WELCOME TO THE 60th MEETING OF
THE NATIONAL ADVISORY COUNCIL
FOR BIOMEDICAL IMAGE AND
BIOENGINEERING.
I'M DAVE GEORGE, NIBIB ASSOCIATE
DIRECTOR, ASSOCIATE SECRETARY OF
THIS COMMITTEE.
THIS COUNCIL MEETING IS OPEN TO
THE PUBLIC, EXCEPT FOR THE
REVIEW OF PENDING GRANT
APPLICATIONS WHICH WILL TAKE
PLACE LATER THIS AFTERNOON.
THE OPEN SESSION OF THE COUNCIL
MEETING IS BEING LIVE BROADCAST
ON THE NIH VIDEOCAST NETWORK,
AND RECORDED FOR NIH ARCHIVES.
THE COMMITTEE AND PRESENTERS ARE
PARTICIPATING VIA VIDEO
CONFERENCE.
I'D LIKE TO WELCOME OUR COUNCIL
MEMBERS, EX OFFICIO, SPECIAL
GUESTS.
THANK YOU TO ALL THOSE WATCHING
ON VIDEOCAST.
THOSE OF YOU MEMBERS OF THE
PUBLIC WHO WISH TO EXPRESS VIEWS
REGARDING ANY ITEMS DISCUSSED
DURING THIS MEETING MAY DO SO IN
WRITING WITHIN TEN DAYS, INFO@
NIBIB.NIH.GOV.
THAT'S INFO@NIBIB.NIH.GOV.
AND PLEASE PUT NIBIB COUNCIL IN
THE SUBJECT LINE OF THE E-MAIL.
FOR THOSE WHO ARE IN THE VIDEO
CONFERENCE, YOU'RE FAMILIAR WITH
THIS BY NOW BUT REMINDERS, MUTE
YOURSELF WHEN NOT SPEAKING, FOR
COLLEAGUES AND GUESTS WHO ARE
PRESENTING A REMINDER TO PRESENT
FROM A FILE LOCATED ON YOUR
COMPUTER'S HARD DRIVE RATHER
THAN NETWORK DRIVE AND BE LOGGED
OR VPN AND SHUT OFF UNNEEDED
SOFTWARE NOTIFICATIONS IF YOU
CAN.
THE CHAT BOX IS ENABLED FOR YOU
TO CONTACT OUR HOST
OUR I.T. COLLEAGUE, WHO IS
MANAGING THE VIDEO CONFERENCE
TODAY.
AS WELL IN ADDITION, IF YOU WANT
TO CONTACT HIM VIA E-MAIL FOR
ANY TECHNICAL PROBLEMS, HIS
E-MAIL ADDRESS IS
RYAN.DAVA@NIH.GOV.
I'D LIKE TO NOTE FOR THE RECORD
WE HAVE A QUORUM FOR TODAY'S
MEETING.
I'D LIKE TO THANK NIBIB
COMMITTEE MANAGING OFFICER PAM
GLICKMAN AND COMMITTEE MANAGING
SPECIALIST ALICIA HOPKINS FOR
THEIR HELP IN GETTING THE
MEETING ORGANIZED AND HELPING
GET THE INSTITUTE TO THIS THRICE
ANNUAL MEETING AND AGAIN TO RYAN
AND OUR NIBIB I.T. COLLEAGUES,
OUR NIH VIDEOCAST COLLEAGUES,
AND OTHER STAFF MEMBERS WHO
WORKED ON THE VIDEO
ARRANGEMENTS.
THE PROCEEDINGS ARE GOVERNED BY
THE FEDERALLY ADVISORY COMMITTEE
ACT, FACA, AND THE GOVERNMENT IN
THE SUNSHINE ACT, SO THIS MEANS
THE MEETING WAS ANNOUNCED TO THE
PUBLIC IN THE FEDERAL REGISTER,
AND CONSISTS OF OPEN PORTION
THAT WE'RE IN NOW AND THEN A
CLOSED PORTION THAT WILL BE
LATER IN THE AFTERNOON, WE'LL
TALK ABOUT INDIVIDUAL
APPLICATIONS, WE ANTICIPATE
ADJOURNING THE OPEN SESSION AT
ABOUT 2:30.
IN TERMS OF FUTURE COUNCIL
DATES, THEY ARE LISTED AT THE
BOTTOM OF THE AGENDA, COUNCIL
MEMBERS IN THE ELECTRONIC
COUNCIL BOOK.
WE ASK IF YOU COULD DOUBLE CHECK
THOSE FUTURE DATES, MAKE SURE WE
DIDN'T ACCIDENTALLY SCHEDULE A
MEETING ON TOP OF A CONFERENCE
THAT MAY TAKE AWAY A NUMBER OF
YOU AND CAUSE CONFLICTS.
NEXT MEETING WILL BE JANUARY 25,
2023.
AND THE JANUARY MEETING WILL
AGAIN BE HELD BY VIDEO
CONFERENCE.
I'D LIKE TO MOVE INTO THE
CONSIDERATION OF THE MINUTES AND
COUNCIL OPERATING PROCEDURES.
AGAIN, WE POSTED THOSE TWO ITEMS
INTO THE ELECTRONIC COUNCIL
BOOK, IN REPRESENT OPERATION FOR
BODYING, COUNCIL MEMBERS, UNMUTE
YOURSELVES IN PREPARATION FOR
CASTING A VOICE VOTE.
ARE THERE ANY COMMENTS OR
MODIFICATIONS YOU'D LIKE TO MAKE
TO THE MINUTES?
OKAY, HEARING NONE I'LL
ENTERTAIN A MOTION TO APPROVE
THE MINUTES.
>> I MOVE.
>> SO MOVED.
>> SECOND?
>> SECOND.
>> ALL IN FAVOR, AYE.
>> AYE.
>> ALL OPPOSED, NAY.
OKAY.
THANK YOU VERY MUCH.
NOW WE'LL MOVE TO THE COUNCIL
OPERATING PROCEDURES.
WE MADE A MINOR TWEAK TO BE
CONSISTENT WITH NIH POLICY, MADE
AVAILABLE A COUPLE WEEKS AGO.
ARE THERE ANY COMMENTS OR
MODIFICATIONS YOU'D LIKE TO MAKE
TO OPERATING PROCEDURES?
OKAY, AGAIN HEARING NONE I'LL
ENTERTAIN A MOTION TO APPROVE
THE OPERATING PROCEDURES.
>> SO MOVED.
>> MOVED.
>> SECOND?
>> SECOND.
>> ALL IN FAVOR SAY AYE.
>> AYE.
>> ALL OPPOSED, NAY.
OKAY.
THOSE PASS.
SO THANK YOU VERY MUCH.
WITH THAT OPENING WE'LL MOVE
INTO THE DIRECTOR'S REMARKS,
GIVEN BY NIBIB DIRECTOR BRUCE
TROMBERG AND DEPUTY DIRECTOR
JILL HEEMSKERK.
>> THANK YOU, DAVE, I'LL SHARE
MY SCREEN.
AND ACTUALLY BEFORE I DO THAT,
WE HAVE A TRADITIONAL HOLLYWOOD
SQUARES MOMENT.
I KNOW THIS DOESN'T DO MUCH TO
REALLY RECREATE THE LIVE FEELING
BUT IF WE COULD TAKE A MOMENT TO
FLASH ON AND SAY HI.
MANY OF US HAVE BEEN FRIENDS AND
COLLEAGUES, COLLABORATORS OVER
SO MANY YEARS.
AS YOU KNOW, IT'S FRUSTRATING TO
BE IN THIS VERY STRUCTURED ZOOM
ENVIRONMENT, WHICH DOESN'T ALLOW
FOR ALL THE PARALLEL
CONVERSATION, PROCESSING,
BACKROOM DISCUSSIONS.
WE'LL HAVE, YOU'LL SEE IN ONE OF
MY SLIDES, WE'LL HAVE A LIVE
COUNCIL MEETING, WE HOPE, IN
MAY.
AND I THINK THAT WILL BE AN
ANNUAL EVENT, IF IT'S
SUCCESSFUL, MAYBE MORE, BUT HARD
TO LOOK TOO FAR INTO THE FUTURE.
WE'RE JUST FOCUSING ON THAT
FIRST BACK-TO-LIVE MEETING IN
MAY.
THANK YOU ALL FOR COMING.
THANK YOU.
WE HAVE A VERY PACKED PROGRAM AS
USUAL.
WE'RE ALWAYS A LITTLE BIT OVERLY
AMBITIOUS.
WE'RE A SMALL INSTITUTE BUT
THINK WE CAN HAVE A LOT OF
IMPACT.
SO THAT'S KIND OF ONE OF OUR
CHARACTERISTICS.
I THINK OF OUR ENTIRE FIELD AND
OUR WHOLE COMMUNITY.
SO, I'M NOW GOING TO GO AHEAD
AND SHARING THE SCREEN.
I DON'T WANT TO WASTE TIME WITH
MY PREAMBLE.
OKAY.
THANK YOU SO MUCH, DAVID, AS
DAVID POINTED OUT THIS IS A
REALLY HUGE TEAM EFFORT, THANKS
TO DAVE FOR ALL THE WORK HE DOES
IN ORGANIZATION.
PAM AND ALICIA WHO WE'LL TORTURE
IF WE DO A LIVE MEETING BUT THEY
ARE FANTASTIC AT THIS AND WE
APPRECIATE THEIR WORK.
SENIOR LEADERSHIP, JILL WILL
HELP ME ON COUNCIL SLIDES, AND
JASON, RICHARD, CHRIS, ENTIRE
NIBIB CONTRIBUTED TO THESE.
SPEAKING OF TORTURING, ABOUT TWO
WEEKS AGO WE DO -- ABOUT TWO
WEEKS BEFORE COUNCIL MEETING WE
GET TOGETHER AND GO THROUGH
CANDIDATE SLIDES AND REALLY
DISCUSS WHAT MAY GO INTO THE
COUNCIL PRESENTATION AND HAVE AN
INCREDIBLE SLIDE TEAM.
THANK YOU TO THE SLIDE TEAM.
THEY WORK WITH ALL OF OUR STAFF
TO VET IDEAS AND GET THEM INTO
SLIDES AND THEN WE SPEND
ANYWHERE BETWEEN AN
HOUR-AND-A-HALF AND TWO HOURS A
COUPLE WEEKS BEFORE COUNCIL
GOING THROUGH THESE.
SO THANK YOU TO THE TEAM.
AND AS I MENTIONED, WE LOOK
FORWARD TO MEETING IN PERSON,
HOPEFULLY.
AND TO INSPIRE YOU, I HAVE A
NICE PICTURE FROM THE BOLGER
CONFERENCE CENTER, OUR
TRADITIONAL MEETING LOCATION,
CLOSE TO THE NIH LOCATION BUT
DOES NOT HAVE SECURITY AND THEY
HAVE MUCH BETTER OATMEAL RAISIN
COOKIES AND PRESENTATION TREATS.
HOPEFULLY WE CAN GET BACK IN
MAY, MAY 16, MARK THAT DATE ON
YOUR CALENDAR.
PAM AND ALISHA WILL BE LEADING
THE EFFORT TO GET US INTO BOLGER
OR POSSIBLY ANOTHER FACILITY.
I HAVE A LOT ON THE AGENDA.
SO MANY I THOUGHT I WOULD PUT AN
OUTLINE TOGETHER SO I'M GOING TO
START WITH WELCOMING OUR NEW
COUNCIL MEMBERS, TRADITIONAL
THING THAT WE DO IN SEPTEMBER AS
WELL AS NIBIB STAFF AND WHAT
EVERYBODY IS ALSO INTERESTED IN,
OUR BUDGET UPDATES.
SO, FIRST CYNTHIA MCCULLOUGH,
WELCOME, CYNTHIA.
MANY OF YOU KNOW CYNTHIA,
PROFESSOR OF MEDICAL PHYSICS AND
BIOMEDICAL ENGINEERING, DIRECTOR
OF MAYO CT CLINICAL INNOVATION
CENTER, USING CF FOR
QUANTITATIVE ASSESSMENT, DISEASE
PROGRESSION AND REGRESSION,
ORGAN FUNCTION, AS WELL AS
METHODS TO QUANTIFY AND REDUCE
PATIENT DOSE.
I HAVE TO SAY WHEN I WAS A
COUNCIL MEMBER I SAW CYNTHIA
GIVE A TALK ON ALL OF THESE
TOPICS AND WAS COMPLETELY BLOWN
AWAY.
I THINK MY FOUNDATIONAL
KNOWLEDGE OF CT ON ALL OF THESE
TOPICS REALLY COMES FROM THAT
PRESENTATION FROM CYNTHIA.
SHE'S A FELLOW OF THE AMERICAN
COLLEGE OF RADIOLOGY AND AAPM,
RECENTLY A RECIPIENT OF MAYO'S
DISTINGUISHED INVESTIGATOR
AWARD.
SO WELCOME, CYNTHIA.
ALSO, DAN IS A PROFESSOR OF
RADIOLOGY AS WELL AS
NEUROSCIENCE AND PHYSIOLOGY AT
NYU IN THEIR SCHOOL OF MEDICINE,
DIRECTOR OF THE SCHWARTZ CENTER
FOR BIOMEDICAL ENGINEERING, VIE
CHAIR FOR RESEARCH AND
RADIOLOGY, HIS RESEARCH HAS
PIONEERED RAPID PARALLEL MRI
TECHNIQUES, BUT HE'S ALSO VERY
WELL KNOWN FOR HIS PIONEERING
WORK IN TECHNOLOGIES AND
COMPUTATIONAL METHODS, IMAGE
ACQUISITION, HE WORKS ON INVERSE
PROBLEMS, COMPRESSED SENSING,
ELECTROMAGNET ISSUE TISSUE
INTERACTION AND INTERPRETATION
OF ISSUES, A.I. AND
MULTI-MODALITY IMAGING AND
PRINCIPAL INVESTIGATOR OF ONE OF
OUR JEWELS IN THE TECHNOLOGY
CROWN P41 CENTER FOR ADVANCED
IMAGING INNOVATION AND RESEARCH.
THIRD IS JOYCE WONG, AND I THINK
EVERYONE KNOWS JOYCE, PROFESSOR
OF BIOMEDICAL ENGINEERING AT
BOSTON UNIVERSITY, RESEARCH IS
BASIC ON STRUCTURE AND MATERIAL
PROPERTIES AND COMPOSITION OF
CELL BIOMERELY ENTER TASTES,
AFFECT CELLULAR PROCESSES AND
TAKES THAT BASIC KNOWLEDGE TO
DESIGN CELL MATERIAL INTERFACES
BOTH TO DETECT AND TREAT
DISEASE.
PRACTICAL APPLICATIONS AS WELL
AS FUNDAMENTAL KNOWLEDGE IN THIS
AREA.
JOYCE IS CURRENTLY PRESIDENT AND
FELL AIMBE, SHE'S A FELLOW OF
THE NATIONAL ACADEMY OF
INVENTORS, BMES, AAAS, IAMBE AND
WON THE SOCIETY FOR BIOMATERIALS
CLEMSON AWARD, IS ACTIVE IN
DIVERSITY ACTIVITIES AND ONE OF
THE INTERESTING THINGS THAT
CAUGHT OUR EYE IS SHE'S THE
INAUGURAL DIRECTOR OF A PROGRAM
CALLED ARROWS, WHICH IS, OH
GOSH, YOU'LL HAVE TO ASK JOYCE,
I FORGOT WHAT IT STANDS FOR.
BUT THIS IS AN ORGANIZATION THAT
IS FOCUSED ON PROMOTING WOMEN IN
STEM AT BOSTON UNIVERSITY, IT'S
I THINK IN MANY WAYS A MODEL FOR
THE TYPES OF PROGRAMS THAT ALL
UNIVERSITIES COULD ADOPT IF
YOU'RE NOT REALLY LAUNCHING A
PROGRAM LIKE THIS.
IT'S REALLY AN IMPORTANT ONE,
AND JOYCE I THINK CAN FILL YOU
IN ON DETAILS OF THAT.
NOW WE HAVE SOME NEW NIBIB STAFF
TO INTRODUCE.
IN THE OFFICE OF SCIENTIFIC
REVIEW, ALEXANDER IS A
SCIENTIFIC REVIEW OFFICER, AND
HE WAS ASSISTANT PROFESSOR IN
DEPARTMENT OF BIOMEDICAL
ENGINEERING AT GEORGE MASON
UNIVERSITY, HAS OVER 30 YEARS OF
BENCH AND COMPUTATIONAL RESEARCH
EXPERIENCE IN NEUROPHYSIOLOGY,
COMPUTATIONAL NEUROSCIENCE,
INFORMATICS, MODELING BIOLOGICAL
SYSTEMS, INFORMATION PROCESSING.
AND HE WILL BE VERY ACTIVE IN
CONTRIBUTING HIS EXPERTISE TO
OUR SPECIAL REVIEWS THAT WE DO
WITHIN NIBIB.
WE ALSO WELCOME LAVANE TERRELL,
EXTRAMURAL SUPPORT ASSISTANT IN
OSR, OVER 15 YEARS OF
PROFESSIONAL EXPERIENCE AND
EXECUTIVE AND PROGRAM
ASSISTANCE, SHE CAME FROM DCU
GOVERNMENT, EXPERIENCE IN
UNDERSTANDING BOTH FEDERAL
STRUCTURE AS WELL AS LOCAL
GOVERNMENT STRUCTURES.
SHAWN MULVANEY IS A NEW PROGRAM
OFFICER DIVISION OF HEALTH
INFORMATICS TECHNOLOGIES, SHAWN
SPENT MORE THAN TWO DECADES AS A
SCIENTIST AT U.S. NAVAL RESEARCH
LAB WORKING ON CHEMICAL AND
BIOLOGICAL SENSING, AND HE
SPECIALIZES IN A LOT OF REALLY
IMPORTANT AREAS THAT ARE
DIRECTLY IMPACTING OUR RADx
PROGRAM, BIOTIC, ABIOTIC
INTERFACE, DEVICE PROTOTYPING, A
HUGE AMOUNT OF EXPERIENCE
BUILDING BIOSENSOR PLATFORMS
WHICH HE'S DONE FOR FIRST
RESPONDERS AND ALSO USE BY WAR
FIGHTERS.
AS I MENTIONED HE'S HAD LOTS OF
EXPERIENCE WITH RADx, ON
DETAIL AND NOW AS A MEMBER OF
NIBIB, IMPACTFUL, A LARGE
PORTFOLIO OF AT LEAST TEN
TECHNOLOGIES, A MEMBER OF OUR
FUNDING PANEL.
SO DAVID GUTEKUNST IS IN THE
DIVISION OF INTERDISCIPLINARY
TRAINING.
HIS EXPERTISE IS IN MOVEMENT
SCIENCE AND BIOMECHANICS, FOCUS
ON LOWER EXTREMITY
MUSCULOSKELETAL INJURY
MECHANISMS, PRIOR TO THIS HE WAS
ASSISTANT PROFESSOR IN
BIOMEDICAL ENGINEERING AT THE
MAYO CLINIC, AFTER THAT
ASSISTANT PROFESSOR IN
DEPARTMENT OF PHYSICAL THERAPY
AT ST. LOUIS UNIVERSITY.
HE JOINED NIH AS AAAS FELLOW IN
NICHD'S NATIONAL CENTER FOR
REHABILITATION RESEARCH, AND
DAVID'S FACULTY AS WELL AS
RESEARCH EXPERIENCE AND
UNDERGRADUATE AND Ph.D.
TRAINING IN BIOMEDICAL
ENGINEERING FROM WASH U ARE A
PERFECT FIT FOR OUR TRAINING
POSITION.
WE HAVE THREE MORE STAFF TO
INTRODUCE, AND THIS IS ALL THREE
JOINED THE DIVISION OF DISCOVERY
SCIENCE AND TECHNOLOGY, THE
FIRST JERMONT CHEN HAS A
BACKGROUND IN CHEMISTRY, AIR
FORCE ACADEMY GRADUATE, WIDE
RANGE OF EXPERIENCES SPANNING
FROM WORKING AS ASSISTANT
PROFESSOR IN DEPARTMENT OF
CHEMISTRY AT THE AIR FORCE
ACADEMY, TO SERVING AS FUELS AND
ENERGY BRANCH CHIEF IN THE
AEROSPACE SYSTEMS DIRECTORATE OF
THE AIR FORCE RESEARCH
LABORATORY.
MOST RECENTLY HE WAS DEPUTY
DIRECTOR AND INTERNATIONAL
PROGRAM IN INTERNATIONAL OFFICE
IN TOKYO WHERE HE BUILT A
PORTFOLIO IN SYNTHETIC BIOLOGY
ROBOTICS, NANOSCIENCE, AN IDEAL
FIT FOR OUR DIVISION.
JESSICA FALCONE COMPLETED
Ph.D. FAIRLY RECENTLY AT
GEORGIA TECH IN NEURAL
ENGINEERING STUDYING BRAIN
ELECTRODES, POSTDOC AT THE
FEINSTEIN INSTITUTE FOR MEDICAL
RESEARCH WORKING ON VAGAS
NERVES, COMES FROM CITY WHERE
SHE WAS WORKING AT TUCKER DAVIS,
THAT BUILDS RESEARCH SYSTEMS FOR
NEUROSCIENTISTS.
FINALLY LEE SIMS IS JOINING
NIBIB AS A AAAS FELLOW, SCIENCE
AND TECHNOLOGY POLICY FELLOW FOR
AAAS.
PRIOR TO THIS HE WORKED AS
TECHNICAL ADVISER FOR USAID,
AGENCY FOR INTERNATIONAL
DEVELOPMENT, SUPPORTED A GLOBAL
HEALTH TECHNOLOGY RESEARCH AND
DEVELOPMENT PROGRAM EFFORT THERE
SO BRINGS THAT PERSPECTIVE TO
OUR WORK.
BACKGROUND IS IN BIOENGINEERING
AND EPIDEMIOLOGY WITH RESEARCH
FOCUSING ON APPLICATION OF
BIOMATERIALS FOR NANOTECHNOLOGY,
TRANSPORT AND DIFFUSION MODELING
OF NANOPARTICLE SYSTEMS, HAS A
GREAT TECHNICAL BACKGROUND, ALSO
STRONG GLOBAL HEALTH INTEREST.
IF WE WERE LIVE IN PERSON WE
WOULD GIVE EVERYONE A ROUND OF
APPLAUSE, BUT THINK OF DOING
THAT VIRTUALLY, WE'RE SO HAPPY
TO HAVE ALL OF YOU JOIN NIBIB.
YOU BRING A WEALTH OF EXPERTISE,
UNIQUE EXPERIENCES, LOTS OF
ENERGY, CREATIVITY AND DRIVE
THAT WILL CONTINUE TO INVIGORATE
THE INSTITUTE AND OUR FIELD.
SO, QUICK BUDGET UPDATE, THE FY
23 APPROPRIATIONS JUST A
SUMMARY, THIS IS THE SENATE
PROPOSED, NIH OVER ALL HAS A
LITTLE OVER $48 BILLION.
THAT'S AN INCREASE OF $3 BILLION
OVER FY 22 LEVELS.
BUT IF YOU'VE BEEN FOLLOWING
BUDGET DISCUSSIONS, THIS IS JUST
THE SENATE PROPOSED BUDGET SO WE
DON'T KNOW WHICH BUDGET WILL BE
ENACTED AND THAT COULD TAKE
QUITE SOME TIME.
WITHIN THIS BUDGET THERE'S AN
AVERAGE OF ABOUT A LITTLE OVER
3% INCREASE FOR INSTITUTES AND
CENTERS, AND THAT'S EXACTLY THE
AMOUNT THAT WAS CALLED OUT THAT
NIBIB WOULD RECEIVE A 3.1%
INCREASE.
AND WE DID ANNOUNCE THIS LAST
TIME BUT HAVEN'T FINALIZED BUT
OUR FY 22 R01 PAYLINE IS 19th
PERCENTILE AND 24 PER CENT FOR
NEW INVESTIGATORS.
THIS IS ESPECIALLY FOR OUR NEW
JOINING COUNCIL MEMBERS.
YOU HAVEN'T SEEN THIS KIND OF
SLIDE BEFORE, BUT ALL OF OUR
ONGOING COUNCIL MEMBERS ARE
QUITE FAMILIAR WITH THIS IMPACT
THAT SUPPLEMENTAL APPROPRIATIONS
HAVE HAD ON NIBIB.
WE KIND OF HAVE TWO NIBIBs.
THERE'S WHAT WE CALL NIBIB 1,
CORE PROGRAMS, AND THEY ARE
FUNDED BY THESE CONGRESSIONAL
APPROPRIATIONS.
YOU CAN SEE THE GROWTH THERE
OVER THE YEARS HAS BEEN FAIRLY
FLAT IN FY 18, $377 MILLION, FY
22 IT'S $422 MILLION.
SO THERE HAS BEEN SOME GROWTH
BUT IT'S MODEST.
AND THEN WITH COVID, AND THE
SUPPLEMENTAL APPROPRIATIONS,
MOST PROMINENTLY IN THE FOURTH
CONGRESSIONAL SUPPLEMENT WHICH
CAME APRIL 24, 2020, NIH OVERALL
RECEIVED $1.5 BILLION, $500
MILLION DIRECTLY TO NIBIB, WE'VE
RECEIVED SEVERAL OTHER SOURCES
IN ADDITION TO THIS $500 MILLION
FROM THE OFFICE OF THE DIRECTOR
AND OTHER AGENCIES, SO OVER THE
PAST THREE YEARS NIBIB HAS
RECEIVED AN ADDITIONAL TOTAL
SUPPLEMENTAL FUNDING OF OVER
$1.7 BILLION, AND THOSE HAVE
BEEN -- FUNDS HAVE BEEN DIRECTED
TO OUR PANDEMIC RESPONSE.
SO NIBIB HAS BEEN CENTRAL IN
THAT RESPONSE, AND WE'VE BEEN
ABLE TO HAVE AN IMPACT IN
IMAGING AND ARTIFICIAL
INTELLIGENCE, IN VITRO
DIAGNOSTICS, AND DIGITAL HEALTH
PLATFORMS WHICH WE'LL UPDATE
EVERYONE ON LATER IN THE
PRESENTATION.
SO, OUR RETURNING COUNCIL
MEMBERS ARE VERY FAMILIAR WITH
THIS, BUT FOR OUR NEW COUNCIL
MEMBERS THIS HAS BEEN THE BIG
STORY BEHIND WHAT'S HAPPENED TO
NIBIB OVER THE PAST FEW YEARS.
SO LET'S TALK ABOUT NIBIB-1,
SPECIAL FUNDING OPPORTUNITIES.
