>> WELCOME TO THE 223rd NINDS
COUNCIL MEETING.
SO I JUST WANTED TO SAY A COUPLE
THINGS.
WE UNFORTUNATELY HAVE TO SAY
GOOD-BYE TO SOME FOLKS BUT MAYBE
NOT.
WE HAVE A COUPLE COUNCIL MEMBERS
WHOSE TERMS WILL END AND HOPE
HHS WILL APPROVE THE NEW SLATE.
HOPE IN THAT INSTANCE IT'S
USUALLY FUTILE AND THE FOLKS
WHOSE TERMS ARE UP ARE EKEMINI
REALLY AND TIM RYAN AND DAVID
BRODY.
YOU'VE ALL BEEN REALLY FANTASTIC
CONTRIBUTORS TO NINDS.
WE HAVE YOU ON SPEED DIAL AND
WILL BE SURE TO CALL YOU AGAIN
FOR THINGS WE APPRECIATE ALL THE
TIME YOU'VE SPENT ON COUNCIL.
THESE ARE THE MOST IMPORTANT
MEETINGS.
YOU ARE THE FEDERALLY APPROVED
ADVISORS TO THE INSTITUTE AND WE
HAVE REALLY VALUED YOUR ADVICE
IN SERVICE.
THANK YOU VERY MUCH.
NOW I'LL TURN IT OVER TO DAVE.
>> THANKS, WALTER.
I WANT TO ECHO THE THANKS AND
YOU JUST WHEN YOU THOUGHT YOU
GOT OUT WE PULL YOU BACK IN.
I ALSO WANT TO ACKNOWLEDGE OUR
NEW ALMOST COUNCIL MEMBERS, DAN
FLORIAN, BOB, FRANCES AND KATE.
AS WALTER MENTIONED WE ARE GOING
DOWN THE APPROVALS PATHWAY AS
FAST WE CAN.
UNFORTUNATELY, DAN WILL NOT BE
JOINING US TODAY.
SO I WANT TO REMIND EVERYONE
WE'RE VIDEOCAST LIVE.
SO THE WORLD CAN SEE US.
THIS IS NOW A HYBRID MEETING SO
THERE ARE PEOPLE BOTH IN THE
ROOM WITH US AND ON THE ZOOM.
SO WE WANT TO HAVE OUR CAMERAS
ON AT BOTH TIMES.
FOR THE COUNCIL MEMBERS, I WANT
TO REMIND EVERYONE TO SAY LOGGED
INTO THE ECB AS WE DID LAST
TIME.
I THINK WE PILOTED IT AND IT
SEEMED TO WORK WELL.
WE'LL BE DOING ALL THE VOTING
VIA THE ECB OPPOSED TO THE ZOOM
E
ERA.
>> FOR THOSE IN THE EVB THERE
WILL BE A LITTLE BIT OF A LAG SO
REFRESH THE SCREEN.
I'LL GIVE YOU A HEADS UP WHEN
IT'S TIME TO REFRESH AND WE'LL
PROBABLY BE VOTING SOON.
SO REFRESH YOUR ECB SCREEN AND
MAKE SURE EVERYONE IS LOGGED IN
AND YOU'LL GO TO THE VOTING TAB
AND THAT'S WHERE WHEN IT GETS TO
THAT I'LL WALK YOU THROUGH WHAT
TO DO.
>> AND TO REMIND FOLKS WHEN WE
GET TO VOTING WHERE THERE ARE
CONFLICTS YOU WILL NOT BE ABLE
TO VOTE IN CONFLICT SO THAT WILL
TAKE CARE OF ITSELF.
VERY GOOD.
OUR FIRST ORDER OF BUSINESS IS
CONSIDERATION OF THE FEBRUARY 14
AND 15, 2024 COUNCIL MEETING
MINUTES.
EVERYONE, GO TO THE VOTING TAB
IT SHOULD BE THE FIRST ONE THAT
POPS UP AND YOU'RE GOING TO
CLICK ON WINTER 2024 MEETING
MINUTES.
THEN YOU'LL DO SAVE AND SUBMIT
AFTER YOU CHECK YES OR NO.
NOBODY'S IN CONFLICT WITH THE
MEETING MINUTES.
WE DON'T NEED TO BANISH ANYBODY.
WHILE WE'RE WAITING FOR THAT,
I'M GOING TO MOVE ALONG.
SO WE DO ALSO IN THE ECRB FUTURE
COUNCIL DATES SO BLOCK THEM OFF
TO MAKE SURE YOU CAN MAKE IT.
IT'S AN FYI AND ACTION ITEM TO
BE AVAILABLE TO JOIN US.
OKAY.
ARE WE VOTED?
>> LET'S MOVE ON.
>> THE NEXT ITEM IS TO GIVE A
READ OUT OF OUR EXPEDITED REVIEW
PROCESS.
THIS IS WHERE WE HAVE A BUNDLE
OF GRANTS THAT ARE BASICALLY IN
THE PAY LINE, NO ADMINISTRATIVE
ISSUE READY TO GO AND WHAT WE DO
IS WE ASK THREE COUNCIL MEMBERS
TO DO A VET OF THOSE TO MAKE
SURE THEY LOOK GOOD.
AND THIS TIME WE HAD TIM, AMY
AND HE LOUISE DO THAT AND WANT
TO THANK YOU FOR THAT AND IT
HELPS GET GRANTS OUT THE DOOR AS
FAST AS POSSIBLE AND THE WORK OF
OUR GRANTS MANAGEMENT BRANCH LED
BY SHELLY WILLBURN AND THE
PROGRAM STAFF WHO LOOK AT THESE
AND GET THEM READY TO GO AND
IT'S AN EFFICIENT PROCESS AND
GOOD TO GET THINGS OUT AS FAST
AS WE CAN.
OKAY.
VERY GOOD.
THANKS TO ALL FOR THAT.
THEN THE FINAL THING I HAVE TO
KICK US OFF IS OUR EXTRAMURAL
ANNOUNCEMENTS OF OUR STAFF AND I
BELIEVE WE HAVE COMINGS, GOINGS,
PROMOTIONS, ETCETERA AND THE
BIOS OF THESE INDIVIDUALS IN THE
COUNCIL BOOK BUT WE'LL PUT UP A
SLIDE.
THERE WE GO.
WE WANT TO SHARE WITH EVERYONE
WHERE WE STAND WITH THE SLIDE.
AGAIN, TO THE BIOS ARE IN THE
COUNCIL BOOKS AND TAKE A LOOK.
AND WITH THAT I THINK, WALTER,
WE'LL PASS IT BACK TO YOU.
>> ALL RIGHT.
SO THANK YOU.
MAY I HAVE THE SLIDES?
SO THIS IS MY CHANCE TO TALK TO
YOU A LITTLE BIT ABOUT WHAT'S
GONE ON AT NINDS SINCE LAST WE
MET.
AND I THINK THE BIGGEST NEW
THING IS WE ACTUALLY GOT A
BUDGET SINCE LAST WE MET.
SO, WE'RE GOING TO GO THROUGH
WHAT THAT ENTAIL AND THE
DETAILS, UNFORTUNATELY.
ANY WAY, IT'S A PLEASURE TO TALK
TO YOU TODAY.
OUR INSTITUTE I THINK IS
INCREDIBLY HEALTHY, GREAT STAFF
AND GREAT PROJECTS, FUNDING
GREAT SCIENCE AND JUST HATS OFF
TO ALL THE PEOPLE WHO WORK HERE
SO DEDICATED AND HARD WORKING.
TO THE UPDATES OF LEADERSHIP AT
NIH THE BIGGEST NEWS IS THAT
DR. JOSH GORDON IS STEPPING DOWN
AS THE NIMH DIRECTOR RETURNING
TO COLUMBIA TO BE THE SHARE OF
DEPARTMENT OF PSYCHIATRY AND
DR. AVENEVOLI HAS BEEN DEPUTY
DIRECTOR SINCE 2017.
WE'LL MISS JOSH.
HE WAS A STRONG NEUROSCIENTIST,
STRONG IN TERMS OF CLINICAL
PSYCHOLOGY.
VERY PRODUCTIVE MEMBER OF THE
I.C. DIRECTORS GROUP.
SO, HE'LL BE SORELY MISSED.
IF YOU KNOW OF PEOPLE YOU THINK
WOULD BE GOOD FOR THE JOB LET ME
KNOW BECAUSE WE NEED A GOOD
PERSON TO COME IN.
DR. KATHLEEN NEUZIL WAS SELECTED
AS THE DIRECTOR OF THE FOGARTY
DIRECTOR AND INTERNATIONAL
RESEARCH.
THE FOGARTY CENTER HAS BEEN
IMPORTANT TO NINDS FOR ALL THE
WORK WE DO IN GLOBAL HEALTH.
WE GENERALLY RUN THINGS THROUGH
THE FOGARTY.
THEY HAVE CONTACTS AND A LONG
HISTORY WORKING IN UNDER
DEVELOPED COUNTRIES WHICH HAS
REALLY HELPED US IN TERMS OF
HAVING PROGRAMS THAT ARE
EXECUTABLE IN THESE VERY
DIFFICULT ENVIRONMENTS OFTEN
TIMES.
SO LOOKING FORWARD TO WORKING
WITH KATHLEEN AS WE GO FORWARD.
AND REALLY A PLEASURE TO SAY
DR. MICHELLE JONES LONDON HERE
AT THE TABLE BECAUSE SHE'S BEEN
SELECTED AS THE FIRST ASSOCIATE
DIRECTOR FOR NINDS PROGRAMS TO
ENHANCE NEUROSCIENCE WORKFORCE.
SO THIS IS A LEADERSHIP ROLE IN
WHICH SHE WILL BE ADVANCING THE
NIH MISSION THROUGH DEVELOPING
INCLUSIVE AND EQUITABLE
NEUROSCIENCE TRAINING AND
PROGRAMS THROUGHOUT THE COUNTRY
AND WORKING IN OUR INTRAMURAL
RESEARCH PROGRAM.
SHE'LL ALSO BE WORKING HARD WITH
A NUMBER OF FOLKS IN THE OFFICE
OF THE DIRECTOR TO PROMOTE A
POSITIVE AND EQUITABLE WORKFORCE
ENVIRONMENT AT NINDS AND DEVELOP
DATA-DRIVEN STRATEGIES TO
STRENGTHEN THE NEUROSCIENCE
RESEARCH PORTFOLIO BY BRINGING
DIVERSE PERSPECTIVES TO THE
SCIENTIFIC ENDEAVOR.
SO WE'RE PLEASED.
MICHELLE HAS BEEN A FANTASTIC
CONTRIBUTOR TO THE NIH MISSION
FOR MANY YEARS.
WE LOOK FORWARD TO HER
CONTRIBUTIONS AS ONE OF THE TOP
FIVE LEADERS HERE AT NINDS.
TOP FIVE IS A TERM THEY USE AT
NINDS.
THE FIVE DOESN'T ACTUALLY MEAN
TEMPERATURE.
SOMETIMES THERE'S FOUR.
SOMETIMES THERE'S SIX BUT YOU
GET THE IDEA.
PLEASURE TO HAVE YOU AT THE
TABLE.
OKAY.
NOW WE'LL TALK ABOUT THE BUDGET
AND AS YOU KNOW I ALWAYS TRY AND
BE VERY TRANSPARENT ABOUT HOW WE
SPEND THE TAXPAYERS' FUNDS FOR
NEUROSCIENCE RESEARCH.
AND WHAT YOU SEE HERE IS THE
TOTAL NINDS APPROPRIATION SINCE
2020 THROUGH WHAT WAS ENACTED IN
2024 AND WE ALSO SHOW YOU THE
PRESIDENT'S BUDGET FOR 2025,
CAVEAT THERE BEING THE PRESIDENT
DOESN'T SET THE BUDGET, THE
CONGRESS SETS THE BUDGET SO IT'S
NOT SOMETHING WE CAN COUNT ON
BUT CLEARLY IS A SIGN THAT
THERE'S AT LEAST AT THAT LEVEL
THERE'S ENTHUSIASM FOR THE NIH
INFRASTRUCTURE AND GRANTS AND
SCIENCE.
SO AS YOU CAN SEE, IN RED IN
2024 NINDS HAD THE BUDGET
REDUCED BY 4.4%.
THIS IS IN CONTRAST TO WHAT YOU
SAW SINCE 2016 WHICH WERE ANNUAL
INCREASES IN THE BUDGET.
SO THAT IS WHAT WE'RE GOING TO
TALK ABOUT AND WHAT IT MEANS AND
WHAT WE HAD TO DO TO TRY TO DO
OUR BEST WITH THE LIMITED FUNDS.
ROOM.
SO ON THIS SLIDE WE'RE GOING TO
TALK ABOUT WHAT WE CALL THE BASE
BUDGET OF NINDS.
AND THIS TERM WE USE FOR THE
FUNDS THAT COME TO NINDS THAT
CAN BE USED FOR ANY PURPOSE.
SO THESE ARE THE FUNDS THAT
SUPPORT DISCOVERY, RO1 GRANTS,
TRANSLATIONAL GRANTS, THE
CLINICAL TRIALS THAT ARE NOT
TARGETING ANY PARTICULAR DISEASE
OR ANY PARTICULAR SCIENCE
PROGRAM.
AND WHAT YOU CAN SEE IS THAT WE
ARE FLAT IN '24 COMPARED TO '23.
AND IN THE PRESIDENT'S BUDGET WE
ARE ALSO PRETTY MUCH FLAT.
SO THE POINTS HERE IS THAT WE
ARE DEALING WITH A BUDGET THAT
DOES NOT ACCOUNT FOR ANY
INFLATIONARY INCREASES IN THE
COST OF SCIENCE AND WE'LL SEE
WHAT THE IMPACT OF THAT IS BUT
THAT IS THE SITUATION.
IN ADDITION, THE BUDGET DEAL
THAT WAS MADE IN CONGRESS WHICH
IS REFLECTED HERE IN THE
PRESIDENT'S BUDGET IS THE '25
BUDGET WILL NOT BE SUBSTANTIALLY
BETTER THAN THE '24 BUDGET.
THE NUMBERS WE HAVE WE HAVE TO
WORK WITH THEM '24 AND '25 THE
CHANCE FOR A CHANGE WOULD COME
LIKELY IN 2026 DEPENDING ON ALL
SORTS OF ISSUES.
THE FLAT BUDGET IN '24 IS WHAT
NIH GOT OVER ALL.
THEN THE QUESTION -- AND I ALSO
WANTED TO MENTION AND WE'LL SEE
ON THE NEXT SLIDE THAT WE SEE
NOT JUST THE BASE THE POT GROW
WE JUST DISCUSSED BUT WE TALK
ABOUT THE OTHER FUNDS THAT COME
TO NINDS THAT ARE WHAT WE MIGHT
CALL TARGETED FUNDS FOR
PARTICULAR PROJECTS.
AND THOSE ARE SUBSTANTIAL.
IT WAS ALMOST A THIRD OF OUR
BUDGET IN 2023.
SO THE FIRST ONE TO NOTE IS THE
BRAIN INITIATIVE.
AND JOHN NGAI WILL TALK ABOUT
THE BRAIN INITIATIVE LATER TODAY
IN THE OPEN SESSION.
BUT THE BRAIN INITIATIVE FUNDS
IN 2020, 2021, 2022, 2023 CAME
IN TWO BUCKETS.
BASE TO THE INSTITUTE IN THE
APPROPRIATION AND THE SECOND
WITH FUNDS THAT CAME FROM THE
21st CURES ACT.
THOSE FUNDS WERE SET TO EXPIRE,
ARE SET TO EXPIRE IN 2026.
THAT WAS THE LAST YEAR WE GET
THOSE CURES FUNDS BUT THE REALLY
GOOD NEWS WAS THAT CONGRESS HAD
APPROPRIATED BASE FUNDS FOR
NINDS THROUGH THE POINT OF
$182,890,000 AND WE WORKED UNDER
THE ASSUMPTION WE'D BE ABLE TO
USE THE BASE FUNDS AND MADE A
COMMITMENT WITH THE OTHER
NEUROSCIENCE INSTITUTES WE'D
CONTINUE THE BRAIN INITIATIVE
WORK OUT PAST 2026 USING THE
BASE FUNDS.
THE PROBLEM CAME IN 2023 WHEN
THERE WAS A BIG INCREASE IN THE
CURES ACT FUNDS.
THEY WENT FROM AS YOU CAN SEE
FROM $76 MILLION TO $225 MILLION
IN 2023.
AND THE DECISIONS WERE MADE THAT
WE WOULD ACCEPT THE CURES MONEY
BUT THEY WOULD REDUCE THE BASE
MONEY TO THE INSTITUTES IN 2023
BUT THE EXPECTATION THE BASE
FUNDS WOULD THEN BE MANY
RESTORED IN 2024.
THAT WAS THE PLAN GOING INTO
2023.
WE WEREN'T HAPPY WITH IT BUT WE
DIDN'T HAVE TOO MUCH CHOICE AND
THEN WHAT HAPPENED IN 2024 IS
THAT THOSE BASE FUNDS WERE NOT
RESTORED.
SO THE BASE FUNDS FOR BRAIN
REFLECT THE DECREASE WE SAW IN
2023 AND IN 2024 THE AMOUNT OF
CURES MONEY DROPPED FROM $225
MILLION TO $86 MILLION AND
THAT'S WHAT ACCOUNTS FOR THE
4.4% DROP IN BUDGET.
NIMH HAD A SIMILAR ISSUE EXCEPT
WE SEE THE $100 MILLION INCREASE
TO THE BASE BUDGET SO THEIR DROP
IN BRAIN -- THEY ACTUALLY WILL
BE ABLE TO PUT SOME MONEY INTO
BRAIN FROM THEIR BASE BUDGET.
SO THAT'S WHERE THE DECREASE IN
THE BUDGET WAS FELT PRIMARILY IN
THE BRAIN INITIATIVE.
THE BASE BUDGET IS FLAT.
WE'LL TALK A LITTLE BIT MORE
ABOUT THE FLAT BASE BUDGET AND
JOHN WILL TALK TO YOU A LITTLE
BIT -- WELL, A LOT ABOUT WHAT HE
AND HIS TEAM HAVE TO DO TO
RECONCILE THEIR MISSION WITH THE
DECREASE IN FUNDING THAT THEY
HAVE.
OF COURSE THE MOST IMPORTANT
THING FOR US IS LOOKING FORWARD
IS TO HAVE THAT BASE RESTORED SO
WE CAN CONTINUE WITH THE BRAIN
INITIATIVE AND THE AMAZING THING
TOOLS AND SCIENCE THAT HAVE COME
FROM IT THAT HAVE CHANGED AND
HAD AN AMAZING AND IN 2026 IS
WHEN WE MIGHT HAVE A CHANCE TO
TRY AND DO THAT AGAIN.
DOES ANYBODY HAVE ANY QUESTIONS
ABOUT THAT PART OF IT.
>>Reporter: AND IT'S A TOTAL OF
>> IT'S A TOTAL OF ABOUT $85
MILLION BUT WHEN ABRD WAS FIRST
APPROPRIATED BY CONGRESS MOST
WENT TO THE AGING INSTITUTE AND
WE'VE BEEN MANAGING 10% OF THOSE
FUNDS SO EACH YEAR WE MANAGE
ABOUT $360 MILLION OF AD/ADRD
FUNDS AND $85 MILLION IN THE
BASE AND THE REST FROM FUNDS
FROM NIA WE THEN MANAGE.
SO, YES.
USE YOUR MIC.
>> QUICK INTERIM QUESTION WHICH
IS THE FY25 PRESIDENT'S BUDGET
COLUMN SHOWS THE BRAIN BASE
GOING UP AND EVERYTHING ELSE NOT
SO MUCH.
IS IT OPTIMISTIC TO THINK THAT
MAY BE POSSIBLE?
MAYBE WE'LL HEAR FROM JOHN ABOUT
THAT.
>> MOST PEOPLE ARE NOT
OPTIMISTIC THAT'S GOING TO
HAPPEN BECAUSE THE BUDGET OVER
ALL HAS TO STAY FLAT SO IF IT
INCREASES TO US, IT WOULD HAVE
TO DECREASE ANOTHER INSTITUTE.
SO IT SEEMS UNLIKELY FROM WHAT
WE HEARD.
WE CAN ALWAYS GET LUCKY BUT
THAT'S WHAT WE HEARD SO FAR.
SO I THINK WE HAVE TO PREPARE
FOR 2026 TO TRY AND MOVE THE
SCIENCE AS BEST WE CAN UNTIL
2026.
JOHN WILL TELL YOU THAT HE HAS
HE AND THE REST HAVE BEEN
TALKING ABOUT THIS FOR A WHILE
SO THERE WAS A PLAN, WASN'T WHAT
WE LIKE, BUT THERE WAS A PLAN TO
EVEN THINGS OUT AND HE HAS THE
ABILITY WHICH WE DON'T HAVE
WHICH IS THE CURES MONEY DOES
NOT HAVE TO BE SPENT EVERY YEAR,
IF NOT SPENT IT HAS TO BE
RETURNED SO THEY'RE ABLE TO
CARRY OVER FUNDS TO SMOOTH OUT
THE UPS AND DOWNS OF THE CURES
FUNDING SO HE'LL TALK TO YOU
MORE ABOUT THAT.
THE OTHER FUNDS WERE FOR THE
UNDIAGNOSED NETWORK AND THE
UNDIAGNOSED DISEASE NETWORK DOES
HAVE A COMPONENT OF FUNDS THAT
COME FROM OTHER INSTITUTES
INTERESTED IN THE UNDIAGNOSED
DISEASE NETWORK SOME WHERE
AROUND $3.5 MILLION COMES FROM
OTHER INSTITUTES AND THE OFFICE
OF THE DIRECTOR TOLD US THEY'D
HELP US MAKE UP THE DIFFERENCE
BUT CAN ONLY HELP THIS YEAR NOT
NEXT YEAR.
THERE MAY BE ANOTHER $15 MILLION
OR SO DOWN NEXT YEAR IF THAT
APPROPRIATION ISN'T INCREASED
FOR THE UNDIAGNOSED DISEASE
NETWORK.
THEN WE HAVE $75 MILLION THAT
CAME TO US UNDER THE ACT FOR
ALS.
THAT COMES TO THE OFFICE OF THE
DIRECTOR AND THEN WE MANAGE THE
FUNDS.
THAT PROGRAM IS STIPULATED THAT
EXPANDED ACCESS GRANTS RECEIVE
THE TOP PRIORITY.
THESE ARE GRANTS THAT ALLOW
PEOPLE WHO HAVE ALS AND NOT
ELIGIBLE FOR CLINICAL TRIALS TO
RECEIVE INVESTIGATIONAL DRUGS
BEING TESTED IN THE PHASE III
TRIALS BY SMALL BUSINESS
COMPANY.
I THINK ONE'S COMING TO COUNCIL
TODAY AND AFTER WE WERE TOLD
THEY COULD BE USED FOR THE
PUBLIC PRIVATE PARTNERSHIP AND
THERE'S AMAZING STUFF WITH
PARTNERSHIP WITH INDUSTRY AND
NONPROFITS AND WE DEVELOPED A
CONSORTIUM OF ALS SITES ACROSS
THE COUNTRY TO COLLECT DATA FROM
PATIENTS AND SAMPLES AND THE
WHOLE IDEA IS TO ENHANCE
DEVELOPMENT OF BIOMARKERS THAT
CAN BE USED IN TESTING NEW
THERAPIES AND FINDING TARGETS
THAT MIGHT BE ACCESSIBLE FOR NEW
TREATMENT DEVELOPMENT.
THE ALS PUBLIC-PRIVATE
PARTNERSHIP ALSO HAS HEAVY
INTERACTION WITH THE FDA AND
THROUGH THE CRITICAL PANEL
NETWORK HAVE A DATA SYSTEM THAT
BRINGS DATA IN THAT INFORMS
REGULATORY PROCESSES IN ALS.
IT'S AN EXCITING PROGRAM THAT
APPROPRIATION HAS ALLOWED US TO
DO.
SO THAT'S THE FUNDING.
THOSE ARE THE FUNDS WE HAVE TO
WORK WITH.
I WANT TO TALK TO YOU A LITTLE
BIT ABOUT WHERE THE FUNDS ARE
GOING.
SO THE MAJORITY OF OUR FUNDS GO
TO COMMITMENTS WE'VE ALREADY
MADE.
SO NON COMPETING RPG GRANTS.
WE'RE HEAVILY INVESTED IN
DISCOVERY SCIENCE AND SUPPORTING
THE RPG COMPONENT OF OUR
PORTFOLIO.
BUT WHEN WE FUND A GRANT WE
USUALLY FUND THEM FOUR OR FIVE
YEARS.
SO MOST THE MONEY IS THEREFORE
OUTSIDE AND COMMITTED TO
RESEARCH THAT'S BEEN PREVIOUSLY
APPROVED.
THEN WE HAVE THE RPG COMPETING
POOL YOU CAN SEE HERE WHICH IS
17.5% AND THOSE ARE THE FUNDS
THAT YOU'LL BE SEEING ASSOCIATED
WITH THE GRANTS COMING BEFORE
YOU TODAY.
WE ALSO HAVE THE MANDATORY SPIR,
STTR PROGRAM WHICH IS ABOUT 3.8%
OF THE BUDGET.
WE HAVE A COUPLE OF CENTER
PROJECTS.
WE INVEST HEAVILY IN CAREER
TRAINING AND DEVELOPMENT AND A
COUPLE CONTRACTS.
THAT'S REALLY WHAT THE PIE CHART
LOOKS LIKE.
WE'LL SEE A LITTLE BIT MORE OF A
BREAK DOWN IN A SECOND.
BUT THE POINT ON THE RIGHT SIDE
OF THE SCREEN SHOWS THE INCREASE
IN THE COST TO PAY THE
NON-COMPETING COMMITMENTS FOR
GRANTS THAT ARE ALREADY BEEN
APPROVED AND OUT THERE.
SO THAT'S THAT DARK GREEN BAR.
YOU CAN SEE THEY INCREASE
SUBSTANTIALLY FROM '23 TO '24.
NOT ONLY DO WE GET AN INCREASE
BUT OUR MORTGAGE IS UP HIGHER
THAN IT WAS BEFORE IN TERMS OF
PAYING THINGS THAT ARE ALREADY
COMMITTED.
AND WE'RE GOING TO TRY TO HOLD
THAT LINE SO '24 TO '25 YOU
CAN'T REALLY ACCEPT MUCH OF AN
INCREASE IN THE NON-COMPETINGS
AND SO WE HAD TO DO SOMETHING
WHICH WE'LL TALK ABOUT TO MAKE
THAT HAPPEN.
OKAY.
SO AGAIN, THIS IS A LITTLE BIT
OF A SIMILAR BUT MAYBE MORE
DETAILED BREAKDOWN OF WHERE OUR
'23 GRANTS WENT TO.
SO THE DARK BLUE ARE THE RO1s
AND THAT'S THE SIGNATURE COIN OF
THE REALM FOR NINDS.
>> I HAVE A QUESTION WITH THE
LAST SLIDE.
THE ONE BEFORE.
NOT THE VERY LAST SLIDE, THE
SLIDE BEFORE LAST.
IF YOU CAN'T GO BACKWARDS I CAN
CRAFT THE QUESTION.
IT WAS THE GREEN BARS -- ONE
MORE.
I'M TRYING TO UNDERSTAND WHY THE
GREEN BAR IS A FRACTION OF THE
BUDGET.
WHY WOULD IT INCREASE?
THE PAY LINE REALLY HASN'T
INCREASED OR GONE UP THE LAST
SEVERAL YEARS.
SO THE NUMBER OF GRANTS
COMMITTED HASN'T BEEN CHANGING
AT ALL AND THE AMOUNT OF
MONEY -- IS IT BECAUSE THE
AMOUNT OF MONEY BEING ASKED FOR
IN THE GRANTS KEEPS GOING UP?
>> HOLD ON TO YOUR HORSES.
>> AND KATE HAD A QUESTION.
>> OKAY.
BEFORE WE GET THERE HERE'S THE
MONEY DISTRIBUTED TO ROV --
RO1s IN THE DARK BLUE.
THE ROE 1 EQUIVALENTS AND THE
R35s ARE FOR FOLKS WHO ARE RO1s
AND CAN'T SUBMIT ANOTHER RO1, SO
IN FACT THEY'RE PEOPLE WHO WOULD
ALMOST 100% LIKELY TO GET AN RO1
BUT PULLED OUT OF THAT POOL.
THAT AMOUNTS TO JUST A LITTLE
UNDER A PERCENTILE POINT ON THE
PAY LINE.
THEN YOU CAN SEE THE FUNDING
THAT WE HAVE IN THE DARK GREEN
IS A NETWORK CLINICAL TRIALS AND
THEN THE LIGHTER GREEN IS THE
NON-NETWORK CLINICAL TRIALS AND
OTHER CLINICAL RESEARCH IN THE
LIGHTER GREEN.
SO YOU CAN SEE THE CLINICAL
TRIALS TROPICAL STORM IT WILL
NOT A LARGE PROPORTION OF OUR
PROGRAM.
NOW, WE GET BACK TO TIM'S
QUESTION.
SO, IF WE LOOK WHAT THIS GRAPH
SHOWS YOU IS HOW MUCH MONEY
WOULD IT TAKE TO INCREASE THE
PAY LINE BY 1 PERCENTILE?
SO RIGHT NOW WE'RE IN THE 11
PERCENTILE AND HOPE TO NEVER GO
BELOW 14 PUT WERE PUSHED TO DO
THAT BECAUSE AS YOU CAN SEE HERE
THE AVERAGE COST OF THE PAY LINE
REALLY WENT UP HIGH.
AND IT'S BEEN GOING UP FOR YEARS
WITH 2016.
IT'S BEEN MATCHED BY AN INCREASE
IN THE FUNDING BECAUSE WE KEPT
GETTING INCREASES EVERY YEAR TO
MATCH INFLATION.
BUT THAT DID NOT OCCUR IN THE
CURRENT SITUATION.
NOW, THE LIGHT GREEN LINE SHOWS
THE ADJUST FOR THE INFLATIONARY
COST OF DOING SCIENCE, WHAT YOU
SEE IS PRETTY MUCH FLAT ACROSS
THE BOARD.
SO THE INCREASE WE THINK THE
CONCLUSION HERE IS THAT THE
INCREASE IN THE COST OF THE PAY
LINE POINT IS RELATED TO THE
FACT THAT IT'S JUST MORE
EXPENSIVE TO DO SCIENCE AND IT'S
INFLATION THAT DRIVES THAT UP
BUT WHEN YOU GET A FLAT BUDGET
YOU CAN'T HANDLE THAT AND IT HAS
TO COME FROM THE AVAILABLE FUNDS
FOR COMPETING GRANTS.
SO THAT IS WHAT THE ANSWER TO
TIM'S QUESTION IS AND WE'LL SEE
A LITTLE BIT MORE ABOUT A
BREAKDOWN OF HOW THAT LOOKS.
>> I'M CURIOUS SINCE WE HAVE
PROJECTIONS GOING FORWARD, ONE
OF THE BIG THINGS I KNOW ACROSS
THE COUNTRY EVERYONE INTRAMURAL
AND MINIMUM SALARIES HAVE TO GO
UP AND IS THAT IN THE
PROJECTIONS ALREADY THERE'LL BE
70 MINIMUM OR NOT EVEN THAT JET?
-- THAT YET?
>> SO, WE'LL GET MORE IN THE
FINANCES BUT I WANT TO STOP AND
GO THROUGH WHAT OUR PHILOSOPHY
WAS IN GOING FORWARD IN A TOUGH
BUDGET TIME.
THAT PHILOSOPHY WAS SHAPED BY
DISCUSSIONS AROUND THE TABLE
OVER THE YEARS.
SO I THINK AT NINDS WE'VE BEEN
COMMITTED TO WHAT WE CALL
PROTECTING THE PAY LINE.
WHEN I CAME IN 2007 WE HAD JUST
UNDER GONE A HORRIFIC DROP TO
LIKE 7 PERCENTILE, 8 PERCENTILE
PAY LINE AND WE AT THE STORY AND
I AND BOB WE SAID WE HAD TO DO
EVERYTHING WE CAN TO GET IT UP
AND WE MADE SOME CONVENTION THAT
WE NEVER WANTED TO GO BELOW 14.
THAT NUMBER CAN BE DEBATED.
BUT THAT WAS JUST A CONVENTION
THAT WE MADE AND WE WERE ABLE TO
DO THAT FOR MANY YEARS.
NOW, THE BUDGET WAS FLAT BETWEEN
2004 AND 2016.
I MUST SAY IN 2016 WE WERE
BASICALLY RUNNING OUT OF THINGS
TO CUT TO BE ABLE TO MAINTAIN
THAT.
WE WOULD HAVE DROPPED
SUBSTANTIALLY IN 2016 SHOULD WE
HAVE NOT GOTTEN AN INCREASE
BECAUSE WE RAN OUT OF THINGS WE
COULD CUT.
SO NOW WE'RE DOWN TO 11.
SO WE'RE WAY BELOW WHAT WE WANT
AND WHERE WE DECIDED WE WOULD
NEVER GO.
AND THAT AS YOU'LL SEE IS
DESPITE A LOT OF THINGS WE DID
TO INCREASE THE FUNDS AVAILABLE.
OUR PHILOSOPHY HAS BEEN THE
SCIENCE DEPENDS ON THE PEOPLE
DOING THE SCIENCE AND SO WE
THINK WE ARE THERE TO FUND AS
MANY OUTSTANDING INVESTIGATORS
AS POSSIBLE.
SO IN DISCUSSIONS HERE IN THE
PAST AND WE ASCRIBE TO THIS THAT
IF THINGS GET TIGHT IT WOULD BE
BETTER TO KEEP FUNDING AS MANY
PEOPLE AS WE CAN WHO ARE REALLY
GOOD AND DOING GOOD WORK AND
GOOD SCORES ON THE GRANTS AT THE
NEGATIVE SIDE OF CUTTING THE
PROJECTS AND THE COST PER
PROJECT.
SO THAT'S KIND OF WHAT WE'RE
GOING TO BE TALKING TO YOU ABOUT
IS MOVING THIS PHILOSOPHY TO GO
INTO ACTION AND TRY TO KEEP THE
COST OF THE GRANTS DOWN SO WE
CAN IT -- BUT THE REASON IS WE
WANT TO FUND AS MANY AS WE CAN.
WE WANT TO UP HOLD OUR
COMMITMENT NOT TO MORTGAGE THE
NEUROSCIENCE EFFORT BY CUTTING
OUT A GENERATION OF PEOPLE AND
MAKE IT HARD FOR ANYBODY TO GET
INTO SCIENCE.
