GOOD MORNING, EVERYONE.
WELCOME TO NIH COUNCIL OF
COUNCILS. THIS MEETING IS NOW IN
SESSION. I AM NICOLE
KLEINSTREUER, THE ACTING NOOIF
DIRECTOR OF COUNCIL OF COUNCILS.
I'M JOINED BY DR. FRANZISKA
GRIEDER IN THE DIRECTOR OF
OFFICE OF RESEARCH
INFRASTRUCTURE PROGRAMS.
ADDITIONALLY I WOULD LIKE TO
RECOGNIZE MY COLLEAGUES IN THE
ROOM, ROBIN K., DEPUTY DIRECTOR
OF DPCPSI, TAYLOR G., SENIOR
ADVISOR, TINA, PROGRAM ANALYST
AND COUNCIL COORDINATOR AND
GRACE M., HEALTH POLICY ANALYST.
I WOULD LIKE TO THANK THE
COUNCIL TEAM MEMBERS IN SUPPORT
OF ALL THEIR WORK OF THE COUNCIL
ACTIVITIES AND RECOGNIZE THE
LOGISTICS CONTRACTOR FOR COUNCIL
OF COUNCILS, THE CONSULTING
GROUP, OR SCG. BEFORE WE REALLY
GET GOING, LET ME TURN IT OVER
TO FRANZISKA TO REMIND YOU OF A
FEW PROCEDURES BEFORE TAKING
ROLL CALL TO ENSURE THE MEETING
MOVES SMOOTHLY. FRANZISKA THANK
YOU, NICOLE. GOOD MORNING, BOTH
COASTS AND EVERYBODY IN BETWEEN.
WE WILL REMIND YOU OF SOME OF
THE RULES, WHICH WILL HELP TO
ENSURE ALL ARE ABLE TO
CONTRIBUTE. WE ASK YOU REMAIN
MUTED WHEN YOU ARE NOT ACTIVELY
SPEAKING TO THE GROUP. IF YOU
WOULD LIKE TO MAKE A COMMENT OR
ASK A QUESTION, PLEASE USE THE
RAISED HAND FEATURE OR ENTER
YOUR COMMENT OR QUESTION
DIRECTLY INTO THE CHAT BOX. ONE
OF US WILL CALL ON YOU UNMUTE,
IN ORDER WE SEE HANDS RAISED
BEFORE MOVING TO THE CHAT. IF
YOU HAVE TECHNICAL DIFFICULTIES,
PLEASE CONTACT DANIEL OR ALISON
OR ECBC, CONTACT BETINA VIA THE
CHAT BOX. EMAILS ALSO WORK. YOU
SEE EMAILS ON THE SCREEN RIGHT
NOW. WE WILL NOW HAVE
COUNCILMEMBERS INTRODUCE
THEMSELVES, TELLING US YOUR
NAME, YOUR INSTITUTIONAL
AFFILIATION AND INDICATE IF YOU
HAVE SERVED OR SERVING ON AN NIH
OR CENTER -- NIH INSTITUTE OR
CENTER COUNCIL AND WHICH YOU ARE
SERVING ON. I WILL CALL YOUR
NAMES IN ALPHABETICAL ORDER, BY
YOUR LAST NAME. AT THAT TIME
UNMUTE YOURSELF AND SHARE WITH
US THE INFORMATION I JUST
QUOTED. SO LET'S GO. DR.
MONICA G., YOU ARE UP FIRST.
>> SORRY, DR. MONICA GANDGANDHI
PROFESSOR OF MEDICINE IN
DIVISION OF H.I.V., INFECTIOUS
DISEASE AND GLOBAL MEDICINE AT
UCSF. I WAS ON THE O-RACK
ADVISORY COMMITTEE, 2014-2018.
THEN FROM 2019 TO 2030 I WAS ON
NIAD ADVISORY COUNCIL.
>> DR. IRIZARRY.
>> I'M DR. IRIZARRY DEPARTMENT
OF SCIENCE AND PROFESSOR OF
BIOSTATISTICS AT HARVARD SCHOOL
OF HEALTH.
>> THANK YOU.
>> SERVED ON THE NHGR COUNCIL
UNTIL 2019, I THINK. THANK YOU.
>> GREAT, THANK YOU. SORRY, I
JUMPED THE GUN. DR. BARBARA
JOHNSON.
>> SORRY, I CAN'T EVEN READ.
KAREN.
>> MY APOLOGIES. I'M KAREN
JOHNSTON, I'M A PROFESSOR AT THE
UNIVERSITY OF VIRGINIA. I HAVE
PREVIOUSLY BEEN ON NINDS
COUNCIL, THANK YOU.
>> THANK YOU, KAREN. I MIXED THE
NEXT NAME UP WITH YOURS, KAREN.
BARBARA KELLY. I'M GETTING A
SIGNAL BARBARA IS NOT ON YET.
I'M GOING TO GO TO JEAN KING.
>> HI. MY NAME IS JEAN KING,
DEAN OF ARTS AND SCIENCE,
PROFESSOR OF NEUROSCIENCE,
BIOLOGY AND TECHNOLOGY AT
WORCESTER AND SERVED PRIOR TO
THIS COUNCIL.
>> THANK YOU. DR. DICK CRUMAN.
>> I'M DICK CRUMAN,
DISTINGUISHED PROFESSOR OF
PEDIATRICS, COLORADO SCHOOL OF
MEDICINE, PREVIOUSLY ON THE
COUNCIL FROM 2015-2019. IN MY
SIXTH YEAR ON THIS COUNCIL.
>> THANK YOU, DICK. HI THAT YOUR
DOG. I HEARD HIM. DR. KENT
LLOYD.
>> HI, GOOD MORNING EVERYONE.
KENT LLOYD. I'M A PROFESSOR OF
SURGERY, SCHOOL OF MEDICINE.
CALIFORNIA DAVIS. I SERVED ON
THIS COUNCIL NOW ALMOST A DECADE
AGO, SO THEY BROUGHT ME BACK.
THANKS.
>> THANK YOU, KEN. DR. JENNIFER
MANLEY.
>> GOOD MORNING, EVERYONE. I'M
JENNIFER MANLEY. I'M A PROFESSOR
OF NEUROPSYCHOLOGY IN THE
NEUROLOGY DEPARTMENT AT COLUMBIA
UNIVERSITY. I SERVED ON THE NIA,
NATIONAL INSTITUTES ON AGING
COUNCIL. I THINK IT IS MY SECOND
OR THIRD YEAR ON COUNCIL OF
COUNCILS.
>> THANK YOU, JENNIFER.
>> -- NOT SERVED ON ANY OTHER
COUNCILS. I'M HAVING A LITTLE
PROBLEM ON MY VIDEO THIS MORNING
SO I WILL PROBABLY LOG BACK IN
AFTER. THIS ANYTHING ELSE I NEED
TO ADDRESS?
>> I THINK WE ARE GOOD. THANK
YOU.
>> THANK YOU.
>> DR. RUS VAN GIVEELDER.
>> PROFESSOR AND CHAIR IN
WASHINGTON, SEATTLE. I SERVED ON
THE NEI COUNCIL. THIS IS MY
SIXTH YEAR ON COUNCIL AT
COUNCILS AND SERVED A HOCK ON
ADVISORY COUNCIL TO THE
DIRECTOR.
>> BARBARA IS STILL NOT HERE. WE
WILL INTRODUCE HER LATER ON. A
FEW ADDITIONAL ANNOUNCEMENTS.
MEETING MATERIALS WERE SENT TO
YOU MAY 27TH VIA EMAIL FOR
TODAY'S VIRTUAL MEETING. AS
MEMBERS OF THIS COUNCIL OF
COUNCILS, YOU HAVE BEEN TOLD
MANY TIMES YOU ARE SPECIAL
GOVERNMENT EMPLOYEES AND
THEREFORE SUBJECT TO RULES OF
CONDUCT THAT APPLY TO FEDERAL
EMPLOYEES. THESE RULES AND
REGULATIONS ARE EXPLAINED IN A
REPORT ENTITLED STANDARDS OF
ETHICAL CONDUCT FOR EMPLOYEES OF
THE EXECUTIVE BRANCH. YOU
RECEIVED A COPY OF THAT REPORT
WHEN YOU WERE FIRST APPOINTED TO
THE COUNCIL. AT EVERY MEETING,
IN AT DECISION TO REMINDING YOU
ABOUT THE IMPORTANCE OF
FOLLOWING ETHICALS, WE ALSO LIKE
TO REVIEW THE STEPS THAT WE TAKE
AND ASK YOU TO TAKE TO ENSURE
THAT ANY CONFLICT OF INTEREST
BETWEEN YOUR PUBLIC
RESPONSIBILITIES AND YOUR
PRIVATE INTERESTS AND ACTIVITIES
ARE IDENTIFIED AND ADDRESSED.
THREE TIMES A YEAR YOU PROVIDE
US WITH INFORMATION ABOUT YOUR
PERSONAL, PROFESSIONAL AND
FINANCIAL INTERESTS. WE USE THIS
INFORMATION AS THE BASIS FOR
ASSESSING WHETHER YOU HAVE ANY
REAL POTENTIAL OR APPARENT
CONFLICT OF INTEREST THAT COULD
COMPROMISE YOUR ABILITY TO BE
OBJECTIVE IN GIVING ADVICE
DURING THE COUNCIL MEETINGS. IF
SUCH CONFLICTS ARE IDENTIFIED WE
EITHER ISSUE A WAIVER OR RECUSE
YOU FROM A PARTICULAR PORTION OF
THE MEETING. WE ALSO RELY, TO A
GREAT DEGREE, ON YOU TO BE
ATTENTIVE DURING OUR MEETINGS TO
THE POSSIBILITY IF AN ISSUE
ARISES THAT COULD AFFECT OR
APPEAR TO AFFECT YOUR INTERESTS
IN SPECIFIC WAY. IF THAT
HAPPENS, WE ASK YOU RECUSE
YOURSELF FROM THE DISCUSSION.
YOU WOULD DO SO BY USING THE
CHAT FEATURE. THEN WE WOULD MOVE
YOU INTO THE WAITING ROOM. IF
YOU HAVE ANY QUESTIONS ABOUT THE
RULES OF CONDUCT OR CONFLICT OF
INTERESTS, OUR COMMITTEE
MANAGEMENT SPECIALISTS OR I WILL
BE HAPPY TO ADDRESS THOSE
QUESTIONS. FACE USUALLY CONTACTS
YOU ABOUT THE FINANCIAL
INTERESTS, SO YOU ARE FAMILIAR
WITH HER. A FEW MORE ITEMS. TIME
IS ALLOTTED IN EACH HOUR FOR
DISCUSSION BY COUNCIL FOLLOWING
EACH PRESENTATION. UNFORTUNATELY
THERE IS LIMITED TIME FOR ANY
COMMENTS FROM OTHER ATTENDEES.
THE PUBLIC IS WELCOME TO PUB
MITT COMMENTS IN WRITING AFTER
THE MEETING. INSTRUCTIONS IN HOW
TO DO SUBMIT SUCH COMMENTS YOU
CAN FIND IN THE FEDERAL
REGISTER, WHICH WAS PUBLISHED
FOR THIS MEETING ON MARCH 25TH.
APPROVE MINUTES FOR THIS MEETING
WILL BE POSTED ON THE DPCPSI
WEBSITE. AS A REMINDER OF FUTURE
MEETING, DATES ARE ALSO POSTED
ON THE DPCPSI WEBSITE. THERE IS
ONLY ONE MEETING LEFT IN THIS
THAT WE CAN HAVE IT IN PERSON
FOR SEPTEMBER 12TH -- 11 AND 12.
A REMINDER, THE MEETING IS
RECORDED AND WILL BE
TRANSCRIBED. PLEASE UNMUTE
YOURSELF IF YOU SPEAK AND
IDENTIFY YOURSELF. THAT REALLY
HELPS. ALSO PLEASE MUTE YOURSELF
AFTER YOU HAVE FINISHED SO
OTHERS CAN TURN ON THEIR
MICROPHONE. NOTE THE HOST CAN
CONTROL YOUR MICROPHONE IN CASE
YOU TURN IT OFF. A REMIAR REMIN
TURN ON YOUR VIDEO CAMERA WHEN
SPEAKING .ENTER /* IF YOU NEED
ASSISTANCE USE THE CHAT FEATURE
ON TEAMS. THE CLOSED SESSION
WILL BE HELD FROM 12:15 TO 1:15
TO CONDUCT SECOND-LEVEL REVIEW
FOR GRANT APPLICATIONS. IN
ACCORDANCE WITH NIH AND FEDERAL
POLICY ATTENDANCE IS RESTRICTED
TO COUNCILMEMBERS AND RELEVANT
NIH STAFF. THE OPEN SESSION WILL
RESTART AT 1:15. ARE THERE ANY
QUESTIONS AT THIS POINT. NOT
SEEING ANY, I WILL TURN THE
MICROPHONE OVER TO YOU.
>> THANK YOU, FRANCESCA. SO I
WOULD LIKE TO REPEAT THAT WE ARE
IN THE OPEN SESSION OF TODAY'S
MEETING, WHICH MEANS OPEN TO THE
PUBLIC, INCLUDING MEMBERS OF THE
PRESS. WE ARE VIDEO CASTING SO
ALL INTERESTED PARTYIES CAN
LISTEN IN. LET'S KICK THINGS
OFF. AFTER I PROVIDE NIH AND
DPCPSI UPDATES OUR AGENDA WILL
INCLUDE FINAL REPORTS ON TWO
COUNCIL OF COUNCIL'S WORKING
GROUPS .
THE GENERAL REPOSITORY AND THE
OFFICE OF NUTRITION AND DIETARY
SUPPLEMENTS FOLLOWED BY ODS ON
STRENGTHENING, RIGOR AND
REPRODUCIBILITY OF DIETARY
SUPPLEMENTS. SO, AS YOU KNOW,
THE DIRECTORS OF EACH OF THE
DPCPSI PROGRAM OFFICES SERVE AS
NON-VOTING LIAISONS TO THE
COUNCIL. THEY ARE LISTED WITH
THEIR PHOTOS ON THE SLIDE. THEY
ARE ALL ON THE CALL AND
AVAILABLE FOR INPUT OR COMMENTS,
IF NEEDED. OKAY. SO STARTING
WITH THE DPCPSI UPDATES, I WANT
TO ANNOUNCE SOME LEADERSHIP
CHA
CHAN
CHANGES. SO WE CAN MOVE TO THE
NEXT SLIDE. DR. COURTNEY ANY
ACKLAND IS DIRECTOR OF NATIONAL
INSTITUTE OF NURSING RESEARCH,
WHERE SHE HAS SERVED AS DEPUTY
DIRECTOR SINCE 20 # 23 AND
PREVIOUSLY SERVED AT NIH AND
BEFORE THAT SENIOR ADVISOR
WITHIN THE NIH DIRECTOR. SHE HAS
OVER 15 YEARS AT NIH WHERE SHE'S
LEAD ALIGNMENT AND COMPLEX
CHALLENGES IN SUPPORT OF NIH'S
MISSION. DR. ALISON C. IS THE
ACTING DIRECTOR OF EUNICE
SHRIVER CHILD HELP AND HUMAN
DEVELOPMENT, EXECUTIVE DIRECTOR
SINCE 2019 AND PREVIOUSLY SERVED
AS DIRECTOR OF THE NATIONAL
CENTER FOR MEDICAL
REHABILITATION AND IS A NAGS
LEADER IN REHABILITATION
MEDICINE TO COORDINATE AND
RESEARCH RESOURCES IN THIS
FIELD. DR. MONICA WEB-HOOPER IS
NOW SERVING AS ACTING DIRECTOR
OF NATIONAL INSTITUTE ON
MINORITY DISPARITIES, THE DEPUTY
DIRECTOR SINCE 2024. DR.
WEBB-HOOPER CAME FROM CASE
WESTERN, WHERE SHE WAS PROFESSOR
OF ONCOLOGY, FAMILY MEDICINE AND
HEALTH AND SCIENCES. SHE HAS
SEARCHED AT NCI AND CASE
COMPREHENSIVE CANCER CENTER. DR.
ANDREA IS THE ACTING DIRECTOR OF
THE NATIONAL INSTITUTE OF MENTAL
HEALTH, THE DEPUTY DIRECTOR OF
THE BRAIN RESEARCH THROUGH
ADVANCING INNOVATIVE
TECHNOLOGIES OR THE BRAIN
INITIATIVES. SHE PREVIOUSLY HELD
DIRECTOR POSITIONS AT OFFICE FOR
DISPARITIES AND WORKFORCE
DIVERSITY, RURAL MENTAL HEALTH
RESEARCH AND FUNCTIONAL
NEUROGENOMICS IN BASIC BEHAVIOR.
OVER SEEING LARGE PROGRAMS AND
COLLABORATIVE PROGRAMS AT NIH
DURING HER TIME THERE. DR. JE
JEJE
JEFF T. IS AT THE INSTITUTE OF
ALLEY GIS AND CHIEF SINCE 2006
AND PRIOR TO THAT, MOLECULAR
PATHOLOGY AT THE ARMED INSTITUTE
OF PATHOLOGY SINCE 1994. VIRAL
SURVEILLANCE, VIROLOGY AND
BACTERIALOLOGY AND CLINICAL
RESEARCH. LASTLY OUR OWN
DIRECTOR OF OFFICE OF STRATEGIC
COORDINATION OR COMMON FUND AT
DPCPSI, DR. CAROLYN HEADER IS
THE ACTING DIRECTOR OF NATIONAL
HUMAN GENOME INSTITUTE. BEFORE
COMING TO DPCPSI DR. HEADER WAS
AT NHGRI, THE DIRECTOR OF GENOME
SCIENCES AND AS PROGRAM
DIRECTOR, SERVING AS THE NHDR
TEAM LEAD FOR THE ATLAS AND
BRINGS MORE THAN 20 YEARS OF
EXPERIENCE IN GENETICS AND
EPIDEMIOLOGY AS WELL AS MANAGING
LARGE RESEARCH COLLABORATIONS.
WHILE CAROLYN IS AT NHGRI DR.
VIVIAN WANG, DEPUTY DIRECTOR OF
OFFICE RESEARCH ON WOMEN'S
HEALTH WILL SERVE AS ACTING OSC
DIRECTOR. PRIOR WAS AT THE
OFFICE OF DATA SCIENCE STRATEGY
AND SERVED AS INAUGURAL DEPUTY
DIRECTOR OF OFFICE OF DATA
SHARING AT CENTER FOR BIOMEDICAL
INFORMATICS AND TECHNOLOGY AT
THE NCI. SHE WAS THE PROGRAM
DIRECTOR FOR DATA ACCESS AND
SHARING ETHICAL AND LEGAL SOCIAL
IMPLICATIONS RESEARCH PROGRAM AT
NHGRI. WHILE VIVIAN IS AT OSC,
CINDY KAUFMAN, DIRECTOR OF
STRATEGIC ENGAGEMENT AT
PORTFOLIO ANALYSIS WILL SERVE AS
ACTING DIRECTOR OF ORWH.
PREVIOUSLY SHE SERVED AS DEPUTY
DIRECTOR IN OFFICE OF SCIENCE,
POLICY, EDUCATION AND
COMMUNICATIONS AT NHLBI AND
BRANCH CHIEF OF SCIENTIFIC
PLANNING, POLICY AND ANALYSIS
BRANCH IN NIAMS. I THINK THAT IS
ALL THE DOMINOS THAT HAVE BEEN
PUT IN PLACE TO REALLY FILL OUT
OUR LEADERSHIP TEAM IN A VERY
ROBUST WAY. I WOULD LIKE TO
EXTEND MY GRATITUDE TO THE
LEADERSHIP AND APPRECIATION TO
THE DPCPSI COLLEAGUES FOR THEIR
FLEXIBILITY. THE COMMITMENT
THAT'S BEING DEMONSTRATED TO
EXCELLENCE AND RESILIENCE IS
VERY DEEPLY APPRECIATED,
ESPECIALLY DURING TIMES THAT
HAVE TESTED OUR COLLECTIVE
ADAPTABILITY. I THINK IT IS
IMPORTANT TO NOTE WHILE
TRANSITIONS OBVIOUSLY BRING
CHALLENGES THEY ALSO OFFER
OPPORTUNITIES FOR RENEWED
PURPOSE SO I'M REALLY EXCITED TO
MOVE FORWARD UNDER THESE -- THIS
LEADERSHIP. SPEAKING OF WHICH,
NIH IS CENTRALIZING PEER REVIEW
AND EXPERIENCED A WIDE RANGE OF
MECHANISMS BUT AS THEY THE TAKE
ON ALL REVIEW THE LEADER S HAVE
REACHED OUT TO COUNTERPARTS AT
ICs TO LEARN MORE ABOUT PEER
REVIEW PROCESSES UNIQUE TO EACH
ONE. NIH IS AWARE THE IRG AND
SEPs MUST COMPLETE WORK FOR MAY
COUNCIL ROUND BEFORE
TERMINATION. EXACT TERMINATION
DATE IS NOT AVAILABLE. MOST
LIKELY, THE END OF JUNE. MEMBERS
OF STANDING COMMITTEES THAT WILL
BE TERMINATED AND GRANTED
CONTINUOUS -- MEMBERS OF THE
COMMITTEE THAT WILL BE TERMINATE
WILLED BE GRANTED PRIVILEGES
THROUGH AUGUST 10, 2026. THEIR
THEIR SERVICE IS VERY MUCH
APPRECIATED AND CSR RECOGNIZES
THE EXPERTISE AND ARE LIKELY TO
REACH OUT AND INVITE THEM TO
SERVE ON CSR PANELS MOVING
FORWARD. APPLICATIONS THAT WOULD
HAVE BEEN REVIEWED WILL BE
REVIEWED AND WILL BE REVIEWED IN
A TIMELY FASHION BY CSR. ON
APRIL 29TH, NIH ANNOUNCED ITS
COMMIT TO DEVELOPING, VALIDATING
AND SCALING NEW APPROACH
METHODOLOGIES OR NAMS ACROSS THE
BIOMEDICAL RESEARCH PORTFOLIO,
TECHNIQUES DESIGNED TO MODEL
HUMAN BIOLOGY AND COMPLEMENT
TR
TRADITIONAL ANIMAL STUDIES. IN
SOME CASE, SERVING AS
ALTERNATIVES. WE KNOW THE ANIMAL
MODELS DON'T BE IMPORTANT TO
ADVANCING OUR SCIENTIFIC
KNOWLEDGE BUT WE ALSO RECOGNIZE
NAMS OFFER STRENGTHS THAT WHEN
UTILIZED CORRECTLY OR IN
COMBINATION CAN EXPAND THE TOOL
BOX FOR RESEARCHERS TO ANSWER
PREVIOUSLY DIFFICULT OR
UNANSWERABLE BIOMEDICAL RESEARCH
QUESTIONS. THIS IS NOT
BRAND-NEW. THERE ARE LOTS OF
NAMS ACTIVITIES GOING ON ACROSS
THE ICOs AND AGENCY INVESTMENT
HAS BEEN INCREASING OVER TIME.
SO THE INTENTION HERE IS TO
BUILD ON THOSE EXISTING EFFORTS,
INCLUDING THE VALIDATION WORK OF
THE INTERAGENCY COMMITTEE,
ICVAM, MY FORMER HOME. PROGRAMS
LIKE THE NCAT PROGRAM, THE 3D
TISSUE BIOPRINTING PROGRAM, WORK
OF THE COMMON FUNDS
COMPLEMENTARY RI PROGRAM SO
COMPLEMENTING ANIMAL RESEARCH
AND EXPERIMENTATION. TO BRING
ALL THOSE TOGETHER IN A
COORDINATED FASHION AND TO WORK
ACROSS THOSE EFFORTS AND DEVELOP
AND INTEGRATE NAMS MORE
COMPREHENSIVELY INTO THE
BIOMEDICAL RESEARCH PORTFOLIO.
JUST LAST MONTH THE
COMPLEMENTARY RI PROGRAM
PARTNER ED WITH THE FOUNDATION
-- FOUNDATION FOR NIH, FNIH TO
ENHANCE ADOPTION AND USE THROUGH
ESTABLISHMENT OF EVALUATION AND
QUALIFICATION SO THE VQN IS
GOING TO BE WORKING WITH THAT
PUBLIC-PRIVATE PARTNERSHIP AND
REGULATORY COLLEAGUES TO ENSURE
THAT ANY NAMS DEVELOPED THAT
SHOW PROMISE WILL BE RIGOROUSLY
AND ROBUSTLY EVALUATED AND
VALIDATED FOR POTENTIAL USE IN
REGULATORY DECISION MAKING. SO
WE ARE ALL VERY EXCITED ABOUT
INF
NIH'S COMMITMENT TO EXPAND THESE
TECHNOLOGIES. LED BY ODSS NIH
RELEASED PLAN FOR DATA SCIENCE
FOR 2025 TO 2030 ON
JANUARY 17TH. THIS PLAN PREPARES
NIH TO NAVIGATE EVOLVING
TECHNOLOGY LANDSCAPE, ADDRESS
RAPID RISE IN QUANTITY AND
DIVERSITY AND BRIDGE NEW DATA TO
EXISTING KNOWLEDGE. SO NIH'S
GOALS TO ACHIEVE THIS VISION ARE
TO SUPPORT DATA MANAGEMENT AND
FED RATED RESOURCES, ENHANCE
HUMAN-DERIVED DATA FOR RESEARCH,
CREATE NEW OPPORTUNITIES IN
SOFTWARE, COMPUTATION AND AI AND
STRENGTHEN THE DATA SCIENCE
COMMUNITY. THEN IN FEBRUARY AND
APRIL THE TRIBAL HEALTH RESEARCH
OFFICE, OR THRO LED NIH'S
PARTICIPATION IN CONSULTATION
MEETINGS HELD AT HSSS
HEADQUARTERS. SECRETARY
ROBERT F. KENNEDY , JR. AND
OTHERS MET WITH STAFF AND DR. B.
