>> WELCOME, EVERYONE TO THE 38TH
MEETING OF THE NATIONAL CENTER
FOR ADVISING SCIENCES, ADVISORY
COUNCIL. WELCOME AND OPENING THE
MEETING AND TO DO THAT I NEED TO
GAVEL US IN TO OFFICIALLY START
THE MEETING. I HAVE THIS LITTLE
HANDY DANDY THING HERE. WE
SHALL OPEN THE SESSION. WELCOME
TO THE MEETING, EVERYONE. IT IS
NOT EASY TO DO THAT ALWAYS WHEN
YOU ARE REMOTE SO APOLOGIES FOR
THAT, WE WERE ABLE TO GET IT
DONE. BEFORE WE GET STARTED WITH
THE DIRECTOR'S REPORT I WANT TO
TAKE A MOMENT TO TURN OVER TO
DR. ANNA RAMSEY EWING WHO WILL
DO ROLL CALL FOR THE MEMBERS TO
MAKE SURE WE ARE ACCOUNTED FOR.
ANNA, OVER TO YOU.
>> THANK YOU, JONI. ALL RIGHT.
SERGIO AGUILAR GAXIOLA. ARE YOU
ON?
>> YES, I AM. THANK YOU.
>> THANK YOU. PAUL HARRIS.
>> I'M HERE.
>> THANK YOU. JONATHAN
HIMMELFARB.
>> HERE AS WEL WELL.
>> KELLY MCVEARRY. WE WILL COME
BACK TO KELLY. ROBIN MERMESTEIN.
>> HERE, THANK YOU.
>> KEITH, MUELLER.
>> HERE.
>> AND WHAT ABOUT PAULA
SHIREMAN? ALL RIGHT. KELLY
MCVEARRY, HAVE YOU JOINED?
>> YES.
>> KELLY? I BELIEVE YOU MAY BE
MUTED. I CAN SEE THAT KELLY HAS
JOINED. ALL RIGHT, JONI WILL
IRON OUT THE TECHNICAL GLITCH
WITH KELL KELLY. LET'S GO AHEAD
NEXT SLIDE PLEASE. NEXT SLIDE.
ALL RIGHT. SO WE HAVE HAD OUR
CALL TO ORDER. WE'LL HAVE A FEW
ANNOUNCEMENTS THEN ENJOY OUR
DIRECTOR'S REPORT THAT INCLUDES
THE TRIANGLE INCLUSION REPORT.
AFTER THAT WE HAVE A SHORT
SESSION WHERE WE MAY HAVE SOME
PUBLIC COMMENTS. THEN WE WILL
WRAP UP AND ADJOURN FOR THE DAY
NEXT SLIDE. EVERYONE IN THE MS
TEAMS MEETING IS ATTENDEE. TO
MAINTAIN A SMOOTH FLOW WE
REQUEST YOU WAIT UNTIL THE
PRESENTATION IS OVER THEN USE
THE RAISE HAND FEATURE AND WAIT
UNTIL CALLED UPON TO PROVIDE
INPUT. PLEASE MAKE SURE WHEN
YOU ARE SPEAKING YOUR CAMERA IS
ON SO YOU ARE SPOTLIGHT FORD THE
VIEWERS OF THE VIDEO CAST. IF
YOU ARE NOT ON CAMERA, THE
PREVIOUS SPEAKER WILL REMAIN
SPOTLIGHTED. AUDIENCE MEMBERS
YOU MAY SUBMIT COMMENTS UNTIL
MAY 1 BY USING THE EMAIL
FUNCTION ON NIH VIDEOCAST USING
THE SEND MY FEEDBACK BUTTON OR
BY SENDING AN EMAIL TO
NCATSCOUNCILINPUT@MAIL.NIH.GOV.
AS YOU CAN SEE OUR FEATURE -- I
BELIEVE SOMEONE MAY NEED TO
MUTE. OUR FUTURE MEETING DATES
IS CURRENTLY SCHEDULED. WE DO
NOT KNOW WHEN WE WILL BE HOLDING
THE MAY SESSION, FOR 2525 BUT
ANTICIPATE IT IS LIKELY JUNE OR
JULY. THE SEPTEMBER MEETING IN
2025 IS SCHEDULED FOR SEPTEMBER
18 AND 19TH. IN 2026 THE MEETING
ARE CURRENT WILL I SCHEDULED FOR
JANUARY 29 THROUGH 30TH. THAT
WILL BE A VIRTUAL MEETING. MAY
21-22ND AND SEPTEMBER 17 THROUGH
18TH. NEXT SLIDE. NOW IT IS
TIME FOR OUR REPORT TO COUNCIL
FROM OUR NCATS DIRECTOR. JONI.
>> ALL RIGHT. THANK YOU SO MUCH
ANNA FOR THOSE UPDATES. WELCOME
EVERYONE TO THE REPORT TO THE
COUNCIL FROM ME. I'M EXCITED TO
BE HERE, THIS I BELIEVE IS THE
FIRST COUNCIL OF THE SEASON FOR
SINCE WE HAVE HAD THE NEW
ADMINISTRATION. I WANT TO REMIND
YOU THIS IS NOT THE APRIL MAY
COUNCIL HEARSAY THE JANUARY
COUNCIL WE ARE WORKING ON HERE.
IT JUST HAPPENS TO BE IN APRIL.
WE HAD A FEW DELAYS EARLIER THIS
YEAR IN MOVING FORWARD ON
COUNCIL PRESENTATIONS BUT THIS
IS -- WE ARE RESUMING NOW AND
REALLY EXCITED TO BE HERE TODAY.
SO PLEASE GO TO THE NEXT SLIDE.
WE WILL GET STARTED HERE. IT HAS
BEEN A WHILE SINCE WE MET SO I
WANT TO RECAP WHAT WE HAD TALKED
ABOUT AT OUR LAST COUNCIL WHICH
WAS IN SEPTEMBER OF 2024. AT
THAT POINT IN TIME I TALKED
ABOUT THE NEW LEADERSHIP WE HAD
IN PLACE WITHIN NCATS AND WE ARE
EXCITED TO HAVE THAT LEADERSHIP
IN PLACE AS WE HAVE GONE
FORWARD. AT THE TIME WE DIDN'T
HAVE A 2025 BUDGET WE WERE STILL
MT. MIDST OF CR AND TURNS OUT WE
ARE STILL IN THE MIDST OF A CR,
A FULL YEAR CR IS WHAT OUR
BUDGET LOOKS LIKE. SO THERE
WON'T BE ANY MORE ACTIONS
RELATED TO BUDGET FOR 2025 BUT I
EXPECT WE WILL TALK ABOUT THE
2026 BUDGET IN THE COMING WEEKS
AND MONTHS. I TALKED ABOUT A FEW
CONGRESSIONAL BRIEFINGS, AND I
WILL TALK ADDITIONAL ONES DONE
SINCE THEN. ALSO AT THE LAST
COUNCIL IT WAS KIND OF A NICE
MOMENT BECAUSE IT WAS UNUSUAL
WHEN THE COUNCIL WROTE A LETTER
TO ME AND BECAUSE ANY LETTER
THAT IS WRITTEN TO ME OR TO THE
COUNCIL I NEED TO MAKE PUBLIC SO
I BRING THOSE UP IN OPEN
COUNCIL. IT WAS A MOMENT WHERE I
WAS ABLE TO TALK ABOUT LETTER
FROM OUR COUNCIL TO ME ABOUT HOW
THEY'RE ENTHUSIASTIC ABOUT
CHANGING NCATS FROM CENTER TO AN
INSTITUTE. I HOPE TO UPDATE YOU
A LITTLE BIT ON WHAT HAS
TRANSPIRED SINCE THEN BUT I
WANTED TO AGAIN THANK OUR
COUNCIL FOR THE CO-ACTIVE NATURE
AND BEING INVOLVED IN HELPING
ADVANCE TRANSLATIONAL SCIENCES.
SO I'M GOING TO GO AHEAD AND
MOVE FORWARD ON SOME OF THE
OTHER ADVANCES WE HAVE HAD OVER
THE PAST YEAR. SO MOVING TO THE
NEXT SLIDE. BEFORE I GET INTO
THE SCIENTIFIC ADVANCES I WANT
TALK ABOUT SOME OF THESE NEWS
ANNOUNCEMENT CHANGES THAT HAVE
BEEN TAKING PLACE. AS Y'ALL KNOW
PLEASE GO TO THE NEXT SLIDE,
WITH ANY NEW ADMINISTRATION
COMES NEW LEADERSHIP. AS NIH IS
IN THE DEPARTMENT OF HEALTH AND
HUMAN SERVICES OUR DHHS, ROBERT
F. KENNEDY JR. WAS SWORN IN AS
SECRETARY OF DHHS BACK IN
FEBRUARY. AND HE HAS ARTICULATED
HIS VISION FOR THE HEALTH OF THE
AMERICAN PEOPLE. SO HE'S IN
PLACE AND THAT ALLOWED US TO GO
TO THE NEXT SLIDE AND BRING ON A
NEW NIH DIRECTOR SO FOLLOWING
THE APPOINTMENT OF THE SECRETARY
WE WERE PLEASED TO WELCOME DR.
JAY BHATTACHARYA. HE IS AN
ACCOMPLISHED DOCTOR RESEARCHER
AND HEALTH ECONOMIST. HE HELD A
TENURE PROFESSORSHIP IN MEDICAL
SCHOOL AT STANFORD UNIVERSITY IN
CALIFORNIA AND DR. BHATTACHARYA
RESEARCH HAS FOCUSED ON
POPULATION AGING AND CHRONIC
DISEASE PARTICULARLY IN HEALTH
AND WELL BEING OF VULNERABLE
POPULATIONS. HE EXPECTS TO
CONTINUE SOME OF THOSE
ACTIVITIES ON THE BROADER SCALE
AT THE NIH AND I WILL TALK MORE
ABOUT HIS BROADER VISION. HE IS
ENCOURAGING DIFFERENT
PERSPECTIVES BECAUSE THAT WILL
BE CENTRAL TO HIS APPROACH IN
LEADING THE NIH, LEANING ON THE
NIH EXPERTISE AND INNOVATION AND
THE PURSUIT OF SCIENCE. SO WE
LOOK FORWARD TO HIS LEADERSHIP
AND ENSURING THE NIH FULFILLS
ITS MISSION TO HAVE ADVANCING
HEALTH AND LENGTHENING LIFE
THROUGH EXCELLENT BIOMEDICAL
RESEARCH. HE JOINED A FEW WEEKS
AGO IN THE MIDST OF QUITE SOME
DRAMATIC CHANGES THAT ARE STILL
IMPACTING THE NIH. AND I HAVE
HAD THE OPPORTUNITY TO MEET WITH
HIM AND TALK ABOUT NCATS AND I
HAVE REALLY BEEN IMPRESSED BY
HIS SCIENTIFIC CURIOSITY AND
DRIVE TO USE THAT FOR IMPACTING
OUR ABILITY TO ADVANCE OUR
UNDERSTANDING OF DISEASE. HE IS
PUBLICLY SPOKEN ABOUT HIS TOP
THREE AREAS AND SO THAT HE'S
MOST INTERESTED THAT HE WANTS TO
PUSH. SO I WANT TO TALK ABOUT
THOSE FOR JUST A SECOND. IF HE
CAN GO TO NEXT SLIDE. THESE ARE
HIS TOP THREE AREAS OF INTEREST
AND THERE ARE THREE MAIN ONES.
HE TALKS A LITTLE BIT IN MORE
DETAIL BUT I WILL JUST DESCRIBE
THESE AT A HIGH LEVEL. THE FIRST
IS TO FOCUS ON DISEASES AND
CONDITIONS THAT AFFECT PEOPLE.
THESE ARE CHRONIC BUT HE IS
CLEAR TO POINT OUT RARE DISEASE
AND UNDERSTANDING RARE DISEASE
IS IMPORTANT IN THAT
UNDERSTANDING. SO BOTH CHRONIC
AND RARE DISEASE ARE IMPORTANT.
DAY OF REPRODUCIBILITY AND
DRIVING INNOVATION. AND THE WAY
HE THINKS ABOUT THIS TOO IS THIS
IS ABOUT THESE AREAS AT THE
BASIC LEVEL, AT THE
TRANSLATIONAL LEVEL AND THE
CLINICAL LEVEL. SO IN TERMS OF
HOW NCATS IS WELL-POSITIONED IN
EACH OF THESE AREAS, FOR EXAMPLE
IN THE FIRST GOAL NCATS HAS TWO
FLAGSHIP PROGRAMS MADE REALLY
FOR STUDYING CHRONIC AND RARE
DISEASE. THE CTSAs AND RARE
DISEASE CLINICAL RESEARCH
NETWORK AND OTHER PROGRAMS LIKE
DATA TRANSLATOR AND 3C, AND OUR
DATA RESOURCES, STUDYING THESE
UNDERDOG PROTEINS THAT ARE SEEN
AS HIGH RISK BUT HAVE HIGH
POTENTIAL FOR SMALL MOLECULE
DEVELOPMENT, THESE ARE ALL AREAS
NCATS IS WORKING TOWARDS, WE ARE
ALSO WORKING TOWARDS DEVELOPING
A NEW MODEL THAT ARE MORE HUMAN
FIZZ Q2 LOGICALLY BASED TO HELP
US -- PHYSIOLOGICALLY BASED TO
HELP STUDY DISEASES. SO IN MANY
WAYS WELL-POSITIONED TO
CONTRIBUTE TO THIS PARTICULAR
GOAL. WE ARE ALSO
WELL-POSITIONED TO CONTRIBUTE TO
THE OTHERS. IN TERMS OF
REPRODUCIBILITY, THIS IS A WORD
THAT IS WOVEN INTO OUR FABRIC AT
NCATS. MANY OF OUR PROGRAMS
REQUIRE INDEPENDENT VALIDATION
AS PART OF THE AWARD WE SUPPORT,
PART OF THE AWARDS WE SUPPORT.