THAT'S GOING TO REALLY HURT OUT
DOWN THE LINE IF WE GET AN
INCREASE IN THE FUTURE AND FOLKS
HAVE LEFT THE FIELD.
IT'S NOT GOING TO BE SOMETHING
THAT'S EASY TO BRING THINGS
BACK.
AND IN TERMS OF WHAT WE DO, WE
TALKED ABOUT THIS THAT WE FOCUS
PRIMARILY ON BASIC NEUROSCIENCE,
UNDERSTANDING HOW THE BRAIN
NERVOUS SYSTEM WORKS AND
UNDERSTANDING MECHANISM OF
DISEASE AND 65%, SOMETIMES 70%
OF OUR MONEY GOES TO THAT LEVEL
OF SCIENCE.
THE REASON IS BECAUSE IF WE
DON'T DO IT, PRETTY MUCH NO
ONE'S GOING TO DO IT AND
EVERYTHING ELSE IN TERMS OF
THERAPY DEPENDS ON THE
FUNDAMENTAL SCIENCE.
WE THINK THAT'S IMPORTANT AND WE
DO THINK WE NEED MECHANISMS THAT
WILL LEAD FROM THE DISCOVERY
THROUGH THIS PATHWAY OF
DEVELOPING THERAPIES OR
DIAGNOSTICS AND THEN TESTING
THINGS IN PATIENTS.
SO WE DON'T FEEL WE CAN CUT OUT
A BIG COMPONENT OF WHAT WE DO
AND SAY WE JUST CAN'T DO
CLINICAL TRIALS ANYMORE OR BASIC
MECHANISM OF DISEASE ANY MORE.
WE THINK EVERYTHING HAS TO BE
SHRUNK DOWN A BIT WITH THE
EXCEPTION OF THE TRAINING.
SO IF WE HAD OUR PHILOSOPHY TO
FUND AS MANY OUTSTANDING
RESEARCHERS AS POSSIBLE AN
INCREASING NUMBER LOOKS LIKE IT
MAY EVEN DOUBLE BETWEEN 1998 AND
NOW AND SOME OF THIS IS DUE TO
FUNDING SOURCES LIKE HEAL
INITIATIVE OR BRAIN INITIATIVE
BUT EVEN THE BASE BUDGET WAS
SUPPORTING MANY MORE SCIENTISTS
THAN IT HAD BEEN IN THE PAST.
SO THESE ARE THE FOLKS THAT --
>> HOW DOES THAT COMPARE TO NIH
WIDE?
>> I THINK IT'S ALSO GONE UP.
I DON'T REMEMBER THE STEEP
PIECE.
BUT NIH WENT UP AS WELL.
SO, THIS IS SHOWING YOU THE
DIFFERENT YEARS, '22, '23, '24
AND IN '24, IF WE DIDN'T CHANGE
OUR CUTS TO THE NON-COMPETING
GRANTS WE WOULD HAVE HAD $283
MILLION FOR NEW GRANTS COMPARED
TO $369 WE HAD IN 2023.
WHAT WE DECIDED TO DO IS CUT ALL
NON-COMPETING GRANTS BY AN
ADDITIONAL 3%.
WE CAN DO THAT BECAUSE WE WERE
PREVIOUSLY IN A CONTINUING
RESOLUTION WHERE INSTITUTIONS
ONLY RECEIVE 90% OF WHAT THEY
HAD EXPECTED BASED ON THEIR
BUDGETS.
SO INSTEAD OF SCORING THE
ADDITIONAL 10% WE'RE ONLY GOING
TO RESTORE 7%.
THAT ENABLED US TO INCREASE THE
AMOUNT OF FUNDS WE HAD FOR
COMPETING GRANTS UP TO $320
MILLION.
SO ABOUT HALFWAY -- A LITTLE
LESS THAN HALFWAY TO WHERE WE
WERE IN 2023.
THAT MONEY GOES TO WITHIN THE
PAY LINE GRANTS AND ALSO TO
GRANTS NOT PERCENTILE.
THEY'RE OUTSIDE THE PAY LINE OR
GRANTS THAT WE FUND THAT ARE
ABOVE THE PAY LINE.
NOW, YOU CAN SEE ON THE FINAL
ROW WHAT WE HAD DONE IN THE PAST
BECAUSE YOU ALWAYS HAD THIS
UNCERTAINTY OF WHAT THE BUDGET
WAS PAY THE R21s WHICH ARE
TWO-YEAR GRANTS AND PAY ALL OF
THEM IN ONE YEAR.
THEY WOULDN'T HAVE OUTYEAR --
OUT YEAR COSTS AND THAT WOULD
GIVE A BUFFER.
WE CAN'T DO THAT THIS YEAR
BECAUSE WE DON'T HAVE BUFFER
MONEY.
IN 2025 WE'LL BE SHORT THE MONEY
FROM 2024 THAT WAS BUFFERED BY
PAYING THE R21s IN '23.
A WORSE PROBLEM IN 2025 THAN WE
ARE IN 2024.
>> I THINK TIM HAS ANOTHER
QUESTION.
>> THAT'S WHY WE INCREASED THE
ADMIN CUTS BY 3%.
THE PROBLEM AT OUR INSTITUTE IS
SOMEWHERE IN THE DISTANT PAST,
MAYBE 2004, THE INSTITUTE
INCREASED THE ADMIN CUTS ON RO1s
TO 17.5%.
THEY ALSO INCREASED THE ADMIN
CUTS TO MODULAR GRANTS I THINK
1
12.5%.
OVER TIME WE GOT RID OF THE
MODULAR CUTS BUT NEVER GOT RID
OF THE ADMIN CUTS TO THE RO1s SO
NOW THE CUT IS 20.5% WHICH IS
NOT WHERE YOU WANT TO BE.
I DON'T THINK WE HAD ANY CHOICE
THIS YEAR.
CERTAINLY IT'S SOMETHING FROM
THE FUTURE TO TRY TO REDUCE
THOSE SHOULD THERE BE ANY
RELIEF.
SO WE DID INCREASE THE ADMIN
CUTS, GAINED A LITTLE BIT OF
MONEY FOR NEW GRANTS AND IF WE
WEREN'T THERE SWEET BE AROUND 8%
TO 9%.
THIS IS TO THE COST OF AN RO1
GRANTS.
THE BULK GO TO RO1 GRANTS.
I'M SURE THIS INCREASE IS NOT
JUST TO RO1s BUT AFFECTS ALL
GRANTS BECAUSE OF THE THINGS TIM
SAID, COST GO UP AND SALARIES GO
UP AND PARTICULARLY LATELY.
SO, WHAT YOU CAN SEE IS THERE'S
BEEN A MAJOR INCREASE IN THE RO1
GRANTS.
WHEN I CAME IN 2007 IT WAS
SOMEWHERE AROUND $380,000 MAYBE
FOR THE AVERAGE TOTAL COST AND
NOW IT'S $564,000.
THAT'S BEEN GOING UP
CONSISTENTLY LATELY DUE TO
INFLATION AND IF YOU ADJUST FOR
INFLATION IT'S REALLY PRETTY
FLAT.
AGAIN IT LOOKS LIKE IT'S DRIVEN
PRIMARILY BY INFLATION BUT THE
TRUTH OF THE MATTER IS WE'RE
GOING TO INCREASE THE PAY LINE
TO 14 YOU CAN'T AFFORD TO PAY
INCREASING COST PER GRANT.
WE HAVE TO FIGURE OUT HOW TO GET
THE AVERAGE COST PER GRANT DOWN.
WHICH IS REALLY HARD.
YOU CAN'T GET THE SAME THING YOU
WERE GETTING BEFORE IF YOU'RE
NOT GIVEN THE SAME AMOUNT OF
FUNDS.
WE'RE LOOKING PROBABLY FOR MORE
GRANTS THAT ARE LOWER COST AND
THIS IS THE PROJECTION GOING
FORWARD AND I WANT TO THANK MIKE
HOWE AND HIS TEAM FOR DOING ALL
THE WORK IN PREPARING THE DATA.
IT LOOKS LIKE BY 2026 THE
PROJECTION IS $612 ,000 IF WE
DON'T DO SOMETHING PER RO1 AND
THAT WILL BE REALLY TOUGH
WITHOUT SOME KIND OF BUDGET
RELIEF.
SO WHAT WE DID AS WE DECIDED TO
GO WITH A SPLIT PAY LINE.
AND I GUESS YOU WEREN'T HERE
WHEN THIS HAPPENED BUT WE WERE
TALKING ABOUT HOW DO WE DEAL
WITH THIS ISSUE OF FUNDING THE
RIGHT NUMBER OF PEOPLE AND UP
COMPARISON TO FUNDING LABS THAT
HAVE REALLY BIG BUDGETS.
AND THE DECISION OF THE COUNCIL
AND I THINK IT WAS A WISE ONE
WAS THAT IF IT'S A REALLY
IMPORTANT AND IT'S A SUPER
IMPORTANT REALLY GOOD GRANT, WE
SHOULD FUN IT NO MATTER WHAT.
NO MATTER HOW MUCH MONEY THEY
HAVE.
BUT IT'S GOT TO BE A REALLY GOOD
GRANT.
SO WE ESTABLISHED THE FACT THAT
IF YOU HAVE OVER $1 MILLION THEN
ALREADY IN YOUR LAB AND YOU'RE
GOING TO COME IN FOR FURTHER
MONEY, YOU HAVE TO GET BETTER
THAN HALF THE REGULAR
PERCENTILE.
THAT WAS 7 PERCENTILE AND WHAT
WE'RE DOING HERE WHERE IF THE
GRANT IS REALLY EXPENSIVE BUT
IT'S REALLY GOOD AND YOU CAN GET
BELOW THAT HALF OF THE REGULAR
PAY LINE AND WE'RE GOING TO FUND
IT, IT'S GOING TO BE JUST HARDER
TO GET THE MORE EXPENSIVE
GRANTS.
AND THAT IN FACT WHEN WE LOOK AT
IT IS NOT GOING TO HAVE A
TREMENDOUS IMPACT RIGHT AWAY ON
OUR BUDGET.
GIVE US SOME PUTTING RELIEF BUT
I THINK OVER TIME IT'S GOING TO
BE MORE OF A BEHAVIOR CHANGE
MODIFICATION THAT WILL REALLY
HELP US.
SO THAT'S KIND OF WHAT WE HAD
DECIDED TO DO.
SO THIS IS ACTUAL NOW YOU'RE
GOING TO BE SEEING THINGS COMING
TODAY THAT WE'RE THOUGHT GOING
TO BE ABLE TO FUND IF THEY DON'T
MAKE THIS GOOD PAY.
OKAY.
NOW, SO THAT WAS THE END OF THE
BUDGET TALK FOR EXTRAMURAL.
I JUST WANT TO ASK IF THERE ARE
ANY QUESTIONS.
>> GIVEN THE INCREASE OF THE
COST OF THE GRANTS AND
INSTITUTION CUTS AT NOW 20% IT
COULD BE A BIG CHUNK OF MONEY
MISSING IN THE GRANTS THAT GET
PAID.
AND THERE'S ON THE CUT UNLESS IT
WAS MORE THAN 25%.
I DON'T KNOW HOW THAT -- I THINK
THAT COULD BE CHANGED -- IT'S A
LOT OF MONEY MISSING NOW AND
GIVES ANOTHER OPPORTUNITY TO SEE
SMALLER VENUES AND BIG
FOUNDATIONS IN NEUROSCIENCE THAT
DIDN'T USED TO BE.
YOU COULD TAKE A CHUNK OF AN
IDEA AND SAY I'M GOING TO
REPURPOSE THIS AND TRY TO GET
MONEY WITH IT.
I REALIZE IT WILL BE A BIG ASK
BECAUSE IT'S A BIG NIH WIDE
POLICY FOR THE THRESHOLD FOR
REVIVING THE AIMS OF AN APPROVED
GRANT BUT NOW WE'RE TALKING
ABOUT SERIOUS AMOUNTS OF MONEY
BEING EXTRACTED FROM THE GRANT.
>> GOOD POINT.
IN OUR INSTANCE SINCE WE'VE HAD
THE 17.5% THE 3% ON TOP MAY NOT
NECESSARILY JUMP INTO THAT BUT I
THINK IT'S A GOOD POINT THAT IF
YOU GIVE PEOPLE LESS MONEY, YOU
HAVE TO EXPECT THEY'RE NOT GOING
TO DO AS MUCH NOW PARTICULARLY
WHEN YOU SUDDENLY IMPOSE IT.
I THINK OVER TIME PEOPLE WILL
HAVE TO KIND MUCH SHARPEN WHAT
THEY THOUGHT THEY'D BE ABLE TO
DO.
DAVE, DID YOU WANT TO SAY
ANYTHING?
>> NOT NECESSARILY.
THE THRESHOLD RIGHTS, PIPPEN --
OPINION IS WE HAVE DISCUSSED OUT
WITH OER AND WE WERE GOING TO DO
MASS ACTION CHANGE AND SHOULD BE
NIH WIDE NOT NINDS ALONE.
>> IT IMPACTS YOUNG PEOPLE
ENTERING THE SYSTEM MORE BECAUSE
I KNOW THE PHILOSOPHY THEY'RE
STARTING A LAB AND HAVE A SET OF
IDEAS, THEY'RE GOING TO SHOP
THEM AROUND.
EVERYBODY VIEWS THE FIRST RO1 AS
AN IMPORTANT METRIC BUT IF YOU
CAN'T GET IT ALL DONE, THEN THE
OPPORTUNITIES TO GET ALL THE
SMALLER OPPORTUNITIES AND SAY
LISTEN, I'M GOING PIGEON HOLE
THIS IN AND I THINK IT IMPACTS
THE ENTRY WORKFORCE MORE THAN
THE SENIOR.
>> SO, WALTER CAN YOU HEAR ME?
>> YES.
>> THANKS FOR THE OVERVIEW.
IT'S ALWAYS DIFFICULT TO FIGURE
OUT HOW TO DISTRIBUTE A FINITE
PIE.
I'M GOING TO GO BACK AND ASK
KIND OF A NAIVE QUESTION.
WHEN YOU TALK ABOUT THE
UNDIAGNOSED DISEASE PROGRAM IN
THE BASE BUDGET $2 MILLION AND
YET INSTRUCTED TO SPEND $18
MILLION.
TO WHAT EXTENT ARE YOU
INSTRUCTED TO DO THINGS WITH THE
MONEY THAT IMPEEDZ -- IMPEDES
THE WAY TO DISTRIBUTE THE PIE TO
THE INVESTIGATORS?
>> IT GOES UNDER UNFUNDED
MANDATES.
I DON'T THINK WE'VE HAD A LOT OF
THAT.
CONGRESS CAN TELL YOU WHAT TO DO
AND THAT THE SEPARATE FROM THE
AND NOT SOMETHING WE CAN ARGUE
WITH.
BUT I DOESN'T HAPPEN OFTEN.
>> NOT TO US.
>> WE HAD SOMEONE AT THE MIC
WHO'S BEEN STANDING.
>> GOOD MORNING.
IS THIS WORKING?
>> IF NOT YOU CAN COME HERE.
GOOD MORNING, MY NAME IS
DR. SHERYL LOMEN AND I'M AN
ADVOCATE AND REALLY UNDER THE
BUDGETARY PRESSURES YOU'RE UNDER
AND HOW YOU'RE TRYING TO STRIVE
TO BRING SOME MEASURE OF COMEN
SENSE IN THE BUDGET AND LONG
COVID.
WE ALL KNOW FROM CDC NUMBERS
THAT LONG COVID AFFECTS 16 TO 23
MILLION IN THE OUT.
ROUGHLY EQUIVALENT TO THE NUMBER
OF CANCER.
SENATOR SANDERS OF THE HEALTH
COMMITTEE AND OTHER BIPARTISAN
FOLKS ARE ASKING FOR A BILLION
DOLLAR MOONSHOT THAT WOULD BE A
THIRD OF YOUR BUDGET.
I PERSONALLY SAT DOWN WITH THE
BUDGETS AND UNDERSTAND THE COST
OF DOING SCIENCE AND THE AMOUNT
OF MONEY WE NEED TO DO
MEANINGFUL RESEARCH QUICKLY FOR
LONG COVID IS $10 BILLION
ANNUALLY.
THAT'S A HUGE AMOUNT OF MONEY.
MEANWHILE THOUGH WE NEED TO
REALIZE THAT THE ECONOMIC IMPACT
OF LONG COVID ON THE
U.S. ECONOMY BY A HARVARD
ECONOMIST IS $3.7 TRILLION.
SO I ASK THE ELEPHANT IN THE
ROOM, WHAT IS THE PLAN FOR
GETTING THE MONEY?
MY PLAN WAS STANDING IN THE RAIN
LAST NIGHT TALKING TO INCOMING
MEMBERS OF CONGRESS OF THE
PRIMARY.
WHAT'S YOUR PLAN?
THANK YOU.
>> WE HAVE A ROAD MAP FOR
RESEARCH LATER THIS MORNING.
BUT THE POINT IS WELL TAKEN THAT
THERE ARE TREMENDOUS HEALTH
PROBLEMS HITTING THE COUNTRY
THAT REQUIRE RESEARCH.
AND.
IN TOUGH BUDGET TIMES IT'S
DIFFICULT.
I WOULD SAY I TOOK THE SLIDES
OUT FOR THE SAKE OF TIME BUT OUR
INSTITUTE AND THE NIAID AND
NHLBI RUN THE RECOVER INITIATIVE
TO DO RESEARCH AND LONG COVID.
WE WERE HOPING THAT WE FIND A
CURE.
WE HAVEN'T DONE THAT YET BUT THE
GOOD THINGS THAT COME OUT OF
THAT THAT FUNDING IS AT THE TUNE
OF $1.5 BILLION.
THERE WAS FUNDING THAT CAME TO
NIH FOR THE LONG COVID RESEARCH
AND I SUSPECT AS MENTIONED IT'S
GOING TO TAKE A LOT MORE TO
SOLVE THE PROBLEM IT'S SO
SIMILAR TO WHAT YOU HEAR ABOUT
FROM ME/CFS AS FAR AS I CAN TELL
AND NOBODY'S BEEN ABLE TO FIGURE
OUT THAT DISORDER FOR DECADES.
BESIDES MONEY WE NEED PEOPLE
INVESTED IN THIS.
THAT IS ONE OF OUR BIG PROBLEMS
IN ME/CFS RESEARCH WE HAVEN'T
GOTTEN THE BIG POWERFUL RESEARCH
COMMUNITY INVESTED IN FIGURING
THAT OUT.
OKAY.
FLORIAN ANY QUESTION?
THIS NINDS IS FLAT AND NOT WITH
THE INITIATIVES OUTLINED AND HOW
DYNAMIC ARE THE INITIATIVES AND
HOW HARD IS IT TO LAUNCH NEW
ONES AND DO THEY COME ABOUT AND
WHAT'S THE FUTURE FOR THINGS
BEYOND BRAIN AND 21st CENTURY
CURES ACT AND ARE THERE THOUGHTS
AROUND GALVANIZING NEW
TECHNOLOGY AND REMEMBER SOME OF
THE TOPICS MENTION ED.
>> WE DON'T THINK THERE'S
ANYTHING WE DO NOT WORTHWHILE
DOING.
SO I THINK WE HAVE THE BASICALLY
THINK ABOUT SHRINKING EACH OF
THE PROGRAMS.
I THINK I TALKED ABOUT THIS LAST
TIME OUR TEAMS GOT TOGETHER AND
LOOKED AT WHAT THEY HAD HOPED TO
DO AND SO IF YOU HAVE A PROGRAM
YOU WANTED TO FUND FOR GRANTS
NOW YOU FUND TWO.
SO THAT'S KIND OF WHAT WE'VE
DONE AND THE TEAM SHAVED OFF
ABOUT $35 MILLION IN PLANNED
PROGRAMS.
WE DIDN'T JETTISON ANY CERTAIN
PROGRAM.
FOR NEW PROGRAMS, YOU'D HAVE TO
NOT DO SOMETHING ELSE AND TRIM
DOWN SOMETHING MORE TO DO
SOMETHING NEW.
WE HAVE PROGRAMS YOU'LL HEAR
ABOUT TODAY THAT ARE NEW
PROGRAMS PARTICULARLY IN TRYING
TO ADVANCE HEALTH EQUITY.
THAT'S A NEW PROGRAM.
WE HAD A WORKING GROUP OF
COUNCIL WORK ON THAT.
THE GENE THERAPY PROGRAM IS
ANOTHER ONE THAT WE'RE DEDICATED
TO MOVE FORWARD BECAUSE WE THINK
IT'S REALLY A PIONEERING SCIENCE
PROGRAM BUT IT'S GOING TO BE
DIFFICULT TO DO NEW THINGS.
>> SAMEER.
>> THANK YOU.
WITH POLICIES LIKE THIS PUTTING
MORE EMPHASIS ON COST THAN
PERHAPS BEFORE IN AN INTENTIONAL
WAY, HOW WILL THAT AFFECT, IF AT
ALL, REVIEW?
AN EXAMPLE WOULD BE TWO GRANTS
THAT ARE A FEW POINTS A PART BUT
ONE THAT IS A LITTLE BIT WORSE
AT SCORE BY A FEW POINTS IS 100K
LESS.
WHAT'S THE DOLLAR EQUIVALENT OF
AN IMPACT POINT, SCORE POINT?
I DON'T KNOW HOW OFTEN AT THE
PROGRAM LEVEL THEY GO WITH THIS
ONE IS CHEAPER AND IS THAT
COMMON AND IS THAT STILL A
PROGRAM LEVEL THING OR MOVE UP
TO REVIEW LEVEL PROCESS?
>> GOOD QUESTION.
I THINK OUR POLICY HAS BEEN IN
TERMS OF THE PAY LINE GRANTS
THAT WE DON'T GET INTO THAT.
WE FEEL THAT IF IT MEETS THE PAY
LINE, WE'RE GOING TO PAY IT.
SO, IN THIS INSTANCE IF IT'S
OVER 500K DIRECT COSTS WE NEED A
BETTER PAY LINE BUT WE'RE NOT
GOING TO SAY THIS ONE'S A LITTLE
BIT MORE EXPENSIVE SO WE'RE NOT
GOING TO PAY.
I THINK WE'RE TRYING TO
ESTABLISH A POLICY, STICK WITH
THE POLICY AND GO WITH WHAT PEER
REVIEW SAYS.
I WOULD SAY THAT THE OTHER THING
TO NOTE IS THAT ALL ALONG THE
POLICY AT NIH OVER ALL IS THAT
FOR ANY GRANT IT HAS TO GET
APPROVED TO COME IN.
WE HAVE HAD THAT PROCESS GOING
ON.
THERE'S MORE OF THOSE COMING IN
NOW THAN YOU CAN IMAGINE IT'S
MORE EXPENSIVE AND THAT'S WHERE
IT'S GETTING A LITTLE
NERVE-RACKING BECAUSE WE'RE
LOOKING AND SAYING WELL, IT'S
REALLY GOOD BUT IT'S EXPENSIVE.
SHOULD WE LET IT COME IN?
I PREFER THE SYSTEM OF GOING TO
REVIEW AND SEEING WHAT THE SCORE
IS THEN ME SAYING I DON'T LIKE
THAT ONE.
I FEEL PERFECTLY CONFIDENT DOING
IT BUT I DON'T THINK YOU WANT
SOMEBODY MAKING THOSE DECISIONS.
PEER REVIEW IS WHAT WE SHOULD
STICK WITH.
OKAY.
I WANT TO TALK AND MENTION ONE
MORE -- SORRY.
>> THANK YOU.
WITH RESPECT TO THE BUDGET
AGAIN, BUDGET IS NOT A SCORE
DRIVING POINT OF PEER REVIEW.
BUT I DO THINK THERE'S OFTEN
TIMES CASES WHERE WHEN REVIEWING
A GRANT, YES, OVER ALL IT'S VERY
GOOD BUT THERE'S A COMPONENT
THAT IS EXTREMELY EXPENSIVE AND
MAYBE UNNECESSARY.
HAS THERE BEEN ANY THOUGHT ABOUT
HAVING RATHER THAN JUST ACROSS
THE BOARD STANDARD BUDGET CUT
AND SPENDING MORE TIME LOOKING
AT VERY GOOD COMPONENTS OF
FUNDING GRANTS MORE EXPENSIVE
AND THAT'S AN IMPORTANT PART OF
IT.
>> RIGHT.
SO OUR PROGRAM PEOPLE DO THAT
AND SO IT'S NOT UNCOMMON THAT A
GRANT WILL COME IN AND THEY'LL
DECREASE THE AMOUNT OF MONEY
THEY'RE GOING TO GET.
MAYBE CHANGE SOMETHING THEY WERE
DOING.
THAT HAPPENS I THINK WE DON'T
WANT TO BE HEAVY HANDED ABOUT IT
BUT THAT DEFINITELY OCCURS.
I THINK WE'D LIKE TO STAY AWAY
FROM MICROMANAGING FOLKS.
>> OKAY.
I WOULD ADD SO IN THE REVIEW
ASPECT UNLESS IT'S A CONSENSUS
OPINION IT DIDN'T MAKE WHAT THEY
CALL THE ADMINISTRATIVE NOTE FOR
A CUT.
IF IT DOES, WE GENERALLY HONOR
THAT.
SO IF THE PANEL DO THING THINK
THERE'S SOMETHING EXCESSIVE FROM
IN THE GRANT AND AGREE ON IT AND
ASK FOR CONSENSUS MAKES IT
[INDISCERNIBLE]
>> THERE'S CERTAIN TYPES THAT
ARE MORE EXPENSIVE AND THAT'S
WHERE THE UNFAIRNESS COMES.
AND FIGURE OUT HOW TO DEVELOP A
POLICY THAT ADJUSTS FOR THAT.
THE INTRAMURAL PROGRAM ARE IN A
SIMILAR BOAT.
THEY HAVE A BUDGET THAT'S CAPPED
AND DON'T HAVE OPTIONS.
THEY HAVE SOME OPTIONS TO GET
OUTSIDE MONEY BUT IT'S PRETTY
LIMITED.
SO THE MONEY THAT'S AVAILABLE
FOR THEIR SCIENCE PROJECTS IS
DECREASING NOT -- WELL,
INFLATION IS ONE OF THE BIG
ONES, OF COURSE, BUT ALSO THE
INTRAMURAL BUDGET GETS TAPPED TO
SUPPORT EVERYTHING THAT GOES ON
AT NIH IN BETHESDA AND THE
CLINICAL CENTER FOR INSTANCE.
SO THEIR TAPS GO UP EVEN IN A
FLAT BUDGET SITUATION.
ABOUT $5.8 MILLION A YEAR.
THEY WERE GIVEN RELIEF IN 2024.
WE TOOK OVER THE ADMIN COSTS
WERE $4 MILLION BUT ARE NOT
GOING TO BE ABLE TO DO THAT
AGAIN UNTIL 2025.
SO THEY'RE ALSO LOOKING AT
POTENTIALLY SHRINKING THEIR
PROFILE FOR LAY-UP.
THEY'VE DONE A WHOLE BUNCH OF
THINGS TO NOT DECREASE THE
SCIENCE BUDGETS TO THE P.I.s.
I THINK THEY'LL GET BY IN '24
PUT MORE DIFFICULT IN '25 DUE TO
THE INCREASE IN THE TAPS AND NO
IN THE BUDGET.
THAT'S THE END OF THE BUDGET
TALKING AND WE HAVE OTHER
REPORTS AND HEAL WE GET $10
MILLION ADDITIONAL FUNDS AND IT
WAS RUN FROM THE OFFICE OF THE
DIRECTOR, DR. COLLINS AND
DR. TABAK RAN IT FOR THE FIRST
FIVE YEARS AND THEN MOVED TO THE
INSTITUTES, NINDS, NATIONAL
INSTITUTE OF DRUG ABUSE AND SO
ON THE PAIN SIDE IT'S A LITTLE
DIFFERENT THAN ON THE DRUG ABUSE
SIDE BECAUSE THERE'S AN
INSTITUTE FOR DRUG ABUSE BUT NO
INSTITUTE FOR PAIN BUT HEAL HAS
BEEN AMAZING TO BRING ALL THE
INSTITUTES TOGETHER TO DO THINGS
THAT NO ONE COULD DO ALONE IN
PAIN RESEARCH.
WE'RE PLANNING A STRATEGIC PLAN
TO HELP US LOOK FOR THE FUTURE
AND THIS IS IN THE BASE OFF THE
BUDGET AND PLEASED ROB JEREAUX
VOLUNTEERED TO WORK WITH THIS
AND WILL DEVELOP A WORKING GROUP
COUNCIL AND BRING THE STRATEGIC
PLAN BACK AND THEN IT WILL BE
WITH THE OTHER INSTITUTES THAT
ARE 14 INSTITUTES AND CENTERS IN
THE PAIN GROUP FOR HEAL AND
COORDINATED WITH THE STRATEGIC
PLAN FOR THE OPIOID CRISIS THAT
COMES OUT OF NIDA.
THE OTHER THING TO MENTION IS
THERE'S AN INTERESTING AMBITIOUS
PROGRAM WE'RE EMBARKING ON IN
THE HEAL INITIATIVE WHICH IS TO
ADDRESS THE HIGH RATES OF OPIOID
OVERUSE DEATHS AND CHRONIC PAIN
THAT OCCURS IN NATIVE AMERICAN
COMMUNITIES.
YOU SEE ON THE LEFT THE OPIOID
OVERDOSE DEATHS AND THEY'RE THE
WORSE GROUP IS AMERICAN INDIAN,
AMERICAN NATIVES.
IF YOU LOOK AT CHRONIC PAIN YOU
SEE THE SAME THING.
SO WORKING WITH NIDA WE HAVE A
PLAN WHICH HAS ALREADY BEEN
REVIEWED AND THE PLAN IS TO LOOK
AT PLANNING AND DEVELOPMENT IN
RESEARCH AND FUND THREE PROGRAMS
THAT WILL COORDINATE ACTIVITIAC,
GIVE TECHNICAL ASSISTANCE TO THE
TRIBAL NATIONS AS WITH IT -- AS
WE WORK WITH THEM TO DEVELOP
INITIATIVES IN THE SPACE.
WE'LL HEAR FROM BRUCE REED THE
DEPUTY DIRECTOR OF THE CENTER
FOR SCIENTIFIC REVIEW ABOUT THE
CHANGE IN THE PEER REVIEW
FRAMEWORK.
DR. NONI BURNS IS ILL TODAY AND
BRUCE REED HAS BEEN CLOSE TO THE
INSTITUTE AND THE DEPUTY
DIRECTOR THERE AND WILL BE ABLE
TO TALK TO US ON THE ISSUES.
THERE'S AN EXECUTIVE ORDER ON
ADVANCING WOMEN'S HEALTH
RESEARCH AND NIH IS HEAVILY
INVOLVED AND LOOKING TOWARD
DEVELOPING AMBITIOUS PROJECTS
IMPROVING WOMEN'S HEALTH.
RIGHT NOW THERE WAS NOT THE
FUNDING BUT THE HOPE IS THE
FUNDING WILL BE COMING IN YEARS.
THERE'S A NOTICE OF SPECIAL
INTEREST NOW FOR WOMEN'S HEALTH
RESEARCH THAT'S OUT AND THIS IS
SOMETHING DR. MONICA BERTAGNOLLI
THE NIH DIRECTOR IS PUSHING
HARD.
IN ADDITION TO THE TOP
PRIORITIES IS TO TRY TO
ESTABLISH A PRIMARY CARE
RESEARCH NETWORK IN THE
U.S. BECAUSE IF YOU LOOK AT OUR
COUNTRY'S HEALTH IT RANKS POORLY
COMPARED TO OTHER COUNTRIES AND
LACKING IN PREVENTATIVE CARE AND
THAT'S DONE PRIMARILY PRIMARY
CARE AND RESEARCH DONE IN
NEUROLOGY OR SURGERY.
THAT WOULD BE PERSON TO PULL
OFF.
THEY'RE GOING TO PUT IN $5
MILLION IN '24, $25 MILLION IN
'25 AND HOPEFULLY APPROPRIATIONS
OF LARGER AMOUNTS.
THERE'S A FUN ANNOUNCEMENT THAT
THANKS TO THE OFFICE OF RESEARCH
QUALITY WE'VE MADE MAJOR STRIDES
IN THE QUALITY OF RESEARCH AND
THE OFFICE PUT OUT A PRIZE
COMPETITION AND THE PRIZES FOR
RIGOR CHAMPIONS AND HATS OFF TO
THESE FOLKS CHO ARE REALLY DOING
GOOD WORK UP THEIR INSTITUTIONS
TO I AM IMPROVE THE QUALITY OF
THE SCIENCE THEY DO THERE.
WE HAD THE ME/CFS ROAD MAP AND
WILL BRING A REPORT FOR
DISCUSSION AND APPROVAL LATER
TODAY AND AGAIN CLOSELY TIED TO
THE LONG COVID PROBLEM.
I WANTED TO HIGHLIGHT THAT THE
INTRAMURAL PROGRAM DID A SMALL
NUMBER OF STUDIES GOING THROUGH
FINDINGS AND HAD TANTALIZING
RESULTS THAT NEED TO BE FOLLOWED
UP AND ON THE NEXT SLIDE TO
STATE BECAUSE OF THIS WORK AND
OTHER WORK DONE IN COVID AND
IMMUNOLOGY AND INFECTIOUS
DISEASE, HE WAS NAMED TO THE TOP
100 INDIVIDUALS WHO MOST
INFLUENCE GLOBAL HEALTH.
HOPEFULLY HE'LL GET HIS PICTURE
ON TIME MAGAZINE FOR THIS BUT
WE'RE PROUD OF AVI AND THE WORK
HE DOES AND THAT'S THE END EF
THIS DIRECTOR'S REPORT AND HAPPY
TO OPEN UP TO OTHER THOUGHTS OR
QUESTIONS OR ADVICE.
>> THANK YOU.
THE WOMEN'S HEALTH INITIATIVE
PLAN IS EXCELLENT.
IS IS ALZHEIMER'S AFFECTS WOMEN
MORE THAN MEN AND WILL BE CARVED
OUT?
>> I'M NOT SURE IN THE BEGINNING
STARTING OUT THEY'RE LOOKING AT
WHAT THE OTHER INSTITUTES ARE
ALREADY DOING IN THE SPACE AND
TRYING TO COORDINATE THERE MAY
BE PROGRAMS WE CAN LOOK INTO FOR
ALZHEIMER'S OR MULTIPLE
SCLEROSIS WHICH AFFECTS WOMEN
AND ME/CFS AFFECTS WOMEN,
CHRONIC PAIN, MIGRAINE JUST TO
NAME A FEW.
