>>WELCOME TO 112th NIAMS COUNCIL
>>I WOULD LIKE TO REMIND
EVERYBODY THAT IF YOU'RE
CAMERA'S ON WE CAN SEE YOU.
IF YOUR MICROPHONE IS ON WE CAN
HEAR YOU.
IF YOU ARE NOT SPEAKING, PLEASE
LEAVE YOUR MICROPHONE MUTE.
IF YOU'RE IN THE COUNCIL AND AT
THE TABLE PLEASE LEAVE YOUR
CAMERA ON AND WITH THAT I WILL
TURN IT OVER TO DR. LINDSAY
CRISWELL.
>>GOOD MORNING AND WELCOME
EVERYONE.
OKAY.
I WILL NOW CALL THE 112th
MEETING OF THE NATIONAL
ARTHRITIS AND MUSCULOSKELETAL
AND SKIN DISEASES ADVISORY
COUNCIL TO ORDER.
AS YOU MAY 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 WHICH
WE'LL BE ADDRESSING IN CLOSED
SESSION THIS AFTERNOON.
BUT BEFORE WE PROCEED, I'D LIKE
ALL COUNCIL MEMBERS WHO ARE
JOINING US TO INTRODUCE YOURSELF
AND START WITH LEE
>>I'M LEE CALLAHAN FROM THE
UNIVERSITY OF NORTH CAROLINA,
CHAPEL HILL.
>>GOOD MORNING I'M BETH
McNALLY.
>>I'M FROM THE UNIVERSITY OF
CALIFORNIA SAN FRANCISCO UCSF
ASSISTANT PROFESSOR.
>>JOHN O'SHAY SCIENTIFIC
DIRECTOR OF NIAMS.
>>I'M DARREN SLEDJESKI.
>>I'M GAIL LESTER THE DIRECTOR
OF EXTRAMURAL RESEARCH AT NIAMS.
I'M A PROFESSOR OF BIOMEDICAL
ENGINEER AT GEORGIA TECH EMORY.
>>I'M AT A PROFESSOR AT THE
ANDERSON CENTER.
>>STEPHANIE BURNS FROM THE
POLICY AND ANALYSIS BRANCH.
>>LET ME CALL OUT NAMES OF
FOLKS ONLINE.
DR. STAEVA.
>>I'M A V.P. AND CHIEF
SCIENTIFIC OFFICER AT THE LUPUS
ALLIANCE IN NEW YORK CITY.
>>DR. GRECO.
>>I'M MEDICAL SCHOOL OF
GENETICS.
>>THIS IS ANN ELDERKIN WITH THE
AMERICAN SOCIETY OF BONE AND
MINERAL RESEARCH.
>>I'M IN THE DEPARTMENT OF
ORTHOPEDIC SURGERY AT HARVARD
MEDICAL SCHOOL.
>>SORRY ABOUT THAT.
DR. GARZA.
>>LUIS GARZA DEPARTMENT OF
DERMATOLOGY JOHNS HOPKINS.
>>I'M DEPUTY DIRECTOR OF NIAMS.
GLAD TO BE WITH YOU.
>>AND DR. GOODMAN.
>>STUART GOODMAN DIRECTOR OF
BIO ENGINEERING, STANFORD
UNIVERSITY.
>>I THINK I GOT EVERYBODY.
DR. SUAREZ, I THINK YOU
INTRODUCED YOURSELF.
DO YOU WANT TO DO IT AGAIN?
>>MARIA SUAREZ UNIVERSITY OF
TEXAS ANDERSON CANCER CENTER.
>>GOOD MORNING.
WELCOME EVERYONE.
THIS IS OUR FIRST OFFICIAL
HYBRID COUNCIL MEETING.
WE DO HAVE FIVE COUNCIL MEMBERS
IN THE ROOM WITH US TODAY AS
WELL AS STAFF AND THE REST OF
THE MEMBERS ARE ATTENDING.
WE ARE ALL SIGNED INTO ZOOM AND
WE'RE EXPERIMENTING WITH THE SET
UP.
SOME STAFF ON THE ZOOM CALL THIS
MORNING AND OTHERS AS WELL AS
THE PUBLIC WHERE ALSO WATCHING
VIA LIVE VIDEOCAST.
IF ANY STAFF MEMBER WATCHING ON
THE VIDEOCAST OR ANYONE ELSE HAS
AN URGENT COMMENT OR QUESTION
E-MAIL NEIL.ROBERTS@NIH.gov AND
HE'LL REFER THE QUESTION TO ME.
EXCEPT FOR THE SPEAKER WE ASK
YOU TURN OFF YOUR VIDEO AND
SPEAKER AND DURING PRESENTATION
WE ASK YOU TURN ON YOUR VIDEO TO
SEE EVERYBODY PARTICIPATING.
ANYBODY VIEWING THIS, WE
ENCOURAGE YOU TO SUBMIT
QUESTIONS IN WRITING UP TO 15
DAYS FOLLOWING THE MEETING.
WE HAVE A SPECIAL MAILBOX TO
RECEIVE YOUR COMMENTS.
THEY CAN BE SENT TO
NIAMSCOUNCILMAIL AT NIH.COM AND
WE'RE ALSO GOING TO ASK OUR
COUNCILS TO KEEP YOUR VIDEO ON
DURING PRESENTATION.
IF YOU NEED HELP WITH THE
ELECTRONIC COUNCIL BOOK CONTACT
NEIL WHO WILL BE SEATED AT THE
REGISTRATION TABLE OVER HERE.
NOW, A NOTICE OF THIS MEETING
WAS PUBLISHED IN THE FEDERAL
REGISTER.
COUNCIL MEMBERS MUST ABSENT
THEMSELVES IF THEIR PRESENCE
WOULD APPEAR TO CONSTITUTE A
CONFLICT OF INTEREST.
COUNCIL MEMBERS MAY NOT ENGAGE
IN ANY LOBBYING ACTIVITIES WHILE
ATTENDING COUNCIL MEMBERS OR
SPONSORED EVENT.
I'D LIKE TO REMIND YOU OF
UPCOMING CONFLICT REPORTING
DATES REQUESTED IN OCTOBER,
FEBRUARY AND JUNE AND RECEIVE
THIS REQUEST WE ASK YOU RESPOND
WITHIN 30 DAYS TO PARTICIPATE IN
COUNCIL-RELATED ACTIVITIES.
FUTURE INFORMATION ARE IN THE
ELECTRONIC COUNCIL BOOK OUR CAN
E-MAIL ME.
COUNCIL MEMBERS ONLINE, MAKE
SURE YOU'RE UNMUTED IF YOU WANT
TO SAY SOMETHING THE MINUTES FOR
POSTED IN THE ELECTRONIC BOOK.
DOES ANYONE HAVE COMMENTS OR
CORRECTION TO THESE MINUTES?
HEARING NONE I'M GOING TO MORE
TO APPROVE THE JUNE 6 COUNCIL
MINUTES.
DO I HAVE SOMEBODY SECOND THE
MOTION?
THANK YOU VERY MUCH.
ANYONE OPPOSED TO THIS MOTION,
PLEASE RAISE YOUR HAND OR SAY
NAY.
AGAIN, HEARING AND SEEING NONE
THE MOTION PASSES WITH NO
OBJECTIONS.
THANK YOU VERY MUCH.
THE MINUTES ARE APPROVED.
I'D LIKE TO REMIND YOU OF THE
DATES OF FUTURE COUNCIL MEETINGS
POSTED ON OUR PUBLIC WEBSITE AND
IN THE ELECTRONIC COUNCIL BOOK.
THE NEXT MEETING IS JANUARY 30.
THIS IS VIRTUAL SO NO ONE HAS TO
TRAVEL DURING THE WINTER.
DURING THE WINTER WE PLAN
VIRTUAL ONLY.
WE APPRECIATE YOUR PARTICIPATION
SO MAKE SURE THESE DATES I'M
GROWING TO READ OFF ARE ON YOUR
CALENDAR.
JANUARY 30, MAY 29, 2024 WILL BE
IN PERSON, OUR IN PERSON MEETING
AND AUGUST 27, 2024 WILL BE
HYBRID OR VIRTUAL WE'LL SEE HOW
THIS MEETING GOES MAKING THAT
DECISION.
AGAIN, ALL OF THIS IS POSTED OB
OUR WEBSITE.
ANY QUESTIONS ABOUT THAT BEFORE
WE MOVE ON?
NO?
THANK YOU VERY MUCH.
I'LL TURN IT BACK TO
DR. CRISWELL.
>>THANK YOU, DARREN.
THIS IS SUPPOSED TO BE THE LAST
MEETING FOR MARY BOUXSEIN AND
LEIGH CALLAHAN AND LUIS GARZA
AND SUZANNE SCHRANDT.
WE'RE DELIGHTED THEY'VE DECIDED
TO EXTEND THEIR TERMS THROUGH
MARCH OF 2024.
I APPRECIATE THEIR WILLINGNESS
TO SUPPORT US AND WE'LL SEND
THEM CERTIFICATES ACKNOWLEDGING
SERVICE.
THANK YOU FOR THEIR CONTINUING
SUPPORT.
>>I'D LIKE TO ASK FOLKS TO TURN
OFF THEIR VIDEO SO WE HAVE JUST
THE SPEAKER VIEW.
THANK YOU.
>>DR. CRISWELL: I'LL INTRODUCE
TWO NEW MEMBERS.
DR. ED BOTCHWEY THIS IS THE
FIRST MEETING OF HIS FOUR-YEAR
TERM AND A PROFESSOR IN THE
WALLACE H. COULTER DEPARTMENT OF
BIOENGINEERING OF GEORGIA
UNIVERSITY AND FOCUSES ON A
MULTI-DISCIPLINARY APPROACH TO
IMPROVE TISSUE ENGINEERING
THERAPIES BY STUDYING
INFLAMMATION RESOLUTION AND HOW
STEM CELLS WITH THE GOAL OF
DEVELOPING THERAPIES TO REPAIR,
REPLACE, PRESERVE OR ENHANCE
TISSUE OR ORGAN FUNCTION.
WELCOME, DR. BOTCHWEY.
AS WE DID WITH OUR JUNE MEETING
WE INVITED OUTSTANDING
INVESTIGATORS FROM OUR NIAMS
POOL OF MENTORED KO1, K08 AND
K23 AWARD RECIPIENT TO
PARTICIPATE AS AD HOC MEMBERS.
THE IDEA IS TO EXPOSE THEM TO
COUNCIL AND ALLOW US TO OBTAIN
INPUT FROM SCIENTISTS.
TODAY WE'RE JOINED BY
DR. JEFFERIES FROM THE OKLAHOMA
MEDICAL RESEARCH FOUNDATION AND
DR. NAYAK OF UCSF.
DR. JEFFERIES FOCUSES ON
NON-GENETIC FACTORS SUCH AS THE
INFLUENCE OF THE MICROBIOME IN
OSTEOARTHRITIS.
DR. NAYAK AN ASSISTANT PROFESSOR
OF MEDICINE IS STUDYING HOW
MICROBES INFLUENCE HEALTH AND
FOCUSSING ON THE ROLE OF THE GUT
MICROBIOME IN THE TREATMENT OF
ARTHRITIS.
A WARM WELCOME TO BOTH OF YOU.
FEEL FREE TO PARTICIPATE TODAY
AND PROVIDE YOUR VALUABLE
PERSPECTIVES.
MY REPORT TODAY WILL FOCUS ON
THREE TOPICS.
FIRST, PERSONNEL CHANGES ACROSS
THE NIH AND AT NIAMS.
THEN THE BUDGET AND OUR PLANS
FOR FISCAL YEAR 2024 AND NIH AND
NIAMS ACTIVITIES WHICH MAY BE OF
INTEREST TO YOU.
STARTING WITH PERSONNEL CHANGES.
AFTER A NATIONWIDE SEARCH, NIH
ACTING DIRECTOR, DR. LARRY TABAK
NAMES DR. JEANNE MARRAZZO THE
DIRECTOR OF NATIONAL INSTITUTE
OF ALLERGY AND INFECTIOUS
DISEASES AND CAME FROM
UNIVERSITY OF ALABAMA-BIRMINGHAM
AND LOOKS AT HORMONAL
CONTRACEPTION AND PREVENTION
USING PROPHYLACTICS AND THE
MANAGEMENT OF BACTERIAL
VAGINOSIS AND MANAGEMENT OF
ANTIBIOTIC RESISTANCE IN
GONORRHEA.
HE'S A FELLOW OF THE INFECTIOUS
DISEASES SOCIETY OF AMERICA AND
BOARD CERTIFIED IN INFECTIOUS
DISEASE.
SHE GOT HER MEDICAL INDUSTRIAL
FROM THOMAS JEFFERSON UNIVERSITY
AND HEALTH IN EPIDEMIOLOGY FROM
THE UNIVERSITY OF WASHINGTON.
SHE'S EXPECTED TO BEGIN HER ROLE
AS NIAD DIRECTOR THIS FALL.
NIH ALSO WELCOMES DR. JANE
SIMONI AS THE ASSOCIATE DIRECTOR
FOR BEHALVE AND SOCIAL SCIENCES
RESEARCH AND DIRECTOR OF THE NIH
OFFICE OF BEHAVIORAL AND SOCIAL
SCIENCE RESEARCH ALSO KNOWN AS
OBSSR.
DR. SIMONI BRINGS OVER 25 YEARS
OF EXPERIENCE IN RESEARCH
FOCUSSED ON HEALTH DISPARITIES
AND RESILIENCE AMONG POPULATIONS
THAT HAVE BEEN SOCIALLY
MARGINALIZED INCLUDING PERSONS
WITH HIV AND OTHER CHRONIC
ILLNESSES, THE LATINX
COMMUNITIES AND INDIGENOUS
PEOPLE AND JOINED FROM
UNIVERSITY OF WASHINGTON,
SEATTLE IN THE DEPARTMENT OF
PSYCHOLOGY.
SHE ALSO WAS THE FOUNDING
DIRECTOR OF THE UNIVERSITY OF
WASHINGTON BEHAVIORAL RESEARCH
CENTER FOR HIV AND CO-DIRECTED
THE UNIVERSITY OF WASHINGTON
FRED HUTCH CENTER FOR AIDS
RESEARCH.
SHE EARNED HER BACHELOR'S OF
ARTS DEGREE AT PRINCETON AND
Ph.D. AT THE UNIVERSITY OF
CALIFORNIA IN LOS ANGELES.
SHE ALSO COMPLETED POST-DOCTORAL
FELLOWSHIPS AT THE UNIVERSITY OF
SOUTHERN CALIFORNIA AND COLUMBIA
UNIVERSITY.
WITHIN NIAMS WE WELCOME SEVERAL
COLLEAGUES AND BID FAREWELL TO A
FEW OTHERS.
FIRST, MANY OF YOU ON COUNCIL
HAVE GOTTEN TO KNOW MR. NEIL
ROBERTS, OUR OPERATIONS ANALYST
IN THE DIVISION OF EXTRAMURAL
ACTIVITIES THROUGH HIS WORK ON
COUNCILS INCLUDE TODAY AND HE'LL
BE MOVING TO NHLBI AS A
COMMITTEE MANAGEMENT SPECIALIST
SO THIS WILL BE NEIL'S LAST
COUNCIL MEETING AT NIAMS.
WE'RE GRATEFUL AT HIS SUPPORT
AND WISH HIM THE BEST IN HIS NEW
ROLE.
EVERY OTHER YEAR YOU HEAR FROM
OUR CLINICAL RESEARCH OPERATIONS
AND MANAGEMENT BRANCH ABOUT THE
DIVERSITY OF PARTICIPANTS AND
NIAMS FUNDED CLINICAL TRIALS.
THOSE WHO SERVE ON THE CLINICAL
TRIALS WORKING GROUP ALSO
INTERACT WITH THE BRANCH SO I
WANTED TO ANNOUNCE A FEW
PERSONNEL CHANGES THERE.
WITH THE DEPARTURE OF KHAN AND
NICOLE NAYAK WE'RE RECRUITING A
NEW BRANCH CHIEF WE HOPE TO HAVE
IN OCTOBER.
WITH THE RETIREMENT OF PROGRAM
DIRECTOR HANG SANG OF OUR SKIN
BIOLOGY TEAM THE INSTITUTE HIRED
DR. KOCH AT THE BRODY SCHOOL OF
MEDICINE AT EAST CAROLINA
UNIVERSITY AS OUR NEWEST PROGRAM
DIRECTOR.
DR. KOCH RECEIVED HIS Ph.D. IN
GERMANY STUDYING GLYCOPROTEINS.
HE'LL BE OVERSEEING THE NIAMS
SKIN RESEARCH PORTFOLIO ALONG
WITH OUR PROGRAM DIRECTORS,
DOCTORS SABATI AND ALEXI
BELLKIN.
MANY HAVE VIRTUALLY MET WITH MS.
WELLINGTON IN THE DIVISION OF
EXTRAMURAL ACTIVITIES.
SHE'S HERE WITH US TODAY AND SHE
EARNED HER BACHELOR OF SCIENCES
FROM MORGAN STATE UNIVERSITY IN
HEALTH EDUCATION AND MASTER OF
SCIENCE FROM THE UNIVERSITY OF
MARYLAND GLOBAL COLLEGE HEALTH
INFORMATICS MANAGEMENT AND WORK
WITH DARREN ON COUNCIL
ACTIVITIES.
WE ALSO WELCOME TWO PROGRAM
ANALYSTS, MS. SINGH JOINED US
FROM THE EUNICE KENNEDY SHRIDER
FROM THE LAB DEVELOPMENT AND
MR. DAVIS WAS A PROGRAM ANALYST
IN THE NIAID EXTRAMURAL PROGRAM
AND HE'LL BRING TO NIAMS HIS
EXPERTISE IN PORTFOLIO ANALYSIS
AND SUPPORTING THE INSTITUTE'S
TRAINING PROGRAM.
AS I ANNOUNCED AT THE LAST
MEETING, NIAMS ISSING FOR A NEW
SCIENTIFIC DIRECTOR OF OUR
EXTRAMURAL RESEARCH PROGRAM
FOLLOWING DR. O'SHAY'S
ANNOUNCEMENT HE'LL BE STEPPING
DOWN AND I'M DELIGHTED HE'S WITH
US HERE TODAY.
SO HE'S DELIGHTED TOO, HE SAYS.
WE'RE CONDUCTING A NATIONWIDE
SEARCH AND HOPE YOU'LL HELP US
BY TELLING COLLEAGUES WHO MAY BE
QUALIFIED AND INTEREST ABOUT
THIS AMAZING OPPORTUNITY.
THE ANNOUNCEMENT WILL BE
PUBLISHED WIDELY ON MANY
SCIENTIFIC JOURNALS AS WELL AS
THE NIH WEBSITE OPENED
YESTERDAY.
THIS IS HOT OFF THE PRESS.
YOU CAN SEE THE LINK TO THE
ANNOUNCEMENT THERE AT THE TO THE
SLIDE.
REVIEW OF APPLICATIONS WILL
BEGIN OCTOBER 30, 2023 AND
APPLICATIONS WILL CONTINUE TO BE
ACCEPT AND CONSIDERED UNTIL THE
POSITION IS FILLED WHICH WE HOPE
WILL BE NEXT SUMMER.
SO MOVING ON TO BUDGET UPDATES.
WHEN WE LAST MEETING IN JUNE, I
OUTLINED THE PRESIDENT'S
PROPOSED BUDGET FOR THE NIH AND
NIAMS FOR FISCAL YEAR 2024 WHICH
WOULD BEGIN OCTOBER 1.
SINCE THEN THE HOUSE AND SENATE
HAVE RELEASED THEIR OWN BUDGET
PROPOSALS.
IN ATIME WHEN MANY AGENCIES ARE
FACING THE PROSPECT OF BUDGET
CUTS WE'RE GRATEFUL TO THE
AMERICAN PUBLIC AND OFFICIALS
FOR KEEPING THE NATIONAL
ARTHRITIS AND MUSCULOSKELETAL
AND SKIN DISEASES AS A PRIORITY.
AS THE NEXT STEP THE HOUSE AND
SENATE MUST CONVENE A CONFERENCE
COMMITTEE TO AGREE ON NUMBERS
NOT JUST FOR NIH BUT FOR THE
ENTIRE DEPARTMENT OF HEALTH AND
HUMAN SERVICES AS WELL AS THE
DEPARTMENTS OF LABOR AND
EDUCATION.
THEN THAT VERSION OF THE BILL
MUST PASS BOTH CHAMBERS BEFORE
GOING TO THE PRESIDENT FOR
SIGNATURE.
THIS MAY NOT OCCUR BEFORE THE
CURRENT FISCAL YEAR SEPTEMBER 30
SO WE WON'T BE SURPRISED IF WE
BEGIN THE FISCAL YEAR ON A
CONTINUING RESOLUTION.
THIS WOULD MEAN WE COULD
CONTINUE TO OPERATE AT OR
SLIGHTLY BELOW OUR FISCAL YEAR
2023 LEVEL BUT WILL IMPACT OUR
ABILITY TO SET PAY LINES FOR THE
NEW YEAR.
AS WE DISCUSSED AT OUR JUNE
MEETING, FOR THE CURRENT FISCAL
YEAR, NIAMS IS COMMITTED TO
FUNDING RO1 APPLICATION FOR MOST
INVESTIGATORS THROUGH THE 10
PERCENTILE AND HIGHER PAY LINE
FOR RESEARCHERS WHO MEET THE
NIH'S CRITERIA FOR EARLY STAGE
INVESTIGATORS.
THIS SLIDE SHOWS THE FUNDING
PLAN WITH THE PRIORITY SCORES
FOR OTHER PROGRAMS AS WELL.
THOUGH THE CURRENT PAY LINE OF
THE 10 PERCENTILE WAS SLIGHTLY
LOWER THAN IN PREVIOUS YEARS AT
THE SAME TIME, WE'VE EXPANDED
WHAT WE HISTORICALLY HAVE CALLED
SELECT PAY.
AS DESCRIBED ON OUR WEBSITE,
THIS REFERS TO FUNDS AVAILABLE
FOR AWARDS TO APPLICATIONS THAT
PROGRAM DIRECTORS IDENTIFY AS
BEING OF THE HIGHEST PRIORITY
EVEN THOUGH THEY SCORED BEYOND
THE PUBLISHED PAY LINE.
IMPORTANTLY, THIS MEANS THAT WE
WON'T BE FUNDING FEWER RO1
GRANTS THIS YEAR BUT INSTEAD
REFLECTS EFFORTS OF PROGRAM
DIRECTORS TO LOOK AT
APPLICATIONS ABOVE THE PAY LINE
TO RECOMMEND THOSE FOR FUNDING.
WE HAD MANY INTERNAL DISCUSSIONS
AND REFLECTED ON COMMENTS YOU
FROM AND COMMUNITY MEMBERS AND
DISCUSSIONS WITH LEADERSHIP
ABOUT THE IMPORTANT TOPIC AND
YOU HEARD FROM DR. BURNS AT OUR
LAST MEETING AND LOOKING TO
INCREASE THE POOL AVAILABLE IN
FISCAL YEAR 2024 AND WILL BE
COMING WITH ADDITIONAL CHANGES
TO OUR POLICIES THAT COULD
PROVIDE MORE PAY SELECT SUPPORT
IN FUTURE YEARS.
AND WE'RE LOOKING AT A
CONSERVATIVE PAY LINE THROUGH
WHICH APPLICATIONS WILL BE
FUNDED WITH RARE EXCEPTIONS.
THEN THERE WOULD BE A MIDDLE
RANGE OF SCORES THROUGH WHICH AN
APPLICATION MIGHT BE FUNDED
EITHER BASED ON THE PERCENTILE
OR PROGRAMMATIC CONSIDERATIONS.
AND BE THE A BROADER OUT RANGE
OF SCORES WHERE APPLICATIONS ARE
HIGHLY UNLIKELY TO BE FUNDED.
SO I LOOK FORWARD TO ADDITIONAL
DISCUSSION ABOUT THIS TOPIC
MOVING FORWARD.
I NOW WANT TO SHARE AN
INITIATIVE I'M EXCITED ABOUT.
AS WE LOOK TO BRING PEOPLE IN
THE NIAMS FOLD WE'RE SEEKING TO
ENSURE A CIVIL WORKPLACE
ENVIRONMENT WHERE WE EMPHASIZE
WORKING TOWARDS A COMMON GOAL
WITH INTERITY, ACCOUNTABILITY
AND RESPECT FOR DIVERSITY OF
EXPERIENCES AND PERSPECTIVES.
TO THIS END, THE NIAMS CULTURE
COMMITTEE HAS BEEN WORKING WITH
STAFF AND LEADERSHIP TO UPDATE
THE INSTITUTE'S INTERNAL CORE
VALUES WHICH WERE DEVELOPED WITH
BROAD INPUT FROM NIAMS STAFF AND
ROLLED OUT THIS MONTH.
THE NIAMS CORE VALUES UNDER
SCORE NIAMS COMMITMENT TO
CULTIVATING A WORKPLACE THAT IS
RESPECTFUL AND INCLUSIVE.
THIS ENVIRONMENT WILL INSPIRE
AND SUPPORT US AS WE ADVANCE
RESEARCH TO IMPROVE THE HEALTH
OF PEOPLE IN THE UNITED STATES.
WE HOPE WE AGREE AS WE PROMOTE A
CULTURE OF EXCELLENCE AT ALL
LEVELS OF THE INSTITUTE.
MY THANKS AGAIN TO THOSE WHO
WORKED ON THIS.
IN FOLLOWING UP TO THE
PRESENTATION ON THE NIAMS
STRATEGIC PLANNING PROCESS I'M
GRATEFUL TO THOSE VOLUNTEERING
THEIR TIME TO ATTEND THE
UPCOMING THREE-DAY MEETING OR
WHO MADE THE EXTRA EFFORT TO
FIND A COLLEAGUE TO PARTICIPATE
IN YOUR PLACE, RESEARCHERS AND
STAFF FROM OTHER INSTITUTES AND
CENTERS AND OFFICES FROM ACROSS
THE NIH AND PATIENT
REPRESENTATIVES AGREED TO JOIN
US ON CROSS-CUTTING TOPICS THE
INSTITUTE SHOULD PURSUE THROUGH
THE END OF THE DECADE.
NIAMS' STRATEGIC PLANS ARE A
PUBLIC STATEMENT OF THE
INSTITUTE'S INTERESTS, A GUIDE
POST FOR THE SCIENTIFIC
COMMUNITY AND AN INTERNAL
REFERENCE DOCUMENT.
THEREFORE WE'RE MAKING A
CONCERTED EFFORT TO CANVAS ALL
INTERESTED BY PROVIDING THEM
WITH OPPORTUNITIES TO RESPOND IN
WRITING BY PARTICIPATING IN THIS
INVITATION ONLY VIRTUAL MEETING
OR REQUEST FOR INFORMATIONS SUCH
AS THE ONE WE ISSUED LAST FALL.
AFTER THIS IDEA GENERATION
MEETING WE'LL GET AN RFI TO GET
FURTHER INPUT ON A SUBSET OF
TOP
TOPICS IDENTIFIED BY
PARTICIPANTS SO EVERYONE CAN
HAVE THEIR VOICES HEARD.
WE HOPE YOU'LL SPREAD THE WORD
ABOUT THE RFI WHEN IT'S
PUBLISHED.
SOME OF YOU MAY RECALL THE
PRESENTATION AT THE SEPTEMBER
2022 ADVISORY COUNCIL MEETING
AND WERE TOLD ABOUT THE NIAMS
COALITION OUTREACH AND EDUCATION
MEETING THAT IS PLANNED FOR THIS
FALL.
SPECIFICALLY, THIS MEETING WILL
OCCUR TUESDAY SEPTEMBER 19 HERE
ON THE NIH CAMPUS.
