I WILL NOW CALL THE 117th
MEETING OF THE NATIONAL
ARTHRITIS AND MUSCULAR SKELETAL
ADVISORY COUNCIL TO ORDER.
AS YOU KNOW, ALL COUNCIL
MEETINGS ARE OPEN TO THE PUBLIC
AS REQUIRED BY LAW EXCEPT FOR
THE REVIEW, DISCUSSION AND
EVALUATION OF GRANT APPLICATIONS
AND RELATED INFORMATION.
I ALSO WANT TO REMIND YOU THAT
THIS MEETING IS BROADCAST BY NIH
VIDEOCAST AND IS BEING RECORDED.
SO, I WOULD LIKE TO WELCOME THE
STAFF AND GUESTS IN THE ROOM
WITH US ATTENDING THE MEETING IN
PERSON AS WELL AS THOSE
ATTENDING VIRTUALLY AND THOSE
WATCHING US THROUGH THE NIH
VIDEOCAST.
AND BEFORE WE GET STARTED I'D
LIKE TO GO AROUND THE TABLE FOR
INTRODUCTIONS.
AND THEN I'LL CALL ON THE
COUNSELORS VIRTUALLY TO
INTRODUCE THEMSELVES AS WELL.
LET'S START ON THE FAR RIGHT.
I THINK WE'RE STILL HAVING AUDIO
ISSUES BUT TO SPEAK PRESS YOUR
AUDIO BUTTON.
GO AHEAD AND WE'LL GO DOUBLE THE
ROW.
>> I'M SHARON AND RECENTLY THE
CEO OF THE ORTHOPEDIC RESEARCH
SOCIETY.
>> GOOD MORNING I'M A PROFESSOR
OF BIO MEDICAL ENGINEERING AT
THE WALLACE COULTER DEPARTMENT
AT GEORGIA TECH AND EMORY.
GOOD MORNING I'M SOCIAL DEAN OF
RESEARCH.
>> I'M THE FORMER EXECUTIVE
DIRECTOR OF THE AMERICAN SOCIETY
FOR BONE RESEARCH.
>> DOUGLAS KIEL SENIOR
SCIENTIST, MARCUS INSTITUTE FOR
AGING RESEARCH.
>>
>> I'M TAMARA ALLISTON.
>> I'M THE NIAMS DEPUTY
DIRECTOR.
>> FOR THOSE LISTENING AND
JOINING IN ON THE VIDEOCAST I'M
LINDSEY CRISWELL THE DIRECTOR OF
NIAMS.
>> I'M THE DIRECTOR OF
EXTRAMURAL ACTIVITIES AND
EXECUTIVE SECRETARY.
>> GOOD MORNING.
I'M MARY GARCIA THE INTERIM
DIRECTOR OF EXTRAMURAL RESEARCH
AT NIAMS.
>> I'M CHRISTEN MORGAN FROM THE
UNIVERSITY OF CONNECTICUT.
>> I'M MELISSA SPENCER A
PROFESSOR OF NEUROLOGY AT UCLA.
>> I'M WITH COLUMBIA UNIVERSITY.
>> GOOD MORNING.
I'M BECKY MILLER WITH THE
SOCIETY FOR INVESTIGATIVE
DERMATOLOGIES SO
>> I'M AT NORTHWESTERN IN
CHICAGO AND LEAD OUR CENTER FOR
GENETIC MEDICINE.
>> ABOUT MORNING I'M STEVE
KELLER PRESIDENT AND CEO OF THE
ARTHRITIS FOUNDATION.
>> WE'RE EXPECTING TWO OTHERS
AND I DO UNDERSTAND DR
DR. SUZANNASTEIN IS JOINING US.
DO YOU WANT TO SAY HELLO TO THE
FOLKS?
HER CAMERA WASN'T WORKING
EARLIER SO SHE MAY BE HAVING
TECHNICAL PROBLEMS BUT
APPRECIATE HER JOINING.
I THINK DR. BOB CARTER PREVIOUS
DEPUTY DIRECTOR MAY BE JOINING
LATER.
WE HAVE MANY STAFF FROM THE
INSTITUTE WITH US AND WON'T TAKE
THE TIME TO INTRODUCE ALL OF
THEM BUT AT SOME POINT DURING
THE MEETING ONE OR MORE OF THEM
MIGHT COME UP TO ADD COMMENTS AT
THAT POINT THEY'LL INTRODUCE
THEMSELVES SO YOU'LL KNOW WHO'S
SPEAKING.
ARRON, BACK OVER TO YOU.
>> THANK YOU.
VERY MUCH.
GOOD MORNING AND WELCOME.
I DO WANT TO POINT OUT WE HAVE
SOME COFFEE BACK HERE IN THE
CORNER IF YOU FEEL YOU NEED A
LITTLE BIT OF CAFFEINE AS THE
DAY GOES ON.
SO COUNCIL TODAY IS IN PERSON.
WE'RE MEETING COUNSELORS AND
STAFF JOINING REMOTELY OR IN
TEAMS.
WE'RE ALSO BROADCASTING A LIVE
NIH VIDEOCAST STREAM.
IF ANY STAFF MEMBER WATCHING ON
THE VIDEOCAST HAS AN URGENT
COMMENT OR QUESTION, PLEASE
E-MAIL SHANDA WELLINGTON AND CAN
DIRECT IT AS APPROPRIATE.
WE ENCOURAGE COMMENTS IN WRITING
UP TO 15 DAYS FOLLOWING THE
MEETING.
WE HAVE A SPECIAL MAILBOX TO
RECEIVE YOUR COMMENTS SENT TO
NIAMS COUNCIL MAIL ALL ONE WORD
AT MAIL DOT NIH DOT GOV.
ANYONE ON TEAMS MY SPEAK.
PLEASE MAKE SURE TO MUTE YOUR
LINE WHEN NOT SPEAKING.
WE DO ASK DURING PRESENTATIONS
YOU KEEP YOUR VIDEO OFF SO THE
PRESENTERS' VIEW IS HIGHLIGHTED.
YOU MAY ALSO RAISE YOUR HAND OR
WE CAN ALL ON YOU.
SHALANDA WILL HELP WITH MUTING
AND KEEP YOUR VIDEO ON EXCEPT
DURING PRESENTATIONS.
IF YOU NEED COMPUTER SUPPORT OR
HELP WITH THE ELECTRONIC COUNCIL
BOOK OR ECB DURING THE MEET
CONTACT SHALANDA.
SHE'S A KEY PERSON HERE FOR
EVERYTHING WE DO.
A NOTICE OF THIS COUNCIL MEETING
WAS PUBLISHED IN THE FEDERAL
REGISTER.
COUNCIL MEMBERS WERE ASKED TO
REMOVE THEMSELVES IF THEIR
PRESENCE MAY APPEAR AS A
CONFLICT OF INTEREST AND THE
REPORTING DATES WILL BE
REQUESTED IN JUNE, OCTOBER AND
FEBRUARY.
WHEN YOU RECEIVE THE REQUEST,
PLEASE RESPOND WITHIN 30 DAYS TO
RESPOND COUNCIL RELATED
ACTIVITIES.
FURTHER INFORMATION REGARDING
CONFLICT OF INTEREST REGULATION
INCLUDED ALSO IN THE ELECTRONIC
COUNCIL BOOK.
THE MEETINGS OF OUR APRIL 21
MEETING ARE POSTED ALSO IN THE
ELECTRONIC COUNCIL BOOK.
IF YOU WISH TO LOOK AT THOSE, I
WOULD ALSO LIKE TO NOW REMIND
YOU ABOUT THE DAYS OF FUTURE
COUNCIL MEETINGS IN THE ECB AND
ON OUR WEBSITE BUT OUR NEXT IN
PERSON MEETING OPEN SESSION WILL
BE OCTOBER 14, 2025 A HYBRID
MEETING.
GOING FORWARD WE PLAN TO HOLD
THE SPRING MEETING IN PERSON AND
THE FALL MEETING HYBRID AND THE
FALL MEETING VIRTUALLY, ACTUALLY
THE SPRING MEETING HYBRID TOO.
WE APPRECIATE YOUR PARTICIPATION
SO MAKE SURE THE DATES ARE ON
YOUR CALENDAR.
WE UPDATE THESE OCCASIONALLY ON
OUR WEBSITE AND WE'LL LET YOU
KNOW IF THERE ARE ANY CHANGES.
ARE THERE ANY QUESTIONS ABOUT
THIS?
S SEEING NO QUESTIONS I'LL PASS
IT BACK TO DR. CRISWELL.
>> I'LL START WITH MY REPORT AND
THANK YOU ARRON FOR COVERING THE
LOGISTICS.
SO I WANT TO START BY WELCOMING
BACK OUR AD HOC COUNCIL MEMBERS
DR. SARAH DEBAUR AND CHRISTEN
MORGAN AROUND AS IN PREVIOUS
MEETINGS WE INVITED OUTSTANDING
INVESTIGATORS FROM THE K01, K08
AND TO PARTICIPATE AS AD HOC
MEMBERS AND TO ALLOW US TO
OBTAIN INPUT FROM SCIENTISTS AT
THE AN EARLIER CAREER STAGE THAN
OUR FULL COUNCIL MEMBERS
TYPICALLY ARE.
DR. GOBAUER IS FROM THE SCHOOL
OF MEDICINE AND DR. MORGAN IS AT
THE UNIVERSITY OF CONNECTICUT
AND THEY JOINED US FOR OUR VERY
BRIEF COUNCIL MEETING IN APRIL
AND WILL BE PARTICIPATING AGAIN
TODAY.
SO PLEASE, BOTH OF YOU PROVIDE
YOUR VALUABLE PERSPECTIVES ON
ANY OR ALL TOPICS WE COVERED.
NOW, BEFORE MOVING ON TO TODAY'S
REPORT I'D LIKE TO TAKE A MOMENT
TO RECOGNIZE THE NIAMS
SCIENTIFIC REVIEW BRANCH.
AS I MENTIONED AT THE APRIL
MEETING, THE NIH ANNOUNCED PLANS
TO CENTRALIZED PEER REVIEW OF
APPLICATIONS WITHIN THE NIH
CENTER FOR SCIENTIFIC REVIEW
ALSO CALLED CSR.
SO WITH MIXED EMOTIONS, I'D LIKE
TO SHARE THIS WILL BE THE LAST
COUNCIL MEETING THE
SCIENTIFIC REVIEW OFFICERS OR
SROs, SCIENTIFIC REVIEW BRANCH.
DR. FANG AND ARGENITA AND MANY
WHO HAVE WORKED WITH AS WELL AS
OTHERS WHO WILL BE JOINING THE
CSR.
NOW, THE GOOD NEWS IS THOUGH THE
TWO NIAMS STANDING STUDY
SECTIONS AMS AND AMC WILL BE
DISCONTINUED.
MOST SROs WILL CONTINUE WORKING
ON APPLICATIONS WITHIN THE
MISSION AREAS IN NEW POSITIONS.
SO WE'D LIKE TO THANK THEM FOR
THEIR OUTSTANDING CONTRIBUTIONS,
THEY'RE UNWAVERING COMMITMENT
AND UTMOST PROFESSIONALISM AND
TIRELESS DEDICATION IN SERVICE
TO NIAMS.
NOW, DURING THIS TRANSITION
DR. SALIDA CHIEF OF THE NIAMS
SCIENTIFIC REVIEW BRANCH WILL
REMAIN AT THE INSTITUTE TO
MANAGE OUR RECEIPT AND REFERRAL
AND ASSIST WITH ACTIVITIES IN
THE DIVISION OF EXTRAMURAL
RESEARCH.
THANK YOU SO MUCH, KATHY.
SO MY REPORT TODAY WILL FOCUS ON
THE NIH AND NIAMS BUDGET AND
ACTIVITIES THAT MAY BE OF
GENERAL INTEREST.
NOW, TODAY'S DIRECTOR'S REPORT
IS A BIT SHORTER THAN USUAL
BECAUSE COUNCIL MET A BIT OVER
THE MONTH AGO WHEN WE HAD THE
RESCHEDULED MEETING THAT WAS
SUPPOSED TO HAPPEN AT THE
BEGINNING OF THE YEAR.
THEY'RE OPERATING UNDER THE FULL
YEAR CONTINUING APPROPRIATIONS
AND EXTENSIONS 2025 ALSO KNOWN
AS HR1968 WHICH THE PRESIDENT
SIGNED MARCH 25, 2025.
NOW, FOR NIAMS, THIS MEANS OUR
CURRENT FISCAL YEAR 2025 ENACTED
BUDGET EQUALS THE COMPARABLE
BUDGET NUMBER FROM FISCAL YEAR
2024.
AND CONSISTENT WITH OUR PREVIOUS
PRACTICE IN RECENT YEARS WE
DECIDED THE BEGINNING OF THE
FISCAL YEAR TO SET OUR PAY LINE
AT THE EIGHT PERCENTILE MORE
GENEROUS FOR EARLY STAGE
INVESTIGATORS BECAUSE IT GIVES
MORE FLEXIBILITY.
WE'LL CONTINUE TO SCRUTINIZE THE
MERITORIOUS APPLICATIONS IN
THEIR PORTFOLIOS TO IDENTIFY
HIGH PRIORITY PROJECTS FOR THE
INSTITUTE TO FUND.
NOW, MOVING TO THE NEXT FISCAL
YEAR'S BUDGET, IN MAY, PRESIDENT
TRUMP WILL RELEASE THE OVERVIEW
OF HIS DISCRETIONARY FUNDING
REQUEST FOR FISCAL YEAR 2026
THAT WOULD START OCTOBER 1.
THE BUDGET REQUEST FOR NIH IS
APPROXIMATELY $27 BILLION
REPRESENTING AN $18 BILLION
REDUCTION FROM THE FISCAL YEAR
2025 ENACTED LEVELS.
LAST FRIDAY THE DEPARTMENT OF
HEALTH AND HUMAN SERVICES
PRESENTED THE HHS FISCAL YEAR
2026 BUDGET IN BRIEF WHICH
PROVIDES MORE DETAILS ABOUT THE
AGENCY'S BUDGETARY PLAN FOR ITS
COMPONENTS INCLUDING NIH.
THE BUDGET PROPOSAL FOR NIH IS
SHOWN ON THIS SLIDE AND IT
PROVIDES $27.5 BILLION IN
DISCRETIONARY BUDGET AUTHORITY
FOR NIH.
NOW, IT ALSO PROPOSES TO
RESTRUCTURE NIH BY CONSOLIDATING
PROGRAMS INTO FIVE FOCUS AREAS.
THE NATIONAL INSTITUTE ON BODY
SYSTEMS RESEARCH, THE NATIONAL
INSTITUTE ON NEURAL SCIENCE AND
BRAIN INSTITUTE, THE GENERAL
MEDICAL SCIENCES, NATIONAL
INSTITUTE FOR CHILD AND
WOMEN'S'S DISORDERS AND
COMMUNICATION AND THE NATIONAL
INSTITUTE ON BEHAVIORAL
RESEARCH.
THE BUDGET WILL RETAIN THE NCI,
NIAD AND ELIMINATING MINORITY
HEALTH, THE FOGARTY CENTER AND
NATIONAL INSTITUTE FOR
INTEGRATIVE AND COMPLEMENTARY
HEALTH AND THE ENVIRONMENTAL
HEALTH SCIENCES INSTITUTE WOULD
BECOME PART OF THE NEW
ADMINISTRATION FOR A HEALTHY
AMERICA.
IMPORTANTLY THOUGH OVER THE NEXT
FEW MONTHS, THE HOUSE AND SENATE
WILL DEVELOP THEIR OWN BUDGET
PROPOSALS FOR FISCAL YEAR 2026
WHICH WILL THEN NEED TO BE
RECONCILED AND A FINAL BILL
GOING BACK TO THE PRESIDENT FOR
SIGNATURE.
NEXT I WANT TO HIGHLIGHT TWO
EVENTS THE NIAMS DEPUTY DIRECTOR
ENGAGED IN WITH CONGRESSIONAL
MEMBERS AND THE NIAMS
COMMUNITIES.
YOU CAN SEE DR. PAYNE AND OTHERS
ON EITHER SIDE OF ANNA ON THE
LEFT AT ONE OF THESE ACTIVITIES.
SO FIRST, THERE WAS A
CONGRESSIONAL BRIEFING THE PHOTO
ON THE LEFT.
REPRESENTATIVE JOHN JOYCE A
DERMATOLOGIST FEATURED INSPIRING
SKIN DISEASE PATIENTS,
RESEARCHERS AND HEALTH CARE
PROVIDERS TO BRING AWARENESS OF
SKIN DISEASES TO MEMBERS OF
CONGRESS, THEIR STAFFERS AND
FEDERAL AGENCY EMPLOYEES.
LATER IN MAY, DR. MAZUKA JOINED
MANY NIH LEADERS AND SEVERAL
CONGRESS MEMBERS AT THE 2025
ACCEPTABILITY GALA ORG --
ORGANIZED BY DOWNS SYNDROME.
NIH PARTICIPATES IN THE INCLUDE
PROJECT FOR INVESTIGATION OF
CO-OCCURRING CONDITIONS ACROSS
THE LIFE SPAN TO UNDERSTAND
DOWNS SYNDROME.
DR. MAZUKO HAS BEEN INVOLVED IN
THE PLANNING, COORDINATION AND
EXECUTING OF THIS INITIATIVE IN
HER PREVIOUS ROLES WITHIN THE
NIH OFFICE OF THE DIRECTOR.
AND AS PART OF THE INCLUDE
PROJECT, NIAMS RESEARCHERS ARE
EVALUATING THE SAFETY AND
EFFICACY OF A JAK INHIBITOR AND
DEVELOPED WITH HELP MUCH OUR
INTRAMURAL RESEARCH PROGRAM IN
ADOLESCENTS WITH DOWNS SYNDROME
OR AUTOIMMUNE SKIN CONDITION.
THANK YOU, ANNA FOR REPRESENTING
NIAMS AT THAT EVENT AND WE
APPRECIATE OPPORTUNITIES LIKE
THESE TO EDUCATE CONGRESSIONAL
MEMBERS TO ENGAGE WITH THE
COMMUNITIES.
NOW, MOVING CLOSER TO HOME, ON
THE SAME DAY WE MET IN APRIL,
NIH DIRECTOR BHATTACHARYA
INTRODUCED THEMSELVES AT THE
COUNCIL OF COUNCIL MEETING AND
INTRODUCE HIS VISION FOR THE
NIH.
AS YOU MAY KNOW, THE COUNCIL OF
COUNCILS ADVISES THE NIH
DIRECTOR AND THE DIVISION OF
PROGRAM COORDINATION, PLANNING
AND STRATEGIC INITIATIVES OR
DPCPSI.
THE COUNCIL ALSO PROVIDES
FEEDBACK ON NEW POTENTIAL NIH
WIDE INITIATIVES.
SO I HOPE YOU HAD A CHANCE TO
LISTEN TO HIS TALK BUT IF NOT'S
AVAILABLE THROUGH THE NIH
VIDEOCAST ARCHIVE.
NEXT I'D LIKE TO HIGHLIGHT THE
NEW TRANS NIH ACTIVITY THAT MAY
BE OF INTEREST TO YOU
SPECIFICALLY THE NIH RECENTLY
ANNOUNCED IT IS ADOPTING AN
INITIATIVE TO EXPAND INNOVATIVE
HUMAN-BASED SCIENCE WHILE
REDUCING ANIMAL USE IN RESEARCH.
SO WHILE TRADITIONAL ANIMAL
MODELS CONTINUE TO BE VITAL TO
ADVANCING SCIENTIFIC KNOWLEDGE,
USING NEW EMERGING TECHNOLOGIES
CAN OFFER UNIQUE STRENGTHS WHEN
UTILIZED CORRECTLY OR IN
COMBINATION CAN EXPAND THE
TOOLBOX FOR RESEARCHERS TO
ANSWER PREVIOUSLY DIFFICULT OR
UNANSWERABLE BIOMEDICAL RESEARCH
ANSWERS INCLUDING ORGANOIDS AND
TISSUE CHIPS AND OTHER IN VITRO
SYSTEMS TO CAPTURE HUMAN
VARIABILITY AND EVEN PATIENT
SPECIFIC CHARACTERISTICS,
COMPUTATIONAL MODELS THAT
SIMULATE COMPLEX BIOLOGICAL
HUMAN SYSTEMS, DISEASE PATHWAYS
AND DRUG INTERACTIONS AND REAL
WORLD DATA THAT ALLOWS
SCIENTISTS TO STUDY HEALTH
OUTCOMES IN HUMANS AT COMMUNITY
AND POPULATION LEVELS.
SO TO INTEGRATE INNOVATIVE
HUMAN-BASED SCIENCE, NIH INTENDS
TO ESTABLISH THE OFFICE OF
RESEARCH INNOVATION VALIDATION
AND APPLICATION OR ARIVA WITHIN
THE NIHs OFFICE OF THE DIRECTOR.
THIS NEW OFFICE WILL COORDINATE
NIH EFFORTS TO VFSHLGS VALIDATE
AND SCALE THE USE OF KNOWN
APPROACHES ACROSS THE BIOMEDICAL
PORTFOLIO AND SERVE AS THE HUB
FOR INTERAGENCY COORDINATION AND
REGULATORY TRANSLATION FOR
PUBLIC HEALTH PROTECTION.
IT WILL ALSO EXPAND FUNDING AND
TRAINING IN NON-ANIMAL
APPROACHES AND AWARENESS OF
THEIR VALUE IN TRANSLATIONAL
SUCCESS.
SO WE LOOK FORWARD TO WORKING
CLOSELY WITH ORIVA ON THE
INITIATIVE.
SO, WHEN COUNCIL MET IN JANUARY
OF LAST YEAR I INTRODUCED YOU TO
THE COMMON FUND SYSTEMS BIOLOGY
DATA PLATFORM WHICH LEVERAGES
THE ACCELERATED MEDICINES
PARTNERSHIP OR AMP VENTURE
INITIATIVE PROGRAM.
