>> I'D LIKE TO CALL THE 124th
MEETING TO THE DIRECTOR OPEN AND
THAT'S AS CLOSE AS I CAN GET TO
A GAVEL AND IT'S SAFER.
I WANT TO THANK YOU FOR TAKING
TIME FROM BUSY SCHEDULES TO BE
WITH US TODAY AND TOMORROW.
THE MEETING WILL BE HELD TODAY
FROM 10:00 A.M. TO ABOUT 4:15
P.M. EASTERN TIME.
THEM AGAIN TOMORROW 10:00 A.M.
TO 2:45 EASTERN TIME.
ON BOTH DAYS THE MEETING WILL BE
RECORDED.
THE MEETING IS OPEN TO THE
PUBLIC AND CAN BE ACCESSED BY
THE VIDEOCAST.
I KNOW YOU APPRECIATE HOW FULL
THE NEXT COUPLE OF DAYS ARE
GOING TO BE AND WE'LL DO OUR
VERY BEST TO STAY ON TIME I'VE
ASKED DR. SCHWETZ TO HELP KEEP
US ON TIME AND INHERITED WHAT I
USED SO MANY YEARS.
TARA.
>> IT'S A VIRTUAL BELL.
THIS IS WHAT IT WILL SOUND LIKE.
HOPEFULLY IT WILL COME THROUGH.
THE MEETING IS OPEN TO THE
PUBLIC INCLUDING MEMBERS OF THE
PRESS AND IT IS BEING WEBCAST
AND STREAMING LIVE RIGHT NOW.
MEETING PRESENTATIONS AND ANY
SUPPLEMENTAL MATERIAL WILL BE
POSTED ON THE ACD WEBSITE AT THE
TIME OF EACH PRESENTATION.
AND THE MEETING WAS ANNOUNCED IN
THE FEDERAL REGISTER ON MAY 13,
2022.
WE DID RECEIVE PUBLIC COMMENT
AND THE MEMBERS CAN SHARE IT ON
THE FILE SITE.
ACD MEMBERS AND PRESENTERS ARE
USING THE ZOOM APPLICATION FOR
OUR MEETING TODAY AND TOMORROW.
YOU CAN USE THE CHAT FEATURE AS
QUESTION ASKED OR MAKE A COMMENT
OR QUESTION.
WHEN AN ACD MEMBER DOES WISH TO
MAKE A COMMENT, WE ASK YOU
PLEASE TURN ON YOUR VIDEO AND
MAKE SURE THAT YOU ARE UNMUTED
SO THAT OUR REPORTING CAN
CAPTURE THAT.
THAT'S OVER FOR THE LOGISTICS SO
BACK TO YOU.
>> LET ME PREVIEW THE AGENDA WE
HAVE OVER THE NEXT COUPLE OF
DAYS.
WE'LL BEGIN WITH A REPORT FROM
ME.
THAT WILL INCLUDE BUDGET UPDATES
FROM NEIL SHAPIRO AND A SHORT
BREAK AT 11:30 A.M. AND THEN
TARA WILL GIVE A PRESENTATION ON
ARPA-H TO UPDATE PEOPLE AS TO
WHERE PER AND THAT WILL BE
FOLLOWED BY DISCUSSION.
WE'LL DO A QUICK BREAK AT 12:45.
WE'LL HAVE A PRESENTATION FROM
DR. FAUCI FOLLOWED BY
PRESENTATIONS BY DR. KOROSHETZ
AND BIANCHI ON RECOVER AND
UPDATES ON COVID-19 IN CHILDREN
AND PEOPLE OF REPRODUCTIVE AGE
RESPECTIVELY.
WE'LL THEN DO A FINAL BREAK FOR
THE DAY AT AROUND 3:30 AND AT
3:45 DR. MIKE LAUER WILL DO AN
UPDATE ON THE RIGOR AND ANIMAL
USE SO MANY PARTICIPATED ON.
AT THE END OF THE DAY WE'LL HAVE
A FEW QUICK CLOSING COMMENTS AND
ADJOURN.
TOMORROW, JUNE 10, WE WILL LEAD
OFF WITH A DISCUSSION BY
DR. MARIE BERNARD ON OUR
DIVERSITY, EQUITY, INCLUSION AND
ACCESSIBILITY STRATEGIC
PLANNING.
WE'LL THEN HAVE WHAT HAS BECOME
A TRADITION OVER THE LAST
SEVERAL MEETING AN UPDATE FROM
OUR UNITE GROUP AND EACH OF THE
FIVE CO-CHAIRS AND THOSE FIVE
WORK STREAMS WILL HAVE A READOUT
AND WE'LL HAVE TIME FOR GENERAL
DISCUSSION.
THERE WILL BE A BREAK AROUND
12:30.
WE'LL GET BACK TO DEATOGETHER AN
FOR THE FINAL PRESENTATIONS ON
NIH DATA SHARING POLICY AND THE
SUPPORTIVE INFRASTRUCTURE
EFFORTS AND THAT WILL BE
PRESENTED BY DOCTORS JORGENSON,
LAUER AND GREGURICK AND END UP
WITH CLOSING COMMENTS AND
ADJOURN.
A LOT OF MATERIAL TO COVER IN A
SHORT PERIOD OF TIME.
THE TENDENCY IS TO SIT BACK AND
JUST LISTEN BUT AS THE MEMBERS
OF THE COMMITTEE WHO HAVE BEEN
ON FOR A WHILE IT'S A MUCH
BETTER MEETING IF THE COUNCIL
MEMBERS ENGAGE.
PLEASE, DON'T BE PASSIVE.
THERE'S A FEW I DON'T HAVE TO
SAY THAT TO IN GENERAL I KNOW
BUT DON'T BE PASSIVE AND IF YOU
HAVE A QUESTION AS YOU'RE GOING
ALONG IN A PRESENTATION -- I
ASSUME THE CHAT FUNCTION IS
ENABLED TARA.
>> THAT'S RIGHT.
PUT YOUR QUESTION IN THE CHAT
BOX AND IF THERE'S A LOGICAL
BREAK TO THE PRESENTATION, TARA
OR I WILL ACKNOWLEDGE YOU, IF
NOT IT RECORDS THE QUESTION AND
AT THE END OF THE PRESENTATION
WE'LL CIRCLE BACK AND IT KEEPS
THE THOUGHT FRESH BECAUSE YOU'VE
CAPTURED IT.
PLEASE, LET'S MAKE THIS AS
INTERACTIVE AS POSSIBLE AND
AGAIN AS THE COUNCIL MEMBERS WHO
SERVED BEFORE KNOW, AT THE END
OF THE REPORT COUNCIL MEMBERS
CAN BRING UP ANY TOPIC THEY WISH
AND I OR THE TEAM WILL DO OUR
BEST TO ANSWER WHATEVER THE
QUESTION IS OR FOR ANY COMMENT
YOU MAY HAVE.
SO BEFORE WE GET STARTED WITH
THE REST OF THE AGENDA, IF I CAN
HAVE THE SLIDE.
I THOUGHT IT WOULD BE IMPORTANT
TO ACKNOWLEDGE THE PASSING OF
MR. JOHN PORT.
I'M SURE MANY HAVE HEARD THE
NEWS MR. PORTER IN THE HEALTH
AND HUMAN SERVICES AND EDUCATION
AND RELATED ACTIONS THAT OVERSAW
NIH FUNDING PASSED AWAY LAST
WEEK AFTER AN EXTENDED ILLNESS.
MR. PORTER WAS ONE OF THE
GREATEST CHAMPIONS FOR NIH IN
THE HISTORY OF THE AGENCY.
HE AND HIS COLLEAGUES IN THE
HOUSE, FOLKS LIKE MR. DAVID OBE
AND MR. TOM HARKIN AND
MR. SPECTER, WORKED TO DOUBLE
THE NIH BUDGET IN FIVE YEARS
FROM THE PERIOD FROM 1998 TO
2003.
IT WAS A REMARKABLE LEGISLATIVE
ACHIEVEMENT AND ENABLED
BIOMEDICAL RESEARCH TO MOVE
FORWARD AT AN UNPRECEDENTED
PACE.
THEN AGAIN AS I'M SURE MANY OF
YOU KNOW, AFTER HIS CAREER IN
CONGRESS, MR. PORTER CONTINUED
TO WORK HARD FOR INCREASED
INVESTMENTS IN BIOMEDICAL
RESEARCH AND ALWAYS HAD A FOCUS
ON HOW THESE ADVANCED WOULD HELP
OVERCOME DISEASE, ALLEVIATE
SUFFERING AND IMPROVE PEOPLE'S
HEALTH.
NIH HAS LOST ONE OF OUR MOST
STALWART HEROES AND WE'LL
FOREVER BE IN HIS DEBT.
OUR HEARTS GO OUT TO HIS WIFE,
AMY WHO LEADING AT THIS TIME
AND WE A BUILDING CALLED THE
JOHN EDWARD PORTER NEUROSCIENCE
CENTER WHICH WE DEDICATED IN
20
2014.
THAT BUILDING WAS SOMEWHAT OF AN
EXPERIMENT WHERE WE HAD AN
INDIVIDUAL CENTER OCCUPY THE
SPACE, MULTIPLE INSTITUTES AND
CENTERS OCCUPY THE SPACE WITH
SHARED GOVERNANCE, COME CORES
AND PLACE TO HAVE A CUP OF
COFFEE.
THAT HAS SINCE BEEN REPLICATED
IN OTHER BUILDINGS HAVING PROVED
TO BE SO SUCCESSFUL AND NO DOUBT
THE SCIENCE THAT WAS CONDUCTED
IN THOSE WALLS WILL HELP CARRY
OUT HIS EXTRAORDINARY LEGACY.
SO OKAY.
HERE'S MANY OF THE APPOINTMENTS
AND DEPARTURES SINCE WE LAST
MET, TALK ABOUT A FEW AWARDS AND
HONOREES, NIH IS FORTUNATE TO
HAVE.
WE'LL GET BUDGET UPDATES AND
TALK ABOUT INITIATIVES AND A
SAMPLING, OBVIOUSLY AND PROVIDE
AN UPDATE ON OUR EFFORTS TO
ADDRESS SEXUAL HARASSMENT AND
SEND WITH -- END WITH A COUPLE
THINGS THAT KEEP ME UP AT NIGHT
AND PUT THEM THERE AS A WAY TO
PROMPT DISCUSSION BY THE COUNCIL
ON TWO THE DIFFERENT TOPICS.
I LOOK FORWARD TO HEARING YOUR
THOUGHTS ON THESE TOPICS WHEN WE
GET TO THAT.
SO IF I CAN HAVE THE NEXT SLIDE.
SO THIS IS A PICTURE OF THE
DIRECTOR PRIOR TO THE LAST
MEETING.
AND AS CAN SEE BY WHO'S THERE
AND WHO'S NOT THERE ANYMORE, WE
HAVE A NUMBER OF CHANGES.
MOST OBVIOUS IS FRANCIS STEPPING
DOWN AS NIH DIRECTOR AT THE END
OF THE CALENDAR YEAR.
TWO MEMBERS OF THE ACD ARE
ROTATING OFF AFTER THIS MEETING
AFTER GRACIOUSLY AGREEING TO
SERVE AFTER LAST YEAR A
SIX-MONTH EXTENSION.
I'D LIKE TO THANK THEM FOR THEIR
SERVICE AND MANY CONTRIBUTIONS
OVER THE YEARS.
FIRST IS DAVID GLASSER
ENGINEERING DIRECTOR AND TARA AT
LIFE SCIENCES.
DAVID CO-CHAIRED THE ACD WORKING
GROUP ON CHANGING THE CULTURE ON
SEXUAL HARASSMENT AND A MEMBER
OF THE WORKING GROUP ON ETHICAL
CONSIDERATIONS FOR INDUSTRY
PARTNERSHIP ON RESEARCH TO HELP
END THE OPIOID CRISIS.
AND HE CO-CHAIRS THE ACD WORKING
GROUP ON ARTIFICIAL INTELLIGENCE
AND TRIED VAINLY TO TRY TO TEACH
ME SOMETHING ABOUT ARTIFICIAL
INTELLIGENCE.
NOT SURE YOU SUCKCEEDED BUT IT
WAS THE PUPIL NOT THE TEACHER.
AND THEN THE OFFICER OF THE
MEDICAL SCHOOL ALONG WITH HIS
SERVICE ON THE ACD, JAMES SPART
OF THE FDA'S VACCINE AND
BIOLOGICAL PRODUCTS ADVISORY
COMMITTEE AND PRESIDENT BIDEN'S
COVID-19 EQUITY TASK FORCE.
THOUGH WE ARE LOSING JAMES, NO
DOUBT WE'LL CONTINUE TO WORK
CLOSELY WITH HIM IN THE LATTER
TWO ROLES.
I DON'T KNOW IF EITHER OF YOU
WANT TO SAY SOMETHING BRIEFLY.
>> THANK YOU FOR THE OPPORTUNITY
I HAVE LEARNED A LOT AND
PRIVILEGED TO BE PART OF THIS.
I FEEL I UNDERSTAND MUCH MORE
THAN I USED ABOUT THE PEOPLE AND
PROCESSES OF ADVANCING HEALTH.
>> THANK YOU.
JAMES.
>> LARRY, I WOULD ECHO THAT AND
LEARNED A GREAT DEAL AND HAPPY
TO BE PART OF THIS IMPORTANT
GROUP AND THE CONVERSATIONS
WE'VE HAD AND WISH YOU SUCCESS
IN THE TRANSITION HAPPENING
HERE.
THANK YOU, I APPRECIATE IT.
>> SO EVERYBODY IS CLEAR, WE
LEARNED A LOT MORE FROM THESE
TWO GENTLEMEN THAN THEY LEARNED
FROM US.
WE'RE VERY APPRECIATIVE.
IF WE CAN VIRTUALLY THANK THEM,
THAT'D BE GREAT.
NEXT, WE HAVE SEVERAL NEW
MEMBERS OFFICIALLY JOINING THE
ACD AT THIS MEETING AND PLEASED,
IF I MISPRONOUNCE YOUR NAME,
DESPITE PRACTICING, CORRECT ME
IMMEDIATELY.
DON'T WAIT.
THE FIRST NEW MEMBER IS IS THE
MARK ZUCKERBERG DISTINGUISHED
PROFESSOR OF PEDIATRICS,
BIOENGINEERING AND SCIENCES AND
BIOSTATISTICS AT UCSF AND THE
CHIEF DATA SCIENTIST FOR THE
UNIVERSITY OF CALIFORNIA HEALTH
SYSTEM.
WELCOME ATUL.
HOWARD CHANG THE PROFESSOR OF
CANCER RESEARCH AT STANFORD
UNIVERSITY.
THE DIRECTOR AND FOUNDER OF ICAP
FORMALLY THE INTERNATIONAL
CENTER FOR AIDS CARE AND
TREATMENT PROGRAMS.
THE DIRECTOR OF COLUMBIA WORLD
PROJECTS AND CHAIR OF GLOBAL
HEALTH AND SCHOOL OF PUBLIC
HEALTH AT COLUMBIA UNIVERSITY.
THE NEXT NEW MEMBER, THE ENDOWED
ASSOCIATE PROFESSOR, DEPARTMENT
OF PSYCHIATRY AND BEHAVIORAL
SCIENCES AT DUKE UNIVERSITY
MEDICAL CENTER THEY SERVED ON
THE ACD BRAIN INITIATIVE WORKING
GROUP AS AN AD HOC MEMBER.
THEN GARTH GRAM AT YOUTUBE AND
GOOGLE HEALTH.
MANY OF US KNOW GARTH DURING HIS
PREVIOUS SERVICE AS U.S. DEPUTY
ASSISTANT SECRETARY FOR HEALTH.
GARTH HAS JUMPED IN AND
GRACIOUSLY AGREED TO BE THE NEW
CO-CHAIR TO THE GENOME DATA
ACCESS GROUP.
WE DON'T HAVE REQUESTS FOR THE
HELO GENOME WORKING GROUP FOR
THIS ACD MEETING BUT I WANTED TO
RTANT THIS AGREEMENT IS IS
WITH THE LACK FAMILY AND WE
THANK YOU FOR THEIR CONTINUOUS
SUPPORT OF RESEARCH AND
WILLINGNESS TO COLLABORATE ON
THIS IMPORTANT ISSUE.
YOU MAY RECALL NIH LACKS
AGREEMENT WAS CREATED IN 2013 TO
ESTABLISH A MUTUALLY
COLLABORATIVE EFFORT REFLECTING
THE WISHES OF THE LACKS FAMILY
REGARDING RESEARCH USING HELA
CELLS WHILE RESPECTING THE
FAMILY.
IT PUTS ACCOUNTABILITY AND
REVIEW OF INVESTIGATOR REQUESTS
FOR ACCESS TO THE HELA CELL
GENOME SEQUENCE DATA THROUGH THE
ACD.
WE WANT TO THANK THE FAMILY AND
THE SCIENTIFIC COMMUNITY FOR
THEIR CONTINUED COMMITMENT TO
UPHOLDING THIS AGREEMENT.
I'D LIKE TO THANK THE CO-CHAIR
FOR HIS LEADERSHIP ON IS THIS
IMPORTANT GROUP.
AND VITAL TO THE ONGOING
SUCCESSION IN ENJOYING THE
LACKS' FAMILY PRIVACY AND WE
LOOK FORWARD TO WORKING WITH
GARTH IN HIS NEW ROLE.
IF YOU'D ALL JOIN ME IN
WELCOMING ALL THE NEWEST MEMBERS
OF THE ACD.
OKAY.
SO WE HAVE A SERIES OF NEW
APPOINTMENTS, DEPARTURES AND
SEARCHS.
FOLLOWING FRANCIS' RETIREMENT AS
NIH DIRECTOR AND MY SHIFT TO THE
ACTING DIRECTOR ROLE, DR. TARA
SCHWETZ IS NOW SERVING AS THE
ACTING NIH PRINCIPAL DIRECTOR
AND YOU'LL BE SEEING AND HEARING
A LOT FROM TARA DURING THIS ACD
MEETING AND BEYOND.
IF I MAY HAVE THE NEXT SLIDE,
PLEASE.
SLOT BEING INTO TARA'S ROLE AS
DIRECTOR, DR. ACLUND THE ACT
SOCIETY DEPUTY DIRECTOR AND
PREVIOUSLY REPORTED, WITH CARRIE
MO
MOLENETS ON DETAIL AT THE WHITE
HOUSE AND IF I CAN HAVE THE NEXT
SLIDE.
YOU KNOW DR. NED SHARPLESS
STEPPED DOWN FROM HIS ROLE AS
DIRECTOR AND WE ALL OWE A GREAT
DEAL OF GRATITUDE FOR HIS
SERVICE.
WITH THE DEPARTURE OF NED,
DR. LOWE IS REPRIDESING --
REPRISING HIS ROLE AS THE
DIRECTOR AND IT'S A THE SECOND
TIME HE'S SERVED IN THAT
IMPORTANT CAPACITY.
SIMILARLY, IF I CAN HAVE THE
NEXT SLIDE, WE HAVE AN ACTING
DIRECTOR OF THE NATIONAL CENTER
FOR TRANSLATION SCIENCES
FOLLOWING THE DEPARTURE OF CHRIS
AUSTIN.
AND DR. CHRISTINE HUNTER IS
FILLING IN DUAL ROLES AS
DIRECTOR TO BEHAVIORAL AND
SCIENCES RESEARCH AND THE OFFICE
OF BEHAVIORAL AND SOCIAL
SCIENCES RESEARCH.
DR. BERKOW CONTINUES TO ROLE AS
ACTING CHIEF OF STAFF.
A ROLE HE BEGAN WHILE FRANCIS
WAS STILL DIRECTOR AND FOR
CONTINUING TO SERVE AS THE
ACT
ACTING ASSOCIATE DIRECTOR AND
PUBLIC LIAISON.
WHEN PEOPLE ARE ASKING ME HOW I
AM, MAYBE I DON'T LOOK WELL,
THEY'RE ALWAYS ASKING HOW I'M
DOING AND I ASSURE I'M DOING
REALLY WELL BECAUSE OF THESE
FOLKS AND THE OTHER LEADERSHIP
TEAM ACROSS NIH.
I'M ABLE TO COUNT ON THEM EACH
AND EVERY DAY.
THOSE WHO REMAIN IN THEIR ROLES
AND THOSE WHO HAVE TAKEN ON THE
ACTING ROLES WE'RE VERY
FORTUNATE TO HAVE SUCH A DEEP
BENCH WE CAN RAPIDLY FILL SO
MANY KEY ROLES AT THE AGENCY
WITH PEOPLE WHO ARE READY TO
STEP IN.
THAT'S MORE OF WHAT WE MEAN WHEN
WE SAY SUCCESSION PLANNING IN A
GOVERNMENT ENTITY.
THE INDIVIDUALS WHO STEP IN
AREN'T NECESSARY GOING TO BECOME
THE PERMANENT HOLDERS OF THE
POSITION BUT THEY'RE WILLING TO
STEP IN FOR SOME PERIOD OF TIME
AND DO SUPERB JOBS.
I'M TREMENDOUSLY GRATEFUL TO ALL
OF THOSE FOLKS.
SO YOU'LL HERE A GREAT DEAL MORE
ABOUT THIS LATER FROM
DR. SCHWETZ BUT THE CREATION OF
THE NEW ADVANCE ARPA-H SECRETARY
BECERRA APPOINTED DR. RUSSELL AS
ACTING DEPUTY DIRECTOR OF
ARPA-H.
IN THIS ROLE, ADAM WILL LEAD THE
PROCESS BY BUILDING OUT THE
INFRASTRUCTURE, BUSINESS
PROCESSES AND POLICIES.
ADDITIONAL STAFF WILL BE BROUGHT
ONBOARD TO HELP BUILD THE
OPERATIONAL ELEMENTS YOU NEED IN
STANDING UP A NEW ORGANIZATION
WHILE PRESIDENT BIDEN SEARCHS
FOR THE PRESIDENTIALLY APPOINTED
INAUGURAL DIRECTOR.
I SHOULD HAVE ADDED THE
PRESIDENT CONDUCTING A SEARCH
FOR THE APPOINTED NCI DIRECTOR
AS WELL.
AND I'D LIKE TO WELCOME THE
FORMER CDC DIRECTOR DURING THE
BUSH ADMINISTRATION AND IS
APPOINTED THE NEW CEO FOR THE
FOUNDATION OF NIH.
PRIOR, DR. GERBERDING WAS IN
POPULATION HEALTH AND
SUSTAINABILITY AT MERCK.
WE'RE DELIGHTED TO HAVE JULIE
JOIN IN THIS VERY IMPORTANT ROLE
GIVEN THE INCREASING
COLLABORATION HAS PLAYED IN A
NUMBER OF THINGS WE'RE ENGAGED
IN.
NOW WE'LL DO AWARDS AND
HONOREES.
I'M DELIGHTED TO SHARE THE NEWS.
FIRST TWO FINAL EFFISTS TO THE
SERVICE TO AMERICA KNOWN AS THE
SAMIS.
DR. BIANCHI WAS A FINALIST FOR
THE COVID-19 RESPONSE CATEGORY
AND DR. CLIFF LANE WHO HAS
ADVANCED IN THE CAREER
ACHIEVEMENT CATEGORY.
AND THE ADVOCACY AWARD TWO
PEOPLE WELL KNOWN TO US FRANCIS
COLLINS WHO AS YOU KNOW IS NOW
SERVING AS THE ACTING SCIENCE
ADVISER TO THE PRESIDENT IN
ADDITION TO RUNNING HIS GENOMICS
PROGRAM AND DR. VIVIAN PINN
AWARDED FOR HER ACHIEVEMENTS IN
PUBLIC HEALTH AND EVERYONE FOR
THEIR WORK IN RAPID IN THE RAPID
TRANSLATIONAL ROLE.
AGAIN VERY FAMILIAR FACES ADDING
TO THE MANY ACCOLADES.
DR. TONY FAUCI HAD BEEN AWARDED
THE EXCELLENCE IN PUBLIC SERVICE
AWARD.
THESE ARE JUST A SAMPLING OF THE
MANY AWARDS THAT OUR STAFF HAVE
RECEIVED.
AND BUDGET AND LEGISLATIVE
UPDATES.
THIS IS A SHOT OF MY COLLEAGUES
AND I PARTICIPATING IN THE HOUSE
APPROPRIATIONS COMMITTEE
HEARING.
AND THIS IS THE SENATE
APPROPRIATIONS.
I'LL HIGH -- SAY AT A HIGH
LEVEL THE TEAM WAS VERY TO
PROVIDE CLEAR AND THOROUGH
ANSWERS TO ALL THE MEMBERS A
QUESTIONS AND WE WERE PLEASED
THAT THE HEARING WAS
PROFESSIONAL IN BOTH INSTANCES
AND I'LL PASS IT ON TO NEIL
SHAPIRO AND ADRIENNE HALLET FOR
THE BUDGETS AND LEGISLATIVE
ACTIVITY.
NEIL, PLEASE TAKE IT AWAY.
>> GOOD MORNING, EVERYONE.
CAN YOU HEAR ME?
STARTING WITH THE CURRENT FISCAL
YEAR, 2022, WE RECEIVED THE
CONSOLIDATED APPROPRIATIONS BILL
ON MARCH 15 AFTER FOUR
CONTINUING RESOLUTIONS OR C.R.s.
JUST TO RECAP OF WHAT IS
SUPPOSED TO HAPPEN,
APPROPRIATIONS ARE SUPPOSED TO
BE PASSED BY THE END OF
SEPTEMBER SO WE HAVE THEM
AVAILABLE FOR THE FISCAL YEAR
STARTING OCTOBER 1.
THAT HAS ONLY HAPPENED ONCE AND
WE START THE YEAR WITH
CONTINUING RESOLUTION WHERE
ESSENTIALLY WE OPERATE UNDER THE
SAME FUNDING LEVEL AS THE PRIOR
YEARS' ENACTED APPROPRIATION SO
WE WERE UNDER THE 21 LEVEL UNTIL
CONGRESS PASSED THIS OMNIBUS ON
MARCH 15 AND AS I SAID, THAT'S
NEARLY HALF THE FISCAL YEAR FROM
OCTOBER THROUGH MID MARCH SO
THAT POSES CHALLENGES IN TERMS
OF SPENDING A HIGHER LEVEL IN
THE SECOND HALF OF YEAR.
WE'RE SOMEWHAT ACCUSTOMED TO
DEALING WITH THAT PARTICULAR
CHALLENGE.
ANOTHER THING WE'LL TALK ABOUT
MORE LATER IS THE CREATE OF
ARPA-H ALSO IN THE OMNIBUS BILL.
CONGRESS PUT IN A PROVISION AND
CREATED ARPA-H WITHIN THE
DEPARTMENT OF HHS WITH THE
AUTHORITY TO CONTROVERSY IT
WHICH ACTUALLY HAPPENED AND THE
TYPE 1 DIABETES FUND IS PART OF
THE ANNUAL FUNDING PROFILE THAT
IS NOT IN THE REGULAR
APPROPRIATIONS BILL.
IT'S CALLED MANDATORY FUNDING
AND COMES IN AN AUTHORIZING BILL
INSTEAD OF ANS BILL.
-- AN APPROPRIATIONS BILL AND
MAY BE RE-AUTHORIZED FOR YEARS
AND GOOD TO KNOW WE WILL HAVE
THE MONEY IN FOLLOWING YEARS
SINCE IT DOESN'T NECESSARILY GET
INCLUDED IN THE ANNUAL
APPROPRIATION.
THE FLIP SIDE IS UNDER CURRENT
LAW WHEN IT HAPPENS FAR ENOUGH
IN ADVANCE, WE LOSE A BIT OF THE
MONEY THROUGH SEQUESTRATION.
THIS YEAR WE DID TAKE AN $8.5
MILLION HIT.
THIS IS A SUMMARY OF OUR FY22
APPROPRIATION.
ARPA-H WAS FUNDED AT $1 BILLION
OVER A THREE-YEAR PERIOD WITH A
NEW AGENCY.
WE'LL NEED ADDITIONAL YEARS IN
ORDER TO GET THAT GOING AND BE
ABLE TO SPEND THE MONEY WHICH IS
AVAILABLE.
NORMALLY NIH FUNDS ARE ONE-YEAR
APPROPRIATIONS WHICH MEANS WE
HAVE TO OBLIGATE THEM AND GET
THEM OUT THE DOOR.
WITH ARPA-H THERE'LL BE TWO
ADDITIONAL YEARS.
THE INCREASE WAS A HEALTHY ONE.
IT FOLLOWS ON SEVERAL YEARS OF
HEALTHY INCREASES.
SINCE FISCAL 2016 AFTER SEVERAL
YEARS WE ESSENTIALLY HAD A FLAT
BUDGET AND RECEIVED INCREASES
TAKING OUR FUNDING UP ROUGHLY
50% OVER SEVEN YEARS.
THAT'S BEEN VERY WELCOME AND
APPRECIATIVE CONGRESS HAS BEEN
ABLE TO SUPPORT US THAT WAY IN
RECENT YEARS.
INCLUDED IN THAT WAS THE GENERAL
INCREASE OF 3.4%.
THIS IS ALWAYS A CONCERN HOW
MUCH OF AN ANNUAL APPROPRIATION
INCREASE IS AVAILABLE TO THE
INSTITUTES AND CENTERS FOR
GENERAL PURPOSES AS OPPOSED TO
BEING TARGETED AT SPECIFIC
RESEARCH OR OTHER INITIATIVES TO
GIVE YOU A CONTEXT THE 7.9% IF
YOU TAKE OUT ARPA-H IS ABOUT 60%
GENERAL AND 40% FOR SPECIFIC
INITIATIVES.
THIS LISTS THE LARGEST OF THE
TARGETED INCREASES IN THE
OMNIBUS.
ALZHEIMER'S DISEASE.
THIS HAS TYPICALLY BEEN THE
BIGGEST PRIORITY FOR CONGRESS
AMONG THE INITIATIVES.
$289 MILLION THIS YEAR.
IT'S BEEN A LITTLE HIGHER THAN
THAT IN SOME PREVIOUS YEARS.
THE SECOND THE INITIATIVE MAKES
IT DIFFICULT TO FUND ALL
MERITORIOUS APPLICATIONS SO
CONGRESS TRIED TO SUPPORT THEM
WIN ADDITIONAL FUNDING TO TRY TO
GET THAT SUCCESS RATE HIGHER.
AND THEN A NUMBER OF
INITIATIVES, MANY OF WHICH WERE
REQUESTED IN THE PRESIDENT'S
BUDGET FOR '22.
THE HEAL INITIATIVE, FOR
EXAMPLE, BUILDINGS AND
FACILITIES, CYBER SECURITY,
THESE ARE ALL PRIORITIES FOR NIH
WE'RE HAPPY CONGRESS WAS ABLE TO
SUPPORT.
THE BRAIN INITIATIVE AND ALL OF
US RESEARCH PROGRAM THOSE WERE
PLANNED INCREASES THAT PROVIDED
A FUNDING PROFILE FOR THOSE
PROGRAMS.
THAT CONTINUES WITH THE
STATUTORY LEVEL THERE.
HEALTH DISPARITIES AND THE
COVID-19 FUNDING FOR TARGETED
RESEARCH ON AREAS OF COVID-19
WHERE WE EXPECT THERE TO BE A
LONG-TERM NEED INCLUDING MENTAL
HEALTH, PEDIATRIC RESEARCH AND
COMMUNITY ENGAGEMENT I
APPRECIATE CONGRESS WAS ABLE TO
SUPPORT THOSE AND WE'LL SEEK
ADDITIONAL FUNDS FOR THOSE
PRIORITIES INCLUDING BUILDING
AND FACILITIES WHICH HAS BEEN A
GREAT LONG-TERM NEED FOR NIH.
THE PRESIDENT'S BUDGET WAS ALSO
DELAYED.
THEY WERE HOPING FOR
CONGRESSIONAL APPROPRIATIONS
ACTION IN TIME TO FACTOR THEM IN
THE '23 REQUEST.
ULTIMATELY THAT WASN'T POSSIBLE.
THE APPROPRIATION CAME TOO LATE
IN THE YEAR AND THE BUDGET HAD
TO BE DEVELOPED ASSUMING THE
CONTINUING RESOLUTION AND FLAT
LEVEL FOR 2022 AS IT TURNED OUT
PASSING THE OMNIBUS TWO WEEKS
BEFORE THE BUDGET WAS RELEASED
BUT BECAUSE IT TAKES ABOUT
MONTHS OR MORE TO DEVELOP THE
BUDGET IT WASN'T ENOUGH TIME TO
PIVOT AND TO BE ABLE TO BASE THE
BUDGET OFF THE ENACTED
APPROPRIATION RATHER THAN THE
CONTINUING RESOLUTION.
THAT'S CREATED A FAIR BIT OF
CONFUSION WHEN YOU COMPARE THE
'22 BUDGET TO THE APPROPRIATION.
IT DOESN'T REALLY SHOW YOU WHAT
THE ADMINISTRATION WAS TRYING TO
DO WHEN IT WASN'T CONSIDERING
THE APPROPRIATION LEVEL FOR '22.
TO GIVE AN EXAMPLE, IF YOU LOOK
AT OUR PROGRAM LEVEL WITH A
$16.3 BILLION INCREASE, YOU CAN
SEE HERE, MOST OF THAT WASES OF
THE RESULT OF REQUESTED
INCREASES FOR ARPA-H AND FOR A
PANDEMIC PREPAREDNESS PROPOSAL
I'LL TALK ABOUT IN A MINUTE.
THE REMAINING INCREASE OF ABOUT
$270 MILLION IS A NET LEVEL.
WHEN YOU CONSIDER WHEN YOU
COMPARE THE BUDGET TO THE
ENACTED LEVEL, SOME WERE
INCREASES, SOME WERE DECREASES
COMPARED TO THE OMNIBUS
APPROPRIATION WHERE BASED ON THE
BUDGET ON THE CONTINUING
RESOLUTION ALL INTENDED TO BE
INCREASES.
IT'S A LITTLE DIFFICULT TO
COMPARE '23 TO '22 AS A RESULT
OF THAT BUT WE'LL BE ABLE TO
BUILD ON THAT FOR 23.
