECIFICALLY, AND IN
SOME CASES SOME INFECTIONS
ACTUALLY SHOWED GREATER OR WERE
SOME GREATER RISK FACTORS FOR
VASCULAR DEPARTMENT THAN
ALZHEIMER'S, WHICH WAS
INTERESTING.
WE SAW SOMETHING SIMILAR IN THE
FINNISH MULTI-COHORT, EFFECTS
ATTENUATED, WORKING WITH HALF A
SAMPLE SIZE AS WELL.
AFTER ESTABLISHING THIS SET OF
SIX INFECTIONS IS ASSOCIATED
WITH VOLUME LOSS AND DEMENTIA
RISK, WE TO CHARACTERIZE THE
PROTEOMIC SIGNATURE THAT
UNDERLIES THESE INFECTIONS.
WE USED A PLATFORM CALLED
SOMASCAN, 7,000 PROTEINS, IN THE
BALTIMORE LONGITUDINAL STUDY OF
AGING.
OF THE 7,000 PROTEINS WE FOUND
900 WERE IMMUNE RELATED.
WE FOCUSED ON THESE 900 IMMUNE
PROTEINS AND FOUND THAT PEOPLE
WITH HISTORY OF THE INFECTIONS
THAT WE HAD BEEN FOCUSING ON DID
HAVE THIS DIFFERENTIAL
EXPRESSION IN THEIR BLOOD
PROTEOME.
WHAT'S HIGHLIGHTED HERE ARE A
SET OF PROTEINS DIFFERENTIALLY
EXPRESSED, THOSE WITH REMOTE
HISTORY OF SKIN INFECTION ON THE
RIGHT, YOU MIGHT RECOGNIZE THE
PROTEINS, SOME HAVE ALREADY BEEN
IMPLICATED IN DEMENTIA
PREVIOUSLY.
WE SEE ApoE TREND HERE
SOMEWHERE, AND WE DID THIS FOR
BROADER SET OF INFECTIONS AND
SAW FOR EACH THERE WAS PROTEOMIC
SIGNATURE, SOME DEGREE OF
OVERLAP BUT A LOT OF
INFECTION-SPECIFIC PROTEINS AS
WELL.
A LOT OF UNIQUENESS THERE.
AND DUPLICATES ARE HIGHLIGHTED
IN THE HEAT MAP ON THE RIGHT.
AFTER ESTABLISHING
INFECTION-RELATED PROTEINS SET
OUT TO FIND MOLECULAR MEDIATORS.
SO THEY HAD TO MEET CRITERIA.
ONE WAS THEY HAD TO BE
DIFFERENTIALLY EXPRESSED
POST-INFECTION.
SECOND WAS THEY HAD TO BE
PREDICTIVE OR ASSOCIATED WITH
SUBSEQUENT BRAIN VOLUME LOSS OR
BRAIN ATROPHY.
SO, WE THOUGHT THAT THIS -- IF
THEY MET THE CRITERIA THEY WERE
POTENTIAL CANDIDATES FOR BEING
INTERMEDIARIES BETWEEN INFECTION
AND BRAIN VOLUME LOSS AND
SUBSEQUENT DEMENTIA RISK.
SO WE THEN RELATED PROTEINS TO
MOLECULAR MEASURES OF
ALZHEIMER'S AND DEGENERATION.
WE'LL GO BACK TO INFLUENZA AS AN
EXAMPLE.
SO WHAT YOU'RE SEEING IN THE
PLOT, TOP RIGHT, ARE THE VARIOUS
PROTEINS, WHAT WE'RE CALLING
CANDIDATE PROTEINS BOTH
ASSOCIATED WITH HISTORY OF
INFECTION AND WITH SUBSEQUENT
BRAIN VOLUME CHANGES.
SO TOP LEFT ARE PATHOGENIC
PROTEINS, UPREGULATED IN PEOPLE
WITH HISTORY OF INFLUENZA AND
ASSOCIATED WITH FUTURE BRAIN
VOLUME LOSS.
BOTTOM RIGHT PROTECTIVE PROTEINS
DO YOU REGULATED POST-INFLUENZA
AND THEMSELVES ASSOCIATED WITH
STABLE BRAIN VOLUME OVER TIME
AND TOOK PROTEINS FROM BOTH
QUADRANTS, AND LOOKED AT
RELATIONSHIP TO MOLECULAR
MEASURES OF ALZHEIMER'S DISEASE.
AND NON-SPECIFIC MEASURES AS
WELL.
THE PROTECTIVE PROTEINS ACTUALLY
DOWNREGULATED POST-INFECTION AND
BUT THEMSELVES SEEMED TO BE
ASSOCIATED WITH STABLE BRAIN
VOLUME ACTUALLY SHOWED STRONG
RELATIONSHIPS WITH BOTH
ALZHEIMER'S DISEASE SPECIFIC
MARKERS WHERE WE HAVE PROTECTIVE
PROTEINS ASSOCIATED WITH LOWER
P-TAU AND IN PLASMA SUGGESTIVE
OF LOWER CORTICAL AMYLOID.
PATHOGENIC SIDE NOT AS
CONSISTENT IN TERMS OF
RELATIONSHIP WITH MOLECULAR
CHANGES.
AND THAT WAS THE SAME FOR SKIN
INFECTION WHERE WE SEE MUCH MORE
CANDIDATES BUT TWO PATHOGENIC
AND ONE PROTECTIVE PROTEIN.
WE SEE INTERESTING DISCORDANCE
INCLUDING FOR IL-18 YEAR WHERE
IT'S ASSOCIATED WITH HISTORY OF
INFECTION BUT ALSO AT THE SAME
TIME ASSOCIATED WITH STABLE
BRAIN VOLUME OVER TIME.
DIDN'T KNOW WHAT TO MAKE OF
THOSE TWO IN THE DIAGONAL.
YES, THIS PARADIGM WAS APPLIED
TO EACH OF OUR INFECTIONS.
AND ONCE WE HAD A FULL SET OF
CANDIDATE PROTEINS WERE ABLE TO
APPLY TECHNIQUE CALLED TWO
SAMPLE MENDELIAN RANDOMIZATION,
TRYING TO ADDRESS THE CAUSAL
QUESTION WHETHER OR NOT THE
PROTEINS ARE MECHANISTICALLY
RELEVANT IN BRAIN ATROPHY.
SO WE WERE ABLE TO REALLY USE
OBSERVATIONAL DATA AND LOOK AT
THE GENETIC OVERLAP LIKE CODING
EXPRESSION AND VARIANTS THAT
INCREASED RISK FOR BRAIN ATROPHY
AND BASED ON THAT OVERLAP WERE
ABLE TO INFER THESE CAUSAL LINKS
BETWEEN SEVERAL PROTEINS AND
BRAIN ATROPHY THAT WE THINK
UNDERLIES DEMENTIA RISK.
ESPECIALLY FOR SKIN SUBCUTANEOUS
AND INFLUENZA PROTEINS WHERE WE
SAW EVIDENCE OF CAUSALITY AND
FOR A NUMBER DIDN'T SEE
EVIDENCE.
THEY MAY JUST BE ASSOCIATIVE OR
REPRESENT BIOMARKERS RATHER THAN
MECHANISTIC TARGETS.
WE PULL THIS TOGETHER.
WE HAVE A NUMBER OF CANDIDATE
PROTEINS THAT ARE BOTH
ASSOCIATED WITH HISTORY OF
CERTAIN INFECTIONS AND
PREDICTIVE OF FUTURE BRAIN
VOLUME LOSS AND COULD PUT IT
TOGETHER IN THIS SORT OF PATHWAY
WHERE WE HAVE INFECTION LEADING
TO UPREGULATION OF PATHOGENIC
PROTEINS AND DOWNREGULATION OF
PROTECTIVE PROTEINS.
WE SAW STRONG EVIDENCE HERE FOR
THIS DOWNREGULATION AND
PROTECTIVE PROTEINS BEING
ASSOCIATED WITH GREATER AMYLOID
AND TAU, ALZHEIMER'S DISEASE
HALLMARKS, AND KNOW
DOWNREGULATION AND PROTECTIVE
PROTEINS IS ALSO ASSOCIATED WITH
ATROPHY.
PATHOGENIC PROTEINS, LESS CLEAR,
ASSOCIATED WITH BRAIN ACTIVITY
WHEN HIGHER BUT DOESN'T SEEM TO
BE THROUGH ALZHEIMER'S-SPECIFIC
PATHWAY BECAUSE WE DIDN'T SEE
ANY CONSISTENT RELATIONSHIP WITH
AMYLOID OR P TAU.
GOING BACK TO WHERE WE STARTED
WE HAVE A SET OF PROTEINS IN RED
HERE THAT WERE IDENTIFIED AS
POTENTIALLY CAUSAL AND, WELL,
MECHANISTIC MEDIATORS IN
INFECTION TO DEMENTIA INCLUDING
CYTOKINES, PATTERN RECOGNITION
RECEPTORS, CHEMOKINES AS WELL.
BUT WE'RE FOLLOWING UP WITH
THESE SPECIFIC PROTEINS TO TRY
TO REALLY UNDERSTAND WHAT THEY
MAY BE DOING TO THE CNS.
THERE'S ONE ALTERNATIVE
HYPOTHESIS THAT WE HAVE.
THIS WAS PROMPTED BY WHAT WE SAW
WITH PROTECTIVE PROTEINS BUT
THINK IT'S ALSO POSSIBLE THAT
THERE'S AN IMMUNE TRAIT THAT MIX
ONE MORE SUSCEPTIBLE TO
INFECTION AND MORE SUSCEPTIBLE
TO DEMENTIA.
AND THAT THE PROTEIN SIGNATURE
WE SEE IS AN EXPRESSION OF THAT
IMMUNE TRAIT SO YOU CAN IMAGINE,
YOU KNOW, SOMEONE WHOSE
MACROPHAGE MAYBE AREN'T AS
EFFECTIVE ALSO THE SAME PERSON
WHOSE MICROGLIA ARE LESS
SUSCEPTIBLE TO AMYLOID PLAQUES,
BOTH COULD BE POTENTIAL
EXPLANATIONS.
THANK YOU FOR LISTENING.
I WANT TO THANK -- SPECIAL
THANKS TO MICHAEL DUGGAN WHO LED
THIS HERCULEAN UNDERTAKING AND
THE REST OF THE COLLABORATORS AT
MY LAB, AND OF COURSE THE
FUNDING AND FOLKS AT NIA, GREAT
MENTORS AND COLLEAGUES.
THANK YOU.
I'M HAPPY TO TAKE QUESTIONS IF
THERE'S TIME.
>> THERE IS.
GREAT, THANK YOU.
IF WE COULD PULL UP THE FULL
GROUP OF FOLKS ON THE SCREEN.
YES, RUSS, LET'S START WITH YOU.
>> DR. WALKER, WONDERFUL
PRESENTATION, OBVIOUSLY HUGE
PUBLIC HEALTH PROBLEM AND
DISEASE WHERE WE HAVE SOME
PATHOLOGIC CLUES BUT NOT A LOT
OF MECHANISTIC CLUES, INTRIGUING
HYPOTHESIS.
TWO QUESTIONS.
ONE IS ONE OF THE CHALLENGES
WITH BIG DATA LIKE LONGITUDINAL
STUDY AT HOPKINS IS SPECIFICS TO
THAT STUDY POPULATION AND HOW
EASILY THESE FINDINGS CAN BE
TRANSLATED ACROSS OTHER
POPULATIONS.
U.K. BIOBANK IS A USEFUL
RESOURCE BUT HAS LIMITATIONS IN
TERMS OF QUALITY OF DATA AND
OBVIOUSLY THAT'S A DIFFERENT
POPULATION AS WELL.
HAVE YOU LOOKED AT, FOR EXAMPLE,
OTHER NIH-FUNDED CONSORTIA, I'M
THINKING SPECIFICALLY OF ADULT
CHANGES IN THOUGHT STUDY, WHICH
IS LONGITUDINAL PROSPECTIVE
STUDY OF PEOPLE WHO DEVELOP
DEMENTIA TO SEE WHETHER YOUR
RESULTS ON PRIOR INFECTION
REPLICATE THERE?
>> WE HAVEN'T LOOKED AT THAT
STUDY SPECIFICALLY BUT WORK
ACROSS COHORTS QUITE OFTEN.
IT'S ALMOST, YOU KNOW, THE RULE
RATHER THAN THE EXCEPTION.
ACTUALLY OUR USE OF PROTEOMICS
AND THE COHORT ADAPTION HAS MADE
IT EASY.
WE FIND A PROTEIN WE THINK IS
RELATED IN ONE COHORT AND A LOT
OF COHORTS HAVE THE SAME EXACT
PROTEOMIC PLATFORM, WE HAVE
REPLICATED INFECTION ASSOCIATION
WITH DEMENTIA IN THE U.K.
BIOBANK, BUT, YEAH, IT'S A GREAT
POINT.
U.K. BIOBANK IS MASSIVE AND
EXTREMELY HELPFUL.
BUT I THINK GENERALIZABILITY IS
ALWAYS A QUESTION.
>> YEAH, I THINK THE BROADER
CONCERN FOR THIS GROUP IS WHERE
YOU DO HAVE SO MUCH EMPHASIS
WITH CONGRESSIONAL EARMARKS FOR
ALZHEIMER'S RESEARCH AND SUCH A
RICH RESEARCH ENVIRONMENT, THERE
ARE A LOT OF OPPORTUNITIES FOR
REPLICATION AND CONFIRMATION AND
SYNERGY WHICH I DON'T SENSE ARE
FULLY MINED AT THIS POINT.
SOMETIMES THERE'S NOT EVEN
RECOGNITION OF WHAT'S OUT THERE
IN TERMS OF OTHER DATASETS AND I
WONDER IF THAT'S SOMETHING THERE
WOULD BE A MECHANISM FOR
IMPROVING IN THE FUTURE SO THAT
WHEN YOU HAVE A FINDING LIKE
PRIOR INFECTION INCREASES RISK
YOU CAN REVALIDATE WITH
NIH-GENERATED DATA RAPIDLY.
>> YEAH, THERE DEFINITELY IS.
THERE'S CONSORTIA BUILT AROUND
FOLKS, YOU KNOW, COHORTS,
NIH-FUNDED AND OTHERWISE, WITH
PROTEOMIC DATA INTERESTED IN
AGE-RELATED OUTCOMES.
THERE'S ONE FUNDED BY, WELL,
BEING SPONSORED BY VARIOUS
ORGANIZATIONS BUT REALLY POOL IN
DATA FROM NIH-FUNDED STUDIES,
AND THEY WILL SOMETIMES EMBARGO
FOR A YEAR AND OPEN TO THE REST
OF THE COMMUNITY AND THE ARAC
STUDY, TWO STUDIES WITH A
SIZEABLE RULEIN, WE CONTRIBUTED
DATA BUT OFTEN WE FIND THE
DIRECT INVESTIGATOR TO
INVESTIGATOR RELATIONSHIP,
TAPPING THOSE, ACROSS COHORTS IN
WEEKS.
SO IT IS ESPECIALLY WHEN WE'RE
ALL TALKING ABOUT THE SAME
PREDICTORS, IT CAN HAPPEN
QUICKLY.
JOURNALS REQUIRE IT ESSENTIALLY,
THIS REPLICATION.
>> THE SECOND QUESTION IS THE
SAME ON A DIFFERENT AXIS,
TALKING ABOUT NEURODEGENERATION,
ALMOST SYNONYMOUS WITH AGE
RELATED DEMENTIA, BUT THERE'S
AGE RELATED MACULAR DEGENERATION
AND GLAUCOMA, CAN SUBSTANTIAL
PUBLIC HEALTH MORBIDITY.
DO YOUR FINDINGS HOLD UP WITH
OTHER NEURODEGENERATIVE DISEASES
THAN NON-DEMENTIA?
>> I HAVEN'T LOOKED, TO BE
HONEST.
I THINK -- THE FIRST WE'VE GONE
BEYOND TRADITIONAL CONDITIONS IS
MULTIPLE SCLEROSIS, MY LAB
DOESN'T FOCUS ON ANYTHING BELOW
THE NECK WHEN IT COMES TO
OUTCOMES.
>> EYES ARE STILL ABOVE THE
NECK.
I THINK THERE'S A GREAT
OPPORTUNITY THERE BECAUSE THESE
ARE, AGAIN, DATASETS THAT ARE
SORT OF SHOVEL READY TO ASK THE
QUESTION OF WHETHER THE SAME
RISK FACTORS AND EVEN PROTEOMIC
PROFILES ARE PREDICTIVE OF OTHER
NEURODEGENERAL DISEASES.
MACULAR DEGENERATION IS A HIGHER
PREDICTOR OF DEVELOPING DEMENTIA
THAN APO 4 ALLELE, SO THERE MAY
BE AN OPPORTUNITY TO EXTEND YOUR
STUDIES INTO A BROADER GROUP OF
DISEASES.
>> RIGHT.
NO, THAT'S AN IMPORTANT POINT.
>> GREAT.
THANK YOU VERY MUCH FOR THOSE
QUESTIONS.
LUCILA, YOU'RE NEXT PLEASE.
>> JUST BRIEFLY, I THINK YOU
COULD EXPLORE THE "ALL OF US"
PROGRAM DATA AS WELL AS THE
VETERANS PROGRAM, VETERANS AGING
COHORT AS WELL AT LEAST ON
ASSOCIATION AND MOST NOTABLY
BECAUSE DIVERSITY OF THOSE
COHORTS IS, YOU KNOW, SEVERAL
TIMES MORE THAN FINLAND OR U.K.
BIOBANK COHORTS SO WOULD BE
INTERESTING TO SEE.
>> YEAH, MILLION VETERANS, WE'RE
MAKING INROADS THERE WITH
COLLABORATOR, PARTICULARLY WITH
RESPECT TO VACCINATION AND
EFFECT ON DEMENTIA RISK, SO THAT
IS SOMETHING WE'RE PURSUING,
IT'S A RICH RESOURCE.
I WOULD LOVE TO GET MORE OUT OF
"ALL OF US" FOR THE QUESTIONS WE
ARE TRYING TO ADDRESS.
AND I THINK A LOT OF IT, I THINK
MAYBE SPECIFIC FOR OTHER
DEMENTIA RESEARCHERS, IT COMES
DOWN TO THE OUTCOME.
LIKE ONES LIKE DEMENTIA, THE
PHENOTYPE IS WELL ESTABLISHED,
AND VALIDATED, WHETHER THROUGH
MEDICAL RECORDS OR SOME OTHER
ADJUDICATION.
PEOPLE WILL USE THE HECK OUT OF
IT.
BUT UNTIL THAT GETS ESTABLISHED,
THERE'S PAPERS ON IT, THAT AT
LEAST FOR ME IS WHAT'S HOLDING
UP OUR USE OF THAT COHORT,
ADJUDICATING OUTCOMES WE'RE MOST
INTERESTED IN.
>> WELL, THANK YOU SO MUCH, DR.
WALKER.
HEY, ALSO, INCIDENTALLY, THANK
YOU SO MUCH FOR MAKING SUCH A
GREAT CASE FOR ALL THE UPGRADES
AND NEW WORK AND INFRASTRUCTURE
WE REALLY WANT TO SEE AT THE
NATIONAL LIBRARY OF MEDICINE TO
ALLOW RESEARCHERS LIKE YOU AND
EVERYBODY ACCESS TO NOT ONLY
UNDERSTANDING THESE DATASETS
EXIST, YOU'RE OBVIOUSLY
KNOWLEDGEABLE IN THE FIELD BUT
WHAT ABOUT SOME OUTSTANDING
PERSON, NOT ONLY THAT DATASETS
EXIST BUT ESPECIALLY IN THE
CLINICAL CARE ENVIRONMENT, WE
HAVE THE PHENOTYPES
CHARACTERIZED CLINICALLY
MEANINGFUL COHORTS, YOU JUST
GAVE A GREAT EXAMPLE OF
SOMETHING WE'RE ALSO STRIVING
FOR.
THANK YOU SO MUCH.
I THINK NOW WE NEED TO MOVE ON.
CORRECT?
>> YEAH, JUST ABOUT ON TIME.
I SEE MARIE JOINED US.
>> GREAT.
DR. MARIE BERNARD IS GOING TO
GIVE A REPORT BACK TO YOU ON THE
ACD WORKING GROUP ON DIVERSITY.
>> GOOD AFTERNOON, EVERYONE.
HOPEFULLY YOU CAN SEE MY FIRST
SCREEN FOR COSWD UPDATE.
THIS IS WHAT WE TALKED ABOUT,
ADVISORY COMMITTEE TO THE
DIRECTOR WORKING GROUP ON
DIVERSITY MEETING YESTERDAY.
PEOPLE INDULGED ME WITH THE
OPPORTUNITY TO REVIEW WHAT WE'VE
DONE IN THE LAST FOUR YEARS
SINCE I HAVE BEEN THE COSWD.
WHAT WE TALKED ABOUT WAS RECENT
HISTORY.
I WAS PRIVILEGED TO BE ASKED TO
BE THE ACTING COSWD IN OCTOBER
2020.
I WAS SELECTED TO BE THE
PERMANENT COSWD AFTER NATIONAL
SEARCH IN MAY OF 2021.
SO WE'LL TALK ABOUT THAT.
WE'LL TALK ABOUT THE EVIDENCE
CASE FOR SCIENTIFIC WORKFORCE
DIVERSITY BECAUSE THAT'S WHAT
MOTIVATES EVERYTHING THAT WE DO.
AND THEN HOW YOU FOSTER
SCIENTIFIC WORKFORCE DIVERSITY,
IN PARTICULAR THE KEY BUILDING
BLOCKS OF OUR STRATEGIC PLAN,
BUILDING EVIDENCE, DISSEMINATING
IT, ACTING ON IT.
AND A BRIEF DISCUSSION ABOUT THE
WAY FORWARD.
SO AS I SAID, I WAS DEPUTY
DIRECTOR OF NATIONAL INTUT ON
AGING 2008 TO FALL OF 2020 ASKED
TO STEP IN AS ACTING COSWD.
DR. HANNAH VALANTINE DID A
BEAUTIFUL JOB DEVELOPING A
FOUNDATION FROM WHICH WE COULD
WORK.
WHEN IT CAME TIME FOR THE
NATIONAL SEARCH IN JANUARY I
SUBMITTED MY APPLICATION, I KNOW
A LOT OF GOOD PEOPLE APPLIED, I
WITH AS THRILLED TO HAVE BEEN
SELECTED.
WHAT I SAID IN MY APPLICATION
WAS THAT A GUIDING PRINCIPLE
WOULD BE THIS AFRICAN PROVERBS
IF YOU WANT TO GO FAST GO ALONE.
IF YOU WANT TO GO FAR, GO
TOGETHER.
I TALKED ABOUT THE FACT THE
MISSION OF THE COSWD OFFICE WAS
LIKE HAVING AN APPLE 50 TIMES
LARGER ON THE BACK OF AN ANT,
VERY FEW STAFF MEMBERS IN THE
OFFICE, YET THE GOAL IS TO MAKE
SURE THAT THIS BROAD
PARTICIPATION IN THE GENERATION
AND EXECUTION OF SCIENCE BECAUSE
OF THE DATA THAT I'LL BE SHOWING
SHORTLY THAT THAT PROMOTES
CREATIVITY AND INNOVATION.
I ALSO TALKED ABOUT THE FACT
THAT WE COULD CATALYZE THINGS,
WE COULD LEVERAGE THINGS.
BUT WE'RE PARTICULARLY
PRIVILEGED TO HAVE A LOT OF
ALLIES TO HELP CARRYING THAT
APPLE FORWARD.
WE WRITTEN ABOUT THIS IN --
>> MARIE, YOU'RE ON MUTE.
>> ACCIDENTALLY HIT MUTE, YES.
>> MARIE, YOU'RE ON MUTE.
>> HOPEFULLY NOW YOU CAN HEAR
ME.
>> YES.
>> OKAY.
SO WE'VE TALKED ABOUT THIS.
WE HAVE A NATURE MEDICINE
PUBLICATION FROM NOW THREE YEARS
AGO WITH LARRY TABAK, ALFRED
JOHNSON OUR DEPUTY DIRECTOR OF
MANAGEMENT, OUR THEN-DIRECTOR OF
OFFICE OF EQUITY DIVERSITY AND
INCLUSION TALKING ABOUT HOW
IMPORTANT IT IS TO GET DIVERSE
PERSPECTIVES AROUND THE TABLE TO
PROMOTE THE SCIENCE.
WE TALK ABOUT THE FACT THAT THE
SORTS OF PROBLEMS WE NEED TO
SOLVE IN BIOMEDICAL AND
BEHAVIORAL RESEARCH ARE LIKE
TRYING TO DESCRIBE AN ELEPHANT
SIGHTLESSLY.
THERE ARE HUGE PROBLEMS.
YOU NEED TO COME AT THEM WITH
DIFFERENT PERSPECTIVES.
WHAT INFORMS THOSE?
LOTS OF THINGS.
HOW YOU GREW UP, WHERE YOU GREW
UP, RURAL, URBAN, SES AS YOU
GREW UP, YOUR DISABILITY STATUS,
YOUR SEX, YOUR RACE, YOUR
ETHNICITY.
LOTS OF OTHER THINGS THAT MAKE
YOU THE UNIQUE PERSON THAT YOU
ARE AND BRINGING YOUR UNIQUE
PERSPECTIVE.
WE NEED A LOT OF UNIQUE
PERSPECTIVES AT THE TABLE TO GET
THE BEST SCIENCE.
IT'S NOT JUST A HYPOTHETICAL.
IT IS SOMETHING THAT'S BEEN
REALLY WELL DEMONSTRATED IN THE
BUSINESS LITERATURE AND IS A
BURGEONING LITERATURE IN
SCIENCE, ONE OF THE BEST
BUSINESS STUDIES TALKS ABOUT
TRADERS, HOMOGENUS VERSUS MIXED,
THE RETURN ON INVESTMENT IS
GREATER WITH THAT MIXED GROUP
BECAUSE YOU HAVE DIFFERENT
VIEWPOINTS.
FROM SCIENTIFIC PERSPECTIVE
THERE'S STUDIES LIKE CLASSIC
ARTICLE BY FREEMAN AND WANG FROM
2015 LOOKING AT 2.5 MILLION
ARTICLES IN THE LITERATURE TO
DETERMINE WHETHER A DIVERSE TEAM
VERSUS HOMOGENOUS TEAM LED TO
MORE IMPACTFUL PAPERS.
