I'M DR. JULIE PANEPINTO AT THE
NHLBI.
IT'S MY PLEASURE TO OPEN THE
2022 NHLBI AND OASH SYMPOSIUM.
THE PLANNING AND ORGANIZING OF
THIS HAS BEEN SIGNIFICANT AND I
WANT TO EXTEND MY THANKS AND
APPRECIATION TO THE CO-CHAIRS OF
THE SYMPOSIUM, DOCTORS CUSTER
AND ROUBINIAN, AND TO THE
PROGRAM STAFF FROM OASH AND
NHLBI FOR THEIR HARD WORK.
IT'S WONDERFUL TO NOW HAVE ALL
OF YOU JOINED WITH US TODAY TO
BEGIN THE WORK OF IDENTIFYING
RESEARCH PRIORITIES RELEVANT TO
BLOOD TRANSFUSION MEDICINE.
FOCUSED ON THESE THREE AREAS OF
IMPORTANCE.
INCREASING AND DIVERSIFYING THE
POOL, IDENTIFYING WHICH BLOOD
PRODUCTS FROM WHICH DONORS WOULD
BEST MATCH THE NEEDS OF SPECIFIC
RECIPIENT POPULATIONS, AND
HELPING ENSURE SAFE AND
EFFECTIVE TRANSFUSION
STRATEGIES.
TODAY WE'RE FORTUNATE AND
HONORED TO HAVE ADMIRAL RACHEL
LEVINE WHO SERVES AS 17th
ASSISTANT SECRETARY FOR HEALTH,
UNITED STATES DEPARTMENT OF
HEALTH AND HUMAN SERVICES, AND
HEAD OF THE U.S. PUBLIC HEALTH
SERVICE COMMISSIONED CORPS,
PROVIDE OPENING REMARKS BY
VIDEOCAST FOR THE STATE OF THE
SCIENCE AND TRANSFUSION MEDICINE
SYMPOSIUM.
ADMIRAL LEVINE IS A STRONG
ADVOCATE, WORKING TO HELP OUR
NATION OVERCOME THE COVID-19
PANDEMIC AND BUILD A STRONGER
FOUNDATION FOR HEALTHIER FUTURE.
ONE IN WHICH EVERY AMERICAN CAN
ATTAIN THEIR FULL HEALTH
POTENTIAL.
ADMIRAL LEVINE'S CAREER FIRST AS
A PHYSICIAN IN ACADEMIC MEDICINE
FOCUSED ON INTERSECTION BETWEEN
HEALTH AND PHYSICAL HEALTH
TREATING CHILDREN, ADOLESCENTS,
YOUNG ADULTS, THEN AS
PENNSYLVANIA'S PHYSICIAN
GENERAL, LATER AS PENNSYLVANIA'S
SECRETARY OF HEALTH, SHE
ADDRESSED COVID-19, OPIOID
CRISIS, BEHAVIORAL HEALTH, OTHER
PUBLIC HEALTH CHALLENGES.
HERE ARE DR. LEVINE'S OPENING
REMARKS.
>> THANK YOU, DR. PANEPINTO.
GOOD MORNING.
FIRST I WOULD LIKE TO THANK YOU
FOR YOUR INVITATION TODAY TO
ADDRESS THIS VERY EXCITING
SYMPOSIUM.
AS THE UNITED STATES DEPARTMENT
OF HEALTH AND HUMAN SERVICES
BLOOD SAFETY DIRECTOR -- OF THE
BLOOD, ORGAN SENIOR EXECUTIVE
COUNCIL I REMAIN ENGAGED IN
ISSUES AFFECTING THE BLOOD
SUPPLY AND AM DEEPLY INTERESTED
IN WAYS TO IMPROVE OUTCOMES FOR
PATIENTS WHO REQUIRE BLOOD AND
BLOOD PRODUCTS.
BEYOND MY CURRENT ROLES, I
ADDRESS YOU TODAY AS A PHYSICIAN
AND PEDIATRICIAN, HAVING SEEN
THE ROLE BLOOD CAN MAKE IN
PATIENTS WHO EXPERIENCED TRAUMA,
CANCER, HEMORRHAGE,
HEMOGLOBINOPATHIES AND OTHER
CONDITIONS, IT IS LIFE SAVING.