WE'RE LOOKING FOR OPPORTUNITIES
TO LOOK INTO WHAT COULD BE AN
IMPORTANT PROGRAM ACROSS NIH.
THE JURY'S OUT ON THAT QUESTION.
>> OTHER QUESTIONS?
>> THIS WAS DATA WE DISCUSSED
PREVIOUSLY AND YOU THOUGHT ABOUT
IT AND BUDGET WISE THERE'S AN
IDEA WE DISCUSSED ABOUT MAKING
STEEPER ADMINISTRATIVE CUTS IN
ORDER TO MAINTAIN PAY LINE.
I THINK THE THOUGHT HAD BEEN YOU
WOULDN'T BE ABLE TO SAVE ENOUGH
MONEY BY DOING THAT AND WOULD
HAVE TO REDUCE THE PAY LINE.
SO BRINGING UP AGAIN NOW WITH
THE REALITY THAT WE'RE IN WITH
THE BUDGET AND PERHAPS THE NEXT
ONE, IS THERE THOUGHT ABOUT THAT
REVISITING THE IDEA OF MAKING
AND IS THERE STILL -- OR IS IT
WORTH REVISITING THE IDEA OF
MAKING STEEPER CUTS TO OUT YEARS
FOR EXAMPLE IN ORDER TO AT LEAST
MAINTAIN OR MAYBE INCREASE THE
PAY LINE?
THE PROBLEM WITH THAT IS IT MAY
HAPPEN.
WE'D LIKE NOT TO DO IT BUT WE
WOULDN'T WANT TO DO IT THIS YEAR
BECAUSE ONCE YOU DO IT YOU CAN'T
DO IT AGAIN AND THEN YOU HIT THE
25%.
SO WE'RE AT 20.5%.
YOU GET TO 25% YOU HAVE TO REDO
THE SPECIFIC AIM OF THE GRANT
WHICH COULD BE PROBABLY NOT
POSSIBLE.
RATE NOW WE'RE HOPING TO STICK
WITH THE 2025, 11 PERCENTILE.
YOUR QUESTION IS IF WE WENT UP
ANOTHER 3% TO 23.5% CUT WE WOULD
THEN GET ANOTHER 1% TO 2%
PERCENTILE.
ONE OF THE PROBLEMS IS THE
COMMITMENT BASE SOMETHING ABOUT
TRYING TO FLIP THAT, HOLD THAT
STEADY.
YOUR QUESTION IS ABOUT THE
RETURNING AND AS ROBERT MENTIONS
UNDER C.R. WE RELEASE AT 90% AND
RESTORE AS MUCH AS WE CAN.
THEORETICALLY, AS WE DO THE MATH
THAT IS UNDER DISCUSSION USUALLY
AND THE GOAL IS TO GIVE BACK AS
MUCH AS THE 10% OF THE FOLKS.
IT'S NOT SOMETHING WE DON'T LOOK
AT.
>> I DID MENTION ONCE WE GET
RELIEF WHAT WE'D LIKE TO DO IS
GET THE REGULAR PAY LINE TO 14
AND PROBABLY GET THE SPLIT PAY
LINE BACK UP AND 14 AND 7 AND
TRY TO GET YOU BACK UP AND TRY
AND WORK ON THE OTHER CUTS FOR
SOME CEILING.
WE'LL HAVE A LIMIT AT 25.
'26 WHO KNOWS.
IT'S INTERESTING.
I THINK THE CHAMPIONS FOR NIH
MANY OF THOSE ARE RETIRED AND
THE VALUE OF NIH RESEARCH IS NOT
UNIFORMLY RECOGNIZED ACROSS THE
COUNTRY.
SO, I THINK THE ONE THING WE
SHOULD ALL BE THINKING ABOUT IS
HOW TO BEST COMMUNICATE THE
VALUE OF THIS INVESTMENT IN NIH
AND THE PROCESSES.
AND THAT MEANS TALKING TO PEOPLE
WHO DON'T NECESSARILY AGREE WITH
US TO TRY AND CONVINCE THEM OF
THE VALUE AND THAT'S SOMETHING
THAT I THINK I'LL TAKE ANY
OPPORTUNITY I CAN TO TALK TO ANY
GROUP ABOUT WHAT WE'RE DOING.
WE CAN'T ELICIT FUNDS TO ANYBODY
BUT I THINK YOU GUYS
PARTICULARLY HAVE THE ABILITY TO
MAKE -- GET THAT MESSAGE OUT.
WHEN SOMETHING COMES UP LIKE
THIS THERE'S A LOT OF COMMOTION
ON THE OUTSIDE AND DEAD QUIET ON
THE INSIDE.
NOT SURE THE UNIVERSITIES ARE
SLEEPING OR DIDN'T THINK THERE
WAS SOMETHING THAT THEY COULD
TACKLE.
DISEASE GROUPS SAME THING.
AS THE BEEN TOUGH TIMES IN THE
PAST.
PEOPLE IN THE FIELD LONG ENOUGH
KNOW THE NIH BUDGET ALWAYS GOES
UP AND DOWN.
WE'LL GET THROUGH IT.
>> HELLO.
I WANTED TO REITERATE AND
UNDERLINE AND PUT IN ALL CAPS
WHAT YOU JUST SAID,
DR. KOROSHETZ IS I THINK WE
DON'T REALIZE AS SCIENTISTS HOW
IMPORTANT IT IS TO TALK TO THE
PUBLIC ABOUT WHAT WE'RE DOING
AND THE IMPORTANCE OF IT.
AND INSTEAD WHAT GETS HEADLINES
IS THE LACK OF RIGOR OR
DISAGREEMENT IF ONE SCIENTIST
FINDS ONE THING AND ANOTHER
FINDS ANOTHER.
AND WE'RE NOT MAKING HEADLINES
AS MUCH AS WE SHOULD ABOUT THE
AMAZING THINGS THAT WE ARE
DISCOVERING THE TAXPAYERS MONEY
IS FUNDING AND THE ADVANCES
WE'RE MAKING.
COMPARED TO 20, 30, 40, 50 YEARS
AGO IT'S A LONG-TERM INVESTMENT
AND NEED TO SHOW THE PUBLIC OUR
VALUE AND OUR WORTH.
WE PREACH TO THE CHOIR, WE TALK
TO EACH OTHER, WE WRITE OUR
PAPERS FOR EACH OTHER INSTEAD OF
ALLOWING THE PUBLIC TO SHARE IN
THE EXCITEMENT AND THE PROCESS
OF DISCOVERY.
I DON'T KNOW WHAT WE SHOULD DO
EXACTLY BUT I THINK WE NEED TO
START BUILDING IN TO OUR GRANT
MECHANISMS THIS PUBLIC FACING
PART OF WHAT REALLY IS OUR JOB
TO DISSEMINATE THIS INFORMATION
NOT JUST TALK TO EACH OTHER.
I INVITE ANYBODY TO RESPOND TO
ANY SPECIFIC IDEAS THAT YOU
WANT.
>> I HAVE LOTS OF IDEAS.
WE COULD TALK OFFLINE ABOUT
THIS, GINA BUT I THINK WE HAVE
TO DO SOMETHING.
WHATEVER WE'RE DOING IS NOT
WORKING.
AND WE TRIED TO GIVE INPUT BUT I
THINK -- I DON'T THINK THE
GOVERNMENT'S THE ANSWER HERE.
I THINK WE NEED TO BE PART OF
THE ANSWER BUT THE PEOPLE WHO
CAN MAKE A DIFFERENCE ARE THE
PEOPLE WHO ARE TRUSTED IN THEIR
COMMUNITIES.
NOT THE PEOPLE IN THE BELTWAY.
WE CAN ONLY GO SO FAR BUT IT'S
GOT TO BE A GROUND-UP TYPE OF
APPROACH.
>> THAT'S RIGHT.
>> MESSENGERS AND MESSAGES AND
WE FUND PEOPLE AROUND THE
COUNTRY.
WE DO HAVE A LOT OF MESSAGES OUT
THERE IF THEY WANT TO -- WE SAY
TALK TO THE GUY WHO IS MOWING
HIS LAWN ABOUT WHAT PEOPLE DO.
>> OUR NEIGHBORS AND HOLD PUBLIC
MEETINGS.
EVERY UNIVERSITY AND EVERY
RESEARCH INSTITUTE SHOULD HAVE
PUBLIC LECTURES REGULARLY,
ETCETERA.
THERE'S A LOT OF THINGS WE COULD
BE DOING THAT WE'RE NOT DOING.
PUT IT ON YOUTUBE AS MY SON JUST
SAID.
>> I THINK WE'RE DOING WELL WITH
TIME AND I BELIEVE OUR GUEST IS
HERE.
>> HI, DR. REED.
GOOD TO HAVE YOU HERE.
SO, I MENTIONED YOU IN OUR
INTRODUCTION.
SO BRUCE IS CSR DEPUTY DIRECTOR
AND HE PLAYS A MAJOR ROLE IN
PLANNING, COMMUNICATION AND
TRAINING OF CSR'S EFFORTS.
HE CAME TO NIH IN 2015 IN
NEUROSCIENCE AND DEVELOPMENT AND
AGING AND SO WE KNOW HIM WELL.
BEFORE JOINING NIH HE WAS
PROFESSOR OF NEUROLOGY AND THE
WITH A DRC AND LOOKED AT
ALZHEIMER'S DISEASE PATHOLOGY
AND ONE OF OUR FAVORITE TOPICS
AND ALSO A LICENSED PSYCHOLOGIST
PROVING PATIENT CARE IN THE V.A.
HEALTH CARE SYSTEM FOR 20 YEARS.
HE GOT HIS PD IN CLINICAL PSYCH
FROM STONY BROOK AND TRAINED AT
BRAINTREE AND WITH DOUG KATZ --
WERE YOU WITH DOUG KATZ?
>> YES.
>> GOOD FRIEND OF MINE AND BRUCE
WILL TALK TO US ABOUT THE
INITIATIVES AND STRENGTH OF PEER
REVIEW.
BRUCE, THANKS FOR COMING.
WE WISH NONI A SPEEDY RECOVERY.
>> THANKS, WALTER AND THANKS FOR
THE INVITATION TO BE HERE AND
TALK TO YOU ABOUT WHAT CSR HAG
-- HAS BEEN DOING.
I WANT TO START BY CONVEYING
NONI'S REGRETS AND MAKES IT A
PRIORITY TO TALK WITH COUNCILS
AND HEAR YOUR PERSPECTIVES BUT
WAS TAKEN ILL AND NONE OF YOU
WANT WHAT SHE'S GOT.
SHE SENT ME THE SLIDES AND I'M
HAPPY TO BE HERE.
LET ME START OFF WITH A FEW
WORDS ABOUT CSR TO ENSURE NIH
GRANT APPLICATIONS RECEIVE FAIR,
INDEPENDENT, EXPERT AND TIMELY
SCIENTIFIC REVIEWS FREE FROM
INAPPROPRIATE INFLUENCES AND WE
DO THIS AT SCALE.
IN FISCAL '23 NIH RECEIVED
79,000 GRANT APPLICATIONS,
60,000 OF THOSE WERE REVIEWED BY
CSR, ABOUT 76% OF THE TOTAL.
AND YOU CAN SEE THE BULK IS
REVIEW OF RO1s AND BUSINESS
APPLICATIONS AND FELLOWSHIPS.
THAT'S NIH WIDE.
[CAPTIONS RESUME]
[NO AUDIO]
INITIATIVES SOME OF WHICH WERE
FAMILIAR TO YOU OF COURSE,
BRAIN, HEAL TO INCLUDE SOME OF
THE OTHERS.
BUT IN FISCAL '23 WE RECOVERED
161 ONE OF THESE.
WE DO A LOT OF PEER REVIEW AND
WHAT I WANT TO EMPHASIZE IS CSR
IS DEEPLY COMMITTED TO MAKE THE
PEER REVIEW THE BEST IT COULD
BE.
AND IT'S BEEN GUIDED BY THIS
CONCEPTUAL FRAMEWORK YOU SEE IN
FRONT OF YOU.
SO NIH PEER REVIEW HAS THREE
CRITICAL COMPONENTS.
THERE'S THE STUDY SECTIONS
THEMSELVES.
SO GRANT APPLICATIONS COMPETE
WITH EACH OTHER WITHIN STUDY
SECTIONS.
SO, THE SCIENTIFIC SCOPE IS
CRITICAL.
IT NEEDS TO BE SCIENTIFICALLY
CURRENT AND SCALED AND UPDATED
AND NEEDS TO PROVIDE AN
APPROPRIATE COMPETITIVE CONTEXT
FOR ALL THE APPLICATIONS.
WE NEED THE WRITE REVIEWERS.
WE NEED REVIEWERS WITH
APPROPRIATE EXPERTISE AS A GROUP
THEY NEED TO BE DIVERSE AND WELL
TRAINED.
THEN YOU HAVE TO USE PROCESSES
THAT PROMOTE GOOD REVIEWS SO
THAT PROMOTING INTEGRITY AND
MITIGATING BIASES AND PROMOTING
EFFECTIVE EVALUATION AND FOR
EXAMPLE USING APPROPRIATE
CRITERIA THAT HELP REVIEWERS
MAKE THE JUDGMENTS THEY OUGHT TO
MAKE.
SO ALL THE INITIATIVES WE'VE
TAKEN ON ONE OF THESE THREE
THINGS DRIVEN BY -- WE TRIED TO
PERIMETER THEM USING THE CORE
OPERATING PRINCIPLES OF
TRANSPARENCY, USING DATA TO MAKE
DECISIONS AND BI-DIRECTIONAL
STAKEHOLDER INVOLVEMENT.
I WANT TO EMPHASIZE OUR STAFF.
THEY UNDER LIE EVERYTHING.
WE CAN'T DO OUT WITHOUT THE
PEOPLE AND WE HAVE INVESTED UP
STAFF TRAINING AND I WON'T TALK
ABOUT THAT TODAY.
WHAT I'LL TALK ABOUT IS THE
TOPICS TO MAKE A POINT HERE THAT
EACH OF THESE BEAR ON A CRITICAL
COMPONENT OF EXCELLENCE AND PEER
REVIEW.
SO LET'S START WITH ENQUIRE?
IT'S AN ACRONYM THAT LABELS THE
SYSTEMATIC PROCESS THAT CSR USE
TO ASSESS AND UPDATE STUDY
SECTIONS.
WE IMPLEMENTED THIS PROCESS IN
2019.
OF COURSE STUDY SECTIONS CHANGE
BEFORE THAT BUT THERE WAS NO
SYSTEMATIC WAY OF DOING THAT.
THERE WAS NO REGULAR SCHEDULED
PROCESS TO RE-EVALUATING THE
STUDY SECTIONS TO ADAPT TO
SCIENTIFIC EVOLUTION.
THE GOAL OF THE PROCESS IS TO
EVALUATE ABOUT 20% OF STUDY
SECTIONS IN A GIVEN YEAR OR ANY
GIVEN STUDY SECTION SHOULD COME
UM WITH EVALUATION ONCE EVERY
FIVE YEARS.
THIS IS A PROCESS DRIVEN BY
STAKEHOLDERS.
WE HAVE ROUGHLY 180 STANDING
STUDY SECTIONS.
GROUP THEM INTO SCIENTIFICALLY
RELATED CLUSTERS OF STUDY
SECTIONS AND SUBMIT THOSE
CLUSTERS ONE AT A TIME TO THIS
PROCESS.
SO LET ME EXPLAIN HOW THIS
PROCESS WORKS.
IT'S A MULTI-STAGE PROCESS.
NUMBER ONE AND PROBABLY THE MOST
CRITICAL PART OF IT IS THAT WE
ASSEMBLE SELECTED MEMBERS OF TO
THE SCIENTIFIC COMMUNITY WITH
BROAD SCIENTIFIC KNOWLEDGE THAT
TYPICALLY SENIOR PEOPLE WITH
BROAD EXPERTISE CUTTING ACROSS A
NUMBER OF STUDY SECTIONS UNDER
REVIEW.
WE GIVE THEM DATA AND GIVE THEM
SAMPLE ABSTRACTS, SO FORTH.
THEN WE GIVE THEM WHAT IS A
CHALLENGING AND I THINK
INTERESTING QUESTION WHICH IS TO
MAKE A RECOMMENDATION ABOUT WHAT
SET OF STUDY SECTIONS IS THE
BEST SET TO REVIEW THE ENTIRE
SORT OF SWATH OF SCIENCE IN
FRONT OF US.
SO STUFF THAT'S COVERED BY THAT
GROUP OF STUDY SECTIONS.
WHAT GROUP OF STUDY SECTIONS
WOULD BE THE BEST 1234 -- THE
BEST TO IDENTIFY HIGH-IMPACT
RESEARCH.
THEY WORK ON THIS FOR A COUPLE
DAYS AND COME UP WITH THEIR
RECOMMENDS.
WE THEN BRING THE
RECOMMENDATIONS IN A SECOND
STAGE TO AN INTERNAL NIH PANEL.
THESE ARE TYPICALLY SENIOR
PROGRAM PEOPLE, SOME REVIEW
PEOPLE AS WELL BUT THE KEY THING
IS THAT THEY NEED A BROAD.
WE DON'T WANT PEOPLE DEEPLY OR
OVERINVESTED IN A SINGLE NARROW
PORTFOLIO BUT HAVE A BROAD
PERSPECTIVE TO MAKE THESE
JUDGMENTS.
AND CSR BRINGS TO OUR OWN
COUNCIL AN WHAT STUDY SECTIONS
SHOULD BE.
AFTER, THERE'S STILL WORK TO BE
DONE AND GUIDELINES NEED TO BE
REFINED AND TEST THEM OUT AND
ONCE YOU GET THOSE FINALIZED YOU
MAY MOVE STUDY SECTIONS AROUND
TO GET PEOPLE WITH APPROPRIATE
EXPERTISE ON REVIEW PANELS AND
THEN PUBLISH THE NEW PANEL
GUIDELINES AND THE ROSTERS AND
EVENTUALLY GET MEETINGS HELD
INSTEAD OF STUDY SECTIONS.
THAT'S A LOT OF WORK.
IT TAKES 12 TO 18 MONTHS TO GET
DONE.
THIS IS A VERY HIGH-LEVEL
PROGRESS REPORT.
WHAT YOU SEE IS THE PAST FOUR
YEARS WE GOT TO 14 OF THESE
CLUSTERS.
THE ONCE IN GREEN ARE ALL DONE.
THE ONES IN YELLOW OR BLUE ARE
SOME STAGE OF THE PROCESS.
ONE OF THE THINGS THAT I WANT TO
EMPHASIZE ABOUT THIS IS IN
GENERAL IT DOES RESULT IN
CHANGE.
CHANGES OF THE NUMBER OF TIMES
AND THERE'S NOT ONE SIZE THAT
FITS ALL BUT WE DO SEE THE
EXTERNAL REVIEWS RESULT IN
CHANGES TO THE STUDY SECTIONS.
SO SOMETIMES IT'S INCORPORATING
CHANGES IN SCIENCE, SCIENTIFIC
DEVELOPMENTS SORTS YOU SEE
SPLASHED ON THE SCREEN HERE.
SOMETIMES IT'S BECAUSE THESE
PANELS AFTER REAL THOUGHTFUL
CONSIDERATION HAVE A DIFFERENT
IDEA HOW STUDY SECTIONS OUGHT TO
BE ORGANIZED, BY DISEASE,
TECHNIQUE, VARIOUS THINGS.
THEY DO MAKE CHANGES AND THAT'S
THE POINT OF THE SLIDE.
I DON'T WANT -- YOU DON'T NEED
TO WALK THROUGH ALL THESE LINES
BUT WHAT YOU'RE LOOKING AT HERE
THIS CAME FROM A RECENTLY
COMPLETED INQUIRY OF SOCIAL
BEHAVIORAL STUDY SECTIONS AND
THE OLD ONES ARE ON THE LEFT AND
NEW ONES ARE ON THE RIGHT AND
THE ARROWS MAP THE
CORRESPONDENCE.
WHAT YOU OUGHT TO SEE IS
MOVEMENT THERE.
YOU DON'T SEE A NICE ONE TO ONE
CORRESPONDENCE OF TOPICS AND
SPLIT UP AND REGROUPED IN A WAY
THAT I THINK IS HEALTHY AND THAT
WILL RESULT IN BETTER REVIEW.
LET ME TURN THEN TO A COUPLE
UPCOMING CHANGES THAT RELATE TO
THE PROCESSES THAT WE USE IN
REVIEW MEETINGS.
THE FIRST OF THESE IS THERE WILL
BE CHANGES IN THE CRITERIA THAT
PEOPLE THAT REVIEWERS USE IN
EVALUATING RESEARCH PROJECT
GRANTS.
SO THE SIMPLIFIED REVIEW
FRAMEWORK FOR NIH RPGs.
SO, WHAT DOES THIS AFFECT?
RO1s, R21s AND MOST Rs WILL BE
AFFECTED BY REVIEW SO WHY CHANGE
THIS?
THE PRIMARY DRIVER OF THIS WAS A
DESIRE TO REFOCUS FIRST LEVEL
PEER REVIEW ON A SINGULAR ROLE
OF PROVIDING ADVICE TO THE
AGENCY REGARDING THE SCIENTIFIC
AND TECHNICAL MERIT OF GRANT
APPLICATIONS.
AND THE SIMPLIFIED FRAMEWORK
DOES THIS TWO WAYS.
IT REFRAMES THE CRITERIA TO
FOCUS REVIEWER ATTENTION ON
THREE KEY QUESTIONS.
THINK OF THESE IN SIMPLE FORMS.
SHOULD IT BE DONE?
CAN IT BE DONE WELL AND WILL IT
BE DONE?
SO THOSE ARE THE QUESTIONS THAT
REALLY YOU NEED TO EVALUATE.
IT REMOVES DISTRACTIONS OF
COMPLIANCE ITEMS THAT
COMPLICATED THE TASK.
WE HAVE THE CHANCE TO MITIGATE
REPUTATIONAL BIAS IN PEER
REVIEW?
BASICALLY, THE PHENOMENA WHERE
SOME GET A PASS AND OTHERS GET
EXTRA SCRUTINY.
EITHER IS FAIR.
BIAS DISTORTS ESTIMATES OF MERIT
SO IT DEGRADES REVIEW.
BOTH ARE AIMED AT FACILITATING
THIS OVER ARCHING GOAL OF PEER
REVIEW WHICH IS IDENTIFICATION
OF THE STRONGEST POTENTIALLY
HIGHEST IMPACT RESEARCH.
WHAT'S IT LOOK LIKE?
MOST WHO ARE DONE NIH REVIEW AND
PROPOSAL REVIEWS ARE FAMILIAR
WITH THE FIVE CRITERIA.
THEY DON'T GO AWAY BUT ARE
REDEFINED AND REORGANIZED.
INSTEAD OF RATING THE FIVE
CRITERIA AND REVIEWERS WILL WILL
BE ASKED TO RATE THREE FACTORS.
FACTOR ONE IS THE IMPORTANCE OF
THE RESEARCH.
IT WILL BE SCORED 1 TO 9.
FACTOR TWO ARE RIGOR AND
FEASIBILITY ALSO SCORED 1-9.
FACTOR THREE IS EXPERTISE AND
RESOURCES AND THIS ONE WILL BE
RATED AS EITHER APPROPRIATE OR
NOT APPROPRIATE AND IF NOT
APPROPRIATE REVIEWERS WILL BE
ASKED TO IDENTIFY WHERE THE GAPS
ARE.
THAT'S THE CORE OF IT.
THERE'S ADDITIONAL SCORE THAT
CAN IMPACT THE IMPACT SCORE.
THE MAIN THING TO EMPHASIZE IS
WE'VE ALWAYS HAD FOR THE LAST
FEW YEARS STUDIED TIME LINE AS A
CRITERIA FOR CLINICAL TRIALS.
AND INCLUSION CONSIDERATIONS,
WOMEN, MINORITIES FOR HUMAN
SUBJECTS CLINICAL TRIALS
RESEARCH.
THOSE HAVE BEEN MOVED BY THE
ADDITIONAL CRITERIA UP INTO
FACTOR TWO REFLECTING THE
SCIENTIFIC IMPORTANCE.
THEY GET MORE EMPHASIS UNDER THE
FRAMEWORK.
THEN, THIS IS IMPORTANT TO
EMPHASIZE ALL THREE FACTORS
IMPORTANCE OF THE RESEARCH AND
RIGOR AND FEASIBILITY AND
EXPERTISE IN RESOURCES ALL THREE
CONTRIBUTE TO THE OVER ALL
IMPACT SCORE.
CERTAIN ADMINISTRATIVE ITEMS
WERE REMOVED, SHARING AND BUDGET
AND EDUCATION PLAN AND CLINICAL
RESOURCES.
THAT'S IT IN A NUTSHELL.
IT'S WORTH EMPHASIZING THE
PROCESS THROUGH WHICH THIS WAS
DEVELOPED.
THIS GREW OUT OF A COUPLE OF
WORKING GROUPS ADVISORY TO CSR'S
COUNCIL.
THESE FOUR LARGELY EXTERNAL
PAPER ARE COUNCIL MEMBERS AND
PEOPLE WHO SERVED AS A WORK
GROUP AD HOC BASIS.
THEY GATHERED INITIAL INPUT FROM
THE PUBLIC FROM THE SCIENTIFIC
COMMUNITY THROUGH BLOG POSTS AND
THE RESULTING COMMENTS.
THEY GOT INPUT FROM OUR LEGAL
OFFICE AND EVENTUALLY MADE A SET
OF RECOMMENDATIONS TO CSR'S
ADVISORY COUNCIL.
THAT COUNCIL APPROVED IT AT
WHICH POINT CSR BROUGHT THIS TO
NIH AND VETTED THE IDEAS ACROSS
THE AGENCY GETTING ADDITIONAL
INPUT FROM STAKEHOLDERS AND A
NUMBER OF CHANGES HAPPENED AND
CAME TO THE I.C. DIRECTORS AND
LEADERSHIP OF NIH WHO APPROVED
THE FRAMEWORK.
AFTER THE CONCEPT WAS APPROVED,
NIH PUT OUT A REQUEST FOR
INFORMATION TO THE PUBLIC AND
THERE WERE PROFESSIONAL
SOCIETIES AND UNIVERSITIES.
THE MAJORITY WAS QUITE POSITIVE.
ONE INCORPORATING INVESTIGATORS
AND ENVIRONMENT SOMEWHAT
CONTROVERSIAL.
WE GOT SUPPORT FOR IT AND
CRITICISM IN A VARIETY OF
DIRECTIONS.
AND ONE OF THE MOST COMMON
COMMENTS WAS WE NEED TO WORK TO
SOCIALIZE THESE CHANGES.
SO THESE CHANGES ARE COMING AND
WILL GO INTO EFFECT FOR
APPLICATIONS RECEIVED AFTER
JANUARY 25, 2025.
GUIDE NOTICE WAS PUT OUT IN
2023.
THAT WEBSITE THERE IS A GOOD
SITE TO READ ALL ABOUT THE
CHANGES AND GET A LOT OF
INFORMATION THERE.
A TRANS-NIH COMMITTEE IS
IMPLEMENTING CHANGES THAT HAS TO
HAPPEN BUT CRITICALLY WE'VE
REALIZED THERE IS A REALLY LARGE
OUTREACH COMMUNICATIONS AND
TRAINING CHALLENGE ASSOCIATED
WITH THIS CHANGE THAT'S BEEN
MAPPED OUT IN GREAT DETAIL AND
IS ACTUALLY UNDERWAY AT THIS
POINT AND MORE INTENSE IN THE
COMING MONTHS.
ALL RIGHT THIS IS THE ADVISORY
COMMITTEE AD HOC.
LET ME SWITCH FROM THERE TO
ANOTHER SET OF CHANGES COMING
THAT WILL AFFECT THE APPLICATION
AND REVIEW OF FELLOWSHIP
APPLICATIONS.
SO, THESE CHANGES WERE MOTIVATED
BY THE DESIRE TO OPTIMIZE THE
IDENTIFICATION AND TRAINING OF
THE MOST PROMISING SCIENTISTS IN
THE NEXT GENERATION.
THEY WERE ALSO DRIVEN BY
CONCERNS WE HEARD A LONG TIME
YOU CAN BOIL DOWN TO BEING A
CONCERN THE NIH WAS POTENTIALLY
LEAVING OUT SOME PROMISING
RESEARCH SCIENTISTS BECAUSE OF A
REVIEW PROCESS THAT FAVORS LEAD
INSTITUTIONS AND SENIOR WELL
KNOWN SPONSORS.
CSR DID DATA ANALYSIS OF THE
APPLICATIONS RECEIVED IN 2021
AND TO HIGHLIGHT SOME THINGS
THAT CORRESPOND TO THAT HIGH
LEVEL OF CONCERN.
A SMALL NUMBER OF INSTITUTIONS
SUBMIT THE MAJORITY OF
FELLOWSHIP APPLICATIONS.
THE APPLICATIONS SUBMITTED BY
THOSE INSTITUTIONS DO BETTER IN
REVIEW AND REVIEW OUTCOMES FOR
FELLOWSHIPS IMPROVE AS THE RANK
OF THE SPONSOR GOES UP.
TO SHOW YOU BRIEFLY WHAT THIS
LOOKS LIKE.
SUBMISSIONS ARE HIGHLY
CONCENTRATED.
WE BEND INSTITUTIONS ACCORDING
TO THE NUMBER OF APPLICATIONS
SUBMITTED IN '21.
IF YOU LOOK AT THE RIGHT END OF
THE DISTRIBUTION YOU'LL SEE
THERE ARE 15 SCHOOLS EACH OF
WHICH SUBMITTED OVER 100
FELLOWSHIP APPLICATIONS.
LOOKING BACK TO THE LEFT END OF
THE DISTRIBUTION THERE'S 106
SCHOOLS THAT SUBMITTED ONLY ONE
OR TWO.
AND ALMOST ANOTHER 100 THAT
SUBMITTED BETWEEN THREE AND 10.
YOU CAN IMAGINE THE
INSTITUTIONAL KNOWLEDGE IT TAKE
TO SUBMIT AN APPLICATION IS
UNBALANCED.
YOU SEE THE APPLICATIONS FROM
SCHOOLS THAT SUBMIT A LOT OF
APPLICATIONS DO BETTER.
HERE WHAT YOU'RE LOOKING AT IS
REVIEW OUTCOMES FOR FELLOWSHIP
APPLICATIONS.
TOP BAR ARE THOSE THAT SUBMIT 1
TO 10 APPLICATIONS.
THE BOTTOM BAR ARE THOSE THAT
SUBMIT A LOT, 76 OR MORE AND THE
BLUE PART OF THESE GRAPHS MARKS
THE PROPORTION OF APPLICATIONS
THAT FALL IN THE HIGH IMPACT
GROUPS THAT GET OVER ALL IMPACT
SCORE IN THE HIGH IMPACT RANGE.
SO FOR THOSE SCHOOLS THAT DON'T
SUBMIT MANY, ABOUT 28% OF THEIRS
END UP IN THE HIGH IMPACT RANGE.
FOR THOSE THAT SUBMIT A LOT IT'S
44%.
IT'S A SUBSTANTIAL DIFFERENCE.
SO LET ME EMPHASIZE THE IDEAS.
THEY GREW OUT OF A CSR ADVISORY
COUNCIL WORKING GROUP COUNCIL
MEMBERS AND AD HOC SERVED AND
GOT RESULTING COMMENTS AND THEY
DID THE DATA ANALYSIS I REFERRED
TO AND THE ADVISORY COUNCIL WITH
A SET OF RECOMMENDATIONS.
COUNCIL APPROVED THOSE.
THOSE WERE THEN SHOPPED AROUND
AND VETTED ACROSS NIH WITH
APPROVAL FROM THE I.C. DIRECTORS
AND SENIOR LEADERSHIP LATER THAT
YEAR.
AGAIN, NIH PUT OUT A REQUEST FOR
INFORMATION TELLING THE PUBLIC
WE'RE THINKING OF DOING THIS AND
WHAT DO WE THINK AND IT TURNED
OUT TO BE USEFUL.
GENERALLY THE RESPONSE WAS WE
LIKE THE IDEA.
THERE ARE SOME THINGS NOT SO
CLEAR TO US.
THERE WERE QUESTIONS ASKING FOR
CLARIFICATION OF PROPOSED
CRITERIA.
THERE WERE QUESTIONS ASKING US
TO CLARIFY HOW THE APPLICATION
WOULD BE CHANGED AND FOR SEVERAL
MONTHS NIH WORKED TO INCORPORATE
THAT FEEDBACK AND MODIFY THE
RECOMMENDATIONS WHICH HAS BEEN
HAPPENED AND THIS PROCESS TOO IS
GOING FORWARD.
LAST MONTH THE HNIH ANNOUNCED TE
CHANGES TO THE REVIEW PROCESS
WILL HAPPEN.
LET ME BRIEFLY EXPLAIN IN TERMS
OF CHANGES.
THE FORMER FIVE CRITERIA ARE
BEING BOILED DOWN TO AGAIN
REFLECT THREE CRITICAL
CONSIDERATIONS THAT WE WANT
REVIEWERS TO THINK IN EVALUATING
FELLOWSHIP.
THE CANDIDATE'S PREPAREDNESS AND
POTENTIAL, THE QUALITY OF THE
RESEARCH TRAINING PLAN AND THE
COMMITMENT TO THE CANDIDATE.
SO THE CANDIDATE PREPAREDNESS
I'LL EMPHASIZE IS TO ENCOURAGE
REVIEWERS TO CONSIDER A WIDE
RANGE OF POTENTIAL AND
PREPAREDNESS NOT JUST
TRADITIONAL MARKERS OF EARLY
ACADEMIC SUCCESS.
THE COMMITMENT TO THE CANDIDATE
THIS ASKS REVIEWERS TO EVALUATE
THE SPONSOR IN THE ENVIRONMENT
IN TERMS OF WHAT THEY WILL
CONTRIBUTE TO THE APPLICANT'S
SCIENTIFIC TRAINING.
THESE ARE TRAINING APPLICATIONS.
THESE ARE TRAINING GRANTS.
THAT'S THE CORE OF IT.
THE SPONSOR'S EXTRAMURAL FUNDING
IS NO LONGER CONSIDERED BY PEER
REVIEW.
FOR FELLOWSHIPS THE APPLICATION
IS ALSO CHANGING.
