ALL RIGHT, GOOD MORNING, GOOD
MORNING.
WELCOME TO DAY TWO.
MY NAME IS TIFFANI BAILEY LASH
AND SERVE AS THE CONFERENCE
CHAIR AND CO-CHAIR AND DIRECTOR
OF THE NIBIB RESEARCH NETWORK.
I AM CHAIRING THIS MEETING ALONG
WITH DR. DHAWAN WHO WOULD NOT BE
HERE TODAY.
I'D LIKE TO RECOGNIZE THE
ORGANIZING COMMITTEE MEMBERS SO
IF YOU'RE HERE, PLEASE STAND.
ALL RIGHT.
WE HAD A VERY FULL DAY
YESTERDAY.
OUR CONFERENCE WAS ONE OF THE
FIRST KEY NOTES FROM OUR NEW NIH
DIRECTOR, MONICA BERTAGNOLLI AND
ENGAGING A DIVERSE GROUP OF
PEOPLE AND THE NIH IS LISTENING
AND POINT-OF-CARE TECHNOLOGIES
DIRECTLY ADDRESSING PEOPLE'S
NEEDS.
THAT'S EXPECT I TOOK AWAY AS
WELL AS DEVELOPING TECHNOLOGIES
FOR INDIVIDUAL'S PEOPLE'S HEALTH
WILL BE THE FUTURE.
WE ALSO HAD A TALK FROM
DR. TRUCE TROMBERG WHO EXPRESSED
THE IMPORTANCE OF PARTNERSHIPS
AND WE ALSO HAD SEVERAL
DISTINGUISHED PANELS ON CLINICAL
PERSPECTIVES AND CHALLENGES,
INDUSTRY PERSPECTIVES,
REGULATORY STANDARDS AND
COMPLIANCE AND GOT TO HEAR ABOUT
RESEARCH INNOVATION AND
TRANSLATION HOT TOPICS AS WELL.
SUCH AS QUANTIFYING HIV VIRAL
LOAD AND FETAL HEALTH
MONITORING.
SO WE ALSO HAD INFORMATION
SHARING REGARDING THE RESOURCES
AND THOSE FEDERAL AND
NON-FEDERAL.
WE WERE ALSO INTRODUCED TO THE
CENTERS YESTERDAY WE HEARD ABOUT
THE INFORMATION WITH THE SIX
CENTERS AS WELL AS HOW THE
PUBLIC ENGAGED AND UTILIZED THE
RESOURCES.
OUR PROCTURN CENTERS ARE
CONSIDERED EXPERTS IN THE
SPECIFIC AREAS AND ARE A
RESOURCE FOR EVERYONE.
THEN WE HAD THE TECHNOLOGY
SHOWCASE.
I WAS BLOWN AWAY BY THE
INNOVATION AND CERTAINLY FEEL
THE FUTURE'S BRIGHT BASED ON
TECHNOLOGIES SHOWN.
WE'RE KICKING OFF DAY TWO BUT WE
DO WANT TO OPEN THE FLOOR AS WE
GET STARTED JUST TO MAYBE SOME
HIGHLIGHTS OR RECAPS FROM
YESTERDAY.
SOME THINGS YOU PERSONALLY WANT
TO TAKE AWAY FROM YESTERDAY'S
KEY TALK.
I WANT TO OPEN THE FLOOR IF
ANYONE HAD ANY THINGS -- NUGGETS
THAT STOOD OUT.
>> GOOD MORNING TO THE MANY
OPPORTUNITIES WITH SEED AND THE
SBIR TO GET HELP IN DEVELOPMENT
ALONG THE PATHWAY OF THE
MENTORING THAT IS POSSIBLE IS
AVAILABLE FOR ANYONE WITH ANY
NIH DOLLARS.
>> ANYONE ELSE?
ANYTHING THAT STOOD OUT FROM
YESTERDAY?
REMEMBER, NIH CAN'T HAVE QUOTE,
UNQUOTE, RECOMMENDATIONS FROM
THE FLOOR BUT WANT TO HEAR WHAT
STOOD OUT FOR YOU ALL AS A
GROUP.
FOR ME, A FEW THINGS I HEARD
FROM THE PANEL YESTERDAY ALL
LOW-RESOURCE SETTINGS SHOULD NOT
BE CREATED EQUALLY.
THAT POINT STOOD WITH ME AS FAR
AS THE DIFFERENT LOCATIONS WE
SUPPORT IN LOW-RESOURCE
SETTINGS.
ANYONE ELSE?
>> THANK YOU FOR THE OPPORTUNITY
TO GIVE FEEDBACK BUT I'LL
HIGHLIGHT THE ONE PARTICULAR
THING, I'M STEVE BERNARD A
CLINICIAN AND CLINICAL TRIALIST
AND THE LIMITING FACTOR IN EVERY
THERAPEUTIC IS THE ROLE OF
PARTICIPANTS IN CLINICAL TRIALS.
IT WAS VERY ENLIGHTENING TO SEE
WITH GOAL DIRECTED PROJECTS WICK
POCKTURNS MAKE SURE THE PATIENT
POPULATION ENGAGED IN THE
RESEARCH PROJECT AND POTENTIALLY
AVAILABLE FOR THE VALIDATION OF
STUDIES TO BRING GOOD IDEAS TO
PRACTICE.
THAT WAS VERY ENLIGHTENING.
>> ANYONE ELSE?
OR THE THOUGHTS OF CONTINUING
PUBLIC HEALTH HAS AN ISSUE.
ANYONE ELSE?
YES, THANK YOU.
>> I'M WITH A COMPANY DEVELOPING
A DEVICE AND INTERESTING TO HEAR
THE STATISTICS DR. MANABE
MENTIONED YESTERDAY 98% TESTED
POSITIVE FOR GONORRHEA WENT ON
TO GET TESTING.
IT'S GRATIFYING TO HEAR IT ENDS
UP IMPACTING THE PATIENTS.
>> ANYONE ELSE?
THERE WAS A TERM USED YESTERDAY
VIRTUAL HOSPITAL.
SO WE ALSO WANT TO HEAR IF THERE
WERE ANY THINGS AS WE MOVE
THROUGHOUT TODAY YOU WOULD LIKE
TO HEAR MORE ABOUT IN THE TALKS
THAT ARE TO BE COVERED?
WOW, WE'RE PRETTY QUIET THIS
MORNING.
I KNOW PUBLIC HEALTH SEEMED TO
COME UP A LOT YESTERDAY.
ANYONE ELSE?
WELL, THE GOOD THINGS TODAY FOR
DAY TWO WE CERTAINLY HAVE A
SESSION ON THE TECHNOLOGY
INNOVATION AND COLLABORATIVE
PARTNERSHIPS THAT DR. MULVANEY
WILL LEAD TODAY.
WE ALSO HAVE A SESSION ON THE
TRANSLATION, VALIDATION AND
BUSINESS MODEL FOR
COMMERCIALIZATION AS WELL AS
ANOTHER SESSION ON LOWER
RESOURCE SETTINGS.
WE'LL ALSO TALK ABOUT DIGITAL
HEALTH TODAY AND THAT WILL BE
LED BY DR. WEIS AND GO INTO
INNOVATION AND TALK ABOUT THE
COMMERCIALIZATION AND CLINICAL
PATIENT PAYER AT THAT TIME.
WE'LL BE LUCKY TO HAVE A KEY
NOTE SPEAKER BY DR. RENEE
WEGRZYN, SHE'S THE ARPA-H
DIRECTOR AND CONTINUE ON WITH
THE RAPID PITCH SESSION AGAIN
AND THE EXHIBIT SESSION FOR OUR
SECOND ROUND OF TECHNOLOGY
SHOWCASE PRESENTERS.
THE TECHNOLOGY SHOWCASE
PRESENTERS FOR TODAY WILL BE
ACCESS BIO WITH A FLU/COVID
COMBO TEST AND A TEST FOR
FUNCTIONAL TESTING AND CODE PCR
PLATFORM FOR PATHOGEN DETECTION
AND MPOD WHICH IS A SIMPLIFIED
DX FULLY INTEGRATED NEXT
GENERATION OTC TESTING PLATFORM.
WE HAVE PROMMINEX AND ULTRA FAST
MOLECULAR DIAGNOSTIC TESTING FOR
INFECTIOUS DISEASES AND PROMPT
DIAGNOSTICS, PORTABLE PCR FOR
LOW COST VIRAL LOAD AND STI
TESTING.
WE ALSO HAVE REISS UNIVERSITY
SHOWING POLYMERIZATION EDIT
BASED FACTORING AND SHOW A
DEVELOPMENT OF MULTI-MOBILE
COLONOSCOPY FOR REAL TIME
CERVICAL CANCER DETECTION AND
HAVE A HIGH-PERFORMANCE OVER THE
COUNTER MULTIPLEX RESPIRATORY
HEALTH SYSTEM.
WE HAVE SCOUT.
A FAST, ACCURATE AND AFFORDABLE
PLATFORM FOR AT HOME DIAGNOSTIC
TESTING.
SO I WANT TO OPEN UP THE FLOOR
ONE LAST TIME IF THERE'S ANY
OTHER THINGS YOU WANT TO HEAR
FROM TODAY DURING OUR SESSION
THAT MAY NOT BE COVERED?
LOOKS LIKE WE'LL HAVE A VERY
EXCITING DAY TODAY.
STARTING TODAY AT 9:30 WE'LL
HAVE SHAWN MULVANEY ON
TECHNOLOGY INNOVATION AND
COLLABORATIVE PARTNERSHIP.
ONE THING I WANT TO MENTION AS
WE START TODAY, THIS IS ACTUALLY
NOT THE FIRST TIME WE'VE HAD A
POINT-OF-CARE MEETING.
WE'VE HAD POINT-OF-CARE MEETINGS
PROBABLY FOR THE LAST FIVE OR
SIX YEARS HOWEVER, IT WAS
STARTED BY OR WE COLLABORATED
WITH THE IEEE ORGANIZATION AND
THE POINT-OF-CARE TECHNOLOGY
CONFERENCES GENERATED IDEAS.
WE HAD A CONFERENCE -- A
SESSION, A WORKING PAPER
AFTERWARDS SO HOPEFULLY WE'LL BE
ABLE TO DO THE SAME THING WITH
THE TECHNOLOGY SHOWCASE
PRESENTERS AND FROM THE
INFORMATION THAT WE COME UP WITH
TODAY DURING OR LAST SESSION
FUTURE OF POINT OF CARE
TECHNOLOGY INNOVATION,
TRANSLATION, COMMERCIALIZATION
AND CLINICAL PATIENT-PAYER
ACCEPTANCES.
AGAIN, WE CAN'T HAVE
RECOMMENDATIONS BUT WANT TO
GATHER INFORMATION FROM YOU GUYS
HERE WHO ARE THE INNOVATORS AND
THE PEOPLE IN THE FIELD DOING
THE COLLABORATIVE AND OUR
REGULATORY PARTNERS TO COME UP
WITH SOME INFORMATION ON HOW WE
NEED TO MOVE FORWARD WITH
POINT-OF-CARE TECHNOLOGIES.
THAT'S ONE OF THE GOALS AS WE
MOVE FORWARD TODAY.
WE DO WANT TO COLLECT THE
INFORMATION TO BE ABLE TO AGAIN,
NOT RECOMMENDATIONS BUT IDEAS
HOW TO MOVE FORWARD WITH
POINT-OF-CARE TECHNOLOGY.
WE'RE IN A VERY SPECIAL MOMENT
AT THIS POINT.
WE HAVE HAD THE PANDEMIC AND
CERTAINLY HAVE MOVED FORWARD IN
THAT SPACE SUCCESSFULLY WITH THE
RADX PROGRAM.
WHAT WE'RE TRYING TO DO NOW IS
FIGURE OUT WHERE THINGS ARE
MOVING IN POINT-OF-CARE
TECHNOLOGIES.
AGAIN, I WANT TO OPEN THE FLOOR
IF ANYONE HAS ANY IDEAS OR
THOUGHTS AS WE CAPTURE THIS
INFORMATION AND MOVE FORWARD
WITH POINT-OF-CARE TECHNOLOGIES.
>> I'M WITH PROMMINEX.
JUST AN ACKNOWLEDGEMENT, I THINK
I SPEAK ON WE HALF OF THE ENTIRE
IBD INDUSTRY IN THINKING THE
GOVERNMENT FOR PARTNERING WITH
THE INNOVATORS TO ADVANCE
TECHNOLOGY.
LOOKING BACK 20 YEARS ALL THE
LAB FOCUS AND DIAGNOSTICS THE
PANDEMIC CATALYZED THE
DECENTRALIZATION OF TESTING FOR
THE PATIENT AND WITHOUT YOU GUYS
AND THE PARTNERSHIP WITH
INDUSTRY WE WOULDN'T BE WHERE WE
ARE TODAY.
WE WOULDN'T HAVE THIS CLEAR OF A
FUTURE SO I REALLY APPRECIATE
WHAT YOU GUYS HAVE DONE AND ARDA
AND RADX TO HELP US OUT.
AND FUNDS FROM THESE EXCITING
NEW TECHNOLOGIES TO BRING
FORWARD SO APPRECIATE IT.
THANK YOU VERY MUCH.
>> THANK YOU.
>> GOOD MORNING.
I THINK ONE THING I'D LIKE TO
HEAR MORE ABOUT AND I HEARD IT
FROM BIG PLAYERS IN THE INDUSTRY
IS HOW YOU MOVE FROM A MODEL
SITUATION LIKE COVID-19
INFECTION INTO SOMETHING THAT IS
MORE REGULAR OR IN PLACE AND MAY
SYNERGIZE SHOULD A PANDEMIC
HAPPEN AGAIN, WHEN IT HAPPENS,
AND THE INVOLVEMENT OF
POINT-OF-CARE TECHNOLOGIES AND
CHRONIC DISEASE MANAGEMENT.
SO THAT WOULD BE AN INTERESTING
TOPIC FOR ME.
I HEAR IT FROM BIG TELEHEALTH
PLATFORMS THAT HAVE DONE VERY
WELL DURING THE PANDEMIC WITH
INFECTIOUS DISEASE NOW THEY'RE
LOOKING IN A WAY TO USE ALL
THEIR INFRASTRUCTURE TO EXPAND
CARE OUTSIDE HOSPITALS FOR
THINGS WE KNOW ARE GOING TO BE
ONGOING.
THAT WOULD BE ONE TOPIC I'D LIKE
TO EXPLORE FURTHER.
>> THANK YOU.
>> ONE THING WE'RE GRAPPLING
WITH, SEVERAL TECHNOLOGIES WE
SUPPORTED DURING THE RADX ERA
NOW IS WHAT'S NEXT AND WHAT DO
WE DO WITH WHAT WE HAVE.
THERE'S SOME SHIFTS AND SOME
SCOPES OF SOME OF THE
TECHNOLOGIES BUT THAT'S
SOMETHING WE'RE GRAPPLING WITH
AS WELL.
>> ONE THING THAT'S VERY MUCH OF
INTEREST TO ME FOR FUTURE
MEETINGS TO HEAR MORE ABOUT IS
HOW CAN WE AS A COMMUNITY THINK
ABOUT MEDICALLY UNDER SERVED
COMMUNITIES WITHIN THE UNITED
STATES.
MY EXPERIENCE AND MY IMPRESSION
IS THAT THERE'S BEEN A LOT MORE
EFFORT TO THINK OF HOW WE TAKE
SYSTEMS APPROACHES TO UNDER
SERVED, INTERNATIONAL SETTINGS.
I THINK SOME OF THE ISSUES ARE
THE SAME BUT A LOT OF THE ISSUES
ARE DIFFERENT.
THEY REQUIRE A DIFFERENT WAY OF
SYSTEMS THINKING AND
INCORPORATING WHO HAS ACCESS TO
CARE ALONGSIDE WHAT IS THE
INFRASTRUCTURE TO SUPPORT CARE.
HELPING THE COMMUNITY FIND A WAY
TO DEEPEN THAT WORK AND DO IT
MORE EFFECTIVELY COULD MAKE A
BIG IMPACT.
>> THANK YOU.
SPEAKING ALONG THOSE LINES, YOU
WOULD BE SURPRISED WHO CONTACTS
ESPECIALLY IN THE POINT-OF-CARE
SPACE AND WE HAVE COLLEAGUES AT
NASA ABOUT GETTING TECHNOLOGIES
AND THINGS TO THE LOWER-RESOURCE
SETTINGS HERE DOMESTICALLY.
ANY THOUGHTS THERE?
WE WELCOME THAT AS WELL AS WE
WORK WITH OUR PARTNERS AND NASA.
>> I'M MIKE DEMPSEY FROM SIM
ASH.
RADX HAS BEEN TALKED ABOUT A LOT
IN THE LAST FEW DAYS AND WITH A
UNIQUE SAID OF CIRCUMSTANCES AND
EVERYONE WAS FOCUSSED ON A
COMMON GOAL AND THERE WAS A
WORLDWIDE CRISIS EVERYONE WAS
REACTING TO AND THE GOVERNMENT
PUT A LOT OF MONEY IN THE
PROGRAM.
SO IF YOU'RE A PRODUCT
DEVELOPMENT PERSON THERE'S THREE
CONSTRAINTS IN EVERY PROBLEM.
THERE'S MONEY, TIME AND SCOPE
AND YOU CAN'T HAVE ALL THREE.
ONE OF THE REASONS RADX WAS
REASONABLY SUCCESSFUL IS BECAUSE
IT WASN'T CONSTRAINED BY MONEY.
MOVING FORWARD, REALITY IS GOING
TO BE WE'RE GOING TO BE
CONSTRAINED BY MONEY.
SO I THINK THE POCTRN NETWORK
CAN THINK HOW TO TAKE THE BEST
OF RADX WITH THE REAL
CONSTRAINT, THE REAL FINANCIAL
CONSTRAINT THAT IS GOING TO BE
PROBABLY DOMINANT IF NOT
PREVALENT OVER THE NEXT COUPLE
YEARS YET STILL GET EXCELLENT
RESULTS AND DON'T KNOW IF THAT'S
SOMETHING WE WANT TO HAVE A
MEETING ABOUT OR THINK ABOUT
STRATEGICALLY BUT FOR THE WORK
TO TRULY BE SUSTAINABLE THAT'S
THE NEXT NUT WE HAVE TO CRACK.
>> TERESA ABRAHAM FROM SAVROS.
ABOUT THE MEANING TO CONTINUE TO
HAVE AT HOME CARE DIAGNOSTICS AT
THE FOREFRONT AND THE PANDEMIC
ALLOWED THAT TO HAPPEN BUT WORRY
WE'LL SLIP BACK TO OLD BAD
HABITS OF NOT THINKING OF
DIAGNOSTICS.
THE OTHER THING I THINK WE
SHOULD THINK ABOUT FOCUSSING ON
IS THERE ARE SEVERAL VALUES OF
DEBT WHEN YOU THINK OF
TECHNOLOGY DEVELOPMENT.
I THINK ONE OF THE ONES THAT
WE'RE DOING VERY WELL IS EARLY
STAGE DERISKING AND THERE'S
ANOTHER VALLEY OF DEATH WHICH IS
ADOPTION.
WE NEED IMPLEMENTATION STUDIES
AND HEALTH ECONOMIC STUDIES
WHICH COMPANIES MAY OR MAY NOT
BE THINKING ABOUT THOSE AHEAD OF
TIME BUT THEY NEED TO BE
HAPPENING EARLY.
IT NEEDS TO BE HAPPENING IN
TANDEM WITH YOUR FDA APPROVAL
PROCESS AND REIMBURSEMENT IS KEY
THE LATTER HALF OF HOW DO I
IMPLEMENT MY TECHNOLOGIES WOULD
BE IMPORTANT AND THAT WOULD BE
GREAT TO SEE POCTRN PERHAPS
FOCUS MORE ON.
>> THANK YOU SO MUCH.
>> CHAD WITH NORTHWESTERN AND
ONE GROUP I HAVEN'T SEEN HERE WE
NEED TO THINK ABOUT HAVE THE
CLINICAL LABORATORIES.
HOW DO WE GET TESTING DONE NOW
IN A LOT OF SETTINGS EVEN
GLOBALLY IN A LOT OF SPACES
PATHOLOGY DEPARTMENTS AND
CENTRAL LABS.
THEY NEED TO THINK HOW WE
PARTNER WITH THEM AND BRING THEM
TO THE TABLE AND PATHOLOGISTS
AND THINK ABOUT WHAT IS TESTING
LIKE IN THE FUTURE.
VERY HIGH LEVEL SOPHISTICATED
COMPLEX TESTING.
THERE'S ALWAYS GOING TO BE A
NEED FOR THAT AND CERTAIN
DIAGNOSTICS AND PATHOLOGY FOR
CANCER DIAGNOSIS AND MOLECULAR
TESTING THAT ARE HIGH LEVEL.
THERE ARE OTHER THINGS THEY DO
THAT ARE FAIRLY MUNDANE TESTING
AND TASKS THAT COULD BE AT THE
POINT-OF-CARE.
JUST THINKING THAT THROUGH
THERE'S A LOT OF ECONOMIC FORCES
WITH HOSPITAL OR COMMERCIAL,
CLINICAL LABS LIKE QUEST AND HOW
WE PARTNER WITH THEM AND HOW DO
THEY THINK ABOUT THIS AND WHAT
ARE THEIR THOUGHTS ABOUT
POINT-OF-CARE TESTING AND MAKE
SURE WE PARTNER WITH THEM AND
THINK ABOUT THEM IN THE EXIST
EQUATION AS WELL.
>> ARE THERE ANY ORGANIZATIONS
OR WAYS WE CAN PARTNER WITH THE
CLINICAL LABORATORIES?
ANY THOUGHTS THERE FROM ANYONE?
>> THERE'S SOME PLACES TO START
TO PARTNER.
>> MATT AT THE MAYO CLINIC RUNS
THE LAB MAKES THE POINT THAT
FIVE YEARS AGO IF YOU WANTED TO
THE THE PATIENT'S TEST RESULT
THEY'D SAY NO AND NOW THEY WANT
TO INTEGRATE THAT AND OTHERS
MADE THE SAME POINT AND ECHO THE
OTHER COMMENT MADE ONE OF THE
THINGS WE SPEND MORE TIME
DISCUSSING IS WHERE DO WE FIND
SOMEONE AS AN EXPERT IN
REIMBURSEMENT TO HELP NAVIGATE
THAT.
THAT'S A PROBLEM WE HAVE.
WHEREIN THING WE'RE TRYING TO DO
IS PARTNER THE PHYSICIAN WITH
THE CLINOLOGIST AND WE BELIEVE
THE NEED IS WHAT SHOULD DRIVE
THE TECHNOLOGY.
IS THERE ANY THOUGHTS WITH
REGARDS TO BRINGING MORE
CLINICIANS AND ENGINEERS
TOGETHER TO HELP SOLVE PROBLEMS?
THAT'S SOMETHING WE'RE ALSO
LOOKING AT AS WELL.
OKAY.
ANY OTHER THOUGHTS FROM
YESTERDAY ANYONE WOULD LIKE IT
SHARE.
>> PROXINEX AGAIN.
ONE THING THAT MAY BE USEFUL
GOING FORWARD IS GETTING
ADDITIONAL REPRESENTATION FROM
GATES, WHO AND THERE'S TALK THAT
WITH PARALLEL EFFORTS INDUSTRY
CAN PARTNER NOT ONLY WITH THE
U.S. GOVERNMENT AGENCIES BUT
ALSO NGOs.
AND DEVELOP PRODUCTS
SPECIFICALLY FOR LMIC AND PLAY A
ROLE HERE IN THE U.S.
>> WE CERTAINLY DO.
THANK YOU FOR THAT COMMENT.
WE CERTAINLY WORK WITH OUR
PARTNERS ESPECIALLY WITH THE
GATES FOUNDATION AND OTHERS IN
OUR INITIATIVE.
HOPEFULLY YOU GUYS WILL CHECK
OUT WE HAVE DIFFERENT CHALLENGES
WITH OUR PARTNER AGENCIES THAT
ARE OUT NOW.
ANY OTHER THOUGHTS?
>> YESTERDAY WHEN I SAW THE
PRESENTATIONS FROM THE DIFFERENT
CENTERS SOMETHING I NOTICED IS
THAT THE TECHNOLOGY WASN'T
ALWAYS AT THE TRADITIONAL
POINT-OF-CARE SETTING.
IT WAS ALSO USED IN HOSPITALS IN
EMERGENCY ROOMS AND SUPPORTING
TELEHEALTH.
I THINK JUST THINKING OUTSIDE OF
THE TRADITIONAL POINT-OF-CARE I
DON'T KNOW IF IT'S THE POINT OF
NEED OR YOUR TECHNOLOGY CAN BE
APPLIED TO DIFFERENT SETTINGS
AND IT KIND OF OPEN UP YOUR MIND
WHEN YOU'RE DEVELOPING AND
THINKING ABOUT DIFFERENT USE
CASES AND WHERE YOU MIGHT MAKE
THE GREATEST IMPACT.
>> THANK YOU.
>> JILL TAYLOR.
CDC IS NOT HERE AND I FIND THAT
REALLY SAD.
ONE OF THE RECOMMENDATIONS WE'VE
JUST MADE TO THE DIRECTOR IS TO
MORE CLOSELY WITH PRIVATE
INDUSTRY.
I BROUGHT UP PUBLIC HEALTH
YESTERDAY.
WHAT WE'RE TALKING ABOUT TODAY
IS -- THIS IS GOING TO CHANGE
PUBLIC HEALTH BUT WHILE THERE'S
BEEN A LOT OF CRITICISM OF CDC,
JUST OF JUSTIFIED, THEY ARE
MOVING FORWARD.
THEY CREATED A NEW CENTER FOR
LABORATORY SYSTEMS AND RESPONSE
AND THEY'RE THINKING IN A
SYSTEMS TYPE WAY AND THINK THEY
NEED TO BE PART OF THE
CONVERSATION AND I HAVE
MENTIONED THIS TO BRUCE TROMBERG
AND HAS TALKED ABOUT PARTNERSHIP
AND INDUSTRY FELLOWS WORKING AT
CDC AND THE REVERSE.
I'M SOUND LIKE A BROKEN RECORD
BUT PLEASE KEEP PUBLIC HEALTH IN
THE LOOP.
>> DO YOU HAPPEN TO HAVE ANY
THOUGHTS OF KEEPING PUBLIC
HEALTH IN THE LOOP ESPECIALLY
WHEN IT COMES TO POINT-OF-CARE
TECHNOLOGY?
>> ENGAGING PUBLIC HEALTH
READERS IN THE DESIGN OF TESTS.
THE TESTS THEY WOULD USE IN
POP-UP SITES, IN MOBILE VANS.
THE PUBLIC HEALTH NEEDS FOR STIs
CLEARLY.
ONE OF OUR LABS IN A VERY RURAL
STATE WORKS IN TRIBAL
COMMUNITIES.
THERE'S A GREAT DEAL OF INTEREST
IN DOING BETTER IN THOSE
COMMUNITY.
HAVING A PUBLIC HEALTH VOICE AT
THE TABLE WITH THE DESIGN AND
THE PATHOGENS WOULD HELP US A
LOT.
CLEARLY A LOT OF THE SUPPORT FOR
THAT IS GOING TO COME FROM
FEDERAL GOVERNMENTS BUT YOU
KNOW, THINK ABOUT THE ELC GRANTS
WHICH ARE A MAJOR SOURCE OF
FUNDING FOR PUBLIC HEALTH LABS
AND INFLUENCING CDC TO FUND
THESE SORT OF DEVICES.
I JUST THINK IT'S A PARTNER
THAT'S MISSING.
>> THANK YOU.
>> GOOD MORNING.
I'M FROM THE ACADEMIC SIDE
UNIVERSITY OF NOTRE DAME.
WHEN I THINK OF POINT-OF-CARE I
IMAGINE SOMEONE AT HOME HAVING
CARE THERE AND IMAGINING THEY'LL
BE PART OF THE CONVERSATION BUT
I SEE DIVERSITY AND I WOULD LIKE
TO SEE IF THERE'S ANY
CONVERSATION WITH NIA OR ANY
OTHER ENTITIES HOW TO APPLY THE
TECHNOLOGY HERE TO OLDER ADULTS.
>> THANK YOU.
ONE THING WE GRAPPLE AS AN
INSTITUTE IS THE DIFFERENT
FUNDING MECHANISMS.
WE TALKED ABOUT THAT YESTERDAY A
BIT.
WE CERTAINLY HAVE OUR
TRADITIONAL RO1s, WE HAVE SPIRs,
WE ALSO HEARD FROM OUR SEED
OFFICE.
WE HAVE POCTRN AND OTHER
INITIATIVES.
FOR OUR COMMUNITY WE TRY SBIRs
AND ACADEMIC INDUSTRIAL
PARTNERSHIPS.
I'M CURIOUS IF THERE'S ANY
THOUGHTS ABOUT DIFFERENT TYPES
OR IF THERE ARE ANY AREAS THAT
YOU FEEL ARE UNMISSED IN OUR
COMMUNITY THAT COULD BE TAPPED
INTO.
>> HI.
FOR THE LAST FEW YEARS I'VE BEEN
DOING RESEARCH IN ADHERENCE AND
MEDICATION ADHERENCE I KNOW IS A
BIG PROBLEM IN CLINICS.
SO AFTER HEARING THE GREAT NEED
ABOUT WORKING WITH THE PUBLIC
HEALTH I THINK THAT'S GOING TO
BE REALLY CRITICAL BECAUSE WE
CAN MAKE TESTS AND HOW DO WE GET
PEOPLE TO USE THEM?
SO I THINK IT'S A REALLY
CRITICAL THING TO THINK ABOUT
AND HOW COMPANIES OR POCTRN CAN
WORK WITH THE PUBLIC HEALTH
BECAUSE THEY'RE OUT THERE AND
THEY'D BE THE ONES TO TRY AND
GET EDUCATION TO THOSE PEOPLE
AND STRESS THAT IT'S IMPORTANT
SO THERE'S SOMETHING TO BE SAID
ABOUT ACCESS AND ALSO ONCE THE
ACCESS IS THERE TO EDUCATE SO
THESE PEOPLE DON'T HAVE STIGMAS
AND WANT TO USE IT.
THANK YOU.
>> GOOD MORNING.
KELLY MAYO FROM ARDIN MEDICAL.
I'VE APPRECIATED THE LAST DAY
AND LOVED THE COMMENT ABOUT HOW
THE NEED SHOULD DRIVE THE
TECHNOLOGY AND I THINK THAT YOUR
INSTITUTE DOES A FANTASTIC JOB
OF PAIRING THE CLINICIAN WITH
OUR INNOVATORS AND REALLY TRYING
TO UNDERSTAND THAT CLINICAL
NEED.
SOMETHING THAT OUR TEAM HAS
FOUND REALLY VALUABLE AS WELL AS
IS THE VOICE OF THE PATIENT TOO.
AND I REALLY RESPECT THE WORK
COMING OUT OF DR. WILKENS LAB AT
VANDERBILT WHERE SHE'S PIONEERED
A METHOD OF COMMUNITY ENGAGEMENT
TO BRING COMMUNITY PARTNERSHIPS
INTO THE VOICE OF INNOVATION AT
THE EARLY STAGES OF R&D AND ONE
THING WE'VE TRIED TO DO IS BRING
THAT INTO THE PRODUCT
DEVELOPMENT LIFE CYCLE AS WELL
BECAUSE AS A PRIVATE COMPANY WE
HAVE TO BE VERY CAUTIOUS ABOUT
HOW WE BUILD TRUSTED
RELATIONSHIPS ESPECIALLY WITH
UNDER SERVED COMMUNITIES WE'RE
TRYING TO SERVE.
AND SO THINKING PUTTING MY
INNOVATOR HAT ON, ONE THING THAT
WOULD BE LOVELY WOULD BE TO
MAYBE SEE SOME SMALL PILOT
GRANTS THAT ALLOW US TO USE
EXISTING RESOURCES FROM
NETWORKS -- I FORGET THE ACRONYM
I THINK IT MAY BE PART OF PCORI
BUT YOU HAVE THESE INSTITUTES
AND CENTERS THAT ALREADY
SPECIALIZE IN COMMUNITY
ENGAGEMENT MODELS.
SO IT WOULD BE REALLY NEED TO
SEE SMALL PILOT GRANTS
INNOVATORS CAN USE TO WORK WITH
EXPERTS IN ENGAGEMENT TO
APPROPRIATELY ENGAGE THE PATIENT
VOICE IN PRODUCT DEVELOPMENT AND
INNOVATION LIFE CYCLES.
THAT WOULD HELP THAT BECOME
INTENTIONAL AND LESS BURDENSOME
ON THE COMPANY TRYING TO SEEK
OUT THOSE PARTNERSHIPS.
>> THANK YOU.
THAT'S A GREAT IDEA.
>> THANK YOU SO MUCH.
>> SORRY, I DIDN'T THINK THE MIC
WAS WORKING.
THAT WAS EVERYTHING I WAS JUST
GOING TO SAY BASICALLY.
IT'S NICE TO SEE IN THE GRANT
THERE'S COMMUNITY IMPLEMENTATION
PLANS BUT AGAIN NOR PATIENT
ENGAGEMENT PIECE WE HAVE TO BE
THINKING ABOUT PATIENT AND
PUBLIC INVOLVEMENT, PATIENT
ENGAGEMENT AND PATIENT
EXPERIENCE DATA THROUGHOUT THIS
ESPECIALLY POINT-OF-CARE
DIAGNOSTIC DESIGN.
WE NEED TO BE INCLUDING THOSE
PLANS.
WE LIKE TO CALL THEM PATIENT
ENGAGEMENT PLANS LIKE YOU HAVE
COMMUNITY IMPLEMENTATION PLANS.
NOT JUST STUDYING THE SCIENCE
AND THE ACCESS AND IMPROVING
EDUCATION.
OF COURSE THINKING HEALTH EQUITY
AND NUMERACY AND INCORPORATING
ALL OF THAT BUT THE FRAMING WILL
HELP YOU GET TO THE PATIENT
PREF
PREFERENCES AND USE AND ADHERE
TO AND THINKING ABOUT THE
PATIENT ENGAGEMENT FROM THE
BEGINNING AND PUBLIC INVOLVEMENT
COMPLETELY FROM THE BEGINNING.
THE PATIENTS NEED TO BE AT THE
TABLE AND NEED TO HAVE THE
REPRESENTATIVENESS.
WE HAVE HETEROGENEITY IN THE
PREFERENCES AND THAT NEEDS TO BE
CONSIDERED IF YOU WANT TO GET
YOUR PRODUCT USED.
>> THANK YOU.
SO ONE OTHER AREA WE'RE
INTERESTED IN AS WELL IS
ENGAGING OUR NURSING COMMUNITY.
DOES ANYONE HAVE ANY THOUGHTS
HOW TO ENGAGE OUR NURSING
COMMUNITY WITH POINT-OF-CARE
TECHNOLOGY COMMUNITY?
>> WITH NURSING IT'S IMPORTANT
NO THINK OF WORK FLOW.
POST COVID-19 THE BURDEN ON
NURSES HAVE BEEN INCREDIBLE.
I HAVE PEOPLE WHO HAVE QUIT
WORKING BECAUSE THEY BURNED OUT
AFTER COVID.
IT'S IMPORTANT TO THINK HOW IT
WOULD IMPROVE THEIR EFFICIENCY
AND WORK FLOW WITHOUT ADDING
BURDEN.
YOU'RE GOING TO HAVE TO TAKE
SOMETHING AWAY IF YOU'RE GOING
TO ADD TESTING IN THERE AND I
FEEL THE SAME WITH PHARMACIES.
THEY'VE BEEN TOUTED AS A
POTENTIAL WAY TO GET TESTING
UNDERWAY IN A CONSUMABLE IN A
KIOSK AND WHO MAINTAINS IT WORKS
WELL AND MAINTAINED FOR THAT
TIME YOU CAN'T KEEP PILING MORE
THINGS IN A PLACE.
FOR ME THAT'S GOING TO REQUIRE
SOME IMPLEMENTATION SCIENCE
AROUND THE WORK FLOW AND HOW YOU
CAN TAKE SOMETHING AWAY WHILE
YOU'RE ADDING THAT.
>> THANK YOU.
ANY OTHER THOUGHTS THERE?
THANK YOU FOR BRINGING UP
INFORMATION ABOUT REIMBURSEMENT
AGAIN.
IT'S FUNNY, WE HAVE MISSIONS
WITHIN AGENCIES BUT WORKING
TOGETHER HELPS MOVE THE NEEDLE
FURTHER.
ANY OTHER THOUGHTS OR THINGS
YOU'D LIKE TO SEE AS WE MOVE
FORWARD DURING TODAY'S TALKS OR
IN THE FUTURE?
WE'LL GET READY FOR THE NEXT
PANEL IN THE NEXT FEW MINUTES ON
CHAIRED BY SHAWN MULVANEY ON
POINT-OF-CARE TECHNOLOGIES AND
INNOVATION AND COLLABORATIVE
PARTNERSHIPS AND GET THAT PANEL
GOING NOW.
THANK YOU.
GOOD MORNING, EVERYONE.
.
>> HOW'S EVERYBODY'S DOING
TODAY?
WELCOME TO THE CONFERENCE.
IT'S BEEN A DYNAMIC SET OF
CONVERSATIONS AND THE PANELS YOU
SAW THROUGH YESTERDAY AND
CONTINUE THROUGH TODAY WILL HAVE
OVERLAPPING THEMES.
THE THEME OF TODAY WILL BE
TECHNOLOGY BUT LET'S START BY
GETTING TO KNOW EACH OTHER A
LITTLE BIT.
MY NAME IS SHAWN MULVANEY.
I'M A PROGRAM OFFICER AT NIBIB
AND WORK ON THE BIO SENSORS
PORTFOLIO.
EARLIER STAGE THAN SOME OF THE
TECHNOLOGIES YOU'LL SEE OUT IN
THE FLOOR TODAY OR MAYBE WORKING
ON BUT EXCITING STUFF AT THE
FRONT END OF THIS TYPE OF WORK.
WE WORKED FROM GENOMIC THROUGH
THE ANTIGENS AND TRIED TO BRING
THINGS TO BEAR AGAINST
DIAGNOSTIC DETECTION.
VERY EXCITING STUFF.
PRIOR TO COMING TO NIH I SPENT
TWO DECADES AT THE NAVY WORKING
ON BIO SENSORS SO I WAS BUILDING
DEVICES TO PUT IN THE HANDS OF
WAR FIGHTERS OR PEOPLE THAT ARE
FIRST RESPONDERS AND IS THAT
WHITE POWDER SOMETHING YOU'RE
INTERESTED IN OR HOW CAN WE
IMPROVE A LATERAL FLOW.
THAT HAS INFORMED A LOT OF WHAT
I'VE BEEN ABLE TO DO WITH MY
TEAMS WITHIN RADX AND MY
PORTFOLIO AND WHY I'M EXCITED TO
HAVE THIS DISTINGUISHED SET OF
COLLEAGUES WITH US TO DISCUSS
THIS TODAY.
TODAY WE'RE TALKING ABOUT
TECHNOLOGY INNOVATION,
COLLABORATION AND PARTNERSHIP SO
THE GOAL OF TODAY'S SESSION IS
TO THINK ABOUT YOUR ENTIRE
DEVELOPMENT FROM YOUR IDEA ALL
THE WAY TO PUTTING THE PRODUCT
IN SOMEONE'S HAND.
THEY NEED TO PURCHASE THAT
PRODUCT AND USE THAT PRODUCT.
WE'RE GOING TO TALK ABOUT
VARIOUS ASPECTS OF THAT.
WHILE WE UNDERSTAND THERE'S NO
CARBON COPY BETWEEN ANY TWO OF
YOUR DEVELOPMENTS, THERE'S
DIFFERENT THEMES AND THIS
DISTINGUISHED SET OF PANELISTS
HAVE TRANSVERSED SEVERAL OF
THOSE ON MULTIPLE OCCASIONS
EACH.
I'M VERY EXCITED TO DO THAT.
I'M GOING LEAD THE CONVERSATION
STARTING LIKE WILBUR DID
YESTERDAY.
WE'LL HAVE A CONVERSATION
AMONGST THE FOUR OF US AND WILL
TIME AND I'D LIKE WITH TO YOU
ENGAGE WITH OUR PANELISTS AS
WELL AND SAVE FIVE OR 10 MINUTES
AT THE END SO PREPARE YOUR
QUESTIONS AS WE GO ALONG.
LET ME HAVE EACH OF YOU
INTRODUCE YOURSELVES, WHERE YOU
ARE IN THE DIAGNOSTIC UNIVERSE
AND START WITH YOU STEPHANIE,
PLEASE.
IS IS
>> GOOD MORNING.
I'M STEPHANIE CALDERWOOD A
SCIENCE AND TECHNOLOGY MANAGER
AND CURRENTLY THE ACTING TEAM
LEAD FOR THE MEDICAL DIAGNOSTICS
TEAM AND DIRECTOR.
I'VE BEEN AT DETRA A LITTLE OVER
FOUR YEARS IN THE CHEMICAL, BIO
CHEMICAL DIAGNOSTICS SPACE AND
SIX YEARS PRIOR WORKING ON
COOPERATIVE BIOLOGICAL
ENGAGEMENT PROGRAM AND DOD EBOLA
OUTBREAK RESPONSE OUTBREAKS ON
THE AFRICAN CONTINENT.
HAPPY TO BE HERE TODAY AND TALK
TO YOU ALL.
>> TERESA.
>> THANK YOU, SHAWN.
IT'S A PLEASURE TO BE ONE YOU,
STEPHANIE AND ERIC.
I HAVE A BIT OF AN UNUSUAL
BACKGROUND.
TRADITIONALLY I TRAIN SCIENTISTS
ONE AN ACADEMIC POSTDOC AND CAME
AS A TRIPLE IS FELLOW AND THE
FELLOWSHIP IS ABOUT TEACHING
SCIENTISTS HOW POLICY IS MADE
AND HAVING SCIENTIST INFORM
POLICY MAKING AND WE HEARD FROM
DR. BERTAGNOLLI YESTERDAY OUR
JOB IS NOT DONE UNTIL
TECHNOLOGIES REACH INDIVIDUALS
SO THAT'S WHAT I'VE BEEN DOING
THE LAST FEW YEARS.
WE WERE DEVELOPING A
POINT-OF-CARE SINGLE USE PCR
TEST AND DEVELOPED A GONORRHEA
AND OTHER TESTS AND SUPPORTED
RADX ON THE PLATFORM AND WAS
ABLE TO SECURE FUND FROM BARDA
TO MULTIPLEX FLU A AND B ON THE
PLATFORM.
AND YOU COLLECT DIFFERENT HATS
AND BY THE TIME I LEFT I STOOD
UP THE MEDICAL AFFAIR DIVISION
AS WELL AS GOVERNMENT AFFAIRS.
I WAS DOING LOBBYING ON CAPITOL
HILL TO EDUCATE LEGISLATORS ON
THE IMPORTANCE OF POINT-OF-CARE
AS WELL AS AT HOME DIAGNOSTICS.
STILL CONTINUE TO RAISE
NON-DILUTED CAPITAL AND NOW I'M
ONE A YOUNG COMPANY.
OVER THE LAST TWO YEARS THE CEO
AND FOUNDER HAVE BEEN ACQUIRING
AND FOSTERING SEVERAL KEY
TECHNOLOGIES, WHICH IN MY
OPINION ARE CRITICAL TO
GREATNESS TO PUSH DIAGNOSTIC
TECHNOLOGIES INTO THE HOME.
ONE OF THE THINGS WE HAVE DONE
IS ACQUIRED A COMPANY CALLED
FLUXO TRONICS A GATES FOUNDATION
FUNDED COMPANY AND THAT CHANGED
THE WAY WE THINK ABOUT
MANUFACTURING.
SAVROS HAS BEEN A FUN RIDE AND
WE DO WHAT NEEDS TO BE DONE AND
MY ROLE SPREAD THE GAMUT OF
SPREADING NON DILUTE OF CAPITAL
TO FUNDING AND GETTING
DIAGNOSTICS INTO DECENTRALIZED
HEALTH CARE SETTINGS SO I LOOK
FORWARD TO THE CONVERSATION.
>> MY BACKGROUND IS IN IBD
DEVELOPMENT AND I RETIRED IN
2018 AND HAPPILY PLANNING MY
TRAVELS FOR ALL OF 2020 AND ALL
CAME CRASHING DOWN IN MARCH OF
2020.
SO I JOINED THE NIH RADX PROGRAM
AND AT THAT TIME I WAS TOLD THAT
IT WOULD BE ABOUT 20 HOURS
ROUGHLY A WEEK FOR ABOUT FOUR
MONTHS.
SO IT FELLS LIKE GETTING ON A
BOAT TO GILLIGAN ISLAND AND
THREE AND A HALF YEARS LATER I'M
STILL ON THE ISLAND.
BUT IT HAS BEEN A FUN RIDE.
I STARTED AS A TEAM LEAD IN THE
RADX PROGRAM AND IN JANUARY 2021
I STARTED LEADING THE VARIANT
TASK FORCE OF COVID AT RADX AND
THEN IN SEPTEMBER OF 2021 WITH A
NUMBER OF RADX COLLEAGUES WE
DEVELOPED A FRAMEWORK FOR THE
ITAB PROGRAM WITH THE IDEA OF A
SPECIFIC PROGRAM TO BRING IN
HIGH QUALITY TESTS OVER THE
COUNTER, POINT-OF-CARE TESTS IN
THE U.S. IN COLLABORATION WITH
THE FDA.
AS BRUCE POINTED OUT YESTERDAY
IT'S BEEN A SUCCESSFUL PROGRAM.
