>> GOOD MORNING, EVERYONE.
WELCOME TO OUR FIRST NIH COUNCIL
OF COUNCILS MEETING IN 2025.
I'LL BANG THE GAVEL.
THIS MEETING IS NOW IN SESSION.
I AM NICOLE KLEINSTREUER, ACTING
DPCPSI DIRECTOR, AND IT IS A
PLEASURE TO BE WITH YOU ALL
TODAY AND TO MEET YOU ALL
VIRTUALLY.
AND I LOOK FORWARD TO MEETING
YOU IN PERSON IN OUR NEXT
MEETING.
I'LL INTRODUCE MYSELF AND TELL
YOU A LITTLE MORE ABOUT ME LATER
THIS MORNING.
I AM JOINED HERE BY
DR. FRANZISKA GRIEDER, WHO
SERVES IN THE ROLE OF THE
EXECUTIVE SECRETARY OF THE
COUNCIL OF COUNCILS AND DIRECTOR
OF THE OFFICE OF RESEARCH
INFRASTRUCTURE PROGRAMS.
ADDITIONALLY I WOULD LIKE TO
RECOGNIZE MY DPCPSI COLLEAGUES
IN THE ROOM, GRACE MCCARTHY,
HEALTH SCIENCE POLICY AN HIT OR,
SENIOR SCIENTIFIC ADVISOR TO THE
DPCPSI DIRECTOR, AND PROGRAM
ANALYST AND COUNCIL OF COUNCILS
COORDINATOR.
I WOULD LIKE TO THANK THE
COUNCIL MEETING PLANNING TEAM
MEMBERS FOR ALL OF THEIR WORK IN
SUPPORT OF ALL OF THE COUNCIL
ACTIVITIES.
I WOULD ALSO LIKE TO RECOGNIZE
THE LOGISTICS CONTRACTOR FOR THE
COUNCIL OF COUNCIL, THE
SCIENTIFIC CONSULTING GROUP OR
SCG.
BEFORE WE REALLY GET GOING, LET
ME JUST TURN IT OVER TO FRAN SI
KA TO REMIND OF YOU A FEW
PROCEDURES BEFORE TAKING HOL
CALL TO ENSURE TODAY'S MEETING
RUNS SMOOTHLY.
>> GREAT.
THANK YOU, NICOLE, AND GOOD
MORNING, EVERYBODY.
IT IS GOOD TO SEE YOU AT LEAST
VIRTUALLY ALL TODAY AND ALSO
LOOKING FORWARD TO THE MAY
MEETING WHERE WE WILL ALL BE IN
PERSON.
WE WILL REMIND YOU OF SOME RULES
WHICH WILL HELP TO ENSURE THAT
ALL ARE ABLE TO CONTRIBUTE.
WE ASK YOU TO REMAIN MUTED WHEN
YOU'RE NOT ACTIVELY SPEAKING TO
THE GROUP.
IF YOU WOULD LIKE TO MAKE A
COMMENT OR ASK A QUESTION,
PLEASE USE THE RAISED HAND
FEATURE.
YOU WILL NOTICE TODAY WE'RE ON
TEAMS, THAT'S A LITTLE NEW FOR
ALL OF US, NOT TEAMS IN GENERAL
BUT TEAMS IN COUNCIL.
SO PLEASE USE YOUR RAISED HAND
FEATURE OR ENTER A COMMENT OR
QUESTION DIRECTLY IN THE CHAT
BOX.
ONE OF US WILL CALL ON YOU AND
WE WILL USE THE RAISED HAND
FEATURES FIRST, AND THE CHAT BOX
SECOND.
IF YOU HAVE TECHNICAL
DIFFICULTIES, PLEASE CONTACT
DANIELLE OR ALISON AND CONTACT
INFORMATION IS DISPLAYED ON THE
MONITOR ON THE SLIDE RIGHT NOW.
IF YOU HAVE CHALLENGES OR
PROBLEMS WITH ECB, THE
ELECTRONIC COUNCIL BOOK, PLEASE
CONTACT BATINA VIA CHAT BOX OR
THE NUMBER DISPLAYED AS WELL ON
THE SCREEN.
SO WE WILL NEXT DO ROLL CALL AT
THIS TIME.
WE HAVE DONE THIS MANY TIMES
BEFORE SO YOU'RE WELL AWARE OF
HOW WE ARE DOING THIS.
PLEASE TELL US YOUR NAME,
INSTITUTIONAL AFFILIATION AND
INDICATE IF YOU HAVE SERVED ON A
COUNCIL BEFORE AND WHICH
COUNCIL.
I WILL CALL YOUR NAMES IN
ALPHABETICAL ORDER.
ONCE I CALL YOUR NAME, PLEASE
UNMUTE YOURSELF AND THEN
INTRODUCE YOURSELF.
SO HERE WE GO.
DR. KRISTIN ARDLIE, YOU ARE UP
FIRST DR. ARDLIE.
>> HI, I'M AT THE BROAD
INSTITUTE AND I HAVE NOT SERVED
ON ANY PREVIOUS COUNCILS.
>> THANK YOU, KRISTIN.
DR. LI LINDA CHANG.
>> UNIVERSITY OF MARYLAND IN
BALTIMORE.
I PREVIOUSLY SERVED ON THE BSC
AT NIDA AND ALSO AT THE NIDA
COUNCIL.
THANK YOU.
>> THANK YOU, LINDA.
DR. MONICA GANDHI.
>> YES, I'M DR. MONICA GANDHI,
PROFESSOR OF MEDICINE AT UCSF
AND I PREVIOUSLY SERVED AT NIAID
ADVISORY COUNCIL, INFECTIOUS
DISEASE RESEARCHER.
>> THANK YOU, MONICA.
DR. RAFAEL IRIZARRY.
>> CHAIR OF THE DEPARTMENT OF
DATA SCIENCE AT DANA FARBER
CANCER INSTITUTE, PROFESSOR OF
APPLIED STATISTICS AT HARVARD
SCHOOL OF PUBLIC HEALTH.
I SERVED IN THE COUNCIL FOR THE
NHGRI.
>> THANK YOU, RAFAEL.
DR. KEVIN JOHNSON.
>> GOOD MORNING.
I'M KEVIN JOHNSON.
I'M A UNIVERSITY PROFESSOR HERE
AT THE UNIVERSITY OF
PENNSYLVANIA, PEDIATRICIAN,
RESEARCHER, AND BIOMEDICAL
INFORMATICS PERSON, AND I'VE
PREVIOUSLY SERVED ON THE NCRR
COUNCIL AND ON THE BOARD OF
SCIENTIFIC COUNSELORS FOR THE
NLM.
>> THANK YOU, KEVIN.
DR. KAREN JOH JOHNSTON.
>> HI, KAREN JOHNSTON,
UNIVERSITY OF VIRGINIA AND I
PREVIOUSLY SERVED ON THE NINDS
COUNCIL.
THANK YOU.
>> THANK YOU, KAREN.
BARBARA KELLEY IS NOT WITH US
TODAY.
SHE HAS OTHER OB OBLIGATIONS.
>> YES, I AM.
>> OH, SO SORRY, SO SORRY!
MY INFORMATION IS INCORRECT.
>> IT'S GOOD.
I'M TRAVELING, SO I'M IN AND
OUT.
THANK YOU.
I'M BARBARA KE.
LLEY, EXECUTIVE DIRECTOR OF THE
HEARING LOSS ASSOCIATION OF
AMERICA AND I PREVIOUSLY SERVED
ON THE NIDCD COUNCIL.
>> GREAT.
THANK YOU, BARBARA AND THANK YOU
FOR MAKING THE EFFORT.
DR. JEAN KING.
>DR. KING?
>> DR. KING, PLE PLEASE UNMUTE
YOURSELF AND GO AHEAD.
>> CAN YOU HELP, CHRISTINE?
>> YES, CAN YOU HEAR ME?
I HAVE BEEN TRYING, SORRY.
I HAVE NO IDEA WHY IT'S NOT
WORKING.
>> WE COULD HEAR YOU, DR. KING.
YOU'RE ON MUTE AGAIN.
>> JEAN, LET'S GO TO THE NEXT
PERSON AND I'LL COME BACK TO YOU
AT THE END.
LET'S GO TO DR. RICHARD KRUGMAN
NEXT.
DICK?
>> I'M DICK KRUGMAN,
DISTINGUISHED PROFESSOR OF
PEDIATRICS AT THE UNIVERSITY OF
COLORADO SCHOOL OF MEDICINE.
I WORK AT THE KEMP CENTER FOR
PREVENTION OF CHILD ABUSE AND
NEGLECT.
I WAS ON THE NICHD COUNCIL FOR
FOUR YEARS BEFORE JOINING THIS
ONE.
>> GREAT.
THANK YOU, DICK.
SORRY I WAS OVEREAGER.
NEXT IS DR. KENT LLOYD.
>> GOOD MORNING, EVERYONE.
MY NAME IS KENT LLOYD.
I'M A PROFESSOR IN THE
DEPARTMENT OF SURGERY, ASSOCIATE
DIRECTOR OF COMPREHENSIVE CAN CR
CENTER UNIVERSITY OF CALIFORNIA
DAVIS AND I SERVED ON THIS
COUNCIL OF COUNCILS PREVIOUSLY.
THANK YOU.
>> THANK YOU, KEN.
DR. JENNIFER MANLY.
JENNIFER?
>> DR. MANLY, PLEASE UNMUTE
YOURSELF AND GO AHEAD.
DR. MANL YI,Y, I SEE YOU'RE UNM.
MEELET US KNOW IF YOU ARE HAVING
ISSUES AND WE'LL DO OUR BEST TO
ASSIST.
>> LET'S MOVE OND.
NEXT IS DR. RHONDA
ROBINSON-BEALE.
>> GOOD MORNING.
RHONDA ROBINSON-BEALE,
PSYCHIATRIST BY BACKGROUND, AND
I AM AN SVP AND CHIEF MEDICAL
OFFICER FOR MENTAL HEALTH
SERVICES FOR UNITED HEALTH
GROUP.
I SERVED PRIOR TO THIS COUNCIL
WITH THE NATIONAL ADVISORY
MENTAL HEALTH COUNCIL FOR SIX
YEARS.
>> THANK YOU, RHONDA.
DR. SUSAN SANCHEZ.
>> GOOD MORNING, EVERYBODY.
SUSAN SANCHEZ, PROFESSOR OF
INFECTIOUS DISEASES AT THE
COLLEGE OF VETERINARY MEDICINE
AT THE UNIVERSITY OF GEORGIA AND
I HAVE NOT SERVED ON OTHER
COUNCIL BEFORE THIS ONE.
THANK YOU.
>> THANK YOU, SUSAN.
DR. ANNA MARIA SIEGA-RIZ.
>> YES, GOOD MORNING.
I AM THE DEAN OF THE SCHOOL OF
PUBLIC HEALTH AND HEALTH
SCIENCES AT UMASS AMHURST.
I'M PROFESSOR OF NUTRITION AND
IN THE DEPARTMENT OF
EPIDEMIOLOGY AND BIOSTATISTICS.
I HAVE PREVIOUSLY SERVED ON
NHLBI'S ADVISORY COUNCIL.
>> THANK YOU, ANNA MARIA.
I UNDERSTAND LAUREN SILVIS IS
NOT ON, CORRECT?
YES.
AND THEN THE LAST ONE ON THE
LIST, SORRY, RUSS, DR. RUSS VAN
GELDER.
>> HI, RUSS VAN GELDER,
PROFESSOR AND CHAIR OF
OPHTHALMOLOGY AT UNIVERSITY OF
WASHINGTON IN SEATTLE.
I'VE PREVIOUSLY SERVED ON THE
COUNCIL OF THE NATIONAL EYE
INSTITUTE.
>> THANK YOU, RUSS.
LET'S TRY AGAIN, DR. JEAN KING.
JEAN, CAN YOU HEAR US AND CAN
YOU --
>> I CAN.
>> EXCELLENT.
>> YES, FOR SOME REASON MY
COMPUTER WAS NOT ALLOWING ME TO
UNMUTE MYSELF.
MY NAME IS JEAN KING, I'M THE
PETERSON FAMILY DEAN OF ARTS AND
SCIENCES AT WORCESTER
POLYTECHNIC INSTITUTE, AFFILIATE
FACULTY IN PSYCHIATRY AT UMASS
MEDICAL SCHOOL ALSO IN
WORCESTER, MASS.
AND I SERVED PREVIOUSLY ON NCCIH
COUNCIL.
>> WONDERFUL, THANK YOU.
JEAN, I'M GLAD IT WORKED OUT.
SO LET'S GIVE DR. JENNIFER MANLY
ANOTHER TRY.
JENNIFER?
MAYBE WE'LL TRY ANOTHER TIME,
JENNIFER, AND WE ARE GLAD YOU
ARE HERE AND WE HOPE YOU CAN
HEAR US AND THEN HOPEFULLY YOU
CAN CONTRIBUTE IN SOME WAY.
WITH THAT, LET ME MOVE ON TO A
FEW MORE ANNOUNCEMENTS THAT I
HAVE TO MAKE TO GET US GOING.
MEETING MATERIALS WERE SENT TO
YOU FOR THIS MEETING ON
APRIL 16TH.
YOU RECEIVED THOSE MATERIALS VIA
EMAIL.
AS MEMBERS OF THIS COUNCIL, YOU
ARE SPECIAL GOVERNMENT
EMPLOYEES, AND, THEREFORE,
SUBJECT TO THE RULES OF CONDUCT
THAT APPLY TO ALL FEDERAL
EMPLOYEES.
THESE RULES AND REGULATIONS ARE
EXPLAINED IN A REPORT WHICH IS
ENTITLED STANDARDS OF ETHICAL
CONDUCT FOR EMPLOYEES OF THE
EXECUTIVE BRANCH AND YOU
RECEIVED THAT REPORT WHEN YOU
WERE FIRST APPOINTED TO THIS
COUNCIL.
AT EVERY MEETING IN ADDITION TO
REMINDING YOU ABOUT THE
IMPORTANCE OF FOLLOWING THE
ETHICS RULES, WE ALWAYS LIKE TO
REVIEW THE STEPS THAT WE TAKE
AND ASK YOU TO TAKE TO ENSURE
THAT ANY CONFLICT OF TRL TBEEN
YOUR PUBLIC RESPONSIBILITIES AND
YOUR PRIVATE INTERESTS ARE
IDENTIFIED AND ADDRESSED.
THREE TIMES A YEAR, YOU PROVIDE
US WITH INFORMATION ABOUT YOUR
PERSONAL, PROFESSIONAL, AND
FINANCIAL INTERESTS.
WE USE THIS INFORMATION AS THE
BASIS FOR ASSESSING WHETHER YOU
HAVE ANY REAL, POTENTIAL OR
APPARENT CONFLICT OF INTEREST.
THAT COULD COMPROMISE YOUR
ABILITY TO BE OBJECTIVE IN
GIVING ADVICE DURING COUNCIL
MEETINGS.
IF SUCH CONFLICTS ARE
IDENTIFIED, WE EITHER ISSUE A
WAIVER OR RECUSE YOU FROM A
PORTION OF THE MEETING.
WE ALSO RELY TO A GREAT DEGREE
ON YOU TO BE ATTENTIVE DURING
OUR MEETING TO THE POSSIBILITY
THAT IF AN ISSUE ARISES THAT
COULD AFFECT OR APPEAR TO AFFECT
YOUR INTERESTS IN A SPECIFIC
WAY.
IF THAT HAPPENS, WE ASK YOU TO
RECUSE YOURSELF FROM THE
DISCUSSION, AND BECAUSE THIS IS
A VIRTUAL MEETING, YOU WILL BE
PLACED IN A WAITING ROOM AFTER
YOU TELL US IN THE CHAT THAT
THERE IS A CONFLICT.
IF YOU HAVE ANY QUESTIONS ABOUT
THE RULES OF CONDUCT OR
CONFLICTS OF INTEREST, YOUR
COMMITTEE OR OUR COMMITTEE
MANAGEMENT SPECIALIST, HER NAME
IS FAITH MACK AND YOU HAVE
INTERACTED WITH HER MANY TIMES
BEFORE OR I WILL BE GLAD TO
ADDRESS YOUR CONCERNS.
FOR TODAY'S MEETING, TIME IS
ALLOCATED IN THE AGENDA FOR
DISCUSSIONS BY THE COUNCIL.
WITH
THE COUNCIL BUT UNFORTUNATELY
THERE'S LIMITED TIME FOR ANY
COMMENTS FROM OTHERS FROM OTHER
ATTENDEES.
THE PUBLIC IS WELCOME TO SUBMIT
COMMENTS IN WRITING AFTER THE
MEETING.
INSTRUCTIONS FOR DOING SO ARE IN
THE FEDERAL REGISTER NOTICE THAT
WAS PUBLISHED FOR THIS MEETING
ON MARCH 25.
APPROVED MINUTES WILL BE POSTED
ON THE DPCPSI WEBSITE, AND WITH
REGARD TO FUTURE MEETING DATES,
THERE ARE THREE WAYS HOW YOU CAN
GET THOSE DATES.
THEY ARE ALWAYS LISTED ON YOUR
AGENDA, THEY ARE ALWAYS LISTED
ON THE DPCPSI WEBSITE AND OF
COURSE YOU CAN ALWAYS EMAIL ME
AND I WILL TELL YOU WITH A
REMINDER.
LET ME REMIND YOU AGAIN OF THE
MICROPHONES.
NICOLE TOLD YOU, I TOLD YOU, THE
MEETING IS BEING RECORDED AND
WILL BE TRANSCRIBED.
PLEASE UNMUTE YOURSELF WHEN YOU
SPEAK AND IDENTIFY YOURSELF.
ALSO PLEASE MUTE YOURSELF AFTER
YOU HAVE FINISHED SO OTHERS CAN
TURN THEIR MICROPHONES ON.
PLEASE NOTE THAT THE HOST OF THE
MEETING CAN CONTROL YO YOUR
MICROPHONE AS WELL IN CASE YOU
HAVE FORGOTTEN TO TURN YOURSELF
OFF.
AND REMINDER TO TURN ON YOUR
VIDEOS AND CAMERAS IF YOU ARE
SPEAKING.
IF YOU NEED ANY ASSISTANCE, THE
CHAT FUNCTION IS A GOOD WAY TO
GET ASSISTANCE.
DON'T MAYBE SEND REQUESTS TO
EVERYBODY, YOU ALWAYS CAN
ADDRESS VERY SPECIFIC PEOPLE.
SO FINALLY, CLOSED SESSION WILL
BE HELD FROM 12:15 TO
1:00 TODAY.
IN ATTENDANCE -- IN ACCORDANCE
WITH NIH AND FEDERAL POLICY,
ATTENDANCE IS RESTRICTED TO
COUNCILMEMBERS AND RELEVANT NIH
STAFF.
FOLLOWING THE CLOSED SESSION, WE
HAVE A BRIEF BREAK FOR LUNCH AND
WE WILL RESUME THE OPEN SESSION
AT 1:15.
ARE THERE ANY QUESTIONS AT THIS
TIME?
I'M NOT SEEING ANY QUESTIONS,
THEREFORE, I'LL TURN THE
MICROPHONE BASS OVER TO YOU.
>> THANK YOU, FRAN CHESS THAT.
FRANZISKA.
I WOULD LIKE TO REPEAT THAT WE
ARE IN OPEN SESSION OF TODAY'S
MEETING WHICH MEANS OPEN TO THE
PUBLIC, INCLUDING MEMBERS OF THE
PRESS.
WE ARE VIDEOCASTING THIS MEETING
SO ALL INTERESTED PARTIES CAN
LISTEN.
ALL RIGHT.
LET'S KICK THINGS OFF.
WE HAVE A VERY PACKED AGENDA,
CERTAINLY IF YOU NEED TO STEP
AWAY FOR A MINUTE, WE DO
UNDERSTAND.
SO AFTER I PROVIDE SOME DPCPSI
UPDATES, OUR AGENDA WILL INCLUDE
REMARKS FROM THE NIH DIRECTOR,
DR. BHATTACHARYA, FOR CONCEPT
CLEARANCES, NOT IN THAT ORDER
ACTUALLY, FIRST SOME CONCEPT
CLEARANCE, THEN LATER IN THE DAY
REMARKS FROM OUR NEW NIH
DIRECTOR.
WE WILL ALSO HAVE A PRESENTATION
ON A COUNCIL OF COUNCIL WORK
GROUP ON SCIENCE OF SCIENCE, AND
WE WILL CLOSE OUT THE DAY WITH
REFLECTIONS FROM OUR DEPARTING
COUNCILMEMBERS.
SO AS YOU KNOW, THE DIRECTORS OF
EACH OF THE DPCPSI PROGRAM
OFFICES SERVE AS NON-VOTING
LIAISONS TO THE COUNCIL.
THEY ARE LISTED HERE WITH THEIR
PHOTOS ON THIS SLIDE, AND THEY
ARE ALSO ON THE CALL AND
AVAILABLE FOR INPUTS OR COMMENTS
IF NEEDED.
I WANT TO TAKE A MOMENT TO NOTE
THAT STEFFAN PASIOKAS LEFT FOR
AN OPPORTUNITY TO ACADEMIA AND
DREW BREMER, DIRECTOR OF THE
OFFICE OF NUTRITION RESEARCH HAS
KINDLY AGREED TO TEMPORARILY
SERVE AS THE ACTING DIRECTOR OF
ODS.
ALSO IN ALIGNMENT WITH THE
ADMINISTRATION'S EXECUTIVE ORDER
ON DEFENDING WOMEN FROM GENDER
ETIOLOGY EXTREMISM AND RESTORING
BIOLOGICAL TRUTH TO THE FEDERAL
GOVERNMENT, NIH IS TERMINATING
GROUPS THAT DO NOT ALIGN WITH
THAT E.O.
THIS INCLUDES THE SEXUAL AND
GENDER MINORITY RESEARCH OFFICE
IN DPCPSI AND THE COUNCIL OF
COUNCIL'S SEXUAL AND GENDER
MINORITY RESEARCH WORKING GROUP.
WE WILL NOTIFY THE WORKING GROUP
MEMBERS FOLLOWING THIS MEETING
OF THE DISSOLUTION OF THE
WORKING GROUP.
SO NOW TO TURN TO THE DPCPSI
UPDATES, SO I WANT TO START BY
ANNOUNCING SOME EXCITING
ADDITIONS TO DPCPSI.
FIRST MYSELF ALTHOUGH THAT'S
LESS EXCITING THAN THE NEXT
SLIDE BUT JUST TO SAY HELLO AND
INTRODUCE MYSELF TO ALL OF YOU.
I WAS PRIVILEGED TO BE APPOINTED
THE ACTING NIH DEPUTY DIRECTOR
FOR PROGRAM COORDINATION
PLANNING AND STRATEGIC
INITIATIVES ON APRIL 10TH, SO
JUST UNDER TWO WEEKS AGO.
THAT OF COURSE MEANS THAT I AM
ALSO DIRECTING THE DIVISION FOR
PROGRAM COORDINATION PLANNING
AND STRATEGIC INITIATIVES.
I HAVE BEEN A PART OF NIH FOR
ALMOST 10 YEARS.
I CAME FROM NIEHS, NATIONAL
INSTITUTE FOR ENVIRONMENTAL
HEALTH SCIENCES, THE DIVISION OF
TRANSLATIONAL TOXICOLOGY.
I WAS DIRECTOR OF THE NTP
INTERAGENCY CENTER FOR THE
EVALUATION OF ALTERNATIVE
TOXICOLOGICAL METHODS OR
NICEATM, ALSO DIRECTLY DIRECTOR
OF THE CONGRESSIONAL MANDATED
INTERAGENCY COORDINATING
COMMITTEE FOR THE VALIDATION OF
ALTERNATIVE METHODS WHICH COP
CYCONSISTS OF 18 DIFFERENT FEDEL
AGENCIES INCLUDING NIH AND
SEVERAL INSTITUTES AND CENTERS
WITHIN NIH, AND THERE I WAS
REALLY, REALLY HONORED TO BE
LEADING INTERAGENCY AND
INTERNATIONAL EFFORTS TO DEVELOP
AND VALIDATE WHAT ARE CALLED
NAMs, I'M SURE ALL OF YOU ARE
FAMILIAR WITH THAT TERM, BUT
THEY'RE A NEW APPROACH
METHODOLOGIES.
MY PERSONAL BACKGROUND IS
ACTUALLY IN COMPUTATIONAL
MODELING, BIOMEDICAL
ENGINEERING, ARTIFICIAL
INTELLIGENCE AND SYSTEMS
MODELING, AND SO I'M JUST
REALLY, REALLY EXCITED TO BE IN
THIS POSITION AND TO LEARN MORE
AND MORE ABOUT DPCPSI AND THE
OUTSTANDING WORK THAT'S BEING
DONE ACROSS ALL OF NIH, BOTH
WITHIN THE DPCPSI OFFICES AND
ACROSS ALL OF THE ICs.
OKAY.
MOVING TO THE NECT INEQUITIES NM
VERY PLEASED TO ANNOUNCE THE
FORMAL ADDITION OF THE ALL-OF-US
RESEARCH PROGRAM OFFICE, AND THE
ECHO PROGRAM OFFICE TO DPCPSI.
WE ALSO INTEGRATED THE
MANAGEMENT OF THE INCLUDE
PROJECT INTO THE DPCPSI
DIRECTOR'S OFFICE.
AS YOU ALL ARE PROBABLY AWARE,
DPCPSI HAS INFORMALLY WELCOMED
THEM INTO THE FOLD FOR THE PAST
YEAR SO THAT PROCESS ACTUALLY
STARTED AT THE END OF 2023, BUT
WE'RE VERY EXCITED THAT THESE
TRANSFORMATIVE PROGRAMS ARE NOW
OFFICIALLY IN DPCPSI.
ON SEPTEMBER 24TH, THE OFFICE
AIDS RESEARCH HOSTED THE SECOND
INNOVATION IN AIDS RESEARCH
SYMPOSIUM HELD DURING THE NIH
RESEARCH FESTIVAL.
THIS WAS A HYBRID EVENT.
IT FEATURED INTRAMURAL
INVESTIGATORS WHO RECEIVE
INNOVATION PROGRAM AWARDS WITH
16 PRESENTATIONS COVERING
ASSORTED TOPICS SUCH AS
VIROLOGY, VACCINE DISCOVERY,
DATA SCIENCE, COMORBIDITIES,
COINFECTIONS.
THIS SYMPOSIUM HIGHLIGHTED THE
PROGRAM'S IMPACT IN FOSTERING
INNOVATIVE RESEARCH WITH THE
POTENTIAL TO ADVANCE THE HIV
CARE CONTINUUM.
PARTICIPANTS REMARKED THAT THEY
APPRECIATED THE OPPORTUNITY FOR
NETWORKING AND GAINING INSIGHTS
INTO THE INTRAMURAL HIV RESEARCH
COMMUNITY.
IN DECEMBER OAR HAD A BUS EYE
BUSY ANDE
EXCITING MONTH OF WORLD AIDS
DAY.
OAR HOSTED A WORLD AIDS DAY
VIRTUAL PANEL.
THIS WAS ATTENDED BY OVER 500
PARTICIPANTS, AND THAT'S NOTABLE
BECAUSE IT'S A 42% INCREASE FROM
2023.
SEVERAL OAR STAFF ATTENDED THE
FIRST EVER WHITE HOUSE DISPLAY
OF THE AIDS QUILT, TWO
CONGRESSIONAL RECEPTIONS
HONORING THE RETIRING
REPRESENTATIVE BARBARA LEE WHO
CO-CHAIRED AND COFOUNDED THE HIV
CONGRESSIONAL CAUCUS.
ON A SADDER NOTE, THE TEAM PAID
RESPECTS TO MR. CORNELIUS BAKER
WHO WAS AN OAR CONSULTANT AND
LIFELONG HIV ADVOCATE AND HE WAS
LAID TO REST AT THE NATIONAL
CATHEDRAL ON DECEMBER 13TH.
ALSO IN DECEMBER, NIH ANNOUNCED
AWARDS TO ADVANCE TECHNOLOGY FOR
HIV VIRAL LOAD DETECTION, SO
FUNDING AND SUPPORT SERVICES
WERE AWARDED TO THREE DIAGNOSTIC
TECHNOLOGY DEVELOPERS AS PART OF
RADX OR THE RAPID ACCELERATION
OF DIAGNOSTICS.
THESE TECH ADVANCED PLATFORMS
FOR HIV VIRAL LOAD MONITORING
PROGRAM.
SO LAUNCHED IN THE SPRING OF
2024 BY NIBIB IN COLLABORATION
WITH OAR AND NIAID, THIS PROGRAM
IS AIMED AT ADVANCING HIV VIRAL
LOAD DETECTION TECHNOLOGIES FOR
USE AT POINT OF CARE.
SO THE THREE AWARDS THAT ARE
LISTED HERE WERE CEPHE ID IN
CALIFORNIA TO QUANTITATIVELY
DETECT LEVELS OF HIV IN UNDER 90
MINUTES.
BAEBIES, INCORPORATED FROM
DURHAM, NORTH CAROLINA,
OPTIMIZING RT-PCR FOR HIV ASSAY
SENSITIVITY, BLOOD PROCESSING
TECHNIQUES AND VIRAL LOAD
QUANTIFICATION CAPABILITIES, AND
PROMPT TI DIAGNOSTICS IN BALTIM,
MAGNETOFLUIDIC CARTRIDGE
PLATFORM.
THEN ON DECEMBER 17 17THTH, THER
AND FDA CO-HOSTED A JOINT
NIH-FDA NUTRITION REGULATORY
SCIENCE WORKSHOP.
THE GOAL OF THIS JOINT WORKSHOP
IS TO -- WAS REALLY TO HIGHLIGHT
HOW NUTRITION SCIENCE CAN
GENERATE EVIDENCE AND DATA TO
INFORM FOOD-RELATED POLICY AND
REGULATORY DECISION-MAKING AND
TO FOSTER ADDITIONAL
COLLABORATION BETWEEN NIH AND
FDA IN SUPPORTING RESEARCH THAT
ADDRESSES PRIORITY NUTRITION
RESEARCH GAPS.
SO THERE WERE MANY TOPICS THAT
WERE DISCUSSED AT THE WORKSHOP.
THESE INCLUDES ULTRAPROCESSED
FOODS, IMPACT ANALYSIS AND
IMPLEMENTATION SCIENCE RELATED
TO REGULATORY ACTIONS, AND
EMERGING TECHNOLOGICAL
INNOVATIONS RELATED TO NUTRITION
REGULATORY SCIENCE.
AROUND THE SAME TIME, DECEMBER
WAS QUITE A BUSY MONTH, THROW,
THE TRIBAL HEALTH RESEARCH
OFFICE, HELD A 2 1/2 DAY IN
PERSON FEDERAL INDIAN BOARDING
SCHOOL HEALING SUMMIT.
THIS SUMMIT BROUGHT TOGETHER
BOARDING SCHOOL SURVIVORS,
PRACTITIONERS, LEADERS IN TRAUMA
RAO SEARCH AND LEADERS FROM
MULTIPLE NIH ICOs AND FEDERAL
AGENCIES.
THE GOAL HERE WAS TO SHARE
STORIES, IDENTIFY GAPS IN
KNOWLEDGE AND ALIGN PRIORITIES
FOR DEVELOPING INITIATIVES THAT
EMBRACE A WHOLE OF GOVERNMENT
AND COMMUNITY INFORMED APPROACH
TO ADDRESSING BOARDING SCHOOL
AND INTERGENERATIONAL TRAUMA
HEALING.
THEN MOST RECENTLY, ODS HAS
RELEASED THEIR STRATEGIC PLAN
FOR 2025 THROUGH 2029.
THIS STRATEGIC PLAN OUTLINES
THREE PRIMARY GOALS: ADVANCE
RESEARCH, EXPAND CAPACITY AND
FOSTER STEWARDSHIP, THAT WILL
ENABLE ODS TO BUILD
UNDERSTANDING OF HOW DIETARY
SUPPLEMENTS MODULATE RESILIENCE
AND HEALTH ACROSS THE LIFESPAN
IN HETEROGENEOUS POPULATION.
S.
THEN THE COMMON FUND VENTURE
PROGRAM WHICH YOU ALL HEARD
DISCUSSED HERE, A NEW FORM OF
COMMON FUND SUPPORT IS ACTUALLY
PROVIDING A FRAMEWORK TO DEVELOP
SHORT-TERM PROJECTS WITH THE
POTENTIAL FOR SIGNIFICANT
OUTSIZED IMPACT HAS RECENTLY
LAUNCHED ITS TWO INITIATIVES.
SO THE FIRST OF THESE
INITIATIVES IS AN EFFORT TO
INTEGRATE VARIOUS DATA TYPES
THAT ALLOW RESEARCHERS TO
EXPLORE THE ROLE OF A SPECIFIC
GENE, MOLECULE, CELL OR PATHWAY
ACROSS TISSUES INVOLVED IN
DIFFERENT DISEASE.
AND OCULOMICS, TO DEVELOP AND
APPLY NOVEL NONINVASIVE EYE
IMAGING TECHNOLOGIES, MACHINE
LEARNING ALGORITHMS AND OTHER
TOOLS TO IDENTIFY HIGHLY
SENSITIVE AND SPECIFIC
BIOMARKERS FOR DISEASES THAT
AFFECT THE ENTIRE BODY.
SO BOTH INITIATIVES MADE AWARDS
AND HELD KICKOFF MEETINGS.
THEN ODP IS PARTNERING WITH THE
CDC'S OFFICE ON SMOKING AND
HEALTH TO SPONSOR THE QUIT AND
THRIVE CHALLENGE,
COMMUNITY-DERIVED SOLUTIONS TO
REDUCE MENTHOL CIGARETTE
SMOKING.
SO THE GOAL OF THIS CHALLENGE
WAS TO SHOWCASE COMMUNITY
GENERATED SOLUTIONS THAT HAVE
REDUCED MENTHOL CIGARETTE
SMOKING AMONG GROUPS WITH
DISPROPORTIONATELY HIGH RATES OF
USE, AND OF COURSE THAT INCLUDES
YOUTH AND MINORITIES AND PEOPLE
WITH LOWER INCOMES.
THESE SOLUTIONS MAY BE USED TO
INFORM FUTURE FEDERALLY FUNDED
RESEARCH INITIATIVES OR
DEMONSTRATION PROJECTS.
UP TO NINE PRIZES OF $100,000
EACH WILL BE AWARDED TO WINNING
ORGANIZATIONS IN JULY OF 2025.
SO I REALLY WISH THAT I HAD MORE
TIME TO CONTINUE SHARING ALL OF
THE WONDERFUL PROGRESS AND
UPDATES WE HAVE AS A DIVISION,
BUT I WILL HAVE TO STOP FOR NOW
SO THAT WE CAN GET TO THE REST
OF OUR AGENDA.
OF AND SO THESO THE LAST THING Y
BEFORE WE MOVE INTO THE CONCEPT
CLEARANCES IS THAT DPCPSI IS
ACTUALLY LEADING DEVELOPMENT OF
THE AGENCY-WIDE NIH STRATEGIC
PLAN FOR DISABILITY HEALTH
RESEARCH.
SO THIS IS A PROSPECTIVE EFFORT
THAT WE'RE UNDERGOING THE
PLANNING AND DEVELOPMENT PROCESS
FOR RIGHT NOW.
SO THROUGH THE NIH DISABILITY
HEALTH RESEARCH COORDINATING
COMMITTEE, WE BROUGHT TOGETHER
SUBJECT MATTER EXPERTS FROM 24
ICs AND 18 OFFICES AND
PROGRAMS TO SHARE RESEARCH
ADVANCES AND COLLABORATE.
WE ALSO HOSTED SIX COMMUNITY
ROUNDTABLE DISCUSSIONS AND A
PUBLIC TOWN HALL TO GAIN
INSIGHTS FROM PEOPLE WITH
DISABILITIES, RESEARCHERS AND
CLINICIANS AND PROFESSIONAL
ASSOCIATIONS AND ADVOCACY
ORGANIZATIONS, AND THEN WE ALSO
PUBLISHED AN RFI TO OBTAIN
PUBLIC FEEDBACK ON THE DRAFT
FRAMEWORK FOR THE STRATEGIC PLAN
AND WE RECEIVED OVER 140
RESPONSES TO THAT.
SO THE STRATEGIC PLAN WILL BE
RELEASED LATER THIS YEAR AND
AFTER THIS MEETING, WE WILL BE
SENDING INVITATIONS TO THE
COUNCIL OF COUNCILS DISABILITY
HEALTH RESEARCH WORKING GROUP.
OKAY.
SO NOW WE WILL BE MOVING INTO
THE CONCEPT CLEARANCE PORTION OF
THE AGENDA.
FIRST UP WE HAVE A CONCEPT
CLEARANCE FROM THE OFFICE OF
RESEARCH INFRASTRUCTURE PROGRAMS
OR ORIP.
DR. RITESH TANDON, PROGRAM
DIRECTOR IN THE DIVISION OF
COMPARATIVE MEDICINE IN ORIP,
WILL PRESENT A REISSUE OF THE
CONCEPT ENTITLED LIMITED
COMPETITION, SMALL GRANT PROGRAM
FOR ORIP SPECIAL EMPHASIS CAREER
RESEARCH AWARD OR SERCA.
THIS PRESENTATION WILLING
FOLLOWED I ABOUT TWO ASSIGNED
COUNCILMEMBER DISCUSSANTS,
DR. SUSAN SANCHEZ AND DR. MONICA
GANDHI.
RITESH, OVER TO YOU.
>> GOOD MORNING.
CAN YOU ALL HEAR ME?
YES, THANK YOU.
>> WE CAN'T HEAR YOU NOW.
>> OKAY.
CAN YOU HEAR ME NOW?
>> YES.
>> OKAY.
CAN YOU SEE MY CAMERA?
>> NO.
>> NO?
OKAY.
>> SORRY TE SO RITESH, IT LOOKSR
CAMERA IS BLACKED OUT.
I DON'T KNOW IF IT'S TECHNICAL
ISSUES OR A MATTER OF SWITCHING
IT ON.
I GET FROM MY TECHNICAL
COLLEAGUES HERE A NODDING THAT
IT PROBABLY JUST A TECHNICAL
ISSUE.
SO WHY DON'T YOU JUST PRESENT
AND WE JUST WON'T SEE YOU WHILE
YOU'RE PRESENTING.
THAT MAKES MORE SENSE TO ME.
>> WE CAN SEE NOW.
>> OKAY, GREAT.
>> NOW WE CAN SEE YOU.
>> GREAT.
THANK YOU SO MUCH.
SO GOOD MORNING, EVERYONE.
I WOULD LIKE TO BRIEFLY
INTRODUCE FOR THE CONCEPT
CLEARANCE THE REISSUE OF THE
UNIQUE SMALL GRANT PROGRAM FOR
ORIP VETERINARY SCIENTIST
SPECIAL EMPHASIS RESEARCH CAREER
AWARD, SERCA K01 RECIPIENTS
USING THE R03 MECHANISM.
THE OBJECTIVE OF THIS PROGRAM IS
TO FACILITATE SERCA
K01 RECIPIENTS' TRANSITION TO
INDEPENDENCE BY ELEVATING
FINANCIAL IND AGAINST, KEM
DEMONSTRATING ADDITIONAL SUCCESS
IN PEER REVIEW COMPETITIONS AND
GENERATING ADDITIONAL DATA AND
PUBLICATIONS IN SUPPORT OF
FUTURE R01 OR EQUIVALENT GRANT
APPLICATIONS.
THE FUNDS AVAILABLE AND THE
ANTICIPATED NUMBER OF AWARDS FOR
THIS PROGRAM ARE CONTINGENT UPON
NIH APPROPRIATIONS AND HOW MANY
MERITORIOUS APPLICATIONS ARE
SUBMITTED IN A GIVEN CYCLE.
THE AWARD PROJECT PERIOD IS FOR
TWO YEARS.
AND THE COUNCIL ACTION THAT WILL
BE UNDER DISCUSSION IS A VOTE
FOR CONTINUED SUPPORT OF THE
SMALL GRANT PROGRAM FOR ORIP
VETERINARY SCIENTIST SERCA
K01 RECIPIENTS.
TO GIVE YOU SOME BACKGROUND ON
ORIP'S R03 PROGRAM, ORIP
SUPPORTS SERCA K01 GRANTS UNDER
THE MENTORED RESEARCH SCIENTIST
AWARD PARENT K01 FOR DEVELOPING
VETERINARY SCIENTISTS.
THE PROGRAM IS UNIQUE AT NIH
BECAUSE IT SPECIFICALLY SUPPORTS
VETERINARY SCIENTISTS AND
PROVIDES MENTORED EXPERIENCE TO
HELP EARLY STAGE VETERINARY
SCIENTISTS TRANSITION INTO
INDEPENDENT INVESTIGATORS
FOCUSING ON COMPARATIVE
MEDICINE, BIOMEDICAL RESEARCH,
AND TRANSLATIONAL SCIENCES.
VETERINARY SCIENTISTS BRING
UNIQUE KNOWLEDGE OF COMPARATIVE
BIOLOGY THAT IS IMPORTANT FOR
THE DEVELOPMENT AND REFINEMENT
OF ANIMAL MODELS OF HUMAN
DISEASES, AS WELL AS
RECOMMENDATIONS ON ALTERNATIVES
TO ANIMAL MODELS.
THE TRANSITION FROM K GRANT TO R
GRANT IS A CRITICAL CAREER
JUNCTURE.
RECOGNIZING THE CHALLENGES OF
THIS PHASE, SEVERAL NIH
INSTITUTES HAVE SUCCESSFULLY
USED LIMITED COMPETITION
R03 GRANT PROGRAM TO SUPPLEMENT
THE CAREER DEVELOPMENT OF THEIR
K GRANT RECIPIENTS DURING THE
LAST TWO GRANT AWARD YEARS.
THE INTENT OF THESE R03 PROGRAMS
IS TO INCREASE THE SUCCESS RATE
OF NEW INVESTIGATORS BY APPLYING
FOR R01 OR EQUIVALENT GRANTS,
WHICH HAS BEEN SHOWN BY OTHER
PROGRAMS.
ORIP ESTABLISHEDDITY OWN
R03 PROGRAM FOR SERCA
KO1 RECIPIENTS.
THIS PROGRAM ENHANCES THE
ABILITY OF AWARDEES TO CONDUCT
RESEARCH AS THEY TRANSITION TO
BECOMING INDEPENDENT
RESEARCHERS, AND ALIGNS WITH
ORIP'S MISSION TO SUPPORT
RESEARCH TRAINING OPPORTUNITIES
FOR VETERINARY SCIENTISTS.
SINCE JUNE 2017, 3 NOTICES OF
FUNDING OPPORTUNITIES OR NOFOs
HAVE BEEN ISSUED AND ARE LISTED
HERE.
I SHOULD MENTION THAT THE NOFO
WAS RECENTLY REISSUED AT THE END
OF MARCH TO ALIGN WITH
ADMINISTRATIVE PRIORITIES.
A SINGLE AND -- DEADLINE -- THAT
LEFT MANY APPLICANTS WITH LITTLE
OR NO CHANCE OF BEING ELIGIBLE
TO SUBMIT AN APPLICATION IF THE
ORIGINAL APPLICATION WAS NOT
FUNDED.
ESPECIALLY CONSIDERING THESE ARE
TRAINEES EAGER TO MOVE ON TO
THEIR NEXT CAREER STAGE, THE
PROGRAM CHANGED THE DEADLINE TO
THREE TIMES A YEAR STARTING WITH
THE 2023 NOFO.
THE ORIP R03 PROGRAM ALIGNS WITH
STRATEGY 3.1 OF THE STRATEGIC
PLAN 2021-2025 WHICH PROMOTES
INOINNOVATING APPROACHES TO
TRAINING AND DEVELOPMENT WORKING
IN BIOMEDICAL RESEARCH,
INVESTING AND SUPPORTING THE
CAREER DEVELOPMENT AND TRAINING
THAT PREPARES GRADUATE
VETERINARIANS TO PURSUE RESEARCH
THAT FILLS MAJOR GAPS IN
BIOMEDICAL AND BIOBEHAVIORAL
SCIENCE AND EXPANDS KNOWLEDGE IN
EMERGING AREAS CRITICAL TO HUMAN
HEALTH.
THIS R03 PROGRAM PROVIDES ACCESS
TO RESEARCH SUPPORT THAT ALLOWS
EARLY STAGE VETERINARY
SCIENTISTS TO PURSUE UNIQUE
RESEARCH DIRECTIONS, INDEPENDENT
OF THE FUNDING SUPPORT OF THEIR
MENTORS, FACILITATE THEIR
TRANSITION TO INDEPENDENCE, AND
INCREASE THEIR COMPETITIVENESS
FOR R01 OR EQUIVALENT GRANTS.
THE PROPOSED R03 PROGRAM
INITIATIVE IS INTENDED TO
SUPPORT RESEARCH PROJECTS THAT
CAN BE CARRIED OUT IN A SHORT
PERIOD OF TIME, WITH LIMITED
RESOURCES AND THAT MAY PROVIDE
PRELIMINARY DATA TO SUPPORT A
SUBSEQUENT R01 OR EQUIVALENT
APPLICATION.
PROJECTS THAT WOULD BE SUPPORTED
INCLUDE PILOT AND FEASIBILITY
STUDIES, SECONDARY ANALYSES OF
EXISTING DATA, A SMALL,
SELF-CONTAINED RESEARCH
PROJECTS, DEVELOPMENT OF
RESEARCH METHODOLOGY, AND
DEVELOPMENT OF NEW RESEARCH
TECHNOLOGY.
ORIP'S R03 PROGRAM IS LIMITED TO
SERCA KO1 AWARDEES WHO ARE
ELIGIBLE AFTER COMPLETION OF THE
FIRST TWO YEARS OR 24 MONTHS OF
THEIR K31 AWARD.
HOWEVER, THEY ARE INELIGIBLE IF
THEY ALREADY SUCCESSFULLY
COMPETED FOR AN R01 OR
EQUIVALENT AWARD.
THE SERCA KO1 AWARD MUST BE
ACTIVE.
AWARDEES MAY RECEIVE FUNDING FOR
ONLY ONE RSM 03 GRANT AWARD AND
R03 APPLICANT CAN REQUEST A
BUDGET UP TO $150,000 IN DIRECT
COSTS FOR UP TO TWO YEARS.
THE PROGRAM HAS ACHIEVED NOTABLE
SUCCESS SINCE BEING ESTABLISHED.
WITH THE FIRST NOFO BEING
RELEASED IN FISCAL YEAR 2017,
FOLLOWED BY RECEIPT OF THE FIRST
ROUND OF APPLICATIONS ELIGIBLE
FOR SUBMISSION IN FISCAL YEAR
2018.
13 R03 AWARDS WERE MADE BETWEEN
2019 AND 2024 FROM AMONG
42 APPLICATIONS SUBMITTED
BETWEEN FISCAL YEAR 2018 TO
2024.
THIS IS A 31% AWARD RATE.
IN FISCAL YEAR 2025, SEVEN OF
THE 13 GRANTEES HAD ALREADY
APPLIED FOR NIH R01 GRANTS WHILE
THREE GRANTEES HAVE ALREADY BEEN
AWARDED R01 GRANTS.
AFTER RECEIVING R03 GRANTS,
SEVEN GRANTEES HAVE ADVANCED IN
FOLLOWING YEARS TO THE RANK OF
ASSOCIATE PROFESSOR AND ONE
GRANTEE TO ASSISTANT PROFESSOR.
THE REMAINING GRANTEES HAVE
MAINTAINED THEIR POSITIONS WITH
FOUR GRANTEES IN ASSISTANT AND
ONE AS ASSOCIATE PROFESSOR.
THE 13 GRANTEES COLLECTIVELY
HAVE 16 PUBLICATIONS, 13
RESEARCH, ONE REVIEW, AND TWO
CLINICAL ARTICLES, ASSOCIATED
WITH THE R03 GRANTS.
15 OF THESE PUBLICATIONS ARE
SENIOR AUTHOR PUBLICATIONS,
INDICATING THE INDEPENDENT
STATUS OF AWARDEES.
AN ANALYSIS OF THE TRANSLATIONAL
IMPACT OF THESE PUBLICATIONS WAS
DONE USING EYESIGHT, A TOOL
DEVELOPED WITHIN THE OFFICE OF
THE NIH DIRECTOR.
THIS TOOL GENERATES A
TRANSLATIONAL PYRAMID SHOWING
ARTICLE DENSITY BETWEEN HUMAN,
ANIMAL AND MOLECULAR CELLULAR
VERTICES.
WITH RED AND WARMER COLORS
REFLECTING A HIGH ARTICLE
DENSITY WHILE BLUE OR COOLER
COLORS REFLECT LOW ARTICLE
DENSITY.
AS SHOWN IN THE FIGURE TO YOUR
RIGHT, PUBLICATIONS FROM THESE
AWARDS CLUSTER BETWEEN ANIMAL
ORIENTED RESEARCH AND MOLECULAR
CELLULAR RESEARCH.
INDICATING THAT THE AWARDS
PRIMARILY SUPPORTED
PRETRANSLATIONAL RESEARCH.
AND UPWARD MOVEMENT TO
TRANSLATIONAL RESEARCH IS
EXPECTED AS AWARDEES PROGRESS
FURTHER IN THEIR CAREER.
THE PROGRAM'S OUT COME
DEMONSTRATES ITS EFFECTIVENESS
IN SUPPORTING SERCA AWARDEES IN
THEIR RESEARCH CAREERS.
FOR THIS CONCEPT CLEARANCE TO
ADDRESS THE NEED FOR ONGOING
TRANSITION SUPPORT BETWEEN
KO1 AND R01 REPORT FOR
VETERINARY SCIENTISTS, REQUEST
FOR ISSUE OF A SMALL GRANT
PROGRAM FOR ORIP VETERINARY
SCIENTISTS K01 RECIPIENTS USING
THE R03 MECHANISM.
I'M HAPPY TO ANSWER ANY
QUESTIONS DURING THE DISCUSSION.
THANK YOU SO MUCH.
>> THANK YOU, RITESH.
DR. SANCHEZ, WOULD YOU PLEASE
SHARE ANY COMMENTS WITH THE
COUNCIL?
>> THANK YOU VERY MUCH,
DR. TANDON.
I HOPE EVERYBODY CAN HEAR ME.
IS THAT CORRECT?
>> YES, WE CAN.
>> EXCELLENT.
SO THE NATIONAL INSTITUTE OF
HEALTH HAS ALWAYS EMPHASIZED
DEVELOPING A ROBUST PHYSICIAN
SCIENTIST WORKFORCE, INCLUDING
VETERINARY SCIENTISTS.
THIS RECOGNITION ARISES FROM
VETERINARIANS' CRUCIAL ROLE IN
BIOMEDICAL RESEARCH AND THEIR
UNIQUE CONTRIBUTIONS TO
COMPARATIVE MEDICINE.
PROPORTION OF RESEARCH AWARD USE
ANIMALS.
VETERINARIANS ARE UNIQUELY
POSITIONED TO REFINE, REDUCE AND
IMPROVE THESE MODELS, AND YET
THERE ARE MINUSCULE PORTION OF
NIH FUNDED SCIENTISTS.
NIH HAS IMPLEMENTED VERY
STRINGENT CAREER DEVELOPMENT
PROGRAMS TO SUPPORT VETERINARY
SCIENTISTS AT DIFFERENT STAGES
OF THEIR CAREER.
THE OFFICE OF RESEARCH
INFRASTRUCTURE PROGRAMS SUPPORTS
THE SPECIAL EMPHASIS -- SERCA
THROUGH THE K01 MECHANISM.
THESE AWARDS AIM TO ENABLE THESE
INDIVIDUALS TO BECOME
COMPETITIVE FOR ACADEMIC
RESEARCH CAREERS AS
INDEPENDENTLY FUNDED BIOMEDICAL
SCIENTIST.
THESE AWARDS EMPHASIZE IN DEPTH
RESEARCH EXPERIENCE FOR UP TO
FOUR YEARS IN VARIOUS BASIC
PRE-CLINICAL AND TRANSLATIONAL
SCIENTIST SUPPLEMENTS.
THE FOCUS AREAS INCLUDE --
ANIMAL MODELS THAT IDENTIFY,
DEVELOP AND CHARACTERIZE BOTH
SPONTANEOUS AND ENGINEERED
ANIMAL MODELS TO ENHANCE THE
UNDERSTANDING OF HUMAN DISEASES.
UNFORTUNATELY TRANSITION FROM A
TRAINING GRANT TO AN R01 AWARD
IS DIFFICULT AS OBTAINING
PRELIMINARY DATA IS ALSO LIMITED
TO THE LABORATORY FOR TRAINING.
TO BETTER PREPARE VETERINARY
SCIENTISTS TO REALIZE THEIR TRUE
INDEPENDENCE AND RECEIVE FUNDING
FOR THEIR RESEARCH AND TO
MAINTAIN THE LABORATORY, ORIP
HAS IN 2017 OFFERED A SMALL
GRANT PROGRAM, THE R01 AWARDS
FOR WHICH ONLY SERCA RECEIVED --
CAN APPLY AFTER COMPLETING 24
MONTHS OF THE RESEARCH UNDER
THIS AWARD.
THE R01 DURATION IS ONLY TWO
YEARS AND FUNDING IS LIMITED TO
NO MORE THAN $150,000 OVER THIS
PERIOD.
THE SMALL GRANT AWARDS AIM TO
ENHANCE THE ABILITY OF VET NARAF
VETERINARY SCIENTISTS AS THEY
TRANSITION TO BECOMING FULLY
FLEDGED INDEPENDENT
INVESTIGATORS.
IT HELPS IMPROVE THEIR ABILITY
TO OBTAIN FURTHER FUNDING IN THE
FORM OF AN R01 OR EQUIVALENT.
IT IS ESSENTIAL TO EVALUATE
METRICS AND ASSESS THE SUCCESS
OF THE PROGRAM AS IT STANDS.
THE FUNDING OF THIS AWARD
THROUGH IMPLEMENTATION HAS BEEN
31% WHICH IS VERY GOOD,
R03 RECIPIENTS, THREE HAVE
OBTAINED ALREADY R01, WHICH IS
ALREADY A 23% SUCCESS RATE, AND
SEVERAL MORE HAVE R OH 1s
CURRENTLY UNDER REVIEW.
THIS IS A SIGNIFICANT
ACHIEVEMENT IN THE CURRENT
CLIMATE AND DESPITE THE
PANDEMIC.
IN ADDITION, THE NUMBER OF PUBL
PUBLICATIONS IS REASONABLE, 16,
WE ARE AWARE OF THE TIME IT
TAKES TO PRODUCE DATA AND THEN
WRITE WHILE AT THE SAME TIME
PREPARING AND WRITING YOUR NEXT
BIG GRANT, THE R01.
