>> GOOD AFTERNOON OR MORNING,
EVERYBODY, DEPENDING WHERE YOU
ARE LOCATED.
I WOULD LIKE TO WELCOME YOU TO
THIS OPEN SESSION OF THE
NATIONAL ADVISORY COUNCIL FOR
HUMAN GENOME RESEARCH,
INCLUDING THOSE OF YOU WHO ARE
HERE IN PERSON, WE HAVE MEMBERS
OF OUR NHGRI STAFF HERE IN THE
ROOM.
WITH ME.
AS WELL AS OUR COUNCILMEMBER
WHO'S ARE ATTENDING VIRTUALLY
AND ANYONE WHO IS JOINING US
OVER THE LIVE STREAM.
I AM OFFICIALLY GAVELING US TO
A START.
THEY ACTUALLY GIVE YOU A GAVEL
AND TURNING IT OVER TO OUR
EXECUTIVE SECRETARY FOR THE
COUNCIL, JEN TROYER.
>> I WOULD LIKE TO JOIN CAROLYN
IN INVITING EVERYBODY.
BEFORE WE GET STARTED, WE HAVE
A COUPLE OF BUSINESS ITEMS TO
ATTEND TO.
ONE OF THESE, I'M SUPPOSED TO
INTRODUCE OUR NEW
COUNCILMEMBERS, NHGRI STAFF,
LIAISONS AND GUESTS.
WE DON'T HAVE ANY NEW
COUNCILMEMBERS TO INTRODUCE.
AND CAROLYN HAS A FEW SLIDES
FOR STAFF MEMBERS.
BUT I WILL SAY THAT NHGRI IS
DELIGHTED TO WELCOME BACK
CAROLYN HUTTER AS OUR NEW
ACTING DIRECTOR.
AND THEN I WOULD ALSO LIKE TO
INVITE, ACKNOWLEDGE OUR
LIAISONS.
GEORGIA FROM GENETIC ALLIANCE.
ALLEN FROM THE INTERNATIONAL
SOCIETY OF NURSES AND GENETICS,
LILAH JAMAL FROM THE NATIONAL
SOCIETY OF GENETIC COUNSELORS
AND WELCOME ANY NIH COLLEAGUES
JOINING US FOR THIS OPEN
SESSION, AS WELL AS ALL OF YOU
WATCHING.
SO THE FIRST ORDER OF BUSINESS
FOR TODAY IS BECAUSE WE HAVE
NOT HAD AN OPEN SESSION SINCE
SEPTEMBER, WE NEED TO APPROVE
THE MINUTES FROM OUR SEPTEMBER
MEETING.
THESE HAVE BEEN PROVIDED AS A
DOCUMENT TO COUNCIL AND ONCE
THEY ARE APPROVED WILL ALSO BE
AVAILABLE TO ANYONE ONLINE.
SO I AM GOING TO ASK OUR
COUNCILMEMBERS FOR THE FIRST
TIME VOTING ELECTRONICALLY, AS
WELL AS BY RAISING HANDS.
SO FIRST OF ALL, I'M GOING TO
ASK YOU IN THE OPEN SESSION
AGENDA TAB THERE'S A VOTE TO
APPROVE THE NHGRI COUNCIL
MEETING MINUTES FROM SEPTEMBER
2024.
IF YOU CAN GO INTO THAT, AND
EITHER APPROVE OR DISAPPROVE,
OR ABSTAIN, IF WERE NOT PRESENT
THEN, YOU CAN ABSTAIN.
>> DON'T WE HAVE TO HAVE A
MOTION AND SECOND TO VOTE?
>> YES, SO CAN WE HAVE A MOTION
TO APPROVE THOSE MINUTES BY
HAND.
WE WILL DO THAT.
>> MOTION.
>> GREAT.
AND IT LOOKS LIKE THERE ARE
SECONDS AND THIRDS, SO WE ARE
ALL SET THERE.
NOW I'M GOING TO ASK YOU TO DO
THE HAND RAISING.
SO ALL APPROVE, PLEASE RAISE
YOUR HAND.
EXCELLENT.
ANY DISAPPROVE?
NANCY, I ASSUME THAT WAS AN
APPROVE.
AND THEN NOBODY ABSTAINING, SO
WE ARE ALL SET.
SO THANK YOU VERY MUCH.
THAT ORDER OF BUSINESS IS DONE.
THE SECOND IS ONTO OUR CONFLICT
OF INTEREST STATEMENT.
WE HAD OUR CLOSED SESSION OF
COUNCIL YESTERDAY.
SO THIS REFERS TO ALL OF THE
APPLICATIONS THAT WERE
DISCUSSED BY COUNCIL AT THE
CLOSED SESSION MEETING
YESTERDAY.
COUNCILMEMBERS ARE REQUIRED TO
LEAVE THE MEETING ROOM WHEN
APPLICATIONS SUBMITTED BY THEIR
OWN ORGANIZATION ARE BEING
INDIVIDUALLY DISCUSSED.
IN THE CASE OF STATE HIGHER
EDUCATION OR OTHER SYSTEMS WITH
MULTIPLE CAMPUS THAT'S ARE
GEOGRAPHICALLY SEPARATED YOUR
OWN ORGANIZATION MEANS THE
ENTIRE SYSTEM EXCEPT WHERE A
DETERMINATION HAS BEEN MADE THE
COMPONENTS ARE SEPARATE
ORGANIZATIONS FOR PURPOSES OF
DETERMINING CONFLICT OF
INTEREST.
ALL PEOPLE PRESENT SHOULD AVOID
SITUATIONS THAT COULD GIVE RISE
TO CHARGES OF CONFLICT OF
INTEREST, WHETHER REAL OR
APPARENT.
FOR EXAMPLE, NO ONE
PARTICIPATES IN THE
DELIBERATIONS AND ACTIONS ON
ANY APPLICATION FROM OR
INVOLVING THEIR SPOUSE,
PARTNER, CHILD, A RECENT
STUDENT, A RECENT TEACHER, A
PROFESSIONAL COLLABORATOR WITH
WHOM THEY HAVE WORKED CLOSELY.
A CLOSE FRIEND, OR A SCIENTIST
WITH WHOM THEY HAVE HAD LONG
STANDING SCIENTIFIC OR PERSONAL
DIFFERENCES.
THE NHGRI STAFF HAVE INSTRUCTED
COUNCILMEMBERS ACCORDINGLY.
IN COUNCIL ACTIONS IN WHICH
COUNCILMEMBERS VOTE ON A BLOCK
OF APPLICATIONS WITHOUT
DISCUSSING ANY INDIVIDUAL ONE,
FOR EXAMPLE, THE ON BLOCK
ACTION, THEIR VOTE DIDN'T APPLY
TO ANY APPLICATIONS FROM ANY
INSTITUTIONS OR INDIVIDUALS
FULFILLING THE CRITERIA ABOVE.
ALL RIGHT, THAT BEING SAID, WE
CAN MOVE ONTO AN UPDATE FROM
OUR ACTING DIRECTOR, CAROLYN,
OVER TO YOU.
>> EXCELLENT, THANK YOU SO MUCH.
CAN WE PLEASE PULL UP MY SLIDES?
EXCELLENT.
AGAIN, MY NAME IS CAROLYN
HUTTER, THE ACTING DIRECTOR OF
NHGRI, I TOOK THIS POSITION ON
MAY 5th.
I WILL DISCUSS A LITTLE BIT
MORE WHEN I DO NHGRI UPDATES AS
TO WHY I'M IN THIS ROLE.
BUT AS BACKGROUND, I HAVE
TRAINING IN EPIDEMIOLOGY,
BIOSTATISTICS AND GENETICS, AND
I'VE BEEN AT THE NIH SINCE 2012.
I WAS A PROGRAM DIRECTOR AND
THEN DIVISION DIRECTOR AT
NHCBI, I LEFT THE OFFICE OF
STRATEGIC COORDINATION WHICH
OVERSEES THE COMMON FUND BUT
WAS THEN ASKED TO COME BACK
INTO THIS ROLE WITH THE
DEPARTURE OF ERIC GREEN AND BEN
SPOTTAM.
THIS WON'T BE IF YOU ARE A
REGULAR WATCHER OF THE NHGRI
COUNCIL, THIS WON'T BE LIKE A
REGULAR DIRECTOR'S REPORT.
I AM GOING TO GIVE SOME UPDATES
BOTH FIRST AT THE NIH LEVEL,
AND THEN MOVING TO INSTITUTE OR
NHGRI LEVEL UPDATES.
SO, MY FIRST UPDATE AT THE NIH
LEVEL IS THAT WE DO HAVE A NEW
NIH DIRECTOR.
HE STARTED IN EARLY APRIL.
DR. JAYANTA OR JAY,
BHATTACHARYA.
HE HAS COME TO US FROM STANFORD
WHERE HE DID BOTH HIS TRAINING
AND HAD A FACULTY POSITION.
HE HAS GIVEN SEVERAL PUBLIC
TALKS OUTLINING HIS VISION.
I PARTICULARLY RECOMMEND IF YOU
WANT TO SEE MORE OF WHAT HE IS
INTERESTED FROM HIS OWN WORDS,
THE NINDS COUNCIL, WHICH IS
SIMILAR TO THIS COUNCIL,
AVAILABLE ON THE NIH VIDEOCAST,
YOU CAN GO BACK TO PRIOR EVENTS.
IF YOU GO TO THAT ALMOST
EXACTLY THE 30 MINUTE MARK, HE
BEGINS HIS REMARKS.
MAKE AMERICA HEALTHY AGAIN
AGENDA.
HE ALSO HAS A REALLY STRONG
PASSION AROUND ENSURING
RELIABLE RESULTS AND THIS
INCLUDES A FOCUS ON REPLICATION
AND WAYS TO MAKE SCIENCE
REPLICAABLE, REPRODUCIBLE AND
GENERALIZABLE.
HE EMPHASIZES MAKING BIG
ADVANCES WITH NIH RECONNECTING
TO OUR CORE MISSION FINDING THE
MOST INNOVATIVE BIOMEDICAL
RESEARCH TO MOVE FORWARD.
AN INTEREST IN MAINTAINING
SAFETY AND TRANSPARENCY THROUGH
APPROPRIATE REGULATION, POLICY,
ET CETERA.
AND ENCOURAGING ACADEMIC
FREEDOM, INCLUDING ALLOWING THE
EXPRESSION OF DISAGREEMENT AND
QUESTIONING OF SCIENTIFIC DOGMA.
SO AGAIN, THERE ARE PUBLIC
PLACES WHERE YOU CAN SEE MORE
AND I THINK HE HAS PLANS TO PUT
FORWARD SOME ADDITIONAL
INFORMATION HIGHLIGHTING HIS
AGENDA.
IN ADDITION TO A NEW NIH
DIRECTOR WE HAVE HAD CRITICAL
CHANGES AT THE LEADERSHIP LEVEL.
I'M NOT REPRESENTING ALL OF
THEM.
BUT THERE WERE SOME KEY NIH
LEADERSHIP RETIREMENTS THAT
HAVE HAPPENED SINCE JANUARY,
INCLUDING DR. TABAK, NIH
PRINCIPAL DEPUTY DIRECTOR.
DR. LAUER, AND JOHN BURKLOW,
CHIEF OF STAFF.
IN TERMS OF NEW COMING IN,
MATTHEW MEMOLI, WHO WAS AN
INTRAMURAL INVESTIGATOR, WAS
THE FIRST ACTING NIH DIRECTOR
AND NOW ROLE OF PRINCIPAL
DEPUTY DIRECTOR.
JOHN LORSCH, THE LONG TERM
NIHGMS DIRECTOR IS SERVING AS
AT ACTING DEPUTY IT DRENGTOR
FOR EXTRAMURAL RESEARCH.
NICOLE KLEINSTREUER HAS COME IN
TO BE DEPUTY DIRECTOR FOR
POUGHKEEPSIE.
SEANA CRANSTON IS NIH CHIEF OF
STAFF, AND ERIC SCHNABEL IS NIH
CHIEF OPERATING OFFICER THAT
STARLTED UNDER THE CURRENT
ADMINISTRATION.
I AM NOT ALONE IN MY ACTING
ROLE.
IN JANUARY THERE WERE ALREADY
TWO ACTING DIRECTORS AT NIH AND
BECAUSE OF THE LEAVING OF
SHANNON, DEANA, ALLISTER RA,
ERIC GREEN, SHELLY AND JANEEN
MARAZIO, WE HAVE NEW ACTING
DIRECTORS, YOU CAN SEE THEM,
NINR, NICHD, NIMHD, NHGRI,
NIMH, NIAID.
COURTNEY, ALLISON, MONICA,
CAROLYN, ANDREA, JEFF.
THE FISCAL YEAR 2025 ENACTED
BUDGET IS BASED ON THE
CONTINUATION OF THE FY 2024
ENACTED APPROPRIATION.
THE NIH BUDGET WENT DOWN
SLIGHTLY.
MOSTLY BECAUSE OF 21st CENTURY
CURES, CUTS THAT IMPACTED ALL
OF US PROGRAM AND BRAIN
INITIATIVE, BUT THE 47.3 TO 47
BILLION, AND NHGRI STAYED
STEADY AT JUST OVER 660 MILLION
DOLLARS.
IF YOU LOOK FORWARD TO FY '26
WE DON'T KNOW WHAT THE BUDGET
IS GOING TO BE YET, BUT THE
PRESIDENT PUT OUT THE FY '26
PRESIDENT'S BUDGET THAT CUTS
THE NIH BUDGET FROM 47 BILLION
DOWN TO JUST UNDER $28 BILLION,
WHICH IS ABOUT A 40% DECREASE
TO THE BUDGET.
FOR NHGRI, I DON'T HAVE A
NUMBER IN THAT CELL FOR A
REASON, BECAUSE UNDER THE
PRESIDENT'S PROPOSED BUDGET,
NHGRI MOVES INTO A NEW
REORGANIZATION.
SO IN ADDITION TO PROPOSING A
40% CUT, THE PRESIDENT'S BUDGET
HAS ADDITIONAL ACTIVITIES
AROUND INDIRECT COSTS, SALARY
CAPS, SOME OTHER THINGS
MULTI-YEAR FUNDING ET CETERA.
AND PROPOSES A REORGANIZATION
FROM 27 INSTITUTES DOWN TO 11.
SO THIS INCLUDES, I'M NOT GOING
TO READ THROUGH ALL THIS, BUT
THE NATIONAL HEART LUNG AND
BLOOD INSTITUTE.
NATIONAL INSTITUTE OF ARTHRITIS
AND MOUSSE LO SKELETAL AND SKIN
DISEASE AND NATIONAL INSTITUTE
OF DIABETES AND DIGESTIVE AND
KIDNEY DISEASES MOVING INTO
NATIONAL INSTITUTE OF BODY
SYSTEMS.
NHGRI COMES IN HERE JOINING
NIGMS, NLM AND NATIONAL
INSTITUTE.
NIAID STAY THE SAME.
NATIONAL INSTITUTE FOR
BIOMEDICAL SCIENCES MOVES OUT
OF NIH TO A NEWLY FORMED
ADMINISTRATION FOR HEALTHY
AMERICA WITHIN HHS AND THIS
BUDGET PROPOSES AN ELIMINATION
OF THE NATIONAL INSTITUTE FOR
NURSING RESEARCH, NATIONAL
CENTER FOR COMPLIMENTARY AND
INTEGRATIVE HEALTH,
PHARMACOGENOMICKERITY AND
MINORITY HEALTH AND HEALTH
DISPARITIES.
IF YOU LOOK AT THIS
NEWLY-FORMED NIMGS, IT'S BUDGET
OF THE NEW INSTITUTE IS ABOUT
40% OF WHAT YOU GET IF YOU
ADDED THE CURRENT BUDGETS OF
THE FIVE INSTITUTES BEING PUT
TOGETHER.
AND THAT'S GENERALLY TRUE
ACROSS-THE-BOARD.
THAT 40% DECREASE IS GENERALLY
HOW THEY APPLIED IT
ACROSS-THE-BOARD FOR THIS
PROPOSED BUDGET.
I WILL ALSO REMIND EVERYBODY
THOUGH THAT THE PRESIDENT'S
BUDGET IS JUST ONE STEP IN HOW
YOU CREATE A U.S. FEDERAL
BUDGET.
SO THIS OUTLINE, THIS IS FROM A
WEBSITE, HOW DO WE MAKE THE
BUDGET AND THERE'S MORE TO IT
THAN THIS.
THE PRESIDENT'S BUDGET IS SORT
OF STEP THREE, AND WHERE WE ARE
NOW IS IN STEP FOUR WHERE THE
BUDGET IS BEING CONSIDERED AT
THE HOUSE AND SENATE LEVEL,
SORT OF BEING EVALUATED BY
SUBCOMMITTEES WHO ARE HOLDING
HEARINGS.
AND ACTUALLY, JUST LAST WEEK,
THE SENATE LABOR, HEALTH AND
HUMAN SERVICES EDUCATION AND
RELATED AGENCIES SUBCOMMITTEE
HELD A HER HEARING FOR THE
PRESIDENT'S FISCAL YEAR '26
BUDGET, REQUEST FOR NATIONAL
INSTITUTE OF HEALTH, DR.
BHATTACHARYA WAS AVAILABLE FOR
THAT AND YOU CAN FIND THAT
ONLINE.
I WANT TO NOTE IN ADDITION TO
BUDGET CHANGES THERE'S BEEN A
NUMBER OF OF POLICY UPDATES.
THESE ARE TWO WEBSITES.
ON EACH OF THESE SLIDES, WHERE
THERE'S THESE QR CODES THESE
WILL TAKE YOU TO THE
APPROPRIATE WEBSITE.
WE HAVE, THESE ARE WEBSITES YOU
CAN GO TO TO FIND SOME UPDATED
INFORMATION ABOUT POLICY
UPDATES.
THE NEXT TWO SLIDES GO OVER KEY
POLICY UPDATES.
I WILL GO THROUGH THIS QUITE
QUICKLY BUT I STILL THINK IT'S
IMPORTANT TO THE EXTENT THERE'S
MEMBERS OF THE EXTRAMURAL
COMMUNITY TO BE WATCHING THESE
TO BE AWARE OF THESE.
I SORT OF GROUPED THEM INTO
SOME KEY AREAS.
THE FIRST IS AROUND TRAINING
AND EARLY CAREER.
SO MENTORED CAREER, DEVELOPMENT
AWARD ELIGIBILITY WAS EXTENDED
FOR INDIVIDUALS WHOSE AWARDS
WERE TERMINATED EARLY.
THERE WAS ALSO AN EXTENSION OF
E.S.I. STATUS FOR PEOPLE WHOSE
E.S.I.'S STATUS WAS GOING TO
HAVE EXPIRED BETWEEN OCTOBER OF
2024 AND JULY OF 2025.
THIS NEXT BULLET, THERE'S
ACTUALLY, THERE WAS AN EARLY
EXPIRATION DATE TO THE PARENT
FELLOWSHIP NOFO'S BUT THOSE GOT
RELEASED EITHER FRIDAY AND
MONDAY, SO BETWEEN WHEN I
FINALIZED THESE SLIDES AND
TODAY.
IF YOU GO, AND THERE'S SOME
CHANGES TO LATEST FOREIGN
PACKAGE BUT IF YOU LOOK AT THE
NEW NOFO'S FOR THOSE, NOTICE OF
FUNDING OPPORTUNITIES, YOU CAN
FIND OUT ABOUT THAT.
AND THERE WAS SOME CHANGES TO
THE CHILD CARE COSTS IN THE
INSTITUTIONAL RESEARCH TRAINING
AWARDS.
FOR FOREIGN SUBAWARDS AND
COLLABORATIONS, NIH IS NO
LONGER ISSUING AWARDS TO
DOMESTIC OR FOREIGN ENTITIES
THAT INCLUDE SUBAWARDS.
THIS CAME OUT IN NOT-OD-25-104.
THERE WILL BE A NEW AWARD
STRUCTURE IN THE INTERIM
INSTITUTIONS CAN RENEGOTIATE OR
TO TRANSFER THE WORK TO EITHER
THE PRIME OR TO A DIFFERENT
DOMESTIC SUB RECIPIENT.
AND THEN THERE WAS ALSO A
NOTICE REMINDING PEOPLE THAT IF
YOU HAVE AN INDICATION OF
FOREIGN ACTIVITIES OR
INTERNATIONAL COLLABORATIONS IN
YOUR AWARDS YOU NEED TO INCLUDE
A FOREIGN JUSTIFICATION.
THAT USED TO BE SOMETHING THAT
COULD SOMETIMES BE HANDLED IN
THE JUST IN TIME PROCESS.
THAT'S NO LONGER THE CASE, IF
THAT'S NOT AVAILABLE, THE
AWARDS WILL BE WITHDRAWN.
THAT WAS A NOTICE OF INCREASED
ENFORCEMENT OF AN EXISTING
POLICY.
OTHER AREAS WHERE THERE'S SOME
KEY POLICIES, THE FIRST ONE
THAT CAME OUT WAS A CHANGE TO
THE INDIRECT COST RATE, THAT
ONE IS CURRENTLY ON HOLD.
A MAJOR CHANGE IS THAT ALL
REQUESTS FOR NO COST EXTENSIONS
NOW MUST BE SUBMITTED AS A
PRIOR APPROVAL REQUEST.
THERE'S BEEN SOME BACK AND
FORTH ABOUT A NEW CIVIL RIGHTS
TERM THAT WAS ADDED.
AND THEN ON HOLD.
THERE'S AN UPDATED NOTICE
AROUND THAT.
THE NIH PUBLIC ACCESS POLICY,
WHICH HAD ALWAYS BEEN IN WORKS,
THE EFFECTIVE DATE FOR THAT GOT
MOVED FORWARD, SO IT ACTUALLY
WILL START JULY 1st OR
BEGINNING OF NEXT MONTH.
NRZ BEEN A COUPLE THINGS I
COULD HAVE GROUPED TOGETHER
SORT OF AROUND SOME OF THAT
SAFETY AND TRANSPARENCY SPACE.
SO SOME INFORMATION ABOUT GAIN
OF FUNCTION RESEARCH, ONE
ADDRESSING IN A RELATIONSHIP TO
RECOMBINANT OR SYNTHETIC
NUCLEIC ACID MOLECULES THAT'S
THE TITLE, PUBLICLY POST
INSTITUTIONAL BIO SAFETY
COMMITTEE ROSTERS AND POSTING
MEETING MINUTES GOING FORWARD.
FINALLY, THIS IS RELEVANT TO
OUR COMMUNITY IN THE GDS SPACE,
THERE WAS NOTICE PUT OUT ABOUT
GENERATIVE AI AND CONTROLLED
ACCESS TO GENOMIC DATA.
SO APPROVED USERS MAY DEVELOP
AI MODELS USING CONTROLLED
ACCESS DATA BUT THEY CAN ONLY
SHARE THOSE WITH APPROVED
COLLABORATORS AND MAY NOT
RETAIN THE MODELS OR PARAMETERS
AFTER CLOSE OUT OF THE PROJECT.
NOW I WILL NOTE, IN THIS
SPECIFIC AREA, THERE'S
RELATEDLY AN R.F.I. ON
RESPONSIBLE DEVELOPMENT AND
SHARING OF GENERATIVE A.I.
TOOLS USING ACCESS DATA.
THE PURPOSE IS GAIN INPUT ON
STRATEGIES TO PREVENT LEAKAGE
OF SENSITIVE HUMAN GENOMIC DATA
WHEN SHARING MODELS.
LOOKING TO STRIKE A BALANCE
BETWEEN DATA SECURITY WHILE
ALSO FOSTERING BROAD INNOVATION
IN THIS SPACE.
SO WE ARE SEEKING PUBLIC
FEEDBACK ON THE TYPES AND
DEGREES OF RISKS ASSOCIATED
WITH GENERATIVE AI MODELS USING
CONTROLLED ACCESS DATA AS
PRACTICAL STRATEGIES AND
TECHNOLOGIES THAT COULD BE USED
TO MITIGATE THESE RISKS.
HERE IS INFORMATION ELECTRONIC
COMMENTS WILL BE ACCEPTED
THROUGH JULY 16th.
IF YOU WANT TO KNOW MORE YOU
CAN FOLLOW THIS NOT-OD-25-118
TO GET THE INFORMATION
INCLUDING HOW TO RESPOND.
SO WE ALSO CONTINUE TO HAVE
FUNDING OPPORTUNITIES AVAILABLE
FROM THE NIH FUNDING
OPPORTUNITIES, THE NIH GUIDE
FOR CONTRACTS, THAT'S THE
STANDARD PAGE YOU HAVE ALWAYS
GONE TO.
THERE ACTUALLY HAVE BEEN IN THE
LAST SEVERAL DAYS A NUMBER OF
NOTICE OF FUNDING
OPPORTUNITIES, THERE HAVEN'T
BEEN ANY FOR A WHILE BUT THERE
HAVE NOW BEEN, SORRY, MY WATCH
IS BUZZING.
THERE'S NOW BEEN SOME UP THERE,
SO I ENCOURAGE YOU TO CONTINUE
TO LOOK AT THE NIH GUIDE.
BUT IN ADDITION THERE'S BEEN
SOME CHANGES TO OUR PROCESS AND
SO, BEFORE THINGS GO TO THE
GUIDE, THERE'S GOING TO BE
THESE FEDERAL-WIDE FORECASTS.
SO YOU CAN GO TO THIS PAGE TO
FIND WHAT IS HAPPENING IN THE
FORECAST SPACE.
IF YOU WANT TO FIND INITIATIVES
FORECASTED SPECIFICALLY
SUPPORTED BY NHGRI, WE SHOULD
WORK IN THE FUTURE TO MAKE SURE
WE HAVE NHGRI IN THERE WELL
ENOUGH IT SHOWS UP AS A SEARCH
TERM.
BUT IF YOU REALLY WANT TO MAKE
SURE YOU GET EVERYTHING YOU
SEARCH FOR OUR SYSTEM'S
LISTING, SEARCH FOR 93.172.
THIS IS WHERE THINGS WILL BE
COMING FORWARD AHEAD OF THEM
WINDING UP IN THE GUIDE.
WE ENCOURAGE PEOPLE TO USE THIS.
IT'S NOT EXACTLY THE SAME AS
WHEN WE HAD A NOTICE OF INTENT
TO PUBLISH BUT IT WILL GIVE YOU
AN IDEA OF WHEN THINGS COME
FORWARD OR MAY COME FORWARD IN
THE FUTURE.