THERE ARE SO MANY INTERESTING
PROJECTS THAT DESERVE YOUR
ATTENTION AND PRIORITIZATION.
FROM WAYS TO ENSURE A DIVERSE
AND ROBUST BLOOD DONOR
POPULATION TO EVALUATING THE
TRANSFUSION AND TRANSMISSION
POTENTIAL OF EMERGING
INCORPORATE FECKS, --
INFECTION, TO IMPLEMENTING
TRANSFUSION PRECISION MEDICINE
APPROACHES, TO REDUCING HEALTH
DISPARITIES IN PEOPLE WHO NEED
TRANSFUSIONS.
REMEMBER, WHAT MAY BE AN IDEA
TODAY COULD BE A TRANSFORMATIVE
INTERVENTION TOMORROW.
IT'S MORE IMPORTANT THAN EVER TO
INVEST IN WAYS TO DRIVE RESEARCH
TO IMPROVE OUTCOMES FOR PATIENTS
WE CARE FOR SPECIAL ESPECIALLY
WHEN SUPPLIES ARE NOT
GUARANTEED.
I KNOW THAT NOT EVERYONE WHO
WOULD LIKE TO DONATE BLOOD IS
ELIGIBLE TO DONATE.
I RECOGNIZE THE HISTORY
ASSOCIATED WITH RESTRICTIONS ON
BLOOD DONATION, AND I NEED TO
USE SCIENCE AND EVIDENCE TO MOVE
FORWARD.
UP UNTIL THIS SUMMER, DAYS OF
BLOOD SUPPLY ON HAND FOR MOST OF
THE COVID-19 PANDEMIC WAS VERY
LOW.
VOLUNTARY BLOOD DONATION HAS
BEEN ON THE DECLINE FOR THE PAST
DECADE ACTUALLY.
AS YOU ALL KNOW, COMPOUNDING THE
PROBLEM, THE COVID-19 PANDEMIC
BROUGHT TO FORE EXTRAORDINARY
CHANCE, THE COLLECTION AND
UTILIZATION OF BLOOD AND BLOOD
PRODUCTS.
TO ENCOURAGE BLOOD AND PLASMA
DONATION EARLIER THIS MONTH MY
OFFICE, OFFICE OF THE ASSISTANT
SECRETARY FOR HEALTH, LAUNCHED
THE NATIONAL BLOOD AND PLASMA
DONATION AWARENESS CAMPAIGN.
IN MARCH 2020 CONGRESS PASSED
THE CORONAVIRUS ACT, THE CARES
ACT, TO PROVIDE COVID-19
PANDEMIC RELIEF TO MILLIONS OF
AMERICANS, INCLUDED IN THAT
IMPORTANT LEGISLATION IS THE
NATIONAL BLOOD AND PLASMA
AWARENESS CAMPAIGN DESIGNED TO
ADDRESS THE DECLINES IN BLOOD
AND PLASMA DONATION WITNESSED
DURING THE EARLY WEEKS AND
MONTHS OF THE PANDEMIC.
NOW, WHILE THERE IS NO DOUBT
THAT THE COVID-19 PANDEMIC
CAUSED IMMENSE DISRUPTION, THE
CHALLENGES THAT WE FACE TODAY
ARE NOT FROM COVID-19 ALONE.
THAT IS WHY IT IS CRITICAL THAT
THE CAMPAIGN SOUGHT TO ADDRESS
BOTH IMMEDIATE AND LONG-TERM
NEEDS, RELATED TO DONATION,
INCLUDING DONOR EDUCATION AND
DONOR OUTREACH.
IMPORTANTLY, THIS CAMPAIGN ALSO
PROVIDES AN OPPORTUNITY TO REACH
UNDERSERVED COMMUNITIES, BECAUSE
WE KNOW PATIENTS WHO RECEIVE
BLOOD FROM DONORS OF SIMILAR
RACIAL BACKGROUNDS EXPERIENCE
BETTER OUTCOMES.
IN IT, WE HIGHLIGHT HEATHER, A
BLACK WOMAN BATTLING SICKLE
CELL DISEASE AND AIRABELLE, IN
NEED OF PLASMA.
INCLUDING DIVERSITY, EQUITY, AND
INCLUSION INTO THIS SYMPOSIUM'S
RESEARCH PRIORITIES.