AND FOR EXAMPLE, OUR GENE TARGET
THERAPY WORK AS WELL AS TISSUE
CHIP PROGRAM, THESE EFFORTS ARE
ONES THAT HAVE VALIDATION
NETWORKS BUILT IN TO THE FABRIC
OF THESE PROGRAMS. OTHER THINGS
LIKE TESTING CENTERS FOR
QUALIFICATION ARE IMPORTANT FOR
NOVEL APPROACH METHODOLOGIES. SO
THESE ARE REALLY IMPORTANT. IN
ADDITION OUR NCATS LABS HAVE
SPEARHEADED SOMETHING CALLED
TRANSLATION TOGETHER WITH
REPRODUCIBILITY AS ONE AREA OF A
KEY EMPHASIS. TRANSLATION
TOGETHER IS A PROGRAM THAT WORKS
ACROSS 7 DIFFERENT COUNTRIES TO
TEST AND VALIDATE ASSAYS IN MANY
DIFFERENT LABS TO UNDERSTAND AND
WORK THROUGH THE DIFFERENCES
THAT WE SEE AS THOSE ASSAYS ARE
CONDUCTED IN DIFFERENT
LABORATORY ENVIRONMENTS. TO
UNDERSTAND WHERE VARIABILITY
COMES IN, UNDERSTAND HOW THAT
IMPACTS DATA REPRODUCIBILITY. SO
THIS IS AN IMPORTANT PROGRAM WE
HAVE BEEN PART OF AND LOOK TO
CONTINUE THAT WORK. IN ADDITION
NCATS OVERSEES THE ASSAY
GUIDANCE MANUAL. THIS IS A
PROGRAM THAT DOES WORKSHOPS,
WEBINARS, AND ACTUALLY HAS AN
ACTUAL MANUAL CALLED THE ASSAY
GUIDANCE MANUAL. THESE
DISSEMINATE BEST LABORATORY
PRACTICES. THEY DEVELOP TOOLS
FOR DATA ANALYSIS AND RIGOR AN
REPRODUCIBILITY AND PRE-CLINICAL
DRUG DISCOVERY. I WILL TALK
ABOUT ONE OF THE WORKSHOPS HELD
IN A MOMENT BUT I WANTED TO GIVE
YOU A SENSE THAT THIS
REPRODUCIBILITY COMPONENT IS KEY
FOR US AND NCATS BECAUSE IT IS
SO CRITICAL HOW WE DRIVE THE
TRANSLATIONAL CLINICAL SCIENCE
THAT FOLLOWS. THE LAST ONE
HERE, BUT NOT LEAST IS CERTAINLY
AROUND INNOVATION. HERE AGAIN
INNOVATION IS A WORD INHERENT IN
WHAT WE DO AT NCATS. TEAM
SCIENCE DRIVES INNOVATION AND
THIS IS A NATURAL FOR US. OUR
DIVISION OF CLINICAL INNOVATION,
THAT IS EVEN BUILT TO THE NAMES
OF ALL OUR DIVISIONS, THE
CTSAs ARE WITHIN THAT
DIVISION. THEY INNOVATE ON MANY
THINGS THAT ARE CLINICALLY
RELEVANT. INCLUDING HAVING
CLINICAL TRIAL NETWORK AND
SPEARHEADING NATIONAL CLINICAL
COHORT COLLABORATIVE OR NC 3
CLINICAL WHICH IS AN ENCLAVE OF
ELECTRONIC HEALTH RECORDS AND
REAL WORLD DATA. OUR DIVISION OF
THE RARE DISEASE RESEARCH
INNOVATION, THAT WORK AGAIN, IT
PROVIDED LEADERSHIP TO INNOVATE
RARE DISEASE AND INCLUDING
CLINICAL TRIALS, BIOMARKER
DEVELOPMENT. THIS IS THE
CRITICAL BECAUSE NUMBER OF
PATIENTS WITH A GIVEN RARE
DISEASE ARE SMALL, RARE. AND SO
INNOVATING ON HOW TO STUDY
CLINICAL TRIALS AN RESEARCH IN
SMALL POPULATION, IS A CHALLENGE
SO WE APPROACH RARE DISEASE IN
MORE THAN ONE DISEASE AT A TIME
MANNER TO THINK REALLY IN WAYS
THAT ARE SYSTEMS GENERATING.
BIOLOGICAL SYSTEMS GENERATED.
BUILDING PLATFORM BASED
APPROACHES FOR PRECISION
MEDICINE ESPECIALLY GENE TARGET
THERAPIES, ET CETERA. FINALLY
OUR DIVISION OF PRE-CLINICAL
INNOVATION, THIS IS -- THESE ARE
NCATS LABS AND IT IS TEAMING AN
ENVIRONMENT OF INNOVATION. IT IS
VERY SUCCESSFUL IN CONTRIBUTING
TO NEW DRUG APPROVALS, USING
DATA SCIENCE, LEADING IN AREAS
SUCH AS AI, FOR DRUG
DEVELOPMENT, HIGH THROUGH PUT
SCREENING AND ASSAY DEVELOPMENT
ARE ALL CRITICAL THINGS THAT
DRIVE RESULTS THAT REDUCE
BARRIERS IN TRANSLATIONAL
SCIENCE SO WE CAN PIVOT TO ANY
DISEASE OR PROJECT THAT IS
NEEDED FOR US TO HELP OUT AND
MOVE FORWARD IN. SO NCATS IS
REALLY GROUNDED IN EACH OF THESE
AREAS AND WE ARE EXCITED TO WORK
WITH DR. BHATTACHARYA IN MOVING
THIS VISION FORWARD AND
CONTINUING REALLY THE WORK WE
HAVE BEEN DOING FOR A WHILE,
PERHAPS ADDING TO THAT IN MORE
INNOVATIVE CREATIVE WAYS. ON
THE NEXT SLIDE, I WILL SAY TOO
AS WE HAVE NEW LEADERSHIP COMING
IN WE HAVE ALSO BEEN IN THE
MIDST OF ALIGNING WITH HHS AND
NIH PRIORITIES THAT HAVE BEEN
SET FORTH WITHIN THE TRANSITION
OF THE NEW ADMINISTRATION. SO
THERE'S LOTS OF CHANGES BEING
MADE, AT GOVERNMENT LEVEL, AS
WELL AS AT THE NIH LEVEL. MANY
OF THESE CHANGES ARE STILL
UNDERWAY AS WE WORK TO IMPLEMENT
THEM AND WITH THAT I WOULD SAY
WE MAY NOT KNOW THE ANSWERS YET
TO HOW WE WILL MOVE FORWARD ON
ALL ASPECTS BUT WE DO HAVE -- WE
ARE STARTING TO GET MORE CLARITY
IN TERMS OF THINGS LIKE SOME OF
THESE FEATURES THAT THESE
CHANGES HAVE CONTRIBUTED TO. FOR
EXAMPLE WE ARE CENTRALIZING OUR
PEER REVIEW PROCESS AT THE NIH.
ONE OF THE REASONS WE ARE DOING
THAT IS SO WE CAN STRENGTHEN OUR
CONFLICT OF INTEREST SAFEGUARDS
THERE'S BEEN A PERCEPTION THAT
HAVING THE APPLICATIONS THAT
COME INTO AN IC AND HAVING IC
REVIEW THEM MIGHT CREATE SOME
CONFLICT. REST ASSURED WE HAVE
MANAGED THAT CONFLICT VERY WELL.
AND ARE VERY CAREFUL ABOUT THAT
HOWEVER THERE IS A PERCEPTION.
CENTRALIZING PEER REVIEW IS A
REASONABLE RESPONSE TO THAT AND
THAT IS ONE WAY WE ARE GOING TO
-- SYSTEM OF THESE CHANGES ARE
AFFECTING THE ALIGNMENT TO THESE
PRIORITIES. I WILL SAY TOO IT IS
IMPORTANT FOR US TO CONSIDER
THAT, A LOT OF THESE CHANGES ARE
CREATING WAYS WE MIGHT DO
BUSINESS DIFFERENTLY BUT I'M
HOPING IT WILL BE A SEAMLESS
TRANSITION FOR THE COMMUNITIES
PERSPECTIVE IN TERMS OF THAT
PEER REVIEW EXPERIENCE. BECAUSE
IN MANY WAYS A LOT OF STAFF THAT
WILL BE CONDUCTING THAT PEER
REVIEW WHO HAVE BEEN IN ICs
BEFORE WILL BE TRANSITIONING TO
THEIR MORE CENTRALIZED ROLE
WITHIN CSR TO CONTINUE
CONDUCTING THOSE REVIEWS. AGAIN,
THE IDEA WOULD BE THAT THIS
WOULD BE A SEAMLESS TRANSITION
AND I THINK THAT'S -- THAT WILL
HOPEFULLY WORK VERY WELL. OTHER
CHANGES THAT YOU HAVE
EXPERIENCED IS WE HAVE HAD A
PAUSE ON FACA MEETINGS. REVIEW
AND COUNSEL MEETINGS BUT AS
EVIDENCE TODAY WE ARE HAVING THE
FIRST COUNCIL MEETING OF THE
SEASON AND SO THESE FACA
MEETINGS ARE RESUMING NOW. IN
FACT OVER THE PAST COUPLE OF
WEEKS WE HAVE SEEN MORE REVIEW
MEETINGS HAPPEN IN CSR SO THINGS
ARE STARTING TO RESUME AND THAT
IS REALLY A GOOD THING. ONE
THING YOU PROBABLY NOTICED IN
YOUR WORDS OR IN PARTICULAR
FUNDING OPPORTUNITIES THERE HAVE
BEEN CHANGES TO HOW WE LOOK AT
AWARDS AND MAKING SURE WE ARE
ALIGNING WITH THE HHS AND NIH
PRIORITIES WITHIN THOSE AWARDS.
SO THERE MAY BE CHANGES IN
COMPETING APPLICATIONS OR
NON-COMPETING RENEWALS THAT YOU
MAY EXPERIENCE. THAT IS ALL JUST
TO MAKE SURE WE ARE ALIGNING
WITH HHS AND NIH PRIORITIES. YOU
WILL ALSO SEE IF YOU LOOK AT A
PARTICULAR NOTICE OF FUNDING
OPPORTUNITY, ALL OF THESE HAVE
ALSO BEEN ADJUSTED TO REFLECT
THE HHS AND NIH PRIORITIES. SO
THEY HAVE BEEN ESSENTIALLY
REVISED WHERE THEY NEEDED TO BE
REVISED AND REPOSTED SO ALL
NCATS NOFOs HAVE GONE LIEU
THIS PROCESS. SO EVERYTHING
SHOULD BE UP TO DATE THERE. I
WANT TO JUST STOP HERE AND JUST
SAY A FEW OTHER THINGS TO
HIGHLIGHT UNDER THE AWARDS
CATEGORY. IN TERMS OF THE
APPLICATIONS AND CERTAINLY FOR
FOLKS WHO ARE LISTENING IN,
ACCEPTING APPLICATIONS FOR
ACTIVE FUNDING OPPORTUNITIES,
SOME OF THOSE OPPORTUNITIES MAY
HAVE BEEN CLOSED DEPENDING ON
WHAT THEY WERE -- WHAT THEY WERE
FOCUSING ON AND OTHERS AS I
MENTIONED HAVE BEEN UPDATED TO
ALIGN WITH THESE AGENCY
PRIORITIES. SO I REALLY WANT TO
MAKE SURE APPLICANTS OUT THERE
ARE CONSIDERING THESE CHANGES
CAREFULLY REREADING AND
REVIEWING THOSE FUNDING
OPPORTUNITIES FOR ANY CHANGES
PRIOR TO SUBMISSION OF YOUR
APPLICATION. SO THAT IS A REALLY
IMPORTANT THING THAT I WANT TO
RELAY TODAY. THE OTHER THING YOU
MIGHT SEE IS THAT PLANS FOR
ENHANCING DIVERSE PERSPECTIVES
OR PEDP ASPECT OF GRANTS OR
CONFERENCE GRANT DIVERSITY PLANS
OR EQUIPMENT PLANS TO ENHANCE
DIVERSITY ALL HAVE BEEN ADJUSTED
AND ARE NO LONGER BEING REQUIRED
OR EVALUATED BUT RATHER THESE
CONDITION THINGS THAT ARE
MENTIONED IN THE GRANT IN A MORE
GENERAL WAY TO RELAY IMPORTANT
SCIENTIFIC STUDIES THAT ARE
BEING CONDUCTED TO LOOK AT
DIFFERENT POPULATIONS. JUST A
NOTE ON AWARDS THEMSELVES,
ISSUING AWARDS FOR COMPETING
NON-COMPETING CONTINUATION AND
ADMINISTRATIVE SUPPLEMENTS USING
PREVIOUSLY APPROVED NEGOTIATED
AND DIRECT COST RATES, ACCEPT
FOR AWARDS UNDER WHICH THE
INDIRECT COSTS ARE REIMBURSED AT
A FIXED RATE ARE -- THAT IS
ANOTHER ISSUE THAT HAS BEEN
HIGHLIGHTED ON OUR GRANTS PAGE.
