GOOD MORNING, EVERYONE.
MY NAME IS DR. TIFFANI BAILEY
LASH THE DIRECTOR OF THE NIBIB
POINT-OF-CARE TECHNOLOGY
RESEARCH NETWORK.
I'M CHAIRING THIS WITH
DR. DHAWAN WHO UNFORTUNATELY
COULDN'T BE HERE TODAY.
ON BEHALF OF THE NATIONAL
INSTITUTE OF HEALTH AND THE
NATIONAL INSTITUTE OF BIO
MEDICAL IMAGING AND BIO
ENGINEERING WHERE OUR GOAL IS TO
TRANSFORM THROUGH TECHNOLOGY
DEVELOPMENT OUR UNDERSTANDING OF
DISEASE, ITS PREVENTION,
DETECTION, DIAGNOSIS AND
TREATMENT.
WELCOME TO THE RESEARCH AND
INNOVATION TRANSLATION
PARTNERSHIPS IN POINT-OF-CARE
TECHNOLOGIES CONFERENCE AND
TECHNOLOGY SHOWCASE.
THAT'S A MOUTHFUL.
SO A SHOW OF HANDS FOR THOSE WHO
THIS IS YOUR FIRST TIME AT OUR
BEAUTIFUL CAMPUS AT NIH?
WELL, THANK YOU AND WELCOME.
IF THIS IS YOUR FIRST CONFERENCE
SINCE THE PANDEMIC, PLEASE RAISE
YOUR HAND.
A FEW.
WELL, WE CERTAINLY THANK YOU FOR
CHOOSING THIS CONFERENCE TO
ATTEND.
IT MAY BE YOUR FIRST DAY OF THE
CONFERENCE BUT ACTUALLY THERE
WAS A LOT OF INFORMATION THAT
WAS SHARED THAT TOOK PLACE
YESTERDAY DURING THE SPIR
INFORMATION PRE-MEETING SESSION
LED BY DR. ASHMONT FROM NIBIB.
THERE IT WAS GREAT TO SEE FROM
SELF OF THE PARTICIPANTS THOSE
WHO ARE LEARNING ABOUT THE NIHs
SMALL BUSINESS PROGRAM FROM
THOSE WHO ARE APPLYING, TO THOSE
WHO HAVE APPLIED AND TRYING TO
FIGURE OUT WHAT THEIR NEXT STEPS
ARE.
SO EVEN WITH THAT THE GREAT NEWS
IS THERE WERE NIH PARTNERING
STAFF FROM THE NIH SEED OFFICE
AND NIBIB, NIMHD AND NCCIH THERE
TO HELP.
SO WE ARE THRILLED TO BRING
TOGETHER OVER THE NEXT TWO DAYS
A DIVERSE COMMUNITY OF
RESEARCHERS, TECHNOLOGY,
DEVELOPERS, CLINICIANS, INDUSTRY
PARTNERS, REGULATORY
ADMINISTRATORS, LEADERS,
INVESTORS AND REPRESENTATIVES
FROM ALL THE NIBIB POINT-OF-CARE
RESEARCH TECHNOLOGY CENTERS.
THE OVER ALL GOAL IS TO BRING
THE STAKEHOLDERS TOGETHER TO
LEARN ABOUT THE AVAILABLE
RESOURCES AND RECENT EXPERIENCES
AND OPPORTUNITIES TO DEVELOP AND
ENHANCE COLLABORATIVE RESEARCH
SYNERGIES AND INNOVATION IN
PARTNERSHIPS TOWARDS STRATEGIC
IMPLEMENTATION OF ACCELERATED
TRANSLATION OF POINT-OF-CARE
TECHNOLOGIES FOR THE USERS FOR
HEALTH CARE AND CLINICAL
APPLICATIONS.
WE'RE DOING THIS THROUGH OPEN
FORUMS WITH RESEARCHERS AND THE
STAKEHOLDERS TO DISCUSS HOW TO
FURTHER PROMOTE AND FACILITATE
STRATEGIC PARTNERSHIPS AND
PATHWAYS.
SUCH AS ARCHIVING AND BASE
MODELS AND ASSEMBLE DATA SETS TO
HELP RESEARCHERS AND
INVESTIGATORS FURTHER EXPLORE
THE POTENTIAL SPIN-OFF
APPLICATIONS TO POINT-OF-CARE
TECHNOLOGY INNOVATIONS.
SO WE HOPE YOU SHARE YOUR
DIVERSE EXPERTISE, JOIN IN THE
CONVERGENCE OF MINDS INCLUDING
THOSE STAKEHOLDERS WITH
COMPLEMENTARY EXPERTISE AND
RESOURCES ACROSS THE DIAGNOSTIC
TECHNOLOGY DEVELOPMENT PLATFORM.
WE ALSO HOPE YOU ENGAGE IN THE
SHOWCASE AND WITNESS PROJECTS
THAT ARE TECHNICALLY DERISK AND
READY AND READY TO ADVANCE TO
LATER STAGES OF
PRE-COMMERCIALIZATION AND ENGAGE
WITH INNOVATORS FOR POTENTIAL
PARTNERSHIPS OR INVEST STUNTS.
WE HOPE YOU NETWORK AND CONNECT
WITH STAKEHOLDERS AND ALL THE
PEOPLE HERE TODAY.
AGAIN, THIS EVENT AIMS TO FOSTER
COLLABORATIVE DISCUSSIONS.
YOU'LL HEAR PARTNERSHIPS SEVERAL
TIMES DURING THE MEETING.
WE LOOK FORWARD TO AN ENRICHING
CONFERENCE WHERE IDEAS CONVERGE,
PARTNERSHIPS, FLOURISH AND THE
FUTURE OF POINT OF CARE
TECHNOLOGIES TAKE BOLD STEPS
FORWARD.
WE WELCOME YOU TO THIS
TRANSFORMATIVE EXPERIENCE AND
NOW I'LL TURN IT MY INSTITUTE
DIRECTOR AND OUR FEARLESS LEADER
DR. TROMBERG WITH THOUGHTS ON
POINT-OF-CARE INNOVATIONS AND
APPLICATIONS.
THANK YOU.
>> IF I COULD GET MY SLIDES UP.
I'M NOT GOING TO STAND HERE TOO
LONG.
I'M GOING INTRODUCE OUR KEY NOTE
SPEAKER.
WELCOME HERE AS THE SLIDES ARE
COMING IT'S WONDERFUL TO HAVE
YOU ALL HERE.
I FEEL LIKE THIS IS MORE OF A
FAMILY REUNION CELEBRATION THAN
A SCIENTIFIC CONFERENCE.
IT'S GREAT TO SEE MANY OF YOU.
I HAVEN'T SEEN SEVERAL OF YOU IN
PERSON THOUGH WE'VE BEEN WORKING
TOGETHER FOR YEARS AND IT'S GOOD
TO SEE SEVERAL PEOPLE THAT I
HAVEN'T SEEN IN SUCH A LONG
TIME.
WELCOME.
IT'S ALSO A LITTLE BIT OF MAYBE
I DON'T KNOW WE'RE ALL DEVOTEES
AND TRUE BELIEVERS IN POINT OF
CARE TECHNOLOGY.
IT'S A LITTLE BIT OF A --
THERE'S A BIT OF RELIGIOUSITY TO
THE GROUP WHICH I'M PROUD TO BE
PART OF.
WELL, A SLIDE IS NOT THAT
NECESSARY TO INTRODUCE AND
EXCITED AND PROUD TO BE ABLE TO
HAVE THE 17th NIH DIRECTOR WITH
US, DR. MONICA BERTAGNOLLI.
SHE IS ONLY ON THE JOB FOR 20
DAYS NOW.
AND HAS SIMULTANEOUS MULTIPLE
MEETINGS GOING ON AT THIS MOMENT
AND WILL JUST BE WITH US FOR A
SHORT TIME WHICH WE'RE VERY
APPRECIATIVE OF.
WE TRIED TO PUT HER DIGITAL TWIN
TOGETHER BUT IT DIDN'T -- LIKE
THE TECHNOLOGY IT'S NOT QUITE
READY YET SO WE'RE DEPENDENT ON
YOU FOR ALL OF THAT.
DR. BERTAGNOLLI RECENTLY WENT
THROUGH A CONFIRMATION HEARING
AND I HAVE A LITTLE BIT -- I
HAVE A VISUAL AND I'LL GO INTO
THAT IN JUST A MOMENT.
HER BACKGROUND, SHE WAS
PREVIOUSLY THE DIRECTOR OF THE
NATIONAL CANCER INSTITUTE AND I
THINK ALL OF YOU ARE FAMILIAR
WITH HER CAREER AS A SURGEON AND
PROFESSOR OF SURGERY AT HARVARD
MEDICAL SCHOOL.
SURGERY AT BRIGHAM, A MEMBER OF
DANA FARER.
A LONG AND DISTINGUISHED CAREER
OVER 30 YEARS AS A SURGICAL
ONCOLOGIST.
I HAVE A LETTER FROM OVER 120
PROFESSIONAL ORGANIZATIONS.
I'D LIKE TO QUOTE FROM IT.
YOU CAN GO INTO A PERSON'S
BACKGROUND BUT WHEN YOU GET A
LETTER THAT DESCRIBES HOW WELL
SUITED AND FIT THEY ARE FOR
BEING NIH DIRECTOR I'M JUST
GOING TO READ A LITTLE BIT OF
THAT LANGUAGE IF WE EVER GET THE
LETTER UP.
THERE WAS THIS OUTPOURING OF
SUPPORT FROM ACROSS OUR
COMMUNITY AND THE ENTIRE
SCIENTIFIC COMMUNITY WHICH WAS
GRATIFYING TO SEE.
IT'S CONDENSED AND EXPRESSED IN
THIS LETTER.
AND IN ADDITION TO THAT SHE HAS
AN ENORMOUS BACKGROUND AND
CAPACITY FOR BEING PERSONAL,
ENTHUSIASTIC AND MAKING
CONNECTIONS WITH BOTH SIDES OF
THE AISLE WHICH IS AN EXTREMELY
IMPORTANT SKILL.
THIS BECAME APPARENT IN HER
CONFIRMATION HEARING.
IF YOU TAKE A LOOK AT THAT IN C
SPAN.
YOU'RE INSIDE THE BELTWAY SO
IT'S OKAY TO WATCH ESPECIALLY
RERUNS BUT YOU CAN GET A SENSE
OF HER POISE AND ABILITY TO MAKE
THOSE CONNECTIONS WITH PEOPLE.
IT WAS A TWO-HOUR GRILLING BY
ALL THE SENATORS AND I THINK
MANY OF YOU HAVE SEEN EXCERPTS
OF THESE.
IT'S REMARKABLE HOW MUCH
INFORMATION SHE WAS ABLE TO
CONVEY AND HOW HER CORE
PERSONALITY CAME THROUGH AND
IMPRESSIVE HOW CERTAIN QUESTIONS
SHE RESISTED ANSWERING.
YOU GET THE SENSE THAT SOME OF
THOSE QUESTIONS WERE NOT THE
MOST IMPORTANT OR SCIENTIFIC
QUESTIONS.
SHE HAD A WONDERFUL SENSE OF HOW
TO NAVIGATE THROUGH THOSE.
SO I'M TALKING THROUGH MY ENTIRE
SLIDE NOW.
YOU PROBABLY DON'T NEED TO SEE
IT WITH A PICTURE OF HER BUT THE
LAST THING I WANT TO SAY THAT IN
PARTICULAR -- SHE WAS GRILLED --
YOU CAN READ ABOUT IT IN NATURE.
HERE'S THIS WONDERFUL LETTER
FROM 120 SIGNED BY EVERY
NONPROFIT ORGANIZATION REALLY
THE MOST IMPORTANT POINTING OUT
HER EXCEPTIONAL SKILLS AND
COMPASSION AND ABILITY TO LEAD
US AS THE NEXT NIH DIRECTOR.
WHAT'S MOST IMPORTANT IS THAT
SHE WAS IN UNDERGRADUATE
CHEMICAL ENGINEERING.
SHE WAS AT PRINCETON, SHE DID
HER UNDERGRADUATE RESEARCH ON
SOLUTE TRANSFER ON SEMI
PERMEABLE MEMBRANES AND HER
FAVORITE EQUATION.
MONICA IS USED TO PRESSURE,
VELOCITY AND KNOWS HOW
CONSERVATION OF ENERGY WORKS.
LET'S WELCOME MONICA BERTAGNOLLI
OUR KEY NOTE SPEAKER THIS
MORNING.
>> THANK YOU, EVERYONE.
I'M SO DELIGHTED TO BE HERE.
I WISH I COULD STAY ALL DAY
BECAUSE THIS IS CLEARLY GOING TO
BE EXCITING AND MANY THINGS YOU
DO ARE THE THINGS I I LOVE MOST.
I HAVE TO SAY THIS IS ONE OF THE
FIRST INVITATIONS I ACCEPTED
SINCE BECOMING NIH DIRECTOR NOT
QUITE THREE WEEKS AGO AND WANTED
TO COME HERE TODAY BECAUSE YOU
ALL DESERVE SO MUCH CREDIT FOR
THE POINT-OF-CARE TECHNOLOGY
RESEARCH NETWORK.
IT PLAYED A KEY ROLE IN OUR
RESPONSE TO COVID.
I THINK EVERYONE KNOWS ABOUT
THIS TEAM BECAUSE OF THAT.
IT'S A SPECIAL ACCOMPLISHMENT
WITH NIH FUNDING TRANSLATES SO
QUICKLY AND CAPABLY PUTTING
PRODUCTS IN PEOPLE'S HOLDS.
PRODUCTS THAT HELP THEM FEEL
BETTER PREPARED TO SAFEGUARD
THEIR HEALTH AND THE HEALTH OF
THOSE AROUND THEM.
THAT KIND OF RESEARCH REACH IS
WHAT PROCTORED PROMISES.
THE NETWORK PLAYS A CRITICAL
ROLE NOT ONLY IN EMERGENCIES BUT
IN MOVING THE PROMISE OF NIH
RESEARCH INTO PEOPLE'S LIVES ON
MULTIPLE FRONTS.
THOSE OF US IN THIS ROOM CAN
IMAGINE A DAY WHEN THIS NETWORK
WILL BE RESPONSIBLE FOR OVER THE
COUNTER AND POINT-OF-CARE TESTS
FOR SO MANY DIFFERENT
CONDITIONS.
TESTS FOR MATERNAL HEALTH, FETAL
METABOLIC SEIZES AND HEPATITIS C
AND NEUROLOGICAL CONDITIONS.
YOU ALL IN THE ROOM KNOW WE ARE
NOT FAR OFF FROM SEEING THIS
RESULTING FROM YOUR GREAT WORK.
I WAS AN ENGINEERING MAJOR AND
BEEN DRAWN TO THE PROMISE OF
BUILDING THINGS THAT MAKE
PEOPLE'S LIVES BETTER.
THE PROMISE OF TECHNOLOGY TO
REALLY CHANGE THE WORLD AS WE
ARE SEEING LITERALLY EVERY DAY.
OUR JOB IS ONLY DONE WHEN OUR
DISCOVERIES HELP PEOPLE LIVE
LONG AND HEALTHY LIVES WHEN THEY
TOUCH INDIVIDUAL PEOPLE.
AND YOU ALSO PUT INTO PRACTICE
BETTER THAN REALLY ANYTHING I
CAN POINT TO RIGHT NOW ONE OF
ANOTHER MAIN GOAL FOR NIH THAT
OUR WORK ENGAGE AND HELP EVERY
SINGLE COMMUNITY.
IT IS ESSENTIAL OUR WORK REACHES
PEOPLE NO MATTER WHERE THEY
LIVE.
WE MUTT BRING EVERY COMMUNITY
INTO READINESS WHETHER THAT
MEANS BEING PREPARED FOR A
PANDEMIC OR CONDUCTING RESEARCH
LOOKING FOR WAYS TO HELP PEOPLE
TAKE THE STEPS REQUIRED TO LEAD
HEALTHIER LIVES.
LIKE SO MUCH ABOUT OUR RESPONSE
TO COVID WE NEVER WOULD HAVE
BEEN ABLE TO REACT AS WELL AS WE
DID WITHOUT HAVING LAID THE
SOLID FOUNDATION MANY YEARS
BEFORE.
THIS NETWORK WAS IN ITS THIRD
FIVE-YEAR CYCLE WHEN COVID
EMERGED.
GIVEN THE NETWORK'S STELLAR
RESPONSE TO THE CRISIS, NO
WONDER THAT IN 2023 NIH RENEWED
THE PROGRAM WITH MORE GRANT
RECIPIENTS THAN IN ANY PREVIOUS
CYCLE.
THE SEVEN AWARD RECIPIENTS IN
THE FOURTH CYCLE FOCUS ON
EVERYTHING FROM ENGINEERING
MICROSYSTEMS TO DEVELOPING TESTS
THAT DETECT INFECTIONS LIKE
STDs, IMPROVE THE DIAGNOSIS AND
MANAGEMENT OF HEART, LUNG, BLOOD
AND SLEEP DISORDERS.
SCREEN FOR CANCER AND ADDRESS
NUTRITION, INFECTION AND CANCER
IN AND ESPECIALLY VULNERABLE
POPULATIONS IN THE UNITED STATES
AND GLOBALLY.
IT'S MUCH MORE THAN A NETWORK AS
BRUCE ALLUDED TO IT'S MORE LIKE
A MULTI-DISCIPLINARY ECO SYSTEM
WHERE NIH-FUNDED ACADEMIC
CENTERS WORK WITH MULTIPLE
GOVERNMENT AGENCIES FROM BARDA
TO THE WHITE HOUSE.
OTHER ACADEMIC INSTITUTIONS AND
OF COURSE INDUSTRY.
EACH CENTER SUPPORTS
COLLABORATION AMONG PHYSICAL,
BIO CHEMICAL AND COMPUTATIONAL
SCIENTISTS AS WELL AS
ENGINEERING ON EXPLORE TRY
PROJECTS.
EACH CENTER CONDUCTS IN-HOUSE
CLINICAL TESTS OF PROTOTYPE
DEVICES AND PROVIDES TRAINING TO
TECHNOLOGY DEVELOPERS ON
CLINICAL ISSUES RELATED TO THE
POINT-OF-CARE DEVICES THEY WORK
ON.
ONE OF THE AREAS THAT'S BEEN THE
MAIN FOCUS OF MY CAREER HAS BEEN
THE IMPLEMENTATION OF CLINICAL
RESEARCH THROUGH RIGOROUS
CLINICAL TRIALS AND INCREASINGLY
THROUGH THE TECHNOLOGIES THAT
ARE GOING TO ALLOW US TO GATHER
DATA FROM EVERY PERSON AND
GATHER DATA FROM EVERY
COMMUNITY.
I ALSO KNOW THAT MANY OF THE
THINGS THAT ARE BEING DEVELOPED
WILL BE CRITICAL IN MOVING THAT
FORWARD.
WHEN COVID HIT THIS COMMUNITY
CAME TOGETHER TO STAND UP RADX
AS SOON AS IT BECAME CLEAR THERE
WAS NO WAY TO COMBAT THE NOVEL
CORONAVIRUS WITHOUT ADEQUATE
TESTING AND RADX LAUNCHED.
BY FALL OF 2020, SIX MONTHS
LATER, RADX WAS ABLE TO GET TENS
OF MILLIONS OF TESTS PER MONTH
OUT FOR PEOPLE TO USE.
NOW IN LATE NOVEMBER 2023 THE
FDA AUTHORIZED 55 DIFFERENT
COVID TESTS 7 BILLION TESTS HAVE
BEEN TURNED OUT AND THIS WILL
HELP THOSE DISPROPORTIONATELY
AFFECTED BY OR AT GREATER RISK
OF COVID-19 AND TESTS ACCESSIBLE
TO PEOPLE WITH DISABILITIES.
THIS SUCCESS IS HIGHLY VISIBLE
TO EVERYONE BUT I KNOW THIS IS
ONLY ONE ASPECT OF THE WORK.
CONLATGRATULATIONS FOR WHAT YOU
HAVE ACCOMPLISHED AND WE'RE
EXCITED TO SEE WHAT'S COMING
NEXT.
DESPITE THE AMAZING WORK YOU
HAVE DONE I'M MOST EXCITED ABOUT
WHAT YOU WILL DO NEXT NO MATTER
WHAT.
ALL OF US MUST CENTER ON
PEOPLE'S NEEDS.
THIS NETWORK HAS BEEN A STAND
OUT PROGRAM BECAUSE OF ITS REACH
WORKING WITH EVERYONE WHO MUST
BE INVOLVED IN ORDER TO ENGAGE
WITH COMMUNITIES WHERE EVER.
I'LL GIVE YOU ONE EXAMPLE OF
WHERE I KNOW FIRST HAND THE
CAPABILITIES.
I SAW HOW RADX DELIVERED TESTING
SERVICES TO WYOMING AT THE WIND
RIVER INDIAN RESERVATION WHERE
THE NEAREST FULL-SERVICE
HOSPITAL WAS A HUNDRED MILES
AWAY.
THIS REQUIRED UNDERSTANDING AND
ADDRESSING THE NEEDS OF A UNIQUE
AND REMOTE COMMUNITY.
I KNOW YOUR WORK SAVED LIVED AND
I KNOW THIS IS ONLY ONE OF
COUNTLESS EXAMPLES OF THIS.
AND THIS IS CHANGING THE QUALITY
OF CARE PATIENTS RECEIVE.
YOUR TECHNOLOGIES AND
PARTNERSHIPS HELP MEET PEOPLE
WHERE THEY LIVE INCLUDING IN
THEIR OWN HOMES DELIVERING WHAT
THEY NEED TO LIVE LONG AND
HEALTHY LIVES.
I LOOK FORWARD TO ALL YOU WILL
ACCOMPLISH AND I REALLY HOPE YOU
ALL ENJOY THESE TWO DAYS OF
MEETING.
THANK YOU SO MUCH.
A FEW QUESTIONS IF ANYONE WANTS.
DON'T BE SHY.
TRADITIONALLY, WELL, THAT'S NOT
THE WAY TO SAY IT.
IN THE RECENT PAST, LET'S SAY,
THE FUNDING FOR TECHNOLOGY HAS
FELT TO BE IN AREAS OTHER THAN
NIH.
I THINK THE IMMEDIACY OF
TECHNOLOGY AND IMMEDIATE
APPLICATIONS TO THE KIND OF WORK
NIH HAS DONE HAVE NOT BEEN AS
READILY APPARENT.
BOY, IT CERTAINLY IS NOW.
AND I THINK WHEN TECHNOLOGY
STARTS TO DIRECTLY AND TANGIBLY
ADDRESS NEEDS IN INDIVIDUAL
PEOPLE'S HEALTH AS WHAT POCTRN
IS DOING AND IT BECOMES EASIER
TO DIRECT RESOURCES IN THAT
DIRECTION.
ANYBODY KNOWS TECHNOLOGY IS CORE
TO HEALTH.
WE LIVE IN AN ENVIRONMENT OF
MEDICAL CARE THAT IS GROUNDED IB
IN MORE THAN 150 YEARS OF
TECHNOLOGY DEVELOPMENT BUT AGAIN
IF PEOPLE ASSUME IT'S THERE AND
ASSUME IT WILL BE THERE WHEN
THEY GO TO THE DOCTOR'S OFFICE.
IT'S MAKING TA FROM A BUILT FOR
THE MEDICAL ESTABLISHMENT TO
SOMETHING THAT MATTERS
INDIVIDUALLY TO EVERY PERSON
IMMEDIATELY.
I THINK THAT WAS SEEN IN THE
FUNDAMENTAL DIFFERENCE OF WHAT
THE GROUP DOES.
I THINK WE'LL SEE BIG CHANGES
WITH THAT.
THIS IS A TIME WHEN THE IMPACT
OF THE NETWORK ON SCIENCE IS
REALLY CLEAR ALSO A TIME WHEN A
LOT OF THE PUBLIC HAS MAYBE LOST
CONFIDENCE DO YOU HAVE ADVICE
FOR HOW THE NETWORK SHOULD
APPROACH ITS WORK GOING FORWARD
SO PEOPLE WANT TO TAKE ADVANTAGE
OF THE BENEFITS OF THAT NEW
PROGRESS?
>> I THINK YOUR WORK IS -- IF I
HAD TO POINT TO SOMETHING ACROSS
NIH THAT'S DOING THE MOST
TOWARDS THIS END IT WOULD
SOMETHING LIKE POCTRN.
WHY IN WHAT WE NEED IS TO TRULY
ENGAGE PEOPLE A VERY DIVERSE
RANGE OF PEOPLE IN OUR RESEARCH.
WE NEED TO HAVE EVERYONE
UNDERSTAND WE'RE ADDRESSING
PEOPLE'S NEEDS AND WE'RE
ACCOUNTABLE TO THEM AND
TRANSPARENT AND THE BEST WAY TO
DO THAT IS TO DIRECTLY ENGAGE
THEM IN RESEARCH.
ONE OF MY MANTRAS YOU'LL
PROBABLY HEAR IT A LOT IS THE
ONE THAT COMES FROM THE PATIENT
ADVOCACY COMMUNITY NOTHING ABOUT
US WITHOUT US AND BY NATURE THE
WORK HAS TO DIRECTLY ENGAGE WITH
PEOPLE TO BE POSSIBLE AND WHY
CLINICAL TRIALS ARE IMPORTANT TO
ENDEND ER -- ENGENDER TRUST AN
REBUILD WITH THE COMMUNITY AND
KEEP DOING WHAT YOU'RE DOING AND
COMMUNICATE IT WELL AND HAVE
EVERYONE INVOLVED.
THAT'S ANOTHER BENEFIT OF THIS
PARTICULAR GROUP.
>> IS THERE SOMETHING THAT YOU
SEE THE NIH MISSION IS GOING TO
BE?
>> YOU'VE ASKED THAT QUESTION
TWO DAYS TOO EARLY.
WHAT WE'RE GOING TO DO -- WHAT
I'M GOING TO DID -- I'LL TELL
YOU WHY I WANTED TO BE NIH
DIRECTOR.
I'VE HAD AN AMAZING -- I'VE BEEN
SO FORTUNATE IN MY CAREER TO
WORK WITH INCREDIBLE PEOPLE AND
I WANTED TO BE NIH DIRECTOR
BECAUSE THIS IS AN ORGANIZATION
OF 27 INSTITUTES OF THE BIGGER
AGENCY OF HEALTH AND HUMAN
SERVICES AND THESE ARE
UNBELIEVABLE PEOPLE WHO HAVE A
BEAT ON HOW TO IMPROVE THE
WORLD.
IN ANSWER TO YOUR QUESTION, THE
WHOLE REASON I'M HONORED TO RUN
NIH IS THE PEOPLE WHO SIT AROUND
THE TABLE AT THE DIRECTORS'
MEETING AND WHAT WE'LL DO ON
THURSDAY IS SIT DOWN, ALL 29 OF
US AND WE NOW HAVE AN AGENCY,
ARPA-H AND WE 27 INSTITUTES AND
ONE AGENCY ARPA-H AND ONE
DIRECTOR, ALL 29 OF US WILL SIT
DOWN ON THURSDAY AND DECIDE WHAT
OUR PRIORITIES ARE GOING TO BE
FOR NIH FOR THE FORESEEABLE
FUTURE.
I CAN TELL YOU THE WORK OF
POCTRN WILL BE INVOLVED AND I'LL
HEAR ABOUT THIS SOON.
>> ONE OF THE IMPLICATIONS IS
CAPTURING THE LIVED EXPERIENCE
OF FOLKS AT HOME AND YET WHEN WE
GENERATE THIS DATA IN THE
CONDUCT OF SCIENCE SEEMS THE
GOLD STANDARD WANTS TO HAVE
FORMATIVE COMPARISONS AND
DIFFERENT TESTS IN ACCEPTING
THIS DISPARATE DATA.
IT'S A CONSEQUENCE OF THESE
TECHNOLOGIES.
>> TOUGH ONE.
IT'S THE SAME THROUGHOUT ALL OF
CLINICAL RESEARCH.
WHAT BEST ACHIEVE THE NEEDS OF
THE PATIENT IS WE HAVE TO
DELIVER THE SYSTEMS.
THINK ABOUT HOW WE MEASURE BLOOD
PRESSURE TODAY AND WHAT'S
HAPPENED TODAY.
THINK OF ALL THE CARDIOVASCULAR
TRIALS DEVELOPED USING THAT
REALLY LUM SI AND INACCURATE
MEASURE OF MEASURING BLOOD
PRESSURE.
WE CAN DO BETTER.
AS WE DO BETTER, WHEN THINGS ARE
TESTED AND SHOW THEY ARE MORE
RELIABLE AND MORE ABLE TO
DELIVER WHAT PATIENTS NEED, GAME
OVER.
YOU'RE DONE.
I THINK WE ALL NEED TO ADOPT
THAT STANDARD.
NO MATTER WHAT WE PRODUCE WE
HAVE TO PRODUCE BETTER THAT'S
WHAT'S THERE TODAY AND BETTER
MEET THE NEEDS OF THE PATIENT
AND THE DOCTOR TO MAKE DECISIONS
THAT GUIDE BETTER CARE.
AS IT NOT EASY AND ANOTHER THING
THAT IS GOING TO HELP THIS A LOT
IS BROAD SHARING OF DATA.
SO WE KNOW -- WE DON'T HAVE TO
REINVENT EVERYTHING.
WE KNOW HOW TO COMPARE THE PAST
TO THE PRESENT VERY CAREFULLY.
WE CAN DO MANY MORE IN SILICO
TRIALS IF THAT HELPS.
ONE MORE.
I DON'T WANT TO USURP YOUR WHOLE
MEETING HERE.
THIS IS GREAT.
>> ONE OF THE THINGS THAT MADE
THE RADX POCTRN EXPERIENCES WAS
SO IMPACTFUL AND EFFECTIVE WAS
THE COLLABORATION WITH OUR
SISTER AGENCIES, FDA AND CMS.
AS YOU ENTER THIS POSITION, IF
YOU CAN DESCRIBE HOW TO KEEP
THAT IMPACTFUL WILL BE USEFUL.
I WORK IN THE OER AND I WOULD
LOVE TO HELP BE PART OF THAT
INITIATIVE IF YOU CHOOSE TO GO
THERE.
THANK YOU.
>> THANK YOU SO MUCH FOR THAT.
I TOLD YOU THERE WERE TWO
REASONS WHY I WAS SO THRILLED TO
BE ASSUMING THIS POSITION.
NUMBER ONE WAS THE 28 PEOPLE
SITTING AROUND THE PEOPLE AT THE
DIRECTORS FOR NIH, THE OTHER IS
THE OPPORTUNITY TO WORK WITH
THAT AND THE INCREDIBLE BREADTH
AND DEPTH OF HHS.
OUR SISTER AGENCIES HAVE LEADERS
THAT REALLY DO EMBRACE THIS GOAL
OF WORKING TOGETHER.
MAYBE IT WAS COVID.
I SUSPECT IT'S ALSO THE RIGHT
KIND OF PEOPLE THAT WENT TO SEE
THIS AS A MISSION.
AND WE'RE ALREADY DOING THAT
ACTIVELY.
THANK YOU FOR THAT.
IT'S CRITICALLY IMPORTANT AND WE
CAN DO MORE IF WE ADOPT THAT
POLICY, THAT APPROACH.
TIME FOR UP WITH MORE, BRUCE?
>> A QUICK ONE?
>> SO, I'M FROM PUBLIC HEALTH
AND A LAB DIRECTOR DURING THE
PANDEMIC IN NEW YORK.
I'M A TRUE BELIEVER AS BRUCE
SAID IN POINT-OF-CARE AND HOME
USE BECAUSE I THINK IT WILL
FUNDAMENTALLY CHANGE THE WAY WE
DO PUBLIC HEALTH.
I'M INCREDIBLY EXCITED.
I DON'T SEE PUBLIC HEALTH ON THE
AGENDA THE NEXT TWO WEEKS AND
FOR REGULATORS AND
MANUFACTURERS, I HOPE YOU KEEP
PUBLIC HEALTH IN MIND WHERE THE
TRADITIONAL FIRST RESPONDERS,
DID WE DO SO WELL LAST TIME?
I THINK WE CAN DO BETTER AND
THINK THE TOOLS WILL ALLOW US TO
DO BETTER.
>> THANK YOU AND I'LL REMIND
EVERYBODY THAT NIH SCOPE GOES
FROM FUNDAMENTAL SCIENCE THROUGH
CARE DELIVERY ACHIEVE THE
RESULTS WE NEED.
PUBLIC HEALTH IS IS WITHIN THE
THINGS YOU'RE TALKING ABOUT IS
VERY MUCH -- HOW TO DELIVER AWE
KNOW WORKS IS JUST AS MUCH AS
SUCH AS IMPORTANT PART OF OUR
RESEARCH AS THE FUNDAMENTAL
SCIENCE.
IT DOESN'T MATTER WHAT WE DO IN
THE LABORATORY IF IT DOESN'T
HELP A PERSON OR GET US TO THE
IMPORTANT WHO NEEDS IT.
I AGREE ENTIRELY AND IT'S PART
OF WHAT WE DO.
THANK YOU EVERYTHING AND HAVE A
GREAT MEETING.
>> THANK YOU, MONICA.
>> MANY THANKS TO
DR. BERTAGNOLLI.
THE QUESTIONS WERE OUTSTANDING
AND HOPE TO TOUCH ON THE THEMES.
THE LAST QUESTION ON PUBLIC
HEALTH AS A RESULT OF THIS
EXPERIENCE THE MOST IMPORTANT
CONTRIBUTION WE CAN MAKE AS A
COMMUNITY IS TO THROUGH TRAINING
AND EDUCATION OF OUR BIO MEDICAL
ENGINEERS TO MOVE THEM INTO
PUBLIC HEALTH.
IT'S NOT TRADITIONALLY BEEN AN
AREA OF FOCUS FOR BIOMEDICAL
ENGINEERING STUDENTS AND
TRAINEES BUT NEEDED AND MAGICAL
THINGS CAN HAPPEN AS WE EXPAND
OUR ENGAGEMENT WITH MENTAL
HEALTH AS WE'VE SEEN IN THE
PANDEMIC.
SO LET'S SEE IF I CAN GET MY
NEXT SLIDE.
I MAY NEED TECHNOLOGY ASS
ASSISTANCE.
I THINK IT'S JUST ME.
DO I JUST HIT AN ARROW?
CAN I GET REMEDIAL INSTRUCTION?
I CAN'T SEE THE MONITOR.
SO I'M NOT ACTUALLY RUNNING.
YOU THINK YOU'RE IN CONTROL BUT
YOU'RE REALLY NOT.
THE SLIDE I WAS LOOKING FOR.
OKAY.
I WANTED TO TAKE A MOMENT AND
THANK OUR ORGANIZERS, ESPECIALLY
DR. LASH WHO PRNURTURED THIS FR
THE BEGINNING RECENTLY THE
NETWORK HAD RENEWED AND TIFFANI
STARTED IT OFF AGAIN AND THIS
NETWORK DROVE US THROUGH THE
COVID PANDEMIC AND NOW IT'S
EXPANDED WITH TWO MORE SITES AND
WE'RE PLEASED ABOUT THAT.
TIFFANI AND AUTUMN CO-CHAIRED
THIS.
AS DR. BERTAGNOLLI ALLUDED TO,
WE CAN'T MAKE THINGS WORK
WITHOUT PARTNERSHIPS.
THIS IS ONE OF THE MOST
SPECTACULAR PARTNERSHIPS AT THE
NIH.
YOU SEE ALL THE MULTIPLE
PARTICIPATING AGENCIES.
ALL OF OUR PROGRAM AND REVIEW
STAFF AND HIGHER STAFF AT THE
NIBIB ARE ALL ENGAGED IN THE
NETWORK IN SOME KIND OF WAY.
AND RELEVANT TO THE PUBLIC
HEALTH COMMENT AND SEVERAL OF
THE OTHER QUESTIONS THAT CAME
UP, NIBIB IS UNIQUE IN THAT
WE'RE OBSESSED WITH THE DATA
SOURCES AND INSTRUMENTS AND
GETTING CONCEPTS AND IDEAS FROM
THE CONCEPTUAL STAGE AND BENCH
TALK AND MOVE IT INTO FULLY
DISSEMINATED MANUFACTURED
DEVICES THAT IMPACT PUBLIC
HEALTH.
TO UNDERSTAND THAT YOU NEED TO
UNDERSTAND THE CREATION STORY.
I SAID THIS WAS A LITTLE BIT OF
A RELIGIOUS GATHERING AND WE
HAVE A CREATION STORY BACK TO
CONGRESS IN 2000 THAT PULLS OUT
THE LANGUAGE AND UNDER SCORES
TECHNOLOGY, BIOMEDICAL IMAGING
AND BIO ENGINEERING AND RELATED
TECHNOLOGIES NEED A HOME AT THE
NIH.
AT THAT TIME THROUGHOUT THE '90s
THERE WAS NO HOME.
THE GENERAL IMPRESSION OF NIH
WAS COOL RESEARCH AND BIOLOGY
WAS GOING ON.
ZEBRAFISH WAS A COMMON PLATFORM
TO BE USED IN RESEARCH BUT NOT
SO FRIENDLY TO THE DEVELOPMENT
OF NEW TECHNOLOGIES.
AFTER A DECADE OF STRUGGLE,
MULTIPLE PROFESSIONAL SOCIETIES
COMING TOGETHER FROM THE IMAGING
AND NEENKI IING -- AND ENGINEEG
AND NIBIB AND THERE'S BEEN
REMARKABLE GROWTH IN BIO
ENGINEERING AROUND THE COUNTRY.
AND UNDERGRADUATE DEPARTMENTS
OVER 200 GRADUATE PROGRAMS.
YOU SEE THE INFLEXION POINT
TAKING PLACE.
A LOT OF THIS HAS BEEN DRIVEN,
THE FOUNDATION SET FROM THE
WHITAKER FOUNDATION PUTTING
AROUND $760 MILLION INTO
BIOMEDICAL ENGINEERING AND
DEPARTMENTS.
MANY HAVE BEEN THE
BENEFICIARIES.
I HAVE BEEN A BENEFICIARY OF
THAT IN THE FORMATION AND GROWTH
OF A DEPARTMENT THAT I JUST WENT
BACK FOR THE 20th REUNION.
THERE'S 800 STUDENT
UNDERGRADUATE GRADUATE STUDENTS.
WE HAD NO IDEA ANY OF THIS WOULD
HAPPEN.
MULTIPLY THAT BY MANY ORDERS
AROUND THE COUNTRY AND YOU SEE
THIS INCREDIBLE MULTIPLICATIVE
EFFECT AND IT'S QUITE A
TRANSFORMATION.
WHAT DO WE DO AT NIBIB.
THIS IS OUR ICONOGRAPHY AT WHAT
WE DO TO SUPPORT OUR COMMUNITY.
WE SUPPORT THINGS LIKE
ENGINEERED BIOLOGY.
FROM SYNTHETIC TO
MICROPHYSIOLOGIC SYSTEMS AND
EVERYTHING IN BETWEEN AND
REPROGRAMMING SINGLE CELLS AND
ORGANOIDS AND TRANSDUCING
ENERGY, ACOUSTIC, THERMAL,
CHEMICAL, PLATONIC, ALL SORTS OF
WEARABLE AND IMPLANTABLE AND
MOVING THEM TO POINT OF CARE AND
BIG PHYSIC DEVICE TO PORTABLE
BEDSIDE AND THERAPEUTIC SYSTEMS
MINIMALLY AND NON-INVASIVE
ENERGY DELIVERY AND ACTIVATION
OF MOLECULES SPECIFICALLY AS
WELL AS ROBOTICS AND ROBOTIC
ASSISTED DEVICES AND EVERYTHING
IS BROUGHT TOGETHER BY
COMPUTATIONAL TECHNIQUE.
SO DATA SCIENCE, MODELLING,
COMPUTATION, THEY'RE AT THE CORE
OF EVERYTHING WE DO ALL THOSE
TECHNOLOGIES INVOLVE DESIGN BY
DATA SCIENCE AND MODELLING AND
EXTRACTION OF GREATER
INFORMATION CONTENT WITH NEW
INSIGHTS BY LOOKING AT HOW THAT
MODEL MAY COMPARE WITH
EXPERIMENTAL DATA THAT'S DERIVED
FROM A PARTICULAR SYSTEM.
THE CORE PROGRAMS AT NIBIB AND
ALL OF NIH HAVE BEEN
DRAMATICALLY IMPACTED AND
TRANSFORMED BY THE PANDEMIC.
THIS IS MY SIMPLE ENGINEERING
DIAGRAM TO ILLUSTRATE THAT WE
TOOK OUR CORE PROGRAMS, THE NIH
DIRECTOR WAS REALLY AWARE OF OUR
CAPABILITIES IN ALL OF THESE
AREAS AND WE HAD AN OPPORTUNITY
TO BRING OUR EXPERTISE IN
IMAGING AND ARTIFICIAL
INTELLIGENCE AND DIGITAL
PLATFORMS DURING THE PANDEMIC TO
BEAR ON TO SOLUTIONS AND CREATED
TWO FLAGSHIP PROGRAMS WITH THOSE
NEW RESOURCES.
ONE IS RADX FOR RAPID ACC
ACCELERATION AND THE DATA IMA
IMAGING RESOURCE CENTER A WAY TO
CONSERVE MEDICAL IMAGE DATA AND
INCREASING AND ACCELERATING THE
DEVELOPMENT AND VALIDATION OF
A.I.-BASED ALGORITHMS TO IMPROVE
DIAGNOSTICS AND PROGNOSTICS.
THOSE TWO PRODUCTS, SO TO SPEAK,
OF THE PANDEMIC, FED BACK TOO
THE ETHOS AND THE CULTURE OF
EVERYTHING THAT WE DO AT NIBIB
AND ITS EXTENDED ACROSS THE NIH
AS IMPACTED IN INFLUENCED ALL 27
INSTITUTE CENTERS AND OFFICES.
WHAT ARE THOSE THOSE RADX
PRODUCTS.
I'LL GO INTO DETAIL ON THAT.
AT THE CENTER WAS THE POCTRN
NETWORK AND THERE'S THE
INSTITUTE AT NGH AT THE
ORGANIZING CENTER AND BECAUSE
THE WAY IT'S STRUCTURED WE WERE
ABLE TO DELIVER RESOURCE TO THE
NETWORK WHICH THEN COULD DELIVER
RESOURCES TO ALL OF YOU TO
INVESTIGATORS ALL AROUND THE
COUNT RI.
AND DO IT QUICKLY BECAUSE TIME
WAS OF THE ESSENCE.
WE NEEDED TO BE ABLE TO DELIVER
THE RESOURCES IN WEEKS MIGHT A
MONTH OR TWO MONTHS NOT IN THE
TYPICAL ONE-YEAR TIME FRAME
BECAUSE THE PROBLEM WAS URGENT.
THAT ABILITY IS RESIDUAL NOW.
IT'S EMBEDDED IN OUR SYSTEM AND
WE WORKED OUT THE PROCESS TO DO
THAT NOT JUST IN TIMES OF
NATIONAL EMERGENCY BUT IN TIMES
WHERE WE NEED TO ACCELERATE THE
DEVELOPMENT OF TECHNOLOGIES.
SO TO MAKE THIS HAPPEN, OUR
FIRST PRODUCT WITHIN THE NETWORK
WAS A SHARK TANK OR INNOVATION
TUNNEL TO MOVE THEM THROUGH WITH
MULTIPLE STAGES WHERE
INVESTIGATORS COULD RECEIVE
MONEY OR RESOURCES TO ACCELERATE
AND VALIDATE THE CONCEPTS.
WHAT WAS CRITICAL IN ALL THIS
THE NETWORK PULLED TOGETHER
THREE MAJOR CORES TO GIVE US AN
ABSOLUTE TRUTH.
FIRST AS ALL OF YOU KNOW, EVERY
TECHNOLOGY THAT YOU DEVELOP
RIGHT AT THE BEGINNING WORKS
PERFECTLY IN YOUR MINDS BUT IT
HAS TO GO THROUGH A VALIDATION
CORE TO REALLY SEE, PUT IT
THROUGH ITS FACES AND GET TO A
TRUTH.
EMORY AND GEORGIA TECH U-MASS
BUILT A CORE WITH NOVEL
APPROACHES IN DIGITAL TRIALS AND
THEN A DEPLOYMENT CORE BECAUSE
AFTER YOU GET ALL THESE THINGS
YOU HAVE TO FIGURE OUT ISSUES OF
MANUFACTURING AND SUPPLY WHICH
BECAME HUGELY IMPORTANT DURING
THE PANDEMIC.
EVERYBODY WANTED THE SAME PARTS
AND PIECES AND COMPONENTS.
THIS WAS AN INCREDIBLY IMPORTANT
ELEMENT.
OVER THE COURSE OF THE PANDEMIC
THOUGH WE STARTED WITH A SHARK
TANK WE HAD TO CREATE NEW
PRODUCTS.
BECAUSE ALL THE TIME THERE WERE
NEW CHALLENGES AND I THOUGHT THE
TECHNOLOGY WILL BE THE HARDEST
PART BUT ENDED UP BEING THE
EASIEST PART.
WE HAD LOTS OF CULTURE AND
HUMANS TO DEAL WITH AND CREATED
ADDITIONAL PRODUCTS, DIGITAL
HEALTH PLATFORMS, OUR COVID TEST
PROGRAM AND IN ORDER TO REALLY
BRING TESTING AND UNDERSTAND
WHAT EXPERIENCES WERE AT HOME.
NOBODY HAD DONE TESTING AT THIS
SCALE AT HOME BEFORE.
IT WAS UNHEARD OF.
WOULD IT WORK.
?
VARIANTS CAME UP AND WE HAD
VARIANTS TASK FORCE?
THE BOTTLENECK IS FDA APPROVAL
OR AUTHORIZATION AND WE FORMED A
STRONG COLLABORATIVE
RELATIONSHIP WITH THE IN DEPEND
EPT TEST AT THE SAME TIME
PROGRAM.
WE HAVE A WEB-BASED APP NOW.
HOPEFULLY THIS WON'T BE A SUPER
SPREADER EVENT BUT IF YOU DO GET
COVID GO ON TO MAKE MY TEST
COUNT.org AND TEST ANONYMOUSLY.
WE HAVE A HOME TEST AND TREAT
PROGRAM IN PARTNERSHIP WITH ASPR
AND CDC AND HAVE REALLY ADVANCED
TEST ACCESSIBILITY.
YOU KNOW IT'S HARD TO COUNT THE
DROPS AND OPEN UP THE PACKAGES
IT'S LIKE A CHEMISTRY SET IN
HIGH SCHOOL.
THESE HAVE ADVANCED
SIGNIFICANTLY THROUGH OUR TEST
ACCESSIBILITY PROGRAM.
BOTTOM LINE, THERE'S BEEN
ENORMOUS GROWTH AND EXPANSE IN
THE TESTS WE SUPPORTED OR THE
COMPANIES WE SUPPORTED THEY'VE
INCREASED TESTING CAPACITY BY
NEARLY 8 BILLION TESTS OVER
THREE YEARS AND THE BIG DRIVER
HAVE BEEN THE INDEPENDENT TEST
ASSESSMENT PROGRAM.
GOING BACK TO APRIL OF 2020 YOU
ONLY THOUGHT OF TESTS IN
LABORATORY AND PUBLIC HEALTH WAS
COMFORTABLE WITH THAT.
THEY TOLD US THEY SHOULD BE AND
DOCTORS SHOULD PRESCRIBE TESTS
BUT THERE'S A PARADIGM SHIFT.
IN FEBRUARY OF 2022 ALONE THE
GOVERNMENT DISTRIBUTED WITH LOTS
OF HELP FROM RADX A BILLION OVER
THE COUNTER TESTS.
1.1 BILLION TESTS IN TOTAL AND 1
BILLION OVER THE COUNTER.
2.5 BILLION OVER THE COUNTER
TESTS AND STILL HAVE THOSE TEST
STOCKPILES AND HOPEFULLY STILL
GET DISTRIBUTIONS ON THOSE AND
THE NEW ONES ARE COMING AS WELL.
I DON'T KNOW IF PAM IS HERE BUT
YOU SHOULD TALK TO THEM AND THIS
REDUCED THE TIME TO
AUTHORIZATION THROUGH PROCESS
EFFICIENCIES DRAMATICALLY.
LESS THAN TWO MONTHS WAS THE
RECORD 55 OR 53 DAYS, ERIK CAN
TELL YOU EXACTLY AND MANY STEPS
IN AND PARTNERSHIP FROM THE FDA
AND OCTC7 WAS AN IMPORTANT
PARTNERSHIP.
NOT ONLY WAS THE OUTPUT IN TERMS
OF THE UAs AND TEST CAPACITY
INCREASE WERE DRAMATIC WE
THROUGH CLOSE COLLABORATION
INFLUENCED FDA POLICY AND
THERE'S A NUMBER OF CHANGES THAT
OCCURRED.
I WON'T GO INTO DETAILS.
THE BIGGEST WAS THE SERIAL
TESTING AUTHORIZATION.
THE FULL LABELLING OF TESTS FOR
SERIAL TESTS WHICH CAME AS A
RESULT OF THE YOU MASS STUDIES
THAT SHOWED MULTIPLE TESTS OVER
A PERIOD OF TIME 2 AND 48 HOURS
ARE AS GOOD AS NUCLEIC ACID TEST
AND THIS IS CRITICAL IN
INFORMING THE PUBLIC.
WHEN FDA CHANGED POLICY WITHOUT
TALKING TO US.
FOR EXAMPLE, THEY SENT A NOTICE
WE HAD TO SWITCH FROM NASAL WASH
YOU COULD BUY IT RELATIVELY
INEXPENSIVELY TO NASAL SWAB
MATRIX FOR THE STUDIES, THAT
SENT EVERYONE INTO A TIZZY
BECAUSE THAT STUFF IS $100 PER
MIL.
INCREDIBLY EXPENSIVE AND EMORY
ROLLED UP THEIR SLEEVES.
EVERYONE GAVE NASAL SWAB AT THE
OFFICE AND BASICALLY SIX LITERS
OF NASAL SWAB MATRIX WERE
PRODUCED AND SHOWS THE
COMMITMENT AND DEDICATION OF THE
NETWORK.
THANK YOU, EMORY FOR DOING THIS.
IS THAT SAVED US ABOUT $600,000.
AS I ED -- SAID, HERE'S SOME
PROJECTS ONGOING.
DR. BERTAGNOLLI MENTIONED SOME.
WE HAVE MULTIPLEXED HIGH
PERFORMANCE TESTS AND WE HAVE
STD TESTS, HIV AND VIRAL LOAD
AND HEP C TESTS BEING ADVANCED
AND FETAL MONITORING
TECHNOLOGIES.
NOT JUST INFECTIOUS DISEASES BUT
ALSO A VARIETY OF OTHER PROBLEMS
THAT CAN BE ADDRESSED
POINT-OF-CARE TECHNOLOGIES THAT
ALL OF YOU ARE PASSIONATE ABOUT.