I'M CONFIDENT EXPERTS WILL
PROVIDE INSIGHTFUL INFORMATION
AND HELP GUIDE A FRUITFUL
DISCUSSION OF THE RESEARCH
PRIORITIES THAT WILL HELP ENSURE
THE SAFETY AND AVAILABILITY OF
THE BLOOD SUPPLY AS WELL AS THE
SAFETY AND EFFECTIVENESS OF
TRANSFUSION THERAPIES.
I LOOK FORWARD TO THE FUTURE OF
TRANSFUSION MEDICINE AND THE
ADVANCEMENTS THAT CAN BE MADE
POSSIBLE BY THE DECISIONS MADE
TODAY.
I WILL NOW TURN TO THE CHAIRS OF
THE SYMPOSIUM AND WISH YOU THE
BEST OF LUCK IN YOUR CONTINUED
RESEARCH.
THANK YOU.
>> ALL RIGHT.
THANK YOU.
WELCOME AND THANK YOU FOR
PARTICIPATING IN THE 2022 STATE
OF THE SCIENCE AND TRANSFUSION
MEDICINE SYMPOSIUM.
WE WOULD LIKE TO THANK ADMIRAL
LEVINE AND DR. PANEPINTO FOR THE
OPENING STATEMENTS.
THANK YOU FOR TAKING TIME TO
OPEN THIS SYMPOSIUM.
NEXT I WOULD LIKE TO THANK THE
NATIONAL HEART, LUNG AND BLOOD
INSTITUTE DIVISION OF BLOOD
RESOURCE, BLOOD EPIDEMIOLOGY AND
CLINICAL THERAPEUTICS BRANCH AND
DEPARTMENT OF HEALTH AND HUMAN
SERVICES, OFFICE FOR ASSISTANT
SECRETARY FOR HEALTH, FOR BEING
ASKED TO SERVE AS CO-CHAIR ALONG
WITH DR. ROUBINIAN, THANK YOU TO
DR. GLEN, HALU, XI R,
MR. BERGER, AND DR. MARTIN, A
MEMBER OF THE ORGANIZING
COMMITTEE FOR STATE OF THE
SCIENCE AND TRANSFUSION
MEDICINE.
IT'S BEEN A LONG PROCESS TO GET
TO THE OPENING OF THIS SYMPOSIUM
AND THE ACTIVITIES OF THE NAGS
TWO DAYS, FIRST PLANNED TO BE
HELD ON THE NIH CAMPUS IN
BETHESDA IN 2020.
STARTING IN 2019, THE ORGANIZING
COMMITTEE BEGAN THE PROCESS OF
DEFINING THE SYMPOSIUM AREAS OF
FOCUS AND EXPECTED RESULTS.
THIS BEGAN WITH IDENTIFYING SIX
THEMES OR TOPICS OF RELEVANCE TO
TRANSFUSION MEDICINE BY THE
ORGANIZING COMMITTEE INCLUDING A
DEBATE AS TO WHETHER WE ACHIEVED
THE OVERALL OBJECTIVES OF
DEFINING RESEARCH THEMES BY
WHICH TO ORGANIZE THE SYMPOSIUM.
I BELIEVE WE HAVE.
THAT WAS JUST TRULY THE
BEGINNING.
IDENTIFICATION OF THE LEADERS OF
EACH OF THOSE TEAMS AND TOPICS,
THE FORMATION OF WORKING GROUPS,
TO GUIDE US THROUGH THINKING
THROUGH THE RESEARCH PRIORITIES
AND DEFINING PRIORITIES WAS THE
NEXT MOST IMPORTANT STEP.
WE THEN HIT PAUSE FOR TWO YEARS,
ALMOST TWO YEARS, AS WE ALL
NOW.
NOW LATE IN 2021, WE ESSENTIALLY
RECONVENED AND ASKED THOSE
WORKING GROUP CHAIRS TO DEVELOP
WORKING GROUPS ULTIMATELY GOING
TO DEFINE RESEARCH PRIORITIES
PRESENTED TODAY AND TOMORROW.
EACH OF THE WORKING GROUPS HAS
SIX TO EIGHT MONTHS TO DISCUSS
THEIR RESEARCH PRIORITIES AND
DEFINE THEM, THAT WILL BE
PRESENTED TODAY.