SO THESE QR CODES AT THE BOTTOM,
ONE IS A FOCUS ON GRANTS AN
FUNDING INFORMATION STATUS.
THESE ARE LATEST CHANGES
IMPACTING NIH GRANTS
ADMINISTRATION AND FUNDING, A
LOT OF THE POINTS I MENTIONED
ARE POLLED FROM THAT PARTICULAR
WEBSITE SO ALL THAT IS PUBLICLY
AVAILABLE THAT YOU CAN LOOK AT
AND SEE. THE ONE QR CODE ON THE
RIGHT, THE ONE IN BLACK IS
INFORMATION ON NIH TERMINATED
GRANTS. SO YOU CAN ACCESS THE
GRANTS THAT HAVE BEEN TERMINATED
HERE AS WELL. THERE IS AN
ACCOMPANYING PDF THAT DESCRIBES
THOSE TWO. SO I WANT TO MAKE
SURE THOSE ARE PUBLICLY
AVAILABLE RESOURCES FOR YOU IF
YOU ARE INTERESTED OR AFFECTED
BY ANY OF THESE ACTIVITIES.
PLEASE GO TO THE NEXT -- I GUESS
ONE MORE THING I WOULD SAY HERE.
GO BACK ONE, APOLOGIES. THE
ONLY OTHER THING I WOULD SAY
ABOUT THIS SLIDE IS THAT I DON'T
KNOW IF YOU CAN GO BACK ONE.
THANK YOU. ARE THERE HAS BEEN A
PROCESS WITHIN FEDERAL
GOVERNMENT BROADLY BUT ALSO
WITHIN NIH AND WE EXPERIENCED
THOSE IN FORCE REDUCTIONS. OUR
STAFF IS REDUCED. ALSO THROUGH A
SERIES OF CONSOLIDATIONS IN
PARTICULAR AREAS OF ACTIVITY
LIKE I MENTIONED IN TERMS OF
CENTRALIZING PEER REVIEW,
CONSOLIDATING MORE CENTRALLY
MORE CONSOLIDATIONS TAKE PLACE
IN OTHER AREAS THAT ARE COMMON.
THIS IS ONGOING IN FEDERAL SPACE
BUT I WANT TO TAKE A MOMENT TO
RECOGNIZE REDUCTIONS IN FORCE
AND OTHER CHANGES WE HAVE
EXPERIENCED SO THAT YOU ARE
AWARE OF WHAT'S HAPPENING. ALL
NCATS ARE EDITING TO -- SUBMIT
YOUR GRANT APPLICATION TO MAKE
SURE YOU ARE FOLLOWING THE
INSTRUCTIONS WITHIN THE FORMATS
THE NEXT SLIDE, JUST IN TERMS OF
REDUCTIONS IN FORCE. I WANT THE
TAKE A MOMENT NCATS HAS HAD 36
STAFF DEPART THROUGH VARIOUS
MEANS DURING THIS TIME. ALL THE
STAFF LOSSES ARE HAVE BEEN
DIFFICULT. EACH PERSON PLAYED A
KEY ROLE ADVANCING THE SCIENCE
AND OPERATION OF NCATS AND I
WOULD BE REMISTO RECOGNIZE AT
LEAST TO NOT RECOGNIZE THOSE
INCREDIBLE LEADERS T N CATS AND
ACROSS THE NIH SO I WANT TO TAKE
A MOMENT TO RECOGNIZE THE
LEADERS AT NCATS WHO HAVE
DEPARTED THEIR LEADERSHIP ROLES
HERE. JUST SAY HOW IMPORTANT
THEY HAVE BEEN TO WHAT WE DO AT
NCATS. WE WILL CONTINUE TO
CONDUCT A LOT OF THE ACTIVITIES
THEY HAVE SUPPORTED BUT THEY
WILL BE SORELY MISSED. TALK A
MOMENT TO RECOGNIZE THEM. ON THE
NEXT SLIDE, GIVEN THE LOGISTICAL
AND ONGOING CHANGES, THE LAST
DAY OF FEBRUARY, IT IS A RARE
DAY IN FEBRUARY BECAUSE
SOMETIMES A DITCH DAY WE HAD A
MAKE THE DIFFICULT DECISION TO
CANCEL PLANNED JOINT FDA AND NIH
RARE DISEASE DAY. IT IS
IMPORTANT TO KNOW FOR EVERYONE
THAT WHILE THE EVENT WILL NOT
TAKE PLACE THIS YEAR, OUR
DEDICATION TO RARE DISEASE
COMMUNITY HAS NOT CHANGED. NIH
AND THE FDA REMAIN FIRMLY
COMMITTED TO ACCELERATING THE
DEVELOPMENT OF TREATMENTS AND
CURES AND TO OFFERING RESOURCES
THAT PROVIDE HOPE AND SUPPORT TO
MILLIONS ACROSS THE COUNTRY
AFFECTED BY RARE DISEASE. THOUGH
NOT ABLE TO HOST RARE DISEASE
DAY THIS YEAR, WE WERE STILL
ABLE TO LIGHT UP THE NIGHT AT
BUILDING ONE ON THE NIH MAIN
CAMPUS. AND DOMINIQUE
(INDISCERNIBLE) DIRECTOR OF RARE
DISEASE DIVISION AT NCATS AND I
WERE ABLE TO BE THERE AND TAKE
PICTURE ON THAT NIGHT AND JOHN
BURKELOE CHIEF OF STAFF WHO IS
ALSO RETIRENING A FEW DAYS IS --
RETIRING IN A FEW DAYS SO WANT
TO ACKNOWLEDGE FOLKS THAT
CELEBRATE RARE DISEASE DAY AND
ACKNOWLEDGE WE WILL HOPEFULLY
GET BACK ON -- WHEN WE RESUME
THOSE ACTIVITIES. THIS IS A
SLIDE ON THE BUDGET AS STANDS.
AS YOU KNOW WE ARE CURRENTLY IN
FULL YEAR CONTINUING RESOLUTION
SO BUDGETS LOOKS THE SAME AS
LAST YEAR AS FULL YEAR
CONTINUING RESOLUTION DOES AND
WE DO NOT YET KNOW THE UPSHOT OF
FY 2026 BUDGET. WE WILL TALK
ABOUT THAT AT THE NEXT COUNCIL.
THE PRESIDENT'S BUDGET WILL BE
THE FIRST THING THAT KEEPS UP
THAT PROCESS. JUST WANT TO GIVE
YOU A SENSE OF THE BUDGET AT
$928 MILLION FOR FY 25 TO
CONTINUE THOSE ACTIVITIES. IF
YOU WOULD LIKE TO LEARN MORE
LOOK AT QR CODE TO UNDERSTAND
HOW THE BUDGET BREAKDOWNS
ACTUALLY UNROLE. THE NEXT SLIDE,
I MENTION THE IMPACTS OF THE
STAFF REDUCTIONS IN THE PEOPLE
WHO WERE AFFECTED BY THAT BUT
ALSO I WANT TO HIGHLIGHT KEEFE
STAFF ADDITIONS OVER THIS TIME
TOO. WE ARE VERY EXCITED TO HAVE
THESE FOLKS ON OUR LEADERSHIP
TEAM AND HOPE YOU WILL BE ABLE
TO INTERACT WITH THEM AT THE
NEXT IN PERSON COUNCIL MEETING
SO TAKE A MOMENT TO HIGHLIGHT
THESE FOLKS. SOME OF WHOM YOU
PROBABLY KNOW FROM BEFORE BUT
BECAUSE I THINK THEY WERE ON THE
CUSP IN SEPTEMBER OF COMING ON
BOARD BUT I WANT TO HIGHLIGHT
THEM AGAIN FOR THIS COUNCIL. SO
WE ARE HAPPY TO HAVE THESE FOLKS
IN LEADERSHIP POSITIONS TO HELP
US MOVE FORWARD. NEXT SLIDE I
WANT TO GET INTO SOME OF THE
ACTIVITIES THAT WE HAVE BEEN
DOING SINCE WE LAST MET. ONE OF
THOSE THINGS, I WAS ABLE TO
ATTEND THE 13TH ANNUAL HOOP ON
THE HILL MEETING THROUGH CURE
SMA. SO I WANT TA TAKE A MOMENT
TO THANK CURE SMA FOR THAT
INVITATION TO GIVE A KEYNOTE AT
THEIR HOPE ON THE HILL EVENT.
SMA IS A DEVASTATING RARE
DISEASE BUT THIS GROUP HAS COME
TOGETHER AT INCREDIBLE FASHION
TO ADVANCE ALREADY THREE
APPROVED THERAPEUTICS AND THEY
HAVE APPROVED OTHERS ON THE
PIPELINE ON THE WAY. AS RARE
DISEASE GOES THAT'S ALSO QUITE
RARE TO HAVE THREE APPROVED
DISEASES THAT CAN HELP THIS
PARTICULAR DISEASE. IT WAS
ENERGIZING, INSPIRING, TO BE
WITH THEM TO UNDERSTAND WHAT
MAKES THEIR SORT OF SECRET SAUCE
AND HOW THEY DO THEIR WOR WORK.I
WAS TRYING TO GET A SENSE WHAT
THAT WAS WHEN I WAS THERE. ONE
ASPECT IS THAT THEY HAVE A
TRANSLATIONAL SCIENCE ADVISORY
COUNCIL AS PARTS OF THE CURE SMA
BOARD. I THINK ONE OF THE KEY
FEATURES OF THIS IS THEY REALLY
HAVE THAT FOCUS OF TRANSLATIONAL
SCIENCE. SO PERHAPS THIS MIGHT
BE SOMETHING OTHER GROUPS COULD
CONSIDER AS BEST PRACTICE TO
HAVE GROUP OF PEOPLE THINKING
ABOUT TRANSLATIONAL IMPACTS AND
TRANSLATIONAL SCIENCE FOR THE
PARTICULAR DISEASES THEY ARE
WORKING THROUGH. THERE ARE
PROBABLY MANY OTHER THINGS IN
TERMS OF SECRET SAUCE THAT CURE
SMA HAS, HOPEFULLY THAT WILL BE
INTERACTIONS YOU CAN HAVE WITH
THEM TO LEARN FROM THEM AS WELL,
I HAD A GREAT OPPORTUNITY TO
LEARN FROM THEM AND IT WAS A
FANTASTIC EXPERIENCE SO I WOULD
LIKE TO THANK THEM FOR THAT
INVITATION. THE NEXT SLIDE IS
ABOUT AN OPPORTUNITY I WAS
INVITED TO SPEAK ON HILL ABOUT
THE NATIONAL CLINICAL COHORT
COLLABORATIVE OR NC 3 CLINICAL,
AS WELL AS BROADER ARTIFICIAL
INTELLIGENCE AI INITIATIVES WE
SUPPORT AT NCATS. IT IS ALWAYS
GOOD WHEN CONGRESS SHOWS
INTEREST IN THE WORK THAT YOU
ARE DOING AND INVITES YOU TO
COME TALK TO THEM ABOUT WHAT YOU
ARE DOING. BUT I CAN SAY IT
WASN'T REALLY ME WHO MAKES THAT
HAPPEN, THE PEOPLE IN THE
BACKGROUND OF THIS SLIDE WHO ARE
THE ONES WHETHER REALLY MAKE THE
CONVERSATIONS SING. THEY ARE THE
EXPERTS IN THIS SPACE AND REALLY
DID A GREAT JOB TALKING TO
SENATOR MARK HEINRICH STAFFER
AND SENATOR MIC ROUNDS. SO WE
HAD BOTH SIDES REPRESENTED AND
IT WAS GREAT TO TALK HOW WE WERE
THINKING SPEEDING INNOVATION
THROUGH N 3C SO I WANT TO
RECOGNIZE THE GROUP FOR DOING
THAT BUT ALSO RELAY THAT WE ARE
ALSO ACTIVELY PURSUING THESE
SORTS OF ENGAGEMENTS EFFORTS ON
THE HILL TOO. THE NEXT SLIDE IS
IS ONE OTHER ACTIVITY WE
RECENTLY HAD THROUGH OUR DPI
RESEARCH DAY. WE HAVE AN
INCREDIBLY TALENTED TRAINING
DIRECTOR IN BRAIN EARLY SHE
OVERSEES MANY TALENTED NCATS
TRAINEES AND POST DOCS AND WE
ARE ABLE TO CELEBRATE A LOT OF
WORK THEY HAVE BEEN DOING
THROUGH POSTER SESSIONS AND
SHORT TALKS. AT THE END OF THE
DAY WE HAD A MOMENT TO CELEBRATE
THE WORK THEY HAVE BEEN DOING
AND RAISE A TOAST TO EACH OTHER
FOR ALL THOSE ACTIVITIES. THEY
ARE REALLY LIFE BLOOD OF WHAT WE
DO AT NCATS IN YOUR TRAINING
PROGRAMS AND IN OUR INTRAMURAL
PROGRAMS TOO. SO I WANT TO
RECOGNIZE THAT. IN TERMS OF ALSO
WHILE ON THE TOPIC OF INTRAMURAL
PROGRAMS, GO TO NEXT SLIDE, I
MENTIONED THE REPRODUCIBILITY
ASPECT AND WHY THAT IS SO
IMPORTANT TO NCATS. ON THE THE
NEXT SLIDE I SHOW THERE IS
SOMETHING CALLED ASSAY GUIDANCE
MANUAL. THIS ASSAY GUIDANCE
MANUAL KNOWN AS AGM FOR SHORT,
THIS IS REALLY A WORLD-CLASS
SOURCE OF GUIDELINES AND BEST
PRACTICES FOR DANCING
TRANSLATION -- ADVANCING
TRANSLATIONAL SCIENCES AN
RESEARCHING THE PRE-CLINICAL
DEVELOPMENT SPACE OFFERS
TRAINING AND INSIGHT FOR THOSE
WHO WANT TO BECOME TRANSLATIONAL
SCIENTISTS. THIS IS REALLY ABOUT
COMMUNITY DEVELOP LABORATORY
PRACTICES IN THAT EARLY
TRANSLATIONAL RESEARCH PHASE,
THINGS LIKE ROBUST ASSAY
DEVELOPMENT ANALYTICAL
TECHNOLOGIES, DATA ANALYSIS
TOOLS, PRE-CLINICAL DRUG
DISCOVERY STANDARDS, ALL THOSE
ASPECTS ARE AREAS WHICH THE
ASSAY GUIDANCE MANUAL COVERS AND
WE HAVE WEBINARS AND WORKSHOPS
SELECT SPECIFIC PROGRAMS TO TALK
ABOUT THAT ARE TIMELY AND
RELEVANT FOR MOVING FORWARD. ONE
REASON WE HAVE HERE IN SILICO
DRUG DISCOVERY WORKSHOP TALKING
ARTIFICIAL INTELLIGENCE AND
MACHINE LEARNING, BECAUSE IT IS
QUITE A PIVOTAL ROLE IN
ACCELERATING DRUG DISCOVERY AND
HOW WE THINK ABOUT TRANSLATIONAL
SCIENCE. OUR NCATS TEAMS ARE
APPLYING AI TO ENHANCE HIGH
THROUGH PUT SCREENING BY
DETECTING ASSAY ARTIFACTS AND
OPTIMIZING COMPOUND PROPERTIES
LIKE METABOLIC STABILITY,
ABSORPTION, FOR DISEASES LIKE OR
AND TOXICITY. THESE ARE METHODS
THAT ARE IMPORTANT FOR HELPING
STUDY THINGS LIKE CANCER, RARE
DISEASE INFECTIOUS DISEASE AND
ALSO ADVANCING THE NEXT
GENERATION OF MODALITIES, THAT
ARE GOING TO BE IMPORTANT FOR
DEVELOPING THESE SORTS OF
THERAPEUTICS. THINGS LIKE
MOLECULAR GLUES, PROTAX OR THE
PROTEOLYSIS TARGETING CHIMERAS,
TARGET ANTIBODIES OR FANTASTIC
BODIES AN GENE TARGETED THERAPY.