I'LL SHOW QUICK EXAMPLES.
AND THESE ARE THE ABILITY TO
SENSE WHAT'S HAPPENING IN THE
BRAIN THROUGH OPTICAL IMAGING
APPROACHES INTEGRATED INTO A
SINGLE WEARABLE DEVICE.
IT'S BEEN SUPPORTED THROUGH THE
BLUEPRINT MED TECH PROGRAM WHICH
IS A CONSORTIUM OF 12 NIH
CENTERS COMING TOGETHER,
GATHERING AROUND THE CONCEPT
THROUGH SOME VERY PERSUASIVE
PROGRAM DIRECTORS WHO HAVE BEEN
ABLE TO CONVINCE THE NIH CENTERS
IT'S A GOOD WAY TO ADVANCE
TECHNOLOGIES.
ANOTHER ONE SUPPORTED BY THE
HEAL INITIATIVE IS A
NON-INVASIVE, NON-ADDICTIVE
ULTRASOUND TREATMENT FOR
NEUROPATHIC TREATMENT AND
ULTRASOUND AND INDIVIDUALS CAN
DRIVE THIS AT HOME.
WE HAVE THE RADX MATERNAL HEALTH
PROGRAM WITH 10 SEMI FINALISTS
BEING EVALUATED FROM ANEMIA TO
CONTINUOUS BLOOD PRESSURE
MONITORING, HEMORRHAGE AND
RESUSCITATION AND POINT-OF-CARE
UTI DIAGNOSTICS AND MHEALTH,
MENTAL HEALTH EVALUATIONS USING
DIGITAL HEALTH PLATFORMS.
A BEAUTIFUL RANGE OF REALLY
POTENTIALLY VERY EXCITING
TECHNOLOGIES.
THIS IS A TIPPING POINT IN SOME
WAY.
WE'VE GOTTEN THE ATTENTION OF
MANY COMMUNITIES TRADITIONAL
COMMUNITIES WHICH WOULD NOT
NORMALLY GRAVITATE TO
POINT-OF-CARE AND AT-HOME
DIAGNOSTICS.
THEY'RE PAYING ATTENTION.
THE NIH DIRECTOR IS PAYING
ATTENTION AND COLLEAGUES ARE
EXCITED.
THIS IS WHERE I TOSS THE BALL
BACK INTO YOUR COURT.
HERE THE PROJECTIONS WE SEE FROM
INDUSTRY.
CONSUMERS AT HOME AND AT THE
POINT-OF-CARE, THEY'RE THE NEW
TARGETS.
THE NEW MARKET FOR DIAGNOSTICS.
IT'S BOTH A LUCRATIVE MARKET AS
WELL AS AN IMPORTANT AND
COMPELLING PUBLIC HEALTH NEED.
WE'RE SEEING THE CONVERGENCE OF
THE TWO AND THE TECHNOLOGIES
THEMSELVES HAVE MOVED TO A PRICE
POINT WHERE IT'S POSSIBLE THAT
THIS CAN IMPROVE ACCESS AND
OUTCOMES FOR MANY MANY PEOPLE.
SO WE SEE THIS PROJECTED GROWTH.
WE SEE WE'VE INVESTED IN THANK
YOU PLATFORMS WITH THE RADX
PROGRAM THAT CAN BE LEVERAGED
AND WE'VE SEEN A REMARKABLE
EXPANSION OF TELEHEALTH AND THAT
CAN BE BETTER AND DOCTORS CAN
RELY ON VOICE A BIT BUT
ULTIMATELY YOU WANT TO MAKE SOME
MEASUREMENTS WITH A HIGH DEGREE
OF RELIABILITY AND
STANDARDIZATION.
WE CAN EXTEND THIS TO OTHER
PATHOGENS AND CHRONIC DISEASES.
THE BIG CHALLENGE BACK TO ALL OF
YOU, HI IT MANAGE THE EXPLOSION
OF DIAGNOSTICS AND USE THE TESTS
ACCURATELY, REPORT THEM RELIABLY
STANDARDIZE THEM AND INTERPRET
OVERWHELMING NUMBERS LIKE THE
BILLION WE SAW DISTRIBUTES IN
FEBRUARY.
WE'LL STOP THERE AND I DON'T
KNOW IF WE HAVE TIME FOR
QUESTIONS BUT I'M HANGING OUT
AND SCHMOOZING OVER THE NEXT FEW
HOURS.
THANK YOU VERY MUCH.
I THINK ON ZOOM WE'D SAY IF
THERE'S NO FURTHER QUESTIONS.
WE ARE ON ZOOM.
SO I'LL BE AROUND.
THANK YOU ALL VERY MUCH FOR YOUR
WORK AND THANK YOU FOR COMING.
AND I LOOK FORWARD TO CATCHING
UP WITH EVERYONE.
>> SO NOW THE FUN BEGINS WITH
WELL, WE'D LIKE TO THANK SOME
CERTAIN PEOPLE BEFORE WE GET
STARTED INTO THE PROGRAM A
LITTLE FURTHER.
IF YOU ARE PART OF THE
ORGANIZATION TEAM, CAN YOU
PLEASE STAND UP?
SO THERE'S BEEN A LOT OF HARD
WORK IN GETTING EVERYBODY TO
THIS POINT OF THE PROGRAM AND
WE'D LIKE TO THANK THE PEOPLE
PART OF THIS OPERATION HERE.
SO WITHOUT FURTHER ADO, WE'RE
GOING TO GET STARTED WITH OUR
FIRST DISTINGUISHED PANEL.
IT'S LED BY DAVID McMANUS ON POC
TECHNOLOGIES AND PERSPECTIVES
AND CHALLENGES.
IF YOUR PART OF THIS PANEL, CAN
YOU PLEASE COME UP NOW.
>> GOOD MORNING AND WHAT A
WONDERFUL PRIVILEGE IT IS TOON
YOU ON THE CAMPUS TO A GREAT
KICKOFF AND CONNECT WITH PEOPLE.
I'M STRUCK BY MANY THINGS
INCLUDING HOW TALL HE IS AND
THERE'S SEVERAL SESSIONS AND
GIVE THE AUDIENCE PERSPECTIVES
ON DIFFERENT STAKEHOLDER GROUPS.
WE'RE REALLY GRITFUL FOR THE
OPPORTUNITY TO DISCUSS --
GRATEFUL TO FOR THE OPPORTUNITY
TO DISCUSS CLINICAL
PERSPECTIVES.
IT MEANS BOTH NURSING,
PHYSICIAN, MEDICAL ASSISTANT AND
PERSONNEL BOTH PHYSICIANS AND
OTHER GROUPS AND WE PUT TOGETHER
A PANEL TO DISCUSS THAT A LITTLE
BIT FOR A VARIETY OF REASONS
DECIDED TO AVOID SLIDES AND
INSTEAD WE'LL KEEP THIS
CONVERSATIONAL.
I'LL KICK OFF BY ASKING DR. NATE
HEYFUR AND LED AS PART OF OUR
POCTRN NEEDS ASSESSMENT TO
DISCUSS SOME OF THE PERSPECTIVES
THAT THEY'VE ASCERTAINED BACK
FROM PHYSICIANS, NURSES AND
MEDICAL PROFESSIONALS
PARAMEDICS.
WHAT ARE CURRENT PERSPECTIVES ON
THE POSITIVE AND SOME CHALLENGES
AND PLEASE, HELP US KICK OFF
WITH A VARIETY OF PIECES OF
INFORMATION THAT ARE RELEVANT.
THANK YOU.
>> THANK YOU, DAVE AND HAPPY TO
BE HERE TODAY.
AS DAVE MENTIONED ONE OF OUR
CHARGES IS TO REALLY UNDERSTAND
THE NEEDS CLINICIANS AND
PATIENTS AS WE DEVELOP NEW
TECHNOLOGIES.
WE TOOK THAT CHALLENGE HEAD ON
AND HAVE BEEN OVER THE LAST FIVE
YEARS PUTTING OUT ANNUAL CALLS
TO OUR DIFFERENT COMMUNITYIES W
E-MAILED OUT PEOPLE IN THE
AUDIENCE AND OTHER FOLKS TO GET
THEIR PERSPECTIVE.
WE HAD RESPONDENTS FROM NEARLY
ALL 50 STATES HAVE BEEN HAPPY
WITH A BROAD PERSPECTIVE OF
CLINICIANS AND NOT JUST M.D.s
AND ADVANCE PRACTICE NURSES AND
OTHER TYPES OF PEOPLE REALLY
THOSE DELIVERING CARE AND WILL
BE IMPORTANT IN DELIVERING CARE
IN THE FUTURE.
PUSH HEALTH CARE OUT IT PEOPLE
AT THEIR HOMES OR THEIR PHARMACY
OR NON-TRADITIONAL CLINICAL
SITES.
WE'VE DONE THESE SURVEYS A
NUMBER OF YEARS.
WE'VE SEEN THE CHARACTERISTIC OF
THE TECHNOLOGY MOST IMPORTANT
ARE EASE OF USE, NOT DISRUPTING
WORK FLOW INTUITIVE TO USE.
THESE MAY NOT BE SHOCKERS BUT
IT'S GOOD TO GET FEEDBACK FROM
THE COMMUNITY IN WHAT PEOPLE ARE
LOOKING FOR AS THEY USE THE
TECHNOLOGIES ON THE FRONT LINES.
WE'RE TAKING THE INFORMATION
WE'RE GATHERING FROM THE SURVEYS
AND REFLECTING THEM BACK TO THE
DEVELOPER COMMUNITY AS WE PUT
OUT OUR CALLS FOR PROPOSALS AND
SAY WE WANT YOU IN YOUR
APPLICATION TO TALK ABOUT HOW
EASY YOUR TECHNOLOGY USES AND
DOESN'T RESULT THE CURRENT WORK
FLOW.
THAT'S OTHER
AS WE DEVELOP THE SURVEYS AND
LIKE WE HEARD THIS MORNING,
DEVELOPING TECHNOLOGYIES THAT
PEOPLE WANT BACK AND FORTH TO
MAKE SURE WE'RE DEVELOPING
THINGS THAT HAVE THE MOST VALUE.
>> THANK YOU.
>> IT'S NOT JUST GOOD AT THE
PATIENT HEALTH LEVEL BUT LOWER
HEALTH CARE COSTS.
THAT HASN'T HAPPENED IN MY
HEALTH CARE SYSTEM YET.
IN FACT ONE OF THE PAIN POINTS
IDENTIFIED BY CLINICIANS IN THE
NEGATIVE WAS CONCERN OVER
DISRUPTION OF THEIR WORK FLOW,
ADDED WORK AND ADDED IN-BASKET
MESSAGE, LACK OF DATA THEY COULD
USE TO MAKE A TREATMENT
DECISION.
COULD YOU HIGHLIGHT SOME OF THE
CONCERNS DR. LILLY, AND IN A
MOMENT WE'LL ASK DR. MANABE TO
TALK ABOUT THE INFECTIOUS
DISEASE CHALLENGES.
>> I WAS HONORED TO WORK WITH
NATE AND WE SELECTED A VERY
DIVERSE GROUP OF FOCUS GROUPS TO
MAKE SURE THE INSTRUMENT WE'RE
USING TO GATHER THE INFORMATION
WAS DOING SO ACCURATELY AND
ACCESSIBLE REGARDLESS OF
EDUCATIONAL LEVEL AND OTHER
BARRIERS.
SO EVERY YEAR HAVE DEPLOYED THE
SURVEYS.
WE HAVE LONGITUDINAL DATA AND
WHAT'S REALLY IMPORTANT AND
CONSISTENT ACROSS THE YEARS.
WHERE WE STARTED WAS WITH KEY
TECHNICAL ASPECTS WHICH ARE
ACCURACY.
THE GENERAL PUBLIC WANTS
ACCURATE TESTS BECAUSE THEY WANT
TO USE THEM FOR SELF-CARE.
ACCURACY MATTERS THAT BRUCE WAS
TALKING ABOUT EARLIER.
WE STARTED TO SEE PATIENTS WERE
TALKING ABOUT WANTING ACCESS TO
THE TEST AND WHO PAID FOR THEM
WAS INCREASINGLY IMPORTANT WE
WENT FROM MODEST LEVELS TO
PENETRATION AND WITH THAT IT
BECAME INCREASINGLY IMPORTANT
FOR PEOPLE TO BE ABLE TO AFFORD
THE TESTING.
THE OTHER THING WE FOUND IN THE
SURVEY WAS EASE OF USE.
IT'S IMPORTANT.
AND TALKING EARLIER ABOUT NEW
CHEMISTRY SETS AND WHATNOT.
THE TESTS HAVE TO BE EASY TO DO
AND IMPORTANTLY AND THIS IS
DIFFERENT THAN THE CLINICIAN
INFORMATION SIMPLE THINGS THAT
MAKING SURE WHEN YOU PRESENT THE
TEST RESULTS YOU DO IT IN MORE
THAN ONE LANGUAGE WAS IMPORTANT
TO THE PUBLIC.
SO I WANTED TO CLOSE WITH OUR
NUMBER ONE THING WHICH I THINK
IS SOMETHING I HOLD CLOSE TO MY
HEART.
WHEN WE SENT OUT THE FIRST
SURVEY I WASN'T SURE THE PUBLIC
WON'T LIKE POINT OF CARE TESTING
OR THOUGHT ABOUT WHAT WE WERE
DOING WAS A WASTE OF TIME.
THE 92% THE HIGHEST LEVEL OF
AGREEMENT OR EACH OF THESE ITEMS
YOU CAN AGREE OR DISAGREE AND
THERE'S A SCALE AND 92% FELT THE
INNOVATIVE PROGRAMS AT NIH
IMPROVED THEIR HEALTH.
>> WILL GIVEN YOUR EXPERTISE AS
AN INFECTIOUS DISEASE SPECIALIST
AND RESEARCHERS, WHAT DO YOU SEE
IN TERMS OF THE I.D. SPACE.
IN ADDITION TO SOME OF THE
CHALLENGES IN HEART AND
VASCULAR, THERE'S A STIGMA
ASSOCIATED IN SOME CASES AND
SOCIAL ELEMENTS WITH INFECTIOUS
DISEASES THAT ADDS A FURTHER
WRINKLE TO A PATIENT DOESN'T
WANT TO KNOW AND MAY NOT BE
COMFORTABLE SHARING THAT WITH
CLINICIAN.
WHERE DO YOU SEE OPPORTUNITY AND
CHALLENGES FOR POINT OF CARE OF
THE CLINICAL PERSPECTIVE OF I.D.
>> THANK YOU.
IT'S NICE TO BE A MEMBER OF THE
U-MASS CREW AND LOVELY TO WORK
WITH SO MANY IN THE AUDIENCE.
IT'S A GREAT MEETING.
IT'S A YIN AND YANG AND YOU NEED
HIGH SPECIFICITY TEST TO NOT
LOSE THE PUBLIC'S TRUST AND A
TEST NOT DONE HAS ZERO PERCENT
SENSITIVITY AND WE'VE COME UP
WITH THAT IN HIV, HEALTH OR
INFECTIOUS DISEASES WHERE
THERE'S GREAT STIGMA ASSOCIATED
PARTICULARLY IF THERE IS NO
CURATIVE THERAPY.
IT'S IMPORTANT TO THINK ABOUT
THAT.
THE OTHER AREA WHERE THERE'S A
YIN AND YANG IS IMPACT.
A DIAGNOSTIC TEST IS ONLY AS
GOOD AS USED.
IF YOU DO THE TEST AND LINK TO
CARE, YOU MAY NOT HAVE ANY
IMPACT OF HAVING DONE THE TEST
AT ALL.
ON THE OTHER HAND, IF YOU DON'T
AT LEAST KNOW YOUR STATUS IT'S
THE FIRST STEP IN THE CASCADE.
WOULDN'T YOU RATHER HAVE
SOMEBODY DO THE TEST AND MAYBE
YOU DO THAT IN THE FUTURE BUT AT
LEAST THEY HAVE AN OPPORTUNITY
TO KNOW WHERE THEY STAND WITH
MANY INFECTIOUS DISEASES AND
TRUE FOR HEPATITIS C AND HIV
WHERE THERE'S NO CURE AND FOR
CURATIVE ONE LIKE HEPATITIS C
AND STIs LIKE GONORRHEA AND
CHLAMYDIA AND AS A PHYSICIAN IF
YOU ASKED ME DO YOU WANT MORE
INFORMATION, ALL PHYSICIANS WILL
SAY YES.
THEY'RE NEVER GOING TO SAY, YOU
CAN KEEP THAT HIDDEN.
I'M NOT INTERESTED.
EVERYBODY WANTS MORE
INFORMATION.
IT'S VERY INTERESTING TO ME.
BUT PATIENTS DON'T ALWAYS WANT
TO KNOW SO WE TRY TESTING FOR
SYPHILIS AND HIV AT THE BALLS IN
BALTIMORE WHERE MANY MEN WHO
HAVE SEX WITH MEN WOULD GET
TOGETHER AND HAVE RAGING PART
YEAR AND WE THOUGHT WE'LL IS
HAVE A TABLE AND ON SYPHILIS BUT
NO ONE WANTED TO KNOW BEFORE
THEY GO PARTY AND WE COULD KNOW
AND NOT OVER USE ANTIBIOTICS AND
THOSE BALANCES ARE WHAT WE HAVE
IN MIND PARTICULARLY IN THE AREA
OF INFECTIOUS DISEASE AND FOR
THOSE OF US WHO CARE DEEPLY
ABOUT PUBLIC HEALTH.
>> THANK YOU, DR. MANABE.
I'VE SEEN IN POCTRN THE
IMPORTANCE OF PRESENTATION OF
DATA TO HAVE IMPACT.
IT'S NOT ENOUGH TO DO A TEST.
IT'S LIKE A TREE FALLING IN THE
FOREST WITH THE RESULT.
IT'S THE PERSON BEING THERE TO
WITNESS IT.
IT'S GETTING THE INFORMATION
INTO A HOSPITAL SYSTEM OR
CLINICIAN.
AND TRANSMISSAL OF IMPACT AND I
DON'T SEE A LOT OF POINT-OF-CARE
TESTS HAVING THAT
INTEROPERABILITY TO MY
ELECTRONIC HEALTH RECORDS TO SEE
OR USE A RESULT.
WHAT DO YOU SEE IN TERMS OF
CHALLENGES IN ACTIONABILITY OF
FINDINGS FROM A CLINICAL AND
HEALTH SYSTEMS PERSPECTIVE.
>> THANK YOU, DAVID.
ONE OF THE FIRST COMMENTS I HAD
RECEIVED AS I GOT INTO THE SPACE
WAS MANY OF MY MENTORS WHICH IS
HISTORY IS LITTERED WITH UNUSED
PREDICTIVE MODELS AND
POINT-OF-CARE TESTS.
THAT HAS BEEN TOP OF MIND IN
INTEGRATE THE RESULTS AND
INSIGHTS INTO THE DAY TO DAY
PRACTICE OF CLINICAL MEDICINE
NOT JUST FOR PHYSICIANS AND
ANCILLARY PROVIDERS AND NURSES.
I WANT TO BE ABLE TO WORK AT THE
TOP OF YOUR LICENSE AND LICENSE
IS SOMETHING STATIC WITH
POINT-OF-CARE TECHNOLOGIES WE
CAN EXTEND THE CEILING OF THE
LICENSES AND A CRITICAL FACTOR
IN BEING ABLE TO DO THAT IS
HAVING THE RESULTS AVAILABLE OF
THE CLINICAL WORK FLOW AND THE
CYCLE OF DATA TO KNOWLEDGE AND
KNOWLEDGE TO PRACTICE AND THEN
PRACTICE BACK TO DATA BEING ABLE
TO USE AND FUNDAMENTAL TO THAT
IS BRINGING IN INTEROPERABILITY
OF RESULTS TO CLINICAL WORK
FLOW.
THE ONLY THING WORSE THAN
CLINICIANS IS HAVING ONE MORE
INVESTED MESSAGE IS TO LOG INTO
A DIFFERENT PORTAL TO LOOK AT
THE RESULTS AND THEN BACK TO THE
AMR TO TAKE ACTION ON IT.
>> I WOULD CHALLENGE US ALL TO
THINK MORE DEEPLY ABOUT THIS.
OUR HOSPITAL SYSTEM IS TOO
ATYPICAL AND WHEN WE TRY TO
HANDLE HOW MANY IMAGES OF
POINT-OF-CARE TEST RESULTS AS
PART OF OUR DIGITAL HEALTH TRIAL
OUR WHOLE HEALTH SYSTEM WE
DIDN'T HAVE THE WAY TO SAVE THE
INFORMATION AND WHERE'S IT GO?
WHO STORES IT AND WHAT ARE THE
CHALLENGES TO PULL INSIGHT AT A
PARTICULAR TIME BE IT A
PARAMEDIC IN THE HOME, A NURSE
DOING POINT-OF-CARE ULTRASOUND
AND FACILITATE IN INTERPRETATION
AND WHEREAS OUR CURRENT MODEL
BASED ON CLINICAL CARE DELIVERED
IN A SILO NOW THAT THAT DATA'S
BEING GENERATED OUTSIDE THE SILO
IT INTRODUCES CHALLENGES TO
ACTIONABILITY AND IT'S MORE OF A
STATEMENT BUT I'D LIKE A
REACTION TO THAT.
>> ABSOLUTELY.
ELECTRONIC HEALTH RECORD SHOULD
BE A FINAL DESTINATION NOT THE
FIRST DESTINATION OF A LOT OF
THIS DATA ESPECIALLY GIVEN THE
INFO GRAPHIC OF THE
COMPUTATIONAL AND MODELLING WORK
BEING UNDER PINNING OF THE
ADVANCEMENT IN INNOVATION
HAPPENING.
SOME HAPPENS NATIVELY IN THE
TECHNOLOGY BUT THERE'S STILL A
LOT OF LEARNING THAT THAT NEEDS
TO HAPPEN IN THE MODELS OF
MACHINE LEARNING ALGORITHMS AND
IF WE BRING THAT IN WITHOUT
PROPER CONTEXT OR ACTION
ASSOCIATED WITH THAT IT'S GOING
TO FURTHER DILUTE THE STAGING
AND HAVE A RICH ENVIRONMENT
WHERE ALL THE DATA CAN BE
AVAILABLE TO FOLLOW THE TENET OF
NO DATA LEFT BEHIND.
WE UNDERSTAND MORE FROM NOT JUST
THE GOLD STANDARD CLINICAL
METRICS WE'RE SO WELL VERSED IN
BUT ALSO WHAT ARE THE MORE
RAPIDLY MEASURED AND MORE
FREQUENTLY MEASURED METRICS FROM
PATIENT'S HOME.
SOMETHING WE HAVE AS CLINICIANS
BECAUSE A LOT OF THE DATA WE ACT
ON IS WHAT'S AVAILABLE IN THE
EMR AND BRING THAT INTO A
STAGING ENVIRONMENT, INTO A
COMPUTATIONAL ENVIRONMENT WHERE
WE CAN CONTINUE TO LEARN AND
BRING THE INSIGHTS TO MEDICAL
RECORDS SO ACTION CAN HAPPEN BUT
BE CAREFUL AND INTENTIONAL ABOUT
WHAT DATA AND INSIGHTS WE'RE
BRINGING IN AND PARTICIPATORY
METHODS ARE IMPORTANT IN
THINKING ABOUT CAREGIVERS AND
CARETAKERS.
>> DR. MANABE.
>> I HAVE A FRIEND WHO SAY
PEDIATRICIAN AND DURING THE
HEIGHT OF COVID DID 126 TESTS ON
PATIENTS DURING HER BUSIEST DAY
AND I SAID DON'T YOU WANT A TEST
TO DIFFERENTIATE FLU AND COLD
SEASON SHE SAID I DON'T WANT
THAT TEST BECAUSE I DON'T WANT
THEM IN MY OFFICE.
I WANT THEM TO STAY HOME AND
CALL IN A PRESCRIPTION FOR FLU.
HE WERE WERE TRYING TO DEVELOP
THE MULTIPLEX TEST WE THOUGHT
WOULD BE SO USEFUL AND IF IT
TURNS OUT IF IT LOOKS AND SMELLS
LIKE FLU THEY'LL TREAT IT LIKE
FLU SO WE HAVE TO BE CAREFUL IN
WHAT WE DEVELOP AND EXPECT IT TO
BE USED AND I SPENT TIME TALKING
ABOUT USE CASE BUT IT'S USE
CASE, USE CASE.
WHO WILL USE IT AND WHY AND WHAT
IS IT USED FOR AND WE HAVE A
COLLECTION CALLED I WANT KIT.
IT'S FREE IN THE STATE OF
MARYLAND AND OTHER STATES AS
WELL AND WHAT'S INTERESTING
ABOUT THIS SERVICE IS IF YOU GO
BACK AND FIND OUT HOW MANY
PEOPLE WHO HAD GONORRHEA GOT
TREATED, MOST EVERYBODY GETS
TREATED.
MOST PEOPLE DON'T WANT TO WALK
AROUND WITH GONORRGONORRHEA.
THE 8% ARE THOSE WE CAN'T
CONTACT BUT TURNS OUT IF IT'S A
CURABLE ILLNESS WILL GET TREATED
AND THE OBSESSION OF KNOWING THE
RESULT AT A CENTRAL PLACE TO
PERSON WILL LINK TO CARE IS
PATERNALISTIC.
I THINK IF IT'S A CURABLE
ILLNESS PEOPLE WILL GET TREATED.
WITH DISEASES NOT CURABLE IT'S
HARDER BECAUSE OF THE STIGMA
LIKE RECURRENT HERPES OR HIV.
I THINK WE NEED TO DIFFERENTIATE
WHO WILL USE IT AND WHY AND WHEN
AND WE NEED IT TO BE CLEARER
ABOUT THE USE CASE AS WE'RE
DEVELOPING.
>> I THINK I'M HEARING DON'T
GENERATE DATA AND THROW IT AT ME
AT 5:00 ON FRIDAY WHERE I DON'T
KNOW WHAT MEANS AND DON'T HAVE
RESULTS AND HAVE TO DEAL WITH
IT.
YOU GOT THE DATA CHALLENGE
GENERATING GREAT STUFF BUT WHEN
THE ONUS THINK ABOUT
INTEROPERABILITY AND INTEGRATION
OF THE WORK FLOW AND IF YOU
REQUIRE THEM TO GO TO THE
WEBSITE AND THE DATA IS CLUNKY
TO INTEGRATE IN THE ELECTRONIC
HEALTH RECORD, LOWER ADOPTION
LIKELY WILL HAPPEN AND GIVE
THOUGHT TO THE WORK FLOW
ELEMENTS OF GENERATING DATA AT
THE RIGHT TIME AND GENERATING AN
INSIGHT WHEN IT WOULD LEAD TO
IMPACT.
I WANT TO GO INTO A SLIGHTLY
DIFFERENT PLACE WHICH IS A
POSITIVE PLACE BECAUSE AGAIN YOU
WERE EXPECTING CRUSTY CLINICIAN
BUT WE'RE PART OF THE FAMILY.
WE WANT TO GO INTO POTENTIAL
CLINICAL APPLICATIONS OUTSIDE
THE TELEMEDICINE CONSTRUCT WHICH
IS WHERE THE CENTER OF WHERE
PEOPLE START.
CLICK ON MY AMAZON BUTTON AND I
CAN GET A NURSE PRACTITIONER TO
SEE ME TO GET MY RESPIRATORY
TREATMENT OFTEN AUGMENTED WITH A
TEST E-MAILED TO MY CLUBHOHOUSE.
IT MAY ALSO REPLACE ALL HEALTH
CARE WITH AMAZON BUT THAT'S A
CONVERSATION FOR ANOTHER DAY.
THE OTHER USE CASES ONE IS THE
CONCEPT OF HOSPITAL AT HOME,
SKILLED NURSING AT HOME.
WE'RE SEEING MOVEMENT TO TAKE
CERTAIN CARE OUTSIDE THE BRICK
AND MORTAR HOSPITAL AND WITH
LICK ELECTRONIC ICUs TO ALLOW
FOR ICU MONITORING IN RURAL
SETTINGS AND OTHER SETTINGS
WHERE THERE'S NOT INTENSIVISM
AND THOSE ARE POINT-OF-CARE
TECHNOLOGIES IMPACTFUL.
PERHAPS YOU CAN TALK ABOUT THE
MOVEMENT IN THE HOSPITAL AT HOME
SPACE AND SOME INNOVATIVE WORK
WITH GETTING THERAPISTS TO USE
POINT-OF-CARE TECHNOLOGIES TO DO
SKILLED NURSING AT HOME.
>> PART OF THE RAPID
ACCELERATION OF CLINICIANS AND
ACCEPTANCE OF HEALTH
TECHNOLOGIES EXPANDED OUR
ABILITY TO PROVIDE CARE WHERE
AND WHEN.
A LOT OF IT WAS OUT OF NECESSITY
WITH HOSPITALS THAT NEEDED TO BE
STOOD UP BUT THE HOSPITAL BED
SHORTAGE CRISIS IS HERE TO STAY.
ANY GIVEN DAY IN WORCESTER,
MASSACHUSETTS WE'RE 80 TO 90
HOSPITAL BEDS SHORT AND WE
STARTED ONE OF THE LARGERER
HOSPITAL AT HOME PROGRAMS WHERE
ACUTE CARE IS IS PROVIDED
INPATIENT CARE IN A HOSPITAL BED
WHICH HAPPENS TO BE IN THE
BEDROOM.
THE ABILITY TO PROVIDE THE CARE
WITH CONFIDENCE WE'RE NOT GOING
TO LET SOMETHING ADVERSE HAPPEN
IS POSSIBLE BECAUSE OF THE
WEARABLE AND HOME-BASED
TECHNOLOGIES THAT ALLOW US TO DO
MORE MONITORING THEN WHEN
ADMITTED TO A HOSPITAL FLOOR AND
BY PROVIDING TO PATIENTS WE CAN
DECREASE RE-ADMISSION BY 50%
THROUGH REHAB AS OPPOSED TO A
SERVICE THAT UNFORTUNATELY AT
OUR MEDICAL CENTER WE CURRENTLY
HAVE.
WE NEED MULTIPLE PARTICIPANTS
TO INVOLVE CONTROLLERS LOOKING
AT THE DATA COMING IN AND
TRIGGERING AN ACTION AND WE HAVE
A PROGRAM CALLED MOBILE
INTEGRATED HEALTH AND WE CAN
EXTEND THE OPTIONS OF THE
TRADITIONAL EMERGENCY MEDICAL
SERVICES WHEN THEY GO TO A
PATIENTS HOLE.
IT'S EITHER DO YOU BRING THE
PATIENT IN TO EMERGENCY ROOM IF
THE PATIENT IS FEELING SICK AND
WANT TO COME IN OR YOU DO NOT DO
ANYTHING ELSE.
BUT WITH PARAMEDIC AT HOME
PROGRAM WE'RE ALSO EXTENDING
THAT TO INCREASE THE OPTION OF
ALLOWING THE OPTION OF
MAINTAINING THE PATIENT'S HEALTH
AT HOME WITH CLINICAL
SUPERVISION.
THE ACTION ARM OF BOTH WORKFORCE
LOOKING AT ALL THE SIGNALS
COMING IN FROM HOME-BASED
MONITORING AND ALSO HAVING THE
RESPONSE OF PARAMEDIC GOING TO
PATIENTS HOME TO STABILIZE AND
RESPOND TO ANY PROGRESSION OF
THE DISEASE.
>> COMMENT ON THE CONSTRUCT AND
HOW THAT WORKS WITH TYPES OF
SEN
SENSORS AND I DON'T THINK OF
POINT-OF-CARE IN THE ICU CARE
BUT THAT'S WRONG TO TELL US
ABOUT THAT.
>> STARTING WITH WHERE BRUCE WAS
WITH HOW IMPORTANT THE DATA IS
BECAUSE THERE'S A HUGE AMOUNT OF
DATA OUT THERE BUT THERE'S ALSO
AN IMPORTANT PROBLEM.
IF YOU'VE EVER BEEN IN AN ICU
YOU NOTICE IT'S NOISY IN HERE.
THERE'S B
THERE'S BEEPS.
THE BEEPS ARE PROBLEMATIC
BECAUSE THE PEOPLE GET
DESENSITIZED AND DON'T RESPOND.
WE REALIZED PEOPLE WERE GETTING
INTO TROUBLE BECAUSE THEY HAVE A
HIGH FALSE POSITIVE RATE SO WHAT
YOU DO WITH THE DATA MATTERS AND
PEOPLE WEREN'T RESPONDING.
WE HAD AN OFF-SITE TEAM THAT
USED ANALYTIC CHANGES OVER TIME
IF THE HEART RATE WENT UP AND
THE OXYGEN SATURATION WAS GOING
ON DIRECTED THE CARE.
THEY LOOKED AT THE SITUATION AND
SAID, OKAY, IS THERE A PROBLEM
HERE OR NOT AND IF THERE'S A
PROBLEM THE SECOND QUESTION THEY
ASKED IS WHERE THE NURSES ON TOP
OF IT?
YOU TURN ON THE CAMERAS AND
THERE'S NURSES IN THE ROOM
DEALING WITH IT AND A LOT OF
TIMES THERE AREN'T WHEN THAT'S
THE CASE AND YOU KNOW IT'S THE
REAL DEAL YOU REACH OUT AND SAY
IT'S NOT A FALSE POSITIVE.
WE NEED TO DEAL WITH THIS.
WHEN WE DID THAT, OUR MORTALITY
RATE WENT DOWN BY 30%.
OUR LENGTH OF STAY WENT DOWN AND
THE PROFIT OR MARGIN WENT WAY
UP.
WE PUBLISHED THAT IN THE
TELEMEDICINE SPACE.
ONE OF THE THINGS THAT ENABLED
THAT WAS THE BETTER THE DATA THE
BETTER WE WERE ABLE TO PREDICT.
WHEN WE WERE IN A WORLD OF HURT
BECAUSE WE STARTED OUT WITH A
BUNCH OF COVID PATIENTS COMING
IN AND SOME PATIENTS GET SICK
WITH THAT AND WE DON'T WANT TO
SEND ANYBODY HOME BECAUSE WE
THINK IT'S TOO DANGEROUS AN
DON'T HAVE THE SENSORS WE SHOULD
HAVE AND SENT IT OVER AND IT WAS
NOT THE MOST COMFORTABLE PLACE
TO STAY WITH BUT CAMERAS,
MICROPHONES AND WITH REGARDING
THE VITAL SIGNS AND BRINGING
THEM IN WE'RE ABLE TO KEEP TRACK
OF THOSE FOLKS.
DAVE AND PURVE SAID YOU CAN'T GO
OVER THERE BECAUSE YOU ARE
LIKELY TO GET SICK BUT IT WASN'T
PERFECT.
WHAT IS AMAZING IS THEY WENT
THROUGH AND SAID THAT GUY WILL
GET SICK.
AND WHEN WE CALLED AT THE DCU
AND SAID YOU HAVE TO CHECK OUT
THE GUY IN BED 23 IS GOING TO
GET SICK AND THE CONDITIONS ARE
INTERESTING.
THEY SAID WE'VE SEEN BED 23,
HE'S FINE AND TWO HOURS LATER
THEY'RE BACK ON THE PHONE SAYING
YOU SHOULD MOVE THEM BACK TO THE
MEDICAL CENTER.
WHEN APURV TALK ABOUT THE DATA
IN THE SPACE IT'S ANALYZING IT
AND FLIPPING THE PARADIGM,
SOMETHING'S WRONG WITH MY SEFT
I'M GOING TO CALL MY DOCTOR
PARADIGM ISN'T IT GOOD THE
DOCTOR REACHES OUT TO YOU AND
SAYING I'M CONCERNED.
>> GREAT, I'M CONSCIOUS OF
WRAPPING UP BY 10:15 AND PERHAPS
GET PANEL AND AUDIENCE REACTION.
WE SAW A REMARKABLE CHANGE IT'S
NOT JUST PATIENT'S WILLINGNESS
TO ACCEPT RESULTS AND THERE'S
LUNG ORE YENTDED RESULTS AND
THAT'S A TRANSFORMATIVE FACTOR.
NEVER LET A GOOD CRISIS PASS YOU
BY.
THE OTHER IS RESIGNATIONS.
WE'VE SEEN HALF OUR NURSES LEAVE
HEALTH CARE AND MANY PHYSICIANS
AS WELL.
IN FACT I BELIEVE ONE OF EVERY
THREE OR FOUR PRIMARY CARE
PHYSICIANS IS PLANNING TO RETIRE
OR LEAVE MEDICINE WITHIN THE
NEXT TWO YEARS AND WE DON'T HAVE
A PIPELINE TO REPLACE THEM.
POINT-OF-CARE TECHNOLOGIES WILL
PLAY A CRUCIAL ROLE AND WE'RE
RETHINKING THE ROLES OF HEALTH
CARE PROVIDERS WITH MUCH LESS OR
SHORTER TRAINING PERIODS
AUGMENTED BY PERHAPS A.I.
RUNNING ON A POINT-OF-CARE
DIAGNOSTIC INSTEAD OF RELYING ON
A PHYSICIAN'S DIAGNOSTIC
CAPABILITY AND THAT'S IN A NEW
HOSPITAL.
IN A NEW TOWER WE HAVE A
PARAMEDIC RUNNING ON AN A.I.
FACILITATED TELEMEDICINE
PLATFORM IN PATIENT.
AND THERE ARE NOW TEAMS BE
CONSTRUCTED WITHIN HEALTH CARE
THE DIGITAL HEALTH HUBS
MONITORING, REACTING AND ARE
MANAGING THE DATA GENERATED BY
POINT-OF-CARE OF SENSOR
TECHNOLOGY ONE IN THE ICU HOME
AND CREATING A VIRTUAL
HOSPITALIST?
I DIDN'T KNOW ABOUT THAT AND NOW
THEY EXIST.
SIMILARLY WITH THE CONTEXT OF
TELEMEDICINE AND IT TAKES A
SKILL SET TO PICK UP ON CUES AND
IT CHANGES THE LOCUST OF CONTROL
IN HOME-BASED CARE TO THE NURSE.
THE NURSE PLAYS A MORE CENTRAL
DIAGNOSTIC ROLE AND WE'RE SEEING
NEW TRAINING PROGRAMS EMERGE FOR
NURSES AND PHYSICIANS AND
THERE'S PHYSICIAN ENGINEERS AND
WE'RE SEEING AN EMERGENCE OF
TRAINING HEALTH PROGRAMS TO BE
MORE EXPERT USES OF
POINT-OF-CARE TECHNOLOGIES AND
BECOMING FAMILIAR WITH THE
NUANCED RESULTS THAT COME FROM
THEM AND DATA SCIENTISTS.
THAT'S A COHORT OF PEOPLE THAT
ARE REALLY ESSENTIAL FOR
POINT-OF-CARE INTEGRATION I HOPE
APURV'S COMMENTS HELPED.
WE WANTED TO LEAVE YOU WITH
POSITIVE CLINICAL SCENARIOS AND
PERSPECTIVES YOU MAY NOT HAVE
HEARD AND SOME CHALLENGES AROUND
WORK FLOW INTEGRATION AND LEAVE
YOU WITH FACTS THAT SHOW HOW
CLINICIANS ARE MORE OPEN TO
POINT-OF-CARE TECHNOLOGIES THEN
WHEN WE MET LAST IN PERSON AT
NIH.
A LOT OF CHANGE IN THE AREA.
WE'RE ALL GRATEFUL TO BE PART OF
THE FAMILY.
WE'RE PART OF THE POCTRN FAMILY
AND THANK YOU TO THE PANELISTS.
I APPRECIATED YOUR INSIGHTS AND
I'M SURE THE AUDIENCE DID TOO.
THANK YOU.
TIFFANI, I'LL LEAVE IT TO YOU IF
YOU THINK WE SHOULD TAKE A
QUESTION OR WRAP UP.
WE'LL BE HAPPY TO TALK WITH
FOLKS DURING THE MINGLING
PERIOD.
>> SOUNDS GREAT.
SO OUR PANELISTS WILL BE AROUND.
WE'RE GOING TO TAKE A QUICK
BREAK RIGHT NOW AND RECONVENE AT
10:30.
WE ALSO HAVE SNACKS AND SOME
CAFFEINE IN THE BACK.
ENJOY YOURSELVES.
LET'S GO AHEAD AND GET
STARTED HERE WITH OUR
DISTINGUISHED PANEL NUMBER TWO.
SO WE'RE WELCOMING THE INDUSTRY
PERSPECTIVES AND CHALLENGES
WHICH WILL BE CHAIRED BY WILBUR
LAM FROM EMORY UNIVERSITY AND
HIS PANEL.
>> THANK YOU EVERYONE FOR HAVING
ME HERE.
WE ARE MISSING ONE PANEL MEMBER
IF ANY OF YOU SEE DR. FERGUSON,
HE LOOKS LIKE THAT.
SEND HIM UP.
SO I'M SUPER EXCITED TO HEAD
THIS PANEL AND I REALLY WANT TO
MAKE THIS MORE OF A DISCUSSION.
WE HAVE THREE EXPERTS FROM
INDUSTRY AND I THINK THIS IS A
REALLY INTERESTING TOPIC BECAUSE
WE GET EXCITED ABOUT
POINT-OF-CARE TECHNOLOGIES AND
TALK ABOUT THE GREAT THINGS
COMING.
DR. TROMBERG TALKED ABOUT THE
VISION OF THE FUTURE AND
DR. McMANUS AND HIS GROUP
POINTED OUT EXCELLENT POINTS
ABOUT CLINICAL USE CASES.
WHAT ARE -- HOW WILL WE USE THIS
TECHNOLOGY, WHO WILL USE IT,
WHAT WILL THEY USE THE
INFORMATION AND HOW WILL THAT
CHANGE KLIN CAL MANAGEMENT AND
THERE'S ANOTHER BIG QUESTION
HERE.
WHO WILL BUY IT?
THAT IS A NECESSARY QUESTION IN
THE ENTIRE ECO SYSTEM.
IN THE ENTIRE PROCESS.
THESE GUYS THINK ABOUT THIS ALL
THE TIME AND WHAT WE DON'T OFTEN
TALK ABOUT ARE CHALLENGES FROM
THE INDUSTRY PERSPECTIVE.
I'M HONORED THE THREE OF OUR
EXPERTS ARE HERE.
IN FACT WHAT I'M GOING TO DO AND
I'LL HAVE EACH INTRODUCE
THEMSELVES AND SPEND A COUPLE
MINUTES TALKING ABOUT THEIR
COMPANY'S ORIGIN STORY AND WHAT
THEY'RE ABOUT AND GO ONE BY ONE
AND THEN WE'LL START DIVING INTO
QUESTIONS THAT EVERY SINGLE
INDUSTRY PARTNER THAT WE HAVE IN
OUR POINT-OF-CARE ECO SYSTEM HAS
TO DEAL WITH.
SEVERAL QUESTIONS.
SO FIRST IS DR. FERGUSON WITH
APT TUTE YOU CAN ADVANCE THE
SLIDE.
I'M SCOTT FERGUSON, FOUNDER AND
CEO OF APTITUDE.
WHAT I PUT ON THE SLIDE IS
APTITUDE'S CORE GOAL TO
DEMOCRA
DEMOCRATIZE DIAGNOSTICS.
ONE CRITICAL ELEMENT IS IMPROVE
ACCESSIBILITY.
SO ALLOW INDIVIDUALS TO BE ABLE
TO ACCESS DIAGNOSTIC INFORMATION
AND WHAT IF WE CAN EMPOWER
PATIENTS AS PARTICIPANTS IN
HEALTH CARE AND NOT JUST BE
PATIENTS.
THAN ONE CORE ELEMENT.
SECOND, LAB QUALITY IN A FORM
ANYONE CAN EXECUTE ANYWHERE AND
THE THIRD ELEMENT IS COST.
ALL YOU TYPICALLY PAY IS A
CO-PAY IF WE'RE GOING TO ENABLE
BROADER USE OF DIAGNOSTICS
OUTSIDE THE TRADITIONAL CARE
PARADIGM AND APT TUESDAY'
PURSUING A NUMBER OF PRODUCTS
BUT WE HAVE ONE THROUGH UA.
IT WAS CALLED THE METRICS
COVID-19 TEST.
IT WAS THE FIRST OVER THE
COUNTER TEST WITH SALIVA AND
SWAB SAMPLES.
AND THESE ARE AUTHORIZED FOR USE
IN THE HOME SETTING BY LAY
USERS.
ALSO CAN BE USED IN PROFESSIONAL
SETTINGS AND I'LL TALK MORE
ABOUT THAT LATER.
THAT'S THE KEY THING.
IT CAN BE USED BY LAY USERS FOR
ASYMPTOMATIC USE WITH GREAT
PERFORMANCE.
WE WERE ABLE TO GET ACROSS THE
USER GROUPS A 97% PPA AND MPA
COMPARED TO A HIGH PERFORMANCE
LAB-BASED RPTCR.
WE'RE DELIVERING ON THAT PROMISE
AND WE'VE GOT A NUMBER OF OTHER
PRODUCTS IN THE PIPELINE WE'LL
CONTINUE WITH THIS THEME.
THAT'S A BIT ABOUT APTITUDE.
>> GREAT.
NEXT IS ERIKA TYBURSKI AND I'M A
CO-FOUNDER AND ERIKA'S CHIEF
MEDICAL OFFICER AND SHE'S CEO
THEREFORE SHE'S MY BOSS SO GO
AHEAD AND TALK TO SANGUINEA.
>> I STARTED IN THE MEDICAL TECH
PROJECT AND MYSELF I DEALT WITH
NUTRITIONAL DEFICIENCY ANEMIA MY
WHOLE LIFE AND WILBUR BEING A
HEMATOLOGIST SEEING PATIENTS ALL
THE TIME WE HAD A PROFOUND
EXPERIENCE WITH IT AND REALIZED
BETTER ACCESS TO UNDERSTANDING
WHERE YOUR BODY IS AT A CERTAIN
POINT IN TIME IS CRITICAL IN
SYSTEMS AND IN HOME.
WE SPUN OUT OF THE GEORGIA TECH
SYSTEMS AND GOT THROUGH SEED
FUNDING AND OUR FIRST PLATFORM
IS ON ANEMIA MANAGEMENT.
WE HAVE A SIMPLE POINT OF CARE
TEST AND SIMPLE BLOOD SAMPLE
TEST WHERE YOU MIX IT WITH OUR
VIAL AND IT WAS FDA CLEARED
SEPTEMBER 29th OF THIS YEAR.
AND WE HAVE AN ONLINE PART AND
HAPPY TO DIVE INTO ANY OF THAT.
WE ALSO HAVE A PIPELINE OF OTHER
BIOMARKERS WE'RE LOOKING AT THAT
FOR US UNIQUELY ARE NOT ONLY AT
THE POINT OF DISEASE BUT CAN
POTENTIALLY BE LOOKED AT EARLIER
AS VITAL SIGNS TO PREVENT ANY OF
THESE PROBLEMS.
THERE'S A BIG DICHOTOMY GOING ON
WHEN YOU ASK WHO CAN PAY FOR IT
AND WHO SHOULD PAY FOR IT AND
WHO IS WILLING TO AT THIS POINT
IN TIME BECAUSE I THINK THERE'S
A LOT OF PAYMENT OPTIONS ON WHEN
YOU ALREADY HAVE A DIAGNOSIS AND
IN THE TEST TO TREAT PHASE BUT
WE'RE LOOKING AT THE BIOMARKER
AND HOW IT EXISTS IN PEOPLE AND
PARTICIPATE IN THE PREVENTIVE
SIDE.
PASSIONATE ABOUT EVERYTHING
SCOTT WENT THROUGH AND HAPPY TO
BE HERE.
>> GREAT, THANKS ERIKA SHE'S
ALSO A REGULATORY EXPERT AND
MANY WORK WITH HER UNDER THAT
PURVIEW.
OUR LAST PANELIST, ERIK
ENGELSON, PLEASE TALK ABOUT YOUR
ADVENTURES WITH LUCERA.
>> THANK YOU, I'M A
MICROBIOLOGIST AND BIO ENGINEER
AND STUDIED BUSINESS AND
CURRENTLY STUDYING A.I.
IT'S GREAT HAVING STANFORD AT
THE BACK DOOR.
I'M BASED IN SILICON VALLEY.
HAVE BEEN FOR MY ENTIRE CAREER
AND THERE'S A BIG MEDICAL DEVICE
INDUSTRY IN SILICON VALLEY.
I SPENT ALMOST ALL MY CAREER
WITH THE EXCEPTION OF LUCERA IN
INTERVENTIONAL MEDICAL DEVICES
ON THE VENTURE SIDE AND RUNNING
COMPANIES.
IF ANYONE KNOWS WHOSE CEREBRAL
ANEURYSM WAS CURED BY COILS WE
CREATED THAT COMPANY AND WHILE
I'M PROUD OF THE ANEURYSM
DEVICES, ESPECIALLY OF THIS
GORGEOUS PRODUCT WHICH PFIZER
NOW OWNS AND MANY WENT TO PFIZER
AND EXCITED TO SEE THE PRODUCT
AVAILABLE ON AMAZON STILL.
THIS IS OUR FIRST PRODUCT AT
LUCIRA WAS A COVID-ONLY PRODUCT.
THIS IS A KIND PRODUCT WITH FLU,
A FLU B THAT GIVES THE
DIFFERENTIAL DIAGNOSIS BASED ON
ONE NASAL SWAB.
IF YOU'RE CONFUSED ABOUT YOUR
SYSTEMS AND GET THE ANSWER ON
THE SPOT AS WAS MENTIONED UP
HERE EARLIER YOU CAN TAKE AN
ANTIVIRAL AND BE ON YOUR WAY AND
MY FAMILY'S USED IT AND TAKEN
THE ANTIVIRALS AND WORKED AS
EXPECTED.
THE LIMIT OF DETECTION OF THE
COVID ASSAY IS TEN TO THE SECOND
YOU CAN FIND ASYMPTOMATIC
POSITIVES.
THAT'S CRITICAL OR HAS BEEN IN
OUR MINDS AND SO WE'RE VERY
PROUD OF THIS PRODUCT.
>> LOOKING FORWARD TO HEARING
MORE AND LET'S DIVE INTO IT.
WHEN I WAS INTERESTED IN
DIAGNOSTICS IN SILICON VALLEY
AND IN YEARS PAST THE ROI IN THE
DIAGNOSTIC INDUSTRY WAS LOW
COMPARED TO OTHER THINGS LIKE
THERAPEUTICS AND CERTAIN DRUGS
AND SO FORTH.
SO HOW DID YOU GUYS DEAL WITH
THAT AND HAS THAT CHANGED WITH
THE PANDEMIC OR EVEN NOW?
HAS IT GONE BACK?
I'D LOVE TO HEAR EACH OF YOUR
THOUGHTS.
MAYBE STARTING WITH SCOTT.
>> SO I THINK THE ROI EQUATION
DEFINITELY HAS BEEN VARIABLE
OVER THE PAST FEW YEARS.