THIS NIAMS-HOSTED HALLMARK EVENT
IS HELD EVERY OTHER YEAR WITH
THIS THE FIRST IN-PERSON MEETING
SINCE THE PANDEMIC AND THIS IS A
CHANCE TO LEARN FROM ONE
ANOTHER, INSPIRE COLLABORATIONS
AND ADVANCE OUR SHARED GOALS
REGARDING ARTHRITIS,
MUSCULOSKELETAL SKIN DISEASES
FOR MEDICAL PROFESSIONALS.
WE HAVE A FANTASTIC LINE UP.
WHILE THE NIH LEADERSHIP WILL
HAVE REMARKS FROM DR. TABAK AND
THE UPDATE AND KEY NOTE
PRESENTATIONS FROM CEO OF THE
FOUNDATION FOR THE NIH AND THE
DIRECTOR OF ARPA-H.
SO FOR THOSE INTERESTED IN OUR
INTERACTION WITH PATIENT AND
PROFESSIONAL ORGANIZATION
COMPRISE THE COALITION, VIEW THE
BROADCAST PORTION FROM 9:00 A.M.
TO 2:15 P.M. EASTERN TIME VIA
THE NIH VIDEOCAST WEBSITE ON
SEPTEMBER 19.
ALSO COMING SOON, ARE EARLY
RESEARCH RESULTS FROM THE
MOLECULAR TRANSDUCERS OF
PHYSICAL ACTIVITY CONSORTIUM.
IT'S A COMMON FUND PROGRAM WITH
NIAMS AND THE NATIONAL INSTITUTE
OF AGING, THE NATIONAL INSTITUTE
OF DIABETES AND DIGESTIVE
DISEASES, NIDDK.
IT'S A NATIONAL RESEARCH
CONSORTIUM FIRST FUNDED IN 2017
TO DISCOVER AND PRELIMINARILY
CHARACTERIZE THE MOLECULAR
TRANSDUCER THAT UNDER LIE THE
EFFECT OF PHYSICAL ACTIVITY IN
HUMANS AND RATS OF VARIOUS AGES.
THE GOAL IS TO STUDY THE
MOLECULAR CHANGES THAT OCCUR
DURING AND AFTER EXERCISE AND
ULTIMATELY TO ADVANCE THE
UNDERSTANDING OF HOW PHYSICAL
ACTIVITY IMPROVES AND PRESERVES
HEALTH.
RESULTS FROM PROFILING OF THE
TEMPORAL TRANSCRIPTOME IS THE
IMM
IMMUNEOME HAVE PRE PRINTS
VALUABLE NOW.
THE PAPER DETAILS 25 MOLECULAR
PLATFORMS AND FOUR TRAINING TIME
POINTS IN MALE AND FEMALE RATS.
MY INSTITUTE DIRECTOR COLLEAGUES
AND I LEADING THE PROGRAM ALSO
WROTE A COMMENTARY WHICH WILL BE
PUBLISHED WHEN THE PAPER IS
FORMALLY RELEASED.
LATER NEXT YEAR, I INTEND TO
INVITE AN INVESTIGATOR TO
PRESENT FINDINGS AT A COUNCIL
MEETING.
I UNDERSTAND IT'S BEEN MANY
YEARS SINCE YOU HEARD A
PRESENTATION ON MOTRPC.
I'LL NOW PROVIDE A FEW QUICK
UPDATES.
THANKS TO A GENEROUS INCREASE,
NIAMS WAS ABLE TO PUBLISH
NOTICED SPECIAL INTEREST ON PAIN
RESEARCH IN RHEUMATIC, SKIN AND
MUSCULOSKELETAL DISEASES.
THE FIRST IS FOR PEOPLE WHO HAVE
AGE ACTIVE NIAMS GRANT AND WOULD
LIKE TO ADD OR EXPAND RESEARCH
ON PAIN AS IT REL RELATES TO THE
TOPIC AND WOULD LIKE TO SUPPORT
OUR T32 TRAINING PROGRAMS TO
FOCUS ON THE MECHANISMS,
MEASUREMENT OR TREATMENT OF PAIN
AS IT RELATES TO TREATMENT
AREAS.
APPLICATIONS WERE DUE IN JUNE
AND EXPECT TO MAKE AWARDS SOON.
UNDERSTANDING PAIN REMAINS A
PRIORITY.
ON THE TOPIC OF PAIN RESEARCH,
THE NIH HEAL INITIATIVE THE
HELPING TO END ADDICTION LONG
TERM IS AN EFFORT TO STEM THE
NATIONAL OPIOID PUBLIC HEALTH
CRISIS.
ALMOST EVERY INSTITUTE AND
CENTER IS ACCELERATING RESEARCH
TO ADDRESS THIS FROM ALL ANGLES.
AMONG THOSE EFFORTS, NIAMS IS
LEADING THE BACK PAIN CONSORTIUM
PROGRAM WHICH IS A TRANSLATIONAL
PATIENT-CENTERED COLLABORATION
TO ADDRESS THE NEED FOR
EFFECTIVE AND PERSONALIZED
THERAPIES FOR CHRONIC LOW BACK
PAIN.
NIAMS IS ALSO LEADING THE
RESTORING JOINT FUNCTION TO
REDUCE PAIN OR REJOIN CONSORTIUM
WITH RESEARCH TEAMS WORKING
TOGETHER TO MAP THE NETWORK OF
SENSORY NERVE S THAT CONNECT TO
THE TEMPORO MANDIBULAR JOINT AND
KNEE AND HOW THE PATTERNS OF
SENSORY NETWORKS CHANGE WITH
AGING AND THE NCCIH ALSO LEADS
AN EFFORT TO AIM TO DEVELOP
QUANTITATIVE IMAGING AND
BIOMARKERS OF MAYO FASCIAL
TISSUES FOR CLINICAL PAIN
MANAGEMENT AND NINDS AIMS TO USE
PRIMARY HUMAN TISSUES IN CELLS
TO BUILD COMPREHENSIVE DATA SETS
OF MOLECULAR SIGNATURES, CELL
TYPES AND CELLULAR FUNCTION
PHENOTYPES OR SIGNATURES THAT
UNDER LIE HUMAN PAIN
TRANSDUCTION AND TRANSMISSION
AND PROCESSING.
SO A CRITICAL PART OF HEAL IS
COLLECTING DATA THAT CAN BE
INTEGRATED ACROSS MODELS AND
ACROSS DOMAINS TO BETTER
UNDERSTAND CHRONIC PAIN.
AS ILLUSTRATED, WE'RE STARTING
TO CREATES AN ECO SYSTEM TO
ADDRESS THE DOMAINS ESSENTIAL TO
UNDERSTAND AND TREAT PAIN FROM
THE ENVIRONMENT AND PSYCHOSOCIAL
FACTORS TO COMPLEX MOLECULAR
INTERACTIONS.
WITH COLLABORATIVE EFFORTS WITH
HEAL PROGRAMS WE CAN MAKE
SIGNIFICANT ADVANCES AGAINST THE
CHRONIC PAIN THAT PLAGUES
PATIENTS AND SOCIETY.
DR. LESTER OF EXTRAMURAL
RESEARCH WILL MENTION A CONCEPT
CLEARANCE LATER TODAY RELATED TO
THE NEXT STEPS FOR HEAL.
RELATED TO HEAL I'LL PROVIDE AN
UPDATE ON THE HEAL KIDS I
MENTIONED IN JUNE.
NICHD ISSUED TWO NOTICES.
ONE IS FOR A PAIN RESOURCE AND
DATA CENTER AND THE OTHER IS FOR
SUPPORTING AN ACUTE PAIN
CLINICAL TRIALS PROGRAM.
NIAMS HAS SIGNED ON TO BOTH AND
THESE WILL EXPIRE IN NOVEMBER.
WITHIN THE NIAMS MISSION THIS
COULD RELATE TO ACUTE ORTHOPEDIC
PAIN FROM COMMON INJURIES OR
ACUTE PAIN CAUSED BY DISEASE
FLARES IN CHILDREN WITH CHRONIC
CONDITION WIN OUR MISSION.
THIS SLIDE HIGHLIGHTS A
PARTNERSHIP IS BETWEEN ORWH AND
NIAMS.
AS YOU MAY RECALL, DR. CLAYTON
THE ORWH DIRECTOR AND I
ANNOUNCED THIS NEW OPPORTUNITY A
YEAR AGO AT THE SEPTEMBER NIAMS
ADVISORY COUNCIL MEETING.
I'M PLEASED TO PROVIDE A QUICK
UPDATE AND YOU'LL HEAR MORE FROM
DR. CLAYTON AS WELL AS COMMENTS
FROM DR. JUDITH JAMES THE
EXECUTIVE VICE PRESIDENT AND
CHIEF MEDICAL OFFICER OF THE
OKLAHOMA MEDICAL RESEARCH
FOUNDATION AND PROFESSOR AND
PROGRAM CHAIR OF ITS ARTHRITIS
AND IMMUNOLOGY RESEARCH PROGRAM
TO HAVERS DEDICATED TO WOMEN'S
HEALTH RESEARCH BY TRAINING IN
LEADERSHIP AND MENTORING USING
THE INFRASTRUCTURE OF THE
AMP/AIM PROGRAM.
I'M THRILLED TO REPORT AWARDEES
WILL BE ANNOUNCED VERY SOON AND
THAT THE UPCOMING ANNOUNCEMENT
OF THE FIRST CLASS OF SCHOLARS
IS ONLY THE FIRST PHASE OF OUR
ONGOING EFFORT.
GIVEN THE ROBUST RESPONSE TO OUR
PILOT, NIH WILL BE ISSUING A
SECOND FUNDING OPPORTUNITY
ANNOUNCEMENT FOR THE PROGRAM
LATER THIS FALL SO PLEASE STAY
TUNED FOR MORE INFORMATION ABOUT
THIS IN THE COMING MONTHS.
AS I MENTIONED IN OUR LAST
COUNCIL MEETING, NIAMS IS
PARTICIPATING WITH ORWH AND THE
NATIONAL INSTITUTE OF
ENVIRONMENTAL HEALTH SCIENCES
AND OTHER INSTITUTES AND CENTERS
ON A RECENTLY PUBLISHED NOTICE
ON THE EXPOSOME AND AUTOIMMUNE
DISEASES CALLED EXPOSOME AND
AUTOIMMUNE DISEASE PLANNING
AWARDS OR EXACT PLAN.
THE GOAL IS TO INVITE
APPLICATION FOR EXPLORATORY
EARLY AND CONCEPTUAL PROJECTS
AIMED AT DEVELOPING A FUTURE
TEAMS SCIENCE NETWORK.
I WANTED TO INTRODUCE THIS TOPIC
AS YOU'LL HEAR MORE FROM OUR
SPEAKERS TODAY.
NIAMS WORKS WITH OTHER
ORGANIZATIONS IN A VARIETY OF
WAYS AND WOULD LIKE TO REMIND
YOU OF THE ALL OF US RESEARCH
PROGRAM.
ALL OF US IS AN AMBITIOUS EFFORT
TO GATHER HEALTH DATA FROM ONE
MILLION PEOPLE OR MORE IN THE
UNITED STATES TO ACCEL RESEARCH
THAT MAY IMPROVE HEALTH AND HAS
ENROLL OVER 684,000
PARTICIPANTS.
OVER 471,000 OF THESE
PARTICIPANTS HAVE COMPLETED THE
INITIAL STEPS OF THE PROGRAM
WHICH INCLUDES CONSENTING,
AGREEING TO SHARE ELECTRONIC
HEALTH RECORDS, COMPLETING THE
FIRST THREE SURVEYS, PROVIDING
PHYSICAL MEASUREMENTS AND
DONATING AT LEAST ONE BIO
SPECIMEN TO BE STORED AT THE BIO
BANK.
OVER 80% OF PARTICIPANTS COME
FROM GROUPS UNDER REPRESENTED IN
BIOMEDICAL RESEARCH, A MAJOR
GOAL OF THIS PROGRAM.
THE PROGRAM CURRENTLY COLLECTS A
WIDE RANGE OF DATA FROM
ELECTRONIC HEALTH RECORDS TO
SURVEYS, BIO SAMPLES AND
WEARABLE DATA FROM FITBIT AND
OTHER DEVICES.
"ALL OF US" IS INTERESTED IN
INTEGRATING INDIVIDUAL LOCATION
AND ENVIRONMENTAL EXPOSURE DATA
INTO ITS DATA SET.
SO IN COLLABORATION WITH NIEHS
IT'S LOOKING TO UNDERSTAND THE
INTERACTIONS BETWEEN THE
EXPOSOME AND THE RESEARCHER WORK
BENCH TO ACCESS THE DATA
COLLECTED FROM PARTICIPANTS.
YOU'LL HEAR MORE ABOUT THIS
IMPORTANT EFFORT LATER TODAY
FROM DR. WOYCHIK THE NIEHS
DIRECTOR.
BEFORE I OPEN THE MEETING FOR
DISCUSSION, I'D LIKE TO DRAW
YOUR ATTENTION TO A REQUEST FOR
INFORMATION THAT NIH JUST
PUBLISHED LAST FRIDAY.
IN RESPONSE TO RECOMMENDATIONS
FROM THE NIH ADVISORY COMMITTEE
TO THE DIRECTOR WORKING GROUP ON
DIVERSITY, NIH HAS DEVELOPED A
PROPOSED REVISED MISSION
STATEMENT AND SEEKING INPUT FROM
INTEREST GROUPS THROUGHOUT THE
SCIENTIFIC RESEARCH, ADVOCACY
AND CLINICAL PRACTICE
COMMUNITIES, THOSE EMPLOYED BY
NIH OR INSTITUTIONS RECEIVING
NIH SUPPORT AND THE PUBLIC ON
THE PROPOSED STATEMENT.
ADDITIONAL INFORMATION AND HOW
TO PROVIDE INPUT IS AVAILABLE ON
THE NIH WEBSITE.
I ENCOURAGE ALL OF YOU TO REVIEW
THE PROPOSAL AND SHARE IT WITH
YOUR COMMUNITIES AND CONSIDER
PROVIDING YOUR INPUT.
THIS CONCLUDES MY REPORT AND I
WELCOME YOUR COMMENTS OR
QUESTIONS NOW OR IN TIMES SET
ASIDE IN THE OPEN OR CLOSED
SESSION TO RAISE ISSUES ON YOUR
MIND SO THANK YOU VERY MUCH.
IS
>>WE WILL ASK THE COUNCIL TURN
ON YOUR CAMERAS.
>>DR. CRISWELL: WE HAVE PLENTY
OF TIME AND HAVE A TIGHT
SCHEDULE FOR THE REST OF THE
MORNING.
WE'RE PREPARED TO MOVE AHEAD
MORE QUICKLY THAN AS SHOWN ON
THE AGENDA.
IF THAT MAKES SENSE GIVEN THE
DISCUSSION.
I SEE ANOTHER ONE OF OUR COUNCIL
MEMBERS HAS JUST JOINED US.
MAYBE SHE CAN INTRODUCE HERSELF.
>>DR. YAZDANY: I'M A CLINICAL
RESEARCHER CHIEF OF DIVISION OF
RHEUMATOLOGY ZUCKERBERG FOR
INSTANCE GENERAL HOSPITAL.
>>DR. CRISWELL: I SEE LUIS
GARZA.
>>LUIS:.
ONE QUESTION THAT MAY COME UP
AMONG THE ACADEMIC CONSTITUENCY
OF THE NIAMS IS REGARDING THE
NEW PLAN FOR ADDING MORE FREEDOM
FOR THE DECISION OF DOING THE
PROVISIONAL FUNDING FOR SCORES
THAT WEREN'T FULLY FUNDED IN THE
GRAY ZONE AND I THINK A LOT OF
RESEARCHERS ARE GOING TO ASK
WHAT ARE SOME CRITERIA.
MENTIONED PROGRAMMATIC GOALS
WOULD BE A CRITERIA AND WONDER
IF YOU CAN CLARIFY WHERE TO FIND
THE PROGRAMMATIC GOALS TO
UNDERSTAND HOW DECISIONS GET
MADE.
>>DR. CRISWELL: WE HAVE BEEN
THINKING ABOUT THE RESOURCES WE
HAVE, RETURN ON INVESTMENTS AND
HOW WE CAN MAKE THE BEST USE OF
EVERY SINGLE DOLLAR.
WE'RE ANTICIPATING UNFORTUNATELY
THE NEXT FEW YEARS OUR BUDGETS
MAY NOT BE INCREASING THE WAY
THEY HAVE THE LAST FEW YEARS.
I WANT TO START BY EMPHASIZING
SOMETHING WE HEARD FROM
LEADERSHIP THE SCIENTIFIC REVIEW
PROCESS THAT OCCURS AT THE
CENTER FOR SCIENTIFIC REVIEW AND
WITHIN THE STUDY SECTIONS THAT
SUPPORT THE INSTITUTES, PROVIDE
AN INCREDIBLY IMPORTANT SERVICE
IN THE EVALUATING THE SCIENTIFIC
MERIT OF APPLICATIONS.
IT'S NOT A PERFECT PROCESS BUT
MAY BE THE BEST WE HAVE AROUND
THE WORLD.
IT'S SOMETHING WE HEARD FROM THE
NIH DIRECTOR AS WELL AS CSR
LEADERSHIP, WHAT THE SCORES
DON'T ACCOUNT FOR ARE PRIORITIES
AND PERSPECTIVES OF THE
INSTITUTES.
IN FACT THE STUDY SECTION SO
IT'S NOT POSSIBLE TO ALIGN THE
INSTITUTES WITH THE STUDY
SECTIONS OF THE SCORES.
WE'VE BEEN ENCOURAGED TO THINK
CAREFULLY ABOUT THE PRIORITIES
GIVEN OUR MISSION AREAS, THE
EMERGING OPPORTUNITIES IN FIELDS
OF SCIENCE THAT THAT MAY
CURRENTLY BE UNDER FUNDED AS
WELL AS OTHER CONSIDERATIONS
SUCH AS THE BIOMEDICAL WORKFORCE
AND PIPELINE AND CHALLENGES OF
EARLY STAGE INVESTIGATORS.
I FEEL COMFORTABLE IN ACCEPTING
THE NOTION WE HAVE TO CONSIDER
THE SCORE OF AS A CRITICAL
COMPONENT AND OTHER FACTORS.
BACK TO YOUR SPECIFIC QUESTION
WE ALSO UNDERSTAND COMMUNICATION
ABOUT OUR THINKING AND POLICIIE
DEVELOP OVER TIME IS SOMETHING
TO CONSIDER INTERNALLY AND
EXTERNALLY AND WHAT APPROACHES
WE'RE TAKE OVER TIME.
THE SORTS OF CONSIDERATIONS THAT
GO INTO WHAT WE'RE CALLING EARLY
STAGE INVESTIGATORS.
WE GET REGULAR REQUESTS FROM NIH
LEADERSHIP TO DO ALL WE CAN TO
SUPPORT AS MANY EARLY CAREER
INVESTIGATORS AS POSSIBLE.
ANOTHER NIH PRIORITY WE'RE
REMINDED REGULARLY ABOUT HAS TO
DO WITH AT-RISK INVESTIGATORS
WHO HAVE A MERITORIOUS GRANT WHO
WITHOUT FUNDING MAY HAVE TO
CLOSE THEIR LABS.
WE HAVE A STRATEGIC PLAN THAT
IDENTIFIED CROSS-CUTTING THEMES
WE THINK WERE MOST RELEVANT TO
SOME OF THE GOALS WE'RE TRYING
TO ACCOMPLISH AS AN INSTITUTE.
ALIGNMENT WITH THE THEMES OF OUR
STRATEGIC GOALS ARE EXAMPLES OF
PRIORITY WOULD RELEVANT
CONSIDERATIONS.
I ENVISION WE'LL LOOK TO CLOSELY
ALIGN OUR GOALS WITH OUR FUNDING
DECISIONS AND ANOTHER TOOL WE
ARE INTERESTED IN IMPLEMENTING
AND APPLYING ON A MORE
CONSISTENT BASIS IS PORTFOLIO
ANALYSIS.
I HEAR MANY COMMENTS FROM MY
COLLEAGUES WHO DIRECT OTHER
INSTITUTES ABOUT THE FACT THAT
THEY OFTEN CHOOSE NOT TO FUND
VERY WELL SCORING GRANTS BECAUSE
THEY ALREADY HAVE TOO MANY
GRANTS THEY'RE SUPPORTING IN
THAT PARTICULAR AREA.
THE EXAMPLE WAS WE DON'T NEED A
20th TRIAL OF X AND OUR DOLLARS
CAN BE BETTER SPENT ON OTHER
SUBJECTS.
PORTFOLIO ANALYSIS AS A TOOL TO
UNDERSTAND WHAT ARE WE FUND IIN
WE THINK WILL HELP IDENTIFY
THOSE AREAS FOR WHICH ADDITIONAL
FUNDING MAY BE HELPFUL.
WE'RE COMMITTED TO SHARING ON
THE WEBSITE AND IN COMMUNICATION
WITH THE COMMUNITY THE
PRIORITIES WE'RE USING FOR
SELECT PAY GOING FORWARD.
I HOPE THAT GIVES A SENSE OF
WHERE WE'RE COMING FROM AND
THINKING ABOUT.
I SEE TWO HANDS.
ED ON THE LEFT AND THEN RANUKA
ON THE RIGHT.
>>ED: ARE PROGRAM DIRECTORS
CONSIDERED IN DIRECT PAY?
I WAS UNCLEAR?
>>DR. CRISWELL: I ASSUMED I WAS
NOT SUPPOSED TO EVER REACH OUT
TIE PROGRAM OFFICER.
I HAD ALMOST NO CONVERSATIONS
AND THOUGHT THAT WAS
INAPPROPRIATE.
NOW I UNDERSTAND OUR PROGRAM
OFFICERS ARE AMAZING RESOURCES
AND HERE TO SUPPORT YOU.
AND WHEN IT COMES TO SELECT PAY,
I THINK THERE'S LANGUAGE ON THE
WEBSITE BUT SELECT PAY
NOMINATIONS COME FROM THE
PROGRAM DIRECTORS.
WE DON'T EXPECT AND IT'S NOT
CONSIDERED PART OF THE PROCESS
FOR INVESTIGATORS TO
SELF-NOMINATE.
YOU DON'T HAVE TO WORRY IF YOU
DON'T REAP OUT WILL IT NOT BE
CONSIDERED?
I SHOULD ADD AN IMPORTANT PART
OF CONSIDERING WHAT WE GET BACK
FROM CSR IS THE SUMMARY
STATEMENT AND THE DETAILED
REVIEW.
A NUMBER OF APPLICATIONS WITH
THE SAME SCORE BUT DIFFERENT
PROFILE OF REACTIONS FROM STUDY
SECTION MEMBERS.
MAY DIVERGENT VIEWS SO THE
PROGRAM DIRECTORS SPEND A LOT OF
TIME SCRUTINIZING THE SUMMARY
STATEMENT TO TRY TO UNDERSTAND
THE SCORE DRIVING
CONSIDERATIONS.
THAT'S ALSO PART OF HOW WE
CONSIDER THE SCORE.
INVESTIGATORS DO NOT NOMINATE
THEIR APPLICATIONS FOR SELECT
PAY.
THEY COME FROM PROGRAM DIRECTORS
BUT PROGRAM DIRECTORS REACH OUT
TO INVESTIGATORS IF THEY HAVE
QUESTIONS ABOUT THE APPLICATION
AND IF YOU HAVE QUESTIONS ABOUT
THE PROCESS OR ANYTHING RELATED
TO YOUR GRANT, THEY'RE A
RESOURCE FOR YOU.
>>IS THERE GOING TO BE AN
OPPORTUNITY FOR REBUTTAL?
CONSIDER THE CONSIDERATION OF
THE SELECT PAY THE P.I. HAS AN
OPPORTUNITY TO PROVIDE
ADDITIONAL INFORMATION IN A
WRITTEN FORMAT FOR SELECT PAY?
>>DR. CRISWELL: I KNOW THEY'LL
REACH OUT TO INVESTIGATORS FOR
QUESTIONS THEY THINK THE
INVESTIGATOR CAN ANSWER.
I'M NOTE FAMILIAR WITH THE
FORMAL REBUTTAL PROCESS BUT
MAYBE DARREN OR OTHERS CAN SPEAK
TO THAT.
>>THAT'S A FORMAL RESPONSE
STATEMENT THROUGH YOUR OFFICE
AND SRO THAT IS DITCH THAN WHAT
WE'RE TALKING ABOUT.
WE'RE TALKING ABOUT OPPORTUNITY
TO CLARIFY WHAT MAY HAVE BEEN
CONFUSED NOT AN ERROR IN THE
REVIEW.
I DON'T KNOW IF THAT HELPS OR
NOT.
>>I FEEL SOMETIMES THE P.I. IS
THE BEST PERSON TO ADVOCATE FOR
THEMSELVES.
MAYBE REBUTTAL IS NOT THE BEST
WORD FOR WHAT I'M THINKING OF
BUT JUST AN IDEA.
>>BOB: IF I CAN CHIME IN.
I HAVE PROGRAMS WHERE THEY
INVITE FORMAL REBUTTALS.
IN FACT ALMOST REQUIRE THEM.
I FOUND THEM USUALLY TOTALLY
UNHELPFUL.
FIRST, ANY GOOD INVESTIGATOR CAN
WRITE REBUTTAL THAT MAKES YOU
THINK THE APPLICATION'S THE BEST
THING SINCE SLICED BREAD AND
YOUR PROBABLY RIGHT BUT DOESN'T
HELP IN THE SELECTION PROCESS.
THE LONGER ANSWER IS, YES, IF
YOU THINK SOMETHING IS NOT RIGHT
ABOUT THE CRITIQUE, ABSOLUTELY
LET YOUR PROGRAM OFFICER KNOW
IT'S BETTER THAN JUST A RESPONSE
TO CRITIQUES YOU GET FROM THE
PROGRAM OFFICER, THAT'S FINE,
PLEASE DO THAT.
I DON'T THINK IN MY OPINION --
JUST MY OPINION, I WOULD
PERSONALLY NOT BE IN FAVOR OF
REQUIRING THE REBUTTALS TO ANY
CASE ACROSS THE BOARD.
BUT IF YOU THINK THERE'S
SOMETHING ABOUT THE CRITIQUE YOU
THINK IS INCOMPLETE, NOT RISING
TO THE LEVEL OF A REAL APPEAL
BUT MAKE SURE IT'S CLEAR, YOU
ARE PERFECTLY FREE TO SEND THAT
INFORMATION TO YOUR PROGRAM
OFFICER.
>>I HAVE SEEN A COUPLE GRANTS
AND HAVE ALWAYS BEEN THIS WAY.
I HOPE WE USE IT TO THINK JUST
BEYOND SCIENTIFIC PRIORITIES.
>>DR. CRISWELL: DIVERSITY OF
PERSPECTIVES WITH EARLY CAREER
INVESTIGATORS, AT-RISK
INVESTIGATORS IS UP THERE WITH
NIH-WIDE PRIORITIES.
ED.
>>ED: I'VE HEARD FROM AT LEAST
A TWO OR THREE TIMES THAT IF YOU
IF YOU HEAR FROM A DIRECTOR IT
CAN SACRIFICE YOUR ELIGIBILITY,
I HAVE NO IDEA WHERE I GOT THAT
BUT THINGS LIKE THAT ARE OUT
THERE AND I HOPE I'M NOT
CONTRIBUTING TO PROPAGATE THAT
BUT OUR CONVERSATION AROUND THE
POSSIBILITY OF USING A FORMAL
REBUTTAL PROCESS MIGHT CONFUSE
THE MESSAGE THAT AN INVESTIGATOR
ISN'T REQUIRED TO DO IT.