THERE'S NO GUARANTY THAT THINGS
THAT ARE FORECASTED WILL MAKE
IT ALL THE WAY TO BEING A NOFO,
BUT IT COULD GIVE YOU AN IDEA
WHAT COULD BE COMING IN THE
PIPELINE AND THINGS YOU MIGHT
BE LOOKING AT OR INTERESTED IN.
SO FOR EXAMPLE, THE THINGS THAT
WE ARE PRESENTING IN COUNCIL
TODAY, IF THEY CONTINUE TO MOVE
FORWARD, IF THEY GET COUNCIL
APPROVAL AND WE CONTINUE TO
MOVE FORWARD, THEY WILL APPEAR
FIRST IN THIS FEDERAL-WIDE
FORECAST SPACE BEFORE THEY
POTENTIALLY GO ONTO BECOMING
ACTUAL FUNDING OPPORTUNITIES.
ANOTHER MAJOR CHANGE, I'M SORT
OF WORKING US FROM POLICY, THAT
IS THE UPSTREAM POLICY OF
THINGS YOU NEED TO KNOW, NOTICE
OF FUNDING AWARDS.
MOVING INTO THE REVIEW SPACE.
A MAJOR CHANGE THAT'S HAPPENED
AT NIH IS SCIENTIFIC REVIEW HAS
BEEN CONSOLIDATED.
SO PREVIOUSLY SCIENTIFIC REVIEW
WAS HANDLED THROUGH SCIENTIFIC
REVIEW AT CSR, WHICH FOCUSED
PRIMARILY ON INVESTIGATIVE WORK
THROUGH THE PARENT NOFO'S, AS
WELL AS COLLABORATIVE
INITIATIVES AND THEN THERE WERE
SCIENTIFIC REVIEW OFFICERS OR
SRO'S AT INDIVIDUAL INSTITUTES
AND CENTERS WHO ORGANIZED THEIR
OWN REVIEWS.
FOCUSING TYPICALLY ON COMPLEX
MECHANISMS, ON THINGS THAT CAME
IN UNDER SPECIFIC NOFO'S FOR
INITIATIVES AS WELL AS SOME OF
OUR TRAINING PORTFOLIO.
SO NOW, STARTING WITH
APPLICATIONS GOING TO OCTOBER
COUNCIL AND BEYOND, SO STARTING
WITH THE REVIEW THAT IS
HAPPENING THIS SUMMER, ALL OF
THIS HAS BEEN CONSOLIDATED INTO
THE CSR.
THIS IS GOING TO BE A MAJOR
CHANGE ACROSS NIH.
WHEN YOU THINK ABOUT IT FROM A
NHGRI PERSPECTIVE.
JUST ABOUT HALF OF OUR FUNDED
APPLICATIONS HAVE TRADITIONALLY
GONE THROUGH OUR NHGRI-SPECIFIC
REVIEW.
AND SO THAT'S GOING TO BE SORT
OF A CHANGE IN HOW THE REVIEW
IS DONE, HOW WE INTERACT WITH
REVIEW AND A LITTLE BIT IN
TERMS OF WHAT WE EXPECT IN
TERMS OF THE TYPES OF REVIEWS
WE GET, PARTICULARLY DURING
THIS INITIAL TRANSITION PROCESS.
SO THAT'S SOMETHING WE ARE
GOING TO BE WATCHING AND
MONITORING AND MAYBE HAVING
DISCUSSIONS WITH COUNCIL WITH
AS WE SORT OF LOOK AT HOW THE
CSR REVIEW GOES FOR SOME OF OUR
INITIAL INITIATIVES COMING
THROUGH THAT PROCESS.
I WANT TO TAKE A MOMENT TO GIVE
MANY THANKS TO THE FORMER NHGRI
SCIENTIFIC REVIEW BRANCH
MEMBERS.
A NUMBER OF THEM HAVE RETIRED.
A COUPLE OF THEM MOVED TO CSR
AND A COUPLE PEOPLE FROM THAT
BRANCH HAVE TAKEN NEW ROLES AT
NHGRI BUT THEY HAVE ALL BEEN
MAJOR CONTRIBUTORS TO OUR WORK
AND OUR SUCCESS AND OUR
EXTRAMURAL PROGRAM.
I ALSO WANT TO GIVE MANY THANKS
TO THE GENOME G-STANDING
SECTION MEMBERS WHO ARE OUT
THERE.
I GUESS THEY ARE ALL PASSED
NOW, BUT RECENT PASSED, AS WELL
AS PEOPLE WHO PARTICIPATED IN
THE COUNTLESS SAPS SPECIAL
EMPHASIS PANELS THAT NHGRI HAS
PUT TOGETHER FOR REVIEW.
AND OF COURSE THANK YOU TO
EVERYONE WHO HAS SERVED AND
WILL CONTINUE TO SERVE IN THE
FUTURE ON CSR PANELS.
ANOTHER THING TO NOTE, AND I'M
NOT GOING TO BE ABLE TO TALK
ABOUT THIS VERY MUCH BECAUSE
THERE'S ACTIVE LITIGATION, BUT
THERE HAVE BEEN A NUMBER OF
AWARDS TERMINATED BY NIH.
AND YOU CAN GO TO THIS WEBSITE,
THIS TAGGS WEBSITE TO FIND OUT
ABOUT SOME OF THIS.
IF YOU FOLLOW THE LINK THAT
WILL BRING YOU TO A PDF THAT
GETS UPDATED OF ALL TERMINATED
HHS GRANTS.
JUST WANTING PEOPLE TO BE AWARE
OF THAT AS SOMETHING THAT IS
SORT OF HAPPENING IN THE
EXTRAMURAL COMMUNITY THESE DAYS.
SO MOVING FROM NIH TO NHGRI WE
HAVE HAD LEADERSHIP CHANGES,
ERIC GREEN DID NOT HAVE HIS
APPOINTMENT, HE DID NOT GET
REAPPOINTED FOR HIS IC DIRECTOR
TERM YEAR, HE WAS UP FOR
REAPPOINTED AND THE DIDN'T GET
REAPPOINTED AND BONHAM HAS BEEN
MOVED OUT OF HIS LEADERSHIP
POSITION LEADING TO ME BEING IN
THIS ROLE.
WE HAVE SOME GOOD NEWS
LEADERSHIP CHANGES IN OUR
EXTRAMURAL PROGRAM.
SOME OF THIS, ALL OF THIS
HAPPENED PRIOR TO THE HIRING
FREEZE, BUT SINCE OUR LAST
COUNCIL.
SO ERIN RAMOS THE POSITION I
USED TO HOLD, LISA CHADWICK AS
HER DEPUTY.
SIMONA VOLPI FOR DIVISION OF
GENOMIC MEDICINE AND HEATHER
COLLEY PROGRAM DIRECTOR OFFICE
OF DIRECTOR.
I WANT TO THANK THEM FOR
HELPING TO CONTRIBUTE TO THE
LEADERSHIP NEEDED IN THIS TIME
OF SORT OF GREAT CHANGE.
I WILL ALSO TAKE A MOMENT HERE,
THOUGH THEY AREN'T IN
EXTRAMURAL LEADERSHIP TO GIVE A
HUGE THANK YOU TO ELLEN AND JOE
HANKY IN OUR EXECUTIVE OFFICER
AND TEP TI EXECUTIVE OFFICER
WHO HAVE REALLY BEEN CRITICAL
WITH ALL OF OUR STAFF IN
GUIDING US THROUGH THIS TIME.
WE HAVE SOME, ADDITIONALLY WE
HAVE TWO NEW PROGRAM DIRECTORS.
ELENA HERNANDEZ-RAMON IN OFFICE
OF DIRECTOR AND LI ZHANG IN
DIVISION OF GENOMIC MEDICINE.
WE ARE GLAD TO HAVE THEM ON OUR
TEAM AND CONTRIBUTING TO OUR
PROGRAM STAFF AT NHGRI.
WE HAVE ALSO HAD SIGNIFICANT
STAFF LOSSES.
THE EXACT NUMBERS OF THIS, I
CAN'T, ARE TBD.
SOME OF THIS IS ALSO UNDER
ACTIVE LITIGATION.
BUT IF THINGS MOVE FORWARD WITH
THE INTENDED REDUCTIONS IN
FORCE, ALONG WITH OTHER THING
THAT'S HAVE HAPPENED WE EXPECT
TO HAVE 90 FEWER FEDERAL
EMPLOYEES AT NHGRI BY SEPTEMBER.
TO GIVE THAT NUMBER
PERSPECTIVE, THAT'S A LITTLE
OVER 20% REDUCTION IN OUR TOTAL
STAFF.
THAT DOESN'T INCLUDE
CONTRACTORS.
AND WE HAVE ALSO HAD
SIGNIFICANT CONTRACTOR LOSSES.
THE IMPACTED AREAS FOR NHGRI
OUR ENTIRE COMMUNICATIONS GROUP
HAS BEEN, WAS PART OF THE
REDUCTION AND FORCE EFFORT.
SO THAT MAY BE WHY YOU ARE
NOTICING THERE'S SOME CHANGES.
THEY ARE DOING A GREAT JOB WITH
THE VIDEO HERE, BUT IF IT LOOKS
DIFFERENT THAN DIFFERENT
COUNCILS AND OBVIOUSLY
EVERYTHING OUR AMAZING
COMMUNICATION TEAM HAS DONE HAS
BEEN IMPACTED BY THIS.
SIMILARLY, OUR EDUCATION AND
COMMUNITY INVOLVEMENT BRANCH.
OUR POLICY AND PROGRAM ANALYSIS
BRANCH.
ACQUISITIONS AND LOGISTICS AND
OUR MANAGEMENT ANALYSIS AND
WORKFORCE DEVELOPMENT.
BRANCHES WERE ALL IMPACTED BY
THE REDUCTION IN FORCE.
SO I WANT TO THANK EVERYBODY
FROM THOSE GROUPS FOR THE
AMAZING CONTRIBUTIONS THAT THEY
HAVE DONE FOR NHGRI AND IT
SEEMS JUST LIKE EVERY DAY WE
RECOGNIZE SOMETHING THAT USED
TO JUST HAPPEN WITHOUT OUR
THINKING ABOUT IT THAT ISN'T
HAPPENING THE WAY WE EXPECTED
BECAUSE OF THESE LOSSES.
AND WE ARE WORKING.
SO JUST HUGE THANK YOU TO
EVERYBODY FROM THOSE GROUPS FOR
EVERYTHING YOU HAVE DONE FOR
NHGRI OVER YOUR TIME.
WE ALSO WERE HIGHLY IMPACTED IN
GRANTS MANAGEMENT.
THIS WAS STARRED OUT BECAUSE IT
WASN'T AN AREA TARGETED AND
MORE IMPACTED BY SOME OF THE
VOLUNTARY RETIREMENT OFFERS
THAT WERE PUT FORWARD.
AND SO, BUT WE FEEL THAT VERY
ACUTELY, SIMILAR TO THE LOSS WE
FEEL IN THESE OTHER IMPACTED
AREAS, SO I WANTED TO CALL THAT
OUT.
DESPITE THIS, YOU KNOW, WE
STILL HAVE AN EYE ON THE NHGRI
STRATEGIC VISION.
WE HAVE TO UPDATE SOME ASPECTS
OF OUR IMPLEMENTATION OF THIS
TO ENSURE ALIGNMENT WITH NEW
HHS AND NIH PRIORITIES BUT THE
UNDERLYING MISSION IS THE SAME.
NAMELY AS LEADING AUTHORITY IN
THE FIELD OF GENOMICS OUR
MISSION IS TO ACCELERATE
SCIENTIFIC AND MEDICAL BREAK
THREWS THAT IMPROVE HUMAN
HEALTH.
WE WILL CONTINUE TO DO THIS BY
DRIVING CUTTING EDGE RESEARCH,
DEVELOPING NEW TECHNOLOGIES AND
STUDYING THE IMPACT OF GENOMICS
ON SOCIETY.
WE WANT TO COLLABORATE AND WORK
WITH THE LARGER SCIENTIFIC AND
MEDICAL COMMUNITIES TO ENHANCE
GENOMIC TECHNOLOGIES THAT
ACCELERATE BREAK THREWS AND
IMPROVE LIVES AND ADVANCE THE
FOREFRONT OF GENOMICS.
I'M JUST GOING TO GIVE A COUPLE
HIGHLIGHTS TO SHOW SOME OF THE
ACTIVITY WE HAVE BEEN DOING
SINCE LAST COUNCIL.
SO IN THE EXTRA MURAL RESEARCH
SIDE, OUR OFFICE OF GENOMIC
DATA SCIENCE HOSTED A WORKSHOP
IMPROVING THE FAIRNESS AND
SUSTAINABILITY OF THE NHGRI
RESOURCES ECOSYSTEM IN MARCH.
THE GOALS OF THE WORKSHOP WERE
DEVELOPED ACTUAL
RECOMMENDATIONS AT THE NHGRI
FUNDED RESOURCE COMMUNITY CAN
ADOPT TO IMPROVE THE FAIRNESS
AND SUSTAINABILITY OF OUR
RESOURCES, ENHANCING THEIR
DISCOVERABILITY, ACCESSIBILITY,
QUALITY AND UTILITY.
WORKSHOP TOPICS WERE
PRIORITIZED BASED ON RESULTS OF
THE SELF-ASSESSMENT PERFORMED,
WE PERFORMED WHICH FOCUSED ON
THE RESOURCES ONGOING PRACTICES
TO IMPLEMENT THE FAIR
PRINCIPLES AND THEIR EFFECTIVE
IMPROVEMENT PLANS.
THESE ARE BEING COMPILED INTO A
REPORT THAT WILL BE RELEASED IN
ZENOTO.
SIMILARLY, THE MOLECULAR
PHENOTYPES ANALYSIS OF CELLS OR
MORPHIC CONSORTIUM IS
DEVELOPING AN EXTENSIVE CATALOG
OF MOLECULAR AND PHENOTYPE A
LILLES OF EVERY HUMAN GENOME,
CONSORTIUM'S MARKER PAPER WAS
PUBLISHED IN NATURE THIS PAST
FEBRUARY.
AND IT ALSO CORRESPONDED WITH
THE FIRST RELEASE OF THE DATA
CATALOG WHICH COULD BE ACCESSED
THROUGH THE CONSORTIUM'S
WEBSITE.
AND FINALLY, I WILL HIGHLIGHT
THIS PAST DECEMBER, NHGRI'S
GENOMIC MEDICINE WORKING GROUP
JOINED WITH NIAID TO HOLD A
16th GENOMIC MEDICINE WITH HOST
GENOMICS AND INFECTIOUS
DISEASES.
SCIENTISTS CONVENED TO REVIEW
RESEARCH OPPORTUNITIES FOR
INCREASING USE OF GENOMIC DATA
IN THE CLINICAL CARE OF INFECK
SHUSING DISEASES.
GENOMIC APPROACHES FOR
IMPROVING IDENTIFICATIONS OF
INDIVIDUALS WITH AIRBORNE
IMMUNITY AND INFECTIOUS DISEASE
COMPONENTS INTO CONSORTIA.
OBVIOUSLY I COULD IDENTIFY
ADDITIONAL WORK THROUGH OUR
CONSORTIA AND ACTIVITIES BUT
WITH OUR LIMITED STAFF, YOU ARE
GOING TO GET MORE LIMITED
HIGHLIGHTS IN TERMS OF THE
ACTIVITIES THAT WE ARE DOING.
I WILL ALSO CALL OUT AND I HAVE
THIS READY BECAUSE THIS WAS
GOING TO BE PREPARED, THIS WAS
PREPARED FOR THE FEBRUARY
COUNCIL, SOME
INVESTIGATOR-INITIATED
HIGHLIGHTS OF WORK FROM OUR
EXTRAMURAL FUNDED INVESTIGATORS.
SO FIRST WE HAVE A PUBLICATION
BY BEI LIU AND COLLEAGUES,
SNORNA FACILITATED PROTEIN
SECRETION REVEAL BID TRANSCRIPT
TOME WIDE SNORNA TARGET
IDENTIFICATION.
GU AND COLLEAGUES WITH A CRISPR
SCREENING METHOD READ OUT IN
CELL TYPES AND CONTEXT ELUSIVE
IN OPTICAL SCREENING.
THEY DEMONSTRATED OPTICAL
PHENOTYPE PINPOINTS LIKELY
PATHOGENIC DERIVED MUTATIONS,
PREVIOUSLY CLASSIFIED OF
UNKNOWN CLINICAL SIGNIFICANCE.
LASTLY IN THIS PAPER BY WANG
AND COLLEAGUE RESEARCHERS
DESCRIBED A NEW METHOD
PROGRESSION SCORE BY
INTEGRATING DATA FROM EHR BASED
BIO BANKS AND CONTROL STUDIES
ABLE TO DERIVE RELIABLE RISK
SCORES FOR THE PROGRESSION OF
RHEUMATOID ARTHRITIS AND LUPUS.
AGAIN, JUST A SMALL SUBSET OF
HIGHLIGHTS OF THE IMPORTANT
WORK THAT ALL OF OUR EXTRAMURAL
RESEARCHERS ARE DOING.
THE INTRAMURAL SIDE WE ALSO
CONTINUE TO HAVE SOME
CHALLENGES UNIQUE TO BEING IN
AN INTRAMURAL RESEARCH PROGRAM
AT NIH THESE DAYS BUT ALSO
CONTINUE TO MOVE FORWARD WITH
SOME EXCITING RESEARCH.
CHARLES PUBLISHED A PAPER
WITHIN THE LAST COUPLE WEEKS
FOCUSED ON SUB CONTINENTAL
GENETIC VARIATION IN THE ALL OF
US RESEARCH PROGRAM AND FOUND
THAT SELF-IDENTIFIED RACE AND
ETHNICITY CATEGORIES DO NOT
ALIGN NEATLY WITH GENETIC
VARIATION.
THEY NOTED THAT THESE
DISTINCTIONS IMPACT TRAITS LIKE
BMI AND HEIGHT WHICH ARE
CRUCIAL FOR REDUCING
CONFOUNDING GENETIC ASSOCIATION.
THIS REALLY IS STRONG ALIGNMENT
WITH THE NATIONAL ACADEMIES
REPORT CALL FOR MORE PRECISE
AND CONTEXT SPECIFIC
DESCRIPTORS PREVIOUSLY PRESENT
TODAY THIS COUNCIL.
PHIL PRESENTED COMPARATIVE
ANALYSIS FOR SIX APE SPECIES,
HIGHLY REPETITIVE GENOMIC
REGIONS.
AND ENABLING BETTER COMPARISONS
ACROSS SPECIES.
THIS WAS ABLE TO SHED NEW LIGHT
ON APE GENOME EVOLUTION AND
PROVIDE FOUNDATIONAL RESOURCE
FOR UNDERSTANDING HUMAN
EVOLUTIONARY HISTORY.
MEHRU FOUND CAN MUTATE WITHOUT
HINDERING PRODUCTION.
EMPHASIZING THE IMPORTANT
THINGS THAT COULD BE FOUND
THROUGH DESIGN OF SYNTHETIC
PROTEINS.
AND FINALLY JULIE SEGRE AND
COLLEAGUES FOUND THE SKIN
SERVES AS KEY RESERVOIR FOR
BACTERIA IN NURSING HOMES AND
CONTRIBUTES TO THE SPREAD
WITHIN FACILITIES SO THIS
HIGHLIGHTS THE IMPORTANCE OF
CONSIDERING THE SKIN RESERVOIR
WHEN CONSIDERING BOTH TRACKING
AND ADDRESSING POTENTIAL
INFECTION PREVENTION METHODS IN
THOSE SETTINGS.
SO AGAIN, MANY MORE HIGHLIGHTS
COULD HAVE BEEN BROUGHT FORWARD
FROM OUR INTRA AND EXTRAMURAL
PROGRAMS BUT I WANT TO SHOW
THIS TO SHOW HOW SCIENCE IS
CONTINUING TO MOVE FORWARD IN
THESE TIMES.
I WILL JUST SAY THERE'S A LOT
HAPPENING AT NHGRI TODAY.
AT ONE POINT I WAS SUPPOSED TO
BE THREE PLACES AT ONCE.
OUR CLINICAL FELLOWS ARE HAVING
THEIR GRADUATION.
I WAS ABLE TO PROVIDE TAPED
REMARKS FOR THEM AND SOME
EXCITING ACTIVITIES AND I JUST
WANT TO SAY CONGRATULATIONS TO
THOSE GRADUATES.
WE ARE SAVING OUR QUADRENNIAL
REVIEW SITE VISIT.
THEY UNDERGO A REVIEW FROM THE
PREVIOUS FOUR YEARS AS WELL AS
PLANS FOR THE NEXT FOUR YEARS
THIS IS VITAL FOR MAINTAINING
HIGH STANDARDS OF EXCELLENCE IN
THE PROGRAM AND MAKING
DECISIONS ABOUT FUTURE RESEARCH
ALLOCATIONS.
SO I WANT TO THANK, I THANK
THEM IN PERSON BUT THAT'S WHERE
I WAS THIS MORNING TO THE
PEOPLE PARTICIPATING IN THAT
QUADRENNIAL REVIEW.
I'M GOING TO JUST HIGHLIGHT
THAT WE HAVE A REALLY GREAT
OPEN SESSION.
WE WILL HAVE A T32 EVALUATION
REPORT, THREE CRITICAL CONCEPT
CLEARANCES.
THERE WILL BE SOME REPORTS READ
INTO THE MINUTES AS WELL AS
COUNCIL BUSINESS THAT JEN
TROYER WILL HANDLE AT THE END.
I WANT TO GIVE A HUGE THANK
YOU, CALLING OUT PARTICULARLY
OUR COUNCIL EXECUTIVE JEN
TROYER, OUR COUNCIL
COORDINATOR, ISSEL LIM, COMFORT
BROWN, OUR COUNCIL CONFLICT OF
INTEREST MANAGER, NICK NGUYEN.
AS WELL AS IT SUPPORT STAFF,
NIH VIDEO SUPPORT STAFF ARE
HAVING AND ALL OF THE PEOPLE
LISTED HERE WHO HAVE
CONTRIBUTED EITHER TO MAKING
THIS DAY A SUCCESS OR MAKING MY
SLIDE PRESENTATION.
SO WITH THAT, I WILL STOP AND
TURN IT OVER TO SEE IF THERE
ARE ANY QUESTIONS.
I'M GIVING COUNCILMEMBERS A FEW
SECONDS TO RAISE THEIR HANDS IF
THEY WANT TO ASK ANYTHING.
OKAY, I THINK WE ARE MOVING
ONTO CHRIS GUNTER'S
PRESENTATION.
THIS WAS ALSO PLANNED FOR OUR
FEBRUARY COUNCIL WHICH WE HAD
TO CANCEL.
WELCOME CHRIS AND LOOK FORWARD
TO YOUR PRESENTATION.
>> MAKING SURE I CAN TURN THAT
ON.
THANK YOU SO MUCH FOR HAVING ME
HERE.
I WILL WALK YOU THROUGH OUR
EVALUATION, FIRST ABOUT WHY WE
DID IT AND TELL YOU WHAT WE DID.
IN PARTICULAR WE LOOKED AT THIS
GRANT WITH A VERY LONG NAME
THAT RUTH, A FORMER DIRECTOR OF
NIH, HER NRSA INSTITUTIONAL
TRAINING GRANTS, THE T32 IS
WHAT WE CALL IT FOR SHORT SO
THAT'S WHAT I WILL CALL IT
THROUGHOUT THIS PRESENTATION.
THIS WAS ONLY POSSIBLE WITH THE
HELP OF MY COLLEAGUE MOLLY BIRD
WHO IS TUNING IN AND ABLE TO
ANSWER QUESTIONS AS WELL.
THANK YOU VERY MUCH.
AND WE ALSO WORKED WITH A
NUMBER OF TRAINING STAFF AS I
WILL TELL YOU THROUGHOUT, SO
THANK YOU TO THEM AS WELL.
I WILL TELL YOU ABOUT OUR
EVALUATION QUESTIONS AND
METHODS AND TELL YOU OUR
FINDINGS THROUGH A NUMBER OF
DIFFERENT METHODS AND HOW WE
DID THOSE.
BUT FIRST YOU MIGHT BE ASKING
YOURSELF WHY ARE WE DOING THIS?
WHY WE ESTABLISHED THIS FORMER
EVALUATION CAPABILITY AT NHGRI.
AS PART OF THE U.S. GOVERNMENT
WE ARE REQUIRED BY SOMETHING
CALLED THE EVIDENCE ACT OF 2018
TO ACTUALLY SHOW THE EVIDENCE
FOR OUR DECISION MAKING
PROCESSES.
AND THE WAY THE NIH AND ITS
PARENT AGENCY, HHS HAVE
DEVELOPED A RESPONSE TO THAT IS
TO DEVELOP FRAMEWORKS LIKE THIS
FOR EVALUATION AND TRANSPARENCY
AND INNOVATION AND RESPONSE.
AND THAT INCLUDES A REQUEST
THAT WE ALL RECEIVED AT OUR
INSTITUTES TO CARRY OUT MORE
IN-DEPTH EVALUATIONS AND SHARE
THE DATA FROM THOSE.
YOU MIGHT REMEMBER THAT WE CAME
TO THIS COUNCIL LAST YEAR IN
FEBRUARY AND TALKED TO YOU
ABOUT OUR FIRST LARGE
EVALUATION WHICH WAS THE
CENTERS OF EXCELLENCE IN
GENOMIC SCIENCES OR CEGS, THAT
IS AVAILABLE ON OUR WEBSITE NOW.
WE THEN WANTED TO TURN IT TO
TRAINING WHICH HAS BEEN A
PRIORITY FOR NHGRI BUT ALSO FOR
THIS COUNCIL IN PARTICULAR.
SO WE DECIDED TO LOOK AT THIS
INSTITUTIONAL AWARD INSTEAD OF
INDIVIDUAL AWARDS AS A PROGRAM.
THE NHGRI NOW FUNDS T32'S IN
THREE DIFFERENT SUBJECT AREAS.
IF YOU HAVE BEEN A LONG TERM
WATCHER OF COUNCIL YOU WILL BE
FAMILIAR, THE FIRST IS ETHICAL,
LEGAL AND SOCIAL IMPLICATIONS
OR ELSI.