WAS INTRODUCED TO TRIBAL LEADERS
AND PART OF A PANEL ON CHRONIC
DISEASE DURING THE ATVC,
FOLLOWED BY AN UPDATE AND Q&A
WITH STAT. TRIBAL LEADERS
STRONGLY ADVOCATED DURING THESE
MEETINGS FOR ONGOING HEALTH
INITIATIVES AND EXPANDED
WORKFORCE DEVELOPMENT PROGRAMS
IN INDIAN COUNTRY. NEXT NIH
OFFICE OF RESEARCH ON WOMEN'S
HEALTH RECOGNIZES THE NATIONAL
WOMEN'S HEALTH WEEK EACH YEAR .
WITH THE VIVIAN PIN SYMPOSIUM,
HONORING THE FIRST FULL-TIME
DIRECTOR, VIVIAN W. PIN. THIS
YEAR'S SEMINARY, ADVANCING FOR
THE HEALTH OF WOMEN FOCUSED ON
SKILLS, RESOURCES TRAINING CAN
BUILD CAPACITY FOR
INTERDISCIPLINARY DATA ANALYSES.
THE SIMIYMPOSIUM FOCUSED AROUND
REAL WORLD SCIENCE AND DATA
PRIVACY . IF YOU WERE UNABLE TO
ATTEND, YOU ARE IN LUCK. THE
SYMPOSIUM WAS RECORDED AND CAN
BE VIEWED ON NIH VIDEOCAST OR
SCANNING THE QR CODE ON THE
SLIDE. FOR OUR LAST UPDATE,
SCIENTISTS WORKING ON THE GENE
DISRUPTION PROJECT AND
TRANSGENIC PROJECT HAVE BEEN
HONOR ED WITH RECEIVING THE 2025
COMMUNITY AWARD FOR OUTSTANDING
CONTRIBUTIONS TO TECHNOLOGY AND
RESOURCES THAT HAVE BENEFITTED
ALL OF THESE RESEARCHERS. THESE
PROJECT, PRIMARILY FUNDED BY
GROUP, HAVE GENERATED OVER
34,000 STOCKS TO THE CENTER.
THIS CENTER PARTLY SUPPORTED BY
OREP, NIGMS AND NINDS HAS
DISTRIBUTED OVER A MILLION
SAMPLES FROM THESE TWO TO THE
RESEARCH COMMUNITY IN THE PAST
20 YEARS. THESE RESOURCES HAVE
HAVE ENABLE ABLED A BROAD RANGE
OF ALMOST EVERY GENE ON THE FLY
AND PROVIDED INSIGHT TO
MECHANISMS, DIAGNOSIS AND
TREATMENT OF A WIDE RANGE OF
HUMAN DISEASE. OKAY. THAT
CONCLUDES THE NIH DPCPSI
UPDATES.
WE DO HAVE TIME FOR
QUESTIONS SO I CAN OPEN UP THE
FLOOR TO QUESTIONS FROM
COUNCILMEMBERS.
>> I HAVE A QUESTION.
>> DR. MANLEY, PLEASE GO AHEAD.
>> THANK YOU. THANK YOU SO MUCH
FOR THAT UPDATE. MY QUESTION IS
ABOUT THE HIGH-RISK, HIGH-REWARD
PROGRAMS. COUNCIL OF COUNCILS IS
IN CHARGE -- PART OF OUR CHARGE
IS TO ADVISE THE NIH DIRECTOR ON
NIH-WIDE INITIATIVES, LIKE THE
COMMON FUND, HIGH-RISK,
HIGH-REWARD PROGRAMS, WE
ENTHUSIASTICALLY APPROVED THESE
CONCEPTS IN APRIL. WE ARE ALSO
CHARGED WITH PERFORMING THE
SECOND LEVEL OF REVIEW FOR
HIGH-RISK, HIGH-REWARD PROGRAMS
AND ASSESSING THE FIRST LEVEL OF
REVIEW FOR FAIRNESS AND
UNIFORMITY IN THE APPLICATION OF
REVIEW CRITERIA. AT OUR APRIL
COUNCIL MEETING, AS I MENTIONED,
WE ENTHUSIASTICALLY APPROVED
CONSENTS FOR THESE HIGHLY
SELECTED PROGRAMS THAT FOSTER
SCIENTIFIC LEAPS, ENCOURAGE
CREATIVITY AND INNOVATION AND
EMPHASIZED THE DEVELOPMENT OF
THE NEXT GENERATION OF
SCIENTISTS. AT THESE,
APPLICATIONS ARE AVAILABLE TO
PEOPLE ACROSS SCIENTIFIC AREAS
AND INVESTIGATORS ACROSS NIH
INSTITUTES. SO ARE UNIQUE IN
THAT WAY. THE N. O. T. OR NOTICE
OF INTENT TO POST FUNDING
ANNOUNCEMENT FOR THE DP1
PROGRAM, WHICH IS PIONEER'S
AWARD DP2, INNOVATORS, THESE ARE
BEEN POSTED ONLINE BUT THE DP5
OR EARLY INDEPENDENCE IS NOT
THERE. NORMALLY THE
ANNOUNCEMENTS ARE ISSUED EVERY
YEAR IN MARCH. IF THESE ARE
POST ED IN JUNE, AS ESTIMATED,
THE TURNAROUND TIME APPLICANTS
WILL HAVE WILL BE SEVERELY
CONSTRICTED. DUE DATES ARE
NORMALLY SEPTEMBER BUT THE NEW
DP2 DUE DATE IS ESTIMATED TO BE
AUGUST 19, 2025, LEAVING ONLY
TWO MONTHS TO RESPOND. IN THE
NOTICE OF INTENT FOR THE DP2
AWARD, THE NUMBER OF AWARDS HAS
BEEN REDUCED FROM 35 TO 30. THE
PROGRAM -- OR THE FUNDING FOR
THE PROGRAM IS REDUCED FROM 44
MILLION TO 37.7 MILLION. AT
LEAST SIX HIGH-RISK, HIGH-REWARD
PROGRAMS HAVE BEEN CANCELLED
SINCE JANUARY 2025. THESE ARE
ALREADY FUNDED PROGRAMS, ALREADY
REVIEWED PROGRAMS. THERE'S FOUR
DP2s AND TWO DP5s. SO MY
QUESTIONS ARE, I WILL PUT THESE
IN THE CHAT, WHEN DO YOU EXPECT
DP5 MECHANISM TO BE POSTED IF I
WON'T BE, WHY WON'T IT BE. WHAT
IS THE RATIONALE FOR REDUCTION
IN SUPPORT FOR THE DP TOOL OR
NEW INVESTIGATOR AWARDS --
SORRY, NEW INNOVATOR AWARDS,
GIVEN THE WILD SUCCESS OF THESE
GRANTS IN THE PAST. AND A WINDOW
BETWEEN POSTING OF THE RFAs AND
DUE DATES, ESPECIALLY FOR THE
DP2 PROGRAM AND YOU CLARIFY
COUNCIL COUNCIL'S ROLE IN
ASSESSING FAIRNESS UNITED
NATIONS FORMTY OF VIEW OF
HIGH-RISK AND IE-REWARD NOW THAT
STOP WORK ORDER S HAVE BEEN
ISSUED TO AT LEAST SIX GRANTS IN
THIS PROGRAM THAT WERE
PREVIOUSLY REVIEWED AND APPROVED
BY COUNCIL, THANK YOU.
>> THANK YOU, DR. MANLEY. I DO
APPRECIATE YOU PUTTING THOSE
QUESTIONS IN THE CHAT WHENEVER
YOU HAVE A MOM MOMENT TO ENSURE
DON'T MISS THEM. I CANNOT SPEAK
-- I CAN NOT PROVIDE A
COMPREHENSIVE ANSWER TO EVERY
QUESTION YOU HAVE ASKED. I WILL
TURN -- I DO NOT ACTUALLY SEE
ANY OF MY OSC COLLEAGUES ONLINE
AT THE MOMENT, BUT IF ANY OF
THEM ARE THERE AND WOULD LIKE TO
WEIGH IN ON THAT, I WILL
OBVIOUSLY OPEN UP THE FLOOR TO
THEM. BUT I CAN PROVIDE AS MUCH
INFORMATION AS I HAVE AVAILABLE
AT THIS TIME. LOOKING
SPECIFICALLY FIRST AT THE EARLY
INDEPENDENCE AWARD WE DID
RECEIVE INITIAL FEEDBACK THROUGH
THE INTERNAL REVIEW PROCESS AND
LOOKING AT FURTHER OPTIONS AND
TIMING FOR REISSUING THE NOFO AS
SOON AS POSSIBLE SO WE ARE AWARE
AND ADDRESSING IT. THE RATIONALE
FOR REDICT AND SUPPORT FOR THE,
AGAIN, I WOULD PASS THAT
QUESTION TO MY OSC COLLEAGUES,
WHO I DON'T SEE ONLINE BUT WE
CAN TAKE THAT QUESTION BACK TO
THEM AND COME BACK TO YOU. BUT
MY ASSUMPTION IS THIS IS DUE TO
BUDGET CONSTRAINTS. HOW WILL WE
REDUCE THE NEGATIVE IMPACT OF
THE CONSTRICTED WINDOW BETWEEN
POSTING AND DUE DATES, WE WILL
REVIEW ALL OF THE APPLICATIONS
RECEIVED IN A TIMELY PROCESS AND
ENSURE AWARDS ARE MADE AS
EXPEDIENTLY AS POSSIBLE. CAN I
CLARIFY COUNSEL'S ROLE IN
PROGRAM NOW THAT STOP WORK
ORDERS HAVE BEEN ISSUED TO AT
LEAST SIX GRANTS REVIEWED AND
APPROVED BY COC. THE STOP WORK
ORDERS, I PRESUME, WERE ISSUED
DURING THE REVIEW PROCESS, THE
DOGE REVIEW, TO ENSURE CONSIST
TENSE WITH EXECUTIVE ORDERS WE
HAVE RECEIVED. THAT DOES NOT
CHANGE COUNCIL'S ROLE IN
ASSESSING THE HRHR PROGRAM
MOVING FORWARD. COUNCIL STILL
RETAINS THAT ROLE.
>> LET ME JUST REQUEST, MAYBE BY
THE END OF THE DAY, YOU KNOW, IN
ANOTHER PORTION OF OUR SESSION
WE CAN GET THE ANSWER FROM --
THAT YOU WERE SEEKING ABOUT THE
REDUCTION IN SUPPORT FOR THE
DP2s. THAT WOULD BE WONDERFUL. I
WILL QUICKLY ASK THE
INFORMATIONAL WEBINARS FOR
APPLICANTS NORMALLY TAKE PLACE
IN LATE JUNE. THAT IS A KEY PART
OF ORIENTING THE SCIENTIFIC
COMMUNITY ABOUT HOW TO APPLY.
THERE IS A RESTRICTED TIME WHEN
THE RFA COMES OUT AND WHEN
APPLICATIONS ARE DUE AND ROLL
OUT FOR APPLICANTS.
>> THANK YOU. I WILL GO BACK TO
MY COLLEAGUES. MY PRESUMPTION IS
THEY ARE CONTINUING TO HOLD THEM
IN LATE JUNE, AS PLANNED. WE
WILL CONFIRM THAT WITH THEM AND
GET BACK TO YOU, THANK YOU. DR.
GANDHI.
>> THANK YOU FOR THE OPPORTUNITY
BE ON THIS COUNCIL. ONE QUESTION
I HAD WAS THE SIGNIFICANT
RESTRIKE AGRICULTURING OF THE
INSTITUTES PROPOSED BY THE
PASS-BACK BUDGET THAT WAS
REVEALED TO -- I THINK
WASHINGTON POST REVEALED IT
APRIL 16TH. THE CONSOLIDATED
INSTITUTES WERE REALLY
DIFFERENT. FOR EXAMPLE, NIMH,
NIDA, NIAA WOULD GO UNDER
SOMETHING LIKE NATIONAL
INSTITUTES OF BEHAVIORAL HEALTH
SO SEEMED LIKE A MASSIVE
RESTRUCTURING. WHEN WE LOOKED AT
THE CHARTER OF COUNCIL OF
COUNCILS, IT SEEMED LIKE
ANYTHING THAT WOULD INFLUENCE
REORGANIZATION AND STRATEGIC
COORDINATION AND PLANNING WOULD
BE WITHIN THE CHARTER OF THE
COUNCIL OF COUNCIL'S ABILITY TO
ADVISE SO WANTED TO ASK ABOUT IS
OUR CHARTER STILL THE SAME FOR
COUNCIL OF COUNCILS TO ADVISE
SOMETHING AND ADVICE SOMETHING
LIKE RESTRIKE AGRICULTURE. AND
THAT WOULD RELATE TWO OTHER
MAJOR RELATE TO. ONE IS SHORT IS
SUPPOSED TO BE 27 MEMBERS, NOW
CURRENTLY 10, THOUGH OTHER S
HAVE BEEN APPROVED. ALSO, FOR
EXAMPLE, SOMETHING LIKE THE
FOREIGN SUB AWARD, NOTOD, 25104
MAY 1ST WHICH SIGNIFICANTLY
CHANGES FUNDING STRUCTURE OF NIH
AND HALTED AT THIS MOMENT GLOBAL
RESEARCH AT THE NIH. SO IT IS
REALLY MORE OF A PHILOSOPHICAL
QUESTION ABOUT IS OUR CHARTER
STILL THERE. HAS IT CHANGED AND
COULD WE ADVISE ON THESE TOPIC,
RESTRUCTURING FOREIGN SUB AWARDS
AND MEMBERSHIP -- IF THIS
MEMBERSHIP NUMBER REMAINS THE
SAME.
>> THANK YOU DR. GANDHI. THE
CHARTER OF COUNCIL OF COUNCILS
HAS NOT CHANGED. WE CAN DISCUSS
WHETHER OR NOT RESTRICT PROPOSED
RESTRUCTURING IS SOMETHING THAT
WOULD BE AN AGENDA ITEM FOR
DISCUSSION AND ADVICE IN FUTURE
COUNCIL MEETINGS. WE ARE AWARD
TO CONSOLIDATE THE 27 INSTITUTES
AND CENTERS. THIS PROPOSAL
OUTLINES RESTRUCTURING TO
RETAINING THE NATIONAL CANCER
INSTITUTE, NATIONAL INSTITUTE OF
ALLERGY AND INFECTIOUS DISEASES
AND NATIONAL INSTITUTE OF AGING
AND CONSOLIDATE THE REMAINING
INTO FIVE NEW ONES, NATIONAL
INSTITUTE ON BODY RESEARCH,
BRAIN, GENERAL SCIENCES,
DISABILITY-RELATE AND BEHAVIORAL
HEALTH. THAT IS THE PROPOSAL
THAT IS PART OF THE OMB BUDGET
IN THE PRESIDENT'S BUDGET.
REGARDING THE NIH POLICY ON
FOREIGN SUB AWARDS I THINK
PROBABLY MANY OF YOU HAVE READ
THE POLICY AND ARE AWARE THAT WE
ARE WORKING VERY HARD TO
ESTABLISH A NEW AWARD STRUCTURE
BY THE END OF SEPTEMBER SO BY
SEPTEMBER 30TH, 2025, THAT
PROHIBITS FOREIGN SUB AWARDS
FROM BEING NESTED UNDER THE
PARENT GRANT BUT IMPLEMENTS A
NEW AWARD STRUCTURE THAT
INCLUDES A PRIME WITH
INDEPENDENT AWARDS TO MORE TRACK
INDIVIDUALLY WHILE SCIENTIFIC
PROGRESS COLLECTED BY THE
PRIMARY INSTITUTION. UNTIL THAT
IS IN PLACE NIH WILL NOT ISSUE
AWARDS THAT INCLUDE A FOREIGN
SUB AWARD. THIS IS A TEMPORARY
PAUSE WHILE NIH FINALIZES
IMPLEMENTATION OF STRUCTURE
WHICH IS EXPECTED NO LATER THAN
SEPTEMBER. THE INTENTION HERE IS
TO HAVE A CLEARER STRUCTURE AND
SAFEGUARDS TO ENHANCE
TRANSPARENCY, TRACKABILITY AND
PROTECT NATIONAL SECURITY IN
AREAS OF MONETARY AND
NON-MONETARY FOREIGN
COLLABORA
COLLABORATION. I THINK I
ADDRESSED ALL THE POINTS.
>>> I THINK THE LAST WAS
27-MEMBER COMMITTEE AND WE KNOW
OUR COLLEAGUES HAD BEEN
APPROVED. NOW IT IS CURRENTLY
TEN.
>> CORRECT. WE -- SO THE
APPROVAL PROCESS IS STILL
UNDERWAY. WE HAVE PENDING
MEMBERS THAT HAVE BEEN NOMINATED
OVER THE PAST TWO YEARS. WE ARE
CURRENTLY GOING THROUGH,
NOMINATING PEOPLE FOR 2025
VACANCIES. HOWEVER, WITH THE
HIRING FREEZE IT IS ACTUALLY NOT
POSSIBLE FOR US TO APPOINT NEW
MEMBERS AT THIS TIME. BUT WE ARE
WORKING ON CLEARING THIS BACKLOG
AS SOON AS --
>> OKAY, THANK YOU. THANK YOU.
>> THERE LLOYD I THINK WAS NEXT.
>> HI, GOOD MORNING DR.
KLEINSTREUER. JUST FOLLOWING UP
ON MONICA'S COMMENTS, YOU KNOW,
JUST TO BE FRANK, I THINK A LOT
OF US ARE SKEPTICAL THAT THIS
PLAN FOR RESTRUCTURING AT NIH IS
GOING TO LEAD TO THE
ADMINISTRATION'S EFFORT TO MAKE
AMERICA HEALTHY AGAIN.
ESPECIALLY IN LIGHT OF THE
PROPOSED SIGNIFICANT PROPOSED
REDUCTION AND BUDGET TO THE NIH
SO REMAINS KIND OF QUESTIONABLE.
MY QUESTION IS REGARDING YOUR --
THANKS FOR THIS PRESENTATION YOU
MADE ABOUT PRIORITIZING
HUMAN-BASED RESEARCH
TECHNOLOGIES. I DON'T THINK YOU
MENTIONED THIS ANNOUNCEMENT THAT
CAME OUT AT THE SAME TIME AS
APRIL 29TH, EIGHT DAYS AFTER OUR
LAST COUNCIL MEETING. THIS
CREATION OF OFFICE RESEARCH AND
VALIDATION FOR RIVA P SO
WONDER ING IF YOU COULD MAYBE
COMMENT ABOUT THAT. WHAT EXACTLY
THAT WILL BE DOING. I NOTICED,
AND YOU ARE VERY CAREFUL AND I
APPRECIATE THAT OF MENTIONING
HOW NOVEL ALTERNATIVE METHODS,
WHICH I THINK ARE FANTASTIC.
THEY ARE TO COMPLEMENT
BIOMEDICAL RESEARCH AND
COMPLEMENT ANIMAL NOD DELL USE
AND NOT TO REPLACE THEM SO I'M
REALLY HAPPY TO HEAR YOU SAID
THAT. THERE STILL REMAINS A LOT
OF CONCERN OUT HERE IN THE
SCIENTIFIC COMMUNITY THAT --
WITH OTHERS THAT ARE SPEAKING
THAT THERE REALLY IS AN EFFORT
TO ELIMINATE SUPPORT FOR ANIMAL
RESEARCH. YOU KNOW, WE HAVE SEEN
JUST OVER THE LAST WEEK THIS
FANTASTIC NUMBER OF PAPERS
COMING OUT IN REPORTS IN FACT,
OF HOW ANIMAL-BASED RESEARCH HAS
BEEN ABSOLUTELY INCREDIBLE AND
INCREDIBLY IMPORTANT FOR HUMAN
HEALTH RESEARCH. I WILL JUST
GIVE THE EXAMPLE THAT CPS1
TREATMENT BY THIS PERSONIZED
CRISPR BASED PRIME EDITING AT
CHOP, YOU KNOW, IT IS CITED IN
THE ANNOUNCEMENT AND PAPER THEIR
NECESSITY FOR MOUSE MODELS TO
VALIDATE THE TECHNIQUE AND
NON-HUMAN PRIMATES TO TEST IT.
JUST WONDER ING IF YOU COULD
COMMENT ABOUT OR RIVA WHAT YOUR
PLANS OR I IMAGINE OFFICE AS
OFFICE OR DIRECTOR OR DPCPSI AND
YOUR THOUGHTS ABOUT ALL THAT,
THANKS.
>> THANK YOU, DR. LLOYD. YES. SO
THE -- I LIKE TO PRONOUNCE IT
ORIVA, BUT TO EACH HIS OWN. THIS
INTENT IS PART OF A PROPOSAL
THAT WILL NEED TO BE APPROVED BY
HHS AND, YOU KNOW, CONGRESS WILL
NEED TO BE NOTIFIED. SO THAT
ISN'T FINALIZED YET BUT THE
INTENT OF ORIVA IS ACTUALLY TO
FUNCTION MUCH IN THE SAME WAY
THAT MANY OF THE OTHER DPCPSI
OFFICES FUNCTION. IF YOU TAKE
OWRH OR OTHERS THESE ARE
CROSS-CUTTING THEMES. MANY OF
ALL THE NIH INSTITUTES AND
CENTERS HAVE VERY ROBUST
PROGRAMS IN. NAMS HAS REALLY
OVER THE LAST SEVERAL DECADES
RISEN TO THE LEVEL OF NEEDING A
COORDINATING OFFICE TO ENSURE
THE NIH-WIDE EFFORTS TO DEVELOP,
VALIDATE AND SCALE THE USE OF
NEW APPROACH METHODOLOGIES ARE
WORKING EFFECTIVELY TOGETHER. SO
THAT WE CAN REALLY COORDINATE
ACROSS THE AGENCIES BIOMEDICAL
RESEARCH PORTFOLIO TO SERVE AS
HUB FOR ENTER AGENCY
COORDINATION, TO ENSURE THESE
NAMS DEVELOPED TO BE AS RELEVANT
AND TRANSLATIONAL AS POSSIBLE TO
HUMAN HEALTH ARE BEING DEVELOPED
ROBUSTLY AND EVALUATED AND
VALIDATED TO ENSURE THEIR
SUITABILITY AND CONVERSATION AND
THEIR USE FOR ARING TOIR
DECISION MAKING AND BIOMEDICAL
RESEARCH INSIGHTS AND
DISCOVERIES. SO THAT IS OUR
VISION FOR ORIVA'S FUNCTION. WE
ALSO ENVISIONED EXPANDING TO,
AGAIN, MUCH LIKE ANY OF THE
OTHER DPCPSI OFFICES, HAVING
CO -FUNDING OPPORTUNITIES IN
PARTNERSHIP WITH OTHER ICs
WORKING IN THE SPACE, EXPANDING
TRAINING IN NON-ANIMAL
APPROACHES, DEVELOPING BETTER
EVALUATION CRITERIA TO ASSESS
THOSE METHODS BASED ON THEIR
SUITABILITY, CONTEXT OF USE,
TRANSLATIONAL RELEVANCE, ET
CETERA. WORKING WITH GREAT
REVIEW STAFF TO BETTER INTEGRATE
EXPERTS ON NAMS INTO VARIOUS
STUDY SECTIONS SO THOSE ARE
IDEA S IF INCLUDED FOR INCLUSION
IN DPCPSI.
>> I THINK THAT IS ALL VERY
INTRIGUING AND APPRECIATE THAT
FURTHER EXPLANATION. I THINK IT
IS IMPORTANT -- YOU KEEP USING
THE WORD VALIDATION. I THINK
VALIDATION INCLUDES VALIDATING
INVIVO COMPLEX SYSTEMS LIKE A
MOUSE OR NON-HUMAN PRIMATE, YOU
MENTIONED THE AWARD. SO IT IS
REALLY IMPORTANT WE PROTECT THE
STOCK CENTERS THAT ARE OUT
THERE, PROVIDING THOSE ANIMAL
MODELS FOR PEOPLE TO USE AND,
IMPORTANTLY, FOG BEING ABLE TO
VALIDATE THESE NAMS AND THEY
COME ONLINE.
>> THANK YOU FOR YOUR FEEDBACK.
NOTE THOSE FOR THE ORO RESEARCH
CENTERS ARE CONTINUING AND , IN
FACT, HAVE WE HAVE BEEN WORKING
RECENTLY TO EXPAND THEM AND
INCLUDE MENTION OF EMPHASIS ON
NAMS AS COMPLEMENTARY RI
ACTIVITIES TO THE ANIMAL MODELS
SUPPORTED BY THOSE RESOURCE
CENTERS. DR. VAN GELTER THEN WE
HAVE TO MOVE ON SO WE HAVE TO
KEEP TO OUR AGENDA. WE WILL HAVE
TIME POTENTIALLY LATER IN THE
MEETING TO REVISIT SOME OF YOUR
QUESTIONS, ASSUMING WE CAN STAY
ON TRACK AS FAR AS THE AGENDA
GOES. PLEASE GO AHEAD, RUSS.
>> -- CURRENTLY AND COMING BACK
TO THE NIH ISSUE, WE DISCUSSED
THIS AT THE LAST COUNCIL OF
COUNCIL MEETING IN 2024 UNDER
YOUR PREDECESSOR AND I BELIEVE
BROUGHT UP TO ADVISORY MEETING
TO THE DIRECTOR, THERE IS A CON
ARE CONGRESSLY MANDATED PROCESS
FOR COORDINATION OF NIH, UNDER
THE REFORM ACTIVE 2006, WHICH
STARTS WITH THE SECRETARY OF
HEALTH AND HUMAN SERVICES,
GIVING 180 DAYS NOTICE FOR
POSSIBLE REORGANIZATION. THEN A
PROCESS IN WHICH THE SCIENTIFIC
MANAGEMENT REVIEW BOARD COMMENTS
ON THE POTENTIAL REORGANIZATION.