AS YOU MAY KNOW, NIAMS IS AN
ACTIVE PARTNER OF THE AMP
PROGRAM.
WE HELPED LEAD THE AMP RA LUPUS
AND HELPING LEAD THE AUTOIMMUNE
AND IMMUNE MEDIATED DISEASE OR
AIMS PROGRAMS.
THESE PROJECTS HAVE GENERATED
IMPRESSIVE MULTI-OMIC DATA TO
INTERROGATE SHARED MECHANISMS OF
DISEASE.
NOU, THE AMPS PRESENTED A RICH
OPPORTUNITY THEY ALSO COME WITH
CHALLENGES COMMON ACROSS THE BIO
MEDICAL ENTERPRISE BUILT ON
DIFFERENT PLATFORMS AND USE
DIFFERENT DISEASE SPECIFIC DATA
STANDARD.
THEREFORE ALL THE INSTITUTES AND
CENTERS PARTICIPATED IN THE AMPS
HAVE COME TOGETHER TO ADDRESS
THIS COMMON ISSUE.
TO DO SO WE PARTNERED WITH THE
NIH COMMON FUND VENTURE PROGRAM
TO LAUNCH SYS BIO AS WHAT IS
NEEDED TO HARMONIZE DATA AND
PROVIDE THE SINGLE ACCESS POINTS
FOR RESEARCHERS TO QUERY THE
FULL DATA SETS HARMONIZED
TOGETHER AND THE PLATFORM WILL
PROVIDE TOOLS TO LOOK AT GENES,
MOLECULES, CELLS AND PATHWAYS.
WE ALSO RECOGNIZE THIS OPEN DATA
ACCESS SUPPORTS EARLY STAGE
INVESTIGATORS AND ENABLES A
ROBUST SCIENTIFIC DISCOURSE.
LAUNCHED LAST FALL AS THE FIRST
SYS BIO AWARD OUR INVESTIGATOR
TEAM IS BUILDING THE FAIRPLEX
THAT IS A FAIR PLATFORM FOR
EXPLORATION OF SYSTEMS BIOLOGY
DATA.
THE PLATFORM AIMS TO USE FAIR
PRINCIPLES THAT IS FINDABLE,
ACCESSIBLE, INTEROPERABILITY AND
REUSABLE TO MAXIMIZE THE VALUE
OF THE AMP DATA ECO SYSTEM AND
THE INVESTMENTS.
SO FAIRPLEX WILL PROVIDE A
SINGLE POINT OF ENTRY FOR
RESEARCHERS TO ACCESS DIVERSE,
HARMONIZED DATA AND USER
FRIENDLY EXPLORATORY TOOLS.
NOW, SWITCHING TO THE NIAMS
INTRAMURAL PROGRAM I PREVIOUSLY
SHARED WITH YOU ABOUT THE NIAMS
INTRAMURAL RESEARCHERS RECEIVING
AWARDS IT FOR EXCITING WORK THAT
FIRMS UNDER THE STRATEGIC
PRIORITY TO STUDY MOLECULAR AND
CELLULAR MECHANISMS OF HEALTH
AND DISEASE IN HUMANS AND THE
RESULTING PHENOTYPED AND
ENDOTYPES.
I'LL DELIGHTED TO ANNOUNCE IN
THE OFFICE OF AUTOIMMUNE
RESEARCH INTRAMURAL AWARDS THREE
OTHER RESEARCHERS WERE AWARDED
FUNDING.
DR. KAPLAN WILL STUDY THE IMPACT
OF GUT INFLAMMATION AND
LOW-GRADE MYOCARDITIS AND LUPUS
AND PRESENTS WITH PRESENTING
WITH OVERLAPPING OR CO-OCCURRING
SYSTEMIC AUTOIMMUNE DISEASES.
DR. GRAYSON WILL PARTNER WITH
WILL LOOK AT AUTOIMMUNITY AND
DR. LEWANDOWSKI AND WE ALSO
RECEIVED SUPPORT FOR
COLLABORATION WITH OUR NIEHS
COLLEAGUES TO LAUNCH THE
LONGITUDINAL EXPOSURE DATA FROM
THE STUDY TO STUDY SISTERS OF
WOMEN WITH BREAST CANCER WHO
SUBSEQUENTLY DEVELOP LUPUS.
ONCE AGAIN MY CONGRATULATIONS TO
DR. KAPLAN, GRAYSON AND
LEWANDOWSKI AND LOOK FORWARD TO
SHARING RESULTS FROM THESE
EXCITING STUDIES.
IN OUR LAST MEETING UP APRIL I
MENTIONED THE POLICY TO
ACCELERATE BROAD ACCESS TO
RESEARCH RESULTS.
THE MOST SIGNIFICANT CHANGE IS
THE REMOVAL OF THE EMBARGO
PERIOD AND THE MANUSCRIPT MUST
BE MADE PUBLICALLY AVAILABLE.
IN ADDITION TO THE UPDATED
POLICY, NIH ISSUED SUPPLEMENTAL
GUIDANCE ON PUBLICATION COSTS
AND ON GOVERNMENT USE LICENSE
AND RIGHTS.
IMPORTANTLY, NIH ANNOUNCED LAST
MONTH THE REVISED POLICY WILL GO
INTO EFFECT FOR PEER-REVIEWED
MANUSCRIPTS ACCEPTED ON OR AFTER
JULY 1 OF THIS YEAR RATHER THAN
DECEMBER 31 AS ORIGINALLY
PLANNED.
UNTIL THAT TIME, NIHs CURRENT
PUBLIC ACCESS POLICY FROM 2008
WILL REMAIN IN EFFECT.
BROADLY THE NEW NIH POLICY AIMS
TO MAXIMIZE AND ACCELERATE
ACCESS TO SCIENTIFIC DATA AND
SCHOLARLY ARTICLES RESULTING
FROM FEDERAL FUNDING AND TO MAKE
RESEARCH RESULTS EASIER TO FIND
AND MORE TRANSPARENT BY USING
METADATA AND PERSISTENT
IDENTIFIERS.
NEXT, NIH RECENTLY ANNOUNCED AN
UPDATED POLICY ON FOREIGN SUB
AWARDS.
EFFECTIVE MAY 1, NIH WILL NOT
ISSUE AWARDS TO DOMESTIC OR
FOREIGN ENTITIES WHETHER NEW,
RENEWAL OR NON-CONTINUATION AND
NIH WILL NO LONGER ACCEPT PRIOR
APPROVAL REQUESTS TO ADD A NEW
COMPONENT OR SUBAWARD TO AN
ONGOING PROJECT.
IN ALL CASES, NIH WILL ALLOW
INSTITUTES TO RENEGOTIATE THE
AWARDS WHETHER NEW, RENEWAL OR
NON-COMPETING TO REMOVE THE SUB
AWARDS TO FOREIGN ENTITIES AND
WHERE WORK CAN BE PERFORMED
DOMESTICALLY REBUDGETED TO USE
FOR THE PRIME RECIPIENT WHETHER
DOMESTIC OR FOREIGN OR A
DOMESTIC SUB RECIPIENT.
IF A PROJECT IS NO LONGER VIABLE
WITHOUT THE FOREIGN SUBAWARD,
NIH WILL WORK WITH THE RECIPIENT
TO NEGOTIATE A BILATERAL
TERMINATION OF THE PROJECT
TAKING INTO CONSIDERATION ANY
NEED TO SUPPORT PATIENT SAFETY
OR ANIMAL WELFARE.
NIH'S POLICY CHANGE APPLIES
PROSPECTIVELY TO ALL NIH GRANTS
AND COOPERATIVE AGREEMENTS TO
DOMESTIC AND FOREIGN ENTITIES
AND NOT RETROACTIVELY REVISE
ONGOING AWARDS TO REMOVE THE
FOREIGN SUB AWARDS AT THIS TIME.
AND THE POINT I WANTED TO
HIGHLIGHT IS THE NEXT ONE WHICH
IS THAT NIH CONTINUES TO SUPPORT
DIRECT FOREIGN AWARDS.
SO THE ISSUE IS SUBAWARDS, NOT
DIRECT FOREIGN AWARDS.
THIS POLICY APPLIES TO ALL
MONETARY FOREIGN COLLABORATIONS.
IT DOES NOT APPLY TO FUNDS
PROVIDED TO SUPPORT FOREIGN
CONSULTANCES OR PURCHASING
UNIQUE EQUIPMENT OR SUPPLIES
FROM FOREIGN VENDORS.
ANOTHER POLICY UPDATE I HOPE YOU
WILL SHARE WIDELY AMONG YOUR
COLLEAGUES IS A SHORT-TERM
EXTENSION TO THE ESI ELIGIBILITY
PERIOD.
IN ADDRESSING DELAYS IN
SUBMISSIONS OR PEER REVIEW OR
AWARD PROCESSING TIME LINES
BETWEEN JANUARY 1 AND MAY 31 OF
THIS YEAR AND SEEKING TO
MITIGATE THEIR AFFECT ON THE
COMMUNITY THERE'S AN AUTOMATIC
EXTENSION OF ESI ELIGIBILITY FOR
INVESTIGATORS WHOSE LAST
SUBMISSION DATE FOR A NEW OR
REVISED APPLICATION BASED ON ESI
ELIGIBILITY IS OCTOBER NOVEMBER
24 OR FEBRUARY, MARCH, 2025 OR
JUNE, JULY, 2025.
THE NEW LAST SUBMISSION AS AN
ESI FOR THESE INVESTIGATORS WILL
BE OCTOBER 2025.
FINALLY, NIH IS REQUESTING
STRATEGIES FOR MITIGATING
CONTROLLED ACCESS HUMAN GENOMIC
DATA LEAKAGE WHEN DEVELOPING AND
SHARING GENERATIVE TOOLS AND
APPLICATIONS.
IMPORTANTLY, THESE STRATEGIES
SHOULD STILL PROMOTE AND ENABLE
WIDESPREAD INNOVATION AND
ADOPTION OF RESPONSIBLE A.I. FOR
BIOMEDICAL RESEARCH BUT THE NIH
IS COMMITTED TO IMPROVE THE
HEALTH OF THE PUBLIC AND AS YOU
KNOW, TO UPHOLD THE PRINCIPLES
ESPOUSES IN THE NIH GENOMIC
SHARING POLICY, NIH HAS
TEMPORARILY PAUSED THE SHARING
OF GENERATIVE A.I. MODELS AND
THEIR PARAMETERS BASED ON NIH
HUMAN CONTROLLED ACCESS DATA AS
WELL AS THE RETENTION OF THESE
TOOLS BEYOND THE PROJECT'S CLOSE
OUT.
PUBLIC RESPONSE TO THIS RFI WILL
HELP INFORM FUTURE GUIDANCE
ABOUT THIS VERY IMPORTANT ISSUE.
THE DEADLINE FOR SUBMITTING AN
ONLINE RESPONSE IS JULY 16 OF
THIS YEAR.
I ENCOURAGE ALL OF YOU TO SHARE
THIS WIDELY.
SO I'D LIKE TO END MY REPORT
THIS MORNING WITH A REMINDER
ABOUT THE NIH GRANTS AND FUNDING
WEBSITE AND ENCOURAGE ALL OF YOU
TO CHECK THE PAGE OFF FOR THE
LATEST POLICY UPDATES AND
FUNDING ANNOUNCEMENTS.
SO, ON THAT NOTE, THANK YOU VERY
MUCH FOR YOUR ATTENTION AND I
WANT TO OPEN THE FLOOR NOW TO
HEAR FROM YOU ABOUT ANY
QUESTIONS YOU'D LIKE TO RAISE OR
QUESTIONS I CAN TRY TO ADDRESS.
BEFORE WE MOVE I THINK
DR. CARTER HAVE JOINED.
LET'S LET THEM SAY HELLO AND
INTRODUCE THEMSELVES BRIEFLY.
>> I CAN START.
I AM A PROFESSOR AND DIVISION
CHIEF AT THE UNIVERSITY OF
CALIFORNIA SAN FRANCISCO AND SAN
FRANCISCO DENTAL HOSPITAL AND I
STUDY THE EPIDEMIOLOGY AND
OUTCOMES OF RHEUMATIC DISEASE.
NICE TO BE WITH YOU ALL.
>> THANK YOU.
>> GOOD MORNING.
>> HI, JOB.
>> BOB CARTER FORMERLY DEPUTY
DIRECTOR SUPPORTING LINDSEY AND
NOW CONSULTANT SUPPORTING ANNA
AND LINDSEY AND WORKING ON THE
ROLE AS CO-COORDINATOR IN THE
SYSCO PROJECT AND I APPRECIATE
YOU JOINING BECAUSE IN THESE
TOUGH TIMES YOUR SUPPORT IS
REALLY VALUABLE AND THOUGHTS
VERY WELCOME.
THANK YOU.
>> THANKS, BOB.
I COULDN'T AGREE MORE ON THAT
AND THANK YOU AND SUZANNA BOTH
AND YOUR EXPERIENCE AND WISDOM
ARE SO INCREDIBLY VALUABLE NOW
SO APPRECIATE YOUR ONGOING
SUPPORT.
I'LL DO A TIME CHECK.
WE PLANNED THIS SESSION WOULD GO
TO 10:20 SO WE HAVE PLENTY OF
TIME NOW TO RAISE QUESTIONS,
ISSUES AND WE'LL HAVE MORE TIME
AS WELL AS LATER IN THE MEETING.
SO IF WE DON'T GET TO YOUR
QUESTION DURING THE SUBMISSION
SEGMENT, NO FEAR WE'LL GET TO
THAT LATER.
>> THANK YOU FOR THE UPDATE.
REAL QUICK QUESTION.
I'M NOT FAMILIAR WITH THE PLAN
IN DETAIL DOES IT ALSO INCLUDE
CHANGES TO THE CSR FOR REVIEW?
>> SO LET ME EMPHASIZED THE
PROPOSED REORGANIZATION IS NOT A
DONE DEAL YET.
IT'S JUST A PROPOSAL AND WE
STILL HAVE A LOT OF THINGS THAT
HAVE TO HAPPEN AND DISCUSSIONS
BEFORE WE UNDERSTAND TO WHAT
EXTENT, IF ANY, THERE'LL BE
REORGANIZATION ALONG THOSE
LINES.
IN TERMS OF THE RESTRUCTURING OF
CSR, A FEW MONTHS BACK, A
DECISION WAS MADE TO CENTRALIZE
REVIEW ACTIVITIES.
AND SO THAT HAS BEEN A REALLY
CHALLENGING PROCESS LED BY THE
DIRECTOR OF CSR WITH THE
COOPERATION AND COLLABORATION OF
ALL THE INSTITUTES AND CENTERS
AND SO NOW REVIEW STAFF I THINK
BY END OF JUNE WILL BE
CONSOLIDATED WITHIN CSR AND THE
STUDY SECTIONS THAT HAD BEEN RUN
AND STAFF OUT OF THE INSTITUTES
NO LONGER EXIST.
SO A VERY BIG CHANGE.
WE'LL BEING FOLLOWING CLOSELY TO
MAKE SURE THAT ALL OF THE
BREADTH AND DEPTH OF THE
SCIENTIFIC AREAS CONTINUE TO
HAVE OUTSTANDING PEER REVIEW.
ALSO, I WANT TO REMIND YOU ALL
THAT WHILE THE PEER REVIEW
PROCESS IS INCREDIBLY IMPORTANT
AND THE SCORES REFLECT VERY
IMPORTANT ASSESSMENTS OF
ASPECTS, ULTIMATELY THE
INSTITUTES DECIDE WHICH
APPLICATIONS THEY'RE GOING TO
FUND.
SO WE HAVE NOT LOST ANY OF THAT
DISCRETIONARY POWER AND
AUTHORITY.
DURING THIS TRANSITION PERIOD
THAT'S AS IMPORTANT AS EVER.
I WANT TO MAKE SURE YOU
UNDERSTAND THAT IMPORTANT PIECE.
DR. KIEL, PLEASE, YES.
>> I WANTED TO RAISE A QUESTION
ABOUT THE NEW PROCESS FOR
SUBMITTING CONCEPT PROPOSALS,
NOFO'S AND THE LIKE I UNDERSTAND
IT GOES THROUGH MULTIPLE LAYERS
OF REVIEW WHICH CONDITION RESULT
IN DELAYS IN POSTING.
THOSE WHO RECEIVE THE WEEKLY
BULLETIN OF NOTICES HAVE NOTICED
THERE ARE NO NOTICES HARDLY AND
I WAS TOLD THAT'S BECAUSE
THEY'RE MAKING THEIR WAY THROUGH
THE NEW REVIEW PROCESS.
CAN YOU COMMENT ON ANY EXISTING
OR PLANNED PROPOSAL ANNOUNCEMENT
THAT ARE DELAYED OR MAYBE IN THE
NEW REVIEW PROCESS?
>> THAT'S A BIG COMPLICATED
TARGET AND SO MANY THINGS ARE
THESE DAYS.
LET ME MAKE A FEW COMMENTS AND
I'LL CALL ON OTHERS FOR
ADDITIONAL POINTS.
ONE IS THAT GOING BACK I THINK
AT LEAST SEVERAL YEARS, THE
DEPARTMENT OF HEALTH AND HUMAN
SERVICES HAVE HAD A STRONG
DESIRE TO SIMPLIFY NOFOs.
FOR THOSE WHO READ THEM I'M SURE
IT WILL RESONATE WITH YOU.
ONE WAS ON THE BOOKS UNTIL VERY
RECENTLY 31 OR 41 PAGES LONG AND
WHEN I TAKE A LOOK AT THESE I
CRINGE.
SO THERE'S BEEN A LONG STANDING
EFFORT BY HHS TO TRY TO SIMPLIFY
NOFOs.
WITH THIS CURRENT ADMINISTRATION
AT THE NIH VARIOUS
CONSIDERATIONS, EFFICIENCY AND
COORDINATION, ETCETERA HAVE
PROMPTED THE NIH TO TAKE THIS
ANOTHER STEP FURTHER AND TO
FULLY EMBRACE THE SIMPLIFIED
NOFO CONCEPT AND TO DRASTICALLY
DECREASE THE NUMBER OF NOFO.
AND THOSE INVOLVED IN APPLYING
FOR GRANTS YOU KNOW THIS BETTER
THAN I RECALL, BUT FOR EXAMPLE
EVEN FOR A SINGLE CONCEPT THERE
MAY BE DIFFERENT NOFOs FOR THE
FUNDING MECHANISM.
A LOT OF WORK HAS BEEN UNDERWAY
WITHIN THE OFFICE OF EXTRAMURAL
RESEARCH AND RELATED OFFICES,
DR. BORSCH HAS STEPPED UP AND IS
HELPING US WITH THIS PROCESS TO
TRY TO FIGURE OUT HOW BEST TO
CONSOLIDATE -- SIMPLIFY,
CONSOLIDATE AND EVEN CENTRALIZE
SOME OF THE NOTICES OF SPECIALTY
INTEREST.
SO INVESTIGATORS DON'T HAVE TO
LOOK AT EVERY SINGLE INSTITUTE
AND CENTER TO SEE WHAT ARE THEIR
AREAS OF HAVE BUT CAN GO TO ONE
SPOT AND SEE A LIST OF ALL THE
NOTICES MUCH SPECIAL INTEREST.
IT'S BEEN VERY CHALLENGING
TRYING TO FIGURE OUT HOW TO
STREAMLINE, ETCETERA.
NOW, ON A SEPARATE ISSUE RAISED
HAS TO DO WITH REVIEW OF THESE.
SO MY UNDERSTANDING OF THE PLAN
AND THIS IS UNDERWAY.
IT'S POSSIBLE THAT SOME CHANGES
MAY BE MADE BASED ON HOW THIS IS
GOING BUT A VERY VERY HIGH LEVEL
SUMMARY OF A CONCEPT IS SENT TO
HHS AS A FORECAST FOR THEIR
REVIEW AND APPROVAL.
THEN IT COMES BACK TO THE NIH
AND IS EVALUATED CENTRALLY AND
THEN GETS PRESENTED TO COUNCILS
FOR APPROVAL AND THEN THERE MAY
OR MAY NOT BE ACTION TAKEN ON
THE CONCEPTS.
BUT SO IN OTHER WORDS AFTER A
CONCEPT PRESENTED THERE MAY BE
SPECIFIC RFAs THAT FOLLOW BUT
GIVES US THE OPPORTUNITY TO
CONSIDER AND THAT AND HAVE A
COUPLE CONCEPTS TODAY.
AND AT THE OUTSET THERE'LL BE
DELAYS BECAUSE WE'RE TRYING TO
ACCOMPLISH A LOT OF DIFFERENT
THINGS.
IT'S NOT CLEAR TO ME DOWN THE
ROAD WE'RE GOING TO BE LOOKING
AT SIGNIFICANTLY LONGER DELAYS.
I THINK IT'S TOO SOON TO TELL
AND LET ME PAUSE THERE AND SEE
WHETHER DARREN OR OTHERS WANT TO
ADD TO MY COMMENTS OR I MAY NOT
HAVE EXPRESSED SOMETHING EXACTLY
CORRECTLY.
>> I THINK YOU EXPLAINED IT VERY
WELL.
THERE WERE SOME DELAYS BUT YOU
CAN SEE WE'RE HAVING THREE
CONCEPT CLEARANCES TODAY WE GOT
APPROVAL FOR.
JUSTINE BUSHMAN AND SHALANDA
HAVE BEEN WORKING HARD TO GET
THE SYSTEM TO WORK AND SO FAR
EVERYTHING HAS BEEN APPROVED.
WE HAVEN'T HAD ANY NOs FOR
ANYTHING.
GOING FORWARD NOW I DON'T THINK
THERE'LL BE SIGNIFICANT DELAYS.
WE JUST HAVE TO MAKE OUR PLANS A
BIT FURTHER AHEAD OF TIME.