SPECIFICALLY THAT'S IMPORTANT
FOR HOW A DIAGNOSTIC COMPANY
GOES FROM NOTHING TO HAVING A
PRODUCT.
YOU NEED MONEY TO BE ABLE TO DO
THAT.
YOU NEED TO BE ABLE TO
COMMUNICATE THE ROI STORY.
THERE'S DIFFERENT BUCKETS OF
FUNDING SOURCES THAT CAN
RESONATE.
SOME ARE INSTITUTIONAL
INVESTORS.
AND OTHERS ARE FOR EXAMPLE THE
NIH AND THE RADX PROGRAM AND
BARDA AND OTHER FUNDING SOURCES
AND GATES FOUNDATION THAT CAN
HELP TO NAVIGATE STAGES WHERE
THE ROI EQUATION DOESN'T LOOK
GOOD FOR AN INSTITUTIONAL
INVESTOR.
FOR DIAGNOSTIC COMPANIES THAT
COME INTO THE SPACE TYPICALLY
THIS IS BECAUSE OF SOME
BREAKTHROUGH USUALLY ON THE
TECHNOLOGY SIDE.
THAT'S GREAT BUT IT'S ONE PIECE
OF A LARGE PUFL THAT NEEDS TO
COME TOGETHER IN ORDER FOR THAT
R TO BE REALIZED DOWN THE LINE.
THERE'S A NUMBER OF DERISKING
STEPS THAT HAVE TO HAPPEN ON
THAT JOURNEY.
THERE ARE CERTAIN DERISKING
STEPS THAT ARE REALLY GOOD FOR
VENTURE MONEY TO PARTICIPATE IN
AND CERTAIN DE RISKING STEPS
THAT ARE DIFFICULT FOR VENTURE
MONEY TO PARTICIPATE IN.
MY ADVICE FOR ANOTHER DIAGNOSTIC
COMPANY IS TO LOOK AT THE
DIFFERENT BUCKETS OF MONEY THAT
CAN BE OUT THERE AND USE THEM AS
A PORTFOLIO TO HELP GET THE JOB
DONE AND REALIZE THAT ULTIMATE
POWER.
>> THE PANDEMIC FOR OUR COMPANY
WAS A SILVER LINING.
THE MODEL WE WERE FACING WHEN WE
WOULD PITCH AND GET TO THE POINT
IS WELL, I'VE GOT THIS GIANT
MACHINE THAT LIVES IN A TERTIARY
HOSPITAL AND WE RUN BLOOD DRAWS
AND GET THIS PARAMETER AMONGST
OTHERS ON THE PANEL SO WHY WOULD
I BE INTERESTED IN USING THIS
AND REIMBURSEMENT IS ALREADY SET
LOW AND SOMETHING DIAGNOSTICS
FACE BUT DURING THE PANDEMIC THE
MODEL OF SENDING PEOPLE SICK AND
HEALTHY TO ONE PLACE WAS FLIPPED
ON ITS HEAD.
WE NOW HAD THE NEED FOR
POINT-OF-CARE AND HOME TEST
SITES CAN DO.
THE CVSs AND WALGREENs OF THE
WORLD ENDED UP BEING THE NORM
OPPOSED TO GOING INTO A CLINIC
WHERE YOU WERE TRYING TO SERVE
THE SICKEST OF THE SICK.
THAT MANTRA HELPED WITH OUR
INVESTORS.
WE CLOSED OUR FIRST SEED ROUND
IN JULY OF 2020 WHEN THIS WAS
ALREADY STARTING AND WERE ABLE
TO CLOSE A SMALL SERIES A IN
JUNE OF THIS YEAR.
WHEN WE THINK OF ROI IT'S NOW
BROADENED TO THE MODEL BREAKING
THE TECHNOLOGY AND A HUGE DATA
ELEMENT WE'LL LIKELY GET INTO
AND UNDERSTANDING ON THE
INDIVIDUAL LEVEL WHAT YOU CAN DO
WITH DATA AND THE POPULATION
LEVEL WE'VE SEEN EXAMPLES WITH
IN THE PANDEMIC.
>> WHILE I'VE BEEN INVOLVED IN
START-UPS AND IN ANY LAST FOUR
COMPANIES I'VE BEEN CEO I'M COME
IN LATER AFTER THE TECHNOLOGY
RISK HAS BEEN SHAKEN OUT ON $10,
$15 MILLION AND NOW IT'S TIME TO
SCALE AND GET THROUGH FDA AND
BUILD A COMMERCIAL TEAM AND
REALLY GO FROM WHERE EVERYTHING
ARE TO 60 MILES AN HOUR.
AT LUCIRA IT TOOK A LOT OF
CAPITAL AND TWO-THIRDS WAS FROM
THE PUBLIC MARKETS.
IT IS VERY EXPENSIVE.
AND THE THING THAT MAKES THIS
CHALLENGING NUMBER ONE THIS IS
AN OTC PRODUCT.
OUR DEVELOPMENT AIM WAS NOT TO
PUT IN PHYSICIAN OFFICES THOUGH
IT WILL HAVE A GREAT USE CASE
THERE AND WILL BE PURSUED BUT
NOT RECEIVING OTC FIRST BUT
GOING THROUGH POC LABEL FIRST
AND THEN OTC WAS NOT HELPFUL TO
US.
WE WERE GEARED TO SELL INTO OTC
FOR HOME USE.
SO IT TAKES A LOT OF MONEY FOR
THE SUPPLY CHAIN TO GET READY
FOR RERP -- RESPIRATORY SEASON
AND YOU HAVE TO BE ABLE TO CARRY
THE WORKFORCE IN OUR CASE, 13
PEOPLE THROUGH THE NEXT
RESPIRATORY SEASON.
THAT'S NOT TRIVIAL.
INVESTORS ARE WATCHING AND WILL
NOT INVEST IF THE PROCESS IS NOT
MORE PREDICTABLE.
THAL THAT'S ONE CHALLENGE AND
INTERVENTIONAL DEVICE WHERE I
SPENT MOST MY CAREER THE GROSS
MARGINS IS IN THE RANGE OF 75%
NORTH.
SO THAT GIVES YOU SOME
FLEXIBILITY.
IN DIAGNOSTICS THE GROSS MARGINS
ARE MAYBE 55% IF YOU'RE LUCKY.
THAT MEANS THINGS RUN TIGHT.
IN Q1 OF '22 WE HAD A $90
MILLION QUARTER AND THAT
PRODUCED NET INCOME.
NOT PROFITABILITY BUT NET
INCOME.
WE'RE ON THE RIGHT PATH AT THAT
POINT.
THAT'S VERY HARD TO GET TO AND
AGAIN IT WAS THE PANDEMIC THAT
GOT US THERE.
IT'S A CHALLENGING SPACE FOR
THOSE REASONS.
WHEN YOU HAVE INVESTORS WHAT DO
YOU DO TO GET THEM TO BUY IN?
ANYBODY.
>> I HAD THAT CONVERSATION THE
OTHER DAY FOR AN INVESTOR FOR
ANOTHER COMPANY AND DOING CHEST
THUMPING HOW LUCIRA TOLD $250
MILLION WORTH OF THE PRODUCT AND
HE SAID THAT WAS THE PANDEMIC.
SO THEY COMPLETELY DISCOUNT WHAT
WAS ACHIEVED IN THE PANDEMIC.
>> IT'S FRANKLY A BLOOD WATH OUT
THERE.
>> THERE'S A GLUT OF COMPANIES
RIGHT NOW.
THE PANDEMIC BROUGHT TOGETHER A
LOT OF APPROACH TO TRY TO SOLVE
SINGULAR PROBLEM AND THEN THAT
SINGULAR PROBLEM WHICH
PREVIOUSLY REQUIRED TESTING THAT
WENT AWAY.
THE GOVERNMENT'S ALSO PROVIDING
FREE TESTS WHICH MAKES IT A
DIFFICULT COMPETITOR OUT THERE.
AND SO FOR COVID ITSELF AS A
LEAD PRODUCT IS THE COVID TEST,
THAT'S A TOUGH MARKET AND
DIFFICULT FOR INVESTORS TO
COMPUTE A GOOD ROI ON.
I LIKE THE SLIDE THAT SHOWS HOW
BIG AT-HOME TESTING WILL BE IN
THE FUTURE AHEAD BUT AT THE SAME
TIME THERE'S SIGNIFICANT MARKET
DEVELOPMENT THAT HAS TO EXIST ON
THAT FRONT.
PREVIOUS TESTING WAS REQUIRED
AND WHEN YOU REMOVE THAT
REQUIREMENT YOU'RE RELYING ON
THE OTHER FACTORS AND IT'S NOT
SO SAY THEY'RE NOT THERE BUT AT
THE ORDER OF MAGNITUDE MORE
DIFFERENT SCALE.
>> THEY'RE REQUIRED TO TEST
VERSUS WANT IT AND NICE TO TEST
IS SOMETHING WE'RE SEEING.
I THINK I'M THE ONLY COMPANY
HERE WHERE THE LEAD PRODUCT IS
NOT WITH AN INFECTIOUS DISEASE.
WE DON'T HAVE A COVID-19 TEST.
FROM MY PERSPECTIVE I GET THAT
QUESTION AND WE'VE BEEN ABLE TO
WORK IN THE CHRONIC DISEASE
MANAGEMENT SPACE FIRST WHERE
THERE'S REQUIREMENTS TO TEST.
THERE'S CERTAIN LEVELS OF
HEMOGLOBIN WHERE CERTAIN DRUGS
CAN AND CAN'T BE ADMINISTERED
AND YOU CAN WORK IN THAT PATH.
THAT'S A FORTUNATE ANGLE FOR ME
BUT IF IT WERE TOTALLY
PREVENTIVE IT'S NEAR IMPOSSIBLE
TO GET AN INVESTOR TO ALIGN
BECAUSE IT'S NICE TO HAVE AND IT
RELIES ON EDUCATION ALMOST
ENTIRELY DIRECT TO CONSUMER
WHICH EVERYBODY KNOWS IS
EXPENSIVE.
IT CAN BE EXPENSIVE SO INVESTORS
WILL SEE I NEED HUNDREDS OF
MILLIONS TO DO THIS.
FOR ME THE PANDEMIC OPENED EYES.
THEY'RE MORE INTERESTED IN
ACCESSIBLE CARE AND WHAT NOT AND
FOR US WE'VE BEEN ABLE TO WORK
IN MANY SEGMENTS WHILE TRYING TO
WORK ON THE ENGAGEMENT AND
EDUCATION PIECE.
>> ONE TIDBIT IS FOCUS AND THERE
NEEDS TO BE A PIVOT.
>> WE'RE STILL A SMALL COMPANY
THERE'S ABOUT 50 AND A SPINOUT
FROM U.C. SANTA BARBARA AND
EXISTED ABOUT 10 YEARS OR SO.
WE'RE JUST NOW GETTING OUR FIRST
PRODUCT OUT THERE.
IT'S BEEN A LONG JOURNEY.
THE PRIOR TO COVID-19 WE'RE
STILL WORKING ON DIAGNOSTICS BUT
DIFFERENT DIAGNOSTIC PRODUCT
WITH THE SAME UNDERLYING GOAL OF
IMPROVING ACCESSIBILITY TO TEST
THAT HAVE IMPORTANT INFORMATION
THAT CAN INFLUENCE THE COARSE
-- COURSE OF PATIENT CARE AND
MANAGEMENT AND TREATMENT.
WELL, COVID WAS HAPPENING AND
THE THINGS THAT WERE HARD TO DO
GOT HARDER.
WE PERCEIVE THE POTENTIAL TO
EXPAND COVID AND CAPABILITIES
AND WE MADE THAT PIVOT AT THAT
TIME.
EVEN IN COVID HEYDAY WE HAD SOME
REASONABLE AMOUNT OF FUNDING
THROUGH A STRATEGIC INVESTMENT.
WE HAD A WE WERE PART OF THE
RADX REDIRECT GROUP AND RADX
ONE.
THEY WERE HELPFUL BUT WE NEEDED
MORE MONEY TO GET STUFF DONE.
WELL, WE WERE -- YOU MENTIONED
FOCUS.
WE WERE LASER FOCUSSED ON THIS
PRODUCT BUT WHAT WE ALSO
RECOGNIZED AT THE SAME TIME WAS
WE'RE LOCATED IN CENTRAL,
CALIFORNIA, THERE WAS A DEARTH
OF TESTING CAPABILITIES.
WE SET UP A LAB AND DEVELOPED AN
LDT TO DO HIGH THROUGHPUT
TESTING FOR CENTRAL CALIFORNIA
AND BECAME THE LEADING COVID
PROVIDER TEST AND RAN 400 TESTS
OR SO AND GENERATED REVENUE WE
WERE ABLE TO PUT INTO DEVELOPING
PRODUCT AND THAT WAS A GOOD
PIVOT BUT AT THE TIME YOU DON'T
KNOW IT'S GOING TO TURN OUT
OKAY.
THOSE PIVOTS CAN BE SCARY.
THAT'S THE NATURE OF A LOT OF
THE CHALLENGE FOR A START-UP.
YOU REQUIRE GOOD JUDGMENT.
I'M NOT TRYING TO SAY WE HAVE
REALLY GOOD JUDGMENT, WE GOT
LUCKY THERE BUT A LOT OF THE
DECISION HAVE TO GET MADE ARE
VERY HIGH STAKES DECISION AND
YOU HAVE TO PLACE BETS.
WE DID THAT.
SO PIVOTING COULD BE A NATURAL
THING TO DO BECAUSE OFTEN TIMES
YOU MADE A JUDGMENT CALL THAT
WAS KIND OF CRAPPY EARLIER AND
YOU HAVE TO PIVOT BASED ON NEW
LEARNINGS AND I CAN GO ON ABOUT
OTHER PIVOTS TOO BUT THOSE WERE
TWO SUCCESSFUL ONES.
>> TWO PIVOTS.
ONE IN THE ANEURYSM DAY AND ONE
STARTED WITH A NEED OF
MICROCATHETERS AND HELP WITH THE
LIVER.
IT TURNED OUT SERENDIPITOUSLY
THAT MICROCATHETER CAN ACCESS
FIRST-ORDER VESSELS OFF CIRCUITS
IN THE BRAIN AND THE FIRST TOOL
FOR THE RADIOLOGY WHICH WAS
EXCITING.
AT LUCIRA PRIOR TO MY ARRIVAL
STARTED DEVELOPING STI TESTS AND
MOVED TON FLU BECAUSE THEY
THOUGHT THAT WOULD BE MORE
READILY APPROVABLE AND COVID HIT
WHEN I WAS ALREADY AT THE
COMPANY AND SWITCHED TO COVID.
SCOTT'S RIGHT ON THESE ARE HUGE
BET THE COMPANY DECISIONS
ESPECIALLY WITH A SUPPLY CHAIN
AND DIAGNOSTICS.
>> FUR OUR FIRST BIOMARKER BEING
ANEMIA MY FIRST NAIVETY IS I'LL
FIND THE BIGGEST DISEASE STATE
WHERE ANEMIA EXISTS AND GO AFTER
PATIENTS WITHOUT CONSIDERING WHO
WILL USE IT, WHY AND ULTIMATELY
IT WAS A PIVOT AND MIND SET HOW
TO PITCH AND WHO IS GOING TO USE
THIS.
WE ACTUALLY HAD ENTITIES COMING
TO US AND FIND US DOING GOOGLE
SEARCH SAYING BIG PHARMA
COMPANIES SAYING IT'S NICE
YOU'RE DOING THIS BUT COULD YOU
HELP ME IN MY CLINICAL TRIAL
HERE BECAUSE I'D LIKE TO CAPTURE
THE DATA AND IT'S TAKING A BET
PUTTING SOME EFFORT THERE BUT AT
THE END OF THE DAY BECAME A PAID
CONTRACT AND ENDS UP BEING PART
OF YOUR MODEL AND STORY.
>> ONE THING WE TEND TO NOT TALK
TOO MUCH IS THE ISSUES RELATED
TO MANUFACTURING
>> IF YOU CAN OFFER TIDBITS IN
MANUFACTURING.
>> I THINK IT DEPENDS ON THE
NATURE OF THE COMPANY AND WHAT
IT'S TRYING TO DO AND MARGINS
AND DIAGNOSTICS IN GENERAL DON'T
GIVE YOU THAT MUCH ROOM TO PLAY.
WHEN YOU'RE TRYING TO DO WHAT
WE'RE TRYING TO DO WHICH IS ALSO
BRING DOWN COST A WHOLE LOT,
THAT MARGIN BECOMES EVEN MORE
APPRECIATION.
-- PRECIOUS.
THE ALLURE OF HOW DO YOU
MANUFACTURE STUFF?
GENERALLY, IF YOU'RE A LITTLE
COMPANY AND DIDN'T HAVE THAT
MUCH MONEY BEFORE YOU DON'T HAVE
A BUNCH OF EQUIPMENT AND PEOPLE
AND A MANUFACTURING OPERATION
AND WANT TO REPLY CONTRACTORS
FOR SPEED AND INITIAL
EFFICIENCIES AND SO ON.
THIS BECOMES A TRICKY THING TO
DO BECAUSE I REMEMBER WHEN I
WAS -- I'M STILL PRESENTEE DUMB,
BUT WHEN I WAS DUMBER, I THOUGHT
ONCE YOU GET TO MANUFACTURE ALL
THE PROBLEMS GO AWAY AND THEY
JUST AMPLIFY.
YOU HAVE TO SORT THEM OUT.
FOR US, OUR VALUE PROPOSITION IS
TIED NOT JUST TO THE PERFORMANCE
BUT ALSO THE COST.
SO THAT THING WE HAVE TO
UNDERSTAND THE PROCESSES MORE
THAN ANYBODY ELSE BECAUSE THAT'S
ALSO WHERE WE KNOW -- INNOVATE
AND DON'T HAVE THE RESOURCES TO
DO IT.
YOU NEED TO COME UP AGAIN WITH
CLEVER STRATEGIES FOR HOW TO NOT
JUST ESSENTIALLY HAND OVER LIKE
HEY, GUYS, PLEASE MAKE THIS
THING NOW.
THAT'S NOT GOING TO WORK OUT.
YOU'RE NOT GOING TO BE ABLE
TO -- FOR US IT'S NOT GOING TO
WORK OUT BECAUSE WE NEED THAT
INFORMATION AND NEED TO COMPLETE
THE INNOVATION CYCLES AND DRIVE
COSTS DOWN NOT JUST FOR THE
PROCESSES TO MAKE THE THING BUT
ALSO FOR THE DESIGN ITSELF IF
YOU START WITH A DESIGN THAT'S
GOING TO BE HARD TO MANUFACTURE
YOU'LL HAVE A BAD TIME.
SO THE EXTENT YOU CAN GET THIS
INFORMATION VERY EARLY ON IN THE
DEVELOPMENT PROCESS OF YOUR
PRODUCT, YOU WILL AVOID A LOT OF
FUTURE PAIN.
AND SO IT CAN BE DONE.
YOU CAN GET KNOWLEDGE ABOUT
MANUFACTURE AND DO SOME SMALL
SCALE PILOT MANUFACTURE STUFF
WITH METHODS THAT CAN TRANSLATE
WITH CONTRACT MANUFACTURERS.
MY SUGGESTION FOR ANYONE IN THIS
CONUNDRUM IS DON'T JUST THROW IT
OVER THE FENCE AND HOPE THESE
GUYS WILL SOLVE EVERYTHING FOR
YOU.
>> SCOTT'S GIVING AN IMPORTANT
WARNING SOMETIMES EARLY STAGE
FOLKS THINK THEY CAN JUST SIGN
UP A CONTRACT MANUFACTURER AND
IT WILL ALL BE FINE.
YOU NEED TO HAVE YOUR OWN AT
LEAST DEEPLY EXPERIENCED IN
MANUFACTURING AND SOMEONE IN
QUALITY, ETCETERA, EVEN IF YOU
HAVE CONTRACT MANUFACTURER BUT
KEEP IN MIND YOUR TRYING TO
SPLIT HAIRS TO GET MARGIN AND SO
ARE THEY AND NO ONE WILL CARE
MORE ABOUT YOUR PRODUCT THAN YOU
DO AND THEY HAVE A PORTFOLIO OF
CUSTOMERS, YOU HAVE JUST
YOURSELF.
IT'S ANOTHER CRITICAL DECISION.
>> I'D LOVE TO INVITE ANY
QUESTIONS FROM THE AUDIENCE.
FEEL FREE TO COME UP TO THE MIC.
THERE'S ALREADY A QUESTION.
CLEARLY WITH A BILLION TESTS
DISTRIBUTED THE CULTURE HAS
CHANGED AND THE MOST PRIOR TO
THAT HOME PREGNANCY TEST ON THE
ORDER TO $7 MILLION TO $8
MILLION A YEAR AND THE CULTURE
IS A POSITIVE FEATURE.
AS YOU POINT OUT, THERE'S A LOT
OF COMPLICATIONS AND
DIFFICULTIES WITH MARGINS,
RETURN ON INVESTMENT.
PARTIALLY BECAUSE OF THE
REGULATORY PATH AND IF I GO BACK
IN TIME WHEN WE FIRST STARTED
THE PERFORMANCE OF HOME TESTS
THE FDA HAD THE BAR REVERSED.
NOW THE HOME TEST PERFORMANCE IS
ACTUALLY LESS IN TERMS OF RIGOR
THAN THE POINT OF CARE.
IT WAS HARDER TO GET A HOME
AUTHORIZATION AT THE BEGINNING
OF THE PANDEMIC.
THE PERFORMANCE I THINK THE PPA
HAD TO BE BETTER THAN 90% OR I
DIDN'T REMEMBER -- THERE WAS
HOME BY CONSUMERS AND THE FDA
DIDN'T WANT CONSUMERS TO HAVE
ANY POSSIBILITY OF APE INCORRECT
ANSWER AND THERE WAS
PRESCRIPTION AND POINT OF CARE
AND THOSE WERE THE CATEGORIES.
THE PPA IS DIFFERENT FROM HOME.
I'M LOOKING AT WHAT IS THE ROLE
OF REGULATORY IN YOUR ABILITY TO
REACH THE MARKET.
WE'VE SEEN SO MANY CONSUMER
DEVICES AND ARE YOU GOING TO TRY
TO GO THE WAY OF DIRECT TO
CONSUMER WITHOUT STOPPING AT THE
FDA FIRST OR DO YOU THINK THERE
ARE OPPORTUNITIES LIKE WITH OVER
THE COUNTER HEARING AIDS TO
CREATE ENTIRE NEW REGULATORY
CATEGORIES PERHAPS WITH SOME
STANDARDIZATION LIKE HAS BEEN
DONE WITH HEARING AIDS?
HOW CAN YOU REALLY QUICKLY TAKE
ADVANTAGE OF THIS NEW MARKET
LIKE EVERYBODY'S AWAKE AND YOU
HAVE EVERYBODY'S ATTENTION BUT
DOES IT FIT INTO THE TRADITIONAL
MODEL OF HEALTH CARE DELIVERY
AND WHERE'S PREVENTION IN ALL
TH
THIS.
>> GREAT QUESTION AND WE WERE
THINKING OF HOW TO BRING UP
REGULATORY ASPECTS AND WE CAN
BLAME BRUCE FOR BRINGING IT UP.
>> YOU USE WORDS QUICK AND I
THINK FOR TECHNOLOGY DEVELOPMENT
THAT'S IT'S HARD TO GET A
REGULATORY PACKAGE THROUGH AND
REVIEWED AND GO TO MARKET.
IT'S HARD TO MAKE THOSE THINGS
QUICK AND PUTTING ON THE
REGULATORY HAT.
THE EMERGENCY USE PATHWAY IS
DIFFERENT FROM THE FULL
AUTHORIZATION PATHWAY.
IN THE NEXT PANEL I'LL GO
THROUGH THIS IN MORE DETAIL BUT
IT COMES DOWN TO RISK AND WHAT
THE NEED IS AT THE TIME.
AND WHAT IS ACCEPTABLE FOR A
HOME TEST VERSUS NOT AND THINK
WHAT IS THE USE CASE HERE?
TYPICALLY WITH A FULL
AUTHORIZATION PATH YOU'RE
TALKING ABOUT AN INDIVIDUAL.
WHAT IS THEIR TREATMENT AND HOW
SENSITIVE IS IT FOR THEM.
THE REASON WE WERE USING A LOT
OF THE HOME TESTS IS FOR THE
POPULATION MODEL AND THAT'S NEW
TO THAT BROAD AND WIDE SCALE YOU
MENTIONED.
SOMETHING TO THINK ABOUT.
I THINK THE REGULATORY MIND SET
NOW CONSIDERS BOTH AND WOULD BE
GREAT TO BE ABLE TO PAVE NEW
PATHS AND MAKING IT CLEAR THIS
IS SOMETHING DESIGN FOR PUBLIC
HEALTH AND INDIVIDUAL MEDICAL
CARE.
IT'S NOT A SIMPLE QUESTION.
BACK TO THE BEGINNING WITH OUR
DIRECTOR AND GET PEOPLE INVOLVED
IN THEIR OWN HEALTH CARE IS
SOMETHING I'M PERSONAL TRYING TO
WORK THROUGH WITH MY COMPANY.
WE HAVE A D TO C WELLNESS TOOL
AND YOU'D LIKE TO TELL PEOPLE IF
YOU START PREVENTING NOW YOU CAN
PREVENT THIS LATER.
HAVING THE EDUCATIONAL PIECE
PROVES TO BE VALUABLE AND
FIGURING OUT WHAT YOU CAN AND
CAN'T SAY FROM A REGULATORY
PERSPECTIVE HAS PROVEN TO BE A
CHALLENGE AND SOMETHING I'M
WORKING ON PERSONALLY FOR OUR
COMPANY AND AS A PROFESSIONAL.
I THINK THE MIND SET WE HAD
GOING INTO THE CONVERSATION THE
TESTING BECAME SO UNIVERSAL SO
QUICKLY EVERYBODY KNEW HOW TO DO
A TEST.
COULD WE MAKE IT SIMILAR FOR ING
PEOPLE ABOUT HEALTH AND WHAT
THEY SHOULD BE DOING SIMILAR TO
CHECKING BLOOD PRESSURE AND
WALKING 10 ,000 STEPS A DAY.
THERE HAS TO BE MORE THERE AND
THE SHORT ANSWER WOULD BE
GETTING THE EDUCATION AND
ENGAGEMENT OUT THERE AND
FIGURING OUT IN THE CONTEXT OF
REGULATORY HOW TO MAKE IT ALL
WORK IN ORDER TO PUT THAT
MISSION FORWARD.
>> IT'S GREAT QUESTION.
ANYTHING WE CAN DO TO HELP THE
PROCESS WE'D BE HAPPY TO SIT
DOWN AND HAVE THE CONVERSATIONS
BECAUSE THIS IS THE BIGGEST
VARIABLE IF IT'S POSSIBLE TO
MEASURE LOD RATHER THAN
SPECIFICITY AND RELATIVE
MEASURES AND HOW ELSE DO TESTS
ORDERS OF MAGNITUDE DIFFERENT IN
LOD HAVE 95% SPECIFICITY.
WHAT'S THE METRIC?
THAT'S A HEAD-SCRATCHER FOR ME.
MAYBE THERE ARE THINGS WE CAN
SIT DOWN AND DISCUSS AND MAKE
WORK A LITTLE BIT BETTER.
>> IT WILL FALL UNDER FDA
OVERSIGHT.
SO BACK TO THE INVESTOR THING,
THAT'S ANOTHER BAR THAT HAS TO
BE CROSSED BEFORE A PRODUCT IS
ON THE MARKET AND BEFORE IT CAN
START GENERATING ANY R.
TO GET PROLIFERATION OF
TECHNOLOGIES OUT THERE TO
ADDRESS UNMET MEDICAL NEEDS, A
HUGE WAY TO ACCELERATE THAT IS
TO LOWER THE RISK ASSOCIATED
WITH THAT.
THE CLARITY IN IT.
INCREASE THE SPEED IN WHICH
CLARITY CAN BE REEFED.
-- REEFED -- REACHED.
THOSE ARE DEFINITELY VERY TASTY
FRUIT THAT CAN HELP THE START-UP
GROW UP TO A STRONG ADULT.
I WOULD HEAVILY ADVOCACY FOR
THAT.
THE EUA WAS GREAT.
HERE'S A TEMPLATE THAT LAID OUT
THE THINGS YOU NEEDED TO DO.
TOWN HALLS TOOK PLACE ON A
WEEKLY BASIS AND AND ALLOWS
COMPANY TO ENTER SPACE THEY
WOULDN'T HAVE OTHERWISE AND
THAT'S WHAT THE THING WAS DESIGN
TO DO.
THAT DEMONSTRATED THE POWER OF
AN ACCELERATED AND POTENTIALLY
MORE CLEAR FOR FOLKS -- IF WE DO
THESE THINGS AND HIT THE
OUTCOMES, GOOD THINGS WILL
HAPPEN, THAT'S HELPFUL AND
MAKING IT MORE TRANSPARENCY.
BEFORE REGULATORY SEEMS LIKE A
BIG R FOR SOMEONE FROM THE
TECHNOLOGY SIDE.
I KNOW IT'S OBVIOUSLY NOT THE
CASE BUT FURTHER TRANSPARENCY ON
THE FRONT HELPS THOUGHT JUST
HELP THE REGULATORY STUFF.
>> ONE MORE AND FOLLOW UP.
>> IN OTC USE CASE, IF IT'S JUST
AN OTC USE CASE WHERE IT'S A
PERSON IN THEIR HOUSE, WE HAVE
TO BE CLEAR IT WOULD BE
SYSTEMATIC PATIENTS AND THEY'LL
INCREASE THE PRE-TEST
PROBABILITY TO FAVOR NOT HAVING
A FALSE POSITIVE.
TO THE PUBLIC HEALTH USE CASE
THOUGH YOU MIGHT ACCEPT SLIGHTLY
DIFFERENT PARAMETERS IN ORDER TO
TRY TO GET AT OTHER SYNDEMICS WE
HAVE NOW.
I PARTICULARLY CASE ABOUT THE
STI SPACE BUT IT'S IMPORTANT TO
HAVE A DISTINCTION.
HOW DO YOU ALL FEEL ABOUT HAVING
AN OTC PUBLIC HEALTH USE CASE
AND HAVING THE FDA HAVE A
PATHWAY FOR THAT?
WHERE IT CAN YOU REALLY IMPACT
HOW MUCH CHLAMYDIA WE HAVE FOR
EXAMPLE.
>> YOU MENTIONED THE SENSITIVITY
OF A TEST NOT TAKING ZERO
PERCENT AND IT'S SUPER TRUE.
I WOULD SUPPORT THAT TO IMPROVE
PUBLIC HEALTH.
ABSOLUTELY.
>> I THINK EXPLAINING WHAT THE
CONTEXT WOULD BE IS IMPORTANT
AND WHAT WE'RE SEEING IN
ULTIMATE LABELLING LIKE FINE
PRINT ON HOW TO USE IT MAY NOT
BE THE BEST WAY TO GET THE
EDUCATION ACROSS.
SOME COMPANIES INDIVIDUALLY WERE
TALKING HOW TO DO THINGS AND
SIMPLIFYING A LOT OF THE
LANGUAGE TO TIE INTO THE ONGOING
INITIATIVES I KNOW PEOPLE ARE
HERE FROM THEM AND MAKING THINGS
MORE ACCESSIBLE EVEN FROM A
DIGESTION PERSPECTIVE OF WHAT
YOU'RE SUPPOSING TO DOING WITH
THE RESULT IS ONE ANGLE AND
BRUCE MENTIONED THE BAR YOU'RE
MEETING WE'LL CALL IT ON THE
SENSITIVITY AND SPECIFICITY
SIDE, WE'RE VERY DIFFERENT BUT I
DO THINK THE NPA HAS HELD A HIGH
BAR.
IF YOU'RE GOING TO SACRIFICE
YOUR SENSITIVITY, THERE'S GOING
TO BE NO MISSES ON THE
SPECIFICITY SIDE.
YOU WON'T HAVE FALSE POSITIVES
COMING OUT AND TAKING A POSITION
FROM THE REGULATORY SIDE AND
HAVING THAT AS A STANDARD ACROSS
ALL DEVICES I THINK DID HELP.
WHEN A TEST CAME BACK POSITIVE
YOU WERE CERTAIN YOU WERE GOING
TO BE POSITIVE.
THERE WERE SOME THINGS DONE WELL
AND IT'S NOT AN EASY QUESTION
BUT THEY'RE CONTINUING EFFORTS
AND TIES INTO ENGAGEMENT AND
EDUCATION ON WHAT YOU SHOULD BE
DOING WITH THE TESTS.
>> IN THE NEAR FUTURE AND IT'S
HAPPENING NOW, THERE'S GOING TO
BE A BLURRING OF MEDICAL
DIAGNOSTICS WITH A CONSUMER
PRODUCT AND WE WERE TALKING
ABOUT THIS FROM THE POC AND
DTCs.
CAN YOU TALK ABOUT THE
CHALLENGES WHEN YOU'RE TRYING TO
MAKE A MEDICAL DEVICE AND
SUDDENLY IT'S A CONSUMER PRODUCT
ON AMAZON TALKING ABOUT THE
COMPANY'S STRATEGIES AND
CHALLENGES YOU GUYS HAVE FACED
AND BEING FORWARD LOOKING AS
WELL.
FEEL FREE.
>>
>> HUMAN FACTOR IS KEY AND WE
WERE FORTUNATE ENOUGH TO FIND
SOMEBODY WHO WAS THE PRODUCT
GURU AT PROCTER& GAMBLE WOULD
JOINED US AND WE IT RATED THE
PRODUCT -- ITERATED THE PRODUCT
AND COULD BE INTERPRETED IN
OTHER LANGUAGES AND THE RESULTS
WERE EASY TO INTERPRET AND ALL
TECHNOLOGIES START CENTRALIZED
AND BIG AND EVENTUALLY BECOME
DISSEMINATED AND SMALL AND
PERSONABLE.
IT'S COMING AND GOING TO HAPPEN.
>> I AGREE WITH EVERYTHING YOU
SAID, ERIK.
TO ADD ON I THINK THERE'S
BENEFITS WHEN YOU DESIGN A
PRODUCT FOR AN END USER WHO IS A
LAY USER.
THAT'S WHO WITH YOU WERE
TARGETING.
WE DID SOMETHING SIMILAR AND HOW
SOMEONE WITH ZERO BACKGROUND CAN
SCREW UP SOMETHING THAT IS SCREW
UPABLE AND YOU CAN SOLVE THOSE
THINGS AND THE PRODUCT NOT ONLY
GOOD FOR THE USERS BUT CAN
BENEFIT IN PROFESSIONAL
SETTINGS.
PUSHING THE ENVELOPE ON
ACCESSIBILITY IS IN GENERAL A
REALLY GOOD THING.
THERE'S SOME WHACKY STUFF.
MENTIONED AMAZON AND YOU GET TO
SEE REVIEWS AND PEOPLE POSTING
ON TWITTER AND IT'S A WEIRD NEW
WORLD OF HOW PEOPLE INTERACT
WITH THE MARKET POSTMARKET AND
INSIGHT YOU NORMALLY WOULDN'T BE
ABLE TO DO AS A MEDICAL DEVICE
COMPANY.
IT'S LIKE A CONSUMER ELECTRONICS
COMPANY.
I THINK WE SHOULD KEEP PUSHING
IN THE DIRECTION.
IT'S CLEARLY WORKING.
AS AN ANECDOTE I'M WEARING A
CONTINUOUS GLUCOSE MONITORING SO
UNDERSTAND HOW WHEN I EAT
AFFECTS ME IS IT INFLUENCING MY
BEHAVIOR IN A WAY THAT'S MORE
HEALTHY?
I HAD TO GET A PRESCRIPTION FROM
MY DOCTOR TO GET IT BUT IT'S
CLEARLY A GOOD THING.
I DON'T KNOW WHAT THE RIGHT
ANSWER IS BUT I HOPE WE CAN KEEP
PUSHING AND MORE INFORMATION
WILL CONTINUE TO EMERGE.
>> SPECIFIC CHALLENGE WITH
THINKING ABOUT A PRODUCT HOW IT
EVOLVES FROM A CENTRAL SPACE TO
BEHIND THE COUNTER IS HOW YOU
MARKET IT AND IF THERE'S
OPPORTUNITIES TO PARTICIPATE IN
ONE OR MORE AT ONE TIME AS A
SMALL OR LARGE COMPANY HOW
YOU'LL DO IT.
AND IF THERE'S GOING TO BE OVER
TIME IT'S GOING TO HAPPEN AND
WE'RE CERTAINLY SEEING THE
OPPORTUNITY FOR OUR PRODUCTS.
DO I TAKE 10% OF MY BUDGET PUT
IT HERE AND 30% HERE AND PUSH
FORWARD.
AT THE SAME TIME YOU WOULD LIKE
AS POSSIBLE YOUR ENGAGEMENT IN
EDUCATION TO BE THE SAME MESSAGE
SO IF SOMEONE INTERACTS WITH YOU
IN THIS FORM IT'S NOT DIFFERENT
THAN THIS MARKET OVER HERE.
SO THAT IS ONE VERY REAL
GRANULAR CHALLENGE AND GRATEFUL
TO HAVE A FULL-PLEDGED MARKETING
DEPARTMENT TO HELP ME THROUGH
THE CHALLENGES BUT THERE'S OTHER
DIRECT TO CONSUMER PRODUCTS.
IF YOU WANT TO MAKE SURE IT
WORKS AND MAKE SURE THE
TECHNOLOGY'S THERE OF COURSE BUT
TO TAKE IT FURTHER, HUMAN
FACTORS, FIND OUT WHY PEOPLE
INTERACT WITH THINGS FOR FUN TO
PROMOTE THEIR ENGAGEMENT AND
GETTING INVOLVED.
ONE REAL THING AFTER DOING 2024
BUDGETS FOR OUR COMPANY.
>> ALL RIGHT.
THANK YOU SO MUCH.
>> IT SOUNDS LIKE THE PANEL
WE'VE ALL BEEN WAITING FOR,
REGULATORY.
SO WE WILL HAVE THIS PARTICULAR
PAN CHAIRED BY QI DUAN AND I'LL
LEAVE IT TO QI.
>> THANK YOU, EVERYONE.
I'M QI HERE TO FILL IN FOR MY
COLLEAGUE WHO PUT IN A LOT OF
EFFORT IN ORGANIZING THE PANEL
AND HONORED TO WORK WITH ALL THE
PANELISTS HERE.
AND THE TOPIC WHICH IS A PERFECT
SEGUE FROM THE DISCUSSION IS
FOCUSSING ON REGULATORY STANDARD
COMPLIANCE, WHICH I WILL ARGUE
IS AN AREA NOT WELL KNOWN BY
GENERAL PUBLIC AND CONVERTS TO
THE OTHER TWO TOPICS AND AS YOU
HEARD FROM THE PREVIOUS PANEL
AND DISCUSSION THERE'S HURDLES
GETTING THE TECHNOLOGY INTO THE
MARKET AND I WANT TO TAKE THE
OPPORTUNITY TO BRING IN ANOTHER
ASPECT REPEATED IS THAT IF YOU
LOOK AT THE SPACE FROM ALL THE
STAKEHOLDERS ARE THE GREAT
EFFORT TRYING TO ENSURE RELIABLE
TESTING CAN BE DELIVERED INTO ON
TIME.
WE HAVE THREE PANELISTS.
ONE TODAY AND EACH HAS A SHORT
PRESENTATION SO WITHOUT FURTHER
ADO, DR. HEETDERKS.
>> THANK YOU.
IT'S A REAL PLEASURE TO BE HERE
AND WE CAN START WITH THE FIRST
SLIDES BECAUSE I KNOW WE'RE
STANDING BETWEEN YOU AND LUNCH
AND THAT ALWAYS MAKES ONE WANT
TO HURRY UP A LITTLE BIT.
I WANT TO TALK A LITTLE BIT
ABOUT EVOLUTION EYE AND IN
PARTICULAR HOW OVER THE RAPID
ANTIGEN TESTS GOT REGULATED.
AND THE ONLY OTHER THING TO NOTE
ON THE INTRODUCTORY SLIDE IS I'M
AN ADVISER WHICH MEANS I'LL BE
ABLE TO SAY THINGS THAT ARE IN
NO WAY REPRESENTATIVE OF BEING
BINDING ON THE FDA OR NIH.
IF I SAY SOMETHING TO YOU AND
LATER YOU SAY, WELL, BILL YOU
SAID I'M SAYING THIS AS AN
ADVISER NOT AS AN OFFICIAL
SPOEKDZ PERSON FOR --
SPOKESPERSON FOR THE NIH.
WHEN WE FIRST STARTED THIS I
SENT AN E-MAIL TO I SENT AN
E-MAIL TO TIM AT THE SAYING WE
WANT TO COOPERATE AND
COLLABORATE ON THE ACTIVITY AND
HE WROTE BACK AND SAID
ABSOLUTELY.
IT'S A GREAT IDEA.
WE'LL BE JOINED AT THE HIP GOING
FORWARD ON THIS.
THAT STRUCK ME AS A GREAT IDEA
ALSO BUT IT BECAME CLEAR WE
WEREN'T AS JOINED AS I THOUGHT
WE WERE GOING TO BE.
WHEN YOU THINK ABOUT IT A LITTLE
BIT, WHEN YOU LOOK AT THE
MISSION YOU REALIZE WHY THAT WAS
TRUE.
FDA PROTECTING PUBLIC HEALTH,
SAVED AN EFFICACY AND NIH IS
SEEK FUNDAMENTAL KNOWLEDGE AND
APPLICATION OF THE KNOWLEDGE TO
ENHANCE HEALTH.
DIFFERENT MISSIONS.
WE HAVE DIFFERENT SPECIES JOINED
AT THE HIP WHICH DOESN'T MAKE
SENSE.
THAT ANALOGY BROKE DOWN BUT I
WANT TO INDICATE AND REALIZE WE
COULD WORK TOGETHER THOUGH WE
HAVE DIFFERENT MISSIONS.
AND WHAT YOU'RE LOOKING AT HERE
IS STUDIES THAT WERE DONE ON
PATIENTS WHERE ON THE X AXIS YOU
HAVE NASAL SWAB AND HOW MUCH
VIRUS IS PRESENT IN THE NASAL
SWAB FROM LOW TO HIGH VIRUS HERE
AND ON THE Y AXIS THE
PROBABILITY THE ANTIGEN TEST IS
IS GOING TO BE POSITIVE.
IT'S PRETTY OBVIOUS.
THESE ARE THREE DIFFERENT TESTS,
TWO ARE ALMOST COMPLETELY SUPER
IMPOSED MOVING FROM LOW VIRAL
LOAD TO HIGH VIRAL LOAD THE
PROBABILITY OF DETECTION GOES
WAY UP.
SO ALL THE ENGINEERING IN THE
AUDIENCE KNOW IF YOU'RE
OPERATING IN THIS REGION HERE
THOSE TESTS WILL WORK FANTAS
FANTASTICALLY AND IF YOU WORK
HERE THEY'LL DROP DOWN UNTIL IT
DROPS DOWN TO MAYBE 20% OR SO.
TAKE THAT CURB AND WHAT HAPPENS
TO YOU WHEN YOU GET THE COVID
INFECTION.
THIS IS REFERENCED TO TIME ZERO
OF THE PEAK LOAD.
IT GOES FROM LOW VIRUS TO HIGH
VIRUS BACK DOWN TO LOW VIRUS.
THE THING TO NOTE ON THIS IS
REALLY NOT THAT ENVELOPE BUT THE
SCALE ON THE Y AXIS WE'RE GOING
FROM 10 TO THE 0 TO 10 TO THE 9.
THIS RANGES OVER A BILLION FOLD
IF YOU DO THE ANTIGEN TESTS IN
THE REGION HERE YOU'LL BE IN
SHAPE.
ON THE OTHER HAND IF YOU TEST
HERE AT THE BEGINNING IT'S GOING
TO BE DIFFICULT AND YOU WON'T BE
ABLE TO TEST.
SO THIS SHOWS IT'S NOT JUST ONE
PATIENT BUT A LOT OF PATIENTS.
IN CONTRAST TO THAT, THAT'S THE
NIH AND WHAT WE FOUND AT NIH IF
YOU SWITCH OVER NOW TO FDA'S
PRODUCT REVIEW WHICH IS THIS
OTHER SPECIES THAT WE'RE TALKING
ABOUT, YOU START WITH DEVELOPING
AN INDICATION FOR USE AND GET
DESIGN FREEZE AND HAVE TO DO
ANALYTICAL STUDIES, STABILITY
STUDIES, ETCETERA.
DIFFERENT COMPANIES WILL SAY I
HAVE A PRODUCT BUT WHAT'S THE
PRODUCT.
AND ONE SAYS AGE 14 YEARS OR
OLDER AND ONE 15 ONE 15 AND 16
AND SYMPTOMS WITH SEVEN DAYS,
FIVE DAYS, FOUR DAYS.
SO I'LL ASK, ANY OF YOU IF YOU
HAVE A 14-YEAR-OLD WOULD YOU
SPECIFICALLY SAY I'M ONLY USE
THIS PRODUCT BECAUSE IT'S BEEN
CLEARED FOR 14-YEAR-OLDS OUT IF
YOU'RE THE FDA IT MAKES SENSE
BECAUSE THE STUY INCLUDED
14-YEAR-OLD AND LIKEWISE ON THE
DAY IT MAKES IT DIFFERENT.
YOU HAVE SOMEHOW WORK THOSE
TOGETHER AND WITH DISCUSSION AND
THIS IS WHERE I TITLED IT
EVOLUTION BECAUSE THIS HAPPENED
OVER TIME NOT OVER A DAY OR WEEK
BUT OVER A PERIOD OF MONTHS AND
YEARS.
AND I'LL HAVE TO SAY THAT HAVING
DR. TROMBERG SAYING YOU NEED A
CHAMPION AND WE HAD A CHAMPION
THERE AND THAT HELPED THINGS
ALONG.
THERE WAS A STANDARD THAT COULD
BE USED AND ALSO I'LL SKIP OVER
THIS A LITTLE BIT BECAUSE MY
TIME IS ZIPPING ALONG BUT A
LONGITUDINAL STUDY THAT ALLOWED
US TO COLLECT DATA THAT COULD BE
USED NOT JUST FOR ONE TEST BUT
FOR MULTIPLE TESTS.
WE HAVE STANDARDIZED IFU AND
I'LL HIGHLIGHT THE END PART AND
INDIVIDUALS WITHOUT SYMPTOMS.
THERE'S THE APPLICATION OF WHERE
YOU'RE SCREENING AND TESTING AT
LEAST THREE TIMES OVER FIVE
DAYS.
IF YOU LOOK AT THE INITIAL
CURVES I SHOWED YOU, IT'S VERY
OBVIOUS WHY FROM THE NIH SIDE
THE SCIENCE WAS POINTING THAT
WAY AND TALKING WITH THE FDA
THEN IF THE FDA GOT ON BOARD
WITH THAT, WE COULD DO THE
CLINICAL STUDIES AND AWAY WE
WENT.
AND THAT ACTUALLY WORKED.
ONE OTHER QUICK THING I WANT TO
TALK ABOUT IS NEED FOR SPEED.
EVEN WITH THAT, IT WASN'T QUITE
FAST ENOUGH.
A WHOLE OTHER APPROACH TO GET
THROUGH THE PROCESS MORE QUICKLY
THAT WAS INDEPENDENT TESTING.
THE PROGRAM ALREADY BRIEFLY
MENTIONED.
AGAIN THIS WAS COORDINATED AT
THE FDA AND NIH WHERE THEY
NEGOTIATED AND AGREED ON STUDY
DESIGNS AND FDA TELL ME WHAT YOU
WANT ME TO DO AND THAT'S WHAT
I'M GOING TO DO AND FDA WILL
ANSWER BACK, COMPANY, TELL ME
WHAT YOU'RE GOING TO DO AND I'LL
TELL YOU IF THAT'S ALL RIGHT.
AND ACCEPT THE DATA AS IT BECAME
AVAILABLE.
I LISTED ALL THE ITEMS THAT AND
CONSISTENT PROTOCOLS SO ALL THE
TESTS WERE BEING EVALUATED IN
THE SAME WAY AND AS A RESULT OF
THAT YOU COULD ACTUALLY MUCH
MORE REASONABLY CARE -- COMPARE
ONE TO THE OTHER AND SPED THINGS
UP TREMENDOUSLY.
TO SUMMARIZE, ORGANIZATIONS HAVE
TO RESPECT EACH OTHER'S MISSIONS
BUT CAN WORK TOGETHER FOR A
COMMON GOOD AND IT WORKED WELL
HERE.
THE OTHER THING AND IT CAN
SIMPLY AND ACCELERATE THE
APPROVAL PROCESS.
THIS IS SOMETHING THAT CLEARLY
WORKED WORKED WELL FOR THE COVID
TESTS AND INTEGRATING THE
INSIGHTS TO NORMAL OPERATIONS OF
NIH AND FDA CAN ENHANCE THE
ABILITY OF BOTH ORGANIZATIONS
FOR WHAT WE WERE CALLED TO DO BY
THE NIH DIRECTOR TO POSITIVELY
IMPACT HUMAN HEALTH.
THAT'S OBVIOUSLY AN ASPIRATIONAL
GOAL.
BUT I THINK IT'S SOMETHING THAT
IS ONE OF THE REALLY GREAT
MESSAGES FROM THE RADX PROGRAM
THAT WE CAN TAKE HOME.
SO I WILL TRANSFER OVER NOW TO
THE NEXT SPEAKER.
THANKS.
>> OKAY.
I THINK YOU SAID -- SET THE TALK
UP REALLY WELL.
I WANT TO THANK THE ORGANIZERS
FOR GIVING ME THE OPPORTUNITY TO
PRESENT TODAY.
I'M GOING TO TALK ABOUT WORK WE
DO IN THE LAB AND TALK HOW
TESTING HAS IMPACT ED OUR LAB
TESTING TEST THE TESTING
LANDSCAPE AS WELL AS THE
INFLUENCE ON REGULATORY
STANDARDS COMPLIANCE.
SO AT THE CENTER WHENEVER WE GET
A COVID-19 TEST WE FOLLOW A
MULTI-FACETED APPROACH WE CALL
TESTING THE TESTS.
WE HAVE THE PATHOLOGISTS AND THE
CHILDREN'S HEALTH CARE OF
ATLANTA AND THE CLINICAL
LABORATORIES AND BIO ROW POS
TRIES.
THE -- REPOSITORIES.
THE FIELD STUDIES ARE PROSPECTED
BY OVER THE COUNTER DEVICES
TESTED HERE BY THEM.
THEY HAVE THE ENGINEERS DOING
ADDITIONAL ASSESSMENT INCLUDING
BUT NOT LIMITED TO TEST
AVAILABILITY.
WHAT I'LL FOCUS ON TODAY IS
TESTING THAT IS IN THE LAB AT
EMORY UNIVERSITY, WE HAVE
SEVERAL BIO SAFETY LEVEL 2 AND 3
LABS.