FOLLOWED BY THEN PUBLIC HEARINGS
AND ULTIMATELY CONGRESSIONAL
LEVEL APPROVAL, OR AT LEAST
CONGRESSIONAL NOTIFICATION. WE
WERE TOLD IN THE FALL THE SMRB,
THE SCIENTIFIC MANAGEMENT REVIEW
BOARD, HAD BEEN RECHARTERED.
DORMANT FOR A NUMBER OF YEARS.
IT IS ONLY REQUIRED TO MEET
EVERY SEVEN YEARS. IT WAS
BEGINNING A PROCESS TOWARDS
LOOKING AT REORGANIZATION. IT
APPEARS THE CURRENT
RECOMMENDATION, AT LEAST FROM
THE PRESIDENT'S BUDGET, BYPASS
THIS AND ASSUME REORGANIZATION
INTO A SMALLER NUMBER OF
INSTITUTES AND CENTERS, WHICH
WILL OBVIOUSLY HAVE TREMENDOUS
REPERCUSSIONS UNDER THE
PORTFOLIO THAT HAPPENS UNDER NIH
AND AFFECT MANY PROPOSALALS FROM
THE COMMENT FUND. CAN YOU GIVE
AN UPDATE ON THAT PROCESS. IN
PARTICULAR, WHAT THE SMRB STATUS
IS, WHETHER THEY HAVE MET YET OR
WHETHER THEY HAVE A MEETING
PLANNED, AND IF THAT WILL BE
PUBLIC.
>> THANK YOU FOR THE COMMENTS,
DR. VAN GELDER. YOUR COMMENTS
SUMMARIZED EFFECTIVELY THE
STATUS OF THIS PARTICULAR ISSUE
SO AS YOU NOTED SMRB WAS
RECONSTITUTED, RECHARTERED. THEY
HAVE NOT MET YET. I AM NOT AWARE
OF A PLANNED MEETING SO THAT --
I GUESS THAT IS NOT THE MOST
SATISFACTORY ANSWER BUT ALL THE
INFORMATION I HAVE AVAILABLE AT
THIS TIME, THANK YOU.
>> MAY I INTERRUPT. IF WE ARE
MOVING ON, LET ME ASK BARBARA
KELLY TO INTRODUCE HERSELF
BECAUSE I SEE SHE IS ON NOW.
BARBARA, WOULD YOU LIKE TO
INTRODUCE YOURSELF. NAME YOUR
AFFILIATION, IF YOU HAVE SERVED
ON A PREVIOUS COUNCIL.
>> THANK YOU VERY MUCH. BARBARA
KELLY, EXECUTIVE DIRECTOR OF THE
HEARING LOSS ASSOCIATION OF
AMERICA. I PREVIOUSLY SERVED ON
THE NATIONAL INSTITUTE ON
DEAFNESS AND OTHER COMMUNICATION
DISORDERS COUNCIL, THANK YOU.
>> GREAT, THANK YOU, BARBARA.
NOW BACK TO YOU, NICOLE.
>> THANK YOU VERY MUCH. OKAY. SO
NEXT WE ARE MOVING TO WORKING
GROUP RECOMMENDATION REPORTS.
FIRST WE HAVE THE NIH GENERALIST
REPOSITORY ECOSYSTEM INITIATIVE,
COUNCIL OF COUNCIL
RECOMMENDATION WORKING REPORTS.
PRESENTED BY DR. SUSAN
GREGURICK, AND COUNCIL OF
COUNCIL MEMBER DR. RAFAEL
IRIZARRY AT HARVARD. I WILL TURN
IT OVER TO SUSAN AND RAFAEL.
>> THANK YOU SO MUCH, NICOLE.
REALLY BIG THANKS TO MY
CO-CHAIR, DR. RAFAEL IRIZARRY
FOR THE WORKING REPORT WE WILL
PRESENT FOR YOUR CONSIDERATION.
NEXT SLIDE -- I WANT TO SET THE
STAGE BRIEFLY. OUR GENERALIST
INITIATIVE, THIS PROGRAM
SUPPORTS OUR GOALS TO ENHANCE
RESEARCHER'S ABILITY TO SHARE
DATASETS THAT UNDERLIE THEIR
RESEARCH AND THEIR PUBLICATIONS
AND ALIGNS WITH OUR GOALS TO
SUPPORT THE NIH FINAL DATA
MANAGEMENT AND SHARING POLICY.
SO THE NEXT SLIDE IS JUST A
LITTLE HISTORY ABOUT THIS
PROGRAM. SO THIS PROGRAM WAS THE
GENESIS OF A GROUND-BREAKING
WORKSHOP WE HELD IN 2020 THAT
WAS CO -CHAIREDED BY DR. MARION
MATONE AND DR. SHELLY STALL. WE
CONDUCT ED A PILOT ON THIS
CONCEPT OF THE GRAY REPOSITORY
INITIATIVE. THAT GROUND BREAKING
WORKSHOP LAID OUT CONCEPTS THAT
UNDERLIE THIS PROGRAM. FIRST AND
FOREMOST IS COMPETITION, WHERE A
VIBRANT REPOSITORY COMMUNITY
INCLUDING PARTICIPANTS FROM
INDUSTRY, ACADEMIA AND
GOVERNMENT CAN APPLY CONCEPTS OF
DETERMINING WHERE TO COMPETE AND
WHERE TO COLLABORATE. PUT THE
RESEARCHER AT CENTER, IMPORTANCE
OF RESEARCH ENGAGEMENT AND
NON-RESEARCHERS WOULD BENEFIT
FROM SHARING OF DATA AND
SERVICES ARE PART OF THIS DESIGN
OF THIS PROGRAM. FINALLY
SOFTWARES OF CONTEXT THAT NEEDS
TO INCENTIVISE METRICS AND
ENCOURAGE BEHAVIORAL CHANGE
AROUND DATA AND SOFTWARE SHARING
THAT PROVIDES TRANSPARENCY,
REUSABILITY AND REUSE. NEXT
SLIDE IS AN OVERVIEW OF GOALS
AND OBJECTIVE .
THE GOAL IS TO ENHANCE DATA
SHARING, ENHANCE GREATER
DISCOVABILITY AND SUPPORT
REPRODUCIBILITY AND PROVIDE A
LEARNING OPPORTUNITY . SO WE
(?) MODEL FOR BEST PRACTICES AND
ENSTANCIATED DATA ACROSS
REPOSITORIES LISTED, YOU SEE
THEM AT BOTTOM, STARTING WITH
(?) REPOSITORY ECOSYSTEM AND
PROVIDED LEARNING OPPORTUNITIES.
SO THE NEXT SLIDE IS A FEW OF
OUR NOTABLE OUTCOMES, INCLUDING
THE COMMENT IN META DATA FILES
AND METRICS IMPORTANT FOR BOTH
INSTITUTIONS AND FOR FUNDERS. WE
ARE ENSTANCIATING IDENTIFIERS
FOR RESEARCHERS AND OUTPUT AND
PRODUCE ENORMOUS AMOUNT OF
LEARNING MATERIALS YOU CAN SEE
CATALOGED HERE. THE NEXT SLIDE
INDICATES THE WORKING GROUP
CHARGE. COMPLETION OF THIS FIRST
INITIATIVE OF THIS PROGRAM WITH
THREE YEARS. WE CHARGE THE
WORKING GROUP GRAY COUNCIL
WORKING GROUPS TO PROVIDE AN
ASSESSMENT OF PROGRESS THAT HAS
BEEN DONE, TO DATE. FUTURE
RECOMMENDATIONS IF SO DESIRED
FOR THIS PROGRAM SO THEY
REVIEWED THE CURRENT SCOPE AND
GOALS AND LOOKED AT ALL THE
WORK, GRAY REPOSITORIES IN SOME
OF THE COMMUNITY, PROVIDED
RECOMMENDATIONS ON FUTURE OF
THIS INITIATIVE INCLUDING FUTURE
GOALS THAT WOULD BE BASED ON
PROGRESS THAT IS IMPORTANT FOR
BIOMEDICAL RESEARCH COMMUNITY'S
NEEDS. FINALLY, WE ASK THEM TO
GIVE US INDICATIONS OF WHAT
SUCCESS WOULD LOOK LIKE FOR THIS
INITIATIVE IN THE NEXT THREE
YEARS. THE NEXT SLIDE IS JUST A
HIGHLIGHT OF THE CHARGE. I WANT
TO THANK EACH AND EVERY ONE OF
OUR MEMBERS AND DR. IRIZARRY,
THANKS TO CASPER, RICK, CARLY,
JASON AND ALSO AMANDA WHO HELPED
ORGANIZE US, RUN MEETINGS AND
HELP ED WITH THE INITIAL DRAFT
OF THE REPORT. THE NEXT SLIDE IS
JUST HOW WE CONDUCTED OURSELVES.
WITH YOU WILL SEE WE HAD TEN
SESSIONS AND FOCUSED ON THE
THEMES, STARTING WITH COMMUNITY
ENGAGEMENT, META DATA METRICS
AND RESEARCH STORIES, PUTTING
RESEARCHERS AT THE FRONT. YOU
WILL HEAR THIS IN
RECOMMENDATIONS. WE SPENT A
NUMBER OF MOMENTS WRITING
REPORT. WITH THAT AND NEXTED
SLIDE I PASS OVER TO DR.
IRIZARRY, WHO WILL PROVIDE YOU
WITH THE REPORT, FINDING AND
RECOMMENDATIONS. THANK YOU, DR.
IRIZARRY, FOR YOUR WORK HERE.
>> THANK YOU, SUSAN. THANK YOU
FOR LISTENING AND ALL THE
MEMBERS THAT MADE WRITING THIS
REPORT FUN AND NOT THAT MUCH
WORK FOR ME. I WANT TO START BY
-- YOU CAN GO TO THE NEXT SLIDE.
I WANT TO START BY SUMMARIZING A
BIT OF WHAT SUSAN SAID, SO
EVERYBODY GETS AN IDEA HOW
IMPORTANT AND COST-EFFECTIVE
THIS WHOLE PROJECT IS. SO WHEN
THOSE OF YOU WHO WORK IN AREAS,
ME FOR EXAMPLE IN GENOMICS, WE
ARE USED TO HAVING THESE WHERE
WE CAN PUT OUR DATA AND ALL
FIGURED OUT AND YOU KNOW WHAT TO
DO, REQUIRED TO PUBLISH. BUT
THERE'S MANY OTHER AREAS OF
BIOMEDICAL THAT DON'T HAVE SUCH
REPOSITORIES. THE IDEA IS TO
OFFER A PLACE FOR PEOPLE TO BE
ABLE TO SHARE THEIR DATA. NOW IT
IS REQUIRED BY THE NIH, WHEN
THERE AREN'T ALREADY SPECIALIZED
REPOSITORIES. SO THAT IS NOT --
THAT IS JUST AN INTRODUCTION TO
MOTIVATION FOR THIS. BUT THEN
WHAT THE IDEA OF THIS GRAY
INITIATIVE IS TO MAKE IT SO THAT
WHEN PEOPLE SUBMIT DATA, IT
MAKES IT -- THERE IS SOME
SYSTEMATIC ORGANIZATION. IT IS
NOT JUST THROWING STUFF UP AND
JUST TO SATISFY SOME
REQUIREMENTS. SO IN PARTICULAR,
IF WE LATER WANT TO REUSE THE
DATA -- THAT IN PART WHAT THIS
COMMITTEE IS -- THIS INITIATIVE
IS ABOUT. YOU WANT PEOPLE TO
SHARE DATA AS REQUIRED. ONE OF
THE REASONS WE DO THAT, IN THE
OPINION OF THE COMMITTEE, THIS
IS THE MAIN RECOMMENDATION,
INSTEAD OF ALL MOTIVATIONS, THE
MAIN ONE AND WE SHOULD BE
FOCUSED ON IS THIS FACILITATING
DATA REUSE SO WE SPEND LOT OF
MONEY ON THESE DATA SETS.
THERE'S PROBABLY A LOT MORE
INFORMATION THAT WAS PUBLISHED
BY THE ORIGINAL GENERATORS. YOU
CAN COMBINE DATA SETS TO
GENERATE NEW INSIGHTS. BUT THAT
IS NOT EASY TO FIND DATA AND PUT
IT ALL TOGETHER. THAT IS WHAT WE
-- PART OF WHAT THIS INITIATIVE
IS ABOUT. THAT IS WHAT WE WANT
TO FOCUS ON. WHAT WE WANT THE
NEXT VERSION OF THIS INITIATIVE
TO MAKE THE MAIN PRIORITY, MAKE
DATA REUSE EASIER AND DOABLE. SO
THAT -- THERE IS ALSO -- THERE'S
OTHER IMPORTANT ASPECTS THAT
ALSO SHOULD BE -- CONTINUE TO BE
PRIORITIZED. QUANTIFYING IMPACT.
WE WANT THIS (AUDIO DIFFICULTY)
REDONE SO WE WANT THAT TO BE
MORE OF A PRIORITY. THEN THE
OTHER -- MAIN RECOMMENDATION IS
THE FIRST CYCLE OF THIS, THERE
WAS A LOT OF THOUGHT THAT WAS
PERHAPS MORE THEORETICAL AND
THINKING OF PRINCIPLES AND
GETTING THINGS STARTED. ONE OF
THE THINGS WE FOUND IS THERE
DOESN'T SEEM TO BE THAT MUCH
ENGAGEMENT IN USING DATA. WE
WANT MORE. THAT IS ANOTHER MAIN
RECOMMENDATION. THE NEXT SLIDE.
YEAH, O THIS IS WHAT I
DISCUSSED, THE FOCUS, THE MAIN
FOCUS WOULD BE REUSE OF FOCUS SO
THAT MAKING THE DATA EASY TO
FIND AND MAKE IT -- THINK HARD
ABOUT THE CAPABILITIES FOR
SEARCHING. THIS IS IN THE REPORT
WE TALK A LOT ABOUT THIS. IF YOU
WANT TO LEARN MORE. BUT THIS IS
ACTUALLY QUITE A COMPLEX
CHALLENGE. HOW DO YOU MAKE DATA
FINDABLE AND MAKING IT SO THAT
PEOPLE LOOKING FOR DATA THAT
THEY MIGHT NOT KNOW ARE
AVAILABLE, HOW DO YOU DO THAT?
WHAT TOOLS CAN THEY DEVELOP TO
MAKE IT EASY TO FIND. SAY ALL
THE DATA SETS RELATED TO THE
SPECIFIC TOPIC YOU ARE
INTERESTED IN STUDY. NEXT SLIDE.
SO SOME OF THE OTHER
RECOMMENDATIONS WITH EXPANDING
ENGAGEMENT WITH THE BIOMEDICAL,
THESE ARE THINGS ARE LOOKING
FOR. MAKE IT MUCH MORE
PRACTICAL. ALSO TO ENGAGE WITH
OTHER REPOSITORIES, THERE IS A
LOT OUT THERE. AND SOME WERE
CONCERNED THERE WASN'T ENOUGH
COMMUNICATION WITH WHAT IS
ALREADY WORKING WITH THE MORE
MATURE REPOSITORIES,
DOMAIN-SPECIFIC REPOSITORIES
THEN TO CONTRIBUTE TO FAIR
METHODS AND APPROACHES,
ESTABLISH A STEERING COMMITTEE
FROM THE COMMUNITY, FROM THE
PEOPLE THAT ARE GOING TO USE
THIS. NEXT SLIDE. SO AGAIN, THE
METRICS FOR QUANTIFYING IMPACT
ON BIOMEDICAL DATA, WE WANT THEM
TO FOCUS, IMPACT IN CASE
STUDIES. WE -- THERE WERE SOME
CASE STUDIES BUT I THINK IN THE
NEXT GENERATION THERE SHOULD BE
MANY MORE SUCCESS STORIES OF
PAPERS BY OBTAINING DATA FROM
THESE GENERALIST REPOSITORIES.
THEN ALSO THE FOCUS ON THE
UNIVERSAL ADOPTION OF DATA
CITATION AND LINKING TO
PUBLICATIONS. THIS RELATES TO MY
EARLIER COMMENTS ABOUT
INCENTIVISING THE SHARING OF
DATA. THIS IS SOMETHING THAT A
LOT OF -- IT IS NOT JUST THIS
GROUP THAT IS THINKING ABOUT IT
SO WE ARE RECOMMENDING THEY
IDENTIFY PARTNERS TO DEVELOP
METRICS WITH. IT SHOULDN'T JUST
BE THIS SMALL ISH GROUP. THIS IS
A BIGGER CHALLENGE THAT I THINK
A LOT OF PEOPLE ACROSS THE NIH
ARE WORKING ON. THE NEXT SLIDE.
SO BEFORE I TURN IT OVER TO Q &
A, ONE OF THE THINGS I LEARN BY
WORKING ON THIS REPORT IS THAT
THIS IS -- AS YOU HEARD ME SAY,
SOMETHING I THINK IS VERY
IMPORTANT TO HAVE THIS
CAPABILITY OF NOT JUST A PLACE
FOR PEOPLE TO SHARE DATA BUT
MAKE IT SO THAT IT IS REUSABLE.
OTHERS CAN FIND IT AND USE IT.
THIS PARTICULAR INITIATIVE IS
ACTUALLY PRETTY SMALL, THE
FUNDING IS SMALL SO THAT I ENDED
UP BEING CONVINCED THE RETURN ON
INVESTMENT IS GOING TO BE -- CAN
BE QUITE LARGE. ALL RIGHT. THAT
IS ALL I HAVE TO SAY. WE ARE
HAPPY TO TAKE QUESTIONS.
>> THANKS SO MUCH. BEFORE WE
START WITH QUESTIONS, I WANT TO
REMIND MEMBERS OF OUR PROCESS
FOR WORK GROUP REPORTS. SO THE
COUNCIL DOES NOT EDIT THE REPORT
AND ITS RECOMMENDATIONS. WE ARE
ASKING FOR YOUR YES OR NO VOTE
ABOUT WHETHER YOU CONSIDER THE
WORK GROUPS, WORK PROCESS, WHAT
IS ADEQUATE AND RECOMMENDATIONS
ARE SOUND. YOU CERTAINLY CAN
ELECT TO CONVEY ADDITIONAL VIEWS
FROM COUNCIL IN A MEMO THAT I
WILL WRITE REPRESENTING YOU TO
DR. B. AS HE CONSIDERS TO
RESPOND SO A REMINDER. I SEE
QUESTIONS AND FOLKS RAISING
THEIR HANDS SO I WILL TURN IT
OVER TO FRANZISKA TO GO THROUGH
AND ASK FOLKS TO UNMUTE.
>> I SEE ROSS YOU HAVE RAISED
YOUR HAND FIRST. GO AHEAD.
>> I WANT TO THANK RAFAEL AND
SUSAN FOR PUTTING THIS TOGETHER.
SO IMPORTANT, SO TIMELY. A
QUESTION IN THE COMMENT. THE
QUESTION IS IN THINKING ABOUT
WHAT IS A LARGE SHAREHOLDER
DATASET WAS THERE CONSIDERATION
GIVEN TO REGISTRATION PROCESS
FORMALIZED BY THE NIH SIMILAR TO
CLINICAL TRIALS.GOV, TO ALLOW AT
LEAST CATALOGING WHAT CREATES A
DATA SET AND REPOSITORY FOR
PEOPLE TO FIND THESE DATA SETS?
>> I CAN TAKE A STAB AT THAT, IF
YOU LIKE, AND OTHERS. I THINK
THAT IS AN EXCELLENT CONCEPT AND
QUESTION. WHAT IS HAPPENING AT
THE NATIONAL LIBRARY OF
MEDICINE, WHICH I THINK WE CAN
EXPAND ON AND REPOSITORIES
PARTICIPATE, WHICH IS
ESSENTIALLY A META DATA
REGISTRATION AND CATALOG SUCH
THAT ALL FUNDED BY NIH, OR MAYBE
JUST BIOMEDICAL DATA SETS ARE
CATALOGED THROUGH META DATA AND
LINKED OUT THROUGH THE
REPOSITORY, THIS PROVIDES
OPPORTUNITY FOR THE NLM TO
DISCOVER DATA AND GO TO
REPOSITORY WHERE THEY CAN OBTAIN
THE DATA. IT IS A COST-EFFECTIVE
WAY OF SEARCHING, DISCOVERING
AND SHARING DATA IN THAT THESE
REPOSITORIES ARE EITHER FUNDED
BY NIH OR OTHER ENTITIES. THE
GRAY INITIATIVE REPOSITORIES ARE
NOT FUNDED BY NIH BUT THE
COLLABORATION AND COOPERATION
CONCEPTS IS WHAT WE FUND. SO
THAT IS THE MODEL. I THINK WE
COULD BUILD OUT ON THAT. I LOVE
THE CONCEPT AND WOULD LIKE TO
SEE THAT ENSTANCIATED AT SCALE.
>> THAT IS PART OF WHAT WE ARE
LOOKING FOR WHEN WE RECOMMEND WE
GET MORE FEEDBACK FROM THE
COMMUNITY. AS SUSAN EXPLAINED
YOU CAN DEPOSIT A DATA SET ON
ANY OF THESE. NIH HAS NOTHING TO
DO WITH THAT. THAT IS SOMETHING
YOU CAN DO. SOME ARE FREE.
DEPOSIT PRETTY BIG STUFF WITHOUT
PAYING. BUT ONCE YOU DO THAT,
HOW PEOPLE FIND IT. IT IS
IMPOSSIBLE UNLESS THEY GO TO
YOUR PAPER AND SEE THE LINK.
OTHERWISE IT IS HARD. ONE OF THE
POINT S IS TO HAVE META DATA TO
MAKE IT FINDABLE. WHAT WE HAVE
FOUND IS THAT LIKE I SAID
EARLIER, THERE IS SOME WORK AND
ADAPTATION OF IDEAS PUT OUT TO
MAKE THINGS FINDABLE BUT WE WANT
TO SEE MORE PRACTICAL SOLUTIONS
TO ANSWER QUESTIONS JUST LIKE
YOURS.
>> GREAT. I'M GLAD THIS IS BEING
CONSIDERED. I WOULD REALLY URGE
THE GROUP, ESPECIALLY THE VLM
GROUP TO COME UP WITH CRITERIA
FOR WHAT CONSTITUTES A DATA
SOURCE OR DATA SET AND ENFORCE
THAT SIMILAR TO WHAT'S HAPPENED
WITH CLINICAL TRIALS IN CLINICAL
TRIAL.GOV SHOWING YOU HAVE TO
MEET CERTAIN CRITERIA, LIKE IRB
APPROVAL TO HAVE A STUDY. THE
COMMENT IS, JUST TO MAKE THE
LARGER COMMUNITY AWARE OF A
CHALLENGE THAT ORIGINATE ED FROM
THE EYE INSTITUTE AND MIKE
CHANG, THE DIRECTOR, THE S.
INDEX CHALLENGE. THIS IS OPEN.
NOW IT IS ACTUALLY CLOSING VERY
SHORTLY I THINK THE END OF THIS
WEEK. I WILL PUT THE LINK IN THE
COMMENTS TO REED FROM THE
ANNOUNCEMENT. THIS IS A
CHALLENGE TO INCENTIVISE AND
REWARD DATA SHARING BY PROMOTING
A NEW METRIC THAT WILL ASSESS
HOW EFFECTIVELY RESEARCHERS
SHARE DATA. IT WILL INCLUDE THE
VALUE OF SHARE DATA INCLUDING
COMPLIANCE WITH FAIR PRINCIPLE,
TIMELINESS WITH WHICH DATA IS
SHARED, COMPLETE LESS OF META
DATA, FREQUENCY WHICH SHARED
DATA IS U UTILIZED AS WELL AS
INFLUENCE OF SHARED DATA ON
SHARED PUBLICATION AND PATENTS.
I ENCOURAGE THE GROUP TO
COORDINATE WITH NEI IN EFFORTS
TO TRY TO DEVELOP A METRIC FOR
IMPACT COMPARABLE TO WHAT YOU
ARE DISCUSSING, RAFAEL, TO
DETERMINE HOW EFFECTIVE A DATA
SET IS.
>> ANYTHING TO WORK WITH OTHERS
AND IMPLEMENT WHAT ARE -- IF
THERE ARE -- THINGS THAT ARE
IMPLEMENTED TO USE THAT.
>> THANK YOU FOR THAT QUESTION.
WE ALSO SAW SUSAN'S COMMENT IN
THE CHAT AS WELL. THANK YOU,
RAFAEL, AND SUSAN FOR THE
RESPONSE. YOU HAVE THE NEXT
QUESTION.
>> SO THANKS VERY MUCH. GREAT
WORK TO THE WORKING GROUP. I DO
HAVE TWO QUESTIONS REGARDING IF
THE WORKING GROUP ACTUALLY
DISCUSSED THESE TWO THINGS. I'M
ASKING BECAUSE, YOU KNOW, WE
HAVE BEEN ASKED TO SHARE DATA
FOR MANY, MANY YEARS. THERE HAVE
BEEN MANY POLICIES FROM NIH
SAYING HOW TO SHARE DATA AND ALL
THAT. YET WHAT I FIND LACKING IS
NOT SO MUCH THE SHARING OF DATA,
OR YES, WE COULD ALWAYS DO
BETTER. BUT ON THE OTHER END.
THE PERSON WHO IS THEN GOING TO
USE THAT DATA THAT WAS SHARED BY
SOMEONE ELSE. SO MY QUESTIONS
THEN ARE DID THE WORKING GROUP
TAKE UNDER CONSIDERATION THE
FACT THAT THERE IS A NEED FOR
CURATION OF DATA COMING FROM
MULTIPLE SOURCES THAT, YOU KNOW,
EVEN SOMETHING AS SIMPLE AND
DOWN TO THE LEVEL OF IT IS IN
MILLIGRAMS OR MIL EQUIVALENTS IN
TERM OS TESTIFY
REPORT .ENTERIF YOU DON'T HAVE
THAT CURATED IT IS IMPOSSIBLE AS
USERS TO ACTUALLY USE THAT DATA.