AND YOU ALL HAVE BEEN
FOLLOWING -- THIS IS QUITE AN
AMAZING STORY LED BY RANDY KING,
ALZHEIMER'S DISEASE
ADMINISTRATIVE SUPPLEMENTS,
HOPEFULLY YOU'RE GOING BACK AND
COMMUNICATING THIS TO YOUR
COLLEAGUES.
THIS IS, AGAIN, A NOTICE HAS
BEEN POSTED.
FIRST AVAILABLE DUE DATE IS THE
1st OF OCTOBER.
THESE ARE ONE YEAR OF SUPPORT
REQUESTS, NO MORE THAN $250 IN
DIRECT COSTS, BUT WHAT'S SO
BEAUTIFUL ABOUT THIS IS YOU CAN
HAVE A GRAD WORKING ON A
TECHNOLOGY DEVELOPMENT IN OTHER
AREAS AND BE COMPETITIVE FOR
SUPPLEMENT THAT ALLOWS YOU TO
TAKE WHAT YOU'RE WORKING ON, THE
TECHNOLOGIES YOU'RE DEVELOPING,
AND APPLY THEM TO ALZHEIMER'S
DISEASE, ENCOURAGE YOU TO SPEAK
WITH RANDY, A QUICK SNAPSHOT
HERE, THE IMPACT HAS BEEN QUITE
ASTOUNDING, MORE THAN $16
MILLION OVER THE SIX YEARS THAT
WE'VE BEEN ACTIVE, THAT THIS
SUPPLEMENT PROGRAM HAS BEEN
GOING ON.
YOU CAN SEE THE AMOUNT IN TOTAL
HAS BEEN CREEPING UP A LITTLE
BIT EACH YEAR, SO IN 2022,
$3.4 MILLION AWARDED.
NUMBER OF SUPPLEMENTS IS
CONSTANT, RANGING BETWEEN ABOUT
14 AND 16 AWARDS.
BRAIN FLISH INITIATIVE, YOU
KNOW THERE ARE SUBSTANTIAL
INCREASES IN BRAIN INITIATIVE
FUNDING PARTICULARLY IN
TECHNOLOGY DEVELOPMENT THAT ARE
SLATED.
AND SCHUMAN LANG HAS LED THIS
EFFORT.
THIS IS A NEW RFA PUBLISHED FOR
NON-INVASIVE IMAGING
DEVELOPMENT, UG3 AND UH3
MECHANISM, I DEFINITELY
RECOMMEND YOU SPEAK WITH SHUMIN
IF YOU HAVE AN INTEREST.
THE GOAL IS TO SUPPORT TEAM
BASED DEVELOPMENT, VALIDATION OF
INNOVATIVE NON-INVASIVE IMAGING
TECHNOLOGIES THAT STUDY -- THAT
IMPACT STUDY OF BRAIN FUNCTION
AND CONNECTIVITY.
THE KEY DATES TO KEEP IN MIND
ARE -- WELL, IT'S ALREADY OPEN,
SEPTEMBER 13, DUE DATES FOR THE
APPLICATIONS ARE OCTOBER 13.
THIS IS REALLY RIGHT IN LINE
WITH THE TECHNOLOGIC ACTIVITY
OF OUR COMMUNITY.
THIS IS THE TERM YOU'VE BEEN
HEARING ABOUT CONSTANTLY FOR THE
LAST FEW YEARS, THE POINT OF
CARE TECHNOLOGY RESEARCH
NETWORK.
THIS IS NOW OFFICIALLY REISSUED.
AND POCTRN AS MOST OF YOU KNOW
IS THE FOUNDATION OF THE ENTIRE
RADx PROGRAM, IT'S THE
INSPIRATION FOR WHICH WE
ACTUALLY CAN CONDUCT OR WHAT WE
LIKE TO SAY RADx-IFY OTHER
PARTS OF NIBIB.
IT'S A FIVE-YEAR PROGRAM AND WE
HAVE A RECORD NUMBER OF
INSTITUTES AND CENTERS THAT ARE
INVOLVED THIS YEAR, SEVEN
DIFFERENT I.C.s WILL SUPPORT
APPLICATION-ORIENTED POCTRN
SIDES, AND THERE ARE MORE
DETAILS WITH TECHNICAL
ASSISTANCE WEBINAR THAT ARE
AVAILABLE AND TIFFANI LASH IS
PROGRAM LEADER WHO HAS DEVELOPED
AND DESIGNED THIS PROGRAM, SO
PLEASE DON'T HESITATE TO GET IN
TOUCH WITH TIFFANI, PARTICULARLY
AS WE'RE LOOKING TO EXPAND THESE
SEVEN I.C.s AND ENGAGEMENT IN
APPLICATION-ORIENTED AREAS.
MED TECH IS ANOTHER EXAMPLE OF
RADx-IFICATION.
THE BIG NEWS, WE CAN'T ANNOUNCE
THE HUBS QUITE YET, THEY WILL
HAVE A SOLICITATION WHICH CAN BE
ACCESSED THROUGH THIS URL WHICH
IS NOT LIVE YET BUT THE KEY
THING IS TO SORT OF RAISE YOUR
VISIBILITY HERE BECAUSE THE
SOLICITATION WILL OPEN SEPTEMBER
27, WITH PRE-PROPOSALS DUE
OCTOBER 25.
THIS WILL PROVIDE UP TO 500K PER
YEAR FOR SUPPORT, UP TO FOUR
YEARS, THERE WILL BE UP TO 30
NEW AWARDS PER YEAR.
SEE THIS IS A REALLY POTENTIALLY
HUGELY IMPACTFUL PROGRAM,
CONTACT MIKE WOLFSON WHO HAS
THOUGHT THROUGH ALL OF THE
COMPLEXITY AND STEPS OF THIS
PROGRAM AND INSPIRED OUR
BLUEPRINT COLLEAGUES TO ACTUALLY
ADOPT THIS NEW MODEL, WHICH IS
THE FIRST EXAMPLE ACROSS THE NIH
OF TRANSFERRING ATTRIBUTES OF
RADx TO ESTABLISHED PROGRAMS.
ON THAT TOPIC, WE HAVE A NEW
MECHANISM IN RADx TECH FOR
MATERNAL HEALTH, SO THIS NOW
ADOPTS THE FORMAL NAME OF RADx
TECH.
AS WE'VE BEEN DISCUSSING, IT IS
HOW DO YOU CREATIVELY APPLY
PRINCIPLES OF ACCELERATION AND
SUPPORT THAT CAN HELP FACILITATE
COMMERCIALIZATION AND REGULATORY
AUTHORIZATION, AND RAPID
MANUFACTURING OF TECHNOLOGY, OUR
FIRST ATTEMPT TO DO IT ON A
SCALE DIFFERENT FROM WHAT IS
TYPICALLY DONE WITH TRADITIONAL
GRANTS.
AND WITH AN ENTIRELY NEW
MECHANISTIC STRUCTURE THAT
TAYLOR GILILAN, WE HAVE A
PROBLEM LOOKING AT DISPARITIES
IN MATERNITY CARE DESERTS WHERE
THERE ARE HIGHER RATES OF
MATERNAL MORTALITY AND SEVERE
MATERNAL MORTALITY, THIS IS A
TOPIC WE'VE WORKED ON WITH
NICHD, ACTUALLY FOR SEVERAL
MONTHS, AND THE SOLUTION HERE IS
TO LEVERAGE OUR INNOVATION
FUNNEL PROCESS TO ACCELERATE
INNOVATION AND POINT OF CARE AND
HOME-BASED DIAGNOSTIC AND REMOTE
SENSING TECHNOLOGIES.
SO THERE ARE A NUMBER OF
CONDITIONS THAT THIS WOULD
DIRECTLY APPLY TO, AND LOTS OF
REALLY UNIQUE EXAMPLES OF
TECHNOLOGIES THAT ARE QUITE
ROBUST AND I'LL GET TO SOME OF
THOSE LATER WHEN I PRESENT WHAT
IS IN A SENSE A PREP FOR THIS
PROGRAM, THE NATIONAL TECHNOLOGY
ACCELERATOR CHALLENGE, AND THOSE
AWARDS WHICH WE DID JUST
RECENTLY ANNOUNCED ABOUT A MONTH
AGO.
BUT THESE MAY INCLUDE WEARABLE
DEVICES, AT-HOME DIAGNOSTICS
WITH BIOSPECIMENS,
SMARTPHONE-ENABLED TOOLS, POINT
OF CARE DEVOICES, INTEGRATED
SENSOR TECHNOLOGIES.
AND THE STRUCTURE OF THE PROGRAM
IS REALLY KIND OF REVOLUTIONARY
AND BRILLIANT THANKS TO TAYLOR.
IT'S A MILESTONE-BASED PRIZE
AWARD SYSTEM THAT EMULATES WHAT
WE DO WITH RADx, BUT ALLOWS US
TO USE A PRIZE COMPETITION
STRUCTURE TO MAKE THESE AWARDS
AND KEEP ACCELERATING THE
MOVEMENT OF THE TECHNOLOGIES
THROUGH THE INNOVATION FUNNEL.
I WON'T GO INTO DETAILS OF ALL
OF WHERE THE ARROWS GO AND THE
MEANING BEHIND ALL OF THAT.
TAYLOR, YOU CAN CONTACT HIM FOR
MORE INFORMATION ABOUT THIS.
THE IDEA IS THAT TEAMS OF
INNOVATORS WHO HAVE LOW BARRIER
TO ENTRY FOR THEIR CONCEPTS,
PROTOTYPE TECHNOLOGY
DESCRIPTIONS AND PLANS, THEY ARE
REVIEWED VERY QUICKLY AND MOVE
INTO VARIOUS STAGES OF ANALYSIS
AND POTENTIAL FUNDING.
WHAT I SHOULD MENTION HERE I
DIDN'T POINT THIS OUT, TOTAL
PRIZES HERE ARE $8 MILLION, AND
THIS IS WHERE WE'VE REALLY
LEVERAGED OUR RELATIONSHIP WITH
NICHD, THEY HAVE PROVIDED ALL
THE PRIZE FUNDS AND NIBIB IS
PROVIDING THE EXPERTISE AND ALL
OF THE SURROUNDING STRUCTURES TO
BE ABLE TO EVALUATE THE
TECHNOLOGIES AND SUPPORT THEM
FOR COMMERCIALIZATION AND
REGULATORY AUTHORIZATION.
THE TIMELINE, THE CHALLENGE WAS
JUST ANNOUNCED ON THE 1st OF
SEPTEMBER.
AND WE EXPECT THAT REGISTRATION
AND SUBMISSION PORTAL WILL OPEN
IN A COUPLE DAYS ON THE 15th
OF SEPTEMBER.
WITH A NOVEMBER 1 SUBMISSION
DEADLINE.
THERE ARE A LOT OF LINKS HERE
BUT I THINK YOU CAN SEE THIS ON
OUR WEBSITE.
THERE'S AN INFORMATIONAL WEBINAR
THAT WILL BE LAUNCHED ON THE
22nd AT 2 P.M. EASTERN TIME,
AND I DEFINITELY ENCOURAGE YOU
TO CONTACT TAYLOR TO GET MORE
INFORMATION ABOUT THAT.
THIS HAS BEEN BREWING FOR MANY
MONTHS.
IT'S REALLY AN ENTIRELY NEW
PARADIGM, BECAUSE WE'VE BEEN
ABLE TO LEVERAGE THE PRIZE
STRUCTURE IN ORDER TO CREATE A
RADx TYPE OF PROCESS WITH AN
INNOVATION FUNNEL.
SO TAYLOR HAS BEEN THE LEAD,
ALSO WORKING WITH ANTONELLO
PILEGGI, SUPPORT FROM THE OFFICE
OF RESEARCH IN WOMEN'S HEALTH,
NIDDK, EXPERTS ACROSS THE NIBIB
INCLUDING TODD AND TIFFANI, THE
USUAL SUSPECTS WHO HAVE BEEN
INVOLVED IN THE RADx PROGRAM.
AND IT'S A TRULY
INTERDISCIPLINARY EFFORT WITH
MANY DIFFERENT STAKEHOLDERS.
WHAT'S AMAZING ABOUT THIS IS WE
THINK THIS MODEL IS EXTENDIBLE
TO OTHER MAJOR PROBLEMS THAT
OTHER INSTITUTES AND CENTERS ARE
FACING.
WE'RE HOPING TO BE ABLE TO APPLY
THIS NEXT TO CHALLENGES THAT THE
OFFICE OF AIDS RESEARCH IS
LOOKING AND FACING IN
TECHNOLOGIES THEY NEED, ALSO
WORKING WITH NINR, NHLBI, THERE
ARE A LOT OF INTERESTING GROWTH
OPPORTUNITIES FROM CREATING THIS
FUNDAMENTAL NEW STRUCTURE.
SPEAKING OF PARTNERSHIP WITH
NICHD, WE HAVE AN ACTIVE RFI,
INVITING COMMENTS ON PEDIATRIC
MEDICAL DEVICES FORMING A
PUBLIC/PRIVATE PARTNERSHIP.
MANY OF YOU KNOW WHO HAVE BEEN
INVOLVED IN THIS AREA, THIS IS
EXTREMELY DIFFICULT TO DEVELOP
DEVICES AND GET THEM AUTHORIZED
WORKING WITH THE FDA CAN BE
TOUGH IN THIS PARTICULAR AREA.
SO WE'RE HOPING TO ADVANCE THIS,
WE'RE LOOKING FOR COMMENTS,
ULTIMATELY WE HOPE TO BE ABLE TO
RELEASE SOME MECHANISM THAT
WOULD FACILITATE THAT
DEVELOPMENT.
IN HEAL, HELPING END ADDITION
LONG TERM, YOU'RE FAMILIAR WITH
THAT COMMON FUND PROGRAM.
WHEN THAT WAS FIRST CONCEIVED
THERE WAS NOT THAT MUCH SUPPORT
OR EFFORT DIRECTED TOWARDS OUR
COMMUNITY, OUR TECHNOLOGY
DEVELOPMENT COMMUNITY.
BUT THROUGH THE EFFORTS OF MORIA
BITTMANN AND MIKE WOLFSON AND
OTHERS IN NIBIB WE'VE BEEN ABLE
TO GET "HEAL" TO INVEST IN
TECHNOLOGY DEVELOPMENT AND IN
PARTICULAR THIS IS A NEW
INITIATIVE THAT'S AN R 18,
APPLICATION THAT'S OPEN OCTOBER
14, IT'S DUE NOVEMBER 14, THAT
IS SPECIFICALLY ON DIAGNOSTIC
AND THERAPEUTIC DEVICES, FOR
PAIN OR OPIOID USE DISORDER.
IT'S A REALLY UNUSUAL
OPPORTUNITY, DOESN'T COME AREN'T
THAT OFTEN TO OUR COMMUNITY.
I'M HOPING WE'LL BE ABLE TO
RESPOND TO THIS.
IT'S DESIGNED TO DIRECT
DEVELOPMENT OF NEW TECHNOLOGY
AND APPROACHES WHICH WE THINK
OUR COMMUNITY IS BEST SUITED TO
BE ABLE TO ADDRESS.
THERE ARE NO RESTRICTIONS ON
INVASIVENESS.
SO IT DOESN'T HAVE TO BE
COMPLETELY NON-INVASIVE SYSTEM
EITHER.
THIS IS A NEW -- I JUST GOT
THIS, THIS MORNING.
IT'S A NEW ENTRY INTO THE SLIDE
DECK.
I'M ON THE STEERING COMMITTEE
FOR THIS PARTNERSHIP BETWEEN HHS
AND THE AMERICAN SOCIETY OF
NEPHROLOGY.
AND THEY HAVE A PRIZE WHICH SOME
OF YOU MAY BE FAMILIAR WITH,
KIDNEY-X.
THE TRADITIONAL TRACK IN
KIDNEY-X TO BE SUPPORT
DEVELOPMENT OF BIOARTIFICIAL
KIDNEY PROTOTYPE, AND THEY ARE
FUNDING THESE PRIZES FOR
CONTINUED DEVELOPMENT OF THESE
TYPES OF PROTOTYPES.
ONE OF THE KEY CHALLENGES AND
UNMET NEEDS IS TO BEGIN TO
INTRODUCE SOME OF OUR
BIOMATERIALS COMMUNITY,
SYNTHETIC BIOLOGY COMMUNITY IN A
DIRECTED WAY TOWARDS THIS
PROBLEM.
WE'VE BEEN ABLE TO INSPIRE AN
ENTIRELY NEW TRACK, DEVELOPMENT
OF ENABLING COMPONENTS OR TOOLS,
THESE SPEAK DIRECTLY TO OUR
COMMUNITY.
I HOPE WE'LL HAVE SOME
SUBMISSIONS HERE.
THE TOTAL AMOUNT OF PRIZE
FUNDING UP TO $10.5 MILLION, IT
WILL GO QUICKLY BECAUSE IT'S A
PRIZE CHALLENGE.
AND I HOPE YOU CAN HELP
PUBLICIZE WITH YOUR COLLEAGUES,
PARTICULARLY IN THE BIOMATERIALS
FIELD.
ONE OF THE INTERESTING THINGS
ABOUT TRACK TWO WE'VE BEEN ABLE
TO GET IN IS PREVIOUS EXPERIENCE
WITH KIDNEY RESEARCH
BIOARTIFICIAL KIDNEYS IS NOT
NECESSARILY SO ONE OF THE GOALS
IS TO DRAW NEW PEOPLE IN, INTO
THE COMMUNITY, AND REALLY
INVIGORATE THE ACTIVITIES.
SO I'M GOING TO ANNOUNCE A FEW
RESULTS OF GRANT AND PRIZE
COMPETITIONS NOW THAT I THINK
WE'VE ALL BEEN FOLLOWING AND
LOOKING FORWARD TO SEEING.
YOU'VE HEARD ABOUT OUR R01
FOCUSING ON REDUCING HEALTH
DISPARITIES, SO OUR ENTIRE TEAM
HAS BEEN WORKING REALLY HARD TO
MAKE THESE AWARDS IN FY 22, IN
TIME FOR US TO PRESENT THIS TO
COUNCIL.
IF YOU NOTICE, THE TIME, IT WAS
FIRST DUE FEBRUARY 11, SO HERE
WE ARE ONLY SEVEN MONTHS LATER,
THREE APPLICATIONS HAVE BEEN
FUNDED.
AND I THINK YOU'LL RECOGNIZE THE
TOPICS OF THE AWARDS AS
LONGSTANDING CHALLENGES AND
PROBLEMS IN OUR FIELD.
ONE IS IN BIAS-FREE PULSE
OXIMETRY, SO THEY CAN BE
CORRECTED WORKING WITHOUT
PIGMENTATION AND PROVIDE
ACCURATE READINGS.
MANY PEOPLE POINTED OUT THIS
CRITICAL PROBLEM INCLUDING A
FANTASTIC EDITORIAL PIECE
WRITTEN BY OUR COUNCIL MEMBER
GILDA BARABINO ON THAT TOPIC
FAIRLY RECENTLY.
SECOND ONE IS IN HEP C.
THERE ARE NO POINT OF CARE RAPID
ANTIGEN HEP C DIAGNOSTICS.
THIS WOULD SUPPORT THE
DEVELOPMENT OF THOSE.
THERE ARE SOMEWHERE BETWEEN TWO
AND THREE MILLION PEOPLE IN THE
UNITED STATES WHO HAVE HEP C.
THESE NUMBERS OF COURSE ARE EVEN
LARGER IN THE DEVELOPING WORLD.
THIS WOULD BE A REALLY DRAMATIC
TRANSFORMATION, MANY OF THEM ARE
IN COMMUNITIES WHERE THERE'S
SIGNIFICANT HEALTH DISPARITIES.
WHAT'S QUITE SPECTACULAR IF IT
CAN COME TO PASS AND BE
DEVELOPED IS THAT THERE IS A
CURE FOR HEP C.
SO, THIS CAN COMBINE THE NOTION
OF TESTS AND TREATMENT.
THESE WILL PARTNER TOGETHER AND
I THINK THIS WILL BE A MAJOR
GROWTH AREA IN THE DEVELOPMENT
OF DIAGNOSTICS BOTH WITH HEP C
AND OTHER PATHOGENS.
AND FINALLY, THE THIRD ONE IS IN
THE AREA OF PREVENTING DEATH IN
THE UNDERSERVED MINORITY
POPULATION FROM OPIOID OVERDOSE.
THIS IS A CONTINUOUS REALTIME
NON-INVASIVE CO2 MONITOR THAT
CAN POTENTIALLY IMPACT THAT IN A
VERY SIGNIFICANT WAY.
THOSE ARE THE FIRST THREE
APPLICATIONS FUNDED.
WE'LL KEEP UPDATING YOU ON THE
PROGRESS OF ALL OF THESE AND
WE'RE REALLY EXCITED.
I SHOULD REMIND YOU THIS IS A
PARTNERSHIP WITH NIMHD, MINORITY
HEALTH AND DISPARITIES
INSTITUTES.
THAT WAS AT THE ORIGINAL
CONCEPTION.
WE WANTED TO PARTNER WITH THEM
AND BRING THEM INTO OUR
COMMUNITY.
THEY WILL ALSO BE AWARDING SOME
GRANTS.
WE DON'T KNOW HOW MANY YET BUT
THEY WILL BE COMING IN FISCAL
YEAR 23.
THIS IS JUST A QUICK SNAPSHOT TO
UPDATE YOU ON BRIDGE TO
ARTIFICIAL INTELLIGENCE, THE
COMMON FUND INITIATIVE.
OUR LEADER IS GRACE PENG, AND I
UNDERSTAND THAT A PRESS RELEASE
SHOULD BE COMING OUT TODAY.
I HAVEN'T HAD A CHANCE TO CHECK
THE NIH WEBSITE TO SEE IF THAT
DID COME OUT.
SO, WE ENCOURAGE YOU TO TAKE A
LOOK.
THE ANNOUNCEMENT OF THE WINNERS
WHICH WE'VE ALL BEEN WAITING FOR
IN KEY AREAS FOR ALL OF THESE
NEW DATASET DEVELOPMENT
CHALLENGES SHOULD BE COMING OUT
EITHER TODAY OR VERY SOON
THEREAFTER.
ANOTHER MAJOR PROGRAM WHICH IS A
PRIZE CHALLENGE PROGRAM AND ALL
OF YOU HAVE BEEN FOLLOWING THIS,
I THINK THIS IS KIND OF OUR
SIGNATURE PROGRAM TO SUPPORT
STUDENTS IN TRAINING AND HELP
PEOPLE LATCH ON TO PROMISING AND
MAJOR CHALLENGES FOR THEIR
ENTIRE CAREERS ARE THE DEBUT
AWARDS DESIGNED BY BIOMEDICAL
UNDERGRADUATE TEAMS CHALLENGE
LED BY NEYNEP ERIM AND DAVE GU
TENKUNST.
THIS WE'RE REHAD 73
APPLICATIONS, 456 OPPORTUNITIES
AT 44 UNIVERSITIES, 21 STATES, 3
FOREIGN COUNTRIES, QUITE
EXTENSIVE.
WE ALSO HAVE FOR UNIQUE AWARDS
THAT OTHER INSTITUTES HAVE
SUPPORTED AT $15,000 EACH FROM
THE OFFICE OF AIDS RESEARCH,
FROM NIMHD, NATIONAL CANCER
INSTITUTE, AND NICHD'S NCMRR,
REHABILITATIVE AND ASSISTIVE
TECHNOLOGIES PRIZE.
VENTUREWELL HAS A DESIGNED PRIZE
AN EXCELLENCE PRIZE.
WHAT I'M GOING TO DO NOW IS TELL
YOU ABOUT SOME OF THESE AWARD
WINNERS.
THE FIRST PRIZE IS IN EQUINOX, A
PULSE OXIMETER, ADDRESSING THAT
ISSUE OF DISPARITIES WITH PUTS
OXIMETRY THAT R01 DISPARITY
WINNER JUST RECEIVED.
AND WE HAVE A SECOND PLACE AND
THIRD PLACE AWARD, TO STANFORD
AND TO COLUMBIA, AT-HOME
DIAGNOSTICS FOR STREPTOCOCCUS, A
SIMPLE TOOL THAT QUANTIFIES
CERVICAL STIFFNESS TO DETERMINE
RISK OF PRE-TERM BIRTH.
AN AWARD CEREMONY AT BMES ON
FRIDAY, BETWEEN 3:00 AND 4:30
CENTRAL TIME.
I ENCOURAGE YOU IF YOU'RE THERE
TO COME TO THE AWARDS CEREMONY
BUT I'M GOING TO GIVE A PREVIEW
OF THE VIDEO FROM OUR FIRST
PLACE PRIZE WINNER.
>> HI, WE'RE TEAM EQUINOX AIMING
TO PREVENT HYPOXEMIA IN DARKER
SKINNED PATIENTS.
OXIMETERS ARE CRITICAL
INDICATORS OF HEALTH.
THE NEED FOR THESE DEVICES HAS
BEEN RAPIDLY INCREASED DURING
THE PANDEMIC, HOSPITAL READ
OXIMETERS ARE BIAS FOR PATIENTS
WITH DARKER SKIN TONES.
CONSEQUENTLY MEDICAL PROVIDERS
NEED A MORE ACCURATE METHOD TO
MEASURE LEVELS FOR INDIVIDUALS
WITH DARKER SKIN TONES TO
PREVENT DELAYS IN DIAGNOSIS OF
LOW BLOOD OXYGEN.
LET'S TAKE A LOOK AT HOW PULSE
OXI METER BIAS CAN AFFECT THE
PATIENT.
ONLY AFTER A DELAY OF UP TO 16
HOURS WILL THE PULSE OXIMETER
MEASURE.
>> NOT ONLY ARE THEY INACCURATE
FOR DARKER SKIN TONED PATIENTS,
IT'S IMPACTFUL IN LOW- AND
MIDDLE-INCOME COUNTRIES WITH A
HIGH POPULATION.
THE MOST EFFECTIVE COUNTRIES
DON'T CURRENTLY HAVE RESOURCES
TO DEPLOY THEM.
TAKEN TOGETHER THESE
DISCREPANCIES CREATED A PERFECT
STORM, AFFECT DIAGNOSES
WORLDWIDE.
OUR SOLUTION COMBINES INNOVATION
IN HARDWARE AND SOFTWARE TO
ACCOUNT FOR SKIN TONE DIFFERENCE
AND ADDRESS BIAS FOUND IN
EXISTING PULSE OXIMETER.
>> WE USE SENSOR TO ACCOUNT FOR
DIVERSITY.