IF MORE ARE USING THE MECHANISM
IT COULD GET TO THE POINT WHERE
YOUR DISADVANTAGING
INVESTIGATORS WHO CHOOSE NOT TO.
SOME GUIDANCE MAY BE IMPORTANT
ESPECIALLY FOR YOUNGER
INVESTIGATORS.
>>DR. CRISWELL: MY COLLEAGUES
WHO HAVE BEEN INTERACTING WITH
ME THE LAST COUPLE YEARS KNOW I
HAVE A LOT OF CONCERNS --
FORGIVE THE PHRASE A SQUEAKY
WHEEL.
I'M INTROVERT AND SENSITIVE TO
SQUEAKY WHEEL.
MY ANTENNAE GO UP WHEN I GUESS
THE SENSE THAT'S THE ISSUE.
THANK YOU FOR RAISING THE POINT.
BY THE WAY, THERE'S PROGRAM
OFFICERS BEHIND ME WITH VAST
EXPERIENCE AND IF ANY OF THEM
WANT TO ADD TO THE DISCUSSION,
YOU'RE WELCOME TO.
FEEL FREE TO ADD TO THE
DISCUSSION.
DARREN HAS HIS HAND UP AND GAIL
TOO.
>>GAIL: THE PROGRAM DIRECTOR
WILL REACH OUT TO YOU IF THERE
ARE CONCERNS ABOUT THE CRITIQUES
IN THE SUMMARY STATEMENT.
SO IT ISN'T LIKE YOU HAVE TO
ADDRESS THOSE IN ADVANCE.
BUT IF THERE IS INTEREST IN YOUR
APPLICATION AND IT FALLS IN THE
PRIORITY RANGE THE PROGRAM
DIRECTOR IS LOOKING FOR, THEY
WON'T LET A SUMMARY STATEMENT
STAND IN THE WAY.
REST ASSURED.
>>DR. CRISWELL: CAN I ADD, I'VE
BEEN SO IMPRESSED I HAD NO IDEA
THE EXTENT TO WHICH THE PROGRAM
OFFICERS GO TO UNDERSTAND THE
NATURE OF REVIEW.
THEY READ IT CAREFULLY, THEY
READ THE REFERENCES AND CHECK IN
WITH THE ER.
THEY GO THROUGH A LOT OF TROUBLE
TO UNDERSTAND WHY THE CRITIQUES
ARE COMING FROM AND SOMETIMES
THE ASSESSMENT IS IT WAS NOT ON
THE MARK AND THERE WAS A
MISUNDERSTANDING OR MISQUOTE AND
IT CAN IMPACT THE SCORES YOU MAY
NOT HAVE SEEN WITH A DIFFERENT
COLLECTION OF HUMANS.
THERE'S THERE'S SOME HUMAN ERROR
IN THERE TOO.
THEY GO TO A LOT OF TROUBLE TO
TRY TO UNDERSTAND AS WELL AS
THEY CAN THE NATURE OF THE
CRITICISM.
DARREN.
>>I WANTED TO ADD, MY
EXPERIENCE AS A PROGRAM OFFICER
AND ESPECIALLY NOW THAT I'M NOT
A PROGRAM OFFICER I ALWAYS
ENCOURAGE P.I.s TO CONTACT
PROGRAM OFFICERS AND HAVE
DISCUSSIONS.
I'M SURE THE PROGRAM OFFICERS AT
NIAMS ARE VERY PROFESSIONAL.
I'VE SEEN ON SOCIAL MEDIA THE
THINGS PEOPLE WORRY ABOUT IF I
CALL THEM THEY'LL HATE ME AND
WON'T FUND MY GRANT AND THAT
DOESN'T HAPPEN.
THERE'S EIGHT OF THESE THINGS
OUT THERE AND WE HOPE P.I.s
CONTACT WITH REASONABLE
QUESTIONS TO THEIR P.O.s.
I ENCOURAGE IT SO YOU CONTACT
THEM AND NOT ME.
THEY'RE PROFESSIONAL STAFF AND
WON'T USE IN CONSIDERATIONS.
>>DR. CRISWELL: OTHER ISSUES
FOLKS WOULD LIKE TO RAISE?
>>OUR NEXT SPEAKER SAID HE'S
JOIN EARLY.
>>
>>DR. CRISWELL: THAT'S FOUR
MINUTES EARLY.
STRETCH YOUR LEGS, STAY CLOSE
WE'LL START AS SOON AS RICK
WOYCHIK JOINS SO STAY CLOSE
GUYS.
IF YOU NEED TO STAND UP AND
STRETCH YOUR LEGS, FEEL FREE TO
DO SO AND WE'LL CALL YOU AS SOON
AS DR. WOYCHIK JOINS.
>>DR. WOYCHIK: THANK YOU,
DR. CRISWELL FOR THE OPPORTUNITY
TO BE HERE WITH YOU TODAY.
SORRY IT COULDN'T BE IN PERSON
BUT THANKFULLY WE HAVE ZOOM TO
BRING ME TO BETHESDA.
WHAT I'D LIKE TO DO IS TELL YOU
MORE ABOUT SOME OF THE RESEARCH
STRATEGIES THAT WE'RE DEVELOPING
AT THE NIEHS WE HOPE WILL SET
THE STAGE FOR FUTURE
DEVELOPMENTS IN THE
ENVIRONMENTAL HEALTH SCIENCES.
MOST IMPORTANTLY I'M EXCITED TO
HAVE THE OPPORTUNITY TO PRESENT
TO ALL OF YOU BECAUSE WE ARE
VERY INTERESTED IN ESTABLISHING
COLLABORATIONS WITH OTHER I.C.s
INCLUDING NIAMS AND WE'RE DOING
THIS BECAUSE WE HOPE TO ENABLE A
MORE SYSTEMATIC APPROACH FOR
INTEGRATING ENVIRONMENTAL
EXPOSURES INTO STUDYING THE
ETIOLOGY OF HUMAN DISEASE.
TO UNDERSTAND MORE ABOUT NIEHS
LETS START WITH WHAT THE NAME
IMPLIES, WE'RE ABOUT DISCOVERING
HOW THE ENVIRONMENT AFFECTS
PEOPLE IN ORDER TO PROMOTE
HEALTHIER LIVES.
OUR VISION TO IS TO PROVIDE
GLOBAL LEADERSHIP THAT IMPROVES
PUBLIC HEALTH BY PREVENTING
DISEASE AND DISABILITY.
WHAT DIFFERENTIATES ALL THE WORK
FROM THAT ACROSS THE REST OF NIH
WE'RE NOT INTERESTED IN
DISCOVERING CURES BUT PREVENTING
DISEASE.
SO WE'RE INTERESTED IN
IDENTIFYING AND STUDIES THOSE
ENVIRONMENTAL EXPOSURES THAT CAN
HAVE A POSITIVE IMPACT TO HUMAN
HEALTH OR COULD POTENTIALLY
CAUSE ADVERSE HEALTH AFFECTS.
STUDYING THE ENVIRONMENT IS
COMPLICATED.
YOU CAN SEE ON THE SLIDE WE
DEFINE THE ENVIRONMENT BROADLY.
IT INCLUDES A WIDE VARIETY OF
EXPOSURES FROM CHEMICALS FOUND
IN MATERIALS WE USE, POLLUTANTS
IN THE AIR WE BREATHE,
PESTICIDES IN AGRICULTURAL
CHEMICALS, COSMETICS AND
SUNSCREENS AND ANALYZE CHEMICALS
IN THE WORKPLACE AND STUDY
NUTRITION, SLEEP, EXERCISE,
SMOKING, VAPING AND PSYCHOSOCIAL
STRESS AND INTERESTED IN KNOWING
HOW ENVIRONMENTAL EXPOSURES CAN
IMPACT OUR HEALTH.
I -- WHAT DOES THIS HAVE TO DO
BY THE WORK SUPPORT NIAMS.
IT TURNS OUT THERE'S
ENVIRONMENTAL EXPOSURES WITH THE
DEVELOPMENT OF ARTHRITIS AND
RHEUMATIC DISEASE AND SKIN
DISEASES.
FOR EXAMPLE, YOU CAN SEE ON THE
SLIDE THERE'S A LINK BETWEEN
ADULT ONSET R.A. AND CHILDHOOD
EXPOSURE TO RESIDENTIAL
PESTICIDES.
AND THERE'S A DOSE RESPONSE
RELATIONSHIP BETWEEN R.A. RISK
IN MALE FARMERS AND THE
INSECTICIDE.
I DON'T HAVE TIME TO DESCRIBE
ALL THE DETAILS BUT IN
EXPERIMENTS IN GENE BY
ENVIRONMENT EXPERIMENTS, WE NOW
UNDERSTAND THE MOLECULAR BASIS
FOR HOW THE ENVIRONMENTAL
TOXICAN DIOXIN AND HOW IT
INTERACTED WITH THE PATHWAY AND
IT'S DOING THIS IN A WAY THAT
ENHANCE THE CELLULAR EVENTS THAT
CULMINATE IN INFLAMMATION, BONE
DESTRUCTION AND ULTIMATELY
AUTOIMMUNE ARTHRITIS.
AND THERE ARE ENVIRONMENTAL
EXPOSURES THAT IMPACT MUSCLE
AND BONE DISEASES.
PFAS AND THERE'S 12,000
CHEMICALS AND THEY ORIGINATED
WITH TEFLON AND SCOTCH GUARD
WE'VE COME TO APPRECIATE AS
CONSUMERS BUT EXPOSURE TO PFAS
IS ASSOCIATED WITH REDUCED BONE
DENSITY ANDESTERS COMPONENTS
MUCH PESTICIDES AND HERBICIDES
RESULT IN BONE HEALTH AND AIR
POLLUTION IS KNOWN REDUCE BONE
DENSITY IN POST-MENOPAUSAL
WOMEN.
AND IT'S KNOWN THAT AIR
POLLUTION SIGNIFICANTLY
INFECTIOUS THE ODDS OF
DEVELOPING PSORIASIS AND
EMPHYSEMA AND PARAMETERS WE
STUDY AT NIH CAB IMPACT UV
RADIATION AFFECT RESPONSE IN THE
SKIN AND RADIATION CAN PROVIDE
DNA DAMAGE TO LEAD TO GENOME
INSTABILITY AND SKIN LESIONS AND
CANCER.
SO THESE ARE JUST A FEW EXAMPLES
BUT IF WE TRULY WANT TO
UNDERSTAND THE ETIOLOGY OF
ARTHRITIS AND RHEUMATIC DISEASE
AND SKIN DISEASES, IT WILL BE
IMPORTANT TO INCLUDE
ENVIRONMENTAL EXPOSURES INTO THE
EXPERIMENTAL DESIGN.
THERE'S AN ING AWARENESS IF WE
WANT TO UNDERSTAND THE
ENVIRONMENT WE HAVE TO GO BEYOND
OUR TRADITIONAL APPROACH OF
STUDYING ONE EXPOSURE AT A TIME.
THE ENVIRONMENTAL HEALTH
SCIENCES COMMUNITY EMBRACED HAS
COME TO BE REFERRED TO AS THE
EXPOSOME FRAMEWORK ON THE SLIDE.
THIS WILL FACTOR INTO THE
TOTALITY OF EXPOSURES OVER THE
LIFE COURSE AND WILL INCLUDE NOT
ONLY EXPOSURES FROM PHYSICAL,
CHEMICAL AGENTS THAT CAN
INFLUENCE HUMAN HEALTH BUT IT
WILL ALSO INCLUDE THE
ENVIRONMENTAL EXPOSURES I
REFERENCED AT THE BEGINNING OF
MY PRESENTATION.
MANY OF US IN THE BIOMEDICAL
COMMUNITY HAVE BEEN REFERRING TO
THE FRAMEWORK AS IT WAS
DESCRIBED BUT WHAT'S BECOMING
INCREASINGLY CLEAR FOR
INVESTIGATORS OUTSIDE THE NIEHS
COMMUNITY WE NEED A BETTER
UNDERSTANDING HOW TO COLLECT
EXPOSOMIC DATA AND HOW TO DO AN
EXPERIMENT TO INTEGRATE
EXPOSURES FROM OVER THE LIFE
COURSE AND LIFESTYLE VARIABLES.
IT'S COMPLICATED.
TO ADDRESS THIS CHALLENGE, GARY
MILLER, A GRANTEE AND BEEN AN
INVESTIGATOR AT COLUMBIA INVEST
AND AT THE FOREFRONT OF
PROMOTING EXPOSOMICS RESEARCH
INDICATED AT A RECENT MEETING WE
NEED AN OPERATIONAL DEFINITION
OF THE EXPOSOME AND HAS WORKED
WITH OTHERS ACROSS THE GLOBAL
BIOMEDICAL COMMUNITY -- SORRY,
PHONE IS RINGING.
NOT MANY PEOPLE CALL MY PHONE
THESE DAYS.
SO, AT THE PRESENTATION, HE
EXPLAINED TO US WE HAVE TO
BETTER DEFINE HOW TO DO AN
EXPOSOMICS TECHNOLOGY AND IT'S
COMPLICATED AND WE CAN START
WITH THE TECHNOLOGIES WE HAVE
CALLED STUDYING THE PRAGMATIC
EXPOSOME.
WE SHOULD STRIVE TO DEVELOP NEW
TECHNOLOGIES BUT LET'S GET
STARTED WITH THE TOOLS WE
CURRENTLY HAVE AVAILABLE.
WE HAVE SOME POWERFUL TOOLS.
ONE IS HIGH RESOLUTION MASS S
SPECTOMETRY AND WE CAN MODEL HOW
THEY'VE EVOLVED OVER DECADES.
GENOME SCIENCE STARTED WITH
RUDIMENTARY TOOLS DESIGN TO GO
BEYOND STUDYING ONE GENE AT A
TIME.
EARLY GENOMICS EXPERIMENTS
UTILIZED THE TECHNOLOGIES
AVAILABLE IN THE 1990s.
SO WITH THE DECADES OF
IMPROVEMENTS THOUGH WE HAVE COME
TO APPRECIATE POWERFUL
TECHNOLOGIES LIKE SINGLE CELL
SEQ.
LET'S START WITH WHAT WE CAN DO
NOW AND AIM TO DEVELOP
SOPHISTICATED NEW TECHNOLOGIES
FOR CAPTURING THE EXPOSOME.
THERE'S A LOT OF PLANNING THAT
NEEDS TO GET DONE.
AND WE STARTED THIS LAST SUMMER,
NIEHS TOOK THE LEAD TO ASSEMBLE
OVER 400 COLLEAGUES FROM ACROSS
THE BIOMEDICAL COMMUNITY.
MANY COLLEAGUES AT NIAMS
PARTICIPATED IN THESE.
LINDSEY, I THINK YOU WERE THERE
FOR SOME OF THE WORKSHOPS.
THERE WERE FIVE DIFFERENT
WORKSHOPS.
ALL LAST SUMMER USING AN
ENVIRONMENT PLATFORM TO DEVELOP
AN OPERATIONAL TECHNOLOGY FOR
EXPOSOMICS.
FROM THE WORKSHOPS THERE WERE
TOPIC CLUSTERS DISCUSSED.
YOU CAN SEE WE WANT TO IF WE
WANT TO OPERATIONALIZE
EXPOSOMICS WHAT DO WE MEASURE
AND WHAT TOOLS WE NEED AND HOW
TO HARMONIZE THE DATA AND
INTERPRET THE DATA TO BE
TRANSLATED TO IMPACT PUBLIC
HEALTH.
WE NEED A CONCERTED EFFORT TO
DEVELOP A BOLD PLAN FOR
EXPOSOMIC SCIENCE ON A GLOBAL
SCALE.
WE'RE NOT THE ONLY COUNTRY
THINKING OF DOING THIS AND STUD
YIEG -- STUDYING EXPOSOMICS.
NIEHS HAS TAKEN THE LEAD WITH
OTHER ICOs INCLUDING NIAMS,
THANK YOU, AND THE PURPOSE IS TO
SUPPORT A CENTER FOCUSSED ON
GLOBAL EXPOSOMIC RESEARCH TO
ACCELERATE PRECISION IN
ENVIRONMENTAL HEALTH.
I'LL TALK ABOUT IN A COUPLE
MINUTES.
THE OVER ALL GOAL WILL BE TO
DEVELOP A COMMONLY AGREED.
FRAMEWORK FOR EXPOSOMICS AND
LOOK AT METHODOLOGIES THAT
REPRESENT BEST PRACTICES FOR
COLLECTING AND SHARING EXPOSOMIC
DATA AND BUILD A COMMUNITY OF
DIVERSITY AND INCLUSION THAT
FOSTERS NATIONAL AND
INTERNATIONAL COLLABORATIONS.
COUNCIL APPROVED THIS CONCEPT
AND THE EXPECTED RELEASE DATE
FOR THE NOFO IS TOMORROW, AUGUST
30, SO STAY TUNED.
THANKS AGAIN TO NIAMS FOR
SIGNING ON AND WORKING WITH
NIEHS TO PROMOTE THIS IMPORTANT
CENTER.
WE CAN USE THE TECHNOLOGY
AVAILABLE.
THIS IS WHAT WAS REFERRED TO AS
THE PRAGMATIC EXPOSOME.
ONE PRAGMATIC MANNER HAPPENED
WITH FUNDING THAT CAME TO US
FROM THE FUNDING AND WE LAUNCHED
THE HUMAN HEALTH EXPOSURE
ANALYSIS RESOURCE OR PRONOUNCED
HHEAR AND ADDRESSES BIO
MONITORING FOR HYPOTHESIS OF
THIS DRIVEN RESEARCH AND USES
TECHNOLOGIES LIKE NMR TO CONDUCT
THE HYPOTHESIS EXPLORATORY
ANALYSIS IN THE EXPOSOMICS
NETWORK.
IN THE CONTEXT OF STUDYING THE
EXPOSOME AND I WASN'T ON BUT I
THINK YOU COVERED THE EXACT
PLAN, NIEHS IS HAPPY TO LOOB AT
THE COLLABORATION TEAMS PLANNING
AWARDS PROGRAMS.
WE'RE EXCITED ABOUT THIS PROGRAM
IT WILL UTILIZE THE EMERGING
APPROACHES IN EXPOSOME SCIENCE
AND STUDY AUTOIMMUNE DISEASE.
IT'S A PROGRAM TO TEST NOVEL AND
CUTTING-EDGE TECHNOLOGIES AND BE
COMBINED WITH THE NECESSARY DATA
INFRASTRUCTURE THAT WILL ALLOW
US TO BEST UNDERSTAND THE
VARIETY OF EXPOSURES THAT UNDER
LIE BIOMEDICAL DISEASE.
WE'RE INTERESTED IN THE PROGRAM
BECAUSE IT WILL FOSTER THE TYPE
OF COLLABORATION AND
PARTNERSHIPS TO MAKE THE
FRAMEWORK COME ALIVE FOR
STUDYING ETIOLOGY OF HUMAN
DISEASE.
I'LL MOVE ON TO DISCUSS THE NEW
EMERGING AREA IN ENVIRONMENTAL
HEALTH SCIENCES CALLED PRECISION
ENVIRONMENTAL HEALTH.
WHEN I FIRST HEARD ABOUT THE
CONCEPT WHEN CHERYL WALKER AND
THREE GRANTEES TOGETHER
PRESENTED THIS CONCEPT TO NIEHS
COUNCIL AND ADDRESSING THE
VARIABILITY ASSOCIATED WITH
ENVIRONMENTAL EXPOSURES.
NOT EVERYONE RESPONDS IN THE
SAME WAY.
WHAT MAY BE DANGEROUS FOR ONE
INDIVIDUAL MAY NOT APPLY TO
SOMEONE ELSE.
THE PH PROGRAM COMPLIMENTED THE
GENETIC ANALYSES PART OF THE
PRECISION MEDICINE INITIATIVE
BUT IT GOES BEYOND JUST GENETICS
AND INCLUDES EPIGENETICS AND THE
DIFFERENT ENVIRONMENTAL
EXPOSURES THAT FALL UNDER THE
EXPOSOME FRAMEWORK.
THE GOAL OF THE PRECISION
ENVIRONMENTAL HEALTH IS TO
OPENLY UNDERSTAND THE INDIVIDUAL
RISK TO PREVENT DISEASE.
IN A NUTSHELL, CHERYL FINISHED
HER PRESENTATION BY SUMMARIZING
IT AND SAYING PEH IS ABOUT
INTEGRATING GENETICS AND
ENVIRONMENTAL EXPOSURES AND
MASSIVE OMICS DATA SETS.
IT'S ALL ABOUT G x E x D.
AND IN ASSESSING THE
ENVIRONMENTAL HEALTH IT WILL BE
COMPLICATED BECAUSE WE'VE DONE
THE ANALYSES AND WHAT FACTORS
INTO THE RESPONSES OF
ENVIRONMENTAL EXPOSURES FALL IN
THE CATEGORY OF COMPLEX TRAITS.
I KNOW YOU KNOW THIS WELL
STUDYING THE GENETICS OF
AUTOIMMUNITY.
THERE'S VARIATIONS IN HUNDREDS
OF GENES THAT CONTRIBUTE TO THE
WAYS INDIVIDUAL RESPOND TO A
GIVEN ENVIRONMENTAL EXPOSURES
AND TO IDENTIFY THE GENES
INVOLVED WITH THE COMPLEX STAGES
WILL TAKE COHORTS POTENTIALLY
TENS OF MILLIONS OF INDIVIDUALS.
THE GENOMICS COMMUNITY FORMED
THE ICDA THE COMMON DISEASE
ALLIANCE.
THE ICDA AIMS TO DEVELOP
PROCEDURES TO ALLOW THE SEAMLESS
INTEGRATION OF PROGRAMS ACROSS
THE GLOBE.
THE EXPECTATION IS IT WILL ALLOW
M TO M TO M ABOUT THE
DEVELOPMENT OF HIGH RESOLUTION
GENETIC MAPS, UNDERSTANDING THE
DISEASE MECHANISMS ARE
ASSOCIATED WITH THE CONSEQUENCE
VARIATION IN GENES AND APPLYING
THIS TO THE PRACTICE OF
MEDICINE.
MAPS TO MECHANISMS TO MEDICINE.
THE KEY WILL GET THE PROGRAMS TO
COLLECT EPIGENETIC DATA ON THE
COHORTS THEY'RE STUDYING.
THE GOOD NEWS IS WE MADE
PROGRESS ON THE FRONT.
NIEHS JOINED FORCES WITH THE
"ALL OF US" PROGRAM.
IT'S THE HIGHLY DIVERSE COHORT
SPONSORED BY THE NIH PART OF THE
ICDA NETWORK.
SINCE I KNOW DR. CRISWELL HAS
DESCRIBED THE ALL OF US COHORT
LET ME DISCUSS A THREE-PHASE
APPROACH WE'VE BEEN WORKING ON
TO INTEGRATE ENVIRONMENTAL DATA
INTO THE "ALL OF US" PROGRAM.
PHASE 1 INVOLVES INTEGRATING AND
COUPLING TO EACH INDIVIDUAL "ALL
OF US" COHORT LOCAL INFORMATION
AND COORDINATES WITH THE
DATABASES TO PROVIDE WHAT PEOPLE
ARE EXPOSED TO.
AND WE CAN USE EXPOSOMIC TOOLS
AND BY KNOWING WHERE SOMEONE
LIVED AND WORKED SAY FOR EXAMPLE
DURING PREGNANCY WE CAN LINK
INDIVIDUAL TO EXPOSURES IN
DATABASES WITH DAILY WEATHER
DATABASES AND MODELS AND THE CDC
SOCIAL VULNERABILITY INDEX AND
THE CDC ENVIRONMENTAL JUSTICE
INDEX.
BY MAKING THE LINKS WE'RE ABLE
TO CAPTURE A VARIETY OF
ENVIRONMENTAL EXPOSURES.
FOR EXAMPLE, AIR POLLUTION.
WE CAN ESTIMATE WHAT PEOPLE ARE
EXPOSED TO FROM THE FOREST FIRES
COMING FROM OUR NORTHERN
NEIGHBOR IN CANADA.
THIS IS A START INTEGRATING THE
GEOSPATIAL INFORMATION ANDEST
-- AND EFFORTS ARE UNDERWAY TO
BRING THIS DATA INTO THE ALL OF
US PROGRAM.
IN THAT LIGHT, AS PART OF PHASE
3, WE'VE DEVELOPED A PILOT
PROJECT INVOLVING 1500 TYPE II
DIABETICS AN CONTROLS.
NOT ALL 600,000 INDIVIDUALS BUT
A SUB SET OF OF THE COHORT TO
GIVE IT A TEST AND THE PLAN IS
TO LEVERAGE THE SEQUENCE AND
ELECTRONIC HEALTH RECORDs AND
DATA FROM EXTENSIVE SURVEY
QUESTIONS OF LIFESTYLE AND
SOCIAL DETERMINATES OF HEALTH
AND TOOLS LIKE HIGH RESOLUTION
MASS SPECT TO UNDERSTAND HOW
GENES INTERACT TO INFLUENCE THE
DEVELOPMENT OF TYPE II DIABETES.
WE HOPE THE PILOT WILL BE A
MODEL FOR CONDUCTING LARGER
SCALE EXPERIMENTS SAY IN STAGE 2
AND MOVE TO OTHER TOPICS OF
INTEREST INCLUDING
AUTOIMMUNITIES.
LET ME IN THE REMAINING TIME I
HAVE TAKE YOU INTO ANOTHER AREA
AND TO UPDATE YOU ON SOME RECENT
PROGRESS ON THE EFFORTS WE'VE
BEEN MAKING ON ADDRESSING THE
CHALLENGES ASSOCIATED WITH
CLIMATE CHANGE AND HEALTH.
AS I BELIEVE YOU'VE ALL HEARD,
THE PRESIDENT HAS MADE
ADDRESSING THE CHALLENGES
ASSOCIATED WITH CLIMATE CHANGE
THE HIGH PRIORITY FOR HIS
ADMINISTRATION AND RECOGNIZES
THERE ARE A NUMBER OF VERY
IMPORTANT HEALTH RELATED ISSUES
THAT NEED TO BE ADDRESSED WITH
CLIMATE CHANGE.
THEREFORE HE ISSUED EXECUTIVE
ORDER 14008 WHICH IS ABOUT
TACKLE THE CLIMATE CRISIS AT
HOME AND ABROAD AND SPECIFICALLY
POINTED TO THE NIH TO TAKE ON
THE CHALLENGES ASSOCIATED WITH
THE HEALTH AFFECTS ASSOCIATED
WITH CLIMATE CHANGE.
TO FUEL THIS EFFORT HE PROVIDED
$40 MILLION TO NIEHS IN THE FY23
BASE BUDGET SO IT WILL THERE BE
IN SUBSEQUENT YEARS AND WHILE
THE MONEY IN THE NIEHS BUDGET,
WE'VE DECIDED THIS IS A TOPIC
THAT IS MUCH BIGGER THAN WHAT
ANY SINGLE I.C. CAN ACCOMPLISH
ON ITS OWN AND ABUNDANTLY CLEAR
THERE'S OTHER INSTITUTES AND
CENTERS WITH A KEEN INTEREST IN
THE AREA OF RESEARCH.
THIS IS AN INTEREST THAT GOES
BEYOND WHAT JUST NIEHS HAS.
I'VE TAKEN THE INITIATIVE TO
REACH OUT TO -- THIS WAS EARLY
ON REACHING OUT TO DR. GIBBONS
AT NHLBI AND DR. GLASS AT THE
FOGARTY INTERNATIONAL CENTER AND
NOW THE ACTING DIRECTOR AT
FOGARTY, DR. GORDON AT NIEMS AND
DR. PEREZ-STABLE AND WE HAVE
FORMED WHAT WE'RE CALLING AN
EXECUTIVE COMMITTEE ON CLIMATE
CHANGE AND HEALTH.
