>>THANK YOU FOR JOINING US AT
THIS AD HOC MEETING OF THE NIH
ADVISORY COMMITTEE TO THE
DIRECTOR.
WE REALLY APPRECIATE YOU TAKING
TIME OUT OF WHAT I'M SURE ARE
VERY BUSY SCHEDULES TO BE WITH
US TODAY, IN ADDITION TO THE
MEETING THAT WE HAVE SCHEDULED
IN DECEMBER.
WE HAD A SERIES OF VERY
IMPORTANT TOPICS TO DISCUSS IN
THE DECEMBER MEETING, AND
THOUGHT THAT THERE WOULD BE
BENEFIT IN PROVIDING YOU WITH A
PREVIEW OF THESE TOPICS THIS
EVENING, HENCE THIS SPECIAL AD
HOC MEETING.
AS A REMINDER, THE MEETING WILL
RUN FROM 5:00 P.M. TO 6:00 P.M.
TODAY, AND WILL BE RECORDED.
TO HELP US STAY ON TIME, I'VE
ASKED THE NIH ACTING PRINCIPAL
DEPUTY DIRECTOR, DR. TARA
SCHWETZ, TO MONITOR THE TIME.
SHE HAS A BELL, I GUESS, THAT
WILL BE USED AS A SIGNAL, AND
SHE WILL GO OVER A FEW
LOGISTICAL ITEMS FOR YOU.
TARA?
>>THANKS, LARRY.
I DON'T KNOW IF THE BELL WILL
WORK.
WE'LL TRY IT AND SEE.
SOMETIMES THE SOUND SORT OF
MUFFLES IT OUT, BUT HERE WE GO.
DID WE HEAR THAT?
>>NO.
>>OKAY.
SO WE'LL DO IT BY PINGING IN THE
CHAT.
THAT WILL BE THE APPROACH.
SO JUST A FEW REMINDERS FOR
FOLKS.
THE MEETING IS OPEN TO THE
PUBLIC, INCLUDING MEMBERS OF THE
PRESS AND IT IS BEING WEBCAST.
MEETING PRESENTATIONS AND ANY OF
THE SUPPLEMENTAL MATERIALS ARE
POSTED ON THE ACD -- OR WILL BE
POSTED ON THE ACD WEBSITE AFTER
THE MEETING.
AND THIS MEETING WAS ANNOUNCED
IN THE FEDERAL REGISTER ON
OCTOBER 26TH OF 2022.
OF NOTE, WE DID RECEIVE PUBLIC
COMMENT AND ACD MEMBERS CAN
REVIEW IT ON THE SHARE FILE SITE
AND YOU RECEIVED AN EMAIL ABOUT
THIS MAYBE ABOUT AN HOUR AGO OR
SO.
ACD MEMBERS AND PRESENTERS ARE
USING THE ZOOM APPLICATION TO
CONDUCT THE MEETING TODAY, AND
YOU CAN USE THE CHAT FEATURE TO
POSE QUESTIONS, AND MAKE A
COMMENT OR ASK A QUESTION.
AS I MENTIONED, I WILL PING THE
PRESENTERS WHEN TIME IS UP, SO
PLEASE MONITOR FOR THAT AS WELL.
NOW WHEN AN ACD MEMBER DOES WISH
TO MAKE A COMMENT, WE ASK THAT
YOU PLEASE RAISE YOUR DIGITAL
HAND AND TURN ON YOUR VIDEO AND
MIC SO THAT WE CAN SEE YOUR
FACE.
AND SO WE ARE RECORDING MORE
THAN JUST THE BOX WITH YOUR NAME
ON IT.
I'LL TURN IT BACK TO LARRY FOR
GOING THROUGH THE AGENDA TODAY.
>>OKAY, GREAT.
THANK YOU VERY MUCH, TARA.
SO I HAVE BEEN INFORMED THAT WE
HAVE A QUORUM.
BEFORE WE BEGIN OUR FIRST
PRESENTATION, I DID WANT TO
SHARE THAT CURRENT NIH ACD
MEMBERS NOW HAVE ACCESS TO THE
CENTER FOR SCIENTIFIC REVIEW'S
BIAS AWARENESS AND MITIGATION
AND TRAINING FOR REVIEWERS,
WHICH WAS LAUNCHED LAST FALL,
AND WE WILL SHARE THE
INFORMATION WITH THE ACD MEMBERS
ON HOW TO ACCESS THE TRAINING
AFTER THIS MEETING.
THIS EVENING, WE WILL HEAR
PRESENTATIONS FROM DR. NONI
BYRNES, DIRECTOR OF THE CENTER
FOR SCIENTIFIC REVIEW, ON A
PROPOSED NEW FRAMEWORK FOR PEER
REVIEW CRITERIA.
WE WILL THEN TURN TO DR. SHELLEY
BERGER, ACD MEMBER, AND
UNIVERSITY PROFESSOR AT
UNIVERSITY OF PENNSYLVANIA, AND
DR. TARA SCHWETZ, WHO YOU'VE
ALREADY HEARD FROM, ACTING
PRINCIPAL DEPUTY DIRECTOR AT
NIH, ON A PROPOSED ACD WORKING
GROUP ON POSTDOCS.
AND THEN FINALLY, A PRESENTATION
BY DRS. HOWARD CHANG, PROFESSOR
OF CANCER RESEARCH AND GENETICS
AT STANFORD, AND DR. LYRIC
JORGENSON, WHO IS THE ACTING
ASSOCIATE DIRECTOR FOR SCIENCE
POLICY AT NIH, AND THEN AT THE
VERY END, WE'LL JUST HAVE SOME
CLOSING REMARKS TO MAKE.
SO WITH THAT, I'M GOING TO TURN
IT BACK TO DR. SCHWETZ, WHO WILL
LEAD US THROUGH THE AGENDA.
SO THANKS.
>>THANKS, LARRY.
I'M GOING TO TURN IT OVER TO DRY
MENTIONED IS THE DIRECTOR OF THE
CENTER FOR SCIENTIFIC REVIEW
WHO'S GOING TO WALK THROUGH A
PROPOSED NEW FRAMEWORK FOR PEER
REVIEW CRITERIA.
SO NONI, TO YOU.
>>THANKS, TARA.
I JUST WANT TO SAY I CAN'T
REALLY SEE CHAT WHEN I'M IN
FULL SCREEN, SO IF YOU WANT TO
RING THE BELL, YOU CAN JUST
INTERRUPT.
WHILE I'M SPEAKING.
OKAY, THANK YOU, EVERYONE.
IT'S GREAT TO BE HERE.
AND I WANT TO SHARE WITH YOU A
PROPOSED FRAMEWORK FOR PEER
REVIEW CRITERIA THAT WAS
DEVELOPED BASED ON ADVICE FROM A
CSR ADVISORY COUNCIL WORKING
GROUP.
I'LL TELL YOU A LITTLE BIT MORE
ABOUT HOW THE DEVELOPMENT
OCCURRED, AND THEN WENT THROUGH
THE NIH PROCESS.
SO LET ME START WITH A
BACKGROUND.
IT'S JUST A REMINDER, WHICH I
THINK ALL OF YOU ARE QUITE
FAMILIAR WITH, WHICH IS THAT NIH
HAS A UNIQUE TWO-LEVEL PEER
REVIEW SYSTEM.
THE FIRST LEVEL IS AT THE STUDY
SECTION OR SEP AND THE SECOND
LEVEL OF REVIEW OCCURS AT THE IC
ADVISORY COUNCIL.
AND THE GOAL OF THE FIRST LEVEL
OF PEER REVIEW IS VERY SINGULAR.
IT'S TO PROVIDE EXPERT ADVICE TO
THE AGENCY ON THE SCIENTIFIC AND
TECHNICAL MERIT OF GRANT
APPLICATIONS.
SO WE HAVE TWO MAIN DRIVERS FOR
THINKING ABOUT PEER REVIEW
CRITERIA, AND THE WAY THIS WENT
IS, WE STARTED WITH THE FIRST
RATIONALE FOR LOOKING AT REVIEW
CRITERIA, AND THEN AS WE
GATHERED MORE INPUT INTO THE
PROCESS, THE SECOND ONE.
SO THE FIRST ONE IS EXPANSION OF
REVIEWER DUTIES THAT WENT BEYOND
THE GOALS OF THE FIRST-LEVEL
PEER REVIEW, AND THE SECOND
DRIVER IS REDUCING BIAS IN THE
PEER REVIEW PROCESS, AND THAT
SECOND ONE CAME ABOUT SORT OF AS
WE GATHERED INPUT INTO
RESTRUCTURING REVIEW.
SO LET'S START WITH THE FIRST
ONE.
WHAT DOES THAT MEAN?
SO TALKED ABOUT THE GOAL OF PEER
REVIEW, AND NIH VERY MUCH RELIES
ON THE EXPERTISE OF STUDY
SECTION TO IDENTIFY HIGH IMPACT
RESEARCH.
BUT OVER TIME, OVER THE LAST
DECADE, MORE THAN A DECADE,
INCREMENTALLY WITH GOOD
INTENTIONS, NIH SCIENTIFIC PEER
REVIEWERS HAVE BEEN ASKED TO
TAKE ON OTHER FUNCTIONS.
MORE ADMINISTRATIVE CHECKS,
THINGS THAT ARE IMPORTANT.
POLICY COMPLIANCE, CULTURE
CHANGE.
AND WE CAN TALK ABOUT WHETHER OR
NOT PEER REVIEW -- PEER REVIEW
ACTUALLY IS NOT A GOOD SYSTEM,
IT'S NOT SET UP TO DO THESE
KINDS OF REVIEWS, AND SO IT'S
NOT NECESSARILY GOOD FOR THE
NIH, BUT FROM THE REVIEWERS'
PERSPECTIVE, THERE ARE A COUPLE
OF CONSEQUENCES.
ONE IS REVIEWER BURDEN.
WE HAVE VOLUNTEER REVIEWERS, WE
RECRUIT THEM BASED ON THEIR
SCIENTIFIC EXPERTISE.
THEY HAVE -- THEY PREPARE EIGHT
TO 10 APPLICATIONS AND THEN THEY
HAVE AROUND 20 MINUTES AT THE
MEETING TO TELL US ABOUT WHAT
THEY THINK ABOUT THE SCIENCE AND
THE IMPACT.
AND THERE'S A CERTAIN LIMITATION
OF BANDWIDTH THAT OCCURS THAT
CAN AFFECT THE QUALITY OF THE
SCIENTIFIC INPUT BECAUSE OF ALL
THE OTHER DISTRACTIONS THAT
WE'RE ASKING THEM TO TAKE CARE.
THE OTHER PART RELATED TO THAT
IIS REVIEWER RECRUITMENT.
