I'D LIKE TO WELCOME YOU TO THE
61st MEETING OF THE NATIONAL
ADVISORY COUNCIL FOR BIO MEDICAL
IMAGING AND BIO ENGINEERING.
I'M DAVID GEORGE, NIBIB
EXECUTIVE SECRETARY OF THIS
COMMITTEE.
THIS COUNCIL MEETING IS OPEN TO
THE PUBLIC EXCEPT FOR THE REVIEW
OF PENDING GRANT APPLICATIONS
WHICH WE WILL DO LATER IN THE
AFTERNOON.
THE OPEN SESSION OF THE SESSION
IS BEING LIVE BROADCAST ON THE
NIH VIDEOCAST NETWORK AND
RECORDED FOR NIH ARCHIVE.
THE COMMITTEE AND PRESENTERS ARE
PRESENTING VIA VIDEOCAST AND WE
WELCOME OUR SPECIAL GUESTS AND
THOSE WATCHING ON VIDEOCAST AS
WELL.
MEMBERS OF THE PUBLIC WHO WISH
TO EXPRESS VIEWS REGARDING ANY
ITEMS DISCUSSED DURING THE
MEETING MAY DO SO IN WRITING
WITHIN THE NEXT 10 DAYS BY
E-MAILING ME AT INFO AT
NIBIB.NIH.gov.
THAT'S N-I-F SORRY,
I-N-F-O@N-I-B-I-B.N-I-H DOT
G-O-V.
BUT NIBIB IN THE SUBJECT LINE.
IN TERMS OF BEST PRACTICES WE
ASK YOU PLEASE MUTE YOURSELF
WHEN NOT SPEAKING OR FOR
COLLEAGUES WHO ARE PRESENTING,
REMINDER TO PRESENT FROM A FILE
LOCATED ON YOUR COMPUTER'S HARD
DRIVE RATHER THAN NETWORK DRIVE
AND BE LOGGED OFF VPN WHILE
PRESENTING AND SHUT DOWN FUNDING
SOFTWARE.
THE CHAT BOX IN THE ZOOM IS
ENABLED ONLY TO CHAT WITH OUR
HOST, MR. RYAN DAVA AND I.T.
COLLEAGUES.
FOR TECHNICAL PROBLEMS REACH
RYAN VIA HIS E-MAIL WE'LL PUT IN
THE CHAT BOX.
>>IN TERMS OF ANNOUNCEMENTS WE
HAVE A QUORUM FOR THE RECORD AND
WOULD LIKE TO THANK THE
COMMITMENT MANAGEMENT SPECIALIST
FOR ALL THEIR WORK IN ARRANGING
THE MEETING.
ALSO TO OUR COLLEAGUES RYAN DAV
AND COLLEAGUES IN I.T. AND NIBIB
FOR WORKING ON THE CONFERENCE EN
MEETING AND THIS IS BACKED BY
THE GOVERNMENT SUNSHINE ACT AND
CONSEQUENTLY IT MEANS THE
MEETING WAS ANNOUNCED SO THE
PUBLIC IN THE FEDERAL REGISTER
AND CONSISTS OF AN OPEN PORTION
THAT WE'RE IN NOW ACCESSIBLE TO
THE PUBLIC AND A PORTION THAT
WILL BE CLOSED LATER ON THIS
AFTERNOON FOR DISCUSSION OF
INDIVIDUAL APPLICATIONS.
WE ANTICIPATE ADJOURNING ABOUT
2:45 P.M. OF THE EXECUTIVE
SESSION.
THE COUNCIL DATES ARE LISTED AT
THE BOTTOM OF THE AGENDA.
COUNCIL MEMBERS AVAILABLE IN THE
COMPUTER SYSTEM YOU CAN ACCESS
ONLINE.
WE ASK YOU COULD REVIEW THE
DATES WHEN YOU GET THE CHANCE
AND LET US KNOW BECAUSE WE
SCHEDULE COUNCIL ON MEETINGS
THAT EVERY LAP THE CONFERENCE
AND MAY TAKE SOME OF YOU AWAY
FROM ATTENDING COUNCIL.
YOU'LL SEE OUR NEXT MEETING IS
SCHEDULED FOR MAY 16 AND OUR
CURRENT PLANS ARE TO HOLD IN
PERSON.
WE'RE DOING WORK AND RESEARCH TO
MAKE THOSE ARRANGEMENTS AND
LOOKING FORWARD TO SEEING
EVERYONE IN PERSON.
I'D LIKE TO MOVE TO
CONSIDERATION OF THE MINUTES IN
THE COUNCIL OPERATING PROCEDURES
AND PLEASE UNMUTE YOURSELF TO
CAST A VOICE VOTE.
REGARDING THE MINUTES, THE
MINUTES WERE MADE AVAILABLE TO
YOU TWO WEEKS AGO IN THE ECB.
ARE THERE COMMENTS OR
MODIFICATIONS YOU'D LIKE TO MAKE
TO THE MINUTES.
HEARING NONE, I'LL ENTERTAIN A
MOTION TO APPROVE.
>>I MOVE.
>>MOVED IS THERE A SECOND?
THERE'S A SECOND.
THANK YOU, ALL IN AGREEMENT SAY
AYE.
ALL OPPOSED, NAY.
THANK YOU.
THE NEXT IS OUR COUNCIL
OPERATING PROCEDURES.
EVERY JANUARY WE REAFFIRM OUR
COUNCIL OPERATING PROCEDURES.
THE DRAFT OPERATING PROCEDURES
WERE MADE AVAILABLE TWO WEEKS
AGO IN THE ECB.
AND THIS COUNCIL WE PROPOSED NO
CHANGES TO THE OPERATING
PROCEDURES.
ARE THERE COMMENTS OR
MODIFICATIONS YOU'D LIKE TO MAKE
TO THE OPERATING PROCEDURES?
HEARING NONE THEN I'LL ENTERTAIN
A MOTION TO APPROVE THEM.
SO MOVED AND SECONDED.
AND ALL THOSE IN AGREEMENT SAY
AYE.
THOSE OPPOSED NAY.
OKAY.
THANK YOU THAT PASSES.
WITH THOSE INTRODUCTIONS THEN
THANK YOU VERY MUCH WE'LL MOVE
INTO THE MAIN PROGRAM NOW.
SOME MAY HAVE HEARD AS WE WERE
GETTING READY WE'RE AWAITING
DR. PETTIGREW WHO WILL BE HERE
LATER SO IT'S POSSIBLE WE MAY
CHANGE THE ORDER OF THE CONCEPT
CLEARANCES LATER IN THE PROGRAMS
PENDING HIS ARRIVAL AS A MEMBER
OF OUR DEI WORKING GROUP.
BUT AT THIS TIME MOVE ON TO THE
PROCEEDINGS OF THE NIBIB
DIRECTOR'S REPORT AND ACCESSIBLE
COVID-19 HOME TEST BY DR. BRUCE
TROMBERG.
>>THIS IS THE MOMENT I LIKE TO
TEST BANDWIDTH OF THE SYSTEM.
HOPEFULLY EVERYBODY CAN TURN
YOUR MICROPHONES ON AND PRETEND
WE'RE IN THE ROOM IN MAY.
SAY HELLO, HAPPY NEW YEAR.
GOOD TO SEE ALL OF YOU.
IT'S BEEN A WHILE SO THANK YOU
FOR COMING.
WELCOME.
THIS IS A GOOD TIME TO HAVE A
VIRTUAL MEETING.
IT'S VERY COLD AND WET HERE SO
YOU DON'T REALLY WANT TO BE
COMING AND TRAVELLING TO THE
EAST COAST BUT HOPEFULLY MAY
WILL BE REALLY TERRIFIC AND THAT
WILL TURN OUT TO BE OUR REGULAR
IN-PERSON MEETING AS THE WHOLE
COUNTRY SORT OF SHIFTS TO THOSE
AND CONTINUES TO DEBATE ON THE
MERITS OF VIRTUAL VERSUS IN
PERSON.
MAYBE COUNCIL HAS SOME OPINIONS
ON THIS.
HOPEFULLY EVERYONE IS INTERESTED
AND EXCITED ABOUT THE MAY
MEETING.
YEAH?
OKAY.
WE SEE A LOT OF NODS.
GREAT.
I WILL NOW GO AHEAD AND SHARE MY
SCREEN AND GET INTO THE
PRESENTATIONS.
I THINK WE HAVE A PRETTY
INTERESTING COUNCIL MEETING FOR
YOU WITH LOTS OF HOPEFULLY LOTS
OF DISCUSSION.
AND I'D FIRST LIKE TO START AS I
USUALLY START BY THANKING OUR
ENTIRE STAFF.
NIBIB IS AN AMAZING INSTITUTE
AND EVERYONE PITCHES IN FROM TOP
TO BOTTOM.
WHAT I'LL TALK ABOUT TODAY IS A
CONSEQUENCE OF ENORMOUS EFFORT
FROM EVERYONE ALL ACROSS THE
INSTITUTE.
AND AS DAVID MENTIONS SPECIAL
THANKS TO PAM AND ALICIA FOR
THEIR WORK ON COUNCIL
ORGANIZATION.
THEY'RE BUSILY AT THE LIVE
COUNCIL MEETING.
IT'S AN EXTRA WORKLOAD.
WE'VE KIND OF FORGOTTEN HOW MUCH
WORK IT IS AND OUR SENIOR
LEADERSHIP OUR ACTING EXECUTIVE
OFFICER INCLUDED OUR EXECUTIVE
OFFICER IS CURRENTLY DOING A
DETAIL AT THE NATIONAL CANCER
INSTITUTE SO WE'RE REALLY GLAD
TO HAVE ANNE WHO WE'VE WORKED
WITH THE LAST FEW YEARS IN RAD X
COME FROM NHLBI TO SERVE IN THAT
POSITION.
I'D ALSO LIKE TO TAKE A MOMENT
TO THANK OR SLIDE TEAM.
THEY DO AN INCREDIBLE JOB
GETTING THE MATERIALS TOGETHER
AND REACHING OUT TO EVERYBODY
ACROSS NIBIB AND INTERACTING
WITH THEM AND PAYING CLOSE
ATTENTION TO ALL THE DETAILS WE
NEED TO HAVE.
THANK YOU VERY MUCH TO THE SLIDE
TEAMS.
WHILE WE'RE THANKING, I WANT TO
POINT OUT A REALLY AMAZING
ACCOMPLISHMENT THANKING THE
OFFICE OF SCIENCE POLICY AND
COMMUNICATIONS.
THIS IS AN AMAZING OFFICE.
YOU MAY OR MAY NOT HAVE
INTERACTED WITH THEM AS LED BY
CHRIS COOPER WITH SHIRLEY
JOHNSON AND SHARON OLSON AND
PATTY WILEY AND JESSICA MEADE.
THEY'RE CRANKING OUT WAYS TO
SHOW THE WORLD WHAT NIBIB DOES
AND WE HAVE MORE THAN 5 MILLION
VIEWS ON OUR YOUTUBE CHANNEL.
THAT'S ACTUALLY THE FIFTH
HIGHEST RANKING.
YOU MAY NOT BE SURPRISED NLM IS
THE RANKING CHANNEL.
I THINK OVER 13 MILLION VIEWS
BUT THE NEXT FOUR ARE VERY CLOSE
AND WE'RE UP THERE WITH THE BIG
INSTITUTES.
WE JOKE THAT IF YOU LOOKED AT
THE VIEWS PER DOLLAR PER
INSTITUTE WE WOULD BE -- I
GUESS, THE MOST IMPACTFUL,
HEAVIEST HITTING ONE ON A PER
DOLLAR APPROPRIATED BASIS.
JUST KIND OF TO POINT OUT AND
SOME OF YOU MAY HAVE SEEN THESE,
WE HAVE TOP FIVE VIDEOS ABOUT
HOW VARIOUS IMAGING TECHNOLOGIES
WORK THAT ARE THE MOST VIEWS AND
ALL THESE VIEWS CONTINUE TO GROW
MORE THAN 3 MILLION ADDITIONAL
VIEWERS JUST IN THE PAST FOUR
YEARS.
THEY ALSO PUTTING TOGETHER THIS
WONDERFUL SUMMARY THE NIBIB YEAR
IN REVIEW THAT HAS SCIENCE VIEWS
AND PROGRAM VIEWS SO IF YOU
HAVEN'T SEEN THAT PLEASE CHECK
IT OUT.
AND IF YOU HAVE IDEAS, THINGS TO
COMMUNICATE, IMPORTANT
DISCOVERIES, THINGS YOU'D READ
ABOUT YOU THINK SHOULD BE ON OUR
WEBSITE, WELL, IT'S OBVIOUSLY
NOT THE MOST WIDELY -- IT'S NOT
THE NEW YORK TIMES BUT I THINK
WE HAVE A GOOD FOLLOWING AND
IT'S GROWING.
PLEASE LET US KNOW WHAT YOUR
IDEAS ARE.
SO WE HAVE A COUNCIL MEMBER WHO
IS LEAVING AND I WANTED TO TAKE
A MOMENT TO THANK THEM.
THEY'RE LEAVING A LITTLE EARLY.
SOME MAY KNOW REASONS WHY.
THAT'S BECAUSE MANU IS JOINING
COUNCIL AND THANK YOU FOR
JOINING NIBIB AS THE NEW
DIRECTOR, THE FIRST FOUNDING
DIRECTOR OF THE BIO MEDICAL AND
TECHNOLOGY ACCELERATION CENTER.
MANU TAKES THIS POSITION AND TO
REFRESH YOU ON WHAT THE BETA
CENTER IS IS A NEW NIH WIDE
CENTER FOR INTERDISCIPLINELY
RESEARCH AND CLINICAL
TRANSLATION.
IT WILL ACCELERATE, WE BELIEVE,
THE VALIDATION AND DISSEMINATION
OF HIGH IMPACT MEDICAL
TECHNOLOGIES.
I THINK IMPORTANTLY FOR COUNCIL
AND YOU'LL HEAR MORE LATER WHEN
ALBERT AVILA MAKES HIS
PRESENTATION OF A CONCEPT
CLEARANCE, THE CONDUIT AND THE
MECHANISM, A CATALYST FOR
PARTNERING WITH THE VME AND
TECHNOLOGY COMMUNITY AND HELP
LEAD EXPANSION OF DIVERSITY,
EQUITY, INCLUSION AND
ACCESSIBILITY WITHIN THE NIH
INTRAMURAL RESEARCH PROGRAM.
WE'LL TALK MORE ABOUT THAT
TODAY.
NICOLE MORGAN WHO LEADS OUR
TRANS NIH RESOURCE ON BIO
ENGINEERING AND PHYSICAL SCIENCE
AND IS ALSO OUR TRAINING
DIRECTOR AGREED AND ACCEPT THE
POSITION OF DEPUTY DIRECTOR.
THIS IS EXTREMELY IMPORTANT FOR
US.
SHE IS INCREDIBLY KNOWLEDGEABLE
AND SKILLS ACROSS THE NIH BOTH
IN THE INTRAMURAL PROGRAMS AND
IN UNDERSTANDING HOW TO MAKE
STUFF WORK.
WE'RE LOOKING FORWARD TO MANU
ARRIVING AND NICOLE TO LAUNCH
THE CENTER.
AT THIS TIME I'M GOING TO STOP
SHARING AND INVITE MANU TO POP
ON.
THERE HE IS.
YOU'RE HERE.
>>I'M HERE, THANK YOU.
>>THE FLOOR IS YOURS.
>>THANK YOU, BRUCE.
THANK YOU TO BRUCE AND THE
SEARCH COMMITTEE AND OF COURSE
WHO PLANTED THE FIRST BUG IN MY
YEAR ONE SURPRISING SATURDAY
AFTERNOON AND ROB PETTIGREW WHO
KNOWS THE PLACE WILL.
MANY KNOW I HAVE A DEEP LOVE FOR
GEORGIA TECH AND EMORY IN
ATLANTA I WAS AN UNDERGRAD
RESEARCHER MY SENIOR YEAR AT
MOREHOUSE COLLEGE AND GOT MY
Ph.D. AND AFTER A POSTDOC AT
M.I.T. STARTED MY INDEPENDENT
RESEARCH YEAR JANUARY 1, 2009
HERE IN ATLANTA A FEW WEEKS
BEFORE BARACK OBAMA WAS
INAUGURATED.
I WORKED MY WAY UP TO FULL
PROFESSOR AND WHEN I WAS
THANKFUL SUSAN MARGUILES WAS MY
MENTOR.
I HEARD ABOUT SO MANY BEING THE
THREE BLACK WOMEN FULL
PROFESSORS IN CHEMICAL
ENGINEERING.
THE TIMES ARE ACHANGING.
MORE HAVE COME BEFORE ME AND
BEHIND ME.
VINCENT JOINED THE COUNCIL AND A
GOT TO SEE THE WORK THAT WAS
HAPPENING AND THE HONEST NATURE
AND INTENTION BEHIND ALL THE
EFFORTS AT NIBIB WITH THE
EXCEPTIONAL STAFF AND TEAM.
SEEING THAT WAS ENLIGHTENING AND
AFTER SPEAKING WITH SO MANY OF
MY VALUED MENTORS AND HEROES, I
MADE THE DECISION TO JOIN THIS
WONDERFUL OPPORTUNITY AS
DIRECTOR OF THE BETA CENTER AND
THE ASSOCIATE DIRECTOR OF DDIA
FOR NIBIB AND TO OFFER MY
RESEARCH LAB TO THE INTRAMURAL
PROGRAM.
AND MY LAB WAS GOING TO CHANGE
NAMES.
WE'RE GROWING UP TO BEING THE
MATRICES LAP LAB WHICH STANDS
FOR MECHANICS AND TISSUE
REMODELLING AND COMPUTATIONAL
AND EXPERIMENTAL SYSTEMS.
I'M ALREADY GETTING MY FEDERAL
ACRONYMS DOWN SO I'M IN THE MIX.
IT'S LIKE I'M RETURNING TO THE
FEDERAL RESEARCH LABS.
I WORKED AT SEVERAL FEDERAL LABS
EVERY SUMMER.
THREE DIFFERENT SITES ACROSS THE
COUNTRY AND THEN A NASA
FELLOWSHIP FOR GRAD SCHOOL AND
WENT BACK TO JOHNSON SPACE
CENTER IN HOUSTON AND AFTER MY
Ph.D. I CAME TO NIH WORKING ON A
BRIEF INTERNSHIP.
NOW I'M COMING BACK IN BUILDING
35A.
AND I SAW MULTIPLE SIGNS AND WE
ESTABLISHED THE GREAT PROGRAMS
AND WORKED TO BUILD NEXT
GENERATION OF DIVERSE AND
TALENTED SCIENTISTS AND
ENGINEERING WHICH IS WHY IT'S
BEEN A TOUGH DECISION TO LEAVE
THE COMFORT OF MY COMMUNITY IN
ATLANTA.
AS A TEACH DURING MY DIVERSITY
AND INCLUSION TRAINING THERE'S
NO GROWTH IN THE COMFORT ZONE
AND NO COMFORT IN THE GROWTH
ZONE SO TIME TO GROW AND TIME TO
GET UNCOMFORTABLE.
AND THERE'S A TEAM THAT'S BEEN
SO HELPFUL AND THERE'S
INSPIRATION TO JOIN THIS TEAM.
>>I'M GOING TO PARAPHRASE A
FAMOUS LINE, MANU THIS IS YOUR
DESTINY JUST FROM WHAT YOU WENT
THROUGH IT'S KIND OF CLEAR, WE
ALL FELT IT BUT THIS SEEMS TO BE
IT.
MANU, THERE'S ALMOST NO OTHER
WAY TO SAY THIS HE PERSONIFIES
THE IDEA OF PRINCIPLES AND
CONCEPT BEHIND THE BETA CENTER.
THERE'S A PRESS RELEASE I
BELIEVE COMING OUT TODAY AND MAY
BE OUT RIGHT NOW AND WE'RE
EXCITED TO HAVE YOU.
WE HAVE JENNICA PATTERSON IS A
NEUROSCIENTIST BY TRAINING AND
COMING FROM NIAAA THE ALCOHOL
INSTITUTE AND HAD FOUR YEARS OF
EXPERIENCE AS A DARPA SCIENCE
ADVISER AND WORKED SHE WAS ON
DETAIL WITH US FROM NIAAA AND
WITH RADX FOR THE MOST IMPACTFUL
FUL IN VITRO TECHNOLOGIES AN
INVOLVED IN THE INNOVATION TUL.
ALBERT AVILA AND HE WAS
PREVIOUSLY -- HEAD OF THE OFFICE
OF DIVERSITY AND HEALTH
DISPARITIES IN NIDA.
ANOTHER NIH INSTITUTE
AND HE HAD ENORMOUS EXPERIENCE
AND INTERACTIONS AND RECOGNIZED
ACROSS THE NIH FOR HIS WORK IN
TRAINING AND DIVERSITY STARTING
NEW INITIATIVES.
HE'S RECEIVED SEVERAL AWARDS IN
THIS AND WE WERE SO LUCKY TO
HAVE HIM COME TO NIBIB BECAUSE
HE WAS ALREADY IN SUCH A MAJOR
LEADERSHIP ROLE ACROSS NIH DOING
THIS AND I THINK HE WAS
PARTICULARLY EXCITED AND PERHAPS
INSPIRED BY THE FACT THAT -- AND
THIS IS A PERSONAL NOTE ON
ALBERT, HIS DAUGHTER IS A
FRESHMAN BIOMEDICAL ENGINEERING
STUDENT AT CASE AND SHE IS I
THINK AN INSPIRATION IN PART FOR
HIM TO COME TO THE NIBIB AND
YOU'LL HEAR LATER FROM ALBERT ON
THE CONCEPT CLEARANCE FOR OUR
HBCU INITIATIVE.
PETER LYSTER MANAGED AN EFFORT
IN SYSTEMS BIOLOGY AND HE
RETIRED FROM NIH BUT WE'RE LUCKY
TO HAVE HIM COME BACK FOR THE
MATH TECHNOLOGIES DIVISION.
AND THERE'S A CHIEF GRANTS
MANAGEMENT OFFICER.
GOOD TO HAVE HIM COME TO NIBIB.
HE HAS 17 YEARS OF GRANTS
MANAGEMENT ACROSS THE NIH.
HIS PREVIOUS ROLE AT THE
NATIONAL CANCER INSTITUTE FOR 10
YEARS AND SEVEN YEARS AT NINDS
AND WE KNOW THE SCALE OF NCI IN
A SMALL GROUP SO-CALLED SMALL
GROUP WAS LARGER THAN THE ENTIRE
PORTFOLIO AT NIBIB.
SO IT'S GRANTS MANAGEMENT AND HE
CAN DO COMPUTATION AS WELL.
WE'RE GLAD TO HAVE MUTEMA JOIN
US.
WE HAVE MOHD ANWAR A DATA
SCHOLAR AND PROFESSOR OF
COMPUTER SCIENCE AT NORTH
CAROLINA A&T AND EXPERT IN DATA
SCIENCE AND QUANTUM COMPUTING.
SPANS THE ENTIRE UNIVERSE OF
DATA AND INFORMATION.
HE IS ONE OF THE FEW PEOPLE I
KNOW ACTUALLY, MAYBE THE ONLY
ONE IN OUR EXTRAMURAL PROGRAM
THAT HAS ACCESS TO THE SUPER
COMPUTER CLUSTER AND USING IT ON
A REGULAR BASIS.
AS YOU CAN SEE, MOHD IS WORKING
IN THE HEALTH INFORMATICS
DIVISION AND PRINCIPALLY FOCUSED
ON THE DIGITAL HEALTH PLATFORMS
AND PERSONAL INPUT DEVICES THAT
GO INTO THOSE DIGITAL HEALTH
PLATFORMS.
BUT HE BRINGS BROAD EXPERTISE IN
ALL AREAS OF DATA SCIENCE.
FINALLY, BRAD BOWER IS ANOTHER
DATA SCHOLAR WHO JOINED US IN
THE DIVISION OF DATA SCIENCE AND
SOME KNOW BRAD'S BACKGROUND.
HE DID HIS Ph.D. IN PROGRAMS
TOMOGRAPHY AT DUKE AND WORKED AT
CASE AS AN UNDERGRADUATE AND HAD
A DIVERSE SET OF EXPERIENCES IN
ENTREPRENEURSHIP AND DATA
SCIENCE.
HE BRINGS ENORMOUS EXPERTISE TO
THE POSITION OF DATA SCHOLAR AND
WORKING IN A PROGRAM MANY ARE
FAMILIAR WITH AND WELCOME TO THE
SIX INDIVIDUALS WHO MAKE AN
ENORMOUS CONTRIBUTION AND WE'RE
HAPPY TO HAVE YOU AT NIBIB.
I'D LIKE TO THANK TWO PEOPLE
LEAVING.
THEY ARE BOTH AND THERE'S
SPECIAL APPOINTMENTS WE HAD.
MANY OF YOU HAVE INTERACTED WITH
RUI AT U.C. SAN DIEGO.
AS A DATA SCHOLAR THE PAST FEW
YEARS HE'S BEEN INVOLVED IN
ESTABLISHING AND EXPANDING THE
PROGRAM.
HIS CONTRIBUTIONS HAVE BEEN
ABSOLUTELY ESSENTIAL.
AND KRISHNA JULURU IS ALSO
LEAVING.
KRISHNA WILL BE FOR ONE MORE DAY
A PRESIDENTIAL INNOVATION
FELLOW.
A SPECIAL APPOINTMENT THAT WE
HAD ALSO FOR THE PAST TWO YEARS.
HE WORKED IN THE OFFICE OF THE
DIRECTOR AND HAS BEEN CRITICAL
FOR ALL OF OUR DIGITAL HEALTH
PLATFORMS AND TECHNOLOGY GROWTH
IN THE RAD X PROGRAM ITSELF AND
YOU'LL HEAR WHEN THEY GIVE A
SUMMARY PRESENTATION WITH
PROGRESS IN THE AREA LATER ON
TODAY.
AND WE HAVE DIRECTOR OPENING IN
THE TWO DIVISIONS.