THE MANUSCRIPT TOPICS MESH
PERFECTLY WITH THOSE AWARDED BY
THOSE -- WITH THOSE AWARDS THEY
SUPPORT WHICH INCLUDE ANIMAL
ORIENTED AND MOLECULAR CELLULAR
RESEARCH.
-- ESSENTIAL IN BIOMEDICAL
RESEARCH.
THEY NOT ONLY BRING THE
SCIENTIFIC KNOW-HOW BUT ALSO
CONTRIBUTE WITH THEIR UNIQUE
EXPERTISE AND UNDERSTANDING OF
ANIMAL HEAL HEALTH AND WELFARE O
ENSURE THAT RESEARCH IS
CONDUCTED ETHICALLY AND
EFFECTIVELY, LEADING TO
ADVANCEMENTS IN HUMAN HEALTH.
IF WE EVER ENVISION A TIME WHERE
WE HAVE IN VITRO MODELS AND
COMPUTER PROGRAMMERS THAT
REPLACE THE USE OF LIVE ANIMALS
FOR OUR RESEARCH, VETERINARY
SCIENTISTS LIKE THIS THROUGH
THIS MECHANISM.
YOU FULLY SUPPORT THIS CONCEPT.
IF ANYTHING, THE NUMBER OF
AWARDS SHOULD BE INCREASED.
THANK YOU.
>> THANK YOU, SUSAN.
DR. GANDHI, WOULD YOU LIKE TO
ADD ANY COMMENTS?
>> YES.
SO I THINK THE SUPPORTIVE EARLY
STAGE INVESTIGATORS, ESPECIALLY
AT THIS POINT IN HISTORY WHERE
THERE'S A CONCERN ABOUT SUPPORT
OF EARLY STAGE INVESTIGATORS IS
THE MOST IMPORTANT THING WE
COULD BE DOING AT THE NIH.
SO I REALLY SUPPORT ANYTHING
THAT ALLOWS TRANSITION FROM K TO
R GRANTS.
THIS IS SOMEWHAT UNUSUAL IN THE
SENSE THAT R03s ARE AT OTHER
INSTITUTIONS, INCLUDING NHLBI,
NIAID AND NIAMS AND NIDDK, BUT
AT LEAST TO MY KNOWLEDGE AT
NIAID, IT ISN'T SPECIFICALLY A
BRIDGING MECHANISM FROM A K TO
AN R.
THESE ARE $150,000 GRANTS THAT
CAN BE AWARDED AND APPLIED FOR
OVER TWO YEARS.
AND THIS SEEMS TO BE VERY
SPECIFICALLY FOR THE
VETERINARIAN MEDICINE EARLY
STAGE INVESTIGATORS DURING THEIR
K AWARD.
I THINK IT'S IMPORTANT TO SAY
THAT THEY CAN APPLY EVEN MORE
THAN ONCE, AND AS LONG AS IT'S
NOT AT A NO-COST EXTENSION, THE
APPLICATION CAN OCCUR IN THAT
TIME PERIOD WHERE USUALLY
THERE'S A PREPARATION FOR K TO
R.
THIS DOES HAVE A HIGH SUCCESS
RATE.
THESE ARE, QUOTE, LOW HANGING
FRUITS OR AT LEAST USUALLY
EASIER TO GET IN TERMS OF THE
FUNDING PAYLINES FOR R03s
VERSUS R01s, FOR EXAMPLE, BUT
I THINK ALSO IMPORTANTLY WHAT'S
INCLUDED HERE IN THE
MODIFICATION OF THIS R03 PROGRAM
IS A THREE TIMES YEARLY
APPLICATION PROCESS.
POSSIBILITY WHERE IT USED TO BE
WHERE IT WAS ONLY POSSIBLE TO
APPLY TO THESE ONCE YEARLY.
SO I THINK THAT'S A REALLY
STRONG MODIFICATION TO THE ORIP
SERCA K01 AWARDEE OPPORTUNITY
PRESENTED HERE, AND AGAIN, I
THINK IT'S TIME CERTAINLY AS WE
LOOK ACROSS THE UNIVERSITIES, WE
DEFINITELY WANT TO SUPPORT OUR
EARLY STAGE INVESTIGATORS, THIS
IS THE TIME TO PUT OUT AS MANY
INITIATIVES AS WE CAN TO
ENCOURAGE PEOPLE TO GO INTO NIH
FUNDED RESEARCH.
THANK YOU.
>> THANK YOU VERY MUCH, MONICA.
IF COUNCILMEMBERS HAVE ANY
QUESTIONS OR COMMENTS, PLEASE
RAISE YOUR HAND AND YOU'LL BE
RECOGNIZED BY FRAN SI K FRANZISE
AND UNMUTE YOURSELF.
>> I THINK WE HAVE THE FIRST
QUESTION.
RAFAEL HAS THE FIRST QUESTION.
>> NOT A QUESTION, JUST A
COMMENT TO SUPPORT THIS IC IN MY
INSTITUTION --
[INTERRUPTION]
>> I'M UNMUTED.
>> I THINK WE HAVE THE FIRST
QUESTION --
[ECHOING]
>> RAFAEL, WE CAN HEAR YOU AND
WE HAD THIS WEIRD ECHO.
I COULD RECOGNIZE MY VOICE BUT
IT SOUNDED LIKE --
>> IT'S A PLAYBACK OF THE
LAST --
>> ALL RIGHT.
SO WE ARE GOOD, RAFAEL.
PLEASE, YOUR COMMENT.
>> YEAH, I JUST WANT TO VERY
BRIEFLY LEND MY SUPPORT TO THIS
PROPOSAL.
I SEE THIS IN MY INSTITUTION
WHERE THIS PERIOD IS VERY
DIFFICULT FOR OUR INVESTIGATORS
TO MANAGE SOMETIMES BECAUSE
THERE REALLY IS NO CLEAR
MECHANISM OF HOW TO CONTINUE TO
BE FUNDED, SO I JUST WANTED TO
AGREE WITH THE TWO DISCUSSANTS
THAT IT'S A VERY IMPORTANT THING
TO CONTINUE TO SUPPORT.
THANK YOU.
>> THANK YOU.
ARE THERE ANY OTHER COMMENTS OR
POSSIBLY QUESTIONS?
ALL RIGHT.
I THINK WE CAN MOVE ON.
IF THERE ARE NO OTHER COMMENTS,
YOU ALL HEARD THE MOTION FOR A
VOTE ON THIS CONCEPT.
I THINK BETINA WILL TYPE IT INTO
CHAT AND I WILL CALL FOR THE
VOTE.
MAY I HAVE A MOTION FOR APPROVAL
OF THE ORIP CONCEPT CLEARANCE
ENTITLED LIMITED COMPETITION
SMALL GRANT PROGRAM FOR ORIP
SPECIAL EMPHASIS AWARD CAREER --
I'M SORRY -- SPECIAL EMPHASIS
RESEARCH CAREER AWARD, SERCA,
K01 RECIPIENTS FOR AN R03.
IS THERE SUCH A MOTION?
I SEE SO MOVED.
I SEE SECOND.
DON'T EVEN NEED TO ASK FOR THIS
AT THIS POINT.
I WILL ASK, IS THERE ANY
ADDITIONAL DISCUSSION?
I DON'T SEE ANY HANDS, AND I DO
NOT SEE ANY COMMENTS IN THE
CHAT.
IN THAT CASE, I WILL TURN THE
VOTE OVER TO CHRISTINA SO SHE
CAN CONDUCT THE VOTE.
CHRISTINA?
>> THANK YOU, DR. GRIEDER.
THE POLL SHOULD AUTOMATICALLY
APPEAR ON YOUR SCREEN WHEN IT IS
LAUNCHED.
PLEASE REMEMBER TO HIT SUBMIT
AFTER YOU'VE SELECTED YOUR VOTE.
THE VOTE WILL ONLY COUNT AFTER
YOU HIT SUBMIT.
AS A REMINDER, ONLY
COUNCILMEMBERS SHOULD
PARTICIPATE IN THE POLL.
THE POLL IS STARTING NOW.
>> WE'RE NOT GETTING ANYTHING.
AT LEAST NOT ME.
>> IS EVERYBODY --
>> WE'RE NOT GETTING --
>> YES, WE'RE ALL HAVING
PROBLEMS GETTING THE POLL.
>> THERE'S A SECOND WINDOW THAT
POPS UP, SO YOU MIGHT HAVE TO
JUST MAKE SURE YOU'RE SEEING ALL
THE WINDOWS.
>> I SAW IT.
>> OR IF YOU OPEN YOUR CHAT, IT
ALSO POPS UP IN YOUR CHAT
WINDOW.
>> IT'S IN THE CHAT.
>> THE POLL SHOULD APPEAR EITHER
ON YOUR SCREEN AS A POP-UP OR IT
WILL APPEAR IN THE CHAT.
>> IT'S IN THE CHAT BUT IT SAYS
THE BUTTON IS DISABLED, CONTACT
YOUR IT ADMIN FOR MORE
INFORMATION.
>> IT SAYS THIS BOT IS DISABLED.
THAT'S WHAT MINE SAYS.
>> I WOULD ASSUME IN THE CHAT,
THEY CAN'T VOTE.
THEY HAVE TO HAVE THE POP-UP
WINDOW.
IN MY SCREEN, THE POP-UP WINDOW
IS IN FRONT OF THE TEAMS
MEETING, AND FOR YOU AS WAS
DISCUSSED, IT MAY BE BEHIND.
>> AND AS A REMINDER, ONLY
COUNCILMEMBERS SHOULD
PARTICIPATE.
>> WE ALREADY HAVE 12 VOTES.
>> IT SAID IN MINE THAT
SOMETHING WENT WRONG IN THE
VOTE.
I DID HIT APPROVE AND SUBMITTED
BUT IT SAID SOMETHING WENT
WRONG.
THIS IS BARBARA TALKING.
I TRIED TO VOTE.
>> SO LET'S TRY SOMETHING.
LET'S ABANDON THIS WHOLE VOTE
AND START OVER.
BECAUSE WE ARE ACTUALLY SEEING
12 VOTES SO 12 OF YOU DID VOTE.
ALSO I NEED TO REMIND YOU DON'T
VOTE TWICE.
ONLY VOTE ONCE.
BUT SO CHRISTINA WILL START
OVER.
SHE WILL SAY HER SAME LITTLE
THING AGAIN ABOUT THE VOTE.
SO PLEASE LET'S START OVER.
>> THE POLL IS CLOSING.
>> THE OLD POLL IS CLOSING.
>> WE WILL OPEN UP A NEW POLL.
THIS POLL WILL HAVE A NUMBER
2 NEXT TO IT.
IT SHOULD APPEAR ON YOUR SCREEN
WHEN IT IS LAUNCHED.
PLEASE REMEMBER TO HIT SUBMIT IN
ORDER FOR YOUR VOTE TO COUNT.
>> CHRISTINA, THIS TIME I CAN'T
SEE IT.
NOT THAT I CAN VOTE BUT THIS
TIME I COULD NOT SEE IT, OR I
CAN'T SEE IT.
>> NOR COULD I, AND I VOTED THE
FIRST TIME.
>> ONE MOMENT.
WE ARE JUST ABOUT TO LAUNCH IT
AND IT SHOULD LAUNCH NOW.
>> ALL RIGHT.
SO NOW I CAN SEE IT, I HOPE
EVERYBODY ELSE CAN SEE IT AS
WELL.
>> YES.
>> THANK YOU FOR YOUR PATIENCE.
>> DID THOSE WHO --
>> I CAN ONLY SEE IT IN THE
CHAT.
>> AND DO YOU STILL HAVE THE
BLOCKING THAT IT SAYS YOUR
ORGANIZATION IS NOT ALLOWING
THIS BOT?
I SEE YOU'RE SHAKING YOUR HEAD.
>> IT SAYS THE BOT IS DISABLED.
>> I THINK THAT MIGHT BE YOUR
UNIVERSITY'S, ON YOUR END THAT
THEY'RE NOT ALLOWING THAT TO
OCCUR.
>> OKAY.
>> THIS IS BARBARA.
I'M GOING TO LOG IN IN A
DIFFERENT DEVICE.
I VOTE BUT IT SAID SOMETHING
WENT WRONG WITH THE VOTE SO I'M
GOING TO TRY A DIFFERENT DEVICE.
>> SO LET ME ASK, HOW MANY
PEOPLE HAD THE BLOCK FROM THEIR
INSTITUTION OR FROM SOMEWHERE
ELSE?
I SEE NINE RESPONSES AT THIS
POINT.
THEN BARBARA SAID SHE WOULD LOG
IN IN A DIFFERENT WAY.
I SAW ONE HAND UP.
BARBARA, MONICA.
YEP.
>> I DON'T KNOW IF WE WANT TO
DISCUSS THIS NOW BUT I JUST
OPENED TEAMS INSTEAD OF THE
BROWSER AND IT ASKED ME DO YOU
ALLOW WINDOWS TO POP UP AND I
SAID YES.
SO MAYBE THE NEXT TIME AROUND
I'LL BE ABLE TO SEE IT.
>> SO THE OTHER VERSION THAT WE
CAN DO, WE CAN JUST VOTE BY
RAISED HANDS FOR THIS CONCEPT
AND THEN MAYBE TRY AGAIN FOR THE
NEXT CONCEPT, WHEN PEOPLE
CORRECT IT.
WILL THAT WORK FOR EVERYBODY?
SO WE COULD JUST ASK ALL THOSE
IN FAVOR AND THEN YOU RAISE
YOUR -- ACTUALLY WE SHOULD GIVE
INSTRUCTIONS.
IF YOU COULD RAISE YOUR VIRTUAL
HANDS, THAT WOULD BE INCREDIBLY
HELPFUL.
SO WE HAVE AT THIS POINT DICK
AND -- OKAY, SO NOW THE HANDS
COME UP.
I LIKE IT.
SO WE HAVE AT THIS POINT RAISED
HANDS FOR THOSE IN FAVOR.
THEN I WILL ASK THROWS AGAINST T
AND THEN THOSE ABSTAINED.
ALL RIGHT.
I SEE 14 HANDS UP.
AND I COUNT THOSE -- DO I SEE 14
OR DO I SEE 13?
15 NOW?
CAN YOU ALL SEE HOW MANY HANDS?
I WANT TO RELY ON SOMEBODY WHO
COUNTS BETTER THAN ME.
>> THERE ARE 15 RAISED HANDS.
>> 15 RAISED HANDS, I COUNT
THOSE AS YES.
WOULD YOU BE ABLE TO TAKE YOUR
HANDS DOWN AT THIS POINT AND
THEN I ASK FOR THE NO'S.
ALL HANDS DOWN.
THIS SEEMS LIKE VERY INEFFICIENT
WAY TO DO IT, BUT -- ALL RIGHT.
ALL HANDS DOWN, GOOD.
SO NOW I ASK ALL THOSE WHO ARE
AGAINST THIS CONCEPT, PLEASE
VOTE.
NOT SEEING ANYBODY, I'M MOVING
ALONG.
ANY AB SENGSES?
-- ANY ABSTENTIONS?
NOT SEEING ANYBODY.
WE GO WITH THE 15 YESES.
THANK YOU VERY MUCH FOR THOSE
VOTES.
LET'S HOPE THE NEXT ONE, WE CAN
DO A LITTLE BIT MORE SMOOTHLY.
WITH THAT, BACK TO YOU, NICOLE.
>> OKAY, THANK YOU.
JUST TO CLARIFY, THE MOTION AS
STATED HAS PASSED.
SO OUR NEXT CONCEPT CLEARANCE
FOR TODAY IS A REISSUE FOR THE
OFFICE OF STRATEGIC
COORDINATION.
DRS. TRISH LABOSKY AND BECKY
MILLER, PROGRAM LEADERS IN OSC,
WILL PRESENT ON THE CONCEPT
ENTITLED HIGH RISK HIGH REWARD
OR HRHR RESEARCH PROGRAM.
THE PRESENTATION WILL BE
FOLLOWED BY COMMENTS FROM TWO
ASSIGNED COUNCILMEMBER
DISCUSSANTS, DR. JENNIFER MANLY
AND DR. MONICA GANDHI.
FOLLOWING THE VOTE, WE WILL MOVE
ON TO A PRESENTATION BY OSC
DIRECTOR DR. CAROLYN HUTTER TO
DISCUSS A NEW COUNCIL OF
COUNCILS WORKING GROUP ON HRHR.
OVER TO YOU, TRISH AND BECKY.
>> THANKS.
GOOD MORNING.
CAN EVERYBODY HEAR ME?
>> YES, WE CAN.
>> OH, GOOD.
ALL RIGHT.
SO GOOD MORNING, AND I'M HERE TO
TALK TO YOU BRIEFLY ABOUT THE
RENEWAL.
WE'VE HAD THIS PROGRAM GOING ON
FOR A WHILE, BUT THE REKNEEL OF
THESE FOUR HIGH RISK, HIGH
REWARD NOTICES OF FUNDING
OPPORTUNITIES.
SO ON THE NEXT SLIDE, THIS -- I
CAN'T ADVANCE THE SLIDES, AND I
ALSO CAN'T SEE THE BOTTOM LINE,
BUT THAT MIGHT BE MY SCREEN.
ANYWAY.
SO WE'RE HERE TODAY TO TALK
ABOUT THESE FOUR INITIATIVES
WITHIN THE NIH DIRECTOR'S HIGH
RISK HIGH REWARD RESEARCH
PROGRAM.
SO THE FOUR OF THEM ARE IN FRONT
OF YOU ON THE SCREEN.
THE PIONEER, THE NEW INNOVATOR,
WHICH IS AN ESI EFFORT, EARLY
STAGE INVESTIGATOR, THE
TRANSFORMATIVE RESEARCH AWARD
THAT USES AN R01, AND THE EARLY
INDEPENDENCE AWARD, WHICH IS
ALSO KNOWN AS SKIP THE POSTDOC.
SO WE'RE HERE TO GET CLEARANCE
FROM YOU ALL ON THE REISSUANCE
OF THESE FUNDING OPPORTUNITIES.
SO THE OBJECTIVE OF ALL FOUR OF
THESE PROGRAMS IS REALLY TO
ENABLE IMPORTANT INNOVATIVE BOLD
RESEARCH IDEAS, THREE OF THEM
ARE VERY HIGHLY FOCUSED ON THE
INDIVIDUAL, AND THEN THE THIRD
ONE, THE TRANSFORMATIVE RESEARCH
PROGRAM, IS MORE PROJECT OR
PROGRAM, EXPERIMENTALLY FOCUSED.
BUT REALLY WHAT WE WANT TO DO IS
TRY TO MOVE FORWARD THAT
SCIENTIFIC NEEDLE.
THESE HAVE TO BE BOLD, THESE
HAVE TO BE INNOVATIVE, THEY HAVE
TO TEST OR PRESENT OR HOPEFULLY
MAKE NEW SCIENTIFIC PARADIGMS.
SO FOR THE FUNDS AVAILABLE, WE
HAVE LISTED THERE ALMOST
$60 MILLION PER YEAR OVER THE
NEXT FIVE YEARS.
THE ANTICIPATION IS BETWEEN 50
TO 60 AWARDS PER YEAR.
AND WE BROKE THAT DOWN FOR
EXAMPLE FOR NEXT YEAR FOR FISCAL
YEAR '26, WE WOULD GUESSTIMATE
EIGHT PIONEER AWARDS,
APPROXIMATELY 26 NEW INNOVATOR
AWARDS, SEVEN TRANSFORMATIVE
RESEARCH AWARDS, AND 13 EARLY
INDEPENDENCE AWARDS.
EACH AWARD IS FIVE YEARS.
BUT THE PROGRAM IS NOT BEING
RENEWED.
IT'S JUST THESE FUNDING
OPPORTUNITIES.
SO OUR HOPE TODAY IS TO VOTE,
ALTHOUGH I SAW HOW CHALLENGING
VOTING IS, VOTE FOR APPROVAL OF
THE CONCEPT FOR THE FOUR NOTICES
OF FUNDING OPPORTUNITIES LISTED
ABOVE.
SO ON THE NEXT SLIDE, THIS IS
THE GRAPHIC WE USE FOR OUR FOUR
INITIATIVES.
PIONEER, NEW INNOVATOR,
TRANSFORMATIVE RESEARCH, AND
EARLY INDEPENDENCE AWARDS.
ALL OF THEM ARE DESIGNED TO
FOSTER THESE INCREDIBLE
SCIENTIFIC LEAPS.
WE WILL TAKE ANY SCIENTIFIC
FOCUS, SO ANYTHING WITHIN THE
MISSION OF NIH IS WELCOME.
THIS IS THE COMMON FUND'S
INVESTIGATOR INITIATED ARM.
FOR ALL FOUR OF THEM, WE DON'T
NEED ANY PRELIMINARY DATA, WE
DON'T REQUIRE ANY DETAILED
EXPERIMENTAL PLAN.
ALL OF THEM USE RATHER
NON-STANDARD APPLICATION FORMATS
AND, IMPORTANTLY, REVIEW
PROCESSES.
FOR EXAMPLE, THE PIONEER INN
VOPIONEE INVOLVE
AND INTERVIEW WITH THE
APPLICANTS AND AN ESSAY RATHER
THAN A REVE RESEARCH STRATEGY.
WE REALLY WANT THEM TO TELL A
STORY OF HOW THEIR PROJECT GG TO
MOVE THE SCIENTIFIC NEEDLE.
I MENTIONED BEFORE THE HRHR --
[INTERRUPTION]
THAT WAS WEIRD, I GOT A WEIRD
ECHO.
THE HRHR PROGRAM IS NOT SUBJECT
TO THE TENURE TIME LIMIT, BUT
EACH INDIVIDUAL AWARD IS SUBJECT
TO A FIVE-YEAR LIMIT FOR THE
AWARD.
ALL FOUR OF THE DWOAL GOALS, ALR
OF THE PROJECTS IS TO FOSTER
THESE BOLD SCIENTIFIC LEAPS
FORWARD, AND THE IDEA IS
SUPPORTING EXCEPTIONAL
CREATIVITY IN THE SCIENCE.
WE WANT REALLY INNOVATIVE
RESEARCH.
SO WE WANT THE PIE IN THE SKY
THINGS.
WHAT WE LOVE TO HEAR IS WHEN THE
REVIEWERS SAY, I WISH I'D
THOUGHT OF THAT.
OR, THIS SOUNDS LIKE SCIENTIFIC
FICTION, IF THIS COULD HAPPEN,
THIS WOULD BE AMAZING.
SO ALL OF THEM HAVE TO RESULT IN
BOLD AND HIGHLY INNOVATIVE
RESEARCH.
BOTH THE NEW INNOVATOR AND EARLY
INDEPENDENCE AWARDS WILL SUPPORT
EARLY STAGE INVESTIGATORS, THE
NIH ESI, EARLY INVESTIGATORS,
WHICH IS AN IMPORTANT PART OF
THE PROGRAM AND AN IMPORTANT
EMPHASIS FOR NIH.
ON THE NEXT SLIDE, I'LL GO
QUICKLY THROUGH THE FOUR
INITIATIVES HERE.
THE PIE NER.
PIONEER.
USUALLY WE SEE MORE SENIOR
INVESTIGATORS THAT COMPETE
BETTER FOR THIS.
IMPORTANTLY, THE RESEARCH
DIRECTION MUST BE NEW, HENCE THE
PIONEER NAME, RIGHT, HAS TO TAKE
UP A MAJOR PORTION OF THEIR
RESEARCH EFFORTS, MORE THAN
HALF, FOR THE FIRST THREE YEARS,
THEN IT TAPERS DOWN BECAUSE
THESE ARE NOT RENEWABLE.
THEY'RE HIGHLY FLEXIBLE.
SO IF SOMETHING NEEDS TO CHANGE
WITHIN THE FIVE YEARS, IF
SOMETHING DOESN'T WORK, THE
INVESTIGATOR IS TOLD TO WORK
WITH THEIR PROGRAM OFFICER AND
MAKE CHANGES.
SO AGAIN WE MAKE APPROXIMATELY
SEVEN OF THOSE A YEAR.
THE NEW INNOVATOR AWARD, THIS IS
THE FIRST ONE THAT SUPPORTS
EARLY STAGE INVESTIGATORS, AND
AGAIN, MUST BE HIGHLY
INNOVATIVE.
IT'S IN THE TITLE, THAT'S WHAT I
TELL APPLICANTS ALL THE TIME.
WE WANT THE INNOVATION TO BE OFF
THE SCALE.
AT THE SAME TIME REVIEWERS DO
FOCUS AT LEAST A LITTLE BIT ON
FEASIBILITY, SO THEY'RE NOT
CRAZY INNOVATION, THEY'RE
DOABLE.
SO IT'S SIMILAR TO THE PIONEER
IN SPIRIT BUT AGAIN IT'S ONLY
EARLY STAGE INVESTIGATORS.
FOR THOSE OF WHO YOU DON'T
REMEMBER, THAT'S AN INDIVIDUAL
THAT'S WITHIN 10 YEARS OF THEIR
TERMINAL DOCTORATE, THEIR PH.D.
OR THEIR CLINICAL RESIDENCY IF
THEY'RE AN M.D. AND THEY MUST
NOT HAVE RECEIVED A LARGE
INDEPENDENT NIH GRANT YET.
SO THEY NEED TO FOCUS 25% OF
THEIR RESEARCH EFFORT, AND
AGAIN, THEY HAVE THE REVIEW AND
THE ESSAY HAS TO FOCUS ON THE
IDEA, INNOVATION, POTENTIAL
IMPACT, THE HISTORY, THE TRACK
RECORD OF INNOVATION FOR THE PI,
AND THEN, OF COURSE, WHY THIS
SHOULD BE A NEW INNOVATOR AWARD
AND NOT AN R01.
THE NEXT AWARD, ON THE NEXT
SLIDE, THE TRANS FORMATIVE
RESEARCH AWARD, WE ACTUALLY DO
USE AN R01 MECHANISM, A MORE
TRADITIONAL MECHANISM, BUT WE
USE IT VERY DIFFERENTLY.
THIS AWARD, DIFFERENT FROM ALL
THE OTHERS, COULD SUPPORT A
PROJECT THAT MIGHT BE A TEAM
APPROACH IT COULD ALSO BE A
SINGLE PI BUT YOU COULD HAVE A
TEAM HERE.
THE BUDGET IS FLEXIBLE.
IT'S NOT FIXED.
IT HAS TO BE VERY WELL JUSTIFIED
BUT IT'S NOT FIXED AT A CERTAIN
AMOUNT.
THERE'S A LITTLE BIT MORE
EMPHASIS HERE ON THE PROJECT
VERSUS ON JUST THE PI.
THE PI OF COURSE HAS TO BE
STELLAR BUT REALLY THE REVIEWERS
ARE TOLD TO LOOK AT THE PROJECT.
AGAIN, YOU DO NOT NEED
PRELIMINARY DATA, YOU DON'T NEED
A DETAILED EXPERIMENTAL PLAN.
SO THE LAST ONE, THE FOURTH ONE,
IS THE NIH DIRECTOR'S EARLY
INDEPENDENCE AWARD, RIGHT?
SO THESE ARE INDIVIDUALS
SKIPPING THEIR INDIVIDUAL
POSTDOC AND IT'S FOR A REALLY
SPECIAL GROUP OF STUDENTS THAT
ARE GRADUATING AND THE TIME
WINDOW IS PRETTY TIGHT, I WON'T
GO INTO IT HERE.
BUT ABOUT A YEAR WITHIN THE TIME
OF THE APPLICATION, THEY HAVE TO
REALLY DEMONSTRATE AN INCREDIBLE
TRACK RECORD OF WHAT THEY'VE
DONE IN THE PAST.
THE OTHER THING THAT'S IMPORTANT
IS THE INSTITUTION SUPPORTING
THE APPLICATION, WHO'S THE REAL
APPLICANT, RIGHT, MUST GIVE
DEMONSTRATION OF REALLY
SUBSTANTIAL SUPPORT, COMMITMENT,
MONETARY COMMITMENT, SPACE, ET
CETERA, TO THAT INDIVIDUAL.
IF THEY RECEIVE AN AWARD, THE PI
WILL COMMIT 80% EFFORT AND THEY
MUST HAVE THAT AVAILABLE
RESEARCH EFFORT TIME THAT THEY
CAN GIVE.
SO JUST A LITTLE TASTE, I REALLY
CAN'T GIVE YOU ALL THE IMPACT
THAT THESE AWARDS HAVE MADE OVER
THE MANY YEARS.
YOU CAN GO TO OUR WEBSITE THIS,
IS JUST A SNAPSHOT OF SOME OF
THE RECENT HIGHLIGHTS WE'VE PUT
OUT THERE THAT HAVE BEEN REALLY
IMPORTANT SO WE HAVE AREAS OF
RESEARCH IN ALZHEIMER'S DISEASE,
KIDNEY DISEASE, MICROBIOME, GUT
INFLAMMATION, AND THEN THE LAST
ONE THERE IS DEVELOPMENT OF
LANGUAGE.
WE CHOSE THESE BECAUSE THEY'RE
RECENT, BUT ALSO TO GIVE YOU AN
IDEA OF HOW BROAD THE SCIENTIFIC
AREAS ARE WITH THE HRHR PROGRAM.
WE REALLY AIM TO HIT THE WHOLE
SCIENTIFIC ENTERPRISE OF NIH,
AND THAT'S HIGHLIGHTED ON THE
NEXT SLIDE WHICH IS THE WORKING
GROUP THAT I WORK WITH, WORK
VERY CLOSELY WITH, SOME HAVE
CHANGED VERY RECENTLY BUT YOU
CAN SEE IF YOU WANTED TO THAT
ALL 27 INSTITUTES AND CENTERS
ARE REPRESENTED HERE AND THESE
INDIVIDUALS PITCH IN, THEY
REALLY ARE A WONDERFUL GROUP,
BUT THIS IS PART OF WHY WE CAN
LOOK AT THE ENTIRE RESEARCH
ENTERPRISE.
SO ON THE NEXT SLIDE, I BELIEVE
IT'S -- YEAH, I TOSS THIS BACK
TO YOU, FRANZISKA, OR QUESTIONS?
I DON'T REMEMBER.
>> THANK YOU VERY MUCH.
SO ACTUALLY WE'LL NOW GO TO OUR
ASSIGNED DISCUSSANTS.
HOPEFULLY WE HAVE THE AUDIO
ISSUES WORKED OUT FOR DR. MANLY.
DR. MANLY, DO YOU --
>> I HOPE SO TOO.
>> YES, GREAT, WE CAN HEAR YOU.
>> WOO!
YOU CAN HEAR ME.
I'LL INTRODUCE MYSELF THEN
QUICKLY.
I'M A PROFESSOR IN THE NEUROLOGY
DEPARTMENT AT COLUMBIA
UNIVERSITY, AND I WAS PREVIOUSLY
ON THE NIA, THE COUNCIL ON
AGING, AND I'M VERY HAPPY TO BE
DISCUSSING THE HIGH RISK, HIGH
REWARD PROGRAM TODAY, THE
ADVANTAGES AND SUCCESSES ARE
MANY.
THE EXISTENCE OF A PROGRAM THAT
FOCUSES ON ENCOURAGE SOMETHING
CREATIVITY AND INNOVATION IN NIH
RESEARCH --
>> DR. MANLY, UNFORTUNATELY WE
HAVE LOST YOUR AUDIO.
JUST GIVE IT A MOMENT TO SEE IF
WE CAN REGAIN --
>> CAN YOU HEAR ME?
>> WE CAN HEAR YOU NOW.
IT SEEMS TO BE CUTTING IN AND
OUT.
I WOULD SUGGEST IF THAT HAPPENS
AGAIN, MAYBE TRY TURNING OFF
YOUR CAMERA TO SAVE BANDWIDTH,
BUT PLEASE GO AHEAD.
>> OKAY.
AS I WAS SAYING, THE SUPPORT FOR
EARLY STAGE INVESTIGATORS FOR
TWO OUT OF FOUR OF THESE AWARDS
AND THE BROAD IMPACT ACROSS THE
NIH ARE ALL ADVANTAGES.
I HAD SOME QUESTIONS, THOUGH.
SPECIFICALLY THE QUESTIONS ARE
WHAT ARE THE SPECIFIC METRICS OF
SUCCESS FOR THE HIGH RISK/HIGH
REWARD PROGRAM?
IN THE MATERIALS GIVEN, WE WERE
GIVEN A SNAPSHOT, YOU JUST
TALKED ABOUT IT, I FOLLOWED THE
LINK.
A LOT OF DIFFERENT GRANTS ARE
REPRESENTED AFTER YOU FOLLOW
THAT LINK, SO IT WAS HARD TO
IDENTIFY EXACTLY WHICH OF THOSE
NEWS STORIES --
>> SORRY, DR. MANLY, WE HAVE
LOST YOU AGAIN.
I WOULD SUGGEST AT THIS STAGE
TRYING TO TURN OFF VIDEO TO SAVE
BANDWIDTH AND THEN HOPEFULLY WE
CAN GET YOUR AUDIO BACK?
>> YEP.
>> WE CAN HEAR YOU NOW.
YES.
>> SO WHAT ARE SOME OF THE --
WHAT'S SOME OF THE EVIDENCE THAT
THE FOLKS WHO ARE AWARDED, HIGH
RISK/HIGH REWARD AWARDS, ARE
INDEED BOLD AND HIGHLY
INNOVATIVE RESEARCH.
WOULD SOME OF THE EVIDENCE BE
HIGH IMPACT PUBLICATIONS, NOVEL
DISCOVERIES, LIFE-CHANGING
TREATMENTS.
WHAT IS SOME OF THE EVIDENCE
THAT THESE HIGH RISK/HIGH REWARD
PROGRAMS ENGAGE SCIENTISTS
ACROSS ALL OF THE NIH INSTITUTES
AND ALL OF THE DISCIPLINES THAT
ARE REPRESENTED IN NIH?
ALL OF THE SIGNS WE HAVE NOW
POINT TO THE FUTURE BUDGET OF
NIH TO BE DRASTICALLY REDUCED.
HOW DO WE VIEW THE ROLE OF HIGH
RISK/HIGH REWARD PROGRAMS IN THE
CONTEXT OF DRASTICALLY REDUCED
RESOURCES.
FOR EXAMPLE, SHOULD THE HIGH
RISK/HIGH REWARD PROGRAM BE EVEN
MORE FOCUSED ON EARLY CAREER
RESEARCHERS GIVEN THE FUNDING
ENVIRONMENT THAT WE'RE ABOUT TO
ENTER.
AND THEN I ASK WHAT ARE THE
SPECIFIC OUTCOMES OF THE EARLY
INDEPENDENCE AWARD?
THIS IS THE ONE THAT ALLOWS FOR
POSTDOC TO BE SKIPPED.
WE WANT THESE SCIENTISTS TO BE
SUCCESSFUL, BUT WHAT IS THE
EVIDENCE THAT THEY ARE
SUCCESSFUL IN OBTAINING
R01 AWARDS AND PROMOTION TO
ASSOCIATE OR PROMOTION TO
TENURE?
AND THOSE ARE MY COMMENTS.
SORRY ABOUT THE AUDIO ISSUES.
>> OKAY.
I CAN -- THERE'S A LOT OF
QUESTIONS THERE BUT I CAN TRY TO
ANSWER SOME OF THESE.
THE METRICS OF SUCCESS, SOME OF
THEM ARE ONES THAT YOU CITED
THAT YOU MIGHT IMAGINE, THINGS
LIKE FOLLOW-ON FUNDING
ESPECIALLY FOR THE ESI PROGRAM,
THE NEW INNOVATORS AND THE EARLY
STAGE -- EARLY INDEPENDENCE
AWARD, FOLLOW-ON FUND SOMETHING
A HUGE METRIC OF SUCCESS.
OFTEN TENURE COMES TO THESE
FOLKS A LITTLE FURTHER OUT, SO
I'M NOT SURE THAT WE HAVE THOSE
DATA.
WE HAVE IT FOR DP2s FOR THE
NEW INNOVATORS BUT NOT EARLY
INDEPENDENCE AWARDEES.
ALTHOUGH IN A MINUTE, BECKY, I'M
GOING TO HAND IT OVER TO YOU TO
TALK ABOUT THAT.
WARNING.
FOR PIONEERS AND TRANSFORMATIVE
RESEARCH AWARDS, OBVIOUSLY ONE
OF THE METRICS OF SUCCESS WOULD
BE IMPORTANT PAPERS.
AND IMPACT IN THE FIELD THAT
THOSE PAPERS ARE USED.
WE OFTEN USE RELATIVE CITATION
RATIO TO FIGURE OUT THAT PAPERS
AREN'T JUST PUBLISHED AND
IGNORED, THAT THEY'RE ACTUALLY
CITED AND BUILT ON, SO AGAIN,
THIS TAKES TIME.
YOU CAN'T MEASURE THAT TWO OR
THREE YEARS AFTER THE END OF THE
AWARD.
IT TAKES A LITTLE WHILE, BUT
THAT'S ANOTHER WAY THAT WE LOOK
AT THESE.
IN FACT, WE'RE RIGHT IN THE
MIDDLE NOW OF DOING AN INTERNAL
EVALUATION FOR THE TOP 10
FINDINGS FROM THE HRHR PROGRAM.
THAT'S ONE OF THE THINGS THAT I
REALLY WANT TO BE ABLE TO
ARTICULATE VERY CLEARLY.
THE EVIDENCE FOR IMPACT ACROSS
ALL THE INSTITUTES AND CENTERS,
THE WAY MOST OF THESE AWARDS
WORK, EVERYTHING OTHER THAN THE
EARLY INDEPENDENCE AWARDS,
ALTHOUGH IT'S OFFICE OF DIRECTOR
FUNDS, THEY'RE ADMINISTERED OUT
THERE IN ONE OF THE OTHER 26
INSTITUTES OR CENTERS SO THEY'RE
MOVED OUT TO NCI OR NHLBI OR
WHEREVER THAT'S REALLY AN
IMPORTANT ASPECT OF THE PROGRAM
AND THAT'S HOW WE CAN SORT OF
MEASURE THAT WE ARE HITTING ALL
OF THE INSTITUTES AND CENTERS AT
NIH AND THAT ALL OF THE
INSTITUTES AND CENTERS AT NIH
ARE VERY EAGER TO TAKE THESE ON,
AND WE PLACE THEM WHERE THEY'RE
MOST SCIENTIFICALLY RELEVANT.
I DON'T HAVE THE DATA AT MY
FINGERTIPS BUT WE WOULD HAVE TO
PULL THAT UP FOR YOU BUT I
ASSURE YOU THAT SOME OF THE
SMALLER INSTITUTES AND CENTERS
ARE WELL REPRESENTED IN OUR
PORTFOLIO.
I CAN'T REALLY COMMENT ON THE
ROLE OF HRHR RESEARCH IN THE NIH
BUDGET.
I THINK THAT WILL BE A QUESTION
YOU CAN ASK SOME OF THE OTHER
NIH LEADERS COMING ON LATER
TODAY, I DON'T THINK THAT'S
SOMETHING I CAN COMMENT ON.
BECKY, DO YOU WANT TO TALK JUST
A LITTLE BIT ABOUT THE SUCCESS
OF THE EARLY INVESTIGATOR AWARD
RECIPIENTS?
>> SO FOR ALL FOUR INITIATIVES
IN OUR PROGRAM, WE'VE HAD A
THIRD PARTY EVALUATOR LOOK AT
THEM TO ACTUALLY CHART TO SEE
HOW WELL WE ARE DOING IN OUR
GOAL OF SUCCESSFULLY SUPPORTING
HIGH RISK RESEARCH.
FOR ALL THOSE, THEY ACTUALLY
DID -- THEY COMPARED OUR COHORTS
WITH A MATCHED R01 POOL TO LOOK
AT OUTPUTS AND VIEW WHETHER OR
NOT WE ARE, IN FACT, SEEING MORE
INNOVATIVE SCIENCE OUT OF OUR
GROUP.
A LOT OF DETAILS TO THAT BUT IN
GENERAL, FOR ALL FOUR
INITIATIVES, THOSE RESULTS --
THE EVALUATOR DID FIND WE WERE
SUCCESSFULLY ABLE TO SUPPORT
HIGH RISK SCIENCE SO A LOT OF
THOSE EVALUATIONS THAT ARE ON
OUR WEBSITE, YOU'RE WELCOME TO
GO LOOK THROUGH THEM, BUT IN
GENERAL, THEY HAVE FOUND THAT WE
ARE ABLE TO SUPPORT AND ARE
FINDING THOSE HIGH RISK
PROJECTS.
FOR THE EARLY INDEPENDENCE AWARD
WE ALSO HAD A THIRD PARTY
INVESTIGATE CONDUCTED ON IT.
AS YOU CAN IMAGINE IT WAS REALLY
HARD TO FIND A REALLY GOOD
COMPARISON GROUP FOR THESE BATCH
OF VERY AMBITIOUS AND MATURE
SCIENTISTS JUST COMING RIGHT OUT
OF GRAD SCHOOL.
SO THEY USED ESI R01 AND THEY
WERE ABLE TO CONDUCT SURVEYS,
THEY LOOKED AT THINGS LIKE
CAREER ADVANCEMENT SO WHEN DID
YOU GET TENURE, WHAT WERE YOUR
RESEARCH OUTPUTS, FOLLOW-ON
FUNDING, ALL OF THAT
INFORMATION, AND THEY FOUND THE
EARLY INDEPENDENCE AWARDEES WERE
ABLE TO -- THEY MATCHED THE ESI
R01 COMPARISON POOL IN TERMS OF
LENGTH OF TIME FOR TENURE, THEIR
RESEARCH OUTPUTS AND ALL OF
THAT, AND THEY WERE ABLE TO DO
ALL THIS AFTER SKIPPING
ADDITIONAL TRAINING, SO WE FELT
THAT WAS A GREAT SUCCESS FOR THE
EARLY INDEPENDENCE AWARD.
>> I WANT TO MENTION, I DIDN'T
SAY THIS, THAT THE EARLY
INDEPENDENCE AWARDS ARE MANAGED
DIRECTLY BY BECKY.
SHE IS THE PROGRAM OFFICER FOR
ALL OF THOSE AWARDS.
SHE GOES ON SITE VISITS, MEETS
WITH PIs, MEETS WITH THE
INSTITUTIONS TO MAKE SURE THAT
THE GOALS OF THE PROGRAM ARE
SUPPORTED AND THAT THOSE PIs
HAVE THE SUPPORT THAT WAS
PROMISED TO THEM IN THE
APPLICATION BECAUSE THAT'S A
HUGE PART OF THIS, THE
INSTITUTIONAL SUPPORT MATTERS A
LOT.
>> I AGREE.
THANK YOU FOR YOUR ANSWERS.
>> THANK YOU ALL.
NOW I'LL TURN IT OVER TO
DR. GANDHI TO ADD ANY COMMENTS.
>> SO I HIGHLY SUPPORT ALL FOUR
OF THESE, THE RECENT EVENTS HAVE
CREATED A CHILLING EFFECT FOR
RESEARCHERS AT T -- THE EXTRAMUL
RESEARCHERS AT THE NIH, BOTH
EARLY STAGE AND LATER STAGE
INVESTIGATORS, AND WHAT WOULD BE
GREAT TO HELP IN TERMS OF
GETTING ON TRACK IS TO FOCUS ON
ACTUALLY NOT JUST THE EARLY
STAGE BUT TO THINK ABOUT THE
TRANSFORMATIVE RESEARCH AWARDS
AND PIONEER AWARDS IN TERMS OF
BEING AT ANY CAREER STAGE.
I THINK THAT IF WE TAKE THOSE
TWO SEPARATELY, ONE IS
ESSENTIALLY PIONEER AWARD IS
PERSON BASED AND THE OTHER,
TRANSFORMATIVE RESEARCH AWARD,
IS PROJECT BASED.
WHAT I THINK IS REALLY NEEDED
RIGHT NOW IS AN IDEA THAT YOU
CAN HELP WITH GIVEN TERMINATED
GRANTS AND OTHER CONCERNS THAT
HAVE BEEN REALLY DIFFICULT FOR
CURRENT EXTRAMURAL RESEARCHERS
FIGURE OUT IF THERE COULD BE AN
EXPANSION OF THIS PROGRAM TO GET
PEOPLE SORT OF MORE ON A PROJECT
BASED WAY FOR THE TRANSFORMATIVE
AND PIONEER FOR THE PERSON BASED
HELP GET BACK ON TRACK WITH
FUNDING.
SO I WOULD CERTAINLY SUPPORT
THIS BUT BEYOND SUPPORT THIS
HOPE THAT THERE IS EVEN
EXPANSION OF THOSE PARTICULAR
ONES WITH THE K AWARDS WITH THE
EARLY STAGE INVESTIGATOR, DP2s
HAVE BEEN INCREDIBLE TO -- IT
DOES TAKE AWAY YOUR EARLY CAREER
STATUS BUT YOU GET $200,000 A
YEAR WHICH IS KIND OF IN BETWEEN
A -- IT'S ESSENTIALLY NOT AS
MUCH AS A $500,000 A YEAR FOR AN
R01 BUT WE HAVE SEVERAL PEOPLE
THAT ARE DP2s IN THEIR -- BUT
IF WE COULD FOCUS ON ANY CAREER
STAGE AWARDS AND MAYBE ENHANCE
THOSE TO KIND OF HELP PEOPLE
WITH WHAT'S HAPPENING RIGHT NOW.
THANK YOU.
>> THANK YOU.
THAT'S A VERY IMPORTANT
OBSERVATION.
AFTER THE VOTE, OUR OFFICE
DIRECTOR IS GOING TO TALK ABOUT
SOME -- WELL, YOU'LL SEE SOME
MAYBE POTENTIAL IDEAS FOR
EXPANDING THE HRHR EFFORTS IN
OUR GROUP.
>> THANK YOU.
>> GREAT, THANK YOU.
WE'LL TURN IT OVER TO OTHER
COUNCILMEMBERS FOR QUESTIONS OR
COMMENTS, AND I SEE SOME HANDS
ALREADY BEING RAISED.
FRANZISKA?
>> I SEE RHONDA, YOUR HAND IS
UP.
WHY DON'T I GO TO YOU FIRST FOR
YOUR QUESTION OR COMMENT.
>> THANK YOU SO MUCH.
THANK YOU FOR THIS PRESENTATION.
CERTAINLY THIS IS ONE OF THE
HALL MARKS OF NIH INNOVATION AND
REALLY BEING ABLE TO PROMOTE
CREATIVITY IN THIS WAY.
I JUST HAVE A COUPLE QUESTIONS.
PART OF IT IS WHAT DR. MANLY
BROUGHT UP IN TERMS OF METRICS
TO SHOW SUCCESS.
GIVEN THE ENVIRONMENT AND
PARTICULARLY WITH CUTS TO NIH,
ARE THERE ANY CONSIDERATIONS AS
IT RELATES TO THE AREAS IN WHICH
INDIVIDUALS PLAN TO RESEARCH IN,
AND I BRING THAT UP FROM THE
STANDPOINT OF VIEW, CERTAINLY
SCIENTIFICALLY RELEVANT WAS A
TERM USED BUT ALSO HIGH RISK
SCIENCE TOO.
I'D LIKE TO BRING ANOTHER
CONSIDERATION HERE, AND THAT IS
THE AREAS WITHIN OUR HEALTHCARE
DELIVERY SYSTEM WHERE THERE'S
NEED FOR NEW INNOVATIVE WAYS OF
APPROACHING.
LET ME GIVE A SIMPLE EXAMPLE OF
ONE FROM INDIA, WHERE THE WISH
FOUNDATION ACTUALLY FUNDED, PUT
OUT RFIs, I GUESS YOU COULD
CALL THEM, OR GRANTS FOR
INNOVATORS TO COME UP WITH A WAY
TO DO MAMMOGRAMS SUCCESSFULLY
BUT AT A LOWER COST SINCE IT IS
A SCREENING MECHANISM THAT CAN
BE MORE APPLICABLE IF IT'S
SOMETHING THAT'S MORE
AFFORDABLE.
IS SO SO I'M JUST WONDERING WHER
NOT THERE ARE OTHER
CONSIDERATIONS OR THEMES THAT
WILL BE INTRODUCED IN THE
DECISIONS OF WHICH THINGS GO
FORWARD, RECOGNIZING THAT WE'RE
IN A SITUATION WHERE BUDGETS ARE
VERY IMPORTANT, BEING ABLE TO BE
COST-EFFECTIVE AS WELL AS
SCIENTIFICALLY EFFECTIVE.
THANK YOU.
>> THANK YOU, THAT'S A GOOD
QUESTION.
AS I MENTIONED, WE INVITE ALL
RESEARCH FROM ACROSS THE NIH
MISSION SPACE, AND OBVIOUSLY THE
AREAS YOU'RE CITING ARE WITHIN
THE NIH MISSION AND THEY WOULD
BE ENCOURAGED TO APPLY.
I CAN'T TELL YOU HOW MANY EMAILS
I GET ASKING WHETHER THIS AREA
OR THAT AREA IS ELIGIBLE AND THE
ANSWER IS ALMOST ALWAYS YES,
IT'S ELIGIBLE.
SO THEY'RE ALWAYS ELIGIBLE TO
APPLY.
THE CRITICAL THING FOR US IS
THEY MUST FAIR WELL IN PEER
REVIEW.
SO IF IT'S AN OUT THERE IDEA ON
AN AREA WE WOULD LIKE TO SUPPORT
BUT THEY DON'T DO WELL IN PEER
REVIEW, WE CAN'T DO ANYTHING
ABOUT THAT REALLY.
SO WE KEEP IT OPEN.
WE DON'T SPECIFY YOU WOULD LIKE
TO HAVE MAYBE HEALTHCARE
DELIVERY AREAS OF RESEARCH
EMPHASIZED, WE HAVE NOT DONE
THAT.
THERE ARE OTHER EFFORTS ACROSS
THE ICs IN MORE SPECIFIC AREAS
OF RESEARCH BY THE WAY THAT DO
THAT.
BUT I'M JUST TALKING ABOUT OUR
PROGRAM.
THE OTHER THING THAT'S IMPORTANT
TO NOTE IS IF THE APPLICATIONS
RECEIVE A SCORE, THEY GO THROUGH
A PROCESS CALLED PROGRAMMATIC
PRIORITY REVIEW AND THAT IS
WRITTEN OUT IN THE FUNDING
OPPORTUNITY.
ONE OF THE THINGS WE CAN
EMPHASIZE IS IF THE AREA OF
SCIENCE IS OUTSIDE WHAT WE'VE
FUNDED A LOT IN THE PAST, FOR
EXAMPLE, AND IF THERE IS
SOMETHING THAT RECEIVE AS SCORE
THAT MAYBE IS ON THE BORDER
BETWEEN LINES OF FUNDING OR NOT,
BUT IT'S SOMETHING WE'VE NEVER
SEEN BEFORE, AND WE NOTE AND THE
REVIEWERS NOTE THAT THIS GG TO
MAKE A HUGE IMPACT, WE CAN
SUPPORT THINGS LIKE THAT.
SO I THINK THAT'S AN IMPORTANT
ASPECT OF HOW WE TRY TO SPREAD
THE FUNDING TO REALLY COVER
EVERY AREA OF SCIENCE THAT IS
PEER-REVIEWED FAVORABLY.
BUT THAT PEER REVIEW IS
IMPORTANT, AND I'LL TELL YOU
THAT THAT'S YOU ALL OR YOUR
PEERS THAT ARE DOING THAT
REVIEW.
SO WE ARE BEHOLDEN TO THAT, AT
LEAST A LITTLE BIT.
DOES THAT ANSWER YOUR QUESTION?
>> YES, IT HAS.
THANK YOU SO MUCH.
I APPRECIATE YOUR RESPONSE.
>> GREAT.
THANK YOU VERY MUCH.
I SEE THREE MORE QUESTIONS OR
THREE MORE HANDS, AND,
THEREFORE, LET'S GO WITH THEM.
SO RAFAEL, YOU'RE FIRST,
FOLLOWED BY RUSS AND THEN JEN.
>> THANK YOU.
I AM FULLY SUPPORTIVE OF THIS, I
THINK THERE SHOULD BE EVEN MORE
FUNDING OF THESE KINDS OF
INITIATIVES COMPARED TO SOME OF
THE OTHER RESEARCH THAT IS
FUNDED BY THE NIH.
PLY QUESTMY QUESTION IS IF EVERY
INSTITUTION -- RESEARCH
INSTITUTION IS GOING TO BE -- IS
THIS GOING TO BE AVAILABLE TO
ALL RESEARCH INSTITUTIONS?
AND IF NOT, WHAT ARE THE
CRITERIA TO EXCLUDE THEM AND HOW
WILL THEY KNOW IN ADVANCE SO
THEY CANNOT APPLY OR SPEND TIME
APPLYING?
>> I'M SORRY I DIDN'T MAKE THAT
CLEAR EARLIER.
THIS IS OPEN TO ALL ELIGIBLE
INSTITUTIONS.
SO ANY INSTITUTION THAT CAN
APPLY FOR R01s, THAT THEY
WOULD BE ELIGIBLE.
THERE'S NO LIMITATIONS ON THAT.
>> GREAT, THANK YOU, PAT.
RUSS.
>> GREAT.
THANK YOU.
I'M ALSO VERY SUPPORTIVE OF
THESE PROGRAMS.
BOTH IN THE LAST CONCEPT
CLEARANCE AND THIS ONE, THE
QUESTION HAS COME UP AS TO HOW
WE MEASURE SUCCESS AND WHAT
THOSE KEY PERFORMANCE INDICATORS
ARE.
WE HAVE A NATURAL EXPERIMENT
WHICH IS THAT YOU HAVE MANY
INDIVIDUALS WHO APPLY FOR THESE
AWARDS AND ARE NOT GRANTED THEM.
AND IN PARTICULAR, STUDY SECTION
IS RANKING THESE APPLICATIONS
AND THERE'S A CUTOFF LINE,
THERE'S SOME FUNDING LINE, AND
THE FOLKS WHO WERE JUST BELOW
AND JUST ABOVE THAT FUNDING LINE
SORT OF MAKE A NATURAL
EXPERIMENT TO SAY WHAT WOULD
HAPPEN IF YOU DIDN'T HAVE
SUPPORT OF THIS PROGRAM.
IS THERE ANY CONSIDERATION
INSTEAD OF JUST LISTING THE
ACCOMPLISHMENTS OF THE AWARDEES,
PARTICULARLY FOR THOSE EARLY
CAREER AWARDS, OF ACTUALLY
ASKING HOW DID THEIR CAREER
TRAJECTORIES COMPARE WITH THOSE
WHO DID NOT -- WHO WERE NOT
AWARDED THESE PARTICULAR
MECHANISMS?
>> WELL, AS BECKY OUTLINED, WHAT
WE'VE DONE IN THE PAST IS
COMPARE OUR AWARD RECIPIENTS TO
R01 AWARD RECIPIENTS.
NOW, I'VE NEVER GONE THROUGH AND
LOOKED AT WHETHER OR NOT THE
PEOPLE THAT ARE ON THAT LINE
RECEIVED AN R01 IN THE SAME
COMPETITION YEAR, IF THEY EXIST,
I THINK THAT WOULD BE VERY FEW.