>> EQUINOX IS DESIGNED TO BE
COMPETITIVE IN LOW-RESOURCE
SETTINGS WE HOPE TO OPERATE IN.
$25, THE CURRENT DESIGN CAN BE
MADE FOR WELL UNDER THE W.H.O.
RECOMMENDED $40 FOR MARKET
PENETRATION.
IT IS DURABLE AND EASILY
SANITIZED.
PROCESSOR IS FAST, UNDER TEN
SECONDS.
THE ALGORITHM IS ROBUST AND
TAKES INTO ACCOUNT LITERATURE
VALUES USING DATA FROM THOUSANDS
OF PATIENTS.
HAVING COMPLETED THE PROTOTYPING
PHASE WE'RE APPROVED AT JOHNS
HOPKINS, PLAN TO VALIDATE AND
IMPROVE CURRENT ALGORITHM USING
ARTERIAL BLOOD GAS ANALYSIS AND
WILL SEEK FDA APPROVAL TO
DELIVER TO LOW-RESOURCE
SETTINGS.
IT WILL BRING EFFECTIVE PULSE
OXIMETERS TO EVERYONE FOR
EQUITABLE CARE WORLDWIDE.
THANK YOU FOR YOUR TIME.
>> SO, PRETTY IMPRESSIVE THAT
FIRST PLACE WINNER, AND VERY
RESPONSIVE TO AN URGENT NEED
THAT WE ALL RECOGNIZE HAS COME
UP SEVERAL TIMES BUT HASN'T BEEN
ADEQUATELY SOLVED FROM A
COMMERCIALIZATION POINT OF VIEW.
HERE ARE THE OTHER WINNERS OF
THESE PRIZES.
I WON'T GO INTO DETAILS ON
THESE.
YOU CAN SEE THEM, FULLY LISTED
ON OUR WEBSITE.
I ENCOURAGE YOU TO COME TO BMES
TO HEAR PRESENTATIONS FROM EACH
OF THESE GROUPS ON THESE PRIZES.
ANOTHER MAJOR PRIZE CHALLENGE
THAT WE'VE DONE IN PARTNERSHIP
WITH NICHD AND OFFICE FOR
RESEARCH IN WOMEN'S HEALTH IS
NATIONAL TECHNOLOGY ACCELERATOR
CHALLENGE, NTAC LED BY TIFFANI
AND TAYLOR.
WHAT'S INTERESTING ABOUT THIS
ONE, WE WERE HOPING THIS COULD
BE AN APPROACH TO GET PEOPLE
EXCITED AND SORT OF SEE WHAT THE
COMMUNITY IS DOING IN DEVELOPING
TECHNOLOGIES FOR MATERNAL HEALTH
TO FEED INTO THE RADx FUNNEL
PROCESS THAT WOULD FOLLOW ON TO
DEVELOP EVEN MORE TECHNOLOGIES
AND EXPAND OUR IMPACT AND
FOOTPRINT IN THE FIELD.
THAT'S WHAT HAPPENED.
WE HAVE FOUR MAJOR PRIZE
CHALLENGE WINNERS.
THE FIRST ARE IN mHEALTH TOOLS
THAT ARE LOOKING AT HOME-BASED
DIAGNOSTICS OF SURGICAL SITE
INFECTIONS AND ANEMIA.
WEARABLE SENSOR AND POINT OF
CARE SENSORS ARE BASED ON BOTH
ACOUSTIC SENSING, AND OPTICAL
SENSING, WEARABLE CLOTHING,
FLEXIBLE PATCHES, COMBINATION OF
REALLY SOME OF THE BEST
INCLUDING ELECTRIC CHEMICAL
SENSING, SOME BEST APPROACHES IN
OUR FIELD.
AND A VERY EXCITING POINT OF
CARE DIAGNOSTICS THAT'S ACTUALLY
MINIATURIZED BUILDING ON ASIG
WITH APTIMERS THAT CAN DETECT
PREECLAMPSIA, A WIDE RANGE OF
TECHNOLOGIES.
THIS IS OUR PARTNERSHIP WITH
ALSO THE GATES FOUNDATION, AND
AS THESE WINNERS PROGRESS IN
THEIR WORK THEY ARE PARTNERED
WITH GATES AND PROVIDE SOME
ADDITIONAL EITHER FUNDING OR
SUPPORT FOR COMMERCIALIZATION
AND MANUFACTURING.
LET ME ANNOUNCE A COUPLE NEW
PRIZE CHALLENGES AND EVENTS.
WE HAVE ONE THAT WE'VE BEEN
WORKING ON WITH THE RADx RAD
GROUP.
AND THIS IS LED BY QUI DUAN AND
TAYLOR GILLILAND, AND THIS WILL
BE PRIMARILY COMPUTATIONAL,
DEVELOPMENT OF A.I. AND MM
MODELS THAT SEEK TO REUSE
DATABASES IN PARTICULAR, THE N3C
DATABASE WITH ENORMOUS AMOUNT
OF CLINICAL AND PATIENT DATA
FROM COVID PATIENTS OVER AN
EXTENDED PERIOD OF TIME,
ESSENTIALLY THE ENTIRE PANDEMIC.
SO THIS HOPEFULLY WILL STIMULATE
ACTIVITIES AND HELP DRAW OUT
SOME NEW INVESTIGATORS,
OPPORTUNITIES ALSO FOR NEW
INVESTIGATORS TO PARTICIPATE
THIS.
WE HAVE A SYNTHETIC BIOLOGY
CONSORTIUM MEETING COMING UP.
THIS MEETING THEME WILL FOCUS ON
CONTROL THEORY APPROACHES FOR
SYNTHETIC BIOLOGY TOOLS AND
TECHNOLOGIES AND PROCESSES.
THIS IS A FOLLOW-UP FROM
PREVIOUS MEETINGS, AND I
ENCOURAGE YOU TO TAKE A LOOK AT
THE WEBSITE, VIRTUAL INFORMATION
IS -- IT'S A VIRTUAL MEETING,
THE INFORMATION IS AVAILABLE ON
THE SYNTHETIC BIOLOGY WEBSITE.
GRACE PENG HAS BEEN ACTIVE IN
LEADING OUR INTERAGENCY MODELING
AND ANALYSIS GROUP.
YOU'VE HEARD ABOUT THAT.
AND ONE OF THE MAJOR CHALLENGES
THAT TO SOME EXTENT THE BRIDGE
TO A.I. PROGRAM HAS TAKEN ON BUT
STILL IS ONE I THINK THAT WE'RE
DOING TOO MUCH ADMIRING OF AND
NOT ENOUGH ACTION IS IN DIGITAL
TWINS.
AND GRACE HAS BEEN VERY, VERY
ACTIVE IN BRINGING MULTIPLE
INSTITUTES AND CENTERS TOGETHER
AT THE NIH, PARTNERING WITH THE
DEPARTMENT OF ENERGY, NSF AND
DoD, AND NOW HAS SHE AND HER
COLLEAGUES HAVE MANAGED TO BRING
THE NATIONAL ACADEMIES TOGETHER,
TO LAUNCH A STUDY, AN 18-MONTH
ROADMAP STUDY THAT WOULD FOR THE
FIRST TIME INVOLVE MULTIPLE
DOMAIN-SPECIFIC WORKSHOPS, SO
BRINGING DIGITAL TWIN APPROACHES
WHICH ARE VERY WELL ESTABLISHED
IN ENGINEERING DATING BACK TO
THE 50s WITH DEVELOPMENT OF
FINITE ELEMENT AND FINITE
DIFFERENCE APPROACHES, IN THE
DESIGN OF MATERIALS ENGINEERING
PARTICULARLY BUILDING LARGE
STRUCTURES BUT MOVING NOW INTO
SOFTER AREAS WITH LOTS OF
UNCERTAINTIES WHERE OBVIOUSLY
THE LEVEL OF DIFFICULTY IS MUCH
HIGHER AND QUITE DIFFICULT TO
HAVE ANALYTICAL MODELS MUCH LESS
STATISTICAL TO PREDICT BEHAVIOR
BUT THIS WOULD IMPACT EARTH AND
ENVIRONMENTAL SYSTEMS,
BIOMEDICAL AND SPACE, HOT
TOPICS, OPPORTUNITIES FOR
CROSS-FERTILIZATION BETWEEN THE
THREE AREAS, THERE WILL BE
MULTIPLE REPORTS THAT COME FROM
THESE WORKSHOPS.
IF YOU'RE INTERESTED IN ENGAGING
IN THIS, SEE THE WEBSITE AND
PLEASE CONTACT GRACE.
WE'RE HOPING THERE WILL BE SOME
NEW OPPORTUNITIES THAT COME OUT
AS A RESULT.
NOT JUST AS A RESULT OF THIS BUT
THROUGHOUT THE COURSE OF THIS
PROCESS WE'RE HOPING TO BE ABLE
TO ADVANCE NEW APPROACHES IN
DIGITAL TWIN TECHNOLOGIES.
SO I'D LIKE TO TURN TOWARDS
UPDATES IN THE INTRAMURAL
PROGRAM.
AND SOME OF OUR HIRING
HIGHLIGHTS.
ONE IMPORTANT AND EXCITING ONE
IS KAITLIN SADTLER'S RECOGNITION
WITH AN HONORARY DOCTORATE FROM
UNIVERSITY OF MARYLAND,
BALTIMORE COUNTY, UMBC.
AND I JUST THINK THE BEST WAY TO
SHOW YOU ABOUT THIS DOCTORATE
IS TO GIVE YOU A CLIP OF THE
PRESIDENT OF UMBC GIVING THE
AWARD.
>> BY VIRTUE OF THE AUTHORITY
VESTED IN ME BY THE STATE OF
MARYLAND, AND GIVEN TO ME BY THE
CHANCELLOR OF THE UNIVERSITY
SYSTEM OF MARYLAND, AND UPON THE
UNANIMOUS VOTE OF THE BOARD OF
REGENTS, I CONFER UPON YOU THE
DEGREE OF DOCTORAL SCIENCE
TOGETHER WITH ALL THE RIGHTS AND
PRIVILEGES THEREUNTO PERTAINING.
NOW PLEASE JOIN ME IN WELCOMING
DR. KAITLIN SADTLER TO PRESENT
THE SECOND COMMENCEMENT ADDRESS.
[APPLAUSE]
>> I'M A MILLENNIAL, THIS IS
COMING FROM MY PHONE.
SO, FIRST OFF, THANK YOU SO
MUCH, THANK YOU SO MUCH TO THE
UMBC COMMUNITY FOR INVITING ME
TO BE HERE TODAY.
I ALSO WANT TO THANK DR.
CORBETT.
I BELIEVE SHE'S A BIG REASON I'M
STANDING ON THE STAGE TODAY.
SHE SENT A SHORT E-MAIL TO DR.
RIBOWSKI SAYING THERE'S ANOTHER
UMBC ALUM DOING RESEARCH AT THE
NIH, A HUGE CATALYST, THANK YOU
SO MUCH, DR. CORBETT.
[APPLAUSE]
>> WE WANT TO CONGRATULATE THE
CHIEF OF OUR IMMUNOENGINEERING
SECTION FOR THOSE CONTINUING
COUNCIL MEMBERS, YOU'VE SEEN ME
PRESENT HER RESEARCH, I THINK IN
VIRTUALLY EVERY COUNCIL.
SHE LED THE KEY SEROLOGY SURVEY
THAT TIPPED PEOPLE OFF FOR THE
FIRST TIME THAT THE NUMBER OF
COVID CASES IN THE COUNTRY WAS
MAYBE SEVEN OR EIGHT TIMES THE
NUMBER OF COVID CASES THAT THE
CDC HAD BEEN PROJECTING THAT WE
WERE HAVING, VERY IMPACTFUL AND
BEAUTIFUL RESULTS, SHE CONTINUES
TO DO WORK IN THIS AREA.
SO THIS IS SAD NEWS FOR US.
AND YOU MAY HAVE HEARD THIS, ONE
OF OUR SUPERSTAR SENIOR
INVESTIGATORS JUST LEFT NIBIB,
HARI SHROFF IS JOINING JANELIA
FARMS.
SOME OF YOU HAVE HEARD HIS TALKS
IF YOU'RE IN OPTICS AND
PHOTONICS, A SUPERSTAR AND
WIZARD WITH OPTICAL MICROSCOPY,
INVENTED A SUCCESSION OF REALLY
SPECTACULAR APPROACHES, ISPIN,
MSIM, BUT THE BOTTOM LINE
SUPER-RESOLUTION, HIGH-PEAKED,
LOW PHOTOTOXICITY 4D MICROSCOPY,
ADVANCED AN NIH WIDE AIM
FACILITY IN NIBIB THAT WILL STAY
HERE, HARI WILL TAKE HIS
RESEARCH PROGRAM AND MOVE TO
JANELIA BUT THE LEGACY OF HARI'S
WORK WILL STAY AND HE WILL
MAINTAIN TIES WITH NIBIB AND BE
ABLE TO REMAIN APPOINTED AND
CONTINUE TO COLLABORATE WITH
INVESTIGATORS HERE AFTER HIS
MOVE.
HE HAD A REALLY SPECTACULAR
OPPORTUNITY AT JANELIA AND WE
CONGRATULATE HARI ON THAT.
AND WE CONTINUE TO PUSH FORWARD
TO EXPAND DESPITE HARI'S LOSS
OUR INTRAMURAL PROGRAM AND ITS
CAPABILITIES.
ONE OF THOSE IS THE IDEAS LAB.
AND THIS IS NOW OFFICIALLY FULLY
EMBEDDED IN NIBIB'S INTRAMURAL
PROGRAM.
TOM POHIDA LEADS THIS PROGRAM
WITH EIGHT STAFF ENGINEERS.
IT'S INSTRUMENTATION DEVELOPMENT
AND SOLUTIONS, THAT'S THE ORIGIN
OF THE ACRONYM.
MANY ACTIVE PROJECTS AND
COLLABORATIONS ACROSS MOST NIH
INSTITUTES, PROVIDE ENGINEERS
AND COMPUTATION, PROTOTYPING
EXPERTISE, THIS IS THE
EQUIVALENT OF HAVING OUR OWN
SCHOOL OF ENGINEERING
CAPABILITIES, AND IT'S A REAL
FOCAL POINT FOR TRAINING, FOR
STUDENTS WHO COME PARTICULARLY
IN THE SUMMER, AND WILL BE AN
INCREDIBLY IMPORTANT
FOUNDATIONAL PIECE WHEN WE
ESTABLISH OUR BIOMEDICAL
ENGINEERING AND TECHNOLOGY
CENTER.
AGAIN PUSHING TO INCREASE
VISIBILITY AN IMPACT OF OUR
INTRAMURAL RESEARCH PROGRAM,
WE'VE HAD POSTED ON OUR WEBSITE
WHICH IS REQUIRED WHEN WE DO A
REORGANIZATIONAL STRUCTURE THE
NEW APPEARANCE OF OUR INTRAMURAL
RESEARCH PROGRAMS INCLUDING BETA
CENTER AND THIS IS AN NIH-WIDE
CENTER THAT WE BELIEVE WILL BE A
NEW MODEL FOR TECHNOLOGY DRIVEN
TRANSLATIONAL RESEARCH AN
CLINICAL TRANSLATION.
AND WE THINK WITHIN NIH WE CAN
HELP ACCELERATE THE DEVELOPMENT
VALIDATION AND DISSEMINATION OF
TECHNOLOGIES AND PARTNERSHIP
WITH THE EXTRAMURAL COMMUNITY
BOTH WITH TECHNOLOGIES THAT MAY
BE DEVELOPED FROM THE EXTRAMURAL
COMMUNITY BUT ALSO BE AN
OPPORTUNITY TO LEAD THE
EXPANSION OF DIVERSITY, EQUITY,
AND INCLUSION BY ATTRACTING
TRAINEES AND POTENTIALLY NEW
FTEs TO COME INTO THE NIBIB
AND NIH INTRAMURAL RESEARCH
PROGRAM.
THE DIRECTOR OF BETA WILL BE
ALSO NIBIB'S ASSOCIATE DIRECTOR
FOR DIVERSITY, EQUITY,
INCLUSION, AND ACCESSIBILITY,
AND JUST TO -- I THINK EVERYONE
LIKES WORD CHARTS BUT I HOPE I
DON'T CONFUSE YOU WITH THIS ONE,
TO ILLUSTRATE THAT POINT.
THE BETA CENTER DIRECTOR WHO IS
ALSO ASSOCIATE DIRECTOR FOR
DEIA, IS A MAJOR RECRUIT THAT'S
IN PROGRESS AND ALMOST -- WE'RE
ALMOST THERE.
BUT THAT'S ABOUT ALL I CAN SAY
ABOUT IT RIGHT NOW.
IT'S IN PROGRESS.
WE ALSO HAVE A SCIENTIFIC
DIVERSITY OFFICER, ALSO A MAJOR
RECRUIT IN PROCESS JUST ABOUT
WRAPPED UP, I CAN'T ANNOUNCE YET
BUT HOPEFULLY BY NEXT COUNCIL
MEETING OR AT SOME POINT IN
BETWEEN WE'LL BE ABLE TO
ANNOUNCE BOTH.
WE ALSO HAVE OUR EXTRAMURAL
SCIENCE PROGRAM DIRECTOR, DAVE
GEORGE HAS BEEN THE ACTING
DIRECTOR.
THIS RECRUITMENT IS IN PROGRESS.
AND WE NOW HAVE A NEW POSTING
FOR A DIVISION DIRECTOR WHO IS
IN APPLIED SCIENCE AND
TECHNOLOGY WHICH IS OUR
ESSENTIALLY HOUSING ALL
BIOIMAGING ACTIVITIES.
SO I WANTED TO BRING THIS TO
YOUR ATTENTION.
THIS IS POSTING OF AN OPENING,
AND AN OPPORTUNITY POTENTIALLY
FOR COLLEAGUES OF YOURS.
IT WILL BE ON USA JOBS AS WELL
AS NIBIB'S WEBSITE, OPENING ON
THE 21st OF SEPTEMBER, CLOSE
ON THE 30th.
SO THIS IS A DIVISION DIRECTOR
FOR THE ENTIRE DIVISION OF
APPLIED SCIENCE AND TECHNOLOGY
WHICH, AGAIN, IS OUR IMAGING
TECHNOLOGY PROGRAM.
I'D LIKE TO CONCLUDE WITH
PANDEMIC RESPONSE AND UPDATES ON
MIDRC AND RADx.
JILL WILL HELP ME WITH THOSE AS
WELL.
AS I MENTIONED, OUR BIG PANDEMIC
RESPONSE FROM 2020 HAS BEEN IN
THREE MAJOR AREAS, IMAGING AND
A.I., IN VITRO DIAGNOSTICS AND
DIGITAL HEALTH.
IN MIDRC THE PROGRESS IS
NON-LINEAR, A TRIBUTE TO OUR
P.I. FOR THIS PROGRAM, MARYELLEN
GIGER.
WE ANNOUNCED THAT SHE WAS
ROTATING OFF COUNCIL SO A WAY TO
THANK YOU FOR YOUR AMAZING
CONTRIBUTIONS AGAIN AS WE DID
LAST TIME, AND LEAVING A LEGACY
OF GROWTH WITH THIS PROGRAM.
THE OPEN COMMONS RELEASED 10
TERABYTES OF DATA, 62,000
IMAGING STUDIES, AND WHAT'S
SPECTACULAR THERE ARE 90,000
IMAGING STUDIES STILL GOING,
UNDERGOING MIDRC DATA QUALITY
AND HARMONIZATION.
AND THERE ARE NOW MORE THAN 230
USERS FROM MORE THAN 160
INSTITUTIONS, THERE ARE ABOUT 30
PUBLICATIONS THAT HAVE COME OUT.
AND AS WE'VE ALWAYS POINTED OUT
IN UPDATES HERE, THERE'S A
SEQUESTERED DATA COMMONS, 5,000
IMAGING STUDIES THAT ARE
SEQUESTERED TO REALLY HAVE REAL
WORLD ASSESSMENT OF ALGORITHMIC
PERFORMANCE.
AND ONE OF THE KIND OF HOLY
GRAILS OF OUR FIELD, A MAJOR
BARRIER, HAS NOW BEEN OVERCOME.
WE ALL SIT AT THE NIH AND SEE
THESE AMAZING DATABASES.
SO NHLBI HAS BIODATA CATALYST,
CLINICAL DATABASE, PET AL
DATABASE, AT NCATS, MOST OF THE
DATABASES AT THE NIH ARE
CLINICAL DATA, ELECTRONIC HEALTH
RECORDS, PATHOLOGY DATA,
GENOMICS DATA, METABOLOMICS,
EVEN MOBILE HEALTH DATA.
ALL OF US HAVE AN EXTRAORDINARY
AMOUNT OF MOBILE HEALTH DATA IN
THEIR DATABASE, VERY FEW ARE
USING OR CONNECTING TO IMAGING
DATA AN OTHER CLINICAL
DATABASES.
FOR THE FIRST TIME MIDRC HAS
ACHIEVED THE LINKAGE WORKING IN
PARTNERSHIP WITH NHLBI AND
NCATS, BETWEEN THE IMAGING
DATABASES, INTEROPERABILITY WITH
OTHER DATABASES, THOUSANDS OF
SUBJECTS OVERLAP WITHIN ALL OF
THESE DATABASES.
SO, REALLY FOR THE FIRST TIME
SOME OF THE TECHNICAL CHALLENGES
HAVE BEEN ADDRESSED, THE
OPPORTUNITY FOR THE FUTURE IN
MULTIPLE DATABASE LINKAGE REALLY
HAS BEEN CONQUERED.
THIS IS A WONDERFUL
ACCOMPLISHMENT OF THIS PROGRAM,
AND IN THE PROCESS IT'S CREATED
A VISIBILITY FOR THE IMAGING
COMMUNITY AND IMAGING DATABASES,
AS BEING EQUIVALENT AND QUITE
POWERFUL TO ALL OF THE CLINICAL
DATABASE ACCUMULATION THAT'S
GOING ON IN NIH STUDIES.
IN TERMS OF RADx TECH, JUST A
QUICK UPDATE ON NUMBERS.
THROUGH JUNE OF 2022, THE
CUMULATIVE TEST CAPACITY
INCREASE HAS BEEN ALMOST 4
BILLION TESTS.
SO, SINCE WE MET LAST TIME, IN
MAY, WHERE WE WERE UPDATING
THROUGH ROUGHLY FEBRUARY OR
MARCH I THINK AT THE TIME, WE
WERE AT ABOUT 2 BILLION IN TERMS
OF INCREASE IN TESTING CAPACITY.
THAT'S NOW DOUBLED AGAIN.
THE DOMINANT CONTRIBUTORS TO
THOSE ARE OVER THE COUNTER
TESTS, EVERYONE IS USING THOSE
AT HOME, AND THERE STILL
HUNDREDS OF MILLIONS OF TEST AND
TEST PRODUCTS THAT ARE BEING
RELEASED, PRODUCED AND
PURCHASED, BY INDIVIDUALS ALL
AROUND THE COUNTRY IN ORDER TO
DO TESTING AT HOME.
THERE ARE A TOTAL OF 45
EMERGENCY USE AUTHORIZATIONS.
11 ARE FULLY OVER THE COUNTER.
ONE OF THEM IS A PCR APPROACH,
10 ARE ANTIGEN-BASED APPROACHES.
THESE HAVE COME FROM A
COMBINATION OF INNOVATION FUNNEL
AND INDEPENDENT ASSESSMENT
PROGRAM.
THIS IS A HUGE IMPACT BUT WE'RE
NOT SATISFIED.
THERE'S STILL MORE TO DO.
AND I'M GOING TO CALL IN JILL,
MY COLLEAGUE JILL HEEMSKERK, TO
TELL US WHAT MORE THERE IS TO
TACKLE AND CHALLENGES THAT ARE
VERY, VERY IMPORTANT THAT WE
NEED TO TAKE ON.
>> I'M GOING TO TALK ABOUT THE
RADx EFFORTS TO PRODUCE HOME
TESTS ACCESSIBLE FOR USE BY
PEOPLE WITH DISABILITIES.
YOU'LL ALL REMEMBER EARLY THIS
YEAR THAT THE GOVERNMENT BEGAN
DISTRIBUTING FREE COVID TESTS TO
EVERYONE IN THE COUNTRY.
THIS WAS VERY GRATIFYING FOR
RADx, HAVING HELPED GROW THE
TESTING CAPACITY TO THE POINT
WHERE EVERYONE HAD ACCESS TO
RAPID TESTING IN THEIR HOMES.
BUT THE ANNOUNCEMENT STIMULATED
AN URGENT LETTER WRITING
CAMPAIGN FOR DISABILITY
ADVOCATES, PARTICULARLY GROUPS
REPRESENTING THE BLIND.
POINTING OUT THAT THE TESTS WERE
NOT DESIGNED IN A WAY THEY COULD
BE USED INDEPENDENTLY BY PEOPLE
WITH DISABILITIES.
AND THIS WAS A BIG AHA MOMENT
FOR US REALIZING THAT IN OUR MAD
RUSH TO MAKE TESTS AVAILABLE AS
QUICKLY AS POSSIBLE, WE HAD BEEN
NEGLECTING ANY CONSIDERATION OF
PRINCIPLES OF UNIVERSAL DESIGN
AND ACCESSIBILITY AND WE'RE
EAGER TO CORRECT THIS OVERSIGHT
NOW.
SO, THESE LETTERS WENT TO NIH,
NIH DIRECTOR, TO THE DEPARTMENT
OF HEALTH AND HUMAN SERVICES, TO
THE WHITE HOUSE.
AND WE IMMEDIATELY STARTED
THINKING HOW MIGHT WE PROCEED.
AND WE FOUND THAT THERE'S
ACTUALLY VERY LITTLE GROUND WORK
ON WHAT ACCESSIBILITY EVEN MEANS
IN THE HOME TESTING SPACE.
AND SO WE CONVENED A LISTENING
SESSION IN MARCH WITH DISABILITY
ADVOCATES, AND THE SIX
GOVERNMENT AGENCIES THAT HAVE
ACCESSIBILITY IN THEIR MISSION.
AS WELL AS THE LEADERSHIP OF THE
CLINICAL CENTER AND DEPLOYMENT
CORE FOR RADx.
WE FORMED QUITE A GOOD GROUP AND
HAD AMAZING DISCUSSIONS, AND
THIS GROUP HAS STAYED TOGETHER
WITH US THROUGH THE SUBSEQUENT
MONTHS OF DESIGNING AND
IMPLEMENTING THE PROGRAM I'M
GOING TO TELL YOU ABOUT.