WE'VE RE-ENERGIZED A MEMBER
GROUP INCLUDING STAFF AT NIAMS.
THE WORKING GROUP IS CO-CHAIRED
BY NIEHS AND JOSH ROSENTHAL AT
FOGARTY AND WE'RE KEEPING ALL
THE MOVING PARTS WORKING
TOGETHER.
AND THERE'S A STEERING GROUP
WITH DESIGNATED APPOINTEES FROM
THE I.C.s REPRESENTED ON THE
EXECUTIVE COMMITTEE AND WE HAVE
RECENTLY EXPANDED THE STEERING
COMMITTEE TO INCLUDE MEMBERS
FROM A NUMBER OF OTHER I.C.s
INCLUDING NIAMS.
THANK YOU, LINDSEY AND BOB FOR
INCLUDING OTHER MEMBERS.
THE STEERING COMMITTEE IS
WORKING WITH DR. ROSENTHAL AND
MILLER TO MAKE SURE THE GOALS
ARE ACHIEVED.
THE WORKING GROUP HAS BEEN VERY
BUSY OVER THE PAST COUPLE OF
YEARS ON MANY PROJECTS MOST
NOTABLY ON THE DEVELOPMENT OF AN
NIH-WIDE STRATEGIC FRAMEWORK FOR
CLIMATE CHANGE AND HEALTH.
BEFORE I GO INTO DESCRIBING THAT
FRAMEWORK, THIS SLIDE
ILLUSTRATES THE ENORMOUS
COMPLEXITY ASSOCIATED WITH HOW
CLIMATE IMPACTS HEALTH.
THERE'S CLIMATE DRIVERS THAT
AFFECT HEALTH OUTCOMES AND THEY
CAN DO THIS DIRECTLY THROUGH A
NUMBER OF AFFECTS THAT RANGE
FROM HEAT-RELATED ILLNESS TO
POOR MATERNAL AND BIRTH OUTCOMES
AND AFFECTS RANGE FROM CHEMICAL
RELEASES IN THE ENVIRONMENT TO
THE ECONOMIC IMPACTS THAT CAN
RESULT IN MORE PEOPLE LIVING IN
POVERTY.
OVER ALL AS YOU MIGHT IMAGINE WE
LOOK AT IT WITH AN EXOME OMIC
FRAMEWORK, LOTS OF VARIABLES TO
CONSIDER.
AND I WANT TO EMPHASIZE ANY PLAN
TO EXECUTE ON THE CLIMATE CHANGE
AND HEALTH MUST INCLUDE A
RECOGNITION THAT CLIMATE CHANGE
DOESN'T AFFECT EVERYONE EQUALLY.
UNDER RESOURCED AND MARGINALIZED
POPULATIONS, FARM WORKERS AND
THOSE WITH EXACTS ARE AFFECTED
AND YOUNG CHILDREN, FETUS AND
WOMEN AND THOSE IN VULNERABLE
STAGES AND CHRONIC CONDITIONS
ARE AFFECTED BY CLIMATE CHANGE
AND POPULATIONS IN LOW AND
MIDDLE INCOME COUNTRIES ARE
EXPOSED DUE TO HIGH RATES OF
MALNUTRITION.
THE STRATEGY INCLUDED PORTFOLIO
ANALYSIS AND THINGS WE'RE DOING
ACROSS THE NIH, STRATEGY WHI
WHITEBOARDING SESSION AND
RESPONSES FROM AN RFI ISSUED
BACK IN AUGUST OF 2021.
THE FRAMEWORK IS ILLUSTRATED
WITH THE DIAGRAM WE CALL IT THE
COG DIAGRAM FOR OBVIOUS REASONS.
IT'S BASED ON FOUR ELEMENTS
INCLUDING HEALTH AFFECTS AND
HEALTH EQUITY, TRAINING AND
CAPACITY BUILDING AND
INTERVENTION SCIENCE.
THERE'S A FOCUS ON
TRANSFORMATIVE RESEARCH AND THE
WORK WILL BE CONDUCTED WITH
GLOBAL CROSS-SECTOR INTERAGENCY
PARTNERSHIPS THE BLUE RING.
THE COGS ARE MEANT TO ILLUSTRATE
THE TYPES OF SCIENCE THAT WILL
NEED TO BE CONDUCTED TO SUPPORT
THE FRAMEWORK.
YOU CAN SEE THE TYPE IS SMALL
BUT THERE'S LOTS OF DIFFERENT
TYPES OF RESEARCH THAT NEEDS TO
BE CONDUCTED.
THESE RANGE FROM BASIC
MECHANISTIC RESEARCH HOW HEAT
AFFECTS HUMAN PHYSIOLOGY AND
BEHAVIORAL SCIENCE RESEARCH AND
PREDICTIVE MODEL TO ADAPTATION
RESEARCH.
WE JUST DEVELOPED A WEBSITE FOR
CLIMATE CHANGE AND HEALTH.
IT'S NIH.gov/CLIMATEANDHEALTH.
YOU CAN SEE THE ELEMENTS ON THE
COG DIAGRAM AND WE'RE BUILDING
TO BUILD STRATEGIES TO USE THE
$40 MILLION FROM CONGRESS TO
SUPPORT THE NIH-WIDE INITIATIVE
ON CLIMATE CHANGE AND HEALTH.
LET ME PAUSE FOR A SECOND HERE.
LET ME SEE HOW I'M DOING ON
TIME.
>>DR. CRISWELL: WE'RE DOING,
FINE, RICK.
THANKS FOR CHECKING IN.
>>DR. WOYCHIK: LET ME TALK
ABOUT THE DETAILS OF HOW WE'RE
SPENDING THE $40 MILLION.
OVER ALL THE APPROACH WE
DEVELOPED INVOLVES ULTIMATELY
WITH A U54 AND U.S. AND GLOBAL
CENTERS OF EXCELLENCE.
TO ACHIEVE THIS WE'RE PUTTING
TOGETHER A NUMBER OF THINGS
PUTTING IN FY23 ONE IS THE
ACE-CH AND THE U-24 RESEARCH
COORDINATING CENTER AND
INITIATED A P20 EXPLORATORY
PLANNING CENTER AS A STEPPING
STONE TO ADDRESS THE U54
U.S. AND GLOBAL CENTERS OF
SCLENGS PROGRAM.
-- EXCELLENCE PROGRAM.
ACE-CH WILL ALLOW US TO ENGAGE
COMMUNITIES MOST IMPACTED UNDER
SERVED AND RURAL POPULATION.
IT'S A PROGRAM ADMINISTERED
USING THE OTA MECHANISM ALLOWING
US TO GET MONEY ON THE STREET
QUICKLY.
THE COORDINATING CENTER IS
DESIGN TO BUILD RESEARCH DATA
AND ADVANCE THE PRIORITIES
ESTABLISHED IN THE NIH CLIMATE
CHANGE AND HEALTH STRATEGIC
FRAMEWORK, THE COG DIAGRAM.
WE EXPECT THE RCC WILL BRING NIH
FUNDED RESEARCH WITH THE
SCIENTIFIC COMMUNITY AND
INTERAGENCY PARTNERS TO FORM THE
COMMUNITY OF PRACTICE RESEARCH
NETWORK.
THE P20 CENTER PROGRAM WILL BE
USED TO DEVELOP A RESEARCH
ENVIRONMENT FOR FUNDAMENTAL
RESEARCH.
WE EXPECT THE CENTERS WILL
DEVELOP ACTION-ORIENTED
SOLUTIONS FOR HEALTH HAZARDS
OPPOSED BY THE CLIMATE CHANGE
AND COLLABORATION BETWEEN
RESEARCH TEAMS FOR THE PURPOSE
OF SUPPORTING THE FOUR CORE
ELEMENTS OF HEALTH RESEARCH AND
EQUITY AND INTERVENTION RESEARCH
AND TRAINING AND CAPACITY
BUILDING.
THE FIRST DEADLINE WAS MAY 1.
WE'RE REVIEWING THE FIRST SET OF
PROPOSALS AND THERE WILL BE
ANOTHER DEADLINE NOVEMBER 7.
IF YOU'RE INTERESTED, STAY
TUNED.
I ALSO WANTED TO COMMENT THE NEW
PROGRAM INVOLVES A NUMBER OF
DIFFERENT THINGS.
IT INCLUDES THE IT INCLUDES
THE --'S WHAT WE CALL THE NIH
CLIMATE AND HEALTH SCHOLARS
PROGRAM.
THIS PROGRAM WILL BE PROVIDE
SUPPORT TO BRING EXTRAMURAL
SCIENTISTS IN THE AREA OF
CLIMATE CHANGE AND BRING THEM ON
CAMPUS TO WORK TOGETHER WITH
STAFF AT THE NIH.
SCHOLARS WILL BE INVITED TO
COLLABORATE ON ONE OR MORE
ACTIVITIES WITH TRAINING AND
POLICY AND WILL BE A UNIQUE
OPPORTUNITY FOR SCIENTISTS
OUTSIDE THE U.S. FEDERAL
GOVERNMENT TO SHARE THEIR
PASSION WITH LABORATORIES,
PROGRAM OFFICERS AND OTHERS
ACROSS THE NIH.
EIGHT SCHOLARS WERE SELECTED
FROM ACADEME ANDINDUSTRY AND
HOSTED BY THE I.C.s SHOWN ON THE
SLIDE.
THERE'S A SECOND ROUPD OF
APPLICATIONS IN JUNE AND WE'RE
CURRENTLY REVIEWING THOSE.
IF THIS IS SUCCESSFUL WE MAY GO
FOR AN ADDITIONAL AMOUNT IF WE
GET SUPPORT FROM THE EXECUTIVE
COMMITTEE.
SO SUMMARIZE IT ALL, IF YOU'RE
INTERESTED VISIT THE CLIMATE
CHANGE AND HEALTH WEBSITE TO
PROVIDE MORE INFORMATION ABOUT
THE INITIATIVE AND FRAMEWORK AND
IF YOU WANT MORE INFORMATION
ABOUT EXISTING AND HOPEFULLY
FUTURE FUNDING ANNOUNCEMENTS,
TAKE A LOOK AT THE WEBSITE AND
WE CONTINUE TO SUPPORT THE
SEMINAR SERIES AND WE DEVELOPED
A LITERATURE PORTAL.
THEPORT AL -- THE PORTAL HAS E
MOST RELEVANT SCIENTIFIC
LITERATURE RELATING TO CLIMATE
CHANGE.
NIH AND NIAMS HAVE A LOT OF
COMMON INTERESTS AND I THINK WE
CAN FORM STRONG PARTNERSHIPS.
WE CAN STUDY THE ENVIRONMENTAL
FACTORS WITH HEALTH OUTCOMES AND
DISEASES THAT FALL WITHIN THE
MISSION AREAS.
WE CAN WORK TOGETHER TO DEVELOP
A FRAMEWORK TO DECIDE THE GENE
BY ENVIRONMENT INTERACTIONS TO
PREVENT DISEASE.
THANK YOU AGAIN OR THE
OPPORTUNITY TO PRESENT.
>>DR. CRISWELL: THAT WAS
INCREDIBLE AND RELEVANCE ACROSS
THE NIH.
THAT WAS A FANTASTIC OVERVIEW
AND APPRECIATED YOUR CALLING OUT
SOME WAYS IN WHICH NIAMS HAD THE
OPPORTUNITY TO COLLABORATE WITH
YOU.
WE'RE BIG FABZ OF WHAT YOU'RE
TRYING TO DO.
I SEE SEVERAL HANDS UP STARTING
WITH LUIS GARZA.
>>LUIS: EDWARD BOTCHWEY ALSO
HAD HIS HAND UP SO WE DON'T WANT
TO MISS HIM.
THANK YOU FOR THE GREAT
PRESENTATION.
IT'S BEEN ON MY MIND A LOT.
I DO RESEARCH AND PRACTICE
MEDICINE AND DERMATOLOGY.
AS MY CAREER'S GOTTEN LONGER
SOME DISEASES ARE BECOMING MORE
PREVALENT AND INCIDENCES GOING
UP A LOT IT'S CLEAR THEY'RE
PROBABLY ENVIRONMENTAL.
A LOT OF RESEARCHERS WHO AREN'T
IN THE CLINIC DON'T KNOW THAT
AND I THINK AS THE WORLD IS
INCREASINGLY SATURATED WITH
CHEMICALS AND NO ONE IS COOK AT
HOME ANY MORE AND THE EXPOSURES
ARE GOING UP A LOT.
ONE THING I'M CURIOUS OF IS
THERE A CENTRAL CANARY IN THE
COAL MINE EFFORT TO SAY LET'S
LOOK AT ALL ICD9 CODE AND TRACK
WHICH ONES ARE GOING UP THE
FASTER LIKE IN THE LAST 20 YEARS
FOR EXAMPLE.
THAT'S HOW YOU'LL SEE THE DATA.
PEOPLE WON'T KNOW WHAT TO LOOK
FOR UNLESS THEY SEE THE DISEASE
IS GOING UP A LOT IN INCIDENTS.
IT SEEMS LIKE YOU GUYS WOULD BE
A GREET PLACE TO CURATE SUCH A
LIST.
CAN YOU EXPOUND ON THAT EFFORT?
>>DR. WOYCHIK: THAT'S A GREAT
SUGGESTION AND WE HAVEN'T DID
THAT BUT YOU'RE RIGHT.
THERE'S A NUMBER OF DISEASES THE
INCIDENTS ARE INCREASING AND
HUMAN BEINGS ARE NOT EQUAL.
THE GENETICS ARE NOTE CHANGING
THAT QUICKLY.
THERE MAY BE A GENE BY
ENVIRONMENT BUT THERE HAS TO BE
VARIABLES WITHIN THE ENVIRONMENT
THAT ARE CAUSING THAT.
THAT'S A GREAT SUGGESTION.
I'LL HAVE TO BRING THAT BACK TO
MY COLLEAGUES AND MAYBE LINDSEY
THAT'S SOMETHING WE CAN BE
TALKING ABOUT.
LOOK AT THE DISEASES AND
INCIDENTS.
>>DR. CRISWELL: THE ORDER OF
HANDS IS DIFFERENT ON MY SCREEN
THAN UP ABOVE SO NOT SURE WHAT
TO GO BY.
I'LL CALL OUT ED NEXT.
>>ED: THANK YOU FOR THE
PRESENTATION.
I THINK IT'S AN INCREDIBLY
IMPORTANT TOPIC.
I WANT TO FRAME MY COMMENT WITH
A COUPLE OBSERVATIONS I'VE BEEN
EXPOSED TO, NO PUN INTENDED OVER
THE LAST COUPLE YEARS.
IN CONSIDERING DISPARITY THE
LIFE EXPECTANCY BETWEEN BLACKS
AND WHITES HAS BEEN NARROWING
NATIONALLY BUT WHEN YOU LOOK AT
PARTICULAR LOCATIONS AND LET'S
CONSIDER WASHINGTON, D.C. AS ONE
OF THEM, WHILE THE LIFE
EXPECTANCY NATIONALLY HOVERING
AROUND FOUR YEARS DIFFERENCES
BETWEEN BLACKS AND WHITES IT'S
ALMOST 18 IN WASHINGTON, D.C.
WHY IS THAT?
ONE OF MY Ph.D. MENTOR, KATO
LORENZEN IN 2020 HE PUBLISHED A
PERSPECTIVE PIECE ON THE
INTERSECTIONS OF RACISM AND THE
GLOBAL PANDEMIC AND IT MAKES
THIS OBSERVATION QUITE CLEARLY
ANTI-BLACK RACISM IN MANY
CONTEXTS IS A PERNICIOUS HEALTH
CARE EXPOSURE CONTRIBUTING TO A
MYRIAD OF DISEASES AND HEALTH
CARE IMPACTS.
SOME OF WHICH ARE WITHIN THE PER
VIEW AND MISSION OF NIAMS.
THE LAST COMMENT I WANTED TO
MAKE AND ASK A QUESTION IS THAT
AT GEORGIA TECH I HAD THE
OPPORTUNITY TO START A SEED
PROGRAM WHERE WE REALLY WANTED
TO LOOK AT MODELS OF RACISM,
ANIMAL MODELS AND WAYS TO
INCLUDE COMPONENTS LIKE
PSYCHOSOCIAL STRESSES AND OTHER
FACTORS THAT MAY BE CONTRIBUTING
TO THE DISPARATE OUTCOMES AS IT
RELATES TO RACE AND IT'S BEEN
INTERESTING AND WITH MICE WE SAW
PROFOUND CHANGES DRIVEN BY
THINGS LIKE A BIOMEDICAL
RESEARCHER, PSYCHOSOCIAL STRESS
IS NOT SOMETHING I WAS TRAINED
TO THINK MUCH ABOUT BUT THE MORE
WE THINK OF THE ROLE OF THE
IMMUNE SYSTEM PLAYS IN VIRTUALLY
EVERYTHING WE STUDY AND WE KNOW
PSYCHOSOCIAL STRESSES CAN DRIVE
CHANGES IN INFLAMMATION AND
IMMUNITY IT BEGS THE QUESTION,
HOW CAREFULLY SHOULD WE BE
LOOKING AT THE INTERSECTIONS
BETWEEN SOME OF THE DRIVERS OF
CHANGES IN IMMUNE RESPONSE AND
MANY OF THE DISEASES AND INJURY
MODELS THAT WE HAVE.
SO THAT WAS REALLY THE GENESIS
OF THE PROGRAM WE STARTED AT
GEORGIA TECH.
THIS IS MY CONCERN, GRANTED, I'M
CONCERNED THAT THE RECOGNITION
OF RACE AS A VARIABLE
CONTRIBUTING TO DISPARATE HEALTH
OUTCOMES IS BECOMING CLEARER
POTENTIALLY IN AN ENVIRONMENT
WHERE THE ABILITY TO EXPLICITLY
ADDRESS RACE CAN BE MORE
COMPLICATED IN OUR SOCIETY AND
ALSO IN OUR RESEARCH COMMUNITY.
I WANTED TO TAKE THIS
OPPORTUNITY TO KIND OF ASK SINCE
WE'RE TALKING ABOUT SOME OF
THESE ENVIRONMENTAL EXPOSURES
AND PSYCHOSOCIAL STRESSES ARE
MENTIONED, IS THIS A PROBLEM?
TO WHAT EXTENT ARE WE LIMITED
POTENTIALLY BY THIS CONCEPTION
OF THE SOCIAL CONSTRUCT OF RACE
AND THE SOMEWHAT SENSITIVITYIES
DR. ADDRESSING IT IN THE COURSE
OF OUR RESEARCH?
>>DR. WOYCHIK: THANK YOU FOR
THE QUESTION.
THERE'S A LOT OF CONTENT IN THE
COMMENT YOU JUST MADE THERE.
PSYCHOSOCIAL STRESS AND WE NEED
THE ELEMENTS THAT GO WITH RACISM
ARE INTEGRATED INTO THIS EXP
EXPOSOMICS FRAMEWORK AND YOU'RE
PROBABLY AWARE OF THE FACT
THERE'S MODIFICATIONS ASSOCIATED
WITH STRESS.
ONE OF THE ELEMENTS OF THE
EXPOSOME IS TO GO BEYOND RACE
AND TO START DEVELOPING
OBJECTIVE BIOMEDICALS TO
EVALUATE THE IMPACTS OF
PSYCHOSOCIAL RACISM.
I KNOW LINDSEY IS INTERESTED IN
THIS TOO AT LOOKING AT THE
EPIGENETIC MARKERS AND HOW YOUR
GENES ARE WORKING.
TO ADDRESS YOUR QUESTION, IS
EMBRACING THE EXPOSOME FRAMEWORK
GOING BEYOND PHYSICAL AND
CHEMICAL EXPOSURES AND LOOKING
AT THE TOTALITY OF EXPOSURES AND
DEVELOPING A MECHANISM TO ASSESS
THOSE ENVIRONMENTAL EXPOSURES IS
GOING TO BE THE WAY WE CAN
CONNECT THE EXPOSOME WITH
BIOLOGICAL CONSEQUENCES.
LET ME ALSO ADDRESS THE ISSUES
THAT YOU RAISED AND I JUST WANT
TO PUT IN A PLUG FOR THE
ENVIRONMENTAL JUSTICE EFFORTS
THAT WE ARE SPEARHEADING AT
NIEHS.
THERE'S A LOT OF THINGS WE'RE
DOING AND IN THE LIMITED TIME I
HAVE I COULDN'T COVER
EVERYTHING.
IN ADDITION TO THE PSYCHOSOCIAL
STRESSES IN SOME NEIGHBORHOODS
IN WASHINGTON, D.C. OR OTHER
PARTS OF THE COUNTRY, IT'S NOT
THE HIGH-INCOME GROUPS
NEIGHBORHOODS LOCATED DOWN WIND
OF LED SMELTERS AND LOCATED TO
SUPER FUND SITES.
THERE'S ENVIRONMENTAL JUSTICE
ELEMENTS HERE.
IN FACT, ALL OF OUR
ENVIRONMENTAL HEALTH SCIENCES
CENTER HAVE A COMMUNITY
ENGAGEMENT CORPS.
THAT MEANS THEY HAVE TO REACH
OUT TO THE COMMUNITIES OF THOSE
IMPACTS BY THE ENVIRONMENTAL
JUSTICE.
I WAS RECENTLY VISITING BAYLOR
AND THEY TOOK ME ON A TOXIC
TOUR.
I THINK IT'S A 35-MILE STRETCH
OF FREEWAY FROM HOUSTON TO THE
DIFFICULT OF MEXICO.
IF ANY OF HAVE YOU BEEN ON THAT
STRIP OF ROADWAY, IT'S DIFFICULT
TO BREATHE THE AIR.
IT'S BUMPER TO BUMPER OIL
REFINERIES AND THERE ARE LOW
INCOME AND RACIAL MINORITY
NEIGHBORHOODS LOCATED NEXT TO
THESE PETROLEUM PROCESSING PLANT
AND THEY'RE NOT HAPPY ABOUT
THAT.
I CAN IMAGINE THIS IS ABSOLUTELY
AFFECTING THEIR HEALTH IN VERY
SERIOUS AND DELETERIOUS WAYS.
WE'RE INTERESTED IN GENERATING
THE DATA SO THE ORGANIZATIONS
THAT CAN DO SOMETHING ABOUT
ENVIRONMENTAL JUSTICE AND THE
EPA HAS A BUDGET TO DEAL WITH
ISSUES OF ENVIRONMENTAL JUSTICE
AND WE ARE GENERATING THE DATA
SO IT PROVIDES A COMPELLING
REASON TO GO IN AND DO SOMETHING
IN THESE NEIGHBORHOODS.
EDWARD, DOES THIS BEGIN TO
ADDRESS THE QUESTIONS YOU
RAISED.
>>DR. CRISWELL: I SEE LEIGH AND
THEN JINOOS AFTER THAT.
LEIGH.
>>LEIGH: THANK YOU FOR AN
EXCELLENT PRESENTATION.
I NOTED THE EXPOSOME FRAMEWORK
HAS A LOT OF SIMILARITIES OR
CROSSOVER WITH THE SOCIAL
ECOLOGICAL MODEL AND ALSO IN
ADDITION TO WHAT LUIS SAID
THINKING ABOUT SURVEILLANCE.
I WONDERED WHEN YOU TALK ABOUT
COMMUNITIES AN YOU THINK ABOUT
STATE HEALTH DEPARTMENTS, WHAT
THE ROLE OR COLLABORATION WITH
THE CDC IS BECAUSE THE SOCIAL
ECOLOGICAL MODELS USED A LOT IN
PUBLIC HEALTH AND PREVENTION AND
SEEMS THERE COULD BE
COLLABORATIONS THERE.
>>DR. WOYCHIK: OF COURSE AND
THERE'S A VIRTUAL COLLABORATION
THE NIH, CDC AND FDA BUT
SPECIFICALLY OTHER PROGRAMS
WITHIN THE CDC WE'RE TIGHTLY
CONNECTED WITH THEM.
I FIRST BECAME DIRECTOR JUST
OVER THREE YEARS AGO I SET OUT
FIVE LEADERSHIP PRINCIPLES.
AND ONE IS COLLABORATION.
IT'S COLLABORATING NOT JUST WITH
THE 26 OTHER INSTITUTES AND
CENTERS AT THE NIH BUT
COLLABORATING WITH OTHER FEDERAL
AGENCIES OR NON-GOVERNMENTAL
AGENCIES WHERE IT MAKES SENSE.
THE COLLABORATION HAS ALWAYS
BEEN A FRAMEWORK OF MY OWN
RESEARCH PROGRAM AND LAB AND WE
CAN NOW BRING THAT SAME SPIRIT
OF BRINGING IN COMPLIMENTARY
EXPERTISE TO WORK TOGETHER TO
TAKE ON THE BIG CHALLENGES
ASSOCIATED WITH PUBLIC HEALTH.
ABSOLUTELY CDC HAS BEEN A MAJOR
PARTNER WITH US IN MANY
DIFFERENT WAYS.
AND SPECIFICALLY WHEN YOU LOOK
AT THE GEOSPATIAL DATA.
CONNECTING IT WITH THE CDC
ENVIRONMENTAL JUSTICE INDEX AND
COUPLING IT WITH THE CDC SOCIAL
DETERMINATES OF HEALTH.
SO THOSE ARE VERY TANGIBLE
PARTNERSHIPS THAT WE'LL BE
USING, DEVELOPING AS PART OF THE
ALL OF US PROGRAM.
DOES THAT ANSWER YOUR QUESTION?
>>JINOOS: IT'S EXCITING TO HEAR
ABOUT ALL THE INITIATIVES AND
PROGRAMS.
I HAVE A QUESTION FOR YOU ABOUT
THIS COMMUNICATION ISSUES AROUND
CLIMATE CHANGE HAVE BECOME VERY
POLITICIZED AND I'M WONDERING
WHAT STRATEGIES YOU WILL EMPLOY
TO EFFECTIVELY COMMUNITY
CLIMATE-RELATED HEALTH RISK THAT
COMES FROM THE RESEARCH.
>>DR. WOYCHIK: WE CAN FOLLOW
THE GUIDANCE FROM DR. FAUCI,
STICK WITH THE SCIENCE AND STAY
OUT OF THE POLITICS AND THAT'S
WHAT WE TRY TO DO.
WE BRIEF OUR APPROPRIATORS ON A
REGULAR BASIS AND THEY WERE
PLEASED TO KNOW HOW WE'RE USING
THE $40 MILLION TO LAUNCH THIS
PROGRAM ULTIMATELY.
I THINK THEY BUY INTO THE MOTION
OF ULTIMATELY DEVELOPING THE
U-54 COLLABORATION CENTER AND
WE'VE ADDRESSED WITH THE OTHER
I.C. DIRECTORS AND LINDSEY HAS
EXPRESSED A LOT OF INTEREST IN
GETTING MORE IMPORTANTLY
INVOLVED AND WE'RE TRYING TO
FIND THE MECHANISMS TO HOPEFULLY
KEEP YOU OFF THE STREET AT NIGHT
AND GET YOU MORE INVOLVED IN THE
CLIMATE CHANGE AND HEALTH
PROGRAM BUT COMMUNICATION IS
IMPORTANT.
AGAIN, FOCUSSING ON THE SCIENCE.
WHAT'S THE DATA.
WHAT ARE THE THINGS THAT NEED TO
GET DONE AND STAYING OUT OF THE
POLITICS OF WHETHER CLIMATE
CHANGE IS ACTUALLY BEING I THINK
THE BIG POLITICS OR WHETHER IT'S
A MANDATE CONDITION OR NOT THE
FACT OF THE MATTER IS WE'RE ALL
BREATHING IN WILDFIRE SMOKE FROM
CANADA RIGHT NOW AND TAKE A LOOK
AT THE TEMPERATURE INDEX IN THE
SOUTHEAST AND SOUTHWEST IT'S
REAL DATA.