THEY LOOKED BASED UPON
GEOGRAPHIC LOCATION, HOW MUCH
INFORMATION WAS CITED, ETHNIC
BACKGROUND AS BEST ASSESSED
LOOKING AT LAST NAMES.
THERE'S AN ALGORITHM
COMPUTER-DRIVEN THAT MADE THAT
ASSESSMENT, NOT A PERFECT TOOL
BUT CONSISTENTLY APPLIED.
AND THEY FOUND THAT THE MORE
DIVERSE THE TEAM, YES, THE
HIGHER OF IMPACT FACTOR OF
JOURNAL IN WHICH THE PAPER IS
PUBLISHED AND MORE FREQUENTLY
THE PAPER IS CITED.
THERE'S A LOVELY STUDY IN 2020
HANES AND COLLEAGUES LOOKING AT
ORNITHOLOGY, WITH BIRD SONG.
THERE WAS A DOMINANT PARADIGM
BUT LOOKING CAREFULLY BASED UPON
MALE-DOMINATED FIELD, MALE
BIRDS.
AND FEMALES JOINED THE RANKS,
THEY LOOKED MORE WIDELY AT MALE
AND FEMALE BIRDS AND THAT
DOMINANT PARADIGM FELL.
REALLY SURPRISING EXAMPLE OF
BENEFITS OF DIVERSE
PERSPECTIVES.
THEN THERE'S A STUDY A COUPLE
YEARS AGO THAT LOOKED AT NOW
SOME 5 MILLION ARTICLES.
WHEN I TALK ABOUT DIVERSITY, I
TALK ABOUT THE FACT THAT IT'S
DISABILITY STATUS, GEOGRAPHY,
SES, THOSE THINGS ARE MORE
DIFFICULT TO MEASURE.
THE THINGS EASIER TO MEASURE,
THAT GET REPORTED THUS FAR,
THINGS LIKE SEX, RACE,
ETHNICITY.
SO IN THIS STUDY THEY LOOKED AT
WHO PUBLISHED WHAT BY SEX, RACE,
ETHNICITY.
AFRICAN AMERICAN MALE,
NON-HISPANIC WHITE MALE, ASIAN
MALES, LATINOS, ASIAN FEMALES,
LATINAS.
AFRICAN AMERICAN AND WHITE
FEMALES.
WHAT THEY FOUND WAS THAT THE
WOMEN TENDED TO PUBLISH MORE IN
THE ARTS AND HEALTH SCIENCES,
MUCH LESS IN ENGINEERING
TECHNOLOGY, PHYSICS.
ALMOST EXACT REVERSE FOR MEN.
THEY FOUND THE WOMEN PUBLISHED
LESS THAN THE MEN, WHICH IS A
KNOWN PHENOMENON BUT LED TO
CONCLUSION IF THERE WERE GREATER
PARITY IN PUBLISHING THERE WOULD
BE A DIFFERENT BODY OF
SCIENTIFIC KNOWLEDGE THAT WE
WOULD BE LOOKING AT.
AGAIN, SPEAKING TO THIS ISSUE OF
HAVING DIVERSE PERSPECTIVES AND
APPROACHES TO GET TO THE
GREATEST CREATIVITY AND
INNOVATION.
WE ADDRESSED THIS IN THE
SCIENTIFIC WORKFORCE DIVERSITY
SEMINAR THAT WE HAD IN MAY OF
2022.
WE STARTED DOING THESE IN
SEPTEMBER OF 21 TO ASK A
QUESTION EACH TIME.
THE QUESTION AT THAT MAY SEMINAR
IS HOW DOES DIVERSITY IMPACT
SCIENCE.
WE WERE REALLY HONORED TO HAVE
DR. ISLER, DOCTORS S
MITH-D.O.E.RR, JENNIFER KUAN,
SANTANGELO AND SHIRLEY TILGHMAN
GAVE CLOSING REMARKS, FOCUSING
ON THE MOST RECENT EVIDENCE.
I WOULD ENCOURAGE YOU TO GO TO
THE URLs LISTED THERE, ONE
PROVIDES PROCEEDINGS FROM THE
SEMINAR, AND THE OTHER IS THE
PROCEEDINGS ON THE NLM BOOKSHELF
WHICH CAN ALSO BE FOUND IN
PubMed.
BUT AGAIN LOOKING AT THE
EVIDENCE THAT IS WHAT'S
MOTIVATED THE THINGS WE'VE DONE
JANINE CLAYTON, AND OTHERS WROTE
ABOUT THIS IN NATURE
COMMUNICATIONS, WHAT IS THE
EVIDENCE, HOW DO YOU ACT ON
THIS?
IT'S CLEAR IF YOU'RE GOING TO
GET THAT BROAD PARTICIPATION,
DIVERSITY OF PERCEPTION AND
APPROACHES YOU HAVE TO BE
INCLUSIVE, HAVE INCLUSIVE
EXCELLENCE.
AND THERE'S NO ONE THING THAT
YOU CAN DO TO ACCOMPLISH THIS.
THERE ARE MULTIPLE THINGS.
WE DO NEED TO HAVE
DEMONSTRATABLE SUPPORT, FRANCIS
COLLINS, LARRY TABAK, MONICA
BERTAGNOLLI, I.C. DIRECTORS,
EVERYONE HAS BEEN ORIENTED TO
MAKING SURE WE HAVE A CULTURE OF
INCLUSION SO THAT EVERYONE
RECOGNIZES THEIR VALUE AND THE
THINGS THEY CAN CONTRIBUTE TO
MAKE FOR BETTER SCIENCE.
THAT'S GENERALIZABLE TO EVERYONE
IN THE COUNTRY.
ACTION ORIENTED ACCOUNTABILITY,
A NUMBER OF THINGS HAVE BEEN
GENERATED TO ALLOW FOR THAT.
SOME WE DIRECTLY GENERATED, SOME
WE'VE LEVERAGED AND CATALYZED.
WE NEED TO USE THE BEST
PRACTICES THAT ARE OUT THERE AND
WE'VE BEEN ABOUT THE BUSINESS OF
TRYING TO IDENTIFY THOSE BEST
PRACTICES AND DISSEMINATING
INFORMATION ABOUT THAT.
AND YET THIS WAS WRITTEN ABOUT
SUPPORTING WOMEN IN SCIENCE BUT
THIS ISSUE OF ENHANCED
FLEXIBILITY OPTIONS WE TALKED
ABOUT IN THIS ARTICLE ARE
APPLICABLE BROADLY FOR GROUPS OF
SCIENTISTS NOT WELL REPRESENTED
IN BIOMEDICAL AND BEHAVIORAL
RESEARCH.
MANY TIMES PEOPLE MAY COME FROM
SOCIOECONOMIC BACK GROUND WHERE
THEY DON'T HAVE THE FUNDS FOR
BROAD CHILD CARE OR OLDER ADULT
CARE OR HAVE LOTS OF OTHER
DEMANDS THAT ARE PLACED UPON
THEM AND THUS WILL NOT HAVE THAT
LINEAR PATH TO BECOME ALL ONE
FUNDED RESEARCHER AND WE NEED
FLEXIBILITY AND OPTIONS TO TAKE
ADVANTAGE OF THOSE TALENTS AS
WELL.
SO, AS I SAID, I WAS SELECTED
AFTER A COMPETITIVE PROCESS AS
THE COSWD MAY 31 OF 2021 AFTER
NINE MONTHS IN ACTING ROLE THUS
ABLE TO HIT THE GROUND RUNNING,
PUT OUT A STRATEGIC PLAN FOR 22
TO 26 BY MARCH OF 2022.
WE RECENTLY PUT OUT A MID-TERM
PROGRESS REPORT, WE'RE HALFWAY
THROUGH THAT TIME PERIOD.
WE TALKED WITHIN THAT STRATEGIC
PLAN ABOUT A VISION TO ENABLE
NIH AND NIH-FUNDED INSTITUTIONS
TO BENEFIT FROM THE NATION'S
FULL RANGE OF TALENT.
IF WE DON'T DO THAT WE'RE GOING
TO LOSE OUR LEADERSHIP ROLE
WORLDWIDE IN SCIENCE, FORCES
CREATIVITY AND INNOVATION, NOT
JUST FOR THE SAKE OF BEING GOOD
GUYS.
WE WANT TO HAVE THE BEST
SCIENCE.
OUR MISSION TO BE THE NIH
THOUGHT LEADER IN THE SCIENTIFIC
WORKFORCE DIFFUSING
EVIDENCE-BASED APPROACHES TO
CATALYZE CULTURES OF INCLUSIVE
EVIDENCE USING NIH AS A TEST
BED, DISSEMINATING EVIDENCE
ACROSS THE ECOSYSTEM AND ACTING
ON THE EVIDENCE.
HIGHLIGHTS, A FEW EXAMPLES,
PARTICULARLY IN TERMS OF
BUILDING EVIDENCE, WE WERE
PRIVILEGED TO LEAD THE SUBGROUP
ON INDIVIDUALS WITH
DISABILITIES, WHICH WAS A
SUBGROUP OF ADVISORY COMMITTEES
TO THE DIRECTOR OF DIVERSITY.
YOU'LL HEAR MORE ABOUT OUTCOMES
FROM THIS BUT AGAIN THIS ROLE OF
CATALYZING MY TEAM SPENT A SOLID
YEAR FOSTERING CONVERSATIONS
AMONG THIS SUBJECT MATTER EXPECT
GROUP, THIS WAS ON THE SUBJECT
GROUP HELPING TO CRAFT
SUGGESTIONS FOR NIH THAT WERE
TANGIBLE AND ACTIONABLE.
THAT LED TO A PRESENTATION TO
THE ACD NOW TWO YEARS AGO WHICH
GOT ADOPTED AS A SET OF
RECOMMENDATIONS, MULTIPLE
RECOMMENDATIONS, AS DR.
BERTAGNOLLI MENTIONED,
RECONSIDERATION OF THE NIH
MISSION, THAT PROCESS IS
ONGOING.
DR. SCHWETZ ELABORATED UPON.
THERE'S A RECOMMENDATION
DISABLED POPULATIONS BE NAMED A
HEALTH DISPARITIES POPULATION.
THAT FOLLOWING AUGUST THE
DIRECTORS WHO COULD DECLARE
HEALTH DISPARITY POPULATIONS DID
SO FOR DISABLED POPULATIONS.
THERE WAS NOT SPECIFIC
RECOMMENDATION BUT THIS NEEDED
TO BE SYNERGIZED WITH THE
STRATEGIC PLAN IN MARCH OF 2023
AND IS ONGOING.
IT WAS CLEAR CERTAINLY TO ME
LISTENING TO THE DISCUSSIONS OF
THIS SUBJECT MATTER EXPERT GROUP
THAT WE NEEDED TO HAVE AN
ASSESSMENT OF THE NIH
DISABILITIES RESEARCH PORTFOLIO.
I'M GRATEFUL THAT THE DIVISIONAL
PROGRAM COORDINATION AND
RESEARCH AND STRATEGIC PLANNING
OR DPCPSI IS IN THE PROCESS OF
DOING EXACTLY THAT.
WE ARE STARTED ON BUILDING
SOMETHING WE CALL ENGAGEMENT AND
ACCESS FOR RESEARCH ACTIVE
INSTITUTIONS, THIS CAME FROM NIH
INITIATIVE RECOGNIZED THAT THERE
ARE SCIENTISTS OFTEN FROM GROUPS
NOT WELL REPRESENTED IN
BIOMEDICAL AND BEHAVIORAL
RESEARCH WHO GOT THEIR INITIAL
TRAINING AT INSTITUTIONS THAT
ARE DEFINED AS RESEARCH ACTIVE
INSTITUTIONS.
INSTITUTIONS THAT AWARD DEGREES
IN THE HEALTH PROFESSIONS OR
SCIENCE RELATED TO HEALTH AND
STEM FIELDS BUT DO NOT ENJOY
MUCH IN THE WAY OF NIH FUNDING.
WE'RE SAYING NO MORE THAN $25
MILLION PER YEAR AVERAGE COST OF
NIH RESEARCH PROJECT GRANT
FUNDING.
THE ISSUE WAS HAD THERE BEEN
MORE AS THEY GOT STARTED THAT
THEIR CAREER MIGHT HAVE BEEN
ACCELERATED, AND FOR COLLEAGUES
WHO DID NOT END UP PERSEVERING
WHO WENT INTO OTHER FIELDS THEY
MIGHT HAVE BEEN MORE INSPIRED
HAD THERE BEEN MORE IN THE WAY
OF NIH FUNDING.
SO WE, THE COSWD TEAM, AFTER A
LOT OF DELIBERATIONS INTERNALLY
TOOK THIS ON ON BEHALF OF NIH TO
BE RESPONSIVE TO FEEDBACK THAT
THESE INSTITUTIONS FOUND THIS
VERY DIFFICULT TO ACCESS,
SYSTEMS WERE COME LATED, I'VE
HEARD THE TERM "ARCANE,"
DIFFICULT TO TALK TO ANYONE,
PROGRAM OFFICER IS HARD TO
REACH, MUCH LESS NIH LEADERSHIP.
WE'VE BEEN WORKING A GOOD YEAR,
MORE THAN A NOW, ANNOUNCED IN
OCTOBER OF 2023 I BELIEVE IT
WAS, THIS INITIATIVE, ADVISORY
COMMITTEE WORKING GROUP FOR
LEADERSHIP AND MEMBERS OF CENTER
FOR SCIENTIFIC REVIEW, MINORITY
HEALTH, OFFICE OF ACQUISITION
AND LOGISTICS MANAGEMENT AND
EXTRAMURAL RESEARCH, REALLY ALL
OF THE NIH INSTITUTES AND
CENTERS HAD BEEN SUPPORTING THIS
INITIATIVE FOR US.
THE INTENT IS TO BECOME A
ONE-STOP SHOP FOR LEADERSHIP AND
FACULTY AT THESE INSTITUTIONS
WHERE IT'S EASY TO NAVIGATE WHAT
IS AVAILABLE AT NIH AND TO
IDENTIFY WHAT IS MOST
APPROPRIATE FOR THEM.
SO WE HAVE A WEBSITE THAT'S
EVOLVING, A NEWSLETTER THAT
PROVIDES INFORMATION ABOUT
RESEARCH GRANT PROCESSES, NOTICE
OF FUNDING OPPORTUNITY, ET
CETERA.
HERE IS A SCREEN SHOT OF THE
WEBSITE.
AND A QR CODE TO GET THERE, EVER
EVOLVING.
IT'S MEANT TO BE THAT EASY PLACE
FOR ACCESS.
WE ALSO HAVE A NEWSLETTER, FIRST
NEWSLETTER OUT IN JULY.
I'LL SAY WE'VE LEARNED THAT
BEAUTIFUL LONG NEWSLETTERS SUCH
AS WE SENT OUT ARE NOT
NECESSARILY HELPFUL TO THE
FACULTY, THE TARGET HERE.
WE'RE NOW DOING A NEWS BLAST
SECOND AND AND FOURTH TUESDAY F
EACH MONTH.
WE HAVE ANOTHER COMPONENT.
WE WEREN'T CERTAIN IF WE BUILT
IT THEY WOULD COME SO THE INTENT
HERE WAS TO ENGAGE WITH
INSTITUTIONS THAT MEET OUR
DEFINITIONS OF RAI TO BETTER
UNDERSTAND AND BETTER CONNECT
THEIR FACULTY WITH RESOURCES.
WE STARTED OFF WITH THOSE
INSTITUTIONS THAT HAVE HAD SOME
FUNDING BUT NOT MORE THAN THAT
$25 MILLION AVERAGE RPG GRANT
FUNDING FOR PRIOR THREE YEARS.
GOING THROUGH A PROCESS OF
TRYING TO IDENTIFY ELIGIBLE
INSTITUTIONS WE IDENTIFIED ABOUT
115 OR SO, WROTE TO THE
PRESIDENT AND SENIOR VICE
PRESIDENT FOR RESEARCH AT THOSE
INSTITUTIONS, WOULD YOU LIKE TO
ENGAGE?
OUR THOUGHT WAS WE WOULD
PROBABLY GET 20 INSTITUTIONS TO
VOLUNTEER AND WOULD WORK
INTENSIVELY WITH 12.
WE GOT 50+ REALLY ENTHUSIASTIC
VOLUNTEERS.
AND DECIDED THAT WE WILL WORK
WITH ALL OF THEM BECAUSE THERE
WAS SUCH ENTHUSIASM THERE.
THE VOLUNTEER INSTITUTIONS ARE
FROM RURAL, IDeAS, HISTORICAL
BLACK COLLEGES AND OTHER
MINORITY-SERVING INSTITUTIONS,
KEEPS WITH THE CHIPS IN SCIENCE
ACT, NOT MORE THAN $25 MILLION
AVERAGE IN FUNDING.
OTHER INSTITUTIONS MAY NOT HAVE
HAD ANY NIH FUNDINGS TO WHOM WE
NEED TO MAKE OUTREACH.
WE'RE STARTING SMALL TO FIGURE
OUT HOW TO GENERALIZE BEYOND
THAT.
WHAT WE'RE DOING IN THIS
ENGAGEMENT IS FOCUSING ON THIS
PORTION OF THE GRANT LIFE CYCLE.
THERE'S A LOT TO GETTING A GRANT
SUBMITTED AND FUNDED.
YOU HAVE TO CONCEIVE OF THE
NOTION, FIND YOUR COLLABORATORS,
DEVELOP YOUR ABSTRACT AND AIMS.
THE PART WE'RE FOCUSING ON ONCE
THAT ABSTRACT AND AIMS DOCUMENT
IS DEVELOPED, GETTING THE
FACULTY MEMBER APPROPRIATELY
MATCHED TO INSTITUTE OR CENTER
AND HAVE A CONVERSATION WITH THE
PROGRAM OFFICER WHOSE PORTFOLIO
MIGHT OVERLAP WITH TO HAVE A
CONVERSATION.
PEOPLE CAN READ WHATEVER THEY
WANT INTO IT SO HAVING THAT
CONVERSATION IS REALLY
IMPORTANT.
AND HAVING CONVERSATION ABOUT
SCIENTIFIC REVIEW GROUP, OTHER
I.C.s, SOMETIMES ONE MAY HAVE
A MORE GENEROUS FUNDING LINE
THAN ANOTHER.
WE'RE NOT LOOKING AT APPLICATION
FOLLOW-UP FEEDBACK OR
RESUBMISSION, JUST THIS PART OF
IT, WHICH CAN BE REALLY PIVOTAL
TO THE SUCCESS OF RESEARCHER.
WE AS I SAID ARE MAKING OUTREACH
TO BE MORE PRECISE 52
INTUITIONS.
WE MET WITH THE PRESIDENT AND
RESEARCHERS THIS PAST SPRING,
DOING ANOTHER 15 INSTITUTIONS
NOW, FINISHED A MEETING WITH THE
INSTITUTIONS USUALLY AN HOUR AND
15 MINUTES PERIOD OF TIME AND
WE'RE GOING THROUGH THE PROCESS
OF MATCHING THEM WITH I.C. AND
PROGRAM OFFICER AND DOING A WARM
HANDOFF, E-MAIL INTRODUCTION,
FACULTY MEMBER, PROGRAM OFFICER.
THE GOAL TO DO REMAINING
INSTITUTIONS THIS SPRING,
APPROXIMATELY FEBRUARY TO JULY.
WE STARTED OFF BASED ON
GEOGRAPHY, DIVERSITY, WE FOUND
THAT THERE'S SQUISHINESS, SOME
WAVE 1 BECAME WAVE 2, SOME 2
MOVE TO 3, ALL SORTS OF THINGS
HAPPENED BUT WE WORK WITH THEM.
THESE ARE THE INSTITUTIONS
INVOLVED WITH WAVE 1.
THIS INCLUDES SIX HISTORICALLY
BLACK COLLEGES AND UNIVERSITIES,
FOUR RURAL INSTITUTIONS IN
IDeA STATES.
AND THIS IS THE OUTCOME OF MAT.
OUR TEAM MATCHED THEM TO AN
INSTITUTE OR CENTER AND A
PROGRAM OFFICER.
WE DID A PRETTY GOOD JOB OF
MATCHING, 75% OF THE TIME TO SAY
IS THIS APPROPRIATE MATCH THEY
AGREED.
BUT WE DIDN'T DO AS WELL IN
MATCHING TO THE PROGRAM OFFICER
IN ONLY 58% OF THE TIME WAS THAT
AN APPROPRIATE MATCH, FROM THE
VIEWPOINT OF LEADERSHIP.
SOMETIMES PROGRAM OFFICERS HAD
CHANGED PORTFOLIOS, LEAVE, ALL
SORTS OF THINGS.
ANOTHER FACT WE THOUGHT PERHAPS
THAT THE SCIENTISTS KNOW THEIR
SCIENCE BETTER THAN WE DO AND
MAYBE THEY NEED TO BE DOING THE
MATCHING SO THAT'S SOMETHING
THAT'S BEEN CHANGED TO WAVE 2
THAT WE'RE HAVING THE FACULTY DO
THE INITIAL MATCHING RATHER THAN
OUR TEAM TO SEE WHETHER THAT PO
MATCH TURNS OUT TO BE BETTER.
WAVE 1 THE INTENT WAS TO MAKE
SURE THE FACULTY HAD MORE THAN
ONE CONNECTION TO AN I.C.
BECAUSE, AGAIN, SOMETIMES IT'S
AMAZING HOW MANY I.C.s HAVE
SIMILAR INTERESTS AND HOW
DIFFERENT THE OPPORTUNITIES FOR
FUNDING MIGHT BE FOR I.C.s.
AND WE WERE VERY PLEASED THAT AT
LEAST 65% OF THE FACULTY WERE
ABLE TO HAVE TWO OR MORE
CONNECTIONS.
WHAT DID WE LEARN?
WE LEARNED THESE INSTITUTIONS
ALL HAD UNIQUE STRENGTHS TO BE
LEVERAGED FOR POTENTIAL GRANT
APPLICATIONS, NSF FUNDING,
DoD, DEPARTMENT OF
AGRICULTURE, SOME INFRASTRUCTURE
FUNDING FROM NIH, SOME HAD
PHILANTHROPIC SUPPORT FOR THEIR
OFFICE OF SCIENCE SPONSORED
RESEARCH BUT ALL THAT STRENGTHS,
WHICH IS WONDERFUL AND THEY
BRING DIFFERENT PERSPECTIVES TO
THE SCIENCE OF NIH.
BECAUSE WE WERE LOOKING FOR
PEOPLE WHO HAD AN ABSTRACT
SPECIFIC AIM, FAIRLY
SOPHISTICATED, PRETTY UNIFORMLY
TURNED IN ABSTRACTS REALLY WELL
WRITTEN.
AND NOT EVEN A HANDFUL SUBMITTED
ABSTRACTS AND AIMS BUT HAD A
CONVERSATION WITH SOMEONE FROM
THE I.C. TO GET A BETTER
UNDERSTANDING HOW TO GO FORWARD.
UNLESS FACULTY WERE BEYOND EARLY
CAREER STAGE.
WHAT WE LEARNED AT END OF WAVE
1, CONVENING IN AUGUST, WHAT
COULD BE DONE BETTER, GIVING
THEM A CHANCE TO HAVE INTERNAL
NETWORKING AND NETWORK WITH OUR
NIH STAFF WHO WERE INVOLVED WITH
THE ADVISORY COMMITTEE, THEY
WERE REALLY GRATEFUL FOR THE
CONNECTIONS WITH THE PROGRAM
OFFICER.
SOME NOT REALIZING YOU COULD
MAKE SUCH OUTREACH.
AND THEY -- IN THE MAJORITY OF
CASES FOUND THE PROGRAM OFFICER
WAS HELPFUL, 73 OUT OF 74.
THERE'S ALWAYS A CURMUDGEON IN
THE GROUP BUT THAT'S OKAY.
WE HEARD THESE FOLKS ARE REALLY
BUSY, MANY WITH HEAVY TEACHING
LOADS, ET CETERA, THEREFORE THEY
APPRECIATE INFORMATION PACKAGED
AND DELIVERED TO THEM.
THAT LED TO EARA NEWS BLAST.
THESE ARE INSTITUTIONS INVOLVED
IN WAVE 2, INCLUDING THREE
HBCUs.
WE'RE IN THE MIDDLE OF THE
PROCESS.
WE'VE MET WITH ALL, HAVE GOTTEN
ABSTRACT OF AIMS FROM THE
FACULTY NOW, CONFIRMING WITH THE
LEADERSHIP OF I.C.s THE
MATCHES ARE APPROPRIATE.
IN THIS CASE WE TAUGHT THEM TO
DO THEIR OWN MATCHES, I'LL
ELABORATE IN JUST A MOMENT.
WE SENT IT TO I.C. LEADERSHIP.
THIS IS DIFFERENT.
IN PURPLE YOU SEE WE HAVE THE
INITIAL CALL AND TRAIN THEM
DURING THAT CALL TO USE THE NIH
TOOL MATCHMAKER.
IT'S A GREAT TOOL FOR TRYING TO
FIGURE OUT WHAT I.C., WHAT
PROGRAM OFFICER, WHAT GROUP,
HELP THEM TO BE REALLY ADEPT AT
USING IT WAS THE INTENT HERE.
THEY THEN WERE SENT OUT TO
IDENTIFY THEIR OWN MATCHES TO
SUBMIT THAT INFORMATION TO US
WITHIN A COUPLE WEEKS.
WE HAVE TEAM MEMBERS AVAILABLE
TO PROVIDE THEM TECHNICAL
ASSISTANCE.
AND THEN THERE WAS A FOLLOW-UP
E-MAIL THAT WENT TO I.C.
LEADERSHIP TO ASK DOES THIS
APPEAR TO BE APPROPRIATE, THEN
THERE WAS E-MAIL CONNECTION DONE
BETWEEN THE FACULTY MEMBER AND
THE PROGRAM OFFICER AFTER WE HAD
CONFIRMATION THAT THE CONNECTION
WAS APPROPRIATE.
TEAM DID A COUPLE FOLLOW-UPS,
THEY WILL BE DOING A COUPLE
FOLLOW-UPS AS THEY DID WITH WAVE
1 TO MAKE SURE ANY PROBLEMS THAT
MAY HAVE OCCURRED WE'VE MADE
SOME INTERVENTIONS, AND THERE
WILL BE ANOTHER VIRTUAL
CONVENING EARLY MARCH TO SEE HOW
THINGS WENT FOR WAVE 2 FACULTY
AND TO GIVE THEM A CHANCE TO
NETWORK AMONG THEM SELVES AND
NIH STAFF WITH THE IDEA WHATEVER
LESSONS LEARNED FROM THAT BEING
APPLICABLE TO THE WAVE 3 FOLKS.