SO ONE THING THAT OUR STAFF HERE
IS -- REVIEWER SCIENTISTS LIKE
COMING AND TALKING ABOUT THE
SCIENCE AND GIVING -- BASICALLY
DOING THAT PART OF THE ROLE, BUT
THE ADMINISTRATIVE BURDEN CAN BE
A DISINCENTIVE TO SERVE.
SO WE KNOW OUR STAFF HAVE HEARD
THAT, I'VE HEARD IT.
AND NIH LEADERSHIP HAS HEARD IT.
AND EARLIER THIS YEAR, THERE WAS
AN EMAIL THAT'S JUST ONE EXAMPLE
OF THE KINDS OF FEEDBACK WE HEAR
RELATED TO BURDEN IN REVIEW.
AND THIS WAS SENT TO LARRY AND
COPIED TO ME, BUT YOU KNOW, IT
REALLY PUTS IT VERY WELL.
AND THIS, I'LL CALL YOUR
ATTENTION TO THIS LAST SENTENCE
HERE, "SHOULDN'T THE PRECIOUS
TIME OF VOLUNTEER REVIEWERS BE
FOCUSED ON THE CRITICAL
EVALUATION OF SCIENCE?"
SO THE SECOND PART OF OUR
RATIONALE WAS REDUCING BIAS, AND
WE HAVE -- WE'VE HEARD COMMUNITY
CONCERNS THROUGH THIS PROCESS,
THROUGH OTHER PROCESSES.
SO NIH AND CSR LEADERSHIP HAVE
HEARD COMMUNITY CONCERNS, AND
THE FOCUS MOSTLY IS ON
REPUTATIONAL BIAS IN PEER
REVIEW.
IF YOU'VE BEEN INVOLVED IN ANY
ASPECT IN PEER REVIEW, AS AN
APPLICANT, AS A REVIEWER, AS NIH
STAFF, YOU'VE SEEN THAT THIS
OCCURS IN STUDY SECTIONS.
SO WE'VE HEARD THIS FROM
SOLICITED FEEDBACK, SO WE HAD
BROAD SOLICITED FEEDBACK FOR
THIS SIMPLIFYING REVIEW PROCESS,
JUST ASKING THE COMMUNITY FOR
THEIR INPUT.
CSR RECENTLY RELEASED A
STRATEGIC PLAN AND WE WENT
THROUGH A FEEDBACK PROCESS
THERE.
AND WE HEARD THIS CONCERN COME
UP REPEATEDLY IN BOTH SETTINGS.
WE HEAR UNSOLICITED FEEDBACK,
JUST DIRECT COMMUNICATIONS THAT
COME TO LEADERSHIP, YOU KNOW,
FORMER MEMBER OR CURRENT MEMBER
OF THE ACD HAD RAISED THIS
CONCERN ABOUT INSTITUTIONAL BIAS
TO FRANCIS AND TO LARRY, AND
ACTUALLY WE ASKED HIM TO DO A
TESTIMONIAL IN THE CSR BIAS
TRAINING WHICH HE DID, WHICH I
THINK IS REALLY EFFECTIVE AND
MOVING, SO HOPE YOU HAVE A
CHANCE TO SEE THAT.
I'VE HAD FEEDBACK THROUGH
COUNCIL DISCUSSIONS I'VE HAD IN
OUR SUMMER CHAIR ORIENTATIONS,
THIS WAS RAISED AS A CONCERN.
THE CSR ADVISORY COUNCIL WORKING
GROUP THAT WOULD HE FORMED, SO
WE DO A LOT OF OUR INITIATIVES
THROUGH WORKING GROUPS, SORT OF
LIKE THE ACD WITH THE ADVISORY
COUNCIL WORKING GROUP TO GET
COMMUNITY INPUT, AND WE HAD SUCH
A WORKING GROUP WHICH IS PRETTY
DIVERSE PUT TOGETHER TO ADVISE
US ON DEVELOPING THE CONTENT FOR
THIS BIAS TRAINING THAT WAS
LAUNCHED LAST YEAR, AND THEY
ENDED UP ZEROING IN ON
REPUTATIONAL BIAS AS A MAJOR
SOURCE OF BYE-BYE AS IN PEER
REVIEW.
SO IN ADDITION TO FEEDBACK, THE
FEEDBACK THAT WE HEARD IS
ACTUALLY SUPPORTED BY SOME
STUDIES AND WE ARE TAKING
MULTIPRONGED ACTIONS, AND THIS
RESTRUCTURING OF PEER REVIEW IS
ONE OF THEM.
SO JUST A QUICK UPDATE ON THE
CSR ANONYMIZATION STUDY THAT I'M
SURE THIS GROUP IS FAMILIAR WITH
THAT WAS LAUNCHED MANY YEARS
AGO, IT WAS PUBLISHED LAST YEAR
AND THIS INVOLVED REDACTING THE
IDENTIFIERS OF PIs AND
INSTITUTIONS IN GRANT
APPLICATIONS.
SO THE BOTTOM LINE OF THE STUDY,
THE MAIN QUESTION WAS WHETHER
REDACTING IDENTIFIERS WOULD
IMPROVE THE SCORE OF BLACK
APPLICANT, IT DIDN'T DO THAT.
IT DID, HOWEVER, INTERESTINGLY,
WORSENED A SMALL EFFECT SIZE BUT
STILL SIGNIFICANT, WORSENED THE
SCORES FOR WHITE APPLICANTS,
WHICH MEANT THAT THERE WAS SOME
LEVEL OF A BUMP THAT WHITE
APPLICANTS WERE ENJOYING JUST
BASED ON THEIR NAME RECOGNITION
OR THE INSTITUTION THEY WERE IN.
AROUND 20% OF THE TIME,
REVIEWERS COULD IDENTIFY THE
APPLICANT, AND THAT, I THINK IS
NOT UNEXPECTED AND ONE OF THE
ISSUES WE HAVE WITH AN
ANONYMIZED REVIEW PROCESS IN
SCIENCE.
IT'S HARD TO ANONYMIZE BECAUSE
PEOPLE KNOW EACH OTHER AND WHAT
THEY'RE DOING.
SO WHAT DOES THIS MEAN?
DOES THIS MEAN WE CAN SORT OF
HANG IT UP, THERE'S NO BIAS?
DEFINITELY NOT.
THE TWO TAKEAWAYS THAT WE GOT
FROM THIS WAS THAT FIRST OF ALL
IT'S NOT SO EASY TO HAVE RACE AS
A SINGLE VARIABLE.
RACE IS VERY TIGHTLY LINKED TO
OTHER VARIABLES.
IT'S LINKED TO DISPARITIES AND
OPPORTUNITY AND ACCESS, AND SO
THAT'S SOMETHING WE NEED TO
THINK CAREFULLY ABOUT.
AND THE FINDINGS DO SUPPORT THE
IDEA THAT WE SHOULD EXAMINE
APPROACHES AND REVIEW THAT
DIMINISH THE ROLE OF P.I.
IDENTITY AND INSTITUTIONAL
IDENTITY.
AND JUST VERY QUICKLY,
RESTRUCTURING REVIEW CRITERIA IS
ONE ASPECT THAT I'LL BE TALKING
ABOUT TODAY AND THEN AGAIN IN
MORE DETAIL IN DECEMBER, BUT CSR
HAS A NUMBER OF CONCURRENT
INITIATIVES THAT WE'RE TACKLING
THIS FROM DIFFERENT ANGLES.
THE TRAINING, WE HAVE REPORTING
AVENUES WE'RE TRYING TO BROADEN
WITH SOME SUCCESS THE REVIEW
POOL AND WE'RE ALSO TRYING OUT
SOME ANONYMIZED REVIEW
PROCESSES.
SO WALK YOU THROUGH THE PROCESS.
IN JANUARY OF 2020, WE CONVENED
A CSR ADVISORY COUNCIL WORKING
GROUP ON SIMPLIFYING REVIEW.
AND AT THAT POINT, OUR FOCUS WAS
NOT NECESSARILY ON BIAS.
IT WAS JUST ON TRYING TO GET
REVIEW CRITERIA SIMPLIFIED AND
REDUCE BURDEN.
THE SCOPE WAS RPGs, RESEARCH
PROJECT GRANTS, WHICH IS MOST OF
WHAT CSR DOES.
THE GROUP WAS ASSEMBLED AND
DECIDED THAT THEY WOULD START
WITH THE NON-CLINICAL TRIALS,
WHICH ARE ABOUT 90% OF NIH
APPLICATIONS, BECAUSE CLINICAL
TRIALS ADD A LEVEL OF COMPLEXITY
AND THEY WANTED ADDITIONAL
EXPERTISE ON THE WORKING GROUP
FOR THAT.
WE OBTAINED GUIDANCE FROM OUR
OFFICE OF GENERAL COUNSEL
BECAUSE WE WANTED TO PROVIDE THE
WORKING GROUP WITH SOME
GUARDRAILS, WHAT THEY CAN AND
CAN'T DO.
AND WHAT THE GUIDANCE WE GOT IS
THAT THE FIVE REVIEW CRITERIA
THAT CURRENTLY EXISTS,
SIGNIFICANCE, INVESTIGATORS,
INNOVATION, APPROACH AND
ENVIRONMENT, ARE ALL DEFINED BY
THE PUBLIC HEALTH SERVICE CODE
OF FEDERAL REGULATIONS.
BUT NIH, THE AGENCY, HAS
DISCRETION ON HOW TO INTERPRET
THEM AND HOW TO GROUP THEM.
WE CAN'T CHANGE THE CRITERIA,
BUT WE CAN GROUP THEM THE WAY WE
WANT, AND WE CAN DECIDE TO SCORE
THEM OR NOT SCORE THEM AND WE
HAVE DISCRETION ON MATTERS OF
SCORING.
THIS IS JUST A SNAPSHOT OF THE
WORKING GROUP, AND YOU CAN SEE
HERE THAT WE HAVE MEMBERS FROM
OUR ADVISORY COUNCIL, WE HAVE --
THIS WAS CO-LED BY TANYA POLERMO
AND BRUCE REID FROM CENTER FROM
SCIENTIFIC REVIEW, AND MEMBERS
OF ADVISORY COUNCIL, AD HOC,
SOME PARTICIPATED IN JUST THE
NON-CLINICAL TRIALS, SOME IN
CLINICAL TRIALS AND SOME IN BOTH
GROUPS.
SO THE PROCESS, WE STARTED OFF
BY GETTING INPUT.
WE PUT THIS OUT ON A REVIEW BLOG
THAT HAS ABOUT A HUNDRED
THOUSAND SUBSCRIBERS, IT WAS PUT
ON OPEN MIC BLOG THAT HAS
350,000 SUBSCRIBERS.
THE CSR BLOG ALONE GOT MORE THAN
9,000 PAGE VIEWS, WE GOT MORE
THAN 400 COMMENTS.