TO OUTLINE THE CHANGES IT'S
ALIGNED WITH THE NEW REVIEW
CRITERIA THAT PUTS LESS EMPHASIS
ON SPONSOR TRACK RECORD AND MORE
EMPHASIS ON QUALITY OF THE
TRAINING PLAN AND INCLUDES A
CANDIDATE SELF-ASSESSMENT AND
STATEMENT ON THE SCIENTIFIC
PERSPECTIVE.
GRADES HAVE ALWAYS BEEN A SORE
SPOT.
THEY'RE NO LONGER REQUIRED OR
ALLOWED.
OVER ALL IT'S STRUCTURED AND
DOES A BETTER JOB OF WHO OUGHT
TO WRITE WHAT.
THE SPONSOR NEED TO DO PARTS AND
THAT'S BETTER LAID OUT IN THE
REVISED APPLICATION.
THESE CHANGES ARE COMING AND
COME INTO EFFECT FOR
APPLICATIONS DUE AFTER JANUARY
25, 2025.
FOR FELLOWSHIPS THAT WILL
TYPICALLY BE A DUE DATE OF APRIL
8, 2025.
GUIDE ON THIS IS OUT.
THERE'S A WEBSITE THAT INCLUDES
A LOT OF DETAILED INFORMATION
WE'RE WORKING HARD TO IMPLEMENT
ALL THE THINGS WE HAVE TO DO
INTERNALLY.
AGAIN, WE RECOGNIZE THE LARGE
OUTREACH AND COMMUNICATION AND
TRAINING CHALLENGE THIS CREATES.
THAT'S ALREADY UNDERWAY.
OKAY.
SO CHANGES IN THE PROCESSES.
THIS GROUP PUT TOGETHER THE
INITIAL CHANGE RECOMMENDATIONS.
SO, LET ME FROM HERE TURN TO A
NUMBER OF INITIATIVES DESIGN TO
PROMOTE FAIRNESS IN REVIEW.
THESE FOCUS ON THE REVIEWERS
THEMSELVES.
THERE'S SEVERAL THINGS WE'VE
DONE.
FIRST IS TRAINING CHAIRS.
WE HAVE 180 STUDY SECTIONS.
EVERY YEAR ABOUT 90 NEW CHAIRS
COME ON BOARD AND WE RUN A SET
OF NINE OR TEN SMALL GROUP
INTERACTIVE SECTIONS TO TRY TO
ORIENT THE INCOMING CHAIRS TO
THEIR ROLE.
ONE THING WAS FACILITATING
DISCUSSION AND TRYING GET THEM
TO APPRECIATE THEIR ROLE IN
PROMOTING FAIRNESS IN THE REVIEW
PROCESS.
FOR EXAMPLE, CHAIRS NEED TO
RECOGNIZE THEIR INFLUENCE.
THEY CAN SET AND CHANGE THE
CULTURE WITHIN A STUDY SECTION.
WE WANT TO LOOK AT
CONFIDENTIALITY AND INTEGRITY OF
COURSE BUT ONE OF LIVELY
INTERACTION FROM EVERYBODY
ACROSS THE ROOM ONE WHERE BIAS
STATEMENTS IF THEY APPEAR ARE
CALLED OUT AND DISCUSSED.
IT PROMOTES ON THE DISCUSSION OF
THINGS THAT REALLY MATTER.
THINK OF HOW IMPORTANT IS THE
SCIENCE?
HOW RIGOROUS AND FEASIBLE IS IT
AND ARE RESOURCES IN PLACE
FOCUSSING ON KEY QUESTIONS.
SO WE START WITH EDUCATING
ORIENTING CHAIRS TO THIS.
ANOTHER THING WE'VE DONE IS TO
IMPLEMENT AWARENESS AND
MITIGATION TRAINING.
THIS WAS DEVELOPED AND
IMPLEMENTED IN 2021.
PROBABLY MANY OF YOU HAVE TAKEN
IT I HOPE, AND IF YOU HAVE
YOU'LL NOTE IT'S TARGETED TO
MITIGATING THE MOST COMMON
BIASES IN THE PEER REVIEW
PROCESSES.
LOOKING AT REPUTATIONAL BIAS.
THIS IS NOT GENERAL IMPLICIT
BIAS TRAINING.
IT'S A 30-MINUTE TRAINING OVER
34,000 NIH REVIEWERS HAVE NOW
TAKEN.
GENERALLY, THIS HAS BEEN REALLY
WELL RECEIVED BY THE SCIENTIFIC
COMMUNITY WHICH SURVEYED AND WE
HAVE A GOOD BASE KNOWLEDGE ABOUT
THIS.
PEOPLE SAY NICE THINGS ABOUT
THAT.
MORE IMPORTANT IS IT HAVING AN
AFFECT.
IF YOU SURVEY THEM THEY SAY IT'S
HAVING AN AFFECT AND IF YOU ASK
THEM ABOUT THE IMPACT OF
TRAINING ON THEIR COMFORT ON
DOING SOMETHING IF THEY NOTICE
BIAS IN REVIEW, 90% SAY THE
TRAINING HELPED THEM FEEL EITHER
MORE COMFORTABLE TO A LARGE OR
MODERATE EXTENT.
BUT WE ALSO SEE THIS IN
REVIEWERS.
IN OBSERVING MEETINGS YOU SEE
INSTANCES WHERE PEOPLE ARE
CLEARLY IMPLEMENTING THE
TRAINING AND ANOTHER REVIEWER
WILL SAY DID YOU TAKE THE
TRAINING?
THIS IS EXACTLY WHAT YOU'RE NOT
SUPPOSED TO BE DOING AND
PROMOTES DISCUSSION.
THIS IS NOW REQUIRED FOR ALL NIH
REVIEWERS.
BEFORE A REVIEWER CAN REVIEW FOR
THE FIRST TIME THEY HAVE TO
UPDATE THE TRAINING.
AND WE HAVE A REVIEW INTEGRITY
TRAINING MODULE.
YOU MAY THINK INTEGRITY, WHAT'S
THERE TO TALK ABOUT THERE?
DON'T LIE, DON'T CHEAT BUT
REVIEWERS ARE COLLEAGUES WITH
APPLICA
APPLICANTS THAT OVERLAPPING ROLE
CREATES OPPORTUNITY FOR LAPSES
OF CONFIDENTIALITY AND ALL THIS
DOWN STREAM NEGATIVE EFFECTS OF
THAT.
AND SO THIS TRAINING REALLY
FOCUSES ON THE DUAL ROLES THAT
REVIEWERS HAVE.
SAY COLLEGIAL RELATIONSHIPS AND
WALKS THEM THROUGH TRICKY THINGS
THAT CAN COME UP.
OVER 30,000 REVIEWERS HAVE
COMPLETED THIS.
IT IS ALSO WELL RECEIVED, 90%
SAID THEY FEEL THEY HAVE A
SUBSTANTIAL INCREASE OF WHAT
THEY CAN DO TO COMMAND AND
REPORT INTEGRITY BREACHES AND
MORE COMFORTABLE CONTACTING NIH
WITH CONCERNS.
AND AGAIN, THIS IS NOT
REQUIRED -- NOW REQUIRED FOR ALL
NIH REVIEWERS.
YOU CAN REPORT INSTANCES OF BIAS
DIRECTLY TO CSR.
THAT'S THE E-MAIL THERE YOU SEE
ON THE SIGNATURE BLOCK OF ALL
SRO AND ALL OF OUR STAFF.
IF WE REVIEW THERE WAS BIAS
WE'LL REVIEW THAT IN THE SAME
COUNCIL ROUND.
THIS IS NOT GOING TO APPEAL JUST
SOMETHING BROUGHT TO OUR
ATTENTION, WE THINK IT WAS
FLAWED, WE'LL DO WHATEVER WE CAN
TO FIX IT IN THAT COUNCIL.
IF WE DISAGREE AND DON'T THINK
IT WAS A PROBLEM AND THE
OFFICIAL NIH APPEALS PROCESS IS
STILL OPEN NO THOSE INDIVIDUALS.
BUT WE DON'T JUST FIX THE
REVIEW, WE TRY TO FIX THE SOURCE
OF THE PROBLEM SO FOR EXAMPLEFUL
A REVIEWER SAID SOMETHING
BIASSED IN THEIR CRITIQUE, WE
ASK A DIVISION DIRECTOR TO GIVE
THAT PERSON A CALL AND HAVE A
CHAT.
IT'S NOT INTENDED TO BE A
SCOLDING CHAT.
IT'S SUPPOSED TO BE LIKE THIS IS
PROBLEMATIC AND WE UNDERSTAND
WHY IT WAS PROBLEMATIC AND HOW
YOU MIGHT APPROPRIATELY MAYBE
ADDRESS WHAT MIGHT BE THE
UNDERLYING CONCERN.
MOST THE CONVERSATIONS TWO THAT
WAY AND WE'RE TRYING TO AGAIN
SHAPE AWARENESS AND CULTURE.
TO EMPHASIZE YOU CAN REPORT ANY
PROBLEM THERE IN BIAS, INTEGRITY
ANYTHING.
WE'LL LOOK INTO IT.
THEN I WANT TO TURN TO CSI'S
EFFORTS.
THIS IS THE APPROACH WE'VE
TAKEN.
IT STARTS WITH TRYING TO MAKE
SURE EVERYBODY THAT IS OUR SROs
AND CHIEFS AND HOPEFULLY
REVIEWERS THEMSELVES UNDER THE
CRITICAL NEED FOR NIH TO HEAR
DIVERSE PERSPECTIVES.
THAT LETS REVIEWERS DO THE BEST
JOB OF FULFILLING PEER REVIEW'S
MISSION TO IDENTIFY THE BEST
SCIENCE.
SO THAT MEANS THE MOST EFFECTIVE
BEST WE ROUX COMMITTEES ARE
BROADLY DIVERSE AMONG MULTIPLE
DIMENSIONS.
RANGE OF PERSPECTIVES.
THESE INCLUDE DIVERSITY ALONG
SCIENTIFIC BACKGROUND
PERSPECTIVE AND GEOGRAPHIC
DIVERSITY, ARRANGE OF CAREER
STAGES AND A RANGE OF PRIOR
REVIEW EXPERIENCE.
THAT'S WHAT WE'RE LOOKING FOR ON
PANELS.
WE PAID ATTENTION TO THESE
THINGS PRETTY CAREFULLY ON STUDY
SECTION MEMBERS.
THE APPOINTED MEMBERS.
IN THE LAST FEW YEARS WE'VE
ENHANCED OUR SPECIAL EMPHASIS
PANELS WHERE EVERYBODY SERVES ON
IT ON A TEMPORARY BASIS.
SO THE GOAL IS TO RAISE
COLLECTIVE AWARENESS TO SET
EXPECTATIONS AND TO SHARE DATA
WITH OUR MANAGEMENT STAFF.
WE ALSO TRY TO PROVIDE TOOLS FOR
SROs.
THEY NEED THE TOOLS TO HELP THEM
FIND LESSER KNOWN REVIEWERS TO
TRY TO GET THEM OUT OF THEIR
MENTAL ROLODEX AND NEED PLACES
TO LOOK FOR NEW MEPEOPLE.
THIS IS ONE TOOL WE'VE CREATED
AND POINT I WOULD MAKE ABOUT
THIS IS WE'VE ASSEMBLED
POTENTIAL REVIEWERS OUT OF A LOT
OF SOURCES.
SOME ARE NIH'S BUSINESS SYSTEMS
BUT GOES OUTSIDE OF THAT.
FOR EXAMPLE, I.C. PROGRAM STAFF
CAN SUGGEST POSSIBLE REVIEWS.
PROFESSIONAL SOCIETIES CAN
SUGGEST REVIEWERS.
WE'VE ALSO LOOKED -- THERE'S A
CONCERN THAT ROOM YOU SHOULDN'T
HAVE TO HAVE NIH FUNDING TO
REVIEW NIH GRANTS.
SOUND LIKE A CLOSE LOOP.
WE REVIEWED POTENTIAL REVIEWERS
WHO ARE FUNDING FROM OTHER
AGENCIES WHO ARE FROM PROMINENT
PHILANTHROPIC ORGANIZATIONS IN
THE DATABASE.
AND THESE CHANGES UP AGGREGATE
DO MAKE A DIFFERENCE.
SO THIS SHOWS THE
REPRESENTATION -- THESE ARE A
COUPLE YEARS OF DIVERSITY ON OUR
STUDY SECTION.
FOCUSSING ON GENDER AND MINORITY
REPRESENTATION.
LET ME JUST HAVE YOU LOOK AT THE
RIGHT SIDE WHICH IS WHAT IT WAS
AS OF JANUARY.
SO IF YOU LOOK AT REPRESENTATION
OF WOMEN 34% OF THE P.I.s THAT
SUBMIT ARE WOMEN.
IN CONTRAST, 41% OF THE
REVIEWERS WHO SERVE ARE WOMEN
AND 45% OF APPOINTED MEMBERS ARE
WOMEN.
LOOKING AT UNDER REPRESENTED
MINORITIES THE FIGURE FOR P.I.s
APPLICATION TO CR ARE 9%.
IN CONTRAST WE HAVE 13% OF OUR
AD HOCS ON SEPS UNDER
REPRESENTED MINORITY AND 16% OF
THE APPOINTED MEMBERS ARE UNDER
REPRESENTED MINORITIES.
AND THE LINES DON'T GO STEEPLY
UP BUT THEY DO IF YOU LOOK AT
THEM CLOSELY, THEY'RE INCREASING
OVER TIME.
AND SO THIS IS SOMETHING WHERE
THERE'S MORE WORK TO BE DONE.
LET ME SHOW YOU ANOTHER EXAMPLE
OF THE CHANGING DIVERSIFYING THE
STUDY SECTION MEMBERSHIP.
SO HERE WE'RE CLASSIFYING
REVIEWERS ACCORDING TO THEIR
ACADEMIC RANK.
AND IF YOU LOOK BACK IN 2019,
74% WERE FULL PROFESSORS.
THAT'S THE LIGHT BLUE.
THE DARK BLUE ON THE BOTTOM WAS
ASSOCIATES AND THE VISIBLE GRAY
ARE ASSISTANTS, 1%.
IN 2023 IT HAD CHANGED QUITE A
BIT AS YOU SEE.
NOW, 45% AND 44% ARE ASSOCIATES
AND 8% ASSISTANTS.
LARGER DIVERSITY REPRESENTED IN
THE STANDARD SUBSECTION MEMBERS.
I'LL SAY BRIEFLY ANOTHER THING
WE'VE DONE AND THE PRESENT AT
EVERY STANDING STUDY SECTION AND
LOOK AT REDUCED LOAD BUT GET THE
VALUABLE FIRST HAND EXPERIENCE
OF SEEING HOW NIH REVIEW UNFOLDS
AND HOPEFULLY HELPS US BUILD
MORE DIVERSE POOL FOR FUTURE
REVIEWERS.
I'VE COVERED A LOT BUT THERE'S
MORE.
THIS IS ON OUR WEBSITE AND IF
YOU'RE INTERESTED IN ANY OF WHAT
I TALKED ABOUT TODAY YOU CAN
FIND DATA RELATED TO THIS ON THE
WEBSITE.
OR YOU CAN E-MAIL ME.
HAPPY TO CORRESPOND.
AND HAPPY TO TAKE QUESTIONS.
>> WE DID HAVE A COUPLE IN THE
CHAT.
WHY DON'T WE START THERE.
LOUISE.
>> I WAS VERY INTERESTED BY THAT
KIND OF GAP THE DELTA BETWEEN
31% FUNDED I BELIEVE IF YOU GO
BACK A SLIDE AND THEN OR 41%
REVIEWING OR JUST WANTED TO SEE
IF THAT'S THE SAME PROPORTION
FOR MEN OTHERWISE WOMEN MAY BE
DOING OR UNDER REPRESENTED
GROUPS MAY BE DOING ADDITIONAL
WORK SOMETIMES PEOPLE CALL IT
THE DIVERSITY TAX.
SO IF THEY'RE DOING WAY MORE
REVIEW WHICH IS VERY TIME
CONSUMING, ARE THEY GETTING THE
SAME BENEFIT?
I'M JUST WONDERING FOR MEN IS IT
THE SAME RATE 31% OR 41%
WHATEVER IT WAS FUNDED WERE 45%
WERE REVIEWING?
DOES THAT MAKE SENSE WHAT I'M
TRYING TO SAY?
>> I THINK I UNDERSTAND.
WOMEN AS A PROPORTION OF
REVIEWERS, WOMEN ARE OVER
REPRESENTED COMPARED TO
REPRESENTATION UP SUBMITTING
APPLICATIONS.
MEN ARE NOT.
UNDER REPRESENTED MINORITIES ARE
ALSO OVER REPRESENTED UPON
REVIEW PANELS RELATIVE TO THE
NUMBER OF APPLICATIONS THEY
SUBMIT.
>> SO, WE MAY NEED TO PAY
ATTENTION TO THAT THOUGH THE
NUMBERS OF REVIEWERS ARE GOING
UP, IF THE NUMBERS OF WOMEN
GETTING FUNDED ARE OR UNDER
REPRESENTED GROUPS GETTING
FUNDED IT'S A DISSERVICE SO
THAT'S AN IMPORTANT METRIC TO
TRACK AS WELL.
>> YEAH.
ONE OF THE THINGS WE DO IS PAY
ATTENTION TO THE EXTENT OF
REVIEW SERVICE THAT ANY GIVEN
REVIEWER HAS.
THIS I WILL SAY DOESN'T COME SO
MUCH FROM THE STANDPOINT OF
CONCERN ABOUT OVERLOADING
REVIEWERS BUT IT DOES HAVE THAT
EFFECT.
SO THE NUMBERS WE LOOKED AT
ABOUT OVER REPRESENTATION ARE
HAPPENING AT A POPULATION LEVEL.
WHEN YOU LOOK AT INDIVIDUAL
LEVELS, I THINK THE QUESTION IS
SORT OF ARE WOMEN AND OTHER
GROUPS BEING ASKED TO DO LOTS OF
SERVICE --
>> ARE THEY GETTING THE SAME
BANG FOR THEIR BUCK FOR THE
SERVICE THEY'RE PROVIDING?
>> THEY'RE NOTHING AT AN
INDIVIDUAL LEVEL THEY'RE NOT
BEING ASKED TO DO MORE SERVICE.
ACTUALLY, WE MONITOR THIS AND
WANT TO MAKE SURE PEOPLE DON'T
SERVE EXCESSIVELY.
SO IT'S DEFINITELY A CONCERN AND
HARD TO MONITOR AT AN AGENCY
LEVEL.
THESE ARE INDIVIDUAL DECISIONS.
THEY'RE VOLUNTARY AND WE DO
WE'LL HEAR FROM PEOPLE
OVERLOADED.
THAT HAPPENS.
>> THERE ARE HUGE BENEFITS TO
REVIEW YOU'RE A BETTER GRANT
WRITER BUT IS IT TOO MUCH AND
DISPROPORTIONATELY AFFECT THEM
TO GET LESS FUNDING SO TRACKING
THE DELTA BETWEEN FUNDED AND
REVIEW AND MAKING SURE THAT'S
EVEN ACROSS GROUPS MIGHT BE AN
EASY WAY TO DO IT AND IF IT
SEEMS TO BE THAT DELTA IS
GROWING THEN IT'S SOMETHING WE
NEED TO THINK ABOUT.
OKAY.
I'LL BE QUIET.
SORRY.
>> DOES THAT ROUGHLY COVER YOUR
POINT?
>> I THINK THAT MOSTLY COVERS
BUT I WAS ASKED [INDISCERNIBLE]
>> THE MORE SERVICE TIME WOMEN
ARE PUTTING INTO THE RELIEF AND
LOOKING TO CLOSE THE DELTA WE
WERE TALKING ABOUT.
>> OKAY.
WHAT WE'RE GOING TO DO IS WE'RE
GOING TO DO -- BECAUSE I WANT TO
HEAR THE ANSWER MYSELF, AND THEN
WE'LL MOVE TO THE HANDS IN THE
CHAT.
SO JUST THE REMOVAL OF THE
BUDGET ASPECT OF THE REVIEW, ARE
THERE GOING TO BE ANY ELEMENT OF
THAT OR IS THE BUDGET NOT
BROUGHT UP AT ALL?
>> SO, REVIEW OF RPGs.
UNDER THE SIMPLIFIED REVIEW
PRINT, THE BUDGET WILL BE
REVIEW.
IT HAS TO BE REVIEWED BY ALL.
SO THAT IS THERE AND WE'LL ASK
REVIEWERS TO COMMENT ON IT.
IF THERE WERE CONSENSUS IT WOULD
MAKE THE ADMIN NOTE THAT SHOULD
BE NOT REMOVED OR WHAT NOT.
OKAY.
GREAT.
TIM.
>> THANK YOU.
I'D LIKE TO HEAR THE CLARITY AND
PROGRESS OF CSR.
TWO QUESTIONS.
ONE WAS SIMPLE, WHAT FRACTION OF
PEOPLE THAT YOU APPROACH FOR
STUDY SECTION ROLES UNDER AD HOC
ACTUALLY SAY NO?
WHEN I WAS DOING IT MORE OFTEN,
I HAD A LOT OF PEOPLE THAT
DIDN'T WANT TO DO IT AND WERE
GOOD SCIENTISTS AND I FELT IT
WAS UNACCEPTABLE AND CITIZENSHIP
AND DON'T KNOW IF THAT'S A TREND
THAT EXISTS TODAY.
>> A LOT OF PEOPLE SAY NO.
CERTAINLY FOR ANY GIVEN MEET
MEETING -- THERE'S NO
CENTRALIZED INVITATION PORTAL TO
TRACK WHO IS GETTING INVITED AND
WHAT THE RESPONSE IS.
BUT THE NUMBERS GET TO BE PRETTY
HIGH.
IT'S SOME MULTIPLE OF IN TER --
INTERGER AND --
>> I WONDERED IF THERE WAS A
MECHANISM THAT SOMEHOW
ENCOURAGES PEOPLE TO DO IT.
HOUND PEOPLE FOR NOT DOING IT?
>> SO, WE HAVE AN ADVISORY
COUNCIL WORKING GROUP WORKING ON
THIS RIGHT NOW , HOW TO
INCENTIVIZE REVIEW.
WE GET SUGGESTIONS TO MAKE IT
MANDATORY WHICH I WOULD LIKE NOT
TO DO.
YOU CAN MAKE PEOPLE DO IT BUT
CAN'T MAKE THEM DO IT WELL AND
WE HAVE A WORKING GROUP LOOKING
AT EXACTLY THAT PROBLEM.
>> AND MAYBE THERE WAS BAD
COFFEE.
THERE WAS A QUESTION TO THE
REVIEW SYSTEM AND DON'T KNOW IF
IT'S UNDER CRS BUT OUTCOME.
I SAY THIS CONSIDERING I HAVE A
DECENT TRAINING RECORD AND
DISMAL FOR GETTING PEOPLE
GETTING F GRANTS WHILE UP MY
LAB.
I THINK I'M NOT WRITING THEM AND
NEVER KNEW QUITE WHAT THE HIT
WAS BUT THEY'RE ALL DOING FINE
IS THERE A PROCESS TO SEE WHAT
HAPPENS TO WHETHER YOU GOT THE
GRANT OR REJECTED AND WHAT ENDED
UP HAPPENING?
>> IT'S NOT WITHIN CSR'S SCOPE.
IT'S AN IMPORTANT QUESTION.
AND SOMETHING COULD BE LOOKED
AT.
TIM, I DO BELIEVE OUR TRAINING
OFFICE DOES ACTUALLY TRACK.
SAMEER.
>> THANKS.
REGARDING THE RP G I'M TRYING T
THINK OF THE IMPLICATIONS OF NEW
SCORING SYSTEM AND MY GUESS AND
YOU PROBABLY ALREADY MODELLED
THIS ARE AVERAGE SCORES GO UP
AND I THINK A LOT OF TIMES
INVESTIGATOR AND ENVIRONMENT
TEND TO BE BETTER SCORES AND IF
THAT'S NOT SCORED THE APPROACH
BECOMES HIGHER INFLUENCE.
SO, ON ONE HAND PERCENTILE MAY
NOT CHANGE AT ALL AND I ASSUME
THIS WOULDN'T APPLY TO ANY
NON-PERCENTILED GRANTS.
>> RIGHT.
>> OKAY, FINE.
THEN WE HAVE THIS COMPARISON OF
WHAT IS THE EQUIVALENCE FACTOR
FOR OTHER NON-PERCENTILE GRANTS
AND THAT WOULD CHANGE IF SCORES
IN GENERAL CHANGE.
IS THERE A LEVEL SETTING THAT
WILL HAVE TO OCCUR WITH THE
CHANGE IF THERE'S A SYSTEMIC
DRIFT OF THE AVERAGE SCORE
UPWARDS WORSENING DIRECTION?
>> YEAH.
WE DON'T KNOW.
I'M NOT SURE WE WILL SEE A SHIFT
FOR A COUPLE OF REASONS.
RIGHT KNOW REVIEWERS DON'T
AVERAGE THEIR CRITERION SCORES.
SO YOU'RE RIGHT THE
INVESTIGATORS TEND TO BE SCORED
PRETTY HIGHLY BUT THEY'RE NOT
JUST AVERAGED.
HOW MUCH THEY DRIVE THAT SCORE
PROBABLY VARIES.
THE OTHER THING IS STUDY
SECTIONS SORT OF OPERATE AT
THEIR OWN UNITS.
YOU HAVE YOUR YOU HAVE YOUR OWN
STANDARDS AND I KIND OF THINK
THE STUDY SECTION WILL NOT SHIFT
EVERYTHING NEGATIVELY.
IT IS SOMETHING WE HAVE TO
WATCH.
WE WILL KEEP A CLOSE EYE ON IT
IF WE NEED TO RESET THE
PERCENTILE BASIS WE CAN.
IF THERE SEEMS TO BE A GENERAL
SHIFT, WE GET A LOT OF SCORE
DATA IN A HURRY.
SO WE COULD ISSUE SOME SORT OF
MAPPING ALGORITHM OR SOME SORT
OF -- WE COULD HAVE INFORMATION
TO HELP PEOPLE MAKE COMPARISONS
IF YOU HAD TO DO THAT FOR SOME
REASON AND WHAT THE NEW SYSTEM
WAS IN EFFECT.
BOB.
>> FIRST OF ALL, THERE REED THAT
WAS A GREAT PRESENTATION.
FOR MOST OF US CSRs IT'S BEEN A
SOURCE OF GREAT MYSTERY AND YOU
ELUCIDATED THAT AND WE
APPRECIATE THAT AND APPRECIATE
THE CHANGES YOU DESCRIBED.
I HAVE TWO OR THREE GRANULAR
QUESTIONS.
ONE KEN TOUCHED ON IS ABOUT 25%
OF THE APPLICATIONS THAT COME
INTO THE NIH DO NOT GO TO THE
CSR.
SO ONE OF THIS QUESTIONS BASED
ON YOUR FIRST POWER POINT.
WHERE DO THEY GO?
>> THEY GO TO THE INSTITUTES.
SO NINDS REVIEWS A LOT OF -- I
DON'T KNOW QUITE HOW MANY OFF
THE TOP OF MY HEAD BUT EVERY
INSTITUTE HAS IT'S OWN REVIEW
SHOP.
>> WHAT DISTINGUISHES OR
DETERMINES ONE PAN WAY FOR
REVIEW -- PATHWAY FOR REVIEW
VERSUS ANOTHER?
>> TYPICALLY MORE COMPLEX
MECHANISMS, CENTER GRANTS,
PROGRAM PROJECTS, RFAs THAT THE
INSTITUTE IS OBVIOUSLY HIGHLY
INVESTED IN THOSE TEND TO COME
TO THE INSTITUTE.
SOME INSTITUTES LIKE TO DO THEIR
OWN Ks FOR EXAMPLE AND THERE'S A
FEW THAT DO THEIR OWN Fs.
SO AGAIN THE PERSPECTIVE IS THEY
HAVE ESPECIALLY STRONG STATE FOR
EXAMPLE IN TRAINEES THAT GETS
DIVVIED UP.
>> THANK YOU.
ANOTHER ISSUE THAT COMES UP AS A
SOURCE OF FRUSTRATION IS THE
ISSUE OF APPLICANT-DRIVEN PANEL
SELECTION.
AFTER WE WRITE GRANTS WE OFTEN
SPEND TIME REVIEWING PANELS
LOOKING AT ALL THE MEMBERSHIP OF
THE PANELS AND TRYING TO SELECT
THE ABSOLUTE BEST FOR OUR
PROPOSAL.
AND THEN VERY OFTEN THAT IS NOT
IN FACT WHERE THE GRANTS GETS
ASSIGNED.
CAN YOU COMMENT ON HOW YOU
ATTEMPT AT LEAST TO ACCOMMODATE
THE APPLICANT'S PREFERENCES?
>> YEAH.
SO OUR POLICY AND PROCEDURE IS
TO TRY TO CERTAINLY CONSIDER
WHAT THE APPLICANTS DESIRE.
THEN THE QUESTION SO WHAT WE ASK
OUR CHIEFS TO DO IS TO SEE
WHETHER THE PANEL THAT THE
APPLICANT SEEKS IS A GOOD FIT
AND THAT THE THE CRITERION WE
USE.
WE DON'T SAY IT HAS TO BE THE
BEST FIT.
WE SAY IF IT'S A GOOD FIT TAKE
IT.
WE DO GET DIFFERENCES IN OPINION
OWN WHAT THE BEST OUGHT TO BE
AND THERE'S APPLICANT'S PART ON
WHAT THE FOCUS OF A STUDY
SECTION IS.
IT ALWAYS OUGHT TO BE EXPLAINED
SCIENTIFICALLY.
THAT'S THE BASIS OF WHAT WE'RE
TRYING TO DO.
WE ARE TRYING TO ASSIGN THE
APPLICATION TO THE STUDY SECTION
THAT FITS BEST WITHIN THE
GUIDELINES.
THEY SAY TAKING INTO ACCOUNT
APPLICANT PREFERENCES AND
HONORING THOSE WHEN IT'S A
REASONABLE FIT.
>> AS LONG AS YOU'RE LOOKING AT
IT.
WE ARE LOOKING AT IT ALWAYS.
>> OKAY.
JIM.
>> SO I WANTED TO GO BACK TO A
QUESTION THAT TIM ASKED ABOUT
WHO SAYS NO FOR STUDY SECTION
REVIEW BECAUSE I THINK THAT
MIGHT BE IMPORTANT FOR
UNDERSTANDING THE DISCREPANCY
BETWEEN MALE AND FEMALE
REVIEWERS.
I WONDER IF THERE'S MORE MALE
REVIEWERS FOR REFUSING AND MORE
SENIOR IN THEIR CAREERS AND THAT
MAY BE DRIVING THE DIFFERENCE
BECAUSE THIS GOES BACK TO THE
CITIZENSHIP.
I THINK IT'S IMPORTANT FOR THOSE
WHO BENEFIT FROM NIH SUPPORT
THEY ALSO PARTICIPATE IN IT
REVIEW.
>> I DON'T THINK I HAVE DATA TO
ANSWER THAT QUESTION.
I JUST DON'T KNOW.
IF YOU LOOK BACK IT DOESN'T HAVE
TO BE THAT LONG.
BUT IF YOU LOOK BACK THE
COMPOSITION OF STUDY SECTIONS
WAS MUCH MORE HEAVILY MALE AND
SENIOR WHITE MALE INVESTIGATORS.
THEY WERE OVER REPRESENTED AND
THAT HAS CHANGED.
AS WE'VE DESCRIBED WE DID A LOT
OF THINGS TO TRY TO DRIVE THOSE
CHANGES.
AS FAR AS I'M AWARE, I'M NOT
AWARE OF CHANGES IN POTENTIAL
REVIEWER BEHAVIOR THAT WOULD
ACCOUNT FOR THAT.
I THINK PEOPLE SAY NO FOR A
LARGE VARIETY OF REASONS.
SOME IS IT'S SIGNIFICANT WORK.
NO DOUBT ABOUT IT.
I SIGH PEOPLE WHO HAVE A LONG
STRAIN OF NIH AWARDS WHO HAVE
NOT SERVED.
THAT DOESN'T SEEM RIGHT.
THEY HAVE THE KNOWLEDGE AND
CAPABILITY.
THEY OUGHT TO BE SERVED.
YOU DO SEE SOME.
YOU SEE PEOPLE AT A VARIETY OF
CAREER STAGES.
I WILL SAY WE HAVE TAKEN A
NUMBER OF STEPS TO TRY TO MAKE
PARTICIPATION EASIER FOR A
DIVERSITY OF GROUPS.
FOR EXAMPLE, RIGHT NOW WE RUN
ONE MEETING A YEAR, ONE OF THE
STANDING STUDY SECTION MEETINGS
A YEAR IN PERSON.
THE OTHERS ARE RUN VIRTUALLY OR
MOVING TOWARDS AN INCREASED USE
OF HYBRID.
ONE ADVANTAGE IS PEOPLE WHO HAVE
OTHER RESPONSIBILITIES, HOME
CHILDCARE, CAREGIVING OR MAYBE
HAVE CLINICAL RESPONSIBILITIES
AND TWO EXTRA DAYS OF FLYING
MAKE IT ATTAINABLE TO COME IN
VISITLY.
WE'RE WORKING TO MAKE THOSE
MEETINGS GOOD MEETINGS SO THAT'S
AN ONGOING FUNCTION FOR PEOPLE
TO PARTICIPATE.
>> I WOULD ADD THOUGH IT'S A
SMALL NUMBER SERVING AS CRITICAL
CRITERIA TO GET A MERIT AWARD UP
THIS INSTITUTE.
OKAY.
ANY OTHER QUESTIONS FOR BRUCE?
>> I HAVE A QUESTION ABOUT THE
FELLOWSHIPS.
SO THERE'S GOOD EVIDENCE THAT
THE KEY INGREDIENT IN BECOMING A
SUCCESSFUL INVESTIGATOR IS THE
MENTORSHIP THAT IS OFFERED BY
THE PERSON, THE FELLOW WORKING
WITH.
SO HOW IS THAT DEALT WITH NOW IN
THE SYSTEM?
THE EVALUATION OF THE METRICS?
>> SO THE CHANGES REALLY DO TRY
TO ARE BRING A FOCUS ON THAT.
THE QUALITY OF THE MENTORSHIP.
IT DOES IT BY REQUIRING MENTORS
TO REALLY GIVE A SPECIFIC
ACCOUNT OF HOW TO THEY'RE TRYING
TO MENTOR THAT PARTICULAR
STUDENT.