THE WORKING GROUP MEMBERS ARE AN
IMPRESSIVE CROSS-SECTION OF
REALLY DIVERSE RESEARCH
EXPERTISE THAT I THINK ARE GOING
TO BE CRITICAL FOR US AS WE
REALLY EXPAND OUR THOUGHTS ABOUT
WHAT ARE THE RESEARCH PRIORITIES
IN BLOOD-RELATED RESEARCH IN THE
U.S.
ALSO, OF COURSE, HAVING
SYMPOSIUM IS JUST THE FIRST
STEP.
WE WILL HAVE THE PROCESS FOR
FORMALIZING THESE PRIORITIES
THROUGH PUBLICATIONS.
BUT FOR NOW, THE NEXT STEP IS
FOR ME TO INTRODUCE MY CO-CHAIR,
DR. NAREG ROUBINIAN TO LEAD US
THROUGH HOUSEKEEPING.
WELCOME.
>> THANK YOU, BRIAN, FOR THE
INTRODUCTION.
I'M NAREG ROUBINIAN, AND I'M
PLEASED TO WELCOME EVERY ONE.
IT'S BEEN AN HONOR TO WORK WITH
THE ORGANIZING COMMITTEE AND
WONDERFUL COLLEAGUES CO-CHAIRING
AND PARTICIPATING IN THE SIX
WORKING GROUPS.
AND WE'RE LOOKING FORWARD TO
SHARING THE DRAFT RESEARCH
PRIORITIES AND HEARING AND
DISCUSSING YOUR COMMENTS AND
QUESTIONS.
TODAY YOU'LL HEAR PRESENTATIONS
OF RESEARCH PRIORITIES FROM
THREE OF THE SIX WORKING GROUPS,
INCLUDING FOCUS ON BLOOD DONORS
AND BLOOD SUPPLY, OPTIMIZING
TRANSFUSION OUTCOMES, AND
EMERGING INFECTIONS.
KEY COMPONENT IS DIRECT
ENGAGEMENT WITH SCIENTIFIC
COMMUNITY, IN ORDER TO FURTHER
REFINE RESEARCH PRIORITIES AND
INCORPORATE YOUR PERSPECTIVES IN
THIS PRIORITIZATION PROCESS.
IT IS WORTH NOTING THAT THE
SYMPOSIUM IS BEING RECORDED,
YOU'LL HAVE THE OPPORTUNITY TO
REVIEW THESE PRESENTATIONS AND
DISCUSSIONS, AND WE ASK THAT
DURING THE PRESENTATIONS THAT
YOUR MICROPHONES REMAIN MUTED.
WE DO ASK THAT YOU USE THE ZOOM
CHAT BOX TO ASK QUESTIONS OR
MAKE COMMENTS DURING THE
PRESENTATIONS.
THESE QUESTIONS AND COMMENTS
HAVE BEEN COLLATED AND SHARED
FOR DISCUSSION DURING SUBSEQUENT
BREAKOUT SESSIONS.
FOLLOWING THE PRESENTATIONS BY
THE THREE WORKING GROUPS TODAY,
WE'LL HAVE A LUNCH BREAK, ASK
YOU TO RETURN TO PARTICIPATE IN
ONE OF THE THREE SIMULTANEOUSLY
OCCURRING WORKING GROUP BREAKOUT
SESSIONS, AND YOU WILL AGAIN
HAVE THE OPPORTUNITY TO USE THE
CHAT BOX TO ASK QUESTIONS, MAKE
COMMENTS, RAISE YOUR HAND
THROUGH THE ZOOM PORTAL, TO BE
CALLED ON TO SPEAK.
THE WORKING GROUP CO-CHAIRS WILL
ADDRESS THE COMMENTS AND CALL ON
ATTENDEES WHO RAISED THEIR
HANDS.
WE'RE ALSO PLEASED TO HAVE THREE
KEYNOTE SPEAKERS WHO WILL IS
SHARE PERSPECTIVES ON THE STATE
OF THE SCIENCE IN TRANSFUSION
MEDICINE.