WE DID A CONTENT ANALYSIS AND WE
PROVIDED THIS TO THE WORKING
GROUPS, WHICH AS YOU WILL SEE,
THEY REALLY TOOK -- THEY AGREED
WITH MANY OF THE MAJOR THEMES
THAT EMERGED AND THEIR
RECOMMENDATIONS ARE SORT OF
ALIGNED WITH WHAT WE HEARD.
JUST BROADLY, THE MAIN THEMES OF
THE CONTENT ANALYSIS WERE PEOPLE
WERE CONFUSED ABOUT INNOVATION,
THEY DIDN'T KNOW HOW TO ASSESS
IT, WHETHER IT'S TECHNICAL,
CONCEPTUAL, WHAT TO DO ABOUT
INNOVATION OF REALLY IMPORTANT
PROJECTS THAT ARE NOT REALLY
THAT INNOVATIVE BUT IMPORTANT TO
DO.
INVESTIGATOR/ENVIRONMENT, WE
TALKED ABOUT THAT.
AND ADDITIONAL REVIEW
CONSIDERATIONS, SUGGESTED TO
MOVE TO ADMINISTRATIVE REVIEW,
AND EMPHASIS ON FEASIBILITY AND
RIGOR.
SO THE EXTERNAL INPUT GATHERING
AND THE PROCESS, IT WAS STARTED
IN JANUARY, SEVEN VIRTUAL
MEETINGS WERE HELD BY THE
NON-CLINICAL TRIALS WORKING
GROUP.
AN INTERIM REPORT WAS PRESENTED
AND IT WAS DISCUSSED BY THE FULL
ADVISORY COUNCIL THAT WAS
SUPPORTIVE AND HAD SOME
SUGGESTIONS.
WE TOOK A BREAK FOR THE
PANDEMIC, JUST TO REGROUP AND
CONTINUE TO HOLD PEER REVIEW
MEETINGS, BUT THEN WE REGROUPED
IN SEPTEMBER 2021 WHERE THE
CLINICAL TRIALS WORKING GROUP
HAD FOUR VIRTUAL MEETINGS AND
THEN A COMBINED SET OF
RECOMMENDATIONS WERE PRESENTED
IN MARCH 2021, AND WERE APPROVED
BY THE FULL CSR ADVISORY
COUNCIL.
THE FINAL REPORT OF THIS WAS
POSTED ON OUR WEBSITE.
AT THAT POINT, THE PROCESS MOVED
INTERNAL TO NIH, SO WE TOOK
THOSE RECOMMENDATIONS TO A
TRANS-NIH EXTRAMURAL ACTIVITIES
WORKING GROUP THAT'S ADVISORY TO
THE STEERING COMMITTEE OF NIH,
WHICH FORMED A COMMITTEE TO SORT
OF LOOK THROUGH DEEPLY AT ALL OF
THE RECOMMENDATIONS AND DEVELOP
AND MODIFY THOSE TO BE PRACTICAL
AND TO ADDRESS THE ISSUES THAT
WE THOUGHT NEEDED TO BE
ADDRESSED.
I HAVE PROVIDED A COUPLE OF
UPDATES, STATUS UPDATES AT
PUBLIC ADVISORY COUNCIL
MEETINGS, AS WE'VE GONE ALONG
BECAUSE OUR ADVISORY COUNCIL IS
VERY INVESTED IN THIS AND WANTS
TO KNOW, BUT WE HAVEN'T
ACTUALLY -- THIS IS THE FIRST
TIME WE'RE GOING TO BE
PRESENTING THE NIH MODIFICATIONS
TO WHAT WAS PROPOSED BY THE
ADVISORY COUNCIL.
SO NIH IN APRIL 2022 PROPOSED
SOME MODIFICATIONS.
THOSE WERE PRESENTED INTERNALLY
TO NIH LEADERSHIP, AND THEY
APPROVED THE THREE-FACTOR
FRAMEWORK THAT I'M GOING TO TALK
TO YOU ABOUT.
SO THE MAJOR RECOMMENDATIONS OF
THE EXTERNAL ADVISORY GROUP FOR
THE NEW PEER REVIEW FRAMEWORK
WERE THIS: FIRST, REORGANIZE
THE CURRENT FIVE SCORED REVIEW
CRITERIA INTO THREE FACTORS THAT
ADDRESS THE THREE QUESTIONS:
SHOULD IT BE DONE, CAN IT BE
DONE, WILL IT BE DONE?
SO FACTOR ONE WAS IMPORTANCE OF
THE RESEARCH UNDER THAT FALL THE
TWO REQUIRED CRITERIA,
SIGNIFICANCE, INNOVATION.
FACTOR TWO WAS FEASIBILITY AND
RIGOR, WHICH IS APPROACH.
AND THEN FACTOR THREE WAS
INVESTIGATOR AND ENVIRONMENT.
THEY ALSO RECOMMENDED THAT MOST
ADDITIONAL REVIEW CRITERIA,
THESE ARE LIKE HUMAN SUBJECTS,
VERTEBRATE ANIMALS THAT HAVE AN
IMPACT ON THE SCORE, REMAIN
UNCHANGED.
THEY DID SUGGEST THAT MOST
REVIEW CONSIDERATIONS, THESE ARE
THINGS THAT DO NOT AFFECT SCORE,
BUT PEER REVIEW HAS BEEN ASKED
TO WEIGH IN ON, THEY DID SUGGEST
THAT THOSE BE REMOVED FROM THE
FIRST LEVEL OF PEER REVIEW.
THERE IS A DETAILED REPORT,
WHICH HAS BEEN PROVIDED TO YOU,
I THINK, AND HAS ALL OF THE
DETAILED RECOMMENDATIONS.
SO FOR NIH, THIS HAPPENED
AROUND, I DON'T KNOW, SUMMER OF
2020 AND BEYOND THAT, AND WE
WERE GETTING A LOT OF FEEDBACK
ABOUT HOW BIAS COMES INTO THE
REVIEW PROCESS AND HOW TIGHTLY
IT'S LINKED TO RACIAL
DISPARITIES AND OTHERS.
AND WE WERE LOOKING CAREFULLY AT
WHERE BIAS COMES IN TO THE
REVIEW PROCESS.
THIS WAS AN OPPORTUNITY FOR US,
AS WE WERE RESTRUCTURING REVIEW
CRITERIA, TO THINK ABOUT THAT.
THE OTHER THING WE WERE
THINKING -- THAT AS PART OF
DEVELOPING BIAS TRAINING, WE
LOOKED AT LITERATURE IN
EVALUATIONS FROM MULTIPLE
DIFFERENT FIELDS, AND ONE THING
THAT'S CLEAR FROM ALL FIELDS IS
THAT THE MORE SPECIFIC YOU MAKE
THE REVIEW CRITERIA AND THE MORE
YOU MAKE THE EVALUATORS BE
SPECIFIC, THE LESS BIAS YOU'LL
HAVE IN THE EVALUATION.
AND FOR RPGs, WHICH ARE
RESEARCH PROJECT GRANTS, WHAT
WE'RE TRYING TO DO IS HAVE
INVESTIGATOR AND ENVIRONMENT
EVALUATED IN THE CONTEXT OF THE
PROJECT, RIGHT?
THIS IS NOT ABOUT THE
INVESTIGATOR'S PEDIGREE OR
RECOGNITION FACTOR OR
REPUTATION.
THIS IS ENTIRELY RELATED TO THE
PROJECT.
DOES THE INVESTIGATOR HAVE THE
TRAINING AND EXPERTISE TO DO THE
PROJECT?
SAME WITH RESOURCES FOR THE
ENVIRONMENT.
IT'S NOT ABOUT THE PRESTIGE OF
THE INSTITUTION, BUT RATHER THE
RESOURCES PRESENT TO COMPLETE
THE PROJECT.
BUT THE WAY THE REVIEW CRITERIA
ARE STRUCTURED RIGHT NOW, WHICH
IS -- THERE'S A SCORE FROM 1 TO
9 FOR INVESTIGATOR, ENVIRONMENT,
YOU CAN WRITE BULLETED STRENGTHS
AND WEAKNESSES BUT IT'S
BASICALLY OPEN-ENDED NARRATIVE.
THAT GIVES REVIEWERS LATITUDE,
RIGHT?
IF IT'S NOT SPECIFIC, IT DOESN'T
FORCE PEOPLE INTO REALLY NAILING
DOWN THE SPECIFICS OF WHAT
CONCERNS THERE ARE.
SO WE END UP SEEING THINGS LIKE,
YOU KNOW, FAINT PRAISE FOR AN
INSTITUTION THAT'S NOT WELL
RECOGNIZED OR NOT WELL
RESOURCED.
IT'S FINE FOR AN HBCU, BUT FOR
HARVARD, IT'S THE BEST THING
EVER.
YOU KNOW, OR DR. X IS A LEADER
IN THE FIELD AND HAS MADE
SEVERAL CONTRIBUTIONS.
AND DR. Y SEEMS TO HAVE THE
EXPERTISE AND A SCORE OF A
4 WITHOUT MUCH EXPLANATION AS TO
WHY THAT'S A 4.
SO THE NEW REVIEW FRAMEWORK AND
THE NIH PROPOSED MODIFICATIONS
TO WHAT THE ADVISORY COUNCIL
PROPOSED, CENTER MOSTLY AROUND
FACTOR THREE.
THERE ARE SOME, YOU KNOW,
CHANGES TO WORDING AND SUCH IN
FACTORS ONE AND TWO, BUT THE
MAJOR CHANGE IS TO FACTOR THREE.
WHICH NIH HAS PROPOSED BE
RENAMED EXPERTISE AND RESOURCES,
UNDER WHICH FALL INVESTIGATOR
AND ENVIRONMENT, AND THAT FACTOR
ITSELF NOT RECEIVE A SCORE, BUT
IT DOES COUNT TOWARD THE OVERALL
IMPACT SCORE.
IT BEEN CHANGED TO -- WE'RE
PROPOSING A CHANGE TO A
DROPDOWN.
WHAT THAT MEANS IS, DOES THE
INVESTIGATOR HAVE THE EXPERTISE
AND TRAINING, IF YOU THINK
THAT'S APPROPRIATE FOR THE
PROJECT.
APPROPRIATE, YOU DON'T HAVE TO
WRITE ANYTHING.
IF YOU DON'T THINK -- IF THERE'S
SOME GAPS WHICH SHOULD BE
IDENTIFIED, THEN THOSE NEED TO
BE EXPLICITLY MENTIONED, IT
SHOULD AFFECT THE OVERALL IMPACT
SCORE.
SO THIS IS A PRETTY MAJOR CHANGE
TO FACTOR THREE, AND THERE ARE
SOME OTHER CHANGES TO THE
ADDITIONAL REVIEW CRITERIA AS
WELL.