SO STUDENTS HAVE CERTAIN GOALS
AND HOW AND HOW IS THAT MENTOR
GOING TO MEET THOSE?
SO IN THE PAST IT'S BEEN I'D SAY
A COMBINATION OF ONE IS WHAT THE
FUNDING LOOKS LIKE THAT
IMPRESSES PEOPLE AND THE OTHER
IS A LIST OF TRAINEES.
THE LIST OF TRAINEES IS NOT
ALTOGETHER IRRELEVANT.
IT DOESN'T SPEAK TO WHAT THEY'LL
BRING TO THAT STUDENT OR TO WHAT
JUNIOR PEOPLE CAN DO.
I'VE HAD CONVERSATIONS WITH A
LOT OF SENIOR INVESTIGATORS WHO
SAID THEIR BEST DAY WAS AS AN
ASSIST AND THE AND CARED AND HAD
THE TIME AND DID A GOOD JOB AND
FROM THEN ON IT WAS ALL DOWN
HILL.
I GOT DISTRACTED BY OTHER
CONCERNS.
THAT THE NOT EVERYBODY.
AND WE'RE ASKING PEOPLE TO BE
MORE SPECIFIC ON WHAT THEIR PLAN
AND APPROACH IS.
>> ONE OTHER QUESTION WE'VE ON
OCCASION WHEN WE LOOKED AT
FELLOWSHIP APPLICATION WORRY
ABOUT THE P.I. HAS NO GRANT BUT
THE IDEA THAT IT'S GOING TO BE A
TOUGH PLACE TO SUCCESS IF
THEY'RE ALREADY ON SHAKY GROUND.
YOU MENTIONED THAT IS NO LONGER
OR --
>> THE APPLICATION WILL BE SUCH
THE APPLICATION NEEDS TO SHOW
THEY HAVE THE MONEY TO DO WHAT
THEY PROPOSE.
IT DIDN'T MATTER --
>> IF THE FELLOWSHIP DOESN'T
HAVE THE MONEY -- THERE'S NO
MONEY IN THESE THINGS.
IT DOESN'T SUPPORT --
>> THE P.I. HAS TO SHOW.
>> THE P.I. OR THE UNIVERSITY
HAS TO SAY HERE'S WHERE WE GOT
THE MONEY TO SUPPORT THIS
PROJECT AND VARIOUS RESOURCES
THAT YOU'RE GOING TO AVAIL
YOURSELF OF AND SHOW US HOW
THAT'S GOING TO WORK.
>> IF THERE'S NO OTHER QUESTIONS
FOR BRUCE, THANK YOU.
>> THANK YOU.
>> WE REALLY APPRECIATE IT AND
GIVE OUR BEST TO NONI.
HOPE SHE GETS BETTER SOON.
>> SO BEFORE WE BREAK FOR LUX
LUNCH I WANT TO ADD ABOUT
OUTCOMES AND THE NEIGHBOR CAN
FILL YOU IN ABOUT TRACK AND
LOOKING INTO OUTCOMES OF VARIOUS
APPROACHES.
TIM, I'LL HAND IT TO YOU TO
INSTRUCT US.
>> WE'LL RECONVENE AT 1:30.
THERE ARE PLENTY OF PLACES RIGHT
NEAR YOUR HOTEL TO GET SOMETHING
TO EAT.
IF YOU NEED RECOMMENDATIONS,
SHERYL CAN TELL YOU.
SHE HAS FINER TASTE THAN MYSELF.
AND RECONVENE AT 1:30.
BEAUTIFUL. THANK YOU VERY MUCH
>> THE REPORT WAS THAT NIH
INITIATE A STRATEGIC PLANNING
PROCESS FOR RESEARCH ON ME/CFS
AND WE PLANNED A REPORT AND GOT
SIDE LINED BY THE PANDEMIC AND
PHYSICIANS WERE OVERWHELMED
SEEING PATIENTS AND
INVESTIGATORS WERE TRYING TO
FIGURE OUT HOW TO KEEP THEIR
LABS GOING WHEN LABS WERE
CLOSED.
SO WE PAUSED THE WHOLE PROCESS
AND THEN RESTARTED THE PROCESS
AGAIN IN THE FALL OF 2022 AND
LAUNCHED THE PROCESS OF
DEVELOPING THE ROAD MAP IN
FEBRUARY OF 2023.
THE CHARGE OF COUNCIL WAS TO
PROVIDE GUIDANCE TO THE NINDS
COUNCIL ON HOW THIS WORKED FOR
THE DEVELOPMENT OF TREATMENTS.
SO THIS IS A LIST OF ALL THE
INDIVIDUALS WHO PARTICIPATED ON
THE WORKING GROUP OF COUNCIL.
IT INCLUDED THE TWO CO-CHAIRS
AND MEMBERS AND LEADERS OF THE
PATIENT ADVOCACY GROUPS IN THIS
SPACE.
IT ALSO INCLUDED CLINICIAN
SCIENCE AND INVESTIGATORS AND
INCLUDED INDIVIDUALS PEOPLE WITH
LIVED EXPERIENCE.
ALSO INDEPENDENT TOGETHER WITH
THE WORKING GROUP OF COUNCIL
INVOLVED AN ADDITIONAL 21
INDIVIDUALS WHO WERE PEOPLE WITH
LIVED EXPERIENCE SO THESE WERE
INDIVIDUALS WHO EITHER
THEMSELVES HAVE ME/CFS OR
PARTNERS TO A SPOUSE WHO HAS
ME/CFS OR CHILDREN WITH THE
DISEASE.
IT'S A KEY PART OF THE WHOLE
PROCESS TO INVOLVE THESE
INDIVIDUALS WITH PEOPLE WITH
LIVED EXPERIENCE WHO BROUGHT SO
MUCH OF THEIR PERSPECTIVE TO ALL
OF THE DISCUSSIONS THROUGHOUT
THE PROCESS.
WHAT WE DID WAS TO LOOK AT THE
DIFFERENT DOMAINS AND ORGANIZED
OUR PROCESS BY DEVELOPING THE
EIGHT AREAS AND EIGHT WORKING
GROUPS AROUND CHRONIC INFECTION,
IMMUNE SYSTEM AND CIRCULATION
AND LESS KNOWN PHYSIOLOGY AND
GENETICS AND HEAR MORE ABOUT
ME/CFS SPECIFICALLY WHEN CINDY
STARTS TO TALK AND YOU'LL I
THINK GET FROM THIS, GET THE
IMPRESSION AND THE IDEA THAT
ME/CFS IMPACTS ALMOST EVERY
SYSTEM OF THE BODY.
SO IT'S REALLY LIKE DOING EIGHT
DIFFERENT STRATEGIC PLANS.
BUT WE ORGANIZE THIS INTO
WEBINAR PLANNING GROUP.
EACH GROUP ORGANIZED A FULL DAY
WEBINAR WHERE WE COULD REALLY
EXAMINE WHAT WE KNOW, WHAT WE
DON'T KNOW AND WHAT WE NEED TO
KNOW TO MOVE TOWARDS CLINICAL
TRIALS IN THIS SPACE.
THIS IS OUR TIME LINE.
WE STARTED THE WHOLE PROCESS IN
FEBRUARY OF 2024.
OR 2023, SORRY.
WE HELD EIGHT WEBINARS BETWEEN
AUGUST AND JANUARY 2023 AND 2024
AND EACH OF THOSE GROUPS
DEVELOPED RESEARCH PRIORITIES
FOR THEIR DOMAIN.
THOSE RESEARCH PRIORITIES WERE
PUT ON A CROWD SOURCING PLATFORM
AND WE GOT EXCELLENT FEEDBACK
FROM THE FUNT ACROSS ALL THE
RESEARCH FROM THE COMMUNITY
ACROSS ALL ALL RESEARCH AND THE
REPORT WAS DONE IN MARCH AND
APRIL AND WE'RE HERE IN MAY
PRESENTING THE FINAL REPORT FOR
YOUR REVIEW AND ACCEPTANCE.
IT'S TIME FOR ME TO NOW TURN IT
OVER TO DR. CINDY BATEMAN WHO IS
GOING TO START NOW WITH HER
COMMENTS FROM AN ME/CFS
CLINICIAN AND WAS ONE OF THE
COCHAIRS OF THE PROCESS.
THANK YOU, TAKE IT AWAY, CINDY.
>> THANK YOU, VICKY.
IT'S A PLEASURE TO BE HERE.
IT WAS A PLEASURE TO WORK WITH
THIS GROUP --
>> WE CAN'T HEAR YOU, CINDY.
>> IT'S VERY LOW VOLUME.
>> CAN YOU YOU HEAR ME NOW?
>> HOLD ON A SECOND.
>> WE'RE GETTING THE TECHNICAL
PEOPLE.
>> YOU'RE FINE.
I WONDER IF IT'S SOMETHING IN
THE ROOM.
>> I CAN HEAR YOU REALLY WELL,
MARI.
>> I CAN HEAR CINDY REALLY WELL.
>> SHE'S LOW TOO.
REALLY LOW.
IT APPEARS EVERYONE ONLINE CAN
HEAR FINE IT'S JUST IN THE ROOM.
>> THAT'S CORRECT.
>> IF I TALK LOUDER IT MAY BE
TOO LOUD FOR THE PEOPLE ONLINE.
>> CAN YOU HEAR ME NOW?
>> WE CAN HEAR YOU.
>> HOW DOES IT SOUND IN THE
ROOM?
>> WE HAVE SOMEONE IN THE ROOM.
>> GIVE IT A TRY.
>> CAN YOU HEAR ME NOW?
IS THAT BETTER THAN IT WAS?
>> NO, CAN'T HEAR.
>> YOUR SPEAKERS ARE A PROBLEM.
>> HOW DOES IT SOUND NOW?
>> MUCH BETTER.
>> OKAY.
GOOD.
SHALL I GO AHEAD?
ALL RIGHT.
I'M CINDY BATEMAN.
I'M AN ME/CFS CLINICIAN.
IT'S AN GREAT HONOR TO BE HERE
REPRESENTING OUR ME/CFS
STAKEHOLDERS AND IT WAS A
PLEASURE TO WORK WITH THIS
GROUP.
REALLY INTERESTING AND FUN.
I JUST WANT TO GIVE YOU A LITTLE
CLINICAL CONTEXT.
BEFORE THE PANDEMIC ME/CFS WAS
EXPECTED TO AFFECT 3 MILLION
PEOPLE IN THE U.S. AND THIS MAY
BE AN UNDER ESTIMATE.
SO WHY IS THIS IMPORTANT?
THIS IS SPECIFICALLY FROM A
LITTLE BIT OF MY OWN PERSPECTIVE
AND THOSE OF US IN THE
STAKEHOLDER PUBLIC.
YES, WE WERE SUPPOSED TO OBSERVE
ASSESS CURRENT RESEARCH
ACTIVITIES AND IDENTIFY
OPPORTUNITIES AND GAPS IN ME/CFS
RESEARCH TO IDENTIFY TARGETS FOR
DEVELOPMENTS AND TREATMENTS VIA
THE NINDS COUNCIL TO NIH BUT
GAVE US AN OPPORTUNITY TO UPDATE
RESEARCH KNOWLEDGE SINCE THE
PUBLICATION OF THE IOM INSTITUTE
OF MEDICINE REVIEW PUBLISHED IN
2015 A CHANCE TO FOCUS
SPECIFICALLY ON ME/CFS THAT'S
BEEN DROWNED OUT BY THE PANDEMIC
AND LONG COVID WHILE STILL
RECOGNIZING WE CAN GAIN NEW
KNOWLEDGE BY UNDERSTANDING LONG
COVID AND HOW IT RELATES TO
ME/CFS.
IT WAS AN INTERESTING FORUM TO
BE CROSS-DISCIPLINARY AND BE
ABLE TO CONSIDER THE OVERLAP AND
THE MANY DIMENSIONS OF THIS
DISEASE INSTEAD OF STAYING IN
OUR SPECIALTY SILOS.
THAT'S PARTICULARLY DIFFICULT
BUT IMPORTANT WITH THIS
MULTI-SYSTEM DISEASE.
AND IT GIVES US A CHANCE TO
IMMORTALIZE THIS COMBINED
EXPERTISE AND MAKE IT WIDELY
AVAILABLE BY MAKING IT AVAILABLE
TO ANYBODY WHO WOULD LIKE TO SEE
IT AND REVIEW IT.
SO, YOU DON'T HAVE TO READ ALL
THIS BUT HERE ARE THE EIGHT
WEBINAR TOPICS AND LISTED THE
SUB TOPICS UNDERNEATH TO GET AN
IDEA OF THE RANGE.
I ALSO WANT YOU TO NOTE THAT
EACH OF THE WEBINAR SUB TOPICS
HAS MULTISYSTEM PRESENTATION.
THIS CREATES A VERY CHALLENGING
TARGET FOR BOTH CLINICAL AND
RESEARCH MANAGEMENT.
AND THIS I OVERLAID IN RED INK
BECAUSE I THINK THESE ARE THE
AREAS PARTICULARLY AMPLIFIED OR
BRAND NEW SINCE THE INSTITUTE OF
MEDICINE OF REPORT WAS PUBLISHED
IN 2015.
YOU CAN SEE A HUGE AMOUNT OF
INCREASE IN OUR UNDERSTANDING OF
THE BREADTH AND DEPTH OF THE
ILLNESS.
JUST TO KIND OF INTRODUCE YOU TO
ME/CFS WHICH YOU MAY OR MAY NOT
HAVE MUCH CLINICAL OR PERSONAL
EXPERIENCE WITH.
OF COURSE IT'S CHRONIC FATIGUE
SYNDROME, ENCEPHALOMYELITIS AND
IT INVOLVES THE BRAIN,
PERIPHERAL NERVOUS SYSTEM AND
CIRCULATORY SYSTEM AND IMPAIRED
METABOLISM AT LEAST AND I'VE
LISTED SOME OF THE EVIDENCE THAT
WE HAVE SO FAR BACKING THIS UP.
AND WHILE IT'S MOST FREQUENTLY
CONSIDERED POST VIRAL OR POST
INFECTIOUS, THERE'S EVIDENCE OF
IMMUNE TRIGGERS AND
ENVIRONMENTAL FACTORS, TRAUMA
AND OTHER THINGS ASSOCIATED WITH
THE ONSET OF ME/CFS BUT AS WE
WOULD BOTH SAY IT DOESN'T RULE
OUT VIRAL INVOLVEMENT IN THIS
PROFESSION.
-- PROCESS.
IN ME/CFS THE DIAGNOSIS IS
TYPICALLY MADE VERY LATE MAYBE
YEARS INTO THEIR ILLNESS.
IT'S NOT UNCOMMON FOR PEOPLE TO
GO FIVE, SIX YEARS BEFORE THEY
GET A DIAGNOSIS AND THERE'S ALSO
EVIDENCE TO SUGGEST AS THE
HIGHLY UNDER DIAGNOSED AND
UNRECOGNIZED IN CLINICAL
MEDICINE.
SO WE REALLY HAVE NOT HAD A GOOD
LOOK AT THE EARLY NATURAL
HISTORY.
AND WHAT'S REALLY INTERESTING
ABOUT THE LONG COVID PANDEMIC,
THE COVID PANDEMIC IS THAT THE
THEORIES EMERGING ABOUT LONG
COVID REALLY PARALLEL THE
THEORIES WE HAVE THAT MIGHT
EXPLAIN WHAT'S GOING ON IN
ME/CFS.
AND DEEPER INSIGHTS ARE EMERGING
INVOLVING THE ROLE OF RISK
FACTORS AND OTHER OVERLAPPING
RELATED CONDITIONS YOU'LL HEAR
MORE ABOUT IN THE REPORT.
THESE ARE THE NATIONAL ACADEMY
OF MEDICINE 2015 INSTITUTE OF
MEDICINE ME/CFS CLINICAL
DIAGNOSTIC CRITERIA.
THAT REVIEW WAS NOT REALLY A
RESEARCH REVIEW.
IT WAS AN EVIDENCE BASED REVIEW
TO DETERMINE DIAGNOSTIC CRITERIA
YA FROM THE REPORT AND THERE'S
IMPAIRED FUNCTION AND IT USED TO
BE FATIGUE WAS THE FIRST LISTED
BUT IT GOT DEMOTED TO FURTHER IN
THE SENTENCE BECAUSE IT'S
IMPAIRED FUNCTION AND THEN POST
EXERTIONAL MALAISE AN ESCALATION
OF ILLNESS FROM TRYING TO EXCEED
TOLERABLE ACTIVITY AND
DYSREGULATED SLEEP PROBABLY
CENTRALLY AND AT LEAST ONE OF
THE FOLLOWING COGNITIVE OR
ORTHOSTATIC INTOLERANCE.
THAT CAME BECAUSE THE PEDIATRIC
LITERATURE WAS STRONGER IN OTHER
STATIC IN TOLERANCE AND THE
ADULT LITERATURE WAS STRONGER IN
COGNITIVE IMPAIRMENT BUT THEY'RE
IMPORTANT AND KEY FEATURES.
SO AS THE CRITERIA HAVE TO ALL
BE PRESENT IN MAD -- MODERATE TO
SEVERE FEATURES 70% OF THE TIME
THERE'S IMMUNE AND INFLAMMATORY
MANIFESTATIONS AND INTERMITTENT
INFECTION MANIFESTATIONS AS
WELL.
SO IT'S REALLY IMPORTANT FOR
PEOPLE TO UNDERSTAND THAT THIS
ILLNESS IS DISTINGUISHED FROM
OTHER ILLNESSES AND OTHER TYPES
OF CHRONIC FATIGUE BY THE AMOUNT
OF IMPAIRMENT AND DEBILITATION
PRESENT AND THE DEVELOPMENT OF
POST-EXERTIONAL MALAISE AND
THAT'S TRIGGERS BY STRESSORS AND
THEY COULD BE MINOR AND CAN BE
PHYSICAL, COGNITIVE, SENSORY,
EMOTIONAL OR ORTHOSTATIC
STRESSORS TO TRIGGER
POST-EXERTIONAL MALAISE AND THE
ILLNESS AND CAPACITY RANGES FROM
DIFFICULTY MAINTAINING A NORMAL
SCHEDULE EVEN IN PEOPLE MOSTLY
RECOVERED ESPECIALLY WHEN IT
COMES TO PHYSICAL ACTIVITY OR
TRYING TO DO MULTIPLE TASKS
DURING THE DAY TO PATIENTS KIND
OF LOST FROM SOCIETY BECAUSE
THEY'RE HOUSE BOUND OR BED
RIDDEN AND STUDIES HAVE SHOWN UP
TO 25% OF CASES CAN BE SEVERELY
ILL ON THE OTHER SIDE OF THAT
SPECTRUM AT SOME POINT IN THEIR
ILLNESS.
SOME PEOPLE GO BACK AND FORTH
BETWEEN THESE CONDITIONS BASED
ON FACTORS WE DON'T TOTALLY
UNDERSTAND AND SOME IS TRYING TO
EXCEED ACTIVITY CAPACITY.
THIS IS A PAPER -- THERE'S QUITE
A FEW PAPERS ON POST-EXERTIONAL
MALAISE AND THIS CAME FROM A
PATIENT STUDY MORE RECENTLY
PUBLISHED AND THEY DESCRIBED
POST-EXERTIONAL MALAISE.
THIS WAS CHARACTERIZED BY 43
PEOPLE WITH ME/CFS WHO WERE
PARTICIPATING IN FOCUS GROUPS
AND WENT ON TO INCLUDE THOSE IN
THE IN-PATIENT STUDY.
THIS IS A VISUAL PICTURE OF WHAT
IT LOOKS LIKE TO DEVELOP
POST-EXERTIONAL MALAISE.
IT'S NOT JUST FATIGUE I HEARD IT
DESCRIBED AS POISON.
ING -- POISONING.
I HEARD MANY TELL ME IT FEELS
LIKE THEY'RE DYING.
IT'S A TOTAL BODY SHUT DOWN WITH
ALL THESE FLAVORS AND CAN LAST A
FEW DAYS OR CAN LEAST WEEKS OR
MONTHS AND IN SOME CASES PEOPLE
STAY PERMANENTLY IN THAT
POSITION OF HAVING SEVERE
SYMPTOMS FROM REMEMBER FACTORS
WE DON'T ALL UNDERSTAND AND FROM
EXCEEDING THEIR ENERGY CAPACITY.
SO FROM THAT SAME PAPER I THINK
THIS IS POIGNANT.
THESE ARE ACTIVITIES THAT CAN
CAUSE POST-EXERTIONAL MALAISE.
THEY'RE DIVIDED INTO THREE
CATEGORIES BUT LOOK AT THE
SPECIFICS OF THE AMOUNT OF
EFFORT IT TOOK TO TRIGGER
POST-EXERTIONAL MALAISE.
READING A BOOK, SHOPPING, GOING
TO A DOCTOR'S APPOINTMENT,
PHYSICAL ACTIVITIES LIKE WALKING
OR SHOPPING OR GOING TO A
DOCTOR'S APPOINTMENT.
LOTS OF PEOPLE DON'T FEEL
COMFORTABLE DRIVING OR CAN ONLY
DO IT WHEN THEY'RE FEELING AT
THEIR BEST.
AND THEN THERE ARE SENSORY AND
EMOTION PRECIPITATED RELAPSES
THAT CAN OCCUR EVEN DEALING WITH
ANOTHER PERSON'S GRIEF AND
FEELINGS.
IT'S VERY DIFFICULT TO BE IN
GROUPS AND EVEN GOING OUT TO
DINNER IS KIND OF AN
OVERWHELMING SENSORY AND
PHYSICAL AND COGNITIVE EFFORT
THAT CAN SOMETIMES CREATE
POST-EXERTIONAL MALAISE IN
PATIENTS.
JUST TO COMMENT ABOUT
HETEROGENEITY BECAUSE I THINK IT
MADE IT DIFFICULT TO CARRY OUT
SMALL STUDIES AND TO KNOW HOW TO
INCLUDE PATIENTS IN RESEARCH.
AND NOT ONLY DOES THE
HETEROGENEITY COME FROM THE
MULTI-SYSTEM NATURE OF THIS
DISEASE BUT IT'S POSSIBLE ULLI
ILLNESS TRIGGERS THE SECONDARY
CONSEQUENCES.
FOR EXAMPLE, IF YOU START WITH A
VIRUS THAT TARGETS THE
GASTROINTESTINAL TRACT YOU MAY
HAVE RELAPSING MORE THAN SOMEONE
WHO GETS A RESPIRATORY OR
FLU-LIKE VIRUS.
IT COULD BE ALL ONE FAMILY OF
VIRUSES THAT TARGET OR HAVE
TROPISM FOR DIFFERENT SYSTEMS AS
WELL.
ALSO, STAGE AND DURATION OF
ILLNESS MAKE A BIG DIFFERENCE
AND NOT ONLY THAT BUT WHATEVER
STATE OF POST-EXERTIONAL MALAISE
YOU'RE IN, WHEN YOU GO TO
PARTICIPATE IN RESEARCH WILL
PROBABLY MAKE ME FINDINGS LOOK
DIFFERENT.
IF YOU'RE BACK TO BASELINE AND
RESTED YOU HAVE DIFFERENT
FINDINGS FROM SOMEONE IN RELAPSE
OR RECENTLY BEEN OVER DOING.
WE'RE LEARNING MORE ABOUT
COMORBID AND OVERLAPPING
CONDITIONS AND A LOT OF THOSE
ARE INCLUDED IN THE DISCUSSION
OF THE REPORT AND THEIR AGE,
SEX, ENVIRONMENTAL FACTORS AND
PROBABLY GENETIC FACTORS WE
DON'T UNDERSTAND VERY WELL BUT
ALL THESE AREAS NEED TO BE
ACCOUNTED FOR AS WE MOVE FORWARD
TO TRY TO UNDERSTAND THE
PATHOPHYSIOLOGY.
I'LL TURN THE TIME OVER TO
MAUREEN TO DISCUSS MORE OF THE
SCIENTIFIC MEAT OF THE REPORT.
>> THANKS.
I WANT TO VERIFY PEOPLE CAN HEAR
ME.
>> WE CAN.
>> THANKS.
SO, I WANT TO GIVE SOME OF THE
KEY POINTS REGARDING THE
RESEARCH PRIORITIES THAT WERE
DISCUSSED IN THE EIGHT DOMAINS
THAT VICKY ALREADY TOLD YOU
ABOUT.
BUT GIVEN THAT I HAVE TIME
LIMITATION I CAN'T GO INTO DEPTH
INTO ALL EIGHT OF THESE DOMAINS.
SO I'VE SELECTED THE FIRST THREE
HERE CHRONIC INFECTION, IMMUNE
SYSTEM AND NERVOUS SYSTEM.
THE LATTER BECAUSE I THINK MANY
ARE INTERESTED PARTICULARLY IN
THE NERVOUS SYSTEM BUT WILL
BRIEFLY TOUCH ON THE OTHER FIVE.
LET ME START WITH CHRONIC
INFECTION.
EMPHASIZE THE FACT THAT
THREE-QUARTERS OF THE
INDIVIDUALS WITH ME/CFS MENTION
THEY'RE ONSET FOLLOWED A
FLU-LIKE ILLNESS OR
MONONUCLEOSIS AND IT'S NOT KNOWN
BY A LOT OF PEOPLE FORTUNATELY
MANY OUTBREAKS HAVE OCCURRED
MANY TIMES IN THE LAST 100 YEARS
RECENTLY DURING THE MID-80s
THERE WERE A LARGE NUMBER OF
OUTBREAKS.
THE EVIDENCE FOR THE OUTBREAKS
IN THE MID '80s THEY WERE LIKELY
VIRAL IN NATURE BUT FOR THE MOST
PART MOST OF THOSE OUTBREAKS THE
VIRUS IS NOT IDENTIFIED BUT IN A
FEW OF THE OUTBREAKS THERE'S
GOOD EVIDENCE FOR ENTEROVIRUS AS
THE PATHOGEN AND IT'S POSSIBLE
ENTEROVIRUS FAMILY MEMBER WAS
THE PATHOGEN IN ALL THE MID '80s
OUTBREAKS AND LIKELY THE ONES IN
THE EARLIER YEARS.
SO THE QUESTIONS THAT REMAIN THE
WEBINAR EXPLORED AND THE
COMMITTEE CAME UP WITH IS WHICH
VIRUSES CAN INSIGHT ME/CFS
OUTBREAKS AS WELL AS THE
SPORADIC CASES LARGELY THE ONES
OCCURRING SINCE THE MID '80s AND
STILL OCCURRING TODAY.
AND WHAT IS THE ROLE OF EVB.
CAN IT INSIGHT OR REACTIVATE AND
MAINTAIN THE ILLNESS OR IS IT
ONLY A SUSCEPTIBILITY FACTOR?
THE ACTIVITY OF ENDOGENOUS
RETROVIRUSES ARE LITTLE
INVESTIGATED AND KEY QUESTION IN
CHRONIC INFECTION ARE THE
INCITING VIRUSES OR DERIVATIVES
STILL PRESENT IN SOME PROFESSION
-- ME/CFS CASES.
NEXT I'D LIKE TO DISCUSS THE
IMMUNE SYSTEM.
I'D LIKE TO DESCRIBE THE
ABUNDANT EVIDENCE OF IMMUNE
FUNCTION IN ME/CFS AND THERE'S
LARGE LITERATURE ABOUT THE
IMMUNE SYSTEM IN ME/CFS.
THE QUESTIONS THE COMMITTEE CAME
UP WITH IS AUTO IMMUNITY A KEY
FACTOR IN SOME OR ALL THE ME/CFS
CASES?
IS A PERSISTENT ANTIGEN CAUSING
IMMUNE CELL EXHAUSTION?
THE EXISTENCE OF A PERSISTENT
ANTIGEN WAS HYPOTHESIZED BY
THOSE IN THE INTERIM STUDY AND
WE AND OTHERS HAVE EVIDENCE FOR
IMMUNE CELL EXHAUSTION AS WELL.
THAT CAN BE CAUSED BY CHRONIC
VIRAL INFECTION.
WHICH SIGNALLING PATHWAYS ARE
DISRUPTED IN IMMUNE SYSTEM AND
WHAT IS THE ROLE OF LESS STUDIED
IMMUNE CELL TYPE SUCH AS GRANULE
SITES OR PLATELETS?
MOST HAVE BEEN STUDYING PLASMA,
SERUM, PBMCs AND THE OTHER TYPES
OF IMMUNE CELLS HAVE NOT HAD
ADEQUATE STUDY.
WE ALSO DON'T KNOW IF IMMUNE
CELLS FUNCTION ABNORMALLY IN THE
BLOOD BUT ARE THEY ABNORMAL IN
THE TISSUES AND ORGANS?
WHERE IN FACT IS THE
INFLAMMATION OCCURRING IN THE
BODY THAT COULD BE RESULTING IN
THE SYSTEMS AND WHO IS THE
NATURE OF THE GUT MICROBIOME
INTERPLAY AND WE HAVE EVIDENCE
THE GUT MICROBIOME IS DISTURBED
IN ME/CFS BUT DON'T KNOW IF IT'S
MERELY
SO WITH REGARD TO THE NERVOUS
SYSTEM, AMONG THOSE IOM
DIAGNOSTIC CRITERIA FOR ME/CFS
THAT CINDY MENTIONED ARE
UNREFRESHING SLEEP, COGNITIVE
IMPAIRMENT, AND ORTHO STATIC
INTOLERANCE, CONNECTED TO THE
NERVOUS SYSTEM.
THERE IS EVIDENCE FOR
NEUROINFLAMMATION IN THE
DISEASE, AS WELL AS REDUCED
CEREBRAL BLOOD FLOW, SMALL FIBER
NEUROPATHY HAS BEEN DOCUMENTED
IN A SMALL NUMBER OF CASES, A
SNAPSHOT OF WHAT WE ALREADY HAVE
ON THE NERVOUS SYSTEM.
WHAT THE COMMITTEE FOUND NEEDS
TO BE DONE IN THE FUTURE IS TO
IMPROVE THE TOOLS FOR ACCESSING
COGNITION IN ME/CFS, IT'S ONE OF
THE MAJOR COMPLAINTS OF
INDIVIDUALS WITH ME/CFS, THAT
THEIR BRAIN DOESN'T SEEM TO BE
WORKING, THEY CAN'T THINK AS
WELL AS THEY COULD BEFORE THEY
BECAME ILL.
IT WAS DECIDED BY THE COMMITTEE
TO RECOMMEND THE INVESTIGATION
OF THE ROLE OF CIRCULATORY
DYSFUNCTION IN NEURAL SYMPTOMS,
AND TO EXAMINE CEREBROSPINAL
FLUID FROM INFLAMMATORY AND
OTHER ABNORMALITIES, BECAUSE OF
THE GREATER DIFFICULTY OF
ACQUIRING CEREBROSPINAL FLUID
IT'S NOT BEEN EXAMINED AS MUCH
AS SHOULD BE, IT'S EASIER TO GET
BLOOD, SALIVA AND URINE, BUT IT
WAS RECOMMENDED WE NEED TO BE
EXAMINING CEREBROSPINAL FLUID.
IT'S ALSO IMPORTANT TO DETERMINE
WHAT DRIVES ORTHOSTATIC
INTOLERANCE, A QUITE DISABLING
SYMPTOM THAT RESULTS IN SOME
PEOPLE HAVING TO BE PRONE ALMOST
THE ENTIRE DAY BECAUSE THEY ARE
UNABLE TO REMAIN IN AN UPRIGHT
POSITION.
IT WAS ALSO RECOMMENDED TO USE
THE LATEST NEUROIMAGING
TECHNOLOGY TO UNCOVER BE ON
NORMALITIES AS WELL AS EFFECT OF
TREATMENT TRIALS.
I'M SHOWING A FIGURE FROM THE
NIH CONFERENCE HELD IN DECEMBER
2023, PRESENTED BY JARRED
YOUNGER, WHO USED MRS TO SHOW
THAT THERE'S INCREASED LACTATE
IN THIS ME/CFS BRAIN SHOWN HERE,
THAT'S A FINDING THAT'S BEEN
REPRODUCED IN OTHER
LABORATORIES.
BUT THERE'S ALSO SOME VERY OTHER
INTERESTING INFORMATION ON
NEUROIMAGING FROM THAT
CONFERENCE.
FINALLY, WITH REGARD TO NERVOUS
SYSTEM I WANT TO END WITH THE
ISSUE OF UNREFRESHING SLEEP, AND
THE COMMITTEE RECOMMENDED
DEVELOPMENT OF BIOMARKERS AND
UNDERSTAND CAUSES OF SLEEP PHASE
REVERSALS IN THE DISEASE.
A LOT OF PEOPLE DON'T REALIZE
THERE'S CIRCADIAN RHYTHM
DISTURBANCE AND IT'S SOMETHING
IMPORTANT TO INVESTIGATE.
NOW, WITH REGARD TO THE FIVE
ADDITIONAL WEBINAR TOPICS, I
CAN'T GO INTO DETAIL.
SYSTEMS INTERACT, WE'RE DIVIDING
THEM INTO EIGHT TOPICS
ARBITRARILY.
NERVOUS SYSTEM IS INVOLVED, AND
MANY OTHERS.
I'LL GO THROUGH FIVE AND GIVE A
BRIEF MENTION OF WHAT YOU CAN
FIND IF YOU READ THE REPORT OF
EACH OF THESE FIVE WEBINARS, AS
FAR AS WHAT ARE CONSIDERED
RESEARCH PRIORITIES, WHAT WE
KNOW NOW AND WHAT WE NEED TO
KNOW.
WITH REGARD TO CIRCULATION,
THERE'S EVIDENCE FOR
ENDOTHELIITIS, INAPPROPRIATE
VASOCONSTRICTION AND PLATE LIT
HYPERACTIVATION AND MICRO CLOTS
BUT LITTLE IS KNOWN.
LOW BLOOD VOLUME EXISTS IN A
NUMBER OF INDIVIDUALS WITH
ME/CFS, ESPECIALLY WOMEN.
ORTHOSTATIC INTOLERANCE AND LOW
CEREBRAL FLOOD BLOW HAS BEEN
OBSERVED AND IMPAIRED OXYGEN
SENSITIVITY OF RED BLOOD CELLS
AND NEUROVAST VASCULAR
DYSREGULATION ARE EXERCISE.
THIS METABOLISM/IMMUNOLOGY
INTERPLAY CAN BE DISRUPTIVE.
PROMISE OF SINGLE CELL RAMAN
TECHNOLOGY WAS HIGHLIGHTED.