AND AFTER ALL THREE PRESUMABLY
I'LL BE RETIRED BUT PRESUMABLY A
CHANCE TO STEP BACK AND SEE WHAT
ARE GENERALIZABLE PRINCIPLES
FROM THAT CAN BE USED WITH
OTHERS.
THIS IS A MAP THAT SHOWS THE
LOCATION OF ALL THE TARGETED
INSTITUTIONS, SPRING OF 2024 IS
WAVE 1 INSTITUTIONS, WINTER 2025
WAVE 2 INSTITUTIONS, SUMMER 2025
WAVE THREE.
THINGS MOVE AROUND.
UNTIL IT'S ABSOLUTELY CONFIRMED
WHAT THE WAVE 3 INSTITUTIONS ARE
THAT IS NOT SHARED.
THAT'S BEEN A BIG EFFORT,
BUILDING THAT IS GOING TO GROW
AND EXPAND.
BECAUSE IT'S REALLY IMPORTANT
TO, AGAIN, BRING IN DIFFERENT
PERSPECTIVES AND NOT THE USUAL
SUSPECTS ADDRESSING QUESTIONS OF
BIOMEDICAL AND BEHAVIORAL
RESEARCH.
WE WORK ON DISSEMINATING
EVIDENCE.
WE'VE HAD BLOGS.
WE HAVE SCIENTIFIC DIVERSITY
WORKFORCE SEMINAR SERIES.
I'D LIKE TO POINT OUT THAT,
AGAIN, SEMINAR SERIES
INFORMATION IS ON NLM BOOKSHELF.
IT CAN BE SEARCHED BY
PubMed.
IT BRINGS TOGETHER RELATED
EVIDENCE FROM EACH ONE OF THESE
SEMINARS, A TOTAL OF 12 OR 15 OF
THEM, WITH LOTS OF REFERENCES.
WE'RE HONORED TO HELP CO-LEAD
THE DEVELOPMENT OF THE NIH-WIDE
DEIA STRATEGIC PLAN.
THIS IS SOMETHING A MANDATE OF
THE BIDEN ADMINISTRATION,
EXECUTIVE ORDER, HOWEVER WAS
DEVELOPED TWO DIFFERENT
MANDATES, NOT ONLY EXECUTIVE
ORDER BUT ALSO LANGUAGE FROM THE
FISCAL YEAR 21 21 NIH BUDGET TO
ASSURE A DIVERSITY OF RESEARCH
WITH NIH-FUNDED RESEARCH SO YOU
SEE PARTICULARLY IN OBJECTIVE 3
OF THIS PLAN ATTENTION TO THAT
ISSUE.
WE'RE REALLY GRATEFUL TO ALL
100+ NIHers WHO CONTRIBUTED TO
THE DEVELOPMENT OF PLAN AND
COLLEAGUES AT EDI LEADING
IMPLEMENTATION OF IT.
WHAT DOES THE FUTURE HOLD?
AS OF DECEMBER 31 I WILL BE
RETIRED.
WATCHING FROM A DISTANCE.
BUT I THINK THAT THERE WILL BE
AN OPPORTUNITY GOING FORWARD TO
MORE BROADLY APPLICABLE
EVIDENCE-BASED INITIATIVES.
WHAT HAS BEEN DEVELOPED HAS BEEN
BROADLY APPLICABLE.
WE DON'T TARGET A PARTICULAR
TYPE OF INDIVIDUAL.
WE THINK OF THINGS BROADLY.
WELL, OKAY, WE'RE TARGETING WITH
THE RAI INITIATIVE INSTITUTIONS
THAT HAVE NOT HAD MUCH IN THE
WAY OF NIH FUNDING.
BUT INITIATIVES ARE BROADLY
APPLICABLE.
A RISING TIDE LIFTS ALL BOATS IS
APROPO.
I'LL CLOSE BY SAYING WHAT I SAID
WHEN I APPLIED FOR THE JOB.
IF YOU WANT TO GO FAST, GO
ALONE.
IF YOU WANT TO GO FAR, YOU GO
TOGETHER.
WE'VE BEEN ABLE TO GO REALLY FAR
THANKS TO THE SUPPORT OF MANY,
MANY, MANY INDIVIDUALS.
I WOULD LIKE TO PARTICULARLY
THANK MONICA BERTAGNOLLI AND
LARRY TABAK WHO HAVE BEEN
STEADFAST IN THEIR SUPPORT.
ALL OF I.C. DIRECTORS, ADVISORY
COMMITTEE, CHAIR AND WORKING
GROUP ON DIVERSITY, INTERNAL
GROUPS WORKING WITH US TO MOVE
THINGS FORWARD.
ALL I CAN SAY IS MANY THANKS TO
ALL.
IT'S BEEN A REALLY WONDERFUL
FOUR YEARS.
THANK YOU.
>> WOW, THANK YOU SO MUCH,
MARIE.
LET ME JUST SAY THANK YOU FOR
ALL YOU'VE DONE TO ELEVATE OUR
SCIENTIFIC EXCELLENCE ACROSS THE
BOARD TO EMPOWER A WORKFORCE WE
REALLY NEED TO SEE AND TO REALLY
MAKE IT POSSIBLE FOR SO MANY
MORE PEOPLE THAT HAVE SO MUCH TO
CONTRIBUTE TO PARTICIPATE IN OUR
IMPORTANT WORK.
THIS IS OPEN FOR QUESTIONS FROM
THE TEAM.
WE HAVE ABOUT 15 MINUTES.
>> ANY COMMENTS OR QUESTIONS
FROM FOLKS?
>> MY ONLY COMMENT IS WOW, WHAT
A TOUR DE FORCE THROUGH AN
EVIDENCE-BASED A APPROACH.
THANK YOU FOR THE YEARS OF
SERVICE, YOUR LEADERSHIP THROUGH
NIA, NOW IN THIS WORK AROUND
WORKFORCE DIVERSITY.
THANK YOU AND APPRECIATE YOU.
VERY LARGE SHOES TO FILL.
>> THANK YOU SO MUCH.
>> OTHER COMMENTS OR QUESTIONS
THAT PEOPLE MAY HAVE?
YES, RUSS?
>> DR. BERNARD, LET ME ALSO
ECHO DEEP APPRECIATION.
I'VE WATCHED YOUR WORK ON
COUNCIL OF COUNCILS AS WELL.
CLEARLY YOUR IMPACT ON NIH AS A
WHOLE IN THE SCIENTIFIC
ESTABLISHMENT IS PROFOUND.
THE QUESTIONS, WHAT ADVICE ARE
YOU GOING TO GIVE YOUR
SUCCESSOR?
WHAT IS THE BIGGEST TASK YOU SEE
BEFORE YOU RIGHT NOW AS WE MOVE
INTO THE POST-ERA OF YOUR
LEADERSHIP?
>> GOOD QUESTION.
WHAT I SEE IS A LOT OF DIFFERENT
PEOPLE BEING INVOLVED AND
RESPONSIBLE FOR MAKING SURE THAT
THERE'S BROAD PARTICIPATION IN
SCIENCE.
AND WHAT I WOULD SAY TO EVERY
ONE OF THEM IS THAT THEY SHOULD
BE VERY, VERY PROUD OF THE WORK
THEY ARE DOING.
AND THE FACT THAT THEY HAD THE
CHANCE TO DO IT HERE AT NIH, YOU
KNOW, BEST PLACE IN THE WORLD TO
GENERATE KNOWLEDGE AND SCIENCE.
AND DR. BERTAGNOLLI KEEPS
SAYING, INTENT IS FOR WHAT WE
DEVELOP TO BE APPLICABLE TO ALL.
SO THEIR JOB IS TO MAKE SURE
THAT HAPPENS.
AND THAT BEGINNINGS WITH MAKING
SURE YOU HAVE THE BEST IN THE
WAY OF IDEATION, THAT'S BROAD
PARTICIPATION.
KEEP UP THE GOOD WORK.
KEEP DOING WHAT YOU'RE DOING IN
TERMS OF MAKING SURE THAT YOU'RE
THINKING DIFFERENTLY AND THAT
YOU'RE LISTENING TO SOMETHING
THAT YOU DIDN'T THINK ABOUT.
YOU KNOW, THE STUDY OF
ORNITHOLOGY WHERE THEY HAD MORE
WOMEN COME IN, SUBVERTED
DOMINANT PARADIGM.
SOMETIMES YOU PERSON WHO BRINGS
SOMETHING FORWARD YOU DIDN'T
EXPECT THAT'S THE PERSON THAT
COMES UP WITH THE ANSWER BUT
THAT CAN SOMETIMES BE THE CASE.
TO REMEMBER THAT, TO REMEMBER
THE MISSION THAT WE HAVE AT NIH,
KEEP WORKING TOWARDS THAT IS
WHAT I WOULD ENCOURAGE ALL OF
THE FOLKS WHO HAVE BEEN
INVOLVED, NOT JUST ONE.
>> THANK YOU.
OTHER COMMENTS?
YES, GO AHEAD.
>> I WANT TO SAY I THINK THIS IS
A REALLY IMPORTANT AREA AND I
THINK THAT AT THIS TIME RECENTLY
WE'VE SEEN DIFFERENT
UNIVERSITIES, DIFFERENT
PROGRAMS, GETTING RID OF THEIR
DIVERSITY INITIATIVES AND I WANT
TO SAY IT'S INCREDIBLY IMPORTANT
THAT WE KEEP MOVING THIS NEEDLE
FORWARD.
IT'S A SLOW PROCESS.
I JUST GRADUATED MY FIRST
STUDENT, MY FIRST UNDERGRADUATE
JUST GRADUATED WITH A DOCTORAL
DISSERTATION YESTERDAY SO 17
YEARS LATER, SO IT TAKES A WHILE
TO BUILD THESE FOLKS.
IT'S A LOT OF EFFORT.
WE HAVE TO BE PERSISTENT WE
DON'T LOSE ANY MOMENTUM THERE.
ONE OF THE THINGS I WAS GOING TO
SUGGEST AND THEN YOU WENT RIGHT
INTO IT WAS IMPORTANCE OF
COMMUNICATING WHAT THE EFFECT OF
DIVERSITY IS.
WHAT THE MEANING IS BEYOND
SIMPLIFYING, YOU KNOW, AMERICANS
HAVE A TENDENCY TO SIMPLIFY,
IT'S NOT.
DIVERSITY OF IDEAS, DIVERSITY OF
OPPORTUNITY, OPPORTUNITY IS THE
ONE KEY TO GETTING PEOPLE --
GETTING DIFFERENT AGENCIES
DIVERSE.
WE HAVE TO CREATE AS MANY
OPPORTUNITIES AS WE CAN.
I APPRECIATE YOUR WORK DOING
THAT.
SO, THANK YOU FOR THAT.
I REALLY APPRECIATE IT.
>> I'M EXCITED ABOUT THE THE WK
CONTINUING WITH THE EARA
INITIATIVES.
THAT'S GOING TO BE REALLY
IMPORTANT TO MAKING SURE DIVERSE
VOICES ARE THERE.
I GREW UP IN OKLAHOMA.
I SPENT SOME TIME AS A FACULTY
MEMBER AT UNIVERSITY OF OKLAHOMA
COLLEGE OF MEDICINE.
AND THERE'S SUCH GREAT -- WE HAD
SUCH BRIGHT STUDENTS THERE AT
UNIVERSITY OF OKLAHOMA COLLEGE
OF MEDICINE.
AND I THINK WE NEED CAPTURE THAT
TALENT.
IT'S ALL OVER THE COUNTRY.
WE DON'T NECESSARILY MAKE AS
MUCH CONTACT AS WE NEED IN THOSE
SETTINGS.
>> AS MARIE KNOWS, I'M A PROUD
GRADUATE OF CITY COLLEGE OF NEW
YORK.
SO, YOU KNOW, IT CAN HAPPEN.
YOU CAN GO TO PLACES THAT AT
LEAST AT THE TIME WERE A BIT
UNDERRESOURCED RELATIVE TO THEIR
NEIGHBORING INSTITUTIONS, OF
WHICH THERE ARE MANY.
BUT, YOU KNOW, I THINK THE EARA
PROGRAM IS INCREDIBLY IMPORTANT.
AND THE OUTREACH, YOU KNOW, THAT
I'VE HAD THE PRIVILEGE OF DOING,
TRAVELING AROUND THE COUNTRY,
BECAUSE I DO TEND TO GO TO
SCHOOLS THAT ARE A BIT MORE
UNDERRESOURCED THAN OTHERS, I
ALWAYS FIND AMAZING PEOPLE TO
INTERACT WITH.
AND JUST SOMETIMES IT JUST
REQUIRES A BIT OF ENCOURAGEMENT
BECAUSE UNFORTUNATELY, YOU KNOW,
THE SYSTEM CAN BE DAUNTING IF
YOU DON'T HAVE FOLKS AT YOUR
INSTITUTION WHO HAVE
SUCCESSFULLY NAVIGATED IT.
AND I THINK THE EARA PROGRAM IS
GOING TO FILL AND IS BEGINNING
TO ALREADY FILL THAT GAP, THAT
VOID, AND SO WE'RE REALLY JUST
DELIGHTED AT THE UPTAKE OF THAT
PROGRAM AND OUR HOPE IS TO
CONTINUE THIS AND EXPAND UPON
IT.
YOU KNOW, MARIE OUTLINED HOW
THAT COULD HAPPEN.
OTHER COMMENTS OR QUESTIONS?
>> I CAN ADD A QUICK ONE.
AND THAT IS, YOU KNOW, DEIA, THE
ACCESSIBILITY PART TOO IS, YOU
KNOW, SOMETHING THAT I THINK
MARIE IS ALSO CHAMPIONING SO
MUCH.
ABOUT BRINGING THE BEST MINDS.
WE LIVE IN A WORLD WITH A LOT OF
TECHNOLOGY, A LOT OF POTENTIAL
TO OPEN DOORS TO PEOPLE, TO
THESE BRILLIANT MINDS WE WANT TO
ENGAGE IN WAYS WE HAVEN'T HAD
BEFORE.
I REALLY THINK AT APPLYING THAT
NOT ONLY TO AS OUR RESEARCH AIM
TO IMPROVE PEOPLE'S LIVES,
ALLOWING THEM TO LEAVE FULLER
AND MORE ACTIVE LIVES, IT'S
SOMETHING WE ASPIRE TO FOR
IMPROVING PEOPLE'S ABILITY TO
CONTRIBUTE TO BIOMEDICAL
RESEARCH.
AND THAT ONE IS ALSO GOING TO BE
REALLY STRONG GOING FORWARD.
OKAY.
LAST CALL.
IF THAT'S WE'LL TAKE A COFFEE
BREAK I THINK.
>> OH, GO AHEAD.
>> I'LL EXPRESS MY SENTIMENTS,
DR. BERNARD.
I'D LIKE TO EXPAND TO THE GROUP
HERE.
I'M VERY THANKFUL FOR THE WORK
YOU'VE DONE, DR. BERNARD.
TWO ISSUES ARE CLOSE AND DEAR TO
ME PERSONALLY.
AS A PROFESSIONALS IN TERMS OF
ENSURING INCLUSION AS RELATES TO
RESEARCH, ACTIVE INSTITUTIONS,
MINORITY SEARCHING INSTITUTIONS
SUCH AS HBCUs, OF COURSE A
STALWART IN TERMS OF PUSHING AN
AGENDA FOR -- FORWARD FOR PEOPE
WITH DISABILITIES, SCIENTIFIC
WORKFORCE, CONTRIBUTING TO A
BROADER SCIENTIFIC WORK FORCE
AND ACTIVATION OF A VULNERABLE
POPULATION AND PERSONS WITH
DISABILITY NOT IDENTIFIED AS A
HEALTH DISPARITY GROUP
POPULATION WITHIN NIH AND OF
COURSE THIS IS A PARADIGM SHIFT
IN TERMS OF A POPULATION THAT
NIH TARGET, IN TERMS OF
IMPROVING SELF-CARE FOR THOSE
INDIVIDUALS.
SO I WANT TO THANK YOU AGAIN FOR
ALL THAT YOU'VE DONE FOR THE
FIELD, BIOMEDICAL AND BEHAVIORAL
FIELDS, AND FOR THE SCIENTISTS
IN THE FIELD, PARTICULARLY THOSE
WITH DISABILITIES.
WE WISH YOU A RESTFUL
RETIREMENT, I'M SURE YOUR LEGACY
WILL BE EXTENDED FORWARD FOR
YEARS TO COME.
>> THANK YOU SO MUCH.
>> HEAR, HEAR.
THANK YOU, COREY.
>> ONE LAST STATEMENT EVERY
OPPORTUNITY THAT YOU HAVE AT NIH
TO OPEN YOUR DOORS AND BRING
YOUNG PEOPLE IN FROM ZERO TO
WHATEVER, EVEN AN AFTERNOON, A
DAY, THE STUDENT I WAS JUST
SPEAKING ABOUT DID A FELLOWSHIP
AT NIH.
A LONG-TERM FELLOWSHIP.
I HAVE A LIST OF FOLKS WHO HAVE
DONE A PROGRAM, EVEN A ONE-WEEK
SUMMER SEMINAR THERE.
IT MAKES SUCH A HUGE IMPACT ON
THEM.
I THINK IT'S REALLY IMPORTANT.
AND THEY END UP IN PLACES, LABS
THEY NEVER KNEW THEY WOULD EVER
BE ABLE TO BE IN.
THANK YOU AND PLEASE KEEP YOUR
EYE AND OPEN AS MANY DOORS AS
YOU CAN.
THANK YOU.
>> OKAY.
>> WE WILL RECONVENE AT 3:00
PLEASE.
WE'LL TAKE A LITTLE BREAK,
COFFEE TIME I GUESS FOR SOME OF
YOU.
AND 3:00 WE'LL RECONVENE.
THANK YOU.
WELCOME BACK, EVERYBODY.
WE'RE GOING TO START WITH KEVIN
WILLIAMS, DIRECTOR OF THE OFFICE
OF EQUITY, DIVERSITY, INCLUSION.
KEVIN, ALL YOURS.
>> EXCELLENT.
GOOD AFTERNOON TO THE NIH
DIRECTOR, DR. BERTAGNOLLI,
SENIOR LEADERS AT THE NIH,
STAFF, MEMBERS OF THE ADVISORY
COMMITTEE TO THE DIRECTOR.
THANK YOU FOR INVITING ME TODAY
TO GIVE YOU AN UPDATE ON THE
ONGOING ACTIVITIES OF THE
DISABILITY SUBCOMMITTEE.
NEXT SLIDE PLEASE.
OUR SUBGROUP HAS SPECIFIC ROLES
IN PROJECTS WHICH FOCUS ON
ACCESSIBILITY AS A PRIMARY
ACTIVITY.
THIS INCLUDES OUTREACH TO
INTERNAL GROUPS SUCH AS
ENGAGEMENT AND EMPLOYMENT
INTEREST GROUPS. TO GET INPUT
AND FEEDBACK ON ACCESSIBILITY OF
NIH PROGRAMS AND POLICIES,
REVIEW OF POLICIES FOR
DISCRIMINATORY LANGUAGE, AND
REFERENCES FOR STYLE GUIDES.
COMPLIANCE REVIEWS FOR EXISTING
LAWS, IDENTIFICATION OF
TRAINING, BUILDING OF RESOURCES
FOR THE OFFICE OF HUMAN
RESOURCES AND MY OFFICE, OFFICE
OF DIVERSITY, EQUITY, AND
INCLUSION.
WE'LL COORDINATE WITH AND ACT AS
RESOURCE FOR OTHER OFFICES
WITHIN THE NIH THAT ARE LEADING
ACCESSIBILITY EFFORTS.
NEXT SLIDE PLEASE.
I HAVE THE LUXURY OF BEING
JOINED BY TWO OTHER CO-CHAIRS ON
THIS SUBCOMMITTEE.
THE EXECUTIVE OFFICER AT THE
NATIONAL HUMAN GENOME RESEARCH
INSTITUTE, HELEN, AND DR. ALISON
CERNICH, FROM THE EUNICE KENNEDY
SHRIVER NATIONAL INSTITUTE OF
CHILD HEALTH AND HUMAN
DEVELOPMENT.
WE STARTED TO ORGANIZE OUR
SUBCOMMITTEE INTO THREE WORK
STREAMS, THE FIRST IS TRAINING
AND EDUCATION WHICH IS ASSESSING
CURRENT TRAININGS AND MAKING
RECOMMENDATIONS AND DEVELOPING
NEW TRAININGS RELATED TO
ACCESSIBILITY.
THE SECOND SUBCOMMITTEE IS THE
WORKPLACE ACCESSIBILITY GROUP,
WHICH EXAMINES ACCESSIBILITY OF
PHYSICAL WORKSPACES AND DIGITAL
ACCESSIBILITY OF NIH IN MAKING
RECOMMENDATIONS.
THIRD GROUP, THAT I LEAD,
FOCUSES ON DATA, POLICIES,
PROCEDURES, WE'VE BEEN
EVALUATING CURRENT DATA
PROCESSES AND OTHER PROCESSES
AND PROCEDURES RELATED TO
ACCESSIBILITY.
EACH CO-CHAIR LEADS ONE WORK
STREAM.
WE HAVE A VERY ENGAGED
PRO-ACTIVE SUBCOMMITTEE OF
VOLUNTEERS, APPROXIMATELY 15
FROM ACROSS NIH TO MOVE THE WORK
IN EACH OF THE THREE WORK
STREAMS FORWARD.
THE SUBCOMMITTEE INCLUDES
REPRESENTATIVES WITH LIVED
EXPERIENCES AND DISABILITY
EXPERTISE TO ENSURE WE'RE
INCLUSIVE OF PERSPECTIVES AND IN
DEPTH UNDERSTANDING OF WHAT THE
ISSUES ARE.
WE ARE VERY, VERY EXCITED ABOUT
THE LEVEL OF PROGRESS THAT WE'VE
MADE SINCE LAUNCHING
SUBCOMMITTEE IN FEBRUARY, AND SO
I WOULD SAY WE WERE REMARKING
HOW MUCH JOY IT'S BEEN TO FOCUS
ON THIS PARTICULAR WORK.
NEXT SLIDE PLEASE.
HERE WE HAVE HIGHLIGHTED JUST A
FEW ACCOMPLISHMENTS FROM EACH
GROUP TO DATE.
PLEASE UNDERSTAND THAT THESE DO
NOT FULLY ENCOMPASS EVERYTHING
THAT THE SUBCOMMITTEE IS DOING
TO ENHANCE ACCESSIBILITY AT NIH.
WITH REGARD TO THE TRAINING AND
EDUCATION GROUP, THE GROUP HAS
COLLABORATED WITH THE OFFICE OF
EXTRAMURAL RESEARCH TO CREATE AN
ONLINE RESOURCE FOR RESEARCHERS
WITH DISABILITIES THAT WE HOPE
WILL LAUNCH SOON.
ANOTHER CONSULTATION WITH OFFICE
OF EXTRAMURAL RESEARCH FOCUSES
ON ACCESSIBILITY OF ONLINE
SYSTEMS, USE OF INCLUSIVE
LANGUAGE.
FOR THE WORKPLACE ACCESSIBILITY
GROUP, THEY HAVE DEVELOPED A NOT
ACCESSIBLE REPORTED CAMPAIGN TO
HELP IDENTIFY PHYSICAL SPACES
THAT NEED ENHANCED
ACCESSIBILITY.
THE CAMPAIGN CURRENTLY USES QR
CODE POSTED ACROSS THE NIH
CAMPUS BUT THE CAMPAIGN IS
LOOKING FOR WAYS TO INCREASE
ACCESSIBILITY.
THE GROUP ALSO EXAMINED
ACCESSIBILITY OF CONFERENCE
FACILITY ON BETHESDA MAIN CAMPUS
AND IS DEVELOPING A GUIDE TO
HOST ACCESSIBLE EVENTS FOR USE
ACROSS NIH.
WE HOPE TO PILOT THE GUIDE SOON.
WITH REGARD TO MY PARTICULAR
GROUP, WE HAVE REVISED A
COMPREHENSIVE DATA POLICY TO
PROMOTE TRANSPARENCY AND
INDIVIDUAL PRIVACY PROTECTIONS
FOR NIH EMPLOYEE WORKFORCE DATA.
IN ADDITION THE GROUP IS
CURRENTLY REVIEWING AND UPDATING
REASONABLE ACCOMMODATIONS POLICY
AND PROCEDURES TO INCREASE
INCLUSIVITY OF WORKPLACE
PRACTICES AND TO STREAMLINE
PROCESSES AT THE NIH.
NEXT SLIDE PLEASE.
WITH REGARD TO THE FUTURE WE
HOPE TO CONTINUE THE GREAT WORK
OF THIS SUBCOMMITTEE.
WE'LL CONTINUE WORKING ON SOME
OF THE ITEMS I HAVE ALREADY
HIGHLIGHTED ABOVE RELATED TO
PHYSICAL AND DIGITAL
ACCESSIBILITY AT THE NIH.
WE'LL CONTINUE TO COLLABORATE
WITH OUR KEY PARTNERS AND
CUSTOMERS ACROSS NIH TO CREATE
NEW RESOURCES, FOR THE BUSINESS
DISABILITY COMMUNITY AND IMPROVE
EXISTING NIH SYSTEMS.
WE ALSO PLAN TO CONTINUE WORK
EXAMINING NIH POLICIES AND
PROCEDURES TO ENSURE THAT THE
WORKFORCE DATA REMAINS SECURE
BUT AT THE SAME TIME WOULD ALLOW
US TO USE THOSE DATA IN AN
ACTIONABLE WAY TO IMPROVE OUR
PROGRAMS AND OVERALL
ACCESSIBILITY OF NIH.
THIS WILL IMPROVE WORKPLACE
EXPERIENCE OF ALL OF OUR
EMPLOYEES AND OUR VISITORS TO
OUR CAMPUS.
NEXT SLIDE PLEASE.
I WILL STOP THERE.
THIS HAS ALWAYS BEEN AN EXCITING
SPACE TO BE WORKING IN.
AND I JUST WANT TO REITERATE HOW
MUCH EXCITEMENT WE BRING TO EACH
OF THE MEETINGS AND TO THE WORK
THAT WE'RE DOING IN THIS SPACE.
I BELIEVE WE WILL BE TAKING
QUESTIONS AT THE END SO I'LL
TURN IT OVER TO ADAM POLITIS.
>> LET ME INTRODUCE ADAM
QUICKLY.
YOU, NOT ADAM.
OKAY, I'LL INTRODUCE YOU TO DR.