THESE ARE 2024 MAPS OF THE U.S.
ALSO SIX PROGRAM FOR GENOMIC
MEDICINE AND 12 FOR GENOMIC
SCIENCE AS OF THIS YEAR.
SINCE THE PROJECT STARTED WE
HAVE OVER 2,000 PREDOCTORAL AND
POSTDOCTORAL TRAINEES AND 23
GRANTS TO 17 INSTITUTIONS.
THIS IS NOT A SMALL COMMITMENT
ON BEHALF OF NHGRI OR NHL.
LOOKING AT OUR EVALUATION
METHODS AND QUESTIONS.
A MODEL, THE IMPORTANT PARTS
ARE IN THE COLORED SECTIONS.
SO THE PURPLE HERE IS THE
INPUTS, WE CHARACTERIZE WHAT WE
AND OUR PARTNERS ACTUALLY
INVESTED IN THESE PROGRAMS.
THE BLUE SECTIONS ARE THE
OUTPUTS WHAT ACTIVITIES AND
WHAT MEASURES ARE WE GOING TO
USE TO LOOK AT THOSE BUT MORE
SPECIFICALLY WE WILL FOCUS ON
THE GREEN SECTIONS, OUTCOMES.
THE SHORT-TERM, DURING
TRAINING, MEDIUM AFTER TRAINING
AND LONG TERM IMPACT OR LEGACY
OF THIS PROGRAM.
WE BOIL THOSE DOWN INTO THREE
EVALUATION QUESTIONS.
SO THE FIRST ONE WHAT HAS BEEN
THE IMPACT OF THE FUNDING.
BASICALLY WHAT DID WE GET FOR
OUR MONEY IN TRAINING OUTCOMES.
HAS THIS FUNDED AND ACCELERATED
AREAS CENTRAL TO THE STRATEGIC
VISION AND PRIORITY AREAS OF
NHGRI.
AND THIRD WHAT ARE THE
COMMUNITY'S PERCEPTIONS OF THE
PROGRAM AND DO THEY HAVE
SUGGESTIONS FOR IMPROVEMENT?
WE ARE COMMITTED TO MAKING SURE
WE CAN DO THIS AS BEST WE CAN.
WE CHOSE THREE DIFFERENT
METHODS.
WE DID TRACKING OF TRAINEES.
I WILL WALK YOU THROUGH THAT.
A SURVEY OF TRAINEES WE ASKED
THEM AND DID QUALITATIVE
INTERVIEWING.
AND THAT BASICALLY GIVES US A
DIAGRAM OF CONCENTRIC CIRCLES
HOW WE REACHED OUT TO CURRENT
AND FORMER TRAINEES.
TO WALK THROUGH THOSE FIRST
WHEN WE LOOKED AT TRACKING
DATA, RIPPLE EFFECT, SO THANK
YOU TO THEM.
SINCE OUR FIRST TRAINING GRANT
IN 1990.
WE WENT THROUGH DEMOGRAPHICS,
LOOKED AT PUBLICATIONS
ACKNOWLEDGING THE T32 GRANT AND
PUBLICATIONS THAT WERE PRODUCED
DURING AND AFTER TRAINEES
WORKED ON THE PROGRAM AND
SUBSEQUENT NIH GRANT
SUBMISSIONS AND AWARDS FOR
THOSE.
SECOND, WE THEN DECIDED TO ASK
THE TRAINEES THEMSELVES.
SO WE DID A SURVEY.
WE BOILED THIS DOWN TO
CONCENTRIC CIRCLES, THIS
REPRESENTS A LOT OF WORK OF
AMBER JACKSON AND MOLLY BIRD SO
THANK YOU TO THEM.
WE LOOKED AT PROGRESS REPORTS
AND TRIED TO FIND AS MANY EMAIL
ADDRESSES WE ENDED UP WITH SET
OF 1,283 FOR TRAINEES.
WE SENT AN EMAIL, WE FOUND ONLY
1,045 WERE VALID.
AND WE GOT BACK 447 RESPONSES.
A GOOD RESPONSE RATE OF 40% OF
THAT.
ON OUR SURVEY WE ASKED
QUANTITATIVE AND OPEN-ENDED
ITEMS WE DEVELOPED WITH THE
P.I.'S IN ADVANCE.
THEY WANTED US TO ASK ARE YOU
HAPPY AND ARE YOU USING WHAT
YOU LEARNED IN YOUR T32 TIME?
SO WE INCORPORATED BOTH OF
THOSE.
WE ALSO HAD DEMOGRAPHIC
INFORMATION, ABOUT THAT I WILL
SAY THE TWO FINAL SETS WERE
PRETTY SIMILAR IN DEMOGRAPHICS.
AND FINALLY WE DID QUALITATIVE
INTERVIEWS.
WE CO CREATED AN INTERVIEW
GUIDE WITH THE TRAINING TEAM
AND SEMI STRUCTURED INTERVIEWS
WITH 34 P.I.'S, TWO REVIEWERS
OFFERED MULTIPLE ROUNDS AND
GREAT SUGGESTIONS AND SEVERAL
STAFF MEMBERS.
WE CODED FOR IMPORTANT THEMES
AND WE DID A LOT OF FEEDBACK
ROUNDS.
THIS IS THE LAST FEEDBACK ROUND
FOR COUNCIL, WE WILL WELCOME
YOU COULD FIND ME ON THE
WEBSITE AND THEN TALK TO A
NUMBER OF PEOPLE AND THAT WAS
VERY VALUABLE HELPING US TO THE
FINAL PRODUCT.
WHERE DID OUR TRAINEES GO AND
WHERE ARE THEY NOW?
IF YOU LOOK AT THE LARGER POOL
ON THE RIGHT, YOU COULD SEE
THOSE ARE ALL TRAINEES AND THE
COLUMN ON THE LEFT IS THE
SURVEY RESPONDENTS.
SO WE FOUND THAT A NUMBER OF,
THIS IS PREDOCTORAL VERSUS
POSTDOCTORAL, THE FIRST NUMBER.
THE GENOMIC SCIENCES
REPRESENTED SLIGHTLY, THANK YOU
TO THOSE WHO ANSWERED THE
SURVEY A LITTLE MORE.
AND RECENCY BIAS WHICH IS
FAIRLY COMMON WITH SURVEYS.
THOSE WHO ANSWERED WERE MORE
RECENT THAN THOSE WHO HAD BEEN
IN THE PAST.
THIS MAP IS SHOWING THE
LOCATIONS OF THE T32 TRAINING
SITES.
THOSE ARE THE BLUE DOTS.
THAT'S WHERE OUR TRAINING SITES
ARE.
AND WE ASKED THE TRAINEES WHERE
THEY WERE AFTER THE GRANT.
AND YOU COULD SEE WE FEEL THIS
IS MEETING THEIR RUTH GRANT, OR
STATEMENT LISTED IN THEREOF
SUPPLYING A TRAINED BIOMEDICAL
WORKFORCE ACROSS THE ENTIRE U.S.
WE HAVE TRAINEES IN ALMOST
EVERY STATE IN THE COUNTRY.
LOOKING AT OUR TRACKING DATA.
WE FOUND OUR TRAINEES AUTHORED
3,303 PUBLICATIONS
ACKNOWLEDGING THE GRANTS.
THIS IS A CHANCE TO GIVE A
PLEA, PLEASE MAKE SURE YOU
ACKNOWLEDGE YOUR GRANT IN YOUR
PUBLICATION BECAUSE THAT'S HOW
WE PRODUCE GRAPHS LIKE THIS.
THANK YOU VERY MUCH TO THEM.
WHEN WE LOOKED AT CITATIONS WE
FOUND THE PUBLICATION THAT
ACKNOWLEDGE WERE HIGHLY CITED.
BOTTOM LEFT IS MEASURE R.C.R.
DEVELOPED BY THE NIH.
NORMALIZES THE RELATIVE
CITATIONS IN THE FIELD, THE
AVERAGE WOULD BE ONE.
THE MEAN IN THESE PUBLICATIONS
IS 3.7.
THAT MEANS 3.7 MORE HIGHLY
CITED THAN THE AVERAGE.
TWO CITED MORE THAN 5,000 TIMES
SO THEY ARE BEING CITED.
ALSO THE TRAINEES PRODUCED
HIGHLY INFLUENTIAL PAPERS AFTER
THEIR TIME IN THE PROGRAM.
EACH CITED OVER 11,000 TIMES.
YOU COULD SEE THE HIGHEST,
CYTOSCAPE OVER 40,000 TIMES.
I WILL SHOW YOU TWO DIFFERENT
WAYS TO LOOK AT GRANTS.
FIRST IS FROM THE APPLICATION
PERSPECTIVE.
THAT IS THAT THE T32 TRAINEES
SUB SY QUENT APPLICATIONS HAD A
24% AWARD RATE FOR ANY TYPE ONE
ACROSS NIH AND 17% FOR R01.
THIS IS THEIR APPLICATIONS.
AS CAROLYN MENTIONED ONE OF THE
THINGS NHGRI HAS IN ITS
STRATEGIC VISION WE ARE IN THE
FOREFRONT OF GENOMICS, WE
DEVELOP TECHNOLOGY AND
INNOVATIONS AND WITH WANT THAT
SPREAD OUT ACROSS THE REST OF
BIOMEDICAL RESEARCH AND WE SEE
THAT SUPPORTED IN THE DATA.
THE SUBSEQUENT FUNDING IS BEING
SPREAD OUT ACROSS MULTIPLE
INSTITUTE AND CENTERS FOR NIH.
WE SWITCHED THE PEOPLE
PERSPECTIVE OF THE ALMOST 600
TRAINEES THAT APPLY FOR TYPE 1
FUNDING.
62% FUNDING RATE.
WE SAW SIMILAR FUNDING RATES
WHETHER PREDOCTORAL OR
POSTDOCTORAL TRAINEE.
AROUND THE SAME THING.
AND TURNING TO OUR SURVEY.
WE SAW THAT THE TRAINEES WHO
RESPONDED TO THE SURVEY WERE
LARGELY IN RESEARCH ROLES IN
ACADEMIA OR INDUSTRY.
MORE LIKELY IN T32'S AND ASKED
THE QUESTION PI'S WANTED US TO
ASK, ARE YOU HAPPY?
IF THEY WERE SATISFIED WITH
THEIR CAREER TRAJECTORY.
VERY SATISFIED THAT WAS THE
MAJORITY OF TRAINEES WHO SAID
THAT.
ASKED THEM IF THEY WOULD USE
THE SKILL ORZ KNOWLEDGE OR WERE
USING THE SKILLS OR KNOWLEDGE
THEY GAINED DURING THEIR
EXPERIENCE.
ONLY 3% SAID NO.
EVERYONE ELSE SAID YES.
THIS IS A QUOTE FROM ONE, THEY
DIDN'T HAVE SKILLS AND NOW THEY
ARE USING THEM EVERY DAY.
WE SPECIFICALLY ASKED THEM HOW
THEY WERE PREPARED FOR THEIR
CURRENT OR FUTURE ROLE.
MOST SAID SKILLS DEVELOPMENT.
ON THE RIGHT YOU COULD SEE SOME
OF THE SPECIFIC SKILLS THEY
MENTIONED.
ALL THE THINGS YOU WOULD EXPECT
FOR A SCIENTIFIC CAREER.
AND FINALLY WE ASKED THEM FOR
SUGGESTIONS OF IMPROVEMENT,
WHAT DO THE TRAINEES THINK WE
COULD BE DOING BETTER THEY
SUGGESTED MORE EXPOSURE TO NON
TRADITIONAL CAREERS, ELSI
PROGRAMS AND AI AND MACHINE
LEARNING.
THOSE ARE THINGS YOU PROBABLY
COULD HAVE PREDICTED IN ADVANCE.
I WILL END WITH A QUALITATIVE
DATA SUMMARY.
WE INTERVIEWED ALL 34 P.I.'S
AND TWO REVIEWERS.
WE DIDN'T ASK QUESTIONS OF THE
BUDGET AND THAT CAME UP IN
EVERY INTERVIEW AS YOU COULD
IMAGINE.
WE ASKED WHAT DO YOU SEE AS
YOUR TOP SUCCESSFUL OUTCOME.
WORKFORCE DEVELOPMENT.
SECOND COMMUNITY, BUILDING
COMMUNITY AND THIRD WAS ADVANCE
ISING NHGRI STRATEGIC VISION.
THEN ASKED THEM HOW THIS GRANT
ALLOWED YOU TO PROVIDE TRAINING
THAT WOULDN'T HAVE OTHERWISE
BEEN POSSIBLE.
THE TWO TOP THEMES WERE
STRUCTURE AND RESOURCES.
YOU COULD SEE QUOTES FROM PI'S
GIVING EXAMPLES HOW THEY WERE
ABLE TO DEVELOP OTHER PROGRAMS
OR OTHER COURSES.
AND THE SECOND WAS ATTRACTING
TOP TALENT PARTICULARLY FOR
MD'S.
THAT WAS THE MOST IMPORTANT FOR
US IS TO ATTRACT MD'S AND ALLOW
THEM TO PAUSE THEIR CLINICAL
CAREERS TO DO THIS RESEARCH,
THIS CLINICAL RESEARCH.
SO TWO THEMES WE DIDN'T ASK
THAT CAME UP.
I SHOULD POINT OUT BOTH, NUMBER
OF THESE ARE AT THE NIH LEVEL
AND NOT THE NHGRI LEVEL.
THE FIRST ONE WAS SALARY
DISCREPANCIES BETWEEN TRAINEES
AND UNIVERSITY REQUIREMENTS ARE
A PROBLEM AND THAT AFFECTS
PARTICIPATION.
THAT WAS BROKEN INTO TWO AREAS
FOR TRAINEES NOT BEING ABLE TO
BE ON THE GRANT AND FACULTY NOT
HAVING TRAINEES ON THE GRANT
BECAUSE THEY COULDN'T MAKE UP
THE DIFFERENCE WHAT WAS
SUPPLIED BY THE GRANT AND WHAT
INSTITUTIONAL REQUIREMENTS WERE.
THAT'S SOMETHING AT THE NIH
LEVEL.
THE SECOND THEME WAS PROGRAM
ADMINISTRATOR AND MANAGERS ARE
IMPORTANT TO THESE GRANTS BUT
NEED MORE SUPPORT.
THAT BROKE UP INTO THREE AREAS
PEOPLE OVER LOADED AND STRESSED
WE CAN PROBABLY ALL RELATE TO,
NOTEN VIETED OR COVERED BY THE
INDO MEETING OR NOT
SUFFICIENTLY SUPPORTED BY
FUNDS, A THE NIH LEVEL.
AND I WILL END WITH SOME QUOTE
THAT'S SPEAK FOR THEMSELVES
THIS WAS ABOUT THE TRAINEE
TRACKING TABLES.
ONE TOLD US, THEY WENT FROM A
POINT YOU WANT TO RIP YOUR EYES
OUT AND JUMP OUT A WINDOW TO
JUST WANTING TO STAB YOURSELF
IN THE HEAD WITH AN ICE PICK.
I HAVE TO NOTE NIH PUT
SIGNIFICANT CHANGES TO THIS
APPLICATION REVIEW AND
REPORTING PROCESS IN PLACE IN
JANUARY 2025, WE HAVEN'T GONE
BACK AND ASKED FOR ANOTHER
ANALOGY YET BUT HOPEFULLY IT'S
BETTER FOR THEM.
JUST TO SUM UP, OUR EVALUATION
QUESTIONS WE ASKED WHAT THE
IMPACT WAS ON OUTCOMES, THEY
ARE SATISFIED WITH THEIR
CAREERS USING SKILLS THEY
LEARNED.
THEY PUBLISHED HILI CITED
PAPERS, RECEIVED GRANTS AND NOW
STRUCTURE T32 PI.
WE ASKED HAS THIS SUPPORTED
ACCELERATED AREA CENTRAL TO OUR
VISION?
WE HAVE SEEN PAPERS, GRANTS AND
AWARDS, SPREAD ACROSS OTHER
IC'S WHICH IS PART OF OUR
VISION, WE SAW THE TRAINEES
SPREAD ACROSS THE U.S. ONE
QUESTION I DIDN'T COVER, WE
ASKED ALL PI'S DID YOU FEEL
THIS GRANT FOSTERED
INTERDISCIPLINE AIRITY AND
EVERY SINGLE PI ANSWERED YES TO
THAT QUESTION.
FINALLY WE ASKED WHAT DO YOU
ALL THINK ABOUT THIS?
DO YOU HAVE SUGGESTIONS FOR
IMPROVEMENT, WE GOT QUITE A FEW.
THEY SAID THE PROGRAM WAS A
SUCCESS, PARTICULARLY NUMBER
TALKED ABOUT OUR ANNUAL MEETING
BEING AN IMPORTANT PART OF THE
PROGRAM.
THEY HAVE ONGOING CONCERNS
ABOUT THE APPLICATION, BUDGET
STRUCTURE, MANY OF THOSE AT THE
NIH LEVEL, NOT THE NHRI LEVEL.
BUT PLAN GOING FORWARD LIKE FOR
CEGS PUBLISH THIS ON A REPORT
WHICH WILL LOOK LESS NICE
BECAUSE WE DON'T HAVE THE COMMS
TEAM BUT WE PLAN TO PUT IT ON
THE WEBSITE AND PUBLICATION.
THANK YOU TO THE RIPPLE EFFECT
TEAM.
MOLLIE BIRD WAS A CRUCIAL PART
AND DID A LOT OF THE WORK.
EVERYONE WHO PARTICIPATED AND I
WILL TAKE ANY QUESTIONS.
P BRUCE?
>> THANK YOU.
ONE THING THAT STRIKES ME THE
WORLD THE TRAINEES ARE ENTERING
INTO IS ALREADY QUITE DIFFERENT
FROM THE ONE THAT EXISTED EVEN
A FEW MONTHS AGO.
AND I WONDER, IT'S PROBABLY TOO
RECENT TO SHOW UP ON THE DATA
COLLECTION.
BUT I WONDER IF THERE'S SOME
WAY OF TRACKING WHETHER THERE'S
BEEN AN IMPACT OF RECRUITMENT
OF TRAINEES TO THE PROGRAMS ON
ONE HAND OR OUTCOMES IN TERMS
OF A ABILITY TO FIND RESEARCH
POSITIONS GIVEN THE CHANGES WE
HEARD ABOUT EARLIER IN TERMS OF
FUNDING.
>> I THINK THAT'S A GREAT
QUESTION.
I THINK WE ALL EXPECT WE WOULD
SEE THAT.
I ALSO RUN AN INTRAMURAL LAB
WHICH IS HOW WE WERE ABLE TO DO
THIS STUDY.
I'M LOOKING FOR POST VAKS IF
ANYONE WOULD LIKE TO JOIN, WHO
IS WATCHING, AND CHART THOSE I
WOULD BE HAPPY TO HAVE YOU IN
THE LAB.
I THINK WE ARE ALL INTERESTED
IN THE ANSWERS TOO.
>> I KNOW WHAT ERIC WAS WANTING
AND HIS VISION, WHICH I WILL
CERTAINLY KEEP MOVING FORWARD
AND HOPEFULLY WHOEVER COMES ON
AS THE NEXT PERMANENT ONE IS
HAVING SOME OF THESE DIFFERENT
THINGS THAT CHRIS IS DOING CAN
ALSO SERVE AS BENCHMARKS, RIGHT?
IT'S ACTUALLY KIND OF USEFUL TO
THINK WE HAVE THE TIMING THAT
WE HAVE 2024, WHICH IS WHEN
THIS WAS PRIMARILY DONE,
BENCHMARK AND HAVING THAT
ABILITY TO DO SOME OF THAT
FOLLOW-UP WILL BE UNAIDED BY
HAVING HAD THIS.
THIS ALL PREDATED THAT IN TERMS
OF TIMING.
THIS WAS SUPPOSED TO HAVE BEEN
A PRESENTATION AT FEBRUARY
COUNCIL.
BUT I THINK IT WILL SERVE AS
HELPFUL TO UNDERSTAND IS SOME
OF THOSE THINGS AND HOW WE
MIGHT ADDRESS THEM.
>> I SAW JUDY'S HAND UP AND
THEN KELLY.
>> OKAY, I WILL GO FIRST THEN.
I WANT TO JUST AMPLIFY ON TWO
POINTS THAT YOU MADE THAT I
COULDN'T AGREE WITH MORE.
ONE WAS THE VALUE TO LATE
BLOOMERS LIKE MYSELF.
WHO BASICALLY DIDN'T DECIDE
UNTIL AFTER INTERNAL MEDICINE
RESIDENCY I WANTED TO DO
RESEARCH.
SO I DO THINK THIS IS
ABSOLUTELY ESSENTIAL, THAT NOT
ALL MD RESEARCHERS OR MD
Ph.D.'S ARE ESSENTIAL TO MAKING
LATE BLOOMING PHYSICIAN
SCIENTISTS HAVE A VIABLE CAREER
IN RESEARCH.
KUDOS TO THAT AND I REALLY
AMPLIFY THAT POINT.
THE SECOND ONE IS THAT FINAL,
IT'S A SMALL POINT ABOUT THE
ORCHID THING.
INCREASINGLY JOURNALS ARE USING
ORCHID AND NOW FOR ALL MY PAPER
SUBMISSIONS AND REVIEWS, THE
ORCHID IS THE WAY TO GO.
SO SOME OF THE CHANGES WITH
RESPECT TO WOMEN WITH THEIR
MAIDEN NAME AND MARRIED NAME.
I DO THINK ORCHID IS YOUR
SCIENTIFIC SOCIAL SECURITY
NUMBER.
I WOULD ENCOURAGE USE OF THAT
THROUGHOUT.
>> GREAT POINT, WE PRESENTED
THIS WORK TO THE EVALUATION
ACROSS THE NIH AND THEY ALSO
AGREED WITH THAT.
WE WILL KEEP TRYING TO WORK
WITH ALL OF THEM TO MAKE THAT,
GO TO THE RIGHT PLACE, THAT
SUGGESTION.
>> CAROLYN: KELLY, GO AHEAD.
>> KELLY: SO ONE OF THE POINTS
YOU HAD IS THAT THE TRAINEES
THEMSELVES HAD REQUESTED
GREATER EXPOSURE TO
NON-TRADITIONAL CAREER PATHS.
I WOULD ALMOST SAY THAT THAT'S
A CODE WORD FOR INDUSTRY.
I THINK THE MAJORITY OF OUR
TRAINEES ARE GOING TO INDUSTRY
AND THAT'S BECAUSE THERE'S MORE
JOBS IN INDUSTRY THAN THERE ARE
IN ACADEMICS.
AND I ACTUALLY THINK THAT
HAVING MODIFYING THE
REQUIREMENTS BE ACCEPTED INTO
THE T32 PROGRAM AS WELL AS
F31'S AS WELL AS WHAT ARE SOME
OF THE TRAINING SO THAT WHEN
THEY ACTUALLY HIT THE INDUSTRY
THAT THEY HAVE AN EDGE UP WOULD
BE BENEFICIAL FOR THE TRAINEES,
AS WELL AS FOR, I ACTUALLY
THINK IT WOULD BE BENEFICIAL
FOR ACADEMICS TOO.
SOMETIMES THE TRAINEES, THEY
LOOK AT THE ACADEMICS AND THEY
GO, OH WOW.
THERE'S A LOT OF DIFFICULTIES
IN ACADEMICS.
BUT THERE'S ALSO DIFFICULTIES
IN ANY POSITION IN INDUSTRY.
SO GIVING THEM SOME EXPOSURE TO
INDUSTRY WE MAY END UP
RECRUITING MORE INTO THE
ACADEMIC REALM.
I WOULD ENCOURAGE THE PEOPLE
THAT PUT TOGETHER THESE
TRAINING PROGRAMS TO TRY TO
FIGURE OUT HOW TO GIVE THE
GRADUATE STUDENTS THE EXPOSURE
TO INDUSTRY THAT THEY WANT IN
THEIR TRAINING PROGRAMS, SO
THAT THEY CAN MAKE INFORMED
DECISIONS AT THAT JUNCTURE OF
WHAT THEY ARE GOING TO DO AFTER
THEIR TRAINING.
>> CHRIS: YEAH, THANK YOU.
I THINK THAT'S VALUABLE
FEEDBACK.
I CAN'T NAME ANY NAMES BECAUSE
WE CAN'T IDENTIFY THE P.I.'S
BUT WE SAW WIDE RANGE.
SO THAT'S ANOTHER ARGUMENT FOR
A NUMBER OF PEOPLE SAID THEY
REALLY LIKE THE ANNUAL MEETING
BECAUSE OF THE EXPOSURE TO THE
PI'S FROM OTHER PROGRAMS AND
BEING ABLE TO EXCHANGE
INFORMATION LIKE THAT.
SO TO ME THAT'S A VENUE THIS
CAN TAKE PLACE AS WELL, THOSE
DISCUSSIONS AND SHARING
INFORMATION.
>> CAROLYN: CASEY, GO AHEAD.
>> CASEY: EXCELLENT DATA.
WE ALWAYS LIKE TO SEE MORE.
I WAS WONDERING IF THERE ARE
PLANS TO FOLLOW THIS GROUP OVER
TIME TO DO A SIMILAR TYPE OF
SURVEY IN LIKE A FEW YEARS
LATER TO SEE IF THINGS HAVE
CHANGED.
AND IF YOU ALL ARE THINKING
ABOUT THAT?
>> CHRIS: YEAH, GREAT QUESTION,
WE HADN'T PLANNED THAT YET.
I THINK WE HAVE TO SEE WHAT THE
FUNDING ENVIRONMENT HOLDS ON
OUR END TO SEE IF THAT'S MONEY
THAT WE HAVE.
BUT YEAH, ABSOLUTELY.
>> CASEY: ONE THING I WOULD BE
INTERESTED IN SEEING ALSO,
WHICH COMMUNITIES THE GRADUATES
ARE A PART OF, IF THAT'S A
QUESTION THAT YOU DIDN'T ANSWER
THIS TIME AROUND, MAYBE NEXT
TIME AROUND IT WOULD BE GOOD TO
SEE WHERE, IN ADDITION TO
GEOGRAPHICALLY, WHICH
COMMUNITIES THEY ARE ALSO PART
OF.
>> CHRIS: YES, THOSE ARE DATA
WE HAVE, WE JUST DIDN'T SHOW
THEM TODAY.