I DON'T THINK IT'S FAIR TO
COMPARE AWARDEES AND
NON-AWARDEES IF THOSE
NON-AWARDEES DIDN'T GET ANY
FUNDING, RIGHT?
I THINK WE KNOW WHAT MIGHT
HAPPEN TO THEM.
WE CAN DO THAT, I SUPPOSE, IT
WOULDN'T BE HARD, BUT WE HAVE
NOT.
I DON'T KNOW, BECKY, DO YOU WANT
TO ADD IN ON THAT?
>> WE DID LOOK AT THOSE WHO WERE
SCORED BUT WERE NOT ULTIMATELY
FUNDED FOR THE PIONEER
EVALUATION.
BUT WE HAVEN'T -- THERE WERE
PROBLEM WITH THAT COMPARISON, SO
IN THE FUTURE, WHEN WE LOOKED TO
OTHER INITIATIVES, WE OPTED NOT
TO USE THAT POOL AS THE
COMPARATOR, JUST BECAUSE IT
WASN'T DEEMED FAIR COMPARISON.
>> AS OTHERS HAVE MENTIONED, IF
WE'RE GOING INTO AN AUSTERE
PERIOD OF FUNDING, DEMONSTRATING
VALUE FOR THE EXISTING FUNDING
MECHANISMS IS GOING TO BECOME
EVEN MORE IMPORTANT, AND THERE'S
A LITTLE BIT OF AN INTRINSIC
BIAS HERE THAT YOUR MOST
OUTSTANDING CANDIDATES ARE
LIKELY TO WIN THESE AWARDS, AND
THEY'RE MOST LIKELY TO SUCCEED
IN ANY CASE AND SO TO SOME
EXTENT, I THINK -- TO THE EXTENT
THAT WE CAN DEMONSTRATE THE TRUE
VALUE OF THESE MECHANISMS TO A
BROAD AUDIENCE, I THINK THAT'S
GOING TO BE ESSENTIAL.
>> IT AN INTERESTING IDEA.
I'LL TAKE THAT BACK AND WE'LL
THINK ABOUT IT.
I DON'T THINK THAT WAS THE BIAS
I WAS INTENDED TO COMMUNICATE.
MY POINT WAS THAT IT'S NOT
REALLY FAIR TO COMPARE A GROUP
THAT RECEIVED FUNDS AND ONE THAT
DID NOT RECEIVE FUNDS.
I THINK A LITTLE COMMON SENSE
KNOWS THAT THAT'S GOING TO
IMPACT THEIR CAREER.
BUT I LIKE WHAT YOU'RE SAYING
AND WE'LL TI TAKE THAT BACK AND
THINK ABOUT IT.
THANK YOU.
>> THANK YOU.
SO WE'LL GO LAST TO JEN AND THEN
A SHORT ANSWER MAYBE.
>> SO THIS IS A QUICK COMMENT
AND A QUESTION, SO THE COMMENT
IS YOU GOT A QUESTION EARLIER
ABOUT WHETHER THE AWARDS ARE
AVAILABLE FOR ALL INSTITUTIONS.
AND I'M ALSO SURE THAT THE
INTENTION IS TO SUPPORT SCIENCE
THAT SUPPORTS -- OR THAT WOULD
PROVIDE HELP FOR ALL AMERICANS.
SO ON A QUICK SEARCH OF THE TAGS
LIST, WHICH ARE CANCELED GRANTS
OVER THE WEEKEND, I FOUND THAT
FIVE OF THESE AWARDS, AT LEAST
FIVE, HAVE BEEN CANCELED
RECENTLY OF THE HIGH RISK, HIGH
REWARD PROGRAMS.
SO THAT'S MY COMMENT.
MY QUESTION IS, JUST LIKE RAFAEL
ASKED WHETHER THE AWARDS WILL BE
AVAILABLE TO ALL INSTITUTIONS,
WILL THE AWARDS BE AVAILABLE TO
ALL SCIENTIFIC TOPICS?
>> SO AS I STATED BEFORE,
THEY'RE OPEN TO EVERYTHING
WITHIN THE NIH MISSION SPACE.
IF THERE ARE AREAS OF SCIENCE
THAT BY NIH POLICY WE ARE NOT
GOING TO SUPPORT, THEN THOSE
PROBABLY WILL NOT BE SUPPORTED.
>> OKAY, THANK YOU.
>> SORRY.
>> ALL RIGHT.
SO WITH THAT COMMENT, I THINK WE
CAN MOVE ON TO THE VOTE ON THIS
CONCEPT.
AND THEN AS ALREADY ALLUDED TO,
CAROLYN HUTTER WILL FOLLOW WITH
A DISCUSSION TO THE FUTURE.
WE DISCUSSED ON OUR END HOW WE
SHOULD DO THE VOTE.
WE ARE GOING TO CONTINUE WITH
THIS HAND RAISING METHOD BECAUSE
WE BELIEVE THAT IS A BETTER
OUTCOME.
LET ME FIRST CALL FOR THE MOTION
AND THEN I'LL HAND IT OVER TO
CHRISTINA FOR THE ACTUAL VOTE.
MAY I HAVE A MOTION FOR APPROVAL
OF THE OFFICE OF SCIENCE -- OSC
CONCEPT CLEARANCE ENTITLED HIGH
RISK, HIGH REWARD HRHR RESEARCH
PROGRAM.
IS THERE SUCH A MOTION?
I SEE SO MOVED.
I SEE SECOND.
THANK YOU VERY MUCH.
IS THERE ANY MORE DISCUSSION AT
THIS POINT?
I SEE NO MORE RAISED HANDS,
NOTHING IN THE CHAT.
WITH THAT, I'LL TURN IT OVER TO
CHRISCHRISTINA.
>> NO, I WAS VOTING, SORRY.
>> IT'S ALWAYS GOOD TO HAVE
MULTIPLE EYES LOOKING.
CHRISTINA, GO AHEAD.
>> THANK YOU, DR. GRIEDER.
AS MENTIONED, THIS IS A VOTE FOR
APPROVAL OF THE OSC CONCEPT
CLEARANCE TITLED HIGH RISK, HIGH
REWARD RESEARCH PROGRAM.
PLEASE RAISE YOUR HAND TO VOTE
AYE FOR THE PRESENTED CONCEPT
FLEURCHLT THANK YOU.
THANK YOU.
I SEE 16 RAISED HANDS.
PLEASE LOWER YOUR HANDS.
AND WE WILL MOVE ON TO THE NEXT
VOTE.
PLEASE LOWER YOUR HANDS.
THANK YOU.
PLEASE RAISE YOUR HAND TO VOTE
NAY FOR THE PRESENTED CONCEPT.
THANK YOU.
I DO NOT SEE ANY RAISED HANDS.
MOVING ALONG, PLEASE LOWER YOUR
HANDS IF THEY WERE RAISED.
MOVING ALONG, PLEASE RAISE YOUR
HAND TO VOTE ABSTENTION FOR THE
PRESENTED CONCEPT.
NOT SEEING ANY RAISED HANDS, THE
MOTION AS STATED HAS PASSED.
THANK YOU.
>> THANK YOU, CHRISTINA.
NICOLE?
>> THANK YOU ALL.
OKAY.
MOVING TO THE NEXT SECTION.
SO ONE OF NIH'S AND ESPECIALLY
DPCPSI'S KEY GOALS IS TO FOSTER
FUNDAMENTAL CREATIVE DISCOVERIES
IN INNOVATIVE RESEARCH
STRATEGIES.
SO ACHIEVING THIS REQUIRES A
RANGE OF APPROACHES INCLUDING
IDENTIFYING AND SUPPORTING
RESEARCH THAT HAS THE POTENTIAL
TO DISRUPT CURRENT BIOMEDICAL
PARADIGMS AND OPEN NEW PATHWAYS
FOR DISEASE PREVENTION,
DIAGNOSIS AND TREATMENT.
SO THIS TRANSFORMATIVE RESEARCH
OFTEN INCLUDES CREATIVE
APPROACHES AND SUBSTANTIAL BREAK
THROUGHS THAT CHALLENGE NORMS
AND ARISE FROM NOVEL IDEAS ON
THE EDGES OR INTERSECTIONS OF
DISCIPLINES.
SO TRANSFORMATIVE RESEARCH
INHERENTLY INVOLVES A LEVEL OF
RISK AND UNCERTAINTY AS ALSO HAS
POTENTIAL FOR EXCEPTIONALLY HIGH
IMPACT.
SO AS A RESULT, THESE HIGH RISK
HIGH REWARD INITIATIVES THAT
ALLOW FOR INCREASED INNOVATION
AND EXPERIMENTATION CAN IDEALLY
LEAD TO GROUNDBREAKING
DISCOVERIES, ADDRESS CHALLENGING
QUESTIONS AND CATALYZE
SCIENTIFIC PROGRESS.
SO THERE IS OPPORTUNITY FOR
DPCPSI TO BUILD ON THE SUCCESS
OF THE PROGRAMS SUCH AS THOSE
THAT YOU JUST HEARD ABOUT, AND
WE ARE TRYING TO EXAMINE
ADDITIONAL WAYS THAT DPCPSI
COULD ADVANCE NOVEL APPROACHES
AND OUTCOMES WORKING IN
PARTNERSHIP ACROSS ALL OF OUR
NIH INSTITUTES, CENTERS AND
OFFICES.
SO WE THINK THAT THERE IS SPACE
FOR MORE STRATEGIC OPPORTUNITY
TARGETED ON HOW WE CAN IMPROVE
AND EXPAND ON OUR EXISTING
EFFORTS, SO WE HAVE A PROPOSAL
ON HOW WE MIGHT DO THAT, WHICH
WE WOULD CERTAINLY APPRECIATE
YOUR THOUGHTS ON AND CAROLYN
WILL ELABORATE FURTHER.
SO WITH THAT, CAROLYN, THE FLOOR
IS YOURS.
>> THANK YOU.
AND THANK YOU, EVERYBODY, FOR
JOINING US THIS MORNING.
I'M VERY EXCITED THAT WE WERE
ABLE TO HAVE THIS COUNCIL OF
COUNCILS MEETING SCHEDULE.
SO AGAIN FOR THOSE OF WHO YOU
DON'T KNOW ME, I AM THE OFFICE
DIRECTOR FOR THE OFFICE OF
STRATEGIC COORDINATION, AND WHAT
I'M PRESENTING TODAY IS A
PROPOSAL FOR AN HRHR WORKING
GROUP OF THE COUNCIL OF COUNCILS
AND IF YOU GO TO THE NEXT SLIDE,
PLEASE, WE'RE WANTING TO FOCUS
THIS ON TRANSFORMATIONAL
BIOMEDICAL RESEARCH, AND I WILL
SAY THAT THE DISCUSSION THAT YOU
ALL JUST HAD AFTER TRISH AND
BECKY'S PRESENTATION REALLY SETS
THE STAGE FOR WHY WE THINK A
WORKING GROUP IN THIS AREA AT
THIS TIME WOULD BE IMPORTANT.
AS NICOLE JUST LAID OUT, THIS
WORKING GROUP WOULD BE BROADER
THAN AN ANALYSIS OF THE EXISTING
HRHR PROGRAMS AND REALLY LOOK AT
HOW DO WE THINK ABOUT INNOVATIVE
RESEARCH THAT GOES BEYOND
INCREMENTAL ADVANCES AND
CREATIVE APPROACHES IN THIS
SPACE, AND REALLY COME AFTER THE
CHALLENGES ABOUT HOW DO WE
IDENTIFY CRITICAL TOPICS AND
APPROACHES WITH POTENTIAL
IMPACT, HOW DO WE DEVELOP
APPROPRIATE MECHANISMS AND
REVIEW PROCESSES, AND BUILDING
ON THE DISCUSSION WE JUST HAD
AND CERTAINLY PART OF OUR
CONSIDERATION IN THINKING ABOUT
THIS WORKING GROUP, ALTHOUGH NOT
LISTED ON THIS SLIDE, IS ALSO
HOW DO WE EVALUATE SUCCESS.
WHAT ARE THE APPROPRIATE
METRICS, AND THE WAYS TO SORT OF
STUDY WHEN ARE WE HAVING SUCCESS
AND WHAT OPPORTUNITIES LEAD TO
SUCCESS IN THIS AREA.
SO AS WE THINK OF THE WORKING
GROUP OF THIS COUNCIL, WHAT WE
WOULD HOPE THAT WE WOULD BE ABLE
TO COME TOGETHER WITH A GROUP TO
DISCUSS IS HOW DO WE BEST FOSTER
TRANSFORMATIVE BIOMEDICAL
RESEARCH, NOT JUST I IN DPCPSI T
ACROSS NIH.
WHAT'S THE APPROPRIATE PORTFOLIO
BALANCE FOR THESE TYPES OF
EFFORTS LIKE I JUST HEARD SOME
OF THE FEEDBACK THAT MAYBE WE
SHOULD THINK ABOUT INCREASING
WHAT PORTION OF OUR PORTFOLIO
GOES TO THESE TYPES OF EFFORTS,
HOW DO WE ASSESS THAT, HOW DO WE
ASSESS WHETHER WE'RE TAKING
APPROPRIATE RISK, HOW DO WE
ASSESS WHETHER WE'RE HAVING
APPROPRIATE SUCCESS.
HOW DO WE BROADEN THE
PARTICIPATION, REALLY YOU GUYS
SET THE STAGE WITH THE KINDS OF
QUESTIONS WERE YOU ASKING ABOUT
ENSURING THAT WE'RE HITTING ALL
OF THE INSTITUTIONS, THAT WE'RE
HITTING ALL OF THE SCIENTIFIC
DISCIPLINES, AND REALLY COVERING
THE FULL TRANSLATIONAL SCIENCE
SPECTRUM, NOT JUST IN THE BASIC
SCIENCE AREA BUT ALL THE WAY
THROUGH TO IMPLEMENTATION
SCIENCE AND OTHER AREAS.
AND WHAT'S THE APPROPRIATE WAY
FOR DPCPSI TO TAKE A LEADERSHIP
ROLE IN THIS SPACE THAT WOULD
HAVE AN IMPACT ON NOT JUST
THINGS WITHIN OUR DIVISION BUT
WITHIN NIH AS A WHOLE.
SO WITH THOSE SLIDES SORT OF AS
BACKGROUND TO LET YOU KNOW WHAT
WE'RE THINKING IN THIS SPACE, WE
JUST WANTED TO OPEN IT FOR A
DISCUSSION A LITTLE BIT TO HEAR
FROM YOU ALL ABOUT WHETHER OR
NOT YOU'RE SUPPORTIVE OF OUR
PURSUING A WORKING GROUP IN THIS
AREA, AND ALSO IF THERE'S
QUESTIONS IN ADDITION TO THESE
SORT OF OPEN QUESTIONS WE'VE
OUTLINED HERE THAT YOU THINK
SUCH A WORKING GROUP SHOULD
PURSUE.
SO YOU CAN PULL THE SLIDES DOWN
AND I'M HAPPY TO TAKE FEEDBACK
AND DISCUSSION AND I SEE KEVIN
ALREADY HAS HIS HAND UP.
>> THANKS SO MUCH, CAROLYN.
YEP, LET'S OPEN IT UP FOR
QUESTIONS, COMMENTS, DISCUSSION.
KEVIN, PLEASE GO AHEAD.
>> HI, THANK YOU SO MUCH.
I WASN'T GOING TO SAY ANYTHING
OF COURSE BEFORE THIS, BUT I
HAVE BEEN THE BENEFICIARY OF ONE
DP1, SO I'M DOING WORK IN THE
SPACE OF AI AND PRIMARY CARE.
IF I WERE STAYING ON THE
COUNCIL, I WOULD DEFINITELY BE
WANTING TO BE PART OF THIS
WORKING GROUP SO I'M HAPPY --
EVEN OFF THE COUNCIL IF PEOPLE
WANT TO CHAT, I'M HAPPY TO
PARTICIPATE.
>> I DID SAY THESE WORKING
GROUPS INCLUDE BOTH INTERNAL AND
EXTERNAL TO COUNCILMEMBERS.
>> OKAY.
WELL, THEN MAYBE I'LL DO IT.
BUT -- IN FACT, I WILL DO IT.
BUT I THINK IT'S A REALLY
TERRIFIC IDEA.
I THINK BOTH THE CONVERSATION
ABOUT METRICS BECAUSE THE WORLD
HAS CHANGED AND. SO METRICS YOU
MIGHT CHOOTION TO USE ARE VERY
DIFFERENT.
I ACTUALLY HAD THOUGHT AT ONE
POINT ABOUT A REALLY INTERESTING
HURDLE FOR PIONEER AWARDEES WHO
ARE ESPECIALLY MORE SENIOR
PEOPLE TO OVERCOME BEFORE
APPLYING, AND I'D LOVE TO CHAT
WITH THE WORKING GROUP ABOUT
THAT IDEA.
I THINK -- I WAS LOOKING -- I
WAS TRYING TO CAPTURE THAT
SLIDE, CAROLYN, THAT YOU HAD UP
THAT I JUST DIDN'T CAPTURE IN
TIME TO ANSWER THE EXACT
QUESTIONS, BUT I'M VERY
SUPPORTIVE AND THINK GETTING A
WORKING GROUP INVOLVED,
ESPECIALLY GIVEN -- AND I WON'T
CALL THEM AUSTERITY MEASURES,
BUT GIVEN WHAT'S HAPPENED
RECENTLY AT THE NIH, I THINK IT
WOULD BE VERY USEFUL FOR US TO
HAVE A CONVERSATION ABOUT WHAT
THIS PROGRAM CAN OFFER IN
ADDITION TO WHATEVER OVERARCHING
ECOSYSTEM IS FOR TRAINING AND
HIGH RISK HIGH REWARD WORK.
>> GREAT.
THANK YOU VERY MUCH, KEVIN.
NEXT I SEE RHONDA WITH HER HAND
RAISED.
PLEASE GO AHEAD.
>> THANK YOU.
I FIND THIS TO BE VERY
FASCINATING, BUT A QUESTION I
HAVE FOR YOU, I REALIZE THAT
MOST OF THE PARTICIPANTS ARE
FROM NIH VARIOUS DIVISIONS.
IS THERE ANY THOUGHT ABOUT
INCLUDING OTHERS WHO ARE MAJOR
STAKEHOLDERS IN HEALTHCARE IN
GENERAL IN THIS?
BECAUSE IT CAN BRING A DIFFERENT
PERSPECTIVE OR A DIFFERENT NEED.
SO LET ME GIVE AN EXAMPLE.
CERTAINLY THE CDC CITES CHRONIC
ILLNESSES, PARTICULARLY THOSE OF
HIGH PREVALENCE, THOSE THAT HAVE
A HIGH PROPENSITY FOR DEATH, BUT
ONE OF THE THINGS THEY ARE NOT
NECESSARILY LOOKING AT AT THIS
POINT AND PROBABLY ARE NOT AWARE
OF, ARE THOSE CONDITIONS THAT
ARE INCREASING IN TREND WHERE
THE ABILITY TO IDENTIFY THEM OR
TO TREAT THEM BECOMES KIND OF A
REAL GREAT TRIAL AND ERROR
PROCEDURE.
I SAY THAT TO SAY, BECAUSE TRIAL
AND ERROR WASTES TIME BUT IT
ALSO WASTES MONEY AS IT RELATES
TO ACCOMPLISHING WHAT NEEDS TO
BE ACCOMPLISHED.
AUTOIMMUNE DISEASE IS PROBABLY A
PRIME EXAMPLE OF THAT, WHICH HAS
INCREASED IN PREVALENCE AND
SEEMS TO HAVE QUITE A FEW
DIFFERENT CONDITIONS ATTACHED TO
THAT.
SO THAT IS ONE QUESTION.
SO I'M WONDERING WHETHER OR NOT
THERE WOULD BE SOME INPUT TO
THIS GROUP IN TERMS OF WHAT ARE
SOME OF THE REAL WORLD ISSUES
THAT ARE BEING DEALT WITH BY
THOSE WHO ARE TAKING ON THE
RESPONSIBILITY, THE POPULATIONS,
NOT ONLY FROM A HEALTH OUT COME
PERSPECTIVE BUT ALSO FROM WHAT I
WOULD CALL MONETARY
RESPONSIBILITIES.
SO FOR EXAMPLE, EMPLOYERS WHO
ARE SELF-FUNDED, HEALTH PLANS,
PROVIDER GROUPS THAT ARE NOW
TAKING ON ACCOUNTABLE -- BEING
ACCOUNTABLE FOR THE POPULATIONS
THAT THEY'RE SERVICING, SO
SOMEONE GETS ILL, THIS H THEY RY
HAVE TO HELP THAT POPULATION GET
BETTER IN A CERTAIN REGARD AND
THEY HAVE TO DO IT WITHIN A
CERTAIN WINDOW OF DOLLARS WHICH
I THINK WE ALL ARE REALIZING ARE
BECOMING LESS AND LESS.
SO IS THERE ANY THOUGHT ABOUT
EXTERNAL STAKEHOLDERS HAVING
SOME INPUT, NOT NECESSARILY ON
THE COUNCIL BUT HAVING SOME
INPUT AS BEING A VERY IMPORTANT
PART OF THE DISCUSSION?
>> YES, RHONDA, I SHOULD
CLARIFY, THE WORKING GROUP
MEMBERS THAT TRISH SHARED
PREVIOUSLY, THAT'S THE GROUP
WITHIN NIH WHO OVERSEES THE HRHR
PROGRAMS -- I SEEM TO BE
FREEZING A LITTLE BIT.
I WILL ALSO TURN MY CAMERA OFF.
SO THAT OVERSEES THE HRHR
PROGRAMS THAT WE ADMINISTER.
THAT'S SEPARATE FROM THE WORKING
GROUP WE'RE TALKING ABOUT RIGHT
NOW AND 100% THE WORKING GROUP
WE'RE PROPOSING RIGHT NOW WOULD
HAVE EXTERNAL PEOPLE AND AS
WE'VE BEEN DEVELOPING A
POTENTIAL ROSTER, WE'VE BEEN
CONSIDERING NOT JUST PEOPLE IN
SORT OF THE ACADEMIC AND
TRADITIONAL FUNDING EXPERTISE,
BUT ALSO ADDITIONAL BROADER
STAKEHOLDERS.
SO I HEAR YOU IN SORT OF MAKING
SURE WE'RE REPRESENTING THE
HEALTHCARE INNOVATION AND
CONSIDERATIONS ABOUT WHAT WE
NEED TO BE DOING IN HEALTHCARE
AS ONE OF THE KEY STAKEHOLDERS
THAT WE COULD BRING INTO THIS
WORKING GROUP.
AND THIS IS A GREAT OPPORTUNITY
ACTUALLY TO GET THAT TYPE OF
EXTERNAL FEEDBACK INTO THE NIH
PROCESS.
THAT'S PART OF THE REASON TO
HAVE A GROUP LIKE THIS.
>> THANK YOU.
>> THANK YOU FOR THAT EXCELLENT
FEEDBACK.
JEAN, I SEE YOU AS THE NEXT
PERSON.
>> I DO SUPPORT WHAT RHONDA JUST
SAID.
I THINK THAT'S REALLY
INTERESTING.
I WAS REALLY ALSO THINKING ABOUT
STAKEHOLDERS.
BUT TO GO BACK TO AS WE DECIDE
ON WHAT THAT, WOULDING GROUP
SHOULD LOOK LIKE, WHEN I THINK
ABOUT HOW WE DECIDE WHAT'S A
CRITICAL TOPIC, I FEEL THAT'S
GOING TO BE PROBABLY THE MOST
IMPORTANT THING AS WE SET UP THE
WORKING GROUPS.
HOW DO WE DEFINE A CRITICAL
TOPIC, A CRITICAL TOPIC FOR YOU
MAY BE DIFFERENT FROM ME.
I THINK ABOUT IS IT THE IMPACT
IT HAS, LIKE RARE DISEASES MAY
NOT HAVE THE SAME IMPACT IN
TERMS OF NUMBERS, BUT VEL VERY
OBVIOUSLY CRITICAL FOR PEOPLE
WHO HAVE THOSE RARE DISEASES.
IT'S PROBABLY AN OUTSIDE OF THE
BOX CONVERSATION BUT HOW DO WE
DEFINE THAT, WHAT ARE THE
METRICS WE'RE GOING TO USE AND
HOPING THAT, WOULDING GROUP SORT
OF APPROACHES IT THAT WAY.
WHEN I THINK ABOUT
INTERDISCIPLINARY AND BEING AT
THE CRASS SECTION OF DIFFERENT
THINGS, IN THAT SPACE I THINK
ABOUT COLLABORATIONS, BRINGING
TOGETHER DIFFERENT GROUPS, WHAT
DO WE DEFINE AS A COLLABORATION
THAT COULD WORK, WHAT DOES THAT
LOOK LIKE, WHAT ARE WE TRYING TO
FIND.
IN THERE, I THINK ABOUT
STAKEHOLDERS LIKE INDUSTRY
PARTNERSHIPS.
SO I DON'T THINK IT NECESSARILY
IS ACADEMIC TO ACADEMIC.
IT MIGHT BE INTERESTING TO HAVE
ACADEMIC WITH INDUSTRY WHERE WE
HAVE IDENTIFIED SOMETHING THAT
IS OF CRITICAL IMPORTANCE,
BECAUSE TO ME WHEN WE DO THE
HIGH RISK REWARD KIND OF AREAS,
SOMETIMES THERE'S NO
SUSTAINABILITY IN THEM.
SO WE DO THEM, THEY GET THE
GRANT, THEY DO WHATEVER IT IS
THEY'RE GOING TO DO, AND WE
DON'T HAVE RESOURCES TO FOLLOW
UP.
SO HIGH RISK, HIGH REWARD IS
FABULOUS, BUT THEN YOU HAVE TO
GO FROM REWARD TO ACTUALLY
IMPLEMENTATION, AND THAT IS
DIFFERENT, HOW ARE WE GOING TO
LOOK AT THAT AND HOW ARE WE
GOING TO PROPOSE TO GET FROM
POINT A TO POINT B.
SO BROADENING PARTICIPATION IS
THE LAST THING I WANT TO TALK
ABOUT.
IT'S PEOPLE FROM DIFFERENT WALKS
OF LIFE, DIFFERENT PLACES,
DIFFERENT DIVERSITY PORTFOLIO,
AND I REALLY WANT US TO BE VERY
THOUGHTFUL AND DELIBERATE AND
DILIGENT ABOUT WHAT WE MEAN BY
BROADENING PARTICIPATION SMS.
SO THOSE ARE MY 2 CENTS.
>> EXCELLENT FEEDBACK.
AGAIN YOU GUYS ARE JUST ALL
HIGHLIGHTING FOR ME THROUGH YOUR
DISCUSSION MORE ENTHUSIASM AND
THE KEY CHALLENGES AND THOUGHTS
THAT WHICH SHOULD BE BRINGING
FORWARD AND GIVING GOOD
CONSIDERATION.
>> EXACTLY.
OKAY.
GREAT.
I THINK THE LAST PERSON WHO HAD
THEIR HAND RAISED FOR COMMENT IS
KENT.
KENT, WOULD YOU LIKE TO GO
AHEAD?
>> THANKS.
CAROLYN, UC DAVIS, GOOD TO SEE
YOU AGAIN.
>> GOOD TO SEE YOU, KENT.
>> JUST CLARIFICATION ON THE
BOUNDARIES OF WHAT THE WORKING
GROUP IS TO WORK WITHIN.
SO IS IT PRIMARILY A REVIEW OF
HOW THE HRHR PROGRAMS ARE NOW,
AND MAYBE HAD TO MODIFY AND
TWEAK THEM TO BE MORE
TRANSFORMATIVE, OR IS IT LOOKING
AT A WHOLESALE RESTRUCTURING AND
MAYBE THROWING OUT THE OLD AND
BUILDING SOMETHING NEW?
WHAT'S THE BOUNDARIES THAT
YOU'RE GOING TO WANT THE WORKING
GROUP TO OPERATE WITHIN?
>> RIGHT.
I DON'T NEED TO BE AN EVALUATION
OF THE EXISTING HRHR PROGRAMS AS
TRISH AND BECKY HIGHLIGHTED, WE
ALREADY DO THAT AS PART OF OUR
NORMAL EVALUATION WITHIN THE
COMMON FUND.
REALLY THE GOAL IS TO THINK
ABOUT TRANSFORMATIVE RESEARCH AT
NIH, NOT JUST FUNDED THROUGH OSC
AND DPCPSI BUT NIH BROADLY, AND
MAKE SURE AND THINK ABOUT WHAT
ELSE CAN NIH BE DOING, WHAT'S A
FORWARD LOOK AT THINGS THAT NIH
CAN AND SHOULD BE DOING IN THIS
SPACE, HOPEFULLY COMPLEMENTING
RATHER THAN REPLACING OUR
EXISTING HRHR EFFORTS.
BUT OBVIOUSLY THERE MAY BE SOME
IMPACT ON OUR EXISTING HRHR
EFFORTS BUT IT'S REALLY MUCH
MORE OF A FORWARD LOOKING WHAT
MORE SHOULD WE BE DOING RATHER
THAN A DIRECT EVALUATION OF THE
EXISTING PROGRAMS.
DOES THAT MAKE SENSE?
>> YES, OKAY.
THANK YOU VERY MUCH.
>> THANKS.
AND I THINK JUST TO SORT OF
RECAP SOME OF THE FEEDBACK THAT
WE GOT HIGHLIGHTING SORT OF THE
NEED TO INCLUDE EXTERNAL
INDIVIDUALS FROM HEALTHCARE AND
OTHER INDUSTRIES WILL REALLY
PROVIDE US WITH THAT RANGE OF
SCIENTIFIC EXPERTISE TO ENSURE
THAT WE ARE MEETING THE GOALS
THAT CAROLYN JUST LAID OUT IN
TERMS OF REALLY PUSHING THE
BOUNDARIES AND BEING
TRANSFORMATIVE IN OUR HR
PORTFOLIO.
OKAY.
I THINK THAT THAT BRINGS OUR
MORNING SESSION TO A CLOSE.
OUR OPEN SESSION TO A CLOSE.
WE'RE DOING VERY WELL ON TIME.
WE'RE 10 MINUTES AHEAD OF
SCHEDULE, SO WE GET A SLIGHTLY
LONGER BREAK.
SO WE'RE GOING TO TAKE A SHORT
BREAK BEFORE WE TRANSITION TO
THE CLOSED SESSION OF TODAY'S
MEETING.
SO I'M GOING TO ASK ALL OF OUR
COUNCILMEMBERS TO REMAIN LOGGED
IN AND MUTED.
WE WILL SEE EVERYONE BACK AT
12:15 P.M.
ONLY COUNCILMEMBERS AND NIH
STAFF WITH THE NEED TO KNOW WILL
BE PARTICIPATING IN THE CLOSED
SESSION.
FOR EVERYONE ELSE, THE OPEN
SESSION WILL RESUME AT 1:15 P.M.
THANK YOU ALL.
>> OKAY, WELCOME BACK, EVERYONE.
WE ARE RESUMING OPEN SESSION.
NOW IT IS MY GREAT HONOR AND
PRIVILEGE TO INTRODUCE OUR NEXT
SPEAKER, DR. JAY BHATTACHARYA,
THE 18TH DIRECTOR OF THE
NATIONAL INSTITUTES OF HEALTH.
PRESIDENT TRUMP NOMINATED HIM
FOR THE POSITION ON
NOVEMBER 26TH, 2024, AND THE
U.S. SENATE CONFIRMED HIM ON
MARCH 25TH, 2025.
AS DIRECTOR, DR. BHATTACHARYA IS
OVERSEEING THE NATION'S PREMIER
MEDICAL RESEARCH AGENCY.
DR. BHATTACHARYA WILL PLAY AN
INSTRUMENTAL ROLE IN SHAPING THE
AGENCY'S ACTIVITIES AND OUTLOOK
AND ENSURING THEY ALIGN WITH THE
PRESIDENT'S MAKE AMERICA HEALTHY
AGAIN COMMISSION.
A RENOWNED DOCTOR, RESEARCHER
AND HEALTH ECONOMIST,
DR. BHATTACHARYA HELD A TENURED
PROFESSORSHIP IN THE MEDICAL
SCHOOL AT STANFORD UNIVERSITY IN
CALIFORNIA.
DR. BHATTACHARYA'S RESEARCH HAS
FOCUSED ON POPULATION AGING AND
CHRONIC DISEASE, PARTICULARLY ON
THE HEALTH AND WELL-BEING OF
VULNERABLE POPULATIONS.
ENCOURAGING DIFFERENT
PERSPECTIVES WILL BE CENTRAL TO
DR. BHATTACHARYA'S APPROACH TO
LEADING NIH AS PART OF HIS
LARGER MISSION TO RESTORE PUBLIC
TRUST IN SCIENCE.
ALONGSIDE SECRETARY KENNEDY, HE
WILL CHAMPION INNOVATIVE,
CUTTING EDGE RESEARCH THAT FUELS
NEAR-TERM SOLUTIONS FOR PATIENTS
WHILE █BALANCING INVESTMENTS IN
BASIC SCIENCE.
DR. BHATTACHARYA EARNED HIS
BACHELOR'S AND MASTER'S DEGREES
IN ECONOMICS FROM STANFORD
UNIVERSITY.
HE THEN COMPLETED MEDICAL SCHOOL
AND EARNED A PH.D. IN ECONOMICS
ALSO FROM STANFORD UNIVERSITY.
DR. BHATTACHARYA, THE FLOOR IS
YOURS.
>>
>> WE CAN'T HEAR.
>> CAN YOU HEAR ME NOW?
>> YES, WE CAN.
>> OKAY.
I'M ABSOLUTELY DELIGHTED I'VE
HAD THE CHANCE TO LEAD THE NIH
AT THIS TIME.
SO FOR THIS TALK, WHAT I THOUGHT
I'D DO IS I WOULD TALK A LITTLE
BIT ABOUT MY BACKGROUND.
NICOLE MENTIONED SOME OF IT BUT
I JUST WANTED TO EMPHASIZE A
COUPLE POINTS ABOUT IT, IN
PARTICULAR MY LOVE FOR THE NIH
AND FOR THE MISSION OF THE NIH,
AND MY ABSOLUTE COMMITMENT TO
MAKE SURE THAT THE NIH CONTINUES
TO BE THE CROWN JEWEL OF
RESEARCH, BIOMEDICAL RESEARCH IN
THE WHOLE WORLD.
I'LL TALK A LITTLE ABOUT THE
LEADERSHIP TRANSITION AND OTHER
CHANGES, AND IN PARTICULAR I'LL
FOCUS ON SOME OF THE EARLY
INITIATIVES THAT I'VE WORKED ON
THAT I HOPE WE CAN GET -- THAT
WILL MAKE THE RESEARCH COMMUNITY
HAVE AVAILABILITY TO DATA AND
OTHER ACCESS TO RESEARCH
RESOURCES THAT THEY DIDN'T
PREVIOUSLY HAVE ACCESS TO, AS
WELL AS AN INITIATIVE ON THE
ETIOLOGY OF ALZHEIMER'S AND ITS
VARIOUS MANIFESTATIONS.
FINALLY, I'LL END WITH MY VISION
FOR THE NIH.
SO NICOLE MENTIONED THAT I CAME
FROM STANFORD.
I IN FACT WAS AT STANFORD FOR
ALMOST 39 YEARS, SO MY ENTIRE
OUTLOOK IS ROOTED IN THE
BIOMEDICAL COMMUNITY WHERE
STANFORD HAS PLAYED SUCH AN
IMPORTANT ROLE.
BUT I SHOULD ALSO MENTION THAT
THE NIH HAS PLAYED A
TREMENDOUSLY IMPORTANT ROLE IN
MY OWN DEVELOPMENT.
I'VE BEEN A NIH-FUNDED
RESEARCHER MY ENTIRE CAREER.
I'VE SERVED ON NIH STUDY
SECTIONS.
I'VE WORKED VERY CLOSELY WITH
NIH OFFICIALS IN MANY, MANY
DIFFERENT PROJECTS BEFORE I
BECAME THE NIH DIRECTOR.
AND I LOVE THE NIH.
IT'S TO ME AN INSTITUTION THAT I
AM ABSOLUTELY COMMITTED TO
MAKING SERVE THE AMERICAN
PEOPLE.
THE MISSION OF THE NIH IS
ABSOLUTELY THE CORE OF MY
RESEARCH AGENDA AS WELL,
RESEARCH AIMED AT IMPROVING THE
HEALTH, LONGEVITY AND WELL-BEING
OF THE AMERICAN PEOPLE.
THAT IS A MISSION I THINK THAT
WE ALL CAN AGREE ON.
AND IT'S THAT MISSION I WANT TO
MAKE BETTER WHILE I'M THE
DIRECTOR OF THE NIH.
SO FIRST SOME LEADERSHIP
TRANSITIONS.
I SHOULD MENTION FIRST, NICOLE,
ANY CONTROL KLEINKLEINSTREUER IS
THE HEAD OF DPCPSI.
SHE WAS PREVIOUSLY THE DIRECTOR
OF THE NATIONAL TOXICOLOGY
PROGRAM, INTERAGENCY CENTER FOR
THE EVALUATION OF ALTERNATIVE
AND TOXICOLOGICAL METHODS.
THERE ARE MANY LEADERSHIP
TRANSITIONS HAPPENING, AND IN
PARTICULAR, THE LEADERSHIP OF
THE INSTITUTES, I'M COMMITTED TO
A NORMAL PROCESS TO REPLACE THE
PEOPLE THAT HAVE LEFT AND
RETIRED.
THIS TIME OF TRANSITION IS, I
RECOGNIZE AND HAVE HEARD FROM SO
MANY OF MY COLLEAGUES AND
FRIENDS A TIME OF ANXIETY AND
CHANGE, BUT I WANT TO MAKE SURE
THAT EVERYONE UNDERSTANDS THAT
ALTHOUGH EVERY INCH OF THE
FEDERAL GOVERNMENT IS UNDER
SCRUTINY AND OF COURSE THE NIH
IS NOT EXEMPT, THE MISSION OF
THE NIH WILL CONTINUE.
AS WE NAVIGATE THESE CHALLENGES,
I WILL DO MY BEST TO LEAD THE
NIH WITH THE FORUMS AND
IMPLEMENT NEW POLICIES THAT
ENDEAVOR TO EARN YOUR TRUST AND
THE TRUST OF THE SCIENTIFIC
COMMUNITY.
AT THE END OF THIS, THE NIH WILL
BE A STRONGER INSTITUTION THAT
FOSTERS SCIENTIFIC DISCUSSION,
DEBATE AND ADVANCES IN NEW
TECHNOLOGIES, NEW WAYS OF
THINKING THAT MEET THE MISSION
BETTER THAN WE CURRENTLY ARE.
LET ME TALK A LITTLE BIT ABOUT A
FEW EARLY INITIATIVES I'VE
WORKED ON.
THE FIRST IS AN INITIATIVE
REQUESTED BY THE PRESIDENT OF
THE UNITED STATES TO SECRETARY
KENNEDY AND THEN TRANSMITTED TO
ME TO HAVE A -- TO INITIATE A
RESEARCH PROGRAM SO WE HAVE A
BETTER UNDERSTANDING OF THE
ETIOLOGY OF THE AUTISM SPECTRUM
DISORDERS AS WELL AS ASSOCIATED
CONDITIONS.
TO DO THIS, THE NIH IS LAUNCHING
A INITIATIVE INSIDE THE OFFICE
OF THE DIRECTOR WHERE THE GOAL
IS TO INTEGRATE DIVERSE DATA
ENABLING RESEARCHERS TO EXAMINE
COMPLEX FACTORS INFLUENCING THE
RAPID RISE IN AUTISM SPECTRUM
DISORDER.
IN 2022, THE MMWR AT THE CDC
ESTIMATED THAT AUTISM SPECTRUM
DISORDER -- THAT 1 IN
31 CHILDREN HAD SOME FORM OF
AUTISM SPECTRUM DISORDER, A VERY
SHARP INCREASE FROM PREVIOUS
YEARS.
AUTISM SPECTRUM DISORDER IS A
HIGHLY HET YOE GEE JUST
HIGH DRK DEVELOPING TREATMENTS
FOR THE RANGE OF CONDITIONS THAT
THIS DISORDER REPRESENTS.
THE NIH IS COMMITTED TO IDENTIFY
CAUSES, RISK FACTORS AND
TREATMENTS THROUGH INVESTMENTS
IN RESEARCH PROGRAMS,
COORDINATION OF INTERAGENCY
ACTIVITIES, AND COLLABORATION
WITH THE AUTISM COMMUNITY.
TO THIS END, WE'RE LAUNCHING AN
INITIATIVE TO ACCELERATE THE
UNDERSTANDING OF CAUSES AND
IMPROVEMENTS IN TREATMENT.
THIS NEW INITIATIVE WILL
IMPLEMENT LARGE SCALE EXISTING
DATA RESOURCES, AS WELL AS
RESOURCES -- DATA RESOURCES THAT
ARE AVAILABLE IN THE --
THROUGHOUT THE REST OF THE
FEDERAL GOVERNMENT AS WELL AS
THE PRIVATE SECTOR.
IF NEEDED, THE RESEARCHERS CAN
GENERATE NEW DATA THAT WILL LINK
TO THESE AND OPEN LEEM QUERY
CONTRIBUTIONS, RISK FACTORS OF
AUTISM.
TO DO THIS, WE WILL USE A RAPID
TIMELINE OF A LARGE GRANT, GRANT
PROCESS THAT WILL BE RUN THROUGH
THE OFFICE OF THE DIRECTOR.
WE WILL SUBJECT THE -- THE
EXTRAMURAL RESEARCHERS WHO APPLY
WILL BE SUBJECT TO NORMAL REVIEW
PROCESSES AND HAVE ACCESS TO THE
DATA RESOURCES WHICH I'LL
MENTION IN JUST A SECOND.
THE IDEA WOULD BE THAT SOMEWHERE
BETWEEN 10 TO 20 GROUPS OF
RESEARCHERS FROM ACROSS THE
COUNTRY, AGAIN, RUN THROUGH
NORMAL NIH PROCESSES, WOULD BE
ABLE TO ASK QUESTIONS USING
METHODS RANGING FROM BASIC
SCIENCE TO EPIDEMIOLOGICAL
APPROACHES TO OTHER MORE APPLIED
APPROACHES TO ASK WHAT CAUSES
AUTISM AND ANSWERS HOW BEST CAN
WE TREAT AND MANAGE AUTISM SO
THAT SO MANY MILLIONS OF
FAMILIES HAVE AN EASIER TIME
DEALING WITH THE PROBLEMS CAUSED
BY HAVING AN AUTISTIC CHILD.
I RECOGNIZE, OF COURSE, THAT
AUTISM IS A RANGE OF
MANIFESTATIONS RANGING FROM
HIGHLY FUNCTIONING CHILDREN TO
CHILDREN THAT ARE QUITE SEVERELY
DISABLED, AND OF COURSE THE
RESEARCH WILL ACCOUNT VERY
CAREFULLY FOR THOSE
DISTINCTIONS, THE HIGHEST
QUALITY PROPOSALS.
TO MAKE THIS HAPPEN, WHAT WE'RE
GOING TO DO AT THE NIH IS LAUNCH
A REAL WORLD DATA PLATFORM.
THE IDEA OF THE PLATFORM IS THAT
THE EXISTING DATA RESOURCES ARE
OFTEN FRAGMENTED AND DIFFICULT
TO OBTAIN.
THE NIH ITSELF WILL OFTEN PAY
MULTIPLE TIMES FOR THE SAME DATA
RESOURCE EVEN DATA RESOURCES
THAT ARE WITHIN THE FEDERAL
GOVERNMENT, ARE DIFFICULT TO
OBTAIN AND USE BY RESEARCHERS.
SO WHAT WE'RE PROPOSING IS A
TRANSFORMATIVE REAL WORLD DATA
INITIATIVE WHICH AIMS TO PROVIDE
A ROBUST AND SECURE
COMPUTATIONAL AND DATA PLATFORM
FOR CHRONIC DISEASE AND AUTISM
RESEARCH.
THIS DATA PLATFORM WILL BE
UNVEILED AND USED FOR THE AUTISM
INITIATIVE AS I MENTIONED
EARLIER, WILL ALSO BE AVAILABLE
FOR OTHER RESEARCH PROGRAMS
WITHIN THE NIH ON CHRONIC
DISEASE AND OTHER TOPICS.
THE PLATFORM WILL FACILITATE
COLLABORATION ACROSS THE
DEPARTMENT OF HEALTH AND HUMAN
SERVICES AND GOVERNMENT MORE
BROADLY TO ESTABLISH
COMPREHENSIVE HEALTH DATASETS.
THIS WILL INCLUDE CLAIMS DATA
FROM MEDICARE, MEDICAID, WE'RE
WORKING ON A MEMORANDUM OF
UNDERSTANDING WITH CMS TO
ESTABLISH BROADER DATA USE
AGREEMENTS WITHIN THE NIH FOR
THAT PURPOSE.
IT WILL INCLUDE ELECTRONIC
HEALTH RECORD DATA FROM THE
PRIVATE SECTOR.
IT WILL INCLUDE OTHER CLAIMS,
EXISTING DATA RESOURCES SUCH AS
THE GENETICS DATA THAT THE NIH
HAS, AS WELL AS TOXICOLOGY DATA
AND ENVIRONMENTAL EXPOSURE DATA
FROM ACROSS THE GOVERNMENT AND
PRIVATE RESOURCE -- PRIVATE
INDUSTRY.
MANY LEADERS IN THE DATA SCIENCE
SPACE -- ACROSS THE ICs AND SO
THIS PLATFORM LANDL WILL FEATURE
CUTTING EDGE KNOWLEDGE THAT THE
NIH ALREADY HAS.
IF YOU LOOK ON THIS FIGURE YOU
CAN SEE THE PLATFORM WILL LINK
DATA FROM REAL WORLD SOURCES
SUCH AS PHARMACY CHAINS SO YOU
HAVE MEDICATION RECORDS, HEALTH
ORGANIZATIONS LIKE INCLUDING THE
V.A., DEFENSE HEALTH AGENCY,
INDIAN HEALTH SERVICES, CLINICAL
DATA AS I ALREADY MENTIONED, THE
ELECTRONIC HEALTH RECORD SO YOU
HAVE ACCESS TO LABS, IMAGING,
GENOMICS, CLAIMS AND BILLING
DATA, WHICH OFTEN PROVIDES
DETAILED DIAGNOSTIC INFORMATION
AS WELL AS INFORMATION ABOUT USE
OF OCCUPATIONAL HEALTH AND OTHER
RESOURCES.
ENVIRONMENTAL DATA, AIR
POLLUTION, ENVIRONMENTAL TOXINS,
AS WELL AS SOME DATA ON SENSORS
AND WEARABLES LIKE SMART WATCHES
AND FITNESS TRACKERS.
BY BRINGING THESE DATA TOGETHER
IN ONE PLACE, PROVIDING ACCESS
TO ADVANCED COMPUTATION
RESOURCES AND LEVERAGING THE
LATEST TECHNIQUES, AI
TECHNIQUES, THE PLATFORM WILL
ACCELERATE RESEARCH AND CREATE
NEW OPPORTUNITIES IN REALTIME
HEALTH MONITORING DEVELOPING
NATIONAL DISEASE REGISTRIES
INCLUDING A NEW ONE FOR AUTISM,
ENABLING FASTER DRUG
DEVELOPMENT, ENABLE LONGITUDINAL
DATASETS TO BETTER UNDERSTAND
THE PROGRESSION OF DISEASE AND
LAUNCHING NATIONAL COMPETITIONS
AS WELL AS RESEARCH PROGRAMS FOR
INNOVATIVE AND CUTTING EDGE
RESEARCH TO ANSWER KEY QUESTIONS
SUCH AS THE ONE ON THE ETIOLOGY
OF AUTISM.
THE REAL WORLD DATA PLATFORM
WILL PRESERVE THE PRIVACY OF
PATIENTS WITHIN THE CONTEXT OF
THE PLATFORM ITSELF.
RESEARCHERS WILL BE ABLE TO DO
THEIR WORK ON THE PLATFORMS BUT
NOT BE ABLE TO DOWNLOAD THE DATA
THEMSELVES, AND THERE ARE STATE
OF THE ART PROTECTIONS TO MAKE
SURE THAT ALTHOUGH LINKAGES
ACROSS THE DATASETS WILL BE
PERMITTED INSIELD INSIDE THE P,
THAT THESE LINKAGES DO NOT IN
ANY WAY THRI 10 THE
CONFIDENTIALITY OF PATIENTS.
TO DO THIS, WE WILL FORM
COLLABORATIVE PARTNERSHIPS WITH
FEDERAL, STATE AND PRIVATE
ENTITIES TO EXPAND DATA
RESOURCES AND IDENTIFY
OPPORTUNITIES.
THE PLATFORM DEVELOPMENT WILL
LEVERAGE EXISTING PROGRAMS AS A
FOWN DIETION, SUCH AS THE
HEALTHY BABY AND CHILD PROGRAM,
THE PROGRAM WHICH CURRENTLY
LINKS -- AND THE NCATS N3C
PLATFORM WIS SYSTEMATICALLY
DERIVES HEALTH RECORDS FROM
DIFFERENT INSTITUTIONS AND
HARMONIZES THESE INTO DATA
ENCLAVES.
WE'LL BUILD NEW PARTNERSHIPS AND
RESEARCH OPPORTUNITIES.
THE STRATEGIC APPROACH WILL
ENABLE AGILE IMPLEMENTATION
ENGAGEMENT WITH NON-TRADITIONAL
RESEARCH PARTNERS AND SUPPORT
NIH WIDE INVOLVEMENT TO DRIVE
PLATFORM GROWTH.
I'VE ALREADY REACHED OUT ACROSS
HHS INCLUDING TO CMS AND OARL OR
ENTITIES WITHIN HHS AS WELL AS
WITHIN NIH ITSELF AND HAVE HAD
NOTHING BUT ENTHUSIASM FOR
PARTICIPATION IN THIS.
WE'VE HAD A GREAT CONVERSATION
WITH SOME OF THE FOLKS IN
MILITARY HEALTH WHO ARE ALSO
QUITE EAGER TO GET THESE DATA IN
THE HANDS OF RESEARCHERS SO THAT
WE CAN ASK QUESTIONS AGAIN NOT
JUST ABOUT AUTISM BUT ABOUT A
WHOLE RANGE OF CONDITIONS THAT
WOULD BENEFIT FROM CLOSE
ANALYSIS OF THESE DATA BY EXPERT
RESEARCHERS IN THE EXTRAMURAL
COMMUNITY.
THE PROJECT WILL HAVE PREDEFINED
MILESTONES AND CHECKPOINTS
ENSURING EFFICIENT OPERATION,
BUT THE KEY THING IS WE WILL
MAKE SURE THAT THE PROCESSES
INSIDE TO OBTAIN AND USE THESE
DATA INSIDE THE REAL WORLD DATA
PLATFORM GUARANTEE PATIENT
SAFETY, PROTECTION OF PATIENT
CONFIDENTIALITY SO WHILE
RESEARCH ACCESS WILL BE EASY,
HARMING PATIENTS AS FAR AS THE
CONFIDENTIALITY IS CONCERNED
WILL NOT BE POSSIBLE.
LAST BIT OF MY TALK, I WANT TO
TALK ABOUT FIVE MAJOR AIMS I
WOULD LIKE TO ACCOMPLISH AS NIH
DIRECTOR, AND LET ME JUST -- I
PUT THIS AS A BLUEPRINT FOR THE
FUTURE OF BIOMEDICAL RESEARCH,
BECAUSE I THINK THE NIH CAN PLAY
A TREMENDOUSLY IMPORTANT ROLE IN
SHAPING WHAT THE NEXT CENTURY OF
BIOMEDICAL RESEARCH WILL LOOK
LIKE.
SO FIRST YOU CAN PROBABLY TELL
FROM THE TIME I SPENT ON THE
AUTISM STUDY AND ON THE REAL
WORLD DATA PLATFORM, THE NIH
ABSOLUTELY MUST ADDRESS THE CAN
KEY HEALTH NEEDS OF THE COUNTRY.
SINCE 2012, THE UNITED STATES
HAS HAD FLAT LIFE EXPECTANCY.
IN A SENSE, THE KEY MISSION OF
THE NIH, ONE OF THEM WHICH IS TO
EXPAND LONGEVITY OF THE AMERICAN
PEOPLE, HAS NOT BEEN ACHIEVED,
AND WITH THE PANDEMIC, THE LIFE
EXPECTANCY COLLAPSED EVEN
FURTHER AND ONLY RECENTLY HAS IT
COME BACK UP TO THE 2019 LEVELS.
CHRONIC DISEASE PROBLEMS
INCLUDING OBESE, DIABETES, HEART
DISEASE, I CAN GO THROUGH THE
WHOLE LITANY, ARE SO PREVALENT,
AFFLICTING THE LIVES OF MILLIONS
AND MILLIONS OF AMERICANS.
THE MAKE AMERICA HEALTHY AGAIN
IDEA IS SOMETHING THAT'S
BASICALLY UNIFORMLY POPULAR.
AND THE NIH MUST PLAY A ROLE IN
MAKING SURE THAT WE FOCUS ON
THOSE DISEASES THAT MOST AFFLICT
THE AMERICAN PEOPLE.
SO THAT WE CAN IMPROVE THAT
HEALTH -- THEIR HEALTH AND
ADDRESS THE NEEDS THAT THEY
HAVE.
THE KINDS OF APPROACHES WE HAVE
WILL AIM AT NOT JUST AT THE
CUTTING EDGE RESEARCH THAT
PRODUCES EXPENSIVE NEW
TREATMENTS, BUT ALSO SCALING AND
MAKING MORE ACCESSIBLE NEW
FINDINGS THAT WILL BE AVAILABLE
TO THE WHOLE OF THE AMERICAN
PEOPLE, NOT JUST A PART.
WE HAVE TO FIND BETTER WAYS TO
PREVENT, TREAT AND CURE CHRONIC
DISEASES.
OUR RESEARCHERS ARE NOT SIMPLY
FOCUSED ON HOW TO MANAGE LATE
STAGE CHRONIC DISEASE BUT ALSO
ON HOW BEST TO PREVENT THE
DEVELOPMENT OF CHRONIC DISEASE
AND THEN THE COMPLICATIONS OF
CHRONIC DISEASE ONCE IT'S IN THE
EARLY STAGES, AND IF WE CAN FIND
CURES TO DO THAT AS WELL.
THE SECOND TENET, THE SECOND
GOAL THAT I HAVE AS NIH DIRECTOR
IS TO SOLVE THE REPLICABILITY
CRISIS THAT HAS AFFLICTED
SCIENCE FOR DECADES NOW.
IN THE EARLY 2000s, MY
STANFORD COLLEAGUE JOHN EDES
WROTE A VERY FAMOUS PAPER WHERE
HE DOCUMENTED IN VERY SIMPLE
WAYS THAT LARGE CHUNKS OF THE
SCIENTIFIC LITERATURE SIMPLY
WERE NOT RELIABLE.