TARA SCHWETZ, DEPUTY DIRECTOR
FOR PROGRAM COORDINATION,
PLANNING, STRATEGIC INITIATIVES
AT NIH.
>> THANK YOU.
NEXT SLIDE TO GET OURS CUED UP.
GOOD AFTERNOON.
I GUESS EVERYONE IS NOW IN
AFTERNOON.
TODAY WE'RE GOING TO TALK ABOUT
SOME OF THE MORE RESEARCH
FOCUSED ACTIVITIES THAT WE HAVE
TAKEN TO PROMOTE DISABILITY
INCLUSION AND ADVANCE THE
DISABILITY-RELATED HEALTH
DISPARITIES RESEARCH PORTFOLIO
AT NIH.
AND ALSO SHARE ABOUT SOME OF OUR
PLANNED EFFORTS.
IF YOU COULD GO TO THE NEXT
SLIDE.
SOME OF YOU MAY BE AWARE BUT
MORE THAN ONE IN FOUR ADULTS IN
THE UNITED STATES HAVE A
DISABILITY.
SO, I WANT TO REPEAT THAT AND
EMPHASIZE.
THAT'S ONE IN FOUR.
OF COURSE, PEOPLE WITH
DISABILITIES LEAD RICH AND FULL
LIVES, BUT MANY EXPERIENCE A
RANGE OF HEALTH CONDITIONS.
AND NIH IS COMMITTED TO
IMPROVING THE HEALTH AND
WELL-BEING OF PEOPLE WITH
DISABILITIES.
WE'VE GOT A LONG HISTORY OF
SUPPORTING DISABILITY RESEARCH.
BUT RECOGNIZE THAT A LOT OF WORK
STILL REMAINS TO HELPFULLY
-- TO
FULLY UNDERSTAND.
AS WAS MENTIONED EARLIER BACK IN
DECEMBER OF 2022, ADVISORY
COMMITTEE TO WORKING GROUP ON
DIVERSITY SUBGROUP PROVIDED
RECOMMENDATIONS ON PROMOTING
DISABILITY INCLUSION.
WE ESTABLISHED INTERNAL
DISABILITY SUBCOMMITTEE THAT YOU
JUST HEARD A LITTLE BIT ABOUT
FROM KEVIN.
AND AS DR. BERTAGNOLLI MENTIONED
THIS MORNING, NIH HAS ALSO
ISSUED A REQUEST FOR INFORMATION
SEEKING EXTERNAL AND INTERNAL
INPUT ON PROPOSED REVISIONS TO
THE MISSION STATEMENT, INCLUDED
A RECOMMENDATION THAT NIH REDUCE
DISABILITY FROM ITS MISSION
STATEMENT.
NEXT STEPS ARE BEING CONSIDERED,
OF COURSE ADDITIONAL COMMUNITY
ENGAGEMENT PLANNED WITH THAT
EFFORT.
LAST SEPTEMBER THE DIRECTOR OF
THE NATIONAL INSTITUTE ON
MINORITY HEALTH AND HEALTH
DISPARITIES DESIGNATED PEOPLE
WITH DISABILITIES AS A HEALTH
DISPARITY POPULATION ELEVATING
THE NEED FOR RESEARCH TO BETTER
UNDERSTAND COMPLEXITIES THAT
LEAD TO HEALTH OUTCOMES FOR
PEOPLE WITH DISABILITIES.
AND WE KNOW THAT THE SUCCESS OF
THESE AND MANY OTHER EFFORTS
WILL REQUIRE A WELL COORDINATED
APPROACH THAT INCLUDES PEOPLE
AND INPUT FROM ACROSS NIH, ALSO
ACROSS THE COMMUNITY MORE
BROADLY.
SO IF YOU COULD GO TO THE NEXT
SLIDE.
SO, WE BROUGHT ON A TEAM OF
DISABILITY RESEARCH AND POLICY
EXPERTS, INCLUDING THOSE WITH
LIVED EXPERIENCE, TO HELP US
SPEAR HEAD DIFFERENT NIH-WIDE
DISCUSSIONS ON DISABILITY
RESEARCH.
AND WE'RE WORKING WITH A NUMBER
OF PEOPLE FROM ACROSS NIH,
OFFICE OF PORTFOLIO ANALYSIS,
EXTRAMURAL RESEARCH, AND NIMHD
AND SEVERAL OTHERS, AS THE FIRST
STEP TO TAKE A MORE
COMPREHENSIVE LOOK AT OUR
PORTFOLIO IN THIS SPACE.
AND WE'RE STILL WORKING THROUGH
SOME OF THE VARIOUS ASPECTS OF
THIS.
BUT AS ONE MECHANISM TO SHARE
WHAT WE'RE DOING WE ALSO CREATED
A DISABILITY RESEARCH WEB PAGE,
SERVES AS A CENTRAL LANDING
POINT FOR INFORMATION ABOUT
CROSS-AGENCY ACTIVITIES THAT WE
ARE LAUNCHING.
AND WE ALSO ESTABLISHED AN
INTERNAL NIH DISABILITY RESEARCH
COORDINATING COMMITTEE.
NEXT SLIDE.
THIS COMMITTEE IS AN NIH WIDE
FORUM, ACTUALLY SKIP AHEAD TO
THE NEXT ONE IF YOU WILL.
THANKS.
THIS COMMITTEE WILL SERVE AS AN
OPPORTUNITY FOR US TO DISCUSS
ALL THE VARIOUS DIFFERENT HEALTH
ISSUES THAT FACE DISABILITY
COMMUNITIES.
AND IT'S GOING TO SERVE AS A
CATALYST FOR DEVELOPING RESEARCH
TO ADDRESS THOSE ISSUES.
ALSO HELP US AS WE CONSIDER
RESEARCH TRAINING AND CAREER
DEVELOPMENT ISSUES THAT ARE
FOCUSED ON PEOPLE WITH
DISABILITIES.
SO, THIS GROUP WAS FORMED A FEW
MONTHS AGO AND THEY HAVE REALLY
BEEN TREMENDOUS AND ALSO
TREMENDOUSLY BUSY.
GO TO THE NEXT SLIDE.
BECAUSE THEY HAD AN INITIAL
TASK.
AND REALLY ONE OF THE THINGS WE
ASKED THEM TO DO RIGHT OFF THE
BAT WAS TO DEVELOP AN NIH
STRATEGIC PLAN FOR DISABILITY
RESEARCH.
AND OF COURSE DOWN THE ROAD ONCE
THIS PLAN IS TOGETHER THERE WILL
BE A GROUP TO FACILITATE ITS
IMPLEMENTATION.
BUT IN ADDITION TO THE PLAN, IT
IS A COORDINATING BODY.
SO IT'S GOING TO IDENTIFY AND
FOSTER COLLABORATIONS AND OTHER
ACTIVITIES RELATED TO DISABILITY
RESEARCH, THINGS LIKE TRAINING
ACTIVITIES, MANY OTHERS.
AND THEY ARE LOOKING THROUGH THE
CROSS-AGENCY LENS, ACROSS ALL OF
NIH, AND HOW WE CAN PARTNER
TOGETHER AND WORK TOGETHER, BUT
ALSO HOW WE INTERSECT WITH AN
INTERACT WITH OTHER FEDERAL
AGENCIES AND OTHER
ORGANIZATIONS.
NEXT SLIDE.
I'M REALLY GRATEFUL THAT IT IS
BEING SPEARHEADED BY THREE
CO-CHAIRS FROM NIMHD, NICHD, AND
SOMEONE ON MY TEAM FROM THE
O.D., COMPOSED OF 69 MEMBERS
REPRESENTING VIRTUALLY ALL
INSTITUTES AND CENTERS ACROSS
NIH.
THIS ALSO -- A SHOUT OUT FOR THE
EXEC SEC FOR THAT GROUP, TAKING
ON THE BIG LIFT OF COORDINATING
THIS DEVELOPMENT OF THE
STRATEGIC PLAN.
GO TO THE NEXT SLIDE.
ALSO JUST WANT TO MENTION THE
WRITING TEAM BRIEFLY WHO HAS
STEPPED UP TO COMMIT TO DRAFTING
THE STRATEGIC PLAN AND REALLY
GRATEFUL FOR ALL OF THEIR
EFFORTS, AS THAT IS REALLY FULLY
UNDERWAY AT THIS MOMENT.
GO TO THE NEXT SLIDE.
SO IN ADDITION TO OUR INTERNAL
EXPERTS, WE'RE ALSO -- WE ALSO
RECOGNIZE HOW CRITICAL IT IS TO
MEANINGFULLY ENGAGE WITH THE
COMMUNITY.
AND TO OPEN A DIALOGUE, IN
PARTICULAR AS WE'RE IN PLANNING
PHASE.
NEXT SLIDE.
SO IN DOING SO WE'RE AIMING TO
BUILD TRUST, HELP US UNDERSTAND
THE COMMUNITY'S CONCERNS, NEEDS,
PERSPECTIVES.
WE ALSO HOPE TO RAISE AWARENESS
ABOUT THE STRATEGIC PLANNING
PROCESS.
AND HAVE A MECHANISM TO, YOU
KNOW, PROMOTE PARTICIPATION.
OF COURSE IT GIVES US A WAY TO
GATHER A RANGE OF CRITICAL
FEEDBACK THAT'S GOING TO HELP
AND HAS HELPED SHAPE THE
STRATEGIC PLAN FRAMEWORK.
NEXT SLIDE.
SO, FROM LATE OCTOBER TO
NOVEMBER WE'VE BEEN REALLY BUSY.
WE HOSTED SIX VIRTUAL COMMUNITY
ROUNDTABLE DISCUSSIONS TO INFORM
THE DEVELOPMENT OF THIS
STRATEGIC PLAN FRAMEWORK.
AND WE INVITED PANELISTS FOR
THESE ROUNDTABLES THAT
REPRESENTED A REALLY LARGE RANGE
OF INTERESTED GROUPS.
WE HAD RESEARCHERS, PEOPLE WITH
LIVED EXPERIENCE WITH
DISABILITIES, HAD CLINICIANS,
PROFESSIONAL ASSOCIATIONS, AND
ADVOCACY ORGANIZATIONS.
NEXT SLIDE.
AND THEY ALL PROVIDED REALLY
INCREDIBLE THOUGHTFUL FEEDBACK
ON A SERIES OF QUESTIONS THAT WE
POSED TO THEM.
SO THEY ARE LISTED HERE.
WE STARTED WITH THREE BROAD HIGH
LEVEL QUESTIONS.
WHAT ARE THE SCIENTIFIC
OPPORTUNITIES AND CHALLENGES
THAT WE SHOULD BE ADDRESSING?
HOW CAN WE ENCOURAGE AND CLEAR
THE WAY FOR NEW INVESTIGATORS TO
COME INTO THE FIELD?
AND HOW CAN WE IMPROVE INCLUSION
OF INDIVIDUALS WITH DISABILITIES
IN CLINICAL RESEARCH?
WE HEARD A NUMBER OF GREAT
SUGGESTIONS.
I'M NOT GOING THROUGH ALL.
WE'LL HAVE THAT INFORMATION
THAT'S AVAILABLE AND POSTED ON
THE WEBSITE.
I WANTED TO HIGHLIGHT TWO
EXAMPLES OF SOME FEEDBACK WE
GOT.
WE HEARD OVER AND OVER AGAIN THE
NEED FOR GENUINE AND MEANINGFUL
PARTICIPATION OF PEOPLE WITH
DISABILITIES IN RESEARCH.
AND THAT'S NEEDED THROUGHOUT ALL
STAGES OF THE RESEARCH PROCESS.
THE OTHER THING I'LL MENTION IS
JUST THAT THERE IS A PUSH FOR
RESEARCH THAT AIMS TO IMPROVE
THE QUALITY OF LIFE OF
INDIVIDUALS WITH DISABILITIES,
AND THAT HELPS SUPPORT THEM
MEETING DEMANDS OF THEIR
ENVIRONMENT IN WHICH THEY LIVE.
AND WE HAD A NUMBER OF PEOPLE, I
FORGET THE TOTAL NOW, BUT I FEEL
LIKE WE HAD AT LEAST 60 PEOPLE
WHO PARTICIPATED AS PANELISTS IN
THESE ROUNDTABLES AND I'M
GRATEFUL TO THEM FOR SHARING
PERSPECTIVES AND PROVIDING SO
MANY THOUGHTFUL INSIGHTS AND
WE'VE INCORPORATED THEM INTO OUR
STRATEGIC PLANNING EFFORT.
NEXT SLIDE.
SO AFTER WRAPPING UP ALL OF
THOSE ROUNDTABLES, WE HELD A
CAPSTONE EVENT, A TOWN HALL A
COUPLE WEEKS AGO.
AND IT HIGHLIGHTED NIH'S
COMMITMENT TO ADVANCING HEALTH
AND WELL-BEING OF PEOPLE WITH
DISABILITIES.
DR. BERTAGNOLLI AND PEREZ-STABLE
AND CERNICH PARTICIPATED.
WE PROVIDED A PREVIEW OF THE
DRAFT FRAMEWORK OF THE NIH
STRATEGIC PLAN FOR DISABILITY
HEALTH RESEARCH WHICH YOU'LL
HEAR ABOUT IN A MOMENT, AND THEN
ANSWERED A VARIETY OF QUESTIONS.
AND IF YOU'RE INTERESTED THERE'S
MORE INFORMATION THAT CAN BE
FOUND AT THE DPCPSI WEBSITE.
SO GO TO THE NEXT SLIDE.
THE FINAL THING I'LL SAY BEFORE
TURNING IT OVER TO ADAM, TO HELP
PUT THIS ALL IN PERSPECTIVE,
WHAT WE'VE DONE AND WHERE WE'RE
HEADED, AND THIS TIMELINE HAS
IMAGES OF INDIVIDUALS WITH
DISABILITIES, VISIBLE AND
INVISIBLE.
IT OUTLINES THE VARIOUS
ACTIVITIES THAT I JUST
DESCRIBED.
BUT AS WE WERE LOOKING FORWARD
TO WANT TO POINT OUT A FEW
THINGS.
OVER THE IN NEXT FEW MONTHS
WE'RE GOING TO ANALYZE THE
RESULTS FROM AN RFI THAT SHOULD
BE GOING OUT TODAY.
I THINK IT'S PROBABLY OUT AT
THIS MOMENT.
AND INCORPORATE THE FEEDBACK
THAT WE GOT INTO THE STRATEGIC
PLAN.
WE ALSO MAY BE HOLDING
ADDITIONAL ENGAGEMENT ACTIVITIES
AS NEEDED.
AND OUR GOAL IS TO RELEASE THE
PLAN NEXT SUMMER, SUMMER OF
2025.
WITH THAT I'LL TURN IT OVER TO
ADAM POLITIS WHO WILL RUN
THROUGH THE STRATEGIC PLAN
FRAMEWORK WE PUT TOGETHER.
>> THANK YOU VERY MUCH, DR.
SCHWETZ.
GOOD AFTERNOON, EVERYONE.
NEXT SLIDE PLEASE.
WE CAN GO TO THE NEXT ONE.
SO DR. SCHWETZ MENTIONED THE
DRAFT STRATEGIC PLAN FRAMEWORK
WAS DEVELOPED BY THE RESEARCH
COORDINATING COMMITTEE, DRCC FOR
SHORT.
WHICH HAS BROAD REPRESENTATION
FROM ACROSS NIH MANY INSTITUTES,
CENTERS, OFFICES, CONSIDERABLE
ASPECTS IN DISABILITY RESEARCH,
INCLUDING MANY WITH LIVED
EXPERIENCE WITH DISABILITY.
THE DRCC UTILIZED EXPERTISE TO
DEVELOP DRAFT FRAMEWORK AND
FEEDBACK BY MANY INDIVIDUALS AND
ORGANIZATIONS WHO PARTICIPATED
IN THE COMMUNITY ENGAGEMENT
EVENTS.
THE DRCC RECOGNIZES PEOPLE WITH
DISABILITIES MAY EXPERIENCE A
RAIN OF MEDICAL CONDITIONS, AS
WELL AS NON-MEDICAL FACTORS IN
THE ENVIRONMENT THAT LEAD TO
POOR HEALTH OUTCOMES SUCH AS
DISCRIMINATION, INACCESSIBLE
FACILITIES.
RESEARCH THAT SEEKS TO
UNDERSTAND AND ADDRESS EFFECTS
OF BOTH MEDICAL OR HEALTH
CONDITIONS AS WELL AS SOCIAL AND
ENVIRONMENTAL FACTORS ON THE
HEALTH AND WELL-BEING OF PEOPLE
WITH DISABILITIES, DISABILITY
HEALTH RESEARCH, THE TITLE FOR
THE STRATEGIC PLAN MOVING
FORWARD WOULD BE NIH STRATEGIC
PLAN FOR DISABILITY HEALTH
RESEARCH.
FIRST CROSS-CUTTING THEMES THAT
CUT ACROSS GOALS.
STRATEGIC GOALS THEMSELVES, OVER
A FIVE YEARS PERIOD BEGINNING IN
FY 2016 AND POTENTIAL
OPPORTUNITIES THAT COULD BE
TAKEN TO ACHIEVE STRATEGIC
GOALS.
NEXT SLIDE PLEASE.
CROSS-CUTTING THEMES INCLUDED IN
THE DRAFT FRAMEWORK WITH PUBLIC
PARTICIPATION AND COMMUNITY
ENGAGEMENT, ACCESSIBILITY,
COMPLEXITY AND HETEROGENEITY,
DYNAMICS OF DISABILITY.
THE PUBLIC PARTICIPATION AND
COMMUNITY ENGAGEMENT THEME
EMPHASIZES BIOMEDICAL AND
BEHAVIORAL RESEARCH COMMUNITY
SHOULD INVOLVE PEOPLE WITH
DISABILITIES IN IDENTIFYING
RESEARCH PRIORITIES AND BUILD
TRUST-BASED LONG-TERM AND
TWO-WAY RELATIONSHIPS WITH
DISABILITY COMMUNITIES.
ACCESSIBILITY THEME SPACE THAT
RESEARCH AND HEALTH CARE
FACILITIES, EQUIPMENT,
TECHNOLOGY AND INFORMATION MUST
BE ACCESSIBLE SO ALL PEOPLE
INCLUDING PEOPLE WITH
DISABILITIES CAN FULLY USE THEM.
THE COMPLEXITY AND HETEROGENEITY
THEME HIGHLIGHTS DISABILITY IS
NOT MONOLITHTIC, THEY ARE
MULTI-FACETED WITH A WIDE RANGE
OF EXPERIENCES.
THIS MUST BE ACKNOWLEDGED IN
ORDER TO CONDUCT MEANINGFUL
RESEARCH AND COMMUNITY
ENGAGEMENT.
FINALLY, THE DYNAMICS OF
DISABILITY THEME HIGHLIGHTS
DISABILITY IS DYNAMIC PROCESS
INVOLVING INTERACTION OF MEDICAL
CONDITIONS THAT MAY FLUCTUATE
OVER TIME WITH VARIABLE
BEHAVIORAL, SOCIOCULTURAL AND
ENVIRONMENTAL FACTORS.
WHEN CONDUCTING RESEARCH THESE
SHOULD BE INCORPORATED INTO
RESEARCH DESIGNS, METHODS,
MEASURES.
NEXT SLIDE PLEASE.
THE DRAFT FRAMEWORK INCLUDES
FOUR STRATEGIC GOALS.
FIRST GOAL TO SUPPORT HIGH
QUALITY INNOVATIVE IMPACTFUL
RESEARCH TO IMPROVE HEALTH AN
WELL-BEING OF PEOPLE WITH
DISABILITIES OF ALL AGES.
SECOND GOAL TO BUILD MEANINGFUL
INTERNAL AND EXTERNAL
PARTNERSHIPS TO PROMOTE
DISABILITY HEALTH RESEARCH.
THIRD GOAL PROMOTE ENGAGEMENT
AND INCLUSION OF PEOPLE WITH
DISABILITIES IN THE BIOMEDICAL
AND BEHAVIORAL RESEARCH
ECOSYSTEM.
FOURTH TO DEVELOP A WORK FORCE
THAT INCLUDES RESEARCHERS WITH
DISABILITIES AND TRAINED IN
DISABILITY HEALTH RESEARCH.
NEXT SLIDE PLEASE.
WITH REGARDS TO GOAL 1, WE KNOW
THAT KNOWLEDGE GAPS EXIST
REGARDING HEALTH AND WELL-BEING
OF PEOPLE WITH DISABILITIES.
RESEARCH IS NEEDED TO FURTHER
ENSURE AND ADDRESS HEALTH NEEDS
OF PEOPLE WITH DISABILITIES
ACROSS THE LIFESPAN.
SUPPORT FOR DEVELOPING RESOURCES
AND INFRASTRUCTURE IS ALSO
NEEDED TO ADVANCE THE STUDY OF
DISABILITY HEALTH.
NEXT SLIDE PLEASE.
TO ACHIEVE GOAL 1 THERE ARE A
RANGE OF ACTIONS THAT COULD BE
TAKEN.
WE HIGHLIGHT SEVERAL POTENTIAL
OPPORTUNITIES AS EXAMPLES.
THE FIRST IS TO DEVELOP MEASURES
OF DISABILITY THAT COULD EASILY
BE COLLECTED WITH OTHER
DEMOGRAPHIC DATA.
WITHOUT ADEQUATE DATA, EFFORTS
TO IDENTIFY HEALTH AND HEALTH
CARE DISPARITIES EXPERIENCED BY
PEOPLE WITH DISABILITIES ARE
HINDERED.
ANOTHER OPPORTUNITY TO TRACK
LONGITUDINAL HEALTH OUTCOMES OF
PEOPLE WITH DISABILITIES,
EXAMINING MEDICAL AND
NON-MEDICAL FACTORS THAT
CONTRIBUTE TO HEALTH OUTCOMES.
NIH COULD ENCOURAGE RESEARCH TO
DEVELOP INTERVENTIONS TO ADDRESS
HEALTH AND HEALTH CARE
DISPARITIES BY PEOPLE WITH
DISABILITIES.
FINALLY PROMOTE DEVELOPMENT OF
TECHNOLOGIES LEVERAGE EXISTING
TECHNOLOGIES.
GOAL 2 WE RECOGNIZE GENUINE
PARTNERSHIPS ARE NEEDED TO
ADVANCE RESEARCH ON THE HEALTH
AND WELL-BEING OF PEOPLE WITH
DISABILITIES INCLUDING
PARTNERSHIPS AMONG NIH
INSTITUTES AND CENTERS AND OTHER
FEDERAL AGENCIES AND BETWEEN NIH
AND EXTRAMURAL COMMUNITY
INCLUDING PEOPLE WITH LIVED
EXPERIENCES, BY UTILIZING
SKILLS, EXPERTISE AND PARTNERS
INTERNAL AND EXTERNAL TO NIH.
NIH-SUPPORTED RESEARCH CAN BE
ENHANCED AND COMMUNICATED MORE
EFFECTIVELY.
NEXT SLIDE PLEASE.
TO ACHIEVE GOAL 2 SOME POTENTIAL
OPPORTUNITIES INCLUDE
DESIGNATING CENTRAL POINT OF
CONTACT FOR DISABILITY HEALTH
RESEARCH AND NIH TO FACILITATE
AND STREAMLINE ENGAGEMENT WITH
THE PUBLIC, PARTNERING WITH NIH
INSTITUTES, CENTERS, OFFICES AND
COMMUNITY ORGANIZATIONS TO
DEVELOP DISABILITY HEALTH
RESEARCH EVENTS, OBTAIN INPUT ON
RESEARCH TOPICS, COMMUNICATE AND
DISSEMINATE RESEARCH FINDINGS.
ALSO EXPANDING COLLABORATIONS
WITH OTHER FEDERAL AGENCIES THAT
HAVE EXPERTISE AN CONDUCTING
OUTREACH TO INCREASE AWARENESS
OF INITIATIVES AT NIH IN ORDER
TO INCREASE NUMBER OF
APPLICATIONS TO THESE
INITIATIVES.
NEXT SLIDE PLEASE.
GOAL 3 WE BELIEVE MEANINGFUL
PARTICIPATION IN THE RESEARCH
PROCESS IS VITAL INCLUDING
ENGAGEMENT AT ALL STAGES OF THE
SCIENTIFIC PROCESS FROM
IDENTIFYING RESEARCH PRIORITIES
TO DESIGNING, REVIEWING,
CONDUCTING, COMMUNICATING
RESULTS OF STUDIES.
IN ADDITION, WE NEED TO PREVENT
UNNECESSARY EXCLUSION OF PEOPLE
WITH DISABILITIES, IN RESEARCH
STUDIES, STRENGTHENING
SIGNIFICANCE AND GENERALIZABLE.
WE NEED TO PROMOTE COLLECTION OF
DATA IN NIH FUNDED RESEARCH,
DONE IN A SAFE, SECURITY,
NON-STIGMATIZING MANNER.
NEXT SLIDE PLEASE.
TO ACHIEVE GOAL 3 WE HIGHLIGHT
SEVERAL OPPORTUNITIES.
FIRST TO INCLUDE PEOPLE WITH
LIVED EXPERIENCE WITH DISABILITY
IN ALL STAGES OF THE PROCESS.
ANOTHER OPPORTUNITY TO ENCOURAGE
DATA COLLECTION IN ALL
NIH-SUPPORTED RESEARCH.
NIH AND NIH-SUPPORTED
INVESTIGATORS COULD DEVELOP
ACCESSIBILITY TOOL KITS FOR
CLINICAL RESEARCH.
INACCESSIBLE FACILITIES ARE
BARRIERS AS PARTICIPANTS IN
STUDIES.
FINALLY, FOR HEALTH CONDITIONS,
NIH COULD SUPPORT DEVELOPMENT,
ADAPTATION FOR PEOPLE WITH
DISABILITIES EXPERIENCING THESE
CONDITIONS.
NEXT SLIDE PLEASE.
LAST GOAL WE HIGHLIGHT RESEARCH
WITH DISABILITIES ARE OVERLOOKED
RESEARCHERS WITH VALUABLE
PERSPECTIVES.
SHOULD BE PROVIDED WITH SUPPORTS
AND ACCOMMODATIONS IN ORDER TO
BE SUCCESSFUL IN RESEARCH
CAREERS.
IN ADDITION FOR BOTH RESEARCHERS
AND CLINICIANS WITH AND WITHOUT
DISABILITIES PROVIDING TRAINING
AND DISABILITY HEALTH RESEARCH
WILL ACCELERATE IMPROVEMENT IN
HEALTH CARE FOR DISABILITY
POPULATIONS.
NEXT SLIDE PLEASE.