IN THIS MEETING, WE HAD THREE
BREAKOUT GROUPS, ONE FOR BLIND
AND LOW VISION, ONE FOR FINE
MOTOR IMPAIRMENT, ONE FOR OLDER
ADULTS CONSIDERING THINGS LIKE
NOT ONLY LOW VISION AND TREMOR
BUT COGNITIVE ISSUES AS WELL.
AND BRUCE, IF YOU GO TO THE NEXT
SLIDE, IT SHOWS SOME OF OUR
LEARNINGS FROM THEIR
DISCUSSIONS.
THEY WERE VERY, VERY REVEALING.
A LOT OF THE ISSUES CENTERED
AROUND THE PACKAGING OF THE
TESTS AND INSTRUCTIONS.
FOR EXAMPLE, THE GOVERNMENT WAS
SENDING OUT MULTIPLE DIFFERENT
KIND OF TESTS AND YOU DID NOT
KNOW WHAT YOU WERE GETTING TILL
YOU OPENED YOUR ENVELOPE.
BUT IF FOR PEOPLE WHO ARE BLIND,
GETTING A BOX IN THE MAIL IS NOT
VERY HELPFUL FOR THEM FINDING
THE INSTRUCTIONS BECAUSE THERE
ARE -- THERE'S NOTHING ON THE
BOX TO SCAN AND TELL THEM WHERE
TO GO TO FIND ACCESSIBLE
INSTRUCTIONS EVEN IF THEY WERE
AVAILABLE.
WE ALL KNOW INSTRUCTIONS ARE
COMPLICATED.
THE PRINT IS SMALL.
THERE'S OFTEN NOT SIMPLE
STEP-BY-STEP DIRECTIONS.
AND PARTICULARLY FOR OLDER
PEOPLE, FEW LANGUAGE OPTIONS,
AND OF COURSE NO BRAILLE AT ALL.
THE TEST PROCEDURE ITSELF WAS
ALSO -- IS ALSO REALLY
COMPLICATED.
TOO MANY STEPS IN THE WORKFLOW,
THE NEED TO COUNT DROPS OF
LIQUID AND SQUEEZE THOSE DROPS
INTO TINY HOLES ON THE DEVICE IS
DIFFICULT NOT ONLY FOR PEOPLE
WITH VISION IMPAIRMENT BUT ALSO
FOR PEOPLE WHO HAVE MOTOR
IMPAIRMENT, TREMOR, WEAKNESS.
LOTS OF SMALL PARTS THAT NEED TO
BE SNAPPED, UNSNAPPED TOGETHER,
AND INSTRUCTIONS THAT ARE VERY
HARD TO ACT ON IF YOU ARE -- IF
YOU DON'T HAVE VISION.
FOR EXAMPLE, THE INSTRUCTION TO
ADD DROPS TO THE HOLE ON THE TOP
WHEN YOU DON'T KNOW WHICH END OF
THE DEVICE IS UP WHEN THERE'S NO
INDICATOR OF THAT, OR THE
INSTRUCTION NOT TO TOUCH THINGS
LIKE THE SWAB OR THE WINDOWS ON
THE DEVICE ARE HUGE IMPEDIMENTS
FOR PEOPLE THAT NEED TO TOUCH TO
PROCEED THROUGH THE WORKFLOW.
CLEARLY FOR PEOPLE WHO ARE
VISION IMPAIRED, THE APPEARANCE
OF LINES ON THE STRIP IS NOT
INTERPRETABLE.
SOME TESTS HAVE READERS THAT
COMMUNICATE WITH SMARTPHONES
SMARTPHONES ARE NOT ACCESSIBLE
TO AS MUCH AS 40% OF THE
DISABILITY COMMUNITY.
THERE'S LOTS TO BE DONE, LOTS OF
CHALLENGES TO ADDRESS.
ON THE NEXT SLIDE, BRUCE, I'M
GOING TO TELL YOU ABOUT ONE ARM
OF OUR RESPONSE WHICH IS THE
FAST TRACK INITIATIVE.
IT WAS AN EFFORT TO THINK
THROUGH WHAT CAN WE DO QUICKLY
TO GET MODIFIED TESTS AVAILABLE
TO THE PUBLIC AS SOON AS
POSSIBLE.
BRUCE WILL TELL YOU NEXT ABOUT A
NEW INITIATIVE TO DEVELOP TESTS
FROM THE GROUND UP WITH
ACCESSIBILITY IN MIND BUT THIS
IDEA WAS TO JUST MAKE
IMPROVEMENTS AS QUICKLY AS WE
CAN.
AND SO THE IDEA HERE IS TO
MODIFY TESTS THAT ARE ALREADY ON
THE MARKET.
WE SET UP A PIPELINE FOR
EVALUATING THE ACCESSIBILITY OF
THE TESTS AND DESIGN IMPROVED
PROTOTYPES.
THIS PIPELINE IS SET UP WITH
CONTRACTORS WHO HAVE EXPERTISE
IN ACCESSIBILITY SPACE, AND IN
FACT WE HAVE DESIGNERS WHO ARE
BLIND, ENGINEERS WHO ARE BLIND
AND HAVE OTHER DISABILITIES TO
HELP THROUGH THIS PROCESS.
WE'RE GOING THROUGH NOW THE
DESIGN OF PROTOTYPES OF MODIFIED
TESTS IN COLLABORATION WITH THE
MANUFACTURERS, THOSE WILL GO FOR
AN EXPERT DESIGN REVIEW AND THE
EXPERT DESIGN REVIEWERS INCLUDE
END USERS FROM THE ADVOCACY
COMMUNITIES THAT WE PARTNERED
WITH EARLIER IN THE YEAR.
AND WE'RE ALSO WORKING OF COURSE
CLOSELY WITH THE FDA WHO WILL
HAVE TO APPROVE ANY
MODIFICATIONS TO THE TESTS
BEFORE MARKETING.
THEY ARE VERY POISED AND EAGER
TO HELP WITH THIS PROCESS.
WE HOPE THAT WE'LL BE GOING INTO
TEST PRODUCTION AS EARLY AS THIS
FALL OR WINTER.
AND WE'VE EXAMINED FOR
ACCESSIBILITY 25 DIFFERENT HOME
TESTS THAT ARE ON THE MARKET.
AND SELECTED 12 OF THOSE THAT
SEEM MOST AMENABLE TO
MODIFICATION.
THE OTHER TWO PARTS OF THIS
EFFORT ARE ON THE RIGHT HAND OF
THE SLIDE HERE, ONE IS THE
DEVELOPMENT OF AN INSTRUCTION
TEMPLATE.
WHEN THESE TESTS WENT THROUGH
THE ACCESSIBILITY EVALUATION,
ABOUT TWO-THIRDS OF THE CONCERNS
RAISED WERE AROUND THE
INSTRUCTIONS.
SO, WHAT WE'RE HOPING TO DO IS
DEVELOP A SORT OF TEMPLATE
APPROACH THAT WE CAN MAKE
AVAILABLE TO ANY MANUFACTURER,
SO THAT WHETHER PEOPLE ARE IN
THE PROGRAM OR NOT A COMPANY IS
IN THE PROGRAM OR NOT, THEY CAN
MODIFY THEIR INSTRUCTIONS TO BE
MORE ACCESSIBLE.
AND THIS WILL INCLUDE
SIMPLIFICATION, LARGER TYPE,
CLEAR LAYOUT, AND LINKAGE TO
WEB-BASED INSTRUCTION TO GO FROM
PAPER INSTRUCTIONS TO WEB-BASED
INSTRUCTIONS EASILY IF THEY NEED
TO.
AND OF COURSE THIS IS A CLOSE
PARTNERSHIP WITH THE FDA WHO HAS
BEEN VERY HELPFUL IN NOT ONLY
ADVISING US BUT PREPARING TO
ACCELERATE THE AUTHORIZATION OF
THE FINAL TEMPLATE.
AND WE'RE WORKING CLOSELY WITH
END USERS TO VALIDATE CHANGES
WE'RE PROPOSING ARE WELCOME.
THE OTHER THING THAT WE'RE DOING
IS A MORE GENERAL BEST PRACTICES
GUIDELINES FOR INDUSTRY.
WE'D LIKE TO MAKE THESE PUBLIC,
SO THAT MOVING FORWARD
MANUFACTURERS WILL HAVE A
RESOURCE TO LOOK AT TO TELL THEM
WHAT ARE PRINCIPLES THEY CAN
APPLY TO MAKE THEIR TESTS MORE
ACCESSIBLE.
AND WE'RE DESIGNING THIS TO BE
BROADLY APPLICABLE SO HOPEFULLY
IT WILL APPLY NOT JUST TO COVID
TESTS BUT LOTS OF HOME
DIAGNOSTIC AND HOME MEDICAL
DEVICES.
WE'RE PARTNERING WITH FDA AND
U.S. ACCESS BOARD, THE AGENCY
RESPONSIBLE FOR THE STANDARDS
RECOMMENDATIONS COMING UNDER THE
AMERICANS WITH DISABILITIES ACT.
SO ALL OF THIS IS TO GET
IMPROVEMENTS OUT AS QUICKLY AS
POSSIBLE.
NONE OF THIS WILL LIKELY BE
PERFECT BUT WE HOPE THAT WE WILL
MAKE SOME STRIDES IN THE
DIRECTION OF ACCESSIBILITY
RELATIVELY QUICKLY BY TAKING
THIS APPROACH.
BRUCE, I'LL TURN IT BACK TO YOU
TO TELL THEM ABOUT OUR NEW
INITIATIVES.
>> AS JILL SAID, WE'RE NOW --
SOME OF YOU MAY HAVE SEEN, JUST
RELEASED A FUNDING ANNOUNCEMENT,
AND THIS MAY BE I GUESS PERHAPS
OUR LAST BIG FUNDING
ANNOUNCEMENT THAT WE DO,
ALTHOUGH WE'RE HOPING WE'LL BE
ABLE TO CONTINUE RADx TYPES OF
FUNDING PROGRAMS BUT THIS IS UP
TO $300 MILLION, AND THE ORIGIN
OF FUNDS, AGAIN, ARE IN THE
SUPPLEMENTAL APPROPRIATIONS THAT
WE WERE ABLE TO RECEIVE BUT
BASED ON WHERE WE ARE CURRENTLY
IN THE PANDEMIC AND AS JILL
POINTED OUT THE HUGE CHALLENGE
FOR HAVING ACCESSIBLE TEST
TECHNOLOGIES CLEARLY MANY
WELL-ESTABLISHED DESIGNS THAT
HAVE BEEN IN OPERATION FOR
SEVERAL DECADES WERE EASIER TO
DEVELOP QUICKLY AND DISSEMINATE
WIDELY.
AND I THINK CERTAINLY NONE OF US
EXPECTED AT THE BEGINNING OF THE
PANDEMIC THAT IN FEBRUARY OF
2022 THERE WOULD BE A BILLION
TESTS THAT WERE DISTRIBUTED OVER
THE COUNTER, AND THAT OUR EFFORT
WOULD BE DIRECTLY IMPACTFUL IN
THIS KIND OF DEVELOPMENT AND
PARADIGM SHIFT IN TESTING
TECHNOLOGIES, BUT THAT IS OUT
THERE NOW, SO AS WE STEP BACK
AND TAKE A LOOK AT WHAT ARE THE
MAJOR CHALLENGES, NUMBER ONE,
IT'S REALLY TO RAISE THE GAME ON
ACCESSIBILITY.
AND SO WITHIN THIS INNOVATION
FUNNEL THERE ARE TWO INNOVATION
FUNNELS WE RECENTLY ANNOUNCED.
THE FIRST IS IN ACCESSIBLE
TECHNOLOGY DESIGNED FOR
INDEPENDENT USE BY PEOPLE WITH
DISABILITIES.
AND ALL THE KEY CHALLENGES, JILL
HAS SUMMARIZED BEAUTIFULLY WHAT
WE'D LIKE TO SEE WITH THESE THAT
THE SUCCESSFUL ONES WILL BE
EASIER TO USE BUT WE'RE NOT
NECESSARILY REQUESTING WITHIN
THE DESIGN PERIOD FOR THE
PERFORMANCE TO BE SUBSTANTIALLY
BETTER AT INVESTING CLASS
CURRENT TECHNOLOGIES ALTHOUGH AS
YOU'LL SEE IN THE NEXT CHALLENGE
THAT'S WHAT WE'RE AFTER.
AND SO SUCCESSFUL PLATFORMS NEED
TO ACHIEVE SOME REGULAR STANDARD
REGULATORY EXPERIENCE, THIS IS
SOMETHING THAT WE'RE HOPING FOR
THE LONG TERM TO STIMULATE A
MAJOR CHANGE IN THE FIELD.
AND THE COMPANION PIECE TO THIS
IS TRYING TO DRIVE FORWARD NEXT
GEN -- TRULY NEXT GENERATION
TECHNOLOGIES WITH INNOVATIONS
THAT SIGNIFICANTLY IMPROVE THE
CLINICAL AND TECHNICAL
PERFORMANCE.
BUT THESE CAN'T BE INTRODUCED
WITHOUT INSPIRATION AND
ATTENTION TO CHALLENGE NUMBER
ONE, WHICH IS TO HAVE UNIVERSAL
DESIGN FEATURES AND
ACCESSIBILITY FOR ALL.
WE'D LIKE TO SEE THESE
TECHNOLOGIES ALSO INCORPORATE
SOME OF OUR DIGITAL HEALTH
REPORTING STANDARDS, I THINK ALL
OF YOU HAVE FOLLOWED THE GAP IN
TERMS OF INFORMATION AND
REPORTABILITY OF
OVER-THE-COUNTER TESTS.
THE RADx MOBILE APPLICATION
REPORTING STANDARD SYSTEM, MARS,
ADDRESSED THAT GAP.
AND WE'D LIKE TO SEE NEW
TECHNOLOGIES BUILT IN AT THE
FOUNDATION AND REALLY PROVIDE
KIND OF THE NEXT GENERATION OF
TECHNOLOGIC PERFORMANCE AND
COMMUNICATION FOR PERSONAL
HEALTH AS WELL AS PUBLIC HEALTH.
WE'D LIKE TO SEE THESE
TECHNOLOGIES ELIMINATE THE NEED
OR REDUCE THE NEED FOR SERIAL
TESTING, AGAIN I PRESENTED AT
THE LAST COUNCIL MEETING, YOU
MAY HAVE FOLLOWED THIS.
RAPID ANTIGEN TESTS ARE TERRIFIC
IF YOU HAVE A LOT OF VIRUS IN
YOU BUT IF YOU'RE STILL ON AN
ASCENDING PORTION OF YOUR
INFECTION YOU MAY HAVE A
NEGATIVE TEST.
IT'S IMPORTANT THAT YOU HAVE TWO
TESTS THAT ARE SEPARATED BY 48
HOURS IF YOU'RE SYMPTOMATIC IN
ORDER TO HAVE THE HIGHEST
PROBABILITY OF GETTING A
POSITIVE RESULT.
SO, WE'D LIKE TO SEE THE LIMITS
OF DETECTION EVEN WAY BETTER BY
AT LEAST AN ORDER OF MAGNITUDE,
IF NOT MORE.
AND THE EASE OF USE BE
SUBSTANTIALLY IMPROVED WITH THE
TWO FUNDING ANNOUNCEMENTS, GOING
LIVE ON THE 20th OF SEPTEMBER,
AND YOU CAN TAKE A LOOK AT THIS.
IT'S ON OUR BANNER PAGE ON OUR
WEBSITE.
AND FINALLY JUST THE LAST PIECE
OF NEWS AND UPDATE, I THINK
EVERYONE'S BEEN FOLLOWING AS WE
HAVE BEEN DISCUSSING IN ALL OF
OUR COUNCIL MEETINGS THE NEED TO
LEVERAGE ALL THE WORK THAT WE'VE
DONE IN COVID TESTING TO OTHER
PATHOGENS AND DISEASES.
AND ONE OF THE FIRST MAJOR
CHALLENGES THAT'S COME UP IS FOR
MONKEYPOX, AND PROBABLY YOU'VE
ALL FOLLOWED THE FRUSTRATING
ROLLOUT OF THE TESTING
TECHNOLOGIES.
SEEMED LIKE DEJA VU ALL OVER
AGAIN WITH ONLY A FEW
LABORATORIES DOING THESE, LONG
TURNAROUND ITEMS, MULTI-STEP
COMPLICATED TESTS, AS WE
PARTICIPATED IN MANY EVENTS
ACROSS THE GOVERNMENT TO DISCUSS
THIS UNFORTUNATELY WE WERE
CONSTRAINED FROM BEING ABLE TO
INVEST COVID FUNDS FOR MONKEYPOX
TEST DEVELOPMENT WHICH WE FELT
LIKE WE COULD IMMEDIATELY
LEVERAGE ALL THE ACTIVITIES FROM
COVID, BUT WE'VE BEEN ABLE TO
GET A MODEST AMOUNT OF NEW
RESOURCES FROM THE OFFICE OF THE
DIRECTOR AT THE NIH, TO INVEST
IN OUR ITA, OUR PARTNERSHIP WITH
FDA AND CAN YOU SEE THIS ON OUR
WEBSITE, THIS IS A NEW
OPPORTUNITY FOR ACCELERATING
REGULATORY PRICE IN POINT OF
CARE NUCLEIC ACID TEST, RAPID
ANTIGEN AND AT-HOME TESTING
KITS, NOT AUTHORIZED IN THE
UNITED STATES FOR MONKEYPOX.
THERE'S A BIG GAP MOVING TESTING
TECHNOLOGIES INTO THESE DOMAINS
WHEN NEW PATHOGENS COME UP.
WE HOPE WE CAN FILL THAT GAP
FIRST WITH MONKEYPOX AND FOR
OTHERS THAT WILL BE EMERGING.
SO, WITH THAT, I CAN STOP
SHARING AND I THINK THAT
SUMMARIZES, WE HIT YOU WITH A
LOT OF STUFF, PROBABLY AND
OVERWHELMING AMOUNT.
BUT WE CAN PIVOT TO QUESTIONS.
>> THANK YOU, BRUCE AND JILL.
QUESTIONS AND COMMENTS FROM THE
COUNCIL MEMBERS?
WE'D LOVE TO HEAR YOUR THOUGHTS.
I SEE MARYELLEN.
>> HI.
THANK YOU, BRUCE.
AS ALWAYS, AMAZING AMOUNT OF
WORK COMING OUT OF NIBIB.
FIRST I'M GOING TO MISS THESE
MEETINGS.
I'VE LEARNED A LOT AT ALL OF
THEM.
SO THANK YOU ALL FOR HAVING ME
HERE FOR THESE YEARS.
AND THEN I ALSO WANT TO THANK
YOU PUBLICLY FOR ALL YOUR
SUPPORT, EVERYONE AT NIBIB, OF
MIDRC.
IT'S A TEAM EFFORT.
IT'S 100 MORE PEOPLE BESIDES ME.
ALSO, I WANT TO POINT OUT THAT
THAT LISTENING TO NEWER
CHALLENGES THAT I HOPE IMAGING
CAN SNEAK AND GET IN THOSE TOO
AND I'LL BE HERE PUSHING ON THE
SIDELINES FOR THAT.
I THINK THE MULTIOMICS IMAGING
WITH OTHER CHARACTERISTICS, EHI
AND OTHERS ARE THE WAY TO GO.
GREAT THEY ARE STARTED.
ALSO TO JILL AND YOU, I WANT TO
TELL YOU, I APPRECIATE HOW
YOU'RE INCORPORATING THE USER
FEEDBACK INTO -- YES, YOU
SUCCESSFULLY DEVELOPED HOME
TESTS BUT NOW YOU'RE EVEN GOING
FURTHER WITH THEM AND
INCORPORATING EVERYONE'S
FEEDBACK.
I'VE BEEN A USER OF THOSE, SO I
APPRECIATE THAT TOO BUT ALSO
SCIENCE.
ALSO TO POINT OUT HOW RAPIDLY
YOU'VE GONE TO STANDARDIZING.
YOU KNOW, EVERYTHING WE DO, WE
NEED TO STANDARDIZE TO MAKE IT
UNIVERSAL.
I APPRECIATE THAT.
THAT'S ALL THE COMMENTS I HAD.
THANK YOU.
>> THANKS, MARYELLEN.
ALL OF THIS IS IS DESIGNED TO
PARTNER WITH ALL OF YOU.
YOU'RE THE LEADERS AND TO GIVE
MORE FEEDBACK ON HOW TO TAKE THE
BASIC PRINCIPLES AND IMPACT IN
OTHER AREAS AND LOOK FORWARD TO
WORKING WITH YOU ON THAT,
PARTICULARLY IMAGING.
BUT IT WAS ASTOUNDING TO BE IN
THE LISTENING SESSIONS IN ABOUT
30 SECONDS OF BEING IN ONE OF
THE LITTLE SMALLER WORKING
GROUPS IT HIT ME THESE TESTS ARE
ACTUALLY PRETTY HARD TO DO.
SOME HAVE SOMETHING LIKE 20
STEPS, PULL THE DIRECTIONS OUT,
DO THIS AND THIS AND THIS.
IT'S CLEAR WE CAN DO BETTER.
OUR COMMUNITY IS THE ONE TO MAKE
THAT HAPPEN.
>> I SEE KATHY AND RANU PLEASE.
>> YES, FIRST VERY IMPRESSIVE,
THE AMOUNT OF WORK THAT'S
HAPPENING.
ALSO, THE COLLABORATIONS ACROSS
AGENCIES, I THINK IT'S
IMPRESSIVE, PARTICULARLY
EXCITING CONTINUOUS HOW YOU
LEVERAGED INNOVATION FUNNEL
CONCEPT, ABLE TO APPLY THAT TO
NO CHALLENGES AS THEY COME ALONG
AND SUCCEED THERE.
I GUESS, A, THAT'S IMPRESSIVE,
I'M EXCITED ABOUT THAT.
B, I'M WONDERING IF THERE'S A
WAY OR WHAT OPPORTUNITIES THERE
MIGHT BE TO SHOW THE PUBLIC HOW
SUCCESSFUL IT'S BEEN AND THE
VISION OF MOVING FOR QUICKLY,
FROM DEVELOPMENT INTO THE CLINIC
AND APPLICATION.
>> THAT'S A GOOD POINT.
I THINK I WOULD TURN A LOT OF
THAT BACK ON TO YOU, YOU GUYS,
TO HELP REPEAT THIS STORY.
AND I MEAN WE'RE DOING THAT AS
BEST AS WE CAN.
I THINK WHAT'S REALLY
INTERESTING, WE'VE BEEN PLANNING
FOR SUPPLEMENTS TO GO AWAY,
$1.7 BILLION THAT SHOULD
DISAPPEAR, IT'S POSSIBLE IN ALL
OF THIS WORK WE'VE BECOME SORT
OF LIKE THE SWAT TEAM ACROSS
GOVERNMENT.
YOU KNOW, THE GO-TO GROUP THAT
CAN SOLVE PROBLEMS NOT PLANNED,
THE ONES THAT KEEP COMING UP.
SO, WE MAY GET MORE SUPPLEMENTAL
FUNDING IN THE FUTURE TO
ACTUALLY CONTINUE IN THAT ROLE.
WE'VE REVEALED A HUGE GAP IN THE
CAPABILITY OF THE COUNTRY TO
DE-RISK THINGS WHEN THERE'S NOT
FULLY A COMMERCIAL MARKET FOR IT
WHICH IS JUST -- THAT'S JUST
WHAT OUR COMMUNITY DOES.
WE KNOW THIS.
THIS IS JUST OUR PEOPLE DOING
WHAT WE DO.
SO, BUT THE $8 MILLION FUNNEL
WITH NICHD IS KIND OF OUR WORST
CASE SCENARIO PLANNING FOR THE
FUTURE WHERE WE HAVE NO
SUPPLEMENTAL FUNDS, CAN WE FORM
PARTNERSHIPS WITH OTHER
INSTITUTES THAT, REMEMBER, OUR
BUDGET IS I MEAN JUST BY
COMPARISON, NIAID IS $6 BILLION
PER YEAR SO THEY SHOULD BE ABLE
TO FIND $6 MILLION TO WORK ON
PROBLEMS THAT THEY ARE
INTERESTED IN.
SO WE'RE KIND OF LIKE THE LEAN
START-UP, YOU KNOW, LOOKING FOR
BUSINESS DEVELOPMENT
OPPORTUNITIES WITH OTHER
INSTITUTES AND CENTERS AND WE
WELCOME YOUR PERSONAL -- YOU
KNOW, THE AREAS YOU THINK ARE
AREAS OF NEED FOR US TO
POTENTIALLY DEPLOY THIS AND
YOU'RE ALL FUNDED BY OTHER
INSTITUTES AND CENTERS.
AND, YOU KNOW, THE WAY THIS
GROWS IS WHEN THE COMMUNITY
SAYS, HEY, WE NEED TO DRIVE AN
INNOVATION FUNNEL IN THIS
PARTICULAR AREA, AND SEE IF WE
CAN DE-RISK AND ACCELERATE AND
MOVE THINGS.
NICHD, MY LAB HAPPENS TO BE IN
NICHD.
WE HAVE REALLY GREAT
COLLABORATIVE RELATIONSHIPS WITH
DIANA BIANCHI, AND THEY HAVE
GRAVITATED DIRECTLY, ALLISONER
ALISON CERNICH IS DEPUTY
DIRECTOR, TECHNOLOGY SAVVY, AND
SO THIS WAS EASY FOR US TO DO.
IT'S TAKEN SOME TIME TO GET IT
LAUNCHED.
BUT WE HOPE TO JUST REPRODUCE
THAT, EVEN WITHOUT ANY
SUBSTANTIAL ADDITIONAL
SUPPLEMENTAL FUNDING.
>> THANK YOU.
I LOVE THE ZOOM FEATURES WITH
THE HANDS ORIENTING THE
PICTURES.
IT'S REAL EASY, RANU AND
JENNIFER.
>> BRUCE AND JILL, AGAIN,
CONGRATULATIONS FOR SUCH A
FANTASTIC JOB.
I'M REMINDED OF EARLIER ON WHEN
THE COUNCIL TALKED ABOUT HOW CAN
RADx BE -- HOW CAN THAT MODEL
BE MADE BETTER.
IT'S REALLY, REALLY GRATIFYING
TO SEE HOW YOU'VE BEEN ABLE TO
TAKE THAT AND PUT IT INTO
DIFFERENT PARTS, MANY PARTS.