BUT YEAH.
>> CAROLYN: BRUCE, GO AHEAD.
>> BRUCE: YEAH, I WOULD BROADEN
THE CONCEPT OF WHAT ARE BEING
CALLED NON-TRADITIONAL CAREER
PATHS BEYOND INDUSTRY TO
INCLUDE SCIENTIFIC
COMMUNICATIONS, FOR EXAMPLE,
SCIENTIFIC PUBLISHING.
YOU COULD GO ON AND ON, I
THINK, WITH MANY THINGS.
IT STRIKES ME THAT IT WILL BE
INCREASINGLY IMPORTANT TO
EXPOSE TRAINEES, NOT JUST TO
THESE ALTERNATIVE CAREER PATHS,
BUT ALSO SOMEWHERE ALONG THE
WAY IT MAY BE HELPFUL TO
PROVIDE EDUCATION, I GUESS YOU
COULD SAY IN HOW SCIENCE WORKS.
AND WHAT I MEAN BY THAT IS, HOW
THIS FUNDING ACTUALLY WORKS.
UNFORTUNATELY PEOPLE ARE
GETTING A PRETTY HARD LESSON,
LIKE FOR EXAMPLE, WHAT ARE
INDIRECT COSTS RIGHT NOW.
IT WOULD PROBABLY BEHOOVE
PEOPLE TO HAVE BEEN EDUCATED
ABOUT THE OVERALL KIND OF
SCIENTIFIC INFRASTRUCTURE THAT
EXISTS AND ENCOMPASSES AN
ENTIRE ECOSYSTEM OF ACADEMIC
AND INDUSTRY AND PROFESSIONAL
SOCIETY AND SO FORTH.
KIND OF AVENUES.
SO THAT THEY ACTUALLY
UNDERSTAND THE COMPLEX WORLD
THEY ARE MOVING INTO, AND IT
GOES WAY BEYOND JUST THE
INDIVIDUAL LAB, MAYBE, THAT
THEY ARE WORKING.
>> CHRIS: YEAH, I THINK THAT'S
A GREAT POINT.
I CAN SPEAK TO MY OWN
EXPERIENCE, WHEN I WAS IN
GRADUATE SCHOOL, LIKE KELLY
SAID, I LOOKED AT MY P.I.'S AND
THOUGHT I'M NOT GOING INTO THAT.
THAT LOOKS HARD, I SAW PEOPLE
PUTTING OUT 80-90 APPLICATIONS
THIS IS WHEN DINOSAURS WERE
WALKING OUTSIDE OUR BUILDINGS
AND NOT GETTING JOBS AND I'M
NOT SURE IT'S ANY BETTER.
SPEAKING AS SOMEONE WHO IS NOW
A P.I., NO ONE IS MORE SHOCKED
THAN ME TO FIGURE THAT OUT, I
AGREE.
I THINK MORE PLACES ARE DOING
THAT NOW.
I AGREE WITH KELLY'S STATEMENT
THAT ACADEMIA IS THE
ALTERNATIVE CAREER NOW,
BASICALLY.
BUT IT SOUNDS LIKE OUR TRAINEES
THAT IS A PERENNIAL THING THEY
ARE STILL ASKING FOR EXPOSURE
TO WHAT ALL IS OUT THERE.
>> CAROLYN: ANY OTHER QUESTIONS
FOR CHRIS?
OR COMMENTS FROM ALL OF US,
WHAT'S GOING ON IN TRAINING IN
YOUR WORLD?
ALL RIGHT, THANK YOU, CHRIS.
SO YOU MAY HAVE NOTICED, IF YOU
HAVE BEEN FOLLOWING ALONG THAT
WE ARE QUITE A BIT AHEAD IN OUR
AGENDA.
AND SO WE ARE GOING TO, IF IT'S
ALL RIGHT WITH OUR
COUNCILMEMBERS, PLOW RIGHT INTO
OUR CONCEPT CLEARANCES.
AND KNOWING THAT WE MAY LOSE
BRUCE FOR A LITTLE BIT OF TIME,
WE ARE GOING TO GO AHEAD AND
START WITH THE ONE WHERE HE IS
LEADING OFF DISCUSSION, THE
CLINICAL DATA ECOSYSTEM FOR
GENOMICS AND TERI MANOLIO WILL
BE PRESENTING.
>> TERI: GREAT, THANKS, JEN AND
THANK YOU FOR BEING FLEXIBLE TO
WE CAN LET CHRIS GET TO HIS
CALL.
I'M PRESENTING THIS CONCEPT FOR
CLINICAL DATA ECOSYSTEM FOR
GENOMICS, THIS IS ENTIRELY THE
WORK OF NEPHI WALTON, A
PROBATIONARY EMPLOYEE WHO WAS
SEPARATED IN EARLY FEBRUARY.
WE MISS HIM AND ALL OF OUR
SEPARATED EMPLOYEES GREATLY.
THE BACKGROUND OF THIS ACTUALLY
STARTED WITH A WORKSHOP THAT
NEPHI ORGANIZED BACK IN APRIL
OF 2024, LOOKING AT HOW WE
COULD BETTER INTEGRATE GENOMIC
DATA INTO MEDICAL RECORDS AND
CLINICAL DECISION SUPPORT TO
MAKE THEM AVAILABLE FOR
CLINICIANS TO BE ABLE TO USE IN
CLINICAL CARE, AND A KEY
RECOMMENDATION FROM THAT GROUP
IS TO ESTABLISH A NETWORK THAT
WOULD BASICALLY PILOT AND TEST
WAYS TO ADDRESS CHALLENGES OF
INTEGRATING THESE DATA AND
ALLOWING THEIR LONGITUDINAL USE
IN MULTIPLE SETTINGS IN
CLINICAL CARE, INCLUDING MOST
IMPORTANTLY TO ME AS A PRIMARY
CARE CLINICIAN IN PRIMARY CARE.
SO THE OBJECTIVES OF THE
PROGRAM THAT WE ARE BRINGING TO
YOU TODAY, THE CONCEPT ARE TO
ESTABLISH A PILOT DATA
ECOSYSTEM THAT WOULD ENABLE THE
SHARING AND SORT OF TEST
DIFFERENT MODELS OF DOING THIS
OF GENOMIC STRUCTURED DATA
ACROSS DIFFERENT HEALTHCARE
SETTINGS INCLUDING PRIMARY
CARE, CREATE STANDARDIZED
APPLICATION PROGRAMMING
INTERFACES OR API'S TO SUPPORT
ACCESS TO THESE DATA.
DEVELOP OPEN-SOURCE CLINICAL
SOFTWARE APPLICATIONS AND
DATABASES TO UTILIZE THESE
API'S.
DEMONSTRATE HOW THIS ECOSYSTEM
CAN SUPPORT ACCESS TO PATIENT'S
GENOMIC DATA AND LINK THAT TO
THEIR CLINICAL DATA, AS THEY
TRAVEL ACROSS DIFFERENT
HEALTHCARE SYSTEMS THROUGHOUT
THEIR LIVES, POTENTIALLY.
AND THEN REFINE AND DEVELOP
THESE PRACTICES INTO
IMPLEMENTATION RESOURCES THAT
COULD BE WIDELY SHARED AND
ADOPTED.
WE KNOW THAT THE ROLE OF
GENOMIC DATA IN HEALTHCARE IS
GROWING AND HAS GROWN IN
SEVERAL DIFFERENT DOMAINS.
CANCER SCREENING,
PHARMACOGENOMICS RARE DISEASES,
ET CETERA.
HEALTHCARE PROVIDERS SHOULD BE
ABLE TO ACCESS THESE DATA
LONGITUDINAL AND ASSESS RESULTS
OR SOMEONE SHOULD DO IT AND
PROVIDE IT TO THEM TO ADAPT THE
CARE BASED ON NEW DISCOVERIES
OR APPLICATIONS AND GSD OR
GENOMIC STRUCTURED DATA SHOULD
BE INTEGRATED INTO A PATIENT'S
PRIMARY SOURCE OF CARE WHILE
ENABLING EXCHANGE OF RESULTS
FROM DIFFERENT PROVIDERS FROM
WHOM THEY MAY BE RECEIVING CARE.
OUR CURRENT STATE IS FAR FROM
THAT, HOWEVER.
SEQUENCING DATA ARE TYPICALLY
TRANSMITTED STILL IN SOME
INSTANCES, THERE ARE SOME
EXCEPTIONS AS NON COMPUTABLE
PDF'S, THERE'S A VAST AMOUNT,
SOMETIMES THE ENTIRE GENOME
SEQUENCE DATA THAT ARE RETAINED
AT THE LAB, OR MAY NOT EVEN BE
RETAINED BUT OFTEN RETAINED
THERE THAT ARE NOT REPORTED AND
THEY COULD BE VERY VALUABLE IN
PATIENT CARE.
ALSO, EACH EXCHANGE OF GENETIC
DATA BETWEEN LAB AND CLINICAL
SETTING, OR BETWEEN LABS OR
WHATEVER TEND TO REQUIRE A
CUSTOM INTERFACE.
SO THIS IS NOT SCALABLE IN ANY
WAY.
AND NEEDS TO BE MUCH MORE
STREAMLINED AND SYSTEMATIC
APPROACH TO THAT.
GENETIC DATA FOR EACH PATIENT
ARE TYPICALLY STORED AS
INDIVIDUAL FILES FOR EACH
PATIENT AND DATA STANDARDS ARE
CURRENTLY NOT TOTALLY ADEQUATE.
THEY ARE IMPROVING BUT NOT
ADEQUATE FOR FACILITATING
EXCHANGE OF GSD ACROSS SETTINGS.
HAS THIS BEEN USED?
OKAY, EVEN IF IT HAS.
SUPER.
SO SOME EARLY SUCCESSES THAT WE
HAVE SEEN OUT IN THE RESEARCH,
PARTICULARLY IN TERTIARY CARE
SETTINGS THERE'S BEEN LIMITED
INTEGRATION OF STRUCTURED
GENOME RESULTS INTO THEENSINGER
HR AND THAT'S NOW BEEN ACHIEVED
BY OVER 20 SYSTEMS IN THE U.S.
A VERY NICE DEMONSTRATION
PROJECT OF THIS WAS THE GENETIC
CANCER RISK DETECTOR OR GARDE
PROGRAM.
FIRST DEPLOYMENT OF A
GENERALIZABLE HL7
STANDARDS-BASED METHOD FOR
POPULATION LEVEL CDS FOR
GENOMICS.
IMPLEMENTED STANDARDS BASED AND
WAS SUCCESSFULLY DEPLOYED
ACROSS THREE HEALTHCARE SYSTEMS
ACROSS THE COUNTRY.
SO REALLY A VERY NICE
PROTOTYPE, AN EARLY ONE.
AND EXPANSION OF THESE KINDS OF
EARLY SUCCESSES COULD ENABLE,
WE WOULD EXPECT, INTEGRATION OF
GENOMIC DATA INTO HEALTH
INFORMATION EXCHANGES THAT ARE
SORT OF CLUSTERS OF SOMETIMES
STATEWIDE, SOMETIMES REGION
WIDE OF CARE RECORDS THAT CAN
BE USED IN FOLLOWING A PATIENT
FROM HEALTHCARE SETTING TO
HEALTHCARE SETTING THAT MAKES
THE DATA AVAILABLE ACROSS
MULTIPLE PROVIDERS, ACROSS
CLINICAL FACILITIES AND WITH
PATIENTS TO COORDINATE AND
IMPROVE THEIR CARE.
SO OUR DESIRED STATE AND WHAT
WE WOULD LIKE TO PILOT IN THIS
PROGRAM ARE SEQUENCING DATA
WOULD BE READILY AVAILABLE AS
STRUCTURED DATA IN A
STANDARDIZED COMPUTABLE FORMAT
THAT DOESN'T REQUIRE
INDIVIDUALIZED INTERFACES.
THAT THEY ARE AVAILABLE TO
EVERY MEMBER OF WHATEVER
NETWORK IS ESTABLISHED AND
OBVIOUSLY WITH APPROPRIATE
CONFIDENTIALITY AND PRIVACY
PROTECTIONS.
THAT THEY ARE ACCESSIBLE IN ALL
THE SETTING WHERE'S PATIENTS
WOULD RECEIVE HEALTHCARE AND
EVEN POTENTIALLY TO PATIENTS.
ABLE TO PROVIDE INFORMATICS AND
DATA GOVERNANCE, SUCH AS ACCESS
CONTROL AND AUTHENTICATION TO
FACILITATE EASY EXCHANGE AND
THE NETWORK WOULD DEMONSTRATE
THESE CAPABILITIES ACROSS
MULTIPLE DISTINCT BUT
INTEROPERABLE HEALTHCARE
SYSTEMS AND COLLABORATE TO
DEMONSTRATE THE EFFECTIVENESS,
MODIFY AND IMPROVE IT.
THIS LITTLE CARTOON IS SHOWING
US THE SORT OF LIFE SPAN OF A
GIVEN INDIVIDUAL AND HOW
GENOMIC DATA MIGHT BE USED
ACROSS THAT.
OBVIOUSLY WHERE THERE'S NEWBORN
SEQUENCING OR EVEN PRENATAL
GENETIC TESTING THEY WOULD BE
USED IN THAT SETTING AND COULD
POTENTIALLY HAVE AN IMPACT
LATER IN LIFE AS WELL.
GENETIC DIAGNOSIS COULD BE MADE
AT MULTIPLE TIME POINTS
THROUGHOUT THE LIFE SPAN.
OPPORTUNITIES FOR RESEARCH,
PHARMACOGENETICS, PARTICULARLY
INCREASING AS ONE GETS A LITTLE
BIT OLDER AND ACCUMULATES BOTH
CO-EXISTING ILLNESSES AND DRUGS.
AND POLYGENIC RISK SCORE COULD
BE PRODUCED.
AND AI ALGORITHMS COULD BE
PRODUCED ACROSS THESE TIME
POINTS TOO.
ALL OF THESE ARE POSSIBILITIES
FOR GENETIC DATA REPOSITORY WE
WOULD LIKE TO TRY TO FACILITATE.
TYPES OF OPERATIONS THIS COULD
ENABLE WOULD INCLUDE, JUST
THINKING OF GS DATA SIT IN A
GENETIC REPOSITORY WOULD LIKELY
BE AT A LAB, BUT COULD
CONCEIVABLY BE AT ANOTHER
HEALTHCARE SYSTEM THAT
GENERATED THOSE DATA AND THE
API'S COULD BE DEVELOPED THAT
WOULD RECEIVE THE DATA REQUEST
AND PASS BACK RESPONSES.
THREE EXAMPLES, THERE ARE MANY.
BUT ONE MIGHT BE A SPECIFIC
DATA REQUEST FROM A CLINICIAN,
A BREAST SURGEON WHO WANTS TO
KNOW ALL THE RARE YANTS IN THE
PATIENT'S BRCA1.
REQUESTER RECEIVES FW, SD FROM
REPOSITORY AND PERFORMS
OPERATION ON DATA TO DETERMINE,
AND WOULD PROVIDE THE CARE TO
THE PATIENT FOR THAT.
OR REQUEST THE FULL DATA.
MIGHT ASK FOR THE PATIENT'S
ENTIRE GENOME BE GIVEN A
GENOMIC VCF.
THEY COULD SEARCH IF THEY ARE
CAPABLE THEREOF AND INTERESTED
FOR PATIENT RELEVANT PATH
AGAINIC OR LIKELY PATHOGENIC
VARIANTS IN OTHER GENES AND
PROVIDE CARE FOR THE PATIENT.
OR COULD BE A NO TOUCH REQUEST,
WHICH WOULD BE THE SORT OF
THING I WOULD DO WITH SAY THEY
ARE LOOKING FOR A PATIENT'S
POLYGENIC RISK SCORE FOR
CORONARY DISEASE.
DOES ADDRESS CERTAIN CONCERNS
RELATED TO CONFIDENTIALITY,
THEY ASK TO PERFORM OPERATION
ON THE DATA SO CALCULATE THIS
PARTICULAR POLYGENIC RISK SCORE
OR ALL FOR CORONARY DISEASE,
WHICH THERE ARE MANY, SEND THE
RESULT.
BUT THE REQUESTER NEVER TOUCHES
THE GENOME INC DATA DIRECTLY.
THIS COULD BE SHOWN
SCHEMATICKLY IN THESE DIAGRAMS
THE DATA PEOPLE LOVE AND I HAVE
TROUBLE NAVIGATING.
BUT THIS SHOWS THE GENOMIC
SEQUENCE DATA IN THE LIGHT BLUE
BARREL THING ON THE UPPER LEFT
HAND CORNER.
THE API IS THIS SORT OF ROYAL
BLUE WIDGET THAT IS IT THIS
CALCULATION.
SPECIFIC DATA REQUEST IS SENT,
IT GOES TO THE GENERAL
REPOSITORY, IT SPITS OUT THE
SUBJECT'S DATA.
THERE'S A PROCESS THE REQUESTER
WOULD USE TO FIGURE OUT ARE
THERE PATHOGENIC VARIANTS, THEY
GET THE RESULT AND GO ONTO CARE
FOR THE PATIENT.
REPOSITORY SENDS COMPRISING ALL
THE THE CHD PRS.
IN A SECOND EXAMPLE, YOU COULD
GET, HAVE A FULL DATA REQUEST.
AGAIN, THAT REQUEST IS SENT TO
THE API, THE DATA ARE SENT OUT,
AGAIN A PROCESSING STEP AND THE
RESULT SO THE REQUESTER THEN
MODELS FOR EXAMPLE, MULTIPLE
CHD SCORES OR COULD BE SCORES
FOR MULTIPLE DISEASES.
AND IN AN NO-TOUCH APPROACH,
THIS IS SLIGHTLY DIFFERENT
REQUEST, SO THEY CONCEIVE OF
THE REQUEST BUT THEY SEND THE
REQUEST THROUGH THE API, THAT
IS IT THE DATA PROCESSING ON
THE DATA, SENDS BACK THE RESULT
AND THEN THEY CARE FOR THE
PATIENT.
WHAT DID I DO?
SOMETHING BAD.
CAN YOU RESCUE ME, PLEASE?
THERE WE GO, I WILL TAKE IT
FROM HERE, I APPRECIATE IT.
SO WHAT WE ARE PROPOSING --
OH, IT'S NOT SHOWING?
OH, OKAY.
SORRY.
WE ARE PROPOSING 1-3 RFA'S,
CAROLYN MENTION DOLLARS THERE'S
A MOVE OF LIMITING AND
REDEUCING THE NUMBER OF
SOLICITATIONS OR NOFO'S WE SEND
OUT.
ONE WAY TO APPROACH AND
SIMPLIFY WOULD BE TO PUT THE
REQUEST FOR ALL THREE TYPES OF
CENTERS, LABORATORY, CLINICAL
SITES AND COORDINATING CENTER
INTO A SINGLE REQUEST FOR
APPLICATIONS OR NOFO.
AND HONESTLY, WHEN WE WRITE
THESE THINGS WE TEND TO PUT 80%
OF THE INFORMATION IS IN EACH
OF THEM, THEY HAVE TO KNOW WHAT
EACH OTHER IS DOING IN ORDER TO
WRITE THEIR APPLICATION.
WE COULD SAY SOMETHING LIKE,
ALL RIGHT, IF YOU ARE APPLYING
FOR THE COORDINATING CENTER
MAKE SURE YOU ADDRESS THESE
TASKS, IF APPLYING FOR THE
CLINICAL TASKS ADDRESS THESE.
IT'S NOT CLEAR YET WHERE IT'S
GOING, THAT'S AN INNOVATION WE
HAVE YET TO SEE IMPLEMENTED.
IT COULD BE ONE TO THREE.
WE ARE LOOKING A DATABASE THAT
WOULD SERVE UP GENOME INC TATE
TA.
WE ARE PROPOSING SIMULATED
RATHER THAN ACTUAL PATIENT DATA
TO AVOID NECESSITIES FOR
OBVIOUSLY CONSENT AND IRB, ET
CETERA.
AND THE FACT THAT WE REALLY
DON'T, FOR THIS PILOT PROJECT,
WE REALLY DON'T NEED ACTUAL
PATIENT DATA, SO SIMULATED DATA
WILL WORK JUST FINE.
AND DEVELOP GENOMIC OPERATIONS
FOR THE API'S THAT THEY DEVELOP.
CLINICAL SITES SIMILARLY WOULD
DEVELOP AND DEPLOY APPLICATIONS
THAT UTILIZE THE GENOMIC DATA
IN CLINICAL CARE AND THEY WOULD
DEVELOP ASSIMILATED DATASET
THAT COINCIDES WITH THE GENOMIC
TATE TA SETS AND COORDINATING
CENTER WOULD KEEP ALL OF THIS
HUM TOGETHER, COORDINATING,
SHARING AND IMPLEMENTATION
EFFORTS AMONG THOSE SITES
THROUGH IN-PERSON MEETINGS ET
CETERA BUT ALSO COMPILE
ORGANIZED BEST PRACTICES, THE
API'S AND VARIOUS OPEN SOURCE
PROGRAMMING ET CETERA.
BROAD DISTRIBUTION.
AND FACILITATE ENGAGEMENT WHICH
WILL BE IMPORTANT FOR
STANDARDIZATION AND LATER
ACCEPTANCE, WITH STANDARDS
ORGANIZATIONS AND INDUSTRY
PARTNERS.
SO THE PROPOSED SCOPE, SORRY,
AND CONTINUING ON THE PROPOSED
SCOPE, METRICS TO ASSESS THE
SUCCESS AND SCAPABILITY OF THE
IMPLEMENTATION COULD INCLUDE
THINGS LIKE EASE OF
IMPLEMENTATION, PORTABILITY OF
THE APPLICATIONS, CUSTOMIZATION
REQUIREMENTS, DATA
AVAILABILITY, ET CETERA.
THERE COULD BE TECHNICAL
METRICS SUCH AS RESPONSE TIME
OR ERROR RATE, ET CETERA.
QUALITATIVE ASSESSMENTS BY END
USERS, HOW EASY WAS THIS TO
USE, HOW WOULD YOU SUGGEST WE
IMPROVE IT, ET CETERA.
AND SUSTAINABILITY AGAIN,
ASSESS THROUGH EVALUATION AND
PROPOSED ADOPTIONS BY STANDARDS
BODIES SUCH AS THE GENOMIC
GLOBAL ALLIANCE, OR HL7.
AND AGAIN, MECHANISMS OF
SUPPORT WOULD BE U01
COOPERATIVE AGREEMENTS FOR ONE
COORDINATING CENTER, A COUPLE
OF CLINICAL SITES, A COUPLE OF
LABORATORY SITES.
WE PREFER MORE THAN ONE BECAUSE
WE WANT TO BE SURE IT'S
WORKABLE ACROSS MULTIPLE
SETTINGS.
ESTIMATED $6 MILLION PER YEAR
FOR TOTAL OF FIVE YEARS AND WE
MAY SEEK FUNDS FROM OTHER IC'S
TO INCREASE THE NUMBER OF SITES
OR SOFTWARE APPLICATIONS.
SO THAT'S ALL I HAVE TO SAY.
I WILL STOP THERE AND TURN TO
BRUCE KORF AS THE FIRST
DISCUSSANT.
>> BRUCE: THANKS, TERI AND
THANKS FOR ACCOMMODATING MY
SCHEDULE, I HAVE TO JUMP OFF AT
2:00 FOR JUST A LITTLE WHILE.
AS A STARTING POINT, I'M REALLY
EXCITED TO SEE THIS.
THE ABILITY TO INTEGRATE
GENOMIC DATA INTO THE
MAINSTREAM OF HEALTHCARE IS
GOING IT BE CRITICAL, IF WE ARE
GOING TO SEE THE POTENTIAL OF
GENOMIC MEDICINE BE REALIZED ON
A ROUTINE BASIS.
SO GETTING AWAY FROM THE PDF
ERA IS GOING TO BE ABSOLUTELY
CRITICAL.
A FEW THINGS JUST OCCURRED TO
ME IN WHICH MAY OR MAY NOT FIT
INTO THE SCOPE OF THIS, I'LL
JUST MENTION A FEW POINTS THAT
I THINK MIGHT BE RELEVANT.
IT'S GOING TO BE IMPORTANT, I
THINK, ALONG THE WAY TO DEVELOP
USE CASES.
THE WORST THAT COULD HAPPEN IS
THE DATA DOESN'T GET INTO THE
MEDICAL RECORD SO IT'S NOT
THERE.
THE SECOND WORST IS IT IS
BURIED THERE IN A WAY NO ONE
KNOWS HOW TO ACCESS OR USE IT.
THERE WILL BE THE NEED NOT JUST
FOR AFICIONADOS TO ACCESS IT
BUT TO FIND ITS WAY INTO THE
HANDS OF PEOPLE WHO AREN'T
REALLY VERY FAMILIAR WITH
GENOMICS BUT WILL STILL FIND IT
VALUABLE FOR THEIR CARE.
SO ULTIMATELY, I THINK, WHETHER
IMMEDIATELY OR NOT, THERE'S
GOING TO NEED TO BE INTERFACES
INTO CLINICIANS WHO ARE
UNFAMILIAR WITH GENOMICS, AS
WELL AS EDUCATION ABOUT THE USE.
AND THAT MAY APPLY NOT ONLY TO
THE CLINICIANS BUT ALSO TO
PATIENTS.
ONE THING THAT I THINK MAY
EVOLVE OVER TIME IS AN INTEREST
ON THE PART OF AT LEAST SOME
PEOPLE, TO HAVE DIRECT ACCESS
TO THEIR OWN GENOMIC DATA, NOT
NECESSARILY ONLY THROUGH A
CLINICIAN BUT TO EXPLORE ON
THEIR OWN.
THE ABILITY TO HAVE SOME
CONTROL OF THAT COULD BECOME
SOMETHING SOME PEOPLE WILL AT
LEAST BE INTERESTED IN.
AND HAVING SOME CONSUMER INPUT
INTO THIS PROCESS MIGHT
ACTUALLY BE VALUABLE.
EVEN FROM AN EARLY STAGE.
THERE ARE GOING TO BE ISSUES OF
TRUST WITH ALL OF THESE DATA,
FOR EXAMPLE, I THINK ARE GOING
TO NEED TO BE ADDRESSED OVER
TIME.