THE REPLICATION CRISIS ENSUED IN
FIELD AFTER FIELD HAS UNDERMINED
THE CONFIDENCE THAT THE PUBLIC
AT LARGE HAS IN THE BIOMEDICAL
ENTERPRISE.
DURING THE COVID EPIDEMIC, THIS
BECAME VERY, VERY SEVERE, THIS
PROBLEM BECAME VERY, VERY SEVERE
WITH THE SUPPRESSION OF ABILITY
FOR PEOPLE TO DISSENT AGAINST
SCIENTIFIC DOGMA, AND THE
ELEVATION OF ESSENTIALLY
AUTHORITY RATHER THAN
REPLICATION AS THE SOURCE OF
TRUTH IN SCIENCE.
I'VE HEARD FROM DRUG DEVELOPERS
AND MANY OTHER PEOPLE WHO TELL
ME THAT THEY CAN'T REALLY MAKE
GOOD DECISIONS BASED ON THE
SCIENTIFIC LITERATURE BECAUSE
THEY DON'T TRUST IT.
AND IN FACT, DRUG DEVELOPERS
OFTEN CONDUCT THEIR OWN PRIVATE
REPLICATION EXERCISES IN ORDER
TO SEE WHETHER IT'S WORTH
INVESTING IN THE RESEARCH -- IN
THE SORT OF FOLLOW-ON FROM THE
RESEARCH ON WHICH -- IF THEY
CAN'T TRUST THE BASIC RESEARCH
BEFORE THEY MAKE THE
INVESTMENTS, THEY HAVE TO
REPLICATE IT THEMSELVES.
BUT THESE PRIVATE REPLICATION
EFFORTS DO NOT BENEFIT THE
BROADER SCIENTIFIC COMMUNITY.
WHAT I INTEND TO DO AS NIH
DIRECTOR IS TO RESTORE
REPLICATION AND REPRODUCIBILITY
OF RESEARCH AS THE CORE IDEA OF
WHAT IS SEEN AS TRUE IN SCIENCE.
IN THE PAST FEW YEARS, WE'VE
SEEN SO MANY EPISODES OF PEOPLE,
VERY PROMINENT PEOPLE ACCUSED OF
ESSENTIALLY RESEARCH FRAUD,
PEOPLE WHO HAVE LOST POSITIONS
INSIDE THE NIH ITSELF TO THESE
ACCUSATIONS.
WHEN YOU SEE SO MANY PEOPLE
FACING THIS EXACT SITUATION OF
RESEARCH FRAUD, THE PROBLEM THEN
IS NOT ACTUALLY ONE OF MORAL
FAILURE BY ANY INDIVIDUAL
SCIENTIST, BUT RATHER SYSTEMIC
FAILURE THAT PLACES RAPID
PUBLICATION OF RESULTS IN
PROMINENT PLACES AS AN INFLUENCE
AS THE WAY TO GET AHEAD IN
SCIENCE RATHER THAN THE
ESTABLISHMENT OF TRUE
SCIENTIFIC -- TRUE SCIENTIFIC
FACTS, RELIABLE, REPRODUCIBLE
SCIENTIFIC FACTS, FACTS
REPRODUCED BY OTHER GROUPS AS
THE BASIS FOR ADVANCE IN
SCIENCE.
TO CHANGE THIS, I INTEND TO HAVE
REPLICATION BECOME A CORE
ACTIVITY OF THE NIH, AND TO
REWARD SCIENTISTS WHO
PARTICIPATE IN REPLICATION
EFFORTS.
SO FOR EXAMPLE, I INTEND TO ASK
EVERY INSTITUTE TO ESTABLISH
THEIR OWN STANDARDS FOR WHAT
REPLICATION LOOKS LIKE IN THE
FIELDS THAT THEY COVER, TO FUND
RESEARCHERS AT OUR LEVEL WHO DO
REPLICATION WORK WITH THE
SCIENTIFIC COMMUNITY AT LARGE
COMPETING TO ASK WHAT ARE THE
KEY SCIENTIFIC CLAIMS IN THE
LITERATURE THAT NEED
REPLICATION, CLAIMS ON WHICH
PEOPLE MAKE DECISIONS ABOUT DRUG
DEVELOPMENT, PEOPLE MAKE
DECISIONS ABOUT THEIR HEALTH,
AND PEOPLE MAKE DECISIONS ABOUT
WHAT THE NEXT SCIENTIFIC STEPS
OUGHT TO BE.
THE PRACTICE OF DOING
REPLICATION WILL BE BECOME
SOMETHING THAT'S NORMALIZED IN
THE SCIENTIFIC COMMUNITY UNDER
MY WATCH.
SECOND, THE PROBLEM WITH
REPLICATION OFTEN IS THAT
THERE'S NO PLACE TO PUBLISH OR
GAIN SCIENTIFIC REWARDS FOR
HAVING DONE IT.
AT THE NIH, WE'RE GOING TO
ESTABLISH A JOURNAL OF WHERE
PEOPLE WHO ARE NIH-FUNDED AND
OTHERS CAN PLACE THEIR
REPLICATION WORK.
IT WILL BE A PEER-REVIEWED
JOURNAL WITH LOW GATE KEEPING SO
REPLICATION EFFORTS CAN HAPPEN
BUT IN THE CONTEXT OF A
SCIENTIFIC DISCUSSION ABOUT THE
REASONS WHY A STUDY DOESN'T
REPLICATE, WHAT THE NEXT STEPS
FOR IT SHOULD BE FOR RESEARCH
THAT DOES AND SO ON.
THERE WIT WILL BE A RESOURCE WHE
PEOPLE WHO ENGAGE AND WORK ON
REPLICATION CAN GAIN THE KINDS
OF SCIENTIFIC REWARDS THAT ARE
NOW NOT AVAILABLE TO THEM SINCE
TOP JOURNALS WILL NOT GENERALLY
PUBLISH REPLICATION WORK.
THIRD, AND THIS IS THE MOST
IMPORTANT REFORM I WANT TO
IMPLEMENT, AS THINGS
CURRENTLY -- AS REPLICATION
GOES.
AS THINGS CURRENTLY STAND,
RESEARCHERS WHO ARE SUBJECT TO
REREPLICATION, EVEN THE REQUEST
FOR REPLICATION IS A THREAT,
INSTEAD OF THE GREAT HONOR IT
ACTUALLY REPRESENTS.
WHEN A SCIENTIST HAS AN IDEA AND
IS APPROACHED BY ANOTHER
RESEARCHER FOR REPLICATION, THAT
SHOULD BE SEEN AS AN HONOR.
RATHER THAN A THREAT.
THE SCIENTIST WHO'S BEING
APPROACHED FOR REPLICATION
SHOULD RECEIVE REWARDS FOR THAT.
JUST THE KIND OF REWARDS THAT
YOU WOULD GAIN FROM A CITATION,
FOR INSTANCE, FOR A SCIENTIFIC
PAPER.
THE SCIENTISTS WHO COOPERATE
WITH THE REPLICATION EFFORTS,
SHARE DATA TRANSPARENTLY AND
ENGAGE IN GOOD FAITH IN THESE
REPLICATIONS, AGAIN, SHOULD BE
REWARDED.
I'M GOING TO STAND UP A NEW
OFFICE WITHIN THE OFFICE OF THE
DIRECTOR OF THE NIH TO MEASURE
THESE KINDS OF SCIENTIFIC --
WE'LL TAKE ADVANTAGE OF OTHER
PARTS OF THE NIH OFFICE OF THE
DIRECTOR THAT FOCUS ON
MEASUREMENT OF SCIENTIFIC
PRODUCTIVITY, BUT EXPAND THE
SCOPE TO INCLUDE PARTICIPATION
AND COOPERATION WITH RESEARCH,
WITH REPLICATION EFFORTS, DATA
SHARING AND SO ON.
THE IDEA WOULD BE THAT BY
MEASURING THESE SORTS OF PRO
SOCIAL ACTIVITIES, THOSE PRO
SOCIAL ACTIVITIES WILL BE
REWARDED IN THE BROADER
SCIENTIFIC COMMUNITY.
TO TURN AROUND THE CURRENT
SITUATION, WHICH ESSENTIALLY HAS
REPLICATION SIDELINED AND VIEWED
AS A THREAT BY PEOPLE BEING
REPLICATED AND SOMETHING THAT'S
CENTRAL AND CORE TO THE
SCIENTIFIC ENTERPRISE, SO THAT
THE SCIENTISTS THEMSELVES WILL
WANT TO BE REPLICATED, WILL SEEK
THAT REPLICATION BECAUSE IT WILL
BE THE MAIN WAY THAT SCIENTIFIC
CAREERS ADVANCE.
THE EFFECT ON FRAUD, WELL, IT
WILL UNDERCUT THE INCENTIVES TO
COMMIT FRAUD BECAUSE THERE WILL
BE VERY LITTLE REWARD FOR HAVING
PUBLISHED A PAPER THAT ISN'T
REPLICATED.
THIRD, IN WORK I'D DONE PRIOR TO
THE PANDEMIC, I ANALYZED THE NIH
PORTFOLIO OF RESEARCH ASKING HOW
NEW ARE THE IDEAS THAT
NIH-FUNDED RESEARCH ACTUALLY
SUPPORTS?
IN THE 1980s, IT TURNS OUT BY
MEASURES OF NOVELTY OF RESEARCH
IDEAS AND RESEARCH PAPERS, IT
TURNS OUT THAT SCIENTISTS IN THE
1980s FUNDED BY NIH TENDED TO
WORK ON IDEAS THAT HAD BEEN
INTRODUCED ONLY THE YEAR OR TWO
PREVIOUSLY.
THEY WERE AT THE VERY CUTTING
EDGE OF RESEARCH.
WITH A FEW EXCEPTIONS IN THE
2010s, THE NIH RESEARCH,
FUNDED RESEARCHERS WERE WORKING
ON IDEAS THAT WERE SOMEWHERE ON
THE ORDER OF SEVEN TO EIGHT
YEARS OLD.
AT THE SAME TIME, WE'D SEEN A
GREYING OF SCIENTIFIC WORKFORCE
WITH THE AGE OF FIRST LARGE
GRANT MOVING FROM THE MID 30s
IN THE 1980s TO SOMEWHERE IN
THE MID 40s.
HAVE SVERY SLOW PROGRESSION DESS
MANY EFFORTS BY THE NIH TO
REVERSE IT.
THE PORTFOLIO ITSELF HAS TENDED
TO EMPHASIZE INCREMENTAL
ADVANCES THAT ARE VERY LIKELY TO
SUCCEED, RATHER THAN A PORTFOLIO
WHERE YOU MAY HAVE FAILURES FOR
INDIVIDUAL PROJECTS IN THE
PORTFOLIO BUT THE PORTFOLIO AS A
WHOLE IS ASKING BIG QUESTIONS SO
THAT YOU HAVE THE POSSIBILITY OF
GIANT ADVANCES OF CURES FOR
DISEASES PREVIOUSLY SEEN AS
INTRACTABLE, IDEAS FOR
PREVENTION AND OTHER BOLD IDEAS.
MY GOAL WILL BE TO TRANSFORM THE
NIH DECISION-MAKING SO THAT IT
HAS MORE OF A BIAS TOWARD BOLD
AND TRANSFORMATIVE IDEAS, NOT
JUST FOR SOME OF THE MECHANISMS,
BUT FOR NEARLY EVERY MECHANISM
THAT WE DO, WE SHOULD BE AIMING
FOR THE FENCES, WE SHOULD BE
AIMING FOR HUGE ADVANCES, AND
THE CRITERIA OF SUCCESS THEN
WILL BE NOT THAT EVERY SINGLE
INDIVIDUAL PROJECT CAN SHOW SOME
SUCCESS IN PUBLISHED PAPERS.
THAT'S NOT THE KEY QUESTION.
IF A PORTFOLIO HAS EVERY ELEMENT
OF IT SUCCEED, THAT PORTFOLIO
WAS NOT TAKING A SUBSTANTIAL
ENOUGH RISK AND SWINGING FOR THE
FENCES ENOUGH TO MAKE BIG
ADVANCES.
WHAT WE WANT IS THE PORTFOLIO AS
A WHOLE TO SUCCEED RATHER THAN
JUST INDIVIDUAL SINGLE PROJECTS,
SO THE GOAL WILL BE TO TRANSFORM
THE NIH TO THINKING IN THIS WAY.
ARPA-H IS SUPPOSED TO DO THIS,
OF COURSE, BUT THERE'S NO REASON
WHY THE NIH ITSELF ALSO SHOULD
NOT BE DOING THIS.
FOURTH ITEM.
THE NIH HAS BEEN AT THE CENTER
OF THE CONTROVERSY OVER COVID
ORIGINS.
THERE ARE MANY RESEARCHERS WHO
BELIEVE THAT -- AND I RECOGNIZE
THIS IS A CONTROVERSIAL
STATEMENT, BUT MANY RESEARCHERS
BELIEVE IT'S POSSIBLE THAT COVID
ITSELF WAS THE RESULT OF
EXPERIMENTATION.
OF COURSE IN THE DECADE BEFORE
THE PANDEMIC, THERE WAS MUCH
CONTROVERSY WITHIN THE
SCIENTIFIC COMMUNITY OVER THE
CONDUCT OF GAIN OF FUNCTION
RESEARCH OF CONCERN WHERE IN
AGAIN 14, PRESIDENT OBAMA HAD
ISSUED A PAUSE ON ALL SUCH
RESEARCH.
THE REGULATION OF THIS RESEARCH
IS NOW FRONT AND CENTER OF
CONGRESSIONAL ACTION.
AS NIH DIRECTOR, I WANT TO WORK
TO MAKE SURE THAT THE RESEARCH
WE SUPPORT DOES NOT POSE ANY
RISK OR HARM AT ALL TO HUMAN
POPULATIONS.
WE SHOULD NOT BE CONDUCTING --
IT SHOULD MEET THE HIGHEST
ETHICAL STANDARD.
AT THE VERY LEAST, THE PUBLIC
SHOULD HAVE A SAY ARE THE RISK K
THAT RESEARCHERS TAKE, SO I'M
GOING TO MAKE SURE THAT I
COOPERATE WITH CONGRESSIONAL
EFFORTS AND EFFORTS BY THE
ADMINISTRATION TO REGULATE THE
RESEARCH THAT WE DO TO MEET THE
HIGHEST ETHICAL STANDARDS, AND
TO MAKE SURE THAT IT DOES NOT
ENDANGER HUMAN POPULATIONS IN
THE CONDUCT OF RESEARCH ITSELF.
THE NIH MUST FOSTER A CULTURE IN
WHICH SCIENTISTS CAN EXPRESS
DISAGREEMENT RESPECTFULLY.
PLUS EDGE COURAGE ACADEMIC
FREEDOM.
I'VE HEARD FROM SEEM INSIDE
INTRAMURAL RESEARCH, INSIDE NIH
BOTH DURING THE PANDEMIC AND
AFTER, THAT THEY OFTEN DON'T
FEEL THIS WAY.
THE CULTURE AFTER ACADEMIC
FREEDOM IN THE SCIENTIFIC
COMMUNITY I CAN ATTEST
PERSONALLY -- THE NIH MUST PLAY
A LEADING ROLE IN ENCOURAGING
ACADEMIC FREEDOM.
I'VE BEEN WORKING ON A POLICY TO
GUARANTEE, FOR INSTANCE, THAT
INTRAMURAL RESEARCHERS IN THE
NIH WILL HAVE MINIMAL OVERSIGHT
OVER WHETHER THEIR SCIENTIFIC
RESEARCH CAN BE PUBLISHED.
ONLY SUBJECT TO FEDERAL
REGULATIONS OR LAWS, BUT NO
SUBSTANTIVE OVERSIGHT, SO THAT
RESEARCHERS WHO FIND RESEARCH
RESULTS THAT, FOR INSTANCE, I
DON'T LIKE SHOULD HAVE THE
ABSOLUTE RIGHT TO PUBLISH IT
WITHOUT ANY SAY-SO ON MY PART.
THE KIND OF ACADEMIC FREEDOM
THAT I THOUGHT WE ENJOYED AS
RESEARCHERS BEFORE THE PANDEMIC
IS THE KIND OF ACADEMIC FREEDOM
THAT SAYS YOU CAN FIND WHATEVER
RESULT YOU LIKE, YOU CAN HAVE
WHATEVER DISCUSSION YOU LIKE AS
A RESEARCHER, THAT IS YOUR
ABSOLUTE RIGHT TO DO SO.
SCIENTIFIC PROGRESS DEPENDS ON
THE RIGHT FOR RESEARCHERS TO
DISSENT AGAINST SCIENTIFIC
DOGMAS.
AND THE NIH WILL WORK TO MAKE
SURE THAT INTRAMURAL RESEARCHERS
HAVE THIS KIND OF ACADEMIC
FREEDOM, AND THAT WE ENCOURAGE
THE SAME KIND OF ACADEMIC
FREEDOM IN THE EXTRAMURAL
SCIENTIFIC COMMUNITY.
NOVEL BIOMEDICAL DISCOVERIES
THAT ENHANCE HEALTH AND LENGTHEN
LIFE ARE MORE VITAL THAN EVER TO
OUR COUNTRY'S FUTURE.
BUT THAT, OF COURSE, IS THE
MISSION OF THE NIH.
I'M GOING TO END NOW AND LEAVE
TIME, A FEW MINUTES FOR
QUESTIONS.
FINAL SLIDE.
>> THANK YOU SO MUCH, JAY.
SO WE WILL NOW OPEN THE FLOOR TO
COUNCILMEMBERS FOR QUESTIONS.
MONICA, PLEASE GO AHEAD.
>> JAY, THAT WAS A GREAT TALK,
AND I WANTED TO SAY THAT I THINK
YOU ENTERED AT A DIFFICULT TIME,
BECAUSE OF CHANGES THAT OCCURRED
BEFORE YOU CAME BETWEEN THE
ELECTION AND WHEN YOU ENTERED.
AND I WANTED TO ASK ABOUT YOUR
ABILITY, I THINK YOU'VE BEEN
DOING A GREAT JOB IN INTRAMURAL
AND EXTRAMURAL TRYING TO ALLAY
SOME OF THE ANXIETIES THAT WERE
CAUSED BY, FOR EXAMPLE, GRANT
TERMINATIONS, GRANTS NOT GOING
OUT, NOFOs, LOTS OF THINGS
THAT WERE REALLY DIFFERENT FOR
THE NIH THAN HAD HAPPENED
BEFORE.
I THINK YOU'VE BEEN REALLY
TRYING YOUR BEST, YOU'VE ONLY
BEEN THERE SINCE APRIL 1ST, TO
DO WHAT YOU CAN TO ALLAY SOME OF
THOSE ANXIETYS THAT PEOPLE HAVE.
I THINK THAT, LIKE YOU SAID,
SCIENCE WILL CHANGE, BUT IT WAS
THE RAPID PACE AND ALSO AT TIMES
HAVING ADJUDICATION OF GRANTS
AND TERMINATIONS NOT BY
SCIENTISTS CREATED A LOT OF
ANXIETY.
MY QUESTION IS ACTUALLY AROUND
THE PROPOSED NIH BUDGET PASS
BACK CUTS IN THE PASS BACK --S
THAT ALMOST LEAKED LAST WEEK BUT
YOUR ABILITY AND YOUR PRESENCE
IN CONGRESS AND YOU -- WILL YOU
BE ABLE TO BE A PART OF THOSE
DISCUSSIONS WITH CONGRESS AS THE
NIH DIRECTOR WHEN THOSE COME UP
WITH THE ULTIMATE BUDGET OF THE
NIH GOING IN STARTING FROM JUNE
OF THIS YEAR, WHAT'S GOING TO BE
PROPOSED FOR THE BUDGET, WILL
YOU BE ABLE TO BE, AS YOU SAID,
IN FRONT OF CONGRESS LIKE YOU
JUST SAID?
>> CAN'T HEAR.
>> NOW WE CAN.
>> JAY, YOU'RE STILL ON MUTE.
>> OKAY.
CAN YOU HEAR ME NOW?
>> YES.
>> OKAY.
MONICA, THANK YOU FOR THAT.
IT HAS -- AS YOU SAY, IT HAS
BEEN A CHALLENGING TIME.
AND A LOT OF CHANGES HAVE TAKEN
PLACE.
SOME FOR THE BETTER, SOME FOR
THE WORSE FOR SURE.
I'VE BEEN TRYING MY ABSOLUTE
BEST TO TURN THE LIGHT SWITCHES
BACK ON.
SO FOR INSTANCE, THE DISRUPTION
IN THE SCIENTIFIC REVIEW PANELS,
WE HAVE RESOLVED I THINK BY MAY,
WE SHOULD HAVE -- WE SHOULD BE
NO LONGER BEHIND.
WE'VE MADE IT SO THE INTRAMURAL
RESEARCHERS CAN ORDER THEIR
SUPPLIES FOR THEIR LABS, WE'VE
TURNED ON TRAVEL.
I WANT SCIENCE TO CONTINUE IN
THIS COUNTRY LIKE IT'S SUPPOSED
TO, AND I'M WORKING VERY, VERY
HARD TO UNDO SOME OF THE
DISRUPTIONS THAT HAPPENED.
I THINK IN PART BECAUSE OF
MISUNDERSTANDINGS AND ALSO
ANXIETY OVER THE POLITICAL
CHANGES, A LOT OF IT HAS TO DO
WITH THAT.
AND I'VE BEEN TRYING VERY, VERY
HARD TO TURN THOSE BACK ON.
THE BUSINESS OF SCIENCE AND
BIOMEDICAL SCIENCE ABSOLUTELY
NEEDS TO CONTINUE, IT'S AN
ABSOLUTE PRIORITY OF MINE TO
THATMAKE THAT HAPPEN, MONICA.
AS FAR AS THE BUDGET PASS BACKS,
I CAN'T COMMENT SPECIFICALLY ON
THE LEAK.
NORMALLY THIS IS A PROCESS THAT
IS A NEGOTIATION BETWEEN THE OMB
AND THE AGENCIES, INCLUDING
MY -- INCLUDING THE NIH.
I SHOULD SAY JUST AS A BROAD
MATTER, I'VE SPOKEN TO MANY,
MANY MEMBERS OF CONGRESS IN THE
CONTEXT OF MY CONFIRMATION, AND
I'VE HEARD BIPARTISAN SUPPORT
FOR THE NIH CONTINUING.
AND I'VE ALSO HEARD -- I'VE SEEN
THAT PRESIDENT TRUMP WROTE A
LETTER TO THE INCOMING OSDP
DIRECTOR WITH HIS COMMITMENT
THAT THE UNITED STATES LEAD THE
WORLD IN BIOMEDICINE IN THE 21ST
CENTURY.
AND I WILL ADVOCATE TO MAKE SURE
THAT THE NIH HAS THE CAPACITY
AND THE RESOURCES TO DO THAT.
>> THANK YOU.
>> THANKS VERY MUCH.
KEVIN, DR. JOHNSON, GO AHEAD.
>> YES, HELLO.
DR. BHATTACHARYA, VERY NICE TO
MEET YOU.
I'M CURIOUS ABOUT -- I LOVE MUCH
OF WHAT YOU SAID IN TERMS OF
SOME OF THE REALLY DISRUPTIVE
APPROACHES TO KIND OF GETTING
BIG IDEAS FUNDED, GENERATED AND
SUPPORTED AS WELL AS THE IDEA OF
A JOURNAL FOR HELPING WITH
REPLICATION OF STUDIES.
ONE THING THAT I DIDN'T HEAR YOU
TALK MUCH ABOUT IS THE TRAINING
PROGRAM, AND I WAS WONDERING IF
YOU COULD JUST TALK ABOUT YOUR
VIEW OF HOW THE NIH SHOULD BE
INVOLVED IN TRAINING PEOPLE.
ESPECIALLY GIVEN THIS POTENTIAL
FOCUS ON BIG IDEAS AT A TIME
WHEN TRAINEES GETTING THEIR
FIRST GRANTS PROBABLY WON'T COME
UP WITH BIG IDEAS.
>> THANK YOU, DR. JOHNSON.
I APPRECIATE THE QUESTION.
I ABSOLUTELY THINK --
[INAUDIBLE]
>> CAN'T HEAR VERY WELL.
>> WE CAN'T HEAR YOU.
>> YOUR VOLUME HAS GONE DOWN
AGAIN.
>> I DON'T KNOW WHAT I'M DOING
WRONG, YOU GUYS.
SORRY.
HOPHOPEFULLY YOU CAN HEAR ME NO.
>> YES.
>> OKAY.
I GUESS I JUST NEED TO LEAN
FORWARD.
DR. JOHNSON, THANK YOU FOR THAT
QUESTION.
IT IS ABSOLUTELY VITAL THAT OUR
TRAINING PROGRAMS TRAIN THE NEXT
GENERATION OF SCIENTISTS AND
ENABLE THEM TO TRY THEIR IDEAS
OUT.
I'VE DONE SOME RESEARCH AGAIN
BEFORE THE PANDEMIC ASKING
WHETHER IT WAS EARLY CAREER
SCIENTISTS OR LATER CAREER
SCIENTISTS WHO WERE MORE LIKELY
TO TRY OUT IDEAS ON THE CUTTING
EDGE IN THEIR OWN PUBLISHED
WORK.
THE FACT, SLIGHTLY -- WITH GREY
HAIR LIKE ME IS THAT IT'S EARLY
CAREER SCIENTISTS WHO TEND TO
WORK ON THE NEWER IDEAS, WHO
WORK ON THE EDGE.
IN FACT, IT'S EARLY CAREER
SCIENTISTS, WOULDING WITH MID
CAREER SCIENTISTS TOGETHER THAT
ARE THE GROUP THAT ARE MOST
LIKELY TO TRY OUT IN IDEAS.
NEW IDEAS.SO FOR ME, IT IS ABSOY
VITAL THAT WE ENABLE EARLY
CAREER SCIENTISTS TO PROGRESS
INTO INDEPENDENCE AS RAPIDLY AS
THEY CAN.
WHILE STILL MAINTAINING SORT OF
THE WISDOM AND OVERSIGHT OF
LATER CAREER SCIENTISTS IN
COLLABORATION.
TO DO THIS, I'M NOT SURE EXACTLY
HOW TO AB PUBLISH PUBLISH THIS,
DR. JOHNSON, BUT SOME OF THE
IDEAS -- AT THIS POINT I'M NOT
SURE THIS IS -- IF ANY OF THIS
IS READY FOR PRIME TIME BUT I'LL
JUST TELL YOU WHAT I'VE BEEN
THINKING.
EVALUATING RESEARCH PROJECTS ON
THE ADVANCE OF POSTDOCS IN
INDEPENDENCE, HAVING Ks BE
INSTITUTED, HAVING MORE
INSTITUTIONAL K AWARDS RATHER
THAN THE INDIVIDUAL SO WHEN AN
EARLY CAREER INVESTIGATOR IS
HIRED AT AN INSTITUTION, THEY
CAN JUST HAVE THE RESEARCHER GET
THE EARLY CAREER SUPPORT
IMMEDIATELY RATHER THAN HAVING
TO GO THROUGH A LONG K
APPLICATION WHICH SOMETIMES
TAKES YEARS, ALLOWING
RESEARCHING THAT HAVE TRAINING
SUPPORT TO APPLY FOR R LEVEL
FUNDING RATHER THAN MAKING THAT
A RESTRICTION.
I'M HOPING FOR LOTS AND LOTS OF
IDEAS FOR THIS.
THINK IT'S ABSOLUTELY ESSENTIAL
FOR THE FUTURE OF BIOMEDICINE
THAT WE UNLEASH THE IDEAS OF THE
EARLY CAREER SCIENTISTS.
I FULLY EXPECT MOST OF MY IDEAS
TO BE COMPLETELY OVERTURNED, IF
NOT, THEN WE HAVEN'T DONE A GOOD
ENOUGH JOB.
>> OKAY, GREAT.
RAFAEL IS NEXT.
>> HI, THANKS.
CONGRATULATIONS ON YOUR
APPOINTMENT AND THANK YOU FOR
YOUR THOUGHTFUL REMARKS.
I WAS PARTICULARLY PLEASED TO
HEAR THAT REPRODUCIBLE RESEARCH
IS A PRIORITY.
THAT'S AN AREA I THINK DEEPLY
ABOUT AND IT'S ONE OF THE
MISSIONS OF MY ROLE AS CHAIR, IS
TO MAKE THAT BETTER AT MY
INSTITUTION.
SO I WANT TO EXPRESS MY FULL
SUPPORT AND HELP TO ADVANCE THAT
ROLE IN THE COUNCIL.
I ALSO WAS ENCOURAGED BY YOUR
WORDS ON ACADEMIC FREEDOM.
SUPER IMPORTANT.
SO I'M ALSO ENCOURAGED TO HEAR
THE CONTINUED COMMITMENT TO THE
IMPORTANCE OF FUNDING, AND I'M
CONFIDENT THAT THIS REMAINS ONE
OF THE MOST VALUABLE INVESTMENTS
WE MAKE AS TAXPAYERS.
SO NOW WHILE INCREASED SUPPORT
AND INVESTMENT IS, OF COURSE,
WELCOMED BY SCIENTISTS, I ALSO
WANT TO EXPRESS MY CONFIDENCE IN
THE RESILIENCE AND CREATIVITY OF
OUR CURRENT WORKFORCE TO ADOPT
AND MAKE MEANINGFUL USE OF
AVAILABLE RESOURCES EVEN IF THEY
ARE REDUCED.
SO WITH THAT ALL SAID, I WANT TO
SHARE ONE CONCERN I HOPE YOU CAN
HELP WITH AND MAYBE YOU CAN
SHARE YOUR THOUGHTS ON THE TOPIC
AND IT HAS TO DO WITH THE
CURRENT UNCERTAINTY.
MONICA MADE SOME REMARKS ABOUT
THAT, AROUND FUNDING LEVELS AND
AREAS OF RESEARCH THAT WILL NO
LONGER BE SUPPORTED, ALSO
INSTITUTIONAL ELIGIBILITY TO
THESE FUNDS.
SO THIS UNCERTAINTY MAKES IT
DIFFICULT TO PLAN STRATEGICALLY,
WHETHER IT IS HIRING OR
COLLABORATIONS OR LONG TERM
RESEARCH COMMITMENTS, SO ANY
CLEARER GUIDANCE YOU CAN GET
FROM THE NIH, I THINK COULD BE
VERY HELPFUL.
SO THANK YOU AGAIN FOR YOUR
LEADERSHIP AND FOR TAKING THE
TIME TO ENGAGE WITH COUNCIL.
I LOOK FORWARD TO SUPPORTING
YOUR EFFORTS HOWEVER I CAN AND
TO HEARING YOUR ANSWERS TO THESE
QUESTIONS.
THANK YOU.
>> RAFAEL, THANK YOU FOR THAT.
AS I SAID, I COME FROM ACADEMICS
MYSELF, SO I UNDERSTAND ENTIRELY
WHAT YOU MEAN ABOUT THE
UNCERTAINTY.
THIS IS THE MAIN REASON I WANT
TO START PUSHING AS HARD AS I
CAN TO RESTORE REGULAR ORDER.
EVEN IF WE ARE CHANGING AND
SHIFTING SOME RESEARCH EMPHASES
TOWARDS THIS MAKE AMERICA
HEALTHY, AS LONG AS YOU CAN PLAN
AROUND IT, YOU CAN DEVOTE YOUR
TIME AND EFFORTS TO IT.
SO I MEAN, I THINK THERE'S BEEN,
I THINK, TWO CLASSES OF
DISRUPTIONS.
ONE, I THINK HEALTHY AND ONE
LESS HEALTHY.
ONE IS THE EMPHASIS ON MAKE
AMERICA HMAKEAMERICA HEALTHY ANY
TOWARDS POLITICIZED IDEAS
TOWARDS RESEARCH THAT IS
DIRECTLY AIMED AT THE MELT
HEALTH FLEEDZ NEEDS OF THE AMERN
PEOPLE, I THINK THAT'S A HEALTHY
THING.
THAT'S AUTOMATICALLY GOING TO
CAUSE SOME DISRUPTIONS BECAUSE
THE KINDS OF RESEARCH PROJECTS
THAT SORT OF ARE, FOR INSTANCE,
FOLLOW A STYLE OF THE
PRESIDENT'S EXECUTIVE ORDERS,
YOU'RE GOING TO HAVE LESS OF
THAT, BUT AT THE SAME TIME, THE
COMMITMENT TO MAKE SURE THAT
EVERY SINGLE AMERICAN, NO MATTER
WHAT THEIR RACE, SEX, YOU KNOW,
THEIR SEXUAL ORIENTATION OR
WHATNOT, THAT THEIR HEALTH NEEDS
ARE REFLECTED IN THE PORTFOLIO
OF THE NIH, I REMAIN ENTIRELY
COMMITTED TO THAT.
AND SO I THINK THAT IS GOING TO
BE ULTIMATELY A HEALTHY
TRANSITION SO THAT THE
RESEARCHERS OF THE COUNTRY
PERCEIVED SUPPORT FOR THE NIH
ARE FOCUSED ON THE ACTUAL HEALTH
NEEDS OF THE AMERICAN PEOPLE
RATHER THAN FIGHTING POLITICAL
BATTLES THAT WE'RE ILL EQUIPPED
TO FIGHT.
THE SECOND SORT OF LESS HEALTHY
PART OF IT HAS BEEN DISRUPTIONS
I THINK CAUSED BY THE FACT
THAT -- JUST TO BE VERY BLUNT,
THERE'S A LOT OF DISTRUST,
MUTUAL DISTRUST BETWEEN FOLKS
WHO VOTED FOR PRESIDENT TRUMP
AND GENERALLY THE SCIENTIFIC
COMMUNITY.
THE SCIENTIFIC COMMUNITY, I
LOOKED AT SOME OF THE PEW
ESTIMATES OF THE PUBLIC
CONFIDENCE IN THE SCIENTIFIC
COMMUNITY TO ACT IN IT IN THE
BEST INTEREST OF THE PUBLIC, AND
THEY'RE SHOCKINGLY LOW.
I THINK IT'S LIKE LESS THAN 1 IN
4 AMERICANS ACTUALLY BELIEVE
THAT SCIENTISTS WORK FOR THE
BENEFIT OF THE AMERICAN PEOPLE.
ON THE OTHER SIDE, OF COURSE,
SCIENTISTS HAVE DEEP DISTRUST OF
THIS ADMINISTRATION FOR BETTER
OR WORSE.
I THINK A LOT OF THE DISRUPTIONS
HAVE HAPPENED BECAUSE OF THAT
DISTRUST, AGAIN ON BOTH SIDES.
I DON'T KNOW IF I CAN ACCOMPLISH
THIS, BUT WHEN MY GOAL IS TO TRY
TO BUILD A BRIDGE, BECAUSE I
DON'T SEE IN PRESIDENT TRUMP OR
IN THE FOLKS WHO I'VE INTERACTED
WITH ANY DESIRE TO REMOVE
SUPPORT, PUBLIC SUPPORT FOR THE
BIOMEDICAL ENTERPRISE.
IN FACT, QUITE THE OPPOSITE.
BASICALLY UNIVERSALLY, I THINK
IF THE BIOMEDICAL ENTERPRISE IS
WORKING FOR THE ADVANCEMENT OF
THE HEALTH OF THE AMERICAN
PEOPLE, WE'RE GOING TO GET
UNIVERSAL SUPPORT FOR IT.
AT THE SAME TIME, SCIENTISTS
NEED TO UNDERSTAND THAT WHAT
HAPPENED ESPECIALLY DURING THE
PANDEMIC HAVE REALLY DRIVEN A
WEDGE BETWEEN SCIENTISTS AND THE
AMERICAN PUBLIC.
TO SORT OF TALK IN WAYS THAT ARE
MORE RESPECTFUL FOR THE CONCERNS
THE AMERICAN PUBLIC HAS.
TALK AND WORK IN WAYS THAT ARE
RESPECTFUL THE WAY -- BUT THAT'S
MY GOAL, IS TO BUILD THAT
BRIDGE.
I DO THINK THAT SCIENCE CAN'T
WORK WITHOUT SUPPORT -- AMERICAN
SCIENCE CAN'T WORK WITHOUT
SUPPORT OF THE AMERICAN PUBLIC,
AND AMERICAN SCIENTISTS, IN
EXCHANGE FOR THE TREMENDOUS
SUPPORT THAT WE DO GET FROM THE
AMERICAN PUBLIC, OWE TO THE
AMERICAN PUBLIC TO DEVELOP
INCREASING LIFE EXPECTANCY
ANSWERS TO THE CHRONIC DISEASE
PROBLEMS THEY FACE, AND AVOID
THE SORT OF POLITICIZATION OF
SCIENCE, I THINK HAS LED TO THIS
MOMENT.
>> THANK YOU.
>> GREAT.
I RECOGNIZE WE ARE AT TIME FOR
THIS SESSION BUT THIS IS
OBVIOUSLY A REALLY CRITICAL
DIALOGUE.
AND SO IF JAY CAN CONTINUE FOR A
FEW MINUTES, WE ARE MORE THAN
HAPPY TO CONTINUE TO EXTEND THIS
SESSION.
SO I'LL TURN IT OVER TO KENT,
WHO'S NEXT.
>> HI, DR. BHATTACHARYA.
THANKS SO MUCH FOR COMING.
I THINK WE ALL SHARE YOUR LOVE
FOR THE NIH, AND WANT TO REMAIN
A CROWN JEWEL IN THE FEDERAL
GOVERNMENT, AND I THINK YOU'LL
FIND US ALL ON COUNCIL OF
COUNCILS DOING EVERYTHING WE CAN
TO SUPPORT YOUR EFFORTS TO
ENSURE THAT HAPPENS.
VERY BRIEFLY, I THINK I'M THE
ONLY VETERINARIAN ON THE
COUNCIL.
AND SO I WANTED TO ASK YOU ABOUT
ANIMAL RESEARCH.
AS YOU KNOW, DPCPSI SUPPORTS A
LOT OF ANIMAL RESEARCH IN THE
BIOMEDICAL RESEARCH FIELD,
INCLUDING TRAINING.
THOSE WHO WERE USING ANIMALS AND
VEAT NARIANS USING ANIMALS FOR
RESEARCH.
AND VETERINARY TRAINING.
SO COULD YOU COMMENT ON YOUR
PERSPECTIVE ON SUPPORT FOR
ANIMAL RESEARCH, DO YOU FORESEE
ANY CHANGES COMING UP, IS THE
REORGANIZATION THAT MAY BE
HAPPENING AT NIH MIGHT IMPACT IT
THAT?
ANY COMMENTS YOU MIGHT HAVE
BECAUSE IT IS A VERY IMPORTANT
SUBJECT.
THANK YOU.
>> THANK YOU, KENT.
SO THIS IS AN AREA WHERE I'M
STILL LEARNING, SO I'LL JUST
START WITH THAT.
AS A GENERAL MATTER, I THINK
THAT ANIMAL RESEARCH SHOULD BE
RESERVED FOR -- WHERE THERE
REALLY ISN'T AN ALTERNATIVE.
MY UNDERSTANDING IS THAT IN
RECENT YEARS, TH THEY HAVE BECOE
AVAILABLE ALTERNATIVES IN MANY
CASES.
I DON'T THINK WE SHOULD BECOME
DOGMATIC BUT IT BUT I DO THINK
WE SHOULD HAVE AN UNDERSTANDING
ABOUT THE ETHICAL CONCERNS MANY
DO HAVE ABOUT ANIMAL RESEARCH,
AND AGAIN, JUST RESERVE IT FOR
WHEN THERE REALLY ISN'T AN
ALTERNATIVE.
FOR THIS ACTUALLY MAYBE I CAN
ASK NICOLE TO WEIGH IN.
NICOLE HAS BEEN WORKING ON THIS
AREA QUITE EXTENSIVELY FOR YEARS
AND SHE IS GOING TO BE A CLOSE
ADD VIE TORADVISOR TO ME ON THI.
>> ABSOLUTELY.
HAPPY TO WEIGH IN.
THANK YOU.
SO AS YOU INDICATED, KENT,
ANIMAL RESEARCH HAS FOR DECADES,
YOU KNOW, SUPPORTED ADVANCES IN
BIOMEDICAL RESEARCH BUT I THINK
WE HAVE INSIGHTS FROM THE DRUG
DISCOVERY SPACE AND FROM THE
ENVIRONMENTAL TOXICOLOGY AND
HEALTH SPACE THAT DEMONSTRATE TO
US THAT WE CAN LEVERAGE ADVANCES
IN SCIENTIFIC DISCOVERY TO
ACTUALLY DO BETTER AND TO MOVE
TOWARDS MORE HUMAN BIOLOGY-BASED
METHODS WHETHER THAT'S
COMPUTATIONAL MODELS, COMPLEX IN
VITRO SYSTEMS, LIKELY INT
GRAITION OF ALL OF THOSE TYPES
OF TECHNOLOGIES.
YOU PROBABLY REMEMBER AND OTHERS
MAY THAT MY FIRST INTERACTION
WITH COUNCIL OF COUNCILS
ACTUALLY WAS TO DISCUSS THE
CONCEPT OF THE COMPLEMENT ANIMAL
RESEARCH AND EXPERIMENTATION,
THE COMPLEMENTARY COMMON FUND,
WHICH IS NOW A FULL-FLEDGED
PROGRAM AND IS IN THE PROCESS OF
REVIEWING APPLICATIONS AND
MAKING AWARDS SOON FOR REALLY
EXCITING NEW TECHNOLOGY VEMMENT
CENTERS AND A PART WILL BE A
QUALIFICATION AND VALIDATION
NETWORK TO DEVELOP VALIDATION
DATA PACKAGES TO HELP ENSURE
THAT THOSE NEW APPROACH METHODS
ARE REALLY ROBUST AND RELIABLE
AND REPLICABLE AND THEN CAN BE
TRANSLATED INTO BETTER PUBLIC
HEALTH PROTECTION AND ADDITIONAL
HUMAN BIOLOGY-BASED INSIGHTS IN
THE BIOMEDICAL RESEARCH ARENA.
MANY OF YOU MAY HAVE ALSO SEEN
THE PRESS RELEASE AND THE
SCIENTIFIC ROAD MAP THAT THE FDA
PUT OUT TWO WEEKS AGO WHERE THEY
REALLY HIGHLIGHTED THEIR
INTENTION TO PUT MUCH MORE
SUPPORT AND RESOURCES TOWARDS
SUPPORTING THIS TRANSITION
TOWARDS BIGGER AND BETTER
RELIANCE ON NEW APPROACH METHODS
FOR PRE-CLINICAL SAFETY TESTING
BEGINNING WITH MONOCLONAL
ANTIBODIES BUT THEY ALSO ALLUDED
TO KIND OF A GENERALIZATION
ACROSS THE PRE-CLINICAL SAFETY
SPACE TO HELP ENABLE BETTER DRUG
DISCOVERY AND HUMAN RELEVANT
SAFETY ASSESSMENTS, AND THEY
CALLED OUT NIH AS A PARTNER, A
REALLY CRITICAL PARTNER.
THEY ALSO CALLED OUT THE
INTERAGENCY COORDINATING
COMMITTEE FOR THE VALIDATION OF
ALTERNATIVE METHODS, WHICH AS
YOU KNOW IS A COMMITTEE MANDATED
BY CONGRESS THAT SPANS ACROSS 18
DIFFERENT FEDERAL PARTNERS
ACROSS THE GOVERNMENT, AND SO I
THINK THERE'S A LOT OF MOMENTUM
IN THIS SPACE, AND THERE'S GOING
TO CERTAINLY BE I THINK A
RENEWED FOCUS AND ENERGY PUT
INTO ENSURING THAT WE ARE USING
THE BEST SCIENCE POSSIBLE TO
SUPPORT BIOMEDICAL RESEARCH,
MECHANISTIC INSIGHTS AND
DISCOVERIES AND PUBLIC HEALTH
PROTECTION.
>> THANKS, I'M ENCOURAGED TO
HEAR THE MENTION OF THE NEED FOR
VALIDATION OF THE NAMs, VERY
IMPORTANT BEFORE TRANSITIONING
TO HUMAN USE, SO WONDERFUL.
THANKS VERY MUCH, BOTH.
>> THANK YOU.
RHONDA, PLEASE GO AHEAD.
>> THANK YOU SO MUCH.
I REALLY APPRECIATE THE VISION
THAT YOU'VE BROUGHT FORWARD, AND
I CAN SAY -- I ALMOST WANT TO
SAY HALLELUJAH FROM SOME DEGREE
FROM THE STANDPOINT MANY OF THE
THINGS YOU MENTIONED HAVE BEEN
LONG TERM THINGS I HAVE OBSERVED
BUT ALSO WONDERED WHETHER OR NOT
THERE WOULD BE EVER A CHANGE.
THE FIRST THING IS
REPRODUCIBILITY.
I'VE BEEN WITH THE NIH IN
ADVISORY CAPACITY NOW, TOTAL
YEARS, 12 YEARS, AND THE WHOLE
ISSUE OF REPRODUCIBILITY HAS
ALWAYS BEEN A THORN IN THE SIDE,
PRIMARILY BECAUSE I WAS ALWAYS
TOLD IT WAS NOT FUNDED BY NIH.
THE PROBLEM WITH THAT IS THAT
THE ADOPTION OF RESEARCH THAT
SHOWS REALLY GOOD PROMISE IS
HARD TO MAKE THAT TRANSLATION
INTO THE ARENA OF THE REAL
WORLD, ACCEPTING THAT PARTICULAR
RESEARCH.
SO I REALLY, REALLY SUPPORT WHAT
YOU'RE SAYING.
I WOULD ALSO ADD THAT MAYBE AS
PART OF THIS REPRODUCIBILITY,
THAT THE NEXT STUDY ALSO BE DONE
IN THE REAL WORLD SETTING WITH
LARGE NUMBERS.
THAT'S ONE OF THE THINGS THAT
MANY TIMES IS ABSENT,
PARTICULARLY IF I IT'S RELEGATED
TO AN ACADEMIC SETTING THAT
DOESN'T HAVE THE REACH, AS SOME
OF THE OTHER PLAYERS IN THE
FIELD LIKE HEALTH SYSTEMS,
INSURANCE COMPANIES, EMPLOYER,
ALL OF THEM HAVE LARGER REACH,
MANY OF THEM HAVE THE DATA THAT
YOU'RE TALKING ABOUT, AND
CERTAINLY CAN AND HAVE BEEN
ENGAGED IN REPRODUCING RESEARCH
ON THEIR OWN.
SO I JUST WANT TO BRING THAT UP
TO SAY.
ALSO, YOUR EMPHASIS ON DATA,
DATA TRANSPARENCY, AND I'M
HOPING WITH THAT SOME
STANDARDIZATION SO THAT THOSE
THAT ARE ENGAGED IN RESEARCH ARE
USING SOME STANDARD PARAMETERS
THAT WILL ALLOW THERE TO BE
CROSS COMPARABILITY ACROSS MANY
OF THE POPULATIONS AND MANY OF
THE STUDIES THAT ARE OUT THERE.
I PARTICULARLY WANT TO MENTION
ALL OF US AS BEING A VERY GOOD
EXAMPLE OF BEING ABLE TO USE
THEIR ABILITY TO RECRUIT THE
PUBLIC, BUT ALSO BEGINNING TO
RECRUIT OTHER PARTNERS IN THIS
TYPE OF VENTURE WHERE YOU'RE
COLLECTING A WIDE RANGE OF
INFORMATION, ALLOWING
RESEARCHERS TO GO IN AND BEGIN
TO CREATE NOVEL IDEAS AND
FINDINGS WHICH IS VERY, VERY
EXCITING AND I THINK THAT IS ONE
OF THE THINGS THAT IS VERY, VERY
IMPORTANT AND CERTAINLY HAS BEEN
DONE WELL BY NIH.
THE LAST PIECE I HAVE IS AROUND
COMMUNICATION.
I THINK ONE OF THE THINGS THAT
IS CERTAINLY WITHIN NOT WITHOUT
A LOT OF EFFORT ON MANY PARTS OF
NIH AS WELL AS NATIONAL ACADEMY
OF MEDICINE AND OTHERS HAVE BEEN
IN THOSE CIRCLES, IT SEEMS AS
THOUGH WE'RE NOT ABLE TO
COMMUNICATE EFFECTIVELY WITH THE
PUBLIC TO HELP THEM UNDERSTAND.
AND I THINK YOU'RE ABSOLUTELY
RIGHT, THAT THIS TRUST THAT GREW
TREMENDOUSLY DURING THE COVID
ERA HAD A LOT TO DO WITH NOT
UNDERSTANDING, NOT EVEN
REALIZING THAT SCIENCE IS
ITERATIVE, PLRLY WHEN IT'S
SOMETHING NEW.
YOU DON'T HAVE THE ABSOLUTE
ANSWERS AT THAT POINT, BUT THE
PUBLIC WASN'T LISTENING OR
HEARING OR UNDERSTANDING THAT.
SO I'M HOPING THAT PART OF YOUR
INITIATIVE WILL DEVOTE TIME,
EFFORT AND RESOURCES TO BEING
ABLE TO COMMUNICATE ON A
LAYMAN'S LEVEL TO HELP BUILD
THEIR LITERACY AS IT RELATES TO
WHAT IS BEING DONE SO THERE'S
MORE ACCEPTANCE OF THE FINDINGS
THAT COME WITH TIME.
SO AGAIN, THANK YOU SO MUCH FOR
YOUR IDEAS, BECAUSE I THINK
THEY'RE DEFINITELY WELL NEEDED
AND I CERTAINLY SEE THIS AS
BEING EXCEPTIONAL.
I WORK WITH UNITED HEALTH GROUP,
AND THINGS THAT YOU'RE TALKING
ABOUT ARE DEFINITELY THE THINGS
THAT ARE VERY, VERY IMPORTANT
FROM MY STANDPOINT OF VIEW AND
OUR ORGANIZATION.
THANK YOU.
>> RHONDA, THANK YOU FOR THOSE
COMMENTS.
I DON'T HAVE MUCH TO ADD OTHER
THAN LET'S WORK TOGETHER ON
THESE THINGS.
THE AVAILABILITY, DATA RESOURCES
AT SCALE FOR RESEARCHERS MORE
EASILY, REPRODUCIBILITY,
STANDARDS OF REPRODUCIBILITY FOR
THE DIFFERENT DISCIPLINES AND
INSTITUTES, ALL THOSE ARE QUITE
IMPORTANT TO ME.
I THINK AS FAR AS THE LAST
COMMENT ABOUT LIKE PUBLIC TRUST,
ONE IDEA THAT I HAD WAS THAT
BEFORE I BECAME NIH DIRECTOR, I
WAS RUNNING PODCAST WITH THE
NAME ILLUSION OF CONSENSUS,
ANOTHER, SCIENCE FROM THE
FRINGE.
I'D LIKE TO USE SOME OF THOSE
SKILLS THAT I GAINED
INTERVIEWING SCIENTISTS.
THE AIM OF THOSE PODCASTS WAS
THE PUBLIC AT LARGE, TO BRING
SCIENTIFIC IDEAS THAT PEOPLE
MAYBE HADN'T SEEN TO THE
ATTENTION OF THE PUBLIC IN A WAY
THAT'S UNDERSTANDABLE TO THE
PUBLIC.
I THINK OUR SCIENCE
COMMUNICATION EFFORTS AT THE
NIH, IT'S SOMETIMES DIFFICULT
FOR ME ON THE OUTSIDE TO TELL
WHO THEY'RE AIMED AT.
ARE THEY AIMED AT OTHER
SCIENTISTS, THE PUBLIC, IF IT
WAS THE PUBLIC, I OFTEN VIEWED
IT AS LIKE THE PEOPLE -- THAT WE
WERE TALKING DOWN TO REGULAR
PEOPLE RATHER THAN TRYING TO
TALK WITH THEM.
SO I WANT TO WORK TO FIX THAT.
I MEAN, I THINK OUR
COMMUNICATION WITH SCIENTISTS IS
ACTUALLY PRETTY GOOD, AND WE
HAVE PUBMED, FOR INSTANCE, WE
CAN COMMUNICATE WITH SCIENTISTS
ALL THE TIME IN LANGUAGES THAT
SCIENTISTS BENEFIT FROM AND
UNDERSTAND.
WE CAN DO BETTER FOR SURE.
BUT OUR COMMUNICATION WITH THE
PUBLIC, I THINK, NEEDS
IMPROVEMENT, AND I'M GOING TO
WORK HARD ON THAT.
>> ONE THING I WOULD SUGGEST,
THINK ABOUT WHAT THE PUBLIC GOES
TO.
I KNOW IT MAY SOUND LIKE A DIRTY
WORD, BUT SOCIAL MEDIA IS SO
STRONG, AND CERTAINLY A AVENUE
THAT THEY GO TO.
THEY JUST DON'T HAVE SOMETHING
THAT GIVES THEM A SEAL OF
APPROVAL THAT THIS IS LEGIT, AND
THAT THIS MAKES SENSE.
SO I'M JUST GONNA SAY THAT AND
LEAVE THAT ALONE.
>> I THINK WE HAVE NO CHOICE.
WE HAVE TO DEAL WITH THE PUBLIC
WHERE THEY ARE.
I ACTUALLY LIKE SOCIAL MEDIA.
I FOUND TWITTER TO BE A VERY
EFFECTIVE WAY TO REACH THE
PUBLIC BEFORE I BECAME NIH
DIRECTOR.
WE NEED TO UPDATE OUR STRATEGY
SO THAT WE REACH THE PUBLIC
WHERE THEY ARE IN THE LANGUAGE
THEY UNDERSTAND AND NOT TALK
DOWN TO THEM BUT ACTUALLY CAN
HAVE CONVERSATIONS WITH THEM.
I THINK THAT'S THE WAY YOU BUILD
TRUST.
>> OKAY, GREAT.
JEAN?
>> THANK YOU SO MUCH FOR SHARING
YOUR VISION WITH US.
WE REALLY APPRECIATE IT.
AND THERE'S SO MANY THINGS THAT
WE ARE ALIGNED ON.
ONE OF THE THINGS THAT I NEED
CLARIFICATION ON, IF YOU COULD
HELP ME UNDERSTAND, YOU TALKED
ABOUT ACADEMIC FREEDOM AND
SUPPORTING ACADEMIC FREEDOM.
AND ON THE OTHER SIDE, I'M
THINKING THERE ARE TOPICS THAT
WE'RE NOT READY TO FUND AT NIH
ANYMORE, IF I UNDERSTAND THIS
CORRECTLY.
SO I WANT CLARIFICATION ON --
FOR ME ACADEMIC FREEDOM IS, YOU
KNOW, THE ABILITY TO STUDY
WHATEVER IT IS I WANT TO STUDY,
AND HOW DOES THAT FIT TOGETHER.
AND THE SECOND THING IS MORE IN
ALIGNMENT WITH WHAT WE JUST
HEARD.