GIVEN IN MIND YOU NEED EXTRA
APPROVAL.
I DON'T THINK IT WILL BE A BIG
DEAL AND SO FAR IT'S BEEN
WORKING FOR US.
>> ANOTHER COMPLICATING FACTOR
AND WE PRESENTED AND YOU MAY
RECALL THERE ARE NEW REVIEW
CRITERIA NOW SIMPLIFIED REVIEW
CRITERIA.
SO THAT WAS ANOTHER LITTLE
HICCUP THAT CAUSED SOME NOFOs TO
BECOME INACTIVE AND HAVE BEEN
TRYING TO GET NOFOs WITH
SIMPLIFIED REVIEW CRITERIA AND
THE LAST POINT DARREN MENTIONED,
NIAMS AT ANY GIVEN TIME HAS HAD
RELATIVELY FEW NOFOs.
I DON'T THINK WE'LL BE EXPECTED
TO REDUCE THE NUMBER AT ALL.
OTHER INSTITUTES HAD MANY MANY
NOFOs.
THAT'S A BIG CHALLENGE FOR THEM.
THE OTHER AREAS WHERE THERE'S
CHALLENGES WITH PROGRAMS LIKE
HEAL AND NOFOs SO WE'RE SPARED A
LOT OF THE ANGST FOR THOSE
REASONS.
THANKS FOR ASKING ABOUT THAT.
>> ARE THERE QUESTIONS FOR
AWARDS --
>> I EXPECT GUIDANCE WILL BE
FORTHCOMING BUT THE MOST
IMPORTANT THING TO KEEP IN MIND
IS NO ONE IS SAYING YOU CAN'T
USE ANIMAL MODELS BUT THE USE
HAS TO BE VERY WELL JUSTIFIED.
WHAT ALL THE OPTIONS ARE, WHAT
YOU'RE TRYING TO ACCOMPLISH, HOW
THIS ANIMAL MODEL OR THESE
ANIMAL MODELS WOULD UNIQUELY
ADVANCE THE RESEARCH.
YOU HAVE TO JUSTIFY THE USE OF
ANIMALS AND SHOW HOW IT'S TAKING
YOU -- HELPING YOU MOVE TOWARDS
HUMAN DISEASE.
DO ANY OF MY COLLEAGUES KNOW IF
THERE'S PLANS FOR SPECIFIC
GUIDANCE THROUGH THE ORIVA
EFFORT?
>> THEY'RE WORKING ON THAT
PRESUMABLY THEY'LL BE PUTTING
OUT GUIDANCE ON THOSE.
>> WE CAN TAKE A NOTE TO
FOLLOW-UP WITH NICOLE KLE
KLEINSTREURER.
I'M TRYING TO LOOK AROUND FOR
HANDS.
ANY OTHER QUESTIONS YOU WANT TO
RAISE AT THIS POINT ABOUT
ANYTHING I SHARED, SOMETHING YOU
WANT TO RAISE AT THIS POINT?
IF NOT, WE'LL HAVE OTHER
OPPORTUNITIES.
IT SEEMS THERE'S BEEN PUBLIC
STATEMENTS MADE BY THE NIH
DIRECTOR AND OTHERS AND OST
ABOUT GOLD STANDARD RESEARCH AND
WHETHER WE CAN ANTICIPATE
CHANGES COMING.
I KNOW THERE'S BEEN A FOCUS ON
RIGOR AND REPRODUCIBILITY FOR
MORE THAN THE LAST DECADE AND
DON'T KNOW IF WE CAN EXPECT
REVISIONS OR EXPECTATIONS AROUND
THAT.
>> THERE'S BEEN A LOT OF
CONFUSION AROUND THAT TOO.
SO I GUESS YOU SAID WHAT I WOULD
SAY WHICH IS THE MAIN THING, THE
WAY I INTERPRET THAT IS THAT NOW
MORE THAN EVER THERE'S GOING TO
BE A FOCUS ON REPRODUCIBILITY,
REPLICATION STUDIES, ROBUST
METHODS.
IT'S NOT CLEAR TO ME THAT
ANYTHING ELSE IS GOING TO BE
DRAMATICALLY DIFFERENT.
BUT I DON'T KNOW WHETHER ANYBODY
ELSE HAS HEARD DISCUSSION ON
WHAT THAT MIGHT MEAN FOR US
BEYOND REPRODUCIBILITY AND
REPLICATION STUDIES.
>> I THINK A LOT OF US WERE
TAKEN ABACK GIVEN THE PUSH FOR
SOME OF US DOING SCIENCE FOR A
LONG TIME.
I THINK RIGOR AND
REPRODUCIBILITY HAVE GOTTEN
SUBSTANTIALLY BETTER SO I WAS
SURPRISED TO HEAR THAT.
>> THE OTHER THING I'LL ADD IS A
BIG FOCUS FOR THE ADMINISTRATION
HAS BEEN ON CONCERN ABOUT
DISTRUST IN SCIENCE AND THE
SCIENTIFIC PROCESS AND
ACADEMICS.
SO I THINK THIS ALSO MAY BE AN
ATTEMPT AT A HIGH LEVEL TO TRY
TO INCREASE TRUST IN SCIENCE.
SO MAYBE MORE.
>> I WELCOME THE OPPORTUNITY TO
STATE IF ONE LOOKS AT THE DATA
FROM THE STUDY WHICH DOCUMENTS
REDUCTION IN TRUST, VERY SMALL,
I MIGHT ADD AMONG MEDICAL
SCIENTISTS AND SCIENTISTS, THE
LEVEL OF REDUCTION IN TRUST IS
IN FACT ALMOST EVERY OTHER
PROFESSION.
THERE'S ONLY ONE PROFESSION THAT
DIDN'T SHOW A DECLINE IN TRUST
AND THAT'S RELIGIOUS LEADERS.
EVERYONE ELSE SHOWED DRAMATIC
DECLINES FROM 2016 OR 2019 TO
WHEN THE DATA CAME OUT.
THIS DISTRUST IN SCIENCE JUST
SIMPLY PARALLELS AND IS ACTUALLY
BETTER FOR SCIENTISTS THAN IT
HAS BEEN FOR ANY OTHER
PROFESSION AND POINT OUT THE
GROUP WITH THE LOWEST LEVEL OF
TRUST AND SAW A SIGNIFICANT
DECLINE WAS ELECTED OFFICIALS.
IT'S VERY EASILY ACCESSIBLE.
LOOK UP THE DATA ON THE PUGH
FOUNDATION AND WE SHOULD BE
CAUTIOUS IN THE REDUCTION OF
TRUST IN SCIENCE AND BIO MEDICAL
SCIENTISTS.
IT REALLY ISN'T TRUE IN THAT
THERE'S DISTRUST IN MANY OTHER
THINGS AND THERE'S MANY REASONS
BUT ALTERNATIVE INFORMATION IN
RESEARCH.
>> THANK YOU.
THE BROADER CONTEXT IS
INCREDIBLY IMPORTANT AND THANK
YOU FOR THE REMINDER AND FOR
DIRECTING US TO THAT SURVEY.
THANK YOU.
>> THIS IS A BIT OUT OF STROKE
BUT IT'S MY UNDERSTANDING THE
PROCESS OF SCIENTIFIC REVIEW IS
ALSO CHANGING SUBSTANTIALLY IN
HOW THE STUDY SECTIONS ARE
PERFORMING REVIEWS AND HOW THE
SUMMARY STATEMENTS WILL BE.
>> I THINK YOU'RE REFERRING TO
WHAT HAVE BEEN CALLED THE
SIMPLIFIED REVIEW CRITERIA THAT
WERE LARGELY THE MAIN GOAL WAS
TO DECREASE REPUTATIONAL BIAS
AND FOCUS ON THE NEEDS OF THE
PROJECT INSTEAD OF SAY THE
REPUTATION OF THE INSTITUTION,
ETCETERA.
SO, THE SIMPLIFIED REVIEW
CRITERIA WENT INTO EFFECT I
THINK IN JANUARY.
IMPORTANTLY, THEY HAVE NO IMPACT
ON THE APPLICATIONS OR HOW
INVESTIGATORS SHOULD PREPARE
THEIR APPLICATIONS.
IT IS COMPLETELY ON THE SIDE OF
HOW REVIEWERS WILL REVIEW THEM.
I DON'T HAVE A SLIDE ON THAT
HERE BUT YEAH, I THINK THAT'S
WHAT YOU MUST BE THINKING ABOUT.
>> INDEED.
I WAS A LITTLE CURIOUS WITH THE
PAY LINE SET WHERE THEY ARE TO
HAVE SOME LEVEL OF FLEXIBILITY
OF FUNDING WITHIN THE PRIORITIES
OF NIAMS, THE EXTENT TO WHICH
THE CHANGE IN THE FORMAT MAY
COMPLICATE YOUR ABILITY TO
ASSESS THOSE THINGS.
THE FEEDBACK YOU MIGHT GET FROM
THE SCIENTIFIC REVIEW COMMITTEES
COULD BE.
>> I DON'T THINK SO BUT I GUESS
I'LL ALSO SHARE THAT WE HAVE
STFSHG REVIEW OFFICERS THAT ARE
INVOLVED IN OBSERVING THE STUDY
SECTIONS SO WE HAVE
OPPORTUNITIES TO TRACK THIS.
I'M NOT ANTICIPATING THAT THAT
IS GOING TO BE A COMPLICATING
FACTOR FOR US.
I THINK MUCH MORE SIGNIFICANT IS
CONSOLIDATING THE REVIEWS
CENTRALLY BUT ONCE AGAIN WE --
OUR PROGRAM OFFICERS ARE
FAMILIAR WITH THE APPLICATION
AND SCIENTIFIC REVIEW OFFICERS
ARE INVOLVED IN THE MEET AND WE
HAVE A STRATEGIC PLAN AND WE DO
PORTFOLIO ANALYSIS SO WE HAVE
LOTS OF TOOLS THAT ALLOW US TO
TRY TO CONSIDER OTHER FACTORS
BEYOND THE SCORE.
I LIKE TO REMIND FOLKS WHENEVER
THE SUBJECT COMES UP THAT
DR. BYRNES THE DIRECTOR OF CSR
THAT FUNDING DECISIONS ARE NOT
MADE EXCLUSIVELY ON THE BASIS OF
THE SCORES.
WHERE THERE'S GAPS AND AND AVOID
REDUNDANCIES IN THE THINGS WE'RE
FUNDING.
THE SCORE ONE PIECE BUT NOT
EVERYTHING.
I SEE A COUPLE OTHER -- THANKS
FOR RAISING THAT.
>> FIRST, I JUST WANT TO THANK
YOU AND ALL THE NIAMS STAFF FOR
YOUR LEADERSHIP DURING THIS TIME
AND WE'RE VERY GRATEFUL.
MY QUESTION IS DO YOU EXPECT THE
NIAMS FUNDING PRIORITIES WILL
CHANGE AT ALL OVER THE LAST
YEAR?
I CONTINUE TO GET A LOT OF
QUESTIONS ESPECIALLY FROM
TRAINEES ABOUT THINGS LIKE
HEALTH DISPARITIES RESEARCH SO
ANY UPDATED GUIDANCE ON THAT
WOULD BE VERY APPRECIATED?
>> THANK YOU, FIRST OF ALL,
THANK YOU FOR YOUR SUPPORT.
I HAD THE OPPORTUNITY TO ATTEND
TWO MEETINGS RECENTLY THE FID
MEETING AND SO RATIFYING TO
FIELD THE REPORT FROM THE
COMMUNITY AND SO SOBERING TO
HEAR MORE DIRECTLY THE
CHALLENGES YOU'RE ALL FACING.
I APPRECIATE THE OPPORTUNITY TO
ENGAGE WITH INVESTIGATORS AND
COUNCIL MEMBERS.
I THINK YOU'RE ALL PROBABLY VERY
WELL AWARE OF A COUPLE VERY
SPECIFIC ISSUES, DEI, CLIMATE
CHANGE, ETCETERA THAT HAVE BEEN
IDENTIFIED AS NON-PRIORITIES FOR
THIS ADMINISTRATION WITH ALL THE
CONSEQUENCES OF THAT.
ON THE NOTE OF HEALTH
DISPARITIES THOUGH A LOT OF
EFFORT HAS BEEN DEVOTED TO
TRYING TO CLARIFY THAT HEALTH
DISPARITIES IS DIFFERENT FROM
DEI AND HEALTH DISPARITIES IS A
PERFECTLY LEGITIMATE IMPORTANT
TOPIC THAT WE NEED TO CONTINUE
TO WORK ON.
SO I KNOW IT'S A COMMON SOURCE
OF CONCERN AND CONFUSION.
IN TERMS OF THINKING MORE
BROADLY INCLUDING ABOUT THIS
ADMINISTRATION PRIORITIES WE
FEEL NIAMS IS VERY WELL
POSITIONS.
THERE'S AN AWFUL LOT OF CHRONIC
DISEASE, COMMON AND RARE,
AUTOIMMUNE DISEASE AND DISEASES
THAT AFFECT WOMEN
DISPROPORTIONATELY.
SO WE FEEL WELL POSITIONED IN
TERMS OF OUR PRIORITIES AND AS
ARTICULATED IN THE PLAN WITHIN
THE EXCEPTION OF A FEW SPECIFIC
AREAS AND OUR INVESTMENTS IN
THOSE AREAS ARE NOT NEARLY AS
SIGNIFICANT AS MANY OTHER
INSTITUTES.
SO WE HAVE HAD FEWER CHALLENGES
TO DEAL WITH IN TERMS OF SAD LY
GRANT DETERMINATIONS.
AND ANOTHER THING I'LL POINT OUT
IS THAT SOME OF OUR VERY
IMPORTANT EFFORTS SUCH AS THE
AMP PROGRAM AND SYSTEMS BIOLOGY
AND SYS BIO AND INTEROPERABILITY
ARE WELL ALIGNED ON WHAT WE'RE
HEARING ON A WEEKLY BASIS FROM
NIH LEADERSHIP.
I THINK WE'RE IN A GOOD POSITION
RELATIVELY SPEAKING FOR SURE.
YES.
>> ALONG THOSE LINES I WAS
NOTICING HEALTH AND DISEASE IN
DIVERSE POPULATION IS IN THE
TRIFOLD ARE YOU EXPECTING THINGS
OF RFAs IN THAT AREA OF
RESEARCH?
>>
>> YOU MEAN SETTING ASIDE FUNDS
FOR SPECIFIC AREAS HAS BEEN
CHALLENGING FOR US TO DO WITH
SUCH A TIGHT PAY LINE BUT WE
PLAN TO CONTINUE TO REFER TO OUR
STRATEGIC PLAN IN TERMS OF AREAS
WHERE INVESTMENT IS NEEDED AND
MONITOR AND TRACK THE PROGRESS
WE'RE MAKING IN THOSE AREAS AND
WE ALSO PLAN TO CONTINUE TO
ISSUE NOSIs OR NOTICES OF
SPECIAL INTEREST WHATEVER
THEY'RE CALLED IN THE FUTURE.
SO RFAs MAY BE TRICKY FOR US
BECAUSE IT REQUIRES A SET ASIDE
CURRENTLY WE RECEIVED
PROPORTIONATELY MANY MORE
APPLICATIONS RELATIVE TO THE
BUDGET WE RECEIVED FROM CONGRESS
COMPARED TO MOST OTHER
INSTITUTES.
SO A CHALLENGE TO SET ASIDE
FUNDS.
THAT'S WHY WE'VE WORKED SO HARD
TO TRY TO LEVERAGE COMMON FUND,
VENTURE SPACE, WHAT ARE SOME
OTHER THINGS?
WE'VE BEEN VERY SUCCESSFUL IN
LEVERAGING OTHER FUNDING SOURCE
TO MAKE UP FOR THAT.
YOU ALL MET BRIEFLY THIS MORNING
DR. ALLISTON WHO WILL PROVIDE
INFORMATION ON THE NIH INTERIM
PROGRAM.
SHE IS NOW THE SCIENTIFIC
DIRECTOR OF THE INTERIM RESEARCH
PROGRAM AND IN ADDITION TO
PLANNING, COORDINATING AND
DIRECTING THE IRP BASIC AND
SCIENTIFIC RESEARCH PROGRAMS,
HER KEY RESPONSIBILITIES INCLUDE
RECRUITING AND RETAINING WORLD
CLASS INVESTIGATORS AND CHARTING
THE FUTURE DIRECTION OF IRB
RESEARCH.
I'VE BEEN THRILLED TO HEAR FROM
TAMARA HER VISION EVEN IN THE
SHORT TIME HERE
DR. ALLISTON WILL
UPDATE YOU.
>> IT'S GREAT TO SHARE THIS
UPDATE ON BEHALF OF THE
INTRAMURAL RESEARCH PROGRAM.
BY OVERVIEW I'LL FIRST PROVIDE
AN INSTRUCTION.
I BELIEVE I NEED ASSISTANCE WITH
THE SLIDES.
I THINK THERE'S A DISCONNECT
WITH WHAT'S ON THE SCREEN AND
WHAT'S ON TEAMS.
FIRST BACKGROUND ABOUT MYSELF
BEFORE GIVING AN OVERVIEW OF THE
I RP THE INTRAMURAL RESEARCH
PROGRAM AND UPDATES ON AWARDS
AND PROMOTIONS AS WELL AS A
GLIMPSE INTO WHERE WE'RE HEADED
NEXT.
SO, ABOUT ME, I EARNED A Ph.D.
IN CELL BIOLOGY AND TRAINED AS A
BIOLOGIST THROUGH TEXAS AND THEN
BY WAY OF SAN FRANCISCO WHERE I
COMPLETED A POSTDOC STUDYING
BETA SIGNALLING AND WHERE MY
LOVE OF BONE BIOLOGY CAME INTO
THE FOREFRONT.
I WAS UNFORTUNATE TO BE ABLE TO
DEVELOP MY OWN LAB AT UCSF AND
HAVE BEEN AS A FACULTY MEMBER
UNTIL JANUARY.
I HAVE A FOCUS ON TGF BETA
SIGNALLING AND HOW IT'S
IMPORTANT IN HOMEOSTASIS AND
DISEASE.
OUR WORK LED US TO FOCUS ON
OSTEOCYTES AND THEIR ROLE IN
CONTROLLING BONE QUALITY AS WELL
AS OSTEOARTHRITIS AND OTHER
SYSTEMIC DISEASES.
ASIDE FROM MY CREDENTIALS AS A
SCIENTIST, I THINK THE THINGS
THAT TRACT ATTRACTED ME TO WORK
AT NIAMS WERE THE PROGRAMATIC
ACTIVITIES.
THE OPPORTUNITY TO MENTOR
TALENTED STUDENTS AND POSTDOCS,
PEOPLE FROM A BASIC SCIENCE,
ENGINEERING OR CLINICAL
PERSPECTIVE AS WELL AS
LEADERSHIP ROLES IN DIFFERENT
GRADUATE PROGRAMS AT UCSF
INCLUDING BEING A P.I. OF
MULTIPLE T32s AT DIFFERENT
POINTS.
IN ADDITION, I HAD SEVERAL
DIFFERENT ROLES IN PROGRAMATIC
LEADERSHIP BOTH WITHIN THE
MUSCULOSKELETAL SPACE AND
DEVELOPING A NEW MUSCULOSKELETAL
SYSTEM AND SERVE AS THE P.I. AS
THE NIAMS P30 AS A GREAT
OPPORTUNITY TO PROVIDE CORE
STRUCTURE AND SERVICE TO THAT
BROAD COMMUNITY FROM BIOLOGISTS
TO EPIDEMIOLOGISTS.
I HAD AN OPPORTUNITY TO SERVE IN
OTHER ROLES AND HAVE BEEN
PIVOTAL IN MY PROFESSIONAL
DEVELOPMENT AND JUST JOINED IN
2025.
AT A SCIENTIFIC LEVEL, THESE ARE
SOME BEAUTIFUL IMAGES THAT MY
LAB HAS DEVELOPED OVER THE YEARS
AND I LIKE TO SHARE THEM JUST AS
A POINT OF ADMIRING AND
APPRECIATING THE VISUAL ARTISTRY
AND VISUAL SCIENCE THAT WE DO
AND ON THE TOP LEFT IS A PICTURE
OF A HUMAN FEMORAL HEAD
COLLECTED FROM ONE OF THE
ORTHOPEDIC SURGEONS I HAD THE
FORTUNATE TO COLLABORATE WITH
LOOKING AT THE STRAIN THROUGH A
MICRO-CT SCAN THEN ON THE TOP
RIGHT IS AN IMAGE FROM THE
ADVANCED LIGHT SOURCE OF
LAURENCE BERKELEY NATIONAL LABS
LOOKING AT MINERAL DENSITY IN
BONES AT A HIGH RESOLUTION AND
THE BONE IS NETWORKS AND
DENDRITES AND THE LOWER RIGHT IS
LOOKING AT SOME TGF BETA
RECEPTORS TRAPPED AROUND FOCAL
ADHESION.
WE HAVE DIFFERENT LINK SCALES
FROM HUMAN AND CELL AND
MOLECULAR BIOLOGY TO NOW MORE
SYSTEMS APPROACHES AND THROUGH
THE LENS OF UNDERSTANDING THE
INTERACTION OF PHYSICAL SIGNALS
IN THESE UNIQUELY MECHANICAL
TISSUES THAT PLAY A ROLE IN
SIGNALLING ROLES FROM THE
PERSPECTIVE OF MECHANO BIOLOGY
AND HOW DO PHYSICAL FEATURES
DIRECT THE BIOLOGICAL FUNCTIONS
AROUND FROM A BIO MECHANICS
PERSPECTIVE AND HOW IS IT
BIOLOGICAL FACTORS DEFINE THE
UNIQUE PROPERTIES OF THE TISSUES
AND HOW DO THEY DECLINE WITH
AGING OR DISEASE.