SO WHATEVER IT IS IT'S SOMETHING
THAT THE NIH WITH OUR CLIMATE
CHANGE AND HEALTH FOCUS CAN
ACTUALLY GET IN AND ADDRESS SOME
OF THOSE HEALTH-RELATED ISSUES.
SO DOES THAT ANSWER YOUR
QUESTION?
>>JINOOS: I DO WONDER IF HAVING
A STRATEGY AROUND SCIENCE
COMMUNICATION IS ESPECIALLY
IMPORTANT IN THIS COMING DECADE
INCLUDING THE MEANS THAT MAYBE
WE DON'T TRADITIONALLY USE AS
MUCH.
I AGREE STICKING WITH THE
SCIENCE AND SOCIAL MEDIA AND
OTHER WAYS PEOPLE ARE CONSUMING
INFORMATION IT FEELS LIKE THERE
NEEDS TO BE AN INTENTIONAL
STRATEGY AROUND COMMUNICATION.
>>DR. WOYCHIK: WE NEED TO
CHANGE MINDS.
WHAT WE CAME TO APPRECIATE WITH
COVID-19 IS THAT SIMPLY
COMMUNICATING THE VERY POWERFUL
RESEARCH RESULTS.
YOU'RE COMMUNICATING THE FACT
THAT WE HAVE DEVELOPED MANY
DIFFERENT VACCINES AND WE DID
THIS IN AN UNPRECEDENTED TIME
FRAME WITH AN UNPRECEDENTED
DEGREE OF EFFICACY AND PEOPLE
WILL LINE UP TO GET THEIR SHOTS
AND THAT DIDN'T HAPPEN.
ENGAGING AUDIENCE IN A
COMPELLING WAY SO THEY
UNDERSTAND THE ISSUES AND
IMPORTANTLY IT'S NOT COMING
ACROSS AS A LECTURER.
PEOPLE DON'T LIKE TO BE LECTURED
ABOUT THE SCIENTIFIC DATA.
WE HAVE BEEN INTERFACING WITH
JOURNALISTS WHO KNOW HOW TO
COMMUNICATE AND IN FACT I WAS
INVITED AND JOURNALISTS HAVE A
RETREAT I THINK EVERY FALL AND
THEY TALK ABOUT COMMUNICATION
STRATEGIES.
WE TALKED ABOUT THE CHALLENGES
WITH CLIMATE CHANGE AND HEALTH.
AND THERE'S LOTS OF VARIABLES.
DOES THAT ANSWER YOUR QUESTION?
>>JINOOS: I'M GLAD YOU'RE
TALKING TO JOURNALISTS.
KEEP THAT UP.
>>DR. WOYCHIK: WE LEARNED A LOT
OF FROM COVID-19.
>>DR. CRISWELL: IT'S BEEN A
MAJOR ONGOING DISCUSSION ACROSS
NIH AND NIH LEADERSHIP LEVEL.
TWO OTHER QUESTIONS LINED UP,
BOB CARTER AND VALENTINA GRECO
HAS A QUESTION AND BOB.
>>BOB: THIS IS CIRCLING BACK
BUT LUIS TALKED ABOUT EMERGING
DISEASES BUT I DON'T KNOW THE
DATA BUT WONDERING IF SOME OF
THE GROUP DOES.
HEARING AUTOIMMUNE DISEASES AND
R.A. IN PARTICULAR ARE
INCREASING.
THE QUESTION IS FIRST OF ALL,
TWO QUESTIONS, ONE IS HOW VALID
IS THAT CONCLUSION?
IS IT DISEASE SPECIFIC?
THREE QUESTIONS, AND CAN YOU
LINK THAT TO THOSE INCREASES IN
THE SPECIFIC AUTOIMMUNE
DISEASES.
JINOOS KNOWS ABOUT EPIDEMIOLOGY
AND WHAT IS THE DATA THERE?
I'M WONDERING IF THEY KNOW HOW
GOOD THAT DATA IS.
>>DR. WOYCHIK: THERE'S CASES OF
AUTISM AND IT'S GOING UP QUICKLY
AND THERE'S NEURO GENETIC
COMPONENTS AUTISM BUT ARE THE
INCIDENTS GOING UP BECAUSE WE'RE
DIAGNOSING AUTISM NOW BETTER
THAN WE WERE PREVIOUSLY?
ALSO, IT'S COLON CANCER.
THE EARLY STAGE COLON CANCER IS
ON THE RISE BIG TIME.
AND IT'S ACTUALLY WHEN YOU LOOK
AT THE DATA IT'S PRETTY
STRIKING.
THE QUESTION IS, IS IT STRICTLY
GENETIC DRIVERS OR ARE THERE
ENVIRONMENTAL PARAMETERS
ASSOCIATED WITH EARLY STAGE
COLON CANCER.
THAT'S SOMETHING WE'VE BEEN
EXPLORING WITH PEOPLE WHO STUDY
COLON CANCER.
ARE THERE ENVIRONMENTAL FACTORS
THAT CAN BE INFLUENCING THAT?
AND WITH THE GENETIC EMPHASIS
USING PRECISION ENVIRONMENTAL
HEALTH APPROACH YOU CAN SEGMENT
YOUR POPULATIONS INTO
GENETICALLY SUSPECTABLE
INDIVIDUALS AND THERE'S A
TRIGGER THAT CAUSES THE DISEASE.
IT'S COMPLICATED.
JUST WITH THOSE COMMENTS SO IF
THERE'S SOMEONE ELSE THAT CAN
SPEAK MORE INTELLIGENTLY ABOUT
DOING SOME OF THOSE ASSESSMENTS,
I'D BE VERY INTERESTED TO HEAR
WHAT THEY HAVE TO SAY.
>>DR. CRISWELL: JUDITH JAMES
WHO JOINED US FOR COMMENTS IN
THE NEXT SECTION PUT A NICE
COMMENT IN THE CHAT, NICE PAPER
FROM THE U.K. SHOWS AUTOIMMUNE
DISEASES R.A. IS INCREASING BUT
NUMBERS OF SJOGREN'S IS
DRAMATIC.
MARIA SUAREZ-ALMAZOR WERE YOU
GOING CHIME IN?
I SAW YOU TURN ON YOUR CAMERA.
>>MARIA: I DON'T HAVE THE DATA
OR NUMBERS BUT I THINK THE
INCREASE IN AUTOIMMUNE DISEASE
HAS BEEN RELATED TO VARIOUS
FACTORS AND THERE'S AN INCREASE
IN THE PREVALENCE OF ANTIBODIES
AND AUTOIMMUNITY CAN BE
CONTRIBUTED TO DIFFERENT
FACTORS.
>>JINOOS: IN RESPONSE TO
DR. CARTER'S QUESTION ABOUT
WHETHER THE DATA IS STRONG, I
WOULD SAY THE ANSWER TO THAT IS,
NO.
THE DATA NEEDS TO BE STRONGER.
THERE'S SIGNAL IN SEVERAL AREAS
AND SOME POPULATION-BASED
STUDIES THAT SHOW INCREASES.
THERE'S SOME INTERESTED DATA
ABOUT AUTOANTIBODIES WITH A
RISING PREVALENCE OF A AND A
TESTS IN SOME POPULATIONS BUT I
ACTUALLY THINK THIS IS AN AREA
THAT NEEDS MORE RESEARCH AND WE
HAVE LIKE A VERY INTERESTING
OPPORTUNITY ALSO TO LOOK ACROSS
THE COUNTRY AT COMMUNITIES THAT
HAVE STRIKINGLY HIGHER
PREVALENCE OF AUTOIMMUNE DISEASE
AND ONE EXAMPLE IS THE NAVAJO
NATION.
WE SEE RATES OF RHEUMATOID
ARTHRITIS UNPARALLELED TO MANY
AREAS AND NEED MORE RESEARCH TO
BE DONE.
>>DR. WOYCHIK: YOU BRING UP THE
ENVIRONMENTAL POPULATION AND THE
ENVIRONMENTAL EXPOSURES IN THAT
COMMUNITY IS UNBELIEVABLE.
WHEN YOU'RE TRYING TO DO IT ONE
EXPOSURE AT A TIME, YOU MAY NOT
BE GETTING A POTENTIAL
SYNERGISTIC AFFECT AND THERE MAY
BE A SYNERGISM BETWEEN POLLUTION
AND THE URANIUM TAILINGS IN SOME
COMMUNITIES.
IT'S AWFUL THE THINGS WE'VE DONE
TO THESE DIFFERENT INDIGENOUS
COMMUNITIES.
TEASING OUT THE DIFFERENT
ENVIRONMENTAL EXPOSURES AND
USING EXPOSOMIC FRAMEWORK AND
FACTORING IN THE PSYCHOSOCIAL
STRESS AND OTHER VARIABLES THAT
MAY BE INFLUENCING HUMAN HEALTH.
>>DR. CRISWELL: THANK YOU FOR
THAT QUESTION AND THE RESPONSES
AND I KNOW VALENTINA HAD A
QUESTION.
>>VALENTINA: THANK YOU VERY
MUCH MY VOICE IS CORRUPTED SO
THE PRESENTATION WAS INCREDIBLE
FOR THE UMBRELLA PROGRAM THE
POWER AND THE HOPE IT CAN
GENERATE AND WANTED TO BUILD ON
SOMETHING BEFORE COVID AND OTHER
INSTANCES WE LEARN FROM HISTORY
THAT UNEQUAL DISTRIBUTION OF
POWER WE HAVE IN SOCIETY AND
WHEN WE GO INTO THE DEFINITION
AS WE GO AND LOOK FOR OBJECTIVE
MEASURES AND INCREDIBLE DATABASE
COLLECTION BECAUSE THE POWER IS
LOCATED IN THE MINORITY MOSTLY
WHITE, MOSTLY MALE, THERE'S A
RISK THOSE DATA AND THE PROCESS
BY WHICH THEY'RE COLLECTED AND
LOOKED AT ARE NOT REFLECTIVE OF
OTHER SOCIETY.
WHAT PRESSURES ARE ON THE
INITIATIVE OR PEOPLE BEING AT
THE TABLE HAVING A DISTRIBUTION
OF POWER BEYOND THE DOMINANT
GRO
GROUP.
>>DR. WOYCHIK: IT'S COMMUNITY
ENGAGEMENT AND DIVERSITY OF
APPROACHES.
I DIDN'T CAPTURE ALL THE -- MY
AUDIO IS A LITTLE BIT MESSED UP.
I DIDN'T CAPTURE ALL THE
QUESTION BUT BUT COMMUNITY
ENGAGEMENT IS IMPORTANT.
DOES THAT ADDRESS YOUR QUESTION?
>>VALENTINVALENTINA: IT'S NOT
AUDIO PERHAPS MY VOICE.
I CAN E-MAIL YOU.
>>DR. WOYCHIK: LINDSEY CAN
FORWARD IT TO.
>>DR. CRISWELL: THERE'S AN
E-MAIL FROM JOHN O'SHAY HE'S
ASKING ABOUT OPPORTUNITIES FOR
INTRAMURAL RESEARCH
INVESTIGATORS WITH RESPECT TO
THE SCHOLARS PROGRAM AND
SPEAKING OF PARTNERSHIPS, HOW TO
ENGAGE THE INTRAMURAL RESEARCH
COMMUNITY -- WOW, I JUST GOT A
DIFFERENT VIEW.
>>DR. WOYCHIK: HOW INTERESTING.
>>DR. CRISWELL: I DIDN'T DO
ANYTHING.
THIS IS INTERESTING.
IF YOU CAN SPEAK TO HOW YOU
THINK OF INTRAMURAL AND
EXTRAMURAL COLLABORATIONS AND
STARTING WITH THE SCHOLARS
PROGRAM WHETHER THAT'S OPEN TO
INTRAMURAL INVESTIGATORS.
>>THAT WAS ME.
WE WERE LOOKING AT SOME
SOMETHING.
>>DR. WOYCHIK: LET ME KNOW HOW
YOU DID THAT AS LONG AS YOU
DON'T TURN MY FACE INTO A KITTEN
FACE.
ISN'T THAT'S WHAT HAPPENED TO
THE LAWYER?
>>I'LL TRY.
>>DR. WOYCHIK: I DIDN'T HAVE A
CHANCE TO TALK ABOUT THE
INTRAMURAL RESEARCH PROGRAM.
WE RECOGNIZE THERE'S SOME REAL
TALENT AND A LOT OF INTEREST
EMBRACING THE SCIENTIFIC FOCUS
IN THE COG PROGRAM.
WE LAUNCHED THE ITCH PROGRAM.
IT'S REALLY MEANT TO BE -- SO
CLIMATE CHANGE -- THE
INTRAMURAL -- FORGOT WHAT THE
"H" STANDS FOR BUT IT'S AN
INTRAMURAL PROGRAM DEDICATED TO
STUDYING THE HEALTH AFFECTS OF
CLIMATE CHANGE.
SO WE'VE BEEN WORKING TOGETHER
WITH DARYL ZELDON THE SCIENTIFIC
DIRECTOR AT NIEHS AND REACHING
TO ALL SCIENTIFIC DIRECTORS
ACROSS NIH TO DEVELOP A PROGRAM
AND THE EXECUTIVE TOSSED IN A
LITTLE BIT OF MONEY TO HELP
SUPPORT THE DEVELOPMENT OF A --
IT WOULD BE A COLLABORATIVE
CENTER ACROSS THE INTRAMURAL
PROGRAM.
AND TO FUNCTION AS ESSENTIALLY
THE CHIEF OF THIS COLLABORATIVE
CENTER AND THAT'S A RECRUITMENT
CURRENTLY UNDERWAY.
IT'S BEING DRIVEN BY DR. ZELDIN
AND HIS COLLEAGUES AND NOT JUST
COLLEAGUES AT NIEHS BUT ACROSS
THE NIH.
THE SUCCINCT ANSWER TO THE
QUESTION IS JUST LIKE WITH THE
GENERAL RESEARCH PROGRAMS AND
THE VARIOUS I.C.s, ABOUT 10% OF
THE BUDGET COULD BE TO SUPPORT
WORK IN THE INTRAMURAL PROGRAMS.
>>DR. CRISWELL: HE WAS ASKING
ABOUT THE SCHOLARS CLIMATE
CHANGES PROGRAM.
>>DR. WOYCHIK: IS A TO TRIGGER
PROGRAMS IN HEALTH.
>>COULD THEY BE ASSIGNED
>>DR. WOYCHIK: THEY COULD BE
ASSIGNED.
>>I WANT TO MAKE SURE OUR
PEOPLE ARE APPLYING.
>>DR. CRISWELL: GREAT.
THANK YOU SO MUCH.
ANY OTHER QUESTIONS FOR
DR. WOYCHIK WHILE HE'S STILL
WITH US?
AND ANYBODY, VALENTINA OR OTHERS
WHO THINK OF A QUESTION TO POSE
YOU CAN SEND IT KNOW OR DARREN
AND WE CAN PASS IT ALONG TO
RICK.
YOU'RE RICK.WOYCHIK@NIH.gov.
THERE'S TWO MORE COMMENTS IN THE
CHAT.
HOPEFULLY EVERYBODY AROUND THE
TABLE AND ONLINE AND NICE
COMMENTS FROM LUIS GARZA AND
MATLOCK JEFFERIES AND MORE
COMMENTS ABOUT DATA ON
OSTEOARTHRITIS.
>>DR. WOYCHIK: VERY
INTERESTING.
LINDSEY, I LOOK FORWARD -- I
WILL SEE YOU THURSDAY MORNING.
>>DR. CRISWELL: THAT'S RIGHT.
BRIGHT AND EARLY.
SEE YOU THEN.
THANK YOU FOR JOINING US.
>>DR. WOYCHIK: THANKS TO ALL OF
YOU AND YOUR QUESTIONS AND I
LOOK FORWARD TO CONTINUING THE
DIALOGUE BYE, EVERYONE.
>>DR. CRISWELL: SO, DARREN AND
I WERE CONFERRING ABOUT THE
TIMING HERE.
SO LET'S TAKE A 10-MINUTE
STRETCH BREAK BUT WE'LL TRY TO
RECONVENE ABOUT 11:45 EASTERN SO
WE'RE STILL 15 MINUTES AHEAD OF
SCHEDULE WHICH I THINK WILL HELP
US TOWARDS THE END OF THE OPEN
SESSION.
TEN MINUTES FOLKS.
>>CLINICAL DIRECTOR OF THE
EYE INSTITUTE AND RESEARCH
INTERESTS INCLUDE OCULAR
DISEASES AND THE ROLE OF SEX AND
GENDER IN HEALTH AND DISEASE.
IN 2021, DR. CLAYTON WAS ELECTED
TO THE BOARD OF DIRECTORS OF THE
AMERICAN ASSOCIATION FOR THE
ADVANCEMENT OF SCIENCE.
NOW UNFORTUNATELY DR. CLAYTON
WASN'T ABLE TO ATTEND BUT
RECORDED A VIDEO WHERE SHE'LL
PROVIDE AN UPDATE FOR ORWH AND
NIAMS' COLLABORATION.
AS YOU'RE HEARING COLLABORATION
WITH NIAMS IS A THEME FOR TODAY.
IT'S MY PLEASURE TO BE WITH YOU
TODAY VIRTUALLY TO TALK ABOUT
ADVANCING THE HEALTH OF WOMEN
AND PROVIDE AN UPDATE ON ORWH
AND NIAMS' COLLABORATION.
AND NIAMS DISEASE IS IMPORTANT
TO THE HEALTH OF WOMEN AND
SCIENCE CAREERS FOR MANY YEARS.
WHILE WE ARE ONE OF THE FIRST
ICO FUNDING PARTNERS OF THE
OSTEOARTHRITIS INITIATIVE IN
2001.
WE'VE CO-FUNDED LUPUS OVER THE
YEARS LED BY NIAMS.
ORWH STAFF HAVE SUPPORTED THE
WORKING GROUPS ON BONE DISEASES
AND NIAMS SENIOR LEADERSHIP
CO-CHAIRED ONE OF THE MOST
IMPORTANT ASPECTS OF OUR NIH
WIDE STRATEGIC PLAN AND THE
DEVELOPMENT PROCESS AND WE PLAN
TO RELEASE THAT LAST YEAR SO
WE'RE EXCITED ABOUT THAT.
AND NOW NIAMS IS PROVIDING
PARTNER-ON THE -- PARTNERSHIP
ON THE OFFICE OF AUTOIMMUNE
DISEASE RESEARCH.
IT'S BEEN A CRITICAL PARTNER IN
THE CONTINUITY SUPPLEMENTS
SUPPORTING RESEARCHERS WHO
EXPERIENCE QUALIFYING LIFE
EVENTS OR CAREGIVING
RESPONSIBILITIES AND SUPPORTING
EARLY-STAGE INVESTIGATOR RPGs OR
RESEARCH PROJECT GRANTS.
JUST A BIRDS-EYE VIEW AS WELL AS
THE AMP AIM PROGRAM ACCELERATING
MEDICINES PARTNERSHIPS WHICH I
WILL TALK ABOUT MORE ORWH HAS
BEEN SUPPORTING SCIENCE IN THAT
PROGRAM AND I WILL TALK A LITTLE
BIT ABOUT MORE LATER.
AS WE BEGIN I WANT TO SHARE THE
WAY ORWH THINKS OF EQUIPMENT AND
WE BELIEVE THAT WOMEN'S HEALTH
IS EVERYTHING THAT AFFECTS WOMEN
FROM HEAD TO TOE AND THE LIFE
PERSPECTIVE AND CRITICALLY
IMPORTANT.
THE PRE-PREGNANCY HEALTH OF
WOMEN IS VERY IMPORTANT AS WELL
AND AT AN INDIVIDUAL LEVEL THE
LIFE COURSE THROUGH THE
TRANSITION OCCUR ARE IMPORTANT
TO CONSIDER WHEN YOU THINK ABOUT
THE HEALTH OF WOMEN FROM THE
WHOLE PERSON HEALTH PERSPECTIVE.
BIOLOGY, SEX, AGE, ANCESTRY, FOR
EXAMPLE, ARE CRITICAL.
EXTERNAL FACTORS SUCH AS WOMEN
IN CONTEXT OF SOCIETY SUCH AS
GENDER AS A SOCIAL CULTURAL
VARIABLE, GENERATIONAL
DIFFERENCES, SOCIO POLITICAL
EXPOSURES AND TOXICANTS ARE ALL
IMPORTANT AND THEY INTERACT WITH
EACH OTHER ACROSS THE LIFE
COURSE TO AFFECT THE HEALTH OF
WOMEN.
ONE OF THE MAIN FOCUSES OF ORWH
AT THE PRESENT TIME IS IMPORTANT
TO MANY OF US HERE AND NIAMS AND
THAT'S CHRONIC DISEASES.
IN 2021 WE RECEWERE ASKED TO EXE
MATERNAL MORTALITY AND
INCREASING RATES OF CHRONIC
DEBILITATING CONDITIONS IN
WOMEN.
AS A RESULT WE HOSTED ADVANCING
NIH RESEARCH ON THE HEALTH OF
WOMEN 2021 CONFERENCE ON THE
THREE TOPICS AND THE INCREASING
RATES OF CHRONIC DEBILITATING
CONDITIONS WAS THE PRIMARY FOCUS
AREA.
THE PUBLICATION OF OUTCOMES OF
THIS CONFERENCE ARE INCLUDED
HERE.
CHRONIC CONDITIONS IN WOMEN AND
THE HEALTH FRAMEWORK WHERE WE
TALK WITH THE FACT WE NEED TO
THINK ABOUT DISEASES THAT ARE
MORE COMMON IN WOMEN, HAVE A
HIGHER BURDEN IN WOMEN OR MIGHT
BE DISPROPORTIONATELY AFFECTING
WOMEN AND DISEASES UNDER STUDIED
IN WOMEN AS WE THINK THROUGH
THAT.
AND FOLLOW-UP ORWH SPONSORED A
STUDY ON CREATE FRAMEWORK FOR
THE CONSIDERATION OF CHRONIC
DEBILITATING CONDITIONS IN WOMEN
AND WE LOOK FORWARD TO THE
OUTCOMES OF THAT STUDY.
IN THIS I WANT TO HIGHLIGHT SOME
OF OUR COLLEAGUES IN THE SPACE A
NATURE EDITOR WHO HIGHLIGHTED
THE UNDER STUDIED ASPECTS OF
WOMEN'S HEALTH RESEARCH ACROSS
THE ECO SYSTEM.
AND THE FACT THAT CONDITIONS
SUCH THAT ARE HIGHLY PREVALENT
AND HAVE A LARGE IMPACT ON
SOCIETY BASED ON DISABILITY
ADJUSTED LIFE YEARS ARE NOT
NECESSARILY THOSE CONDITIONS
THAT RECEIVE THE MOST FUNDING.
THE NATIONAL INSTITUTE OF
MUSCULOSKELETAL HAS THE HIGHEST
SUPPORT FOR WOMEN'S HEALTH
RESEARCH AND IT'S BEEN OUR
DISTINCT PLEASURE TO PARTNER AND
COLLABORATE WITH NIAMS.
AS A FOLLOW-UP FROM THE WOMEN'S
HEALTH CONFERENCE I MENTIONED WE
GENERATED THIS REPORT WHICH IS
AVAILABLE ON OUR WEBSITE ON
PERSPECTIVES ON ADVANCING NIH
RESEARCH TO INFORM AND IMPROVE
THE HEALTH OF WOMEN.
WE HIGHLIGHTED THE FACT THAT
MULTIPLE CHRONIC DISEASE MORE
COMMON IN WOMEN AND PART OF THE
STRATEGY PLAN AND GOAL ONE TO
ADVANCE RIGOROUS RESEARCH
RELEVANT TO THE HEALTH OF WOMEN.
WE ISSUED WITH OUR PARTNERS
INCLUDING NIAMS AND NHLBI AND
NCI AND THE OFFICE OF AIDS
RESEARCH TWO NEW FUNDING
OPPORTUNITIES AND R21 AND R01
FOCUSSED ON UNDERSTANDING
CHRONIC CONDITIONS UNDER STUDIED
AMONG WOMEN.
AND UNDERSTAND THE IMPORTANCE OF
THE CHRONIC DISEASE FRAMEWORK
AND LOOKING AT CONDITIONS LIKE
MENOPAUSE AND LOOKING AT
AUTOIMMUNITY AND MENTAL HEALTH
AND CONDITIONS UNDER STUDIED IN
WOMEN LIKE COPD AND CONDITIONS
WITH HIGH MORBID FOR WOMEN.
AND SO WE ARE EXCITED TO HAVE
THAT FUNDING OPPORTUNITIES
AVAILABLE TO THE SCIENTIFIC
COMMUNITY TO INVESTIGATE THE
CRITICAL AREAS.
AND THE 2022 CONSOLIDATED
APPROPRIATION ACT OF 2023
CONGRESS DIRECTED THE FORMATION
OF THE OFFICE OF AUTOIMMUNE
RESEARCH IN ALIGNMENT WITH A
RECENT NATIONAL ACADEMIES REPORT
ON ENHANCING NIH RESEARCH IN
AUTOIMMUNE DISEASES.
THE CONGRESSIONAL DIRECTIVES
INCLUDE COORDINATING DEVELOPMENT
OF A STRATEGIC RESEARCH PLAN,
IDENTIFYING EMERGING AREAS OF
INNOVATION AND RESEARCH
OPPORTUNITY, COORDINATING AND
FOSTERING COLLABORATIVE RESEARCH
ACROSS THE I.C.s OR INSTITUTES
AND CENTERS AND EVALUATING THE
RESEARCH AND PLANNING AND
COLLABORATION AND DEVELOPING A
PUBLICLY ACCESSIBLE CENTRAL
REPOSITORY FOR AUTOIMMUNE
RESEARCH.
IT'S MY PLEASURE TO SHARE WITH
YOU SOME PRELIMINARY INFORMATION
FROM FY23 THE FIRST YEAR OF ODR.
WE RECEIVED APPLICATION FOR
SUPPORT OF AUTOIMMUNE RESEARCH
FROM 11 INSTITUTES AND CENTERS
AND FUNDING AWARDS AND
INTRAMURAL TRAINING AWARD AND IT
WILL INCLUDE THE EXACT PLAN
AWARDS WHICH WE'LL BE TALKING
ABOUT LATER TODAY.
SO WE'LL BE SUPPORTING A RANGE
OF AUTOIMMUNE DISEASE TOPICS
RANGE FROM THYROID DISEASE TO
MULTIPLE SCLEROSIS, TYPE I
DISEASE AND OTHER AUTOIMMUNE
DISEASES AND EXCITE ABOUT THE
INAUGURAL RESEARCH FUNDING FOR
AUTOIMMUNE DISEASE RESEARCH.
THE NOES -- NOSI IS A CRITICAL
FUNDING OPPORTUNITY AND INVITES
EXPLORATORY AND CONCEPTUAL
PROJECTS AIMED AT THE DESIGN,
DEVELOPMENT AND IMPLEMENTATION
OF A FUTURE NATIONAL
INTERDISCIPLINARY TEAM SCIENCE
RESEARCH NETWORK OR EXACT.
SO WE ARE EXCITED WITH OUR
PARTNERS DELIBERATED YEAR
ESPECIALLY IN THE EHS AND NIAMS
TO MOVE FORWARD WITH THIS ROBUST
PLAN TO SUPPORT FUTURE EFFORTS.
I ALSO WANT TO SHARE WITH YOU A
VARIETY OF OTHER CRITICAL
PARTNERSHIPS THAT ORWH HAS WITH
NIAMS.