WE HAVE 16 EUA, TWO IN COVID AND
ONE IN COMBO AND ONE IN MONKEY
POX SO IT'S NOT JUST COVID.
WE'RE NOW BRANCHING TO OTHER
AREAS AS WELL.
BRUCE MENTIONED YESTERDAY WE
HAVE AN HCV PROGRAM STARTLING
AND THAT'S AN AGGRESSIVE
PROGRAM.
WE'RE AIMING TO DO A DE NOVO
FROM THE BEGINNING INCLUDING THE
CLINICAL TRIAL AND CLEARANCE IN
NINE MONTHS.
THIS IS RECORD SPEED.
OUR RECORD OF EUA CLEARING IN
THE ITAB PROGRAM WAS 57 DAYS
FROM THE FIRST DAY WE MET WITH
THE COMPANY TO GETTING EUA
CLEARANCE.
WE KNOW HOW TO DO THIS AND HAVE
DONE THIS BEFORE.
I'VE BEEN SCIENTIFIC LEAD AND
THE CLINICAL TRIAL P.I. AND I AM
THE PERSON THAT TALKED TO THE
FDA WITH RESPECT TO ITAB.
>> EXCELLENT.
LET'S START THE JOURNEY.
WE'LL START OUR MYTHICAL JOURNEY
FROM THE IDEA.
WHAT IS THE IDEA AND WHERE DOES
THE IDEA START?
SO STEPHANIE, I'M EXCITED TO
HAVE YOU HERE.
A DOD PERSPECTIVE IN AN HHS
WORLD.
LET'S TALK ABOUT THE IDEA HOW DO
YOU AND DITRA COME UP WITH FRESH
EXCITING SCIENCE AND REAL ASKS
FROM YOUR COMMUNITY.
CAN YOU DISCUSS HOW YOU COME UP
WIN YOUR IDEAS PRIOR TO GOING TO
THESE DEVELOPERS TO ASK THEM
WHAT THEY HAVE FOR YOU?
>> ABSOLUTELY.
YOU'RE CORRECT.
TO SCENE SET A LITTLE BIT, MANY
FOLKS MAY NOT BE SUPER FAMILIAR
WITH THE DOD STRUCTURE OR WHERE
OUR AGENCY SITS WITHIN IT.
SO THE JOINT SCIENCE AND
TECHNOLOGY OFFICE WITH SITS
WITHIN DINDRA IS WHERE I WORK
AND WE'RE PART OF THE CHEM BIO
DEFENSE PROGRAM AND REQUIRE THE
JOINT REQUIREMENT OFFICE WORKING
WITH SERVICE REPS AND DEVELOPS
REQUIREMENTS EACH SERVICE NEEDS
TO MEET IN THE CHEMICAL AND
BIOLOGICAL SPACE.
WE DON'T DEAL WITH RAD OR NUKE
OR PUBLIC HEALTH.
WE'RE FOCUSSED ON CHEMICAL AND
BIOLOGICAL WARFARE AGENTS AND I
SIT IN EARLY S&T TECHNOLOGY AND
1 THROUGH 4ISH SOMETIMES THROUGH
5 AND THE JOINT PROGRAM
EXECUTIVE OFFICE OUR ADVANCED
DEVELOPER AND THEY TAKE THE
TECHNOLOGIES THAT HAVE PROVEN
SUCCESSFUL FROM US AT A TLR4
THROUGH ADVANCED TECHNOLOGY
DEVELOPMENT TEST AND EVALUATION
AND THEN PROCUREMENT.
SO PART OF THE EFFORTS THAT WE
FUND AND THE IDEAS WE HAVE COME
FROM THAT JOINT REQUIREMENTS
OFFICE.
AGAIN, THEY ARE TALKING TO THE
SERVICE REPS CONSTANTLY.
THEY'RE GETTING DOCUMENTS FROM
ALL THE SERVICES OUTLINING GAPS
OF CAPABILITY THAT TO BE
ADDRESSED IN THE CHEM BIO SPACE
AND THE GRO THEN WRITES
REQUIREMENTS AND SENDS THEM TO
US IN WHAT WE NEED.
FOR MEDICAL DIAGNOSTICS IT'S
USUALLY INCREDIBLY BROAD.
WE NEED GREATER CHEMICAL HISTORY
WHICH IS A BROAD SCOPE.
WE START RELYING ON OUR IN-HOUSE
TECHNOLOGY AND SCIENCE AND
TECHNOLOGY MANAGERS LIKE MYSELF
AND SUBJECT MATTER EXPERTS ON
THE PRIVATE SIDE TO START BRAIN
STORMING WHAT CURRENTLY EXISTS.
HOW CAN WE MAKE CURRENT
TECHNOLOGY BETTER MORE REFINED
AND SPECIFIC AND LIGHTER,
FASTER, OR IS THERE NOT A
TECHNOLOGY THAT EXISTS YET THAT
WOE WE COULD DEVELOP AND THEN
GET WHAT WE THINK IS A GOOD IDEA
AND PUT OUT REQUEST FOR AGENCY
OR BROAD AGENCY ANNOUNCEMENT FOR
INDUSTRY OR ACADEMIA AND THE
PEOPLE WHO ARE REALLY DOING THIS
WORK IN A LAB OR IN THE FIELD
EVERY DAY TO TELL US WHAT THEIR
WORKING ON AND WHAT IS POSSIBLE
AND MAYBE ALREADY STARTED.
THAT'S FROM THE REQUIREMENT
SIDE.
THOSE ARE THE HARD ASKS WE HAVE
TO MEET BUT THE OTHER PART OF
THAT IS WE ARE THE S&T ARM AND
WITH THAT COMES THE CHARGE TO
LOCK AT NEW, NOVEL INNOVATIVE
SCIENCE AND PUSH THE BOUNDS OF
THE POSSIBLE AND THROUGH THAT,
THAT'S REALLY WHERE WE SIT IN A
ROOM AND GET TOGETHER AND GET TO
BE NERDY AND WE GET TO TAKE A
STEP BACK FROM DOD WAR FIGHTER
READINESS AND LOOK AT WOULDN'T
IT BE GREAT IF -- THAT'S THE
QUESTION I ALWAYS LOVE TO ASK.
I THINK COVID WAS A REALLY
EXCITING TIME FROM THE SCIENCE
PERSPECTIVE TO GET TO ASK THOSE
QUESTIONS AND THAT'S REALLY
SHAPED SOME OF OUR CURRENT
INVESTMENT.
QUESTIONS LIKE WHAT IF WE COULD
DETERMINE PRE-SYMPTOMATIC
INFECTION OR DEVELOP AN ASSAY OR
TEST FASTER.
WHAT WOULD THAT PIPELINE LOOK
LIKE?
THINGS LIKE THAT.
THE NEW NOVEL INNOVATIVE PIECE
IS WHAT ARE WE SEEING IN
LITERATURE?
WHAT ARE WE SEEING IN ACADEMIA
OR PRIVATE INDUSTRY THAT MAY BE
INTERESTING AND WHAT INTEREST
THE CRAZY OFF THE WALL IDEAS IN
BRAIN STORMING SESSIONS
INTERNALLY THAT ARE COOL AND GET
US TO A PLACE WE AREN'T YET BUT
NEED TO BE.
>> AND CONCEPT OVER WHAT TIME
FRAME YOU'RE LOOKING AT THINGS
THAT MAYBE AREN'T ACUTE BUT WHAT
IS YOUR PLANNING, FIVE YEARS,
TEN YEARS?
USUALLY FIVE YEARS.
AND OUR FISCAL YEAR IS 1 OCTOBER
TO 31 SEPTEMBER.
>> ERIK, YOUR PHONE RINGS AND
IT'S A NEW PROBLEM, HEPATITIS C
OR HIV VIRAL LOAD OR SOMETHING
WHAT ARE YOU LEARNING AND IF
IT'S MARKET ANALYSIS CAN YOU
SHARE WITH DEVELOPERS IDEAS HOW
TO GET ON YOUR RADAR BEFORE YOU
CALL THEM?
>> WE'VE BEEN LUCKY AS FAR AS
PROGRAMS ARE CONCERNED.
TO ME THE MOST IMPORTANT PART
WHEN YOU CONSIDER ANY PROJECT IS
IS YOU HAVE TO HAVE ESPECIALLY
IN DIAGNOSTIC A CLINICAL UTILITY
AND MEDICAL NEEDS.
I'VE SEEN NICE, FANCY
TECHNOLOGIES BUT THEY HAVE ARE
NO IDEA HOW TO APPLY IT.
HHS AND NIH COME TO US AND SAY,
OKAY, WE NEED TO BRING IN COVID
TESTS OVER THE COUNTER, ALL OF
THESE TESTS IN THE U.S. AND WE
WENT AND DID IT.
I THINK OUT OF THE 7 BILLION
TESTS THAT BROUGHT INTO THE
COUNTRY, ABOUT HALF OF THEM WAS
BROUGHT IN THROUGH THE ITAB
PROJECT.
THE NEXT PROJECT WAS THE COMBO.
COVID/FLU COMBO WHICH ALSO HAS
THE UTILITY AND MEDICAL NEED AND
THEN TURNS AROUND M POX AND WE
PUT A TEAM TOGETHER IN RESPONSE
TO M POX.
EVERY PROJECT WE HAVE DONE SO
FAR HAVE IMMEDIATE NEEDS.
AS FAR AS HOW TO ENGAGE ITAB AND
FACILITATION -- I CANNOT SAY
THIS MORE WHICH IS IF YOU READ
OUR OPEN SOLICITATION EVERY
SINGLE WORD COUNTS.
WE SPENT WEEKS WORKING WITH THE
CDC AND FDA DOING AND FINE
TUNING EVERY SINGLE WORD IN THE
OPEN LEGISLATION.
YOU HAVE TO READ IT.
IT CONTAINS VERY IMPORTANT
INFORMATION HOW TO APPLY TO IT
AND A LOT OF COMPANIES DON'T
KNOW THAT.
IT HAS ALL THE INFORMATION IN
IT.
YOU HAVE TO DO IT AND THE OTHER
REASON ITAB IS SUCCESSFUL AND IS
DIFFERENT FROM ALL THE NIH
PROJECTS AND RADX IS WE ARE NOT
A RESEARCH PROGRAM.
OUR GOAL IS TO IMPLEMENT ASSAYS
THAT HAVE BEEN DESIGN, DESIGN
LOCKED AND READY TO GO READY FOR
PRIME TIME.
>> SAVROS IS AN INTERESTING
COMPANY AND TALK ABOUT HOW THEY
PLAY INTO NEW IDEAS.
ARE YOU PUTTING THE LEGO BLOCKS
TOGETHER AND LOOKING FOR WHERE
THAT'S GOING TO GO BECAUSE IT'S
A MARKET OPPORTUNITY FOR YOU OR
LOOKING AT THE SOLICITATION ERIC
OR STEPHANIE PUTS OUT AND
BUILDING THE LEGOS AFTER THAT?
>> GREAT QUESTION, SHAWN.
SAVROS IS A LITTLE BIT DIFFERENT
THAN A LOT OF OTHER COMPANIES.
WE'RE MORE OF A PORTFOLIO
COMPANY SO WE HAVE THE
OPPORTUNITY TO DO THIS LEGO
BUILDING BLOCKS TYPE THING AND
TAKE TECHNOLOGY FROM HERE AND
THERE AND PUT IT TOGETHER.
I THINK ESSENTIALLY HOW WE THINK
ABOUT THIS FALLS INTO TWO
DIFFERENT POCKETS.
ONE IS OPPORTUNISTIC AND LIKE A
START UP GO WHERE THE MONEY IS
AND THE RADX 3 PROGRAM IS AN
OPPORTUNITY WE WENT AFTER.
WHEN THE CALL CAME OUT A YEAR OR
SO AGO AND WHEN WE LOOKED AT IT,
WE ALREADY HAD A BASE PLATFORM.
WE HAD OUR GEN 1 BASED ON
COMBINASE POLYMERASE BUT IT'S A
CLUNKY DEVICE SINGLE USE AND
WHEN WE LOOKED AT THIS AND AT
THAT TIME WE ACQUIRED
FLEXITRONICS CHANGED THE WAY WE
THOUGHT ABOUT IT SAYING THIS IS
OUR OPPORTUNITY TO DEVELOP THE
NEXT GENERATION OF THIS
MOLECULAR PLATFORM.
WE HAVE BIO CHEMISTRY.
WE CAN THINK ABOUT AN ALTERNATE
REAGENT STRATEGY THAT
POTENTIALLY MOVES AWAY FROM
REAGENTS AND WE CAN GO TOWARDS
INSTEAD OF IN SECTION MODELLED
PROJECTS WE CAN GO TO THERMAL
MODELLING AND NOW HAVE THIS
CAPABILITY AND HOW DO YOU LAYER
THOSE IN?
THE OTHER THING I'D SAY IS THAT
WITHOUT THAT FUNDING WE WOULD
NOT HAVE EMBARKED ON THE NEXT
GENERATION TEST.
IT'S A MASSIVE BOOST FOR A
COMPANY LIKE OURS.
THE SECOND CATEGORY THAT FITS
INTO IS WHAT I'LL CALL MARKET
NEED.
AND THERE'S POINT-OF-CARE
DIAGNOSTICS AND MANY SEEN IT ALL
AND KNOW WHERE THE PROBLEMS ARE.
WE'RE ALSO DEVELOPING A DIGITAL
PREGNANCY TEST.
WHY WOULD YOU DO THAT?
THERE'S LOTS OF PREGNANCY TESTS
OUT THERE BUT THAT WAS AN
EXERCISE IN GETTING PRODUCT OUT
TO MARKET AND START IT GET
REVENUE AS SOON AS POSSIBLE.
IT HAS A MUCH LOWER REGULATORY
HURDLE.
THERE IS APPETITE FOR CHANGE
ESPECIALLY FOR A LOWER COST TEST
LIKE THE ONE THAT WE WOULD
DESIGNS THOSE ARE CONSIDERATIONS
AND THERE'S STAGES OF COMPANIES.
WE'RE AT A STAGE WHERE IT'S
DEFINITELY OPPORTUNISTIC AS
SOLICITATIONS COME OUT WE SAY
DOES IT MAKE SENSE TO APPLY TO
IT AND THEN DO AND THEN SIT BACK
AND WAIT AND SEE WHAT HAPPENS.
>> IN THE INTEREST OF TIME I'M
GOING TO FAST FORWARD OUR
CONVERSATION A LITTLE BIT IF YOU
DON'T MIND AND JUMP TO THE
DEVELOPMENT FACET.
WE HAVE AN IDEA WE'RE BUILDING.
I'LL TURN TO YOU, ERIC, WHAT DO
YOU SEE AS THE KEY RELATIONSHIPS
THE DEVELOPERS BE PUTTING IN
PLACE IF THE COMPANY TRULY WANTS
TO BE SUCCESSFUL THEY'RE GOING
TO MAKE IT TO THE END OF THIS
RACE.
ARE WE TALKING QUALITY SYSTEMS
OR ARE WE TALKING ABOUT
PREPARING FOR ANALYTICALS OR
CLINICALS AND WHAT ARE THINGS
THEY SHOULD START DOING.
>> IT MAY NOT BE SOMETHING YOU
WANT TO HEAR BUT FIRST THING YOU
HAVE TO DO IS HIRE THE RIGHT
PEOPLE.
I'VE SEEN SO MANY PEOPLE COMING
IN WITH THE FOUNDER AND THE REST
OF THE FOLKS THEY HAVE ARE NOT
THE RIGHT FOLKS.
THEY MAY BE RESEARCH OR QUALITY
AND SO FORTH.
THAT'S NUMBER ONE.
ALL THE PEOPLE IN IT ARE
HANDPICKED.
WE DON'T HAVE AN HR DEPARTMENT.
YOU PERFORM OR YOU'RE OUT.
IF YOU DON'T PERFORM, WE DON'T
WANT IT TALK TO YOU.
THAT'S THE IMPORTANT PART.
YOU HAVE TO HAVE THE RIGHT
PEOPLE AND UNDERSTAND YOUR
PRODUCT.
I HAVE A LOT OF COMPANIES COME
AND TALK TO US ABOUT WHAT IS
YOUR TARGET PRODUCT PROFILE AND
THEY HAVE NO CLUE.
SO HIRE THE RIGHT PEOPLE AND
KNOW YOUR TOY, WHATEVER IT IS
AND IT'S GOOD FOR AND GO FOR IT.
>> YOU SAID OPPORTUNISTIC AND
LOOKING AT THE MARKET AND SHE'S
TELLING YOU TO KNOW WHAT YOUR
MARKET IS.
WHEN ARE YOU AS A COMPANY
LOOKING AT THAT FINAL PRODUCT?
LIKE THE PRODUCT I'M GOING TO
PUT IN THE HAND OF THE USER.
WHEN ARE YOU STARTING TO DESIGN
FOR THAT AND BUILDING YOUR LEGO
SET WE JUST DESCRIBED.
WHEN IS THE USER AT THE END
COMING INTO YOUR DESIGN PHASE?
>> I THINK AS TECHNOLOGY
DEVELOPERS, ONE OF THE PITFALLS
IS THAT WE DON'T THINK ABOUT
USER REQUIREMENTS EARLY ENOUGH.
AND I THINK WHAT I FOUND THAT
BOTH AT SAVROS AS WELL AS VISBY
IS THAT YOU NEED TO START WITH
USER REQUIREMENTS.
YOUR USER CUSTOMER REQUIREMENTS
GIVE YOUR R&D TEAM GUARD BANDS
OF WHAT TO DEVELOP.
YOU'RE NOT BEING OVERLY
PRESCRIPTIVE AND TELLING THEM
WHAT TO DO BUT TELLING THEM FROM
THE USER PERSPECTIVE THE PRICE
OF THE TEST NEEDS TO BE X AND
THINK OF IT IN TERMS OF A
MINIMUM VIABLE PRODUCT AND A
TARGET.
AND YOU THINK ABOUT YOUR TARGET
AS LIKE STRETCH GOALS.
EVEN IF YOU DON'T MEET THAT YOU
WILL STILL HAVE A VIABLE PRODUCT
ON THE MARKET.
THE OTHER THING THAT'S IMPORTANT
IS LOW-COST MANUFACTURING.
IN THE EARLY DAYS WE'RE JUST
TRYING TO GET THE TECHNOLOGY TO
WORK AND WE DON'T REALLY THINK
ABOUT OKAY, IF I MAKE THIS SMALL
CHANGE TO THIS DEVICE, HOW DOES
THAT IMPACT MANUFACTURING DOWN
THE LINE?
YOU CONSTANTLY NEED TO BE
THINKING ABOUT DESIGN FOR
MANUFACTURING.
AND I'M A BIOLOGIST.
I'M NOT AN ENGINEER BUT I WOULD
CAUTION PEOPLE.
START WITH USER REQUIREMENTS,
USE THAT AS GUARD BANDS AND THEN
ALWAYS BE THINKING ABOUT HOW YOU
ARE GOING TO BE TRANSITIONS YOUR
PROTOTYPE DEVICE INTO A
MANUFACTURING ENVIRONMENT.
I THINK THAT'S REALLY KEY.
AND I THINK THE PEOPLE YOU NEED
TO HAVE THE RIGHT PEOPLE WHETHER
IT'S QUALITY, MANUFACTURING OR
CLINICAL, REGULATORY THAT'S ALSO
AN IMPORTANT PIECE.
>> SO YOU WANT A USER FRIENDLY,
EASILY MANUFACTURED DEVICE,
RIGHT?
WHEN YOU'RE DESIGNING, WHO
GUIDES HOW YOU'RE DEFINING THAT
MARKET OPPORTUNITY?
TO THE PAYER OR USER.
>> SHORT ANSWER BOTH IMPORTANT.
REIMBURSEMENT IS AN IMPORTANT
PART AND I LEARNED THE TERM,
PERI MARKETING STUDIES.
I LOVE THAT BECAUSE IT'S
IMPLEMENTATION AND HEALTH
ECONOMIC STUDIES.
YOU'RE DOING OFF SET WITH YOUR
CLINICAL STUDIES.
ONCE YOU HAVE A STABLE DEVICE.
YOU KNOW YOU'RE GETTING GOOD
RESULTS FROM YOUR CLINICAL
STUDY.
THAT'S WHEN YOU START THE REAL
WORLD IMPLEMENTATION STUDIES.
WE KNOW THE FDA PROCESS TAKES A
LONG TIME, SIX TO 12 MONTHS
DEPENDING ON WHICH PATH YOU'RE
GOING DOWN.
BY THE TIME YOU HAVE FDA
APPROVAL YOU HAVE A BODY OF DATA
TO TAKE TO PAYERS AND CLINICS OR
WHOEVER YOU'RE TRYING TO
IMPLEMENT THAT PARTICULAR
TECHNOLOGY INTO.
IT'S IMPORTANT TO START EARLY IN
THINKING ABOUT IT.
ESPECIALLY IN START-UPS WE'RE
DOING A LOT BUT THAT'S A KEY
PIECE.
IT ISN'T JUST ABOUT GETTING THE
TECHNOLOGY TO WORK BUT GETTING
IT TO WORK AND INTO THE HANDS OF
PEOPLE AND ADOPT IT BECAUSE
WITHOUT ADOPTION YOU DON'T HAVE
A TECHNOLOGY.
>> STEPHANIE.
WE HAVE DEVELOPERS AND SAY
YOU'VE HIRED ONE ON A PROJECT,
WHAT MAKES THEM A GOOD PARTNER
TO YOU AS A PROGRAM MANAGER TO
THE DEPARTMENT OF DEFENSE AS
THEY LOOK AT ACQUISITION?
>> PEOPLE MAKE A BIG DIFFERENCE.
WE KNOW THE FEDERAL GOVERNMENT
WRIT LARGE NOT ONLY THE DOD IS
INCREDIBLY BUREAUCRATIC.
IT'S EASY TO LABOR THE
PROCESSES.
HOW TO INVOICE AND WRITE A
STATEMENT OF WORK AND FIND THE
PEOPLE WHO OPENLY, HONESTLY,
COMMUNICATE WELL.
OUR MAJOR MILESTONES ARE HOW WE
GAUGE SUCCESS WANT TO SEE THE
EFFORTS IS BEING MET.
SNT GUARANTEE YOUR TIME SLIPS
BECAUSE THINGS WON'T GO TO PLAN
AND SOMETIMES THE SUPPLY CHAIN
SOMETIMES FALLS A PART AND YOU
HAVE DELAYS GETTING MATERIAL AND
THINGS YOU NEED SO YOU GET A
NO-COST EXTENSION TO PUSH THE
WORK OUT AND THOSE WHO SUCCEED
ARE THE ONES WHO LEARN WELL HOW
TO COMMUNICATE AND VERY EARLY ON
TAKE A HOLISTIC VIEW OF THE
PROJECT AND IDENTIFY EARLY I
THINK NOT JUST THE SUCCESSES AND
DEVELOPING MITIGATION STRATEGIES
AGAINST THE RISK.
HAVING THE FORETHOUGHT IN TAKING
THE EXTRA TIME TO THINK THROUGH
ALL PIECES OF THE PUBLIC HEALTH
AND TRY TO THINK IN ADVANCE OF
HOW YOU'RE GOING TO SOLVE ISSUES
THAT ARISE BE SMALL LARGE ONES
THOSE ARE THE FOLKS THAT I SEE
BEING REALLY SUCCESSFUL COMING
TO US EARLY, WE'RE HAVING THIS
PROBLEM -- NOT A BIG DEAL BUT DO
YOU GUYS HAVE THOUGHTS ON AND
BEING ABLE TO TWEAK THINGS
EARLIER THAN FOR EXAMPLE THE
FOLKS WHO SIT ON IT BECAUSE THEY
DON'T WANT TO UPSET US OR THINK
THEY MIGHT LOSE THEIR FUNDING
OVER IT AND THEN WE DON'T FIND
OUT UNTIL THEY'RE MISSING THE
MILESTONE AND CAN'T ACCOMPLISH
IT AND IT'S LIKE WHAT DO YOU
WANT US TO DO NOW AND NOW IT'S
TOO LATE.
LOOKING NOT JUST THE SUCCESS BUT
MITIGATION PATHWAYS TO FOLLOW IN
THE PROCESS AND OPEN AND HONEST
COMMUNICATION.
THE MORE COMMUNICATION THE
BETTER WHETHER POSITIVE OR
NEGATIVE WORKING THROUGH THINGS
TOGETHER WE ALWAYS HAVE TO
MESSAGE UP TO OUR LEADERSHIP AND
FUNDING TEAM TO CONTINUE TO
DEVELOP TECH ALONG THEMES OR
AREAS AND THE MORE WE CAN
MESSAGE UP HOW TO MITIGATE RISK
HELPS IN THE LONG RUN.
>> YOU PICKED THE RIGHT HORSE.
THE COMPANY IS DOING
WONDERFULLY.
THE DIAGNOSTICS IS COMING ALONG.
WHAT'S THE TRANSITION FROM DITRA
AND WHEN DO YOU LINK THEM FROM
THE FDA OR REGULATORY?
>> FDA IS ALWAYS LISTED FOR ANY
PROTOTYPE DEVELOPMENT EFFORT.
WE EXPECT AND HELP FACILITATE A
PRESUBMISSION MEETING.
WE HAVE A TEAM IN HOUSE AND
SOMETIMES THEY HAVE HELPED CRAFT
AN APPROACH IF THAT'S NEEDED OR
ASKED FOR.
WE TAP OUT AT EARLY 4 AND EARLY
TECH AND SET YOU UP FOR SUCCESS
DOWN THE ROAD WITH YOUR ADVANCED
DEVELOPMENT.
LOOKING TO THAT PIECE OUR
PRIMARY ADVANCED DEVELOPER IN
THE BIO CHEM PROGRAM IS THE
EXECUTIVE OFFICE.
WE DO A LOT OF COMMUNICATION
INTERNALLY ON A MONTHLY BASIS
AND FORMALLY QUARTERLY AND WHAT
TECHNOLOGY WE'RE DEVELOPING AND
WHAT THE TIME LINES ARE FOR
COMPLETION AND ANY MAJOR
MILESTONES AND HOW THEY FIT INTO
EXISTING PROGRAMS OF RECORD.
HOW WE MAY BE ABLE TO WORK
MOVING FORWARD.
WE INVITE ADVANCED DEVELOPERS TO
THE VAST MAJORITY OF OUR MONTHLY
CALLS WE'LL SHARE REPORTS AND
THINGS LIKE THAT THOUGH WE DON'T
HAVE A WHOLE LOT OF INVOLVEMENT
WITH THE FDA OTHER THAN THE
QUESTED OR NEEDED WE HAVE
COLLABORATION ON THE ADVANCED
COORDINATION PIECE AND PUSHING
WITH OUR ADVANCED DEVELOPERS TO
GET THE PERFORMER AND PROJECT
AND GET THEIR FEEDBACK AND THEY
HAVE A MORE PRESCRIPTIVE SET OF
WHAT THEY NEED TO SEE TO FEEL
CONFIDENT TO PICK UP THE
TECHNOLOGY MOVING FORWARD SO
THEY OFTEN INTRODUCE MORE OF THE
TRANSITION ACQUISITION LANGUAGE
OF OBJECTIVE AND THRESHOLD AND
THEIR PARAMETERS FOR SUCCESS WE
TRY HARD AND RARELY WAIT UNTIL
THE PROJECT IS NEARING
COMPLETION.
THEY'RE INVOLVED FROM THE
BEGINNING OR AT LEAST MIDDLE.
>> I'LL HIT FAST FORWARD ONE
LAST TIME AS THE LAST SECTION
AND TURN IT TO THE AUDIENCE FOR
QUESTIONS.
TERESA, LET'S TALK ABOUT A
PRODUCT ON THE MARKET.
HOW ARE WE GOING SUSTAIN IT?
WHAT ARE THE EARLY INDICATORS
THAT TELLS YOU THE PRODUCT IS
DOING WELL OR NEEDS SUPPORT?
WHAT IS THAT ACUTE BEGINNING OF
THE PRODUCT.
>> I THINK LEARNING FROM LAST
PROJECT AND HAD VAGINAL SWABS
AND HAD A USERABILITY STUDY BUT
LEARNED IT'S ALL ABOUT THE
BOTTOM LINE.
IF IT DOESN'T MAKE ECONOMIC
SENSE FOR A CLINIC OR PLANNED
PARENTHOOD TO IMPLEMENT THE TEST
THEY WON'T DO IT HOWEVER, COOL
IT IS OR HOW MUCH IT WILL CHANGE
PATIENT WORK FLOW OR WORK FLOW
IN THE CLINIC AND YOU DON'T HAVE
TO CALL PATIENTS BACK OR TREAT
THE PATIENT RIGHT THERE, ALL THE
UPSIDE, WHAT WE LEARNED IS THAT
IT DOES MATTER THE PRICE OF THE
TEST HOW MUCH IT COSTS.
THE BOTTOM LINE REALLY MATTERS.
WHAT'S IMPORTANT TO DO IS TO
ENGAGE WITH THE BUSINESS SIDE OF
THE CLINIC OR WHICHEVER SETTING
YOU'RE TRYING TO GET INTO.
GET THEM ENGAGED EARLY IF I HAD
TO DO IT DIFFERENTLY THAT'S
WHERE I'D START IN ADDITION TO
WORKING WITH CLINICIANS.
I'LL GIVE AN EXAMPLE OF
SOMETHING THAT WORKED WELL AND
YUKA KNOWS THIS WE DID AN
ECONOMIC STUDY IN THE HOPKINS
POINT-OF-CARE LAB IN THEIR E.D.
AND WORKED WITH YUKA AND OTHER
PEOPLE IN HOW WE'D IMPLEMENT THE
TEST AND EVERY TWO WEEKS WE HAD
A CALL AND THERE WERE LITERALLY
25 PEOPLE ON THE CALL.
THERE WAS A NURSING COORDINATOR,
THE E.D. -- THERE WERE SO MANY
PEOPLE ON IT AND THAT'S WHEN I
REALIZED YOU NEED ALL THOSE
PEOPLE TO COME TOGETHER AND TO
MOVE IN THE SAME DIRECTION
THAT'S SOMETHING THAT REALLY
WORKED WELL.
THE OTHER THING IS I THINK
SOMETIMES WE HAVE AN IDEA FOR A
TEST.
WHEN YOU GO TO IMPLEMENT IT
PEOPLE ARE TELLING YOU IT'S NOT
THE RIGHT PLACE.
THEY MAY NOT BE THAT OPEN AND
DIRECT.
IT'S IMPORTANT TO LISTEN TO WHAT
PEOPLE SAY.
I THINK A LOT OF TIMES WE SAY
OH, BUT BUT IT'S IMPORTANT TO
LISTEN.
I KNOW I DIDN'T ANSWER ABOUT
ECONOMIC INDICATORS.
>> IT'S GOOD THOUGHTS AND
STEPHANIE, YOU OFTEN FUND FOR
MORE NICHE DISEASES AND MAY NOT
BE COMMON BUT MAYBE FOR THE DOD
AND WHAT DO THEY DO TO SUSTAIN
PRODUCT CAN'T SUPPORT ITSELF
JUST ON A SPECIFIC DIAGNOSTIC.
WHAT MEASURES ARE YOU TAKING?
>> AND THE KURT ANSWER IS WE
DON'T.
WE CAN'T BE A SUSTAINMENT ARM.
WE DON'T HAVE THE FUNDING AND
TRY TO BE AS UP FRONT AS
POSSIBLE WITH A LOCKHEED CAN
HAVE THEIR NICHE MARKETS AND
ALSO MORE BROADER APPLICATION AS
WELL BUT WHEN YOU GET INTO THE
SMALL START UP COMPANIES OUT OF
SILICON VALLEY, FOR EXAMPLE,
IT'S TOUGH.
WE FUND A PORTION WHAT THE
COMPANIES HAVE A BROADER MARKET
FOR.
THAT HELPS.
FOR EXAMPLE, WE'RE DOING A
WEARABLE EFFORT AND THEY'RE
DEVELOPING THEIR CONTINUOUS
MONITORING DEVICE FOR DIABETES
AND LOOKING FOR GLUCOSE AND
STARTED LOOKING AT LACTATE
SEBSERS.
WE MAY NOT BE INTERESTED IN
GLUCOSE BUT ARE INTERESTED IN
LACTATE.
WHEN WE PUT THE RFI OUT SAYING
WE'RE LOOKING FOR A CONTINUOUS
WEARABLE MONITORING DEVICE FOR
OXYGEN, LACTATE AND GLUCOSE, FOR
EXAMPLE, OR NOT GLUCOSE BUT
ACETYL CHOLINE THAT COMPANY
ALREADY HAS START THE WORK FOR
LACTATE AND CAN USE THE MODEL
AND PABLG WAYS AND A LOT OF THE
EARLY SCIENCE AND BENCH WORK
THEY DID FOR THAT DEVICE AND
JUST WORK TOWARDS OUR NICHE AND
PROPOSE TOWARDS OUR NICHE.
AND THE MINIATURIZATION AND
STUDIES WE'LL FUND AND EARLY T
AND E EVALUATION AND LABORATORY
ANALYSIS HELPS WITH THE OTHER
PIECES AS WELL.
LONG ANSWER SHORT IS WE'RE NOT A
SUSTAINABILITY PARTNER AND CAN'T
BE BUT WE DO TRY TO COMMUNICATE
THAT AS BEST AS POSSIBLE AND
ENCOURAGE APPLYING TO OTHER
GRANTS, OTHER OPPORTUNITIES
SOMETIMES INCLUDED IN THE
ADVANCED AND ARE WE YOUR ONLY
FUNDER AND MEANS OF STAYING
VIABLE OR DO YOU HAVE OTHER
MECHANISMS AND APPLICABILITY TO
A BROADER MARKET THAN NOT JUST
THE DOD BUT CV APPLICABILITY
WITHIN THE DOD.
>> AND FINAL QUESTION, ERIC,
YOU'VE WORN HATS IN DIFFERENT
INDUSTRIES AND WHAT ARE SOME
THINGS TO THINK ABOUT, WHAT
TRIGGERS REGULATORY CHANGES THEY
NEED TO WORRY ABOUT BEFORE THEY
MAYBE PIVOT THEIR PLATFORM AND
HAVE A PANEL OF THINGS OR TALK
ABOUT SEASONALITY AND VARIANT
CHANGES AND WHAT THAT MIGHT MEAN
FOR THEM?
>> I FULLY UNDERSTAND A LOT OF
SCIENTISTS AND COMPANIES AND
FOUNDERS AND SO FORTH ARE VERY
PASSIONATE ABOUT THEIR WORK AND
TECHNOLOGY AND SO FORTH.
BUT MY NUMBER ONE ADVICE TO YOU
IS DO NOT DEVELOP PERSONAL
ATTACHMENT TO YOUR PRODUCTS
BECAUSE I UNDERSTAND IT'S YOUR
BABY BUT SOME BABIES ARE UGLY.
AND A LOT OF TEENAGERS ARE
TROUBLESOME.
SO VEEP IF YOU DEVELOP YOUR
FIRST PRODUCT AND GO INTO A
SECOND PRODUCT, YOU REALLY HAVE
TO OPEN YOUR EYES AND HAVE A
FAIR ASSESSMENT.
I CANNOT TELL YOU HOW MANY TIMES
I TRY TO CONVINCE COMPANIES
THEIR ANTIBODIES DO NOT WORK
WHEN THEY GO FROM DELTA TO
OMICRON BUT THEY DON'T BELIEVE
IT AND KEEP PLOWING INTO IT OR
REGIONS THEY CHOSE EARLY ON IS
GOING TO COME OUT WITH PROBLEMS
EVERY TIME IT'S A NEW VARIANT
COMES UP.
YOU SHOULD CHANGE YOUR APPROACH.
THEY WON'T LISTEN.
IT'S VERY IMPORTANT TO REALLY
LOOK AT THE DATA AND BE FAIR.
THE OTHER THING IS WHEN YOU
DEVELOP THE NEXT PRODUCT YOU
HAVE TO MAKE SURE IT'S
COMPATIBLE.
YOU WOULD NOT BELIEVE HOW MANY
COMPANIES WENT FROM COVID TO
COVID COMBO AND CHANGE THEIR
BUFFER AND ADD MORE PROTEIN IN
THE BUFFER TO STABILIZE THE FLU
ANTIBODIES PART AND NEVER WENT
BACK TO TEST WHAT IT DID TO THE
COVID ASSAY AND THEY ALL SAY,
OH, WOW, IT DIDN'T QUITE WORK OR
THE COVID ASSAY, WELL, DUH.
AND THE FINAL THING I'D LOVE TO
BRING UP WHICH IS SOFTWARE.
WHEN SOFTWARE ENGINEER COMES AND
SAYS WE JUST NEED A LITTLE
CHANGE.
IT SHOULD WORK.
NEVER BELIEVE THAT.
IT ALWAYS FAILS AND AT THE END
IT'S THE SOFTWARE.
HOPEFULLY YOU GUYS DON'T SUFFER
THE SAME PAIN AND SUFFERING I'VE
DONE BEFORE.
>> THANK YOU VERY MUCH.
IF WE CAN THANK THEM FOR THEIR
ANSWERS TO MY SETS OF QUESTIONS.
I OPEN THE MIC TO THE AUDIENCE
FOR ANYONE WHO WANTS TO GET INTO
THIS BRAIN TRUST.
WHILE WE WAIT I'LL START WITH
YOU ERIC, WHAT ARE PARTNERSHIPS
BEHIND THE SCENES WE'RE BUILDING
MAYBE ACROSS HHS TO GET SOME OF
THESE THINGS READY FOR A CALL
OUT TO THE DEVELOPER AND WHO ARE
WE TALKING TO TO SET UP BEHIND
THE SCENES SO THE OVER ALL
PROGRAM CAN BE SUCCESSFUL IF WE
GET THE RIGHT TECHNOLOGY
DEVELOPER IN THE FRONT DOOR?
>> WE'RE DOING A LOT BETWEEN NIH
AND NIA.
WHEN YOU SEE FOR EXAMPLE AN ITAB
SOLICITATION.
IT HAS A LOT OF THOUGHT BEHIND
IT AND A LOT OF THE BACKGROUND,
A LOT OF THE PROTOCOLS AND HOW
TO DO THINGS HAS BEEN SORTED
OUT.
SO WHEN YOU COME TO THE PROGRAM
YOU NEED TO LISTEN TO US BECAUSE
IT'S NOT SOMETHING WE CAN CHANGE
FOR YOU BECAUSE WE WORKED OUT
ALL THESE THINGS.
AND PEOPLE DON'T REALIZE.
PEOPLE WILL SAY WE TALKED TO THE
FDA AND THEY SAID IT'S THAT WAY
AND WE SAID IF YOU WANT TO DO
THAT HAVE FUN DIRECTLY WEDGE
WITH THE FDA WE DON'T DO THAT.
WE HAVE THE BACKGROUND AGENCY
SORTED OUT AND AGREE WITH THE
OTHER AGENCIES.
>> ONE MORE.
>> I'M PART OF NIBIB AND BOSTON
CHILDREN'S HOSPITAL AND IN MY
PERSPECTIVE THERE'S A BIT OF A
VOID IN EARLY AVAILABILITY OF
EARLY GUIDANCE ON DEVICE DESIGN
AND SO FOR THIS AUDIENCE AND
DEVELOP
DEVELOPERS I'M NOT SURE THERE'S
CLEAR GUIDANCE NECESSARY FOR
CLINICAL ADOPTION AND MAKING
SURE IT'S COMPATIBLE WITH LAB
WORK FLOW AND WHAT I MEAN BY
THAT ARE CONTROLS AND PROCESS
CONTROLS, HOW DO YOU DESIGN
PROCESS CONTROLS TO MINIMIZE
EXTERNAL QC AND KEEP COSTS DOWN
AND HOW TO YOU ANTICIPATE WHAT
THE FDA WILL APPROVE FOR DESIGN
OF A VERY NOVEL DEVICE AND HAVE
YOU NOTHING TO LOOK TO AS AN
EXAMPLE FOR CONTROL DESIGN
DECISIONS?
YOU'RE TOO EARLY TO SUBMIT TO
THE FDA AND LABORATORIANS.
DO YOU HAVE FEEDBACK HOW
DEVELOPERS IN THIS AUDIENCE
SHOULD GET FEEDBACK FROM THE
EARLY BUT CRITICAL DESIGN
DECISION IMPACT THE ENTIRE
PATHWAY DESIGN AND HOW EASY WILL
IT BE ABLE TO DETECT A NEW ANNO
-- THE ANOLYTE.
ANY FEEDBACK?
>> THE BENEFIT AND CURSE AT THE
DOD IS WE HAVE A CLOSE FEEDBACK
LOOP.
WE AT THE EARLY TECH DEVELOPMENT
OFFICE WE DO HAVE VERY EARLY
TECH.
USUALLY WE'RE PICKING IT UP WELL
BEFORE THEY'RE READY FOR THE
PRECEPTS SO WE MAY PUT THAT AS A
MILESTONE.
WE'RE DEVELOPING TO GET THEM
READY FOR THE PRESEP AS WELL.
WE DO QUITE A BIT OF USER
FEEDBACK STUDIES.
WE HAVE SEVERAL EVENTS AND TECH
DEMOS AND OPERATIONAL EXERCISES
THAT SPREAD THE GAMUT FROM HEY,
HERE'S A CONCEPT TO HERE'S AN
EARLY PROTOTYPE TO HERE'S A
LATER EARLY PROTOTYPE AND WE
ACTUALLY HAVE MEMBERS FROM ALL
THE SERVICES EXCEPT MAKE SPACE
FORCE AND GIVE FEEDBACK DOWN TO
AN INNER WEARABLE AND THEY SAID
CAN YOU CHANGE THE COLOR BECAUSE
THIS IS GOING TO BE THROWN IN
OUR BAG AND I'M NOT GOING TO
FIND IT.
IT'S TOO SMALL.
CAN YOU MAKE IT ORANGE TO EASILY
SEE IT IN MY KIT AND PICK IT UP.
WE GET FEEDBACK DIRECTLY FROM
THE SERVICES.
WE ALSO GET FEEDBACK FROM THE
REQUIREMENTS OFFICE THAT FED US
THE REQUIREMENT TO BEGIN WITH
AND OUR ADVANCED DEVELOPER HAS
PRESCRIPT REQUIREMENTS BY THE
TIME IT COMES TO THEM ON WHAT
THEY'D LIKE TO SEE FOR FORM,
FIT, FUNCTION, SIZE,
SPECIFICITY, SENSITIVITY.
WE TYPICALLY TRY TO HAVE MONTHLY
MEETINGS WITH ALL OF OUR
PERFORMERS AND DO QUARTERLY OR
TWICE A YEAR REVIEWS AND GIVE
FEEDBACK TO GET ADDITIONAL
FEEDBACK ON JUST THAT.
>> I THINK I'M THINKING LESS
ABOUT USABLE THAN ABOUT ACTUAL
INTERNAL CONTROLS, FOR EXAMPLE.
THE DESIGN AND THINGS GOING IN
SEPARATE LANES.
WHAT IF YOU WANT TO HAVE A
QUANTITATIVE TEST TO USE IN A
WAVED ENVIRONMENT?
WHAT YOUR CONTROLS NEED TO DO IN
ORDER TO SPARE YOU EXPENSIVE QC
DOWN THE LINE.
THE LESS USABILITY AND MORE
ACTUAL ASSAY DESIGN AND
THEREFORE DEVICE DESIGN.
>> IT'S A GREAT POINT YOU BRING
UP.
A LOT OF TIMES WE'RE MAKING
DESIGN DECISIONS IN A VACUUM.
ONE NICE THING ABOUT RADX HAS
BEEN THE DIRECT LINE TO THE FDA.
I THINK THAT'S SOMETHING WE NEED
TO MAINTAIN FOR OTHERS WHO DON'T
HAVE A GOVERNMENT SPONSOR AND IF
YOU TALK TO BARDA OR WHATEVER
YOU HAVE THE OPPORTUNITY FOR THE
DIRECT LINE TO THE FDA TO ASK
THESE QUESTIONS.
WHAT ENDS UP HAPPENING IS WE
WAIT UNTIL WE HAVE SOMETHING
THAT'S MORE MATURE AND THEN WE
GO TO THE FDA WITH AND SAY WHAT
DO YOU THINK?
AND YOU HAVE TO GO TO THE
DRAWING BOARD.
THERE NEEDS TO BE OPPORTUNITIES
AND I THINK IT'S ON US REALLY.
AND BY US I MEAN NIH AND MAKE
SURE THE CONDUIT IS IS AVAILABLE
FOR TECHNOLOGY AND DON'T WANT TO
GO DOWN THE WRONG ROAD AND HEARD
COME TALK TO US EARLY AND OFTEN
BUT TECHNOLOGY DEVELOPERS ARE
SCARED TO DO THAT.
THEY DON'T WANT TO BE BOUND TO
SOMETHING THAT THE FDA SAYS I
DON'T THINK THAT'S BEEN TAKEN
ADVANTAGE OF YET BUT THERE NEEDS
TO BE A FORUM TO GET FEEDBACK
FROM THE FDA.
>> I THINK THAT'S AN AREA THAT'S
MISSING RIGHT NOW BECAUSE OF THE
WAY THE FDA AND NIH AND
YESTERDAY IT WAS SAID NICELY HOW
THE AGENCY IS SET UP.
THERE'S NO WAY TO DO AND RADX
AND ITAB IS SUCCESSFUL AND IT'S
EXACTLY THAT.
WE CAN TALK TO THEM.
WE DON'T DO PRECEPTS.
I'M THE PRECEPT.
PICK UP THE PHONE AND CALL THEM.
RIGHT NOW THAT'S MISSING.
>> THANK YOU.
>> THIS HAS BEEN WONDERFUL.