TO SUMMARIZE ALL OF THAT,
MEDICAL IMAGING TECHNOLOGIES IS
ONE OF THE PROGRAM DIRECTOR
POSITIONS AND POINT OF CARE AND
TAL HEALTH TECHNOLOGIES IS THE
OTHER ONE.
THESE ARE POSTED ON THE USA JOBS
WEBSITE.
AND WE'LL HAVE POSTINGS ON OUR
WEBSITE.
THE DUE DATES ARE IB A COUPLE
DAYS.
IT'S KIND OF A BROAD GROUP THAT
WE'RE HOPING TO BE ABLE TO
ATTRACT.
MAYBE PEOPLE WHO ARE IN
ACADEMICS OR INDUSTRY WHO ARE
LOOKING FOR OTHER CHALLENGES
PERHAPS IN GOVERNMENT, WE'RE
ENCOURAGING ALL OF YOU ON
COUNCIL TO THINK OF COLLEAGUES
WHO MAY BE INTERESTED IN
APPLYING.
AGAIN, THESE TWO POSITIONS
EXTREMELY IMPORTANT TO OUR
OPERATION OVER ALL.
ARE OPEN AND AVAILABLE AND SEND
US A NOTE IF YOU HAVE QUESTIONS.
YOU CAN SEE THE CONTACTS ARE
DIVISION DIRECTORS AND CHRIS AND
BRUCE FOR EACH OF THESE.
THIS IS A LITTLE BIT BUDGET
UPDATE WHICH EVERYONE WE LIKE TO
DO FOR EACH COUNCIL MEETING.
THE BIG NEWS IS THAT THERE WAS
AN OMNIBUS AND WE HAVE A BUDGET
FOR FY23.
AND THAT BUDGET IS INCREASED
OVER FY22 ABOUT A 5.6% INCREASE.
CONGRESS HAS BEEN QUITE GENEROUS
IN THE EXPANSION OF THE BUDGET.
THE TOTAL IS NOW $47.5 BILLION
FOR ALL OF NIH.
NIBIB'S BUDGET IS A LITTLE LESS
THAN 1%, $441 MILLION.
IT'S A 3.8% INCREASE VERSUS THE
PREVIOUS FISCAL YEAR.
AND TO GIVE YOU A SENSE THAT'S
ABOUT AVERAGE FOR A TYPICAL
INSTITUTE IN TERMS OF THEIR
INCREASE.
NOT ALL INSTITUTES SAW A 5.6%
INCREASE.
THE ONE THAT WAS REFLECTED IN
THE OVER ALL NIH BUDGET AND
THAT'S BECAUSE THERE'S A VARIETY
OF ADDITIONAL PROGRAMS THAT
RECEIVE VERY SPECIFIC FUNDING
LINES.
YOU MAY BE FAMILIAR WITH SOME OF
THESE AND I'M SHOWING THEM
BECAUSE NIBIB PARTICIPATES IN
PROGRAMS WITH ALL THESE FUNDING
LINES.
THE ADDITIONAL SUPPLEMENTS FOR
ALZHEIMER'S AND THERE'S A
SPECIFIC LINE ITEM FOR ALL OF
AND YOU ANTIMICROBIAL
RESISTANCE, DATA SCIENCE,
INITIATIVE AND THE HEAL
INITIATIVE, IMPROVE, THE OFFICE
OF ENGAGEMENT FOR WOMEN'S HEALTH
AND WE PARTNER WITH ALL OF THEM.
THAT'S ONE EXTREMELY IMPORTANT
POINT.
EVENTUALLY THROUGH PARTNERSHIPS
WE'RE ABLE TO INCREASE
EXPENDITURES AND GIVE NEW
OPPORTUNITIES FOR OUR COMMUNITY.
THE SECOND POINT ABOUT SHOWING
ALL OF THIS IS WE ASPIRE TO BE
ONE OF THOSE DOTS ONE DAY, ONE
OF THOSE BULLET POINTS WHERE
PERHAPS ONE OF OUR PROGRAMS MAY
BE SINGLED OUT.
WE WERE ONE OF THOSE PROGRAMS
SINGLED OUT IN A LARGE WAY
THROUGH SUPPLEMENTAL FUNDING.
BUT OF COURSE OUR AS HIR
PASSIONAL GOAL IS TO SEE THAT IN
OCCURRING ADDITIONAL FUNDING
PROGRAM.
THIS IS AN EXCELLENT TOOL TO
SEARCH THROUGH ALL OF OUR
PROGRAMS IN ALL THESE DIFFERENT
AREAS INCLUDING PARTNERSHIPS
WITH OTHER INSTITUTES AND
CENTERS IN A VARIETY OF
MECHANISMS.
I'LL JUMP RIGHT INTO THIS THE
TRAILBLAZER R21 HAS BEEN
RE-ISSUED.
THERE'S BEEN TWO ADDITIONAL
INSTITUTES NEI AND NIA THAT
SIGNED ON TO THE R21 WHICH WE'RE
EXCITED ABOUT.
EVERYONE KNOWS RANDY KING OUR
LEAD FOR THIS PROGRAM PLEASED
MAKE SURE THEY CONNECT WITH
RANDY TO TALK AND STRATEGIZE HOW
TO VIEW APPLICATIONS.
IT'S A DIFFERENT APPLICATION
FROM TYPICAL R21s OR ANY TYPICAL
NIH GRANT.
IT FOCUSES ON NEW AND EARLY
STAGE INVESTIGATORS.
AND THE APPLICATION DUE DATES WE
ADDED A DATE TO THE FOA AND
THERE'S TWO DUE DATES FOR THAT
NOW MAY 31 IS ADDED AND SO
THAT'S A NEW POSTING.
WHAT WE DECIDED TO DO WITH THE
HEALTH DISPARITIES OR THE
SCIENTIFIC WORKFORCE DIVERSITY
RO1 IS AFTER THE FEBRUARY DUE
DATE, WE'RE ACTUALLY WITHDRAWING
FROM THE ORIGINAL RFA.
AND WE'RE DOING THAT BECAUSE
THERE IS AN NIH WIDE FOA ON
SCIENTIFIC WORKFORCE DIVERSITY
THAT SEEMS TO FIT OUR NEEDS
BETTER AND LET ME TELL YOU A
LITTLE BIT ABOUT THAT.
SO THAT'S THIS TAR22-181
RESEARCH OPPORTUNITIES FOR NEW
AND AT-RISK INVESTIGATORS TO
PROMOTE WORKFORCE DIVERSITY.
THERE'S EIGHT OTHER NIH I.C.s
THAT PARTICIPATE AND THE
ADVANTAGE IS ALIGNS NIBIB WITH
THE GREATER EFFORT AND OPTIMIZE
MATCHING AND PARTNERSHIPS OF
APPLICATIONS WITH US AND WITH
OTHER I.C.s.
THERE'S THREE APPLICATION
RECEIPTS PER YEAR.
WE'RE EXCITED BY THAT AND I
THINK IT ADDRESSES THE ISSUE
THAT COUNCIL BROUGHT UP
REQUESTING WE INCREASE THE
APPLICATION RECEIPT DATES.
IT'S ELIGIBLE NOT JUST FOR NEW
INVESTIGATORS BUT ALSO FOR
AT-RISK INVESTIGATORS WHICH YOU
CAN LOOK AT THE RFA AND SEE WHAT
THE DEFINITION FOR THAT IS.
IT HAS AN EXTRA REQUIREMENT.
SO IT REQUIRES AN INSTITUTIONAL
ELIGIBILITY LETTER AND P.I.
STATEMENT ON HOW THEY'RE MEETING
THE FOA DIVERSITY GOALS AND IT
WILL BE REVIEWED IN CSR STUDY
SECTION THAT'S ALIGNED AND
ORIENTED BASED ON THE SCIENTIFIC
ASPECTS OF THE PROPOSAL.
SO YOU CAN SEE THE UPCOMING DUE
DATES.
THERE'S BEEN AN IMPORTANT ROLE
IN NAVIGATING THIS LEAVING OUR
PREVIOUS AND JOINING THIS NEW
ONE.
AND ALBERT AVILA IS A KEY
CONTACT PERSON FOR CONNECTING TO
GET MORE INFORMATION ABOUT THIS
AND TO HELP GUIDE INVESTIGATORS
AS THEY'RE APPLYING FOR THIS
PROGRAM.
SO WITH THE FUNDING
ANNOUNCEMENTS OF COURSE, I JUST
WANT TO REMIND EVERYONE THAT THE
NIH DATA MANAGEMENT SHARING
POLICY WHICH WAS DISCUSSED QUITE
EXTENSIVELY LAST TIME IN OUR
COUNCIL MEETING, YOU CAN GO BACK
TO THAT VIDEOCAST.
HERE'S THE LINK TO THAT
VIDEOCAST TO SEE WHAT THAT IS.
TODAY IS THE DAY IT GOES INTO
EFFECT.
SO THANKS TO CHI AND HIS TEAM
FOR ALL THE WORK -- QI AND HIS
TEAM FOR PUTTING THAT TOGETHER.
THERE'S A ONE-STOP NIH SHARING
WEBSITE AND IT HAS THE POLICY
GUIDANCE AND TOOLS IT'S ORIENTED
AROUND CULTURE AND HOW THE
COMMUNITY DOES RESEARCH AND YOU
CAN SEE THAT INFORMATION IN THE
VIDEOCAST OR CONTACT QI AND YOUR
PROGRAM DIRECT IF YOU HAVE
QUESTIONS.
I'D LIKE TO SUMMARIZE SOME OF
OUR MEETINGS AND WORKSHOPS PAST
EVENTS AS WELL AS UPCOMING
WORKSHOPS.
IN MID DECEMBER, DECEMBER 12,
THE 3P41 CENTERS CAME TOGETHER
TO DO A WORKSHOP ON MOLECULAR
IMAGING TECHNOLOGIES.
IF YOU'VE BEEN A PART OF THIS
AND IF YOU REMEMBER THE OLD DAYS
WHEN WE HAD P.I. MEETINGS ALL
THE P41 CENTERS WERE REPRESENTED
BY THE P.I.s AROUND THE COUNTRY
AND THERE WERE A VARIETY OF
DIFFERENT WAYS TO GET THE P.I.s
TO WORK AND TALK TO EACH OTHER.
THEY WERE NOT ALL THAT
EFFECTIVE.
SO WE THOUGHT A LOT AND HAD BEEN
THINKING A LOT ABOUT WAYS TO
OPTIMIZE HOW PEOPLE AT CENTERS
CAN COMMUNICATION AND BE
SYNERGISTIC AND THERE'S A SERIES
OF WEBINARS THAT CLUSTER P41
CENTERS AND INVESTIGATORS WHO
HAVE AREAS THAT ARE IN COMMON
AND CREATE WORKSHOPS AND
MECHANISMS FOR DISSEMINATING ALL
OF THAT INFORMATION THROUGH
RECORDINGS THAT WILL BE
AVAILABLE ON OUR WEBSITE AND
THIS IS THE FIRST ONE.
SO THIS WAS PROBABLY THE MOST
NATURAL ONE TO ORGANIZE AND WORK
WITH TATIANA AND ASHA ON THE
FORMATION.
WE HAVE THREE MAJOR CENTERS AND
THERE WERE OVER 140 ATTENDEES
FROM 40 DIFFERENT ORGANIZATIONS.
WE HOPE NEXT TO HAVE DATA
SCIENCE CENTERS COME TOGETHER
AND MRI CENTERS COME TOGETHER.
KEEP LOOKING ON THE P41 WEBSITE
AND I THINK IN PARTICULAR FOR
THOSE YOU WHO ARE THINKING ABOUT
DOING P41 APPLICATIONS AND
GETTING INVOLVED IN
COLLABORATIONS WITH P41 CENTERS,
THIS WOULD BE EXTREMELY
VALUABLE.
AGAIN, IN MID DECEMBER THE
SYNTHETIC BIOLOGY CONSORTIUM
MET.
OVER 180 ATTENDEES TO THIS.
SOME REALLY INCREDIBLE SPEAKERS
AND INNOVATIVE PROGRAMS AND TOOL
KITS, MODELLING CAPABILITIES AND
BOTTLENECKS.
A LOT OF DISCUSSION ON RESPONSES
TO THE PANDEMIC AND SCALING UP
TECHNIQUES.
THIS WAS LED AND ORGANIZED BY
JERMONT AND JULIA AND THERE'S
RECORDINGS ON THE WEBSITE.
IT'S A CONSORTIUM OF MULTIPLE
NIH INSTITUTE.
EXCITE ABOUT THE GROWTH IN THIS
PARTICULAR AREA AND I THINK THE
WORKSHOP CAPTURES THE ENTHUSIASM
AND POTENTIAL OF THE
TECHNOLOGIES TO BE A PLATFORM
ANOTHER AREA WE'VE BEEN HEARING
ABOUT AND THERE'S NASEM
WORKSHOPS ORGANIZED AND YOU CAN
REGISTER FOR THEM.
THE FIRST ONE BEING DIGITAL
TWINS AND BIO MEDICAL SCIENCES.
THE WORKSHOP SAT THE END OF
JANUARY.
-- IS AT THE END OF JANUARY.
HERE'S THE LINK.
GO TO THE NASEM HOME PAGE.
YOU CAN CONNECT TO IT.
IT'S AN AREA WE ARE REALLY
HOPING OUR COMMUNITY CAN TAKE
THE LEAD IN.
THERE WILL BE MANY OPPORTUNITIES
THAT EMERGE FROM IT.
ONE OF THEM THAT'S PERCOLATING
THROUGH DISCUSSIONS NOW BOTH
ACROSS NIH AND ACROSS OUR
COMMUNITY OF COURSE IS IN
CREATING IN SILICO MODELS THAT
COULD HELP REDUCE THE USE OF
ANIMALS IN RESEARCH.
THERE IS A BIG NIH GRANTS
CONFERENCE TWO DAYS COMING UP IN
FEBRUARY.
THIS IS KIND OF A HOW-TO.
THERE'S 25 SESSIONS WITH LIVE
Q&A.
I THINK COMMUNICATING THIS TO
ESPECIALLY YOUNG INVESTIGATORS
AND MID STAGE CAREER
INVESTIGATORS WHO WANT TO GET
INVOLVED IN THE NIH SYSTEM AND
REALLY UNDERSTAND HOW THE
PROCESS WORKS, THIS IS AN
ESSENTIAL.
SO PLEASE SPREAD THE WORD ON
THIS PARTICULAR WORKSHOP.
THIS IS NIH WIDE AND
REGISTRATION OF COURSE IS FREE
AND ALLOWS ACCESS TO THE ENTIRE
CONFERENCE.
A LIVE WORKSHOP IS COMING UP MID
MARCH AT THE JEFFERSON LAB IN
VIRGINIA.
A PARTNERSHIP BETWEEN NIH IN
PARTICULAR AND NIBIB AND NCI AND
THE DEPARTMENT OF ENERGY.
AND THERE'S A DOD LAB.
THIS WORKSHOP IS THE SECOND IN
BE AN ANNUAL SERIES.
TATIANA AND BEHROUZ ARE LEADING
THE EFFORT FROM CAMERAS AND
DETECTERS TO EXTERNAL IMAGING
AND ALSO FOR INTERNAL DIAGNOSTIC
IMAGING.
THERAPEUTICS APPROACHES FOR
MONITORING THERAPEUTICS AND
ARTIFICIAL INTELLIGENCE.
THIS IS A LIVE WORKSHOP AT THE
JEFFERSON LAB.
IT'S A WONDERFUL OPPORTUNITY TO
SEE HOW TECHNOLOGIES FOR BIG
PHYSICS AREA CAN MOVE TO SMALL,
AND LARGE-SIZED PHYSICS
APPLICATIONS PART OF WHAT OUR
COMMUNITY REALLY ADVANCES.
AND THERE'S MATERNAL HEALTH
WEBINAR AND WORKSHOP.
THERE'S TWO OF THEM COMING UP.
THE FIRST ONE'S IN FEBRUARY.
THIS IS VIRTUAL.
THIS IS REALLY ORIENTED AROUND
SMALL BUSINESS OPPORTUNITIES FOR
DIAGNOSTICS TECHNOLOGIES IN
MATERNAL HEALTH.
THE SECOND IS A HYBRID WORKSHOP.
IT'S ACTUALLY ALIVE IN PERSON IF
YOU REMEMBER THE CENTER WHERE WE
ALWAYS HAD WORKSHOPS IS BEING
REINVIGORATED AND WE AAA -- A
LEAD ON THIS AND THIS IS TRYING
TO ADVANCE TECHNOLOGIES IN
MATERNAL HEALTH.
A FEW PROGRAM UPDATES.
THE FIRST IS IN DEVELOPING
QUANTITATIVE IMAGING OF BIO
FACIAL TISSUES.
YOU HEARD US TALKING ABOUT THIS.
THIS IS RESEARCH SUPPORTED BY
THE HEAL INITIATIVE.
WHEN THE HEAL INITIATIVE WAS
FIRST ANNOUNCED WE THOUGHT THERE
WERE NATURAL PARTNERSHIPS THAT
MAYBE COULD BRING IMAGING MORE
EFFECTIVELY INTO THE HEAL
PROGRAM AS WELL AS OTHER
TECHNOLOGIES AND IN FACT THEY'RE
SOLID PROGRAMS AND WE'RE EXCITED
TO ANNOUNCE THE FIRST ROUGHLY $5
BILLION, $5.3 -- $5 MILLION UP
TO $5.3 MILLION IS FOR OPTICAL
IMAGING AND ACOUSTICS REFLECT
THE NEED TO HAVE BETTER IMAGING
CHARACTERIZATION OF TISSUES
DIRECTLY IMPACTFUL IN HOW ONE
WOULD DO CLINICAL PAIN
MANAGEMENT.
LOTS OF ENTHUSIASM AND THINK THE
AREA WILL CONTINUE TO GROW.
THIS PROGRAM HAS TAKEN OFF.
IT'S ACCELERATED OVER THE PAST
SIX MONTHS THERE'S IMAGING
STUDIES OF APPROXIMATELY 70,000
STUDIES RELEASED.
THIS HAPPENED OVER THE PAST SIX
MONTHS.
105,000 IMAGING STUDIES
AVAILABLE AND OUT TO THE PUBLIC.
THERE'S BEEN MORE THAN AN 8
TERABYTE OF IMAGING DATA AND ALL
THIS IS MAPPED ON TO LINK.
IT'S REALLY THE INFORMATION
CONTENT IS QUITE ACCESSIBLE AND
FACILITATES COHORT BUILDING AND
INTRAOPERABILITY OF DATA SENSE.
THERE'S A LOT OF GROWING
MOMENTUM FOR ADOPTION.
WE HAVE SIGNIFICANT GROWTH IN
USERS, 350 USERS.
A GROWTH OF ALMOST 170 USERS
OVER SIX MONTHS FROM 252
INSTITUTIONS, PUBLICATIONS HAVE
GROWN AND IMPORTANTLY THE DATA
SET FOR THE SEQUESTERED DATA SET
HAS NOW GROWN TO 20,000 IMAGING
STUDIES.
THAT'S ALSO EXPANDED QUITE
SIGNIFICANTLY OVER SIX MONTHS.
AND THIS IS ALL DRIVEN BY THE
DATA INGESTION MODEL HAS ACR,
RSNA AND AAPF.
RAPID INGESTION AND DATA
CURATION AND THERE'S AN EXPANDED
POPULATION OF PEOPLE WORKING ON
THEM AND THERE'S WAYS TO
LEVERAGE THE COMMUNITY'S
EXPERTISE WITH GRAND CHALLENGE.
THE FIRST GRAND CHALLENGE WAS
ANNOUNCED AND COMPETED AND THE
WINNERS WERE ANNOUNCED AT THE
RSNA MEETING AT THE END OF
DECEMBER IN 2022.
EXCITING TO SEE THAT THE
ALGORITHM THAT WON AND SORT OF
THE BOTTOM LINE IS THE AUC, THE
AREA UNDER THE CURVE WAS THE
HIGHEST AND ALL THE ALGORITHMS
THAT COMPETED.
THAT AUC BEAT EXPERT REVIEWER
VALIDATION AS COMPARED TO THE
VALIDATION DATA SET.
SO THIS IS PRETTY NEAT.
THE WINNING CODE IS ACTUALLY
POSTED ON THE GITHUB WEBSITE.
AND WE SEE THIS IS A REALLY
WONDERFUL OPPORTUNITY TO INSPIRE
ACTIVITY NOW THAT THERE'S ALL
THIS DATA OUT THERE.
PEOPLE ARE ENGAGED AND
INTERESTED.
WE'LL SEE MORE OF THESE TYPES OF
GRAND CHALLENGES.
THIS SAY BIT OF A BUSY SLIDE.
THE DEBUT AWARDS AND IS
EXTREMELY FOR ME TO ADVERTISE
THE POWER AND ENTHUSIASM FOR
THIS PARTICULAR PROGRAM.
WE'VE NOW INCREASED THE TOTAL
PRIZES TO $145,000.
THE MOST RECENT ADDITION HAS
BEEN A SPECIAL AWARD
TECHNOLOGIES TO EMPOWER NURSES
IN COMMUNITY SETTINGS.
WE WANT YOU TO REALLY FOCUS ON
THAT.
SPREAD THE WORD ABOUT THAT
AVAILABILITY.
THESE ARE JUST SOME PHOTOS ON
THE LEFT OF GIVING AWARDS AT THE
BMES MEETING.
THE NEXT AWARDS WILL BE GIVEN IN
THE FALL AT THE BMES MEETING IN
SEATTLE.
AND WE TYPICALLY HAVE SOMEWHERE
AROUND 450 MAYBE 500
PARTICIPANTS AROUND THE COUNTRY
FROM 75 OR 80 DIFFERENT ACADEMIC
INSTITUTIONS OR INSTITUTIONS IN
GENERAL.
WE HOPE TO REALLY EXPAND THAT.
WE NEED ALL OF YOUR HELP TO GET
THE WORD OUT.
NOW IS THE TIME.
DESIGN TEAMS ARE WORKING ON
PROJECTS.
WE ENCOURAGE THEM TO PLEASE TO
FIND THERE'S SO MANY CATEGORIES.
SOMEONE WILL FIND A GOOD MATCH
AND THE CHANCES OF WINNING IN
ANY CATEGORY ARE PRETTY GOOD.
IT'S NOT LIKE THE LOTTERY.
PLEASE ENCOURAGE YOUR STUDENTS
AND YOUR TEAMS TO APPLY.
THE TOP PRIZE $20,000 AND JUST
TO UNDER SCORE, THESE PRIZE
FUNDS GO DIRECTLY -- THE AWARDS
GO DIRECTLY TO THE STUDENTS.
A FEW RADX APPLICATION UPDATES
ARE INNOVATION FUNNEL.
YOU HEARD IN THE LAST COUNCIL
MEETING OF RADX IN THE INFLUENCE
AND IN OUR EXPANDING
PARTNERSHIPS WITH OTHER
INSTITUTES AND CENTERS.
OUR INNOVATION FUNNELS THERE'S
FOUR IN PROGRESS IN VARIOUS
STAGES.
THE TECH 3 NEXT GEN COVID AND
WE'LL HAVE AN UPDATE IN MINUTES.
THERE'S A BLUE MISPRINT MEDTECH
FUNNEL A MATERNAL HEALTH
INNOVATION FUNNEL ALSO IN
PROGRESS.
THESE ARE IN DEEP-DIVE STAGES OR
SHARK TANK STAGES AND EMERGING
HIV/AIDS FUNNEL LOOKING AT VIRAL
LOAD TESTING AND TREATMENT OF
ASSESS INFECTIOUSNESS.
OUR RADX PROGRAM HAS
SIGNIFICANTLY EXPANDED IN MONKEY
POX THERE'S ONGOING TEST
DEVELOPMENT.
WE HAVE MULTIPLEX RESPIRATORY
TEST TO ACCELERATE THEIR
INNOVATION AND WE HAD NEW
EMERGENCY USE AUTHORIZATION
GRANTED IN THIS AREA AND KEEP
YOUR EYES OPEN FOR A NEW VIRAL
CARE POINT OF TEST WITH HIGH
NATIONAL PUBLIC HEALTH AND
NATIONAL IMPORTANCE.
THAT WILL BE A PENDING
ANNOUNCEMENT SOON.
WE FEEL THESE ARE POWERFUL
MECHANISMS FOR TAKING THE BASIC
PROCESSES THAT WE'VE DEVELOPED
AND EXPANDED FOR COVID AND
MOVING THEM INTO OTHER AREAS.
IN TERMS OF IMPACT, A QUICK
UPDATE ON THAT.
WE'LL PROBABLY STOP COUNTING ON
THE EUAs BECAUSE THE NUMBERS
HAVE GOTTEN SO CRAZILY HIGH.
AS OF LAST COUNT THROUGH THE END
OF 2022, RADX SUPPORTED
COMPANIES HAVE CONTRIBUTED 6. 7
BILLION TESTS TO THE NATIONAL
CAPACITY.
THAT'S THE INCREASE IN TESTING
THROUGH THE COMPANIES WE HAVE
SUPPORTED THROUGH INVESTMENT.
REALLY QUITE A SUBSTANTIAL
IMPACT IN TERMS OF THE NUMBERS.
MOST RECENTLY THERE'S BEEN ALSO
PROGRAMMATIC ADVANCES THAT HAVE
BEEN WHAT I THINK ARE QUITE
TRANSFORMATIONAL AND THAT'S WHY
WE HAVE ANDREW WEITZ AND KRISHNA
JULURU GIVING A SPECIAL
PRESENTATION ON THIS.
THESE INCLUDING THE DEVELOPMENT
YOU HEARD ABOUT IN COUNCIL
MEETINGS AND POSSIBLY IN TALKS
ABOUT DIGITAL PLATFORMS AND A
HOME TEST TO TREAT PROGRAM AND
IF YOU LOOK DOWN ON THE LOWER
RIGHT HAND CORNER YOU'LL SEE A
BLUE BUTTON THAT SAYS REPORT
TEST RESULTS.