THERE IS A VARIETY OF THINGS IN
THE ASSAY GUIDANCE MANUALNA ARE
REALLY IMPORTANT. -- MANUAL THAT
ARE REALLY IMPORTANT. FOR THIS
PARTICULAR MEETING WE WERE
THRILLED TO HAVE DAVID BAKER
JOIN US AND AS YOU KNOW HE WAS
AWARDED THE 2024 NOBEL PRIZE IN
CHEMISTRY FOR HIS
GROUND-BREAKING WORK IN
COMPUTATIONAL PROTEIN DESIGN,
ALONG WITH DENISE (INAUDIBLE)
AND JOHN JUMPER FOR PROTEIN
STRUCTURE PREDICTION AND THIS
FIELD IS FUNDAMENTALLY RESHAPING
OUR UNDERSTANDING OF BIOLOGY AND
OPENING NEW DOORS FOR
THERAPEUTIC DEVELOPMENT SO AN
EXCITING MEETING. I HAVE PUT THE
QR CODES HERE IN CASE YOU ARE
INTERESTED IN HEARING THESE
TALK. THE KEYNOTE ADDRESS BY
MARTI HEAD IS DAY 1 AND DAVID
BAKERS TALK ON DAY 2 SO I
ENCOURAGE YOU TO LOOK AT THAT.
THIS ALLOWED US TO HAVE DEEP
DISCUSSIONS THAT WILL DIRECTLY
SHAPE HOW QUICKLY AND HOW
EFFECTIVELY NEW TREATMENTS CAN
REACH PATIENTS AND ULTIMATELY
SAVE LIVES SO THIS AGAIN IS
QUINT ESSENTIALLY WHAT WE DO AT
NCATS AND THIS WAS A FANTASTIC
MEETING I WANTED TO HIGHLIGHT
FOR YOU TODAY. GO ON THE NEXT
SLIDE, ONE MORE FEATURE I WANTED
TO TALK ABOUT THAT'S HAPPENED IN
THE LAST FEW MONTHS SINCE WE
LAST MET IS THAT OUR COUNCIL IS
VERY FAMILIAR WITH SUCCESS OF
OUR INTRAMURAL LABS NCATS LABS
OR DIVISION OF PRE-CLINICAL
INNOVATION BUT I WANT TO SHOW
YOU THE RECORD OF CLINICAL
SUCCESS THAT IT HAS HAD. OVER
OUR 13 YEAR HISTORY, MUCH LIKE
THE CLINICAL CENTER IS AMERICA'S
HOSPITAL, NCATS HOUSES THE
PRE-CLINICAL LABS THAT CONDUCTS
COLLABORATIVE PRE-CLINICAL
RESEARCH PROJECTS FOR CHRONIC
AND RARE DISEASES DEVELOPING NEW
METHODS AND TECHNOLOGIES THAT
SPEED TRANSLATION AND ADVANCE
THEM TO THE CLINIC. SO WE LIKE
TO THINK FOR OURSELVES AS THE
PRE-CLINICAL CENTER. TO DATE WE
HAVE CONTRIBUTED TO OVER 56
INVESTIGATIONAL NEW DRUGS THAT
WE CAN POINT TO AND KNOW ABOUT.
AND THEN FOUR OF ACTUALLY IN
ADDITION THERE ARE FOUR OF THESE
THAT HAVE NEW DRUG APPROVAL.
OVER 56 I IND APPLICATIONS TO NW
DRUG MODULES. LIKE GENE THERAPY.
THE ONE HERE ON UP STAZA, THE
FIRST GENETHERRY DELIVERED
DIRECTLY TO THE BRAIN TO HELP
CHILDREN WITH AADC DEFICIENCY.
THIS WAS COLLABORATION WITH
INTERNATIONAL GROUP IN TAIWAN
AND IT WAS APPROVED BY E MA A
FEW YEARS AGO AND MORE RECENTLY
APPROVED BY THE FDA. WE ARE
REALLY EXCITED TO SEE THAT. SO
THIS IS ONE OF THOSE AREAS THAT
WE HAVE DEVELOPED A WEBSITE NOW
TO SHOW THIS. IF YOU CLICK
THROUGH THE NEXT SLIDE I WANT TO
GIVE YOU A SENSE WHAT YOU CAN
FIND ON THIS WEBSITE BECAUSE I
THINK IT IS CRITICAL TO HAVE
THIS INFORMATION AVAILABLE. SO
OUR WEBSITE SHOWS THESE
INFORMATION ABOUT THESE 60
INDs AND NDAs. IF YOU GO TO
NEXT SLIDE HAND CLICK THROUGH
EACH OF THESE INDs OR NDAs
HAS A SPECIFIC CARD ON OUR
WEBSITE AND YOU CAN CLICK ON THE
APPROVED OR THE IND FOR THAT
PARTICULAR CARD. IF YOU WERE TO
CLICK ON UPSTAZA, GO TO THE NEXT
SLIDE, WITHIN THOSE CARDS IT
WILL THEN IF YOU CLICK ON IT IT
WILL POP OUT TO EVEN MORE
INFORMATION ABOUT THE NCATS
CONTRIBUTIONS TO DEVELOPMENT OF
THIS THERAPEUTIC OR IND AND MORE
ABOUT THE DISEASE ITS MEANT FOR
AND ITS INDICATION. SO IT IS A
REALLY NICE CATALOG OF THESE. I
THINK A REALLY NICE WAY OF
CAPTURING COMMUNICATING NCATS
SUCCESS IN THESE ACTIVITIES. SO
YOU CAN GO TO NEXT SLIDE I ALSO
WANTED TO PICK UP ON WHERE WE
LEFT OFF THE LAST COUNCIL. IN
WORKING WITH ALL OF OUR
DIFFERENT DIVISIONS AND OFFICES
WE FINISHED THE NCATS STRATEGIC
PLAN AND MADE A FEW TWEAKS TO
THE PLAN TO ENSURE WE ARE
THINKING ABOUT THE HHS AND NIH
PRIORITIES WITHIN THAT. WE HELD
ALSO INTERNAL IMPLEMENTATION
CONFERENCE. YOU ARE SEEING THE
BEHIND THE SCENES PICTURES OF
ALL THE STAFF AT NCATS WHO ARE
CRITICAL IN HELPING SHAPE THE
IMPLEMENTATION OF STRATEGIC
PLAN. AND HOW WE ARE THINKING OF
MOVING FORWARD TOGETHER IN A
UNIFIED COORDINATED FASHION. WE
ARE CONTINUING WORK IN THAT
STRATEGIC PLAN SPACE MOVING FROM
STRATEGIC PLANNING TO STRATEGIC
DOING. NOTHING IS MORE EXCITING
THAN BEING ABLE TO MOVE FORWARD
IN THAT WAY. THE NEXT SLIDE I
WANT TO GIVE YOU THE TIME LINE
IN TERMS OF WHAT'S NEXT. YOU
EXPERIENCED WITH ME AS PART OF
THE COUNCIL OUR PLANNING PROCESS
THAT WEPT THROUGH THIS STRATEGIC
PLAN AND NOW WE HAVE AN INTERNAL
IMPLEMENTATION TEAM LED BY ANIKA
WAYMAN DEPUTY DIRECTOR AND WE
WILL CONTINUE TO DEVELOP THAT
AND WORK THROUGH IMPLEMENTATION
THROUGH INITIATIVES AND OTHER
PROGRAMS AND PROJECTS THAT NCATS
WILL PURSUE. STAY TUNED ON THAT.
THE NEXT SLIDE, ONE OF THE
THINGS I WANT TO BRING UP,
SOMETHING HAPPENED I THINK IN
THE DISPLAY HERE BUT IT LOOKS
LIKE SOME OF THE WORDS CROSSED
EACH OTHER. HOPEFULLY YOU CAN
SEE OKAY ON YOUR SIDE. ONE THING
I WANT TO BRING UP, THERE ARE
SOME BARRIERS TO ACCELERATING
OUR STRATEGIC PLAN ONE BARRIER
IS AROUND THE IDEA NCATS IS
PROHIBITED FROM CONDUCTING PHASE
3 CLINICAL TRIALS. THIS IS A
LONG STANDING PROHIBITION SINCE
INCEPTION OF NCATS WE HAVE THE
WORLD'S LEADING NATIONAL
CLINICAL TRANSLATIONAL SCIENCE
AWARDS PROGRAM WITH THAT, SINCE
WE ARE PROHINTED FROM DOING
PHASE 3 CLINICAL TRIALS, IT
LEADS TO THIS IDEA WE MAY BE
UNDERUTILIZING CTSA PROGRAM.
THAT SAID, CTSA INSTITUTIONS ARE
STILL LEADERS IN THIS SPACE.
THEY CAN CONTINUE TO DO PHASE 3
COST JUST NCATS IS ABLE TO
SUPPORT THOSE. IF THEY ARE
SUPPORTED FROM ANOTHER CENTER,
THEY CAN PROCEED WITH THAT AND
THEY BRING THAT LEADERSHIP IN
CLINICAL REESSENTIAL AND
CLINICAL TRIALS TO TABLE AND
THAT VALUABLE. IF WE THINK ABOUT
THIS IN MORE TRANSLATIONAL
SCIENCE LEVEL OF ACTIVITY,
HAVING THIS WAYS IN WHICH WE CAN
THINK ABOUT REOF MOVING THIS AS
PROHIBITION IS CRITICAL FOR
ABILITY TO EVEN NAVIGATE OUR
ABILITY TO INNOVATE AROUND
CLINICAL TRIALS MORE. AND
WORKING TOGETHER WITH ALL OF OUR
PROGRAMS TO BE ABLE TO DO THAT.