TGF BETA HAS BEEN A POWERFUL
LENS THROUGH WHICH WE'VE TAKEN
ON THE CHALLENGES AND I THINK
THIS APPROACH GOING FROM CELL
AND ANIMAL MODELS TO HUMAN
CONDITIONS AND GENETICS THINKING
ACROSS THE ENGINEERING AND LIFE
SCIENCE BASE IS SOMETHING THAT
EQUIPS ME TO SERVE IN THIS ROLE
AT THE INTRAMURAL RESEARCH
PROGRAM AND EXCITE ABOUT
BUILDING MY OWN LABORATORY HERE
AS PART OF THAT PROGRAM.
SO, IT IS TRULY A PRIVILEGE TO
STEP INTO LEADERSHIP AT THIS
TIME AND PLACE.
I THINK ANYONE KNOWS YOU FEEL
FORTUNATE AS A LEADER TO FOLLOW
ON SOMEONE'S LEADERSHIP AND I'VE
FOLLOWED DR. O'SHAY'S DIRECTION
AS DIRECTOR OF THE PROGRAM.
HE SERVED IN THAT ROLE FOR 20
YEARS AND REMAINS AN INTEGRAL
PART OF OUR SCIENTIFIC PROGRAM
AND IS READY TO HAND OVER THE
REINS OF THIS LEADERSHIP
COMPONENT.
HE HAS BUILT A WONDERFUL STRONG
IRP AND IS IT EXCITING TO STEP
INTO THIS ROLE.
SO FOR THOSE WHO ARE LESS
FAMILIAR WITH THE INTRAMURAL
RESEARCH PROGRAM AS I WOULD
ADMIT I WAS AND HAVE BEEN
LEARNING A LOT THE IRP
REPRESENTS 11.5% OF THE BUDGET
AND THE BUDGET IS AROUND $79
MILLION.
THIS IS CONSISTENT ACROSS ALL OF
THE INSTITUTES AT NIH, THE
INTRAMURAL RESEARCH PROGRAM FOR
NIAMS IS ON TARGET WITH WHAT IT
IS FOR ALL THE OTHERS.
OF THAT BUDGET, ABOUT HALF OF IT
IS DEDICATED TOWARDS -- I WON'T
SAY INTERDIRECT COSTS BUT
THINGS -- INDIRECT COST BUT
THINGS SET AND FIXED IN TERMS OF
RESOURCES NEEDED TO OPERATE THE
REMARKABLE NIH CLINICAL CENTER
AND IT'S THE REMAINING PIECE WE
USE TO DEFINE AND RUN THE
SCIENTIFIC PROGRAM THAT I LEAD,
THE CLINICAL PROGRAM WHICH IS
LED BY MY COLLEAGUE, DR. RO
DR. ROBERTFULBERT AND THE
TRAINING AND ADMINISTRATION.
TO GIVE PERSPECTIVE, THE
SCIENTIFIC PROGRAM IS DIVERSE
AND EXPANDS FROM BASIC
TRANSLATIONAL AND POPULATION
RESEARCH AND THERE'S ABOUT 25
MORE SENIOR LEVEL INVESTIGATORS
WHO ARE DRIVING THOSE RESEARCH
AGENDAS AND IT'S ALSO SUPPORTED
BY SOME OUTSTANDING RESEARCH
WHICH I'LL TELL YOU A LITTLE BIT
MORE ABOUT.
THE OTHER IS THE CLINICAL
PROGRAM WHICH OPERATES THROUGH
THE NIH CLINICAL CENTER.
THERE'S TWO BUSY CONSULT
SERVICES ON RHEUMATOLOGY AND
DERMATOLOGY AND WE'RE TAKING
CARE OF AND LEARNING ABOUT
PEOPLE WITH RHEUMATOLOGIC AND
DERM TOLL OGIC DISEASE AND AND
PROVIDING SUPPORT IN NCI OR
NIDDK AND ALL THE OTHER
INSTITUTES WHEN THOSE PATIENTS
HAVE THOSE CONCERNS.
SO THIS IS A REALLY IMPORTANT
PART OF WHAT THE NIAMS
INTRAMURAL PROGRAM DOES THAT
DERMATOLOGY GROUP IS THE BUSIEST
OF ALL THE CLINICAL CONSULT
SERVICES IN ADDITION WE ALSO RUN
A FELLOWSHIP PROGRAM IN
DERMATOLOGY.
IN ADDITION TO THE SCIENTIFIC
AND CLINICAL PROGRAM LIKE
EXTRAMURAL INSTITUTIONS WE HAVE
A VIBRANT AND CRITICAL TRAINING
PROGRAM WITH ABOUT 90 TRAINEES
AND SUPPORTED BY AN
ADMINISTRATIVE BRANCH AND THIS
COMPRISES ABOUT 263 STAFF.
MANY OF WHOM ARE SENIOR
SCIENTISTS WORKING IN THE LABS
OF THESE DIFFERENT INVESTIGATORS
AND THE CLINICAL PROGRAMS.
SO, IT'S NICE AT THIS
APPOINTMENT OF COUNCIL TO TAKE A
SMALL STEP BACK FROM THE FIRST
FOUR MONTHS OF LEARNING SO MUCH
AND SOME UNIQUE CIRCUMSTANCES.
TO REFLECT ON ABOUT WHAT STANDS
OUT AND MAKES THE PROGRAM UNIQUE
AND SPECIAL AND STRONG.
AS AN EXTRAMURAL PERSON WE ALL
UNDERSTAND THE UNIQUE FUNDING
MECHANISM THAT WE HAVE HERE AND
HOW THE ACCESS TO INTRAMURAL
FUNDING PROVIDES THE OPPORTUNITY
FOR HIGH RISK, HIGH IMPACT
SCIENCE AND SO I THINK THESE ARE
POINTS THAT ARE ABOVE AND BEYOND
WHAT WE ALREADY KNOW THAT HAVE
REALLY STRUCK ME.
SO I THINK THE INTRAMURAL
PROGRAM PROVIDES AN INCREDIBLE
OPPORTUNITY AND I'VE SEEN IT ON
A DAILY BASIS FOR TRANSLATIONAL
DISCOVERY.
WHAT I MEAN BY THAT?
IT'S SIGN THAT IS HUMAN CENTERED
AND STARTS WITH OBSERVATIONS IN
THE CLINIC AND MOTIVATE AND
DRIVE THE KINDS OF DISCOVERY
SCIENCE IN THE LAB THAT ENABLES
THOSE QUESTIONS TO BE ADDRESSED.
SO THE SCIENCE IS DEEPLY BASIC,
VERY FUNDAMENTAL BUT VERY CLOSE
TO THE PATIENT.
SOME OF THE THINGS THAT ENABLE
THAT TO HAPPEN ARE THE STRENGTHS
OF THE NIH CLINICAL CENTER AND
STUDYING AND UNDERSTANDING RARE
DISEASES BOTH IT THOSE WITHIN
THE NIAMS MISSION AREA AND
BEYOND WHERE THERE ARE
MUSCULOSKELETAL SKIN OR
RHEUMATOLOGICAL COMPONENTS AN
ROBUST LONGITUDINAL COHORTS
STUDIES IN SOME CASES FOR
DECADES THAT ENABLE DEEP
DISCOVERY.
WE HAVE POWERFUL INTEGRATED
SCIENTIFIC CORPS LED BY
SCIENTISTS AND DEEPLY INVOLVED
IN THE RESEARCH OF EVERY PROGRAM
WITHIN THE INTRAMURAL RESEARCH
PROGRAM AND I THINK THAT PROPELS
CERTAIN PRECISION MEDICINE
APPROACH THAT HAS THINGS COMING
FROM THE LAB DIRECTLY TO
PATIENTS AND SUPPORTED BY
TECHNOLOGY TRANSFER OFFICE THAT
FACILITATES THIS AND I WAS PROUD
TO DISCOVER NIAMS INVESTIGATORS
ARE AMONG THE BEST AT NIH IN
MOVING OUR DISCOVERIES INTO THE
CLINIC AND COMMERCIAL SPACE.
ANOTHER MAJOR UNIQUE THING IS
THE SCIENTIFIC WORKFORCE.
INTERESTINGLY TODAY I HAD TO GO
BACK AND DOUBLE CHECK I HAD THE
DEGREES CORRECT ON EACH OF OUR
INVESTIGATORS BECAUSE IT'S
SOMETIMES DIFFICULT TO KNOW IF
SOMEBODY WAS Ph.D. TRAINED OR
M.D. TRAINED BECAUSE THEY'RE
BLURRING OR GRAZING THE LINES
EVERY TIME AND I CAN SAY FOR
ALMOST EVERY INVESTIGATOR IN THE
IRP.
ANOTHER FEATURE IS LONG-TERM
STAFF SCIENTISTS WITH STABILITY
AND DIFFICULT TO SUSTAIN IN AN
EXTRAMURAL ENVIRONMENT BY NATURE
OF THE FUNDING MECHANISM AND
TRAINING MISSION OF THE
UNIVERSITY.
BECAUSE WE HAVE THIS STAFF
SCIENTIST EXPERTISE IT ENABLED
US TO PROVIDE AN OUTSTANDING
TRAINING ENVIRONMENT FOR
POST-BACS RIGHT OUT OF UNDERGRAD
AS WELL AS FOR POSTDOCS.
IN THIS FORUM I WOULD LIKE TO
ENCOURAGE PEOPLE TO ARE IN AN
UNDERGRADUATE ENVIRONMENT TO
PLEASE ENCOURAGE YOUR STUDENTS
TO CONSIDER THE NIAMS POST-BAC
TRAINING PROGRAM.
THERE'S A WEBSITE WHERE PEOPLE
CAN APPLY.
WE WOULD LOVE TO GET THOSE
APPLICATIONS ESPECIALLY IN THE
NIAMS MISSION AREAS AND WE'RE
ALWAYS LOOKING FOR TALENTED
PEOPLE AND KNOW WE PROVIDE A
VITAL PIPELINE FOR INDIVIDUALS
GOING ON TO FURTHER MEDICAL
SCHOOL OR GRADUATE SCHOOL AND
OTHER PROFESSIONAL TRAINING.
LIKEWISE, WE WOULD ENCOURAGE
ESPECIALLY THOSE OF YOU WHO HAVE
T32s TO INTEREST ENCOURAGING
YOUR TRAINEES TO LOOK TO THE NIH
PROGRAM AS A GOOD PLACE TO
CONTINUE THEIR TRAINING IN THE
NIAMS SPACE AS POSTDOCS.
I WOULD BE PERSONALLY VERY HAPPY
TO HELP HAVE CONVERSATIONS WITH
ANYONE AND TO HELP DIRECT YOU TO
THE RIGHT PLACE.
AND THE LAST POINT I THINK IS A
UNIQUE STRENGTH OF THE NIAMS I
SEE YOU AS THE CONNECTED TISSUE
OF NIH AND A BIT OF A PUN BUT
TRUE.
THE FUNDING FOR OUR
INVESTIGATORS IN AUTOIMMUNE
DISEASE RESEARCH IN PARTICULAR
IS A GREAT EXAMPLE OF THE WAY
THAT WE MAKE BRIDGES ACROSS THE
INSTITUTES AND HOPEFULLY AS WELL
AS NOT JUST BEING A CONNECTED
TISSUE WITHIN NIH AND BETWEEN
INTRAMURAL AND EXTRAMURAL
SCIENCE GOING FORWARD.
TO GIVE YOU MORE SPECIFICITY,
THESE ARE THE TENURED
INVESTIGATORS WITHIN THE NIAMS
IRP.
YOU CAN SEE WITH THE ICONS ON
THE SIDE THEY SPAN THE MISSION
AREAS.
MARCUS TAFNER AND PAUL LINKFIELD
ARE THE MOST BASIC SCIENTISTS
LOOKING AT BASIC BIOLOGY AND
STRUCTURAL BIOLOGY AND PROTEIN
STRUCTURES AND THEN
INVESTIGATORS THAT ARE FOCUSSED
ON BONE AND RHEUMATOLOGIC AND
IMMUNOLOGIC AND LOOKING AT THE
IN CAN AND UNCOVER THE
UNDERLYING MECHANISM.
WE HAVE KEN TURE PRAC
INVESTIGATORS AND OTHERS WHO ARE
AT DIFFERENT STAGES AND TYPES OF
POSITIONS WHO REALLY COMPLEMENT
AND ROUND OUT THE EXPERTISE
ACROSS THE RANGE OF MISSION
AREAS.
NOW, SPEAKING ABOUT THE PROGRAMS
I ALREADY ALLUDED TO AND THE
PROGRAM WHICH IS RICH WITH STAFF
CONDITIONS AND CLINICAL
INVESTIGATORS AND NURSE
PRACTITIONERS THAT FACILITATE
THE CLINICAL RESEARCH THAT
HAPPENS HERE AND I'D MENTIONED
THE RHEUMATOLOGY CONSULT
SERVICE.
TO SUPPORT THE TRAINING MISSION
OF THE INTRAMURAL RESEARCH
PROGRAM WE HAVE THE OFFICE OF
SCIENTIFIC OPERATIONS THE MAIN S
THAT FLOURISH ARE THE POST-BACS
AND POSTDOCS.
IT'S AN EXTRAORDINARY TRAINING
FOR THE GROUPS AND CLINICAL
FELLOWS AN IN MOST YEAR SUMMER
STUDENTS THOUGH THAT IS ON HOLD
FOR THIS YEAR.
THE OFFICE SUPPORT THE RETREAT
OF OTHERS AND THE OTHER IS THE
OFFICE OF SCIENCE AND
TECHNOLOGY.
THIS GROUP OF SCIENTISTS YOU SEE
LISTED ON THE LEFT OVERSEE A
RANGE OF CORPS THAT PROVIDE
INTRAMURAL INVESTIGATORS
EXPERTISE IN GENOMICS.
IT'S ARGUABLE WE HAVE THE BEST
GENOMICS CORPS OF THE NIH AND
IT'S EXCITING THE WAY THEY SEE
SERVICE AND PROPEL THE FIELD
THROUGH THE TECHNOLOGIES THEY'RE
DEVELOPING.
WE HAVE IMMUNOLOGY AND FLOW
CYTOMETRY AND GREAT LIGHT
IMAGING BIO DATA MINING
DISCOVERY AND ANIMAL PROGRAM IN
THE LAST SEVERAL MONTHS I'VE HAD
THE OPPORTUNITY TO WITNESS THE
DEDICATION AND EXPERTISE OF OUR
ADMINISTRATIVE BRANCH LED BY
VALERIE GREEN WHO HAVE BEEN
TIRELESS AND CREATIVE IN TRYING
TO HELP US ALL KEEP GOING AS THE
DIFFERENT CHALLENGES HAVE
EMERGED AND RETAINING A STRONG
ROBUST EXTRAMURAL PROGRAM GOING
FORWARD.
SO SO BECAUSE OF THE WAY THESE
CORE TECHNOLOGIES ARE INTEGRATED
IN THE SCIENCE OF ESSENTIALLY
EVERY PROJECT THE IMPACT AND
QUANTITY IS EXTRAORDINARY.
THIS SHOWCASES VISUALLY SOME OF
THOSE SUCCESSES ACROSS THE 132
THAT HAVE BEEN PUBLISHED IN THE
LAST YEAR EVEN IN THE TIME HERE
WE'VE HAD TWO PAPERS ACCEPTED
FROM OUR EXTRAMURAL
INVESTIGATORS.
ONE UNDERSTANDING THE ROLE OF
MICROBIOME AND PATHOGEN
RESISTANCE ON THE SKIN BY HEIDI
CONG AND ONE LOOKING AT THE ROLE
OF SINGLE LIP IT SIGNALLING IN
NK CELLS AND INFECTION AND
IMMUNITY.
WE'RE PROUD OF THE WAY THIS
SUPPORT SYSTEM ENABLES FANTASTIC
SCIENCE.
HERE'S ANOTHER EXAMPLE FROM ONE
OF OUR LEAD INVESTIGATORS
FOCUSSING ON MUSCLE BIOLOGY AND
I LIKED THE WAY HE TITLED HIS
SLIDE AS AN OVERNIGHT SUCCESS
AND SO YOU CAN SEE THE BENCH AND
SOME IMAGES THAT HIGHLIGHT THE
FUNDAMENTAL RESEARCH HE HAS DONE
WITH THIS GROUP LOOKING AT THE
ROLE OF HISTONE DECETLASE AND
MUSCLE GENE EXPRESSION AND
MUSCLE CELL FUSION AND THEN
CONTINUING ON TO THINK ABOUT THE
WAY INHIBITION OF HVACs USING A
PHARMACOLOGIC AGENT WAS ABLE TO
IMPROVE OUTCOMES IN A MOUSE
MODEL OF MUSCULAR DYSTROPHY AND
MOVING ON INTO PHASE I, II AND
III CLINICAL TRIALS AT THIS
POINT IN 2024, THE FIRST NON
STEROIDAL TREATMENT FOR DUCHENNE
MUSCULAR DYSTROPHY WAS INITIATED
BASED ON THE WORK FROM THIS LAB.
I THINK THIS IS A HALLMARK
EXAMPLE WHERE THE INVESTMENT AND
THE INFRASTRUCTURE OF THE UNIQUE
INTRAMURAL PROGRAM IS POWERFUL
AND IMPORTANT.
THERE'S GREAT ACCOMPLISHMENTS IN
THE PAST YEAR.
A FEW IN PARTICULAR DR. GRAYSON
RECENTLY RESOURCE D RECEIVED
TENURE AND DR. KAPLAN HAS BEEN
ACCEPTED IN THE PROGRAM AND
FUNDING ACCOMPLISHMENTS LISTED
HERE.
THERE ARE MANY OTHERS BUT THOSE
ARE JUST A FEW HIGHLIGHTS I
WANTED TO SHARE.
WE JUST HAD OUR NIAMS INTRAMURAL
PROGRAM RETREAT LAST WEEK.
IT WAS A FANTASTIC OCCASION WITH
ABOUT A HUNDRED POSTERS OVER TWO
DAYS WITH DISTINGUISHED
SPEAKERS, SCIENTISTS AS WELL AS
MEDICAL WRITER FOR THE
ASSOCIATED PRESS WHO CAME TO
INSPIRE AND TEACH US ABOUT THE
WORK THEY'RE DOING.
SO THINKING FORWARD ABOUT THE
NIAMS IRP AS MENTIONED IT'S
ALREADY A VERY STRONG PROGRAM.
BUT THERE ARE SOME THINGS THAT
I'M EXCITED TO IMPLEMENT AND I
THINK IN FUTURE YEARS I'LL COME
BACK WITH MORE SPECIFICITY FOR
YOU ABOUT THOSE.
FOR NOW, ONE OF THE THINGS WE'VE
DONE IS ESTABLISHED THIS
LEADERSHIP CHANGE INCLUDING
MYSELF AND DR. COLBERT AS THE
SCIENTIFIC CLINICAL.
WE HAVE NEW DEPUTY CLINICAL S
FROM DR. KAPLAN AND DR. KONG AND
DR. SARTORELLI TO ALLOW THE MOST
EFFICIENT AND INNOVATIVE USE AND
DEVELOPMENT OF CORE RESOURCES TO
SUPPORT NIH.
ONE THING I WAS INTENTIONAL
ABOUT IS SECURING REPRESENTATION
ACROSS THE DIFFERENT TISSUE
AREAS SO WE CAN REALLY MAKE SURE
THIS SET OF RESOURCES BENEFITS
ALL THE DIFFERENT COMMUNITIES
THAT NIAMS REPRESENTS.
SO WE ARE RIGHT NOW WORKING ON
OUR STRATEGIC PLAN AND WE'LL
COME BACK TO YOU BUT I WILL
SHARE IN THE SHORT TERM THAT WE
INTEND TO FOCUS ON THESE
STRENGTHS AND START THERE.
REALLY LOOKING FOR OPPORTUNITIES
TO ADVANCE HUMAN BIOLOGY, HUMAN
DISCOVERY BIOLOGY USING
MULTI-MODAL APPROACHES AND DATA
SCIENCES AS WELL AS THE -- THE
ACRONYMS KEEP CHANGING THE
SYSTEMS TO LOOK AT THE HUMAN
BIOLOGY SYSTEMS AN IN VITRO
SETTING.
WE'LL CONTINUE TO ADVANCE
INTERACTION ACROSS ENGINEERING
AND LIFE SCIENCES AS WELL AS
ACROSS INSTITUTES KEEPING A
FOCUS ON RIGOR AND EFFICIENCY
AND SUPPORTING THE INVESTMENT IN
TRAINEES AND WORKFORCE
DEVELOPMENT AS WE GO.
FINALLY, I WANTED TO CLOSE NOT
ONLY WITH REMINDING YOU TO
ENCOURAGE POST-BACS AND PEOPLE
INTERESTED IN POSTDOCS TO REACH
OUT TO US SO WE CAN HELP THEM
ACCESS THIS TRAINING ENVIRONMENT
BUT TO LET YOU KNOW WE ARE
LOOKING FOR A MEDICAL
DERMATOLOGIST.
WE HAVE UNFORTUNATELY LOST KEY
MEMBERS OF OUR TEAM IN BEING
ABLE TO SUPPORT THE BUSY CONSULT
SERVICE AND WE WOULD VERY MUCH
BE INTERESTED IN HEARING FROM
YOU IF YOU KNOW OF OR ARE
SOMEONE WHO IS INTERESTED IN
JOINING US HERE IN THE
INTRAMURAL PROGRAM.
SO THANK YOU VERY MUCH.
I'D BE HAPPY TO ANSWER ANY
QUESTIONS.
>> THANK YOU FOR POINTING OUT
DR. SARTORELLIs WORK AND I LOVE
TO PLUG THE NIH SUPPORTED
RESEARCH AND HOW WE GOT THERE
AND THE NEW STEROID DRUG AND
ANOTHER INTRODUCED FOR DUCHENNE
LAST YEAR AND IT'S ALWAYS
IMPORTANT TO PROMOTE THE NIH
RESEARCH.