THERE'S ALSO, THE POTENTIAL, IF
YOU THINK ABOUT IT, YOU MADE
THE POINT THAT A SURGEON COULD
ASK ABOUT A BRCA GENE CHANGE
AND THAT CERTAINLY IS EASY TO
MATHISEN NAIR YO.
SCENARIO.
BUT THE OTHER SIDE IS SOMEONE
DEVELOPS BREAST CANCER AND THEN
AFTER THE FACT GOES AND
DISCOVERS THAT IT WAS KNOWN ALL
ALONG THAT THERE WAS A BRCA-1
VARIANT THAT NO ONE PAID ANY
ATTENTION TO.
AND HOW TO NAVIGATE THAT, WHAT
COULD ACTUALLY BE A MEDICAL
LEGAL SET OF ISSUES.
IF THE INFORMATION IS
ACCESSIBLE, THERE'S MAYBE,
POTENTIALLY ANYWAY AN
EXPECTATION IT WILL BE ACCESSED
TO THE BENEFIT OF A PATIENT.
OF COURSE IT GETS EVEN MORE
COMPLICATED WHEN YOU REALIZE
THERE WILL BE VUS'S OR OTHER
THINGS THAT ARE PRONE TO
MISINTERPRETATION.
I THINK PUTTING THIS
INFORMATION AT THE HANDS OF
CLINICIANS IS A FANTASTIC AND
IMPORTANT STEP FORWARD.
BUT IT RAISES A LOT OF SORT OF
LOGISTICAL ISSUES, IN TERMS OF
HOW IT WILL BE USED, HOW PEOPLE
WILL KNOW THAT IT'S THERE, AND
KNOW THAT THEY SHOULD QUERY IT.
THERE WILL ALSO BE QUESTIONS OF
HOW INFORMATION IS UPDATED.
THE SEQUENCE AND ITS
INTERPRETATION TODAY, NOT ONLY
WILL CHANGE WITH THE EVOLUTION
OF A PATIENT'S MEDICAL HISTORY,
BUT ALSO AS MORE KNOWLEDGE IS
GAINED AND HOW THAT INFORMATION
IS MAINTAINED IN AN UP-TO-DATE
SORT OF CURATED MANNER IS, I
THINK, ALSO GOING TO BE
IMPORTANT.
I GUESS IN SUMMARY, I GUESS
IT'S A TERRIFIC STEP THAT IS
VERY, VERY MUCH NEEDED AND
REALLY WOULD LOOK FORWARD TO
THE KIND OF PROGRESS THAT THIS
WILL GENERATE.
AND I THINK IT'S GOING TO RAISE
ANY NUMBER OF ADDITIONAL
QUESTIONS.
SOME OF WHICH MAY BE POSSIBLE
TO EMBED IN THE WAY THIS IS PUT
TOGETHER.
AND SOME OF WHICH MAY BE NEXT
STEPS THAT WOULD HAPPEN ONCE
THE INFORMATION IS POTENTIALLY
AT HAND.
I WILL PAUSE AT THAT POINT, BUT
THOSE ARE SOME OF THE THINGS
THAT HAVE OCCURRED TO ME.
>> TERI: GREAT, SUPER.
THOSE WERE GREAT COMMENTS.
THANK YOU.
I BELIEVE THE OTHER DISCUSSANT
WAS CASEY.
>> KELLY: IT'S KELLY.
>> JEN: KELLY, GO AHEAD AND
THEN WE WILL WELCOME COMMENTS
FROM CASEY AND EVERYONE ELSE.
>> KELLY: I WANT TO SECOND
THOSE COMMENTS.
YOU TOUCHED UPON IT IN YOUR
SLIDE OF ALL THE POTENTIAL WAYS
SUCH DATA COULD BE USED.
I THINK REALLY ANTICIPATING THE
VALUE THAT
THIS TYPE OF DATABASE WOULD
PROVIDE FOR RESEARCH, AND THE
ABILITY TO ACTUALLY, NOT ONLY
PUT INFORMATION INTO, TO
AUGMENT THAT RESOURCE BASED ON
EXTERNAL RESEARCH BUT THE VALUE
OF THIS INFORMATION FOR
RESEARCHERS THEMSELVES TO GAIN
NEW INFORMATION.
I WANT TO REALLY EMPHASIZE THE
IMPORTANCE OF THINKING OF THAT
UP FRONT AND WHAT TYPE OF
CONSENSUS, WHAT TYPE OF OTHER
INFORMATION, HOW DOES THE BACK
END NEED TO BE DEVELOPED?
AND WOULD THE DATA BE SILOED
AND WOULD PEOPLE HAVE TO BE
ABLE TO ACCESS IT THROUGH A
SILOED EVENT, I THINK THAT'S
KEY.
SO BUILDING THAT INTO THE
PROGRAM.
>> TERI: THANKS, KELLY.
THAT'S VERY IMPORTANT, AND
THAT'S WHY INVESTIGATORS WHEN
THEY COME ON BOARD MAY CHANGE
THIS.
BUT WE ARE PROPOSING SIMULATED
DATA SO WE CAN GET THE SYSTEM
DOWN, GET THE CHANGES IN
INFRASTRUCTURE UNDERSTOOD AND
SORT OF PLAYED WITH AND KICKED
AROUND WITHOUT HAVING TO
ADDRESS THESE KINDS OF CONCERNS.
AND THEN HOPEFULLY, AS WE ARE
BUILDING IT OUT FOR SOMETHING
THAT COULD BE DISSEMINATED,
REALLY TRY TO TACKLE THOSE
ISSUES IN PREPARATION FOR USING
REAL PATIENT DATA.
OTHER COMMENTS?
>> CASEY: I HAVE A COMMENT.
ALONG THE LINE WITH WHAT BRUCE
WAS SAYING EARLIER, THERE'S
SOME SIMULATED DATA THAT IS
BEING USED.
BUT THERE'S A NEW USE CASE
WHERE PATIENTS WILL BE GETTING
THE RESULTS, LIKE UPON ORDERING
A TEST, THEY COULD BE GETTING
THE RESULTS BEFORE THE
CLINICIAN.
AND SO THAT IS SOMETHING THAT
WILL BE GREAT TO EXPLORE
FURTHER.
JUST RIGHT NOW WITH PDF'S IT'S
STILL, THERE'S KIND OF A STOP
BEFORE A CLINICIAN CAN
INTERVENE BEFORE THE PATIENT
GETS ACCESS TO THEIR RESULTS.
SO THAT'S AN INTERESTING USE
CASE.
AND THEN THE OTHER ASPECT IS,
WHAT IS BEING PROPOSED IS
MAKING DATA AVAILABLE AT
MULTIPLE POINTS OVER THE LIFE,
OVER THE COURSE OF LIFE.
AND SO, SOME OF THOSE SCENARIOS
MAY NOT HAVE BEEN EXPLORED IN
OTHER NETWORKS.
AND SO JUST THINKING ABOUT, IF
THEY ARE ONES THAT COULD BE
EXPLORED IN SOME WAY, IN THE
LINE, LIKE I DON'T KNOW FOR THE
COMING UP LIKE E-CONSULT
NETWORK FOR EXAMPLE, MAYBE
THERE'S WAYS TO THINK ABOUT
CONSULTATION ON THOSE DIFFERENT
POINTS IN TIME.
SO ANYWAY, I JUST WANTED TO
KIND OF AGREE WITH THE POINT
ABOUT EXPLORING THESE USE CASES
OF THESE DIFFERENT POINTS IN
TIME AND HOW THEY ARE DIFFERENT
WHEN THE DATA IS COMPLETELY
COMPUTABLE AND CONNECTED WITH
CLINICAL DATA IS CONNECTED.
BUT VERY EXCITED TO HEAR THIS.
>> TERI: SUPER, THANK YOU,
CASEY.
ONE COULD EVEN IMAGINE ONE OF
THE ADVANTAGES OF USING
SIMULATED DATA IS YOU COULD AGE
YOUR PATIENT.
SAY TOMORROW WE DECIDE THAT
JOHN INSTEAD OF BEING 25 HE IS
NOW 45 OR 65 OR 85.
OR HE HAS SUDDENLY GONE TO I A
DIFFERENT STATE AND BEING CARED
FOR THERE.
YEAH, THOSE ARE GREAT IDEAS,
THANK YOU.
>> JEN: NANCY?
>> NANCY: I JUST WANTED TO
AGREE VEHEMENTLY WITH OUR
EXPERTS.
AND I ESPECIALLY WANTED TO
CIRCLE BACK TO ONE OF THE
THINGS KELLY SAID.
I DON'T THINK PEOPLE APPRECIATE
HOW MUCH GENOME DATA ARE
ACTUALLY AVAILABLE AND CAN BE
HUGELY VALUABLE EVEN NOW.
WE UNDERTOOK, I SHOULD SAY, ONE
OF MY COLLEAGUES UNDERTOOK,
LITERALLY A YEARS LONG EFFORT
TO DO THIS AT VANDERBILT.
IT DID TAKE YEARS BUT IT TURNED
OUT WE HAD DATA ON MORE THAN
100,000 PEOPLE WITH CLINICAL
GENETIC INFORMATION.
AND THE VALUE OF THAT, IT HAS
JUST BEEN INCREDIBLE ALREADY,
IN TERMS OF HOW USEFUL AN
AUXILIARY DATABASE IT IS FOR
SEARCHING IN THE CONTEXT OF
UDN-TYPE QUESTIONS.
BUT ALSO OTHER TYPES OF
QUESTIONS.
I THINK THIS IS OVERDUE BUT
PART OF THE CHALLENGE HAS
HISTORICALLY BEEN WHEN IS THE
RIGHT TIME TO MAKE THIS
INVESTMENT?
AND I THINK IT'S OVERDUE.
SO THIS WILL BE A VERY TIMELY
AND IMPORTANT INVESTMENT.
BECAUSE I'M SURE THAT OTHER
MEDICAL CENTERS HAVE ALREADY
GOT DATA ON HUNDREDS OF
THOUSANDS OF PEOPLE THAT CAN
IMMEDIATELY COME INTO THESE
SYSTEMS.
SO KUDOS FOR GETTING THIS
TOGETHER.
THIS HAD TO HAVE BEEN A MONSTER
TO JUST GET THE ARMS WRAPPED
AROUND.
SO THANKS TO NHGRI FOR TAKING
THE LEADERSHIP ON THIS.
>> TERI: THANK YOU, NANCY.
REALLY THE THANKS NEED TO GO TO
MY COLLEAGUE NEPHI WHO WAS THE
LEADER IN THIS AND DID A
FABULOUS JOB DEVELOPING IT, WE
HOPE TO ATTRACT HIM BACK WHEN
GRASS IS A LITTLE GREENER.
>> JEN: TIM, I THINK YOU HAD A
QUESTION?
>> TIM: YEP.
I AGREE WITH ALL THESE COMMENTS.
IT'S IMPRESSIVE AND I REALLY
APPRECIATE THE PRESENTATION
TODAY.
ONE CONCERN I DO HAVE IS HOW
MOVING REVIEW TO CSR WILL
IMPACT SOMETHING LIKE THIS
WHERE FOR EXAMPLE, SECURITY IS
GOING TO BE A HUGE
CONSIDERATION AND THAT'S NOT
SOMETHING THAT I THINK THE
STANDARD CSR PANEL IS GOING TO
BE CAPABLE OF EVALUATING AND
REVIEWING PLANS FOR.
I DON'T, IT'S MORE OF A
COMMENT, I GUESS THAN A
QUESTION, BUT JUST WANT TO FLAG
THAT, THAT'S SOMETHING THAT, I
THINK, I HAVE CONCERNS THAT THE
STANDARD CSR PANEL MAY NOT DO
SERVICE TO AN RFA LIKE THIS.
>> TERI: LET ME ASK BEFORE YOU
COMMENT, THE SECURITY CONCERN
WOULD BE ABOUT ACTUAL PATIENT
DATA OR ABOUT SIMULATED DATA?
>> TIM: IT SEEMS IF YOU ARE
GOING TO SERVE UP PATIENT DATA,
THE SECURITY CONCERNS BECOME
QUITE STRONG AND IT WOULD BE,
YOU KNOW, PRUDENT TO EVALUATE
THAT ON SIMULATED DATA.
>> TERI: EXCELLENT.
YES.
GO AHEAD.
>> JEN: YES, I JUST WANTED TO
STEP IN, SORRY, DIDN'T MEAN TO
INTERRUPT YOU, THAT MOVING TO
CSR DOES NOT MEAN THAT IT WILL
NOT GET SPECIAL EMPHASIS PANELS.
SO THEY WILL CONDUCT SPECIAL
EMPHASIS PANELS.
AND IN FACT, THEY, YOU KNOW,
REMAINS TO BE SEEN EXACTLY HOW
IT ALL WORKS TOGETHER.
BUT THEY WILL CONSULT WITH US
ON, YOU KNOW, WHAT TYPE OF
EXPERTISE IS NEEDED FOR REVIEWS
AND SO FORTH.
SO NOT EVERYTHING WILL BE GOING
TO STANDING PANELS.
I JUST WANT TO CLARIFY THAT.
>> I WAS GOING TO SAY THAT, I
ELUDED TO THAT IN MY
PRESENTATION, IT WILL BE
IMPORTANT FOR US TO FIGURE OUT
HOW TO WORK WITH CSR AS A
PARTNER TO MOVE THESE TYPES OF
INITIATIVES FORWARD
PARTICULARLY WHEN WE ARE
PUSHING INTO THESE NICHE AREAS.
WE AREN'T ALONE IN THIS, IT
WILL HAVE TO BE DONE AT THE
NIH-WIDE LEVEL.
I THINK THAT'S GOING TO BE
SOMETHING AND AGAIN, I SORT OF
ELUDED TO FOR COUNCIL TO WORK
WITH AS WE START TO COME BACK
WITH SOME OF THE FIRST NOFO'S,
FIRST FUNDING PLANS COMING OUT
OF SOME OF THIS NEW MODEL.
I THINK WE WILL GET THERE, I DO
WANT TO STRESS JEN'S POINT IT'S
NOT GOING TO BE LIKE THEY ARE
ALL GOING TO STANDING STUDY
SECTIONS BUT IT'S ALSO GOING TO
BE IMPORTANT FOR US INTERNALLY
AND THEN ALSO IN PARTNERSHIP
WITH COUNCIL WHICH IS WHY I'M
STRESSING IT NOW TO WORK
THROUGH HOW DO WE WORK THROUGH
THIS PLACE AND GET CSR TO THAT
POINT, BECAUSE I THINK THEY ARE
DEDICATED TO DOING IT BUT IT'S
NOT LIKE THEY ARE GOING TO
INSTANTANEOUSLY BE ABLE TO
ABSORB THE EXPERTISE OF 27
INSTITUTES SORT OF APPROACHES.
SO LONG TERM, WE WILL GET THERE.
BUT IN THE SHORT-TERM IT WILL
BE SOMETHING WE HAVE TO PUSH ON
AND WE WILL BE WORKING WITH
COUNCIL TO MAKE SURE WE ARE
STILL GETTING WHAT WE WANT OUT
OF THESE KEY INITIATIVES WE ARE
PUTTING FORWARD.
>> TIM: THANK YOU.
>> TERI: ARE THERE OTHER
COMMENTS FROM COUNCILMEMBERS?
IF NOT, I THINK I TURN IT BACK
TO YOU.
>> JEN: YEAH, I THEY WE NEED A
MOTION TO APPROVE.
GOT ONE FROM BRUCE, AND SECOND,
LOOKS LIKE WE GOT A COUPLE
SECONDS.
WE WILL DO HANDS FIRST.
ALL IN FAVOR?
THANK YOU.
SO NOBODY AGAINST, AND NOBODY
ABSTAINING, YOU ARE ALL SET.
AND THEN COUNCILMEMBERS, I'M
GOING TO ASK YOU TO CLICK BACK
INTO ECB IN THE OPEN SESSION
AGENDA AND SCROLL DOWN TO THE
CLINICAL DATA ECOSYSTEM FOR
GENOMICS AND REGISTER YOUR VOTE
IN THE SYSTEM.
AND WHILE THEY ARE DOING THAT,
I'M GOING TO INVITE ROB UP TO
TALK ABOUT THE NEXT CLEARANCE,
THE GENOMIC RESEARCH CAPACITY
BUILDING CENTERS.
>> ROB: THANK YOU FOR ALLOWING
ME TO SPEAK TO YOU ABOUT THIS
NEXT CONCEPT.
I WANT TO SAY THANK YOU TO
LAINEY AND WAYNE.
AND SHOUT OUT TO MY PARENTS.
WE CHANGED THE TIME.
I DON'T KNOW IF THEY WILL BE
WATCHING ME, IF THEY WATCH ME
IN A FUTURE VIDEOCAST, SHOUT
OUT TO MY FAMILY IN PERU.
[KIM JACOBI MYERS]
>> I HAD A SUDDEN REALIZATION,
I DIDN'T DO THIS AND COULD HAVE
CALLED MY MOM AND ME TALKING
FOR 30 MINUTES.
>> ROB: WE ARE FEDERAL
OFFICIALS BUT WE ARE PEOPLE,
THE PEOPLE BEHIND US THEY CARE
THAT THE SCIENCE BEHIND THIS
MOVES FORWARD.
THAT'S PART AND PARCEL WHAT
THIS CONCEPT IS ABOUT.
HOW DO WE ENSURE WE ARE AT THE
FOREFRONT OF GENOMICS AND
EVERYONE ACROSS THIS
INSTITUTION AND INSTITUTION
TYPES COULD BE PART AND PARCEL
OF THAT PATH FORWARD.
IT'S THE GENOMICS RESEARCH
CAPACITY BUILDING.
DRIVING OPPORTUNITIES FOR THE
DEVELOPMENT OF INNOVATIVE
RESEARCH, EXPANDING TRAINING
OPPORTUNITIES AND THEN
STRATEGIC PARTNERSHIPS AND
ALLIANCES, NOT ONLY WITH
INSTITUTIONS BUT ALSO WITH
COMMUNITY MEMBERS AND GROUPS.
WHAT'S THE CONCEPT IN GENERAL?
OUR FWOEL IS TO ENHANCE
GENOMICS RESEARCH AND RESEARCH
CAPACITY.
SO WE ARE TRYING TO ENSURE
INSTITUTIONS THAT HAVE LESS
THAN $50 MILLION PER FISCAL
YEAR, LESS THAN $25 MILLION PER
YEAR IN TOTAL COST RO1 FUNDING
HAVE OPPORTUNITIES TO GET LARGE
SCALE GENOMICS RESEARCH FUNDING
TO EXPAND THE RESEARCH THEY ARE
DOING AND ALSO TRAIN NEXT
GENERATION OF RESEARCHERS.
THE MECHANISMS IN RM1,
COLLABORATIVE PROGRAM GRANT FOR
MULTI-DISCIPLINARY TEAMS WITH
THE IDEA THERE WILL BE ONE
SCIENTIFIC IDEA ACROSS THE
ENTIRE CENTER WITH DIFFERENT
INVESTIGATORS THAT ARE WORKING
TOGETHER TO MOVE THINGS FORWARD.
THESE CENTERS WILL HAVE FOUR
SPECIFIC COMPONENTS.
THE BASE OF IT WILL BE THE
PRIMARY RESEARCH PROJECT WHICH
COULD BE 2-3 PROJECTS PER TEAM
A DIRECTION THE ONE OVERARCHING
QUESTION.
AND WE ARE BEING FAIRLY OPEN
ABOUT WHAT THAT QUESTION COULD
BE AN THE APPROACHES THEY WOULD
LIKE TO TAKE WITH IT.
ADDITIONALLY, WE WANT TO ENSURE
THERE'S A COMMUNITY ENGAGEMENT
CORE.
AT THE HEART OF IT WE WANT TO
MAKE SURE THAT THE WORK BEING
DONE COMES BACK AND TOUCHES THE
COMMUNITY.
AND ALSO THAT THE COMMUNITY IS
AWARE OF WHAT'S HAPPENING IN
THAT IVORY TOWER.
LIKEWISE, THERE NEEDS TO BE A
TRAINING CORE BECAUSE THIS IS A
PATHWAY TO SEE OPPORTUNITIES IN
SCIENCE AND RESEARCH.
LASTLY, SINCE IT'S A FAIRLY
LARGE CENTER PROGRAM THERE
SHOULD BE COLLABORATION CORE
WITHIN THAT CENTER.
SO, THE POTENTIAL CENTER
FORMATION COULD GO A NUMBER OF
WAYS.
THIS IS ONE VERSION OF WHAT A
CENTER COULD LOOK LIKE.
YOU COULD BE A SOUTHEASTERN
GENOMICS CAPACITY CENTER WHERE
THERE'S THREE DISTINCT
INSTITUTIONS WORKING TOGETHER
WITH PI'S AT THREE DISTINCT
PLACES.
BUT STILL THAT ONE OVERARCHING
TYING TOGETHER SCIENTIFIC GOAL.
OR YOU COULD HAVE CENTER WHERE
IT'S TWO INSTITUTIONS BUT TWO
OF THE INVESTIGATORS ARE FROM
THE SAME INSTITUTION.
THE IDEA PRIMARILY HERE IS THAT
THE INSTITUTION TYPES ARE
INSTITUTIONS THAT HAVE
HISTORICALLY NOT BEEN HEAVILY
FUNDED BY NIH BUT THIS IS A
CHANCE FOR THEM TO BE PART OF
THE GENOMICS COMMUNITY.
ESSENTIALLY THE CAPACITY
CENTERS WILL SERVE AS A NEXUS
POINT TO ENSURE THAT RESEARCH
THAT'S HAPPENING ACROSS NHGRI
CAN BE DISSEMINATED TO MORE AND
MORE INSTITUTIONS AND ALSO
PROVIDE TRAINING OPPORTUNITIES.
NHGRI INTENDS TO COMMIT UP TO
$45 MILLION IN TOTAL COSTS FROM
2026-2031 AND FUND UP TO THREE
CAPACITY BUILDING CENTERS,
DEPENDING ON THE AVAILABILITY
OF FUNDS.
I GRANT, THIS IS MUCH VAGUER
THAN THE PREVIOUS PROPOSAL
BECAUSE WE ARE STILL WORKING
THROUGH ALL THE DETAILS.
SO WE WOULD REALLY LIKE TO HEAR
YOUR COMMENTS OR THOUGHTS YOU
MIGHT HAVE ABOUT HOW WE CAN
ENSURE THIS PROGRAM MEETS ITS
GOAL.
THAT GOAL IS ENSURING THAT
REGARDLESS OF THE ZIP CODE,
INDIVIDUALS CAN BE PART OF THE
REVOLUTION OF GENOMICS AND
ENSURING INCREASED LIVELIHOODS.
SO WITH THAT, I'M GOING TO PASS
THE MIC TO OUR AMAZING JEN
TROYER WHO IS GOING TO ASK YOU
ALL FOR COMMENTS AND QUESTIONS.
>> JEN: OKAY, WOULD SOMEBODY
LIKE TO START US OFF?
-- CASEY, WOULD YOU LIKE TO
START US OFF?
>> CASEY: YES.
I JUST HAD TO COME OFF MUTE.
I'M REALLY EXCITED TO SEE THIS
CONCEPT BEING PUT FORWARD.
I HAD A COUPLE OF THOUGHTS.
AND I LIKE THE FLEXIBILITY OF
IT, JUST TO START OUT WITH.
I LIKE THE FLEXIBILITY OF
HAVING ONE TO THREE
INSTITUTIONS.
IT COULD BE ONE INSTITUTION
VERSUS THREE INSTITUTIONS THAT
ARE PART OF A REGION, FOR EXER
EX.
EXAMPLE.
AND YOU ARE KIND OF BUILDING
SUB COMMUTITY WITHIN THE
GENOMICS ENVIRONMENT.
I DID HAVE A QUESTION ABOUT HOW
THE LOW-RESOURCE DEFINITION
WAS, HOW THAT WAS DEFINED?
LIKE IS THERE A FLOOR FOR HOW
IT IS BEING DEFINED FOR PEOPLE
TO BEEL NL?
-- BE ELIGIBLE?
IS THERE A KIND OF CLEAR LACK
OF MEMBERSHIP WITHIN THE
GENOMICS QUESTION?
>> ROB: THAT'S A GREAT QUESTION.
WE ARE WORKING ABOUT WHO IS
TAKING PART IN LARGE RESEARCH
FUNDING OPPORTUNITIES BOTH
NHGRI AND NHGMS, SO THAT'S THE
RATIONALE OF HAVING A $50
MILLION CAP IN TOTAL COSTS FROM
NIH OVER THREE YEARS AND $25
MILLION IN TOTAL COSTS R01 OVER
THE THREE FISCAL YEARS.
WE WANT TO ENSURE THE FUNDSES
ARE GOING TO NOT THE SAME
INSTITUTIONS OVER AND OVER.
AND THAT ALL THE PARTICIPATING
COMPONENTS ARE INSTITUTIONS OF
THAT TYPE.
SO IN PREVIOUS PROGRAMMING
SOMETIMES THERE'S BEEN THIS
ELIGIBILITY REQUIREMENT BUT
THEN THERE WOULD BE
SUBCONTRACTS OF VERY LARGE
INSTITUTIONS.
WHICH, SORT OF DEFEATS SOME OF
THE PURPOSE OF TRYING TO ENSURE
THAT INVESTMENTS HAPPEN AT
SMALLER INSTITUTIONS.
>> CASEY: I SEE.
THANK YOU FOR CLARIFYING THAT.
FOR THE CAPACITY-BUILDING
ASPECT, THE FUNDS ARE WHAT'S
GOING TO FUEL THE CAPACITY
BUILDING AND THEN THERE'S
MECHANISMS WITHIN THE STRUCTURE
FOR ENABLING COMMUNITY
ENGAGEMENT, AS WELL AS
BROADENING CHANGE THROUGHOUT
THE INSTITUTION.
I'M ASSUMING ALSO THAT TRAINING
WOULD BE ALIGNED WITH THE
RESEARCH PROJECTS THAT ARE
BEING SUPPORTED BY IT AS WELL.
IT SEEMS LIKE THE STRUCTURE
MAKES SENSE.
I DID SEE THERE WAS SOME
EXISTING PROGRAMS ALSO THAT
WERE LISTED.
AND I WASN'T SURE IF THERE'S A
VISION FOR HOW IT WOULD ALIGN
WITH AN EXISTING PROGRAMS.
I WASN'T IS THERE HOW IT WOULD
ALIGN.