THAT'S ACTUALLY ON THE NATIONAL
COVID.gov WEBSITE THIS SIMPLE
BUTTON HAS TAKEN AN ENORMOUS
AMOUNT OF WORK AND TIME TO GET
POSTED ON THE WEBSITE AND WE'LL
EXPLAIN MORE ABOUT THAT.
LET'S JUST SAY GOING BACK A
COUPLE YEARS THE THINKING WAS
THIS WOULD NEVER BE RECORDED.
NOBODY WANTED THIS KIND OF
INFORMATION AND ANDREW AND
KRISHNA WILL GIVE STORY ON HOW
ALL OF THIS MARCHED TO COME TO
FRUITION.
THESE ARE SIGNIFICANT
ACHIEVEMENTS AND WE'LL HAVE A
SEPARATE PRESENTATION IN
MINUTES.
FIRST JILL, CAN I HAND IT OVER
TO YOU TO TALK ABOUT
ACCESSIBILITY AND UPDATES ON
THAT.
THANK YOU, BRUCE.
THIS WAS STIMULATE FROM ADVOCACY
FROM OUTREACH GROUPS ASKING THE
GOVERNMENT FOR HOME TESTS TO BE
USED INDEPENDENTLY FOR PEOPLE
WITH BLINDNESS OR ACCESSIBILITY.
THIS WAS A WAKE-UP CALL FOR US
BECAUSE IN MAKING LARGE VOLUMES
AVAILABLE AS QUICK POSSIBLE WE
NEGLECTED TO LOOK TO UNIVERSAL
DESIGN AND AS WE BEGAN IT THINK
ABOUT HOW WE WOULD PROCEED WE
BEGAN TO REALIZE THERE'S LITTLE
INFORMATION AND GROUND WORK ON
WHAT ACCESSIBILITY MEANS IN THE
HOME MEDICAL DEVICE SPACE.
WE STARTED WITH CONVENING A
LISTENING SESSION WITH
GOVERNMENT AGENCIES WHO HAD
ACCESSIBILITY AS PART OF THEIR
MISSION.
RUN BY THE LEADERSHIP OF THE
RADX CENTER AND COORDINATING
BOARD.
WE HAD THREE TYPES OF ADVOCACY
GROUPS REPRESENTED PEOPLE WITH
BLIND, MOTOR IMPAIRMENTS AND
OLDER ADULTS.
AND THERE'S DIFFICULTY IN THE
TEST AND LOOKING AT PRECISE
LIQUID TRANSFER AND DIFFICULTY
INTERPRETING THE RESULT FROM THE
TEST STRIP.
WHILE THE MESSAGES WERE COMING
TO US FROM DISABILITY ADVOCATES,
THESE ARE CHALLENGES WE MUST ALL
OF US HAVE WITH THESE TESTS
CURRENTLY ON THE MARKET.
WHAT WE DID TO ADDRESS THIS IS
THE DEPLOYMENT CORPS ASSEMBLED
REPRESENTATION AND ENGAGED 17
DESIGNERS AND REVIEWS FROM THE
BLIND AGING AND MOTOR IMPAIRMENT
POPULATIONS.
AND THE PROST US WITH SUBJECT
MATTER EXPERTISE TO GO THROUGH
THE PROCESS WAS SET UP IN THE
DEPLOYMENT CORPS FOR EVALUATING
AND MODERATING TESTS.
EVALUATION STARTS AT HOMELAB AT
GEORGIA TECH WHERE THEY DO A
VERY DETAILED EXAMINATION OF
DOZENS OF DIFFERENT ASPECTS OF
TAKING THE TEST ALL THE WAY FROM
OPENING THE WORK TO THROWING
AWAY THE USED TEST AT THE END.
THEY TOOK EXTENSIVE INPUT FROM
THE SUBJECT MATTER EXPERTS.
THE CHALLENGES IDENTIFYING THE
GREAT DETAIL WE WENT TO DESIGN
FIRMS WHO WORKED WITH THE
EXPERTS TO DESIGN POSSIBLE
SOLUTIONS.
WE THEN ARE WORKING WITH
COMPANIES AND DESIGN FIRMS AND
SUBJECT MATTER EXPERTS TO COME
TO AGREEMENT ON WHICH SOLUTIONS
ARE AMENABLE TO EVERYBODY THAT
WOULD POINT PROTOTYPES PRODUCED
AND VALIDATED AGAIN WITH THE
EXPERTS AND WE'RE SUPPORTING
THOSE COMPANIES TO MAKE THE
CHANGES.
BRUCE, WHAT WE REALIZED IN
SETTING UP THE INFRASTRUCTURE
THAT WAS SO VALUABLE AND THE
GOVERNMENT AND SUBJECT MATTER
EXPERTS AND MANUFACTURERS AND
REGULATORS, WE JUST LEARNED SO
MUCH AND STARTED TO BECOME
CONCERNED AFTER THE PROGRAM WENT
AWAY ALL OF THIS LEARNING WAS
GOING TO BE LOST.
SO I'M HAPPY TO ANNOUNCE WE
PUBLISHED BEST PRACTICES FOR THE
DESIGN OF ACCESSIBLE TESTS.
IT CAPTURES THE LEARNINGS TO
DATE FROM THE ACCESSIBILITY
INITIATIVE AND THE TARGET
AUDIENCE FOR THIS IS THE
COMPANIES MAKING TESTS AND
DESIGNERS AND ENGINEERS.
IT COVERS A WIDE RANGE OF
CONSIDERATIONS QUITE GENERAL
ACROSS THE HOME MEDICAL DEVICE
ENTERPRISE.
LIKE PACKAGING, FORMATS FOR
INSTRUCTIONS.
USER INTERFACES.
ABOUT 80% OF WHAT'S IN HERE IS
REALLY GENERALIZABLE TO JUST ANY
HOME MEDICAL DEVICE.
WHAT WE'RE HOPING IS THIS NOW
WILL MAKE AVAILABLE TO INDUSTRY
A GENERAL ROAD MAP FOR HOW TO
MAKE DEVICES MORE ACCESSIBLE.
IT'S BEING HOSTED ON THE
U.S. ACCESS BOARD WEBSITE.
THAT'S THE U.S. AGENCY
RESPONSIBLE FOR IMPLEMENTING THE
ACCESSIBILITY GUIDELINES UNDER
THE AMERICANS WITH DISABILITIES
ACT.
THIS IS A NICE ADDITION TO THEIR
PORTFOLIO.
YOU CAN ALSO -- THE WAY I GET TO
IT IS SEARCH UNDER RADX BEST
PRACTICES ON GOOGLE AND COMES UP
ON THE FIRST HIT AND ON THE NEXT
SLIDE I CAPTURED AN EXAMPLE OF
WHAT THIS LOOKS LIKE.
THIS IS A 92-PAGE DOCUMENT THAT
COVERS MANY ISSUES AND
RECOMMENDATIONS FOR THEIR
SOLUTION IN THIS FORMAT OF
HERE'S THE ISSUE, HERE'S THE
RECOMMENDATION.
SIMPLE GRAPHICS.
SIMPLE PLAIN LANGUAGE,
DESCRIPTIONS AND RECOMMENDATIONS
AND IN THIS IS CASE THE SWAB TIP
IS AT THE END WHERE IT'S OPEN
AND YOU CAN MAKE THE OPENING
BIGGER SO IT'S EASIER TO OPEN.
IT'S REALLY NOT ROCKET SCIENCE
BUT IT'S BEAUTIFUL IN ITS
SIMPLICITY AND ACCESSIBILITY.
IF YOU GO TO THE NEXT SLIDE TO
ANSWER THE QUESTION WHEN ARE WE
GOING TO START SEEING MORE
ACCESSIBLE TESTS ON THE MARKET,
THIS TEST MODIFICATION PIPELINE
WE HAVE WE'RE WORKING WITH 12
DIFFERENT COMPANIES.
SOME OF THESE MODIFICATIONS THAT
HAVE BEEN RECOMMENDATIONS BY OUR
ENGINEERS HAVE ALREADY BEEN
IMPLEMENTED AND ARE APPEARING IN
TESTS THAT ARE ON THE SHELVES.
THEY'RE NOT ALWAYS JUMPING OUT
AT YOU.
THINGS LIKE CHANGING THE CAP
COLOR DIFFERENT FROM THE TUBES
TO SEE IT'S DIFFERENT AND
INTERPRETATIONS FOR THE READER
AND WE'LL ROLL OUT DIFFERENT
MODIFICATIONS AS WE WORK WITH
MANUFACTURERS OVER THE NEXT 2 TO
12 MONTHS.
WE'RE ESPECIALLY EXCITED ABOUT
AN EUA WE'RE ABOUT TO SUBMIT TO
THE FDA THIS WEEK.
ONE COMPANY HAS A NOVEL, SIMPLE
DESIGN.
I'M LOOKING FORWARD TO SEEING
THAT COME TO MARKET.
IN PARALLEL WE ALSO HAVE THE
RADX TECH 3 INNOVATION FUNNELS
BRUCE MENTIONED OF THE
ACCESSIBLE TEST FUNNEL WHICH
RECEIVED 51 APPLICATIONS THAT
ARE UNDERGOING REVIEW RIGHT NOW.
THIS WILL ALLOW MANUFACTURERS
RATHER THAN MODIFYING EXISTING
TEST DESIGN, DESIGN A TEST WITH
ACCESSIBILITY AS A FOREMOST
CONCERN FROM THE OUTSET.
THIS WOULD BE BASED ON CURRENT
TECHNOLOGY AND SO WE'RE HOPING
THINGS WILL COME TO THE MARKET
AT LEAST COME TO THE FDA FOR EUA
OVER THE NEXT 12 TO 18 MONTHS.
AND ONE IMPORTANT ASPECT OF THE
HIGH PERFORMANCE TEST FUNNEL FOR
WHICH WE RECEIVED 167
APPLICATIONS IS ACCESSIBILITY OF
THE DESIGN IS INCLUDED AS A
REQUIREMENT.
AND THESE TESTS BEING BASED ON
NEW TECHNOLOGIES AND BE LAB
PERFORMANCE TESTS FOR THE HOME
COME OVER A THREE-YEAR TIME
LINE.
WE'RE HOPING ALL THIS CONTINUAL
PUSH COMING FROM RADX TO BRING
MORE AND MORE ACCESSIBLE TEST TO
MARKET WILL TAKE HOLD ACROSS THE
INDUSTRY AND THAT WE WILL SLOWLY
SEE A TRANSFORMATION TO THE
POINT WHERE ACCESSIBILITY
BECOMES AN UNPROMPTED THING THAT
TEST DEVELOPERS DO MOVING
FORWARD.
SO JUST WANTED TO UPDATE YOU ON
THE NEW PRACTICE GUIDELINES AND
I'LL STOP THERE AND TURN IT BACK
TO YOU, BRUCE.
>>THANK YOU, JILL.
JILL, YOU MENTIONED THIS IS
IMPORTANT FOR INDUSTRY.
OF COURSE, IT'S REALLY CRITICAL
FOR INDUSTRY BUT IT'S NEVER TOO
SOON FOR THOSE OF US IN
LABORATORIES DESIGNING VARIOUS
TECHNOLOGIES TO TAKE A LOOK AT
THIS.
I KNOW AS I READ THROUGH IT AND
I START TO THINK ABOUT SOME OF
THE BASIC PRINCIPLES POINTED OUT
AND HOW IT MIGHT BE EXTRAPOLATED
TO THE TYPES OF DEVICES AND
TECHNOLOGIES I SPENT MY CAREER
BUILDING AND I THINK MANY PEOPLE
WOULD BE INSPIRED IN SIMILAR
WAYS IN ACADEMIC LABS.
I THINK WITH I'M GOING STOP
SHARING AND INVITE ANDREW AND
KRISHNA TO COME ON WITH THEIR
PRESENTATION.
THEY'RE GOING TO RUN THE SHOW
AND HIS IS THE SECOND PART OF
THE RADX PRESENTATIONS.
HANDING IT OVER TO YOU GUYS.
>>THANK YOU, BRUCE.
GOOD AFTERNOON, EVERYONE.
I'M ANDREW WEITZ.
>>I'M KRISHNA JULURU AND ON THE
TEAM FOR RADX.
TODAY WE'RE GOING TO BE TALKING
ABOUT THE LEADING ROLE THAT
NIBIB PLAYED IN ENABLING PEOPLE
WHO TEST AT HOME FOR COVID TO BE
ABLE TO REPORT THEIR RESULT TO
PUBLIC HEALTH AND RECENTLY HOW
WE'RE ENABLING PEOPLE TO TEST
POSITIVE FOR COVID TO RECEIVE
ACCESS TO THERAPEUTICS AT HOME
WITHOUT EVER HAVING TO LEAVE
THEIR HOMES.
>>WE'RE GOING TO BE PRESENTING
JOINTLY AND WE'LL BE ASKING
IMPROMPTU QUESTIONS ALONG THE
WAY.
HERE'S AN ARTICLE FROM EARLY
JANUARY, 2022.
THIS IS AMIDST THE OMICRON WAVE.
YOU WOULD GO TO SCORES AND BUY
THEM OFF STORE SHELVES BUT DID
NOT HAVE AN EASY WAY TO REPORT
OUR COVID TEST RESULTS.
THIS PRESENTED A MAJOR BLIND
SPOT.
PUBLIC HEALTH AGENCIES HAD BEEN
USED TO GET TESTING DATA FROM
LABORATORIES AND DOCTORS
OFFICES.
NOW THE MAJORITY OF TESTING
SHIFTED INTO THE HOME SETTING
AND WITHOUT WAYS TO REPORT THE
RESULTS, THERE WAS NO WAY TO
FULLY TRACK THE AMOUNT OF COVID
CASES THROUGHOUT THE COUNTRY.
SOME HEALTH DEPARTMENTS GOT
PROACTIVE AND STOOD UP WEBSITES
THAT WOULD ALLOW THE RESIDENTS
TO SELF-REPORT THEIR AT-HOME
TEST RESULTS.
BUT NOT ALL HEALTH DEPARTMENTS
SAW EYE TO EYE ON THE VALUE ON
THE TESTS.
TO THIS DAY ONLY HALF OF THE
STATE HEALTH DEPARTMENTS OPTED
TO RECEIVE AT HOME TESTING.
>>WHY WOULD A STATE NOT WANT TO
RECEIVE DATA FROM AN AT-HOME
TEST.
>>IF YOU COMPARE THEM TO LAB
AND POINT OF CARE DATA THEY'RE
MESS
MESSIER.
IN THE LAB IT'S ADMINISTERED BY
A HEALTH CARE PRACTITIONER AND
CAN HAVE MORE CONFIDENCE THE
INFORMATION BEING REPORTED WITH
THE TEST RESULT WHICH WOULD BE
FOR EXAMPLE THE NAME, ADDRESS OF
THE PATIENT, DEMOGRAPHICS, ALL
THAT'S GOING TO BE ACCURATE.
WHERE WITH AT-HOME TEST AND
SELF-REPORTING MAYBE THE PERSON
MADE THE MISTAKE IN HOW THEY
ADMINISTERED THE TEST OR THE
ADMINISTRATION AND NAME,
ADDRESS, PHONE NUMBER HAD TYPOS
IN IT OR WAS INACCURATE
ALTOGETHER.
THE HEALTH DEPARTMENTS THAT HAD
NOT BEEN INTERESTED IN THE DATA
THEIR STANCE BECAUSE IT'S TOO
MESSY AND DON'T HAVE ENOUGH
CONFIDENCE IN THEM.
THIS WAS A STUDY RAN IN EARLY
2021 WHEN TESTS WERE WIDELY
AVAILABLE AND THERE WERE SMART
PHONE APPS AND BY AND LARGE
PEOPLE WERE INTERESTED IN USING
APPS, MOBILE PHONE APPS WITH THE
TESTING PROCESS.
WE FOUND 98% OF PARTICIPANTS IN
OUR STUDY FOUND THEM USEFUL FOR
PERFORMING THE TESTS AND WOULD
RECOMMEND THE APP TO OTHERS.
WE THEN BEGAN TO EXPLORE THE
ROLE AND WE RAN AN INITIATIVE
CALLED SAY YES COVID TEST WE
ADMINISTERED TO RESIDENTS ACROSS
THE COUNTRY AND GAVE PEOPLE THE
OPTION TO USE A MOBILE PHONE
APPLICATION TO ASSIST WITH THE
PROCESS AND TO VOLUNTARILY
REPORT THEIR AT-HOME TEST
RESULTS IF THEY WANTED TO DO SO.
THE BARS INDICATE PEOPLE'S
WILLINGNESS REPORT OR NOT REPORT
THEIR AT-HOME COVID TEST RESULTS
WHEN INVITED TO DO SO BY THE
MOBILE PHONE APP AND WE FOUND
THREE IN FOUR INDIVIDUALS, 75%
OF PEOPLE, WHEN ASKED BY THE APP
DO YOU WANT TO REPORT YOUR COVID
TEST RESULTS TO PUBLIC HEALTH
AGREED TO DO SO.
THE AGREEMENT TO REPORT DIFFERED
WHETHER SOMEONE TESTED NEGATIVE
OR POSITIVE.
FEG TIF ALMOST 80% REPORTED AND
WHEN TESTING POSITIVE, 16% OF
INDIVIDUALS REPORTED RESULTS.
>>DOES THIS MEAN 3/4 OF AT HOME
TESTS HAVE REPORTED RESULTS?
>>IT'S NUANCED.
IF SOMEONE IS USING AN APP TO
ASSIST WITH THE TESTING PROCESS
AND WHEN THEY GET TO THE SCREEN
IN THAT APP THAT SAYS ARE YOU
WILLING TO REPORT YOUR TEST
RESULTS IN PUBLIC HEALTH 3 IN 4
INDIVIDUALS AGREED TO DO SO.
LET'S TALK ABOUT THE REGULATORY
LANDSCAPE HERE.
NIBIB, RADX TECH HAS INTEREST IN
CAPTURING THE DATA FROM HOME
TESTS.
ONE THING WE HAD WORKING TO OUR
ADVANTAGE IS FDA SET A
REQUIREMENT FOR ALL TEST
MANUFACTURERS TO DEVELOP A
MOBILE PHONE APPLICATION OR
WEBSITE TO FACILITATE RESULTS OF
REPORTING BY CUSTOMERS.
WE HAD ALL THESE OVER THE
COUNTER TEST MANUFACTURERS
SCRAMBLING TO GET THESE MOBILE
PHONE APPS TOGETHER TO
FACILITATE REPORTING.
IT WAS NOT AN EASY THING TO DO.
ONE OF THE REASONS IS BY VIRTUE
OF OUR NATION'S HEALTH I.T.
INFRASTRUCTURE SO THERE ARE
ABOUT 65 DIFFERENT STATE AND
LOCAL HEALTH JURISDICTIONS
ACROSS THE COUNTRY.
EACH ONE HAS ITS OWN I.T.
INFRASTRUCTURE AND IT'S CLEARLY
NOT FEASIBLE TO HAVE THEM HAVE
AN INDIVIDUAL CONNECTION TO ALL
THESE DIFFERENT JURISDICTIONS.
MOREOVER IT WASN'T CLEAR TO
MANUFACTURERS WHAT DATA SHOULD
BE CAPTURED AND WHERE IT SHOULD
BE SENT.
>>WHO ARE THESE PEOPLE AND WHY
DO THEY LOOK TO FRUSTRATED?
>>THIS WOMAN ON THE LEFT WHO
WORKS FOR A TEST MANUFACTURER
RECEIVED AN EUA FOR A HOME COVID
TEST BUT HAPPY BUT SHE'S
FRUSTRATED BECAUSE SHE'S
CONFUSED HOW TO ENABLE THE
REPORTING CAPABILITIES THROUGH A
MOBILE APP.
SHE'S NOT SURE WHAT INFORMATION
NEEDS TO BE CAPTURED THERE THE
USER IN ADDITION TO THE TEST
RESULT.
SHE'S NOT SURE HOW TO ENCODE
THAT INFORMATION IN A CERTAIN
FORMAT THAT WOULD BE COMPATIBLE
WITH HEALTH SYSTEMS AND NOT SURE
HOW TO SEND THAT INFORMATION TO
THE RIGHT HEALTH SYSTEMS.
ON THE RIGHT WE HAVE A GENTLEMAN
WHOSE HEALTH SYSTEM HAS BEGUN TO
RECEIVE DATA FROM THE APPS AND
HE'S JUST RECOGNIZED NONE OF THE
DATA ARE INTEROPERABLE AND
THEY'RE SENDING INFORMATION IN
DIFFERENT FORMATS AND HE CAN NO
LONGER ABROGATE THE DATA
TOGETHER TO RUN THE ANALYSIS.
SUMMARIZING WHERE WE WERE AND
WHAT ISSUES WE WERE FACED WITH,
THE AMOUNT OF TESTING AT HOME
FAR SURPASSED WHAT WAS EXPECTED
WE HAD 2 MILLION HOME TESTS
PRODUCED IN 2022 BUT THERE'S
CHALLENGES IN CAPTURING DATA.
THERE WAS A LACK OF STANDARDS TO
REPRESENT AND TRANSMIT THE
RESULTS.
THERE WAS INCOMPLETE GUIDANCE ON
WHAT INFORMATION TO CAPTURE AND
DIFFERENT USE WHETHER OR NOT
THEY WOULD ACCEPT THE HOME TEST
RES
RESULTS.
AND FINALLY, BECAUSE THERE'S SO
MANY DIFFERENT JURISDICTIONS AND
NO EASY TO ESTABLISH A
CONNECTION TO EACH, THERE'S
SERVICES OUT THERE THAT WOULD
RELY TEST RESULT MESSAGES FROM
THE MOBILE APPS TO THE PROPER
JURISDICTION.
THE ISSUE IS THE SERVICES CHARGE
COSTS FOR EVERY MESSAGE SENT.
EVERY TIME A TEST
MANUFACTURER -- ANYTIME USED
THEIR APP TO REPORT A RESULT THE
MANUFACTURER HAD TO PAY A FEE
AND THAT WAS SERVING AS A
DISINCENTIVE TO PROMOTE HOME
RECORDING
>>HAVEN'T LABORATORIES BEEN
REPORTING TO PUBLIC HEALTH FOR
DECADES?
>>YES, FOR DECADES AND THERE
ARE STANDARDS AND REGULATIONS
THAT REQUIRE HOW LAB TEST
RESULTS ARE AFFORDED.
THOSE REGULATIONS DO NOT APPLY
TO THE HOME SETTING AND THE
STANDARDS DO NOT REGULARLY
TRANSMIT TO THE HOME SETTING.
>>THIS IS A GREAT TRANSITION TO
THE THE MARS RADX PROGRAM IT'S A
SET OF SERVICE TO ADDRESS THE
CHALLENGES.
THE PROGRAM NAVIGATES THROUGH A
REPORTING LANDSCAPE AND SETS A
HEALTH CARE INDUSTRY STANDARD
FOR TEST RESULTS DATA AND
PROVIDES NIH FUNDING TO COVER
THE COST OF REPORTING AND
PROMOTES DATA HUBS TO LESSEN THE
BURDEN OF COMPLEX CHANNELS FOR
COMMUNICATION.
LET'S TAKE A CLOSER LOOK AT WHAT
THIS MIGHT LOOK LIKE.
WE'RE SHOWING THE DATA FOR TEST
RESULT.
ON THE LEFT ARE VARIOUS
COMPANIES AND TESTS THEY
MANUFACTURE.
COMPANY A AND B, C AND D.
THOSE TESTS CAN BE TAKEN BY A
VARIETY OF USERS.
THEY MAY BE USING A VARIETY OF
DIFFERENT MOBILE APPLICATIONS.
REGARDLESS OF THE TEST TAKEN OR
MOBILE APPLICATION USED THE
INDIVIDUALS AGREE FOR AN
INDIVIDUAL WHO EXTENDS THE
RESULTS AND THEY GET PACKAGED IN
A STANDARD WAY WHICH IS WHAT IS
THE DATA COMMUNICATION AND THE
HUB HERE IS DIFFERENT THAN THE
HUBS WE THINK ABOUT IN MORE
TRADITIONAL RESEARCH SETTINGS.
WE THINK OF HUBS AS LONG-TERM
DATA REPOSITORIES.
HERE IN THE CONTEXT OF MARS IT'S
A RELAY POINT OR POINT OF A
NETWORK THAT HELPS RELAY
INFORMATION TO DOWN STREAM
SYSTEMS.
THOSE ARE THE SYSTEMS WITH A
VARIETY OF SYSTEMS THAT MAY USE
THE DATA.
THE HUB HAS PREESTABLISHED RULES
TO KNOW WHEN A MESSAGE COMES
FROM AN INDIVIDUAL IN A CERTAIN
STATE, WHICH IS WHAT THEY
REPORTED, IT WOULD SEND THOSE
RESULTS DOWNSTREAM AND SEND
OPERATIONS DOWN.
>>IS THIS THE SAME DATA FLOW
LABORATORIES USE?
>>SIMILAR BUT AN IMPORTANT
DISTINCTION.
THREES AN IMPORTANT PARADIGM
SHIFT AND IF A STATE ACCEPTS THE
DATA AND THAT DATA MAKES IT WAY
TO THE STATE HEALTH SYSTEM THEN
THE STATE HEALTH SYSTEM BASED ON
ITS OWN POLICIES AND PROCEDURES
CHOOSES WHICH DATA TO SEND
DOWNSTREAM TO THE FEDERAL SYSTEM
KNOWN AS HHS.
THE DATA GETS DE-IDENTIFIED IN
THE PROCESS.
WE HAVE A DATA STREAM WHERE IT'S
DE-IDENTIFIED AND SENT ON.
IN THIS WAY WE AVOID THE BOTTLE
NECKS AND ELIMINATE A BLIND
SHOT.
IN THE PROCESS OF THE STANDARDS
AND PIPELINES WE UNDERSTAND SOME
APP DEVELOPERS NEEDED GUIDANCE
HOW TO DESIGN THE USER WORK
FLOW.
WE FOUND ENOUGH VARIABILITY IN
THE FRONT END USER WORK FLOW.