I COULD SIT HERE AND TALK TO YOU
GUYS A LOT LONGER BUT OUR TIME
IS UP.
CAN WE PLEASE THANK THE
PANELISTS FOR THEIR TIME TODAY.
AND TIFFANI, WE YIELD THE STAGE.
>> THANK YOU.
NOW WE'LL TAKE A BREAK TO 10:35.
WE WON'T OVER A LITTLE BIT.
THE BREAK IS IS ACTUALLY IN THE
CAFETERIA SO YOU HAVE TO GO
UPSTAIRS.
10:35 WE'LL RECONVENE. THANK YOU.
WE'RE GOING TO GET STARTED
WITH OUR SECOND SESSION FOR
TODAY.
FOR TODAY WE WILL HAVE CALLED
POINT-OF-CARE TECHNOLOGIES AND
INNOVATION AND TECHNOLOGY
TRANSLATION, VALIDATION AND
BUSINESS MODEL FOR
COMMERCIALIZATION.
THIS WILL BE CHAIRED BY TODD
MERCHAK.
>> GOOD MORNING AND WELCOME BACK
FROM THE BREAK.
I'M EXCITED TO CHAIR THIS PANEL
SESSION TODAY.
WE HAVE TWO EXCITING SPEAKERS
AND AS FAR AS TECHNOLOGY
TRANSLATION, VALIDATION AND
COMMERCIALIZATION IN THE AREA OF
POINT-OF-CARE TESTING WE HOPE TO
SHARE WITH YOU TODAY SOME
THOUGHTS WE HAVE COMPLIED
THROUGH THE PAST FEW YEAR OF THE
RADX INITIATIVE.
AS YOU HEARD ABOUT YESTERDAY AND
A BIT TODAY RADX WAS CHARGED
WITH DEPLOYING BILLIONS OF COVID
TESTS IN RESPONSE TO THE
PANDEMIC.
TIME WAS OF THE ESSENCE
REQUIRING US WAYS TO FIND
EFFICIENCIES IN OUR PROGRAMMATIC
SYSTEMS AND WE HAD A BILLING TO
LIVE UP TOP HAVING BEEN
ALLOCATED AMPLE RESOURCES WE
WERE ABLE TO GREATRY ACCELERATE
PROJECTS WITH A MORE PARALLEL
APPROACH TO TRANSLATION AND
COMMERCIALIZATION.
OPPOSED TO THE MORE TRADITIONAL
AND SEQUENTIAL MILESTONE
DEVELOPMENT PATHWAYS TO MANAGE
AND MITIGATE RISK WE DEPLOYED
STRATEGY ACROSS ALL CLINICAL
DOMAINS AT THE SAME TIME AND
HELPED FILL IN KNOWLEDGE GAPS
WIN OUR PORTFOLIO COMPANIES TO
MOVE PROJECTS FORWARD.
OUR ASSUMPTION AT THAT TIME WAS
MOVING THIS QUICKLY AND IN
PARALLEL MEANT ASSUMING MORE
RISK AND INHERENTLY MEANT A
LOWER RATE OF SUCCESS IN
BRINGING PROJECTS ALL THE WAY
THROUGH TO COMMERCIALIZATION.
WE WERE ALL A BIT SURPRISED WHEN
THAT TURNED OUT NOT TO BE OUR
EXPERIENCE.
THROUGH THE ACCELERATED PACE
REQUIRED ROBUST RISK ASSESSMENT
METHODS TO ENSURE WE HAVE
SELECTED PROJECTS THAT MAY HAVE
THE GREATEST CHANCE OF
COMMERCIAL SUCCESS AND MIGHT
BEST BE ABLE TO LEVERAGE THE
SYSTEMS.
ONCE PROJECTS HAD BEEN SELECTED
IT WAS EQUALLY IMPORTANT TO HAVE
STRONG MILESTONES TO TRACK
PROGRESS.
VALIDATION OF PROGRESS THROUGH
STANDARDIZED AND INDEPENDENT
MEANS WAS CRITICAL TO THE
TRANSLATION AND
COMMERCIALIZATION PROCESS.
KNOWING WHEN TO REE -INVEST OR
PIVOT AND LOOK AT HOW IT MAY BE
MAINTAINED AND I'D LIKE TO
INTRODUCE OUR FIRST SPEAKER MIKE
DEMPSEY IS AN ENTREPRENEUR AND
RESIDENT AT THE CENTER FOR
MEDICINE AND INNOVATIVE
TECHNOLOGY PROVIDING LEADERSHIP
IN COMMERCIALIZATION EFFORTS
THROUGH POCTRN AND THE RADX
INITIATIVE AND WORKING IN
MEDICAL DEVICES OVER 30 YEARS
AND HOLDS OVER A DOZEN PATENTS
IN VARIOUS MEDICAL DEVICE AND
SUCCESSFULLY LED MEDICAL DEVICE
COMPANIES.
>> THANK YOU, TODD.
>> GOT IT.
THANK YOU, GREAT.
I'M A COMMERCIAL GUY AS I
MENTIONED EARLIER AS EVIDENCED
BY THE FACT I'M THE ONLY ONE ON
THE PODIUM NOT WEARING A TIE.
WHEN WE WERE TASKED IN THE EARLY
DAYS OF RADX TO ARCHITECT THE
SYSTEM THAT WOULD DELIVER THESE
BILLIONS OF TESTS, EVERY EVENING
MY WIFE WOULD SAY DO YOU THINK
YOU'RE GOING TO DO IT?
AND EVERY EVENING FOR MONTHS I
SAID NO WAY.
IT'S SUCH A HARD TASK.
SO MANY CONSTRAINTS, SO MANY
UNKNOWNS, SO MUCH INVENTION.
NOT ONLY INVENTION IN TERMS OF
THE TECHNOLOGY BUT INVENTION
FROM THE PROCESSES.
YOU HEARD THE EXPRESSION
BUILDING THE PLANE AS YOU'RE
FLYING IT.
WE WERE TRYING TO BUILD A PLANE
AS ITS CRASHING.
AS TODD MENTIONED, AFTER WE GOT
A FEW MONTHS INTO THIS AND
REALIZED THE SYSTEMS WE HAD IN
PLACE WERE WORKING WE WERE
PLEASANTLY SURPRISED.
MOST OF YOU HAVE SEEN THIS
FUNNEL.
THIS HAS ALMOST BECOME A
TRADEMARK FOR RADX TECH.
WHAT I'LL CONCENTRATE ON IS THIS
SECTION RIGHT THERE.
THE SHARK TANK SECTION WE CALL
DEEP DIVE IN THE PROGRAM.
THE REASON I'M INTERESTED IN
THAT IS BECAUSE I THINK NOW TWO
OR THREE YEARS LATER WE HAVE
ENOUGH DATA TO PROVE THAT THAT
WAS ONE OF THE MORE INNOVATIVE
THINGS RADX TECH DID AND IT'S
SOMETHING THAT'S PROBABLY
SCALABLE WITHOUT REQUIRING THE
LARGE AMOUNTS OF MONEY THAT RADX
HAVE.
A LOT OVERVIEW OF THIS.
THOSE WHO REVIEWED NIH GRANTS OR
WRITTEN NIH GRANTS YOU SPEND
WEEKS WORKING ON YOUR GRANT.
YOU PUT IT INTO THE PORTAL AND
THEN SPEND MONTHS WAITING FOR
SOME FEEDBACK AND THEN YOU GET
YOUR FEEDBACK AND AT LEAST IN MY
EXPERIENCE SOMETIMES I'M LIKE,
HUH, DID THE REVIEWERS ACTUALLY
READ THE APPLICATION?
OTHER TIMES IT WAS SPOT ON WITH
WEAKNESSES.
BUT MONTHS WENT BY AND AS A
SMALL BUSINESS PERSON MOST ALL
MY EXPERIENCE IS WITH SBIR
GRANTS THOSE MONTHS ARE
DIFFICULT FOR A SMALL BUSINESS.
YOU PROBABLY DON'T HAVE A LOT OF
FUNDING.
SO ONE OF THE THINGS WE WANTED
TO DO IN THE DEEP DIVE OR SHARK
TANK PROCESS WAS TRY TO CUT THAT
SHORT.
SO AFTER AN INITIAL RELIABILITY
REVIEW AND MAKE SURE IT WASN'T
PURE SCIENCE FICTION WE WOULD
ASSIGN A TEAM TO WORK WITH THE
APPLICANT TO REVIEW THEIR
APPLICATION IN A GREAT AMOUNT OF
DETAIL.
I'LL TALK MORE ABOUT THE REVIEW
TEAM AND TALK A LITTLE BIT ABOUT
THE WAY IT WAS REVIEWED.
BUT THE POINT OF THIS WAS TO
MAKE IT HAPPEN QUICKLY.
OUR OBJECTIVE WAS WITHIN A WEEK
THAT PRACTICALLY SOMETIMES WENT
TO TWO OR THREE WEEKS AND I
THINK MANY OF THE APPLICANTS
APPRECIATED IT BECAUSE IT WAS
VERY INTERACTIVE AND VERY -- I
WOULD LIKE TO THINK HELP FFUL W
HAD SOME EXPERIENCE PREVIOUSLY.
I'M GOING PUT A PLUG IN FOR THIS
SITE, GATES.org.
IT'S NOT BILL AND MELINDA GATES
AND I'D LIKE TO POINT OUT A FEW
POINTS OF THIS.
IT'S G-A-I-T-S AND IT MOVES
THROUGH IDEA, PROOF OF CONCEPT
TO STANDARD OF CARE.
IF YOU GO TO THE GAITS WEBSITE
IF YOU KWLIK IT WILL TAKE YOU TO
A COLLECTION OF CREATED %
RESOURCES, VIDEOS, ARTICLES HOW
TO ACCOMPLISH THE GOALS.
THERE'S TECHNOLOGY, REGULATORY,
MARKET AND CLINICAL, FOUR
DOMAINS.
NOT SURPRISINGLY THE
SOLICITATIONS THAT CAME OUT FOR
RADX SPECIFIED THOSE FOUR
DOMAINS.
THIS IS DIRECTLY CUT AND PASTED
FROM THE ORIGINAL SOLICITATION
WE WERE INTERESTED IN REVIEWING.
THESE WERE THE CRITERIA THAT THE
APPLICANTS WERE REVIEWED TO.
AND DEEP DIVE TEAM WOULD TAKE
THESE CRITERIA AND EVALUATE THE
APPLICATION RELATIVE TO THAT.
AND WHAT WE FOUND INTERESTING IS
SOMETIMES WE WOULD ASK THE
APPLICANT TO PLOT ON THE GAITS
WHEEL WHERE THEY THOUGHT THEY
WERE AND HAVE THE DEEP DIVE TEAM
DO AN ANALYSIS.
THIS IS AN EXAMPLE.
THE COMPANY THOUGHT THEY WERE
APPROVAL AND WE WON'T DISCLOSE
THE COMPANY.
AFTER A WEEK OR TWO OF DEEP
DIVE, THIS IS WHERE THEY WERE IN
REALITY.
THIS PARTICULAR GAITS WHEEL IS
INTERESTING BECAUSE THEY WERE
FAR ALONG IN THE COMMERCIAL SIDE
THAT WAS NOT TYPICAL.
MOST WERE FAR ALONG IN THE
TECHNICAL SECTION AND WEAKER IN
THE COMMERCIAL SECTOR.
BUT THIS COMPANY WAS QUITE FAR
ALONG FROM THE BUSINESS SIDE.
THIS IS AN EXAMPLE OF THE
SCRUTINY A DEEP DIVE TEAM CAN
GIVE TO AN APPLICATION.
IT'S NOT A CRITICISM.
WE WERE ALL LOOKING FOR THE MOST
PROBABILITY OF SUCCESS.
SO IT WAS A DISCUSSION AND 50%
OF THE TIMES COMPANIES THAT WENT
THROUGH THE DEEP DIVE IF THEY
PROGRESSED GOT MORE MONEY THAN
THEY ASKED FOR BECAUSE THEY WERE
SO FAR ALONG AND THE STUFF THAT
ISN'T FILLED OUT IN THE GAITS
WHEEL IS WORK TO BE DONE AND
DERISK THE PROJECT AND THAT
REQUIRED MONEY.
SO I THINK THE DEEP DIVE TEAMS
AND THE APPLICANTS TO DO THAT
DILIGENCE BENEFITTED FROM THIS.
A LITTLE BIT ABOUT THE TEAMS.
SO ERIC LAI WAS UP HERE EARLIER
AND A MEMBER OF THE TEAMS.
HEARD HIS IMPRESSIVE
CREDENTIALS.
THESE PHENOTYPIC OF THE PEOPLE
ON THE DEEP DIVE TEAMS.
THEY HAD OVER 30 YEARS OF
EXPERIENCE AND AN ADDITIONAL 20%
HAD OVER 20 YEARS EXPERIENCE.
REMEMBER, THIS IS 2020.
THESE PEOPLE ARE ALL SITTING AT
HOME LOOKING FOR SOMETHING TO DO
SO WHEN WE WERE CALLING AROUND
AND SUGGESTING IT WOULD BE FOUR
OR FIVE MONTHS, 20 HOURS A WEEK,
NO ONE SAID NO.
THAT WAS ONE OF THE UPLIFTING
PARTS OF THE COVID EXPERIENCE
FOR ME.
.
AGAIN, MOST HAD C LEVEL
EXPERIENCE.
MOST WERE ADD LEAST A VICE
PRESIDENT AND 45% HAD Ph.D.s AND
MANY WERE INVESTORS AND 16% WERE
FEMALE AND MANY STARTED
COMPANIES AND WE HAD THIS DREAM
TEAM.
THEY CAME TO BE KNOWN AS TEAM
AWESOME.
ONE OF THE SECRET -- NOT SO
SECRET, ERIC'S COMMENTS ARE
EVIDENCE, THEY DID DILIGENCE ON
THE COMPANIES AND IF THEY
SUGGESTED THE COMPANY ADVANCE,
THEN THE COMPANY BECAME THE
DILIGENCE TEAM'S PROBLEM AND OUR
TEAM LEADS WERE TASKED WITH
MAKING THE COMPANY SUCCESSFUL.
IF YOU'RE GOING TO RECOMMEND
THEM TO JOIN THE CLUB, IF YOU'RE
GOING TO RECOMMEND THEY GET THE
NIH DOLLARS MOVING OUT OF DEEP
DIVE, THEN THE SAME TEAM THAT
DID DILIGENCE WORKED INTIMATELY
WITH THE COMPANY OVER MONTHS OR
YEARS TO MAKE THEM SUCCESSFUL.
JUST A FEW DATA POINTS.
THE VAST MAJORITY OF COMPANIES
WERE SMALL BUSINESS AND
GENERALLY A SMALL BUSINESS WAS A
COMMERCIAL ENTITY WITH LESS THAN
50 EMPLOYEES OPPOSED TO A
START-UP WHICH WAS A SMALLER
ORGANIZATION AND PEOPLE HAVE
THROWN AROUND THE PRODUCE THE
BILLION TEST OR WHATEVER.
YOU COULD SEE THE RAMP UP THERE.
OUR ORIGINAL OBJECTIVE WAS
ABSURD NOW THAT I THINK ABOUT
IT.
TO HAVE ENOUGH TESTS FOR
EVERYBODY TO TEST BY THE END OF
THE SUMMER OF 2020.
JUST DO THE MATH AND THAT'S DIFF
TO IMAGINE AND OVER TIME THE
PROGRAM DID SHOW THE RAPID
ACCELERATION.
CAN'T MAKE A BABY IN LESS THAN
NINE MONTHS AND SOMETIMES YOU
CAN'T MAKE AN IVB IN LESS THAN
SIX MONTHS BUT ULTIMATELY THERE
A LONG TAIL.
LESSONS LEARNED.
I REALLY BELIEVE THE DEEP DIVE
PROCESS COULD BE A PARADIGM
SHIFT IN THE WAY FUNDING IS
DONE.
WE ALL BELIEVE IN THE PEER
REVIEW PROCESS FOR OUR PAPERS
AND OUR GRANTS AND THAT'S
IMPORTANT BUT IN TRANSLATIONAL
RESEARCH IF YOU CAN BRING PEOPLE
WHO ARE THE PEERS OF THE
ULTIMATE -- NOT THE INVENTOR
COMPANY BUT DISTRIBUTOR AND
BRING COMMERCIAL PEOPLE IN AND
HAVE THEM WORK AND HAVE THEM
HAVE A CONVERSATION WITH THE
APPLICANT RATHER THAN JUST
HAVING TO MAKE A DECISION BASED
ON 12 TO 60 PAGE GRANT
APPLICATION.
KICK THE TIRES A LITTLE BIT.
GET TO KNOW THEM.
FIGURE OUT STRENGTHS AND
WEAKNESSES.
TRY TO MITIGATE THE RISKS.
TRY TO REDUCE THE WEAKNESSES AND
EMPHASIZE THE STRENGTHS.
THAT'S WHAT THE VC COMMUNITY
DOES AND INVESTOR COMMUNITY
DOES.
AND I THINK FOR TRANSLATIONAL
GRANTS, THAT'S A PARADIGM THAT
WE SHOULD CONSIDER.
IT ISN'T APPLICABLE TO RESEARCH
OR THE INVENTION STAGE BUT THE
FOCUS IS ON HUMAN IMPACT AT THE
END OF THAT TAIL THEN I THINK
THIS IS A GOOD PARADIGM.
I TEACH AT M.I.T. AND THERE'S
THE M.I.T. IMPACT EQUATION FOR
THOSE THAT KNOW IT WHICH IS
IMPACT EQUALS INVENTION, TIMES
COMMERCIALIZATION.
AND IF EITHER INVENTION IS ZERO
OR COMMERCIALIZATION IS ZERO,
IMPACT IS ZERO.
SO NIH AND OTHERS HAVE DONE A
GREAT JOB OF THE PART AND
HOPEFULLY RADX WILL HELP FUND
THE COMMERCIALIZATION PART.
I'LL IT'S YOU A LITTLE BIT.
THERE'S UNPUBLISHED DATA THAT IS
THE RESULT OF THE FORCED
EXPERIMENT WE HAD.
WE WERE ABLE TO DO THIS
DILIGENCE ON ALL THE COMPANIES
AND THEN AS PART OF THE ONGOING
PROCESS NOT THE COMPANIES BUT
THE MEMBERS OF TEAM AWESOME WHO
ARE SUPPORTING THE COMPANIES
REPORTED OUT EVERY MONTH ON THE
COMPANY'S PROGRESS.
IN A FIXED WAY.
WE HAVE A UNIFORM WAY OF
INFORMING THE PROGRESS AND
ULTIMATELY KNOW THE SUCCESS OR
FAILURE.
SUCCESS IS DEFINED AS DID THEY
GET A COMMERCIAL PRODUCT OUT TO
TEST COVID?
WE'VE GONE BACK AND LOOKED
THROUGH THOSE DATA AND WE HAVE
FOUND AFTER THE TWO-WEEK DEEP
DIVE THERE'S A SET OF QUESTIONS
ASKED AND THE ULTIMATE SUCCESS
OR FAILURE OF 50% OF THE
COMPANIES COULD HAVE BEEN
PREDICTED AFTER THE FIRST TWO
WEEKS.
AND THE KEY TO THAT IS ASKING
CERTAIN QUESTIONS BUT HAVING
VERY EXPERIENCED UNBIASSED
MEMBERS OF A REVIEW TEAM ON THE
COMMERCIAL DIMENSION, REGULATORY
AND CLINICAL DIMENSION.
IF YOU LOOK AT THOSE THINGS AND
ASK THE RIGHT QUESTIONS IN THE
FIRST TWO WEEKS, ABOUT 25% OF
THE TIME YOU CAN PREDICT WITH
ALMOST CERTAINTY THE COMPANY
WILL FAIL.
25% OF THE TIME WITH ALMOST
CERTAINTY YOU CAN PREDICT
THEY'LL BE SUCCESSFUL AND 50% OF
THE TIME YOU CAN'T TELL.
EVEN STILL BEING ABLE TO DOUBLE
DOWN ON THOSE 25% YOU KNOW ARE
GOING TO BE SUCCESSFUL OR NOT
INVEST IN THE 25% YOU KNOW WILL
FAIL CAN MAKE A BIG DIFFERENCE
IN THE WAY WE'RE LOOKING AT
RESEARCH.
SO THIS WAS JUST THE SET UP.
HOPEFULLY WE'LL HAVE INTERACTION
AND SOME QUESTIONS.
AND WITH THAT I'LL TAKE IT BACK
TO TODD UNLESS YOU WANT ME TO
ENTERTAIN QUESTIONS NOW.
I FEEL LIKE TIFFANI THIS MORNING
UP AT 8:00 TRYING TO GET PEOPLE
TO FILL HALF AN HOUR.
>> THANKS, MIKE.
I APPRECIATE THE PRESENTATION.
MENTIONED YOU HAD COMMENTS WITH
REGARDS TO CONSTRAINTS AND
FUNDING AND BUDGETS AND YOU
MENTIONED THIS METHODOLOGY COULD
BE DEPLOYED IB A COST EFFECTIVE
OR NEUTRAL WAY.
AND THE COST OF BRINGING ALL
THAT FRAMEWORK TOGETHER.
>> SO I HAVE A BIAS HERE BUT MY
BIAS IS THAT THE DILIGENCE THE
DEEP DIVE NEEDS TO BE DONE BY
VERY EXPERIENCED COMMERCIAL
PEOPLE.
SO THAT MEANS RELATIVE TO
INVESTING MILLIONS TO PROGRAMS
THAT WILL BE FAILURES IT IS
INEXPENSIVE.
IN THE RADX WORLD A TYPICAL DEEP
DIVE COSTS ABOUT $10,000.
NOW, THAT WAS ALL OVER ZOOM.
THERE WEREN'T SITE VISITS WHICH
YOU MAY WANT TO THINK ABOUT IN
THE FUTURE BUT AT LEAST WITH THE
CONSTRAINTS WE HAD IN '20, '21,
'22, $10 ,000 YOU CAN DO A DEEP
DIVE.
SAY 100 COMPANIES APPLY AND 25
WILL OBVIOUS NOT A GOOD FIT.
YOU'VE GOT TO DO A DEEP DIVE ON
75 COMPANIES.
NOT ALL OF THOSE WILL PROGRESS
BUT STILL IN THE GRAND SCHEME OF
THINGS SEEMS TO BE SURE MONEY.
>> MY QUESTION IS WHETHER OR NOT
YOU COULD HAVE A CHECKLIST OF
NECESSARY BUT NOT SUFFICIENT
CRITERIA THAT DON'T GET ASKED
NECESSARILY BUT COULD BE SPECIAL
QUESTIONS THAT COULD IN AN RFA
FROM FUNDERS.
WOULD THERE BE PARTICULARLY
DISCERNING ONES IF YOU ASKED AS
A WRITTEN QUESTIONS COULD
POTENTIALLY BE INFORMATIVE?
>> YES.
SO WE OTHER ORIGINALLY STARTED
WITH 36 QUESTIONS IT'S DOWN TO
20 AND THERE ARE FOUR THAT ARE
QUITE PREDICTIVE.
BUT DR. MANABE, I'LL ASK YOU.
IF YOU'RE DIAGNOSING SOMEONE
I'LL SAY DO YOU FOLLOW A
CHECKLIST BUT DO YOU HAVE
CLINICAL JUDGMENT YOU'VE
DEVELOPED OVER TIME.
THE QUESTIONS NEED TO BE GIVEN
AND ASKED AND RECEIVED IN THE
CONTEXT OF SOMEONE WITH SOME
JUDGMENT.
I'LL BE SPECIFIC.
ONE OF THE QUESTIONS PREDICTIVE
IS DO YOU HAVE A SUSTAINABLE
VALUE PROPOSITION?
IS THERE ANY COMPANY THAT PLEASE
FOR THE SBIR GRANT WHO WON'T SAY
YES TO THAT?
IS THERE ANY COMPANY THAT
APPLIES THAT HAS IT WRITTEN OUT
AND HAS AN OFFSITE AND HAS NICE
WORDS ON IT BUT WHEN THE VALUE
PROPOSITION IS READ AND
SCRUTINIZED BY COMPANIES THAT
HAVE FAILED AND HOLES ARE POKED
IN IT.
THAT'S THE DIFFERENCE IN THE
CHECKLIST AND THE CHECKLIST
EXECUTED BY PEOPLE WITH DECADES
OF BUSINESS EXPERIENCE.
>> MARK PORTS FROM SALT LAKE
CITY.
WE WENT THROUGH THE DEEP DIVE
AND IT WAS A GREAT EXPERIENCE
FOR US.
IT FORCED US TO FIGURE OUT HOW
TO EXPLAIN THINGS CLEARLY AND
THE WHOLE PROCESS WAS VERY
USEFUL BUT I'VE ALSO GONE
THROUGH LOTS OF NIH GRANTS IN
PARTICULAR GRANT FOR DEVELOPMENT
OF FILM WRITING AT A PREVIOUS
COMPANY AND ONCE IT WAS FUNDED
THE PROGRAM OFFICER SORT OF LET
US TAKE IT AND TRY HARDER THINGS
AND WE HAD ENOUGH TIME IF IT
DIDN'T WORK TO GO BACK AND
THAT'S WHAT LED TO IT AND
MINDFUL OF THE METAPHOR FROM WAR
THAT NO BATTLE PLAN SURVIVES
FIRST ENCOUNTER WITH THE ENEMY.
THERE'S AN ASPECT WHICH I DO
STRUGGLE WITH WHICH IS WE'RE
GOING TO TRY ONE THING AND FIT
DOESN'T WORK WE'LL TRY ANOTHER
AND WE'RE ASKED TO DO HARD
THINGS.
SOMETIMES WE CAN'T TELL YOU
EXACTLY HOW IT'S GOING TO WORK.
>> RIGHT.
I WOULD AMPLIFY THAT.
YOU COULD NEVER EXPLAIN EXACTLY
HOW IT'S GOING TO WORK.
IF YOU AREN'T PIVOTING, IF
YOU'RE NOT IRRATIONALLY
PERSISTENT IN TRYING TO ACHIEVE
THE GOAL, YOU WILL NOT BE
SUCCESSFUL.
I WOULD ARGUE IN FACT THAT'S
PART OF THE BENEFIT OF THE
SYSTEM AND WHAT WE HAVEN'T
TALKED ABOUT IS THE ONGOING
SUPPORT.
HOPEFULLY JULIA OR WHOEVER YOUR
TEAM LEAD IS HAS BEEN SAYING ARE
YOU REALLY SURE THIS IS THE
RIGHT WAY TO DO IT OR TO ERIC'S
POINT, WE WANT TO MAKE A
MULTIPLEX TASK.
IT'S USEFUL TO HAVE A PARTNER TO
SAY YOU HAVE TO GO BACK.
YOU'RE DILUTION TOO GREAT AND GO
BACK AND REDO THE COVID TEST IN
THIS CASE.
YOU ALWAYS HAVE TO BE INVOLVED
BUT THAT COSTS MORE MONEY
BECAUSE THE DILIGENCE IS A
FAIRLY SHORT PERIOD OF TIME AND
THEN THE DOWNGOING SUPPORT COSTS
MONEY.
IT'S A TRADE-OFF ON HOW OFTEN OR
HOW FREQUENT OR HOW INTIMATE YOU
WANT THAT RELATIONSHIP TO BE.
>> AND THE DRAFT VERSION HAS
BEEN GREAT AND THEY'VE GIVEN US
THAT ROOM.
I THINK WE'RE ALMOST ALL BUMPING
UP INTO THE GOVERNMENT
CONTRACTING PROCESS WHERE WE MAY
HAVE DELIVERABLES WE HAVE TO
ADJUST AND THAT'S THE THING
WHERE YOU MAY GO THROUGH A
DIFFERENT PROCESS.
CHANGE OF MILLION.
>> RIGHT.
THANK YOU.
>> YOU HAD ON YOUR SLIDES A
STATEMENT NO THE AFFECT OF 50%
OF SUCCESS COULD BE PREDICTED.
FORGIVE ME IF I MISINTERPRETED
THAT.
IT APPLIES THERE'S A SUBSTANTIVE
NUMBER THAT COULDN'T BE
PREDICTED THEN.
>> THAT'S TRUE.
>> I WONDER IF YOU COULD COMMENT
IF THERE'S ANY GENERALITIES OR
THINGS THOSE COMPANIES OR
PROJECTS, WHATEVER, DID YOU
COULDN'T SEE IN ADVANCE THAT
MADE THEM SUCCESSFUL OR
SOMETHING LIKE THAT.
I DON'T KNOW IF THAT BY
DEFINITION MAKES IT PREDICTIVE
THEN.
>> SO LET ME ANSWER A QUESTION
I'M NOT SURE IS THE QUESTION
YOU'RE ASKING.
>> I'LL ASK AGAIN IF IT'S NOT.
>> THE WAY I VIEW IT IS LIKE A
TRAFFIC LIGHT.
THERE'S A GREEN, YELLOW AND RED
LIGHT.
IF IT'S A GREEN LIGHT YOU HAVE A
PRETTY A HIGH PROBABILITY THE
COMPANY WILL BE SUCCESSFUL.
ONE OF THE THINGS PREDICTIVE OF
THAT IS HAS THE COMPANY TALKED
TO THEIR ECONOMIC BUYER.
WHETHER THEY SUBMIT THE GRANT DO
THEY KNOW WHO IS GOING TO PAY
FOR WHATEVER THEY'RE BUILDING
AND WHAT THEY CARE ABOUT.
NOW, WE'VE HEARD THAT MANY
TIMES.
WE HEARD ABOUT CUSTOMER FOCUS
AND INVOLVING YOUR STAKEHOLDERS
EARLY ON.
AS YOU ALL KNOW IN HEALTH CARE,
WE HAVE QUITE A PERVERSE SYSTEM
IN THAT THE USERS OR ECONOMIC
BUYERS ARE NOT THE SAME GROUPS.
IT'S PREDICTIVE OF SUCCESS IF
THE COMPANIES IDENTIFIED WHO THE
ECONOMIC BUYER IS.
THAT IN AND OF ITSELF IS AMAZING
AND UNDERSTAND THE VALUE
PROPOSITION AND THE CONVERSE IS
TRUE.
COMPANIES THAT COME IN WITH A
PURE TECH PUSH PLAY I HAVE THIS
GIZMO AND ONCE I BUILD IT,
SOMEBODY WILL BUY IT, I'M SURE.
THEY TEND TO BE IN THE RIGHT
CATEGORY AND THE YELLOW LIGHT
MAYBE HAVE SOME OF THAT OR STILL
CUTTING EDGE WE BELIEVE THERE'S
SOMETHING REALLY COOL THERE BUT
SOMETIMES THEIR CUSTOMERS CAN'T
FIGURE IT OUT AND COULD GO
EITHER WAY.
>> LET ME PUSH ON THAT A LITTLE
BIT IF YOU DON'T MIND FOR ONE
SECOND.
ALL THOSE THINGS ARE PREDICTIVE
TO INFORMATION YOU WOULD HAVE AT
THE TIME.
AGAIN YOU'RE SAYING IT'S NOT
FULLY PREDICTIVE.
I'M WONDERING IF THERE'S
COMPANIES THAT MAYBE CAME THERE
AND FAILED WITH ALL THOSE THINGS
OR COMPANIES THAT MAYBE DIDN'T
HAVE THOSE THINGS BUT ULTIMATELY
SUCCEEDED.
>> ABSOLUTELY.
THIS IS DATA THAT WILL BE
PUBLISHED IN THE FUTURE BY SOME
PEOPLE IN THE ROOM BUT GENERALLY
SPEAKING, WHEN I SAY WITH NEAR
CERTAINTY THERE'S A 92
CONFIDENCE IT WILL BE IN THE
SUCCESSFUL SET.
IT'S NOT PERFECT BUT BETTER THAN
NOTHING.
>> THANK YOU FOR THE
PRESENTATION.
I APPRECIATE THE QUESTIONS.
GOOD DISCUSSION.
WE HEARD ABOUT THE FRONT END OF
TRANSLATION AND
COMMERCIALIZATION AS FAR AS
PICKING PROJECTS WE FEEL MAY
HAVE A GOOD CHANCE OF SUCCESS
BUT HOW DO YOU CONTINUALLY
EVALUATE PROGRESS AND ENSURE
THAT EFFICIENT PROGRESS IS BEING
MADE TO IT BE THE PROJECT OR
POSSIBLY PIVOT OR EXIT THE
PROJECT.
I'M PLEASED TO INTRODUCE OUR
NEXT SPEAKER IN THE PANEL TO
ADDRESS THIS.
JULIE SULLIVAN IS THE CHIEF
OPERATIONS OFFICER AT THE RADX
VALIDATION CENTER AT EMORY
UNIVERSITY.
SHE'S INVOLVED IN EVERY STEP OF
THE PROCESS FROM HELPING OB TABE
SAMPLE FOR LAB TESTING TO
COORDINATING TEST DELIVERIES TO
FIELD PRESENTATIONS AND
COORDINATION AND DISSEMINATION
AND KEEPS THE ACCELERATED PACE
OF DISSEMINATION AND GRATEFUL TO
HAVE HER WITH US TODAY.
>> GOOD MORNING.
THANK YOU, TODD FOR THE
INVITATION TO SPEAK TODAY AND
THANK YOU ALL FOR BEING HERE.
EMORY WE'RE THE ATLANTA CENTER
FOR POINT-OF-CARE TECHNOLOGIES
BASED IN ATLANTA AND A
COMBINATION OF CHILDREN'S HEALTH
CARE ATLANTA THE LARGEST HEALTH
SYSTEM IN THE SOUTHEAST UNITED
STATES AND GEORGIA AND EMORY AND
A U54 CENTER STARTED IN 2018 OUR
CENTER WAS TASKED WITH
EVALUATING THE TEST.
SOMETIMES CALLED VERIFICATION
AND SOMETIMES VALIDATION AND
THOSE IN THE REGULATORY
LANDSCAPE YOU KNOW THOSE ARE
DIFFERENT MEANS.
I LIKE TO SAY WE KICK THE TIRES
AND SEE HOW WELL DO THEY WORK.
HOW DO WE TEST THE COVID TEST?
WE TESTED IN MULTIPLE FACETS THE
DRIVE-THROUGH TESTING SITE.
DID YOU DRIVE-THROUGH ONE DURING
THE PANDEMIC?
THE LINE WAS A MILE LONG.
THIS WAS AN OPPORTUNITY TO
CAPTURE INDIVIDUALS COMING FOR
TESTING, OBTAIN VERY NEEDED
CLINICAL SAMPLES AND/OR TEST AS
WE MOVED INTO MORE OF THE
OVER-THE-COUNTER TESTS.
THIS WAS AN OPPORTUNITY TO HAVE
THE INDIVIDUALS PROSPECTIVELY
TEST AND EVALUATE BY HAVING THE
CLINICAL TEAMS BOTH FROM
PEDIATRICS AND ADULT SIDE AND
HAVING THEM ABLE TO BE MOBILE WE
WERE ACTUALLY ABLE TO MOVE TO
RURAL AREAS OF THE STATE AND BE
ABLE TO A, OFFER TESTING WHEN
THERE WERE SURGES AND THE HEALTH
SYSTEMS THERE WERE SO
OVERWHELMED AND ENROLL IN
RESEARCH.
OUR LAB TRIES MENTIONING THE
NEED TO COLLABORATE AND YOU'LL
SEE THE CHIEF PATHOLOGIST AND
THE ABILITY FOR THAT TEAM TO BE
INVOLVED IN VALIDATING THE TEST
AND BIO SAFETY LEVEL 2 AND 3
LABORATORIES.
YOU HEARD ABOUT THE WORK DONE
AND IN THE LEFT HAND CORNER
GEORGIA TECH AND A COMPANY
REFERRED TO AS HOME LAB,
USABILITY AND HUMAN FACTORS
GROUP TO LOOK AT THE TESTS AND
SEE HOW PEOPLE ARE DOING WITH
THEM.
CAN THEY FUNCTION WITH THIS
TEST.
I HAVE ONE IN MY POCKET HERE.
HAS ANYONE SEEN THE AZURE PEN
WITH EMERGENCY USE
AUTHORIZATION?
THIS CAME TO OUR CENTER A FEW
TIMES AND WE IN ATLANTA LIKE TO
BREAK THINGS APPARENTLY AND
FOLKS WOULD TAKE IT A PART AND
DIDN'T UNDERSTAND.
THE COMPANY WAS ABLE TO ADD
LABELLING SO PEOPLE COULD
SUCCESSFULLY UTILIZE THE TEST.
HOW MANY HAVE HAD INVOLVEMENT
WITH OUR CENTER IN SOME WAY,
SHAPE OR FORM?
QUITE A FEW OF US.
IMPORTANTLY THE NEW YORK TIMES
DID A PIECE ON US IN 2022
TALKING ABOUT HOW WE TESTED THE
TEST.
THIS WAS AGAIN LOOKING AT SOME
OF THE OVER THE COUNTER TESTS.
PEOPLE AT THE DRIVE-THRU TESTING
THEMSELVES WITH A LATERAL FLOW
ASSAY IN THEIR CARS.
WE HAVE AN INCREDIBLE TEAM WITH
OUR LABORATORIES WITH OUR
CLINICIANS AND WITH OUR FACULTY.
A HUGE ENDEAVOR AND PEOPLE WHO
ARE SO PASSIONATE ABOUT THIS
WORK AND THIS PIECE IN THE NEW
YORK TIMES WAS A GREAT WAY TO
HIGHLIGHT SOME OF THAT WORK.
SO HAVING THE INFRASTRUCTURE SET
UP WE'VE BEEN WELL POISED TO
REACT TO THINGS WHEN IF IT'S
TODD OR SOMEBODY, ERIC LAI SAID
FDA IS FREAKING OUT BECAUSE
THERE'S A NEW VARIANT.
CAN YOU TEST AND/OR RE-TEST
TESTS WITH CERTAIN VARIANTS?
WE WERE ABLE TO DO JUST THAT.
THE SEQUENCING PROVIDED
VALIDATING AN EVALUATING THE
TESTS AND THEN AGAIN THE
SCANNING OR EPITOPE MAPPING FDA
IS NOW ASKING THE LATERAL LOW
ASSAY COMPANIES DO AND HAVE THE
BIO CHEMISTRY DEPARTMENT ABLE TO
PROVIDE THAT SERVICE.
YES, I JUST TOOK A PHOTO
YESTERDAY OF DR. TROMBERG
MENTIONING US SO IT'S BEST
PRACTICE.
HAVING THE ECO SYSTEM SET UP AND
READY TO DO THINGS ENABLED US TO
DO THIS CREATING OF THIS
NEGATIVE SWAB MATRIX.
THE SIX PLUS LITERS WHERE MANY
OF US NOT ONLY -- I'M NOT JUST A
MEMBER BUT CLIENT TOO.
WE SWABBED OUR NOSES TO PUT OUR
SWAB INTO SALINE AND POOLED TO
CREATE OVER SIX LETERS IN FIVE
WEEKS TIME AND NOWING WE CAN NOW
REACT AND HELP IN THAT WAY.
OUR INFRASTRUCTURE IS BIG.
14 LABORATORIES IN SEVEN
LOCATIONS THROUGHOUT THE METRO
ATLANTIC AREA.
OVER 25,000 ADULT AND PEDIATRIC
BIO SAYS MENS, OVER 14,000
INVOLVED IN RESEARCH SINCE WE
SET UP THE IRB IN THE SUMMER OF
2020.
INTERESTINGLY IN THE MIDDLE
YOU'LL SEE DIVERSE POPULATIONS
WE'VE BEEN ABLE TO ENROLL.
WE HAVE A TERTIARY SYSTEM
ENROLLING PEOPLE WHO DO NOT HAVE
A HIGH SCHOOL EDUCATION AND WHEN
YOU TALK ABOUT FOLLOWING A QRI
ON A LATERAL FLOW ASSAY OR AT
HOME, ARE THEY ABLE TO FOLLOW
THOSE INSTRUCTIONS?
WHAT ARE THE CHALLENGES THOSE
SUBJECTS MIGHT EXPERIENCE IN
TRYING TO CONDUCT AN AT-HOME
TEST?
ALMOST EVERY TEST HAS COME TO US
AND HAVE BEEN ABLE TO SHIFT TO
WHAT COMPANIES CAN USE IN THE
EARLY STAGES TO VERIFY AND
VALIDATE.
I SEE WE WERE ABLE TO SEND DRY
SWABS TO SOME TO WORK THROUGH
THEIR CLINICAL STUDY FOR THEIR
ASSAY.
IN THE McDONALD YOU SEE THE
DIAGNOSTIC FOCUS AREAS.
NOT JUST COVID.
YOU SEE TAKING THE RADX AND ITAP
MODEL AND WE'VE BEEN EVALUATING
AND ASSESSING THE MULTIPLEX.
THE COVID-19, FLU A AND B AND M
POX AND HEPATITIS C.
WHILE THEY'RE DIFFERENT CLINICAL
GROUPS IN MANY CASES LABORATORY
ARE ABLE TO STEP IN.
AND OUR CENTER IN ATLANTA ERIC
TALKED ABOUT SOME PROJECTS BEING
LIKE AN UGLY BABY.
WE'RE LIKE THE MIRROR.
WE PROVIDE THE DATA AND
INFORMATION AND FEEDBACK BUT
ULTIMATELY WE LET THE NIH MAKE
THE DECISION ABOUT WHETHER TO
MOVE FORWARD WITH SOMETHING AND
WHAT THE TRAJECTORY MIGHT BE.
A FEW LESSONS LEARNED, AGAIN OUR
KICKING THE TIRES, TESTING THE
TEST.
WE WERE ABLE TO QUICKLY ANSWER
FOR TEAM AWESOME AND MIKE
DEMPSEY AND SAY HERE'S WHAT THE
LOD VERIFICATION DATA LOOKS LIKE
FROM US.
HERE IS WHAT WE SAW FROM OUR
PROSPECTIVE FIELD STUDIES.
EIGHT OF FALSE POSITIVES AND
NEGATIVES AND WHAT'S THAT LOOK
LIKE.
DOES IT WORK AT ALL?
SOMETIMES IT SOUNDS TOO GOOD TO
BE TRUE AND SOMETIMES TEAM
AWESOME WOULD SAY CAN YOU
EVALUATE THIS FOR US AND GIVE US
QUICK DATA SO WE CAN MAKE OUR
DECISIONS?
HOW WELL DOES THIS TEST WORK
COMPARED TO OTHER TESTS AS YOU
SAW FROM DR. RAO WITH THE
BOOKEND ASSAYS AND BEING ABLE TO
COMPARE APPLES TO APPLES ACROSS
THE ASSAYS AND THE USABILITY AND
HUMAN FACTORS.
CANNOT DISCOUNT THAT AT ALL IN
HOW IMPORTANT THAT'S BEEN WITH
THE TESTS.
AND AGAIN HAVING THIS
INFRASTRUCTURE AND ECO SYSTEM AT
THE READY AND THE FIRST TEST
THAT CAME TO US IN RADX WAS ONE
WHERE IS IT TOO GOOD TO BE TRUE
JUNE OF 2020 AND ONE SCIENTI ST
LAB TO MIDNIGHT TO SEE IF IT
WOULD WORK.
WILL THIS BE AN ANSWER TO
PROVIDE TEST FOR THE REST OF THE
COUNTRY.
OUR CENTER WAS FOUND IN PART
WITH OLIVER BRANT ONE OF OUR
P.I.s WHO PASSED AWAY SUDDENLY
THIS PAST SPRING AND JUST A
MEMORY OF OLIVER.
HAPPY TO ANSWER ANY QUESTIONS
FROM ANYONE TODAY.
THANK YOU.
>> THANK YOU SO MUCH, TODD.
SO NOW WE'RE GOING TO MOVE TO
OUR DISTINGUISHED PANEL NUMBER
SIX.
THIS WILL BE CHAIRED BY ROBERT
MURPHY AND IT'S ENTITLED
POINT-OF-CARE TECHNOLOGY AND
INNOVATIONS AND TRANSLATION AND
LOW RESOURCE SETTINGS.
THANK YOU.
>> GOOD MORNING, EVERYONE.
SO I THINK YOU ALREADY MET THESE
PANELISTS YESTERDAY EXCEPT FOR
ME.
AND WHILE THEY'RE TAKING THEIR
SEATS I'LL INTRODUCE MYSELF.
I'M ROB MURPHY AT THE
NORTHWESTERN C FAN CENTER AND
ONE OF THE P.I.s THERE GOING
INTO THE SECOND CYCLE.
THE OTHER P.I.s YOU MET
YESTERDAY, CHAD AUCHENBACH AND
I'LL START OFF AND INTRODUCE YOU
GUYS AGAIN AND MENTION YOUR
NAMES, DEREK ERICKSON AND YUKA
MANABE YOU HAVE BEEN THE MOST
PANELS AT JOHNS HOPKINS AND REB
BECCA KORCUM AND HERE ABOUT THE
GLOBAL EFFORTS.
YOU MET THE PANELISTS.
THESE ARE A FEW INTRODUCTORY
REMARKS.
WHEN WE STARTED ABOUT SIX YEARS
AGO WAS THE THIRD CYCLE.
IT WAS HOPKINS, UNIVERSITY OF
MASSACHUSETTS, EMORY AND
NORTHWESTERN AND WE HAD A COUPLE
MEETINGS.
EVERYONE'S VERY FRIENDLY AND WE
WERE IN ONE OF THOSE ROOMS ON
THE OTHER SIDE OF THE CORNER
HERE AND WERE SILOED.
WE INTERACTED JUST WITH THE
PROGRAM OFFICERS AND WE DID OUR
THING AND EVERYTHING WAS HAPPY
AND ALONG COMES COVID.