WE DO RIGOROUS AND DETAILED
TESTING OF DEVICES IN THESE
LABS.
WE ALSO HAVE CAN PROPAGATE
VIRUSES AND USE THEM FOR
TESTING.
AND ALONG WITH LABORATORY
TESTING OF DEVICES WE'RE ALSO
DEEPLY INVOLVED IN PROTOCOL
INVOLVEMENT.
I WANT TO TALK ABOUT HOW THE
TESTS WORK.
WE USE CONTRITE SAMPLES AND IT'S
BEEN MENTIONED WE DO LIMITED
DETECTION MEASUREMENTS AND FOR
THIS WE USE LAB PROPAGATED VIRUS
AND WE TAKE THIS AND THEN WE
ACTUALLY SERIALLY DILUTE THEM IN
A COMMERCIALLY AVAILABLE USUALLY
NEGATIVE NASAL WASH AND THEN
HAVE THIS TEST USING THE GET A
SENSITIVITY OF TARGET AND THE
SAMPLES ARE LEFT OVER AFTER
CLINICAL TESTING.
WE GET THESE -- WE TAKE HIGHLY
CONCENTRATED SAMPLES AND DILUTE
THEM IN MATRIX AND THE BEAUTY OF
RCS TESTING IS THEY CLOSELY
MIMIC CLINICAL SAMPLES AND THE
RESULTS WILL GIVE A GOOD ITE YA
OF HOW A TEST WILL DO IN REAL
LIFE.
THE WEN EXPRESS RESULTS AND ONCE
THESE TWO TYPES OF SAMPLES ARE
READY, WE THEN SET UP ASSAYS AND
I'LL ELABORATE ON THIS LATER ON
IN MY TALK AND WE HAVE AN
EXTENSIVE BIO REPOSITORY AT
EMORY.
THIS IS FOR EMORY SAMPLES BUT
ALSO WE GOT THIS AS THE RESULT
OF WORKING CLOSELY TOGETHER WITH
THE TASK FORCE.
WE HAVE LIVE AND ADAPTIVE SARS
COV2 SAMPLES AND I WANT TO POINT
OUT THEY'RE EXPANSIVELY
SEQUENCED AND KNOW THE FULL
SEQUENCE OF THE SAMPLES AND WE
KNOW WHICH SUBVARIANT THEY ARE.
WE ALSO HAVE A BIO REPOSITORY A
LIVE FLU A AND B AND RSV SAMPLES
AND ALSO LIVE SAMPLES.
AS FAR AS METHODOLOGY WE HAVE A
FIXED FOL UME USUALLY 50
MICROLITERS AND ALL THE SAMPLES
ARE DILUTED AN COMMON MATRIX AND
ALLOWS TEST TO TEST COMPARISON.
SO WHAT I'M GOING TO TALK ABOUT
AND THE ROLE OF ASSAYS IN THE
TESTING LANDSCAPE AND TOUCH UPON
CONTROLLED ANALYSIS AND EPITOPE
MAPPING BUT WILL GO OVER THIS
BRIEFLY BECAUSE THESE HAVE BEEN
RECENTLY PUBLISHED AND ALL THE
DETAILS ARE AVAILABLE ONLINE.
I'M GOING TO END WITH AN EXAMPLE
OF HOW RAPID TESTING OF A
VARIANT WAS MADE POSSIBLE
BECAUSE OF OUR EXTENSIVE BIO
REPOSITORY.
I WANT TO TALK ABOUT THE
DEVELOPMENT OF THESE BOOKEND
ASSAYS.
WE WANTED TO DEVELOP A PROCESS
WE COULD USE TO FOR APPLES TO
APPLES COMPARISON OF TESTS.
FOR THAT PURPOSE WE CAME UP WITH
THIS CONCEPT OF BOOKEND ASSAYS
TO DEFINE THE TEST PERFORMANCE.
SHOWN HERE IS A DATA SET THAT
WAS GENERATED IN THE LAB.
WE TOOK A POOL OF SAMPLES THAT
WAS RCS SAMPLES AND HAD A HIGHLY
CONCENTRATED POOL WE THEN DID A
DELETION SET AND WE GOT VALUES
AND DID DIGITAL DROP LET PCR FOR
VARIANTS AND TESTED ALL THE
SAMPLES AND GET THE PROTEIN IN
THE SAMPLE.
AFTER THE EXTENSIVE QUALITY
CONTROL THE TESTERS IN
CONCENTRATED SAMPLE OR NEGATIVE
CONTROL AND WE TESTED ON THE
BOOKEND ASSAYS.
THESE ARE TWO ANTIGEN ASSAYS
WITH UA AND HAVE BEEN APPROVED
BY THE FDA FOR USE AS BOOKENDS.
WE THEN WOULD BE -- AS SOON AS
WE TEST THIS WE BASICALLY
ESTABLISHED THE TWO TESTS.
THE RESULTS OF THE TESTS
BASICALLY DEFINE ANY NEW TEST
BOUNDARY OF PERFORMANCE.
ANY NEW TEST AND HOPE THE TEST
DOES AT LEAST AS WELL AS THE
LOWER PERFORMING BOOK END AND
HISTORICALLY WE HAVE SEEN THAT
ANY TESTS THAT PERFORMS HAS A
HARD TIME OF OBTAINING EUA AND
THIS TYPE OF APPLES TO APPLES
COMPARISON IS A NOVEL
DEVELOPMENT AND AS FAR AS I KNOW
HAS NOT BEEN USED AT THIS SCALE
PREVIOUSLY.
AND PORTIONS HAVE MADE IT INTO
DATA ADDED TO PACKAGES.
STAYING ON THE TOPIC OF BOOK END
ASSAYS AND TESTS THAT PROCEED TO
FIELD CLINICAL TESTING.
THIS DATA SLIDE IN MY PREVIOUS
TWO SLIDES IS JUST A LITTLE BIT
MORE ELABORATED HERE AND I'VE
ADDED IN DATA FROM 12 TESTS.
IF YOU LOOK FROM LEFT TO RIGHT
IT'S LEAST SENSITIVE TO MOST
SENSITIVE.
THE FIRST THREE TESTS PERFORMED
LESS WELL THAN THE LOWER BOOKEND
AND USUALLY WHEN WE SEE THIS WE
KNOW IT'S A LOW PERFORMING TEST
AND LET THE DEVICE MANUFACTURER
KNOW THE TEST NEED TO BE
OPTIMIZED MORE.
AND THE DEVICE MANUFACTURE ENDS
UP REFORMATTING IT AND OFTEN
COMES BACK IN A MUCH BETTER
FORMAT.
THE LOW-PERFORMING TESTS DON'T
PROCEED TO FIELD TESTING OR
CLINICAL STUDIOS AND ACTUALLY
THIS SAVES TIME AND MONEY.
HOWEVER, MOST THE TESTS FALL
BETWEEN THE TWO BOOK ENDS AND
SOME TESTS ACTUALLY DO BETTER
AND THEY PROCEED TO CLINICAL
TRIALS AND TO EUA.
WE'VE PERFORMED SIMILAR TABLES
WITH LAB-PROPAGATED VIRUS.
AND ONE THING I WANT TO POINT
OUT IS THERE'S EXCELLENCE
CORRELATION BETWEEN OUR DATA
WITH CLINICAL STUDIES OUTCOME
AND BY THE METHOD OF LAB TESTING
WE SAVED MILLIONS OF DOLLARS
BECAUSE LESS OPTIMIZED TESTS
DON'T ENTER INTO CLINICAL
TRIALS.
I MAY HAVE TO SKIP OVER THESE
AND I CAN ELABORATE ON THIS TO
ANYONE INTERESTED LATER ON.
BUT THESE ARE THE TWO THINGS
THAT HAVE BEEN PUBLISHED SO
THEY'RE AVAILABLE ONLINE AND
THIS SLIDE AND WHAT I WANTED TO
COVER WAS COMPARED TO CALIBRATED
ENABLED EUAs WHERE BASICALLY THE
4944 WAS ESTABLISHED TO BE A
LO
LOW-POSITIVE CUT-OFF FOR SEVEN
COMPANIES AS OF SEPTEMBER TO
OBTAIN EUA.
AND IS WAY TO GENERATE ALL
POSSIBLE MUTATIONS OF THE
NUCLEOCAPSID AND ANALYZE
INTERACTIONS IN ONE SINGLE
EXPERIMENT.
THE BEAUTY OF THE TECHNIQUE IS
IT MEASURES THE INTERACTIONS IN
THE CONTEXT OF PROTEIN AND SINCE
ALL MUTATIONS ARE COVERED IT
COVERS ANY POTENTIAL FUTURE
MUTATIONS THAT CANNOT GO AS
WELL.
IF YOU'RE ANTIBODY IS MAPPED IF
THERE'S A FUTURE MUTATION OF
CONCERN THE COMPANY WILL JUST
HAVE TO LOOK IN THE DATABASE AND
CHECK TO SEE IF THE MUTATION
ACTUALLY CAUSES AN ESCAPE IN
DETECTION.
AND WORKING WITH A DIAGNOSTICS
LAB WE HAD A SAMPLE SHIPPED IN A
BIO REPOSITORY EARLY IN
SEPTEMBER THE PCR ASSAY ARRIVED
IN OUR LAB AND THE SAME DAY THEY
WERE ABLE TO TEST IT USING THE
SAMPLE AND FOUND IT DETECTED THE
LOW CD.
THE NEXT DAY WE CARRIED OUT THE
DILUTION AND WE CARRIED OUT
CONTROL AND EQUAL VARIANT
DETECTION.
BECAUSE WE HAD ACCESS TO THE BIO
REPOSITORY IT WAS ABLE TO
RESPOND RAPIDLY WITHIN 10 DAYS
AND FOUND THE NEW VARIANT COULD
BE DETECTED BY THE PCR.
TO SUMMARIZE AND CONCLUDE I WANT
TO POINT OUT THE LAB CARRIES OUT
COMPLETELY INDEPENDENT
ASSESSMENT OF TESTS AND WE HAVE
DEVELOPED ASPECTS SUCH AS
BOOKEND ASSAYS AND UNIFORM
ASSAYS THAT ENABLES APPLES TO
APPLES COMPARISON AND SAVED
RESOURCES AND CREATED EFFICIENCY
AND CAN DETECT EARLY AND THE
TEST CAN GO BACK FOR
OPTIMIZATION.
SO BASICALLY THE LESS THAN
OPTIMAL TESTS DON'T ENTER
CLINICAL STUDIES AND I CAN'T
STRESS HOW MUCH BIO BANKING IS
IMPORTANT AND APPLY COVID
TESTING TO OTHER DIAGNOSTIC
TESTS.
WE'RE TESTING A COLD/FLU COMBO
ASSAYS AND TEXTING POX AND OUR
CORE HAS A UNIQUE ROLE IN THE
TESTING LANDSCAPE AND OTHER
CONTINUES COLLABORATION WITH NIH
AND FDA IS CRUCIAL.
AND OF COURSE NONE OF THIS WORK
WOULD BE POSSIBLE WITHOUT ALL
THE TEAM OF COURSE BUT ALSO ALL
THE EXCELLENT COLLABORATORS
WE'VE HAD THE OPPORTUNITY TO
WORK WITH.
>> I'M SEEING THE GUY BEHIND THE
CURTAIN RIGHT NOW.
ALL RIGHT.
SO I'M GOING PULL A DIFFERENT
HAT FROM THE LAST PANEL.
I HAD A HUGE ROLE IN THE
REGULATORY CORE FOR RADX SINCE
ITS INCEPTION AND THE I TAP
PROGRAM AND WANTED TO HIGHLIGHT
A FEW OF THE THINGS THAT WE WERE
OFTEN EDUCATING THE COMPANIES
ENTERING THE PROGRAM.
WE HAD THE WAY IT STARTS WE HAD
A PUBLIC HEALTH EMERGENCY
RAPIDLY SPREADING ACROSS THE
GLOBE AND OUR GOVERNMENT
DETERMINED THIS WAS NOW A PUBLIC
HEALTH EMERGENCY STARTING THE
PATH OR EUAs.
WE HAD TO STEP BACK AND LOOK AT
WHY ARE WE DOING THIS PATH?
TIME IS A VERY IMPORTANT FACTOR
AND I WANT TO HIGHLIGHT THE
DOMINO EFFECT YOU HAD A NEW
VIRUS EMERGING AND SPREADING
RAPIDLY AND HAD AN EXPONENTIAL
INCREASE IN DEMAND AND IT WAS
NOT MANAGED.
IT COULDN'T BE MANAGED.
WE ALSO HAD DEMAND FOR NEW
TESTS.
MARKERS AND PROBES AND
ANTIBODIES THAT HAVE NOT BEEN
STUDIED BEFORE.
WHAT THIS LEADS TO IS A SHORTAGE
OF TRADITIONAL SUPPLIES AND THE
SAME SHORTAGE OF SUPPLIES ALSO
CAUSED SLOWER ASSAY DEVELOPMENT
BECAUSE YOU HAD TEAMS TRYING TO
USE MACHINERY AND RE-AGENTS
ALREADY IN PLACE BUT EVERYTHING
WAS TAKING FROM THE PILES.
IT SLOWED NEW ASSAY DEVELOPMENT
AS WELL WHICH SLOWED
MANUFACTURING.
YOU START TO THINK OF WHAT ARE
ALTERNATE SUPPLIES I CAN USE AND
WHAT THAT EVENTUALLY LED TO WAS
ALTERNATE TEST METHODS AND
ALTERNATE SAMPLE TYPES.
IN AN EMERGENCY USE
AUTHORIZATION IT'S NOT A
FULL-BLOWN VALIDATION OF SAFETY
AND ADVOCACY.
IT'S PLASTERED OVER THE LABELS
BUT SEMBLANCE OF THE TECHNOLOGY
WORKS AND AS INTENDED.
I DON'T NEED TO READ ALL THIS
OUT.
THE DIFFERENCE BETWEEN EUA AND
THE VALIDATION OF AN ASSAY IN
THE CONTEXT OF SAFETY AND
EFFICACY BUT THE AGENCY IS
TAKING INTO CONSIDERATION TIMING
AND SHORTAGES ON THEIR CALCULUS
IN MAKING THE DECISION.
THROUGH THE PROGRAMS, WE WERE
ABLE TO STREAMLINE OUTSIDE THE
REGULATORY STORIES DESIGN TO
SUPPORT SUBMISSIONS.
WE WERE ABLE TO USE THAT ON THE
FRONT LINES AND LOOK UNDER THE
HOOD AND COMPARE AND IDENTIFY
PROTOCOLS FOR ANALYTICAL STUDIES
AS POSSIBLE FOR THE DEVICES THAT
MADE IT THROUGH THOSE BARRIERS.
THAT LED TO MORE RAPID REVIEW
TIMES.
IT WAS LOCKSTEP ATTACHED TO THE
HIP AS YOU SAID, BILL, NORD TO
MOVE IT FORWARD.
WE WERE ALSO ABLE TO DEAL WITH
THE POST-MARKET REQUIREMENTS FOR
THE COMPANIES.
UP SHORT OUR AIM WAS TO HELP THE
EUA SUBMISSIONS THROUGH AND HELP
IN ANY WAY WE COULD TO
FACILITATE THAT WE INTERFACED
WITH FDA WEEKLY, SOMETIMES MORE
THAN THAT AT THE HEIGHT OF THE
PANDEMIC WHICH I WAS
APPRECIATIVE OF AND INTERFACED
WITH OUR COLLEAGUES AT CMS AND
CLIA QUESTIONS THAT CAME ONLINE.
THIS IS MY FINAL SLIDE AND WHAT
I LEARNED IN WORKING WITH 20,
30, RADX COMPANIES.
THE PORTFOLIO WAS DESIGN TO
INCLUDE MANY APPROACHES AS PER
THE MISSION OF NIH, ACCEPTABLE.
WE LOOKED AT NOVEL SAMPLE TYPES
AND USE SETTINGS.
A LOT OF THE TESTING WAS IN A
HIGH COMPLEXITY LAB WITH
AUTOMATION AND ROBOTS FOR ONLY
PCR.
WE HAD A NUMBER OF TECHNOLOGIES
THAT USED DIFFERENT THINGS.
AN CREATES CHALLENGES AND IN AN
EXAMPLE, SALIVA WAS TOUTED AS A
SOLUTION AND IN MANY OF THE
COMPANIES I'D SPEAK TO THERE'S
EXCITEMENT ABOUT IT AND YOU WANT
TO MOVE FAST AND IT WORKS AND
IT'S NON-INVASIVE BUT THERE'S
THINGS YOU HAVE TO THINK ABOUT.
WHEN IS VIRUS OR ANTIGEN PRESENT
IN THE SAMPLE TYPE?
IS IT STRONG OR AS MUCH AND
LOOKING AT THE CURVES, BILL WAS
SHOWING, IT'S DIFFERENT FOR
EVERY SAME SAMPLE TYPE AND
LOOKING AT INTERFERENCE AND FLEX
STUDIES.
WHAT IF SOMEBODY USES COFFEE FOR
MOUTH WASH.
THERE WERE CHALLENGES IN THAT
THERE WERE MORE STUDIES THE
COMPANIES ANTICIPATED.
BUT IN WORKING WITH FDA I THINK
THERE'S GREAT TEMPLATES AND LIST
OF INTERFERING SUBJECTS YOU
SHOULD TEST FOR A SALIVA OR
SAMPLE TEST AND THE
STANDARDIZATION HELPED PROVIDE
APPLES TO APPLES COMPARISON
WHICH FOR ME IS VERY IMPORTANT
BECAUSE AS AN ENGINEER AT MY
CORE THE LESS VARIABLES YOU HAVE
THE BETTER THE MORE YOU CAN
LEARN FROM A STUDY.
IF YOU HAD UNIVERSAL ANYTHING
YOU HAD YOUR GROUND ZERO AND
WERE CHANGING ONE HOPEFULLY AND
A MINIMAL NUMBER OF VARIABLES
WHICH ENABLED THE COMPARISON.
IF THERE'S TIME, HAPPY TO TAKE
QUESTIONS.
>> THANK YOU.
UNFORTUNATELY WE ARE RUNNING OUT
OF TIME.
LET'S GIVE ANOTHER ROUND OF
APPLAUSE FOR THE WONDERFUL
PANELISTS.
AND PASS IT TO MY COLLEAGUE,
TIFFANI.
>>
>> THANK YOU ALL AND HOPEFULLY
YOU'LL ALL STAY THROUGH LUNCH
AND THE REST OF THE DAY HERE.
WE DO HAVE LUNCH.
IT IS IN THE CAFETERIA.
SO WE HAVE ABOUT AN HOUR BREAK
SO PLEASE MEET US IN THE
CAFETERIA OUT TO YOUR LEFT AND
UP THE STEPS. THANK YOU.
WE'RE GOING TO GETS STARTED
AGAIN.
WE HAVE A VERY EXCITING
AFTERNOON HERE.
SO WE ARE GOING TO START WITH
OUR DISTINGUISHED PANEL --
ACTUALLY A FORUM THIS TIME
CALLED RESEARCH AND INCH
V EGES -- INNOVATION HOT TOPICS,
LET BY TAYLOR GILLILAND,
CHAIRING THE PANEL.
>> GOOD AFTERNOON.
I'M TAYLOR GILLILAND, OFFICE OF
DIRECTOR NIBIB, HONORED TO BE
CHAIRING THIS PANEL.
AS WE GET STARTED I DID LIKE
TO -- WOULD LIKE TO ECHO
COMMENTS WE HEARD THIS MORNING
FROM THE NIH DIRECTOR, AND NIBIB
DIRECTOR.
IT'S A TRUE TESTAMENT TO POCTRN,
RADx TECH AND OTHERS TO HEAR
THE NIH DIRECTOR LESS THAN THREE
WEEKS INTO THE JOBS ALREADY
RECOGNIZING THE VALUE OF THE
WORK THAT WE DO.
AND THE IMPORTANCE OF POINT OF
CARE, HOME-BASED DIAGNOSTIC
TECHNOLOGIES.
SHE EMPHASIZED HOW WE MOVING
DIRECTLY INTO THE HANDS OF THE
PUBLIC, EFFORTS BRINGING
AWARENESS OF IMMEDIACY OF THE
IMPACT OF NIH INVESTMENTS ON
PUBLIC HEALTH.
WE'RE EMPOWERING INDIVIDUALS
WITH INFORMATION THEY NEED TO
MANAGE THEIR HEALTH AND LEAD
HEALTHY LIVES.
YOU HEARD DR. TROMBERG DESCRIBE
HOW THE COVID-19 PANDEMIC HAS
TRANSFORMED CERTAIN WAYS NIH AND
CERTAINLY NIBIB APPROACH
CATALYZING BIOMEDICAL
ILLUSTRATION, WITH OUR
INVESTMENT IN POCTRN AND RADx
TECH, A DRAMATIC SUCCESS.
THEY BROUGHT DOZENS OF NEW
TESTING PLATFORMS AND BILLIONS
OF NEW TESTS TO MARKET.
ENABLED MASSIVE SHIFT TO A MORE
DISTRIBUTED AND HOME-BASED
TESTING ONE WHERE EFFORTS
CONTINUE TO RIPPLE THROUGH THE
DIAGNOSTIC INDUSTRY, AGAIN AS
DR. TROMBERG STATED.
IF WE COULD BRING UP THE SLIDES.
THIS IS A DIAGRAM YOU'VE SEEN,
INVASION FUNNEL DESIGN, THE
HEART OF THE RADx PROGRAM.
WE HAVE TECHNOLOGY DEVELOPERS
RECEIVING STAGE GATED OR
MILESTONE-BASED PAYMENTS AS
INCENTIVES TO DE-RISK DEVICES,
SEAMS WILL TECHNOLOGY
DEVELOPMENT PIPELINE.
CRUCIAL TO THIS PROGRAM IS
PROVISION OF SUPPORT FROM TEAMS
FROM EXPERT CONSULTANTS IN
PARALLEL TO HELP ADDRESS
SCIENTIFIC, REGULATORY,
COMMERCIALIZATION NEEDS OF EACH
DEVELOPER.
ANOTHER CRITICAL COMPONENT THAT
WE HEARD ABOUT ON THE LAST PANEL
PRESENTATION IS INDEPENDENT
TESTING THAT ENSURES IT IS
WARRANTED.
NIBIB AND SIBLING CENTERS DID
NOT AND COULD NOT HAVE
ACCOMPLISHED THIS ALONE.
CENTRAL TO THE PAST, PRESENT,
AND FUTURE SUCCESS OF THIS
ENGINE OF DIAGNOSTIC AND MEDICAL
TECHNOLOGY INNOVATION ARE
PARTNERSHIPS.
THIS COLLABORATION ACROSS
GOVERNMENT, UNIVERSITIES,
INDUSTRY, NON-PROFIT
ORGANIZATIONS AMONG OTHERS IS
CRITICAL AS WE CONTINUE TO
ADAPT, EVOLVE, SCALE THE RADx
TECH PROGRAM AND ADDRESS HEALTH
TECHNOLOGY NEEDS FAR BEYOND
COVID-19.
AND THAT BRINGS US TO THE
OBJECTIVES OF THIS PANEL.
IT IS ONE THING TO WAX POETIC
ABOUT THE VALUE OF
COLLABORATION, NOT GOING ALONE
TO SAY IT TAKES A VILLAGE AND
SUCH BUT ANOTHER TO PROVIDE
CONCRETE EXAMPLES OF HOW THE
TALK OF COLLABORATION AND
WALKING THE WALK.
MY ESTEEMED PANELISTS WILL
HIGHLIGHT WAYS WE LEVERAGING THE
POWER OF PARTNERSHIPS, TO DRIVE
THE DEVELOPMENT OF DIAGNOSTICS,
WEARABLES, REMOTE MONITORING
TECHNOLOGIES, INTEGRATED
SENSORS, DIGITAL HEALTH
TECHNOLOGIES.
BUT THESE PROGRAMS NOT ONLY
SHOWCASE COLLABORATIVE
ENDEAVORS, THEY DEMONSTRATE HOW
WE'RE ADDRESSING SOME OF THE HOT
TOPICS IN PUBLIC HEALTH.
THESE ARE THE AREAS WHERE
SIGNIFICANT GAPS HAVE BEEN
IDENTIFIED.
AND TECHNOLOGICAL INNOVATION IS
SORELY NEEDED INCLUDING FETAL
HEALTH, POSTPARTUM HEALTH, HIV
AND TESTS FOR PERSONS WITH
DISABILITIES.
NOW THAT WE HAVE THIS STAGE SET
FOR THIS PANEL LET'S HAVE OUR
PANELISTS INTRODUCE THEMSELVES
STARTING WITH ANTONELLO, I'M A
PROGRAM OFFICER WITH THE
NATIONAL INSTITUTE OF CHILD
HEALTH AND HUMAN DEVELOPMENT,
INCLUDING MEDICAL DEVICES AND
RADx TECH HEALTH WHICH I
CO-LED WITH TAYLOR AND KARI
ASHTON.
>> GOOD AFTERNOON, I'M SALLY
MCFAUL, AND I'M ONE OF THE THREE
CO-P.I.s FOR ONE OF THE POINT
OF CARE TECHNOLOGY RESEARCH
NETWORK CENTERS.
OUR FOCUS IS ON HIV AND
COMORBIDITIES, DEVELOPING
TECHNOLOGY FOR LOW AND LOW- AND
MIDDLE-INCOME COUNTRIES,
SUB-SAHARAN AFRICA.
>> I'M BRIAN WALSH, FOR RADx I
WAS THE DEPLOYMENT CORE LEAD,
LED THAT GROUP ASSISTANT COMPANY
SCALE AND MANUFACTURE PRODUCT, A
YEAR AND A HALF AGO BECAME
PROGRAM ACCESSIBILITY MANAGER AS
WELL.
GREAT TO BE HERE.
>> GREAT.
THANK YOU SO.
YOU'LL HEAR MORE FROM EACH IN A
FEW MINUTES.
SO I'M GOING TO KICK OFF OUR
SERIES OF PRESENTATIONS BY
TELLING YOU ABOUT A RATHER YOUNG
PROGRAM, NO PUN INTENDED, RADx
TECH FETAL MONITORING CHALLENGE,
BIRTHED, PUN INTENDED THIS PAST
SEPTEMBER.
MOTIVATED BY THE FACT THAT FETAL
MORBIDITY AND MORTALITY ARE
MAJOR BUT OVERLOOKED PUBLIC
HEALTH ISSUES.
MUCH OF THE PUBLIC CONCERN
SURROUNDING REPRODUCTIVE LOSS
HAS LARGELY FOCUSED ON INFANT
MORTALITY, DUE TO A PAUCITY OF
KNOWLEDGE IN PART, OF THE
INCIDENCE, ETIOLOGY, PREVENTION
STRATEGIES FOR FETAL MORTALITY.
GLOBALLY THERE BE TWO MILLION
STILL BIRTHS EVERY YEAR, 40%
AFTER THE ONSET OF LABOR,
MAJORITY OF WHICH COULD BE
PREVENTED WITH BETTER QUALITY
AND RESPECTFUL CARE DURING
BIRTH.
IN THE UNITED STATES 21,000
FAMILIES A YEAR EXPERIENCE A
STILLBIRTH, A TRAGIC LOSS.
ADDITIONALLY FETAL MORTALITY
RATES IN THIS COUNTRY CONTINUE
TO VARY BY RACE AND ETHNIC
ORIGIN, BEING HIGHEST RATES FOR
NATIVE HAWAIIAN OR PACIFIC
ISLANDER AND BLACK WOMEN AND
AMERICAN INDIAN AND ALASKA
NATIVE WOMAN.
RACIAL DISPARITIES AND HEALTH
OUTCOMES ARE PERSISTENT AND WELL
DOCUMENTED.
FACTORS CONTRIBUTING INCLUDE
DIFFERENCES IN MATERNAL
PRE-CONCEPTION HEALTH, ACCESS TO
QUALITY HEALTH CARE.
SO, WHAT THIS DEMONSTRATES IS AN
UNACCEPTABLE STATE, FETAL HEALTH
OUTCOMES WITHIN THIS COUNTRY AND
AROUND THE WORLD.
THIS CALLS FOR IMMEDIATE ACTION.
ONE IS IMPROVEMENT OF THE
DIAGNOSIS AND MONITORING OF
PHYSIOLOGICAL CAUSES AND FACTORS
ASSOCIATED WITH FETAL MORBIDITY
AND MORE AT THAT TIMED NEEDED IN
AREAS WITH LIMITED ACCESS TO
QUALITY PRENATAL HEALTH CARE.
IN A SERENDIPITOUS MOMENT, A
THEME IS PARTNERSHIPS, NIBIB WAS
HAVING CONVERSATIONS REGARDING
DIAGNOSTIC DEVELOPMENT IN THE
MATERNAL FETAL SPACE, WITH TWO
PARTNERS AT THAT TIME, ONE WAS
MY COLLEAGUE ANTONNELLO, AND HIS
COLLEAGUES, THE OTHER WITH A
LONGTIME PARTNER, THE BILL AND
MELINDA GATES FOUNDATION.
WE'RE HAVING THESE DISCUSSIONS
CONCURRENTLY AND WE CAME
TOGETHER AND DECIDED WE WERE
GOING TO DO SOMETHING IN THIS
SPACE.
EACH PARTNER AND THIS
PARTNERSHIP BRINGS THEIR UNIQUE
STRENGTHS AND ABILITIES.
MEDICAL TECHNOLOGY DEVELOPMENT
IS A FOCUS OF NIBIB, MATERNAL,
FETAL, NEONATAL AND CHILD HEALTH
IS EMPHASIS IN STRENGTH, THE
GATES FOUNDATION BRINGS
EXPERTISE FOR GLOBAL HEALTH
SETS.
THE RADx CHALLENGE WAS BORN.
THROUGH THIS PARTNERSHIP BETWEEN
GOVERNMENT AND A NON-PROFIT
ORGANIZATION, WE'RE AIMING TO
SPEED INNOVATION AND POINT OF
CARE AND HOME-BASED DIAGNOSTIC
TECHNOLOGIES, THAT CAN HELP
IMPROVE FETAL AND NEONATAL
OUTCOMES THROUGH DETECTION AND
MONITORING OF FETAL HEALTH
STATUS AND ENABLE MORE
APPROPRIATE AND ACTIONABLE
CLINICAL INTERVENTION.
OF COURSE, SINCE THIS IS A FOCUS
ON RADx TECH WE'RE LEVERAGING
THE RADx TECH INNOVATION
FUNNEL PROGRAM DESIGN, AND
MERGING WITH THE PRIZE
COMPETITION MODEL WHICH YOU'LL
HEAR MORE IN THE NEXT
PRESENTATION WITH THE RADx
TECH MATERNAL HEALTH CHALLENGE.
WE'RE OFFERING CASH INCENTIVES
TO INNOVATORS AS THEY DE-RISK
AND VALIDATE TECHNOLOGIES,
SERIES OF STAGE-GATED AND
MILESTONE-BASED PRIZE AWARDS, A
TOTAL OF $2 MILLION IN CASH
PRIZEs IN THIS CHALLENGE WITH
THREE AWARD DISBURSEMENT POINTS
AND A SELECT GROUP OF INNOVATORS
INVITED TO NATCHER AT AT THE
END OF JANUARY DELIVERING LIVE
TECH DEMOS AND PITCH
PRESENTATION TO DECIDE WHO WILL
BE INVITED TO THE FINAL SPRINT
PHASE THAT WILL OH OTHER TRUE
THE SUMMER AND INTO THE FALL.
I WISH I COULD SAY MORE AND TELL
YOU ABOUT THE TECHNOLOGIES WE
HAVE IN OUR PORTFOLIO BUT THE
SUBMISSION DEADLINE WAS JUST TEN
DAYS AGO, SO THIS REALLY IS A
YOUNG PROGRAM.
AND I HOPE YOU ALL STAY TUNED
AND CONTINUE TO FOLLOW ALONG AS
WE ANNOUNCE IN THE WINTER WHAT
TECHNOLOGIES WILL BE ADVANCING
TO OUR TECH SPRINT PHASE.
I'M GOING TO CLOSE THERE AND
HAND THINGS OVER TO DR. PILEGGI.
>> THANK YOU, TAYLOR, FOR THE
NICE INTRODUCTION AND
OPPORTUNITY TO SHARE AN UPDATE
ON MATERNAL HEALTH CHALLENGE.
OKAY.
I'M A MEMBER OF THE EUNICE
KENNEDY SHRIVER NATIONAL
INSTITUTE WHICH MISSION IS
HEALTHY PREGNANCIES, HEALTHY
CHILDREN, HEALTHY AND OPTIMAL
LIVES.
AS PART OF THIS MISSION WE'RE
TRYING TO CONTRIBUTE TO THE
ADVANCEMENTS IN THE MED TECH
SPACE.
I WANT TO TAKE AN OPPORTUNITY TO
TALK -- MENTION JUST BRIEFLY
THIS PARTNERSHIP, PUBLIC/PRIVATE
PARTNERSHIP WE RECENTLY LAUNCHED
TOGETHER WITH THE FDA AND BARDA
DRIVE AND FOUNDATION OF THE NIH
TO REALLY BRING TOGETHER THE
PEDIATRIC MEDICAL DEVICE
ECOSYSTEM, A VERY EARLY STAGE,
WE LAUNCHED THIS SEPTEMBER, THE
OBJECTIVE IS TO DE-RISK AND MOVE
TECHNOLOGIES FOR CHILDREN
INCLUDING POINT OF CARE
TECHNOLOGIES, CENTRALIZED HEALTH
CARE SO WE ARE HOPING THROUGH
THE EXPERTISE LEVERAGED FROM THE
NIBIB WHICH IS CO-PARTNER IN
THIS ENDEAVOR WITH NICHD AND THE
NIH PEDIATRIC RESEARCH
CONSORTIUM WHERE WE CAN REALLY
MAKE IMPORTANT CHANGES IN THE
LANDSCAPE.
MATERNAL HEALTH, I WANT TO
STRESS WE'RE FACING A MATERNAL
HEALTH CRISIS IN THIS NATION.
AND THIS IS REALLY ADULTS WITH
THE TECHNOLOGIES AND THE LEVEL
OF HEALTH CARE THAT WE HAVE
AVAILABLE.
AND MATERNAL HEALTH REFERS TO
THE CONTINUUM FROM
PRE-CONCEPTION TO PREGNANCY AND
POSTPARTUM PERIOD.
THERE ARE A LOT OF POTENTIAL
INTERVENTIONS THAT CAN CHANGE
THE OUTCOMES.
I WILL GO BRIEFLY ON SOME STATS
THAT WILL REALLY MAGNIFY THE
LEVEL OF URGENCY FOR CHANGING
THE LANDSCAPE.
THIS IS A COMPARISON, IT'S
REALLY DATED, BUT THE CURRENT
STAGES IS NOT DIFFERENT, SHOWING
THE MATERNAL MORTALITY RATIOS IN
SELECTED COUNTRIES, ALL WESTERN
COUNTRIES.
YOU CAN RECOGNIZE FROM THE FLAGS
AND SEE THAT THE UNITED STATES
IS DOUBLE OF THE HIGHEST IN
TERMS OF MORTALITY RATIOS
OVERALL, WHICH IS CONCERNING.
THE TREND HAS BEEN FAIRLY
OPPOSITE TO WHERE OTHER
COUNTRIES ARE GOING, THE UNITED
STATES IS CONTINUING TO GO UP,
OTHER NATIONS ARE PUTTING IT
DOWN.
AND ALSO IN TERMS OF THE WINDOW
OF WHEN THE MOST OF THE
FATALITIES AND MORBIDITY AND
MORTALITY IS GENERALLY IN THE
PERI DELIVERY PERIOD, CLOSE TO
DELIVERY, WITHIN THE FIRST YEAR,
POSTPARTUM PERIOD, ALMOST HALF
OF THE MORTALITY REALLY IS
DURING THIS WINDOW OF TIME.
AND THERE ARE A NUMBER OF
CONDITIONS THAT CONTRIBUTE TO
THIS MORTALITY, MOSTLY
HEMORRHAGE, GENERALLY EARLY
AFTER DELIVERY, BUT ALSO
CARDIOVASCULAR INFECTIONS AND
THAT ARE CONTRIBUTING TO THIS.
OVER 60% IT'S ESTIMATED OF
PREGNANCY-RELATED DEATHS ARE
PREVENTIBLE, AND THERE ARE A
NUMBER OF VARIABLES AND
IMPLEMENTABLE INTERVENTIONS THAT
COULD REALLY CHANGE THE COURSE
OVER THERE.
WHO ARE THE MOST AFFECTED
POPULATIONS?
GENERALLY THE YOUNGEST AND
OLDEST PREGNANCY INDIVIDUALS.
THERE IS ALSO AN ISSUE OF HEALTH
DISPARITIES RELATED TO RACE AND
HISPANIC ORIGINALS, BUT MOSTLY
AMERICANS ARE THE ONES WHO HAVE
THE WORST OUTCOMES.
THERE IS ALSO AN IMPACT OF WHERE
YOU LIVE AND ACCESS TO HEALTH
CARE.
AND THIS BRINGS US TO THE BIG
ISSUE OF MATERNAL HEALTH CARE
DESERTS, WHICH ARE AREAS WHERE
MOSTLY RURAL BUT NOT ONLY RURAL,
THERE ARE ALSO URBAN AREAS WHERE
THERE ARE NO MATERNAL HEALTH
CARE CENTERS WHERE INDIVIDUALS
WHO ARE PREGNANT, WHO HAVE GIVEN
BIRTH CAN HAVE SPECIALIZED
ACCESS TO HEALTH CARE.
AND THIS IS REALLY ASSESSED TO
BE GETTING WORSE BECAUSE MORE
AND MORE CENTERS HAVE BEEN
CLOSED IN THOSE AREAS, THE MAP
IS QUITE CONCERNING.
SO, THE NIH HAS INTRODUCED
SEVERAL YEARS AGO THE
IMPLEMENTING A MATERNAL HEALTH
AND PREGNANCY OUTCOME VISION FOR
EVERYONE IMPROVED INITIATIVE
WHICH IS REALLY TARGETED TO
SPECIAL EMPHASIS ON HEALTH
DISPARITIES IN POPULATIONS
DISPROPORTIONATELY AFFECTED SUCH
AFRICAN AMERICAN BLACK WOMEN,
AMERICAN INDIANS, ALASKA NATIVE,
ASIAN/PACIFIC ISLANDERS, VERY
YOUNG WOMEN AND OF ADVANCED
MATERNAL AGE AND WITH
DISABILITIES.
THIS IS A TRANS-NIH INITIATIVE
THAT TOUCHES MANY INSTITUTES AND
CENTERS OF THE NIH.
AND RECENT ACTIVITIES OF THIS
ADMINISTRATION, THE WHITE HOUSE
HAS INTRODUCED INCLUDE THE WHITE
HOUSE BLUEPRINT FOR ADDRESSING
MATERNAL HEALTH CRISIS, THERE
WAS RELEASED IN JUNE 2022, AND
VERY RECENTLY FROM NOVEMBER 13
WHITE HOUSE INITIATIVE ON
WOMEN'S HEALTH RESEARCH, IT'S
TIME TO REALLY ADDRESS THIS
CRISIS.
A STATEMENT HAS BEEN PUBLISHED
IN OCTOBER IN JAMA VIEWPOINTS,
BRINGS A NICE OVERVIEW OF WHERE
THE NIH IS CONCENTRATING.
AS PART OF THE INITIATIVE, THERE
HAVE BEEN A NUMBER OF
ACTIVITIES, THE MOST MERITORIOUS
IS CENTERS OF EXCELLENCE
RECENTLY RELEASED, SCATTERED
THROUGHOUT THE NATION TO TRY AND
ADDRESS THIS IMPORTANT CRISIS.
AT THE END OF 2022 WE WERE GIVEN
THE OPPORTUNITY TO PUT TOGETHER
THE CHALLENGE FOR MATERNAL
HEALTH -- TRYING TO PRETTY MUCH
TAKE THE PLATFORM RADx TECH
FOR THE RESPONSE TO THE COVID,
AND PUT IT, HIJACK IT TO ADDRESS
ANOTHER CRISIS.
I MUST SAY IT WAS A GREAT
EXPERIENCE, WE JOINED FORCES
WITH NIBIB AND THE
INFRASTRUCTURE OF POCTRN IS
REALLY THE UNDERLYING MOTOR AND
WE WERE ABLE TO PUT TOGETHER
THIS CHALLENGE.
THE PROBLEM THAT WE'RE TRYING TO
ADDRESS IS IN THE POSTPARTUM
PHASE, WITHIN THE FIRST YEAR
AFTER DELIVERY, AND IN TRYING TO
REALLY BRIDGE THE HEALTH CARE
THROUGH TECHNOLOGIES THAT CAN
REALLY REDUCE BURDEN ON
INDIVIDUALS LIVING IN THOSE
AREAS.
AND THIS BASICALLY WAS OPEN TO
TECHNOLOGY THAT HAD TO BE FAIRLY
MATURE TO THE POINT THAT THEY
WOULD BE IN THE COMMERCIAL PHASE
WITHIN THREE TO FIVE YEARS.
AND THIS IS A MODIFIED VERSION
OF THE INNOVATION PANEL.
WE HAD UP TO 8 MILLION ALLOTTED
TO PRIZES, WITH STEPWISE
APPROACH, AT EACH STEP THERE
WILL BE ASSESSMENT AND A NUMBER
OF -- REDUCING NUMBER OF
SOLUTIONS WILL MOVE TO THE NEXT
PHASE.
RIGHT NOW WE'RE IN THE LAST
PHASES OF OF THE TECHNOLOGY
ASSESSMENT AND WE'RE EXPECTING
THE FINALISTS TO BE DECIDED AT
THE BEGINNING OF NEXT YEAR BY
MARCH SOMEHOW
>> I WILL SKIP THIS FOR THE SAKE
OF TIME.
THERE WERE SPECIFIC EVALUATION
CRITERIA, IN THE TARGETED
POPULATIONS IN MATERNAL HEALTH
CARE DESERTS AND
UNDERREPRESENTED.
REGULATORY ASPECT AND
COMMERCIALIZATION IN THE TIME
FRAME THAT I ALLUDED TO.
THOSE ARE THE TEN STILL IN THE
COMPETITION.
DR. TROMBERG GAVE A VIEW THIS
MORNING, WE COVERED A LITTLE BIT
OF EVERYTHING, SOME FOCUS ON
INFECTION, SOME FOCUS ON
CARDIOVASCULAR RISK.
HEMORRHAGE, AND MENTAL HEALTH,
SO THERE'S QUITE A WIDE VARIETY
OF PORTFOLIO IN THIS -- OF
TECHNOLOGIES WE WERE ABLE TO
ACCESS.
IT'S BEEN A FAIRLY COMPRESSED
SCHEDULE.
I MUST SAY OUR COLLEAGUES
WORKING ON THIS WERE FAIRLY
SURPRISED THIS WAS MORE RELAXING
IN TERMS OF SCHEDULE AND DEMAND
THAN FOR COVID.
SO THERE'S AN URGENCY TO MOVE
THOSE TECHNOLOGIES AND FOSTER
THEM INTO IMPLEMENTATION AND WE
WERE COGNIZANT THAT, YOU KNOW,
THERE IS THE NEED FOR MORE
INVESTMENT IN THIS SPACE AND WE
WANT TO MAKE SURE THOSE
TECHNOLOGIES THAT WOULD MAKE IT
THROUGH THE PROGRAM WILL BE ABLE
TO GET TO THE PATIENTS IN NEED
WITHIN THE TIME FRAME WE GAVE
OURSELVES.
SO THERE ARE NUMBER OF THOSE
MOST LIKELY WILL BE ABLE TO GET
INTO THE CENTER OF EXCELLENCE
FOR IMPLEMENTATION PHASE, BUT WE
WELCOME ADDITIONAL TECHNOLOGIES
THAT COME INTO THE PIPELINE
THROUGH THE NIH TO HELP ADDRESS
THIS IMPORTANT CRISIS.
AND THIS IS JUST A SUMMARY OF --
ONLY SOME OF THE BIG TEAM THAT
IS WORKING ON THIS.
AND I'LL STOP THERE.
THANK YOU VERY MUCH FOR YOUR
ATTENTION.
[APPLAUSE]
>> I'M HERE TO TALK ABOUT A
FUNDING OPPORTUNITY THAT WAS
INITIATED LAST YEAR AROUND THIS
TIME TO DEVELOP PLATFORMS FOR
HIV VIRAL LOAD TESTING AT THE
POINT OF CARE.
I'M ONE OF THE CO-P.I.s FOR
THE CENTER FOR INNOVATION AND
POINT OF CARE FOR HIV/AIDS AND
EMERGING INFECTIOUS DISEASES.
I'M ALSO THE DIRECTOR OF THE
TECHNOLOGY CORE.
OUR CENTER IS FUNDED BY NIBIB,
FOGARTY INTERNATIONAL CENTER AND
OFFICE OF AIDS RESEARCH.
OUR FOCUS IS ON HIV AND
CO-MORBIDITIES AND TECHNOLOGIES
THAT WILL IMPROVE PEOPLE WHO
LIVE WITH HIV.
SO, I HAVE A CONFLICT OF
INTEREST, I WAS A FOUNDER AND
FORMER CSO OF MINUTE MOLECULAR
DIAGNOSIS, WE RECEIVED FUNDING
FROM RADx TO DEVELOP A
POINT-OF-CARE PLATFORM CALLED
DASH, WHICH MANY PEOPLE IN THIS
ROOM HELPED ME TO GET TO THE EUA
FINISH LINE SO THANK YOU.
MINUTE MOLECULAR MERGED ARE
NUCLEIN AND I'M A SHAREHOLDER.
I DO WANT TO TELL YOU THAT HIV
DISEASE IS NOT A THING OF THE
PAST.
IT REMAINS A PROBLEM IN THE U.S.
AND GLOBALLY.
CURRENT U.S. EPIDEMIOLOGY FROM
2021 IS 1.2 MILLION PEOPLE WITH
HIV LIVING IN THE U.S.
MORE THAN HALF OF THEM ARE OVER
50 YEARS OLD.
BUT 1 IN 8 ARE UNAWARE OF HIV
SEROSTATUS.
AND OF THOSE PEOPLE WHO ARE
UNAWARE OF THEIR STATUS, 40%
GENERATE NEW INFECTIONS.
SO IN 2021, OVER 36,000 NEW
INFECTIONS WERE IN THE U.S., AND
THIS WILL BREAK DOWN THE NEW
INFECTIONS, BUT WHAT I THINK IS
REALLY IMPORTANT, I'M GOING TO
SHOW YOU THIS SLIDE FIRST, IS
IT'S NOT NECESSARILY AN URBAN
ONLY PROBLEM.
A LOT OF REGIONS IN THE SOUTH
HAVE FEWER URBAN AREAS THAT NEED
HIV SERVICES, AND SO THIS IS A
REALLY STRONG REASON TO PROMOTE
POINT OF CARE TECHNOLOGY AND
HOME-BASED TECHNOLOGY.
SO THAT WE CAN REALLY TRY TO
REACH PEOPLE WHO MAY NOT
RECEIVE -- HAVE ACCESS TO THAT
CARE.
UNAID HAS A GOAL OF ENDING THE
HIV EPIDEMIC AS A PUBLIC HEALTH
CRISIS IN 2030.
AND SO THEY HAVE SET GOALS FOR
PEOPLE WHO KNOW THEIR STATUS, IF
THEY ARE ON HIV THERAPY, AND IF
THEIR VIRAL LOAD IS SUPPRESSED.
IT'S 95-95-95.
STATISTICS ON THIS SLIDE
INDICATE WHERE WE WERE IN 2021
IN THE U.S., STATISTIC CAME FROM
THE CDC.
WE STILL HAVE A LARGE NUMBER OF
NEW INFECTIONS, AND BY 2025 WE'D
LIKE TO REDUCE THAT BY 75%, AND
BY 90% BY 2030.
87% OF PEOPLE DIAGNOSED ARE
ACCESSING TREATMENT, 66% VIRALLY
SUPPRESSED.
TAKING PROPHYLACTIC TREATMENT
CALLED PREP, 30% OF ELIGIBLE
PEOPLE TAKE THE MEDICATION.
BY 2025, THE GOAL IS TO INCREASE
THAT TO 50%.
SO, VIRAL LOAD AND PREP USE
REQUIRE REGULAR DIAGNOSTICS, SO
THAT ALSO IS A VERY STRONG CALL
FOR POINT-OF-CARE DIAGNOSTICS
FOR HIV.
SO, THANK YOU FOR THIS SLIDE.
USE CASES FOR HIV, RNA DETECTION
PLATFORMS, SO WE CAN USE THEM
FOR ACUTE HIV INFECTION BEFORE
PEOPLE HAVE ANTIBODIES IN THEIR
BLOOD, FOR MONITORING VIRAL
LOADS, MONITORING PREP, EARLY
INFANT DIAGNOSTICS.
SO THERE ARE A NUMBER OF
DIFFERENT USE CASES FOR THESE
TESTS.
AS I MENTIONED, CFAN IS FUNDED
BY OFFICE OF AIDS RESEARCH, LAST
YEAR SELECTED TO DEVELOP A
PROJECT WITH POCTRN AND RADx
TO ACCELERATE DEVELOPMENT OF HIV
VIRAL LOAD PLATFORMS.
THE COORDINATING CENTER
ORGANIZED A PROGRAM INITIATION,
WROTE THE SOLICITATION, RECEIVED
APPLICATION, REVIEWED THEM, THEY
WERE SELECTED AND WE CONTRACTED
AND WE'VE HAD ONE PROGRESS
REVIEW AND WE'RE ON OUR SECOND.
SO EACH PROJECT IS BETWEEN ABOUT
9 TO 12 MONTHS.
SO, SOLICITATION WAS PUBLISHED
LAST YEAR ON NOVEMBER 3, CLOSED
ON DECEMBER 1.
WE RECEIVED 16 APPLICATIONS
REVIEWED BY THE RADx NIH AND
POCTRN COMMITTEE.
IT WAS BENEFICIAL THAT WE HAD
ALL WORKED TOGETHER THROUGH
RADx FOR THIS REVIEW BECAUSE I
THINK WE LEARNED A LOT FROM EACH
OTHER'S VIEWPOINTS, AND PICKED
SIX PROJECTS FOR RECOMMENDED FOR
FUNDING.
ONE OF THE GROUPS DECLINED THE
FUNDING, AND SO WE WENT AHEAD
WITH FIVE PROJECTS INITIATED AND
WORKING TOWARDS MILESTONES.
SO, THIS PROJECT IS ORGANIZED
WHERE THERE'S A PRODUCT -- A
POCTRN AND RADx TEAM FOR EACH
ONE OF THE FIVE PROJECTS.