GOING ON TO THE NEXT SLIDE AS
INTENDED IN THE PRESIDENT'S
BUDGET, THERE WAS A GENERAL
INCREASE OF 2% OVER THE
CONTINUING RESOLUTION AT THE
LOWER LEVEL FOR ALL THE
INSTITUTES AND CENTERS AS WELL
AS RESEARCH INITIATIVES IN THE
PRESIDENT'S BUDGET WHERE WE WERE
SEEKING SPECIFIC INCREASES AND
THE LARGEST ONES ARE NOTED HERE
MANY BUILDING ON THE '22 REQUEST
INCLUDING THE OPIOIDS PAIN
RESEARCH AND THE HEAL INITIATIVE
IN THE CYBER SECURITY AND
BUILDING FACILITIES.
IN EACH CASE THE REQUEST IN THE
BUDGET WAS SOMEWHAT LARGER BUT
WE ACCOUNTED FOR THE AMOUNT
CONGRESS DID PROVIDE IN '22
WITHIN THAT INITIAL REQUEST.
SO WE'RE HOPING THEY WILL
SUPPORT THESE PRIORITIES
ADDITIONALLY IN FY23 ON TOP OF
WHAT THEY WERE ABLE TO PROVIDE
US IN 2022.
WE HAVE INITIATIVES FOR CLIMATE
RESEARCH AND HAVE A STRATEGIC
PLAN FOR NUTRITION SCIENCE WE'RE
HOPING TO SUPPORT WITH
ADDITIONAL FUNDING IN 2023.
THOSE ARE SOME NEW PRIORITIES
FOR WHICH WE DIDN'T GET
INCREASES IN 2022.
THIS IS A MANDATORY PROPOSAL NOT
PART OF THE PROCESS.
ONE-TIME FUNDING AVAILABLE FOR
FIVE YEARS.
THE REQUEST OF A HEALTH AND
HUMAN SERVICES PROPOSAL IS $82
BILLION IN TOTAL BUT THE
RESEARCH COMPONENT IS AN
IMPORTANT PART OF THAT.
TO GIVE YOU AN IDEA OF WHAT IS
INCLUDED, THE PRE-CLINICAL R&D.
THE IDEA IS TO FOCUS ON 20 HIGH
PROFILE VIRAL FAMILIES CHOOSE
REPRESENTATIVE VIRUSES FOR THOSE
FAMILIES THAT WE CAN RESEARCH.
THEN THE SECOND EXPANDING
LABORATORY CAPACITY WHERE THERE
ARE GAPS DOUBLING THE ABILITY OF
THE VACCINE RESEARCH CENTER TO
DO PILOT LOT MANUFACTURING.
THE THIRD WOULD BE THE
DEVELOPMENT AND CLINICAL
EVALUATION OF VACCINES AND
THERAPEUTICS.
THE NEXT STEP IN CLINICAL
RESEARCH.
THIS WOULD INCLUDE HOST-TARGETED
THERAPEUTICS.
THE NEXT IS ESTABLISHING OR
EXPANDING CLINICAL TRIALS
NETWORKS.
THIS WAS CRUCIAL FOR US DEALING
WITH COVID WE WERE ABLE TO BUILD
ON EXISTING CLINICAL TRIALS
NETWORKS AND THIS FUNDING ALLOWS
THEM TO BE USED BEYOND COVID.
BIOSAFETY AND BIOSECURITY WITH
FUNDING FOR BSL3 AND 4 LABS FOR
HIGHER SECURITY AND ADDITIONAL
DIAGNOSTICS AND INNOVATIONS.
THIS WOULD BUILD ON THE RADX
TECH PROGRAM TO EXTEND BEYOND
COVID.
OVER ALL A VERY COMPREHENSIVE
PROPOSAL THAT WOULD PUT US IN
BETTER SHAPE TO DEAL WITH THE
NEXT PANDEMIC THAT HOPEFULLY
WILL BE FAR OFF BUT WE COULD BE
MUCH BETTER PREPARED.
WITH THAT, I WILL STOP.
>> AT THIS POINT I DON'T KNOW IF
WE SHOULD PROCEED THROUGH WITH
ADRIENNE'S AND PROCEED THROUGH
WITH BOTH OR DOES ANYONE HAVE
QUESTIONS THEY'D LIKE TO ADDRESS
TO NEIL AT THIS POINT.
USE THE RAISE THE HAND FEATURE
OR PUT SOMETHING IN THE CHAT
BOX, WE CAN FIND YOU.
>> I'LL GRAB THE MIC AND SKIP
THE PROCESS.
NEIL, I'M CURIOUS IN PARTICULAR
ABOUT THE PANDEMIC PREP PIECE
WHICH IS A SIGNIFICANT NEW AND
IMPORTANT INITIATIVE.
WHAT THE TIME LINE IS FOR THAT
PIECE IN PARTICULAR TO GET MORE
CLARITY ON HOW IT MOVES FROM
PRESIDENT'S BUDGET TO ACTUAL
LEGISLATIVE DISCUSSION TO
APPROVAL.
WHEN WILL THAT GET CLEARER?
>> I THINK ADRIENNE CAN PROBABLY
GIVE YOU A BETTER IDEA OF THE
TIMING BUT BECAUSE IT'S
MANDATORY IT WOULD RELY ON
AUTHORIZING COMMITTEES IN
CONGRESS TO TAKE IT UP AND MOVE
IT FORWARD.
ADRIENNE CAN TALK MORE ABOUT
THAT IN HER PIECE.
>> THE PROPOSAL HAVE A TOUGHER
ROAD BECAUSE IT'S PART OF A
GENERAL BUDGET.
IT'S PART OF THE $1 TRILLION
U.S. GOVERNMENT BUDGET.
THERE AREN'T ASSIGNED OFFSETS.
AUTHORIZING COMMITTEE IS THE
HEALTH EDUCATION, LABOR PENSIONS
COMMITTEE.
THEY DON'T HAVE A LOT OF FUNDED
PROGRAMS.
IT'S NOT LIKE THEY CAN TAKE
SAVINGS SOMEWHERE ELSE SO THE
BUDGET COMMITTEE HAS TO GIVE
THEM AN ALLOCATION FROM SOME
OTHER COMMITTEE IT LET'S A
LITTLE FRAUGHT.
THERE'S LEGISLATION MOVING RIGHT
NOW.
THERE'S NO ACTUAL MONEY ATTACHED
TO IT.
WE HAVE YET TO SEE IF IT WILL
GET TRACTION.
>> I WAS INTERESTED IN SEEING
ALL THE CYBER SECURITY FUNDING
ASSOCIATED.
I WAS CURIOUS, IS THAT MOSTLY
ABOUT PREVENTIVE,
INFRASTRUCTURE, STRENGTHENING
PROCESSES AND SYSTEMS AROUND
SENSITIVE DATA OR IS IT ALSO
ABOUT RESEARCH OR BOTH?
>> THAT WOULD BE ABOUT BOTH.
>> HEAVY EMPHASIS ON THE FORMER
AND TARA SCHWETZ WILL GIVE AN
ENTIRE PRESENTATION ON ARPA-H.
IF WE CAN POSTPONE THAT THAT
WOULD BE THE BEST.
ANY OTHER QUESTIONS AT THIS
POINT BEFORE WE MOVE ON TO THE
LEGISLATIVE --
>> IS THE CHAT ABOUT ARPA-H?
>> WE'LL HAVE AN ENTIRE
PRESENTATION AND LET'S DELAY
THAT QUESTION AND ANSWER UNTIL
WE HEAR THE PRESENTATION.
ADRIENNE, PLEASE.
>> THANK YOU.
DR. TABAK GAVE THE BIRD'S-EYE
VIEW AND THIS IS CLOSER UP SO
YOU KNOW WE HAVE A NUMBER OF
INSTITUTE DIRECTORS ON THE HOT
SEAT.
I THOUGHT IT WOULD BE HELPFUL TO
TALK ABOUT A COUPLE THEMES AND
EVERYONE'S ASKING QUESTIONS
ABOUT ARPA-H.
WE'RE STILL IN THIS PANDEMIC,
POST-
AND ARE WE POST-PANDEMIC AND
CONGRESS IS THERE WITH US AND
THEY'RE ASKING ABOUT LONG COVID
AND ABOUT MENTAL HEALTH, SCHOOL
CLOSURES, MASK POLICIES.
THERE'S STARTING TO BE A GLIMMER
OF LIFE AFTER PANDEMIC GETTING
BACK TO WHAT IS THE FUTURE OF
THE UNDIAGNOSED DISEASES AND
SUCCESS RATE DRIVEN A LOT BY NCI
AND ALZHEIMER'S, ETCETERA.
THAT'S TRUE NOT JUST IN
APPROPRIATIONS.
IN 2020 IT WAS COVID.
WE DID A NUMBER OF EVENTS AND
THERE WASN'T A LOT IN PERSON.
IN 2021, COVID GOT MORE GRANULAR
WHERE IT WAS COVID OR IT WAS
WHAT IS HAPPENING WITH DIVERSITY
IN CLINICAL TRIALS AND RADX.
EVERYTHING HAD A COVID
CONNECTION.
2022 WE'RE STARTING TO SEE
PEOPLE RESUME THEY'RE MORE
TRADITIONAL PRIORITIES.
THEY'RE STILL INTERESTED IN
COVID-19 BUT INTERESTED IN ALS
RESEARCH AND WOMEN'S HEALTH AND
OTHER THINGS.
THAT'S STARTING TO RETURN AND
IT'S A NICE REFRESHER THOUGH WE
WERE ALL IN ON COVID THE REST OF
THE RESEARCH COMMUNITY DID NOT
SO
.
AS DR. TABAK MENTIONED AND
YOU'LL GET A LARGER PRESENTATION
LATER, WE'RE LEGISLATION TO
REQUIRE NOTIFICATION BY
NIH-FUNDED INSTITUTIONS WITHIN
30 DAYS OF REMOVING OR
DISCIPLINARY ACTION.
THIS CAME ABOUT AS PART OF THE
DISCUSSION AROUND SEXUAL
HARASSMENT BUT IT'S IMPORTANT TO
NOTE THIS LANGUAGE DOES NOT SAY
JUST SEXUAL HARASSMENT.
THIS IS HARASSMENT, BULLYING,
RETALIATION, HOSTILE WORK
ENVIRONMENT.
WE'RE TAKING A MORE BROAD
APPROACH TO THIS AS APPROPRIATE.
WE'RE ALSO IMPLEMENTING THE ACT
FOR ALS WHICH WAS ENACTED
RECENTLY.
WE WERE ASKED IN THE OMNIBUS TO
SPEND $25 MILLION IMPLEMENTING
THE POLICY.
THERE'S FIVE SECTIONS TO THE
ACT.
TWO ARE IMPORTANT TO NIH.
ONE IS A PUBLIC-PRIVATE
PARTNERSHIP AND THE SECOND IS A
GRANTS PROGRAM.
A NEW GRANTS PROGRAM FOR
EXPANDED ACCESS TO
INVESTIGATIONAL DRUGS.
ASKING US TO COLLECT DATA FROM
EXPANDED ACCESS.
IT'S A BIT OF A NEW TAKE FOR US
AND IT'S A VERY COMPLICATED
SPACE.
THE BILL IS LIMITED TO SMALL
BUSINESSES UNDER THE SPIR
DEFINITION.
WE'RE RUNNING PHASE 3 CLINICAL
TRIALS.
IT'S A VERY INTRICATE POLICY
SPACE BUT THERE'S MORE TO COME
ON THIS.
I LIKE TO FLAG THINGS TO WATCH
AND THIS IS WHAT WHEN DR. TABAK
IS UP AT NIGHT, THIS KEEPS ME UP
AT NIGHT.
FOR A FEW YEARS NOW WE HEARD
FROM THE LEFT, THE DEMOCRATS,
THERE'S AN INTEREST AT NIH USING
MARGIN TO ADDRESS DRUG PRICING.
WE'RE STARTING TO HEAR FROM THE
RIGHT THERE'S AN INTEREST IN
ROYALTIES PAID TO SCIENTISTS
USING FEDERAL FUNDS.
QUESTIONS ON WHAT'S THE
APPROPRIATE LEVEL OF THOSE
ROYALTIES.
WHERE SHOULD THEY BE GOING AND
USED FOR.
SINCE WE'RE NOW SEEING FROM THE
LEFT AND RIGHT BOTH YOUGROUPS
SAYING SHOULD WE AMEND THE
POLICIES?
THERE'S MOMENTUM.
IT'S NOT BIG YET BUT WE'RE
WATCHING THE SPACE AND SOMETHING
PROFESSIONAL SOCIETIES ARE
WATCHING.
FUTURE FORECAST.
THIS IS GOING TO BE A TIGHT
YEAR.
WE'LL TALK ABOUT WHAT THE
CALENDAR LOOKS LIKE AND WHAT
MIGHT HAPPEN.
THIS YEAR THERE'S TWO BIG
EXPLORATIONS.
FDA USER FEES.
THIS IS HOW FDA THEIR WORK.
THESE ARE FEE-AUTHORITY EXPIRES
SEPTEMBER 30, TO NOT LAYOFF
STAFF THEY HAVE TO KNOW WELL
BEFORE SEPTEMBER 30.
THE FDA USER FEE LEGISLATION IS
MOVING NOW.
BECAUSE IT'S A MUST-PASS BILL IT
MAY HAVE PROVISIONS PEOPLE
ATTACH BECAUSE THEY KNOW THE
USER FEES WILL MAKE IT TO THE
PRESIDENT'S DESK.
OUR PROGRAMS ARE SUN SETTING AT
THE END OF THE FISCAL YEAR,
SEPTEMBER 30.
WE'LL MAKE ALL OUR AWARDS UNDER
EXISTING POLICIES.
WE'RE LOOKING TO SEE WHETHER
THERE WILL BE CHANGES.
I DON'T KNOW IF PEOPLE STOP
FUNDING IN AN ELECTION YEAR BUT
IT'S SOMETHING WE'RE TAKING A
LOOK AT.
APPROPRIATIONS HAVE TO GET DONE.
THERE'S AN ANNUAL DEFENSE
AUTHORIZATION AND ALSO IN ONE OF
THE COVID BILLS THERE WAS A
SUPPLEMENTAL SUBSIDY FOR
INCREASES TO PREMIUMS.
THAT IS EXPIRING.
WITHOUT AN EXTENSION THERE COULD
BE A DRAMATIC INCREASE IN
PREMIUMS.
THOSE ARE SOME PROVISION WILL
HAVE TO PASS THIS YEAR.
IN THE MIDST OF THAT THERE'S
LEGISLATION SWIRLING THAT MIGHT
PASS AND MAY GET ATTACHED TO THE
MUST PASS.
THINGS WE CARE ABOUT AND WE'RE
WATCHING THE ARPA-H
AUTHORIZATION.
SOME SORT OF HEALTH OMNIBUS,
PANDEMIC PREPAREDNESS, CURES
2.0.
A LOT OF THAT HAS TO DO WITH
THERE'S A LOT OF PRESSURE RIGHT
NOW TO EXPAND THE POLICIES
AROUND TELEHEALTH AND REMOTE
HEALTH CARE.
WHAT DID HEALTH CARE LOOK LIKE
IN THE PANDEMIC AND WHAT ARE THE
LESSONS LEARNED WE CAN MAKE
PERMANENT.
THERE'S ALL THESE THINGS THAT
ARE KIND OF SWIRLING.
IT FEELS TO ME LIKE THIS IS ONE
OF THOSE WHERE INDIVIDUAL BILLS
ARE NOT GOING TO MOVE ON THEIR
OWN.
THERE WILL BE A PACKAGE AT SOME
POINT POSSIBLY MORE THAN ONE.
U.S. COMPETES ACT.
THIS IS MOSTLY AN NSF BILL.
THERE'S A LOT OF PRESSURE TO
MOVE IT BECAUSE THERE'S MONEY TO
BRING THE SEMICONDUCTOR INDUSTRY
BACK TO SHORES.
THAT'S THE U.S. COMPETES ACT BUT
THERE ARE PROVISIONS THAT RELATE
TO NIH CURRENTLY IN THE SENATE
VERSION OF THE COMPETE ACT AND
WE'RE WATCHING THAT AS IT GETS
NEGOTIATED.
AND A LOT OF THESE HAVE TO DO
WITH POLICY MAKERS REACTING TO
MANY OF THE CONTROVERSIES, MANY
OF THE CONSPIRACY THEORY SWIRL
DURING THE PANDEMIC.
THERE'S A LOT OF CONVERSATION
ABOUT ENHANCED PATHOGENS AND
POTENTIAL PATHOGENS.
I GET THAT PHRASE WRONG ALL THE
TIME.
THERE'S CONVERSATION ABOUT
INTERNATIONAL RESEARCH.
POSSIBLE RESTRICTIONS.
AND THERE'S PERMUTATIONS OF THE
LANGUAGE AND WE'RE WATCHING ALL
OF IT IF WE GET OUT OF THIS
CALENDAR YEAR WITHOUT SOME KIND
OF POLICY BEING MADE, NEXT YEAR
THIS WILL COME BACK.
THIS WILL BE AN ONGOING THERE'S
A LOT OF STEPS FROM THE POINT
WHERE THE PRESIDENT ANNOUNCE D
THEY HAVE TO DO MEETINGS AND
THERE HAS TO BE AT LEAST TWO
VOTES.
IF YOU LOOK AT THE CALENDAR,
WE'RE IN JUNE, THE YELLOW IS
WHERE BOTH THE HOUSE AND SENATE
ARE IN SESSION, THE BLUE IS
WHERE THE SENATE ONLY IS IN
SESSION AND THE ORANGE IS WHERE
ONLY THE HOUSE IS.
CONFIRMATION ONLY GOES TO THE
SENATE.
WE'VE GOT TIME IN JUNE AND JULY.
WE DON'T HAVE ANNOUNCEMENTS FOR
OSTP OR NIH.
ALL THOSE BILLS I WAS TALKING TO
YOU ABOUT BOTH BODIES HAVE TO BE
IN.
SO JUNE, JULY -- WE'RE GOING TO
DO A LOT OF WORK.
THE CONGRESS WILL DO A LOT OF
WORK IN JUNE AND JULY.
AUGUST THERE'S A RECESS.
SEPTEMBER YOU HAVE ABOUT THREE
WEEKS.
MOSTLY THEY'LL BE WORKING ON
KEEPING THE GOVERNMENT FUNCTIONS
BUT I THINK THE HEALTH OMNIBUS'
COULD PASS IN JULY.
THEN YOU GET TO OCTOBER AND
NOVEMBER.
THE SENATE SAYS THEY'LL BE IN
TWO WEEKS IN OCTOBER LEADING UP
TO THE ELECTION, WE'LL SEE.
THEY MAY HAVE TO TO GET SOME
CONFIRMATIONS THROUGH.
IT WILL BE TIGHT.
IN THE FALL IN NOVEMBER, THEY'RE
GOING TO BE THINKING ABOUT
ORGANIZING THEMSELVES FOR THE
NEW CONGRESS IN JANUARY.
THAT BRINGS US TO THE ELECTION.
RETIREMENT WATCH.
THERE'S A NUMBER OF RETIREMENTS
WHICH WAS TRUE TWO YEARS AGO.
WE'RE SEEING A GENERATIONAL
SHIFT IN CONGRESS.
SO FAR 33 DEMOCRATS AND 23
REPUBLICANS ANNOUNCED THEY'RE
RETIRING.
SOME LIKE THE GENTLEMEN
MENTIONED HERE ARE VERY SENIOR
AND IN VERY POWERFUL POSITIONS
RELATED TO NIH.
I'M NOT A PUNDIT SO THERE'S
SMARTER PEOPLE OUT THERE BUT TO
LET YOU KNOW, VOTER TURNOUT WAS
ESPECIALLY HIGH IN 2018.
WHAT WILL HAPPEN IN 2022.
THESE ARE MIDTERM ELECTIONS SO
TURN OUT IS A BIG PART OF THE
STORY.
IN THE PAST YEAR THERE'S RECORD
HIGH CAMPAIGN SPENDING FOR AN
OFF-CYCLE YEAR.
NOT ONLY ARE PEOPLE RAISING
MONEY IN RECORD AMOUNTS, THEY'RE
SPENDING MONEY IN RECORD
AMOUNTS.
CONTROL SUP -- IS UP FOR GAPS.
IF YOU LOOK AT THE LAST 15, 20
YEARS, THE NUMBER OF COMPETITIVE
DISTRICTS IN GRAY IN THE MIDDLE
HAS GONE DOWN AND DOWN.
THE BRIGHT COLORS ARE THE SOLID
DISTRICTS.
THEY'RE GOING TO STAY.
BUT THAT MEANS THAT PRIMARIES
ARE INCREDIBLY IMPORTANT.
EVERYBODY KNOWS THAT.
THIS IS JUST TO LET YOU KNOW,
THE REPUBLICAN PARTY IS TARGET
BEING MORE SEATS.
THEY'RE IN THE MINORITY IN THE
HOUSE AND SENATE.
IT'S NOT TERRIBLY SURPRISING.
YOU'RE GOING TO SEE 40 SEATS ARE
HIGHLY COMPETITIVE AND THAT'S
WHERE A LOT OF THE ATTENTION ON
ELECTION NIGHT WILL BE PAID.
RIGHT NOW THESE ARE THE OPEN
SEATS IN THE SENATE.
OF THOSE REQUIREMENTS, THESE ARE
THE ONES THAT ARE HAPPENING IN
THE SENATE CLASS.
ONLY A THIRD OF THE SENATE IS UP
EVERY TWO YEARS.
THEIR TERMS ARE SIX YEARS.
DEMOCRATS ARE DEFENDING ONE
SEAT.
THERE ARE SIX OPEN SEATS ON THE
REPUBLICAN SIDE.
THAT'S WHAT WE'RE WATCHING FOR.
IT'S GOING TO BE A BUSY SUMMER
AND IT'S GOING TO BE A VERY
FALL.
>> QUESTIONS FOR ADRIENNE AT
THIS POINT?
I'M NOT SEEING ANY.
I GUESS IT WAS PERFECTLY CLEAR.
>> I DESERVE A RAISE.
>> THANK YOU, ADRIENNE AND NEIL.
I'D LIKE TO GIVE YOU SOME VERY
RAPID UPDATES AND SAMPLING OF
INITIATIVES THAT NIH HAS
UNDERTAKEN.
FIRST THE CANCER MOON SHOT.
SOME MAY RECALL IT WAS LAUNCHED
IN 2016 BY THEN VICE PRESIDENT
BIDEN WITH A GOAL OF
ACCELERATING CANCER PROGRESS
INTO THE TRANSLATION OF SPACE
NCI'S INVESTED OVER $1 BILLION
OF MOON SHOT AND SUPPORTED
RESEARCH PROJECTS OVER 70 CANCER
SCIENCE INITIATIVES.
THERE'S A FEW ACCOMPLISHMENTS.
THE FIRST THREE YEARS OF THIS
OVER 1200 PUBLICATIONS.
AND PRESIDENT BIDEN ANNOUNCED
PLAN TO REIGNITE THE MOON SHOT
TO END CANCER AS WE KNOW IT.
IN ORDER TO REDUCE CANCER
MORTALITY THERE'S NO SINGLE WAY
OF DOING THAT.
IT'S GOING TO REQUIRE A FOCUS ON
MANY THINGS ON PREVENTION AND
SCREENING, TOBACCO CONTROL AS
WELL AS THERAPIES THE NEXT PHASE
OF THE MOON SHOT IS FOCUSSING ON
HOW PEOPLE EXPERIENCE CANCER
TODAY.
PREVENTION AND EARLY DETECTION
AND I ENJOYED PART OF THE FIRE
SIDE CHAT WITH THE DIRECTOR OF
THE NATIONAL INSTITUTE ON DRUG
ABUSE AND DR. BAKER, DIRECTOR OF
THE HEAL INITIATIVE.
AND DURING THIS TALK WE REALLY
DISCUSSED THE LATEST PROGRESS
AND CONTINUED CHALLENGES AND NIH
ADDRESSING THE OPIOID CRISIS.
A BIG PART OF THE EFFORT IS
THROUGH THE HEAL INITIATIVE.
ONE MAJOR GOAL HAS BEEN TO
DISCOVER AND VALIDATE NOVEL
TARGETS FOR SAFE AND EFFECTIVE
NON-ADDICTIVE PAIN MEDICINE.
AND THERE'S PATENTS TO TREAT
CHRONIC PAIN AND MIGRAINES AND
AN IND FOR FIRST IN CLASS,
NON-ADDICTIVE CANDIDATE FOR
TREATING PAIN.
OVER 50 THERAPIES ARE BEING
INVOLVED.
23 INDs AND A STUDY OF OPIOID
VACCINE IS ONGOING.
USING DEVICES TO TREAT PAIN IN
OPIOID USE DISORDER.
THIS IS THE VICE PRESIDENT'S
CABINET MEETING PLAN.
THE MATERNAL DEATH RATE IN THE
U.S. HAS RISEN NEARLY 37% SINCE
2018.
THIS CRISIS IS PARTICULARLY
ACUTE AMONG BLACK WOMEN WHO ARE
THREE TIMES MORE LIKELY TO DIE
FROM A PREGNANCY-RELATED
COMPLICATION AS WHITE WOMEN
REGARDLESS OF INCOME OR
EDUCATION.
THE ADMINISTRATION IS DEVELOPING
A NATIONAL STRATEGY THAT
INCLUDES COMMITMENTS FROM
AGENCIES ACROSS THE GOVERNMENT.
AT THE MEETING, DR. BIANCHI AND
I WERE PRIVILEGED TO JOIN THE
OVER ALL TEAM TO DISCUSS NIH'S
ROLE.
AND INCLUDING SUPPORT AND
BUILDING THE NEXT GENERATION OF
MATERNAL HEALTH RESEARCHERS
WHICH IS VERY IMPORTANT.
WE'RE WORKING TO INCREASE
PARTICIPATION OF UNDER
REPRESENTED RESEARCHERS IN THIS
AREA.
THERE'S A LOCI SUPPORTING
RESEARCH FOCUSSED ON REDUCING
PREVENTIBLE CAUSES AND WORKING
WITH THE INDIVIDUAL BEFORE,
AFTER AND DURING DELIVERY AND A
SPECIAL EMPHASIS ON THE HEALTH
DISPARITIES BEING OBSERVED IN
MATERNAL HEALTH COMMUNITY.
ONE EXAMPLE OF AN ACCOMPLISHMENT
TO DATE IS THE APPROVAL BY THE
FDA TO TREAT PAIN ASSOCIATED
WITH ENDOMETRIOSIS.
A DEVASTATING CONDITION.
A QUICK SNAPSHOT OF WHERE THE
ALL OF US PROGRAM IS.
AS WE APPROACH THE MILESTONE OF
NEARLY 500,000 CONSENTED
PARTICIPANTS, MORE THAN 338,000
HAVE COMPLETED ALL THE INITIAL
STEPS TO SHARE THEIR DATA WHICH
IS NOW AVAILABLE IN THE
RESEARCHER WORK BENCH BEING USED
BY OVER 2200 RESEARCHERS.
ELECTRONIC HEALTH RECORDS ON LAB
MEASURES AND DRUG EXPOSURES.
SOME EXTEND BACK DECADES OR MORE
AS YOU CAN SEE BY THE PLOT.
PHYSICAL MEASURES AND FITBIT
DATA ARE RELATIVELY NEW TO THE
GAME BUT ROBUST IN MEMBERS WHO
CONTRIBUTED THESE.
WE WILL LAUNCH PEDIATRIC ENROLL
MANY IN THE FUTURE BUT AS A
RESULT OF THE EXTENSIVE HEALTH
RECORD COLLECTION, WE ALREADY
HAVE DATA ON SOME PARTICIPANTS
WHICH MAKES FOR INTERESTING
OPPORTUNITIES.
THIS MARCH WE RELEASED ALMOST
100 WHOLE GENOME SEQUENCES AND
IF I CAN HAVE THE NEXT SLIDE
THIS IS IMPORTANT FIGURE.
IT UNDER SCORES THAT UP UNTIL
NOW, OVER 90% OF PARTICIPANTS
FROM LARGE GENOMIC STUDIES HAVE
BEEN OF EUROPEAN DESCENT IN THE
GRAY BARS.
THE LACK OF DIVERSITY IN
RESEARCH HAS HINDERED SCIENTIFIC
OPPORTUNITIES.
IN THE FIRST RELEASE OF NEARLY
100,000 GENOME SEQUENCE, ALL OF
US ARE CONTRIBUTING TO THE
GLOBAL DIVERSITY OF DATA WITH
80% OF PARTICIPANTS COMING FROM
BACKGROUNDS UNDER REPRESENTED IN
BIOMEDICAL RESEARCH AND OTHER
RACE AND ETHNICITY.
AS A RESULT WE'RE OBSERVING MORE
UNIQUE VARIANTS MORE THAN 593
MILLION INCLUDING 193 MILLION
VARIANTS WITH THREE OR MORE
OCCURRENCES THAT HAVE NOT BEEN
SEEN.
OUR PARTICIPANTS ARE LEADING THE
WAY TO MORE REPRESENTATION IN
MEDICAL RESEARCH.
OVER TIME AS WE EXPAND DATA AND
NEW TOOLS WE HOPE THE DATA SET
IS GOING TO PROVIDE ENDLESS
POSSIBILITIES FOR DISCOVERY TO
UNDERSTAND THE ROLE OF GENES,
VARIANTS AND OTHER FACTORS THAT
COMBINE TO EFFECT HEALTH AND
DISEASE.
DAVID IS POINTING OUT THERE'S
ANOTHER ROLE RELEASED QUITE SOON
WHICH WILL MORE THAN DOUBLE THE
NUMBER WHICH IS QUITE
REMARKABLE.
WE'LL COME BACK TO YOUR
QUESTION.
WHY DON'T YOU DO IT NOW.
THEN WE'LL GO TO GARTH'S
QUESTION.
SHELLY, A QUESTION?
>> YES, THANK YOU.
MY QUESTION WAS DAVID ANSWERED
WHAT WAS COMING UP.
WHAT PERCENTAGE IN WHAT WE HAVE
SO FAR IS FEMALE.
THE DIFFERENCE IN MOUSE STUDIES
IS DRAMATIC IN SOME AREAS OF THE
DIFFERENCE BETWEEN FEMALE AND
MALE RESPONSES.
I WAS CURIOUS WHAT THE OBJECTIVE
AND CURRENT STATE IS.
>> THIS IS BALANCED.
WE CAN GET A SPECIFIC BREAK DOWN
FOR YOU.
>> CIRCLING BACK TO GARTH'S
QUESTION, IS THE MATERNAL HEALTH
INITIATIVE, TRANS-NIH, TARA,
WOULD YOU LIKE TO COMMENT ON
THAT?
I DON'T THINK WE HAVE DIANA YET.
>> THE INITIATIVE IS IMPROVE.
IT IS A TRANS-NIH EFFORT AND
IT'S OVER 10 AT THIS POINT.
>> THERE'S NATIVE AND AMERICAN
ASIAN REPRESENTATION.
THE PARTICIPATION OF NATIVE
AMERICANS IN STUDIES OF THIS
TYPE CAN RAISE ISSUES AT THE
TRIBAL LEVEL.
WE HAVE DOWN EXTENSIVE WORK
CLOSELY WITH TRIBAL LEADERS
ACROSS THE COUNTRY.
AND ATUL IS PUTTING THE MOST
RECENT PARTICIPANT DASHBOARD
HERE.
THIS IS IN REGARD TO NATIVE AND
ALASKAN NATIVES.
WE HAVE TO DO THIS AS GARY
GIBBONS WOULD SAY LIKE AT THE
SPEED OF TRUST.
SO WE'RE WORKING THROUGH THOSE
ISSUES.
I KNOW -- AND GARTH HAD A
QUESTION.
ANY OTHER IN THERE I'VE MISSED?
THANK YOU FOR YOUR
CONTRIBUTIONS.
THIS RIBBON-CUTTING CEREMONY HAS
IMPORTANCE.
I WAS PLEASED TO JOIN
DR. GILLMAN AND DR. SCHWETZ AND
OTHERS TO INITIATIVE THE OPENING
OF THE NEW CLINICAL CENTER
OUT-PATIENT PHARMACY.
WE ARE MOSTLY ELIMINATING ERRORS
AND SO MUCH AUTOMATION.
AS A RESULT WE THINK WE'LL BOOST
THE MORALE OF THE STAFF OF FOLKS
THAT WORK HERE.
I DON'T KNOW IF ALFRED OR TARA
WOULD LIKE TO COMMENT ON THIS.
I KNOW YOU HAVE ALL BEEN
INVOLVED WITH THIS.
>> IT'S IMPRESSIVE AND
OPTIMISTIC TO SEE.
THERE'S IMPROVED SAFETY AND
EFFICIENCY.
>> STAFF HAS BEEN WAITING FOR A
LONG TIME AND WAITING AND HAPPY
TO HAVE THIS IN WHAT THEY FEEL
SAY MUCH MORE PROFESSIONAL
ENVIRONMENT.
>> THANK YOU BOTH.
THANKS TO THE CLINICAL CENTER
STAFF AND ALL WHO MADE IT
HAPPEN.
I HAD THE PRIVILEGE WITH
DR. ELISEO PEREZ-STABLE WHEN
PRESIDENT BIDEN SIGNED THE NIHMB
REVITALIZATION ACT OF 2021.
-- NIMHD.
AND THIS ENDOWMENT PROGRAM
PROVIDES FUNDING TO THE
ENDOWMENT OF ACADEMIC
INSTITUTIONS WITH THE GOAL TO
HELP BUILD INFRASTRUCTURE AND
CAPACITY TO PROMOTE MINORITY
HEALTH AND HEALTH DISPARITIES
RESEARCH AND INSTITUTIONS THAT
HAVE LIMITED ENDOWMENTS.
INITIALLY AIMS TO ENHANCE
RECRUITMENT FROM POPULATIONS
UNDER REPRESENTED IN BIOMEDICAL
RESEARCH AND PROMOTE TRAINING IN
THE FIELD OF MINORITY HEALTH AND
HEALTH DISPARITY RESEARCH.
WHAT'S UNIQUE ABOUT THIS IS THIS
DOES NOT DIRECTLY FUND RESEARCH
PROGRAMS BUT AWARDS
INSTITUTIONS, RESOURCES FOR THE
ENDOWMENT THAT MUST BE INVESTED
AND MAINTAINED FOR AT LEAST 20
YEARS AFTER THE AWARD PERIOD
ENDS.
AND GRANTEES MUST PROVIDE A
FIVE-YEAR STRATEGIC PLAN THAT
ESTABLISHES THE PRIORITIES FOR
THE USE AND GROWTH OF THE
ENDOWMENT INCOME.