SO H IS ONE OF THOSE AREAS THAT
I WANT TO MAKE SURE COUNCIL IS
AWARE OF, AND UNDERSTAND TOO WE
ARE WORKING THROUGH AND CAN
NAVIGATE THIS PROCESS VERY WELL
FOR EXAMPLE IN SOME WAYS WHEN WE
WERE WORKING IN THE COVID SPACE
A LOT OF PHASE 3 CLINICAL TRIALS
WERE SUPPORTED BY OPERATION WARP
SPEED OR BARTA OR OTHER SPACES
SO IT WASN'T NCATS DOLLARS THAT
SUPPORTED BUT ABLE TO BRING
CTSAs TO THE TABLE TO ADVANCE
THOSE TRIALS. SO WE DO PLAY A
DEEP ROLE IN THIS BUT THIS IS
ONE OF THOSE AREAS THAT CAN BE
VERY HELPFUL. NEXT SLIDE. I
MENTIONED TRADING EARLIER AND
HOW IMPORTANT THAT WAS
ESPECIALLY WITH THE INTRAMURAL
PROGRAM BUT I WANT TO FOCUS ON
THE EXTRAMURAL PROGRAM AND
LARGELY THROUGH CTSA SAFETY
GROUPS THIS IS A PAPER BY BOB
AND HIS GROUP TALKING ICORR.
THAT'S A SHORT COURSE THAT
TRANSLATIONAL AND CLINICAL SANS
SCIENCES TO ASSESS REAL WORLD
IMPACT OF RESEARCH THROUGH
CUSTOMER DISCOVERY, ABOUT WHAT
THE NEEDS ARE AND ADVANCING THE
SCIENCE H. NSF I-CORPS. THE NSF
HAS A PROGRAM SIMILAR TO THIS
THAT IS SUCCESSFUL SO WE HAVE
ADOPTED IT. SO WHAT THIS GROUP
DID IS EVALUATE THE
BUILDS SKILLS LIKE SYSTEMS
THINKING, COMMUNITY AND TEAM
SCIENCE AND COLLABORATION. WHAT
THIS GROUP ALSO SHOWED IS NOT
ONLY DOES IT DO THAT,
INTERESTINGLY PARTICIPANTS WHO
WENT THROUGH THIS PROGRAM
SURFACE QUALITIES LIKE
INTELLECTUAL HUMILITY, COGNITIVE
FLEXIBILITY AND THAT REMINDS US
THAT TRANSLATIONAL SCIENCE IS AS
MUCH ABOUT HOW WE THINK ABOUT
THE SCIENCE OPPOSED TO WHAT WE
DO IN THAT SCIENCE. I THOUGHT
THAT WAS A SALIENT THOUGHT
AROUND THIS PARTICULAR PAPER SO
I WANTED TO BRING IT TO YOUR
ATTENTION. NEXT SLIDE IS ANOTHER
SLIDE THAT TALKS TRAINING
PROGRAMS WE HAVE WITHIN THE CTSA
PROGRAM, THIS ONE IS ABOUT
CAREER DEVELOPMENT ANDCATION
SCHOLARS SO MORE EARLY CAREER
TYPES OF INVESTIGATORS. ANALYSIS
CONDUCTED HERE AT NCATS WITHIN
THE CTSA OFFICE IS WE LOOKED AT
HOW OUR CTSA SCHOLARS COMPARED
TO OTHER SCHOLARS ACROSS THE
NIH. SO THE NCATS SCHOLARS ARE
SHOWN IN A TALE COLOR AND THE
OTHER SCHOLARS ARE SHOWN IN A
GREEN COLOR. WE FOUND A HIGHER
PERCENTAGE OF NCATS SUPPORTED
SCHOLARS THAT APPLY FOR AND
RECEIVE AWARDS AFTER THEIR K
TRAINING COMPARED TO OTHER NIH
SUPPORTED SCHOLARS. OTHER NIH
SUPPORTED SCHOLARS HAVE HIGHER
PERCENTAGES OF SCHOLARS WHO
DON'T GO ON TO APPLY FOR
SUBSEQUENT FUNDING FROM NIH BUT
MAY GO ON TO OTHER AREAS. AND
GET THAT FUNDING. SO THAT MAY BE
RATIONALE FOR WHY WE SEE THIS
BUT I THINK IT IS ALSO THE FACT
THAT WE HAVE A ROBUST CAREER
DEVELOPMENT PROGRAM WITHIN THE
CTSA PROGRAM THAT IS AVAILABLE.
SO I WANT TO HIGHLIGHT THAT AND
COMMEND CTSA K DIRECTORS ON THE
WORK THEY ARE DO IN THAT SPACE.
THE NEXT SLIDE IS ONE OTHER
ADVERTISEMENT IF YOU WILL. VERY
RECENTLY AFTER A PERIOD OF VERY
LONG AND VERY EXCELLENT DETAILED
WORK IS ABOUT RELEASE OF
PRINCIPLES OF COMMUNITY
ENGAGEMENT, THIS IS THE THIRD
EDITION OF THIS PIECE AND IT IS
A PRACTICAL GUIDE FOR COMMUNITY
ENGAGEMENT THAT'S WRITTEN BY THE
COMMUNITY OVER A 165 RENOWN
PRACTITIONERS AROUND THE
COUNTRY. ONE OF OUR COUNCIL
MEMBERS HAS BEEN ACTIVE AND
LEADING A LOT OF EFFORT SO I
WOULD LIKE TO THANK SERGIO FOR
HIS ROLE IN THIS AS WELL. SO H
IS JUST ANOTHER THING THAT I
THINK IS REALLY WHAT NCATS --
WHY NCATS REMAINS IMPORTANT TO
THE WORK WE DO IN CLINICAL AND
TRANSLATIONAL SCIENCE. NEXT
SLIDE IS JUST UPDATE ON WHAT WE
HAVE BEEN DOING IN THE NATIONAL
CLINICAL COHORT COLLABORATIVE OR
NC 3. WE HAD A LONG STANDING
ENCLAVE IN THIS SPACE AROUND
COVID AND LONG COVID AND WE ARE
PARTICULARLY NOW SHIFTING TO THE
LONG COVID SPACE. BUT WE ARE
ALSO RECOGNIZING THE IMPORTANCE
AND VALUE OF REAL WORLD DATA AND
ELECTRONIC HEALTH RECORD
INFORMATION SO WE HAVE CONDUCTED
A SERIES OF PILOTS, USING OUR
ENCLAVE INFRASTRUCTURE TO
DEVELOP OTHER AREAS THAT WE CAN
PURSUE IN THE RESEARCH SPACE SO
WE HAVE A KIDNEY DISEASE ENCLAVE
AND CANCER ENCLAVE PILOT AS
WELL. BUT A KEY FEATURE IS
THERE IS A COMMON INFRASTRUCTURE
WITH THIS ENCLAVE. ON LEFT-HAND
SIDE OF THAT COMMON
INFRASTRUCTURE IS THAT THE WORK
WITHIN THE ENCLAVE CAN HAVE
ACCESS TO MANY OTHER TYPES OF
GOVERNANCE STRUCTURE, HELPING
DATA CLEAN, DATA QUALITY, HOW WE
DO DEIDENTIFICATION. AND AI AND
TOOL BASED ENVIRONMENT.
SO THAT COMMON INFRASTRUCTURE IS
APPLIED TO ANY GIVEN ENCLAVE
WITHIN OUR CLINICAL NEW
STRUCTURE. ANOTHER FEATURE ON
RIGHT HANDED SIDE ARE THE
RESEARCH DATA SETS. WE HAVE
BEEN ABLE TO BRING RESEARCH DATA
SETS THAT EXIST ELSEWHERE BUT WE
BROUGHT THEM TO MAKE THE WHOLE
OF THE RESEARCH DATA SETS
GREATER THAN THE SUM OF THE
PARTS. THE STRUCTURE OF THIS
ALLOWS US TO LEVERAGE THOSE
COMMON BITS OF INFRASTRUCTURE
THROUGH THE DATA SETS OR THE
GOVERNANCE OR WHATEVER THAT
MIGHT LOOK LIKE, KEEPS
SUSTAINABLE FOR MANY RESEARCH
QUESTIONS AND NEEDS. SO WE
DON'T HAVE TO RECREATE THE WHEEL
EACH TIME. INSTEAD WE THINK EACH
PARTICULAR RESEARCH QUESTION WE
ARE INTERESTED IN. SO I WANT TO
GIVE YOU A SENSE WHERE WE ARE
GOING NEXT WITH OUR ELECTRONIC
HEALTH RECORD DATABASE THROUGH
NC 3 CLINICAL. I ALSO WANTED TO
HIGHLIGHT THE REAL SUCCESS OF
WHAT'S HAPPENED IN THE COVID
SPACE FROM THE LAST FIVE YEARS
OF THIS WORK. REALLY INCREDIBLE
PRODUCTIVITY IN THIS TYPE OF
CLINICAL DATA RESEARCH THAT HAS
HELPED US THINK ABOUT THIS MORE
DEEPLY AND RECOGNIZE WE NEED TO
DO MORE OF THIS IN OTHER
DISEASES. WHAT WAS DONE IN COVID
IS LIKE A PROOF OF PRINCIPLE
THAT THIS NEEDS TO BE APPLIED
MORE BROADLY. SO I WANT TO GIVE
YOU A SENSE OF THE OTHER
ACTIVITIES THAT HAVE GONE ON IN
TERMS OF NOT JUST THE
PUBLICATIONS BUT COLLABORATION
INCENTIVE IT PROVIDES, THE
INFORMATION USED TO CHANGE
GUIDELINES AND HOW -- AND CARE.
EVIDENCE-BASED DEFINITIONS OF
PARTICULAR DISEASES LIKE LONG
COVID AND DEVELOPING NEW MODELS
FOR HOW THESE ARE STUDIED. SO H
IS REALLY A -- I THINK AGAIN
PROOF OF PRINCIPLE HOW IMPORTANT
THIS WORK IS FOR OTHER DISEASES
AS WELL. THE NEXT SLIDE I JUST
TALK ABOUT WHAT'S NEXT FOR NC 3
CLINICAL. BASICALLY WHAT IS NEXT
IS WE WANT TO CONTINUE TO
DEVELOP THESE PILOTS AND
HOPEFULLY EXPAND THEM INTO THESE
OTHER AREAS. WE ARE WORKING
THROUGH THE OPERATIONAL
APPROACHES AND THE GOVERNANCE
STRUCTURE AN TECHNICAL
ARCHITECTURE THAT IS NEEDED TO
DO THAT. SO WE ARE CONTINUING TO
HAVE EVERYTHING AVAILABLE TO THE
RESEARCH COMMUNITY BUT ALSO
USING THIS PILOT PHASE FOR THOSE
OTHER AREAS OF RESEARCH
QUESTIONS WE WOULD LIKE TO
PURSUE STUDY. ONE MORE THING I
WANT TO MENTION IN TERMS OF
ACTIVITIES THAT NCATS --
ACTUALLY TWO THINGS, IN TERMS OF
NCATS WHAT NCATS IS DOING IN
PURSUING. ONE IS IN THE NEXT
SLIDE OF QUANTUM SENSING AND
QUANTUM COMPUTING. AND APOLOGIES
FOR THESE SLIDES BEING A LITTLE
BIT CHANGED IN HOW THEY WERE
BROUGHT INTO THE FRAMEWORK BUT
HOPEFULLY YOU CAN SEE THIS
RELATIVELY WELL. WE HAVE
LAUNCHED A PRIZE CHALLENGE OR
PRICE COMPETITION TO CATALYZE
APPLICATIONS OF QUANTUM
COMPUTING AND QUANTUM SENSING
THROUGH A VARIETY OF
MULTI-DISCIPLINARY EFFORTS SO
THE PRIZE IS PARTICULARLY MEANT
TO DERISK THIS AS AN AREA OF
SCIENCE FOR HOW WE WANT TO BRING
IN MORE BIOMEDICAL RESEARCH
QUESTIONS. IN QUANTUM COMPUTING
AND SENSING. THESE TWO
ACTIVITIES ARE AROUNDLY FOR
QUANTUM COMPUTING AROUND DRUG
DISCOVERY, DEVELOPING MACHINE
ALGORITHMS AND QUANTUM SENSING
HOW WE APPLY THOSE APPROACHES TO
ADVANCING BIOMEDICAL
APPLICATIONS. THINKING ABOUT
NOVEL APPROACH METHODOLOGIES AND
EMBEDDING SENSORS OR DIAGNOSTICS
SO THERE IS GREAT ACTIVITY GOING
ON IN THIS SPACE AND WE ARE
EXCITED THAT THIS IS MOVING
FORWARD TOWARDS THE REVIEW STAGE
RELATIVELY SOON. IN FACT MAY
THROUGH JULY WILL BE THAT STAGE
1 WHEN WE'LL SEE THAT. WITH THIS
TOO THERE IS A SHARED INTEREST
ACROSS THE NIH PARTNERING WITH
OTHER INSTITUTES AND CENTERS.
EVERYTHING IS A TEAM WITH US SO
WE DO THAT IN IWAY BUT WE ARE
EXCITED TO HAVE THE NATIONAL EYE
INSTITUTE, ENGINEERING INSTITUTE
AND IDIB ENGINEERING AND IMAGING
DATA SCIENCE AND THE CENTER FOR
IT AS WELL. I WILL ALSO
RECOGNIZE (INDISCERNIBLE),
DEPUTY DIRECTORRER OF OFFICE OF
SPECIAL INITIATIVES IN DAN
TAGLY'S GROUP AND SHE SPEARHEAD
THIRD DEGREE ENTIRE EFFORT NOT
JUST AT NCATS BUT ACROSS THE
ENTIRE NIH SO GRATEFUL FOR HER
LEADERSHIP THERE. ONE OTHER AREA
WE HAVE LAUNCHED IS ALSO ONE
THAT'S QUITE EXCITING BECAUSE IT
IS THROUGH THE COMMON FUND
VENTURE PROGRAM. I BROUGHT IT UP
AT THE LAST COUNCIL MEETING SO I
WON'T SPEND MUCH TIME ON THIS
BUT THE NEWBORN SCREENING
THROUGH WHOLE GENOME SEQUENCING
COLLABORATORY HAS NOW LAUNCHED.