DID YOU ADDRESS CURATION, NUMBER
ONE. NUMBER TWO, DR. IRIZARRY,
YOU SAID THERE WILL BE A GREAT
RETURN ON INVESTMENT IN THIS. SO
WITH REGARD TO THAT AND WITH
REGARD TO THE DEVASTATING
SHRINKING OF THE NIH BUDGET,
WHAT DID THE GROUP TALK ABOUT,
WHAT INVESTMENT WILL BE NEEDED.
BECAUSE OF THE REDUCED NIH
BUDGET PROPOSED, WHAT YOU
BELIEVE IS WORTH GIVING UP IN
ORDER TO PAY FOR THIS EFFORT.
THANKS VERY MUCH.
>> SO TO ANSWER YOUR FIRST
QUESTION, THAT WAS PERHAPS THE
THING WE DISCUSSED THE MOST
EXACTLY. YOUR EXAMPLE IS VERY
SIMILAR TO ONE THAT WE WERE
GOING TO DISCUSS MANY OTHERS.
THAT IS PART OF THE
RECOMMENDATION IS TO FOCUS ON
PRACTICALITY AS YOU DESCRIBED. A
RE-USER CAN ACTUALLY DO
SOMETHING WITH THIS. THAT IS ONE
THING I LEARNED FROM LISTENING
TO THE PEOPLE CURRENTLY INVOLVED
IN INITIATIVE THAT THAT IS A
PRETTY HARD PROBLEM WHEN YOU
HAVE A GENERALIST REPOSITORY,
ACTUALLY QUITE HARD. UNLIKE THE
DOMAIN-SPECIFIC ONES WHERE YOU
CAN BE VERY SPECIFIC ABOUT WHAT
YOU NEED TO INCLUDE, HERE IT IS
A LITTLE BIT -- A LITTLE HARDER.
BECAUSE THERE'S MANY DIFFERENT
DATA SETS FROM DIFFERENT AREAS
OF BIOMEDICAL RESEARCH. THAT WAS
ATTENTION WHEN WE DISCUSS ED IN
THE COMMITTEE. THERE WAS SOME
THAT THOUGHT THERE SHOULD FOCUS
MORE ON MAKING IT -- FOCUSING ON
MAYBE THE 80% THAT CAN BE MADE
SPECIFIC. OTHERS THAT THOUGHT
NO, THIS IS A GENERAL
REPOSITORY, THE WHOLE POINT IS
KEEP IT GENERAL. BUT IT IS IN
THERE, IN THE REPORT. YOU CAN
SEE THAT RELATES TO THE FIRST
RECOMMENDATION. IS THAT FOCUS ON
MAKING THE DATA -- MAKING IT
REUSABLE. THAT SHOULD BE THE
VERY PRACTICAL FOCUS AND IN
PARTICULAR USABLE BY THE
BIOMEDICAL RESEARCH COMMUNITY.
TO YOUR SECOND QUESTION, MAYBE
SUSAN, YOU CAN SAY MORE ABOUT
THIS BUT WE WEREN'T CHARGED WITH
DISCUSSING BUDGETS. WE WERE
CHARGED WITH DISCUSSING
RECOMMENDATIONS BASED ON WHAT
THE MISSION OF THE INITIATIVE
IS.
>> YEAH, THAT IS CORRECT. WE DID
NOT CHARGE THEM TO RECOMMEND A
PARTICULAR BUDGET LEVEL BECAUSE
THERE ARE MANY PRIORITIES OF THE
NIH AND NIH DIRECTOR THAT WOULD
BE TAKEN INTO CONSIDERATION. THE
STRATEGIC PLAN FOR DATA SCIENCE
AND REISSUE , THE NUMBER ONE
ACTIVITY WE HEARD FROM THE
COMMUNITY AND FROM OUR NIH
LEADERSHIP WAS TO FOCUS AND
SUPPORT THE NIH DATA MANAGEMENT
AND SHARING POLICY WITH REAL (?)
AND WORK THAT WOULD ENABLE THE
COMMUNITY TO CREATE AND USE DATA
SO THAT RESEARCH IS
REPRODUCIBLE. I SEE THAT ECHOING
AS A STRONG PRIORITY, GOING
FORWARD. I THINK WE WILL TAKE
THIS UNDER CONSIDERATION AS WE
PLAN FOR PROGRAMS IN FY26.
>> THANKS. I HOPE YOU WILL BRING
BACK MAYBE IN A YEAR TO US HOW
YOUR EFFORTS HAVE PROGRESSED AND
WHAT CHALLENGES YOU ARE FINDING
AND MAYBE PROVIDE SUGGESTIONS,
THANKS.
>> WOULD LOVE TO DO THAT.
>> GREAT.
>> SO I DON'T SEE ANYMORE
QUESTIONS. I'M SEEING WE CAN GO
TO THE VOTE, IN THAT CASE. YOU
REMEMBER FROM THE LAST MEETING
WE WILL DO THE RAISED HAND
VOTES. PLEASE REMEMBER ONLY
COUNCILMEMBERS CAN VOTE. I WILL
ASK FOR A MOTION AND SECOND TO
BE ENTERED INTO THE CHAT BY TWO
COUNCILMEMBERS. THEN I WILL ASK
FOR DISCUSSION AND THEN ASK FOR
A VOTE. SO LET ME START. MAY I
HAVE A MOTION TO ACCEPT, AS
WRITTEN, THE REPORT -- THE
GENERALIST NESH TIF --
INITIATIVE OR WORKING GROUP OF
COUNCIL OF COUNCILS. I HAVE TO
SWITCH OVER. I SEE SO MOVED AND
ALSO SEE SECONDED. THANK YOU
VERY MUCH. IS THERE ANY
ADDITIONAL DISCUSSION ON THIS
MOTION?
>> THANK YOU, DOCTOR. THIS IS TO
ACCEPT AS WRITTEN REPORT OF
GENERALIST REPOSITORY ECOSYSTEM
INITIATIVE GRAY WORKING GROUP OF
THE COUNCIL OF COUNCIL. AS
REMINDER ONLY COUNCILMEMBERS
SHOULD PARTICIPATE. PLEASE RAISE
YOUR HAND TO VOTE AYE. THANK
YOU. I SEE NINE HANDS. PLEASE
LOWER ALL HANDS. THANK YOU SO
MUCH. PLEASE RAISE YOUR HAND TO
VOTE NAY. NOT SEEING ANY HANDS.
MOVING ALONG. PLEASE RAISE YOUR
HAND TO VOTE ABSTENTION. NOT
SEEING ANY HANDS. THIS CONCLUDES
THE VOTE. THE MOTION, AS STATED,
HAS PASSED.
>> THANK YOU, CHRISTINA AND
STAFF. WE ARE ALMOST PERFECTLY
ON TIME. BACK TO YOU.
>> I DO JUST WANT TO FOLLOW UP
AND ASK IF THERE ARE ANY
ADDITIONAL VIEWS THAT COUNCIL
WOULD LIKE TO CONVEY WITH THE
REPORT. I WOULD ASK IF THERE
ARE, IF YOU COULD PUT THEM IN
THE CHAT, THAT WOULD BE VERY
HELPFUL. I WILL ALSO NOTE THAT
WE ARE WORKING ON DRAFTING
RESPONSES TO SOME OF THE
QUESTIONS THAT WERE RAISED
DURING THE PREVIOUS SESSION FROM
DR. MANLEY AND OTHERS REGARDING
SOME OF THE AWARDS AND COUNCIL
MEMBERSHIP. WE WILL FOLLOW UP
LATER WITH ADDITIONAL
INFORMATION TO ADDRESS THOSE
QUESTIONS. OKAY. MOVING TO OUR
NEXT AGENDA ITEM, THIS IS THE
NIH AIM-AHEAD PROGRAM COUNCIL OF
COUNCIL'S REPORT. PRESENTED BY
SUSAN. AGAIN, THANK YOU, SUSAN.
YOU HAVE LOTS OF WORK. COUNCIL
OF COUNCIL'S MEMBER DR. KAREN
JOHNSTON, THE DISTINGUISHED
PROFESSOR OF NEUROLOGY AND
CLINICAL RESEARCH AT UNIVERSITY
OF VIRGINIA SCHOOL OF MEDICINE
AND DR. JEAN KING, DEAN OF ARTS
AND SCIENCES AND PROFESSOR OF
NEUROSCIENCE, BIOLOGY AND
BIOTECHNOLOGY AT WORCESTER
POLYTECNIC INSTITUTE.
>> I WILL KICK OFF. IT WAS A
WONDERFUL YEAR WORKING WITH BOTH
GROUPS. NOW THE AIM-AHEAD AND
YOU WILL HEAR OUR WORKING GROUP
REPORT. I WANT TO THANK KAREN
AND JEAN FOR DEDICATED HARD WORK
ON THIS REPORT. IT WAS A DELIGHT
TO WORK TOGETHER. THE NEXT SLIDE
IS JUST A LITTLE BIT OF AN
OVERVIEW OF THE PROGRAM. SO THE
AIM-AHEAD PROGRAM INITIATED BY
NIH AIMS TO ENHANCE THE USE OF
ARTIFICIAL INTELLIGENCE AND
BIOMEDICAL RESEARCH IN CLINICAL
SETTINGS BY BUILDING
PARTNERSHIPS THAT SUPPORT
INFRASTRUCTURE AND RESEARCH AND
MENTORSHIP AND TRAINING.
PRIMARILY IN UNDERRESOURCED
COMMUNITIES. THIS HAD A
WHIRLWIND TOUR, A FUNDING
ANNOUNCEMENT IN JULY OF 2021 AND
MADE THE FINAL AWARDS
SEPTEMBER 17TH OF 2021 SO QUITE,
QUITE FAST. THE MAIN IS DR. V.,
PROFESSOR AT UNIVERSITY OF NORTH
TEXAS HEALTH SCIENCE CENTER IN
FORT WORTH, TEXAS. THE ENTIRE
PROGRAM AND GOVERNANCE, I DON'T
WANT TO GO THROUGH THE WHOLE
FIGURE BUT HIGHLIGHT A FEW
IMPORTANT FACTS YOU REALLY NEED
TO KNOW .
THE FIRST IS FUNDING MECHANISM
IS OTHER TRANSACTIONAL
AUTHORITY, NEITHER A CONTRACT OR
GRANT BUT SORT OF PARTNERSHIP
BETWEEN AWARDEE AND NIH. IT IS
BROKEN INTO ADMINISTRATIVE,
INFRASTRUCTURE, DATA AND
TRAINING COURSE. THOSE ARE
FUNDED THROUGH THE SUBAWARDS OF
THE MAIN OTA TO (?). THE AWARD
INCLUDES IDENTIFYING FOUR NORTH
STARSLY IDENTIFY AND HELP FOCUS
ENTIRE PROGRAM AND ALL SO WE ARE
ALL MARCHING TOGETHER. AND
IMPORTANTLY THIS PROGRAM IS
NATIONWIDE AND STRUCTURED WITH
SEVEN HUBS. THAT HELPS US PUT
PROGRAMS AND INITIATIVES AND
COLLABORATIONS ACROSS THE
COUNTRY. THOSE ARE INITIATED
THROUGH THE HUB STRUCTURE. SO
THE NEXT SLIDE, JUST REALLY
ILLUSTRATES THE GOALS AND NORTH
STAR. THE GOALS ARE
PARTICIPATION OF RESEARCHERS AND
COMMUNITIES AND STAKEHOLDERS AND
ARTIFICIAL INTELLIGENCE AND
PARTICIPATION BY THOSE THAT MAY
NOT NECESSARILY BE FIRST THOUGHT
IN DEVELOPING AND USING AI.
FOCUSING ON HEALTH CHALLENGES
AND DISPARITIES AND BEHAVIORAL,
MENTAL, METABOLIC, CARDIO,
RESEARCH AND OUTCOMES USING
INTELLIGENCE, MACHINE LEARNING
AND, IMPORTANTLY, TO BRING THE
CAPACITY THAT ARTIFICIAL
INTELLIGENCE OFFERS THROUGH THIS
ENABLING TECHNOLOGY ACROSS
UNITED STATES. THE FOUR NORTH
STARS THAT DRIVE THIS PROGRAM
ARE TO DEVELOP A BROAD TALENT
SET OF NEW AI AND WORKFORCE, TO
INCREASE KNOWLEDGE AND AWARENESS
OF THIS AT A NATIONAL SCALE BY
ENGAGING EMPOWERMENT IN
ARTIFICIAL INTELLIGENCE, TO USE
THAT TO IMPROVE HEALTH AND WE
HAD A PARTICULAR FOCUS ON CARDIO
METABOLIC CANCER COMMUNITIES
BECAUSE THIS IS WHAT THE
COMMUNITIES TOLD US THEY WANTED
US TO WORK ON. TO BUILD THAT
INFRASTRUCTURE AND CAPACITY TO
WORK WITH COMMUNITIES, MEET
WHERE THEY ARE AND HELP DEVELOP
THAT INFRASTRUCTURE. BECAUSE
THERE IS NO ONE-SIZE-FITS ALL
THAT WILL WORK ACROSS OUR
NATION. SO WE DID MEET WITH THE
COMMUNITIES TO HELP DEVELOP THE
INFRASTRUCTURE FOR THEM. THE
NEXT SLIDE IS GOING TO BE THE
HIGHLIGHTS. I CAN'T POSSIBLY
DISCUSS ALL. I WILL HIGHLIGHT A
FEW. JUST THE NOMENCLATURE WHEN
YOU SEE NS1, THAT MEANS NORTH
STAR ONE SO NS4 WOULD BE NORTH
STAR FOUR. SOME OF THE
HIGHLIGHTS. FOR EXAMPLE THIS
ENGAGES OVER 650 RESEARCHERS AND
I THINK ALMOST A THOUSAND
INSTITUTIONS ACROSS THE COUNTRY.
WE ALSO LEVERAGE EXISTING
PROGRAMS AT NIH TO HELP WITH OUR
TRAINING, OUR DATA AND
CAPACITY-BUILDING. SO, FOR
EXAMPLE, WE HAVE STRONG
COLLABORATIONS WITH THE ALL OF
US, NCADS COVID CLINICAL COHORT
COLLABORATIVE, WITH BRIDGE TO AI
AND SHARED PLATFORM SUPPORTED BY
NIMHD. WE SUBSTANTIATE
PUBLIC-PRIVATE PARTNERSHIPS,
OCHEN AND MEDSTAR. I WANT TO
HIGHLIGHT ONE PARTNERSHIP FOR
ME, IN PARTICULAR, IS
PARTNERSHIP WITH AMERICAN INDIAN
HIGHER EDUCATIONAL CONSORTIUM TO
DEVELOP AI CURRICULUM WITH 22
TRIBAL COLLEGES AND
UNIVERSITIES. THIS IS A SNAPSHOT
OF SOME OF THE IMPACTS OF THIS
PROGRAM. THE NEXT SLIDE IS THE
CHARGE.LY READ THE CHARGE AND
HAND OFF TO MY COLLEAGUE, KAREN.
SO WE CHARGE THIS GROUP IN APRIL
OF 2024 TO REVIEW THE CURRENT
SCOPE AND GOALS OF THE AIM-AHEAD
PROGRAM, ASSES THE PROGRESS TO
DATE. BASED ON THIS, TO MAKE
RECOMMEND
RECOMMENDATIONS, LIKE THE OTHER
WORKING GROUP, TELL US WHAT YOU
THINK SUCCESS OF THIS PROGRAM
WOULD MEAN SO WE CAN MEET YOUR
DESIRED GOALS. WITH THAT, I'M
GOING TO HAND OVER TO KAREN SO
WE CAN MOVE FORWARD ON THE
PROCESS.
>> GREAT. THANK YOU, SUSAN. SO I
JUST WANTED TO MAKE SURE THE
COUNCIL HAD A LITTLE SENSE OF
THE PROCESS THAT WE USED. WE
STARTED BY IDENTIFYING EXPERTS
ACROSS THE COUNTRY AND BRINGING
THEM TOGETHER, MEET MONTHS AGOLY
SINCE OCTOBER OF 2024. WE SPENT
MOST TIME MEETING WITH MEMBERS
OF THE AIM-AHEAD TEAM SO MET
WITH LEADERSHIP, TRAINEE, AWARD
DEE, STAKEHOLDERS AND PANEL
MEMBERS. IN EACH OF THESE
MEETI
MEETINGS, WE TALKED WITH TEAM
MEMBERS ABOUT THEIR PERCEPTION
OF KEY SUCCESSES WERE, WHAT
THEIR CHALLENGES WERE, WHAT
THEIR RECOMMENDATIONS WOULD BE
IN TERMS OF THE FUTURE OF
AIM-AHEAD. ALL THAT INFORMATION
WE USED TO DEVELOP THE DETAILED
REPORT, WHICH YOU HAVE AND OUR
HOPES THIS WILL INFORM THE NEXT
ITERATION OF AIM-AHEAD. NEXT
SLIDE, PLEASE. SO THIS IS OUR
EXPERT TEAM. WE ARE INCREDIBLY
GRATEFUL TO EACH FOR THEIR
INSIGHTS AND THEIR TIME. NEXT
SLIDE, PLEASE. SO WE WANTED TO
MAKE SURE THE COUNCIL HAS A
SENSE OF THE DREAD -- BREADTH OF
THE NETWORK. THIS IS A MAP
ACROSS THE COUNTRY. YOU CAN SEE
ON THE MAP THE DIFFERENT COLORS
IN THE STATES. THOSE REPRESENT
THE SEVEN REGIONAL HUBS. THEN
THE RED DOTS ARE MENTEES AND
BLUE ARE MENTORS. YOU CAN SEE
HOW WELL DISTRIBUTED THEY ARE
ACROSS THE HUBS AND ACROSS THE
NATION. WE ALSO LOOK AT
COMMUNITY STAKEHOLDER MAPS AND
AWARDEE MAPS AND THOSE ARE
DISTRIBUTED ACROSS HUBS AND
COUNTRY. NEXT SLIDE, PLEASE. SO
WE WANTED TO GIVE THE COUNCIL A
LITTLE BIT OF A HIGH-LEVEL SENSE
OF WHAT OUR MAJOR FINDING WERE.
I WILL TELL YOU THAT WE WERE ALL
VERY MUCH IMPRESSED WITH THE
FACT THAT AIM-AHEAD HAD BUILT A
NATIONAL AI MACHINE LEARNING
HEALTH RESEARCH ECOSYSTEM. YOU
CAN SEE IN THAT IMPACT BOX ON
THE SLIDE THAT THERE WERE OVER
7,000 MEMBERS, OVER 4,000 MEANT
MENTEES, 2,000 MENTORS AND 2,000
INSTITUTIONS INVOLVED THAT WAS
BUILDING COLLABORATION. WE ALSO
IDENTIFIED THERE WAS A -- THEY
HAD BUILT A PROFESSIONAL
DEVELOPMENT ECOSYSTEM. THEY USED
A TOOL CALLED AIM-AHEAD CONNECT,
WHICH HOUSES ALL OF THE TRAINING
MATERIALS AND CONFERENCES,
SYMPOSIUM MATERIALS THAT ARE NOT
ONLY AVAILABLE TO THE AIM-AHEAD
PARTICIPANTS BUT HAD MADE IT
AVAILABLE BY REGISTRATION FOR
ANYONE WHO WANTS TO REGISTER AND
VIEW THOSE MATERIALS
ASYNCROUNUSLY AND TO NETWORK.
THEY HAVE DEVELOPED
APPROXIMATELY 400 AI-READY
RESEARCH WORK FORCE MEMBERS WE
STRONGLY BELIEVE WILL SUPPORT
THE SUSTAINABILITY OF THE IMPACT
THEY CAN HAVE. NEXT SLIDE,
PLEASE. SO ONE OF THE THINGS WE
TALK ABOUT IN EVERY SINGLE ONE,
A COUPLE OF THE COMPONENTS THAT
WE FELT WERE REALLY IMPACTFUL IN
TERMS OF CREATING A SUSTAINABLE
INFRASTRUCTURE. THE FIRST WAS
THEY DEVELOPED A FED RATED
NETWORK, WHICH ALLOWED FOR
COLLABORATIVE DATA ANALYSIS
WITHOUT THE INSTITUTIONS OR
ORGANIZATIONS HAVING TO SHARE
THEIR PATIENT-LEVEL DATA OUTSIDE
OF THEIR OWN FIREWALL. THEY
CREATED A REGULATORY COMPLIANCE
OFFICE, WHICH FUNCTIONED ALMOST
LIKE A REGULATORY CONCIERGE TO
HELP MEMBERS GET THROUGH THOSE
REGULATORY PIECES MORE QUICKLY
AND EFFICIENTLY SO THEY COULD
GET TO THEIR RESEARCH PROJECTS.
THEY WERE VERY INTENTIONED ABOUT
BUILDING CAPACITY IN THE TRIBAL
COMMUNITY SAFETY NET HOSPITALS
COMMUNITY HEALTH CENTERS.
FINALLY, THEY DEVELOPED A
DURABLE REAL-WORLD DATA AI
TRAINING CURRICULUM ALREADY
BEING SHARED WITH ALL OF US,
WITH NCATS AND BRIDGE TO AI.
EACH OF THESE COMPONENTS ARE
ONLY SOME BUT THINGS WE THOUGHT
REALLY SUPPORTED THE
SUSTAINABILITY OF THE PROGRAM.
WITH THAT I'LL PASS IT AHEAD TO
DR. KING TO TALK ABOUT OUR
RECOMMENDATIONS.
>> THANK YOU VERY MUCH. THANKS
TO THIS GROUP. IT WAS A
WONDERFUL GROUP TO WORK WITH.
NEXT SLIDE, PLEASE. SO AS IN
EVERY ORGANIZATION AND EVERY
GREAT PROJECT LIKE THIS ONE,
THERE ARE CHALLENGES. THEREFORE
WE HAVE USED THAT FRAMEWORK FOR
RECOMMENDATIONS. I HOPE YOU
UNDERSTAND FROM ALL THE THINGS
WE HAVE SHOWN YOU SO FAR IN THE
LAST TEN SLIDES THAT AIM-AHEAD
HAS BEEN SIGNIFICANT,
TRANSFORMATIVE AND VERY LARGE
ECOSYSTEM. IN THAT CONNECTIVITY,
THE AREAS WE THINK COULD BE
STRENGTHENED BY THE FOLLOWING
RECOMMENDATIONS. SO ONE OF THE
CHALLENGES THAT CAME UP EVERY
SINGLE TIME WAS THE SHORT TIME
LINE .
THE ONE YEAR WAS TOO SHORT AND
IMPACTED WHAT I CALLED MORE LIKE
A PRI, THE PREPARATION, THE
REGULATORY COMPLIANCES. YOU HAVE
TO KNOW IN SOME OF THESE
ORGANIZATIONS THERE'S NOT A LOT
OF ROBUSTNESS IN TERMS OF I HAVE
RB AND (?) SO A LOT OF LEARNING
HAD TO HAPPEN IN ORDER TO
IMPLEMENT. THAT CHALLENGE WAS
ONE THAT WAS SIGNIFICANT IN
TERMS OF MAKING THIS AS
SIGNIFICANT AS WE'D LIKE BECAUSE
TIMING WAS NOT EXACTLY ON POINT.
WE WOULD REALLY LIKE
RECOMMENDATION ONE TO BE TO
EXTEND THE TIME LINE OF THE OTA
TO AT LEAST THREE YEARS, WHICH
REASSURANCES IN A TIMELY MANNER
SO PEOPLE COULD HAVE TIME FOR
THE PREPARATION AND GET IN ALL
THE DOCUMENTS IN LINE. CHALLENGE
TWO IS SIMILAR BECAUSE IT IS
ABOUT TIMING. BUT SHORTER
PERIODS MADE IT DIFFICULT FOR
COLLABORATIONS TO HAPPEN IN
TERMS OF MEANINGFUL
RELATIONSHIPS. AS WE KNOW, ONE
OF THE CURRENCIES OF
COLLABORATION, ESPECIALLY WITH
COMMUNITIES, IS TIME. TRUST
BUILDS WITH TIME. THIS LED TO
PEOPLE USING ALL COLLABORATION,
ALREADY READY, AND WE WOULD LOVE
TO SEE THIS EXTEND TO OTHER
COLLABORATIONS THAT ARE NOT AS
TIMELY AND THEREFORE COULD
ACTUALLY BE EXPANSIVE IN THAT
AMOUNT OF TIME. SO WE ARE
THINKING ABOUT A SIX-MONTH
REAWARD STAGE WHERE ALL THIS
COULD HAPPEN AND ESTABLISHMENT
OF COMMUNITY AMBASSADORS TO MAKE
SURE STRENGTH AND TRUST OF THOSE
INTERACTIONS NOT JUST HAPPEN BUT
BECOME ROBUST. THE THIRD
CHALLENGE WE HEARD A LOT OF WAS
MENTOR SHIP ALTHOUGH STRONG
LACKED CONSISTENCY. SOME MENTOR
MENTEE PEERS WERE NOT SIMILAR TO
OTHER S SO WE THINK WE COULD
ENHANCE THE SUCCESS OF THIS
RELATIONSHIP BY BUILDING IN MORE
RELIANCE ON WHAT THIS
RELATIONSHIP WOULD BE LIKE. I
THINK THERE ARE LOTS OF NEW
PROGRAMS REALLY LOOKING AT THESE
INDEPTH AND I THINK WE COULD
BRING SCIENCE OF MENTOR
MENTEEING INTO THIS. OUR FINAL
SLIDE IS RARELY TO ENHANCE AND
IMPLEMENT NOVEL EVALUATION
REPORT. WE TALKED ABOUT THAT IN
THE OTHER REPORT. WHERE WE
REALLY WANTED TO MAKE SURE THE
SCIENTIFIC COMMUNITY AND
AIM-AHEAD ECOSYSTEM UNITED
STATES HOW TRANSFORMATIVE WE
THINK THIS HAS BEEN IN SO MANY
WAYS BY CAPTURING MOVE OF THIS
INFORMATION. SO THEY HAVE
ESTABLISHED A PROCESS BUT THERE
ARE OPPORTUNITIES TO CAPTURE AND
IMPACT OUTCOMES SO WE WANTED TO
IMPACT OUTCOMES TO BE VALIDATED
IN WAYS THAT MADE SENSE,
MEASURED BASELINE DATA,
PROGRESS, QUANTIFY THE ROIs.