THE NEW ACT EXPANDS ELIGIBILITY
FOR THE PROGRAM TO INCLUDE BOTH
FORMER NIMHD AND HRSA CENTERS OF
EXCELLENCE.
THIS SLIDE SUMMARIZES THE BILL
AND MELINDA GATES FOUNDATION
COLLABORATION.
WE HAD THE ANNUAL HEALTH LECTURE
AT THAT TIME NIH AND BILL AND
MELINDA GATES LAUNCHED THE
NATURAL PARTNERSHIP HAVE
OCCURRED REPRESENT 57% OF GLOBAL
HEALTH R&D AND SHARE MULTIPLE
CLINICAL AND RESEARCH
PRIORITIES.
COVID INFECTION RATES
PERMISSIBLE, WE'LL HAVE OUR
ANNUAL MEETING THIS DECEMBER
HOSTING MR. GATES AND THE
FOUNDATION SENIOR LEADERSHIP AND
SCIENTIFIC STAFF.
THIS PARTICULAR SLIDE HIGHLIGHTS
SEVERAL JOINT PROJECTS WE THINK
COULD BE GAME CHANGERS IN HIV.
NEUTRALIZING GLOBAL ANTIBODIES
AND HUMAN PAPILLOMA VACCINES AND
IMPROVE HPV VACCINATION COVERAGE
BY REDUCING COST AND SIMPLIFYING
ADMINISTRATION.
A NOVEL TB VACCINE TO STOP
LATENT TB FROM BECOMING ACTIVE
AND THE HIV SICKLE CELL THESE
AIMED AT ADVANCING LOW-COST
DELIVERY SYSTEMS BASED ON GENE
THERAPY CANDIDATES FOR SICKLE
CELL AND HIV.
FINDING WAYS TO ELIMINATE THE
RESERVOIRS OF HIV, HOW TO
DEVELOP SAFE GENE DELIVERY
SYSTEMS WITH A FOCUS ON NANO
PARTICLES THAT SCALE TO WHAT IS
REQUIRED.
THEN OF COURSE TO BETTER
UNDERSTAND THE SAFETY SYSTEMS
AND GENE THERAPY TRIALS TO
IMPROVE WAYS OF MONITORING THESE
EFFORTS.
THIS SAY SUMMARY OF ENORMOUS
EFFORT OF THE HUMAN HEREDITARY
PROGRAM WHICH EXPLORE GENETIC
CONTRIBUTORS TO DISEASES.
THIS IS SUPPORTED BY THE NIH
COMMON FUND AND THE WELCOME
TRUST.
HD AFRICA HAS FUNDED OVER 50
PROJECTS IN MORE THAN 30
COUNTRIES.
MANY ACHIEVEMENTS INCLUDING OVER
100,000 PARTICIPANTS.
50,000 SAMPLES OF GENOTYPE, 26
CORE PHENOTYPES IDENTIFIED.
IN ADDITION TO STANDING THIS UP
THE CONSORTIUM CREATED
REPOSITORIES IN NIGERIA, UGANDA
AND SOUTH AFRICA AND SHARE
COMMON METHODOLOGIES AND HOUSE
DNA SAMPLES.
TURNS OUT ONE OF THE MOST
REQUESTED DATA SETS IS FROM
ANALYSIS OF 426 PARTICIPANTS
COMPRISING GROUPS INCLUDING
PREVIOUSLY UNSAMPLED POPULATION.
A RESEARCH TEAM ON THIS PROJECT
UNCOVERED MORE THAN 3 MILLION
PREVIOUSLY UNKNOWN VARIANTS.
THIS IS DESCRIBED IN A NATURE
PAPER.
IF SOMEBODY CAN PUT THAT IN THE
CHAT BOX I'D APPRECIATE THE LINK
TO THAT.
BRIEFLY AND NIH EFFORTS TO
ADDRESS HARASSMENT OF ALL TYPES
INCLUDING SEXUAL HARASSMENT.
CONGRESS STRENGTHENED OUR
ABILITY TO ADDRESS HARASSMENT.
IT'S BEEN OUR GOAL TO ENSURE
SCIENCE CONDUCTED IN A SAFE
WORKPLACE AND FOLLOWING THE 2018
NATIONAL ACADEMIES REPORT, WE
HAVE REALLY ELEVATED OUR EFFORTS
TO END SEXUAL HARASSMENT IN
BIOMEDICAL RESEARCH.
UP TO NOW WE HAVE EXPECTED BUT
NOT REQUIRED INSTITUTIONS NOTIFY
US OF CERTAIN CIRCUMSTANCES AND
WE ENCOURAGE ALL STAKEHOLDERS TO
REPORT THEIR CONCERNS ABOUT
HARASSMENT AT NIH THROUGH THE
OFFICE OF EXTRAMURAL RESEARCH.
THANKS TO CONGRESS AND I MUST
SAY THIS WAS TIRELESS EFFORT ON
THEIR PART WITH THE PASSING OF
SECTION 239 OF THE '22 OMNIBUS,
WE NOW HAVE A NEW TOOL WHERE
SOMEBODY NAMED AS A KEY
PERSONNEL ON A GRANT IS REMOVED
FROM THEIR POSITION OR OTHERWISE
DISCIPLINED FOR HARASSMENT,
BULLYING OR RETALIATION OR
HOSTILE WORK CONDITIONS AND IT
GOES INTO EFFECT IN JULY AND
WE'RE GRATEFUL TO CONGRESS FOR
PROVIDING THIS.
MIKE, ARE YOU ON THE CALL?
>> YES, I AM.
>> WALK US THROUGH THE DATA.
IT'S YOUR DATA.
>> THIS IS DATA ON THE
HARASSMENT AND HOSTILE WORK
ENVIRONMENT COMPLAINTS WE HAVE
RECEIVED SINCE WE STARTED DOING
THIS AT A HIGHER LEVEL BACK IN
2018.
WE'RE SHOWING THE NUMBER OF
COMPLAINTS WE RECEIVED IN EACH
YEAR.
THESE ARE CALENDAR YEAR DATA AND
THE DATA ARE THROUGH I BELIEVE
THE END OF APRIL, BEGINNING OF
MAY.
SO WE'RE AT PACE NOW TO GET AT
LEAST AS MANY COMPLAINTS THIS
YEAR ASKED IN YEARS PAST.
YOU CAN SEE IN 2021, WE RECEIVED
160 COMPLAINTS.
WE'RE UP TO OVER 480 BY NOW.
ONE THING THAT'S INTERESTING IS
THE PROPORTION OF CASES THAT ARE
SEXUAL HARASSMENT OPPOSED TO
OTHER TYPES OF ISSUES.
SO YOU CAN SEE THAT BACK IN
2018, 2019, MOST CASES WERE
SEXUAL HARASSMENT OR SEXUAL
HARASSMENT ONLY.
NOW WHAT HAS HAPPENED IS THE
MAJORITY OF OUR CASES ARE NOT
SEXUAL HARASSMENT, THEY'RE
NON-SEXUAL HARASSMENT, BULLYING
OR DISCRIMINATION OR OTHER FORMS
OF HOSTILE WORK CONDITIONS.
THESE ARE OUTCOMES FOR SEXUAL
HARASSMENT AND HAVE OTHER DATA
ON THE OUTCOMES FOR HARASSMENT
OR FOR NON-SEXUAL HARASSMENT.
WHAT THIS SHOWS YOU IS THAT THE
TOTAL NUMBER -- THE VAST
MAJORITY OF CASES WE CONTACT
INSTITUTIONS AND THERE'S
TYPICALLY SOME KIND OF FORMAL
INVESTIGATION WHICH IS
UNDERTAKEN BY THE INSTITUTION.
ABOUT ONE-QUARTER TO ONE-THIRD
OF THE TIMES THE ALLEGATIONS ARE
SUBSTANTIATED.
THIS MAYBE A BIT OF AN UNDER
ESTIMATE BECAUSE IN SOME CASES A
SCIENTIST MAY LEAVE AN
INSTITUTION OR OTHERWISE RESIGN
AND THEN THE INVESTIGATION
DOESN'T CONTINUE SO NO FORMAL
FINDINGS MAY BE MADE.
WE HAD A SUBSTANTIAL NUMBER OF
CASES WHERE PRINCIPLE
INVESTIGATORS HAVE BEEN REMOVED
OR OTHER GRANT ACCESS TAKEN LIKE
ADDITIONAL MONITORING.
WE'VE HAD A NUMBER OF CASES
WHERE INVESTIGATORS HAVE LEFT
THE INSTITUTION IN THE MIDDLE OR
A RESULT OF AN INVESTIGATION AND
REMOVED PEOPLE FROM PEER-REVIEW
WHICH WE HAVE THE DISCRETION TO
DO.
THAT'S IT.
>> GREAT.
THERE'S QUESTIONS IN THE CHAT
BOX.
GARTH IS ASKING IF YOU HAVE
BREAK DOWNS BY DEMOGRAPHICS?
>> WE DO.
OFF THE TOP OF MY HEAD, WHAT I
DO REMEMBER IS THE VAST MAJORITY
INVOLVE MEN AND INVOLVE
EXPERIENCED INVESTIGATORS.
FOR THE NON-SEXUAL HARASSMENT
THEY'RE BOTH SUBSTANTIAL NUMBERS
OF MEN AND WOMEN WE'RE LINKING
WITH ADMINISTRATIVE DATA TO GET
A BETTER SENSE OF WHAT THIS
LOOKS LIKE.
>> WHAT MIKE JUST REPORTED IS
EXTRAMURAL EFFORTS.
WE HAVE EXTRA DATA SO ARE YOU
INTERESTED IN THE NIH WORKFORCE?
>> YOU ANSWERED MY QUESTION.
THIS IS EXTRAMURAL.
BASICALLY THE QUESTION IS WHAT'S
THE PERCENT OF THE TOTAL
POPULATION THAT IS UNDER STUDY
THAT EXHIBITS THIS BEHAVIOR?
IS IT 1%, 20%?
IT'S IMPORTANT TO KEEP IN
PERSPECTIVE.
>> THE NUMBERS THAT MIKE SHARED
WITH YOU AND KEY PERSONNEL IS A
TINY FRACTION AND NO FRACTION IS
APPROPRIATE YOU HAVE TO KEEP IT
IN PERSPECTIVE.
HOWARD IS ASKING, ONCE WE'RE
INFORMED ARE THERE UNIFORM
PROCEDURES FOR FOLLOW-UP OR
ACTION?
>> THE ANSWER TO THAT IS YES.
I WILL PUT INTO THE CHAT A PAGE
WEB PAGE WHERE WE DESCRIBE OUR
SOPs IN DETAIL.
>> WHAT HAPPENS TO A P.I. ONCE
THEY LEAVE, IT'S VERY DEPENDENT
UPON INSTITUTIONAL APPROACH.
>> I UNDERSTAND.
I GUESS MY QUESTION WAS SIMILAR
TO HOWARD'S IN A SENSE IF IT'S A
GRANT, WHAT I'M TAKING AWAY IS
WHAT HAPPENS TO THE GRANTS.
I WONDERED IF THERE'S FOLLOW-UP
IF SOMEONE WERE TO LEAVE TO
FOLLOW-UP TO MAKE SURE THAT
THERE'S SOME SORT OF SCRUTINY
ABOUT GRANTS.
>> SO AGAIN, TYPICALLY WE TRY
AND KEEP THE GRANTS AND TRANSFER
TO ANOTHER QUALIFIED P.I.
OTHERWISE YOU COULD BE
ENDANGERING THE CAREERS OF
PEOPLE WITHIN THE LABORATORY
ENVIRONMENT.
THESE ARE CASE BY CASE.
>> MAYBE --
>> NIH DOES NOT HAVE THE ABILITY
TO DEBAR OR SUSPEND A SCIENTIST
BUT WE HAVE A BUILT TO REFER FOR
DEPARTMENT AND SUSPENSION.
WE HAVE MADE SOME REFERRALS
BECAUSE OF HARASSMENT MATTERS.
>> GREAT.
THANK YOU.
I'M BEING REMINDED BY TARA I'M
GOING OVER TIME.
LET'S LET ATUL'S QUESTION BEING
THE LAST ON THE TOPIC AND HAVE
THINGS FOR CONSIDERATION.
>> WE'VE HAD A SMALL NUMBER OF
CASES WHERE IT'S A GRADUATE
STUDENT HARASSING SOMEBODY ELSE
OR A TECHNICIAN HARASSING
SOMEBODY ELSE AND THE PROBLEM IS
THE P.I. OR UNIVERSITY IS NOT
HANDLING IT PROPERLY.
WE HANDLE THOSE CASE AS
ACCORDING TO OUR SOP BECAUSE AN
UNSAFE ENVIRONMENT IS AN UNSAFE
ENVIRONMENT EVEN FROM IF THE
APPROXIMATE CAUSE ISN'T THE KEY
PERSONNEL.
THOSE ARE CASES WE DEAL WITH.
>> SO THIS IS GOING TO BE
UNCOMFORTABLE TO MANY OF YOU BUT
ONE THING THAT KEEPS ME UP AT
NIGHT IS INCREASINGLY NIH
RESOURCES ARE BEING CONCENTRATED
IN FEWER AND FEWER INSTITUTIONS
AND THE TOP 20 MAY BECOME THE
ONLY 20 IF WE'RE NOT CAREFUL.
I SHOULD STATE UP FRONT MY
BIASES.
SOME OF YOU KNOW I'M A GRADUATE
OF THE CITY COLLEGE OF NEW YORK.
I HAVE QUIPPED ON MORE THAN ONE
OCCASION WHEN I MOVED FROM A
SCHOOL IN BUFFALO NEW YORK TO A
MEDICAL SCHOOL IN NEW YORK I
WENT FROM OKAY TO BEING A GENIUS
AND I THINK THIS CONCENTRATION
OF RESOURCES IS REALLY SOMETHING
THAT I WORRY A GREAT DEAL ABOUT.
I KNOW I DID POOR TIME
MANAGEMENT HERE AND HOPEFULLY
WE'LL HAVE SPARE TIME LATER AND
IN THE MEETING TO COME BACK TO
IT, BUT THAT'S THE FIRST THING I
WANTED TO RAISE TO THE COUNCIL
AS SOMETHING I WORRY ABOUT.
THE OTHER THING I WORRY ABOUT IS
MISINFORMATION IN AND AROUND
SCIENCE.
THE FACT THAT THERE'S A LACK OF
TRUST IN SCIENCE BY SO MANY
PEOPLE TODAY -- AND THIS IS NOT
A NEW PHENOMENON BUT SEEMS TO BE
SPREADING IN A VERY MALIGNANT
SORT OF WAY.
THIS TOO BOTHERS ME A GREAT
DEAL.
I DON'T WANT TO MAKE TOO MUCH OF
A CONNECTION BETWEEN THESE TWO
OBSERVATIONS BUT IF YOU
CONCENTRATE MUCH OF THE
SCIENTIFIC EFFORT IN A VERY
SMALL NUMBER OF INSTITUTIONS,
THE OPPORTUNITY FOR LOCAL
COMMUNITIES TO EMBRACE AND
ENGAGE WITH WORKING SCIENTISTS
IS LESSENED.
I DON'T MEAN TO IMPLY IT'S
CAUSAL BUT EVEN IF THERE'S NO
LINK AT ALL, THESE ARE TWO
IMPORTANT ISSUES.
I DO WORRY ABOUT THEM.
OKAY.
I AM SENSITIVE TO THE TIME.
I DON'T KNOW IF ANYONE WANTS TO
MAKE A QUICK COMMENT OR TWO OR
IF YOU'RE ALL IN THE NEED OF A
BIO BREAK, WHICH SUPPOSED TO
HAVE STARTED TWO MINUTES AGO, I
APOLOGIZE FOR BEING OVER.
ANY COMMENTS OR QUESTION?
>> I AGREE WITH YOU THE TWO
ISSUES ARE CRITICAL AND
POTENTIALLY LINKED.
>> ANY OTHER QUICK COMMENTS
BEFORE WE BREAK?
>> THE THINGS KEEPING YOU UP AT
NIGHT I THINK ARE KEEPING US ALL
UP AT NIGHT.
WE CAN ALL WORRY TOGETHER.
>> DO YOU HAVE IDEAS HOW NIH MAY
MOVE FORWARD TO COMBAT THESE
TRENDS.
>> WE HAVE MANY IDEAS.
I THINK IT WOULD WARRANT A
SEPARATE SESSION OF THE COUNCIL
TO FLUSH THESE OUT.
MANY GROUPS ARE NOW LOOKING AT
THE ISSUE OF LACK OF TRUST IN
SCIENCE.
THAT'S SORT OF A MORE GLOBAL
ISSUE, IF YOU WILL.
THE CONCENTRATION OF RESOURCES
IN MY OPINION FAR TOO FEW
SCHOOLS OR INSTITUTIONS IN
GENERAL IS SOMETHING NIH HAS TO
ADDRESS.
WE HAVE TO DO IT IN CONCERT WITH
THE BIOMEDICAL RESEARCH
COMMUNITY.
>> IT SEEMS IT HAS TO BE DONE
SOON BECAUSE ANY POLICIES YOU
PUT IN PLACE ARE GOING TO TAKE
YEARS TO MAKE AN AFFECT.
>> NO QUESTION.
IN TERMS OF DISTRIBUTION OF
FUNDING ONCE A RESEARCH TEAM,
ALWAYS A RESEARCH TEAM.
I FULLY UNDERSTAND DIFFERENT
INSTITUTIONS HAVE DIFFERENT
BUSINESS MODELS AND I GET THAT
COMPLETELY.
BY NOT PROVIDING A MORE UNIFORM
FUNDING.
I'M TALKING ABOUT FUNDING
OUTSTANDING WORK I'M TALKING
ABOUT FUNDING WORK AND THERE'S
MANY INSTANCES.
THERE'S A TENDENCY TO
CONCENTRATION MORE AND MORE
RESOURCES AND THERE'S RELATIVELY
FEW INSTITUTIONS.
DANA.
>> YOUR STATISTICS SHOW
RESOURCES AND GRANTS ARE
CONCENTRATED IN CERTAIN
INSTITUTIONS.
ALSO DO YOU HAVE INFORMATION AND
STATISTICS ABOUT THE SAME PEOPLE
BE FUNDED FROM THOSE
INSTITUTIONS REPEATEDLY AND
TENDENCIES BETWEEN WHO GETS
FUNDED AND WHAT ARE THE ISSUES.
>> JUST BRIEFLY AND I'LL LET YOU
GO BECAUSE YOU DESERVE A BIO
BREAK.
MANY CASES IT'S THE SAME BEING
FUNDED MULTIPLE AWARDS.
YOU ALSO SEE THE FIRST
GENERATION COMING FROM THAT
INDIVIDUAL'S RESEARCH PROGRAM
BUT THE SENIOR MOST PERSON
REMAINS ATTACHED TO THE FUNDING
GIVEN TO THE MOST JUNIOR PERSON
AND THERE'S LEGITIMATE REASONS
FOR THAT BUT ALSO MAKES ONE
WONDER IF THIS IS SOMEBODY BUILD
LARGER AND LARGER RESEARCH
PROGRAM THROUGH SURROGATES.
MIKE, LET ME LET YOU HAVE THE
LAST WORD ON THIS.
>> GREAT QUESTION.
WE PUBLISHED A PAPER WE'LL PUT
IN THE CHAT.
>> IF THE COUNCIL THINKS THIS IS
SOMETHING WE SHOULD LOOK AT AND
BOTH THINGS IN MORE DETAIL LET
US KNOW AND WE CAN QUEUE THAT UP
FOR THE DECEMBER MEETING.
>> THAT WILL BE HELPFUL AND I
COME FROM A BIG INSTITUTION.
I FEEL MANY PEOPLE WHO DO NOT
HAVE A HISTORY OF GETTING GRANTS
FROM NIH DON'T EVEN KNOW HOW TO
GET INTO THE SYSTEM.
JUST LOOKING AT WHAT ARE THE
FACTORS THAT LOOK AT STATISTICS
OF THE INSTITUTIONS AND TRYING
TO REMEDY THOSE FACTORS.
>> I THINK IT'S VERY COMPLEX.
NO SINGLE SENTENCE COULD CAPTURE
THE COMPLEXITY.
I THINK OFTEN THERE'S AN OVER
EMPHASIS ON QUOTE THE RESEARCH
ENVIRONMENT AS IF THE ONLY PLACE
A CENTRIFUGE WOULD WORK IS AT
SOME FAMOUS ORGANIZATION.
MIKE, ANY FINAL COMMENT?
>> NO.
>> SO WITH THAT AS A TEASER, WE
CAN CONTINUE GOING FORWARD.
SHORT BREAK.
AT 11:45 WE'LL RECONVENE AND
HEAR A PRESENTATION BY DR. TARA
SCHWETZ ON ARPA-H WHICH I'M SURE
YOU WILL ALL FIND EXTREMELY
INTERESTING.
THANKS BACK AT 11:45.
>>I'LL TURN IT TO TARA.
>>THIS IS TO CATALYZE EFFORTS
AND ADAM RUSSELL WE'LL MENTION
IN A MOMENT IS ON THE CALL HERE.
I JUST WANT TO PROVIDE A LITTLE
BIT OF A BACKGROUND ON THE
MODEL.
ARPA-H WILL BE LEVERAGING AN
APPROACH AND HAS BEEN APPLIED IN
OTHER AREAS OF R&D LIKE THE
ENERGY COMMUNITY AND
INTELLIGENCE COMMUNITY.
IS THE MODEL PROMOTES
ACCOUNTABILITY THROUGH METRICS
AND STAGE GATING WITHIN A LEAN
AND NIMBLE ORGANIZATION THAT HAS
A FAIR AMOUNT OF AUTONOMY.
IT FOCUSES ON MISSION DRIVEN
RATHER THAN REQUIREMENT OR TASK
DRIVEN RESEARCH THAT IS BOLD AND
RISKY AND COULD OFFER A HIGH
RETURN.
IT ADHERES TO URGENT PRINCIPLES
THAT ARE APPLIED NOT JUST TO THE
PROGRAM'S DURATION BUT THE
STAFF'S TENURE.
AND EVERY DECISION AT ARPA-H
WILL BE INFORMED BY A MODIFIED
VERSION OF WHAT FOLKS AT DARPA
HAVE A NAME FOR.
AND FIRST BEFORE I GET TO THAT
IN MORE DETAIL I WANT TO OUTLINE
THE DRAFT MISSION FOR ARPA-H.
WHY ARE WE DOING THIS?
A LITTLE BIT ON THE HOW AND WHAT
AND WE'LL TALK MORE ABOUT
INVESTMENTS LATER ON IN THE
PRESENTATION.
THE IDEA IS TO EMPOWER EVERY
AMERICAN TO REALIZE THEIR HEALTH
POTENTIAL THROUGH PIVOTAL
INVESTMENTS IN HIGH-IMPACT
SOLUTIONS FOR WELL-DEFINED
PROBLEMS.
THAT PIECE IS CRITICAL BECAUSE
WE NEED TO PUT PARAMETERS ON
THOSE PROBLEMS.
THEN DEMONSTRATE WHAT HEALTH
FUTURES ARE POSSIBLE FOR ALL.
DARPA MAKES SEFT -- SET OF A USE
OF QUESTIONS AND THEY REFERRED
TO THEM THE HQs AND THE
QUESTIONS HELP AGENCY POTENTIAL
S AND THE HEILMEIER QUESTIONS
HELP MAKE DECISIONS AND WHAT'S
NEW IN THE APPROACH AND IN OTHER
WORDS, IF YOU'RE SUCCESSFUL WHAT
WILL BE THE IMPACT?
THAT IS CRITICAL AND THAT'S
CRITICAL TO ARPA-H AND ARPA-H IS
PROPOSING A REVISED VERSION OF
THESE THAT INCLUDES A
MODIFICATION TO EQUITY AND IT'S
IMPORTANT AND CRITICAL FOR IT TO
BE LINKED TO DRAW ON THE VAST
MOTH AND EXPERTISE AND
INFRASTRUCTURE THAT EXISTS AT
NIH.
HOWEVER, I THINK THERE'S ROBUST
AGREEMENT IT IS AND WILL REMAIN
DISTINCT WITH ITS OWN UNIQUE
CULTURE, ORGANIZATION AND
AUTONOMY.
ECHOING MANY ELEMENTS OF THE
MODEL ARPA-H WILL SEEK TO BRING
ON THE MOST INNOVATIVE PEOPLE
WITH THE MOST NOVEL IDEAS.
THAT WILL FORM ROBUSTLY DIVERSE
AND COLLABORATIVE TEAMS.
THE PROGRAM MANAGERS TO BE PART
OF THE TEAM ARE LIKELY TO BE
UNCOMMON.
THEY NEED TO BE TECHNICAL
EXPERTS AND PROGRAMMATIC
VISIONARIES.
EQUITY IS GOING TO BE CONSIDERED
AN ESSENTIAL ELEMENT AND KEY IN
INTERNAL PRACTICES.
THE PEOPLE THAT ARPA-H HIRES
INCLUDING PROGRAM MANAGERS, THE
PROGRAMS IT SUPPORTS AND THE
PERFORMERS IT MAKES AWARDS.
ANOTHER PRINCIPLE IN DRIVING
ARPA-H IS IT WILL BE NIMBLE AND
LEAN IN ITS ORGANIZATIONAL
STRUCTURE AND OPERATIONALIZING
IT'S PORTFOLIO AND BUSINESS
PRACTICES AND THE DIRECTION FOR
THE TENURE OF PEOPLE THERE AND
WILL DO SO IN A WAY THAT'S
DYNAMIC AND EVOLVING AND
ADAPTIVE.
AND BE OPEN AND TRANSPARENT
ABOUT THE PROCESSES IT USES AND
ENGAGE STAKEHOLDERS ACROSS A
RANGE OF SECTORS AND DISCIPLINE
EARLY AND OFTEN TO HELP INFORM
AND PROMOTE INDEPENDENCE AND
ACCOUNTABILITY REENFORCED BY THE
AMBITIOUS MILESTONES AND METRICS
AND SEEK TO HAVE PROGRAMS THAT
COULD OFFER OUTSIZED IMPACT OR
RETURN.
AND NORMALIZE THE FACT THAT NOT
ALL OF THESE ARE GOING TO BE
SUCCESSFUL IS A CRITICAL POINT.
TO TALK BRIEFLY ABOUT THE
LEGISLATIVE STATUS AND WHERE
THEY STAND WITH ARPA-H.
TALK ABOUT THE LEAD UP AND SINCE
RECEIVING FUND FROM THE OMNIBUS.
LAST SUMMER OSTP AND NIH
OUTLINED A VISION FOR ARPA-H AND
SOUGHT FEEDBACK FROM A LOT OF
PEOPLE ON THIS CALL EVEN AND
WE'RE FAST FORWARDING TO EARLIER
THIS YEAR WHERE ARPA-H WAS
INCLUDED IN THE OMNIBUS.
I'LL HIGHLIGHT SOME PROVISIONS.
IT WAS FUNDED AT A BILLION
DOLLARS AVAILABLE FOR THREE
YEARS.
IT PROVIDED A HIGHER MECHANISM
WITH HIGHER COMPENSATION RATES.
IT GAVE THE SECRETARY TO
CONTROVERSY IT WITHIN NIH AND
THAT DECISION WAS MADE AND
ARPA-H WAS TRANSFERRED AND
ESTABLISHED WITHIN NIH.
THERE'S A LOT OF WORK THAT GOES
TO STANDING UP A NEW
ORGANIZATION.
I'LL BRIEFLY WALK YOU THROUGH
THE ORGANIZATIONAL STATUS OF
ARPA-H.
AS MENTIONED SINCE THE OMNIBUS
IT WAS TRANSFERRED TO AND
ESTABLISHED TO NIH.
THE PRESIDENT REQUESTED $5
BILLION IN THE FY23 BUDGET TO
HELP GROW ARPA-H.
I'LL TALK ABOUT THE OTHER
PROGRESS WITH LEADERSHIP IN
MOMENTS.
ARPA-H AND NIH WILL NEED TO BE
SYNERGISTIC IN PRELS PRINCIPLES
AND FOCUS AND HAVE THE
INFRASTRUCTURE AVAILABLE HERE.
IT WILL RELY ON NIH FOR SOME OF
THE FUNCTIONS LISTED ON THE
SLIDE AND THIS GETS INTO THE
WEEDS QUICKLY BUT WE THINK ABOUT
THINGS LIKE THE BUDGET SYSTEMS
CYBER AND PHYSICAL SECURITY AND
THE I.T. THAT ALLOWS WORK TO BE
ACCOMPLISHED AND MANY MORE
FUNCTIONS.
THE FOCUS WILL BE ON BUILDING
OUT PATHWAYS AND LAY THE GROUND
WORK FOR THE VARIOUS PROCESSES,
POLICIES AND FUNCTIONS THAT
ARPA-H MIGHT WISH TO EITHER
ADOPT, ADAPT OR BUILD FROM
SCRATCH.
WE HAVE A GROWING TEAM THAT'S
BEEN PLANNING FOR THE STAND UP
OF ARPA-H FOR THE PAST FEW
MONTHS AND FOCUSSING ON DOING
NEEDS ASSESSMENTS AND
REQUIREMENTS GATHERING AND IN
SEVERAL KEY FOCUS AREAS.
THESE RANGE FROM ACQUISITION TO
CONTRACTING TO BUDGET STRATEGIC
PLANNING AND STRATEGY RESOURCE
DEVELOPMENT AND LOTS OF OTHER
AREAS AS WELL AND WITH THE
PASSAGE OF THE FY22 OMNIBUS
WHERE WE RECEIVED RESOURCES,
WE'RE STARTING TO TURN ATTENTION
TO IMPLEMENTATION.
I'M NOT GOING TO DO INTO A LOT
OF DETAIL BUT TO HIGHLIGHT THE
FOCUS AND WORK GOING IN THE
AREAS INCLUDING ACTIVITIES TO
DEVELOP PROGRAM MANAGER
PROCESSES.
HOW TO LAUNCH PROGRAMS AND
ANALYZE DATA FROM PROCESSES AND
PROGRAMS IS AN IMPORTANT FEATURE
TO ARPA-H WILL BE A ROBUST
SYSTEM TO CAPTURE AND ANALYZE
DATA SO IT BE EVIDENCE TO
SUPPORT DECISION MAKING IN REAL
TIME.
AND ROBUST VIRTUALIZATION
PROGRAM WE'LL BE ABLE TO BUILD
OUT AND HIRE EXCEPTIONAL PEOPLE
AND GETTING THEM UP AND RUNNING
QUICKLY AND BUILDING OUT A
DYNAMIC AND INNOVATIVE
CONTRACTING JOB AND DOING ALL
THESE THINGS IN A REALLY
ORGANIZED MANNER THAT CONSIDERS
CHANGE MANAGEMENT AND THE
CULTURE WE'D LIKE TO BUILD FOR
ARPA-H AN IMPORTANT FEATURE WILL
BE IDENTIFYING LEADERSHIP FOR
ARPA-H WITH ARPA EXPERIENCE.
HOPING TO SEE PROGRESS IN MOVING
FORWARD WITH THE APPOINTMENT OF
AN INAUGURAL DIRECTOR THROUGH A
PRESIDENTIAL APPOINTMENT.
EMPOWER A COHORT OF DIVERSE
STAFF AND SET OUT THE
ORGANIZATION AND THEY'LL OUTLINE
THE SCIENTIFIC FOCUS OF ARPA-H.
THERE'S THE TYPES OF PERSONS WE
MIGHT WANT TO RECRUIT OR
HOPEFULLY HAVE IN THIS POSITION
AND GOING TO NEED TO BE AN
EXTRAORDINARY LEADER WITH A
PROVEN TRACK RECORD AND VISION
FOR DRIVING TRANSFORMATIVE
CHANGE IN HEALTH OR BIO
MEDICINE.
IT WOULD BE GREAT IF THEY SPENT
TIME IN ACADEMIA AND UNDERSTAND
THE ENVIRONMENT THEY'LL BE
COMING INTO MORE THOROUGHLY AND
TO BE A DIPLOMATIC AND ADVOCATE.
IT WILL BE A KEY ELEMENT TO
ARPA-H'S SUCCESS.
A COUPLE WEEKS AGO WE ANNOUNCED
ADAM RUSSELL AS THE ACTING
DEPUTY DIRECTOR OF ARPA-H.
HE WAS THE CHIEF SCIENTIST AT
THE UNIVERSITY OF MARYLAND AND A
FORMER DARPA PROGRAM MANAGER AND
FAMILIAR WITH THE MODEL ARPA-H
IS BEING BASED ON.
HE UNDERSTANDS THE CULTURE AND
PRINCIPLES WE WANT TO BUILD.
HE'S A SOCIAL ANTHROPOLOGIST BY
TRAINING.
ONE OF THE OTHER MILESTONES IS
THE RECEIPT OF A PROFESSIONAL
HEAD OF CONTRACTING ACTIVITY OR
HCA WHICH WILL GIVE IT A LOT OF
FLEXIBILITY AND INDEPENDENCE TO
MAKE THE AWARD.
IT'S VERY INSIDE BASEBALL, IF
YOU WILL, AND VERY MUCH A
PROCESS THAT NEEDS TO OCCUR BUT
IT'S GOING TO BE A CRITICAL
FUNCTION FOR ARPA-H.
WORKING THROUGH OTHER PLANS FOR
OPERATIONS AND THE FUNCTIONAL
AREAS I MENTIONED PREVIOUSLY.
WORKING TOWARDS PUBLISHING THE
FIRST BROAD AGENCY ANNOUNCEMENT.
WE HAVE SEEN HOW SUCCESSFUL IT'S
BEEN AT DARPA AND OTHER ARPAs
ACROSS THE FEDERAL AND SO MANY
AREAS ARE RIPE FOR
TRANSFORMATION AND SO MANY
POTENTIAL OPPORTUNITIES TO SHAPE
THE FUTURE OF HEALTH AND
MEDICINE AND SIGNIFICANTLY
IMPROVE THE QUALITY OF LIFE FOR
ALL AMERICANS.
I'M EXCITED TO SEE HOW TOMORROW
GROW.
SHELLY, DO YOU WANT TO MAKE A
COMMENT?