THE LAST PART THAT JILL
MENTIONED, ACCESSIBILITY, IT
WOULD BE GREAT TO SEE THAT WHEN
WE'RE MAKING CAUSE FOR
TECHNOLOGY, ET CETERA, UP FRONT
WE TRY TO EMBED THAT INTO OUR
PROGRAM ITSELF SO THAT AT LEAST
PEOPLE ARE AWARE WHEN THEY ARE
MAKING THE TECHNOLOGY RIGHT FROM
THE GET-GO AND THAT WE DON'T END
UP WITH THIS COVID TEST ALL OF
US HAVE STRUGGLED WITH, MORE
THAN OTHERS, TO DO.
THE OTHER THING I WANTED TO ALSO
SEE IS THAT DIGITAL TWIN PROGRAM
THAT THE REPORTS ARE COMING OUT
FOR.
HOW COULD NIBIB BE PRO-ACTIVE
AND THINK ABOUT THAT ASPECT
BEING INTEGRATED INTO OUR EFFORT
AT SUPPORTING THE FUTURE FUNDING
MECHANISM BECAUSE OBVIOUSLY
THOSE REPORTS ARE COMING, THE
OPPORTUNITY WILL FOLLOW, ONE WAY
OR ANOTHER.
STRATEGICALLY THINKING ABOUT
THAT, THAT WOULD BE NICE.
GREAT JOB, A LOT HERE, SO
FANTASTIC.
>> JILL, DO YOU WANT TO SAY
SOMETHING ABOUT THE
TRANSFERABILITY OF THESE DESIGN
PRINCIPLES?
AND I'LL SAY SOMETHING ABOUT
DIGITAL TWINS?
>> SURE.
THANK YOU, RANU.
THAT'S EXACTLY OUR RESOLVE, TO
BUILD ACCESSIBILITY IN AT THE
GROUND FLOOR WITH EVERYTHING WE
DO.
AND WE'VE ALREADY INCORPORATED
THAT AS A KEY ASPECT OF HIGHER
PERFORMANCE TEST SOLICITATION
THAT WE JUST PUT OUT.
WE WANT COMPANIES TO THINK ABOUT
THIS RIGHT FROM THE BEGINNING
BECAUSE OUR EXPERIENCE TELLS
FUSS WE GO TO A COMPANY THAT'S
HAPPILY MANUFACTURING A TEST
THEY DON'T NECESSARILY WELCOME
THE IDEA, SOME DO, BUT THEY
DON'T ALL WELCOME THE IDEA OF
MAKING A CHANGE FOR THE SAKE OF
ACCESSIBILITY.
THIGH HE CAN YOU'RE RIGHT WE
HAVE TO JUST REALLY NORMALIZE
THAT APPROACH, AND THAT'S PART
OF WHY WE WANT TO MAKE THESE
MATERIALS AND TEMPLATES AND
GUIDELINES PUBLIC AND ACCESSIBLE
SO COMPANIES KNOW WHAT WE'RE
ASKING FOR.
AND I THINK THAT'S ONE OF THE
BEST THINGS THAT WILL COME OUT
OF THIS INITIAL FAST TRACK
EFFORT IS ALL THE LESSONS WE'RE
LEARNING AND WHAT WE'RE FINDING
OUT FROM THE ACCESSIBLE DESIGN
HOUSES, HOW TO THINK THAT WAY.
IF WE CAN CAPTURE THAT AND SHARE
IT, WE'VE DONE SOMETHING GOOD I
THINK.
THANK YOU.
>> YEAH, A QUICK COMMENT ABOUT
DIGITAL TWINS, RANU, I DON'T
WANT TO WAIT UNTIL THE REPORT
COMMENTS OUT.
GRACE HAS BEEN A HUGE LEADER AND
ADVOCATE IN THIS, AND THE BRIDGE
TO A.I. INITIATIVE WE WERE
HOPING THAT MORE DIGITAL TWIN
CONCEPTS WOULD COME THROUGH.
I DON'T KNOW IF AWARDS HAVE BEEN
ANNOUNCED YET BUT SUPPOSEDLY
THEY ARE COMING THIS MORNING.
HAS ANYBODY HAD A CHANCE TO LOOK
ONLINE TO SEE IF THEY POPPED UP?
>> YEAH, THEY ARE UP.
>> THEY ARE UP?
WE NEED TO DO THAT NOW.
I MEAN, WE'RE IMPATIENT.
WE'VE SEEN HOW THIS CAN
DRAMATICALLY IMPACT EVEN IMAGING
TECHNOLOGY DEVELOPMENT, FOR
EXAMPLE WHEN YOU LOOK AT HUGE
CLINICAL STUDIES DONE COMPARING
ONE INSTRUMENT TO THE OTHER, AND
THE ONE THAT COMES TO MIND IS
DIGITAL SYNTHESIS VERSUS DIGITAL
MAMMOGRAPHY, HUNDREDS OF
MILLIONS OF DOLLARS TO COMPARE
THE TWO, SOMETHING THAT CAN BE
FULLY DIGITALLY TWINNED, AN FDA
STUDY, COULD YOU IMMEDIATELY
GRASP DIFFERENCES IN A
QUANTITATIVE SENSE AND THAT
LITERALLY COULD HAVE SAVED,
GOODNESS, I DON'T WANT TO SAY
THE NUMBER.
BUT THERE IS ENORMOUS POTENTIAL
AND OPPORTUNITY THERE, NOT JUST
IN THE TECHNOLOGY BUT IN
BUILDING IN PREDICTIVE MODELS
FOR INTEGRATED PHYSIOLOGIC SAYS
ITEMS -- SYSTEMS.
EVERYONE WILL HAVE A DIGITAL
TWIN IN THE FUTURE BUT HE DON'T
WANT TO WAIT THAT LONG.
I TURN IT BACK TO YOU.
SEND IN SOME CONCEPTS AND
SUGGESTIONS IN THAT AREA AND
CONNECT WITH GRACE.
>> SAM AND JENNIFER?
>> WHAT I WAS TRYING TO SAY WAS
ADDRESSED.
THANK YOU, BRUCE, AN NIBIB FOR
WHAT YOU'RE DOING.
DELIGHTED TO SEE HOW YOU RESPOND
TO REQUESTS AND DEMANDS AND
OBSERVATIONS, FEEDBACK.
ALSO IN THE AREA OF HEALTH
DISPARITY, I WANT TO THANK YOU
SO MUCH FOR THE WAY YOU'VE
SPONSORED THE SITE PROJECTS TO
ADDRESS REALLY BIG PROBLEMS.
I THINK NIBIB'S WELL POSITIONED
TO ADDRESS THE ISSUE OF HEALTH
DISPARITIES, IN OPTICAL, WE KNOW
WHAT THAT MEANS.
WHEN WE DO CALIBRATIONS MOST
PEOPLE DO NOT CONSIDER VARIOUS
EFFECTS OF MELANIN IN RESPONSE
RATE OF OUR TECHNOLOGY.
SO NOW THAT WE'RE ADDRESSING
THOSE ISSUES, IT'S VERY
IMPORTANT.
I ALSO WANT TO TOUCH THE ISSUE
WITH DATABASE THAT WE'RE
GENERATING IN GENERAL.
WE KNOW A LOT OF FUNDERS,
MEDICAL SENDERS, RANGE OF
NORMALCY DEVELOPED MANY YEARS
AGO AND WE DEVOLVED A LOT.
SOME OF THEM ARE NOT REALLY AS
RELEVANT AS THEY USED TO BE.
IS IT TIME FOR NIBIB TO START
LOOKING INTO THAT AND SEEING HOW
WE CAN REDEFINE WHAT IS NORMAL
RANGE IN THE HEALTH CARE SPACE
RIGHT NOW?
>> I THINK THAT THAT IS ACTUALLY
TOP OF MIND FOR ALL OF NIH.
AND THAT IS ONE OF THE KEY
CONCEPTUAL FRAMEWORKS BEHIND
BRIDGE TO A.I. WHICH IS THAT
DATABASES NEED TO BE
REPRESENTATIVE AND ETHICAL
DATABASES THAT ARE NOT THE --
THAT DON'T HAVE BUILT-IN
INTRINSIC BIAS, THAT'S AT THE
ABSOLUTE CENTER, THE CORE OF
MIDRC.
AND THAT'S, YOU KNOW, FROM THE
VERY FOUNDATION THE ORIGIN OF
THINKING.
WHAT'S SO BEAUTIFUL ABOUT MIDRC
IS IT'S ACTUALLY GOT THE RANGE
OF EXPERTISE FROM THE PHYSICISTS
WHO CARE ABOUT THE ORIGIN OF
EVERY VOXEL TO THE PHYSICIANS
WHO REALLY WANT TO MAKE
DIAGNOSIS AND IMPROVE THE
OUTCOME FOR PATIENT.
AND I THINK THAT'S THE KIND
OF -- FROM WHAT I FOUND ACROSS
THE NIH, PEOPLE MAY HAVE THE
AMBITION OF HAVING FAIR
DATABASES, REPRESENTATIVE
DATABASES, AND REALLY GOOD A.I.
BUT THEY DON'T ALWAYS HAVE THE
TECHNICAL KNOW-HOW OF HOW TO
REALLY ENSURE THAT THAT IS THE
CASE.
AND THEN DEVELOP THE RIGHT
TOOLS.
WE INSERTED OURSELVES IN THIS
RADX-UP COMPETITION, WHICH
PROPOSED TO DO AI APPROACHES IN
COVID DIAGNOSTICS.
FORTUNATELY, I WAS INVOLVED IN
THAT, AND OTHERS WERE, WE WERE
ABLE TO HELP SHAPE DIRECTIONS SO
THEY BUILT THOSE CONSIDERATIONS
OF THE TECHNICAL SMARTS, YOU
KNOW, AT THE FOUNDATION.
SO THE SPIRIT OF WHAT MARYELLEN
AND COLLEAGUES ARE DOING IN
MIDRC IS WHAT WE NEED TO EXPAND
AND ITS QUITE REPRESENTATIVE OF
THINGS THAT NEED TO GO ON ACROSS
THE NIH.
ABSOLUTELY.
AND YOU GUYS NEED TO KEEP
TELLING THAT STORY BECAUSE IT'S
A VERY, VERY IMPORTANT ONE TO
REPEAT.
>> THANK YOU, SAM.
JENNIFER?
>> THANK YOU FOR THAT EXCELLENT
PRESENTATION, ALL THE AMAZING
WORK.
SO, NOW THAT RADx HAS SHOWN
ITSELF TO BE A GREAT MECHANISM
AND COVID AND BEING EXTENDED TO
OTHER SPECIAL PROJECTS DO YOU
SEE THAT TYPE OF MODEL
PERMEATING ITS WAY INTO A
PERMANENT PART OF THE NIBIB
FUNDING PROFILE?
I LOVE THE IDEA OF FUNNELING
THINGS DOWN AND GIVING WHAT'S
ESSENTIALLY LIKE SEED GRANTS TO
PEOPLE WHO HAVE GOOD IDEAS THAT
DON'T MEET THE LEVEL OF
PRELIMINARY DATA YOU NEED TO BE
COMPETITIVE FOR AN R01.
>> JENNIFER, ABSOLUTELY.
YEAH, AND THAT WHOLE STRUCTURE,
YOU SHOULD TALK TO TAYLOR
BECAUSE HE'S COME UP WITH THE
PROCESS, THE INNOVATION IS IN
THE PROCESS, HOW TO USE MULTIPLE
STAGED AWARDS TO BE ABLE TO
REALLY RECAPITULATE THE WHOLE
FUNNEL.
A LOT OF THIS AS YOU ALL KNOW
COMES DOWN TO THE DETAILS OF HOW
YOU GET PEOPLE MONEY AND HOW
FAST YOU CAN DO THAT.
AND ALSO THE SORT OF MECHANISMS
THAT YOU USE TO EVALUATE THE
VALUE OF A CONCEPT AS IT
CONTINUES TO PROGRESS OVER ITS
ARC OF DEVELOPMENT.
WE HOPE TO COPY/PASTE THAT AND
EVERYONE I TALK TO AT ALL THE
OTHER INSTITUTES, WHENEVER I
SHOW THEM THAT, I SHOW THEM THE
COUPLE FIGURES, THEY ALL GO,
THIS IS GREAT, WE WANT TO DO IT
FOR XYZ.
WE'RE IN A POSITION NOW, BUT
THOSE INSTITUTES YOU ALL WORK
WITH ARE SUPER-SENSITIVE TO
THEIR COMMUNITIES.
SO I THINK YOU ALL CAN PROVIDE
FEEDBACK.
I MEAN, YOU'LL HEAR A
PRESENTATION AFTER THIS ON
TRYING TO EXTEND THIS IN SOME
WAYS THE LAST FRONTIER IS IN
BIOMATERIALS AND ENGINEERED
BIOLOGICAL SYSTEMS, WHICH ARE
NOT NECESSARILY AS FAR ALONG AS
THE HARD MATERIALS ENGINEERING
THAT WE'RE SEEING.
AND WE NEED TO FIGURE OUT HOW TO
DO THIS.
YOU'LL HEAR IN DAVE AND
STEPHANIE MORE ABOUT HOW WE
MIGHT BE ABLE TO EXTEND TO THOSE
DEMAINS BUT THAT'S ABSOLUTELY
CORRECT.
IF WE THINK WE COULD ON A
STRUCTURE THAT WE CAN COPY/PASTE
AND GIVE PEOPLE OPPORTUNITIES AT
RELATIVELY LOW RISK THEY CAN GET
INVOLVED WITH US.
>> THANK YOU.
>> THANKS.
>> THANK YOU.
ANY OTHER COMMENTS OR QUESTIONS
OR THOUGHTS FROM OUR COUNCIL
MEMBERS?
RANU, YOU RAISED USUAL HAND
AGAIN?
>> YEAH.
I RAISED MY HAND AGAIN.
AS WE'RE TALKING ABOUT THIS
FUNNEL MODEL, WE MIGHT ALSO WANT
TO THINK ABOUT SOME GUIDELINES
OF HOW ARE YOU BUDGETING.
YOUR BUDGET IS NOT
PRE-DETERMINED BECAUSE
MILESTONES HAVE BEEN MET,
WITHOUT -- YOU KNOW, SO MAYBE
THERE'S SOME HARD PROCESS TO BE
PUT ALONG WITH THAT OF
STRUCTURES TO BE SHARED IN
GUIDING THE SUBMITTERS OF HOW WE
SET UP BUDGET MODELS TO GO ALONG
WITH THAT FUNNEL.
>> YEAH, AND THIS NEW ONE WITH
NICHD AND MATERNAL HEALTH IS AN
EXPERIMENT BECAUSE AS YOU'VE
SEEN FROM OUR PREVIOUS RADx
FUNNEL BUDGETS THE FIRST WAS
$500 MILLION, SECOND WAS $100
MILLION.
THIS THIRD ONE IS $300 MILLION.
AND THIS FUNNEL IS $8 MILLION.
SO, QUITE DIFFERENT BUT IT'S
VERY, VERY FOCUSED.
AND IT'S TO A PARTICULAR DOMAIN.
ANOTHER THING THAT HELPED
SUPPORT THAT ALSO IF YOU LOOK AT
OUR POCTRN NETWORKS WE HAVE
SEVEN INSTITUTES IN THE
APPLICATION SPACE AREAS THAT ARE
DECORATED AROUND THESE CORE
CAPABILITIES.
AND SO THAT WILL HELP US HAVE
LESS EXPENSIVE FUNNELS.
IT'S AN ALTERNATIVE MECHANISM TO
OUR NORMAL, YOU KNOW, R01s AND
R21s, Ps, Us, SO FORTH BUT
IT IS CERTAINLY A POWERFUL ONE.
AND A KIND OF REALLY GOOD WAY TO
PLAY SMALL BALL IF YOU'RE A FAN
OF BASEBALL ANALOGIES, SPECIALLY
WITH AWARDS TO GET PEOPLE MONEY
QUICKLY AND GET ON BASE AND GET
MOVING.
AND THEN FOLLOW THAT UP WITH
LARGER LONG-TERM GRANTS.
>> TEJAL?
>> ALL THIS ECHO AGAIN.
MY THANKS FOR ALL THE IMPRESSIVE
WORK YOU'RE DOING.
IT'S TRULY REMARKABLE, REALLY,
THE PROGRESS THAT YOU'VE MADE.
ONE OF THE THINGS OR POINTS I
WANTED TO MAKE, I THINK THIS IS
PARTLY SOMETHING THAT WE CAN DO
IN COUNCIL, IS TO ALSO EDUCATE
THOSE ON THE OUTSIDE THAT THESE
NEW MECHANISMS ARE ACTUALLY, YOU
KNOW, QUITE -- THEY ARE, YOU
KNOW, QUITE IMPORTANT AND
ACTUALLY OF HIGH VALUE, AND THAT
THEY ARE PEER REVIEWED IN THE
SAME WAY THAT SOME OTHER
CONVENTIONAL MECHANISMS ARE.
THE REASON I SAY THAT, AS
SOMEBODY REVIEWING AT LEAST FOR
THE EARLY FACULTY THAT ARE
COMING DOWN THE PIPELINE AND
PROMOTIONS AND TENURE, AS THEY
START TO SHOW THESE TYPES OF
MECHANISMS, I'VE HAD TO ADVOCATE
THAT THESE ARE REALLY IMPORTANT,
THAT THEY ARE REALLY A MARK OF
INNOVATIVENESS AND, YOU KNOW,
REALLY PUTTING THEM IN THE TRACK
TO ACHIEVE THESE LARGER GRANTS
BUT THIS IS SOMETHING THAT I
THINK THE COMMUNITY AS A WHOLE
MIGHT WANT TO TAKE ON AND REALLY
SHOWCASE THAT THESE ARE
VALUABLE.
>> YEAH, TEJAL, YOU JUST
REALLY -- YOU CALLED OUT THE
CULTURAL CHALLENGES WHICH WE ALL
HAVE FACED THROUGH OUR CAREERS,
YOU KNOW, FIRST IT WAS IS
TEAM-BASED RESEARCH OKAY, HOW DO
YOU GET CREDIT FOR PEOPLE WHO DO
TECHNOLOGY INNOVATION, AND WE'LL
SEE A CONTINUED EVOLUTION OF
MECHANISMS, CERTAINLY THE R01
STANDARD IS STUCK IN OUR HEADS
AND PROMOTION AND TENURE
COMMITTEE HEADS, AS BEING THE
STANDARD BEARER, BUT IN A
DIFFERENT DOMAIN OF ACCELERATED
TECHNOLOGY DEVELOPMENT THESE
OTHER APPROACHES NEED TO ACHIEVE
A KIND OF GRAVITAS FOR THE
INVESTIGATORS, AND THAT'S GOING
TO BE A GROUP AND COMMUNITY
PROBLEM FOR US TO ADDRESS FOR
SURE.
BUT YOU GUYS ARE IN A GOOD
POSITION TO DO THAT, TO HELP
WITH THAT.
>> DAN?
>> YES, SO COMING IN NEW AS I
AM, FIRST OF ALL I ALSO WANT TO
ECHO CONGRATULATIONS ON A
REMARKABLE RECORD OF ACTIVITIES
AND IMPACT, AND I'LL BE HONORED
TO JOIN THIS DISTINGUISHED
COMMUNITY OF COUNSELORS.
AS I WAS LISTENING, I WAS
REFLECTING ON THE THEME OF
ACCESSIBILITY AND ALSO THE
QUESTION ABOUT ONGOING ROLE OF
IMAGING.
I GUESS I JUST WANTED TO NOTE
THAT THERE'S BEEN A REALLY
SERIOUS MOVE TOWARDS ADDRESSING
ACCESSIBILITY AND HEALTH
DISPARITY IN THE FIELD OF
IMAGING EVEN FOR DEVICES LIKE
MRI, CT, PET SCANNERS,
TRADITIONALLY BIG AND EXPENSIVE
AND RESOURCE HUNGRY.
SO IT'S NOT JUST WEARABLES AND
POINT OF CARE DEVICES, NOW
THERE'S MUCH MORE OF AN INTEREST
I THINK WORLDWIDE IN POINT OF
CARE IMAGING, AND I THINK THIS
IS ONE AREA THAT NIBIB COULD
POTENTIALLY PLAY A LEADING ROLE
AND THAT WOULD SOME WAYS CONNECT
SOME OF ITS DISPARATE AREAS OF
INTEREST AND FOCUS.
>> YEAH, ABSOLUTELY AGREE.
AND BOTH THE TECHNOLOGIES GOING
TO POINT OF CARE AND WE DO
SUPPORT A FEW OF THOSE, YOU
KNOW, LIKE HEAD ONLY MRIs, SO
FORTH, BUT ALSO THE LINKAGE
BETWEEN THE SMALL PHYSICS
TECHNOLOGY WHICH IS ON OR IN THE
PATIENT, AND THE INFORMATION
GENERATION THAT MAY BE
ACTIONABLE THAT SAYS, OKAY,
PATIENT, GO TO THE BIG PHYSICS
NOW.
SO THAT'S ABSOLUTE -- THERE IS
A -- WE NEED TO DO BETTER WITH
THAT.
I THINK PART OF IT IS SOME OF
THE BIAS OF THE MEDICAL
COMMUNITY THAT IS NOT QUITE
READY TO SORT OF CONNECT ALL
THOSE PIECES BUT THE RESEARCH
COMMUNITY IS OUT THERE, MAKING A
HUGE EFFORT, AND ALL OF US IS
ONE OF THOSE EXAMPLES WHERE
WE'RE HOPING TO IMPACT, I THINK
WE'RE ON THE VERGE OF GETTING
CLOSE TO WHERE "ALL OF US" MAY
INTRODUCE IMAGING INTO ITS
PROGRAM.
SO WE'RE WORKING ON THAT.
THAT WILL BE FOR FUTURE
COUNCILS.
>> MAYBE I CAN JUST JUMP IN TO
REINFORCE THAT POINT.
I HEARD AN INTERESTING NUMBER IN
OUR INSTITUTION, APPARENTLY THEY
ARE PLANNING THAT 10% OF THE
HOSPITALIZED PATIENTS WILL BE
HOME HOSPITAL PATIENTS.
AND OF COURSE, THIS IS EXACTLY
AS DAN WAS SUGGESTING, AN
OPPORTUNITY, YOU KNOW, BOTH FOR,
YOU KNOW, MONITORING AT HOME BUT
ALSO HOW WE CAN THINK ABOUT
GETTING THE KIND OF DATA THAT
WE'RE USED TO GETTING IN A
HOSPITAL SETTING, PORTABLE AND
HOME HEALTH SETTINGS, ET CETERA,
A REMARKABLE NUMBER, IT'S A LOT
OF PATIENTS, BUT THAT IS THE
DIRECTION I'M SURE ALL
INSTITUTIONS ARE MOVING TOWARDS.
>> ABSOLUTELY.
I MEAN, WE NEED TO DO BETTER
WITH QUANTITATIVE METROLOGY IN
THE HOME.
WE'RE ALL -- WE'VE ALL BEEN
WORKING IN THESE AREAS.
WE KNOW SIGNALS ARE AVAILABLE
AND TECHNOLOGIES ARE DOABLE.
AND WE'VE SEEN THE EXPLOSION OF
IT WITH IN VITRO DIAGNOSTICS.
I'M STILL ASTOUNDED BY THOSE
NUMBERS, I CAN BARELY SAY THEM,
ONE BILLION IN VITRO TESTS
DISTRIBUTED.
A LOT OF PRESS REPORTS THAT IN
VITRO DIAGNOSTICS DON'T WORK
THAT WELL BUT THEY ACTUALLY WORK
REALLY WELL.
IT'S JUST THAT WHEN YOU HAVE A
BILLION OF THEM OUT, THAT ARE
RELEASED, THERE ARE GOING TO BE
MAYBE 100 MILLION PEOPLE
UNHAPPY.
YOU'LL HEAR ABOUT THEM.
AND IT'S JUST A COMPLETE
PARADIGM SHIFT, STILL HARD FOR
ME TO GET MY HEAD AROUND BUT
SLIGHTLY -- ABSOLUTELY THIS HAS
TO BE COMING FROM ALL DIRECTIONS
IN THE COMMUNITY, THE BIG AND
LITTLE PHYSICS.
>> THANK YOU.
JOYCE AND ZANE AND THEN BRUCE
WILL WANT TO THINK ABOUT MAYBE
SUMMING UP.
WE'RE RUNNING OVER ON THIS
SEGMENT.
GREAT DISCUSSION.
THANK YOU.
>> YES, I JUST WANT TO ALSO ECHO
WHAT EVERYBODY SAID.
THIS IS TREMENDOUS, MY FIRST
TIME HERE, I ECHO WHAT DAN SAID,
I'M EXCITED TO JOIN COUNCIL.
I WANTED TO SAY I THINK IT'S
FANTASTIC WITH THE PARTNERSHIP
WITH NICHD AND FUNNEL MODEL, I
THINK THAT'S SO WONDERFUL DOING
MATERNAL HEALTH.
I THINK IT'S REALLY VERY
UNDERFUNDED AND I THINK THAT'S
FANTASTIC.
MY COMMENT IS ACTUALLY FOR JILL.
I THINK THAT WAS TREMENDOUS WHAT
YOU'VE DONE WITH ACCESSIBILITY
AND HAVING THOSE GUIDELINES AND
YOU MENTIONED HAVING THEM REALLY
OPENLY AVAILABLE SO I MYSELF
TEACH A DESIGN COURSE TO JUNIORS
AND SENIORS I THINK IT WOULD BE
WONDERFUL TO HAVE THAT MATERIAL
AVAILABLE FOR EDUCATION AND SO A
LOT OF, AS YOU KNOW, IN THE
DEBUT CHALLENGES, I THINK IT
WOULD BE GREAT TO EMBED THAT
INTO THE CURRICULUM SO ANY KIND
OF WAY YOU CAN SHARE THAT
INFORMATION, A WAY WE CAN ADOPT
IT INTO OUR CURRICULUM THAT
WOULD BE REALLY NICE.
>> THAT'S EXCITING, JOYCE.
THAT'S GREAT TO HEAR.
SO, WHAT WE'D LIKE TO DO IS
RELEASE THE INFORMATION IN
STAGES, SORT OF AS DIFFERENT
ASPECTS MATURE LIKE THE
INSTRUCTIONS FOR USE WILL BE
COMING ONLINE PRETTY QUICKLY.
AND WORK WITH THE U.S. ACCESS
BOARD TO KEEP PUTTING THINGS OUT
AS THEY ARE READY.
WE'VE GOT SOME URGENCY BECAUSE
WE'D LIKE THEM TO BE AVAILABLE
FOR NEW SOLICITATIONS, ASKING
FOR PEOPLE TO ADDRESS
ACCESSIBILITY.