POTENTIAL OPPORTUNITIES FOR LAST
GOAL INCLUDE SUPPORTING
RESEARCHERS WITH ALL TYPES OF
DISABILITIES THROUGHOUT CAREERS,
SO THEY CAN ADVANCE RESEARCH IN
BIOMEDICAL AND BEE SCIENCES,
DEVELOPING AND PROMOTING
INSTITUTIONAL TRAINING,
INCREASING COMPETENCY AND
REPRESENTATION IN VARIOUS
RESEARCH AND RESEARCH
ADMINISTRATION ROLES.
FINALLY SUPPORTING STAFF,
EMPLOYERS, SUPERVISORS TO
IMPLEMENT INCLUSIVE DESIGN
PRACTICES AND ENSURE
ACCESSIBILITY OF EVENTS AND
WORKPLACES.
NEXT SLIDE PLEASE.
AND NEXT SLIDE.
SO TO OBTAIN INPUT AND FEEDBACK
ON DRAFT STRATEGIC PLAN
FRAMEWORK TODAY NIH ISSUED THIS
RFI, OPEN FOR 90 DAYS, CLOSES ON
MARCH 12, 2025.
IT PROVIDES BACKGROUND ON DAY
CARE CENTERS AND -- PROVIDES
BACKGROUND ON DISABILITY,
INCLUDES A DRAFT FRAMEWORK, AND
INSTRUCTIONS HOW TO PROVIDE
FEEDBACK.
NIH IS INTERESTED IN FEEDBACK ON
FRAMEWORK AND WHETHER ADDITIONAL
THEMES TO BE CONSIDERED,
APPROPRIATENESS OF GOALS AND
OPPORTUNITIES INCLUDING
POTENTIAL BENEFITS, DRAW BACKS
OR CHALLENGES, SUGGESTSES TO
MEASURE PROGRESS, AND
SUGGESTIONS FOR WAYS NIH CAN
SHARE STRATEGIC PLAN AND
COMMUNICATE PROGRESS, SUCCESS,
IMPACT.
RFI WILL BE DISSEMINATED VIA
MULTIPLE CHANNELS, LISTED IN THE
GUIDE, SOCIAL MEDIA, E-MAILS AND
TOWN HALLS, CURRENTLY LISTED ON
DPCPSI DISABILITY RESEARCH
WEBSITE.
WE LOOK FORWARD TO YOUR INPUT
AND FEEDBACK AND HOPE YOU'LL
SHARE THE RFI.
I'LL HAND IT BACK TO DR.
SCHWETZ.
>> YES, PLEASE DO DISTRIBUTE
THAT WIDELY.
YOU ALL SHOULD BE GETTING AN
E-MAIL FROM ME IN A FEW MINUTES
WITH INFORMATION AND LINK.
I DID WANT TO MENTION ONE MORE
ACTIVITY.
I HOPE MANY OF YOU ARE FAMILIAR
WITH THE NIH COUNCIL OF
COUNCILS.
RUSS IS BECAUSE HE'S ON IT.
IT IS AN ADVISORY COMMITTEE ON
MATTERS RELATING TO DPCPSI.
AND AT THE LAST MEETING BACK IN
SEPTEMBER WE DISCUSSED SOME OF
THE EFFORTS YOU ALL JUST HEARD
ABOUT TODAY AND RAISED IDEA OF
ESTABLISHING A STANDING COUNCIL
OF COUNCILS DISABILITY RESEARCH
WORKING GROUP.
NEXT SLIDE.
SO THIS GROUP IS GOING TO
PROVIDE INPUT ON ACTIVITIES TO
HELP US GROW THE FIELD, THINK
ABOUT PRIOR SCIENTIFIC AREAS,
PARTICULARLY AS WE THINK ABOUT A
WHOLE OF NIH FOCUS.
AND WEIGH IN ON STRATEGIES TO
INCREASE THE WORKFORCE OF
INVESTIGATORS WITH DISABILITIES.
THE GROUP IS ALSO GOING TO HELP
US CONSIDER OPTIMIZING OUTREACH
TO DISABILITY COMMUNITIES, A
CRUCIAL AND CRITICAL PART OF THE
PROCESS.
SO WE HAVEN'T YET FORMALLY
KICKED THIS OFF BUT WILL BE
DOING SO SOON AND KIND OF
LOOKING FORWARD I GUESS MORE TO
SOME OF THE ACTIVITIES THAT ARE
GOING TO COME OUT OF THAT
GROUP'S EFFORT.
SO WITH THAT I THINK WE'LL TAKE
QUESTIONS AND OPEN IT UP OR TURN
IT BACK.
>> GREAT.
IF WE COULD PULL DOWN THE SLIDES
PLEASE AND SEE EVERYBODY.
ANY COMMENTS OR QUESTIONS?
YES, PLEASE, COREY, YOU'RE UP
FIRST.
>> YES, I'M ASTOUNDED IN TERMS
OF GREAT WORK AND PROGRESS THAT
NIH CONTINUES TO MAKE IN THIS
PARTICULAR SPACE OF DISABILITY.
YOU ALL HAVE A LOT OF GREAT WORK
GOING ON THAT, AGAIN, INCLUDES
INPUT FROM PEOPLE WITH
DISABILITIES AND OVER IN THE
DISABILITY COMMUNITY.
I THINK THE STRATEGIC PLAN IN
HEALTH RESEARCH IS JUST A
VISIONARY IDEA THAT HOPEFULLY
WILL SERVE AS A GUIDE POST FOR
THE AGENCY IN YEARS TO COME, IN
TERMS OF ADVANCING DISABILITY IN
THE NIH CULTURE.
WE HAVE A COUPLE OF POINTS OR
QUESTIONS, PER SE.
SO MY FIRST QUESTION IS IN TERMS
OF GOAL NUMBER 3 IN THE DRAFT
STRATEGIC PLAN AROUND PROMOTING
PEOPLE WITH DISABILITIES, ONE OF
THE THINGS THAT HAS COME UP TO
ME IN TERMS OF ENSURING SAFETY,
IF YOU WILL, OR ENSURING THAT
PEOPLE ARE WILLING TO DISCLOSE
THEIR DISABILITY IS POTENTIAL
FOR NEGATIVE RAMIFICATIONS, NOT
JUST WITHIN NIH BUT ACROSS
COLLEGE CAMPUSES, ACROSS
RESEARCH INSTITUTES, WHERE
INDIVIDUALS WHO HAVE PARTICULAR
DISABILITIES AND WHO FEEL THAT
THE DISCLOSURE MIGHT HAVE
NEGATIVE IMPLICATIONS ESPECIALLY
WITHIN THE INTELLECTUAL REALM OF
SCIENCE, WHERE ONE'S ABILITY TO
SYNTHESIZE INFORMATION, ONE'S
ACADEMIC PROWESS IS HELD AT THE
HIGHEST LEVEL, SOME INDIVIDUALS
WITH DISABILITIES WHO MAY
HAVE -- MAY BE CONSCIOUS OF
SHARING THEIR DISABILITY STATUS
IN THIS REGARD SO ONE OF THE
QUESTIONS IS HOW DO WE AND HOW
DOES NIH PROMOTE A CULTURE IN
WHICH INDIVIDUALS WHO MAY NEED
SUPPORT, WHO MAY HAVE INVISIBLE
DISABILITIES, AND WHO MAY NEED
SUPPORT, WHO MAY HAVE
DISABILITIES THAT OTHER
SCIENTISTS MAY LOOK UPON THESE
AS A NEGATIVE, SO HOW WOULD WE
PROMOTE THOSE INDIVIDUALS TO
ACTUALLY DISCLOSE, TO ACTUALLY
REQUEST ACCOMMODATIONS, THAT
THEY MAY NEED TO BE SUCCESSFUL,
INTRAMURALLY, IN THE NIH, AS
WELL AS EXTRAMURALLY,
EXTERNALLY, THOSE RESEARCHERS AT
INCORPORATION TUITION --
INSTITUTIONS AROUND THE COUNTRY.
I ASKED THE QUESTION AROUND LACK
OF DATA AT ONE OF THE ICD
MEETINGS, LACK OF DATA FOR
INDIVIDUALS WITH DISABILITIES
AND GRANT PROCUREMENT.
AND ONE OF THE RESPONSES IN
TERMS OF THAT QUESTION HAD TO DO
WITH INDIVIDUALS -- HAD TO DO
WITH NIH NOT REALLY BEING ABLE
TO IDENTIFY THE MEMBER OF
RESEARCH SCIENTISTS THAT
ACTUALLY HAVE DISABILITIES.
SO I'VE SAID A LOT BUT THE
QUESTION IS WHAT SORTS OF WAYS
DOES NIH HAVE IN MIND IN TERMS
OF STRATEGIC PLANNING TO REALLY
BE ABLE TO ENHANCE THE CULTURE
WHICH INDIVIDUALS WITH
DISABILITY, HIDDEN DISABILITIES,
TO DISCLOSE THEY HAVE A
DISABILITY AND FEEL LIKE THEY
CAN GET SUPPORT AND
ACCOMMODATIONS AND WOULD NOT BE
NEGATIVELY IMPLICATED FOR
DISCLOSING.
>> ELIZABETH, DO YOU WANT TO
JUMP IN ON THIS ONE?
>> I JUST WANTED TO REITERATE
THE SAME THING, THAT COREY SAID
IS IMPORTANT.
I'VE SEEN IN MY LAB FIRST HAND
OUR ABILITY TO USE NON-NIH
DISCRETIONARY FUNDS TO HAVE
ACCOMMODATIONS FOR ONE TECH THAT
WAS HEARING IMPAIRED, AND, YOU
KNOW, PROVIDING ZOOM MEETINGS
AND BUY MICROPHONES.
WHEN WE STARTED DOING THIS,
WHICH HADN'T OCCURRED TO ME
BEFORE, IN THE LAST YEAR HE WAS
IN THE LAB IT WAS INCREDIBLE HOW
HIS PERSONALITY AND PRODUCTIVITY
CHANGED, HE'S IN UCSF NOW
MEDICAL SCHOOL NOW, THEY SAID NO
TO THESE THINGS.
THEY DIDN'T ALLOW US TO NIH
FUNDS, SO THIS MAY BE A SMALL
CHANGE, WELL, IT'S NEVER SMALL,
BUT REALLY CHANGES THE LIVES OF
PEOPLE WITH DISABILITIES.
IT'S INCLUSIVE.
IT'S IMPORTANT.
AND AS I SAID, I'VE SEEN TWO
CASES, BOTH HEARING
DISABILITIES, ONE IN MY LAB AND
EFFECT WAS INCREDIBLE.
I THINK CORY IS RIGHT, IT WOULD
BE IMPORTANT TO THINK ABOUT
SPECIFIC CHANGES AND THINGS THAT
WILL ALLOW THE SCIENTIFIC
WORKFORCE TO SUPPORT THESE
WONDERFUL INDIVIDUALS.
>> A COUPLE THINGS TUCKED INTO
THAT.
I WOULD JUST SAY GENERALLY,
COREY, YOU'RE ABSOLUTELY RIGHT.
THERE'S A LOT OF VARIABILITY IN
THE COMFORT LEVEL PEOPLE HAVE,
WHETHER OR NOT THEY HAVE A
DISABILITY.
WE MAY BE EVEN SEEING A LITTLE
BIT OF GENERATIONAL DIFFERENCES
WITH THAT COMFORT LEVEL AS WELL.
AND OF COURSE ONE OF THE THINGS
THAT THE GROUP HAS BEEN TALKING
ABOUT AND WILL CONTINUE TO TALK
ABOUT AND FIGURE OUT WAYS TO
ADDRESS THIS IS HOW WE CAN
INCREASE THE DATA THAT WE HAVE
ON THE FOLKS THAT WE'RE FUNDING
AND PART OF THAT AS YOU'VE
INDICATED IS KIND OF PROMOTING
THAT CULTURE WHERE PEOPLE FEEL
COMFORTABLE WITH DISCLOSING THAT
INFORMATION, YOU KNOW,
PRIVATELY.
THE OTHER THING I WOULD JUST
POINT OUT IN TERMS OF THE
STATEMENT MADE, THERE'S AN
OPPORTUNITY TO APPLY FOR
SUPPLEMENTS FOR ACCOMMODATIONS
SO IT'S NOT THAT THERE AREN'T
RESTRICTIONS THERE.
THERE'S PATHWAYS, MECHANISMS FOR
THAT.
MAYBE WE COULD DO A BETTER JOB
RAISING AWARENESS SO PEOPLE
UNDERSTAND WHAT IS AVAILABLE.
I DON'T KNOW IF ADAM WANTS TO
WEIGH IN OR KEVIN, TALKING ABOUT
THE INTERNAL OF COURSE.
>> YEAH, THANK YOU.
TO HIGHLIGHT THIS IS A CULTURAL
SHIFT THAT AS DR. SCHWETZ
MENTIONED.
THERE'S VARYING LEVELS OF
COMFORT, SELF-IDENTIFYING,
GENERATIONAL DIFFERENCES,
DIFFERENCES BY DISABILITY TYPE
WITH A HIERARCHY OF STIGMA WITH
DIFFERENT TYPES OF DISABILITIES.
FROM NIH PERSPECTIVE TALKING
OPENLY AND LEADING THE WAY IS A
FIRST STEP.
MAYBE WE COULD HAVE BEST
PRACTICES TO SHARE WITH
EXTRAMURAL INSTITUTIONS.
BUT IT IS SOMETHING NOT UNIQUE
TO BIOMEDICAL RESEARCH.
IT'S ACROSS ANY AREA THAT THE
NEED -- TO GET PEOPLE TO
SELF-DISCLOSE BECAUSE YOU WANT
TO SERVE THEM BALANCING WITH
PRIVACY AND CONFIDENTIAL
CONCERNS BECAUSE THERE'S
DISCRIMINATION PEOPLE
EXPERIENCE.
IT'S LONGER-TERM CULTURE SHIFTS
BUT WE'RE LOOKING AT WAYS TO
DEVELOP POLICIES TO ENABLE THAT
SHIFT.
>> I WANT TO CHIME IN BECAUSE
NOBODY'S HAD TO SAY IT BECAUSE
IT'S GOTTEN TO BE AN UNDERLYING
ASSUMPTION, UNDERLYING FEATURING
WHAT WE DO HERE.
AND THAT IS THAT THE FIRST PLACE
WE START WITH IS ASKING PEOPLE
WHO HAVE EITHER HIDDEN OR
VISIBLE DISABILITIES, YOU KNOW,
TAKING THE QUESTION TO THEM,
TELL US WHAT YOU WANT, TELL US
HOW YOU MIGHT FEEL ABOUT
PARTICIPATING IN RESEARCH AND
TELL US WHAT WE CAN DO THAT
MIGHT MAKE YOU FEEL MORE
COMFORTABLE AND MORE SUPPORTED.
SO WE ALSO TRY REALLY HARD IN
EVERYTHING WE DO NOT JUST TO
ASSUME WE KNOW AND TO ASK THOSE
QUESTIONS THROUGH, YOU KNOW,
FOCUS GROUPS AND EVEN IN
INDIVIDUAL, YOU KNOW, THROUGH
INDIVIDUAL RESEARCH COMMUNITIES
SO THAT WE CAN LEARN FROM THAT
POPULATION HOW WE CAN DO THIS
BETTER.
RUSS?
>> YEAH, ALSO I PUT MY TWO CENTS
IN, THIS IS A FABULOUS
INITIATIVE, HUGE POPULATION AS
WAS POINTED OUT, AND IN MY NECK
OF THE WOODS WE OBVIOUSLY WORK A
LOT WITH VISUALLY IMPAIRED
PEOPLE WHO HAVE VISUAL
DISABILITIES.
I'VE HAD THE SAME EXPERIENCE
HAVING LOW VISION FOLKS WORK IN
MY LAB, JUST REALLY OPENED UP A
WHOLE WORLD BUT THERE'S A LOT OF
WORK THAT GOES INTO MAKING THAT
TYPE OF RESEARCH ACCESSIBLE.
A TECHNICAL QUESTION, WHAT
DEFINITION OF DISABILITY ARE WE
USING FOR THESE?
THERE ARE A BUNCH OF THEM.
THERE'S THE ADA, THE WHOR R.
-- THE
W.H.O., EDUCATIONAL, IS THERE
CONSENSUS WHICH FRAMEWORK, ARE
WE GENERATING A FRAMEWORK FOR
NIH FRAMEWORK?
>> THERE'S LIKE 50+ LAWS THAT
RELATE.
>> IT'S A GREAT QUESTION.
MANY DEFINITIONS AND STATUTES.
SO IF YOU LOOK AT THE RFI FOR
THE FRAMEWORK WE USE ADA
DEFINITION TO SET THE STAGE
BECAUSE WE'RE COMING AT THIS
THAT DISABILITY IS ONE THING,
THIS IS RESEARCH FOR ALL PEOPLE
WITH DISABILITIES, AND SO
WHETHER OR NOT ACCORDING TO THE
ADA DEFINITION YOU HAVE A
DISABILITY OR ARE PERCEIVED YOU
MAY EXPERIENCE JUST BY BEING
PERCEIVED.
IT'S ONE THING WE'LL GET ON
FURTHER, WHERE DO YOU COME DOWN
ON THIS BECAUSE IT'S
COMPLICATED.
>> WE'RE GOING TO LAND THIS
PLANE AT 3:45.
KEVIN, YOU GOT THE LAST WORD.
>> I WANTED TO HIGHLIGHT ONE
INITIATIVE WE'VE LAUNCHED WITH
ASSISTANCE OF OFFICE OF HUMAN
RESOURCES.
THAT IS, WHEN WE ISSUE TENTATIVE
OFFERS TO EMPLOYEES WHO WILL BE
JOINING THE NIH, ONE OF THE
THINGS THAT WE'VE NOW DONE IS
ASKED THEM IF THERE'S A NEED FOR
REASONABLE ACCOMMODATION.
AND SO THAT WAY WHEN THEY SHOW
UP TO THE AGENCY ON DAY 1, THE
ACCOMMODATION IS AVAILABLE, IT'S
SITTING THERE WAITING FOR THEM,
SO THEY DO NOT ON-BOARD AT NIH
AND WAIT ONE, TWO, THREE WEEKS
FOR AN ACCOMMODATION TO SHOW UP.
WE BELIEVE WE'RE FOSTERING AND
DRIVING INCLUSION FOR COLLEAGUES
THAT MAY HAVE DISABILITIES.
>> THANK YOU, EVERYBODY.
>> YEAH, THANK YOU SO MUCH.
OKAY.
NOW WE'RE GOING TO MOVE ON TO A
DISCUSSION FROM DR. LYRIC
JORGENSON OF NExTRAC ENGAGE.
SHE'S ASSOCIATE DIRECTOR FOR
SCIENCE POLICY AT NIH.
>> THANK YOU SO MUCH.
I'M LYRIC, AS YOU'VE HEARD
THROUGHOUT INCLUSIVE ENGAGEMENT
EMBEDDED IN THE WORK WE'RE DOING
AT NIH HOLDS TRUE FOR POLICY
TEAM THINKING ABOUT POLICY
CONCEPTION, DEVELOPMENT,
IMPLEMENTATION AND EVALUATION.
I'M DELIGHTED TO SHARE UPDATES
ON ONGOING WORK UNDER THE ENGAGE
INITIATIVE WHICH IS REFLECTIVE
OF THE WORK OF MANY, MANY, MANY
FOLKS ACROSS NIH AND THE
COUNTRY.
I'M HONORED TO REPRESENT THIS
WORK TODAY.
NEXT SLIDE PLEASE.
BEFORE WE DIVE IN I'D LIKE TO
REMIND THE ACD AND THOSE ONLINE
OF THE CONTEXT FOR TODAY'S
PRESENTATION.
YOU MAY RECALL BACK IN AUGUST OF
2023 THEN ACTING NIH DIRECTOR
LARRY TABAK CHARGED THE NOVEL
AND EXCEPTIONAL TECHNOLOGIES
RESEARCH ADVISORY COMMITTEE,
AGAIN THE NExTRAC, TO DEVELOP
VISION AND FRAMEWORK FOR PUBLIC
VOICES IN NIH-FUNDED CLINICAL
TRIALS.
GIVEN THE IMPORTANCE BEING
BROADLY INCLUSIVE AND NEEDING
INPUT FROM MULTIPLE PEOPLE
AROUND THE COUNTRY, MULTIPLE
ROLES, WE MADE SURE THE GROUP'S
WORK WAS BROUGHT TO THE ACD'S
ATTENTION FOR DISCUSSION AND
INPUT ALONG THE WAY.
YOU HEARD FROM THE NExTRAC
WORKING GROUP CHAIRS SUE AND
CHRIS IN DECEMBER REGARDING
PROGRESS AND HOW THEY PLANNED TO
TACKLE THIS CHARGE.
IN JUNE OF THIS YEAR NIH CREATED
A CENTRAL SPACE FOR ENGAGE
EFFORT AND PRODUCT AS WELL AS
FRONT DOOR FOR REFLECTING NIH
EXPERTISE AND WORKING COMMUNITY
ENGAGEMENT.
WHICH BRINGS US TO THE LAST
COUPLE WEEKS WHERE THE WORKING
GROUP IS SHARING PROGRESS WITH
THE NExTRAC AT A MEETING LAST
WEEK AND ME HERE WITH YOU ALL
TODAY.
NEXT SLIDE PLEASE.
SO NOW LET'S DIVE IN.
I WANT TO BE REALLY CLEAR I'M
REPRESENTING THE WORK OF ALL OF
THESE AMAZING TALENTED FOLKS,
THE ENGAGE WORKING GROUP AND
NExTRAC AND A TEAM OF EXPERTS
AT NIH.
IN THE SPIRIT OF THE WORK THAT
NEEDS TO BE DONE TO ENGAGE THE
BROAD AND DIVERSE VOICES ACROSS
THE COUNTRY IN CLINICAL RESEARCH
AS I MENTIONED THE NIH CHARGED
THE NExTRAC WITH DEVELOPING
THIS FRAMEWORK FOR INCLUDING
PUBLIC VOICES THROUGHOUT THE
CLINICAL RESEARCH LIFE CYCLE.
SPECIFICALLY THE FRAMEWORK
SHOULD THINK ABOUT APPROACHES
FOR THE BREADTH AND DIVERSITY OF
NIH-FUNDED CLINICAL RESEARCH
STUDIES, ASSESS OPPORTUNITIES
AND CHALLENGES OF LEVELS OF
ENGAGEMENT ACTIVITIES FOR THE
RESEARCH STUDIES.
IMPORTANTLY TO ENSURE ANY VISION
IS ANCHORED IN INSTITUTIONAL
PRACTICES, AND REALITIES,
CHALLENGES OF ACTUAL ENGAGEMENT,
WE ASKED THE NExTRAC AND ACD
TO THINK THROUGH RECOMMENDATIONS
REGARDING HOW ENGAGEMENT METHODS
COULD BE USED, OPTIMAL TIMING
FOR MEANINGFUL ENGAGEMENT
ACTIVITIES, AND ANY APPROACHES
CONSIDERED THROUGH THE LENS OF
INCLUSIVITY AND EQUITABILITY.
WE HAVE TWO EXCELLENT CO-CHAIRS
LEADING OUR EXTERNAL EFFORTS,
FIRST ALUMNI PROFESSOR OF SCHOOL
OF NURSING AND PROFESSOR OF
BIOMEDICAL INFORMATICS AT
COLUMBIA UNIVERSITY.
EXTENSIVE EXPERIENCE WITH
PATIENT ENGAGEMENT AND RESEARCH,
SPECIFICALLY THROUGH LENS OF
PROMOTING HEALTH AND REDUCING
HEALTH DISPARITIES.
NEXT WE HAVE A TREMENDOUSLY
INFLUENTIAL PATIENT ADVOCATE,
MS. VEASLEY AS SECOND CO-CHAIR,
CO-FOUNDER AND DIRECTOR OF
CHRONIC PAIN RESEARCH ALLIANCE,
HOLDS ADVISORY COMMISSIONS FOR
PAIN INITIATIVES IN FEDERAL
AGENCIES, ACADEMIC PAIN RESEARCH
STUDIES, VARIOUS COLLABORATIVE
ALLIANCES.
SHE'S BEEN AN ADVOCATE AT
CONGRESSIONAL AND FEDERAL AGENCY
LEVEL FOR BRINGING ABOUT PUBLIC
AWARENESS OF THE PROFOUND IMPACT
OF CHRONIC PAIN.
WE ALSO HAVE 21 OTHER WORKING
GROUP MEMBERS, I CAN TELL YOU
THIS IS ONE OF THE LARGEST I'VE
SEEN IN A LONG TIME, BECAUSE
THEY ARE ALL ENERGIZED AND READY
TO CHANGE THE WORLD.
THIS INCLUDES PATIENTS AND
PATIENT ADVOCATES REPRESENTING
AREAS IN CANCER, RARE DISEASE,
SICKLE CELL DISEASE, DOWN
SYNDROME, AND MORE AND
PERSPECTIVES HAVE BEEN
ESSENTIAL.
WE HAVE ACADEMICS, FROM
RESEARCH, RURAL HEALTH, TRIBAL
HEALTH, AND MORE AND
REPRESENTATION FROM NON-PROFIT
ORGANIZATIONS ACTIVE IN THE
SPACE, IMPORTANT PARTNERS AS WE
MOVE FORWARD.
WE'RE ALSO THRILLED TO HAVE
CURRENT ACD MEMBER AND RECENT
MEMBER ON THE GROUP.
I'LL TURN TO ALEXA AT THE END
FOR HER REFLECTIONS.
NEXT SLIDE PLEASE.
NOW AS WE SHARE SLIDES PRESENTED
AT THE MOST RECENT NExTRAC
MEETING I'M HONORED TO REFLECT
THEM TODAY.
THEY HAVE MADE SIGNIFICANT
PROGRESS DURING THEIR FIRST YEAR
AND ARE ON TRACK TO DELIVER THE
FINAL REPORT AND RECOMMENDATIONS
IN THE SUMMER OF 2025.
THEY DID MEET LAST WEEK IN A
PUBLIC CONVENING AND HEARD THIS
READOUT.
I HIGHLIGHT SLIDES ARE NOT MINE.
YOU CAN SEE THE PRESENTATION ON
THE PUBLIC WEBCAST.
SOME WORKING GROUPS
ACCOMPLISHMENTS INCLUDE FIRST
DEFINING DEFINITION FOR WHAT WE
MEAN BY CLINICAL RESEARCH
ENGAGEMENT, IDENTIFYING KEY
PLAYERS IN THE PROCESS.