SO, THERE'S EACH OF THE PROJECTS
HAS A POCTRN MEMBER AND A RADx
TEAM MEMBER, PLUS A RADx
PROJECT FACILITATOR AND WE MEET
ON A REGULAR BASIS AND DISCUSS
OUR MILESTONES, AND ANY PROBLEMS
THAT THEY ARE EXPERIENCING, AND
I HOPE THAT MY GROUP THAT I WORK
WITH AGREES I THINK IT REALLY IS
BENEFICIAL TO HAVE SOMEONE WHO
HAS DEEP HIV EXPERIENCE AND
COUPLE WITH SOMEONE WHO HAS MORE
DIAGNOSTIC TECHNOLOGY
DEVELOPMENT AND MANUFACTURING
EXPERIENCE SO I THINK TO GET A
NICE WELL-ROUNDED MAYBE MORE
ADVICE FROM ME THAN THEY WANT
BUT IT'S WORKING REALLY WELL.
IN ADDITION TO OUR REGULAR
MEETINGS AND OUR SUPPORT THROUGH
THEIR MILESTONE, THEY HAVE ALSO
HAD FOUR DIFFERENT WEBINARS FOR
THESE TEAMS, ON A REALLY
IMPORTANT TOPIC, HIV TESTING AND
MARKET LANDSCAPE, REGULATORY
PATHWAYS AND LANDSCAPE, TWO
PROJECTS ON REIMBURSEMENT, WHICH
GIVES THE TEAMS SOME CONTEXT FOR
HOW TO DEVELOP AND HIV VIRAL
LOAD TEST.
ALL THE PROJECTS ARE AT AN EARLY
STAGE FOR VERY GOOD REASON
BECAUSE THE FDA JUST MOVED HIV
VIRAL LOAD INTO THE 510(K)
CATEGORY, ACCESSIBLE FOR SMALL
COMPANIES TO DEVELOP A TEST AND
TO MARKET.
THE OFFICE OF AIDS RESEARCH HELD
A WORKSHOP FOR TWO DAYS ON KIND
OF COMMUNITY VOICES AROUND
TECHNOLOGY, TO FIND OUT WHAT THE
COMMUNITY WANTS, WHAT ARE PAIN
POINTS, WHAT IS HELPFUL IN
WORKING FOR SELF-TESTING AND
PERSONALIZED VIRAL LOAD AND THEN
THE TECHNOLOGY DEVELOPERS LIKE
MYSELF TALKED ABOUT WHAT IS
POSSIBLE, AND I THINK THIS
REALLY -- I PUT THE YouTube
LINKS SO YOU CAN WATCH IF YOU'D
LIKE, BUT I THINK IT SHOWS A
CONTINUED INTEREST TO DEVELOP
HOME-BASE AND POINT-OF-CARE
TESTS FOR HIV.
OUR HOPE IS THIS EARLY PILOT
PROJECT WHICH IS BRINGING THESE
COMPANIES ALONG SO THEY HAVE
KIND OF DE-RISKED ACCELERATED
DEVELOPMENT SO THAT A LARGER
RADx-TYPE FUNNEL COULD BE HELD
AND IF IT IS TO HAPPEN, WHAT WE
BELIEVE NEEDS TO HAPPEN IS
DEFINE PLATFORM CAPABILITIES AND
REALLY DO A DETAILED LANDSCAPE,
AND ALSO TO FIND THAT USER NEEDS
AND OAR IS ALREADY WORKING ON
THAT WITH THEIR COMMUNITY
WORKSHOP.
OF COURSE, TO FUND SOME
PROMISING INNOVATIONS AND THEN
VALIDATE, VERIFY, OPTIMIZE,
ACCELERATE.
THAT SOUNDS LIKE WHAT POCTRN IS
GOOD AT.
WE'RE INSPIRED BY THIS.
WHAT WE'VE DECIDED TO DO IN OUR
SOLICITATION PUBLISHED NEXT YEAR
WE THINK SAMPLE VOLUME IS A
BARRIER, PLASMA CELL VOLUME, SO
WE'RE GOING TO ASK FOR
TECHNOLOGY DEVELOPMENT IN THAT
AREA.
AND WE WOULD LIKE TO KNOW USE OF
PREFERENCES, SO WE HAVE A PLAN
FOR A PROJECT WE'RE GOING TO --
KARA AND OUR DISSEMINATION CORE
PLANS TO PLAN A STUDY TO LOOK AT
USER PREFERENCES WITH A
QUANTITATIVE STUDY.
SO, WE'RE TRYING TO PUSH THIS
ALONG BECAUSE WE THINK IT'S VERY
EXCITING, AND REALLY NECESSARY,
AND ALL THE ADVANCES THAT ARE
MADE FOR POINT OF CARE
TECHNOLOGY HERE, ESPECIALLY
HOME-BASED TECHNOLOGY, CAN BE
EASILY TRANSFERRED TO LOW- AND
MIDDLE-INCOME COUNTRIES, OUR
EXCITEMENT AND PASSION.
I WANT TO ACKNOWLEDGE THE PEOPLE
THAT PARTICIPATED IN THIS PILOT
PROJECT AND ALSO AWARDEES, I
WANT SURE IF THAT WAS PUBLIC SO
I DIDN'T DISCUSS YOUR WORK WITH
YOUR INFORMATION ON THERE, BUT
OF COURSE YOU ARE WHY WE'RE
DOING THIS.
THANK YOU.
>> OKAY.
SORRY ABOUT THAT.
SO, I'LL SPEND A FEW MOMENTS
TALKING ABOUT THE ACCESSIBILITY
PROGRAM, OUR RELATIONSHIP WITH
ADVOCACY GROUPS, SOMEWHAT UNIQUE
IN THE OVERALL PROGRAM, AND OUR
EXPERIENCES WERE SOMEWHAT
SPECIAL.
I THINK IT'S ONLY APPROPRIATE
GIVEN THAT THE ACCESSIBILITY
PROGRAM ACTUALLY CAME FROM THE
GROUPS, IN JANUARY 2022, LETTERS
WERE WRITTEN BY A COLLECTION OF
ADVOCACY GROUPS TO THE WHITE
HOUSE, ESSENTIALLY SAYING IT'S
GREAT, YOU'RE MANUFACTURING A
TON OF TEST, PROVIDING THEM TO
THE PUBLIC BUT THEY ARE NOT
ACCESSIBLE AND DON'T WORK FOR
US.
THE WHITE HOUSE IMMEDIATELY
RESPONDED WITH SOME FUNDING.
THAT WAS ABOUT $30 MILLION.
TO START A PROGRAM.
AND SO, BASED ON THAT WE STOOD
UP -- WELL, THE FIRST STEP WAS
ACCESSIBILITY LISTENING SESSION,
THE GOALS, UNDERSTAND THE
CHALLENGES TO THE ACCESSIBILITY
AT HOME TEST, DISCUSS POTENTIAL
IMPROVEMENT INCLUDING TIMELINE
AND OPEN LINES OF COMMUNICATION
FOR ONGOING DISCUSSION.
IT WAS WELL ATTENDED, MULTIPLE
BREAKOUT SESSIONS HERE,
IMPORTANTLY THE LEFT-HAND SIDE
FOR THE ADVOCACY GROUPS, MOST
STAYED WITH US IN OUR SUBSEQUENT
MEETINGS WHICH WE HAD MONTHLY,
TO KEEP THEM UPDATED.
ON THE RIGHT-HAND SIDE I THINK
SOME OF THE AGENCIES
SELF-SELECTED AS TO WHERE THEIR
INTEREST WAS BUT IT WAS A
WELL-ATTENDED AND VERY POPULAR
EVENT.
SO, BASED ON THAT FUNDING, THEN
SUBSEQUENT FUNDING WHICH CAME
OUT A BIT LATER, ABOUT SIX
MONTHS LATER, PRETTY
SIGNIFICANT, TWO PROGRAMS WERE
STOOD UP.
ONE IS MINI ACCESSIBILITY
PROGRAM, THIS WAS DESIGNED TO
REDESIGN EXISTING OVER THE
COUNTER TESTS DRAWN OUT OF THE
RADx TECH OTC POOL, ABOUT 24
OF THOSE IN THAT POOL.
AND WE SAID IF YOU'RE IN THIS
POOL, YOU'RE IN THE PROGRAM
UNLESS YOU DON'T WANT TO BE.
THE SECOND GROUP WAS A
SOLICITATION FOR NEW TESTS, SO
INSTEAD OF REDESIGNING EXISTING
TEST WE WOULD TAKE AND SAY
LET'S DESIGN FROM SCRATCH.
ONE COMPONENT WAS FOCUSED ON
ACCESSIBILITY WITH COMPARABLE
TEST PERFORMANCE AS EXISTING
TESTS ALREADY ON THE MARKET, AND
THE SECOND WAS HIGH PERFORMANCE
TEST WHICH WAS -- PERFORMANCE
HAD TO EXCEED PERFORMANCE OF
TESTS ON THE MARKET.
SO, WHAT OUR FIRST STEPS WERE
ONCE WE STOOD UP THE PROGRAM WE
STARTED WITH INTERNAL
ACCESSIBILITY ASSESSMENTS
LOOKING AT HOW COMPLEX ARE THESE
THINGS, HOW MANY STEPS, HOW MANY
COMPONENTS, HOW SMALL, THINGS
LIKE THAT.
WE CONTRACTED WITH EXPERIENCED
ACCESSIBILITY DESIGN FIRMS, VERY
COMMERCIAL TYPE APPROACH.
AND WE STARTED TO KIND OF GET
INTO IT, AND WE STARTED TO LOOK
AT HOW THEY SIMULATED THEIR WORK
ENVIRONMENTS, SO SOME OF THIS
WAS WE DARKEN A ROOM TO SIMULATE
BLINDNESS, SOME WAS WEAR MITTENS
AND GLOVES TO SIMULATE POOR
DEXTERITY, THIS DOESN'T
REPRESENT THE POPULATION.
WHEN WE FIRST STARTED TO WORK
WITH ADVOCACY GROUPS THEY
ENCOURAGED US TO INCLUDE TARGET
POPULATIONS, STRONGLY IS SOFT
FOR HOW THEY PUT IT.
THEY WANTED US TO INVOLVE THEM
DIRECTLY WITH THE TARGET
POPULATIONS.
OUR TARGET POPULATIONS WERE LOW
VISION, NO VISION, POOR
DEXTERITY, AGING POPULATIONS.
SO, BASED ON THAT WE CREATED A
POOL OF SUBJECT MATTER EXPERTS
FROM TARGET POPULATIONS WITH
REPRESENTATIVES WHO HAD
CONDITIONS AS SUBJECT MATTER
EXPERTS.
WE SECURED ACADEMIC SUBJECT
MATTER EXPERTS FUNDED BY NIDILRR
AND TALKED TO A NUMBER OF
NIDILRR-FUNDED SITES.
IT ENDS UP MARYLAND WAS
ACTUALLY -- HAD SEVEN THAT WERE
QUITE GOOD, SECURITY THOSE,
INCORPORATED GEORGIA TECH HOME
LAB INTO OUR REVIEWS, A
USABILITY USING QUANTITATIVE,
USING KNOBS, MORE OF A TACTILE
APPROACH, AND WORKED WITH
ADVOCACY GROUP BECAUSE WE NEEDED
MORE RESOURCES AS THE PROGRAM
WENT ON.
THIS IS THE GENERAL FRAMEWORK WE
USED TO LOOK AT ACCESSIBILITY.
SO WHAT TYPICALLY -- THIS IS HOW
WE ASSESSED THEM.
YOU CAN IMAGINE MORE CRITERIA,
MOST SAY WE COLLECT AND DO
SOMETHING AND WE GET A RESULT.
THAT'S THE WORLD THEY LOOK AT.
WE WANTED TO LOOK FROM BEGINNING
TO END BECAUSE IF THERE'S A STEP
THAT APTS BE PERFORMED IT STOPS
THE REST OF THE STEPS.
YOU COULD HAVE THE MIDDLE BIT,
SUPER ACCESSIBLE, IF YOU CAN'T
OPEN THE BOX UNLESS YOU USE
SCISSORS OR A KNIFE AND GRANDMA
HAS A SAW OR WE'VE HAD TESTS TO
TEAR OPEN THE BOX, THINGS LIKE
THAT, YOU CAN'T BUY THE DEVICE
BECAUSE IT DOESN'T HAVE A
TACTILE QR CODE THAT LEADS TO A
PLACE TO DESCRIBES IF IT'S
EXPIRED AND WHAT THE TEST IS
ABOUT, THAT'S A PROBLEM.
YOU HAD TO LOOK AT THE FULL
SPECTRUM OF THE USE OF THESE
PRODUCTS.
THE OTHER THING THAT WE CAME TO
REALIZE AFTER TEN OF THESE THEY
START TO BECOME SIMILAR.
GRANTED TECHNOLOGIES COULD BE
DIFFERENT, WITH DIFFERENT WAYS
OF DOING THIS, YOU PUT THEM IN
GENERAL CATEGORIES, AND YOU
COULD SYSTEMATIZE AT SOME LEVEL.
THE OTHER THING, A LOT OF THE
SUPPLIES OUTSIDE OF COVID
IVDs, IVDs IN GENERAL, TESTS
IN GENERAL, POTENTIALLY MEDICAL
DEVICES IN GENERAL, YOU CAN LOOK
AT A BEACH HEAD AND ENTRY POINT
OF BIGGER WORLD.
THIS IS THE PROCESS WE'VE USED
IN THE MINI PROGRAM WHERE WE LET
HOME LAB RUN TESTS THROUGH THEIR
PROCESS, WITH SUBJECT MATTER
EXPERTS GO THROUGH A PROCESS AS
WELL AS GIVE US FEEDBACK.
WE MET WITH THE DESIGN FIRMS AND
SUBJECT MATTER EXPERTS.
THEY WORK TOGETHER.
WE MET WITH A COMPANY AND SAID
HERE IS WHAT WE FIND, HERE ARE
OPTIONS AND THINGS TO THINK
ABOUT DOING AND WENT THROUGH A
VALIDATION AND PROTOTYPING
PHASE.
WE BUILT 87 COMPONENTS THAT WE
TESTED AND TRIED TO VALIDATE FOR
USABILITY AND ACCESSIBILITY,
TRYING TO FIGURE OUT WHAT'S THE
BEST STOP OR BOTTLE, HOW DOES IT
NEED TO BE DESIGNED AND DO THIS
WELL.
ULTIMATELY LED TO
IMPLEMENTATION.
SO MINI PROGRAM STARTED WITH 24
TESTS IN THE BEGINNING.
WE FIRST MET WITH THOSE, AGAIN,
YOU WERE IN THE PROGRAM UNLESS
YOU OPTED TO BE OUT, THESE WERE
RADx OTC TESTS, WEREN'T
DESIGNED TO BE ACCESSIBLE, SOME
GOOD, SOME NOT SO MUCH.
FIFTEEN WENT FORWARD, NINE
DECLINED OR HAD TECHNICAL
CHALLENGES, CODE FOR THEY DIDN'T
SEEM TO WORK WELL SO WE DIDN'T
PURSUE THEM.
SOME DECLINED TO PARTICIPATE
BECAUSE IT DIDN'T MAKE SENSE.
WE HAD ONE TEST WITH 61 STEPS
THAT NO MATTER HOW MUCH MONEY
AND EFFORT AND TIME AND RESOURCE
WE PUT TOWARDS THAT, WE WEREN'T
GOING TO FIX 61 STEPS FOR
SOMEBODY DEALING WITH
ACCESSIBILITY CHALLENGES.
ULTIMATELY THOSE WENT THROUGH A
HOME LAB USABILITY ANALYSIS,
SUBJECT MATTER EXPERT REVIEW AND
THEN SOME DESIGN FROM CONCEPTS
AND ULTIMATELY 12 WENT TO PANEL
REVIEW, IT ENDS UP YOU SEE THEY
DECLINED TO PARTICIPATE OR IT
TECHNICAL CHALLENGES AT THAT
POINT BECAUSE SOME OF THE DESIGN
CHANGES WERE SIGNIFICANT.
IF IT COST $30 MILLION TO REDO A
PRODUCTION LINE, IT'S NOT A
GREAT THING, COMPANIES DECLINED
TO PARTICIPATE.
IF YOU CHANGED YOUR COST OF GOOD
BY FACTOR OF 2 1/2 OR 3, THEY
WOULD DECLINE TO PARTICIPATE.
SO WE'RE DOWN TO FIVE STILL IN
THE PROGRAM, THREE ACTIVELY
BUILDING PRODUCT AND REDESIGNING
PRODUCT RIGHT NOW FOR RELEASE TO
MARKET.
ONE OTHER ONE IS IN THE RADx
THREE WHICH I'LL TALK ABOUT, THE
OTHER ONE IS PENDING A DECISION,
ON THE RIGHT-HAND SIDE YOU CAN
SEE AN EXAMPLE OF A HOME LAB
USABILITY TASK ANALYSIS, THIS IS
ONE TABLE THAT WAS OUT OF THE
REPORT CATEGORIZING FOUR GROUPS
AS WELL AS INACCESSIBLE
ESSENTIAL AND NON-ESSENTIAL
TASKS, ESSENTIAL TASKS ARE TASKS
YOU HAVE TO BE ABLE TO DO TO
PERFORM THE TEST.
NON-ESSENTIAL TASKS ARE THROWING
IT WITH A, I STILL COULD PERFORM
THE TEST BUT AT THE END IT
DIDN'T MATTER TO THE TEST
ITSELF.
THIS IS THE TECH THREE FINAL.
215 APPLICANTS.
THEY ALL WENT THROUGH VIABILITY
REVIEW PANEL, DEEP DIVE
ASSESSMENTS, 64 OF THOSE.
STEERING PANEL REVIEWS, 29 IN
THE DE-RISKING PHASE, SO THAT'S
AS FAR AS WE'VE GOTTEN THROUGH
THE PROCESS SO FAR.
THERE'S STILL MORE REVIEWS,
IMPLEMENTATION PHASE TO FOLLOW.
THE BALANCE IS ABOUT 25% TOWARDS
THE ACCESSIBILITY PROGRAM, ABOUT
75% MORE TOWARDS THE HIGH
PERFORMANCE PORTFOLIO.
SO, I WANTED TO TALK ABOUT BEST
PRACTICES FOR A SECOND.
BECAUSE ONE OF THE THINGS WE
REALIZED IN GOING THROUGH THIS
PROCESS IS THAT WE SAW CERTAIN
THINGS WOULD HAPPEN AGAIN AND
AGAIN AND AGAIN.
WE REACHED THE POINT AFTER
MAKING THE 87 MODELS AND TESTING
THEM AND TRYING TO DECIDE WHICH
IS THE BEST THAT WE NEEDED TO
CAPTURE THIS INFORMATION.
SO, WE DECIDED WE WOULD BUILD A
BEST PRACTICES DOCUMENT.
THERE WEREN'T -- THERE AREN'T
GUIDELINES OR STANDARDS IN THE
SPACE SO WE WANTED TO BUILD
SOMETHING.
AND THERE WAS A LOT OF THINGS WE
LEARNED IN THIS PROCESS.
WE KNEW THAT IF THIS PROGRAM
ENDED, WE WOULD LOSE AULD OF
THAT.
WE WANTED TO CAPTURE THAT,
LEVERAGE LEARNING AND EXPERIENCE
FROM RADx TECH ACCESSIBILITY
FOR CURRENT AND FUTURE TESTS,
THE TARGET AUDIENCE HERE WAS THE
COMMERCIAL MANUFACTURERS AND
DESIGNERS, IT WAS NOT DIRECTLY
RELATED TO ADVOCACY GROUPS
BECAUSE WE WANTED TO FIND AN
EASY WAY TO HELP MANUFACTURERS
GET IT RIGHT.
SO AN EXAMPLE OF WHAT THE FORMAT
IS.
ON THE LEFT-HAND SIDE IT HAS AN
ISSUE OF TYPICAL IMPLEMENTATION.
ON THE RIGHT-HAND SIDE AN
IMPLEMENTATION.
THIS IS COMMON ON THE LEFT WHERE
THE TAMPER SEAL IS CLEAR, YOU
CAN'T SEE IT.
IT MAY BE HARD TO OPEN.
YOU MAY NEED A TOOL, IT MAY BE
SHARP, WHICH IS WORSE IN A
DISABLED COMMUNITY.
THE RIGHT-HAND SIDE RECOMMENDS
SOMETHING YOU CAN SEE THAT YOU
CAN REACH, PIAL AWAY.
THIS IS A SIMPLE EXAMPLE,
140-PAGE DOCUMENT OUTLINES HOW
TO GET IT RIGHT.
SO, WE DID -- THIS WAS PUBLISHED
IN JUNE 30, 2023.
THERE WAS A FIRST VERSION BEFORE
CHRISTMAS, WE WANTED TO GET
SOMETHING TO THE COMMUNITY SO
TEAMS COULD SEE PARTLY HOW TO
GET IT RIGHT.
WE MADE IT ACCESSIBLE IN FORMATS
SO THE ACCESSIBLE COMMUNITY
COULD SEE IT, HTML AND PDF.
1336 VISITS TO VIEW THAT
DOCUMENT.
AND WE HAD TWO WEBINARS ON BEST
PRACTICES, REGISTRATION
APPROACHED 300.
DISTRIBUTION YOU CAN SEE BELOW,
BROADLY DISTRIBUTED BY OUR
PARTNERS, OUR GOAL WAS TO GET IT
OUT TO MANUFACTURERS SO THEY
COULD SEE AND IT WAS PRETTY
BROADLY DISTRIBUTED.
IT HAS AN EXAMPLE ON THE RIGHT
OF READING LAYOUT WHERE -- I'LL
EXPLAIN TO YOU THE READING
FORMAT ON THE LEFT OF THAT
CHANGES FORMAT IN THE MIDDLE,
DOESN'T WORK WELL WITH ANY OF
THE ASSISTIVE TECHNOLOGIES
BECAUSE IT GOES ALL THE WAY
ACROSS AND BACK.
THE BEST WAY IS COLUMN FORMAT
MAKING THEM AS WIDE AS THE BREAK
POINT ON A FLAT BED SCANNER FOR
EXAMPLE TO USE OTHER ASSISTIVE
TECHNOLOGIES TO READ THIS.
IT HIGHLIGHTS THINGS LIKE THAT.
I WANTED TO TALK ABOUT OUR
COLLABORATION.
WE SPENT A LOT OF TIME WITH
ADVOCACY GROUPS.
WE COULD SOLICIT INPUT AND
EXPLAIN WHERE WE WERE IN MONTHLY
MEETINGS.
THERE'S A NUMBER OF THINGS,
HERE'S A FEW EXAMPLES.
AT ONE POINT IT WAS OFFERED THAT
THERE'S AN EXISTING TECHNOLOGY
USING RFID THAT IS ALREADY IN
USE FOR THE INDUSTRY, GOES WITH
THE PILL BOTTLE, GO TO THE
PHARMACY AND CAN PUT IT IN A
DEVICE AND WILL READ BACK THE
INSTRUCTIONS, THEY SUGGESTED
PERHAPS THAT'S AN ANSWER.
WE MET WITH COMPANIES THAT
MANUFACTURED THAT TECHNOLOGY TO
EXPLORE IT BECAUSE WE CURRENT
TAKE IT AT FACE VALUE AND FIGURE
OUT IMPLEMENTATION THAT FIT WITH
THE EXISTING INFRASTRUCTURE.
IT ENDED UP NOT TO BE THE CASE
BECAUSE YOU WANTED TO GO AT HOME
AND HEAR THE INSTRUCTIONS AT
HOME AND NOBODY HAS AN RFID
READER AT HOME.
THAT DIDN'T WORK OUT.
WE HAVE QUESTIONS AROUND
ASSISTIVE TECHNOLOGY,
PARTICULARLY BRAILLE DISPLAYS,
TRANSLATING WRITTEN INTO BRAILLE
FOR THE BLIND AS WELL AS
TECHNOLOGIES THAT DOES OCR AND
READS BACK, WHICH ARE CALLED
SCREEN READERS.
WE ASKED HOW BIGS, HOW MANY, HOW
OFTEN ARE THEY USED.
AND WE COULDN'T GET ACCURATE
RESULTS OR ANSWERS FROM THE
GROUPS SO WE MET WITH
MANUFACTURERS AS WELL TO SIZE
THE MARKET, WHO HAD THEM, HOW
MANY HAD THEM, WAS THIS
SOMETHING, HOW TO PUSH THIS.
AND THERE'S SURPRISING RESULTS.
ONE WAS THAT OFTENTIMES BRAILLE
IS CONSIDERED A GOOD SOLUTION
FOR THE BLIND COMMUNITY.
IT ENDS UP 10% OF THE BLIND
COMMUNITY CAN ACTUALLY READ
BRAILLE SO IT'S A RELATIVELY
SMALL GROUP.
IT'S A VERY LARGE FORMAT, A
QUARTER INCH PER SQUARE CARE.
IF YOU TAKE A QRI FOR
INSTRUCTION, WALL PAPER, IF YOU
LOOK AT SCREEN READERS, WE SPOKE
WITH THEM AND LEARNED THAT THE
UNEMPLOYMENT RATE, SCREEN
READERS ARE HUNDREDS TO
THOUSANDS OF DOLLARS, SEVERAL
THOUSANDS FOR THE NICE ONES.
AND THE TECHNOLOGY IS COOL AND
YOU CAN ADD THINGS AND HOOK UP
THINGS, ALL THIS IS POSSIBLE BUT
THE UNEMPLOYMENT RATE IN THE
BLINDNESS COMMUNITY IS AROUND
75%, AND SO THE ABILITY TO
AFFORD TECHNOLOGY BECOMES AN
EVEN BIGGER CHALLENGE AND FOCUS
ON COST.
WE LEARNED OTHER THINGS GOING
THROUGH THE PROCESS.
WE TALKED TO THE NATIONAL
LIBRARY SERVICE TO UNDERSTAND
WHAT THE FEDERAL GOVERNMENT WAS
DOING BECAUSE IT FLOATS DOWN TO
STATE LIBRARIES IN TERMS OF
DISSEMINATION OF FREE
ACCESSIBILITY TECHNOLOGY TO SEE
WHERE THEY WERE, WHICH IS VERY
LARGE INITIATIVE BUT IT'S
SOMEWHAT FRAGMENTED IN
IMPLEMENTATION.
WE INDIVIDUALLY MET WITH
ORGANIZATIONS TO UNDERSTAND
THEIR INTERESTS, ALSO RESOURCES
THEY COULD BRING TO BEAR TO HELP
US AND IMPORTANTLY AS WE DID
BEST PRACTICES AND THINGS TO GET
OUT, WE ESTABLISHED REGULAR
MARKETING COMMUNICATIONS
MEETINGS WITH MARKETING
COMMUNICATION TEAMS FROM THE
ADVOCACY GROUPS MEET WITH OUR
TEAM TO FIGURE OUT STRATEGIES,
WHAT THEY COULD SAY, WHERE THEY
COULD SAY IT, ET CETERA.
AND THEN OF COURSE THEY WERE
CONNECTING US ALL ALONG WITH
OTHER RESOURCES IN THEIR NETWORK
BECAUSE THEY WERE THERE AND I
CAN SAY WITHOUT THEM IT WOULD
HAVE TAKEN MUCH LONGER AND I'M
NOT SURE WE COULD HAVE GOTTEN TO
WHERE WE GOT TO IN THIS PROCESS
THEY WORKED IN THEIR COMMUNITIES
TO PUSH OUR MESSAGE.
THEY HAVE HAD MEETINGS, WE'VE
MED WITH GOOGLE, MICROSOFT,
AROUND A.I. AND OTHER
TECHNOLOGIES THAT MIGHT BE
ASSISTIVE IN THIS SPACE AND GOT
MIXED RESULTS, SOME LUKEWARM,
SOME PLAIN COLD.
THEY ALSO HAVE MEETINGS, VERY
LARGE MEETINGS WITH THOSE
GROUPS, AND THEY PUSHED THE
AGENDA THAT WE WERE ON WITH
THOSE GROUPS AS WELL TO HELP US
IN THAT SPACE SO THAT WAS
SOMEWHAT UNIQUE.
AT FIRST BLUSH THEY TELL YOU
WHAT TO DO AND BUILD A PRODUCT.
IF YOU BUILT PRODUCT BEFORE
THAT'S NOT HOW IT WORKS EXACTLY.
THIS IS A BALANCING ACT,
BALANCING STAKEHOLDERS.
WE HAVE ADVOCACY GROUPS, AND FDA
WANTS IT TO BE SAFE AND
EFFECTIVE, AND COMPANIES HAVE TO
BE -- IT HAS TO BE PROFITABLE AT
SOME LEVEL, SUSTAINABLE, ET
CETERA.
WE'RE TRYING TO BALANCE
INTERESTS TO SOME UP WITH
SOLUTIONS ACCEPTABLE TO GROUPS
AND OTHER STAKEHOLDERS.
SO THE TAKEAWAYS FROM THE
PROGRAM TO DATE, I THINK AS
FOLLOWS.
THERE REALLY AREN'T GOOD
STANDARDS FOR MANY OF THE AREAS
THAT ARE ADDRESSED IN
ACCESSIBILITY.
THIS STUFF ISN'T TECHNICALLY
HARD BUT IT'S NUANCED.
YOU HAVE TO KNOW HOW TO APPROACH
IT.
YOU CAN'T JUST SAY LET'S BUILD
ONE AND WE'RE ACCESSIBLE AND
PUTTING ON GOGGLES AND MITTENS
WON'T MAKE YOU BLIND AND HAVE
ARTHRITIS.
IT'S NUANCE AND TAKES WORK.
THE ADVOCACY GROUP SUPPORT WAS
ESSENTIAL FOR OUR SUCCESS, GAVE
US CONTEXT, THEY GAVE US
QUESTIONS, THEY GAVE US LEADS.
THEY HELPED -- WE HAD
DISCUSSIONS WITH POLICY PEOPLE
THAT BROUGHT US INTO OTHER
AGENCIES, ET CETERA.
IT WAS CRITICAL TO INVOLVE THE
ACCESSIBILITY POPULATION AS WELL
IN THESE.
WE HAD TO DIRECTLY INVOLVE THAT
POPULATION.
THE GENERAL ARGUMENT FOR THE
ENHANCEMENTS, YOU SAW IN THE
SECOND SLIDE A NUMBER OF
DIFFERENTED ADVOCACY GROUPS WE
MET WITH.
WITH DISABILITIES IN GENERAL,
NATIONAL FEDERATION OF THE
BLIND, DIFFERENT INTERESTS THAT
OVERLAP HEAVILY BUT NOT
COMPLETELY, ARGUING IMPROVING
PRODUCTS FOR ONE IMPROVES FOR
ALL AND IN GENERAL THAT
PRINCIPLE APPLIES FOR ALL OF US
THAT IF IT'S EASIER TO OPEN A
BOX FOR THEM EASIER FOR US AS
WELL, TO READ LABELS, RIGHT
CONTRAST RATIOS, FONT SIZE, ET
CETERA.
OVERALL THIS IS A BEACH HEAD
OPPORTUNITY TO HELP START IN A
PLACE TO RAISE AWARENESS OF
ACCESSIBILITY AND THEN
POSSIBILITIES BECOME MUCH
GREATER AS WE LOOK AT MEDICAL
DEVICES IN GENERAL.
THANK YOU.
[APPLAUSE]
>> I'M GOING TO LOOK TO THE
CHAIR, DO WE HAVE A COUPLE
MINUTES FOR QUESTIONS OR SHOULD
WE MOVE ON?
A FEW MINUTES.
IF YOU WANT TO HAVE ANY
QUESTIONS, I'LL HAVE A
PREROGATIVE TO ASK A QUESTION AS
PEOPLE ARE COMING UP.
RAPID FIRE SESSION, I DID NOT
PREPARE.
BLANK CHECK, RADx TECH, FILL
IN THE BLANK, WHAT'S OUR NEXT
HOT TOPIC TO FOCUS ON UNLIMITED
SUMS AND WHO WOULD YOU WANT TO
PARTNER WITH TO DO IT?
ANY QUESTIONS FROM THE AUDIENCE
IN THE MEANTIME?
OKAY.
LEAD US OFF.
>> I'M A SHY PERSON.
NIH CANNOT DISCLOSE ANY PLANNING
BEFORE IT'S PUBLIC.
BUT DEFINITELY POLITICALLY
CORRECT ANSWER, ANY GROUPS, ANY
OF THE GROUPS OR ORGANIZATIONS
THAT ARE IN THIS SPACE, TALKING
ABOUT THE HEALTH CARE WILL BE A
PERFECT PARTNER.
WE NEED TO BREAK THOSE BARRIERS
PREVENTING INDIVIDUALS BEFORE,
DURING AND AFTER DELIVERY TO GET
ACCESS TO QUALITY CARE AND TO
REDUCE MORBIDITY AND MORTALITY.
SO I WOULD SAY ANY OF
STAKEHOLDERS WILLING TO
PARTICIPATE IN ANY FUTURE
ITERATION OF SUCH AN ENDEAVOR IS
WELCOME BECAUSE WE A COMMON GOAL
AT STAKE.
>> I ASSUME NIBIB IS PART OF
YOUR DREAM TEAM.
>> ABSOLUTELY.
>> JUST MAKING SURE.
>> I THINK TACKLING HEALTH CARE
ACCESSIBILITY WOULD BE A DREAM.
THERE ARE -- YOU MENTIONED FOR
MATERNAL HEALTH THERE ARE
DESERTS, PEOPLE LACK RESOURCES
AND ACCESS TO HEALTH CARE.
AND POINT OF CARE TECHNOLOGY IS
ONE OF THE WAYS TO ADDRESS THAT.
AND SO I'M LEAVING IT KIND OF
OPEN AS TO WHAT EXACT DISEASE I
WOULD FOCUS ON, MOSTLY BECAUSE I
THINK THERE ARE SO MANY AND JUST
INCREASING ACCESS TO PRIMARY
CARE, AND OTHER TYPES OF HEALTH
CARE WOULD BE REALLY IMPACTFUL.
>> SO, MAYBE I THINK ABOUT IT
DIFFERENTLY, MORE HORIZONTALLY.
I THINK SOME OF THE INITIATIVES
WE'VE UNDERTAKEN LIKE
ACCESSIBILITY AND OTHERS MIGHT
BE ABLE TO BE APPLIED ACROSS
MULTIPLE TECHNOLOGY TYPES, AND I
THINK THAT COULD BE IMPACTFUL.
WE'VE DONE IT.
AND WE KNOW WHAT RESOURCES ARE
AND WHAT IT TAKES TO DRIVE THAT
SO IT BECOMES FAIRLY WELL
CHARACTERIZED DEPENDING HOW FAR
YOU WANT TO GO.
I WOULD PERHAPS THINK ABOUT
THAT.
>> I SEE NO OTHER QUESTIONS.
LET'S THANK OUR PANEL AND LET
THE NEXT GROUP COME UP.
THANK YOU VERY MUCH.
[APPLAUSE]
>> FEDERAL AND NON-FEDERAL
RESOURCES FOR INVESTORS, WITH A
DISTINGUISHED PANEL, BRIEF
INTRODUCTIONS, BOB STOREY
MANAGING PARTNER OF A BALTIMORE
VENTURE DEVELOPMENT COMPANY, MED
TECH COMPANIES AND TRAIN EARLY
MANUFACTURING STAGES.
FIELD OF CARDIOLOGY, SURGERY,
HEMODIALYSIS, VICE CHAIR FOR
MARYLAND LITHE SCIENCE ADVISORY
BOARD, EXECUTIVE IN RESIDENCE AT
HOPKINS.
WITHIN NIH PORTFOLIO EXECUTIVE
FOR RADx, BLUEPRINT MED TECH
INITIATIVE, LEAD INSTRUCTOR FOR
I-CORPS AT NIH.
LED INTERNATIONAL COHORTS.
NEXT TO BOB IS CHRIS SASIELA,
WORKED AROUND NIH SINCE POSTDOC
AT NIH, EXTRAMURAL IN 2012,
REGULATORY SPECIALIST AT NHLBI
BEFORE BECOMING A MEMBER OF THE
SEED OFFICE, DIRECTOR OF
INNOVATION AND SUPPORT SERVICES,
VARIETY OF PROGRAMMING TO
EDUCATION AND ENABLE NIH-FUNDED
INNOVATION, BUSINESS STRATEGY,
REIMBURSEMENT, REGULATORY
AFFAIRS, THINGS YOU STARTUPS
MIGHT BE INTERESTED IN.
REBEKAH NEAL JOINED VENTURE WELL
IN 2012, MED TECH AND
DIAGNOSTIC, CHALLENGE
ADMINISTRATION, BOARD
ADMINISTRATION, TEAM THERE WHICH
SUPPORTS SEVERAL NIH ACTIVITIES
OUT OF NIBIB, INCLUDING RADx,
THE COMMERCIALIZATION CENTER,
AND AWARD MANAGEMENT, DESIGN --
PART OF OUR DEBUT CHALLENGE FOR
UNDERGRADUATES WITH FOCUS ON
ADVANCING ENTREPRENEURSHIP AND
SCIENCE TECHNOLOGY, WAS A
PROGRAM MANAGER AT BILL AND
MELINDA GATES FOUNDATION.
LAST IS KARI ASHMONT,
TRANSLATION TEAM AT NIBIB, CAME
TO US IN 2022, MANAGES SMALL
BUSINESS PROGRAM AND SUPPORTS
RADx PROGRAM, ESPECIALLY
MATERNAL HEALTH INITIATIVES,
BRAIN INITIATIVE AND JOINED NIH
IN 2017 AND PREVIOUSLY A PROGRAM
DIRECTOR AT NINDS, OVERSAW
TRANSLATIONAL AGREEMENTS AND RAN
BLUEPRINT FOR NEUROSCIENCE
INITIATIVE R25 TRAINING PROGRAM.
I HAVE A FEW SLIDES MYSELF.
WE'LL JUMP IN.
I'VE INSTRUCTED THEM TO TAKE TEN
MINUTES OR LESS SO WE'LL HAVE 20
MINUTES FOR QUESTIONS AND
ANSWERS.
THIS IS A GREAT PANEL TO ANSWER
QUESTIONS HOW TO TAKE THE FIRST
STEPS OUT OF THE LAB AND INTO
STARTING TO DEVELOP PRODUCTS AND
EVENTUALLY GETTING TO MARKET.
SO THE THINGS YOU NEED TO GET TO
MARKET ARE MONEY, ASSISTANCE,
AND LUCK.
WE'RE ONLY COVERING THE MIDDLE
GROUND HERE, CHRIS AND KARI
WILL TALK ABOUT FEDERAL THINGS.
I'LL GIVE NOTES ABOUT FEDERAL
GRANTS BUT THERE'S PRIVATE
CAPITAL.
POCTRN ISSUES SOLICITATIONS.
WE HAVE NOT POSTED FOR 2023,
RECENTLY RECOMPETED THE CENTERS.
BLUEPRINT MED TECH, MY BABY,
WITH NICK LANGHAUL AND SEVERAL
OTHERS, HE'S HERE IF YOU WANT TO
ASK ABOUT DEVICES THAT INTERSECT
BETWEEN DIAGNOSTICS AND
DISORDERS OF THE NERVOUS
SYSTEMS.
ALSO REPRESENTED ARE REACH HUBS,
MORE REGIONAL FOCUSING ON STATES
AND REGIONS BUT CERTAINLY THE
SIMILAR INCUBATION-STYLE
PROGRAMS.
THE WORLD DOES NOT ENDS AT NIH'S
DOORS, OUR FRIENDS AT BARDA HAVE
AN ACCELERATOR NETWORK CURRENTLY
RECOMPETING, KEEP YOUR EYES
PEELED FOR HUBS SOLICITING AND
FUNDING PROJECTS IN THE IVD
SPACE.
THROUGH THE OTHER INVESTIGATOR
OPEN SOLICITATION, TAKE A LOOK
AT THE DRIVE WEBSITE.
AND OUR FRIENDS AT DTRA HAVE A
MENTOR PROTEGÉ PROGRAM TO
PARTNER WITH A LARGER
ORGANIZATION.
SO, PASSING THE BATON LET'S LOAD
BOB'S DECK AND MOVE FROM THERE.
>> THANK YOU, MICHAEL.
IT'S GOOD TO SEE SO MANY NIH
RADx AND NEUROTECH FRIENDS IN
THE AUDIENCE.
I'M REAL PLEASED TO BE HERE
TODAY.
AS MICHAEL MENTIONED, I SPEND A
LOT OF TIME IN INVESTMENT
COMMERCIALIZATION AND ECONOMIC
DEVELOPMENT.
AND SO I WANTED TO TALK ABOUT
SOME OF THE -- MAYBE TO SET THE
STAGE FOR A LOT OF RESOURCES
WE'RE GOING TO TALK ABOUT.
I WANT TO GIVE BACKGROUND, MAYBE
A LITTLE SETUP FOR SOME OF THE
ISSUES THAT THE PEOPLE FACE AS
THEY MOVE INTO THIS
TRANSLATIONAL PHASE.
MOST OF THE THINGS WE'RE GOING
TO TALK ABOUT ARE PRE-EQUITY
INVESTMENT, ALL THE PREPARATION
TO GET THROUGH, THE SUPPORT
NEEDED TO DEMONSTRATE TO THE
THIRD PARTY INVESTORS YOU HAVE A
STRAIGHT PATHWAY TO EVENTUAL
SUSTAINABILITY.
I LIKE TO START -- I THINK
I'M -- WITH INTRODUCTION.
THIS IS MY -- MY OFFICES ARE IN
DOWNTOWN BALTIMORE AT THE INNER
HARBOR, I LIVE IN ANNAPOLIS.
THAT'S THE NAVAL ACADEMY.
SO ALMOST ALL OF MY STORIES HAVE
A NAUTICAL THEME.
I'M A BOATER.
MOST TECHNOLOGIES WHEN THEY GO
THROUGH TRANSLATION INITIALLY
GO THROUGH A START-UP PHASE.
MOST STRATEGICS, MOST POTENTIAL
EXIT PARTNERS LIKE TO SEE THE
FIRST STEPS OF DEMONSTRATION
THROUGH A START-UP EVEN IN A
BRIEF PERIOD OF TIME, SO MANY OF
YOU GOING THROUGH THIS
TRANSLATIONAL STEP WILL BE
TAKING YOUR TECHNOLOGY THROUGH
SOME SORT OF EARLY STAGE
START-UP OR OPPORTUNITY.
AND A LOT OF PEOPLE THINK THAT A
START-UP IS JUST -- IT'S A FUN
TIME, IT'S A PART PARTY IN THE
BAHAMAS, UNFORTUNATELY MOST
STARTUPS END UP AS A BOAT FIRE.
A LOT OF THINGS YOU HEARD FROM
BRIAN WALSH THERE ARE COMPLEX
STAKEHOLDERS.
TRYING TO ADDRESS THOSE
REQUIREMENTS, VALIDATING WHAT IT
TAKES TO SATISFY THOSE
STAKEHOLDERS IS A BIG EFFORT
BEYOND VERY GOOD TECHNOLOGY OR
CLINICAL EVIDENCE.
AND SO WE TALK ABOUT IT.
YOU'VE HEARD ABOUT THE IDEA OF
THE VALLEY OF DEATH.
THIS PATHWAY TO GET FROM VERY
GOOD CLINICAL INFORMATION TO
ACTUALLY GETTING TO THE BEDSIDE,
AND IT'S MAN TESTED BY A SERIES
OF EVENTS NECESSARY TO RAISE
FUNDS TO GET YOU PAWS -- PAST
THAT INITIAL STATE.
FAIRLY SAFE ENVIRONMENT, FEDERAL
FUNDING, FUNDING AT INSTITUTION,
SECURE JOB, TENURE PERHAPS.
AS YOU MOVE INTO THE MORE CASH
INTENSIVE ACTIVITIES, MAYBE
TECHNOLOGY, DEVELOPMENTS,
OBVIOUSLY A LOT OF CLINICAL
WORK, A LOT OF VALIDATION
NECESSARY WITH STAKEHOLDERS
DURING THAT PROCESS, THAT
CONSUMES CASH AND THAT CASH IS
MADE UP BY A SERIES OF SPONSORS,
FUNDERS, INVESTORS.
THAT'S THE VALLEY OF DEATH
BECAUSE YOU HAVE TO CONVINCE
FOLKS YOU HAVE A REASONABLE
PATHWAY TO SUSTAINABILITY THAT
GETS MORE CHALLENGING AS COMPANY
OR CONCEPT MATURES.
THOSE IN THE START-UP SPACE WE
CALL THAT THE TROUGH OF SORROW,
BECAUSE GENERALLY YOU'RE EXCITED
WHEN YOU GET STARTED, YOU RUN
INTO CHALLENGES.
AND UNTIL YOU GET TO A REAL
DEMONSTRATION OF PRODUCT MARKET
FIT AND PROCEED INTO
SUSTAINABILITY, IT IS A VERY
DIFFICULT PATHWAY.
YOU NEED A LOT OF SUPPORT.
YOU NEED A NETWORK TO TAP INTO
TO RAISE YOUR PROBABILITY OF
SUCCESS.
WE GENERALLY LOOK AT THE
PROGRESSION OF LIFE SCIENCES,
TECHNOLOGY, STARTING WITH THE
CLEAR STATION, PATIENT
INDICATION, NEED, ENVIRONMENT,
THAT'S DELIVERED IN.
AND WE LOOK CAREFULLY AT WHAT
THE EXISTING PROCESSES ARE,
YOU'RE FAMILIAR WITH THOSE VERY
LIKELY IN YOUR FIELD.
BUT THEN WE START TO GET INTO
THE COMPLEXITIES OF THE
STAKEHOLDERS, HOW DO WE VALIDATE
WHAT STAKEHOLDERS' NEEDS ARE,
HOW TO IDENTIFY CRITICAL
ACTIVITIES NECESSARY TO VALIDATE
THEIR VALUE PROPOSITIONS AND THE
MONEY THAT'S REQUIRED TO GET
THROUGH ALL OF THE STAGES
EVENTUALLY TO THE SUSTAINABILITY
POINT.
AND THAT FEELS LIKE A FIRE
HYDRANT.
IF YOU'RE NEW IN THE INNOVATION
SPACE, IT SEEMS THAT THERE'S SO
MUCH INFORMATION YOU HAVE TO
COVER, SO MUCH YOU HAVE TO KNOW,
YOU WANT TO WORK ON YOUR
CLINICAL SIDE OR TECHNICAL SIDE,
HOW DO I APPROACH GETTING
SUPPORTS NECESSARY TO MAKE IT
DOWN THIS PATHWAY AND ACROSS THE
VALLEY OF DEATH.
FORTUNATELY, WE UNDERSTAND
PRETTY WELL ABOUT THE DIFFERENT
STAGES THAT TECHNOLOGY GOES
THROUGH FROM ACADEMIC INITIATED
VENTURE, THE SORT OF
DEMONSTRATIONS NECESSARY,
FORMATION OF A SEARCH SIDE, YOU
GO THROUGH VALIDATION TO
DEMONSTRATE THAT FIT, AND AS YOU
PROGRESS INTO THE RIGHT HALF OF
THE PROCESS, WHAT THE
EXPECTATIONS ARE, HOW YOU BUILD
YOUR TEAM, HOW YOU EXECUTE, SO
THE GOOD NEWS IS THERE IS A
PRESCRIPTIVE PROCESS.
WE KNOW WHAT SUPPORT IS NEEDED
AS YOU GO THROUGH THIS PROCESS.
THERE'S NO SILVER BULLET,
WHETHER YOU'LL BE SUCCESSFUL OR
NOT, BUT THERE ARE LOTS OF
THINGS TO IMPROVE THE
PROBABILITY THAT YOU HAVE A
BETTER CHANCE OF SUCCESS VERSUS
THE COMPETITIVE OFFERINGS YOU
MAY BE UP AGAINST AS YOU GO TO
THE MARKET.
SO I WANT TO TALK ABOUT A
COUPLE.
OF THE RESOURCES TO CONSIDER
MOVING DOWN THIS PATHWAY.
THIS IS ABOUT NETWORKING,
ESTABLISHING OFTEN TIMES
CONNECTIONS WITH PEER GROUPS,
OUTSIDE OF PEER GROUPS AND
ORGANIZATIONS THAT YOU MAY NOT
HAVE CONVENTIONALLY INTERACTED
WITH BUT THEY FALL INTO THE
SUPPORT INSTITUTIONALLY THAT HAS
BEEN GROWING SUBSTANTIALLY OVER
THE PAST COUPLE DECADES.
WE'LL TOUCH ON THAT FOR A
MOMENT.
THEN THERE'S A SURPRISING AMOUNT
OF ECONOMIC DEVELOPMENT SUPPORT
THAT'S OUTSIDE OF THE
INSTITUTIONS THAT ARE REGIONALLY
FOCUSED, PROVINCIAL IN TERMS OF
COMMITMENT TO REGIONS AND
TREATMENT RESOURCES THAT CASCADE
OUT OF THOSE ORGANIZATIONS AS
WELL.
SO STARTING FIRST ON THE
INSTITUTIONAL SIDE, MANY OF YOU
ARE WORKING WITH YOUR TECH
TRANSFER ORGANIZATIONS AT YOUR
INSTITUTIONS.
AND THIS IS A GROUP THAT HAS
CONSIDERABLY EVOLVED OVER THE
PAST DECADE OR SO.
PROBABLY TWO DECADES, THAT THEY
ARE NOW OPERATING MORE AS TECH
VENTURES OPERATIONS.
IF YOU HAVE -- YOU MAY HAVE
EXPERIENCE GOING AND FILING YOUR
INVENTION DISCLOSURE, TALKING
ABOUT LICENSING, ALMOST ALL
ORGANIZATION AT MANY INTUITIONS
HAVE IMPLEMENTED SIGNIFICANT
MENTORSHIP PROGRAMS, MAY OPERATE
INNOVATION TRAINING THAT'S
USEFUL IN THE EARLY STAGES, MANY
HAVE GREAT CONNECTIONS AND
UNDERSTANDING OF WHAT THE
ECOSYSTEM IS IN THEIR REGION
THAT CAN GIVE ADDITIONAL TOOLS.
AN EXAMPLE ABOUT JOHNS HOPKINS
AND TRANSFORMATION IN THE PAST
TEN YEARS, TECH TRANSFER
ORGANIZATION ABOUT TEN YEARS AGO
WAS TRANSFORMED INTO BEING
RESPONSIBLE FOR THE PATENT
DEVELOPMENT, LICENSING,
INCUBATORS, THE INNOVATION
TRAINING PROGRAMS, MANAGEMENT OF
THE TRANSLATIONAL PHILANTHROPIC
FUNDS WE HAVE ACCESS TO, AND
COORDINATING WITH SOME OF THE
REGIONAL AND FEDERAL INVESTING
PROGRAMS THAT EXIST THROUGHOUT
THE COUNTRY.
A ONE-STOP SHOP FOR AN INNOVATOR
STARTING TO LOOK AT THEIR
OPPORTUNITIES COMING DOWN THE
ROAD.
THIS STORY IS REPEATED AT MANY
INSTITUTIONS.
THAT'S THE TREND.
IF YOU HAVEN'T HAD THAT DEPTH OF
CONVERSATIONS IT'S SOMETHING TO
PUT ON THE LIST TO DO QUICKLY.