COMPLEXITY OF METABOLOMICS WAS
POINTED OUT, LESS WELL DEVELOPED
AS SOME OTHER OMICS SUCH AS
PROTEOMICS OR GENE EXPRESSION
ANALYSIS.
AND IT WAS RECOMMENDED THAT A.I.
AND MACHINE LEARNING COULD BE
BROUGHT TO BEAR ON METABOLOMICS
IN ME/CFS.
ALTERED GUT MICROBIOTA CAN
AFFECT METABOLISM, THE ROLE
WORTH INVESTIGATING.
FINALLY REGARDING METABOLIC
CHARACTERIZATION OF BIOFLUIDS IT
WAS POINTED OUT YOU NEED TO HAVE
PROPER CONTROL GROUPS, THIS IS
TRUE NOT ONLY FOR METABOLISM BUT
FOR EVERYTHING, AND IT WOULD BE
BETTER TO USE HEALTHY SEDENTARY
INDIVIDUALS THAN COMPARING A
PATIENT WHO IS LARGELY HOUSE
BOUND TO SOMEONE WHO IS OUT
THERE EXERCISING DAILY.
THERE CAN ALSO BE DIETARY
INFLUENCES AND LONGITUDINAL
STUDIES ARE IMPORTANT STUDYING
THE SAME PERSON OVER TIME
ESPECIALLY.
WITH REGARD TO PHYSIOLOGY, IT
WAS DISCUSSED THAT IT'S
IMPORTANT TO DO PET IMAGING FOR
WHOLE BODY IMMUNE RESPONSES, AND
IF YOU LOOK AT THAT VIDEOCAST
FROM THE NIH DECEMBER 2023,
YOU'LL SEE VERY INTERESTING
PRESENTATION BY MICHELLE JAMES
ON PET IMAGING OF THE WHOLE
BODY.
THE CELL DANGER RESPONSE WAS
ALSO PRESENTED.
THIS IS A HYPOTHESIS, THE
SIGNALING OF INJURY OR INFECTION
IN THE CELLS THEN RESULTS IN
SUPPRESSION OF METABOLISM, THAT
COULD BE CAUSE OF FATIGUE.
IMPAIRED ENERGY PRODUCTION CAN
OCCUR THROUGH DISTURBANCE OF TCA
CYCLE IN MITOCHONDRIA.
SIMILARITIES BETWEEN CRITICALLY
ILL PEOPLE IN THE ICU AND ME/CFS
WERE POINTED OUT.
NON-REFRESHING SLEEP,
HIGHLIGHTED THAT IT'S IMPORTANT
TO KNOW ABOUT THE MOVEMENT OF
CEREBROSPINAL FLUID DURING SLEEP
AND AS WELL AS GLYMPHATIC FLOW,
DISTURBANCES COULD BE RESULTING
IN COGNITIVE IMPAIRMENT AS WELL
AS OTHER SYMPTOMS.
THE ENZYME BH4 AND NITRIC OXIDE
SIGNALING IS OF INTEREST BECAUSE
DISTURBANCE IN NITRIC OXIDE
COULD EXPLAIN SOME ABNORMAL
SYMPTOMS SUCH AS
VASOCONSTRICTION OR
VASODILATION.
AND THEN SIGNALING BY
CIRCULATING EXTRACELLULAR
VESICLES IS ANOTHER TOPIC WORTH
INVESTIGATING FURTHER.
WITH REGARD TO LESS STUDIED
PATHOLOGIES, CONNECTIVE TISSUE
DISORDERS ARE IMPORTANT IN THE
ILLNESS BECAUSE THAT'S SOMETHING
THAT'S A KNOWN RISK FACTOR FOR
ME/CFS.
AND THERE ARE SPINAL AND
MECHANICAL CONDITIONS SUCH AS
CRANIAL CERVICAL INSTABILITY AND
TETHER THE CORD, SOME SEEM TO
ARRIVE AFTER A VIRAL ONSET OF
THE ILLNESS.
AND HOW THAT CAN HAPPEN IS
SOMETHING WE DON'T UNDERSTAND.
AND THESE ARE LESS DIAGNOSED
PROBABLY THAN THEY SHOULD BE.
MAST CELL ACTIVATION DISORDERS
ARE SEEN IN A SUBSET OF
PATIENTS, MANY PATIENTS COMPLAIN
GASTROINTESTINAL PROBLEMS, AND
NEUROENDOCRINE DYSFUNCTION
ESPECIALLY PAYING ATTENTION TO
SEX DIFFERENCES GIVEN THIS IS A
FEMALE PREDOMINANT DISEASE AS
WELL AS REPRODUCTIVE HEALTH
CONDITIONS COULD BE STUDIED
FURTHER.
WITH REGARD TO GENOMICS AND
GENETIC SUSCEPTIBILITY THERE'S
NO SINGLE GENE CAUSING ME/CFS,
IT'S NOT A GENETIC DISEASE IN
THAT WAY.
BUT THERE ARE SMALL INDIVIDUAL
EFFECTS OF GENETIC FACTORS THAT
HAVE BEEN SEEN IN ME/CFS.
THERE ARE SOME GENOME-WIDE
ASSOCIATION STUDIES, MOST OF
WHICH RESULTS ARE NOT PUBLISHED.
THERE'S BEEN MINING OF U.K.
BIOBANK DATA, AND THERE'S
CURRENTLY A LARGE GWAS GOING ON
IN THE U.K. CALLED DECODE M.E.
TO PROVIDE IMPORTANT INFORMATION
ABOUT GENETIC STABILITY.
THERE HAVE BEEN FAMILY STUDIES
IN CASE REPORTS, FAIRLY MINIMAL,
ALSO RECOMMENDED TO EXPAND, AS
WELL AS FURTHER INVESTIGATION OF
EPIGENETICS.
SO I WANT TO NOW GO THROUGH THE
OVERARCHING PRIORITIES THAT WERE
RECOMMENDED BY THE COMMITTEE.
THESE ARE ALL -- FROM ALL EIGHT
WOMEN, THIS IS AN AMALGAMATION
OF ALL THOSE PRIORITIES THAT
CROSS-CUT ALL THE DIFFERENT
TOPICS.
ONE OF THEM THERE SHOULD BE
COLLABORATION BETWEEN
RESEARCHERS, CLINICIANS, AND
PEOPLE WITH ME/CFS AS WELL AS
THEIR ADVOCATES INVOLVING
MULTI-DISCIPLINARY SEARCH
COOPERATION AND DATA SHARING.
AND TO TAKE ADVANTAGE OF
N-of-1 ANECDOTAL REPORTS I
KNOW OF AT LEAST ONE TREATMENT
THAT WORKS ON A SUBSET OF
INDIVIDUALS THAT WAS ACTUALLY
RESULTING FROM A PATIENT TELLING
HER DOCTOR THAT IT WAS -- A
TREATMENT FOR SOMETHING ELSE WAS
HELPING HER ME/CFS CONDITION.
SO, IT WAS ALSO POINTED OUT WE
NEED AN INNOVATIVE APPROACH TO
DEVELOP DIAGNOSTIC MARKERS,
THERAPEUTIC TARGETS AND
PERSONALIZED TREATMENTS.
AND THAT THERE'S REALLY AN
URGENCY TO THIS BECAUSE
INDIVIDUALS WITH ME/CFS WHO
BECAME ILL IN THE 198 0s
OUTBREAK WILL HAVEN SICK MOST OF
THEIR LIVES.
SOMETHING DEEMED IMPORTANT, I
AGREE WITH THIS, EXPANSION OF
BIOBANKS IS ESSENTIAL TO
FACILITATE STUDIES BY
INVESTIGATORS NEW TO ME/CFS.
WHEN I FIRST STARTED WORKING ON
THE ILLNESS THIS WAS ONE OF THE
MOST DAUNTING CHALLENGES THAT I
FACED, BECAUSE THERE WAS NO, AT
THAT TIME, ANY BIOBANK I COULD
CONSULT AND OBTAIN SAMPLES FROM.
SO I HAD TO MAKE AN ARRANGEMENT
WITH AN ME/CFS EXPERT PHYSICIAN
SUCH AS CINDY BATEMAN, AND IT IS
AN EXAMPLE OF ONE OF THESE
EXPERT PHYSICIANS AND THAT'S
WHAT MOST PEOPLE HAVE TO DO IF
THEY WANT TO WORK ON THE
ILLNESS.
NOW THERE'S A SMALL BIOBANK,
MAINTAINED BY NIH, BUT IT NEEDS
TO HAVE MORE SAMPLES IN IT, MORE
DIVERSE TYPES OF SAMPLES.
SO, MOST SAMPLES AND MOST
BIOBANKS ARE PLASMA, SERUM, AND
PBMCs.
WE ALSO NEED CEREBROSPINAL
FLUID, TISSUE AND ORGAN SAMPLES,
NOT JUST BLOOD DERIVATIVES IN
BIOBANKS, THE NUMBER ONE ISSUE
PREVENTING INVESTIGATORS AS WELL
AS FUNDING OF COURSE FROM
STARTING TO WORK ON THE ILLNESS.
WE ALSO NEED TO HAVE
INDIVIDUAL-CENTERED CARE, AND WE
SHOULD BE INVOLVING PEOPLE
AFFECTED BY ME/CFS IN THE
RESEARCH AND DECISIONS.
AND SOMETHING MANY OF THE PEOPLE
WITH LIVED EXPERIENCE COMMENTED
ON IS THEY ARE WILLING TO ACCEPT
MORE RISK THAN SOMEONE MIGHT
ACCEPT IF THEY HAD A REASONABLE
CONDITION.
SO, MANY OF THESE INDIVIDUALS
REALLY ARE -- HAVE BEEN SICK FOR
DECADES, CONFINED TO THEIR HOMES
OR THEIR BEDS, AND THEY SAY THAT
THEY ARE WILLING TO ACCEPT MORE
RISK IN THE HOPES OF GETTING
BETTER.
THE HETEROGENEITY ALSO MEANS
TREATMENTS MUST BE TAILORED TO
SUBGROUPS.
ANOTHER RECOMMENDATION WAS TO
HAVE RIGOROUS RESEARCH IT HAS TO
HAVE ADEQUATE COHORT SIZES, MANY
STUDIES DON'T HAVE ADEQUATE
COHORT SIZES BECAUSE OF FUNDING
LIMITATIONS.
AND ALSO THE IMPORTANCE OF
REPRESENTED DEMOGRAPHICS.
I MENTIONED BEFORE THERE'S
FEMALE PREDOMINANCE BUT THERE'S
ALSO STAGE OF ILLNESS, MOST
INDIVIDUALS WHO HAVE BEEN SICK
FOR FIVE YEARS WILL NOT RECOVER,
MOST OF THE PEOPLE SICK LESS
THAN FIVE YEARS WILL ALSO NOT
RECOVER BUT IF THERE IS ANY
RECOVERY USUALLY IT'S IN THE
FIRST FIVE YEARS.
SO, SEX-SPECIFIC DATA ANALYSIS
IS ESSENTIAL.
THERE'S FEMALE PREDOMINANCE BUT
THERE'S ALSO ALREADY EXISTING
KNOWLEDGE OF DIFFERENCES AT THE
MOLECULAR LEVEL BETWEEN
BIOLOGICAL FEMALES AND MALES.
THE SUBTYPES OF ME/CFS MUST BE
CONSIDERED WHEN ANALYZING DATA.
THERE ARE A NUMBER OF EXAMPLES,
WELL NOT A LOT BECAUSE THERE
AREN'T A LOT OF CLINICAL TRIALS
YET, BUT THERE HAVE BEEN
CLINICAL TRIALS IN WHICH
PERHAPS, 10 OR 20% OF PEOPLE
SEEM TO BE GETTING BETTER AS A
RESULT OF THE TREATMENT, AND YET
THIS WAS IGNORED BECAUSE OVERALL
THERE WASN'T STATISTICAL
DIFFERENCES.
BUT IF YOU CONSIDER SUBTYPES FOR
THOSE 10 TO 20% OF THE
INDIVIDUALS, SOME OF THEM
GENUINELY IMPROVED AND THOSE
TREATMENTS SHOULD NOT BE
DISCARDED BECAUSE THEY ARE ONLY
HELPING A SUBTYPE.
IT WOULD BE IMPORTANT TO TAKE
ADVANTAGE OF MACHINE LEARNING
AND A.I. METHODS, AND IT'S
IMPORTANT TO EDUCATE HEALTHCARE
PROVIDERS.
MANY HEALTHCARE PROVIDERS KNOW
NOTHING ABOUT ME/CFS, THERE'S
NO BLOOD OR URINE TEST, FOR
EXAMPLE, AND IDENTIFY SOMEONE
THAT RESULTS IN DELAYED
DIAGNOSIS CINDY RECOMMENDED,
FIVE OR SIX YEARS IS NOT
UNTYPICAL, IOM REPORT THOUGHT --
STATED LIKELY 85% OF PATIENTS
WAY NOT BE DIAGNOSED PROPERLY OR
AT ALL.
THE OTHER THOUGHT WAS THAT
CLINICAL TRIALS NEED TO BEGIN
IMMEDIATELY.
AND THIS BEARS ON THE EDUCATION
OF HEALTHCARE PROVIDERS TOO,
THAT THE EXPERT CONDITION --
NUMBER OF EXPERT CLINICIANS
BECAME INVOLVED DURING THE 1980
ME/CFS OUTBREAKS, ESPECIALLY IF
THERE WAS ONE IN THEIR REGION.
THEY ARE NOW AGING OUT OF THE
PROFESSION.
THERE'S A HUGE AMOUNT OF
INFORMATION THAT WILL BE LOST
WHEN THEY RETIRE.
AND THERE NEEDS TO BE GUIDANCE
FOR THOSE WHO WILL BE
RESPONSIBLE FOR THE MILLIONS WHO
HAVE ME/CFS WHO ARE STILL ILL
TODAY.
IT WAS ALSO DEEMED THERE'S
ADEQUATE INFORMATION TO BEGIN
CLINICAL TRIALS EVEN THOUGH WE
ALSO DO NEED MORE FUNDAMENTAL
RESEARCH.
AND IT'S IMPORTANT FOR THESE
CLINICAL TRIALS TO INCORPORATE
CORRECTLY DIAGNOSED INDIVIDUALS.
IT WAS RECOMMENDED TO HAVE
CLINICAL TRIAL NETWORKS FOR
ME/CFS, AND TO REPURPOSE KNOWN
DRUGS ACCORDING TO EXISTING
KNOWLEDGE USING EXISTING
KNOWLEDGE, ONE COULD REPURPOSE
DRUGS AND TEST THEM IN CLINICAL
TRIALS.
AND THE CLINICAL TRIALS CAN HAVE
ANOTHER BENEFIT IN THAT THEY CAN
ACTUALLY RESULT IN NEW
INFORMATION ABOUT ME/CFS BECAUSE
IF YOU CARE SAMPLES FROM
INDIVIDUALS BEFORE AND AFTER
TREATMENT, IT'S POSSIBLE TO
OBTAIN INSIGHTS INTO THE
PATHOPHYSIOLOGY OF THE DISEASE
TO SEES WHAT MAKES SOMEONE
BETTER, WHAT MAKES SOMEONE
WORSE, HOW DO THEIR MOLECULAR
MARKERS CHANGE.
AND LONGITUDINAL STUDIES OF THE
SAME INDIVIDUAL OVER TIME CAN
PROVIDE MORE INFORMATION IN THE
SINGLE TIME POINT CARE --
COMPARISONS OF COHORTS PARTLY
BECAUSE OF FUNDING CONSTRAINTS.
AND THE OTHER COMMENT THAT I
THINK IS VERY IMPORTANT IS THAT
STANDARDIZED AND VALIDATED TOOLS
ARE AVAILABLE TO ASSIST OUTCOMES
OF TREATMENT TRIALS NOW.
I'VE HEARD IT STATED, OH, WE
CAN'T DO CLINICAL TRIALS BECAUSE
WE DON'T HAVE AN OBJECTIVE SET
OF MOLECULAR MARKERS THAT WE CAN
TELL WHETHER SOMEONE IS GETTING
BETTER OR NOT.
BUT THE FACT IS WE HAVE A LARGE
NUMBER OF, FOR EXAMPLE,
DEPRESSION DRUGS THAT WERE NOT
DEVELOPED BECAUSE YOU HAD
MOLECULAR MARKERS FOR DEPRESSION
BUT BECAUSE YOU ASKED THE
SUBJECTS ARE YOU FEELING BETTER,
IS YOUR DEPRESSION GONE, AND WE
HAVE TOOLS THAT WE CAN DO THE
SAME THING TO ASSESS THE
SYMPTOMS OF ME/CFS WHETHER
INDIVIDUALS ARE IMPROVING OR
NOT.
I FEEL A LOT OF IDEA THIS CAN'T
BE USED IS BECAUSE OF THE
STIGMA, INCORRECT STIGMA OF IT
NOT BEING A BIOLOGICAL ILLNESS.
IT IS A BIOLOGICAL ILLNESS AND
PATIENTS CAN ACCURATE REPORT IF
THEY ARE FEELING BETTER.
SO, THERE ARE PROMISING
OBJECTIVE MARKERS.
THEY CAN ALSO BE USED BUT
CLINICAL TRIALS NEED NOT WAIT
WHILE ADDITIONAL MEASURES ARE
DEVELOPED.
I'D LIKE TO TURN THIS BACK OVER
TO VICKY TO TALK ABOUT NEXT
STEPS.
>> THANK YOU, CINDY AND MAUREEN.
IN COUNCIL ACCEPTS THIS REPORT,
TRANS-NIH ME/CFS WORKING GROUP
FROM REPRESENTATIVES OF THE 21
INSTITUTES AND CENTERS WILL MEET
AND DEVELOP A PLAN TO ADDRESS
THE RESEARCH PRIORITIES
IDENTIFIED IN THE RESEARCH
ROADMAP, AND OUR PLAN IS ALSO TO
WORK TOGETHER WITH FEDERAL
PARTNERS, NON-PROFIT
ORGANIZATIONS, TO REALLY FIGURE
OUT THE LANDSCAPE AND HOW WE CAN
MOVE ALL OF THE RESEARCH
PRIORITIES FORWARD, TOGETHER.
AND ABSOLUTELY INCLUDE PEOPLE
WITH LIVED EXPERIENCE WHO BRING
THEIR EXPERIENCE AND PERSPECTIVE
TO THE RESEARCH.
SO POTENTIAL NEXT STEPS AND
ACTUALLY ONE NEXT STEP IS THERE
WILL BE A NEW FUNDING
OPPORTUNITY, THE CONCEPT WAS
APPROVED AT FEBRUARY COUNCIL.
AND THIS WILL BE LAUNCHED SOON.
WE ARE ALREADY THINKING ABOUT
AND TALKING ABOUT DEVELOPING AND
ME/CFS GENETICS CONSORTIUM, AS
YOU HEARD THERE WAS A LOT OF
INFORMATION THAT WAS PRESENTED
IN THE GENETICS WEBINAR THAT'S
UNPUBLISHED, AND PRETTY
EXTENSIVE DATA, BOTH FROM
COHORTS OF ME/CFS FROM COHORTS
OF INDIVIDUALS WITH LONG COVID,
SOME OF WHOM MEET THE CASE
DEFINITION FOR ME/CFS.
SO THERE'S A LOT OF DATA OUT
THERE, THE GENETICS
INVESTIGATORS ARE VERY ANXIOUS
TO COME TOGETHER AND REALLY MOVE
THAT FORWARD.
WE CLEARLY NEED FURTHER AND
ONGOING DISCUSSIONS ABOUT MOVING
CLINICAL TRIALS FORWARD.
SO WE'RE ALREADY THINKING ABOUT
AND PLANNING TO DEVELOP A
CLINICAL TRIAL WORKING GROUP,
ROUNDTABLES, THERE WILL BE A
DISCUSSION ABOUT CLINICAL TRIALS
AT AN UPCOMING ME/CFS MEETING
ORGANIZED BY INVEST IN M.E. IN
THE U.K. IN JUNE.
WE'RE THINKING ABOUT WAYS TO
MOVE THIS FORWARD.
ONE THING NOT ON THE SLIDE,
PRETTY EXCITING, IS THAT IN
DECEMBER IN CONJUNCTION WITH
ME/CFS/NIH CONFERENCE, A YOUNG
INVESTIGATOR MEETING WITH OVER
100 YOUNG INVESTIGATORS, EARLY
CAREER, FROM THE U.S.,
AUSTRALIA, EUROPE, FROM AROUND
THE WORLD WHO JOINED US
VIRTUALLY.
THERE'S A REALLY COMMITTED
EFFORT TO KEEP THEM TOGETHER TO
HELP SUPPORT THEM IN THEIR
EFFORTS TO BUILD THEIR CAREERS
AND DO RESEARCH ON ME/CFS.
I'LL END BY FIRST OF ALL
THANKING MY COLLEAGUES AT NINDS,
WHO WITHOUT THEIR HELP NONE OF
THIS WOULD HAVE BEEN POSSIBLE.
ALSO THANK OUR CONTRACTOR, LOW
JUSTICE CONTRACTORS AT RLA, ALSO
AMAZING, AND WE COULDN'T HAVE
DONE THE EIGHT WEBINARS AND THIS
WHOLE PROCESS WITHOUT THEM
EITHER.
I'LL STOP THERE.
THE NEXT SLIDE I THINK IS JUST
FOR QUESTIONS.
OH, SORRY, ONE MORE SLIDE.
THERE'S A LOT OF INFORMATION,
THE ROADMAP WILL BE POSTED IF
ACCEPTED BY COUNCIL ON THE NINDS
WEBSITE.
ALL OF THE WEBINARS ARE
AVAILABLE FOR ANYONE WHO IS
INTERESTED TO VIEW THEM BY GOING
TO THE NINDS ADVISORY COUNCIL
WEBSITE.
SO WITH THAT I WILL STOP AND BE
HAPPY TO TAKE QUESTIONS.
>> THANK YOU FOR THE
PRESENTATION.
I AGREE WITH INITIATIVES
CONSIDERED.
ONE THING I WANTED TO MENTION IN
THE NEURODEGENERATIVE DISEASE
REALM, WE'VE REALIZED ULTIMATELY
THE HETEROGENEITY WE REALLY
UNDERSTAND, WE LOOK AT THE
BRAINS OF PEOPLE WHO HAVE DIED.
I THINK IT'S ABSOLUTELY
APPROPRIATE NOT TO BE FOCUSED ON
PEOPLE WHO DIE WHO HAVE ME/CFS
BUT IT WOULD BE A LOST
OPPORTUNITY IF WE'RE NOT
COLLECTING AUTOPSY SPECIMENS.
I'D LIKE TO HEAR FROM CINDY OR
MAUREEN ABOUT EFFORTS TO COLLECT
NOT ONLY BIOSAMPLES, WHICH ARE
IMPORTANT, BUT BRAINS OF
INDIVIDUALS WHO PASSED AWAY WITH
THIS CONDITION.
REALITY IS WE NEED TO LOOK AT
THINGS LIKE TRANSPOSABLE
ELEMENTS, ENDOGENOUS
RETROVIRUSES, EPIGENETICS WITHIN
THE BRAIN AS WELL.
>> I QUITE AGREE BUT MAYBE VICKY
WOULD LIKE TO TALK ABOUT CURRENT
STATUS OF DOING THAT.
>> INDIVIDUALS WITH ME/CFS DO
HAVE THE OPPORTUNITY TO
RE-REGISTER, AND/OR AT THE TIME
OF DEATH FOR NEXT OF KIN TO
DONATE BRAINS OR OTHER TISSUES
TO THE NIH NEUROBIOBANK.
WHICH WE HAVE HAD SOME DONATIONS
COME IN TO THE NIH NEUROBIOBANK.
IT'S A QUITE CHALLENGING ISSUE
TO DISCUSS, SENSITIVE ISSUE TO
DISCUSS WITH THE COMMUNITY
BECAUSE THERE CONTINUE TO BE
SUICIDES, INDIVIDUALS WHO
COMPLETELY LOSE HOPE, AND COMMIT
SUICIDE TO END THEIR SUFFERING.
AND SO IT'S REALLY A SENSITIVE
TOPIC TO TALK ABOUT THINKING
ABOUT DONATING YOUR BRAINS WHEN
YOU DIE.
BUT IT'S SOMETHING THAT IS
CRITICALLY IMPORTANT AND
SOMETHING THAT WE ARE WORKING
TOWARD.
>> YES, I COMPLETELY HEAR WHAT
YOU'RE SAYING.
IT IS AN IMPORTANT AND SENSITIVE
ISSUE.
BUT UNLESS WE ACTUALLY HAVE THAT
DISCUSSION, WE WON'T BE GETTING
THE TISSUES ULTIMATELY THAT WE
NEED.
IT IS A BIOLOGICAL CONDITION BUT
UNDERSTANDING THE BIOLOGY
REQUIRES WE ALSO LOOK AT THE
BRAINS WHEN PEOPLE HAVE PASSED
AWAY.
AND I KNOW YOU'RE CORRECT THAT
IT'S DIFFICULT TO ADDRESS THAT
ISSUE, PARTICULARLY IN THIS
POPULATION, BUT IT'S SOMETHING
THAT WOULD BE A LOST OPPORTUNITY
IF WE'RE NOT THINKING ABOUT IT
PROACTIVELY.
>> IF YOU CONSIDER LONG COVID,
SOME MAJOR FINDINGS ABOUT THE
PREVALENCE OF SARS-COV-2 CAME
FROM THOSE AUTOPSY SAMPLES,
CRITICAL TO HAVE NOT JUST THE
BRAIN BUT SPINAL CORD, FOR
EXAMPLE, TO FIND OUT WHETHER
THERE'S DAMAGE OR WHETHER THERE
IS STILL THE VIRUS PRESENT.
>> IT MIGHT BE INTERESTING, I'LL
JUST ADD, ONE PATIENT ASKED ME
THIS QUESTION YESTERDAY IN HER
VISIT.
VERY GENUINELY, NOT FROM A STATE
OF DEPRESSION.
IT MAY BE SOMETHING WE NEED TO
TALK ABOUT MORE AND HAVE IT
BECOME AN ORDINARY CONVERSATION.
>> THE FOLLOWING IS HANK'S
QUESTION.
YOU COLLECTED CLINICAL DATA IN
THE HISTORY OF THEIR DISEASE,
GIVEN THE VARIANTS AND
VARIABILITY WE HAVE TO KEEP AS
MUCH CLINICAL INFORMATION
ALONGSIDE BIOLOGICAL SAMPLES,
INCREDIBLY HELPFUL, CONCEPTED,
ABLE TO BE USED AND SHARED AND
COMBINED WOULD BE VALUABLE IN
THE FUTURE.
>> CINDY SHOULD ANSWER THAT ONE,
I THINK.
>> YEAH, I MEAN, IT IS
IMPORTANT.
WHAT WE CONSIDER A GOLD MINE OF
NATURAL HISTORY INFORMATION IN
MOST CLINICS.
BUT IT'S -- A LOT OF IT IS
PRE-ELECTRONIC HEALTH RECORD,
DIFFICULT AND CHALLENGING.
THERE ARE CODING PROBLEMS.
BUT I THINK IT'S REALLY
IMPORTANT AND WHEN WE WERE PART
OF THE COLLABORATIVE RESEARCH
CENTER WITH JACKSON LABS, WE DID
A LOT OF ANALYSIS OF THE
SUBJECTIVE INFORMATION THAT WE
COLLECTED.
I THINK ALL OF THAT WILL BE
IMPORTANT.
>> IF I CAN JUST ADD NIH HAS
BEEN FUNDING COLLABORATIVE
RESEARCH CENTERS.
THEY ARE NOW IN THEIR SIXTH
YEAR.
RECENTLY RENEWED.
AND ALL OF THE DATA FROM THOSE
CENTERS AS WELL AS THE DATA FROM
THE RECENT INTRAMURAL STUDY HAVE
BEEN UPLOADED TO DATA PORTAL
CALLED MAP ME/CFS, AVAILABLE FOR
REANALYSIS AND FOR
INVESTIGATORS.
BUT THERE'S EXTENSIVE CLINICAL
DATA TOGETHER WITH ALL THE OMIC
DATA THAT WAS COLLECTED AS WELL.
>> THAT'S GREAT, PARTICULARLY
ASSOCIATING SAMPLES WITH
INDIVIDUAL CLINICAL COURSE,
THAT'S HUGELY VALUABLE.
>> YES, THANK YOU.
>> AND LOUISE PUT A COME ON THE
CHAT ABOUT APPROACHING MEDICAL
EXAMINE.
FLORIAN?
>> SOME SUICIDES WILL END UP THE
IN THE MEDICAL EXAMINERS.
SOMETIMES THAT'S WHERE WE CAN
GET PATIENTS FOR LIKE SOME
ADDICTION STUDIES.
THERE'S A WOMAN HERE THAT DOES A
LOT OF THAT.
SO, TAPPING INTO THOSE.
BUT I FOUND LIKE WE'VE BEEN
RUNNING THIS RAPID AUTOPSY
SERVICE FOR 12 MONTHS.
IT'S DIFFICULT WITH SUDDEN
DEATH, TRYING TO GET MORE
CONTROLS LIKE FROM MOTOR VEHICLE
ACCIDENTS BUT SURPRISING IF YOU
JUST TAKE IT THROUGH LIKE IN A
VERY KIND OF STANDARDIZED WAY
HOW MANY PEOPLE ARE INTERESTED
IN THAT.
I DON'T THINK IT WILL INFLUENCE,
YOU KNOW, OBVIOUSLY THEIR CARE
OR ANYTHING, BUT SOMETIMES
TALKING ABOUT IT EARLY PEOPLE
ARE ACTUALLY MORE AMENABLE THAN
YOU THINK.
BUT IT'S A DIFFICULT DISCUSSION.
IF YOU'RE TALKING ABOUT A BUSY
CLINICIAN WHO IS IN, YOU KNOW, A
CLINICAL PRACTICE SEEING THESE
PATIENTS, YOU JUST WANT TO TRY
AND STANDARDIZE THINGS TO MAKE
IT EASY FOR THEM.
>> THANK YOU, LOUISE.
YEAH, APPRECIATE THE OVERVIEW.
I CAN FORESEE SUCH CHALLENGES,
RAISING AWARENESS AROUND THIS,
AND HIGHLIGHTING THE COMPLEXITY
OF CLASSIFICATION AND CAUSALITY
HERE.
IN PARTICULAR I FORESEE THERE
ARE GOING TO BE REAL ISSUES IN
THINKING ABOUT SOME OF THAT.
SO WHAT YOU SAID ABOUT SUBTYPING
AND STAGES OF DISEASE REALLY
RESONATED WITH ME.
I THINK THEY WILL BE KEY TO
STRATIFICATION.
ANY THOUGHTS HOW YOU'RE GOING TO
ROADMAP AND ENCOURAGE THAT?
I THINK THAT WILL BE REALLY
CRITICAL.
THANKS SO MUCH.
THAT WAS A TERRIFIC
PRESENTATION.
>> CINDY, MAUREEN, DO YOU WANT
TO RESPOND?
WOULD YOU LIKE ME TO RESPOND?
>> WELL, ONE CERTAINLY CAN
SUBTYPE BY CLUSTERING SYMPTOMS.
SOMEONE IN MY LAB, FOR EXAMPLE,
WAS ABLE TO IDENTIFY FOUR
SUBTYPES JUST FROM THE SYMPTOMS.
AND THE ALAIN MARROW CENTER IN
CANADA HAS BEEN SUBTYPING
ACCORDING TO MOLECULAR
INFORMATION, SOMETHING GOING ON,
BUT IT'S IMPORTANT TO USE IT
ESPECIALLY IN CLINICAL TRIALS.
I THINK WE DON'T WANT TO THROW
OUT A DRUG AS BEING USEFUL EVEN
IF IT ONLY GIVES 10% OF PEOPLE
BACK THEIR LIVES IT'S
WORTHWHILE.
FRANCES HAD HER HAND RAISED
NEXT.
>> I DO.
HAY.
I WAS WONDERING THINKING ABOUT
ACROSS NIH AREAS OF COMMON
INTEREST WHETHER -- HAVE YOU
BEEN FOCUSING AT ALL ON THE
AGING BRAIN WITH ME/CFS?
IS THERE AN INTERACTION BETWEEN
RISK FOR DEMENTIA, I KNOW SLEEP
DISTURBANCE IS RELATED
INDEPENDENTLY BUT IS THERE AN
INTERACTION BETWEEN THIS
DISORDER AND NEURODEGENERATIVE
DISEASE OF ANY KIND?
GIVEN THE AGING POPULATION,
MIGHT BE AN IMPORTANT ELEMENT TO
BUILD IN.
>> I COULD TAKE A STAB AT THAT.
I'M NOT SURE WE'VE LOOKED AT IT
SPECIFICALLY IN THAT WAY.
FROM THE CLINICAL STANDPOINT, IT
SEEMS USUALLY KIND OF DIFFERENT,
CLINICAL PRESENTATION, THAN
DEMENTIA-LIKE CHANGES.
BUT WHAT WE SEE IN --
>> I WASN'T SUGGESTING IT WAS
DEMENTIA.
I'M JUST LONGITUDINALLY, AS YOU
FOLLOW PEOPLE, DO THEY HAVE AN
INCREASED RISK.
>> RIGHT, RIGHT, RIGHT.
I DON'T KNOW THE ANSWER TO THAT
BUT I ALSO KNOW THAT AGE-RELATED
CHANGES GET SUPERIMPOSED AS
PEOPLE GET OLDER, SEEMS TO BE
PREMATURE BUT JUST AN IMPRESSION
ON MY PART.
>> I DON'T KNOW WHETHER YOU HAVE
A GREATER RISK OF DEMENTIA AS A
RESULT OF HAVING HAD ME/CFS.
>> YEAH, I'M NOT AWARE THAT THAT
HAS BEEN INVESTIGATED BUT I'M
NOT AWARE THERE IS AN INCREASED
RISK.
BUT I DO KNOW THAT THERE'S DATA
THAT WILL BE PUBLISHED SOON FROM
THE JACKSON LABS CENTER THAT
INVESTIGATED IMMUNE PROFILING OF
INDIVIDUALS WHO WERE EARLY ON IN
THEIR DISEASE VERSUS THOSE THAT
HAD BEEN ILL FOR A MUCH LONGER
PERIOD OF TIME, AND THERE ARE
SIGNIFICANT DIFFERENCES AS WELL
AS DIFFERENCES IN IMMUNE
PROFILING FROM YOUNGER
INDIVIDUALS COMPARED TO PEOPLE
OVER THE AGE OF 60.