IT'S MY PRIVILEGE TO INTRODUCE
DR. STEPHEN SPITALNIK, A
PROFESSOR OF PATHOLOGY AND CELL
BIOLOGY, VICE CHAIR OF
LABORATORY MEDICINE, COLUMBIA
UNIVERSITY, RECOGNIZED FOR
OUTSTANDING LEADERSHIP,
RESEARCH, MENTOR SHIP IN
TRANSFUSION MEDICINE, A LEADER
IN CELL BIOLOGY.
DR. SPITALNIK HAS HEALTH
NUMEROUS COMMITTEE AND
LEADERSHIP POSITIONS, INCLUDING
STUDY SECTIONS, CO-CHAIRING THE
MOST RECENT STATE OF THE SCIENCE
IN TRANSFUSION MEDICINE
SYMPOSIUM IN 2015.
DR. SPITALNIK, I WELCOME YOU.
>> THANK YOU FOR INVITING ME TO
SPEAK TO YOU TODAY, IT'S A
PLEASURE AND HONOR TO DO SO AND
I APPRECIATE IT.
SO, I THOUGHT -- I TURNED 70
YEARS OLD THIS YEAR, I'VE BEEN
AT MULTIPLE STATE OF THE SCIENCE
SYMPOSIUM IN THE PAST AND
THOUGHT I WOULD GIVE YOU SOME
REFLECTIONS ON THE PAST AND SOME
THOUGHTS ON THE FUTURE.
THIS IS NOT RELATED TO MY WORK
BUT IT IS SORT OF MY PERSPECTIVE
ON TRANSFUSION MEDICINE AS A
WHOLE.
NEXT SLIDE PLEASE.
SO, THESE ARE MY DISCLOSURES.
I DON'T THINK THAT ANY OF THEM
ARE REEL VICE-PRESIDENT TO WHAT
I'M GOING TO TALK TO YOU ABOUT
TODAY.
THANKS.
NEXT SLIDE PLEASE.
SO, I THINK WE'RE AMONGST
OURSELVES IN THE TRANSFUSION
MEDICINE COMMUNITY AND CAN BE
HONEST WHICH IS WE'RE
CONTROLLING INDIVIDUALS.
WE HAVE SOPs FOR EVERYTHING,
EVEN SOPs ON HOW TO WRITE AN
SOP.
I THINK IF WE WERE BEING HONEST
WITH OURSELVES, WE WOULD ADMIT
THAT WE WOULD LIKE TO MANIPULATE
THE COMPOSITION OF BLOOD WITH
COMPLETE CONTROL AND WITHOUT ANY
ADVERSE CONSEQUENCES.
OF COURSE, THAT'S NOT POSSIBLE,
AT LEAST NOT POSSIBLE NOW, BUT I
REALLY THINK THAT'S WHO WE ARE.
NEXT SLIDE PLEASE.
THANK YOU.
HOW DO WE DO THIS?
WE DO THIS BY TRANSFUSING
PRODUCTS, CLASSICAL PRODUCTS, WE
DO THIS BY INFUSING PURIFIED OR
RECOMBINANT PROTEINS, CAN
PRESCRIBE DRUGS TO MANIPULATE
THE BLOOD, CIRCULATING BLOOD,
AND WE ALSO DO THIS INTERESTING
THING OF APHERESIS WHERE WE CAN
REMOVE, IF YOU WILL, EVIL HUMORS
AND REPLACE THEM WITH GOOD
HUMORS, WHETHER CELLS OR SOLUTES
IN THE PLASMA.
AS AN EXAMPLE OF WHAT WE WOULD
LIKE TO DO IS WE WOULD LIKE TO
TRANSFUSE ANY UNIT OF BLOOD
CELLS OFF THE SHELF AND GIVE IT
INTO ANY RECIPIENT, AND DO THIS
BY ACHIEVING WHATEVER OUR
DESIRED EFFECT IS, LIKE
NORMALIZING HEMOGLOBIN OR
HEMATOCRIT AND WITHOUT ANY
ADVERSE CONSEQUENCES, NO
TRANSFUSION REACTIONS, NO
TRANSFUSION TRANSMITTED
DISEASES, ET CETERA.
AGAIN, I DON'T THINK THIS IS
POSSIBLE YET BUT I THINK WE'RE
GETTING CLOSER AND CERTAINLY MY
PERSPECTIVE OVER THE LAST 40
YEARS OR SO IN THIS FIELD IS
THAT WE'RE GETTING A LOT CLOSER.