I WONDERED IF THERE WAS ANOTHER
WAY WE COULD APPROACH WHAT I
CALL SCIENCE AND SOCIETY, THAT
IT'S A DIALOGUE BETWEEN THE
GENERAL FICK PLIK AND US.
WE TALK TO EACH OTHER ALL THE
TIME, WE GET IT, WE GET EACH
OTHER, WE UNDERSTAND IT, WE'RE
IN THE SAME ECOSYSTEM TOGETHER,
BUT I THINK WHAT WE'RE NOT DOING
WELL, AND I TOTALLY AGREE, IS
REACHING THE PUBLIC WHERE THEY
ARE.
BUT IT STILL AGAIN, TO ME, THAT
COMMUNICATION CAN'T BE ONE WAY.
WE CAN'T TALK AT THEM AS YOU
SAID.
WHEN WE SPEAK WITH THEM, I THINK
WE HAVE TO BRING THEM INTO
CONVERSATION.
SO I WOULD LOVE TO SEE US STAND
UP AN OFFICE THAT'S RATHER
ROBUST IN HAVING THAT
CONVERSATION BECAUSE WE CAN'T
BUILD TRUST WITHOUT
CONVERSATION, WE CAN'T TELL THEM
WHAT WE'RE DOING AND THEY CAN'T
SAY I HATE YOU FOR THIS OR I
DON'T TRUST YOU, IT'S NOT GOING
TO WORK IN THE LONG TERM.
SO FOR A SUSTAINABLE MODEL WHERE
SCIENCE AND SOCIETY INTERACT IN
WAYS THAT YOU JUST TALKED ABOUT,
AND A PODCAST, MANY OF THOSE, IT
CAN'T JUST BE ONE ROUTE FOR US
TO UNDERSTAND THIS, BUT I'M
REALLY STRUGGLING WITH -- I
THINK WE WORK SO HARD ON BEHALF
OF THE PUBLIC AND YET THEY DON'T
KNOW IT, SO THAT'S A STRUGGLE,
THAT'S A REAL STRUGGLE, THAT'S A
SADNESS ACTUALLY, SO HOW DO WE
TRY TO ADDRESS IT TOGETHER.
>> JEAN, THANK YOU FOR THOSE
QUESTIONS.
SO FIRST ON ACADEMIC FREEDOM, I
THINK TO ME THE QUESTION OF
ACADEMIC FREEDOM ISN'T CAN I
WORK ON ANYTHING I WANT.
I MEAN, THAT IS PART OF ACADEMIC
FREEDOM, BUT IT'S DISTINCT FROM
WHAT -- THE NIH HAS LIMITED
RESOURCES, SO WHAT DOES THE NIH
INVEST IN, TO ME THE KEY
QUESTION IS, ARE WE INVESTING IN
THINGS THAT WILL MEET OUR
MISSION, ADVANCING THE HEALTH
AND LONGEVITY OF THE AMERICAN
PEOPLE, ADVANCING SCIENCE TO
ADVANCE THE LONGEVITY OF THE
AMERICAN PEOPLE.
THAT'S THE QUESTION.
SO THAT'S NOT A QUESTION OF
ACADEMIC FREEDOM, THAT'S A
QUESTION OF HOW DO WE SHEPPARD
SQUARSCARCE RESOURCES SO WE MEEE
MISSION.
BUT WITHIN THAT, THERE SHOULD BE
ACADEMIC FREEDOM.
IF SOMEBODY WRITES A PAPER THAT
HAS A SCIENTIFIC ADVANCE THAT
CONTRADICTS AN IDEA THAT I'VE
HAD, EVEN THOUGH I'M NIH
DIRECTOR, THAT PERSON SHOULD
HAVE THE ABSOLUTE RIGHT TO BE
ABLE TO PUBLISH THAT PAPER AND
TO SAY WHAT THEY BELIEVE.
THEY SHOULD BE ABLE TO
CONTRADICT ME OR ANYBODY ELSE.
SCIENCE ADVANCES WHEN PEOPLE
DISAGREE WITH EACH OTHER, HAVE
DIFFERENT CONCRETE HYPOTHESES
AND THEN YOU DO EXPERIMENTS THAT
DETERMINE ONE IS RIGHT AND
ONE'S.
AND THAT DISCUSSION REALLY IS
THE CORE AND HEART OF ACADEMIC
FREEDOM.
AS NIH DIRECTOR, OF COURSE, I
DON'T HAVE ANY CAPACITY OR ANY
DESIRE TO STOP PEOPLE FROM
SAYING OR THINKING THINGS THAT
THEY WANT TO SAY IN THE
SCIENTIFIC COMMUNITY AT LARGE.
THE POWER THAT I WILL HAVE, AND
OF COURSE IT'S LIMITED AND
ADVISED BY YOU ALL AND OTHER
FOLKS, IS WHERE DO WE PUT OUR
SCARCE RESOURCES SO THAT WE
ADVANCE THE HEALTH OF THE
AMERICAN PEOPLE?
JUST VERY -- I THINK -- SUBTEXT
TO YOUR QUESTION, THE
PRESIDENT'S ORDER ON DEI
INITIATIVES I THINK ARE ONE OF
THESE THINGS WHERE I THINK IT'S
MISUNDERSTOOD.
I DON'T THINK THAT THE -- I READ
THOSE CAREFULLY AND I DON'T
THINK THAT THEY'RE AIMED AT
STOPPING FUNDAMENTAL RESEARCH
THAT ADVANCES THE HEALTH AND
WELL-BEING OF MINORITY POP
POPULATIONS.
I WOULDN'T HAVE ACCEPTED THIS
JOB IF THAT WAS THE CASE.
I THINK THAT THE HEALTH AND
WELL-BEING OF MINORITY
POPULATIONS ARE -- AS WELL AS
EVERY AMERICAN ARE A CENTRAL
FOCUS OF THE NIH AND WILL
CONTINUE TO BE UNDER MY WATCH.
AND SO THE QUESTION ABOUT KEI IN
MY VIEW IS MORE OF A POLITICAL
ETIOLOGY.
JUST AS A POINT OF VIEW, AS
SHEPPARD OF THE NIH FUNDS, I
THINK MONEY PUT TO THAT WILL
HAVE LESS OF AN IMPACT OF THE
HEALTH AND WELL-BEING OF
AMERICANS, INCLUDING MINORITIES,
THAN MONEY PUT TO DIRECTLY
ASKING HOW CAN WE PREVENT
CHRONIC DISEASE, WHICH AFFLICTS
MINORITY AMERICANS AT HIGHER
LEVELS THAN MANY OTHERS.
SO I HOPE I ADDRESSED YOUR FIRST
QUESTION DIRECTLY.
AS FAR AS THE SECOND QUESTION,
YOU KNOW, THE MEANS OF
COMMUNICATION BETWEEN THE PUBLIC
AND SCIENTISTS, I MEAN, I THINK
IT'S JUST HARD BECAUSE WE'RE SO
USED TO TALKING TO THE PUBLIC IN
A CERTAIN WAY.
I REMEMBER WHEN I WAS A YOUNG
SCIENTIST, THE FIRST TIME
SOMEBODY APPROACHED ME AND ASKED
ME IF I'D WORK ON A PRESS
RELEASE, I THOUGHT TO MYSELF,
WHY IS THIS MY JOB, I SHOULDN'T
HAVE TO DO ANY OF THIS.
BUT I FOUND, THOUGH, IN THE LAST
FEW YEARS THAT INTERACTING
DIRECTLY WITH THE PUBLIC REALLY
DOES HELP -- IT SHARPENED MY
SCIENTIFIC IDEAS, IT HELPED
MESSY WHERE I FELL SHORT AS A
SCIENTIST IN COMMUNICATING, AND
I THINK IT'S ALTHOUGH SOMETIMES
BRUISING BECAUSE YOU HEAR THINGS
YOU DON'T WANT TO HEAR, IT'S
REALLY VITAL.
AND I DON'T KNOW, I'M GOING TO
TRY TO LEAD BY EXAMPLE ON THIS
AND JEAN, ANY SUGGESTIONS YOU
HAVE OR WORKING TOGETHER ON
THIS, I'D REALLY WELCOME.
IT ONE OF THESE THINGS THAT'S
GOING TO BE HARD BUT IS REALLY
ESSENTIAL IF WE'RE GOING TO
REGAIN THE TRUST OF THE AMERICAN
PEOPLE.
>> I'M REALLY HAPPY TO WORK ON
THIS, I THINK ABOUT IT ALL THE
TIME.
AND THE FIRST THING YOU SAID
ABOUT DEI, THANK YOU FOR SAYING
THAT.
I STILL THINK PROBABLY MASSIVE
MISUNDERSTANDING OF WHAT EXACTLY
IT MEANS AND IT DOESN'T MEAN.
>> WELL, JEAN, TO THE EXTENT
THAT -- THINGS THAT ADVANCE THE
HEALTH AND WELL-BEING OF PEOPLE,
THE NIH WILL SUPPORT IT.
THAT'S MY LITMUS LINE.
>> THANK YOU.
OKAY.
WE ARE GOING TO TAKE TWO MORE
QUESTIONS AND THEN I'M GOING TO
CUT THIS DISCUSSION TO A CLOSE
UNFORTUNATELY, ALTHOUGH I'M SURE
WE COULD ALL GO ALL DAY.
BUT I WANT TO BE RESPECTFUL OF
DR. BHATTACHARYA'S TIME AND OF
THE VERY FULL AGENDA THAT WE
HAVE FOR THE REST OF THE
AFTERNOON.
SO MONICA AND THEN LINDA,
PLEASE.
THANK YOU.
>> I THINK IT IS TREMENDOUSLY
REASSURING TO HEAR YOUR
PERSPECTIVE AS A LONG-STANDING
SCIENTIST AND AS SOMEONE WHO
CARES ABOUT THE HEALTH OF THE
AMERICAN PEOPLE.
AS AN INFECTIOUS DISEASE
RESEARCHER, IT'S HARD FOR ME NOT
TO BRING UP GLOBAL HEALTH
RESEARCH, AND THE REASON IS THAT
HIV IS A CHRONIC DISEASE.
CERTAINLY IN NO WAY DOES THE
ENTIRE BUDGET OF THE NIH GO
TOWARDS ACUTE DISEASES.
I THINK IT IS GENERALLY SKEWED
TOWARDS CHRONIC DISEASES,
INCLUDING THE CHRONIC DISEASES
IN INFECTIOUS DISEASE, WHICH ARE
HEPATITIS B AND HIV MOST
PROMINENTLY WITH AFTEREFFECTS
FROM TUBERCULOSIS.
SO DID WANT TO BRING UP YOUR
IDEAS ON GLOBAL HEALTH RESEARCH
AND THE TRANSLATION OF THAT WORK
THAT'S DONE IN PROMINENT PLACES
LIKE SOUTH AFRICA, WHICH
ABSOLUTELY HAS THE HIGHEST HIV
BURDEN, TO THE HEALTH OF
AMERICANS.
MOST OF THE WORK THAT IS LED TO
TREATMENT PARADIGMS TO
PREVENTION PARADIGMS, SCREEN FOR
RESISTANCE HAS BEEN DONE IN
GLOBAL SETTINGS, BUT ABSOLUTELY
BENEFITS AMERICANS BECAUSE
THAT'S HOW I KNOW HOW TO TREAT
HIV IS BECAUSE OF A BIG STUDY
DOWN IN SOUTH AFRICA.
SO WANTED TO ASK ABOUT -- AND
CERTAINLY THAT APPLIES TO AIR
POLLUTION TO CLASHES, TO
VIOLENCE, TO SO MANY OTHER
THAINGS MAY BE MORE HIGH
PREVALENCE IN A CERTAIN REGION
BUT BENEFIT AMERICANS.
SO THAT WAS MY QUESTION.
>> SO THANK YOU, MONICA, FOR
THAT.
I THINK THE PORTFOLIO -- THE NIH
HAS A LONG-STANDING RECORD OF
SUCCESS IN COLLABORATING IN
RESEARCH WITH OTHER COUNTRIES.
AND I THINK IT SHOULD CONTINUE
TO HAVE THAT.
THAT SAID, THERE ARE -- IT'S
INCUMBENT ON US TO ENSURE THAT
THAT PORTFOLIO REALLY DOES
TRANSLATE AND BENEFIT THE HEALTH
AND WELL-BEING OF THE AMERICAN
PEOPLE, WHICH IS OF COURSE THE
MISSION.
AND I THINK SPECIFICALLY FOR
HIV, THERE'S BEEN RECENT
ADVANCES WHICH I THINK OPEN UP,
FOR INSTANCE --CAPAVIR, YOU CAN
PREVENT HIV FOR ALMOST UP TO A
YEAR, I THINK.
REMARKABLE PRODUCT.
THAT OPENS UP NEW AREAS OF
POTENTIALLY THINKING ABOUT HOW
DO WE ERADICATE HIV FROM THIS
COUNTRY.
SO LOOKING AT THE PORTFOLIO OF
HIV INVESTMENTS, WE ALWAYS WANT
TO MAKE SURE WE ARE USING OUR
DOLLARS FOR THE MOST IMPORTANT
THINGS.
I'M NOT -- AND I'M AWARE AS
YOU'VE TOLD ME MANY TIMES,
MONICA, ABOUT THE IMPORTANCE OF
THE TRIAL NETWORKS IN SOUTH
AFRICA, FOR INSTANCE.
>> SORRY.
>> I APPRECIATE YOUR ADVICE ON
THAT ON ALL FRONTS.
BUT I DO THINK THAT LOOKING
CAREFULLY AT THIS PORTFOLIO IS
SOMETHING I INTEND TO DO, BUT
THE KEY TOUCH STONE WILL BE
LET'S MAKE INVESTMENTS THAT
ADVANCE THE HEALTH OF THE
AMERICAN PEOPLE, AND I
ANTICIPATE THAT THERE WILL BE
SOME CHANGES BUT I DON'T KNOW --
I'M NOT -- I DON'T HAVE ANY
INTENTION TO STOP WORKING IN
FOREIGN COUNTRIES.
I THINK THAT WOULD ACTUALLY HARM
THE HEALTH AND WELL-BEING OF THE
AMERICAN PEOPLE.
SO I THINK WE CAN WORK TOGETHER
GOING FORWARD.
>> THANK YOU SO MUCH.
THANK YOU.
>> LINDA?
>> I'M LINDA CHANG.
I JUST HAVE A VERY -- THANK YOU
FIRST OF ALL FOR THAT WONDERFUL
OVERVIEW OF YOUR VISION OF NIH
AND I REALLY AGREE WITH ALL OF
YOUR POINTS.
I JUST DIDN'T HEAR A DISCUSSION
ABOUT WHETHER YOU HAVE PLANS ON
THE -- WE'VE BEEN HEARING ABOUT
THE NIH INSTITUTES ARE GOING TO
BE REORGANIZED AND WHETHER YOU
HAVE ANY SPECIFIC PLANS ALREADY
FOR THAT.
I'M JUST CURIOUS ABOUT THAT.
JUST A QUICK QUESTION.
>> THANK YOU, LINDA.
I DON'T HAVE ANY SPECIFIC PLANS
FOR REORGANIZATION AT THE
MOMENT.
I'VE TALKED WITH MEMBERS OF
CONGRESS WHO HAVE PLANS.
I THINK THE OMB HAD A PLAN, I'VE
ALSO READ ALL THE DOCUMENTS
GOING BACK DECADES ON
REORGANIZATION IDEAS FOR THE
NIH.
I'M GOING TO WORK WITH THE
ADMINISTRATION AND WITH CONGRESS
ON THIS.
I'M NOT PLANNING TO GO ROGUE ON
IT MYSELF.
I THINK ANY REORGANIZATION IS
GOING TO HAVE TO THINK THROUGH
CAREFULLY WHAT WILL BE GAINED
FROM IT.
IF IT'S JUST REORGANIZATION FOR
ITS OWN SAKE, IT WON'T MAKE ANY
SENSE, BUT IF IT REALLY DOES
RESULT IN COLLABORATIONS THAT
WOULD NOT HAVE OCCURRED,
REDUCTIONS IN DUPLICATION OF
EFFORTS THAT DON'T ACTUALLY --
THINGS LIKE THAT, THEN IT MIGHT
MAKE SENSE TO DO IT.
BUT I'M GOING TO RELY VERY
HEAVILY ON ADVICE.
THERE'S AN SMRB PROCESS THAT
CONGRESS ACTUALLY PUT IN PLACE
FOR THIS EXACT PROCESS.
SO I'M THINKING ABOUT MAYBE
USING THAT IF THERE REALLY IS A
LOT OF DESIRE IN CONGRESS TO DO
THIS REORGANIZATION.
I'M NOT PLANNING ON DOING
ANYTHING HALF BAKED ON THIS.
>> SO YOU DON'T SEE THIS
HAPPENING IN THE VERY NEAR
FUTURE?
BECAUSE THERE WERE RUMORS THAT
THEY WERE GOING TO DECREASE THE
NUMBER OF INSTITUTES DOWN TO
EIGHT INSTITUTES OR SOMETHING
LIKE THAT, SOMETHING DRASTIC.
>> I THINK THERE WAS A LEAK OF
THE OMB MEMO.
>> YEAH.
>> BUT AGAIN, LIN DA THAT WAS
THE BEGINNING OF A NEGOTIATION.
I DON'T KNOW.
WE'LL SEE WHAT THE END POINT IS.
I PERSONALLY HAVE NO PLANS TO DO
ANYTHING WITHOUT LOTS OF ADVICE.
>> OKAY.
THANK YOU.
>> OKAY, GREAT.
THANK YOU ALL FOR SUCH A ROBUST
DISCUSSION AND THANK YOU SO
MUCH, JAY, FOR YOUR REMARKS,
BOTH YOUR PRESENTATION AND YOUR
THOUGHTFUL CONSIDERATION OF THE
QUESTIONS POSED TO YOU BY
COUNCILMEMBERS AND FOR SPENDING
SOME EXTRA TIME WITH US.
I KNOW YOU HAVE A VERY BUSY
SCHEDULE, SO THANK YOU FOR THAT.
OKAY.
>> THANK YOU.
>> WE ARE NOW GOING TO MOVE ON
TO THE NEXT PRESENTATION, WHICH
IS FROM MARINA VOLKOV ON THE
COUNCIL OF COUNCILS' WORKING
GROUP ON SCIENCE OF SCIENCE.
SHE IS THE DIRECTOR OF DPCPSI'S
OFFICE OF EVALUATION,
PERFORMANCE AND REPORTING.
SO NIH HAS A LONG HISTORY OF
ENGAGING WITH RESEARCHERS TO
GENERATE EVIDENCE TO INFORM
IMPROVEMENTS TO ITS PROGRAMS,
POLICIES AND PROCESSES.
THE SCIENCE OF SCIENCE ALSO
KNOWN AS META SCIENCE IS
ABSOLUTELY CRUCIAL FOR
UNDERSTANDING THESE PROCESSES
AND THAT SHAPE SCIENTIFIC
DISCOVERY AND A INNOVATION.
SO BY ANALYZING PATTERNS AND
FUNDING COLLABORATION,
PUBLICATION AND REPRODUCIBILITY,
THIS FIELD CAN REALLY HELP
OPTIMIZE RESEARCH PRACTICES AND
IMPROVE RESOURCE ALLOCATION,
PARTICULARLY IN A CONSTRAINED
ENVIRONMENT, AND ENHANCE OUR
SCIENTIFIC IMPACT OVERALL.
ULTIMATELY IT THIS REALLY
STRENGTHENING -- APPLYING
SCIENTIFIC PRINCIPLES TO HELP US
UNDERSTAND HOW TO BETTER SUPPORT
AND SHAPE SCIENCE IS REALLY A
CRUCIAL ROLE FOR DPCPSI.
SO WE RECENTLY SOLICITED
APPLICATIONS FOR A PILOT SCIENCE
OF SCIENCE SCHOLARS PROGRAM THAT
WILL BRING EXPERTS IN THE
SCIENCE OF SCIENCE TO HELP
ANSWER CRITICALLY IMPORTANT
QUESTIONS TO IMPROVE NIH
PROCESSES, POLICIES AND
PROGRAMS, BUT THERE IS MORE THAT
WE CAN DO.
WE THINK THIS DESERVES FURTHER
BROAD CONSIDERATION, SO THAT'S
BUILT INTO A PROPOSAL WE HAVE
AND THAT I WOULD APPRECIATE YOUR
FEEDBACK ON.
SO MARINA, I'LL TURN IT OVER TO
YOU NOW.
>> NICOLE, THANK YOU VERY MUCH.
AND I APPRECIATE THAT
INTRODUCTION.
IT'S ACTUALLY -- THAT WAS GREAT
COVERAGE AND I'M GOING TO SEE IF
I CAN MAKE UP SOME SIGNIFICANT
TIME FOR YOU ALL BECAUSE NICOLE
REALLY LAID OUT WHAT IT IS THAT
I'M HERE TO DISCUSS, SO I CAN
SKIP THROUGH.
SO WITH THAT, IF WE CAN GO TO
THE NEXT SLIDE, PLEASE.
AS NICOLE MENTIONED, THERE IS
THIS VERY ROBUST
INTERDISCIPLINARY FIELD OF THE
SCIENCE OF SCIENCE OR META
SCIENCE.
ALSO WHERE PEOPLE TRULY ARE
STUDYING THE SCIENTIFIC PROCESS
ITSELF, AND WHAT I'M HERE TO
TALK ABOUT TODAY SL HOW WE CAN
BRING THAT KIND OF ROBUST
SCIENTIFIC INQUIRY IN TO NIH TO
ANSWER MANY OF THE QUESTIONS OR
TO BEGIN TO ANSWER MANY OF THE
QUESTIONS THAT HAVE BEEN
DISCUSSED THROUGHOUT THE DAY
TODAY.
AND I FEEL AS THOUGH THE WHOLE
CONVERSATION THAT WE HAD THIS
MORNING, WITH DR. BHATTACHARYA
JUST NOW, REALLY BEGS THE
QUESTION OF HOW CAN NIH BETTER
UNDERSTAND HOW THE THAINGS WE DO
ARE MEETING OUR MISSION AND HOW
CAN WE IMPROVE UPON THAT.
SO THAT'S REALLY THE CRUX OF
WHAT WE'RE TALKING ABOUT.
AND AGAIN, I'M NOT GOING TO GO
THROUGH THIS BECAUSE I THINK
THIS IS REALLY WHAT WE'VE BEEN
DISCUSSING THROUGHOUT MUCH OF
THE DAY.
I WANT TO POINT OUT THIS IS A
QUESTION NIH HAS BEEN GRAPPLING
WITH FOR SOME TIME.
BACK IN 2014, THE SCIENTIFIC
MANAGEMENT REVIEW BOARD, THE
SMRB PUBLISHED A REPORT IN WHICH
IT RECOMMENDED THAT NIH HAVE A
SYSTEMATIC AND COMPREHENSIVE
APPROACH TOWARDS STUDYING
ITSELF.
WE HAVE BEEN WORKING STEADILY ON
THIS SYSTEMATIC AND
COMPREHENSIVE APPROACH, AND IF I
CAN GO TO THE NEXT, MANY
EXTERNAL FOLKS HAVE BEEN SAYING
THE SAME THING.
ONE THING THAT IS OF GREAT
IMPORTANCE, SO IN THE SCIENCE OF
SCIENCE FIELD, BY BRINGING
EXTERNAL PEOPLE IN TO HELP US
BETTER ANSWER THESE QUESTIONS,
ONE DID CONNECT THAT HAS ALWAYS
EXISTED BETWEEN THE PEOPLE IN
THE EXTERNAL WORLD AND THOSE OF
US WORKING WITHIN IS THERE'S
ALWAYS BEEN A BIT O IN TERMS OF
THE QUESTIONS OF PEOPLE EXTERNAL
TO US VOARS US THOSE INTERNAL,
AND HE QUESTIONS OF -- NIH IS A
VERY BYZANTINE PLACE, WE HAVE
DATA, WE DID NOT MAKE IT
AVAILABLE TO EVERYONE BECAUSE IT
IS ALSO PROPRIETARY DATA.
EARLIER TODAY, WHEN TALKING
ABOUT HRHR, THE QUESTION CAME UP
OF LOOKING AT THOSE -- OF THOSE
UNFUNDED APPLICATIONS.
THAT IS JUST ONE EXAMPLE OF
PROPRIETARY DATA THAT WE CANNOT
SHARE OUTSIDE OF THE NIH
FIREWALL, WHICH HAS ALWAYS BEEN
A FRUSTRATION TO THE PEOPLE WHO
ACTUALLY STUDY US.
ACTUALLY IF WE CAN GO TO THE
NEXT SLIDE, I'M GOING TO SKIP
OVER SOME OF THESE FACTORS.
SO AGAIN, MANY, MANY RESEARCHERS
HAVE BEEN STUDYING US FROM
OUTSIDE OF NIH AND WANT TO POINT
OUT IN THE MIDDLE OF THIS, THIS
IS JUST A HANDFUL OF EXAMPLES OF
IMPORTANT STUDIES.
YOU'LL SEE DR. BHATTACHARYA, HE
REFERENCED THIS STUDY THAT HE
PUBLISHED ON DOES NIH FUND EDGE
SCIENCE, SO HE HAS BEEN WORKING
IN THE SCIENCE OF SCIENCE AREA.
I ALSO WANT TO POINT OUT TO THE
LEFT, THE RACE/ETHNICITY AND NIH
RESEARCH AWARDS IS A PAPER THAT
CAME OUT IN 2011 BY DONNA
GINTHER AND COLLEAGUES AND I
JUST WANT TO MENTION THIS PAPER
IN PARTICULAR BECAUSE FOLKS HAVE
BEEN REFERRING TO THIS FOR YEARS
AND YEARS AT NIH AS THE GINTHER
EFFECT.
IT HAD REAL IMPACT IN HOW NIH
APPROACHED SUPPORT OF THE
RESEARCH COMMUNITY AND WE NEED
MORE WORK SUCH AS THE GINTHER
PAPER TO REALLY HELP US
UNDERSTAND WHAT WE'RE DOING HOW
WE CAN DO IT BETTER.
SO WITH THAT NEXT SLIDE.
SO THIS SCIENTIFIC FIELD, THE
SCIENCE OF SCIENCE FIELD IS
PRIMARILY FUNDED THROUGH -- FOR
PUBLIC FUNDS THROUGH THE
NATIONAL SCIENCE FOUNDATION.
BACK IN 2006, THEY BEGAN A
PROGRAM KNOWN AS THE SCIENCE OF
SCIENCE AND INNOVATION POLICY,
SCISIP.
THE NAME HAS CHANGED BUT THE
POINT REMAINS THE SAME, WHAT
EVIDENCE CAN BE GENERATED BY THE
SCIENTIFIC FIELD THAT CAN HELP
POLICYMAKERS IN IMPROVING UPON
WHAT WE DO.
SO THIS WHOLE IDEA OF THIS
PROGRAM WAS TO REALLY CREATE AN
EVIDENCE-BASE FOR POLICYMAKERS
IN MAKING DECISIONS ON HOW BEST
TO CONDUCT SCIENTIFIC RESEARCH.
SO BACK IN 2019, OUR NATIONAL
INSTITUTE OF GENERAL MEDICAL
SCIENCES PARTNERED WITH THIS
PROGRAM TO CREATE A SUBSET OF
THE PROGRAM AND TO REALLY
SUPPORT THOSE STUDIES THAT COULD
EXAMINE IMPORTANT ASPECTS OF THE
BIOMEDICAL RESEARCH ENTERPRISE.
SO SCIENCE OF SCIENCE BIO HAS
EXISTED SINCE 2019.
IT'S AN INTERESTING PROGRAM
BECAUSE IT IS TRULY CONDUCTED IN
PARTNERSHIP WITH NSF AND THE
REVIEW, THE MANAGEMENT OF THE --
THE REVIEW ASPECTS, THAT IS
HANDLED BY NSF AND THEN THE
FUNDING IS DONE BY N IGMS AND
THE MANAGEMENT OF THE GRANTS
MOVING FORWARD.
I WANTED TO GIVE YOU JUST A
HANDFUL OF EXAMPLES WITH THE
NEXT SLIDE, PLEASE.
AGAIN THESE ARE JUST A FEW
EXAMPLES OF THINGS THAT ARE
BEING STUDIED WITHIN THAT.
YOU CAN SEE THAT THESE GRANTS
CAN LOOK OR THESE GRANT PROJECTS
WILL LOOK AT THE IMPACT OF NIH
POLICIES ON THE CONDUCT OF
SCIENCE.
THERE ARE GRANTS TO LOOK AT THE
SUPPORT FOR RESOURCES AND
METHODOLOGY DEVELOPMENT, WHAT IS
THE IMPACT OF THOSE PROGRAMS.
THERE ARE STUDIES TO LOOK AT THE
WORKFORCE AND HOW WE SUPPORT THE
WORKFORCE, WHAT IS THE BEST WAY
OF GOING ABOUT MAINTAINING THE
PIPELINE OF RESEARCHERS, AND
THERE ARE STUDIES ON DATA
SHARING AND THE IMPACT OF DATA
SHARING AND WHAT IT MEANS FOR
SCIENCE.
THIS IS JUST EXAMPLES OF THE
TYPE OF PROJECTS THAT ARE FUNDED
WITHIN THIS.
IN ADDITION TO THIS GRANT
PROGRAM, IF WE CAN GO TO THE
NEXT SLIDE, PLEASE, WE HAVE MANY
DIFFERENT WAYS IN WHICH WE HAVE
BEEN ENGAGING WITH THE SCIENCE
OF SCIENCE RESEARCH COMMUNITY.
WE'VE HAD SEVERAL MEETINGS, THIS
IS JUST LISTING A HANDFUL OF
THEM, WHERE WE TRY TO BRING
TOGETHER AGAIN THE NIH
POLICYMAKERS, THE NIH PROGRAM
FOLKS TO WORK CLOSELY WITH THIS
RESEARCH COMMUNITY TO HELP
CREATE THAT HANDSHAKE WHERE THE
QUESTIONS OF INTEREST ALIGN TO
IDENTIFY THOSE, AND ALONG THOSE
LINES, WE PARTICIPATED LAST YEAR
IN SOMETHING WITH OMB.
OMB, AND I DIDN'T GO INTO IT
THERE, THE EVIDENCE ACT OF THE
FOUNDATIONS OF EVIDENCE-BASED
POLICYMAKING ACT KNOWN AS THE
EVIDENCE ACT WAS PASSED IF 2018,
AS PART OF THE IMPLEMENTATION OF
THAT ACT, OMB IS TRYING TO
CREATE OPPORTUNITIES FOR
HANDSHAKES BETWEEN FEDERAL
DEPARTMENTS AND THE RESEARCH
COMMUNITY AND WE PARTICIPATED IN
THAT WHERE WE WERE ABLE TO
PUBLISH ON THE OMB PORTAL WHAT
ARE THE QUESTIONS OF GREATEST
INTEREST TO NIH THAT WE WOULD
HOPE THAT THOSE EXTERNAL TO US
WOULD STUDY ABOUT US, AND THAT
GENERATED A LOT OF INTEREST, A
LOT OF INTERESTING CONVERSATIONS
AND HOPEFULLY AT SOME POINT A
LOT OF VERY INTERESTING RESEARCH
RESULTS THAT NIH CAN THEN
IMPLEMENT.
AND THEN NICOLE MENTIONED OUR
SCIENCE OF SCIENCE SCHOLARS
PROGRAM.
RIGHT NOW WE ARE WORKING ON A
PILOT OF THAT WHERE THIS IS DONE
IN COLLABORATION WITH OUR OFFICE
OF EXTRAMURAL RESEARCH, WHERE WE
PLAN TO BRING IN SCIENCE OF
SCIENCE SCHOLARS.
THERE'S NO MONEY INVOLVED, THEY
WILL BE SPECIAL VOLUNTEERS BUT
THEY WILL BE WORKING VERY
CLOSELY, NOT ONLY WILL THEY HAVE
ACCESS BEHIND THE FIREWALL TO
ALL OF NIH'S PROPRIETARY DATA,
BUT THEY WILL BE WORKING VERY
CLOSELY WITH THOSE PEOPLE WHO
UNDERSTAND THIS DATA THE BEST.
AS I MENTIONED, DATE TA CAN BE
RATHER BYZANTINE AT TIMES
GETTING THROUGH THAT, BUT BY
WORKING TOGETHER, IN
PARTNERSHIP, WE'RE REALLY HOPING
THAT THIS IS A UNIQUE
OPPORTUNITY FOR US TO LEARN FROM
THE FIELD SOME OF THE
METHODOLOGY THAT THEY WOULD
APPLY TOWARD EXAMINING THAT
DATA.
FOR THOSE WORKING IN THE FIELD
TO ACTUALLY GET THEIR HANDS ON
MUCH OF THE DATA THAT THEY ARE
HOPING TO GET ON.
AND THERE ARE MANY OTHER
EXAMPLES THAT WE CAN TALK ABOUT,
HOW WE'RE TRYING TO ENGAGE WITH
THE SCIENCE OF SCIENCE
RESEARCHERS.
I'M TALKING REALLY FAST BECAUSE
I AM TRYING TO GET US CAUGHT UP
A LITTLE BIT ON TIME AS MUCH AS
POSSIBLE.
I WANTED TO END WITH WHAT I
THINK IS A REALLY FASCINATING
EXAMPLE.
WE HAVE BEEN TALKING THROUGHOUT
THE DAY ABOUT METRICS, AND OUR
FOLKS AT THE NATIONAL EYE
INSTITUTE IN COLLABORATION WITH
SEVERAL OTHER INSTITUTES,
CENTERS AND OFFICES HAVE
LAUNCHED A CHALLENGE TO TRY AND
CREATE AN INDEX THAT COULD
REALLY MEASURE TO SOME DEGREE
EXEMPLARY DATA SHARING EXAMPLES.
OR HOW EFFECTIVE IS A RESEARCHER
IN SHARING THEIR DATA?
IS THERE A WAY THAT WE CAN BEGIN
TO CAPTURE THE EFFECTIVENESS OF
DATA SHARING.
SO AS I SAID, JUST WANTED TO END
WITH WHAT I THOUGHT WAS AN
INTERESTING EXAMPLE.
THEN IF WE GO TO THE NEXT SLIDE,
SO WHAT IS NEXT, A SYSTEMATIC
AND COMPREHENSIVE WAY BY WHICH
NIH CAN CONTINUALLY STRENGTHEN
ITS ABILITY TO STUDY ITSELF AND
HOW DO WE ENGAGE WITH THE
EXTERNAL SCIENCE OF SCIENCE
COMMUNITY TO HELP US DO JUST
THAT.
WE BELIEVE THESE QUESTIONS AND
MORE COULD BE ANSWERED BY A
COUNCIL OF COUNCIL WORKING
GROUP.
I WANT TO POINT OUT THAT WE'RE
NOT LOOKING FOR THE WORKING
GROUP TO COME UP WITH ALL THE
NEW METRICS AND INDEXES AND ET
CETERA THAT WE NEED, BUT RATHER
TO HELP US TO REALLY THINK
THROUGH BEST WAYS OF ENGAGING
WITH THE FIELD, BUT ALSO TO
THINK THROUGH BEST WAYS FOR US
TO APPROACH IT.
HOW CAN WE BE MORE SYSTEMATIC
AND COMPREHENSIVE IN OUR
APPROACH TOWARDS STUDYING
OURSELVES.
WITH THAT, I'M GOING TO OPEN IT
UP FOR QUESTIONS, COMMENTS, AND
I APOLOGIZE IF I WENT REALLY
FAST, BUT AS I SAID, I THINK WE
TALKED AN AWFUL LOT EARLIER
TODAY ABOUT SOME OF THESE IDEAS.
>> THANKS, MARINA.
I REALLY APPRECIATE YOUR
DEDICATION TO GETTING US BACK ON
TIME AS WELL.
SO IF COUNCILMEMBERS HAVE ANY
QUESTIONS OR COMMENTS, PLEASE
RAISE YOUR HAND, AND I WILL CALL
ON YOU AND ASK YOU TO UNMUTE
YOURSELF.
KEVIN, PLEASE GO AHEAD.
>> HI, THANKS A LOT.
MARINA, NICE TO MEET YOU ALSO.
I'M KEVIN JOHNSON FROM PENN.
I'M CURIOUS, THERE WAS A TIME
WHEN COUNCIL AND THE NIH WERE
THINKING ABOUT SCIENCE
COMMUNICATION AS A MORE
ORGANIZED ACTIVITY, ESPECIALLY
THE TEACHING OF SCIENCE
COMMUNICATION.
DO YOU SEE ANY SYNERGIES BETWEEN
THAT IDEA, RECOGNIZING YOU MAY
NOT HAVE EVER SEEN THAT CONCEPT,
AND WHAT WE'RE TRYING TO DO WITH
THE SCIENCE OF SCIENCE?
>> WELL, THANK YOU FOR THAT
QUESTION, AND I'LL ADMIT I'VE
BEEN AROUND NIH FOR QUITE SOME
TIME AND WE ACTUALLY HAD A GRANT
PROGRAM ON SCIENCE COMMUNICATION
AT ONE POINT.
AND I ACTUALLY -- I THINK THAT
SCIENCE COMMUNICATION, SO MUCH
OF WHAT EVEN DR. BHATTACHARYA
AND YOU ALL WERE SPEAKING ABOUT
BEFOREHAND, THE PUBLIC, WHEN
THEY ASK NIH WHAT ARE WE GETTING
FOR OUR INVESTMENT IN NIH, WE
NEED TO BE ABLE TO TELL THEM
SOMETHING OTHER THAN, HEY, WE
HAD A LOT OF REALLY GOOD
PUBLICATIONS IN SCIENCE.
AND HOW CAN WE BY BETTER
ASSESSING AND EVALUATING
OURSELVES, HOW DO WE GENERATE
EVIDENCE THAT WILL ALSO TELL THE
PUBLIC, THIS IS WHAT YOU'RE
GETTING?
AND IT'S A VERY, VERY TRICKY
STORY TO TELL, BECAUSE NIH
PRODUCES THE EVIDENCE BASE THAT
OTHERS THEN USE TO IMPROVE
HEALTH.
AND HOW DO WE TELL PEOPLE HOW
THIS HAPPENS, HOW DO WE TELL
PEOPLE ABOUT HOW SCIENCE IS
IMPLEMENTED, HOW DO WE KNOW WHAT
NIH RESEARCH IS DIRECTLY LED TO
SOMETHING THAT DIRECTLY BENEFITS
THE PUBLIC.
SO I THINK THAT SCIENCE
COMMUNICATION, HOW TO
COMMUNICATE WITH THE PUBLIC
BETTER, IS OF VITAL IMPORTANCE
TO THIS EFFORT.
>> THANK YOU.
>> THANKS.
JEAN, PLEASE GO AHEAD.
SORRY, RHONDA.
SORRY.
MY FAULT.
PLEASE GO AHEAD.
>> NO PROBLEM, NO PROBLEM.
SO THANK YOU SO MUCH.
SO I HAVE A COUPLE QUESTIONS ON
THIS.
PRIMARILY FROM THE STANDPOINT OF
VIEW IF I'M WONDERING WHETHER OR
NOT THERE IS A SECTOR OF SCIENCE
THAT MAY NOT NECESSARILY BE PART
OF WHAT ONE WOULD TYPICALLY
FOCUS ON.
AND LET ME CLARIFY.
I KIND OF HINTED THAT IN SEVERAL
OF MY QUESTIONS TODAY.
THIS PARTICULARLY IS IMPORTANT
IN TERMS OF LINKING SCIENCE TO
APPLICATION IN THE REAL WORLD
AND THE DELIVERY SYSTEM.
CERTAINLY WE DON'T WANT TO KEEP
THE 17 YEARS IT TAKES FROM A
SCIENTIFIC FACT TO ACTUALLY
BEING ADOPTED IN PRACTICE, SO WE
NEED TO ESCALATE AND MOVE THAT
QUICKER.
SO ONE OF THE THINGS I WOULD
WONDER IS WHETHER THAT IN THE
SCIENCE OF SCIENCE, WOULD THERE
BE AREAS WHERE YOU WOULD LOOK AT
WHAT THE OUTSIDE WORLD NEEDS
FROM THE STANDPOINT OF VIEW OF
CARE DELIVERY?
THERE ARE MANY GAPS OUT THERE,
I'LL SAY MY COLLEAGUES ARE NOT
VERY GOOD AT COMMUNICATING THOSE
AND PROBABLY NEED TO DO THAT.
BUT TO HELP THE RESEARCH AREA TO
UNDERSTAND WHERE THE PAIN POINTS
ARE.
BUT ALSO YOU AS THE RESEARCH
AREA CONNECT WITH THOSE AREAS
THAT CREATE GUIDELINES,
CONSENSUS DOCUMENTS, AND THE NEW
TERM NOW IS PLAYBOOKS THAT
ACTUALLY DEMONSTRATE HOWL TO
OPERATIONALIZE SOME NEW SCIENCE
AND SOME WAY TO HELP BRING THE
RELIABILITY OF IMPLEMENTING IT
WITH EFFECTIVENESS.
SO MY THING IS, THERE'S ANOTHER
AREA THAT NEEDS TO BE THOUGHT.
NUMBER TWO, WE NEED TO GO BEYOND
WHAT NIH CAN DO, NIH NEEDS TO
JOIN HANDS WITH THE CONSENSUS
ORGANIZATIONS, AS WELL AS THE
FUNDING ORGANIZATION THAT KIND
OF FUND NON-RESEARCH HFN BASED
NEW INFRASTRUCTURES AND
FUNCTIONS WITHIN THE HEALTHCARE
DELIVERY SYSTEM.
I HOPE THAT WASN'T TOO
CONFUSING.
>> OH, NO, NO, NO, AND I WANT TO
TELL YOU THAT I AGREE AND HAVE
RESONATED THROUGHOUT THE DAY
WITH POINTS YOU CONTINUALLY
MAKE.
AGAIN, NIH ONLY CAN ACHIEVE ITS
MISSION IF OTHERS TAKE THE
RESEARCH THAT NIH PR PRODUCES AD
ACTUALLY APPLY IT.
TO UNDERSTAND THAT HANDOFF, TO
UNDERSTAND THE CHAIN OF
EVIDENCE, THE EVIDENCE FLOW THAT
GOES FROM RESEARCH INTO
PRACTICE, ULTIMATELY INTO
IMPROVEMENTS IN HEALTH AND THEN
THE SPILLOVER EFFECTS, THAT'S
THE NUMBER ONE QUESTION, I
THINK, THAT THIS EFFORT HAS TO
REALLY START TO LOOK AT
DIFFERENT WAYS OF BUILDING THAT
CHAIN OF EVIDENCE AND
UNDERSTANDING AND FINDING THE
MARKERS OF WHEN IT ACTUALLY DOES
HAPPEN.
I WILL SAY ONE THING WE HAVE
TALKED EXTENSIVELY WITH, EVEN
WITHIN OUR OWN DEPARTMENT, IN
ORDER FOR NIH, RESEARCH TO HAVE
ANY IMPACT, IT NEEDS TO TOUCH
OTHER PARTS OF OUR OWN
DEPARTMENT.
WHETHER IT BE FDA OR CMS, ET
CETERA.
HOW DO WE BEGIN TO KNOW, HOW DO
WE BEGIN TO CAPTURE THAT
EVIDENCE FLOW OF NIH WITH OTHER
PARTS OF ITS SISTER
ORGANIZATIONS WITHIN THE
DEPARTMENT, NOT EVEN GOING TO
THE OUTSIDE, TO THE
PRACTITIONERS, BUT EVEN TO BEGIN
BY UNDERSTANDING EVIDENCE FLOW
WITHIN THE DEPARTMENT.
IF YOU LOOK AT THE SMRB REPORT
ON THE VALUE OF BIOMEDICAL
RESEARCH, IT IS ALL ABOUT HOW TO
MAKE THAT -- HOW WE CAN
STRENGTHEN OUR ABILITY TO
CAPTURE THAT CHAIN OF EVIDENCE
AS IT FLOWS FROM RESEARCH INTO
ACTUAL CHANGES IN HEALTH.
I HOPE THAT ADDRESSES --
>> YES, IT DOES, AND I HOPE THAT
PART OF THE SCOPE OF WORK THAT
THIS UNIT WILL DO WILL BEGIN TO
LOOK AT HOW TO MAP THAT OUT AND
CREATE THOSE RELATIONSHIPS THAT
ALLOWS THAT TO HAPPEN.
AND CERTAINLY WE'D BE VERY
INTERESTED IN THAT.
I'M GOING OFF COUNCIL BUT VERY
INTERESTED IN THAT BEING
FURTHERED ALONG.
>> I HOPE THAT WE CAN CONTINUE
TO ASK FOR YOUR INPUT ON THESE
THINGS.
>> OKAY, GREAT.
AND JEAN, PLEASE GO AHEAD.
>> THANKS FOR BRINGING BACK THE
GINTHER EFFECT.
I HAVE TO SAY I STILL THINK
ABOUT IT AND I WAS SO GRATEFUL
FOR THAT STUDY.
WE ALL HAD STORIES TO TELL, AND
FINALLY SHE SORT OF BROUGHT THE
DATA TOGETHER TO SEE THAT THERE
WAS DATA TO SUPPORT WHAT WE
THOUGHT WAS HAPPENING ANYWAY.
SO I AGREE, I STILL TALK ABOUT
THAT STUDY AND IT'S OVER A
DECADE OLD, I THINK, BY NOW.
BUT WHAT I WANTED TO BRING TO
THIS IS, AS WE TALK ABOUT
COMMUNICATION, I THINK THE
GENERAL PUBLIC UNDERSTANDS
STORIES, THEY UNDERSTAND
NARRATIVES.
THEY MAY NOT UNDERSTAND A
PARTICULAR CHANNEL AND HOW I
COULD BLOCK THAT CHANNEL OR
WHATEVER IT IS I COULD DO, BUT
IT UNDERSTANDS IF A DRUG WORKS
FOR A CERTAIN PERSON IN A
CLINICAL TRIAL.
WE HAVE TO PUT MORE OF THOSE OUT
THERE, THOSE STORIES FROM PEOPLE
IN THEIR COMMUNITIES, IN THEIR
NEIGHBORHOOD WHO JUST SAID LOOK,
IT WAS ON THIS CLINICAL TRIAL,
THIS DRUG HELPED MY SON, IT
HELPED ME.
I THINK WE WANT TO BRING
PERSONALIZED STORIES TO THIS.
I THINK WHEN SCIENTIST DOES IT,
WE'RE TALKING ABOUT THE
INCLUSIVE DATA OF EVERYTHING WE
STUDIED, THE GRAPHS, THE
STATISTICS.
WE MAY LOSE THEM, I DON'T SAY WE
ALWAYS DO BUT WE CAN, BUT I
THINK A STORY DOESN'T LOSE
SOMEONE.
AND I THINK WE HAVE TO BE BETTER
AT TELLING STORIES.
AND I AGREE, SOME SCIENTISTS
WEARENOT GOOD AT IT.
THEY'RE INTROVERTS, THEY WANT TO
BE IN THEIR LABS, I DON'T THINK
THEY'RE THE ONES WE NECESSARILY
NEED TO EXPLAIN THE SCIENCE.
WE HAVE TO HAVE PEOPLE WHO
COMMUNICATE SCIENCE TO OTHERS IN
SOCIETY IN A WAY THAT MAKES
SENSE.
IT DOESN'T HAVE TO BE THE
RESEARCHER THEMSELVES.
IT CAN BE IF THAT'S THEIR
PROCLIVITY AND THEY'RE GOOD AT
IT.
IT DOESN'T HAVE TO BE.
I THINK SOMETIMES WE MISS THE
POINT BY HAVING A SCIENTIST TRY
TO EXPLAIN IT IN LANGUAGE THAT
THEY'RE NOT USED TO USING, AND
THEY'RE NOT COMFORTABLE WITH.
I THINK WE NEED TO FIND WAYS TO
ACTUALLY HAVE INTERPRETERS OF
SCIENCE WHO COULD TALK TO
SOCIETY AND TALK TO PEOPLE AT
WHATEVER LEVEL THEY'RE AT TO
MAKE SURE STORIES GET THROUGH TO
THEM.
BUT I THINK IF SOMEBODY SAID I
WAS CURED CH THIS ILLNESS OR
THIS THING HAPPENED TO ME OR MY
SON IS BETTER BECAUSE OF THIS,
HE WAS ON THE AUTISM SPECTRUM,
THIS IS WHAT HAPPENED, WE HAVE
TO COMMUNICATE STORIES IF WE
WANT TO REACH EVERYONE.
EVERYONE GETS A STORY.
>> AGREED.
AND WE NEED TO BE ABLE TO
CAPTURE THOSE STORIES.
AND STORILY HAVE ON HAND STORIES
TO SUPPLEMENT WHATEVER KINDS OF
APPROACHES THAT WE HAVE TOWARDS
UNDERSTANDING OUR IMPACT.
RELATEDLY, WE WON'T BE ABLE TO
STUDY EVERYTHING THAT NIH DOES,
SO WE ALSO, RELATED TO BEING
ABLE TO TELL THE STORY IS TO BE
ABLE TO STUDY ACTUAL CASE
STUDIES.
CAN WE FUND GOOD EXAMPLES WHERE
SCIENCE HAS WORKED THE WAY WE
WANT TO WORK, AND HAS RESULTED
IN WAYS THAT WE HAVE CAPTURED IN
CHANGING HEALTH.
IN MEETING NIH'S MISSION.
CAN WE FIND THOSE STORIES AND
PACKAGE THEM IN A WAY THAT THE
PUBLIC CAN UNDERSTAND.
>> WE HAVE MANY OF THOSE
STORIES, SO YES.
>> YES, WE DO, AND OUR OFFICE,
THAT IS ONE OF THE THINGS THAT
OUR OFFICE WORKS ON AS WELL.
>> GREAT.
SO YOU SAN, PLE
>> SUSAN, GO AHEAD.
>> MARINA, THANK YOU FOR YOUR
COMMENTS.
ONE THING WE HAVEN'T MENTIONED
IS THAT BASIC RESEARCH SOMETIMES
IS BASIC RESEARCH AND IT'S NOT
REALLY -- DISCOVER FOR 15 OR 20
YEARS.
NIH KEEPS CHANGING, SOME
THOUGHTS ARE, YOU KNOW, FUNDED
TODAY BUT NOT FUNDED TOMORROW.
HOW CAN WE BE SURE THAT WE
REALLY -- FIRST WE SUPPORT BASIC
SCIENCE FOR THE SAKE OF
INVESTIGATING SOMETHING THAT IS
IMPORTANT, THAT MAYBE LATER ON
IT GOING TO BE USED FOR HUMAN
HEALTH AND TO IMPROVE THE HEALTH
OF THE AMERICANS, BUT HOW CAN WE
MAKE SURE THAT WE CAPTURE THE
STORIES AND WE LINK THEM ALL THE
WAY THROUGH THE YEARS TO CURRENT
DISCOVERIES?
>> YES, AND BELIEVE ME, WE HAVE
BEEN TALKING ABOUT THAT, BECAUSE
IN THE INSTANCE OF BASIC SCIENCE
TOO, HOW DO WE BEGIN TO SHOW HOW
A DISCOVERY HERE HAD SUCH
INFLUENCE IN SO MANY DIFFERENT
WAYS?
HOW DO WE SHOW THE DIFFUSION OF
THAT FINDING AND, YOU KNOW, FOR
EXAMPLE, CRISPR HAS BEEN USED
MANY TIMES TO SHOW JUST THAT.
THIS IS WHAT CRISPR HAS MEANT IN
SO MANY DIFFERENT AREAS.
HOW DO WE BEGIN TO BUILD MORE
EXAMPLES SUCH AS THAT, AND ONCE
WE HAVE THOSE EXAMPLE, WHAT DO
WE LEARN FROM THEM?
HOW DID THESE BASIC SCIENCE
DISCOVERIES, WH WHAT WAS IT ABOT
THEM THAT MADE THEM DIFFUSE A
CERTAIN WAY OR WHAT ABOUT THEM
CAN WE REPEAT IN FURTHER SUPPORT
OF BASIC SCIENCE.
>> THANK YOU VERY MUCH.
SOMETIMES THOSE FINDINGS ARE
SERENDIPITOUS, THEY'RE
INTERESTING, THEY'RE SO BASIC
THAT MAYBE WE DON'T EVEN KNOW
HOW THEY'RE GOING TO BE APPLIED.
THEY'RE JUST SUPER FUN AND
INTERESTING AND THEY NEED TO BE
PUBLISHED.
>> IS THERE A WAY LIKE YOU CAN
TAG A BIRD AND WATCH THE BIRD'S
MIGRATION, CAN YOU TAG AN IDEA
AND WATCH IT MIGRATE THROUGHOUT
SCIENCE?
WE HAVE TALKED ABOUT THAT QUITE
A BIT.
HOW DO YOU KNOW IN 20 YEARS WHEN
THIS ONE FINDING HAS RESULTED IN
MANY DIFFERENT IMPACTS?
>> THANK YOU.
I WOULD ALSO ADD FROM MY
PERSPECTIVE WHILE THIS IS
INCREDIBLY IMPORTANT TO
HIGHLIGHT SUCCESS STORIES.
PART OF THE SCIENCE OF SCIENCE
IS ALSO TAKING A CRITICAL AND
TRANSPARENT LOOK AT WHERE
RESEARCH HAS NOT SUCCEEDED.
AND UNDERSTANDING, YOU KNOW,
WHERE THERE ARE ALSO NEGATIVE
FINDINGS OR A LACK OF
TRANSLATION AND REALLY PUTTING A
TRANSPARENT LENS ON THAT SO THAT
WE CAN LEARN FROM OUR -- I DON'T
WANT TO SAY FAILURES BUT OUR
NEGATIVE JUST AS MUCH AS OUR
POSITIVE INSIGHTS.
SO THAT'S JUST ONE THING I WOULD
ADD TO THIS DISCUSSION.
KENT, AND THEN I THINK WE'LL
MOVE ON.
THANKS.
>> I JUST WANTED TO SAY, I THINK
IT'S A GREAT IDEA, I FULLY
SUPPORT IF WE'RE GOING TO VOTE
ON THIS TO PROCEED WITH A
WORKING GROUP.
THANKS.
>> OKAY.
WONDERFUL.
THANK YOU ALL FOR YOUR COMMENTS
AND YOUR IDEAS.
I DON'T THINK THAT THIS IS THE
DECISIONAL AGENDA ITEM SO THERE
WILL NOT BE A VOTE ON IT, BUT I
THINK IT'S CLEAR THAT THERE IS
SUPPORT FOR HAVING A WORKING
GROUP ON SCIENCE OF SCIENCE, SO
THANK YOU ALL FOR YOUR FEEDBACK
ON THAT.
SO OUR NEXT CONCEPT CLEARANCE IS
FROM THE OFFICE OF STRATEGIC
COORDINATION.