SO WE DEVELOPED HIGH END SCHEMA
FOR HELPING DEVELOPERS DESIGN
THE WORK FLOW AND BASED IT ON A
COUPLE CONCEPTS WHAT THE
INFORMATION INCLUDES.
IT INCLUDES THE REQUIRED DATA
ELEMENTS IN THE GREEN BAR AND
INCLUDES AGE AND ZIP CODE.
SOME OPTIONAL ELEMENTS INCLUDE
SEX, RACE AND ETHNICITY AND
PERSONALLY IDENTIFIABLE
INFORMATION DATE OF BIRTH AND
ADDRESS.
RADX BUILDS UPON EXISTING
SYSTEMS.
THIS IS AN IMPORTANT POINT.
WE DIDN'T REINVENT THE WHEEL.
WE LOOKED AT THE WAY HEALTH CARE
DATA WAS FLOWING IN OTHER
SETTINGS AND ADAPTED THAT TO THE
MOBILE PHASE AND THE OFFICE OF
THE NATIONAL COORDINATOR
COLLABORATED TO DEVELOP HL7
HEALTH LANGUAGE FOR CAPTURING
THE RESULTS TO DOWN STREAM
SYSTEMS.
THESE SPECIFICATIONS CONFORM TO
FEDERAL AND STATE GUIDELINES FOR
THIS AND IF THEY FOLLOW THE
SPECKS WE CAN GUARANTEE TO THEM
THEIR SYSTEMS WILL ACCEPT IT.
AND CURRENTLY UNDERGOING THE
PROCESS AND ITS STANDS FOR FAST
INTEROPERABILITY RESOURCES
BETWEEN MODERN HEALTH CARE
INFORMATION PREFERRED BY
DEVELOPERS AND WE'RE GOING
THROUGH A PROCESS AND FINALLY
THE PROCESSES LEND THEMSELVES
FOR DOWN STREAM OPERATION.
THERE'S POSSIBILITIES POR
DUPLICATE DATA STREAMS HITTING
THE FINAL HHS PROTECT AND SET UP
MECHANISM TO MAKE SURE THE SAME
THEFT COMING TO MULTIPLE DATA
STREAMS WON'T BE HANDLED TWICE.
LET'S HAVE A LOOK AT THE
TECHNICAL DETAILS AND HERE'S AN
IS SCREEN CAPTURE FROM A SUITE
THAT DESCRIBE THE WHOLE PROCESS
AND SPECIFICATIONS.
ONE IS KNOWN AS AN IG AND WE
PROVIDE A TABLE AND WHAT YOU'RE
SEEING IS A SCREEN CAPTURE
SHOWING ELEMENT BY ELEMENT WHAT
ARE THE DATA FIELD AND WHAT ARE
THE EXPECTED VALUES.
USE SEE ALL THE DATA IF YOU
SCROLL DOWN.
HERE'S WHAT THE MESSAGE MIGHT
LOOK LIKE.
>>KRISHNA, THIS LOOKS
COMPLICATED.
I REMEMBER YOU SAYING ALL WE'RE
CAPTURING IN ADDITION TO THE
TEST RESULT IS THE AGE AND ZIP
CODE OF THE INDIVIDUAL.
LET'S REMEMBER OUR GOAL.
THOSE HEALTH SYSTEMS RECEIVE
DATA FROM A VARIETY OF OTHER
SYSTEMS AND THEY EXPECT CERTAIN
DATA ELEMENTS TO BE IN PLACE
WHICH IF THEY DON'T GET, THEY
WOULD REJECT.
SO THIS RATHER LONG MESSAGE
INCLUDES THE LIMITED NUMBER OF
FIELDS WE ASKED FOR AND ENSURING
COMPATIBILITY.
WE HAVE A NUMBER OF COMPANIES
HERE ALREADY USING RADX MARS AND
REPORTING THROUGH THAT MECHANISM
AND HAVE ANOTHER NUMBER OF
COMPANIES ONBOARDING THAT HAVE
BEEN INTRODUCED TO THE PLATFORM
OR WITH WHOM WE'RE IN
DISCUSSIONS.
TOGETHER, ALL THE COMPANIES
REPRESENT THE MAJORITY OF MARKET
SHARE OF TEST MANUFACTURERS.
>>IMPRESSIVE LIST, KRISHNA BUT
WHAT'S TAKING SO LONG TO GET THE
GROUPS ON BOARD?
>>THERE'S A COUPLE STEPS IN THE
PROCESS, ANDREW.
NUMBER ONE IS ADOPTING THE
SPECIFICATION INFORMATION THE
HR7 MESSAGE AND TWO IS
ESTABLISHING CONNECTIVITY TO THE
HUBS WE DESCRIBED AND FDA
APPROVAL.
THE FDA HAS TO APPROVE THE APPS
BEFORE THEY MAKE THEIR WAY TO
THE PUBLIC AND THAT'S ANOTHER
STEP IN THE PROCESS.
>>HOPEFULLY WE CONVINCED YOU
THAT RADX MARS ACCOMPLISHED A
LOT OF WHAT IT SET OUT TO DO TO
ESTABLISH A STANDARD FOR
CAPTURING HOME TEST RESULT
SYSTEMS AND TO DRIVE ADOPTION OF
THE STANDARD BY THE MAJORITY OF
TEST MANUFACTURERS.
BUT ONE THING THAT HAS
TRANSPIRED OVER TIME IS PEOPLE
HAVE BECOME FAMILIAR HAVE BECOME
FAMILIAR WITH THE TESTS AND
ADMINISTER AND STOPPED BY AND
LARGE INSTALLING APPS ON THEIR
PHONES FOR THE PROCESS.
IT MAKES SENSE.
IF YOU HAVE THREE TYPES OF TESTS
IN YOUR CLOSET EVERY TIME YOU
TAKE A BRAND OF TEST, ARE YOU
INSTALLING AN APP ON YOUR PHONE
OR INSTALL USER NAME AND
PASSWORD?
THAT WAS THE ONLY WAY TO REPORT
THROUGH THE APPS.
WE HEARD ON THE ORDER OF 1% OF
PEOPLE TAKING THE HOME TESTS ARE
ACTUALLY USING THE APPS.
MEANING 99% OF PEOPLE DIDN'T
HAVE THE OPPORTUNITY TO REPORT
THEIR RESULTS.
WE WERE INTERESTED IN ENABLING
LOW BARRIER MECHANISMS.
TO ORIENT YOU TO THE DIAGRAM.
WE HAVE EXISTING CHALLENGES FOR
COLLECTING COVID DATA AND LABS
AND POINTS OF CARE AND MOBILE
APPS AND WHAT WE WERE INTERESTED
IN DOING WAS SEEING WHETHER WE
COULD BUILD THE WEBSITE TO
ENABLE PEOPLE TO REPORT THE
RESULTS OF ANY TESTS WITHOUT
HAVING TO INSTALL AN APP AND IF
WE COULD ENABLE PEOPLE TO REPORT
THEIR TEST RESULT BY SIMPLY
SENDING TEXT MESSAGES.
WE WANTED TO DO THIS IN A WAY
THAT WOULD HAVE THE DATA FLOW
THROUGH EXISTING CHANNELS AND
USE EXISTING STANDARDS.
THIS LED US TO BUILD A WEBSITE
CALLED MAKE MY TEST COUNT.org.
BRUS GAVE AN INTRO TO THE SITE
EARLIER.
I'LL TWO OVER FEATURES IN MIND
IT'S INTENDED TO BE A SIMPLE
SITE AND YOU CLICK WHETHER YOU
TESTED POSITIVE OR NEGATIVE AND
WHICH BRAND OF TEST YOU TOOK AND
SPECIFY THE DATE AND REQUIRED
FIELD AND ONE MORE OPTIONAL PAGE
WHERE YOU CAN ADD DEMOGRAPHIC
INFORMATION AND THAT'S IT AND
THE TEST RESULT GETS ON ITS WAY
AND REACHES THE SAME NATIONAL
AND LOCAL HEALTH SYSTEMS AS THE
OTHER RESULTS DATA SENT THROUGH
THE MOBILE APPS.
WE WANTED TO ENSURE THE SITE WAS
USER FRIENDLY AND ACCESSIBLE ON
SMARTPHONES AND COMPUTERS
BECAUSE THE DATA CAPTURED
THROUGH MAKE MY TEST COUNT.org
ARE SENSITIVE WE WANT TO MAKE
SURE THEY'RE STORED ON DATABASES
THAT FLY -- COMPLY WITH
STANDARDS AND WE HAVE MARS
SPECIFICATIONS SO THEY'RE ALL
COMPATIBLE.
THE SITE IS SCALABLE AND CAN
HANDLE A LARGE NUMBER OF TEST
RESULT SUBMISSIONS AND FINALLY
IT'S ONE THING TO BUILD THE SITE
BUT ANOTHER THING TO SPREAD
AWARENESS AND WANT OTHERS TO
EMBED THE REPORTING
FUNCTIONALITY IN THEIR OWN
WEBSITE.
MAYBE A LOCAL PUBLIC HEALTH
DEPARTMENT HAS INTEREST IN
CAPTURING THE DATA THEY CAN
EMBED THE REPORTING
FUNCTIONALITY IN THEIR OWN
HEALTH DEPARTMENT'S WEBSITE AND
THUS INCREASE AWARENESS.
>>IS THIS ANOTHER REPOSITORY?
>>IT'S NOT IT'S A MEANS TO
CAPTURE DATA BUT THEY'RE FLOWING
THROUGH EXISTING CHANNELS AND
REACHING THE SAME REPOSITORIES
AS OTHERS.
AS BRUCE SPOKE ABOUT, IT WAS A
BIG LIFT, MAYBE A LONG LIFT TO
GET THE WHITE HOUSE TO ADD THE
BUTTON TO REPORT THE RESULTS ON
COVID.gov BUT IT'S HERE NOW AND
IT'S ANOTHER WAY TO INCREASE
AWARENESS.
ANYONE WHO COMES TO COVID.gov
CAN PUT IN THEIR ORDER FOR T%E
THREE HOME TESTS NOW SEES THE
BUTTON THAT LETS THEM KNOW HOW
THE RESULTS WILL BE REPORTED.
WE ALSO HAD A FAIR AMOUNT OF
INTEREST FROM THE MEDIA AND
THERE'S ARTICLES AND NEWS
OUTLETS THAT PICKED IT UP TO
INCREASE AWARENESS FOR THE SITE.
LET'S LOOK AT THE DATA CAPTURED
THROUGH THE SITE.
THIS IS A SNAPSHOT AS OF THIS
MORNING.
WE'RE LOOKING AT CUMULATIVE TEST
RESULTS SUBMITTED THROUGH MAKE
MY TEST COUNT.org AND WE'VE HAD
STEADY GROWTH OVER TIME AND WE
HAD OVER 41,000 INDIVIDUALS WHO
SUBMITTED THEIR TEST RESULTS TO
THE SITE.
>>ARE THEY COUNTED BY THE CDC
AND PUBLIC HEALTH REPORTING?
>>NOT YET.
IT'S A BRAND NEW TYPE OF DATA
BEING CAPTURED AND AS WE LOOK
DATA POSSIBILITIES PUBLIC HEALTH
AGENCIES WILL MAKE MORE INFORMED
DECISIONS WHETHER OR NOT TO
COUNT THE AT-HOME TEST RESULTS
IN OFFICIAL COUNTS.
MORE DATA.
ON THE LEFT WE'RE LOOKING AT THE
BREAKDOWN OF TEST RESULTS
LOOKING AT DOES MY TEST COUNT
AND THE VAST MAJORITY REPORTED
ARE POSITIVE.
78% POSITIVE AND 21% OR 22%
REPORTED THROUGH THE SITE HAVE
BEEN NEGATIVES.
THIS DOESN'T MEAN 78% OF PEOPLE
ARE TEST AT HOME.
IT'S NOT A POSITIVITY RATE BUT
IT UNVEILS HUMAN BEHAVIOR AND
PEOPLE THINK IT'S MORE IMPORTANT
TO REPORT POSITIVE OVER NEGATIVE
RESULTS.
THERE'S BIAS IN REPORT.
WE'RE TRYING TO UPDATE OUR
MESSAGING TO EDUCATE THE PUBLIC
TO REPORT NEGATIVES AS WELL AS
POSITIVES.
IF YOU RECALL WE MENTION ED
REPORTING IS OPTIONAL BUT ALMOST
EVERYONE WHO REPORTS IS SHARING
THE DEMOGRAPHIC INFORMATION.
FINALLY WE SEE A BREAK DOWN OF
SEX.
60% OF RESULTS BEING SUBMITTED
THROUGH THE SITE ARE COMING FROM
FEMALES WHEREAS ONLY ABOUT 40%
FROM MALES.
WE HAVE A LOT OF WORK LEFT AND
WE HAVE PERSONALIZED USER
EXPERIENCE AND BUILDING SUPPORT
TOOLS AND THIRD IS BUILDING UP
ADDITIONAL FEATURES THAT HELP
INCENTIVIZE THE PUBLIC TO COME
TO THE WEBSITE AND REPORT
RESULTS.
ONE THING WE'LL BE DOING IS
ADDING FUNCTIONALITY FOR PEOPLE
TO LOG IN.
THIS WILL ALLOW PEOPLE TO SUBMIT
RESULTS OVER TIME TO TRACK AND
SEE A HISTORY OF RESULTS AND
ALLOW US TO SEE WHAT RESULTS ARE
COMING FROM THE SAME PERSON OVER
TIME TO ASSIGN MULTIPLE RESULTS
TO A SINGLE INDIVIDUAL.
WE'RE TRYING TO THROUGH THE
EMBEDDING FUNCTIONAL.
WE RECEIVED WORD FROM THE FDA IT
WILL LIKELY FULFILL THING
REQUIREMENT THEY PUT ON
MANUFACTURERS SO IF THE TEST
MANUFACTURER DOESN'T WANT TO
BUILD THEIR OWN APP THEY CAN
INSTEAD LINK OUT TO MAKE MY TEST
COUNT.org AS THEIR SOLUTION FOR
REPORTING.
FINALLY ADDING TOOLS FOR THE
PUBLIC TO INCENTIVIZE A REPORT
AND ONE IS A TESTING PASSPORT.
THIS WOULD BE AN OFFICIAL
DOCUMENT THAT SHOWS SOMEONE'S
INFORMATION IN A STANDARDIZED
MANNER TO A SHARE THAT WITH A
HEALTH CARE PROVIDER OR TO GAIN
ENTRY TO A FACILITY.
WE'LL ALSO BE ADDING THE ABILITY
FOR PEOPLE TO SHARE THEIR
PERSONALLY IDENTIFIABLE
INFORMATION, NAME, ADDRESS,
PHONE NUMBER AND THIS IS
SOMETHING USEFUL TO THE STATE
AND LOCAL HEALTH CARE AGENCY.
WE'LL ADD THE ABILITY TO REPORT
BY TEXT MESSAGE AND HAVING
PEOPLE REPORT POSITIVE TEST
RESULTS THROUGH THE SITE TO GET
LINKED TO DIFFERENT WAYS TO GET
TREATMENT.
WE TALKED TO THIS POINT ABOUT
REPORTING OF COVID-19 TEST
RESULTS.
WHAT DOES ONE DO ONCE THEY
REPORT AND HOW DO THEY GET
TREATMENTS?
>>THE RADX PROGRAM SO FAR HAS
PROVIDED RESOURCES TO TAKE TESTS
AT HOME AND TEST TO TREAT IS A
CONTENT THAT ENABLES INDIVIDUALS
TO TEST FOR COVID-19 AND SEE A
HEALTH CARE PROVIDER AND RECEIVE
A PROSCRIPTION FOR AN ORAL AN
ANTIVIRAL TREATMENT.
THE HHS HAS BEEN RUNNING A TEST
TO TREAT PROGRAM FACILITY BASED
AND LET'S LOOK AT A MAP THAT
DESCRIBES THE LOCATION.
THIS IS A MAP AND THE CIRCLES
REPRESENT THE FACILITY-BASED
TEST TO TREAT PROGRAM RUN BY
HHS.
THERE'S IMPORTANT CHALLENGE.
LET'S LOOK AT HOW FAR SOMEONE
MAY NEED TO TRAVEL TO ACCESS
FACILITY.
ON THE MAP WE'RE LOOKING AT A
COLOR CODED MAP OF THE DRIVING
TIME AND DISTANCE TO GET ACCESS
TO A TEST TO TREAT FACILITY.
IN FLEW ARE LOCATIONS WHERE
SOMEONE MAY HAVE A DISTANCE LESS
THAN 30 MINUTES YOU CAN SEE
THERE'S A LARGE PART OF THE
COUNTRY NOT BLUE AND WHERE
INDIVIDUALS WOULD HAVE ROUND
TRIP TRAVEL TIMES OF OVER AN
HOUR.
ONE PROBLEM IS ACCESS.
LARGE AREAS OF THE COUNTRY ARE
WITHOUT NEARBY FACILITIES AND
THERE'S A RISK TO A SICK PERSON
LEAVING THEIR HOME AND RISK TO
THE PUBLIC WHO INTERACTS WITH
SOMEONE WHO MAY BE INFECTIOUS.
THIS IS WHERE THE HOME TEST TO
TREATMENT PROGRAM COMES IN AND
THERE WAS ONE IN THE WHITE HOUSE
FACT SHEET SEPTEMBER OF LAST
YEAR.
WE RUN IT IN PARTNERSHIP WITH
THE ADMINISTRATION FOR STRATEGY
PREPAREDNESS AND RESPONSE AT
HEALTH AND HUMAN SERVICES.
OUR IMPLEMENTATION PARTNERS AND
RESEARCH PARTNER UMASS CHAN
MEDICAL SCHOOL.
WE WANT TO PROMOTE EQUITY IN
VULNERABLE POPULATIONS AND TEST
EFFECTIVENESS AND TO PROMOTE
BEST PRACTICES IN HEALTH CARE
REPORTS MANAGEMENT.
-- RECORDS MANAGEMENT.
THIS SAY WORK FLOW MANAGEMENT
THAT SUMMARIZES THE PROGRAM WE
HAVE A TEST DISTRIBUTION
WAREHOUSE AND TELEHEALTH
PROVIDER AND ONLINE PHARMACY AND
ON THE BOTTOM IS A HEALTH CARE
PROVIDER OR COMMUNITY RESOURCE.
INDIVIDUALS IN THE PROGRAM MAY
REQUEST TESTS FROM HOME AND THEM
DELIVERED TO THEIR HOME ADDRESS
TO TAKE TESTING AND VOLUNTARILY
REPORT THROUGH THE CHANNELS
DESCRIBED EARLIER.
IF AN INDIVIDUAL TESTS POSITIVE
THEY CAN REQUEST A
TELECONSULTATION FOR A LICENSED
PROVIDER IN THEIR REGION TO
SPEAK WITH THEM AND ASSESS THEIR
ELIGIBILITY FOR TREATMENT.
IF AN INDIVIDUAL IS ELIGIBLE,
THE TELEHEALTH PROVIDER WILL
PRESCRIBE THE MEDICATION TO A
PHARMACY NEAR THE INDIVIDUAL'S
ADDRESS.
THE IDEA IS FOR THE TREATMENT TO
START WITHIN FIVE DAYS OF
SYMPTOM ONSET.
AND IN ADDITION TO THE DIGITAL
HEALTH PROGRAM HERE WE ENABLED
TELEPHONE SERVICES FOR PEOPLE
WHO NAY NOT HAVE ACCESS TO THE
TELECOMMUNICATION RESOURCES MAY
CALL AND AVAIL THEMSELVES OF
THESE SERVICES.
INDIVIDUALS NOT ELIGIBLE FOR
BEING PRESCRIBED MEDICATIONS
WILL BE REFERRED TO A COMMUNITY
RESOURCE OR PROVIDER IN
PARTNERSHIP WITH A STATE AND
LOCAL HEALTH DEPARTMENTS.
OUR EXPECTED POPULATION SIZE IS
ABOUT 120,000 INDIVIDUALS.
WE EXPECT TO SHIP ABOUT 80,000
TEST KITS AND EACH KIT CONTAINS
SIX TESTS.
WE EXPECT ABOUT 8,000 TELEVISITS
AND ABOUT OF 6,000 ORAL AND
ANTIVIRAL SHIPMENTS.
WE LAUNCHED LAST WEEK IN
PENNSYLVANIA OUR FIRST COMMUNITY
AND HAVE A GOOD AMOUNT OF
ENTHUSIASM FROM THE COMMUNITY
THE SITE SELECTION CRITERIA.
HOW DO WE CHOOSE THE SITES?
THESE ARE BASED ON SITES WITH
HIGH SOCIAL VULNERABILITY INDEX,
LOWER VACCINATION RATES AND HIGH
COMMUNITY TRANSMISSION.
WE RECEIVE D SOME PRESS AND THI
IS AN INTERVIEW FROM A LOCAL
STATION WE DID INDEPENDENTLY
LAST WEEK.
THIS BRINGS US TO THE CONCLUSION
OF THE PRESENTATION AND OUTLINED
OPPORTUNITIES AND FUTURE
DIRECTIONS.
WE TALKED ABOUT THE FUTURE OF
HOME DIAGNOSTIC REPORTING NOT
ONLY THE ABILITY OF INDIVIDUALS
TO TAKE THE TEST BUT REPORT TO
APPROPRIATE SYSTEMS.
WE'VE ENSURED THE VULNERABLE
POPULATIONS ARE RECEIVING ACCESS
TO SERVICES.
THERE'S BEEN EXCITEMENT ABOUT
ADDING ADDITIONAL PATHOGENS TO
OUR WORK FLOW.
IN ADDITION TO COVID, MULTIPLE
HEALTH DEPARTMENTS AND
COMMUNITIES HAVE SAID CAN WE
ALSO ADD FLU.
WE'RE IN ACTIVE DISCUSSIONS
ABOUT USING MULTIPLEX TESTING
THAT SIMULTANEOUSLY PERFORM
COVID AND FLU TESTING.
FINALLY EMPOWERING INDIVIDUAL TO
MANAGE THEIR HEALTH CARE DATA
WITH TESTING AT HEM -- HOME WE
WANT TO PROMOTE AND ESTABLISH
DATA AND ALLOWING INDIVIDUAL TO
SHARE DATA WITH THEIR PROVIDER
TO PROMOTE CONTINUITY OF CARE.
THAT BRINGS US TO THE END OF OUR
PRESENTATION.
THANK YOU FOR YOUR ATTENTION.
WE'RE OPEN TO QUESTIONS.
>>THANK YOU ANDREW AND KRISHNA.
WONDERFUL PRESENTATION.
KRISHNA'S BACKGROUND AS A
PROFESSOR OF RADIOLOGY AT SLOAN
KETTERING AND HEAD OF IMAGING
INFORMATICS.
HE'S A CLASSIC CONVERGENCE
SCIENCE EXAMPLE BRINGING THOSE
PRINCIPLES TO IMAGING AND
INFORMATICS INTO THIS IN VITRO
DIAGNOSTIC POINT OF CARE HUMAN
BEING PLATFORM TECHNOLOGIES.
A LOT OF CROSS FERTILIZATION
GOING ON AND FROM A BIG PICTURE
SUMMARY FOR US WE CAN SAY
MISSION ACCOMPLISHED.
IF YOU'VE STUCK WITH OUR TALKS
AND UPDATES GOING BACK TO 2020
WE SAID WE COULD MAKE A
DIFFERENCE IN TERMS OF THE
NUMBER OF TESTS AND GET THEM OUT
TO DIFFERENT SETTINGS.
SOMEHOW FIGURE WAYS TO
COMMUNICATE WHAT BEST RESULTS
ARE AND BUILD PLATFORMS TO
SUPPORT THAT AND EMPOWER
INDIVIDUALS TO BE ABLE TO MAKE
DECISIONS.
WE DIDN'T SEE TREATMENT COMING
BACK IN THOSE DAYS BUT AS SOON
AS THE PRESIDENT SAID TEST TO
TREAT IS A TOP PRIORITY OF HIS,
WE EMBRACED THAT AND I THINK OUR
WHOLE COMMUNITY HAS TO EMBRACE
THE IDEA OF DIAGNOSTICS WHICH
ARE LEADING TO PRECISION
MEDICINE WE CAN DELIVER.
SOMETHING WE ALL BELIEVE IN AND
A LOT OF THE HIGHWAYS AND
TECHNOLOGIES AND PLATFORMS NOW
THROUGH THIS EFFORT HAVE BEEN
BUILT AND IT'S UP TO ALL OF YOU
TO FIGURE OUT NEW WAYS TO
LEVERAGE IT.
I'LL STOP THERE AND WE OPEN IT
UP FOR QUESTIONS.
>>GREAT PRESENTATION GUYS.
I ENJOYED THAT.
ARE YOU TIED TO THE SHIELD
INITIATIVE AND THE SYSTEMIC
HARMONIZATION OF LAB DATA?
YOU SHOWED IT TRANSFERRING AND
IT'S OFTEN MESSY.
HAVE YOU TIED INTO THAT PROGRAM
AT ALL AND THE FINDINGS AND
THINGS THEY'RE DOING THERE.
>>THERE'S LOTS OF COMMUNITIES
AND DIAGNOSTICS AND THE FDA.
WE'VE BEEN CLOSELY TIED WITH
THAT COMMUNITY AT LARGE.
LARGELY BECAUSE OF THE STANDARDS
WORK WE'VE DONE.
THERE'S A NEED FOR A TOTAL
EFFORT OF STANDARDIZATION IN THE
TESTING AND DIAGNOSTIC SPACE.
SHIELD IS A GREAT STEP FORWARD
AND THE WORK WE'VE DONE HAS
HELPED SET UP BEST PRACTICES AT
THAT IDEA.
>>I LIKE THE TYING IN TO POINT
OF CARE IN GENERAL.
I THINK COVID -- I DON'T KNOW A
LOT OF PEOPLE ARE REPORTING
THEIR COVID RESULTS ANYMORE AND
DON'T KNOW WHY THEY NEED TO AND
MAYBE THAT NEEDS TO BE BETTER
HIGHLIGHTED FOR PEOPLE I CAN
TELL YOU MY CIRCLES OUTSIDE
HEALTH CARE I DON'T KNOW ANYBODY
REPORTING.