NEXT SLIDE PLEASE.
SO, I WOULD ARGUE THAT ONE OF
THE CENTRAL THESIS OF THIS, IF
WE'RE GOING TO MANIPULATE
COMPOSITION OF BLOOD, FOR WHAT
WE CONSIDER TO BE CLASSICAL
BLOOD PRODUCTS THAT WE SHOULD
THINK OF THEM AS
PHARMACEUTICALS.
NEXT SLIDE PLEASE.
AND SO THE GOAL WOULD BE TO
CHANGE OR EVOLVE A COMPLEX
BIOLOGICAL PRODUCT INTO A PURE
DRUG.
NEXT SLIDE.
SO, THE CLASSICAL EXAMPLE I USE,
I GET HEADACHES OFTEN, A FORMER
HEAD OF TRANSFUSION MEDICINE AND
LABORATORY MEDICINE, IS IF YOU
BREW YOURSELF A CUP OF WHITE
WILLOW BARK TEA, ON THE LEFT,
YOUR HEADACHE WILL CERTAINLY GO
AWAY.
THE MEDICAL MODEL, HOWEVER, IS
TO FIGURE OUT WHAT IS THE ACTIVE
INGREDIENT OR INGREDIENTS IN
WHITE WILLOW BARK TEA, AND THEN
MAKE THAT INTO A DRUG LIKE ON
THE RIGHT, WHICH IS ASPIRIN,
WHICH THEN YOU CAN CONTROL THE
DOSAGE AND PURITY AND THINGS
LIKE THAT.
IN FACT, NEXT SLIDE PLEASE, THE
FDA HAS DEFINED THEIR MEDICAL
MODEL OF A PHARMACEUTICAL THAT
INCLUDES THINGS LIKE WE WOULD
ALL THINK ABOUT, WHAT ARE THE
ACTIVE INGREDIENTS, HOW PURE ARE
THEY, WHAT ARE THE OTHER THINGS
THAT ARE IN THERE, HOW LONG CAN
YOU KEEP IT ON THE SHELF, WHAT
DOSE SHOULD YOU USE, HOW SHOULD
YOU ADMINISTER IT, WHAT ARE THE
INDICATIONS, ADVERSE OUTCOMES,
ET CETERA, ET CETERA.
SO, I THINK THIS MAKES A LOT OF
SENSE WHEN YOU THINK IN THE
CONTEXT OF ASPIRIN OR WHATEVER,
WHAT OTHER TYPE OF THERAPEUTIC
DRUG YOU MIGHT THINK OF.
NEXT SLIDE PLEASE.
HOWEVER, IN THE CONTEXT OF BLOOD
PRODUCTS, I THINK IT ACTUALLY
MAKES A LOT OF SENSE.
NEXT SLIDE PLEASE.
I WOULD ARGUE THAT ALL OF THESE
DEFINITIONS OF A MEDICAL MODEL
OF A PHARMACEUTICAL ARE RELEVANT
TO BLOOD PRODUCTS.
IF YOU'RE GOING TO GIVE, YOU
KNOW, A UNIT OF FRESH FROZEN
PLASMA, WHAT ARE YOU GIVING?
WHAT IS THE ACTIVE INGREDIENT?
HOW PURE IS IT?
WHAT ELSE IS IN THERE?
HOW LONG IS IT STABLE?
HOW MUCH SHOULD YOU GIVE?
WHAT IS THE INDICATION, CLINICAL
EFFECTIVENESS, ADVERSE OUTCOMES.
ALL THESE THINGS RELATE TO THE
WAY WE PRACTICE TRANSFUSION
MEDICINE AND THINK ABOUT HOW TO
IMPROVE THE PRACTICE OF
TRANSFUSION MEDICINE.
NEXT SLIDE PLEASE.
AND IN FACT, I WOULD ARGUE THAT
WE'VE SUCCEEDED, AT LEAST IN
SOME REGARD, IN THIS APPROACH.
AND THE CLASSICAL EXAMPLE I
WOULD USE IS TREATING PATIENTS
WITH HEMOPHILIA A.