THEY HAVE DEVELOPED A WORKING
FRAMEWORK GRAPHIC THAT SERVES AS
A ROAD MAP FOR INCLUDING
OBJECTIVES AND DOMAINS FOR
INCLUSIVE ENGAGEMENT.
AGAIN, THE GOAL TORE THIS TO BE
ROAD MAP FOR A MEANINGFUL
PROCESS.
FINALLY A TOOLBOX OF RESOURCES
TO SUPPORT CLINICAL RESEARCH
ENGAGEMENT TO SERVE AS A MODEL
AS WE LEARN MORE AND BRING MORE
PEOPLE TO THE TABLE.
SO I'LL TALK ABOUT THE THREE
EFFORTS BRIEFLY IN THE NEXT FEW
SLIDES.
NEXT SLIDE PLEASE.
FIRST THE WORKING GROUP
DETERMINES COMMUNITY ENGAGEMENT
IS LIKE A PROBLEM OF MANY PEOPLE
TOUCHING VARIOUS PARTS OF AN
ELEPHANT, A CLEAR DEFINITION OF
WHAT WE'RE TRYING TO ACHIEVE
ENGAGEMENT IS NEEDED.
ENGAGEMENT IS INVOLVEMENT THAT
VARIES BY LEVEL AND TYPE,
DEPENDING ON RESEARCH AND
COMMUNITY NEEDS.
WITH INDIVIDUALS, GROUPS OF
PEOPLE, COMMUNITIES, AND/OR
ORGANIZATIONS ACROSS THE VARIOUS
STAGES OF CLINICAL RESEARCH SO
THE RESEARCH AND OUTCOMES ARE
MEANINGFUL AND ACTIONABLE TO ITS
RELEVANT PARTNERS.
THIS IS INTENTIONALLY A BROAD
AND INCLUSIVE DEFINITION THAT'S
INTENDED TO ENCOMPASS NUMEROUS
STUDY DESIGNS, CLINICAL TRIALS
AND TRANSLATIONAL RESEARCH.
TO HELP UNPACK SOME KEY CONCEPTS
WITHIN THIS DEFINITION THE
WORKING GROUP HAS DEVELOPED TWO
SUPPORTING FIGURES.
FIRST, WHAT WE MEAN BY THE
VARIOUS STAGES OF CLINICAL
RESEARCH.
AND SECOND, THE RELEVANT
PARTNERS IN ENGAGEMENT.
AGAIN, THESE ARE MEANT TO BE
ILLUSTRATIVE AN NON-EXHAUSTIVE.
RESOURCES EXIST, TO BE ABLE TO
ASSESS GAPS AND BARRIERS.
AND ENGAGE THOSE TRADITIONALLY
UNREPRESENTED IN RESEARCH TO
DETERMINE WHAT OTHER
INFRASTRUCTURE AND TOOLS ARE
NEEDED TO FORGE A PATH FORWARD.
NEXT SLIDE PLEASE.
SO THE WORKING GROUP HAS BEEN
HARD AT WORK IN DEVELOPING THEIR
CONCEPT OF A FRAMEWORK FOR
CLINICAL RESEARCH ENGAGEMENT.
THEY ENVISION A ROAD MAP
SUITABLE FOR A BROAD AUDIENCE,
IT WILL DELIVER OUTCOMES TO
ENHANCE TRUST, PARTNERSHIP,
AGENCY.
WE'RE WORKING ON ILLUSTRATIONS
TO SIMPLIFY AT SOME LEVEL BUT
WITHIN THE FRAMEWORK THERE ARE
ACTIONABLE ELEMENTS DESIGNED
WITH INTENT OF ENABLING
INDIVIDUALS USING IT TO CLEARLY
IDENTIFY CONCRETE STEPS THEY CAN
TAPE TO IMPROVE PUBLIC
ENGAGEMENT IN RESEARCH.
AGAIN, THE GOAL FOR INTENDED
USER TO FIND WHERE THEY FIT INTO
THE CYCLE AND GIVE THEM TOOLS
FOR ENGAGING.
IT IS COMPLEMENTED BY MATURITY
MODEL, INTENDED TO SERVE AS
BASELINE ENTRY POINT FOR
MEANINGFUL ENGAGEMENT WITH ROAD
MAP FOR INCREASING ENGAGEMENT
COMPLEXITY AND INTENSITY OVER
TIME.
AS MENTIONED IT'S STILL BEING
ITERATED UPON THROUGH A PROCESS
I'LL DESCRIBE.
THIS IS THE ORIGINAL CONCEPT
GRAPHIC FRAMEWORK THAT WAS
PRESENTED.
IT IS ITERATED AND DEVELOPED
OVER TIME BUT AGAIN WANTED TO
SHOW YOU HOW THE GROUP IS
APPROACHING THE TASK.
I WON'T GO INTO DETAIL BUT YOU
SEE RESEARCH LIFE CYCLE,
ENTITIES WITH A ROLE TO PLAY IN
SUCCESS ALSO DEFINED AROUND
CIRCLES.
YOU CAN SEE FACTORS THAT AFFECT
BROADER ENTERPRISE,
CONTEXTUALIZING WHERE RESEARCH
HAPPENS AS YOU HEARD TODAY FROM
LEADERSHIP AND MEETING PEOPLE
WHERE THEY ARE IN COMMUNITIES
AND STUDIES WHERE THE WORK IS
OCCURRING.
THE NEED TO MITIGATE SOCIAL
DETERMINANTS OF HEALTH THROUGH
INFRASTRUCTURE AND CAPACITY
BUILDING.
THOSE ARE THE EXTERNAL
PARAMETERS AROUND THE FRAMEWORK.
NEXT SLIDE PLEASE.
YOU SAW PART OF THE RESEARCH
LIFE CYCLE, THE WORKING GROUP
IS
UNPACKING TO LAY OUT OBJECTIVES
AND DOMAINS FOR THE LIFE CYCLE
WITH THE GOAL TO PROVIDE
TANGIBLE ACTION ORIENTED STEPS
THAT COULD BE IMPLEMENTED BY
USERS.
WORK CONTINUES TO BE DEVELOPED.
YOU WILL SEE BRIEFLY THAT DRAFT
OBJECTIVES IN TERMS OF RESEARCH
QUESTION, RESEARCH STUDIES
INFORMED AND DRIVEN BY COMMUNITY
HEALTH NEEDS AND PRIORITIES.
YOU ALSO SEE DRAFT OBJECTIVE FOR
AGENDA SETTING SHARED EQUITABLE
PRIORITY SETTING PROCESS FOR
COMMUNITY NEEDS MATCHED TO
RESEARCH QUESTIONS AND AGAIN
WE'VE HEARD ABOUT THIS TODAY IN
TERMS OF CARE FOR HEALTH
INITIATIVE.
DRAFT OBJECTIVE FOR DESIGN
PLANNING TO MAKE SURE RESEARCH
QUESTIONS OR RESEARCH STUDY IS
CO-DESIGNED WITH COMMUNITY
MEMBERS.
NEXT SLIDE PLEASE.
FINALLY A TOOLBOX WOULD
COMPLEMENT THE FRAMEWORK TO
SUPPORT MEANINGFUL PUBLIC
ENGAGEMENT AND CLINICAL
RESEARCH.
THE TOOLBOX RIGHT NOW IS A
STARTING POINT FOR IDENTIFYING
RELEVANT RESOURCES, AGAIN THE
WORLD HAS BEEN PLAYING IN THIS
SPACE FOR A DECENT AMOUNT OF
TIME, WE WANT TO BUILD ON THAT
EXPERIENCE.
THE GROUP IS WORKING TO ASSEMBLE
TOOLS TO HELP BOTH RESEARCHERS
AND COMMUNITIES TO ENACT
MEANINGFUL ENGAGEMENT.
THE GROUP IS WORKING ON
ORGANIZATIONAL TAGGING SYSTEM
FOR THESE RESOURCES THAT ALIGNS
WITH THE FRAMEWORK SO IT CAN
IMPROVE SEARCHING AND INDEXING
IN FUTURE ITERATIONS, INCLUDING
USERS OF THE RESOURCE, ARE YOU A
COMMUNITY MEMBER OR RESEARCH?
WHO IS INTENDED AUDIENCE OF THE
RESOURCE?
AGAIN, WHO ARE YOU INTENDING TO
AFFECT?
WHERE IN THE CLINICAL RESEARCH
LIFE CYCLE YOU ARE IN STARTING
TO PLAN YOUR STUDY OR
DISSEMINATING RESULTS?
RESEARCH WOULD BE USED AS
SUPPORT, IN TERMS OF NOVEL OR
EMERGING TECHNOLOGIES, AGAIN
BRINGING NEW CONCEPTS TO
COMMUNITIES AND HOW TO WORK WITH
THEM ON EMERGING AND UNKNOWN
INTERVENTIONS.
NEXT SLIDE PLEASE.
AS WE'VE BEEN DISCUSSING AGAIN
TODAY, THE KEY TO ENGAGE
FUNCTIONING IS UNDERSTANDING HOW
PEOPLE WANT TO BE ENGAGED, AND
WHAT ARE STRATEGIES FOR DOING
SO.
IN SUPPORT OF THE ENGAGE EFFORT,
NIH HAS BEEN SEEKING PUBLIC
INPUT FOR MULTIPLE CHALLENGES TO
ASSIST WORKING GROUP IN MEETING
THEIR CHARGE.
THESE CHANNELS INCLUDE BASELINE
REQUESTS FOR INFORMATION AGAIN
GETTING THE WORD OUT TO EVERYONE
SO THEY CAN PARTICIPATE IN THE
PROCESS.
WE'VE ALSO WORKED WITH COMMUNITY
GROUPS TO HAVE LISTENING
SESSIONS, AND WE'RE HAVING 12
CONVERSATIONS WITH COMMUNITIES
ACROSS THE COUNTRY TO SEEK
PERSPECTIVES ON DIFFERENT
ENGAGEMENT METHODS, OPTIMAL
TIMING FOR ACTIVITIES AND HOW TO
APPROACH ENGAGEMENT TO ENSURE IT
IS EQUITY AND INCLUSIVE.
NEXT SLIDE PLEASE.
THE FIRST AVENUE WAS REQUEST FOR
PUBLIC INPUT THROUGH REQUEST FOR
INFORMATION IN VIRTUAL LISTENING
SESSION.
REQUEST FOR INFORMATION RECEIVED
51 COMMENTS, VIRTUAL LISTENING
SESSION HAD TEN MEMBERS OF THE
PUBLIC PROVIDE ORAL COMMENTS AND
ONE INDIVIDUAL COMMENTED IN
WRITTEN FORMAT.
REQUEST FOR INFORMATION HAD FIVE
AREAS WHICH NIH WAS SEEKING
INDIVIDUAL PUBLIC INPUT ON A
RANGE OF ISSUES.
RESPONSES WERE REALLY, REALLY
THOUGHTFUL.
TACKLING STRATEGIES FOR WORKING
WITH COMMUNITIES, RESOURCES AND
NEEDS FOR INSTITUTIONAL AND
FINANCIAL SUPPORT IN TERMS OF
SUPPORTING ENGAGEMENT, BARRIERS
FOR COMMUNITIES TO NAME A FEW.
I WON'T DIVE INTO A DEEP
ANALYSIS HERE REGARDING THE
COMMENTS BUT I WOULD LIKE TO
HIGHLIGHT SOME OF THE BIG
PICTURE FINDINGS TO DATE.
NEXT SLIDE PLEASE.
SO FAR WE'VE SEEN A STRONG
BELIEF RESEARCHERS SHOULD
INCORPORATE COMMUNITY INPUT
INCLUDING PART PARTNERING WITH
THE COMMUNITY, IDENTIFYING
COMMUNITY PRIORITIES, SOLICITING
COMMUNITY INPUT ON THE RESEARCH.
SECOND, THERE'S A STRONG
IMPORTANCE REQUIRING
NON-FINANCIAL INCENTIVES AND
COMPENSATION FOR ENGAGEMENT
ACTIVITIES.
COMPENSATION SHOULD BE SPARE AND
MEASURED WITH RESPONSIBILITIES.
AGAIN PARTICIPANTS IN RESEARCH,
WHETHER PROVIDING INPUT OR
STRATEGY REALLY SHOULD BE
COMPENSATED FOR EXPERTISE WITH
LIVED EXPERIENCES.
RESPONDENTS HIGHLIGHTED
CONSIDERING INCENTIVES LIKE
DURABLE MEDICAL EQUIPMENT OR
REINVESTMENT INTO THE COMMUNITY
THROUGH SUSTAINABLE
INFRASTRUCTURE OR RETURN OF
RESEARCH RESULTS.
VARIABLE INFRASTRUCTURE KNOW-HOW
AND RESOURCES TO INVEST IN
ACQUIRING THESE TOOLS ARE KEY
BARRIERS TO ACHIEVING MEANINGFUL
COMMUNITY ENGAGEMENT, SOMETHING
WE NEED TO TACKLE.
NEXT SLIDE PLEASE.
SO IN SUPPORT OF ENGAGE
INITIATIVE NIH LARGELY THROUGH
OFFICE OF SCIENCE POLICY HAS
TAKEN THIS EFFORT ON THE ROAD.
WE WORKED TO HEAR FROM COMMUNITY
ON THE GROUND, TO MAKE THIS
EFFORT A SUCCESS AND PROVIDE
SUSTAINABILITY.
WE'RE GRATEFUL TO ESTABLISH A
PARTNERSHIP WITH LEADING EXPERTS
IN COMMUNITY ENGAGEMENT TO HELP
FACILITATE HOPE AND HONEST
CONVERSATION IN COMMUNITIES THAT
STARTED IN OCTOBER AND WILL
CONCLUDE IN FEBRUARY OF 2025.
YOU'LL SEE A PICTURE OF THE
PLACES WE HAVE BEEN OR PLAN TO
GO, HELD IN PERSON AND
COMMUNITIES ACROSS THE COUNTRY,
THEY SPAN RURAL AND URBAN
COMMUNITIES, AMERICAN INDIAN AND
ALASKA NATIVES AND MORE.
TOMORROW AT THE FLINT MICHIGAN
PUBLIC LIBRARY.
I WILL JUST SAY THAT THE
APPROACH HERE TO THE
CONVERSATIONS HAS BEEN CRITICAL
TO THEIR SUCCESS.
A LOT OF WORK GOES INTO HAVING
CONVERSATIONS TO ENSURE THEY ARE
MEANINGFUL AND RECEIVE
BIDIRECTIONAL ENGAGEMENT.
NExTRAC MEMBERS WORK WITH
ENGAGEMENT SPECIALISTS TO FIRST
IDENTIFY A TRUSTED COMMUNITY
PARTNER TO ASSIST IN PLANNING
AND HOSTING THE EVENTS.
THIS IS FINDING PEOPLE ON THE
GROUPED WHO -- GROUND TO
FACILITATE.
WE DEVELOP A GUIDE THAT INCLUDES
CRITICAL TOPICS INCLUDING
PRIMERS ON CLINICAL RESEARCH,
QUESTIONS ABOUT HOW TO
UNDERSTAND THE VALUE FOR
COMMUNITIES.
WE ALSO INCLUDE QUESTIONNAIRE TO
COLLECT MORE INFORMATION ABOUT
THESE COMMUNITIES AND
FAMILIARITY WITH SOME TOPICS
WE'LL BE DISCUSSING SO WE CAN
ENGAGE AT THE RIGHT LEVEL.
DURING THE CONVERSATIONS BETWEEN
25 AND 30 INDIVIDUALS ATTEND A
THREE-HOUR CONVERSATION,
INCLUDING SMALL AND LARGE GROUP
DISCUSSIONS.
YOU CAN SEE PHOTOS OF THE EVENTS
IN IDAHO FALLS WHICH I WAS LUCKY
ENOUGH TO ATTEND LAST MONTH.
EACH CONVERSATION HAS A LIVE
ILLUSTRATOR PRESENT ON ZOOM
CAPTURING A VISUAL DEPICTION OF
THE MAIN TOPICS.
THE ILLUSTRATION UPDATED OVER
THE COURSE OF THE CONVERSATION,
SEEN IN REAL TIME.
AFTER THE CONVERSATION EACH
ATTENDEE AND HOST RECEIVE A
THANK YOU E-MAIL PROVIDING
INFORMATION HOW TO STAY UP TO
DATE ON THE COMMUNITY
CONVERSATION PROCESS, THE
NExTRAC ENGAGEMENT, AND WHEN
HELPFUL SOME ADDITIONAL
RESOURCES THAT NIH SHARES ON
WHAT IS IDENTIFIED IN THE
CONVERSATIONS.
NEXT SLIDE PLEASE.
HERE'S JUST A LARGER
REPRESENTATION OF ONE OF THE
VISUAL GRAPHICS, WHICH IS
FEATURED ON OUR ENGAGE WEBSITE.
EACH HAS A SECTION DEDICATED TO
COMMUNITY CONVERSATIONS, FOR
EACH CONVERSATION THE FLYER,
MATERIAL PRESENTED DURING THE
MEETING, ILLUSTRATION, AND A
SUMMARY REPORT ARE POSTED.
ILLUSTRATION DEVELOPED HERE IN
IDAHO FALLS IS ON THE SITE, THE
COMMUNITY CAN USE IT TO COMPARE
TO SEE WHERE THEY SHARE VALUES,
EXPECTATIONS, AND HAVE UNIQUE
DIFFERENCES.
IT ALLOWS COMMUNITIES TO SEE HOW
THE NExTRAC PRODUCTS ARE
DEVELOPING IN REAL TIME AND HOW
IT EVOLVES BASED ON FEEDBACK
FROM THAT CONVERSATION.
NEXT SLIDE PLEASE.
SO SHIFTING GEARS A BIT IT'S
CRITICAL THE COMMUNITY KNOW NIH
IS SERIOUS ABOUT TURNING
FEEDBACK INTO ACTION.
A LOT OF CONVERSATIONS WE HEARD
TODAY DEMONSTRATE THAT'S INDEED
THE CASE.
ACCORDINGLY WE'RE REALLY
THINKING ABOUT THE LANDING PAD
FOR ENGAGE INITIATIVE EFFORTS,
FOR RECOMMENDATIONS AS WELL AS
MOBILIZING EXPERTS WORKING HARD
ON THESE TOPICS TO RESPOND TO
THE NEXT PHASE OF
IMPLEMENTATION.
NOW I'M DELIGHTED TO REPRESENT
THE WORK OF THE DIFFERENT GROUP,
COMMUNITY ENGAGEMENT EXPERTS
ACROSS NIH INSTITUTES AND
CENTERS, MOBILIZING THEIR
EXPERIENCE AND THE
INFRASTRUCTURE AT NIH TO TAKE
RECOMMENDATIONS AND RUN WHEN
THEY LAND IN THE SUMMER.
NEXT SLIDE PLEASE.
BEFORE I TALK ABOUT THEIR
PROGRESS I WANTED TO REMIND
EVERYONE NIH REALLY DOES HAVE
VAST EXPERIENCES IN THIS DOMAIN,
ACROSS MANY PERHAPS. -- PROGRAM.
WE HAVE A TON OF MOTIVATED FOLKS
THINKING ABOUT THIS TOPIC EVERY
DAY.
OUR GOAL WAS TO COALESCE
EXPERTISE INTO A COMMUNITY OF
PRACTICE THAT COULD SHARE
LESSONS AND BUILD A STRONGER
TEAM.
OVER SIX MONTHS THESE EXPERTS
HAVE BEEN CONVENING EVERY OTHER
WEEK TO DO JUST THAT.
I'M HAPPY TO SHARE A FEW
SNAPSHOTS OF THE PROGRESS.
NEXT SLIDE PLEASE.
FIRST NIH HAS ESTABLISHED A
CENTER FOR EFFORTS, THIS IS SO
BROAD ACROSS THE AGENCY, IT
WON'T HOUSE EVERYTHING WE DO BUT
IT DOES PROVIDE A SNAPSHOT OF
HOW TO ENTER INTO ENGAGE
INITIATIVE AND CONNECT ACROSS
THE AGENCY, PARTNERS IN RESEARCH
INCLUDES ENGAGE WORK, WELCOME
FROM NIH DIRECTOR, INFORMATION
ABOUT THE ONGOING COMMUNITY
CONVERSATIONS.
NEXT SLIDE PLEASE.
THIS WEBSITE IS BEING BUILT OUT
TO TAKE IN THE SHARED KNOWLEDGE
ACROSS THE INSTITUTES AND
CENTERS ON THE FRONT LINES OF
PIONEERING THIS WORK.
WE'RE TRYING TO MAKE THEIR WORK
VISIBLE FOR ALL TO LEARN AND
IMPLEMENT.
YOU'LL SEE A SET OF CASE STUDIES
DEVELOPED BY OUR INTERNAL NIH
EXPERTS REFLECTING EXPERIENCES
IN THEIR INSTITUTES OF HOW THEY
PUT THESE PLANS INTO ACTION.
THESE CASE STUDIES WERE
DEVELOPED FROM BEST PRACTICE
EXAMPLES FROM THE VARIOUS
PROGRAMS AND REFLECT DIFFERENT
TIMES OF ENGAGEMENT, AND
COMMUNITIES ACROSS POPULATIONS
WITH UNIQUE NEEDS.
WE EXPECT THIS TO BE A LIVING
RESOURCE OVER TIME, THE
COMMUNITY OF PRACTICE HAS
REALLY, REALLY BEEN CRITICAL TO
ITS SUCCESS.
NEXT SLIDE PLEASE.
AGAIN, I'M HERE REPRESENTING OF
THE WORK THAT DOVETAILS WITH
PRIORITIES DISCUSSED HERE TODAY.
THE WORK IS TRYING TO MEET
PEOPLE WHERE THEY ARE, THIS IS
PART OF THE KEY OF SUCCESSFUL
ENGAGEMENT.
WE EXPECT OVER THE NEXT EIGHT TO
NINE MONTHS THE WORKING GROUP
WILL CONTINUE TO WORK ON THE
FRAMEWORK AND TOOLBOX AND MOVE
FORWARD TO FINAL RECOMMENDATIONS
TO NIH.
THE NExTRAC DID DISCUSS THIS
WORK LAST WEEK, THEIR
CONVERSATIONS CAN BE VIEWED ON
VIDEOCAST, ENERGIZED TURNING
THIS INTO A REALITY.
NEXT SLIDE PLEASE.
BEFORE I CLOSE AND TURN TO
DISCUSSION I DO WANT TO
HIGHLIGHT HIGH LEVEL
OBSERVATIONS TO DATE.
FIRST THE IMPORTANCE OF
CULTIVATING TRUST-BASED
RELATIONSHIPS, WITH COMMUNITY
LEADERS AND INSTITUTIONS, REALLY
RELYING ON TRUSTED COMMUNITY
VOICES THAT WOULD BE COMMUNITY
LEADERS AND INSTITUTIONS WORKING
ON THE FRONT LINES, CRITICAL AND
OVERCOMING DISTRESS AND
SKEPTICISM.
LESSONS WERE BROUGHT INTO FOCUS
DURING THE COVID SPANNED WITH
CEAL PROVIDING EXAMPLES.
ENGAGEMENT IS BIDIRECTIONAL.
COMMUNITIES ARE JUST AS
INTERESTED IN UNDERSTANDING
RESEARCHERS AS RESEARCHERS ARE
INTERESTED IN LEARNING ABOUT
COMMUNITIES.
IT IS IMPERATIVE WE DEVELOP
RELEVANT MATERIALS AND
FACILITATE CONVERSATIONS WITH
OPEN MIND, RESPECT, CULTURAL
HUMILITY.
AND THREE, COMMUNITIES SHOULD BE
CENTRAL IN RESEARCH AND INVOLVED
IN DESIGN AND PLANNING, NEW
PROGRAMS ARE ALREADY UNDERWAY
MAKING GROUNDBREAKING STRIDES
TURNING INTO WHAT COMMUNITIES
WANT TO LEARN ABOUT THEMSELVES
WITH A RESEARCH FOCUS.
FINALLY SCIENCE AND SOCIETY WILL
CONTINUE TO EVOLVE, SOLVING THE
MOST PRESSING HEALTH PROBLEMS
WILL REQUIRE BRINGING PEOPLE
ALONG THE JOURNEY AND NOT JUST
TELLING THEM DESTINATION.
WE NEED TO MEET FOLKS WHERE THEY
ARE TO BUILD TRUSTS WITH
PARTNERSHIPS, KEY TO MOVING
FORWARD.
I WOULD LOVE TO TURN TO ALEXA TO
REFLECT ON WORK.
>> CAN YOU HEAR ME?
>> YES.
>> SO I HAVE TO SAY THIS IS ONE
OF THE MOST EXTRAORDINARY
PROJECTS I'VE BEEN PART OF.
IT IS MAMMOTH IN SCOPE,
THOUGHTFUL, REALLY
SCIENTIFICALLY CONSTRUCTED TO
BRING THE BEST THAT WE CAN
AROUND SOCIAL SCIENCE
ENGAGEMENT, COMMUNITY
PARTNERSHIP AND DATA TO BUILD
THIS FORWARD, IN ADDITION TO AN
ENORMOUS AMOUNT OF COMMUNITY
ENGAGEMENT.
AS YOU HEARD FROM LYRIC WE'VE
ITERATED BASED ON COMMUNITY
FEEDBACK WHERE OUR FRAMEWORKS
ARE TOO COMPLICATED TO DIGEST OR
THEY AREN'T POSITIONING THE
COMMUNITY IN A WAY THAT IS
COMPELLING, SO IT IS REALLY BEEN
AN AMAZING GROUP.
A HUGE CREDIT TO THE PEOPLE WHO
SYNTHESIZE ALL THIS INFORMATION
AND THAT ARE BRINGING IT INTO
THE WHOLE.
SO KUDOS TO THE TEAM.
IT'S BEEN GREAT.
>> PULL DOWN THE SLIDES.
>> THANK YOU.
IF WE COULD PULL THE SLIDES AND
SEE WHO WANTS TO COMMENT OR HAVE
HAS QUESTIONS.
>> YES, RUSS?
>> ONE QUESTION ABOUT THE
VISION FOR SORT OF WHERE THE
RUBBER MEETS THE ROAD AT THE END
OF THIS.
I COULD ENVISION A PROCESS WHERE
ANY RFI COMING OUT FROM AN
INSTITUTE OR CENTER WOULD NEED
TO GO THROUGH A COMMUNITY
VETTING PROCESS TO ENSURE THAT
IT'S MEETING THE NEEDS OF THE
COMMUNITY AND THE COMMUNITY HAS
HAD OPPORTUNITY FOR INPUT IN
THAT REQUEST.