POINT OF CARE IS THE NEXT BIG
THINK IN HEALTH CARE AND COULD
BE KEY TO GETTING THAT
INFORMATION TO THE RIGHT PEOPLE.
THANKS, GUYS.
>>IT'S IN PART BECAUSE THERE
HASN'T BEEN A DECLARATION FROM
PUBLIC HEALTH THAT I WAS OF
VALUE.
IN FACT WE MET RESISTANCE THE
WHOLE TIME.
>>THANK YOU FOR THE WONDERFUL
PRESENTATION AND CONGRATULATIONS
AGAIN.
I LOOK FORWARD TO WORKING WITH
THE WHOLE TEAM HERE.
I HOPE HOPE WE'LL HAVE
INTERACTIONS REGARDING THE
PRESENTATION.
THANK YOU, AGAIN, KRISHNA AND I
ENJOYED THAT VERY MUCH.
WHENEVER YOU PRESENT TECHNOLOGY
BASED HOW WILL WE MAKE SURE THE
HEALTH DISPARITY COMPANIES ARE
ACCOMMODATED IN WHAT WE ARE
DOING?
FOR EXAMPLE PEOPLE HAVE TO BE
VERY MUCH AWARE OF TECHNOLOGY
ASPECT OF USING SMARTPHONES OR
GETTING TO THE INTERNET TO LOG
IN THEIR INFORMATION.
THERE ARE WAYS TO MAKE IT EASIER
FOR PEOPLE TO HAVE A WAY TO
PRESS THE BUTTON AND SEND IT TO
WHERE THEY WANT.
THERE'S A BIG ISSUE WE ALL FACE
TODAY.
AND I DON'T SEE THE ADVANTAGE OF
ANYBODY THAT'S AN HOURLY WORKER
TO REPORT THEY HAVE COVID.
THEY KNOW IF THEY'RE NOT GOING
TO BE PAID THEY DON'T TELL WORK
AND HAVE CONTRASTING DRIVERS
THAT MAKE PEOPLE RESPOND TO OR
NOT RESPOND TO TECHNOLOGY AS WE
SEE IT TODAY.
THE LAST POINT IS THE COMPLIANCE
ISSUE.
WE'VE COME UP WITH A LOT OF
TECHNOLOGIES AND YOU CAN THINK
OF DOWN THE LINE OF THE RFAs.
HOW TO ADDRESS WHEN PEOPLE DO
WHAT YOU EXPECT THEM TO DO.
RIGHT NOW WE CAN TAKE A NEXT
STEP FROM TECHNOLOGY APPLICATION
TO ENSURE COMPLIANCE.
SO MANY QUESTIONS.
EXCITING TIMES.
THANK YOU SO MUCH.
>>BEFORE I TURN IT OVER TO
ANDREW AND KRISHNA, THOSE ARE
EXACTLY THE QUESTIONS WE'VE BEEN
DISCUSSING INTENSIVELY AND WE
HAVE ANSWERS FOR YOU.
YOU GUYS SHOULD JUMP IN.
>>THOSE ARE GREAT QUESTIONS.
WE'RE IN THE TECHNOLOGY DIVIDE.
WE WANT TO ENABLE METHODS FOR
PEOPLE TO REPORT AND PARTICIPATE
IN THESE TREATMENT PROGRAMS
WITHOUT A LAPTOP OR SMARTPHONE
AND PEOPLE CAN THE SAME
PARTICIPATION AND RECEIVE THE
SAME ACCESS WITHOUT A CONNECTION
TO THE INTERNET.
THE NEXT POINT WAS AROUND
COMPLIANCE AND DISINCENTIVES FOR
PEOPLE TO REPORT.
I WOULD SAY THERE THAT WE'RE
NEVER GOING TO GET TO A PLACE
WHERE EVERYONE'S TAKE TEST AT
HOME AND REPORTING.
WE'RE RELYING ON INDIVIDUALS WHO
CHOOSE TO REPORT AND TEST.
PEOPLE WON'T TEST BECAUSE THEY
DON'T WANT TO KNOW BECAUSE IT
MAY PREVENT THEM FROM GOING TO
WORK.
I'M NOT SURE WE'LL SOLVE THE
CHALLENGES BUT WE'RE ENABLING
PATHWAYS FOR PEOPLE WILLING TO
DO SO TO REPORT THEIR TEST
RESULTS.
WE'RE NEVER GOING TO HAVE
COMPREHENSIVE DATA IN COVID
TESTING IN THE HOME SETTING.
WE'LL NEVER BE ABLE TO LOOK AT
THE DATA AND SAY THIS IS A
POSITIVITY RATE BECAUSE THIS IS
HOW MANY POSITIVES WE HAVE AND
HOW MANY NEGATIVES WE HAVE.
WE'LL HAVE TO LOOK AT TRENDS IN
THE DATA AND HOW IT CHANGES OVER
TIME.
AND I LEARNED THERE'S A PROBLEM
OR CHALLENGE GOING ON FOR DE
DECADES IN THE CASE OF FOOD
REPORTING THERE'S -- FLU
REPORTING AND THERE'S A
HESITANCY SO THE REPORTING ISN'T
A TRUE PICTURE OF THE LEVELS OF
FLU ACROSS THE COUNTRY.
THOSE ARE SOME OF MY THOUGHTS.
I DON'T KNOW IF YOU WAND TO
ADDRESS -- WANT TO ADDRESS THAT
AT ALL.
>>I WAS GOING TO EXPAND ON THE
TOPIC.
2.5 BILLION TESTS HAVE BEEN
PRODUCED FOR HOME TESTING IN
2022.
THAT'S A STATISTIC.
AS HEALTH CARE DELIVERY SHIFTS
AND WE MOVE TO THE NEW WORLD OF
HOME DIAGNOSTICS, WE AS A
SCIENTIFIC COMMUNITY HAVE TO
START ADAPTING TO NEW WAYS OF
THINKING ABOUT THE DATA.
IT MAY NOT JUST BE THE ABSOLUTE
NUMBERS.
WE NEED TO FOCUS ON TRENDS AND
SEE HOW IT LEADS TO INFORMATION
ON WHAT'S HAPPENING.
THIS TRANSITION TO HEALTH CARE
IS HAPPENING.
WE'RE THE ONES THAT NEED TO
ADAPT TO IT.
>>A BIG PICTURE ANSWER TO THE
QUESTION IS ABOUT CHANGING
CULTURE.
WHEN WE STARTED I WAS ABLE TO
PARTNER WITH AGENCIES I NEVER
HEARD OF BEFORE, AFSA AND CMS,
WHITE HOUSE, CDC, FDA.
AND I WOULD SAY TO AN AGENCY
THEY THOUGHT WE WERE SLIGHTLY
CRAZY BUT INTERESTING FOR THE
IDEAS WE WERE ADVOCATING FOR AND
PEOPLE COULD TEST AT THEIR HOMES
AND WE COULD INTRODUCE A VARIETY
OF MECHANISMS AND MAKE THE
SYSTEM WORK.
FOR THE MOST PART FOR WELL OVER
A YEAR I THINK WE MET ENORMOUS
RESISTANCE THAT'S GRADUALLY
DISSIPATED.
BECOME MORE SYMPATHETIC AND IT'S
CHANGED THE PERCEPTION OF
TECHNOLOGIES AND HOW OUR
COMMUNITY CAN THAT WAY OF
THINKING INTO PUBLIC HEALTH AND
INTO THESE DIVERSE ACTIVITIES OF
ALL THESE AGENCIES.
I KNOW THAT'S A HIGH LEVEL WAVY
ANSWER BUT IT MEANS THINGS CAN
CHANGE AND WE CAN CONTRIBUTE IN
A POWERFUL WAY.
I ENCOURAGE ALL OF YOU TO DIVE
IN AND THEN THESE STRUCTURES
CREATED, RADX MARS IS EXPORTABLE
TO ANY HOME TEST.
ANYTHING YOU'RE WORKING ON OR
DEVELOPING IT CAN GROW AND
EXPAND AND MOVE INTO THESE
AREAS.
>>JOYCE.
>>KRISHNA AND ANDREW THANK YOU
VERY MUCH.
KUDOS TO YOU I'M ALREADY
THINKING HOW TO INCORPORATE THE
CASE MODEL AND I'M TEACHING THIS
YEAR ON DIAGNOSTIC DESIGN AT
BOSTON MASS AND I LOVE THE
DELIVERY OF HEALTH CARE, SO
THANK YOU SO MUCH.
ANY QUESTION HAS TO DO ABOUT
ENGAGING STAKEHOLDERS AND IN
PARTICULAR THINKING ABOUT MY
COLLEAGUES HERE IN THE SCHOOL OF
PUBLIC HEALTH PARTICULARLY
COMMUNITY HEALTH.
I'M WONDERING, EVERYTHING YOU'VE
SHOWN IS IN ENGLISH.
I'M WONDERING IF YOU THOUGHT
SIMILAR TO WHAT SAM WAS SAYING
THE TECHNOLOGY DIVIDE AND
WONDERING WHAT YOU'RE DOING
ABOUT OTHER LANGUAGES.
WE UNDERSTAND WHAT IT TAKES TO
WORK WITH COMMUNITYIES SO CURIOS
ABOUT YOUR THOUGHTS ON THAT.
>>IT'S AN IMPORTANT QUESTION.
WHAT'S OUR GOAL?
TO EMPOWER INDIVIDUALS.
IN ORDER TO DO THAT YOU HAVE TO
COMMUNICATE.
IF YOU DON'T HAVE IF YOU'RE
RELEASING TECHNOLOGY AND SOMEONE
CAN READ THE INSTRUCTIONS, YOU
HAVEN'T ACHIEVED YOUR PURPOSE.
WE'VE LOOKED AT ACCESSIBILITY.
JOE HAD A SLIDE.
WE HAD A STRONG EMPHASIS ON
ENSURING WE'RE TRYING TO REACH
THE BROADEST POPULATIONS
POSSIBLE.
IN THE SAY YES COVID PROGRAM
THERE WAS A STRONG EMPHASIS IN
WORKING WITH A LOCAL PUBLIC
HEALTH DEPARTMENT.
UNDERSTAND WHO WILL IS THIS
POPULATION WE'RE DELIVERING
TESTS TO.
SOMETIMES IT WAS SPANISH AND
OATH LANGUAGES.
THE TEST THEMSELVES IN THE EARLY
DAYS IF YOU LOOKED AT SOME
MANUFACTURERS, THE TESTS WORKED.
THE VITAL FLOW ASSAY WORKED AND
THEY'RE GOOD BUT OUR OBSERVATION
WAS IT'S HARD TO OPEN THE
PACKAGING.
IF SOMEONE CAN'T OPEN THE
PACKAGE YOU HAVE A PROBLEM.
IT GOES NOT ONLY TO LANGUAGES
BUT LOOKING AT UNDER SERVED,
DISABLED, DEXTERITY, THERE'S A
LOT OF THINGS THAT HAVE TO BE
CONSIDERED TO MAKE EFFECTIVE
SOLUTIONS.
>>SUSAN.
>>IT SOUNDS LIKE THERE'S AN
EMPHASIS ON ASSESSING TRENDS
RATHER THAN PRECISION IN TERMS
OF THE CASES AND IN THE CASES OF
DOUBLE COUNTING YOU DIDN'T
MENTION THAT THERE'S A
POSSIBILITY OF INCLUDING
REPORTERS AS BEING SCHOOLS
EMPLOYERS AND AN EMPLOYER MAY
HAVE REPORTED POSITIVE BUT A
HIGHER CHANCE AN EMPLOYER MAY BE
SOMEONE IS NOT REPORTING FOR
WORK AND BE A SOURCE OF REPORTS
AND WONDERING IF YOU'RE
CONSIDERING THAT THE DOUBLE
COUNTING AND BROADENING BEYOND
INDIVIDUALS.
>>IT'S IMPORTANT WE MAKE A
DISTINCTION BETWEEN THE DATA
WE'RE CAPTURING AND POINT OF
CARE PATHWAYS.
ANYTHING AT A NURSING HOME FOR
SCHOOL SETTING THERE'S OTHER
SYSTEMS THAT USE SIMILAR
STANDARDS TO CAPTURE THAT DATA
AND HAVE THEM REPORTABLE.
PUBLIC HEALTH DIEPARTMENTS ARE N
AGREEMENT THEY'LL TAKE THE DATA
AND HAVE INTERESTING.
IT'S TRUE SOMEONE MAY GET TESTED
AT THEIR SCHOOL OR EMPLOYER THAT
RESULT WOULD GET REPORTED AS A
POINT-OF-CARE RESULT AND THE
SAME RESULT MAY BE THE
INDIVIDUAL SAYS I HEARD ABOUT
THIS MAKE MY TEST COUNT WEBSITE
AND I'LL REPORT THERE AS WELL.
WE HAVE A WAY FOR OUR STANDARDS
TO CAPTURE INFORMATION ABOUT
WHETHER IT'S THE SAME INDIVIDUAL
TESTED MULTIPLE TIMES OVER TIME
IF SOMEONE IS USING A MOBILE
PHONE APP WE CAN SEE THE SAME
INDIVIDUAL BUT NOT THE SAME
INDIVIDUAL AS THE PERSON WHO
JUST TESTED AT THE SCHOOL THAT'S
ALSO REPORTED THE SAME RESULT
AND THAT'S WHAT WE'RE GETTING AT
WHEN WE SAY THE DATA ARE
INHERENTLY NOISIER AND MESSIER.
WITH 2.5 MILLION TESTS FLOODED
IN THE MARK WE HAVE TO ADAPT AND
DEAL WITH THE NOISINESS AND
UNDERSTAND WHAT SIGNAL LIES IN
THERE.
THAT ALSO APPLIES IN TRENDS AND
ABSOLUTES.
AND WE'RE ONLY AT 1% OF THAT
NOW.
FOR THAT REASON WE THINK AT
LEAST IN THE NEAR FUTURE TRENDS
ARE GOING TO BE THE WAY TO GO.
>>THANK YOU, ANDREW.
THE ARGUMENT THE DATA IS
UNRELIABLE IS SOMETHING WE CAN
DISCUSS AND FOR PUBLIC HEALTH WE
USED AN ARGUMENT TO STOP US AND
JUST SAY WE DON'T EVER WANT TO
SEE ANY OF THAT DATA.
SO GRADUALLY OVER TIME THERE'S
BEEN A TRANSFORMATION AND
THEY'RE NOW WILLING TO ACCEPT
THE COUNTER ARGUMENTS HOWEVER,
YOU LOOK AT IT THE LABORATORY IS
A SPARSE SAMPLING OF THE OVER
ALL POPULATION DOING TESTING AND
WE NEED VISIBILITY INTO THAT.
>>I WANT TO CONGRATULATE YOU
AND YOU CONTINUE TO THINK IN THE
FUTURE AND DELIVER.
AS I COUNCIL MEMBER I COULDN'T
BE MORE DELIGHTED TO SEE WE SAY
THINGS AT THE MEETINGS AND IT'S
BEEN IMPLEMENTED.
IT'S FANTASTIC.
WITH REGARD TO ACCESSIBILITY IN
MAKING DEVICES AND THEN I THINK
SOMEONE MENTIONED POINT OF CARE
IS THE NEXT BIG THING.
WHEN I'M LISTENING TO ALL OF
THIS THAT KRISHNA AND ANDREW
PRESENTED THE DATA ASPECTS
UNIVERSAL DESIGN CONSIDERATIONS
AND ALL YOU'RE THINKING ABOUT
AND MAKING SURE UNDER SERVED
COMMUNITIES ARE BEING SUPPORTED,
I'M THINKING ABOUT HOW MIGHT
NIBIB ONCE AGAIN UTILIZE THEIR
ABILITY IN THE CAUSE THEY'RE
PLACING FOR THE COMMUNITIES TO
COME UP WITH RESPONSES TO MAKING
DEVICES AND TECHNOLOGIES.
HOW DO WE BRING THIS TOGETHER
EVERY TIME IN EVERY PATH RATHER
THAN INDIVIDUALLY SOMETIMES OR
THIS SAY CALL FOR PERSONS WITH
DISABILITIES OR A CALL FOR CARE
DATA.
SEEING HOW WE MAY BRING THESE
ELEMENTS TO SOME EXTENT OR
ANOTHER ALL ALONG INCLUDING IN
DOING RESEARCH IN THE LABS
ITSELF.
WOULD WE WANT MORE PERSONS WITH
DISABILITIES OR PERSONS WHATEVER
SITUATIONS MAY BE PARTICIPATING
IN THE ENTIRE RESEARCH
ENTERPRISE ITSELF?
SO IT'S FANTASTIC TO SEE ALL THE
THINGS GOING FORWARD.
I THINK WE CAN BE ASPIRATIONAL
AND REACH FURTHER UP AND ANOTHER
CHALLENGE TO TRY TO TIE THEM
TOGETHER.
ABSOLUTELY FANTASTIC.
SO GLAD TO SEE THIS.
AND MANU, YOU'RE CROSSING OVER
TO THE DARK SIDE,
CONGRATULATIONS.
>>WE CAN SPEAK DIRECTLY IN OUR
RADTECH 3 FUNNEL AND HOPEFULLY
BE ABLE TO BUILD.
THAT'S AN IMPORTANT GUIDING
PRINCIPLE, MANU.
DO YOU WANT TO SPEAK TO THE
TUNNEL?
>>IT WASN'T AN EXPLICIT
REQUIREMENT IN THE CALL FOR
PROPOSALS.
WHAT WAS INTERESTING TO SEE IS
COMPANIES MADE A GOOD FAITH
EFFORT TO BUILD IN DESIGN
CONSIDERATIONS AROUND
ACCESSIBILITY BUT THEY MISSED
THE MARK OFTEN.
THAT'S OKAY BECAUSE WE HAVE THIS
INFRASTRUCTURE NOW THAT CAN HELP
THEM COURSE CORRECT AND ADOPT
ALL THE THINGS WE'VE LEARNED
OVER THE PAST 10 MONTHS.
THIS IS WHY I THINK IT'S SO
IMPORTANT THAT WE HAVE THESE
BEST PRACTICES OUT THERE
PUBLICLY NOW SO EVERYBODY WE CAN
REFER TO THEM AND PEOPLE CAN GO
THERE AND UNDERSTAND WHAT IT
MEANS.
WE COULD NOT HAVE DONE THIS
WITHOUT THE INTENSE
PARTICIPATION OF PEOPLE WHO ARE
LIVING HAVE LIFE EXPERIENCE AND
WE HAVE DESIGNERS WHO PUT ON
GLASSES WHEN THEY EVALUATE TESTS
FOR BLIND PEOPLE BUT IT'S NOT
THE SAME AS BEING BLIND.
THERE'S TOOLS THAT CAN GET
AROUND CERTAIN OBSTACLES AND
IT'S IMPORTANT THE WHOLE RANGE
OF USERS IS INVOLVED IN THE
ENGINEERING AND DESIGN OF THE
PRODUCTS THAT COME TO THE
MARKET.
>>DAN AND THEN ANNE.
>>FIRST I WANT TO ECHO OTHER
PEOPLE'S APPRECIATION FOR YOUR
VISION AND THE PROGRESS YOU
REPORTED BUT ALSO FOR THIS
INITIATIVE.
I THINK IT'S GREAT AND IMPORTANT
WORK.
BOTH YOU AND BRUCE TALKED ABOUT
THE GENERALIZABILITY FOR THE
TOOLS FOR POINT OF CARE TESTS
AND SO ON.
IT'S GETTING AHEAD OF THE GAME
NOW MAYBE BUT I'M WONDERING IF
YOU'VE GIVEN ANY THOUGHT TO WHAT
MIGHT BE REQUIRED FOR MORE
CONTINUOUS MONITORING OPPOSED TO
EPISODIC TESTS LIKE A COVID TEST
YOU TAKE ON DEMAND BECAUSE
PUNDITS PREDICT WE'RE HEADING
TOWARDS A FUTURE OF CONTINUOUS
CARE AND WOULD BE INTERESTING TO
START PREPARING FOR THAT NOW, I
THINK.
>>THANKS, DAN.
I'LL START OFF, I THINK EVERYONE
AT NIBIB WILL HAVE SOMETHING TO
SAY ABOUT THAT.
THAT'S OUR ACTUALLY WHERE WE
STARTED ALL OF THIS.
I THINK I SPENT MOST OF 2019
BARN STAORMING AROUND THE COUNTY
SAYING WE NEED TO MEASURE
BAILING ON THE TIME SCALE OF
BIOLOGY AND WE DON'T NEED
INTERVAL DIAGNOSTIC TIMES.
TIME IS THE DIMENSION WE'VE
IGNORED AND DON'T HAVE ADEQUATE
WAYS.
ZANE AND I HAD MANY
CONVERSATIONS HOW TO DO THIS AND
GET FDA INVOLVED.
THAT'S WHAT BUILT STRONG
RELATIONSHIPS WIN FDA AND DEAL
WITH IN VITRO DIAGNOSTICS WHEN
COVID CAME.
WE HAVEN'T ABANDONED CONTINUOUS
AND KEEP YOUR EYES OPEN FOR THE
RADX PROCESS AS WE PARTNER WITH
OTHER INSTITUTES.
VIRTUALLY ALL INSTITUTES HAVE
EXPRESSED SIGNIFICANT INTEREST.
YOU CAN IMAGINE DEPENDING ON
WHAT YOU'RE INSTITUTE IS, YOU
MAY WANT A CONTINUOUS CENSOR FOR
SOMETHING.
THAT'S ABOUT ALL I CAN REVEAL AT
THIS POINT.
WE HAVE SEVERAL THINGS IN THE
WORKS.
WE'RE JUST LIKE ALL OF YOU,
WE'RE THE TECHNOLOGY PEOPLE SO
WE DON'T HAVE ALL THE MONEY.
IT GOES TO THE APPLICATION
ORIENTED PEOPLE.
WE'RE TRYING TO PARTNER WITH
THEM AS BEST POSSIBLE LIKE THE
ACADEMIC COMMUNITY DOES TO
ADVANCE AND TAKE ADVANTAGE OF
WHAT WE BUILT.
>>I'M WONDERING WHETHER THIS
GETS PART WAY THERE OR A
DIFFERENT INFRASTRUCTURE YOU
GUYS THINK WOULD BE REQUIRED.
>>I THINK ALL WE HAVE TO DO IS
IF WE CAN GET TO THE POINT OF
GETTING TO AGREEMENT ON WHAT THE
DATA ELEMENTS ARE THAT ARE OF
VALUE IN CLINICAL DECISION
MAKING, THEN KRISHNA AND ANDREW,
YOU GUYS BLASTED THROUGH THAT.
YOU ACCELERATED AND GOT ONC
INVOLVED IN THE BALLOTING.
.
IT WAS FANTASTIC.
WE HAVE CREDIBILITY ON THE
STREET OR HIGHWAY OR WHATEVER IT
IS TO BE ABLE TO DO THAT.
AND TRANSFER THE ATTRIBUTES TO
OTHER TECHNOLOGIES.
ANNE.
>>THIS IS AN INCREDIBLE PROGRAM
AND SO IMPRESSIVE.
ANDREW AND KRISHNA I LOVED YOUR
PREPARATION.
THE BACK AND FORTH IS REALLY
GOOD.
I'M CURIOUS.
ONE HAS TO BE SENSITIVE TO THE
IDEA OF WHO WANTS DATA
UNRELIABLE OR IS THIS DATA
UNRELIABLE OR ARE THEY
UNRELIABLE.
I'M WONDERING IF YOU HAVE
ANYTHING IN THE HOPPER AND
THERE'S FIRE POWER BEHIND THE
PROGRAM INTELLECTUALLY AND
WONDER IF THERE'S THOUGHTS OF
WAYS OF NORMALIZING OR
CORRECTING FOR OR OTHERWISE
EVALUATING THE UNCERTAINTY IN
THE DATA OR HOW TO MINIMIZE THE
UNCERTAINTY IN THE DATA.
>>I WOULD SAY THIS IS STILL AN
EVOLVING AREA.
LET ME TELL YOU SOME WAYS WE
LOOKED AT HOW TO NORMALIZE.
THERE WAS A PUBLICATION IN THE
CDC RECENTLY THAT LOOKED AT HOME
TEST RESULTS AND POSITIVITY
NUMBERS COMPARED TO THE NUMBERS
OF LABORATORIES POINT OF CARE
OUTSIDE OF RADX AND WE SAW THE
TRENDS IN REPORTING OF THE
LABORATORY POINT OF CARE IS THEY
FOLLOWED SIMILAR TREND LINES TO
WHAT WE WERE OBSERVING IN THE
HOME TEST REPORTING SPACE.
ALREADY WE HAD SOMETHING THAT
SAID WE'RE ON TO SOMETHING.
WHEN WE SEE AN UPTICK IT WILL
CORRELATE AND THOSE CONNECTIONS
ARE WHAT WE HAVE TO KEEP WORKING
FOR.
IT'S NOISY DATA BUT THERE'S
SIGNAL THERE AND WE NEED TO FIND
IT.
>>IF I COULD SAY ADDING TO
THAT, WE ARE IN AN ERA OF
TRANSITION.
WE'RE ADAPTING CUTTING EDGE
TELECOMMUNICATIONS TECHNOLOGIES
TO LARGELY 40, 50-YEAR-OLD
ASSAYS AND IN THE RADX TECH 3
FUNNEL WE HAVE AN ENORMOUS
NUMBER OF AMAZING APPLICATIONS
WHERE THEY WILL NOT REQUIRE
SERIAL TEST IING THEY'LL BE
IMMEDIATELY CONNECTED TO A
COMMUNICATION DEVICE AS YOU KNOW
CAN BE EMBEDDED TO TAKE
ADVANTAGE AND EMBEDDED AND
TRANSFER AUTOMATICALLY WITHOUT
THE USER LOOKING AT A LINE AND
GOING TO THE INTERNET AND
PROGRESSION IN THE HARDWARE SIDE
IS CHANGING DRAMATICALLY.
HOWEVER YOU CUT IT, THE TESTS
ARE SENSITIVE TO THE INDIVIDUALS
DOING THEM AND THE INDIVIDUAL
VISUALIZING THEM.