>> IT'S AN EXCITING INITIATIVE
AND LOOKING TO LARRY'S PREVIOUS
COMMENTS TO TRY TO BUILD IN
TREMENDOUS DIVERSITY IN THE WAY
THIS IS IMPLEMENTED SINCE IT'S
GOING BE PROBABLY THE BIGGEST
INITIATIVE THAT'S COME FOR A
WHILE AND WILL BE COMING.
I WONDERED WHAT YOUR THOUGHTS
WERE ABOUT THAT AND HOW TO
IMPLEMENT.
>> IN SOME SENSE WE GET TO START
A LITTLE BIT FROM SCRATCH AND SO
WE'RE TAKING THINGS IN AN IDEAL
WAY AND BRACE IT THROUGH DYNAMIC
OPTIMIZATION ELEMENTS WE WANT TO
EMBRACE FOR ALL THE PROCESSES
FOR ARPA-H.
WHAT THAT MEANS PRACTICALLY IN
THIS AREA IN PARTICULAR IS THAT
WE'RE GOING TO BE CONSTANTLY
EVOLVING AND LEARNING AND TRYING
THINGS AND SEEING IF WE'RE BEING
SUCCESSFUL IN THE DIFFERENT
APPROACHES WE USE.
HOPEFULLY A LEARNING OPPORTUNITY
NOT JUST FOR ARPA-H BUT MORE
BROADLY.
I SEE A QUESTION FROM HOWARD
CHANG.
>> I WAS GOING TO ASK WHETHER
THE PROGRAM OFFICERS WHICH IS
KEY TO ARPA-H, THE HIRING WILL
COME FROM NIH OR OUTSIDE
ORGANIZATION.
IS THERE A CONCERN OF A BRAIN
DRAIN OR CHANGING THE CHARACTER
OF THE TWO ORGANIZATIONS AS A
RESULT?
>> THAT'S A GREAT QUESTION.
THESE ARE SHORTER TERM POSITIONS
COMING ON BOARD THE TO SIX YEARS
AT A TIME.
HOPEFULLY BE THE ROBUST CHURNING
OF PROGRAM MANAGERS THAT COME
IN.
THERE ARE OPPORTUNITIES AND ON
THE OPERATIONAL SIDE OF THINGS
WHERE IT MAY BE A VALUE TO HAVE
INSTITUTIONAL KNOWLEDGE FROM
SOME NIH STAFF BUT AGAIN WE WANT
TO THINK BROADLY AND ROBUSTLY
AND PULL IN PEOPLE WHO ARE
FAMILIAR WITH THIS ARPA-H MODEL.
AND PEOPLE WHO HAVE EXPERIENCE
THAT IS EVEN OUTSIDE OF THE
TRADITIONAL PATHWAYS WE THINK OF
WITH THE BIOMEDICAL AND HEALTH
COMMUNITY.
PEOPLE TO BRING IN NEW
PERSPECTIVES TO THE FIELD.
>> THANK YOU.
>> THEY HIRED AN ANTHROPOLOGIST
AS AN NIH DIRECTOR IS CRAZY.
>> THAT'S ADAM RUSSELL FOR FOLKS
WHO ARE UNAWARE.
IT JUST SAYS ADAM'S iPHONE.
>> ADAM IS CRAZY OR THE HIRING
OF ADAM IS CRAZY.
>> TBD.
IT'S AN EMPIRICAL QUESTION.
>> TARA, I THINK WE LOST
CHRISTINA FOR SOME DUTY SHE
NEEDED TO PERFORM BUT REMINDS US
SHE HELPED SET UP ARPA-H AT THE
DOE IN 2009 AND HAS SOME UNIQUE
INSIGHTS TO ALL OF THIS.
IF YOU INTERACTED WITH THE
ARPA-H DEPUTY IN THE CHAT BOX.
>> WHILE AT OSTP I NOT ONLY
TOUCHED BASE WITH HER BUT MANY
PEOPLE SHE SUGGESTED I REACH OUT
TO SHE WAS INCREDIBLY HELPFUL TO
ME IN PROVIDING LESSONS LEARNED
AND DEPUTY DIRECTOR FOR
OPERATIONS AT ARPA-E.
HE HAS BEEN AN AMAZING RESOURCE.
I DON'T KNOW IF HE WAS EMPLOYEE
NUMBER ONE BUT CLOSE TO IT AND
HAS HAD A LOT OF VERY HELPFUL
ADVICE.
I APPRECIATE ALL SHE'S DONE
PREVIOUSLY AND CONTINUES TO DO.
>> OKAY.
THANKS DAVID FOR THE PROMPT.
WE'LL TAKE THE SLIDES DOWN
DURING THE DISCUSSION PERIOD.
>> THERE'S INITIATIVES FROM
OTHER INSTITUTES.
I'M TRYING TO THINK, WILL THERE
BE A MECHANISM BY WHICH THERE'S
COORDINATION BETWEEN THE BROAD
AGENCY ANNOUNCEMENTS FROM ARPA-H
VERSUS WHAT'S COMING UP ALL THE
TIME FROM SOME OTHER INSTITUTES
AS WELL?
SOMETIMES THE SAME LANGUAGE IS
USED.
>> I THINK SOME OF THE
DIFFERENCES BETWEEN SOME OF THE
FUNCTIONS OF NIH AND ARPA-H IS A
LITTLE BIT ON THE APPROACH.
IT WILL BE DIFFERENT BUT ALSO ON
SOME OF THE TYPES OF THINGS
WE'LL BE WORKING ON.
TO YOUR POINT ABOUT HOW ARPA-H
PLANS TO COORDINATE ACROSS NIH
WITH THE NIH INSTITUTES AND
CENTERS, IN TERMS OF PROGRAM
DEVELOPMENT, IT'S GOING TO BE A
VERY ENGAGED ITERATIVE PROCESS
THAT WILL REQUIRE AND
NECESSITATE A LOT OF INTERACTION
WITH PEOPLE ACROSS THE COMMUNITY
AND OBVIOUSLY INCLUDING NIH.
I GREAT STARTING POINT ALL THE
TIME IS GOING TO BE JUST WHAT IS
NIH DOING AND BE PUSHING FORWARD
TO CATALYZE WHAT IS TRYING TO BE
LARGE IN THINKING.
WE WANT TO MAKE SURE WE'RE
ASKING VERY HIGH-LEVEL BUT
DISTINCT AND WELL-DEFINED
QUESTIONS TO CHALLENGES THAT
HAVE HERETOFORE BEEN DIFFICULT
TO ACCOMPLISH.
>> HOW'S IT BEING TODAY AND
IMPOSSIBLE AND FIND OUT WHO IS
DOING STUFF IN THE AREA ALREADY
AND WHERE ARE THEY STRUGGLING.
IT'S NOT LIKE WE'RE GOING TO DO
BETTER THAN WE ARE.
IT'S A FUNDAMENTAL CHALLENGE IF
WE CAN GET OVER THAT, IT WOULD
ACCELERATE EVERYBODY'S
CAPABILITIES AND EMPOWER THEM
AND SO WHAT'S NEW?
WHAT IS ARPA-H GOING TO ADD TO
THE ONGOING CONVERSATION,
EFFORT, RESEARCH, PROJECT,
ETCETERA.
WE CAN'T ANSWER THAT, WE DON'T
MOVE OUT.
THAT'S HOW IT'S BAKED IN TO MAKE
SURE WE'RE NOT MAKING THINGS UP
ON OUR OWN.
I HOPE THAT HELPS.
>> THEY'LL HAVE TO JUSTIFY WHAT
THEY'RE DOING AND WHY.
AND WHY IT ISN'T BEING DONE
ALREADY AND IF IT IS, IT'S
PROBABLY NOT SOMETHING ARPA-H
WANTS TO VENTURE INTO.
>> THAT LEADS VERY WELL INTO
DAVID'S POINT.
>> LIKE THE OVER ALL APPROACH
AND LIKE TO SEE THE PROGRESS AND
THINKING WHAT WILL THIS
CONCRETELY TURN INTO.
IT FEELS LIKE WE'RE AT THE
ADJECTIVE LEVEL AND I WANT TO
GET TO THE NOUN LEVEL.
I'M WONDERING WHAT YOUR THOUGHTS
ARE ON GETTING PROTOTYPICAL OR
EMBLEMATIC OR ASPIRATIONAL.
HERE'S AN EXAMPLE OF THE KIND OF
PROGRAM.
THAT COULD BE IN THE FORM OF,
HERE ARE TEN SETS OF ANSWERS TO
THE QUESTIONS THAT MAY OR MAY
NOT BE THE ACTUAL CORRECT
SCIENCE BUT ARE THE CORRECT
LEVEL TO ANTICIPATING THE
QUESTION OF DYNAMIC AND
TRANSFORMATIONAL.
WHAT'S THAT MEAN?
THIS IS NOT AN NIH THING, THIS
IS AN ARPA-H THING.
WHAT ARE YOUR THOUGHTS HOW AND
WHEN WE SHOULD MOVE?
>> THAT'S A GREAT QUESTION.
>> IT NEEDS TO BE INFORMED BY
THE INAUGURAL DIRECTOR AND
DEVELOP THEIR VISION FOR THE
AGENCY.
I KNOW ADAM IS STARTING TO THINK
ABOUT THIS AND HAS THOUGHT ABOUT
THE TYPES OF EXAMPLES YOU'RE
REQUESTING.
SINCE YOU'RE HERE YOU MIGHT AS
WELL ELABORATE.
>> TO BE FAIR I DROPPED FOR 30
SECONDS AS A MOVING TARGET SO
WHAT ARE WE GOING TO DO OR
TOPICS?
>> AN CONCRETE EXAMPLES TO HELP
OTHERS KNOW WHAT PROPOSALS WE
SHOULD BE MAKING THE RIGHT SHAPE
AND SIZE.
WHENEVER I TELL YOU A NEW
DIRECTOR CAN COME IN AND SAY DID
YOU LISTEN TO THAT GUY WHICH IS
FINE.
THE WAY THE ARPA-H STRUCTURE
WORKS IS WE HAVE MISSION OFFICES
AND THEY'LL HAVE ROUGH AREAS OF
RESPONSIBILITIES.
A PROGRAM MANAGER CAN COME IN
WITH AN IDEA.
THERE'S EXCITEMENT WHAT TO DO
WITH ELECTRONIC HEALTH RECORDS
IF WE CAN FIX THE OPERABILITY
PROBLEM.
I DON'T THINK THAT'S THE
PROBLEM.
I SEE OTHER PROBLEMS THAT KEEP
US FROM DOING WHAT WE WANT TO
DO.
WHAT DRIVES ME NUTS IS THE
SYSTEMS DON'T TALK TO EACH
OTHER.
HERE'S MY CRAZY IDEA.
I THINK IF WE DO X WE CAN DO
THAT.
INCLUDING LIMITATIONS AND WHY
YOU THINK IT'S POSSIBLE AND THE
ARPA-H DIRECTOR WILL SAY LET'S
GO FOR IT.
HERE'S A BUNCH OF MONEY AND
HERE'S THE MILESTONES AND WE
WANT TO KNOW WHETHER YOUR CRAZY
IDEA WILL PAN OUT.
I HAD THE QUESTION THIS MORNING
DURING THE INTERVIEW OF TRYING
NOT TO OVER FIXATE ON SPECIFIC
DISEASES.
WE HEARD THAT FROM THE TALK
SESSIONS.
IT'S IMPORTANT.
THINK ABOUT SUITE.
IF SOMEONE COMES IN AND HAS AN
IDEA HOW TO RUN IN SUITE AND
GIVEN THE COMORBIDITIES SLEEP IS
INVOLVED IN AND GIVE BACK GOOD
BIOLOGICAL SLEEP IS SOMETHING WE
COULD PILE IN TO NOTING LOTS OF
WORK ON SLEEP.
THE HARD WORK FOR THE MANAGER IS
TO POINT TO THE WORK DONE ON
SLEEP AND FIND THE CRUX OF THE
HARD PART WE CAN'T FIX NOW OR
THE HARD PARTS AND ARPA-H CAN
HAVE A RUN AT THAT.
WE MAY FAIL.
IT MAY BE TOO CRAZY TO WORK, BUT
IF IT WORKS IT WOULD BE VALUABLE
TO ALL THE FOLKS DOING THE HARD
WORK THERE ALREADY.
SLEEP AND EARLY DIAGNOSIS OF
DISEASE AND SOCIAL LEVEL I'M
CONCERNED ABOUT THAT.
I SAW SOMETHING IN THE CHAT
ABOUT MISINFORMATION.
DOES ARPA-H BELONG IN THAT SPACE
AND DEAL WITH MISINFORMATION?
WE LIVE SURROUNDED BY
MISINFORMATION.
AND LEADING TO BAD DECISIONS
ABOUT HEALTH.
I SHOULD WE SHOULD ENTERTAIN
THAT IDEA AND IF SOMEONE NEEDS
AN APPROACH TO HELP ADDRESS SOME
OF THAT, GREAT.
SUPPLY CHAIN RESILIENCE IS A BIG
ISSUE.
OR DEALING WITH A MULTI-AGENT
SYSTEM THAT ALLOW YOU TO COME UP
WITH SOLUTIONS FOR THE MISAL
MISALIMISAL
MISALIGNED COMPETITORS AND WE GO
THROUGH THE PROCESS AND NEED A
PROGRAM MANAGER.
IF WE DON'T HAVE SOMEBODY THERE
TO DRIVE, WE WON'T DO IT.
>> TO DAVID'S POINT, I HAVEN'T
HEARD ABOUT HEALTH EQUITY.
THIS MAY BE A QUESTION AND
DAVID'S POINT ABOUT HAVE HEALTH
EQUITY BE A PRIORITY AND YOU'RE
THINKING AND FUTURE EMPLOYEES
COME ON BOARD.
>> TARA, DO YOU WANT TO TAKE
THIS?
>> GO AHEAD.
I AGREE.
THE IDEA WOULD BE TO THINK ABOUT
IT IN A MULTI-PRONGED WAY
BECAUSE WE NEED TO BRING IN
PROGRAM MANAGERS AND OTHER STAFF
AND HAVE DIVERSE PERSPECTIVES TO
HELP THINK THROUGH AND IDENTIFY
SOME OF THE CHALLENGES THAT WE
MAY WANT TO TACKLE IN TERMS OF
HEALTH EQUITY FOR A SPECIFIC
PROGRAM.
ALSO AS YOU SAW IN THE REVIVED
HEILMEIER QUESTIONS PROPOSED,
HAVE QUESTIONS FOR HEALTH EQUITY
AND IT WILL BE APPLICABLE FOR
EVERY PROGRAM THROUGH ARPA-H.
THERE HAS TO BE SOME
CONSIDERATION GIVEN TO THAT FROM
THE BEGINNING EVERY PROGRAM TO
HAVE PROGRAMS THAT HAVE A
SPECIFIC FOCUS ON HEALTH EQUITY
CHALLENGES BUT ALSO WANTING
EVERY PROGRAM TO CONSIDER IT AS
IT'S BEING DEVELOPED AND BUILT
OUT AND THEN OF COURSE -- ADAM
WERE YOU GOING TO GO.
>> NO, I'M JUST EXCITED.
IT'S THE BENEFIT OF BEING ABLE
TO START FROM SCRATCH IN A WAY.
TWO THINGS TO ADD.
FIRST IS WE'RE COMMITTED TO
METASCIENCE AND INTERESTED IN
TRACKING AND STUDYING OURSELVES.
WE DO THAT TO IMPROVE THINGS.
DOES ARPA-H LOOK AMERICA?
THAT'S IMPORTANT.
AND DON'T BE SURPRISED IF IT
ENDS UP LOOKING DIFFERENTLY TO
GET PEOPLE IN ARPA-H.
THE CRITICAL FEATURE OF THE
HEILMEIER QUESTION AND IF YOU
CAN'T CREDIBLY ANSWER THE
QUESTION, WE'RE NOT GOING TO
LAUNCH.
IT'S NOT WINDOW DRESSING IF YOU
CAN'T ENSURE THE RESULTS ARE
EQUITABLE, YOU'RE NOT GETTING
MONEY.
THAT'S HOW IMPORTANT THAT IS.
THAT'S WHY IT'S A BIG DEAL.
>> DID YOU WANT TO WEIGH IN?
>> WHAT KIND OF INSTITUTIONS
WILL APPLY FOR ARPA-H?
YOU THINK OF THOSE THAT APPLY
FOR ARPA AND DARPA YOU SEE THE
TRADITIONAL NIH APPLICANTS ALSO
PLAYING A ROLE HERE.
>> WE HAVE PERFORMERS COMING
FROM A VARIETY OF AREAS AND
SEGMENTS OF THE COMMUNITY.
FROM ACADEMIC RESEARCHERS TO
COMPANIES TO SMALL BUSINESSES.
AND EVERYTHING AND EVERYONE IN
BETWEEN.
IDEALLY WE'RE GOING TO BE
PROMOTING THESE LARGE-SCALE
CHALLENGES THAT WILL PROBABLY
NECESSITATE
INTERDISCIPLINARY-TRANS
DISCIPLINARY APPROACHES.
HOPING PEOPLE WILL COME TOGETHER
AND FORM TEAMS THAT ARE NOT THE
TYPICAL TEAMS WE'D PUT TOGETHER
NECESSARILY.
WE'LL TRY TO ENCOURAGE THAT
FORMATION.
>> I WAS IN THE DEFENSE SCIENCES
OFFICE.
DARPA HAS SIX DIFFERENT OFFICES.
DEPENDING ON THE LEVEL OF
MATURITY OF THE PROBLEM OR
SOLUTION YOU'RE FOCUSSED ON,
YOU'LL GET A RANGE OF PEOPLE.
AT DSO WERE FOLKS AT FUNDAMENTAL
RESEARCH AND TRYING TO DEVELOP
NEW MECHANISMS TO PRODUCE
RESEARCH.
WE HAD TONS OF UNIVERSITIES BUT
ALSO UNIVERSITIES WORKING WITH
SMALL COMPANIES WHO HAVE SINCE
GONE ON TO TRY TO COMMERCIALIZE
THE ALGORITHMS.
IF WE DO THIS RIGHT THE BEST
IDEAS WILL COME FROM DIVERSE
GROUPS.
>> IS THERE THINKING IT'S
SHORT-TERM, GIVE IT YOUR ALL AND
THEN SOMEONE ELSE COMES IN?
>> WE'RE THINKING LONGER TERM.
FOR ARPA-H THE IDEA WE'RE
THINKING ABOUT HERE IS DOING
THREE-YEAR TERMS RENEWABLE ONE
TIME.
THERE CAN BE TURNOVER IN THE
PEOPLE COMING ON BOARD IN THE
PROGRAM MANAGER ROLE.
THEY'LL LAUNCH A PROGRAM OR TWO
OR THREE IN THEIR TENURE AND
WILL LIKELY NOT SEE IT RUN THE
ENTIRE DURATION THEY ARE THERE.
SOMEONE ELSE WILL COME IN AND BE
ABLE TO TAKE OVER THEIR PROGRAM
AND I THINK THERE'S A LOT OF
VALUE IN THAT BECAUSE YOU'RE
BRINGING IN A NEW PERSPECTIVE
AND IT MIGHT BE SUCH THAT THE
PROGRAM HAS EVOLVED AND CHANGED
IN THE TYPE OF EXPERTISE AND
PROGRAM MANAGER THAT WOULD BE
NEEDED.
IT WOULD BE DIFFERENT IN YOUR
THREE -- IN YEAR THREE THAN
ONE.
>> EXECUTION WILL BE MORE STAFF
DRIVEN OR NEW STAFF COME IN FOR
THAT.
>> DO YOU SEE DOLLARS FOR
TRANSLATIONAL RESEARCH MOVING
TOWARDS ARPA-H AWAY FROM THE
REST OF NIH LET'S SAY?
.
>> THEY WERE HANDING ME STUFF TO
RUN WITH BECAUSE IT WAS MORE
LIKE HOLDING DOLLARS.
>> THE IDEA IS TO SHOP
THEMSELVES TO THE APPROPRIATE
VENUE FROM A LARGER CONSTITUENCY
OF APPLICANTS.
FINAL QUESTION AND I'LL TURN IT
OVER TO OTHERS.
IF YOU CAN USE PHRASES LIKE
DYNAMIC AND TRANSFORMATIONAL
WITH ARPA-H FUNDS WHY CAN'T WE
USE THEM AT NIH?
>> YOU STARTED TO SAY WHAT I WAS
GOING SAY.
>> THEY'RE NOT MUTUALLY
EXCLUSIVE AND THERE'S BEEN GOOD
EXAMPLES IN RESPONSE TO THE
PANDEMIC IN PARTICULAR WHERE I
THINK YOU CAN ILLUSTRATE HOW NIH
HAS BEEN AND IT'S BEEN DYNAMIC
AND TRANSFORMATIONAL AND
THINKING ABOUT THE ACTIVE
PARTNERSHIP WE HAVE RADX AND THE
LIST GOES ON AND ON.
AND A DIFFERENCE IN APPROACH IN
HOW WE'RE SUPPORTING RESEARCH
AND THINKING ABOUT THAT
APPROACH.
THAT'S ONE OF THE THINGS.
AGAIN, WE HOPE THIS IS A VERY
SYNERGISTIC AND COLLABORATIVE
EFFORT THAT HAPPENS BETWEEN
ARPA-H AND NIH.
LARRY, DID YOU WANT TO --
>> AGAIN, I DON'T THINK I NEED
TO REMIND THIS GROUP BUT WILL
FOR COMPLETENESS, THE ADVANCES
THAT WERE MADE DURING THE
PANDEMIC WERE BUILT UPON MANY
YEARS OF BASIC RESEARCH.
NIH HAS CONTINUED TO FUND THE
FUNDAMENTAL WORK.
WITHOUT IT, YOU'RE NOT GOING TO
SEE THE BREAKTHROUGHS.
IN A SENSE WE GOT FORTUNATE
BECAUSE THE PANDEMIC WAS A VIRUS
WE ALREADY KNEW QUITE A BIT
ABOUT.
HAD IT BEEN A VIRUS WE DID KNOW
A BIT ABOUT THE RESULTS WOULD
NOT HAVE BEEN AS POSITIVE.
>> I THINK TO THE POINT OF
USING TERMS LIKE DYNAMIC AND
TRANSFORMATIONAL.
EVERY PROGRAM WILL GO THROUGH
WHAT WE CALL DARPA TECH COUNCIL
AND HERE CALLED SCIENTIFIC TECH
COUNCIL IF YOU WANT TO GET
MURDERED TALK ABOUT YOUR PROGRAM
IS DYNAMIC AND DON'T HAVE
METRICS AND SEE HOW FAST YOU'RE
SENT BACK TO THE FLOOR.
I THINK WE'LL BAN WORDS LIKE
DYNAMIC AND INNOVATION.
IT MEANS SO YOU'RE CHANGING
PERFORMERS EVERY SIX MONTHS.
I CAN UNDERSTAND THAT.
YOU DON'T NEED THE WORD DYNAMIC
FOR THAT.
TO YOUR POINT, WE CAN TALK ABOUT
IT ALL WE WANT BUT IT COMES DOWN
TO METRICS AND PEOPLE WHO TRY TO
GET AWAY WITH IT'S A DYNAMIC
PROGRAM AND DON'T HAVE METRICS
IT WON'T BE A GOOD PLACE FOR
THEM.
THERE GOING TO BE OPPORTUNITIES
FOR BACKGROUND AROUND THE IDEA
OF SUPPORT AND RESEARCH.
THERE MAY BE NEW APPROACHES TO
MAKING AWARDS THAT ARPA-H MIGHT
PIONEER AND NIH MAY BE ABLE TO
ADOPT WITH AUTHORITIES THAT
EXIST.
WE ARE HOPING TO REALLY HAVE IT
BE A LEARNING PROCESS OVER ALL.
I CAN'T TELL THE ORDER OF THE
QUESTIONS.
>> I THINK SHELLY HAD THE NEXT
QUESTION.
I WANTED TO POINT OUT THE
STABILITY OF RNA FOR THE
VACCINES WAS ABSOLUTELY CRUCIAL
TO WHERE WE ARE NOW RETURNING TO
NORMAL FROM RESEARCH DONE A LONG
TIME AGO.
WE WERE TALKING ABOUT TOPICS
AND IT'S AMAZING THE
TECHNOLOGICAL BREAKTHROUGH AND I
DIDN'T DEMAND AS THE BOTTLENECK
AND HE THINKS ARPA-H CAN GET
INTO THE BRINGING THE SOCIO
ECONOMIC STUFF TO THE MODELS TO
ANTICIPATE THIS SO GOOD POINT.
>> ARE THEY TAKING ON RESEARCH
RELATED TO GUN VIOLENCE.
>> IT HAS TO ANSWER THE
HEILMEIER QUESTION AND FIT THE
VISION FOR THE ORGANIZATION.
>> IS THERE A TRANSFORMATIVE WAY
TO GO AFTER THE BEHAVIORAL
ASPECTS THAT LEAD PEOPLE TO
EITHER COMMIT GUN VIOLENCE OR
THE FEAR THAT CAUSES HIGH-LEVELS
OF GUN OWNERSHIP, THAT KIND OF
THING.
I REALIZE NIH AND OTHER AGENCIES
CAN'T DO THINGS THAT ARE ABOUT
THE POLICY BUT THE UNDERLYING
EPIDEMIOLOGY AND BIOLOGY OF
HUMAN BEHAVIOR SURELY IS.
TAGGING ON TO SHELLY'S POINT I
THINK IT'S INTERESTING IN THE
HISTORY OF THE RNA VACCINES
DARPA HAD A ROLE TO PLAY IN THE
BACKGROUND WORK.
IT'S A CLASSIC CASE WHERE BOTH
HAD TO PUSH FROM DIFFERENT
DIRECTIONS.
>> CORRECT.
>> IT'S AN ECO SYSTEM.
>> DAVID, DID YOU HAVE A
FOLLOW-UP?
>> IT WAS COVERED, THANKS.
>> THANK YOU.
DINA.
>> I'M WONDERING IF YOU LOOK AT
NIH TRADITIONALLY THE
INVESTMENTS AT NIH ARE VERY MUCH
CORE IN BIOLOGY, BIO MEDICINE
AND MEDICINE.
I'M WONDERING WHAT IS THE VISION
IF ARPA-H WITH RESPECT TO
MACHINE LEARNING AND COMPUTER
SCIENTIST AND MACHINE LEARNING
EXPERTS PART OF THIS OR KNOW THE
FOCUS IS IN A DIFFERENT
DIRECTION?
>> THEY'RE ABSOLUTELY PART OF
IT.
IT HAS TO COME WITH THE WELL
DEFINED QUESTION AND HELPING
DESIGN PROGRAMS THAT MAY BE MOST
RELEVANT BUT YOU CAN IMAGINE A
BROAD USE OF COMPUTER SCIENCE
AND DATA SCIENCE AS PART OF MANY
DIFFERENT TYPES OF QUESTIONS
THAT ARPA-H MAY WANT TO TACKLE.
>> DO YOU ENVISION THE PROGRAM
MANAGEMENT WOULD BE FOCUSSED IN
THOSE AREAS?
>> POTENTIALLY.
WE NEED THE INAUGURAL DIRECTOR
TO OUTLINE THE VISION.
I APOLOGIZE FOR BEING A LITTLE
BIT OF A BROKEN RECORD THERE BUT
THEY NEED TO DEFINE WHAT THEIR
VISION IS FOR ARPA-H.
I WOULD IMAGINE THAT THERE WILL
BE SOME ELEMENT OR PROGRAM
THAT'S RELATED TO THIS.
>> LET ME PRE-REGISTER THE
HYPOTHESIS NOW I'D BE SURPRISED
GIVEN THE EXPERTS AND VISIONARY
FOCUS.
I'D BE SURPRISED IF WE'RE NOT
THERE.
>> I WANT TO ADD ONE THING WHICH
IS THAT I HAVE NO DOUBT THERE'S
A HUGE AMOUNT OF INTEREST IN THE
POTENTIAL AND PROCEDURE AND WHAT
KIND FUTURE THERE IS ON THESE
KINDS OF ISSUES.
>> OTHER COMMENTS OR QUESTIONS
ABOUT ARPA-H?
>> I'LL ONE I KNOW YOU WON'T BE
ABLE TO ANSWER BUT JUST IN CASE.
TIMING FOR A DIRECTOR TO BE
NOMINATE AND GET YOU OFF YOUR
BROKEN RECORD.
>> UNCLEAR.
AGAIN, IT'S A PRESS --
PRESIDENTIAL APPOINTEE.
IT'S NOT AS ROBUST A PROCESS SO
IT CAN MOVE QUICKER.
WE'RE OPTIMISTIC IT'S A PRIORITY
FOR THE ADMINISTRATION.
HOPEFULLY WE'LL SEE ONE IN THE
NEAR FUTURE.
>> WE KNOW THIS IS A HIGH
PRIORITY.
IT IS MOVING FORWARD.
AGAIN, IT'S A PRESIDENTIAL
APPOINTMENT AND OBVIOUSLY
THERE'S STEPS THEY TAKE AT THE
WHITE HOUSE WE'RE NOT PRIVY TO.
WE'RE HOPEFUL THIS WILL MOVE
FORWARD.
>> I'M PRETTY SURE THEY PUT ME
IN THIS POSITION TO SPEED THINGS
UP BECAUSE THEY'RE LIKE MY GOD
LOOK WHAT THEY'RE DOING IN
ABSENCE OF A DIRECTOR.
>> ADAM, WE SHARE THAT ROLE, AS
YOU KNOW, AND I THINK MAYBE
WE'LL BE REALLY EFFECTIVE.
WE'LL SEE.
IT'S A TREMENDOUS OPPORTUNITY
FOR THE RIGHT PERSON.
WE LOOK FORWARD TO WELCOMING THE
INAUGURAL DIRECTOR.
BARBARA YOU BRING UP SO-CALLED
PROVOCATIVE QUESTIONS FROM NCI.
MAYBE YOU CAN ELABORATE.
>> I MAY NOT BE THE BEST PERSON
TO DO IT BUT I HAD SOME
FAMILIARITY WITH IT A DECADE
AGO.
NCI'S HAD A CUSTOM OF PUTTING UP
A SET OF PROVOCATIVE QUESTIONS
FOR PEOPLE TO SHOOT AT AND
POTENTIALLY WRITE GRANTS AND
RESPECT TO ARPA-H AND A LITTLE
BIT OF CROWD SOURCING ABOUT
PROVOCATIVE QUESTIONS MAY BE AN
INTERESTING BIN FOR FOCUS.
THESE ARE THE KINDS OF THINGS
THAT ARE NOT THE USUAL LINES OF
RESEARCH.
I REMEMBER ONE P.Q. ABOUT CANCER
SO SIMPLE AND YET SO DIFFICULT.
WHY DO PATIENTS ACTUALLY DIE.
IT'S NOT SO SIMPLE AND THERE WAS
A HOST OF FOCI.
>> MIKE LAUER PUT A LINK TO THE
PROVOCATIVE QUESTIONS.
>> YOU CAN GET CURRENT ONES.
>> OTHER COMMENTS OR QUESTIONS?
>> I KNOW YOU PROBABLY HAVE
INSIGHT INTO THE QUESTION ABOUT
THE STIMULUS.
>> THE RECOVERY ACT STIMULUS.
THERE WAS A LONG LIST OF THINGS
SUPPORTED DURING THAT TIME.
SOME WORK TOOK HOLD AND
CONTINUES TO THIS DAY AND OTHER
THINGS THAT WAS A GREAT IDEAS
DIDN'T PAN OUT.
THE BEAUTY OF THE RECOVERY ACT
IT ALLOWED SO MANY NEW IDEAS TO
COME IN AT ONCE.
AND I DON'T HAVE THE EXPERIENCE
ADAM OR TARA HAD IN THIS SPACE
BUT THE BAR SEEMS HIGHER HERE
REFERRING TO THE QUESTIONS THAT
NEED TO BE ADDRESSED AND SO
FORTH.
I CAN SEE SOME COMMONALITIES.
>> BEFORE I LEFT DARPA SOME
SPENT TIME ON THE CREATIVITY AND
PUT IN PLACE SYSTEMS TO GAMIFY
THIS AND ENGAGE AND THE FACT
DARPA IS SEEING THAT AND I'M
GOING TO TRY TO GET TIME ON YOUR
SCHEDULE AND ANYONE WHO WANTS TO
TALK OF WAYS TO DO THIS AND WE
DON'T WANT TO END UP LIKE DARPA
IN WHAT DO WE DO NOW.
>> GREAT.
ADAM, THE COUNCIL HAS BEEN A
TREMENDOUS SOURCE OF KNOWLEDGE,
IDEAS AND SO FORTH.
I APPRECIATE YOU'RE WELCOMING OF
THEIR REACHING OUT TO YOU FOR
ANY SUGGESTIONS OR INPUT THEY
MAY OFFER.
I THINK WE'LL FIND WE'RE
OUTSTANDING PARTNERS
REPRESENTING BROAD SECTIONS OF
THE COUNTRY AND DIFFERENT
DISCIPLINES AND SO FORTH.
WE'RE ABOUT AT THE TIME WE'RE
SUPPOSED TO TAKE A BREAK.
I PRESUME YOU'LL USE THIS AS A
LUNCH BREAK.
NOT SURE WHAT I WILL DO WITH IT
ON THE WEST COAST BUT WE'LL
FIGURE THAT OUT.
MAYBE I'LL CATCH UP ON E-MAIL.
I WANT TO THANK YOU ALL FOR WHAT
I HOPE YOU THINK SAY GOOD
MORNING SECTION AND RECONVENE AT
1:30 P.M. EAST COAST TO HEAR AN
UPDATE FROM TONY AND THEN THE
REMAINDER OF THE PROGRAM AS
OUTLINED.
THANKS EVERYBODY AND WE'LL
RECONVENE AT 1:30.
>>NEXT WE WERE HEAR TO TONY
AND COULDN'T JOIN US FOR THE
WHOLE TIME SO HE RECORDED IT AND
HE'LL JOIN US FOR QUESTIONS AND
REMARKS.
WE'LL GET TO INTERACT LIVE BUT
THE SESSION WAS PRERECORDED A
DAY OR SO AGO.
IF THE TEAM COULD QUEUE UP
DR. FAUCI'S PRESENTATION.
THAT WOULD BE GREAT.
>> GREETINGS, EVERYONE'S A GREAT
PLEASURE TO PROVIDE THE ACD WITH
AN UPDATE ON THE COVID-19
PANDEMIC.
LET'S GET ON WITH THE DATA AND
LOOK AT WHERE WE ARE NOW AND
WHERE WE'RE PROJECTED TO BE.