APRIL 29, 2020, DR. TROMBERG WAS
ASKED BY THE HEAD OF NIH TO GET
MOVING WITH THE DIAGNOSTICS FOR
CORONAVIRUS.
AND SENATE GOT INVOLVED AND WE
ALL PARTICIPATE D AND HAD A
RADICAL CHANGE IN THE STRUCTURE
AND FROM THE CENTER POINT OF
VIEW WE WENT FROM THE SILOS TO
THE COMPLETELY INTEGRATED
NETWORK AND AMAZING HOW QUICKLY
IT INTEGRATED AND ALL OF A
SUDDEN WHILE WORKING TOGETHER.
I'VE NEVER SEEN A SCIENTIFIC
GROUP GET TOGETHER THAT QUICKLY.
IT WAS A PANDEMIC AND EMERGENCY
BUT EVERYBODY STEPPED TO THE
PLATE AND IT'S BEEN AN AMAZING
EXPERIENCE.
HOW WE'RE IN THE PLUS PHASE AND
THERE'S TWO NEW SITES.
TWO LEADS ARE SITTING WITH ME
HERE.
WE'VE GONE FROM 1.5 GLOBAL
CENTERS HOPKINS IS .5 BECAUSE
YOU WERE A BIT IN THE U.S. AND A
BIT IN UGANDA AND THE OTHER SITE
ALL SUB-SAHARAN SOUTH AFRICA AND
HAVE TAKEN A HUGE SHIFT IN THE
GLOBAL SPHERE.
WE ALSO CHANGED OUR FOCUS FROM
IMPORTANT BUT INCREMENTAL
PRODUCT DEVELOPMENT TO RAPID.
55, EUAs, 8 BILLION TESTS,
POINT-OF-CARE PCRs TO THE FIRST
OVER THE COUNTER TEST AND
MULTIPLEX WITH THE FLU ALL DONE
WITH THIS GROUP.
WE'VE BEEN ABLE TO EXPAND THE
PLATFORM -- WE TALKED ABOUT
YESTERDAY IN ONE THE SESSION TO
M POX AND MATERNAL FETAL ISSUES
AND NEUROLOGY AND THE HIV VIRAL
LOAD POINT-OF-CARE PROJECT.
IT'S BEEN VERY QUICK AND RAPID
CHANGE.
SO WHY GLOBAL?
THE LOW AND MIDDLE INCOME NEEDS
I THINK EVERYONE WOULD AGREE ARE
GREATER THAN THE HIGH-INCOME
COUNTRIES AND GROWING.
THEY'RE GROWING IN NEED BUT IN
SIZE AND THE ONLY CONTINENT THAT
WILL DECREASE IS AFRICA.
IF YOU LOOK AT THE NUMBERS
AFRICA WILL DOUBLE IN POPULATION
GOING FROM 1.4 BILLION TO OVER
2.5 BILLION PEOPLE.
THEY HAVE A VERY ROBUST GROWTH
RATE GOING ON FOR A VARIETY OF
REASONS.
THEY STILL HAVE A LOT OF
CHILDREN AND THE CHILDREN ARE
HEALTHIER AND VACCINE MORE.
VACCINATIONS ARE MORE AND
REBECCA WILL ADDRESS THE NEST
PROJECT.
THE ACTION IS HAPPENING THERE.
EUROPE WILL LOSE A SIGNIFICANT
PROPORTION OF THE POPULATION
OVER 100 MILLION PEOPLE LESS.
SOUTH AMERICA AND NORTH AMERICA
AND ASIA THERE'S A BROAD RANGE
OF EXPECTATIONS IN TERMS OF
POPULATION AND WITH THE MIDDLE
SOME WILL BE LOSING POPULATION
AND CHINA'S BIRTH RATE IS 1.2
AFTER THEY STOPPED THE CHILD
POLICY.
YOU NEED 2. 2 MAINTAIN AND
CHINA WILL BE THE BIG PLAYER TO
DECREASE AND JAPAN HAS LITTLE
IMMIGRATION AND INDIA WILL BE
THE BIG GROWER BUT LEVELLING OFF
THE ONLY CONTINENT IS AFRICA.
THAT WILL NEVER BE THE
LABORATORY INFRASTRUCTURE IN THE
LOW-INCOME COUNTRIES LIKE WE
HAVE IN THE HIGH.
IT'S NEVER GOING TO HAPPEN.
IT'S LIKE LAND LINE AND
TELEPHONES.
THERE WERE FEW IN AFRICA AND
STILL FEW AND THEY HAVE MORE
CELL PHONES THAN WE HAVE.
YOU DON'T NEED LAND LIBES.
-- LANDLINES.
PART OF THE REASON ARE THE
HIGH-INCOME COUNTRIES WE DON'T
HAVE A STRONG A NEED TO BE MORE
EFFICIENT, MORE COST EFFECTIVE
TO HAVE MORE POINT OF CARE.
THERE'S DISINCENTIVE FOR OVER
THE COUNTER TESTING.
I SPONSORED A WEDDING AT MY OWN
HOUSE AT THE END OF THE SUMMER.
THE BRIDE GETS COVID THE NIGHT
BEFORE.
I RUN OUT AND GET TESTS.
WE REARRANGE EVERYTHING OUTSIDE
AND SHE GOT PAXLOVID AND THE
INSURANCE DIDN'T COVER ONE TEST
OVER THE COUNTER AND I BOUGHT 20
TESTS IT COST $400.
THAT'S JUST NOT GOING TO HAPPEN
IN THIS WORLD.
WE'VE GOT TO FIGURE OUT OTHER
WAYS TO KEEP IT GOING HERE.
I WANT SOME TESTS.
YOUR INSURANCE PAYS.
IF YOU DON'T HAVE INSURANCE YOU
PAY CASH.
10 TESTS, 12 EUROS.
IT'S A DIFFERENT SET UP HERE.
THERE'S SOMETHING WRONG IN THE
STRUCTURE IN THE WAY WE ARE
APPROACHING PUBLIC HEALTH IN THE
WAY THAT WITH YOU SET UP THIS
MORNING.
IN THE LOW-INCOME COUNTRIES,
CURRENT SITUATION REALLY
ENCOURAGING GREATER CREATIVITY
TO DEVELOP EASIER TO USE OTC
TESTS.
THAT'S JUST ONE INSTANCE.
OUR TECHNOLOGIES ARE EXPENSIVE.
EVEN OUR OVER THE COUNTER
TECHNOLOGIES ARE EXPENSIVE.
THERE'S INEQUITABLE
INFRASTRUCTURE AND DISPARITIES
IN HEALTH CARE.
THE UNITED STATES HAS THE WORSE
HEALTH CARE METRICS OF THE TOP
HIGH INCOME COUNTRIES IF YOU
LOOK AT LIFE SPAN, MATERNAL
MORTALITY AND LOOKING AT COVID
SURVIVAL, WE DO THE WORSE OF OUR
PEER COUNTRIES.
THE LIFE SPAN FOR MEN IS
ESTIMATED FOR 2023, 73 YEARS.
FOR WOMEN IT'S 79.
THAT'S 20 OF 20 FROM THE
HIGH-INCOME PEER COUNTRIES AND
YOU CAN SEE ON THE GRAPH HERE
THE LIFE EXPECTANCY PEER
COUNTRIES IN THE BLUE AND UNITED
STATES IS THE GREEN.
OUR LIFE EXPECTANCY IS DECLINING
AND OTHER COUNTRIES HAD A DEP
FROM COVID BUT RECOVERING.
TOP BLUE.
IN THE UNITED STATES THE LIFE
EXPECTANCY CONTINUED TO GO DOWN.
IT WAS MENTIONED YESTERDAY IN
THE MATERNAL FETAL MORTALITY
SESSION WE HAVE THE WORSE
OUTCOMES IN THE HIGH-INCOME
COUNTRIES.
FOR COVID SURVIVAL WE'RE 20 OF
20.
THERE'S ONLY ONE OTHER HIGH
INCOME COUNTRY THAT DID WORSE
THAN US AND THAT WAS SLOVAKIA.
A COUNTRY OF 5 MILLION PEOPLE IN
CENTRAL EUROPE.
THAT'S IT.
EVERYBODY ELSE DID BETTER THAN
US.
THE SAN FRANCISCO BAY AREA CAN
THE BEST AND YOU GO TO
MISSISSIPPI AND FLORIDA AND
OTHER STATES IT'S AS HIGH AS 600
DEATHS.
THAT'S AN ENORMOUS DIFFERENCE IN
OUR COUNTRY.
WE HAVE A WAY TO GO.
WHAT DO WE KNOW ABOUT THE
TECHNOLOGY AND THEN I'LL TURN IT
OVER TO OUR PANEL HERE, THERE'S
A WIDE DISPARITY IN AFRICA.
AFRICA IS A HUGE CONTINENT AND
IF YOU LOOK AT LIFE EXPECTANCY,
CHAD HAS THE WORSE IN THE, 53.68
YEARS.
SENEGAL HAS THE BEST.
69.
ALMOST THE WORLD AVERAGE WHICH
IS 7.
THE BIOMEDICAL ENGINEERING FIELD
STARTED THERE IN THE 1960s AT
THE UNIVERSITY OF CAPE TOWN WITH
THE FIRST HEART TRANSPLANT WAS
PERFORMED IN THE WORLD AND DID
THE FIRST TECHNOLOGY THOUGH THEY
DIDN'T INVENT THE FIRST SCANNER
THE TECHNOLOGY BEGAN AT
UNIVERSITY OF CAPE TOWN BACK IN
'60s.
THERE'S A LOT MORE ADVANCED AND
YOU'LL BE HEARING FROM THE
PANELISTS AS WELL TO BACK ME UP
HERE BUT THERE ARE A LOT OF
THINGS GOING ON SOLID AND GOOD.
OMICRON.
IT'S STILL THE VARIANT OF CHOICE
THESE DAYS.
IT WAS FIRST IDENTIFIED IN
BOTSWANA AND CONFIRMED IN SOUTH
AFRICA.
LOOK AT EBOLA.
IT WAS AN EPIDEMIC.
IT DIDN'T BECOME A PANDEMIC AND
PRIMARILY WAS LIMITED TO THREE
OF POOREST COUNTRIES IN AFRICA.
LIBERIA AND SIERRA LEONE.
IT DIDN'T SPREAD.
WHY DIDN'T IT SPREAD?
THEY CONTROLLED IT.
THEY COULD CONTROL IT.
POHLIO -- POLIO HAS BEEN
ERADICATE AND AFTER EBOLA AFRICA
SET UP THEIR OWN CDC AND THEIR
OWN BIO ENGINEERING CONSORTIUM
WHICH IS SOMETHING WE SHOULD BE
WORKING MORE CLOSELY WITH.
IT'S AT EARLY STAGES.
WE HELP IN THE EFFORT THROUGH
FUNDING AND THAT'S A START AND
THE THREE BIG DEPARTMENTS IN
SOUTH AFRICA, CAPE TOWN AND
OTHERS ARE ALL INVOLVED AND
EXPANDING THEIR CAPACITY.
THEY HAVE TREMENDOUS POTENTIAL
AND THE UNIVERSITY PARTICIPATED
IN THE RADX PROGRAM.
RADX WAS ALL U.S. BASED BUT
STONEBASH CAME ON BOARD AT THE
END IN A BIO REPOSITORY PROGRAM
SO WE HAVE SPECIMENS IN OUR BIO
REPOSITORIES FROM THERE NOW.
SO EFFORTS HAVE BEEN ROBUST FOR
THOSE AND THE OTHERS AND AFRICA
HAS ITS OWN BIOMEDICAL TEXTBOOK
FUND THE FOGARTY AND THE EDITOR
AND CHIEF WAS FROM THE
UNIVERSITY OF CAPE TOWN.
THAT'S THE END OF MY
INTRODUCTORY COMMENTS.
WE'LL START WITH DAVID.
COME HERE BECAUSE YOU HAVE
SLIDES.
SOME HAVE SLIDES AND SOME DON'T.
>> THANK YOU FOR THE OPPORTUNITY
TO SPEAK HERE TODAY AND FOR THE
OPPORTUNITY TO BE PART OF THIS
FANTASTIC NETWORK.
I SPOKE YESTERDAY ABOUT OUR NEW
CENTER WHICH YOU CAN SEE HERE
AGAIN DURING VARIATION SESSIONS.
I'D RATHER SPEND MY FIVE MINUTES
IN TRANSLATION LEARNED IN
LIMITED RESOURCE SETTINGS AND
THOUGHT I'D DO THAT AROUND TWO
EXAMPLES.
THE FIRST ONE HERE AND I'M NOT
GOING TO TALK TOO MUCH ABOUT
TECHNOLOGY OR TALK ABOUT
REQUIREMENTS OR THAT SORT OF
THING.
JUST AGAIN MORE LEARNINGS THAN
ANYTHING.
FIRST THING WE DEVELOPED A
POINT-OF-CARE DIAGNOSIS FOR A
TYPE KAPOSI SARCOMA AND
ILLUSTRATIVE OF THE KIND OF
THINGS PEOPLE MAY WANT TO THINK
ABOUT AS YOU'RE CONSIDERING WHAT
LEARNINGS WE CAN DO AND HOPE WE
CAN TAKE THE LEARNINGS AND DO
BETTER IN OUR CENTER.
OFTEN A GOOD EFFORT BEGINS WITH
A GOOD IDEA AND A GOOD SOLUTION.
ULTIMATELY THAT INVOLVES DESIGN.
I'M MECHANICAL ENGINEER.
WHAT I WOULD SAY IS IT'S VERY
EASY TO INVENT SOMETHING.
IT'S VERY HARD TO INVENT
SOMETHING USEFUL.
THE DIFFERENCE BETWEEN THE TWO
IS THE MORE YOU UNDERSTAND ABOUT
THE PROBLEM WHEN YOU START.
OFTEN WE HAVE AN IDEA AND HAVE A
GOOD WAY TO SOLVE IT AND ONE OF
THE THINGS THAT COULD BE BETTER
UNDERSTOOD NOW UP FRONT IN A LOT
OF THESE PROJECTS IS BETTER
UNDERSTANDING THINGS LIKE THE
REGULATORY ENVIRONMENT AND ALL
THESE THINGS EARLIER ON.
LIKE IT'S AN PROBLEM IN AN
ACADEMIC ENVIRONMENT AND
INCENTIVE TO GET IT QUICK BUT
HOPE WE CAN DO MORE EARLY UPON
THOSE ARE THINGS THAT INCLUDE
TECHNOLOGY CONSTRAINTS LIKE
HAVING TO DEAL WITH BROWN OUTS
AND THESE THINGS AND DUST AND
USERS AND THOSE SORTS OF THINGS.
BUT PROBABLY MORE THAN THOSE
TECHNICAL CONSTRAINTS, WHO DO
YOU HAVE TO CONVINCE TO USE IT.
WHAT IS THE EXISTING FRAMEWORK
FOR THIS LOOKS LIKE AND WHAT ARE
THE CHALLENGES YOU'LL HAVE TO
LOOK AFTER?
THE INNOVATIVE TECHNOLOGY THAT
FITS THAT IDEA.
GOOD PARTNERS THAT CAN HELP I
UNDERSTAND BOTH HOW TO ADDRESS
THOSE PROBLEMS EARLY ON AND TO
IMPLEMENT AND GET BUY IN FROM
THE PEOPLE YOU NEED TO USE.
GREAT PARTNERS IS IMPORTANT.
EXTENSIVE VALIDATION AND GOOD
PARTNERS THAT CAN DO IT AT SCALE
AND BROAD DEPLOYMENT AS MUCH AS
POSSIBLE.
ONE OF THE THINGS HELPFUL FOR US
IS HAVING ACCESS TO A NETWORK
THAT'S PARTICULARLY BROAD BOTH
IN TERMS OF GETTING A BROUGHT
PERSPECTIVE OF USERS IN
DIFFERENT LOCATIONS AND ALSO
GETTING BUY-IN FROM THOSE WE
HOPE TO EVENTUALLY USE IT.
ALMOST A FORM OF ADVERTISING IN
A SENSE OR AWARENESS BUILDING
AROUND WHAT WE'RE TRYING TO DO.
AND NUTRITION TESTING AROUND
IRON AND WITH BROAD DEPLOYMENT
OF MOBILE PHONES AVAILABLE IN
DIFFERENT PLACES WHERE OTHER
TECHNOLOGIES AREN'T AND USE
THOSE AS MECHANISM TO DO
NUTRITIONAL TESTING AND IRON
STATUS DEFICIENCY TESTING AND
UNDERSTANDING WHAT'S CHANGED AND
WHAT MAY BE A NOVEL IDEA AND
FINDING INVESTMENT PARTNERS THAT
WILL BUY INTO THAT VISION THAT
THIS WILL WORK IN THE DIFFERENT
ENVIRONMENT AND COMBINATION OF
COMMERCIAL AND GOVERNMENT
PARTNERS THAT CAN PROVIDE
FUNDING TO DEPLOY WHEN POSSIBLE.
TO GO INTO THOSE AGAIN.
JUST A FEW COUPLE OTHER SLIDES
AGAIN FOCUSSING MORE ON THE
EFFORT THE ABILITY TO WORK
ACROSS EVERYTHING REQUIRED.
ENGINEERING AND IN THIS CASE,
MORPHOLOGY, DERMATOLOGY,
EPIDEMIOLOGY.
IT'S IMPOSSIBLE FOR ONE PERSON
TO BUILD UP A NETWORK LIKE THIS
BY THEMSELVES.
FINDING PEOPLE TO HELPED BUILD
THOSE NETWORKS IN THE PAST AND
WORKING WITH THEM TO UNDERSTAND
HOW YOUR TECHNOLOGY AND SO FORTH
MIGHT BE APPLICABLE OR AWARE
THEY'RE APPLICABLE.
AND WORKING CONTINUOUS EVOLUTION
AND ALL THE STAKEHOLDERS.
THAT'S THE POTENTIAL USERS AND
SITES AND THE LOCAL TECHNOLOGY
AND MAKE THE POINT ABOUT
MULTI-SITE NETWORK AND TAKING
ADVANTAGE OF NETWORKS THAT
ALREADY EXIST.
THIS PARTICULAR ONE WAS BUILT BY
MY GOOD COLLEAGUES WHO MANY OF
YOU KNOW HERE WE'VE BEEN ABLE TO
SUPPORT THE DEVELOPMENT OF THIS
TECHNOLOGY ACROSS A BROAD RANGE
OF USERS AND COUNTRIES GIVING US
FEEDBACK WE KCAN PUT BACK IN TH
DESIGN AND ULTIMATE TRANSLATION.
THAT'S MY FIVE MINUTES.
>> I FOUND CAPABILITY IN SOME
AREAS AND THE GAPS IS WHAT YOU
HAVE TO DESIGN.
ONCE YOU UNDERSTOOD THOSE GAPS
YOU CAN START TO MAKE IMPACT.
WE SPENT TIME INITIALLY FIGURING
OUT THE EPIDEMIOLOGY OF SEXUALLY
TRANSMITTED INFECTIONS AND
FIGURING OUT HOW TO IMPACTFULLY
USE THEM AND WE WENT TO GAMING
CENTERS WHERE PEOPLE WERE
BETTING ON PREMIERE GAMES AND
FOUND MEN WERE LARGELY PART OF
THE PROBLEM.
IT WAS INTERESTING TO FIND OUT
MEN HAVE A LOT OF SYPHILIS BUT
NOT YET HIV.
AND WE FOUND OUT FOR THOSE
INTERESTED IN TESTING YOUR STD
DIAGNOSTICS THAT IF YOU TOOK MEN
WITH A DRIP A PERCENTAGE HAVE
GONORRHEA AND IF YOU LOOK AT
POPULATIONS IN UGANDA YOU COULD
QUICKLY GET POSITIVES AND NOT
HAVE TO RECRUIT AS MANY AS
PEOPLE AND ESPECIALLY IF YOU
HAVE DEVICES THAT COULD BE USED
THERE.
I SUGGEST YOU BRING THINGS
PEOPLE WANT TO USE.
SO FIRST FIND OUT WHETHER IT'S
SOMETHING THEY WOULD BE
INTERESTED IN AND IF INTERESTED
THEN YOU CAN GIVE ACCESS THROUGH
FIRST CLINICAL TRIALS.
THEY FIRST IT.
AND WHEN I FIRST GOT THERE THERE
WAS A PHONE IT A NOKIA PHONE
THAT ALSO HAD A TORCH ON THE END
SO YOU COULD USE IT AS A
FLASHLIGHT BUT THE TORCH PHONE
CHANGED PEOPLE ABILITY TO HAVE
SMALL ENTREPRENEURIAL BUSINESSES
BECAUSE YOU COULD BE IN THE
MIDDLE OF NOWHERE AND COULD GET
A SIGNAL AND NEVER BE A LANDLINE
BUT YOU COULD USE YOUR PHONE AND
THE OPPORTUNITY TO BE DISRUPTIVE
WITH THE GREAT TECHNOLOGY WE'RE
SEEING AT THE MEETING IS HIGH IN
PLACES LIKE AFRICA.
AND YOU SHOULD BE COST SENSITIVE
AND ECO FRIENDLY.
THE AFRICAN CONTINENT IS NOT THE
REASON WE HAVE GLOBAL WARMING
NOW YET THEY'LL BEAR THE BRUNT
OF THAT AND THINKING HOW NOT TO
PUT MORE PLASTIC IN THE WORLD
AND THEY CAN'T AFFORD TO SPEND
$20 ON A DIAGNOSTIC WHEN THAT
MAY BE THE PER CAPITA
EXPENDITURE FOR HEALTH AND WE
HAVE TO LOOK AT SOMETHING
AFFORDABLE.
I WILL SAY THOUGH IT CAN BE MORE
EXPENSIVE IF IT'S DISRUPTIVE.
THERE'S TRADE-OFFS WORTH
THINKING ABOUT AND I'LL GIVE
TIME FOR QUESTIONS AND TO
ENCOURAGE YOU TO MEET AS MANY AS
PEOPLE AS I GOT TO AND MEET
PEOPLE AND DON'T BE A SUITCASE
NGO AND PUT ROOTS IN THE GROUND
AND WHEN I DO SO I ALWAYS TELL
THE FOGARTY STUDENTS IT'S A
CRACK COCAINE OF WORKING ABROAD
YOU CAN DO SOMETHING NICE EVERY
DAY FOR SOMEBODY.
>> NEXT IS REBECCA
RICHARDS-KORTUM.
>> AND LOW RESOURCE SETTINGS ARE
NOT MONOLITHIC.
THEY CAN VARY TREMENDOUSLY FROM
THE HEALTH CENTER ON THE LEFT
FROM THE DISTRICT HOSPITAL ON
THE UPPER RIGHT.
ONE COMMON THREAD IS SUPPLY
CHAINS ARE FRAGILE AND PEOPLE
WILL REUSE ANYTHING THEY CAN.
YOUR GOAL IS TO KEEP THINGS OUT
OF THE EQUIPMENT GRAVEYARD WHICH
IS WHAT HAPPENS WHEN TOOLS ARE
NOT AVAILABLE OR CONSUMABLES
WERE NOT AVAILABLE.
I THINK IN TERMS OF THINKING
ABOUT DESIGN THINKING, FROM
ANOTHER PROJECT I REALLY ARE
SEEN THE POWER OF BRINGING THE
COMMUNITY TOGETHER TO THINK
ABOUT TARGET PRODUCT PROFILES
AND USE CASES AND TO ALIGN
STAKEHOLDERS INCLUDING
CLINICIANS, PUBLIC HEALTH
EXPERTS, MANUFACTURERS AND
DEVELOPERS AND NORMATIVE GLOBAL
AGENCIES TO AGREE WHAT DO WE
MEAN BY AFFORDABLE EFFECTIVE AND
RUGGED AND WHEN THERE IS
AGREEMENT ACROSS A DISCIPLINE
THAT IS A VERY VERY STRONG
SIGNAL TO MANUFACTURERS AND
TECHNOLOGY DEVELOPERS.
AND WHEN WE USE THESE START UP
PRODUCT PROFILES TO QUALIFY WHAT
WAS ON THE MARKET LOOKING AT AN
AT AN EIGHT-STEP PROCESS TO
IDENTIFY WHAT TECHNOLOGIES THAT
WERE COMMERCIALLY AVAILABLE
ACTUALLY MET THE TARGET PRODUCT
PROFILES WE LOOKED AT OVER 500
TECHNOLOGIES.
THE BIGGEST PLACE THINGS FAILED
WERE THEY WERE TOO EXPENSIVE OR
NOT USABLE.
AND WHEN THEY FAILED IN
USABILITY THEY RESULTED IN
ERRORS THAT COULD HARM PATIENTS
OR ERRORS THAT COULD DISABLE
DEVICES AND THESE ARE DEVICES
THAT HAVE REGULATORY APPROVAL
FROM ONE OF THE BIG FIVE
REGULATORY AGENCIES SO USABILITY
FROM THE BEGINNING IS A KEY
ISSUE.
FINALLY I WANT TO TALK ABOUT THE
IMPORTANCE OF BI-DIRECTIONAL
COLLABORATION.
ROB TALKED ABOUT THE GROWTH IN
THE AFRICAN CONTINENT IN THE
NEXT 20 YEARS.
IF WE LOOK AT THE FRACTION OF
COLLEGE AGE STUDENTS THAT LIVE
IN INFRASTRUCTURE, IN AFRICA ONE
THIRD OF COLLEGE AGE STUDENT IN
THE WORLD WILL LIVE IN AFRICA.
IF THOSE INDIVIDUALS ARE
EXCLUDED FROM GLOBAL INNOVATION
WE ARE MISSING A REALLY
IMPORTANT OPPORTUNITY.
SO WE'VE LOOKED AT C TAN AS A
GREAT EXAMPLE OF HOW YOU
STRENGTHEN BIOMEDICAL
ENGINEERING AND WORK FROM THE
BEGINNING BIOMEDICAL ENGINEERS
IN AFRICA AND WORKED WITH 16
UNIVERSITIES TO STRENGTHEN
INVENTION, EDUCATION WITHIN THE
AFRICAN CONTINENT.
THIS HAD A BIG PAYOFF DURING
COVID WHEN THERE WERE SUPPLY
CHAIN SHORTAGES AND THE DESIGN
STUDIOS WERE ABLE TO STEP UP AND
PRODUCE THINGS NO LONGER
AVAILABLE ON THE GLOBAL MARKET.
THAT GOT A LOT OF VISIBILITY FOR
UNIVERSITIES FROM PRESIDENTS,
FROM MINISTERS OF EDUCATION,
FROM MINISTERS OF HEALTH AND
THAT CREATED MORE SUPPORT, MORE
FINANCIAL SUPPORT INTERNALLY FOR
THE UNIVERSITIES.
AND IT'S LED TO A LOT OF NEW
PRODUCTS.
SULE SEE ONE AT THE DEMO LATER
THIS AFTERNOON CO-DEVELOPED BY
ENGINEERING AT RHYS AND NOW A
SMALL BUSINESS OPPORTUNITY IN
MALAWI.
LET ME STOP THERE TO HAVE TIME
FOR QUESTIONS.
THANKS.
>> PONG YOU HEARD FROM THE
EXPERIENCED EXPERTS HERE.
MAYBE I'LL START WITH YUKA, WHAT
ARE THE UNIQUE CHALLENGES THAT
TECHNOLOGY DEVELOPERS REALLY
FACE WORKING IN LOW-INCOME
SETTINGS, AFRICA IN YOUR CASE?
>> I THINK I TALKED ABOUT IT A
LITTLE BIT BUT IT'S THE GAPS.
IDENTIFYING THE GAPS AND SAME
FOR RESEARCH CAPACITY I WAS
CHARGED TO BUILD WHEN THERE.
IT'S GREAT TO SEE YOU AND
REBECCA ARE WORKING HARD AND
TRYING TO FIND THE GAPS AND FILL
THEM TO HAVE VIABLE PROGRAMS
WHERE PEOPLE ARE BUILDING THINGS
THEY WANT TO USE IN THEIR
SETTING AND THEIR CONTEXT
PERHAPS LOCALLY AND REGIONALLY.
I AGREE WITH THE SUPPLY CHAIN
ISSUE.
THIS WAS FIGURED OUT BY THE
CLINTON FOUNDATION EARLY ON IF
THEY WERE GOING TO OFFER
DIAGNOSTICS THEY WOULD OFFER A
BUNDLED PALATE TO MAKE SURE IF
YOU HAD IT IT WOULD GET USED AND
ONE I'D LIKE TO HIGHLIGHT IS ONE
REBECCA BROUGHT UP IS THERE'S
NOT ENOUGH PEOPLE ON THE CONTENT
WITH THE TOOLS TO FIX THINGS.
WE FUNDED ONE PERSON TO GO TO
THE U.S. TO LEARN HOW TO FIX
USUAL LABORATORY EQUIPMENT SO
YOU WOULDN'T HAVE GRAVEYARD OF
THINGS THAT WOULD TAKE UP SPACE
AND ALSO NOT WORK.
SO FROM MY PERSPECTIVE HAVING
WAYS TO QUICKLY SWAP OUT
INSTRUMENTS IF THEY'RE NOT
WORKING AND HAVING THAT KIND OF
NETWORK SO PEOPLE CAN USE AS
MANY AS OF THE INSTRUMENTS
YOU'VE DEVELOPED AS POSSIBLE.
I THINK IT'S A REASONABLE START.
>> I THINK WE'VE ALL SEEN -- HAD
HAD THAT EXPERIENCE.
REBECCA DO YOU WANT TO COMMENT?
>> I AGREE PEOPLE NEED TOOLS TO
BUILD THEIR JOB AND BUILDING THE
CAPACITY FOR BIOMEDICAL
ENGINEERING TECHNICIAN CRITICAL.
THE OTHER CHALLENGE I WOULD ADD
IS THE COST ARE SO MUCH.
IF YOU'RE WORK IN A COUNTRY
BEFORE THE PER CAPITA HEALTH
EXPENDITURES ARE LESS THAN $100
AND 75% IS FUNDED BY FOREIGN
DONATION, THOSE ARE REALLY
EXTREME COST PRESSURES.
>> HOW ABOUT A QUESTION FOR
DAVID?
BRUCE, YOU CAN ASK A QUESTION
WHENEVER YOU WANT.
>> YOU'RE DOING AN AMAZING JOB.
ONCE I START PANDORA'S BOX.
FIRST, THANK YOU SO MUCH FOR
TAKING THE PANEL ON AND THANKS
TO THE PANELISTS.
IT'S SO IMPORTANT.
WE CAN SEE THE INTERSECTIONALITY
AND KIND OF THE INTERESTING
STORY LINES THAT PARALLEL EACH
OTHER IN GLOBAL HEALTH AND
DISPARITIES THAT WE HAVE IN THE
U.S.
SO HOPEFULLY THERE'S GOING TO BE
SOME CONVERGENCE OF PURPOSE AND
MARKET AND WE CAN DO EVEN BETTER
THAN WE HAVE BEEN DOING.
ON THAT TOPIC, WHEN WE LAUNCHED
RADX WE HAD A HIGH LEVEL OF
CONFIDENCE IT COULD BE
SUCCESSFUL.
IF YOU REMEMBER THE PLOT OF
BIOMEDICAL GROWTH AROUND THE
COUNTRY.
IF WE HAD DONE THIS 10 YEARS AGO
I DON'T THINK IT WOULD HAVE
CAUGHT FIRE.
IT'S A COMMUNITY-BASED SCIENCE
PROJECT AND YOU REMEMBER WE HAD
VOLUNTEERS FROM ALL OVER THE
COUNTRY JUST HUNDREDS WHO WANTED
TO PARTICIPATE AND BE ENGAGED IN
A GLOBAL EFFORT.
SO THINKING ABOUT THAT AND
REBECCA POINTED OUT A THIRD OF
THE COLLEGE STUDENTS I THINK
IT'S MORE PERHAPS.
JUST THE ENORMOUS VITALITY IN
THE YOUTH AND PEOPLE AS WELL AS
THE UNIVERSITIES EVERYTHING IS
NEW AND YOUNG.
SO THINKING ABOUT REBECCA'S
THIRTY POINT GOING BACK AND
FORTH AND DRIVING THE DRIVE FOR
INNOVATION AND CREATING CAPACITY
BUILDING WITHIN AFRICA FROM
THOSE YOUNG PEOPLE HOW CAN WE
TAP INTO THAT AMAZING ENERGY.
WHAT CAN WE CREATE AND WHAT
STRUCTURES CAN BE ENDURING TO
AMPLIFY OUR EFFORTS AND DRIVE
THE TRANSFORMATION YOU'RE
LOOKING FOR?
>> THE PURPOSE OF THE WHOLE
PANEL.
PERHAPS A BETTER WAY TO THINK
ABOUT IT IS CAPACITY
CO-DEVELOPMENT OR SOMETHING LIKE
THAT IN THE SENSE THAT CAPTURING
THAT KIND OF ENERGY EXPOSING A
GREAT ENTREPRENEURIAL SPIRIT IN
A LOT OF PLACES THAT WE'VE
IDENTIFIED AS LOW RESOURCE
SETTING BUT NOT NECESSARILY A
GREAT ENTREPRENEURIAL ECO SYSTEM
ALL THE TIME.
AND I THINK WHEREAS THAT'S WHAT
WE HAVE IN AMERICA IS A GREAT
ENTREPRENEURIAL SYSTEM.
TAKING SOME OF THE LEARNINGS WE
HAVE HERE IN TERMS OF ENABLING
THAT AND TAKING ADVANTAGE OF
THAT SPIRIT IS ONE THING THAT
TRANSLATES WELL AND OUR
TECHNOLOGY KNOWLEDGE AND TAKING
ADVANTAGE OF THE ENERGY AND
GROWTH THAT OCCURS.
>> ALL RIGHT.
AND TO GET TO YOUR QUESTION, THE
WHOLE APPROACH TO THE
PARTNERSHIPS, THE SHARED
LEADERSHIP, THE INVOLVEMENT FROM
DESIGN TO IMPLEMENTATION AND
PUBLIC HEALTH EFFORTS.
WHEN DO YOU TRANSITION THE
LEADERSHIP TO YOUR PARTNER?
AND FOLE -- FOGARTY THE THIRD
CYCLE.
THE THIRD CYCLE FIVE YEARS AND
SECOND CYCLE LIKE WE DO WITH THE
POCTRN NOW THE THIRD CYCLE WE
SHOULD HAVE OUR FOREIGN PARTNERS
HERE AND SHOULD BE ONE OF THE
AIMS.
ANY OTHER COMMENTS ON THAT?
YUKA, GO AHEAD.
>> SO ONE OF THE WORDS I LEARNED
IN UGANDA MEANS TWIN.
I OFTEN THINK IF YOU CAN FIND A
TWIN YOU HAVE A JUNIOR PERSON
HERE AND JUNIOR PERSON THERE
THAT CAN BECOME GOOD FRIENDS
THEY EACH SEE EACH OTHER'S
PERSPECTIVE MUCH BETTER.
I KNOW IT'S SUCCESSFUL WHEN IN
UGANDA THEY GET INVITED TO THE
HOUSE AND GET TO MEET THE
GRANDMOTHER I KNOW IT WORKED.
IT'S GREAT BECAUSE EACH BRINGS
SOMETHING DIFFERENT TO THE TABLE
AND EACH HAVE AN EQUAL STAKE IN
THE PROJECT.
THAT'S GOOD.
AND I WANT TO STRESS WHAT DAVID
SAID ABOUT ECO SYSTEM.
WE USED TO CALL IT THE CAPACITY
BUILDING PYRAMID AT THE
INFECTIOUS DISEASE INSTITUTE AND
A CONCEPT THE BASE OF THE
PYRAMID THAT'S EXPENSIVE TO
BUILD BUT STANDS BETTER THAN AEN
JENGA BLOCK AND IF THE STUDENT
WON'T SUCCEED AT THE INSTITUTE
THEY PROBABLY WON'T SUCCEED
BECAUSE THERE'S SO MANY THINGS
IN THE ECO SYSTEM.
THERE HAS TO BE THE
INFRASTRUCTURE THERE TO HAVE ALL
THE BUILDING BLOCKS TO BE
SUCCESSFUL.
THERE ARE PLACES WHERE YOU COULD
BE ALBERT EINSTEIN AND WON'T
HAVE A GREAT OUTCOME.
MAYBE IF WE ALL INVEST IN THE
ECO SYSTEM THE BI-DIRECTIONAL
COLLABORATION THAT'S BEING
TALKED ABOUT COULD REACH ITS
FULL POTENTIAL.
>> I THINK FROM A PRACTICAL
OPERATI
OPERATIONAL POINT OF VIEW AND WE
SHARE IN A PROGRAM CALLED DATA
SCIENCE AND INNOVATION IN AFRICA
WHICH IS A FABULOUSLY SUCCESSFUL
COMMON FUND PROGRAM.
WE HAVE SO MANY
INTERSECTIONALITIES BETWEEN
POCTRN AND DSI AFRICA.
THAT'S AN EXISTING STRUCTURE AND
PETER CAN PROBABLY ELABORATE
MORE ON THE DETAILS OF THE
IMPACT AND GROWTH OF THE
STRUCTURE CAPTURING THE
CONTINENT.
I THINK THAT'S AN OPPORTUNITY
FOR TARGETING THAT KIND OF
GROWTH WHERE COULD WE SEE THE
BIO ENGINEERING CURVE GROW LIKE
WE SAW IN THE U.S.?
IS THAT POSSIBLE AND COULD WE
PARTNER WITH YOU TO DO THAT?
>> I THINK IT'S TOTALLY
POSSIBLE.
I THINK GOING BACK TO YUKA'S
POINT, WE JUST HAVE TO FILL IN
THE GAPS.
THEY'LL HAVE MORE GAP THAN WE
HAVE HERE BUT WE COULD FOCUS ON
THOSE GAPS AND WORK IT FROM
THERAP -- THERE.
LET ME ASK ANOTHER COUPLE
QUESTIONS AND THEN TURN IT OVER
TO THE AUDIENCE.
WE STILL HAVE SOME TIME HERE.
ONE QUESTION I WANT TO GET TO
EARLIER THAN LATER IS RECIPROCAL
INNOVATION.
I THINK THIS IS ONE THING THAT
WE DON'T THINK ABOUT THAT MUCH
BUT IT'S THERE AND REAL.
I'D LIKE THE PANELISTS TO
COMMENT ON AN EXAMPLE PERHAPS
THEY SEE SOMETHING THAT WE
DEVELOPED OVER THERE MAYBE
COMING BACK OVER HERE.
>> I DON'T KNOW THAT WE DON'T
THINK ABOUT RECIPROCAL
INNOVATION VERY MUCH.
I THINK THE INNOVATIONS MADE
MANY ARE TRANSLATABLE TO BE AN
ALTERNATIVE.
>> AN EXAMPLE THAT SURPRISED ME
FROM OUR PROGRAM AND IMPACT WAS
WORKING WITH OUR COLLEAGUES
DOING A LOT OF TRAINING OF
HEALTH CARE PROFESSIONALS DOING
DIAGNOSIS AND ASKED FOR HANDS-ON
TOOLS TO BE ABLE TO GIVE PEOPLE
HANDS ON EXPERIENCE AND HAD A
TEAM OF ENGINEERING FROM MALAWI
AND THINKING ABOUT EXAMPLES LIKE
THAT WHERE YOU'RE MAKING A
TRAINING TOOL, IT DOESN'T HAVE
GO THROUGH THE SAME APPROVAL
PROCESS OR MANUFACTURED IN A
FACILITY THAT MEETS CERTAIN
STANDARDS BECAUSE IT'S FOR
TRAINING HEALTH CARE
PRACTITIONERS AND A GREAT WAY TO
ENABLE LOCAL ENTREPRENEURS TO
GET A PRODUCT OUT AND BREAK IN
SMALL AMOUNTS OF REVENUE.
>> MAYBE WE'LL OPEN UP TO THE
AUDIENCE HERE.
A QUESTION HERE.
>> YES AND I'M PETER KIL MARX
FROM THE FOGARTY CENTER AND WE
WERE AN AFRICA CALL AND LET ME
KNOW ABOUT THE SESSION AND I GOT
OVER HERE.
THIS HAS BEEN TERRIFIC AND
YOU'RE HITTING ALL THE THEMES
AND ONE OF THE EXPLICIT GOALS TO
THE DATA SCIENCE INNOVATION IN
AFRICA COMMON FUND PROGRAM IS TO
HAVE THE ENGAGE THE AND
CO-INVESTMENT FROM THE
GOVERNMENTS IB AFRICA AND FROM
THE PRIVATE SECTOR AND WHAT
YOU'RE SEEING IN TERMS OF THE
ENGAGEMENT AND SUPPORT.
AS THE AFRICA PROGRAM IS NOT
NECESSARILY THEY'RE CO-FUNDING
AT SOME LEVEL BUT THE REGULATORY
ENVIRONMENT OR PROVIDING A
PLATFORM ON THEIR PHONES FOR AN
INNOVATION AND WHAT ARE YOU
SEEING IN TERMS OF THE
GOVERNMENT AND PRIVATE SECTOR
ENGAGEMENT?
>> I THINK THE ENGAGEMENT WITH
THE KEY STAKEHOLDERS INCLUDING
THE APPROPRIATE GOVERNMENT
OFFICIALS IS ESSENTIAL OR YOUR
PROJECT IS NOT GOING TO WORK.
THERE'S GOING TO BE A LOT OF
MONEY WASTED.
I'M SURE WE'VE ALL SEEN NGOs
THAT HAVE GONE IN.
WELL MEANING PEOPLE WITH A LOT
OF MONEY GO IN AT THE END OF THE
DAY.
WHAT MAJOR THING HAS HAPPENED.
NOTHING.
IN A LOT OF CASES IT'S WASTED
MONEY DOWN THE DRAIN.
I DON'T KNOW IF ANYONE ELSE
FEELS AS STRONGLY AS I DO BUT
WE'RE ALL PRETTY MUCH INTEGRATED
WITH THE PEOPLE IN THE COUNTRY.
IF THEY DON'T WANT IT, IT'S NOT
GOING TO HAPPEN.
>> I THINK IT'S INTERESTING.
I DO THINK THAT THERE ARE
TRUSTED INSTITUTIONS WHERE
THEY'RE VERY INDIGENOUS AND
TRUSTING OF THEIR GOVERNMENTS
AND TO THE MINISTRIES OF HEALTH
AND MANY OF THOSE PLACES HAVE A
HUGE FOGARTY FOOTPRINT, PETER.
I THINK IT'S GREAT TO SEE THE
SEEDS BEARING FRUIT WHERE YOU
HAVE A CRITICAL MASS OF PEOPLE
WILLING TO DO THAT.
I DON'T KNOW THAT COULD BE
DRIVEN FROM OUR SIDE.
I THINK IT TO BE DRIVEN FROM
WITHIN FROM PEOPLE WHO
UNDERSTAND THE PROBLEMS AND
THINK ABOUT THE SOLUTIONS AND I
ALSO WANTED TO MAYBE PROCESS
INNOVATION IS AS IMPORTANT AS
TECHNOLOGIC INNOVATION AND THINK
OF HIV AND TUBERCULOSIS WHERE
COUNTRIES HAVE DONE A GREAT JOB
BY MANAGING THE PROCESS
DIFFERENTLY AND HAVING METRICS
AND TUBERCULOSIS THE REGISTER OF
PRESUMPTIVE TB AND KNOWN TB OR A
PERSON TO GET TREATED WEREN'T
LINKED BUT AS SOON AS THE MET
WICK WAS PUT IN PLACE IN UGANDA
TO MAKE SURE EVERYTHING THAT GOT
DIAGNOSED WITH TB WAS IN THE
CLINICAL REGISTER WHERE 25% OF
THE PEOPLE WOULD BE MISSING THAT
CHANGED.
THAT COUNTRY HAS IMPROVED CASE
FINDINGS SIGNIFICANTLY.
THAT'S ALL PROCESS INNOVATION.
THAT IS NOT ANYTHING YOU NEED TO
PAY FOR AND NEVER GOING TO SIT
ANYWHERE AND ROT.
IT'S EDUCATING PEOPLE TO DO
THINGS DIFFERENTLY.
MAYBE ALWAYS BE CREATIVE IN THE
WAY YOU APPROACH THINGS.
>> QUESTION HERE.
>> I'M WITH A START-UP COMPANY
FOR A.I. AND WE HAVE NOT DONE
ANYTHING MEDICAL BUT WE HAVE
DONE IN OTHER AREAS.
AND DR. MANABE SAID THE NEW
TECHNOLOGY USUALLY BRINGS MORE
EXPENSES TO GET INTRODUCED TO
SOCIETY AND USUALLY TRUE BUT
DOESN'T HAVE TO BE.
THERE'S HUNDREDS OF THOUSANDS OF
SERVERS AND SOME ARE USING ONLY
$20 PER MONTH AND PER YEAR THEY
HAVE MILLIONS IN LOSS AND THEY
SAID A SINGLE CROWD SERVER FOR
ONE OF THE BIG COMPANIES WILL
SPEND MORE ENERGY THAN COUNTRIES
LIKE ARGENTINA AND IRELAND AND
90% OF THE COUNTRIES IN THE
WORLD.
THE A.I. WHICH WANTS TO HELP THE
MEDICAL FIELD WILL BE MORE
DESTRUCTIVE FOR HUMANITY.
THAT MEANS YOU WANT TO CURE
CANCER AND SAY TO THE PATIENT
I'M GOING TO SHOOT YOU WITH THE
BULLET AND THEN ZAP YOUR TUMOR
BY BULLET.
THE CURE IS GOING TO BE WORSE
THAN THE INITIAL DISEASE.