SO THE NEXT STEPS ARE -- WE HAVE
A COUPLE OF ONGOING EFFORTS THAT
ARE WINDING DOWN, WHICH IS WE
HAVE A TRANS-NIH COMMITTEE
THAT'S LOOKING AT INCORPORATING
RIGOROUS REVIEW OF CLINICAL
TRIALS INTO THE PROPOSED
FRAMEWORK.
SO CLINICAL TRIAL RPGs INTO
THE PROPOSED FRAMEWORK.
AND THEN THE BRAIN INITIATIVE
HAS A PLAN TO ENHANCE DIVERSE
PERSPECTIVES THAT THEY'RE USING
IN ALL OF THEIR INITIATIVES, AND
WE'RE TRYING TO SEE HOW WE CAN
INCORPORATE THAT INTO SORT OF
THE BROADER RPG FRAMEWORK.
SO THE NEXT STEPS ARE PUBLIC --
OR THIS IS STEP ONE OF THE
PUBLIC ROLLOUT, SO THE CHANGE TO
FACTOR THREE AND NIH PUSH
MODIFICATIONS HAVEN'T YET
PUBLICLY BEEN DISCUSSED SO ACD
IS THE FIRST TIME WE'RE
DISCUSSING WITH THE PUBLIC AND
WOULD LIKE TO HEAR YOUR INPUT.
WE ARE GOING TO ISSUE AN RFI IN
THE NOVEMBER/DECEMBER TIME FRAME
AND THEN WE EXPECT TO HAVE A
FULLER DISCUSSION AT THE
DECEMBER ACD.
AND JUST FOR YOUR AWARENESS, WE
JUST COMPLETED A CSR ADVISORY
COUNCIL WORKING GROUP THAT WAS
LOOKING AT NRSA FELLOWSHIP
REVIEW CRITERIA, AND THEY HAVE
ISSUED SOME RECOMMENDATIONS THAT
ARE AVAILABLE THAT THOSE ARE
UNDER CONSIDERATION BY THE NIH
RIGHT NOW.
SO I'LL STOP SHARING.
HAPPY TO TAKE QUESTIONS.
>>THANKS, NONI.
IF FOLKS HAVE QUESTIONS, PLEASE
RAISE YOUR HAND AND WE'LL -- WE
HAVE TIME FOR A COUPLE.
REMEMBER, THIS IS GOING TO BE
PRESENTED IN MORE DETAIL IN
DECEMBER, AND THERE WILL BE
AMPLE TIME FOR DISCUSSION THEN.
IF THERE ARE SOME QUESTIONS,
HAPPY TO HAVE A BIT OF A
CONVERSATION.
I DO SEE SOME CAMERAS THAT HAVE
TURNED ON BUT I DON'T SEE ANY
HANDS RAISED JUST YET.
ROBI, YOU HAVE YOUR HAND UP?
>>THE QUESTION I HAVE ARE WHAT
ARE THE METRICS OF SUCCESS FOR
THIS ASSESSMENT AND POTENTIAL
CHANGE IN PEER REVIEW?
>>SO THAT'S A GOOD QUESTION,
AND IT'S A QUESTION FOR EVERY
INITIATIVE THAT WE UNDERTAKE.
I THINK THE ULTIMATE OUTCOMES OF
PEER REVIEW IS WHO GETS THROUGH
PEER REVIEW, WHAT KINDS OF
SCORING OCCURS FOR THAT FACTOR
THREE FOR INVESTIGATORS.
BECAUSE CURRENTLY WE HAVE -- WE
HAVE SOME DATA ON INVESTIGATOR
AND ENVIRONMENT SCORING, AND
WHEN THERE'S DISCREPANCIES THAT
AREN'T FULLY EXPLAINED.
SO I THINK IT WOULD BE MORE
ANALYSIS OF THE CRITERIA, AND
WHAT BASIS PEOPLE ARE ASSESSING
THOSE ON.
I THINK REMOVING THE SCORE FROM
THE CRITERIA, REMEMBER, 10, 15
YEARS AGO, THERE WAS NO SCORE
FOR ANY CRITERIA.
THEN WE ADDED CRITERIA SCORES
FOR INVESTIGATOR AND
ENVIRONMENT.
AND THAT'S BECOME A BIT
PROBLEMATIC, BECAUSE -- AND
THAT'S OUR DATA FROM JUST
LOOKING AT SCORING AND WHICH
INSTITUTIONS IT COMES FROM.
SO I THINK ULTIMATELY IT'S
OUTCOMES OF PEER REVIEW, YOU
KNOW, WHO'S BEING SUCCESSFUL
COMING OUT OF PEER REVIEW AND
HOW MUCH THAT'S RELATED TO WHERE
THEY'RE COMING FROM.
ONE OF THE CONCERNS WE HEARD WAS
UNDERRESOURCED -- ACTUALLY NOT
EVEN UNDERRESOURCED, BUT MIDDLE
OF THE COUNTRY INSTITUTIONS,
WHERE THE SAME INDIVIDUAL MIGHT
BE -- WAS AT ONE OF THE IVIES ON
THE EAST COAST, MOVED TO THE
MIDDLE OF THE COUNTRY AND HIS
INVESTIGATOR SCORE WENT DOWN,
HIS INSTITUTIONAL WENT SCORE AND
HIS OVERALL IMPACT SCORE WENT
DOWN.
PRETTY MUCH THE SAME RESEARCH.
SO I THINK WE HAVE TO LOOK AT
OUTCOMES IN A MORE SYSTEMATIC
WAY.
>>ANY OTHER QUESTIONS?
GARTH, I SEE YOU RAISED YOUR
ACTUAL HAND FIRST AND ATUL, YOU
HAVE YOUR HAND UP.
GARTH, DID YOU WANT TO ASK YOUR
QUESTION?
WE CAN'T HEAR YOU.
OKAY, WE'LL GO TO ATUL FIRST AND
MAYBE BY THAT TIME, WE GET
THROUGH WITH THAT, THEN YOUR
AUDIO WILL BE FIGURED OUT.
ATUL?
>>SO OBVIOUSLY I CAN IMAGINE
WHERE MOST OF THE RFI COMMENTS
WILL BE COMING FROM, BUT WHAT'S
THE PROCESS GOING TO HAPPEN FOR
K AWARDS, FOR SBIRs, SO THOSE
WOULD HAPPEN AFTER RPGs ARE
SETTLED?
WHAT WOULD HAPPEN NEXT?
>>THANK YOU.
THANKS FOR THAT QUESTION.
WE'RE FOCUSED RIGHT NOW ON
RPGs.
WE'LL SEE WHAT COMES FROM THE
RFI, SEE IF WE NEED TO MAKE ANY
MODIFICATIONS.
AND THEN GO TO THE NEXT STEP.
AND I THINK THE K AWARDS ARE
ACTUALLY MORE LINKED TO
FELLOWSHIP AND WHAT WE LEARN
FROM THE FELLOWSHIP PROCESS
THAT'S -- AND COMING UP NEXT.
>>GARTH, DO WE WANT TO TRY TO
GO BACK?
OKAY, WE STILL -- I STILL CAN'T
HEAR YOU.
WELL, WE'LL DEFINITELY HAVE TIME
TO ASK YOUR QUESTION IN
DECEMBER, SO IF YOU CAN DO THAT.
OR IF YOU CAN PUT IT IN THE
CHAT, WE CAN SEE ABOUT GETTING
THAT ADDRESSED.
WELL, IF THERE ARE NO MORE
QUESTIONS, WE WILL MOVE ON.
WE ARE MAYBE 30 SECONDS AHEAD OF
SCHEDULE HERE.
SO IMPRESSIVE.
SO SHIFTING TO THE NEXT ITEM,
AND THANK YOU SO MUCH, NONI, FOR
THAT PRESENTATION, AND LOOK
FORWARD TO MORE DISCUSSION IN
DECEMBER.
MOVING ON TO THE NEXT TOPIC, WE
ARE GOING TO DISCUSS A PROPOSED
ACD WORKING GROUP THAT SHELLEY
AND I ARE GOING TO BE DESCRIBING
A LITTLE BIT MORE TO YOU ALL
HERE SHORTLY.
AND SO I'M GOING TO START THE
PRESENTATION, AND THEN I'M GOING
TO TURN IT OVER TO SHELLEY HERE
IN A FEW MINUTES.
BUT WE'RE GOING TO SHARE WITH
YOU SOME REALLY PRELIMINARY
THOUGHTS ON ESTABLISHING AN ACD
WORKING GROUP THAT WILL ADDRESS
NIH SUPPORTED POSTDOCTORAL
TRAINING AND SOME OF THE
CHALLENGES RELATED TO THIS TOPIC
IN THE BIOMEDICAL ECOSYSTEM.
SO IF WE COULD GO TO THE NEXT
SLIDE.
IN PARTICULAR, THERE ARE
CONCERNS ABOUT A DECLINE,
SOMETIMES I HEAR PEOPLE TALK
ABOUT IT AS A SHORTAGE OF
POSTDOCS.
BUT THIS CHALLENGE SEEMS TO HAVE
BEEN BREWING FOR A LITTLE BIT OF
TIME, AND WHAT WE HAVE SEEN IS
PUBLICATIONS GOING BACK 10 OR SO
YEARS THAT INDICATE THAT THERE
ARE CHALLENGES WITH THE
POSTDOCTORAL TRAINEE PROCESS AND
THE NUMBER OF POSTDOCS THAT ARE
ENTERING INTO THAT CAREER ROUTE.
SO THIS ISSUE ISN'T NEW.
BUT IT'S SOMETHING THAT SEEMS TO
BE BUBBLING UP A LOT LATELY, AND
IN FACT, I JUST HEARD THIS THE
OTHER DAY FROM A COUPLE OF
INDIVIDUALS WHO LEAD SIGNIFICANT
SCIENTIFIC ORGANIZATIONS, THEIR
GROWING CONCERN ABOUT THIS AREA.
AND THERE'S A SENSE AT LEAST
ANECDOTALLY THAT THE CHALLENGE
SEEMS TO BE GROWING, AND THERE
IS SOME DATA TO SUPPORT THIS,
BUT THAT WAS THE ORIGINAL
QUESTION, DID THE DATA ACTUALLY
BEAR THIS OUT.
IF YOU GO TO THE NEXT SLIDE.
SO WE'RE JUST GOING TO SCRATCH
THE SURFACE TO BEGIN TO TALK
ABOUT THIS HERE TODAY, BUT I'LL
BRIEFLY PROVIDE SOME BACKGROUND
DATA FOR CONTEXT.
AS MANY OF YOU KNOW, NSF
COLLECTS DATA ON POSTDOCS AND
CONDUCTS AN ANNUAL CENSUS OF ALL
U.S. ACADEMIC INSTITUTIONS ON
GRANT RESEARCH-BASED MASTERS AND
DOCTORAL DEGREES IN SCIENCE AND
ENGINEERING, AND SELECTED HEALTH
FIELDS AS WELL.