>> IT'S SATISFYING FOR US TO
HEAR HOW TO THE RESEARCH
DISCOVERIES ARE MAKING A
DIFFERENCE IN YOUR CLINICS AND
IN THE LIVES OF THE PEOPLE YOU
ARE TREATING.
THANK YOU.
>> SO, THANK YOU FOR THE
PRESENTATION AND CONGRATULATIONS
ON MAINTAINING THE MOMENTUM AND
EXCELLENCE IN THE INTRAMURAL
PROGRAM.
IT'S REALLY IMPRESSIVE.
I HAVE TWO QUESTIONS.
HAVE YOU SEEN AN IMPACT ON
APPLICATIONS OR POST-BACS TO
THIS POINT BECAUSE OF THE
CHANGES IN THE LANDSCAPE AND I
ALSO HAD SOME CURIOSITY ABOUT --
SELFISHLY BECAUSE I BOTH WORK IN
THE REGENERATIVE MEDICINE SPACE
AND ALSO AM A BIOMEDICAL
ENGINEER THE DEGREE TO WHICH
ENGINEERING THAT MAY BE APPLIED
FROM BIO MATERIALS TO BIO CHIPS
IS REPRESENTED WITHIN THE
PORTFOLIO OF INVESTIGATOR WITHIN
THE IRP.
>> GREAT QUESTIONS.
ON THE SPECIFIC ABOUT THE
POST-BAC APPLICATIONS I CAN GET
THAT INFORMATION FOR YOU.
I DON'T KNOW IT SPECIFICALLY.
AS YOU ALL KNOW THERE WERE A
NUMBER OF PAUSES ON HIRING,
FIRST OF ALL.
SECONDARILY THEY'VE BEEN LIFTED
ONE BY ONE AND THE POST-BAC
PROGRAM WAS ONE OF THE FIRST
ONES WHERE THE IRP WAS ABLE TO
RECRUIT TALENT FROM INDIVIDUALS
WHO ARE U.S. CITIZENS.
SO IT'S GREAT THAT CHANNEL HAS
OPENED.
I SUSPECT THE UTILIZATION OF
THAT IS LOWER THAN USUAL BECAUSE
IT STARTED SO MUCH LATER THAN IT
USUALLY DOES BUT I'D BE HAPPY TO
GET MORE INFORMATION FOR YOU.
IN TERMS OF POSTDOCS,S THAT WAS
ONE OF THE NEXT THINGS TO OPEN
UP SO WE CAN AGAIN RECRUIT
POSTDOCS TO OUR ASSISTANCE AND
ARE HOPEFUL AS ADDITIONAL HIRING
PAUSES ARE RELIEVED WELL BE ABLE
TO RECRUIT INDIVIDUALS NOT
U.S. CITIZENS TO NIH AS
POSTDOCS.
THAT'S DEFINITELY BEEN AFFECTED.
WE ARE EAGER AND INTENTIONAL
ABOUT KEEPING THOSE PIPELINES
OPEN AND READY TO GO AS SOON AS
THINGS ARE REALLY FREE AGAIN.
SO PLEASE ENCOURAGE PEOPLE TO
REACH OUT BECAUSE I THINK ONCE
THEY GET HERE AS I DID IT'S
QUITE AN IMPRESSIVE PLACE TO DO
SCIENCE.
IN TERMS OF ENGINEERING, I LOVE
YOUR QUESTION.
I'M VERY EXCITED ABOUT THE
OPPORTUNITIES HERE.
ALREADY WITHIN THE NIAMS IRP WE
HAVE INVESTIGATORS WHO HAVE BEEN
USING ESPECIALLY THE RESOURCES
THAT ARE AVAILABLE TO SUPPORT
THOSE KINDS OF RESEARCH THROUGH
NCATS, NIBIB AND OTHERS.
FOR EXAMPLE, ISAAC BURNEL IS
DOING A DRUG SCREEN TO TREAT A
TYPE OF CARCINOMA AND THAT THE
NOT THE ONLY ONE.
I THINK THERE'S TREMENDOUS
OPPORTUNITY TO CONTINUE.
AND IVE TALKED WITH OTHER
LEADERS AND NCATS NIS IS THE
HEART OF WHAT WE DO.
AS WE WANT TO TAKE ADVANTAGE OF
PLATFORM TECHNOLOGIES WE NEED TO
USE THESE WITHIN NIAMS SO I'D
LOVE TO HEAR MORE ABOUT YOUR
IDEAS.
>> I THINK MANY INVESTIGATORS ON
THE EXTRAMURAL SIDE DON'T HAVE
THE APPRECIATION OF THE
INTRAMURAL SIDE AND MY QUESTION
IS ABOUT THAT.
I'VE ALWAYS PERCEIVED THERE'S
TWO ORBITS WITH TWO STRATEGIC
PLANS AND GREAT SCIENCE BUT I
WONDERED IF YOU COULD COMMENT ON
WHETHER THERE'S A FIRE WALL OR
AN ENCOURAGEMENT OF THE TWO
PROGRAMS FROM INTERACTING.
I'M ACTUALLY VERY UNINFORMED
ABOUT THAT.
I DON'T KNOW IF OTHERS ARE.
>> I'M HAPPY TO SPEAK TO THAT
BASED ON A RELATIVELY LIMITED
EXPERIENCE HERE SO FAR.
AS YOU KNOW I HAVE DEEP
EXTRAMURAL EXPERTISE AND WOULD
SAY MY VISIBILITY WAS RELATIVELY
LIMITED UNTIL RECENTLY SO THAT'S
ONE OF THE REASONS I'M EXCITED
TO GIVE THE TALK AND SHARE THIS
PERSPECTIVE ON WHAT IT LOOKS
LIKE FROM INSIDE.
SO I SEE THERE IS A GREAT DEAL
OF OPPORTUNITY TO STRENGTHEN THE
TIES BETWEEN INTRAMURAL AND
EXTRAMURAL INVESTIGATORS TO
ENABLE US TO TAKE ADVANTAGE OF
WHAT EACH ONE DOES BEST.
AND YES, THERE'S A FIRE WALL
FINANCIALLY AND IN THE WAY THE
RESOURCES ARE SPENT THAT WERE
VERY VIGILANT TO MAINTAIN
APPROPRIATE UTILIZATION OF
RESOURCES BUT IN TERMS OF
COLLABORATION, THAT'S
ENCOURAGED, THERE ARE MANY
INTRAMURAL INVESTIGATORS WHO
SERVE AS SIGNIFICANT
CONTRIBUTORS WITHOUT SALARY ON
EXTRAMURAL GRANTS FOR EXAMPLE.
AND THERE ARE SPECIFIC FUNDING
OPPORTUNITIES THAT ENABLE
COLLABORATION.
SO I DON'T WANT TO OVER SPEAK
ALL THOSE DETAILS BUT YES, LET'S
THINK ABOUT WHAT WE CAN DO
TOGETHER.
>> GREAT, I DON'T SEE ANY OTHER
HANDS UP AND IT'S IMPRESSIVE HOW
YOU'VE GOTTEN UP TO SPEED AND
YOUR VISION FOR THE FUTURE.
WE'RE SO GRATEFUL THAT YOU'RE
HERE LEADING THAT IMPORTANT
GROUP.
THANK YOU SO MUCH.
>> THANK YOU.
>> OKAY.
SO I THINK I'M TURNING THINGS
BACK OVER TO DR. SLEDJESKI FOR
THE NEXT PART.
>> YES, THANK YOU VERY MUCH.
SO RIGHT NOW WE'RE GOING TO OUR
OPEN COUNCIL CONCEPT CLEARANCE
AND WHAT WE MEAN AND WHAT THE
FUNCTION IS.
EXTRAMURAL STAFF HERE AT NIAMS
IDENTIFY CRITICAL RESEARCH
OPPORTUNITIES AND NEEDS WITHIN
OUR MISSION AREA.
THE PROGRAM OFFICERS RECOMMEND
CONCEPTS WHICH DESCRIBE THE
BASIC PURPOSE, SCOPE AND
OBJECTIVE OF AN INITIATIVE WE
MAY WISH TO PURSUE AND IT'S THE
PLANNING PROCESS TO RECEIVE
PUBLIC ADVICE AND INPUT ON THE
MERITS OF OUR PROPOSED CONCEPTS
FROM THE COUNCIL.
EVENTUALLY IF CONCEPTS MOVE
FORWARD TO BE AN INITIATIVE
THEY'LL BE PUBLISHED ON OUR
WEBSITE TO LET THE COMMUNITY
KNOW OUR INTERESTS AND FUTURE
FUNDING OPPORTUNITIES.
SO WITH THAT WE HAVE THREE
CONCEPTS WE'RE GOING TO DISCUSS
TODAY.
AFTER EACH ONE WE'LL HOLD A VOTE
TO GET CONCURRENCE FROM COUNCIL
THAT WE'RE ALLOWED TO MOVE
FORWARD WITH THE CONCEPT IF YOU
AGREE WITH US.
I'M GOING TO TURN THIS OVER TO
DR. CAZARIN AND WE'LL SEEK INPUT
FROM COUNCIL MEMBERS REGARDING
THEIR MERIT.
>> THANK YOU FOR THAT.
I THINK WE HAVE A FEW MINUTES
FOR QUESTIONS AFTER EACH OF THE
PRESENTATIONS.
SO IT'S MY PLEASURE TO INTRODUCE
THE FIRST CONCEPT CLEARANCE.
THIS IS GOING TO BE DONE BY
DR. HEIYOUNG PARK ABOUT AN
ANCILLARY STUDY.
I'M GOING TO INVITE THE PROGRAM
DIRECTORS TO COME TO THE TABLE.
>> I'M HEIYOUNG PARK.
I'M A PROGRAM DIRECTOR WHO
ACTUALLY MANAGING
AUTOINFLAMMATORY DISEASES.
THE PRESENTATION IS SEEKING THE
APPROVAL OF A CONCEPT FOR
COUNCIL TO CONTINUE THE PROGRAM
THE NIAMS ANCILLARY STUDIES TO
ONGOING PROJECT THAT DOES NOT
ALLOW CLINICAL TRIALS.
THE CONCEPT CLEARANCE IS
EFFECTIVE FOR FIVE YEARS.
CURRENTLY THE CONCEPT HAS BEEN
EXPIRED.
THE PURPOSE OF THE CONCEPT IS TO
SUPPORT TIME SENSITIVE ANCILLARY
STUDIES RELATED TO THE NIAMS'
MISSION IN CONJUNCTION WITH OR
PUBLICLY FUNDED ONGOING CLINICAL
PROJECTS.
TO MAXIMIZE THE RETURN ON
EXISTING CLINICAL PARENT
PROJECTS.
ALSO, WE WOULD LIKE TO SEE THE
GENERATION OF NEW INFORMATION TO
ENHANCE CLINICAL AND SCIENTIFIC
CONTENT OF THE ORIGINAL PROJECT
TO IMPROVE THE RESEARCH
COMMUNITY'S UNDERSTANDING OF THE
DISEASE OR CONDITIONS WITHIN THE
NIAMS PORTFOLIO AND MAYBE
IDENTIFIED NOVEL TARGETS FOR
DIAGNOSIS, TREATMENT AND
PREVENTION OF DISEASE IN THE
NIAMS MISSION.
SO IN TERMS OF HISTORY OF THE
CONCEPT, NIAMS HAS SUPPORTED
ANCILLARY STUDIES SINCE 2010.
IT'S QUITE A LONG PERIOD OF
TIME.
SO FAR A TOTAL OF 48 GRANTS WERE
AWARDED ACROSS THE NIAMS MISSION
AREA.
AND FOR THE LAST 10 YEARS,
SUCCESS RATE IS ABOUT 22%.
FOR COMPARISON THE NIH SUCCESS
RATE IS ABOUT 17% FOR THE LAST
10 YEARS.
IN TERMS OF THE PERFORMANCE OF
THE ANCILLARY STUDIES IT SHOWED
HIGHER RCR COMPARED TO OTHER
NIAMS FUNDED STUDIES.
RCR IS A MEASURE OF A
PUBLICATION.
IT'S A SPECIFIC PAPER BY
CITATIONS OF ALL NIH FUNDED
PUBLICATION IN THE SAME OR
SIMILAR RESEARCH AREA IN THE
SAME YEAR.
SO AS YOU CAN SEE, ANCILLARY
STUDY R21 PUBLICATION HAS BETTER
RCR.
NEXT ONE IS STUDIES SHOWED THE
HIGHER RCR COMPARED TO OTHER
NIAMS FUNDED STUDIES.
THEREFORE THE RETURN OF OUR
INVESTMENT ON THIS ANCILLARY
STUDY IS MUCH BETTER.
ALSO THE PARENT STUDIES CAN BE
FUNDED BY NIAMS OR OTHER
ENTITIES SO ABOUT HALF OF
ANCILLARY STUDIES WEREN'T FUNDED
OUTSIDE.
THIS SLIDE THOSE MORE SPECIFIC
DESCRIPTION OF PARENT AND
ANCILLARY STUDIES.
PARENT STUDIES IS ONGOING
CLINICAL PROJECT.
IT CAN BE CLINICAL TRIAL OR
CLINICAL OBSERVATIONAL STUDIES
AND CAN BE FUNDED BY PUBLICLY OR
PRIVATELY FUNDED AND CAN BE ON
ANY TOPIC NOT NECESSARILY NIAMS
MISSION.
PARENT STUDIES MUST LAST LONG
ENOUGH TO ACCOMMODATE THE
ANCILLARY STUDY.
IN CONTRAST, ANCILLARY STUDIES
MUST BE WITHIN THE NIAMS MISSION
AND WE ENCOURAGE MECHANISTIC
STUDIES THOUGH WE ALLOW
NON-MECHANISTIC STUDIES.
ALSO IMPORTANTLY THE ANCILLARY
STUDIES MUST HAVE APPROVAL FROM
PARENT PROJECT COMMITTEE AND
MUST NOT INTERFERE WITH THE
PARENT PROJECT OR PARTICIPANTS
AND MUST JUSTIFY TIME
SENSITIVITY.
THIS SLIDE THOSE THE HIGHLIGHT
OF NIAMS ANCILLARY STUDIES.
WE WOULD LIKE TO SEE THE
ENCOURAGEMENT OF COLLABORATION
BETWEEN BASIC AND CLINICAL
INVESTIGATORS AND PARTNERSHIP
WITH PARENT AND PRIVATE ENTITIES
AND ENCOURAGEMENT OF JUNIOR
INVESTIGATORS TO TAKE A LEADING
ROLE IN CLINICAL RESEARCH WITH
THE SUPPORT AND COLLABORATION OF
SENIOR INVESTIGATORS.
SO I'D LOVE TO TAKE ANY
QUESTIONS ABOUT THIS CONCEPT.
>> THANK YOU VERY MUCH.
DO WE HAVE ANY QUESTIONS?
>> I HAD A QUESTION ABOUT THIS
HAS BEEN A VERY SUCCESSFUL
PROGRAM.
IS IT TAPPED AT A LOWER BUDGET
THAN THE TRADITIONAL RO1 OUTSIDE
OF THIS INITIATIVE?
>> YES, RIGHT.
SO PARTICULARLY RO1 MECHANISM WE
ALLOW ONLY FOUR YEARS PROJECT
COMPARED TO ANY OTHER LIKE FIVE
YEARS.
SO BUDGET WISE IS RELATIVELY
SMALLER COMPARED TO REGULAR
PARENT RO1.
THE RETURN ON THE INVESTMENT IS
FLAT BOTTOM.
>> THE ANNUAL BUDGET AND
DURATION OF THE AWARD AT CAPPED
AT ONE ANNUAL TOTAL COST?
>> 400.
>> AND THAT'S WHATTY YOU ARE --
WHAT YOU'RE PROPOSING?
>> YES.
>> THANK YOU.
>> WE HAVE ANOTHER QUESTION.
>> THANK YOU FOR THAT.
REAL QUICK QUESTION.
HOW ARE YOU PLANNING TO REVIEW
THESE?
ADMINISTRATIVELY OR THROUGH THE
PEER REVIEW.
>> THROUGH CENTRALIZED REVIEW.
>> THANK YOU.
>> ARE THERE ANYMORE QUESTIONS.
>> YOU SAID ANY TRAIL, PHARMA OR
ACADEMIC ARE SUPPORTED BUT IS IT
COMPLETELY PHARMA SUPPORTED
TRIAL AND SAMPLES COLLECTED FROM
THE TRIAL.
>> YES, IT IS QUALIFYING.
AS A MATTER OF FACT, THE
COMMITTEE HAS TO CONSENT TO
SUPPORT ANCILLARY STUDIES.
>> THE TIMELINESS FACTOR HAS
BEEN PART OF THIS EFFORT SO IS
THE REVIEW MORE TIMELY OR IS THE
APPROVAL PROCESS ACCELERATED?
>> RIGHT.
SO WHEN WE REVIEWED THE
ANCILLARY STUDIES BY SPECIFIC
REVIEW WE ARE REALLY FORCING
REVIEW BUT RIGHT NOW IT'S GOING
TO BE REVIEWED BY CSR AND AT
LEAST WE CAN HAVE THE AWARDING
PROCESS.
>> ALL RIGHT.
I DON'T THINK WE HAVE ANYMORE
QUESTIONS.
THANK YOU.
>> I'D LIKE FOR A MOTION TO MOVE
THE CONCEPT FORWARD.
>> MOTION.
>> SECOND.
ALL OPPOSED TO THIS MOTION
PLEASE RAISE YOUR HANDS OR SAY
AYE.
I SEE NOBODY OPPOSED HERE OR
ONLINE SO THE MOTION PASSES TO
MOVE FORWARD WITH THE CONCEPT.
THANK YOU VERY MUCH.
>> ALL RIGHT.
THANK YOU.
WE'LL MOVING TO OUR SECOND
CONCEPT CLEARANCE.
THIS IS GOING TO BE PRESENTED BY
DR. ARON MARQUITZ AND THE TITLE
IS RMIP INVESTIGATOR-INITIATED
STUDIES.
>> THANKS, EVERYBODY.
I'M ARON MARQUITZ I MANAGE THE
MUSCULOSKELETAL REGENERATIVE
MEDICINE PORTFOLIO AT NIAMS AND
I'M PRESENTING THE CONCEPT ON
BEHALF A TRANS NIH GROUP OF
PROGRAM OFFICERS THAT MANAGE THE
REGENERATIVE BRING.
I'LL START BY GIVING YOU
BACKGROUND ON WHAT MANY RMIP IS.
IT COMES FROM SPECIFIC
APPROPRIATIONS FROM CONGRESS IN
THE 21st CENTURIES CURES ACT AND
IT'S FOR THE NIH TO ACCELERATE
PROGRESS IN REGENERATIVE
MEDICINE WITH STEM CELLS AND THE
NIH ESTABLISHED THE RMIP FUNDING
HAS TWO KEY CHARACTERISTICS.
ONE IS A SET OF $30 MILLION
AUTHORIZED THAT DOES NOT EXPIRE
WITH ANY FISCAL YEAR SO WE HAVE
IT UNTIL WE USE IT UP AND IT
REQUIRES RECIPIENTS IDENTIFY ONE
TO ONE MATCHING.
SO THEY HAVE TO HAVE SUPPORT
FROM NON FEDERAL FUNDS AND $60
MILLION WORTH OF PROJECTS.
THIS SLIDE HERE JUST SHOWS YOU
SOME OF THE AWARDS THAT HAVE
BEEN MADE BY THE RMIP THUS FAR.
I WON'T GO THROUGH THEM ALL.
THIS STARTED OUT WITH
SUPPLEMENTED IN 2017 AS WE
WORKED ON THE FUNDING
OPPORTUNITIES THEN WE MOVED INTO
BASICALLY TWO KINDS OF FUNDING
OPPORTUNITIES.
ONE FOR CLINICAL TRIALS IN
REGENERATIVE MEDICINE USING
ADULT STEM CELLS AND ONE FOR
PRECLINICAL STUDIES WITH A
PRECLINICAL STUDIES ARE MEANT TO
BE LATE STAGE TRANSLATIONAL IND
ENABLING STUDIES TO PROMOTE MORE
CLINICAL TRIALS IN THE FUTURE.
AND THEN I'LL JUST SAY THAT
NIAMS INVESTIGATORS HAVE BEEN
SUCCESSFUL IN APPLYING FOR RMIP
IN THE PAST AND THERE'S TWO
GROUPS WORKING ON SKIN DISEASES
THAT HAVE BEEN FUNDED AS WELL
TWO GROUPS WORKING ON CARTILAGE
AND NOA.
ANOTHER ASPECT OF THE PROGRAM
WE'RE EXCITED ABOUT IS THE IDEA
OF CHARACTERIZATIONS.
IT'S RATHER UNIQUE.
IN ALL THE FUNDING OPPORTUNITIES
FROM OUR RMIP THUS FAR THE
INVESTIGATORS NEED TO PROVIDE
THE CENTRAL HUB WITH
CHARACTERI
CHARACTERISTICS STEM CELLS FROM
THEIR CLINICAL GRADE PRODUCT AND
THESE GO TO A CENTRAL HUB AND
ARE DEEPLY CHARACTERIZED.
WE ESTABLISHED THE HUB AT
GEORGIA TECH AND THEY DO
ADVANCED OMICS AND ASSAYS AND
OTHER THINGS TO TRY TO
UNDERSTAND THE HETEROGENEITY IN
THE STEM CELL PRODUCT.
THE CHARACTERIZATION IS WHERE
WE'RE PUTTING THE DATA IN THE
NHLBI BIO DATA CATALYST AND IT
WILL BE MADE AVAILABLE TO THE
COMMUNITY AND WE HOPE THIS IS
GOING TO BE A BENEFIT TO THE
BROADER GROUP OF RESEARCH GOING
ON IN REGENERATIVE MEDICINE.