THE DATA AGAIN ARE REALLY RATHER
SOBERING AS WE ALL KNOW.
GLOBALLY WE'RE NOW OVER HALF A
BILLION CASES WITH MORE THAN 6.2
MILLION REPORTED DEATHS.
THE DEATH TOLL IS LIKELY ONE OF
OR TWO FOLD GREATER THAN THAT
ACCORDING TO THE W.H.O.
PROJECTIONS CLOSER TO 15 MILLION
DEATHS IN THE U.S. WE HAVE GONE
OVER THE TERRIBLE LANDMARK OF 1
MILLION DEATHS AS SHOWN ON THE
RIGHT SIDE WITH THE DARKNESS OF
THE BLUE COLOR INDICATING THE
INCREASE AND DENSITY OF CASES
PER 100 TRIES TO AS DISTRIBUTED
ACCORDING TO THE MAP.
IT'S BEEN TRULY A ROLLER COASTER
EFFECT SINCE THE BEGINNING OF
THE OUTBREAK.
THE FIRST PERIOD OF TIME WITH
REGARD TO CASES WAS WITH OMICRON
WHICH I'LL GET TO AS WE LOOK AT
THE PEAKS AND WHAT VARIANT THEY
REPRESENT.
WE WERE HAVING 800,000 TO
900,000 CASES PER DAY.
RIGHT NOW WE'RE DOWN AROUND
100,000 CASES A DAY IMPORTANTLY,
IF YOU LOOK AT THE DEATHS PER
DAY IN PRIOR SURGES THEY WERE
MORE REFLECTIVE OF THE NUMBER OF
CASES WHERE IF YOU LOOK AT ON
THE FAR HAND RIGHT PART OF THE
SLIDE THOUGH WE HAVE A LOT OF
CASES SURGING THE RATIO OF
HOSPITALIZATIONS AND DEATHS TO
CASES IS MUCH LOWER.
AND WE HAD LESS TOTAL NUMBER OF
CASES.
BOTTOM LINE LESS
HOSPITALIZATIONS.
WE CONTINUE TO HAVE A DISPARITY
OF A GREATER PROPENSITY TOWARDS
SEVERITY IN MINORITY GROUPS.
IF YOU LOOK AT THE GRAY BAR
WHICH IS THE STANDARD OF THE
WHITE POPULATION AND LOOK AT THE
FOLD INCREASE IN CASES,
HOSPITALIZATIONS AND DEATHS
AMONG BLACKS IN DARK BLUE,
HISPANICS IN RED, AMERICAN
INDIAN OR ALASKAN NATIVES IN
LIGHT BLUE, IT'S CLEAR WE
CONTINUE TO HAVE THIS DISPARITY
WHEN IT COMES SEVERITY OF
DISEASE.
CHILDREN ARE CLEARLY AFFECTED.
THERE HAD BEEN THIS FEELING IF
NOT EXPRESSED CONCERN THAT WE
WERE OVER EMPHASIZING THE
SITUATION WITH CHILDREN AND
THEIR RISK OF INFECTION AND/OR
DISEASE WAS VERY LOW.
CERTAINLY IT IS LOWER THAN IN AN
ADULT PARTICULARLY ELDERLY
ADULTS, BUT CHILDREN CLEARLY ARE
VULNERABLE NOT ONLY TO INFECTION
AS SHOWN, BUT THE FACT THERE'S
BEEN OVER 15 MILLION CASE IN
CHILDREN AND OVER 8,000 CHILDREN
HAVE EXPERIENCED THE VERY
SERIOUS MULTI-SYSTEM
INFLAMMATORY SYNDROME.
THERE HAVE BEEN OVER 1500
DEATHS.
THE DEATHS FROM COVID AMONG
CHILDREN ARE CLEARLY GREATER
NUMERICALLY THAN THE NUMBER OF
DEATHS WE GET PER YEAR WITH
CHILDREN WITH INFLUENZA.
THOSE SURGES YOU SAW WERE
ASSOCIATED WITH THE EMERGENCE OF
DIFFERENT VARIANTS.
HERE'S THE VARIANTS SHOWING THE
DATES IN WHICH THE EARLIEST
DOCUMENTED SAMPLES OF THAT
VARIANT WAS SEEN.
WE ARE CURRENTLY NOW IN AN
OMICRON VARIANT BUT A VARIANT
FROM SEVERAL STANDPOINTS.
IF YOU LOOK AT THE IT VARIATIONS
AND COMPARED DELTA ON THE LEFT
WITH OMICRON ON THE RIGHT, THE
NUMBER OF MUTATIONS ARE CLEARLY
MUCH MUCH GREATER.
A TOTAL OF 50.
30 OF WHICH IN THE SPIKE PROTEIN
AND ABOUT A DOZEN OR SO ARE IN
THE RECEPTOR BINDING DOMAIN
MAKING IT A MUCH MORE
TRANSMISSIBLE THOUGH APPARENTLY
LESS SEVERE TO THE POINT OF NOT
CAUSING SERIOUS DISEASE AND
DEATH IN VULNERABLE INDIVIDUALS
WHICH CLEARLY WE'LL SHOW YOU IN
A MOMENT WHY THAT'S THE CASE AND
SHOWN IN THE DEATH NUMBER OF A
PRIOR SLIDE, OMICRON, THOUGH
MORE HIGHLY TRANSMISSIBLE
APPEARS TO BE LESS SEVERE THAN
WHAT WE EXPERIENCED WITH DELTA.
BUT IF YOU LOOK AT THE SO-CALLED
FAMILY TREE, YOU CAN SEE THAT
ALTHOUGH OMICRON CAME WAY OUT
FROM THE ALPHA, BETA, LAMBDA AND
THE ORIGINAL WUHAN WE'RE SEEING
THE SUCCESSIVE LINEAGES WITHIN
THE OMICRON VARIANT.
THAT'S WHAT A CIRCLED IN RED AND
IT'S BEEN AN INTERESTING
EVOLUTION IN THE UNITED STATES
AND OTHER COUNTRIES I'LL SHOW
YOU IN A MOMENT.
WHEN YOU HAVE A VARIANT WITH ANY
DEGREE OF VARIANT IT THE PUSHES
THE PRIOR VARIANT OFF THE MAP
AND REPLACE IT AS WE SEE WHAT
DELTA DID OVER TIME TO ALPHA,
BETA AND GAMMA AND WITH OMICRON
WHICH WAS MUCH DIFFERENT AND
RAPIDLY PUSHED DELTA OFF THE MAP
AS SHOWN HERE IN THE TIME COURSE
OF THE VARIANT DISTRIBUTION.
SO LET'S GET BACK TO THE
DIFFERENT VARIANTS AND SHOW HOW
THEY COINCIDED WITH THE SURGES
WE'VE SEEN GLOBALLY.
AS YOU CAN SEE GOING FROM MARCH
1, 2020 UNTIL THE ENDS OF MAY,
WE HAD THESE PEAKS, WHICH DEATH
WAS ASSOCIATED IN A HIGHER
DEGREE PARTICULARLY WITH DELTA
BUT OMICRON, NUMERICALLY IN
NUMBER OF CASES WAS THE LARGEST
SPIKE WE HAVE SEEN.
AS WE MENTION THERE WAS A POINT
THERE WHERE WE WERE CLOSE TO
900,000 CASES PER DAY.
THAT HAD RAPIDLY GONE DOWN BUT
NOW AS WE'RE SEEING AS SHOWN IN
THIS GRAPH FROM THE UNITED
STATES ON THE FAR RIGHT HAND
PART OF THE SLIDE WE'RE SEEING A
NEW SURGE IN CASES BRINGING US
NOW TO AN AVERAGE OF ABOUT
100,000 CASES OR MORE PER DAY
AND ABOUT 300 DEATHS PER DAY.
AGAIN, THE DISPARITY BETWEEN A
LARGE NUMBER OF CASES AND
RELATIVELY FEWER DEATHS BUT 300
DEATHS IS STILL SOMETHING TO BE
TAKEN TO BE SERIOUSLY.
IN THE UNITED STATES FROM LEFT
TO RIGHT YOU HAVE SEEN THE
REPLACEMENT OF ONE SUB LINEAGE
OF OHM FROM THE OTHER GOING FROM
ORANGE 1.1 TO THE LIGHTER PURPLE
BA2 AND TO DARKER PURPLE BA21.1
TAKEN OVER BA2 AND ACCOUNTS FOR
APPROXIMATELY 60% OF THE
ISOLATES WE'RE SEEING IN THE
UNITED STATES.
GO FOR A MOMENT TO SOUTH AFRICA
WHICH EXPERIENCED THE SAME SORT
OF EVOLUTION OF ONE VARIANT TO
ANOTHER.
THEIR EXPERIENCE OF VARIANT BA4
AND BA5 IN SOUTH AFRICA.
WE HAVE APPROXIMATELY LESS THAN
1% OF BA4, BA5 BUT IT'S
GRADUALLY CREEPING UP.
WHETHER OR NOT IT WILL OUT
COMPETE BA2.12.1 WE DO NOT KNOW.
OUR COLLEAGUES IN SOUTH AFRICA
TELL US BA4 AND BA5 ARE OUT
COMPETING OTHERS BUT THE
SEVERITY IS RELATIVELY LOW
COMPARED TO THE PRIOR EXPERIENCE
WITH DELTA.
THIS IS A GRAPHIC DEMONSTRATION
OF THE LATTER OF
TRANSMISSIBILITY.
WHEN YOU LOOK AT THE DIFFERENCE
BETWEEN DELTA AND OMICRON THE
BIG JUMP OF A MULTIFOLD
DIFFERENCE AND GREATER
TRANSMISSIBILITY AS YOU PROGRESS
FROM BA2, BA21.1 AND BA4 AND
BA5.
WHAT IS THIS ALL ABOUT?
WHY ARE WE SEEING AN INCREASE IN
CASES BRINGS US OVER 100,000
CASES PER DAY?
IT RELATES TO THE INCREASED
TRANSMISSIBILITY OF THE
VARIANTS.
NO DOUBT THAT IS THE CASE.
ALSO THERE'S A COMBINATION OF
WANING IMMUNITY EITHER TO PRIOR
INFECTION AND/OR VACCINATION
WITH BOOSTS AND HAVE SEEN PEOPLE
INFECTED PREVIOUSLY OR
VACCINATED GETTING INFECTED.
THERE'S NO DOUBT ABOUT THE
WANING IMMUNITY WE'RE SEEING
FROM NATURAL INFECTION AND FROM
VACCINATION BUT ALSO THIS C
COINCIDES WITH THE GENERAL
FEELINGS IN THE COUNTRY WE WANT
TO PUT THE OUTBREAK BEHIND US
AND THERE'S BEEN A SIGNIFICANT
RELAXATION OF MITIGATIONS WITH
MASKING NOW NO LONGER
COMMONPLACE INDOOR AND A NUMBER
OF PEOPLE INDOOR CONGREGATING IN
BARS AND RESTAURANTS AND IN
PLACES OF ENTERTAINMENT.
LET'S MOVE ON TO THE MEDICAL
MANAGEMENT.
THE MEDICAL MANAGEMENT HAS THREE
COMPONENTS.
THE CONTROL OF SYMPTOMS THAT
DON'T REQUIRE HOSPITALIZATIONS.
THE PEOPLE WHO GET MILD UPPER
RESPIRATORY SYMPTOMS WHO STAY AT
HOME ANYWHERE SEVERAL DAYS TO
WEEKS.
GENERALLY CONTROLLED
ANTI-INFLAMMATORY AND NEXT IS
END ORGAN SUPPORT
HOSPITALIZATIONS WITH DEVICE OR
ECMO AND THEN THERE'S THE
ANTIVIRALS AND IMMUNOMODULATORS.
WE HAVE PUT FORTH TREATMENT
GUIDELINES THAT PHYSICIANS AND
OTHER INTERESTED PARTIES CAN
ACCESS ONLINE AND LOOK AT THE
LATEST DATA AS IT UNFOLDS IN
REAL TIME.
IT'S A VALUED RESOURCE AND THE
NIH GUIDELINES HAVE RESOURCED
MILLIONS OF HITS THROUGHOUT THE
WORLD OF PEOPLE UTILIZING IT TO
TREAT AND MANAGE PATIENTS.
IF ONE LOOKS AT THERAPEUTICS
THERE'S TWO APPROACHES, ONE TO
DIRECTLY TARGET THE VIRUS AND WE
HAVE A NUMBER OF INTERVENTIONS.
ONE OF WHICH IS FULLY FDA
APPROVED AND OTHERS AND THE ONLY
ONE STILL EFFECTIVE AGAINST THE
OMICRON IS THE BEBTELOVIMAB AND
MODERATING A HOST RESPONSE
USUALLY LATE IN THE COURT THAT
UTIL
UTILIZE DEXAMETHASOME AND
TOCL
TOCLIZUMAB.
I PUT UP THE TOOL KIT FOR
NON-HOSPITALIZED PATIENTS.
THE CRITICAL ISSUE ARE
INTERVENTIONS ARE TO KEEM PEOPLE
OUT OF THE HOSPITAL AND TREAT
THEM EARLY IN THE COURSE OF
INFECTION.
THERE'S A NUMBER OF
INTERVENTIONS HERE THE MOST
EFFECTIVE OF WHICH AND THE EASE
OF ADMINISTRATION OF WHICH IS
PAXLOVID.
IN ADDITION, WE HAVE THE
RECENTLY SHOWN TO BE EFFECTIVE
AGAINST THE OMICRON VARIANT THE
MONOCLONAL ANTI
MONOCLONAL ANTIBODY.
THERE ARE SITES NOW AT LEAST
2200 AND MORE TO COME IN WHICH
ONE CAN GET TESTED ON THE SPOT
IF POSITIVE WITH AN ANTIGEN TEST
TO GET AT THE TIME IN REAL TIME
PAXLOVID TO BE ADMINISTERED.
TREATING EARLY ON IS EFFECTIVE.
WE HAVE MULTIPLE VACCINES.
WE HAVE THE mRNA VACCINES AND
THE J & J WHICH IS NOT UTILIZED
AS MUCH NOW IN THE UNITED STATES
AND THEN WE HAVE OTHERS THAT IS
THE ASTRAZENECA AND NOVA VAX IN
DIFFERENT LEVELS OF DEVELOPMENT
AND IN CERTAIN SITUATIONS WITH
THE EUAs ALREADY GRANTED.
IF YOU LOOK AT THE EFFECT OF
VACCINES, IT'S EXTRAORDINARY.
I COULD SHOW YOU 15 SLIDES OF
THE DIFFERENCES BETWEEN
INDIVIDUALS WHO ARE VACCINATED
AND BOOSTED VERSUS UNVACCINATED
INDIVIDUALS.
ON THE AFFECT OF VACCINATIONS IN
PREVENTING INFECTION TO SOME
EXTENT BUT CERTAINLY
HOSPITALIZATIONS AND DEATHS IT'S
ESTIMATED THAT BETWEEN DECEMBER
OF 2020 AND MARCH OF 2022 OVER 2
MILLION DEATHS WERE AVERTED,
MORE THAN 17 MILLION
HOSPITALIZATIONS WERE AVERTED,
MORE THAN 66 MILLION INFECTIONS
WERE AVERTED AND HEALTH CARE
COSTS APPROXIMATING $900 BILLION
HAVE BEEN SAVED.
THAT'S THE GOOD NEWS.
THE SOBERING NEWS IS WE NEED TO
DO BETTER ON GETTING PEOPLE
VACCINATED.
AND 71% OF INDIVIDUALS 5 YEARS
OF AGE ARE VACCINATED AND WE'RE
DOING BETTER WITH THE ELDERLY
WITH OVER 91% FULLY VACCINATED.
WE MUST DO BETTER AS A COUNTRY
WE ARE LAGGING BEHIND LOW AND
MIDDLE INCOME COUNTRIES AS
PERCENTAGE OF POPULATION THAT
ARE VACCINATED.
THERE WILL BE A MEETING OF THE
MODERNA REQUEST OF CHILDREN OF 6
YEARS TO 17 YEARS AND THE
BIONTECH IS APPROVED AND
THERE'LL BE A REQUEST FOR THE
YOUNGER AGE GROUPS, 6 MONTHS
THROUGH 5 YEARS OF AGE AND THE
BIONTECH EUA REQUEST FOR
CHILDREN 6 MONTHS THROUGH FOUR
YEARS OF AGE.
SO IN THE NEXT COUPLE OF WEEKS
THERE'LL BE A LOT OF AC -- A
LOT OF REQUESTS.
AND IN ADDITION TO HOW POORLY WE
DO COMPARED TO MIDDLE AND
LOW-INCOME COUNTRIES, 87% OF
PEOPLE IN THE MIDDLE-INCOME
COUNTRIES HAVE A PROTOCOL WHERE
IT'S 67%.
THE BAD NEWS ABOUT THIS SLIDE IS
THAT IF YOU LOOK AT THE LOWER
INCOME COUNTRIES PARTICULARLY
SOUTHERN AFRICAN COUNTRIES WE'RE
STILL AT A LOW LEVELS AND SO
MANY REASONS AND INITIALLY THE
SUPPLY AND THERE'S TWO ELEMENTS
TO THE BOOSTER SITUATION.
THE FIRST IS THE INITIAL BOOST
OVER AND ABOVE THE PRIMARY
REGIMENT.
THAT WOULD BE A THIRD SHOT FOR
AN mRNA REGIMENT AND TWO SHOTS
AND THE FOURTH SHOT OR THE
SECOND BOOST OF THAT REGIMENT.
LET'S TAKE A LOOK AT THE INITIAL
BOOST OR THE THIRD SHOT FIRST.
THE COMMUNITY AGAINST THE
VACCINE AND THE INITIAL EFFECT
WAS 94% TO 95% EFFICACY AGAINST
SYMPTOMATIC DISEASE HAS WANED
OVER TIME WITH ALL THREE OF THE
EFFECTIVE VACCINES WE USE IN
THIS COUNTRY.
JOHNSON, MODERNA AND THE PFIZER,
BIONTECH AND THE REAL WORLD
STUDIES HAVE SHOWN IF YOU GIVE A
THIRD SHOT BOOSTER DOSE IT DOES
RECONSTITUTE WANING IMMUNE
PROTECTION AT LEAST FOR A
SEVERAL MONTH DURATION AND THE
EFFECT OF THE BOOSTER DOSE IS
MOST PRONOUNCED AGAINST SEVERE
DISEASE, HOSPITALIZATIONS AND
DEATHS.
I'VE ALLUDED TO THAT MULTIPLE
TIMES WHEN YOU LOOK AT
EPIDEMIOLOGY IN THE COUNTRY IN
THE ERA OF OMICRON AND SEVERITY
OF DISEASE AND DEATH IS LOWER
PROPORTIONATELY TO INFECTION.
HERE'S THE AFFECT OF
UNVACCINATED INDIVIDUALS IF YOU
LOOK AT THE RATE OF
HOSPITALIZATIONS IN 100,000S IN
RED COMPARED TO FULLY VACCINATED
IN DARK BLUE AND FULLY
VACCINATED WITH AN ADDITIONAL
BOOST.
THIS IS VACCINATED TO FULLY
VACCINATED TO FULLY VACCINATED
WITH A BOOST.
IF YOU LOOK AT IMPACT OF BOOSTER
DOSES AND FROM ANOTHER
PERSPECTIVE, IF YOU LOOK AT DATA
FROM MARCH 2022 IN WHICH OMICRON
CLEARLY WAS THE PREDOMINANT
VARIANT, UNVACCINATED PEOPLE
AGED 18 AND OLDER HAD A
FIVE-FOLD INCREASED RISK OF
COVID-19 ASSOCIATED
HOSPITALIZATIONS AND THOSE 12
AND OLDER HAD A 17 FOLD
INCREASED RISK OF THOSE DYING
AND BOOST EXPAND THE ELIGIBILITY
FOR THE PFIZER BIONTECH TO GIVE
A VACCINE BOOSTER DOSE FOR
CHILDREN 5-11 YEARS OLD.
THIS SOMETHING WE NEED TO
CONTINUE TO PUSH FOR PEOPLE TO
GET CHILDREN FOR THEIR PRIMARY
VACCINATION AS WELL AS FOR
BOOSTERS.
WHAT ABOUT CONSIDERATION FOR A
SECOND BOOSTER SHOT.
HERE'S THE DATA SUMMARIZED IN
BULLET FORM.
THE FIRST BOOSTER RESTORES THE
WANING VACCINE EFFECTIVENESS OF
THE PRIMARY SERIES INCLUDING
AGAINST SEVERE DISEASE AND
HOSPITALIZATION AS I MENTIONED.
HOWEVER, THE EFFECTIVENESS OF
THE FIRST BOOSTER DOSE ALSO
WANES OVER TIME AND GROWING
EVIDENCE INDICATES A SECOND
COVID-19 VACCINE BOOSTER CAN
RESTORE VACCINE EFFECTIVENESS
FOR CERTAIN POPULATIONS AT LEAST
IN THE SHORT TERM.
THE DATA FROM ISRAEL CLEARLY
SHOW THE BENEFIT OF THE FOURTH
DOSE.
THESE ARE A NUMBER OF STUDIES, A
MILLION INDIVIDUALS 60 YEARS AND
OLDER THE ADDITIONAL BOOST
OFFERED PROTECTION AND
PROTECTION DID WANE OVER SIX
MONTHS IN A STUDY FROM ISRAEL
THE RELATIVELY EFFECTIVENESS OF
A FOURTH VACCINE DOSE AGAIN OVER
A SHORTER PERIOD OF TIME SHOWED
61% EFFECTIVENESS AND 72% VERSUS
HOSPITALIZATION, 64% VERSUS
SEVERE DISEASE AND 66% IN
COVID-RELATED DEATHS.
ANOTHER WAY OF LOOKING AT THE
DATA IF YOU LOOK AT MORTALITY
RATES OF ACCUMULATIVE INCIDENTS
OF MORTALITY RATES AND LOOK AT
THE VACCINATED GROUP WHO
RECEIVED THE FIRST BOOSTER
COMPARED TO THOSE WHO RECEIVED
THE SECOND BOOSTER, THE FIRST
BOOSTER IN BLUE, THE SECOND IN
TAN OF POSITIVE IMPACT ON
PREVENTING DEATHS.
THE CDC RECOMMENDATIONS
ADDITIONAL BOOST FOR CERTAIN
INDIVIDUALS 50 YEARS OF AGE OR
OLDER AND THE C.D.C.
STRENGTHENED THAT RECOMMENDATION
BY SAYING INSTEAD OF JUST
ELIGIBLE FOR THE FOURTH BOOST
THEY RECOMMEND THAT PEOPLE 50
YEARS OF AGE OR OLDER SHOULD GET
THE BOOST.
IF YOU LOOK AT THE AGE GROUP AND
THE VACCINE DOSE ELIGIBILITY
WITH THE ORIGINAL DOSES, THE
SECOND DOSES AND THIRD AND
FOURTH DOSES THIS IS WHAT WE
HAVE ELIGIBLE NOW AND IT'S NOT
YET ELIGIBLE 0 TO 4.
5 TO 11 YOU CAN GIVE THE FIRST
PRIMARY SERIES WITH PFIZER THE
SECOND DOSE AND A MENTIONED
RECENTLY A THIRD DOSE BOOST HAS
BEEN APPROVED, THE FOURTH DOSE
NOT.
YOU CAN SEE INDIVIDUALS ARE
RECOMMENDED FOR THE BOOSTERS
SHOWN HERE FROM 12 TO 49 THE
FOURTH DOSE IN INDIVIDUAL WHO'S
ARE SEVERELY IMMUNOCOMPROMISED.
IN 50 OR OLDER, ALL INDIVIDUALS
IN THAT GROUP HAVE RECOMMENDED
TO GET ALL OF THE AVAILABLE
BOOSTER SHOTS INCLUDING THE
FOURTH DOSE.
WE'RE DOING A STUDY HERE AT
NIAID OF WHAT PARTICULAR BOOSTER
SHOULD BE USED FOR THE FOURTH
DOSE.
THIS LOOKS AT BIVALENT COMPARED
TO USING AN OMICRON SPECIFIC, A
WILD TYPE SPECIFIC OR
COMBINATION OF THE BOTH AS WELL
AS LOOKING AT OTHER PLATFORMS
SUCH AS SOLUBLE PROTEINS WITH
ADJUVANTS.
THOSE STUDIES ARE ONGOING RIGHT
NOW AND THE POWER OF THE STUDY
ISN'T ENOUGH TO GIVE US CLINICAL
DATA BUT WE NEED TO KNOW QUICKLY
WHAT THE IMMUNE BRIDGING ARE TO
MAKE A DECISION AS WE APPROACH
THE FALL IN WHAT WE'LL BE
RECOMMENDING OR THE C.D.C. WILL
BE RECOMMENDING FOR THE FOURTH
DOSE.
LET ME CLOSE BY LOOKING AT THE
FUTURE OF WHERE WE ARE NOW.
UNIVERSAL CORONAVIRUS VACCINES
WE HAVE AN URGENT NEED FOR.
I ARTICULATED THAT IN A PAPER
FROM DECEMBER 2021 FOR THE
REASONS I'VE SHOWN YOU.
WE'VE HAD THREE CORONAVIRUS
MAJOR DISEASE, SARS, MERS,
COVID-19.
SINCE SEPTEMBER 2020 WE'VE HAD
FIVE SARS COV2 VARIANTS EMERGING
FROM A SINGLE VIRUS, THE SARS
COV2.
AND INNOVATIVE APPROACHES ARE
NEEDED TO PRODUCE BROAD AND
DURABLE PROTECTION AGAINST
CORONAVIRUS WE KNOW ABOUT AND
DON'T KNOW ABOUT YET THAT MAY BE
LOOKING IN THE FUTURE.
IF YOU LOOK AT THE PHYLOGENETIC
TREE OF THE CORONAVIRUS, THE
HUMAN CORONAVIRUSES HAVE A RED
FONT AND IN THE YELLOW ARE ALL
THE VIRUSES THAT WE NOW HAVE
EXPERIENCED.
LET'S TAKE A LOOK AT SARS COV2,
THE FIRST STAGE IS TO GET A PAN
SARS COV2 THAT WILL GET ALL THE
VARIANTS.
THE NEXT STAGE WOULD BE TO GO
BEYOND THAT AND GET THE CERTAIN
BAT VIRUSES THAT MAY JUMP
SPECIES AS HAS BEEN THE CASE IN
THE PAST AS WELL AS THE VIRUS
THAT CAUSED SARS COV1 AND THE
PAN BETA CORONAVIRUS.
THE EXAMPLES OF WHERE WE ARE NOW
AND ALREADY DOING WE'RE USING
NANO PARTICLE WITH DIFFERENT
SPIKE PROTEIN FRAGMENTS GIVING
DIVERSE ANTIBODY RESPONSE.
THERE'S STUDIES LOOKING AT
INTRANASAL MIST DELIVERY OF
VACCINES AS PART OF THE
UNIVERSAL BETA CORONAVIRUS
VACCINE CONCEPT TO GIVE MORE
BROAD PROTECTION AGAINST HUMAN
AND ANIMAL BETA CORONAVIRUSES.
AND PREPARE FOR OTHER PANDEMIC
THREATS.
THIS IS A SCHEMATIC OF THE
REPLICATION CYCLE AND ANTIVIRALS
WHERE WE TARGET REPLICATION
CYCLES OF THE VIRUS.
CLOSING UP, WHAT'S THE END GAME
FOR 2022 AND BEYOND, WHERE ARE
WE GOING?
THERE'S THE ACUTE PANDEMIC PHASE
AND THE DECELERATION, WHICH
YOU'VE EXPERIENCED AND THEN
CONTROL, ELIMINATION OR
ERADICATION.
LET'S TAKE A LOOK AT THIS.
WE'VE BEEN THROUGH THE FULL
PANDEMIC PHASE.
WE'VE SEEN DECELERATION OF NEW
CASES.
WHERE ARE WE GOING TO GO WITH
THE NEXT THREE?
LET'S LOOK AT ERADICATION.
WE'RE NOT GOING TO ERADICATE THE
VIRUS.
THE ONLY VIRUS WE'VE EVER
ERADICATED IS SMALLPOX AND THE
REASON IS IT'S A PHENOTYPICALLY
A SMALL VIRUS AND THE SMALLPOX
IS THE SAME WE HAD 100 YEARS
AGO.
WIDELY ACCEPTED GLOBAL
VACCINATION CAMPAIGN WAS USED
AND THE DURABILITY OF
VACCINATION AND INFECTION
INDUCED IMMUNITY IS VIRTUALLY
LIFE LONG.
THAT'S WHY WE WERE ABLE TO DO
THE ERADICATION OF SMALLPOX.
ELIMINATION OF POLIO AND MEASLES
THERE IS NO ANIMAL RESERVOIR AND
PHENOTYPICALLY STABLE AND WE
HAVE FEW PHENOTYPIC CHANGES.
WE HAVE A WIDELY ACCEPTED
NATIONAL VACCINE CAMPAIGN AND
THE DURABILITY OF INFECTION
INDUCED IMMUNITY IS MEASURES IN
DECADES AND PERHAPS LIFE LONG.
WHEN WE GET TO SARS COV2 THERE'S
ESTABLISHED ANIMAL RESERVOIRS
AND WE'VE HAD JUMPS OF
CORONAVIRUS WITH SARS AND MERS
AND CERTAINLY WITH SARS COV2.
THEN THE EVOLUTION OF
PHENOTYPICALLY VARIANTS.
UNFORTUNATELY WE HAVE LACK OF
WIDE ACCEPTANCE OF EFFECTIVE
VACCINE AND THEN A FACT OF LIFE,
VACCINE AND INFECTION-INDUCED
IMMUNITY WANES AS I'VE SHOWN YOU
ON SEVERAL SLIDES.
SO WHAT ARE WE LOOKING AT?
WE'RE TRYING TO CONTROL AND LIVE
WITH THE VIRUS AT A LOW LEVEL
THAT DOES NOT DISRUPT IT.
SOME REFER TO THIS AS YOU LOOK
AT THE RIGHT HAND PART OF THE
SLIDE AS THE RETURN TO NORMALCY
OR SOME REFER REFER TO IT WITH
ENDEMICITY AND THE LEVEL OF
CONTROL MUST BE LOW ENOUGH TO
NOT DISRUPT US AND CREATE SUCH A
DEGREE OF MORBIDITY AND
MORTALITY.
WE'LL REQUIRE VACCINATION
BECAUSE OF THE REASONS I'VE
ARTICULATED THROUGHOUT THE TALK
INCLUDING AND PARTICULARLY THE
WANING IMMUNITY.
WE WANT TO GET BETTER VACCINES
OBVIOUSLY THAT GIVE US A GREATER
DURABILITY OF IMMUNITY AND A
GREATER BREADTH.
WE'LL ALSO HAVE TO USE COMMON
SENSE APPROACHES LIKE VOLUNTARY
MASKING WHERE APPROPRIATE AND
ATTENTION TO BETTER VENTILATION
AND THE FORM OF ANTIVIRALS AND
MONOCLONAL ANTIBODIES.
WE CAN GET THERE.
THIS WILL NOT LAST FOREVER BUT
WE'LL HAVE TO LEARNED.
I'VE TALKED ABOUT THE CHALLENGE
OF EMERGING INFECTIONS.
IT'S CLEAR WE'VE ALWAYS HAD
OUTBREAKS OF PANDEMICS.
WE'RE IN THE MIDDLE OF A
HISTORIC ONE NOW AND THERE WILL
BE FUTURE ONES THEREFORE WE MUST
LEARN LESSONS FROM THE
SCIENTIFIC PREPAREDNESS WHICH
HAS BEEN QUITE SUCCESSFUL AS
WELL AS A MUCH BETTER PUBLIC
HEALTH PREPAREDNESS AS WE LOOK
FORWARD TO COOPERATING WITH
OTHER COUNTRIES IN THE WORLD TO
USE THE LESSONS WE LEARNED TO
PREVENT THIS FROM EVER HAPPENING
AGAIN.
THANK YOU.
>> WE HAVE A QUEUE OF QUESTIONS
PEOPLE SEND TO ME.
>> THANK YOU FOR YOUR HEROIC
EFFORTS ON BEHALF OF THE
AMERICAN PEOPLE AND PEOPLE
WORLDWIDE.
I'M CONCERNED ABOUT THE GREATER
IMPACT OF COVID ON OUR NATIVE
AMERICAN POPULATIONS AND WONDER
WHAT THE POTENTIAL OF AN ARPA-H
EFFORTS THAT TARGETS THESE UNDER
SERVED POPULATIONS.
>> YOU'RE BREAKING UP.
>> ROBERTA, THERE'S A SPECIFIC
COMPONENT OF THE HHS EFFORT TO
ADDRESS NATIVE AMERICANS AND
ALASKAN NATIVE AND PACIFIC
ISLANDERS.
THAT'S SOMETHING WE HAVE A TASK
FORCE IN THE DEPARTMENT AND
STARTED FROM THE BEGINNING.
CAMERON WEBB IS NOW THE PERSON
IN THE DEPARTMENT RESPONSIBLE
FOR THAT AND IT IS BEING
ADDRESSED.
I'M NOT SURE WE NEED AN ARPA-H
FOR IT, WHATEVER THAT IS BUT WE
ARE ADDRESSING IT.
>> THANK YOU.
THE TECHNOLOGICAL ISSUE, THE
INTRANASAL POTENTIAL IS THERE
CONCERN THERE'S CROSSOVER INTO
THE BRAIN?
IT WILL UNLIKELY BE A LIVE
VACCINE AND I BELIEVE THE
ATTENUATION WILL NOT HAVE
REPLICATION TO ALLOW IT TO KIND
OF THE DIFFICULT WE'RE STARTING
TO SEE WITH OLFACTORY BULB
STIMULATION AND INFLAMMATION AND
PERHAPS ENTRY INTO THE BRAIN.
THAT'S AN IMPORTANT SAFETY ISSUE
WHEN YOU DEAL WITH THIS
EXTRAORDINARILY COMPLICATED
VIRUS FOR THE FIRST TIME I'VE
SEEN A VIRUS DOING THIS AND
THERE'S RECENT STUDIES SHOWING
INFLAMMATORY RESPONSES AROUND
THE OLFACTORY BULB WHICH IS
WORRISOME.
YOUR CONCERN IS WELL TAKEN AND
WILL BE A SAFETY CONCERN.