THERE ARE SO MANY WAYS WE THINK
WE COULD BE MORE EXPANSIVE. IT
WAS HAPPENING BUT NOT TRACK ED
IN A WAY WE THINK COULD REALLY
CHANGE THE SCIENTIFIC COMMUNITY
THE WAYS WE UNDERSTAND THE ROI
ON THIS INVESTMENT. LAST BUT NOT
LEAST, WE TALKED A LOT ABOUT
SUSTAINABILITY AS YOU HEARD FROM
MY PARTNERS AND COLLEAGUES
PRESENTED BEFORE ME. AIM-AHEAD
NURTURED SUSTAINABILITY THROUGH
LOTS OF CAPACITY BUILDING,
CONCIERGE SERVICES, LONG-TERM
SUSTAINABILITY IS KEY. WITHOUT
THAT WE WILL REALLY NOT BE AS
RELIANT ON GROUPS WE HAVE
ALREADY FORMED. THEY ARE SO
STRONG. WE REALLY WANT TO MAKE
SURE THIS CONTINUES WHETHER OR
NOT THERE IS FEDERAL FUNDING.
HOW DO WE DO THAT? HOW DO WE
INCENTIVISE A SUSTAINABLE
NETWORK THAT WE HAVE BUILT IN
ORDER TO GET THE DATA WE NEED,
IN ORDER TO GET THE RESULTS WE
NEED. SO IN BUILDING TOOLS,
TECHNOLOGY AND TALENT, WHILE WE
BUILD WE NEED TO INTEGRATE THEM
BETTER, MAKE CONNECTIVITY WORK
SO WE COULD SUSTAIN THESE REALLY
GREAT INTERACTIONS AND ALL
SUSTAINABLE AND TRANSFORMATIVE
THINGS THAT HAVE HAPPENED SO WE
ARE LOOKING FORWARD TO FIGURING
HOW TO ADOPT TRADE-IN AND
TRADE-OUT MODELS, SUPPORT
UNDERRESOURCED COMMUNITIES. I
THINK ABOUT THIS WHEN I LISTEN
TO ALL THE INFORMATION WE GOT AS
AI FOR ALL. AS YOU COULD TELL
FROM THE MAP, WE REALLY DID
INFILTRATE ALMOST EVERY SINGLE
STATE IN THE UNITED STATES. WE
REALLY NEED TO DO A BETTER JOB
OF MAKING SURE NOT ONLY HAVE WE
DONE WHAT WE HAVE DONE RIGHT NOW
BUT CONTINUE THIS MODEL AND
HOPEFULLY DO IT AGAIN AND MAKE
SURE IT IS SUSTAINABLE. NEXT
SLIDE, PLEASE. I THINK THAT IS
THE LAST SLIDE. ALL RIGHT. OPEN
FOR DISCUSSION, THANK YOU VERY
MUCH.
>> THANK YOU SO MUCH, SUSAN,
KAREN AND JEAN. AS WITH THE
PREVIOUS WORK GROUP REPORT WE
WILL TAKE A VOTE ON WHETHER
COUNCIL ACCEPTS REPORT BUT FIRST
WE WANT TO OPEN IT TO QUESTIONS.
IF THERE ARE QUESTIONS, PLEASE
RAISE YOUR HAND. YOU WILL BE
RECOGNIZED BY FRANZISKA AND
ASKED TO UNMUTE YOURSELF.
>> THANK YOU, NICOLE. I SEE
LAUREN, YOU HAVE YOUR HANDS UP.
GOES TO YOU.
>> THANK YOU. APPRECIATE THE
EFFORT TOWARDS REGULATORY
COMPLIANCE AND PROCESS YOU HAVE
FOR CENTRALIZING THAT. THAT
SOUNDS GREAT. I'M JUST WONDERING
HOW YOU THINK ABOUT KEEPING UP
TO DATE WITH, YOU KNOW, POLICY,
REGULATORY SORT OF ASSURANCE
LAB. THERE'S A LOT OF DISCUSSION
HERE ABOUT BEST PRACTICES IN
HEALTH CARE, THE NATIONAL
ACADEMIES ISSUED A REPORT. SO
THAT SORT OF SOFT OR NOT PURE
COMPLIANCE BUT EXPECTATION OF
BEST PRACTICES AND EVOLVING
PATROL S POLICY /* /* -- POLICY
AND HOW YOU ARE INCORPORATING
THAT SO PEOPLE ARE THINKING
ABOUT IN IT THAT SPACE.
>> I'M HAPPY TO START ON THAT
AND MAYBE MY COLLEAGUES CAN
COMMENT FURTHER. ONE OF THE
RECOMMENDATIONS WE MADE IS THEY
CAN CONTINUE TO CENTRALIZE SOME
OF THESE RESOURCES SO THAT THE
REGULATORY TEAM COULD
POTENTIALLY BE CHARGED WITH
REALLY WORKING HARD TO MAKE SURE
THEY ARE UP TO DATE AND GETTING
THOSE UP-TO-DATE REGULATIONS
IMMEDIATELY OUT TO THE HEAD
AWARDEES, ESPECIALLY FOLKS GOING
THROUGH THE REGULATORY PROCESS
AT THAT TIME. SO WE TOTALLY
AGREE WITH YOU THAT THAT IS A
BIG LIFT TO KEEP UP WITH THE
REGULATORY REQUIREMENTS, SO OUR
HOPE IS BY CENTRALIZING IT AND
CONTINUING TO OFFER THIS
CONCIERGE-LIKE SERVICE THAT WE
WOULD BE ABLE TO SUPPORT THE
AIM-AHEAD TEAM MEMBERS THAT WAY.
>> I JUST WANT TO ADD TO THAT,
EXACTLY RIGHT. I THINK THAT SO
MUCH IS CHANGING SO QUICKLY, IT
IS REALLY DIFFICULT FOR YOU TO
GET WIT ON THE GROUND,
ESPECIALLY FOR THESE COMMUNITY
ORGANIZATIONS AND ORGANIZATIONS
THAT NOT AS TIGHTLY LINKED TO
THE WHOLE ECOSYSTEM. SO HAVING
SOME PLACE WHERE THE EXPERTISE
RESIDE AND THEN USING THAT AS
CORE TO FIND OUT TO ALL OF THE
COMMUNITY MEMBERS MAYBE THE BEST
WAY TO DO THAT. WE HAVE A CORE
WHOSE JOB IS TO FIGURE IT OUT
AND THEIR JOB IS TO GET IT OUT
TO OTHERS, SO THAT THE PEOPLE
WHO UNDERSTAND IT THE BEST
ACTUALLY SPENDING TIME
UNDERSTANDING ALL OF THE NEW
GUIDELINES THAT WILL BE COMING
DOWN AND NEW LEARN ING THAT IS
HAPPENING AS WE DO MORE AND MORE
OF THIS KIND OF RESEARCH.
>> GREAT, THANK YOU FOR
QUESTION. I ASSUME THAT ADDRESS
YOUR COMMENTS, RIGHT?
>> YES.
>> DR. LLOYD, YOU HAVE THE NEXT
QUESTION.
>> YEAH, SO DR. JOHNSON, DR.
KING, I ASK THIS QUESTION BUT IN
THE CONTEXT OF BEING A CHAIR OF
THER WORKING GROUPS -- OTHER
WORKING GROUPS, I KNOW HOW
DIFFICULT SO PLEASE TAKE THIS IN
A POSITIVE WAY. I READ YOUR
REPORT AND LISTENED CAREFULLY. I
JUST GO BACK TO THE FIRST
SENTENCE OF THE EXECUTIVE
SUMMARY. SAYS LAUNCH ED IN 2021,
AIM-AHEAD. TO IMPROVE HEALTH OF
ALL AMERICANS. BUT I DIDN'T HEAR
ANYTHING ABOUT THAT. WHAT I
HEARD IN THE FIRST PRESENTATION,
DR. JOHNSON YOU TALKED ABOUT
THOSE BUT YOU ARE GREAT. MEMBER,
INSTITUTIONS, EXTREMELY
IMPRESSIVE BUT METRICS AREN'T
IMPACTS. DR. KING I WAS
LISTENING TO YOUR
RECOMMENDATIONS BUT THOSE SEEM
MOSTLY ABOUT PROCESS, NOT ABOUT
HOW ARE WE EVALUATING THE --
AGAIN, THE ROI ON QUOTE,
UNQUOTE, IMPROVING HEALTH OF ALL
AMERICANS. INTERPRET THAT AS YOU
WILL. MY QUESTION IS DID THE
WORKING GROUP GET INPUT FROM ALL
THE PERSONS YOU SPOKE TO ABOUT
WHAT HAS THE IMPACT OF THIS
PROGRAM BEEN ON, YOU KNOW,
REDUCING HEALTH DISPARITIES,
REDUCING CANCER INCIDENTS,
IMPROVING ACCESS TO HEALTH CARE.
WHATEVER THE REAL HUMAN HEALTH
IMPACTS ARE. DID YOU TALK TO AND
INTERVIEW PEOPLE TO GET FEEDBACK
ON THAT? DO YOU THINK THERE
SHOULD BE RECOMMENDATIONS ABOUT
HOW TO IMPROVE THAT TYPE OF
REPORTING, THANKS.
>> YEAH, I'M HAPPY TO START THIS
ONE TOO. THEN MY COLLEAGUES CAN
JUMP IN. SO I THINK YOU ARE
SPOT-ON WITH THAT QUESTION. THAT
IS ONE OF THE THINGS THAT WE
TALKED A LOT ABOUT. AS YOU KNOW,
EARLY IN A PROGRAM OFTEN WE WILL
MEASURE THE PROCESS PIECES AND
THE TOUCHES. THEN LATER IN A
PROGRAM WE TEND TO MEASURE THE
ACTUAL IMPACT. SO IT IS A LITTLE
EARLY TO REALLY CAPTURE IMPACT.
AND TO ADDRESS YOUR QUESTION
ABOUT WHETHER WE TALK TO FOLKS
ABOUT THAT, WE DID. BUT WE HEARD
MORE ANECDOTAL STORIES ABOUT THE
IMPACT ON THEM AS INDIVIDUALS.
EITHER COMMUNITY STAKEHOLDERS OR
AWARDEES OR TRAINEES. THEY WOULD
TALK ABOUT HOW IMPACTFUL THE
PROGRAM WAS FOR THEIR INDIVIDUAL
ENGAGEMENT IN THIS TYPE OF WORK.
LESS SO ABOUT THE IMPACT ON
LARGER POPULATIONS. SO AS YOU
HEARD FROM DR. KING, ONE OF OUR
RECOMMENDATIONS WAS FOR THE
AIM-AHEAD TEAM TO START TO GET
MORE
MORE -- CREATIVE AND KNOW
INVESTIGATIVE METRICS TO CAPTURE
THE TRUE IMPACT ON PEOPLE AND
POPULATION HEALTH THAT. IS MY
PERSPECTIVE. DR. KING, I DON'T
KNOW IF YOU WANT TO COMMENT ON
THAT.
>> THAT IS A GREAT QUESTION.
THANK YOU FOR ASKING. TO REALLY
TALK ABOUT WHAT DR. JOHNSON JUST
SAID, THAT IS EXACTLY WHAT
HAPPENED. WE STARTED WHERE
PEOPLE SAID THESE ARE CHALLENGE,
THESE RECOMMENDATION ALSO MAKE
IT BETTER. WHAT WE DIDN'T FIND
AS MUCH, WHICH IS WHY SUCCESS
METRIC S IS WHAT I FOCUSED ON
NUMBER FOUR, IS WE NEED TO TELL
YOU WHAT ARE SUCCESS METRICS WE
CAN ACTUALLY TALK ABOUT MORE. TO
SUZANNE'S POINT, THEY REALLY DID
TALK AND KAREN, THEY TALKED
ABOUT THE INDIVIDUAL BASIS. NOW
WHAT WE DID FIND OUT IS THERE
ARE LOTS OF GRANTS THEY HAVE
SUBMITTED THAT WAS, YOU KNOW,
SORT OF BECAUSE OF THIS, THEY
WERE ABLE TO LEVERAGE THIS
OPPORTUNITY TO WRITE MORE
GRANTS. THE GRANTS THEY WERE
WRITING WERE REALLY MUCH MORE
INCLUSIVE SO A LOT OF THE IMPACT
WILL COME. WHAT I THINK HAS BEEN
THE BIGGEST IMPACT, FROM MY
PERSPECTIVE, IS THOW DO WE
SUSTAIN THIS BECAUSE THE IMPACT
IS YET TO COME. IT WAS VERY
QUICK. EVERYTHING GOT TOGETHER.
THEY FINALLY JUST GOT THE STUDY
DONE. LOTS OF PAPERIN S AGO. LO
OF PRESENTATIONS. WE ARE JUST
THERE SO THIS FORWARD THINK ING
IS WHAT WE BROUGHT. YOU NEED TO
TELL US MORE BUT SUCCESS
MEASURES IN TERMS OF WIDER
ECOSYSTEM AND TELL US HOW YOU
ARE GOING TO SUSTAIN THIS SINCE
YOU HAVE DONE THE WORK. FELT
LIKE THEY HAD THE TOOLS. OF
COURSE TOOL, TECHNOLOGY AND
TALENT. ALL THOSE THREE CAME
TOGETHER. NOW TO USE THOSE TO
IMPLEMENT THE KIND OF IMPACT YOU
ARE LOOKING FOR, I THINK IT IS
ALREADY THERE, WE HAVE TO HAVE
BETTER SUCCESS MEASURES OTHER
THAN HOW MANY PRESENTATIONS, HOW
GOOD WAS THE MENTOR AND MENTEE
RELATIONSHIP.
>> RIGHT, THANK YOU. DR. KING,
WE MISSED THE LAST PART OF WHAT
YOU WERE SAYING BECAUSE --
>> SORRY ABOUT THAT. SOMEHOW MY
HAND HIT THAT. WHAT I THINK WE
ARE RIGHT NOW, QUICKLY REPEAT
IT, WE HAVE TALENT, TECHNOLOGY
AND TOOLS. ALL THOSE THINGS CAME
TOGETHER. SO IT IS NOW TO USE
ALL THOSE TO THE IMPACT THAT WE
WOULD LOVE TO SEE IS HAPPENING
BUT JUST NOW. WE ARE THERE RIGHT
NOW AND WHAT WE TALK ABOUT A LOT
IS HAVING SUCCESS MEASURES WE
COULD TALK ABOUT ALL THE THINGS
WE JUST TALKED ABOUT. WHAT
CHANGE ED?ENTER WE SAW A LOT
CHANGE BECAUSE LOTS OF PAPERS
AND GRANTS WENT IN. ALL THAT
HAPPENED BUT WASN'T AS COHESIVE
SUCCESS MEASURES AS WE'D LIKE TO
PRESENT. THE INDIAN SITE FOR
EXAMPLE, THEY TALKED ABOUT HOW
THAT CHANGED ALL THE
INTERACTIONS. THE COMMITMENT TO
NEW COMMUNITY MEMBERS COMING IN
TO AI. SO IT FELT LIKE AI FOR
ALL. NOW WE HAVE TO USE IT TO DO
THE IMPACT PIECE. WHICH HAPPENED
BUT IT WASN'T AS CLEAR AS WE
WOULD HAVE LIKED IT TO BE,
HENCE WHY MUCH OF OUR
RECOMMENDATIONS HOW TO MAKE IT
STRONGER AND HOW TO HAVE BETTER
SUCCESS MEASURES GOING FORWARD.
SUSAN, ANYTHING ELSE YOU WANT TO
ADD?
>> I COMPLETELY CONCUR. WHAT YOU
SAID RESONATES WITH ME QUITE A
BIT. NOW LOOKING FOR THE LARGER
IMPACT, IF WE GO FORWARD, WOULD
BE REALLY KEEN OUTCOME FOR THE
NEXT PHASE.
>> GREAT. SO THANK YOU ALL FOR
ANSWERING THE QUESTIONS. I SEE
NO OTHER QUESTIONS. I SAW
MONICA'S CAMERA CAME ON BUT I
ASSUME THAT CAMERA CAME ON NOT
WANTING TO ASK A QUESTION. IF
THAT IS CORRECT, THEN CAN MOVE
ON TO THE VOTE. BECAUSE YOU JUST
VOTED, YOU ARE ALL EXPERTS IN
VOTING. DO NOT NEED TO REPEAT
THE INSTRUCTIONS. I WILL ASK FOR
A MOTION AND WAIT FOR THE SO
MOVED AND SECOND. MAY I HAVE A
MOTION TO ACCEPT AS WRITTEN THE
REPORT OF THE AIM-AHEAD WORKING
GROUP OF THE COUNCIL OF
COUNCILS. I SEE. SO MOVED. DO I
GET A SECOND? I SEE THE SECOND.
THAT WILL ALLOW ME TO ASK IS
THERE ANY ADDITIONAL DISCUSSION
AT THIS POINT?
>> FRANZISKA -- GOOD, NEVERMIND.
>> I KIND OF SAW THE SECOND OF
THE SO MOVED, I GET IT. ANY
DISCUSSION AT THIS POINT, IN
ADDITION TO WHAT WE ALREADY
HEARD? I DON'T SEE RAISED HANDS.
>> THANK YOU, DOCTOR. THIS IS A
VOTE ON MOTION TO ACCEPT AS
WRITTEN THE WORKING GROUP OF
COUNCIL OF COUNCILS. AS REMINDER
ONLINE COUNCILMEMBERS SHOULD
PARTICIPATE. PLEASE RAISE YOUR
HANDS TO VOTE AYE. THANK YOU, I
SEE THE HANDS RAISING. I SEE
EIGHT HANDS. ALL RIGHT. PLEASE
LOWER YOUR HANDS -- WAIT, I SEE
ANOTHER HAND.
I'M SEEING HANDS COMING UP.
THIS IS A VOTE FOR AYE. IF YOUR
HANDS ARE RAISED. OKAY. I'M
SEEING HANDS COME BACK UP. WANT
TO LEAVE IT UP A LITTLE LONGER
FOR FOLKS TO VOTE AYE. OKAY. WE
ARE GOING TO MOVE ALONG SO
PLEASE LOWER YOUR HANDS. THANK
YOU. PLEASE RAISE YOUR HAND IF
YOU ARE VOTING NAY. IF YOU WOULD
LIKE TO VOTE NAY, PLEASE RAISE
YOUR HAND AT THIS TIME. NOT
SEEING ANY HANDS. PLEASE RAISE
YOUR HAND TO VOTE ABSTENTION.
NOT SEEING ANY HANDS. THIS
CONCLUDES THE VOTE. THE MOTION,
AS STATED, AS PASSED.
>> THANK YOU, CHRISTINA. I
CLEARLY SEE THAT THE MEMBERS WHO
ARE ON THE WORKING GROUPS ARE
NOT VOTING, SO THAT IS WHY WE
HAD EIGHT VOTES ON THE SECOND
AND NINE AT THE FIRST ONE.
MEMBERS WHO CONTRIBUTED TO
WORKING GROUP DID NOT
PARTICIPATE. SO THANK YOU ALL.
ONE QUICK COMMENT. WE WERE
LOOKING INTO LIKE NOT DOING THE
HAND-RAISING AND HAVING
DIFFERENT METHODS. MAYBE UNTIL
THE NEXT TIME WE HAVE SOMETHING
MORE SUCCESSFUL IF WE ARE
IN-PERSON. THEN ANYHOW IT WILL
BE EASIER. BACK TO YOU, NICOLE.
>> THANK YOU. SO ONCE AGAIN, AS
SIMILAR TO HOW WE HANDLE THIS
FOR THE GRI REPORT, IF THERE ARE
ADDITIONAL VIEWS THAT THE
COUNCIL WOULD LIKE TO CONVEY
WITH THE REPORT, PLEASE TYPE
THOSE IN THE CHAT. SO BEFORE WE
BREAK FOR LUNCH, I WOULD JUST
LIKE TO CONGRATULATE EVERYONE
FOR BEING SO PERFECTLY ON TIME,
BUT BEFORE WE BREAK FOR LUNCH I
DID WANT TO FOLLOW UP ON SEVERAL
OF THE QUESTIONS THAT WERE
RAISED IN ONE OF THE EARLIER
SESSIONS. I HAVE PUT IN THE CHAT
RESPONSES FROM OUR OSC
COLLEAGUES IN RESPONSE TO DR.
MANLEY'S QUESTIONS, RECOGNIZING
THOSE VIEWING THE WEBCAST DO NOT
HAVE ACCESS TO THE CHAT, I WILL
READ THE RESPONSES FOR THE
BENEFIT OF THOSE VIEWERS THEN WE
WILL BREAK FOR LUNCH. SO THE
FIRST QUESTION, WHEN DO YOU
EXPECT DP5 MECHANISM TO BE
POSTED. IF IT WILL NOT BE, WHY.
THE RESPONSE, THE INITIAL DRAFT
OF FY2026DP5NOFO WAS PAUSED BY
NIH LEADERSHIP BUT MOVE FORWARD
AFTER COMPARISON BETWEEN DP5s
AND EARLY EARLY STAGE
INITIATIVES ACROSS NIH. THERE
WAS A FULL EVALUATION REPORT ED
IN REPORT FOR DP2s, NEW
INNOVATOR AWARDS GIVEN WILD
SUCCESS IN THE PAST. NEW
RESPONSE, THIS REDUCTION WAS
DRIVEN BY BUDGET RESTRICTIONS
AND CHANGE IN MYF POLICIES
ACROSS HHS. AS ANY FISCAL YEAR
UNFOLDS AND BUDGET AND SPENDING
BECOMES CLEARER THE NUMBER OF
AWARDS WE ARE ABLE TO FUND MAY
BE SLIGHTLY HIGHER OR LOWER THAN
ANTICIPATED. THIS FLUCTUATION
DOES NOT REFLECT PROGRAMMATIC
INTENTION. WE ARE TRYING TO FUND
AT LEAST 30 NEW INNOVATORS EACH
YEAR. THIRD QUESTION, HOW WILL
DPCPSI STAFF REDUCE NEGATIVE
IMPACT OF CONSTRICTED WINDOW
BETWEEN POSTING AND DUE DATE
ESPECIALLY FOR THE 2. STAFF WILL
PRO OR ADVERTISE POTENTIAL
APPLICANTS IN RESPONDING DURING
POSTING DATES. DETAILED
APPLICATION GUIDES ARE AVAILABLE
ON THE WEBSITE. TECHNICAL
ASSISTANCE WEBINAR ALSO BE
POSTED AS SOON AS NOFOs ARE
PUBLISHED. MAJOR CHANGES ARE NOT
ANTICIPATED FOR DPs 1, 2 AND 5.
FOURTH QUESTION, YOU CLARIFY
COUNCIL'S ROLE IN ASSESSING
UNIFORMITY AND REVIEW OF THE
PROGRAM NOW THAT STOP WORK
ORDER S HAVE BEEN ISSUED TO SIX
HRHR GRANTS PREVIOUSLY APPROVED
BY COC. RESPONSE, COUNCIL'S ROLE
IS ASSESS FAIRNESS REVIEW BUT
FUNDING DECISIONS ARE LEFT TO
THE ICO. PROGRAM STAFF ARE
FOLLOWING POLICIES APPROVED BY
HHS, AND NIH AND CONSULTING WITH
ADMINISTERING ACs IN
CATEGORIZING AWARDS, SO THANKS
TO COLLEAGUES FOR PROVIDING
THOROUGH RESPONSES TO THESE
QUESTIONS. NOW WE WILL GO AHEAD
AND HAVE A SHORT BREAK. EXCUSE
ME. BEFORE WE TRANSITION TO THE
CLOSED SESSION OF TODAY'S
MEETING SO I WOULD ASK ALL OUR
MEMBERS PLEASE REMAIN LOGGED IN
AND MUTED. WE WILL SEE EVERYONE
BACK IN THIRTY MINUTES, BY
12:15. THIS IS ONLINE
COUNCILMEMBERS AND STAFF WITH
NEED TO KNOW WILL BE
PARTICIPATING IN THE CLOSED
SESSION .
THE OPEN WILL RESUME AT
1:15 P.M. THANK YOU ALL.
ALL RIGHT, SO NEXT ON OUR AGENDA
IS A PRESENTATION OF THE OFFICE
OF NUTRITION RESEARCH STRATEGIC
PLAN AND UPDATE ON THE UPDATE OF
DIETARY SUPPLEMENTS STRATEGIC
PLAN.
DR. BREMER DIRECTOR WILL
PRESENT.
>> THANK YOU, NICOLE AND THANK
YOU EVERYONE FOR TODAY AND THE
COUNCIL MEMBERS AND JUST WHAT
EVERYONE WANTS TO TALK ABOUT
AVENUE TRIGS -- AFTER LUNCH IS
NUTRITION AND DIET.
I CAN'T WAIT.
AM I COMING IN TOO LOUD OR IS
ALL GOOD ON THAT END.
>> YOU SOUND, GREAT, DREW.
>> FANTASTIC.
I'LL START BY SAYING I HAVE THE
PRIVILEGE AND HONOR TO BE
WORKING IN TWO OFFICES.
THE OFFICE OF NUTRITION RESEARCH
AND DIETARY SUPPLEMENTS.
I HAVE BOTH TEAMS IN THE OFFICE
WITH ME AND IT'S TRULY A
PRIVILEGE.
AND THANK YOU TO THE COUNCIL
MEMBERS FOR TAKING TIME TO
LISTEN TO ME AND GIVING ME A
CHANCE TO GIVE A HIGH-LEVEL
OVERVIEW OF THE PLANS FOR BOTH
OFFICES.