AND I'LL JUST GIVE YOU ONE
EXAMPLE OF THE STUDIES.
I PICKED AN EXAMPLE FROM
DR. GARZA WHO MANY WILL REMEMBER
IS A RECENT MEMBER OF THE NIAMS
COUNCIL HAS AN RMIP PROJECT.
THE POINT IS TO TAKE MOLAR FAB
FIBROBLASTS AND INSECT THEM IN
THE SITE OF AMPUTEES AND ALLOW
FOR BETTER PROSTHETIC USE.
HE'S RECENTLY HAD A PAPER COME
OUT IN SCIENCE WITH SOME OF THE
PRELIMINARY WORK FROM THE STUDY
IN WHICH HE TOOK HEALTHY
CONTROLS FIRST AND TOOK SKIN AND
FIBROBLASTS FROM HEALTHY
CONTROLS AND INJECTED INTO A
SITE OF THESE PARTICIPANTS AND
LOOKED AT WHAT HAPPENED TO THE
SKIN AND LOOKING MECHANICALLY
AND MARKERS IT STARTED TO
DEVELOP PHENOTYPES.
IT SUGGESTS THIS MAY BE A
PROMISING THERAPY AND WE'RE
EXCITED TO SEE THE PROJECT
CONTINUE.
SO THAT'S THE BACKGROUND.
SO WHAT'S THE CONCEPT?
THE CONCEPT WE'RE PROPOSING HERE
IS SHORT TERM FOLLOW-UP STUDIES
FOR THE PROJECTS THAT ARE
CURRENTLY FUNDED IN REGENERATIVE
MEDICINE PROJECT.
SO AS A SAID, WE HAVE THIS
APPROPRIATION FROM THE 21st
CENTURIES CURES ACT.
WE'RE MERELY DONE WITH THE $30
MILLION THAT WE'VE BEEN GIVEN BY
CONGRESS.
WE HAVE SOME SMALL AMOUNT OF
MONEY LEFT.
WHAT WE'D LIKE TO DO IS IDENTIFY
THE AWARDS IN WHICH MOST
SUCCESSFUL THROUGH A PEER REVIEW
PROCESS AND ALLOW THOSE TO
CONTINUE TOWARDS COMPLETION OF
DEVELOPING THE TYPES OF
THERAPIES THAT WERE ORIGINALLY
INTENDED FOR THE PROJECT.
SO I'M JUST GOING TO STOP THERE
AND WILL TAKE ANY QUESTIONS.
>> ARE THERE ANY QUESTIONS?
OKAY.
>> OKAY.
SEEING NO QUESTIONS, SO I'D LIKE
A MOTION TO APPROVE MOVING
FORWARD WITH THIS CONCEPT FOR AN
INITIATIVE?
I SEE A SECOND.
ALL OPPOSED TO THE MOTION PLEASE
RAISE YOUR HAND OR SAY AYE.
SEEING NO ONE OPPOSING IT, THE
MOTION PASSES.
WE CAN MOVE FORWARD WITH THIS.
THANK YOU VERY MUCH.
>> THANK YOU.
ALL RIGHT.
SO FAR, SO GOOD.
WE'LL MOVE TO OUR THIRD CONCEPT
CLEARANCE.
THIS IS GOING TO BE PRESENTED BY
DR. MELISSA GREEN PARKER.
I JUST WANTED TO SAY THAT
DR. GREEN PARKER JOINED NIAMS
DECEMBER 2024 AND TODAY SHE'S
GOING TO BE PRESENTING THIS
CONCEPT ON THE CORE CENTERS FOR
CLINICAL RESEARCH.
>> GOOD MORNING.
I'M MELISSA GREEN PARKER AND
IT'S MY PLEASURE TO COME BEFORE
YOU THIS MORNING.
I'M EXCITED TO SHARE THE
PRESENTATION AS THE GOAL IS TO
SEEK YOUR APPROVAL FOR THE
CONCEPT FOR ONE OF NIAMS
SUCCESSFUL CENTER PROGRAMS
CALLED THE CORE CENTERS FOR
CLINICAL RESEARCH OR CCCR.
THE CORE CENTERS FOR CLINICAL
RESEARCH HAVE AN OVER ALL GOAL
TO ADVANCE PREVENTION, DIAGNOSIS
AND TREATMENT OF NIAMS RELEVANT
DISEASES AND DISORDERS BY
FOSTERING THE IMPLEMENTATION OF
METHODS, METRICS AND MEASURES
THAT ADDRESS CRITICAL CLINICAL
RESEARCH NEEDS.
DOING SO THOUGH WITH PROJECTED
KNOWLEDGE GAPS AS WELL AS THE
BROAD STAKEHOLDER VIEWS IN MIND.
IN FY17, NIAMS ESTABLISHED THE
CCCR PROGRAM IN ORDER TO ENHANCE
METHODOLOGICAL SCIENCES THAT
SUPPORT CLINICAL RESEARCH WITHIN
AND ACROSS THE NIAMS PORTFOLIO
OF DISEASES AND TO DATE 10 NEW
TYPE 1 GRANTS HAVE BEEN AWARDED
ALONG WITH SEVERAL COMPETITIVE
RENEWAL GRANTS.
LOCATED IN ALL THE MAJOR
QUADRANTS ACROSS THE UNITED
STATES, THESE CENTERS ADDRESS A
NUMBER OF RESEARCH AREAS WITHIN
NIAMS' MISSION INCLUDING JOINT
REPLACEMENT, LUPUS AND PEDIATRIC
RHEUMATOLOGY.
THE GENERAL STRUCTURE OF THE
CCCR FEATURES A STRONG
METHODOLOGICAL CORE THAT
PROVIDED INNOVATIVE APPROACHES
AS WELL AS THE NECESSARY
EXPERTISE FOR SUPPORTING LOCAL
RESEARCH PROJECTS.
THE CENTERS ALSO INCLUDE AN
ADMINISTRATIVE CORE LED BY TWO
DIRECTORS WHO HAVE THE
FLEXIBILITY TO ORGANIZE CENTER
ACTIVITIES AROUND A CENTRAL
SCIENTIFIC THEME OR TO SUPPORT
STUDIES TO ADDRESS PRESSING
RESEARCH NEEDS WITH COMMUNITY.
MOREOVER, PATIENT AND COMMUNITY
REPRESENTATION IS INCORPORATED
THROUGHOUT THE PROJECT,
IMPLEMENTATION AND FORMALIZED
WITH THE COMMITTEE AND THERE'S
OPTIONAL COMPONENTS FOR RESEARCH
CORES AND PILOT AND FEASIBILITY
PROJECTS.
SO YOUR CONSENT TO REISSUE THE
CCCR PROGRAM WILL REPRESENT
NIAMS' COMMITMENT TO ADVANCING
METHODOLOGICAL SCIENCE
CRITICALLY SUPPORT CLINICAL
RESEARCH WITHIN OUR PORTFOLIO OF
DISEASES.
AND CONTINGENT ON OUR
AVAILABILITY OF FUNDS OUR TEAM
STANDS READY TO ISSUE NEW AWARDS
IN FY27 AND FURTHERMORE WE
WELCOME YOUR FEEDBACK AND OTHER
COMMENTS VIA THE CENTRAL NIAMS
COUNCIL ADDRESS SHOWN ON THE
SCREEN.
AND HAPPY TO ANSWER ANY
QUESTIONS.
>> THANK YOU SO MUCH.
ANY QUESTIONS?
>> YES.
>> I WAS WONDERING WHAT TYPE OF
EVALUATION OF THE OF THE P30 YOU
CAN SHARE.
>> IT'S A MY UNDERSTANDING AN A
MORE FORMAL EVALUATION HAS NOT
BEEN CONDUCTED SINCE 2013
HOWEVER, WE DID HOLD A WORKSHOP
IN DECEMBER OF LAST YEAR WHERE
WE RECEIVED FEEDBACK FROM
GRANTEES AND SO FORTH ABOUT WAYS
IN WHICH THEY WOULD LIKE TO SEE
SOME OF OUR CENTERS' PROGRAMS
EVOLVE.
>> CAN I ADD TO THAT POINT VERY
QUICK JUST DO CLARIFY AGAIN
BECAUSE MELISSA JOINED US AFTER,
THIS WAS AN INTERNAL WORKSHOP
WITH OUR DIRECTORS AND NIAMS
STAFF.
WE'RE LOOKING INTO WAYS TO
FORMALIZE AND EVALUATION OF THE
CENTERS SO YES, THAT'S WHERE WE
STAND.
ANYMORE QUESTIONS?
>> I'LL ALSO JUST ADD THAT THESE
CONCEPT CLEARANCES ARE AT A VERY
HIGH LEVEL.
AS YOU CAN SEE THEY'RE
PROJECTING IN THE FUTURE WHEN
CURRENT CONCEPTS WOULD EXPIRE
AND IT GIVES US PLENTY OF TIME
AND THE INTENTION IS NOT TO TALK
ABOUT THE SPECIFICS BUT PLENTY
OF TIME TO DECIDE HOW THEY'LL
BEST SUPPORT THE COMMUNITY.
UNDERSTANDING THE IMPACT THESE
HAVE HAD IN THE PAST AND EQUALLY
IMPORTANT, TRYING TO UNDERSTAND
WHAT'S NEEDED NOW WILL BE PART
OF THE WORK THAT WE UNDERTAKE
LEADING UP TO FISCAL YEAR '27
BUT WE NEED A LOT OF ADVANCED
NOTICE TO GET APPROVAL SO WE CAN
BEGIN THE WORK THAT WOULD ENABLE
US TO RENEW THESE WITHOUT A GAP
IN FUNDING.
>> DO WE HAVE ANYMORE QUESTIONS
HERE?
>> OKAY.
LET ME CALL FOR A VOTE THEN.
SO DO WE HAVE A MOTION I SEE A
MOTION AND SECOND.
THANK YOU VERY MUCH.
ALL OPPOSED TO THE MOTION SAY
AYE OR RAISE YOUR HAND.
SEEING NONE THE MOTION PASSES
AND WE CAN MOVE FORWARD AND I'M
SURE WE'LL BE HEARING MORE ABOUT
THIS.
THANK YOU VERY MUCH.
MARY, ANY LAST WORDS?
>> NOPE.
I JUST WANT TO THANK THE PROGRAM
DIRECTORS FOR THEIR WORK IN
CLEARING THE CONCEPT.
>> WE HAVE SCHEDULED NOW A
15-MINUTE BREAK.
I THINK RIGHT AFTER THAT HEAR
ABOUT THE HEAL STRATEGIC PLAN
AND THANK YOU VERY MUCH.
LET'S TAKE A BREAK AND WE'LL SEE
YOU BACK HERE AT 11:36.
>> THANK YOU.
SO I'M NOW GOING TO BE CALLING
ON DR. ANNA MAZUKO FOR OUR HEAL
PAIN STRATEGIC PLANNING
PRESENTATION.
ANNA.
>> THANK YOU VERY MUCH.
I'M VERY CLEAVED TO PRESENT OUR
NEXT TWO SPEAKERS TODAY.
SO FIRST JUST A LITTLE BIT OF
BACKGROUND, ON THE PRESENTATION.
THE NIH HEAL INITIATIVE WHICH
WAS LAUNCHED IN 2018 HAS MADE
SIGNIFICANT PROGRESS IN A SHORT
PERIOD OF TIME AS DESIGNED IN
THE HEAL ANNUAL REPORTS BUT IT
MUST CONTINUE TO EVOLVE TO KEEP
PACE WITH THE DYNAMIC AND
CHANGING LANDSCAPE IN OVERDOSE
AND CHRONIC PAIN.
THAT END HEAL EMBARKED ON THE
DEVELOPMENT OF A NEW STRATEGIC
PLAN IN 2024.
AS PART OF THAT EFFORT, A
COMMITTEE WAS CONVENED ON THE
NATIONAL ADVISORY NEUROLOGICAL
DISORDERS AND STROKE COUNCIL.
THIS HEAL PAIN STRATEGIC
COMMITTEE ENGAGED IN A PROCESS
TO PROPOSE AND PRIORITIZE
FORWARD LOOKING STRATEGIC
RESEARCH PRIORITIES FOR THE NEXT
PHASE OF PAIN RESEARCH SUPPORTED
BY THE NIH HEAL INITIATIVE.
AND I'D LIKE TO ALSO JUST
BRIEFLY MENTION THAT SEVERAL
NIAMS PROGRAM DIRECTORS AND
ANALYSTS ALSO CONTRIBUTED TO
THAT PROCESS.
THAT INVOLVED WORKING WITH
EXPERTS FROM THE RESEARCH
COMMUNITY AND PEOPLE WITH LIVED
EXPERIENCE OF PAIN TO INFORM THE
FINAL RESEARCH PRIORITIES.
THE EXECUTIVE COMMITTEE
CONSIDERED AND APPROVED THE
PROPOSED RESEARCH PRIORITIES
JUST A FEW WEEKS AGO AT THE MAY
14, 2025 MEETING OF THE NIAMS
COUNCIL.
THE FINAL REPORT FROM THE
EXECUTIVE COUNTY IDENTIFIES THE
MOST PROMISING DIRECTIONS FOR
FUTURE HEAL SUPPORTED PAIN
RESEARCH.
THE APPROVED PRIORITIES WILL
HELP GUIDE THE DEVELOPMENT OF A
FIVE YEAR STRATEGIC PLAN FOR THE
NIH HEAL INITIATIVE.
TO SHARE WITH YOU ALL TODAY MORE
ABOUT THE RESEARCH PRIORITIES, I
WOULD LIKE TO INTRODUCE THE
CO-CHAIRS OF THE HEAL INITIATIVE
PAIN STRATEGIC PLANNING
COMMITTEE WHO HAVE GRACIOUSLY
AGREED TO PRESENT TO US ABOUT
THESE PRIORITIES TODAY.
THEY'LL BE PROVIDING AN UPDATE
ON RECOMMENDATIONS FOR PAIN
RESEARCH PRIORITIES FOR THE HEAL
INITIATIVE IN THE FORTHCOMING
HEAL STRATEGIC PLAN.
DR. SUKA PROFESSOR OF FISCAL
THERAPY AND REHAB AND PROFESSOR
OF NEUROSCIENCE AND PHARMACOLOGY
AT THE UNIVERSITY OF IOWA IN
IOWA CITY CARVER COLLEGE OF
MEDICINE.
HER LABORATORY STUDIES THE
PERIPHERAL MECHANISMS OF
SKELETAL PAIN AND
NON-PHARMACOLOGIC USE FOR PAIN
AND PROJECTS IN HUMAN SUBJECTS.
IN 2024, HAVE SLUKA WAS CHOSEN
AS ONE OF SIX RECIPIENTS OF THE
HEAL AWARD FOR MENTORSHIP FOR
RESEARCHERS WHO DEMONSTRATE
EXCEPTIONAL COMMITMENT TO THE
DEVELOPMENT AND MENTORSHIP OF
EARLY YEAR SCIENTISTS IN THE
PAIN AND ADDICTION RESEARCH
FIELDS.
I'D ALSO LIKE TO INTRODUCE HER
CO-CHAIR DR. GEREAU, VICE CHAIR
FOR RESEARCH AND DIRECTOR OF THE
WASHINGTON UNIVERSITY PAIN
CENTER AND PROFESSOR THE
ANESTHESIOLOGY AT THE MEDICINE
DEPARTMENTANCE THESIOLOGY AND
ELE TROE PHYSIOLOGY AND
OPTOGENETICS AND IMAGING AND --
I THINK THAT'S DR. KIEL WHO JUST
JOINED.
TO UNDERSTAND THE SIGNALLING
PATHWAYS INVOLVED IN NERVOUS
SYSTEM PLASTICITY AND PAIN
SENSITIZATION TO IDENTIFY NOVEL
APPROACHES TO REVERSE THIS
MALADAPTIVE PLASTICITY TO
PROVIDE NEW THERAPEUTIC STRATEGY
TO REDUCE PAIN AND ITS IMPACT ON
PATIENT QUALITY OF LIFE.
WORK IN THE LAB ALSO INCLUDES
CLINICAL SCIENCE AIMED AT
TRANSLATING FINDINGS FROM THE
LAB INTO NEW OR IMPROVED
THERAPIES FOR PATIENTS WITH
PAIN.
THANK YOU, KATHLEEN AND ROB FOR
JOINING US TODAY AND WE LOOK
FORWARD TO HEARING MORE ABOUT
THE PAIN STRATEGIC PLANNING
PROCESS.
SO WITH THAT WE'LL HAND IT OVER
TO KATHLEEN AND ROB.
THANK YOU SO MUCH.
>> THANK YOU FOR THE OPPORTUNITY
TO BE HERE.
I'LL GIVE MORE DETAIL ON THE
BACKGROUND BUT THAT WAS A GREAT
INTRODUCTION AND THEN WE'LL DIVE
IN AND DISCUSS THE RESEARCH
PRIORITIES THAT CAME OUT NEF
PROCESS.
I'LL GIVE YOU BACKGROUND AND
FRAMEWORK FOR HOW WE WENT
THROUGH THIS PROCESS.
WITH THAT AND THE HEAL
INITIATIVE LAUNCHED AND CONGRESS
ADDED AN ADDITIONAL $5 MILLION
TO THE BASIC APPROPRIATION OF
NIH TO HAVE A NEW INITIATIVE FOR
THE DEVELOPMENT OF OPIOID
ALTERNATIVES AND PAIN MANAGE.
AND DIRECTIVE TREATMENT.
THAT WAS A FAST ROLL OUT AT THE
BEGINNING OF HEAL FROM THE
INCEPTION TO THE FUNDING TO
HAVING TO LAUNCH AND SO THE
INITIAL INVESTMENTS IN HEAL
AROUND PAIN WERE GUIDED BY A
COUPLE OF THINGS THAT HAD
FORTUNATELY JUST BEEN COMPLETED
WHICH WAS THE FEDERAL PAIN
RESEARCH STRATEGY OF 2017 AND
ALSO BASED ON A SERIES OF WHAT
WERE CALLED SCIENCE MEETINGS TO
END THE OPIOID CRISIS AND THOSE
DISCUSSIONS TOGETHER WITH THE
FEDERAL PAIN RESEARCH STRATEGY
HELPED TO FORM THE BASIS OF
PROJECTS THAT WERE GOING TO BE
TAKEN ON FOR PAIN RESEARCH UNDER
HEAL WHICH HAS A SPECIFIC
MANDATE DIFFERENT FROM WHAT IS
FUNDED FROM THE INSTITUTES AND
CENTERS NORMALLY.
THOSE DISCUSSIONS INFORMED THE
STUDY IN JAMA.
FROM 2018 TO 2023 IT WAS MANAGED
THROUGH THE OFFICE OF THE
DIRECTOR AND THEREAFTER WAS
MANAGED IN NIDA AND NINDS FROM
DR. KOROSHETZ AND ONE OTHER.
THERE'S BEEN GREATER THAN 2200
RESEARCH PROJECT IN ALL 50
STATES TOTALLING OVER $3.9
BILLION IN INVESTMENT.
IMPORTANTLY INVOLVES
COLLABORATION ACROSS NIH
INSTITUTES, CENTERS AND OFFICES.
IN TERMS OF METRICS OF OUTCOMES
THERE'S OVER 40 FDA APPROVALS
FOR INVESTIGATIONAL NEW DRUGS OR
DEVICES AND OVER 300 CLINICAL
TRIALS UNDERWAY OR HAVING JUST
COMPLETED.
SO WITH THAT RAPID LAUNCH, MANY
OF THOSE INITIAL PROJECTS
ESPECIALLY THE CLINICAL TRIALS
WHICH TAKE A FEW YEARS TO RUN,
THOSE ARE KIND OF WRAPPING UP OR
AT A TRANSITION POINT TO THE
NEXT PHASE.
AND BASED ON THAT THE HEAL
MULTI-DISCIPLINARY WORKING GROUP
DEVELOPED A NEW STRATEGIC PLAN
AS AN INCLUSIVE WAY PROVIDE
INPUT TO GUIDE FUTURE HEAL
INVESTMENTS AROUND PAIN
RESEARCH.
THERE'S ANALYSIS ON HOW PAIN
RESEARCH HAD BEEN GOING BECAUSE
THERE WERE QUESTIONS WHETHER
HEAL INITIATIVE FUNDING SHIFT
THE LOCUS OF WHERE THE FUNDING
COMES FROM BUT AS THIS SLIDE IS
INDICATING, YOU'RE SEEING THE
TREND LINE FOR THE OVER ALL NIH
BUDGET IN THE BLUE LINE AND
SALMONY COLORED LOWER BARS IS
THE FUNDING FOR PAIN THAT COMES
FROM THE NIH INSTITUTES AND
CENTERS AND THE TEAL BAR ON TO
THE TOP REPRESENT THE ADDITIVE
FUNDING TO HEAL.
YOU CAN SEE PAIN RESEARCH
FUNDING TRENDED CONSISTENT WITH
OVER ALL NIH FUNDING AND IT WAS
ADDITIVE TO ABOUT WHAT WAS
ALREADY GOING ON WHICH IS
APPROPRIATE BECAUSE HEAL HAS A
DIFFERENT GOAL AND THE MISSION
STATEMENT IS IN THE BOX.
YOU CAN SEE HEAL PAIN RESEARCH
AIMS TO REDUCE PAIN AND THE RISK
OF OPIOID USE DISORDER BY
DEVELOPING SAFE AND EFFECTIVE
PAIN TREATMENTS AND PREVENTION
STRATEGY TO IMPROVE QUALITY OF
LIFE FOR ALL PEOPLE.
IT'S VERY MUCH FOCUSSED ON
DEVELOPMENT MUCH NEW AND
REFINEMENT AND VALIDATION OF
EXISTING THERAPIES TO PICK THE
BEST TREATMENT AND GET NEW
TREATMENTS TO PEOPLE AS QUICKLY
AS POSSIBLE.