THE TECHNOLOGY IS THERE TO MAKE
IT WAY BETTER.
>>THAT WILL BE VERY EXCITING.
THANKS.
>>ZANE.
>>I TOSSED MY HAND UP AGAIN.
A COUPLE THINGS ON THIS BECAUSE
IT'S BEEN AN INTERESTING
DISCUSSION.
ONE THING A COUNCIL, IS THERE A
POSSIBILITY HERE OF PUTTING THE
OTHER ROAD MAP WHAT THE ISSUES
ARE WITH THIS POINT OF CARE
DIAGNOSTICS NOT JUST NOW BUT IN
THE FUTURE TOO.
WE HIT ON THIS IS MOVING TO
MULTIPLE TESTS NOT JUST A COVID
TEST.
I DON'T THINK IT'S UNDERSTAND
WHAT YOU NEED THAT FROM THE DATA
TRANSFER TO THE HOSPITAL AND
THERE'S HUGE GAPS.
WE TALK ABOUT POINT OF CARE AND
WEARABLES AND FDA CONCERNS ON
THIS.
WE GOT CONCERNS ACROSS THE
BOARD.
MAYBE THERE'S AN OPPORTUNITY
HERE FOR SOMETHING LARGER AND
PUTTING TOGETHER A ROAD MAP IN
REGARD TO THIS SPACE.
>>I LOVE IT BUT BE CAREFUL ROY
VOL UN -- WHAT YOU VOLUNTEER
FOR.
I DID AND I GOT IN TROUBLE AND
WHAT I WAS CONVINCED TO DO.
IT'S A WONDERFUL IDEA AND WE
SHOULD HAVE MORE DISCUSSIONS
CONTINUING ALONG THOSE LINES,
THANK YOU, ZANE.
>>THIS DATA WILL BE OF INTEREST
TO SOME MAJOR HEALTH CARE
PROVIDERS AS WELL AS THOSE IN
THE CLINICS.
ONE IS OPENING CLINICS IN
MULTIPLE CITIES AND GOING TO
MANY COMMUNITIES.
IF YOU HAVE WAL-MART CARDS THE
DATA WOULD BE OF INTEREST TO
THEM EXTENSIVELY AND MANY HAVE
BECOME DATA COMPANIES MORE THAN
ANYTHING ELSE.
WHAT ARE WE DOING ABOUT OR
THINKING ABOUT AND HOW WILL THE
DATA BE SHARED WITH THE OTHER
PRO-PROFIT ENTITIES BECAUSE IT
MAY HELP IN SOME CASES IN
GETTING ACCESS TO REMOTE PLACES
WE CAN'T NECESSARILY TAKE FROM
NIHs POINT OF CARE AND REACH
DEPTHS.
IS THERE THOUGHT PROCESS OF
TYING SOME OF WHAT WE DO INTO
THE BIGGER AT-SCALE ENTITIES
THAT CAN DEMOCRATIZE THE
TECHNOLOGIES TO PLACES THAT MAY
HAVE NO BROADBAND ACCESS OR
WHATEVER ELSE THE PROBLEM WILL
BE SO KEEPING THAT IN MIND AND
FINANCIAL PLATFORMS TO LINK THE
SMALL START-UP COMPANY TO AN
INSTITUTIONAL BUYER.
AND WE'LL COME TO THE CONCEPT
CLEARANCE IN A LITTLE WHILE.
WE'LL HAVE TO START TO THINK
ABOUT THE OTHER ISSUES AS WE'RE
SUPPORTING TECHNOLOGY
DEVELOPMENT.
>>YEAH, IMPORTANT POINTS, RANU.
THERE'S ALSO AN ARGUMENT TO BE
MADE IT COULD BE VALUABLE TO
RELEASE THESE TYPES OF DATA TO
THE RESEARCH COMMUNITY TO SEE
WHAT ADDITIONAL INSIGHTS CAN BE
GARNERED FROM THEM.
WE'VE HAD AN INTEREST FOR A
WHILE IN DOING THIS.
WE DON'T OWN THE DATA AT NIH.
WE'RE ENABLING THE DATA TO FLOW
TO THE PUBLIC HEALTH SYSTEMS.
WE'VE BEEN WORKING WITH
CONSIDERACDC
PLANNING TO RELEASE SOME AS A
PUBLIC DATA SET WHICH SHOULDN'T
COME AS A SURPRISE.
HOW MANY TIMES HAVE WE ALL GONE
TO GOOGLE AND LOOKED UP COVID
TRENDS WHERE WE LIVE AND IT'S
BASED OFF LAB AND POINT OF CARE
DATA AVAILABLE SINCE THE START
OF THE PANDEMIC.
REASONABLE TO SUGGEST WHY CAN'T
WE DO THE SAME WITH THE AT-HOME
TESTING DATA.
IN THE COMING MONTHS WE'LL SEE A
DATA SET FROM CDC AND THAT WILL
BE A GOOD START.
IT'S OUR IMPERATIVE TO MAKE THEM
USEFUL NOT ONLY FOR PUBLIC
HEALTH SYSTEMS BUT FOR CLINICS
AND RESEARCHERS.
>>THANK YOU.
>>WE'RE BALANCING THE NEED AND
FOR REVENUE GENERATION AND
MARKETS.
THE COMPANIES DON'T ACTUALLY
EVER COME OUT.
WE DON'T SEE THEM.
OF COURSE THEY WANT TO OWN THE
DATA AS WELL BECAUSE THE DATA IS
CONVERTIBLE TO MORE CURRENCY.
AT THE SAME TIME WE SEE WITH THE
NEED FOR PUBLIC INFORMATION,
URGENT DATA WE NEED TO GET OUR
HANDS ON IN A PUBLIC HEALTH
EMERGENCY LIKE THIS, WE HAVE TO
BALANCE BOTH OF THOSE.
I DON'T THINK WE HAVE ANY SET
ANSWERS.
THE IMAGING COMMUNITY HAS KIND
OF DONE IT BACK AND FORTH BUT
STILL STRUGGLING TO GET SHARING
OF DATA.
WE NEED EVERYONE TO COME
TOGETHER AND THINK THROUGH THIS.
LOOK AT OUR USE CASES AND APPLY
SOME CLEVER APPROACHES.
WE'RE IN THE EARLY DAYS HERE
WITH THE IN VITRO DIAGNOSTICS.
CYNTHIA.
I SEE YOUR HAND.
AND MAYBE CYNTHIA, YOU'LL BE THE
LAST QUESTION AND WE'LL THEN
MOVE ON TO THE OTHERS.
IT'S BEEN AN AMAZING DISCUSSION.
THANK YOU.
>>I WANT TO COMPLIMENT YOU ON
THE WORK DONE HERE.
IT'S REMARKABLE.
ONE OF THE OTHER DATA USE CASES
I'M WONDERING ABOUT IF YOU'VE
GIVEN THOUGHT TO IS POST-MARKET
QUALITY MONITORING OF THE TESTS.
BECAUSE I WOULD ASSUME THAT THE
POSITIVITY RATE IN THE COMMUNITY
IS SOME NUMBER THAT NO MATTER
WHICH TEST YOU USE YOU WOULD
OBTAIN IN GENERAL AND ASSUME
THAT YOUR WILLINGNESS TO REPORT
WOULD BE INDEPENDENT OF WHOSE
TEST YOU BOUGHT BUT IF YOU COULD
SORT THIS OUT BY TEST
MANUFACTURER AND SAW OUTLIER
DATA THAT MAY INDICATE SOMETHING
ABOUT THE PERFORMANCE OF CERTAIN
TESTS.
>>ABSOLUTELY.
WE'VE ALREADY DONE THAT AND IT'S
AN INCREDIBLE SUGGESTION,
CYNTHIA, WE'VE DONE IT.
IN OUR 7,000 STUDY THAT
EVALUATED THREE PLATFORMS
POST-MARKET CLEARANCE FOR THEIR
CONTINUING PERFORMANCE IT USED
THE BASIC DIGITAL HEALTH
INFRASTRUCTURE BY CARE EVOLUTION
TO REPORT HOW TESTS ARE PERFORM
AND THE DIGITAL PLATFORM
DISTRIBUTION OF TECHNOLOGY SO
PEOPLE CAN VIA ONLINE SIGN UPS,
GET INTO AND GET CONSENTED FOR
ALL THE STUDIES.
THAT DATA PROVIDED ESSENTIAL
INFORMATION THAT CHANGED THE WAY
THE FDA MADE DECISIONS ABOUT
AUTHORIZATIONS.
I WON'T GO IN ALL THE DETAILS
BECAUSE IT'S QUITE A STORY.
THAT WAS A GAME CHANGER FOR
RAPID HOME TESTS AND CHANGING
THE BAR IN COMMUNICATING THEIR
PERFORMANCE.
ABSOLUTELY.
A WONDERFUL EXAMPLE OF THAT.
>>WE'LL TRANSITION AND THANK
ANDREW AND KRISHNA AND ALL OF
YOU FOR YOUR WONDERFUL COMMENTS.
ZANE, IT SOUNDS LIKE YOU
VOLUNTEERED TO LEAD OUR
SUBCOMMITTEE.
DAVID, BACK TO YOU.
DO YOU WANT TO TAKE THE LEAD FOR
THE NEXT PHASE.
>>WE HAVE TWO CONCEPT
CLEARANCES ONE BY ALBERT AVILA
AND WE WELCOMED DR. PETTIGREW.
WELCOME.
THANK YOU.
>>THANK YOU.
GOOD AFTERNOON TO THE COUNCIL.
MY FIRST ADVISORY MEETING TO
NIBIB.
I'M EXCITED TO BE HERE AND WANT
TO ALSO THANKS MY NIBIB
COLLEAGUES AND IT'S A PLEASURE
TO PRESENT THIS CONCEPT.
ON HISTORICALLY BLACK COLLEGE
UNIVERSITIES AND EXTRAMURAL
BIOMEDICAL ENGINEERING AND
TECHNOLOGY ACCELERATION eBEBETA
INITIATIVE AND HOW THIS COULD
INTERFACE WITH THAT.
CONCEPT IN GENERAL IS ABOUT
TAKING THE INITIAL STEPS NEEDED
TO SUPPORT AND PROVIDE RESOURCES
TO HBCUs SO THEY'RE EQUIPPED TO
FULLY PARTICIPATE AND CONTRIBUTE
IN THE RAPIDLY GROWING AND
EVOLVING BIOMEDICAL ENGINEERING
AND TECHNOLOGY SPACE.
SOME OF WHICH WE JUST HEARD
ABOUT PREENTLY TODAY.
BEFORE I DO, I WANT TO MENTION A
FEW THINGS.
SO MUCH OF THE GROUND WORK FOR
THE INITIATIVE WAS LAID BY THE
NIBIB COMMUNITY.
THE NIBIB COUNCIL AND WORKING
GROUP.
WE WANT TO THANK THEM AND THE
COUNCIL IN GENERAL FOR ALL THEIR
CONTRIBUTIONS AND FEEDBACK WHICH
HELPED US AS WE DEVELOPED THE
CONCEPT.
AND THE NIBIB INTERNAL WORKING
GROUP AND OTHER COLLEAGUES
CONTRIBUTED AND THANK YOU TO
EVERYBODY OUT THERE.
WE WANTED TO SHARING BACKGROUND
ON THE PROGRAM AND SINCE NIBIB
WAS ESTABLISHED IN 2000 THERE'S
BEEN A RAPID GROWTH IN UNDERGRAD
BIO ENGINEERING AND BIOMEDICAL
ENGINEERING AND TECHNOLOGY
PROGRAMS.
WE'RE AWARE THE WHITAKER
FOUNDATION PLAYED A ROLE IN THE
COMMUNITY AND LARGELY HAD A ROLE
IN THE CREATION OF NIBIB.
175 PLUS ACCREDITED
UNDERGRADUATE PROGRAMS EXIST AT
150 INSTITUTIONS.
HOWEVER, ONLY THREE OF THOSE ARE
AT HBCUs.
THE UNIVERSITY OF DIRECT OF
COLUMBIA, FLORIDA A&M AND
THERE'S OPPORTUNITIES FOR HBCUs
AND WE HOPEFULLY CAN PARTNER TO
PLAY A ROLE IN PROVIDING THOSE
RESOURCES.
THE GOAL IS TO MEET THE NATION'S
GROWING NEED TO ACCELERATE THE
DEVELOPMENT AND TRANSLATION OF
HIGH IMPACT BIO INNOVATION AND
TECHNOLOGY BY INCREASE THIG
CAPACITY AND RESEARCH
INFRASTRUCTURE OF THE HBCUs,
ENHANCING BME SCIENTIFIC
WORKFORCE AND DIVERSITY AND
ENRICHING THE DIVERSITY OF
PERSPECTIVES IN BME.
IN TERMS OF DIVERSITY, 2011
REPORTS THAT THE TIME 24% OF
RECIPIENTS RECEIVED THEIR
BACHELOR'S DEGREES FROM HBCUs.
KNOWING THERE'S ONLY THREE
BIOMEDICAL ENGINEERING PROGRAMS
AT HBCUs, WE'RE MISSING OUT ON A
HUGE OPPORTUNITY WITHIN THE
WORKFORCE.
TO BRING THOSE STUDENTS INTO
THE FOLD OF BME.
WE HEARD FROM JILL ON HOW
IMPORTANT IT IS TO GET DIFFERENT
PERSPECTIVES WHETHER WE'RE
TALKING ABOUT RACE, ETHNICITY,
DISABILITY OR OTHER POPULATIONS.
TO BRING IN THAT DIVERSITY WILL
ADD TO THE DIVERSITY OF
PERSPECTIVES.
THIS IS THE HEART OF SOUL OF
WHAT WE'RE TRYING TO DO.
WE WANT TO EXPAND EXPOSURE AND
ENHANCE COMPETITIVENESS FOR NIH
FUNDING.
WE ALL KNOW THAT HBCUs RECEIVE A
TINY FRACTION OF THE NIH
INTRAMURAL FUNDING OF WAY LESS
THAN 1%.
WE HOPE THIS COULD ALSO HELP
ENHANCE THE FACULTY'S ABILITIES
TO SUCCESSFULLY WIN NIH AWARDS.
WE TO HOPE WE CAN SUPPORT THE
CHAMPIONS WE KNOW ARE AT THE
UNIVERSITY.
THIS INITIATIVE WE HOPE WILL
LEAD TO A LONG-TERM PROGRAM
BEYOND THE FUNDING OF THE AWARD
AND LEND SUPPORT TO THE PEOPLE
ADD INSTITUTIONS DOING THE WORK.
WE CAN SERVE AS A RESOURCE TO
THEM AND HELP THEM AS THEY BUILD
THE BME COMMUNITY WITHIN THEIR
INSTITUTION.
ONE IS THROUGH THE TRANS-NIH
EBETA CENTER AND BRING POSTDOCS
AND GRADUATE STUDENTS AND
UNDERGRADS TO GET HANDS ON
RESEARCH AND BUILD
COLLABORATIONS ACROSS THE NIH
WE'RE LOOKING FORWARD TO
PARTNERING WITH THE BME
COMMUNITY AND PUBLIC AND PRIVATE
SECTORS AND THROUGH THE PROGRAM
HOPE TO DO THAT.
LAST BUT NOT LEAST DEVELOP
INNOVATIVE TECHNOLOGIES THEY CAN
CAPITALIZE ON FOR THE SPACE.
IN TERMS OF PROGRAM SUPPORT THIS
IS AN INITIATIVE TO SUPPORT
HBCUs TO MEET THE UNIQUE NEEDS
AND GOALS OF THEIR INSTITUTION
AND COMMUNITIES.
BEFORE I JOINED NIBIB I LED
LISTENING SESSIONS AND LED
LISTENING SESSIONS WITH MANY
SECTORS OF THE SCIENTIFIC
COMMUNITY SPECIFICALLY HBCUs AS
WELL.
WE MET DIRECTLY WITH SEVERAL
HBCUs AND ASKED WHAT DO YOU NEED
FROM NIH TO GET THE SUPPORT, THE
FUNDING AND OTHER RESOURCES YOU
NEED TO BE SUCCESSFUL?
AND ONE OF THE THINGS THAT
RESONATED WITH ME WAS OUR
ANNOUNCEMENT AND FOAs DON'T
REALLY FIT THEIR MODEL.
WITH THIS INITIAL WHILE THE ASK
IS WITH BME AND TECHNOLOGY WE
WANT TO KEEP IT BROAD.
WE WANT TO MAKE IT THEY CAN
APPLY FOR THEY CAN SUBMIT A
PROPOSAL WITHIN THEIR
INSTITUTION AND CAPABABILCAPABI.
ESTABLISHING BME DEPARTMENTS OR
ACADEMIC CENTERS, CERTIFICATE
PROGRAM MINORS AND RESEARCH
OPPORTUNITIES, MAKER SPACES,
CORE TECHNOLOGY FACILITY SUPPORT
AND FACULTY DEVELOPMENT I
MENTIONED EARLIER.
RESEARCH SUPPORT AND TRAINING
FOR THE FACULTY TO BUILD
COLLABORATION AND SKILLS WITH
THE NEW EQUIPMENT.
RESEARCH OPPORTUNITIES AND
CURRICULUM COURSE DEVELOPMENT
AND ENTREPRENEURSHIP.
TO NAME A FEW POTENTIAL IDEAS
THAT MIGHT FIT WITHIN THE HBCU
STRUCTURES AT THEIR
INSTITUTIONS.
WE'RE LOOKING TO PARTNER ACROSS
THE NIH WITH OUR SISTER I.C.
WE BRIEFLY TALKED TO A COUPLE
INSTITUTES AND THERE APPEARS TO
BE STRONG INTEREST IN THIS
ENDEAVOR AND LOOKING TO
ESTABLISH PATHWAYS TO BRING IN
THE EXTRAMURAL COMMUNITY TO
EXPERIENCE THIS.
I THINK THAT WAS BROUGHT UP
TODAY EARLIER THIS IS ON OUR
MINDS AND WE ARE HOPING IT USE
THE INITIATIVE TO BOLSTER THAT
MORE.
IN TERMS OF THE SUPPORT AND THE
VEHICLE WE'RE USING.
I LOOKED AT NIGMS PROGRAMS AND
THERE'S A COBRA PROGRAM THAT
USES GRANTS SO WE'RE POTENTIALLY
THINKING THAT AND MAYBE A
COOPERATIVE AGREEMENT.
WE'RE NOT 100% CERTAIN WHICH
DIRECTION WE'LL GO AND A LOT
DEPENDS ON WHAT OUR PARTNERSHIPS
ARE AND WHAT THAT LOOKS LIKE.
I SHOULD HAVE ALSO MENTIONED AS
MANY KNOW THERE'S A HUGE DEIA
INITIATIVE AND WE'RE HOPING TO
INTERACT WITH THAT PROGRAM
BECAUSE IT FITS IN NICELY AND
THERE'S POTENTIAL PARTNERS WE'D
LIKE TO TALK TO.
I KNOW COUNCIL HAS BEEN REALLY
INVOLVED IN THE IDEA AND
INITIATIVE AND LOOKING FORWARD
TO HEARING YOUR FEEDBACK AND ANY
SUGGESTIONS YOU HAVE MOVING
FORWARD.
THANK YOU VERY MUCH.
>>THANK YOU, SO MUCH ALBERT.
TERRIFIC PRESENTATION.
VERY EXCITED TO HEAR WHAT YOUR
ARE.
.
I KNOW WE'VE DISCUSSED THIS AND
JUST AS A REFRESHER, CONCEPT
CLEARAN
CLEARANCES WE'RE REGULARLY DOING
THIS AND PRECEDE AN ANNOUNCEMENT
FROM US THAT'S REQUIRED BUT FOR
THIS ONE IN PARTICULAR FOR THE
MOST PART WE DON'T REALLY
SPECIFY EXACTLY WHAT THE
MECHANISM WILL BE IN A CONCEPT
CLEARANCE BECAUSE WE DON'T QUITE
KNOW YET BUT IF WE DON'T DO A
CONCEPT CLEARANCE WE CAN'T HAVE
A MECHANISM.
WE WANTED TO GET THIS CONCEPT
CLEARANCE IN FRONT OF YOU, ASAP.
ALBERT, CAN YOU DO A CONCEPT
CLEARANCE RIGHT AWAY IN THE
FIRST COUNCIL MEETING AND HE HAS
RISEN TO THE OCCASION.
THANK YOU FOR PUTTING THAT
TOGETHER AND WITH HIS ENERGY
AND, ENTHUSIASM AND EXPERIENCE
WE'RE CONFIDENT WE CAN GET IT
OFF THE GROUND AND ON THE STREET
SOON.
WE WON'T HAVE DEFINITIVE ANSWERS
FOR YOU TODAY, PROBABLY BUT
WE'RE LOOKING TO DEVELOP
PARTNERSHIPS WITH OTHER I.C.s
AND HAVE POSITIVE RESPONSE.
WE'LL DO BUSINESS DEVELOPMENT IN
THAT REGARD LOOKING FORWARD TO
YOUR COMMENTS.
I'LL STOP TALKING NOW.
THIS IS THE EBETA CONSOLIDATION
OF BRAND.
THINK EVERYONE LIKES DATA AND TO
BROADEN APPEAL WE HAVE TO HAVE
SOMETHING ELSE AND TECHNOLOGY
ACCELERATION IS SOMETHING
EVERYONE LOVE.
WE LEARNED THAT AND THEY'RE
READY TO EMBRACE.
IS THE BRAND THAT PEOPLE WILL BE
FAMILIAR WITH FROM THE
INTRAMURAL SIDE AND IMMEDIATELY
GIVES HIM A CHANCE TO LEVERAGE
HIS WORK TO BUILD CONNECTIONS TO
THE EXTRAMURAL WORK.
>>THERE'S NOT SO MUCH OF A
RECOGNITION AS MUCH AS WE SAY
THIS IS HOW WE WANT TO DO IT
THEY'RE BOMBARDED RIGHT NOW AND
THE CAPACITY ISSUE IS HUGE.
THERE'S SO MANY OPPORTUNITIES
AND HOW DO YOU MANAGE PUTTING
SOMETHING TOGETHER AND IN A
SUPPORTIVE WAY HBCUs HAVE
SUCCESS AND TO BE HELPFUL AS A
COMMUNITY WE DON'T WANT TO TELL
SOMEBODY WHAT TO DO BUT IT MIGHT
BE GOOD THROUGH BETA AND MANU
AND HIS LEADERSHIP AND A
BLUEPRINT AND THINGS TO
CONSIDER.
PUT SOMETHING OUT TO BE HELPFUL.
I'M TELLING YOU, PEOPLE ARE
OVERWHELMED AND PEOPLE CAN'T BE
TRUSTED SO EVERY PARTNER WITH
THEIR HAND OUT IS NOT
NECESSARILY YOUR BEST FRIEND.
I BELIEVE WE'RE BEST FRIENDS AND
NEED TO SHOW IT IN A WAY THAT'S
RESPECTFUL AND HELPFUL.
>>THANK YOU SO MUCH.
THAT'S A GOOD IDEA.
WE TALKED ABOUT A WORKSHOP AND
DIFFERENT SCALES.
THE DIRECTOR AND CHAIRS ABOUT
HOW TO START A PROGRAM AND WE
DON'T WANT TO REINVENT THE
WHEEL.
WE WANT TO BE EFFICIENT WITH
TIME AND THE HALLMARK AT HBCUs
IS TEACHING WITH STUDENTS.
AND INVITING ALL OF YOU TO THE
MEETINGS TO SHOW THE BLUEPRINT
MODELS AND SHOW WE'RE HERE TO
HELP THE PROCESS.
THERE'S MORE COMING OUT ALL THE
TIME WITH THE INSTITUTIONS OR
UNITE INITIATIVE.
>>THANK YOU FOR LEADING THE
INITIATIVE.
I APPRECIATE YOUR INPUT.
WE LOOK FORWARD TO WORKING WITH
ALBERT.
ONE OF THE EXCITING THINGS I
FIND ABOUT THE NEW DATA CENTER
THE RESOURCES YOU TALKED ABOUT
AND SOMETIMES WE WANT TO TAKE
THE MENTEE AND MENTOR TO A
DIFFERENT PLACE AND THAT MAY BE
GOOD BUT IN THE AREA OF
BIOMEDICAL ENGINEERING I THINK
WE CAN IMPLEMENT MANY PROGRAMS
THAT ALLOW THEM TO COME HERE AND
WORK TOGETHER AS A TEAM AND GO
BACK TO THE IMPLEMENTING
INSTITUTION.
THE OTHER PART IS I REALLY LIKE
THIS BECAUSE I THINK IT'S GOING
TO BE THE ENGINE OF INNOVATION
TO HELP US IN THE MEDICAL FIELD
TODAY.
YOU SEE CLINICIANS COME FROM
MINORITY GROUPS GO BACK TO
ADDRESS THE PROBLEMS THEY SAW.
AN EXAMPLE IS STUDENTS THAT COME
TO DO RESEARCH IN MY LAB.
I'M ALWAYS AMAZED WHEN YOU ASK
THEM WHAT'S THE BEST THING YOU
CAN DO IN THIS WORLD IF YOU HAVE
ALL THE RESOURCES AND THEY COME
UP WITH CONCRETE PLANS RELATED
TO THEIR PERSONAL EXPERIENCE.
I SEE THE DIVERSITY PROGRAMS
YOU'RE CREATING WILL TRULY
ENRICH THE POPULATION AND WOULD
BE A GOOD CENTERS FOR
INNOVATION.
THANK YOU FOR THE WORK YOU ARE
DOING.
>>THANK YOU.
WHEN WE WERE BRAIN STORMING WE
REALIZED SOME INSTITUTIONS MAY
NOT BE ABLE TO BUILD A BIG
DEPARTMENT AND THAT'S OKAY THEY
MAY BE ABLE TO SPECIALIZE IN
PROSTHETICS OR KIDNEY DISEASE
AND THAT'S FINE AND WITHIN THE
REALM.
IF WE CAN GET THAT AT A FEW
INSTITUTIONS WE'RE AHEAD OF THE
GAME.