WE'LL HEAR FROM REBEKAH ABOUT
THINGS THAT VENTUREWELL IS
INVOLVED IN, BUT A NETWORK
EXISTS OUT OF THE COUNTRY, A LOT
GREW OUT OF NATIONAL SCIENCE
FOUNDATION PROGRAMS,
ESTABLISHING HUBS AND SITES
AROUND THE COUNTRY, THAT WERE
INVOLVED IN VARIOUS INNOVATION
TRAINING.
BUT THERE ARE THREE, FOUR
THOUSAND TEAMS THROUGHOUT THE
COUNTRY GREAT RESOURCES, PEOPLE
EVEN NETWORK WITH DOWN THIS
PATHWAY PERHAPS BEFORE AND
REBEKAH WILL TALK ABOUT HOW
IMPORTANT SOME OF THESE
CONNECTIVE TISSUES ARE IN TERMS
OF SUPPORTING AS YOU GO FORWARD.
ECONOMIC DEVELOPMENT POINT OF
VIEW I'M SURPRISED RESEARCHERS
ARE NOT AWARE HOW MUCH IS GOING
ON AT THE STATE LEVEL IN A LOT
OF CASE IS.
YOU CAN LOOK UP YOUR BIOSCIENCE
ASSOCIATION FOR YOUR STATE AT
THE COUNCIL OF STATE
BIOSCIENCES, ANOTHER AREA THAT
HAS CHANGED IN THE PAST TEN OR
TWENTY YEARS, MOST CAME OUT OF
THE ADVOCACY AREA, FOCUSED ON
LOCAL LEGISLATURE, BUT THEY HAVE
EVOLVED TO BE INNOVATION AND
INNOVATOR SUPPORT ORGANIZATIONS
IN ALMOST EVERY STATE.
I THINK EVERY STATE IS
REPRESENTED BY A BIOSCIENCE
ASSOCIATION.
YOU'LL FIND MANY HAVE PROGRAMS,
MENTORSHIP PROGRAMS, THAT THEY
HAVE ACCESS TO LOCAL FUNDING IN
MANY CASES TO SUPPORT
TRANSLATION, AND I WOULD
RECOMMEND IF YOU'RE LOOKING TO
GO DOWN THIS PATHWAY, JOINING
THESE ASSOCIATIONS,
UNDERSTANDING WHAT'S HAPPENING
OUTSIDE OF JUST THE UNIVERSITY
OR INSTITUTIONAL LEVEL.
THEY ARE TREMENDOUS RESOURCES
AND I KNOW IN OUR REGION THEY
WERE VERY ACTIVE AND TIE PEOPLE
INTO GREAT SUPPORT.
IN ADDITION TO ORGANIZATIONS
THERE ARE A SERIES OF WHAT I
CALL PROVINCIAL INVESTMENT
ORGANIZATIONS THAT EXIST
THROUGHOUT THE COUNTRY.
IN MARYLAND TEDCO IS THE FUNDING
ARM OF THE STATE OF MARYLAND.
THEY ARE ALLOWED TO TAKE EQUITY
INVESTMENT IN COMPANIES.
BUT ALMOST EVERY STATE HAS
SOMETHING THAT'S EXTRACURRICULAR
FROM THE BIOSCIENCES
ASSOCIATIONS THAT ARE OFTENTIMES
FUNDED BY EITHER INSTITUTIONAL
OR STATE PROGRAMS TO SUPPORT
TECHNOLOGIES WITHIN THAT STATE
OR REGION.
AND THIS IS AN ECONOMIC
DEVELOPMENT EFFORT THAT'S
DIFFERENT APPROACH THAN YOU
MIGHT RUN INTO IF YOU'RE DEALING
WITH A VENTURE INVESTOR, PURE
FINANCIAL INVESTOR, EVEN A
FEDERAL GRANTEE PROGRAM IS THEY
ARE BIASED BY THEIR NEED TO
SUPPORT WHAT IS HAPPENING IN
THEIR REGION.
SO THESE ARE OTHER AREAS
CRITICAL TO EXPLORE AGAIN
GENERALLY THE TECH VENTURE
ORGANIZATIONS THAT INSTITUTIONS
OR BIOSCIENCE ASSOCIATIONS
ARE -- AM I LOOKING FOR A LIGHT?
YES.
ARE AVAILABLE FOR YOU TO GET TO.
AS THE PROJECTS MATURE, THERE
ARE OTHER THINGS YOU CAN TAP
INTO.
LAUNCH PORT WHICH IS OUR VENTURE
COMPANY SUPPORTS TECHNOLOGIES
COMING OUT OF INCUBATION TO HELP
DOWN MANUFACTURING PATHWAY AND
SERIES OF NATIONAL PROGRAMS TO
HELP STARTUPS GET MENTORSHIPS,
MED TECH INNOVATORS IS THE
BIGGEST MEDICAL ACCELERATOR FOR
BOTH DIAGNOSTICS AND MEDICAL
DEVICES, AFFILIATED WITH THE
NATIONAL MEDICAL DEVICE
ORGANIZATION.
I'M GOING TO STOP THERE AND TURN
IT OVER.
I HAVE EXAMPLES OF WHAT WE HAVE
DONE IN MARYLAND, WE'VE HAD A
PROGRAM TO INTEGRATE ALL OF
THOSE DIFFERENT AREAS, DIFFERENT
RESOURCES, HARMONIZE THEM FOR A
TRANSLATIONAL INNOVATOR THAT'S
MOVING THROUGH THAT PATHWAY,
THAT TAPS THEM INTO EVERY ONE OF
THOSE MENTORSHIP PROGRAMS AS
TECHNOLOGY MATURES.
I'LL LEAVE IT THERE.
[APPLAUSE]
>> WE'RE THE CENTRALIZED OFFICE
THAT MANAGES THE SMALL BUSINESS
PROGRAMS FOR NIH AND HHS IN SOME
CASES, OTHER SISTER AGENCIES.
IN ADDITION TO PROVIDING MONEY,
ADMINISTRATION OF POLICY AND
REPORT WE GO PROVIDE A VAST
NUMBER, VAST COMPARED TO OTHER
FEDERAL AGENCIES, SUPPORT
SERVICES FOR INNOVATOR
COMMUNITY.
I'LL SPEND TIME TALKING ABOUT
THOSE.
SOME OF THOSE PROGRAM ALSO
INVOLVE MONEY.
MONEY IS ALWAYS A GOOD THING.
FOR THOSE WHO MAY HAVE A SMALL
BUSINESS ALREADY, WE HAVE AN
INNOVATION CORE PROGRAM, I-CORPS
PROGRAM AT NIH, BOB DESCRIBED
HIS INVOLVEMENT IN THAT.
FOR NIH, WE REQUIRE THREE MEMBER
ENTREPRENEURIAL TEAMS, THE
PROGRAM RUNS FOR 8 WEEKS, YOU
ARE EXPECTED TO MINIMIZE YOUR
TIME IN THE LAB, MAXIMIZE TIME
DURING THAT IMPORTANT THING THAT
BOB JUST MENTIONED, NETWORKING.
FINDING OUT WHAT YOUR CUSTOMERS
NEED, WHO KEY STAKEHOLDERS ARE,
WHAT YOU NEED TO DO TO ENGAGE
THEM IMPACTFULLY TO STREAMLINE
YOUR DEVELOPMENT.
WE ALSO HAVE AN ADMINISTRATIVE
SUPPLEMENT TO PROMOTE DIVERSITY.
THIS IS SOMETHING IF YOU HAVE
IDENTIFIED A MEMBER OF YOUR
SCIENTIFIC COMMUNITY,
ENTREPRENEURIAL COMMUNITY THAT
YOU WOULD LIKE TO INCLUDE IN
YOUR PROGRAM, YOUR PROJECT, YOUR
COMPANY, YOU CAN APPLY FOR
ADDITIONAL X AMOUNT OF FUNDING
TO BRING THAT PERSON IN TO
ENHANCE THE DIVERSITY OF YOUR
COMPANY AND THE PROGRESS OF YOUR
TECHNOLOGY.
THE SUPPLEMENTS MUST BE TO
SUPPORT WORK WITHIN THE SCOPE OF
THE ORIGINAL PROJECT, AND THEY
ARE ACCEPTED ON A ROLLING BASIS,
DEPENDING WHICH INSTITUTE OR
CENTER THEY MAY ALL BE REVIEWED
TOWARDS THE END OF THE FISCAL
YEAR.
THERE IS SOMETHING THAT IS PART
OF THE SMALL BUSINESS PROGRAM
FOR QUITE SOME TIME, BUT IN THE
MOST RECENT REAUTHORIZATION THE
AMOUNT OF MONEY PUT TOWARDS IT
WAS SIGNIFICANTLY INCREASED.
THIS IS THE TECHNICAL AND
BUSINESS ASSISTANCE FUNDING OR
IN OUR CASE PROGRAMS BECAUSE
SOME IS FUNDING, SOME IS NOT
FUNDING, THAT COMES AS PART OF A
SMALL BUSINESS AWARD.
SO THIS IS AVAILABLE TO PHASE 1
AND PHASE 2 SMALL BUSINESSES, IF
YOU DON'T KNOW WHAT THAT MEANS
PHASE 1 IS PROOF-OF-CONCEPT, A
QUARTER MILLION TO $300,000
PROJECT, EXPECTED TO TAKE 6 TO 9
MONTHS TO COMPLETE.
IF THAT FEASIBILITIES PLAYS OUT
YOU CAN APPLY FOR PHASE 2
FUNDING, MORE ON THE ORDER OF $2
MILLION, $1.05 TO $2 MILLION,
TWO TO THREE YEARS, FULLER
RESEARCH AND DEVELOPMENT
INITIATIVE, AFTER THAT PROOF OF
CONCEPT HAS COME THROUGH.
FOR PHASE 1 AWARDS, YOU ARE
ALLOWED TO REQUEST UP TO $6,500
PER YEAR OF YOUR AWARD, THAT'S
IMPORTANT BECAUSE IT'S DIFFERENT
FOR PHASE 2.
IF YOU HAVE A MULTI-YEAR PHASE 1
PROGRAM WHICH CERTAIN TIMES OF
TECHNOLOGIES LEAD THEMSELVES
TOWARDS, AGING TECHNOLOGIES, YOU
NEED RODENTS TO AGE FOR
INSTANCE, OR TIME FOR SOMETHING
TO PROVE OUT, THOSE MAY BE
MULTI-YEAR PROGRAMS AND YOU CAN
ASK FOR 6500 PER YEAR FOR THOSE
PROGRAMS.
FOR THE PHASE 2 AWARDS YOU CAN
ASK FOR $50,000, FOR THE ENTIRE
PROJECT PERIOD, REGARDLESS OF
ONE-YEAR PROGRAM OR FOUR-YEAR
PROGRAM, DOESN'T MATTER, $50,000
IS THE CAP.
THERE ARE INSTRUCTIONS ON HOW TO
REQUEST THOSE THAT ARE IN THE SF
424 APPLICATION GUIDE,
GOVERNMENT-ESE, EXCELLENT CURE
FOR INSOMNIA, IT'S ALSO THE
BIBLE FOR EVERY QUESTION YOU'RE
GOING TO ASK US.
WE'LL GO THERE, CUT AND PASTE
AND REPLY TO YOUR E-MAIL WITH
JUST THAT WORDING.
THOSE ARE THE MONEY OPTIONS FOR
THE TECHNICAL AND BUSINESS
ASSISTANCE.
HOWEVER, WE HAVE IN-KIND
PROGRAMS, SO FOR PHASE 1 IF YOU
HAVE NOT REQUESTED MONEY YOU CAN
DO ONE OR THE OTHER.
PROGRAM OR MONEY.
FOR PHASE 1, WHAT OUR OFFICE
PROVIDES IS ACCESS TO A TABBA
NEEDS ASSESSMENT, A THIRD PARTY
MEMBER TO MEET WITH THE TEAM,
TALK ABOUT YOUR PROJECT, DO AN
EVALUATION, FOR CRITICAL AREAS,
PROVIDE A REPORT, HELPING YOU
UNDERSTAND STEPS YOU NEED TO
MAKE MOST EMERGENT NEEDS AND
TIMELINE FOR SOME OF THE OTHERS.
FOR PHASE 2 WE HAVE A CONSULTING
SERVICES PROGRAM, NEEDS
ASSESSMENT HAS A ROLLING REQUEST
CYCLE, CONSULTING SERVICES IS
ONCE A YEAR, HIGHLY COMPETITIVE.
HOWEVER, IT IS AN ABSOLUTE GEM,
IF YOU'RE ACCEPTED WE HAVE A
CONTRACTOR WHO WILL HELP YOU
DEVELOP A SCOPE OF WORK,
IDENTIFY VENDORS, SOLICIT
PROPOSALS, AND THEN ENGAGE THE
CONTRACT ON YOUR BEHALF.
SO, THAT IS AN EXCELLENT
PROGRAM.
HOWEVER, UNFORTUNATELY, THE BEST
APPROACH IS ALWAYS FOR YOU TO
TAKE CONTROL OF YOUR PRODUCT
DEVELOPMENT WORK, AND PUT THE
MONEY IN YOUR PROPOSAL AND TELL
US HOW YOU'RE GOING TO SPEND
THAT.
NOW, THIS IS A VERY BUSY SLIDE.
I WON'T READ THE WHOLE THING.
I'LL ENCOURAGE YOU IF YOU'RE
LOOKING TO ENGAGE A VENDSOR TO
TAKE A LOOK AT SOME OF THOSE
SAMPLE SCOPE OF WORK DOCUMENTS
THAT ARE LINKED AT THE BOTTOM OF
THIS PAGE.
BEST WAY IS TO CLICK THE LINKS.
I DON'T HAVE QR CODES YET, IT'S
A GROWING OFFICE.
THESE WILL IDENTIFY NEEDS TO
FIND DELIVERABLES AND IDENTIFY
WHAT VENDOR QUALIFICATIONS ARE
MOST IMPORTANT FOR YOU AS YOU
MOVE INTO YOUR PRODUCT
DEVELOPMENT WORK.
SINCE I TALKED ABOUT THAT WHICH
CAN BE USED FOR ANY OF THE
FUNDING OPPORTUNITIES AND AS
PART OF THE TABA CONSULTING
SERVICES PROCESS I FIGURED I
WOULD THROW UP A LITTLE BIT OF A
TEASER, WHAT THOSE NEEDS
ASSESSMENT REPORTS LOOK LIKE.
THIS IS POSTED ON THE
APPROPRIATE WEBSITE, NIH NEEDS
ASSESSMENT PROGRAM.
YOU CAN TAKE A LOOK AND SEE HOW
THAT REPORT LOOKS AS IT WOULD
COME BACK AS AN INNOVATOR WITH A
PHASE 1 AWARD.
ALL OF THE WORK THAT WE DO IN
THE INNOVATOR SUPPORT SERVICES
TEAM IS PREDICATED ON OUR
INTERACTIONS WITH YOU, OUR
INNOVATOR COMMUNITY.
THOSE INTERACTIONS START AT A
ONE-ON-ONE BASIS, USUALLY IN THE
FORM OF A CONSULTATION.
WHAT'S A CONSULTATION?
YOU REMEMBER THAT NETWORKING
THAT BOB WAS TALKING ABOUT SO
IMPORTANT?
THIS IS THAT.
YOU DON'T HAVE TO PAY FOR IT OR
HAVE A RUBBER CHICKEN AND DRINK
A CHEAP GLASS OF WINE.
YOU CAN DO THIS FROM YOUR DESK.
WE HAVE ENTREPRENEURS IN
RESIDENCE AND SUBJECT MATTER
EXPERTS AVAILABLE TO YOU, YOU
HAVE ONE DOLLAR FROM NIH IN YOUR
POCKET, SEND ME AN E-MAIL, I'LL
GET YOU CONNECTED UP.
THESE ENTREPRENEURS IN RESIDENCE
BY AND LARGE HAVE WORKED SAT
FORTUNE 200 COMPANIES, STARTED
COMPANIES MULTIPLE TIMES, THEY
HAVE LEARNED THE LESSONS THAT
YOU'RE GOING THROUGH NOW.
AND THEY ARE GREAT RESOURCES.
THEIR NETWORKS INTO THE
INVESTMENT COMMUNITY, THE
MANUFACTURING COMMUNITY, THE
SCIENTIFIC COMMUNITY, THE
CLINICAL COMMUNITY, IS
UNPARALLELED IN THE FEDERAL
GOVERNMENT.
THESE ARE AMAZING PEOPLE.
AND ALL IT TAKES TO REQUEST TIME
IS AN E-MAIL AND DESCRIPTION OF
WHAT YOU WANT TO TALK ABOUT.
WE CAN MAKE THAT HAPPEN.
THESE ARE MY BUSINESS PEOPLE.
THEY TALK ABOUT COMPANY
FORMATION, BUILDING A TEAM,
BRINGING ON ADVISORS, HOW TO
DEVELOP A TERM SHEET, CREATE A
PRO FORMA TO TALK TO INVESTORS,
THEY COACH PEOPLE HOW TO PRESENT
A VALUE PROPOSITION WHEN TALKING
TO AUDIENCES OF ALL TYPES.
I ALSO HAVE SUBJECT MATTER
EXPERTS WHO ARE FOCUS KEENLY ON
THE REGULATORY AND REIMBURSEMENT
OR PAYMENT SIDE.
NOT ALWAYS REIMBURSEMENT.
THERE'S SOMEONE WHO HAS TO PAY
FOR YOUR TECHNOLOGY SINCE WE
DON'T MAKE THINGS FOR FREE AND
GIVE THEM AWAY.
IT COSTS MONEY.
THESE SUBJECT MATTER EXPERTS ARE
AVAILABLE FOR AD HOC
CONSULTATIONS AND MAY BE PART OF
THE DEVELOPING AND SOW DEPENDING
ON THE FOCUS OF THE SERVICE OR
VENDOR YOU'RE TRYING TO ENGAGE.
MANY OF THEM HAVE DECADES-LONG
HISTORIES WORKING WITH FDA,
WORKING WITH CMS, IN HEALTH CARE
SYSTEMS, AS NURSES, WORKING AS
PRODUCT DEVELOPMENT EXPERTS IN
LARGE COMPANIES.
AGAIN, EASIEST WAY TO REQUEST A
CONSULT, SEND AN E-MAIL.
WE'LL MAKE IT HAPPEN.
ONE OF THE WAYS TO TAKE THE
KNOWLEDGE, WE'VE TALKED TO YOU,
HELPED YOU UNDERSTAND, HOW ARE
YOU GOING TO GET THE MONEY?
YOU HAVE TO FIND A PARTNER,
POSSIBLY GIVE UP EQUITY,
POSSIBLY FIND A NEW
MANUFACTURER.
THERE ARE A LOT OF THINGS THAT
INNOVATORS NEED AS THEY GROW A
COMPANY.
A GREAT WAY TO GET THOSE IS TO
ATTEND SHOWCASE EVENTS AND TALK
TO PEOPLE.
SEED SENDS OVER 120 COMPANIES A
YEAR OUT TO TALK TO INVESTORS,
PARTNERS, DEVELOPERS,
CO-DEVELOPERS, YOU NAME IT.
WE DO THIS IN MANY DIFFERENT
PLACES, THE EVENTS WE ATTENDED
THIS YEAR THAT WE SIGNED
COMPANIES THIS YEAR ARE LISTED
ON THIS SLIDE.
IN ADVANCE OF EVERY EVENT THAT
WE'RE SENDING TEN OR MORE PEOPLE
TO, WHICH IS MOST OF THEM.
WE HOLD A WEBINAR AND WE TALK
THOSE INNOVATORS THAT WE'RE
SUPPORTING INTO THAT ROOM.
WE HELP THEM UNDERSTAND WHO THEY
ARE GOING TO MEET, HOW THEY
SHOULD APPROACH THAT MEETING,
HOW FAR IN ADVANCE THEY SHOULD
LOOK AT PARTNERING PORTAL,
IDENTIFYING PARTNERS,
DEVELOPERS, REACHING OUT AND
ENGAGING THEM.
WE THEN ASK THOSE COMPANIES TO
COME BACK TO US AND TELL US HOW
EFFECTIVE THEY WERE AT DOING
THAT.
WHO DID THEY MEET WITH?
IF I HAVE TEN OR MORE COMPANIES,
I HAVE AN EIR AT THAT EVENT SO
MY COMPANIES WITH TALK TO THAT
EIR, OH MY WORK, I TALKED TO
EDWARDS, THEY ASKED ME TO SET UP
A CALL.
I DON'T KNOW THE ANXIOUS.
THE EIR CAN TALK YOU TRUE AND WE
CAN HAVE A CONVERSATION THERE OR
SCHEDULE A CONSULT AND HELP YOU
WALK INTO THAT.
I TOLD YOU A BUNCH OF TIMES,
CONTACT ME.
THE ONLY THING I HAVEN'T HOLD
YOU IS HOW.
FIRST, THE SECRET CODES TO NIH,
FIRST TIME DOT LAST NAME DOT
NIH.GOV.
SUPER SECRET.
SEND MAN E-MAIL TO
SEEDINFO@NIH.GOV TO GET YOU TO
ANY AND ALL OF OUR PROGRAMS.
I THANK YOU SO MUCH FOR YOUR
TIME.
CHRIS SASIELA, INNOVATOR SUPPORT
TEAM DIRECTOR, SMALL BUSINESS
EDUCATION AND ENTREPRENEURIAL
DEVELOPMENT OFFICE.
[APPLAUSE]
>> I AM REBEKAH NEAL, PROGRAM
DIRECTOR AT VENTUREWELL, I'M
EXCITED TO SEE EVERYONE IN
PERSON.
I'VE BEEN WORKING IT'S ON RADx
PROGRAMS FOR THREE-ISH, THREE
AND A HALF YEARS.
IT'S BEEN REALLY DELIGHTFUL TO
SEE YOU IN PERSON.
I'M NOT GOING TO TALK ABOUT OUR
RADx WORK IN THIS TALK SO
PLEASE COME UP AFTERWARDS, HAPPY
TO SHARE MORE FOR THE LAST
ALMOST 30 YEARS NOW DEVELOPING
THAT INNOVATION AND
ENTREPRENEURSHIP ECOSYSTEM IN
THE U.S.
WE ARE A NON-PROFIT
HEADQUARTERED IN MASSACHUSETTS
SEEKING TO CULTIVATE THE
PIPELINE STARTING IN HIGHER ED,
GROWING THE ECOSYSTEM FOR
ACADEMIC INNOVATORS STUDENT
TEAMS MOVING INTO MORE VENTURE
DEVELOPMENT SUPPORT AND TRAINING
SOME TYPES OF THINGS BOB TALKED
ABOUT AND SAID YOU SHOULD LOOK
FOR AND HOW YOU MIGHT DO THAN.
WE MANAGE A SMALL INVESTMENT
FUND THAT SUPPORTS MANY
COMPANIES AND TEAMS AND THEN WE
DO THAT COMMERCIALIZATION WORK
ON MY TEAM.
WE DO THIS SUPPORT IN A VARIETY
OF WAYS AND ALWAYS THROUGH
PARTNERSHIPS.
I'LL TALK ABOUT HOW CRITICAL
PARTNERSHIP IS AS YOU ARE
DEVELOPING YOUR INNOVATION AND
COMPANY IF YOU'RE AN EARLY STAGE
INNOVATOR.
BOB AND OTHERS HAVE TALKED ABOUT
THAT ALREADY.
WE COULDN'T DO THE WORK WE DO
WITHOUT THESE PARTNERS.
REALLY TRYING TO HELP SUPPORT
THAT, THAT INNOVATION ECOSYSTEM
THROUGH NETWORK BUILDING, THE
NETWORK BOB MENTIONED THROUGH
WORKSHOPS AND TRAININGS, THE
I-CORPS PROGRAM.
REALLY GOING IN AND BUILDING
THAT NETWORK AND INFRASTRUCTURE
TRYING TO CONNECT THE DOTS AND
DOING THAT THROUGH THE SPACE OF
FUNDING OUR OWN -- HAVING OUR
ACCELERATOR FUNDING THE TEAMS
THAT COME OUT OF ACCELERATOR,
DOING COACHING AND MENTORING,
HAVING FOLKS LIKE BOB AND EIRs
THAT WE CAN CALL AND SAY, HEY,
WE NEED SOMEBODY WHO CAN DO THIS
FOR THIS TEAM FOR A LITTLE
WHILE, AND BRING THEM INTO
SUPPORT AS YOU'RE MOVING THROUGH
YOUR INNOVATION AND SUPPORT IN
IN VITRO AND MED TECH, FINDING
RESOURCES FURTHER DOWNSTREAM.
IF YOU WANT TO THINK ABOUT WHERE
DO YOU START, ONE OF THE MOST
CRITICAL THINGS AND WE START
WITH ALL THE TEAMS THAT COME
THROUGH THE WORKSHOPS IS BEING
HONEST AND CLEAR WHAT THE NEED
IS, WHERE YOU ARE AS AN
ORGANIZATION, WHERE YOUR IDEA
IS, YOUR COMPANY LOOKS LIKE, AND
WE'VE DEVELOPED THIS MENTOR
DEVELOPMENT FRAMEWORK ON THE
SLIDE, THERE ARE OTHER VERSIONS
SO THIS IS OUR VERSION BUT WOULD
ENCOURAGE YOU TO FINDS A VERSION
THAT WORKS FOR YOU.
THIS IS REALLY FOCUSED AROUND
SCIENCE AND TECHNOLOGY-BASED
COMPANIES LOOKING FOR EQUITY
OVER TIME.
SO THAT'S THE TRAJECTORY THAT
THIS IS LOOKING AT.
IT'S ACROSS SIX AXES, TEAM AND
VENTURE STRUCTURE, LOOKING AT
INNOVATION, TECHNOLOGY ITSELF,
IP AND STRATEGIES AND STRUCTURES
THAT UNDERLIE THAT, THE MARKET
AND WHAT THAT LOOKS LIKE.
THINKING ABOUT THE BUSINESS
MODEL AND RESOURCES.
WITH A WHAT WE SEE WITH STUDENT
SEEMS THINKING HARD ABOUT ONE OF
THESE THINGS, I KNOW WHAT MY
BUSINESS MODEL IS AND I'M GOING
TO DO THIS TO GET TO THE END.
AND IF YOU DO THAT, YOU GET TO
THE END OF THE BUSINESS MODEL
BUT HAVEN'T DONE ALL OF THE
OTHER PIECES TO GET TO A
SUCCESSFUL VENTURE AT THE END.
WE ENCOURAGE ANYONE IN OUR
PROGRAM TO THINK ABOUT ALL OF
THE DIFFERENCE AREAS THAT YOU
NEED TO BE FOCUSING ON AS YOU
MOVE KNOWING THEY ARE NOT ALL
GOING TO PROCEED SIMULTANEOUSLY
AT THE SAME PACE, SOMETIMES SOME
WILL GO FORWARDS, BACK, AND
OTHERS, BUT IT IS REALLY
CRITICAL TO LOOK ACROSS THOSE.
A QUICK EXAMPLE OF THE TEAM THAT
CAME IN TO ONE OF OUR
ACCELERATOR PROGRAMS.
WE MET THEM IN 2015, THE VENTURE
DEVELOPMENT FRAMEWORK WHEEL ON
THE LEFT.
AND SO WE HAD THEM REALLY LOOK.
WE DO THIS WITH THEM SO YOU'VE
HERDS ABOUT EXPERT ADVISORS,
IT'S IMPORTANT TO NOT DO THIS
ONLY YOURSELF.
YOU'RE OFTEN NOT HONEST ABOUT
WHERE YOU ARE AND WANT TO BE.
SO, HAVE THEM LOOK AT ALL THESE
THINGS.
THEY HAVE A STRONG SHOWING IN
THE 2015 ONE, FOR EXAMPLE, IN
TECH INNOVATION AND INTELLECTUAL
PROPERTY, HAD THEIR I.P.
PROTECTED IN A WAY MANY TEAMS DO
NOT.
THEY WERE COMING THROUGH OUR
PROGRAMS, THROUGH THE DIFFERENT
MENTORS, EXPERTS, NETWORKING
EVENTS THEY WERE ABLE TO
PARTICIPATE IN, WERE ABLE TO
MOVE EACH OF THESE THINGS
FORWARD TO THINK ABOUT, FOR
EXAMPLE, IN THEIR RESOURCE
STRUCTURE THEY HAD SCIENTIFIC
EXPERTISE, STRONG TECHNICAL TEAM
WITH SCIENCE ADVISORS, AS THEY
WENT TO BUILD OUT WHAT THIS
LOOKED LIKE AND HOW THEY WERE
GOING TO STRUCTURE THEIR VENTURE
OVER TIME, PARTICIPATING IN ALL
OF THESE, AND SOME OTHER
PROGRAMS THEY PARTICIPATED IN,
NETWORKING EVENTS, PULLED IN
SOME BUSINESS EXPERTISE THEY
WERE LOOKING FOR AND HOW THEY
TRIED TO GO FORWARD WITH
TECHNICAL EXPERTISE WOULDN'T
HAVE MADE THE PROGRESS IN ALL
THE AREAS YOU SEE.
BETWEEN 2015 AND 2019 MADE A
PIVOT IN CUSTOMER, TECHNOLOGY
APPLICATIONS, CHANGES BASED ON
ADVICE AND EXPERTISE AT THE
BEGINNING EVER -- OF THEIR WORK
WITH US.
I WOULD ENCOURAGE YOU TO SIT
DOWN, FIND WHAT WORKS FOR YOU,
MAYBE VENTURE DEVELOPMENT
FRAMEWORK, I HAD A LINK,
VENTUREWELL.ORG, AND THE GATES
SYSTEM THAT RADx HAS USED,
THINK THROUGH THE THINGS YOU
NEED TO MOVE FORWARDS.
I WON'T SPEND TIME ON FUNDING.
WE'VE HEARD ABOUT FUNDING FROM
OTHER FOLKS HERE.
ONE THING I DO WANT TO POINT OUT
FUNDERS DEPENDING ON WHERE YOU
ARE AS A VENTURE, AS AN
ORGANIZATION, WHAT YOU'RE
THINKING ABOUT, THINK ABOUT
MOTIVATION OF YOUR FUNDER AND
THINK ABOUT HOW THEY FIT INTO
YOUR PLAN AS A RESULT OF
MOTIVATION.
THERE ARE MISSION MOTIVATED
FUNDERS, THAT FIT IS CRITICAL.
THEY WANT TO SEE YOUR TECH MOVE
FORWARD.
THEY ARE FINANCIALLY MOTIVATED.
THAT'S A DIFFERENT CASE TO MAKE
TO A FINANCIALLY MOTIVATED
FUNDER THAN MISSION MOTIVATED
FUNDER.
A NUMBER OF OTHER FUNDING
VEHICLES THAT YOU CAN THINK
ABOUT.
THERE ARE DIFFERENT TYPES.
THIS IS SOMETHING YOU'RE AWARE
OF, TOUCHED ON IN EARLIER
PANELS.
I'M HAPPY TO MAKE THIS SLIDE
AVAILABLE, I WANT TO POINT OUT
AS YOU'RE THINKING ABOUT WHERE
YOU WANT TO GO AND GET THERE,
IT'S IMPORTANT TO THINK ABOUT
WHAT TYPE OF FUNDING WILL GET
YOU THERE AND WHERE YOU MIGHT
FIND THAT.
FOR EXAMPLE I USED TO WORK AT A
LARGE PHILANTHROPY, IF YOU COME
INTO A LARGE MISSION FOCUS WITH
AN IDEA NOT ON STRATEGY IT
DOESN'T MATTER, IT'S NOT A FIT.
THERE'S UNLIKELY TO BE OPERATION
SUPPORT FOR YOUR WORK IN THAT
WAY.
SOMETHING TO THINK ABOUT AS
YOU'RE MOVING FORWARD.
BOB PUT UP A GREAT LIST OF
DIFFERENT PLACES YOU CAN GO TO
LOOK FOR NETWORK SUPPORT AND
INFRASTRUCTURE, PARTICULARLY
REGIONALLY.
I WOULD ENCOURAGE YOU TO THINK
ABOUT ACCELERATOR PROGRAM,
SOMEPLACE THAT CAN KICK START
YOUR ACCESS TO ALL OF THOSE
NETWORKS THIS IS VENTUREWELL'S
ACCELERATOR PROGRAM, WE HAVE A
FAMILY OF PROGRAMS YOU CAN
ENTER, A LOT OF OTHER OPTIONS.
OUR TRAINING LOOKS LIKE I-CORPS,
AS BOB SAID A STANDARD PLAYBOOK.
THE ACCESS WILL BE PROVIDED TO
THAT ACCELERATORS NETWORK OVER
TIME.
DO THINK WHERE ARE YOU, WHAT
SORT OF ACCELERATOR IS A GOOD
FIT FOR YOU.
EVERYBODY WHO HAS TALKED ABOUT
SUPPORT SAND GROWING YOUR
VENTURE, BRINGING YOUR IDEA
FORWARD, BUILDING YOUR NETWORK,
I WANT TO POINT OUT A COUPLE
THINGS ABOUT ACADEMIC
ENTREPRENEURS, THAT'S THE BREAD
AND BUTTER, SUPPORTING HIGHER
EDS ECOSYSTEM AND STUDENT
INNOVATORS AND AS BOB NOTED,
MUCH BETTER RESOURCE FOR STUDENT
INNOVATORS, ACADEMIC INNOVATORS,
FIGURE OUT THE THINGS THEY OFFER
YOU, LOOK AT ON-CAMPUS
RESOURCES, ALSO LOOK AT YOUR
REGIONAL ENVIRONMENT AND THOSE
OFF-CAMPUS RESOURCES YOU MIGHT
FIND, TAKE THE OPPORTUNITIES TO
PARTICIPATE IN COMPETITIONS, AS
A OPPORTUNITY, EVEN AS ACADEMIC,
TAKE ADVANTAGE OF ALL THOSE
NETWORKING OPPORTUNITIES, THERE
ARE SO MANY NETWORKING
OPPORTUNITIES AND IN THE
ACADEMIC SETTING.
IN YOUR COMMUNITY THERE'S A
SIMILAR STRUCTURE, NOT ACADEMIC
BASED BUT A START-UP OPPORTUNITY
FOUND THROUGH YOUR SBA OR
SIMILAR AND THERE'S EVERY CITY
WILL HAVE THEIR OWN SET OF
INCUBATORS AND ACCELERATORS WITH
SPECIFIC FOCUS AREAS.
I'LL DO ONE OR TWO MORE SLIDES
AND I'M TOLD TO SPEED UP.
THINK ABOUT WHAT YOU AND YOUR
PARTNER MIGHT GET OUT OF THAT
GOING FORWARDS, SET EXPECTATIONS
IN EARLY, CLEAR ABOUT
PARTNERSHIPS, SET GOOD GOALS,
ALWAYS GO IN WITH EXIT PLAN IN
PLACE.
I WON'T GO OVER THIS PARTICULAR
EXAMPLE OF A PILOT STUDY BUT THE
KEY POINT IS THAT PARTICULAR
ORGANIZATION DIDN'T JUST GO WITH
THE FIRST ORGANIZATION THEY
FOUND TO BE A PILOT STUDY
PARTNER.
THEY THOUGHT THROUGH THE
STRUCTURE AND WHO WOULD BE THE
BEST FIT, LOOKED AT 20
ORGANIZATIONS, STARTED TALKING
TO FIVE, PICKED ONE.
IT WAS THE BEST LANDSCAPE, BEST
FIT.
YOU HERE -- HERE IS A LIST OF
RESOURCES WITH A COUPLE LINKS.
WE'VE COMPILED -- AS AN
ORGANIZATION WE FOCUS ON GROWING
THE FIELD AND LEARNING
OPPORTUNITIES.
YOU'LL FIND OPPORTUNITIES ON THE
RESOURCE PAGE, WE PARTNER WITH
COOLEY FOR FORMS AND LEGAL
ADVICE.
THEY HAVE A BIG SET OF START-UP
AND I.P. RESOURCES THAT YOU CAN
ALSO TAKE ADVANTAGE OF.
THAT'S IT.
THANK YOU.
[APPLAUSE]
>> AS THINGS ARE HAPPENING IN
THE BACKGROUND, I'M KARI
ASHMONT, TEAM LEAD FOR NIBIB,
OVERSEE SMALL BUSINESS PROGRAM
AND HELP WITH RADx ACTIVITIES.
MIKE MENTIONED I CO-LEAD THE
BRAIN INITIATIVE DISSEMINATION
TEAM.
THANK YOU FOR HAVING ME HERE
TODAY, MIKE.
THIS IS THE SMALL BUSINESS
PROGRAM, FOR THOSE WHO JOINED
THE WORKSHOP YESTERDAY, I
RECOGNIZE SOME FACES THIS SHOULD
SOUND FAMILIAR.
SO THE SMALL BUSINESS PROGRAM AT
NIH IS ONE OF OUR BIGGEST
RESOURCES, YOU THINK THE NIH,
FUNDING.
SO WE ARE THE LARGEST SOURCE OF
EARLY STAGE CAPITAL FOR
BIOMEDICAL OR LIFE SCIENCE
ENTREPRENEURS IN THE U.S.
THIS FUNDING IS NON-DILUTIVE,
YOU DON'T HAVE TO RETURN IT.
OFTEN USED AS LEVERAGE TO
ATTRACT MORE FUNDING FOR SMALL
BUSINESSES.
9 PROGRAM HAS TWO COMPONENTS,
SMALL BUSINESS INNOVATION
RESEARCH SBIR COMPONENT WHICH
PROVIDES $1.1 BILLION TO THE
SMALL BUSINESS COMMUNITY A YEAR.
AND THE SMALL BUSINESS
TECHNOLOGY TRANSFER PROGRAM,
WHICH HAS APPROXIMATELY $150
MILLION WORTH OF FUNDING PER
YEAR.
THERE'S DIFFERENT ENTRY POINTS
DEPENDING ON THE STAGE OF THE
PROJECT THAT YOU'RE WORKING ON.
YOU CAN COME FOR PHASE 1 AS
CHRIS MENTIONED TO ESTABLISH
FEASIBILITY PROOF OF CONCEPT
TYPE WORK.
YOU MIGHT HAVE BEEN ABLE TO
ACQUIRE FUNDING FROM A DIFFERENT
AGENCY AND MIGHT BE ABLE TO COME
FOR DIRECT TO PHASE 2 FOR FOLLOW
HAD BEEN ON ACTIVITIES TO
PROGRESS YOUR TECHNOLOGY DOWN
THE ROAD TOWARDS
COMMERCIALIZATION.
WE DO ALSO OFFER FAST TRACK
OPPORTUNITY WHICH COMBINES THE
PHASE 1 AND PHASE 2 INTO A
SINGLE APPLICATION AND LOWERS
THE AMOUNT OF TIME BETWEEN THE
PHASE 1 AND PHASE 2 AND FUNDING
ASSOCIATED WITH.
SBIR-ONLY FOR THE DIRECT TO
PHASE 2 OPTION IF YOU'RE COMING
IN FROM ANOTHER AGENCY.
IN ADDITION TO THESE STANDARD
PHASE 1 AND PHASE 2s WE HAVE A
PHASE 2B FOR SOME OF THE
INSTITUTES AND CENTERS AND
THAT'S AN IMPORTANT REOCCURRING
THEME AS I WALK THROUGH THIS,
NOT ALL INSTITUTES AND CENTERS
PARTICIPATE IN ALL ACTIVITIES.
PHASE 2B IS JUST AN ADDITIONAL
PHASE 2 TYPE ACTIVITY AND WE
HAVE COMMERCIALIZATION PILOT
PROGRAMS WHICH SUPPORT
COMMERCIALIZATION-RELATED
ACTIVITIES IN TERMS OF PUSHING
YOUR TECHNOLOGY OUT THE DOOR.
IN TERMS OF FUNDING
OPPORTUNITIES THE VAST MAJORITY
OF APPLICATIONS FOR SMALL
BUSINESS PROGRAM COME THROUGH
OUR FOUR OMNIBUS SOLICITATIONS,
CLINICAL TRIALS REQUIRED,
CLINICAL TRIALS NOT ALLOWED
VERSION FOR BOTH SBIR AND STTR
PROGRAMS.
IN ADDITION THERE ARE A NUMBER
OF SPECIALIZED MORE FOCUSED TO A
SPECIFIC AREA FUNDING
OPPORTUNITIES THAT EITHER
INDIVIDUAL INSTITUTES OR CENTERS
OR A GROUP OF INSTITUTES AND
CENTERS MIGHT PUT OUT.
I WOULD RECOMMEND REACHING OUT
TO THE INSTITUTE OR CENTER THAT
YOU'RE WORKING WITH, AND SEEING
WHAT OPPORTUNITIES THEY HAVE
AVAILABLE AND WHETHER OR NOT THE
OMNIBUS IS THE RIGHT APPROACH OR
THEY MIGHT HAVE A MORE SPECIFIED
VERSION THAT WOULD BE
APPROPRIATE.
IN THE ABSENCE OF TALKING WITH
ANYBODY THE SEED WEBSITE IS
EXCELLENT.
I DON'T THINK CHRIS PLUGGED IT
AS.
AS I'M GOING TO.
THE SEED WEBSITE IS A WEALTH OF
INFORMATION FOR ANYONE STARTING
A SMALL BILLS.
YOU CAN FIND A LINK TO THE
FUNDING OPPORTUNITIES ON THEIR
WEBSITE AS WELL.
NOW IN ADDITION TO FUNDING
OPPORTUNITIES OBVIOUSLY WE ALSO
HAVE OTHER RESOURCES.
AND THAT CAN STRETCH FROM SOME
OF THE RESOURCES THAT YOU HERDS
FROM CHRIS EARLIER TODAY OR WE
ALSO HAVE ONE AT NIBIB WHICH I
WILL HAPPILY TALK ABOUT IN MORE
DETAIL IN A MOMENT CALLED THE
CONCEPT, C3I PROGRAM, REACH OUT
TO PROGRAM OFFICERS, WE'RE
OURSELVES IN SOME WAYS A
RESOURCE TO YOU IN TERMS OF THE
HELPING DIRECT YOU TO
APPROPRIATE PROGRAMS, BEING
AWARE OF WHAT THE OPTIONS ARE
OUT THERE.
THIS SLIDE IS HERE SOLELY FOR
THE PURPOSE OF EMPHASIZING WHAT
I'VE ALREADY DONE, WHICH IS TO
SAY THERE ARE 27 INSTITUTES AND
CENTERS WITHIN THE NIH.
WE ALL HAVE OUR OWN FUNDING, OUR
OWN MISSIONS AND PRIORITY AREAS,
POLICIES, ET CETERA, AND THAT
APPLIES TO SMALL BUSINESS
PROGRAMS THAT RUN WITHIN THESE
INSTITUTES AND CENTERS AS WELL.
SO IT'S IMPORTANT TO REALIZE
THAT WHEN YOU KNOW ONE INSTITUTE
OR CENTER AT THE NIH, YOU KNOW
ONE INSTITUTE OR CENTER AT THE
NIH.
SO YOU REALLY NEED TO TALK WITH
PEOPLED SAND MAKE SURE THAT YOU
HADS ARE UNDERSTANDING HOW THEY
ASSESS APPLICATIONS, PRIORITY
AREAS, SO YOU'RE SETTING
YOURSELVES UP FOR SUCCESS AT
THAT PEER REVIEW PANEL BUT ALSO
ADMINISTRATIVE REVIEW LEVEL
POST-REVIEW PANEL.
SO WE'RE UNIQUE IN TERMS OF
INSURE TIGHTS AND --
INSTITUTES AND CENTERS, DISEASE
AGNOSTIC FOCUS ON TOOL
TECHNOLOGY AND ENGINEERS WITH A
WIDE VARIETY WE SUPPORT.
I WON'T GO THROUGH THE LIST ON
THE SLIDE BUT GENERALLY SPEAKING
IF YOU ARE APPLYING FOR FUNDING
THAT IS FOCUSING ON TECHNOLOGY
DEVELOPMENT, PRODUCTLY
APPLICABLE AND ULTIMATELY GEARED
TO IMPROVING HUMAN HEALTH
THERE'S A CHANCE YOU WOULD FIT
WITHIN OUR MISSION.
BUT OF COURSE WITH SUCH A BROAD
MISSION, THERE'S A LOT OF GRAY
AREAS, SO AGAIN THE KEY MESSAGE
HERE IS REACH OUT, SEND A
DRAFT-SPECIFIC AIMS PAGE AND WE
CAN GO FROM THERE IN TERMS OF
HELPING YOU TO DIRECTS YOU TO
THE RIGHT PLACE.
NIBIB IS SMALL BUT MIGHTY.
WE HAVE ABOUT $13.2 MILLION IN
OUR SMALL BUSINESS ANNUAL BUDGET
WITH ABOUT 46 ACTIVE AWARDS.
YOU CAN SEE WE SUPPORT A WIDE
VARIETY OF TECHNOLOGY
DEVELOPMENT AREAS.
AND IN ADDITION TO SOME OF THE
FUNDING OPPORTUNITIES THAT OTHER
INSTITUTES HAVE WE'RE
PARTICIPANTS IN THE BRAIN
INITIATIVE AND HEAL INITIATIVE.
AS PROMISED, ONE NON-FUNDING
RESOURCE NIBIB HAS THAT WE'RE
PROUD OF IS CALLED THE C3I
PROGRAM, IS A PROGRAM THAT IS
BASED ON THE COMMERCIALIZATION
PROCESS AND IS REALLY GEARED TO
EDUCATING AND MENTORING
INNOVATORS HOW TO TRANSLATE
THEIR IDEAS FROM CONCEPT IN THE
LAB OUT TO COMMERCIALIZATION.
THE PROGRAM ITSELF HAS THREE
COMPONENTS, AND FOR EACH OF THEM
YOU ARE PAIRED WITH A BUSINESS
ADVISER AS WELL AS PROJECT
MANAGER WHO HAS EXPERTISE IN
YOUR FIELD TO HELP TO GUIDE YOU
ALONG THIS PROCESS.
THE FIRST COMPONENT IS THE EC
3I, THIS IS FOCUSED ON
EDUCATION, SPECIFICALLY RUN
DURING THE SUMMERTIME.
THIS IS BECAUSE THIS PROGRAM IS
TARGETING ACADEMIC INNOVATORS
WHO ARE JUST GETTING STARTED AND
TRYING TO FIGURE OUT IF THEIR
IDEA, IF THEIR INNOVATION
ACTUALLY HAS SOME LEGS.
SO THE PROGRAM IS LARGELY
FOCUSED ON UNDERSTANDING THE
MARKET, AND WHAT YOUR VALUE
PROPOSITION MIGHT BE.
WE CONSIDER A VERY GOOD OUTCOME
TO BE THAT YOU MIGHT REALIZE
WHAT YOU THOUGHT WAS THE BEST
MARKET ISN'T, AND YOU MIGHT NEED
TO PIVOT TO A DIFFERENT ONE.
THAT'S INDEED A SUCCESS BECAUSE
YOU'VE DONE THAT EARLY ON IN THE
PROCESS.
YOU CAN SEE ON THE BOTTOM THAT
WE ARE NOT THE ONLY PARTICIPANTS
IN THIS PROGRAM SO WE DO
ACTUALLY OPEN UP ALL OF C3I TO
DIFFERENT INSTITUTES AND CENTERS
ACROSS THE NIH SO DEPENDING WHOM
YOU'RE WORKING WITH YOU MAY BE
ABLE TO APPLY TO THE C3I PROGRAM
IF YOU'RE NOT AN AWARDEE
DIRECTLY.
THE SECOND PART IS NAMED THE C3
#EURBGS PROGRAM FOCUSED ON
VALIDATION AND EXECUTION, GEARED
TOWARDS EARLY STAGE SMALL
BUSINESSES, OR INNOVATORS WHO
MAY HAVE DONE THIS EC3I PROGRAM,
A MUCH MORE INTENSIVE 24-WEEK
PROGRAM THAT HAS AN IN-PERSON
BOOT CAMP MIDWAY THROUGH AND IS
FOCUSED TO EVALUATING THAT UNMET
MARKET KNEELED DOING ADDITIONAL
NEEDS ASSESSMENTS, UNDERSTANDING
YOUR REGULATORY AND
REIMBURSEMENT PATH AND HOPEFULLY
IDENTIFYING THE KILTER
EXPERIMENT TO PUSH YOUR
TECHNOLOGY THOSE NEXT STEPS
CLOSERS TOWARDS
COMMERCIALIZATION.
ULTIMATELY, THIS PROGRAM WILL
HELP TO PUT TOGETHER A SORT OF
FIRST DRAFT OF A PITCH TO
HOPEFULLY LINE YOU UP TO GO OUT
AND TALK TO OUTSIDE INVESTORS
AFTERWARDS.
AND THEN THE LAST COMPONENT IS
ONE THAT -- SORRY, I'VE GOT
OVERLAP.
NIBIB IS THE ONLY PARTICIPANT IN
THIS ONE, AND THIS IS A
SUPPLEMENT PROGRAM SO THIS IS
SPECIFICALLY FOR ACADEMIC
INNOVATORS WHO HAVE A RESEARCH
PROBLEM GRANT R01-TYPE PROPOSAL,
ALREADY HAVE BEEN THROUGH 3CI,
THE GOAL TO HELP TO CONTINUE ON
THE MOMENTUM THAT WAS BUILT
DURING C3I AND TO EXECUTE THOSE
EXPERIMENTS THAT YOU IDENTIFIED,
CONTINUE ON THE
COMMERCIALIZATION PATH IN TERMS
OF BUILDING STRATEGIC
PARTNERSHIPS, ALLOW YOU TO PUT
TOGETHER A COMPELLING SMALL
BUSINESS APPLICATION TO COME IN
AND MAKE THAT TRANSITION INTO
ENTREPRENEURSHIP.
SO, I THINK WITH THAT AND TIME
IN MIND I'M GOING TO LEAVE IT
THERE.
THE BIGGEST TAKEHOME MESSAGE IS
PLEASE REACH OUT, HAVE
CONVERSATIONS IN TERMS OF
UNDERSTANDING WHAT RESOURCES
FINANCIAL AND OTHERWISE ARE
AVAILABLE.
PART OF OUR JOB IS TO HELP, SO
THANK YOU.
[APPLAUSE]
>> THIS IS A BRIEF SUMMARY.
TALK WITH SOMEONE.
YOU CAN FIND A LOT OF MATERIAL
ONLINE, READ STUFF, TAKE ONLINE
COURSES, YOU NEED TO TALK WITH
SOMEBODY TO HELP THEM FIGURE OUT
HOW TO HELP YOU NAVIGATE.
WE HAVE TIME FOR MAYBE ONE OR
TWO QUICK QUESTIONS.
IF NOT I'LL ASK QUESTIONS.
YES, MICHAEL?
>> I WORK WITH THE RADx
PROGRAM.
A QUESTION THAT MIGHT BE HELPFUL
TO THE AUDIENCE.
CAN YOU EXPLAIN THE DIFFERENCE
BETWEEN A GRANT AND A CONTRACT?
>> YES.