THE GOAL IS TO SPEED THERAPY
IMPROVEMENT FOR PAIN.
SO WHAT ARE EXAMPLES OF THE HEAL
PORTFOLIO?
THERE'S FARPHARMACOLOGIC APPROAS
VALIDATED FOR PAIN ANEW
ACETAMINOPHEN ANALOG AND THE
INHIBIT ERS IN CLINICAL TRIAL
AND LIGANDS DEVELOPED IN TERMS
OF PHARMACOLOGIC APPROACHES
NON-OPIOID TARGETS.
THERE'S BEEN A BIG INVESTMENT IN
WE HEARD ABOUT THIS EARLIER
FOCUSSED ON HUMAN BIOLOGY BUT
THE HEAL INITIATIVE WENT INTO
THIS IN GENERATING DATA IN
PROTEINS AND DEVELOPED A SENSORY
NEURONS ACROSS SPECIES INCLUDING
HUMANS WHERE WE DEVELOPED A REAL
TIME CHRONIC PAIN SIGNATURE
COVID BY STROKE OR AMPUTATION
AND BIOMARKERS TO ALLOW THE
DISTINGUISHED AGING AND
DEGENERATIVE CHANGES ASSOCIATED
WITH CHRONIC LOW BACK PAIN AND
THERE'S OPTIMIZATION FOR
HOME-BASED TRANSCUTANEOUS
STIMULATION FOR ABDOMINAL PAIN
AND FDA CLEARANCE OF A DEVICE TO
TREAT CHRONIC PAIN.
OVER 40 CLINICAL TRIALS.
MANY OF WHICH ARE WRAPPING UP
THIS YEAR.
WON'T GO INTO DETAIL THERE BUT
ALSO A BIG INVESTMENT IN THE
PAIN WORKFORCE WHICH IS
SOMETHING THAT WAS NEEDED AND
THAT'S REALLY HELPED MOVE THE
NE
NEEDLE THERE.
WITH THAT NOTION WAS TAKING A
MOMENT TO LOOK AT WHAT HEAL HAS
DONE WELL AND WHAT THE GAPS ARE
AND WHAT HAS BEEN MISSED AND TO
REALLY PROVIDE BROAD STAKEHOLDER
ENGAGEMENT IN THE PROCESS.
THE WORKING GROUP THE HEAL PAIN
STRATEGIC WORKING GROUP WAS
MENTIONED AS A WORKING GROUP OF
THE ADVISORY COUNCIL AND ONE OF
THE FIRST THINGS WE DID WAS GET
A REQUEST FOR INFORMATION OUT
THERE TO GET INPUT FROM
STAKEHOLDERS AND THAT WAS OPEN
FOR A PERIOD OF TIME AND WE
COLLECTED THAT INFORMATION AND
THAT WORKING GROUP THEN CONVENED
AROUND SCIENTIFIC AREAS TO
INFORM SEVEN SUBCOMMITTEES BASED
ON INFORMATION FROM INSIDE NIH
AND THE REQUEST FOR INFORMATION.
WE HAVE A FOCUS AREA INCLUDING
ADDITIONAL PUBLIC INPUT ON THE
SPECIFIC SUBCOMMITTEES.
SO SO, THE WORKING GROUP THEN
TOOK THE INFORMATION AND
SUBCOMMITTEES DETERMINE THE
FINAL LIST OF RECOMMENDATIONS
AND JUST PRESENTED THIS TO NINDS
COUNCIL AS AN OFFICIAL LIST OF
RECOMMENDATIONS WE'LL GO OVER
WITH YOU TODAY.
ALL OF THIS WILL BE USED TO
GENERATE NOTICES OF FUNDING
OPPORTUNITIES IS THE PLAN FOR
FISCAL YEAR '27 AND BEYOND.
SO THAT WAS THE SCOPE.
THESE ARE THE MEMBERS OF THE
SUBCOMMITTEES AND MEMBERS OF
VARIOUS SUBCOMMITTEES.
THEY'RE AS FOLLOWS.
HEATH EQUITY AND PAIN ACROSS THE
LIFE COURSE AND NON-ADDICTIVE
THERAPEUTICS AND BIOMARKERS AND
PREDICTORS, ANOTHER ON
OPTIMIZATION OF INTERVENTION TO
IMPROVE PAIN.
ONE ON IMPLEMENTATION AND HEALTH
SERVICES, ONE ON THE
INTERSECTION OF PAIN AND
SUBSTITUTE USE DISORDER ARE A
CRITICAL GOAL FOR THE HEAL
INITIATIVE AND ANOTHER AREA
FOCUSSED ON PAIN RESEARCH
WORKFORCE AND TRAINING.
YOU CAN SEE THE CO-CHAIRS AND
DR. SLUKA AND THE COMMITTEE AND
THE LIVED EXPERIENCES ADVISER
FOR THE PROCESS.
THEY EACH HAD A SEVERAL HOURS
LONG WORKSHOP THAT HAD MEMBERS
OF THE PUBLIC AVAILABLE THERE.
EACH TOOK INFORMATION AND WE
SOUGHT ADDITIONAL INFORMATION TO
EACH OF THE SUBCOMMITTEES TO
DEVELOP A SET OF PRIORITIES
WITHIN THE GROUPS.
WE TOOK THE RECOMMENDATIONS AND
THERE WAS OVERLAP NOT
SURPRISINGLY AND WENT THROUGH A
PROCESS TO PRIORITIZE THOSE
RECOMMENDATIONS BASED ON THEIR
ABILITY TO ADVANCE THE HEAL PAIN
MISSION.
THE EXECUTIVE COMMITTEE DID THE
WORK AND CAME UP WITH PRIORITIES
GOING FORWARD BASED ON THAT
PROCESS ALONG WITH A SET OF CORE
PRINCIPLES THAT HELP ADVANCE THE
HEAL PAIN MISSION.
THE CORE PRINCIPLES ARE CROSS
CUTTING AND CAME UP TIME AND
AGAIN.
THESE ARE THINGS THAT ARE TO BE
CONSIDERED IN THE CONTEXT OF ALL
THE RESEARCH GOING ON.
FIRST BEING THE INVOLVEMENT OF
PEOPLE WITH LIVED EXPERIENCE AND
NIH HEAL RESEARCH INCLUDING
TRAINING OF INVESTIGATOR ON HOW
TO WORK WITH PEOPLE WITH LIVED
EXPERIENCE THE INCLUSION OF
LIVED EXPERIENCE THROUGH DATA
ANALYSIS AND THE WHOLE PROCESS.
THERE'S A LOT OF ENERGY AROUND
PUBLIC EDUCATION FOR PUBLIC AND
PROVIDERS.
THERE ARE A NUMBER OF
METHODOLOGICAL PRINCIPLES FOR
PRE CLINICAL AND CLINICAL TRIAL
RESEARCH MENTIONED.
YOU CAN SEE THE REPORTING OF
SEX, LONGER TERM OUTCOMES FOCUS
ON PAIN ACROSS THE LIFE SPAN AND
NEEDS TO BE MIMICKED IN PRE
CLINICAL WORK AND CO-OCCURRING
CONDITIONS IN THE MODELS.
THE INFLUENCE OF SOCIAL FACTORS
AND THAT WILL COME UP LATER
AROUND ANTIGRATING PRINCIPLES
INTO ALL CLINICAL TRIALS AND USE
OF TEAMS TO CATALYZE ON UNIQUE
SKILLS AND METHODOLOGIES AND
EMPHASIS ON ALLOWING AND
ENCOURAGING SECONDARY ANALYSIS
OF DATA SETS AND SAMPLES MANY OF
WHICH ARE ALREADY STORED IN THE
HEAL DATA ECO SYSTEM AND THOSE
ARE CAREER PRINCIPLES.
WITH THOSE IN MIND, WE'LL DIVE
INTO THE RESEARCH PRIORITIES.
THESE WERE PRESENTED TO YOU HERE
IN NO PARTICULAR ORDER JUST THE
TEN THAT CAME TO THE TOP OF THE
PILE.
I'LL GIVE THE FIRST FEW AND
WE'LL FINISH UP.
THE FIRST WAS TO SUPPORT CAREER
AWARDS INCLUDING
NON-U.S. CITIZENS TO GROW THE
PAIN WORKFORCE.
WE WANTED TO FOSTER THE
CONTINUED GROWTH OF ESTABLISHED
PAIN RESEARCHERS AND PROVIDE
TARGETED OPPORTUNITIES FOR
INDIVIDUALS WITH NO PRIOR PAIN
RESEARCH EXPERIENCE BUT STRONG
POTENTIAL TO DEVELOP IMPACTFUL
CAREERS IN PAIN SCIENCE WE'VE
SEEN POSITIVE RESULTS FROM
PEOPLE FROM OTHER FIELDS AND
BRINGING NEW EXPERTS AND THAT
WAS EVOLVED TO FOCUS ON THAT.
PEOPLE THAT WAS A GOOD OUTCOME
FOCUSSED ON PAIN WORKFORCE
GROWTH IN THE FIRST PHASE OF
HEAL AND WAND TO EXPAND THAT IN
THESE DAYS.
THE NEXT IS TO SUPPORT
MECHANISTI
MECHANISTICALLY PHARMACEUTICAL
MODALITIES.
DEVELOPING NEW THERAPIES FOR
PAIN BUT EXPANDING THE MODAL
MODALITIES BEYOND SMALL
MOLECULES.
INCORPORATING ANTIBODY BASED
THERAPIES, mRNA THERAPIES AND
PROTEIN DEGRADATION WERE
DISCUSSED IN THE GROUP AND THE
HEAL INITIATIVE DEVELOPED A
WHOLE ECO SYSTEM FOR TAKING
TARGETS IDEAS FROM TARGET
MOLECULES AND VALIDATING THEM
AND THERE'S BIG SUPPORT FROM
ENABLING PROCESS TO ALLOW
THERAPEUTIC DEVELOPMENT IN
ACADEMIA AND IN SMALL START UPS
BECAUSE IT BROUGHT NEW
MODALITIES AND TARGETS FORWARD
BUT WANT TO EXPAND THAT TO WHERE
THESE OTHER NEW THERAPEUTIC
MODALITY INCLUDED BECAUSE
THERE'S A LOT OF OPPORTUNITY
THERE.
I MENTIONED EARLIER THE BIOLOGY
WAS A BIG PART OF WHAT WAS
HAPPENING IN THE FIRST PART OF
HEAL AND THEY WANT TO CONTINUE
THE INVESTMENT FOCUSSED ON HUMAN
BIOLOGY TO SUPPORT THE
DEVELOPMENT OF NOVEL
THERAPEUTICS FIRST BY
IDENTIFYING HIGH QUALITY TARGETS
FOR THE DEVELOPMENT OF NEW
EFFECTIVE PAIN THERAPEUTICS AND
TO ALLOW REVERSE TRANSLATION IN
THAT UNDERSTANDING THE HUMAN
BIOLOGY AROUND PAIN CONDITIONS
WILL ALLOW THE DEVELOPMENT OF A
NEW GENERATION OF MUCH MORE
PREDICTIVE DISEASE SPECIFIC
ANIMAL AND CELLULAR MODELS THAT
WILL HELP TO ADVANCE THE FIELD.
I'LL PASSIVE OFF TO HAVE SLUKA
DO MOVE AHEAD.
BEING -- TO MOVE AHEAD.
>> I'LL MOVE ON WITH OUR NEXT
PRIORITIES.
THESE TEND TO SPAN SOME MORE
CLINICALLY BASED PRIORITIES.
THE FIRST ONE IS TO DEVELOP WAYS
TO PREVENT THE DEVELOPMENT OF
CHRONIC PAIN.
THROUGHOUT THE LIFE SPAN IN REAL
KEY TRANSITION PHASES ACROSS THE
LIFE COURSE AND THIS IS A BIG
THING.
WE WOULD HAVE TO DEVELOP AND
TEST SCREENING TOOLS AND
BIOMARKERS AND DEVELOP
STRATEGIES THAT COULD PREVENT
THE DEVELOPMENT OF PAIN ONCE WE
KNOW WHAT THOSE RISKS AND
BIOMARKERS ARE CAN WE TARGET
THEM AND THEN CHANGE AND REDUCE
THE TRANSITION RATES BECAUSE
RIGHT NOW TRANSITION RATES ARE
20% TO 40% DEPENDING ON HOW YOU
CALCULATE IT AND THE CONDITION
THEN WE WOULD NEED TO TEST OTHER
STRATEGIES GEARED TOWARDS
PREVENTING IT TOGETHER WITH
LIFESTYLE CHANGES SIM IS --
SIMILAR TO CARDIOVASCULAR
DISEASE AND PREVENTING IT BEFORE
OR AFTER AN ACUTE INJURY OR
SURGERY AND COULD TREAT THEM
FIRST BEFORE THE SURGICAL EVENT
OR AT THE TIME OF THE INITIAL
TRAUMA AND THIS LEADS ITSELF TO
PRE CLINICAL STUDIES TOO THAT
COULD BEGIN TO EXAM MECHANISMS
AND BIOMARKERS IN THAT
TRANSITION PHASE TO CHRONIC
PAIN.
THE NEXT WILL BE ABOUT
BIOMARKERS.
YOU CAN SEE OVERLAP BETWEEN THEM
BUT THEN THERE'S SOME NOVELTIES
WITH EACH OF THEM.
AND THIS WILL BE ABOUT
DEVELOPING PREDICTORS FOR
TREATMENT RESPONSE SO WE ALL
KNOW NOT EVERYBODY RESPONDS TO
ALL TREATMENTS ONLY ABOUT 40% TO
50% RESPOND TO ANY ONE TREATMENT
SO IF WE CAN PICK THOSE WHO DO
RESPOND WE CAN IDENTIFY PEOPLE
WHO WILL RESPOND IN AND BETTER
SELECT THE TREATMENTS.
SO WE'RE LOOKING FOR TREATMENT
RESPONSE PREDICTORS, SAFETY OR
TARGET ENGAGEMENT AND COULD
SERVE AS SURROGATE END POINTS IN
CLINICAL TRIALS.
THESE COULD BE INCORPORATED INTO
ALL OF OUR CLINICAL TRIALS.
IT WILL REQUIRE RIGOROUS
VALIDATION.
WE KNOW THERE'S A BIOMARKER
PROGRAM THAT SUPPORTS THIS THAT
HAS ALREADY STARTED IN THE FIRST
PHASE OF HEAL A NUMBER OF
BIOMARKER STUDIES THAT COULD BE
CONTINUED AND TAKE THIS TOTS
NEXT STAGE.
WE AT A TAILORED MECHANISM BASED
APPROACH SHOULD IMPROVE
OUTCOMES.
IN MEDICINE PRACTICES THIS WAY
THEY PICK TARGETS BASED ON THE
MECHANISM OF THE DISEASE BUT A
LOT OF NON-DRUG THERAPIES ARE
JUST KIND OF THROWN AT THAT AS
WELL WITHOUT KNOWING NECESSARILY
HOW THEY ALL WORK.
SO THIS PRIORITY IS REALLY TO
EVALUATE WHETHER INDIVIDUALIZED
TAILORED MECHANISM BASED
APPROACH ARE BETTER THAN JUST
THE STANDARD APPROACH THAT WE
USE TODAY.
IN ORDER TO DO THIS WE HAVE TO
DEVELOP DEVELOPTHE COMPLEXITY A
CAPTURE THE NATURE OF PAIN AND
THE INDIVIDUALITY OF PAIN AND
LOOK AT MECHANISMS UNDERLYING
NON-PHARMACOLOGIC INTERVENTIONS
TO BE TARGETED TO THE PHENOTYPES
AND SIGNATURES.
THEN LOOK AT THE SIGNATURE WITH
TREATMENTS AIMED AT THE
MECHANISMS AND EXPECT A MULTI
DISCIPLINARY APPROACH LOOKING AT
MECHANISMS OF THE DRUG DEVICES
AS WELL AS THE PHARMACEUTICAL
TREATMENTS TOGETHER.
THE OTHER THING WE KNOW IS
MULTI-MODAL APPROACHES WE THINK
ARE USEFUL AND BETTER THAN JUST
THE SINGLE TREATMENT APPROACH
YET WE DON'T REALLY KNOW WHAT
TREATMENT SHOULD BE GIVEN WHEN
AND UNDER WHAT CONDITIONS AND
THIS IS VALIDATING AND TESTING
EVIDENCE-BASED GUIDELINES ON THE
APPROPRIATE INITIAL THERAPY AND
ORDER AND TIMING OF THE
MULTI-MODAL APPROACHES AND ALSO
THE NON SPECIFIC EFFECTS AND HOW
TO MAXIMIZE THEM TO ACHIEVE A
MAXIMAL BENEFIT FOR THE
INDIVIDUAL WITHOUT UNDUE RISK.
WE WOULD HAVE TO LOOK AT
TREATMENT RESPONSE AND ALREADY
TALKED ABOUT THAT IN A PRIORITY
AND NOT SINGLE INDIVIDUALIZED
APPROACHES AND EVALUATE ALL
THERAPIES PARTICULARLY NON DRUG
APPROACHES AND UNDERSTAND THE
NON SPECIFIC EFFECTS AND THEIR
INFLUENCE.
THERE WAS ALREADY A CLINICAL
EFFECTIVENESS NETWORK THAT HAS
DONE A COUPLE OF STUDIES ON THIS
IN PROGRESS OR WRAPPING UP NOW
AND THERE'S A PRISM NETWORK
APPROACH TO SUPPORT THESE
STUDIES WELL.
THIS IS ON IMPROVING CLINICAL
OUTCOME AND TAKING THE
EVIDENCE-BASED TREATMENTS AND
FIGURE OUT IF THEY WORK WHEN YOU
PUT THEM IN THE REAL WORLD AND
LOOKING AT HYBRID IMPLEMENTATION
AND EFFECTIVENESS STUDIES OF
PRAGMATIC TRIALS THAT WOULD
IMPACT SCALABILITY AND
SUSTAINABILITY.
SO THE GOAL IS TO NOT ONLY KNOW
WHAT WORKS BUT GET THEM IN THE
CLINIC AND ALIGN WITH METRICS TO
MEANING
MEANINGFUL EFFECT AND PAYERS AND
HEALTH CARE SYSTEMS AND PEOPLE
ONE LIVED EXPERIENCE AND A
PARTNERSHIP TO GET THESE
INTEGRATED.
WE WOULD ASSESS SHARED DECISION
MAKING TOOLS CLINICIANS TALK
ABOUT AS BEING VALUABLE AND IN
IMPROVING OUTCOMES BUT HAS NOT
TESTED WELL AND EVALUATE THE
INTEGRATIVE CARE MODELS IN THE
COMMUNITY SETTINGS TO SEE
WHETHER OR NOT THEY ACTUALLY
WORK BETTER THAN WHAT THEY'RE
DOING NOW AND A KEY FACTOR THAT
CAME OUT OF THIS WAS NOT ONLY
WOULD WE IMPLEMENT THE HIGH
VALUE INTERVENTIONS BASED ON
CLINICAL EVIDENCE WOULD BE
COUPLED WITH DE-IMPLEMENTATION
OF LOW VALUE, HIGHER RISK PAIN
INTERVENTIONS.
IT WAS THOUGHT YOU CAN'T JUST
TAKE OUT SOMETHING WITHOUT
SOMETHING TO REPLACE IT.
IT WAS AN IMPORTANT PART OF
THESE PRAGMATIC TRIALS AND THE
CLINICAL EFFECTIVE NETWORK ARE
ALREADY IN PLACE TO HELP SUPPORT
THESE NEXT STAGE STUDIES.
THIS IS AN INTERSECTION BETWEEN
SUBSTITUTE USE DISORDER AND
PAIN.
MANY PEOPLE WITH SUBSTANCE USE
DISORDER HAVE PAIN AND SOME TAKE
PAIN THERAPEUTICS AND PAIN
ITSELF AND SUBSTANCE USE
DISORDER CAN IMPACT PAIN.
THERE'S AN INTERACTION BETWEEN
THE TWO.
THE PRIORITY IS ABOUT
IDENTIFYING POPULATIONS THAT ARE
DISPROPORTIONATELY IMPACTED BY
PAIN AND SUBSTANCE USE.
UNDERSTANDING THE MECHANISM
DIFFERENTLY IMPACT THE
POPULATIONS AND DEVELOP AND
INTERVENTIONS TO ADDRESS THIS
IMPACT.
THIS WOULD ENTAIL PRIORITIZING
THE HIGHLY IMPACTED POPULATION
AND THE RESEARCH INTERSECTION
BETWEEN SUBSTANCE USE AND
INTERVENTION FOR HIGH POTENTIAL
FOR IMPACT AND DEPRESCRIBING
OPIOIDS AND REPLACING IT -- YOU
CAN'T JUST DE PRESCRIBE IT
WITHOUT REPLACING IT WITH
SOMETHING LIKE MULTI-MODAL CARE
AND PRE CLINICAL STUDIES
DEVELOPING NOVEL INTERVENTIONS
AND ADDRESS THE MECHANISMS OF
THAT RELATIONSHIP.
INVESTIGATE EVIDENCE-BASED,
INFORMED APPROACHES AND APPLYING
THEM EQUALLY TO ALL INDIVIDUALS
THAT ADDRESS THE OPIOID
COMPLEXITY AND ENGAGING HEALTH
EQUITY EXPERTISE AND COMMUNITY
ENGAGEMENT.
COMMUNITY ENGAGEMENT IS
PARTICULARLY BENEFICIAL FOR THIS
POPULATION.
AND I THINK THIS IS THE LAST
PRIORITY AND THIS IS REEL THIS
CALLS OUT SUPPORTING NON-DRUG
APPROACH TO THE TREATMENT AND
PREVENTION OF CHRONIC PAIN.