I COULD ALSO ENVISION A
SITUATION WHERE IT'S SORT OF A
REQUIREMENT FOR SUBMITTING AN
RPG THAT THERE'S BEEN SOME SORT
OF COMMUNITY VETTING OR AT LEAST
DISCUSSION PROCESS.
WHAT IS SORT OF THE -- AT LEAST
THE NIH LEADERSHIP LEVEL
ANTICIPATED IMPLEMENTATION OF
THIS TO ENSURE THAT THIS ISN'T
JUST A ONE-OFF LISTENING TOUR
AND TURNS INTO SOME WAY TO HELP
SHAPE PRIORITIES GOING FORWARD.
>> YEAH, HAPPY TO START.
ONE OF THE THINGS WE REALLY
WANTED, THE GROUP WAS REFERRING
TO IT AS A TOOLBOX, I REFER TO
IT AS A MENU.
IT'S NOT A ONE-SIZE-FITS-ALL
APPROACH.
NIH RESEARCH PORTFOLIO BASIC
THROUGH CLINICAL AND
TRANSLATIONAL IS VERY DIVERSE
AND MILD BENEFIT FROM DIFFERENT
ENGAGEMENT METHODS.
THE GROUP IS LOOKING AT WHEN IS
THE BEST TIME TO PUT ENGAGEMENT
INTO PRACTICE, AT WHAT LEVEL,
WHAT SCALE IS IT MOST WARRANTE.
YOU'LL HEAR I LOVE TO
UNDERSTAND, OTHERS ARE SAYING
I'M REALLY BUSY, HERE IS WHERE I
WANT TO HEAR THE CONVERSATION.
WE WANT TO HAVE AN
EVIDENCE-BASED PORTFOLIO
STRATEGY THAT WORKS BASED ON
WHAT TRYING TO ACHIEVE.
>> I'LL JUST ADD THERE ARE SOME
INITIATIVES THAT WE DO WHERE
THIS IS CLEARLY BAKED IN FROM
THE VERY BEGINNING.
ONE, CARE FOR HEALTH INITIATIVE.
ANOTHER, RECOVER, AND RECOVER
T.L.C. OBVIOUSLY FUNDAMENTAL
COMPONENTS OF THOSE ACTIVITIES.
YOU CAN IMAGINE THOUGH THESE
KINDS OF EFFORTS OR SMALL PARTS,
NOT ALL, MIGHT BE APPLIED TO
MANY OTHER THINGS.
SO YOU USE THE WORD "REQUIRE," I
MEAN, I DON'T THINK WE'RE THERE
WITH THIS.
I THINK WHERE WE ARE INSTEAD IS
DEMONSTRATING NOT ONLY TO THE
PEOPLE WE SERVE BUT ALSO TO THE
RESEARCH COMMUNITY, THE
INCREDIBLE VALUE OF THIS KIND OF
APPROACH TO THE WORK AND THEN
WE'LL SEE WHERE THAT GOES.
IS THAT FAIR?
>> ABSOLUTELY.
>> GO AHEAD.
WE HAVE BRIAN AND WAFAA.
>> I JUST HAVE TO SAY I LOVE THE
VISUAL NOTE TAKING.
IT'S A GREAT WAY OF SUMMARIZING
SO I'M GLAD YOU USE THAT
APPROACH.
I APPRECIATE IT.
YOU KNOW, ONE OF THE THINGS THAT
I'VE OBSERVED IN WORKING WITH
COMMUNITY ORGANIZATIONS FOR
ABOUT 20 YEARS IS THAT OFTEN
WHEN WE CONNECT WITH COMMUNITY,
THEY ARE INTERESTED IN A LOT OF
HEALTH DOMAINS.
IF WE COME AND SAY WE WANT TO DO
A PROJECT ON HIV, IT WOULDN'T BE
UNUSUAL FOR THEM TO SAY WHAT ARE
YOU DOING ABOUT VIOLENCE,
ADDICTION, ABOUT MENTAL HEALTH,
ABOUT CARDIOVASCULAR DISEASE?
AND, YOU KNOW, THE FRAMEWORK
WE'VE TRIED TO USE IN OUR
INSTITUTE IS TO BRING
INVESTIGATORS TOGETHER ON
DIFFERENT TOPICS AND FORGE
RELATIONSHIPS WITH COMMUNITY
ORGANIZATIONS THAT INVOLVE
MULTIPLE INVESTIGATORS.
THAT'S ONE KIND OF APPROACH.
IT'S ALSO I THINK, YOU KNOW, AS
YOU SAID, MONICA, IN BIG
INITIATIVES YOU CAN BAKE IT IN.
IF IT'S A LARGE INITIATIVE WITH
MULTIPLE INVESTIGATORS A LOT OF
RESOURCES, THERE ARE SOME REAL
INHERENT CHALLENGES IN DOING IT
IN A SINGLE R01, R34, TIME
LIMITED, I JUST WONDER HOW THAT
TENSION WAS BROUGHT INTO THIS
CONVERSATION AND BECAUSE, YOU
KNOW, OBVIOUSLY THAT'S THE
MAJORITY OF NIH FUNDING IS GOING
OUT IN SINGLE INVESTIGATOR
INITIATED GRANTS, SO JUST
WONDERING HOW THAT CAME UP IN
THE CONVERSATION.
>> SO IT DEPENDS.
ARE YOU TALKING ABOUT CLINICAL
RESEARCH, LARGE, YOU KNOW,
CLINICAL RESEARCH INITIATIVES?
YOU ARE, YOU'RE SPOT ON WHY CARE
FOR HEALTH WAS DEVELOPED.
THIS IS A STANDING SUSTAINABLE
LONG-TERM INFRASTRUCTURE THAT
GOES INTO COMMUNITIES, ENGAGES
WITH THEM, TO MEET ALL OF HEALTH
NEEDS.
THE WAY WE LIKE TO SAY IT WE
HAVE 27 INSTITUTES AND CENTERS
ACROSS NIH.
ALL OF THEM HAVE PROGRAMS THAT
CAN DUCK INTO AND CONTRIBUTE TO
THE WORK THAT'S DONE BY PRIMARY
CARE, BY FOCUS ON PRIMARY CARE
IN CARE FOR HEALTH.
OBVIOUSLY THERE ARE OTHER, YOU
KNOW, SPECIALTY FOCUS AREAS OF
RESEARCH THAT WE WILL CONTINUE
TO DO, YOU KNOW, ONCOLOGY
COMMUNITY IN CANCER TREATMENT,
NOT SOMETHING LIKELY TO BE DONE
IN CARE FOR HEALTH BUT CANCER
SCREENING AND PREVENTION
MODALITIES CERTAINLY WILL.
SO, SEE WHAT I MEAN?
AND CARE FOR HEALTH IS OUR
SIGNATURE ENDURING REALLY
COMPREHENSIVE CROSS-NIH
INITIATIVE TO TO GET RID OF THE
SMALL ONE-OFF OR GIVE PLATFORM
FOR SOME RESEARCHER WITH A
BRILLIANT IDEA FOR ONE TO BE
ABLE TO DOCK INTO AN
INFRASTRUCTURE THAT THEY DON'T
HAVE TO BUILD OFF OF THEIR R01.
SO THAT'S EXACTLY WHY CARE FOR
HEALTH IS CREATED.
WE COULD DO A LOT MORE BUT
THAT'S RIGHT NOW OUR FOCUS FOR
AT LEAST AN EXAMPLE
INFRASTRUCTURE ON HOW TO MAKE
THIS HAPPEN FOR PRIMARY CARE.
>> THANK YOU.
WAFAA?
>> HI.
THANK YOU VERY MUCH.
ACTUALLY FOR THE PRESENTATIONS,
RATHER REMARKABLE, INITIATIVES
ARE AMAZING.
I'M JUST WONDERING I WANTED TO
MENTION -- I SAW ON THE SLIDE
THAT WENT BY QUICKLY ALL THE
COMMUNITY ENGAGEMENT EFFORTS
EMBEDDED IN LARGE PROGRAMS.
I WONDER WHETHER YOU HAD THE
OPPORTUNITY TO CONSIDER THOSE
THAT EXIST WITHIN THE CLINICAL
TRIALS NETWORK, THINKING OF THE
HIV CLINICAL TRIALS NETWORK AND
OTHER CANCER TREATMENT NETWORKS
AND SO ON WHERE NOW LIKE THREE
DECADES OR MORE OF REAL SUCCESS
AND CHALLENGES AND HOW DO YOU
MANAGE THESE KIND OF ENGAGEMENTS
OVER TIME, OVER VERY LONG
PERIODS OF TIME, AND I THINK
ALSO THERE MAY BE SOME IMPORTANT
LESSONS LEARNED THROUGH THESE
LONGSTANDING COMMUNITY
ENGAGEMENT IN THESE NETWORKS AS
WELL AS ALSO DEMONSTRATE SOME
ISSUES RAISED PREVIOUSLY BY I
BELIEVE BRIAN IN TERMS OF
POTENTIAL FOR THINKING OUT OF
THE BOX AND HOW CAN WE USE THOSE
ENTITIES TO SUPPORT OTHER
ENDEAVORS IN THE SAME COMMUNITY
OR WITHIN THE SAME COUNTRY,
SINCE THE NETWORKS ARE OFTEN
U.S. BASED BUT OF COURSE ALSO
INTERNATIONALLY.
JUST A THOUGHT, NOT REALLY A
QUESTION, BUT THERE MAY BE
ADDITIONAL LESSONS LEARNED THAT
COULD BE VALUABLE AS YOU MOVE
FORWARD.
>> IT'S AN EXCELLENT POINT, ONE
OF THE KEYS, AND ALEXA PLEASE
JUMP IN, WHY WE'RE TRYING TO
PAIR THE GROUP GOING INTO
COMMUNITY, WHERE WE MAY NOT HAVE
BEEN BEFORE TO HAVE
CONVERSATIONS TO UNDERSTAND GAPS
AND KNOWLEDGE AND BRIDGE THOSE,
WITH THE INTERNAL GROUP OF NIH
EXPERTS WHO HAVE BEEN DOING
THIS, WORKING IN THESE NETWORKS
AND COMMUNITIES SO WE'RE HAVING
THAT HOLISTIC APPROACH TO WHO
HAS DONE THIS BEFORE, WHO IS
NEW, HOW CAN WE HAVE STRATEGIES
RECOGNIZING VARIOUS
PERSPECTIVES.
>> YEAH, FOCUS GROUPS ARE ALL
OVER THE COUNTRY AND VERY
TARGETED TO MAKE SURE THEY ARE
INCLUSIVE OF REALLY, AGAIN, THE
UNITED STATES IS VERY
HETEROGENEOUS, TO INCLUDE A LOT
OF GROUPS.
I WOULD SAY ONE GROUP THAT MAYBE
WE HADN'T ENGAGED THAT I JUST
BROUGHT INTO THE MIX WAS SOME OF
THE MORE LIKE PROFESSIONAL
SOCIETIES, YOU KNOW, AGAIN,
COORDINATORS ARE GETTING
CERTIFICATES AND CERTIFICATION.
WE NEED TO HEAR FROM THEM, SOME
ARE IN ACADEMIC INSTITUTIONS,
SOME ARE NOT, BUT THERE'S A
GROUP THERE.
THE LISTENING SESSIONS, THEY
HAVE REPORTED BACK, HAVE BEEN
VERY COMPELLING AND I THINK
REALLY CHANGED HOW WE HAVE
PRESENTED SOME OF THE
INFORMATION.
>> TESHIA NEXT PLEASE.
>> I AGREE WITH WAFAA, IT'S BEEN
AN EXCITING DAY BECAUSE YOU'RE
TALKING MY JAM, COMMUNITY
ENGAGEMENT.
I GET EXCITED ABOUT THAT.
I WANT TO COMMEND YOU ALL.
TARA AND LYRIC AND DR. TABAK
HAVE ALL BEEN THE SAME, THEY
HAVE BEEN IN THE SAME ROOM WHEN
THEY HEARD US AT TRIBAL HEALTH
ADVISORY COMMITTEE, TALK ABOUT
WHAT WE NEED.
WHAT I'VE HEARD TODAY OVER AND
OVER IS YOU'VE LISTENED TO WHAT
WE'VE SAID AND IT'S BEING
APPLIED.
WE'VE ASKED YOU TO REACH TO
COMMUNITY.
WE'VE ASKED YOU ABOUT, YOU KNOW,
DATA SOVEREIGNTY.
WE'VE ASKED FOR ALL THESE THINGS
AND I'M HEARING IT COME TO
FRUITION.
I THANK YOU FOR LISTENING AND
ASKING.
I THINK THAT WAS SOMETHING THAT
LYRIC SAID.
FEEDBACK TO ACTION.
SO APPRECIATE THAT GREATLY.
I ALSO -- I'M SO EXCITED ABOUT
WHAT YOU'RE DOING IN TERMS OF
COMMUNITY ENGAGEMENT.
WORKING WITH THE "ALL OF US"
PROGRAM WE UNDERSTAND HOW
INCREDIBLY IMPORTANT IT IS TO BE
SUCCESSFUL, PARTICULARLY IN BIG
SCALE PROJECTS, TO HAVE THAT
COMMUNITY PIECE BE THERE AND
HAVE IT BE MEANINGFUL.
I'D LIKE TO ASK YOU BE CLEAR IN
WAYS TO MEASURE THAT SUCCESS
ACROSS THE LINEAR PARADIGM FROM
WHERE YOU'RE STARTING, IF IT'S
THE BENCH SIDE AND YOU'RE
PUTTING IT OUT THERE, HOW ARE WE
GETTING TO MOVE THAT, HOW ARE WE
AFFECTING HEALTH EQUITY, HOW ARE
WE AFFECTING DISEASE, AFFECTING
INCLUSION IN RESEARCH, ALL OF
IT, MEASURE AND SHOW TRAJECTORY
AND PARTICIPATE IN THIS WAY,
ENGAGING COMMUNITY IS HAVING
EFFECT.
THE MORE WE DO THAT, THE MORE
THAT WE'RE GOING TO HAVE
RESPONSIVENESS FROM THE
COMMUNITY MEMBERS BUT ALSO FROM
OUR OVERSEER FOR OVERSIGHT,
WHOEVER THAT MIGHT BE.
WHATEVER YOU'VE GOTTEN, LET'S BE
SURE TO DO THAT AND COMMUNICATE
IT BACK OUT.
>> THANK YOU, SO IMPORTANT.
LYRIC SAID IT.
I WROTE IT DOWN.
BECAUSE I WANTED TO REPEAT IT.
THESE FRAMEWORKS, ROAD MAPS,
EVERY SINGLE ONE OF THEM THAT
YOU'VE HEARD PRESENTED TODAY IS
BUILT TO DELIVER NEEDED OUTCOMES
AND ALSO BUILT INTO THE ROAD
MAPS ARE TRACKING.
TWO THINGS.
BUT TRACKING OF THOSE OUTCOMES,
BUT ALSO FLEXIBILITY TO RESPOND
TO EVOLVING CONDITIONS.
SO, THOSE TWO THINGS ARE
ESSENTIAL TO THESE ROAD MAPS.
>> ANY ADDITIONAL COMMENTS?
>> AND NOW SOMETHING COMPLETELY
DIFFERENT.
WHY DON'T WE TAKE A 10-MINUTE
BREAK.
AND WE'LL RECONVENE AT 4:30 WHEN
YOU'RE CONSTRUCTING SCHEDULESES
YOU PUT THE BOSS AT THE
BEGINNING AND YOURSELF LAST.
THAT'S HOW WE'RE HERE IN THE
LAST TALK.
WE'LL SEE YOU BACK IN TEN QUICK
MINUTES. THANKS.
>> OKAY, THANKS.
WE'RE GOING TO SWITCH GEARS
AND TALK ABOUT THE RESTART OF
THE SCIENTIFIC MANAGEMENT AND
REVIEW BOARD.
SO IF WE COULD HAVE THE NEXT
SLIDE PLEASE.
JUST BY WAY OF BACKGROUND,
AUTHORIZED BY NIH FOR 2006, NOT
DISSIMILAR TO THIS ACD
COMMITTEE, EQUIVALENT IN THE WAY
THEY OPERATE IN MANY WAYS BUT
THERE'S SOME DIFFERENCES WHICH
I'LL POINT OUT IN A BIT.
THE PURPOSE OF THESE SCIENTIFIC
MANAGEMENT REVIEW BOARD IS TO
ADVISE NIH AND DEPARTMENT OF
HEALTH AND HUMAN SERVICES
OFFICIALS ON USE OF THE AGENCY
ORGANIZATIONAL AUTHORITIES TO
ESTABLISH OR ABOLISH INSTITUS
AND CENTERS.
NEXT PLEASE.
THE HISTORY IS SUMMARIZED IN THE
NEXT SLIDE.
THE SCIENTIFIC MANAGEMENT REVIEW
BOARD INITIALLY IS PART OF ITS
FIRST BOARD DEVELOPED A
FRAMEWORK FOR THE CONSIDERATION
OF ORGANIZATIONAL CHANGE.
AMONG NOTABLE RECOMMENDATIONS
WAS PROPOSED MERGE EVER OF THE
NATIONAL INSTITUTE ON DRUG ABUSE
AND NATIONAL INSTITUTES ON
ALCOHOL ABUSE AND ALCOHOLISM AND
CREATION OF NATIONAL CENTER FOR
ADVANCING TRANSLATIONAL
SCIENCES.
SO THEY RECOMMENDED CREATION OF
A NEW INSTITUTE AND RECOMMENDED
MERGER OF TWO INSTITUTES INTO
ONE.
THE COMMITTEE AS PREVIOUSLY
CONSTITUTED LAST MET IN 2015.
THE PREVIOUS ADMINISTRATION, THE
FIRST TRUMP ADMINISTRATION, HAD
WANTED TO REDUCE NUMBER OF FACA
COMMITTEES.
WE PROPOSED THE SCIENTIFIC
MANAGEMENT REVIEW BOARD BE ONE
OF THOSE THAT WOULD BE
ELIMINATED BECAUSE OVER TIME DR.
COLLINS WAS USING THE ADVISORY
COMMITTEE TO THE DIRECTOR MORE
AND MORE FOR BROADER RANGE OF
ACTIVITIES BUT THAT REQUEST,
THAT PROPOSAL WAS NEVER ACTED
UPON BY THE CONGRESS AND SO THE
SCIENTIFIC MANAGEMENT REVIEW
BOARD LAY DORMANT FROM 2015 ON.
NEXT PLEASE.
SO, IN ADDITION TO THE CHANGE
AND EFFECTIVENESS REPORT ISSUED
IN 2010 THERE WERE ALSO REPORTS
ON SUBSTANCE USE ABUSE AND
ADDICTION, THAT REFERS TO THE
RECOMMENDATION THAT NIDA AND
NIAAA BE MERGED, THERE WAS ALSO
A REPORT ON THE INTRAMURAL
PROGRAM, CLINICAL CENTER, AND
ADDITIONAL REPORT ON TRANSLATION
MEDICINE AND THERAPEUTICS, ALL
OF THIS WORK DONE IN 2010.
SO A QUICK START.
NEXT PLEASE.
CONTINUING WITH THOSE HIGHLIGHTS
IN 2013 A REPORT ON THE
SO-CALLED SBIR PROGRAM, OUR
CONGRESSIONALLY MANDATED SMALL
BUSINESS INNOVATION RESEARCH AND
SMALL BUSINESS TECH TRANSFER
PROGRAM.
IN 2014 APPROACHES TO ASSESSING
THE VALUE OF BIOMEDICAL
RESEARCH.
IN 2015 IN JANUARY A REPORT ON
PRE-COLLEGE ENGAGEMENT IN
BIOMEDICAL SCIENCE, HISTORICALLY
NIH HAS NOT SPENT A LOT OF TIME
IN THE PRE-COLLEGE SPACE, THREE
PROGRAMS MODEST IN SIZE.
FINALLY, THIS REPORT ON GRANT
REVIEW, AWARD, AND MANAGEMENT
PROCESSES DOESN'T READ GRUMP,
IT'S GRAMP.
[LAUGHTER]
AND THAT WAS THE FINAL REPORT
BEFORE THE COMMITTEE SUNSET.
NEXT PLEASE.
SO, AS TO WHY WE HAVE RESTARTED
THE SCIENTIFIC MANAGEMENT AND
REVIEW BOARD, TWO REASONS.
THE FIRST IN OUR 2024
APPROPRIATIONS LANGUAGE IT WAS
WRITTEN THAT THE COMMITTEE
DIRECTS NIH TO RECONVENE SMRB
WITHIN ONE YEAR OF ENACTMENT IN
ORDER TO FULFILL STATUTORY DUTY
TO ADVISE CONGRESS, SECRETARY,
NIH DIRECTOR HOW BEST TO
ORGANIZE BIOMEDICAL RESEARCH
FUNDING AND THIS WAS A COMMITTEE
THAT NEWLY APPOINTED NIH
DIRECTOR AT THE TIME DR.
BERTAGNOLLI THOUGHT WOULD BE
VALUABLE SO THE TWO COALESCED,
SYNERGIZED, AND WE BEGAN TO
STAND THIS COMMITTEE BACK UP
AGAIN.
NEXT PLEASE.
THERE ARE A NUMBER OF
INTERESTING STATUTORY RULES AND
REQUIREMENTS REGARDING THE SMRB
WHICH DIFFER FROM THE APPROACH
THAT WE USE IN THE ADVISORY
COMMITTEE TO THE DIRECTOR.
BOTH ARE FACA COMMITTEES, AND
THEREFORE SIMILAR, THEY ARE
DISSIMILAR IN SOME SPECIFIC
RULES AND REQUIREMENTS ON HOW
THINGS WORK.
SO, IT IS REQUIRED NOT LESS THAN
ONCE EACH SEVEN YEARS THE BOARD
WILL ISSUE A REPORT TO THE NIH
DIRECTOR AND OTHER APPROPRIATE
AGENCY OFFICIALS.
AND SO THAT SEVEN-YEAR
REQUIREMENT WAS TRIGGERED AND IN
THE VIEW OF CONGRESS WAS NOT MET
BECAUSE WE LAST MET IN 2015 WHEN
REPORTS WERE ISSUED, AND THERE
WE ARE IN 2024 AND HADN'T ISSUED
A REPORT, EFFECTIVELY EIGHT TO
NINE YEARS.
THE BOARD WILL DETERMINE WHETHER
AND TO WHAT EXTENT THE NIH
ORGANIZATIONAL AUTHORITIES
SHOULD BE USED, SO ONE IS NOT
OBLIGATED TO USE THOSE BUT
RATHER THE BOARD IS SUPPOSED TO
RECOMMEND WHETHER THEY SHOULD
AND TO WHAT EXTENT THEY SHOULD
BE USED.
AND THE REPORT WILL PROVIDE
RECOMMENDATIONS REGARDING THE
USE OF ORGANIZATIONAL
AUTHORITIES AND THE REASONS
BEHIND THOSE UNDERLYING
RECOMMENDATIONS.
BEFORE THIS BOARD CAN ISSUE A
REPORT, IT NEEDS TO CONSULT WITH
A VERY BROAD RANGE OF
STAKEHOLDERS.
IT HAS TO CONSULT WITH
NON-MEMBER INSTITUTE AND CENTER
DIRECTORS BECAUSE YOU'LL SEE IN
A MOMENT THAT ANOTHER UNUSUAL
FEATURE OF THE SMRB IS IN
ADDITION TO OUTSIDE MEMBERS, IT
ALSO HAS STANDING INSTITUTE AND
CENTER DIRECTORS AS PART OF THE
MEMBERS.
SO, BEFORE ISSUING A REPORT, THE
BOARD HAS TO CONSULT WITH I.C.
DIRECTORS NOT ON THE SMRB.
IT ALSO HAS TO CONSULT WITH
OTHER NON-MEMBER AGENCY
SCIENTIFIC LEADERS.
IT HAS TO CONSULT WITH RELEVANT
I.C. ADVISORY COUNCILS, SO THAT
WOULD INCLUDE THINGS LIKE THE
ACD, COUNCIL OF COUNCILS, AND IF
INTERPRETED STRICTLY, ALL THE
COUNCILS OF THE DIFFERENT
INSTITUTES AND CENTERS.
FURTHER, IT WOULD REQUIRE
CONSULTATION WITH ORGANIZATIONS
BROADLY REPRESENTING THE
SCIENTIFIC COMMUNITY AND
ORGANIZATIONS REPRESENTING
PATIENTS.
AND SO AGAIN BEFORE ISSUING A
REPORT THERE'S AN OBLIGATION TO
DO THIS VERY EXTENSIVE OUTREACH.
NEXT PLEASE.
AND OF THE MEETINGS HELD WITH
RESPECT TO ISSUING A REPORT, ONE
OR MORE MUST BE DIRECTED TO THE
SCIENTIFIC COMMUNITY AND ONE OR
MORE MUST BE DIRECTED TOWARDS
CONSUMER ORGANIZATIONS.
SO THERE'S A LOT OF
SPECIFICATION AS PECIFICATION AE
SUPPOSED TO WORK TOWARD ISSUING
A REPORT.
AND FINALLY THE BOARD MUST MEET
AT LEAST FIVE TIMES BEFORE IT
ISSUES A REPORT.
SO, IT IS BOTH AN APPROACH THAT
ENSURES EXHAUSTIVE INPUT BUT IT
IS ALSO AN APPROACH THAT IS NOT
PARTICULARLY RAPID.
AND SO WE HAVE THIS SORT OF, YOU
KNOW, ISSUES THAT WE HAVE TO
DEAL WITH BUT IT DOES ENSURE
THAT YOU GET VERY, VERY BROAD
INPUT.
NEXT PLEASE.
SO, IN TERMS OF THE MEMBERSHIP,
IT'S COMPOSED OF AN ODD NUMBER
OF MEMBERS, AS I ALLUDED TO
EARLIER, CONSISTING OF THE
DIRECTORS, STANDING DIRECTOR OF
NIH INSTITUTES AND CENTERS, AND
ALSO CONSISTS OF INDIVIDUALS
FROM NIH-FUNDED INSTITUTIONS AND
ALSO A BROAD RANGE OF EXPERTISE
ON HOW, YOU KNOW, NIH WORKS.
OUR CURRENT SHARE CHAIR IS DR.
ANDREA HAYES DIXON, DEAN OF THE
COLLEGE OF MEDICINE OF HOWARD
UNIVERSITY.
THE FULL CURRENT MEMBERSHIP CAN
BE FOUND AT THAT WEBSITE AND YOU
CAN CLICK ON THAT AND YOU CAN
SEE WHO IS ON THE BOARD.