THERE ARE ANNOUNCEMENTS ON THE
STREET AND WE ARE LOOKING TO
HAVE A BUDGET OF 4.8 MILLION
TOTAL COST PER YEAR FOR ONE
MERITORIOUS TRANSACTION AWARD
THAT WILL BE A THREE YEAR
PROJECT. WE HOPE THAT WILL
DEMONSTRATE THE FEASIBILITY OF
ADDING WHOLE GENOME SEQUENCING
TO AN EXISTING PUBLIC HEALTH
RESOURCE. PERHAPS STARTING WITH
5 AND 10 SATE WITH DIFFERENT
LEVELS EXPERIENCE WITH NIH
FUNDED RESEARCH OR WHOLE GENOME
SEQUENCING AND THEN CONDUCT
THESE IN AN EMBEDDED RESEARCH
STUDY AND GENERATE A FINAL
REPORT OF HOW THAT FEASIBILITY
IS GOING SO WE CAN THINK ABOUT
USING THIS AS THE VENTURE
INITIATIVE AND EXPAND THIS INTO
A BROADER INITIATIVE. HOPEFULLY
WE WILL BE SUCCESSFUL IN DOING
THIS BUT I WANT TO RELAY TO YOU
THIS IS NOW LAUNCHED. THE NEXT
SLIDE THESE THE STRUCTURE OF THE
PROGRAM AND THE FOLKS WHO ARE
CRITICAL AND THE SUCCESS. THIS
IS PARTNERSHIP WITH NHGRI WITH
NICHD AND WITH NCATS. THESE ARE
LEADER SHOWN HERE WHO ARE
DRIVING THIS PARTICULAR
INITIATIVE. NOW, THIS NEXT
SECTION IS, THAT SECTION
CONCLUDES THE DIRECTOR'S REPORT
PER SE. NOW WE WANT TO SPEND
ABOUT TEN MINUTES OR SO ON
ANOTHER SECTION I AM PRESENTING
TODAY AS, THIS IS SORT OF A
MANDATORY REQUIREMENT THE IC
DIRECTOR PRESENT THIS
INFORMATION TO OUR COUNCIL. H IS
THE NCATS TRIENNIAL REPORT TO
MONITORING ADHERENCE TO NIH
POLICY ON INCLUSION OF WOMEN AN
MINMINORITIES IN CLINICAL RESEA.
WE DO IT EVERYONE THREE YEARS, I
WANT TO THANK MUNZIBA KHAN AS
WELL AS JOSH TO PRESENT IT TO
YOU TODAY. SO THE NEXT SLIDE IS
JUST REALLY SHOWING THAT THIS IS
MANDATED BY THE PUBLIC HEALTH
SERVICE ACT SECTION 492B, 42
UNITED STATES CODE SECTION 289A
2 THAT ENSURING THE INCLUSION OF
WOMEN AND MEMBERS OF RACIAL
ETHNIC MINORITY GROUPS IN ALL
NIH FUNDED CLINICAL RESEARCH IN
A MANNER THAT IS APPROPRIATE TO
TTOSCIENTIFIC QUESTION UNDER ST.
THE OER AT THE HIPPOREQUIRES
CERTIFICATION BY THE IC
DIRECTORS FOR THIS. AND WE
CERTIFY THE DATA ARE ACCEPTABLE
FOR INCLUSION IN THIS REPORT.
AND THAT THE DATA REFLECT THE
INFORMATION COLLECTED AS OF THE
DATE THE REPORT WAS RUN AND ONE
THING I WILL NOTE HERE IS THAT
WE ARE UNABLE TO GO BACK AND
CHANGE THINGS WITHIN THE REPORT
IF THEY EXIST IS WE CAN'T GO
BACK AND CORRECT MISTAKES BUT WE
CAN MAKE SURE THOSE MISTAKES ARE
I CAN PED UP IN ANY DATA THAT IS
MOVING FORWARD. SOMETIMES WE DO
FIND THOSE MISTAKES AND THEY
MAKE A BIG DIFFERENCE IN THE
TABLES. SO IT IS VERY DIFFICULT
TO EXPLAIN THAT WE CAN'T CHANGE
THAT BUT WE DO USE IT TO MAKE
SURE WE DON'T MAKE THOSE SAME
MISTAKES MOVING FORWARD. I ALSO
WANT TO SAY HERE THAT THE
MAJORITY OF NCATS SUPPORTED
CLINICAL RESEARCH TAKES THE FORM
OF FORMAL PARTNERSHIPS WITH
OTHER NIH INSTITUTES AND
CENTERS. TO AVOID DUPLICATION OF
REPORTING THE PARTNERING IC WE
WORK WITH NOT NCATS, REPORTS THE
INCLUSION ENROLLMENT DATA SO
MIGHT THINK THE NUMBERS ARE
FAIRLY LOW FOR NCATS. IF U YOU
I THIS IT IS LARGELY BECAUSE
THOSE NUMBERS ARE REPORTED WITH
PARTNERING ICs DOING CLINICAL
TRIALS AS WELL. SO NCATS
NUMBERS ARE A LITTLE MODEST. BUT
EXAMPLES OF NIH AND NCATS
PROGRAMS FOR WHICH OTHER ICs
REPORT ENROLLMENT DATA
ESSENTIALLY ON OUR BEHALF ARE
THINGS LIKE THE HEAL PROGRAM OR
HELPING END ADDICTION LONG TERM,
THE NETWORK AND OTHER PARTNERS
AND RARE DISEASE CLINICAL
RESEARCH NETWORK SUPPORTED BY
OTHER ICs AS WELL THAT TAKE ON
THAT RESPONSIBILITY. EXAMPLES OF
NCATS PROGRAMS FOR WHICH OUR
ENROLLMENT DATA ARE REPORTED ARE
THINGS LIKE OUR COLLABORATIVE
INNOVATION AWARDS THROUGH THE
CTSA PROGRAM OR OUR SMALL
BUSINESS AWARDS OR CTSA PILOT
STUDIES. SO THAT'S -- THOSE ARE
THE KINDS OF NUMBERS YOU WILL
SEE REFLECTED IN THE TABLES THAT
I'M ABOUT TO SHOW YOU. AGAIN,
THIS IS A REQUIREMENT FOR US TO
SHARE WITH YOU THESE PARTICULAR
DATA. YOU CAN SEE BROADER
NUMBERS HERE 22-24 COVERING
THREE YEARS, THESE ARE HUMAN
SUBJECTS AWARDS BY FISCAL YEAR.
SO THE NUMBER OF AWARDS IN 2022
WERE MUCH HIGHER THAN THEY ARE
IN 2024, LIKELY BECAUSE OF THE
NUMBER OF CLINICAL TRIALS
CONDUCTED DURING THE PANDEMIC. I
THINK THAT ACCOUNTS FOR A LOT OF
THIS DISCREPANCY ACROSS. SO THIS
WILL START TO PROBABLY LEVEL OUT
IN THE NEXT SERIES OF INCLUSION
REPORT IN THREE YEARS. THE NEXT
SLIDE AGAIN MAKES THIS CASE
ABOUT THE FADES 3 LIMITATION
NCATS CAN SUPPORT PHASE 3
CLINICAL TRIALS WITH RARE
EXCEPTIONS FOR THOSE. YOU WILL
SEE IN THE INCLUSION AND DATA
RECORD HERE, THIS IS ABOUT PHASE
3 TRIALS. YOU WILL SEE A 1 HERE.
THAT 1 IS REFLECTIVE OF OUR ROLE
IN THE COVID-19 PANDEMIC THROUGH
ACTIVE PROGRAM. WE WERE MANAGERS
OF ACTIVE 6. THIS IS ONE OF THE
THOSE CLINICAL TRIALS WE FUND
THROUGH THE ACTIVE PROGRAM. SO
IT WAS NOT NCATS DOLLARS THAT
SUPPORTED THIS, THIS WAS THROUGH
THE ACTIV PROGRAM, THAT IS WHY
IT IS REPPED HERE ON OUR BEHALF.
-- REPRESENTED HERE ON OUR
BEHALF. THAT'S WHAT THAT NUMBER
MEANS, NEXT SLIDE WE LOOK AT THE
BREAK DOWN. THIS IS -- YOU DON'T
HAVE TO LOOK AT THIS SLIDE, I
WILL BREAK IT DOWN FOR YOU, BUT
THIS IS TOTAL SLIDE WE HAVE IN
TERMS OF THE SEX BY RACE
ETHNICITY FOR EACH OF THESE
YEARS IN THE NIH DEFINED
CLINICAL RESEARCH AREAS. IF YOU
GO TO THE NEXT SLIDE WE BREAK IT
DOWN SO SALIENT POINTS ARE HERE.
LOOK ACROSS THE DIFFERENT YEARS
BROKEN DOWN BY FEMALE, MALE AND
UNKNOWN, AND MINORITY STATUS OF
THESE AS REPORTED, THE PERCENT
OF MINORITY ENROLLEES REMAIN
CONSTANT FOR FEMALES AN MALES IN
22 AND 23, HOVER WE NOTICED
INCREASE IN FEMALE MINORITY
PARTICIPANTS IN 2024. SO THAT IS
ONE OF THOSE THINGS WE FOUND. ON
THE NEXT SLIDE AGAIN BROKEN DOWN
BY SEX RACEETH IN IS THE I A
CROSS THESE YEARS. ONE
PARTICULAR AREA WE SAW THAT
STUCK OUT WAS PERCENTAGE OF
HISPANIC LATINO ENROLLEES THAT
DECREASED DRAMATICALLY MANY 2023
BUT REMAINED CLOSE TO 40% FEMALE
ENROLLEES IN 2022 AND 2024. SO
THIS IS ONE AREA THAT HELPS US
WANT TO UNDERSTAND MORE ABOUT
WHY THAT IS. AND MAKE SURE WE
ARE ADDRESSING THIS MOVING
FORWARD. THAT IS ONE WAY WE
EVALUATE THESE DATA. SO GO TO
NEXT SLIDE, THOSE ARE THE UPSHOT
OF THIS PARTICULAR INCLUSION
REPORT FOR THIS TRIENNIAL DATA
ANALYSIS. THERE ARE THREE TAKE
AWAYS FOR US. ONE TO CONTINUE
TO GROW AND ENHANCE THE NCATS
COMMUNITY OF PRACTICE OF
INCLUSION AND MONITORING
ACTIVITIES BECAUSE AS WE LOOK AT
THESE DATA WE CAN MAKE
ADJUSTMENTS MOVING FORWARD. WE
WANT TO HIGHLIGHT AND SUPPORT
THE ROLE OF THE INCLUSION OF THE
BROAD RANGE OF PARTICIPANTS IN
RESEARCH AND THIS IS SOMETHING
THAT WE HAVE HIGHLIGHTED IN OUR
STREAK PLAN AND ITS
IMPLEMENTATION AND THAT IS
SOMETHING WE ARE VERY PASSIONATE
ABOUT AS WELL. THIRDLY WE WANT
TO AMPLIFY OUR EXISTING AND NEW
TRAINING OPPORTUNITIES FOR
ENSURING WE DESIGN TRIALS
AFFECTIVELY FOR INCLUSION
POLICIES AND PRACTICES. DESIGN
MEANS REALLY THINKING ABOUT THIS
IN ALL AREAS FROM SHORT TERM
STUDIES OR PILOTS ALL THE WAY
THROUGH REALLY BIG CLINICAL
TRIALS. SO THINKING HOW WE
INCORPORATE THAT THINKING IN THE
BEGINNING WE WANT TO DRIVE THAT
MORE TO ENHANCE THE RESULTS AS
WE MOVE FORWARD AND MAKE THE
TRIALS AS ROBUST AND RESULTS
DRIVEN AS POSSIBLE TO HELP
CHANGE AND IMPACT POPULATIONS
THAT ARE AFFECTED BY DISEASE.
THOSE ARE THE THREE TAKE AWAYS
FROM OUR TRIENNIAL REPORT. WHAT
I WILL ASK YOU IS ESSENTIALLY I
WILL CERTIFY THIS REPORT AND
JUST WANT TO MAKE SURE YOU ARE
AWARE OF THIS REPORT. IF YOU
HAVE ANY INPUT I WOULD LIKE THE
ASK YOU TO JUST HAVE -- IF YOU
HAVE ANY IDEAS HOW WE CAN
PERHAPS DO THIS BETTER WE WOULD
LOVE TO HEAR YOUR THOUGHTSES AND
YOUR INPUT ON THAT. THAT WILL
HELP US MOVE FORWARD. I THINK I
JUST HAVE ONE MORE POINT TO
RELAY. THIS IS ALSO PICKING UP
FROM OUR LAST COUNCIL MEETING.