>> ROB: THE PLACE OF GREATER
INCORPORATION OF THE TWO
DIFFERENT GROUPS IS THROUGH
ANNUAL MEETINGS.
AND ALSO ENSURING THAT THERE'S
JUST GREATER DIALOGUE.
SO EVEN IN THE DEVELOPMENT OF
THIS NOTICE OF FUNDING
OPPORTUNITY, GREATER
INTERACTION WITH OTHER
DIVISIONS TO ENSURE AS WE
DEVELOP THIS FUNDING
OPPORTUNITY THAT THERE'S WIDE
UNDERSTANDING OF WHAT'S GOING
ON THAT DISSEMINATES TO ALREADY
FUNDED RESEARCH INVESTIGATORS
IN THOSE DIFFERENT DIVISIONS.
SO WE WANT TO ENSURE THIS
DOESN'T STANDOFF ON ITS OWN, OH
YEAH THIS IS THE CAPACITY
BUILDING WITHOUT INTERSECTIONS
FROM ELSI CENTERS OR FROM THE
CEGS BUT SHOULD BE PART AND
PARCEL 1HG OR 1IH APPROACH.
>> CASEY: THANK YOU, THAT'S THE
VIEW TO HAVE THIS PLAN FOR
DIFFERENT GROUPS TO GET
TOGETHER AND SHARE KNOWLEDGE,
KNOWLEDGE TRANSFER.
THANK YOU.
I THINK I WILL PASS IT TO NANCY.
>> NANCY: I JUST WANTED TO MAKE
SURE THAT YOU MIGHT LINK IN
WITH SOME OF THE RECENT AI
INITIATIVES THAT NHGRI, IN
PARTICULAR, HAS PUT FORWARD.
I THINK ONE OF THE THINGS THAT
NEEDS TO HAPPEN AS GENETICS
GETS BETTER DISTRIBUTED IS A
REMINDER THAT 50% OF PRACTICING
PHYSICIANS IN THE UNITED STATES
OF AMERICA HAVE NEVER HAD A
COURSE IN GENETICS, NOT AS
MEDICAL STUDENTS, NOT EVER.
SO THE UNDERSTANDING OF HOW TO
ORDER GENETIC TESTS, FOR
EXAMPLE, IS POOR.
AND WHEN PHYSICIANS BECOME
ENCOURAGED TO START DOING THESE
THINGS, THEY MAKE A LOT OF
MISTAKES.
AND WE HAD EMPLOYED A GENETIC
COUNSELOR FOR EXAMPLE, TO LOOK
OVERALL OF THE MEDICAL TESTS
ORDERED AT BUMC.
AND IT SAVED US JUST TONS OF
MONEY BECAUSE THE PHYSICIANS
WERE ORDERING THE WRONG TESTS,
A LOT OF THE TIME.
AND ORDERING WHAT WERE IN
EFFECT DUPLICATE TESTS THAT
THEY DIDN'T REALIZE WERE
DUPLICATE TESTS AND ALL KINDS
OF THINGS LIKE THAT.
I KNOW SOME OF THE AI EFFORTS
UNDER WAY ARE ACTUALLY DESIGNED
TO HELP DO THINGS LIKE THAT,
THAT COULD BE REALLY GREAT FOR
THESE GROUPS TO BE ABLE TO TAP
INTO FROM THE BEGINNING.
SO IT WAS A SPECIFIC SUGGESTION
THAT THE AMONG THE WAYS YOU
LOOK TO PARTNER WITH EXISTING
FUNDING IS ALSO IN THE AI
INITIATIVE.
BECAUSE I THINK THEY ARE SOME
FOSI?
(?) THINGS THAT WOULD BE AT
INSTITUTIONAL LEVELS THAT COULD
REALLY HELP IN THIS PARTICULAR
SET OF INSTITUTIONS THAT ARE
GOING TO BE A LOT MORE
COMMUNITY-BASED, IN SOME SENSE,
RATHER THAN UNIVERSITY RESEARCH
EXCLUSIVE KINDS OF INSTITUTIONS.
THAT MAY BENEFIT ESPECIALLY
FROM THE AI MATERIALS BEING
DEVELOPED FOR HEALTHCARE
CENTERS.
>> ROB: I THINK THAT'S AN
EXCELLENT POINT, NANCY.
ALSO I LIKE THE IDEA OF
FOCUSING ON PROVIDERS WHO MIGHT
NOT HAVE THAT GENOMIC TRAINING.
AND IF THAT COULD BE
POTENTIALLY PART OF THE
COMMUNITY ENGAGEMENT CORE.
SOMETIMES WE DON'T ALWAYS VIEW
THE PHYSICIAN CLASS --
>> NANCY: EXACTLY.
THE PHYSICIANS ARE A PART OF
THAT COMMUNITY.
THAT YOU WANT TO HEAR FROM.
AND GET INPUT FROM, BUT ALSO
THAT YOU WOULD LIKE TO BE ABLE
TO HELP WITH AUTOMATED TOOLS.
THANK YOU.
>> CASEY: I THINK TIM WAS THE
OTHER DISCUSSANT.
>> TIM: THIS IS WONDERFUL TO
SEE.
I ESPECIALLY LIKED SOME OF YOUR
COMMENTS ABOUT CONNECTING THIS
WITH EXISTING PROGRAMS.
I THINK IT WOULD BE VERY
NATURAL FOR THE CEGS MEETING TO
INCLUDE THESE AWARDS AS WELL
FOR EXAMPLE, OR SOMETHING ALONG
THOSE LINES.
THAT MAKES IT A PART OF THE
BROADER ECOSYSTEM AND I COULD
ENCOURAGE YOU TO THINK STRONGLY
ABOUT DOING THAT AND MAKING
THAT QUITE SEAMLESS AND QUITE
TRANSPARENT.
ALSO IN THE WRITTEN DOCUMENT
THERE'S SOME COMMENTS AROUND
BUILDING, MAKING THIS
RECRUITIVE AND BRING IN NEW
FACULTY HIRES.
ONE CONSIDERATION IS A
FIVE-YEAR TIMEFRAME ENOUGH FOR
THAT TYPE OF ACTIVITY GIVEN HOW
LONG IT COULD OFTEN TAKE TO
IDENTIFY ADVERTISE, FIND AND
SUPPORT NEW FACULTY MEMBERS.
YOU KNOW, I DON'T KNOW IF
THERE'S EVER POTENTIAL TO GO
PAST OR LONGER THAN FIVE YEARS
BUT YOU MIGHT THINK ARE THERE
WAYS TO SET THIS UP TO MAKE
THAT FACULTY OR RECRUITED AS
PART OF THIS, CAN BE MULTIPLE
YEARS OF SUPPORT OUT OF IT.
>> ROB: THAT'S AN EXCELLENT
POINT, TIM.
I WISH I HAD A MAGIC WAND FOR
FUNDING AND WE COULD DO IT FOR
TEN YEARS.
I KNOW IN THE RM1, IT'S OFTEN
THINKING THE 5-10 YEAR WINDOW,
PENDING THE SUCCESS HOW THIS
GOES THERE WOULD BE POSSIBILITY.
>> TIM: I THINK WHERE I'M GOING
IS ENCOURAGING WHAT DOES A
RENEWAL LOOK LIKE FOR THESE FOR
A SECOND SET OF FIVE YEARS,
WHAT WOULD SUCCESS LOOK LIKE
AND WHAT WOULD RENEWAL LOOK
LIKE?
I THINK IT'S THOSE SORT OF
RENEWED PROJECTS I THINK YOU
COULD HAVE OUT SIZED IMPACT.
>> JEN: BRUCE, I THINK YOU HAD
YOUR HAND UP?
>> BRUCE: YEAH, THANKS.
TWO THINGS.
ONE IS, IT STRIKES ME THAT
THERE COULD BE OPPORTUNITIES
HERE FOR PARTNERSHIPS WITH THE
ALL OF US RESEARCH PROGRAM.
WHICH I KNOW HAS STRONG
INTEREST IN SEEING USE OF THE
DATASETS BY INVESTIGATORS AS
WIDELY DISTRIBUTED AS POSSIBLE.
THE ADVANTAGE THERE IS THE COST
OF SEQUENCING IS ZERO FOR
PEOPLE THAT MIGHT WANT TO
ANALYZE THE DATA.
AND ONE COULD IMAGINE THAT
WOULD BE, ONE OF UNDOUBTEDLY
MANY RESOURCES THAT COULD BE
USED TO KIND OF HELP JUMP START
SOME OF THESE RESEARCH EFFORTS.
THE OTHER THING UNRELATED TO
THIS IS, I GUESS I COULD
IMAGINE THAT PART OF THIS COULD
INCLUDE WAYS OF TRAINING
INVESTIGATORS TO ACQUIRE SKILLS
THAT THEY MIGHT NOT CURRENTLY
HAVE BUT COULD ACQUIRE AND THEN
BECOME PLAYERS.
IMAGINE DEVELOPING ALMOST LIKE
CERTIFICATES OF COMPETENCY
PROGRAMS IN PARTICULAR AREAS OF
DATA ANALYSIS, FOR EXAMPLE,
THAT WOULD HELP PEOPLE REACH A
POINT WHERE THEY ACTUALLY COULD
BECOME INDEPENDENT BUT TO HELP
MENTOR THEM ALONG THE WAY TO
ACTUALLY ACHIEVE THAT.
>> ROB: I CONCUR.
>> CASEY: I HAD ANOTHER COMMENT
WHAT NANCY AND BRUCE BROUGHT
UP, LEVERAGING EXISTING
INFRASTRUCTURE.
I THINK ANOTHER PROGRAM TO
CONSIDER IS THE ABLE HEAD?
(?) PROGRAM, THEY HAVE SOME
INTERESTING MODELS TO
FACILITATE ONBOARDING WITH NEW
INFRASTRUCTURE AND THINGS LIKE
THAT, CONCIATORS PROVIDING
GUIDANCE AND GETTING ONBOARDED
IN EXISTING INFRASTRUCTURE.
I THINK SIMILAR STRATEGIES
EXIST WITH ANVIL.
IF THERE WERE WAYS TO DIRECTLY
CONNECT THESE CENTERS WITH
THESE KINDS OF PROGRAMS AND
SUPPORT OPTIONS ALSO IT WOULD
BE GREAT.
>> ROB: I CONCUR.
I THINK THE WAY THIS IS
SUCCESSFUL IS IF IT CONNECTS
FULLY TO THE ENTIRE GENOME
UNIVERSE, AS WELL AS ALL
OPPORTUNITIES ACROSS NIH LARGER.
SO WE HOPE TO MOVE FORWARD WITH
IT, WITH YOUR CONSENT.
BUT ALSO COME BACK AT REGULAR
INTERVALS AND GIVE YOU UPDATES
ABOUT HEY, THIS IS HOW WE ARE
DOING IT.
AND ALSO HOW COULD WE DO IT
POTENTIALLY BETTER, BECAUSE
IT'S AN EXPERIMENT, RIGHT?
>> JEN: GO AHEAD, JANE.
>> JANE: I THINK THE ONLY
PERSON WITH THE RAISE-HAND
FUNCTION IS NANCY, WHICH I
THINK IS PROBABLY APPROPRIATE.
JUST A COMMENT ABOUT FOLLOWING
UP ON KIND OF CONNECTING IT TO
OTHER GENOME INITIATIVES.
MAJOR COMMENT ABOUT FOLLOWING
UP ON CONNECTING IT TO ANOTHER
GENOME INITIATIVES, I DON'T
KNOW ABOUT THE REST OF THE
GROUP THAT TRAVELS BANG, IT'S
VERY BUSY BETWEEN SEPTEMBER AND
JUNE.
I WOULD ENCOURAGE YOU FOR
CAPACITY BUILDING AND EDUCATION
PURPOSES.
PEOPLE ARE BUSY DURING THE
SUMMERS, AT LEAST I AM, I THINK
IT'S TRUE FOR THE OTHER PEOPLE.
I THINK IT'S AN OPPORTUNITY TO
HAVE COURSES AND CONNECTIVITY.
>> ROB: THANK YOU.
>> JEN: ANY OTHER COMMENTS,
QUESTIONS OR SUGGESTIONS FROM
COUNCILMEMBERS?
ALL RIGHT, COULD I HAVE A
MOTION TO APPROVE?
GOT ONE.
AND THE SECOND, ALL RIGHT.
ALL IN FAVOR?
HOLD YOUR HANDS UP FOR A MINUTE.
ALL RIGHT, GOOD, THANK YOU.
LOOKS UNITED KINGDOM.
-- UNANIMOUS, WE WILL MOVE
ONTO VOTING IN ECB, FOR THE
GENOMIC RESEARCH CAPACITY
BUILDING.
IF YOU CAN REGISTER YOUR VOTE
THERE.
WHILE THEY ARE DOING THAT, I
THINK WHAT WE WILL DO NOW IS
TAKE A BREAK UNTIL 2:15 AND
THEN WE WILL COME BACK WITH THE
LAST CONCEPT CLEARANCE.
SO EVERYBODY STRETCH YOUR LEGS,
GET SOMETHING TO DRINK.
WE WILL SEE YOU IN WHAT IS IT
20 MINUTES?
A LITTLE OVER 20 MINUTES.
I'M CHECKING TO SEE IF JUDY AND
CASEY ARE BACK.
I KNOW BRUCE IS STILL ON HIS
OTHER CALL.
HI, CASEY.
WHILE WE ARE WAITING FOR JUDY
AND BRUCE TO GET BACK, WE WILL
TAKE CARE OF SOME OF THE
NON-VOTING BUSINESS WE ARE
REQUIRED TO DO DURING THESE
COUNCILS.
SO FIRST OF ALL, I'M GOING TO
-- OH, EVERYBODY IS HERE.
WONDERFUL.
I THINK WE WILL GO BACK TO THE
NON-VOTING THINGS LATER THEN,
IF ALEXANDER, IF YOU ARE READY.
WE WILL HAVE ZANDER COME UP.
ARE YOUR PARENTS READY?
[LAUGHTER]
ANCIENT DNA FOR MODERN
GENOMICS, TAKE IT AWAY.
>> ALEXANDER: THANKS, JEN.
HAPPY TO PRESENT THIS IDEA.
ANCIENT DNA FOR MODERN
GENOMICS, WITH JYOTI DAYA, DAVE
KAUFMAN AND ISMAIL SAFI.
IF YOU HAVE BEEN PAYING
ATTENTION TO THE OTHER NEWS,
THE DIRE WOLFE HAS BEEN
RESURRECTED FROM EXTINCTION, OR
SO CLAIMED.
ANCIENT DNA FOR A
40,000-YEAR-OLD SKULL --
>> CAROLYN: ALL RIGHT, EVERYONE
SIT TIGHT.
WE LOST POWER.
COUNCILMEMBERS CAN YOU HEAR US?
>> YES, WE CAN STILL HEAR YOU.
>> CAROLYN: OKAY, THEY CAN
STILL HEAR US.
>> WE ALSO SEE THE DIRE WOLFE.
>> CAROLYN: OBVIOUSLY WE HAVE
GENERATOR POWER.
BUT THERE WAS A HUGE SOUND OF
EVERYTHING TURNING OFF IN THE
ROOM.
GIVE US A SECOND TO REGROUP.
WE DO HAVE POWER RAINS AND
THUNDERSTORMS OUTSIDE.
THAT COULD BE CONTRIBUTING.
>> I JOKED EARLIER WOULD BE
STRUCK DOWN DURING THIS
PRESENTATION.
>> CAROLYN: IT SEEMS WE ARE
ABLE TO RESUME, THE VIDEOCAST
IS STILL GOING.
WE CAN ALL SEE.
IT'S GOING TO GET HOT IN HERE
IF THE AIR CONDITIONER DOESN'T
COME BACK ON, BUT WE WILL DEAL.
GO AHEAD, ZANDER, YOU CAN
CONTINUE.
OKAY, ALEXANDER, TAKE IT AWAY.
>> ALEXANDER: EXCITING.
AS I WAS SAYING, ANCIENT DNA
FROM A 40,000-YEAR-OLD SKULL
AND 10,000-YEAR-OLD TOOTH FROM
A DIRE WOLF WAS USED TO
INTRODUCE VARIANTS IN THE WOLF
GENOME RESULTING IN TWO PUPS
BEING BORN.
ALTHOUGH THESE PUPS ARE NOT
DIRE WOLFS IT DOES DEMONSTRATE
WE ARE NOW IN THE POSITION TO
UNDERSTAND THE E FENGTS OF
ANCIENT DNA VARIANTS ON THE
FUNCTION AND BIOLOGY OF
GENOMES, NOT ONLY IN VITRO BUT
ALSO IN VIVO.
NOW WHEN IT COMES TO ANCIENT
HUMAN DNA AND FOR OUR PURPOSES,
WE ARE CALLING ANYTHING OLDER
THAN 500 YEARS, ANCIENT, THE
"NEW YORK TIMES" ASKED LAST
YEAR IF THE FUTURE OF MEDICINE
IS HIDDEN IN ANCIENT DNA.
THIS WAS SPURRED BY A SERIES OF
PAPERS THAT SHOWED THAT
MIGRATING POPULATIONS IN REGION
WHEN THEY BRING IN NEW GENETIC
VARIANTS THEY CAN BE SUBJECT TO
SELECTION BASED ON CHANGES AND
DIET AND LIFESTYLE.
WHICH UNDER CURRENT CONDITIONS
CAN LEAD TO INCREASED DISEASE
RISK.
SO FOR EXAMPLE, ONE HYPOTHESIS
IS IN EURO ASIA, THEY STARTED
CONSUMING LARGE AMOUNTS OF RAW
DAIRY PRODUCTS WHICH NOT
SURPRISINGLY LED TO IMMUNE
FUNCTION FOR INCREASED RISK FOR
AUTOIMMUNE DISEASE.
ANCIENT DNA CAN POTENTIALLY
TELL US SOMETHING ABOUT MODERN
DISEASE BIOLOGY.
NOW WE ALL KNOW HOW IMPORTANT
IT IS TO SAMPLE BROADLY GENETIC
VARIATION FROM ACROSS
POPULATIONS AND THIS IS
SOMETHING WE OUTLINED IN OUR
2020 STRATEGIC VISION.
NAZ BECAUSE GENETIC EFFECTS
FOUND IN ONE POPULATION DON'T
NECESSARILY CARRY OVER TO OTHER
POPULATIONS, THIS COULD BE DUE
TO DIFFERENCES IN ALLELE
FREQUENCY AND LOCAL AND
DEMOGRAPHIC FACTORS.
WE CAN HARNESS THE EFFECTS OF
EVOLUTION TO GIVE US BETTER
INSIGHTS IN GENOME BIOLOGY.
ALTHOUGH WE CAN LEARN A LOT
FROM EXISTING POPULATIONS AND
SPECIES, THERE IS STILL MORE WE
CAN LEARN FROM POPULATIONS THAT
NO LONGER EXIST AND FROM
SPECIES THAT ARE MORE CLOSELY
RELATED TO HUMANS LIKE SOME OF
OUR EXTINCT HOMINANT COUSINS.
WE THINK IT'S IMPORTANT TO
RESEARCH ESPECIALLY IF IT HAS
IMPLICATIONS FOR UNDERSTANDING
MODERN GENOMES AND CONTEMPORARY
HUMAN DISEASES.
BUT JUST LIKE DNA FROM MODERN
HUMAN POPULATIONS, DNA FROM
ANCIENT HUMAN SOURCES IS
GEOGRAPHICALLY BIASED.
MOST EXISTING DNA DATA THAT'S
BEEN PUBLISHED COMES FROM
WESTERN EURO ASIA, BY THE ALLEN
ANCIENT DNA RESOURCE SHOWING
MOST, ABOUT 79% OF IT COMES
FROM EUROPE AND RUSSIA.
AND IMPORTANTLY, THIS IS NOT
BECAUSE OF THE AVAILABILITY OF
SAMPLES, THERE ARE THOUSANDS OF
SAMPLES SITTING IN COLLECTIONS
IN MUSEUMS AROUND THE WORLD,
REALLY DUE TO DISTRIBUTION AND
DEPLOYMENT OF RESOURCES, WHERE
WE PUT OUR MONEY AND OUR EFFORT.
THIS MEANS ANY RELEVANT
INSIGHTS YOU GET INTO THE
BIOLOGY OF DISEASES OR OTHER
TRAITS COMING FROM ANCIENT DNA
DATA MAY BE APPLICABLE ONLY TO
SOME POPULATIONS.
ADDITIONALLY MOST OF THE
PUBLISHED DATA SO FAR HAS BEEN
GENERATED BY TARGETING ABOUT
ONE MILLION NON RANDOM SNPS IN
THE GENOME.
THIS IS THE ANALOGY AND
INFERENCES YOU CAN DO ABOUT
THINGS LIKE SELECTION OR
INTERFWRETION INTO HUMAN
GENOMES.
AND TODAY HAS REALLY BEEN THE
SEQUENCING COSTS THAT HAVE BEEN
LIMITING IN THIS EFFECT,
ESPECIALLY WITH CONTAMINATION,
BUT THIS IS NO LONGER A BARRIER.
WHAT WE DO NEED IS A WAY TO
OVERCOME BOTH THE GEOGRAPHIC
SAMPLING BIAS AND GENOME
COVERAGE BIAS FOR ANCIENT DNA
DATA AND MAKE IT AVAILABLE TO
THE RESEARCH COMMUNITY.
LAST OCTOBER WE PUT TOGETHER A
WEBINAR ON ANCIENT GENETIC
CLUES INTO MODERN HUMAN DISEASE.
WE BROUGHT TOGETHER A GROUP OF
ANTHROPOLOGISTS, POPULATION
EVOLUTIONARY MEDICINISTS TO
DISCUSS THE STATE OF THE FIELD.
SOME KEY TAKE AWAYS AND HIGH
LEVEL RECOMMENDATIONS FROM THE
PANELISTS INCLUDED THAT
RESEARCHERS SHOULD ENGAGE WITH
LOCAL COMMUNITIES EARLY ON IN A
PROJECT TO DETERMINE COMMUNITY
RESEARCH INTERESTS AND THEIR
PRIORITIES AND WHETHER THEY
ALIGN WITH THOSE OF
INVESTIGATORS AND FUNDERS.
AND THAT INVESTIGATORS IN THE
GLOBAL SOUTH AND LOW AND MIDDLE
INCOME COUNTRIES MAY LACK THE
NECESSARY RESOURCES TO BE EQUAL
PARTNERS IN IDEALLY FUTURE
PROJECTS WOULD INVOLVE CAPACITY
BUILDING FOCUSING ON
INFRASTRUCTURE OR WORKFORCE
DEVELOPMENT.
AND THAT STEPS SHOULD BE TAKEN
TO PREVENT THE GAP IN THE
REPRESENTATION OF ANCIENT DNA
FROM GLOBAL POPULATIONS FROM
WIDENING FURTHER THAT MAY
EXACERBATE DISPARITIES THAT MAY
EXIST AND POTENTIAL BENEFITS
AND APPLICATIONS SHOULD BE
PRESENTED IN A MEASURED AND
RESPONSIBLE MANNER TO
PARTICIPATING COMMUNITIES AND
THE PUBLIC.
THERE'S A LOT OF INTEREST AND
ATTENTION IN DNA RESEARCH AND
IT'S SENSATIONALIZED SO WE HAVE
A DUTY TO PRESENT THIS RESEARCH
IN A RESPONSIBLE MANNER.
NOW GIVEN ALL THAT WE PROPOSE A
PROGRAM ANCIENT DNA FOR MODERN
GENOMICS WHOSE BROAD GOALS
INCLUDE TO SURVEY AND IDENTIFY
SOURCES OF DNA FROM ACROSS THE
GLOBE, ENGAGING AND PARTNERING
WITH LOCAL INVESTIGATORS AND
COMMUNITIES.
ESTABLISHING ETHICAL AND
REGULATORY FRAMEWORK FOR
COLLECTING SAMPLES GENERATING
SEQUENCES AND SHARING DATA.
GENERATE HARMONIZE HIGH QUALITY
WHOLE GENOME ANCIENT DNA DATA
FROM NEW AND EXISTING SOURCES
SAMPLING GLOBAL GENETIC
DIVERSITY, CREATE CENTRALIZED
FEDERATED DATA RESOURCE AND
SUPPORT INDIVIDUAL RESEARCH TO
ADDRESS THE BIOLOGY,
EPIDEMIOLOGY OR EVOLUTION OF
DISEASE AND HEALTH-RELATED
TRAITS.
THE STRUCTURE OF THIS PROGRAM
WOULD INVOLVE THREE COMPONENTS.
A COORDINATION CENTER, UM1 DATA
PRODUCTION, U24 AND SERIES OF
RESEARCH PROJECTS, U01'S THAT
WOULD ADDRESS SPECIFIC
SCIENTIFIC QUESTIONS USING THE
ANCIENT DNA RESOURCE.
TODAY WE ARE ONLY SEEKING
CLEARANCE FOR THE FIRST TWO
COMPONENTS OF THE PROGRAM.
COORDINATION CENTER AND DATA
PRODUCTION CENTER.
THE INDIVIDUAL RESEARCH
PROJECTS WOULD COME TO COUNCIL
AT A LATER DATE FOR CLEARANCE
AND HOPEFULLY BY IT THAT TIME
THAT WOULD ALSO INVOLVE THE
PARTICIPATION OF OTHER NIH
INSTITUTES.
THE FIRST COMPONENT COMMUNITY
ENGAGEMENT AND COORDINATION
CENTER WOULD BE RESPONSIBLE
WORKING WITH LOCAL COMMUNITIES
TO IDENTIFY EXISTING AND NEW
SOURCES OF ANCIENT DNA THAT
MEET ESTABLISHED ETHICAL
FRAMEWORK FOR DATA SHARING AND
SOVEREIGNTY.
PROVIDE OVERALL OVERSIGHT AND
COORDINATION OF PROGRAM
ACTIVITIES ACROSS ALL
COMPONENTS.
DO THIS BY COORDINATE OUTREACH
TO INTERNATIONAL PARTNERS,
RESEARCH COLLABORATORS AND
PARTICIPANT COMMUNITIES WITH
THE LARGER GOAL OF CREATING A
GLOBALLY INCLUSIVE AND
REPRESENTATIVE ANCIENT DNA
RESOURCE.