AND NIH ACTUALLY IS A CO-SPONSOR
OF THIS WORK.
AND BASED ON SOME OF THE DATA
THAT THEY HAVE AVAILABLE, YOU
CAN SEE HERE THAT THE NUMBER OF
POSTDOCS WHICH ARE REPRESENTED
BY THE GREEN LINE AND THE NUMBER
OF NON-FACULTY RESEARCHERS WITH
DOCTORATES ARE REPRESENTED IN
THE BLUE LINE, AND I SHOULD NOTE
THAT THESE NFRs, AS THEY ARE
REFERRED TO, THESE NON-FACULTY
RESEARCHERS WITH DOCTORATES, ARE
FOLKS THAT ARE DOCTORATE-HOLDING
STAFF WHO ARE NEITHER POSTDOCS
NOR FACULTY AND ARE PRIMARILY
INVOLVED IN RESEARCH.
BUT YOU CAN SEE HERE THAT THE
NUMBER OF POSTDOCS HAS STEADILY
INCREASED AS A FUNCTION OF TIME
SINCE 1980.
BUT OVER THE LAST DECADE OR SO,
IT'S REMAINED LARGELY FLAT.
AND IMPORTANTLY, I'LL NOTE THAT
THESE NSF DATA WILL BE UPDATED
LATER THIS YEAR, IN DECEMBER,
AND I THINK IT'S GOING TO GIVE
US A REALLY IMPORTANT GLIMPSE
INTO THE IMPACT OF THE PANDEMIC
ON THE POSTDOC WORKFORCE.
WE'LL CONTINUE TO GO TO THE NEXT
SLIDE.
SO IF WE LOOK AT OUR INTERNAL
NIH DATA, YOU CAN SEE THE TRENDS
IN POSTDOCS ON TRAINING GRANTS
AND FELLOWSHIPS HAS STEADILY
DECREASED OVER TIME.
I WILL NOTE THAT WE SEE SORT OF
PARALLELS WHEN YOU LOOK AT THE
NUMBER OF APPLICATIONS FOR THE
F32s.
BECAUSE WE'RE SEEING A SORT OF
SIMILAR DECREASING TREND.
BUT IT'S INTERESTING TO NOTE
THAT THE STIPENDS HAVE ACTUALLY
STEADILY BEEN GROWING OVER THE
LAST 10 OR SO YEARS AND ARE NOW
UP TO ABOUT $55,000 FOR SOMEONE
THAT'S JUST STARTING OUT AS A
POSTDOC, MUCH BETTER THAN WHEN I
STARTED AS A POSTDOC.
BUT YOU KNOW, IN INDUSTRY, THE
NATIONAL AVERAGE IS ABOUT
$20,000 HIGHER, AND THAT'S A
REALLY SIGNIFICANT SALARY
DIFFERENCE THAT WE THINK IS ONE
COMPONENT THAT IS A FACTOR HERE.
IF YOU GO TO THE NEXT SLIDE.
IF YOU LOOK AT WHERE PEOPLE ARE
GOING RIGHT OUT OF GRAD SCHOOL,
WHAT YOU CAN SEE IS THERE IS AN
INCREASING PERCENTAGE OF NEW
PH.D.s THAT ARE GOING INTO
INDUSTRY OR BUSINESS.
IN 2021, LAST YEAR, IT WAS ABOUT
57%.
WHILE ONLY ABOUT 26% A QUARTER
PURSUED CAREERS IN ACADEMIA.
I WANT TO BE CLEAR TO EMPHASIZE
THAT A DISTRIBUTION OF SCIENCE
AND ENGINEERING DOCTORAL
RECIPIENTS GOING INTO A RANGE OF
FIELDS IS A REALLY GOOD THING,
BUT I THINK WE RECOGNIZE THAT
THESE DATA SHOW THAT THERE ARE
TRENDS THAT WARRANT US
CONSIDERING ALL OF THE FACTORS
THAT ARE INFLUENCING PEOPLE'S
DECISION-MAKING AND CONSIDERING
HOW WE MIGHT THINK ABOUT THE
POSTDOCTORAL PATHWAY.
SO NOW I'M GOING TO TURN IT OVER
TO SHELLEY, WHO'S GOING TO SPEAK
MORE ABOUT THIS.
SHELLEY?
>>OKAY, GREAT.
THANK YOU, TARA.
NEXT SLIDE, PLEASE.
SO TARA TOUCHED ON A FEW OF
THESE ISSUES ALREADY.
IT SEEMS IN TAKING A LOOK AT
THIS, YOU KNOW, QUESTION THAT
IT'S MULTIFACTORIAL, AND I THINK
A QUESTION THAT WE NEED TO POSE
IS WHETHER THERE'S AN ONGOING
CHANGE IN THE TRAJECTORY OF
GRADUATE STUDENT DECISIONS.
SO WHAT'S PLAYING INTO THAT, IT
SEEMS LIKE IT'S A PERFECT STORM.
I THINK THOSE ARE THE WORDS THAT
HAVE BEEN USED BY ACTUALLY MANY
OF THOSE ARTICLES AND OPINION
PIECES AND OTHER ARTICLES THAT
HAVE BEEN WRITTEN THAT TARA
SHOWED AT THE BEGINNING, SORT OF
REFERRED TO AS A PERFECT STORM,
PROBABLY BROUGHT TO -- IT'S
PROBABLY REACHING MORE OF A
REALLY DRAMATIC DEVELOPMENT, I
THINK, IT APPEARS, WITH THE
CORONAVIRUS, BUT IT'S SOMETHING
THAT'S BEEN DEVELOPING ON -- IT
SOMETHING THAT I THINK MANY OF
US ARE INCREASINGLY HEARING FROM
OUR GRADUATE STUDENTS ABOUT
WORK/LIFE BALANCE AND OVER THERE
ON THE RIGHT, AND IT PLAYS INTO
THE QUESTION OF FINANCIAL
DECISIONS, AND OF COURSE WE ALL
KNOW THAT THIS TIME OF LIFE IS A
CRITICAL TIME FOR MANY PEOPLE,
THEY'RE GETTING MARRIED STARTING
FAMILIES AND SO THIS BECOMES A
REALLY BIG CHALLENGE.
AND I THINK THAT PLAYING INTO
THAT IS THE EXTENDING TIME I
THINK MANY OF US DOCUMENT, AND
WE'LL SEE THIS, I THINK, IN THE
DATA, OR WE'RE GOING TO QUESTION
THIS IN THE DATA, WHETHER THE
TIME DURING GRAD SCHOOL HAS BEEN
INCREASING AND THUS EXACERBATING
THIS PROBLEM, THIS WORK/LIFE
BALANCE QUESTION IS REALLY
DEVELOPING.
AND THEN AT THE BOTTOM, THE
GLOBAL DIAGRAM IS REFERRING TO
SOME OF THE CHANGES THAT HAVE
BEEN EMERGING, HAVE BEEN
STARTING TO EMERGE AND
EXACERBATED AGAIN BY THE
CORONAVIRUS, WHERE THERE ARE
FEWER INTERNATIONAL POSTDOCS
THAT ARE COMING TOWARDS THE
UNITED STATES.
AND I THINK THAT'S ALSO, YOU
KNOW, ONE POSSIBILITY THAT WE'LL
LOOK INTO, IS WHETHER THE LEVEL
OF SCIENCE IS ACTUALLY
IMPROVING, I THINK, IN OTHER
PARTS OF THE WORLD, I THINK WE
KIND OF NEED TO LOOK AT THAT,
AND THE HOME-GROWN TALENT, THE
RETURN OF POSTDOCS FROM THE
UNITED STATES TO THEIR HOME
COUNTRIES AND DEVELOPING SCIENCE
THERE.
WHICH IS A GOOD THING.
I MEAN, I THINK THE UNITED
STATES HAS BEEN A REAL BEACON OF
TRAINING, AND SO THAT'S
AFFECTED, I THINK, DECISIONS
WORLDWIDE.
OKAY, SO NEXT SLIDE THEN.
REALLY THE PROPOSED WORKING
GROUP THAT WE'VE DEVELOPED ABOUT
FIVE MAJOR CONSIDERATIONS THAT
WE'D LIKE TO DISCUSS IN THE
WORKING GROUP.
ONE IS TO EVALUATE THE EVIDENCE
OF THIS PERCEIVED SHORTAGE IN
PH.D.s THAT ARE SEEKING U.S.
POSTDOCS.
SO I THINK THE PERCEPTION IS
INCREASING, AND WE DEFINITELY
WANT TO -- YOU KNOW, ONE OF THE
MAJOR QUESTIONS OR WHAT ARE THE
DATA TO SUPPORT THAT.
YOU SAW A LITTLE BIT OF THAT
FROM TARA'S LAST DATA SLIDE,
WHERE THERE'S A DECREASED NUMBER
OF GRADUATE STUDENTS CHOOSING TO
CONTINUE INTO POSTDOCS.
THE SECOND ONE IS TO ASSESS AND
CONSIDER FACTORS INFLUENCING THE
SCOPE AND PERSISTENCE OF THE
ISSUE, AND SO HERE ALL OF THESE
POINTS THAT WE WERE JUST
DISCUSSING, WORK/LIFE BALANCE,
CHANGES IN -- YOU KNOW, I WOULD
SAY THE EMERGENCE OF A LOT OF
OPPORTUNITY IN INDUSTRY AND
BIOTECH, WHICH AS TARA MENTIONED
IS A GREAT THING, BUT WE JUST
NEED TO EVALUATE THE IMPACT OF
THAT ON GRADUATE STUDIES AND THE
DISPARITY IN THE AMOUNT OF
COMPENSATION IN THOSE SPHERES,
SO HOW IS THAT AFFECTING
DECISIONS.
SO REVIEW AND COMPARE OTHER
APPROACHES TO POSTDOCTORAL
TRAINING, SO HERE WE WANT TO
EVALUATE WHAT OTHER COUNTRIES
MIGHT BE DOING AND, YOU KNOW,
CONSIDERATIONS SUCH AS THAT.
FOURTH, CONSIDER WAYS TO SUPPORT
POSTDOCS' QUALITY OF LIFE AND
WORK-LIFE BALANCE.
HERE WE'RE DISCUSSING WAYS -- WE
WANT TO THINK OUTSIDE OF THE BOX
AND CONSIDER WAYS TO ENHANCE
QUALITY OF LIFE AND WORK-LIFE
BALANCE, AND HOW WE MIGHT
APPROACH THAT.
WE'RE ALREADY THINKING OF
VARIOUS WAYS THAT MIGHT BE
POSSIBLE.