IN THIS CASE IF WE CONTINUE FOR
THE FUTURE TO USE THE A.I. TO
HELP SOCIETY AND MEDICAL FEED AS
A SUBSET IS GOING TO BE THE CURE
WILL BE WORSE THAN THE DISEASE
ITSELF.
SO A.I. WOULD BECOME DESTRUCTIVE
BECAUSE THIS CARBON FOOTPRINT
AND EACH CENTER MIGHT BE BIGGER
THAN A SINGLE COUNTRY IN ENERGY
AND WATTAGE USAGE AND THE SAME
PROPORTION YOU'RE PRODUCING THE
CARBON FOOTPRINT ELEMENT TWICE
BECAUSE YOU HAVE TO RUN THE GPU
AND COOL DOWN THE SYSTEM AND YOU
HAVE TO COOL DOWN THE SYSTEM.
IT'S GOING TO BE MULTIPLE TO RUN
THE GPUs.
IT'S GOING TO BE HUGE.
BASICALLY --
>> YOU HAVE TO WRAP IT UP.
WE'RE RUNNING OUT OF TIME.
>> IT'S NOT SUSTAINABLE.
IT DOESN'T HAVE TO BE.
FOR OUR COMPANY WE'RE USING A
DIFFERENT METHOD CALL CONCEPT
LEARNING.
WE CAN USE SIX ORDERS OF
MAGNITUDE LESS WATTAGE TO GET A
BETTER ACCURACY THAN THE NETWORK
AND WE HAVE GUYS FROM CAL TECH
AND BERKELEY AND USING IT FOR
U.S. AIR FORCE AND IT'S BEEN
VERY SUCCESSFUL.
WE CAN TALK MORE.
THERE'S OTHER ALGORITHMS BETTER
AND MORE EFFICIENT FOR GLOBAL
RUNNING.
YOU CANNOT SAY DON'T COME TO MY
COUNTRY.
IT BELONGS TO ANOTHER COUNTRY.
IT COMES THROUGH THE ATMOSPHERE.
>> THANK YOU VERY MUCH FOR YOUR
COMMENTS.
IS THERE ONE OTHER QUESTION?
IT'S GOT TO BE QUICK?
>> FOR THE TECHNOLOGY
DEVELOPERS, WHEN THEY TRY TO
DEVELOP A TECHNOLOGY AND GO TO
THEIR INVESTORS AND SAY THE
DIRECTION GOES INTO THE UNITED
STATES BECAUSE IT'S THE BIGGEST
MARKET, GIVE ME THREE REASONS
THAT AN ENTREPRENEUR, SMALL
BUSINESS OWNER CAN SAY IN THEIR
PITCH DECK TO SAY I WANT TO GO
TO AFRICA AND DO THIS WORK WITH
AFRICA AND THEN BE ABLE TO GET
TO INNOVATE IN THEIR MARKET OR
SOMETHING IN THEIR PITCH DECK
FOR INVESTORS TO GET BEHIND YOU?
IS THAT FAIR?
DO YOU UNDERSTAND WHAT I'M
ASKING.
>> I'LL GIVE THE EASY ONE WHICH
IS GROWTH.
>> ALL RIGHT.
WE'RE A LITTLE BIT OVER TIME.
WE'RE GOING TO CONCLUDE THE
SESSION NOW.
WE'RE AVAILABLE HERE THE REST OF
THE DAY IF ANYONE HAS ANY
QUESTIONS.
PLEASE FEEL FREE TO ASK.
THANK YOU ALL FOR YOUR
PARTICIPATION.
>> ALL RIGHT.
THANK YOU.
SO WE ARE GOING -- WE DID GO
OVER A BIT OVER TIME AND
RECONVENE HERE AT 1:30.
LUNCH WILL BE UPSTAIRS IN THE
CAFETERIA.
THANK YOU.
WE'RE GOING TO GET STARTED WITH
THE PANEL FROM 1:30 TO 2:30 AND
GO INTO OUR KEY NOTE SPEAKER AND
FOLLOW-UP WITH THE FUTURE OF
POINT-OF-CARE TECHNOLOGIES AFTER
THE RAPID PITCH SESSION.
IT WILL BE A BIT OF A CHANGE BUT
WE'LL COVER EVERYTHING.
NOW I'LL INTRODUCE DR. ANDREW
WEIS LEADING THE PANEL ON
DIGITAL HEALTH.
THANK YOU.
>> THANKS EVERYONE FOR BEING
PROMPT AFTER LUNCH AND A QUICK
INTRO REMARKS AND WE HAVE A FEW
ERRORS ON THE SLIDE BUT I'LL
CORRECT THOSE AS I TALK.
WE HAVE TALKED ABOUT DIGITAL
HEALTH.
THERE'S BEEN BITS AND PIECES
THROUGHOUT.
I'M EXCITED WE HAVE A FULL
SESSION TO DEVOTE TO THIS NOW.
MYSELF BEING TRAINED AS AN
ENGINEER I LIKE TO THINK OF EACH
DIAGNOSTIC TEST RESULT AS A DETE
POINT THAT CAN BE USE TO CONNECT
PATIENT TO CARE AND MONITOR
DEVICE POST MARKET AND IT'S
DIFFICULT TO CAPTURE DIAGNOSTIC
DATA ESPECIALLY IN A TIME WHEN A
LARGE PERCENTAGE OF THE
POPULATION IS TESTING IN THE
PRIVACY OF THEIR OWN HOMES.
DIGITAL HEALTH AND APPS ALL ADD
VALUE TO DIAGNOSTIC DATA
GENERATED OUTSIDE OF TRADITIONAL
CLINICAL SETTINGS.
IN THE PANEL WE'LL HIGHLIGHT
SEVERAL OF THOSE OPPORTUNITIES
AS WELL AS CHALLENGES WITH AN
EYE TOWARDS DIGITAL HEALTH
TECHNOLOGIES CAN BE USED TO
UNLOCK THE FULL POTENTIAL OF AT
HOME TESTS.
WE HAVE TWO PANELISTS FROM
INDUSTRY.
ONE FROM GOVERNMENT NOT THE
CORNELL U.S. FDA BUT FDA AND
EACH WILL SHARE UNIQUE
EXPERIENCES AND PERSPECTIVES
ABOUT AUGMENTING AT-HOME TESTING
WITH AT-HOME MOBILE APPS AND
DIGITAL HEALTH TOOLS.
I'LL INVITE THE PANELS UP TO
GIVE A 10 TO 12 MINUTES
PRESENTATION.
WHILE THEY'RE TALKING THINK ANY
QUESTIONS YOU MAY HAVE.
WE'LL HOLD QUESTIONS UNTIL AFTER
ALL THREE GIVE THEIR
PRESENTATIONS AND I'LL HAVE
QUESTIONS FOR THEM AND WE'LL GET
YUSHZ IN AS WELL.
WE HAVE A FULL HOUR AND SHOULD
STILL HAVE A GOOD AMOUNT OF TIME
FOR PANEL DISCUSSION AND
QUESTIONS.
IT'S MY PLEASURE TO INTRODUCE --
I FORGOT ONE THING.
SPEAK OF DIGITAL HEALTH.
CAN YOU RAISE YOUR HAND IF YOU
HEARD OF MAKE MY TEST COUNT.
HOW ABOUT IF YOU REPORTED A
RELATE ON MAKE MY TEST COUNT?
MANY -- I SHOULD HAVE MY HAND UP
FOR BOTH.
YOU'LL BE HEARING ABOUT MAKE MY
TEST COUNT FROM VIK'S
PRESENTATION BUT IT'S ONE
EXAMPLE OF A DIGITAL HEALTH
TECHNOLOGY.
HOPEFULLY EVERYONE'S FEELING ALL
RIGHT, IF NOT, PLEASE TEST AND
IF YOU DO, CONSIDER REPORTING TO
MAKE MY TEST COUNT.org.
IT'S MY PLEASURE TO INTRODUCE
OUR FIRST SPEAKER, DR. VIK
KHETERPAL.
A PRINCIPAL AT CARE EVOLUTION AN
I.T. COMPANY THAT PROVIDES
INTEROPERABILITY HEALTH CARE
SOLUTION FOR PUBLIC HEALTH AND
CLINICAL TRIALS AND CONSUMER
ENGAGEMENT AND THE PLATFORM HAS
BEEN USED BY VARIOUS LARGE
PROGRAMS INCLUDING LARGE NIH
PROGRAMS AND BY RADX AND VIK IS
ACTIVE IN THE INTEROPERABILITY
AND DIGITAL HEALTH SPACE.
I'VE WORKED WITH HIM CLOSELY THE
PAST THREE YEARS AND LEARNED A
LOT FROM HIM AND IT'S MY HONOR
TO INVITE YOU UP HERE VIK AND
TAKE THE PODIUM.
THESE
>> MY PERSPECTIVE ON THIS THING
IS RELATED TO PULLING TOGETHER
THE IDEA OF LIFE TIME RECORD IF
YOU HAVE LONGITUDINAL
INFORMATION ON EACH OF US WE
COULD DO BETTER THINGS WHETHER
IT'S RESEARCH WHETHER IT'S CARE
DELIVERY, OTHER KINDS OF THINGS.
IT'S HARD TO PUT THINGS TOGETHER
WHEN THEY'RE ON PAPER.
THE FILING CABINETS GET VERY
LARGE WHETHER IT'S MEDICAL
RECORD OR LOOK AT OUR OWN LIVES.
IF YOU HAVE BILLS, MUCH EASIER
TO ORGANIZE THOSE AND
PHOTOGRAPHS AND ALBUMS IF
THEY'RE DIGITAL.
WE'VE SEEN DIGITIZATION OF
INFORMATION.
THE LAST COUPLE DAYS OR TODAY
AND YESTERDAY, A LOT OF THE
CONVERSATION AROUND POCTRN IS
INFORMATION MANAGEMENT MOVING
THINGS FROM ONE PLACE TO ANOTHER
AFTER THE GREAT INNOVATION.
MY THINKING COMING INTO THE
CONVERSATION IS MAYBE HELP
ANSWER WHAT IS DIGITAL HEALTH BY
DOING A BIT OF A SHOW AND TELL
BY GOING THROUGH PROJECTS WE'VE
BEEN INVOLVED WITH.
THE PERSPECTIVE IS OF COURSE
SPECIFICALLY GEARED TOWARDS THE
WORK WE'VE DONE WITH RADX TECH
AND NIH AND MANY INITIATIVES YOU
SEE LISTED HERE IN THE RED BOXES
ARE THINGS DIGITAL TOOLS ARE
HELPING MOVE FROM ONE PLACE TO
THE OTHER.
THERE'S DIFFERENT WAYS THIS IS
HAPPENING AND WAS ACCELERATED IN
SOME WAYS IN 2020 BECAUSE OF THE
PANDEMIC.
MANY OF THESE THINGS WERE ABOUT
LONG BEFORE THEN.
THE ABILITY TO HAVE A DIGITAL
TRIAL WAS NOT NEW AND IS NOT NEW
TODAY.
THE ABILITY TO HAVE SENSORS.
WE'VE HAD IT NOW FOR 15 YEARS
AND LONGER.
A LOT OF THESE THINGS HAVE
EXISTED BUT I THINK THE PANDEMIC
WAS THE MOTHER OF INVENTION AND
CHALLENGED OUR TYPICAL WAY WE
ORGANIZE OURSELVES, OUR
PROCESSES, OUR DECISION MAKING
APPARATUS BECAUSE WE HAD
SOMETHING WE JUST DID NOT
UNDERSTAND AND WE NEEDED TO
ACCELERATE THE PACE WITH WHICH
WE DID NOVEL DISCOVERY.
I THINK WE GAVE OURSELVES
PERMISSION TO DO THINGS IN A
DIFFERENT MANNER AND TAKE
CERTAIN KINDS OF RISK.
WE LAUNCHED THE DETECT STUDY
WITH DR. TOPOL AND SCRIPTS
SCRIPPS AND ENROLLED 3,000 TO
4,000 PEOPLE AND STARTED TO SEE
SIGNAL IN HOW I'M FEELING FROM
PARTICIPANTS IN THEIR FITBITS
AND APPLE WATCHES AND GARMIN
DEVICES AND THAT WAS REMARKABLE
AND PUBLISHED IN NATURE AND
MEDICINE SEVEN MONTHS AFTER
IDEATION.
JUST THE COMPRESSION OF TIME
LINE HERE I THINK GAVE MANY OF
US CONFIDENCE THIS WAS WORTH
SPENDING TIME AND ENERGY ON.
OF COURSE WITH THE RADX CLINICAL
CORPS WE STARTED TO WORK ON
KNOWLEDGE DISCOVERY BY LAYERING
IN A DIGITAL DECENTRALIZED
DESIGN ON EXISTING QUESTIONS
THAT WERE REALLY IMPORTANT TO
ANSWER.
THAT WE NEEDED ANSWERS ON MUCH
FASTER THAN TYPICAL.
I THINK THAT'S THE ENDURING IDEA
AROUND DIGITAL HEALTH IS HOW DO
WE LAYER THE TOOLS IN TO
ACCELERATION OF FEASIBILITY AND
SCALABILITY AND ECOLOGICAL
ASSESSMENT IN THE REAL WORLD OF
HOW THERAPY MAY BE WORK.
GOING DEEP ER ITAP WAS IN
INNOVATION AND PROCESS AND NIH
AND GOVERNMENT WORKING TOGETHER
TO UP WITH A NEW VEHICLE TO
THINK THROUGH AS HUMAN BEINGS TO
COME UP WITH SOMETHING.
WE DID DIGITAL ITAP WHICH HELPED
WITH ENROLLMENT OUT THERE AND
THAT'S A BIT OF A SUPER CHARGING
THE INNOVATION THAT COMES FROM
RETHINKING HOW WE ORGANIZE
OURSELVES TO REACH PARTICIPANTS
IN A DIGITAL FASHION.
WE WERE ABLE TO BRING PRODUCTS
TO MARKET FASTER.
THAT'S ONE ROLE OF DIGITAL
HEALTH AND WE HAVE A DIFFERENT
PROBLEM.
WE NEEDED TO DISTRIBUTE THESE
THINGS TO LITERALLY MILLIONS OF
PEOPLE.
NOT ONCE BUT POTENTIALLY USING
THESE TESTS AND THEY MAY NEED
THE TESTS REPEATEDLY AND THE
COVID TEST BECAME A VEHICLE
WHERE THE DIGITAL LAYERING
BECAME A BRIDGE TO IMPROVED
ACCESS TO THIS NEW DIAGNOSTIC
INNOVATIVE AND BROUGHT TO MARKET
IN RECORD TIME.
THE IDEA WAS TO BE ABLE TO
PROCURE IT AND AMAZON WAS DOING
ONE TO TWO DAY SHIPMENTS AT THAT
TIME.
YOU COULD ORDER RIGHT ABOUT NOW
AND MANY FOLKS WOULD HAVE IT
DELIVERED TO THEIR HOME THE NEXT
DAY.
THOSE KINDS OF THINGS WERE
INTERESTING BECAUSE WE WERE ABLE
TO LAYER A DIGITAL TOOL IN THERE
BECAUSE NOW I'VE TAKEN THE TEST
AND THE INSTRUCTION HOW TO TAKE
THE TEST WITH THE DIGITAL TOOL.
THE ABILITY IN BEING ABLE TO
PERFORM THIS TEST WAS IMPROVED
AND THEN I CAN REPORT THAT TEST.
THAT'S THE EARLIEST PARTS AND
THE INTERFACE THAT CAME OUT.
WE WANTED TO MOVE THIS TO THE
APHO SO IT LOOKS LIKE ANY OTHER
TEST THAT DIABETES REPORTED ON
THE PART OF THE CONSUMER AND HAS
COME TO MAKE MY TEST COUNT
TODAY.
THE NEXT THING THAT STARTS TO
HAPPEN IS I'VE DONE THE
DIAGNOSTIC TEST.
I'VE BEEN ABLE TO UNDERSTAND
SOMETHING ABOUT MYSELF WHICH IS
REALLY NOVEL BECAUSE WHEN
CORPORATIONS READ THE TEST IT'S
NOVEL AND USUALLY THE DOCTOR
READS IT AND THE NURSE READS IT
AND THE PATIENT KNOWS IT AND WE
NEED THE CONSUMER TO TAKE ACTION
FOR THE TEST TO HAVE VALUE.
WHAT'S VERY INTERESTING HERE
WHEN YOU DO THINGS POINT OF CARE
BRINGING UP THE QUESTION OF
WHERE IS THE POINT OF CARE?
THAT'S THE AHA AND THE TOOL
ALLOWED US TO DO DIGITAL
PROGRAMS IN SCHOOLS SO IF YOU
WERE SOMEBODY A KID WHOSE
SITTING IN CLASS AND THERE IS
SOMEONE NEAR THEM INSTEAD OF
SAYING YOU NEED TO STAY HOME FOR
FIVE TO SEVEN DAYS, WE WORK WITH
U MASS AS WELL AS NIBIT FUNDED
THIS WORK AND CHANGING THE
REGULATION TO SAY IF YOU DO
DAILY TESTING AND REPORT YOUR
RESULTS YOU DON'T HAVE TO STAY
HOME.
YOU CAN COME TO SCHOOL AS LONG
AS YOU DO DAILY TESTING AND
REPORT YOUR RESULTS THE DAY
BEFORE.
NOW WE'RE MOVING FROM
INNOVATION, DISCOVERY,
DISTRIBUTION, LOGISTICS, AND NOW
ACTUALLY REPORTING AND WHAT'S
HAPPENING WITH DIAGNOSTIC
RESULTS TO IMPACTING BEHAVIOR
AND HAVING IMPACT IN ONE FELL
SWOOP.
IT GETS MORE INTERESTING.
WE'VE HEARD OF TEST TO TREAT.
IT'S ANOTHER INITIATIVE WE'VE
PARTICIPATED IN WITH VARIOUS
HEALTH DEPARTMENTS TO TAKE THIS
INDIVIDUAL AND THEIR OWN
BEHAVIOR IS CHANGING AND IN
ADDITION WE CAN CONNECT THEM TO
THERAPIES AND THEY CANNOT ONLY
GET ACCESS TO THERAPY IN A
DIGITAL FASHION, MAYBE IT GETS
DELIVERED TO THEIR HOME AND THEY
CAN REPORT THEIR RESULTS HOW
THEY RESPONDED TO THE THERAPY
CLOSING THE INFORMATION LOOP
AGAIN.
ALL OF THIS IMPORTANT WITH THE
LAB CORPS AND THE QUEST LABS AND
WHERE WE WANT TO GET TO IS THE
PATIENT'S HOME BECAUSE THAT'S
WHERE WE ALL LIVE.
THE POINT OF CARE ALMOST SEEMS
LIKE A MISNOMER.
IT'S WHENEVER THE PATIENTS
HAPPEN TO BE AT AND MAY BE AN
INTERESTING SUPER POWER.
WHAT WE'RE TRYING TO DO WITH
THESE KINDS OF TECHNOLOGIES IS
THEY'RE JUST A FEEDER AND
SENSORY FEEDER AND THE PURPOSE
IS TO CAUSE BEHAVIOR CHANGE OR
THERAPEUTIC CHANGE AND THERE'S A
REAL SUPER POWER LATENT IN THERE
WITH ONE FELL SWOOP BECAUSE THE
PATIENT TRYING TO IMPACT WITH
THERAPY IS THE ONE WHO
UNDERSTANDS WHAT THE TEST DOES
AND THAT'S AN INTERESTING
DYNAMIC AND PRETTY EXCITING.
IN 2015 WE STARTED THINKING
ABOUT THE STUFF WITH THE
FRAMINGHAM HEART STUDY SAYING IF
PEOPLE ARE GOING TO DO THESE AT
HOME WHAT IS THE DEFINITION OF
HYPERTENSION?
WHAT DO I DO WITH PEOPLE TAKING
BLOOD PRESSURES AT HOME?
WHICH IS RIGHT?
WE DO RESEARCH AND THE DATA IS
BASED ON THE ONE WE'RE
ACCUSTOMED TO BUT MAYBE WHITE
COAT HYPERTENSION AND MAYBE
THERE'S A BETTER MARKER FOR WHAT
IS HYPERTENSION AND I DON'T KNOW
HOW ONE TAKES CARE OF A DIABETIC
TODAY WITHOUT UNDERSTANDING THE
REPUBLICANS OF THE CGM DATA.
THIS IS INTERESTING AND A
FOUNDATIONAL CHANGE AND IT'S
HARD BECAUSE WE HAVE TO MAKE
CHANGES TO HOW WE'RE STRUCTURED
AND DEFINING GOLD STANDARDS AND
THAT'S WHERE THE WORK WE NOW DO
IS CENTERED.
ONE COOL THING THAT STARTS TO
HAPPEN IS PATIENTS HAVE 50% OF
MEDICATIONS PRESCRIBED MAYBE UP
TO 70% TO TAKING THEM SOME DON'T
FILL THEM OR FILL THEM BUT DON'T
TAKE THEM OR SOMETIMES AND THE
CONSUMER IS ENGAGING IN THEIR
CARE AND FITNESS.
THE IDEAS AROUND RETURN OF
INFORMATION AND RETURN OF VALUE
CAN BE EMBEDDED IN THE ACTUAL
EXPERIENCE FROM THE GET GO.
WE ALSO CAN DO INTERESTING
THINGS ABOUT REAL WORLD DATA.
THE AS LIVED EXPERIENCE OF
CONSUMERS AT HOME.
HOW DO YOU CAPTURE INFORMATION
ABOUT A POPULATION ACROSS THE
NATION IF WE RECRUIT THEM FROM A
HEALTH SYSTEM.
WE USUALLY GET THE E.H.R. REAL
WORLD DATA FROM THAT HEALTH
SYSTEM BUT ON A LONGITUDINAL
BASIS WE TEND TO MOVE AROUND AND
GO TO MULTIPLE PROVIDERS NOT
JUST A PLACE I MAY HAVE BEEN
RECRUITED INTO A TRIAL.
HOW DO I GET LONGITUDINAL DATA
OVER FIVE OR 10 YEARS?
ABOUT 250,000 FOLKS AND WE SEE
ABOUT 80% ARE USING SOME SORT OF
A SMART PHONE AND THESE ARE THE
SAME PEOPLE WE CAN DO
INTERESTING INFORMATION TO THEM
AND THE NEW REGULATIONS ALLOW
CONSUMERS TO ACCESS THEIR EMR
AND HAEBLG CLAIMS -- HEALTH
CLAIMS IN AN APP OF THEIR CHOICE
AND WE THOUGHT HOW ABOUT WE HAVE
THE CONSUMERS THAT WITH THE
RESEARCHER.
AND WHILE DOING IT WE CAN DO
RETURN OF VALUE BECAUSE WE SHOW
THEM WHAT WE GOT FROM THE E.H.R.
THEY HAVE A HEALTH AND WELLNESS
DASHBOARD AND CONNECTING INTO
ONE DEDUPLICATED LIST FOR THEIR
OWN SELF-USE AND SELF-AGENCY.
PEOPLE ARE USING IS IT.
THERE'S 60,000 PEOPLE AND WE
HAVE SOME PEOPLE WITH UP TO 21
DIFFERENT ONE PERSON CONNECTED
TO 21 DIFFERENT PROVIDERS IN THE
LAST COUPLE YEARS.
LOTS OF PEOPLE CONNECTED TO TWO,
THREE, FOUR, FIVE PROVIDERS AND
NOW STARTING TO GET LONGITUDINAL
DATA VIA THE CONSUMER.
WE CAN NOW ACCESS IN THE
PARTICULAR TRIAL DATA COMING
FROM 1600 DISTINCT PROVIDERS AND
HEALTH SYSTEM AND TO GET THAT
REAL WORLD DATA ONLY THE OLD
FASHION WAY SENDING IT THE
SYSTEM AND SEND TO ERS IS
UNTENABLE TO PUT TOGETHER AND
THIS IS POINT OF CARE BECAUSE
THEY'RE USING A WIDGET AND USING
THE SMART PHONE AND GET RETURN
OF VALUE.
IT CREATES STICKINESS AND EN
ENGAGEMENT WHICH GETS
INTERESTING WITH MULTIOMIC DATA
AND THINGS WE'RE TRYING TO DO TO
MOVE THE NEEDLE IN THIS KIND OF
WORK TO HAVE GLYCOSYLATED
HEMOGLOBIN.
AND CONTINUOUS GLUCOSE MONITOR
AND SYSTEM INFORMATION AND
SYMPTOMOO LOGY AND WE HAVE
VALIDATED INSTRUMENTS.
THEY HAVE GREAT VALUE AND WILL
ALWAYS CONTINUE TO HAVE GREAT
VALUE BUT WE'RE NOW BEGINNING TO
LAY INTO THAT IN MY OWN WORDS
HOW I'M FEELING TODAY.
THIS BECAME IMPORTANT WITH
THINGS LIKE LONG COVID.
WE HAVE TO BE PERMISSIVE OF
ENABLING THE CONSUMER TO
DESCRIBE IN THEIR OWN WORDS WHAT
THEY'RE FEELING.
SO TOOLS THAT ARE INVERTED WERE
IN THEIR OWN WORDS DESCRIBING
WHAT'S GOING ON AND GET THE
REASON THEY DO IT IS NOT TO
SHARE IT WITH THE RESEARCHER OR
CAREGIVER.
THEY DO IT BECAUSE THEY WANT TO
MAINTAIN A DIARY FOR THEMSELVES
AND MAKE A PDF OF THE DIARY AND
WHEN THEY GO TO THE CLINICIAN
THEY'RE ABLE TO SHARE A SUMMARY.
WHAT HELPS THEM BE A BETTER
PARTICIPANT IN NOTICING TRENDS
IN THEIR OWN HEALTH AND THESE
EXPERIENCE POWERFUL.
WE'RE FINDING PATIENTS AND
CONSUMERS WE DON'T CALL THEM
PARTICIPANTS BECAUSE THEY'RE NOT
NECESSARILY IN HUMAN SUBJECTS
RESEARCH IN EVERY CASE.
IT BECOMES A GRAY LINE OFTEN
TIMES THE FOCUS JUST WANT TO USE
THE TOOLS FOR SELF EFFICACY.
THAT'S WHAT WE -- WHEN I SAY A
SUPER POWER, THAT'S EXCITING.
OTHER COOL STUFF GOING ON
THERE'S COOL INTERESTING
DIAGNOSTICS LIKE THIS -- I'M
ALMOST DONE, THIS KIT BEING
USED.
WE'VE BEEN TRACKING A KIT WITH
THE QRI THE WAY IT COMES AND DO
THIS TO YOURSELF, WHAT IS THE
RATE AT WHICH WE GET SUPPORT
HEALTH CALLS TO SAY I COULD OR
COULDN'T SUCCESSFULLY PERFORM
THAT TASK.
VERSUS THE COHORT WITH A DIGITAL
TOOL THAT WALKS THEM THROUGH ONE
TO DO NEXT AND THERE'S A MARKET
DIFFERENCE.
PEOPLE HAVE AN EASIER TIME.
IT'S NOT NECESSARY AND REQUIRED
BUT PROMISING.
AND IT ENGENDERS TRUST WHICH IS
REALLY IMPORTANT AS WE THINK
ABOUT INEQUITIES AND THE KIND OF
CONCERNS I THINK WE ALL SHARE
WHICH IS HOW DO WE MAINTAIN
TRUST WITH PATIENTS AND ENHANCE
TRUST WITH POPULATIONS THAT MAY
HAVE NOT HAVE A GREAT
RELATIONSHIP WITH THEIR
TRADITIONAL HEALTH CARE PROVIDER
OR RESEARCHER.
I'M GOING TO SKIP THROUGH A
BUNCH OF THESE THINGS TO GET TO
THIS QUESTION OF GREAT WORK.
WE DELIVERED ABOUT 100 MILLION
TESTS TO 5 MILLION HOUSEHOLDS IN
19 STATES.
THE QUESTION IS WILL THAT
EXACERBATE INEQUITIES?
WILL THIS BE AFFLUENT PEOPLE,
HIGHLY EDUCATED THAT USE THE
DIGITAL ORDERING PROCESS.
IT TURNS OUT THAT IS NOT WHAT
HAPPENED.
THERE IS NO DIRECT CORRELATION
BETWEEN WHAT WE TRACKED WITH THE
SOCIAL VULNERABILITY INDEX TO
THE DIGITAL ORDERING AS A
MECHANISM OF ACCESSING THE TEST
AND WHAT WE HEARD IN FOCUS
GROUPS IS I CAN'T TAKE TIME OFF
BECAUSE I'M AN HOURLY WORKER.
I DON'T HAVE TRANSPORTATION.
I LIVE IN A HEALTH DESERT THE
IDEA OF DIGITAL IS A BRIDGE IS A
MORE NUANCED CONVERSATION ABOUT
EQUITY AND DIVIDE AND THOSE WHO
HAVE INEQUITIES MAY NOT BE
DIGITAL HAVE-NOTS.
FOR MANY DIGITAL IS THE ONLY WAY
THEY REACH.
WE SAW ANOTHER VERY INTERESTING
OUTCOME FROM A STUDY WE'VE BEEN
PARTICIPATING IN THE ASTHMA
TRIAL.
THE BIG TAKEAWAY IN THE
COMMERCIAL POPULATION IF YOU
HAVE COMMERCIAL INSURANCE WHICH
USUALLY MEANS YOU HAVE GOOD
EMPLOYMENT AND SO ON WE DIDN'T
SEE AN EFFECT OF THIS DIGITAL
TOOL WHICH BASICALLY WAS MORE
ABOUT SELF MANAGEMENT BUT IN THE
MEDICAID POPULATION WE HAD 40%
REDUCTION IN E.D. VISITS.
OME IN MEDICAID.
THE INTERESTING THING IS THIS
SUMMARY CAME OUT AND THE LAST
SENTENCE IS IMPORTANT, IF YOU
JUST HAVE THIS BIAS ABOUT
TARGETING DIGITAL TOOLS IN
MEDICAID WE MAY BE EXACERBATING
THE PROBLEM FOR MANY THAT MIGHT
BE A MEDIUM WHERE THEY GET CARE
THEY SIMPLY DON'T HAVE ACCESS TO
OTHERWISE.
WE'RE TALKING ABOUT INTEGRATING
THESE WITH THE U-MASS TEAM BEING
ABLE TO CONDUCT RESEARCH AS PART
AND PARCEL OF CLINICAL CARE
BECAUSE WE'RE GENERATING DATA
AND WORK ON CONSENT AND WHAT ALL
THAT MEANS ON THE REGULATORY
STORY SIDE AND TO SUMMARIZE,
DIGITAL IS COOL.
TIME A CHEERLEADER FOR IT AND
IT'S DOING IMPORTANT THINGS AND
MY OBJECTIVE IN THIS BRIEF
COMMENT WAS TO SHARE A REASON
WHY WE PROBABLY TOUTH DIG IN
DEEP WHEN WE RUN INTO OBSTACLES
WITH OUR OFTEN POLICY PROCESS
REGULATION THE WAY WE'RE
CURRENTLY DESIGN TO SEE BECAUSE
IT'S WORTH IT.
WHEN YOU COME TO THE OTHER SIDE
IT ENHANCES ACCESS FOR MANY WE
HAVE A HARD TIME GETTING TO
OTHERWISE.
>> A LOT OF IMPORTANT THEMES
WE'LL COME BACK TO AND
SELF-EFFICACY, HEALTH EQUITY,
POINT OF CARE BEING THE HOME
SETTING AND ALL THESE THINGS BE
ENABLED BY DIGITAL HEALTH.
IT'S MY PLEASURE TO INTRODUCE
OUR NEXT SPEAKER, DR. MICHAEL
MINA.
HE'S AN EPIDEMIOLOGIST AND
CLINICAL PATHOLOGIST AND WORKS
AT A COMPANY BY LINKING HOME
TEST TO TELEMEDICINE.
I'VE HAD THE PLEASURE OF WORKING
WITH MICHAEL THE PAST ALMOST
YEAR THROUGH THE RADX HOME TEST
TO TREAT PROGRAM WHICH I'M
GUESSING MICHAEL WILL TELL YOU A
BIT ABOUT.
MY PLEASURE TO WELCOME YOU UP,
MICHAEL.
>> THANK YOU FOR THE INVITATION.
I WANT TO TRY TO GIVE A COUPLE
EXAMPLES HOW RAPID TESTS AND
HOME TESTS AND POINT OF CARE
TESTS DON'T NEED TO BE A
COMPROMISE BETWEEN PUBLIC HEALTH
AND CARE AND GIVING PEOPLE
ACCESS.
THAT WAS SOMETHING COMES UP
WHEN A DEVICE BECOMES PART OF
SOMEONE'S LIFE AND WE IMPROVE
PEOPLE'S ABILITIES TO UNDERSTAND
MORE ABOUT THEIR BODY BY TAKING
PHYSICIANS OUT OF THE EQUATION
SOMETIMES AT THE BEGINNING.
I WANT TO TALK FIRST HOW LINKING
HOME TESTS TO PUBLIC HEALTH
PROGRAMS CAN WORK AND HOW IT
DOESN'T NEED TO BE A COMPROMISE
AND HOW LINKING HOME TEST TO
CARE VIA THINGS LIKE HOME TEST
TO TREAT PROGRAM ARE TWO EXAMPLE
TO MAKE A POINT.
IN 2020 TESTING FOR COVID WAS
ESSENTIALLY ENTIRELY LABORATORY
BASED FOR THE MAJORITY OF THE
YEAR AND MAJORITY OF THE TEST
DISTRICTED.
PRIOR TO THE PANDEMIC OF COURSE
HOME TESTING WAS REALLY NICHE.
BARELY EXISTING IN TERMS OF THE
ACTUAL DEVICES THEMSELVES AND
THE TESTS BEING INSIDE PEOPLE'S
HOMES.
VACCINES AND TREATMENTS IN 2020
WEREN'T AVAILABLE.
THE TOOL WE HAD BESIDES LOCKING
SOCIETY DOWN WAS TESTS.
TESTS ARE A WAY TO SEE WHAT'S
OTHERWISE INVISIBLE.
IT'S EYES ON THE VIRUS.
TESTS ARE A WAY TO PUSH THROUGH
A PANDEMIC IN THE EARLIEST DAYS
BEFORE VACCINES AND TREATMENTS.
THERE'S A CLEAR BENEFIT TO
GETTING TEST SCALED AND RADX
IDENTIFIED THE REAL NEED.
WE DIDN'T ALWAYS ACT QUICKLY BUT
RADX MASSIVELY CHANGED THE TIDE
ON WHAT POINT-OF-CARE TESTING
WOUND UP LOOKING LIKE FOR THE
PANDEMIC.
GETTING THE SIMPLE CONCEPTS OUT
IN 2023, 2024 NOW ALMOST FOUR
YEARS IN THE PANDEMIC OR
BEGINNING OF THE PANDEMIC IN
SOME WAYS IT ALMOST FEELS SILLY
ABOUT WHY IS A HOME TEST
IMPORTANT.
2020 IT WAS ESOTERIC.
I REMEMBER TALKING ABOUT IT IN
FEBRUARY, MARCH, 2020 SUGGESTING
WE COULD MAKE TEST FOR UNDER A
DOLLAR AND EVERYONE SHOULD HAVE
ACCESS BASED ON WHAT WE KNOW
ABOUT DENGUE AND MALARIA AND IT
WAS A NOVEL CONCEPT TO MOST.
BUT THERE ARE REAL PUBLIC HEALTH
BENEFITS TO HAVING FAST AND
ACCESSIBLE TESTS AVAILABLE BUT
WE HAD TO GO THROUGH THE RIG AMA
RIGMAROLE OF WHAT WAS KNOWN AND
NOTHING NEW WAS DISCOVERED PER
SE.
I DON'T THINK ANYTHING NEW IS
THROUGHOUT BUT THE MATH HOD OF
HAD TO BE DRAWN OUT TO SHOW IT
AND SHOW SENSITIVITY OF A
PROGRAM RATHER THAN A TEST.
ARE THERE DIFFERENT TESTS THAT
LOCK FAMILIAR TO ONE ANOTHER BUT
ARE THERE COMPLETELY DIFFERENT
USES FOR THE PROGRAM AND THE
QUALITY AND METRICS AROUND TESTS
WERE PARAMOUNT.
A LOT OF THE WORK IN 2020, 2021
WAS DESCRIBING THE NOTION THAT
TESTING CAN HAVE DIFFERENT USES
BASED ON THE LABEL.
FORTUNATELY IN THE POINT IN
HISTORY WE STILL HAVE MORE OR
LESS ONE PATHWAY AND LENS AND
HOPEFULLY THAT WILL CHANGE OVER
TIME.
AS THE PANDEMIC STARTED THERE
WERE MASSIVE BARRIERS TO GETTING
TESTS INTO PEOPLE'S HANDS.
REGULATION WAS ONE OF THEM.
PHYSICIANS, LABORATORY PEOPLE
AND CRITICS WERE THE BARRIERS OF
GETTING TESTS INTO THE HANDS OF
PEOPLE WITH PEOPLE CAN TAKE
OWNERSHIP IN THE PRIVACY OF
THEIR HOME AND IN AN ELECTION
PERIOD WHERE THE MERE FACT THE
VIRUS CIRCULATED THE IDEA
SOMEBODY MIGHT GET TESTED BECAME
HIGHLY POLITICIZED AND HAVING A
TOOL LIKE A HOME RAPID TEST FOR
SOMEONE WHO DOESN'T WANT TO GO
TO A DOCTOR AND INSTEAD USE A
TEST AT HOME THERE WAS SOMETHING
VALUABLE TO HAVING THAT TYPE OF
TOOL THAT IS USEFUL IN ALL
DEMOGRAPHICS.
EVENTUALLY THE BARRIERS STARTED
TO COME DOWN AND LARGELY DOWN
NOW BUT A LOT OF WHAT THE
DISCUSSION IN THE LAST COUPLE
DAYS HAS BEEN ABOUT HAS BEEN
ABOUT CONNECTING THE TOOLS.
IN AUGUST 2020 ABBOTT GOT THIS
THROUGH FOR PROFESSIONAL USE AND
IF THEY GO HOME YOU LOSE
VERIFICATION OF WHO USED THE
TEST EVEN FIT WAS REPORTED.
THERE WAS CONCERN PEOPLE
WOULDN'T KNOW HOW TO PUT A SWAB
IN THEIR NOSE OR PERFORM A TEST.
THESE WERE REAL CONCERNS AT THE
TILE.
IN GENERAL THE WORLD'S
POPULATION HAS BEEN EDUCATED
WELL ENOUGH BECAUSE OF THE
EXISTENCE OF THE TESTS SO THOSE
CONCERNS HAVE LARGELY FALLEN
AWAY SOME OF THEM BUT CONNECTING
TO PUBLIC HEALTH IS A DOWN FALL
OF GETTING MILLIONS OF TESTS
INTO PEOPLE'S HOMES FOR FREE WE
STARTED TO LOSE A LENS ON THE
PANDEMIC.
I WOULD ARGUE WE'RE ALREADY IN A
MASSIVIVELY BIASSED WORLD WHEN
YOU DON'T GREAT EASY ACCESS TO
THE LABORATORY-BASED TESTS IN
THE FIRST PLACE BUT THAT'S A
SLIGHTLY DIFFERENT STORY.
TO START SOLVING THE PROBLEM AND
START THINKING HOW CAN WE TAKE A
POINT OF CARE DEVICE.
THESE ARE DESIGN TO BE IN
SOMEBODY'S BATHROOM CUPBOARDS.
THEY'RE SIMPLE.
THEY DON'T HAVE INSTRUMENTATION.
HOW CAN WE GET THEM TO REPRESENT
POINT OF CARE THAT FITS INTO THE
CONSTRUCTS WE'VE DEVELOPED FOR
PUBLIC HEALTH REPORTING WITHOUT
ALL THE OVERHEAD OF HAVING A
HEAVY DEVICE.
ABBOTT AND EMED GOT TOGETHER AND
SAID MAYBE WE CAN TAKE THIS KIT
AND LINK IT THROUGH DIGITAL
HEALTH AND TELEHEALTH PROCCING
FOR -- PROCTORING SO PEOPLE CAN
SCAN A QR CODE AND ALL OF A
SUDDEN THE SPACE BETWEEN THE
COMPUTER AND PERSON BECOMES A
DIGITAL POINT OF CARE SETTING
AND THE FDA SEEMED OPEN TO THAT
IDEA.
AND THERE'S AN IS SIMPLE FORMAT
WITHOUT INSTRUMENTATION WAS THE
COMBINATION OF ABBOTT'S BINEX
AND EMED PROCTORING AND DIGITAL
POINT OF CARE ENVIRONMENT.
THE EUA WAS GIVEN IN LATE 2020
AS FIRST PRESCRIBED COVID
ANTIGEN TEST AND GLAD THE NOTION
OF A PRESCRIPTION FOR A TEST HAS
FALLEN AWAY AND BROUGHT THE
POINT-OF-CARE DEVICE INTO THE
PRIVACY OF THEIR OWN HOME.
RATHER THAN DIVING INTO SOFTWARE
AND LEVERAGED CONNECTING PEOPLE
THROUGH CALL CENTERS IN A
DISTRIBUTED FASHION AND SCALABLE
FASHION SO THAT 24/7 SOMEBODY
CAN SCAN THE QR AND A TELEHEALTH
PROCTOR WOULD BE ON THE SIDE OF
YOUR PHONE OR COMPUTER AND
PEOPLE DIDN'T WANT TO SEE THE
PERSON WATCHING THEM.
THEY JUST WANTED TO HEAR THE
INSTRUCTIONS AND WE'RE USED TO
LOOKING AT FACETIME AND HALF
TIME WE'RE LOOKING AT OURSELVES
IN THE LITTLE BOX INSTEAD OF THE
PERSON WITH THE BIG BOX AND
PEOPLE ARE SO COMFORTABLE THEY'D
RATHER SEE THEMSELVES IN THE
LITTLE BOX THAN THEIR TELEHEALTH
PROCTOR.
IT WAS A COMFORTABLE SETTING FOR
PEOPLE TO SEA SCAN THIS AND SEE
YOURSELF USING IT AND ON THE
OTHER SIDE A REAL PERSON WALKS
YOU THROUGH THE INDIVIDUAL STEPS
HOW TO USE THE TEST.
BEFORE THAT THEY'VE CHECKED YOUR
I.D. AND WANT TO MAKE SURE YOU
ARE WHO YOU SAY YOU ARE AND IB A
LOCATION YOU SAY YOU'RE AT FOR
PUBLIC HEALTH REPORTING.
WE WENT THROUGH ALL THE STEPS
THAT WOULD NORMALLY BE REQUIRED
TO PUSH A RESULT TO A PUBLIC
HEALTH AGENCY.
WE WERE ABLE TO DO THAT ENTIRELY
IN THE HOME.
THIS ALLOWED REAL-HEALTH
REPORTING AND USUALLY WITHIN 20
MINUTES WE GO FROM STARTING A
TEST TO HAVING THE RESULT SHOW
IN A PUBLIC HEALTH AGENCY'S
HANDS THAT WAS ACROSS ALL 50
STATES.
SO THIS DOESN'T NEED TO BE A
TRADE-OFF.
IF WE WANT TO PUT A BINEX NOW
TEST THAT WILL CHEAP TO MAKE AND
HAVE NO CONNECTIVITY IN THEIR
MANUFACTURING OBSTRUCTION AND
BRING THEM TO A MORE SECURE
CHANNEL SO AGENCIES FEEL
COMFORTABLE TAKING THAT RESULT
RATHER THAN HOSTING AND TRUSTING
SOMEBODY IS REPORTING
ACCURATELY.
WE HAVE THE TOOLS AT OUR
DISPOSAL.
THIS ENABLED TESTING GLOBALLY.
THE REPORTING WAS IN THE
U.S. AND UTILIZING THE TESTS IN
THE UNITED STATES BUT WHAT WE
FOUND WAS ONE OF THE MOST
IMPORTANT USES WAS PEOPLE WOULD
THROW ONE OR TWO IN A SUITCASE
WHEN THEY TRAVELLED
INTERNATIONALLY.
WE WOULD THEN BE ABLE TO GIVE A
VERIFIED LABORATORY REPORT THAT
IS SAYS WE CHECKED AND THIS IS
THE REALITY PERSON AND ACTUAL
RESULT AND CAN GIVE THEM THE
EQUIVALENT OF A LABORATORY THAT
VERIFIED WHO THEY WERE AND WHAT
THE RESULT WAS.
IMPORTANTLY FROM AN FDA AND
REGULATORY PERSPECTIVE WE HAD
THE INDIVIDUAL READ TO THE
PROCTOR WHAT THE RESULT WAS BUT
ALSO HOLD UP THE TESTS THE
PROCTOR COULD SEE IT.
ALL THIS WAS RECORDED AND TAKE
IMAGES AND IF THERE'S A
DISCREPANCY PEOPLE WOULD WHITE
OUT THEIR LINES TO TRAVEL.
IF THERE'S A DISCREPANCY WITH
WHAT THE PROCTER SAW AND I WAS
INVALID AND DIDN'T HAVE ALL
RIGHT THAT IT WAS JUST INVALID.
THERE'S NICE FLEXIBILITIES THAT
CAME ABOUT IN THE EARLIEST DAYS
OF GETTING THE TESTS INTO
PEOPLE'S HOMES.
IT LED TO MILLIONS TO TRAVEL
NATIONALLY AND ALLOWED MILLIONS
MORE TO GET BACK TO SCHOOL AND
THE LAB REPORT WOULD BE
POSITIVES AND NEGATIVES TO THE
PUBLIC HEALTH AGENCIES AND THE
SCHOOL SYSTEM OR WHOEVER WAS
SUPPORTING THE PARTICULAR
PROGRAM.