WE POTENTIALLY DOUBLE OR
PROGRAMS AT HBCUs SO THAT'S
HUGE.
WE'RE ON THE SAME PAGE IN TERMS
OF THE DIVERSITY OF PERSPECTIVE
PEOPLE FROM UNDER REPRESENTED
COMMUNITIES BRING IS HUGE.
AND TO YOUR POINT WE THINK THE
DATA CENTER WOULD BE A MECCA FOR
THE TRAINING EXPERIENCE TOGETHER
LEARNING THE TECHNOLOGIES AND
TAKING IT BACK TO THEIR HOME
INSTITUTIONS.
WE'RE HOPING TO DO THAT.
WE HAVE SET UP -- I PREVIOUSLY
IN MY OTHER INSTITUTES SET UP
R25s LIKE THAT THEY PROVED TO BE
EFFECTIVE.
WE'LL TALK ABOUT THE
MENTOR/MENTEE BUILDING PROGRAM.
>>THANK YOU FOR YOUR LEADERSHIP
AND I'M EXCITED FOR MANU.
FOR THE BETA CENTER IT'S
EXCITING.
I WANT TO ECHO WHAT SAM SAID
ABOUT BUILDING COMMUNITY BECAUSE
THE WHOLE SENSE OF BELONGING IS
IMPORTANT AND I HAVE A SPECIFIC
QUESTION ON THE FOOT NOTES ON
THE SUPPLIES WHERE IT SAYS IT'S
AN NSF REPORT YOU QUOTED IN 2011
THAT 24% OF BLACK SCIENCE AND
ENGINEERING DOCTORATE RESCIPIENT
RECIPIERECIPIENT
S RECEIVED THEIR DOCTORATE
DEGREES FROM HBCUs SO REACHING
OUT TO ALUMNI IS THERE A WAY TO
HAVE A COMBINATION WHERE IT'S
NOT JUST ONLY THE ALUMNI BUT I
THINK EVERYONE IS BOMBARDING
HBCUs RIGHT NOW.
ARE THERE RESOURCES TO SUPPORT
NETWORKING.
24% STRUCK ME.
SORRY, I'M NOT BEING VERY
ARTICULATE.
IN ESTABLISHING A SCIENCE OR
ENGINEERING NETWORK WITH HBCU
ALUMNI EVEN OTHERS WHO MAY NOT
BE FROM HBCU BUT MAY HAVE A
SPECIAL INTEREST WE KNOW THERE'S
LIMITED CAPACITY SOMETIMES HBCUs
SO COLLABORATION WILL BE A PART
OF THIS AND FORMING PARTNERSHIP.
WITH A WELL RESOURCED
INSTITUTION TO HAVE THE
STRUCTURAL SUPPORT.
ALL THIS IS ON THE TABLE.
I APPRECIATE YOUR COMMENT.
AND WE CALL IT INITIATIVE
BECAUSE IT'S OUR FIRST STEP AND
WE'RE TRYING TO FIGURE OUT WHAT
THAT MIGHT LOOK LIKE.
IT COULD DEVELOP LARGER
PARTNERSHIPS.
WE WERE TOYING WITH THE IDEA OF
WHAT TO CALL IT INITIATIVE
VERSUS PILOT.
IT'S THE FIRST STEP.
EVERYTHING IS ON THE TABLE.
YOUR COMMENTS ARE ALL VERY
VALUABLE AND WE'LL BE
CONSIDERING AS WE THINK HOW TO
EXPAND PARTNERSHIP WITH THIS.
ALL THE RESEARCH DOESN'T JUST
TAKE PLACE AT THE HBCU.
>>I WANT TO ECHO MY THANKS TO
THE TEAM THAT HAVE BEEN
THOUGHTFULLY PURSUING THIS OVER
YEARS.
ONE QUESTION HAS TO DO WITH
SUSTAINABILITY AND DEALING WITH
THE WHITAKER FOUNDATION AND
POURING MONEY INTO CREATING
PROGRAMS BUT WHEN THAT
DISAPPEARED IT WAS THE WEALTHIER
WELL RESOURCED PROGRAMS THAT
WERE ABLE TO THRIVE AND SOME
SUCCEEDED AND SOME DIDN'T.
I WONDER IF WE CAN THINK HOW TO
SUPPORT THE PROGRAMS ONCE WE SET
THEM UP?
ARE THERE WAYS TO STAFF THEM
WHETHER THEY'RE SMALLER PROGRAMS
THAT LEAD TO BIGGER ONES OR
EXTENDED FUNDING IS SOMETHING
THAT CAME TO MIND.
I'LL SAY A FEW WORDS AND TURN IT
OVER TO BRUCE BECAUSE HE'S A
WEALTH OF INFORMATION WHEN IT
COMES TO BUILDING OUTSIDE
PARTNERSHIPS AND MORE CONNECTED
TO MORE PEOPLE THAN I KNOW IN MY
LIFE.
WE TALKED ABOUT OTHER RESOURCES
AND SUPPORT BUT THE FUNDING IS
THERE.
WE'VE TALKED ABOUT FACULTY WITH
WORKSHOPS FOR WRITING GRANTS FOR
FUNDING FOR THEIR OWN LABS WE'RE
THINKING THROUGH THIS SO WE'RE
OPEN.
FOR ME WE DON'T WANT IT ONE AND
DONE AND WANT IT SUSTAINABLE
OVER DECADES SO MORE AND MORE
STUDENTS CAN PARTICIPATE AND HOW
WE BUILD THE COMMUNITY.
I'LL TURN IT TO BRUCE AND IF HE
HAS IDEAS ON ADDING TO THE
COMMENT THAT'S REALLY IMPORTANT.
>>ALBERT, THANKS.
GREAT QUESTION WE ALL
EXPERIENCED THE WHITAKER AND
THEY SAID YOU SHALL FORM A
BIOENGINEERING DEPARTMENT AND
SHOULD LOOK LIKE THIS AND GIVE
US ANNUAL REPORTS AND YOUR
PROVOST MUST PRESENT TO US AND
HAD RIGID YOU MUST DO THIS AND
THIS.
WE ALIGNED WITH THAT AND
BENEFITTED THE COMMUNITY BECAUSE
WE SUPPRESSED OUR THANKS ON WHAT
IS BIOENGINEERING AND DEFINED IT
ON A LARGE SCALE.
THIS IS DIFFERENT BUT THE SAME
IDEA OF STAKEHOLDERS IS
IMPORTANT BY REACHING OUT TO TO
INSTITUTES AND CENTERS, 14% OF
THE BUDGET IS SPEND ON
BIOENGINEERING.
THAT'S TOTAL BUDGET.
IF WE CAN GET PEOPLE ACCLIMATED
WE DON'T CARE WHAT YOU CALL IT
IT'S THE PEOPLE DEVELOPING IT WE
WANT TO SUPPORT.
UNLESS THERE'S A MIRACLE WE
WON'T DOUBLE OR TRIPLE OUR
BUDGET INSTANTANEOUSLY.
AND THE SECOND POINT YOU HAVE
CHAOS AROUND FOUNDATIONS AND DO
WHAT WE DID WITH COVID AND GET
PARTNERSHIPS GOING WITH THE
RIGHT PARTNERS AND DEPEND ON ALL
OF YOU.
YOU'RE ALL IN LEADERSHIP
POSITION TO MAKE THAT HAPPEN.
GILDA HAD IDEAS WITH
PARTNERSHIPS.
WE CAN FIGURE OUT A MECHANISM TO
MAKE IT WORK.
IF WE CAN CREATE SUSTAINABILITY
THROUGH THE STAKEHOLDER BUILDING
I KNOW I MAKE IT SOUND EASY, IT
WILL BE HARD BUT WE'RE IN A GOOD
POSITION BECAUSE EVERYONE THINKS
IT'S A GREAT IDEA.
EVERYBODY SAID IT'S ABOUT TIME.
HOW CAN WE HELP.
THAT'S A SNAPSHOT TO WHAT I'M
THINKING.
>>THANK YOU.
I LOVE THE IDEA AND BRUCE I LOVE
THE IDEA NIBIB BUILD SCAFFOLDS
AND THINGS THAT CAN BE EXPAND.
I ALWAYS GET EXCITED AND THINK
OF WAYS TO EXPAND MORE.
I'D LIKE TO THINK OF OTHER UNDER
REPRESENTS GROUPS AND HOW TO
PARTNER WITH THE TRIBAL COLLEGES
AND UNIVERSIT UNIVERSITIES AND
TO SEE THIS PROGRAM EXPAND
THERE.
>>THEY'RE NOT OFF OUR RADAR
THANK YOU FOR THE COMMENT.
THERE'S MORE LIMITED RESOURCES
IN TERMS OF THE RESEARCH
INFRASTRUCTURE.
AND MORE PARTNERSHIP AND
COLLABORATIONS WITH OTHER
INSTITUTIONS PUTTING THE HARD
BEFORE THE HORSE BUT ALL TO SAY
WE HOPE IT'S OUR FIRST STEP IN
GOING THAT DIRECTION.
>>PARTNERSHIP AT NSF AND
THEY'VE DONE WELL WITH TEACHER
TRAINING FOR EXAMPLE.
TWO THINGS CAME TO MIND
COMMUNITY COLLEGES TO DRAW
STUDENTS THAT HBCUs DRAW UPON
AND A SUPPORT STRUCTURE FOR
LINKING COMMUNITY COLLEGES WITH
THE HBCUs AND THE TEACHER
TRAINING NOT QUITE HIGH SCHOOL
BUT THE CONCEPT TO BRING THAT
MAY BRING IT IN THE FUTURE AND
OFFER OUR EXPERIENCES AND THEY
GO BACK TO THE HBCU WHERE THEY
DON'T HAVE SUPPORT OR ABILITY TO
DO RESEARCH AND CAPACITY
BUILDING WITHIN THE HBCU ITSELF
HAVING SPENT TIME AT A
MINORITY-SERVING INSTITUTION I
CAN TELL YOU HOW IMPORTANT IT IS
YOU HAVE CAPACITY IN THAT
INSTITUTION YEAR ROUND.
SUMMER EXPERIENCE GREAT BUT NO
GOOD IF THEY ONLY GET SUMMER
EXPERIENCE AND THEN GO TO
ANOTHER INSTITUTION BUT DON'T
CHANGE THE OVER ALL CAPACITY AND
CAPABILITY OF THE INSTITUTION.
IT'S FANTASTIC TO SEE THE
PROGRESS YOU GOT IT OUT THE
DOOR.
NOT YET BUT WE APPRECIATE BOTH
COMMENTS WE HEARD HBCUs THEY
PARTNER WITH THE INSTITUTION AND
THEY GET THE GRANT.
WE DON'T GET THE INDIRECT.
IT'S IMPORTANT THE AWARD IS MADE
TO HBCUs FULL STOP.
WE'RE NOT ENVISIONING EVERY HBCU
WILL HAVE THE CAPACITY TO PULL
IT TOGETHER.
THERE'S SUSTAINABILITY ISSUES
AND HOPING THOSE THAT HAVE THE
CAPACITY AND CHAMPIONS WE CAN
PROVIDE THE EXTRA STIMULUS IN
SOME WAYS SO THEY CAN BUILD THE
PROGRAM WHATEVER IT LOOKS LIKE
AND ALSO THEY HAVE THE RESEARCH
INFRASTRUCTURE.
MAYBE THEY CAN GET AN
INFRASTRUCTURE GRANT.
UNITE WILL ISSUE THE TYPES OF
REPORTS.
WE'RE HOPING IT WILL BE ANOTHER
SOURCE OF INCOME SO STUDENTS CAN
DO RESEARCH THERE AND THE
COMMUNITY COLLEGE IS A GOOD
POINT FOR TRAINING TEACHERS AND
A LINK FOR STUDENTS TO
TRANSITION TO THE HBCUs BECAUSE
WE NEED A STUDENT BODY THERE
INTERESTED IN THE PROGRAMS.
THEY'RE VERY STRONG.
I TOOK NOTES IT'S PROBABLY
SOMETHING WE WANT WATH ON IN THE
FIRST ANNOUNCEMENT.
THANK YOU.
>>SUSAN AND DAN.
>>THE NSF WOULD LOVE TO
PARTNER.
WE HAD CONVERSATIONS ABOUT THE
MANY WAYS THE ENGINEERING
DIRECTORATE AND THE EDU
DIRECTORATE AT NSF COULD BE
IMPORTANT PARTNERS WITH NIH AND
NIBIB AND PROPELLING FORWARD THE
IDEAS YOU'VE PROPOSED TODAY.
THEY GO FROM EARLY ENGAGEMENT
ENGINEERING FOR USA AND TEACH
ENGINEERING FOCUSSED ON THE K-12
TO HAVE A DEMOCRATIZING APPROACH
HOW BIOENGINEERING IS SOMETHING
ENGAGING.
IT'S AN EFFECTIVE PROGRAM
EXPANDED TO HALF THE STATES AND
OVER 500,000 HIGH SCHOOL
STUDENTS AND EMPHASIS ON UNDER
REPRESENTED AND INNER CITY
COMMUNITIES.
THOSE ARE OPPORTUNITIES FOR THEM
TO ENVISION THEMSELVES AND APPLY
FOR THE PROGRAMS.
AND IMPORTANT TO RECOGNIZE MANY
AWARDS ARE GOING TO
BIOENGINEERING BECAUSE THEY'RE
THINKING HOW TO REVOLUTIONIZE
ENGINEERING DEPARTMENTS.
IT DOESN'T HAVE TO BE AN
EXISTING DEPARTMENT IT COULD BE
A NEW DEPARTMENT.
THE OPPORTUNITY TO TALK ABOUT AN
ENERGY BETWEEN PROGRAMS
ESTABLISHED AT NSF AND
BROADENING THAT.
WE HAVE A PROGRAM TO LOOK AT
THOSE AWARDS AND THEY WENT TO
STUDENTS WHO ARE LATINX AND A
THIRD ARE IN HBCUs AND WHAT I
THINK ABOUT THE CONCEPT IT
INCLUDES ELEMENTS OF WHAT CAN WE
DO RIGHT NOW AND HOW DO WE
CREATE THE CONTINUITY PATH SO
WHAT WE BUILD IS SUSTAINED IN
THE FUTURE.
I LOOK FORWARD TO PARTNERSHIPS
ON ALL OF THAT WITH NIH.
>>THERE'S A LOT TO UNPACK AND
I'LL REACH OUT TO TALK ABOUT
THAT.
AS WE THINK OF PIPELINE, THOSE
JUNIORS AND SENIORS, EVEN SOME
-- SOPHOMORES AND START SHARING
WHAT EXISTS AT AS CAREER MAJORS
WOULD BE SO VALUABLE.
THAT'S ONE LITTLE PIECE AND
POSTDOCS ARE A GREAT RESOURCE.
WHAT BETTER MENTOR TO HAVE THAN
POSTDOCS THAT HAVE GONE THROUGH
IT AND SHARE LIFE EXPERIENCES AS
WELL AS THE SCIENCE.
>>THE SUCCESS RATE FROM VARIOUS
INSTITUTIONS NOT P.I.,
DEMOGRAPHICS BUT THE
INSTITUTIONS.
AND ONE OF THE THINGS I WANT YOU
TO EMBED IN YOUR PLANNING IS HOW
TO EDUCATE THE COMMUNITY YOU'RE
EXPECTING TO WRITE THE GRANTS TO
GIVE THEM A COMBINED OF
TUTORIALS THAT ARE MISSING AT
NIH AND FRANKLY AT NSF.
IT'S SPOTTY AT NSF.
WHAT GOES IN A BUDGET?
BECAUSE ACTUALLY THAT ENTIRE
BUDGET DECLARATION IS LIKELY NOT
A GRANTS ADMINISTRATOR BUT THE
P.I. THEMSELVES.
SO TO PREPARE THOSE PEER, IF YOU
WILL, PEER GUIDELINES FOR WHAT
GOES IN WHAT PART OF THAT GRANT
WILL REALLY HELP ENSURE THE
FUNDAMENTAL ASPECT WHICH IS GOOD
PROPOSALS SUBMITTED TO THE
PROGRAMS YOU LAUNCH.
>>YOU'RE HITTING THE NAIL ON
THE HEAD.
AT NIDA I BUILT ON THE PROGRAM
THAT I RENAMED THE COLLEGE
NETWORK AND WE DID JUST THAT.
WE PAIRED POSTDOCS THAT WERE
WITH NIH FUNDED GRANTEES AND
THEY WERE THE COACHES OVER A
FOUR-MONTH PERIOD.
WE HAD TWO WORKSHOPS AND THEY
HAD AN INTERIM GRANT WRITING
PERIOD AND WE HAD A GRANT REVIEW
AND THEY GOT TO LISTEN TO
EVERYONE'S GRANT BE REVIEWED.
IT'S A BEAST IT MANAGE AND RUN
AS A PROGRAM SO I CAN'T DO THIS
AS I LEARN THE NEW JOB
RESPONSIBILITIES I HAVE BUT WITH
HELP WE CAN DEFINITELY BUILD
THIS IN IS THE PROGRAM IS
EFFECTIVE.
I AGREE WE HAVE PEOPLE FROM
HBCUs WHO PARTICIPATE AND THEY
WERE GETTING AWARDS.
THANK YOU.
I'LL REACH OUT AT SOME POINT.
>>PLEASE DO.
>>THANK YOU DAN AND CATHY.
CATHY I THINK YOU'LL WRAP IT UP.
WE CAN'T DO THIS PROGRAM WITHOUT
THE NSF PARTNERSHIP.
SUSAN AND I TALKED ABOUT THIS.
THIS IS ONE OF THE MOST EXCITING
AREAS OF CO-INVESTMENT FOR US
YOU MADE IT POSSIBLE TO CONCEIVE
OF DOING THIS TYPE OF PROGRAM
SUCCESSFULLY.
WE'LL WORK ON THE DETAILS AS WE
TAKE OUR HIGH-LEVEL VISION DOWN
INTO THE OPERATIONAL DETAILS OF
HOW IT WILL UNFOLD.
THANK YOU, SUSAN.
>>YOU CHALLENGED OUR COUNCIL
MEMBERS TO PROVIDE SUGGESTS FOR
PARTNERSHIPS.
ONE THING THAT POPPED TO MIND IS
IN ADDITION TO ACADEMIC AND
INDUSTRIAL PARTNERSHIPS IT MAY
BE A GOOD IDEA TO THINK OF
HOSPITAL SYSTEMS.
I CAN TELL YOU THERE'S A GREAT
HUNGER IN MANY HOSPITAL SYSTEMS
FOR ENGINEERING TO SOLVE
PRACTICAL PROBLEMS.
AS ROD CAN ATTEST IT'S IN
DEPARTMENTS.
I THINK THERE'S INTERESTING.
>>WE HAVE OUTSIDE THE BOX
IDEAS.
I'LL DEFINITELY THINK ABOUT THAT
AND MY COLLEAGUES ARE MORE
KNOWLEDGEABLE THAN I AM IN TERMS
OF THE ENGINEERING CAPABLES AT
HOSPITAL SYSTEMS.
THANK YOU VERY MUCH.
I APPRECIATE THAT.
>>CATHY AND I'M GOING TO
REVERSE MY PREVIOUS DECISION SO
RON WILL HAVE THE LAST WORD.
>>QUICKLY, WE LEARNED WE CAN
LEAD THE WAY FOR NEW PATHWAYS
FOR DOING THINGS AND YOU DIDN'T
MENTION GATHERING DATA ON WHICH
OF THESE IDEAS AND ANALYZING HOW
SUCCESSFUL THEY ARE AND WHAT
DOES AND DOESN'T WORK AND IT
WILL BE IMPORTANT AND HELPFUL TO
PROVIDE GUIDANCE TO OTHER
INSTITUTES AND YOUR PARTNER
GROUPS ON WHAT DOES AND DOESN'T
WORK.
PARTICULARLY THE IDEAS THAT
DON'T WORK SO PEOPLE DON'T
REINVENT THE WHEEL ON THINGS
THAT ARE NOT GOING TO WORK WHERE
THINGS ACROSS THE BROAD SPECTRUM
OF PARTNERS VERSUS MENTORING
VERSUS CREATING DEPARTMENTS
VERSUS ALL THE DIFFERENT IDEAS
YOU HAVE.
I THINK GATHERING THE DATA AND
REPORTING THAT OUT WILL BE
IMPORTANT AS WELL.
>>YEAH, THAT'S A GOOD POINT.
I LOVE BEING DATA DRIVEN.
SOME OF THIS IS A LITTLE BIT
HARD TO GET THE DATA RIGHT
BECAUSE WHEN A PROGRAM DOESN'T
SUCCEED BUT BRINGING PROGRAMS
THAT HAVE BEEN SUCCESSFUL AND
SHARING THAT RELAYING THAT
INFORMATION PASSING IT FORWARD
CAN HELP.
WE ALWAYS KEEP DATA ON OUR MINDS
AT NIH.
WE'LL TRY TO INCORPORATE DATA AS
MUCH AS POSSIBLE AND LOOK AT AS
WE GO THROUGH.
INSTITUTIONAL COMMITMENT HAS TO
BE THERE AND I HAVE TO MAKE SURE
THE INSTITUTIONAL COMMITMENT'S
THERE.
EVEN IF YOU HAVE THE CHAMPION IF
THE COMMITMENT IT'S NOT THERE
WE'VE SEEN THEM LIVE BEYOND THE
LIFE OF THE AWARD.
WE'LL TEAM THAT IN MIND.
THANK YOU VERY MUCH.
>>ROD, TAKE IT AWAY.
>>THANKS, BRUCE.
>>FIRST, LET ME SAY HOW MUCH I
APPRECIATE THE OPPORTUNITY TO BE
CONTINUE TO BE INVOLVED.
AND ALSO TO OBSERVE THE GREAT
IMPACT NIBIB IS HAVING ON THE
NATION.
THE DISCUSSION THAT I HEARD WHEN
I FIRST GOT ON POINT OF CARE
TESTING AND HOW IT WAS GOING AND
ADVANCING.
AND THE DEVELOPMENT OF THIS
PROGRAM IS JUST SO INSPIRING TO
HEAR THIS.
ONE OF THE COMMENTS BRUCE MADE I
REALLY WANT TO UNDER SCORE ABOUT
THE VALUE OF CONTINUANCE
MONITORING ON A CONTINUOUS TIME
SCALE NOT IN THE SNAPSHOTS WHERE
WE ARTIFICIALLY ACQUIRE DATA.
IT TENDS TO BE CYCLING BUT IN A
CONTINUOUS FASHION.
THERE'S INFORMATION THAT CAN BE
PREDICT AND THINKING OF THIS AS
THE NEXT FRONTIER IS FORWARD
THINKING AND I ENCOURAGE AND
SUPPORT THAT.
REGARDING THE BETA INITIATIVE
AND GREAT PRESENTATION BY ALBERT
AND I RESONATED WITH EVERYTHING
YOU SAID.
YOU MENTIONED OFTEN OUR FOAs
DON'T FIT HBCUs.
THAT'S A KEY POINT.
IT CAN'T BE OVER EMPHASIZED NOT
ONLY DO THE FOAs NOT FIT HBCUs
AND UNDERSTAND THE TARGET
COMMUNITY FOR WHICH THIS IS
BEING DEVELOPED AND DIRECTED.
WE NEED TO BE EFFECTIVE AND
RECOGNIZE HBCUs WHILE MENTIONED
AS ONE ARE NOT JUST ONE.
THEY'RE NOT A MONOLITH.
BRUCE, THE 15 YEARS I WAS THERE
WHEN WE SAT AROUND AT THE TABLE
AND SAID IF YOU SEE ONE, I SEE.
I DOUBT THAT'S CHANGED.
41 INSTITUTES AND CENTERS.
EACH ONE IS DIFFERENT AND SAME
WITH HBCUs.
WE CAN ATTEST THEY'RE DIFFERENT
AND I'M A GRADUATE OF MOREHOUSE
AND IT'S DIFFERENT FROM SPELLMAN
AND IT'S QUITE COLLABORATIVE AND
AND ACROSS FROM CLARK HAS A
GRADUATE PROGRAM ALSO QUITE
DIFFERENT.
AND I LEARNED THIS WEEKEND CLARK
HAS A Ph.D. PROGRAM OTHER
SCHOOLS DON'T HAVE.
IT STARTED ME THINKING THE A.U.
CENTER AS A WHOLE MAY BE
APPROACHED AS A PLACE WHICH
COLLECTIVELY CAN HAVE A PROGRAM
TO LEVERAGE THE STRENGTHS OF THE
MULTIPLE INSTITUTIONS THAT MAKE
UP THE A.U. CENTER.
JUST A THOUGHT AND
CONSIDERATION.
THE MAIN POINT IS THEY'RE NOT
MONOLITH.
WHILE THERE ARE COMMONALITIES
AROUND THEM CENTERED AROUND
CAPACITY AND THERE'S A CONCERN
WHEN TRAINEES GO AWAY AND DON'T
HAVE THE INFRASTRUCTURE TO
SUPPORT AND CONTINUE THE
CAPACITY ISSUE MAY BE COMMON
AMONGST MANY HBCUs BUT THEY'RE
NOT ALL THE SAME.
WE TALKED ABOUT NEXT STEP HAVING
A CONVERSATION WITH
REPRESENTATIVES FROM THE HBCUs.
I STILL SEE THAT AS A CRITICAL
NEXT STEP.
SO WE UNDERSTAND THE COMMUNITY
WE'RE TRYING TO AFFECT AND
AFFECT.
THAT'S A CRITICAL NEXT STEP AS I
SEE IT AND IN YOUR PLANNING I
ENCOURAGE THAT.
NOW HAVE YOU SOMEBODY NEW ON
BOARD YOU HAVE SOMEBODY TO LEAD
THE CHARGE AND AFFECT IT AND I'D
BE HAPPY TO PARTICIPATE AS I'M
SURE GILLDA WILL AT LATEST
INTELLECTUALLY BUT SHE'S
PRESIDENT OF SO MANY THINGS I
DON'T KNOW HOW SHE'LL HAVE TIME.