OUR CAREERS, EFFORTS SUPPORT THE
RECRUITMENT, RETENTION, REENTRY
AND SUSTAINED ADVANTAGE
ADVANCEMENT OF WOMEN IN MEDICAL
CAREERS AND THERE'S PROGRAMS
HIGHLIGHTED IN MY REMARKS.
FIRST WE TRY TO MAKE SURE WOMEN
IN SCIENCE RECEIVE THE RESEARCH
SUPPORT AND TRAINING THEY NEED
BOTH AT THE INSTITUTIONAL LEVEL
THROUGH INSTITUTIONAL AWARDS AND
THE INDIVIDUAL LEVEL.
AT THE INSTITUTIONAL LEVEL, OUR
BUILDING INTERDISCIPLINARY
RESEARCH PROGRAM WE'RE
PARTNERING ON PROGRAM
ADMINISTRATION AND I WILL TALK
MORE ABOUT THAT.
OUR TEAM SCIENCE EFFORTS AND
LEADERSHIP SCHOLARS PROGRAM IS
ALSO A COLLABORATION WITH AMP
AIM AND NIAMS SUPPORTS THE OTHER
EFFORTS.
OVER 90 GRANTS AND P.I.s ARE
CURR
CURRENTLY HAVE BEEN SUPPORTED
AND WE SUPPORTED OVER 700
SCHOLARS, THESE ARE WOMEN'S
HEALTH RESEARCH THAT HAVE GONE
ON TO RESEARCH AFTER THE
INSTITUTIONAL K AWARD.
WE HAVE MULTIPLE INSTITUTES AND
CENTERS COLLABORATING, 22 ACTIVE
BIRCH PROGRAMS AND THEY'RE
PARTNERING WITH HISTORICALLY
BLACK COLLEGES AND UNIVERSITIES.
THE TEAM SCIENCE EFFORT IS A
PILOT PROGRAM TO HELP WOMEN'S
HELP SCHOLARS ACQUIRE LEADERSHIP
SKILLS AND YOU'LL HEAR MORE
ABOUT THAT MOMENTARILY.
OUR CAREER CONTINUITY AWARDS
ADDRESS CRITICAL LIFE EVENTS OF
FIRST-TIME RPG RECIPIENTS OR K
AWARDEES BECAUSE WE KNOW THAT
TRANSITION FROM K TO R IN THE
FIRST RPG TO RENEWAL OR SECOND
RPG IS AN ADMINISTRATION POINT
WHERE WE TEND TO LOSE SCIENTISTS
FROM THE RESEARCH CONTINUUM.
RETENTION OF OUR INVESTIGATORS
THROUGH OUR SUPPLEMENTS ALLOW
INDIVIDUALS WHO EITHER LEAVE
RESEARCH OR NEED TO MOVE FROM AN
UNSAFE ENVIRONMENT TO ANOTHER
ENVIRONMENT SO WE PROVIDE THIS
MECHANISM THROUGH THE RE-ENTRY
AND RE-INTEGRATION SUPPLEMENTS.
TO GET MORE DETAIL ABOUT THE
BIRCH AND YOU KNOW CAREER
DEVELOPMENT FOR WOMEN S.T.E.M.
IS A MAIN MISSION AREA.
THIS WAS ONE OF OUR FIRST
PROGRAMS WITH A SPECIAL
CONGRESSIONAL APPROPRIATION IT
REMAINS OF INTEREST TO CONGRESS
AND HAVE TWO APPROPRIATIONS
SPECIFIC FOR THE PROGRAM IN THE
LAST TWO FISCAL YEARS THERE'S 19
ACTIVE AWARDS INDICATED IN THE
TURQUOISE WITH THE GRANTS IN
THOSE STATES CO-FUNDING VARIES
ACROSS EACH OF THE RFA
RE-ISSUANCES AND WE HAD PARTNERS
LOOKING AT OTHER PARTNERS AS
WELL.
12 OF THE 19 CURRENT GRANTEES
HAD MULTIPLE P.I.s AND AS I
MENTIONED 50 SCHOLARS COMPLETED
THE PROGRAM, 88% STAYED IN
RESEARCH AND 42% ARE PHYSICIAN
SCIENTISTS.
THE MAJORITY OF THE SCHOLARS ARE
WOMEN.
.
I WANTED TO HIGHLIGHT WAYS WE'RE
LEVERAGING THE PROGRAM.
IT'S ENTITLED SEX DIFFERENCES IN
MAJOR DEPRESSION IMPACT OF
PRENATAL STRESS AND THE
AUTONOMIC DYSREGULATION AND
BUILDING A TRANSLATIONAL
INNOVATION NETWORK.
THE PROJECT IS ELEVATING THE
SCIENTIFIC MISSION OF THE SCORE
AND SPECIALIZED CENTERS ON SEX
DIFFERENCES INCLUDING A CAREER
ENHANCEMENT CORE BY FORMULATING
A PIPELINE THAT'S COLLABORATING
ACROSS THE SCORE PROGRAMS AND
CREATE BUILDING ACADEMIC AND
INDUSTRY FOR PUBLIC-PRIVATE
PARTNERSHIPS AND COLLABORATION
SCORE INSTITUTIONS AND THE
PROGRAM AT HARVARD.
ANOTHER EXAMPLE OF THE
INNOVATIVE WAY WE'RE SUPPORTING
THE SCIENCE CAREERS.
I HIGHLIGHT THE CONTINUITY AND
RETENTION SUPPLEMENTS THESE ARE
SUPPORTING JUNIOR INVESTIGATORS
FROM THE K AWARDEES TRANSITION
FROM THE MENTORED CAREER
DEVELOPMENT TO RESEARCH
INDEPENDENCE AND THE FIRST TIME
RECIPIENTS ARE SEEKING TO HAVE A
RENEWAL OR SECOND AWARD.
RE-ENTRY AND REINTEGRATION
SUPPLEMENTS ADDRESS TRANSITION
POINTS AS WELL AS BARRIERS AND
OBSTACLES TO QUALIFYING LIFE
EVENTS, MEN AND WOMEN.
IT'S BEEN OUR PLEASURE TO
COLLABORATE AND PARTNER ON
LAUNCHING THE LEADERSHIP
SCHOLARSHIP PROGRAM IN WOMEN'S
HEALTH AND IMMUNE DISEASES AND
TRAINS WOMEN'S HEALTH SCHOLARS
AND IMMERSIVE COLLABORATIVE
EXPERIENCES THAT PRIORITIZES
TEAM SCIENCE AND I WANT TO
PROVIDE AN UPDATE FROM MY
PREVIOUS PRESENTATION AT
COUNCIL.
WE'RE EXCITED TO BE ALMOST READY
TO FINALIZE OUR LIST OF THE
FIRST SCHOLARS AND ASPECTED
START DATE JUST AROUND THE
CORNER.
SO THIS IS A CAREER DEVELOPMENT
AND RESEARCH PARTNERSHIP BETWEEN
ORWH NIAMS AND THE OFFICE OF
DATA SCIENCE STRATEGY.
AND THE PROGRAM WILL BE MANAGED
BY THE OKLAHOMA MEDICAL RESEARCH
ASSOCIATION ON BEHALF OF AMP AIM
AND I WANTED TO RECOGNIZE JUDITH
JAMES AND JULIE GERBERDING FOR
THEIR LEADERSHIP IN ALLOWING THE
PROGRAM TO MOVE FORWARD AND
NIAMS AS WELL AND THE AWARDEES
HAVE BEEN SELECT BASED ON THEIR
RESEARCH TO AUGMENT AND LEVERAGE
AMP AIM WITH DATA SCIENCE AND
MACHINE LEARNING, PEDIATRIC
POPULATIONS, BEHAVIORAL AND
SOCIAL EXPOSURES AND A VARIETY
OF AUTOIMMUNE DISEASE EFFORTS.
WE'LL FORMALLY ANNOUNCE THESE IN
SEPTEMBER WITH TWO YEARS OF
FUNDING BEING PROVIDED BY THE
THREE ICOs YOU HAVE LISTED HERE.
IT'S BEEN MY PLEASURE TO SHARE
WITH YOU JUST A FEW OF THE WAYS
THAT ORWH AND ORWH AND NIAMS AND
DR. CRISWELL AND OTHER FORS FOR
THE COLLABORATION AND GETTING
ORWH OFF THE GROUND.
SO IF YOU WANT TO CONNECT WITH
ORWH FOLLOW US THROUGH OUR
MONTHLY NEWSLETTER OR SIGN UP
FOR OUR QUARTERLY PUBLICATION,
WE HAVE A VARIETY OF E-LEARNING
OPTIONS ON SEX AND GENDER TO
IMPROVE HUMAN HEALTH, MODELS ON
IMMUNOLOGY, BENCH TO BEDSIDE
COURSES, AND CMEs ARE AVAILABLE
FOR SOME OF THESE COURSE.
IT'S MY PLEASURE TO BE WITH YOU.
THANK YOU VERY MUCH FOR YOUR
ATTENTION.
>>DR. CRISWELL: THANK YOU.
WE CAN GO BACK INTO GALLERY
VIEW.
A REMINDER FOR FOLKS TO BE IN
THE ZOOM MEETING.
WONDERFUL.
SO BEFORE I OPEN THINGS UP I
WANTED TO FIRST CALL ON
DR. JUDITH JAMES SHE IS THE
EXECUTIVE VICE PRESIDENT AND
CHIEF MEDICAL OFFICER OF THE
OKLAHOMA MEDICAL RESEARCH
FOUNDATION AND ALSO THE
PROFESSOR AND PROGRAM CHAIR OF
THE ARTHRITIS AND CLINICAL
IMMUNOLOGY RESEARCH PROGRAM.
JUDITH, THANK YOU FOR JOINING US
AND FOR MAKING COMMENTS ON
BEHALF OF AMP AIM EFFORT.
>>JUDITH: THANK YOU,
DR. CRISWELL ON THE AUTOIMMUNE
MEDIATED DISEASES, THANK YOU TO
THE OFFICE OF RESEARCH IN
WOMEN'S HEALTH TO NIAMS AND THE
OFFICE OF DATA SCIENCE STRATEGY
FOR CHOOSING THE AMP AIM AS THE
PARTNER ENTITY FOR THIS EXCITING
PILOT PROGRAM TO HELP DEVELOP
MORE TEAM SCIENCE LEADERS IN
DISEASES IMPORTANT TO WOMEN'S
HEALTH ESPECIALLY STARTING IN
AUTOIMMUNE SKIN AND RHEUMATIC
DISEASES.
WE'RE EXCITED BY THE
INVESTIGATORS BEING PRIORITIZED
FOR FUNDING AND ENTHUSIASTIC
ABOUT THE NEW AREAS OF
SCIENTIFIC INVESTIGATION, NEW
POPULATIONS AND NEW DATA
ANALYTIC APPROACHES THAT THESE
INVESTIGATORS WILL BRING TO THE
AMP AIM NETWORK.
WE ALSO LOOK FORWARD TO
INTEGRATING THESE INTO THE
INVESTIGATORS INTO PROJECTS IN
THIS TEAM SCIENCE PROGRAM
THROUGH OUR WORKING GROUPS,
THROUGH COMMITTEE SERVICE,
THROUGH BEING INVOLVED IN THE
PROJECTS.
WE ALSO LOOK FORWARD TO
COLLABORATIVELY ESTABLISHING
DIDACTIC AND MENTORING PROGRAMS
FOR THE INVESTIGATORS IN TEAM
SCIENCE AND I ALSO WANTED AS WAS
POINTED OUT BY DR. CLAYTON TO
SAY SPECIFICALLY THANK YOU TO
DR. LISA FROM ORWH AND
DR. SORNSTEIN FROM NIAMS AND THE
RESPECTIVE TEAMS FOR ALL THE
TIRELESS WORK THAT WENT ON IN
MAKING THIS NEW PILOT PROGRAM
HAPPEN.
I APPRECIATE YOUR ATTENTION AND
I'D BE HAPPY TO ADDRESS ANY
QUESTIONS WITH DR. CRISWELL.
>>DR. CRISWELL: I BELIEVE LISA
IS HERE FROM ORWH.
SHE'S ALSO AVAILABLE TO ANSWER
QUESTIONS.
THERE'S SEE IF THERE'S QUESTIONS
ABOUT THE LEADERSHIP SCHOLARS
PROGRAM JUDITH REFERRED TO OR
OTHER ACTIVITIES UNDERWAY ACROSS
ORWH INCLUDING THE OFFICE OF
AUTOIMMUNE DISEASE RESEARCH.
I'M PLEASED THE LEADERSHIP
SCHOLARSHIP PROGRAM WILL BE
CONTINUING AND ANOTHER REQUEST
FOR APPLICATIONS WILL BE OUT
SOON WITH EXPANDED ELIGIBILITY
CRITERIA.
REALLY EXCITED ABOUT THAT AND
EXCITED TO SEE WHAT THE CURRENT
GROUP OF SCHOLARS TO BE
ANNOUNCED SOON HOW TO CONTRIBUTE
AND LEARN FROM THE EXPERIENCE.
LISA, DID YOU WANT TO ADD
ANYTHING ON BEHALF OF
DR. CLAYTON AND ORWH?
>>LISA: I HAVE OTHER COLLEAGUES
ON THE CALL.
DR. TEMPKIN IS AVAILABLE AND
DR. WILEY IS OUR LEAD FROM THE
OFFICE OF AUTOIMMUNE DISEASE
RESEARCH.
THERE'S OVER FOUR OF US AND IF
THERE'S FOLLOW-UP WE'D BE HAPPY
TO WORK WITH YOU FOLKS AS WELL.
I WANT TO INDICATE HOW
APPRECIATIVE WE ARE OF ALL THE
STAFF FROM DIRECTOR DEPUTY
DIRECTOR ON DOWN.
IT'S BEEN A LONG-TERM
PARTNERSHIP BETWEEN ORWH AND
NIAMS BECAUSE OF THE CRITICAL
SCIENTIFIC AREAS THAT AFFECT
WOMEN'S HEALTH BUT THIS IS THE
CULMINATION OF MANY YEARS OF
PARTNERSHIP AND COLLABORATIONS
AND I CANNOT SAY ENOUGH IN TERMS
OF NIAMS PARTICULARLY FOR THE
BIRCH TRANSITION AS
ADMINISTRATIVE I.C. FOR US NOW
AND DR. WILEY CAN COMMENT ON
OADR AND DR. TEMPKIN BUT IT'S
BEEN ACROSS THE BOARD AND
HELPING TO ADVANCE WOMEN'S
HEALTH RESEARCH AND THE CAREERS
OF WOMEN AND MEN IN TERMS OF
WOMEN'S HEALTH RESEARCH.
THANK YOU.
>>
>>DR. CRISWELL: THANK YOU, LISA
AND OTHER COLLEAGUES FOR BEING
HERE.
>>I KNOW IN THE FIRST ROUND THE
APPLICATIONS WERE LIMITED FOR
INDIVIDUALS AT THE ASSOCIATION
PROFESSOR LEVEL AND WONDERING IF
THE CRITERIA IN THE NEXT ROUND
WILL BE EXPANDED SO THAT
ASSISTANT PROFESSORS CAN APPLY
OR FULL PROFESSORS BUT I FEEL
THEY CAN BENEFIT TOO.
>>JUDITH: YOU ARE CORRECT.
WE'RE GOING TO EXPAND.
WE WERE A LITTLE BIT NERVOUS IN
THE NUMBER OF APPLICATIONS WE
WOULD RECEIVE.
WE DID RECEIVE A VERY NICE
TURNOUT BUT I THINK AS WE TALK
TO INVESTIGATORS ABOUT THE
PROGRAM, WE WERE WORRIED IF YOU
WERE A BRAND NEW ASSISTANT
PROFESSOR THERE'S SO MUCH
LEARNING CURVE IN THE FIRST
COUPLE YEARS THAT MAY NOT BE
IDEAL BUT A LOT OF PEOPLE THAT
GET THROUGH THE EARLY YEARS OF
THEIR K MAYBE IN THE LATER STAGE
OF ASSISTANT BUT WE'LL EXPAND
THAT TO CAREER AND EARLY-STAGE
PROFESSORS.
WE WANT TO HELP INVESTIGATORS
COMMITTED TO LEADING TEAM
SCIENCE PROJECTS.
>>THROUGH THE PROCESS OF THE
LEADERSHIP SCHOLAR PROGRAM THEY
WERE A LARGE NUMBER OF CALLS AND
EXCHANGES AND DOCUMENTS.
SO THE AMP AIM NETWORK INCLUDING
DR. JAMES AS THE LEAD FOR US
HAVE BEEN EXTREMELY HELPFUL.
THEY WERE ENTHUSIASTIC FROM DAY
ONE.
THEY OFFERED MEANINGFUL INPUT
AND ADVICE AND SO WE ARE LOOKING
FORWARD TO CONTINUING FOR THE
FIRST GROUP AND AS WE REFERRED
TO IT FOR ROUND TWO.
THIS IS A PLATFORM TO TRAIN YOUR
COMPLEX TEAM LEADERSHIP
>>
>>DR. CRISWELL: SUZANNE.
>>SUZANNE: I WANT TO MENTION AS
ENTITY WORKING CLOSELY WITH
INVESTIGATORS IN THE NIH AND THE
AIM PROGRAM WE HAVE A STEERING
COMMITTEE THAT IS COMPOSED PLANK
-- MANAGED AND EXPOSED BY ALL
THE PARTNERS SUPPORTING AIM AND
THAT IS CO-CHAIRED BY BOB CARTER
HAS ALSO EXTREMELY SUPPORTIVE OF
THE LEADERSHIP SCHOLAR PROGRAM.
VOLUNTEERING NOT ONLY TO
FUNCTION THE MENTORS AND
ADVISORS FOR THE RESEARCH
PROJECT AND SCHOLARS BUT ALSO
PERHAPS TO LEVERAGE SOME
OPPORTUNITIES THAT MAY OCCUR IN
THE INDUSTRY ENVIRONMENT FOR
LEADERSHIP TRAINING TO THE
SCHOLARS.
SO WE HAVE A FEW OPPORTUNITIES
TO WORK WITH OUR COLLEAGUES IN
THAT ENVIRONMENT WHICH IS ALSO A
VERY INTERESTING CAREER
OPPORTUNITY FOR SOME OF THE
CANDIDATES.
BOB, I DON'T KNOW IF YOU WANT TO
ADD TO THAT.
NIH WAS NOT ABLE TO JOIN US BUT
HOPEFULLY WE WILL HAVE MORE
INTERACTIONS AND OPPORTUNITIES
TO HEAR FROM THEM IN THE FUTURE.
>>BOB: WHAT WAS INTERESTING IS
THE INDUSTRY PARTNERS WERE
SUPPORTIVE.
THEY WANTED TO SEE IF THEY CAN
BUILD SOMETHING TOGETHER WHICH
WOULD BE FANTASTIC.
>>DR. CRISWELL: I SEE JINOOS
AND THERE'S A QUESTION IN THE
CHAT FROM MARY BOUXSEIN I CAN
READ NEXT IF MARY'S NOT ABLE TO
TURN ON HER MICROPHONE.
I KNOW SOME FOLKS ARE HAVING
SOME ZOOM PROBLEMS.
JINOOS.
>>JINOOS: A QUESTION QUESTION
ABOUT METRICS OF SUCCESS.
I THINK CERTAINLY INCREASING THE
PIPELINE OF INVESTIGATORS WHO
ARE WOMEN AND STAY IN RESEARCH
AND MAKE CONTRIBUTIONS IS REALLY
IMPORTANT.
I'M WONDERING IF THERE ARE
ADDITIONAL METRICS AROUND ACTUAL
IMPACT ON WOMEN'S HEALTH
OUTCOMES IN THE U.S.
AND GLOBALLY FOR ANY OF THE
PROGRAMS.
>>LISA: ORWH IS BEGINNING AN
INVESTIGATION OF THE BIRCH
PROGRAM WHICH IS THE
INSTITUTIONAL K12 PROGRAM.
WE HAVE HAD PREVIOUS EVALUATIONS
AS WELL IN TERMS OF WOMEN'S
HEALTH RESEARCH IMPACT.
SO THE EXPECTATION IS THAT SINCE
THIS IS A NEW PROGRAM WITH US,
IT WILL BE ROLLED INTO THAT AND
LOOKING AT DEFINING METRICS THAT
CAN BE EVALUATED SUBSEQUENTLY.
IT'S IMPORTANT.
WE DO WANT TO QUANTIFY THE
IMPACT OF THE VARIOUS PROGRAMS
WE HAVE SUSTAINED OVER THE YEARS
SO THANK YOU FOR THAT.
>>DR. CRISWELL: MARY?
>>MARY: I FOLLOWED THIS A
COUPLE YEARS AND I THINK IT'S AN
OUTSTANDING WAY TO LEVERAGE THE
AMP AIM PROGRAM.
I WONDERED IF FOR THOSE
INVESTIGATORS WHO DON'T DO
AUTOIMMUNE DISEASE RESEARCH ARE
WE THINKING OF OTHER SIMILAR
PROGRAMS.
FOR EXAMPLE, LEVERAGING THE
BACPAC PROGRAM A BIG PART OF
NIAMS AT THE MOMENT AND WOMEN
ARE HIGHLY UNDER REPRESENTED IN
ORTHOPEDIC RESEARCH.
IT WOULD BE A REAL OPPORTUNITY
TO TRAIN WOMEN TO DO TEAM
SCIENCE.
THAT'S A HUGE PROGRAM AND
INITIATIVE AS WELL.
I WANTED TO THROW THAT OUT
THERE.
I THINK THERE'S OTHER AREAS OF
NEED OF THIS KIND OF TRAINING
FOR WOMEN SCHOLARS.
>>XENIA: WE'RE LOOKING TO HAVE
MORE PROGRAMS THAT AREN'T
NECESSARILY AUTOIMMUNE DISEASES
BECAUSE THE NEED IS GREAT AND
THERE'S OTHER PROGRAMS THAT NEED
HELP US FROM.
IT'S A PILOT PROGRAM TO SEE
WHETHER WE CAN DO IT APTLY AND
SO GLAD AND HAPPY WE HAVE THE
AMP AIM PLATFORM TO TRY IT OUT.
THEN WE'LL EXPAND AS NEEDED.
WE'RE LOOKING BEYOND.
THANK YOU FOR THAT QUESTION.
>>DR. CRISWELL: I THINK THERE'S
GOING TO BE A FIRST EVER AMP
PROGRAM.
OPEN TO THE BROADER SCIENTIFIC
COMMUNITY FEBRUARY 5 AND 6, IF I
RECALL CORRECTLY ON THE NIH
CAMPUS AND I THINK THAT'S GOING
TO BE A GREAT OPPORTUNITY TO
LEARN ABOUT SOME OF THE
EXPERIENCES IN THAT BIG TEAM
SCIENCE EFFORT THAT OF COURSE WE
HOPE THOSE LESSONS CAN BE
APPLIED IN MANY OTHER DISEASE
AREAS AND COLLABORATIONS AND
NETWORKS.
I DON'T KNOW WHETHER ANY OF YOU
WANT TO SAY A LITTLE BIT MORE
ABOUT THE MEETING.
>>BOB: IT GETS TO JINOOS A
QUESTION.
PART OF THE WHOLE POINT OF THE
MEETING IS IT TO FOCUS ON
IMPACT.
IMPACT UP A BROADER SENSE WHEN
WE DO THESE TYPES OF
INITIATIVES, WHO DO THEY IMPACT.
OBVIOUSLY RESEARCHERS AND IN THE
CASE OF AMP, WE WANT TO GET TO
HOW DOES INDUSTRY TAKE THAT
INFORMATION AND ACTUALLY, I
THINK IF ANYTHING THE BIGGEST
REAL WORLD IMPACT OF SOMETHING
LIKE AMP THE DECISIONS MADE BY
INDUSTRY IS WHETHER TO PURSUE A
DRUG TARGET OR NOT.
ALSO, OBVIOUSLY, PATIENT
ADVOCATES AND TEO IS HERE AND
MARY COLLINS IS A CO-CHAIR OF A
STEERING COMMITTEE FOR AMP AIM.
WE'RE LOOKING FOR THAT ANGLE.
AMP, MOST OF IT IS FAIRLY BASIC
INVOLVING TARGETED IMPLICATION
AT A BASIC LEVEL OF IDENTIFYING
A NEW TARGET.
IT'S DISTANT FROM THE CLINIC BUT
I HOPE THE SENSE OF HOPE COMES
THROUGH TO SOME OF THE PATIENT
COMMUNITIES THAT THIS IS A
DIFFERENT WAY OF DOING RESEARCH
AND REALLY OFFERS A LOT OF HOPE
AND NEW TARGETS AND NEW WAYS OF
TREATING DISEASES OR NOT DOING
CLINICAL TRIALS FOR TARGETS NOT
WORTH WHILE.
I DO THINK THAT IMPACT QUESTION
GETS TO THE EARLIER QUESTION OF
WHAT'S THE BIG PICTURE HERE AND
I THINK IN AMP THERE'S A REAL
OPPORTUNITY TO SEE THAT.
THANKS.
>>DR. CRISWELL: ANY MORE
QUESTION FOR JUDITH OR ORWH
COLLEAGUES OR WE WOULD WELCOME
IF ANY OF YOU FROM ORWH OR
JUDITH WANT TO ADD TO THE
DISCUSSION OTHER POINTS THAT
HAVE COME TO MIND YOU THINK MAY
BE OF INTEREST TO THE NIAMS
COUNCIL AND BROADER COMMUNITY
LISTENING?
>>I WANTED TO POINT OUT THE
WEBSITE RIGHT NOW IS
AMPAIM.NRF.org AND HAS THE
FUNDING OPPORTUNITY AND THE NEW
RFA WILL BE POSTED THERE AS
WELL.
>>DR. CRISWELL: WELL, IF THERE
AREN'T ANY OTHER QUESTIONS I
WANT TO JANINE AND WE'LL PASS
ALONG OUR GRATITUDE FOR HER
PRESENTATION AND LISA AND
COLLEAGUES FROM ORWH, THANK YOU
SO MUCH FOR BEING HERE AND
JUDITH THANK YOU FOR ALL YOU'RE
DOING TO SUPPORT AMP AIM AND THE
COUNCIL.
THANK YOU ALL.
SO THAT WILL BRING US TO THE END
OF THIS SECTION OF THE MEETING.
I'M LOOKING OVER TO DARREN.
WHAT DO YOU THINK?
SHOULD WE GO STRAIGHT -- OKAY.
STUART AND JOAN.
HOW ABOUT IF WE MOVE TO THE NEXT
AGENDA ITEM.
FOR THE NEXT PRESENTATION I'M
DELIGHTED TO INTRODUCE
DR. STUART GOODMAN ON OUR
COUNCIL AND WITH US TODAY AND
DR. JOAN BATHON A PAST COUNCIL
MEMBER WHO CO-CHAIRED AN EFFORT
WE'VE BEEN EXCITED ABOUT FOR A
NUMBER OF YEARS AND GRATEFUL
THEY'VE BEEN WILLING TO TAKE ON
A ROLE FOR THAT GROUP AND
PROVIDE AN OVERVIEW AND UPDATE
FROM THAT CLINICAL TRIALS
WORKING GROUP.
THIS IS BE AN INTERIM REPORT.
NOW STUART AND JOAN FOR NEXT
PRESENTATION.
>>AS
>>STUART: THIS IS A REPORT ON
THE CLINICAL TRIALS WORKING
GROUP.
SO THE CHARGE IS FORMAL.
AND IT IS AS FOLLOWS, TO
CONSIDER HOW NIAMS COULD
OPTIMALLY SOLICIT AND FUND
APPLICATIONS FOR CLINICAL TRIALS
HAVE THE GREATEST IMPACT IN
IMPROVING CLINICAL OUTCOMES
WHETHER OF RARE OR COMMON
DISEASES.