SO, THERE ARE DEFINITELY
AGING -- AGE-RELATED CHANGES,
BUT I'M NOT AWARE OF ANY
DEMENTIA-RELATED.
>> OKAY.
WALTER, HOW ABOUT YOU ARE THE
LAST QUESTION?
>> THERE'S OBVIOUS DATA WHEN YOU
COMPARE CONTROLS TO AFFECTED
PEOPLE MANY INSTANCES YOU
COULDN'T SEE A DIFFERENCE, BUT
WHEN YOU ACTUALLY BROKE IT DOWN
TO MALES OR FEMALES, BIG
DIFFERENCES APPEARED.
SO, EVEN THOUGH YOU HAD A
SMALLER N, THE DIFFERENT GENDER
SPLIT REALLY LED TO
ABNORMALITIES JUMPING OUT.
TWO VERY SIMPLE QUESTIONS.
ONE THAT'S ALWAYS BEEN BUGGING
ME IS THE CAUSE OF THE
SPORADICS, GIVE THAN COVID-19 IS
A CORONAVIRUS, LOTS OF
CORONAVIRUSES HAVE BEEN AROUND
FOREVER IS ANYBODY THINKING IT'S
ACTUALLY A CORONAVIRUS DRIVING
SPOREATICS ALL D. -- SPORADICS.
>> WE CAN'T RULE OUT A BAD
VARIANT CAUSING ME/CFS.
THAT'S CERTAINLY A POSSIBILITY.
I CAN'T ELIMINATE IT.
WE DO KNOW IN SOME CASES, SOME
OF THE SPORADIC CASES, THE
INDIVIDUAL DID HAVE AN
ENTEROVIRUS INFECTION.
SO THERE IS EVIDENCE OF
ENTEROVIRUS INFECTION IN SOME
CASES, BUT I DON'T KNOW OF ANY
CASE SOMEONE HAS LOOKED FOR A
CORONAVIRUS TO FIND OUT IF IT
COULD HAVE CAUSED ME/CFS.
BUT THAT REMAINS A POSSIBILITY.
AND AT THIS POINT IF YOU GET
ME/CFS AFTER 2020, WE DON'T KNOW
WHETHER YOU GOT IT FROM
SARS-COV-2 OR WHETHER YOU GOT IT
FROM A VIRUS THAT'S STILL AROUND
THAT EXISTED AND CAUSED IT
PRE-2020.
>> THE OTHER QUESTION IN TERMS
OF HETEROGENEITY SINCE WE RAN
INTO THIS WITH LONG COVID CASES,
AND SO WE LOOK AT THE DATA AND
WE SEPARATE IT INTO MULTIPLE
DIFFERENT GROUPS AND PUT UP
CLINICAL TRIAL PLATFORMS FOR
EACH OF THE GROUPS, AUTONOMICS,
SLEEP, COGNITIVE TROUBLE,
EXERCISE.
I'M NOT SURE HOW MUCH YOU KNOW
OF DETAILS BUT OF THOSE
PLATFORMS, ARE THEY ACTUALLY
READY TO TEST SIMILAR SUBGROUPS
OF ME/CFS PATIENTS?
THAT MAY NOT HAVE BEEN LONG
COVID?
>> I THINK A LOT OF THE -- I CAN
ANSWER THAT A LOT OF THE
CLINICAL TRIALS THAT I'VE SEEN
COMING FORWARD FOR LONG COVID,
THE DRUGS ARE ONES THAT
POTENTIALLY ADDRESS SOME OF THE
SAME SYMPTOMS THAT PEOPLE WITH
ME/CFS HAVE.
BUT THE SUBGROUPS I'M TALKING
ABOUT ARE NOT THAT YOU HAVE
FATIGUE OR ORTHOSTATIC
INTOLERANCE OR COGNITIVE
IMPAIRMENT BECAUSE THOSE FIVE
TOGETHER ARE REQUIRED TO HAVE --
TO BE DIAGNOSED.
SO PEOPLE WHO HAVE ALL FIVE
SYMPTOMS IOF COMMITTEE
IDENTIFIED, EVEN PEOPLE WITH
THOSE FIVE SYMPTOMS, THERE BE
SUBGROUPS WHO MAY HAVE MORE
PAIN, HAVE SOME MOLECULAR
DIFFERENCE, DIFFERENT
CONSTELLATION OF SYMPTOMS BUT
ALL HAVE THE SAME FIVE SYMPTOMS.
SO, I THINK A LOT OF THE
CLINICAL TRIALS THAT ARE GOING
ON FOR LONG COVID WOULD BE
APPLICABLE TO ME/CFS, AND I
RECOMMEND THAT ME/CFS BE A
COMPARATOR GROUP FOR MANY
CLINICAL TRIALS WITH ONE
EXCEPTION.
THE ONE TYPE OF DRUG THAT IS NOT
GOING TO HELP ANYONE BEFORE
PRE-2020 ARE THE CLINICAL TRIALS
IN WHICH PEOPLE ARE GIVING THE
LONG COVID INDIVIDUALS
SARS-COV-2 DRUGS.
THOSE ARE CERTAINLY NOT HELP
ANYONE BEFORE 2020.
SO, BUT I THINK MANY OF THE
DRUGS THAT ARE BEING TRIED, LOW
DOSE NALTREXONE, FOR EXAMPLE,
HAS BEEN USED FOR YEARS IN
ME/CFS AS SOMETHING THAT HELPS A
SUBSET.
CINDY?
>> PEOPLE WHO HAVE BEEN SIX 20
YEARS, OR 10 YEARS, HAVE MADE
ALL KIND OF ADAPTATIONS AND SEEN
MANY PHYSICIANS NOT EXCITED
ABOUT A CLINICAL TRIAL TO STUDY
EXERCISE, OR SLEEP HYGIENE,
THAT'S WHY THERE'S BEEN SUCH A
BACKLASH FROM THE ME/CFS
COMMUNITY ABOUT THE
WELL-INTENDED CLINICAL TRIALS.
I'M PART OF RECOVER CLINICAL
TRIALS BUT THEY WANT TO MOVE TO
MORE EFFECTIVE PRIMARY
INTERVENTIONS AS SOON AS
POSSIBLE AND I'M SURE LONG COVID
WANTS TO DO THAT TOO, THE LONGER
THEY ARE ILL.
>> A COMMENT I'LL MAKE ON THAT,
FOR EXAMPLE, AS THE NIH
INTRAMURAL STUDY POINTED OUT,
THERE'S SOME EVIDENCE FOR T CELL
EXHAUSTION.
WHEN WE HAVE DRUGS FROM THE
CANCER WORLD TO DEAL WITH T CELL
EXHAUSTION, THOSE ARE SOME OF
THE HIGHER RISK DRUGS THAT THE
INDIVIDUALS WITH ME/CFS ARE
QUITE WILLING TO ACCEPT THE RISK
IF THE CLINICAL TRIAL WERE PUT
FORWARD.
I SUSPECT MANY PEOPLE WITH LONG
COVID WOULD ALSO BE WILLING TO
RISK THAT TYPE OF TREATMENT.
>> THANK YOU VERY MUCH.
>> THANK YOU.
CINDY, MAUREEN, VICKIE, THANK
YOU VERY MUCH.
NOW WE NEED TO ASK THE COUNCIL
IF THEY WOULD LIKE TO MAKE A
MOTION TO ACCEPT THE REPORT.
>> SO MOVED.
>> SECOND?
>> SECOND.
>> OKAY.
WE HAVE A SECOND.
SO WE'RE NOW GOING TO HAND IT
OVER TO TIM TO GET YOU THE VOTE.
>> IF EVERYONE COULD GO INTO THE
VOTING TAB OF THE ECB.
YOU'RE GOING TO SCROLL DOWN.
AND CLICK ON ME/CFS REPORT.
AND MAKE SURE YOU DO SAVE AND
SUBMIT AFTER YOU VOTE.
WE GOT THE VOTE -- WE NEED THE
WORD THAT WE GOT THE FIVE.
FIVE RIGHT NOW.
WE NEED THREE MORE.
(INAUDIBLE)
>> FOR SOME REASON MINE ISN'T --
IT SEEMED TO BE GRAYED OUT.
LOUISE, IS THAT YOU?
>> YES.
IS ANYBODY ELSE HAVING TROUBLE?
MINE SEEMS TO BE GRAYED OUT WHEN
I TRY TO CLICK YES.
I SEE THE REPORT AND PDF.
SORRY.
>> THAT'S OKAY.
>> IS ANYBODY ELSE HAVING THAT
ISSUE?
>> WE'RE FIXING THAT.
>> OKAY.
SORRY ABOUT THAT.
>> WHERE DO WE STAND?
>> MINE IS NOT LETTING ME INTO
THE VOTING TAB ALTHOUGH IT
WORKED FINE THIS MORNING.
>> I KNOW, MINE DID TOO.
>> THIS IS WEIRD.
>> IN THE INTEREST OF TIME WE
CAN TAKE -- YOU CAN VERBALLY
STATE YOUR VOTE.
>> YES.
>> YES, OKAY.
>> MINE JUST DECIDED TO WORK.
SORRY ABOUT THAT.
>> PUT IT IN THE CHAT.
JUST PUT IT IN THE CHAT.
>> YEP.
>> YAY OR NAY.
OKAY.
I'M GOING TO MOVE FORWARD.
>> IT'S A GREAT REPORT, REALLY
FANTASTIC.
>> SO, CINDY AND MAUREEN, THANKS
AGAIN.
WE'RE MOVING TO THE NEXT ITEM,
OUR BRAIN UPDATE.
AND I'M GOING TO HAND IT OVER TO
JOHN NGAI WHO IS THE BRAIN
DIRECTOR.
AND JOHN, DO WE HAVE JOHN?
>> I HAVE YOU.
DO YOU HAVE ME?
>> I DON'T SEE YOU BUT I CAN
HEAR YOU, I'LL TAKE IT AS WE DO
HAVE YOU.
>> CAN YOU SEE WHAT LOOKS TO BE
THE PROPER SCREEN?
>> I SEE YOUR SCREEN.
ALL RIGHT, JOHN, IT'S ALL YOURS.
>> I'M GOING TO REARRANGE THE
SILLY WINDOWS.
SORRY I CAN'T BE WITH YOU IN
PERSON.
AS WALTER MENTIONED EARLIER,
WE'RE NOT ALLOWED TO BE ASKING
CONGRESS FOR MONEY.
HOWEVER, WE ARE TAKING EVERY
OPPORTUNITY TO GET THE WORD OUT
ABOUT ALL THE GREAT WORK THAT
BRAIN AND IDS AND NIH GENERALLY
HAS BEEN DOING AND SUPPORTING.
MONDAY EVENING A FEW MEMBERS OF
MY TEAM AND I WERE IN PORTLAND
AT OHSU FOR AN EVENT HONORING
U.S. REPRESENTATIVE EARL
BLOOMENAEUR RETIRING AFTER 26
YEARS OF SERVICE IN THE HOUSE, A
TIRELESS CHAMPION OF
NEUROSCIENCE RESEARCH.
IN 2010 ESTABLISHED THE
BIPARTISAN CONGRESSIONAL
NEUROSCIENCE CAUCUS WHICH HE
CURRENTLY CO-CHAIRS WITH
REPRESENTATIVE MORGAN LITTRELL
FROM THE HOUSTON, TEXAS, AREA.
GIVEN AIRLINE SCHEDULES AND
FLIGHT DELAYS THIS MEANT I HAD
TO RUN OUR MCWG FOR BRAIN
YESTERDAY FROM A HOTEL ROOM IN
PORTLAND.
I COULDN'T FIND A WAY OF GETTING
BACK TO THE EAST COAST FOR
TODAY'S MEETING.
APOLOGIES FOR ZOOMING FROM THE
WEST COAST, HOPE TO SEE YOU IN
PERSON NEXT TIME.
I HAVE TO THANK THE 130 OR 135
R. 150 ARE ARE ARE ARE ARE -- -
130 OR 150 SUPPORTERS.
WE'VE FUNDED OVER 1600 AWARDS TO
OVER 1700 P.I.s ACROSS 265
INSTITUTIONS.
STILL BIASED TOWARD THE COAST
BUT SLOWLY FILLING IN IN THE
MIDDLE OF THE COUNTRY WHERE
THERE'S A LOT OF TALENT TO BE
TAPPED TO APPROACH THIS
INCREDIBLE MYSTERY CALLED THE
HUMAN BRAIN.
A LOT OF GREAT PUBLICATIONS
ACROSS DIFFERENT JOURNALS,
REPRESENTING THE TRULY
INTERDISCIPLINARY NATURE OF THE
INITIATIVE.
SO LET ME GET THE NOT SO GREAT
NEWS OUT OF THE WAY FIRST, AS
THE BUDGET ISSUES WE'RE HAVING
THAT WALTER ALLUDED TO EARLIER.
WALTER DID A GREAT JOB
EXPLAINING WHERE WE ARE.
FRANKLY I'VE HAD AN EASIER TIME
EXPLAINING SENSOR ADAPTATION TO
UNDERGRADUATES THAN WHAT
HAPPENED.
LET'S SEE IF I CAN'T EXPLAIN
WHAT'S GOING ON.
OKAY.
SO BRAIN RECEIVES FUNDING FROM
TWO SOURCES.
ONE IS THE BASE FUNDING TO THE
10 PARTICIPATING INSTITUTES AND
CENTERS IN BRAIN.
THIS TOTALS UP IN FISCAL YEAR FY
22 TO $468 MILLION.
YOU CAN SEE A STEADY ROBUST
INCREASE OVER TIME.
THE CURES ACT, 21ST CENTURY
CURES ACT, PASSED IN 2016
PROVIDED ADDITIONAL FUNDS FROM
FY 17 THROUGH FY 26.
I'M SHOWING WHAT'S GOING ON
HERE, FY 24 FOR SIMPLICITY.
NOW, THE CURES ACT AUTHORIZED
BUT NOT APPROPRIATED, IT
AUTHORIZED VARYING LEVELS OF
FUNDING OVER THE 10-YEAR PERIOD.
YOU CAN SEE YOU THE FLUCTUATES
UP AND DOWN WITH A BUMP IN 2023,
COMMITTED TO SUPPORTING
LONG-TERM EVEN AFTER CURES ACT
FUNDING EXPIRES IN 2026.
WITH THIS BUMP IN FUNDING IN FY
23 EVEN AFTER EXPIRATION IN 26,
THE ROBUST FUNDING WOULD HAVE
ALLOWED TO US CONTINUE ON
CURRENT TRAJECTORY.
HOWEVER AS WALTER MENTIONED, IN
FY 23 A DECISION WAS MADE TO
REDUCE THE BASE TO $230 MILLION,
BUT WITH CURES FUNDING
BALLOONING TO 4 $50 MILLION --
$450 MILLION WE GOT AN INCREASE
TO TO $680 MILLION IN 2023
COMPARED TO $620 MILLION IN FY
22.
THIS IS KIND OF WHAT
PRECIPITATED THE CURRENT PICKLE
WE'RE IN BECAUSE IN THE ENACTED
FY 24 BUDGET, THE BASE WAS HELD
FLAT.
IN OTHER WORDS, WE DID NOT GET A
RESTORATION OF THE BASE BUT THE
CURES ACT DROPPED BY $270
MILLION, WHICH RESULTED IN TOTAL
TOPLINE BUDGET OF $402 MILLION,
40% LESS THAN FY 23.
NOW, MAKE NO MISTAKE.
$402 MILLION IS A GOOD CHUNK OF
CHANGE.
AS ALWAYS WE'RE DOING OUR BEST
TO STEWARD INVESTMENTS TO
ADVANCE THE MISSION OF THE NIH
BRAIN INITIATIVE FOR THE BENEFIT
OF THE TAXPAYERS, FOR THE
BENEFIT OF ALL.
WE HAVE TO ASK OURSELVES WHAT
ARE WE DOING TO MANAGE THIS
DIFFICULT BUDGET ENVIRONMENT
GIVEN THAT WE'RE NOW SHORT $278
MILLION COMPARED TO LAST YEAR.
SO THE FIRST THING IS WE'RE
DOING OUR BEST TO COMMUNICATE
THE SITUATION ABOUT THE REALITY
OF THE SITUATION, AND ITS
IMPACTS.
I RELEASED A STATEMENT ON THE
WEBSITE THROUGH THE DIRECTOR'S
CORNER BLOG, INFORMING EVERYBODY
IN THE FIELD WHAT HAPPENED,
FOLLOWED UP BY A PAGE WE PUT ON
THE BRAIN WEBSITE, BASICALLY
DESCRIBING THE BUDGET OVERVIEW,
WE INCLUDED A NUMBER OF
FREQUENTLY ASKED QUESTIONS AND
I'M SURE THERE WILL BE MORE TO
COME.
AND THEN HOW WE'RE GOING TO
MANAGE THIS IMPACT.
SO, YOU CAN GET MORE INFORMATION
HERE, I'LL WALK THROUGH OUR
GENERAL STRATEGY FOR MANAGING
BUDGET DIFFICULTY FOR THE TIME
BEING.
WE WERE COMMITTED TO STAYING
TRUE TO OUR MISSION, AND CORE
VALUES TO SUPPORT INNOVATIVE,
OPEN, INCLUDESSIVE AND ETHICAL
SCIENCE.
OPERATIONALLY, WE'VE HAD TO
INSTITUTE 10% CUTS ON OUT-YEAR
COMMITMENTS.
AS WALTER MENTIONED, THE BULK OF
OUR CURRENT -- BULK OFF
OBLIGATIONS EACH YEAR ARE FROM
OUTYEAR COMMITMENTS, BETWEEN 2/3
AND 3/4 OF THE BUDGET, ALLOWS US
TO PUT MORE MORE -- MORE MONEY
INTO NEW GRANTS.
THERE ARE EXCEPTIONS, FOR
EXAMPLE INDIVIDUAL TRAINING
AWARDS, SMALL AWARDS LIKE R21s
AND SO FORTH, ALL THE
INFORMATION IS IN THE WEBSITE
HIGHLIGHTED ON THE RIGHT.
GIVEN 40% DROP IN FUNDING WE CAN
ONLY FUND PERHAPS HALF OF NEW
AWARDS THAN WE WERE HOPING TO.
WE'RE GOING THROUGH THESE GRANT
APPLICATIONS IN FRONT OF US,
MANY OF WHICH THIS GROUP HAS
SEEN, FOR THE ENTIRE YEAR.
BASICALLY MAKING SOME VERY HARD
DECISIONS ABOUT WHAT TO FUND.
WHATEVER DOESN'T GET FUNDED THIS
YEAR WE'LL DEFER.
WE HAVE THREE COUNCIL ROUNDS TO
FUND WHATEVER DOESN'T GET FUNDED
NOW SO WE'LL HAVE A BACKLOG OF
REALLY GREAT APPLICATIONS TO
FUND IF AND WHEN THE BUDGETS
GETS RESTORED.
FY 25 ISN'T LOOKING GREAT BUT
THERE'S ALWAYS HOPE.
WE WERE FORCED TO CANCEL
SELECTED UPCOMING RECEIPT DATES
AND EVEN FUNDING OPPORTUNITY
ANNOUNCEMENTS SO THAT
INVESTIGATORS, REVIEWERS AND
STAFF CAN DIRECT ENERGIES MORE
PRODUCTIVELY ELSEWHERE.
THIS HAS BEEN A TOUGH GO FOR
EVERYBODY.
WE APPRECIATE THAT BUT THIS IS
WHERE WE'RE STUCK RIGHT NOW.
WE'VE BEEN COMMUNICATING THESE
CANCELLATIONS, THE RECEIPT
DATES, VIA THE WEB PAGE HERE,
THE BRAIN BLOG.
YOU CAN SEE IT HERE.
CONTACT THE BRAIN PROGRAM CENTER
TO SEE IF RFA IS STILL ACTIVE
WHAT APPLICATIONS TO FUND THIS
YEAR, WE'LL BE CONTINUING TO
FOCUS ON BRAIN PRIORITY AREAS,
INCLUDING THE TRAINING OF A
DIVERSE COHORT OF NEXT
GENERATION LEADERS.
WE'LL BE ASKING IS THE PROJECT
TRULY UNIQUE TO BRAIN, NOT
LIKELY TO BE SUPPORTED ANY WHERE
ELSE, INCLUDES TRANSFORMATIVE
PROJECTS AND BRAIN BEHAVIOR
QUANTIFICATION AND SIN
CO-NIGHSATION PROJECT.
DOES IT PROVIDE PORTFOLIO
BALANCE OR ADDRESS A GAP AREA?
DOES IT PROVIDE GEOGRAPHIC OR
INSTITUTIONAL DIVERSITY?
IS THE AREA OF INQUIRY OR P.I.
THEMSELF AT RISK IF WE DON'T
MAKE THIS AWARD?
AND WE'RE COGNIZANT OF ESI AND
EARLY-STAGE INVESTIGATOR AND NEW
INVESTIGATOR STATUS.
WE'LL BE UPDATING THE BUDGET
WEBSITE AS THINGS CHANGE, AS
THINGS EVOLVE, WE ENCOURAGE
PEOPLE AGAIN TO CONTACT OUR
PROGRAM STAFF WITH QUESTIONS.
THIS IS WHERE WE ARE WITH THIS.
I'M SURE THERE'S GOING TO BE
QUESTIONS AFTER I'M DONE AND I'M
HAPPY TO TAKE YOUR QUESTIONS AT
THAT TIME.
OKAY.
LET'S TALK ABOUT SOME COOL
THINGS GOING ON.
LET'S SET THE BUDGET CLOUD ASIDE
FOR A MOMENT.
WE'RE CELEBRATING SUCH AS WE ARE
10 YEARS OF INNOVATION FUNDED BY
THE BRAIN INITIATIVE.
WE'RE DOING A NUMBER OF THINGS
TO HELP, AGAIN, GET THE WORD
OUT.
ONE OF THOSE THINGS IS THROUGH
EACH OF THE INDIVIDUAL TEN I.C.
DIRECTORS BLOGS, WE'VE ASKED
EACH OF THEM TO GIVE THEIR
PERSPECTIVE ON HOW BRAIN HAS
FURTHERED THEIR MISSION AND HOW
THEIR MISSION CONTRIBUTES TO THE
BRAIN INITIATIVE.
OF COURSE, WE SELECTED WALTER TO
LEAD THIS EFFORT IN TERMS OF HOW
THIS HAS IMPACTED NINDS AND
NEUROSCIENCE MORE GENERALLY.
GEORGE KOOB FROM NIAAA PUBLISH
THE HIS -- PUBLISHED HIS
THOUGHTS, EIGHT MORE COMING
BETWEEN NOW AND LATE MAY, STAY
TUNED FOR THAT.
WE'RE ALSO POSTING THESE
PERSPECTIVES ON THE BRAIN
WEBSITE.
VERY EXCITED ABOUT THE TENTH
ANNUAL BRAIN INITIATIVE
CONFERENCE, HYBRID EVENT JUNE
17-JUNE 18.
WITH EARLY CAREER EVENT ON THE
EVENING OF JUNE 16.
THIS WILL BE A FORUM FOR SHARING
EXCITING DEVELOPMENTS,
DISCUSSING POTENTIAL NEW
DIRECTIONS IN COLLABORATIONS, ET
CETERA.
IT WILL TAKE PLACE IN PERSON AT
THE BETHESDA NORTH MARRIOTT
HOTEL.
WE HAVE SOME TERRIFIC PLENARY
SESSIONS COMING FOR YOU.
DR. LIQUN LUO WILL GIVE THE
FIRST ON DECONSTRUCTING THE
SEROTONIN SYSTEM IN THE MOUSE
BRAIN.
WE'LL HAVE A PANEL DISCUSSION ON
LATE MONDAY AFTERNOON,
REFLECTING ON WHAT BRAIN HAS
ACCOMPLISHED, WHERE IT IS GOING
IN THE FUTURE.
GUESTS WILL BE DR. BARGMANN, DR.
CHANG, FRANCIS COLLINS WHO YOU
ALL KNOW, FORMER DIRECTOR OF
NIH, CAROLINE MONTOJO, AND BILL
NEWSOM FROM STANFORD, LOOKING
FORWARD TO A FUN CONVERSATION
THERE.
TUESDAY MORNING DR. GRADINARU
FROM CAL TECH WILL TALK ABOUT
THE BLOOD-BRAIN BARRIER, WHETHER
FRIEND OR FOE.
PLEASE REGISTER, VIRTUALLY AND
IN PERSON.
ANYBODY IS FREE TO ATTEND.
IT IS OPEN TO THE PUBLIC.
WE V. DEVELOP A WORKSHOP
EXPLORING THE CHALLENGES.
THERE ARE GAPS IN OUR ABILITY TO
DEVELOP CAUSAL EXPLANATIONS IN
HUMAN NEUROSCIENCE.
EXISTING DATASETS ARE BETTER FOR
IDENTIFYING ASSOCIATIONS, SEEKS
TO EXPLORE CHALLENGES AND
OPPORTUNITIES ASSOCIATED WITH
MULTI-DISCIPLINARY AND
COORDINATED EFFORTS TO
UNDERSTAND RELATIONSHIP BETWEEN
FUNDAMENTAL BRAIN FUNCTION AND
HUMAN BEHAVIOR THROUGH NEURAL
STIMULATION AND RECORDING.
THIS DOVETAILS WITH A VERY
ROBUST PROGRAM IN "BRAIN" THAT
FALLS UNDER THE CATEGORY OF
RESEARCH OPPORTUNITY IN HUMANS.
WE HAVE REQUEST FOR INFORMATION
OUT LIVE RIGHT NOW, FOLKS CAN
GIVE THOUGHTS AND OPINIONS ABOUT
WHERE THE FIELD IS AND WHERE
THEY THINK IT SHOULD BE GOING.
WE HAVE A TERRIFIC EXTERNAL
COMMITTEE ADVISING THE STAFF AND
PUTTING TOGETHER THIS EXCITING
MEETING.
YOU CAN USE QR CODES TO GET MORE
INFORMATION.
OKAY.
SO IN TERMS OF SCIENTIFIC
UPDATES, I THOUGHT I'D TAKE THIS
OPPORTUNITY TO TELL YOU A BIT
ABOUT, SINCE I MET WITH YOU LAST
YEAR, ABOUT THE BIG CONSORTIA
THAT BRAIN HAS BEEN STANDING UP
OVER THE PAST FEW YEARS.
AND I HOPE YOU CAN SEE THAT
WE'RE CONTRIBUTING TO THE
NEUROSCIENCE ENTERPRISE IN A
UNIQUE WAY, REALLY TO ENABLE ALL
THE TEN CONTRIBUTING BRAIN
I.C.s IN THEIR MISSIONS, I
THINK HOPEFULLY YOU CAN SEE HOW
THIS WILL CONTRIBUTE TO THE
MISSION DIRECTLY.
I WANT TO TOUCH ON THE BRAIN
INITIATIVE CELL CENSUS PROJECT,
AMAZING IN MY OPINION.
IT STARTED IN 2014, THE VERY
BEGINNING OF THE BRAIN
INITIATIVE, AS A PILOT PROJECT
WITH THE IDEA THAT IN ORDER TO
UNDERSTAND HOW THE BRAIN WORKS
YOU NEED TO HAVE A BETTER
UNDERSTANDING OF THE PIECES AND
PARTS THAT COMPRISE THE BRAIN,
ULTIMATELY THE HUMAN BRAIN.
THIS IS BACK IN 2014.
SINGLE CELL SEQUENCING WAS
STARTING TO TAKE OFF, ALSO
RECOGNITION THAT CELLULAR
COMPLEXITY AND THEIR FUNCTION IS
MORE THAN JUST ABOUT THEIR
TRANSCRIPTOMES.
SO, A DECISION WAS MADE TO START
THESE TEN PILOT PROJECTS TO
DEVELOP AND VALIDATE SCALABLE
TECHNOLOGIES THAT WOULD ALLOW A
MULTI-MODAL ANALYSIS OF THE
PROPERTIES AND CONNECTIONS THAT
CELLS AND THE BRAIN MAKE ACROSS
MULTIPLE SPECIES AND OVER THE
LIFETIME OF THE ANIMAL.
THIS WAS THE PILOT PHASE,
SO-CALLED CELL SEVEN CUSS
CONSORTIUM.
THIS SCALED UP IN 2017 THROUGH
2022, INTO THE BRAIN INITIATIVE
CELL CENSUS NETWORK TO CLASSIFY
BRAIN CELL TYPES BASED ON
INTEGRATED ANALYSIS OF THE
MOLECULAR, ANATOMICAL,
PHYSIOLOGIC PROPERTIES.
THIS IN TURN GAVE WAY IN 2022
INTO THE BRAIN INITIATIVE CELL
ATLAS NETWORK NOW SETTING SIGNS
ON BIG BRAINS.
THE MANTRA HAS BEEN THINK BIG,
SMART SMALL, SCALE FAST.
I'LL WALK YOU THROUGH THE
PROGRESS.
WALTER IN THE LAST COUNCIL
MEETING GAVE A BRIEF OVERVIEW.
I WANT TO TAKE A DEEPER DIVE
JUST TO GIVE YOU A FLAVOR OF HOW
THIS PROJECT EVOLVED AND HOW
IT'S INFORMING OUR OTHER MAJOR
MAPPING PROJECTS.
FIRST SCALEUP PHASE WAS IN THE
BRAIN INITIATIVE CELL CENSUS
NETWORK THAT RAN FROM 2017-2022,
JUST CONCLUDING, STILL WRAPPING
UP.
THIS LED TO A REMARKABLE SET OF
PUBLICATIONS, STARTING WITH A
PILOT PROJECT LOOKING AT THE
DIVERSITY OF CELL TIMES, PRIMARY
MOTOR CORTEX.
THIS EFFORT WAS PUBLISHED AS A
SET OF 17 ARTICLES IN "NATURE,"
PLUS TEN IN "NATURE" SISTER
JOURNALS IN OCTOBER OF 2021
FOLLOWED BY THIS PAST DISEASE 10
ARTICLES IN "NATURE," NONE
FUNDED BY "BRAIN."
ON THE WHOLE MOUSE BRAIN ATLAS,
A MONUMENTAL ACHIEVEMENT.
I'LL GO THROUGH THAT IN A
SECOND.
EARLIER LAST FALL OCTOBER 2023,
21 ARTICLES IN SCIENCE AND
SCIENCE SISTER JOURNALS
DESCRIBING THE FIRST
COMPREHENSIVE DRAFT HUMAN AND
NON-HUMAN PRIMATE BRAIN ATLASES.
LET ME WALK YOU THROUGH THE
PROGRESSION HERE.
AGAIN, INITIALLY, IN THE BICCM,
I PRIVILEGED TO BE A MEMBER OF
THAT, THE CONCERN WAS DID WE
HAVE TOOLS TO PUT THIS PICTURE
TOGETHER SO WE DECIDED TO FOCUS
ON A TINY PIECE OF THE BRAIN,
WHICH WAS THE PRIMARY MOTOR
CORTEX IN MICE, NON-HUMAN
PRIMATE, AND HUMANS.
SO WE CREATED A MULTI-MODAL
CENSUS, ATLAS OF PRIMARY MOTOR
CORTEX ACROSS MULTIPLE SPECIES.
THIS REPRESENTED A TRIUMPH OF
TEAM SCIENCE, REPRESENTED THE
WORK OF 250 RESEARCHERS, FROM
ALMOST 90 AFFILIATIONS, 45
INSTITUTIONS ACROSS THREE
CONTINENTS, WE LEARNED HOW TO DO
AND PROMOTE BIG SCIENCE, SETTING
THE STAGE FOR LARGER
COMPREHENSIVE BRAIN CELL ATLASES
THAT I'LL TELL YOU ABOUT IN A
MOMENT.
SO, THIS WAS FOLLOWED EVENTUALLY
BY THE PUBLICATION OF THE SERIES
OF PAPERS DESCRIBING THE MOUSE
BRAIN CELL ATLAS, WHERE OVER 32
MILLION CELLS ACROSS THE ADULT
MOUSE BRAIN WERE CHARACTERIZED
USING COMBINATION OF HIGH
RESOLUTION SINGLE-CELL
TECHNIQUES.
ONE CAN CLASSIFY THESE USING
VARIOUS STATISTICAL METHODS TO
FIND UP TO 5300 DISTINCT WHAT
YOU MIGHT CALL CELL TYPES, OF
BOTH NON-NEURONAL AND --
NEURONAL AND NON-NEURONAL TYPES,
REVEALING ORGANIZATIONAL
PRINCIPLES, SERVING AS FRAMEWORK
TO MOVE FORWARD AND
FUNCTIONALIZE TO UNDERSTAND HOW
THE CELLS CONTRIBUTE TO NEURAL
CIRCUIT FUNCTION OF BOTH HEALTH
AND DISEASE.
A FEW TAKEAWAYS, A VAST COMPLEX
ACTIVE CELL TIMES, PERHAPS NOT A
SURPRISE GIVEN ANCIENT CHARACTER
OF THE SUBCORTICAL REGIONS AND
THE SOMEWHAT REPEATING NATURE OF
COMMON MOTIFS ACROSS THE CORTEX.
THROUGH THIS EFFORT WAS
DEVELOPED THESE REMARKABLE
SPATIAL TRANSCRIPTOMIC
TECHNOLOGIES TO SERVED TO PLACE
WHERE IN THE BRAIN THE CELL
TYPES EXIST BUT ALSO SERVE TO
VALIDATE ACTUAL EXISTENCE OF
THESE MAINLY TRANSCRIPTOMICALLY
DEFINED CELL TYPES AND USING
EPIGENETIC PROFILING AT THE
SINGLE CELL LEVEL ALLOWED US TO
UNDERSTAND THE GENETIC AND
EPIGENETIC PROGRAMS THAT SPECIFY
CELLULAR IDENTITY IN THE BRAIN
AND HOW CELL TYPES CAME TO BE
THROUGH EVOLUTION AS WELL AS
DEVELOPMENT.
SO THIS PROVIDES GROUND TRUTH
INFORMATION FOR FUNCTIONAL
STUDIES THAT HOPEFULLY WILL BE
ONGOING USING THIS INFORMATION.
NOW, TO THE BIG BRAINS, THE
DRAFT HUMAN, NON-HUMAN PRIMATE
BRAIN ATLAS WAS PUBLISHED,
MAPPED UNPRECEDENTED
COMPLEXITIES ACROSS SPACE,
SPECIES, AND TIME.
IT PAVES THE ROAD TO GREATER
UNDERSTANDING OF THE HUMAN BRAIN
AT THE CELLULAR LEVEL IN BOTH
HEALTH AND DISEASE.