SO THIS NEW CONCEPT IS ENTITLED
THE CELLULAR SENESCENCE NETWORK
OR THE SENNET PROGRAM.
IT WILL BE PRESENTED BY THE NIA
DIRECTOR DR. RICHARD HODES.
THE PRESENTATION WILL BE
FOLLOWED BY COMMENTS FROM TWO
ASSIGNED COUNCILMEMBER
DISCUSSANTS, DRS. KENT LLOYD AND
DR. JENNIFER MANLY.
RICHARD, I'LL TURN IT OVER TO
YOU.
?REUSH
>> THANK YOU.
THANK YOU VERY MUCH FOR THE
OPPORTUNITY TO PRESENT.
JUST TO CLARIFY, THIS IS NOT A
NEW INITIATIVE.
THIS IS A REPORT BACK TO YOU ON
THE RESULTS OF THE FIRST PHASE,
WHICH WAS APPROVED AND MONITORED
BY THE COUNCIL, AND NOW WE HAVE
THE OPPORTUNITY TO PRESENT TO
YOU A PROPOSAL FOR MOVING ON
TOITY SECOND STAGE.
TO
ITS SECOND STAGE.
THIS IS AN OUTLINE OF THE
CONCEPT.
I'LL GO THROUGH IN SOME FURTHER
DETAIL THE PRODUCTIVITY OF THE
INITIAL INITIATIVE, THE PROCESS
THAT'S GONE INTO THE FORMULATION
OF THE PROPOSAL FOR THE SECOND
STAGE, AND THEN THE INFORMATION
WHICH MAY FEED INTO THE
INFORMATIONAL VOTE FOR APPROVAL
AGAIN AT THE EXTENSION TO PHASE
TWO OF THE SENNET PROGRAM.
SO THANKS FOR ALL WHO HAVE BEEN
WORKING OVER THE PAST NEARLY
FIVE YEARS ON THIS.
DANA SINGER, PARTNER FROM NCI
WITH NIA, HAVE BEEN -- ALL THOSE
YOU CAN SEE HERE REPRESENTING
INPUT FROM MULTIPLE OF THE
INSTITUTES AT NIH BECAUSE
INDEED, IT TURNS OUT TO BE
SOMETHING OF IMPORTANCE TO THE
BASIC AND TRANSLATIONAL MISSIONS
OF NEARLY EVERY ONE OF THE NIH
INSTITUTES.
JUST A BACKGROUND ON CELLULAR
?ESENESCENCE, IT ONLY APPEARED S
A REALITY IN THE 1960s WHEN IT
WAS FIRST NOTED THAT CELLS,
NORMAL CELLS, NON-MALIGNANT
CELLS, EVEN IN TISSUE CULTURE,
HAD A FINITE REPLY KAYTIVE
CAPACITY.
THEY DON'T JUST SIT THERE,
THOUGH, THEY HAVE
CHARACTERISTICS WHICH ARE AN
IMPORTANT PART OF THEIR BIOLOGY.
THEY HAVE NORMAL BIOLOGICAL
ROLES FOR THINGS SUCH AS WOUND
HEALING AND EMBRYONIC
DEVELOPMENT.
THEY ALSO PLAY A ROLE AS THEY
ACCUMULATE IN NEARLY ALL PEE ALS
EXAMINED, CONTRIBUTING TO AGING
CONDITIONS AND DISEASES.
THEY'RE VERY RARE SO THEIR
NUMBERS ARE SMALL, EVEN THOUGH
THEIR IMPLICATIONS AND
CONSEQUENCES ARE GREAT, AND THE
MECHANISMS THAT ARE POSSIBLE FOR
THE SENESCENCE GOING INTO THIS
MISSION IN PARTICULAR, ARE NOT
VERY WELL UNDERSTOOD AT ALL.
THENCE THE NETWORK WAS LAUNCHED
FIVE YEARS AGO TO STUDY
SENESCENT CELLS AND THEIR ROLE
IN HEALTHY AGING AND DISEASE.
SO A BIT OF THE IMPACT FIRST.
I'LL GO THROUGH THE SPECIFIC
COMPONENTS OF THE PROGRAM, BUT
THE PRODUCTIVITIES INCLUDE THE
GENERATION OF SOME 1300 DATASETS
OVER 780 THEM NOW PUBLISHED.
MANY OF THE OTHER PROTOCOLS FOR
STUDY OF SENESCENCE PUBLISHED.
TO THE RIGHT YOU SEE A SUMMARY
OF THE TISSUES OF ORIGIN, AND
THE KINDS OF MULTIPLE OMIC
ASSAYS THAT HAVE BEEN CARRIED
OUT TO CHARACTERIZE THESE CELLS.
THIS IS A NETWORK VISUALIZATION
OF THE WAY IN WHICH SOME 15
ORGANS STUDIED SORTED OUT IN
SENNET AS IT'S BEEN DEFINED OVER
THESE PAST YEARS.
IN ADDITION TO IDENTIFYING THE
SENESCENT CELLS AND THEIR
HETEROGENEITY, THE PROCESS OF
DOING SO REQUIRED DEVELOPMENT OF
NOVEL TOOLS AND TECHNOLOGY, SOME
OF WHICH ARE LISTED HERE, SO FOR
EXAMPLE, A RADIO TRACER THAT
VISUALIZES, HERE AMENABLE NOW TO
PET AND MRI IMAGING AS WELL AS
SEVERAL YOU'LL SEE
BIOINFORMATICS TISSUES,
TRANSCRIPTOMICS AND SPATIAL
TRANSCRIPTOMIC TECHNIQUES.
WHAT I'LL SAY IS REMARKABLE
THESE PAST FIVE YEARS IS THAT
THE TECHNIQUES TO DEVELOP THE
INITIAL STAGE IT'S AT ACTUALLY
WERE LARGELY A RESULT OF THE
INITIAL PHASE, AND WHEN WE GO
FURTHER, ARTIFICIAL INTELLIGENCE
BARELY CONCEPTUALIZED FIVE YEARS
AGO AS ADDED ENORMOUSLY TO THE
PROSPECTS OF WHAT WE'RE
PROPOSING TO YOU TODAY.
SO THE IMPACT IN TERMS OF
PUBLICATIONS, AN EASY THING TO
MEASURE, YOU CAN SEE IN THE
FIGURE TO THE LEFT.
THE NUMBER OF PUBLICATIONS.
INCREASING TRULY EXPONENTIALLY
INTO 2024.
IT INVOLVES SOME VERY HIGH LEVEL
HIGH PROFILE PUBLICATIONS THAT
HAVE PROVIDED RECOMMENDATIONS
FOR HOW TO STUDY AND DETECT
SENESCENT CELLS, AND THEN THE
USE OF TECHNIQUES SUCH AS
SPATIAL MAPPING OF CELLULAR
SENESCENCE AND THE OPPORTUNITIES
THAT IT CREATES.
SO A SUMMARY OF THE PLANNING
ACTIVITIES WITH REGARD TO THE
SECOND PHASE, FOCUS GROUPS THAT
INVOLVE CONSORTIUM PIs IN THE
FIRST STAGE ITSELF AS WELL AS
WORKING GROUP MEMBERS, EXPERT
PANELS CONVENED AND PROGRAM
CONSULTANTS.
THE SUMMARY WAS THAT WE NEED TO
DEFINE THE BIOLOGICAL RELEVANCE
OF THE SENESCENCE HETEROGENEITY
WHICH APPEARED IN THIS FIRST
PHASE AND UNDERSTAND IN TERMS OF
THE MECHANISMS THAT MEDIATE
CELLULAR SENESCENCE, ALL AS A
GUIDE TO THE WAY IN WHICH
MANIPULATION OF SENESCENT CELLS
CAN BE USED TO THERAPEUTIC
ADVANTAGE.
IMPORTANCE OF DEVELOPING
PRE-CLINICAL MODELS IN WHICH THE
VALIDATION OF INTERVENTIONS TO
AFFECT SENESCENT CELLS CAN BE
STUDIED.
STUDY SENESCENT CELLS NOT JUST
IN HUMAN NORMAL TISSUES BUT IN
THE CONTEXT OF DISEASE AS WELL,
ASPECTS OF SENESCENCE AND
SENESCENT CELLS ARE PATHOGENIC.
AS I ALLUDED TO, DEVELOPING
CUTTING EDGE TOOLS INCLUDING AI
FOR SENESCENT CELL SIGNATURES
AND PREDICTIONS AND THEN
IMPORTANTLY TOO, THE CONTEXT OF
THE COMMON FUND AND OUR BROAD
DATA INITIATIVES TO STUDY THE
ENHANCED INTEGRATION OF SENNET
WITH OTHER SINGLE CELL CONSORTIA
IN THE COMMON FUND AND WITHOUT
SO THE HUMAN TUMOR ATLAS, THE
HUMAN BIOLOGICAL MAP OF SPATIAL
TEMPORAL EXPRESSION IN NORMAL
TISSUES AND SOMATIC MOSAICISM,
ALL OF THESE IN A COMMON DATA
NETWORK WHICH ALLOWS THE OPTIMAL
CROSS INFORMATION AND LEVERAGING
OF THE SEVERAL INITIATIVES
INCLUDING SENNET.
SO PORTFOLIO ANALYSIS WAS PART
OF THE SURVEY OF WHERE WE'VE
COME FROM.
FOR 2015 THROUGH 2024, IN THESE
YEARS, IF WE LOOKED AT THE
TOPICS WHICH WERE SUBJECT OF
SENNET STAGE ONE, SO CELLULAR
SENESCENCE, SINGLE CELL SPATIAL
TISSUE MAPPING OF THE 29 AWARDS
FROM NIH IN THAT TIME, 22 WERE
IN SENN ET, TO GIVE AN IDEA OF
WHAT A PROFOUND IMPACT THIS
INITIATIVE HAS HAD IN
ACCELERATING RESEARCH IN THIS
AREA, THE SAME HOLDS TRUE FOR
THE OTHER AREAS OF RESEARCH
AROUND SENESCENCE.
SO ALREADY, THIS SENNET HAS
PERFORMED ITS INITIAL TASK IN
PROVIDING THE FIELD WITH A
DYNAMIC BEGINNING, THE TOOLS AND
KAY DATABASES ON WHICH TO PROCE.
THE ANALYSIS AND INPUT OF
VARIOUS EXPERT CONVENINGS
CONCLUDED THAT SENNET INVESTMENT
IS NEEDED FIRST TO UNDERSTAND
THE HETEROGENEITY -- BEYOND WHAT
WAS EXPECTED, HETEROGENEITY IN
TERMS OF BIOCHEMICAL SIGNATURES
AT A CELLULAR LEVEL, BIOLOGY OF
SENESCENCE AT A SINGLE CELL
LEVEL, AGAIN IN NORMAL AND
DISEASE STATE STATES TO UNCOVERD
VALIDATE BIOMARKERS THAT CAN BE
USED IN ULTIMATELY CLINICAL
MODELS, DEVELOP THE TWO
TECHNOLOGIES TO DO SO, AND TO
INTEGRATE THE RESULTS OF STAGE
ONE WITH WHAT THE MAPPING
EFFORTS WILL BE IN STAGE TWO TO
JEB RGENERATE A SEARCHABLE ATLAF
SENESCENT CELLS.
SO SENNET GOALS AND INITIATIVES,
TO UNDERSTAND THE BIOLOGICAL
RELEVANCE OF SENESCENT CELLS AND
HETEROGENEITY, TO IDENTIFY AND
VALIDATE DIVERSE SENESCENT
SIGNATURES IN HUMAN BIOSPECIMENS
AND INFORM SENOTHERAPEUTIC
STRATEGIES FOR HUMAN HEALTH, ALL
BASED ON THE FINDING THAT
SENESCENT CELLS AND THEIR
MANIPULATION OF ANIMAL MODELS
SEEM TO HAVE IMPACT ON MULTIPLE
DISEASES AND CONDITIONS AND SO
THE INTERVENTIONS ON SENESCENT
CELLS MIGHT INDEED HAVE IMPACTS
ON MULTIPLE OF THE CONTRIBUTIONS
TO HUMAN HEALTH.
THE STAGE TWO INITIATIVE ALSO BE
DISCOVERY, MAPPING AND
VALIDATION CENTERS.
THE SENESCENCE TECHNOLOGY
PROJECTS TO FURTHER DEVELOP
TECHNOLOGY NEEDED TO STUDY
SENESCENT CELLS IN VIVO AS WELL
AS IN VITRO AND A DATA
COORDINATION OF INTEGRATION AND
ORGANIZATIONAL CENTER TO MAKE
THESE MAXIMALLY AVAILABLE AND
LEVERAGABLE IN THE BROADER
RESEARCH COMMUNITY.
SO THE FIRST INITIATIVE
DISCOVERY AND MAPPING WILL BE A
SERIES OF MAPPING VALIDATION
CENTERS, WHICH WILL USE STATE OF
THE ART TECHNIQUES, MANY OF
WHICH HAVE BEEN DEVELOPED BY THE
FIRST PHASE OF THIS INITIATIVE
TO DEFINE ORGAN SPECIFIC
SENOTYPES AND THEIR FUNCTION IN
HEALTH DEVELOPMENT AND IN
DISEASE CONDITIONS, AND
IMPORTANTLY TO IDENTIFY
PRE-CLINICAL MODELS WHICH ALLOW
THE PERTURBATION AND INDUCTIONS
OF SENESCENCE MODULATION OF
SENESCENCE TO TEST AND TO
VALIDATE SENOSPARE PEW PUGH
TICKS AND STRATEGIES TOWARDS
TRANSLATIONAL AND CLINICAL
APPLICATION.
SECOND PHASE TO USE INTEGRATED
SYSTEMS BIOLOGY APPROACHES THAT
LEVERAGE MULTIPLE SCIENTIFIC
DISCIPLINES THAT WILL BRING TO
BEAR ALL OF THE FINDINGS FROM
THE BASIC SCIENCE TO ADVANCE
CURRENT UNDERSTANDING AND
RELEVANCE TO SENESCENCE
HETEROGENEITY, TO DEVELOP
TECHNOLOGIES AND MULTI-SCALE
MODELS TO DETERMINE CELLULAR
SENESCENCE AND IMPORTANTLY IN
VIVO OUTCOMES, TO USE
DEVELOPMENTAL COMPUTATIONAL
TOOLS SUCH AS THE AI THAT I
MENTIONED SEVERAL TIMES IN
CARRYING OUT THIS TRANSLATION.
THIRD COMPONENT INITIATIVE
THREE, TO HAVE A DATA
COORDINATION AND INTEGRATION
CENTER THAT WILL MAKE AVAILABLE
THE OUTCOMES OF THESE DATA TO
THE RESEARCH PUBLIC AND AS I
NOTED AT THE OUTSET IN
COLLABORATION WITH SOME OF THE
OTHER CELLULAR LARGE SCALE DATA
INITIATIVES THAT ARE IN PROGRESS
ALL IN GENERATING INTERACTIVE
ATLASES THAT WILL MAXIMIZE THE
IMPACT OF THE SEVERAL EFFORTS.
PROPOSAL MEETS COMMON FUND
CRITERIA, REMAINS NOVEL THE WAY
IT'S CONTRIBUTED TO THE FIELD
ALREADY.
HAS TRANSFORMED THE IDEA OF
MOVING SENESCENCE RESEARCH
FORWARD INTO THERAPEUTIC
TRANSLATIONS.
HAS CATALYZED THIS WORK AS YOU
CAN SEE BY THE ENORMOUS IMPACT
THAT THE SENNET STUDIES THEM
SELVES HAVE IT ON THE FIELD,
GIVEN BY THE SAME GOALS THAT
MOTIVATED TO BEGIN WITH AND
SYNERGIZE ACROSS INSTITUTES,
CENTERS AND OFFICES ACROSS THE
ENTIRE LIFESPAN.
SO THE SENESCENCE SENNET STAGE
II BUDGET ILLUSTRATED HERE, THE
FIRST COMPONENT, THE DISCOVERY
AND MAPPING VALIDATION CENTER,
APPROXIMATELY 8 TO 10 OF THEM AT
ABOUT $2 MILLION EACH FOR
$20 MILLION PER YEAR FOR THE
FIVE-YEAR DURATION OF THE
PROPOSED EXTENSION.
THE TECHNOLOGY CENTERS AT
APPROXIMATELY A MILLION EACH,
ANOTHER 6 TO 8 OF THESE CENTERS,
AND THEN A COORDINATING CENTER
OF $3.4 MILLION SO THE OVERALL
PROPOSAL WITH ADMINISTRATIVE
EXPENSES IS APPROXIMATELY
$30 MILLION PER YEAR FOR EACH OF
FIVE YEARS.
THE DELIVERABLES WILL BE CURATED
SEARCHABLE AT LESSES OF SENOTYPE
BIOLOGY IN HEALTH AND DISEASE,
IMPROVED ANIMAL AND RELEVANT
PRE-CLINICAL MODELS TO
ACCELERATE SENOTHERAPEUTIC
INTERVENTIONS AND INNOVATIVE
TOOLS AND TECHNOLOGIES TO
PREDICT BIOLOGICAL OUTCOMES OF
INTERVENTIONS IN VIVO.
ACTION WE'RE ASKING OF THE
COUNCIL IS TO CONSIDER FOR
APPROVAL EXTENSION OF THIS
CONCEPT FROM A VERY PRODUCTIVE
PHASE 1 INTO THE SECOND STAGE,
STAGE TWO OF CELLULAR SENESCENCE
PROGRAM.
I'D BE HAPPY TO ADDRESS ANY
QUESTIONS YOU MIGHT HAVE, AND
THANK YOU FOR THE OPPORTUNITY TO
TALK WITH YOU.
>> THANK YOU, RICHARD.
AND I MUST JUST TAKE A QUICK
SECOND TO APOLOGIZE FOR
MISSPEAKING DURING THE INTRO.
THE ADJECTIVE "NEW" SHOULD
OBVIOUSLY BE APPLIED TO ME AND
NOT TO THIS PROGRAM.
AND SO I REALLY APPRECIATE YOU
GIVING US SUCH A DETAILED
OVERVIEW OF THE TRANSFORMATIVE
IMPACT THAT IT'S ALREADY HAD AND
THE PROPOSAL TO MOVE TO STAGE
II.
SO DR. LLOYD, WOULD YOU PLEASE
SHARE ANY COMMENTS WITH THE
COUNCIL.
>> SURE.
THANKS.
YOU KNOW, IN THE INTEREST OF
TIME, NORMALLY I WOULD PROVIDE A
SUMMARY OF WHAT DR. HODES
PRESENTED BUT I THINK WE ALL GET
IT AND JUST TO CUT TO THE CHASE.
I HAVE A FEW QUESTIONS IF YOU
DON'T MIND.
FIRST CAN YOU CLARIFY FOR ME,
BECAUSE ONE OF YOUR SLIDES SHOWS
A PORTFOLIO ANALYSIS FROM 2015
TO 2024 ASSOCIATED WITH SENNET
GRANTS DURING THAT TIME.
SO I NEED TO GET CLARIFICATION,
NORMALLY COMMON FUND PROGRAMS
ARE 10 YEARS IN LENGTH.
HAVE YOU ALREADY HAD 10 YEARS
FOR STAGE ONE?
AND THIS IS NOW THE NEXT FIVE --
ANOTHER FIVE YEARS, OR CAN YOU
EXPLAIN THAT SLIDE?
I DON'T UNDERSTAND.
>> THANK YOU FOR THE QUESTION.
I APOLOGIZE, I SEE THE CONFUSION
IN THE SLIDE.
THE SENNET INITIATIVE BEGAN FIVE
YEARS AGO, AND THE PROPOSAL IS
FOR AN EXTENSION FOR THE NEXT
FIVE YEARS.
THE LONGER TIME FRAME YOU SAW
THERE WATI WAS THE TIME FRAME OR
WHICH LITERATURE WAS SURVEYED
FOR TOPICS RELATED TO SENNET
OVER THAT ENTIRE 10-YEAR
HISTORY.
THE SENNET SUPPORTED STUDIES, A
VAST MAJORITY OF RESEARCH IN
THAT AREA.
SO IT'S BEEN YEARS OF RESEARCH
BUT VERY LITTLE OF IT ACTIVE
THAT PRECEDED THE FIVE YEARS OF
STAGE ONE OF THIS SENESCENCE
PROGRAM.
>> OKAY, THANK YOU FOR CLEARING
THAT UP.
THAT WAS A MAJOR CONFUSION ON MY
PART.
THE SECOND THING IS ON ONE OF
YOUR SLIDES, YOU SHOWED THE STIJ
ONE IMPACT, BUT IT APPEARED TO
ME, THERE WAS REALLY NO COMPLETE
DATASET FOR ANY OF THE TISSUES
THAT WERE STUDIED.
WAS THAT THE GOAL OF THE FIRST
PHASE?
IT LOOKED HIGHLY VARIABLE.
SO I WONDER IF YOU COULD COMMENT
ON THAT.
>> YES, S THE SLIDE ILLUSTRATES
THE NUMBER OF STUDIES THAT WERE
PUBLISHED, AS WELL AS THE NUMBER
UNDER QC OR QUALITY ASSESSMENT.
IN THESE FIRST YEARS, THE
SUCCESS HAS BEEN TO GENERATE
THESE LARGE DATABASES, AND
PROVIDE THEIR ABILITY TO THE
PUBLIC NOW FOR FULL ANALYSES.
SSO THE DATA ARE SO EXTENSIVE
THAT AT THE END OF FIVE YEARS,
IT'S BEEN AN EXTENSIVE
COLLECTION, THE ANALYSES IS NOW
BEING CARRIED OUT BY THE
MULTIPLE OW OMICS YOU SAW IN TH.
SO THE SPECIMENS ARE COLLECTED
AND NOW THE IN PROGRESSOR
MULTIPLE OMIC DIMENSIONS OR
STRATEGIES.
>> OKAY.
SO THAT TABLE IS, THEREFORE,
INCOMPLETE BECAUSE THE ANALYSIS
CONTINUES.
>> CORRECT.
>> MY CONCERN IS THAT UNLESS YOU
HAVE A COMPLETE DATASET FOR ALL
THE TISSUES, IT WILL BE IN THE
FIRST PHASE IN WHICH YOU'RE
DEVELOPING BIOMARKERS AND YOU
DEVELOP NEW TOOLS, YOU KIND OF
NEED THAT TO MOVE ON TO THE NEXT
PHASE IN WHICH YOU'RE LOOKING AT
BIOLOGICAL NETWORKS IN BOTH
HEALTHY TISSUE AND DISEASED
TISSUE AND SO ON.
>> VERY WELL TAKEN.
AND IN FACT, TO BE EVEN MORE
STRAYED FORWARD ABOUT IT, THE
PHASES ARE DYNAMIC, AREN'T THEY?
SO WE'LL CONTINUE TO HAVE MORE
AND MORE ANALYSES WITH THE
ASSAYS WE KNOW AND THE ASSAYS
THAT WILL BE DEVELOPED, AND AS
WE HAVE INCREASING INFORMATION,
THAT WILL ALL FEED INTO THE
ABILITY OF PHASE TWO TO
TRANSLATE THAT INTO NEXT STEPS
OF TRANSLATION AND CLINICAL
APPLICATION.
>> OKAY.
LASTLY, QUESTION ON THE SCIENCE
THEN.
THERE'S OBVIOUSLY A FOCUS ON
SENESCENCE BUT I WAS CURIOUS AS
TO WHETHER THERE WILL BE ANY
TYPE OF INVESTIGATION INTO THE
RELATIONSHIP BETWEEN A CELL
ENTERING SENESCENCE VERSUS ONE
THAT ENTERS APOPTOSIS, WHICH IS
OBVIOUSLY DEATH OF A DEATH OF ,
IRREVERSIBLE, VERSUS A CELL THAT
REACHES -- I WONDER IF THERE
WILL BE AN ANALYSIS OF THAT AND
FINDING WAYS OR PERHAPS
EXPLAINING MECHANISMS OF HOW A
CELL MAY POTENTIALLY MOVE
BETWEEN THOSE DIFFERENT PHASES.
>> THAT'S A GREAT QUESTION.
AND THERE IS A LOT OF ACTIVE
RESEARCH BEING PROPOSED AND
BEING FUNDED ADDRESSING JUST
THOSE QUESTIONS IN A NUMBER OF
CELL TYPES.
SO CELLULAR SENESCENCE WAS
INITIALLY DEFINED AS
IRREVERSIBLE.
YOU MAY NOTE NOW MORE OFTEN IT'S
THOUGHT AS MORE DURABLE BECAUSE
THERE MAY BE CONDITIONS UNDER
WHICH IT CAN BE REVERSED.
APOPTOSIS AS YOU SAID IS CELL
DEATH, BY DEFINITION,
IRREVERSIBLE, AND QUIESCENCE,
YES IS A STAGE OF RELATIVE
INACTIVITY, BUT WHICH IS MORE
EASILY REVERSIBLE.
CELLULAR SENESCENCE IS NOT A
STAGE OF DORMANCY AND PERHAPS I
COULD HAVE EMPHASIZED THAT MO
BUT THE PHYSIOLOGIC METABOLIC
ACTIVITY OF HE?
SEPTESENESCENT CELLS, THESECRETF
SECRETEOME, THE CELLS DON'T JUST
STOP CAN I VIEDING AND SIT THERE
IN SMALL NUMBERS.
THEY'RE HIGHLY ACTIVE.
QUIESCENT CELLS ARE COMMONLY
REGARDED AS CELLS WHICH ARE TRUE
LIE FUNCTIONALLY QUIESCENT
BUT -- AS YOU POINT OUT THE
DETERMINANTS THAT PROTECT
SENESCENT CELLS, ONE OF THE
CHARACTERISTICS OF SENESCENT
CELLS IS THE FACT THAT THEY ARE
RESISTANT TO APOPTOSIS AND ONE
OF THE STRATEGIES FOR
ELIMINATING THOSE CELLS I HAS TO
BLOCK THEM FROM THE PATHWAY OF
APOPTOSIS.
SO MORE IS KNOWN ABOUT THE
CHOICE POINTS BETWEEN DEATH AND
PREVENTION OF DEATH AND
PRESERVATION OF THE SENESCENCE
BEING INTACT.
>> THANK YOU, DR. HODES.
THE PHASE ONE LOOKS LIKES IT'S
BEEN VERY, VERY PRODUCTIVE OR
SUCCESSFUL, CONTINUE TO WORK ON
SOME OF THOSE DATASETS.
THE TOOLS THAT WERE DEVELOPED,
VERY RIGOROUS AND WILL BE
APPLICABLE TO THE SECOND PHASE.
DR. HODES, YOU PRESENTED VERY
STRONG JUSTIFICATION OF WHY THIS
CONTINUES TO MEET THE CRITERIA
FOR COMMON FUND PROGRAMS SO I
WOULD SUPPORT THE EXTENSION INTO
PHASE TWO OF THIS PROGRAM FOR
ANOTHER FIVE YEARS.
THANK YOU.
>> THANK YOU FOR THE QUESTIONS
AND THE CHANCE TO DISCUSS IT
WITH YOU.
>> THANK YOU.
DR. MANLY, WOULD YOU LIKE TO ADD
ANY COMMENTS?
>> JAN!
>> HI, HI, RICHARD.
IT'S SO GOOD TO SEE YOU.
I'M GOING TO TURN MY CAMERA OFF
BECAUSE I'VE BEEN HAVING SOME
CONNECTION IRK E ISSUES TODAY AM
GOING TO ASK SOME QUESTIONS THAT
YOU MAY FIND A LITTLE IRRITATE,
I'M AFRAID.
THEY'RE VERY GENERAL.
I AM IN FAVOR OF THIS SCIENCE, I
AGREE WITH DR. LLOYD THAT IT IS
RIGOROUS, THAT YOU'VE MADE -- BY
EVALUATING SOME OF THE
CHALLENGES THAT CAME UP IN STAGE
ONE, YOU'VE PLANNED YOUR SECOND
STAGE, I THINK, THOUGHTFULLY AND
APPROPRIATELY.
BUT I THINK I NEED MORE
INFORMATION ABOUT THE CRITERIA
FOR CONTINUING ANY COMMON FUND
PROGRAM BEYOND THE FIRST FIVE
YEARS.
SO ONE EXAMPLE OF MY QUESTION
IS, WHAT'S THE RATIONAL FOR
KEEPING SENNET WITHIN THE COMMON
FUND.
IN OTHER WORDS, HOW IS THIS
BETTER THAN IC-DRIVEN PROGRAMS?
HOW HAS THE COST-EFFECTIVENESS
OF PHASE ONE BR BEEN EVALUATED N
THE CONTEXT OF ITS DOWNSTREAM
IMPACT?
YOU SPENT SOME TIME DISCUSSING
WITH US THE CATALYTIC AND
TRANSFORMATIVE CRITERIA OF
COMMON FUND PROGRAMS.
MY QUESTION TO YOU IS, HOW WILL
THE ACCELERATION OF SENESCENCE
RESEARCH BE MEASURED BY THIS
PROGRAM?
YOU IN YOUR SLIDES INCLUDED
SENNET GRANTS IN THAT, BUT IS
THAT REALLY HOW WE SHOULD BE
MEASURING HOW A COMMON FUND
PROGRAM ACCELERATES SCIENCE IN A
PARTICULAR AREA?
IS THAT -- IT FUNDS GRANTS
WITHIN ITS PROGRAM?
THEN MY FINAL QUESTION IS, HOW
HAS THE SENNET PROGRAM BENEFITED
VULNERABLE POPULATIONS, PATIENT
GROUPS, AND HOW HAS IT -- HAS IT
BEEN TAKEN UP BY A
REPRESENTATIVE RANGE OF
INSTITUTIONS?
AND I'LL PUT THESE QUESTIONS IN
THE CHAT BECAUSE I KNOW IT'S
ALO.
>> SORRY.
I'LL TRY TO GET THROUGH THEM,
JEN.
THE FIRST WAS AN IMPORTANT
GENERAL QUESTION, WHEN SHOULD
COMMON FUND PROGRAM LIKE SENNET
BE EXTENDED, HOW DO WE KNOW IT
SHOULD BE EXTENDED RATHER THAN
HAVING COMPLETED ITS GOALS.
IT'S A CHALLENGING QUESTION AND
IT SHOULDN'T BE TAKEN LIGHTLY.
I WOULD SAY IN THE CASE OF
SENNET AS I'VE ILLUSTRATED,
WE'VE LEARNED A GREAT DEAL ABOUT
THE HETEROGENEITY OF SENESCENT
WE DIDN'T KNOW BEFORE, FROM
TISSUE TO TISSUE AND IN
DIFFERENT SETTINGS, WE HAVE THE
DATASETS THAT REX TENSIVE BUT
NOT COMPLETE, AND IF THE GOAL IS
TO PROVIDE ATLASES WHICH WERE
EXPRESSED EX-!
PUBLICITILY AS A GOAL, THAT THEN
SHOULD BE EASILY ACCESSIBLE AND
USABLE BY THE RESEARCH
COMMUNITY, THAT'S THE STATE AT
WHICH I THINK THE COMMON FUND
INITIATIVE SUCH AS THIS WILL
HAVE ACCOMPLISHED ITS MISSION, I
THINK WITHOUT THE SECOND STAGE,
WE WOULD HAVE BEEN SUCCESSFUL IN
PROVOKING MORE RESEARCH BUT NOT
NEARLY AS EXTENSIVELY AS WOULD
BE THE CASE AFTER A SECOND
PHASE, COMPLETED ATLASES, WELL
ANNOTATED AND ACCESSIBLE TO THE
RESEARCH COMMUNITY.
RELATED TO YOUR SECOND POINT, I
THINK WAS ABOUT HOW DO WE
MEASURE SUCCESS, AND CLEARLY
JUST THE FACT THAT WE HAVE
FUNDED PUBLICATIONS BY A COMMON
FUND INITIATIVE ITSELF ARE NOT
SUFFICIENT, ONE, RELATIVELY
PROXIMATE OUT COME WOULD BE WHEN
THE FIELD TAKES OFF AND NOW
RESEARCH IN THE FIELD OF A
COMMON FUND INITIATIVE LIKE
SENNET IS BEING SUPPORTED BY
GRANTS OUTSIDE OF SENNET ITSELF,
I WOULD EXPECT TO SEE IN THE
NEXT YEARS A GROWING AMOUNT OF
THIS AND EVEN MORE ACCELERATION
WE APPROACH THE END OF WHAT I
HOPE WILL BE THE SECOND PHASE,
ALLOWING INVESTIGATORS TO ENTER,
SO A MEASURE OF SUCCESS WE'VE
USED, JEN, I THINK YOU'VE SEEN
IN OUR OTHER INITIATIVES, WE GET
TO THE STAGE WHERE INVESTIGATORS
WERE NEVER EVEN FUNDED BY THE
INITIATIVE ITSELF, LIKE SENNET,
I THINK THAT'S A CRITERION THAT
WE'VE CATALYZED THE FIELD AND WE
CAN STEP BACK AND BE GRATIFIED
IN THAT.
YOUR THIRD AND FINAL QUESTION,
HIGH IN MIND FOR ALL WE DO, HOW
THIS PE BENEFITS PEOPLE,
POPULATIONS, THE FULL SCOPE OF
THE AMERICAN GLOBAL POPULATIONS.
THE FACT THAT IN THE
PRE-CLINICAL ANIMAL MODELS, THE
REVERSAL OF SENESCENCE AND
ELIMINATION OF SENESCENT CELLS
HAS SHOWN PROMISING IMPACTS ON
VARIETIES OF AGE-RELATED
PATHOLOGIES, GIVES US STRONG
CONFIDENCE, THOUGH WE NEVER KNOW
UNTIL THE END PRODUCT, THAT BY
INTERVENING ON SENESCENT CELLS,
WE'LL BE IMPACTING MANY ASPECTS
OF AGING, THE PRECURSORS TO MANY
CONDITIONS AND DISEASES, WHICH
AFFECT VERY DIVERSE POPULATIONS.
SO THERE'S NO QUESTION THE BASIC
SCIENCE SEEMS RELEVANT TO THOSE
DISEASE AND CONDITIONS WHICH
IMPACT DIVERSE POPULATIONS.
THE FINAL MOUNTAIN TO ACHIEVE
AND TO CLIMB, OF COURSE, IS TO
TRANSLATE INTO INTERVENTIONS
WHICH THEN CAN AND WILL BE
APPLIED IN THOSE DIVERSE
POPULATIONS THAT WE ARE TALKING
ABOUT.
UNTIL THAT, WE DON'T HAVE THE
FINE SUCCESS THAT I THINK WE
ASPIRE AND FEEL IS A PROMISE YET
TO BE ACHIEVED AND DEMONSTRATED
BY THE INITIATIVE.
SO I THINK THOSE ARE YOUR THEE
POINT.
S.
>> JUST ONE MORE ADDITION TO THE
LAST ONE, WHICH IS HAVE THE
SENNET GRANTS BEEN AWARDED TO
REPRESENTATIVE SET OF
INSTITUTIONS THAT ARE ELIGIBLE
FOR NIH GRANTS?
>> THAT'S A GOOD QUESTION, AND
REPRESENTATIVES IS A CHALLENGING
PART OF THE QUESTION, I DON'T
KNOW.
MULTIPLE AWARDS TO MULTIPLE
INSTITUTIONS THAT ARE GENERALLY
RESEARCH ONE INSTITUTIONS, BUT
FAIR TO TAKE A LOOK.
AND YOU KNOW, IF THERE'S A
SECOND PHASE COMING UP AND WE'RE
LOOKING AGAIN AT THE OUTCOMES OF
A SECOND ADVERTISEMENT, I SHOULD
SAY THAT THE PLAN IS FOR STAGE
TWO, NOT TO LIMIT THAT TO JUST
THOSE SUCCESSFUL SITES IN THE
FIRST PHASE BUT VERY EXPLICITLY
TO HOPE THAT MORE AND A BROADER
SPECTRUM OF INSTITUTIONS WILL BE
CAPABLE OF GENERATING PROPOSALS,
AND I WOULD ALSO POINT OUT I
THINK IT'S BEEN A RULE RATHER
THAN AN EXCEPTION, THAT THESE
PROPOSALS HAVE COME FROM COP
CONSORTIA OF INSTITUTIONS, EACH
OF THE INDIVIDUAL AWARDS ITSELF
IS FROM A CONSORTIUM, SOMETHING
TO BE RECOGNIZED, AND ANOTHER
ASPECT OF THE SENNET ACTIVITIES
THAT WAS NOT STRESSED IN THE
SCIENCE ASPECT WAS I THINK A
VERY SUCCESSFUL MODEL OF
DEVELOPING A PROGRAM FOR NEW,
YOUNG AND EMERGING INVESTIGATORS
AND SOME THROUGH TRAINING TO
EXPERIENCE RESEARCH IN THE
PROGRAMS VERY EXPLICITLY, JEN,
INTENDING THOSE TO BE A NEXT
INCLUSIVE GENERATION OF PEOPLE
WHO MAY NOT EVEN HAVE BEEN IN
MANY OF THESE CASES AT THE
INSTITUTIONS THAT GOT THE FIRST
AWARD.
SO I THINK THERE'S BEEN A VERY
CONSCIOUS EFFORT TO BROADEN THE
RESEARCH COMMUNITY THAT IS
LIKELY TO BE INVOLVED IN THE
SECOND PHASE OF RESEARCH, AND
BEYOND, AND CREDITS TO EVEN
BEYOND THE RESEARCH
ACCOMPLISHMENT ITSELF TO THE
WORK OF THIS CONSORTIUM.
>> RICHARD, I'LL JUST ADD ON
THAT LAST POINT, THIS IS
CAROLYN, TO SAY THAT WE ARE ALSO
DOING THAT NOT JUST WITHIN
SENNET BUT SENNET LTS ALSO
PARTICIPATES IN OUR LARGER
HECOSIS TEM AND WE HAVE SOME
ACTIVITIES WITHIN THAT DATA
ECOSYSTEM INCLUDING
R03 OPPORTUNITIES FOR PEOPLE TO
COME IN AND USE THE EXISTING
DATASETS FROM SENNET OR OTHER
PROJECTS EITHER INDIVIDUALLY OR
TOGETHER AS WELL AS TRAINING AND
EDUCATION, OUTREACH ACTIVITIES
WITHIN THAT PROGRAM THAT ALSO
HELP BROADEN THE SCOPE NOT JUST
OF WHO'S GETTING SOME COMMON
FUND FUNDING TO WORK WITH SENNET
AND DATA BUT ALSO GETTING THAT
EXPOSURE AND THE ABILITY TO SORT
OF USE THAT COMMON FUND
RESOURCES.
>
>> THANKS, CAROLYN.
>> AND I MIGHT ASK, CAROLYN, IF
YOU JUST TO ENSURE THAT WE HAVE
ADDRESSED ALL OF DR. MANLY'S
QUESTIONS, IF YOU MAYBE WANT TO
EXPAND A LITTLE BIT ON SORT OF
THE RATIONALE FOR KEEPING SENNET
WITHIN COMMON FUND AND HOW THIS
TYPE OF A TRANSFORMATIVE
CROSS-CUTTING RESEARCH PROGRAM
IS REALLY BEST SUPPORTED BY A
COMMON FUND THAT ALLOWS -- THE
COMMON FUND AS A PROGRAM
ALLOWING US TO WORK
COOPERATIVELY ACROSS MANY
DIFFERENT ICs RATHER THAN
HAVING THAT BE DRIVEN WITHIN AN
INDIVIDUAL OR EVEN WITH A COUPLE
OF ICs.
FOR ME FROM A BIOLOGICAL
PERSPECTIVE, CELLULAR SENESCENCE
AFFECTS SO MANY DIFFERENT END
POINTS AND SO MANY DIFFERENT
PIECE OF BIOMEDICAL RESEARCH
THAT I THINK THAT THAT PROVIDES
SOME STRONG SUPPORT TO IT BUT
I'D LIKE TO ASK IF THERE'S
ANYTHING ELSE YOU'D LIKE TO ADD
ON THAT PARTICULAR POINT.
>> I THINK I'D VERY MUCH BUILD
ON WHAT YOU SAID AND ALSO
DR. HODES IN THINKING ABOUT THIS
PROGRAM, YOU KNOW, IS THE
WORKING GROUP COMES FROM THE
DIFFERENT ICs AND IF IT
TRANSITION AND WE SAID OH, THIS
IS MOSTLY OF INTEREST TO AGE,
I'M NOT INSULTING MY NIA
COLLEAGUES BUT I'M SAYING WE'D
THEN LOSE THE PERSPECTIVE THAT
HAVING THIS AS A COMMON FUND
PROGRAM WITH THAT TRANSNIH
WORKING GROUP AND THAT NIH-WIDE
COLLABORATION BRINGING IN THE
EXPERTISE ACROSS THE DIFFERENT
AREAS AND THE REAL STATION OF
HOW TO THINK, PARTICULARLY IN
PHASE TWO WHERE THERE'S THIS
DISEASE FOCUS, HOW TO INTEGRATE
IT IN WITH THE SUBJECT MATTER
EXPERTS AND EXPERTISE WITHIN
AUTOIMMUNE CROSS THE NIH.
SO IT IS ONE OF THE THINGS THAT
WE ASK AND DR. HODES LAID OUT,
THIS TIEING IN TO THOSE FIVE
CRITERIA AND THE SYNERGISM AND
THE SORT OF APPLICABILITY ACROSS
NIH IS A CRITICAL THING THAT WE
ASK IN CONSIDERING THE
CONTINUATION OF A PROGRAM WITHIN
COMMON FUND AS OPPOSED TO MAKING
IT SOMETHING THAT WOULD BE
TRANSITIONED INTO AN IC.
BECAUSE WE HAVE COMMON FUND
PROGRAMS THAT HAVE DONE BOTH.
IN THIS CASE, I THINK IT'S
REALLY THE APPLICABILITY OF THIS
TO -- ACTIVITY ACROSS THE ENTIRE
NIH MISSION THAT MAKES IT
BENEFIT FROM THAT NIH-WIDE
COORDINATION AND PERSPECTIVE
THAT COMES THROUGH COMMON FUND
PROGRAMS.
>> THANK YOU, CAROLYN.
I'LL ASK JENNIFER IF YOUR IF HES
HAVE ALL BEEN A -- YOUR
QUESTIONS HAVE ALL BEEN
ADDRESSED?
>> YES, THEY HAVE.
>> FAN T FANTASTIC.
IF YOU HAVE QUESTIONS, PLEASE
RAISE YOUR HAND AND YOU'LL BE
RECOGNIZE AND ASKED TO UNMUTE
YOURSELF.
IF NOT, WE WILL PROCEED TO A
VOTE.
FRANZISKA, GO AHEAD.
>> GREAT, THANK YOU.
I WILL BE CALLING FOR THE VOTE
AND THAT WILL READ, MAY I HAVE A
MOTION FOR APPROVAL OF THE
COMMON FUND CONCEPT CLEARANCE
STAGE TWO ENTITLED CELLULAR
SENESCENCE NETWORK, SENNET
PROGRAM.
IF YOU SUPPORT THE MOTION,
PLEASE SAY SO MOVED.
I SEE THE SECOND.
IS THERE ANY ADDITIONAL
DISCUSSION AT THIS POINT?
I SEE ONE HAND.
IS THAT FROM BEFORE?
MONICA.
OH, YOU'RE MUTED.
>> I MEANT YEA, I DIDN'T MEAN
NAY.
SORRY.
>> THANK YOU.
SO IF THERE IS NO MORE
DISCUSSION, WE'LL DO THE SAME
PROCEDURE OVER.
I TURN IT OVER TO CHRIS TEAL NAR
THE HAND RAISING VOTE.
>> THANK YOU, DR. GRIEDER.
AS A REMINDER ONLY
COUNCILMEMBERS SHOULD
PARTICIPATE IN THIS VOTE.
THIS IS A VOTE ON THE MOTION FOR
APPROVAL OF THE PRESENTED
CONCEPT CLEARANCE.
PLEASE RAISE YOUR HAND TO VOTE
AYE.
I SEE 13 HANDS, I SEE 14 HANDS.
PLEASE RAISE YOUR HAND TO VOTE
AYE.
THANK YOU.
I SEE 14 HANDS.
PLEASE LOWER YOUR HANDS AND
WE'LL MOVE TO THE NEXT VOTE.
PLEASE RAISE YOUR HAND TO VOTE
NAY.
THANK YOU.
I SEE ONE HAND TO VOTE NAY.
PLEASE LOWER YOUR HANDS.
THROUGH.
PLEASE RAISE YOUR HANDS TO VOTE
ABSTENTION.
THANK YOU.
I SEE ONE HAND.
PLEASE LOWER YOUR HAND.
THIS CONCLUDES THE VOTE.
THE MOTION AS STATED HAS PASSED.
>> GREAT, THANK YOU, CHRISTINA.
BACK TO YOU, NICOLE.
>> GREAT.
THANK YOU SO MUCH, EVERYONE.
OKAY.
MOVE SOMETHING TO THE LAST CONCF
THE MEETING.
THIS IS ALSO FROM THE OFFICE OF
STRATEGIC COORDINATION AND
PRESENTED BY MIKE CHIANG, THE
NEI, THE NATIONAL EYE INSTITUTE
DIRECTOR, AND BRUCE TROMBERG,
DIRECTOR OF THE NA NATIONAL
INSTITUTE OF BIOMEDICAL IMAGING
AND BIOENGINEERING.
SO THE PRESENTATION FOR THIS NEW
CONCEPT, PUTTING MYSELF OUT ON A
LIMB HERE, I'M PRETTY SURE THIS
IS RIGHT, PRECISION MEDICINE
WITH AI, INTEGRATING IMAGING
WITH MULTIMODAL DATA, SO THE
PRIMED AI PROGRAM, WILL BE
FOLLOWED BY COMMENTS FROM THE
TWO ASSIGNED COUNCILMEMBER
DISCUSSANTS, DR. KEVIN JOHNSON
AND DR. LINDA CHANG.
SO MICHAEL, BRUCE, OVER TO YOU.
>> LET'S TAKE A FIVE-MINUTE
BREAK AND WE WILL RECONVENE AT
3:33.
>> THANK YOU, EVERYONE, FOR
ADHERING TO THE FIVE-MINUTE
RESTRICTION FOR OUR BREAK, AND
SO NOW WE WILL JUMP IN TO OUR
LAST CONCEPT PRESENTATION, SO
MICHAEL, BRUCE, I'M GOING TO
TURN IT OVER TO YOU.
>> THANK YOU.
THANKS TO ALL OF YOU FOR
STICKING WITH US THROUGH THIS
PRESENTATION OR AT LEAST
STARTING THE PRESENTATION.
SO I'M THE DIRECTOR OF NIBIB,
THE IMAGING AND ENGINEERING
INSTITUTE, AND MIKE, I DON'T
KNOW IF YOU'RE ON -- DID YOU
FLASH YOUR CAMERA ON?
>> I AM ON.
MICHAEL CHIANG, DIRECTOR OF
NATIONAL EYE INSTITUTE, EXCITED
TO BE HERE.
>> MIKE IS DIRECTOR OF THE
ORIGINAL IMAGING INSTITUTE, THE
VERY FIRST ONE, AND WE CONTINUE
TO SEE THAT MOVE FORWARD.
SO WE'LL BE PRESENTING TOGETHER.
THIS IS A NEW CONCEPT, AND
ALTHOUGH ONE THAT CERTAINLY HAS
A LOT OF DISCUSSION AND
POPULARITY IN OUR COMMUNITY MORE
BROADLY.
SO LET'S GO TO THE NEXT SLIDE.
SO WE'LL BE PRESENTING FOUR
BASIC IS UP SUBRAMANIAM GOALS.
SUB GOALS, WE'LLGIVE YOU AN IDEF
THESE AND THE ORIGIN BREAKING
THE STRUCTURE DOWN.
WE ANTICIPATE IN THE FIVE YEARS
FUNDING ABOUT 90 AWARDS,
SPANNING MULTIPLE AWARD TYPES,
REFLECTIVE OF THE KIND OF
COMMUNITY EFFORT THAT WE REALLY
NEED TO ENCOURAGE AND BUILD IN
ORDER TO HAVE A SUCCESSFUL
CONCEPT.
SO MIKE AND I ARE REPRESENTING A
REALLY AMAZING GROUP OF PEOPLE.
THIS IS ABOUT 50 DIFFERENT
INDIVIDUALS CONTRIBUTING TO THIS
ENTIRE CONCEPT.
VERY ENTHUSIASTICALLY CO-CHAIRS,
SUSAN GREGURICK, RICHARD HODES,
AND WALTER KOROSHETZ WHO LEADS
NINDS.
WE'VE WORKED REALLY CLOSELY WITH
COMMON FUND STAFF, CHRIS,
SAHANA, CAITLYN AND DAVID.
OUR MAIN PROGRAM COORDINATORS,
SANGEETA, MIKE AND KRIS FROM
NIBIB.
WE'VE ALSO COORDINATED OF COURSE
WITH GRANTS MANAGEMENT AND CSR,
AND OUR WORKING GROUP PROGRAM
DIRECTORS, THERE ARE ABOUT 35 OF
THEM FROM 19 DIFFERENT ICs,
INSTITUTES, CENTERS AND OFFICES,
REALLY REFLECTIVE OF THE BROAD
APPEAL OF THIS INITIATIVE THAT
REALLY CUTS ACROSS SO MANY
DIFFERENT INSTITUTES AND
PROGRAMS.
SO THIS IS THE IMENTAGING
REPRESENTATION, KIND OF THE
ICONOGRAPHY OF THE ENTIRE
CONCEPT, AND OF COURSE WE'LL GET
INTO DETAILS IN EVERY U ONE OF
THESE COMPONENTS.
BUT ALL OF YOU WHO ARE FAMILIAR
WITH MEDICAL IMAGING, RADIOLOGIC
IMAGING, FIRST OF ALL, THERE'S
BEEN ENORMOUS ACTIVITY IN THE
DEVELOPMENT OF DATA SCIENCE
APPROACHES, ARTIFICIAL
INTELLIGENCE BASED TECHNIQUES IN
RADIOLOGY, SO OF THE MORE THAN A
THOUSAND OR SO ALGORITHMS THAT
THE FDA HAS AUTHORIZED IN TERMS
OF SOFTWARE, MEDICAL DEVICE,
USING AI AND MACHINE LEARNING,
ABOUT 75% OF THEM ARE IN
RADIOLOGY.
PATHOLOGY ALSO PRESENTS UNIQUE
OPPORTUNITIES FOR UTE EUSING
DATA SCIENCES FOR EXTRACTING
DEEPER INFORMATION CONTENT,
CAMERA IMAGES, WE SAY CAMERA BUT
ANY WAY OR FORM OF RAS TORE
SCANNING BY SENSOR OR SINGLE
POINT IMAGING DETECTOR TO GET
OPTICAL IMAGING, ENDOSCOPY, OP
THALAMIC SCANNING, DERMATOLOGIC
SCANNING, VARIETY OF DIFFERENT
APPROACHES THERE.
ALL OF THESE METHODS HAVE
ENORMOUS INFORMATION CONTENT.
SO IF YOU LOOK AT WHAT IS
TYPICALLY DELIVERED IN
HEALTHCARE AT CLINICAL
IMPRESSION FROM A RADIOLOGY
REPORT MAY CONTAIN A FEW
SENTENCES OF INFORMATION,
KILOBITS OF INFORMATION CONTENT
BUT OUR RESEARCH COMMUNITIES IN
EACH OF THESE IMAGING SECTORS
HAVE REALLY BEEN PUSHING THE
ENVELOPE TO EXTRACT WHAT IS
CLOSER TO THE TRUE DATA SIZE OF
EACH OF THESE IMAGING
APPROACHES, MEGABYTES,
GIGABYTES, TERABYTES OF
INFORMATION CONTENT, THERE'S
ENORMOUS ACTIVITY BOTH WITH THE
DEVELOPMENT OF ADVANCED DATA
SCIENCE APPROACHES AND THE
COMBINATION OF THESE METHODS
WITH CLINICAL APPROACHES AND
CLINICAL INFORMATION CONTENT
FROM LAB TEST RESULTS, FROM
CLINICAL DATA, AND IMPRESSION
REPORTS THAT REALLY POTENTIALLY
CAN DRAMATICALLY INCREASE THE
POWER IN THE INFORMATION CONTENT
OF ALL OUR IMAGING STUDIES.
BUT IMAGING TENDS TO BE SOMEWHAT
SILOED.
CLINICIANS WHO ARE GUIDING
PATIENT MANAGEMENT DON'T REALLY
UNDERSTAND ALL THE DIFFERENT
TECHNOLOGIES AND APPROACHES THAT
ARE REALLY BEAUTIFULLY BEING
DEVELOPED BY THE RESEARCH
COMMUNITY AND COULD POTENTIALLY
INFORM HOW TO OPTIMIZE PRECISION
MEDICINE FOR PATIENTS.
SO THIS IS THE ESSENTIAL
CHALLENGE FOR US.
THERE'S ENORMOUS AMOUNT OF
RESEARCH THAT WE SUPPORT AT THE
NIH, AND MANY OF US HAVE BEEN
DEEPLY INVOLVED IN FOR SEVERAL
DECADES.
THIS SPANS FROM RADIOMICS TO
TECHNIQUES FOR EXTRACTING UNIQUE
INFORMATION CONTENT THAT
PREVIOUSLY WAS INVISIBLE IN
MEDICAL IMAGES BUT WITH NEW
TECHNIQUES FOR BACKGROUND
SUPPRESSION, ENHANCEMENT OF
CONTRAST TO BACKGROUND, AND
CORRELATING WHAT WE SEE IN AN
IMAGE WITH ALL OF THE LAB
RESULTS AND CLINICAL DATA, THIS
IS A VERY, VERY VIBRANT FIELD OF
ACTIVITY.
BUT IT IS VERY FAR OFF FROM WHAT
WE'RE SEEING IN CLINICAL
PRACTICE.
SO OUR FUNDAMENTAL CHALLENGE IS
TO TAKE THIS MULTIMODAL DATA AND
INTEGRATE IT IN SUCH A WAY AS TO
IMPROVE PROGNOSIS AND DIAGNOSIS
FOR PATIENTS, DO IT IN A
VALIDATED WAY, VERIFY ALGORITHMS
THAT ARE BEING DEVELOPED, AND
DISTRIBUTE THEM FAIRLY AND
EQUITABLY FOR ALL PATIENTS WHO
WILL BENEFIT FROM THEM.