AND I'LL START BY SAYING THAT
THE O & R PLAN OF TUESDAY IS
OFFICIALLY APPROVED AND GETTING
READY TO BE LAUNCHED TO PUBLIC.
I'D LIKE TO THANK THE CONSULTING
GROUP FOR MAKING IT LOOK SO
PRETTY AND I THINK YOU HAVE
COPIES IN THE ROOM AND WE'VE HAD
A CHANCE TO PRESENT ON THE
OFFICE OF DIETARY SUPPLEMENT
PLAN LAST YEAR AND GIVE YOU AN
UPDATE HOW THINGS HAVE GONE IN
THE PAST 12 MONTHS.
I'D LIKE TO START MY TALKS WITH
THE GRATITUDE AND ACKNOWLEDGING
THOSE WHO DO THE WORK.
I HAVE THE EXTRAORDINARY
PRIVILEGE OF WORKING WITH
AMAZING INDIVIDUALS.
AND I'LL TRY TO GET BACK TIME AT
THE END BECAUSE I KNOW THERE'S
SOME QUESTIONS WE WANT TO HAVE A
CHANCE TO ADDRESS BEFORE COUNCIL
CLOSES SO I'LL BE STREAMLINED
BUT I DON'T WANT TO MISS
ANYTHING IMPORTANT AND
ACKNOWLEDGING THE INDIVIDUALS
WHO DO THE WORK IS SUPER
IMPORTANT.
FOR THE O&R AND ODR TEAM MEMBERS
AND PAST I WANT TO SAY THANKS
AND TO THOSE ON THE ZOOM AND
TEAMS WE WORKED WITH AND FEDERAL
COLLEAGUES AND CERTAINLY OUR
EXTRA MURAL COLLEAGUES AND TEAM
WORK MAKES THE DREAM WORK AS I
SAY.
AS YOU'VE HEARD ABOUT TODAY IS
THE OFFICES IN DPCPSI SERVE A
ROLE TO COORDINATE, PROVIDE
SUPPORT AND SERVICE TO THE NIH
AS A WHOLE.
THAT'S ONE OF THE STRATEGIC
LOCATIONS OF BEING IN THE OFFICE
OF THE DIRECTOR IS THAT WE HAVE
THAT ACCESSIBILITY TO OTHER
INSTITUTES AND CENTERS.
BUT OUR REACH GOES WELL BEYOND
THAT, WE ALSO WORK CLOSELY WITH
A LOT OF OUR FEDERAL PARTNERS
AND THAT MAKES THE OFFICES NOT
JUST AN NIH OFFICE BUT REALLY A
U.S. GOVERNMENT OFFICE AND
RANGES FROM THE USDA, NHANES,
NIST WE HAVE FINGERS IN LOTS OF
POTS AND BRING OUR EXPERTISE AND
SKILL SET TO ADVANCE THE
MISSIONS OF THE OTHER AGENCIES.
BEYOND THAT WE ALSO REACH BEYOND
THE U.S. GOVERNMENT.
I LISTED TWO HERE AS
ILLUSTRATIVE EXAMPLES OF THE
GATES FOUNDATION AND NATIONAL
COLLABORATIVE OF CHILDHOOD
RESEARCHES AND BOTH OFFICES ARE
IN COLLABORATION AND IT'S MEANT
TO BE AN EXPANSIVE LIFT TO MOVE
THE FIELD FORWARD.
SO WHAT'S OUR VALUE ADD?
WHEN I JOINED DPCPSI SEPTEMBER
2023 I CHALLENGED OUR TEAMS TO
THINK ABOUT WHY WE'RE HERE AND
WHAT WOULD GO AWAY IF WE WEREN'T
HERE AND WE REALLY NARROWED IT
DOWN TO THREE PARTS OF A TRY
ANGLE AND WE BRING OUR SUBJECT
MATTER EXPERTISE AND WE'RE
SCIENTIFIC LEADERS AND WE COME
FROM VARIOUS BACKGROUNDS AND ALL
THAT REALLY EMBODIES THE WHOLE
IS MORE THAN THE SUM OF ITS
PARTS.
WE PROVIDE SERVICE, TECHNICAL
SUPPORT AND COORDINATE.
THAT'S WHAT DIFFERENTIATES OUR
OFFICES FROM MAYBE TOPIC SIMILAR
OFFICES IN THE INSTITUTES AND
CENTERS.
AGAIN, I HAD THE PRIVILEGE OF
JOINING THE OFFICE OF RESEARCH
IN SEPTEMBER '23.
IT'S BEEN A WONDERFUL
OPPORTUNITY AND TREMENDOUS JOY.
I LOVE COMING TO WORK EVERY DAY.
IF YOU THINK I'M EXCITED NOW
WAIT UNTIL I GET TO THE OTHER
SUBJECTS.
I WANT TO HONE IN ON OUR GUIDING
PRINCIPLES.
WHEN YOU TALK OR HEAR ABOUT
NUTRITION IT MEANS DIFFERENT
THINGS TO DIFFERENT PEOPLE.
IF YOU ASK 20 NUTRITIONISTS WHAT
IS NUTRITION YOU'LL GET TO
ANSWERS AND NUTRITION IS CULTURE
AND FAMILY AND MEMORY BUT
NUTRITION IS MORE THAN FOOD.
FOOD IS THE DELIVERING MECHANISM
BUT THE NUTRITION IS ALL THE
COOL BIOLOGY THAT HAPPENS WHEN
YOU INGEST SOMETHING.
IT GOES TO THE SECOND POINT.
IT'S AN EXPANSIVE BIOLOGY THAT
GOES FROM THE FOOD INGESTED TO
METABOLISM TO IMPACT ON CELLULAR
FUNCTION.
FOOD IS THE LINK AND NUTRITION
SCIENCE IS THE LINK BETWEEN THE
FOOD WE EAT AND OUR OVER ALL
HEALTH PHYSICAL AND MENTAL.
THOSE WHO HEARD ME BEFORE, HEARD
ME SAY THE BIOLOGY OF NUTRITION
TOUCHES EVERY TELL OF EVERY
SYSTEM IN OUR BODIES IN EVERY
STAGE AND AGE ACROSS THE LIFE
SPAN AND LINKED TO HEALTH AND
DISEASE.
I HAD THE PRIVILEGE OF BEING AN
INTERNAL MEDICINE PEDIATRICS
PHYSICIAN AND IN TEACHING
MEDICAL STUDENTS AND RESIDENTS I
CHALLENGED THEM TO THINK ABOUT
SOMETHING THAT ISN'T IMPACTED BY
NUTRITION OR IMPACTED BY
NUTRITION.
NUTRITIONAL STATUS IS A
FUNDAMENTAL BIOLOGICAL VARIABLE
LIKE AGE AND SEX.
IT'S GOT AN INEXTRICABLE ROLE IN
HEALTH AND DISEASE AND MEDICAL
THERAPIES AND EXPOSURES CAN
OFTEN IMPACT THE NUTRITIONAL
STATUS OF THE PERSON THEREAFTER.
SO IT'S UNLIKE AGE AND SEX WHERE
AGE GOES CRHRONOLOGICALLY AND SX
IS DETERMINED BY CHROMOSOMES.
NUTRITIONAL STATUS IS VERY
FLUID.
AND THE LAST POINT IT'S DISEASE
AGNOSTIC WHICH IT TOUCHES AND
I'LL TOUCH OB IN A SECOND AT 24
INSTITUTES AND CENTERS AS WELL
AS THE OFFICE OF THE DIRECTOR
AND NUTRITION SCIENCES.
SO WHY DO I LOVE TALKING ABOUT
THIS AND WHY DO I CARE SO MUCH
AND LOVE COMING TO WORK EVERY
DAY?
THIS IS NOT NEWS TO YOU BUT IT
IS LEVEL SETTING I THINK.
WE'RE ESPECIALLY IN THE NEWS
THESE DAYS WITH MAHA WE'RE
FACING AN URGENT NUTRITION
RELATED HEALTH CRISIS.
AT A GLOBAL LEVEL BOWEL
NUTRITION IS THE LEADING CAUSE
OF MORBIDITY AND MORTALITY AND
IN THE U.S. SUB NUTRITION IS
THREATENING OUR PUBLIC HEALTH,
WE HEAR ABOUT EVERY DAY AND
AFFECTS OUR ECONOMY AND NATIONAL
SECURITY.
NEARLY 8 OF 10 U.S. YOUNG ADULTS
CANNOT QUALIFY FOR THE MILITARY
DUE TO A DIET RELATED CONDITION
INCLUDING OBESITY, NEARLY 8 IN
10.
IT'S SUPER IMPORTANT.
AND CHRONIC RELATED DISEASES
IT'S ESTIMATED TO LEAD TO THE
DEATH OF 16,000 AMERICANS EACH
WEEK AND 1500 NEW CASES OF
CANCER PER WEEK IS THE EXTENT OF
THE PROBLEM.
I MENTIONED THE COST EXCEEDING
$1.1 TRILLION PER YEAR.
AGAIN, IT'S SUBOPTIMAL DIETS AND
KILL MORE THAN TOBACCO SMOKING
AND OTHERS AND IT'S THE LEADING
REASON AND MORE AMERICANS HAVE
DIED FROM DIABETES MORE THAN THE
ENTIRE CIVIL AND WORLD WAR.
THAT'S HUGE.
SO WHEN I CAME TO O&R WE THOUGHT
ABOUT WHERE SHOULD WE GO.
WE ASSESSED WHERE WE WERE AND WE
ENGAGED EACH OTHER AND ENGAGED
LOCAL PARTNERS AND EXTRAMURAL
PARTNERS AND DID A LOT OF
REFLECTION.
THOSE WHO KNOW ME KNOW I LIKE TO
THINK ABOUT THINGS AND REFINE
BASED ON ASSESSMENT AND FEEDBACK
AND I ALSO WANTED TO HAVE AN
OFFICE PLAN JUST LIKE THE OFFICE
OF DIETARY SUPPLEMENT THAT WAS
ACTIONABLE.
WE DIDN'T JUST WANT TO
PONTIFICATE.
WE WANTED TO TAKE THE THOUGHTS
AND MOVE THEM INTO ACTION.
JUST ON TUESDAY WE HAVE NOW A
CODIFIED PLAN FOR THE NEXT
SEVERAL FISCAL YEARS FOR THE
OFFICE.
SO O & R AND FOR THOSE ON THE
COUNCIL OF COUNCILS WHO HASN'T
HEARD ABOUT THE OFFICE YET.
WE ENFORCE THE ROLE OF NUTRITION
IN ALL ASPECTS OF HUMAN BIOLOGY,
I SAID BEFORE.
WE COORDINATE RESEARCH ACROSS
THE NIH AND BEYOND.
WE ADVISE HHS LEADERSHIP AND
ANYONE WHO WILL LISTEN, FOR THAT
MATTER, ON ANYTHING NUTRITION
AND NUTRITION RELATED.
WE LEAD COMMITTEES.
IT'S NOT JUST TO BE ON
COMMITTEES BUT STILL LEAD.
THERE'S A BIG DISTINCTION THERE
AND THE LAST SEVERAL YEARS HAS
BEEN EXTREMELY INSTRUMENTAL IN
HIS TEAM IN PRODUCING A N A BIAL
NUTRITION AND REPORT.
AND WE HAVE SIX.
24 OF THE INSTITUTES AND CENTERS
AS WELL AS THE OD HAVE A
NUTRITION PORTFOLIO.
HIGH LEVEL CONTEXT OF THE SPACE
APPROXIMATELY $2 BILLION PER
YEAR SPENT ON NUTRITION RELATED
SCIENCE PART OF THE NIH
OBLIGATIONS.
WE HAVE A BROAD REACH AND OUR
PURPOSE IS TO OPTIMIZE WHOLE
PERSON HEALTH AND REALIZING HOW
IMPORTANT THE ROLE OF NUTRITION
IS.
SO MISSION AND VISION.
THIS WAS SUPER IMPORTANT TO ME
TO CODIFY THESE AND I'M NOT
GOING TO READ THESE WORD BY WORD
BUT AT A SUPER HIGH LEVEL OUR
VISION IS TO THINK ABOUT
IMPACTING HEALTH NOW BUT ALSO
IMPACTING HEALTH IN THE FUTURE.
AND FROM A MISSION STANDPOINT TO
EMBRACE THE COMPLEXITIES OF
DOING NUTRITION SCIENCE.
THIS IS A FIELD THAT'S
EXTRAORDINARILY DIFFICULT TO DO
BECAUSE OF ALL THE VARIABLES
INVOLVED.
BUT THINKING ABOUT NUTRITION IN
AN ECOLOGICAL FRAMEWORK CAN WE
HOPE TO MOVE THE FIELD FORWARD.
PART OF THE GOALS IS TO IMPROVE
PRECISION AND IN THE ASSESSMENT
OF NUTRITIONAL STATUS AND INFORM
PRACTICES AND POLICIES.
I'LL TALK ABOUT GENERATING
EVIDENCE IN A LITTLE BIT.
AS FAR AS OUR STRATEGY GOES YOU
HEARD ME MENTION IT'S REALLY
SERVICE, TECHNICAL SUPPORT AND
ASSISTANCE AND COORDINATION AND
THEN AS FAR AS VALUES, ALL THOSE
ARE IMPORTANT BUT INTEGRITY AND
CURIOSITY AND TRANSPARENCY RISE.
THINKING OF HARD PROBLEMS WITH
NEW LENSES IN NEW WAYS TO
SUPPORT RESEARCH THAT'S SOLUTION
FOCUSSED AND ACTIONABLE.
SO HERE'S OUR STRATEGIC PLAN
FRAMEWORK.
IT HAS FOUR MAJOR GOALS AS WELL
AS TWO CROSS-CUTTING PRIORITIES.
ON THE NEXT TWO SLIDES I'LL GO
MORE INTO DETAILS WITH THESE
GOALS BUT THEY'RE REALLY TO
ADVANCE SCIENCE.
THAT'S WHY WE'RE HERE TO ADVANCE
SCIENCE.
TO GENERATE EVIDENCE.
WE'LL TALK ABOUT GENERATING
EVIDENCE TO HELP IN CLINICAL
PRACTICE AND GENERATING EVIDENCE
TO HELP IN THE REGULATORY SPACE
BUT GENERATING EVIDENCE TO
INFORM DECISION MAKERS AS THEY
MAKE THEIR DECISIONS BUILDING
CAPACITY.
TRAINING AND EXPANDING THE
CAPACITY OF THE CURRENT
NUTRITIONAL WORKFORCE TO DEAL
WITH A LOT OF THE SERIOUS ISSUES
THAT ARE RIGHT AT HAND AND THEN
FOSTERING STEWARDSHIP.
HOI DO WE COMMUNICATE AND IMPART
OUR KNOWLEDGE TO IMPACT MENTAL
HEALTH AND END BY SHOWING HOW
WE'RE WORKING TO EXPAND
NUTRITION SCIENCE OUTSIDE THE
NIH AND INTERNALLY.
THEN OUR CROSS-CUTTING
PRIORITIES FOCUS ON TRAINING AND
OPTIMIZING NUTRITION ACROSS THE
LIFE SPAN RECOGNIZING THERE ARE
CRITICAL PERIODS AND SENSITIVE
PERIODS ACROSS THE LIFE SPAN
WHERE NUTRITIONAL NEEDS COULD BE
DIFFERENT AND UNDERSTANDING THE
NEEDS THROUGHOUT THE LIFE SPAN
AFFECT THE ABILITY TO BE MORE
PRECISE IN DIETARY
RECOMMENDATIONS.
SO TO GET A BIT MORE IN DEPTH ON
THE GOALS, GOAL ONE ADVANCING
SCIENCE.
AGAIN, I'M NOT GOING TO READ ALL
THESE VERBATIM BUT OUR FIRST
OBJECTIVE IS TO IMPROVE RIGOR
AND REPROABILDUCIBILITY AND YOU
HEAR ABOUT OUR EMPHASIS ON THIS
AND ONLY BY DOING THAT CAN WE
HOPE TO ADVANCE THE FUNDAMENTAL
UNDERSTANDING OF NUTRITION IN
ALL BIOLOGICAL SYSTEMS.
RESEARCH OBJECTIVE TWO IS TO
ENHANCE THE PRECISION OF
PRECISION SCIENCE.
IT'S POWERED BY THE ALL OF US
RESEARCH ACTIVITY ONGOING AND
WANT TO HARNESS WHAT'S GOING ON
IN THE ACTIVITY AND INITIATIVE
TO MOVE THE FIELD FORWARD.
AND THE THIRD IS UNDERSTANDING
ALL THE CHANGES THAT ARE
HAPPENING IN THE ENVIRONMENT AND
ACROSS THE WORLD AND IN FOOD
SYSTEMS HOW DO WE ENSURE THAT
THERE'S ADEQUATE NUTRITIONAL
SUPPORT TO PROMOTE GROWTH AND
DEVELOPMENT.
MOVING ON TO GOAL 2, SUPPORTING
THE GENERATION OF EVIDENCE.
THE FIRST OBJECTIVE REALLY IS TO
HONE IN ON THE APPROACHES TO
ASSESS NUTRITIONAL STATUS TO
IDENTIFY WHEN AN INDIVIDUAL IS
MALNOURISHED.
MALNUTRITION BELIEVE IT OR NOT
IN 2025 THERE'S NO UNIFIED
DEFINITION OF WHAT IT MEANS TO
BE MALNOURISHED AND NO UNIFIED
APPROACH TO ASSESSING
NUTRITIONAL STATUS OR MAKING
ATTRIBUTIONS TO ONE'S
NUTRITIONAL STATUS.
THERE'S A PROJECT WHERE WE'RE
FOCUSSING ON HOW DOES ONE DEFINE
NUTRITIONAL STATUS IN
MALNUTRITION BECAUSE THAT REALLY
IMPACTS FOOD AS MEDICINE
ACTIVITIES AND INFORMS PRECISION
NUTRITION AND ALL OTHER
ACTIVITIES.
AND THE SECOND OBJECTIVE IS
SUPPORTING THE SCIENCES THAT CAN
INFORM REGULATORY DECISION
MAKERS.
BACK ON MAY 9 THERE WAS AN
ANNOUNCEMENT OF A JOINT PROGRAM
BETWEEN THE NIH AND FDA FOCUSSED
ON NUTRITION REGULATORY SCIENCE
AND THAT REALLY STEMMED FROM AN
OBSERVATION AND RECOGNITION THAT
THERE IS A PAUCITY OF RIGOROUS
DATA THAT CAN HELP INFORM
DECISION MAKERS IN THIS SPACE SO
THAT'S WHAT WE HOPE TO LEVERAGE
AT THE NIH INFRASTRUCTURE AND
SYSTEMS TO REALLY SUPPORT THE
SCIENCE TO INFORM OUR OTHER
FEDERAL PARTNERS.
GOING ON TO GOAL THREE IS
BUILDING CAPACITY AND STRENGTHEN
SCIENCE.
THIS GOES BACK TO THE NOTION OF
NUTRITIONAL STATUS AS BEING A
FUNDAMENTAL BIOLOGICAL VARIABLE
IN ALL BIOMEDICAL SCIENCES AND
ENHANCE CAPACITY AND ENHANCEMENT
ACROSS THE WORKFORCE IN
NUTRITION SCIENCE WORKFORCE AS
WELL AS A WORKFORCE THAT TAKES
IT FROM THE CLINIC TO THE PUBLIC
AND THOSE ARE THE REGISTERED
DIETITIANS WHICH I HAVE THE
UTMOST PROFOUND RESPECT FOR
BECAUSE THAT COMMUNITY TAKES ALL
THE INFORMATION AND MAKES IT
REAL TO INDIVIDUALS AT THE
BEDSIDE AND IN THE HOME.
THEN TO CLOSE OUT WITH OUR
FOURTH GOAL AS FAR AS
STEWARDSHIP AND COLLABORATION
AND TRANSPARENCY AND
ACCOUNTABILITY IS BE THAT
SYNERGISTIC HUB TO FACILITATE
AND LEAD EFFORTS ACROSS THE
GOVERNMENTS AND ACROSS NON
GOVERNMENT PARTNERS.
TO REALLY INCREASE KNOWLEDGE AND
GENERATE INTEREST IN NUTRITION
SCIENCE.
IN A LARGE PART IT'S DONE BY HOW
WE COMMUNICATE NUTRITION AND THE
RESULT OF STUDIES TO THE GENERAL
PUBLIC.
AND THEN THE FOURTH OBJECTIVE
BEING TO EXPAND THE IMPACT OF
OUR ACTIVITIES OF PROGRAMS AND
CAPABILITIES.
I'LL TOUCH ON THAT AT THE END.
AND IN 2020 UNDER CHRIS LYNCH'S
LEADERSHIP THERE WAS A 2020-2030
STRATEGIC PLAN FOR NUTRITION
RESEARCH.
OUR GOAL WAS TO BE SYNERGISTIC
AND COMPLEMENT THE NIH WIDE
STRATEGIC PLAN AND HOW CAN OUR
OFFICE ACTIVITIES IMPACT AND
IMPLEMENT THE OVER ALL NIH WIDE
NUTRITION PLAN.
AND DEMONSTRATE HOW OUR PLAN
MAPS WITH THE NIH OVER ALL PLAN
AND UNIFYING THE THEME OF THE
PLAN BEING PRECISION NUTRITION.
AND NOT ONLY TO SUPPORT THE
SCIENCE AND DO THE WRITING AND
BE ON THE MEETINGS, LEAD THE
INITIATIVES AND SPEAK OFF CAMPUS
TO HELP OUR EXTRAMURAL COMMUNITY
BUT AM A FIRM BELIEVER IN DOING
SOMETHING IN OUR OWN BACK YARD
AND WE HAD A TEACHING KITCHEN
PROGRAM ON CAMPUS.
IT'S ONE THING TO BE WRITING
ABOUT HOW TO IMPROVE NUTRITION
AND WHAT DIETARY PATTERNS MAY BE
BENEFICIAL TO SOMEONE'S HEALTH
BUT IT'S ALSO IMPORTANT TO SHOW
PEOPLE HOW TO TAKE THE
INFORMATION AND WE WENT TO THE
CHILDREN'S INN AND TALK ABOUT
DIET AND NUTRITION AND TEACH
SKILLS AND HAVE EXPERIENTIAL
LEARNING AND WE TEACH KNEW
TRYING AND SHOW PEOPLE HOW TO
TAKE IT BACK TO THE KITCHEN AND
MAKE A MEAL THAT'S HEALTHY.
THAT'S BEEN ONE OF THE
HIGHLIGHTS OF THE PAST MANY
MONTHS HERE IN OUR OFFICE.
AND WITH THAT I'M GOING TO PIVOT
TO THE OFFICE OF DIETARY
SUPPLEMENTS WHO IS CELEBRATING A
BIG BIRTHDAY THIS YEAR IN 30
YEARS, LET'S HEAR IT,
UNBELIEVABLE?
I LIKE THE CLAPPING.
YEAH, SO BACK IN APRIL I AGAIN
EXTRAORDINARY PRIVILEGE OF
JOINING THE OFFICE OF DIETARY
SUPPLEMENTS.
NOT NEW TO THEM AT ALL AS YOU'LL
HEAR THERE'S LOTS OF SYNERGIES.
I HAD THE PRIVILEGE OF
INTERACTING WITH THE OFFICE.
BEING INVOLVED IN THE OFFICE AND
BEING ENGAGED SHOWCASED HOW
EXTRAORDINARY THEY ARE.
HAPPY BIRTHDAY.
SO THE CHARGE OF THE OFFICE OF
DIETARY SUPPLEMENTS IS A BIT
DIFFERENT.
WHEN I TALKED ABOUT NUTRITION
AND HOW ENVISION NUTRITION IS
THE BIOLOGY OF WHAT HAPPENS
AFTER YOU INGEST SOMETHING TO
WHAT HAPPENS AT THE CELLULAR
LEVEL AND FOR A HEALTH OUTCOME.
THE OFFICE IS FOCUSSED ON THE
SUPPLEMENT OR THE NUTRIENT OR
THE INPUT, IF YOU WILL, OF
WHAT'S BEING INGESTED.
SO THE OFFICE THE DIETARY
SUPPLEMENT HEALTH AND EDUCATION
ACT WAS PASSED IN '94 BUT THE
OFFICE ITSELF WAS ESTABLISHED IN
'95.
AND THE LEGISLATIVE PURPOSE OF
THE OFFICE IS TO EXPLORE THIS TO
IMPROVE HEALTH CARE AND I'LL
SHOW YOU IN THE NEXT SLIDE IT'S
A BIG BUSINESS.
AND FROM WHAT THE SCIENTIFIC
STUDY OF BENEFITS IN IMPROVING
HEALTH AND PREVENTING DISEASE
AND THEY'RE SIMILAR TO THE
OFFICE OF NUTRITION SUPPORT TO
SUPPORT THE SCIENCE IN A DIETARY
SUPPLEMENT SPACE THAT'S GOING TO
MOVE THE NEEDAL FORWARD AND TO
BE ADVISORS TO KEY LEADERS IN
THIS SPACE RECOGNIZING THAT
DIETARY SUPPLEMENTS IS A BIG
COMPONENT OF THE AMERICAN DIET.
JUST SOME HOUSEKEEPING HIGH
LEVEL FACT TO THE RIGHT THE
OPERATING BUDGET IS $28.5
MILLION.
THE CURRENT STAFF IN THE OFFICE
IS 22.
THE OFFICE HAS BEEN VERY BROAD
IN THEIR REACH AND THEY SUPPORT
A DIETARY SUPPLEMENT RESEARCH IN
20 INSTITUTES AND CENTERS OVER
THE PAST 10 YEARS.
JUST TO PUT CONTEXT TO THE
ENGAGEMENT OF THE OFFICE AND THE
SUPPORT OF THE OFFICE ABOUT $300
MILLION SPENT ON DIETARY
SUPPLEMENT RELATED RESEARCH AND
THE OFFICE DIRECTLY CO-FUNDS
APPROXIMATELY 50 AWARDS A YEAR
GOING TO $8.5 MILLION PER YEAR.