>> I'VE HEARD OF THE REBOUND TO
PAXLOVID INFECTION AND WHETHER
IT'S COMMON.
>> IT'S A CONCERN AND WHAT
PFIZER DID WAS DURING THE DELTA
ERA IF YOU LOOK AT THE WHAT WE
CALL REBOUND AND THAT MEANS
SOMEONE GETS PAXLOVID, THE LEVEL
OF INFECTION THAT IS DETECTABLE
BY ANTIGEN GOES DOWN AND
SYMPTOMS RAPIDLY GO DOWN.
AS SOON AS THE PAXLOVID IS
STOPPED HAVE YOU A REOCCURRENCE
OF SYMPTOMS BUT ALSO HAVE A
PROLONGATION OF THE POSITIVITY
OF THE ANTIGEN TEST AND THE 90%
PROTECTION AGAINST
HOSPITALIZATION STILL WORKS BUT
WHAT WE'RE SEEING WITH OMICRON
IS AN INTERESTING PHENOMENON.
WE DON'T KNOW WHAT THE PERCENT
IS.
WHEN THE PFIZER PEOPLE DID THE
PLACEBO CONTROLLED STUDY THEY
FOUND 2% IN THE PAXLOVID GROUP
AND 1.6% WHICH WAS
NON-STATISTICALLY DIFFERENT.
HOWEVER, WHAT WE'RE SEEING
ANECDOTALLY BUT THE ANECDOTES
ARE REALLY STRONG AND WHAT WE
THINK IS GOING ON PEOPLE ARE
GETTING PAXLOVID SO EARLY
THEY'RE NOT ALLOWING THE BODY'S
IMMUNE RESPONSE TO THE VIRUS
KICK IN SO YOU'RE HAVING NO
COMBINATION IMMUNOLOGICAL
ANTIVIRAL CONTROL JUST THE
VIRUS.
WHEN YOU PULL THE VIREO STATIC
AND NOT THE VIRO STATIC DRUG
AWAY THE IMMUNE SYSTEM TAKES
DAYS TO CATCH UP AND SUPPRESS
THE VIRUS.
THIS IS PURELY SPECULATION -- I
DON'T WANT TO SAY IT'S STANDARD.
THE SPECULATION IS PEOPLE WOULD
WAIT A DAY OR TWO BEFORE THEY
START THE PAXLOVID YOU MAY GIVE
THE IMMUNE SYSTEM A CHANCE TO
REV UP IN RESPONSE TO THE VIRAL
ANTIGEN SO WHEN YOU TAKE IT YOU
HAVE A CONTINUATION OF THE
IMMUNE RESPONSE.
THAT'S THE THOUGHT.
>> THANK YOU.
I SEE.
>> TONY MAYBE THIS IS THE LAST
WORD BECAUSE I KNOW YOU HAVE TO
RUN.
WITH THE NASAL EARLY VACCINE, IS
THERE ENOUGH FUNDING AVAILABLE
TO PROPEL PROMISING CANDIDATES
FORWARD AND IN A TIMELY WAY?
>> LARRY, MAY BE YOU ADDRESSED
THAT IN YOUR OPENING REMARKS BUT
THAT'S AN EASY ANSWER, NO.
>> I WAS AFRAID THAT WAS THE
ANSWER.
WHEN YOU HEAR LARRY AND YOU WILL
OF US TALKING ABOUT WE'RE NOT
KIDDING, WE DO NOT HAVE ENOUGH
MONEY ALL THE MONEY IS ON
VACCINES AND TESTS AND ALL
IMPLEMENTATION AND NOT RESEARCH.
>> I WANTED YOU TO SAY IT LOUD
AND CLEAR RIGHT HERE.
>> HOWARD IS ASKING IF THERE'S
CONCERN FOR IMMUNE EXHAUSTION?
>> YES TO THE FIRST QUESTION, IT
IS IN THE FUTURE.
GIVEN THE INEVITABLE WANING OF
IMMUNITY AS WE SEE WITH THE
NATURAL INFECTION WITH
CORONAVIRUS, WE DO NOT BELIEVE
THERE'S ANY IMMUNOLOGICAL BASIS
TO THINK THERE'S GOING TO BE
IMMUNE EXHAUSTION BECAUSE THE
IMMUNITY DOES WANE.
IT'S AS IF YOU'RE DEALING WITH A
FUNDAMENTALLY NAIVE HOST WHEN
THE IMMUNITY WANES SO LOW AFTER
A WHILE.
>> I'M NOT SEEING OTHER
QUESTIONS.
>> NO.
>> THANK YOU.
>> GOOD TO BE WITH YOU.
BYE-BYE.
>> WE'RE ON TIME.
NEXT UP IS WALTER KOROSHETZ WHO
WILL BE DISCUSSING THE RECOVER
EFFORT INVOLVED WITH POST-ACUTE
SEQUELAE OF SARS COV2
INFECTIONS.
THE FLOOR IS YOURS.
>> THANK YOU.
I'LL TALK ABOUT HOW PERSISTENT
IT CAN BE IN SOME PEOPLE
AFFECTED.
SO THERE'S QUITE A BIT OF DATA
OUT THERE LOOKING AT DIFFERENT
TYPES OF POPULATIONS OVER
DIFFERENT PERIODSI OF TIME.
ALL SHOW PEOPLE INFECTED WITH
COVID A SIGNIFICANT PROPORTION
WILL DEVELOP PERSISTENT TROUBLE
THAT GOES OUT A COUPLE MONTHS,
THIS ONE'S AT SIX MONTHS AND
PEOPLE HAVE BEEN HOSPITALIZED
AND UNFORTUNATELY WE ALSO KNOW
PEOPLE HAVING PERSISTENT TROUBLE
THAT DATES TO THE TIME OF THEIR
INFECTION.
THE PROBLEMS FIT INTO MULTIPLE
DIFFERENT CATEGORIES AND ON THE
NEXT ONE SHOWS MOST PEOPLE HAVE
MORE THAN ONE SYMPTOM THEY OCCUR
IN CLUSTERS.
NOT SURE IF THEY INDICATE
CERTAIN GROUPS OR
PATHOPHYSIOLOGIES BUT THERE'S
REAL INFORMATION THAT INDICATES
IT'S NOT ONE THING AND SOME ARE
DUE TO SAY TISSUE DAMAGE DURING
THE ACUTE INFECTION AND OTHERS
ARE MORE OF A HISTORY AND FALL
INTO CATEGORIES HEAVILY
DOMINATED BY FATIGUE, TROUBLE
WITH CONCENTRATION AND PAIN,
COUGH, ABDOMINAL TROUBLE AND A
LOT OF THESE OVERLAP WITH WHAT
WE'VE SEEN IN THE PAST THAT GOES
UNDER THE TERM CHRONIC FATIGUE
SYNDROME AND STUDIED WE GET THE
STUDY IT STARTED AFTER AN
ILLNESS AND UNFORTUNATELY THIS
CONDITION KNOWN AS LONG COVID
HAS A LOT OF SIMILARITIES.
>> THIS IS HEALTH RECORD DATA
WHERE MOST DATA IS COMING FROM
AND 30 DAYS AFTER INFECTION,
HOSPITALIZATION STATUS IS NOT
DEFINED BIT YOU SUSPECT IT'S
MORE GOING TO BE
NON-HOSPITALIZED PEOPLE BECAUSE
THOSE ARE THE MOST COMMON.
38% OF PREVIOUSLY INFECTED
INDIVIDUALS HAVE ONE OF THE
INCIDENT CONDITIONS YOU SEE HERE
AT ABOUT A MONTH OUT.
THE CONCLUSION IS 1 OF 5
COVID-19 SURVIVES LESS THAN 65
BUT GREATER THAN 16 MAY DEVELOP
A CONDITION ATTRIBUTABLE TO
COVID-19 AND 1 IN 4 FOR THOSE
AGE 65.
SOME HAVE THROMBOLIC EVENT AND
SOME RELATE TO THE LONG COVID
SYSTEMS AND MUSCLE FATIGUE AND
DISORDERS AND PAIN.
THIS IS THE DATA WE HAVE NOW
FROM THE ELECTRONIC HEALTH
RECORDS.
THE U.K. TRACKED PEOPLE WITH
INFECTION AND ABOUT 3% OF PEOPLE
WHO AT 12 WEEKS AFTER ACUTE
INFECTION ARE HAVING SYMPTOMS
RELATED TO THEIR COVID AND THIS
COMPARES TO 11. 7% BASED ON
SELF-CLASSIFICATION OF PEOPLE.
PEOPLE ARE REPORTING THEY'RE
JUST NOT FEELING AS WELL AS THEY
DID BEFORE.
IF YOU LOOK AT THE SYMPTOMS AND
WE SHOWED YOU MANY OF THOSE AND
YOU CAN SEE MANY ARE COMMON IN
THE POPULATIONS SO IF YOU WANTED
TO LOOK AT WHAT'S RELATED TO
COVID OR NOT, THERE ARE SOME
CONFOUNDERS.
IN THE STUDY, 5% OF THE PEOPLE
WITH COVID RELATED ANY OF THE 12
COMMON SYMPTOMS BUT THE
PREVALENCE RATE IS 3.4% IN THE
CONTROL GROUP WHO NEVER HAD
COVID.
THAT'S BECAUSE OF THE COMMON
NATURE OF THE SYMPTOMS.
WHEN YOU LOOK AT 12 WEEKS FROM
INFECTION TYING IT TO THE
INFECTION ITSELF, THERE'S 3% IN
THE COVID COMPARED TO 3.5% IN
THE CONTROL GROUP AND THE
PREVALENCE IS HIGHER IN FEMALES
AND THE CAVEAT IN HOSPITALIZED
PATIENTS IT'S PRETTY MUCH 50/50
BUT WHEN YOU GO TO
NON-HOSPITALIZED PATIENTS
FEMALES HAVE SLIGHT
PREDOMINANCE.
THERE'S SIGNS PREEXISTING HEALTH
SEASON AND SEVERITY OF ILLNESS
AND HIGH VIRAL LOAD OF INFECTION
PREDISPOSED PEOPLE TO DEVELOP
THE SYNDROME.
THE C.D.C. HAS A BILLING CODE
FOR THE POSTCOVID CONDITION AND
THERE'S A STUDY NOW WITH THE USE
OF THE COVID IN A LARGE PRIVATE
ELECTRONIC HEALTH RECORD DATA
THAT HAD 9 MILLION PEOPLE WHO
HAD COVID INFECTION.
IN THAT GROUP 4% HAD A DIAGNOSIS
BETWEEN OCTOBER 1 AND JANUARY 31
AND THE I.C.D. WENT LIVE AND 24%
DIAGNOSED WITH THE CODE WERE
HOSPITALIZED.
75% OF THE PEOPLE POST-COVID ARE
NOT HOSPITALIZED AND THEY MAKE
UP THE MOST THOUGH YOUR CHANCE
OF GETTING A POST-COVID
DIAGNOSIS IS HIGHER.
AND THE HOST COMMON CONDITIONS
ASSOCIATED WITH THE ICD CODE
WERE BREATHING ABNORMALITIES AND
COUGH IN 19% AND MALAISE AND
FATIGUE IN 15.7% AND DIAGNOSIS
OF UNSPECIFIED MYOPATHY AND
CORONARY EMBOLISM AND THIS GIVES
A GLIMPSE TO WHAT WE'RE SEEING.
PERCENTAGE WISE THIS WILL BE A
LARGE NUMBER AND THE PRESIDENT
IN APRIL ANNOUNCED HE WANTS ALL
THE AGENCY TO COME TOGETHER AND
DEVELOP A NATIONAL PLAN FOR
ADDRESSING THE LONG-TERM EFFECTS
AND MANY HAVE BEEN BUSY WORKING
WITH THE AGENCIES ON A RESPONSE
THAT COVERS NOT ONLY RESEARCH
SIDE AND BIOLOGY SIDE AND THINGS
THAT GO INTO CARE AND FINANCES
AND EVEN THE DEPARTMENT OF LABOR
IN TERMS OF THE EFFECTS LABOR
POOL IN THE COUNTRY.
WHAT'S CAUSING THIS?
THERE'S BEEN LOTS OF REPORT BUT
NOTHING REALLY ABLE TO STICK
OVER TIME.
THERE'S NO TREATMENTS WE'VE BEEN
ABLE TO DISCOVER FOR THE CASES
WHICH WE THINK ARE CHRONIC
DISEASES AST INFECTION.
THERE'S LOTS OF PEOPLE LOOKING
AT THIS AND REPORTS IN THE
LITERATURE AND THIS IS ONE THAT
IS SHOWING IG3 LEVELS USUALLY GO
UP IN ACUTE COVID AND PEOPLE WHO
DEVELOP THE LONG COVID WERE
LIKELY TO HAVE LOW LEVELS OF IG3
DURING THEIR ACUTE INFECTION.
AGAIN, THE NUMBERS OF PEOPLE
HERE IN THE LOW HUNDREDS THIS
LOOKS AT HOW GERMANY WHERE THEY
HAD A POPULATION STUDY AND THEY
LOOKED AT AUTOANTIBODIES AND WE
SEE THEM COMMONLY IN PEOPLE
AFTER COVID-19 BUT NO DIFFERENCE
WHETHER YOU HAVE POST-ACUTE
SEQUELAE OF COVID OR NOT.
THEY SEE IN INCREASE IN IL6
LEVELS IN THOSE WHO HAVE
POST-ACUTE SEQUELAE OF COVID.
THIS LOOKS AT WHETHER THE VIRUS
IS PERSISTENT IN PEOPLE AFTER
INFECTION.
THERE'S HUNDREDS OF VIRUSES WE
BECOME INFECTED WITH AND MANY
ARE RESIDENT IN OUR BODIES IN
SOME FASHION.
ZOSTER AND ABV ARE SOME
EXAMPLES.
THE QUESTION IS THERE VIRAL
PERSISTENCE THAT STIMULATES THE
IMMUNE SYSTEM TO CAUSE THE
SYSTEMS WHICH SOUND LIKE THE
KIND OF SYSTEMS YOU DEVELOP WITH
AN ACUTE INFECTION THAT PERSIST
OVER TIME.
THIS IS A PAPER THAT IS IN PRE
PRINT STAGE FROM THE NCI.
I THINK IT WAS 44 AUTOPSIES BUT
80% WERE PEOPLE ON RESPIRATORS
AND WERE EXPECTING TO SEE
MULTIPLE REPLICATION IN TISSUES
THOUGH PEOPLE DIED 230 DAYS
AFTER SYMPTOM ON SET.
THE COPY NUMBER IS LOW IN THE
TISSUES.
THIS IS GOING TO BE A BIG
QUESTION FOR US IN UNDERSTANDING
PERSISTENT INFECTION AND IF
THAT'S THE CASE, IS IT THE CAUSE
OF THE SYMPTOMS THAT PEOPLE ARE
EXHIBITING AND WHETHER AN
ANTIVIRAL CAN SOLVE SOME OF THE
PROBLEM.
WE'RE SEEING LOTS OF STUDIES AND
WE PUT TOGETHER THE RECOVER
INITIATIVE ENGINEERED TO NOT
LEAVE ANY STONE UNTURNED AND
LOOK UNDER EVERY CORNER FOR WHAT
COULD BE CAUSING THE TROUBLE TO
MAKE SURE WHEN DISCOVERIES ARE
ANNOUNCED THEY COULD BE
VALIDATED SO WE KNOW WHAT STICKS
OVER TIME AND MOVE FROM
DISCOVERY TOWARDS TREATMENT.
THAT'S THE GOAL OF THE
INITIATIVE AND THE IDEA IS THE
ANSWER PLAY NOT BE EASY TAKEN
FROM THE LESSONS WE HAVE WITH
THE OTHER POSTINFECTIOUS
CONDITIONS THAT COST PERSISTENT
TROUBLE IN PEOPLE.
THIS IS LED BY NHLBI AND GARY
GIBBONS IS THE HEAD AND AMY
PATTERSON IS THE EISENHOWER OF
THE PROJECT AND WE'VE WORKED
TOGETHER A LONG TIME NOW.
WE STARTED OUT WITH LISTENING
SESSIONS WHERE WE WOULD GET IN
THE EVENING WITH DOCS RUNNING
THE POSTCOVID CLINIC AND HAD
LISTENING SESSIONS AND KEPT OUR
EARS OPEN AND GOT INPUT FROM ALL
SECTORS, PARTICULARLY PEOPLE
SUFFERING WITH THE CONDITION.
WE HAVE LAYERS OF GOVERNANCE AND
THERE'S COMMUNICATION WITH THE
EFFORTS GOING ON OUT OF
LIVERPOOL FOR OUTCOME MEASURES
POST COVID.
WE REACHED OUT BEST WE CAN TO
GET INPUT THE GOAL IS TO LOOK AT
THE PREVALENCE ANDFIDE THE
SUBTYPES -- AND IDENTIFY THE
SUBTYPES AND STUDY IT OVER TIME
AND TO LOOK AT THE OTHER ORGAN
SYSTEM DYSFUNCTIONS THAT COULD
OCCUR 5 YEARS, 10 YEARS DOWN THE
ROAD DUE TO THE FACT SO MANY
PEOPLE IN THE COUNTRY HAVE BEEN
AFFECTED BY COVID.
THE GOAL IS TO TRY TO IDENTIFY
THE BIOLOGY AND INTERVENE AND
TREAT AND PREVENT.
THERE'S MULTIPLE PIECES TO THE
PROGRAM.
THERE'S COHORTS AND ELECTRONIC
HEALTH REPORT STUDIES.
WE ARE PUTTING TOGETHER COHORTS
HOPING TO ENROLL 40,000 PEOPLE.
WE'RE PUTTING TOGETHER STUDIES
OF ELECTRONIC HEALTH SYSTEMS AND
THIS IS IMPORTANT IF WE'RE GOING
TO LOOK 5, 10 YEARS DOWN THE
ROAD LOOKING AT COVID-19
INFECTION AND WE HAVE AUTOPSY
STUDIES LOOKING TO RECRUIT
HUNDREDS OF PERSONS WHO HAVE
DIED FROM WHATEVER CONDITION BUT
PREVIOUSLY HAD COVID-19.
SOME OF WHOM HAVE PASSED AND
SOME NOT TO GO AFTER WHAT WE
TALKED ABOUT EARLIER THE KIND OF
THINGS YOU CAN ALWAYS SEE UNDER
THE MICROSCOPE CAN'T REALLY GET
OUT OF BLOOD OR SALIVA.
IF ANYTHING IS GOING TO GIVE US
QUICK ANSWERS IT'S GOING TO BE
THE AUTOPSY STUDIES.
WE'RE ALSO RIGHT NOW ARE SETTING
UP A PLATFORM TO DO CLINICAL
TRIALS IN PEOPLE WITH POST-ACUTE
SEQUELAE OF COVID AND HAVE A
CALL OUT OF TRIALS AND FUNDING
PATHOLOGY STUDIES OF VARIOUS
TYPES EITHER CLINIC OR
LABORATORY TO TRY TO UNDERSTAND
WHAT IS THE UNDERLYING BIOLOGY
IN PEOPLE WITH PARTICULARLY WITH
LONG COVID.
NOW NOW WE HAVE A NATIONAL SCALE
PLATFORM WITH ADULT COHORTS AND
PREGNANCY COHORTS AN EIGHT
PEDIATRIC COHORTS AND FIVE
AUTOPSY CENTERS.
WE HAVE THE HR STUDIES UP AND
RUNNING ACCESSING 60 MILLION
PATIENT RECORDS.
WE HAVE 200 SITES AROUND THE
COUNTRY.
AS OF THIS WEEK WE HAVE ENROLLED
PARTICIPANTS ACROSS 58 SITES AND
16 PARTICIPANTS IN THE AUTOPSY
COHORT.
IN THE COHORT THERE'S BASICALLY
TWO POOLS OF PATIENTS WE'RE
LOOKING FOR.
WE THINK THAT IT'S MOST
IMPORTANT RIGHT NOW AS THE
INFECTION IS STILL PROMINENT TO
STUDY THE PROCESS TO STUDY THOSE
WHO MAKE A GOOD RECOVERY VERSUS
THOSE WHO DEVELOP PERSISTENT
SYMPTOMS.
IT'S A TIME-SENSITIVE PROJECT
ONCE THE ACUTE INFECTIONS GO
DOWN STUDYING PEOPLE AFTER BEING
INFECTION S MATCH WHO WEREN'T
INFECTED AND WE LOST THE ABILITY
TO SEE THE EARLY STAGE PROCESS
OF RECOVERY UNLESS WE CAN GET
ENOUGH PEOPLE IN THE FIRST GROUP
TO INFORM THESE ISSUES.
WE'RE ALWAYS LOOKING AT PEOPLE
AFTER TROUBLE AND TRYING TO LOOK
AT PREGNANT PERSONS IN BOTH
THESE GROUPS, CHILDREN IN BOTH
GROUPS AND ALSO MISC.
THE STUDY IS SET UP IN MULTIPLE
YEARS.
THE FIRST YEAR IS A SURVEY OF
QUESTIONS, LABORATORY BIO
SPECIMENS EVERYBODY GETS.
WE'RE LOOKING TO DO THAT WITH
17,000 PEOPLE.
THE NEXT YEAR IS LOW RISK
CLINICAL TESTS.
THEY'RE LESS INVASIVE AND POISED
TO LOOK AT PARTICULAR PROBLEMS
AND SLEEP DISORDERS OR EXERCISE
WHICH ARE COMMON PROBLEMS THAT
REQUIRE A DEEPER DIVE THAN IN
THE TIER 1 SPACE AND GOING TO
TIER 2 DEPENDS ON WHAT THE
PATIENT'S PROBLEMS ARE.
YOU SHUN PEOPLE WITH PARTICULAR
PROBLEMS AND IN TIER 2 ARE MORE
ADVANCED TESTING IN THE SPECIFIC
AREAS.
WE SHOULD HAVE AND THERE'LL BE
BIO SPECIMENS AT ALL THESE
LEVELS AND IMAGING FOR ALL THE
LEVELS AND BROUGHT INTO
REPOSITORIES AVAILABLE FOR
SEARCHING AND MINING.
AND JUST TO SAY THE PEDIATRIC
COHORT IS PRETTY SIMILAR BUT
ALSO HAS LOOKING AT BABIES WHO
WERE EXPOSED IN UTERO AND THE
MAIN COHORT THAT LOOKS LIKE THE
ADULT COHORT AND BRINGING THE
ABCD COHORT AND A GROUP TO LOOK
AT THE MISC AND POST-VACCINATION
MENSTRUAL CYCLE CONDITIONS.
THE ENROLLMENT IS OPEN AND
PEOPLE CAN PLUG IN THEIR ZIP
CODE AND FIND THE CLOSEST SITE
TO THEM AND CONTACT THEM TO
ENROLL IN THE STUDY.
THE CHALLENGES ARE MOSTLY
RELATED TO THE NATURE OF THE
PANDEMIC.
ENROLLING PEOPLE IS NOT AS EASY
AS THE PAST.
LOTS OF PEOPLE JUST TAKE THE
TEST AT HOME AND DON'T TELL
ANYBODY.
THAT'S A HURDLE WE'RE PUSHING ON
TO GET THAT GROUP IN.
ENROLLING PEOPLE WHO HAVE
PERSISTENT SYMPTOMS IS QUITE
EASY AT THIS POINT AND SOME OF
THE SITES HAVE FILLED UP THE
QUOTA IN PEOPLE WHO HAVE
PERSISTENT SYMPTOMS.
OF COURSE, THE INFECTION'S
CHANGING AND THE VARIANTS ARE
CHANGE.
THERE'S VARIANTS THAT HAVE COULD
BE INCLUDED IN THE ANALYSIS.
THIS IS THE STUDY WE HAVE WITH P
CORENET WITH MORE THAN 60
MILLION RECORDS AND PUBLICATIONS
AROUND THE SYSTEM COMPLEX AND
CARDIAC COMPLICATIONS.
THIS TRIED TO DEVELOP THE RECORD
SIGNATURE OF LONG COVID AND WAS
ABLE TO USE DATA FROM PATIENTS
WHO GO FROM A POST-COVID
CLINICAL REFINING THAT
ELECTRONIC HEALTH RECORD
SIGNATURE.
PCORNET IS DISTRIBUTED IN
MULTIPLE ACADEMIC AND HEALTH
CARE SYSTEMS ACROSS THE COUNTRY.
THIS IS A MENTION OF
PATHOBIOLOGY.
WE HAVE A CALL OUT AND WE'RE
ALMOST AT THE END OF REVIEWING
AND FUNDING A NUMBER OF REALLY
GOOD APPLICATIONS FOR PEOPLE WHO
UNDERSTAND THE CLINICAL
MANIFESTATIONS OF PASC AND THIS
TAKES ADVANTAGE OF PATIENTS
ENROLLED AND THIS IS A
SUPPLEMENT TO PEOPLE IN GRANTS
THAT CAN DO RESEARCH THAT IS
RELEVANT AND IMPORTANT TO
UNDERSTANDING THE BIOLOGICAL
MECHANISMS OF PASC.
THIS IS WIDE OPEN COMPETITION
AND AGAIN SOME GOOD IDEAS COMING
IN.
SOME PEOPLE HAVE INTERESTING
PRELIMINARY DATA AS WELL.
LOOKING AT THE BEST WAY TO TREAT
THE COUGH OR PAIN OR
BREATHLESSNESS.
WE'D LIKE TO GET AT THE
UNDERLYING BIOLOGICAL DISEASE
MECHANISMS AND TREATMENT IN THAT
SPACE.
ANTIVIRALS FOR IMMUNE SYSTEM
MODULATORS.
THAT'S GOT TO BE PRETTY MUCH
DRIVEN BY WHAT WE UNDERSTAND
ABOUT THE BIOLOGY ON THAT SIDE
AND WE REACHED OUT TO A WIDE
COMMUNITY.
WE'VE DONE A LANDSCAPE ANALYSIS
OF WHAT'S GOING ON NOW.
THERE'S NOT A LARGE
SCIENTIFICALLY IT'S A LITTLE
WIDE OPEN AREA.
WE HAVE A CALL AND APPLICATIONS
ARE BEING FINALIZED FOR A
CLINICAL TRIAL DATA CENTER AND
PARTICULAR GRANTS IN TRIALS IN
THOSE OVER 18 YEARS OLD FOR THE
TREATMENT OF OR PREVENTION OF
PASC.
THERE'S AN OPPORTUNITY AND LOT
OF PEOPLE ARE SUFFERING AND LOTS
OF FRUSTRATION BECAUSE WE DON'T
KNOW MUCH ABOUT THE CONDITIONS
AND HOW IT TREAT THEM AND CAUSES
FRUSTRATION.
YOU CAN'T TELL PEOPLE HOW LONG
IT'S GOING TO LAST.
AND WE'RE LEARNING MORE ABOUT
THIS AND FOCUS ON THE TREATMENTS
AND WE HAVE THIS UNIQUE
OPPORTUNITY NOW TO UNDERSTAND
RECOVERY AFTER COVID AND SEE IF
THAT'S SOMETHING THAT CAN
POTENTIALLY BE ALTERED IN THE
ACUTE STAGES TO PREVENT PEOPLE
FROM DEVELOPING PASC.
THAT'S A TIME SENSITIVE
OPPORTUNITY.
I WANT TO THANK AMY PATTERSON
AND GARY GIBBONS AND YOU CAN'T
BELIEVE WHAT A BIG LIFT IT'S
BEEN.
WE THINK IT'S THE RIGHT THING TO
DO SO FOUR YEARS FROM NOW IF WE
DON'T FIGURE IT OUT, IT WON'T BE
BECAUSE WE DIDN'T TRY EVERYTHING
WE CAN THINK OF BUT WE HOPE WE
CAN FIGURE IT OUT AND MAKE A
DIFFERENCE FOR PEOPLE.
THE SOONER THE BETTER.
THANKS.
>> THANKS, WALTER.
>> THANK YOU, DR. KOROSHETZ AND
RECOVER TEAM FOR YOUR EFFORTS.
I WAS CURIOUS ABOUT THE GREATER
INCIDENTS OF POST-COVID SYMPTOMS
IN WOMEN AND IN PARALLEL THEY'RE
REDUCED HOSPITALIZATION FOR
THOSE SYSTEMS AND WHETHER
THERE'S AN AGE DISTRIBUTION
WHERE SPECIFIC AGE GROUP IS MORE
AFFECT
AFFECTED WHETHER THERE'S A
DISTRIBUTION ACROSS THE CHRONIC
SPACE OR SYMPTOMS.
I KNOW YOU'RE LOOKING AT THIS
BUT WHETHER THERE'S TEASERS.
>> NOT A LOT OF RIGHT NOW.
AND CLINICS GOT SET UP TO HELP
PEOPLE OUT OF ICUs.
THE BIG SURPRISE WAS THEY FILLED
UP WITH PEOPLE WHO WERE NEVER
EVEN IN THE HOSPITAL.
THAT WAS A SURPRISE.
IN THAT GROUP THERE'S A
PREDOMINANCE OF WOMEN.
AND IN THE STUDIES WE DO BY
IMMUNE SYSTEM AND NEURAL
FUNCTION WOMEN AND MEN ACT
DIFFERENTLY.
THERE'S CERTAIN CONDITIONS,
HEADACHE, THAT IS A COMMON
PROBLEM IN POST-COVID AND MORE
HIGHLY PREVALENT IN WOMEN THAN
MEN.
THE AUTOIMMUNE DISORDER IS MORE
PREVALENT IN WOMEN THAN MEN AND
THERE MAY BE INCLUDE IN THE SEX
GENDER DIFFERENCE WE NEED TO
FOLLOW-UP ON.
IN TERMS OF THE AGE GROUP THAT
SEEMS TO BE MOST PREDOMINANT IS
MID AGE, 35 TO 55.
>> THANK YOU.
>> I'M ASSUMING THIS IS ALL
DOMESTIC, U.S. BASED.
IS THAT THE CASE, THE CLINICAL
COMPONENT.
I'M WONDERING WHETHER THERE'S
OBVIOUSLY COVID IS EVERYWHERE.
IT SEEMS WE KNOW VERY LITTLE
ABOUT THE POST-ACUTE SYNDROME OR
COVID PARTICULARLY IN LOW AND
MIDDLE INCOME COUNTRIES IN
PARTICULAR.
>> THE W.H.O. IS SETTING UP TO
BE ABLE TO ANSWERS TO THE
QUESTION YOU ASKED AND THE
DEVELOPING SURVEYS TO BE USED IN
UNDER DEVELOPED COUNTRIES TO
ASSESS INCIDENTS OF THE
POST-COVID SYNDROME.
THAT ARE LOOKING AT THE BEST
OUTCOME MEASURES TO MEASURE THE
BURDEN OF ILLNESS DUE TO COVID.
>> AND THINKING CLINICAL TRIALS
AS WELL.
>> YES.
>> STEP ONE COLLECT THE DATA,
TWO, ANALYZE THE DATA.
I'M WONDERING WHERE THE THINKING
IS ON PREPARING THE KNOWLEDGE
ENVIRONMENT AND RESEARCH
PLATFORM, WHATEVER YOU WANT TO
CALL IT TO TAKE THE EXISTING
DATA AND ALSO THE INCOMING DET
AND THIS IS NOT JUST A
TECHNOLOGY QUESTION BUT POLICY
AND WHO AND HOW AND ALL THOSE
DIFFERENT THINGS.
>> OUR GOAL IS TO BRING THE DATA
TOGETHER TO MAKE IT ACCESSIBLE.
CORONET IS FEDERATED TO DO
QUERIES.
IN OUR DATA GROUP RIGHT NOW WE
HAVE A REGULAR SET OF QUERIES WE
ARE SENDING TO THEM AND GETTING
FEEDBACK ON A REGULAR BASIS AND
THE PLAN WOULD BE TO OPEN THAT
UP FOR THE WORLD.
>> WHAT ABOUT THE NEW DATA TYPES
YOU'LL BE COLLECTING.
IT TAKES LEAD TIME FOR THE
COHORT DATA AND CORO NET HAD A
FEDERATED MODEL.
>> THERE'S A DATA COORDINATING
CENTER FOR ALL THE DATA COMING
IN FROM ALL THE COHORTS AT THIS
POINT.
LINK TO THE BIO SAPECIMENS AND
IMAGING AND HOPEFULLY ELECTRONIC
HEALTH RECORDS.
I THINK THAT WOULD BE GOOD WAY
OF GOLD STANDARD WAY OF
DEVELOPING NEW SIGNATURES FOR
THE ELECTRONIC HEALTH RECORD
SEARCHS.
PORTAL IS BEING BUILT BY THE
DATA CENTER.
WE WANT THAT OPEN IN THE SENSE
THAT REPUTABLE INVESTIGATORS
WILL GET TO THE DATA.
AND MAYO CLINICAL AND THOSE ALSO
SUING YOU HAVE THESE PEOPLE WHO
WRITE A PAPER SAYING THEY FOUND
X, Y AND Z.
WE SHOULD BE ABLE TO GO TO THE
SAMPLE COLLECTIONS AND VALIDATE
IT IN OUR GROUP AS WELL.
THE GOAL IS TO OPEN THIS UP.
>> GREAT, THANK YOU, WALTER.
I KNOW THERE'S MORE
CONVERSATIONS WITH THE "ALL OF
US" DATA DATA TEAM MAY BE ABLE
TO ASSIST OR CORRELATE OR STAND
ON EACH OTHER'S SHOULDERS, HAPPY
TO MOVE THAT FORWARD.
>> BE CAREFUL WHAT YOU ASK FOR.
>> THERE'S ACADEMIC CENTERS.
WHAT ABOUT COMMUNITY CENTERS,
V.A., FEDERALLY QUALIFIED HEALTH
CENTERS.
TAKING INTO ACCOUNT TO WHAT
LARRY TABAK SAID EARLIER NOT THE
USUAL CENTERS GETTING THE
FUNDING LIKE WITH COVID AND
REACH THE COMMUNITY BEYOND THE
MEDICAL CENTERS.
>> BEYOND THE ELECTRONIC HEALTH
RECORD, I THINK I HAVE TO TAKE
THAT BACK AND SEE WHAT THE
POSSIBILITIES ARE THERE.
THAT'S A GREAT IDEA.
THE V.A. HAS BEEN VERY
AGGRESSIVE AND PUBLISHED HEAVILY
ALREADY ON THE ELECTRONIC HEALTH
RECORD DATA IN VETERANS WHO
DEVELOPED COVID.