THEY WOULD DETERMINE THE
INTEREST AND PRIORITIES OF
LOCAL COMMUNITIES WITH RESPECT
TO GENERATION OF SHARING OF
ANCIENT AND HISTORICAL DNA AND
DESIGN AND IMPLEMENT TRAINING
FOR LOCAL RESEARCHERS IN THE
GENERATION AND USE OF ANCIENT
DNA DATA.
OVERALL WE WANT TO BE ABLE TO
IDENTIFY SAMPLES OLD AND NEW
FROM THE AROUND THE WORLD AND
FILL IN GAPS AND DO THIS IN AN
ETHICAL AND NON EXTRACTIVE
MANNER.
THE SECOND COMPONENT OF DATA
GENERATION AND RESOURCE CENTER
WOULD BE RESPONSIBLE FOR
PRODUCING THE HIGH-QUALITY
GENOMES FROM A PROVED ANCIENT
DNA SOURCES AND HARMONIZE THAT
WITH EXISTING DATA TO CREATE A
CENTRALIZED DATA PORTAL.
WE WOULD DO THIS BY SEQUENCING
UP TO AT LEAST 10,000 DIPLOID
GENOMES REPRESENTING ANCIENT
AND HISTORICAL GLOBAL
POPULATIONS.
CREATE A CENTRALIZED HARMONIZED
DATA RESOURCE COMPATIBLE WITH
FEDERATED SYSTEM OF MIXED DATA
STORAGE AND USE LIMITATIONS AND
IMPORTANTLY NO MORE THAN 25
PERCENT OF THE NEW GENOME
SEQUENCE WOULD COME FROM
ANCIENT AND HISTORICAL WESTERN
EURASIAN POPULATIONS.
WE HOPE FOR THE COVERAGE THAT
CURRENTLY EXISTS FOR ANCIENT
DNA DATA AND DO THIS IN A WAY
THAT TAKES INTO ACCOUNT THE
GEOGRAPHY AND CHRONOLOGY OF
DIVERSITY THAT EXISTS TODAY AND
THAT HAS EXISTED IN THE PAST.
FUNDING AND TIMING.
WE ARE LOOKING TO START IN FY
'27.
A COORDINATION CENTER UM1 IN
THE DATA PRODUCTION CENTER U24
WILL START AT THE SAME TIME.
THEY WILL WORK TOGETHER TO
IDENTIFY EXISTING AND NEW
SOURCES OF ANCIENT DNA AND DATA
PRODUCTION WILL RAMP UP ACROSS
THE YEARS AS NEW SAMPLES ARE
IDENTIFIED.
THE INDIVIDUAL RESEARCH PROJECT
WOULD START IN THE SUBSEQUENT
FISCAL YEAR.
BUT IN ALL, IN TOTAL ACROSS ALL
FIVE YEARS AND ACROSS ALL THREE
COMPONENTS AND IF THE STARS
ALIGN, WE HOPE TO INVEST AROUND
$25 MILLION IN THE PROGRAM.
THAT IS IT.
AND I'M HAPPY TO TAKE QUESTIONS.
>> CAROLYN: JUDY, YOU WANT TO
LEAD US OFF?
>> SURE, I THOUGHT IT WAS ME
AND BRUCE, BUT I'M GETTING
CONFUSED.
I THINK THE FUNDAMENTAL
RATIONALE FOR THIS INITIATIVE
IS OUTSTANDING.
I'VE ALWAYS BEEN A BIG BELIEVER
OF SOMEONE WHO STUDIES THE
GENETICS OF CHRONIC
INFLAMMATORY DISEASES THAT SOME
OF THE DIFFERENCES IN DISEASE
PREVALENCE THAT WE SEE IN
DIFFERENT POPULATIONS.
SO MODERN DAY DISEASES CLEARLY
HAVE THEIR ROOTS, I GUESS I
AGREE WITH THE "NEW YORK TIMES"
HEADLINES THAT SELECTION FACTOR
TO HISTORICALLY SIGNIFICANT
PATHOGENS PROBABLY PLAY A KEY
ROLE IN DRIVING MODERN DAY
CHRONIC DISEASES.
I THINK THE SCIENTIFIC
RATIONALE FOR THIS IS CLEARLY
OUTSTANDING.
AGAIN, I DID NOT LISTEN TO THE
WEBINAR FROM THE LAST OCTOBER
BUT I DID LOOK AT THE AGENDA.
AND I LOOKED AT THE FOLKS THAT
WERE INVOLVED IN THIS.
CLEARLY EPIDEMIOLOGY AND
UNDERSTANDING OF HISTORICAL
PATTERNS OF DISEASE, I THINK,
SHOULD INFORM SOME OF THIS.
AND SO, I THINK THAT'S PROBABLY
GOING TO BE WEIGHTED TO THE
COORDINATING CENTER TOGETHER
WITH THE SEQUENCING CENTER
WORKING TOGETHER ON THIS.
BECAUSE THIS IS LIKE TRYING TO
BOIL AN OCEAN A LITTLE BIT.
BEING STRATEGIC ABOUT THIS AND
REALLY BEING ONBOARD SO THAT
SAMPLE ACQUISITION CAN PROCEED
A PACE IN AN EFFICIENT WAY AND
MAKE SURE THE SEQUENCING CAN BE
DONE IN A TIMELY AND EFFICIENT
MANNER WILL BE ESSENTIAL.
I DID HAVE A QUESTION, KIND OF
GIVEN THE NEW POLICIES
REGARDING INTERNATIONAL
SUBCONTRACTS.
AND THAT MIGHT POTENTIALLY BE A
CHALLENGE FOR THE COORDINATING
CENTER OR THE SEQUENCING
CENTERS PRESUMING THEY ARE
PRIMARILY U.S. INVESTIGATORS.
THERE'S CLEARLY GOING TO BE A
KEY ROLE FOR ACQUISITION, AS
YOU SAID, THE RFA SAYS YOU
CAN'T BE MORE THAN 25% OF A
ALREADY WELL REPRESENTED
COHORTS.
CLEARLY AFRICA WILL BE
IMPORTANT.
I'M NOT REALLY AN EXPERT ON
NORTH AMERICA AND THE BERING
STRAIT SO CLEARLY THERE'S
PRESUMABLY THIS WAS ALL
DISCUSSED AT THE WEBINAR LAST
FALL.
AND THEN FINALLY, JUST
SOMETHING FOR DISCUSSION WITH
THE GROUP IS KIND OF THE
QUESTION PART WOULD NOT START
INTO FISCAL YEAR '28.
I JUST WONDER AND OBVIOUSLY THE
COORDINATING CENTER WILL BE
EXPERT ON THIS AND SEQUENCING
CENTER WILL BE EXPERT ON THIS.
BUT I THINK ASKING THE
QUESTIONS AND KIND OF
ANTICIPATING PROBABLY ANALYSES
SHOULD BE DONE SOONER RATHER
THAN LATER.
I UNDERSTAND KIND OF THE
OPERATIONAL REASONS WHY IT'S
BEING PROPOSED AND DONE THAT
WAY.
BUT IT DOES, IT'S SOMETHING
THAT SHOULD BE AT LEAST
CONSIDERED AND DISCUSSED.
SO THOSE ARE MY MAJOR THOUGHTS
WHEN I READ THIS.
>> ALEXANDER: QUICK COMPONENT,
WE HOPE BY THE TIME THIS COMES
OUT THAT WILL BE A NEW
MECHANISM IN PLACE FOR THE
PARTICIPATION OF OUR
INSTITUTIONS IN NIH-SUPPORTED
RESEARCH.
>> JEN: YEAH, SO IT IS
ANTICIPATED PERHAPS AS EARLY AS
SEPTEMBER, APPLICATIONS COMING
IN AFTER SEPTEMBER WILL HAVE A
MECHANISM BY WHICH WHAT WILL
HAPPEN, THERE WILL BE COMPANION.
SO IT WOULD COME IN AS ONE
APPLICATION BUT THE AWARDS GO
INDIVIDUALLY TO THE DIFFERENT
INSTITUTIONS.
EVENTUALLY THIS IS ACTUALLY
PROBABLY GOING TO ROLL OUT FOR
ALL THINGS THAT USED TO BE
SUBS, BUT IT'S STARTING WITH
FOREIGN.
WE DON'T ANTICIPATE THAT ALONE
WILL BE A PROBLEM NOW IF THERE
WERE COLLECTION OF COUNTRIES OF
CONCERN WHERE WE ARE NOT
ALLOWED TO PROVIDE FUNDING,
THAT WOULD BE DIFFERENT.
BUT FOR FOREIGN COMPONENTS WE
EXPECT THAT PROBLEM TO BE
SOLVED.
>> ALEXANDER: IN TERMS OF
IDENTIFYING SAMPLES TO
SEQUENCE, WE HOPE THERE'S A
CONVERSATION WITH THE
COORDINATING AND SEQUENCING
CENTERS WHICH SAMPLES WOULD BE
MOST VALUABLE, DEPENDING WHAT
KINDS OF QUESTIONS WE WANT
ANSWERED, RIGHT?
SO, I DON'T THINK THE LIMITING
FACTOR WILL BE THE SAMPLES,
IT'S HOW MUCH MONEY WE COULD
PUT TOWARDS SEQUENCING THE
SAMPLES AND THERE WILL HAVE TO
BE SOME DISCUSSION AND
TRADE-OFFS IN TERMS OF BREADTH
AND DEPTH OF THE SAMPLES AND
WHEN AND WHERE YOU GET THE
SAMPLES FROM.
>> JUDY: OKAY, THAT ALWAYS IS
AN ISSUE.
I WAS A LITTLE LESS CONCERNED
WHEN I SAW YOUR SLIDE, KIND OF
ON THE SEQUENCING CENTER BUDGET
BEING SUBSTANTIALLY LESS THAN
THE OUT YEARS BUT IT'S NOT A
TRIVIAL THING TO GET THE
SAMPLES.
>> ALEXANDER: I AGREE.
>> JEN: NANCY, DO YOU WANT TO
GO AHEAD?
>> NANCY: YEAH, SO I JUST HAD A
COUPLE OF OTHER THOUGHTS AND
COMMENTS.
ONE IS THAT, WHILE I CERTAINLY
AGREE THAT HAVING THE
COORDINATING CENTER, THE
COMMUNITY AND COORDINATING
CENTER AND SEQUENCING CENTER
GET STARTED FIRST, IT'S GOING
TO BE IMPORTANT TO HAVE A REAL
DIALOGUE WITH THE FULL
COMMUNITY OF SCIENTISTS WHO
ANTICIPATE USING THE DATA FOR
THINGS LIKE HOW YOU, THE FINAL
DECISIONS MADE ON HOW THE DATA
WILL BE REPRESENTED.
LIKE WHAT THE POSSIBILITY OF
STRUCTURAL VARIATION IS AN
IMPORTANT PART OF EVOLUTION AND
ADAPTATION.
IS MEANINGFUL AND REAL.
SO HOW WE CHOOSE TO REPRESENT
SEQUENCE VARIATION THESE DAYS
IS MORE COMPLEX.
THE SORT OF MORE GRAPHICAL
SORTS OF INTERFACES ALLOW US TO
PRESERVE MORE OF THAT
POTENTIALLY STRUCTURAL
VARIATION.
IT COULD TURN OUT TO BE
IMPORTANT FROM AN EVOLUTIONARY
PERSPECTIVE.
SO JUST A HEAD'S UP THAT THERE
ARE LIKELY TO BE AT LEAST A
SUBGROUP OF PEOPLE SEEKING A
MORE COMPLEX ORIENTATION THAN
MIGHT HAVE ORIGINALLY BEEN
CONSIDERED.
I WOULD PREDICT THIS DATABASE
WOULD GET VERY HEAVY USE.
HOW THE DATA GETS REPRESENTED
IS OF EXTREME INTEREST TO THE
SCIENTISTS DEVELOPING THE
ANALYTIC TECHNOLOGIES FOR
LOOKING AT THESE POPULATIONS
AND TRYING TO UNDERSTAND
ORIGINS AND ADAPTATIONS AND SO
FORTH.
SO I JUST THINK THERE HAS TO BE
A LOT OF COMMUNICATION AS THE
DATA START TO BE STORED.
BECAUSE YOU DON'T WANT
DECISIONS THAT CAN'T BE
READDRESSED WITHOUT GREAT
EXPENSE LATER, AS PEOPLE YOU
KNOW, TRY TO DO ANALYSES.
AND THE RELEVANT DATA AREN'T
THERE.
SO THAT'S ONE THING.
THE OTHER THING, THE OTHER
WORRISOME THING IS STARTING TO
HAPPEN IN SOME PLACES IS THE
LOCAL COMMUNITIES ARE NOT
ALWAYS IN AGREEMENT ABOUT WHO
HAS, WHO SHOULD HAVE THE SAY IN
WHAT HAPPENS TO LOCAL ANCIENT
DNA SAMPLES.
SO I THINK THAT WOULDN'T COME
AS A SURPRISE TO ANYBODY WHO
HAS DONE THIS COMMUNITY
RESEARCH.
BUT I THINK IT DOES ADD AN
ELEMENT OF POTENTIALLY OF TIME
TO THE COLLECTION OF OF
SPECIMENS BECAUSE THERE HAVE TO
BE ADJUDICATIONS ABOUT WHO ALL
HAS A SAY IN HOW THINGS GET
DECIDED.
I THINK AN AGGRESSIVE TIMELINE
IS A GOOD THING TO PURSUE.
BUT I THINK THERE'S, IT IS IN
SOME AREAS GOING TO BE
COMPLICATED ABOUT DECISION
MAKING ABOUT WHO GETS TO SAY,
WHO GETS THESE FINAL
SUGGESTIONS FOR HOW DNA COULD
BE USED.
I DON'T THINK THIS IS SOMETHING
THAT WOULDN'T HAVE COME UP IN
SOME OF THESE DISCUSSIONS.
IT'S JUST REMINDING EVERYBODY
THAT THE TIMELINES CAN GET
COMPLICATED FOR CERTAIN AREAS.
I'M SO GRATEFUL SOMEONE HAS
TAKEN THIS ON.
IT'S A HEAVY LIFT AND TAKES
EXPERTISE TO EVEN DEVELOP THE
CONCEPT FOR A PROPOSAL SO MY
HAT'S REALLY OFF TO THE GROUP.
I THINK IT IS LONG OVERDUE
BECAUSE PEOPLE HAVE BEEN
DESPERATE FOR THESE DATA FOR
SOME TIME.
I'M REALLY GLAD THAT NHGRI IS
TRYING TO TAKE A LEADERSHIP
ROLE HERE, I THINK IT'S A
REALLY GOOD THING.
THANKS.
>> ALEXANDER: A COUPLE THINGS
TO THINK ABOUT IT.
DURING THE FIRST YEAR, THE
COORDINATION AND DATA
PRODUCTION CENTER CAN DO SOME
OUTREACH TO THE RESEARCH
COMMUNITY ASKING THEM WHAT
THEIR INTERESTS AND PRIORITIES
ARE IN TERMS OF THE DATA SO THE
DECISION MAKING IS NOT INTERNAL
TO THE NETWORK ITSELF.
IT DOES INVOLVE THE LARGER
COMMUNITY.
SO THAT'S A GOOD THING TO
INCORPORATE EARLY ON.
SO THAT'S A BROADER
CONVERSATION.
IN TERMS OF ESTABLISHING NEW
RELATIONSHIPS AND WITH
DIFFERENT COMMUNITIES, I THINK
GIVEN THE SHORT TIMELINE WHAT
WE WOULD LIKE TO DO FOR THE
COORDINATION CENTER IS REALLY
LOOK FOR INVESTIGATORS THAT
HAVE ALREADY ESTABLISHED
RELATIONSHIPS AND NETWORKS WITH
DIFFERENT COMMUNITIES.
THEY HAVE THAT TRUST ALREADY.
SO WE CAN SORT OF HIT THE
GROUND RUNNING WITH THOSE
RELATIONSHIPS ALREADY THERE.
BUT IT MIGHT BE THE CASE THERE
MIGHT BE SOME REGIONS OR AGES
THAT THE RESEARCHERS IDENTIFY
AS CRITICAL AND THEY WILL NEED
TO ESTABLISH NEW RELATIONSHIPS
AND NEW NETWORKS.
THAT'S SOMETHING, ONCE THEY ARE
THERE, FUTURE PROGRAMS CAN THEN
WORK WITH THEM.
BUT I THINK USING ESTABLISHED
RELATIONSHIPS AND BUILDING NEW
ONES, I THINK WOULD BE VERY
HELPFUL FOR FUTURE PROJECTS AS
WELL.
>> JEN: GO AHEAD, BRUCE.
>> BRUCE: I THINK THIS IS A
REALLY FASCINATING AREA, AND
IT'S ONE I DON'T KNOW VERY MUCH
ABOUT.
SOME OF THESE POINTS MAY BE A
LITTLE BIT NAIVE.
FIRST OF ALL, IT STRIKES ME IN
A WAY YOU COULD CONCEPTUALIZE
THIS AS LOOKING AT THE PAN
GENOME IN THE FOURTH DIMENSION.
NAMELY A DIMENSION OF TIME.
AND I WONDER IN THE COURSE OF
WHERE SAMPLES ARE OBTAINED FROM
NOT ONLY IS IT IMPORTANT TO
LOOK AT GEOGRAPHICAL DIVERSITY,
BUT ALSO, THERE MUST BE
CLIMACTIC EVENTS, ICE AGE IS
ONE ONE WOULD WANT TO BE
LOOKING AT IN CONTEXT OF HUMAN
EVOLUTION.
I DON'T KNOW HOW FEASIBLE THIS
IS, THIS IS WHERE MY NAIVITY
WILL SHOW.
I THINK HUMANS HAVE CO-EVOLVED
WITH MICROORGANISMS.
I AM WONDERING IF THERE ARE
WAYS OF PARALLELING SOME OF THE
FINDINGS OF WAYS OF LOOKING AT
EVOLUTION OF MICROORGANISMS
THAT WOULD HAVE PROBABLY HAD A
BIG IMPACT ON HUMAN HEALTH OVER
THE COURSE OF THE AGES.
>> ALEXANDER: YEAH, SO ONE,
REASON WHY MOST OF THE
SEQUENCING HAS BEEN TARGETED IS
MUCH OF THE ANCIENT DNA HAVE
CONTAMINATION, MOSTLY MICROBIAL.
WE WILL SEQUENCE THAT WE WON'T
THROW AWAY BUT WILL BE THERE TO
ANALYZE IN TANDEM WITH THE
ANCIENT HUMAN DNA THAT'S A
RESOURCE WE CAN PRESENT TO THE
COMMUNITY.
>> JEN: KELLY?
>> KELLY: FOLLOWING A LITTLE
BIT UP ON WHAT BRUCE SAID AND
ALSO THE COMMENT ABOUT THE
DEFINITION OF ANCIENT GENOMES
BEING MORE THAN 500 YEARS, I'M
WONDERING IF IT WOULD MAKE
SENSE TO EVEN PULL THAT
TIMELINE IN, OR IF THAT'S A
HARD TIMELINE CUT-OFF FOR THE
RFA.
BECAUSE I THINK THERE'S
PROBABLY BEEN A LOT OF
EVOLUTIONARY PRESSURE OVER THE
LAST 400 YEARS AS POPULATIONS
HAVE MADE MAJOR MIGRATIONS
AROUND THE WORLD AND IMPACTED
OTHER POPULATIONS.
TO ACTUALLY BE ABLE TO GET A
TIME LINE OF WHEN THE SELECTION
PRESSURES OCCURRED, IT MIGHT BE
IMPORTANT TO PULL THAT TIMELINE
INTO MAYBE 200 YEARS.
ALTHOUGH WE OBVIOUSLY DON'T
WANT TO BE SEQUENCING.
YOU DON'T WANT TO SPEND YOUR
ENTIRE BUDGET SEQUENCING PEOPLE
FROM 200 YEARS AGO.
BUT I'M WONDERING IF PULLING
THAT IN A LITTLE BIT WOULD HELP
RESOLVE SOME OF THE QUESTIONS.
>> ALEXANDER: YOU MIGHT HAVE
NOTICED I SAID ANCIENT AND
HISTORICAL DNA.
WE CONSIDER HISTORICAL DNA
ANYTHING YOUNGER THAN 500 YEARS
SO THAT WOULD ALSO BE A TARGET.
THEN IT WOULD BE UP TO THE
NETWORK TO DETERMINE THE
BALANCE OF HOW MUCH HISTORICAL,
VERSUS HOW MUCH ANCIENT AND HOW
FAR BACK TO GO.
WITH THE HISTORICAL DNA, IT'S
MUCH EASIER TO SORT OF
COMMUNICATE WITH LOCAL
COMMUNITIES AND SORT OF
DETERMINE WHO HAS SORT OF
SOVEREIGNTY AND CLAIM OVER DATA.
ONCE YOU START GOING FURTHER
BACK IT BECOMES MUCH MORE
DIFFICULT.
IN SOME CASES THERE WILL BE
POPULATIONS THAT NO LONGER
EXIST, SO WHO IS SPEAKING FOR
THOSE POPULATIONS THAT HAVE
SORT OF MERGED AND MIXED AND
NOW EXIST IN A COMPLETELY
DIFFERENT FORM.
SO THOSE ARE THE TYPE OF
QUESTIONS THEY WILL HAVE TO
ADDRESS.
>> JEN: ANYONE ELSE WANT TO SAY
ANYTHING?
>> I WILL MAKE A SIDE COMMENT I
MADE AT MY OPENING REMARKS I
WAS AT A QUADRENNIAL GROUP, AND
THEY WERE LOOKING AT THE NATIVE
DOG.
THAT WOULDN'T BE PART OF THIS
PROJECT BUT I TOLD HER I WOULD
CONNECT WITH YOU, BECAUSE I
THINK IT WOULD BE INTERESTING
OUTSIDE THE NIH.
THINKING OF HAVING A LINKING OF
SOME OF THAT WOULD BE
INTERESTING.
>> ALEXANDER: HOST PATHOGEN
EVOLUTION, YOU COULD LOOK AT
EVOLUTION OF DOGS AND HUMANS,
DOGS AND CATS, TYPES OF
QUESTIONS I'M SURE INTEREST A
LOT OF PEOPLE.
>> JEN: ALL RIGHT.
MOTION TO APPROVE?
>> APPROVE.
>> JEN: AND SECONDED.
OKAY, ALL IN FAVOR, RAISE YOUR
HAND?
GREAT, LOOKS UNANIMOUS.
AND INTO ECB, IT'S THE ANCIENT
DNA FOR MODERN GENETICS CONCEPT.
THE SECOND ONE.
IF YOU COULD VOTE IN THERE AS
WELL.
THANK YOU, ZANDER.
>> ALEXANDER: THANK YOU,
EVERYONE.
>> JEN: I KNOW CAROLYN HAD A
SLIDE ABOUT ALL THE PEOPLE THAT
HELPED COUNCIL AT THIS MOMENT
BECAUSE I HAVE BEEN WATCHING
HIM, I WANT TO GIVE A SPECIAL
SHOUT OUT FOR BEN FOR TAKING
FANTASTIC NOTES FOR OUR MINUTES
FOR ALL OF THIS.
I THINK HIS FINGERS ARE MOVING
FASTER THAN THE SPEED OF LIGHT.
I THINK HE HAS CAPTURED
EVERYTHING THAT YOU GUYS HAVE
SAID.
>> [OFF MIC]
>> JEN: FOR YOUR PARENTS TO
WATCH, YES.
>> THANK YOU, AND MOM AND DAD,
IF YOU ARE WATCHING, I DID IT.
[LAUGHTER]
>> JEN: ALL RIGHT.
SO ONTO THE LAST BITS OF
BUSINESS.
FIRST OF ALL, OUR WORKING
GROUPS OF COUNCIL ARE REQUIRED
TO REPORT TO YOU ONCE A YEAR.
SO IN YOUR ECB YOU WILL FIND
REPORTS FROM TWO WORKING GROUPS
OF COUNCIL, THE GENOMIC
MEDICINE WORKING GROUP AND THE
GENOMICS AND SOCIETY WORKING
GROUP.
THESE ARE WRITTEN REPORTS THAT
YOU CAN READ AT YOUR LEISURE
AND THERE'S NO NEED TO VOTE.
HOWEVER, TERI AND NICOLE ARE
AVAILABLE IF YOU HAVE ANY
QUESTIONS FOR THEM ABOUT THESE
REPORTS.
ALL RIGHT.
FIVE SECONDS WITH NO QUESTIONS.
WE ARE GOING TO MOVE ON.
WE DO, WE ARE REQUIRED TO GET A
VOTE FROM YOU THAT YOU HAVE
SEEN AND REVIEWED THE TRIENNIAL
INCLUSION REPORT FOR FY
2022-2024.
WE HAVE COME TO COUNCIL EVERY
THREE YEARS WITH THIS REPORT TO
DOCUMENT THAT ALL THE STUDIES
THAT WE HAVE CONDUCTED HAVE
APPROPRIATE INCLUSION OF STUDY
SUBJECTS.
AND SO, I'M GOING TO ASK FOR A
MOTION TO APPROVE THE TRIENNIAL
INCLUSION REPORT.
AND I WANT TO GIVE A SHOUT OUT
TO JAMAL SCOTT, WHO IS, DO YOU
WANT TO-
>> JAMAL SCOTT, CHRISTINA CHANG
AND PEDIMINA, ARE THE ONE WHO'S
DID IT.
>> JEN: WE PUT IT IN THE
COUNCIL BOOK BUT THEY PULLED IT
ALL TOGETHER AND DID QUITE A
BIT OF WORK ON THAT.
CAN I HAVE A MOTION TO INCLUDE
THE INCLUSION REPORT.
FROM NANCY AND SECOND.
ALL APPROVE?
THANK YOU.
THAT'S UNITED KINGDOM AGAIN.
ALSO DO THAT IN COUNCIL BOOK.
WE WILL THEN MOVE ON TO THE
MOST EXCITING PART.
OUR ANNUAL REVIEW OF THE
STATEMENT OF UNDERSTANDING
BETWEEN COUNCIL AND NHGRI.
SO AGAIN, THIS COMES TO YOU ALL
ONCE A YEAR TO MAKE SURE THAT
WE ARE ALL IN AGREEMENT ON OUR
TERMS AND CONDITIONS OF WHAT
THE COUNCIL WILL APPROVE.
AND THIS WOULD HAVE COME TO
FEBRUARY BUT WE DIDN'T HAVE AN
OPEN SESSION IN FEBRUARY.