TO FOCUS ON IMPROVING THE
PREVENTION, DIAGNOSIS AND/OR
TREATMENT OF PEOPLE WITH THE
DISEASES AND CONDITIONS IN THE
NIAMS MISSION AREA.
SO ON BEHALF OF DR. JOAN BATHON
AND MYSELF, WE WOULD LIKE TO
GIVE OUR GREAT THANKS TO THE
COMMITTEE MEMBERS WHICH ARE
LISTED HERE AND ESPECIALLY TO
THE NIAMS FACILITATORS LISTED ON
THE BOTTOM LEVEL.
WE ALSO ENGAGED IN VERY
EXTENSIVE CONSULTATIONS WITH
THREE OTHER INSTITUTES AND
THEY'RE LISTED ON THIS SLIDE.
NCCIH, NIDCR AND NHLBI.
WE HAD EXTENSIVE PRESENTATIONS
BY THESE INSTITUTES AND WE ASKED
THEM A LOT OF QUESTIONS TO TRY
AND SEE HOW THINGS ARE DONE IN
THEIR INSTITUTES WITH REGARDS TO
SIMILAR PROGRAMS THAT WE'RE
CONSIDERING.
SO HERE ARE OUR TWO INTERIM
RECOMMENDATIONS TO COUNCIL.
HOW MIGHT NIAMS STRUCTURE
PROGRAMS TO LEAD TO IMPACTFUL
TRIALS?
FIRST, NIAMS SHOULD CONSIDER
DIFFERENT OPTIONS FOR SMALLER,
EXPLORATORY AND PRELIMINARY
FEASIBLE MECHANISMS WITH LARGER
BUDGET AND TIME FRAME ALLOWED.
SECOND, NIAMS SHOULD CONSIDER A
TWO-PHASED AWARDS PROCESS WITH
UG3/UH3 MECHANISMS FOR LARGE
CLINICAL TRIALS APPLICATIONS.
SO, HERE'S SOME MORE DETAILS,
FIRST, NIAMS SHOULD CONSIDER
DIFFERENCE OPTIONS FOR TRIAL
MECHANISMS WITH A LARGER BUDGET
AND THE R21 IS A THREE-YEAR,
$400,000 DIRECT CAPPED COSTS AND
WE HAVE RECOMMENDED MORE
FLEXIBILITY IN TIME, BUDGET AND
PAGE LENGTH LIMIT AND THIRD
CONSIDER THE R61 MECHANISM THAT
ALLOWS THREE TO FIVE YEARS
UNCAPPED BUDGET AND 12 PAGE
RESEARCH STRATEGY, ETCETERA.
WE RECOGNIZE THE TRADE-OFF COULD
BE FEWER CLINICAL TRIALS
SUPPORTED IF WE INCREASE THE
BUDGET.
SOW THE RATIONALE IS THE MAIN
DIFFICULTY IN THE BUDGET AND THE
THREE-YEAR TIME FRAME IS RATHER
RESTRICTING.
ONLY A VERY SMALL PILOT STUDY
COULD BE CONDUCTED WITH SUCH
FUNDING.
GIVEN THE LOW R21 CAPPED BUDGET,
SUBMISSIONS CANNOT BE MADE
TOWARDS AN INDA TYPE TRIAL.
IN THE CURRENT UL 1 IS FOR MORE
THAT TURE STUDIES OR ISSUES TO
BE EXAMINED.
NIAMS SHOULD CONSIDER
ESTABLISHING A TWO-PHASE,
MILESTONE-BASED PROCESS WITH
UG3, UH3 MECHANISMS FOR CLINICAL
TRIAL APPLICATIONS.
HERE ARE EXPLANATION.
THIS WILL ALLOW FLEXIBILITY TO
ADJUST THE TIMING ASSOCIATED
WITH EACH PHASE.
FOR EXAMPLE, THE UG3 PHASE CAN
VARY FROM NINE TO 18 MONTHS AND
UH3 FROM THREE TO SIX YEARS.
SKPD, ESTABLISH CLEAR GO, NO-GO
MILESTONES FOR TRANSITION TO THE
UH3 PHASE.
THIRD, ESTABLISH CLEAR SUCCESS
MILESTONES FOR UH3 PHASE SO ONE
COULD TRACK AND MANAGE THE
PROGRESS OF THE GRANT.
FOURTH, LEVERAGE COOPERATIVE
AGREEMENT STRUCTURES WHEN
POSSIBLE THIS MIGHT BE WITH
OTHER INSTITUTIONS OR EVEN
OUTSIDE OF NIH.
FIVE, ESTABLISH IND APPROVAL
TIMING AND CONSIDER HOW TO COVER
THESE COSTS.
AND SIXTH, NIAMS SHOULD
DETERMINE HOW LONG TO MAINTAIN
AND REPURPOSE THE R34 AND UL 1
MECHANISMS.
SO THE RATIONALE WAS THESE ARE
PROVEN PROCESSES AND MECHANISMS
USED BY OTHER INSTITUTES THAT WE
ENGAGED AND TALKED TO IN DETAIL.
THE STRUCTURE ACCELERATES THE
TIME LINE WHILE MAINTAINING
MOMENTUM BETWEEN THE PLANNING
AND IMPLEMENTATION PHASES.
MANY ON THE COMMITTEE FELT THERE
WAS A LAG TIME BETWEEN THE
PLANNING AND IMPLEMENTING OF
THIS THEIR PARTICULAR CLINICAL
GRANTS AND THIS WAS
DISHEARTENING AND MOMENTUM WAS
SOMETIMES LOST.
SO WHAT'S NEXT?
WE'RE GOING TO FOCUS MAINLY ON
IMPACT.
FIRST, WHAT TYPES OF STUDIES
WILL HAVE THE GREATEST IMPACT ON
PEOPLE'S LIVES?
SECOND, WHAT SHOULD NIAMS
SOLICIT OR SHOULD NIAMS SOLICIT
TOPICS TO PRIORITIZE FROM THE
EXTRAMURAL COMMUNITY.
AND THIRD, WHAT IS THE NIAMS
NICHE IN THE CONTEXT OF THE
BROADER CLINICAL TRIALS
LANDSCAPE.
SO WITH REGARDS TO INVESTIGATOR
OR COMMUNITY ENGAGEMENT, HOW CAN
NIAMS BETTER SUPPORT APPLICANTS.
THIS WAS NEAR AND DEAR TO ALL OF
US ESPECIALLY THE NIH STAFF.
FINALLY THE TRIALS BUDGET SIZE
TRADE-OFFS WHAT'S THE
APPROPRIATE BUDGET CEILING AND
SHOULD NIAMS SUPPORT FEWER
TRIALS WITH LARGER BUDGETS OR
CONTINUE TO SUPPORT A BROADER
MIX OF TRIALS.
THESE ARE ALL COMPLEX,
CONTROVERSIAL ISSUES WE HOPE TO
TACKLE OVER THE NEXT NUMBER OF
MONTHS.
AND IT'S PRESENTING INTERIM
RECOMMENDATIONS TO THE COUNCIL
AND PUBLIC AND WE HOPE THAT OUR
FINAL RECOMMENDATIONS WILL BE
AVAILABLE TO REPORT TO COUNCIL
SOME TIME IN THE NEW YEAR.
THANK YOU VERY MUCH AND I WOULD
LIKE, JOAN, IF YOU WOULD LIKE TO
MAKE FURTHER COMMENTS OR ANY
OTHER MEMBERS OF THE COMMITTEE
PLEASE FEEL FREE TO SPEAK UP.
>>JOAN: YOU DID A GREAT JOB.
I WOULD JUST ADD THE UG3, UH3
THEY DON'T HAVE TO GO OVER THE
PEER REVIEW FROM THE CLINICAL
PHASE TO THE PLANNING PHASE
WHICH IS A HUGE ADVANTAGE.
>>DR. CRISWELL: THANK YOU FOR
THAT UPDATE.
I'M SO EXCITED TO HAVE OF YOU
GREAT MINDS THINKING ABOUT THESE
IMPORTANT ISSUES AND THE TIME
YOU'VE TAKEN TO LEVERAGE
LESSONED LEARNS FROM OTHER
INSTITUTES AND CENTERS.
I WANT TO MAKE SURE FOLKS ARE
AVAILABLE THAT MARIA
SUAREZ-ALMAZOR IS ON THE COUNCIL
AND BOB CARTER.
AN OPPORTUNITY FOR ANY INVOLVED
TO RAISE QUESTIONS, ETCETERA.
>>LUIS
>>THANK YOU FOR PRESENTING YOUR
RESULTS AND THANK YOU FOR
ADDRESSING THIS DIFFICULT
QUESTION BECAUSE I FEEL LIKE
TRIALS CAN BECOME SO EXPENSIVE
AND CAN BE NEGATIVE AND IT'S A
BIG RISK IN A LOT OF CASES.
CLEARLY IT'S SO IMPORTANT
BECAUSE THERE'S A LOT OF TRIALS
COMPANIES DON'T WANT TO DO AND
IN THE END A LOT OF THE NIAMS
PATIENTS WE SERVE NEED THE DATA.
I SEE IT'S BETWEEN A ROCK AND
HARD PLACE.
ALSO, I FEEL THE TRAINING
OPPORTUNITIES IN AND CAREER
DEVELOPMENT OPPORTUNITIES ARE
SLIGHTLY LOWER.
WITH A LONG TRIAL WHO IS GOING
TO BE FIRST AUTHOR AND BE ABLE
TO LAUNCH THEIR CAREER.
SOMETIMES THERE'S HARD QUESTION
S INDUSTRY WILL BE THE LARGEST
MORE AND LARGE TRIALS ARE
IMPOSSIBLE FOR NIH TO DO.
WHAT'S THE SWEET SPOT TO TEE UP
FOR THE PHARMACEUTICAL INDUSTRY?
>>STUART: THERE WERE TREMENDOUS
OPPORTUNITIES WITH OTHER
INSTITUTES AND WITH INDUSTRY TO
TRY AND GET THE COMPLICATED
TRIALS FUNDED AND CARRIED OUT.
I'LL ASK JOAN AND OTHERS ON THE
COMMITTEE INCLUDING THE NIH
PEOPLE IF THEY HAVE OTHER
COMMENTS.
>>JOAN: WE'RE LOOKING MORE TO
US DOING IMPORTANT CLINICAL
TRIALS OPPOSED TO HANDING IT OFF
TO INDUSTRY.
YOU COULD ARGUE THE MECHANISM
WASN'T SUFFICIENT FOR ANIMAL
STUDIES AND DO A PRELIMINARY
EARLY STUDY IN HUMANS TO THEN
SUCCESSFULLY APPLY FOR AN UR 1
BY SEPARATING THE PLANNING PHASE
FOR AN ACTUAL CLINICAL TRIAL.
YOU CAN USE THE OTHER MECHANISMS
TO DO TRANSLATIONAL STUDIES OR
IN VITRO STUDIES TO PREPARE FOR
A LARGER PHARMACEUTICALLY BASED
APPLICATION.
>>RENUKA: YOU SAID OTHER
INSTITUTES IMPLEMENTED SOME OF
THESE CHANGES.
I WONDER IF THERE'S INFORMATION
FROM THOSE INSTITUTES ABOUT
SHINING SUCCESSES THAT CAME OUT
OF THE CHANGES AND/OR LIKE
UNANTICIPATED OUTCOMES THAT WERE
NOT IDEAL?
DID YOU GET ANY INFORMATION?
I DON'T KNOW IF SOMEONE IN THE
ROOM HAS INFORMATION ABOUT THAT.
>>I CAN TELL YOU MY PERSONAL
IMPRESSIONS AND THEN I WILL
INVITE JOAN AND OTHERS ON THE
COMMITTEE INCLUDING THE NIH
PERSONNEL TO COMMENT.
THEY FELT IT WAS A TREMENDOUS
SUCCESS.
THEY FELT THAT THE GRANTS BECAME
MORE FOCUS SED THERE WAS A CLOS
RELATIONSHIP DEVELOPED BETWEEN
THE NIH PERSONNEL AND P.I.s AND
THEY WERE BASICALLY KEPT ON
TRACK TO A HIGHER LEVEL RATHER
THAN PERHAPS LET THINGS DWINDLE
SOMETIMES WHEN PROBLEMS ARISE
AND WITH THE NEW MECHANISMS THEY
FELT THERE WAS MUCH MORE
ENGAGEMENT AND CLOSE SUPERVISION
AND CROSS TALK.
>>LISA: WE MAY HAVE GOTTEN A
BIASSED VIEW.
LIKE STUART SAID THE STAFF OF
THE INSTITUTES SAID THE
INVESTIGATORS WERE OVER ALL
EXTREMELY HAPPY WITH THE
TRANSITION AND HAD BEEN IN PLACE
10 YEARS EVEN.
IT WAS NOT A NEW THING.
>>BOB: THERE WERE LESSONS
LEARNED.
ONE WAS THE TIMING OF THE
TRANSITION.
WE HEARD PROS AND CONS THERE.
BUT THIS IS CLEAR IT WAS A
PROBLEM FOR SOME FOLKS.
WE MAY BE MORE FLEXIBLE.
THERE WERE SOME THINGS WE
LEARNED FROM BESIDES JUST
ENCOURAGEMENT.
>>LISA: THERE WAS MORE HANDS ON
MANAGEMENT IN THE CLINICAL TRIAL
PHASE FOR SURE.
SOME MAY HAVE BEEN PUT OFF BY
THAT.
>>STUART: OUT WE MORE FROM MY
POINT OF VIEW A PARTNERSHIP THAN
JUST HANDING OUT THE MONEY AND
SAYING GO AHEAD AND PERFORM THE
CLINICAL TRIAL.
MORE CROSS TALK I THINK.
>>DR. CRISWELL: MARY AND
SUZANNE AND VALENTINA PUT A
COMMENT IN THE CHAT.
HE'S -- SHE'S HAVING A PROBLEM
WITH HER VOICE TODAY.
>>MARY: MY QUESTION HAS TO DO
WITH THE BUDGET IMPLICATIONS OF
CHANGING OR DROPPING THE R21 AND
MOVING TO THE OTHER MECHANISMS
AND IT DOESN'T MEAN MORE
EXTENSIVE TRIALS HOW'S IT FIT IN
THE MIX COMPARED TO WHAT WE'RE
USED TO SEEING AT NIAMS AND
THINK OF HOW TO GO FORWARD?
>>STUART: I'LL DEFLECT TO BOB
AND CHUCK.
>>BOB: THE R61 CAN BE USED AS A
SINGLE PHASE AND USED TO BE
THOUGHTS S S OF A TWO-PHASE BE
QUESTION REMAINS AS WITH THE
CURRENT SYSTEM WHICH IS WHAT'S
THE RIGHT AMOUNT TO PUT IN
CLINICAL TRIALS, PERIOD.
HISTORICALLY WE'VE BEEN ON THE
LOW END BUT THE SUCCESS RATE IS
PRETTY HIGH FOR US.
IF WE THINK IT'S IMPORTANT WE
GRANT AND GO FOR IT.
IF YOU'RE GOING TO BE STRICTLY
BY THE GROUP TO THE R61 WILL
MEAN FEWER CLINICAL TRIALS
BECAUSE THEY HAVE A SLIGHTLY
LOWER BUDGET THAN THE R21 BUT I
THINK EVERYONE IS EXPECTING THE
BUDGET AND PAGE LIMIT
RESTRICTIONS ON THE R21 WAS AN
IMPEDIMENT TO THE SCIENCE AND
WE'D BE BETTER OFF SPENDING A
BIT MORE PERHAPS WITH A BIT
FEWER NUMBER OF AWARDS TO GET A
BETTER OUTCOME.
>>ANYTHING TO ADD?
>>BOB SAID IT PERFECT.
>>SUZANNE: ON THE TRANSITION
FROM THE PLANNING TO THE
EXECUTION PHASE OF THE CLINICAL
TRIAL NOT REQUIRING ANOTHER
SUBMISSION AND THERE'S ABILITY
FOR THE EXPLORATORY STUDIES.
I HAVE A QUESTION.
DID ANY INSTITUTES THAT PUT IN
PLACE THESE CHANGES LOOK AT THE
IMPACT OF THE CLINICAL TRIALS?
WE KNOW MANY OF THE MEASURES
THAT ARE SUGGESTED OR DESCRIBE
LEAD TO SUCCESSFUL COMPLETION OF
THE CLINICAL TRIALS WHICH BY
ITSELF IS TERRIFIC.
DID THEY FEEL THE OUTCOMES
SELECT
SELECTED WERE BEST OR A SYSTEM
TO EVALUATE THE CHANGES THEY
MADE?
THE SECOND IS IS THERE ANY
DISCUSSION ON THE VALUE ON
TRANSLATIONAL RESEARCH EFFORT OR
THE TRANSLATIONAL PIECE THAT CAN
AUGMENT THE VALUE OF THAT
EXPERIENCE?
WE OFTEN STRUGGLE WITH HOW MUCH
OF A TRANSLATIONAL COMPONENT WE
CAN ALLOW AND SUPPORT IN THE
CONTEXT OF THE CLINICAL TRIALS.
IT'S BEEN A BIT OF A DILEMMA FOR
A WHILE.
>>JOAN: THE TRANSLATIONAL
ASPECTS WERE SEPARATED AND ONE
THING THAT CAME UP REPEATEDLY IS
TO SUCCESSFULLY ENGAGE IN THE
UG3 MECHANISM FOR CLINICAL
TRIALS IF IT'S POTENTIALLY
PHARMACEUTICALLY SPONSORABLE YOU
NEED YOUR I.N.D. IN PLACE
BEFORE.
YOU HAVE TO BE READY TO ROLL
WITH YOUR I.N.D. AND ALMOST IRB
APPROVAL.
A LOT OF PRELIMINARY WORK NEEDS
TO BE DONE SO THE TRANSLATIONAL
WORK NEEDS TO BE FINISHED
THROUGH THE MECHANISM.
AND OUTCOMES, I THINK WE ASKED
THEM THAT.
I DON'T RECALL DIRECTOR OUTCOME
MEASUREMENTS.
>>STUART: THE QUESTION
DISCUSSED AND RAISED AND WE'LL
DISCUSS IT OVER THE NEXT SIX
MONTHS HOW DO YOU MEASURE
IMPACT?
DO YOU MEASURE IT BY COMPLETION
OF THE STUDY.
DO YOU MEASURE IT BY
PUBLICATIONS?
DO YOU MEASURE IT BY CHANGING
THE PARADIGM IN SOCIETY?
IT'S A COMPLICATED ISSUE BUT WE
WERE PRESENTED WITH DATA THAT
SHOWED IMPACT WITH REGARDS TO
COMPLETION OF STUDIES ALSO
GRANTS LIKE THE R34 THAT WENT ON
TO A MORE COMPREHENSIVE GRANT
AND WHETHER SOME OF THE SMALLER
GRANTS PROGRESSED TO OTHER
GRANTS NOT ONLY WITHIN OUTSIDE
OF NIAMS IN NIH AND OUTSIDE OF
NIH.
IT'S A TOPIC WE HAVE SOME PSEUDO
MEASURES FOR BUT I THINK IT'S
GOING TO TAKE A LOT OF
DISCUSSION TO FIGURE OUT WHAT WE
MEAN BY IMPACT.
>>CAN I JUMP IN QUICKLY.
THE NUMBER OF R34s WAS STRIKING.
30% OR SOMETHING LIKE THAT.
>>THEY WENT ON TO FUNDING
ELSEWHERE SO WHILE THE TRIAL
WASN'T SUPPORTED BY NIAMS
ULTIMATELY IT WAS SUPPORTED BY
THE DOD FOR EXAMPLE.
ONE THAT WAS THEIR ULTIMATE
GOAL.
>>THAT'S SOMETHING WE'LL NEED
TO DISCUSS INTERNALLY.
>>I SEE TEO AND MAYBE WE'LL
MAKE THIS THE LAST QUESTION FOR
THE SESSION TO HAVE TIME FOR
CONCEPT CLEARANCE.
TEO DO YOU WANT TO ASK YOUR
QUESTION?
>>TEO: I HAD A COUPLE QUESTIONS
AND COMMENTS AND I HOPE THEY'RE
APPROPRIATE.
I WAS WONDERING IF THE WORKING
GROUP HAS GIVEN CONSIDERATION TO
EMPHASIZING BASKET TRIALS TO
MAXIMIZE THE LEARNING AND
RESOURCES AND THERE WERE
EXAMPLES OF COLLABORATIONS
BETWEEN NIAMS WITH OTHER
INSTITUTE AND WONDERING IF THIS
WOULD BE PER SUED THROUGH THESE
MECHANISM TO LEVERAGE RECEIVERS
AND GET THE NIAMS DOLLAR
FURTHER.
ONE QUESTION OPPOSED WAS SHOULD
NIAMS SOLICIT INPUT.
I WANTED TO MENTION AS SOMEONE
WORKING FOR A PATIENT-FOCUSSED
ORGANIZATION, IT MAY BE
IMPORTANT TO SOLICIT THE INPUT
FROM THE PATIENTS IN TERMS OF
WHAT KINDS OF STUDIES ARE MOST
IMPACTFUL AND RELEVANT TO THEM.
PATIENTS WANT TO SEE MORE
STUDIES ABOUT THE IMPACT OF DIET
AND STRESS AND IMPACT OF
EXERCISE AND OTHER LIFESTYLE
FACTORS THEY ANECDOTALLY FIND
IMPACTFUL TO THE DISEASES AND
INDUSTRY WON'T DO THAT BECAUSE
IT'S NOT WITHIN THEIR PURVIEW.
THAT LEADS TO MY LAST POINT IN
THAT WHILE I DO AGREE WITH THE
EARLIER COMMENTS IT'S IMPORTANT
TO FIND A PIPELINE TO INDUSTRY
THROUGH THE PROGRAM I THINK IT'S
ALSO IMPORTANT TO THINK ABOUT
THE ALTERNATIVE PATHWAY AND
THAT'S THE STUDIES THAT INDUSTRY
WILL NOT BE INTERESTED IN AND IS
NOT WITHIN THEIR PURVIEW.
THINKING OF REPURPOSING DRUGS OR
COMPLIMENTARY APPROACHES.
THANK YOU.
>>STUART: SOME OF THESE POINTS
WE ENCOURAGED BETWEEN NIAMS AND
OTHER ORGANIZATIONS.
WITH REGARDS TO INPUT FROM OTHER
ORGANIZATIONS AND PATIENTS,
ETCETERA, THAT'S FOR THE NEXT
THREE OR FOUR MONTHS AND I THINK
MOST OF US ARE ON BOARD WITH
YOUR COMMENTS AND WE REALLY
APPRECIATE THOSE.
>>DR. CRISWELL: YES, THANK YOU
SO MUCH.
AND WITH RESPECT TO THE TWO
INTERIM RECOMMENDATIONS I WANT
TO EMPHASIZE A BIG CONCERN OF
MINE HAS BEEN AND WILL CONTINUE
TO BE BURDEN ON INVESTIGATORS
AND ON THE SYSTEM.
THE RECOMMENDATION RELATED TO
THE PHASED AWARD IS APPEALING
AND I'M THANKFUL OTHERS FOUND IT
TO BE A SUCCESSFUL APPROACH.
THANK YOU ALL VERY MUCH.
REALLY LOOKING FORWARD TO PART
TWO.
I THINK WE'RE PLANNING AN UPDATE
PERHAPS A FINAL UPDATE AT OUR
JANUARY COUNCIL MEETING.
LOOKING FORWARD TO THAT AND
THANK YOU AGAIN FOR THE
PRESENTATION TODAY AND THE
DISCUSSION.
AND ON THAT NOTE I'LL TURN IT
OVER TO DARREN AGAIN NOW.
>>DARREN: THANK YOU VERY MUCH.
WE HAVE A CONCEPT CLEARANCE
PRESENTATION BEFORE WE JUMP
RIGHT TO THAT I WANTED TO SAY A
FEW WORDS ABOUT THE CONCEPT
CLEARANCE PROCESS HERE AND HOW
WE USE IT AT NIH.
SO AT NIH WE NEED TO RECEIVE
PUBLIC ADVICE ON THE MERITS OF
THE POTENTIAL APPLICATIONS AND
DESCRIBE THE PURPOSE, SCOPE AND
OBJECTIVES OF ANY PROPOSED
INITIATIVES.
THESE ALSO REPRESENT VERY EARLY
PLANNING STAGES WHICH COULD TURN
INTO NOTICES OF FUNDING
OPPORTUNITIES OR PROGRAM
ANNOUNCEMENTS AND SPECIAL
INTEREST, ETCETERA.
AND TO DOCUMENT THAT COUNCIL HAS
CLEARED AN INITIATIVE FOR
FURTHER DEVELOPMENT WHEN WE'RE
DONE WITH THE DISCUSSION AND THE
TALK WE'RE GOING TO HOLD A VOTE
AFTER THE PRESENTATION.
SO WITH THAT I'LL TURN IT OVER
TO GAYLE LESTER THE DIRECTOR OF
EXTRAMURAL RESEARCH AND WILL
LEAD THE DISCUSSION ON THE
CONCEPT ON RESEARCH INTEREST AND
LOOK FOR INPUT FROM COUNCIL.
IF WE CAN THAT OUT AND WE'LL GO
TO GAYLE.
>>THANK YOU ALL.
>>GAYLE: I WANT TO GO THROUGH A
FEW SLIDES TO EXPLAIN WHAT WE'RE
PROPOSING FOR THE CONCEPT.
THIS IS ENTITLED INTEGRATED
RESEARCH ON MECHANISMS OF
MUSCULOSKELETAL PAIN.
PART OF THE PURPOSE IS TO
ADVANTAGE OF THE FUNDING FOR THE
HEAL INITIATIVE, THE HELPING TO
END ADDICTION LONG TERM FUNDING
THE NIH HAS RECEIVED OVER THE
LAST 10 YEARS.
IT'S BEEN VERY BENEFICIAL THE
LAST EIGHT YEARS I GUESS MAYBE
NOT QUITE THAT LONG.
IT'S BEEN VERY BENEFICIAL TO
RESEARCH IN SOME AREAS OF
INTEREST TO NIAMS RELATED TO
PAIN AND LOW BACK PAIN AND PAIN
IN GENERAL.
THE CONCEPT IS TO ADDRESS THE
MUSCULOSKELETAL PAIN AS
INTEGRATED PROCESSES WITH
CERTAIN SHARED FUNCTIONS.
THESE ARE RATHER GENERAL
PROPOSALS OF WHAT WE WOULD HOPE
TO ADDRESS WITH WHATEVER
INITIATIVE WE WOULD PUT OUT.
THE CURRENT INITIATIVES THAT ARE
FUNDED AT THE PRESENT TIME AND
I'LL GO INTO SOME OF THEM IN A
MINUTE OR TWO THE NEXT SLIDE,
WILL BE MANAGED AS PART OF THIS
INTEGRATED PROGRAM THAT WE WOULD
BE PROPOSING TO DO.
AND THE FUTURE INITIATIVES, THE
NEWER ADDITIONS WOULD BE
FORMULATED THROUGH PROGRAMMATIC
INPUT AND INSIGHTS TO ADDRESS
GAPS IN KNOWLEDGE AND IDENTIFY
NOVEL RESEARCH DIRECTIONS FOR
PAIN RESEARCH.
SO JUST TO REFRESH YOUR MEMORY,
WHERE WE ARE NOW WITH THE
COLLABORATION AND COORDINATION
WITH HEAL PROGRAMS, CAN PEOPLE
HEAR ME BECAUSE IT SEEMS LIKE
I'M GOING IN AND OUT WHEN I MOVE
MY HEAD -- HERE, WE HAVE A
LITTLE DIAGRAM SHOWING SOME OF
THE DIFFERENT ASPECTS OF HEAL
PROGRAMS AT NIH.