WE TALK ABOUT NON-DRUG
APPROACHES BEING VALUABLE AND
NECESSARY AND KEY TO THIS BUT
THEY'RE EMBEDDED IN OTHER THINGS
AND SOMETIMES GET LOST IN THE
MIX.
THE SUPPORT FOR THIS ONE IS TO
REALLY LOOK AT NON-DRUG
APPROACHMENT TO TREATMENT
INTERVENTION WHICH WOULD INCLUDE
THOSE WITH CO-OCCURRING
SUBSTANCE USE DISORDER.
WE WOULD HAVE TO IDENTIFY
EXISTING EVIDENCE-BASED
APPROACHES AND TAILOR THESE
USING HYBRID IMPLEMENTATION
TRIALS AND WOULD HAVE TO
EVALUATE THE UNDERLYING
MECHANISMS OF THESE IN PRE
CLINICAL AND CLINICAL STUDIES.
WE HAVE LOOKED AT RESPONDER
ANALYSIS AND WHO RESPONDS AND
DOESN'T RESPOND WITH PREDICTORS
IN BIOMARKERS WHICH COULD
IMPROVE THEIR USE AND
IMPLEMENTATION IN A MORE
INDIVIDUALIZED APPROACH.
AND THEN AGAIN WE'RE LOOKING AT
OPTIMAL TIMING OF INITIATING THE
INTERVENTION AND ROLE OF SHARED
DECISION MAKING IN
PERSON-CENTERED CARE.
AS YOU CAN SEE ALL THE
PRIORITIES HAVE A BIT OF AN
OVERLAP AND SOME INDIVIDUALIZED
APPROACHES BETWEEN THEM.
NEXT, SO THIS SUMMARIZES OUR 10
PRIORITIES.
I KIND OF THOUGHT ABOUT THIS.
WE HAVE PRIORITY BASED ON
TRAINING THAT'S NEEDED IN THE
PAIN FIELD TO MOVE THIS FIELD
FORWARD AND HAVE PRIORITIES ON
DRUG DEVELOPMENT AND HAVE
PRIORITIES ON BIOMARKERS AND
PREDICTORS OF CHRONIC PAIN AND
TREATMENT RESPONSE.
AND THEN WE HAVE THINGS TO
IMPROVE THE TREATMENT OF THOSE
WITH EXISTING PAIN OR PREVENT
THE DEVELOPMENT OF CHRONIC PAIN
ALTOGETHER.
AND THEY ALL INVOLVE A
MULTI-MODAL APPROACH AND INVOLVE
KIND OF AN INDIVIDUALIZED KIND
OF PATIENT CENTERED APPROACH
WITH THE ULTIMATE GOAL OF THAT'S
WHERE I THINK WE'LL END UP IF WE
CAN GET THE DATA TO SUPPORT
THAT.
THERE WAS A BIG GROUP THAT
WORKED HARD.
EVERYBODY CONTRIBUTED AN AMAZING
AMOUNT OF WORK TO MAKE THIS
HAPPEN.
THERE WAS A HUGE NIH STAFF ACT
WANT TO THANK THOSE WHO HELPED
TO GET THE DOCUMENT TOGETHER
PARTICULARLY JACKIE WARD WHO WAS
OUR GO-TO AT NINDS PRIOR TO HER
LEAVING.
WITH THAT I THINK THAT IS MY
LAST SLIDE.
WE THANK YOU.
THIS IS OUR EXECUTIVE COMMITTEE
MEETING WHERE WE MET IN THE
MIDDLE OF THE WINTER.
THERE WAS SNOW ALL OVER THE
GROUND SO WE'RE ALL WEARING OUR
CASUAL CLOTHES AND BIG BOOTS TO
GET HERE BUT IT WAS A WONDERFUL
MEETING AND WE WANT TO THANK
EVERYBODY FOR DOING IT.
WE'RE HAPPY TO ANSWER QUESTIONS,
TAKE THOUGHTS.
I SEE CLAPPING.
>> I HAVE A QUESTION.
IT'S REGARDING PRIORITY NUMBER 9
WHERE YOU TALK ABOUT POPULATIONS
THAT ARE DISPROPORTIONATELY
AFFECTED BY PAIN.
I'M WONDERING BASED ON THE DATA
THAT I'M AWARE OF THAT THERE'S A
BIT OF BIAS REGARDING PAIN
MANAGEMENT AMONG ETHNIC
COMMUNITIES PARTICULARLY AFRICAN
AMERICANS WHO MAY NOT RECEIVE
PAIN AS REQUESTED IN HOSPITALS
UPON THE THOUGHT IT MAY BE MORE
OF SUBSTANCE ABUSE RATHER THAN
AFRICAN AMERICANS HAVING A
HIGHER TOLERANCE OF PAIN THAN
OTHER GROUPS.
ARE YOU LOOKING AT ALL
POPULATIONS AND THEN MAKING A
MEASURE OF WHERE WHERE THERE MAY
BE AN ISSUE AROUND SUBSTANCE
ABUSE AND PAIN MANAGEMENT AND
TOLERANCE FOR PAIN?
>> YES, THAT'S VERY BROAD.
INDEED WE TALKED A LOT ABOUT S
AND THE DISPARITIES IN HEALTH
CARE AMONG DIFFERENT RACES,
ETHNICITIES, WOMEN, MEN AND IT'S
MEANT FOR REALLY TO LOOK AT ALL
OF THAT WHETHER OR NOT THERE ARE
DIFFERENCES IN HOW AFRICAN
AMERICANS PER SE ARE TREATED,
HOW THEY'RE APPROACHED.
DO WE NEED A DIFFERENT STRATEGY.
DO WE NEED TO CHANGE AND LOOK AT
IMPLEMENTATION DIFFERENTLY TO
GET THAT BACK INTO PRACTICE?
SO FOR SUBSTANCE USE AND PAIN
TREATMENT BECAUSE WE RECOGNIZE
THE DISPARITIES ACROSS MULTIPLE
DIFFERENT POPULATIONS INCLUDING
AFRICAN AMERICANS, HISPANICS,
OLDER FOLKS WHO ALSO GET A
LITTLE BIT LOST IN THE MIX
SOMETIMES TOO.
>> ANY OTHER QUESTIONS FROM THE
GROUP?
THERE WAS A MOVE TO DIVERSIFY
AWAY FROM SMALL MOLECULES AND
WONDERING IF AV MEDIA AND GENE
THERAPY WOULD BE ONE OF THEM?
>> YEAH, THAT'S CERTAINLY IN
PLAY.
THERE'S CAPABILITY AND
PRIORITIZATION.
I THINK THERAPIES ARE HAVING A
MOMENT BUT THERE'S DIFFERENT
MODALITIES AND ENCOURAGING
INNOVATION IN THAT SPACE BECAUSE
I THINK DIFFERENT APPROACHES ARE
NEEDED FOR SOME OF ESPECIALLY
SOME OF THE PAIN TARGETS AND
GENE THERAPIES.
SOMETHING IN PLAY THERE.
YEAH.
>> I'D LIKE TO THANK ROBERT AND
KATHLEEN FOR THE TREMENDOUS
AMOUNT OF WORK THEY UNDERTOOK TO
DO THIS.
CAN YOU IMAGINE?
THIS WAS A HUGE EFFORT AND WE'RE
SO GRATEFUL BECAUSE OF THE
OPPORTUNITIES THIS WILL PROVIDE
FOR ALL OF NIH AND WE AT NIAMS
FEEL PAIN IS SO CENTRAL AND SO
IMPORTANT TO MANY OF OUR
DISEASES AND CONDITIONS SO WE
WANTED TO TAKE THIS OPPORTUNITY
TO MAKE YOU ALL AWARE AND HOPE
WE CAN TAKE ADVANTAGE OF THE
INVESTMENT AND TIME AND EFFORT
TO CHART A PATH FORWARD ALSO FOR
THOSE NEW TO COUNCIL OR AREN'T
FAMILIAR WITH THE HEAL PROGRAM
WERE GOING TO CALL OUT PREVIOUS
AND ONGOING INVESTMENTS WE'VE
BEEN ABLE TO LEAD AND CREATE BY
VIRTUE OF HEAL RESOURCES.
THERE'S THE BACPAC RESEARCH
PROGRAM FOR LOW BACK PAIN AND
SUCCESSFUL EFFORT HUGE TEAM
FUNDED.
THERE'S ANOTHER EFFORT CALLED
REJOIN THAT NIAMS IS DEEPLY
INVOLVED IN TRYING TO UNDERSTAND
MORE ABOUT THE INNERVATION
WITHIN TISSUES AND SPECIFIC
JOINTS.
MOVING FORWARD THERE'S AN EFFORT
ON CHRONIC PAIN IN CHILDREN THAT
WE'RE EXCITED ABOUT AND WE'RE
ALSO INCREASINGLY TRYING TO
THINK IN A MORE INTEGRATED
FASHION AS WE MOVE FORWARD WITH
SOME OF THESE VARIOUS HEALS
EFFORT AND MORE OF AN
INTEGRATIVE MUSCULOSKELETAL PAIN
EFFORT WE'RE HELPING MOVE
FORWARD.
WE'VE ALREADY BENEFITTED SO MUCH
FROM THESE RESOURCES AND LOOK
FORWARD TO TAKING ADVANTAGE OF
THE TIME AND EFFORT THESE
WORKING GROUPS HAVE DEVOTED TO
CHART A PATH FORWARD FOR US.
SO THANK YOU SO MUCH.
>> THANK YOU FOR HAVING US.
>> WITH THAT I'LL TURN IT BACK
TO LINDSEY.
I THINK WE HAVE TIME FOR MORE
QUESTIONS BEFORE THE END OF THE
OPEN SESSION.
>> YES, OUR CURRENT PLANS
INVOLVE BREAKING FOR LUNCH AT
12:45 AND LEAVES ALMOST HALF AN
HOUR, IF WE'D LIKE TO HAVE IT TO
RAISE QUESTIONS ABOUT TOPICS
MENTIONED, DISCUSSED TODAY, NEW
TOPICS, THINGS YOU WANT US TO BE
THINKING ABOUT, CONCERNS YOU
HAVE WE HAVEN'T TOUCHED UPON,
IDEAS FOR TOPICS FOR FUTURE
MEETINGS, ETCETERA.
SO WOULD ANYBODY LIKE TO SPEAK
UP?
>> THANK YOU FOR THE OPPORTUNITY
TO BE HERE.
IT'S AGAIN AMAZING TO GET A LOOK
BEHIND THE CURTAIN AND HEAR
ABOUT THE WORK AND RESEARCH
BEING DONE AT NIAMS.
MY QUESTION IS ABOUT DATA
SCIENCE.
SO I ASK THIS A BIT SELFISHLY AS
SOMEONE WHO DOES ADMINISTRATIVE
RESEARCH AND I THINK IT'S CALLED
OUT IN PRIORITY 3 TO ENHANCE THE
EXPERTISE IN DATA SCIENCE AND
HOW WE USE IT SO I WAS CURIOUS
TO HEAR MORE ABOUT THE
INITIATIVES THAT ARE MAYBE IN
PLACE HERE AT NIAMS TO ENHANCE
IT AND ADVANCE THE SCIENCE
ESPECIALLY IN MUSCULOSKELETAL
CONDITIONS.
>> I'M MAKE A COUPLE COMMENTS
AND THEN MAYBE ANNA OR OTHERS
WANT TO CHIME IN.
I MENTIONED FAIRLY BRIEFLY
DURING MY REPORT THE SYS BIO
EFFORT FOCUSSING ON DATA
INTEROPERABILITY WHICH IS A
CRUCIAL ISSUE AND ROAD BLOCK NOW
AND THAT IS RESONATING WELL
ACROSS THE NIH AND WITH
LEADERSHIP AND OFFICE OF
DIRECTOR OF STRATEGY AND NEW
PRINCIPLE DIRECTOR HAD AN
OPPORTUNITY TO HEAR A
PRESENTATION ABOUT SYS BIO AND
EXPRESSED INTEREST IN THE
PROGRAM.
THOSE FOLLOWING WHAT'S BEEN
SHARED, WHAT LITTLE HAS BEEN
SHARED SO FAR, WE'RE ONLY A FEW
MONTHS INTO THE TENURE OF THE
CURRENT NIH DIRECTOR, HE IS VERY
INTERESTED IN REAL WORLD DATA
AND TALKING ABOUT A REAL WORLD
DATA PLATFORM THAT WOULD SUPPORT
UTILIZATION OF DATA AND
TECHNICAL CHALLENGES.
WE HEARD MENTION OF FOCUS ON
AUTISM AND A FOCUS OF THE REAL
WORLD DATA INITIATIVE AND
THERE'S A LOT OF DISCUSSION
ABOUT THE NEED, THE
OPPORTUNITIES AND WE'RE
FOLLOWING THAT VERY CLOSELY BUT
LET ME LET ANN AND OTHERS WHO
WANT TO CHIME IN ABOUT OTHER
THINGS AND BY THE WAY WE HAD A
WORKING GROUP OF COUNCIL FOLKS
IN DATA SCIENCE PRIOR TO
COMPLETION OF OUR STRATEGIC
PLANNING PROCESS THAT WAS USEFUL
AS WELL.
>> THANK YOU SO MUCH FOR THAT
QUESTION AND I CAN ELABORATE A
LITTLE FURTHER ON DR. CRISWELL'S
COMMENTS.
DR. CRISWELL ACTUALLY PRESENTED
JUST ABOUT A MONTH AGO TO
DR. BHATTACHARYA, OUR NEW NIH
DIRECTOR AND THE OTHER NIH
INSTITUTE DIRECTORS AND
HIGHLIGHTED THE SYS B BIO PROGRM
IN ADDRESSING USERABILITY ACROSS
NIH AND THAT'S ONE FACET OF DATA
SCIENCE ACTIVITIES AT NIH BUT I
THINK WE'RE REALLY EXCITED TO
CONTINUE TO PARTICIPATE IN THAT
AND AS DR. CRISWELL SAID IT
CERTAINLY IS A PRIORITY FOR OUR
NEW LEADERSHIP AND SOMETHING
WHERE WE'RE REALLY ENGAGED
WORKING WITH OUR COLLEAGUES NOT
ONLY AT OTHER NIH INSTITUTED BUT
IN THE OFFICE OF THE DIRECTOR
THERE'S AN NIH OFFICE OF DATA
SCIENCE STRATEGY SO ACTUALLY
DR. CRISWELL CO-CHAIRS THE SYS
BIO EFFORT AND THEY'RE WORKING
ON A RANGE OF DATA SCIENCE
ISSUES.
AND THERE'S HEAL INITIATIVES AND
NIAMS PROGRAMS WE'VE BEEN ABLE
TO PARTICIPATE IN OVER THE YEARS
AND WANTING TO HAVE MORE
INTEGRATIVE RESOURCES FOR
MUSCULOSKELETAL PAIN IS ANOTHER
EXAMPLE WHERE WE TRIED TO REALLY
TAKE ADVANTAGE OF THE RESOURCES
THROUGH THE HEAL DATA ECHO
SYSTEM AND MAKE SURE -- ECO
SYSTEM AND MAKE SURE OUR
PROGRAMS AND REJOIN AND BACPAC
ARE FULLY LEVERAGING AND
INTEGRATED INTO THAT EFFORT AND
THAT WE CAN FOCUS ON WAYS TO
CONTINUE TO TAKE ADVANTAGE OF
THOSE RESOURCES AND MAKE THEM
MORE ACCESSIBLE TO THE NIAMS
COMMUNITIES.
THAT'S JUST A FEW EXAMPLES BUT
CERTAINLY SOMETHING WE'RE
WANTING TO CONTINUE FOCUSSING
ON.
>> A KNOWLEDGE PORTAL IN TERMS
OF INTEROPERABILITY AND MAKE
MORE ACCESSIBLE THE RICH DATA
FROM THE VARIOUS AMP PROGRAMS
AND THE PORTAL STANDS FOR
ARTHRITIS AND AUTOIMMUNE RELATED
KNOWLEDGE PORTAL ARK, AND WE'RE
CONTINUING TO PUSH REALLY HARD
TO SUPPORT ITS FURTHER
DEVELOPMENT FOR THE RESEARCH
COMMUNITY.
THANKS FOR ASKING ABOUT THAT.
>> SO I WAS INTRIGUED BY THE
HEAL INITIATIVE'S RECOMMENDATION
TO EXPAND TRAINING PROGRAM WHICH
IS GREATLY NEEDED AND TO
INCORPORATE NON-U.S. CITIZENS IN
THE TRAINING PROGRAM WHICH I
THINK IS CRITICAL GIVEN WE'RE
FACING A SHORTAGE OF RESEARCHERS
IN THE COUNTRY AND CURIOUS OF
THOSE NIRINITIATIVES MAY EXTENDT
TO OTHER INITIATIVES AND HOW IT
MAY BE INCORPORATED.
IT'S A GREAT OPPORTUNITY TO
EXPAND THE TALENT POOL.
>> YEAH, THANK YOU FOR PICKING
UP ON THAT.
AND I AGREE THAT'S A VERY
IMPORTANT CONSIDERATION TO US
CONSIDERING THIS CHANGING
LANDSCAPE, ETCETERA.
BUT AS YOU'RE PROBABLY ALSO
AWARE, WE'RE WORKING THROUGH A
LOT OF CHALLENGING ISSUES
RELATED TO INTERACTIONS,
COLLABORATIONS WITH FOREIGN
ENTITIES THROUGH SUBAWARDS AND
THE CONCERN IS WITH CAN'T TRACK
THE FUNDS.
WHAT HAPPENS TO THE FUNDS AFTER
THEY GO OUT TO A SUB AWARD.
THERE'S BEEN SOME DISCUSSIONS AS
DR. ALLISTON IS AWARE IN TERMS
OF OUR TRAINEES AND SITUATIONS
WHERE WE'RE HOST TRAINEE BEING
PAID BY ANOTHER COUNTRY, SOME
CONFLICTS OF INTEREST THERE.
SO THERE'S A LOT OF TRICKY
SECURITY AND OTHER ISSUES WE'RE
WORKING THROUGH BUT I HOPE WHEN
WE GET TO THE OTHER SIDE OF SOME
OF THOSE DISCUSSIONS WE CAN
CIRCLE BACK AND TALK ABOUT THE
COMMUNITIES PRESENTED TO US BY
REACHING OUT TO THE BROADER
COMMUNITY.
I'M SURE YOU'LL HEAR MORE ABOUT
THE TOPIC AND I'M NOT SURE WHEN
ROB AND KATHLEEN ARE STILL ON
BUT IS THERE WAS AN UPDATE IN
THE ADMINISTRATION AND
PRIORITIES AND FOCUS AREAS.
THERE'S AN OPPORTUNITY TO BRING
NEW TALENT AND STRENGTHEN THE
WORKFORCE.
THAT'S A RECOMMENDATION AND I
THINK IT'S GOING TO HAVE TO BE
HOW IT'S INACTED IN THE CONTEXT
OF THE PROGRAMS WILL HAVE TO BE
IN LINE WITH THE GUIDANCE AND I
THINK THE MECHANISM THE GOAL IS
THE SAME.
THE MECHANISM OF HOW WE GET TO
THAT HAS TO BE WORKED OUT.
OUR SENSE IS THIS IS WHAT WE'RE
SUPPOSED TO BE DOING AND YOU
MAKE IT HAPPEN AS BEST WE CAN.
>> OTHER QUESTIONS FOLKS HAVE?
OKAY.
I'M NOT SEEING ANY OTHER HANDS.
LET ME CONFER WITH DARREN.
WE'RE 15 MINUTES AHEAD OF
SCHEDULE.
SHOULD WE CLOSE OUT AND BREAK
EARLIER FOR LUNCH AND KEEP WITH
THE 45 MINUTE LUNCH PLAN?
>> THAT'S FINE WITH ME.
DO YOU WANT 45 MINUTES OR AN
HOUR FOR LUNCH?
>> KEEP IN MIND YOU HAVE TO GO
DOWN TO THE CAFETERIA IN THIS
BUILDING AND GET YOUR LUNCH AND
BRING IT BACK UP.
>> SO WE'LL COME BACK AT 1:30
WHICH WAS OUR SCHEDULED TIME TO
START CLOSED SESSION.
>> OKAY.
>> I WANTED TO HIGHLIGHT OUR
GRANTS MANAGEMENT STAFF.
THEY DON'T OFTEN GET HIGHLIGHTED
OR HEARD ABOUT MUCH BUT HAVE
BEEN DOING AN AMAZING JOB TRYING
TO IMPLEMENT A LOT OF THE
CHANGES THAT ARE HAPPENING
ESPECIALLY ERIC AND SAHAR OUR
CHIEF AND DEPUTY.
SO IS JUST THINK ABOUT THEM TOO
THE GRANTS MANAGEMENT STAFF ARE
WORKING MARD TO GET STUFF DONE
AND IT'S ONLY GOING TO GET
HARDER BECAUSE WE'RE AT THE END
OF THE FISCAL YEAR WHICH IS
ALWAYS TOUGHER FOR GRANTS
MANAGEMENT STAFF.
IF YOU SEE A GRANTS MANAGEMENT
SPECIALIST OR TALK TO ONE JUST
SAY THANK YOU.
>> I COULD NOT AGREE MORE ABOUT
THAT COMMENT.
YOU MIGHT WANT TO THINK OF
PUTTING YOURSELVES IN THEIR
SHOES THEY'VE BEEN DOING A
FABULOUS JOB SUPPORTING YOU ALL
AND US.
THEY'RE AMAZING.
THANK YOU.
OKAY.
I THINK WE CAN OFFICIALLY CLOSE
OUT OPEN SESSION WITH THE GAVEL.
MAKES IT OFFICIAL AND THANK YOU
ALL FOR JOINING US AND I HOPE
YOU ENJOY YOUR LUNCH BREAK AND
CHAT AND COME BACK WITH OTHER
IDEAS YOU MAY WANT TO DISCUSS.
THANK YOU ALL FOR JOINING US ON
THE VIDEOCAST.