IF YOU GO TO WALGREENS YOU DON'T
GET A REPORT THAT SAYS THIS
PERSON IS HERE BECAUSE THEY WANT
TO GO TO A WEDDING OR SCHOOL.
YOU DON'T KNOW HOW TO INTERPRET
POSITIVE AND NEGATIVE RATES WHEN
YOU DON'T KNOW WHY PEOPLE ARE
COMING TO TEST IN THE FIRST
PLACE.
IF TESTING IS ASYMPTOMATIC YOU
CAN HAVE A POPULATION PREVALENCE
OF 1% AND KNOWING WHY PEOPLE ARE
POSITIVE OR TESTING IN THE FIRST
PLACE IS PARAMOUNT TO BEING ABLE
TO MAKE SENSE OF THE DATA WE DID
HORRIBLY ACROSS THE WORLD.
PEOPLE WERE TRYING TO EXTRACT
FROM MESSY DATA WHAT THAT MEANT
AND HAD GOVERNORS AND MAYORS AND
KINGS MAKING IMPORTANT DECISIONS
FOR SOCIETY WHEN IT WAS
IMPOSSIBLE TO INTERPRET.
WE SAW PUBLIC HEALTH AGENCIES
REVOLT AND WE SAID IT'S MORE OF
A POINT OF CARE TEST THAN PURE
HOME TEST.
SOME OF THE PUBLIC HEALTH
AGENCIES DID ASK US TO STOP
SENDING DATA TO THEM AND THESE
ARE TOUGH PROBLEMS TO CONTEND
WITH AND FOR EVERY TEST YOU GET
WHY ARE YOU TESTING AND SOME WE
DIDN'T HAVE TO ASK.
AS PART OF SCHOOL PROGRAMS WE
KNEW AND GOT INTERESTING THINGS
LIKE DEVICE USE TO BETTER
UNDERSTAND WHO THE POPULATIONS
WERE THAT WERE GETTING THE
RESULTS FROM.
THAT'S PUBLIC HEALTH REPORTING.
THE OTHER BIG ISSUE WAS WHAT ARE
WE GOING TO DO AND THIS IS FOR
EVERYTHING IN THE POINT OF CARE
SPACE GETTING IN THE HOME.
THE CONUNDRUM IS WHAT DO WE DO
IF SOMEONE IS POSITIVE.
WE DON'T WANT TO LEAVE SOMEBODY
WITH GONORRHEA OR CHLAMYDIA
WITHOUT ACCESS TO CARE.
THAT'S FROWNED UPON AT THIS TIME
AND BUILD NEW TOOLS AND
APPROACHES TO DEAL WITH THIS.
AS A RESULT OF THIS THINKING,
CDC AND UNIVERSITY OF
MASSACHUSETTS AND OTHERS HAVE
BEEN LEARNING MORE HOW
INDIVIDUALS UTILIZE TELEHEALTH
AND HOW CAN WE CONTINUE TO REACH
MORE VULNERABLE POPULATIONS WITH
TELEPROGRAMS.
IN THE NEW ADMINISTRATION THE
TEST TO TREAT WAS ANNOUNCED.
THERE'S BARRIERS AND GET PEOPLE
TREATMENT QUICKLY.
THE IDEA OF PUTTING ALL OF THESE
TEST TO TREAT LOCATIONS IN BRICK
AND MORTAR LOCATIONS DIDN'T
SOLVE THE PROBLEMS AND IN MANY
STATES THEY WERE IN A LOCATION
BUT MANY LIVE RURALLY SO IT'S
DIFFICULT TO GET TO THOSE SITES.
THERE'S A CLEAR PATHWAY IF WE
SAID HOW DO WE BRING THEM TO
THEM AND IT'S A PUBLIC HEALTH
PROGRAM AND IT'S NOW BEEN
STARTING SINCE JANUARY, FEBRUARY
OF '23 WE INITIATED IT AND HAVE
BEEN BUILDING IT UP EVERY SINCE
AND HAVE A NATIONWIDE PROGRAM
AND SOMEBODY WAKES UP WITH
SYMPTOMS AND TEST AND GET A
PRESCRIPTION WITHIN A FEW HOURS
RATHER THAN DAYS IT TAKES TO
MAKE THE APPOINTMENT TO GET THE
PCR AND GET IT TO THE LAB AND
PUTTING PEOPLE BEYOND THE
THERAPEUTIC WINDOW IN THE FIRST
PLACE.
THE NICE THING ABOUT RUNNING
DIGITAL PROGRAMS IS YOU GET
THEY'LL DASHBOARDS WE'VE HEARD
ABOUT AND GET LOTS OF
INFORMATION IN TIME.
HERE WE'RE GETTING WHO IS
GETTING TREATMENT, WHY, ARE THEY
NEEDING FOLLOW-UP, ARE THEY
GOING TO OTHER PHYSICIANS AND
REGISTERING IN OTHER PROGRAMS.
WE CAN FOLLOW LOTS OF PIECES OF
INFORMATION OTHERWISE HARD TO
GET.
WE'RE HOPING TO RUN IT THROUGH
2024 AND IF YOU'RE POSITIVE AT
THE TIME OF ENROLLMENT ANYONE
OVER THE AGE OF 18 CAN ENROLL
AND IF YOU'RE NOT POSITIVE WE
TRY TO IDENTIFY PEOPLE MEDICARE
AND MEDICAID UNDER INSURED
INDIVIDUALS AND OTHERS AND
ENROLL THEM AND WE SEND THEM
TESTS TO THEIR HOME IN THAT CASE
AND GOING TO BE LAUNCHING A
COVID AND INFLUENZA PROGRAM
EXPANDING BEYOND JUST COVID.
TO CONCLUDE, HOME TESTING
DOESN'T NEED TO BE THE TRADE-OFF
BETWEEN PUBLIC HEALTH OR THE
TEST INTEGRITY AND DOWN STREAM
USE.
WE CAN GET HOME TESTING INTO
PEOPLE'S HOMES AND STILL CATCH
WHAT WE GET FROM POINT OF CARE
SITE OR CLINIC AND CONNECT TO
CARE AND THESE ARE TWO EXAMPLES
OF THAT.
>> I'LL INTRODUCE OUR THIRD
SPEAKER, DR. POOJA JANI A PUBLIC
HEALTH LEADER WITH EXPERIENCE IN
INTERVENTIONS AND IMPROVED
POPULATION HEALTH AND
STRENGTHENED HEALTH SYSTEMS.
SHE'S CURRENTLY A MEDICAL
OFFICER IN THE OFFICE OF IN
VITRO DIAGNOSTICS AT THE FDA
WHERE SHE PROVIDES STRATEGIC
OVERSIGHT AND EXECUTION ACROSS
THE DATA PROGRAM AND WILL TELL
YOU ALL ABOUT THE DIAGNOSTIC
DATA PROGRAM.
COME ON UP, POOJA.
I'M HERE TO GIVE A BRIEF
OVERVIEW ON THE DIAGNOSTIC DATA
PROGRAM.
AND WHAT WE'RE AIMING TO DO WITH
REGARDS TO DIAGNOSTIC DATA FOR
THE AGENCY I WANT TO START WITH
THE OVERVIEW OF CURRENT
CHALLENGES BY OUTLINING A
SCENARIO THAT PLAYED OUT MANY
TIMES DURING THE COVID PANDEMIC.
I'M NOT GOING TO WALK THROUGH
THE ENTIRE PATIENT JOURNEY.
THIS SLIDE IS IS SUPPOSED TO
DEMONSTRATE A SCENARIO WHERE A
PATIENT THINK THEY HAVE COVID-19
AND TAKE A LOT OF TESTS AND
THOUGH A BUNCH OF TESTS ARE
TAKEN, VERY FEW ARE REPORTED.
THIS IS FAMILIAR STORY AND
HIGHLIGHTS TWO MAIN CHALLENGES
WITH DIAGNOSTIC DATA.
IF WE LOOK AT THE SCENARIO FROM
THE PUBLIC HEALTH PERSPECTIVE
THE ONLY INFORMATION AVAILABLE
TO PUBLIC HEALTH AUTHORITIES IS
WHAT'S ABOVE THE CENTER LINE
WHICH ARE THE LAB-BASED PCR
TESTS HIGHLIGHTED IN BLUE.
IN THIS EXAMPLE WE DON'T KNOW
ANYTHING ABOUT THIS PERSON.
WHEN THEY'RE FIRST EXPOSURE MAY
HAVE BEEN OR FIRST TESTED OR WHY
THEY TOOK THE TESTS.
ALL WE KNOW IS THE PERSON TOOK
TWO PCR TESTS, ONE POSITIVE AND
ONE NEGATIVE.
ALL THE OTC TESTS IN YELLOW ARE
INVISIBLE TO US.
IN THIS EXAMPLE OF THE SIX TOTAL
TESTS CONDUCTED, ONLY TWO OF
THOSE TESTS WERE ACTUALLY
REPORTED.
THAT'S CHALLENGE NUMBER ONE.
THEN CHALLENGE NUMBER TWO IS IF
WE LOOK MORE CLOSELY AT THE TWO
PCR TESTS WE'LL SEE
INCONSISTENCIES SO WE CAN'T
ALWAYS TRUST THE DATA BEING
REPORTED TO US AT FDA.
SO THEN THIS SLIDE ILLUSTRATES
THE TWO CHALLENGES.
PROBLEM ONE IS THAT WE'RE NOT
SEEING INFORMATION ON MOST TESTS
BEING PERFORMED.
WE HAVE FOUND INFORMATION
THATCYTES FROM -- THAT CITES THE
TESTS PRODUCED BY FOUR
MANUFACTURERS WERE ABLE TO BE
FULLY CAPTURED AND REPORTED.
THAT'S OUT OF A TOTAL 2.6
BILLION TESTS MANUFACTURED
DURING THAT TIME PERIOD MEANING
WE'RE SEEING LESS THAN 1% OF
WHAT'S HAPPENING WITH TESTS
PERFORMED OVER THE COUNTER.
THE 2.6 BILLION NUMBER ARE THE
NUMBER OF TESTS MANUFACTURED NOT
TAKEN WHICH WE HAVE NO WAY OF
KNOWING.
AND PROBLEM TWO WITH THE TESTS
BEING CONDUCTED IN TRADITIONAL
LABS, WE HAVE ACCESS TO
APPROXIMATELY 99% OF THE DATA
BEING CAPTURED AND REPORTED BUT
THE QUALITY IS INCONSISTENT.
LAB DATA IS SIMPLE TO TRANSMIT
BUT CHALLENGE TO EVALUATE
BECAUSE THERE'S NON-STANDARDIZED
CODING PRACTICES BY LABS AND
ELECTRONIC HEALTH RECORDS.
WHEN RESEARCHERS CONDUCTED AN
EVALUATION THEY FOUND DATA
MAINTAINED ONLY 59% INTEGRITY
MOVING THROUGH THE SYSTEMS.
I'M NOT HIGHLIGHTING ISSUES AT
THE LAB BENCH BUT RATHER WITH
HOW THERE'S INCONSISTENT NAMING
PRACTICES TO MAKE IT DIFFICULT
TO KNOW WHEN DIFFERENT TESTS ARE
PERFORMED BETWEEN DIFFERENT
LABS.
WHAT'S THAT MEAN FOR FDA?
FOR PROBLEM ONE IN THE SPACE OUR
INABILITY TO COLLECT A CRITICAL
MASS OF REAL-WORLD DATA MEANS
FDA IS FORCED TO MAKE REGULATORY
DECISIONS WITHOUT KNOWING THE
REAL WORLD PERFORMANCE OF THESE
TESTS.
IN THE FUTURE WE WOULD LIKE TO
GET TO A PLACE WHERE REAL-WORLD
DATA IS ABLE TO HELP FDA MAKE
WELL-INFORMED REGULATORY
DECISIONS BUT CAN'T DO THAT
WITHOUT THE FULL PICTURE.
FOR PROBLEM TWO THE LACK OF
INTEGRITY IN THE REAL WORLD DATA
MEANS WE'RE OPERATING ON LIMITED
INFORMATION REGARDING
PERFORMANCE AND WE CAN'T ALWAYS
TRUST THE DECISIONS THAT WE'RE
MAKING BASED ON THE INCOMPLETE
INFORMATION.
SO IN THE FUTURE, WE WANT REAL
WORLD DATA TO HELP FDA TO
EXPEDITE QUALITY TESTING
PRACTICES, ENHANCE CLINICAL CARE
AND IMPROVE POLICY AND DEVICE
APPROVAL DECISIONS BUT THIS REAL
WORLD DATA NEEDS TO MEET A HIGH
STANDARD OF REGULATORY GRAY DATA
TO BE CONFIDENT WE'RE MAKING
GOOD DECISIONS BASED ON GOOD
DATA.
IT'S THESE CHALLENGE INSPIRE THE
CREATION OF OUR PROGRAM AT FDA
INCLUDING TWO ARMS FOCUSSED ON
IMPROVING THE COLLECTION,
USABILITY AND PORTABILITY OF
DATA COMING FROM BOTH INSIDE AND
OUTSIDE CLINICAL LABS.
THE FIRST ARM IS FOCUSSED ON
IMPROVING DIAGNOSTIC DATA
COLLECTION WHERE OUR TEAM IS
WORKING WITH THE TESTING
COMMUNITY TO DEVELOP INNOVATIVE
METHODS AND SOLVE TECHNOLOGY
CHALLENGES REGARDING DATA
CAPTURE AT THE POINT-OF-CARE AND
TRANSMITTING DATA TO FDA TO
DEMONSTRATE THE UTILITY IN
REGULATORY DECISION MAKING AND
THE SECOND ARM IS FOCUSSED ON
ENHANCING LAB DATA QUALITY
THROUGH THE SHIELD PROGRAM.
WHICH IS WORKING ON IMPROVING
HOW LAB DATA INTEROPERABILITY IS
MANAGED.
THEY'RE DEVELOPING A QUALITY
INSURANCE PROGRAM AND THE
ACCURACY OF LAB TESTS.
AS WE IMPORTANT TO KNOW IS BOTH
LANES OF THE EFFORT ARE HIGHLY
COMPLEX.
TO BE SUCCESSFUL, FDA NEEDS TO
CONTINUE WORKING IN CLOSE
COLLABORATION WITH THE CREATORS,
STEWARDS AND THE OF DIAGNOSTIC
DATA.
WITH REGARDS TO THE ONE ARM THE
IN VITRO TESTS TRADITIONALLY
PERFORMED INSIDE LABS ARE
INCREASINGLY MOVING OUTSIDE LABS
AND BECOMING UNTETHERED FROM
THEIR REPORTING MECHANISMS AND
THE COVID-19 MECHANISM
ESTABLISHED THE TREND.
IT'S LIKELY TO CONTINUE AS OTHER
TESTS GOOD OVER THE COUNTER IN
THE COMING YEARS.
WHILE THERE'S BENEFITS TO OTC
TESTING LIKE THE CONVENIENCE AND
AFFORDABILITY OF BEING ABLE TO
TEST AT HOME THERE'S BIG
LIMITATIONS IN OUR ABILITY TO
CAPTURE AND TRANSMIT INCREASING
VOLUMES OF DATA THAT ARE BEING
GENERATED BY THESE TESTS SO THAT
PHYSICIANS AND PUBLIC HEALTH
LEADERS CAN MAKE EVIDENCE-BASED
DECISIONS FOR INDIVIDUAL
CLINICAL CARE AS WELL AS
POPULATION HEALTH USING THE
DATA.
FOR EXAMPLE, OVER THE PAST
SEVERAL YEARS THERE'S BEEN
SUBSTANTIAL DIFFERENCES IN TEST
RESULT DATA BETWEEN LAB-BASED
AND OTPCO TESTS WHICH HIGHLIGHTS
THERE'S A REAL NEED TO
UNDERSTAND AND ADDRESS HOW
DIFFERENT TESTS ARE BEING USED
AND REPORTED.
THEN THE OTCPO SIDE OF THE
PROGRAM HAS FOCUS AREAS
INCLUDING SOFTWARE AND HOW WE
MIGHT BE ABLE TO REGULATE
SOFTWARE AS A MEDICAL DEVICE
WHEN COUPLED WITH IEDs, CYBER
SECURITY, DIGITAL VISUALIZATION
ALGORITHMS LIKE DIGITAL READERS
FOR LATERAL FLOW TESTS, DATA
HARMONIZATION, QUALITY AND
UTILITY IN THE CONTEXT OF DATA
CAPTURED FROM OTCPOC TESTS THE
CONVERGENCE OF TECHNOLOGIES
INCLUDING DIGITAL APPS AND
WEBSITES AND OTHER TOOLS HEALTH
CARE SYSTEMS MIGHT USE TO PULL
TOGETHER CLINICAL AND TESTING
DATA AND OF COURSE CONSIDERING
THE OVER ALL IMPACTS THE TESTS
HAVE ON CLINICAL AND PUBLIC
HEALTH.
AND A COLLABORATIVE COMMUNITY OF
OVER 130 REPRESENTATIVES FOR
MORE THAN 75 ORGANIZATIONS
ACROSS THE PUBLIC AND PRIVATE
SECTORS TO DEVELOP A
COMPREHENSIVE SOLUTION THAT
ADDRESSES CLINICAL AND DEVICE
INTEROPERABILITY FOR IEDs
NATIONWIDE.
THIS INCLUDES THE FLOW OF DATA
THROUGH THE ENTIRE LAB DATA LIFE
CYCLE MEANING THE EXCHANGE OF
DATA FROM STANDARDS
ORGANIZATIONS TO DEVICES AND LAB
WORK STATIONS TO EHRs.
THROUGH THE INNOVATIVE
HARMONIZATION THE SHIELD
COMMUNITY IS WORKING TO DEVELOP
A PLATFORM THAT IMPROVES THE
QUALITY AND PORTABILITY OF LAB
DATA WITH THE GOAL OF REDUCING
RISKS TO PATIENT SAFETY.
THE CHALLENGE THE SHIELD PROGRAM
ARE ADDRESSING ARE HIGHLY
COMPLEX AND CENTER AROUND FOUR
FOCUS AREAS.
ECO SYSTEM ENGAGEMENT INCLUDING
COLLABORATING ACROSS THE LAB
DATA ECO SYSTEM AND EDUCATING
STAKEHOLDERS ABOUT LAB DATA
INTEROPERABILITY AND ENHANCED
DATA ANALYTIC STORAGE DEVELOPING
AN AUTHORITATIVE SOURCE FOR LAB
DATA REPRESENTATION THAT CAN
USED BY EVERYONE WHO CREATES OR
USES LAB DATA AND SYSTEMS
THINKING WHICH INCLUDES
REENGINEERING THE LAB DATA
TRANSFER PROCESS IN A WAY THAT
PRIORITIZES PATIENT SAFETY AND
AND KNOWLEDGE MANAGEMENT AN
INTEGRATED APPROACH DEALING WITH
LAB DATA SO IT'S UNDERSTANDABLE
AND REPRODUCIBLE AND WHILE THE
OBJECTIVES OF OUR PROGRAM ARE
MEANT TO IMPROVE FDAs ABILITY TO
BETTER REGULATE DIAGNOSTIC TESTS
THROUGH HIGHER QUALITY DATA OUR
LARGER OBJECTIVE IS TO IMPACT
THE BROADER ECO SYSTEM BY
DEVELOPING A ROBUST
INFRASTRUCTURE TO IMPROVE THE
DIAGNOSTIC DATA IN AND BETWEEN
INSTITUTIONS AND INDIVIDUALS.
AND SO WE HOPE THAT THESE
EFFORTS WILL CREATE BETTER DATA
FOR PUBLIC HEALTH REPORTING,
IMPROVE PATIENT SAFETY, SUPPORT
TEST DEVELOPERS AND REGULATORY
SUBMISSIONS AND ENHANCE OVER ALL
HEALTH ANALYTICS.
WITH THAT I WILL HAND IT BACK TO
ANDREW.
>> I WANT TO INVITE ALL THREE OF
OUR SPEAKERS BACK UP AND WE DO
HAVE TIME FOR QUESTIONS.
>> I WAS WONDERING IF THERE'S A
TIME LINE FOR THIS PROJECT TO
REACH SOME KIND OF
STANDARDIZATION?
IS THERE A FIVE YEAR TIME LINE
OR WHAT KIND OF GOAL IS THERE TO
MAKE SURE ALL THESE TESTS ARE
BEING REPORTED IN THE SAME WAY
AND ARE TRACKABLE.
>> CURRENTLY OUR PROGRAM IS
FUNDED THROUGH THE END OF NEXT
YEAR.
WE DID EARLIER THIS SUMMER WE
CAME UP AGAINST SOME FUNDING
RESCISSIONS AND SO WE'RE HOPING
IF THAT FUNDING COMES BACK TO US
THROUGH HHS THEN THAT MIGHT
EXTEND US TO 2025.
I'LL ALSO SAY THE SHIELD PROGRAM
HAS BEEN AROUND A LOT LONGER
THAN THE DIAGNOSTIC DATA PROGRAM
SO IT ACTUALLY GOT FOLDED IN AS
THE SECOND ARM IN OUR PROGRAM.
SO I THINK SHIELD HAS BEEN
AROUND SINCE 2018.
AND SO I DO THINK IT'S GOING TO
BECOME A PROGRAM THAT GETS
ROOTED WITHIN CDRH AND HOUSED
ELSEWHERE AND BECOME A LONGER
TERM ENDEAVOR.
>> DO YOU THINK IT'S POSSIBLE TO
GET ALL OF INDUSTRY ON BOARD
WITH THE STANDARDIZED CODINGS
WIN THREE YEARS?
-- WITHIN THREE YEARS?
>> THERE'S MULTIPLE I NINK THE
INFORMATICS AND CODE BEING BEING
USED IN THE KNOWLEDGE MANAGEMENT
ARCHITECTURE THEY'RE BUILDING I
THINK THERE'S MULTIPLE LAYERS
THEY'RE BUILDING OUT.
I DON'T THINK THAT'S SOMETHING
THAT CAN BE ACCOMPLISHED WITHIN
THREE YEARS BUT I THINK THEY'RE
LAYING AT LEAST THE FOUNDATION
AND IT WILL BE A LONGER TERM
BUILD, YEAH.
>> THANK YOU VERY MUCH.
>> THANK YOU FOR YOUR
PRESENTATIONS.
VIK AND MICHAEL YOU TOOK ME BACK
TO THE EARLY DAYS OF THE TRAUMA
OF MANY OF THE BATTLES WE FOUGHT
AND VIK'S THINKING ABOUT OUR
FIRST CONVERSATION I THINK IN
FEBRUARY OR MARCH WE THOUGHT
OKAY DIGITAL HEALTH PLATFORMS
PEOPLE WERE GOING TO USE THEM
THEY HAD TO HAVE PERSONAL
BENEFIT AND THE SECONDARY
COMPONENT PEOPLE FELT LIKE THEY
WERE GETTING SOMETHING THEN
PUBLIC HEALTH WOULD BENEFIT AS
WELL IF WE CAN MAKE IT ACCURATE
AND RELIABLE AND WHAT YOU GUYS
ALL PRESENTED IS PROBABLY THE
BIGGEST INCURSION OR PUSH WITH
DIGITAL HEALTH PLATFORMS AND
TOOLS AT SCALE.
WE'RE SO CLOSE.
I WANT TO SAY LET'S KEEP GOING
BECAUSE WE'RE REALLY CLOSE.
FDA IS OBVIOUSLY CLEARLY
COMMITTED TO THIS AS A STRONG
PARTNER BUT MAYBE I CAN REDUCE
EVERYTHING AND GO BACK A LITTLE
BIT.
MIKE, YOU BROUGHT UP THE
PRESCRIPTION TEST.
AT ONE TIME EVERYONE WAS
ADVOCATING, NO, NO, NO, DON'T DO
TESTS AT HOME.
PRESCRIPTION IS OKAY AS LONG AS
THERE'S A HEALTH CARE
PROFESSIONAL INVOLVED TO MAKE
SURE SOMETHING WASN'T GETTING
SCREWED UP BET THE ENORMOUS
POWER OF BILLIONS OF PEOPLE
TESTING IF THEY COULD DO IT WITH
CREDIT IN THEIR HEALTH CARE
SYSTEM.
HAVE THE ELECTRONIC HEALTH
RECORD.
IT'S SEDUCTIVE AND MANAGED AND
GOOD AT BILLING.
DO YOU SEE WHERE POINT-OF-CARE
TESTS AND WE'RE CLOSE WITH
INFECTIOUS DISEASE TEST AND
OTHER TESTS COMING DOWN THE PIKE
BUILT ON THE BEAUTIFUL
PLATFORMS, MANY UPSTAIRS.
COULD THEY GET IN THE E.H.R. AND
CREATE BILLING CODES OR
TRANSACTIONS THAT COULD COMPEL
PEOPLE TO DO THESE THINGS FOR
PERSONAL BENEFIT AS WELL, GET
HEALTH CARE DELIVERY AND THEN
YOU HAVE FULLY GONE OVER THE
HUMP OF DISRUPTION OR ARE WE
FOREVER GOING TO BE DISCONNECTED
WITH THE TEST AND THE OFFICIAL
HEALTH CARE SYSTEM AND WEND UP
AS POOJA SHOWED AS THE BOTTOM
LINE INVISIBLE WITH THE TRUE
INFORMATION ABOUT THE
INDIVIDUAL.
>> THE INTERESTING THING IS IN
ALL THE COMMENTS ONE THING THAT
HAS NOT EMERGE D IS WE
UNDERESTIMATED THE CONSUMER.
THE WORSE FEARS IS THEY WOULDN'T
KNOW HOW TO USE THE TESTS AND DO
SOMETHING WITH THEM SO WHILE
THERE'S CASES OF THE CONSUMER
READING THE TEST RESULT AND IT'S
NOT THE SAME READ AS THE PROCTOR
AND WE CALL THAT AN INVALID TEST
BUT ON AVERAGE I THINK THE
CONSUMERS ARE PRETTY LITERATE IN
BEING ABLE TO DO IT.
THOSE WHO CHOOSE TO USE THE
TESTS AND NOT EVERYBODY'S THE
SAME.
THAT'S THE GOOD NEWS STORY.
THE SECOND IS WE DID
MANUFACTURING BILLIONS OF THESE
AND WE MADE DECISIONS HOW CLOSE
TO SIT TO EACH OTHER AND
VISITING EACH OTHER AND IT'S A
DIFFERENT DEFINITION AS PUBLIC
HEALTH AS WE TEND TO THINK BIT.
OUR VISIBILITY HAS BEEN
DIMINISHED AND IN THE BROADER
ARC OF WHAT'S GOING ON, THAT'S
THE SMALLER PROBLEM.
I THINK WHAT WE'VE ACHIEVED IS A
BIGGER IMPACT WHICH IS MORE
PEOPLE KNOW WHAT THEY'RE DOING
ABOUT THEIR HEALTH.
THE SECOND PART OF WHAT'S IN IT
FOR ME WE OBSESS ABOUT, WHAT
WE'RE SEEING IS THERE'S A LOT
CONSUMERS GET BY DOING THINGS
FOR THEMSELVES.
THEY'RE USING IT SO WE HAVE
ADOPTION AND USE.
USUALLY THOSE ARE THE HARD
THINGS TO ACHIEVE.
WHAT WE'RE LOOKING IN IS MAKING
A CASE TO WHAT VALUE DO THEY GET
BY REPORTING IT TO PUBLIC HEALTH
WHICH I THINK IS A DIFFERENT
MATTER WHICH IS PUBLIC HEALTH TO
REFRAME THE ROLE AND SAY WE'RE
LESS IB CONTROL BY RELYING ON
THE CONSUMER HAVING TO GO TO AN
ENTITY UNDER CLIA IS MANDATORY
REPORTING AND THAT'S HOW THE
SYSTEMS ARE DESIGN.
WHAT I THINK WE'RE NOT ANSWERING
EFFECTIVELY IS WHAT DO I GET AS
A WILL HAVE YOU BACK BY ALLOWING
THE TEST TO BE REPORTED AND WE
CAN INCENTIVIZE IT AND YOU HAVE
TO GET TO THE RIGHT QUESTION AND
PART OF THE ANSWER IS TO MAKE A
CASE FROM PUBLIC HEALTH WHAT
THEY DO.
THEY CAN'T BE IN THE BACKGROUND.
AND ONE OF THE THINGS IS CONTACT
TRACING.
SO THE TYPICAL THINGS WE OBSESS
ABOUT WITHIN PUBLIC HEALTH AND
SO ON MIGHT ACTUALLY BE DESTINE
S
DISINCENTIVES AND CAN RIGHT-SIZE
RESOURCES.
HOW MANY LOCATIONS SHOULD EXIST
AND A CONSUMER WILL SAY HOW WITH
REUSING THE DATA AND WOULD LIKE
TO REPORT IT.
WE'RE BASICALLY SAYING OUR TOOLS
ARE BROKEN.
OUR REPORTING ISN'T WORKING AND
YOU SHOULD DO IT FOR THAT REASON
AND I DON'T THINK THEY CARE.
>> WILL THE INFECTIOUS DISEASES
MAKE THEIR WAY AND IT'S ALL
ABOUT REIMBURSEMENT IN THE
UNITED STATES.
ANYONE COULD BE AND THE THERE'S
AN ASSOCIATION ENGAGED WITH
TRYING TO FIGURE OUT HOW TO GET
APPROPRIATE REIMBURSEMENT AND
THAT WILL GET THEM IN EMRs AND
MAKE THEM A CORPS PART OF OUR
SYSTEM.
I THINK EVERYONE HERE SEES IT
BUT I SEE A LOT OF COMPANIES
FLOUNDERING AROUND WILL IT HIT
BE A CASH-PAY MODEL AND AT THE
END OF THE DAY THE PATIENT WILL
GO TO THE DOCTOR LOOKING AT A
$70 TEST THAT'S CASH.
WE WE ALL HAVE TO PAY FOR
INSURANCE.
WE'RE PART OF CMS AND MEDICARE
AND MEDICAID AND OTHERS AND IT'S
A MATTER OF GETTING THESE
THROUGH.
ALL THE MONEY -- IF CMS STARTS
WE WANT TO REIMBURSE THESE AND
THINK THEY'RE IMPORTANT ENOUGH
THEY'LL BECOME PART OF OUR
LEXICON OF HEALTH CARE AND NOT
REGULATED TO THE LITTLE
INSTRUMENT YOU THINK ABOUT ONCE
IN A WHILE.
>> WE HAVE TIME FOR ONE MORE
QUESTION.
IT WAS EASIER THAN I THOUGHT IT
WOULD BE.
>> THANK YOU.
I HAVE TOO MANY QUESTION TO ASK
BUT ONE IMPORTANT ONE.
WE HAVE A DEVICE AND I'LL GIVE A
PITCH OUT IN IN A FEW MINUTES SO
WE WON'T TALK ABOUT THAT BUT WE
HAVE THE ABILITY TO SEND DATA TO
DOCTORS AND PATIENTS AND IT'S
HARD TO KNOW HOW TO DO THAT SO
I'M INTERESTED IN YOUR VISION
FOR THE BEST WAY TO DO THAT?
THEY CAN E-MAIL EXCEPT THEY
DON'T ACCEPT E-MAIL AND DOCTORS
DON'T HAVE FAX MACHINES ANYMORE.
HOW CAN DATA FROM A TEST BE
REPORTED TO A DOCTOR?
>> I WISH I HAD MY LIFE LINE TO
THE THAT CAN ANSWER THE
INFORMATICS OF THIS AND IT COMES
DOWN TO WHAT MAKE MY TEST COUNT
HAS DONE.
IF THERE'S INNOVATION AROUND
TESTING TECHNOLOGY OR AN APP AND
THEY'RE LOOKING AT THE
BACKGROUND INFRASTRUCTURE OF HOW
DOES THAT DATA LITERALLY MOVE
FROM AN APP TO WHATEVER ENTITIES
THERE MAY BE TO FDA, CDC,
ETCETERA.
I KNOW IT'S NOT A SUPER
SATISFYING RESPONSE BUT IT'S
WHAT THE SHIELD PROGRAM IS
LOOKING AT ARE HL7 MESSAGING OR
FIRE.
WHAT ARE THE CODING PRACTICES
THAT NEED TO BE IN PLACE AND DO
THEY NEED TO BE CODED IN A WAY
THAT MAKES THEM STANDARDIZED AND
HARMONIZES THE DATA AND MAKES IT
INTEROPERABLE ACROSS DEVICES SO
BY THE TIME ET GETS TO MRNL
PUBLIC HEALTH AUTHORITIES IT CAN
BE PEARSED TO MAKE -- PARSED TO
MAKE THIS UNDERSTOOD AND
UNDERSTAND THE NITTY-GRITTY OF
HOW THE SHE'D PROGRAM IS DOING
THIS.
I DON'T HAVE THE DEEP KNOWLEDGE
TO EX PLIN ALL OF THAT.
I THINK THAT'S BROAD STROEKSZ
WHAT THE VISION IS IS WITH THAT
PRIME MINISTER
>> THE IDEA OF GETTING THE PACTS
INTO THE EMR IS A FORMIDABLE
CHALLENGE AND STARTS WITH WHO'S
EMR ARE YOU TRYING TO GET IT
INTO AND ARE YOU PART OF A
LARGER SYSTEM AND DO YOU WANT IT
PUSHED HERE OR THERE AND IT'S
BECOMING MESSY BECAUSE OF ALL
THE WAYS WE RECEIVE CARE.
WE ATTEMPTED TO INTEGRATE JUST
OUR HOME TEST TO TREAT PROGRAM
AND A FEW HOSPITAL SYSTEMS AND
IT WAS AN INTERESTING RESPONSE,
WE DON'T WANT YOU TO INTEGRATE
IN OUR HEALTH SYSTEM AND WE
ASKED FOR MORE INFORMATION.
ONE GROUP WAS SERIOUS ABOUT IT.
THEY ESSENTIALLY SAID WE DON'T
FEEL RIGHT GIVING ACCESS TO THE
SYSTEM AND IT'S ALMOST.
IT'S VERY DIFFICULT.
IT WILL BE AN EXTRAORDINARILY
BALANCE TO BE ABLE TO WRITE INTO
THE EMRs FROM DISTRIBUTED
SYSTEMS.
IT WILL TAKE A LOT.
>> THE GENERAL AREA OF
PATIENT-GENERATED HEALTH DATA IN
SOME WAYS COVID TEST RESULTS ARE
PRETTY SHORT AND PULSE OXIMETERS
AND GLUCOSE MONITORS AND DAILY
WEIGHTS FOR HEART PATIENTS AND
THE DATA A CONSUMER HAS ABOUT
THEIR HEALTH IS RISING.
THE STANDARDS EXIST AND THOSE
THINGS BUT I THINK IT'S THE LAST
INCH PROBLEM AND PRIORITIZING
THAT AND MAYBE A MEDICAL/LEGAL
AS WELL AS THE CONSERVATIVE VIEW
OF THE COUNCIL AND CAREGIVER IS
EVEN MORE INFORMATION FOR ME TO
BE RESPONSIBLE.
NOT ONLY DO I HAVE TO BE
RESPONSIBLE FOR CLINICAL CARE
WHEN I SEE YOU IN THE CLINIC OR
TELEHEALTH ENCOUNTER, YOU'RE
POTENTIALLY NOT FEELING WELL AT
HOME AND SENDING DATA TO ME.
HOW AM I SUPPOSED TO FIGURE THAT
OUT WITH A PANEL OF 2,000 OR
4,000 PATIENTS.
THOSE ARE THE STRUCTURAL THINGS
MAYBE NOT THE TECHNOLOGY.
WE KNOW IT WORKS GOING TO
HACKATHONS FOR YEARS NOW.
>> IT'S SOMETHING WE CARE A LOT
ABOUT AT NIBIB AND WORKING ON.
STAY TUNED JUST GIVE US A FEW
YEARS.
WE'RE OVER TIME.
LET'S THANKS OUR SPEAKERS ONE
MORE TIME.
I'LL HAND IT BACK TO TIFFANI.
>> THANK YOU, ANDREW.
SO WE ARE IN FOR A TREAT.
WE ARE NOW AT OUR KEY NOTE
SPEAKER TIME SO ANYTIME YOU KNOW
DR. TROMBERG COMES UP TO
INTRODUCE SOMEONE WE'RE
DEFINITELY IN FOR A TREAT.
HERE'S TO OUR KEY NOTE SPEAKER.
>> THANK YOU, TIFFANI.
WHEN YOU NEED A PROBLEM TO BE
SOLVED YOU NEED ARPA-H AND WE
HAVE THE DIRECTOR HERE RENE
WEGRZYN.
SHE'S THE FIRST DIRECTOR OF
ARPA-H APPOINTED BY PRESIDENT
BIDEN IN OCTOBER OF 2022.
JUST A LITTLE OVER ONE YEAR ON
THE JOB AND THE WORK SHE'S DONE
IN THAT SHORT PERIOD OF TIME IS
ASTOUNDING.
WE THINK RADX WENT FAST, OKAY,
THIS IS ANOTHER SCALE SO HOLD
ON, BUCKLE YOUR SEAT BELT FOR
HER TALK.
PRIOR TO THIS SHE WAS THE VICE
PRESIDENT OF BUSINESS
DEVELOPMENT AT GINKO BIO WORKS
AND THE HEAD OF INNOVATION AT
CONCENTRIC BY GINKO.
SOME MAY RECOGNIZE THAT.
WORKED ON BUILDING A NATIONWIDE
VIRAL GENOMIC SURVEILLANCE
NETWORK USING SYN BIO TOOLS AND
FOCUSSING ON AIRPORTS AND
SCHOOLS.
THIS PROGRAM WAS ALSO IN RADX
AND WE'RE PROUD TO STAY THE
SPINOFF WAS EXCITING REACHING
LOTS OF PEOPLE USING SYN BIO
TOOLS.
IT'S NOT SURPRISING.
RENEE CAME TO ARPA-H WITH OVER A
DECADE EXPERIENCE AT DARPA AS A
PROGRAM DIRECTOR AND TECHNOLOGY
CONSULTANT WHERE SHE SPECIAL I'D
IN LEVERAGING SYN BIO TOOLS AND
A PIONEER IN BIO DOMESTIC
ECONOMY EXPANSION AND TO THWART
BIO THREATS.
BEFORE JOINING DARPA SHE LED
TALES IN PRIVATE INDUSTRY ACROSS
A RANGE OF SPECIALTIES IN THE
AREAS WE TAUBT ABOUT.
-- TALKED ABOUT AND HER SHE WAS
A FELLOW AT HEALTH SECURITY AND
DID TRAINING IN GERMANY AND HAS
BEEN ON MANY GOVERNMENT AND
INDUSTRY ADVISORY BOARDS, HAS
WON A NUMBER OF AWARDS AND NOW
WE'RE INCREDIBLY LUCKY TO HAVE
HER AS THE FOUNDING DIRECTOR
ADDS ARPA-H.
LET'S WELL COME DR. WEGRZYN.
>> THANK YOU FOR BEING HERE AND
FOR THE INVITATION, BRUCE.
I REMEMBER MEETING YOU FOR THE
FIRST TIME EARLY IN THE PANDEMIC
AND THEY'RE LIKE YOU HAVE TO
TALK TO THIS GUY FROM NIH.
HE'S TRYING TO DO SOMETHING
INNOVATIVE IN TERMS OF TESTING.
EVERYONE WAS ON HIGH ALERT.
THIS IS THE BIGGEST BIOLOGICAL
EVENT OF OUR LIFE TIME AND I
HUNG UP AND I WAS LIKE, HUH, HE
SOUNDS LIKE HE'S FROM DARPA AND
IT WAS DISORIENTING BECAUSE IT
WAS A DIFFERENT APPROACH I'VE
EXPERIENCED FROM NIH AND
CONGRATS TO YOU AND YOUR TEAMS
AND THE WORK YOU DID DURING THE
PANDEMIC AND FOR THE WORK YOU'RE
DOING NOW.
ONE THING THAT KEEPS ME UP AT
NIGHT IS HOW FAR WE'VE COME AND
HOW QUICKLY WE BROUGHT
INNOVATION FORWARD THAT WOULD
HAVE TAKEN DECADES AND THE WORRY
OF THAT NOT BEING APPLIED IS
TERRIFYING AND THANK YOU FOR THE
CONSTANT COMMITMENT TO THAT.
YOU HEARD I LEFT HARPA AND WENT
TO THE PRIVATE SECTOR AND I
REALIZED GOVERNMENT DIDN'T HAVE
ALL THE ANSWERS AND PRIVATE
SECRETARY DIDN'T EITHER BUT
MAYBE WE CAN HAVE PARTNERSHIPS
THAT LOOK DIFFERENTLY.
THAT WROUGHT ME BACK TO
GOVERNMENT.
BROUGHT ME BACK TO GOVERNMENT
AND I TRIED TO STAND UP ARPA-H
AND LOOK AT DIFFERENT WAYS OF
MOVING FORWARD AND HAVING ARPA-H
FOR HEALTH AND THIS IS PRESIDENT
BIDEN'S MISSION IN MARCH OF
2022.
HE CALLED ON CONGRESS TO FUND
ARPA-H AND GO AFTER THESE BIG
IDEAS THAT MAY WORK BUT WE HAVE
TO TRY THEM FIRST AND HAVE A
SHOT ON GOAL TO SEE IF THE BIG
CRAZY IDEAS MAY WORK.
CONGRESS GRANT ED US AN
APPROPRIATION AND I GOT TO SET A
MISSION STATEMENT AND ACCELERATE
BETTER HEALTH OUTCOMES FOR
EVERYONE IS WHAT WE SETTLED ON.
WE KNOW WE'RE HERE TO ACCELERATE
THINGS.
THERE'S GREAT INNOVATION THAT
MAY GET THERE IN FIVE, 10, 15
YEARS BUT WE WANT TO GET IT
THERE FASTER.
WE WANT TO MEASURE OUR PROGRESS
AS AN AGENCY AND IMPACT ON LIVES
AND FOR EVERYONE.
MY BACKGROUND PRIOR WAS ON GENE
THERAPIES.
IF I SEE ANOTHER GENE THERAPY
THAT COMES OUTS SINGLE DOSE, $1
MILLION I REFUSE TO HAVE THAT
COME OUT OF ARPA-H NEED TO
DESIGN THEM AFFORDABLE TO THEY
CAN GET TO EVERYONE.
ONE OF THE MOST IMPORTANT THINGS
YOU SHOULD KNOW ABOUT ARPA-H IS
WE CAN DO WHAT WE DO IN HEALTH
LEGISLATIVELY WE HAVE THE POWER
TO MOVE FORWARD.
RADX HAS POWERS AS WELL AND IN
AN ASPIRING WAY.
WE DON'T HAVE ANY INTRAMURAL
LABS.
OUR STRUCTURE IS INTERESTING.
I LIKE TO THINK THIS IS BEING
INCUBATED BY NIH BUT WE'RE
INDEPENDENT AGENCY AND NOT AN
INSTITUTE.
I REPORT TO SECRETARY BECERRA
AND THAT ALLOWS US TO HAVE A
SEPARATE AGENDA.
OUR APPROPRIATION IS SEPARATE
FROM NIH BUT ARE ABLE TO LEAN ON
EXPERTS FROM YOUR SELVES THAT
HELP STAND UP OUR RESEARCH AND
MAKE SURE WE'RE NOT BEING
REDUNDANT WITH THE OTHER
FANTASTIC WORK IN THE
INSTITUTES.
COOPERATIVE AGREEMENTS AND OTHER
TRANSACTIONS IS THE WAY WE WANT
TO DO BUSINESS BECAUSE WE'RE
FOCUSSED ON SOLVING BIG PROBLEMS
IN HEALTH AND HAVE PROGRAM
MANGERS TO SOLVE THEM IN A
BOTTOM'S UP WAY AND TALK ABOUT
THE WAYS ARPA-H IS INVESTING IN
A COUPLE SLIDES BUT KNOW WE HIRE
PROGRAM MANAGERS FOR TERM
APPOINTMENT OF THREE YEARS.
THEY COME IN AND THEY'RE GREAT
DOERS BUT WE DON'T HIRE THEM
BECAUSE OF THEIR FANTASTIC
RESUMES, WE HIRE THEM BECAUSE OF
THE PROB IN HEALTH THEY WANT TO
SOLVE AND THEY'RE COMMITTED TO
COME FOR THREE YEARS TO THE
FEDERAL GOVERNMENT AND WE GIVE
THEM THE RESOURCES TO SPRINT.
EVERY TWO WEEKS THAT GOES BY 1%
OF THEIR TIME IS UP SO THERE'S
URGENCY IN MOVING FORWARD.
AND WE CAN OFFER A COMPETITIVE
SALARY.
THIS IS INCENTIVE.
WE KNOW WE'RE NOT OFFERING A
FOREVER JOB SO BY TAKING ON THE
TERM LIMIT WE WANT TO GIVE YOU
SOME OF THAT FLEXIBILITY.
WE'RE HERE TO INVEST IN THINGS
THAT INDUSTRY WON'T SUPPORT
BECAUSE THEY'RE TOO RISKY.
WE'RE HERE TO INVEST IN PROJECTS
THAT NIH CAN'T SUPPORT AND
INVEST IN THEM AND SHOW THEY'RE
POSSIBLE AND HAND THEM OFF AND
NIH MAY HELP WITH A PROJECT DOWN
STREAM AND WOULD LOVE A
COLLABORATION AND OTHERS WE THE
NEED TO BE THERE FROM DAY ONE SO
WHEN WE GET TO THE END OF THE
PROGRAM IT CAN BE REIMBURSED AND
CAN BE REGULATED.
AND OF COURSE PRIVATE INVESTORS
AND NGOs AND TALK ABOUT THE
COMPONENTS OF THE ECO SYSTEM.