NEXT PLEASE.
SO, THE NIH DIRECTOR IN NOVEMBER
PROVIDED THE FIRST INITIAL
CHARGE TO THE RESTARTED SMRB
BOARD.
SHE REQUESTED THAT THE SMRB
EVALUATE THE CURRENT STRUCTURE
OF NIH AND PROPOSE CHANGES TO
ENHANCE THE ABILITY OF THE
AGENCY TO FULFILL ITS MISSION
AND TO ADDRESS THAT CHARGE
INDICATED THE SMRB SHOULD FIRST
REEXAMINE THE 2010 SMRB REPORT,
DELIBERATING ORGANIZATIONAL
CHANGE AND EFFECTIVENESS, TO
DECIDE WHETHER OR NOT THE
CURRENT CRITERIA SHOULD BE
UPDATED THAT ARE IN THAT REPORT,
TO DETERMINING WHEN
ORGANIZATIONAL CHANGE SHOULD BE
CONTEMPLATED AND SECONDLY SHE
INDICATED THAT THE SMRB SHOULD
CONSIDER RECENT PROPOSALS IN THE
HOUSE ENERGY AND COMMERCE
COMMITTEE AND SENATE HELP
COMMITTEE.
NEXT SLIDE PLEASE.
THE NIH ALSO REQUESTS THAT THE
SMRB EVALUATE THE CURRENT
STRUCTURE WITH REGARD TO
EVALUATING EXISTING GUIDING
PRINCIPLES IN THE PROCESS OF
DELIBERATING PROPOSED
ORGANIZATIONAL CHANGES AND
REFINE RECOMMENDATIONS OF ANY
ORGANIZATIONAL CHANGE THAT THEY
FEEL WOULD ENHANCE THE ABILITY
OF THE AGENCY TO FULFILL ITS
MISSION.
NEXT PLEASE.
SO, I'VE MENTIONED THIS REPORT,
DELIBERATING ORGANIZATIONAL
CHANGE AND EFFECTIVENESS, THE
LINK TO THE PDF IS ON THIS SLIDE
ON THE LEFT.
AND I MUST SAY IT IS A VERY
VALUABLE DOCUMENT.
IT ENUMERATES A SERIES OF
GUIDING PRINCIPLES AS TO WHY ONE
WOULD DO THIS.
FIRST AND FOREMOST TO STRENGTHEN
THE ABILITY OF NIH TO CARRY OUT
ITS MISSION.
TO SECONDLY PROVIDE THE
ENVIRONMENT FOR COLLABORATION,
COORDINATION, INTERACTION.
NOT SURPRISINGLY THE HOPE BEING
TO BRING TOGETHER SYNERGIES.
TODAY WE SPENT A LOT OF TIME ON
PUBLIC OUTREACH.
THAT'S ONE OF THE GUIDING
PRINCIPLES.
WHAT WE DO SHOULD ENHANCE PUBLIC
UNDERSTANDING, CONFIDENCE, AND
SUPPORT.
FINALLY SHOULD INCREASE
OPERATIONAL EFFICIENCY, IN TERMS
OF STEPS AS YOU NO DOUBT PREDICT
FIRST ASSESS NEED FOR CHANGE,
SECOND EVALUATE OPTIONS FOR SUCH
CHANGE AND THIRD EVALUATE AND
IMPLEMENT SUCH CHANGE.
THROUGHOUT ALL THE ACTIVITIES
THERE ARE THINGS THAT UNDERGIRD
EVERYTHING NAMELY TRANSPARENCY,
COMMUNICATION, ACCOUNTABILITY.
SO EVEN BACK IN 2010 WE WERE
TALKING ABOUT THESE VERY
PRINCIPLES.
AS YOU CAN SEE THESE HAVE BEEN
DEVELOPED FURTHER OVER TIME
WHERE WE NOW HAVE VERY ROBUST
APPROACHES.
NEXT SLIDE PLEASE.
NOW, THERE ARE A SPECTRUM OF
OPTIONS FOR ORGANIZATIONAL
CHANGE AND THEY RANGE FROM DOING
NOTHING TO DOING FUNCTIONAL
CHANGES SO YOU CAN ACHIEVE THE
VALUE AND BENEFITS THAT YOU HOPE
TO WITHOUT GOING THROUGH THE
SOMETIMES CUMBERSOME REQUIREMENT
OF EFFECTING A CHANGE IN A
FEDERAL ENVIRONMENT.
THE PICTOGRAM HERE TRIES TO
SUMMARIZE THE VARIOUS
APPROACHES.
I WILL TELL YOU THAT WE HAVE
USED EVERY SINGLE ONE SAVE FOR
ONE, THE PENULTIMATE READING
LEFT TO RIGHT, WE CAN GIVE YOU
EXAMPLES OF EVERY SINGLE ONE.
NOW, WE MAY HAVE A SITUATION
WHERE YOU DECIDE NOT TO DO A
CHANGE.
THAT'S WHERE USUALLY WHEN PEOPLE
CLAMOR FOR CHANGE WE SELECT ONE
OF THE REMAINING OPTIONS.
OFTEN IT IS A MERGER OF SELECT
INITIATIVES FROM TWO INSTITUTES
OTHER CENTERS.
VERY OFTEN TWO INSTITUTES AND
CENTERS COME TOGETHER TO CREATE
A NEW INITIATIVE, NOT ONE THAT'S
EXISTING.
INCREASINGLY AND PARTICULARLY
UNDER MARTHA'S WATCH NEW
INITIATIVES HAVE BUBBLED UP, OF
COURSE MULTIPLE INSTITUTES AND
CENTERS, CLUSTERED FUNCTIONS,
BUILDING ON STRENGTHS OF TWO OR
MORE ENTITIES, TO ENSURE THE
BEST OF CLASS OR ONE INSTITUTES
MAY DO ONE THING REALLY WELL,
ANOTHER MAY DO ANOTHER THING
REALLY WELL.
AND I THINK THAT WE HAVE HAD
EXAMPLES OF THAT, IN PARTICULAR
NIDA AND NIAAA CLUSTERED THEIR
FUNCTIONS, I THINK THEY HAVE
EQUAL STRENGTHS IN MANY DOMAINS
BUT THEY ARE LOOKING AT SIMILAR
SCIENCE FROM SLIGHTLY DIFFERENT
PERSPECTIVES.
AND SO WE HAVE CLUSTERED THEIR
APPROACH AND EFFORTS IN A VERY
SERIOUS WAY INCLUDING ONE JOINT
COUNCIL MEETING A YEAR.
WE HAVE NEVER MERGED INSTITUTES
AS A RESULT OF THE SMRB PROCESS.
ONE WAS PROPOSED, NIDA AND NIAA.
THAT DID NOT OCCUR.
BUT THIS CLUSTERED APPROACH DID
IN FACT OCCUR.
WE HAVE THE COME-ON LINE WITH A
NEW INSTITUTE SINCE SMRB, THAT
OF COURSE IS NCATS.
SOME OF US HAVE BEEN HERE LONG
ENOUGH TO REMEMBER OTHER NEW
INSTITUTES THAT CAME ALONG.
MOST RECENT BEFORE NCATS WAS
NIBIB.
SO WE HAVE IN FACT HAD NEW
INSTITUTES CREATED.
NEXT SLIDE PLEASE.
SO AS PART OF THE CHANGE JUST TO
REITERATE AND EMPHASIZE,
REEVALUATE, EXISTING GUIDELINES
FOR PROCESS OF DELIBERATING
PROPOSED ORGANIZATIONAL CHANGES
BE ON THE NEXT SLIDE, AND ALSO
TO CONSIDER THE CONGRESSIONAL
INTEREST AT NIH ORGANIZATION
STRUCTURE, ON THE LEFT IS A
REPORT FROM THE SENATE, 2024 NIH
AND 21ST CENTURY REPORT ENSURING
TRANSPARENCY IN AMERICAN
BIOMEDICAL LEADERSHIP, RANKING
MEMBER CASSIDY WAS THE
COMMUNICATOR OF THAT REPORT.
AND THEN ON THE RIGHT THE 2024
REPORT FROM THE HOUSE ENERGY AND
COMMERCE COMMITTEE, CHAIRMAN
MCMORRIS RODGERS WAS
COMMUNICATOR OF THAT REPORT.
THE FRAMEWORK, THE DISCUSSION,
2024 REFORMING THE NIH, AND BOTH
CONTAIN SOME VERY VALUABLE
RECOMMENDATIONS AND SUGGESTIONS,
AND THESE TOO SHOULD BE AND WILL
BE CONSIDERED BY SMRB.
IF I CAN HAVE THE NEXT SLIDE
PLEASE.
SO, WE DID MEET, AS DR.
BERTAGNOLLI MENTIONED EARLIER
TODAY.
ON NOVEMBER 12.
AND THERE WERE A NUMBER OF
THEMES THAT EMERGED FROM THAT
FIRST MEETING.
I'M SUMMARIZING AN ALL-DAY
MEETING SO FORGIVE THE BREVITY.
BUT IN GENERAL HOW DO WE
REESTABLISH TRUST AND BETTER
COMMUNICATE THE IMPACT OF NIH
INVESTMENTS.
I THINK YOU HEARD MANY IMPORTANT
IDEAS HERE TODAY WHERE THROUGH
IMPLEMENTATION AND EXECUTION AND
BROADENING OUT WE CAN EFFECT
THAT FOR CERTAIN, ENGAGING
COMMUNITIES AROUND THE NATION.
HOW ARE WE INCREASING THE IMPACT
OF OUR WORK?
WE'RE ALWAYS LOOKING FOR WAYS TO
INCREASE AND ENHANCE THE IMPACT
OF OUR WORK.
PRIORITIZING COMMUNITY
PARTNERSHIP.
AND SO MUCH OF TODAY'S MEETING
WAS INVOLVED WITH THAT.
AND OF COURSE PRIORITIZING
HEALTH DISPARITIES ACTIVITIES
AND RESEARCH.
AGAIN, THAT WAS CERTAINLY
ALLUDED TO THROUGHOUT TODAY'S
ACTIVITIES AS WELL.
NEXT PLEASE.
SO WHAT ARE THE NEXT STEPS FOR
THE SCIENTIFIC MANAGEMENT REVIEW
BOARD?
WE WILL BE MEETING SOMETIME IN
JANUARY VIRTUALLY.
WE HAVE DECIDED ON A CADENCE TO
TRY AND DO A MINIMUM OF FIVE
MEETINGS IN THE YEAR.
ALTERNATING BETWEEN IN-PERSON
MEETINGS WHICH OCCURRED FOR THE
FIRST MEETING WITH VIRTUAL
MEETINGS WHICH WILL OCCUR FOR
THE NEXT MEETING AND SO FORTH.
WE WANT TO DISCUSS THE GROUP'S
OVERALL STRATEGY TO COALESCE ON
THINGS THAT WORKED AND NOT
WORKED PERHAPS IN THE
INTERVENING YEAR SINCE THE
SUNSET, YOU KNOW, STASIS OF THE
COMMITTEE.
WE WANT TO BEGIN TO ARTICULATE
AND IDENTIFY WHAT TYPE OF DATA
WE NEED OVER TIME TO HELP INFORM
COMMITTEE'S DELIBERATION.
WANT TO OUTLINE SOME KEY
QUESTIONS AND SET PRIORITIES, IN
SO DOING THE GROUP CAME TO
CONSENSUS WE REALLY NEED
TANGIBLE METRICS TO MAKE SURE
THAT WE'RE DELIVERING WHAT WE
ARE GOING TO BE DELIVERING.
BLUE SKY-ING IS FUN BUT I THINK
WE'RE GOING TO FOCUS ON TACTICAL
RATHER THAN THE LATTER.
THERE ARE SOME QUESTIONS AND
PRIORITIES VIS-A-VIS FISCAL
STABILITY, AND NO DOUBT THAT
CONVERSATION COULD INFORM A
NUMBER OF THINGS.
THERE WAS SOME QUESTION ABOUT
IMPLEMENTATION SCIENCE,
SOMETHING THAT WAS OF COURSE
BROUGHT UP HERE TODAY.
AND HAS BEEN IN MANY ACD
MEETINGS.
AND THEN FINALLY THE NEED TO
CONTINUE TO USE THE NIH
PARTICULARLY THE INTRAMURAL
RESEARCH PROGRAM AS INCUBATOR
SPACE.
YOU HEARD ABOUT SOME PILOT
PROGRAMS, ALSO WE DO THESE
THINGS IN THE INTRAMURAL SPACE.
IN TERMS OF MEETING CADENCE
WE'RE GOING TO HAVE A SHORTER
VIRTUAL MEETING, HAVEN'T QUITE
GOTTEN THE DATE YET BUT WE'LL
HAVE IT VERY SHORTLY.
AND IN ORDER TO AMPLIFY WHAT THE
COMMITTEE IS ABLE TO DO, THE
CHAIR WILL ESTABLISH A SERIES OF
WORKING GROUPS SO THAT WE CAN
DIVIDE AND CONQUER, WORKING IN
PARALLEL RATHER THAN WORKING CON
CONSECUTIVELY LEST WE FALL PREY
TO THE FIVE-MEETING RULE BEFORE
ISSUING A REPORT.
IF THERE'S HOPE OF ISSUING MORE
THAN ONE REPORT, IN THIS YEAR'S
PERIOD, WE WILL HAVE TO, YOU
KNOW, DO SOME, YOU KNOW,
PARALLEL PROCESSING RATHER THAN
CONSECUTIVE EFFORT.
NEXT PLEASE.
SO, WITH THAT QUICK RUN-THROUGH,
I HOPE I'VE ANSWERED AT LEAST
SOME QUESTIONS THE ACD MAY HAVE
ABOUT THIS NEWLY FORMED OR
REBORN, IF YOU WILL, BOARD.
WE WILL AS APPROPRIATE BRING
BACK THE DELIBERATIONS OF THE
SMRB TO THE ACD AND ULTIMATELY
TO THE OTHER COMMITTEES AROUND
THE AGENCY, COUNCIL OF COUNCILS,
AND THE VARIOUS I.C. BOARDS.
BUT WE WANTED TO START WITH THE
ACD AT THIS MOST NASCENT MOMENT
TO GET SOME FEEDBACK YOU MAY
HAVE.
I'LL TURN IT TO MONICA TO
COMMENT AND WE CAN GET QUESTIONS
AND COMMENTS FROM EVERYBODY
ELSE.
>> A FEW QUICK COMMENTS.
THANK YOU, LARRY, FOR SETTING IT
UP, EXACTLY THE HISTORY AND WHY
THIS NEW BOARD IS NOW
RECONVENED.
YOU KNOW, THE SMRB IS A
CONGRESSIONALLY MANDATED FACA
COMMITTEE THAT HAS BEEN DORMANT
FOR EIGHT YEARS BUT IT REMAINS
CONGRESSIONALLY MANDATED FACA
COMMITTEE.
THE REASON I CALLED FOR ITS
RECONVENING SHORTLY AFTER MY
ARRIVAL AS DIRECTOR IS THAT IT
IS THE RESPONSIBILITY OF THE NIH
DIRECTOR I BELIEVE TO CERTAINLY
TO BE RESPONSIVE TO REQUIREMENTS
THAT CONGRESS PUTS FORWARD IN
LEGISLATION.
SO, THAT IS WHAT WE ARE DOING
HERE AND VERY CLEARLY AS LARRY
OUTLINED ABIDING BY THE
REQUIREMENTS THAT CONGRESS HAS
PLACED IN LEGISLATION TOWARDS
WHAT THIS -- HOW THIS BOARD IS
CON FIGURED AND WHAT IT IS
CONVENED TO DO.
TWO CHARGES RIGHT NOW, TO HELP
TO REVIEW THE PAST
RECOMMENDATIONS, THE LAST REPORT
THAT WAS PROVIDED BY THE GROUP
WHICH I THINK IF YOU ALL HAVE A
CHANCE TO LOOK AT IT IS REALLY
AN OUTSTANDING REVIEW AND SET OF
RECOMMENDATIONS.
AND THEN SECOND, WHICH AROSE
LATER, WAS TO BE ABLE TO RESPOND
NOW TO CURRENT CONGRESSIONAL
RECOMMENDATIONS, ONE FROM THE
HOUSE, ONE FROM THE SENATE.
FINALLY, I JUST WANT TO
EMPHASIZE THE CHARGE AND
EFFECTIVENESS AND VALUE OF THE
ACD DOESN'T CHANGE A SINGLE BIT
BY THE REESTABLISHMENT OF THIS
NEW COMMITTEE.
THE PARTICULAR FOCUS OF THE ACD
AT LEAST AS FAR AS WE HAVE
WORKED TOGETHER HAS BEEN
SCIENTIFIC INITIATIVES, POLICY
DEVELOPMENT, AND STRATEGIES FOR
HOW WE CAN BETTER EXECUTE,
PRIORITIES FOR OVERALL RESEARCH
AND EXECUTE ON THOSE PRIORITIES.
I THINK THE SMRB, IF YOU LOOK AT
WHAT IT'S CHARGE IS, IT'S MORE
ABOUT INFRASTRUCTURE,
ADMINISTRATION, TO DELIVER
BETTER RESULTS BUT HAS LARRY
DESCRIBED IN THE REQUIREMENTS IT
IS ALSO -- THESE CAN'T BE
SILOED, THE TWO COMMITTEES, AND
THERE ARE BUILD INTO
REQUIREMENTS TO INTERACT WITH
THE ACD BEFORE RECOMMENDATIONS
OR ACTIONS ARE TAKEN.
SO I REALLY DON'T -- I THINK
THIS IS AN ADDITIVE, NOT A
SUBTRACTION IN ANY WAY FROM THE
WORK THAT YOU ARE ALL DOING AND
I REALLY -- I THINK THE PEOPLE
WHO AGREED TO SERVE ON THIS NEW
COMMITTEE AND LOOK FORWARD TO
SEEING WHAT ARISES FROM IT.
SO THANK YOU.
>> THANK YOU.
WHILE WE'RE WAITING FOR PEOPLE
TO QUEUE UP COMMENTS OR
QUESTIONS I WANT TO ADD PUTTING
TOGETHER A FACA COMMITTEE IN A
VERY, VERY RAPID TIME IT TAKES A
TEAM EFFORT.
OKAY?
SO I WANT TO THANK TYRA, SARAH,
REBECCA, STEPHANIE, DANA,
CLAIRE, AND MANY OTHER PEOPLE
WHO HELPED.
I KNOW THAT PEOPLE WERE CRITICAL
WHY DID IT TAKE US SO LONG.
THIS IS THE FASTEST WE'VE EVER
PUT TOGETHER A FACA COMMITTEE IN
THE 25 YEARS I'VE BEEN AT NIH.
SO I WANT TO THANK THE TEAM FOR
REALLY MAKING THIS HAPPEN.
WHO WOULD LIKE TO POSE A
QUESTION OR MAKE A COMMENT?
OKAY.
BRIAN, YOU'RE UP.
>> YEAH, SO YOU MENTIONED
IMPLEMENTATION SCIENCE AS ONE OF
THE TOPICS WHICH AS YOU
REFLECTED HAS COME UP A LOT IN
THE ACD MEETING.
I'M WONDERING ABOUT TAKE THAT
EXAMPLE, HEARING HOW THIS
COMMITTEE WOULD APPROACH IT
VERSUS WHAT ACD'S ROLE WOULD BE
IN A SCIENTIFIC INITIATIVE LIKE
THAT, IT MIGHT HELP US
UNDERSTAND DIFFERENCES BETWEEN
THE COMMITTEES.
>> THANKS, BRIAN.
THAT'S A VERY GOOD WAY OF
FRAMING IT.
I THINK FROM THE PERSPECTIVE OF
THE SMRB, THEY WONDER IF THERE
ARE STRUCTURAL BARRIERS THAT
PREVENT OR MAKE MORE DIFFICULT
THE ABILITY OF NIH TO IMPLEMENT
THIS TYPE OF SCIENCE,
IMPLEMENTATION SCIENCE, RIGHT?
AND IF THERE ARE STRUCTURAL
BARRIERS, THAT IT WOULD BE THEIR
JOB TO RECOMMEND APPROACHES TO
DISSOLVE THOSE BARRIERS.
IN CONTRAST I THINK THE ACD
WHICH YOU'VE ALREADY BEEN
INVOLVED WITH, YOU KNOW, ARE
GOING TO TALK MORE ABOUT THE
VARIOUS SCIENTIFIC QUESTIONS
THAT MIGHT BE BEST ADDRESSED BY
IMPLEMENTATION SCIENCE.
SO I THINK THAT'S THE
DEMARCATION.
AND OBVIOUSLY THE TWO HAVE BEEN
SYNERGIZED VERY WELL.
>> ALSO I'LL ADD THE ACD, YOU
KNOW, WHAT KIND OF PRIORITY DOES
IMPLEMENTATION SCIENCE SIT WITH
REGARD TO ALL OF THE OTHER
DISCIPLINES THAT NIH NEEDS TO
ENCOMPASS THAT MORE OF AN ACD
ISSUE.
>> CORRECT.
OTHER COMMENTS OR QUESTIONS?
I HAVE ANESTHETIZED EVERYBODY.
MY GOODNESS.
>> NO, YOU MADE IT TOTALLY
CLEAR.
>> OKAY.
ONE MORE CHANCE AND I'M GOING TO
TURN IT OVER TO MONICA.
I CAN SEE THE BUBBLES OVER
EVERYBODY'S HEAD, WE'RE ALMOST
DONE, WE'RE ALMOST DONE!
OKAY.
THAT'S IT.
MONICA, I'M TURNING IT TO YOU.
>> I'M GOING TO WRAP US UP
QUICKLY.
QUICK RECAP, DAY 1, NEXT SLIDE.
WE'VE HAD PRESENTATIONS TODAY ON
LATEST EFFORTS OF NIH INCLUDING
LEEREDSHIP CHANGES, AWARDS,
EVENTS.
THE BUDGET, WHAT'S GOING ON IN
CONGRESS.
THE SMRB.
POLICY UPDATES, MISSION
STATEMENTS, AND SO OUR
DEDICATION TO CONTINUING TO
SERVE AND MAKE EFFECTIVE
TRANSITION TO INCOMING
ADMINISTRATION AND CONGRESS.
WE'VE ALSO GIVEN YOU DETAILED
FOLLOW-UP TO OUR ACD WORKING
GROUPS AND PROGRAMS AND
INITIATIVES.
I REALLY HOPE WE HAVE
DEMONSTRATED WHAT I REALLY FIND
TO BE THE CASE THAT WE HAVE BEEN
RESPONSIVE TO YOUR
RECOMMENDATIONS, YOUR INPUT INTO
WHAT WE'RE DOING AND THAT WE
HAVE -- WE'RE REALLY DELIVERING
RESULTS.
WE'VE GOT SOLID PROGRESS TO SHOW
ON SOME REALLY IMPORTANT
RECOMMENDATIONS FROM THE ACD
WORKING GROUP.
AND FROM NEW PROGRAMS AND
INITIATIVES THAT ARE RESPONSIVE
TO YOUR RECOMMENDATIONS.
FINALLY WE'VE HAD TIME FOR
SCIENCE HIGHLIGHTS WHICH TO ME
ARE ALWAYS THE BEST PART OF THE
WHOLE MEETING.
THESE ARE PARTICULARLY
HIGHLIGHTING YOUNGER
INVESTIGATORS HERE IN THE
INTRAMURAL PROGRAM.
NEXT SLIDE.
SO, I REALLY APPRECIATE YOUR
THOUGHTS ON THE WORK WE DO AND
NEXT STEPS.
TOPICS DISCUSSED TODAY THAT, YOU
KNOW, I WOULD APPRECIATE YOUR
THOUGHTS.
GIVE US SOME FEEDBACK, THINK
ABOUT THIS.
THE SMRB, AND ITS FORTHCOMING
RECOMMENDATIONS TO GUIDE THE
FUTURE OF NIH.
BROAD OWNERSHIP AND BROAD
APPLICABILITY OF OUR EFFORTS TO
DIVERSIFY SCIENTIFIC
PERSPECTIVE, ENGAGEMENT WITH
DISABILITY COMMUNITY, LONG COVID
AND RECOVER AND THE INCLUSION OF
SOCIAL AND BEHAVIORAL EFFORTS IN
OUR STUDY DESIGN AND CLINICAL
ASSESSMENT.
CERTAINLY SPECIFIC TO LONG COVID
WHERE THESE ARE -- IT'S OBVIOUS
THEY ARE ABSOLUTELY CRITICAL BUT
ALSO AS WE APPLY THEM TO OTHER
KEY INITIATIVES, FOR EXAMPLE,
CARE FOR HELP AND DATA
COLLECTION.
A FRAMEWORK FOR RESPONSIBLY
ADVANCING RESEARCH WHILE WE
BUILD TRUST IN SCIENCE, BOTH
THROUGH OUTREACH OF REALLY BROAD
COMMUNITIES, ACADEMIC, INDUSTRY,
COMMUNITIES, PEOPLE WITH LIVED
EXPERIENCE FROM JUNIOR TO MOST
SENIOR RESEARCHERS, ALL OF THESE
ARE ENCOMPASSED BY THE
FRAMEWORK.
WE CARE DEEPLY ABOUT THE
EXPERIENCES WITH EARLY CAREER
NIH RESEARCHERS, I'LL JUST ADD
TO THIS ONE THAT EVERYBODY ASKS
ME WHAT'S THE THING THAT KEEPS
YOU UP MOST AT NIGHT, AND MY
ANSWER IS ALWAYS THE NEXT
GENERATION.
HOW DO WE NURTURE THEM, TAKE
CARE OF THEM, MAKE SURE THEY ARE
READY TO GO SO FAR BEYOND WHAT
WE'VE BEEN ABLE TO DO.
FINALLY BEFORE WE WRAP UP TODAY
I WANT TO THANK OUR WONDERFUL
PRESENTERS, FOR PROVIDING
UPDATES TO EXISTING NIH PROGRAMS
AND HIGHLIGHTING UP AND COMING
RESEARCH AND INITIATIVES.
AND THEN FINALLY THANK YOU TO
ALL OF YOU WHO STUCK WITH US.
WE ALL UNDERSTAND HOW
CHALLENGING A VIRTUAL MEETING IS
FOR SO MANY HOURS, SO WE'RE VERY
GRATEFUL.
WE'LL RESUME THE MEETING AT 9:00
A.M. TOMORROW WHICH IS FRIDAY,
DECEMBER 13.
WITH THAT I'M GOING TO ADJOURN
THE MEETING FOR TODAY.
THANK YOU ALL SO MUCH.
EVERYONE, HAVE A NICE EVENING.