WE'RE ON A PRETTY FAST TRACK I
THINK, TRYING HARD TO GET SOME
STUFF AVAILABLE FOR THIS FALL,
FOR THE FALL CLASSES.
WHICH I HADN'T APPRECIATED.
THANK YOU, THAT'S A GREAT IDEA.
>> THANK YOU, JOYCE.
ZANE?
>> THANKS, EVERYBODY.
I'M GOING TO ADD TO THE
CONVERSATION ABOUT THE DIVERSITY
BECAUSE I THINK THIS COMMUNITY
HAS A GREAT OPPORTUNITY RIGHT
NOW TO REALLY CONTRIBUTE TO
PERSONALIZED MEDICINE.
THE KEY IS EVERYTHING'S MOVING
TOWARDS YOU AS THE INDIVIDUAL
BEING THE DIVERSIFIED OBJECT IN
YOUR OWN PERSONAL HEALTH CARE.
AND RIGHT NOW THERE'S A LOT NOT
UNDERSTOOD ABOUT EVEN THE
UNDERLYING FACTORS THAT AFFECT
THAT.
PRIME EXAMPLE IS THE PULSE OXY
METER, NO LATERAL AGREEMENT IT'S
THE PROBLEM AND NOT UNILATERAL
AGREEMENT WHETHER COLOR AND SKIN
COLOR IS THE PRIMARY FACTOR IN
THAT DIFFERENTIATING FACTOR IN
THESE STUDIES.
THE PROBLEM IS THERE'S A LOT OF
FACTORS THAT COULD POTENTIALLY
BE CONTRIBUTING AND WE DON'T
UNDERSTAND THEM.
THERE'S A GREAT OPPORTUNITY TO
USE A.I. TO LOOK AT A VARIETY OF
FACTORS TO HELP UNDERSTAND HOW
WE'RE GOING TO TAKE THIS
MEDICINE AND AS DAVE SAID
EARLIER FROM THE HOSPITAL TO THE
PATIENT AT HOME, GETTING BETTER
HEALTH CARE FOR PATIENTS AT HOME
AS OPPOSED TO IN A HOSPITAL
WHERE A MEDICAL PHYSICIAN IS
THERE.
>> THANKS, ZANE.
I'M GOING TO TURN THAT BACK
AROUND TO ALL OF YOU, MY
COLLEAGUES, BECAUSE I AM STRUCK,
I'VE BEEN OVERWHELMED BY THE
ABSENCE OF EXPERTISE OUR
COMMUNITY BRINGS ACROSS
GOVERNMENT, MAJOR INSTITUTIONS
ACROSS GOVERNMENT.
THIS HAS ALL BECOME VERY OBVIOUS
AS WE'VE PUSHED HARD INTO OUR
COVID RESPONSE.
AND EVEN IN THE NIH, YOU KNOW,
WE'RE PRETTY UNIQUE BECAUSE I
THINK PEOPLE DO A FINE JOB OF
IDENTIFYING MANY OF THESE
PROBLEMS BUT TO HAVE THE SORT OF
TECHNOLOGY FOUNDATION AND
UNDERSTANDING OF DETAILS OF HOW
STUFF WORKS IS REALLY LACKING,
ESPECIALLY AS WE MOVE INTO
BROADER AREAS OF MEDICINE,
PUBLIC HEALTH, EPIDEMIOLOGY.
YOU PROBABLY HEARD ME SAY THIS
BEFORE, THIS IS MY PLEA.
WE'RE HOPING TO BE ABLE TO WORK
WITH NSF ON THIS TO EXPAND
STRANGE OPPORTUNITIES FOR
BIOMEDICAL ENGINEERS TO HAVE
CAREER CHOICES TO COME INTO
GOVERNMENT.
FDA HAS GOT FANTASTIC COLLECTION
OF ENGINEERS AND PHYSICAL
SCIENTISTS, BUT WE NEED MORE AND
WE NEED THEM IN OTHER AGENCIES
SO THEY CAN SPEAK TO FOLKS
BECAUSE A LOT OF THE ONES IN THE
FDA ARE NOT NECESSARILY
INFLUENCING ALL ASPECTS OF
WHAT'S GOING ON IN THE FDA.
ESPECIALLY AT THE POLICY LEVEL.
AND AS YOU ALL KNOW, YOU'VE GOT
TO HAVE THAT DETAILED
UNDERSTANDING OF HOW STUFF WORKS
TO REALLY MAKE A DIFFERENCE AND
IMPACT.
I SEE WHAT WE'VE BEEN ABLE TO DO
IN THE PANDEMIC, AS A COMMUNITY
EXPERTISE KIND OF THING.
AND WE WANT TO EXPAND THAT AS
YOU POINT OUT, ZANE, IN ALL
ASPECTS OF PERSONALIZED MEDICINE
AND HEALTH.
>> THANK YOU FOR EXCELLENT INPUT
AND DISCUSSION.
ANYTHING BEFORE WE TRANSITION TO
THE NEXT PRESENTATION.
>> WE TEED UP THE NEXT ONE.
OH MY GOSH.
DATA AND SELF-MATERIALS, LET'S
JUST GET GOING.
>> SUPER.
THANK YOU SO MUCH.
NEXT ITEM IS PRESENTATION FROM
OUR COLLEAGUE DR. QUI DUAN ON
DATA MANAGEMENT AND SHARING
POLICY, THOSE OF YOU WHO HAVE
BEEN NO DOUBT ATEN I ATTENTIVE
TO NIH NEWS ARE AWARE OF THE BIG
THING COMING DOWN THE PIKE, AND
DELIGHTED TO HAVE QI GIVE AN
UPDATE.
THANK YOU, QI.
>> THANK YOU FOR THE
INTRODUCTION.
TODAY I WILL GIVE A BRIEF UPDATE
ON THE NIH DATA MANAGEMENT AND
SHARING POLICY AS WELL AS
CORRESPONDING UPDATE AND FOLLOW
THE PRESENTATION BY DISCUSSION.
TO CLARIFY THE DISCUSSION TODAY
IT'S ONLY FOCUSING ON DATA
MANAGEMENT AND SHARING PART.
THERE ARE OTHER PARTS IN THE
RESEARCH SHARING PLAN, JUST LIKE
OTHER SOFTWARE SHARING OR
TECHNOLOGY SHARING, NOT COVERED
BY TODAY'S DISCUSSION.
WE MAY TOUCH A LITTLE BIT ON THE
PUBLICATION SHARING AS NEEDED.
A BRIEF HISTORY OF THE DATA
SHARING POLICY, CURRENT DATA
SHARING POLICY CAME IN EFFECT IN
2003.
IN 2015 NIH STARTED ITERATIVE
NEW POLICY DEVELOPMENT PROCESS,
NEW DATA MANAGEMENT SHARING
POLICY WAS RELEASED IN 2020,
WHICH WILL COME TO EFFECT IN
2023.
THE GOAL OF THE POLICY IS TO
ADVANCE RIGOROUS AND
REPRODUCIBLE RESEARCH AND
PROMOTE PUBLIC TRUST IN
RESEARCH.
HERE IS A COMPARISON OF THE
CURRENT AND NEW POLICY.
THE CURRENT POLICY APPLIES TO
ANY APPLICATIONS WITH MORE THAN
500K DIRECT COSTS PER YEAR.
AND NEW POLICY WILL APPLY TO ALL
RESEARCH STUDIES GENERATING THE
SCIENTIFIC DATA.
AND IN THE SUBMISSION, CURRENT
POLICY REQUIRES DATA SHARING
PLAN TO BE SUBMITTED.
THE NEW POLICY ADDED AS DATA
MANAGEMENT PART TO THE PLAN, IF
YOU LOOK AT THE DEFINITION OF
DATA MANAGEMENT, IT INCLUDES
EFFORTS NECESSARY FOR SCIENTIFIC
RIGOR ANYWAY.
THE COMPLIANCE EXPECTATION
REMAINS SIMILAR WITH NOTICEABLE
CHANGES FOR NEW POLICY SUCH AS
THE PUBLICATION TRIGGER AND PLAN
EVALUATION PROCESS.
JUST TO CLARIFY THE FOCUS IS TO
HAVE A PLAN TO MANAGE AND SHARE
THE DATA, IT'S NOT A UNIVERSAL
REQUIREMENT TO SHARE ALL THE
DATA.
A TWO-PART WEBINAR SERIES TO
OFFER ADDITIONAL CLARIFICATION
SUCH AS GOALS AND EXCLUSIONS,
PRELIMINARY ANALYSIS, APPLICABLE
MECHANISM AND INFORMATION AND
RESOURCES FOR PLANNED
DEVELOPMENT AS A MISSION, ET
CETERA.
DATA PROVIDED ON THE SLIDE FOR
SLIDE DECK AND RECORDING FOR
FIRST SESSION AND REGISTRATION
INFORMATION FOR THE UPCOMING
SESSION.
THE NEW POLICY IS TRANS-NIH
MINIMUM REQUIREMENT, SPECIAL
FUNDING OPPORTUNITY ANNOUNCEMENT
MAY HAVE THEIR OWN REQUIREMENT
ON THE DATA MANAGEMENT SHARING,
AND JUST AS MENTIONED IT'S NOT A
UNIVERSAL REQUIREMENT FOR
SHARING ALL DATA, ONLY FOCUSING
ON SCIENTIFIC DATA, WHICH HAS
THE SUFFICIENT TO VALIDATE AND
REPLICATE RESEARCH FINDINGS.
SCOPE OF THE DATA IS APPARENTLY
PROJECT DEPENDENT.
A WORKING GROUP WAS FORMED THIS
YEAR, WORKING GROUP MEMBERS COME
FROM VARIOUS PARTS OF THE
INSTITUTES SUCH AS EXTRAMURAL
SCIENTIFIC PROGRAM DIVISIONS,
INFORMATION TECHNOLOGISTS,
REVIEWS, COMMUNICATION.
THE GOAL IS TO DEVELOP NIBIB'S
IMPLEMENTATION THAT IS TAILORED
TO OUR YOUR NUKE NEED AND
PRIORITIES, WHILE MAINTAINING
THE COMPATIBILITY WITH THE NIH
POLICY.
YOU HAVE PROBABLY SEEN THIS
SLIDE BEFORE IN PRIOR COUNCIL
MEETINGS, FROM TECHNOLOGY
INNOVATION POINT OF VIEW NIBIB
HAS ITS UNIQUE POSITION IN THE
NIH FAMILY WHICH PRIORITY
FOCUSING ON ENGINEERING THE
FUTURE OF HEALTH.
NIBIB'S PART OF THE AGE OF
TECHNOLOGY ENGINEERING ECOSYSTEM
FOCUS ON DRIVING TECHNOLOGY
INNOVATIONS WITH BROAD ABILITY
AND INTERACTING AND
COLLABORATING WITH OTHER I.C.s
TOGETHER TO FULFILL THE NIH
MISSION, MISSION PRIORITY
DETERMINES UNIQUE RELATIONSHIP
BETWEEN RESEARCH FINDINGS AND
DATA.
LET'S TAKE A CLOSER LOOK.
THE TYPE OF RESEARCH SUPPORTED
BY NIH TRADITIONALLY
HYPOTHESIS-DRIVEN RESEARCH, SUCH
AS CLINICAL TRIALS.
THIS TYPE OF RESEARCH USUALLY
STARTS WITH HYPOTHESIS AND
INVESTIGATORS NEED TO DESIGN A
STUDY AND ACQUIRE SIGNIFICANT
AMOUNT OF DATA WHICH NEEDS TO BE
MANAGED AS MENTIONED EARLIER,
AND TO SUPPORT HYPOTHESIS
TESTING WHICH LEADS TO RESEARCH
FINDINGS.
DATA POINTS ARE IMPORTANT ROLE
HERE TO SUPPORT RESEARCH
FINDING.
IN CONTRAST FOR TECHNOLOGY
DIVERSITIEN RESEARCH SUCH AS
MATHEMATICAL FRAMEWORK, IMAGING,
USUALLY START FROM FIRST
PRINCIPLES WERE ENGINEERING
DESIGNS WHICH LEAD TO RESEARCH
AND DEVELOPMENT AND THIS PROCESS
USUALLY INVOLVES SIGNIFICANT
AMOUNT OF PRELIMINARY EFFORT AND
ANALYSIS, BACK AND FORTH, TRIALS
AND ERRORS, GOING BACK TO THE
DRAWING BOARD BEFORE ANYTHING
RISES TO SUFFICIENT QUALITY TO
BECOME SHARED TECHNOLOGY.
DEPENDING ON THE NATURE OF THE
RESEARCH, DATA MAY BE NEEDED IN
R&D PROCESS, HOWEVER WITH SOME
EXCEPTIONS THE DATA NEED FOR R&D
IS USUALLY SMALLER WHEN COMPARED
WITH THE NEED FROM
HYPOTHESIS-DRIVEN RESEARCH.
EVEN FOR DATA-DRIVEN RESEARCH
THERE ARE USUALLY BENEFITING
FROM DATA SHARING POLICY, THEY
ARE CUSTOMERS FOR DATA REUSE.
TECHNOLOGY FINDINGS MAY IN TURN
ENABLE THE NEXT GENERATION OF
TECHNOLOGY INNOVATIONS FOR
EXAMPLE IN LAST CENTURY THE
INNOVATION IN MR SCANNERS LEADS
TO IMAGING SEQUENCES, WHICH
FURTHER LED TO ADVANCEMENT IN
NEUROIMAGING SEQUENCE.
THE TECHNOLOGY MAY ALSO ENABLE
THE NEXT GENERATION CLINICAL
RESEARCH BENEFITING
HYPOTHESIS-DRIVEN RESEARCH BY
PROVIDING TECHNOLOGYING BRIDGING
THE GAP IN DATA NEED.
FOR EXAMPLE ADVANCEMENT IN
NEUROIMAGING MENTIONED EARLY
ENABLES ALZHEIMER'S DISEASE
INITIATIVE STARTING IN 2004
WHICH IS ALSO SUPPORTED BY THE
DATA SCIENCE TECHNOLOGY
DEVELOPED BY CENTERS, DATA
SHARED BY THIS INITIATIVE IN
TURN BECOMES RESOURCE FOR NEW
TECHNOLOGY DEVELOPMENT.
AS MENTIONED EARLIER, NIBIB IS
FOCUSED ON TECHNOLOGY
DEVELOPMENT WITH BROAD
APPLICABILITY, USUALLY NOT
DOMAIN SPECIFIC.
AND WE ALSO HAVE A BROAD
SPECTRUM IN TERMS OF TYPE OF
RESEARCH, SUPPORT CLINICAL
TRIALS, LIMITED TO EARLY STAGE
AND PHASE 1 STUDIES.
LET'S COME BACK TO THE GUIDING
PRINCIPLE, IMPROVED
REPRODUCIBILITY AND RELIABILITY.
NIBIB-SUPPORTED RESEARCH
PUBLICATION IS ONE EFFECTIVE
AVENUE FOR SHARING RESEARCH
FINDINGS OR RECIPES FOR
TECHNOLOGY.
FOR EXAMPLE, THE MATHEMATICAL
FRAMEWORK IN THIS PAPER FOR THE
BOUNDARY CONDITIONS IN OPTICAL
IMAGING, THEY ACTUALLY ENABLED
NUMEROUS FURTHER TECHNOLOGY
INNOVATIONS IN THE OPTICAL
IMAGING FIELD.
AND IN TECHNOLOGY FOCUSED FIELD
PUBLICATION INCLUDES MANY FORMS.
SUCH AS PEER REVIEWED JOURNALS,
CONFERENCE PAPER, PRE-PRINT,
ENABLE TECHNOLOGY CHANGE,
ESPECIALLY IN PANDEMIC RESPONSE,
AND THEY ALSO PROVIDE AVENUE TO
SHARE TECHNOLOGY FINDINGS OR
LESSONS LEARNED.
THE DATA AND INFORMATION
PROVIDED IN THE PUBLICATION
USUALLY PLAYS AN IMPORTANT ROLE
FOR RELIABLE REPRODUCTION, IT'S
ASSOCIATE MATHEMATICAL
FRAMEWORK, ESSENTIAL TO
REPRODUCE M.R. IMAGING SEQUENCE.
SCIENTIFIC INFORMATION DOES NOT
REMAIN SPECIFIC, REPOSITORIES
SUCH AS ECOSYSTEM THAT NIH IS
BUILDING RIGHT NOW MAY OFFER
SUFFICIENT AND LOW COST
SOLUTIONS FOR DATA SHARING
NEEDS.
AND AS MENTIONED EARLIER, IN
ADDITION TO BROAD ACCESSIBILITY,
SUPPORTS VARIOUS TYPES OF
RESEARCH IF A RESEARCH IS
FOCUSING ON DEVELOPING RECIPES
FOR TECHNOLOGY AND ENGINEERING
DESIGNS SUCH AS OPTICAL IMAGING
EXAMPLE SHOWN EARLIER.
TECHNOLOGY OUTCOME SHARED
THROUGH PUBLICATION WAS MINIMAL
SCIENTIFIC DATA NEED BEYOND THE
PUBLICATION AND SUPPORTING DATA
CAN BE SHARED AS SUPPLEMENTAL
INFORMATION OR USING GENERAL
REPOSITORY.
SOME ENGINEERING DESIGN PROJECT
MAY GENERATE ADDITIONAL
SUPPORTING DATA, HERE IS THE
EXAMPLE TO DEVELOP NOVEL
NANOPARTICLES TO BRING DELIVERY
AND RECIPE OF TECHNOLOGY IS
SHARED WHILE PUBLICATION,
WHEREAS THE ACTUAL MATERIAL IS
SHARED WHILE MATERIAL TRANSFER
AGREEMENTS, THERE MAY BE
ADDITIONAL SUPPORTING DATA LIKE
ANIMAL STUDY OR OTHER METADATA,
TO SUPPORT THE RESEARCH OUTCOMES
WHICH CAN BE FURTHER SHARED AS
SUPPLEMENTARY INFORMATION OR
GENERATE THROUGH GENERALIST
REPOSITORY, THERE MAY BE IN SOME
CASE SPECIFIC REPOSITORY, IN
THIS CASE NANOMEDICINE
REPOSITORY.
IN SOME CASES WE SUPPORT
DATA-DRIVEN OR HYPOTHESIS-DRIVEN
APPROACHES, THERE'S A MODEL WITH
PROSPECTIVE CLINICAL STUDY,
METHODS AND KEY FINDINGS SHARED
WITH PUBLICATIONS, SOFTWARE
SHARED WITH OTHER CHANNELS,
THERE MIGHT BE DATA GENERATED TO
SUPPORT RESEARCH OUTCOME.
NIH SHARES WEBSITE PROVIDES
ADDITIONAL GUIDELINE FOR
PROVIDING DATA MANAGEMENT
SHARING PLAN AS WELL AS SOME
GUIDANCE HOW TO SELECT THE
PROPER REPOSITORIES.
PLEASE NOTE THE LAST TYPE OF
PROJECT IS THE CURRENT
PORTFOLIO, DUE TO LIMITATIONS ON
CLINICAL TRIALS, SIGNIFICANT
PORTION OF DATA DRIVEN
APPROACHES, SECONDARY DATA
ANALYSIS AS MENTIONED BEFORE.
SO, RIGHT NOW NIH CONTINUES TO
BACK INVESTIGATORS TO PUBLISH
RESEARCH FINDINGS, INCLUDING
POSITIVE OUTCOMES AS WELL AS
LESSONS LEARNED AND CAN CONSIDER
RAISING ALL THE FORMS OF
PUBLICATION, INCLUDING JOURNAL,
CONFERENCE PAPER, PRE-PRINTS
WITH DOIs, AND THE SCIENTIFIC
DATA FOR REPRODUCING PUBLISHED
TECHNOLOGY, AND SHARE DATA IN
PUBLICATION.
AND AS USUAL THE PROGRAM STAFF
IS HERE TO HELP.
ADDITIONAL GUIDANCE HERE, IF YOU
ARE INVESTIGATOR, THEN YOU
SHOULD CONSIDER DEVELOPING A
PLAN RELEVANT TO YOUR PROJECT
LEVERAGING RESOURCES PROVIDED BY
NIH DATA MANAGED SHARING WEBSITE
AS WELL AS OTHER PUBLIC TOOLS
THAT IS AVAILABLE TO YOU.
AND JUST TO CLARIFY THAT THE
POLICY IS THE MAIN REQUIREMENT,
P.I. MAY CHOOSE TO GO ABOVE AND
BEYOND AND TO USE WHATEVER THEY
THINK IS THE BEST PROCESS FOR
ENABLE DATA SHARING REUSE.
USUALLY FOR OUR PROJECT
SHAREABLE DATA PROBABLY WOULD BE
THE DATA THAT ACCOMPANIES
PUBLICATION, FOR ANY QUESTIONS,
FOR EXAMPLE, YOU COULD HAVE
SCIENTIFIC DATA WITHOUT
PUBLICATION, PLEASE FOLLOW THE
NIH GUIDANCE AS WELL AS
CONTACTING OUR PROGRAM STAFF.
AND NIH SHARE WEBSITE IS
OFFERING A ONE-STOP SHOP FOR
DEVELOPING DATA MANAGEMENT
SHARING PLAN AS WELL AS OTHER
PART OF RESOURCE SHARING PLAN
AND IT'S ANTICIPATED THAT THE
MORE RESOURCES LIKE TEMPLATES
AND PLANS MAY BE AVAILABLE IN
THE FUTURE.
SO WITH THAT I'M OPEN FOR
DISCUSSION.
THANK YOU.
>> GREAT.
THANK YOU VERY MUCH, QI.
COUNCIL MEMBERS, ANY QUESTIONS
OR COMMENTS FOR QI?
>> I'LL GO FIRST.
I THINK THIS IS AN EXCELLENT
IDEA.
I OFTEN MAKE A STATEMENT TO
PEOPLE THAT I FOUND PUBLICATIONS
ARE NO LONGER REPRODUCIBLE AND
PRETTY WORTHLESS WITHOUT A LOT
OF DATA YOU NEED FROM THE LABS.
THEY ARE NEW NICHE.
AT THE FDA WE STARTED PUTTING
TOGETHER CATALOG.
ANYTHING WE GENERATE, ANY
PROGRAMS WE'RE USING AS FAR AS
INTERNALLY GENERATED PROGRAMS
BEING UTILIZED TO ANALYZE DATA,
PUBLISH CASES, TO HELP REPRODUCE
THE DATA, IT'S A GREAT IDEA TO
GET THINGS MOVING IN THAT
DIRECTION WHERE THINGS ARE MORE
REPRODUCIBLE.
>> THANK YOU.
>> GREAT.
THANKS.
FANTASTIC, I KNOW FDA IS
STRONGLY CONSIDERING A PARALLEL
EFFORT OF THEIR OWN ACCORD.
SAM?
>> THANK YOU AGAIN.
THAT WAS GREAT PRESENTATION.
ONE OF THE CHALLENGES WE FACE IN
ACADEMIA IS THIS, IS THAT USING
LAB NOTEBOOKS TO RECORD DATA,
GRADUATE STUDENTS ARE FINISHED
AND GONE, YOU WANT TO REASSESS
DATA, YOU CAN'T FIND YOUR LAB
NOTEBOOK.
IS THERE A MOVE THAT COULD BE
SUPPORTED GENERALLY LAB NOTEBOOK
FOR NIH-SPONSORED INVESTIGATORS
SUCH THAT AT LEAST THEY CAN BE
RETRIEVED AT ANY POINT IN TIME.
I DON'T KNOW ABOUT YOU GUYS, BUT
IT'S BEEN SOME TIME AND GRADUATE
STUDENT IS GONE, SO IS THERE A
MOVE TO MOVE TO ELECTRONIC LAB
NOTEBOOK THAT WE CAN SEE THE
RESPONSE FOR A LONG TIME?
>> YEAH, THANK YOU FOR THAT
COMMENT.
THAT'S ACTUALLY THE REASON WHY
NIH ARE ADDING DATA MANAGEMENT
INTO THE PLAN THAT IS REQUIRING
THE INVESTIGATORS TO CONSIDER
DATA MANAGEMENT BEFORE A PROJECT
IS STARTED.
IF YOU LOOK AT DEFINITION,
ENSURING KEY INFORMATION THAT
HAS BEEN KEPT IN A WAY THAT CAN
BE REPRODUCIBLY REUSED, EVEN FOR
THEIR OWN TEAM MEMBERS AND
THAT'S EXACTLY EFFORT AND
INVESTIGATOR SHOULD DO TO ENSURE
THE PROPER SCIENTIFIC RIGOR.
ONE OF THE ASPECTS OF THE NEW
DATA SHARING POLICY IS CODIFY
DATA MANAGEMENT AS PART OF
EXPECTATION FOR ALL
NIH-SUPPORTED RESEARCH THAT
REQUIRES INVESTIGATOR TO PUT IN
EFFORT TO HAVE A FRAMEWORK THAT
IS APPLICABLE TO THEIR OWN
PROJECT, TO ENSURE PROPER DATA
MANAGEMENT.
ON THE SECOND ASPECT OF NIH
PUSHING FOR ELECTRONIC NOTEBOOK,
THEY DO HAVE BROAD SPECTRUM OF
PROJECTS, AND LIKE MOST OF THE
POLICY NIH ACTUALLY GAVE
FLEXIBILITY TO P.I. TO CONSIDER
AND DEVELOP A PLAN SUITABLE FOR
THEIR OWN CASE.
AND AT THE MOMENT THERE'S NO
UNIVERSAL REQUIREMENT TO HAVE,
YOU KNOW, DICTATING ALL HAS TO
BE ELECTRONIC AND LAB NOTEBOOK
IS NOT CONSIDERED SCIENTIFIC
DATA TO BE SHARED BY THE CURRENT
POLICY AND SO IT IS A GOOD
PRACTICE FOR P.I. THAT, YOU
KNOW, I PROBABLY PERSONALLY WILL
RECOMMEND BUT IT DEPEND ON
INVESTIGATOR TO DEVISE A MAN FOR
THE SITUATION.
>> THANK YOU.
I SEE GOING BETWEEN PICTURES,
SIMON AND CYNTHIA AND MARYELLEN.
IF I WENT OUT OF ORDER, SORRY
ABOUT THAT.
>> HI, YEAH, THAT WAS A REALLY
GREAT PRESENTATION.
I HAD A QUESTION ABOUT SHARING
HUMAN IMAGING DATA, SOMETHING
WE'VE BEEN DOING A LOT THE LAST
COUPLE YEARS, AND WE'RE RUNNING
INTO QUITE A LOT OF
INCONSISTENCIES ABOUT
ANONYMIZATION IN TERMS OF FACIAL
RECOGNITION, WITH OUR ADVANCED
IMAGING TECHNOLOGIES TODAY YOU
CAN RENDER FACES.