AND THEN FINALLY, TO ENGAGE KEY
INTERNAL AND EXTERNAL
STAKEHOLDERS, SO HERE WE -- I
THINK WE HAVE THIS ON THE NEXT
SLIDE SO I THINK WE CAN PLACE OY
GO TO THAT.
SO MYSELF AND TARA, WE'RE GOING
TO CO-CHAIR THIS PROPOSED
WORKING GROUP.
TARA HAS A GREAT TEAM WHO HAVE
ALREADY BEEN HELPING US
ENORMOUSLY, JOEL ISLAM AND LAURA
LONG, SO THANK THEM FOR THE HELP
THEY'VE ALREADY GIVEN US TO
DEVELOP THE FIRST PLOTS HERE.
AND OUR PROPOSED MEMBERSHIP
WOULD BE ACD MEMBERS.
NIH MEMBERS.
WE'D LIKE TO INVOLVE POSTDOCS
AND GRADUATE STUDENTS.
I THINK THIS IS ABSOLUTELY
CRUCIAL RIGHT NOW.
AND SO WHERE TO GET THEM AND HOW
TO GET THEM, WE'VE BEEN
DISCUSSING THAT.
EARLY CAREER INVESTIGATORS.
THEY'RE CERTAINLY -- WELL, THE
FEELING IS THAT A PREVIOUS
WORKING GROUP HAS HAD A BIG
IMPACT THERE, AND IT'S VERY -- I
THINK IT WILL BE VERY
INTERESTING TO INVOLVE EARLY
CAREER INVESTIGATORS TO DISCUSS
THIS ISSUE, AND OF COURSE THEIR
CAREERS ARE VERY MUCH DEPENDENT
ON BRINGING IN TRAINEES, SO
HAVING THEM INVOLVED WILL BE
REALLY IMPORTANT.
WE WANT TO INVOLVE ACADEMIC
ORGANIZATIONS THAT ARE -- ALL
SORTS OF ACADEMIC ORGANIZATIONS
INCLUDING VARIOUS UNIVERSITIES
AND OTHER RESEARCH INSTITUTIONS
THAT ARE NOT UNIVERSITIES,
THEY'RE PARTICULARLY DEPENDENT
ACTUALLY ON POSTDOCS, SO IT WILL
BE IMPORTANT TO INVOLVE OTHER
SORTS OF ORGANIZATIONS.
POSTDOC, I THINK POSTDOC WE LEFT
OUT A WORD, AND GRADUATE STUDENT
ASSOCIATIONS BECAUSE WE NEED
THEIR HELP IN THE DATA
COLLECTION AND UNDERSTANDING THE
IMPACT OF THESE ISSUES.
AND TARA SUGGESTED, AND I THINK
IT'S A GREAT IDEA, TO INVOLVE
ECONOMISTS TO SEE -- TO BRING IN
PEOPLE TO LOOK AT THE FINANCES
HERE AND START TO THINK ABOUT
WHAT CAN WE DO AND WHAT SORT OF
APPROACHES WE CAN USE TO ADDRESS
SOME OF THE FINANCIAL ISSUES
INVOLVED THAT I THINK ARE FRONT
AND CENTER, TO BE HONEST ABOUT
IT AND FRANK.
SO I GUESS NEXT SLIDE.
HERE IS OUR PLAN.
TODAY WE'RE INVITING WORKING
GROUP MEMBERS, BOTH WITHIN THE
ACD AND WE'RE DEVELOPING A
SPREADSHEET OF OTHER POSSIBLE
MEMBERS TO INVOLVE.
WE WANT TO DISCUSS THIS IN MUCH
GREATER DETAIL IN THE NEXT ACD
MEETING IN DECEMBER, AND
THEREAFTER, WE WILL START OUR
MEETINGS AND THE HEAVY LIFTING
AND ADDRESSING THESE ISSUES.
WE'LL DRAFT RECOMMENDATIONS IN
JUNE AND HAVE FINAL
RECOMMENDATIONS IN
DECEMBER 2023.
SO NEXT SLIDE, PLEASE.
SO NOW WE'D LIKE TO OPEN IT UP
FOR YOUR THOUGHTS, ANY QUESTIONS
THAT YOU HAVE, AND FIRE AWAY.
WE'D LOVE TO HAVE YOU.
>>THANKS, SHELLEY.
TO YOUR POINT EARLIER, ALREADY
GETTING EMAILS FROM FOLKS
VOLUNTEERING TO BE ON THE GROUP.
SO --
>>WONDERFUL.
>>KEEP THEM COMING AND IF YOU
HAVE OTHER SUGGESTIONS, EVEN IF
YOU YOURSELF DO NOT WANT TO BE
IN THE GROUP OR NOT VOLUNTEERING
TO BE ON THE GROUP, WE'RE OPEN
TO THAT.
>>YES.
>>JUDITH, I SEE YOUR HAND
RAISED.
>>SO I THINK THERE ARE SORT OF
TWO SIDES TO THIS COIN.
ONE IS THE CONCERN ABOUT THE
POSTDOCS, AND THE OTHER IS THE
CONCERN ABOUT THE INVESTIGATORS
WHO AREN'T GETTING POSTDOCS.
AND ONE GROUP THAT I DIDN'T HEAR
MENTIONED IN YOUR PRESENTATION
WAS SENIOR SCIENTISTS.
I WONDER IF YOUR WORKING GROUP
IS PLANNING TO CONSIDER HOW TO
FOSTER THAT TRACK IN A MORE
EFFECTIVE WAY.
>>I'LL TAKE THAT.
ABSOLUTELY.
I THINK THAT'S A REALLY
IMPORTANT CONSIDERATION, HOW
WE'RE GOING TO DEVELOP THIS
TRACK.
PROBABLY -- YOU KNOW, TRY TO
ENHANCE THAT WITHIN ACADEMIA AND
PROVIDE -- I HOPE WE CAN FIND
WAYS TO PROVIDE THEM MORE
AUTONOMY AND MORE RESOURCES TO
HELP THEM TO ATTRACT POSTDOCS.
I ALSO WANT TO SAY -- WE DIDN'T
REALLY DISCUSS IT, THIS WAS VERY
CURRCURSORY, WHAT WE PRESENTED,T
ONE CONSIDERATION IN ADDITION TO
THAT, JUDITH, THE BIG THIRD
CATEGORY IS LOST -- WORRYING
ABOUT LOST BRAIN POWER INTO
ACADEMIA, INTO THE FUTURE.
I'M VERY CONCERNED ABOUT THAT.
WHAT'S GOING TO HAPPEN GOING
FORWARD .
I THINK ACADEMIA PROVIDES A LOT
OF RAW MATERIAL FOR INDUSTRY AND
BIOTECH, AND I THINK WE DON'T
WANT TO LOSE THAT.
A LOT OF SEED IDEAS AND SEED
KNOWLEDGE COME FROM ACADEMIA.
SO THANK YOU.
>>THANK YOU, SHELLEY.
WE ARE AT TIME AND I WANT TO
MAKE SURE THAT WE GIVE
SUFFICIENT TIME FOR THE NEXT
PRESENTATION.
>>THERE'S A VERY IMPORTANT
COMMENT IN THE CHAT BOX.
PERHAPS YOU COULD ARTICULATE
THAT FOR THOSE WHO CAN'T SEE THE
CHAT BOX, BECAUSE THAT'S A VERY
IMPORTANT POINT.
PLEASE.
>>YEAH, THERE'S A LOT OF
COMPLEXITIES RIGHT NOW THAT
WE'VE ALL BEEN SEEING IN GETTING
VISAS FOR INTERNATIONAL STUDENTS
AND INTERNATIONAL POSTDOCS.
THIS IS GOING TO BE SOMETHING WE
WILL HAVE TO ADDRESS, I THINK AS
PART OF THE WORKING GROUP.
>>AND THANKS FOR THE
SUGGESTION, FOR INCLUDING
SOMEONE WHO CAN REPRESENT THAT
VIEWPOINT.
>>THERE ARE PEOPLE WHO KNOW THE
INS AND OUTS OF THE COMPLEXITY,
SO I THINK IT WOULD BE GOOD TO
HAVE THEM INCLUDED.
THANK YOU.
>>THAT'S A GREAT SUGGESTION.
>>THANK YOU.
>>OKAY.
I'LL LOOK FORWARD TO MORE
DISCUSSION IN DECEMBER.
THANK YOU, SHELLEY.
>>THANK YOU.
>>WE WILL SHIFT GEARS NOW TO
ANOTHER PROPOSED ACD WORKING
GROUP THAT WE'RE PUTTING
FORWARD, AND THAT IS GOING TO BE
FOCUSED ON NOVEL ALTERNATIVE
MODELS AND METHODS THAT WE'VE
ASKED LYRIC JORGENSON AND HOWARD
CHANG TO CO-CHAIR, AND I THINK
HOWARD IS UNAVAILABLE TODAY, SO
LYRIC, YOU ARE GOING TO BE
PRESENTING, CORRECT?
SO TAKE IT AWAY.
>>SORRY, I WAS TRAPPED ON MUTE.
AND HOWARD CERTAINLY SENDS HIS
REGRETS.
HE HAD AN UNAVOIDABLE COULD BE
FLICT BUT IS PCONFLICTBUT IS PLG
THIS GROUP ALONG WITH MYSELF BUT
WE WILL SEE HIM IN DECEMBER AND
HE IS GOING TO BE A VALUABLE
CONTRIBUTOR.
SO AS EVERYONE KNOWS, HERE AT
NIH, WE HAVE THE BASIC MISSION
OF FUNDING RESEARCH THAT RELIES
ON A COMBINATION OF METHODS,
METHODOLOGIES AND TECHNOLOGIES
THAT REALLY HELP US EXPLORE
QUESTIONS ABOUT HUMAN HEALTH AND
DISEASE.
THESE APPROACHES EMPLOY A BROAD
PORTFOLIO OF MAMMALIAN,
NON-MAMMALIAN AND OF COURSE
NON-ANIMAL MODELS AND METHODS.
ANIMAL RESEARCH, PARTICULARLY IN
MAMMALS, COMES THE CLOSEST TO
MODELING THE COMPLEXITY OF
BIOLOGY AND DISEASE CIRCUIT AND
SYSTEMS, HOWEVER, WE'RE
CERTAINLY FINDING THAT NEWER AND
CLEARLY MORE SOPHISTICATED
METHODOLOGIES AND TECHNOLOGIES
ARE REALLY TRANSFORMING THE
CONDUCT OF SCIENCE IN A VARIETY
OF AREAS.
SO THESE METHODS ARE BEING
DEVELOPED AND APPLIED IN A WIDE
ARRAY OF AREAS, INCLUDING
DISEASE MODELS SUCH AS CANCER,
DIABETES, CARDIOVASCULAR
DISEASE, ALZHEIMER'S DISEASE,
MENTAL ILLNESS, I INFECTIOUS
DISEASE AND MORE.