A GRANT YOU PROPOSE,
INVESTIGATOR INITIATED, YOUR
IDEA, PEER REVIEWED, AND IF IT'S
MERITORIOUS BASED ON PEER REVIEW
AND LEADERSHIP, INTERNAL
DISCUSSIONS, YOU GET FUNDED, YOU
GET THE MONEY, WE EXPECT GOOD
THINGS AND MAKE SURE YOU'RE
COMPLYING WITH FEDERAL POLICIES.
A CONTRACT, WE WANT YOU TO DO
SOMETHING.
WE SOLICIT SOMEBODY TO SOLVE
THIS PARTICULAR PROBLEM WHETHER
RESEARCH OBJECTIVE OR A PROCESS
OBJECTIVE.
YOU PROPOSE, WE REVIEW IN
COMPARISON WITH OTHER PROPOSALS
AND PICK THIS ONE, DO THIS, MEET
MILESTONES, YOU GET PAID.
THAT'S THE SHORT VERSION.
>> I'LL ADD THAT THE TEAMS THAT
COME THROUGH I-CORPS IF THEY
HAVE A GRANT YOU ASK WHO THE
CUSTOMERS CLINICIANS, USERS, END
USERS.
IF THEY HAVE A CONTRACT THEY SAY
IT'S NIH.
>> IF SOMEBODY IS RECIPIENT OF
AWARD THROUGH A NETWORK OR HUB
LIKE POCTRN, MED TECH, ARE THEY
ELIGIBLE FOR TABA SANDALED NCB
3I.
>> THROUGH SEED OFFICE, YES.
REQUIREMENT IS ONE NIH, COULD
HAVE BEEN A PRIZE COMPETITION,
NETWORK, WHATEVER.
>> AND SAME FOR THE C3I PROGRAM.
WE RUN THROUGH A CONTRACT,
COLLABORATION WITH LAB TO
MARKET, CAN BE FLEXIBLE WITH HOW
WE ALLOW PARTICIPANTS TO APPLY,
YEAH.
>> GREAT.
QUICK QUESTION FOR REBEKAH.
THERE'S FOR-PROFIT ACCELERATORS
VERSUS NON-PROFIT, TALK ABOUT
THE DIFFERENCE IN WHAT THE
COMPANY GETS OUT OF IT?
>> I MAY ASK BOB TO SPEAK IF YOU
LIKE.
FROM MY PERSPECTIVE, THE
CURRICULUM IS LIKELY TO BE
REALLY SIMILAR BETWEEN --
REGARDLESS OF ACCELERATOR, THE
SAME PLAYBOOK, ACCESS MAY BE
DIFFERENT, CONTROL, THE EQUITY,
THE PIECE ACCELERATOR TAKES IS
DIFFERENT.
YOU MAY LOSE SOME OF YOUR
ABILITY TO DIRECT HOW YOU COME
OUT OF THAT ACCELERATOR AND WHAT
YOUR ORGANIZATION OR WHAT YOUR
PRODUCT OR WHO YOUR CUSTOMER IS
AS YOU GO THROUGH.
BOB, WOULD YOU WANT TO ADD?
>> I THINK YOU SAID IT RIGHT.
THERE'S A VERY BROAD AWARE OF
TYPES OF ACCELERATORS AND
INCUBATORS, DO YOUR RESEARCH.
THE MENTORSHIP NETWORK IS
IMPORTANT TO UNDERSTAND HOW THEY
FIT.
>> WE HAVE A BREAK NEXT FOR 15
MINUTES.
SO DON'T BE LATE.
AND IF YOU SEE US AND HAVE
QUESTIONS, ASK US, YOU HAVE OUR
CONTACT INFO IN THE BROCHURE.
LOOK ONLINE, TALK WITH SOMEBODY. THANKS.
WE'RE GOING TO GET STARTED
AGAIN.
I HOPE YOU ALL HAD A GREAT
BREAK.
THIS SESSION STANDS IN BETWEEN
RAPID PITCH AND E-POSTER EXHIBIT
SESSIONS BUT YOU HAVE A TREAT
TODAY BECAUSE NOW WE'LL GO
THROUGH THE PRESENTATIONS,
RESOURCES, CAPABILITIES,
QUESTION-AND-ANSWER FOR THE
POCTRN CENTERS, WE'RE EXCITED TO
HAVE THE SIX CENTERS HERE TO
TALK ABOUT THEIR CENTERS, AND I
HAVE MY COLLEAGUE JUE CHEN FROM
NHLBI HOSTING THIS SESSION HERE.
>> I'M JUE CHEN, PROGRAM OFFICER
AT THE NATIONAL HEART, LUNG AND
BLOOD INSTITUTE.
AND I ALSO SERVE AS SCIENCE
OFFICER FOR POCTRN NETWORK.
IT'S MY PLAID TO MODERATE TODAY.
WE'LL HEAR SIX PRESENTATIONS
FROM THE SIX POCTRN CENTERS AND
AFTER THAT HAVE A Q&A SESSION.
SO OUR FIRST SPEAKER IS DR. GREG
MARTIN, DIRECTOR OF PREDICTIVE
HEALTH INSTITUTE AND CENTER FOR
HEALTH DISCOVERY AND WELL-BEING.
AND PROFESSOR OF MEDICINE AT
EMORY SCHOOL OF MEDICINE.
HE WILL TALK ABOUT THE ATLANTIC
CENTER FOR MICROSYSTEMS
ENGINEERED POINT OF CARE
TECHNOLOGIES.
>> S MY -- IT IS MY PLEASURE TO
PRESENT FOR THE TEAM.
WILBUR LAMB WAS GOING TO BE
PRESENTING SO I WILL STEP IN FOR
HIM.
THANK YOU FOR THE INTRODUCTION.
WHAT OUR MISSION IS, OUR GOAL IS
DIFFERENCE THAN OTHER NETWORK
SITES IN THE SENSE WE FOCUS ON
ENABLING THE TRANSLATION AND
ACCELERATION OF TECHNOLOGIES,
PARTICULARLY IN THE MICROSYSTEMS
POINT OF CARE BASED, CONDUCTING
CLINICAL EVALUATION TECHNOLOGY,
ADDING VALUE IN OTHER AREAS,
PARTICULARLY REGULATORY
USABILITY AND OTHER ASPECTS.
IF YOU WANT MORE INFORMATION
CLEARLY OUR WEBSITE IS THERE.
IT'S HELPFUL.
THE OTHER PART I WILL TOUCH ON
SO YOU'RE ALL AWARE, WILBUR LAMB
IS OUR LEAD P.I., MYSELF AS
CO-P.I., AND ERIC VOGEL, THIRD.
WE SPAN THREE SYSTEMS, WE CROSS
FROM OUR EMORY UNIVERSITY SYSTEM
INTO CHILDREN'S HEALTH CARE
SYSTEM AND GEORGIA TECH WITH
ERIC.
MANY MANY REMEMBER OLIVER BRAND,
ENGINEERING P.I., INSTITUTE FOR
ELECTRONICS AND NANOTECHNOLOGY,
SADLY HE PASSED AWAY
UNEXPECTEDLY EARLIER THIS YEAR.
ERIC HAS STEPPED IN, LEADS P.I.
I WANT TO COVER STRUCTURE AND
CAPABILITIES, QUICKLY COVERING
THE CORES WHICH YOU WOULD EXPECT
IN ANY POCTRN SITES, THE MAIN
THINGS TO HELP YOU SEE OUR FOCUS
ON IS CONNECTION INSIDE AND
OUTSIDE TO THE FLOW ACROSS OUR
TECHNOLOGY CORE, CLINICAL CORE
AND DISSEMINATION CORE.
IT TALKS ABOUT THE DIFFERENT
CAPABILITIES, I'LL FOCUS ON THE
NEXT COUPLE SLIDES AND
ADMINISTRATIVE CORE CONNECTING
TO THE OTHER SITES AND
COORDINATE NATION.
ALL OF THOSE PIECEES SOME
TOGETHER, ADMINISTRATIVE CORE
WORKING WITH EXTERNAL ADVISORS
AND EVERYTHING IN GRANTS
MANAGEMENT.
THE MAIN THINGS IN TERMS OF
RESOURCES, EXPANDED AND CHANGED
OVER THE LAST FEW YEARS AS WE'VE
GROWN IN OUR CENTER, HELPED
RESPOND IN THE PANDEMIC, WORKED
IN RADx, ADDING SPECIFIC
AREAS.
USABILITY, ACCESSIBILITY, HUMAN
FACTORS WITH HOME LAB TEAM AT
GEORGIA TECH WHICH IS FANTASTIC
HAS CREATED SCALE AND ASSESSMENT
TOOLS AND NOT JUST FOR
INDIVIDUAL DEVICES BUT ALSO HOME
LAB MIGHT IMPLY THERE'S A GROUP
OF PEOPLE WHO ARE WHAT I CALL
FREE RANGE HUMANS, MEANING
AVERAGE PEOPLE WHO ARE MORE THAN
CAPABLE OF PARTICIPATING AND
WILLING TO PARTICIPATE IN
STUDIES SO THEY CAN HELP PROVIDE
GUIDANCE AND
QUANTITATIVE/QUALITATIVE
ASSESSMENT.
WE HAVE THE USABILITY TEAM.
A NATIONAL EXPERT ON OUR TEAM
HAS A REGULATORY TEAM AND
SKILLED IN PROVIDING
CONSULTATION AND PLANNING FOR
TEAMS AND TECHNOLOGIES.
WE DO TRL ASSESSMENT, DEVICE
DESIGN FABRICATION MATERIALS,
CHARACTERIZATION, IN ENGINEERING
CORE AND TECHNOLOGY ASSESSMENT
AND LOOKING AT WAYS TO THINK
ABOUT IMPROVING OR CHANGING
DESIGN TO HELP DEVICES AS
BROUGHT TO US TO ACCELERATE
DEVELOPMENT.
THE CLINICAL CORE PIECE,
ASSESSMENT AND VALIDATION IN
TERMS OF IMPLEMENTATION AND
DISSEMINATION, EDUCATION, ALSO
CLINICAL AND LABORATORY
ASSESSMENT, ANOTHER PIECE WE'VE
GROWN.
THE LAST THING IS SPECIFIC
SERVICES, THINGS WE'VE EXPANDED,
MICROMACHINING, 3D PRINTING, WE
DO THAT ON A COUPLE CAMPUSES, WE
HAVE THE ABILITY TO DO
MICROMACHINING INTERNAL IN OUR
HOSPITAL UNIVERSITY SYSTEMS ALSO
WITHIN ACME, AND THEN EXTENDED
REALITY MULTI-SPACE, COMES WITH
THE BUILDING ENVIRONMENT AND
SOME OTHER PROGRAMS WE'RE
BUILDING, AND THAT'S LINKED TO
OUR UNIVERSITIES AS WELL.
AND FINALLY I'LL TOUCH ON THINGS
WE SHARE INSIDE AND OUTSIDE THE
NETWORK.
I'VE TOUCHED ON SOME THINGS LIKE
SHARING CLINICAL SAMPLES ARE A
LARGE DATABASE, ANALYTICAL AND
CLINICAL TESTING, HOME LAB FOR
USABILITY AND HUMAN FACTORS,
DEEP MUTATIONAL SCANNING, A
REALLY IMPORTANT TOOL DURING THE
COVID PANDEMIC FOR TRYING TO
UNDERSTAND VARIANTS ACROSS THE
COVID STRAINS.
AND OPPORTUNITIES FOR
COLLABORATION, PARTICULARLY IN
THE FIELD OF MICROFLUIDICS AND
MICROSYSTEMS, ANYTHING THAT
FALSE IN OUR CLINICAL REGULATORY
USABILITY AND ENGINEERING
DOMAINS.
I WILL STOP AND HAND BACK TO JUE
FOR THE NEXT INTRODUCTION.
>> DR. DAVE MCMANUS ON
DEPARTMENT OF MEDICINE,
UNIVERSITY OF MASSACHUSETTS,
CHAN MEDICAL SCHOOL, EDITOR IN
CHIEF OF CARDIOVASCULAR DIGITAL
HEALTH JOURNAL SHARING RESOURCES
AND CAPABILITIES OF THE CENTER
FOR ADVANCING POINT OF CARE IN
HEART LUNG BLOOD AND SLEEP
DISEASES.
>> THANK YOU FOR THE OPPORTUNITY
TO PRESENT ALONGSIDE THE SISTER
POCTRNs.
AS YOU CAN SEE, ONE OF THE
DISTINGUISHED CHARACTERISTICS IS
IT IS BORN FROM A MEDICAL DEVICE
INCUBATOR, EACH CENTER HAS
SLIGHTLY DIFFERENT HISTORY, THAT
INFORMS RESOURCES WE PROVIDE SO
I'M GOING TO COME BACK IN A
MOMENT.
SO WE'RE FUNDED THROUGH
PRIMARILY NATIONAL HEART LUNG
BLOOD INSTITUTE AS WELL AS
NATIONAL CENTER FOR
COMPLEMENTARY AND INTEGRATIVE
HEALTH.
OUR FOCUS ON DEVELOPMENT AND
POINT OF CARE, OUR TEAM IS
COMPRISED OF PEOPLE, THREE
P.I.s, AN ENGINEERING P.I.,
CLINICAL P.I., BRIAN BUCHHOLZ
HAS BEEN WITH THE PROJECT FOR
MANY YEARS, AND DR. NATE HAFER
HAS BEEN PUT INTO THE MULTI-P.I.
ROLE IN THIS RENEWAL.
YOU CAN SEE A NUMBER OF KEY
STAKEHOLDERS BUT IF YOU REMEMBER
NOTHING ELSE FROM MY
PRESENTATION IT'S THE NAME OF
MARION PICCARD, AN EXCELLENT
POINT-OF-CARE CONTACT FOR US
ADVISER AND SHE'S EXTREMELY
PLUGGED INTO THE NETWORK OF MED
DEVICE INNOVATORS AND INCUBATOR
ACROSS THE EAST COAST.
A NUMBER OF INDIVIDUALS COMPRISE
OUR TEAM.
AS A MORE LATER STAGE TECHNOLOGY
FOCUSEDDER, WE FOCUS ON CLINICAL
AND VALIDATION STUDIES, ADDED A
PHENOCAPABILITY, BRINGING IN A
PSYCHOLOGIST TO THINK ABOUT
APPLICATIONS IN VULNERABLE
POPULATIONS, PRESENTATION ABOUT
MATERNAL HEALTH ARE SEVERAL
CARDIOVASCULAR DEVICES AND I'M
THINKING THERE MAY BE SOME
CROSS-POLLINATION WITH OUR
CENTER AS WE LEAVE HERE IN
INVOLVEMENT OF HER.
THE OTHER PERSON I WANT TO
HIGHLIGHT BROUGHT TREMENDOUS
CAPABILITY IN SIGHT LIST AND
POINT OF CARE CLINICAL TRIALS.
HIS WORK WAS CITED BY DR. BILL
HEEDRICKS, HE AND NEW MEMBERS
BRING EXCELLENT CAPABILITIES
THAT WOULD ALLOW US TO GO
FURTHER WITH HOME-BASED
SIGHTLESS TRIALS.
AGAIN, WE HAVE BROUGHT TAKE IN
THE CONTEXT OF CAPCAT TWO
UMass CAMPUSES, , LOCAL AND
WORCESTER, TO GET INCUBATOR
SPACE, WE PROVIDE ACCESS TO
TRAINING, I-CORPS TRAINING
MENTIONED EARLIER, AS WELL AS
ACCESS TO BIOSAMPLES AND SIMILAR
RESOURCES OTHER CENTERS OFFER.
IN ADDITION PARTICULAR FOCUS ON
CLINICAL RESEARCH DESIGN
METHODOLOGY, STATISTICAL
ANALYSIS, USER-CENTERED DESIGN
AND TRIALS ARE UNIQUE FEATURES I
THINK.
SO, ONE OF THE OTHER THINGS WE
DO DIFFERENCELY IN THE CONTEXT
OF OUR CENTER, WE ISSUE SURVEYS
PREVIOUSLY MENTIONED AS PARTS OF
OUR NEEDS ASSESSMENT THAT'S DONE
YEARLY BEFORE WE GO LIVE WITH
CALL FOR APPLICATIONS TO INFORM
WHAT WE ASK FOR IN TERMS OF OUR
CALL, INCORPORATING CLINICIAN
VOICES AS WELL AS PATIENT VOICES
INTO THIS AND IT'S BEEN HELPFUL
TO SEE INCREASED INTEREST IN
THIS AREA AMONG BOTH GROUPS.
THESE ARE A FEW OF THE
EDUCATIONAL OPPORTUNITIES, IS A
12-WEEK ACCELERATOR PROGRAM AND
A CORE THAT DR. DUNLAP RUNS,
INCLUDES A NUMBER OF STUDENTS
AND POTENTIAL INTERNS IN
START-UP COMPANIES.
AND ONE OF THE OTHER THINGS WE
DO WHICH WE STARTED TWO YEARS
AGO WHICH HAS BEEN SUCCESSFUL IS
THE SHOWCASE EVENT THAT HAS
REALLY BECOME A CENTERPIECE FOR
OUR YEAR.
SO WE TYPICALLY FUND FOUR OR
FIVE AWARDEES, WE'VE HAD A TOTAL
OF 23.
THEY GO THROUGH PITCH COACHING
FROM STEVE FLAME, SHOWN EARLIER
BY DR. SESETTI AND OTHER
ENTREPRENEURS IN RESIDENCE AT
NIH OVER THE COURSE OF THE YEAR,
GRADUATION EVENTS THE AWARDEES
COME IN FRONT OF A PANEL
COMPRISED OF VENTURES, STRATEGIC
INVESTORS, OTHERS FROM JOHNSON &
JOHNSON, SIEMENS AND OTHER
PLAYERS IN THE BIOTECH SPACES
LEADING TO INVESTMENTS IN AT
LEAST TWO CASES, A GREAT
OPPORTUNITY FOR NETWORKING AND
THINKING ABOUT THAT NEXT PHASE
OF COMMERCIALIZATION.
THIS IS SOMETHING WE PLAN TO DO
AGAIN AND HOPE TO ENGAGE A
NUMBER OF YOU IN THE EXPERIENCE.
SO TO SUMMARIZE THESE ARE
RESOURCES WE SHARE.
WE'VE SHARED WITH DR. MANABI
SOME INTERACTIVITY, AND OVER THE
COURSE OF THE YEAR USE A
STRUCTURED INTERVIEW MONTHLY
WITH A TEMPLATE AS WELL AS OTHER
RESOURCES LISTED HERE.
WE'D LOVE TO WORK WITH YOU MORE
AND APPRECIATE THE OPPORTUNITY
TO SPEAK WITH YOU TODAY.
THANK YOU.
>> NEXT IS DR. MANAPI LEADING
THE LONGEST STANDING POCTRN
CENTER AT INCOMES, ASSOCIATE
DIRECTOR OF GLOBAL HEALTH
RESEARCH AND INNOVATION
PROFESSOR OF MEDICINE.
THANK YOU.
>> THANKS, DR. CHEN.
IT'S NICE TO TALK ABOUT OUR
CENTER.
FOR THOSE THAT KNOW, THE CENTER
WAS FOUNDED BY CHARLOTTE GATOS
IN 2007.
WE HAVE THE HONOR OF BEING PART
OF THIS INCREDIBLE NETWORK FOR
THE LONGEST PERIOD OF TIME, ALSO
HAVING LIVED THROUGH A TIME
POINT-OF-CARE WASN'T A TIME TO
-- WASN'T A THING TO WHERE IT IS
A THING.
WE'VE EXPANDED BEYOND STDs TO
THINK ABOUT INFECTIOUS DISEASE.
MY OWN OPINION IS WE'RE AT A
MOMENT IN TIME, ALL THESE
PLATFORMS THAT HAVE THE EXACT
USE CASE AND DISEASE FOR WHICH
IT COULD BE MODIFIED.
I THINK THAT'S WHERE OUR EFFORTS
ARE GOING TO GO IN THIS CYCLE.
SO, THE CHALLENGE HALF THE
WORLD'S POPULATION DOESN'T HAVE
ACCESS TO DIAGNOSTICS.
OUR MISSION IS TO PROMOTE
DISEASE DIAGNOSTICS.
WE TAKE A LOT OF EARLY STAGE,
MID-STAGE, EVEN MATURE
TECHNOLOGIES.
THESE ARE THE CORE LEADS.
CORES, CLINICAL CORE,
TECHNOLOGY, DISSEMINATION CORE.
I HAVE HERE MOST IMPORTANT FOR
ALL OF YOU STEPHANIE WILL BE
SITTING AT OUR TABLE, OUR
COMPANY-FACING LIAISON.
YOU CAN GET TO HER THROUGH THIS
PARTICULAR E-MAIL.
SO WE HAVE DEVELOPED THIS WAY
BECAUSE CLINICAL CORE DEVELOPED
BIOREPOSITORY.
THERE ARE SOME COMPANIES IN THIS
AUDIENCE THAT BENEFITED FROM
THAT.
IF YOU HAVE A CHANCE TO AT LEAST
TRY OUT YOUR TECHNOLOGY IN
MATRIX, YOU CAN DO BETTER,
CLINICAL CAR, AWE HOW A
DIAGNOSTIC CAN BE USED, IMPACT
STUDY IN SETTINGS, WHETHER IN
CINCINNATI IN ADOLESCENCE,
UGANDA IN RESOURCE LIMITED
SETTINGS OR EMERGENCY ROOM AT
HOPKINS, OR STI CLINICIAN.
THE CORE IS DOING NEEDS
ASSESSMENTS, IN THE BEGINNING
NOBODY KNEW WHAT POINT OF CARE
WAS.
WHAT DO YOU MEAN, A GRAM STAIN?
WHICH IS A POINT OF CARE TEST
BUT NOT WHAT WE WERE
INTERESTING, INTERESTING TO SEE
HOW THINGS EVOLVED.
TRANSITIONING FROM APPLIED
PHYSICS TO US NOW.
WE RUN WEEKLY MEETINGS WITH
COMPANIES SO EVERY MONDAY I MEET
WITH A COMPANY PROBABLY 40 TIMES
A YEAR SO WE'RE HAPPY TO MEET
WITH ANYBODY THAT WANTS TO TALK
ABOUT STIS, OR OTHER INFECTIOUS
DISEASE TARGETS THAT THEY MIGHT
BE THINKING ABOUT WITH THEIR
PLATFORM.
WE RUN THE YEARLY SOLICITATION
THROUGH CIMIT AND THE NETWORK.
THIS IS ANOTHER WAY TO REPRESENT
THINGS WE DO.
WE HAVE A MASSIVE ONLINE FREE
COURSE.
WE'VE REALIZED A LOT OF PEOPLE
DON'T KNOW ENOUGH ABOUT
GONORRHEA, CHLAMYDIA, SYPHILIS,
HIV-INFECTED AND SO FORTH.
YOU CAN TAKE THIS AT YOUR
LEISURE AND LEARN ABOUT THE
BASIC ISSUES ENCOUNTERED IN THE
CLINICAL CONUNDRUMS PART OF STI
CLINICAL PRACTICE.
WE THOUGHT ABOUT VALUE-BASED
ADOPTION WHERE YOU DON'T
GULLS -- YOU CAN MAKE A GREAT
DIAGNOSTIC BUT YOU MAY FIND
AFTER YOU CREATED IT THERE'S NO
ONE TO ADOPT AND HAVE YOU NO
COMMERCIAL MARKET SO WE'VE
THOUGHT ABOUT THAT SPACE AS
WELL.
WE DO SELF-ASSESSMENT SYSTEMS
ENGINEERING.
IF YOU TAKE THIS ONLINE MODULE
YOU CAN GET SHUNTED DOWN
PATHWAYS DEPENDING ON ANSWERS TO
QUESTIONS AND WE CAN LINK WITH
SUBJECT MATTER EXPERTS TO HELP
YOU IN THINKING MORE
HOLISTICALLY ABOUT YOUR DEVICE.
WE HAVE BIOREPOSITORIES, AND
MANY WHO ARE PART OF RADx HAVE
SEEN THAT.
WE'VE DONE 92, A SIMILAR NUMBER
IN STIS.
DESKTOP EVALUATIONS IS SOMETHING
WE STARTED DURING COVID.
THIS HAS BEEN A GREAT WAY FOR US
TO, WITH PEOPLE WITH
COLLECTIVELY ABOUT 80 YEARS OF
POINT OFCARE DEVICE EXPERIENCE
TO HAVE THEM TRY OUT YOUR DEVICE
AND TELL WHAT YOU THEY THINK,
THEY FIND DIFFICULT TO
UNDERSTAND ABOUT USE OF YOUR
DEVICE.
AND TESTING IN CONTEXT TO THINK
ABOUT IMPACTFUL USE.
WE HAVE RESEARCH INCUBATORS IN
THE EMERGENCY ROOM AT HOPKINS,
IN SINCE GREAT WHERE YOU CAN
PLACE ADVICE, THOSE RESULTS
WONTS BE REPORTED TO PATIENTS
BUT YOU CAN CO-LOCALIZE WITH
PATIENTS YOU'RE RECRUITING.
THESE ARE RESOURCES THE CENTER
HAS.
I'VE TALKED ABOUT MOST OF THESE.
AND I THINK WE'LL TRY TO EXPAND
BENCH TOP EVALUATIONS, I ENJOYED
THE ACME DESCRIPTION OF THEIR
EVALUATION.
OURS IS SIMILAR.
SOME THINGS WE DON'T DO LIKE
BOOK END EVALUATION BUS DO HAVE
STANDARDIZED LIMITED DETECTION
AND REAL CLINICAL SAMPLES WE CAN
TRY.
AND THE FINAL IS BIOREPOSITORY
SAMPLES ARE AVAILABLE TO PEOPLE
WHO APPLY TO SOLICITATION, GREAT
TO AT LEAST APPLY.
YOU DON'T HAVE TO WIN A
SOLICITATION BUT AT LEAST TO
HAVE APPLIED WILL MAKE YOU
ELIGIBLE FOR SAMPLES WE HAVE.
WE HAVE MANY OF SAMPLE TYPES
INCLUDING THROAT, GENITAL,
RECTAL, AND THEN FOR ALL THE
BLOOD-BORNE DISEASES WE HAVE A
WIDE VARIETY OF BLOOD.
VIRAL HEPATITIS CENTER WITH WHOM
WE COLLABORATE, IF YOU'RE
INTERESTED IN SOME OF THESE HEP
B AND HEP C SAMPLES WE HAVE
THOSE.
WITH THAT I THINK I'LL TURN BACK
OVER TO JUE.
>> NEXT IS DR. REBEKAH RICHARDS,
LEADING THE CENTER FOR
INNOVATION AND TRANSLATION OF
POINT OF CAR TECHNOLOGIES FOR
EQUITABLE CANCER CARE, PROFESSOR
OF BIOENGINEERING DIRECTOR OF
RISE 360-DEGREE INSTITUTE FOR
GLOBAL HEALTH TECHNOLOGIES.
>> IT'S A PLEASURE TO BE PART OF
THE TEAM AND HAVE THE
OPPORTUNITY TO TELL YOU ABOUT
CITAC, FOCUSED ON DEVELOPING
TESTS TO IMPROVE EARLY DETECTION
AND TREATMENTS OF CANCER, TO
ADDRESS THE CHALLENGE CURRENT
TESTS ARE TOO COMPLICATED AND
TOO EXPENSIVE, ESPECIALLY FOR
PEOPLE THAT LIVE IN MEDICALLY
UNDERSERVED AREAS.
SO, OUR GOALS AS A CENTER ARE TO
FIRST IDENTIFY WHAT ARE THE HIGH
PRIORITY CLINICAL NEEDS FOR
POINT-OF-CARE CANCER
TECHNOLOGIES.
AND THEN TO HELP ACCELERATE THE
DEVELOPMENT OF AFFORDABLE
TECHNOLOGIES TO MEET THESE
NEEDS.
WE WANT TO HELP INVESTIGATORS
EVALUATE AND IMPROVE CLINICAL
AND PUBLIC HEALTH IMPACT OF
THESE POINT OF CARE
TECHNOLOGIES, IN A DIVERSE RANGE
OF MEDICALLY UNDERSERVED
SETTINGS, AND THEN HELP TRAIN
DEVELOPERS AND USERS TO CREATE
AND DISSEMINATE POINT-OF-CARE
TECHNOLOGIES FOR CANCER THAT ARE
MORE EQUITABLE.
OUR TEAM IS SHOWN ON THE SIDE.
MYSELF, AND INCLUDE THE VICE
PRESIDENT FOR GLOBAL HEALTH AT
BAYLOR COLLEGE OF MEDICINE.
SHE IS HER.
A PROFESSOR OF BIOENGINEERING AT
RICE WILL BE HERE TOMORROW AND
THE EXECUTIVE DIRECTOR OF THE
GLOBAL ONCOLOGY AT M.D. ANDERSON
CANCER CENTER.
WE'RE FOCUSED FOR PRIORITY CANS
SOAR CERVIX, G.I. TRACT, ORAL
CAVITY, ALTHOUGH OF COURSE WE
WILL WORK ACROSS THE ENTIRE
FIELD.
I TOLD YOU ABOUT OUR U.S. MEMBER
INSTITUTIONS.
WE'RE INTERESTED IN UNDERSERVED
SETTINGS IN TEXAS AND UNITED
STATES BUT HAVE MEMBER
INSTITUTIONS WITH BRAZIL, AND
ALSO A LOW INCOME COUNTRY IN
MOZAMBIQUE WORKING WITH UEM AND
MINISTRY OF HEALTH.
WE HAVE A WIDE VARIETY OF
CLINICIANS AND TECHNOLOGY
DEVELOPERS WORKING IN MEDICALLY
UNDERSERVED REGIONSES IN AFRICA,
BRAZIL, UNITED STATES.
WE OFFER ACCESS TO CLINICIANS TO
HELP UNDERSTAND, TO HELP
EVALUATE TECHNOLOGIES, AND THEN
EXPERTS IN USABILITY TO HELP
DESIGN AND EVALUATE THE
USABILITY OF TECHNOLOGIES IN
THESE SETTINGS AND TO LOOK AT
BARRIERS TO ENABLERS AND
ADOPTION IN THESE SETTINGS.
WE HAVE TWO SETS OF UNIQUE
RESOURCES, FIRST IN
COMMERCIALIZATION, TEXAS MEDICAL
CENTER, WE HAVE ACCESS TO A
WONDERFUL SET OF
COMMERCIALIZATION RESOURCES THAT
ARE FOCUSED ON THE COMPANIES
BASED IN THE U.S. AND IN BRAZIL
WE HAVE ACCESS TO RESOURCES
THROUGH A GOVERNMENT-FUNDED
PROGRAM THAT CAN HELP SUPPORT
INNOVATIONS TARGETING CUSTOMERS
IN LOW- AND MIDDLE-INCOME
COUNTRIES AND FANTASTIC
MICROFABRICATION TECHNOLOGIES
FOR FABRICATION AND
CHARACTERIZATION OF
TECHNOLOGIES, MY COLLEAGUE WILL
BE HERE TOMORROW TO SHARE MORE
INFORMATION ABOUT THESE
RESOURCES.
THANK YOU.
>> NEXT IS ASSOCIATE PROFESSOR
OF MEDICINE AT NORTHWESTERN
UNIVERSITY AND HE'S GOING TO
SHARE WITH US THE CENTER FOR
INNOVATION IN POINT-OF-CARE
PARTICULAR NOTHING FOR HIV/AIDS
AND INFECTIOUS DISEASE.
>> YOU HEARD ABOUT CIFAN
ALREADY.
TODAY IT COULD BE AGE RELATED
INCLUDING CANCER, HEART DISEASE,
ALL KINDS OF THINGS.
WE'RE FOCUSED ON LOW AND MIDDLE
INCOME SETTINGS, SUB-SAHARAN
AFRICA.
SALLY IS A CO-P.I. WITH ROB
MURPHY.
ROB HAS BUILT RELATIONSHIPS WITH
ALL THE SITES, VITAL TO WORKING
WITH GLOBAL PARTNERS.
KARA IS IN THE KELLOGG SCHOOL OF
MANAGEMENT, BRINGS MANAGEMENT
AND STRING FOCUS FOR C-THAN.
WE'RE MORE SO OUR PARTNERS IN
SUB-SAHARAN AFRICA.
WE'RE ENIMAGED WITH ALL SITES,
PROJECTS ALL ALL SITES, SOUTH
AFRICA, NIGERIA, MALI, TANZANIA,
ADDING IN SITES IN SENEGAL AND
SOUTH AFRICA, AND TWO
INVESTIGATORS, GOT SO INTERESTED
IN C-THAN, WE BROUGHT THEM IN.
WE'RE EXCITED TO HAVE TWO NEW
SITES, BOTH HAVE DEPARTMENTS OF
BIOENGINEERING, SCHOOLS OF
MEDICINE AND OPPORTUNITIES FOR
TECH DEVELOPMENT.
OUR RESOURCES, EXPERTISE IN THE
TECHNOLOGY DEVELOPMENT AND
MENTORSHIP IN POINT OF CARE TECH
DEVELOPMENT AND
COMMERCIALIZATION, CLINICAL
VALIDATION STUDY DESIGN AND
CONDUCT, AND MUCH LIKE MANY
OTHER SITES WE HAVE DONE A LOT
OF WORK DEVELOPING BIOSPECIMEN
REPOSITORY.
ALL SEVEN SITES WE DID SURVEYS
TO UNDERSTAND SPECIMENS IN TERMS
OF BEING ABLE TO TEST FOR HIV,
TB, VIRAL HEPATITIS, CANCERS.
DISSEMINATION CORE WE'VE DONE
MANY LMIC NEEDS ASSESSMENTS,
RESOURCES, MARKET LANDSCAPE,
ASSESSMENTS THROUGH KARA AND THE
KELLOGG BUSINESS STUDENTS.
WE'VE DONE TRAINING IN MARKET
RESEARCH REGULATORY PATHWAYS,
TRANSFER TO MANUFACTURING SALES
AND DISTRIBUTION.
WE PLAN TO DEVELOP A FEW OTHER
THINGS DURING THE NEXT FUNDING
CYCLE.
WE'VE CONTINUED TO DEVELOP
EXPERTISE IN TRAINING.
WE'VE DECIDED TO FOCUS ON FOUR
WORKING GROUP AREAS FOR
TECHNOLOGY MOST APPLICABLE TO
LOW AND MIDDLE INCOME SETTINGS.
MOLECULAR BIOLOGY, LATERAL FLOW,
, COME AND SEE OUR TABLE.
A LOT IS THIS PRODUCT
ENGINEERING.
WE CALL IT THE GADGETS.
WE EIGHTING A NEW -- CREATING A
NEW WAY TO COLLECT SPUTUM,
BLOOD, IT'S AS MUCH ABOUT
TESTING AS ABOUT ENGINEERING,
HOW YOU COLLECT SAMPLES.
WE'D LIKE TO DO STANDARDIZATION,
AND THEN A FEW OTHER ACTIVITIES
IN THE DISSEMINATION CORE,
JOURNEY MAPPING, OTHER THINGS.
WE'RE OPEN TO SHARING WITH
ANYONE.
WE'RE CONSTRAINED BY OUR LOCAL
PARTNER, SITE REGULATIONS,
OVERSIGHT, AND MATERIAL AND DATA
TRANSFER AGREEMENTS BUT WE'RE
OPEN TO WORKING WITH ANY OF YOU.
THIS IS SOME EXAMPLES OF A FEW
THINGS WE'VE DONE TO ADVANCE
TECHNOLOGIES.
WE'VE HAD A LOT OF PROJECTS,
SMALLER ONES, MAYBE SOME OTHER
POCTRN CENTERS.
AND WE'VE PROVIDED EXPERTISE NOT
JUST TO THOUGH WE FUNDED, MANY
TECHNOLOGY HAVE APPLIED AND HAVE
THIS EXPERIENCE, INDIVIDUALS
APPLIED, REALLY INTERESTING
TECHNOLOGIES OR PROJECTS THAT
COULDN'T FUND OR DIDN'T FIND A
WAY BUT FOUND A WAY TO APPLY FOR
ANOTHER YEAR OR FIND ANOTHER
PATH, OUR MENTORING IS
IMPORTANT.
BUSINESS STUDENTS GOING TO DO
NEEDS ASSESSMENTS, ENGINEERING
STUDENTS, GRADUATE STUDENTS, IN
MALI AND THE UNITED STATES, A
TRAINING OPPORTUNITIES FOR
UNDERGRADS TO GRADUATE STUDE%T,
WORKED WITH YOU ON RADx.
CONTINUED COLLABORATION,
RESEARCH THROUGH SHARING.
IF YOU'RE INTERESTED IN
SPECIMENS.
WE'RE WORKING ON A SIMILAR
RESOURCE FOR HIV VIRAL LOAD,
WE'RE GETTING PLASMA AND WHOLE
BLOOD WITH KNOWN LEVELS OF
DETECTABLE VIRUS, DIFFERENT
LEVELS, TO HELP WITH DEVELOPMENT
OF POINT OF CARE VIRAL LOAD
TESTING ACROSS NIH-FUNDED
NETWORKS TO GET A RESOURCE PUT
TOGETHER FOR PEOPLE FOR POINT OF
CARE VIRAL LOAD.
TECHNICAL VALIDATION, ONE NEW
SITE AT UNIVERSITY OF WITS,
LESLIE SCOTT, THEY WERE DOING
WHAT ACME DID IN TERMS OF
TECHNICAL VALIDATION, SIMILAR
TYPE OF PROCESS THERE,
INTERESTING TO COMPARE TO HOW
ACME DID IT AND EVERYONE ELSE.
THEY WOULD BE GOOD TO WORK WITH.
WE'RE INTERESTED IN WORKING IN
THE FOUR AREAS I HIGHLIGHTED.
I WANT TO ACKNOWLEDGE THE GRANTS
AND FUNDERS.
THANK YOU.
[APPLAUSE]
>> LAST PRESENTATION FOR THIS
PANEL WILL BE DELIVERED BY DR.
DAVID ERICKSON, PROFESSOR AND
SCHOOL OF MECHANICAL AND
AEROSPACE ENGINEER, CORNELL,
FOCUSED ON POINT OFCARE
TECHNOLOGY FOR NUTRITION AND
CANCER IN GLOBAL HEALTH.
>> THANK YOU.
IT'S AN HONOR TO SPEAK, A GREAT
HONOR TO BE HERE RECOMMENDING
THE CENTER, A MEMBER OF THIS
EXPANDED NETWORK AS WELL AS TO
MEET AND SPEAK WITH EVERYONE
HERE TODAY.
WE'RE A NEW CENTER AS NOTED.
OUR FOCUS AGAIN IS ON CENTER OF
POINT OF CARE TECHNOLOGY FOR
NUTRITION, INFECTION, CANCER FOR
GLOBAL HEALTH, QUITE A BROAD
LOOK AT THINGS.
YOU SEE WHY THAT IS IN A BIT.
OUR FOCUS IS SUPPORTING
DEVELOPMENT, DEPLOYMENT,
CLINICAL VALIDATION,
COMMERCIALIZATION OF POINT OF
CARE TECHNOLOGIES IN THOSE THREE
CATEGORIES, NUTRITION,
INFECTION, CANCER, FROM A GLOBAL
HEALTH PERSPECTIVE.
AND WE'LL DO THAT IN LOCATIONS
WHERE ACCESS TO BETTER
DIAGNOSTICS CAN HAVE THE LARGEST
WORLD-WIDE IMPACT.
WE FOCUS ON TECHNOLOGIES THAT
CAN IMPROVE -- ADDRESS PRIMARY
NEEDS OF THE MOST VULNERABLE IN
THE U.S. AND INTERNATIONALLY.
AND IN TERMS OF CONTACT I'M
GOING TO SAY THINGS HERE TODAY.
IN TERMS OF RESOURCES AND WHAT
NOT, YOU'RE WELCOME TO TALK TO
ME AGAIN UPSTAIRS LATER TO TODAY
BUT IF YOU DON'T GET THAT CHANCE
THROUGHOUT THE PRESENTATION HERE
IN THAT CORNER THAT QR CODE,
TAKE A PICTURE, THAT WILL LINK
YOU TO THE WEBSITE AND CONNECT
WITH OUR MAIN POINT OF CONTACT
THERE, PRIYANKA.
OUR CENTER, YOU CAN THINK OF THE
STRUCTURE LIKE THIS.
AGAIN, IT'S ENABLED BY A
ONE-OF-A-KIND INTERNATIONAL
NETWORK ACROSS FOUR CONTINENTS
TO PROVIDE THE SAME RESOURCES
BUT IN A SLIGHTLY DIFFERENT WAY.
THAT CLINICAL TRAINING
FACILITIES, UNIQUE WORLDWIDE
PERSPECTIVE.
WE HAVE FOUR CLINICAL SITES
INVOLVED IN THE TOP CORNER YOU
CAN SEE.
SO IN UGANDA INFECTIOUS DISEASE
INDIA, ECUADOR AND WEILL CORNELL
IN NEW YORK CITY.
IT GIVES OUR CLINICAL REACH
ACROSS FOUR CONTINENTS, A BROAD
SET OF USERS AND SPECIMENS THAT
I'LL TALK ABOUT IN A MINUTE.
ON THE DISSEMINATION CORE SIDE,
WE'RE -- NEEDS ASSESSMENT AND
TRAINING BE DONE THROUGH
PARTNERSHIP WITH MCGILL
UNIVERSITY, COMMISSIONERIZATION
SUPPORT PROVIDED BY COLUMBIA
UNIVERSITY.
I'M EXPLAIN SOME PROGRAMS IN A
MINUTE.
TECHNOLOGY DEVELOPMENT AND ALL
THAT WILL HAPPEN AT CORNELL, IN
ENGINEERING AND NUTRITIONAL
SCIENCES, AND AIL TALK ABOUT OUR
INITIAL PROJECTS TO BEGIN WITH
IN A MINUTE HERE.
SO, CENTER DIRECTORS, AS
MENTIONED, SIMILAR TO OTHER
CENTERS WE HAVE A TECHNICAL,
ENGINEERING P.I. WHICH IS MYSELF
ANDED MY GOOD COLLEAGUE WHO
SHOULD BE HERE TOMORROW IS OUR
CLINICAL DIRECTOR, BOTH OF US
HAVE THAT SORT OF EXPERTISE IN
THOSE AREAS AND OVERLAPPING
INTERESTS WITHIN GLOBAL HEALTH.
OTHER CENTER LEADERSHIP INCLUDES
OUR DISSEMINATION LEADERS,
CLINICAL LEADERS, AND OUR LAB TO
MARKET LEADER.
CLINICAL SITE LEADS AS WELL YOU
CAN SEE THERE FROM OUR FOUR
CLINICAL SITES.
SO WHAT I BELIEVE WE BRING HERE
IS OVER THE NEXT FIVE YEARS TO
THIS NETWORK IS GETTING THE
ABILITY TO VALIDATE
POINT-OF-CARE TECHNOLOGIES ON A
BROAD RANGE OF ESTABLISHED
POPULATIONS IN BIOSPECIMENS
ACROSS THE FOUR CONTINENT
NETWORK THAT I MENTIONED.
I THINK IT'S THE INDIVIDUAL
SITES THEMSELVES BUT AS WE TALK
ABOUT CROSS-POLLINATION OF
DIFFERENT TECHNOLOGIES BEING
USED IN DIFFERENT SETTINGS,
BEING ABLE TO USE MULTIPLES OF
THESE SIDES MIGHT BE AN
INTERESTING PERSPECTIVE.
I'LL TALK ABOUT LAB TO MARKET
ACCELERATION.
A NUMBER OF UNIQUE TRAINING
EXERCISES THROUGH THE PROGRAM
THAT WILL GET STOOD UP IN SHORT
ORDER.
I THINK WHAT A LOT OF TRAINING
EXERCISES WILL BE ARE COUNTRY
SPECIFIC.
SO, AGAIN, TRYING TO UNDERSTAND
HOW MIGHT I APPLY TO THE MARKET
IN DIFFERENT PART OF THE WORLD,
TAKING ADVANTAGE OF EDUCATIONAL
PROGRAMS TO UNDERSTAND WHAT THE
DIFFERENCES ARE IN A REGULATORY
ENVIRONMENT SOMEWHERE ELSE, WHAT
THE DIFFERENCES ARE IN
COMMERCIALIZATION PATHWAYS AND
SO FORTH.
AGAIN, AS WITH OTHER TEAMS YOU
SEE OUR NETWORK OF CLINICAL --
INDUSTRIAL PARTNERS AND THEN
SIMILAR TO OTHER PEOPLE, AGAIN
AN SANDAL NEEDS ASSESSMENT
CONSENSUS, WHAT WE BELIEVE WILL
BE THE NEXT BIG THINGS TO FOCUS
ON.
SO TWO THINGS I WANT TO BRING UP
HERE, TO MENTION TO THIS GROUP
AND MAKE IT AVAILABLE TO THIS
GROUP, AGAIN THESE ARE OUR
PROGRAMS THAT I THINK WE'RE --
WE WANT TO MAKE AVAILABLE AS
BROADLY AS POSSIBLE, MAYBE NOT
PART OF THE NETWORK, FEEL FREE
REACH OUT IF YOU'RE INTERESTED
IN THESE.
THE FIRST IS, AS I SAY, IN
PARTNERSHIP WITH COLUMBIA
UNIVERSITY, A NETWORK IN AND OF
THEMSELVES LAB-TO-MARKET
ACCELERATORS, WE'LL BE STANDING
UP FOCUSED ON GLOBAL HEALTH.
SO WE'RE GOING TO SEE HOW THIS
UPTAKES ITSELF OVER THE NEXT FEW
YEARS BUT WE IMAGINE THERE WILL
BE YEARS IN WHICH COUNTRIES
SPECIFIC AND YEARS BROADLY
SPECIFIC BUT I THINK IT'S A
REALLY GREAT OPPORTUNITY FOR
THOSE OF YOU LOOKING TO, HEY,
HOW DO I COMMERCIALIZE SOMETHING
IN ONE OF THESE OTHER PLACES,
WHAT IS THE POTENTIAL FOR WHAT
I'M DOING IN SOMEWHERE, WHERE
I'M NOT WORKING NOW, THIS MIGHT
BE AN EXCELLENT OPPORTUNITY FOR
THOSE THAT ARE INTERESTED IN
THAT.
THE OTHER THING, WE'VE BUILT UP
THIS LONG STANDING NETWORK OF
CLINICAL SITES AROUND THE WORLD
HERE.
AGAIN, WE THINK OF THESE AS NOT
JUST ACCESS TO A PARTICULAR
PATIENT POPULATION, PARTICULAR
SAMPLES, ACCESS TO LOCAL
EXPERTISE ON THE CLINICAL SIDE
AND TECHNOLOGICAL SIDE,
MANUFACTURING SIDE.
SO THESE, AS WE WORK THROUGH THE
NETWORK OVER THE NEXT FEW YEARS
WE'RE GOING TO BUILD UP OUR
SITES TO PROVIDE A BROAD RANGE
OF -- BRING EXERCISE INTO THIS
KIND OF NETWORK, MAKE IT
AVAILABLE MORE BROADLY.
FINALLY I THOUGHT I WOULD CLOSE
HERE BY SAYING IN OUR FIRST YEAR
WE INTEND TO FUND A NUMBER OF
PROJECTS HERE, AGAIN WHAT YOU
CAN SEE IS THEY ARE PRETTY BROAD
RIGHT NOW.
THEY DO FOCUS ON AGAIN THOSE
FOUR AREAS, NUTRITION, IN TERMS
OF ANEMIA, INFECTIOUS DISEASE IN
TERMS OF MALARIA, AND VARIOUS
STIS, AND THEN HPV IN TERMS OF
CANCER.
WHAT I THINK, THE POINT THINK AS
WE EVOLVE THINKING ABOUT HOW
WHAT YOU'RE DOING MIGHT APPLY TO
ANY NUMBER OF THESE, WONDERING
WHAT YOU'RE DOING MIGHT APPLY TO
A DIFFERENCE AREA, COME TO US
WE'D LOVE TO TALK TO YOU ABOUT
IT.
>> WE HAVE ABOUT 15 MINUTES FOR
QUESTIONS.
I WOULD LIKE TO INVITE ALL
SPEAKERS TO THE STAGE.
AND WHILE YOU ALL THINK ABOUT
QUESTIONS, AFTER YOU HEARD THE
HIGH LEVEL OVERVIEW OF THE
CENTERS AND RESOURCES, THE TEAM
FOCUSES OF THESE CENTERS IF YOU
CAN THINK OF ANY QUESTIONS ABOUT
RESOURCES YOU MIGHT NEED.
I SEE -- GO AHEAD.
>> I HAVE A QUESTION ABOUT
REGULATORY SUPPORT.
AS YOU KNOW, NAVIGATING POC
SPACE CAN BE QUITE DIFFICULT IN
THAT REGARD AND EVEN MURKIER
WHEN YOU HAVE A DEVICE WHOSE
INTENDED USE IS PHARMACIES OR AT
HOME.
I WAS WONDERING WHAT KIND OF
REGULATORY SUPPORT YOU HAVE
THAT'S SPECIFIC FOR POC OR EVEN
HOME TESTING.
THANKS.
>> GREAT QUESTION.
IT IS SOMETHING WE'VE CERTAINLY
DEVELOPED MOSTLY BECAUSE OF
EXPERTISE IN THE TEAM AND YOU
PROBABLY SAW ERIKA, IF YOU WERE
HERE THIS MORNING, TALK TO HER
FOR THE EXPERTISE SPECIFICALLY
TO YOUR QUESTION.
WE TRIED TO CREATE
INFRASTRUCTURE AND ACCESSIBILITY
TO THAT CONSULTATIVE SERVICE,
FOR PEOPLE WHO ARE THINKING OF
CLINICAL USE CASE OR HAVE A
TECHNOLOGY, TRYING TO FIND
PATHWAY FOR REGULATORY APPROVAL
WE CAN HELP THEM WITH THAT.
A LOT OF EXPERTISE IS AROUND
POINT OF CARE, CONSUMER USE
APPLICATION, WE COULD HELP WITH
ALL OF THOSE.
IT'S NOT THAT WE PROVIDE, THE
INTENT IS NOT TO PROVIDE
REGULATORY SERVICE BUT GET ON
YOU THE PATHWAY AND UNDERSTAND
SAND POINT YOU IN THE OTHER
DIRECTION AND PROBABLY GO
FURTHER BUT AT LEAST WITHIN THE
DOMAINS OF WHAT WE CAN DO FOR
INDIVIDUALS AND PARTICULARLY
WITHIN TEAMS THAT COME IN AS
PROJECTS FOR US, THAT'S OUR
INTEND TO MAKE SURE WE GET THAT
DONE FOR YOU.
>> SO AS I WAS LISTENING TO
PRESENTATIONS, A COMMON THEME OF
THE PROVIDING ACCESS TO THE CARE
OR TECHNOLOGY TO BE USED IN
LOW-RESOURCE SETTINGS,
DOMESTICALLY OR GLOBALLY.