THERE ARE TOOLS OUT THERE, M.R.
COMMUNITY HAS BEEN USING THEM
FOR QUITE A WHILE.
WE'RE SEEING A LOT OF DEBATE
BETWEEN IRB DATA SHARING AN
PEOPLE AND I'M WONDERING WHAT
NIH'S GUIDANCE IS ON THIS AND
WHETHER THERE MIGHT BE TOOLS
DEVELOPED THAT WE COULD SHARE AS
A COMMUNITY THAT WOULD HELP US
SHARE DATA IN AN ANONYMIZED.
>> THANK YOU, GREAT QUESTION AND
SUGGESTION.
DATA SHARING IS NOT STARTING
TODAY.
IT'S ALREADY STARTED.
THE POLICY STARTED IN 2003, AND
WITH WITH ADVANCE OF DATA SIGHEN
AND DATA SHARING IN PARALLEL
THERE ARE LESSONS LEARNED ALONG
THE PROCESS LIKE OFFICIAL
RECOMMENDATION
MAY NOT BE A CONCERN TEN YEARS
AGO BUT INCREASING A CONCERN IN
RECENT DEVELOPMENT.
THERE ARE EFFORTS TO DEVELOP
PROPER TOOLS FOR ANONYMIZATION,
BUT FROM DATA MANAGEMENT SHARING
POLICY POINT OF VIEW, THERE ARE
ADDITIONAL GUIDANCE PROVIDED ON
THE NIH DATA MANAGEMENT SHARING
WEBSITE, FOR CONSIDERATIONS WHEN
YOU'RE HANDLING SENSITIVE DATA
INCLUDING PATIENT DATA THAT
THERE ARE MULTI-FACETED ASPECTS
THAT YOU NEED TO CONSIDER FROM
THE INFORMED CONSENT AND HOW YOU
CHOOSE THE REPOSITORY AND THERE
ARE SITUATIONS THAT MAY MAYBE
SHARING DATA IS PROHIBITED BY
REGULATIONS AND SPECIFIC
RESEARCH AGREEMENTS, SO THE
INVESTIGATOR IN GENERAL YOU
SHOULD LOOK AT THE SITUATION
THAT YOU ARE DEALING WITH AND
WHAT'S THE PROJECT AND WHAT'S
THE DATA INVOLVED AND WHAT'S THE
SCIENTIFIC DATA PART TO SHARE
AND LOOK AT THE PROPER WAY TO
SHARE.
THE REQUIREMENT IS NOT TO SHARE
DATA, IT'S TO MAXIMIZE DATA
SHARING.
IF THERE'S NO GOOD WAY TO
DE-IDENTIFY DATA, WHAT'S THE
RISK FOR THE INDIVIDUAL SUBJECT
AND THERE COULD BE FACTORS TO BE
CONSIDERED, DATA SHARING, ALSO
ACCEPTABLE BY CURRENT POLICY.
SO, IT'S CASE BY CASE, IT'S NOT
A STRAIGHT ANSWER TO THE
QUESTION, RESEARCH STILL ONGOING
BUT FOR INDIVIDUAL PROJECT
RECOMMEND TO CONTACT THE PROGRAM
STAFF TO DISCUSS AND IN DETAIL
AND I HOPE THAT ANSWERS YOUR
QUESTION TO SOME EXTENT.
>> THANK YOU.
>> VERY IMPORTANT THING WE NEED
TO FACTOR IN AT NIH.
SO THANK YOU.
CYNTHIA AND THEN MARYELLEN.
>> THANK YOU FOR EVERYTHING
THAT'S BEEN SHARED TODAY, BRUCE
AND JILL.
I'M EXTREMELY PROUD TO BE
PARTICIPATING IN NIBIB COUNCIL,
HEARING ALL TREMENDOUS THINGS
BEING DONE.
THE PRESENTATION WAS PRIMARILY
ABOUT POLICIES BUT I'M WONDERING
ABOUT RESOURCES AND WHETHER FOR
IMAGING DATA THIS IS SOMETHING
EVEN THAT MIDRC MIGHT HAVE A
ROLE IN FOR ONE OF MY GRANTS WE
MADE A VERY LARGE DATASET OF
IMAGE DATA AND PROJECTION DATA
THAT THE NATIONAL CANCER
INSTITUTE'S IMAGE ARCHIVE
PROGRAM HAS MADE AVAILABLE SPACE
FOR US TO SHARE IT.
IT'S A SLOW PROCESS FOR THEIR
CURATION AND THEY HAVE PEOPLE
THAT NEED FUNDING.
I'M JUST WONDERING WHETHER
NIBIB, NOW THAT WE'RE COMING UP
WITH THESE STANDARDS FOR DATA
SHARING, CAN FACILITATE A WAY TO
GET DATASETS OUT THERE, I SEE
MARYELLEN SHAKING HER HEAD.
THAT WAS MY COMMENT.
>> YEAH, THANK YOU FOR THE
COMMENT.
I WILL START WITH THE ONE-STOP
SHOP AT NIH SHARING WEBSITE,
THAT I HAD IN THE LAST SLIDE.
AND IN THERE THEY HAVE SEVERAL
RESOURCES, GUIDANCE TO HELP
DEVELOPING THE DATA MANAGEMENT
SHARING PLAN, INCLUDING THE
RESOURCES.
FOR EXAMPLE, THEY HAVE SOME
GUIDANCE AND THE TOOLS TO HELP
TO ESTIMATE RESOURCES NEEDED IF
YOU ARE DEVELOPING OR WANT TO
SHARE IMAGING DATA.
ALSO, IN THE SECTION ABOUT DATA
REPOSITORIES PROVIDED A
COMPREHENSIVE MEETING AND
REPOSITORIES FOR DIFFERENT
DOMAINS.
AND THERE WE ACTUALLY HAVE FULL
REPOSITORY SUPPORTED BY NIBIB
THAT CURRENTLY LISTED ON THE
SHARING NIH.GOV THAT CAN SERVE
AS DOMAIN-SPECIFIC REPOSITORY
WHICH INCLUDING DATABASE
(INDISCERNIBLE) FOR SIGNAL DATA
AS WELL.
THOSE ARE THE RESOURCES THAT IS
ALREADY AVAILABLE AND ACTUALLY A
LONGTIME EFFORT OF NIBIB TO
DEVELOP THOSE RESOURCES THROUGH
R01 AND T41, IN ADDITION THESE
ARE JUST MINIMUM POLICY FOR
GENERAL ANNOUNCEMENT.
THERE COULD BE SPECIAL
ANNOUNCEMENTS, DEDICATED
ADDITIONAL RESOURCES FOR DATA
MANAGEMENT SHARING, BRIDGE TO
A.I., THE INITIATIVE, CO-MEETING
TO REALLY BOOSTING THE DATA
SHARING AND HEALTH CARE EQUITY
AND THERE MAY BE ADDITIONAL
INITIATIVES THAT COULD BE FOR
DATA AND SPECIFIC FOR THE DATA
MANAGEMENT AND SHARING IN THE
FUTURE.
>> THANK YOU.
MARYELLEN?
>> YES, FIRST I DID NOT SET UP
CYNTHIA TO ASK THAT QUESTION.
GREAT QUESTION, CONTACT US,
WE'LL WORK OUT.
BUT WHAT I WANTED TO SAY WITH
DATA SHARING IT CAN INCLUDE LIKE
THE TOOLS, THE SOFTWARE,
ALGORITHMS, THE ACTUAL DATA, AND
THE MACHINE INTELLIGENCE OUTPUT,
AND WITH THAT AS FOLKS EITHER
USED THEIR MACHINE INTELLIGENCE
AND SHARED DATA, THEIR DATA AND
MACHINE INTELLIGENCE ALGORITHM
OR OUTCOME, IT COULD FEED INTO
LOOKING AT BIAS AND HOW WE MIGHT
MITIGATE BIAS, YOU KNOW, IS THE
ALGORITHM THAT'S SHARED BIAS TO
ITS DATA WHEN YOU APPLY YOUR OWN
DATA FROM THAT SHARED RESOURCE
SO I THINK A LOT OF SECONDARY
USAGE WILL COME FROM THIS
POLICY, SO VERY SUPPORTIVE OF
IT.
>> THANK YOU.
>> GREAT.
THANK YOU SO MUCH.
ANY OTHER COMMENTS?
ZANE, I PRESUME YOUR HAND IS UP
FROM BEFORE.
DID YOU HAVE AN ADDITIONAL
REMARK?
>> MY HAND IS DOWN.
>> I WASN'T SURE IF YOU HAD
ANOTHER COMMENT.
HAPPY TO HEAR IT.
>> MAYBE I CAN KIND OF ADD SOME
CONNECTIONS BETWEEN A LOT OF THE
COMMENTS.
YOU KNOW, WE'RE SORT OF AT THIS
REALLY UNIQUE MOMENT IN TIME IN
TERMS OF DATA CREATION AND A LOT
OF THESE EFFORTS HAVE BEEN
DRIVEN BY THE MORE TRADITIONAL
BIOLOGY COMMUNITIES THAT IN
PARTICULAR GENOMICS WHERE
THERE'S BEEN HUGE SUCCESS IN
SHARING DATABASES FOR REUSE AND
CONTINUED DISCOVERY SO THERE'S
SUBSTANTIAL RETURN ON
INVESTMENT.
AND I THINK IT'S UP TO OUR
COMMUNITY TO PICK SOME CASES, IF
WE DO WANT -- IT IS A VERY
EXPENSIVE TO HAVE REPOSITORIES,
AND IN A SENSE WHAT THIS GUIDE
A NCE IS YOU NEED TO HAVE A PLAN
FOR DATA SHARING.
WE'RE NOT DICTATING YOUR PLAN
BUT YOU NEED TO BE THINKING
ABOUT IT AND ADDRESSING IT.
I THINK IT'S UP TO YOU GUYS TO
DEMONSTRATE THE VALUE OF WHEN
SHARING CAN DRIVE NEW DISCOVERY
AND DATA CAN BE REUSED IN
DIFFERENT WAYS ACROSS TIME.
AND THAT'S A BIG CHALLENGE
BECAUSE IF WE CAN'T REALLY SHOW
THAT, THEN IT'S VERY HARD TO
JUSTIFY FUNDING CONTINUED GROWTH
OF REPOSITORIES IF PEOPLE AREN'T
REALLY TRULY ACCESSING THEM AND
MAKING IMPORTANT NEW DISCOVERIES
THAT ARE BASED ON THEM.
SO, JUST IN TERMS OF
INVESTMENTS, INSTITUTES ARE LESS
LIKELY TO INVEST IN THOSE AS
OPPOSED TO CONTINUED GENERATION
OF NEW DATA SOURCES COMING FROM
NEW INNOVATIONS.
SO, THIS IS A CHALLENGE FOR OUR
COMMUNITY TO BRING SOME HIGH
PROFILE EXAMPLE CASES TO THE
FOREFRONT, AND THEN FROM A
TECHNICAL PERSPECTIVE IT STRIKES
ME THAT WE'RE FAIRLY INEFFICIENT
IN TERMS OF HOW WE BUILD DATA
REPOSITORIES, THE STRUCTURES,
AND OFTENTIMES, YOU KNOW, THE
KIND OF STATE OF THE ART
APPROACHES FOR DATA COMPRESSION
AND FOR MINIMIZATION OF
INFORMATION CONTENT TO ESSENTIAL
INFORMATION CONTENT MAY NOT BE
UTILIZED BY CERTAINLY THE
MORE -- THE BROADER BIOLOGY
COMMUNITY, AND MAYBE SOME
EXAMPLES OF WHAT WE DO IN THE
ENGINEERING AND PHYSICAL SCIENCE
COMMUNITY COULD INFLUENCE WHAT'S
GOING ON AT THE REST OF THE NIH.
SO I'M EAGER TO HEAR YOUR
THOUGHTS ABOUT THOSE APPROACHES
AS WELL.
AND WHETHER OR NOT THAT MAY HELP
US KEEP OR CONTAIN SOME OF THE
COSTS OF BUILDING THESE GIANT
REPOSITORIES.
>> THANKS, BRUCE.
ZANE?
>> BRUCE, THANKS FOR THOSE
COMMENTS.
I GUESS THE QUESTION I HAVE, IS
THERE ANY MEANS BY WHICH THROUGH
RETRO ANALYSIS OF SOME OF THE
WORK THAT'S BEEN DONE IN THE
PAST, WHERE STUDIES HAVE HAD TO
REPRODUCE DATA, I THINK WITH THE
A.I. AND M.L. EFFORTS THERE'S A
LOT OF WE'RE TRYING TO DEVELOP
SO WE DON'T DUPLICATE.
DO WE HAVE A BUSINESS CASE
ALREADY BUILT IN THIS SPACE?
A.I. AND M.L. AND THINGS
PUBLISHED IN THE PAST WHERE WE
SEE DUPLICATION OF EFFORT, YOU
KNOW, ADDITIONAL COST ASSOCIATED
WITH THE FACT DATA WASN'T
AVAILABLE?
>> I'M REALLY INTERESTED IN ALL
OF YOUR THOUGHTS ON THAT ONE
BECAUSE IT'S VERY HARD, I THINK
WE CAN POINT TO SEVERAL
EXAMPLES, PARTICULARLY IN THE
GENOMICS AND IN THE WHOLE
DISCOVERY OF THINGS LIKE
EPIGENETIC CLOCKS WHICH WAS ALL
DRIVEN BY PUBLICLY AVAILABLE
SHARED DATABASES.
BUT I'D LIKE TO SEE US DO A
BETTER JOB AS A COMMUNITY OF
SHOWING THE VALUE OF THE SHARED
DATA, MIDRC IS DOING IT RIGHT
NOW, AND BUILDING IT FROM THE
GROUND FLOOR SO THIS IS KIND OF
AN EXPERIMENT THAT MANY PEOPLE
ACROSS THE NIH ARE NOW WATCHING,
FROM THE IMAGING COMMUNITY, AND
SO THERE'S GOT TO BE MORE COMING
IN THIS SPACE.
>> WE CAN TALK OFFLINE, BRUCE.
>> YEAH.
A LONG DISCUSSION.
>> YEAH.
>> THANK YOU, ZANE.
MARYELLEN?
>> I'LL BE SHORT BUT I THINK
IT'S REALLY IMPORTANT, SINCE
THIS IS MY LAST MEETING I HAVE
TO GET MY WORDS IN.
I APPRECIATE BRUCE MENTIONING
MIDRC BECAUSE I'VE DONE A LOT OF
A.I. WORK IN THE LAB, YOU HAVE A
GREAT DATASET, ANNOTATED, AN
EXCEL FILE, YOU SAY, I HAVE A
GREAT DATABASE.
BUT TO USE IT AND TO REALLY
NAVIGATE WHERE ALL THE IMAGES
ARE AND TO PUT IT AT SCALE,
PEOPLE HAVE A LOT OF GOOD
DATASETS, BUT TO MOVE IT TO AT
SCALE, WHERE MIDRC IS,
THERE'S -- I'VE LEARNED A LOT.
HOW DO YOU SHARE THE DATA?
THERE'S USER AGREEMENTS.
CONTRIBUTING AGREEMENTS.
THE WHOLE AREA OF POLICY, AND
THEN WHAT ARE THE DATA ELEMENTS
ON WHICH YOU CAN SEARCH YOUR
DATA SO YOU CAN REUSE IT?
COLLECTED FOR ONE THING BUT YOU
HAVE TO SLICE AND DICE FOR
ANOTHER REUSE CASE IS A WHOLE
BIG DISCUSSION SO THAT YOU
ENABLE THAT COHORT BUILDING.
THERE'S ASPECTS OF JUST THE
RESEARCH OF USING IT AND HOW TO
USE IT APPROPRIATELY, WHAT
METRICS TO USE, HOW TO HANDLE
BIASES, AND THEN FOR THE
TRANSLATION PART HOW DO YOU
EXPEDITE TRANSLATION, WE DO THAT
WITH SEQUESTERING DATASET, BUT
THERE'S A LOT OF ASPECTS
INCLUDING CURATION AND USER
INTERFACE WHEN YOU MOVE A
DATASET AT SCALE TO TAKE IN ALL
THESE OTHER DATA SHARING
CONTRIBUTIONS, IT'S A WHOLE
OTHER BALL GAME THAN A DATASET
IN YOUR LAB.
A HUNDRED OF US HAVE LEARNED A
LOT IN THE PAST TWO YEARS.
>> YEAH, I THINK THE SUMMARY TO
ALL OF THAT IS THAT, YOU KNOW,
YOU'RE SHARING -- THOSE NOT A
POLICY THAT'S REQUIRING
EVERYBODY TO SHARE EVERYTHING
ALL THE TIME.
I THINK A COMMON DISCUSSION AT
THE NIH IS PARTICULARLY IN
BIOLOGY LABS, IS, HEY, WE WANT
EVERYBODY EVERY BIT OF DATA TO
BE SHARED, EVEN FAILED
EXPERIMENTS.
AND THAT'S NOT NECESSARILY IN
OUR CULTURE, YOU KNOW, AS QI
POINTED OUT FROM BIOLOGY DRIVEN
VERSUS TECHNOLOGY RESEARCH,
MAYBE THINGS THAT GO ON IN OUR
COMMUNITY ARE TECHNOLOGY DRIVEN
AND FAILED EXPERIMENTS ARE
TECHNOLOGIES THAT YOU JUST --
THEY SEEMED LIKE A GOOD IDEA, NO
ONE IS GOING TO PURSUE THEM.
SOMETIMES THEY TEND TO GET
COMMUNICATED OR SHARED THROUGH
PRESENTATIONS BY TRAINEES,
CONFERENCES WHO SAY WE TRIED
THIS, TRIED THIS, TRIED THIS.
SO WE HAVE TO THINK LOGICALLY
ABOUT THE SCALE OF THE PROBLEM
AND THE OPPORTUNITIES, MIDRC IS
AN AMAZING EXAMPLE OF THE KIND
OF HUGE IMPACT THAT WE CAN HAVE
IN SHARING THAT IS IMMEDIATELY
UNDERSTANDABLE BY THE SORT OF
MAINSTREAM BIOLOGY, BIOMEDICAL
COMMUNITY BUT WE DON'T WANT TO
BE WEDGED INTO THAT MODEL FOR
EVERYBODY'S RESEARCH, EVERY R01,
AND IT NEEDS TO BE APPROPRIATE
GIVEN THE SCALE AND THE SIZE OF
THE WORK AND THE AMBITION.
>> THANK YOU.
ANY OTHER FINAL COMMENTS?
BRUCE, WOULD YOU LIKE TO MOVE TO
THE NEXT SEGMENT?
>> YES, AND WE REALLY TEED THIS
UP WITH STEPHANIE AND LUISA, I
THINK WITH OUR RADxIFICATION
DISCUSSION, AND THEY ARE THE
SOFTWARE MATERIALS EXPERTS, A
TERRIFIC INNOVATIVE IDEA TO
SHARE WITH ALL OF YOU.
STEPHANIE AND LUISA, TAKE IT
AWAY.
>> THANK YOU, BRUCE.
LIT LET ME SHARE MY SCREEN.
YOU SHOULD BE ABLE TO SEE THE
TITLE SLIDE FOR TODAY'S
PRESENTATION.
OKAY.
AGAIN, THANK YOU FOR THE
INTRODUCTION.
I'M HERE TO PRESENT A CONCEPT ON
BEHALF OF THE DIVISION OF
DISCOVERY SCIENCE AND
TECHNOLOGY, DDST.
I'M STEPHANIE MORRIS, I WAS
RECENTLY ON A PART TIME DETAIL
WITHIN THIS DIVISION FOR EIGHT
MONTHS, MY HOME BASE ACTUALLY IS
HUMAN GENOME RESEARCH INSTITUTE
WHERE I'M A PROGRAM DIRECTOR,
MANAGING EFFORTS IN TECHNOLOGY
DEVELOPMENT AND FUNCTIONAL
GENOMICS.
YOU'LL HEAR FROM ME AND LUISA
RUSSELL, PROGRAM DIRECTOR IN
DDST, WE'VE BEEN WORKING
TOGETHER ON THIS PROGRAM CONCEPT
OVER THE PAST SEVERAL MONTHS,
ALONG WITH THE DIRECTOR, IT'S
BEEN A FANTASTIC OPPORTUNITY TO
WORK WITH THEM.
SO THE TENTATIVE LONG HAND NAME
FOR THE PROGRAM IS BIOMATERIALS
TECHNOLOGY RESOURCE AND
INTEGRATION NETWORK.
AND THAT NAME IS THERE BECAUSE
WE WANT TO BE CONSISTENT WITH
THE NAMING CONVENTION OF OTHER
NETWORKS SUPPORTED BY NIBIB.
WE'RE CALLING IT THE
BIOMATERIALS NETWORK, FOR SHORT.
RATIONALE FOR WHY THIS IS
BROUGHT TO YOU TODAY, THIS IS
REALLY ABOUT BROADLY ADDRESSING
CHALLENGES TO TECHNOLOGY
TRANSLATION HOMING IN ON
BIOMATERIALS IN PARTICULAR.
IT'S BEEN A WONDERFUL MORNING,
SO FAR, TEEING UP FOR THIS
PRESENTATION.
SO, AS YOU KNOW, THE ITERATIVE
PROCESS CAN AFFECT DESIGN AND
PROGRESS OF DEVELOPMENT.
GOING FROM INNOVATIVE IDEA TO
CLINICAL APPLICATION IS NOT
TRIVIAL.
TIME AND PATHWAY TO GET TO THE
CLINIC IS COMPLEX, EXTENSIVE,
DEVELOPERS ENCOUNTER HURDLES CAN
RESULT IN TECHNOLOGIES
LANGUISHING IN THE VALLEY OF
DEATH.
THINGS LIKE REPRODUCIBILITY,
VALIDATION, NEED FOR THAT.
MATCHING AND TECHNOLOGY
CAPABILITIES WITH MARKET AND
CLINICAL NEED.
HAVING A SUPPORTIVE ACADEMIC
INSTITUTION AND IN GENERAL
HAVING SUPPORTIVE DIFFERENT
STAGES OF DEVELOPMENT.
IMPORTANCE OF INTELLECTUAL
PROPERTY CONSIDERATION,
DEVELOPING COLLABORATIONS AS
WELL AS TIMING, RISK, COST.
FOR THIS PROGRAM, IT'S FOCUSED
ON PROVIDING SUPPORT TO HELP
NIBIB TECH DEVELOPMENTS TRAVERSE
VALLEY OF DEATH TO GET TO POINT
OF ADOPTION OF TECHNOLOGY,
DISSEMINATION TO BROADER
COMMUNITY.
WHY DO WE NEED BIOMATERIALS
NETWORK?
BIOMATERIALS ARE SUPPORTED
ACROSS THE NIH, AT STAGES WHERE
THEY FIT THE MISSION.
WHAT WE DO NEED IS TO REDUCE
NUMBER OF ISSUES THAT DEVELOPERS
ENCOUNTER IN PROJECTS BY
ADDRESSING EARLY STAGES NEW
BIOMATERIALS TECHNOLOGY
DEVELOPMENT.
THIS WOULD BE DURING THE STAGES
OF DEVELOPMENT PRIOR TO WHEN
THEY START TO TARGET SPECIFIC
APPLICATIONS AND PROBLEMS.
OUR EXAMPLE, CASE STUDY FOR
BIOMATERIALS IS BIOMATERIALS
SPACE THERAPEUTICS, RECENT
REVIEW EXAMINED WHY SOME
MEDICINES FAIL TO BE TRANSLATED,
IDENTIFIED THREE BOTTLENECKS
THAT CAN PREVENT CROSSING VALLEY
OF DEATH, THESE ARE SCIENCE,
MARKET, CLINIC.
TAKING A QUICK LOOK AT EACH,
THERE ARE SEVERAL CHALLENGES
THAT CROP UP NOT LIMITED TO
NANOMEDICINES OR THERAPEUTICS.
IN SCIENCE, UNDERSTANDING
MATERIALS WITH BIOLOGICAL
TISSUES, CHALLENGES TO
MANUFACTURING, THINKING ABOUT
THE SCALING UP PROCESS, MATERIAL
SAFETY ISSUES, IN CLINIC
DIFFICULTY IN SECURING FUNDS.
WE'RE DESIGNING TO ADDRESS
BOTTLENECKS, NOT ABOUT HAVING
RESOURCES BUT HAVING THE RIGHT
RESOURCES AT THE RIGHT TIME WITH
SPECIFIC SUPPORT ALONG EACH STEP
OF THE PATH BENCH TO BEDSIDE.
MOVING ALONG WITH THIS NETWORK
WE'RE PREPARING TO SUPPORT
ENGINEERING OF BIOMATERIALS IN A
DIFFERENT WAY THAN SEEN IN OTHER
I.C.s.
CURRENT MODEL LARGELY IN USE AT
NIBIB, ACROSS NIH, BIOLOGICAL
FOR BIOMATERIALS SUPPORTED
ACROSS NIH ARE AT THE STAGE
WHERE MAJORITY ARE WELL ACCEPTED
TOOLS, BIOMATERIALS, AND
TAILORED TO CERTAIN CLINICAL
APPLICATIONS, RESPONSIVE TO
MISSION OF THAT INSTITUTE,
PRIMED TO ADDRESS SPECIFIC
PROBLEMS.
AT NIBIB WE'RE FOCUSED ON NOVEL
CLASSES WITH BROAD APPLICABILITY
ACROSS CLINICAL AREAS, EARLY
STAGES PRIOR TO TAILORING PHASE.
THE INTENTION OF THE
BIOMATERIALS NETWORK IS TO
PROVIDE NIBIB BIOMATERIALS TECH
DEVELOPERS ACCESS TO EXPERTISE
AND SUPPORT ALONG THE
DEVELOPMENT PIPELINE TO REALLY
HONE CAPABILITIES OF THESE
TECHNOLOGIES AND ACCELERATE
TRANSLATION.
WE WANT TO POINT OUT THAT THIS
PROGRAM IS BUILDING UPON AND
LEVERAGING ACCEPTANCE OF SOME
TECHNOLOGY DEVELOPMENT PROGRAMS
HERE AT NIH, LIKE POCTRN, NIH'S
MICROANALYSIS AND TECHNOLOGIES
PROGRAM, AND GENOME TECHNOLOGY
PROGRAM.
SO THERE ARE THREE GOALS FOR
THIS NETWORK THAT WE WANT TO
HIGHLIGHT TODAY.