SOME OF THE BEST DATA'S COME
FROM THE V.A.
>> CAN YOU TAKE STEPS TO
INCREASE PATIENT ENGAGEMENT
SINCE THE LAST ACD MEETING.
>> WE HAVE DEVELOPED A STEER
COMMITTEE AND PATIENT COMMITTEES
WITH ENGAGEMENT ON THEM AT THE
DIFFERENT SITES.
WE HAVE PATIENTS THAT PATIENTS
THAT HAVE BEEN INTEGRATE INTO
THE STUDIES AT THE SITES AND
HUBS AND CONTINUE TO HAVE
SESSIONS WHERE WE GET INPUT FROM
FOLKS.
>> WE HAVE THE EXECUTIVE
COMMITTEE AND STEERING COMMITTEE
AND 12 PATHOBIOLOGY TASK FORCES
AND SIX OVERSIGHT COMMITTEES.
>> PART OF THE CHALLENGE HAS
BEEN FOR PEOPLE SUFFERING FROM
LONG COVID WANT TO KNOW WHAT CAN
YOU DO FOR ME NOW.
THERE'S AN IMMEDIATE PRACTICAL
REQUEST WHAT CAN YOU DO FOR ME
NOW?
DON'T TELL ME ABOUT YOUR STUDIES
OR HOW HARD IT IS, TELL ME WHAT
YOU CAN DO FOR ME NOW.
THERE'S NOTHING SURPRISING HERE.
IF YOU LOOK AT THE APPROACHES
THAT WORKED FOR THE ACUTE
DISEASE COULD SOME POTENTIALLY
WORK FOR THE LONG COVID.
THE OTHER IS BALANCING WHO YOU
ENROLL.
IF YOU'RE NOT CAREFUL AND I KNOW
THE TEAM IS ATTUNE TO THIS,
YOU'LL WIND UP WITH
OVERWHELMINGLY WHITE FEMALE
POPULATION.
YOU ALSO WANT TO UNDERSTAND HOW
THIS IS ADVERSELY AFFECTING
OTHER MEMBERS OF THE COMMUNITY.
SOME PEOPLE MAKE THE INQUIRY,
I'M NOT BEING ENROLLED AND PART
IS BECAUSE THE NEED TO BALANCE
THINGS UP.
THERE'S SUGGESTIONS IN THE CHAT
BOX ENGAGING WITH PHARMACIES AND
THE WALGREENS OF THE WORLD AND
ALL OF THIS HAVE DONE THIS
PRETTY EFFECTIVELY.
THERE MAY BE LESSONS LEARNED
THERE AS WELL.
>> THOUSANDS OF PEOPLE ARE
AFFECTED AND THEY'RE TRYING
DIFFERENT WAYS OF TREATING
PEOPLE TO TEST SOME THINGS MAYBE
BRING BEST PRACTICES OUT SEEMS
LIKE A LOGICAL STEP WE CAN DO
NOW AND SO I THINK THAT WOULD BE
THE FIRST START.
THE LATER IT WILL BE HARDER TO
GET PEOPLE TO THAT HIGHER
FUNCTIONAL LEVEL.
>> ANY LAST QUESTION FOR WALTER?
>> RECOVERCOVID.org.
TELL EVERYBODY TO SIGN UP IF YOU
GET INFECTED.
HOPEFULLY YOU DON'T.
>> WE HAVE DIANA ON AND WE'RE
EARLY SO HOPEFULLY WE CAN START
THE BREAK EARLIER.
>> I'M COMING TO EVERYONE THE
WESTIN IN LONG BEACH, CALIFORNIA
THE RESEARCH SOCIETY MEETINGS
ARE GOING ON HERE AND NIH HAS A
BIG PRESENCE DUE TO THE $70
MILLION INVESTMENT.
IT'S VERY EXCITING.
I APOLOGIZE.
I HAVEN'T HEARD WALTER'S
PRESENTATION BUT HOPEFULLY
TECHNICALLY EVERYTHING IS
WORKING WELL.
I'LL TALK ABOUT THINGS THAT
DON'T GET A LOT OF ATTENTION IN
TERMS OF THE AFFECTS OF COVID-19
ON DIFFERENT BODY SYSTEMS.
WE DON'T WANT TO FORGET THEM
BECAUSE THEY'RE IMPORTANT.
I'LL BE TALKING ABOUT COVID-19
EFFECTS ON FEMALE AND MALE
REPRODUCTIVE SYMPTOMS AND TALK
ABOUT COVID-19 VACCINATION AND
PREGNANCY AND LACTATION AND
WE'VE MADE SIGNIFICANT PROGRESS
AND I WANTED YOU TO KNOW AND
WILL END ON THREE FUTURE
CHALLENGES.
THERE'S BEEN A LOT OF ANECDOTAL
REPORTS ON CHANGES TO MENSTRUAL
CYCLES AMPLIFIED ON SOCIAL MEDIA
AND BACK IN APRIL THE TITLE OF
AN ARTICLE WAS NO, WE DON'T FLOW
IF VACCINES CHANGE YOUR PERIOD.
I CAN SAY THE ANSWER IS YES NOW
DUE TO NIH FUNDED RESEARCH.
WOMEN WERE CONSISTENTLY
REPORTING CHANGES TO THE TIMES
OF MENSTRUAL CYCLES.
THE FACT THEY SKIPPED PERIODS.
WOMEN WHO HAD UNDER GONE
MENOPAUSE NOW BLEEDING AND
BETWEEN CYCLES AND CHANGES IN
MENSTRUAL FLOW AND COMORBIDITIES
SUCH AS INCREASED PAIN DURING
MENSTRUAL CYCLES.
WE DIDN'T KNOW ABOUT VACCINES
AND HOW THEY AFFECTED PERIODS
BECAUSE DATA ON MENSTRUAL
CHANGES ARE NOT ROUTINELY
COLLECTED DURING VACCINE SAFETY
TRIALS.
IT'S NOT UNIQUE TO THE SARS COV2
VACCINES IT'S NOT GENERALLY
COLLECTED AND WE WOULD ARGUE IT
NEEDS TO BE COLLECTED.
WE RECOGNIZE THERE WAS A GAP IN
THE DATA.
THIS IS SOMETHING WE CHECKED IN
WITH NIAID AND WERE NOT LOOKING
AT AND ALIGNED WITH OUR
INTERESTS BECAUSE WE ARE
CURRENTLY FUNDING INVESTIGATORS
STUDYING THE MENSTRUAL CYCLES
FOR A VARIETY OF REASONS.
THE STAFF AT THE HEALTH AND
DISEASE BRANCH AWARDED $1.6
MILLION TO FIVE DIFFERENT
INSTITUTIONS LAST SUMMER.
THERE WERE OVER 15,000 WOMEN
THEY WERE TRACKING WHO WERE
QUITE DIVERSE BOTH
GEOGRAPHICALLY AND RACIALLY AND
ETHNICALLY AND THEY WERE LOOKING
AT HOW CONFOUNDERS LIKE STRESS
AND INFORMATION BIAS AFFECT THE
MENSTRUAL CYCLE.
WE'VE ALL BEEN THROUGH STRESSFUL
TIMES SO IT COULD BE IT'S STRESS
AFFECTING THE MENSTRUAL CYCLE
AND NOT THE VACCINES AT ALL.
THEY WERE BEING STARTED BY
DR. PAIN AT HARVARD COLLECTING
SALIVA FOR VARIOUS HORMONE
STUDIES.
WE ALSO HAVE A NUMBER OF
REQUESTS WHO ARE USING MENSTRUAL
TRACKING AND LOOKING AT VARIOUS
WAYS TO QUANTIFY MENSTRUAL FLOW.
THIS MICHIGAN STATE STATE
TRACKING WOMEN FOR MANY YEARS
WITH A PARTICULAR EMPHASIS ON
ENDOMETRIOSIS ASSOCIATED WITH
EXTREME PAIN.
AND OREGON UNIVERSITY WAS ABLE
TO COME UP WITH RESULTS QUICKLY
AND THEY'RE USING A NUMBER OF
DIFFERENT FERTILITY AWARENESS
APPS ON THE SMARTPHONE TO TRACK
MENSTRUAL CYCLES.
FINDINGS SHOW IF YOU GOT ONE
DOSE OF MODERNA OR PFIZER IT
LENGTHENED THE INTERVAL OF
MENSTRUATION BY ONE DAY AND IF
YOU GOT THE PFIZER VACCINE IN
THE SAME CYCLE LENGENED BY TWO
DAYS.
THE INTERVAL WAS LENGTHENED BUT
NOT THE NUMBER OF MENSES WERE
BLEEDING AND ONLY LASTED FOR THE
CYCLE FOLLOWING THE VACCINATION.
THE NEXT CYCLE RETURNED TO
NORMAL AND SUBSEQUENT CYCLES.
IMPORTANTLY THIS MINIMAL
INCREASE IN LENGTH IS NOT
CONSIDERED SIGNIFICANT AND
THERE'S A CYCLE LENGTH AS NORMAL
IF IT'S LESS THAN TWO DAYS.
WE SHOULD FIND OUT THE STUDY
RECEIVED ENORMOUS ATTENTION AND
ON SOCIAL MEDIA AND THE LAY
MEDIA AND WE WERE DULU DELUGED
WOMEN WOULD WANTED TO SHARE
THEIR EXPERIENCE AND WE WERE
TOLD THE DATA PROVIDED
REASSURANCE THAT VACCINATION
DOES NOT AFFECT THE MENSTRUAL
CYCLE.
THIS IS FOLLOWED BY ANOTHER
PRELIMINARY STUDY SHOWING NO
EFFECTS ON FERTILITY WHICH IS
ANOTHER AREA WHERE THERE'S BEEN
A TREMENDOUS AMOUNT OF
MISINFORMATION.
THERE'S A PORTFOLIO FOR THE MALE
REPRODUCTIVE SYSTEM AND WE'VE
BEEN INTERESTED HOW COVID-19
INFECTION AND COVID-19
VACCINATION AFFECT MALE
FERTILITY AS WELL.
THERE'S NO EVIDENCE THAT
VACCINATION AFFECTS FERTILITY
FROM THE MALE BUT WE HAVE SOME
DATA THAT SUGGEST COVID-19
INFECTION CAN TEMPORARILY REDUCE
MALE FERTILITY.
BY ONE STUDY OF INVESTIGATORS IT
WAS SHOWN THERE WAS AN 18% LOWER
CHANCE OF CONCEPTION IF THE MALE
PARTNER WAS INFECTED WITHIN 60
DAYS BEFORE THE MENSTRUAL CYCLE
THAT RESULTED IN CONCEPTION OF A
CHILD.
OVER ALL IF YOU LOOKED OVER THE
COURSE OF THE YEAR IF YOU WERE
INFECTED WITH SARS COV2 THERE
WASN'T A LONG EFFECT THIS
SUGGESTS A TEMPORARY EFFECT OF
EITHER VACCINATION OR
VACCINATION IN THE FEMALE OR
INFECTION ON THE MALE UPON
FERTILITY.
THE NEW YORK TIMES INTERESTING
AND THOUGHT-PROVOKING ARTICLE
CAN COVID LEAD TO IMPOTENCE.
WE DON'T KNOW THE ANSWER AND I
SEE WALTER STILL ON SO I CAN
PERHAPS ASK HIM TO WEIGH IN
AFTER I'M DONE WHETHER WE'RE
COLLECTING INFORMATION ON ANY
SEXUAL DYSFUNCTION OR PROBLEMS
WITH ERECTILE DYSFUNCTION IN MEN
BECAUSE IT'S BEEN SUGGESTED
CORONAVIRUS CAN INFECT THE MALE
GEN GENITAL TRACT AND THEY'RE
SEEING AFFECT IN YOUNGER MEN.
GOING BACK TO VACCINATION IN THE
FEMALE POPULATION, WE'VE BEEN
INTERESTED IN ASSURE VACCINATION
IS SAFE PARTICULARLY WHILE
PREGNANT OR BREAST FEEDING WE
FUNDED A NUMBER OF STUDIES THAT
HAVE LOOKED AT HOW VACCINATION
AFFECTS ANTIBODY LEVELS.
FOR EXAMPLE IN THE FIRST BULLET
THE ANTIBODY LEVELS ARE HIGHER
IN WOMEN POST VACCINATION
PREGNANT VERSUS NATURAL
INFECTION DURING PREGNANCY.
FURTHERMORE THE VACCINE-INDUCED
ANTIBODIES ARE PRESENT IN BREAST
MILK SAMPLES.
I ALWAYS LIKE TO TELL PEOPLE YOU
ARE CONCERNED ABOUT YOUR BABY
WHO IS UNDER OF 6 MONTHS EVEN IF
THE VACCINES ARE APPROVED THE
BEST PROTECTION FOR THE BABY IS
TO GET VACCINATED WHILE PREGNANT
AND BREAST FEED THE BABY BECAUSE
THE VACCINE INDUCED ANTIBODIES
ARE TRANSFERRED TO BREAST MILK
AND THERE'S CONCERN ABOUT THE
TIMING WHEN IS BEST.
IF YOU'VE NEVER BEEN VACCINATED
IT'S PROBABLY BEST TO GET
VACCINATED IN THE FIRST
TRIMESTER OF PREGNANCY.
THERE ARE POTENTIAL MATERNAL AND
FETAL BENEFITS WITH REDUCTION OF
INFLAMMATION IN THE PLACENTA AND
WOMB AND WHAT THE FETUS IS
EXPOSED TO.
HOWEVER, IF YOU HAVE BEEN
VACCINATED IT WILL BE HELPFUL TO
HAVE A BOOSTER IN THE THIRD
TRIMESTER.
THERE'S BEEN NO EVIDENCE
VACCINES CAUSE ANY COMPLICATIONS
IN PREGNANT PEOPLE BUT THAT'S
THERE'S BEEN CONCERN 300
PREGNANT WOMEN HAVE DIED AND
PROBABLY NEEDLESSLY BECAUSE THEY
WERE UNVACCINATED.
THERE'S PROTECTION AGAINST
HOSPITALIZATION IF THE MOTHER
HAD BEEN VACCINATED.
THE INFANTS WERE HOSPITALIZED
LARGELY BECAUSE THE MOTHERS WERE
NOT VACCINATED DURING PREGNANCY.
MISC IS MULTI-SYSTEM
INFLAMMATORY SYNDROME IN
CHILDREN WITH LABORATORY
DIAGNOSTICS AND ARTIFICIAL
INTELLIGENCE.
AND THIS PROGRAM WAS FUNDED
THROUGH THE RADX RADICAL
INITIATIVE LOOKING TO PREDICT
WHICH CHILDREN WILL DEVELOP MISC
NOW INCLUDED IN THE UMBRELLA OF
CONDITIONS THAT ARE KNOWN AS
LONG COVID.
MISC IS ONE OF THE PEDIATRIC
FORMS OF LONG COVID.
[TECHNICAL DIFFICULTIES]
AND THERE'S THE NIH THE SMALL
BUSINESS EDUCATION AND
ENTREPRENEURIAL PROGRAM FUNDED
BY THE NIH OFFICE OF THE
DIRECTOR AND EXTRAMURAL
RESEARCH.
AS A FORMER ACADEMIC, I REALLY
KNEW NOTHING ABOUT TRANSLATING
FINDINGS TO A BUSINESS PLAN AND
THAT'S THE GOAL OF THIS TO TAKE
INNOVATION AND THE NIH
INVESTIGATORS WHO ARE INNOVATING
AND GIVE THEM RESOURCES TO BOTH
VALIDATE AND ADVANCE THEIR
DISCOVERIES TO TRANSLATE TO
PATIENT CARE.
I WANT TO DEVELOP RELATIONSHIPS
WITH STRATEGIC PARTNERS AND
BUILD OPPORTUNITIES FOR THEM TO
FURTHER THEIR PROGRESS
DEVELOPMENT EFFORTS.
IT ALLOWS THEM TO APPLY FOR
EMERGENCY USE AUTHORIZATION,
WHICH IN TURN ALLOWS PRODUCTS TO
MOVE MORE QUICKLY TO
TRANSLATION.
SOME ARE MOVING TOWARDS FDA EUA
APPROVAL.
THE FIRST IS AT THE UNIVERSITY
OF CALIFORNIA SAN DIEGO FROM
JANE BURNS.
HER TEAM IS USING RNA PROTEIN
ANTIBODY AND CLINICAL PARAMETERS
TO PREDICT REGRESSION TO SEVERE
COVID AND MIS-C.
THEY TOOK ADVANTAGE OF A LONG
ONGOING COLLABORATION WITH THE
U.K. AND REMEMBER IT WAS FIRST
RECOGNIZED IN THE U.K.
IT WAS A HEAD START THERE.
AS WELL AS A U.S. COHORT AND
THERE'S CARE TO DISTINGUISH
BETWEEN MIS-C OR RELATED
PEDIATRIC CONDITION KNOWN AS
KAWASAKI DISEASE AND OTHER
ILLNESSES.
AND THIS ALGORITHM IS BEING
REVIEWED BY THE FDA.
IN THE MEANTIME, THEY ARE
EXPANDING THEIR PREDICTED
ALGORITHM WORK BY VALIDATING
ACUTE PCR ASSAY THAT PREVIOUSLY
IDENTIFIED THE SIGNATURE FOR
MIS-C AND ARE USING THE PROTEINS
THAT CAN IDENTIFY MIS-C
BILATERAL FLOW USING
TECHNOLOGIES LIKE SOMAMERS AND
ELISA.
THERE'S RESPONSE DIFFERENCES
BETWEEN KAWASAKI DISEASE WHICH
HAS SIMILAR FINDING TO MIS-C.
PROBABLY MIS-C HAS MORE
PATHOLOGY SYSTEM AND MORE SEVERE
CARDIAC PATHOLOGY IN TERMS OF
HYPERTENSION AND THE NEED FOR
REPRESSERS.
THEY DID THEIR INITIAL STUDY
BASED ON PUBLICLY AVAILABLE
KAWASAKI DISEASE DATA SETS AND
RECRUITED COHORTS.
MANY INVESTIGATORS ARE USING
CHILDREN PRESENTING TO THE
EMERGENCY ROOM AS THEIR
CONTROLS.
IN MIS-C AND OTHERS THERE WERE
UPREGULATION OF INTERLEUKIN 15
AND PATHWAYS.
THEY SHOWED MANY SIMILAR
MOLECULAR MARKERS IN KAWASAKI
DISEASE AND MIS-C BUT THE
HYPERINFLAMMATORY RESPONSE WAS
HIGHER IN MIS-C.
THEY'VE IDENTIFIED SOME OF THE
PATHWAYS.
THIS IS LINKED DIRECTLY TO
MECHANISM TREATMENT-BASED
RECOMMENDATIONS TO TREAT WITH
ANAKINRR AND INFLIXIMAB.
I WANTED TO HIGHLIGHT THE BAYLOR
COLLEGE OF MEDICINE THEY'RE
USING AN A.I. APPROACH TO LOOK
AT RISK ASSESSMENT FOR COVID-19.
THEY LOOKED AT A RANGE OF
MARKERS.
THEY HAD A 50,000 PARTICIPANT
COHORT, HIGHLY DIVERSE AROUND
TEXAS.
KIDS WITH COVID-19 AND THEN SOME
OF THEM HAD KNOWN MIS-C AND THEY
ENROLLED 400 PARTICIPANTS.
THE WHOLE PURPOSE WAS TO PREDICT
WHO WOULD BE AT RISK FOR MIS-C.
IF YOU LOOK AT THE IMAGE IN THE
UPPER RIGHT THERE'S PALE PINK
DOTS.
THOSE ARE COVID-19 KIDS WHO WERE
IN THE TRAINING SET.
THE DARK RED IS ACTUALLY KNOWN
AND VALIDATED MIS-C CASES.
DARK PINK IS THE TRAINING MIS-C
AND GRAYISH BLUE ON THE LEFT IS
THE COVID-19 IN THE TRAINING
SET.
YOU CAN SEE THAT THEIR ALGORITHM
SEPARATES BOTH ON THE TRAINING
SET AND VALIDATION SET.
THE MIS-C CASES WHICH ARE IN
DARK RED.
THEY'RE PREPARING AN EUA PACKAGE
BASED ON THEIR MARKERS WHICH ARE
NOT GENES BUT INFLAMMATORY
CHEMOKINES AND SIGCYTOKINES AND
LOOKING AT MET -- MEDICAL
RECORD AND CHEST X-RAY DATA.
THEY WERE ABLE TO HIGHLIGHT THE
IMPACT ON SOCIO ECONOMIC AND
RACE WITH DISEASE SEVERITY.
THEY ON THE BASIS OF THEIR
STUDIES WERE ABLE TO SHOW
NON-HISPANIC BLACK CHILDREN AND
CHILDREN IN HIGH DEPRIVATION
INDEX AREAS WERE MORE LIKELY TO
REQUIRE SUPPORT.
WE'RE PROUD OF THIS BECAUSE IT'S
BEEN IN A LITTLE OVER UNDER A
YEAR.
TREMENDOUS PROGRESS MADE.
I'M HOPING TO HAVE TIME FOR
QUESTIONS BUT WANT HIGHLIGHT
THREE FUTURE CHALLENGE.
THE FIRST IS VACCINATION.
NEXT WEEK DATA IS TO BE REVIEWED
FROM MODERNA AND PFIZER FOR
CHILDREN 6 MONTHS TO 5 YEARS WHO
HAVE NOT BEEN VACCINATED AND
THEY'RE PASSING THE VIRUS ALONG
THOUGH NOT SYMPTOMATIC.
THE CHALLENGE IS WHEN THE
VACCINE IS APPROVED.
RELATIVELY FEW CHILDREN ARE
GETTING THE VACCINE AND IT'S NOT
A MATTER OF ACCESS.
I HAPPENED TO BE IN NEW YORK
CITY LAST WEEKEND AND PLEASANTLY
SURPRISED EVERY FEW BLOCKS YOU
HAVE MOBILE VANS THAT PROVIDE
VACCINATION TO PEOPLE OF ALL
AGES.
AT LEAST IN NEW YORK CITY YOU
CAN WALK DOWN THE BLOCK AND YOU
CAN GET VACCINATED.
THIS IS EXTREMELY TROUBLING
BECAUSE WE HAVE THE VACCINES.
THEY ARE SAFE AND NOT 100%
EFFECTIVE BUT EFFECTIVE IN
REDUCING DISEASE AND CERTAINLY
HOSPITALIZATION.
IT'S A LITTLE BIT BETTER FOR
ADOLES
ADOLESCENTS.
STILL IT'S TROUBLING ONLY 58% OF
TEENAGERS ARE FULLY VACCINATED.
I'M HIGHLIGHTING THIS AS OUR
FIRST CHALLENGE AND WE ALL NEED
TO DO MORE TO ENCOURAGE
VACCINATION IN THE PEDIATRIC
POPULATION.
WE KNOW FROM PAST PANDEMICS THE
POTENTIAL FOR NEURODEVELOPMENT
CONSEQUENCES IN SUBSEQUENT
GENERATION.
WHAT WE KNOW SO FAR IS IT ISN'T
SEEM LIKE THERE'S A WHOLE LOT OF
TRANSMISSION OF THE VIRUS ACROSS
THE PLACENTA.
WE KNOW IT DEVELOPS IN A MOTHER
WHO HAS SYSTEMIC INFLAMMATION
CAN BE CONCERN AND THERE ARE
PRELIMINARY REPORTS SUGGESTING A
CONNECTION BETWEEN PRENATAL SARS
COV2 AND DEVELOPMENT DISORDERS
IN OFFSPRING.
WE NEED TO STUDY THIS MORE.
WE WOULD SUGGEST CELLULAR MODELS
OF FETAL BRAIN DEVELOPMENT COULD
HELP UNDERSTAND THE POTENTIAL
SHORT AND LONG-TERM IMPACTS OF
MATERNAL SARS COV2 INFECTION ON
OFFSPRING AND PARTICULARLY THE
LONG-TERM EFFECTS.
WE DON'T KNOW THE DIFFERENCES
AND IF THERE'S A VULNERABLE
WINDOW FOR THE FETUS AND CHILD.
THERE'S A PLEA TO INCLUDE
PREGNANT AND LACTATING PEOPLE IN
RESEARCH.
THE 21st CENTURY CURES ACT
SIGNED BY PRESIDENT OBAMA IN
DECEMBER 2016 MANDATE THE ED THE
FORMATION OF A TASK FORCE
SPECIFIC TO PREGNANT AND
LACTATING WOMEN KNOWN AS PRGLAC.
THEY MET REGULARLY BETWEEN 2017
AND 2020 WITH REPRESENTATION
FROM MULTIPLE NIH INSTITUTES AND
CENTERS AND OFFICES OTHER
FEDERAL PARTNERS AND INDUSTRY
AND ACADEMIA AND ADVOCACY
GROUPS.
WE ISSUED RECOMMENDATIONS TO THE
SECRETARY AND IN ADDITION TO
DEVELOP PRACTICAL AND FEASIBLE
IMPLEMENTATION PLAN.
OUR MANTRA WAS TO CHANGE THE
CULTURE TO PROTECT PREGNANT
PEOPLE THROUGH RESEARCH INSTEAD
OF FROM RESEARCH.
AS WE WROTE IN JAMA THE
IMPLEMENTATION PLAN WE HOPED
WOULD GUIDE PEOPLE IN A
SITUATION SUCH AS THIS WERE
REALLY NOT RECOGNIZED AS A
PUBLIC HEALTH EMERGENCY.
I'M NOT SAYING ANYTHING COULD
HAVE BEEN DONE DIFFERENTLY BUT
WHAT I AM SAYING IS WE NEED TO
PLAN FOR THE INCLUSION OF
PREGNANT AND LACTATING PEOPLE
FOR THE NEXT PANDEMIC TO BE ABLE
TO EVALUATE AND WE SAW WHAT
HAPPENED HERE WAS THERE WAS A
VERY MIXED MESSAGING.
PREGNANT PEOPLE WERE CLEARLY
GETTING SICKER THAN NON-PREGNANT
PEOPLE WITH COVID-19 AND
YESTERDAY WE DIDN'T HAVE
EVIDENCE TO REASSURE PEOPLE
ABOUT THE SAFETY OF GETTING THE
VACCINE AND ULTIMATELY WE RELIED
ON INFORMATION THAT WAS
VOLUNTARILY REPORTED BY PREGNANT
PEOPLE TO THE VACCINE THAT WAS
MAINTAINED BY THE C.D.C.
THAT'S A CHALLENGE IS HOW TO
PREPARE FOR WHATEVER COMES NEXT
AND HOW IT WILL AFFECT PREGNANT
WOMEN AND THEIR FETUSES.
WITH THAT, THAT'S THEN OF MY
FORMAL PRESENTATION.
I KNOW IT'S HARD FOR ME TO
MULTITASK AND READ THE CHAT AT
THE SAME TIME.
>> I DON'T SEE SPECIFIC
QUESTIONS.
>> I HAVE ONE QUESTION.
>> GO AHEAD.
>> YOU PRESENTED SOME
INFORMATION IN TERMS OF
AFFECTING THE AVERAGE WOMAN'S
DECISION ON VACCINATION AND HOW
IT'S INVOLVED IN PUBLIC
DISCOURSE.
HOW PERCEIVE GETTING THE
INFORMATION OUT AS THE SCIENCE
IS DEVELOPING?
IT'S A CHALLENGE BECAUSE THE
SCIENCE IS DEVELOPING BUT IT'S
SO TIMELY AND THE NEW YORK TIMES
ARTICLE PEOPLE ARE MAKING
DECISIONS ABOUT LIFE.
AND THERE'S MECHANISMS TO DO
THAT.
>> THAT'S A GREAT QUESTION.
WE SEE OUR PRIMARY ROLE AS
FIGURING OUT AND THROUGH THE
LENS OF OUR POPULATIONS WHICH
ARE CHILDREN, PREGNANT PEOPLE,
PEOPLE OF REPRODUCTIVE AGE AND
PEOPLE WITH INTELLECTUAL AND
PHYSICAL DISABILITIES.
WITHIN THOSE POPULATIONS, WHERE
ARE THE EVIDENCE GAPS?
THE MENSTRUATION QUESTION WAS A
PERFECT EXAMPLE.
THERE WAS A HUGE GAP.
HUGE INTEREST ON THE PART OF THE
LAY PUBLIC.
WHAT COULD WE DO IN A SHORT TIME
FRAME.
GENERALLY IT'S SUPPLEMENTS IN
THAT CASE.
IF THERE'S A REAL NEED TO GET
INFORMATION OUT MONTHS TO YEARS
WE'RE TALKING ABOUT SUPPLEMENTS.
WE FUND THE STUDIES AND GET THE
EVIDENCE AND OUR OFFICE OF
COMMUNICATION WORKING WITH THE
NIH OFFICE OF COMMUNICATIONS
GOES TO WORK ON SPREADING THE
WORD AND THEY HAVE CLOSE
RELATIONSHIPS WITH THE ADVOCACY
GROUPS AND PROFESSIONAL
SOCIETIES.
THROUGHOUT THE PANDEMIC WE'VE
BEEN SPEAKING VERY REGULARLY
WITH THE AMERICAN ACADEMY OF
PEDIATRICS FOR EXAMPLE.
THE SOCIETY FOR WOMEN'S HEALTH
RESEARCH.
THE SOCIETY FOR MATERNAL FETAL
MEDICINE TO MAKE SURE THEY HAVE
THE EVIDENCE ON THE STUDIES AND
THEY ARE WORKING WITH US TO
PROMOTE THE INFORMATION.
>> TARA, IF I CAN JUMP IN FOR A
SECOND, WHILE I AGREE WITH
DIANA'S ASSESSMENT OF ONE WAY OF
GETTING THINGS DONE RAPIDLY IS
THROUGH SUPPLEMENTS, BECAUSE OF
THE 21st CENTURY CURES THE
ABILITY TO DO OTHER TRANSACTIONS
WHICH IN EFFECT ALLOWS TO YOU
BUILD YOUR TEAM DE NOVO AND DO
REVIEW NOT BY THE TRADITIONAL
PEER REVIEW SYSTEM BUT BY USING
FEDERAL WORKFORCE FOLKS.
THAT'S ANOTHER WAY WHICH NIH IS
INCREASINGLY TAKING ADVANTAGE
OF.
I DON'T KNOW IF WE CAN SAY IT'S
DARPA LIKE BUT IT'S ONE
MECHANISM.
YOU DIDN'T HAVE THE BENEFIT OF
HEARING EARLIER CONVERSATIONS.
THERE'S BEEN AAN ADMONISHMENT O
YOU DID THING QUICKLY FOR COVID,
CAN DO IT FOR OTHER THINGS.
WE HAVE OTHER TOOLS AND
TRANSACTIONS.
>> O.T.A. NOT EVERY INSTITUTE
HAS THEIR OWN O.T.A.
THERE'S SEVERAL INSTITUTES THE
OFFICE OF THE DIRECTOR DOES.
>> THANK YOU FOR A SUPERB
PRESENTATION.
VERY COMPREHENSIVE AND
INFORMATIVE.
WE HEAR ABOUT ADOLESCENCE AND
MENTAL HEALTH CRISIS AND IT'S
DOMINATING AND A GREAT CONCERN
IN TERMS OF YOUNGER AND OLDER
ADOLESCENCE.
I'M WONDERING WHAT THE PORTFOLIO
LOOKS LIKE IN TERMS OF RESEARCH
IN THAT AREA.
>> ACTUALLY NATIONAL MENTAL
HEALTH IS THE LEAD INSTITUTE FOR
ADOLESCENT MENTAL HEALTH ISSUES.
WE PARTNER WITH THEM ON A NUMBER
OF INITIATIVES.
IT'S SOMETHING WE'RE CONCERNED
ABOUT AS WITH VIOLENCE IN
SCHOOLS AND WE'RE ADDRESSING
THESE VERY IMPORTANT ISSUES.
THE THINGS CHILDREN HAVE
EXPERIENCE IN THE LAST TWO YEARS
ARE GOING TO RESONATE FOR MANY
YEARS.
>> SHELLY, YOUR QUESTION.
WE MIGHT WRAP UP.
WE'RE HEADING INTO THE BREAK.
>> THANK YOU.
I ENJOYED THAT.
I WANTED TO CONGRATULATE YOU ON
REPORTING ON THE NEGATIVE DATA
WHICH WE DON'T OFTEN HEAR AND
WAS GREAT TO HEAR THAT TO TRY TO
DISPEL MISINFORMATION ON OUR
MINDS SO MUCH NOW.
I REALLY LIKE THAT AT THE
BEGINNING.
THEN I HAD A QUESTION I THOUGHT
YOU SAID IF I CAUGHT IT RIGHT
WITH MIS-C I THOUGHT YOU SAID
THERE'S A FOUR-GENE SIGNATURE
COMING OUT IN THE SEQUENCING.
I WAS CURIOUS WHAT ARE THOSE
FOUR GENES, SUPER CURIOUS IS
THAT SEEN IN ADULT-LONG COVID
AND I ALSO WANTED TO SAY I
THOUGHT THE SUPPLEMENTS WERE
AMAZING THEY'RE ACCOMPLISHING
ALL THIS.
I KNOW YOU WANT TO BRING IN
OTHER PEOPLE BUT TRULY AMAZING.
>> THANK YOU.
THOSE PARTICULAR SUPPLEMENTS
WERE OKAY BECAUSE IT'S A
SPECIALIZED AREA.
>> YOU CAN TELL ME LATER OR PUT
THEM IN THE CHAT IF IT'S
INFLAMMATION OR OTHER THINGS
COMING UP.
>> I DON'T THINK THE SAME GENES
HAVE BEEN STUDIED IN ADULTS.
IT'S CHILDREN.
>> GOT IT.
THANK YOU.
>> LARRY, BACK TO YOU TO TAKE US
TO BREAK.
GREAT PRESENTATIONS, TONY,
WALTER AND DIANA.
HOPEFULLY IT GIVES A GREATER
FEEL FOR WHAT THE STATUS OF
COVID RELATED AND OTHER MORE
CHRONIC COVID-19 SEQUELAE.
WE'LL TAKE A SHORT BREAK NOW.
AS THOSE WHO ARE BEEN ON THE
COMMITTEE KNOW WE HAVE A SERIES
OF WORKING GROUPS THAT TACKLE
PARTICULARLY VEXING PROBLEMS.
WE GET PEOPLE FOR MEMBERSHIP ON
A COMMITTEE.