SO THAT'S FAR OFF FROM WHERE WE
ARE IN THE RESEARCH COMMUNITY,
BUT WE BELIEVE THIS IS A UNIQUE
MOMENT WHERE WE CAN LEVERAGE
SIGNIFICANT ADVANCES IN MANY OF
THE DIFFERENT TECHNOLOGIES THAT
GO INTO THIS CONCEPT FROM THE
IMAGING METHODS THEMSELVES TO
THE DATA SCIENCE AND
COMPUTATIONAL METHODS FOR
EXTRACTING INFORMATION CONTENT,
TO MULTIMODAL TYPES OF LEARNING
STRATEGIES THAT INTEGRATE VERY
BEAUTIFUL IMAGING TYPES OF
APPROACHES WITH OUR CLINICAL
INFORMATION CONTENT AND LAB TEST
RESULTS, WHICH TEND TO BE LOWER
BIT RATE INFORMATION, BUT
COMBINED WITH IMAGING WHERE WE
COULD POTENTIALLY EXTRACT VERY,
VERY HIGH MEGABYTE, GIGABYTE
INFORMATION CONTENT, WE COULD DO
THINGS, I THINK, THAT ARE VERY
UNUSUAL AND POWERFUL AND
TRANSFORMATIVE FOR PATIENTS.
ONE OF THE THINGS THATTING WE TR
ABOUT ALL THE TIME WITH COMMON
FUND PROGRAMS IS ARE WE DOING
THIS ALREADY.
THE ANSWER IS KIND OF YES AND
NO.
SO THIS SLIDE, THE TOP PLOT
SHOWS THE EXPANSIVE GROWTH OF AI
AND ML, DEEP LEARNING TECHNIQUES
ACROSS THE NIH, MORE THAN 6,000
TYPE 1 GRANTS INTEGRATED OVER
THAT FIVE-YEAR INTERVAL FROM
2019 TO 2023, BUT ONCE YOU START
TO NARROW THIS DOWN AND LOOK AT
THIS IN COMBINATION WITH
CLINICAL IMAGING, WE REDUCE THAT
ONLY TO ABOUT 2,000 TYPE
1 GRANTS INTEGRATED OVER THAT
ENTIRE FIVE YEARS.
AND THEN IF YOU LOOK AT HOW
THESE WILL COME TOGETHER WITH
PRECISION MEDICINE, IT'S EVEN
FEWER.
THE GRANT TOTAL IS IN THE
HUNDREDS.
SO THIS SAYS A COUPLE OF THINGS.
THERE IS A SIGNIFICANT AMOUNT OF
INTEREST AND INVESTMENT IN THE
FUNDAMENTAL TECHNIQUES THAT ARE
DRIVING AI, MACHINE LEARNING AND
DEEP LEARNING, BUT THEY'RE KIND
OF SILOED FROM ONE ANOTHER.
SO WE HAVE INFRASTRUCTURE AND
CAPACITY ALL AROUND THE COUNTRY
IN THESE CORE TECHNICAL AREAS,
BUT WE DON'T HAVE A COHESIVE
STRUCTURE TO BRING THEM ALL
TOGETHER.
SO THIS SUGGESTS TO US THERE ARE
KEY OPPORTUNITIES HERE FOR
FEDERAL AND NON-FEDERAL
PARTNERSHIPS THAT COULD MAKE
THIS INITIATIVE QUITE POWERFUL.
DOLLARS IN OUR NEXT STEP OF
EVALUATING IS THIS SOMETHING
UNIQUE, IS THIS A FIGUREMENT OF
OUR IMAGINATION, WE THINK IT'S
IMPORTANT SO THEREFORE WE WANT
TO MOVE IT FORWARD.
WE DID A PUBLIC RFI AND HEALTH A
STROO STRATEGIC PLANNING
WORKSHOP MARCH 11TH AND 12TH.
BOTH OF THESE PROVIDED ENORMOUS
RESPONSE AND INFORMATION
CONTENT.
OVER A THOUSAND PARTICIPANTS
ENGAGED.
WE HADN'T ANNOUNCED THE
INITIATIVE AT ALL, JUST THE
IDEAS BEHIND THE INITIATIVE,
WHAT WERE THESE KEY IDEAS.
BASED ON THE PUBLIC RFI, OUR
TEAM REALLY EXTRACTED FOUR MAJOR
THEMES.
IMAGING AND MULTIMODAL
INTEGRATION, AI ALGORITHM AND
TOOL DEVELOPMENT, CLINICAL
IMPLEMENTATION, AND BUILDING
TRUST AND COORDINATION.
AND THESE ARE THE FOUR
FOUNDATIONAL ELEMENTS OF OUR
PROGRAM, AND IF WE GO TO THE
NEXT SLIDE, MIKE WILL TAKE IT
FROM HERE AND EXPAND INTO ALL OF
THOSE ELEMENTS OF THE PROGRAM.
>> BRUCE, THANK YOU.
SO BASICALLY THIS SLIDE TALKS
ABOUT BASICALLY THESE UNMET
NEEDS THAT FOLLOW NATURALLY FROM
WHAT BRUCE JUST TALKED ABOUT.
I'M JUST GOING TO TAKE YOU
THROUGH THESE BULLET POINTS
QUICKLY.
IF YOU LOOK AT THE FIRST BULLET
POINT AND THE THIRD BULLET
POINT, THEY BASICALLY TALK ABOUT
AN UNMET NEED GOING FROM SINGLE
MODALITY DATA TO MULTI-MODALITY
DATA, AND LINKING THOSE DATA
ACROSS THE DIFFERENT SCALES FROM
MOLECULES UP TO PATIENTS TO
POPULATIONS.
THE SECOND BULLET POINT HERE
TALKS ABOUT ADDRESSING THESE
UNMET NEEDS AND GAPS INVOLVING,
FOR EXAMPLE, INTEROPERABILITY
AND HARMONIZATION THAT ARE GOING
TO MOVE US TOWARD ADVANCING
AI-DRIVEN PRECISION MEDICINE FOR
ALL AMERICANS, AND THE BOTTOM
TWO BULLET POINTS TALK ABOUT
REAL WORLD IMPLEMENTATION,
GETTING THESE AI TOOLS INTO
CLINICAL DECISION SUPPORT TOOLS
THAT COULD BE USED BY CLINICIANS
USING ELECTRONIC HEALTH RECORDS,
AND BUILDING ALL THOSE
RELATIONSHIPS AMONG THE
STAKEHOLDERS.
PATIENT, CLINICIANS, DATA
SCIENTISTS.
THAT ARE GOING TO BE NEEDED TO
REALLY MOVE THE FIELD FORWARD.
SO IF YOU CAN GO TO THE NEXT
SLIDE, PLEASE.
IN THIS SLIDE, WHAT WE REALLY
TALK ABOUT IS MOVING FROM BLUE
SKY TO MAKE IT A LITTLE BIT MORE
TANGIBLE.
SO HERE, WE DESCRIBE A SERIES OF
NOFOs THAT ARE INTENDED TO
ADDRESS FOUR ITERATIVE SUBGOALS.
AND THESE GOALS ARE COLOR-CODED.
SO GOING FROM LEFT TO RIGHT, AT
THE UPPER LEFT, THERE IS
INTEGRATION OF IMAGE DATA
TOGETHER WITH MULTIMODAL DATA.
SO THAT'S -- THE MULTIMODAL DATA
COULD BE CLINICAL DATA, GENETIC
DATA, MULTI-OMIC DATA, SO THEN
UP IN THE BLUE, ON THE UPPER
RIGHT IS BUILDING THOSE AI
ALGORITHMS AND TOOLS.
AND THOSE TOOLS COULD BE USED TO
DO THINGS LIKE CLINICAL
DIAGNOSIS, PATIENT MANAGEMENT,
PREDICTION OF FUTURE DISEASE.
SO THEN GOING DOWN TO THE LOWER
LEFT, CLINICAL IMPLEMENTATION,
THIS IS ALL THAT REAL WORLD
IMPLEMENTATION THAT WE TALKED
ABOUT, AND IN THE GREEN AT THE
BOTTOM RIGHT IS TRUST, AND
YOU'LL SEE ON THE DIAGRAM THE
TRUST ENCOMPASSES EVERYTHING.
AND WHAT DO WE MEAN BY THAT?
PROGRAM COHESION, ADAPTABILITY,
SCIENTIFIC VALIDATION AND RIGOR,
AND TRANSPARENCY.
SO JUST KEEP IN MIND THAT THESE
CONCEPTS DON'T WORK IN ISOLATION
FROM ONE ANOTHER.
LIKE FOR EXAMPLE, THERE'S NOT
GOING TO BE A YELLOW NOFO AND A
BLUE NOFO.
IN REALITY, THESE SUBCONCEPT ARE
PRETTY HEAVILY INTERRELATED, AND
SO WHAT I WANT TO DO, IF YOU CAN
GO TO THE NEXT SLIDE, WHAT WE'RE
DOING IS TAKING ALL THESE
CIRCLES AND BASICALLY FLATTENING
THEM, AND THIS IS GOING TO BE A
LITTLE BIT EVEN MORE TANGIBLE
ABOUT THE ACTUAL NOFOs.
SAME COLOR CODING IS ON THE
PREVIOUS SLIDE, AND GOING FROM
TOP TO BOTTOM, THE DATA
INTEGRATION IS IN YELLOW, AND
HERE THERE WOULD BE THREE SETS
OF NOFOs THAT WE WOULD REALLY
PROPOSE.
ONE IS WHAT WE'RE CALLING A
PLAYBOOK OF STANDARDIZED FRAME
WORKS.
AND HERE, THE WAY THIS WOULD
REALLY WORK IS THAT THESE
PLAYBOOKS WOULD DESCRIBE
ESSENTIALLY BEST PRACTICES FOR
BUILDING MULTIMODAL AI SYSTEMS
FOR DIFFERENT USE CASES, SO
INVESTIGATORS COULD USE THIS
PLAYBOOK TO GET HELP WITH A
RANGE OF CHALLENGES FROM BEST
PRACTICES FOR VALIDATION OF AI
ALGORITHMS TO IDENTIFYING
INDICATIONS FOR USE FOR CLINICAL
IMPLEMENTATION TO NAVIGATING
REGULATORY HURDLES.
SO THE NEXT ROW HERE IS
ACADEMIC-INDUSTRIAL
PARTNERSHIPS.
AND THAT REALLY GET INTO WHAT
BRUCE WAS TALKING ABOUT, ABOUT
BUILDING COLLABORATIONS AND
GETTING STUFF INTO THE REAL
WORLD.
AND THE LAST OF THESE IS A SET
OF NOFOs TO DEVELOP MODULAR
SOFTWARE TOOLS.
SO THERE WOULD BE A LOT OF
TOOLS, AND WE WOULD INTEND TO
FUND ABOUT 40 PROJECTS IN THIS
AREA, AND SOME OF THESE TOOLS
WOULD BE TO -- SO THE IDEA IS
THAT THEY WOULD BE RE-USED BY A
LOT OF DIFFERENT GROUPS AROUND
THE COUNTRY.
THEY COULD BE USED FOR
MULTIMODAL DATA INTEGRATION, FOR
EVALUATING THE ROBUSTNESS OF
MODELS OR TO BASICALLY DEVELOP
BETTER USER INTERFACE DESIGN
WIDGETS.
SO A LOT OF THESE MODULAR
SOFTWARE TOOLS.
THE RED HERE IS THOSE CLINICAL
IMPLEMENTATION AND TESTING
PHASE.
AND HERE, THERE'S A SINGLE NOFO
THAT'S CALLED THE MODEL TO
CLINIC NOFO THAT'S THE SINGLE
BIGGEST ONE IN THIS PROJECT.
AND I'M GOING TO TALK ABOUT IN
THE NEXT SLIDE, SO IF YOU COULD
PUSH ONCE MORE.
THE LAST OF THESE IS THAT
THERE'S THE TRUST SET OF
NOFOs, AND YOU NOTICE HERE
AGAIN THAT IT ENCOMPASSES ALL
THE OTHER PROJECTS, AND HERE WE
ENVISION THIS AS A SERIES OF
THREE CENTERS BASICALLY.
ONE IS A VALIDATION CENTER FOR
DOING VERIFICATION AND
VALIDATION INDEPENDENTLY OF THE
TOOLS THAT ARE DEVELOPED THROUGH
PRIMED AI.
THE NEXT SET IN THE MIDDLE IS A
LOGISTICS CENTER, AND THAT'S
BASICALLY GOING TO DO ALL THE
PROGRAM ADMINISTRATION AND
TEAMING SUPPORT AND ENGAGEMENT
WITH STAKEHOLDER COMMUNITIES
THAT'S GOING TO BE SO IMPORTANT
FOR A PROJECT LIKE THIS.
AND LASTLY, ON THE BOTTOM RIGHT
OF THE SLIDE IS COMMUNICATION
CURRICULA NOFOs.
AND THESE ARE BASICALLY GOING TO
BE NOFOs TO DEVELOP STRATEGIES
TO BUILD COMMUNICATION AND TRUST
AMONG DATA SCIENTISTS,
CLINICIANS AND PATIENTS.
AGAIN, WE THINK THAT'S REALLY
GOING TO BE IMPORTANT FOR A
PROJECT LIKE THIS.
IF YOU CAN GO TO THE NEXT SLIDE,
PLEASE.
AND THIS SLIDE, WHAT WE REALLY
GIVE IS MORE DETAILS ABOUT HOW
THIS MODEL TO CLINIC NOFO WOULD
LOOK.
SO AGAIN, THIS IS THE SINGLE
BIGGEST SET OF NOFOs THAT
WE'RE PROPOSING IN PRIMED-AI.
THERE WOULD BE ABOUT 10 OF THESE
WE WOULD FUND AND THE TOTAL
INVESTMENT WOULD BE $50 MILLION
OVER FIVE YEARS.
SO WE ENVISION THIS OCCURRING IN
TWO PHASES.
PHASE ONE IS DEVELOPING THE
TOOLS AND PHASE TWO IS TESTING,
WHAT WE CALL ANCILLARY CLINICAL
TESTING.
SO AGAIN IT INTEGRATES ALL THE
YELLOWS, THE BLUES, THE GREENS
AND REDS FROM THE PREVIOUS
SLIDES.
ARE THE DATA CAN COME FROM
RETROSPECTIVE CLINICAL TRIALS,
AND WE WOULD DEVELOP TOOLS TO
INTEGRATE THOSE DATA AND MAKE
THEM INTEROPERABLE.
AND THEN MOVING TO THE BLUE, WE
WOULD BUILD AI ALGORITHMS TO
SOLVE DEFINED CLINICAL PROBLEMS.
AND OUR ANTICIPATE IS THAT WE
WOULD HAVE ESSENTIALLY A
GO/NO-GO FUNNEL, BAS BASE BENCHS
BASED ON PRELIMINARY TESTING
THAT WOULD PASS TO PHASE TWO
WHICH IS ANCILLARY CLINICAL
TESTING.
THE WAY THAT THIS WOULD WORK IS
THE RED BARS HERE WE WOULD
IDENTIFY MECHANISMS TO
PERFORMANCE LARRY TESTING AND
THEY COULD BE TESTED IN ACADEMIC
MEDICAL CENTERS, IN COMMUNITY
HOSPITALS, OR THEY COULD BE
USED, THEY COULD BE APPLIED, FOR
EXAMPLE, FOR EXISTING INDUSTRY
FUNDED CLINICAL TRIALS, WHERE WE
WOULD DEFINE NEW SECONDARY
OUTCOME MEASURES THAT PRIMED-AI
ALGORITHMS COULD APPLY TO.
SO WHAT WE'RE REALLY TRYING TO
DO IS TO CREATE OPPORTUNITIES TO
GET THIS INTO THE REAL WORLD,
AND AT THE BOTTOM IN THE GREEN,
THERE WOULD BE AN INDEPENDENT
MODEL TESTING THAT WOULD BE DONE
IN COORDINATION WITH THAT
VALIDATION CENTER, ONE OF THOSE
GREEN AREAS.
SO I REALLY WANT TO EMPHASIZE
THAT I HOPE IT COMES ACROSS THAT
THE DESIGN OF THIS IS REALLY
MEANT TO RESPECT THE FACT THAT
AI IS REALLY RAPIDLY EVOLVING,
IT A DYNAMIC FIELD, AND WE WANT
TO MAKE SURE THAT THIS ECOSYSTEM
OF PRIMED-AI PROJECTS LEAVES US
WITH THE FLEXIBILITY TO EVOLVE
THIS CONCEPT AS THE FIELD
EVOLVES.
WE REALLY WANT TO BE AGILE,
NIMBLE AND GIVE US THE
FLEXIBILITY TO PIVOT AS THE
FIELD CHANGES.
THIS NEXT SLIDE BASICALLY
SUMMARIZES THE BUDGET WE'RE
TALKING ABOUT.
SO IT'S $120 MILLION TOTAL
SPREAD OVER FIVE YEARS.
AND ALL THE NOFOs ARE DEFINED
THAT WE SHOWED ON THE PREVIOUS
SLIDES.
STARTING FROM THE PLAYBOOK,
YOU'LL NOTICE THE MODEL TO
CLINIC NOFO IS THE BIGGEST ONE,
10 AWARDS, $51 MILLION.
DOWN AT THE BOTTOM ARE THOSE
VALIDATION CENTER, LOGISTICS
CRITERIA.
THESE ARE THE DELIVERABLES AND
WE'RE REALLY EXCITED ABOUT THIS.
BEST PRACTICES FOR AI-BASED
PRECISION MEDICINE THROUGH
INTEGRATING IMAGING AND
MULTIMODAL DATA.
DEVELOPING A SET OF INNOVATIVE
AND RELIABLE TOOLS, AND LASTLY
AT THE BOTTOM, AND REALLY
IMPORTANTLY, DEVELOPING A SERIES
OF DURABLE RELATIONSHIPS THAT
ARE GOING TO SUSTAIN THE FIELD
AND HOPEFULLY EXPAND IT IN THE
FUTURE.
IF YOU GO TO THE LAST -- THE
NEXT SLIDE WHICH IS OUR LAST
SLIDE, THESE ARE THE TAKE-HOME
POINTS THAT BRUCE STARTED OUT BY
SAYING THAT WE'RE REALLY EXCITED
ABOUT THIS PROJECT, AND I WOULD
JUST FINISH BY SAYING THAT.
WE'VE GOT A LOT OF PEOPLE AT NIH
AND DIFFERENT INSTITUTES
INVOLVED, REALLY EXCITED ABOUT
THIS AS A COMMON FUND CONCEPT.
AI SUPPORTED TRANSLATIONAL
IMPACT FOR PATIENTS, TRYING TO
ADVANCE CULTURE CHANGE IN
CLINICAL PRACTICE BY ENABLING
PRECISION MEDICINE STRATEGIES AT
A LARGE SCALE AND GETTING INPUT
FROM ALL THE STAKEHOLDERS, AND
BASICALLY EXCEL RAIGHT THE USE
OF MULTI-SCALE DIGITAL
BIOMARKERS.
SO WITH THAT, I'M GOING TO STOP.
THANK YOU FOR YOUR ATTENTION,
AND NICOLE AND FRANZISKA, MAY WE
TURN TO YOU TO LEAD THIS
DISCUSSION?
>> THANK YOU BOTH VERY MUCH.
SO I WILL PASS IT OVER TO
DR. JOHNSON.
WOULD YOU PLEASE SHARE ANY
COMMENTS WITH THE COUNCIL?
>> I WOULD BE PLEASED TO.
FIRST OF ALL, I WANT TO APPLAUD
YOU BOTH FOR DEVELOPING THIS
CONCEPT AND REALLY THINKING
ABOUT IT AS AN ECOSYSTEM FOR THE
DEVELOPMENT AND ADOPTION OF
INNOVATIVE AI-BASED TOOLS.
THE GAP THAT WAS IDENTIFIED IN
THE RESEARCH RELATED TO
INTEGRATING IMAGING AND
MULTIMODAL DATA IS DEFINITELY
ONE THAT RESONATES WITH THE
COMMUNITY AT LARGE AS WELL AS IN
THE BRIDGE2AI AND INVESTIGATOR
COMMUNITY.
I DID NOTICE THAT IN THE GAP,
THERE'S A COUPLE THINGS YOU
DIDN'T DISCUSS.
I'M GOING TO COME BACK TO THOSE.
MY PRESENTATION IS GOING TO BE A
LITTLE BIT SCATTERED BECAUSE IT
TURNS OUT THAT THE SLIDES NEEDED
TO BE TALKED THROUGH, NOT SHOWN,
AS I THINK YOU PROBABLY KNOW.
AND SO NOW THAT I'VE HEARD IT, I
WROTE SOME NOTES THAT I WANTED
TO MAKE SURE I INCLUDED.
FIRST OF ALL, THE IDEA OF THE
FOUR SUBGOALS THAT ARE
SUMMARIZED BY THE TEAM WERE
EXACTLY THE HIGH LEVEL ASPECTS
THAT WOULD BE NEEDED TO HAVE
TRANSLATION AND IMPACT FROM
THINGS LIKE PRECISION MEDICINE
USING AI.
I WOULD NOTE, THOUGH, THAT EVERY
SINGLE ONE OF THE WORDS THAT'S
BOLDED IS FRANKLY UP FOR DEBATE
IN TERMS OF ITS OVERALL UTILITY.
SO I THINK IT GOING TO BE
IMPORTANT TO ASK THOSE
QUESTIONS, IN MY OPINION,
FEDERATED LEARN WILLING.
WHILE FEDERATED LEARNING HAS A
ROLE IN PRIVACY IT ALSO HAS THE
OPPORTUNITY TO STIFLE INNOVATION
AS WE'VE LEARNED EVEN FROM
THINGS LIKE ODYSSEY.
SO YOU GUYS KNOW THAT, MANY OF
THE WORDS THAT YOU'LL SEE IN THE
ORIGINAL CONCEPT PROBABLY SHOULD
BE DISCUSSED AS INDIVIDUAL IDEAS
AND I'M SURE THEY WILL BE AS
THIS CONCEPT KIND OF EVOLVES A
BIT.
THE OTHER THING IS, I DIDN'T
QUITE SEE ENOUGH ABOUT WHAT WAS
LEARNED FROM BRIDGE2AI.
I WENT THROUGH THE RFI, I SAW A
LITTLE BIT BUT I STILL REALIZE
THAT BRIRNLG TO AI IS ONGOING
BUT IT APPEARS THEY HAVE A LOT
OF LESSONS.
SOME OF THEM ARE IN HERE, AND
THEY HAVE BEEN ITTIVELY APPLIED
TO THIS PROPOSAL'S REQUIREMENTS,
BUT SOME OF THEM ARE NOT.
SO I JUST THOUGHT IT WOULD BE
USEFUL TO MAKE SURE THAT YOU'VE
EXPOSED THAT.
AND IF I MISSED SOMETHING, I
APOLOGIZE THERE.
IT SEEMS TO ME THAT THE
COMMUNICATION CURRICULA AND THE
LOGISTICS CENTER ARE REALLY
IMPORTANT ASPECTS OF THIS TRUST
DIMENSION.
AS I WAS LOOKING THROUGH THAT,
AND ALSO BEING VERY SORT OF
THOUGHTFULLY CONSIDERING WHAT
DR. BHATTACHARYA TOLD US TODAY
ABOUT THE BIG IDEAS IN DATA, I
WONDERED TO WHAT EXTENT THE
TRUST COMPONENTS NEED TO BE
THOUGHT OF AS SORT OF A
PUBLIC-PRIVATE PARTNERSHIP RIGHT
FROM THE VERY BEGINNING SO IN
FACT WE CAN GET INVOLVEMENT OF
STAKEHOLDERS WHO ARE LIKE LIKELY
TO HELP SCALE IN INDUSTRY AS
WELL AS IN ACADEMIA.
WITHOUT THAT, I WONDER WHETHER
EVEN THOUGH YOU'VE PUT A LOT OF
MONEY INTO THAT PARTICULAR SET
UP THREE PROGRAMS, I WONDER
WHETHER THAT'S EFFICIENT WITHOUT
HAVING SOMETHING THAT LOOKS MORE
LIKE A PUBLIC PRIVATE
PARTNERSHIP, ESPECIALLY GIVEN
THE WORK THAT'S GOING ON WITH AI
ASSURANCE LABS AND MANY OF THE
OTHER INITIATIVES, THEY'RE
INCLUDING SOME OF THE WORK THAT
THE FDA UNDER DR. CALIFF STARTED
THAT I'M SURE WILL CONTINUE.
I ALSO NOTE THERE ARE SOME
MULTIMODAL DATA NOT INCLUDED
THAT I WOULD PERSONALLY LOVE TO
SEE INCLUDED.
THERE'S VERY GOOD DATA NOW TO
SUGGEST THE USE OF UNSTRUCTURED
TEXT.
PERHAPS YOU INCLUDED IT BUT YOU
DIDN'T EXPLICITLY SAY IT.
I DIDN'T SEE ANYTHING ABOUT
AUDIO SIGNALS AND I DIDN'T SEE
ANYTHING ABOUT VIDEO.
AND I THINK ALL OF THOSE ARE NOT
YET EXPLICITLY MENTIONED BUT ALL
OF THEM ARE BEING ACTIVELY
FUNDED BOTH AT THE NSF AND AT
THE NIH.
THE BUDGET SEEMS APPROPRIATE FOR
THE MOST PART.
I'M CURIOUS HOW MODULAR SOFTWARE
TOOLS AND R03s WILL PROGRESS
TO R01 LEVEL FUNDING, AND IN
PARTICULAR, AGAIN THINKING ABOUT
THE CURRENT NIH DIRECTOR'S
STRATEGY, THESE ARE BIG IDEAS
AND I'M WONDERING WHETHER
THERE'S DIFFERENT MECHANISMS
THAT COULD BE USED, WHETHER IT
BE ONE OF THE UH MECHANISMS OR
OTHER MECHANISMS IN ADDITION TO
SMALL GRANTS AND R01s.
IS THERE AN EXPECTATION OF
INSTITUTES THAT WILL PICK UP THE
FUNDING REQUIREMENTS TO ENABLE
THESE PROJECTS TO GET ALL THE
WAY TO CLINICAL TRIAL?
IN OTHER WORDS, IF I GET AN R03,
IS THERE ANYTHING YOU GUYS CAN
DO TO HELP GUARANTEE THAT
SUCCESSFUL PROJECTS GET ALL THE
WAY TO TRIAL WITHOUT HAVING TO
CONSTANTLY RECOMPETE PER SOME OF
WHAT WE HEARD ABOUT THIS MORNING
THAT I THINK YOU'VE HEARD ABOUT,
OR IS THIS IDEA THAT MODULAR
SOFTWARE TOOLS TO ADDRESS
CRITICAL GAPS IN THE DATA TO
MODELS PIPELINE, THAT THIS WOULD
NOT DEVELOP TECHNOLOGIES THAT
WOULD BE USEFUL AT THE BEDSIDE.
I BELIEVE FROM WHAT YOU'VE
PRESENTED THAT YOUR HOPE IS THAT
THINGS GO FROM SORT OF
FOUNDATIONAL AND BASIC SCIENCE
ALL THE WAY TO TRIAL THROUGH
THIS SET OF MECHANISMS, AND IF
SO, I THINK IT WOULD BE GREAT TO
MAKE SURE THE CONCEPT KIND OF
HAS EXPLICIT LANGUAGE ABOUT SOME
OF THE WAYS IN WHICH THAT
TRANSITION COULD BE IMPROVED FOR
GROUPS WHO ARE FUNDED THROUGH
THIS MECHANISM.
THOSE ARE MY MAIN COMMENTS.
I APPLAUD YOU ON A BIG IDEA, I
APPLAUD YOU ON COMPREHENSIVE
THINKING, AND I'M VERY EXCITED
TO SEE WHAT COMES OUT OF THIS.
I'M GOING TO BE VERY SUPPORTIVE.
>> THANK YOU.
MIKE, MAYBE I COULD START OFF.
SO TALK ABOUT HIGH BIT RATE
INFORMATION CONTENT AND THAT WE
NEED TO CAPTURE THAT AUDIO AND
PARSE IT OUT THROUGH GENERATIVE
TECHNIQUES.
I THINK YOU HIT SO MANY OF THE
TOPICS THAT WE'VE BEEN
DISCUSSING.
MAYBE, MIKE, I'LL JUST JUMP IN
ON MIKE AND I AND THE ENTIRE
GROUP, WE'RE IMPATIENT.
WE SEE THE BEAUTIFUL BASIC
RESEARCH, SUPPORT IT, IT'S
INCREDIBLE AND INSPIRATIONAL,
BUT WE ARE ALSO FEELING THE GAP
BETWEEN THE ACTUAL CLINICAL
PRACTICE OF APPLYING ALL OF WHAT
WE ARE FINDING IN IMAGING
STUDIES ACROSS THE BOARD TO
MANAGEMENT OF PATIENTS.
AND WHAT WE'VE DONE IN NIBIB, SO
WE'RE BRINGING THE CULTURES OF
OUR INSTITUTES AND THE
SKILLSETS, SO I'LL JUST ADDRESS
A COUPLE OF THESE ISSUES WITH
RESPECT TO THE TOOLS THAT WE CAN
PROVIDE TO ACCELERATE THE
VALIDATION OF ALGORITHMS AND TO
MOVE THEM THROUGH THE REGULATORY
PROCESS AS QUICKLY AS POSSIBLE.
SO IN MANY OF THE PROGRAMS THAT
WE SUPPORT AT NIBIB, WE HAVE A
VERY STRONG TRACK RECORD WITH
ENGAGING FDA RIGHT AT THE
BEGINNING AND WE'RE DOING THIS
IN ONE OF OUR SORT OF PREMIER
IMAGING DATABASES, THE MEDICAL
IMAGING DATA RESOURCE CENTER OR
MIDRC, WHICH INTEGRATES, IT
STARTED IN COVID AND IT'S
PIVOTED TO CANCER, AND IT'S A
KIND OF EXEMPLAR OF HOW WE CAN
DEVELOP ALGORITHMS, VALIDATE
THEM AND MOVE THEM QUICKLY
THROUGH THE REGULATORY PROCESS.
IT ALSO HAS EXPLORED TO SOME
EXTENT THE FEDERATED LEARNING
AND REALLY WE HAVE BEEN TRYING
TO IDENTIFY THE KEY ADVANTAGES
TO WHEN THINGS ARE BETTER MOVED
THROUGH FEDERATED PROCESSES
VERSUS DATABASES, THEY EACH HAVE
THEIR OWN CHALLENGES, BUT I
THINK WE'RE IN A UNIQUE POSITION
AT THE NIH WHERE I THINK WE CAN
RECOGNIZE AND IDENTIFY THE
ADVANTAGES AND THE DISADVANTAGES
AND PROVIDE SUPPORTIVE RESOURCES
FOR THE VALIDATION PROCESS AND
DEPENDENT VALIDATION AND THEN
BRINGING REGULATORY INTO THIS
MIX AS EARLY AS POSSIBLE SO THAT
WE CAN GET SOFTWARE AS MEDICAL
DEVICES APPROVED AND DISTRIBUTED
IN VERY TRUSTWORTHY KINDS OF
PLATFORMS.
SO I'LL STOP THERE BECAUSE YOU
COVERED SO MANY TOPICS, BUT YES,
WE DO HAVE A WHOLE BUNCH ACROSS
OUR INSTITUTES OF ONGOING
ANCILLARY SUPPORT IN ADDITION TO
PARTNERING WITH ANCILLARY
STUDIES BEING SUPPORTED ACROSS
THE NIH AND EVEN IN THE INDUSTRY
COMMUNITY THAT WOULD DRIVE THESE
PUBLIC-PRIVATE PARTNERSHIPS,
WORKING WITH INDUSTRY, WORKING
WITH FDA, THIS IS SOMETHING
VERY, VERY NORMAL FOR US AND
SOMETHING WE'LL TAP INTO VERY,
VERY DEEPLY BECAUSE ALL THESE
TOOLS ARE SO FAST MOVING AND
THERE'S SUCH A HIGH DEMAND AND
EXPECTATION OF GROWTH.
>
>> THANK YOU.
I'M HAPPY TO SHARE MY NOTE, BY
THE WAY.
>> YOU KNOW, KEVIN, I'M ONLY
GOING TO SAY A COUPLE THINGS IN
FOLLOW-UP TO WHAT BRUCE SAID,
WHICH IS TOTALLY APPRECIATE YOUR
COMMENTS, EVERY SINGLE ONE I
THINK RESONATED WITH ME.
I THINK ONE OF THE THINGS THAT
WE REALLY TRIED TO LEAVE
FLEXIBILITY IN THIS PROJECT
DESIGN IS TO EVOLVE THE PROJECT
AS THE FIELD EVOLVES.
WE DIDN'T SHOW A GANTT CHART
ABOUT THE DIFFERENT ENTRY POINTS
OF PROJECTS, BUT I'M HOPING
THAT -- YOU MENTIONED A COMMENT
ABOUT FEDERATED LEARNING IN
PARTICULAR, AND I THINK THERE'S
A GOOD CHANCE THAT THE FIELD
WILL LOOK DIFFERENT IN 2027
COMPARED TO WHAT IT LOOKS LIKE
RIGHT NOW, AND I HOPE THAT'S
GOING TO BE ACCOUNTED FOR IN OUR
PROJECT DESIGN.
KEVIN, YOU MENTIONED SOMETHING
ABOUT MULTIMODAL DATA AND THINGS
LIKE UNSTRUCTURED TEXT AND
VIDEO, AND I COMPLETELY AGREE.
YOU KNOW, JUST ON A PERSONAL
LEVEL, YOU AND I HAD A GREAT
CONVERSATION WHEN I WAS IN
PHILADELPHIA ABOUT A YEAR AGO,
SOME OF THE STUFF YOU'RE DOING
WITH THAT, AND I THINK THAT
THERE COULD BE A LOT OF -- I
AGREE I DON'T THINK THE ONLY
FORM OF DATA IS A DOCTOR OR
NURSE, YOU KNOW, CHECKING A
CHECK BOX OR USING A SO CALLED
DOT PHRASE, SO THAT WOULD BE
FABULOUS FOR SO MANY REASONS.
AND THERE ARE MANY THINGS THAT
I'VE PERSONALLY LEARNED FROM
BRIDGE2AI, BETTER WAYS TO DO
TEAMING, THE IMPORTANCE OF DATA,
THE IMPORTANCE OF STANDARDS AND
HOW EVERYBODY LIKES STANDARDS AS
LONG AS THEY'RE MY STANDARDS,
AND NOT USING SOMEBODY ELSE'S,
BUT ONE OF THE OTHER -- I
COMPLETELY AGREE WITH WHAT YOU
SAID ABOUT PUBLIC-PRIVATE
PARTNERSHIPS AND THAT'S THE
SPIRIT OF THESE, BUT AS BRUCE
SAID MAYBE WE NEED TO DO MORE
WITH ENGAGING FDA OR THE PAYORS
UP FRONT ABOUT THIS, BUT
ULTIMATELY ONE OF THE THINGS
THAT I PERSONALLY LEARNED WAS
THAT BRIDGE2AI IS NOT ENOUGH TO
ENHANCE THE FIELD.
SO HENCE WHY WE'RE HERE.
SO THANK YOU FOR ALL OF THAT,
AND I'LL STOP.
>> THANK YOU.
>> MIKE, IF I COULD JUST DO TWO
QUICK ADD-ONS TO THAT.
BRIDGE2AI, KEVIN YOU MENTIONED
THE AUDIO DATA WHICH WE'RE SO
EXCITED ABOUT AND IN FACT THAT
COULD BE MOST BEAUTIFUL STANDARD
AND EASILY ACCESSIBLE STANDARD
DATA FORMATS TO BE ABLE TO
INTEGRATE INTO THIS, WE'RE
CERTAINLY EXPECTING BIG THINGS
FROM THAT PROGRAM IN BRIDGE2AI.
IN TERMS OF THE R03 MECHANISM,
THIS IS A REALLY ONGOING
DISCUSSION AND DEBATE AMONGST
US.
R03, EVEN THOUGH IT'S A LOWER
BARRIER TO ENTRY, IS NOT
NECESSARILY A FAST TURNAROUND
TIME MECHANISM.
SO WE'RE EXPLORING APPROACHES
THAT WE PIONEERED IN NIBIB
THROUGH THE RAPID ACCELERATION
OF DIAGNOSTICS TECHNOLOGIES
PROGRAM, AND MIKE HAD MENTIONED
THE INNOVATION FUNNEL IN HIS
PRESENTATION PART, AND SO WE ARE
ABSOLUTELY CONSIDERING THAT AS A
WAY TO GET FUNDING TO DEVELOPERS
VERY, VERY QUICKLY, IN
UNPRECEDENTED TIME FRAMES, A
MATTER OF WEEKS, BUT ALSO BUILD
TEAMS AROUND THEM TO OPTIMIZE
THE CONCEPTS THAT ARE PROPOSED
AND PROVIDE THEM WITH ADDITIONAL
RESOURCES FOR DOING BETTER WITH
THE TECHNOLOGY, MOVING TO
MARKETS POTENTIALLY IF IT'S
BEING COMMERCIALIZED, AND
PARTNERING WITH THE FDA.
SO THESE ARE ALL TOPICS THAT WE
FEEL WE CAN DRAW ON BECAUSE OF
OUR COLLECTIVE EXPERIENCES
ACROSS THIS AMAZING GROUP OF 19
DIFFERENT INSTITUTES, CENTERS
AND OFFICES.
THANK YOU.
>> THANKS.
I THINK -- WELL, I'M THE OTHER
DISCUSSANT, SO DO YOU WANT ME TO
MENTION A FEW THINGS?
>> PERFECT, YES, THANK YOU,
LINDA.
I WAS JUST ABOUT TO CALL ON YOU.
>> OKAY.
ALL RIGHT.
WELL, THANK YOU AGAIN FOR THIS
PRESENTATION AND YOU GUYS,
DR. CHIANG AND DR. TROMBERG, YOU
GUYS AND YOUR TEAM OF 50 PEOPLE
HAVE DONE AN AMAZING JOB OF, YOU
KNOW, DELINEATING SOME OF THE
DIFFERENT POINTS AND THE THINGS
FOR THIS CONCEPT.
I THINK IT'S A GREAT CONCEPT
OVERALL, AND I AGREE WITH
EVERYTHING THAT KEVIN MENTIONED
ALREADY TOO SO I'M NOT GOING TO
REITERATE THOSE.
SO I'M JUST GOING TO MENTION A
COUPLE PROBLEMS THAT I SEE WITH
FEASIBILITY AND I'M SURE YOU'VE
THOUGHT ABOUT THEM AND YOU
STARTED TO TALK ABOUT SOME OF
THEM ALREADY.
AND ALSO I THOUGHT WHAT YOU ARE
PROPOSING IS ACTUALLY SO SIMILAR
TO WHAT THE NEW NIH DIRECTOR
JUST PRESENTED.
DID YOU SEE THIS MORNING?
HE HAS THIS REAL WORLD DATA
PLATFORM THAT HE MENTIONED.
IT'S LIKE THE SAME THING AS WHAT
YOU'RE TRYING TO DO, EXCEPT I
DON'T KNOW IF HE MEANT TO APPLY
THAT JUST TO AUTISM OR TO ANY
DISEASE.
YOU SHOULD GO BACK AND LOOK AT
THAT SLIDE.
IT LOOKS EXACTLY THE SAME AS
WHAT YOU'RE PLANNING TO DO, AND
MAYBE YOU CAN TEAM UP WITH HIM
AND GET MORE FUNDING FOR THIS.
ANYWAY, SO MY TWO AREAS THAT I
WANT TO BRING UP REGARDING
POSSIBLE FEASIBILITY ISSUE, THE
FIRST ONE HAS TO DO WITH THE
INPUT DATA.
SO YOU ALREADY SAW FROM THE
EXECUTIVE SUMMARY FROM YOUR RFI
THAT THE FIRST ITEM THEY
EMPHASIZE DATA INTEGRATION AND
ADJUSTING -- DATA HARMONIZATION
BECAUSE I CAN TELL YOU I'M
INVOLVED IN THIS BIG MULTICENTER
STUDY, 21 SITES FOR THE ABCD
STUDY AND WE HAVE LIKE THE SAME
PROTOCOL THAT'S IDENTICAL, THREE
TESLA SCAN ACROSS ALL THE SITES
AND THE SAME ALREADY OPTIMIZED
IMAGING PROTOCOL BUT WE HAVE
DIFFERENT VENDORS LIKE GE AND
PHILLIPS AND SIEMENS, AND EVEN
WITH THAT, IT'S SO HARD TO
HARMONIZE WHEN WE END UP HAVING
TO THROW OUT DATA IN ORDER TO
GET REASONABLE RESULTS TO
MINIMIZE THE VARIABILITY, SO
YOU'RE GOING TO BE -- IF YOU'RE
GOING TO BE WORKING WITH
CLINICAL DATA FROM EVERYWHERE,
YOU'RE GOING TO GET EHR,
ELECTRONIC HEALTH RECORD FROM
DIFFERENT HOSPITALS, FROM
DIFFERENT CLINICIANS,
EVERYBODY -- YOU JUST MENTIONED
THIS EARLIER, EVERYBODY CHARTS
THINGS DIFFERENTLY, ARE THEY
GOING TO ENTER UNIFORMLY KIND OF
LIKE THE WAY WE DO DATA
COLLECTION WITH THE SCIENTIFIC
PROTOCOL, THAT WOULD CERTAINLY
HELP MAYBE, I DON'T KNOW, BUT IT
JUST SEEMS LIKE IN ORDER FOR
THIS TO WORK, YOU WILL NEED
BILLIONS OF TRAINING DATASETS,
LIKE THE WAY CHATGPT WAS
DEVELOPED WITH BILLIONS OF
WEBSITES USED SO I'M JUST NOT
SURE ANY ONE OR TWO SITES, ONE
OR TWO INSTITUTIONS CAN ACTUALLY
ACHIEVE THIS GOAL, AND IN SOME
SENSE, DEVELOPING ALGORITHM TO
DEFINE THE DATASET YOU
MENTIONED, THE FUNNELING OR
WHATEVER, TO IMPROVE MEDICAL OUT
COME, IT'S A VERY -- IT'S LIKE
AN APPLIED PROJECT BECAUSE I
THINK A LOT OF ALGORITHMS ARE
ALREADY AVAILABLE.
YOU SAW EVEN WITH YOUR NIH AWARD
THAT THERE ARE MANY, MANY PEOPLE
DEVELOPING ALGORITHMS BUT THEY
JUST DON'T APPLY THEM, RIGHT?
SO YOU NEED TO BRING IT
TOGETHER.
SO IT'S JUST FINDING THE DATA
WOULD BE VERY DIFFICULT, SO
THAT'S MY FIRST POINT.
AND THEN THE SECOND POINT IS I
THINK YOU HAVE VERY LIMITED
BUDGET.
I KNOW KEVIN MENTIONED THE
BUDGET IS APPROPRIATE, BUT IF
YOU GO ONLINE AND JUST LOOK AT
HOW MUCH IT COSTS FOR OPEN AI OR
AI DEVELOPMENT IN THE PRIVATE
VENTURE FUNDS, I THINK THEY
INVEST OVER A HUNDRED BILLION
DOLLARS PER YEAR, I THINK IN
2024, THEY SAID THEY INVESTED
$110 BILLION A YEAR TO DEVELOP
AI TOOLS, AND I CAN TELL YOU
MOST OF THEM ARE ACTUALLY FOR
MEDICAL APPLICATIONS.
SO IT LOOKS LIKE THE PRIVATE
MONEY IS OUTSPENDING NIH BY
ORDERS OF MAGNITUDE, SO I THINK
YOU NEED A LOT MORE MONEY TO
MAKE THIS TO WORK.
I LOOKED UP ABOUT -- I THINK
FDA-APPROVED A LOT OF -- 900AI
MACHINE LEARNING ENABLED MEDICAL
DEVICES LAST YEAR ALONE, SO
THOSE WILL CONTINUE TO RAMP UP,
SO GLOBAL AI IN HEALTHCARE
MARKET IS PROJECTED TO REACH
$164 BILLION BY 2030.
SO I THINK YOU WOULD NEED MORE
MONEY.
THE FINAL POINT ABOUT NEEDING
MORE MONEY HAS TO DO WITH
INFRASTRUCTURE BECAUSE IN ORDER
TO MAINTAIN -- YOU NEED A LOT OF
COMPUTING POWER, LIKE FOR
INSTANCE, CHATGPT COSTS
SOMETHING LIKE OPEN AI, THEY
SPEND $700,000 A DAY TO RUN
CHATGPT AND I TALKED TO SOME OF
MY COLLEAGUES THAT ARE DOING AI
RESEARCH IN RADIOLOGY, AND THEY
SAID THAT A LOT OF PEOPLE IN
ACADEMIA HAVE A REALLY HARD
TIME, SO IF NIH CAN PROVIDE SOME
KIND OF COMPUTING INFRASTRUCTURE
TO ENABLE THE SCIENTISTS, LIKE
SOME SORT OF OPEN COMPUTING
RESOURCE THAT ALLOW RESEARCHERS
TO TRY EVEN MIDDLE SIZED
NETWORKS, SO EVEN THE SMALLEST
LLM NETWORK IS CHALLENGING FOR
MOST OF THE RESEARCHERS IN
ACADEMIA, SO THOSE ARE MY
POINTS.
I JUST THINK IT MIGHT HELP WITH
WHAT YOU WANT TO DO, BUT YOU
SHOULD ASK FOR MONONUCLEOSIS EE,
I THINK.
MON
-- FOR MORE
MONEY.
>> I'LL START HERE AND SAY THANK
YOU FOR MAKING THOSE THREE
THINGS.
TO ME, IT SEEMED LIKE YOU MADE
THREE POINTS.
TWO OF THEM, INPUT DATA, GARBAGE
IN, GARBAGE OUT, AND WE NEED TO
STANDARDIZE DATA, TOTALLY AGREE.
PERHAPS ONE OF THE APPROACHES
WE'LL TAKE IS DEVELOPING AI
METHODS TO HELP WITH TA STAN
STANDARDIZATION AND
METHODIZATION.
COMPUTING POWER, WE'VE
DEFINITELY TALKED ABOUT THIS.
THERE'S AN ADVISOR THAT THE NIH
COUNCIL, THE ACD, HAS A WORKING
GROUP ON AI.
BOTH BRUCE AND I SPOKE TO THAT,
AND THAT TOPIC CAME UP IN
DISCUSSIONS.
SO TOTALLY AGREE, TOTALLY AGREE.
YOUR THIRD COMMENT ABOUT BUDGET,
I'M NOT PERMITTED TO OPINE ON AS
A GOVERNMENT EMPLOYEE, SO I WILL
JUST THANK YOU FOR MAKING THAT
COMMENT.
>> I WAS JUST LOOKING AT HOW
MUCH INDUSTRY IS SPENDING, WHAT
YOU'RE TRYING TO DO IS LIKE A
DROP IN THE BUCKET COMPARED TO
WHAT THEY ARE DOING, SO IT LIKE,
I KNOW YOU HAVE TO START
SOMEWHERE, AND ALSO FOCUSING ON
IMAGING IS REALLY GREAT.
I DO IMAGING RESEARCH SO I
REALLY SUPPORT THAT, BUT I JUST
FEEL LIKE HOW MUCH CAN YOU DO
COMPARED TO WHAT THE REST OF THE
WORLD IS DOING.
>> IF I MAY JUST JUMP IN QUICKLY
HERE.
I JUST WANT TO HIGHLIGHT, RI LI,
ONE OF THE COMMENTS THAT YOU
MADE ACTUALLY I THINK IS REALLY
ESSENTIAL TO UNDERSTAND THAT
THIS IS -- WELL, THIS IS A
REALLY FANTASTIC CONCEPT IN AND
OF ITSELF AS A STANDALONE
PROGRAM, INHERENTLY IT'S NOT
GOING TO FUNCTION IN A VACUUM OR
IN A SILO.
SO YOU HIGHLIGHTED A
PRESENTATION THAT
DR. BHATTACHARYA MADE THIS
MORNING AND HIS REMARKS ABOUT
THIS REAL WORLD DATA PLATFORM.
SO WE FULLY EXPECT THAT PRIMED
AI WILL BE ONE OF THE DATA
SOURCES AND ONE OF THE PLATFORMS
THAT BECOME INTEGRATED THROUGH
THAT REAL WORLD DATA PLATFORM.
JUST LIKE THE NCATS N3C OR THE
NIA LINKAGE OR THE NCIC -- THERE
ARE SO MANY EXISTING EFFORTS AND
DATA INFRASTRUCTURES ACROSS THE
NIH THAT DESERVE TO COMMUNICATE
AND TALK TO ONE ANOTHER, AND BE
JOINED WITH OTHER REAL WORLD
DATASETS SUCH AS THOSE
DR. BHATTACHARYA MENTIONED THAT
WE ARE IN DISCUSSIONS WITH OUR
FEDERAL PARTNERS ACROSS THE
GOVERNMENT TO ACCESS IN A SECURE
FASHION.
AND SO I THINK THAT THAT WILL
PROBABLY PROVIDE SOME OF THE
INFRASTRUCTURE BOTH FROM THE
STORAGE AND THE COMPUTE SIDE
THAT YOU'RE A LITTLE CONCERNED
ABOUT IN YOUR COMMENTS ABOUT
THIS PARTICULAR PROGRAM.
SO IT WILL BE OPERATING AS SORT
OF A PIECE OF A LARGER VISION.
>> I THINK SO.
THAT'S A GOOD POINT.
WHEN I SAW THAT CHART THIS
MORNING, I THOUGHT THAT'S
EXACTLY WHAT THIS CONCEPT IS
ABOUT.
>> WELL, WE THINK IT'S REALLY A
GOOD FRAMEWORK FOR THIS BROADER
AMBITION THAT EVERYONE HAS,
WHICH IS TO INTEGRATE DATA
THAT'S COMMONLY ACQUIRED IN
CLINICAL INTERACTIONS AND GET
MORE OUT OF IT.
>> RIGHT.
>> AND THE IMAGING COMMUNITY HAS
BEEN DOING THAT BY COMBINING
PHYSICS MODELS WITH AI-BASED
APPROACHES SINCE I GUESS PEOPLE
STARTED DOING MACHINE LEARNING
IN THE 90s.
AND SO WE HOPE TO BUILD ON THAT
CULTURE, THE QUANTITATIVE
IMAGING BIOMARKERS PROGRAM THAT
WE STARTED AT NIBIB AND IS
CONTINUING WITH RSNA AND OTHER
EXTERNAL SUPPORT.
THE IMAGING PHANTOM TECHNOLOGY
PROGRAM THAT WE'VE STARTED WITH
NIST AND FDA SO WE CAN
DISTRIBUTE THOSE RESOURCES TO
OUR COMMUNITY TO HELP HARMONIZE
SOME ASPECTS OF DATA, AND THE
GENERAL ENGAGEMENT OF
PROFESSIONAL SOCIETIES LIKE AA
PM AND RSNA AND ACR, ESPECIALLY
THE PHYSICS AND ENGINEERING SIDE
WHERE PEOPLE ARE VERY, VERY
CONCERNED AND COGNIZANT OF THE
COMPUTATIONAL RESOURCES THAT ARE
NEEDED, AND ALWAYS WORRIED THAT
THESE KIND OF INVERSE PROBLEMS
THAT WE'RE TRYING TO SOLVE ARE
ILL POSED, AND ARE OBSESSIVE
ABOUT TRYING TO REDUCE BIAS IN
THE INPUT DATA THAT'S GOING IN.
SO WE THINK, AND WE'VE SEEN IN
THE PAST, HOW THIS COMBINATION
OF CULTURES CAN LEAD TO REALLY
BETTER OUTCOMES, AND IN
COMPARISON TO THE OPEN AI
APPROACHES AND STAR GATE AI,
THEY'RE REALLY PLOFFING QUICKLY
TOWARDS THE SUPER OBVIOUS OR
FAST COMMERCIALIZATION
OPPORTUNITIES.
THEY'VE IDENTIFIED MARKETS,
THEY'RE MOVING QUICKLY TO THAT,
AND BRINGING IN MORE BRUTE FORCE
TYPE OF LARGE LANGUAGE MODELS
AND GENERATIVE TECHNIQUES.
WE SEE A MORE REFINED APPROACH
FROM OUR COMMUNITY NOT
NECESSARILY THE BIG COMMERCIAL
MARKETS AT THE OUT IT IS SET BUT
GETTING TO TRUTHS THAT
CLINICIANS ARE SEEKING AND OUR
SCIENTISTS ARE SEEKING THAT ARE
RELATIVELY LOW HANGING BECAUSE
WE'RE JUST LEAVING SO MUCH
INFORMATION WHEN YOU GENERATE
THAT IMPRESSION FROM YOUR
RADIOLOGY REPORT, OH, MY GOSH,
THERE'S JUST SO MUCH MORE THERE.
SO THAT'S HOW WE'LL TRY TO
NAVIGATE BETWEEN THIS SORT OF
BIG, BIC MONEY REQUIREMENT AND
ENORMOUS -- AND YOU'RE
ABSOLUTELY CORRECT ON AN
ESTIMATE, BOTH THE MONEY AND THE
INFORMATION, THE DATA CONTENT,
THAT HAS TO GO FORWARD.
BUT I THINK WE'RE IN A UNIQUE
POSITION WITH OUR COMMUNITIES
WHERE WE CAN MAKE A LOT OF
PROGRESS RIGHT NOW IN THESE
AREAS THAT ARE NOT NECESSARILY
FOCUSED ON BY THE BIG CAPITAL
INTERESTS.
>> YEAH.
IN MARYLAND ACTUALLY, WE JUST --
MONTGOMERY COUNTY AND ALSO THE
UNIVERSITY OF MARYLAND MEDICAL
SYSTEM, THEY JUST CREATED A NEW
INSTITUTE WITH THE MEDICAL
SCHOOL CALLED THE INSTITUTE OF
HEALTH COMPUTING, AND THEY
STARTED WITH $70 MILLION TO
START AND THEN THEY GOT THE
STATE TO AGREEL TO GIVE THEM --
THIS IS OUR TAX DOLLARS -- TO
CONTINUE TO FUND THEM AT THE
TUNE OF ABOUT $6 MILLION A YEAR
JUST TO MAINTAIN IT, AND THEY'RE
DOING SOMETHING VERY SIMILAR TO
WHAT YOU ARE TALKING ABOUT.
THEY'RE STARTING WITH THE EHR
RECORD AND INPUTTING ALL THE
DATA.
IT'S NOT IMAGING-FOCUSED BUT
STILL THE CONCEPT IS THE SAME,
INTEGRATING CLINICAL WITH ALL
THE LABS AND EVERYTHING ELSE
THEY CAN GET TOGETHER TO IMPROVE
PREDICTION AND DIAGNOSIS FOR
PATIENTS.
SO ANYWAY, YOU MIGHT WANT TO
TALK TO THEM TOO.
THEY SEEM TO BE SPENDING A LOT
MORE MONEY ON WHAT THEY'RE
DOING, SO --
>> YEAH, THANK YOU.
>> IT'S CALLED THE IHC,
INSTITUTE OF HEALTH COMPUTING.
THEY'RE ACTUALLY LOCATED ACROSS
THE STREET FROM YOU AT THE --
AREA.
>> GREAT.
THANK YOU FOR THE SUGGESTIONS.
OKAY.
WE HAVE SEVERAL OTHER
COUNCILMEMBERS WHOSE HANDS ARE
RAISED TO CONTRIBUTE TO THE
DISCUSSION, SO I'M GOING TO TURN
TO RHONDA FIRST.