GO TO THE NEXT SLIDE. WE -- WHAT
WE DO TYPICALLY IS IF ANYONE
WRITES A LETTER TO OUR COUNCIL
OR TO ME PERMLY, AND TO ME
PERSONALLY THAT ASKS ME RELATE
TO OUR COUNCIL THIS IS MY
OPPORTUNITY TO DO THAT IN OPEN
SESSION. WE RECEIVED A LETTER
FROM THE PHYSICIAN COMMUNITY,
PHYSICIAN COMMITTEE FOR
RESPONSIBLE MEDICINE. I WANT TO
THANK HEM FOR THEIR INPUT, WE
CAN MAKE THIS AVAILABLE UPON
REQUEST. BUT IT LARGELY TALKS
ABOUT THE ENTHUSIASTIC SUPPORT
FOR ELEVATING NCATS FROM A
CENTER TO AN INSTITUTE. THIS WAS
SOMETHING THAT CAME UP AT THE
LAST COUNCIL MEETING AND IF YOU
GO TO NEXT SLIDE I WANTED TO
THANK -- UPDATE YOU ON THIS
PROCESS. BECAUSE LAST MEET THE
COUNCIL MEMBERS PRESENTED ME
WITH A LETTER. ALSO IN SUPPORT
OF TRANSITIONING FROM CENTER TO
AN INSTITUTE. THERE IS A PROCESS
WITHIN THE GOVERNMENT WE USE TO
DO THIS, THE A 19 PROCESS. THAT
IS SOMETHING WE ARE CONSIDERING
PURSUING, IT REQUIRES HHS AND
OMB APPROVAL. FOR A VARY OF
REASONS THIS IS ON HOLD AT THIS
TIME BUT I WANT TO LET YOU KNOW
WE ARE STILL THINKING ABOUT THIS
PROCESS AND HOPE TO PURSUE IT AT
SOME STAGE. IN THE MEANTIME ALSO
GAVE ME AN OPPORTUNITY TO THANK
PHYSICIANS COMMITTEE FOR THEIR
RESPONSIBLE MEDICINE AS WELL.
WITH THAT, I THINK I WANT TO GO
TO NEXT -- THE LAST SLIDE HERE
WHICH IS SUMMARY OF THE
PRESENTATION AND I WON'T GO
THROUGH IT BUT GIVES ME AN
OPPORTUNITY TO LEAVE IT ON THE
SCREEN HERE AN OPEN IT UP FOR
ANY QUESTIONS. I WILL SAY MAYBE
WE CAN DO IT IN ORDER. LET'S DO
TRIENNIAL REPORT, I LOVE YOUR
COMMENTS ON THAT SO WE CAN MAKE
SURE WE CERTIFY THAT
APPROPRIATELY AND WE WILL OPEN
UP FOR BROADER QUESTIONS
THEREAFTER. ANY COMMENTS ON THAT
TRIENNIAL REPORT? IF NONE IS THE
ANSWER THAT'S FINE TOO.
HOPEFULLY, PLEASE GO AHEAD
>> THANK YOU SO MUCH FOR JOINING
FOR THIS REALLY GOOD OVERVIEW OF
THE ACTIVITIES I GREATLY
APPRECIATE IT. IN TERMS OF THE
TRIENNIAL REPORT ONE HIGHLIGHT
FOR ME IS WHEN YOU PRESENT IT IN
TERMS OF TRAINEES CERTAINLY
LATINOS FROM 2022 TO 2024, THAT
IS A VERY STRONG EXAMPLE OF WHY
IT IS CRITICALLY IMPORTANT TO
CONTINUE TO HAVE A FINGER ON
THAT PULSE. TO COLLECT DATA
USING RACE AND ETHNICITY. I WANT
TO THANK YOU FOR BRINGING THAT
TO OUR ATTENTION AND ALSO SO
EMPHASIZE.
>> THANK YOU SO MUCH. SUPPORT OF
THAT.
>> FANTASTIC. THANK Y THANK YOUL
CONTINUE TO DO THIS, IT IS A
MANDATED ACTIVITY. I REALLY
APPRECIATE THAT, IT IS GOOD TO
SEE WE ARE BRINGING IN A VARIETY
OF POPULATIONS AND REPRESENTING
DIFFERENT RACIAL ETHNIC GROUPS
AND I AGREE IT IS GOOD TO SEE
THOSE TRENDS. THANK YOU. ANY
OTHER QUESTIONS OR COMMENTS
ONNA? PERHAPS HEARING NONE I'M
HAPPY TO JUST OPEN THIS UP TO
ANY OTHER QUESTIONS OR COMMENTS
YOU MIGHT HAVE.
>> YES. PAUL.
>> THANK YOU FOR THAT
PRESENTATION. THINKING ABOUT NC
3 AND KNOWING (INDISCERNIBLE)
RETIRED AND NOW SAM AND JOSH
HAVE LEFT WHO IS LEADING N 3C?
WHAT SORT OF SUCCESSION PLAN
THERE LOOK LIKE?
>> GREAT QUESTION. SO PAUL YOU
BROKE UP A LITTLE BIT THERE BUT
I THINK I GOT YOUR QUESTION.
YES. SO MANY PEOPLE HAVE BEEN
FOUNDATIONAL TO N 3C AND HAVE
BEEN REALLY THE FACE OF IT.
THERE HAS BEEN A SORT OF LIKE AN
ICEBERG, YOU HAVE SEEN THE
ICEBERG BUT UNDERNEATH THE WATER
THERE IS A WHOLE BUNCH OF PEOPLE
WHO SUPPORT THE WORK THAT GOES
ON. SO WE HAVE THE LUXURY AND OF
-- AND REALLY THE TALENT TO
SUPPORT CONTINUING THOSE
ACTIVITIES. SO WE ARE ABLE TO BE
VERY SEAMLESS IN MOVING FORWARD
WITH THE CHANGES IN THOSE
LEADERSHIP POSITIONS. WE HAVE
ACTING CIO WHO HAS BEEN CRITICAL
WORKING WITH OTHER COLLABORATORS
AND STAFF WITHIN NCATS, NATHAN
(INDISCERNIBLE) EXPERT BUILDING
THE ARCHITECTURE,
(INDISCERNIBLE) WHO IS REALLY N
3C, HE IS N 3C, REALLY THE GURU
BEHIND A LOT OF WORK THAT IS
THAT MAKES N 3C GO. HE'S
THINKING THROUGH THE NEW
DIRECTIONS AND GOVERNANCE
MODELING AND OPERATIONAL
APPROACHES AS WELL AS WE MOVE
INTO THE NEXT PHASE OF MORE
TENANT ENCLAVE MODEL DEVELOPMENT
AND HE IS REALLY THOUGHT THROUGH
THAT. IN TERMS OF HEEDER SHIP WE
HAVE A VARIETY OF LEADER TOO. WE
HAVE MIKE CIRILLA, CTSA AND
DIVISION OF CLINICAL INNOVATIONS
DIRECTOR. HE OVERSEES A LOT OF
THESE ACTIVITIES BECAUSE HE IS
SUPPORTED OUT OF THE CTSA
PROGRAM LARGELY HE IS CONTINUING
TO ACHE THAT RESPONSIBILITY AS
WELL AS OUR FOLKS IN HIS SHOP.
WE HAVE PERSON REALLY FOCUSED ON
POLICY DEVELOPMENTS TOO AND
WORKING ACROSS THE NIH. WE HAVE
A LEADER IN CHRIS DILLON
THINKING ABOUT OUR AGREEMENTS
THAT WE USE WITHIN THESE
ACTIVITIES. SO THERE IS NOT
REALLY I WOULD SAY ONE PERSON,
IT IS REALLY A GROUP OF
LEADERSHIP THAT COMES TOGETHER
THAT IS REALLY MANAGING HOW WE
MOVE FORWARD. AND IT'S AN
INCREDIBLE GROUP TO BE PART OF.
>> THANK YOU.
>> I SHOULD ALSO SAY SAM AND
JOSH AND KEN, THEY REALLY HAVE
BEEN THE DREAM TEAM TO GET THAT
STARTED. NOW WE HAVE DREAM TEAM
TO TAKE US TO THE NEXT PHASE SO
THE BEST OF ALL WORLDS THAT HAVE
HAPPENED AROUND HERE.
>> THANKS.
>> JONATHAN? I THINK SERGIO'S
HAND WAS UP BEFORE. THAT'S
RIGHT?
>> NO ACTUALLY IT WAS -- YES. I
WILL FOLLOW HIM.
>> JONATHAN.
>> JONI, THIS IS MY FIRST NCATS
COUNCIL MEETING, IT IS A
PLEASURE.
>> WELCOME.
>> TO BE ON THE COUNCIL AND IT
WAS JUST SO REFLESHING HONESTLY
TO HEAR HOW NIMBLE AND AGILE
NCATS IS REALLY SUPPORTING
CUTTING EDGE TECHNOLOGY AND
ENABLING INNOVATION ACROSS THE
NIH, IT IS NOT JUST WITHIN NCATS
BUT SUPPORTING INNOVATION ACROSS
THE ENTIRE NIH THROUGH THE
CTSAs BUT THROUGH ALL THE
OTHER INITIATIVES AS WELL. SO IT
IS REALLY GREAT TO HEAR. YOUR
POINT ABOUT THE PHASE 3 TRIALS,
YOU HAVE THE CTSAs IF EVER
THERE WAS A GOOD VEHICLE FOR
SUPPORTING PHASE 3 TRIALS YOU
WOULD THINK COMBINING THE KINDS
OF INNOVATION TAKING PLACE
INSIDE NCATS WITH WHAT THE
CTSAs COULD DO TO IMPLEMENT
THOSE TRIALS, I WOULD IT WOULD
SEEM IF THERE IS A WAY FOR NCATS
TO BECOME MORE LEADER IN
IMPLEMENTING PHASE 3 CLINICAL
TRIALS, THAT THAT WOULD BE
BENEFICIAL I THINK ACROSS THE
ENTIRE NIH.
>> AGREE. THANK YOU FOR THAT
COMMENT, JONATHAN. WELCOME
ABOARD. I COULDN'T AGREE MORE.
IT STRIKES ME GIVEN THE CHANGES
IN THE MODALITIES THAT ARE BEING
DEVELOPED NOW, THESE TYPES OF
GENE EDITING TECHNOLOGIES, GENE
THERAPY PROTAX ANTIBODY
DEVELOPMENT, ALL THESE THINGS
ARE GOING TO REQUIRE KIND OF A
DIFFERENT WAY OF THINKING ABOUT
CLINICAL TRIALS TOO. AND IN
ADDITION THINKING ABOUT THE
DIFFERENT DISEASES THAT ARE IN
CHRONIC FORM AFFECTING DIFFERENT
PEOPLE WHO ALSO HAVE OTHER
CHRONIC DISEASES THAT ARE IN THE
BACKGROUND, THOSE CO-MORBID
CONDITIONS AND HOW WE THINK
ABOUT THE DESIGN AND
IMPLEMENTATION OF THOSE PHASE 3
TRIALS TO UNDERSTAND THE
IMPORTANCE OF PRODUCTS UNDER
REVIEW. I THINK THIS IS
CRITICAL. THEN THE OTHER I THINK
REAL REAL NEED IS AROUND THE
RARE DISEASE SPACE BECAUSE WE
HAVE THIS SPECIAL EXPERTISE IN
THAT SPACE, I THINK THAT THAT
WOULD HELP US THINK THROUGH
THOSE DESIGNS EVEN BETTER
WITHOUT THAT RESTRICTION. WE
WOULDN'T HAVE TO STOP MOMENTUM
OF A PARTICULAR STUDY MOVING
FROM PERHAPS PHASE 2 TO PHASE 3
WHILE WE AWAIT APPROVALS FOR
RARE DISEASES. WE HAVE TO
USUALLY WAIT FOR COUPLE OF O
MONTHS IN THE FEDERAL REGISTRAR
BEFORE WE CAN PROCEEDS WITH
THESE THREE TRIALS FOR RARE
DISEASES, FOR OTHERS WE ARE
STILL PROHIBITED. AND THAT
PARTICULAR TIME REQUIREMENT WE
LOSE GROUNDS IF WE HAVE TO STOP
THOSE SO FOR A VARIETY OF
REASONS YOU ARE DEFINITELY ON
POINT. AND I I HOPE WE CAN
FIGURE WAYS TO NAVIGATE THIS. WE
HAVE TO AT A TIME DONE A REALLY
GOOD JOB BUT TIME TO THINK HOW
TO DO A LITTLE MORE. THANK YOU.
SERGIO, YES, PLEAS PLEASE.
>> JUST TWO MORE COMMENTS, JONI.
ONE IS THANK YOU FOR PRESENTING
THE THIRD EDITION OF THE
PRINCIPLES OF COMMUNITY
ENGAGEMENT AND -- WE GREATLY
APPRECIATE THAT.
>> CONGRATULATIONS TO YOU.
>> AND TO MANY, MANY OTHER
PEOPLE. THESE ONES ARE COLLECTED
EFFORTS WITH MANY, MANY
COMMUNITY MEMBERS. SO IT IS
ABSOLUTELY WORTH CHECKING THAT
OUT. THANK YOU FOR THE LINK
THAT YOU INCLUDED AS WELL. JUST
A COUPLE OF HIGHLIGHTS THAT I
WANT TO COMPLIMENT WHAT YOU
SAID. ONE IS THAT THERE IS A
NEW PRINCIPLE FIRST EDITION AND
SECOND HAD ONLY NINE PRINCIPLES
BUT THIRD EDITION HAS A
PRINCIPLE ON TRUSTWORTHINESS AS
A FOUNDATIONAL ELEMENT FOR
ADVANCING HEALTH AND HEALTH
EQUITY. I WOULD ENCOURAGE THOSE
IN ATTENDANCE TO CHECK IT OUT.