JUST LIKE THE OFFICE OF
NUTRITION RESEARCH THE OFFICE OF
DIETARY SUPPLEMENTS HAS AN
EXTREMELY BROAD REACH WHICH IS
NOT SURPRISING GIVEN THE EXTENT
DIETARY SUPPLEMENTS ARE USED IN
THE U.S. AND BEYOND AND REALLY
THEY'RE MAJOR FOCUS IS TO
ELUCIDATE THE ROLE OF DIETARY
SUPPLEMENTS IN OPTIMIZING
HEALTH.
THIS IS MORE FOR YOUR RECORDS
AND I PROMISE I WILL NOT WALK
YOU THROUGH EVERYTHING.
THE OFFICE HAS HAD EXTRAORDINARY
ACCOMPLISHMENTS IN THE PAST 30
YEARS.
IT'S TRULY A PRIVILEGE TO BE A
PART OF IT AND I WANTED TO CALL
OUT AND HIGHLIGHT THE RECENT
DIRECTOR WHO SPENT WELL OVER AU
YEAR THINKING ABOUT HOW THE
OFFICE COULD MOVE FORWARD IN A
WAY THAT HAD TREMENDOUS
SCIENTIFIC IMPACT.
SO I HAD THE PRIVILEGE OF
SPEAKING TODAY BUT STEPHANIE
GEORGE THE DEPUTY DIRECTOR AND
ALL THE MEMBERS OF THE OFFICE
ALL THE CREDIT GOES TO THEM.
I GET THE PRIVILEGE OF BEING THE
VOICE BUT THEY DID ALL THE WORK.
AS I ITERATED DIETARY
SUPPLEMENTS ARE A LARGE PART OF
THE U.S. DIET.
ALMOST TWO-THIRDS OF ADULTS AND
A THIRD OF CHILDREN IN THE
U.S. USE DIETARY SUPPLEMENTS.
IF YOU LOOK AT THE GROWTH OF
THEIR USE IN SALES OVER THE PAST
30 YEARS THERE'S ABOUT 4,000
PRODUCTS ON THE MARKET AND NOW
THERE'S OVER 90,000 PRODUCTS ON
THE MARKET.
THE SCIENCE THE OFFICE DOES IS
NOT CHARGED THE OFFICE IS NOT
CHARGED WITH REGULATORY
DECISIONS REGARDING DIETARY
SUPPLEMENTS BUT RATHER THE
OPPORTUNITY THE OFFICE HAS IS TO
ENHANCE THE SCIENCE AND SUPPORT
AND THEN INFORM DECISION MAKERS
WHEN THEY'RE ASKED TO MAKE
DECISIONS.
YOU CAN SEE JUST THE EXPONENTIAL
INCREASE IN THE AMOUNT OF OUT
PRODUCTS AND SALES OF PRODUCTS
OVER THE PAST 30 YEARS.
S MUCH LIKE THE OFFICE OF
NUTRITION RESEARCH ODS IS
MISSION DRIVEN.
THERE'S THREE MAJOR GOALS OF THE
OFFICE TO ADVANCE DIETARY
SUPPLEMENT SCIENCE AND ENHANCING
THE SCIENCE WILL MAKE A
DIFFERENCE AND MOVE THE NEEDAL
FORWARD.
EXPANDING CAPACITY AND REALLY TO
STRENGTHEN THE FIELD OF SCIENCE
AND ADDRESS EMERGING PUBLIC
HEALTH CONCERNS AND AGAIN WHAT
IS THE ROLE OF DIETARY
SUPPLEMENTS BUT TO HELP MAKE
AMERICA HEALTHIER AGAIN AND
FOSTER STEWARDSHIP AND
COLLABORATION AND YOU SEE
ALIGNMENTS BETWEEN THE TWO
OFFICES WITH WHAT WE ARE TRYING
TO DO INTERNALLY AT THE NIH WITH
OFFICES.
I FLUSHED OUT WHAT THE GOALS ARE
FOR ODS.
FIRST LIKE ONR IS RESEARCH.
ADVANCING THE STUDY OF THE
BIOLOGICAL EFFECTS OF DIETARY
SUPPLEMENTS.
HERE'S WHERE IT'S NUANCED.
ON RESILIENCE AND HEALTH ACROSS
THE LIFE SPAN.
HOW CAN DIETARY SUPPLEMENT USE
FACILITATE RESILIENCE AND THE
ABILITY TO MAINTAIN HEALTH
ACROSS THE LIFE SPAN THAT'S ADD
AN INDIVIDUAL AND POPULATION
LEVEL.
WITH ALMOST TWO-THIRDS OF ADULT
AND A THIRD OF CHILDREN TAKING
DIETARY SUPPLEMENT IT'S NOT AN
INDIVIDUAL ISSUE BUT POPULATION
ISSUE.
THEN ADVANCING THE SCIENCE ON
THE STABILITY, EFFICACY AND
SAFETY OF DIETARY SUPPLEMENTS IS
SOMETHING EXTREMELY IMPORTANT
AND THE OFFICE HAS BEEN ENGAGED
IN IS THE ANALYTICS OF DIETARY
SUPPLEMENTS.
AS FAR AS RESEARCH CAPACITY
YOU'LL HEAR MORE FROM ADAM ABOUT
ALL THE EFFORTS AND NOVEL
EFFORTS THE OFFICE IS PUTTING
FORWARD.
REALLY TRYING TO STRENGTHEN AND
HARMONIZE METHODOLOGICAL
APPROACHES TO PROMOTE SCIENTIFIC
BEST PRACTICES.
WE WANT TO ACHIEVE THAT GOLD
STANDARD OF SCIENTIFIC RIGOR AND
REPRODUCIBILITY IN THE NUTRITION
SCIENCES AND DIETARY SUPPLEMENT
OFFICES AND KUDOS FOR THOSE
INVOLVED USING THE DATABASES AND
PREPARING FACT SHEETS.
WHAT THE OFFICE SUPPORTS ARE A
TREMENDOUS NATIONAL RESEARCH
THAT ARE INVALUABLE.
AS FAR AS STEWARDSHIP MAKING
SURE IT'S TRANSLATABLE AND
ACCESSIBLE TO THE PUBLIC.
THE FACT SHEETS ARE ACCESSED
THOUSANDS OF TIMES A DAY.
AND IS THE MOST ACCESSED PART OF
THE ODS WEBSITES BUT THOSE ARE
FIRST OF ALL UPDATED BY A TEAM
AND USED BY PRACTITIONERS AND BY
THE GENERAL PUBLIC.
THEY SERVE A MYRIAD OF REASONS
AND WRITTEN AT THE APPROPRIATE
LEVEL THEY CAN BE ACTIONABLE AND
TRANSLATABLE TO A GIVEN
AUDIENCE.
AND ALSO ROUNDING OUT THE LAST
BULLET, COORDINATING AND
SUPPORTING WORKFORCE AND
PROFESSIONAL DEVELOPMENT.
A THEME IN THE OFFICE IS HOW TO
TRAIN INDIVIDUALS TO DO RIGOROUS
SCIENCE IN THE SPACE AND MAKE
THEM TRANSLATABLE AND
ACTIONABLE.
AND ONE IS HEALTHY AMERICANS AND
ALL OF US WANT TO MAKE AMERICANS
HEALTHY AND WHAT IS THE ROLE OF
DIETARY SUPPLEMENTS IN THAT
SPACE AND WE WANT AMERICANS
HEALTHY THROUGHOUT THE ENTIRE
LIFE SPAN.
SO YOU HEAR ME TALK ABOUT
NUTRITION THROUGHOUT THE LIFE
SPAN BUT WHAT ARE THE ROLE OF
DIETARY SUPPLEMENTS IN ADDITION
TO PATTERNS TO OPTIMIZE HEALTH
IN CRITICAL PERIODS OF LIFE
WHERE NEEDS COULD BE DIFFERENT
WHETHER THE NICU OR THE
2-YEAR-OLD OR 7-YEAR-OLD OR
PUBERTAL BOY OR PREGNANT WOMAN
OR 85-YEAR-OLD WITH OTHER HEALTH
ISSUES.
ALL THE OPTIONS HAVE NUANCE D S
AND WHAT IS THE ROLE OF DIETARY
SUPPLEMENTS AND HOW CAN THEY BE
USED TO OPTIMIZE HEALTH AND FACE
RESILIENCE IN THE FACE OF
STRESSORS.
HE CAN TALK FOR WEEKS IT'S
AMAZING AND HE'S CAFFEINATED.
WATCH OUT.
ODS HAS HAD LONG STANDING
SUPPORT OF OTHER PROGRAMS THAT
HITS WHERE WE ARE TODAY IN
ENHANCING RIGOR AND
REPRODUCIBILITY AND
METHODOLOGIES.
I'D LIKE TO DO A SHOUT OUT TO
THE GROUP FOR BEING AHEAD IN
THESE SPACES BECAUSE I'LL CALL
OUT THE ANALYTICAL METHODS AND
THE CARBON PROGRAM AS BEING
THINKING ABOUT THESE SPACES NOT
JUST NOW BUT FOR THE PAST 10
PLUS YEARS.
MANY PROGRAMS FOCUS ON
TRANSLATABILITY AND HOW CAN THE
SCIENCE BE DONE IN A RIGOROUS
AND REPRODUCIBLE FASHION AND HOW
CAN THAT BE TRANSLATABLE TO
IMPACT PUBLIC HEALTH IN A
BENEFICIAL MANNER HAS BEEN AN
OVER ARCHING THEME SINCE THE
OFFICE'S EXISTENCE.
AND I WAS CHATTING WITH ADAM AND
BORROWED THIS QUOTE FROM HIM
YOU'LL HEAR FROM NEXT AND JUST
LIKE WE GUIDE PRINCIPLES FOR THE
OFFICE OF NUTRITION RESEARCH I
WAS THINKING WHAT'S A GREAT
PRINCIPLE FOR DIETARY SUPPLEMENT
AND THE TRANSLATION FROM STUDIES
STUDYING THE MECHANISTIC HEALTH
EFFECTS OF SUPPLEMENT TO INFORM
HEALTH CARE PRACTICES TO MAKE
THIS ACTIONABLE TO INFORM
PRACTICES IN INDIVIDUAL'S
DECISIONS TO USE OR AVOID
SUPPLEMENTS REQUIRES RIGOROUS
EVIDENCE BASE THAT'S IN THE PEER
REVIEWED LITERATURE AND THAT'S
WHAT WE STRIVE FOR TO SUPPORT
THE SCIENCE TO GENERATE THE DATA
TO INFORM THE DECISION MAKERS
WHETHER IT BE REGULATORY OR THE
PHYSICIAN FOR THE INDIVIDUAL
DECIDING WHETHER OR NOT TO TAKE
A DIETARY SUPPLEMENT.
AND WITH THAT IT'S A PLEASURE TO
INTRODUCE ADAM FOR DIETARY
SUPPLEMENTS.
IN THE GOVERNMENT IF YOU'RE
GOING TO HAVE THE INITIATIVE YOU
HAVE TO HAVE A COOL ACRONYM AND
HE DID A SPECTACULAR JOB WITH
RIGOR BECAUSE THAT'S WHAT WE'RE
ABOUT, RIGOR, REPRODUCIBILITY
AND I KNOW I SPOKE FOR 35
MINUTES STRAIGHT BUT I WANTED TO
GIVE YOU TIME BACK.
1
>> THANK YOU FOR ACCELERATING TO
ALLOW TIME FOR AT THE END.
>> I'LL ASK TO YOU COMMENT ON
THE SCIENTIFIC REASONS FOR
TREATING SUPPLEMENT AL
SUPPLEMENTS FROM OTHER COMPOUNDS
AND DRUGS AND I'VE BEEN
CONCERNED THEY DO MORE HARM THAN
GOOD AND THERE'S NO REQUIREMENTS
TO PROVE SAFETY BEFORE YOU SELL
THEM IS A DANGEROUS REALITY.
I WANT TO HEAR ABOUT THE REASONS
WHY THE NIH TREATS THEM
SEPARATELY.
WHY AREN'T THEY TREATED LIKE ANY
OTHER DRUG OR COMPOUND?
>> I'LL TALK ABOUT THE NIH
VERSUS THE FDA THE HIGH LEVEL IS
FOOD IS MORE IN THE FOOD THAN
DRUG CATEGORY AND HAVE DIFFERENT
PATHWAYS.
THE OFFICE SINCE ITS INCEPTION
HAS BEEN CHARGED TO SUPPORT THE
SCIENCE TO THEN INFORM DECISION
MAKERS AND WHERE I THINK YOU'RE
GOING IS WITH REGULATION AND
THAT FALLS UNDER THE PURVIEW OF
THE FDA.
ONE OF OUR GOALS IS TO ENHANCE
THE SCIENCE TO ENHANCE OUR
COLLEAGUES AT THE FDA.
>> THANK YOU FOR THE OVERVIEW
AND IF YOU SELL BOTTLES OF YOUR
ENTHUSIASM SIGN ME UP.
>> THIS IS NOTHING.
WAIT UNTIL LATER.
>> I'M A CLINICIAN AND
OPHTHALMOLOGIST, WE HAD THE
BENEFIT OF THE ARAD STUDIES 40
OR 50 OF THEM WHICH I KNOW YOUR
OFFICE HELPED SUPPORT OVER THE
YEARS.
WHEN I SIT WITH THE PATIENT AND
ADVISE THEM THEY SHOULD BE
TAKING A COMBINATION OF VIT
MAYBES A, E, ZINC AND COPPER I
HAVE PHENOMENAL DATA UND
UNDERGIRDING THAT DISCUSSION AND
PROSPECTIVE RANDOMIZED CONTROL
TRIALS WITH CLEAR END POINTS AND
FROM A REPRODUCIBILITY END POINT
YOU JUST CAN'T GET MUCH BETTER
THAN THAT IN THE SPACE.
IN LOOKING THROUGH YOUR
STRATEGIC PLAN I ONLY SEE THE
WORDS CLINICAL TRIAL MENTIONED
FOUR OR FIVE TIMES.
NHANES IS INHERENT CHALLENGES IN
THAT AS A DATA RESOURCE.
IT WILL BE DIFFICULT FOR THE
PUBLIC AND IT'S DIFFICULT FOR
PHYSICIANS TO MAKE SENSE OF
THAT.
CAN YOU GIVE ME A SENSE OF WHERE
IN THE PRIORITY CHAIN SUPPORTING
ADDITIONAL RANDOMIZED CONTROL
TRIALS OF SUPPLEMENTS AND/OR
NUTRITIONAL ROUTES SITS WITHIN
THE OFFICE WHEN YOU PRIORITIZE
YOUR PROGRAMATIC OPTIONS?
>> THANK YOU FOR THE QUESTION.
AND ARAD IS A GREAT EXAMPLE OF
AND THEN INFORM CLINICAL IMPACT
AND TO YOUR POINT AND HAVE A
CLINICIAN BE CONFIDENT IN THE
RECOMMENDATIONS THEY'RE MAKING.
I LOOK AT THE END POINTS AND
WHAT THE ANTICIPATED OUTCOMES
AND WHAT THE METRICS WOULD BE
SOMETIMES I DON'T LIKE THE WORD
ONE OFF BUT THINKING ABOUT THE
BIG TRIALS THAT NEED TO BE DONE
TO INFORM THE PATIENT
POPULATION.
>> WE SPENT THE MORNING TALKING
ABOUT BIG DATA AND WAYS OF
MANAGING LARGE DATA SETS.
THE CHALLENGE WITH THOSE DATA
SETS IS WITH 90,000 SUPPLEMENS
AND SO MANY END POINTS THEY'RE
UNACCOUNTABLE.
THE FALSE DISCOVERY RATE IS
TREMENDOUSLY HIGH AND THAT
INTRINSICALLY LOWERS AND GOLD
STANDARD SCIENCE IS GOLD
STANDARD SCIENCE.
>> THANK YOU FOR THE COMMENT,
RUSS.
>> DEFINITE IN THE INTEREST OF
TIME WE SHOULD MOVE ON.
WE'RE NOW MOVING TO AN ODS
PROGRAM UPDATE ON IMPROVING THE
RIGOR AND REPRODUCIBILITY OF
DIETARY SUPPLEMENT RESEARCH BY
ADAM KUSZAK.
>> THANK YOU FOR THE OPPORTUNITY
TO UPDATE THE PROGRAM
ACTIVITIES.
THE PRIOR CONVERSATION COULDN'T
HAVE TEED ME UP BETTER ON THIS.
I'LL HAVE A SYNOPSIS OF THE
APPROACHES WE'RE ESTABLISHING TO
FOSTER GREATER KNOWLEDGE OF
DIETARY SUPPLEMENT HEALTH
EFFECTS.
>> I'VE GIVEN YOU PERMISSION TO
MOVE YOUR OWN SLIDES.
THE CURRENT LANDSCAPE OF THE
DIETARY SUPPLEMENT RESEARCH
INCLUDES A BREADTH OF NIH
INVESTMENT, A NUMBER OF GOOD
PRACTICE GUIDELINES WITH VARY
AND APPLICABILITY TO DIETARY
SUPPLEMENTS AND HISTORY OF ODS
AND BROADER NIH RESEARCH
SUPPORTING RIGOR AND
REPRODUCIBILITY.
EVEN SO, INHERENT CHALLENGES IN
CONDUCTING TRANSLATABLE
INTERVENTION RESEARCH ALONG WITH
THE CHEMICALLY COMPLEX
FORMULATION ARE DIETARY
SUPPLEMENTS HAS YIELDED AN
EVIDENCE BASE THAT CAN BE JUDGED
AS HETEROGENEOUS AND DIFFICULT
TO GENERALIZE TO PUBLIC HEALTH
OUTCOMES.
ODS IS ADDRESSING THE STATE OF
THE SCIENCE AS AN OPPORTUNITY
FOR EXPANDED PROGRAM ACTIVITIES
DEVELOPING REPRODUCIBILITY AND
INTEGRITY GUIDANCE TO OPTIMIZE
RESEARCH FOR DIETARY GUIDANCE.
I'LL INTRODUCE ACTIVITIES
GUIDANCE AND PORTFOLIO ANALYSES
WITH THE GOALS OF IDENTIFYING
AND PRIORITIZING RESEARCH AND
RESOURCE NEEDS.
THESE ACTIVITIES WILL DRIVE NEW
SERVICES TO STIMULATE RIGOR AND
COMPARABILITY AND REPLICABILITY
TOWARD A VISION OF A MORE ROBUST
EVIDENCE BASE.
I APPRECIATE DR. BREM ER'S
UPDATE EARLIER.
WITH PARTNERS AND COLLEAGUES
ACROSS NIH WE HAVE TRANSLATION
TO CATALYZE RESEARCH AND SUPPORT
CAPACITY BUILDING.
ABOUT A YEAR AGO NOW IN THINKING
ABOUT THE RESEARCH PORTFOLIO AND
WHERE TO AMPLIFY OUR PROGRAM
EFFORTS, WE ASKED WHAT MORE
COULD ODS TO INCREASE THE
STRENGTH AND RELIABILITY OF
DIETARY SUPPLEMENT SCIENCE.
THE NIH'S RESEARCH PORTFOLIO
RELEVANT TO UNDERSTANDING THE
HEALTH EFFECTS COVERS A LARGE
BREATH OF PHYSIOLOGICAL SYSTEMS
AND HEALTH CONDITIONS.
WITH MECHANISMS OF ACTION AND
SUPPLEMENTS IN DISEASE STATE
OUTCOMES.
AND TRANSLATION OF THE
MECHANISTIC AND HEALTH OUTCOMES
RESEARCH TO INFORM HEALTH CARE
PRACTICES AT THE INDIVIDUAL
LEVEL TO USE OR AVOID
SUPPLEMENTS AND AT THE
POPULATION LEVEL FOR CLINICAL
PRACTICE REQUIRES THAT RIGOROUS
EVIDENCE BASE THAT'S
REPRODUCIBLE AND ACCURATELY
REPORTED.
I COULDN'T HAVE SET UP THE
CONVERSATION BETTER IN THE PRIOR
CONVERSATION.
THERE'S SEVERAL EXAMPLES OF
WHERE A ROBUST EVIDENCE BASE FOR
DIETARY SUPPLEMENT HEALTH
AFFECTS WILL BE ESTABLISHED AND
ONE GOOD EXAMPLE IS THE
AGE-RELATED EYE DISEASE STUDIES
LED BY THE NATIONAL EYE
INSTITUTE WHERE A WELL DEFINED
DIETARY INGREDIENT FORMULATION
WERE THOROUGHLY TESTED AND
REFINED THROUGH RTCs AND STUDIES
HAVE CONFIRMED BENEFICIAL
EFFECTS ON SLOWING MACULAR
DEGENERATION AND ADDITIONAL
BENEFITS AND STAGES OF MACULAR
DEGENERATION.
SIGNIFICANT FINDINGS, METHOD
LOGICALLY EXPANDED UPON THROUGH
APPROACH AND RIGOROUS STUDY
DESIGN AND TRUSTWORTHY SCIENCE
CONFIDENTLY COMMUNICATED TO THE
PUBLIC.
AT THE SAME TIME THERE'S
CHALLENGES TO DIETARY SUPPLEMENT
RESEARCH.
STUDIES THAT ARE EXCLUDED FROM
SYSTEMIC REVIEWS AND
META-ANALYSES ARE OFTEN TELLING
THE LIMITATIONS ARE COMMONLY
CITED SUCH AS RANDOMIZATION OR
NO BLINDING, LACK OF VALIDATED
BIOMARKERS OR IRRELEVANT HEALTH
OUTCOME MEASURES AND DURATION OR
NO FOLLOW-UP UNDERMINING
RESEARCH COMPARABILITY.
IN ADDITION TO THESE BROADER
BIOMEDICAL RESEARCH CHALLENGES,
DIETARY SUPPLEMENT STUDIES MUST
ALSO CONTEND WITH CHALLENGES IN
ASSESSING INTAKE AND STATUS AS
WELL AS DIFFICULTIES IN
INTERPRETING AND COMPARE RESULTS
ACROSS NUMEROUS INGREDIENT
FORMULATIONS THAT CAN BE
THOROUGHLY OR MINIMALLY
CHARACTERIZED OR ANYWHERE IN
BETWEEN.
ODS ASKS HOW TO IMPROVE EFFORTS
OF RELATED NUTRITIONAL RESEARCH
AND HOW CAN ODS PROMOTE
COMPARABILITY AN GREATER
REPRODUCIBILITY AND WHAT ARE
ADDITIONAL APPROACHES TO
IDENTIFY AND PRIORITIZE NEEDS
AND OPPORTUNITIES FOR ADVANCING
ANALYTICAL SCIENCES AND
INCREASING RESEARCH CAPACITY.
AND PROMOTE FURTHER PROGRESS IN
THE RIGOR WITH WHICH DIETARY
SUPPLEMENT STUDIES ARE DESIGN,
CONDUCTED, EVALUATED AND
REPORTED.
AND INTEGRITY GUIDANCE TO
OPTIMIZE RESEARCH FOR DIETARY
SCIENCE OR RIGOR.
RIGOR INCLUDES A FEW INITIATED
AND PLANNED ACTIVITIES.
ODS WILL ENGAGE WITH THE
RESEARCH COMMUNITY TO CLARIFY,
ELABORATE AND UPDATE
RECOMMENDATIONS FOR CHEMICALLY
CHARACTERIZING DIETARY
SUPPLEMENT INGREDIENTS AND
PRODUCTS USED AS EXPERIMENTAL
AND CLINICAL INTERVENTIONS.
AROUND TO BETTER UNDERSTAND HOW
NIH CAN PROMOTE WELL FORMULATE
AND COMPARABLE ACROSS THE FIELD.
AND ODS IS LEADING A
CHARACTERIZATION OF THE
PORTFOLIO OF NIH SUPPLEMENT
RESEARCH AS A FIRST STEP TOWARDS
IDENTIFYING CAPACITY BUILDING
NEEDS WHERE NEW RESOURCES CAN
FURTHER ENCOURAGE WELL
CONTROLLED DESIGNS THAT FOR
EXAMPLE REDUCE MEASUREMENT BIAS
OR FACILITATE THE DEVELOPMENT OF
VALIDATED BIOMARKERS AND OUTCOME
MEASURES.
IT HOLDS TRUE WHEN THEY'RE DONE
WITH BOTANICALS AND NATURAL
PRODUCTS AND OTHER DIETARY
INTERVENTIONS THE DATA WILL BE
IRREPRODUCIBLE AND DIFFICULT TO
INTERPRET.
FOLLOWING STEPS FROM COLLEAGUES,
ODS HAS IMPLEMENTED NATURAL
PRODUCT AND DIETARY SUPPLEMENT
INTEGRITY GUIDANCE TO AID IN THE
DESIGN AND EVALUATION OF
RESEARCH.
THESE GUIDELINES EMPHASIZE THE
IMPORTANCE OF CHARACTERIZING THE
SUPPLEMENT UNDER INVESTIGATION
FOR ITS CHEMICAL COMPOSITION,
IDENTITY AND AUTHENTICITY AND
STABILITY AND ALL FOR A
REPRODUCIBLE PREPARATION.
WE ALSO FOUND IN THAT TIME THE
GUIDELINES HAVE NOT ALWAYS BEEN
CONSISTENTLY COMMUNICATED IN A
CLEAR AND ACTIONABLE MANNER.
AS SUCH WE WILL NOT ONLY UPDATE
THE GUIDANCE TO INCLUDE
TECHNICAL ADVANCES AND
CONSIDERATIONS OF METABOLISM AND
BIO AVAILABILITY BUT ODS WILL
WORK WITH PARTNER I.C.s TO
DEVELOP APPROACHES TO DEVELOP
THE GUIDELINES ARE MORE
APPLICABLE AND USEFUL TO THE
BROADER RESEARCH COMMUNITY.