SO, THE STATEMENT OF
UNDERSTANDING BETWEEN THE
NATIONAL ADVISORY COUNCIL FOR
HOME GENOME RESEARCH AND THE
STAFF OF THE NATIONAL HUMAN
GENOME RESEARCH INSTITUTE.
OUR UNDERSTANDING IS THAT ALL
APPLICATIONS THAT HAVE
UNDERGONE THE INITIAL PEER
REVIEW WILL ALSO BE REVIEWED BY
COUNCIL.
EXCEPTIONS ARE APPLICATIONS FOR
FELLOWSHIPS, INTRAMURAL
RESEARCH THAT GOES ON AT NHGRI,
INTERAND INTRA AGENCY CONTRACTS.
AND THAT APPLICATIONS THAT HAVE
NOT BEEN IDENTIFIED FOR
INDIVIDUAL CONSIDERATION ARE
REVIEWED ON BLOCK.
THE FOLLOWING TYPES OF
APPLICATIONS WILL NOT BE IN THE
ON BLOCK VOTE BUT WILL ALWAYS
BE BROUGHT BEFORE YOU.
FOR INSTANCE, THE THINGS THAT
WE BROUGHT YESTERDAY.
THESE ARE ALL APPLICATIONS FOR
PROGRAM CONTRACTS, CENTERS AND
THE COOPERATIVE AGREEMENT OR U
COUNTERPARTS.
TRAINING, THE T32'S, AND ANY
COOPERATIVE AGREEMENT ON WHICH
NHGRI IS THE PRIMARY INSTITUTE.
WHERE WE ARE SECONDARY, IT WILL
GO TO THE COUNCIL OF THE
INSTITUTION THAT IS PRIMARY.
ALL APPLICATIONS THAT ARE
IDENTIFIED BY EITHER COUNCIL OR
STAFF TO BE OF SPECIAL CONCERN
OR POSING SPECIAL POLICY ISSUES.
SO WE WILL SOMETIMES IDENTIFY
THINGS THAT WE WANT TO BRING TO
YOU, BUT COUNCIL ALWAYS HAS THE
RIGHT TO RAISE ANY APPLICATION
THAT IS BEING CONSIDERED FOR
DISCUSSION.
EVEN IF NHGRI STAFF HAS NOT
DECIDED TO BRING THEM IN FRONT
OF YOU.
IF ANY APPLICATION HAS
PREVIOUSLY BEEN DEFERRED BY
COUNCIL FOR ADDITIONAL
INFORMATION OR RE-REVIEW, THAT
WOULD COME TO YOU.
ANY APPLICATIONS IN WHICH
UNRESOLVED CONCERNS HAVE BEEN
IDENTIFIED BY THE INITIAL
REVIEW GROUP, WITH RESPECT TO
ANIMAL WELFARE, HUMAN SUBJECTS,
ETHICAL ISSUES, RECOMBINANT
DNA, POTENTIAL BIO HAZARD OR
INCLUSION OR LACK OF WOMEN,
MINORS, MINORITIES IN CLINICAL
RESEARCH.
ANY APPLICATION FROM A FOREIGN
INSTITUTION FOR WHICH AN AWARD
IS PLANNED NEEDS TO HAVE A
FOREIGN JUSTIFICATION.
ANY APPLICATION WHERE THE TOTAL
NIH SUPPORT FOR THE PRINCIPAL'S
INVESTIGATOR ACTIVE ELIGIBLE
GRANTS ALREADY EXCEEDS $2
MILLION TOTAL COST AND THIS IS
BEING CONSIDERED BY FUNDING,
THIS IS NIH SPECIAL COUNCIL
REVIEW.
I WILL NOTE FOR THE AUDIENCE
WATCHING THAT FOR THIS YEAR,
FY' 25, THE REQUIREMENT TO DO
SPECIAL COUNCIL REVIEW WAS
WAIVED BY O.E.R., OR THE OFFICE
OF EXTRAMURAL RESEARCH.
WE AT NHGRI CONSIDER THAT
SPECIAL COUNCIL REVIEW IS NOT
NECESSARY FOR SUBJECTS OF
APPLICANTS CE IS, THEY ARE
ALREADY REQUIRED TO BE HIGHLY
INNOVATIVE AND TRANSFORMATIVE
WHICH IS THE REQUIREMENT, THAT
THE BAR THAT NEEDS TO BE PASSED
FOR SOMETHING TO MERIT BEING
FUNDED DESPITE BEING MORE THAN
$2 MILLION.
SO THEY ALREADY MEET THE SCR
CRITERIA AS UNIQUE RESEARCH
OPPORTUNITIES THAT ARE DISTINCT
FROM ANY OTHER AWARDS THAT THE
P.I. HAS ALREADY RECEIVED.
WE ALSO AGREE THAT ACTIVE GRANT
AWARDS THAT HAVE PROJECT PERIOD
END DATES WITHIN 90 DAYS OF THE
COUNCIL MEETING DON'T NEED TO
BE INCLUDED BECAUSE THOSE
AWARDS WOULD BE OVER BEFORE THE
RENEWAL AWARD WOULD START.
ALL RIGHT, SO THE FOLLOWING
OPTIONS ARE ALWAYS AVAILABLE
FOR COUNCIL FOR APPLICATIONS
THAT WE HAVE DISCUSSED.
YOU CAN CONCUR WITH THE
RECOMMENDATION OF THE INITIAL
REVIEW GROUP, OR THE I.R.G.
AND WITH OR WITHOUT ANY
RECOMMENDATIONS FOR CHANGES OR
FUNDING AMOUNT.
YOU CAN DEFER THE APPLICATION
FOR RE-REVIEW BECAUSE YOU FEEL
THERE WAS AN INADEQUATE INITIAL
REVIEW.
IF ASKED BY NHGRI STAFF, YOU
CAN RECOMMEND FOR HIGH OR LOW
PROGRAM PRIORITY, IN TERMS OF
FUNDING CONSIDERATIONS.
OR YOU CAN DEFER YOUR DECISION
AND ASK FOR MORE INFORMATION AT
A FUTURE MEETING.
SO THOSE ARE YOUR OPTIONS FOR
ANY VOTE THAT WE TAKE.
I WANT TO BRING SPECIAL
ATTENTION TO EXPEDITED COUNCIL
CONCURRENCE, OR EXPEDITED
REVIEW PROCESS BECAUSE IT IS
SOMETHING THAT WE PROBABLY WILL
USE A LITTLE BIT MORE AND A
LITTLE BIT DIFFERENTLY IN THE
FUTURE.
SO, NIH HAS AUTHORIZED THE USE
OF EXPEDITED REVIEW PROCESSES
TO IMPROVE THE EFFICIENCY AND
TIMELINESS OF MAKING CERTAIN
AWARDS.
THIS IS CALLED EXPEDITED
COUNCIL CONCURRENCE, AND IS
EXPECTED TO OCCUR ONCE EACH
COUNCIL ROUND, APPROXIMATELY
FOUR WEEKS BEFORE THE SCHEDULED
MEETING.
SO GENERALLY, WE USE ECC FOR
THE FOLLOWING TYPES OF
APPLICATIONS.
UNSOLICITED ELSI EXCEPT T32
WHICH ARE REQUIRED TO COME TO
COUNCIL.
SBIR.
CONFERENCE APPLICATIONS BECAUSE
THOSE ARE, YOU KNOW, HAVE A
TIME LIMIT AND NEED TO GET OUT
QUICKLY.
CAREER DEVELOPMENT APPLICATIONS.
SO K'S AND F'S.
UNSOLICITED RESEARCH
APPLICATIONS AND IN THE PAST WE
HAVE USED THIS FOR RO3 AND R21
WE ADDED UNSOLICITED RO1 AS
THINGS WE CAN BRING.
UNSOLICITED R 25.
AND ANY APPLICATION
ACCIDENTALLY OR THROUGH
ADMINISTRATIVE ERROR LEFT OFF
OF A PRIOR COUNCIL ROUND.
OCCASIONALLY THINGS SLIP
THROUGH THE CRACKS AND WE DON'T
WANT TO MAKE THE APPLICANTS
WAIT FOR A LONG TIME.
SO WE WILL BRING THOSE TO YOU.
SO THE SUBCOMMITTEE CONSISTS OF
3-4 COUNCILMEMBERS AND THANK
YOU TO THOSE OF YOU WHO ARE ON
OUR E.C.C. SUBCOMMITTEE WITH
BROAD EXPERTISE.
I THINK WE HAVE THAT HERE.
AND EACH SEPTEMBER WE WILL
REVIEW THAT AND GET NEW MEMBERS.
SO, HERE IS WHERE I WANT TO
BRING ATTENTION TO WHERE WE
MIGHT WANT TO USE THIS SOMEWHAT
DIFFERENTLY.
NORMALLY WE DO THIS PRIOR TO
COUNCIL.
HOWEVER, OTHER IC'S HAVE USED
IT ALSO TO DO IT AFTER OR AT
OTHER TIMES IN BETWEEN COUNCILS
WHEN IT BECAME NECESSARY.
AND AS YOU WILL KNOW WE HAD
SITUATIONS WHEN WE COULDN'T
HOLD COUNCILS WHEN WE EXPECTED
TO AND HAVE THE ABILITY TO USE
ECC IN THAT TIME WOULD HAVE
EXPEDITED SOME OF OUR
GRANTMAKING.
SO WHILE IT IS TYPICALLY ONE
MONTH PRIOR TO THE FEBRUARY,
MAY OR SEPTEMBER COUNCILS IT IS
NOT ALWAYS THAT TIME.
SO I JUST WANT TO BRING THAT TO
YOUR ATTENTION THAT WE MIGHT
INVOKE THIS AT OTHER TIMES
DURING THE YEAR, DEPENDING ON
NECESSITY.
WE NEVER HAVE IN THE PAST.
WE MAY IN THE FUTURE.
SO, YOU WILL GET FOR E.C.C.
CONCURRENCE, THE APPLICATION
NUMBER, P.I., INSTITUTION NAME,
PROJECT TITLE, IMPACT SCORE AND
PERCENTILE RANK.
IN MOST CASES YOU WILL ALSO
HAVE ACCESS TO THE SUMMARY
STATEMENT.
AND YOU ARE EXPECTED TO RESPOND
WITHIN SEVEN DAYS, IF THE
E.C.C. MEMBER DOES NOT RESPOND
WITHIN SEVEN DAYS IT'S
CONSIDERED AN EXTENSION.
AND WE WILL BASE THE VOTE ON
THE MAJORITY OF THE VOTES
RECEIVED.
ANY E.C.C. MEMBER CAN PULL AN
APPLICATION OFF THE LIST THAT
WE HAVE SENT YOU AND SAY, I
THINK THIS REALLY NEEDS TO GO
TO FULL COUNCIL AND HAVE A
DISCUSSION.
AND THAT IS FINE, YOU ALWAYS
HAVE THAT RIGHT TO RAISE A
PARTICULAR APPLICATION.
AND THEN THESE RECOMMENDATIONS
ARE ALL DOCUMENTED AND WILL BE
PRESENTED AT THE NEXT FULL
COUNCIL MEETING.
WE ALSO HAVE SOME
ADMINISTRATIVE AUTHORITIES
GENERALLY TO PROVIDE
SUPPLEMENTS AND OTHER MONETARY
ACTIONS THAT DO NOT NEED TO
COME TO COUNCIL.
SO DURING THE COURSE OF A
RESEARCH PROJECT A PRINCIPLE
INVESTIGATOR MAY REQUEST
ADDITIONAL FUNDS THROUGH AN
ADMINISTRATIVE RESUPPLEMENT AS
LONG AS THE WORK PROPOSED
DOESN'T EXPAND THE SCOPE OF THE
PROJECT BEYOND THAT WHICH WAS
PEER REVIEWED AND APPROVED BY
COUNCIL.
STAFF OF THE NHGRI WILL ANALYZE
AND REVIEW THE BUDGETS OF ALL
ADMINISTRATIVE SUPPLEMENT
APPLICATIONS BEFORE ISSUING ANY
AWARD.
SPECIAL NOTE IS MADE OF ANY
ITEMS REQUIRING ADJUSTMENT OF
AMOUNTS OR OTHER TERMS AND
CONDITIONS, THEY WILL NEGOTIATE
APPROPRIATE ADJUSTMENTS FOR
SUCH THINGS AS OVERLAPPING OR
DUPLICATE SUPPORT, INACCURATE
COST ESTIMATES OR ADJUSTMENTS
NECESSITATED BY THE RECOVERY OF
INDIRECT COSTS.
STAFF WILL ALSO MAKE
ADJUSTMENTS TO RECONCILE
INCONSISTENCIES BETWEEN
RECOMMENDED BUDGETS AND
RECOMMENDED ACTIVITIES.
SUPPLEMENTS FOR INITIATIVES TO
NHGRI AWARD WITHIN THE SCOPE OF
THE AWARD BUT FUNDED BY
INSTITUTES OR AGENCIES OTHER
THAN NHGRI DO NOT NEED COUNCIL
APPROVAL.
THE SUPPLEMENT WILL BE
DOCUMENTED AND REPORTED TO
COUNCIL FOR ITS INFORMATION AT
THE FIRST APPROPRIATE
OPPORTUNITY.
NHGRI MAY PROVIDE SUPPLEMENTS
TO GRANT AWARDS FUNDED BY OTHER
NHGRI INSTITUTES OR HHS
AGENCIES AS LONG AS WE ARE
ASSIGNED DUAL IC AND THE GRANT
HAS BEEN APPROVED BY THEIR
COUNCIL.
SO STAFF MAY MAKE SUPPLEMENTAL
AWARDS THAT ARE ABOVE THE LEVEL
RECOMMENDED BY THE COUNCIL AT
THE TIME OF THE INITIAL AWARD
AS LONG AS THAT GRANT HAS BEEN
APPROVED BY COUNCIL.
THESE SUPPLEMENTS ARE GENERALLY
TO TAKE ADVANTAGE OF UNEXPECTED
SCIENTIFIC OPPORTUNITIES THAT
HAVE THE POTENTIAL TO
ACCELERATE THE COMPLETION OF
SCIENTIFIC GOALS, OR TO PROVIDE
AN EXTENSION WITH FUNDS FROM
ONE YEAR.
IT SHALL NOT EXCEED THE CURRENT
LEVEL OF SUPPORT FOR THE
DURATION OF THE EXTENSION.
AN EXTENSION COULD BE MADE WITH
A COMPETING APPLICATION IS
REFERRED FOR RIO -- REVIEW,
WE DID A LOT OF THESE DURING
COVID.
EXCEPTIONAL SITUATION.
OR ANTICIPATION OF FUTURE
FUNDING WHEN CONTINUING FUNDING
APPLICATION WILL NOT BE PAID.
THOSE ARE THE SITUATIONS IN
WHICH WE DO THAT.
ALL SUPPLEMENT REQUESTS ARE
REVIEWED BY THE EXTRAMURAL
LEADERSHIP TEAM AND MUST BE
APPROVED BY THE E.L.T. BEFORE
AN AWARD MAY BE MADE AND
REGARDLESS OF THE AMOUNT WE
REPORT THESE TO YOU AT THE NEXT
POSSIBLE ADVISORY COUNCIL
MEETING.
THERE ARE OTHER SPECIAL
CATEGORIES OF SUPPLEMENTS STAFF
CAN MAKE, GENERALLY TO RESPOND
TO NIH-WIDE INITIATIVES.
THAT OCCUR.
SOME OF THOSE ARE CHANGING SO
I'M NOT READING THEM OUT ALL OF
THEM FOR YOU.
SO ALL OF THE ANY TIME THAT WE,
IN ANY OF THESE CIRCUMSTANCES
ARE SPECIAL FUNDING
OPPORTUNITIES WE PROVIDE
SUPPLEMENTAL FUNDING, WE WILL
BE DOCUMENTING AND PRESENTING
THESE TO YOU AT THE NEXT
COUNCIL MEETING.
NOW THERE ARE REQUESTS FOR
ADMINISTRATIVE INCREASES WHICH
EXCEED THE AMOUNTS OF THE
INITIAL AWARD.
AND IN THOSE CASES, WE WILL
COME TO COUNCIL FOR ADVICE AND
RECOMMENDATION BEFORE WE WOULD
FUND THEM.
BUT THOSE REQUESTS THAT DO NOT
EXCEED COUNCIL ADMINISTRATIVE
AMOUNTS ARE ONLY IF THEY MARK
EXPANSION OR SIGNIFICANT CHANGE
TO THE CONTENT OR IF STAFF
DETERMINES THEY INVOLVE ISSUES
ON WHICH COUNCIL SHOULD BE
CONSULTED.
SOMETIMES WE CAN DO THOSE
CONSULTATIONS BY EMAIL IF IT'S
AN ISSUE OF TIME SENSITIVITY.
SO THAT'S ANOTHER WAY IN WHICH
WE MAY OCCASIONALLY REACH OUT
TO YOU BETWEEN COUNCILS AND ASK
YOU TO WEIGH IN ON SOMETHING.
THERE ARE ALSO EXCEPTIONAL
SITUATIONS.
EXPEDITED COUNCIL REVIEW,
REQUESTS BETWEEN COUNCIL
MEETINGS MAY BE INITIATED UNDER
CERTAIN SITUATIONS MAY INCLUDE
TIME SENSITIVE REQUESTS,
APPLICATIONS RESPONDING TO
REQUEST FOR APPLICATIONS OR
LETTERS OF INVITATION, OR
UNSOLICITED GRANT APPLICATIONS
THAT ARE BELIEVED BY THE
DIRECTOR OF NHGRI, THE DIRECTOR
OF NIH OR DESIGNEE TO ADDRESS A
PUBLIC HEALTH EMERGENCY OR
REPRESENTING OPPORTUNITIES IN
BIOMEDICAL RESEARCH THAT WOULD
HAVE A SIGNIFICANT PUBLIC
HEALTH OR TRANSNIH IMPACT.
IN THE CASE OF A CRISIS OR
STATE OF EMERGENCY, INCLUDING
PANDEMIC, TERRORISM, ACTS OF
NATURE, ET CETERA OR TO REDUCE
TRAVEL BURDEN FOR
COUNCILMEMBERS AND THIS IS NOW
SORT OF RUN OF THE MILL BUT
USED TO BE SOMETHING WE NEEDED
AN AGREEMENT, COUNCIL MEETINGS
COULD BE CONDUCTED VIRTUALLY
USING SECURED VIRTUAL MEETING
PLATFORMS.
THREE OR MORE COUNCILMEMBERS
WITH THE APPROPRIATE EXPERTISE
AND REPUTATION WILL SECONDARY
REVIEW FOR ON BLOCK OR
INDIVIDUAL CONSIDERATION.
ALL RIGHT, SO WE WOULD LIKE
YOUR APPROVAL ON THE STATEMENT
OF UNDERSTANDING.
DOES ANYBODY HAVE ANY QUESTIONS
BEFORE WE GO TO A VOTE?
ALL RIGHT, MOTION TO APPROVE?
ALL RIGHT, AND SECONDS.
ALL IN FAVOR?
RAISE YOUR HAND.
LOOKS UNITED KINGDOM.
-- UNANIMOUS.
NOW PLEASE ENTER YOUR VOTES IN
ECB.
AND THAT IS YOUR LAST NEED TO
USE ECB THIS COUNCIL ROUND.
YOU WILL BE HAPPY TO HEAR.
AND THE FINAL ORDER OF BUSINESS
IS JUST TO GO OVER WHAT WE HOPE
TO BE OUR FUTURE MEETING DATES.
I NO LONGER PREDICT WHEN OUR
MEETING DATES ARE BECAUSE THEY
HAVE CHANGED A LOT.
AND THANK YOU ALL, BY THE WAY,
FOR YOUR FLEXIBILITY IN
ADAPTING AND THEN TO MY AMAZING
TEAM, COUNCIL COORDINATORS, AND
ALL THE HELPERS AND OUR I.T.
TEAM WHO HAVE ALSO ADAPTED TO
THE CONSTANTLY CHANGING NEEDS
OF COUNCIL THIS YEAR.
THE NEXT COUNCIL THAT WE HOPE
TO HAVE IN PERSON IS SEPTEMBER
15th-16th, 2025.
AFTER THAT, FEBRUARY 9-10, 2026.
MAY 18-19, 2026
SEPTEMBER 28-29, 2026 AND
FEBRUARY 8-9, 2027.
AND WE HAVE NOT SCHEDULED
BEYOND THAT.
IF YOU DO NOT HAVE THEM ON YOUR
CALENDARS, CONTACT COMFORT
BROWN AND SHE WILL MAKE SURE
THAT THEY ARE THERE.
DO YOU WANT TO CLOSE US OUT,
CAROLYN?
GO AHEAD, JUDY.
>> JUDY: FOR FEBRUARY 2026 FOR
THE OUT GOING GROUP WILL THAT
BE IN PERSON OR VIRTUAL, OR
IT'S NOT SETTLED YET?
>> JEN: I THINK WE WILL
CONTINUE TO HAVE OUR FEBRUARY
VIRTUAL BECAUSE OF
UNCERTAINTIES.
>> JUDY: OKAY, THANKS.
>> JEN: THANKS FOR ASKING.
OH, SORRY, I'M TURNING IT OVER
TO CAROLYN TO CONDUCT COUNCIL
INITIATED DISCUSSION, IS WHAT
I'M DOING.
>> CAROLYN: HI, EVERYBODY.
THIS IS JUST TIME FOR
COUNCILMEMBERS, IF THERE'S ANY
ITEMS THAT YOU WOULD LIKE TO
RAISE FOR US THAT WE DIDN'T
COVER IN TODAY'S AGENDA.
THIS COULD JUST BE INPUT TO
NHGRI, REQUESTS FOR TOPICS OR
THINGS YOU WOULD LIKE US TO
BRING TO FUTURE COUNCIL
MEETINGS OR QUESTIONS YOU HAVE
FOR LEADERSHIP OR STAFF.
DOESN'T SEEM TO BE ANYTHING,
WHICH IS COMPLETELY FINE.
I WILL GIVE YOU ONE MORE SECOND.
SO, NOW --
>> ACTUALLY, I WOULD SAY, ERICA
ALWAYS ASKS THIS, THERE'S NEW
LEADERSHIP, ARE THERE ANY
PEOPLE YOU WOULD BE INTERESTED,
TIM, GO AHEAD.
>> TIM: THANK YOU, I WANT TO GO
ON RECORD SAYING FUNDING IS
ABSOLUTELY CRITICAL AND ALL OF
THE TUMULT OVER THE PAST SIX
MONTHS TO A YEAR HAS BEEN
DEVASTATING TO NIH RESEARCH AND
I HOPE THAT THE NIH SEES A
CLEARER PATH IN THE FUTURE.
>> CAROLYN: THANK YOU.
JEN WAS PROMPTING A QUESTION
WHETHER THERE'S ANY MEMBERS
OUTSIDE OF NHGRI LEADERSHIP
THAT YOU WOULD LIKE US TO TRY
TO ARRANGE COME TO OUR COUNCIL.
I DID MENTION THAT DR.
BHATTACHARYA HAS SPOKEN AT A
COUPLE OF OTHER COUNCILS.
WE CAN REACH OUT, I DO THINK WE
WILL BE REACHING OUT TO HIM TO
GET ON TO THE AGENDA AND TRACK
FOR THAT.
I THINK WE DECIDED TO TRY TO
PREFERENCE THAT FOR A TIME WHEN
YOU ARE IN PERSON, RATHER THAN
VIRTUAL.
BUT IF THERE ARE OTHER PEOPLE
FROM NIH LEADERSHIP YOU WOULD
LIKE US TO TRY TO SCHEDULE OR
BRING TO FUTURE MEETINGS,
PLEASE LET US KNOW.
I THINK IN FEBRUARY WE HAD
JOANIE ON THE DOCKET.
SO WE MAY REVISIT ALSO WHO WE
HAD PREVIOUSLY HAD SCHEDULED
FOR THE COUNCILS THAT SORT OF
GOT CANCELLED.
YOU DID HAVE JOANIE?
I'M SORRY, I LEFT, SO.
>> YOU KNOW, GIVEN THE
QUESTIONS THAT PEOPLE HAVE HAD,
AND I DON'T KNOW WHAT THE RIGHT
TIMING IS FOR THIS, MAYBE WE
WAIT FOR MAY OR SEPTEMBER BUT
IT SEEMS LIKE LEADERSHIP FROM
CSR, FROM CENTER FOR SCIENTIFIC
REVIEW MIGHT BE HELPFUL AS THAT
IS MOVING FORWARD.
>> YEAH.
>> JUDY: I GUESS I HAVE A
QUESTION IF THE NLM, IF THAT
DIRECTOR, HAS ANYTHING MOVED ON
THAT?
>> CAROLYN: YEAH, SO I HAD SORT
OF ELUDED THAT THERE HAD BEEN
PEOPLE WHO WERE IN ACTING
POSITIONS PRIOR TO PREVIOUSLY
AND SO BOTH NLM AND MENTAL
HEALTH WERE IN ACTIVE JOB
SEARCHES AND THOSE GOT CAUGHT
UP IN THE HIRING FREEZE THAT
HAPPENED.
SO MY UNDERSTANDING IS IN
RESUMING THOSE THEY WON'T BE
STARTING FROM SCRATCH AND THEY
WILL BE COMING BACK TO SORT OF
PICKING THAT UP.
BUT THERE WAS A HIRING FREEZE.
SO STEVE SHERRY IS STILL IN THE
ACTING DIRECTOR POSITION FOR
NLM.
OKAY, THANK YOU ALL TO COUNCIL,
THANK YOU VERY MUCH TO ALL THE
NHGRI STAFF, BOTH IN FRONT OF
AND BEHIND THE SCENES WHO MADE
TODAY SUCH A SUCCESS.
THANK YOU TO MY LEADERSHIP TEAM.
THANK YOU TO BEN, ISSIL, NICK,
COMFORT AND JEN AND THANK YOU
TO ANYBODY WHO TUNED IN TO
WATCH, INCLUDING HOPEFULLY,
ROB'S PARENTS.
I HOPE EVERYBODY HAS A
WONDERFUL REST OF THE DAY.
ENJOY THE JUNETEENTH HOLIDAY
TOMORROW AND WE WILL REASSEMBLE
IN SEPTEMBER.
THANK YOU, ALL.
[ APPLAUSE ]