AMAZINGLY AS YOU CAN SEE FROM
ONE OF THE ARTICLES, EVEN BEING
USED ON THE INTERNATIONAL SPACE
STATION TO STUDY HUMAN IMMUNE
FUNCTION.
SO IT'S CLEAR THAT THESE
INNOVATIVE APPROACHES HOLD GREAT
PROMISE FOR THE FUTURE OF
BIOMEDICAL RESEARCH.
IN DIFFERENT CONTEXTS, SOME OF
THESE NEWER METHODOLOGIES
ESPECIALLY THOSE THAT
INCORPORATE THE 3Rs, REPLACE,
REDUCE AND REFINE, HAVE BEEN
REFERRED TO AS ALTERNATIVE
METHODS OR NEW APPROACH
METHODOLOGIES.
WE RECOGNIZE THESE APPROACHES
ARE ACTUALLY COMPLEMENTARY TO
THE TRADITIONAL MODELS THAT WE
EMPLOY ALREADY AND THEY REFLECT
AN ESSENTIAL TOOL FOR INCREASING
OUR CAPABILITIES TO STUDY
BIOLOGICAL SYSTEMS.
HOWEVER, WE'RE GOING TO CHOOSE
TO USE THIS TERM, NOVEL
ALTERNATIVE METHODS, TO REALLY
ENCOMPASS THIS CATEGORY OF
RESEARCH METHODS FOR THE
PURPOSES OF CONSISTENCY WITH OUR
PARTNERS WORKING IN THIS AREA.
SO IT SHOULDN'T BE SURPRISING TO
ANYONE THAT NIH HAS A REALLY
ROBUST INVESTMENT IN THESE TYPES
OF TOOLS AND TECHNOLOGIES WHICH
CAN BE BROADLY CATEGORIZED IN
THREE DIFFERENT AREAS.
FIRST, IN CHEMICO STRATEGIES,
THESE ARE REALLY EXPERIMENTS ON
BIOLOGICAL MOLECULES LIKE DNA
AND PROTEINS AND TEST TUBES.
THE SECOND CATEGORY IS IN VITRO
METHODS SUCH AS EXPLORING THE
NATURE OF CELLS AND TISSUES BY
CULTURING THEM IN STERILE
CHAMBERS.
AND THE THIRD CATEGORY ARE
INSILICO MODEL, WHICH THESE
TYPICALLY EMPLOY COMPUTATIONAL
MODELS THAT SIMULATE HOW
BIOLOGICAL SYSTEMS WORK AND
PREDICT OUTCOMES TO REFINE
HYPOTHESES.
SO IMPORTANTLY I'D LIKE TO
EMPHASIZE THAT NIH HAS BEEN
WORKING WITH THESE MODELS SINCE
ITS FOUNDATION AND CURRENTLY
THROUGH THE PRESENT DAY.
WE'VE ACTUALLY SEEN A DRAMATIC
INCREASE IN THE LAST 15 YEARS IN
OUR INVESTMENT IN THESE TYPES OF
APPROACHES, AND THEY'LL CONTINUE
TO TRANSFORM THE SCIENCE THAT WE
DO.
CAVEAT, THOUGH, OF COURSE IS
IT'S ESSENTIAL THAT USE OF ANY
GIVEN APPROACH IS PREDICATED ON
THE NEED.
THAT MEANS IN TERMS OF THE
SCIENTIFIC APPROPRIATENESS OF
THE MODEL AND ITS RELEVANCE TO
THE RESEARCH INQUIRY TO SUPPORT
RIGOROUS AND REPRODUCIBLE
STUDIES.
BUT IT'S CRITICAL THAT WE
ACKNOWLEDGE THAT SOME OF THESE
POTENTIAL -- THE POTENTIAL OF
SOME OF THESE METHODS HAVE BEEN
OVERSOLD, AND THE VALUE MAY BE
LIMITED IN TERMS OF THE SCOPE
AND INSIGHT THEY CAN PROVIDE
INTO THE ACTUAL COMPLEXITY OF
HUMAN BIOLOGY, BEHAVIOR AND
DISEASE.
ADDITIONALLY, MANY OF THE ISSUES
THAT WE'VE DISCUSSED IN THE PAST
REGARDING RIGOR AND
TRANSLATABILITY IN ANIMAL MODELS
MUST ALSO BE ADDRESSED IN THESE
NON-ANIMAL MODELS, SUCH AS
CONSIDERATIONS OF HUMAN
BIOLOGICAL RELEVANCE, STUDY
DESIGN, STATISTICAL ANALYSES,
DATA SHARING, AND REPORTING.
HOWEVER, THERE ARE ALSO
ADDITIONAL CONSIDERATIONS THAT
ARE UNIQUE FOR RIGOR AND
TRANSLATABILITY, AND ALTERNATE
METHODS WITH THE DEVELOPMENT OF
NEW TECHNOLOGIES CAN OUTPACE
SCIENTIFIC CONSENSUS ON
STANDARDS.
SO BY UNDERSTANDING THE
LIMITATIONS OF THESE METHODS AND
IN WHAT TYPE OF RESEARCH STUDIES
THEY'RE LIKELY TO SURFACE, NIH
CAN REALLY START TO APPROACH
ADDRESSING THESE LIMITATIONS
WHERE POSSIBLE AND FOCUS ON
STRATEGICALLY INVESTING RESEARCH
INTO METHODS AND MODELS THAT ARE
BEST ABLE TO ANSWER THE RESEARCH
QUESTION AT HAND.
SO WHAT WE REALLY WANTED TO
BRING TO YOU ALL TODAY IS WHAT
IS NEEDED, WHICH IS AN HONEST
ASSESSMENT OF THE SCIENTIFIC
OPPORTUNITY.
BOTH IN TERMS OF WHERE THESE
TECHNOLOGIES HOLD PROMISE AND
WHERE THEY ARE LIMITED IN
APPROACH.
IT'S OBVIOUSLY ALREADY A TOPIC
OF INTENSE INTEREST AMONGST THE
SCIENTIFIC COMMITTEE.
YOU ALL HEARD ABOUT THIS
PREVIOUSLY FROM THE ACD'S PRIOR
WORKING GROUP ON ENHANCING
RIGOR, TRANS PARINS SEE AND
TRANSLATABILITY IN ANIMAL
RESEARCH, WHICH WAS VERY -- A
BEAUTIFUL SET OF RECOMMENDATIONS
LED BY LARRY TABAK AND BARBARA
WALD ON THE CALL TODAY.
WE ALSO HAD A NATIONAL ACADEMY
STUDY EXAMINING OPPORTUNITIES
FOR ALTERNATIVE METHODS TO
COMPLEMENT OR REDUCE RELIANCE ON
NIH-SUPPORTED RESEARCH OF
NON-HUMAN PRIMATES, AND ALSO
COMPLEMENTARY INITIATIVES ACROSS
THE U.S. GOVERNMENT SUCH AS THE
FDA, THE EPA, AND VETERANS
ASSOCIATION -- ADMINISTRATION.
SO WITH THIS INFORMATION AT HAND
AND WORKING COLLECTIVELY ACROSS
THE SCIENTIFIC COMMUNITY, WE CAN
BEGIN TO STRATEGICALLY
PRIORITIZE AREAS OF RESEARCH IN
WHICH ALTERNATIVES HOLD VALUE,
EITHER TO CATALYZE NEW SCIENCE,
IMPORTANTLY, AREAS IN WHICH
INCREASED FOCUS MIGHT ACTUALLY
CATALYZE THE NEW TECHNOLOGIES
THEMSELVES.
SO I OFTEN REFER TO CRISPR AS A
REALLY BEAUTIFUL EXAMPLE HERE.
WE HAD GENE EDITING CAPABILITIES
FOR QUITE SOME TIME IN THE
RECOMBINANT DNA WORLD WITH
NUCLEASES AND MEGA NUCLEASES.
THEY WERE DRAMATICALLY
REVOLUTIONIZED VIA THE INVENTION
OF CRISPR, WHICH HAS REALLY
DEMOCRATIZED THE WAY WE'RE ABLE
TO DO THE SCIENCE, CLEARLY THE
INVESTMENT IN TECHNOLOGY CROW
ATED NEW AVENCREATEDNEW AVENUESC
COMMUNITY.
SO THAT BRINGS US TO THE NEW
CHARGE TO THE ACD WHICH IS
REALLY THINKING ABOUT
ARTICULATING THE HIGH PRIORITY
AREAS FOR NIH INVESTMENT IN THE
USE AND DEVELOPMENT OF NOVEL
ALTERNATIVE METHODS TO, ONE,
ADVANCE PROGRESS INTO
UNDERSTANDING SPECIFIC
BIOLOGICAL PROCESSES OR STATES,
AND TWO, AUGMENT THE TOOLS AND
CAPABILITIES FOR BIOMEDICAL
RESEARCH TO COMPLEMENT AND/OR
POTENTIALLY REPLACE TRADITIONAL
MODELS.
WE'RE STILL FLESHING OUT THE
FINAL CHARGE AND WELCOME THE
ACD'S INPUT HERE TODAY.
AS MENTIONED BY TARA EARLIER,
THIS WILL BE CO-CHAIRED BY
HOWARD CHANG AND MYSELF.
WE ARE LOOKING FOR VOLUNTEERS
FROM THE ACD AND WORKING ACROSS
THE COMMUNITY TO GET EXPERTISE
IN THOSE WORKING WITH
ALTERNATIVE MODELS, THOSE WHO
HAVE EXPERTISE IN CREATING
BENCHMARK FOR ALTERNATIVE MODELS
AND THINKING ABOUT
TRANSLATABILITY ACROSS THESE
VARIOUS SECTORS.
ALSO INTERESTED IN EXPERTISE
FROM INDUSTRY AS WELL AS THOSE
WORKING TO TRANSLATE INTO ACTUAL
PRODUCTS FOR PATIENTS.
SO THE PROCESS IS ONGOING.
STAY TUNED, WE WILL GIVE YOU A
FULL UPDATE IN DECEMBER, AND OUR
PLANS FOR MOVING FORWARD, AGAIN,
ARE THE ROSTER BEING POPULATED
AND REPORT OUT IN DECEMBER.
WE WILL DISCUSS THE WORK PLAN
WITH THE ACD, AND THEN PLAN FOR
A VERY BUSY SPRING, WORKING ON
LOOKING THROUGH THE LANDSCAPE
ASSESSMENT IN THE AREAS OF
OPPORTUNITY.
THE GOAL IS TO PRESENT
PRELIMINARY FINDINGS TO THE ACD
IN JUNE OF NEXT YEAR, AND THEN
REALLY ENGAGE IN SOME FOCUSED
STAKEHOLDER ENGAGEMENT TO
UNDERSTAND AND GET FEEDBACK ON
ANY PRELIMINARY RECOMMENDATIONS
TO ISSUE A FINAL REPORT IN
DECEMBER.