THE LUCKY INDIVIDUAL IN THIS
CASE WAS BARBARA WOLD AND A
ROBUST REPORT WAS CREATED UNDER
BARBARA'S LEADERSHIP.
WE HAVE DISCUSSED THE REPORT
THOROUGHLY IN PREVIOUS SESSIONS.
THIS WILL BE AN UPDATE ON SOME
OF THE IMPLEMENTATION EFFORTS.
AS YOU MIGHT IMAGINE FOR
SOMETHING AS BROAD AS THIS TOPIC
IT'S A TEAM SPORT AND SEVERAL
OFFICES WITHIN NIH ARE ENGAGED.
YOU THE OFFICE OF EXTRAMURAL
RESEARCH HAS TAKEN THE LEAD.
>> AS MENTIONED THIS IS AN
UPDATE ON WHAT HAS COME OUT OF
THE WORK THAT WAS LED BY THE
WORKING GROUP.
I WANT TO THANK DR. WOLD AND HER
COLLEAGUES FROM OUTSIDE AND
INSIDE GOVERNMENT FOR THIS
PROJECT.
THE REPORT WAS RELEASED LAST
JUNE.
THE REPORT LAST JUNE IDENTIFIED
FIVE THEMES, IMPROVING STUDY
DESIGN AND ACADEMIC RIGOR AND
BIAS IN REPORTING IMPROVING
METHODOLOGIC AND REPORTS AND
EVALUATING EFFECTIVENESS AND
COST WITHIN THEMES THERE WERE A
NUMBER OF RECOMMENDATIONS.
I WON'T GO EACH ONE BY ONE I'LL
REVIEW SOME OF THE EFFORTS TAKEN
PLACE SINCE THE REPORT WAS
RELEASED.
I WANT TO THANK MY COLLEAGUE THE
DEPUTY DIRECTOR OF THE OFFICE OF
EXTRAMURAL RESEARCH FOR HELPING
LEAD THESE EFFORTS.
WE'LL TRY TO DEVELOP A SHORT,
INTERMEDIATE AND LONG-TERM
RESPONSE TO THE REPORT'S
RECOMMENDATIONS.
I'LL TALK ABOUT A CONCEPT
CLEARANCE THAT CAME FROM THE
OFFICE OF RESEARCH
INFRASTRUCTURE PROGRAMS.
IN THE COURSE OF GOING THROUGH
THE REPORT, WE REALIZED WE HAVE
A NUMBER OF EXISTING RESOURCES
AT NIH THAT ANSWERED A NUMBER OF
THE RECOMMENDATIONS BUT ARE NOT
WELL MARKETED OR WELL
PUBLICIZED.
THERE MAY BE OPPORTUNITIES TO
LEVERAGE THEM TO A BETTER DEGREE
THAN WE CURRENTLY ARE.
I THEN WANT TO TAKE A STEP BACK
AND TALK ABOUT ONGOING EFFORTS
TO ENHANCE RIGOR WRIT LARGE NOT
JUST WITH ANIMAL AS WELL AS PEER
REVIEW.
I'LL SEND SHORT-TERM
CONSIDERATIONS FOR THE
DISCUSSION.
WE WILL LOOK AT ANIMAL MODELS IN
BIOMEDICAL RESEARCH.
THIS WAS OPENED FOR APPLICATIONS
AS OF FEBRUARY.
APPLICATIONS WILL CONTINUE TO BE
ACCEPTED THROUGH MARCH OF 2024.
THE GOALS ARE TO DEVELOP OR TO
FUND EXPLORATORY DEVELOPMENT AND
HIGHLY INNOVATIVE PROJECTS FOR
TOOLS AND RESOURCES FOR
VALIDATING ANIMAL MODELS AND FOR
ENHANCING THE RIGOR,
REPRODUCIBILITY AND
TRANSLATABILITY OF ANIMAL
RESEARCH.
THE POINT IS SINCE THIS IS AN OD
PROGRAM THE PROPOSALS HAVE TO
ADDRESS INTEREST OF MULTIPLE NIH
I.C.s OR ORGAN SYSTEMS OR IN
SOME WAY APPLICABLE TO MORE THAN
JUST THE INTEREST OF ONE I.C.
AND THERE'S BEEN A PRESENTATION
OF CONCEPT CLEARANCE TO THE
SO-CALLED COUNCIL OF COUNCILS.
WHAT THEY WANT TO DO IS TAKE THE
PROGRAM TIE HIGHER LEVEL.
BY FUNDING MERITORIOUS PROPOSALS
THROUGH A VARIETY OF FUND
MECHANISM.
ONE IS A TWO-YEAR R21,
RELATIVELY SMALL, SHORT-TERM
EXPLORATORY GRANT AND R10s AND
R24s OR U24s IS A COOPERATIVE
VERSION OF R24.
GRANTS THAT SUPPORT RESOURCES AS
WELL AS SMALL BUSINESS.
THE IDEA IS TO FUND PROJECTS ON
A GRANULAR LEVEL AND FOR A
LONGER PERIOD OF TIME.
THE PROPOSED PROJECTS HAVE TO
DEMONSTRATE HOW THE PROPOSED
RESOURCES OR TECHNOLOGIES WILL
IMPACT RIGOR AND REPRODUCIBILITY
OF ANIMAL STUDIES.
THIS WAS PRESENTED TO COUNCIL OF
COUNCILS MAY 19.
THERE WILL BE FOAs COMING OUT IN
THE NEAR FUTURE.
THERE'S GOING TO BE PLANNED
WORKSHOPS FROM SYMPOSIA AND ONE
WE'RE EXCITE ABOUT AND THE
OFFICE OF PORTFOLIO ANALYSIS DID
AN ANALYSIS OF ANIMAL MODELS
USED IN COVID RESEARCH.
THAT'S GOING LEAD TO A WORKSHOP
LATER IN THE YEAR ON ANIMAL
MODELS AND RELATED MODELS FOR
COVID RESEARCH AND LESSONS
LEARNED.
THERE'LL BE MENTION IN THE
REPORT AND THERE'LL BE A
WORKSHOP ON RIGOR AND
REPRODUCIBILITY AND ASSESSMENT
OF EQUIPMENT INSTRUMENT,
EXTRAMURAL CONSTRUCTION
PROJECTS.
THE INSTITUTE FOR LABORATORY
ANIMAL RESEARCH OR ILAR, THEY
PUT OUT A GUIDE ON ANIMAL
WELFARE WILL HAVE A PROJECT ON
EFFECTIVE COMMUNICATION ABOUT
SCIENTIFIC RESEARCH THAT
REQUIRES WORK WITH ANIMALS.
THERE WAS AN EXPLICIT
RECOMMENDATION IN THE REPORT
THAT WE NEED TO TAKE STEPS TO
INFORM THE PUBLIC, EDUCATE THE
PUBLIC, ENGAGE THE PUBLIC ON THE
IMPORTANCE OF ANIMAL RESEARCH.
NIH IS PLEASED WE'LL BE HELPING
TO SUPPORT THIS PARTICULAR
EFFORT.
IN THE COURSE OF OUR INTERNAL
DELIBERATIONS ON THE WORKING
GROUP REPORT, WE NOTED THERE ARE
A NUMBER OF RESOURCES WE ALREADY
HAVE OR ALREADY FUNDED THAT
ANSWER RECOMMENDATIONS THAT
PERHAPS COULD BE MARKETED
BETTER.
HERE'S TWO EXAMPLES.
A CLEARING HOUSE FOR TRAINING
MODULES ON RIGOR THAT COMES FROM
PROJECTS FUNDED BY NIGMS.
WE HAVE ONE ON STATISTICAL TOPIC
FOR REPRODUCIBLE ANIMAL RESEARCH
AND ANOTHER ON CONTROLS IN
ANIMAL STUDIES FOR RIGOR AND
REPRODUCIBILITY.
WE HAVE ON OUR OFFICE OF
EXTRAMURAL RESEARCH WEBSITE A
DEDICATED WEB PAGE ON RIGOR AND
REPRODUCIBILITY AND INCLUDED IN
THERE WE HAVE A SEPARATE PAGE ON
RESOURCES, ONE OF THE RESOURCES
WE DO LET THE PUBLIC KNOW ABOUT
IS A U.K.-BASED RESOURCE
AVAILABLE FOR FREE.
THERE'S SOME FUNDING AGENCIES
AROUND THE WORLD THAT REQUIRE
ITS USE.
IT'S QUITE POWERFUL.
A WAY TO PRODUCE GRAPHICS AND SO
ONE OF THE THINGS WE COULD DO
WHILE WE'RE NOT REQUIRING ITS
USE IS TO DO A BETTER JOB OF
LETTING THE PUBLIC KNOW THIS
EXISTS AND WE STRONGLY ENCOURAGE
RESEARCHERS TO INCLUDE THIS AS
THEY PREPARE THEIR PROPOSALS.
THERE'S ANOTHER INTERESTING
RESOURCE WHICH IS SUPPORTED BY
THE NIEA THE ALZHEIMER'S
PRECLINICAL EFFICACY DATABASE.
IT'S A DATABASE THEY SUPPORT IN
WHICH THE PUBLICATIONS THAT COME
OUT OF NIA FUNDED ALZHEIMER'S
RESEARCH CAN BE GRADED ON A
VARIETY OF RIGOR AND
TRANSPARENCY CRITERIA.
FOR EXAMPLE, THEY LOOK AT A
VARIETY OF DIFFERENT ITEMS SO
THE ITEMS ON THE RIGHT MIGHT BE
GENERAL RIGOR ITEMS LIKE
BLINDING, RANDOMIZATION, SEX AS
A BIOLOGICAL VARIABLE AND THE
ITEMS IN THE BLUE MIGHT BE THOSE
ITEMS THAT ARE MORE RELATED TO
SPECIFIC EXPERIMENTAL WORK AND
THE ITEMS IN BLUE ARE HIGH RATES
OF REPORTING AND THE ITEMS IN
RED ARE WHAT WE DISCUSSED IN THE
RACE AND REPORTING ARE
RELATIVELY LOW.
HERE'S AN EXAMPLE OF ONE
PARTICULAR STUDY THAT WAS
REPORTED OUT IN 2021 AND A
NUMBER OF CRITERIA BY WHICH THE
STUDY IS GRADED.
GREEN IS REPORTED AND RED WOULD
MEAN THOSE ITEMS WERE NOT
PROPERLY REPORTED.
I'M JUST PRESENTING THIS AS ONE
EXAMPLE.
ONE MIGHT THINK ABOUT OTHER
MEASURES THAT COULD BE
CONSIDERED AS WELL NOT INCLUDED
IN HERE.
WHEN WE DISCUSSED THIS WITH I.C.
DIRECTORS, ONE OF THE KEY
DISCUSSION POINTS IS THIS KIND
OF RESOURCE IS POTENTIALLY QUITE
VALUABLE.
IT HELPS US UNDERSTAND HOW
RIGOROUS AND TRANSPARENCY OUR
WORK MAY BE AND WE WOULD
ENCOURAGE OTHER I.C.s AND
PROGRAMS TO CONSIDER DOING
SOMETHING LIKE THIS.
I WANT TO TALK ABOUT ONGOING
RIGOR EFFORTS THAT DON'T
NECESSARILY APPLY TO ANIMAL
RESEARCH BUT NONETHELESS ARE
IMPORTANT.
THE CENTER FOR SCIENTIFIC REVIEW
BUT TOGETHER ONE OF THEIR OWN
WORKING GROUPS AND ASKED THEM TO
DEVELOP AN APPROACH TO
SIMPLIFYING REVIEW CRITERIA.
ONE PROBLEM WE'RE ALL FAMILIAR
WITH IS THAT THERE ARE MANY
REVIEW CRITERIA.
MANY ITEMS PEER REVIEW ARE BEING
ASKED TO LOOK AT.
THE RESULT IS LESS TIME MAY BE
SPENT BY PEER REVIEWERS TALKING
ABOUT THE RIGOR AND APPROACH OF
A PARTICULAR PROPOSAL AS OPPOSED
TO A VARIETY OF OTHER TOPICS.
I HAVE THE LINK ON THE SLIDE OF
A PUBLIC REPORT THAT WAS PUT
OUT.
THEY'RE PROPOSING SIMPLIFYING
REVIEW CRITERIA FROM THE CURRENT
FIVE TO THREE.
THERE'S A LOT MORE THAN THIS.
THE KEY POINT HERE IS MORE
EFFORT SHOULD BE CONCENTRATED ON
FOCUSSING ON THE IMPORTANCE OF
THE SCIENCE AND FEASIBILITY AND
RIGOR OF SCIENCE AND LESS ON A
VARIETY OF OTHER AREAS THAT MAY
BE IMPORTANT AND ARE IMPORTANT
BUT NONETHELESS MAY BE BETTER
HANDLED BY NIH STAFF.
THIS IS YOU MIGHT CALL A BRIEF
SNEAK PREVIEW.
THE WORK THE CSR ADVISORY
COUNCIL WORK GROUP HAS UNDER
GONE WORK AND NIH COMMITTEES
LOOKED AT THIS AND CONTINUE TO
WORK THROUGH IT.
WE PLAN TO BRING IT TO YOU IN
DECEMBER FOR FURTHER DISCUSSION.
THIS IS A WAY BY WHICH PEER
REVIEW CAN DO A BETTER JOB AND
RAISE THE LEVEL OF FEASIBILITY
AND RIGOR OVER AND ABOVE WHAT
THEY'RE DOING NOW.
WE THINK ANOTHER COMPONENT OF
RIGOR AND TRANSPARENCY IS
THROUGH DATA.
THAT'S SOMETHING WE'LL BE
DISCUSSING TOMORROW.
THERE'LL BE A FAIRLY EXTENSIVE
DISCUSSION.
WE ALSO SEE THIS AS A CRITICAL
COMPONENT OF ENHANCING RIGOR AND
TRANSPARENCY.
THE NINDS IS NOW FUNDING AN
EFFORT TO ENHANCE TRAINING IN
EXPERIMENTAL RIGOR.
SO THIS IS A PROGRAM WHICH IS
CALLED METER.
THESE ANNOUNCEMENTS ARE
CURRENTLY AVAILABLE THEY'RE
PUTTING TOGETHER A COORDINATING
CENTER AND GOING TO BE MULTIPLE
OTHER EFFORTS TO PUT TOGETHER A
VARIETY OF ONLINE RESOURCES TO
TEACH THE BIOMEDICAL RESEARCH
COMMUNITY FUNDAMENTAL PRINCIPLES
OF RIGOR, THE IDEA IS TO DEVELOP
AN INNOVATIVE ONLINE EDUCATIONAL
RESOURCE THAT CAN BE USED BY AN
ARRAY OF LEARNING ENVIRONMENTS
AND THIS WOULD INCLUDE ANIMAL
RESEARCH GIVEN IT'S A LARGE PART
OF OUR PORTFOLIO.
ALSO, NINDS HAS RECENTLY POSTED
A WORKSHOP ON CATALYZING
COMMUNITIES OF RESEARCH RIGOR
CHAMPIONS.
I'D POINT OUT ONE OF THE
CO-CHAIRS IS DR. KIMMER IS A
MEMBER OF OUR WORKING GROUP.
THERE'S A VIDEOCAST.
IT WAS A TERRIFIC WORKSHOP.
IT'S WORTH TAKING A LOOK AT.
WHAT I'D LIKE TO CONCLUDE WITH
IS STIMULATE DISCUSSION ABOUT
THREE ITEMS WE'RE THINKING
ABOUT.
WE'D LIKE YOUR FEEDBACK AS TO
WHETHER OR NOT WE SHOULD GO DOWN
THESE ROUTES.
THERE'S REPORTING ON THE ARRIVE
GUIDELINES.
THEY'VE BEEN OUT FOR A WHILE BUT
THEY'VE BEEN REVISED.
THE IDEA OF THE ARRIVE
GUIDELINES IS TO ENHANCE THE
DEGREE OF REPORTING AND
HOPEFULLY BY DOING THAT
STIMULATE MORE RIGOROUS AND
TRANSPARENT WORK.
THERE ARE MANY JOURNALS AND BY
MANY JOURNALS I MEAN PROBABLY
HUNDREDS OF JOURNALS THAT
ENCOURAGE OR EVEN REQUIRE THE
USE OF THE ARRIVE GUIDELINES.
WE'RE THINKING OF PUTTING OUT A
GUIDE NOTICE IN WHICH WE
STRONGLY ENCOURAGE RESEARCHERS
SUPPORTED BY NIH GRANTS TO USE
THE ARRIVE GUIDELINES WHEN THEY
ARE REPORTING THEIR RESULTS IN A
PEER REVIEW VENUE.
OUR QUESTION FOR YOU IS WHETHER
OR NOT YOU THINK THIS IS A GOOD
IDEA.
IF YOU THINK IT IS, WE CAN GO
AHEAD AND PUT THIS TOGETHER AND
PUBLISH IT AND MARKET IT.
THERE'S A NUMBER OF
RECOMMENDATIONS ABOUT ENHANCING
THE COLLABORATION OF
STATISTICIANS AND RESEARCHERS
WHO WORK WITH ANIMAL MODEL.
ONE THOUGHT IS PUT OUT FOAs
FUNDING STATISTICAL CORE TO
SUPPORT ANIMAL RESEARCHERS AND
UNDER RESOURCED INSTITUTIONS.
WE HOPE AT WELL RESOURCED
INSTITUTIONS THIS IS ALREADY
HAPPENING AND THERE ARE
COLLABORAT
COLLABORATIONS BETWEEN
STATISTICIANS AND ANIMAL
RESEARCHERS BUT MAYBE AT LESS
RESOURCED INSTITUTIONS MAYBE WE
CAN STIMULATE THIS KIND OF WORK
.
THE FINAL ITEM IS WE WERE
IMPRESSED BY WORK BEING DONE AND
IT MADE US THINK OF A PRIZE IN
WHICH WE WOULD HIGHLIGHT
EXEMPLARY WORK AND STUDY DESIGN
AND ANALYSIS IN ANIMAL RESEARCH.
IT WOULD BE A NON-MONETARY PRIZE
BUT NONETHELESS WOULD BE
PRESTIGIOUS AND GO THROUGH A
RIGOROUS VETTING PROCESS AT THE
NIH AND WOULD BE AN NIH TO
INSPIRE AND ENCOURAGE PEOPLE TO
RAISE THE LEVEL OF THEIR OWN
WORK.
I WILL STOP HERE AND HAPPY TO
HEAR YOUR THOUGHTS OR COMMENTS.
THANKS, VERY MUCH, MIKE.
WE OWE BARBARA THE FIRST WORD ON
OR COMMENTS.
>> TO NEW MEMBERS, IF THEY COME
TO YOU TO DO ONE OF THESE BEFORE
YOU COME TO YOUR FIRST MEETING,
WATCH OUT.
LARRY AND MIKE THANK YOU FOR
PUTTING THESE IN MOTION.
IT'S GREAT IT SEE THEM COME TO
REALITY.
QUESTIONS OPPOSED ON IMMEDIATE
ACTION ITEMS, NUMBER 3, THE
PRIZE TO HIGHLIGHT TERRIFIC WORK
IN THIS VEIN IS A NO-BRAINER.
PLEASE GO FORWARD TO MAKE IT
HAPPEN.
WITH RESPECT TO FUNDING
STATISTICAL CORES THAT IS
SOMETHING WE HAD ENTHUSIASM FOR
SEEDING IT AT UNDER RESOURCED
INSTITUTIONS GOES TOWARDS
LARRY'S PROBLEM AND MORE THE
REASON TO BE ENTHUSED.
AND WITH RESPECT TO THE ARRIVE
GUIDELINES, MY PERSONAL TAKE IS
THAT WAS SOMETHING THAT HAD A
LARGE DEGREE OF IMPETUS BROADLY
AND WITH THE CURRENT VERSION OF
ARRIVE IT WAS THE ESSENTIAL 10
ENCOURAGED.
IT'S A LITTLE BIT DIFFERENT IF
YOU GIVE A BROAD MANDATE TO THE
ENTIRETY OF ARRIVE WHICH IS A
GOOD THING BUT WON'T NECESSARILY
LAND WITH AS MUCH EFFICACY ON
THE BROAD COMMUNITY.
THAT'S A GOOD RECOMMENDATION.
OTHER PEOPLE BOTH ON THE
COMMITTEE AND OFF JUMP IN.
>> THANKS, BARBARA.
OTHER COMMENTS OR QUESTIONS
PEOPLE MAY HAVE?
>> THERE'S A COMMENT IN THE
CHAT.
LOOKS LIKE INNOVATION IS NO
LONGER A CONSIDERATION.
IT'S STILL A CONSIDERATION.
THEY'RE TAKING THE FIVE CRITERIA
AND NARROWING IT DOWN TO THREE.
ONE OF THE THREE IS THE WORK
IMPORTANT.
THAT WOULD CAPTURE SIGNIFICANCE
AND INNOVATION.
I DID NOT DO JUSTICE TO THE WORK
DONE HERE.
THERE'S BEEN A TREMENDOUS AMOUNT
OF WORK DONE THE LINK IS ON THE
SLIDE DECK BUT WE CAN PUT IT IN
THE CHAT.
WE'LL SPEND SIGNIFICANT TIME AT
ACD IN SEPTEMBER WITH MORE
DETAIL AND GET FEEDBACK THEN.
>> JUDITH.
>> I APPLAUD THIS AS WELL.
I THINK IT'S AN IMPORTANT
DIRECTION FOR NIH TO GO TO
BOLSTER THE RIGOR AND
REPRODUCIBILITY FOR NOT ONLY NIH
BUT SOCIETY.
WE NEED TO HAVE EVERYBODY ON OUR
SIDE.
ALSO FOSTERING RIGOROUS SCIENCE.
I LIKE THE CHANGE IN PEER REVIEW
BUT COULD SEE IT COULD BE DONE
POORLY.
I'M WONDERING WHAT THE PLAN IS
FOR IMPLEMENTING IT AND WORKING
WITH THE CSR AND STUDY SECTIONS
TO MAKE SURE IT'S IMPLEMENTED IN
THE RIGHT WAY.
RIGHT WAY MEANS THE BEST
SCIENCE.
I THINK YOU ASKED US TO GIVE
FEEDBACK ON ALL THE DIFFERENT
THINGS YOU SUGGESTED YOU SUGGEST
LOTS OF THINGS AND MAY BE
WORTHWHILE HAVING ANOTHER
SESSION OR SMALLER SESSION OR
MAYBE E-MAIL EXCHANGE BECAUSE
THERE WAS TOO MUCH TO SAY THIS
LOOKS GREAT AT LEAST FOR ME.
>> SO FOLLOW-UP MAY BE DONE BEST
ELECTRONICALLY AND COLLECTED AND
WE'D PROVIDE A SUMMARY AT THE
NEXT ACD MEETING SO EVERYBODY
UNDERSTANDS WHAT FEEDBACK WE
RECEIVED.
THE DECEMBER MEETING WILL LOOK
THROUGH THIS CAREFULLY FOR THE
REASONS YOU ANTICIPATED, JUDITH.
IMPLEMENTED CORRECTLY THIS COULD
BE A GREAT STEP FORWARD BUT
NEEDS TO BE IMPLEMENTED
CORRECTLY TO BE VALUE-ADDED.
THE ONLY WAY THAT WILL HAPPEN IS
IF WE SOCIALIZE IT AND WORK WITH
THE DIFFERENT GROUPS THIS WILL
AFFECT AND GET BUY-IN, FEEDBACK,
ETCETERA FROM THE VARIOUS
GROUPS.
A LOT OF WORK HAS BEEN DONE
ALREADY BUT AS WE GO MORE
BROADLY WITH THIS, THAT PIECE
CAN'T BE OVERLOOKED.
THANKS FOR THOSE COMMENTS.
OTHER COMMENTS OR QUESTIONS?
>> I WANT TO COME BACK TO THE
ISSUE OF RESOURCES.
THE ARRIVE RESOURCES ARE HELPFUL
BUT WHAT COMES UP PARTICULARLY
FOR LOTS OF PEOPLE WHETHER
RESOURCED OR NOT IS STATISTICAL
ANALYSIS PLAN.
YOUR SUPPORT FOR STATISTICAL
GROUPS IS GREAT.
WHAT I'D LIKE TO SEE IS IF YOU
WANT TO DO THIS EXPERIMENT TALK
TO OUR DATA SCIENTIST AND
STATISTICIANS WE CAN HELP.
SOMETHING AROUND THE ARRIVE MAY
BE A PLACE OR ALTERNATIVE
RELATED AND SOMEWHERE WHERE AN
UNDERGRADUATE OR GRADUATE
STUDENT WHEREVER THEY ARE CAN
GAIN STATISTICAL SUPPORT.
>> ARE YOU SUGGESTING NIH SHOULD
PROVIDE A RESOURCE?
>> IMAGINE A CENTER FOCUSSED ON
I U54 CENTER FOCUSSED ON RIGOR
AND REPRODUCIBILITY AND THEY
OFFER THAT TO A LARGE COMMUNITY
OF RESEARCHERS.
THEY GO A LONG WAY IN PROMOTING
A BROADER PORTFOLIO OF RESEARCH
ACROSS MULTIPLE INSTITUTIONS AND
REACHING A BROADER AUDIENCE OF
RESEARCHERS JUST AN IDEA.
>> CAN I ASK A FOLLOW-UP
QUESTION TO THAT OF WHAT YOUR
ACTUALLY SUGGEST.
THE DREAM WOULD BE A 9-1-1 STATS
LINE MANNED 24/7/365.
I DON'T THINK THAT WILL HAPPEN.
AND CREATING AN OUTREACH
COMPONENT THAT CREATES MODULES
THAT CAN BE USEFUL TO PEOPLE AND
IF THESE CENTERS ARISE IN AREAS
OF DIFFERENT EXPERTISE WHETHER
IT'S ALZHEIMER'S RESEARCH OR
SOMETHING ELSE, THERE WOULD BE
SOMETHING APPROPRIATE ACROSS
DIFFERENT AREAS ASSOCIATED WITH
DIFFERENT I.C.s.
IS THAT WHAT YOU'RE ENVISIONING?
>> THE MODULES IS A GOOD START.
>> PEOPLE NEED PEOPLE.
>> IF YOU WANT THE 9-1-1.
>> A STATISTICIAN WALKING YOU
THROUGH THE RIGHT QUESTIONS TO
ASK.
>> I THINK YOU IDENTIFIED THE
WANT.
>> FOR WELL RESOURCED
INSTITUTIONS THERE MAY NOT BE
ENOUGH TO SUPPORT A CORE OF
STATISTICIANS AND METHODOLOGISTS
WORKING TOGETHER BUT IF WE WERE
TO SUPPORT AN ENTITY WITH A
LARGE CORE OF HIGHLY QUALIFIED
PEOPLE SUPPORTING MULTIPLE
DIFFERENT INSTITUTIONS -- IN
FACT IT WOULD BE LIKE A U24.
WE'LL THINK MORE ABOUT THAT.
>> IF THIS WERE AVAILABLE TO AN
UNDER RESOURCED INSTITUTION,
THEY'D FIGURE OUT HOW TO USE IT.
THAT WAS PERHAPS CATALYZE
ENGAGEMENT SOONER AND MORE
OFTEN.
I WONDER IF THAT'S A DIFFERENT
PART OF THE SAME PROBLEM.
IN OTHER WORDS AS SAID 9-1-1,
YOU HAVE A HUMAN WHO LITERALLY
WALKS YOU THROUGH THE RIGHT
QUESTIONS.
BEGIN TO DEVELOP YOUR APPROACH
TO DO THINGS.
MOST LARGE INSTITUTIONS HAVE
SOMETHING LIKE THIS WITH THEIR
CLINICAL TRIALS GROUP.
YOU CAN'T GET PUBLISHED UNLESS
YOU DO THIS IN A ROBUST WAY.
IT'S DRIVEN BY I THINK CLINICAL
TRIALS.
MAYBE YOU CAN ELABORATE ON THE
SOFTWARE CHALLENGE.
>> SOFTWARE'S A GREAT WAY OF
DOING SOMETHING THE WAY OVER AND
OVER AGAIN IN TERMS OF
REPRODUCIBILITY.
IF YOU HAVE AN EXISTING SOFTWARE
TO MAINTAIN THE DATABASE THERE'S
SUPPORT OF THAT.
THIS IS A GREAT USE OF THE
COMMUNITY CAN USE THE TOOL THEY
ALREADY KNOW AND LOVE AND RUN
THAT ANALYSIS.
>> THANK YOU.
AND DAVID IS WONDERING OUT LOUD
IS THIS A MISSING RESOURCE OR
ARE WE MISSING ADEQUATE FUNDING?
>> I WAS TRIGGERED BY THE
SUGGESTION OF FUND CENTRAL POOL
RESOURCED AVAILABLE TO
ORGANIZATION DIDN'T HAVE ENOUGH
CRITICAL MASS TO CREATE THEIR
OWN.
WE COULD BUT IS IT MORE
EFFICIENT TO CREATE A NEW
CENT
CENTRAL 9-1-1 RESOURCE.
>> IT'S FRAMED BY MY IGNORANCE
OF MATH AND STATISTICS IN
GENERAL.
I NEED SOMEONE TO METAPHORICALLY
HOLD MY HAND AND HAVE ME ASK THE
RIGHT QUESTIONS.
I'M NOT SURE YOU'D GET THAT
UNLESS YOU HAD DEDICATED STAFF,
HOWEVER, THE MECHANISM WAS TO
ACCOMPLISH THAT.
MAYBE PEOPLE BEYOND MY SORRY
STATE OF KNOWLEDGE COULD
FUNCTION MORE INDEPENDENTLY.
WALTER DO YOU WANT TO TALK ABOUT
THE CENTER TO IMPROVE PRINCIPLES
OF RIGOROUS RESEARCH?
>> WE'VE BEEN THINKING ABOUT
THIS FOR A WHILE AND WE'RE
TRYING DIFFERENT THINGS.
WE HAD A WORKSHOP TRYING TO
BRING RIGOR CHAMPIONS IN FROM
AROUND THE COUNTRY TO GET OUT
PRINCIPLES OF RIGOROUS DESIGN
AND ANALYSIS THROUGHOUT THE
COUNTRY.
WE'RE ALSO PUTTING MONEY BEHIND
THE CENTER AND TRYING TO
COORDINATE THOSE ACTIVITIES AND
FOCUS INITIALLY ON DEVELOPING
EDUCATIONAL MATERIALS.
WE HAVE GRANTS OUT TO PEOPLE TO
DEVELOP THOSE MATERIALS.
THE CENTER WAS VALIDATE AND
DISTRIBUTE AND DISSEMINATE THEM.
AND A REAL PUSH TO IMPROVE THE
RIGOR OF RESEARCH.
>> WE'RE CALLING THIS
REPRODUCIBILITY BUT IT ALSO GOES
TO MISINFORMATION.
AGAIN, MAYBE I'M GETTING TOO
OLD.
I'M STARTING TO SEE IN OUR
ACADEMIC INSTITUTION THE RISE OF
PROFESSIONAL SKEPTICS BUILDING A
YEAR IN FINDING THE HOLES AND
FLAWS AND NON-REPRODUCIBILITY
PARTS OF WHAT WE DO AS
SCIENTIFIC EXPERIMENTS.
THOSE CRITICISM CAN START FROM A
GOOD POINT FROM CONSTRUCTIVE
FEEDBACK AND GOOD WILL BUT
OTHERS LATCH ON TO THOSE AND
AMPLIFY AND EXPAND AND IT LEADS
TO DISRUPT GENERALLY IN SCIENCE.
I DON'T THINK THIS IS SOLVABLE
WITH A U24.
IT'S WAY BROADER AND COVID HAS
HIGHLIGHTED HOW BAD THIS CAN
GET.
THIS SHOULD BE AMPLIFIED MORE
THAN IN THIS BIT OF FUNDING HERE
AND THERE.
>> THERE'S NO EQUIVALENT OF THE
ANIMAL RESEARCH NIH WIDE BUT I'D
SAY THE NINDS DOES DO SO
COHERENT THINGS IN THIS SPACE
AND NIA.
WALTER IS THAT NOT TRUE FOR
NINDS?
>> NO, WE'VE BEEN TRYING THINGS
OVER TIME BUT WE'RE PUTTING MORE
MONEY INTO IT NOW.
>> IT'S ASTOUNDING THERE'S IN
SIDE FOR THE ANIMAL SIDE.
>> ATUL, STARTING WITH THE FIRST
CALL FOR CTSAs, THERE WAS
EMBEDDED THE OPPORTUNITY FOR
SCIENCE.
THAT DOESN'T GO FORWARD.
>> TIME TO RESURRECT IT.
>> OKAY.
I THINK WE'RE BEYOND TIME.
TARA DID NOT RING THE BELL.
>> DID I RING THE BELL.
WE HAVE LEARNED THE BELL CANNOT
BE HEARD.
>> IT COULD VERY WELL BE BECAUSE
I DON'T HEAR HIGH PITCHES
ANYMORE, AT LEAST THAT'S WHAT MY
WIFE REPORTS.
>> I DIDN'T HEAR ANYTHING.
>> WE DIDN'T HEAR IT.
>> RING THE BELL NOW.
>> IT'S REPRODUCIBLE.
>> THAT'S FOR SURE.
>> OKAY.
>> THE PROBLEM WITH ZOOM IS IF
NORTHBOUND ELSE IS SPEAKING, IT
DOESN'T ALLOW TO HEAR A
COMPETING NOISE.
APOLOGIES FOR GOING BEYOND AND
I'LL KEEP CLOSING COMMENTS TO A
MINIMUM.
THANK YOU TO ALL WHO WERE ABLE
TO STAY WITH US FOR THE BETTER
PART OF A FULL DAY.
OF COURSE TO ALL THE SPEAKERS
WHO DO A LOT OF PREPARATION FOR
THESE AND WE LOOK FORWARD TO SEE
YOU ALL AGAIN TOMORROW.
THE DAY TOMORROW'S A BIT SHORTER
BUT NEVERTHELESS VERY IMPORTANT
AS YOU HAVE HEARD.
I THINK WE GAVE YOU THE PREVIEW
FOR WHAT TOMORROW AND WE LOOK
FORWARD TO HEARING FROM ALL OF
YOU.
WITH THAT, ANYTHING I LEFT OUT?
>> WE'LL TRY A DIFFERENT BELL
TOMORROW.
>> THANK YOU ALL VERY MUCH.
I LOOK FORWARD TO DAY TWO OF THE
ADVISORY COUNCIL.
HAVE A GOOD EVENING.