SO THIS USHERS IN A NEW ERA OF
HUMAN BRAIN RESEARCH ACROSS
SPACE.
WE CAN ACTUALLY IDENTIFY WHERE
IN SPACE THESE DIFFERENT CELL
TYPES EXIST.
ACROSS SPECIES, THIS IS REALLY
COOL.
ANALYSIS CONDUCTED ACROSS
PRIMATE SPECIES INCLUDING
NON-HUMAN PRIMATE AND HUMANS,
NOT SURPRISINGLY IF YOU LOOK AT
DIVERSITY OF CELL TIMES AND
SIMILARITY ACROSS SPECIES, ARE
SIMILAR BETWEEN CHIMPANZEES AND
US.
IF YOU LOOK AT THE GENE SHOWING
THE MOST DIFFERENCES BETWEEN
HUMANS AND, SAY, NON-HUMAN
PRIMATE, THEY TEND TO CLUSTER IN
THESE AREAS OF HUMAN ACCELERATED
EVOLUTION, AND THEY INCLUDE NOT
TOO SURPRISINGLY GENES ENCODING
COMPONENTS OF THE SYNAPTIC
SIGNALING MACHINERY.
SO THERE WILL BE A LOT TO UNPACK
IN TERMS OF WHAT'S DRIVING
CHANGES THROUGH EVOLUTION AND
WHAT MAKES US UNIQUELY HUMAN
COMPARED TO OUR CLOSE RELATIVES
IN THE PRIMATE LINEAGE.
STUDIES PAVE THE WAY FOR LOOKING
AT CELL TYPES AS THEY DEVELOP
ACROSS DEVELOPMENTAL TIME, AS
THEY CHANGE OVER AGING.
THIS WILL BE REALLY IMPORTANT
FOR UNDERSTANDING
NEURODEVELOPMENTAL DISORDERS AS
WELL AS FOR NEURODEGENERATIVE
DISORDERS, BOTH ARE PLAGUING OUR
SOCIETY TODAY.
WE'RE VERY EXCITED ABOUT THESE
STUDIES AND IT SETS THE STAGE
FOR THE BRAIN INITIATIVE CELL
ATLAS NETWORK TO PROVIDE
COMPREHENSIVE BRAIN CELL ATLASES
OF HUMAN AND NON-HUMAN PRIMATE
BRAINS, AN EFFORT JUST GETTING
GOING.
THIS LEADS ME TO BRIEFLY FRAME
THIS IN THE CONTEXT OF THE THREE
BRAIN 2.0 TRANSFORMATIVE
PROJECTS, THE BRAIN INITIATIVE
CELL ATLAS NETWORK WHICH IS
GOING TO SCALE UP TO PUT AN
EMPHASIS ON HUMAN AND NON-HUMAN
PRIMATE BRAINS.
THE BRAIN CONNECTS PROGRAM
LOOKING TO DEVELOP TECHNOLOGIES
FOR WRITING DIAGRAMS AND
ARMAMENTARIUM FOR PRECISION
BRAIN CELL ACCESS TO BUILD A
TOOL KIT TO ACCESS BRAIN CELL
TYPES BASED ON MOLECULAR
IDENTITIES.
LET ME GO THROUGH THIS QUICKLY.
THIS IS A NATURAL SEGUE INTO THE
BRAIN INITIATIVE CELL ATLAS
NETWORK, BICAN, BUILD ON
FOUNDATION OF BICCN, THE IDEA TO
MOVE BEYOND HAVING DATA TO BUILD
NEW KNOWLEDGE BASES FOR
NEUROSCIENCE, WITH ADVANCES IN
ARTIFICIAL INTELLIGENCE
TECHNOLOGIES, I THINK WE SHOULD
BE ABLE TO USE THIS AS A
RESOURCE WE RESEARCHERS CAN BE
STUDYING CELL TYPES AND
PROPERTIES IN THEIR OWN STUDIES,
OWN LABORATORIES, TO USE THIS AS
A RESOURCE TO BETTER UNDERSTAND
HOW TO APPROACH THEIR PROBLEMS.
ALREADY THIS IS PROVIDING A
RESOURCE FOR I.C.-SPECIFIC
MISSIONS IN NIDA, NIDA STEPPED
UP THE SCORCH INITIATIVE WHICH
IS USING SINGLE CELL APPROACHES
TO UNDERSTAND WHAT CHANGES IN
THE BRAIN IN MODELS OF ADDICTION
AND HIV.
THERE'S BEEN A HUGE EFFORT
ONGOING IN NATIONAL INSTITUTE ON
AGING LOOKING AT THE CELLULAR
CHANGES ONGOING AT DIFFERENT
STAGES OF PROGRESSION AND
ALZHEIMER'S AND RELATED
DISEASES, AND THIS IS JUST AN
EXAMPLE OF A PROJECT LED BY
ALLEN INSTITUTE AND UNIVERSITY
OF WASHINGTON TO LOOK AT A
COHORT OF INDIVIDUALS WHO DIED
FOLLOWING ALZHEIMER'S DIAGNOSIS
BUT AT DIFFERENT STAGES OF THE
DISEASE.
THIS IS VERY EXCITING WORK TO BE
CONSIDERING IN THE FUTURE.
WE'RE HOLDING WORKSHOPS TO
FIGURE OUT HOW TO BETTER
LEVERAGE THIS INFORMATION TO
TURN IT INTO A KEY RESOURCE BY
IDENTIFYING OPPORTUNITIES AND
CHALLENGES IN FRONT OF US.
LET ME TAKE A MOMENT TO DESCRIBE
THE BRAIN CONNECT ACROSS SCALES
PROJECT.
WE RECENTLY ISSUED 11 GRANTS
SUPPORTING RESEARCH TEAMS AND
COLLABORATORS ACROSS 40
UNIVERSITIES AND RESEARCH
INSTITUTIONS.
OVER THE NEXT FIVE YEARS THEIR
GOAL WILL BE TO LEVERAGE
TECHNOLOGIES TO IMAGE AND
ANALYZE BRAIN CONNECTIVITY ONE
WITH UNPARALLELED SPEED.
THEY WILL BE ABLE TO APPLY THIS
TO WHOLE BRAINS.
FOR THE MOMENT PROJECTS WILL
DEVELOP MAPPING TECHNOLOGIES
COVERING THREE CORE AREAS.
THE FIRST IS WORK HORSE
ELECTRONIC MICROSCOPY, A LOT
PIONEERED THROUGH THE MICRONS
EXPLORER PROJECT FUNDED BY
IARPA.
ANOTHER AREA WILL FOCUS ON USING
MOLECULAR SEQUENCING TOOLS TO
GIVE US GREATER THROUGHPUT BUT
ALSO INFORMATION ABOUT MOLECULAR
IDENTITY.
FINALLY SOME NOVEL OPTICAL
TECHNOLOGIES TO ALLOW FOR LONG
DISTANCE HIGHER RESOLUTION
MAPPING, HUMANS AND NON-HUMAN
PRIMATES.
LET ME GIVE YOU BACKGROUND.
ALONG THE IDEA OF THINK BIG,
START SMALL, SCALE FAST, SIMILAR
TO THE HUMAN GENOME PROJECT
WHERE SEQUENCING MODELS SYSTEMS
OF SMALLER GENOMES HELPED
DEVELOPED TOOLS REQUIRED TO
TACKLE LARGER MORE COMPLEX HUMAN
GENOME, THE FLY CONNECT
CONNECTOME IS THE FORERUNNER.
THE FLYWIRE GROUP REVEALED A MAP
OF THE FRUIT FLY BRAIN.
DROSOPHILA CONNECTOME IS
ALLOWING FOLKS TO STUDY CIRCUIT
BASES OF BEHAVIOR AND BETTER
FRAME THEIR HYPOTHESES TO
FALSIFY OR TRUTHIPHY THEM, A LOT
OF GREAT TECHNOLOGIES INCLUDING
MACHINE LEARNING FOR
SEGMENTATION AND ANALYSIS,
INTERESTINGLY TO USE THIS AS
OPEN SOURCE TOOL THAT ALLOWS
PEOPLE TO COME IN, IN A CITIZEN
SCIENCE KIND OF WAY TO ASSIST IN
PROOF READING, THE BOTTLENECK
FOR THIS PROCESS.
WHAT'S COOL IS PEOPLE ARE
ALREADY REFERRING TO THE WORK IN
THE BEFORE CONNECTOME VERSUS
AFTER CONNECTOME ERAS BECAUSE
THEY CAN USE THIS INFORMATION TO
FRAME AND BETTER UNDERSTAND
HYPOTHESES THEIR TRYING TO TEST.
THIS IS A DROSOPHILA TINY BRAIN.
JUST RECENTLY LAST WEEK JEFF
LITMAN'S GROUP PUBLISHED THIS
REPRESENTING ONE CUBIC
MILLIMETER OF HUMAN TEMPORAL
CORTEX THAT BEAUTIFULLY SPANS
ALL SIX CORTICAL LAYERS,
OCCUPIES OVER A PETABYTE OF
DATA.
SO A HOW TERABYTES.
57,000 CELLS, 230 MILLIMETERS OF
BLOOD VESSELS, 150 MILLION
SYNAPSES.
THE VIEWS ARE STAGGERING.
YOU CAN LEARN A LOT BY LOOKING,
TO PARAPHRASE YOGA BEER A, CAN
SEE PROPERTIES OF INDIVIDUAL
CELLS, SYNAPSES WITH EACH OTHER,
AND AGAIN DEVELOPING
METHODOLOGIES TO CAPTURE,
ANNOTATE, RECONSTRUCT, AND
ANALYZE THIS INFORMATION.
THIS WAS A CLOSE COLLABORATION
BETWEEN THE LICHTMAN LAB AT
HARVARD AND THE JAMES GROUP AT
GOOGLE RESEARCH, PART OF THE
CONNECTS PROGRAM, AMONG THOSE 11
GRANTS I MENTIONED.
WE'RE HOPEFUL THAT THIS CAN BE
SCALED UP.
THIS IS A CUBIC MILLIMETER OF
HUMAN CORTEX, AN ENTIRE MOUSE
RAIN IS, WE HAVE THREE ORDERS TO
SCALE UP.
GIVEN THE PROGRESS, I HAVE HIGH
HOPES WE'LL GET THERE IN THE
NEXT FEW YEARS.
>> JOHN, TIM HAD A QUESTION.
>> OKAY.
TIM, HOLD ON TILL I GET DONE.
>> I WAS GOING TO WAIT.
>> DIDN'T KNOW.
>> OKAY, YOU CAN WAIT?
>> ABSOLUTELY.
>> HOLD YOUR HORSES, MAN, I'LL
GET TO YOU.
>> THE THIRD AND FINAL PROJECT
IS THE ARMAMENTARIUM FOR
PRECISION BRAIN CELL AXIS TO
LEVERAGE INFORMATION OUT OF THE
CELL CENSUS PROJECT TO TEST IN A
MORE PRECISE WAY HIGH --
HYPOTHESES, CONTRIBUTING TO
NEUROCIRCUIT FUNCTION, I HOPE
YOU CAN SEE THEY WORK
SYNERGISTICALLY TOGETHER.
THE IDEA HERE IS TO PUSH THIS
PROJECT ACROSS THREE OVERLAPPING
AND MUTUALLY REINFORCING
DOMAINS.
ONE TO DEVELOP BETTER ACCESS
TOOLS TO CELL TYPES ACROSS
MULTIPLE SPECIES AND BRAINS.
TO DEVELOP BETTER MOLECULAR
PAYLOADS, OPTOGENETIC,
CHEMOGENETIC OR GENE EDITORS,
AND VERY IMPORTANTLY TO
DISSEMINATE TOOLS OUT,
RESEARCHERS CAN USE THEM TO
SUPPORT WHAT'S REALLY A GREAT
OPPORTUNITY IN OUR CIRCUITS
PORTFOLIO, ALSO ACROSS THE
ENTIRE DOMAIN OF NEUROSCIENCE.
WE'VE ISSUES A SERIES OF U01
PILOT PROJECTS TO DEVELOP
EFFECTIVE ACCESS TOOLS, SPILLING
OUT OF THE CELL CENSUS PROJECT.
WE'RE STARTING TO STAND UP UM1
LARGE TEAM PROJECTS TO DEVELOP
MORE EFFECTIVE PAYLOADS, AND
DISSEMINATION IS IMPORTANT,
STANDING UP WAYS TO GET THESE
REGIONS OUT FOR THE BENEFIT OF
ALL.
THIS IS JUST A QUICK SUMMARY OF
THE U01 GRANTS WE'RE FUNDING
CURRENTLY.
FOCUSING SO FAR STILL ONLY ON
ADENO-ASSOCIATED VIRUS, STILL
THE WORKHORSE IN THE GENE
THERAPY WORLD, NO ACCIDENT WHY
WE'RE IN THAT SPACE.
FOCUSING ON CAPSID DESIGN AS
WELL AS GENE REGULATORY
ELEMENTS.
SO FAR THE GROUP HAS BEEN
REMARKABLY PRODUCTIVE PUBLISHING
COOL PAPERS, AND I UNDERSTAND
THERE'S A PACKAGE BEING PUT
TOGETHER AND WE'LL HEAR MORE
ABOUT THAT WHEN IT'S PUBLISHED.
WE HAVE THE PENDING MOLECULAR
PAYLOADS, UM1 COMING UP.
IN TERMS OF DISSEMINATION WE'VE
SET UP AN INTERESTING EXPERIMENT
TO TEAM UP THE U01 DEVELOPERS
TOGETHER WITH MINORITY-SERVING
INSTITUTIONS TO NOT ONLY
DISTRIBUTE THESE VECTORS, NEW
VECTORS FOR OTHERS TO USE, BUT
ALSO TO BE INVOLVED IN THE
RESEARCH AND DEVELOPMENT AND
OPTIMIZATION OF THESE REAGENTS.
SO FAR WE HAVE A NICE
COLLABORATION BETWEEN ANDY
STEELE'S GROUP AT CAL POLY
POMONA, WITH VIVIAN A'S GROUP AT
CAL TECH, AND ALSO ONE BETWEEN
THE GROUP AT THE BROAD INSTITUTE
AND THE LAB AT U.C. IRVINE,
LACKING UP TO STANDING UP MORE
AS WE MOVE FORWARD.
THERE ARE VARIOUS WAYS OF
GETTING REAGENTS OUT.
BRAIN INITIATIVE HAS ITS OWN
PAGE ON ADDGENE, A GREAT WAY TO
GET THESE OUT IN THE REAL WORLD,
AND SUPPORTING A NUMBER OF VIRAL
CORES AROUND THE COUNTRY.
WE'RE EXCITED ABOUT THAT.
WITH THAT I WILL JUST END BY
JUST REMINDING YOU, YOU CAN STAY
UP TO DATE WITH WHAT WE'RE DOING
AT BRAIN THROUGH THESE VARIOUS
CHANNELS.
IF YOU SUBSCRIBE TO THE BRAIN
BLOG, WE PROMISE NOT TO SPAM YOU
TOO HEAVILY BUT IT'S IMPORTANT
WITH THIS TOUGH FUNDING
ENVIRONMENT FOR PEOPLE TO STAY
UP TO DATE TO KNOW WHERE THE
BEST FUNDING OPPORTUNITIES WOULD
BE FOR THEM.
AND WITH THAT, I WILL STOP AND
TAKE TIM'S QUESTION.
>> FIRST, JOHN, CONGRATULATIONS,
MUST BE SATISFYING TO HELP STEER
A SUCCESSFUL PROGRAM.
QUESTIONS RELATED TO THE
PROGRESS ON CONNECTOMES, MIND
BLOWING IN MANY WAYS, BUT
THERE'S A BIG INFORMATION GAP
FOR SOMEONE LIKE ME AS A SYNAPSE
PERSON THAT HOW DO I INTERPRET
THESE, HOW WOULD I INTERPRET
THEM, WE KNOW FROM ALL SPECIES
STUDIES THE BEST WAY TO MODULATE
HOW WELL A SYNAPSE WORKS TO
GENERALLY DO GPCR SIGNALING,
THAT'S THE POTENT WAY YOU TURN A
SYNAPSE ON, MAKE IT BETTER, SHUT
IT OFF.
THIS IS A GAP, IT'S NOT IN ANY
OF OUR DATASETS YET.
HAVE YOU GUYS DISCUSSED WAYS, I
KNOW IT'S NOT A TRIVIAL PROBLEM,
WHY IT'S NOT DONE, BUT ARE YOU
THINKING HOW THAT'S GOING TO BE
TACKLED?
>> WELL, LOOK, THE PHYSICAL MAP,
RIGHT, THIS IS GOING TO BE
STATIC, WHAT I CONSIDER
NECESSARY BUT NOT SUFFICIENT TO
UNDERSTAND HOW A SIGNAL WORKS IN
THE BRAIN.
SO, WHAT'S REALLY COOL BUT ALSO
KIND OF A LITTLE BIT
INTIMIDATING AND SCARY, THERE
HAVE BEEN SOME COOL PAPERS
COMING OUT OF C. ELEGANS SHOWING
MOST OF THE SIGNALING ISN'T
SYNAPTIC, JUST SO MUCH
NEUROMODULATORY SIGNALING GOING
ON THROUGH NEUROPEPTIDES, WHICH
CONNECT AT A DISTANCE.
THIS IS A NECESSARY STEP FOR US
TO START CHIPPING AWAY.
LIKE THE CELL CENSUS PROJECT
JUST BECAUSE YOU KNOW WHAT
GENES, WHAT RNA TRANSCRIPTS ARE
EXPRESSED DOESN'T TELL YOU WHAT
THE CELL IS DOING BUT IS A
NECESSARY COMPONENT.
>> I'M APPLAUDING WHERE YOU ARE
BUT I KNOW TO GO FURTHER WE'LL
NEED THESE OTHER LAYERS.
>> ABSOLUTELY.
ABSOLUTELY.
AND HOPEFULLY THIS WILL INSPIRE
OTHERS TO DIG IN AND FIND THOSE
OTHER WAYS TOO, YEP.
>> THANKS.
>> OTHER QUESTIONS FOR JOHN?
HANK?
>> YEAH, I REALLY ENJOYED THAT.
TALK ABOUT GAPS, WE'RE HAVING A
TREMENDOUS AMOUNT OF DATA BEING
GENERATED IN DIFFERENT WAYS THAT
PEOPLE WILL BE ABLE TO TAP INTO.
THE REALITY IS MOST SCIENTISTS
HAVE THEIR SORT OF DIFFICULTY
GETTING TO A NEW KIND OF
SCIENCE, AND SO I'M THINKING
ABOUT I DEAL WITH THIS ALL THE
TIME, THINKING ABOUT GENETICS,
HOW DO GENETICISTS DO FUNCTIONAL
GENETICS.
MAYBE A QUESTION FOR WALTER,
THINK ABOUT MANY NON-R01
PROGRAMS AROUND THE COUNTRY, HOW
DO WE EDUCATE PEOPLE TO USE
DATASETS BEGINNING TO EMERGE,
WHETHER ATLAS OR BRAIN CELLS,
EXPRESSION PATTERNS,
DISEASE-RELATED THINGS, WITHOUT
MUCH MONEY THEY COULD TAKE BRAIN
IT WILLENT AND PUT IT TOWARD
THIS BUT I DON'T KNOW IF WE'RE
CREATING EDUCATIONAL TRAINING
PROGRAMS TO ALLOW PEOPLE TO DO
THAT.
ARE WE MISSING AN OPPORTUNITY
THERE?
>> WELL, THERE'S AN OPPORTUNITY
THAT WE'RE TRYING TO GRAB ONTO,
ABSOLUTELY.
A COUPLE WAYS.
ONE IS I THINK AS THESE STUDIES
BECOME MORE COMMONPLACE THERE
WILL BE I HOPE BY SOME NATURE,
SOME KIND OF DEMOCRATIZATION.
AS AN EXAMPLE, ONE HUGE BENEFIT
OF HAVING THESE COMPREHENSIVE
CELL ATLASES IS THAT IF YOU WANT
TO UNDERSTAND THE CELL TYPES AND
PROPERTIES WITHIN YOUR AREA OF
INTEREST, YOU DON'T NEED TO
SEQUENCE THE SAME DATA.
IN FACT, THE CONSORTIUM HAS
SHOWN YOU CAN DO SOME FAIRLY
SHALLOW ANALYSIS AND THEN USE
THAT TO GO INTO THE BIGGER
DATASET TO ASK WHAT'S THERE.
YOU CAN IMPUTE AND INFER A LOT.
THAT'S ONE PART.
YOU'RE RIGHT, THE ISSUE IS HOW
DO YOU GET PEOPLE TO ACTUALLY
COME ON BOARD AND ADOPT THESE
THINGS.
BRAIN HAS A DISSEMINATION
PROGRAM, WE'RE DOING OUR BEST TO
SUPPORT VARIOUS PROGRAMS.
WE FUNDED SOME FOLKS LIKE JEFF
LICHTMAN TO LEARN HOW TO DO THE
STUFF.
WE HAVE OTHER COURSES AND
DISSEMINATION GROUPS THAT RUN
COURSES, COUPLE-WEEK WORKSHOPS
TO GET THESE THINGS OUT.
YOU'RE GOING TO SEE A CONCEPT
CLEARANCE I THINK FOR TRYING TO
FIGURE OUT A WAY TO ENCOURAGE
THESE TOOLS TO BE ADOPTED BY
INVESTIGATORS AND
RESOURCE-LIMITED INSTITUTIONS.
CHIPPING AWAY PIECE BY PIECE, I
MENTIONED THIS EXPERIMENT THAT
WE'RE DOING BY TEAMING UP OUR
ARMAMENTARIUM TOOL DEVELOPERS
TOGETHER WITH MINORITY-SERVING
INSTITUTIONS, NOT JUST TO HAVE
THEM GRIND UP FOR PEOPLE BUT
PARTAKE IN RESEARCH AND
DEVELOPMENT.
EVERY LITTLE BIT COUNTS.
WE'RE GOING TO WIN THIS WAR ONE
PIECE AT A TIME.
THESE ARE ISSUES THAT WE'RE
CONCERNED ABOUT, IF WE CAN'T GET
THESE RESOURCES IN THE PEOPLE'S
HANDS YOU HAVE TO ASK WHAT GOOD
ARE THEY, RIGHT?
HOPEFULLY SLOWLY BUT SURELY
WE'LL START GETTING THERE.
IT CAN'T COME SOON ENOUGH OF
COURSE.
WE'RE ALREADY STARTING TO SEE
VARIOUS I.C.s TAKE THE BALL
AND START RUNNING, ACTUALLY
STARTING TO PUT THE ADVANCES
THAT WE'VE DEVELOPED IN "BRAIN"
OVER A FEW SHORT YEARS INTO
ONGOING PROJECTS.
SOME OF THESE THINGS IN LESS FAN
FIVE YEARS ARE ALREADY SEEING
TOOLS POP UP WITHIN THESE MAJOR
INITIATIVES WITHIN OTHER
I.C.s.
SO WE'RE JUST HOPING TO
ACCELERATE THE WHOLE PROCESS,
HOPEFULLY WE'LL BE PULLING MORE
PEOPLE ALONG WITH THIS.
>> WHERE CAN WE FIND THESE
COURSES YOU MENTIONED, JOHN?
>> JUST GO TO BRAIN.GOV.
WE HAVE THE SNAZZY NEW WEBSITE.
IF YOU CAN'T FIND WHAT YOU'RE
LOOKING FOR THERE, GINA, JUST
CALL ME.
>> FLORIAN?
>> THANKS, JOHN.
THAT WAS PHENOMENAL.
I'M SO IMPRESSED.
AND REALLY EXCITED ABOUT THIS
NEXT GENERATION OF AAV SECTORS
COMING OUT OF THIS CONSORTIUM
WORK.
AS A CHILD NEUROLOGIST PUTTING
GENES BACK AND DELIVERING THEM
TO CHILDREN THIS IS SO
IMPORTANT.
ONE THING THAT'S A CONSTANT
WORRY TO ME IS THESE DEFECTIVE
GENES HAVE ALREADY BEEN AT WORK
FOR MANY YEARS, IN THESE
CHILDREN.
THERE'S MALADAPTATION THAT'S
OCCURRED, AND ARE WE REALLY
DELIVERING THIS IN THE RIGHT
WAY, IN THE RIGHT FORM.
HOW MUCH OF YOUR INITIATIVE IS
ALSO ADDRESSING EARLY BRAIN
DEVELOPMENT AND PLASTICITY?
I THINK THAT WOULD BE SO
IMPORTANT TO UNDERSTAND HOW TO
REALIZE THESE THERAPIES.
>> RIGHT, EARLY YEARS OF THE
BRAIN INITIATIVE, THE FOCUS WAS
DECIDEDLY NOT ON EARLIER
DEVELOPMENTAL ISSUES, JUST TO
MAKE SURE THAT THE EFFORT TO
BOIL EVERY OCEAN WOULD WIND UP
BIOLOGY NONE.
WE'RE TURNING OUR ATTENTION MORE
TO DEVELOPMENT AND LIFESPAN, A
BIG PIECE OF THE CURRENT BICAM
PROJECTS ARE FOCUSED ON HUMAN
DEVELOPMENT, SO PRENATAL
DEVELOPMENT.
AND THE BICCN IS WRAPPING UP AND
PUTTING TOGETHER I UNDERSTAND
ANOTHER PACKAGE, DEVELOPMENT,
FOCUSING ON THE MOUSE.
THESE ARE CRITICALLY IMPORTANT.
AS YOU CAN APPRECIATE, THE
BLOOD-BRAIN BARRIER, AS VIVIAN'S
GROUP HAS SHOWN, SHE WILL TALK
ABOUT IN HER PLENARY LECTURE IN
A COUPLE WEEKS, THE BLOOD-BRAIN
BARRIER IS A FRIEND BUT ALSO A
FOE IN TERMS OF GETTING THINGS
ACROSS, DRUGS OR -- AND
INCLUDING VIRAL VECTORS AND
PAYLOADS.
THE BLOOD-BRAIN BARRIER ISN'T
STATIC.
YOUR BBB IS NOT THE ONE YOU WERE
BORN WITH.
THERE ARE MOLECULAR CHANGES.
WE DO NEED TO BE CONSIDERING
WHAT HAPPENS OVER THE LIFESPAN
IF WE TRULY WANT TO COME UP WITH
INNOVATIVE PRECISION AND
SPECIALIZED TREATMENT.
SO THIS IS I THINK THIS WILL BE
REALLY A GREAT OPPORTUNITY FOR
US TO DIVE INTO.
YOU KNOW, THE INFORMATION IS
THERE FOR US TO GET AND LEVERAGE
.
>> OTHER QUESTIONS FOR JOHN?
HEARING NONE, JOHN, THANK YOU
VERY MUCH.
GOOD UPDATE.
>> THANK YOU ALL.
LOOKING FORWARD TO SEEING YOU
NEXT TIME.
>> TAKE CARE.
OKAY.
SO WE HAD SCHEDULED A BREAK BUT
I BELIEVE WE COULD PROBABLY JUST
PUSH THROUGH.
WE HAVE ONE FINAL ITEM, OUR
CONCEPT CLEARANCE, MOST ARE
REISSUES.
LET'S GO FOR IT.
>> I JUST WANT TO SAY EVERYONE,
PLEASE REFRESH THE ECB.
AND ALSO THERE WAS A FLASH DRIVE
THAT WAS FOUND IN THE WOMAN'S
BATHROOM, SO IF YOU ARE LOOKING
FOR A FLASH DRIVE I HAVE IT.
SOMEONE GAVE IT TO ME.
I DID NOT ...
[LAUGHTER]
TO BE CLEAR.
>> VERY GOOD.
OKAY, SO, YEAH.
ARE WE READY?
OKAY.
SO, WE ALWAYS MAKE YOU AWARE OF
THE CONCEPTS, WHAT CONCEPTS ARE,
POTENTIALLY NEW PROGRAMS NOW,
WHEN WE PROPOSE A CONCEPT
DOESN'T NECESSARILY MEAN WE
COMPLETE A CONCEPT BUT WE DO
MAKE THE COUNCIL AWARE.
IN THE PAST WE'VE GOTTEN IN THE
HABIT OF REALLY NOT GOING INTO
DETAILED PRESENTATIONS.
WE MADE THE MATERIAL AVAILABLE,
THE BRIEF WRITEUPS IN THE ECB
AND FOR THE REISSUE, WHICH WE
COULD HAVE DISCUSSED IN SOME
DETAIL IN THE PAST, WE PUT THESE
UP.
NOW, WHAT WE'RE HAPPY TO ANSWER
ANY QUESTIONS, WE DON'T NEED TO
RUSH IT.
BUT WE'RE NOT GOING TO
INDIVIDUALLY GO THROUGH EACH ONE
OF THESE.
SO WHAT I'M GOING TO DO IS DROP
INTO A MOMENT OF SILENCE AND
HAVE EVERYONE LOOK AT THE LIST.
AND IF ANYONE HAS ANY QUESTIONS,
WE'LL HAVE THE APPROPRIATE
INDIVIDUAL RESPOND.
OKAY.
HEARING NO QUESTIONS, WHAT I
WILL ASK FOR THOUGH IS A MOTION
TO MOVE FORWARD IF WE CHOOSE ON
THESE REISSUED CONCEPTS.
SO MOVED.
AND A SECOND.
OKAY.
HERE WE GO AGAIN.
TIM?
>> OKAY, EVERYONE.
GO TO THE VOTING TAB.
IT'S THE FIRST TAB ON THE LEFT.
OF THE.
BOB BROWN, DO YOU SEE IT?
>> WE'RE GOOD.
>> AWESOME.
>> AND I PROPOSE, LOUISE, IF IF
YOU HIT THEEL THAT SAYS YES OR
NO, THE GRAY-OUT GOES INTO.
>> HIT SAVE AND SUBMIT.
>> GOT IT.
>> I WAS JUST TOLD WE'RE KILLING
IT.
>> THAT'S SEVEN.
>> WE'LL HAVE TO DISCUSS --
>> DO YOU SEE IT?
WE'RE GOOD.
>> ALL RIGHT, CONGRATULATIONS.
OKAY.
NOW, WE'RE MOVING TO THE NEW
CONCEPTS.
MANY TIMES WE DO PRESENT -- WE
USUALLY PRESENT THEM IF THEY ARE
OF PARTICULAR INTEREST OR WE'RE
LOOKING FOR INPUT.
WE'RE NOT PLANTING ON PRESENTING
THIS TIME.
I BELIEVE THERE ARE FOUR.
DO WE HAVE THE NEW INITIATIVE
SLIDE?
OH, THREE, SORRY.
RIGHT, ONE WAS A REISSUE WE HAD
WRONG.
OKAY.
THERE WE GO.
NOW, THE BRAIN INITIATIVE WAS
PUBLICLY PRESENTED YESTERDAY.
AGAIN, THE MATERIAL IS
AVAILABLE.
WE'RE NOT HAVING PRESENTATIONS
BUT WE'RE MORE THAN HAPPY TO
ANSWER ANY QUESTIONS YOU MAY
HAVE.
AND AGAIN, I'M GOING TO HAVE A
MOMENT OF SILENCE.
OKAY.
LOOKS GOOD.
DO WE HAVE A MOTION TO MOVE
FORWARD?
I HAVE A MOTION.
A SECOND?
>> SO MOVED.
>> I HAVE A SECOND.
WE'LL DO WHAT WE DO BEST, WE'LL
VOTE IN THE ECB.
CONSIDERING THIS IS THE LAST
ITEM FOR THE DAY -- IT'S OKAY.
LOOK AT THAT.
3:23.
HEY!
>> (INAUDIBLE).
>> YEAH, OKAY.
WE HAVE MOVED THROUGH THE
CONCEPT CLEARANCE PHASE.
OKAY.
SO WE ARE NOW AT THE END OF THE
OPEN SESSION.
I BELIEVE I'M GOING TO HAVE TIM
MENTION SOMETHING ABOUT THE
UPCOMING HAPPY HOUR.
AND THEN WE'LL --
>> WE'LL START HAPPY HOUR AT 5
P.M. WHEN THE APPETIZERS WILL BE
PUT OUT.
SO, YOU HAVE A LITTLE BIT OF
TIME.
WE LOOK FORWARD TO SEEING
EVERYONE.
IT'S IN HELLO BETTY, IT'S IN THE
SECOND FLOOR, THIRD FLOOR OF THE
CANOPY HOTEL.
>> EXCELLENT.
WALTER, DO YOU WANT TO GAVEL US
OUT?
>> YEP, I JUST WANT TO MENTION,
AS YOU SAW IN JOHN'S SLIDE ABOUT
THE NUMBER OF INVESTIGATORS
FUNDED BY "BRAIN," IF "BRAIN"
CLOSES DOWN THEY ARE GOING TO BE
COMING TO US.
IT'S GOING TO PUT EVEN MORE
PRESSURE ON NINDS, FOR SURE.
>> AND MORE BRAIN.
MORE BRAIN.
>> WALTER, IT'S ACTUALLY NOT A
BAD THING.
A LOT OF THOSE INVESTIGATORS ARE
NOT THINKING ABOUT
DISEASE-RELATED PROBLEMS, AND
THEY NEED US TO MAKE THOSE
CONNECTIONS.
SO THEIR TECHNOLOGICAL SKILLS,
SOME OF OUR KNOWLEDGE OF DISEASE
MECHANISM, COULD MERGE TOGETHER
IN BEAUTIFUL WAYS.
>> YEAH, I AGREE WITH THAT
COMPLETELY.
EVEN ON THE DEVELOPMENTAL THING
THEY ARE TALKING ABOUT
20-YEAR-OLDS, SO I THINK, YOU
KNOW, TO MAKE IT TRANSLATIONAL
AND MAKE IT IMPORTANT FOR HUMAN
HEALTH AND FOR JUST FUNDAMENTAL
AGING BIOLOGY, I THINK REALLY
PUTTING THESE PEOPLE TOGETHER
WILL MAKE IT EVEN STRONGER, AND
IT WOULD BE A GREAT THING THAT
PROBABLY CONGRESS WOULD WANT TO
SUPPORT EVEN MORE, MAYBE, OR
NOT.
>> SOUND GOOD TO ME, LOUISE.
>> MAYBE.
>> YEP.
>> YOU HAVE TO GAVEL US OUT.
>> ALL RIGHT.
GAVELED OUT.
ALL RIGHT.
THANK YOU, EVERYONE.
WE'LL RECONVENE TOMORROW. 6017 04:15:06,791 [END OF PROGRAM]