THAT INCLUDES DEVELOPING A
PIPELINE OF BIOMATERIALS, WE
WANT THIS TO PROVIDE EXPERTISE
IN RESOURCES TO PROVIDE
FOUNDATION TO OVERCOME FUTURE
IMPLEMENTATION.
AND LASTLY, WE WANT TO ENABLE
TARGETED COLLABORATIONS TO
ENHANCE TECHNOLOGY DEVELOPMENT.
THIS WOULD BE WITHIN THE NETWORK
AND ACROSS NIH AT EARLY AND
ADVANCED STAGES.
I'LL STOP HERE AND TURN IT OVER
TO LUISA TO TALK MORE ABOUT THE
ACTUAL CONCEPT AND DETAILS.
>> ALL RIGHT.
THANK YOU, STEPHANIE.
OVERALL CONCEPT IS TO BUILD A
FRAMEWORK AROUND THE EXCITING
WORK IN THE DDST BIOMATERIALS
PORTFOLIO.
WHAT MAKES THIS DIFFERENT IS
THAT WE'RE MEETING P.I.s WHERE
THEY ARE IN THE EARLY STAGES OF
TECHNOLOGY DEVELOPMENT WHERE
PEOPLE OFTEN DON'T HAVE THE
PARTNERSHIPS OR RESOURCES TO
ADDRESS LATE STAGE CONCERNS THEY
WOULD BENEFIT FROM CONSIDERING
EARLIER.
BASICALLY WE'RE TAKING NOVEL
BIOMATERIALS AT NIBIB AND MAKING
SURE WHEN WE FUND DEVELOPMENT WE
GET MORE SUCCESS OUT OF WHAT IS
PROPOSED BECAUSE THE P.I.s
WILL HAVE ACCESS TO THE RIGHT
RESOURCES AT THE RIGHT TIMES.
TO ACCOMPLISH THAT WE PROPOSE
SET OF SUPPORTING NETWORK
CENTERS ALONGSIDE TECHNOLOGY
DRIVEN PROJECTS, I'LL JUMP INTO
THE DETAILS OF EACH OF THESE
COMPONENTS NOW.
THE NEXT WORK CENTERS INCLUDE
TECHNOLOGY COORDINATION CENTER
AND TECHNOLOGY RESOURCES CENTER,
AND THESE ARE DESIGNED TO WORK
TOGETHER TO SUPPORT DESIGN AND
TRANSLATIONAL NEEDS OF THE
TECHNOLOGY DEVELOPMENT PROJECTS.
TECHNOLOGY COORDINATION AND
INTEGRATION CENTERS FOCUSES ON
EFFORTS SUPPORTED BY THE
NETWORK.
TECHNOLOGY RESOURCES CENTER WILL
AID IN TECHNOLOGY DEVELOPMENT
PROCESS BY PROVIDING EXPERTISE
AND RESOURCES TO ADDRESS
BARRIERS TO TECHNOLOGY
DISSEMINATION AND TRANSLATION.
BOTH CENTERS WILL WORK TOGETHER
TO PROVIDE OPPORTUNITIES FOR
PARTNERING, COORDINATION SUCH AS
ENTREPRENEURIAL TRAINING,
TECHNICAL COMMERCIALIZATION AND
TRANSLATIONAL EXPERTISE AND
RESOURCES.
IMPORTANTLY, THEY WILL PROVIDE
ACCESS TO OPPORTUNITY FUNDS IN
RESPONSE TO DESIGN, CLINICAL,
TECHNICAL NEEDS IDENTIFIED IN
THE CENTER'S ASSESSMENT OF
TECHNOLOGIES.
WE PROPOSE TWO TO BE SUPPORTED,
EXPLORATORY AND PROTOTYPING.
EXPLORATORIES ARE PROOF OF
PRINCIPLES EARLY STAGE
ENGINEERING PROJECTS, FOCUSING
ON DEVELOPMENT OF EMERGING
BIOMATERIALS TECHNOLOGIES.
SINCE THE BIOMATERIALS PORTFOLIO
AT NIBIB IS DISEASE AND PLATFORM
AGNOSTIC THESE COULD INCLUDE
NOVEL VARIATIONS ON EXISTING
MATERIALS CLASSES TO EXPLORATION
OF BIOMEDICAL OR PERSONALIZED
DELIVERY SYSTEMS.
ON THE OTHER HAND THE
PROTOTYPING PROJECT DESIGNS
BIOMEDICAL PROOF-OF-CONCEPT
THROUGH EARLY STAGE VALIDATION,
INCLUDING PROJECTS FOCUSED ON
DEVELOPMENT OF NOVEL BIOMEDICAL
PLATFORMS BASED ON CLASSES THAT
EXIST OR HAVE BEEN DEVELOPED
THROUGH THE EXPLORATORY PROJECT.
BOTH EXPLORATORY AND PROTOTYPING
PROJECTS ARE DESIGNED TO BE
MILESTONE DRIVEN WORKING WITH
CENTRAL RESOURCES.
WE PLAN TO LEVERAGE R21 AND
R01s, BOTH EXPLORATORY AND
PROTOTYPING PROJECTS ARE
DIFFERENT FROM THE PARENT R01,
R21, R21 TRAILBLAZER WE SUPPORT
BECAUSE OF THEIR HIGH LEVEL OF
INTEGRATION WITH SCIENTIFIC,
CLINICAL, MARKET-BASED RESOURCES
EARLY ON IN DEVELOPMENT AS WELL
AS ADDITION OF MILESTONING TO
ENSURE PROGRESS.
ALL OF THESE NETWORK COMPONENTS
HAVE BEEN DESIGNED TO WORK
TOGETHER TO ADDRESS GAPS FOR
TRANSLATION OF BIOMATERIALS.
NEXT SLIDE PLEASE.
KEY FEATURE IS THIS INTERACTION
BETWEEN CENTERS AND PROJECTS.
THE NETWORK CENTER SHOULD
PROVIDE RESOURCES INCLUDING
SCIENTIFIC, CLINICAL,
REGULATORY, MARKET BASED
CONSULTANTS AS WELL AS RESOURCES
IN MODELING, EDUCATION AND
DESIGN.
CENTERS WILL IDENTIFY AND BUILD
PARTNERSHIPS TO BENEFIT
DEVELOPMENT OF TECHNOLOGIES IN
THE EXPLORATORY AND PROTOTYPING
PROJECTS.
IN ADDITION, CENTERS WILL BE
RESPONSIBLE FOR ASSESSING
TECHNOLOGY DEVELOPMENT PROJECTS
FOR NEEDS AND UTILIZATION OF
RESOURCES, AND WHEN STUDIES ARE
RECOMMENDED THAT WERE NOT
PROPOSED OR BUDGETED FOR NETWORK
CENTERS WILL HAVE ABILITY TO
SOLICIT AND ADMINISTER
OPPORTUNITY FUNDS INCLUDING USE
OF INDUSTRY STANDARDS,
VALIDATION STUDS THROUGH
PARTNERSHIPS.
TECHNOLOGY DEVELOPMENT PROJECT
ARE REQUIRED TO WORK WITH THE
CENTERS, WITH ABILITY TO TAKE
ADVANTAGE OF TECHNICAL,
TRANSLATIONAL, COMMERCIALIZATION
CONSULTANTS AS NEEDED AS WELL AS
AFOREMENTIONED RESOURCE.
NOT ONLY THAT BUT BOTH
EXPLORATORY AND PROTOTYPING
PROJECTS ARE SUBJECT TO NEEDS
ASSESSMENT BY CENTERS OF REGULAR
INTERVALS ENSURING THEY TAKE
ADVANTAGE OF RESOURCES AVAILABLE
APPROPRIATE TO THE STAGE THEY
ARE AT..
BOTH CENTERS AND TECHNOLOGY
DEVELOPMENT PROJECTS WILL ATTEND
ANNUAL P.I. MEETING AND AD HOC
WORKSHOPS ARRANGED IN RESPONSE
TO THE NEEDS OF TECHNOLOGY
DEVELOPMENT PROJECT.
EVERY COMPONENT IS DESIGNED TO
INTERACT WITH NIBIB PROGRAM
STAFF.
NEXT SLIDE PLEASE.
PERFECT.
ANOTHER IMPORTANT ASPECT IS
ENABLING OF PARTNERSHIPS, AND
THIS IS SOMETHING WE HOPE TO
LEVERAGE IN MULTIPLE WAYS TO FIT
NEEDS OF FELLOW INSTITUTES.
BIOMATERIALS RELATED WORK EXISTS
AT MANY INSTITUTES BUT IN
GENERAL CAN BE DIFFICULT TO
BRING NOVEL BIOMATERIALS TYPES
TO INSTITUTES THAT FOCUS ON
CLINICAL CONCERNS, WE HOPE TO
LEVERAGE STRUCTURE TO BUILD
STRONGER BRIDGES BETWEEN THE
NOVEL BIOMATERIALS PLATFORMS WE
DEVELOP AND CLINICAL FOCI OF
DISEASE SPECIFIC INSTITUTES FOR
A PATHWAY INTO PROGRAMS THAT
EXIST AT PARTNER INSTITUTES.
WE CAN ACCOMMODATE EARLY STAGE
PARTNERSHIPS THROUGH MECHANISMS
FOR EXPLORATION OF NOVEL TARGETS
ADDRESSED THROUGH CREATION OF
PLATFORMS.
WE CAN ALSO LEVERAGE
TRANSLATIONAL BIPHASIC
MECHANISMS FOR THE PROTOTYPING
PHASE, PARTNERSHIPS CAN INCLUDE
LATE STAGE CHARACTERIZATION,
OPTIMIZATION TO NEEDS OF A
PARTICULAR DISEASE OR CLINICAL
INDICATION.
THIS GIVES ABILITY TO ADDRESS
VARIETY OF NEEDS INSTITUTES MAY
HAVE BUILDING STRONG CROSS-NIH
BRIDGES FOR BIOMATERIALS,
SHOWING FLEXIBILITY OF
INFRASTRUCTURE TO COVER THE
NEEDS OF THE FIELD OF
BIOMATERIALS BUT LEVERAGED FOR
OTHER PURPOSES AND APPLIED IN
THE FUTURE TO OTHER ENGINEERING
FIELDS WE SUPPORT AT NIBIB SUCH
AS SYNTHETIC BIOLOGY.
NEXT SLIDE PLEASE.
TO WRAP UP, WE'VE PRESENTED
BIOMATERIALS NETWORK CONCEPT
DESIGNED TO BUILD STRONGER
FOUNDATION UNDER EXCITING
BIOMATERIALS WORK OUR P.I.s
PROPOSE, USING NOVEL SUPPORT
FRAMEWORK BASED ON SUCCESSFUL
TECHNOLOGY DEVELOPMENT PROGRAMS,
CUSTOMIZED FOR NEEDS OF NIBIB
BIOMATERIALS P.I.s, WE HEAP
HOPE TO REREINFORCEMENT BRINGING
MORE NIBIB SOLUTIONS
SUCCESSFULLY FROM THE BENCH TO
BEDSIDE, AND WITH THAT WE THANK
YOU FOR YOUR TIME AND WE'LL TAKE
ANY QUESTIONS AND DISCUSSION YOU
MAY HAVE.
THANK YOU.
>> THANK YOU.
ANY COMMENTS OR QUESTIONS FROM
THE COUNCIL MEMBERS?
I SEE JOYCE.
>> YES, THANK YOU, STEPHANIE AND
LUISA.
MUCH NEEDED.
IT'S GREAT SEEING CONNECTION TO
THE OTHER INSTITUTES AT NIH.
WONDERING HOW MUCH INTERACTION
THERE ARE WITH OTHER FEDERAL
AGENCIES NAMELY LET'S SAY FDA
THINKING ABOUT LIKE 510(K) TO
ACCELERATE IF YOU HAVE LIKE
EXISTING MATERIALS, FOR EXAMPLE,
I'M A GRADUATE OF THE I-CORPS
PROGRAM, A GREAT OPPORTUNITY FOR
INDUSTRY PARTNERSHIPS AND ALSO
YOU MENTIONED STANDARDS SO NIST,
THERE'S A LOT OF GREAT
OPPORTUNITIES, I'M CURIOUS IF
YOU'VE BEEN TALKING TO THEM AS
WELL.
>> I THINK IN GENERAL AT NIBIB
THERE ARE CONVERSATIONS WITH
PEOPLE AT NSF, LIKELY NIST, AND
THE FDA, AND I THINK THAT'S
SOMETHING THAT WE WOULD LOOK FOR
OPPORTUNITIES TO PARTNER THROUGH
THE CENTERS THAT ARE PROVIDING
RESOURCES AND COORDINATION, THAT
MOST CERTAINLY WOULD BE OF
INTEREST.
AND LUISA, YOU'VE BEEN HAVING
CONVERSATIONS WITH NSF.
>> YEAH, DEFINITELY.
I AGREE.
THAT'S ONE OF THE EXCITING
THINGS, ABILITY TO BUILD WITH
EXISTING RESOURCES TO MAKE SURE
PEOPLE ARE TAKING ADVANTAGE,
SOMETHING THE CENTERS WILL HAVE
THE ABILITY TO DO SO THEY WILL
BE ON THE GROUND WITH TECHNOLOGY
DEVELOPMENT PROJECT.
WE ARE OF COURSE HAVING
DISCUSSIONS WITH OTHER AGENCIES
AS WELL.
I THINK AT THE NSF WE'RE TALKING
ABOUT THINGS FROM A BASIC
BIOMATERIALS PERSPECTIVE WHICH
WE'RE EXCITED ABOUT BUT OF
COURSE THERE ARE OTHER
CONVERSATIONS GOING ON AS WELL.
THANK YOU.
>> THANK YOU.
GILDA AND TEJAL.
>> THANK YOU.
MY COMPLIMENTS TO WHAT YOU'VE
DONE SO FAR.
NOT TO DIMINISH EXCITEMENT BUT
WHAT I FIND IS WHEN YOU TRY TO
GET NETWORKS TOGETHER AND GET
PEOPLE WRAPPED UP, THEY GET ALL
EXCITED BUT THEN SOMETIMES THEY
PETER OUT.
I'M JUST WONDERING IF THERE'S
BEEN SOME CONVERSATION AT THIS
POINT ABOUT SUSTAINING THE
INTEREST AND ENERGY AND
EXCITEMENT, HOW DO YOU SUSTAIN
THIS TYPE OF ACTIVITY?
NOT JUST SCALING IT BUT HOW DO
YOU SUSTAIN IT?
>> OH, THAT'S THE THING ABOUT
DEVELOPING CENTERS COORDINATING
AND PROVIDING RESOURCES, THEY
HAVE TO HAVE REGULAR
INTERACTIONS WITH THE GRANTEES.
SO, YOU CAN HAVE AN ANNUAL
MEETING BUT THERE'S THE
ASSESSMENT PORTION, ASSESSING
TECHNOLOGIES, PROBABLY ONCE OR
TWICE DURING THE AWARD PERIOD,
MORE SO OPPORTUNITIES TO HAVE
THE GRANTEES COME TOGETHER,
INTERACT BY WORKSHOPS OR WORKING
GROUPS AS NEEDED.
I'VE SEEN THAT AS A WAY TO
SUSTAIN EXCITEMENT, IT WORKS
WELL WITH OPPORTUNITY TO
INTERACT BEYOND AN ANNUAL
MEETING, SOMETHING YOU CAN DO
WITH THE CENTER APPROACHES,
BUILDING THAT IN, TRYING TO HAVE
MORE INTERACTION, MAINTAINING
THE DISCUSSION AROUND THE
TECHNOLOGIES AND WHERE THEY ARE
IN TERMS OF THEIR PROGRESS.
>> SOUNDS GOOD.
GOOD LUCK.
>> THANK YOU.
>> TEJAL?
>> WE CAN'T HEAR YOU.
>> YOU'RE MUTED, TEJAL.
>> CAN YOU HEAR ME NOW?
>> YES.
PERHAPS I SHOULD HAVE SAID
JASON, MAYBE THAT WOULD HAVE
CAUGHT YOUR ATTENTION.
>> THANK YOU FOR DOING THIS.
I THINK AGAIN AS SOMEBODY WHO
WORKS IN THE BIOMATERIALS FIELD
THIS IS MUCH NEEDED AND REALLY
THERE HAVE BEEN A NUMBER OF
CHALLENGES IN TERMS OF REALLY
ACCELERATING THE PACE OF
TECHNOLOGY.
ONE OF MY QUESTIONS, YOU SORT OF
TOUCHED ON THIS BRIEFLY, IS
PARTNERSHIPS WITH PHARMA AND THE
MEDICAL DEVICE INDUSTRY.
BECAUSE I THINK ONE OF MAYBE THE
DIFFERENCES BETWEEN THIS FIELD
IN PARTICULAR VERSUS MAYBE POINT
OF CARE DIAGNOSTICS OR OTHER
TYPES OF HARD TECHNOLOGIES IS
THAT SO MUCH OF WHAT DRIVES
APPLICATION AND DEVELOPMENT
REALLY IS CENTERED AROUND SORT
OF DEVELOPMENT EITHER WITHIN THE
PHARMACEUTICAL SECTOR OR MEDICAL
DEVICE SECTOR.
SO IS THERE A WAY TO ENGAGE
THOSE STAKEHOLDERS EARLY ON SUCH
THAT THEY FEEL LIKE THEY ARE
BOTH VESTED IN THE OUTCOMES OF
THE PROGRAM BUT ALSO CAN HELP
SHAPE SOME OF THE FOCUS AREAS AS
WELL?
>> LIKELY SO.
ONE PART OF WHAT WE WANT IS
ACTUALLY TO FACILITATE
PARTNERSHIPS AND INTERACTIONS
WITH CONSULTANTS, HOW TO HAVE A
CHANCE TO SEE SOME TECHNOLOGIES
AT SOME EARLIER STAGES.
DOING SOME SORT OF MARKET
ANALYSIS AND ALSO THINKING ABOUT
REGULATORY CONSIDERATIONS EARLY
ON TO START THINKING ABOUT WHAT
IS OF INTEREST WHEN YOU GET
FURTHER ALONG TO THE CLINICAL
STAGES SO YOU CAN THINK ABOUT
THAT IN THE EARLY TECHNOLOGY
DEVELOPMENT.
YEAH, SO IT'S SOMETHING THAT'S
SORELY NEEDED.
YOU DON'T WANT TO GET SO
ADVANCED YOU'RE AT A POINT WHERE
YOU'RE NOT NECESSARILY
DEVELOPING SOMETHING THAT'S
APPROPRIATE MOVING FORWARD AND I
THINK WE'VE SEEN THAT HAPPEN.
>> IT HAPPENS QUITE COMMONLY.
>> JOYCE AGAIN?
>> YES, TO FULL UP, ANOTHER
EARLY STAKEHOLDER IS THE PAYORS,
LIKE INSURANCE COMPANIES, A LOT
OF US HAVE BEEN THERE WHERE YOU
END UP MAKING SOMETHING WHERE
IT'S NOT GOING TO BE
REIMBURSED, THAT'S CRITICAL TO
HAVE THEM AS A KEY STAKEHOLDER
AS WELL.
>> THANK YOU FOR POINTING THAT
OUT.
THAT'S COME UP, FOR CERTAIN.
>> ANY OTHER COMMENTS?
>> I DIDN'T PUT MY HAND UP,
MAYBE I COULD JUMP IN.
THESE ARE EXCELLENT COMMENTS
THAT I THINK GO TO EXACTLY WHAT
WE'VE DONE WITH RADx UNDER THE
PRESSURE OF A PANDEMIC AND A
VERY FOCUSED PROBLEM TO SOLVE.
AND WE'RE MEETING -- JILL AND I
MEET WEEKLY WITH CMS.
WE MEET WITH FDA OF COURSE AND
CDC.
AND WE HAVE OUR ARGUMENTS,
ESPECIALLY WITH CDC.
BUT IN THE END WE'VE REALLY
HELPED CHANGE THEIR SET POINT
AND THEIR EXPECTATIONS.
WHEN WE STARTED THEY FELT LIKE
LABORATORY TESTS WERE THE GOLD
STANDARD, NOBODY SHOULD BE OR
NEEDED TO DO TESTS AT HOME.
THAT WAS THE CLASSIC
LABORATORYIAN PERSPECTIVE AND
NOW THEY ACKNOWLEDGE OVER OVER
THE COUNTER TESTS HAVE BEEN
TRANSFORMATIONAL MANAGING THE
PANDEMIC, WE'RE HOPING TO BRING
THESE INTO THE MATERIALS SIDE
BUT WE NEED USE CASES.
BECAUSE IT'S GOING TO BE THE USE
CASES THAT ALLOW US TO DRIVE
FORWARD THE CONSORTIA, BEGIN TO
DE-RISK SOME APPROACHES, AND
THAT WILL BE THE MODEL THAT WE
USE FOR THE NEXT ONE AND THE
NEXT ONE.
SO, I OFTEN THINK OF SAM, MY
COLLEAGUE SAM, AND FDG-PET AND
SIMON BECAUSE THE WAY THAT THAT
COMMUNITY, YOU KNOW, RALLIED
AROUND FDG AS A CONTRAST AGENT
PUSHED THAT PARTICULAR IMAGING
TECHNOLOGY THROUGH AND ACROSS
THE FINISH LINE AND CMS
REIMBURSEMENT.
WE'VE SEEN SOME OF THAT KIND OF
RALLYING AROUND IN IN VITRO
DIAGNOSTICS UNDER THIS
PARTICULAR TIME WHERE THEY WERE
REVOLUTIONARY TECHNOLOGY, SO TO
SPEAK, THAT HAD NOT BEEN FULLY
DEPLOYED AND WE HAVE NOW MOVED
THEM INTO THE HOME AT A TOTALLY
DIFFERENT SCALE.
SO, THIS IS GOING TO REALLY
DEPEND ON YOU, LEADERS AND
EXPERTS IN THE FIELD, TO HELP
IDENTIFY KEY USE CASES WHERE
IT'S A COMBINATION OF DOABILITY
IMPORTANCE AND NOT TOO HARD.
SO THAT'S WHAT WE'RE LOOKING
FOR.
>> ANOTHER QUICK POINT TO TIE TO
THE PREVIOUS PRESENTATION ABOUT
DATA AND DATABASES.
I THINK IT'S GOING TO BE
CRITICAL TO HAVE KIND OF A
BIOMATERIALS DATABASE.
THERE'S BEEN EFFORTS IN THE PAST
AND NIST HAS DONE REALLY
WONDERFUL THINGS BUT IT'S REALLY
A CHALLENGE.
JUST EVEN TO GET STANDARDS.
IT'S WONDERFUL THE MODEL YOU
HAVE COORDINATING CENTERS AND
NETWORKS TOGETHER SO I THINK
THAT'S A GOOD MODEL BUT WE
DEFINITELY HAVE TO THINK HOW TO
HANDLE THE DATA AND MAKE THAT
KIND OF STANDARDIZED SO YOU CAN
COMPARE.
>> THANK YOU FOR THAT COMMENT.
I DEFINITELY AGREE.
BIOMATERIAL STANDARDS IS
SOMETHING THAT BEING BUILT IN AN
INDUSTRY, ACADEMIA ISN'T
NECESSARILY PICKING THEM UP AND
WE TRIED TO BUILD THAT INTO
THIS, BEING ABLE TO GET THE DATA
OUT THAT WE CAN LEVERAGE AS WELL
.
>> OKAY.
HEARING NO MORE COMMENTS, THANK
YOU FOR YOUR SUPPORT OF
ASSESSMENT AS WELL AS EXCELLENT
THINGS TO FACTOR IN.
WE NEED TO MAKE SURE EVERYONE
WHO IS INVOLVED IS INVOLVED,
EVERYONE WHO NEEDS TO BE
INVOLVED IS INVOLVED.
SO THANK YOU VERY MUCH.
THAT'S OUR LAST PRESENTATION.
SO, BRUCE, BEFORE WE ADJOURN IF
YOU WANTED TO MAKE ANY FINAL
REMARKS AT THE END OF OPEN
SESSION?
>> SURE.
THANKS, DAVE.
I WANT TO THANK COUNCIL AGAIN
FOR YOUR ENGAGEMENT,
PARTICIPATION, INCREDIBLE
FEEDBACK, DYNAMIC CONVERSATION,
WE'RE LOOKING FORWARD TO MAY
WHEN WE HAVE AN IN-PERSON
MEETING, WE HOPE, HOPEFULLY
MOVING INTO THAT DOMAIN IN
REGULAR INTERACTIONS.
AND I THINK THE ENTIRE NIBIB
STAFF, WE'RE LIKE A START-UP
WHEN YOU COMPARE US TO THE MORE
CORPORATE INSTITUTES LIKE NIAID
AND NCI AND OPERATE LIKE THAT,
EVERYBODY IS ENGAGED,
CONSIDERING TO THIS COUNCIL
MEETINGS, LIKE A SMALL BOARD OF
DIRECTORS MEETING FOR A START-UP
COMPANY.
SO WE APPRECIATE EVERYBODY'S
WORK ON BEHALF OF THAT AND ALL
OF YOUR ATTENTION AND FEEDBACK.
EVERYONE IS LISTENING TO WHAT
YOU SAY.
AND WE'LL BE INTEGRATING THAT
INTO WHAT HOPEFULLY WILL BE
ANOTHER EXCITING PRESENTATION IN
THE NEXT COUNCIL.
THANK YOU ALL.
>> THANK YOU, BRUCE, FROM ME AND
JILL AND OTHER COLLEAGUES, THANK
YOU VERY MUCH.
BEFORE I ADJOURN OPEN SESSION,
I'D LIKE TO REMIND COUNCIL
MEMBERS AND NIBIB STAFF CLOSED
SESSION WILL BE IN A SEPARATE
ZOOM LINK.
LET'S TAKE A FIVE-MINUTE BREAK.
YOU SAW FROM THE ELECTRONIC
COUNCIL BOOK, IT'S A BRIEF
CLOSED SESSION, WE CAN READILY
BE DONE ON TIME.
NO WORRIES.
SO WE'LL START AT LIKE, SAY,
3:05, IF EVERYONE IS OKAY WITH
THAT.
I'D LIKE TO THANK OUR VISITORS
FOR ATTENDING ON VIDEOCAST.
WE HOPE YOU CAN ATTEND THE NEXT
COUNCIL MEETING, IN VIDEO.
HOPEFULLY IN PERSON IN THE MAY
OF 2023 MEETING.
SO THIS OPEN SESSION OF THE
60th MEETING OF THE NIBIB
NATIONAL ADVISORY COUNCIL IS
HEREBY ADJOURNED.