>> THANK YOU.
YOU TALK ABOUT REALLY INNOVATIVE
IDEA, THIS IS DEFINITELY ONE OF
THOSE BIG IDEAS BUT IT'S ALSO A
HUGE PROJECT.
THE THING THAT I FEAR THE MOST
BECAUSE THIS IS A DIRECTION THAT
MANY STAKEHOLDERS ARE GOING INTO
ALREADY, THAT IF IT'S NOT
MANAGED WELL WILL HAVE A MASSIVE
FRAGMENTATION OF ALL DIFFERENT
TYPES OF APPROACHS THAT WON'T
HAVE ANY INTEROPERABILITY AT ALL
AND JUST PROVIDE MORE CONFUSION.
SO I DO THINK -- ONE OF MY
QUESTIONS IS, WHAT IS THE MOST
UNIQUE AND VALUABLE ROLE THAT
NIH WOULD PLAY IN THIS?
AND THERE ARE SOME UNIQUE
CAPABILITIES THAT YOU HAVE THAT
I THINK WOULD BE VERY, VERY
IMPORTANT IN MOVING THIS FORWARD
AS A NATIONAL PROCESS.
I DO THINK THAT ONE OF THE
THINGS THAT YOU DO HAVE IN YOUR
BACK POCKET IS THAT YOU CAN,
BECAUSE OF YOUR POSITION,
BECAUSE OF HOW YOU'RE FUNDED,
THAT YOU WOULD HAVE SOME
REGULATORY NAVIGATION SKILLS AND
CREDIBILITY, SO THAT THAT'S
GOING TO BE IMPORTANT TO BEGIN
TO BRING IN OR HONE IN WHAT
NEEDS TO BE STANDARD AND WHAT
ISN'T, AND YOU ALSO HAVE THE
ABILITY TO TEST OUT THROUGH YOUR
FUNDING, THROUGH OTHERS DOING
IT, BUT HAVING THE GUIDELINES OR
THE WAY OF TESTING SOMETHING TO
BE ABLE TO DECLARE IT AS A
STANDARD IN SOME WAY.
I THINK THAT'S VERY, VERY MUCH
SO IN YOUR AREA.
I AGREE WITH THE LAST PERSON WHO
COMMENTED, THE AMOUNT OF MONEY
IN THIS IS JUST TREMENDOUS, I
DON'T SEE THIS BEING NIH-FUNDED,
BUT I DO SEE THERE ARE MULTIPLE
INVESTORS OUT THERE THAT ARE IN
THIS.
BUT I THINK WITH A STRONG SENSE
OF A REGULATORY PIECE THAT IS
GOING TO BE APPLIED TO THIS WILL
HELP BRING SOME OF THOSE
INVESTORS WHO WANT TO BE IN THIS
SPACE TO START WORKING WITH YOU,
BECAUSE I THINK THAT'S GOING TO
BE EXCEPTIONALLY IMPORTANT IN
TERMS OF BRINGING THE
CONTINUITY, THE STANDARDIZATION
AND ALL OF THAT THAT WILL ALLOW
THIS TO WORK.
OTHER THAN THAT, I TAKE MY HAT
OFF TO YOU TO SAY THIS IS A HUGE
PROJECT, EXCEPTIONALLY
IMPORTANT, THERE ARE A LOT OF
ORGANIZATIONS THAT ARE DOING
THIS THAT HAVE LOTS OF KIND OF
DATA AND I THINK THERE'S A WAY
OF CAPITALIZING OFF WHAT'S BEEN
STARTED, FIGURING OUT WHAT YOUR
UNIQUE ROLE, WHAT YOU'RE
UNIQUELY CAPABLE OF DOING THAT
THEY CANNOT, AND ALSO
RECOGNIZING THAT THE
STANDARDIZATION OF DATA BUT ALSO
THE ALGORITHMS AND ALL OF THAT
NEEDS TO BE HELD BY SOMETHING
THAT HAS TESTED IT OUT AND CAN
DEMONSTRATE TO THOSE WHO ARE
PARTICIPATING WHAT IS MORE
VALUABLE, WHAT'S MORE VALID IN
THE LONG RUN.
SO THANK YOU FOR THE OPPORTUNITY
TO COMMENT.
>> THANK YOU.
MIKE, DO YOU WANT TO START?
>> RHONDA, I WOULD JUST SAY
THANK YOU.
I SEE A LOT OF HANDS RAISED SO I
DON'T WANT TO TALK TOO LONG
EXCEPT TO SAY THANK YOU VERY
MUCH.
WE HAVEN'T MET BUT I SEE WHERE
YOU'RE FROM AND I WOULD LOVE TO
SORT OF HAVE FUTURE
CONVERSATIONS ABOUT THIS.
YOU MENTIONED A LOT OF -- I FEEL
LIKE YOU ANSWERED THE QUESTION
THAT YOU ASKED IN SOME WAYS,
VALIDATION STANDARDS, WORKING
ACROSS FEDERAL AGENCIES LIKE
FDA, CMS AND OTHER PAYOR,
PUBLIC-PRIVATE PARTNERSHIPS AND
ULTIMATELY WE WANT TO TRY TO
ADVANCE A WHOLE THAT'S GREATER
THAN THE SUM OF THE PARTS, NOT
ONE THAT'S AS YOU SAID
FRAGMENTED AND LESS THAN THE SUM
OF THE PARTS BECAUSE IT'S ALL
CONFUSING AND I DO THINK WE CAN
PLAY A BIG ROLE IN THAT AT NIH.
BUT THANK YOU.
>> AND SO JUST ADDING ON TO
MIKE'S COMMENT, WE'RE GOING TO
BRING TO BEAR ALL OF THE
EXPERIENCES AND RESOURCES THAT
WE'VE HAD COLLECTIVELY AS OUR
NIH COMMUNITY, AND THOSE
INVOLVED BUILDING NEW
CAPABILITIES IN EXACTLY THOSE
AREAS THAT YOU MENTIONED.
SO WE HAVE VERY STRONG
RELATIONSHIPS WITH CDRH, DIGITAL
HEALTH, THE OHTs WITHIN THE
FDA, AND IN THE
COMMERCIALIZATION COMMUNITY,
WHERE WE CAN BRING EXPERTS IN TO
SHARPEN AND REFINE IDEAS AND
THEN TO VALIDATE AND TEST THE
ALGORITHMS THAT ARE UNDER
DEVELOPMENT AND GET TO A DEEPER
UNDERSTANDING OF EXACTLY HOW
THEY WORK AND POTENTIAL MARKETS
FOR THIS.
SO WE ARE -- WE HAVE SOME UNIQUE
SKILLSETS AND CAPABILITIES AT
THE NIH EXACTLY IN THE AREAS
THAT YOU BROUGHT UP, AND WE ARE
ABSOLUTELY GOING TO HAVE TO
BRING THEM TO BEAR IN THIS
PROGRAM.
>> AND I THINK ABOUT IT FROM THE
STANDPOINT OF VIEW OF
INVESTMENTS THAT ARE BEING MADE
AND THAT WILL BE MADE, AND WHAT
WOULD DRAW INDIVIDUALS TO INVEST
IN A UNIFORM APPROACH.
WHAT WOULD BRING THE VALUE TO
THEM?
AND I THINK THAT'S EXCEPTIONALLY
IMPORTANT BECAUSE I'M SORRY, NIH
CANNOT PAY FOR ALL OF THIS.
THIS IS JUST TOO LARGE, TOO
COSTLY.
SO YOU'RE GOING TO NEED TO HAVE
THOSE WHO ARE CONTRIBUTING IN A
WAY THAT WOULD MAKE THIS PROJECT
KEEP GOING AND KEEP GOING ON THE
LARGE SCALE THAT YOU ARE
ANTICIPATING.
THANK YOU.
>> THANK YOU, RHONDA.
RAFAEL?
>> HI, THANK YOU.
SO I WANT TO SHARE MY MAIN
CONCERN ABOUT THIS PROPOSAL AND
IT'S THE -- IT RELATES TO WHY
IT'S FAILED SO MANY TIMES AND SO
MANY INSTITUTIONS.
AND IT HAS TO DO WITH THE
DIFFICULTY IN SHARING DATA,
CLINICAL DATA.
THERE'S SO MANY REGULATIONS AND
CONCERNS ABOUT PRIVACY AND
HOLDING FROM INVESTIGATORS THAT
GET TO WRITE MORE PAPERS, I'VE
YET TO SEE ANY INSTITUTION
SUCCEED AND IT'S NOT BECAUSE OF
LACK OF MACHINE LEARNING METHOD,
IT'S NOT BECAUSE OF LACK OF DATA
FOR SURE.
IT'S JUST -- IT'S LACK OF THE
ABILITY TO SHARE DATA AND I
DON'T KNOW IF IT'S THE CASE, BUT
IT DOES SEEM LIKE THE ONE BIG
DRIVER OF THAT ARE NIH
REGULATIONS THAT HAVE THIS
INDIRECT EFFECT OF MAKING IT
HARD TO SHARE, EVEN WITHIN
INSTITUTIONS.
THERE'S ALSO PLENTY OF EXAMPLES
WHERE MACHINE LEARNING EXPERT
CLAIMS VICTORY, PA THOL JITSES,
RADIOLOGISTS ARE NO LONGER
NEEDED MY METHOD IS BETTER THAN
THEM, THEY GET A SCIENCE PAPER,
BUT THEN WHEN THEY TRY IT AT ANY
OTHER HOSPITAL, IT FAILS
COMPLETELY.
SO YOU NEED TO TEST ACROSS
HOSPITALS, AND ACROSS
MEASUREMENT, WHEREVER
MEASUREMENTS ARE BEING TAKEN,
AND JUST TO DEVELOP METHODS THAT
ARE ROBUST TO THAT, WHICH I
DON'T THINK ARE AROUND YET, YOU
HAVE TO SHARE DATA ACROSS SITES.
WE CAN'T EVEN SHARE DATA WITHIN
SITES, HOW ARE WE GOING TO SHARE
DATA ACROSS SITES?
THAT DOES SEEM TO BE NOT A
TECHNICAL OR SCIENTIFIC PROBLEM,
IT SEEMS TO BE COMPLETELY A
POLITICAL PROBLEM.
AND A LOT OF IT HAVING TO DO
WITH PRIVACY REGULATIONS, WHICH
MAYBE THEY'RE NECESSARY, BUT I
DON'T THINK WE CAN HAVE BOTH THE
PRIVACY REGULATIONS AND THE
ABILITY TO SHARE DATA AS WE NEED
TO TO MAKE THIS SUCCEED.
SO I'M WONDERING IF THERE WILL
BE SOME KIND OF INCENTIVE OR
SOME KIND OF PROCEDURE TO
FACILITATE THIS HURDLE THAT'S
BEEN AROUND FOR 20 YEARS NOW.
AND HAS KEPT PEOPLE FROM
SUCCEEDING AT PROJECTS LIKE
THIS.
THANK YOU.
>> RAFAEL, THANK YOU FOR RAISING
THAT.
AS I SEE IT, YOU'VE MENTIONED
TWO CONCEPTS.
ONE IS TESTING ACROSS HOSPITALS.
VALIDATION.
AND I THINK THAT'S EXTREMELY
IMPORTANT.
THAT'S EXACTLY THE PREMISE OF
WHAT WE'RE TRYING TO ADDRESS
WITH THIS VALIDATION CENTER, TO
PROVE THAT WE HAVE
GENERALIZABILITY.
YOUR BIGGER COMMENT WAS ABOUT
DATA SHARING AND CULTURE AND
REGULATIONS.
TOTALLY, TOTALLY, TOTALLY,
TOTALLY AGREE WITH THAT.
WE PUBLISHED AN NIH DATA SHARING
REQUIREMENT TWO YEARS AGO AND
THE COMMUNITY HATES IT.
FOR EXACTLY THE REASON THAT YOU
MENTIONED.
WE'VE HEARD EVERY SINGLE
COMPLAINT.
AND I JUST WANTED TO HIGHLIGHT
ONE THING THAT I BELIEVE YOU
HEARD IN THE SCIENCE OF SCIENCE
THING, IT'S OUR FIRM BELIEF THAT
THESE ARE THE SMARTEST PEOPLE IN
THE WORLD THAT WE'RE DEALING
WITH AND IF WE INCENTIVIZE
PEOPLE TO WANT TO DO SOMETHING,
THEY WILL WANT TO DO T WE'VE
REALLY BEEN TRYING TO PUSH THIS
NIH DATA SHARING SO CALLED S
INDEX CHALLENGE.
CAN WE DEVELOP A METRIC THAT
WILL GO UP IF YOU SHARE MORE
DATA AND IT'S GOOD AND CAN WE
GET -- CAN WE WORK WITH GOOGLE
SCHOLAR, PICK YOUR DIFFERENT --
PEOPLE REALLY PUBLICIZE THIS AND
GET INTO PROMOTION AND TENURES,
I THINK THAT'S ONE OF THE WAYS
THAT WE CAN HELP DRIVE CULTURE
CHANGE TO REALLY PUSH THIS
FORWARD AND ADDRESS THE THINGS
THAT YOU'RE TALKING ABOUT.
SO RAFAEL, THANK YOU.
>> THAT'S ALL RIGHT.
I HAVE A COULD A CONCRETE SUGGEN
WHICH IS TO MAKE PEOPLE PUT
THEIR MONEY WHERE THEIR MOUTH
IS.
YOU COULD HAVE A REQUIREMENT FOR
THE FUNDING OPPORTUNITY, THAT IF
YOU CAN'T DEMONSTRATE THAT IN
YOUR INSTITUTION, YOU'RE NOT
SHARING DATA, EHR DATA IS STUCK
IN ONE PLACE, JUST ONE
INVESTIGATOR THAT SOMEHOW
HAPPENED TO GET THEIR HANDS ON
IT, THEN THEY DON'T GET TO
PARTICIPATE.
I DON'T KNOW IF THERE'S A WAY TO
DO THAT, BUT I THINK UNDER THE
INSTITUTIONAL METRIC THAT WE
HAVE IN GRANTS, WE MIGHT REQUIRE
THAT THEY DEMONSTRATE VERY
CLEARLY THAT THEY ARE, IN FACT,
CAPABLE OF SHARING DATA.
OTHERWISE YOU'RE GOING TO GIVE
FUNDING TO AN INSTITUTION AND
THEY'RE JUST -- IT'S IMPOSSIBLE
FOR THEM OR THEY DON'T WANT TO
DO IT AND YOU WANT TO GET STUCK
WITH -- MAYBE THEY'LL HAVE
PAPERS BUT THEY WON'T ACTUALLY
HELP YOU SUCCEED.
>> MAYBE I COULD JUST JUMP IN,
WE'LL BUILD -- WE HAVE SOME
SUCCESSES IN THE IMAGING
COMMUNITY, SOME PRECEDENCE, SO I
MENTIONED THE MIDRC CONSORTIUM,
WHICH IS 24 DIFFERENT
INSTITUTIONS AND THREE MAJOR --
>> ABSOLUTELY.
I'M MORE CONCERNED ABOUT EHR.
>> WELL, THAT GROUP ACTUALLY --
IT TOOK A COUPLE OF YEARS, FIRST
TO SHARE THE IMAGING DATA, AND
NOW THE OTHER -- THE EHR AND
CLINICAL DATA IS BEGINNING TO
FLOW.
SO IT'S BEEN A STRUGGLE, BUT I
THINK THAT AS PEOPLE SEE THE
OPPORTUNITIES AND ADVANTAGES AND
SYSTEMS THAT ARE STRUCTURED IN A
WAY THAT CAN HELP FACILITATE IT,
THEY'LL EMULATE THOSE HOPEFULLY
AS WE PROGRESS.
IT ALSO BRINGS UP THE FEDERATED
LEARNING APPROACH AND SOMETIMES
THAT'S THE OPTION TO MOVE
TOWARDS AS ONCE YOU'VE EXHAUSTED
YOUR DATA REPOSITORIES FROM A
FEW DIFFERENT SITES AND THEN YOU
WANT TO ENGAGE OTHER PARTNERS
AND OTHER SITES.
BUT DEFINITELY BIG PROBLEM.
>> THANK YOU.
>> MOVING TO RUSSELL.
>> GREAT.
THANK YOU BOTH FOR A PHENOMENAL
PRESENTATION.
THIS IS OBVIOUSLY SO IMPORTANT
TO THE FUTURE OF ALL OF MEDICINE
ANDLY APPRECIATE YOU BRINGING
THIS FORWARD AS AN INITIATIVE.
I WANT TO ADDRESS A LITTLE BIT
OF RAFAEL'S COMMENTS AND KEVIN'S
COMMENTS AND THEN I HAVE A
QUESTION.
KEVIN'S COMMENTS WITH RESPECT TO
AI READY AND THE LESSONS
LEARNED, COULD NOT AGREE MORE.
I'VE HAD A RINGSIDE SEAT FROM
THE CONCEPT CLEARANCE FOUR YEARS
AGO AND ONE OF THE MAJOR
PROGRAMS IS BASED AT MY
UNIVERSITY, SO I'VE GOTTEN TO
SEE HOW THAT HAS PROGRESSED AND
IT HAS BEEN REMARKABLE.
FIRST OF ALL, THE OVERCOMING
CHALLENGES TO CREATING THESE
DATASETS WAS SIGNIFICANTLY
GREATER THAN ONE WOULD HAVE
ANTICIPATED, AND THAT DID GET
INTO INTEROPERABILITY ISSUES,
DATA SHARING ISSUES.
THE TRIVIAL THINGS OF, YOU KNOW,
MEMORANDA OF UNDERSTANDING
BETWEEN ORGANIZATIONS TO SHARE
THE DATA IN THE FIRST PLACE AND
THE LACK OF STANDARDIZATION
AROUND THOSE CREATED VERY LARGE
BUREAUCRATIC BARRIERS TO RAPIDLY
DEPLOYING, ALL OF WHICH, THOUGH,
WERE EVENTUALLY OVERCOME, AND AT
THIS POINT, AT LEAST THE AI
READY PROJECT, WHICH I'M MOST
FAMILIAR WITH, IS ON TRACK TO
COMPLETE ITS 4,000 SUBJECT
MULTIMODAL DENSE DATASET
ENROLLMENT ON TIME BY THE END OF
THE FOURTH YEAR.
IN FACT, TO YOUR POINT, RAFAEL,
THE DATA SHARING IS A
REQUIREMENT OF THAT GRANT, AND
IF YOU GO TO AIREADY.ORG, I
THINK IT IS, YOU WILL SEE THE
CURRENT DATASET.
IT'S UP, YOU CAN DOWNLOAD IT,
AND IT'S WELL OVER A THOUSAND
SUBJECTS WITH COMPLETE DATASET
THAT ARE AVAILABLE FOR ANYONE
JUST LIKE ALL OF US OR ANY OF
THE OTHER LARGE DATASETS.
I THINK THIS IS SOMETHING NIH
UNIQUELY BRINGS TO THE FIELD, IS
THE ABILITY TO REQUIRE OPEN
SHARING OF DATA AS A REQUIREMENT
FOR FUNDING AND I THINK THAT'S
VERY, VERY POWERFUL HERE.
I ALSO WANT TO ADDRESS A LITTLE
BIT OF THE COMMENTS ABOUT DATA
INTEROPERABILITY.
I KNOW MIKE HAS THOUGHT ABOUT
THIS EXTENSIVELY AND ACTUALLY
PUBLISHED A VERY NICE EDITORIAL
IN OUR LITERATURE WHICH HE WROTE
IN COLLABORATION WITH A LEAD AT
THE FDA, AS WELL AS AT THE
NATIONAL -- OFFICE OF THE
NATIONAL COORDINATOR FOR HEALTH
INFORMATION TECHNOLOGY.
AND THAT LATTER GROUP ACTUALLY
EXISTS TO DRIVE DATA
HARMONIZATION IN THE CLINICAL
SPHERE, AND I WOULD STRONGLY
RECOMMEND THAT THEY HAVE A SEAT
AT THE TABLE AS YOU'RE DESIGNING
THESE PROGRAMS.
YOU KNOW, DICOM IS A STANDARD,
IT'S OUT THERE, IT IS VOLUNTARY,
AND AS WE ALL KNOW, THERE ARE
VENDORS WHO SUBSCRIBE AND THERE
ARE VENDORS THAT SAY THEY
SUBSCRIBE TO DICOM.
WERE IF IT'S GOING TO BE USEFUL
FOR PREDICTION, YOU WILL NEED TO
BE IN THE DICOM SPACE TO
PARTICIPATE AND I REALLY
ENCOURAGE YOU TO LEVERAGE THAT
OPPORTUNITY TO TRY TO BRING
VENDORS TO FINALLY COMPLYING SO
THAT THEIR DATA IS INTEROPERABLE
BETWEEN SITES.
FINALLY THE QUESTION IS, IT IS
UNCLEAR FROM THE PRESENTATION
WHAT THE POLICY IS GOING TO BE
ON THE IP THAT ARISES FROM THIS.
SO YOU HAVE A VERY LARGE DATASET
OR DATASETS THAT COME OUT OF
THIS, EXTREMELY RICH, PRESUMABLY
THE COMMUNITY WILL BE ABLE TO
MINE THIS FOR IDEAS.
WHAT WILL BE THE POLICY IN TERMS
OF PROTECTION OF THAT IP,
BAUER'S AS OTHERS HAVE
MENTIONED, THERE IS A HUGE
INTEREST IN THIS IN THE
COMMERCIAL SPACE, AND TO WOULD
BE HIGHLY DESIRABLE FOR THE WORK
THAT COMES OUT OF THIS PROJECT
TO BE ABLE TO MAKE TO THE
PUBLIC.
>> MIKE, MAYBE I CAN JUST JUMP
IN ON THE IP ISSUES.
WE DON'T SEE ANY SPECIFIC AT THE
BEGINNING KIND OF AT THE OUTSET
IN THE ABSENCE OF HAVING SEEN
ANY PROPOSALS COME.
DEVIATIONS FROM OUR NORMAL IP
POLICIES.
IN FACT, WE WANT TO -- WE NEED
TO ENCOURAGE IP AND
COMMERCIALIZATION IS PROBABLY
OUR BIGGEST MECHANISM OF
DISSEMINATION, BUT THERE'S ALSO
A KIND OF CONCURRENT MOVEMENT
TOWARDS OPEN SCIENCE AND
ALGORITHMS THAT ARE WIDELY
DISTRIBUTED AND VALIDATED IN A
COMMUNITY SENSE, SO WE'LL JUST
HAVE TO SEE HOW OUR COMMUNITY IS
RESPONDING TO THIS.
YOU KNOW, MUCH OF WHAT I DO IN
TERMS OF DEVICE DEVELOPMENT, AND
I STILL HAVE A LAB AND WE DO
DEVICES AND WE MAKE THE RAW DATA
FROM THE DEVICE AVAILABLE TO OUR
ENTIRE COMMUNITY.
WE PUBLISH THE ALGORITHMS ON
GITHUB.
THIS IS A VERY STRONG MOVEMENT
WITHIN THE DEVICE AND TECHNOLOGY
DEVELOPMENT COMMUNITY.
WE PUBLISH ENTIRELY BILLS OF
MATERIALS SO PEOPLE CAN BUILD
THE SAME DEVICE OR DEVIATIONS OF
IT.
SO THIS IS QUITE A POWERFUL
MOVEMENT.
WE DON'T KNOW EXACTLY WHERE ALL
OF THIS IS GOING TO GO.
WE'RE GOING TO SEE PROBABLY A
LITTLE BIT OF ALL OF THE ABOVE,
BUT OUR MAIN PASSION IS TO BE
ABLE TO GET THIS TO PATIENTS,
AND TO BE ABLE TO MOVE AND
ACCELERATE WHAT WE KNOW ARE
FABULOUS DISCOVERIES AND NEW
INSIGHTS THAT ARE HAPPENING ALL
ACROSS THE COUNTRY, BUT PATIENTS
ARE STILL GETTING THE TWO-LINE
IMPRESSION FROM THE RADIOLOGY
REPORT.
SO I WISH I HAD AN UP FRONT
ANSWER TO ALL THIS, BUT IT'S
GOING TO BE AN EVOLVING STORY.
MIKE?
>> YOU KNOW, THANK YOU FOR YOUR
COMMENTS, RUSS.
WHEN THE HANDS STARTED GOING UP,
I DIDN'T SEE YOURS RIGHT AWAY, I
WONDERED IF SOMETHING'S WRONG,
SO GLAD TO HEAR FROM YOU NOW.
I AGREE WITH EVERY SINGLE THING
IE. JUST GOING TO HIGHLIGHT ONE
THING THAT BRUCE DID NOT TALK
ABOUT, WORKING ACROSS AGENCIES
AND THIS PROJECT THAT WE WORKED
ON WITH THE FDA AND WITH THE
OMC/ASTP, THE ASSISTANT
SECRETARY FOR TECHNOLOGY POLICY.
I WOULD JUST UNDERSCORE, RUSS,
WHAT YOU SAID, THAT IN A WORLD
WHERE THERE ARE STICKS AND
CARROTS, I THINK THERE'S A ROLE
FOR EACH OF THEM AND WE VIEW
THIS AS A CARROT.
WE TRIED TO COME UP WITH RULES
WHEN THE FIELD WASN'T MOVING IN
A CERTAIN DIRECTION AFTER ABOUT
THE 15 TO 20 YEARS THAT I'VE
BEEN INVOLVED WITH IT, WHAT CAN
WE DO IN TERMS OF STICKS TO MOVE
THAT.
THOSE WERE THE ONES THAT WE
CREATED, SO TOTALLY AGREE WE
COULD DO SOME STUFF WITH THEM
INVOLVING INTRAOPERABILITY, AND
REALLY APPRECIATE YOUR RAISING
THAT.
>> GREAT.
OKAY, THANK YOU.
OUR LAST COUNCILMEMBER WITH HER
HAND RAISED IS JEAN.
PLEASE GO AHEAD.
>> THIS IS GOING TO BE QUICK, I
HOPE.
I AM REALLY EXCITED ABOUT THIS
PROJECT.
OBVIOUSLY I DO IMAGING AND I DO
AI, THE COMBINATION IS AMAZING,
AND I'M SO EXCITED ABOUT THE
POSSIBILITIES.
YOU HAVE FUNDED --MAN BY DAVID
KENNEDY WHO ACTUALLY DID A LOT
OF THIS WORK IN TERMS OF
BUILDING TOOLS FOR THE
INTEROPERABILITY AND I THINK
OBVIOUSLY IS NIH FUNDED BY YOU.
I'M THINKING A LOT OF THOSE
TOOLS CAN BE USED HERE.
I WANTED TO GO BACK TO WHAT
LINDA SAID.
IT'S SOMETIMES REALLY DIFFICULT
IN IMAGING.
IT DEPENDS ON WHAT MACHINE, THE
STRENGTH OF THE MACHINE, WHETHER
OR NOT IT'S A PARTICULAR KIND OF
SCAN OR WHAT KIND OF SCANNING
YOU DID.
THERE'S A LOT OF WORK THERE TO
BRING THOSE PIECES TOGETHER.
I TOTALLY BELIEVE THAT THE
INTEGRATION WOULD LEAD TO
INNOVATION AND HUGE IMPACTS.
SO I'M IN, I JUST THINK A LOT OF
WHAT WE'RE SAYING IS THERE'S A
LOT OF WORK HERE PROBABLY MORE
THAN WE THINK ABOUT RIGHT NOW,
THAT CANNOT STOP US, BUT I THINK
WHEN I SAW YOU HAD MOSTLY MONEY
TOWARDS GOING FROM THE DATA TO
THE CLINIC, I THINK THAT MAY
TAKE MORAL WORK THAN WE THINK,
AND I WOULD REALLY WANT TO PUT A
LOT OF IT INTO THE INTEGRATION
PART.
ONCE WE'RE DOING GOOD
INTEGRATION AND WE HAVE THE
ALGORITHMS TO REALLY HELP US,
ESPECIALLY WITH PREDICTION, I'M
REALLY EXCITED ABOUT PREDICTION.
IT'S LOWIT'S HOW WE COULD PREDIO
WILL AND WHO WILL NOT GET A
PARTICULAR DISEASE.
I THINK THERE'S A LOT THERE.
I THINK IT CAN BLOW UP SCIENCE
AND WHAT WE THINK ABOUT IT, I
THINK IT'S GOING TO CHANGE AND
TRANSFORM THIS WHOLE ECOSYSTEM,
BUT THE INTEGRATION PART, I FEEL
THERE'S PROBABLY GOING TO NEED
TO BE MORE -- HAVING A
COORDINATED SITE WHICH I'M NOT
SURE I SAW YOU HAD IN THERE, BUT
HOW WE'LL BRING ALL THAT DATA
TOGETHER SO EVERYONE WILL BE
LEARNING AT THE SAME TIME FROM
EACH OARL AS OPPOSED TO
REBUILDING THE WHEEL OVER AN
OVER.
>> THANK YOU VERY MUCH, JEAN.
>> I THINK WE'RE BOTH IN -- IS
GE WHAT WOULD YOU SAY, VIOLENT
AGREEMENT ABOUT THAT.
AND YOU KNOW, THAT'S PART OF, I
THINK, THE BRILLIANCE OF OUR
COLLEAGUES WHO SORT OF
STRUCTURED ALL OF THESE ELEMENTS
TO FUND AND THE OVERALL PLAN,
WHICH SPENDS AN ENORMOUS AMOUNT
OF TIME AND RESOURCES MAKING
SURE THAT THE ALGORITHMS ARE
THOUGHTFULLY DEVELOPED AND
VALIDATED AND THEN CAN
POTENTIALLY PIGGY BACK ON TO
ONGOING STUDIES, THESE ANCILLARY
STUDIES THAT ARE HAPPENING
EVERYWHERE.
YOU KNOW, FROM ECOG AKRON WHICH
IS SORT OF THE BIG BEAST AT THE
NIH TO INDUSTRY SPONSORED DRUG
TRIALS WHERE THEY HAVE
LONGITUDINAL IMAGING FOR
PATIENTS BUT AGAIN, NO ONE
REALLY LOOKS AT THE IMAGES, THEY
JUST SAY A VERY BRIEF IMPRESSION
OF A FEW KILOBYTES, AND -- OR
KILOBITS, AND SO WE'RE HOPING
THE COMMUNITY REALLY JUST TAKES
ADVANTAGE OF THOSE THINGS, THE
ENORMOUS ONGOING EFFORT AND THE
ENORMOUS RESOURCES THAT WE'RE
GOING TO PUT IN, IN ADDITION TO
THE FUNDING, BUT THE EXPERTISE
THAT ALL OF US HAVE DEVELOPED
OVER THE LAST SEVERAL YEARS.
TO REALLY BRING PEOPLE TOGETHER,
AND TO ACCELERATE THE
COMMERCIALIZATION AND THE
TRANSLATION OF THESE APPROACHES.
>> THANK YOU.
I'D ALSO JUST LIKE TO HIGHLIGHT
THAT CAROLYN HAS PUT SEVERAL
COMMENTS IN THE CHAT ABOUT
HAVING EXISTING MOUs WITH FDA
TO SPECIFICALLY GET EARLY
FEEDBACK FROM THE AGENCY, SO I
THINK THAT'S AN EXAMPLE WITH
RESPECT TO SORT OF THE
REGULATORY PIECE WHERE WE ARE
ABLE TO LEARN FROM EXISTING
PROGRAMS BUT ALSO WITH THE DATA
SHARING REQUIREMENTS HAVING
THOSE CONSIDERATIONS BE BUILT
INTO THE NOFO AND HAVE THOSE
BE -- THE AWARD SELECTION AND
FUNDING BE SPECIFICALLY TIED TO
THOSE REQUIREMENTS AS WELL.
SO DEFINITELY REALLY, REALLY
APPRECIATE ALL OF THE FEEDBACK
THAT'S BEING PROVIDED HERE, AND
THAT WILL BE -- IF THIS CONCEPT
IS APPROVED, THAT WILL
ABSOLUTELY BE INTEGRATED INTO
HOW THE NOFOs ARE WRITTEN AND
HOW THE PROGRAM IS STRUCTURED.
OKAY.
I THINK THAT CLOSES THE
DISCUSSION HERE.
FRANZISKA, I'LL TURN IT OVER TO
YOU.
>> OKAY.
SO THEN THAT BRINGS US TO THE
LAST VOTE FOR TODAY.
I'M GOING TO CALL FOR A VOTE
ON --
>> BEFORE WE VOTE, SORRY, I WAS
TRYING TO UNMUTE.
CAN YOU CLARIFY A LITTLE BIT
MORE ABOUT THAT LAST COMMENT?
WE'RE VOTING FOR THE CONCEPT TO
BE APPROVED AND THEN IS THE
FUNDING THEN GUARANTEED OR IS
THERE A NEXT DISCUSSION ABOUT
IT?
>> LET ME TRY TO EXPLAIN HOW
THAT NORMALLY WORKS.
IF A CONCEPT IS APPROVED, THAT
GIVES US THE GO-AHEAD TO MOVE
FORWARD IF FUNDING IS AVAILABLE,
IF THE CIRCUMSTANCES ARE CORRECT
AND IF IF EVERYBODY'S READY TOO
IT, THAT DOES NOT GUARANTEE IT
GOES FORWARD.
OF COURSE AN IMPORTANT PART IS
THE ENTIRE DISCUSSION THAT WE
HEARD TODAY, PROGRAM STAFF WILL
TAKE ALL THOSE COMMENTS INTO
CONSIDERATION AND BUILD THOSE IN
WHICH THEN HAS AN INFLUENCE ON
WHAT YOUR QUESTION WAS.
WHAT WILL THE BUDGET BE?
WELL, IF WE BUILD MUCH -- A
BIGGER CASSELL, THEN OF COURSE
CASTLE, THE COSTS WILL BEMUCH HE
MONEY.
YOU UNDERSTAND WHAT I'M TRYING
TO SAY.
DID THAT ANSWER YOUR QUESTION,
RAFAEL?
>> ABSOLUTELY.
YEP.
>> EXCELLENT.
OKAY.
SO WE STOP THEN.
I'M GOING TO CALL FOR A MOTION.
A MOTION FOR APPROVAL OF THE
COMMON FUND CONCEPT CLEARANCE
ENTITLED PRECISION MEDICINE WITH
AI, INTEGRATING IMAGING WITH
MULTIMODAL DATA, PRIME AI
PROGRAM.
IS THERE SUCH A MOTION?
I SEE SO MOVED.
I SEE SECOND.
ANY ADDITIONAL DISCUSSION AT
THIS POINT?
I SEE NO HANDS.
I SEE NO CHAT INFO.
WE ARE DOING HOPEFULLY THE LAST
TIME OUR HAND RAISING VOTES.
CHRISTINA, PLEASE GO AHEAD.
>> THANK YOU, DR. GRIEDER.
AS A REMINDER, ONLY
COUNCILMEMBERS SHOULD
PARTICIPATE.
THIS IS A VOTE ON THE MOTION FOR
APPROVAL OF THE PROPOSED OSC
CONCEPT CLEARANCE.
PLEASE RAISE YOUR HAND NOW TO
VOTE AYE.
THANK YOU.
I SEE 12 HAN 12 HANDS VOATING A.
VOTING AYE.
PLEASE LOWER YOUR HANDS.
PLEASE LOWER YOUR HANDS, ONE
MORE.
THANK YOU.
ALL RIGHT.
NEXT PLEASE RAISE YOUR HAND TO
VOTE NAY.
THANK YOU.
I SEE TWO HANDS.
PLEASE GO AHEAD AND LOWER THOSE
HANDS.
THANK YOU SO MUCH.
UP NEXT, PLEASE RAISE YOUR HAND
TO VOTE ABSTENTION.
NOT SEEING ANY HANDS, THIS
CONCLUDES THE VOTE.
THE MOTION AS STATED HAS PASSED.
>> THANK YOU, CHRISTINA.
GLEUSH BACK TO YOU.
>> THANK YOU ALL VERY MUCH.
SO THIS CONCLUDES THE CONCEPT
CLEARANCE PORTIONS OF OUR
AGENDA.
SO NOW I WANT TO PIVOT --
DR. JOHNSON, DID YOU WANT TO SAY
SOMETHING?
>> YEAH, HI.
I JUST REALIZED, ARE WE GOING TO
HAVE A CHANCE TO DISCUSS DSI
AFRICA?
THAT WAS ON OUR SLATE.
DID THAT JUST GET TABLED OR WHAT
HAPPENED WITH THAT?
>> THAT IS CURRENTLY TABLED, SO
IT IS NOT ON THE AGENDA FOR THIS
MONTH'S MEETING.
IT IS UNDER CONSIDERATION STILL
FOR THE MAY COUNCIL MEETING.
>> OKAY.
GREAT.
OKAY.
>> SO THE NEXT THING WE WANT TO
ADDRESS QUICKLY, I KNOW WE'RE
OVER TIME AND I APPRECIATE ALL
OF YOU SPENDING A FEW EXTRA
MINUTES WITH US, BUT WE WANT TO
HAVE SOME REFLECTIONS FROM OUR
DEPARTING COUNCILMEMBERS.
SO I WANT TO TAKE A MOMENT TO
EXTEND MY SINCERE GRATITUDE, BUT
REALLY ON BEHALF OF ALL OF
DPCPSI AND ALL OF NIH TO OUR
DEPARTING MEMBERS.
SO YOUR THOUGHTFUL GUIDANCE HAS
REALLY PLAYED A VITAL ROLE IN
HELPING NIH NAVIGATE COMPLEX
HEALTH CHALLENGES AND ADVANCE
SCIENTIFIC DISCOVERY.
WE ARE REALLY TRULY FORTUNATE TO
HAVE SUCH A DEDICATED GROUP OF
LEADERS HELPING TO SHAPE THE
FUTURE OF BIOMEDICAL AND
BEHAVIORAL RESEARCH.
SO ONCE AGAIN THANK YOU SO MUCH
FOR YOUR SERVICE, YOUR EXPERTISE
AND YOUR UNWAVERING COMMITMENT
TO THE NIH MISSION.
SO WE WANT TO ENSURE THAT OUR
DEPARTING COUNCILMEMBERS HAVE
THE OPPORTUNITY TO SHARE THEIR
INSIGHTS AND LEAVE US WITH SOME
PARTING WISDOM, IF THEY SO
CHOOSE.
SO PLEASE FEEL FREE TO COME OFF
MUTE TO SHARE YOUR THOUGHTS.
I KNOW THAT ONE OF OUR DEPARTING
MEMBERS, KRISTIN ARDLIE, HAD TO
JUMP OFF ALREADY, BUT IF LINDA
OR KEVIN OR RHONDA OR SUSAN OR
ANNA MARIA WOULD LIKE TO SAY A
FEW WORDS, WE WOULD WELCOME THAT
FEEDBACK.
KEVIN, PLEASE GO AHEAD.
>> THANK YOU.
I HAD SOME PREPARED REMARKS, I
THOUGHT I WOULD SAVE THEM.
SO AS I STEP DOWN FROM THIS
REMARKABLE COMMITTEE, I WANT TO
TAKE A MOMENT TO REFLECT NOT
JUST ON OUR SHARED WORK, BUT ON
THE PRINCIPLES THAT HAVE
ANCHORED MY CAREER AND MY
SERVICE HERE.
I BELIEVE DEEPLY IN THE
SCIENTIFIC PROCESS.
NOT AS A RIGID PROTOCOL BUT AS A
DYNAMIC ENGINE FOR TRUTH, DRIVEN
BY CURIOSITY, DISCIPLINE,
SKEPTICISM, AND CREATIVITY.
AND I'VE COME TO APPRECIATE MORE
THAN EVER THAT MEANINGFUL
INNOVATION EMERGES WHEN PEOPLE,
PROCESS AND TECHNOLOGY ARE
ALIGNED WITH INTENTION.
IT'S FROM THAT VANTAGE POINT
THAT I FEEL COMPELLED TO EXPRESS
SOME CONCERNS ABOUT THE PACE AND
DIRECTION OF RECENT CHANGES AT
THE NIH, OFTEN FRAMED AS
PROGRESS.
PROGRESS IS ESSENTIAL.
BUT IT IS NOT SUMMON MULLS WITH
SPEED.
PEOPLE REMAIN AT THE HEART OF
SCIENCE.
OUR TRAINEES WHO DEPEND ON
STABLE MENTORSHIP STRUCTURES,
OUR COMMUNITIES WHO DESERVE
CLEAR, TRUSTWORTHY SCIENCE
COMMUNICATION, OUR POLICYMAKERS
WHO RELY ON EVIDENCE TO INFORM
BOTH GLOBAL AND NATIONAL HEALTH
DECISIONS, OUR FELLOW
SCIENTISTS, WHOSE WORK IS
ENRICHED THROUGH DELIBERATION
AND COLLABORATION, NOT
DISRUPTION, AND US CITIZENS
WHOSE HELP IS THE LINCHPIN OF A
VIBRANT NATION.
LIKEWISE, PROCESS MATTERS.
NEW INITIATIVES, NO MATTER HOW
PROMISING, REQUIRE THOUGHTFUL
IMPLEMENTATION STRATEGIES,
INCLUSIVE ENGAGEMENT AND
ITERATIVE FEEDBACK LOOPS.
IT'S EASY TO PILOT AS WE TALKED
ABOUT EARLIER, IT'S MUCH HARDER
TO SUSTAIN.
THE SUCCESS OF NIH PROGRAMS WILL
HINGE NOT JUST ON VISION, BUT ON
SCAFFOLDING THAT PRESERVES
INSTITUTIONAL MEMORY AND REWARDS
LEARNING ALONG THE WAY.
AND TECHNOLOGY, WHILE EXCITING
AND MY THING, MUST BE APPROACHED
WITH A COMMITMENT TO VALIDATION.
WHETHER WE'RE TALKING ABOUT AI,
MHEALTH, NOVEL DIAGNOSTICS,
THESE TOOLS ARE ONLY AS GOOD AS
THE DATA THAT SHAPED THEM AND
THE RIGOR WITH WHICH THEY ARE
TESTED.
INNOVATION WITHOUT VIR F VERIFIN
CAN UNINTENTIONALLY WIDEN
DISPARITIES OR ERODE PUBLIC
TRUST.
SO TO MY FELLOW COUNCILMEMBER,
THANK YOU.
YOU ARE NOT ONLY AMONG THE MOST
PRE-EMINENT SCHOLARS IN YOUR
RESPECTIVE FIELDS, YOU'RE
GENEROUS, THOUGHTFUL AND
COLLEGIAL, MAKING EVERY MEETING
FEEL LIKE A MASTER CLASS IN
SCIENCE AND LEADERSHIP, IT'S
BEEN AN HONOR TO WORK ALONGSIDE
YOU.
TO THE INCREDIBLE NIH STAFF WHO
SUPPORT OUR WORK BEHIND THE
SCENES, YOU ARE THE UNSUNG
BACKBONE OF THIS ENTERPRISE.
THANK YOU GROWR TIRELESS
COORDINATION, YOUR ATTENTION TO
DETAIL AND YOUR GRACE UNDER
PRESSURE.
YOU ARE THE CATALYST OF THE
NIH'S MISSION TO CREATE NEW
KNOWLEDGE.
YOU MAKE THE WORK POSSIBLE AND
FRANKLY BETTER.
SO I LEAVE THIS COMMITTEE WITH
GRATITUDE, CONVICTION AND HOPE,
AND WL THE COMMIT TOMENT KEEP
CHAMPIONING THE VALUES THAT HAVE
MOVED SCIENCE FORWARD.
PEOPLE, PROCESS, INNOVATION,
TECHNOLOGY AND HARMONY.
THANK YOU.
>> THANK YOU SO MUCH, KEVIN.
RHONDA, PLEASE GO AHEAD.
>> THANK YOU.
I WANT TO ITERATE OR REPEAT MANY
THINGS THAT KEVIN HAS ALREADY
SAID, PARTICULARLY IN TERMS OF
THE EXCELLENT SUPPORT THAT WE
RECEIVE FROM THE STAFF AT NIH,
BUT ALSO MORE IMPORTANTLY, THE
COLLEGIAL RELATIONSHIP WITH
THOSE WHO ARE ON THE COUNCIL OF
COUNCIL.
NOT BEING A RESEARCHER OR AN
ACADEMIC MEDICINE, BUT IN WHAT I
WOULD CALL MORE HEALTHCARE
DELIVERY, YOU HAVE GIVEN ME THE
OPPORTUNITY TO LEARN SO MUCH IN
TERMS OF NOT ONLY SCIENCE,
INNOVATION, AND NEW IDEAS, BUT
ALSO UNDERSTANDING THE
COMPLEXITY AND THE COMPLICATIONS
IN TERMS OF TRYING TO BRING
THOSE SCIENTIFIC IDEAS FORWARD.
SO I THANK YOU FOR THAT.
IT HAS ALLOWED ME TO BECOME
HUMBLE TO THE COMPLEXITY AND THE
DIFFICULTY IN BRINGING THINGS
FORWARD.
A LOT OF MY EARLY WORK IN THE
FIELD HAD TO DO WITH CROSSING
THE QUALLY CHASM, I WAS ON THAT
COMMITTEE SO I HOLD VERY DEAR
THE ISSUE OF A TAKING 17 YEARS
TO TAKE A SCIENTIFIC FACT AND
GET IT INTO DELIVERY INTO THE
SYSTEM.
AND SO THAT'S ONE OF THE THINGS
THAT'S HIGHLY MOTIVATED ME AND I
WILL SAY THAT MANY OF THE THINGS
THAT I'VE HEARD HERE OVER THE
YEARS, OVER THE 12 YEARS I'VE
BEEN INVOLVED NOT ONLY FROM THE
MENTAL HEALTH PERSPECTIVE BULL
FROM THE GENERAL MEDICAL
PERSPECTIVE, HAVE ENCOURAGED ME
THAT NIH IS TRYING TO CLOSE THAT
GAP AND TRYING TO CLOSE THE
NUMBER OF YEARS THAT IT TAKES TO
DO THIS.
WITH THAT BEING SAID, I WOULD
SAY THERE ARE SOME THINGS THAT I
THINK NIH BEING IN THE POSITION
THAT YOU HAVE, PARTICULARLY
BEING UNDER THE GUISE OF
CONGRESS AND OTHERS, THAT YOU
HAVE THE CONNECTION TO BE ABLE
TO NAVIGATE THE REGULATORY
WATERS AND I THINK IT WAS
MENTIONED BY ONE OF THE LAST
SPEAKERS, BE ABLE TO USE THAT IN
ORDER TO BRING THE FIELD TO MOVE
TOGETHER, AND TO BEGIN TO ENGAGE
IN TERMS OF COMMITMENT.
I THINK THE ONE THING THAT WE
REALLY DON'T WANT IS TO CREATE,
PARTICULARLY IN THIS WORLD OF
NEW INNOVATIONS, IS
FRAGMENTATION THAT CAUSE MORE
PROBLEMS IN THE LONG RUN, AND
I'LL JUST CITE ELECTRONIC
MEDICAL RECORDS AS ONE OF THE
MAJOR ONES AS AN EXAMPLE FROM
THE VERY BEGINNING THAT BECAME
PRIVATIZED BUT CERTAINLY CREATED
A BUNCH OF FRAGMENTATION AND
COSTS ON THE PARTS OF HEALTH
SYSTEM.
SO THE MAJOR THINGS I WANT TO
SAY IS THAT SCIENCE IS AB
ABSOLUTELY SIGNIFICANT AND
ESSENTIAL, BUT IT HAS TO BE
TRUSTED SCIENCE.
AS I'VE MENTIONED EARLIER TODAY,
BEING ABLE TO COMMUNICATE THE
SCIENCE NOT ONLY TO THOSE WHO
CAN DIRECTLY USE IT, RPG BEYOND
THE WAYS THAT ARE BEING DONE
RIGHT NOW SO A WIDE
DISSEMINATION AND ACKNOWLEDGMENT
BUT ALSO TO THE PUBLIC, AND
BEING ABLE TO EXPLAIN TO THE
PUBLIC IN A WAY THAT WILL IT CAN
BE DIGESTED.
I WOULD ALSO SUGGEST THAT
PRIVATE SECTOR BE INVOLVED IN
TERMS OF HELPING YOU TO SHAPE
WHAT ARE THE AREAS THAT ARE MOST
IMPORTANT FROM THE PRIVATE
SECTOR PERSPECTIVE, THERE ARE
MANY PAIN POINTS THAT ARE OUT
THERE THAT CAN BE HELPED BY
ATTENTION BY NIH, PARTICULARLY
IN TERMS OF FURTHERING RESEARCH,
BUT MORE IMPORTANTLY, BRINGING
THAT RESEARCH IN TO THE REAL
WORLD SO THAT THERE IS IMMEDIATE
LEARNINGS THAT CAN OCCUR NOT
ONLY IN TERMS OF THE DATA THAT'S
COLLECT AND ANALYSIS BUT ALSO IN
TERMS OF DIRECTLY TO PROVIDERS
WHO ARE ENGAGED IN THIS AS WELL
AS THE PATIENTS.
I WOULD ALSO SAY THE AREA THAT I
THINK IS REAL IMPORTANT IS THE
GOVERNANCE.
AND THAT, I WOULD SAY YOU'RE
VERY GOOD AT PULLING TOGETHER
ALL YOUR DIVISIONS AND ALSO
PULLING IN MANY GOVERNMENTAL
ENTITIES, BUT I THINK IN ORDER
TO REALLY FURTHER WHAT YOU'RE
DOING IN BRINGING TO THE REAL
WORLD WITH ADOPTION AND
IMPLEMENTATION NEED TO AGAIN
BRING IN OTHER STAKEHOLDERS, I
WOULD CITE ONE OF THE AREAS THAT
IS REAL IMPORTANT IN TERMS OF
INNOVATION AND MOVING THINGS
FORWARD BESIDES THE RESEARCH AND
THE FUNDING THAT YOU BRING
FORWARD WOULD BE FUNDING THAT
COME FROM OTHER ORGANIZATIONS.
ALIGNMENT AROUND THOSE
ORGANIZATIONS, CONSOLIDATING OR
FOCUSING THEIR FUNDING, THEIR
PHILANTHROPIC FUNDING WILL BRING
MORE POWER TO THE SYSTEM TO BE
ABLE TO MAKE CHANGES IN ORDER TO
ACCOMMODATE THE RESEARCH THAT
YOU'VE GIVEN.
SO WITH THAT, WITH MY 12 YEARS
BEING HERE, AGAIN, I'M VERY
GRATEFUL FOR THE OPPORTUNITY.
I'VE LEARNED A LOT.
I'M SURE THERE'S MORE TO BE
LEARNED, AND I WILL CONTINUE TO
FOLLOW YOU ON THE WEB, BUT I
REALLY WANT TO SAY THAT IT'S
BEEN A FABULOUS OPPORTUNITY, AND
THANK YOU SO MUCH.
>> THANK YOU SO MUCH, RHONDA.
LINDA, PLEASE GO AHEAD.
>> HI.
I JUST ALSO WANT TO THANK --
EXPRESS MY GRATITUDE FOR -- AND
HONOR, I FELT VERY HONORED TO
HAVE BEEN PART OF THIS
COMMITTEE, AND TO BE ON THE
COUNCIL.
ALTHOUGH I SERVED ON THE NIDA
COUNCIL AND THE BSC, NIDA IN THE
PAST, I THINK BEING ON THIS
COMMITTEE, THIS COUNCIL REALLY
GAVE ME A MUCH BROADER
PERSPECTIVE OF HOW NIH
FUNCTIONED AND SO IT'S REALLY
BEEN A TREMENDOUS LEARNING
EXPERIENCE FOR ME, SO I'M VERY
GRATEFUL FOR THAT, AND THESE SIX
YEARS SEEM TO HAVE PASSED LIKE
THE BLINK OF AN EYE AND IT SEEMS
LIKE I THINK WE KIND OF MISSED
OUT A LITTLE BIT BECAUSE OF
COVID THAT WE DIDN'T HAVE AS
MANY IN-PERSON, WE HAD VERY FEW
IN-PERSON MEETINGS AS A RESULT
OF THAT, AND I THINK HAVING THE
IN-PERSON MEETING REALLY DOES
ADD VALUE TO THE COMMUNICATION
BETWEEN THE MEMBERS AND THE
DISCUSSION.
I DEFINITELY FELT THAT
ESPECIALLY EARLY ON DURING THE
PANDEMIC WHEN WE STARTED DOING
ALL THIS VIRTUAL MEETING,
EVERYTHING IS JUST, YOU KNOW, IT
WAS VERY MATTER OF FACT,
EVERYONE JUST REPORTS AND THE
DISCUSSION JUST WASN'T AS
ENGAGING AS THEY WERE, HAD WE
BEEN IN A IN-PERSON SETTING.
SO THAT'S MY ONLY FEEDBACK ABOUT
THAT, AND OTHERWISE I WANTED TO
THANK THE DPCPSI PROGRAM, THE
STAFF, EVERY, I'VE HAD A
WONDERFUL EXPERIENCE.
THANK YOU.
>> TH THANK YOU SO MUCH, LINDA.
OKAY.
I'M NOT SEEING ANY OTHER HANDS
RAISED.
I WILL NOTE THAT SUSAN PUT HER
COMMENTS IN THE CHAT.
SO I WILL JUST CLOSE BY SAYING,
YOU KNOW, I AM INCREDIBLY
GRATEFUL, BOTH ON BEHALF OF
DPCPSI AND NIH, BUT FOR MYSELF
PERSONALLY, BECAUSE THIS HAS
BEEN AN EXTRAORDINARILY HELPFUL
EXPERIENCE AS I LEARN MORE ABOUT
DPCPSI AND I JUST REALLY
APPRECIATE ALL OF THE THOUGHTFUL
INPUT AND CRITICAL DISCUSSION
AND CONSTRUCTIVE FEEDBACK THAT
WAS PROVIDED TODAY, AND I'M
REALLY LOOKING FORWARD TO GET
GETTING TO KNOW ALL OF YOU
BETTER, AND I HOPE THAT MANY OF
THE COUNCILMEMBERS WHO ARE
ROTATING OFF WILL STILL CONTINUE
TO REMAIN ENGAGED THROUGH OUR
WORKING GROUPS.
I THINK WE ALREADY HAD SOME
EXPRESSIONS OF COMMITMENT
EARLIER IN THE DAY FROM SOME OF
THOSE FOLKS, SO THAT'S
FANTASTIC.
I AM DELIGHTED TO INFORM YOU ALL
THAT THE NEXT COUNCIL OF
COUNCILS MEETING WILL BE IN
PERSON, AND IT IS SCHEDULED FOR
MAY 29TH AND 30TH, SO WE REALLY
LOOK FORWARD TO SEEING YOU NEXT
MONTH.
SO FRANZISKA, ANYTHING ELSE?
NO?
OKAY.
WHERE DID MY GAVEL GO?
OKAY.
THERE.
THE COUNCIL MEETING IS
ADJOURNED.
>> THANK YOU ALL.