IN THE INITIATING PORTFOLIO
ANALYSIS ACTIVITIES WE ARE
PARTNERING WITH COLLEAGUES
ACROSS THE DIVISION AND ASKING
TO WHAT EXTENSION IT'S FOCUSSED
ON HEALTH OPTIMIZATION,
RESILIENCE AND THE PREVENTION OF
CHRONIC DISEASES COMPARED TO
MECHANISMS, METABOLISM OR
DISEASE MANAGEMENT TOPICS AS
EXEMPLIFIED WITH THE SCOPING
ESTIMATES FOR A SMALL COHORT OF
CLINICAL TRIAL STUDIES.
WE'RE ALSO IMPROVING OUR OWN
TOOL KIT IN COLLABORATION WITH
THE OFFICE OF PORTFOLIO ANALYSIS
TO BETTER CHARACTERIZE WHICH
INGREDIENTS AND IMPORTANTLY WHAT
COMBINATIONS OF INGREDIENTS AND
DOSES ARE BEING STUDIED FOR
EFFICACY OR EFFECTIVENESS FOR
DIFFERENT HEALTH CONDITIONS AND
POPULATIONS AND FROM THIS WILL
ENHANCE OUR ABILITY TO IDENTIFY
EMERGING OPPORTUNITY AREAS.
IN THE LOWER RIGHT PRELIMINARY
EXAMPLE HERE WE'RE LOOKING NOT
ONLY AT WHERE CERTAIN VITAMINS
OR PHYTO CHEMICALS ARE BEING
STUDIED BUT WHERE THEY'RE BEING
STUDIED IN COMBINATION.
AND LOOK AT WHERE THEY'VE IN
CERTAIN POPULATIONS AND ASSESS
THE STATE OF SCIENCE WHERE
REPRODUCIBILITY AND
TRANSLATABILITY FROM THE
PERSPECTIVE OF EXPERIMENTAL
MODELS AND DURATION AND OUTCOME
MEASURES.
FOR EXAMPLE, WE CAN CONSIDER
WHERE MEANINGFUL OUTCOME
MEASURES MAY BE LACKING AND
LIMITING THE GENERALIZABILITY OF
DIETARY SUPPLEMENT RESEARCH.
COLLECTIVELY THEY'LL STAND UP
IMPACTFUL APPROACHES TO PROMOTE
THE STUDY OF MORE REPLICABLE
DIETARY INTERVENTIONS AND
ADDRESS METHODOLOGICAL
CHALLENGES.
IN THE LONGER TERM RIGOR AIMS TO
CONSOLIDATE RESEARCH BEST
PRACTICES.
STIMULATE REPRODUCIBLE DIETARY
SUPPLEMENT RESEARCH MORE READILY
TRANSLATABLE TO UNDERSTAND
SAFETY, EFFICACY AND
EFFECTIVENESS AND PROMOTE AN
INCREASINGLY ROBUST EVIDENCE
BASE THAT'S MORE INFORMATIVE AND
ACTIONABLE TO HEALTH CARE
DECISIONS AND CLINICAL
PRACTICES.
I'M VERY GRATEFUL FOR THE
SUPPORT AND CONTRIBUTIONS OF
MANY COLLEAGUES, ODS LEADERSHIP
AND THE ENTIRE ODS TEAM AS WELL
AS PARTNERSHIP WITH COLLEAGUES
FROM NCCIH, ODP, OBSSR AND OPA
AND THANK YOU THE COUNCIL FOR
YOUR TIME.
I APPRECIATE BEING ABLE TO HEAR
YOUR FEEDBACK AND ANSWER YOUR
QUESTIONS.
>> THANK YOU, ADAM.
IF COUNCIL MEMBERS HAVE
QUESTIONS OR COMMENTS, PLEASE
RAISE YOUR HAND.
I APPRECIATE BOTH THE
PRESENTATIONS.
ARE YOU FOCUSSING PRIMARILY ON
DIETARY SUPPLEMENTS THAT ARE
AVAILABLE FROM YOUR DOCTOR OR
OVER THE COUNTER AND I HAVE A
FOLLOW-UP AFTER THAT.
>> FOR THE OFFICE OF DIETARY
SUPPLEMENTS IT'S NOT LIMITED TO
THOSE CATEGORIES.
MAYBE FOR EXAMPLE WHETHER YOUR
DOCTOR PRESCRIBES A PRENATAL
SUPPLEMENT OR CHOOSE TO PURCHASE
ONE FROM THE PHARMACY.
THERE'S NOT A FOCUS ON ONE
CATEGORY OR APPROACH THERE.
>> OKAY.
IN THAT REGARD, UNLESS I MISSED
IT OR YOU DIDN'T SAY IT, I THINK
YOU'RE MAYBE MISSING AN
OPPORTUNITY HERE BECAUSE DIETARY
SUPPLEMENTS THEN PEOPLE CAN GET
THEM FOR SELF-MEDICATION.
SO IF YOU'RE CONDUCTING THE
RESEARCH AND THEN PUBLISHING IT
IN THE SCIENTIFIC REALM, THAT
DOESN'T GET TO THE GENERAL
PUBLIC.
I THINK YOU MIGHT TO CONSIDER
WAYS TO GET WHAT YOU DO OUT TO
THE GENERAL PUBLIC.
AS YOU KNOW, NOT ONLY THERE'S
BENEFITS TO SOME DIETARY
SUPPLEMENTS BUT SOME CLAIMS IN
WHICH THEY'RE RECOMMENDED BUT IF
THEY'RE NOT FROM THEY WON'T BE
SEEN BY THE PUBLIC.
>> IT'S TRUE.
WE'RE ALWAYS LOOKING LOOKING TO
GET PEOPLE THE INFORMATION THEY
WANT AND NEED IN WAYS THEY CAN
WE'RE TRYING TO EXPAND AND
DIGEST THE TOTALITY OF THE
BIOMEDICAL LITERATURE AND BE
ABLE TO SUMMARIZE IT IN A CLEAR
MANNER THAT IF YOU HAVE A
QUESTION, IS THIS INGREDIENT
GOING TO GIVE ME SOME HEALTH
BENEFIT OR IS THERE SOME
POTENTIAL CONCERN FOR A
PARTICULAR CONDITION.
WE REALLY TRY TO RELAY THAT
INFORMATION BEST AS WE CAN AND
IT'S ALSO A PLACE WHERE AS
RESEARCHERS CAN TAKE A LOOK AND
ALSO SEE WHERE THERE'S FURTHER
RESEARCH TO SHED MORE LIGHT ON
THE TOPIC.
FOR EXAMPLE, IN OUR FACT SHEETS
WE DO TALK ABOUT WHERE A FEW
STUDIES NOT VERY LARGE SAMPLE
SIZE VERY DIFFERENT DOSES OR
FORMULATIONS LOOKED AT AND SO
FURTHER INVESTIGATION NEEDED.
>> PLEASE GO AHEAD.
>> THIS MAY BE MORE OF A
QUESTION FOR DR. BREMER AGAIN
BUT AS DR. BREMER IS CURRENTLY
THE ACTING DIRECTOR AND DIRECTOR
OF ODS IN THIS APPARENT SEASON
OF LOOKING FOR OPPORTUNITIES TO
CONSOLIDATE AND SYNERGIZE I'D BE
CURIOUS ON THOUGHTS OF STRENGTHS
AND WEAKNESSES OF HAVING TWO
OFFICES WITHIN DPCPSI THAT HAVE
FAIRLY OVERLAPPING INTERESTS AS
WE'VE DISCUSSED HERE TODAY.
>> THANK YOU FOR THE QUESTION.
I SEE THE OFFICE AS A SPECTRUM.
AND IS THE OFFICE OF DIETARY
SUPPLEMENT AND ONR WORK HAND IN
HAND AND THE TEAM HAVE SPENT A
NUMBER OF YEARS FOCUSSED ON THE
INPUT OF THE DIETARY
SUPPLEMENTS.
THE NUTRITION RESEARCH OFFICE
OUR GOAL IS TO FOCUS ON THE
BIOLOGY.
WHAT INTEREST THE TECHNOLOGICAL
FACTORS AN WHAT HAPPENS AFTER
THE SUPPLEMENT ISS INGESTED GOIG
FROM A FOOD MATRIX TO METABOLIC
MATRIX AND HOW IT'S AFFECTING
CELLULAR FUNCTION AND IMPACTING
HEALTH.
THE DIETARY SUPPLEMENT ASPECT IS
A PART OF THAT CONTINUUM AND
IMPORTANT TO UNDERSTAND WHAT ARE
THE CONSTITUENTS AND INGREDIENTS
AND ABOUT WHAT IS THE FUNCTION
OF WHAT'S GOING IN THE MOUTH AND
HOW DOES THAT TRANSLATE.
HOW DO YOU GO FROM FOOD TO
HEALTH THAT'S THE LINK BETWEEN
WHAT GOES INTO OUR MOUTH AND
WHAT THE HEALTH OUTCOMES ARE TO
DIFFERENTIATE.
IT'S A CONTINUUM BUT A PACKAGE.
>> THANK YOU.
DO ANY OTHER COUNCIL MEMBERS
HAVE QUESTIONS OR COMMENTS
BEFORE WE MOVE TO ANOTHER
DISCUSSION SESSION FOR OUR LAST
15 MINUTES?
OKAY.
SO MOVING BACK TO SOME
ADDITIONAL QUESTIONS THAT WERE
RAISED FOLLOWING THE NIH AND
DPCPSI UPDATES, COUNCIL MEMBERS
HAVE ASKED FOR ADDITIONAL TIME
TO BRING UP OTHER CONCERNS AND
QUESTIONS AND SO WE WILL TAKE
THE NEXT 15 MINUTES TO DO THAT
RECOGNIZING WE'LL LIKELY NOT BE
ABLE TO ADDRESS ALL THE
QUESTIONS COUNCIL MEMBERS HAVE
AND HAVE ASKED THEM TO SUBMIT
THEM IN WRITING THROUGH THE CHAT
FUNCTION AND TO ENSURE THAT WE
PROVIDE THOUGHTFUL AND DETAILED
RESPONSE TO YOUR QUESTIONS.
WE WILL CONSULT WITH THE VARIOUS
OFFICES WITHIN DPCPSI AND OFFICE
OF THE DIRECTOR TO PROVIDE THAT
FEEDBACK AND TO ENSURE IT'S
TRANSPARENT AND PUBLICALLY
ACCESSIBLE WE WILL PROVIDE THE
QUESTIONS AND WRITTEN RESPONSES
AS AN ADDENDUM TO THE MEETING
MINUTES AND THOSE WILL BE POSTED
ONCE THEY'RE REVIEWED AND
APPROVED.
DOES THAT SOUND LIKE AN
ACCEPTABLE WAY FORWARD FOR
COUNCIL MEMBERS.
I SEE NODDING HEADS.
THANK YOU.
SO FIRST, TO START OFF THERE WAS
A QUESTION FROM EARLIER ABOUT
COUNCIL MEMBERSHIP.
TO FOLLOW-UP ON THE MEMBERSHIP
REDUCTIONS IN STAFF MADE IT
DIFFICULT AND OUR CHARTER SHOWS
IT MAY SERVE AFTER THE
EXPIRATION OF THE MEMBER'S TERM
UNTIL A SUCCESSOR HAS LEFT
OFFICE.
GIVEN THE DELAYS IN APPOINTING
REPLACEMENT MEMBERS TO THE
COUNCIL OF COUNCILS WE ASKED
COUNCIL MEMBERS TO EXTEND THEIR
TERMS BY SIX MONTHS.
THESE ADMINISTRATE IIVE PLACEME
HAVE BEEN PROCESSED.
WE'VE NOT HAD AN OPTION TO
EXTEND A MEMBER UNTIL THEY HAVE
A REPLACEMENT AND WE'LL ASK FOR
CLARIFICATION TO DETERMINE WHY
THAT'S NOT BEEN AN OPTION IN THE
PAST.
WE'LL REPORT BACK AT THE NEXT
MEETING THE OUTCOME OF OUR
REQUEST.
IS THERE A FOLLOW-UP QUESTION TO
THAT OR CAN WE MOVE TO THE NEXT
QUESTION?
>> WE CAN MOVE.
>> GREAT.
>> ANY QUESTION IS HAVING JUST
HEARD PEOPLE WERE ASKED THERE
ARE TWO OF US WHOSE TERMS EXPIRE
THIS YEAR AND I DON'T REMEMBER
BEING ASKED.
WE CAN DO IT LATER IF YOU WANT
OR YOU CAN DECIDE NOT TO ASK ME
BUT EITHER ARE FINE.
>> TYPICALLY WE MAKE THOSE
CLOSER TO THE EXPIRATION OF THE
TERM DATE.
>> ALL RIGHT.
I'LL BE PATIENT.
>> THANK YOU.
>> QUESTION NUMBER ONE, IS THAT
OKAY?
>> PLEASE GO AHEAD.
>> SO EARLIER WE ASKED ABOUT
CANCELED GRANTS IN HOPE TO
CLARIFY OUR ROLE IN SECOND LEVEL
REVIEW FOR THE COMMON FUND
PROGRAMS AND YOU IMPLIED PROGRAM
STAFF ARE CONSULTING WITH
ADMINISTERING I.C.s AND
CATEGORIZING AWARDS FOR FUNDING
DECISIONS AND WE'D LIKE SOME
ADDITIONAL CLARIFICATION ABOUT
HOW THESE AWARDS ARE BEING
CATEGORIZED FOR CANCELLATION OR
RECEIPT OF STOP WORK ORDERS.
IN WHAT BASIS ARE THEY BEING
CATEGORIZED AND WHAT ENTITY
DOING THE CATEGORIZATION.
IS THE I.C.s IN COLLABORATION
WITH DOGE AND THERE'S AUTOMATED
PROCESS.
WHAT ASPECTS OF THE GRANT
APPLICATION ARE BEING REVIEWED?
IS IT THE BUDGET, AND HOW ARE
THE I.C. PROGRAM STAFF INVOLVED
IN THE FINAL DECISION MAKING OF
THE STOP WORK ORDERS.
>> THANK YOU FOR THE QUESTIONS.
I'LL PROVIDE A PRELIMINARY
RESPONSE AND THEN WE'LL
FOLLOW-UP IN WRITING WITH
ADDITIONAL FEEDBACK FROM OUR OER
OFFICE OF EXTRAMURAL RESEARCH
COLLEAGUES AS FAR AS THE FORMAL
PROCESS FOR REVIEW AND ALL THE
OTHER DETAILS BEING ASKED HERE.
FROM A HIGHER LEVEL THE GRANTS
ARE BEING REVIEWED BY DOGE.
THEY'VE GONE THROUGH THE BACKLOG
OF GRANTS CATEGORIZED THAT WERE
PAUSED OR FROZEN OR POTENTIALLY
CATEGORIZED FOR TERMINATION.
THEY'RE REVIEWING THEM FOR
COMPLIANCE WITH THE PRESIDENT'S
EXECUTIVE ORDERS.
THOSE GRANTS FLAGGED ARE SENT
BACK TO NIH AND SENT TO THE
PROGRAM STAFF AT THE
ADMINISTERING I.C.s TO REVIEW
THEM AND WORK WITH SUBMITTERS TO
REVISE THE LANGUAGE AS NEEDED
AND THEN THOSE GO BACK TO NIH
SENIOR LEADERSHIP TO MAKE THE
FINAL DECISION ON WHETHER TO
ISSUE STOP WORK ORDERS OR NOT.
>> HOW ARE THE GRANTS FLAGGED?
>> BY DOGE OF THE CONTENT WITHIN
TITLE, ABSTRACT SPECIFIC AIMS.
I'LL DOUBLE CHECK AND FOLLOW-UP
WITH OUR OER COLLEAGUES,
FEEDBACK FROM OUR OER
COLLEAGUES.
>> IS A LIST OF THE FLAG IGING
TERMS THAT CREATE THE FLAG
AVAILABLE?
>> I DO NOT BELIEVE SO BUT WE
WILL ASK THE QUESTION FROM OUR
EXTRAMURAL COLLEAGUES AND GET
THEIR FEEDBACK.
>> OKAY.
THANK YOU.
>> I THINK I HAVE THE SECOND
QUESTION I PUT IN THE CHAT TH TS
IS RELATED TO DR. MANLY'S
QUESTION BECAUSE THE NGA OR NEW
AWARDS AREN'T GOING OUT BECAUSE
OF THE PROCESS AND WHAT IS THE
IMPACT OF THESE FUNDING NOT
GOING OUT FROM THE NIH?
AND THREE CONCERNS AND WANTED TO
SEE HOW WE COULD HELP.
ONE WAS THE IMPACT ON CLINICAL
TRIAL PARTICIPANTS IF THERE'S A
CLINICAL TRIAL CLOSED BECAUSE
USUALLY CLINICAL TRIAL CLOSED
FOR DSMB REVIEW LOOKING AT THE
OUTCOME SAYING IT'S USEFUL OR
DANGEROUS AND WE NEED TO
TERMINATE THE TRIAL SO THIS IS
HIGHLY UNUSUAL IN TERMS OF OUR
ETHICAL OBLIGATIONS TO PATIENTS.
SECOND IS THE IMPACT ON TRIALS
BEING STOPPED AND INVESTIGATORS
IT'S IMPACT ON ACADEMIC
UNIVERSITIES AND WE HAVE A GREAT
CONCERN ABOUT THE BUDGETS
APPROPRIATION COMMITTEE WITH A
LARGE SURPLUS AT THE NIH BECAUSE
WE KNOW THE MAJORITY OF THE
AMERICAN PEOPLE AS WELL AS
INTRAMURAL AND EXTRAMURAL
INVESTIGATORS AND THE DIRECTOR
HAVE STATED WE WANT TO PRESERVE
THE NIH BUDGET IF WE CAN.
THE REAL MAIN QUESTION IS
BECAUSE IT SEEMS STRATEGIC THAT
TO DO WITH SCIENCE AND WHAT'S
FUNDED, IF THERE'S ANYTHING WE
CAN DO TO HELP OR UNDERSTANDING
WHY THE MONEY ISN'T GOING OUT,
IS IT ALL RELATED TO WHAT
DR. MANLY ASKED WAS THERE A
BOTTLENECK FOR APPROVED AWARDS.
>> WE ARE AWARE OF THE DELAYS IN
DISBURSEMENT OF FUNDS AND WE'RE
WORKING TO ADDRESS THESE DELAYS
AND MY UNDERSTANDING IS THERE'S
BEEN QUITE A BIT OF PROGRESS
MADE IN JUST THE LAST WEEK OR
TWO ON GETTING SOME OF THESE
GRANTS REISSUED AND GETTING SOME
PAUSES LIFTED AND GETTING FUNDS
OUT THE DOOR.
SO ONE THING I'LL NOTE ALL NOTE
CLINICAL TRIALS THAT MAY BE
AFFECTED BY THE STOP WORK ORDERS
OR AWARDS WE'RE PROVIDING FUNDS
AND ADEQUATE TIME LINES FOR SAFE
AND ORDERLY SHUT DOWNS ON THE
ORDER OF UP TO SIX MONTHS TO
MAINTAIN PARTICIPANT SAFETY AND
PRIVACY AND MAINTAIN ANIMAL
WELFARE WHERE IT'S APPLICABLE.
>> THANK YOU.
>> WITH REGARD TO THE NEW POLICY
WITH CONSIDERATION AND
SUBMISSION WITH FOREIGN
APPLICATIONS CAN YOU EXPLAIN THE
EXTENT TO WHICH OUR COUNCIL OR
PERHAPS EVEN BY EXTENSION OTHER
I.C. COUNCILS PART OF THE SECOND
LEVEL REVIEW PROCESS.
AND HOW THE FINDINGS OF THE
REVIEWS WILL BE TAKEN INTO
ACCOUNT FOR HIGHER LEVEL AWARDS
IT GOES TO THE DOGE ISSUE.
BECAUSE THE CONCERN BY THOSE WHO
HAVE SPOKEN TO ME AND ELSEWHERE
IS THE DUE PROCESS IS INTENDED
TO ELIMINATE MOST IF NOT ALL
FOREIGN AWARDS, WHICH IF THAT'S
THE CASE, IT WILL HAVE
DELETERIOUS IMPACT ON HUMAN
HEALTH RESEARCH AND CONTRIBUTE
TO WASTEFUL SPENDING ON PROJECTS
HALFWAY THERE AND THEN DROPPED
AND THAT MAKES PROCESSES MORE
INEFFICIENT AND I KNOW WE'RE ALL
WORKING TOWARDS GREATER
EFFICIENCY.
>> THANK YOU.
UNDERSTOOD AND APPRECIATE YOUR
COMMENTS.
NIH DOES REMAIN COMMITTED TO
SUPPORTING INTERNATIONAL
SCIENTIFIC COLLABORATION WITH
FOREIGN SCIENTISTS AS WELL AS
IT'S CONDUCTED IN A SECURE AND
JUSTIFIABLE AND RESPONSIBLE WAY.
THERE'S NO INTENTION TO IN ANY
WAY CEASE FUNDING OF FOREIGN
COMPONENTS THEY'RE STRUCTURED OF
INDEPENDENT SUB PROJECTS RATHER
THAN SUB AWARDS.
THAT'S THE GOAL OF ESTABLISHING
THIS NEW AWARD STRUCTURE BY THE
END OF SEPTEMBER SO THAT WE CAN
TRACK EACH OF THE PROJECT'S
FUNDS INDIVIDUALLY.
I THINK THAT'S EVERYTHING I CAN
SAY ABOUT THAT.
>> ONE LAST COMMENT KIND OF
QUESTION.
WE RECOGNIZE WE HAVE A HARD STOP
TODAY AND WONDERED IF FOR THE
COUNCIL AGENDA IN SEPTEMBER IF
WE CAN ADD SOME TIME MAYBE AT
LEAST 30 MINUTES JUST TO DISCUSS
THINGS THERE'S SO MANY NEW
PROCESSES AND PROCEDURES THAT
WOULD BE HELPFUL TO THE COUNCIL.
>> FULLY AGREE AND WE WILL ADAM
ADD AMPLE TIME IN SEPTEMBER TO
HAVE ROBUST DISCUSSION ON ALL
THESE ISSUES AND QUESTIONS.
THE LAST SET OF QUESTIONS I SEE
ON HERE IS FROM RAFA WHO I
BELIEVE HAD TO JUMP OFF AT 2:00
P.M. AND IT'S ABOUT LOOKING
AHEAD AND PLANNING AND
UNDERSTANDING HOW THE EVOLVING
FUNDING LANDSCAPE MAY AFFECT THE
RESEARCH COMMUNITY AS A WHOLE
AND CLARITY ON RESEARCH
PRIORITIES, WHICH SCIENTIFIC
AREAS THAT RECEIVED FUNDING IN
THE PAST ARE LIKELY TO BECOME
INGELABLE FOR SUPPORT AND WHICH
INSTITUTES AND CENTERS CAN
ANTICIPATE FUNDING RANGES OVER
THE COMING YEARS.
SO WHAT I WOULD SAY ABOUT THESE
IS FIRST TO ADDRESS THE CLARITY
ON RESEARCH PRIORITIES I REFER
YOU TO DR. BHATTACHARYA WHERE HE
OUTLINED WHAT HIS PRIORITIES ARE
AND REFER YOU TO THE RECENT MAHA
COMMISSION REPORT RELEASED I
THINK LAST NURSE OR THE THURSDAY
BEFORE.
TIME FLIES WHEN YOUR HAVING FUN
ADDRESSING THE CHILDHOOD CHRONIC
DISEASE CRISIS AND MANY OF THE
PRIORITIES AND SUBJECT AREAS
THAT WERE HIGHLIGHTED IN THAT
REPORT.
I WOULD DIRECT YOU TO THE
STANDARD SCIENCE AND THOSE ARE
AREAS THAT ARE PRIORITIES TO ARE
THE ADMINISTRATION AND HHS AND
NIH LEADERSHIP.
IN TERMS OF GUIDANCE THE NIH
POLICIES AROUND FUNDING ARE
CLEARLY AB ARTIC HATED IN ALL
THE NOTICE OF FUNDING
OPPORTUNITIES AND RESEARCH
OPPORTUNITY ANNOUNCEMENTS.
SO I WOULD DIRECT YOU TO THOSE
IN TERMS OF INSTITUTIONAL
GUIDANCE.
OUTCOME LEVELS IS DEPENDENT ON
THE BUDGET.
THE AMOUNT THE NIH WILL CONTINUE
TO BE THE PREMIER FUNDER OF
BIOMEDICAL RESEARCH IN THE
WORLD.
THE PRESIDENT HAS CLEARLY STATED
THAT AND THE NIH DIRECTOR AND
SECRETARY AND THE EXACT LEVEL OF
FUNDING THAT WILL BE ALLOCATED
TO SUPPORTING EXTRAMURAL
RESEARCH WILL BE DEPENDENT ON
THE NIH'S BUDGET IN THE COMING
FISCAL YEARS.
SO WITH THAT, I REALLY THANK YOU
ALL FOR YOUR THOUGHTFUL INPUT
AND DISCUSSION.
I PERSONALLY AM VERY MUCH
LOOKING FORWARD TO GETTING TO
KNOW ALL OF YOU BETTER AT THE
NEXT COUNCIL OF COUNCILS MEETING
IN PERSON IN SEPTEMBER I THINK
SEPTEMBER 11 AND 12.
WE LOOK FORWARD TO SEEING YOU IN
THE FALL AND AS I MENTIONED, WE
WILL ADDRESS THESE QUESTIONS IN
WRITING AS AN ADDENDUM TO THE
MEETING MINUTES AND MAKE SURE
THAT THAT GETS CIRCULATED AN
POSTED TO ENSURE FULL
TRANSPARENCY AND RIGOR IN
ADDRESSING THE THOUGHTFUL ISSUES
YOU'VE RAISED TODAY SO THANK YOU
ALL.
>> THANK YOU SO MUCH.
>> THANK YOU.