SHE'S ON HER THIRD OR FOURTH
PRESIDENCY RIGHT NOW.
ANYWAY, THOSE ARE MY COMMENTS.
>>THANK YOU SO MUCH FOR
EVERYTHING YOU HAVE DONE.
I'VE HEARD ABOUT THE GROUND WORK
YOU GUYS HAVE LAID.
I'M JUST A CATALYST TRYING TO
GET THIS GOING AND I WOULD BE
RELYING ON YOU AND OTHERS HERE
FOR ALL THAT.
WE HAVE TO DO MARKET RESEARCH.
YOU'VE SEEN ONE YOU'VE ONLY SEEN
ONE.
NOW THAT IT'S OUT WE CAN HAVE
CONVERSATIONS MORE OPENLY AND
START TO LEARN WHAT IT IS THEY
WANT OR NEED RATHER.
YOU RAISED A GOOD POINT AND WE
PROBABLY NEED TO INCORPORATE
LANGUAGE THAT MULTIPLE
INSTITUTION PARTNERSHIP.
WE NEED TO THINK HOW TO
INCORPORATE THAT INTO THAT.
THAT'S ANOTHER BOX THAT'S AN
IMPORTANT COLLABORATION.
THERE'S TREMENDOUS OPPORTUNITY
IN TERM OF WHO MAY BE INTERESTED
PARTNERING WITH THEIR SISTER
INSTITUTIONS.
THAT'S SOMETHING ALSO ON HERE.
I'LL BE REACHING OUT TO YOU
BECAUSE WE WANT TO HAVE THE
CONVERSATIONS AS WE MOVE FORWARD
TO MAKE SURE WE HEAR FROM THEM
AND WHAT THEY NEED.
I DO APPRECIATE EVERYTHING YOU
SAID AND I LOOK FORWARD TO
WORKING WITH YOU ON THIS.
>>SO JUST TO MENTION YVONNE
MADDUX IS A RESOURCE.
SHE'S ACTIVE IN THIS AREA.
SHE STILL TONIGHT TO BE INVOLVED
IN THE COMMUNITY WITH HBCUs AND
AN NSF INITIATIVE.
SUSAN, I DON'T KNOW IF YOU KNOW
HER BUT SHE'S INVOLVED WITH
MORGAN STATE AND ONE OTHER HBCU
WHO ARE APPLYING AND TALKED TO
HER RECENTLY ABOUT THAT.
>>THANK YOU, BRUCE.
I WANT IT THANK EVERYBODY FOR
YOUR FEEDBACK.
TREMENDOUS INPUT AND YOU ARE A
WEALTH OF INFORMATION.
I LOOK FORWARD TO WORKING WITH
YOU AS WE MOVE FORWARD.
>>THANK YOU, ALBERT.
THANK YOU, ROD.
I WANT TO WRAP THIS UP BY
REINFORCING ROD GAVE SPECIFIC
SUGGESTIONS.
I'M HOPING WE CAN DO THAT
[AUDIO DIFFICULTIES]
>>IT'S HARD TO HEAR.
WE HEAR SCRATCHY.
>>OKAY.
HOW'S THAT?
>>SEND US NAMES.
WE'LL FOLLOW UP AND MORE TO
COME.
THANK YOU.
DAVID.
BACK TO YOU.
>>THANK YOU SO MUCH.
SO IT'S A QUARTER AFTER 3:00 SO
COUNCIL MEMBERS AS YOU SAW FROM
THE CONFIDENTIAL INFORMATION WE
HAVE A SESSION SO WE SHOULD BE
FINE ON BEING COMPLETED IN AN
APPROPRIATE TIME.
WE DON'T HAVE TO EAT TOO MUCH
INTO MORIA'S PRESENTATION.
>>I MANAGE THE BIOROBOTIC
SYSTEMS AND WOULD LIKE TO
ANNOUNCE OTHERS VIRTUALLY IN THE
RUME FROM THE OFFICE OF SCIENCE
POLICY, OSP FOR SHORT.
WE HAVE A TEAM LEAD FOR CLINICAL
RESEARCH POLICY AT OSP AND A
PROGRAM OFFICER FOR BIOETHICS AT
OSP.
WE'LL TALK ABOUT RESEARCH ON
BIOETHICAL ISSUES RELATED TO
BIONIC ROB BOUGHTIC DEVICE
DEVELOPMENT AND TRANSLATION AND
THIS PHOTO FROM SCIENCE REVIEW
ILLUSTRATES HOW ROBOTIC AND
BIONIC DEVICES ARE RELEVANT IN
MANY ASPECTS OF AND HAVE A WIDE
RANGE OF USES FROM OUTSIDE THE
OPERATING ROOM TO THE CLINIC.
WE SEE EXAMPLES OF ROBOTICS USE
FOR SURGERY AND IMAGING
ASSISTANCE AND ROBOTICS THAT CAN
BE SWALLOWED IN THE G.I. SYSTEM
FOR IMAGING AND DIAGNOSTICS AND
WORN EXTERNALLY LIKE AN
EXOSKELETON AND AN ASSISTED
WEARABLE ARM OR AND THESE ARE
EXAMPLES AND BY NO MEANS THE
CAPABILITIES WE HAVE TODAY.
NIDND IS INVESTED IN THE
TECHNOLOGIES AND WANTED TO SHOW
YOU OVER THE PAST FIVE YEARS
WHAT OUR INVESTMENT HAS BEEN TO
ESTABLISH SOME RELEVANCE.
THESE ARE BROAD CATEGORIES I
DIVIDED UP THE PORTFOLIO INTO SO
GET A SENSE OF WHAT WE'RE
FUNDING.
APPROXIMATELY $20 MILLION HAS
GONE INTO BIONIC AND ROBOTIC
RESEARCH AT NIBIB AND THERE'S
OTHER INSTITUTES AT NIH THAT
FUND ROBOTIC AND BIO ONIC
RESEARCH.
WE'RE TALKING ABOUT NIBIB TODAY.
WITH THE FIELD HAS GROWN ETHICAL
CONCERNS.
THERE'S A PHOTO OF A YOUNG CHILD
WEARING AN EXOSKELETON BEING
EVALUATED BY A CLINICIAN.
IT'S ONE EXAMPLE OF POSSIBLE
QUESTION MAY ARISE.
WHAT IS THE LEVEL OF AUTONOMY
THAT'S APPROPRIATE?
SHOULD THE DEVICE BE CONTROLLED
BY A RESEARCHER IN A CLINIC OR
SHOULD THE PERSON USING THE
DEVICE HAVE FULL AUTONOMY?
WHAT'S THE TRADE-OFF LOOK LIKE
AND WHAT ARE LONG-TERM
IMPLICATIONS OF USING THE
DEVICE.
FOR AN INVASIVE DEVICE WE LOOK
AT POSSIBLE SITUATIONS OF
MAINTENANCE AND CARE NEEDED OR
IF A DEVICE IS REMOVED AND WHAT
TYPE OF EQUITABLE ACCESS IS
APPROVED FOR THE DEVICE.
IS THE DEVICE BASED ON A
POPULATION THAT USES THE DEVICE
AND TAKING INTO ACCOUNT POSSIBLE
STIGMAS TO AUGMENT OR ASSIST
BEHAVIORS.
AND WHAT ARE RISKS OF USING A
DEVICE USING OTHER TRADITIONAL
PRACTICES.
WE KNOW HOSPITALS TEND TO
PROMOTE NEW TECHNOLOGIES OR
ADVERTISE ROBOTIC SURGERY IS
THERE A BENEFIT TO THE PERSON
GETTING THE PROCEDURE VERSUS
OTHER INTERVENTIONS THE PROPOSED
SCOPE OF THE FUNDING OPPORTUNITY
AND CONCEPT TO DO THIS WE ARE
PARTNERING WITH THE OFFICE OF
SCIENCE POLICY, OSP.
THERE'S A GREAT HISTORY OF
FUNDING AND MANAGING AND TALKING
ABOUT ETHICS RESEARCH AT NIH.
WE WANT TO SUPPORT RESEARCH THAT
ANALYZES AND/OR ADDRESSES BIO
ETHICAL ISSUES RELATED TO BIONIC
DEVICES AND OUR GOAL IS TO
CULTIVATE A COMMUNITY AND
POTENTIAL OUTCOMES OF THE
CONCEPT AND FUNDING OPPORTUNITY
WOULD BE THERE WOULD BE A ROBUST
BIOETHIC EVIDENTIARY BASE TO
INFORM POLICY DECISIONS AND TELL
US WHAT IS GOING ON THROUGH THE
DEVICE'S LIFE SPAN.
SOME EXAMPLES ARE ESTABLISHING
BEST PRACTICES, MAYBE DESIGN
PRINCIPLES OR JUSTIFICATION FOR
REIMBURSEMENT FOR USING A DEVICE
VERSUS OTHER CLINICAL
INTERVENTIONS.
ON THE RIGHT THERE'S A DA VINCI
ROBOT AND ABOUT 8.1 MILLION
PROCEDURES HAVE BEEN DONE WITH
THE ROBOT SO THE PREVALENCE IS
THERE.
THESE EXAMPLES ARE SUGGESTIONS
WE HAVE COME UP WITH IN INTERNAL
DISCUSSIONS.
WE'RE INTERESTED IN ETHICAL
ISSUES PERTAINING TO THE
RESEARCH AND DEVELOPMENT OF
ROBOTIC DEVICES.
CONCERNS ABOUT HOW PARTICIPANTS
ARE REPRESENTED IN THE STUDY
DESIGN AND SELECTED.
INFORMED CONSENT PRACTICES AND
ARE THE SUBJECTS ABLE TO PROVIDE
INFORMED CONSENT AT THE
APPROPRIATE LEVEL.
WHAT ARE LONG-TERM OBLIGATIONS
SO THE RESEARCH PARTICIPANTS
PART OF THESE STUDIES?
AND WE'RE INTERESTED IN ETHICAL
IMPLICATIONS RELATED TO HOW THE
DEVICES ARE BEING USED.
WHO HAS THE AUTONOMY AND WHAT IS
THAT TRADE OFF.
HOW ARE WE LOOKING AT ACTIVATION
AND WHO IS MONITORING THE
DEVICE.
IS THE DATA OF THE USER SECURE
AND WHERE IS THAT HANDLED?
AND EQUITABLE AVAILABILITY OF
THE DEVICE TO DIFFERENT
POPULATIONS AND SOME BARRIERS
THAT MIGHT EXIST THERE.
ALSO, WE'RE INTERESTED IN RISK
AND BENEFIT ANALYSIS OF USING
BIONIC AND ROBOTIC DEVICES.
HOW CAN RECREATE A SUCCESSFUL
BIOETHICS FUNDING OPPORTUNITY?
THE FUNDING MECHANISM WE
DISCUSSED AND DECIDED ON WOULD
BE AN R21.
THIS RELATIVELY KNOWN BUT
COMMONLY KNOWN GRANT WE BELIEVE
WOULD GET THE PROPER SCOPE OF
TACKLING THE ETHICAL QUESTIONS.
WE WOULD IMAGINE STRUCTURING IT
SIMILAR TO THE R21 AND
ANTICIPATE TWO RECEIPT DATES ONE
IN FISCAL YEAR 2023 AND FISCAL
YEAR 2024 TO GET A GOOD SENSE OF
WHAT'S OUT THERE AND EVEN ALLOW
FOR RESUBMISSIONS.
WE KNOW IT WILL BE A NEW UNIQUE
TYPE OF RESEARCH AND AN
IMPORTANT POINT IS THIS WOULD BE
REVIEWED BY A SPECIAL EMPHASIS
PANEL AND LIKELY A COMBINATION
OF ETHICISTS AND CLINICIANS TO
GET AN UNDERSTANDING OF WHAT THE
PROBLEMS ARE.
I WANTED TO EMPHASIZE THE
FUNDING WOULD BE TO FOCUS ON THE
BIOETHICS RESEARCH AND WE HAVE
FUNDS TO DEVELOPMENT OF
TECHNOLOGY BUT WANT TO MAKE SURE
THE ETHICS IS THE FOCUS OF THESE
PROPOSALS.
HOW DO WE GET THE COMMUNITY TO
COME TOGETHER?
OUTREACH IS IMPORTANT.
IT'S GOING TO BE A NEW
INTERDISCIPLINARY COMMUNITY.
WE COULD USE YOUR HELP AS
COUNCIL MEMBERS MANY HAVE
DEPARTMENTS WITHIN YOUR
UNIVERSITY OR TANGENTIAL TO YOUR
INSTITUTION THAT TACKLE ETHICAL
ISSUES AND YOUR CONNECTION CAN
BE OF GREAT BENEFIT TO US.
INTERNALLY WE'RE PROPOSE
WEBINARS TO GET AT NEW COMMUNITY
MEMBERS AND WE HAVE VARIOUS
SOCIAL MEDIA CHANNELS AND
PRACTICE IN THIS ETHICAL AREA.
AND TO ENGAGE WITH FEDERAL
AGENCY PARTNERS THAT CAN EXPRESS
INTEREST AND CAN CONNECT US WITH
OTHER SCIENTISTS AND ETHICISTS
IN THE COMMUNITY.
I'D LIKE TO OPEN UP THE FLOOR
FOR COMMENTS AND QUESTIONS.
THANK YOU.
>>THANKS, MORIA.
LOOKS LIKE SAM IS UP FIRST.
>>THIS IS GREAT.
THANK YOU VERY MUCH.
I'M INSPIRED YOU'RE LOOKING INTO
THE CHALLENGES.
THERE'S REGULATORY PROCESS
INVOLVED WITH THE DHI FORMATION
AND OTHER REGS WHICH IS REALLY
STIFLING FOR A LOT OF
INVESTIGATORS.
IS THERE PLANS TO HAVE A
DATA-DRIVEN DATABASE TO ALLOW
PEOPLE TO GET ACCESS TO WHAT WE
CAN HAVE WITHOUT GOING THROUGH
ALL THE LOOPHOLES IN ORDER TO
USE THE DATA FOR APPLICATIONS
AND THAT GOES TO WHERE THE
BIOETHICS COMES IN.
IF THE PATIENT IS HAPPY AND
WILLING TO PARTICIPATE AND GET
THE INFORMATION WOULD THAT MAKE
OUR LIVES EASIER FORWARD.
>>I THINK YOU'RE GETTING AN
UNDERSTANDING OF HOW RESEARCH
PARTICIPANTS WANT TO SHARE THEIR
DATA MAYBE AND IF THERE'S
APPROPRIATE WAY IF THEY AGREE TO
TO DO SO AND
>>ITEM THINKING ABOUT PATIENTS
THEMSELVES AND WE CAN HAVE
PATIENT-DRIVEN WAYS TO MINE DATA
IN THE RARE DISEASES SYSTEMS
WHERE WE WANT TO KNOW MORE
THROUGHOUT THE WORLD WOULD IT
MAKE THE BIOETHICS REGULATIONS
EASIER IF PATIENTS CREATE THEIR
PATIENT-DRIVEN DATABASE IN THE
FUTURE?
>>I THINK IT'S A GREAT CONCEPT.
THERE'S EXAMPLES OF EXEMPLARY
PATIENTS THAT GO ABOVE AND
BEYOND TO SHARE THEIR EXPERIENCE
WITH THE WORLD.
THAT WOULD BE A GREAT PROPOSAL
LOOKING AT THE RESTRICTION ON
PATIENT DATA AND HOW COULD A
PATIENT BE THE SOURCE OF DATA
FOR OTHER RESEARCHERS IN A
PROTECTED AND SHAREABLE WAY.
THANK YOU.
>>IT'S WONDERFUL TO SEE YOU
GETTING IN FRONT OF THE ISSUE
AND I'M REMINDED ABOUT THE
RETINAL IMPLANT THAT FAILED AND
THE COMPANY WENT OUT OF BUSINESS
AND NOW THE PATIENTS WERE BLIND
WITH NOTHING TO DO AFTER
EXTENSIVE AND TRAUMATIC SURGERY.
I WOULD LOVE IT MAKE SURE YOUR
INTERDISCIPLINARY GROUP INVOLVES
THE RESEARCHERS AND INDUSTRY AND
REGULATORY AGENT AND PATIENT
ADVOCATES AND THE SCOPES OF
PEOPLE ENGAGED IS STUPENDOUS.
GOOD LUCK.
SOUNDS LIKE A WONDERFUL THING TO
DO AND CAN THINK OF PEOPLE I'D
LIKE TO GET WORD OUT TO SO LET
US KNOW WHEN YOU HAVE FIRST
GATHER
GATHERINGS.
>>THANK YOU.
>>RANU.
>>NICE TO SEE IT'S BEING
CONSIDERED AND IN THE DISCUSSION
OF NEW TECHNOLOGIES IMPLANTED OR
BEING USED LIKE THIS.
ONE WOULD BE THIS CONCEPT IS
RELATED TO NON-IMPLANTABLE
SYSTEMS IT SEEMS EXTERNALLY SO I
WON
WONDERING HOW IT CAME ACROSS AND
MAKING SURE IT'S LINKED AND
WHAT'S IT MEAN FOR IMPLANTABLE
DEVICES.
SECOND, HOW ONE MIGHT TAKE INTO
CONSIDERATION THE EXTERNAL
DEVICES THAT MIGHT OR MIGHT NOT
HAVE A REGULATORY BOUNDARY WITH
PLANTABLE DEVICES.
HOW WOULD THAT IMPACT YOUR OVER
ALL RESPONSIBILITY OF THE
MANUFACTURERS.
TAKING THAT INTO CONSIDERATION
ALSO OF WHAT HAPPENS AND
UPGRADING OF THE SYSTEMS GOING
BACK FOR EQUITABLE ACCESS.
IF NEW DEVICES ARE BEING MADE
AND WOULD PEOPLE WHO RESOURCE
THE NEW VERSION WHERE WOULD THEY
GET THAT AND WHERE WOULD BE THE
SOURCE OF FUNDING.
THE FEDERAL GOVERNMENT MAY OR
MAY NOT BE ABLE TO TAKE THAT ON.
I THINK I KNOW WE TALKED ABOUT A
ROLE OR RESPONSIBILITY OF THE
FEDERAL GOVERNMENT WHEN IT
SUPPORTS NEW TECHNOLOGIES TO BE
DEVELOPED TO BASICALLY PUT A SET
ASIDE FUNDING EVERY NEW
TECHNOLOGY THAT COMES LICK THAT
PUTS ASIDE A BANK OF FUNDING FOR
INDIVIDUALS WHO PARTICIPATE
COULD THEN TAP INTO TO BE ABLE
TO GET UPGRADES RENEWALS FOR
THINGS THAT COME WITH TECHNOLOGY
IN OUR MEDICAL CARE SYSTEM WHICH
IS NOT IF YOU DON'T A UNIVERSAL
HEALTH CARE KIND OF SYSTEM AND
ACCESS TO SOMETHING TO BE TAUGHT
THROUGH AT NIH ON A MUCH BIGGER
AND BROADER SCALE THAN EVEN JUST
THE ETHICS PROGRAM.
IT'S IMPORTANT WE BRING THIS
DISCUSSION OUT IN A FORMAL
MANNER.
THANK YOU.
>>LET ME TRY TO TACKLE ALL
THOSE WITHOUT FORGETTING
ANYTHING.
IN TERMS OF INVASIVENESS OR
NON-INVASIVENESS, I APOLOGIZE IF
IT DIDN'T COME ACROSS WE'RE
INTERESTED IN BIONIC AND
ROBOTICS I THINK I MAY HAVE LEFT
THAT DEFINITION VAGUE.
THAT WOULD ENCOMPASS INVASIVE
AND NON-INVASIVE DEVICES.
THERE'S EXAMPLES OF BOTH KINDS
READILY USED IN OUR HEALTH CARE
SYSTEM NOW.
ANYONE THAT WANTS TO DEFINE THAT
CAN DO SO.
AND IN TERM OF POTENTIAL
UPGRADES ALSO TO THOSE RECEIVING
DEVICES YOU GAVE EXAMPLES OF
WHAT POTENTIAL PROJECTS COULD BE
AND BIG TOPICS OF INTEREST I
DON'T THINK THERE'S CLEAR
GUIDANCE ON WHAT TO DO AT THE
MOMENT.
THE QUESTION OF WHETHER OR NOT
PATIENTS GET ACCESS TO NEW
TECHNOLOGY AND HOW THAT'S
FUNDED, I SHARE THAT CONCERN AS
WELL AND I THINK IF THERE WERE
RESEARCH TO SHOW WHAT COULD BE
DONE IN A WAY TO GUIDE THAT
IMPLICATION AS WELL AS HOW MUCH
THAT WOULD COST, WHAT THAT LOOKS
LIKE, I THINK FUNDING
ANNOUNCEMENTS COULD TAKE THAT
INTO ACCOUNT OR ANYONE PLANNING
A RESEARCH GRANT CAN UNDERSTAND
THAT BETTER.
SO WE'RE REALLY HOPING THE
COMMUNITY TAKES THAT STEP BACK
AND ALSO STEP FORWARD AT THE
SAME TIME THAT WHEN THESE
TECHNOLOGIES ARE BEING DEVELOPED
THESE ISSUES ARE ARISING AS
WELL.
THANKS.
>>ZANE AND SUSAN.
>>I HESITATE TO OPEN MY MOUTH
AGAIN BUT ONE OF THE COMMENTS I
MADE IT'S A PRETTY BROAD GROUP
OF STAKEHOLDERS YOU CAN
POTENTIALLY IMPACT.
CAN YOU CONSIDERED A
COLLABORATIVE COMMUNITY AND I
CAN SEND YOU INFORMATION AND
HAVE AN FDA GROUP WITH PRIVATE
COMPANIES AND PRIVATE SECTOR
PARTNERSHIPS TO HASH OUT THESE
TYPES OF ISSUES.
>>THAT WOULD BE GREAT.
ARE THERE OFFICES ALREADY
INCLUDED IN THAT COMMUNITY?
-- ETHICISTS ALREADY INCLUDED?
>>WE HAVE TO BUILD THE
COMMUNITY.
>>GOT IT.
>>WE HAVE TO BUILD THESE
COMMUNITIES ARE NOT TALKING AND
ARE WE GOING TO SUPPORT RESEARCH
THAT COULD BE INTERESTING FOR
POLICY OR ARE WE GOING GET WORK
DONE THAT WILL BECOME POLICY.
SUSAN.
>>I THINK THERE'S ANOTHER AREA
OF BIOETHICS I WOULD LOVE TO SEE
YOU DIVE INTO THE SOCIAL
SCIENCES ASPECT OF TRUST AND
TRUST WITH A HUMAN MACHINE
INTERFACE AND IT GOES BOTH WAYS
THE AMOUNT AND QUALITY AND
NATURE OF THE TRUST OF THE
MACHINE IN THE HUMAN AND OF THE
HUMAN IN THE MACHINE BECAUSE THE
BEST TYPES OF BIO ROBOTICS OFTEN
INVOLVE A.I. AND ENGAGING SOCIAL
SCIENTISTS IN THE BIOETHICS
RELATED TO TRUST.
>>GREAT POINT.
WE THOUGHT ABOUT THAT WITH
EQUITABLE COMMUNITIES AND
BARRIERS TO STIGMA BUT IN THE
GENERAL SENSE I THINK TRUST EN
CAMPUSES THE BASIC WANT OF
SOMEONE USING A DEVICE TO
PARTICIPATE IN A RESEARCH STUDY.
THANK YOU.
THE NIH/NSF PARTNERSHIP IS AN
IMPORTANT COMMUNITY TO REACH OUT
TO AND EXPAND THEIR INVOLVEMENT
IN THESE KINDS OF AREAS.
>>I'M HOPING THEY'LL HELP US.
>>DAVID BACK TO YOU.
>>I'LL ADD MY GRATITUDE TO
COUNCIL MEMBERS FOR YOUR INPUT
ON CONCEPT CLEARANCES.
THANK YOU VERY MUCH.
VERY HELPFUL.
THIS IS WHERE WHY WE HOLD THEM
AND PITCH IT BACK TO YOU BRUCE
BEFORE I CONCLUDE OFFICIALLY CON
INCLUDE THE MEETING WOULD YOU
LIKE TO MAKE CONCLUDING REMARKS?
>>SURE.
THANK YOU ALL.
WE APPRECIATE THE TIME YOU TAKE
AND IT'S ALWAYS AN EXCITING
COUNCIL AND WE'RE HAPPY TO
ENGAGE WITH THIS DIALOGUE.
SEND US YOUR IDEAS, NAMES,
SUGGESTIONS, STORIES.
YOU SAW THE WHOLE GAMUT OF
THINGS COMING UP AND IN FRONT OF
US AND WE'RE TAKING ON.
THIS IS A PARTNERSHIP AND
HELPING GROW AND EXPAND THE SIZE
OF OUR COMMUNITY AND IMPACT.
AND THE RESOURCES OUR COMMUNITY
HAS ACCESS TO.
CONTINUE WORK WITH US ON THAT
AND WE'RE GRATEFUL FOR YOUR
PARTICIPATION AND THANK YOU TO
NIBIB AND THE COUNCIL AND
HOPEFULLY WE'RE ALL STILL AWAKE
AND YOU GET TO HAVE THE FINAL
WORD.
>>THANK YOU SO MUCH FOR AND
THANK YOU EVERYONE.
BEFORE WE ADJOURN OUR COUNCIL
MEMBERS WELL TAKE BASICALLY A
BRIEF FIVE-MINUTE BREAK AND
PLEASE JOIN US IN CLOSED SESSION
THEREAFTER.
IT'S A DIFFERENT ZOOM LINK
HOPEFULLY YOU HAVE SEPARATELY.
I'LL OFFICIALLY ADJOURN THE OPEN
SESSION OF COUNCIL.
I'D LIKE TO THANK OUR VISITORS
FOR ATTENDING THE VIDEOCAST AND
WE HOPE YOU CAN ATTEND THE NEXT
MEETING.
WITH THAT THIS OPEN SESSION OF
THE 61st MEETING OF THE NIBIB
NATIONAL ADVISORY COUNCIL IS
HEREBY ADJOURNED.
THANK YOU, EVERYONE.