NOT A SINGLE DOLLAR AT ARPA-H IS
LINKED TO A SPECIFIC DISEASE OR
SPECIFIC TECHNOLOGY.
WE'RE LOOKING FOR PROJECTS
INVESTMENT CAN LEAD TO AN
ASYMMETRICAL ADVANCEMENT TO THE
STATE OF THE ART OR HEALTH
OUTCOMES WE'RE LOOKING TO
ACHIEVE.
I WANT TO PITCH THIS ROOM ON OUR
PROGRAM MANAGER.
WE SAY THEY ACT AND THINK LIKE
CEOs BECAUSE THEY BRING THE
PROBLEM TO SOLVE AND ARE NOT
AFRAID TO FAIL, THEY'RE NOT
AFRAID TO TRI BIG THINGS BUT
ALSO TECHNICALLY HONEST AND
MANAGE THEIR PORTFOLIO AND
RESOURCES.
IF SOMETHING'S NOT WORKING THEY
CAN PIVOT THOSE ELSEWHERE AND
WHERE THE NON ISSUING GRANTS
BECOMES IMPORTANT.
WE HAVE MILESTONE BASED
CONTRACTS AND ALSO HAVE THOSE
OTHER TRANSACTIONS TO HELP
FACILITATE THAT.
THESE ARE SOME OF OUR PROGRAM
MANGERS.
WE HAVE 17 TO DATE AND WE HAVE A
DIVERSITY ISSUE.
S.T.E.M. IS NOT VERY DIVERSE TO
START AND SO WE WOULD LOVE A
POOL OF APPLICANTS THAT
REPRESENTS THE AMERICANS THAT
WE'RE HERE TO SERVE AND SO IF
YOU ARE A CANDIDATE OR KNOW OF A
CANDIDATE THAT MAY BE INTERESTED
IN BECOME PROGRAM MANAGER IT'S
SIMPLE.
CONTACT OUT AND WE'LL ASK TO YOU
PITCH HEILMEYER QUESTION AND
WE'LL WALK THROUGH WHAT THAT
LOOKS LIKE.
THE POWER OF AN ARPA-H IS THE
RESOURCES WE GIVE TO THESE
PROGRAMS BETWEEN $50 TO $150
MILLION FOR A PROGRAM AND WE CAN
BRING FDA, CMS, HHS AND OTHERS
AND NIH TO THE TABLE TO MAKE
SURE YOU HAVE EVERYBODY YOU NEED
TO SOLVE YOUR PROBLEM THERE TO
SUPPORT YOU.
THIS CREATES A FLY WHEEL.
AS WE HIRE THE 17 PROGRAM
MANAGERS THEY'LL LAUNCH THE
PROGRAM AND BE HERE FOR YEARS
AND SIX IS THE MAXIMUM TIME
FRAME AND LAUNCH A VARIETY OF
PROGRAMS AND LEAVE THE AGENCY.
WHEN YOU LOOK AT THE PORTFOLIO
WHAT WE'RE INVESTING IN IS A
REFLECTION OF THE PROGRAM
MANAGERS AND THEIR INTERESTS,
WHAT DRIVES THEM AND FIVE YEARS
FROM NOW SHOULD LOOK COMPLETELY
DIFFERENT BECAUSE YOU WOULD HAVE
CYCLED IN NEW PROGRAM MANAGERS
AND THOSE ARE THE SOLUTIONS WE
CAN BRING FORWARD.
QUITE A DIFFERENT MODEL FOR THE
FEDERAL GOVERNMENT.
AND THESE IS HOW WE TALK ABOUT
THE PROBLEMS.
NO JARGON, WHAT'S THE HEALTH
PROBLEM YOU'RE TRYING TO SOLVE
AND HAZE IT DONE TODAY AND
WHAT'S YOUR INSIGHT AND GAME
CHANGING THING YOU WANT TO DO
YOU THINK IS GOING TO BE
SUCCESSFUL TO SOLVE THIS
PROBLEM?
SOMETIMES IT'S A PHYSICS
APPROACH AND HAVE A SYSTEMS
INTEGRATION FOR MATURE PRODUCTS
WE CAN COLLECT DATA ACROSS THE
UNITED STATES FOR TESTING FOR
EXAMPLE EITHER OF THOSE WOULD BE
VALID HERE.
IF WE SUCCEED WHO IS GOING TO BE
IMPACTED?
WE WANT THAT QUANTITATIVE?
WHAT WILL THE HEALTH OUTCOMES?
IT COULD BE A SMALL GROUP AND
PURSUE RARE DISEASES BUT WANT TO
BE CLEAR WHERE WE THINK THE
IMPACT WILL BE AND WHAT INTEREST
THE RISKS TO MITIGATE ALONG THE
WAY AND HOW LONG WILL IT TAKE
AND HOW MUCH WILL IT COST AND IF
WE ARE GOING FOR THE NEXT
MOONSHOT IN HEALTH WE NODE --
NEED TO KNOW HOUR MILESTONES AND
WHAT DOES THAT LOOK LIKE TODAY
TO KNOW WE'RE MAKING PROGRESS.
ONE FAVORITE EXAMPLE IS STEALTH
TECHNOLOGY FURTHER DEVELOPED BY
THE AIR FORCE.
PEOPLE MAY NOT KNOW WHAT THE
PROGRAM LOOKED LIKE A $30
MILLION PROGRAM TO FUND TWO
AIRCRAFT.
THE WAY IT ENDED WAS WITH THE
TWO AIRCRAFT CRASHING.
THEY HAD MATERIALS STEALTHY ON
THE OUTSIDE AND IT MAY HAVE
LOOKED LIKE A FAILURE AT FACE
FAILURE AND WHEN YOU LOOKED AT
THE DATA IT WAS UNDETECTABLE
UNTIL IT CRASHED AND THAT'S WHAT
THE AIR FORCE PICKED UP AND SOME
PROJECTS MAY LOOK LIKE THAT.
WHAT DO WE NEED TO PROVE TO GET
THE OF THE ECO SYSTEM TO PICK
THIS UP.
WE ADDED OTHER QUESTIONS BEYOND
WHAT DARPA TYPICALLY ASKS FOR.
AS WE DESIGN THE PROGRAMS WE
LOOK AT COST AND SUPPLY CHAIN
AND ACCESSIBILITY AND THEN
IMPORTANTLY USER EXPERIENCE.
THIS GROUP KNOWS A LOT OF ABOUT
CUSTOMER EXPERIENCE AND USER
EXPERIENCE.
IT'S NOT TYPICALLY PART OF THE
FEDERAL R&D PROGRAMMING.
WE WANT TO MAKE SURE THAT WE ARE
IB AN ITERATIVE WAY INVESTING
THE PUBLIC AND HEALTH CARE
PROVIDERS AND TRANSITION THEM
OUT OF THE AGENCY.
AND LAST BUT NOT LEAST THINKING
HOW A PROGRAM MAY BE
MISPERCEIVED.
I HAPPEN TO HAVE BEEN AT DARPA
WHEN WE FUNDED MODERNA.
I WISH WE STARTED A DECADE AGO
AROUND VACCINE ADOPTION AND
UNDERSTANDING WHAT THE
TECHNOLOGIES LOOK LIKE AND WHAT
IS THAT USER EXPERIENCE?
THERE'S LESSONS LEARNED WE WANT
TO APPLY.
THE TYPICAL PROGRAM LIFE CYCLE
TYPICALLY LOOKS LIKE THIS.
WE BRING IN A PROGRAM MANAGER
AND THE PROBLEM THEY WANT TO
SOLVE AND LAUNCH THAT EFFORT AND
ANNOUNCE IT THROUGH SOLICITATION
AND LOOK FOR SOLVERS.
TEAMS OF PEOPLE OR ACADEMICS OR
SMALL COMPANIES AND ABE PROGRAM
MANAGER WILL SELECT THE GROUPS
TO GET FUNDED AND THIS IS
DIFFERENCE FROM OTHER FUNDERS IN
THAT THE PROGRAM MANAGER IS THE
SOLE DECISION MAKER ON WHO GETS
FUNDED BY THAT PROJECT.
WE WELL BRING IN OTHER EXPERTS
BUT THE PROGRAM MANAGER MAKES
THE DECISION TO TAKE THE RISKS
GOING FORWARD.
IT ALLOWS US TO MOVE QUICKLY AS
WE START A PORTFOLIO OF
SOLUTIONS TO A GIVEN PROBLEM.
AND THE PERFORMERS HAVE A SEAT
AT THE TABLE AND WILL LOOK AT
MILESTONES AND PROGRESS LAID OUT
CLEARLY IN THE SOLICITATION AND
NOT EVERY TEAM MAKES IT THROUGH
EACH STAGE.
THE GOAL IS TO SOLVE THE PROBLEM
AND MAYBE THAT'S ONE OR TWO ON
THE BACK END.
AND GENICA PATTERSON WAS AT RADX
AND DARPA AND NOW WITH US AND
HAS A DEEP UNDERSTANDING OF
TRANSITION IN THE AGENCY AND IT
GOES BEFORE WE LAUNCH A PROGRAM
TO DO A MARKET TO UNDERSTAND THE
MARKETPLACE THAT WE'RE GOING
INTO.
A VERY UNIQUE PART OF WHAT WE'RE
DOING AT ARPA-H.
WE INTERACT WITH OUR PERFORMERS
AND NIH EVERYTHING FROM THE
DESIGN PARAMETERS TO EXECUTING
AND GET INSIGHT AND
COMMERCIALIZE.
I DID SAY ARPA-H IS A BOTTOMS UP
ORGANIZATION AND WALKING IN THE
DOOR I HAD TO MAKE CLEAR WHAT
ARE MY FOCUS AREAS I THINK
INVESTMENT FROM ARPA-H CAN HAVE
BENEFIT TO THE HEALTH ECO
SYSTEM.
FIRST IS HEALTH SCIENCE
FEATURES.
THINKING ABOUT THE TOOLS,
TECHNOLOGIES AND PLATFORMS OF
THE FUTURE THAT MAY NOT EXIST
TODAY, MAYBE 10 YEARS AGO IT
WOULD HAVE BEEN MRNA PLATFORMS
BUT WANT TO STIMULATE THE NEXT
SERIES OF INNOVATIONS.
THERE'S A WHOLE OFFICE DEDICATED
TO THAT AND A TEAM PROGRAM
MANAGER IS FOCUSSED UNDER THAT
UMBRELLA ON THE SPECIFIC
PROBLEMS THAT ALIGN.
SCALABLE SOLUTIONS.
THE CHALLENGE OF SCALE IS NOT
JUST THE SCALE OF MANUFACTURING
BUT GETTING TO EVERY PERSON
WHEREVER THEY MAY BE IF IT'S AN
AMERICAN RESERVATION TO URBAN
CENTERS.
THEY ALL REPRESENTATIVE
DIFFERENT CHALLENGES YOU WANT TO
ADDRESS.
PROACTIVE HEALTH.
KEEPING PEOPLE INTEREST BECOMING
PATIENTS, DETECTION, DIAGNOSTICS
AND MENTAL HEALTH INTERVENTIONS
WHICH FALL UNDER THE CATEGORY
AND RESILIENT SYSTEMS WAS
INSPIRED DURING MY TIME DURING
THE PANDEMIC AND WHAT DO ARPA-H
HAVE TO INVEST IN TODAY WHEN
WE'RE NOT IN AN EMERGENCY OR
CRISIS SITUATION TO PUT IN PLACE
FOR THE NEXT CRISIS.
WHAT YOU'VE BEEN DISCUSSING
ALIGN TO THIS AND SYSTEMS
INTEGRATION TO CREATE NEW DATA
SYSTEMS.
AS WE FUND PROGRAMS AT ARPA-H
YOU MAY HEAR PROGRAMS OR
PROJECT.
PROGRAMS ARE DERIVED FROM THE
PROGRAM MANAGERS AND PROJECTS
COME FROM YOU.
WE'RE LOOKING FOR FOLKS FROM
OUTSIDE OF ARPA-H TO SUBMIT
IDEAS TO OUR AGENCY ANNOUNCEMENT
AND SOLICITATION AND
THREE-PAGERS.
DON'T SPEND A LOT OF TIME AND WE
DON'T WANT TO SPEND A LOT OF
TIME UNLESS WE'RE INTERESTED AND
IF THERE'S SOMETHING WE'RE
EXCITED ABOUT WE CAN INVITE A
FULL PROPOSAL AND START FUNDING
THOSE.
I'LL WALK YOU THROUGH A FEW
THINGS IN OUR FIRST YEAR OF
EXISTENCE WE STARTED FUNDING
FROM THE PROGRAM AND PROJECT
SIDE.
AND NOVEL INTERVENTIONS FOR
OSTEOARTHRITIS FROM A SURGEON
WHO SAID IN A GOOD CAREER THEY
CAN DO 3 OR 4,000 KNEE
REPLACEMENT.
I WANT TO MAKE AN IMPACT AND
THAT'S NOT ENOUGH.
WHAT CAN I DO TO MAKE AN IMPACT
ON THIS FOR THOUSANDS OF
PATIENTS AND HE SAID I CAN
REVERSE IT.
ARPA-H IS WHERE WE WANTS TO THEY
CAN THE SHOT ON GOAL AND LOOKING
AT CARTILAGE AND BONE
REGENERATION AND COMPLETE JOINT
REPLACEMENTS IN A LAB FOR
TRANSPLANTATION.
THEY REPRESENT THE DEMOGRAPHICS
OF THE DISEASE AND THIS IS AN
EXAMPLE OF A PROGRAM.
AND TWO OF LIVE SOLICITATIONS
THAT WE HAVE RIGHT NOW THAT IF
YOU'RE INTERESTED IN APPLYING TO
YOU CAN GO TO OUR WEBSITE AND
LEARN ABOUT REACT WHICH IS
RESILIENT EXTENDED AND AUTOMATED
CELLULAR THERAPIES.
BIO ELECTRONIC DEVICES THAN CAN
RESULT IN A CLOSED LOOP SYSTEM
TO SENSE WITH CELLS WHAT IS
HAPPENING AND HAVE A RESPONSE
DEVICE.
A LOT OF FAILURES AND PATIENT
TREATMENT RIGHT NOW ARE PATIENTS
THAT FAIL TO ADHERE TO THEIR
MEDICAL REGIMENT AND THIS WOULD
BE TO HELP ADDRESS THAT IN SOME
WAYS.
AND APAX.
WHAT IF WE CAN ELIMINATE VIRUSES
AS A CURRENT AND FUTURE HEALTH
THREAT.
THIS IS AIMED AT ACCELERATING
THE FOCUS FROM OUR MISSION
STATEMENT ON THE ACCELERATION
SOME OF THE MI TECHNOLOGIES AND
ANTIGENS TO KNOCK OUT ENTIRE
FAMILIES OF VIRUSES SO WE DON'T
HAVE TO HAVE BOOSTERS OR COUNTER
MEASURES EVERY TIME THERE'S A
NEW THREAT.
AND PROJECT FROM THE OPEN V.A.
WORTH HIGHLIGHTING THE
INNOVATIONS WE'RE PURSUING ONLY
ARPA-H CAN BECAUSE THEY ONLY
REPRESENT HIGH RISK AND A SYSTEM
THAT TARGETS TRANSCRIPTIONAL
ACTORS AND SYSTEMS TUNE UP OR
DOWN THE IMMUNE SYSTEM AND WE'RE
USING THIS FOR THREE
INDICATIONS.
FOR LONG COVID FOR AUTO IMMUNE
DISORDER LUPUS AND FOR CANCER.
THIS IS FROM THE HEALTH SCIENCE
FUTURES OFFICE.
WE'RE NOT FOCUSSED ON ONE
SPECIFIC DISEASE BUT WANT TO
RISE ALL SHIPS FOR A NEW
PLATFORM WE MIGHT BE ABLE TO
TUNE IN IN THIS CASE LOOKING AT
WAYS TO PRINT AND REGENERATE
HEART TISSUE LOOKING AT
REGENERATION AS WELL AS WHAT IF
WE CAN IDENTIFY ANTIBIOTIC
RESISTANT MATERIAL IN MINUTES.
THIS HAS BEEN OUT FOR A LONG
TIME BUT LOOKING AT DEVICES THAT
CAN BE USED AT THE BENCH SIDE
YOU CAN TRULY GET THE DIAGNOSIS
IN MINUTES AND GET ON THE RIGHT
ANTIBODY REGIMENT.
-- ANTIBIOTIC REGIMENT AND WE
WERE ANNOUNCED IN THE SAME
BREATH WITH CANCER MOONSHOT AND
WE'RE HERE TO LAUNCH MOONSHOTS
ACROSS THE BOARD FOR HEALTH
HOWEVER, WE HAVE MADE
INVESTMENTS THAT WILL ADVANCE
THE OBJECTIVES OF CANCER MOON
SHOT INCLUDING THESE MENTIONED
HERE.
I'LL HIGHLIGHT TWO OF THEM.
ONE IS AROUND PROGRAMMABLE
BACTERIA THAT CAN BE DIRECTED TO
KILL CANCER INSIDE THE BODY.
THERE'S BEEN FUNDAMENTAL
RESEARCH IN THIS AREA BUT WANT
TO MAKE THE TRANSLATIONAL TO
BRING THIS FORWARD TO THE CLINIC
AND OUR PRECISION SURGICAL
INTERVENTIONS PROGRAM.
IMAGINE BEING IN THE OPERATING
ROOM WHERE IN THE O.R. THE
SURGEON THE ABILITY TO LOOK IN A
SURGICAL CAVITY AND SEE THE
MARGINS AND IN REAL TIME BE ABLE
TO KNOW DID I REALLY CUT ALL
THIS OUT RATHER THAN SENDING
SOMETHING DOWN THE HALL TO THE
PATHOLOGIST AND INNOVATIONS IN
THE OPTICAL IMAGERY THAT WILL BE
DONE AND THE REAGENTS FOR
IMAGING AND THE ROBOTIC SURGERY
CAPABILITY ARE CORE PIECES AS
WELL AS SENDING DATA PACKET.
ONE OF THE PRESSURE TESTS IS TO
DEMONSTRATE SUCCESSFUL SURGERIES
IN LIVE SETTINGS.
WE WANT TO USE ARPA-H AS A WAY
TO EQUALIZE THE CAPABILITIES.
SO LAST BUT NOT LEAST I WANT TO
INTRODUCE A CONCEPT THE ARPA-H
NET.
MAY HAVE HEARD THE TERM THE ARPA
NET.
THE NOD TO WHAT WE'RE ASPIRING
TO BUILD IS ARPA-H.
IT'S A SASSY WAY OF RESPONDING
TO SOME OF OUR LEGISLATION WHERE
THE CONGRESS TOLD US WE HAVE
THREE GEOGRAPHIC SITES BUT ONLY
210 EMPLOYEES.
IMAGINE AN AGENCY TASKED TO DO
THESE THINGS AND SPREAD YOURSELF
ACROSS THREE SIGHT AND WE TOOK
ON THE CHALLENGE AND WHERE HE
RAISED THE CONGRESS THE AR PA
NET HEING REACH PEOPLE WHERE
THEY ARE THROUGH A HUB AND SPOKE
NETWORK.
IF WE TAKE HE THREE SITES ONE IN
THE THASHL REGION AND THE MAIN
OFFICE IN WASHINGTON, D.C.,
WHERE WE ARE CLOSE TO OUR
STAKEHOLDERS, NIH, CMS, FDA BUT
WE LAUNCHED A MATION WIDE
COMPETITION FOR A HUB.
AND WE'RE MOVING QUICKLY.
WE CAN'T ENROLL ONE PATIENT A
MONTH WE NEED TO MOVE QUICKLY
AND USE THE SCALE OF PUSHING NEW
WAYS ACROSS THE ECO SYSTEM.
AND WHENEVER THAT COMPETITION
WAS DALLAS, TFLS.
WE HAVE AN OFFICE IN DALLAS AND
THEY ENGAGE EIGHT 50-STATE
NETWORK TO HELP US DO THIS HUMAN
CENTERED DESIGN PART OF OUR
PROGRAMS AND RECENTLY ANNOUNCED
OUR HUB IN CAMBRIDGE,
MASSACHUSETTS.
WE NEED TO GET IT OUT IN THE ECO
SYSTEM AND GET OUR INVESTOR BASE
TODAY AND UNDERSTAND WHAT WE
NEED TO DERISK TO PICK IT UP ON
THE BACK END.
YOU MAY HAVE RECOGNIZED THE
INVENTOR WELL SO VENTURE WELL
COMPETED AND WAS SUCCESSFUL IN
THIS AWARD TO LEAD THIS INVESTOR
CATALYST FOR THE ENTIRE NATION.
SOME WILL SOUND FAMILIAR TO RADX
AND BE A CONVENER AND WANT OPEN
DIALOGUE AND WANT ALL OUR
PROGRAMMERS AND PROGRAM MANAGERS
TO USE THE ARPA NET AND THEY
HAVE NO IDEA HOW TO SCALE TO A
BILLION DEVICES AND WE HAVE
ENROLLED A LOT OF ADVANCED
MANUFACTURING CAPABILITY IN OUR
HUB AND SPOKE NETWORK FOR OUR
PORLERS SAY WE WANT TO NEGOTIATE
FROM THE GOVERNMENT PERSPECTIVE
A BEST USE OF POINTS FOR THE
GOVERNMENT AGREEMENT WITH YOU
BECAUSE WE WANT TO HELP BRIDGE
THE START-UP INTO THE REAL
WORLD.
THIS ONE $OF A WAY TO HELP HERE
AN GOING THIS THROUGH THE OTHER
TRANSACTION MASTER VEHICLE TO DO
IT QUICKLY.
HAVING THIS ALL IN PLACE BEFORE
THE CRISIS IS VERY IMPORTANT AND
TWO YEARS DOWN THE LINE WE MAY
HAVE MISSED SOMEBODY THAT SHOULD
HAVE BEEN PART OF THE PROGRAM WE
CAN RECRUIT THEM THROUGH THE
ARPA NET.
I HOPE YOU MAY CONSIDER TO BE A
SPOKE AS WELL.
THESE ARE A FEW OF EXAMPLES, FOR
EXAMPLE CHEROKEE NATION OR
UNIVERSITY AND MAYO CLINIC AND
MANY OTHERS.
THIS IS AN EASY WAY TO STAY
INVOLVED WITH ARPA-H AND IT WILL
BE A TOOL TO HELP RECRUIT.
THEN I THINK THIS IS MY SECOND
TO LAST SLIDE.
I WANT TO SHARE A CALL FOR
SOMETHING ELSE THAT MAY BE
RELEVANT TO THIS GROUP, OUR
ADVANCING CLINICAL TRIAL
READINESS INITIATIVE.
WE BELIEVE THAT 90% OF ALL
AMERICANS SHOULD BE ABLE TO GET
ACCESS TO A CLINICAL TRIAL
WITHIN 30 MINUTES OF THEIR HOME.
WE'RE LOOKING FOR SOLVERS TO
HELP CLOSE THAT GAP SO WE'RE
ABLE TO DO THAT.
THE QR CODE WILL SEND YOU THERE
AND IMPORTANTLY A FOOL FOR ALL
OF OUR PROGRAM MANAGERS.
IF YOU WANT TO PROGRAM AN OST
OSTEOARTHRITIS OR LAUNCH IN A
COVID AND HAVE IT BELIEVE BEHIND
INFRASTRUCTURE NIH AND HHS THAT
WOULD ALSO BE WELCOME TO USE.
I HOPE I PIQUED YOUR INTEREST
AND BECOMING A SPOKE IN OUR
NETWORK OR IF YOU DON'T KNOW BUT
MAYBE ARE INTERESTED IN KEEPING
UP TO DATE WE HAVE A NEWSLETTER
EVERY TWO WEEKS TO LET YOU KNOW
ABOUT YOUR PROGRAM ANNOUNCEMENTS
AND KNEW HIRES OR SOMETHING
INTERESTING TO HIGHLIGHT THE
WORK DONE AND ONE OF THE BESTEST
WAYS IS TO COME ON BOARD AS A
PROGRAM MANAGER AND WE'LL GIVE
YOU A DECENT SIZED BANK ACCOUNT
IN YOUR PORTFOLIO TO INVEST IN
THE STATE OF THE ART.
IF YOU'VE BEEN TO THE GALLERY
OUTSIDE THE WHITE HOUSE THERE'S
A FANTASTIC SCULPTURE THAT
REMINDS ME HOW MUCH YOU'VE
ACHIEVED AND HOW MUCH THE TEAM
AT ARPA-H HAS AND HOPEFULLY WE
KEEP LOOKING AT THIS AND
ADVANCING THE SATE OF THE ART.
THANK YOU.
I THINK I HAVE TIME FOR
QUESTIONS IF SOMEBODY WOULD LIKE
MORE INFORMATION.
>> CONGRATULATIONS ON YOUR
PROGRAM AND VISION HOW ARE YOU
GOING TO ENSURE THERE'S A
DIVERSITY AND INCLUSION CAN
INCLUSIVENESS IN YOUR PROGRAM?
I DIDN'T HEAR THAT ADDRESSED IN
YOUR PRESENTATION.
>> IT'S A GREAT QUESTION AND
DRIVING FORCE IN WHAT WE WANT TO
DO AT ARPA-H.
THERE'S A FEW RESPONSES TO THAT.
ALWAYS LOOKING TO IMPROVE, OF
COURSE.
ONE IS IN THE HEILMEIER QUESTION
NINE WHICH IS HOW ARE YOU
ADDRESSING COST AND
ACCESSIBILITY AND USER
EXPERIENCE.
WE WON'T PROVIDE ABE INVESTMENT
FUNDS TO PROGRAM MANAGER UNLESS
THEY HAVE A NEW PROGRAM THE
FIRST TIME IT DOES NOT HAVE A
CLINICAL TRIAL THAT REPRESENT
THE DEMOGRAPHICS OF THAT DISEASE
WITH NATIVE AMERICAN AND NATIVE
ALASKAN AND BLACK AND BROWN.
IT'S HARD TO MATCH THE
DEMOGRAPHICS BUT IT'S A
REQUIREMENT TO RECEIVE OUR
FUNDS.
EACH TEAM HAS TO BRING ON BOARD
A HEALTH EQUITY OFFICER AND WILL
NOT GET THE FUNDING WITHOUT THE
CLINICAL TRIAL DIVERSITY
REPRESENTED.
WE ARE TRYING TO USE OUR HOLE AS
FUNDER TO LEVERAGE -- OUR ROLE
AS FUNDER TO LEVERAGE THAT.
WE'VE DONE A BIT OF ENGAGEMENT
FIRST WITH HBCUs AND LAUNCHED AT
HOWARD UNIVERSITY WE'RE NOT
GETTING A LOT OF APPLICATIONS
FROM MINORITY-SERVING
INSTITUTIONS.
WE HAD QUITE A BIT OF ALUM A --
ALUMNI AND WE WENT TO MOREHOUSE
COLLEGE AND SPELLMAN THEY SAID
THE SIZE OF THE AWARDS TO LAUNCH
I MENTIONED $150 MILLION FOR
PROGRAM EXCEEDS THEIR BUDGET FOR
A FULL DEPARTMENT FOR A GIVEN
YEAR AND DON'T HAVE THE
GRANT-WRITING CAPABILITIES TO
COMPETE WITH AN M.I.T. OR
HARVARD OR ANOTHER GROUP THAT
DOES THIS FOR A LIVING.
WE TOOK THAT INTO ARCH WHEN WE
LAUNCHED ARPA-H AND THEY SHOULD
BE SIMPLE APPLICATIONS THAT
DIDN'T REQUIRE SPECIALIZED GRANT
RIGHTING CAPABILITIES AND WE'RE
TREG TO LOWER THE BARRIERS FOR
ENTRY FOR THE OTHER FOLKS AND
WONDER ANY SUGGESTIONS FOR
PROGRAM MENK AND STAFF AS WELL.
WE HAVEN'T HAD EIGHT OF
APPLICANTS THAT COME FROM
DIVERSE POPULATIONS.
WE WOULD LOVE TO SEE A GREATER
INFLUX.
WE HAD A TRIPLE ISSS FELLOW
FOCUSSED ON HELPING OUR AGENCY
BRIDGE THAT GAP WE'VE ONLY BEEN
AROUND A YEAR AND WANT TO LAY
DOWN THE GROUND WORK.
>> EXPLAIN THE SPOKE PROGRAM.
>> SO WE HAVE PREREGISTERED
TEAMS THAT ARE SPOKES AND CAN BE
HOSPITAL TO A SMALL COMPANY OR
COMMUNITY HEALTH CARE CENTER
THAT WANTS TO STAY CONNECTED TO
ARPA-H.
THERE'S NO PAY TO PLAY MODEL BUT
THEY HAVE BEEN PREAPPROVED TON
PART OF THE SYSTEM.
WITH AFTER, WE LAUNCHED THIS
CLINICAL TRIAL NETWORK AND
TRYING TO ENGAGE TEAM TO
PARTICIPATE CONSENT AT SCALE.
WE'LL ANNOUNCE IT TO THE NETWORK
AND PEOPLE CAN JOIN TO
PARTICIPATE.
WE WANT TO USE THE POWER OF THE
NETWORK TO CONTINUE TO GROW IT.
SAY WE ENROLL THE CLINICAL TRIAL
FOR NYTRO.
WE MAY ENROLL 10 SPOKES TO BE
THE CLINICAL TRIALS CENTERS BUT
ONCE WE ESTABLISH THE
RELATIONSHIPS WHEN NITROPROGRAM
GOES AWAY WE'LL STILL BE
CONNECTED WITH THE CENTERS SO
THAT THERE'S AN EASIER BARRIER
TO ENTRY FOR THE NEXT CLINICAL
TRIAL.
IT'S A BIG EXPERIMENT FOR US.
WE'VE AGREED TO FUND IT FOR FIVE
YEARS AND WANTED TO SEE WHAT WE
CAN DO TO GET HHS TO DO THIS
LONGER TERM.
AND NOT HAVING PREEXISTING
RELATIONSHIPS WITH MANUFACTURERS
THAT THEY WOULD BE AT A
DISADVANTAGE TO APPLY FOR
PROPOSAL AND IF WE USE THE
ARPA-H NET YOU MAY HAVE THE
DEPOSIT NEGOTIATE WITH RECESS
AND CONNECT THEM MAYBE IT'S A
SMALL UNIVERSITY, MAYBE IT'S A
SMALL COMPANY THAT ONLY HAS THE
PEOPLE.
TRYING TO BE AN EQUALER IN THE
PAY WE FUND THINGS ARE OUR GOAL.
AND I SAID THE THE GOAL OVER THE
NEXT YEAR TO DO SEVERAL TYPE OF
ACTIVATION TO SHOW THE POWER OF
THE COMMUNITY.
MAYBE WE'LL HAVE MANUFACTURING
CHALLENGES, MAYBE WE'LL HAVE
DATA CHALLENGES OR CLINICAL
TRIALS CHALLENGE TO TRY TO FLEX
THE NETWORK AND SEE HOW TO USE
IT BEST FOR THE AGENCY.
THANK YOU VERY MUCH FOR YOUR
WORK.
>> THANK YOU SO MUCH.
WE'RE DUE FOR A BREAK RIGHT NOW.
WE WILL BREAK FOR 15 MINUTES SO
I ASK THAT YOU GUYS BE BACK AT 3:45, PLEASE.
WE'RE GOING TO GET STARTED AND
HIRING IN THE POINT OF CARE
HEALTH AND TECHNOLOGIES AND
INTERESTED AND HAVE A DEGREE IN
BIO ENGINEERING AND HAVE
INTERESTS IN POINT OF CARE
TECHNOLOGY AND DIGITAL HEALTH
WE'RE LOOKING TO APPLY IN AI
POSITION AS PROGRAM OFFICER WITH
THE NIH AND NIBIB.
THANK YOU.
SO WE ARE GOING TO MOVE RIGHT
INTO OUR RAPID PITCH SESSION FOR
OUR SECOND DAY OF THE EXHIBIT.
AND DR. DIVI WILL INTRODUCE THE
TECHNOLOGY SHOWCASE
>> THANK YOU, TIFFANI.
WE HAVE TEN TECHNOLOGIES.
THE FIRST IS SPEAKER IS JEFFERY
AND HE'LL TALK ABOUT SIMPLIFIED
INTEGRATED PLATFORM.
I'M JEFFERY.
I'M A CEO.
I'M FRANK A DIRECTOR.
SIMPLIFIED EX IS A PLATFORM THAT
IS A COLLABORATION.
THE PLATFORM IS OUR VISION FOR
THE PLATFORM IS TO BRING POINT
OF CARE PERFORMANCE AND SEAMLESS
DIGITAL TEST REPORTING TO AN
AT-HOME SETTING AND MAKE IT INTO
A HIGHLY ACCESSIBLE PLATFORM FOR
UNDER FIVE DOLLARS COST OF
GOODS.
OUR VISION IS TO TRANSFORM THE
WAY WE APPROACH HEALTH CARE
TODAY.
THIS IS WHAT WE DEVELOPED WE
SPECIALIZE IN THE RAPID
DIAGNOSTIC LATERAL FLOW TEST
KITS AND OFFER TESTS FROM
INFECTIOUS DISEASE TO CARDIAC
TUMOR MARKERS BUT SINCE COVID
AND WITH THAT IN OPENING UP OF
THE OTC TEST MARKET WE HAVE COME
TO REALIZE MOST THE TEST TODAY
ISN'T THAT FRIENDLY TO THE OTC
CONSUMERS.
TAKE THE COMMON ANTIGEN COVID
TEST ON THE MARKETS.
YOU HAVE TO TRANSPORT SMALL
AMOUNTS OF EQUIPMENT AND
MANIPULATE AND WAIT OR THE
RESULT AND ON TOP OF THAT
VISUALLY READ THE RESULT WHICH
ISN'T ALWAYS ACCURATE ESPECIALLY
FOR AGING POPULATION WHO IS LOWE
VISION AND WE PARTNERED AND CAME
UP WITH A SIMPLIFIED VX READER.
WITH THIS SORRY, SIMPLIFIED DX
SYSTEM.
WE HAVE A READER VERY COST
EFFECTIVE.
>> $5 TO $10 WITH ACCESSIBILITY
FEATURES AND YOU IT'S DISPLAYED
VISUALLY ON THE SCREEN AS WELL.
YOU CAN CHECK IT OUT LATER.
>> THAT'S ONE COMPONENT AND A
TEST CARTRIDGE WITH A
FLUORESCENT STRIPPING, HIGH
PERFORMANCE AND A SWAB.
YOU POWER ON THE READER.
STEP TWO YOU INSERT THE
CARTRIDGE INTO THE READER AND
STEP THREE YOU CONNECT AND
INSERT SWAB AND YOUR DONE.
THE READER WILL START TO COME
DOWN IN 15 MINUTES AND SHOW THE
RESULT.
>> VERY SIMPLE.
THAT'S OUR VISION.
BEHIND THE READER AND THE
TECHNOLOGY.
I THINK THAT COVERS BASICALLY
EVERYTHING ON THE SLIDE HERE.
AS FRANK WAS SAYING THE READER
TECHNOLOGY M POD BRINGS AND THE
INNOVATION IS BEING ABLE TO USE
LOW COST, HIGH VOLUME DESIGNS IN
OUR DESIGN FOR THE HERRED WEAR
EMPOWERING THE INTELLIGENCE FOR
INTERPRETING THE TEST FOR THE
MODEL AND THAT ALLOWS US TO
BRING SIMPLIFIED STRATEGIC
BALANCE BETWEEN HIGH PERFORMANCE
AND AFFORDABILITY AND BRING THAT
AS FAR AS A VISION FOR THE POD
STARTING WITH THE MULTIPLEX OF
COVID AND FLU A/B AND HAVE
DIFFERENT TEST STRIPS.
>> IT'S GOING TO BE A TRUE
PLATFORM TECHNOLOGY AND WE'RE
EXCITED TO SEE WHERE IT TAKES US
FROM HERE.
OKAY.
WELL, WE WOULDN'T BE HERE
WITHOUT RADX.
THANK YOU ALL FOR HAVING US AND
PROVIDING US WITH THE
OPPORTUNITY.
AS FAR AS NEEDS AND CHALLENGES
GO WE'RE CURRENTLY WORKING
THROUGH OUR WORK PACKAGE 1 AND
WOULD LIKE TO GET ON THE SCALING
UP SIDE AND OUR VISION TO MAKE
THIS POSSIBLE IN A $5 PER TEST
COST IS LEVERAGING ALL THE
TECHNIQUES TO MAKE IT HAPPEN AND
AS FAR AS OPPORTUNITIES TO
COLLABORATE IF THERE'S ANYONE
OUT THERE THAT HAS A MUTUALLY
BENEFICIAL BUSINESS COME SEE US.
WE'LL BE UPSTAIRS AFTER THE
PITCH.
THANK YOU VERY MUCH.
NEXT IS TALKING ABOUT COVID-19
AND FLU A/B COMBO TEST.
GOOD AFTERNOON, EVERYONE.
I'M A LEAD WITHIN THE AXIS BIO
AND IT'S MY HONOR TO SPEAK TODAY
AND TO BE PART OF THE NATIONAL
MECHANISM FOR ACCELERATING THE
DESIGN, DEVELOP THE AND
DISSEMINATING THE PRODUCT FOR
WHERE IT'S NEEDED MOST.
SO TODAY I'D LIKE TO TALK ABOUT
ONE OF THE RADX TYPE 3 SUPPORTED
PROJECTS FOR DEVELOPING OUR
ANTIGEN TESTING WITH MULTIPLEX
CAPABILITY FOR COVID FLU A/B AND
RSV.
OUR TEAM WAS FOUNDED IN THE
EARLY 2000s AND WE'VE BASKETBALL
PARTNERING WITH THE BILL AND
MELINDA GATES FOUNDATION AND
W.H.O. AND UNICEF AND BEFORE
COVID OUR MAJOR PRODUCT WAS FOR
THE MALARIA ANTIGEN TESTING KIT
DISTRIBUTING FOR THE LOW-INCOME
COUNTRIES.
NOW WE'RE GETTING SOME OF THE
SUPPORT FOR OUR TESTING KITS
SELLING MILLIONS OF OUR TEST
KITS NATIONWIDE AND GETTING THE
RADX TYPE 3 SUPPORT FOR THE
ASSAY.
THE CLINICAL NEED WE'RE TRYING
TO ACHIEVE IS BUILD THE ANTIGEN
TESTING PLATFORM SENSITIVITY TO
THE MOLECULAR DIAGNOSTICS WITH
COST EFFECTIVENESS COMPARED WITH
THE PCR ASSAYS AND HIGH
SENSITIVITY TO MINIMIZE THE RISK
WITH THE CURRENT LFAs.
THESE WERE THE TARGET AND WE'RE
CLOSE TO ACHIEVE THOSE YET
BEFORE THE CLINICAL STUDIES BUT
IN THE IN-HOUSE TESTING SHOWS
SIMILAR RESULT FOR OUR SPECS.
BASICALLY IT'S A SIMPLE DESIGN
WITH THE TRADITIONAL LFA
CASSETTES BUT EVERY COME SOME OF
THE INHERENT LIMITATION BY
HAVING THE ADAPT ER SEAMLESSLY
INTEGRATED AND CONTROLLED FOR
IMMUNOCOMPLEXES DURING THE
SOLUTION, DESCENDING THROUGH THE
ADAPTER AND THEN PROPAGATE
TOWARD THE OTHER END OF THE TEST
STRIP TO RETURN THE RESULTS.
OUR ENHANCED PERFORMANCE
STANDARDS SHOW SUCH CONTROL OF
THE SPECIAL TEMPORAL ASPECTS OF
THE IMMUNOCOMPLEX FORMATION WE
WERE ABLE TO OFFER SOME OF THE
MORE REFINED AND EFFECTIVE
DIAGNOSTIC TOOL FOR THE MARKETS
AND SO WE ARE UTILIZING THE
SPECIMENS AND WE CAN DO A LOT
FOR PROVIDING THE TEST KITS
NATIONWIDE AND DEPENDING ON THE
PRODUCTION AMOUNTS BUT I THINK
WE CAN DO SIMILAR FOR OUR SINGLE
PLEX ASSAYS AND LIKE I MENTION
WE'RE APPROACHING TO THE TARGET
SPECS FROM THE INITIATED
PROJECTS AND EXPECTING TO START
OUR CLINICAL STUDY FOR THE
CURRENT FLU SEASON AND LAUNCH
OUR PRODUCT BY NEXT YEAR AND
CURRENTLY WE SUBMITTED PRE
SUBMISSION FOR EUA AND COMPLETE
OUR VALIDATION FOR FDA
SUBMISSIONS AND OUR CURRENT
CAPACITY SITTING OVER 2 MILLION
TEST KITS WITH THREE SHIFT,
24/HOUR RAMP UP PERIOD AND WOULD
LIKE TO IMPACT THE CURRENT
MARKET HELPING THE HOSPITAL
MANAGING THE NECESSARY TOOLS AND
OUT PATIENTS GAINING MOST
BENEFIT IDENTIFYING THREE
DIFFERENT DISEASES FOR THE RIGHT
TREATMENTS AND WE HOPE TO GET
MORE FUNDING FOR CLINICAL STUDY
SWLTZ THE ITEP PROGRAM AND
HOPEFULLY WE'LL WORK WITH NIAID
AND NCI AND OTHER AGENTS FOR
MORE FOR PROJECTS AND MORE
FUNDING.
THANK YOU.
>> NEXT DR. TRIPP WILL TALK
ABOUT THE PORTABLE PCR FOR
LOW-COST VIRAL LOAD AND SCA
TESTING.
>> I'M ALEX CO-FOUNDER AND CEO
OF PUMPED.
WE KNOW A TEST NEEDS TO BE FAST,
ACCURATE AND AFFORDABLE.
THAT'S WHY WE'RE BUILDING THE
RAPID SAMPLE TO ANSWER PLATFORM
IN THE FORMAT WHERE THE TOOLS
ARE AS SIMPLE AS POSSIBLE.
THE RE-AGENTS AND ALL THIS IS
AUTOMATED WITH A COUPLE MAGNETS
AND MAGNETIC FEEDS FOR A TRULY
LOW-COST SOLUTION.
WE ALSO KNOW CLINICAL DECISIONS
RELY ON MORE THAN JUST A YES OR
NO ANSWER.
WE'RE GOING BEYOND THE VIRAL
FLOW READOUT AND LOOKING AT DRUG
RESISTANCE, CAN WE USE ASSAY TO
GENOTYPE DRUG RESISTANT MARKERS
TO NOT ONLY TELL YOU WHAT THE
PATHOGEN IS BUT WHAT TO TREAT IT
WITH AS WELL AND LOOKING AT
QUANTIFICATION TO TRACK VIRAL
LOAD, MONITOR RESPONSE TO
TREATMENT AND MONITOR SEVERITY
OF DISEASE.
AND WE'VE SHOWN WE CAN DETECT
PROTEINS USING THE SAME PLATFORM
FOR SEROLOGY AND MULTI-MODAL
INSIGHT INTO PATHOLOGY.
WITH THE PUMP PLATFORM YOU GET A
PORTABLE BATTERY POWERED
INSTRUMENT YOU CAN BRING TO ANY
SETTING AND LOW-COST CARTRIDGE
WE CAN MAKE FOR A COUPLE
DOLLARS.
WE RECEIVED A LOT OF SUPPORT AND
DEVELOPED THIS 15-MINUTE
GONORRHEA TEST WITH A HIGH
SENSITIVITY AND SPECIFICITY AND
100% PREDICTION OF SUPER FLUX
AND RESISTANCE.
WE'RE CONTINUING TO DEVELOP AN
ASSAY TO DETECT RESISTANCE.
WITH THE NORTHWESTERN POCTRN
WE'RE GETTING SUPPORT TO DEVELOP
AN HIV VIRAL LOAD TEST PROVIDING
PATIENTS AND CLINICIANS TO
DETERMINE IF THE PATIENT
RECEIVING THERAPY IS MAINTAINING
VIRAL LOAD SUPPRESSION OR NEED
TO ADJUST THEIR TREATMENT.
WITHIN THE STI SPACE WE'RE ALSO
LOOKING AT THE RISING CASES OF
SYPHILIS AND INTEGRATING THE
ENTIRE WORKFORCE OF DETECTION
AND DIAGNOSTICS INTO A SINGLE
CARTRIDGE AND DELIVERING SAMPLE
TO ANSWER RESULTS WITHIN A
30-MINUTE TIME FRAME.
THE SINGLE VISIT TO THE CLINIC,
PATIENTS CAN GET PRECISE AND
TARGETED IMMEDIATE CARE.
WE'RE LOOKING FOR CLINICAL TRIAL
SUPPORT, PLANNING AND EXECUTING
OUR FEE FOR BENEFIT TRIALS AS
WELL AS GETTING THROUGH
REGULATORY HURDLES AND WE'RE
ALSO OPEN TO COLLABORATIONS ON
SCALING UP OUR MANUFACTURING AND
ASSAY DEVELOPMENT AS WELL AS
EXPLORING APPLICATIONS IN
RESEARCH USE IN LOW RESOURCE
SETTINGS, OUTREACH AS WELL AS
APPLICATIONS AND SURVEILLANCE.
PLEASE LET ME KNOW IF YOU'D LIKE
TO TALK MORE UPSTAIRS AT OUR
BOOTH.
THE REST OF THE TEAM ARE THERE
AND HAPPY TO TALK MORE ABOUT
PUMPED WHEN YOU COME VISIT US
UPSTAIRS.
NEXT WILL BE ON INFECTIOUS
DISEASES.
>> I'M HEAD OF COMMERCIAL AT
PROMMINEX AND WE ARE DEVELOPING
A FIVE-MINUTE LOW-COST OVER THE
COUNTER MICROTEST THAT'S
REUSABLE AND BASED IN SAN DIEGO
AND THIS IS OUR FIRST INROADS
INTO IDB DEVELOPMENT.