SO I TRIED TO CATCH US UP ON
TIME, TARA, BUT I HOPEFULLY LEFT
A FEW MINUTES FOR QUESTIONS.
>>THAT WAS GREAT.
THANKS, LYRIC.
WE HAVE FIVE MINUTES.
I ALREADY SEE A HAND UP, SO
ATUL, YOU WANT TO START OFF THE
Q & A?
>>I THINK THIS WAS GREAT.
I THINK THE CULTURE OF
COMPLEMENTARY AND ALTERNATIVE
MAYBE CAN CONFUSE PEOPLE BECAUSE
THERE ARE OTHER THINGS NAMED
WITH SOME OF THOSE PHRASES, SOME
OF THE OTHER -- CULTURE.
JUST TO ADD INTO INSILICO, SINCE
NIH IS GOING TO BE REQUIRING SO
MANY PEOPLE TO SHARE DATA
STARTING IN LATE JANUARY, HOW
ABOUT SOME DATA-DRIVEN ONES AS
WELL, COMPUTER DATA-DRIVEN.
I KNOW INSILL COAL IS A --
CATEGORY BUT MAYBE REAL WORLD,
EVIDENCE WORLD FOR CLINICAL.
A LOT OF THESE SEEM TO BE
MOLECULAR, YOU MIGHT WANT TO
THROW THEM A BONE OR TWO HERE
TOO.
THANKS.
>>THANKS.
I SEE BARBARA'S HAND UP AND THEN
DINAH.
BARBARA?
>>HI.
TWO THINGS.
FIRST OF ALL, I'M ENORMOUSLY
IMPRESSED A BIT AND A PART OF
THIS DID COME OUT OF THE ANIMAL
RIGOR, AND I'M HAPPY TO SEE THAT
GOING FORWARD.
BUT WITH RESPEKD RESPECT TO THEH
OF THINGS BEING CONSIDERED HERE,
THE BREADTH IS ENORMOUS, AND I
WONDER WHETHER THERE'S ANY
DEBATE AS YOU'RE SETTING THIS UP
ABOUT WHETHER IT'S GOING TO STAY
AS BROAD AS PRESENTED, WHICH
SEEMED ALMOST TO BE SORT OF
EVERYTHING EXCEPT CLINICAL
TRIALS.
IT SEEMED TO BE VERY, VERY
LARGE.
AND I'M WONDERING IF THAT'S
GOING TO GET IN THE WAY OF
ACHIEVING SPECIFIC --
IDENTIFYING AND ACHIEVING
SPECIFIC GOALS.
MY SECOND QUESTION IS A MUCH
QUICKER ONE.
IN THE REPORT OUT TO NIH AND
ABOUT HOW NIH DEPLOYS ITS
RESOURCES, DOES THAT INCLUDE
ARPA-H?
>>LARRY, DID YOU WANT TO --
>>I'LL TACKLE THE SECOND
QUESTION AND DEFER QUESTIONS
ABOUT ARPA-H TO TE TARA, BUT IN
TERMS OF THE BREADTH AND SCOPE,
YOU HI HIT THE NAIL ON THE HEADT
SOME LEVEL.
WE HAD DONE SOME PRELIMINARY
INTERNAL ANALYSES ABOUT THE
SCOPE OF OUR INVESTMENT AND YOU
SAW THOSE BROAD BUCKETS OF
CATEGORIES WHICH WE'RE ONLY
MISSING CLINICAL TRIALS AND
INVERTEBRATES, RIGHT?
SO HOW CAN WE MAKE A REALLY
CLEAR SCOPE, EITHER CAPITALIZING
ON EMERGING TECHNOLOGY OR
SOMETHING THAT REALLY CAPTURES
THE PROMISE AND THE ADVANCE THAT
WE ARE NOT BOILING THE OCEAN,
BUT REALLY HAVING A STRATEGIC
ANALYSIS THAT INFORMS FUTURE
RESEARCH DIRECTION.
SO I THINK THIS IS SOMETHING WE
WILL TAKE BACK TO OUR TEAM TO
SEE IF WE CAN HONE THIS CHARGE
AND MAKE IT REALLY CONCRETE WHEN
WE MEET IN DECEMBER.
>>IT WOULD BE A GIFT TO THE
COMMITTEE IF IT'S HONED A LITTLE
BIT, LEST THEY SPEND THEIR FIRST
SIX MONTHS DOING SAME.
>>AND WITH RESPECT TO YOUR
SECOND QUESTION, BARBARA, WITH
ARPA-H, AS RENE, THE DIRECTOR OF
ARPA-H LIKES TO SAY, STARTING
EVERY CONVERSATION IS, SHE'S ON
WEEK FOUR, SO SHE NEEDS A
MINUTE.
SO SHE'S STILL FORMING SORT OF
WHAT THE SCOPE OF ARPA-H IS
GOING TO BE, AND SO WHILE ARPA-H
IS A PART OF NIH, WE'RE GOING TO
BE FIGURING SOME OF THIS STUFF
OUT IN REALTIME.
>>FAIR ENOUGH.
I MEAN, IT DOES SEEM LIKE
THERE'S ROOM FOR SOME ACTUALLY
REALLY CONSTRUCTIVE, I DON'T
KNOW WHETHER IT'S OVERLAP OR
INTERDIGITATION OR WHATEVER, BUT
SOME OF THESE AREAS LOOK LIKE AT
LEAST SOME CONCEPTS OF WHAT
ARPA-H MIGHT INCLUDE IN THE
PORTFOLIOS, THEY SEEM TO RELATE.
>>DINA?
>>YOU MENTIONED IN VITRO AND
INSILICA IN ANIMAL MODELS, BUT
IF YOU LOOK AT WHERE -- LIKE WE
HAVE SO MANY ADVANCES IN THE
PAST AND IF YOU LOOK AT THE
SITUATION NOW, MANY OF THE
DISEASES ARE LEFT WHERE WE HAVE
HUGE CHALLENGES, LIKE IN
NEUROSCIENCE, FOR EXAMPLE, OR
IMMUNOLOGY AS WELL, WHERE NOT
JUST THE ANIMAL MODELS DON'T
WORK WELL, BUT ALSO EVEN THE
SINGLE CELL MODEL, EVEN IF YOU
BRING IT FROM HUMAN, IT DOESN'T
WORK AS WELL BECAUSE LIKE
IMMUNOLOGY, FOR EXAMPLE, IS A
HUGE SYSTEM AND HUGE NETWORK
THTHAT INTERACT TOGETHER, SO I
WONDER IF YOU HAVE MORE ACTUALLY
GETTING CLOSER TO THE HUMAN
MAYBE LIKE WITH DATA-DRIVEN
APPROACHES, BEING ABLE TO
ADDRESS LIMITATION OF WHERE WE
ARE HAVING CHALLENGES NOW WITH
IMMUNOLOGY OR WITH NEUROSCIENCE.
>>THANK YOU FOR THAT QUESTION.
AND IT'S WORTH EXPLORING THAT
MORE IN THE CHARGE.
SOME OF THE ASPECTS WE'RE
TALKING ABOUT, THE TECHNOLOGIES
THEMSELVES, THERE'S STRENGTHS
AND LIMITATIONS BUT YOU COULD
FLIP THE QUESTION ON ITS HEAD OF
WHAT WE ARE TRYING TO MODEL AND
HOW T TO INCENTIVIZE NEWER AFTER
PROACHS APPROACHES, SO SOMETHINN
EXPLORE MORE ABOUT THE REVALUE L
VALUE FOR THE COMMUNITY.
>>I THINK THE NIH HAS
INDIRECTLY ENFORCED THIS MODEL
BECAUSE OF THE FUNDING.
TRADITIONALLY WE THOUGHT OF
EXACTLY THIS PIPELINE, AND THERE
ARE MORE CHALLENGES -- OF COURSE
YOU WANT TO GET TO HUMANS WHILE
YOU ARE SAFE DOING IT AND IN A
SAFE, REASONABLE WAY THAT DOES
NOT BURDEN PATIENTS AND
INDIVIDUALS.
BUT I MEAN, UNLESS WE ADDRESS
THIS HURDLE, WE ARE GOING TO
CONTINUE BUILDING IN THIS DOMAIN
WHERE WE HAVE A LOT OF EXPERTISE
BUT WE ARE UNABLE TO SOLVE THIS
BIG JUMP FOR THESE MAJOR FIELD
THAT WE DON'T HAVE MUCH IN YET.
>>THANKS.
LARRY, I SEE WE'RE AT 6:01, SO
I'LL TURN IT BACK TO YOU AND,
AGAIN, WE CAN HAVE MUCH FURTHER
DISCUSSION ON THESE TOPICS AND
ADDITIONAL INFORMATION WILL BE
SHARED IN DECEMBER SO LARRY?
>>FIRST I WANT TO THANK ALL THE
MEMBERS OF THE COMMITTEE FOR
TAKING TIME OUT THIS EVENING TO
JOIN US.
I HOPE YOUR INTERESTS HAVE BEEN
PIQUED, AND THAT THE MEETING IN
DECEMBER IS NOT GOING TO BE
BORING.
WE HAVE THREE REALLY IMPORTANT
AND INTERESTING TOPICS THAT
WE'RE GOING TO WANT YOU TO
WRESTLE WITH AND OF COURSE THERE
ARE OTHER TOPICS AS WELL BUT WE
WANTED TO INTRODUCE THESE TO YOU
AND THE COMMUNITY AT LARGE
BECAUSE THIS IS A PUBLIC
MEETING, OF COURSE, TO REALLY
GET PEOPLE TO BEGIN TO THINK
ABOUT THESE THINGS.
BECAUSE THEY ARE COMPLICATED BUT
THEY ARE VERY, VERY IMPORTANT TO
THE WAY THE AGENCY SUPPORTS
SCIENCE.
SO WITH THAT, WE CERTAINLY LOOK
FORWARD TO SEEING AS MANY OF YOU
AS POSSIBLE IN PERSON.
IF NOT, IF THAT'S NOT POSSIBLE,
CERTAINLY VIA VIDEO, BECAUSE IT
WILL BE -- BOTH OPTIONS WILL BE
AVAILABLE, AND UNTIL THEN, IF
YOU HAVE IDEAS FOR THE WORKING
GROUPS OR IF YOU HAVE IDEAS FOR
THE FIRST TOPIC, PLEASE DON'T BE
BASHFUL.
I KNOW THIS GROUP IS NOT
BASHFUL, BUT PLEASE DON'T BE
BASHFUL AND SEND IN YOUR
SUGGESTIONS, ET CETERA, TO TARA.
AND AGAIN, THANK YOU AND WE LOOK
FORWARD TO SEEING YOU IN
DECEMBER.
HAVE A GOOD EVENING, EVERYBODY.