ALSO THERE ARE 14 EXEMPLARS OR
CASE STUDIES THAT ILLUSTRATE THE
USE OF THE PRINCIPLES AS WELL.
THERE IS A NEW DEFINITION OF
COMMUNITY ENGAGEMENT THAT I
REALLY LIKE. CHECK IT OUT, I
THINK THAT IS A LOT OF POP WAS
PUT TOGETHER TO REALLY IMPROVE
PREVIOUS DEFINITIONS. ONE LAST
THING TO MENTION IS TO MAKE A
PLUG BECAUSE CHAPTER 1 THAT
INCLUDES SOME CONCEPTION MODELS
OF COMMUNITY ENGAGEMENT INCLUDES
THE NATIONAL ACADEMY OF MEDICINE
ASSESSING MEANINGFUL COMMUNITY
ENGAGEMENT CONCEPTUAL MODEL. I
THINK THOSE FROM MY PERSPECTIVE
TO LAND MARK CIBCS THIS YEAR FOR
CONTRIBUTIONS FORBRINGING IN COT
SO THANK YOU FOR BRINGING THAT
ATTENTION.
>> THANK YOU, I'M SO GLAD YOU
ADDED THAT POINT, ALL OF THOSE
POINTS BUT THAT -- TALKING ABOUT
THE NATIONAL ACADEMIES
INVOLVEMENT FOR THAT PARTICULAR
ASPECT. ONE OF THOSE THINGS THAT
INSPIRED ME TOO, BECAUSE OF THE
WORK THEY HAVE DONE. WHEN I
THOUGHT ABOUT THAT PARTICULAR
SECTION AND WHAT NATIONAL
ACADEMIES REPORT DID WAS IT MADE
YOU THINK YOUR ASSUMPTIONS THAT
YOU MAKE WHEN COW DO COMMUNITY
ENGAGEMENT. IT REALLY CHALLENGES
THOSE ASSUMPTIONS. SO TAKING
NOTE OF THAT I THINK IS I THINK
THE PRINCIPLES THE THIRD EDITION
DOES A NICE JOB OF TALKING ABOUT
THAT. THANK YOU SO MUCH, SERGIO,
FOR YOUR LEADERSHIP AND THE
WHOLE COMMUNITY FOR THEIR
INVOLVEMENT IN THIS BODY OF
WORK. IT IS FANTASTIC.
>> MY PLEASURE. ONE LAST COMMENT
JONI, I'M SORRY I'M SPEAKING TOO
MUCH PERHAPS. I'M DELIGHTED
THAT TO SEE IN THE WEBSITE THAT
2025, 2030 STRATEGIC PLAN IS
AVAILABLE. BECAUSE THAT IS SUCH
A REMARKABLE CONTRIBUTION THAT
NCATS NEED WITH THIS INCREDIBLE
ELABORATE APPROACHES. LISTENING,
LISTENING TO COMMUNITIES,
LISTENING SESSIONS THAT YOU LED
THAT ARE INFORMED BY VARIOUS
GROUPS OF INTEREST INCLUDING
COMMUNITIES. SO I'M DELIGHTED
THAT YOU TOUCH BASE IN TERMS OF
IMPLEMENTATION PLAN NOW AND
UPDATES YOU MENTIONED. THANK YOU
O FOR DOING THAT.
>> THANK YOU VERY MUCH. IT WAS A
LONG PROCESS TO GO THROUGH IN
TERMS OVERRAN TABLE DISCUSSIONS
BUT BOY WERE THEY VALUABLE. WE
COULDN'T DO IT WITHOUT THE
COMMUNITY, WE HAVE TO BE REALLY
THINKING ABOUT HOW WE RECOLLECT
WORK TOGETHER TO MAKE ADVANCES
HAPPEN. I COULDN'T THINK OF A
BETTER WAY SO I APPRECIATE YOU
RECOGNIZING THAT CONTRIBUTION.
THANK YOU. PAUL.
>> THANK YOU FOR ADDRESSING THE
LETTER THAT WE WROTE LAST TIME
ASKING FOR CONSIDERATION OF
ELEVATION TO AN INSTITUTE. I
THINK WE ARE ALL SUPPORTIVE OF
THAT. IN THE NEWS CYCLE HOWEVER,
THERE IS A LOT OF INFORMATION
OUT THERE ABOUT RESTRUCTURING
NIH. AND POTENTIAL WAYS TO DO
THAT. CAN YOU SPEAK TO THAT A
LITTLE BIT AS MUCH AS YOU CAN?
>> YES, THANKS FOR THAT
QUESTION, PAUL. I CAN BE
WATCHING THE NEWS CYCLES AS MUCH
AS YOU PROBABLY HAVE THE PAST
FEW DAYS OR LAST 24 HOURS. TO BE
CLEAR, I DON'T KNOW MORE THAN
WHAT HAS BEEN REPORTED IN THE
MEDIA FROM LAST NIGHT. HERE IS
WHAT I WOULD SAY TO THAT. WHAT
WAS REPORTING IN MEDIA IS
ESSENTIALLY THE OFFICE OF THE
MANAGEMENT AND BUDGET OMB
PROPOSED DRAFT. WHICH IS PART OF
THE INTERNAL DELIBERATIONS FOR
THE FY 26 PRESIDENT'S BUDGET.
THIS INTERNAL PROCESS ULTIMATELY
HELPS SHAPE THE PRESIDENT'S
BUDGET AND BUT THAT HASN'T COME
OUT YET, IT IS EXPECTED
RELATIVELY SOON IN THE NEAR
FUTURE. SO THE ORGANIZATION AND
THE PROGRAMMATIC CHANGES THESE
TYPES OF THINGS AREN'T
NECESSARILY NEW. AND ARE ALSO
VERY COMMON WITH EVERY NEW
ADMINISTRATION. NOW WHAT YOU
MAY HAVE READ LOOKS PROBABLY
MORE THAN OTHER TIMES WE HAVE
SEEN. TOO EARLY TO UNDERSTAND
THAT AND SINCE IT IS THE OMB
PROPOSED DRAFT IT IS
INAPPROPRIATE FOR ME TO COMMENT
TOO MUCH ON THAT. I CAN PROVIDE
A LITTLE BACKGROUND ON THE
PROCESS. THE PRESIDENT'S BUDGET
IS THING THAT KICKS OFF THE FY
26 APPROPRIATIONS PROCESS IN
CONGRESS. PRESIDENT'S BOUGHT IS
EXPECTED IN THE NEAR FUTURE.
THAT BUDGE PROCESS ONCE THAT IS
OUT IT LASTS SEVERAL MONTHS WITH
THE GOAL OF LANDING ON A FINAL
BUDGET BY THE BEGINNING OF THE
NEW FISCAL YEAR IN FY 26 WHICH
STARTS OCTOBER 21. SO THERE IS A
COUPLE OF MONTHS TO GO STILL AND
UNDERSTANDING HOW THIS IS IS
GOING TO PLAY OUT. THE PROCESS
INCLUDES MANY HEARINGS WITH
VARIOUS DEPARTMENTS AND AGENCY
LEADERS. AS WELL AS THE HOUSE
AND THE SENATE APPROPRIATIONS
COMMITTEES. THE HOUSE AND SENATE
APPROPRIATION COMMITTEES WILL
GET INPUT FROM ADMINISTRATION,
THEY WILL BUILT DRAFTS AND BILLS
AND THEN THE REPORT LANGUAGE
THAT CONGRESS ULTIMATELY VOTES
ON RELATED TO THIS. THAT IS
ESSENTIALLY THE PROCESS. THIS IS
SIGNIFYING THAT PROCESS IS ABOUT
THE START BUT THIS IS REALLY
PROPOSED DRAFT WE HAVE SEEN. I
JUST HAVEN'T -- I DON'T KNOW
MUCH MORE HABIT THAT AT THIS
TIME. THIS TIME OF COURSE NCATS
WILL CONTINUE TO BE GROUNDED IN
OUR MISSION OF BRINGING MORE
TREATMENTS TO ALL PEOPLE MORE
QUICKLY. AS I SHOWED TODAY, I
THINK WE DO A PRETTY GOOD JOB OF
THAT BECAUSE OUR TEAM SCIENCE
APPROACH AND WORKING ACROSS THE
NIH AND WORKING ACROSS THE
ENTIRE BIOMEDICAL ECOSYSTEM IS
HOW WE HAVE BEEN ABLE TO BE
SUCCESSFUL IN THAT RASH. SO
PROBABLY DIDN'T ANSWER YOUR
QUESTION VERY WELL BUT HOPE THAT
GAVE YOU A LITTLE INSIGHT INTO
WHAT HAPPENS NEXT.
>> THANK YOU. I ASKED AS MUCH AS
YOU COULD AND YOUOVER DELIVERED
SO THANK YOU.
>> THANK YOU. ARE THERE ANY
OTHER QUESTIONS? I DON'T SEE ANY
HANDS. OKAY. IN THAT CASE,
ANNA, I THINK I MIGHT WANT TO
TURN IT OVER TO YOU. SINCE OUR
OPENING DIRECTOR'S REPORT IS NOW
CONCLUDED. SHALL I TURN IT OVER
TO YOU? ANNA, ARE YOU THERE? WE
MAY HAVE LOST ANNA. I HOPE WE
DIDN'T LOSE THE ROOM.
>> THE AUDIO COMING THROUGH.
SPEAKER5: ANNA IS -- OKAY. ANNA
IS HERE. SHE MOVED. I BELIEVE WE
ARE ON ANY PUBLIC COMMENTS.
>> YES.
>> OKAY. SHALL I PUT THE VIDEO?
>> WE DO HAVE A COUPLE OF PUBLIC
COMMENTS RECEIVED IN THE INPUT
BOX. WE USUALLY DO NOT ANSWER
THOSE OR RESPOND TO THOSE LIVE
BUT TODAY I BELIEVE WE CAN GO
AHEAD AND PROVIDE RESPONSE TO
FOLKS WHO BOTHER TO SUBMIT THEM
TODAY AND REMIND EVERYONE THAT
COMMENTS CAN BE SUBMITTED UNTIL
MAY 1 AND THEY CAN BE MADE
AVAILABLE UPON REQUEST. SO THE
FIRST QUESTION, I WILL READ IT.
IS AFTER THE NEW ADMINISTRATION
AND NIH LEADERSHIP HAS COME
INTHE PLACE, GRANTS PROPOSED AND
DELAYED, DESCRIBE TIMING TO
RESUME AID WARDING OF THE
BACKLOG OF SBIR STTR GRANTS,
WHAT IS PLAN REVIEWING AWARDING
SBIR STTR GRANTS PHYSICAL YEAR.
HAPPY T TO A-- FISCAL YEAR. THOE
REVIEWS HAVE RESUMED AND WE
ANTICIPATE AWARDS WILL BE MADE
THOUGH MAYBE SOMEWHAT DELAYED.
THE OTHER QUESTION WE RECEIVED
WAS WHICH OF THE SEVEN COUNTRIES
IN TRANSLATIONAL -- TRANSLATION
TOGETHER PROGRAM AND THE LIST
THAT WE HAVE AVAILABLE IS
CANADA, JAPAN, BRAZIL, UK,
AUSTRALIA, WE ARE ONE OF THE
SEVEN, AND THE EU BEING HANDLED
AS A COUNTRY IN THIS CONTEXT.
THUS FAR WE HAVE NOT RECEIVED
ADDITIONAL COMMENTS. AGAIN,
COMMENTS ARE ACCEPTABLE UNTIL
MAY 1, THEY WILL BE MADE PUBLIC
IF REQUESTED. THANK YOU.
>> ALL RIGHT. THANK YOU, ANNA.
FOR DOING THE ROTATION OF THE
CAMERA. IN THAT CASE, I BELIEVE
THAT ANY OTHER QUESTIONS OR
COMMENTS, THEN WE CAN CONCLUDES
THE -- CONCLUDE THE OPEN COUNCIL
TODAY. ONE MORE MINUTE IN CASE
THERE ARE. I WANT TO SAY THANK
YOU --. YES. GO AHEAD.
>> I WANT TO SAY THANK YOU, WE
APPRECIATE YOUR LEADERSHIP AND
APPRECIATE YOU IN THE STAFF FOR
ACCOMMODATING THIS MEETING AND
INFORMATIVE NATURE OF IT.
>> THANK YOU VERY MUCH, PAUL.
THAT MEANS A LOT TO ME, MEANS A
LOT TO OUR STAFF. I APPRECIATE
HEARING THAT FROM OUR COUNCIL SO
THANK YOU.
>> I STRONGLY ECHO THAT.
>> IT'S UNANIMOUS.
>> THANK YOU ALL. JONATHAN, DID
YOU HAVE ANOTHER COMMENT?
>> NO, IT WAS TO SAY THANK YOU
SO MUCH FOR YOUR LEADERSHIP. AND
FOR YOUR GREAT STAFF IN ALL THAT
THEY DO.
>> FANTASTIC. THANK YOU SO MUCH.
WITH THAT, WE WILL CONCLUDE THE
OPEN SESSION SO I WILL GAVEL US
OUT. THANK YOU, EVERYONE.
>> BYE-BYE.