I WONDER IF YOU COULD COMMENT ON
WHAT ARE UNIQUE CHALLENGES IN
DEVELOPING TECHNOLOGIES FOR
LOW-RESOURCE SETTINGS AND WHAT
ARE THE RESOURCES THAT MIGHT BE
HELPFUL TO OVERCOME THOSE
CHALLENGES?
>> I CAN START.
HAVING LIVED IN UGANDA FOR FIVE
YEARS, IT'S NOT ALL THE SAME
THING.
THERE'S HUB AND SPOKE,
CENTRALIZED RESOURCES THAT LOOK
LIKE LABS YOU HAVE IN THE U.S.
THERE ARE INFRASTRUCTURE ISSUES
WHERE WE'VE TRIED THINGS THAT
WORK GREAT HERE, THEY DON'T WORK
THERE.
WELL, THEY DON'T WORK WELL IN
RESOURCE LIMITED SETTINGS
BECAUSE THERE'S BROWNOUTS, LOW
ENOUGH THAT YOU GET
INDETERMINATE.
HAVING THINGS THAT SEPARATE YOUR
DEVICE FROM ENERGY OR AT LEAST
HAVE A WAY TO BUFFER THAT ARE
IMPORTANT.
THOSE ARE THE TYPES OF THINGS
YOU MIGHT NOT THINK ABOUT BUT
THEY BECOME HUGE PROBLEMS.
THE OTHER THING IS DUST.
EVERYTHING I OWNED WAS BROWN
AFTER FIVE YEARS.
AND IT'S BECAUSE THERE'S DUST
EVERYWHERE, PARTICULARLY IN
URBAN SETTINGS.
SO THERE'S OPEN AIR CULTURE AND
THINGS GET GUMMED UP.
THINGS WITH A SENSOR, WITH
SOMEBODY WHERE DUST CAN GET IN,
THE ROBUSTNESS REQUIRED AND
TEMPERATURE IS MUCH DIFFERENT.
ONE THING WE MIGHT THINK ABOUT
SINCE WE HAVE SO MANY PEOPLE
INTERESTED IN GLOBAL HEALTH IN
THE CENTER NETWORK WOULD BE TO
PUT TOGETHER SOME SORT OF -- A
TECHNICAL PRODUCT PROFILE MOST
IMPORTANT FOR THOSE SETTINGS.
>> HI, I'M GOING BACK TO THE
QUESTION -- OH, IS THIS ALL
RIGHT?
OH, SORRY.
>> I WAS GOING TO ADD ONE THING
TO THE ANSWER.
I AGREE WITH EVERYTHING THAT WAS
SAID BUT THERE'S ALSO MANY
UNDERRESOURCED SETTINGS THEY ARE
VERY TOUGH SUPPLY CHAIN
PRESSURES, THE SUPPLY CHAIN IS
FRAGILE.
AND THINKING ABOUT EXPIRATION
DATES AND WHO IS GOING TO PAY,
THOSE ISSUES ARE ALSO REALLY,
REALLY DIFFERENT AND VERY
SETTING-DEPENDENT, SO I THINK
PLANNING FOR ADOPTION IS
ESPECIALLY IMPORTANT.
>> I KNOW YOU'VE BEEN WAITING TO
ASK BUT I WANT TO GET A QUICK
POINT IN, ONE OF THE OTHER MAJOR
DIFFERENCES IN THE MODEL THAT WE
HAVE, WHICH IS MORE FOCUSED ON
THE U.S. IS ALSO SAY RURAL
HEALTH, ACCESS IN MANY CASES
SIMILAR SCENARIO THAT YOU WANT
TO TARGET FOR YOUR POINT OF CARE
TECHNOLOGY.
OKAY.
I TALK ABOUT HOSPITAL AT HOME
PROGRAMS, WHERE ARE THEY
DEVELOPING?
NOT IN RURAL AMERICA BECAUSE
JUST LOGISTICS OF SETTING YOUR
CARS OUT AND GETTING YOUR
PERSONNEL OUT TO THE REQUISITE
NUMBER OF PATIENT HOMES TO MAKE
IT FINANCIALLY SUSTAINABLE MAKE
IT SO THAT THESE TYPES OF
INNOVATIVE PROGRAMS THAT MIGHT
LEVERAGE POINT OF CARE
TECHNOLOGY CAN'T EXIST.
THINKING ABOUT CLINICAL CARE
CONSTRUCTS IN THESE REGIONS
WHICH YOU MIGHT THINK THAT IT'S
INTUITIVELY UGANDA IS DIFFERENT
THAN THE U.S. BUT RURAL
MISSISSIPPI IS AS DIFFERENT FROM
THE URBAN AREAS IN MILLENIUM AS
IN SOME CASES UGANDA IS.
SO I WOULD KEEP THAT IN MIND AS
WELL.
SORRY TO KEEP YOU WAITING FOR
THAT.
>> I ALSO WOULD LIKE TO SAY IF
YOU CAN CAN GET A BOTTLE OF
COKE OR PEPSI, YOU CAN, YOU
SHOULD GET THIS.
I FEEL OPTIMISTIC BUT THEY WILL
HAVE TO HAVE A DIFFERENT SHELF
LIFE FOR TRANSPORTATION SAND
HEAT.
IF YOU CAN DO THAT, PUT IT ON
THE COKE TRUCK AND GET IT
ANYWHERE.
>> SORRY I JUMPED IN.
I'M GOING TO GO BACK TO WHAT I
BROUGHT UP AT THE BEGINNING OF
THE MEETING, PUBLIC HEALTH IN
AMERICA.
IF I PUT MY LAB DIRECTOR'S HAT
WHO, WAIT FOR THE NEXT PANDEMIC,
NEXT OUTBREAK, WE NEAT -- NEED
TO GET AWAY FROM SILOED PUBLIC
HEALTH LABORATORIES, WE NEED TO
BE IN THE FIELD GOING TO
VULNERABLE RURAL AREAS.
WE DID NOT DO WELL IN THE LAST
PANDEMIC.
WE NEED AGNOSTIC PLATFORMS TO
ADAPT TO WHATEVER THE NEW
PATHOGEN IS.
HOW DO WE GET PUBLIC HELP
INVOLVED?
I LOVE THE RIGOROUS EVALUATION
OF THESE POINT OF CARE DEVICES
THAT'S GOING ON, I THINK
INFORMATION LIKE THAT IS GOING
TO DO A LOT TO TURN PUBLIC
HEALTH SCIENTISTS OPINION
AROUND.
I HEARD A LOT OF, WELL, IT'S NOT
AS GOOD AS A LAB TEST WHICH
IGNORES THE POTENTIAL, THE
INFORMATION THAT THESE DEVICES
DO GIVE US.
SO THERE'S EDUCATION THERE.
I THINK THE EVALUATION IS GOING
TO BE INCREDIBLE HELPFUL FOR
THAT.
WE ALSO HAVE TO ACCEPT THE FACT
THAT EVEN WHEN THEY ARE NOT
PERFECT, THEY ARE OF VALUE, AND
THE PERFECT MINDSET DOESN'T HELP
US.
SO, MY QUESTION TO YOU IS HOW DO
WE GET PUBLIC HEALTH AND PUBLIC
HEALTH NEEDS INVOLVED IN THESE
CONVERSATIONS?
>> I'M WATCHING FOR FINGERS NEAR
BUTTON.
I WON THAT ONE.
ONE STORY I WANTED TO SAY, FIRST
YOU MADE SEVEN EXCELLENT POINTS.
I WILL TACKLE ONE OF THEM WHICH
IS IN THE CONTEXT OF RADx AT
LEAST I WANT YOU TO THINK ABOUT
THE FOLLOWING PROGRAM THAT I
THINK IS DR. ANDREW -- YEAH, IS
HE -- YOU'LL BE HEARING A
DIGITAL HEALTH PANEL LATER WITH
SOMEONE WHO STOOD UP A
FASCINATING PROGRAM WHICH WAS
TAKING THE DIGITAL
INFRASTRUCTURE THAT HAD BEEN
BUILT FOR CLINICAL STUDIES POINT
OF CARE DIAGNOSTICS WORKING ON
DIRECT PUBLIC HEALTH REPORTING
SO REGIONS PUBLIC HEALTH OR
LABORATORY DIRECTOR OR DPH WOULD
BE NOTIFIED THE SAME MOMENT THE
PATIENT HAD THEIR RESULTS OF
THEIR POINT-OF-CARE DIAGNOSTIC.
I THINK THAT IS ONE ENTREE
BECAUSE THE CURRENT SYSTEM
RELIES ON MULTIPLE REPORTERS,
DROPOUT OF INFORMATION, PUBLIC
HEALTH RELIES ON GOOD DATA.
IF POINT OF CARE DEVELOPERS
COULD CONSIDER USING PLATFORMS
TO SHARE THAT DATA, BE IT 90% OR
92%, LET THE PUBLIC HEALTH
AGENCIES DEAL WITH THAT, GET THE
DATA TO THEM BECAUSE I THINK
TIME SENSITIVITY AND ACCURACY
ARE WEIGHTED CONCERNS, TIME
SENSITIVITY IF I'M MANAGING
PUBLIC HEALTH WOULD WEIGH MORE
HEAVILY, JUST A STORY TO ADDRESS
YOUR POINT.
>> TO ADDRESS THE ISSUE OF DATA,
I MEAN, I KNOW THERE'S A HUGE
ARGUMENT ABOUT PRIVACY.
IF WE COULD HAVE HOME USE
DEVICE, POINT OF CARE DEVICE,
THAT TRANSMITTED ZIP CODE
POSITIVITY, MAYBE GENDER, I
MEAN, THAT IS VALUABLE
INFORMATION THAT GOES TO THE
HEALTH DEPARTMENT, MAYBE COUPLED
WITH DATA FROM PHARMACIES ON HOW
MANY TESTS ARE BEING PURCHASED
IN THAT AREA.
HEY, THERE'S SOMETHING GOING ON
HERE.
YOU KNOW, AGAIN NOT PERFECT BUT
--
>> I WAS GOING ADD, OUR CENTER
IS MORE INTERNATIONAL BUT
TALKING ABOUT THE INTERNATIONAL
QUESTION OF REGULATION,
DESIGNING FOR SETTING, IT'S ALL
A PARTNERSHIP.
WE NEED TO PARTNER WITH PUBLIC
HEALTH AGENCIES EARLY ON, THE
TECHNOLOGY DEVELOPMENT, AS WE'RE
DOING WITH ALL OF OUR
INTERNATIONAL SITES.
YOU MAY ASK ABOUT SOME
ENVIRONMENTAL CONDITIONS OR
REGULATORY ISSUES.
WE WOULD PROVIDE A RESOURCE TO
HOOK YOU IN WITH COUNTRIES WHO
DEALT WITH THESE ISSUES AND KNOW
WHAT THEY ARE.
ANDs SIMILAR PROCESS WITH
PUBLIC HEALTH GETTING THEM
INVOLVES EARLY ON, MAYBE AS A
PARTNER, SOMEHOW IN SOME
CENTERS, I DON'T KNOW HOW THAT
WOULD WORK, ONE EXAMPLE IS IN
THE CENTERS FOR AIDS RESEARCH,
OURS IN CHICAGO, THIRD COAST
CENTER, ONE OF THE FIRST WITH
THE CHICAGO DEPARTMENT OF PUBLIC
HEALTH WITHIN OUR CENTER.
THERE'S SCIENTIFIC DEVELOPMENT
CENTERS BUT PUBLIC HEALTH IS
THERE WITH A SEAT AT THE TABLE,
MAYBE SOMETHING TO THINK ABOUT
HERE.
>> PART IS ALSO MONEY.
DURING RADx THERE WAS A LOT OF
MONEY.
MAKE MY TEST COUNT THOUGH IT'S A
FRACTURE OF THOSE DONE, TRACKS
WITH WHERE CASES WERE IN THE
UNITED STATES.
THERE MAY BE 1/100 OF A PERCENT,
IT TRACKS.
RADx PAID FOR CONCENTRATION
CAPTURE TECHNOLOGY THAT LED
TOWEIGHT WATER SURVEILLANCE
WHICH TURNED OUT TO BE -- WASTE
WATER SURVEILLANCE WHICH IS
USEFUL.
THERE ARE SPILLOVER EFFECTS BUT
MAKING IT FRONT AND CENTER FROM
THE BEGINNING IS IMPORTANT.
RADx UNDERSERVED SPEECH, U-P
WAS PART OF THE PROGRAM FROM THE
BEGINNING.
A LOT OF MONEY MADE SURE PEOPLE
IN RURAL PLACE WOULDS HAVE
ACCESS TO DIAGNOSTICS AS PEOPLE
IN URBAN CENTERS OR TROLLING THE
KNELT FOR FREE TESTS.
THE OTHER POINT I MIGHT FLAG
THAT FOR ANY OF YOU INTERESTED
IN THIS RIGHT NOW THE FDA HAS A
COMMENT PERIOD UNTIL DECEMBER 4
TO LAB DEVELOPED TESTS,
IMPACTING DISEASES IN THE UNITED
STATES WHERE INCIDENCE IS LOW IF
WE GET RIDSED OF ALL LAB
DEVELOPED TESTS IT WILL
DESOLATES OUR ABILITY TO, FOR
EXAMPLE, DIAGNOSE TUBERCULOSIS,
WE DON'T HAVE MANY CASES BUT
THAT'S RIDS -- RIDICULOUS WE
DON'T HAVE THE LEVEL OF
DIAGNOSTICS.
I URGE YOU TO WRITE A LETTER TO
THE FDA BECAUSE MANY OF THOSE
ARE IMPORTANT.
NOT TO GET POLITICAL BUT I THINK
IT'S IMPORTANT.
>> WONDERING IF EXISTING OLDER
CENTERS COULD COMMENT ON BASED
ON USUAL BASED ON PAST
EXPERIENCE ON RESOURCES FROM
INNOVATORS COMMUNITY AND ARE
THERE DIFFERENT TYPES OF
TECHNOLOGIES REQUIRING DIFFERENT
SERVICES OR DO WE SEE CHANGE
OVER TIME?
>> AS A PREDOMINANTLY
TECHNOLOGY-SEC TRICK OR
DISEASE-AGNOSTIC CENTER, IT DOES
VARY QUITE A LOT.
WE'VE SEEN OF COURSE FROM
MICROFLUIDICS, APP DEVELOPMENT,
CONVENTIONAL POINT OF CARE TESTS
THAT WE'RE ALL FAMILIAR WITH,
AND ENGINEERING SIDE THERE'S THE
ABILITY TO OPTIMIZE OR IMPROVE
AND MAKE CHANGES THERE.
THAT'S ONE ASPECT.
WE HAVE REALLY ACCELERATED
UNDERSTANDING AND THE ANALYTIC
VALIDATION PIECES IN THE
LABORATORY AND CLINIC, AND
THAT'S ONE I THINK WE REALLY
HAVE EXPANDED OUR OFFERINGS OF
EVERYTHING FROM THE STORAGE
SAMPLES, BIPARTISANSHIP,
SYNTHETIC SAMPLES AND ABILITY TO
DO IT PROSPECTSIVELY AND IN
DIVERSE POPULATIONS, A LOT OF
WHAT HAS CHANGED IN THE LAST FEW
YEARS, I'M REWHETHER YOU CAN
TAINT D. -- RELUCTANT TO THINK
THE PANDEMIC DID SOMETHING GOOD
BUT WE'VE LEARNED A LOT.
>> WE'VE TALKED ABOUT MOVEMENT
OF HEALTH CARE OUTSIDE OF THE
TRADITIONAL CONSTRUCT OF
IN-HOSPITAL OR IN-CLINIC CARE
BUT USER GROUPS THOUGHT ABOUT
AND TRAINING REQUIRED TO GET
THEM TO BE SAVVY USERS HAS
CHANGED A LOT WITH MORE
TARGETING OF PARAMEDICS AND
IN-HOME NURSING, THERAPISTS.
THE OTHER AS GREG MENTIONED, APP
DEVELOPMENT.
NOW EVERYBODY HAS AN APP, THAT
INTRODUCES A.I. AND OTHER
ELEMENTS INTO THE CONVERSATION.
I MENTIONED BEFORE, I DIDN'T
LINK -- THE CONCEPT OF
INTEROPERABILITY AND
ACCESSIBILITY ARE LINKED,
ADDRESSING HEALTH DISPARITIES,
THAT'S SOMETHING THAT WE'VE BEEN
INTENTIONAL ABOUT TALKING MORE
WITH OUR COMPANIES ABOUT.
I DON'T KNOW THAT THEY
NECESSARILY HAVE BEEN DRIVING
THAT BUT THAT'S MORE PART OF THE
CONVERSATION.
ON THE OTHER END ACCESSIBILITY
AND INTERPRETABILITY AND EXPLAIN
JACKET PARTICULARLY WITH A --
EXPLAINABILITY.
>> FOR ME IT'S PERFORMANCE AND
MATRIX AND SAMPLES.
IT WORKS IN BUFFER, DOESN'T MEAN
IT'S GOING TO WORK IN A YUCKY
VAGINAL SWAB, TO BE CLEAR ABOUT
STIS, AND THE OTHER AREA WHERE
PEOPLE UNDERESTIMATE IS YOU HAVE
TO CHOOSE A USE CASE.
I THINK IT'S SO INTERESTING HOW
EVERYONE THINKS A TEST CAN BE
GOOD FOR EVERYONE.
I REMEMBER THE EARLY PART OF
RADx A COMPANY AWAY YOU COULD
USE THIS IN IMMEDIATEAL LAB,
POINT OF CARE, MAYBE OVER THE
COUNTER.
NOT REALISTIC, ALL DIFFERENT USE
CASES AND TECHNICAL PROFILES, IT
COULD BE A SMALL MARKET BUT IF
YOU CREATE SOMETHING FOR THAT
MARKET YOU WOULD BE VERY
SUCCESSFUL.
THOSE ARE THE TWO THINGS, ACCESS
TO CLINICIANS TO SAY WHICH TEST
YOU SHOULD MAYBE MULTIPLEX
TOGETHER OR WHAT WE THINK WOULD
BE USEFUL SO PICK A USE CASE AND
THEN SAMPLES IN MATRIX.
>> AS A TECHNOLOGY DEVELOPER ONE
OF THE THINGS THAT I'VE SEEN
THAT'S BEEN QUITE VALUABLE
THROUGH THIS NETWORK IS HAVING A
LITTLE BIT OF TALES OR
UNDERSTANDING OF WHAT THE
REGULATORY ENVIRONMENT IS GOING
TO LOOK LIKE WHERE YOU HOPE TO
GET IN AS EARLY AS POSSIBLE IN
TECHNOLOGY INVESTIGATOR.
.
IT DOESN'T HAVE TO GUIDE BUT
HAVING AWARENESS AROUND THAT HAS
BEEN INCREDIBLY VALUABLE IN
TERMS OF THINGS I'VE BEEN ABLE
TO GET ACCESS TO MORE QUICKLY
EARLIER.
>> WE'RE IN UNIQUE SETTINGS, A
KEY ASPECT.
PROVIDING TECHNICAL EXPERTISE,
SALLY AND ENGINEERING TEAMS
HAVE, BUSINESS ASPECTS OF
MARKETING, UNDERSTANDING MARKET
LANDSCAPE, NEEDS, CLINICAL
NEEDS, AND WRAPPED INTO THAT IS
SOME OF THE REGULATORY
MANUFACTURING ISSUES THAT KARA
AND THE KELLOGG TEAM BRING TO
THE TABLE.
>> I THANK WE'RE AT TIME.
PLEASE JOIN ME IN THANKING THE
PANELISTS AND SPEAKERS FOR TIME
AND INSIGHT.
[APPLAUSE]
>> THIS WILL BE A RAPID PITCH
SESSION ON THE E-POSTER AND
EXHIBIT SESSIONS FOR TODAY.
WE'LL HAVE SUSAN TO GO THROUGH
THE PRESENTERS FOR TODAY.
YOU.
>> THANKS YOU FOR BEING ON THE
AGENDA.
WE'RE EXCITED TO HAVE OUR SEVEN
PRESENTERS HERE TODAY.
THESE ARE ALL OF OUR COMPANIES
OR TECHNOLOGIES.
I WANT TO ASK ALL TEN SEVEN
PRESENTERS IF YOU COULD COME
DOWN TO THE FRONT, JUST TO MAKE
SURE WE'RE READY TO GO.
WE'LL BE GOING IN THIS ORDER.
WITH THAT, FIRST UP IS TODD
ALLEN OF HEMO SONIC, PRESENTING
THE 15-MINUTE BLOOD CLOT
ANALYZER.
>> THANK YOU FOR THIS
OPPORTUNITY TO PRESENT OUR
TECHNOLOGY.
HEMOSONICS WAS FOUNDED IN
CHARLOTTESVILLE VIRGINIA AT UVA.
WE HAVE OPERATIONS AND
MANUFACTURING IN DURHAM, NORTH
CAROLINA.
OUR TEAM IS SOLELY FOCUSED ON
DELIVERING CRITICAL AND
ACTIONABLE INFORMATION RAPIDLY
AT THE POINT OF CARE.
OUR SOLE PRODUCT AT THIS TIME IS
THE QUANTRA DEVICE.
BLEEDING SAND TRANSFUSIONS LEAD
TO WORSE PATIENT OUTCOMES AND
INCREASING COSTS.
STANDARD LAB TESTS ARE NOT
ADEQUATE FOR MANAGING ACUTE
BLEEDING DUE TO FACTORS THAT
DELAY RESULTS TO PHYSICIANS.
WHOLE BLOOD TESTING AT THE POINT
OF CARE PROVIDES THE MOST RAPID
ACTIONABLE RESULTS FOR
CORRECTING THERAPY, THERAPEUTIC
DECISIONS, TO HELP STOP
BLEEDING.
IT IS INNOVATIVE, USES
ULTRASOUND-BASED TECHNOLOGY TO
MEASURE ELASTIC PROPERTIES OF
BLOOD AS THE CLOT FORMS.
THE CARTRIDGE ELIMINATES NEED
FOR SAMPLE MANIPULATION AND
LABORATORY SKILLS.
THE SAMPLE IS ARTERIAL OR VENOUS
WHOLE BLOOD, COLLECTED IN
CITRATED TUBE, WITH CURRENTS FDA
INDICATION FOR PERIOPERATIVE
SETTING FOR AASSESSING
HEMOSTASIS AND LASER FOCUSED ON
OUR NEXT INDICATION IN MATERNAL
HEMORRHAGE.
MANUFACTURING CAPABILITY IS
UPWARDLY SCALABLE BUT CURRENTLY
AT 30,000 CARTRIDGES PER MONTH,
30 DEVICES.
WE'RE PRIVATELY HELD COMPANY SO
OUR SALES ARE CONFIDENTIAL BUT
WE HAVE ANNUAL DOUBLE DIGIT
GROWTH.
PERFORMANCE HAS BEEN
DEMONSTRATED IN SEVERAL STUDIES,
ANALYTICAL PERFORMANCE
DEMONSTRATES PRECISION AND
REPRODUCIBILITY.
STRONG CORRELATIONS WITH
STANDARD LAB TESTING AND
HISTORICAL VISCOELASTIC
PLATFORM.
WITH STRONG CONCORDESANCE WITH
BLEEDING INDICES AND ABILITY TO
DETECT COAGULOPATHY IN INDICATED
AREAS OF USE.
WE'VE DEMONSTRATED REDUCTION IN
TRANSFUSION REQUIREMENTS,
ASSOCIATED COSTS.
QUANTRA ELIMINATES NEED FOR
SPECIAL LABORATORY SKILLS SUCH
AS PIPETTING OR REAGENT
HANDLING, ELIMINATES DRY FOR
OBTAINING ACTIONABLE RESULTS,
ALLOWSES FOR ACCURATE
INTERPRETATION OF RESULTS DUE TO
OUR INTUITIVE PRIMARY OUTPUT,
SUPPORTED BY SEVERAL READER
STUDIES.
WE HAVE THE BROADEST INDICATION
FOR POINT OF CARE-BASED
VISCOELASTING TESTING.
CHALLENGES INCLUDE ANY TYPE OF
OFF-LABEL USE, RESULTING IN
CHANGE OF COMPLEXITY THAT
INCREASES THE LABOR AND COST
BURDEN TO THE HEALTH CARE
SYSTEM.
OUR VISCOELASTIC TECHNOLOGIES
CREATE A CHANGE IN WORKFLOW
ESPECIALLY TO THE LABORATORY.
AND FINALLY I WOULD SAY WE DO
HAVE AN INTEREST TO COLLABORATE
IN THE AREAS OF CLINICAL
DECISION SUPPORT SOFTWARE,
A.I.-BASED LEARNING MODELS FOR
PREDICTION, AND SYNERGISTIC
TECHNOLOGIES POSITIONED AT THE
POINT OF CARE AND CRITICAL CARE
SETTINGS.
THANK YOU FOR YOUR TIME.
[APPLAUSE]
>> NEXT UP WE HAVE NEURASTASIS
FOR ACUTE STROKE.
>> THANK YOU, I'M CO-FOUNDER,
BASED IN HOUSTON, SPIN OUT
UNIVERSITY OF TEXAS, SUPPLY
BACKGROUND IS BIOMEDICAL
ENGINEERING, OUR COLLABORATORS
ARE EXPERT IN STROKE, RESEARCH,
CARE.
WE'VE RECEIVED SUPPORT THROUGH
NIH BLUEPRINTED MED TECH
PROGRAM, WORKING WITH CIMIT.
WE'RE FOCUSED ON ACUTE ISCHEMIC
STROKE, ONE OF THE LARGEST
CAUSES OF ADULT DISABILITY.
IN THE PAST DECADE
MECHANOTHROMBECTOMY, STROKE TIME
IS BRAIN, TWO MILLION NEURONS
DIE EVERY MINUTE.
THE ODDS OF A GOOD FUNCTIONAL
OUTCOME DECLINE RAPIDLY.
THIS TYPE OF PROCEDURE IS
PERFORMED AT COMPREHENSIVE
STROKE CENTERS, PATIENTS HAVE TO
TRANSFER THROUGH HUB AND SPOKE
MODEL.
THIS CAN TAKE HOURS IN THE
UNITED STATES.
WHAT WE'RE AIMING TO DO IS USE
NEUROMODULATION TO SLOW DOWN
RATE OF DAMAGE IN STROKE
PATIENTS BEFORE THIS PROCEDURE.
WE USE ELECTRICAL STIMULATION OF
THE VAGUS NERVES TO INDUCE
BRAINSTEM AUTONOMIC REFLEXES,
IMPROVING BLOOD FLOW AND
INTERRUPT CELL-DEATH PATHWAYS,
PACKAGED FOR SINGLE PATIENT USE
APPLIED ACROSS MULTIPLE CARE
SETTINGS INCLUDING PATIENT
TRANSFERS, THIS SHOWS FUNCTIONAL
STIMULATOR.
ALMOST 700,000 PEOPLE IN THE
U.S. SUFFER ISCHEMIC STROKE
ARTICLE EACH YEAR.
ACCESS TO THE PROCEDURE REMAINS
LOW.
WE'RE AIMING TO SLOW DOWN RATE
OF DAMAGE TO GET MORE PATIENTS
TO THIS PROCEDURE AND GIVE THEM
A CHANCE OF BETTER OUTCOME.
FIRST INDICATION WILL TARGET
APPLICATION WITHIN THE EMERGENCY
ROOM, AFTER THE STROKE IS
DIAGNOSED, AND TRANSFER DECISION
IS MADE BUT LONG TERM HOPE TO
GET IT IN THE COMMUNITY FOR EMS
FOR EARLY TIME POINTS.
WE'RE WORKING WITH CIMIT THROUGH
THE BLUEPRINT MED TECH PROGRAM
TO CONDUCT ANIMAL SAFETY TESTING
AND USABILITY TO ENSURE IT
DOESN'T CAUSE DELAYS, TO APPLY
FOR EXEMPTION FROM FDA AND
FEASIBILITIES STUDIES.
I'LL WRAP UP.
THANK YOU FOR YOUR TIME.
[APPLAUSE]
>> THANK YOU.
NEXT UP WE HAVE DR. ANDREA
CUBET, PREDICTING POSTPARTUM
DEPRESSION.
>> THANK YOU FOR BEING HERE.
I APPRECIATE EVERYTHING YOU DO
FOR DEVELOPING EARLY
TECHNOLOGIES.
IT'S AN IMPRESSIVE FEAT.
REALLY APPRECIATE THAT.
THE ENLIGHTEN TEST, OUR STORY
STARTS ABOUT A DECADE AGO,
CO-FOUNDERS, NOW HEAD OF SUICIDE
PREVENTION AT ROYAL INSTITUTE
CANADA, JENNIFER, IN 2013 TALKED
ABOUT STRATEGIES TO TRY AND
PREDICT MENTAL ILLNESS IN
HUMANS.
THEY CAME UP WITH HYPOTHESIS
ABOUT EPIGENETICS.
THEY PICKED A MODEL FOR HUMAN
MENTAL ILLNESS REPLICATABLE AND
COULD BE EASILY STUDIED,
POSTPARTUM DEPRESSION.
WOMEN HAVE TWICE THE RATE OF
MAIN DEPRESSION AS MEN BUT NOT
BEFORE ADOLESCENCE AND AFTER
MENOPAUSE, A CLUE IT'S
HOMOGENOUS BASED AROUND A SEX
DIFFERENCE.
A DECADE LATER WE NOW HAVE WELL
VALIDATED BIOMARKERS, REALLY
PROVIDE INSIGHT NOT JUST ON
POSTPARTUM DEPRESSION BUT A
WHOLE RANGE, PRECISION
PSYCHIATRY TO PREVENT DISEASE
BEFORE IT BECOMES A PROBLEM.
NOW A DECADE AFTER THAT INITIAL
STUDIES ARE COMPLETED WE HAVE
NEUROIMAGING DATA TO CONFIRM THE
PLACES WHERE THEY ARE EXPRESSED
IN THE HUMAN BRAIN AND WE HAVE A
MORE COMPELLING DATA THAT THEY
CAN PREDICT RESPONSEIVENESS TO
THINGS LIKE SSRIs.
WE LIKE MANY OTHER PEOPLE ARE
COMBINING WITH A.I. APPROACH AND
DIGITAL HEALTH.
THIS IS WORK FROM ZAK KAMINSKI,
IT'S ABILITY TO UNDERSTAND AND
INFER MOOD AND ANXIETY AND
SOCIAL MEDIA, ANDS WE'VE NOW
EXTENDED THAT, PEOPLE TALKED
TODAY ABOUT MATERNAL MORTALITY
RATES AND CRISIS IN AMERICA, 70%
INCREASE IN THE LAST DECADE.
OUR USE IS TO ADDRESS CHALLENGES
AND MENTAL HEALTH POSTPARTUM,
THE LEADING CAUSE AFTER
HEMORRHAGE, SUICIDALITIES, POOR
OUTCOMES FOR THE MOTHER AND BABY
AND SOCIETY AS A WHOLE. THERE
IS CURRENTLY NO SIMPLE TEST FOR
POSTPARTUM DEPRESSION, SO
TECHNOLOGY AS I SAID HAS A
CUSTOMARY GENETIC CHIP, ABILITY
TO MEASURE DIETARY FACTORS,
FOLIC ACID, IRON, OMEGA-3 FATTY
ACIDS, LEAD, MERCURY, SECONDS
HAND SMOKE, DIESEL FUMES,
BIOLOGICAL FACTORS, TIME TO
MENOPAUSE, OTHER FACTORS.
A DECADE AFTER THE ORIGINAL
DISCOVERY VALIDATED IN SEVEN
COHORTS, 600 PATIENTS, THE PRIZE
IS $65, THAT WILL DROP TO $10 AS
WE DEVELOP CHIPS.
CLINICAL IMPACT WE WANT TO MAKE
THIS TEST STANDARD OF CARE, MOST
WOMEN GET TO SUFFER GESTATIONAL
DIABETES, THIRD TRIMESTER,
POSTPARTUM IS THE MOST COMMON
COMPLICATION.
THE BIGGEST CHALLENGES IS
FINDING A FUNDABLE SOURCE TO GET
THIS IN THE HANDS OF PEOPLE WHO
NEED IT.
IF WE WORK WITH TRIBAL NATIONS
OR POOR UNDERSERVED COMMUNITIES
THEY ARE INCREDIBLY ADVERSE TO
GETTING TESTING.
IF YOU MENTION GENETIC TESTING
IT'S EVEN WORSE.
WE NEED TO BUILD TRUST.
WE WOULD LOVE TO TALK TO ANYONE
WORKING IN COMMUNITIES AND WE'RE
OPEN TO COLLABORATIONS WHERE
THIS IS A KEY ROLE, FOR EXAMPLE
HORMONE THERAPY.
IVF, HORMONAL DEPRESSION IS
ASSOCIATED WITH CANCER
TREATMENT.
ALL THE IMPORTANT CASES WHERE WE
THINK WE HAVE AN IMPORTANT KEY
TO HELP PEOPLE.
THANK YOU SO MUCH.
[APPLAUSE]
>> THANK YOU, ANDREA.
NEXT UP IS ARMOR MEDICAL,
PRESENTING MATERNAL ARMOR A
WEARABLE INNOVATION TO DETECT
HEMORRHAGE.
>> THANK YOU, SUSAN.
HELLO, I'M KELSEY, I'M AN
ENGINEER, A MOTHER, I'M A
SURVIVOR OF HEMORRHAGE.
AND THROUGH MY OWN LIVED
EXPERIENCES AND BECAUSE I'M
USUALLY PASSIONATE ABOUT
TRANSLATING INNOVATIONS WHERE
THEY CAN TRULY HELP PEOPLE, I
CO-FOUNDED ARMOR MEDICAL IN
2020, A BIOMEDICAL DEVICE
COMPANY PIONEERING SOLUTIONS
THAT PROTECT AND EMPOWER WOMEN'S
HEALTH AT EVERY STAGE OF LIFE.
RIGHT OUT OF THE DATE WE'RE
STARTING WITH THE GLOBAL LEADING
CAUSE OF MATERNAL DEATH WHICH IS
SEVERE BLOOD LOSS AFTER
DELIVERY, POSTPARTUM HEMORRHAGE.
WE'VE HEARD ABOUT THIS
THROUGHOUT THE DAY.
ONE TRAGEDY THREE TIMES MORE
DEADLY FOR PEOPLE OF COLOR AND
FOR EVERY PERSON WHO DIES 100
MORE SUFFER DEVASTATING
COMPLICATIONS.
IMPORTANTLY AS MUCH AS 90% OF
THE DEATH AND SEVERE
COMPLICATION FROM HEMORRHAGE IS
PREVENTIBLE, IF YOU CAN DETECT
IT EARLY AND TREAT IT EARLY.
OUR PEOPLE AT ARMOR DEVELOPED
MATERNAL ARMOR, A WRIST-WORN
SENSOR THAT DETECTS EARLY
HEMORRHAGE IN PREGNANT PATIENTS.
AND IF YOU THINK ABOUT OUR
PATENTED TECHNOLOGY THE KEY TO
THIS BREAKTHROUGH IS OUR ABILITY
TO SENSE THE SUBTLE CHANGES IN
PERIPHERAL BLOOD FLOW THAT
HAPPEN DURING THE EARLIEST
STAGES OF HEMORRHAGE WHEN OUR
BODY SHUNTS BLOOD FROM OUR
EXTREMITIES TO OUR CORE TO
PROTECT VITAL ORGANS.
AND SO WE HAVE DONE EXTENSIVE
TESTING ON THIS TECHNOLOGY.
IT'S BEEN VALIDATED IN
PRE-CLINICAL SWINE HEMORRHAGE
MODELS, DOING CLINICAL
FEASIBILITY TESTING AT
WASHINGTON UNIVERSITY IN
ST. LOUIS AND RESULTS FROM THESE
STUDIES SHOW THE SIGNAL FROM OUR
DEVICE HAS A STRONG ASSOCIATION
WITH KNOWN HEMORRHAGE OR BLOOD
LOSS EVENTS AS WELL AS
RESUSCITATION.
IN ADDITION OVER THE LAST YEAR
WE'VE BEEN TALKING WITH PATIENTS
AND TALKING WITH PROVIDERS AND
CO-DESIGNING OUR DIE VICE WITH
THEM AND AS A RESULT OF THE
PROGRESS WE'VE MADE WE'RE
CURRENTLY ON TRACK FOR
COMPLETING OUR PRE-MARKET
CLINICAL STUDIES OVER THE NEXT
YEAR, SO TO SUPPORT REGULATORY
CLEARANCE AND COMMERCIALIZATION
IN 2025.
SEWS WHEN I LOOK AT OUR GOAL,
WE'RE GOING TO REVOLUTIONIZE BY
PROVIDING PROVIDERS WITH
OBJECTIVE TIMELY INFORMATION
ABOUT A PATIENT'S HEMORRHAGE
RISK.
IF YOU THINK ABOUT THIS, WE
EMPOWER CLINICIANS, WHEN WE
EMPOWER CLINICIANS TO DETECT
HEMORRHAGE EARLY WE'RE ENABLING
THEM TO TREAT IN A TIMELY MANNER
SAVING LIVES, REDUCING
COMPLICATIONS AND LOWERING COST
OF CARE.
NOW AS I REFLECT ON THE PROCESS
I'D LIKE TO TAKE A LITTLE BIT OF
TIME TO THANK HHS FOR BEING
GENUINELY A CATALYST AND LAUNCH
PAD FOR OUR COMPANY AND
TECHNOLOGY.
THE TECHNOLOGY ITSELF WAS ACTUAL
BORN OF NICHD K99/R00 AWARD,
PARTICIPATING IN POCTRN'S
CHALLENGE IN 2022, GOT AN SBIR
AWARD FROM THE CDC, AND THEN WE
GOT INTO RADx.
SO THIS JOURNEY HAS BEEN
INCREDIBLE.
I CAN SAY IT'S BEEN INSTRUMENTAL
IN OUR SUCCESS.
AND SO WITH THAT WE'RE SEEKING
PARTNERSHIPS IN THE AREAS ON THE
BOARD HERE AND I WELCOME PEOPLE
TO FIND ME AT THE DEMO AND JOIN
US IN DARING TO INNOVATE A
BETTER HEALTH FOR ALL.
THANK YOU.
[APPLAUSE]
>> NEXT UP WITH RICE UNIVERSITY
WE HAVE MARIA BADA, PRESENTING
ON INTEGRATIVE TESTS AT THE
POINT OF CARE IN LOW-RESOURCE
SETTINGS.
>> OUR TEAM IS RESEARCHES AT
COLLABORATORS AT RICE, M.D.
ANDERSON.
CERVICAL CANCER IS PREVENTIBLE,
MAJORITY CAUSED BY INFECTION,
WHY THE W.H.O. RECOMMENDS HPV
DNA TESTING FOR SCREENING.
TESTING IS EXPENSIVE AND
REQUIRES TRAINED PERSONNEL AND
COMPLEX EQUIPMENT DIFFICULT TO
IMPLEMENT IN THE LOW-RESOURCE
SETTINGS WHERE THE MAJORITY OF
CASES OCCUR.
THIS MAP SHOWS WHERE THE
MAJORITY OF CERVICAL CANCER
RELATED DEATHS OCCUR, IN LOW-
AND MIDDLE-INCOME COUNTRIES.
THIS ALSO HAPPENS IN THE U.S.
SEASON HERE IS THE RIO GRANDE
VALLEY WHERE VERY FEW ELIGIBLE
WOMEN ARE BEING SCREENED FOR
CERVICAL CANCER.
AND WE SEE HIGHER RATES THAT ARE
SIGNIFICANTLY HIGHER COMPARED TO
THE REST OF THE UNITED STATES.
WITH A LOW COST POINT OF CARE
TEST WE CAN MAKE CERVICAL CANCER
SCREENING ACCESSIBLE AND PROVIDE
SCREENING AND TREATMENT IN A
SINGLE VISIT ALLOWING US TO
REDUCE THE PATIENTS LOST TO
FOLLOW-UP.
OUR TECHNOLOGY IS A TEST FOR THE
TWO MOST COMMON TYPES, 16 AND
18, USES POINT OF CARE FRIENDLY
SAMPLE PREPARATION METHOD, IN
AND RPA, WE USE A LATERAL FLOW
READOUT, INTEGRATED ON A
PLATFORM PICTURED HERE INCLUDING
TWO HEAT BLOCKS AND ENCLOSED
CARTRIDGE USING SWAB SAMPLES,
LESS THAN $5 FOR CONSUMABLES,
$1,000 FOR INSTRUMENTATION.
THIS AS A LIMIT OF DETECTION OF
500 TO 1,000 COPIES AND 93%
SENSITIVITY FOR HPV 16 AT LOWER
LIMIT OF DETECTION.
THE REAGENTS AND INSTRUMENTATION
ARE COMMERCIALLY PRODUCED
CURRENTLY.
OUR TEST HAS POTENTIAL FOR HPV
DNA TESTING AND TREATMENT TO OF
IN A SINGLE VISIT SAND LOW COST
ALTERNATIVE TO MANY CURRENTLY
AVAILABLE HPV DNA TESTS.
SOME CHALLENGES INCLUDE
INCORPORATING MORE HIGH RISK
TYPES IN THIS ASSAY WHICH WE'RE
CURRENTLY WORKING ON AND FURTHER
OPTIMIZING SAMPLE PREPARATION
METHOD TO REDUCE NUMBER OF USER
STEPS AND INCREASE AMOUNT OF
AVAILABLE DNA FOR AMPLIFICATION.
SOME OPPORTUNITIES TO
COLLABORATE INCLUDE LATERAL FLOW
STRIP DESIGN TO IMPROVE
SENSITIVITY AND REAGENTS TO
IMPROVE SHELF LIFE OF THE TEST.
WE COULD USE COLLABORATION AND
TRAINING TO BUILD CAPACITY.
THANK YOU.
[APPLAUSE]
>> AND NEAR-INFRARED IMAGING TO
DIAGNOSE NERVE INJURIES.
>> I'M NOT SAMMY, HE COULD NOT
MAKE IT.
WE'RE A TEAM OF CLINICIANS AND
RESEARCHERS AT JOHNS HOPKINS
FOCUSING ON IMAGING DEVELOPING
THE FIRST AGENT TO IDENTIFY
NERVE REGENERATION AND DECIDE
INTRAOPERATIVE MANAGEMENT OF
NERVE INJURIES.
NERVE INJURIES LEAD TO CHRONIC
DISABILITY, PARALYSIS, PAIN.
THE MAINSTAY OF THERAPY IS
SURGICAL MANAGEMENT.
BUT UNFORTUNATELY OUR ABILITY TO
RESTORE FUNCTION IS HAMSTRUNG BY
INABILITY TO ASSESS EXACT
SEVERITY OF NERVE INJURIES, NO
TECHNOLOGY CAN VISUALIZE
LOCATION OF NERVE REGENERATION,
CRITICAL INFORMATION FOR
SURGEONS TO UNDERSTAND WHEN,
WHERE, HOW TO BEST INTERVENE.
SO AT PRESENT WE'RE ESSENTIALLY
ALMOST IN THE STONE AGES, MAKING
VERY CRITICAL CARE DECISIONS,
HOW NERVES LOOK AND FEEL.
THIS TECHNOLOGY, MACROPHAGES
INVADE NERVES AND SO BY
VISUALIZING MACROPHAGES IN THE
NERVE WHICH REMAIN, AGAIN, IN
DEGENERATIVE PORTIONS BUT EFFLUX
WE CAN GET INVERSE IMAGE AND
THIS ALLOWS US TO BETTER
UNDERSTAND WHERE THE NERVE IS
INJURED AND WE BELIEVE CAN
ENHANCE MANAGEMENT OF THESE
INJURIES.
SO, IN ORDER TO IMAGE THESE
MACROPHAGES WE'RE USING AN
INVESTIGATIONAL CLINICAL STAGE
NERVE REAGENT tPA 713, IT'S
BEEN TESTED IN CLINICAL STUDIES
BY OUR GROUP AND OTHERS TO
DETECT NEURAL INFLAMMATION IN
THE BRAIN AND PRE-CLINICAL WORK
WE HAVE SHOWN THERE'S HIGH
UPTAKE OF DPA IN INJURED NERVES
IN OUR ANIMAL MODEL AND CONFIRM
TRANSLATABILITY IN HUMANS WE'VE
DONE HISTOLOGIC STUDIES
DEMONSTRATING THAT'S THE
RECEPTOR FOR DPA HIGHLY
EXPRESSED IN DEGENERATIVE
PORTIONS OF HUMAN NERVES.
THIS AS A PET IMAGING AGENT,
IT'S CURRENTLY AVAILABLE TO BE
PURCHASED FOR CLINICAL STUDIES
BUT WE'RE LOOKING FOR DEVELOPING
HIGH CAPACITY cGMP PRODUCTION
OF NEAR-INFRARED VERSION.
NERVE INJURIES AFFECT 200,000
AMERICANS EACH YEAR AND THESE
INJURIES CAN BE SEVERELY
DEBILITATING, PATIENTS ARE
GENERALLY OFF WORK FOR SIX
MONTHS, AROUND A THIRD OF THEM
RECEIVE LONG-TERM DISABILITY
PAYMENTS.
WE'RE GEARING UP BASICALLY FOR
FIRST CLINICAL STUDIES.
WE SEEK ASSISTANCE WITH
COLLABORATORS AND TO MARKETING
STRATEGY COMMERCIALIZATION AS
WELL AS FUNDING SUPPORT TO BRING
TO THE NEXT STEPS.
I'D LIKE TO ACKNOWLEDGE HELP
FROM JOHNS HOPKINS AS WELL AS
BLUEPRINT MED TECH PILOT PROGRAM
WITH SUPPORT AND ALSO JUST
GUIDANCE.
THANK YOU VERY MUCH.
[APPLAUSE]
>> THANK YOU.
LAST BUT NOT LEAST MICHAEL WITH
BRAINSTEM BIOMETRICS, CEO AND SO
FOUNDER, REGULATING DRUG DOSING
IN ICU PATIENTS.
>> THANK YOU, SUSAN.
I'M MICHAEL BOLTON, CEO AND
FOUNDER.
OUR PRIMARY MISSION TO REDUCE
UNNECESSARY OVERMEDICATION IN
CRITICAL CARE PATIENTS.
OVERMEDICATION IS ESPECIALLY
DANGEROUS WITH SEDATIVES AND
ANALGESICS, A PROBLEM IN
MEDICINE WORLDWIDE.
AND UNFORTUNATELY THERE'S NO
SOLUTION.
SO IT'S ONE OF THOSE THINGS WE
ACCEPT AS A SIDE EFFECT OF
SAVING YOUR LIFE, YOU MAY HAVE A
LITTLE BIT OVERSEDATION BUT
WE'LL TAKE ONE FOR THE OTHER.
OUR PRODUCT IS SIMPLE EYE PATCH
TO KNOW LEVEL OF EFFECT ON THE
PATIENT THAT'S ACTING DEEP
INSIDE THE BRAINSTEM WHICH IS
THE AREA THAT IS THE ACTING SITE
FOR THOSE DRUGS AND WE USE THAT
FEEDBACK TO REGULATE DOSING IN A
MUCH SMARTER WAY.
PATIENTS IN THE ICU ARE
OVERSEDATED BY 50% OF THE TIME
THEY GET POOR SLEEP, DELIRIOUS,
LOSE CIRCADIAN RHYTHM, ONE OF
THE MOST POPULAR PUBLICATIONS
WHERE NIGHT TURNS TO DAY.
IT'S A COMPLEX PROBLEM.
ONE ISSUE IS POLYPHARMACY.
WE GIVE SEDATIVES ON TOP OF
OPIOIDS, CREATING UNPREDICTABLE
BEHAVIOR.
WHEN TODAY'S STANDARD OF CARE IN
EVERY HOSPITAL IN THE WORLDS FOR
DETERMINING THE LEVEL OF
SEDATION OF THESE DRUGS IS
STIMULUS RESPONSE EXAM, I MIGHT
SAYS OPEN YOUR EYES IF YOU CAN
FEEL ME POKING YOU.
WE DO THAT TWICE A DAY.
SO THE CURRENT STANDARD OF CARE
IS VERY POOR AND IN PARTICULAR
WHEN YOU GET A PATIENT BELOW THE
LEVEL OF RESPONSIVENESS, AND WE
GET NO INFORMATION, OFTENTIMES
WE BRING THEM INTO A MEDICAL
COMA WITH SEDATIVES NOT KNOWING
BECAUSE WE HAVE NO RESPONSIVE
INFORMATION WHATSOEVER.
THAT'S REALLY, REALLY BAD FOR
YOUR HEALTH.
I WOULD SAY THAT OUR INNOVATIVE
BRAINSTEM MONITORING SYSTEM WE
MEASURE A NANOSCALE NEUROTREMOR.
EYE PRESENT IN AUTISM OF US.
MANIFESTING IF A MOVEMENT.
EYEBALLS RIGHT NOW IN A SMALL
ONE NANOMETER SCALE.
THAT SIGNAL ORIGINATES IN THE
AROUSAL CENTER.
SO WE'VE SHOWN IN A NUMBER EVER
STUDIES INCLUDING 225 PATIENTS,
HIGH SENSITIVITY AND SPECIFICITY
WHEN YOU'RE ABLE TO
NON-INVASIVELY MONITOR IT'S A
PROXY FOR LEVEL OF EFFECT ON
THOSE DRUGS.
THE SENSOR IS A VERY SAFE LOW
COST ADHESIVE STRIP, MEASURES
THE VIBRATION THROUGH THE EYELID
AND CAN BE DONE WITH EYES OPEN
OR CLOSED, WE DISPLAY THAT TRACE
PROPORTIONAL TO DRUG EFFECT,
THIS DIRECTLY COMPLEMENTS
EXISTING WORKFLOW IN THE ICU,
WHERE YEAHS TODAY ROUNDS MIGHT
BE TWICE AS DAY WITH A PHYSICAL
EXAM AND WE WOULD ADJUST THE
DRUG BASED ON OTHER PARAMETERS
TWICE A DAY WE CAN NOW DO THAT
IMMEDIATELY AT THE BEDSIDE AT
THE POINT OF CARE IN A
CONTINUOUS BASIS.
SO THE -- I LOST THE -- THE
COMPANY ITSELF WE'VE GOT A
NUMBER OF INITIAL CLINICAL
VALIDATION STUDIES, HIGH
SENSITIVITY AND SPECIFICITY,
PRELIMINARY FDA CLEARANCE ON
DEVICE WE OWN, A HUGE PATENT
PORTFOLIO SO EVERYTHING IS
DE-RISKED, WE'RE IN A TWO
MILLION FUNDING ROUND SAND WOULD
INVITE YOU TO SUPPORT OUR
MISSION TO REDUCE OVERMEDICATION
AND HELP CRITICAL CARE PATIENTS.
HAPPY TO TALK TO YOU UPSTAIRS
AFTERWARD ABOUT THE TECHNOLOGY.
DEVICE.
THANK YOU.
[APPLAUSE]
THAT CONCLUDES OUR
PRESENTATION TODAY FOR RAPID
PITCHES.
JOIN US UP STAIRS FOR
CONVERSATION TO FURTHER DISCUSS.