WE EXPERIENCED DEVELOPING ASSAYS
INSTRUMENTATION AND LEADING
MANUFACTURERS BUT OUR FIRST
INROADS INTO THE OTC MARKET SO
WE'RE EXCITED ABOUT THAT AND
FORTUNATE TO PARTNER WITH THE
FOLKS AT RADX AND I BELIEVE
WE'RE THE ONLY COMPANY TO HAVE
BEEN SELECTED FOR THE HIGH
PERFORMANCE AND ACCESSIBILITY.
I'M EXCITED ABOUT THE PROGRESS
WE'VE MADE UNDER BOTH OF THOSE
PROGRAMS.
SO WHAT'S THE CLINICAL NEED?
WE TALKED A LOT ABOUT THIS
YESTERDAY AND TODAY.
LOW COST, RAPID, EASY TO USE AND
MOLECULAR IN THE HOME SETTING,
NON-MEDICAL SETTINGS AND ONE
ACCESSIBLE USED BY LOW VISION,
IMPAIRED AND DEXTERITY RELATED
ISSUES AND USED IN BOTH
POPULATION WE THINK WE HAVE A
GOOD SOLUTION FOR THAT.
WHAT IS OUR INTEL INSIDE.
WHAT TECHNOLOGY DO WE USE?
WHEN WE WENT TO DEVELOP A
TECHNOLOGY WE THIS ENABLES US TO
DO A FIVE-MINUTE TURNAROUND TIME
FOR THE ASSAY BUT WE DIDN'T
REINVENT THE DETECTION
TECHNOLOGY.
WE WANTED TO DESIGN A SYSTEM TO
BE LOW COST.
WE CAPITALIZED ON WHAT'S USED IN
PREGNANCY AND OVULATION TEST AND
WE KEEP OUR COSTS EXTREMELY LOW.
THE COST FOR THE REUSABLE
INSTRUMENT AND THE ASSAY IS LESS
THAN $2.
YOU DO THE MATH AND CAN SEE IT
HOLDS DECENT MARGINS.
ONE UNIQUE FEATURE OF THE SYSTEM
IS THE INSTRUMENT ASSAY AGNOSTIC
WITH A UNIVERSAL DESIGN AND THE
STRIP IS UNIVERSAL.
ACROSS EVERY ASSAY THE STRIP
REMAINS EXACTLY THE SAME.
WE CAN MASS PRODUCE THESE AND
REDUCE COSTS AND FROM THE
GOVERNMENT PERSPECTIVE IT
ENABLES THEM TO BE ABLE TO
STOCKPILE THESE FOR EMERGING
PATHOGENS.
CLINICAL AND ANALYTICAL
PERFORMANCES ARE GOOD.
WE'RE MAKING GOOD HEADWAY IN
COVID AND THE ASSAY AND GOOD
SENSITIVE FOR OUR TESTS ON
GONORRHEA.
IT DIFFERS AT OTC AND POINT OF
CARE.
WANT TO DELIVER A GOOD MOLECULAR
PRODUCT TO THE HOME.
THERE'S A NUMBER ON THE MARKET
TODAY AND A LOT OF THEM HAVE
FAILED.
I THINK IT'S MAINLY DUE TO THE
COST AND IT'S $70 AND GET IT
PAID FOR AT THE PCP.
WE DON'T HAVE AN ACCESSIBLE
PRODUCT FOR FOLKS WITH THE
CHALLENGES.
I THINK WE'D ALL AGREE THERE'S
TOO MUCH USE OF TREATMENT AND
THE ABILITY FOR A PHYSICIAN TO
TEST AND TREAT AND WEDGE WITH
THIS ABILITY TO DIAGNOSE WITHOUT
FOLLOW-UP.
IT'S GOT TO BE CHEAP AND LOW
COST.
PHYSICIANS WILL NOT BRING IT IN
IF IT'S ABOVE THEIR
REIMBURSEMENT RATE.
THEY'RE IB BUSINESS TO MAKE
MONEY AS WELL.
RIGHTFULLY SO.
FUNDING AND CHALLENGES AND
ADDITIONAL FUNDING THERE WOULD
BE GREAT AND THEN OUR TEAM HAS A
LOT OF EXPERIENCE WITH TB ASSAY
DEVELOPMENT AND WE HAVE A
PASSION FOR LMIC SETTINGS AS
WELL.
IN SUMMARY WE FEEL OUR SYSTEM
WORK FLOW IS SIMPLE.
WE HIT ON THE KEY ATTRIBUTES OF
THE SYSTEM WE TALKED ABOUT FOR
BOTH U.S. BASED AND LMIC
SETTINGS.
WE'RE SUPER EXCITED TO GET THIS
OUT TO THE PUBLIC.
THANK YOU VERY MUCH.
SHE'S GOING TO TALK ABOUT THE
MULTIP
MULTIPLEX.
>> AT SAVROS WITH RADX FUNDING
WE ARE DEVELOPING A HIGH
PERFORMANCE OVER THE COUNTER
SINGLE USE MULTIPLEX RESPIRATORY
HEALTH TEST THAT DETECTS, COVID,
FLU A AND B AND RSV A AND B.
THIS IS A PLATFORM TECHNOLOGY
AND UTILIZES RECOMBINASE AND I
THINK WE CAN ALL AGREE THE UPPER
RESPIRATORY PATHOGENS ARE IN
DISTING WISHABLE ALONE AND NEED
THE TIME TO TEST RESULTS, LOW
COST TESTS TO ENCOURAGE PEOPLE
TESTING.
-- INDISTINGUISHABLE AND THE
TESTS NEED TO PROVIDE ACTIONABLE
INFORMATION TO THE CLINICIAN AND
INDIVIDUAL.
I LIKE WHAT SCOTT FROM APTITUDE
SAID YESTERDAY HE SAID I'M
WEARING A CONTINUOUS GLUCOSE
MONITORING DEVICE NOT BECAUSE HE
HAS A CHRONIC DISEASE BUT TRYING
TO CHANGE HIS BEHAVIOR.
I THINK THAT'S REALLY WHAT WE'RE
TRYING TO DO HERE.
TO EMPOWER INDIVIDUALS IN THEIR
HOME IN THE DECENTRALIZED
SETTINGS TO TAKE OWNERSHIP OF
THEIR HEALTH AND CHANGE
BEHAVIORS.
THE SAVROS LEADERSHIP IS
COMPRISED OF INDUSTRY VETERANS
WITH DECADES OF EXPERIENCE IN
POINT OF CARE AND OTHERS.
WE HAVE A HIGH PROTOTYPING AND
DESIGN TO MANUFACTURING BECAUSE
THAT'S ONE OF OUR CENTRAL TENETS
AND SAVROS HAS A COMMERCIAL
SCALE UP AND SALES AND MARKETING
TEAM AS WELL.
WHEN WE WERE DEVELOPING THIS
PRODUCT AND WE'VE AGAIN IN THE
RADX PROGRAM ABOUT SIX MONTHS WE
WERE INNOVATING FOR MULTIPLEX
PERFORMANCE AND LOW COST.
THE WAY WE DO THIS AND ONE OF
THE THINGS WE HAVE PROVEN OUT IS
THE ABILITY TO SIMPLY
ENGINEERING AND I'LL GIVE AN
EXAMPLE.
WE'VE SHOWN WE CAN DO WHAT WE
CALL SINGLE AMPLIFICATION AND
DETECTION.
WE BASICALLY ENZYMATICLY DETECT
AND YOU DONT HAVE TO MOVE FLUID
AROUND, ETCETERA.
WITH REGARDS TO THE USER WE NEED
TO MAKE IT SIMPLE.
IT'S DESIGN TO BE AN OVER THE
COUNTER TEST.
REALLY COLLECT A SWAP AND PUT IT
INTO THE DEVICE AND THAT
ACTIVATED THE DEVICE.
ALL THE BUFFERED REAGENTS,
ETCETERA ARE ON BOARD.
AND I THINK YOU HEARD IT SEVERAL
TIMES HERE AND I'LL SAY IT GOOD.
WE IGNORE COST AT OUR OWN PERIL.
WE'RE DESIGNING FOR A LOW-COST
OF GOODS FOR THIS TEST AND I
THINK WE CAN GET THERE BECAUSE
OF OUR CAPABILITY FOR OUR
MANUFACTURING NEXT WAY WE THINK
OF MANUFACTURING IS HOW CAN WE
DO THIS SIMPLY AND REAL METHODS
AND MOVING AWAY FROM INJECTION
MODELLED PLASTICS, ETCETERA.
SO YOU HEARD NOT JUST THIS TEST
BUT EVERY TEST YOU'VE SEEN HERE
IN THE SHOWCASE WILL CHANGE THE
WAY PEOPLE DO TESTING AND IT'S
GOING TO CHANGE THE WAY THEY
INTERACT WITH THEIR HEALTH CARE
SYSTEMS.
I DO WANT TO REMIND EVERYONE
THERE'S STILL NEEDS AND
CHALLENGES.
ONE OF WHICH WE SHOULD NOT
FORGET ABOUT IMPLEMENTATION
STUDIES AND NEED TO ENGAGE
PAYERS.
YOU HEARD EARLIER IN THE TALKS
ABOUT REIMBURSEMENT.
THAT'S SOMETHING THAT WE DO NEED
TO KEEP OUR EYE ON BECAUSE
THAT'S GOING TO BE CRITICAL FOR
ADOPTION OF AT-HOME TEST WITH
REIMBURSEMENT OR INCENTIVES OR
WHATEVER THE STRUCTURE LOOKS
LIKE.
AND FINALLY, WE WELCOME
COLLABORATIONS IN ALL SHAPES AND
SIZES.
IF YOU HAVE AN ASSAY THAT YOU
WOULD LIKE TO PUT ON OUR
PLATFORM, WE'RE MORE THAN HAPPY
TO WORK WITH YOU.
PLEASE COME TALK TO ME.
IF YOU'RE INTERESTED IN OUR
PRINTED HYBRID ELECTRONICS OR
OUR THOROUGH FORM CAPABILITIES,
TALK TO US AS WELL.
AND WITH THAT, I THINK WE'RE ALL
HERE TO CHANGE HOW TESTING IS
DONE AND IT'S TOGETHER WE CAN
MAKE THE DIFFERENCE.
THANK YOU.
>> NEXT SPEAKER IS HAVE RHYS
UNIVERSITY AND TALK ABOUT THE
MICROFABRICATED SYSTEMS USING
TWO PHOTON POLYMERIZATION BASED
MANUFACTURING.
>> MY PRESENTATION IS SLIGHTLY
DIFFERENT THAN OTHER SHOWCASE
PRESENTATIONS.
PART OF THE PROGRAM JUST ADDED
TO THE SYSTEMS AND MY GOAL IS TO
SHARE INFORMATION ABOUT OUR
CAPABILITIES AND TO START
COLLABORATIONS AND TO ENABLE AND
ALLOW USING OUR FACILITY BY
OTHER CENTERS.
SO TO GIVE YOU A LITTLE BIT OF A
BACKGROUND FOR MANY YEARS WE'VE
BEEN DEVELOPING IMAGING CON
SENSING SYSTEMS FOR DIAGNOSTICS
FOR POINT-OF-CARE TECHNOLOGY.
ALL THE TECHNOLOGIES WERE OFTEN
TIMES TEDIOUS AND EXPENSIVE AND
REQUIRING VERY SPECIALIZED
EXPERTISE.
AND EVEN THOUGH THERE WERE
INDUSTRIAL LEVEL SYSTEMS TO
TRANSITION THEM EASILY INTO MASS
PRODUCTION WAS CHALLENGING IN
SOME APPLICATIONS.
AND RIGHT NOW WE ARE IN A VERY
GREAT MOMENT OF COMING TO THE
MARKET POLYMERIZATION TECHNIQUE
WHICH IS AROUND FOR MANY YEARS
BUT ONLY NOW WHEN IT'S BECOMING
VERY PRACTICAL.
WE ARE FORTUNATE TO HAVE THE
SYSTEM FOR DEVELOP USE FOR TWO
PHOTON POLYMERIZATION AND HIGH
RESOLUTION AND OPTIMIZED FOR
MAKING PARTS.
AND THE SYSTEM IS SHOWN HERE ON
A PICTURE BUT I HAVE TO POINT TO
TWO ELEMENTS TO IT.
ONE IS OPTICAL COHERENCE
TOMOGRAPHY OBJECTIVE WE WORKED
WITH OUR COLLABORATOR AT USC.
IN THE PAST THEY SPENT THREE TO
FOUR WEEKS FOR THEIR STUDIES AND
PRINT SEVERAL OF THEM IN WEEKS
AND OPTIMIZED THEM AND THE OTHER
IS FOR IMAGE SPECTROSCOPY AND
HAVE TO USE TECHNOLOGY TO MAKE
THEM SO ALONG WITH THE NEW
TECHNOLOGY WE HAVE ALSO
ADDITIONAL TECHNOLOGY LIKE
DIAMOND TURNING AND INJECTION
MODELLING AND ALL SERVING AS A
REFERENCE TOOLS AND OVER THE
YEARS WE DEVELOPED A LOT OF
DIFFERENT SYSTEMS AND WITH OUR
PROGRAM WE WANT TO DEVELOP
RELIABLE REPEATABLE TOOLS AND
SENSING APPLICATIONS.
AS WE DEVELOP NEW PROTOCOLS FOR
COLLABORATION IT WOULD BE EASY
TO CONTACT ME AND AS THE TIME
PROGRESSES WE PROBABLY WILL
DEVELOP MORE STREAMLINED WEB
FORM TO SUBMIT IDEAS TO US AS TO
COLLABORATE.
AND WE FABRICATED A FEW EXAMPLES
AND SHOWN AN OBJECTIVE FOR OCT
AND FIBER BUNDLES FOR SPECIAL
IMAGING AND SIGNALLING.
THANK YOU.
>> NEXT SPEAKER IS DR. DAVID
NEILSON TALKING ABOUT THE PCR
PLATFORM FOR FLU A/B AND THEN
RSV.
>> THANK YOU AND THANKS TO THESE
OTHER PRESENTERS.
I'VE BEEN IN DIAGNOSTICS FOR 30
YEARS.
IT'S REALLY EXCITING TO SEE HOW
THE NEW TECHNOLOGY AND I WAS 7
YEARS OLD WHEN I STARTED, THAT'S
RIGHT.
I WANT IT TELL YOU ABOUT OUR
COMPANY.
WE HAVE 116 EMPLOYEES AND DURING
THE PANDEMIC WE SOLD 35 MILLION
COVID TESTS AND USED THAT
SUCCESS TO START ON THE NEW
PLATFORM AND PUT TOGETHER AN
EXPERIENCED TEAM OF DEVELOPERS.
MANY OF WHOM CAME FROM BIO AND
MOST THE INTELLECTUAL PROPERTIES
ON OUR TEAM.
AND STILL PROVIDING AND WE
INTEND TO SELL OUR INSTRUMENT
FOR AROUND $300 AND TEST FOR
$20.
ESE OF USE IS OBTAIN OBTAINED.
DATA IS STORED AND ANALYZED IN
THE CLOUD.
AND THERE'S ANALYSIS AND IT GOES
BACK TO THE USER BUT CAN ALSO BE
SENT TO DOCTORS OR IT CAN BE
SENT TO ANONYMIZED FOR DATA
SURVEILLANCE.
HOW DO YOU GET THE DATA TO ALL
THE PLACES IN A WAY THEY AN USE
IT.
THE SYSTEM'S VERY EASY TO USE.
IN OUR CLINICAL TRIALS WE HAD
750 PATIENTS THAT HAVE
SUCCESSFULLY SELF-TESTED
THEMSELVES IN AN AT-HOME VARIETY
AND COMPARED WELL WITH OUR
ROESCH TEST WE'RE HAVING SICK
PEOPLE COMPROMISED, PEOPLE,
THEY'RE TESTING THEMSELVES ON AN
INSTRUMENT THEY'VE NEVER USED
AND PERFORMING VERY WELL AGAINST
TRAINED LABORATORY TECHNICIANS
ON A PRECISION SYSTEM.
WE WILL BE SUBMITTING AN EUA FOR
COVID IN THE NEXT WEEK OR TWO
AND WE WILL LAUNCH THE TEST WHEN
WE GET THAT APPROVAL.
AND WE EXPECT ANALYTICAL AND
CLINICAL STUDIOS TO BEGIN IN Q1
FOR FLU A, FLU B AND WE HAVE A
MANUFACTURING CAPACITY OF ABOUT
1.2 MILLION CUPS IN OUR CURRENT
FACILITY AND ALSO MAKE OUR OWN
INSTRUMENTS VERTICALLY ORIENTED
AND INTEND TO SEND MOST THE
INSTRUMENT MANUFACTURING TO THE
THIRD PARTIES THAT CAN DO IT
LESS EXPENSIVE THAN WE CAN.
WE WELCOME ADDITIONAL FUNDING
FROM THE NIH FOR A RADX TECH 3
COMPANY AND SUPPORT ADDITIONAL
PRODUCT DEVELOPMENT TO REDUCE
MANUFACTURING COST BOTH
INSTRUMENT AND CONSUMABLE WHICH
TERESA MENTIONED IS A KEY
REQUIREMENT TO GET THE PLATFORM
TO ALL THE PLACES THEY NEED TO
BE.
WE ENVISION THE IDEAL PLACE IS
IN BETWEEN THE POINT OF CARE AND
RETAIL CLINICS OR SKILLED
NURSING FACILITIES.
THOSE ARE PLACES TO START.
AND WHEN WE HELP AND FIGURING
OUT THE COMBINATION OF
REGULATORY APPROVALS AND
REIMBURSEMENT STRATEGIES NEEDED
TO GET IT TO ALL THE DEVICE TO
ALL THE RIGHT PLACES.
AND WE'D ALSO LIKE TO SUPPORT
WAYS TO GET THE DATA OUT OF THIS
SYSTEM AND INTO THE HANDS OF
DOCTORS AND PUBLIC HEALTH
CRISIS.
WHERE THE SYSTEM CAN MAKE A
DIFFERENCE.
I IMAGINE A NETWORK OF
INSTRUMENTS MAYBE MULTIPLE
DEVICES ALL PROVIDING DATA SO
YOU FIGURE OUT WHERE AN ACTIVE
DISEASE SURVEILLANCE SYSTEM
WHERE YOU SEE OUTBREAKS WHERE
YOU SEE SCALE AT REAL TIME.
IT'S REALLY EXCITING.
WE'RE A RADX TECH 3 COMPANY AND
WANT TO ACKNOWLEDGE THE SUPPORT
WE RECEIVED FROM THEM INCLUDING
MANY HERE TODAY AND TODD MERCHAK
AND OTHERS AND THANK YOU VERY
MUCH.
>> NEXT IS SPEAKER IS JOE GOING
TO TALK ABOUT A FAST, ACCURATE
AFFORDABLE PROGRAM FOR AT HOME
DIAGNOSTIC TESTING.
>> HI, ALEXEAU PRESIDENT AND
CO-FOUNDER OF SCOUT.
WE ARE FOUNDED IN 2019 AS OO
LABS.
YOU MAY HAVE RECOGNIZED US BY A
DIFFERENT NAME INITIALLY FOR
OTC, STI TESTING.
THE PROPRIETARY TESTING AND WE
HAD SIX FULL-TIME EMPLOYEES AND
HAD A BIG LIFT AND RECEIVED EUA
IN 2022.
A SHOUT OUT TO RADX WE HAT
SPORED FROM EIGHT OF
ORGANIZATIONS TO GET AN EUA WITH
ONLY SIX PEOPLE.
I WANT TO BRAG WE DID AN ASSAY
TO CLINICAL TRIAL IN NINE MONTHS
AND WERE ABLE TO EXECUTE AND
RECEIVE A CONTRACT IN 2021 BASED
OFF MILESTONES.
TWO CO-FOUNDERS CAM BALL ON THE
LEFT AND MYSELF.
WE MET IN GRAD SCHOOL IN 2010.
THIS IS A PHOTO TO PROVE WE'VE
KNOWN EACH OTHER 13 YEARS AND
HE'S A STAFF SCIENTIST AND
TWO-TIME FOUNDER WITH ONE
ACQUISITION IN 2019 IN THE
DIRECT TO CONSUMER HEALTH SPACE
AND I CAN PROBABLY BREEZE
THROUGH THIS IT'S BEEN SAID LIKE
SEVEN TIMES NOW IN GENERAL,
ANTIGEN TESTS SOME OF THE NEWER
ONES AND FLOW AND WE DON'T HAVE
A PCR MACHINE, DO YOU WANT ONE
PROBABLY IN YOUR LIVING ROOM?
REALLY COMPLICATED MED DEVICE OR
DIAGNOSTIC EQUIPMENT NOT
SUITABLE FOR OVER THE COUNTER.
SO THE NEED IS IF YOU'RE LOOKING
AT THE SPECS, IT'S LIKE FAST,
ACCURATE, AFFORDABLE AND NATS
BEEN SAID LIKE SEVEN TIMES AND
FEEL WHAT WE WANT TO FOCUS ON IS
THE BETTER PATIENT EXPERIENCE
AND KNOWING YOUR RESULT
CONVENIENTLY AT HOME AND QUICKLY
AND IT'S ABOUT CONVENIENCE AND
PATIENT EXPERIENCE AND THAT'S
OUR FOCUS.
TECHNOLOGY LIKE I MENTIONED IS A
PROPRIETARY LAMP CALLED LOOP TO
LOOP AND IMPROVED TIME TO RESULT
AND SPECIFICITY AND REDUCES
COMPLEXITY.
IF YOU GO UPSTAIRS AND LOOK AT
OUR DEVICE IT'S LIKE THIS BIG.
IT'S INEXPENSIVE TO MANUFACTURE
AND PRODUCE AND OBVIOUSLY REALLY
INEXPENSIVE TO MANUFACTURE A
TEST KIT.
IT'S A SCOUT HUB TEST KIT INSIDE
A TUBE AND HAS CONNECT MOBILE
APPS AND RUNS OFF A MOBILE APPS.
TYPES ARE NASAL SWABS, VAGINAL
SWABS AND OTHERS TO BE TESTED.
WHILE OUR RETAIL SALES PRICE AT
LAUNCH IS $25 PER TEST KIT AND
IN MATERIALS OF PERFORMANCE 400
COPIES PER SWAB.
FROM OUR OTC SELF TEST AND
CLINICAL TRIAL WE COMPLETED
RECENTLY OVER ALL AGREEMENT WITH
THE ROESCH AND REGULATORY LIKE I
MENTIONED RECEIVED FDA OR CLIA
WAVE SETTINGS.
AND 250,000 HUBS PER MONTH WITH
NEXT GEN DEVICE CURRENTLY IT'S
LESS THAN THAT.
AND CLINICAL IMPACT FASTER,
EARLIER DETECTION INFECTIOUS
DISEASE.
WE THINK THERE WILL BE SAVINGS
TO PAYERS AND PROVIDERS WITH
DECENTRALIZED TESTING AND IF YOU
IMPROVE THE CONVENIENCE AND IF
PEOPLE HAD A BETTER EXPERIENCE
AND OUTCOME IN TESTING AND
RECEIVING INFORMATION UNTIL
IMPROVEMENT UTILIZATION AND
CHALLENGES, EDUCATION.
HOW MANY COVID TESTS ARE OUT
THERE AND HAVE TO EDUCATE THE
CONSUMER AND PATIENT AND PARTNER
WITH ORGANIZATIONS THAT HAVE
REACH AND AS ANY TEST DEVELOPER
LIMITED TEST MENUS LIKE RATE OF
COVID AND LICENSING AND WE HAVE
CHEMISTRY AND MAKING THE CHAIN
AND IT'S SIMPLE CHEMISTRY.
IF YOU HAVE A TARGET AND WANT TO
GET TO MARKET QUICKLY I THINK WE
COULD BE INTERESTED IN
PARTNERING AND FIGURING OUT A
WAY FOR US TO WORK TOGETHER.
COME FIND ME UPSTAIRS IF YOU'RE
INTERESTED IN LEARNING MORE
ABOUT SCOTT OR OPPORTUNITIES TO
COLLABORATE.
THANKS.
>> NEXT SPEAKER WILL TALK ABOUT
THE MULTI-MODAL SCOPE FOR CANCER
DETECTION.
>> GOOD AFTERNOON, EVERYONE.
MY PRESENTATION WILL ALSO BE A
LITTLE BIT GIVEN THAN YOU'VE
SEEN SO FAR TODAY BUT I'D LIKE
TO TELL YOU ABOUT A TECHNOLOGY
WE'VE DEVELOPED AT RHYS
UNIVERSITY CALLED THE MULTIMODAL
MULTI-SCOPE FOR REAL TIME
CERVICAL CANCER DETECTION IN
COLLABORATION WITH OUR PARTNERS
IN THE U.S. AS WELL AS THOSE
THROUGHOUT BRAZIL.
THE NEED THE TECHNOLOGY HELPS TO
ADDRESS IS LIMITED ACCESS TO
EXPERT CULPOSCOPY.
THE SCOPE CAN RUN UPWARDS OF
$20,000 AND USED THE CLINICIAN
TO TAKE BIOPSIES SENT TO A PATH
LAB.
THE OVER ALL PROCESS OF CANCER
IS TIME, MONEY AND RESOURCE
INTENSE IIVE IT'S POINT OF CARE
FRIENDLY AND USED TO IMAGE THE
PATIENT AT THE POINT OF CARE.
TO WALK THROUGH THE WORK FLOW,
YOU START OFF BY IMAGING THE
CERVIX AFTER APPLYING ACIDIC
ASIT AND THE PHOTO IS THEN RUN
THROUGH OUR ALGORITHM.
YOU CAN SEE A COUPLE EXAMPLES ON
THE RIGHT IS THE LESION WHICH
IS SHOWN IN THE OUTLINE IS WHERE
THE HEAT MAP PREDICT THE LESION
TO BE.
OVER ALL WE HAVE A PRETTY GOOD
INTERSECTION SECTION OF WHAT THE
HEAT MAPS ARE DISPLAYING AND
AUTOMATED FASHION AND THE HEAT
MAP SHOWS ALL LOW SCORING
PROBABILITIES.
THE NEXT STEP OF THE MMC IS TO
APPLY A DARK CONTRAST STAIN AS
WELL AS A FLUORESCENT STRAIN AND
THE IMAGE WITH THE HIGH
RESOLUTION ENDO COPE AND AFTER
YOU PLACE A PROBE DIRECTLY ON
THE SURFACE YOU CAN SEE THE
NUCLEI FLORESING IN REAL TIME
AND SEE HOW DIFFERENT A NORMAL
VERSUS AN ABNORMAL IMAGE LOOKS
LIKE AND AFTER RUNNING THROUGH
THE MODEL IN A STUDY OF 320
PATIENTS WE WERE ABLE TO
ACCURATELY DIFFERENTIATE BETWEEN
LOW OR NORMAL PATIENTS AND
HIGH-GRADE PRE CANCER, CANCER
WITH GOOD AC AND COMPARABLE
DEPRESSION WHILE SEEING
COMPARABLE SPECIFICITY IF NOT
SLIGHTLY BETTER.
OVER ALL THE DEVICE COSTS ARE
AROUND $500 FOR THE COLPOSCOPE
AND OVER ALL I HOPE I'VE
CONVINCED YOU THERE'S POTENTIAL
FOR IMPACT BY ELIMINATING THE
NEED FOR COLPOSCOPY AND WE'RE
CURRENTLY OPTIMIZING THE DEVICE
AND MOVING FORWARD WITH A 760
PATIENT PROSPECT VALIDATION
STUDY IN AT TWO SITES IN BRAZIL
TO OVERCOME THE CHALLENGES AND
I'D LOVE TO SPEAK WITH ANYONE
UPSTAIRS TO DISCUSS
COLLABORATION.
THANK YOU.
>> THIS PLATFORM WAS FUNDED AT
THE INITIAL STATUS.
>> THANK YOU.
IT MAY TAKE A WHILE HERE.
WE'RE PUSHING THE LIMITS OF THE
2016 VERSION POWER POINT.
>> GOOD EVENING, I HAVE THE
RESEARCH OUT OF DURHAM, NORTH
CAROLINA.
HAPPY TO BE HERE.
I HAVE THREE SLIDES.
THE FIRST SLIDE I'M GOING TO
SHOW YOU THE COMPANY'S CORE
TECHNOLOGY, ELECTROWAVE
TECHNOLOGY WHICH MAY NOT BE
FAMILIAR TO EVERYBODY IN THE
AUDIENCE.
SECOND SLIDE IS SHOWING HOW
WE'RE TAKING THE TECHNOLOGY AND
BUILDING OUT A TESTING PLATFORM
FOR A VARIETY OF PATIENT CARE
ENVIRONMENTS AND THE THIRD SLIDE
I'LL END WITH THE PRELIMINARY
DATA WE HAVE WORKING WITH RADX
HIV PROGRAM.
I'D LIKE IT START THE PITCH WITH
A QUESTION, WHAT IF YOU CAN RUN
A SINGLE PLATFORM?
SO THAT'S THE GOAL OF WE'RE
TRYING TO DO AND HOPEFULLY WE'LL
GET THERE SOON.
I'LL START BY EXPLAINING WHAT
DIGITAL MICROFLUIDICS IS SOME
PEOPLE CALL ELECTROWEDDING
MOVING DROPLETS USING
ELECTRICITY PRECISELY.
THIS TAKES PLACE ON A PRINTED
CIRCUIT BOARD WE CAN MAKE SMALL
OR BIG.
WE MOVE DROPLETS WITH
ELECTRICITY NOT WITH PUMPS,
VALVES, VACUUM.
THERE ARE NO MOVING PARTS.
EVERYTHING IS SOLID STATE.
YOU MOVE DROPS WITH ELECTRICITY.
SIZE OF THE DROPLETS WE CAN MOVE
RANGE FROM 300 NANO LITERS WHICH
IS SHOWN HERE TO TENTHS OF
MICROLITERS.
WE CAN DISPENSE DROPS AND
RAPIDLY MIX DROPS SO THIS IS A
FLUORESCENT DIE WITH A
NON-FLUORESCENT DROPLET AND SEE
RAPID MIXING.
YOU CAN MOVE AND MIX DROPLETS
AND START BUILDING AN ASSAY.
WHAT ELSE CAN WE DO?
WE CAN WASH AND INTERACT WITH
BEATS.
YOU CAN SEE BEATS BEING
MAGNETIZED AND OPENS UP
IMMUNOASSAYS AND I'LL EXPLAIN
THE UNIQUE WAY WE DO PCR.
INSTEAD OF CYCLING THE
INSTRUMENT UP AND DOWN WE
ACTUALLY HAVE TWO ZONES ON THE
CARTRIDGE.
YOU CAN SEE THE FLUORESCENCE
GETTING BRIGHTER AND BRIGHTER
AND IS CYCLE THE DROPLETS BACK
AND FORM AND THERE'S NO THERMAL
MASS TRANSFER.
WE CAN DO MULTIPLEX CPR TO
DESIGN EVERYTHING IN A LOOP.
WE CAN CYCLE THE DROP LETS UNDER
THE SAME DETECTER AND GET
MULTIPLEX PCR.
WE HAVE FOUR COLORS AND CAN DO
FOUR AND 16 AND TWO DETECTERS TO
32 PLEX ON THE INSTRUMENT AND
THIS IS A NEW TELEHEALTH
DEVELOPED IN THE LAST TWO YEARS
OR SO.
THIS IS THE KEY.
AS WELL AS FOR
MULTI-FUNCTIONALITY ABILITY AND
THAT IS TO MEASURE THE
PROPERTIES ON THE CARTRIDGE.
SO THAT'S A VERY IMPORTANT
MEASUREMENT FOR COAGULATION
ASSAYS.
THIS IS AN APTT ASSAY FROM WHOLE
BLOOD.
YOU'LL SEE THE DROPLET WILL
START TO GLUTINATE -- TO
COAGULATE AND THE DROPLET STARTS
TO MOVE IN A DIFFERENT WAY AS IT
STARTS TO COAGULATE AND PREC
PRECISELY MEASURE WHEN THE DROP
IS COAG LATING.
ALL THIS CAN BE WRAPPED UP IN A
SINGLE CONSUMABLE.
I CAN TALK ABOUT THIS VIDEO FOR
HALF AN HOUR, WHICH OBVIOUSLY I
WON'T, YOU CAN PERFORM A VARIETY
OF TESTS ON A SINGLE CARTRIDGE
AND DEFINITELY ON A SINGLE
INSTRUMENT.
SO WHAT ARE WE TRYING TO DO WITH
THIS TECHNOLOGY?
WE'RE TRYING TO CREATE AN ECO
SYSTEM FOR A VARIETY OF PATIENT
CARE ENVIRONMENTS.
WE HAVE TWO PRODUCTS THAT IS
CLEARED BY THE FDA.
ONE IS A PLATFORM FOR NEWBORN
SCREENING.
ONE IN SIX BABIES IN THE
U.S. HAS THEIR BLOOD TESTED ON
THIS PLATFORM IN THE STATE OF
MARYLAND.
IF YOU HAVE A BABY OR KNOW
SOMEONE WHO HAS THEY'RE BABY
WILL BE TESTED ON THE AND THAT'S
OUR FIRST FDA CLEARED DEVICE.
THE SECOND DEVICE IS ONE I'VE
WORKED ON.
WE STARTED DEVELOPMENT OF THIS
DEVICE IN 2015 AND GOT FDA
CLEARANCE IN 2022.
THIS IS POINT-OF-CARE ANALYZER
THAT TAKES ONE CARTRIDGE, ONE
PATIENT SAMPLE AND RUN TESTS ON
IT.
THE FIRST TEST WE ARE LAUNCHING
THIS WITH PD A BLOOD DISORDER.
NOW THE PLATFORM IS CLEARED.
OUR GOAL IS TO CREATE MORE AND
MORE TEST.
WE'RE ALSO PARTNERING WITH BARDA
TO USE OUR PLATFORM FOR HOME
USER AND THAT'S THE KEEPER
PLATFORM WHICH EVENTUALLY WILL
FIT IN THE PALM OF YOUR HAND.
THE TECHNOLOGY IS
MULTI-FUNCTIONAL AND WE'LL BE
ABLE TO RUN ALL THESE ASSAY TYPE
ON A SINGLE PLATFORM AND THE WAY
WE CAN ACCEPT BLOOD AND PLASMA
AND BLOOD GOES IN, RESULTS COME
OUT.
LAST SLIDE IS SOME DATA ON THE
VIRAL LOAD DEVICE.
THE KEY FEATURES IS WE HAVE AN
ONBOARD PLASMA SEPARATION TO
ALLOW THE USER TO PUT EN WHOLE
BLOOD AND GET PLASMA VIRAL LOAD
OUT.
WE NEED TO GET TO 1E3 AND TIME
TO RESULTS IS 30 MINUTES AND
WE'RE LOOKING AT 40.
WE'RE GOING TO WORK ON THAT IN
THE NEXT FEW MONTHS AND END WITH
THE VIDEO SHOWING HOW 150
MICROLITERS OF BLOOD CAN BE
INPUT FROM THE USER AND THE
CARTRIDGE DOES THE PLASMA
SEPARATION ON BOARD SEAMLESSLY.
WE HAVE DATA SHOWING WE CAN
DETECT DIFFERENT SUB TYPES OF
HIV.
THANK YOU VERY MUCH.
>> WHAT A LIVELY TWO DAYS AND I
DON'T KNOW ABOUT YOU GUYS BUT
I'VE BEEN ENRICHED BY THE LAST
TWO DAYS.
THOSE WHO KNOW ME AND WORK WITH
ME KNOW I ALWAYS SAY THE
CLINICAL NEEDS DRIVE THE
TECHNOLOGY DEVELOPMENT BUT NOW
AFTER THE CONFERENCE I WOULD SAY
THE CLINICAL NEED AND INDIVIDUAL
PATIENT NEEDS DRIVE TECHNOLOGY
DEVELOPMENT.
EARLIER THIS MORNING WE HAD
ABOUT 40 MINUTE DISCUSSION ABOUT
DIFFERENT THINGS WE'D LIKE TO
SEE AND THINGS THAT WENT WELL
DURING THE CONFERENCE.
FROM DAY ONE BUT I WOULD LIKE TO
OPEN UP THE FLOOR FOR A FEW
MINUTES IF ANYONE HAS ANY
THOUGHTS FROM THE CONFERENCE OR
THINGS WE SHOULD INCLUDE IN OUR
REPORTS AT THE END.
ANY STRATEGIC CONSIDERATIONS OR
INSIGHT INTO WHAT WE SHOULD KEEP
IN MIND AS WE MOVE FORWARD WITH
POINT OF CARE TECHNOLOGIES.
I'LL OPEN THE FLOOR.
>> THERE WERE SEVERAL SPEAKERS
WHO SUGGESTED THAT THE WAY TO
DOWN SELECT ASSAYS IS LED AND I
DO THINK THERE'S ENOUGHCATION
ENOUGH CASES WHERE LED AND
CLINICAL PERFORMANCE CAN COMPILE
ASSAYS AND CLINICAL PERFORMANCE
AND SEE IS THERE A RELATIONSHIP
BETWEEN THE TWO.
FOR EXAMPLE I THINK POINT OF
CARE TESTS THAT MIGHT HAVE LOUSY
LEDs BUT START PROCESSING THE
SAMPLE WITHIN A MINUTE OF TAKING
IT MIGHT BE BETTER THAN A LAB
STANDARD TEST WHICH YOU FROZE A
SAMPLE AND SHIPPED IT, THAWED IT
AND TESTED IT.
JUST WANTED TO SUGGEST THAT
THOUGHT THOUGHT.
AND THEN IN THE DISCUSSION OF
LOW RESOURCE SETTINGS WHEN YOU
HAVE SYSTEMS WHERE YOU'RE
SECONDING DATA TO THE CLOUD, ONE
THING WE'RE ISAYING DATA STAYS N
OUR COUNTRY.
IF YOU HAVE AN APP TO THE CLOUD
IF IT'S GOING TO A CLOUD
DATABASE IN THE UNITED STATES,
AND DATA GENERATED FOR AN INDIAN
OR SOUTH AFRICAN PATIENT YOU CAN
GET IN BIG TROUBLE IF YOU
HAVEN'T FIGURED OUT HOW TO HAVE
THE APP CENTERED TO THE COUNTRY
AND WORTH KEEPING IN MIND SO YOU
DON'T ACCIDENTALLY GET IN
TROUBLE.
>> THANK YOU FOR THAT INPUT.
>> I THINK IT WOULD BE HELPFUL
TO HAVE A DEFINITION OF WHAT
POINT-OF-CARE TECHNOLOGIES ARE.
I'VE SEEN A BUNCH OF EXAMPLES
AND I'VE ASKED PEOPLE AND THEY
SAID WELL, A BARBERSHOP IS OKAY.
A PSYCHIATRIST OFFICE, UROLOGIST
OFFICE, NO.
I SEE AN EXAMPLE OF A SYSTEM TO
BE PUT INTO AN OPERATING ROOM.
I THINK IT WOULD HELP IN TERMS
OF CLARITY TO UNDERSTAND WHAT IS
THE SCOPE OF WHAT IS A POINT OF
CARE TECHNOLOGY.
THANK YOU.
>> I HAVE A COMMENT ON SILVER
LINING OF COVID IT LEFT US WITH
GREAT TECHNOLOGIES AND WE KNOW
THOSE ARE GOING TO MATURE IN
TWO, THREE, FOUR YEARS.
AND WE NEED TO THINK ABOUT
REGULATORY AND PAYMENT
STRATEGIES NOW.
SO IT'S NOT THE BOTTLENECK IN
THREE OR FOUR YEARS.
I'M JOKING A LITTLE BIT BUT
MAYBE AT THE CONFERENCE NEXT
YEAR WE CAN HAVE A BOOTH FOR
REGULATORY STRATEGY FOR HIV AND
ANOTHER BOOTH FOR REGULATORY
FRAMEWORK FOR ANOTHER THING.
THANKS.
>> ONE MORE.
>> I APPRECIATE WHAT HE'S SAYING
AND WE FUNDED A WHOLE LOT OF
THINGS OVER THE LAST COUPLE
YEARS AND WE'VE CREATED A
VEHICLE TO PRODUCE TECHNOLOGIES
THAT MIGHT -- SOME SERVED IN
COVID.
SOME MIGHT SERVE IN OTHER
PLACES.
AND WE'VE TALKED ABOUT PIVOTING
IN SMALL COMPANIES AND NOW YOU
HAVE THE TECHNOLOGY AND
RESOURCES.
START TO THINK ABOUT WHERE IT
CAN BE APPLIED ELSEWHERE AND
THESE DISCUSSIONS IS GOOD.
WE'VE HEARD A TREMENDOUS AMOUNT
OF INFORMATION AND THE
DISCUSSIONS OF LOW AND MIDDLE
INCOME COUNTRIES AND WHAT THEY
NEED AND HOW TO GET THERE AND
HOW TO GET THE TECHNOLOGIES AND
POINT OF CARE AND DIFFERENT
SCENARIO WHEN YOU'RE TRYING TO
DIAGNOSE CANCER.
IF YOU'RE A RADX ALUMNI OR RADX
COMPANY COMMUNICATE WHAT WORKED,
WHAT DIDN'T AND WHAT YOU FEEL
YOU COULD GET MORE AND YOU HAVE
NOW HAVE A DIRECT COMMUNICATION
IN THE CHAIN OF COMMAND TO SAY
THIS IS WHAT WE LEARNED AND NEED
YOU FROM MOVING FORWARD.
HAVE YOU THE VEHICLES TO
COMMUNICATE WITH THE TEAMS YOU
WORKED WITH.
WE'RE STILL LISTENING AND HAVING
THE CONVERSATIONS NOW.
THEY WILL CONTINUE IF YOU'RE
RESOURCES ARE BECOMING
CONSTRAINED BY VIRTUE OF THE
FACT WE'RE BEYOND THE MENTAL
HEALTH EMERGENCY LOOK FOR
APPLICATION OF OTHER
TECHNOLOGIES WHERE WE'RE STILL
NOT GETTING WHAT WE NEED.
THAT'S JUST A THOUGHT.
IT'S A THING.
IT IS GREAT TO HAVE THE
TECHNOLOGIES AND FIND THEIR
PLACE.
AS INNOVATION WORKS, SOMETIMES
THE ULTIMATE OUTCOME FROM AN
ORIGINAL WE NEED TO USE THIS FOR
THIS PARTICULAR PURPOSE ENDS UP
BEING SOMETHING ELSE COMPLETELY
DIFFERENT.
YOU'RE GOING TO BE RESPONSIBLE
FOR FINDING THAT AND WE'VE GOT A
NUMBER OF -- WE HAVE MASSIVE
INSTITUTES AROUND TO SUPPORT
THESE THINGS AS WE MOVE BEYOND
COVID AND CONTINUING ON WITH THE
MISSION AT HAND AND SOME ARE
GOING TO FIND A PLACE ELSEWHERE.
AND THAT'S ALL I HAVE -- THAT'S
MY RADX PORTFOLIO EXECUTIVE.
WE'VE ALL EXPERIENCED SOMETHING
THAT IS TRAUMATIC IN SOME CASES.
WE ALL RESPONDED TO A
SIGNIFICANT ISSUE THAT FACED ALL
HUMANITY.
YOU'RE ALL THE TECHNOLOGY
DEVELOPERS AND YOU'RE THE
GOVERNMENT, THE INDUSTRY, THE
COMMERCIALIZATION EXPERTS.
WE ALL CAN WORK TOGETHER BUT IT
WOULD BE GREAT TO SEE SOME OF
THE TECHNOLOGIES FIND THEIR WAY
IN PLACES YOU WEREN'T THINKING
ABOUT TWO YEARS AGO THAT'S ALL I
HAVE TO SAY.
THANK YOU VERY MUCH.
>> THANK YOU.
>> I'M VERY GRATEFUL FOR YOU ALL
PUTTING TOGETHER THE EVENT FOR
THE COMPANIES TO MEET EACH OTHER
NOT ONLY BEYOND COVID AND THE
APPLICATIONS YOUR TECHNOLOGIES
ARE GOING TO BE SO FRUITFUL FOR
BUT FOR PANDEMIC PREPAREDNESS IN
THE FUTURE BECAUSE WE HAVE
TURNED OUT EXCELLENT
TECHNOLOGIES AND MAYBE NOT ALL
WILL MAKE IT BUT MAYBE SOME WILL
PARTNERS AND SOME HAVE AMAZING
INSTRUMENTS AND STRUGGLE WITH
CHEMISTRY AND SOME ARE GREAT
WITH CHEMISTRY BUT STRUGGLE WITH
INSTRUMENTS.
IT WOULD BE GREAT TO SEE
SOMETHING COME FROM THAT.
>> WE'RE NOW AT THE END.
I'D LIKE TO THANK EVERYONE WHO
PARTICIPATED AND THOSE WHO
ORGANIZED THE MEETING ESPECIALLY
OUR TEAM LEAD AND ORGANIZATION
TEAM.
AND WE LOOK FORWARD TO THE NEXT
ONE MAYBE IN THE NEXT FEW YEARS.
AND WE DO HAVE A FINAL SLIDE AND
THIS IS FROM YESTERDAY
APPARENTLY.
WE DO ASK THAT YOU DO THE SURVEY
AND ALL SHOULD HAVE RECEIVED AN
E-MAIL.
FILL THAT OUT AND WE ASK I VISIT
OUR TECHNOLOGY SESSION
EXHIBITERS WHO JUST SHARED THEIR
TECHNOLOGIES UP TO 5:30.
THANK YOU EVERYONE.