THE TWO, THE RIGHT AND LEFT
BACPAC AND REJOIN ARE FOCUSSED
AT NIAMS AND INVOLVE LOW BACK
PAIN AND THE REJOIN IS
INNERVATION AND UNDERSTANDING
PERIPHERAL AND CENTRAL PAIN
MECHANISMS.
THE OTHER ASPECTS -- OTHER THREE
BULLETS REPRESENT THE PRECISION
NETWORK WHICH COMES FROM NICHD
AND THE INITIATIVE SUPPORTED
PREDOMINANTLY FROM NICHD AND
THEN THE PAIN SIGNATURES AND
BIOMARKERS ARE ALSO FROM THE
NINDS.
SO THESE ARE ALL CLOSELY RELATED
IN CONCEPTS AND IN GOALS AND THE
NEXT SLIDE WILL SHOW YOU SOME OF
WHAT WE CALL THE HEAL RESEARCH
ECO SYSTEM WHERE YOU CAN SEE THE
RELATIONSHIPS BETWEEN THE
DIFFERENT ASPECTS OF PAIN AND
DISEASE INCLUDING ENVIRONMENT,
MICROB
MICROBIOME, BEHAVIORAL,
PSYCHOSOCIAL ASPECTS, COMPONENTS
CAPTURED BY THOSE PROGRAMS AND
BY WHATEVER PROGRAMS WE WOULD
PUT FORWARD THAT WOULD SEEK TO
FURTHER THIS RESEARCH AND THOSE
PARTICULAR AREAS.
THE NEXT SLIDE IS SHOWING YOU A
LITTLE TIMETABLE.
SO YOU CAN SEE BACPAC WHICH IS
CURRENTLY UNDERWAY, MYOFASCIAL
PAIN AND PRECISION.
THE GREEN WOULD BE THE NEW
PROJECTS THAT WE WOULD BE
PROPOSING TO DO IN 2025 THROUGH
2030 WHICH IS KIND OF SCARY TO
THINK ABOUT.
YOU CAN GET A PRETTY GOOD IDEA
OF HOW WE WOULD BE LEARNING FROM
WHAT'S BEEN DONE AS BEING DONE
AND BEING COMPLETED AND
INTEGRATING OUR UNDERSTANDING OF
MUSCULOSKELETAL PAIN BASED ON
THE OUTCOMES FROM THESE PROJECTS
AND FURTHER RESEARCH THAT WOULD
DELVE INTO EVOLVING AREAS AND
MORE COMPLEX METHODOLOGIC
APPROACHES.
I'LL BE GLAD TO ANSWER ANY
QUESTIONS.
DARREN.
>>DARREN: I WAS GOING TO GIVE
EVERYBODY SOME MOMENTS TO THINK
OF QUESTIONS.
>>DR. CRISWELL: SO NOW'S A GOOD
TIME IF YOU'RE UNSURE FEEL FREE
TO SPEAK UP.
>>TEO: I'M UNSURE.
>>WE WANT A CHANCE FOR PUBLIC
INPUT AND QUESTIONS AND THINGS
TO CONSIDER PROVIDING ADVICE.
AND THEN ASSUMING COUNCIL AGREES
GOING FORWARD WITH THIS AFTER WE
DO THE VOTE WE START DEVELOPING
SPECIFIC NOTICES OR AREAS OF
RESEARCH OR DECIDING HOW WE WANT
TO PURSUE THIS.
SO IT IS KIND OF A BROAD AND
GENERAL CONCEPT THAT WE JUST
WANT YOUR FEEDBACK ON BASICALLY.
>>DR. CRISWELL: I THINK IT'S
REQUIREMENT, RIGHT?
>>IT IS A REQUIREMENT WE GET
PUBLIC INPUT.
WE DO GO TO COUNCIL FOR IT
BECAUSE IN MANY WAYS IT'S THE
EASIEST WAY TO DO BECAUSE IT'S
FOR THIS PUBLIC AND WE CAN GET
FEEDBACK FROM THE PUBLIC AFTER
COUNCIL.
>>JOAN: WE DON'T ALWAYS KNOW
THE OPPORTUNITIES AND IF WE HAVE
A GENERAL CLEARANCE FOR THESE
TYPES OF ACTIVITIES IT WOULD BE
WITHIN THE BOUNDARIES OF WHAT WE
PRESENTED TO YOU.
THEN WE'RE ABLE TO TAKE
ADVANTAGE OF THE OPPORTUNITIES
AS THEY ARISE AND NOT HAVE TO
COME BACK TO COUNCIL FOR THE
FIVE-YEAR PERIOD THAT THE
CONCEPT CLEARANCE IS GRANTED.
>>STUART: THIS COVERS US FOR
FIVE YEARS AND DON'T KNOW THE
OPPORTUNITIES IN A COUPLE YEARS
WE TRY TO PLAN THEM AHEAD OF
TIME.
DOES THAT HELP?
>>I WANTED TO UNDERSTAND THE
RELATIONSHIP BETWEEN THIS
CONCEPT CLEARANCE AS AN IDEA AND
SIMILARLY THEMED INITIATIVES
THAT HAVE BEEN DONE.
LIKE THE SUPPLEMENT PROGRAMS WE
SPOKE ABOUT EARLIER.
>>STUART: FOR INSTANCE, WE
HEARD ABOUT THE CLINICAL TRIAL
WORKING GROUP AND OUR PLAN IS TO
HEAR A FULLER REPORT IN JANUARY
AND HAVE A CONCEPT CLEARANCE AT
THE COUNCIL TO TALK ABOUT HOW
WE'RE GOING TO MOVE FORWARD TO
IMPLEMENT THE CHANGES AND HOW
WE'RE GOING TO DO THESE THINGS.
>>DR. CRISWELL: AT THE LAST
COUNCIL MEETING ONE CONCEPT THAT
WAS CLEARED WAS EXACT ONE YOU
HEARD ABOUT THEN AND THERE WAS A
SECOND CONCEPT CLEARANCE LAST
TIME TOO I'M FORGETTING.
>>STUART: I AM TOO.
>>DR. CRISWELL: ABOUT DATA
INTEROPERABILITY SOMETHING WE'RE
CONTINUING TO WORK ON ACROSS THE
NIH.
>>STUART: THANK YOU.
THAT'S ALWAYS GOOD TO MAKE SURE
EVERYBODY UNDERSTANDS WHAT WE'RE
DOING.
BESIDES THAT GENERAL IDEA OF
CLEARING CONCEPTS I'D LIKE TO
MAKE A MOTION WE VOTE TO APPROVE
TO MOVE FORWARD WITH THE
CONCEPT.
DO I HAVE A SECOND FOR THAT
MOTION?
THANK YOU VERY MUCH.
IF ANYBODY DISAGREES WITH THIS
PLEASE RAISE YOUR HAND OR SAY
NAY.
SEEING NONE, I SAY THIS MOTION
HAS PASSED AND WE'LL MOVE
FORWARD TO DEVELOP NOFOs AND
OTHER OPPORTUNITIES IN THIS AREA
OF RESEARCH.
>>DR. CRISWELL: WE'RE A LITTLE
BIT OF AHEAD OF SCHEDULE WHICH
IS GREAT BUT WE HAVE A FEW
MINUTES IF OTHER QUESTIONS COME
TO MIND YOU WANT TO RAISE HERE
IN OPEN SESSION.
KEEP IN MIND, I'M AVAILABLE AT
ANY POINT IN TIME AND WE'LL HAVE
OPPORTUNITIES DURING THE LUNCH
SESSION TO EXCHANGE SOME IDEAS
BUT IF ANY QUESTIONS FOLKS WANT
TO RAISE RIGHT NOW IN THIS
CONTEXT, POTENTIAL TOPICS FOR
DISCUSSION AT A FUTURE MEETING,
PLEASE FEEL FREE TO SPEAK UP
NOW.
YOU CAN ALSO RAISE YOUR HAND.
>>I THINK I THREATENED MATLOCK
ABOUT SUGGESTIONS AND IDEAS HE
HAD AND
THE INVESTIGATORS DOING WORK AND
IDEA STATES AND MOVING TOWARDS A
LESS SPECIFICALLY DEFINED
THRESHOLD FOR GRANT FUNDING WILL
ALLOW FLEXIBILITY IN THAT
REGARD.
>>DR. CRISWELL: WE HEARD A
PRESENTATION AT OUR LAST COUNCIL
MEETING ABOUT REVISED REVIEW
CRITERIA.
I THINK THIS IS MEANT IN PART TO
ADDRESS SOME OF THOSE CONCERNS
SPECIFICALLY I REALIZE YOU
WEREN'T WITH US THAT COUNCIL
MEETING THOUGH IT WAS RECORDED
SO YOU CAN GO BACK AND LISTEN TO
THIS PRESENTATION BY NONI BURNS.
ONE OF THE GOALS OF THE REVISED
REVIEW CRITERIA AND SOMETHING
PART OF THE TRAINING STUDY
SECTION MEMBERS ARE UNDERGOING
HAS TO GO WITH MITIGATING
REPUTATIONAL BIAS.
THIS HAS BEEN ILLUSTRATED NICELY
IN SOME ANONYMOUS REVIEW
PROCESSES.
TWO APPLICATIONS COME IN AND
THEY'RE ESSENTIALLY EQUIVALENT
AND ONES FROM HARVARD AND
ANOTHER FROM AN INSTITUTION NOT
WIDELY RECOGNIZED AS BEING A
RESEARCH INTENSIVE INSTITUTION
YOU CAN IMAGINE THAT VEREFLECTE
IN THE REVIEWER SCORE.
IT'S A CHALLENGING ISSUE THAT
HAS TO BE DEALT ON MULTIPLE
FRONTS AND THE REVISED CRITERIA
ARE MEANT TO START CHIPPING AWAY
FROM THOSE ISSUES.
>>MATLOCK: WE HAVE TO RECOGNIZE
THERE'S UNDER RECOGNIZED
POPULATIONS WE DON'T HAVE DATA
FOR AND LGBTQ+ IS STILL HERE.
>>DR. CRISWELL: I KNOW YOU'VE
BEEN TALKING ABOUT DATA WE WANT
AND DON'T HAVE.
MAYBE NOW IS A GOOD TIME --
SORRY TO PUT YOU ON THE SPOT
HERE.
>>ROBERT: ROBERT WALKER THE NEW
CHIEF DIVERSITY OFFICER FOR
NIAMS.
WE'RE ACTIVELY TRYING TO CAPTURE
DATA.
WE'RE TRYING TO FOLLOW THE
SCIENCE AND UNDERSTAND WHAT
WE'RE FUNDING SPECIFICALLY
HBCUs, MSIs, TRIBALS.
WE'RE TRYING TO CAPTURE THE
DATA.
AND THE REVIEW PROCESS IS VERY
IMPORTANT AS WELL.
>>MATLOCK: I THINK MOVING
TOWARDS A DIFFERENT REVIEW
PROCESS, A DIFFERENT APPROVAL
PROCESS MAY OPEN THE ABILITY FOR
US TO PRIVILEGE SOME OF THOSE
THINGS.
>>DR. CRISWELL: THERE'S BEEN AN
INTEREST FOR MANY YEARS TO TRY
TO INCORPORATE THAT IN SOME
FUNDING DECISIONS, FOR EXAMPLE
THE SELECT PAY PROCESS AND WE'VE
BEEN CHALLENGED BY LIMITATIONS
IN THE DATA WE COULD ACQUIRE IN
THE DATA WE COULD COLLECT AND
HAVE ACCESS TO.
IT'S BEEN A CHALLENGING ISSUE TO
ADDRESS.
AS MANY ARE AWARE.
>>ROBERT: IT'S BEEN A STRONG
POINT FOR THE ENTIRETY OF NIH.
WE'RE ALL COLLECTIVELY TRYING TO
IDENTIFY WHAT ARE THE PROPER
QUESTION TO ASK AND IDENTIFY A
CLEAR PATH TO ADDRESSING SOME OF
THESE ISSUES.
>>THIS IS MAYBE MORE OF A CSR
QUESTION BUT WHATEVER CAME OF
THE ANONYMOUS REVIEW TRIALS.
I DON'T KNOW I REMEMBER HEARING
MUCH.
I REMEMBER PARTICIPATING IN IT
BUT DON'T REMEMBER MUCH OF WHAT
THE OUTCOMES ARE.
>>DR. CRISWELL: I'LL SAY AND
HOPEFULLY OTHERS CAN ADD TO THIS
THAT NIAMS UNDERTOOK A GREAT
EXPERIMENT ON THIS FRONT WHICH I
WON'T SPEAK TO BUT PERHAPS BOB
OR GAYLE OR OTHERS COULD BUT THE
FIRST I DON'T KNOW FOR THOSE
FAMILIAR WITH THE FACULTY
INSTITUTIONAL COHORT FRHT
RESOURCE I DON'T REMEMBER WHAT
IT STOOD FOR BUT THERE WAS AN
EFFORT INTENDED TO STRENGTHEN
AND INCREASE THE DIVERSITY OF
THE BIOMEDICAL WORKFORCE,
INSTITUTIONAL GRANTS WERE MADE
AVAILABLE FOR THE FIRST TIME ON
A COMPETITIVE BASIS AND THERE
WAS AN ANONYMOUS PART AND IN
ADDITION TO FIRST PART ANONYMOUS
REVIEW THEY REVIEWED THE
APPLICATIONS INTO TWO POOLS.
ONE, THE LESSER RESOURCED
INSTITUTIONS AND THEN SEPARATELY
FROM THE MORE GENEROUSLY
RESOURCED INSTITUTIONS.
BOB, WAS IT THE RISK PROGRAM?
PLEASE, SOMEONE CHIME IN.
>>BOB: THAT WAS THE FIRST USE
OF ANONYMOUS REVIEW IT WAS PART
OF A TWO-STAGE REVIEW AND
ANONYMOUS AND I WOULD SAY IT'S
FAIRLY SUCCESSFUL.
IN FACT, IT WAS PICKED UP BY
BUILDING 1 TO USE IN THEIR
HIGH-RISK, HIGH-REWARD PROGRAM I
THINK THE DP INVESTIGATOR BUT
I'M NOT POSITIVE ABOUT THAT.
I HAVEN'T SEEN THAT DATA MORE
RECENTLY BUT IF THERE'S A
PROGRAM INVOLVED IN THE ORWH
PROGRAM I'M NOT SURE BUT WE'RE
FINISHING UP THIS YEAR'S SUITE
OF AWARDS FOR THE HRHR PROGRAM
AND ASSUME THEY'RE STILL USING
ANONYMOUS REVIEW BASED ON
EXPERIENCE.
>>THEY ARE.
BEFORE I CAME TO NIAMS I WAS
DOING THAT FOR NIGMS THE
ANONYMOUS REVIEW.
I'LL HAVE TO FOLLOW-UP WITH YOU
ED.
I KNOW CSR HAS HAD GOOD
EXPERIENCE WITH ANONYMOUS
REVIEWS BUT DON'T REMEMBER
OFFHAND WHAT THEY PUBLISHED OR
MADE PUBLIC.
WE CAN FOLLOW-UP AND SEND YOU
THAT INFORMATION.
>>AND RENUKA HAD A QUESTION.
>>RENUKA: I JUST WANTED TO SAY
MY THANKS FOR BEING INVITED HERE
AS AN EARLY CAREER INVESTIGATOR
TO TALK TO COUNCIL.
I FELT LIKE I ALSO WANTED TO
SHARE MY VIEW FROM THE GROUND UP
OF ONE OF THE THINGS I FEEL ARE
AFFECTING ME AND OTHER EARLY
CAREER INVESTIGATORS RELATED TO
THE PANDEMIC.
I'M MAKING THIS COMMENT AS
SOMETHING MORE TO THINK ABOUT IN
FUTURE COUNCIL MEETINGS THAT THE
PANDEMIC HAS KIND OF AFFECTED
THE START OF NEW LABS LIKE MINE.
IT CONTINUES IN THAT IN THE WAY
ELEMENTARY AND HIGH SCHOOL
STUDENTS HAVE LOST A YEAR OR
MORE OF TRAINING, I SEE THAT IN
THE JUNIOR SPECIALISTS I'M
HIRING IN MY LAB, THE
TECHNICIAN.
ONE OF THE THINGS THAT IS
CONSTANTLY COMING UP IN MY
CIRCLES IS THE TRAINING OF
PERSONNEL.
IN ADDITION TO THE POSTDOCS
WE'RE LARGED WITH THAT LAB AND I
LOVE TRAINING AND MENTORING AND
I THINK IT'S A REALLY IMPORTANT
THING AND UNIQUE TO RHEUMATOLOGY
AND THE MISSIONS OF NIAMS THAT
LOOK TO SPEND TIME TO INSPIRING
PEOPLE TO STUDY LUPUS AND OTHER
DISEASES BECAUSE IT'S NOT IN
THEIR COMMON EVERYDAY
EXPERIENCE.
WHAT I WANTED TO PUT OUT THERE
IS I FEEL THERE'S MENTORING
MECHANISMS AND AWARDS AT NIH BUT
MORE TARGETED FOR THOSE WITH A
TRACK RECORD AND THE
REPERCUSSIONS OF THE PANDEMIC
EVEN NOW ARE FELT.
I WANTED TO PUT THAT OUT THERE.
>>DR. CRISWELL: THAT'S WHY YOU
GUYS ARE HERE.
BY THE WAY, WE WOULD LOVE TO
HAVE YOU ENGAGED FOR MORE THAN
ONE COUNCIL MEETING BUT THE RULE
IS ONLY ONE MEETING AS AN AD
HOC.
I HOPE YOU'LL CONTINUE TO LISTEN
IN AND SHARE YOUR INPUT.
AT OUR RETREAT ONE BIG CATEGORY
WE DIDN'T GET TO WAS HOW TO
BETTER SUPPORT INVESTIGATORS AT
ALL STAGES I LOVE THE TOPIC IN
PART BECAUSE I WAS AN EVALUATE
ER AND THERE'S WAYS TO BETTER
SUPPORT INVESTIGATORS INSPIRED
BY APPROACHES IN EUROPE AND
OTHER PLACES AROUND THE WORLD.
THANK YOU FOR RAFRG THE COPPIC.
WE'VE BEEN MEANING TO CIRCLE
BACK TO THAT IMPORTANT ISSUE OF
HOW ARE THE DIFFERENT WAYS WE
CAN SUPPORT INVESTIGATORS.
I KEEP WONDERING ABOUT THE AND I
KNOW JOHN AND OTHERS HAVE BEEN
OBSERVING THE CHALLENGES THE
PANDEMIC HAS POSED FOR THEIR
EARLY CAREER INVESTIGATORS.
THANK YOU FOR SPEAKING UP ABOUT
THAT AND MAYBE YOU'LL BE INVITED
TO A WORKING GROUP TO THINK
ABOUT THESE ISSUES.
OTHER COMMENTS ALONG THOSE
LINES?
MATLOCK OR RENUKA OR ANYBODY
ELSE WANT TO GET US THINKING
ABOUT AN ISSUE TO MULL OVER,
OVER THE NEXT FEW MONTHS.
>>ED: ANOTHER TOPIC IS GRADUATE
STUDENT SUPPORT.
I WANTED TO BRING THIS UP AS IT
RELATES TO TRAINING AND YOUNG
INVESTIGATORS.
CERTAINLY AT GEORGIA TECH AS
OTHER INSTITUTIONS REPRESENTED
HERE ARE TRYING TO STAY
COMPETITIVE WITH SOME OF THE
STIPEND RATES FOR OUR GRADUATE
STUDENTS TO ADDRESS SOME OF THE
STRAINS PLACED UPON THEM AS
WELL.
AS WE ALL KNOW THE R01 BUDGETS
THAT ARE FUNDING A LOT OF THIS
AREN'T NECESSARILY CHANGING THAT
MUCH AND IT'S PUTTING A STRAIN
ON OUR GRADUATE PROGRAMS AND
MAKING US THINK ABOUT HOW WE CAN
ESTABLISH A SUSTAINABLE MODEL
FOR CONTINUING TO ATTRACT AND
SUPPORT THE TALENTED INCLUSIVE
COHORT OF STUDENTS TO OUR
PROGRAMS THIS SAY TRANS-NIH
ISSUE BUT IT'S SOMETHING THAT I
DON'T KNOW IF WE THINK BIT A LOT
AND THOUGHT I'D BRING IT UP AS A
POTENTIAL TOPIC TO ADDRESS IN
SOME MORE SPECIFICS.
>>I JUST WANT TO ECHO THAT AS
AN INSTITUTION WHERE OUR
GRADUATE STUDENTS AND POSTDOC
UNIONIZING MAKE NO MISTAKE THE
END RESULT WILL BE FEWER
GRADUATE STUDENTS.
WE KNOW THAT'S COMING BECAUSE
BUDGETS ARE TIGHT AND IF COSTS
GO UP, IT WILL GO DOWN AND
CALIFORNIA'S EXPERIENCED THAT IN
A BIG WAY AND WE'RE SEEING THAT
ACROSS THE COUNTRY RIGHT NOW.
>>DR. CRISWELL: THESE ARE BIG
IMPORTANT TOPICS.
THERE'S AN ADVISORY COMMITTEE TO
THE NIH DIRECTOR AND THERE'S A
WORKING GROUP THAT MIGHT BE
COMPLETING ITS WORK.
I'M NOT SURE.
IT'S BEEN THINKING OF THE ISSUE
OF POSTDOCS NOT SIMPLY SALARIES
BUT CAREER OPTIONS AND CAREER
TRACKS AND MENTORING AND NUMBERS
AND FUNDING, ETCETERA.
WHEN THAT REPORT IS AVAILABLE
WE'LL TRY TO MAKE AN EFFORT TO
SHARE IT WITH YOU BUT YOU CAN'T
RECALL WHETHER GRADUATE STUDENTS
HAVE BEEN INCLUDED IN THAT
DISCUSSION.
I WONDER WHETHER ANYBODY ELSE IS
AWARE OF WHETHER THEY TACKLED
THE ISSUE OF GRADUATE STUDENTS.
I'LL SHUFR WE'LL HEAR MORE ABOUT
THIS.
THIS IS A CHALLENGE WITHIN THE
NIH AND ACROSS THE NATION.
AND ONCE AGAIN WE CAN'T SOLVE
THE PROBLEMS ON OUR OWN BUT
MAYBE WE CAN HELP ADDRESS THEM
TO SOME EXTENT.
>>I WOULD STRONGLY ENCOURAGE
REACHING OUT TO OUR COLLEAGUES
IN INDUSTRY BECAUSE THEY ARE
GOING TO BE THE PEOPLE THAT
DON'T HAVE ANYBODY WORKING FOR
THEM BEFORE LONG.
THAT IS OUR MISSION.
OUR MISSION IS TO TRAIN GREAT
SCIENTISTS AND THEY GO OFF TO BE
TRAIN GREAT SCIENTISTS LOTS OF
PLACES IN INDUSTRY AND IT WOULD
BE WONDERFUL TO HEAR A VOICE
FROM THEM BECAUSE IT WILL BE
DIFFICULT TO SUSTAIN OUR
BIOMEDICAL ENTERPRISE GOING
FORWARD.
>>DR. CRISWELL: I WISH I HAD A
MORE SATISFYING RESPONSE.
THANK YOU FOR RAISING THE ISSUE.
ANY OTHER COMMENTS OR ISSUES
FOLKS WANT TO RAISE?
WE'RE RIGHT ON TIME.
IT'S 1:14.
JOHN, DO YOU WANT TO SAY
ANYTHING ABOUT INTRAMURAL?
I KNOW YOU'RE DEALING WITH ALL
THESE THINGS IN THE INTRAMURAL
ENVIRONMENT.
>>JOHN: WE'RE IN THE SAME
SITUATION.
IN A FLAT BUDGET THE REALITY IS,
YES, LINDSEY AND I PUSHED
SALARIES TO THE TOP LEVEL
EARLIER THIS YEAR THERE'S A
DISPARITY BETWEEN SALARIES
PROVIDED BY NCI AND THE REST OF
THE NIH AND PUSHED SALARIES UP
BUT THE NET RESULT IS WE'LL HAVE
FEWER PEOPLE.
I'M MEETING TOMORROW WITH
FACULTY MEMBERS AND PLAN FLAT
BUDGETS.
FOR US, WITH A FLAT BUDGET IT
HITS IMMEDIATELY.
>>THERE'S BEEN A BELIEVE
INTRAMURAL IS DIFFERENT THAN
EXTRAMURAL AND FLAT BUDGET IS A
FLAT BUDGET EVERYWHERE.
AS A WORKING GROUP IT WOULD BE
IMPORTANT TO GET REPRESENTATIVES
FROM PFIZER AND NOVARTIS AND YAM
GEN -- AMGEN AND GET THEM AT
THE TABLE BECAUSE THEY'LL BE
PAYING THE PRICE FOR THIS.
>>DR. CRISWELL: OKAY.
ON THAT IMPORTANT AND NOT SO
HAPPY NOTE -- AM I SUPPOSED TO
DO THE GAVEL?
>>LET ME SAY A FEW WORDS AND
THEN YOU CAN DO THE GAVEL.
>>DR. CRISWELL MENTIONED IN HER
REPORT TWO RECENT RFAs THAT WERE
PUBLISHED BY THE NICHD ON BEHALF
OF THE HEAL INITIATIVE.
THEY RELATE TO PAIN IN CHILDREN.
AN AREA HAVE BEEN VERY
INTERESTED IN AND WORKING WITH
OUR COLLEAGUES AROUND NIH.
WE ARE VERY HAPPY HEAL DECIDED
TO BEGIN EFFORTS IN PAIN IN
CHILDREN.
CHILDREN ARE UNDER REPRESENTED
IN THE HEAL INITIATIVE AND THE
PAIN COMPONENT.
THIS IS THE FIRST STEP.
THE FOCUS IS ON ACUTE PAIN
TRIALS AND SO WE WOULD IN
CREATING RESOURCES FOR THE
COMMUNITY NEEDS TO CONDUCT MORE
STUDIES IN PAIN IN CHILDREN IS
AN AREA RELEVANT TO OUR
INSTITUTE.
IF YOU GET AN OPPORTUNITY TO
LOOK AT THE FOAs AND HAVE
COMMENTS ABOUT THEM, PLEASE FEEL
FREE TO REACH BACK TO US BECAUSE
WE CONTINUE TO THINK ABOUT THAT
AREA OF RESEARCH AND HOPE TO
WORK MORE WITH HEAL TO SEE MORE
OPPORTUNITIES COME UP TO SUPPORT
RESEARCH IN TRIALS AND ENCOURAGE
YOUR COLLEAGUES IF THEY'RE IN A
POSITION TO SUBMIT APPLICATIONS
TO DO SO.
THERE'LL BE A WEBINAR COMING UP
IN SEPTEMBER WHERE INVESTIGATORS
COULD ASK QUESTIONS.
PLEASE STAY TUNED AND I'M SURE
BUT PLEASE IF YOU HAVE FEEDBACK
THE SCIENTIFIC COUNCIL'S REPORT
AND THERE'S A SEPARATE ZOOM LINK
FOR THAT MEETING AND ONLY
COUNSEL S WILL RETURN AROUND
3:00 FOR THE CLOSED SESSION OF
COUNCIL.
WE DON'T HAVE A LOT OF TO DO IN
THIS PART OF THE CLOSED SESSION
SO IT SHOULDN'T TAKE TOO LONG
AND WE WANT TO GIVE FOLKS TIME
TO HAVE A LITTLE BIT OF LUNCH
AND THANK YOU ALL VERY MUCH AND
WE'LL SEE YOU ALL IN ABOUT 40
MINUTES.
>>DR. CRISWELL: THAT CONCLUDES
THE OPEN SESSION.
>>THANK YOU, EVERYONE.