WHEN I WAS A RESIDENT IN THE
1970s, IF WE HAD A PATIENT
WITH HEMOPHILIA, ADMITTED WITH A
HEME ARTHROSIS, TREATMENT WOULD
INCLUDE CRYOPRECIPITATE, ON THE
LEFT, WHICH HAS ALL THE ISSUES
AND PROBLEMS OF A COMPLEX
BIOLOGICAL PRODUCT, BUT NOW
TODAY IF A PATIENT WAS ADMITTED
WE GIVE RECOMBINANT FACTOR A
WHERE WE KNOW WHAT WE'RE GOING,
EXACTLY THE DOSE AND HOW PURE
AND EXACTLY WHAT INGREDIENTS
ARE.
NEXT SLIDE PLEASE.
HOWEVER, THIS IS MORE
COMPLICATED TO DO IN SOMETHING
LIKE A RED BLOOD CELL UNIT, TO
MAKE THAT INTO A PURE DRUG.
NEXT SLIDE PLEASE.
HOWEVER, WITH THE ADVENT OF, IF
YOU WILL, BLOOD FARMING, THERE
ARE A LOT OF GROUPS THAT ARE
WORKING ON EITHER MAKING HUMAN
RED BLOOD CELLS FROM STEM CELLS
IN VITRO OR MAKING VESICLES THAT
CONTAIN PURE HEMOGLOBIN OR
CELL-FREE HEMOGLOBIN, NONE HAVE
COME TO THE STATUS OF BEING USED
CLINICALLY BUT PERHAPS IN THE
NEXT NUMBER OF YEARS THIS WILL
HAPPEN, WE WILL SEE.
NEXT SLIDE PLEASE.
SO, I WOULD LIKE TO SWITCH TO
WHY WE'RE HERE TODAY WHICH IS TO
MAKE TRANSFUSION MEDICINE
BETTER, MAKE TRANSFUSIONS SAFER,
COME UP WITH NEW WAYS OF
TREATING PATIENTS.
AND I'LL START WITH BISMARK,
FELT TO BE A CONSUMMATE
POLITICIAN WHO HELPED UNIFY
GERMANY INTO A SINGLE COUNTRY IN
THE 19th CENTURY.
NEXT SLIDE PLEASE.
AND ONE OF HIS STATEMENTS, AS
THE CONSUMMATE POLITICIAN, IS
THAT POLITICS IS THE ART OF THE
POSSIBLE.
NEXT SLIDE PLEASE.
HOWEVER, HE DIDN'T SAY THAT.
HE SAID THIS.
BUT SINCE I DON'T SPEAK GERMAN
I'M NOT GOING TO MAKE AN ATTEMPT
TO READ THIS TO YOU.
RATHER, NEXT SLIDE, I'LL REMIND
YOU OF THE ENGLISH TRANSLATION,
THAT POLITICS IS THE ART OF THE
POSSIBLE.
NEXT SLIDE PLEASE.
THEN SIR PETER MEDAWAR WHO WON A
NOBEL PRIZE FOR WORK IN
IMMUNOLOGY TOOK THIS TO ANOTHER
STEP.
NEXT SLIDE PLEASE.
HE SAID THAT SCIENCE IS THE ART
OF THE SOLUBLE.
IN AMERICA WE MIGHT SAY ART OF
THE SOLVABLE.
IF YOU CAN'T SOLVE A SCIENTIFIC
PROBLEM, YOU CAN'T DO SCIENCE.
YOU CAN COME TO YOUR OWN
DECISIONS AS TO WHAT EXAMPLES
YOU WOULD USE FOR THAT.
NEXT SLIDE PLEASE.
I THINK FOR TODAY, SINCE WE'RE
TALKING ABOUT THE NIH AND FUTURE
OF NIH FUNDING, I WOULD ARGUE
THAT SCIENCE IS THE ART OF THE
FUNDABLE.
EVEN IF YOU HAVE A PROBLEM THAT
IS SOLVABLE, IF YOU'RE NOT
FUNDED THEN YOU CAN'T SOLVE IT.
NEXT SLIDE PLEASE.
I WOULD MAKE THE SIMPLE EQUATION
OF NO DOLLARS, NO SCIENCE.
NEXT SLIDE PLEASE.
SO, WHERE DO THESE DOLLARS COME
FROM TO DO SCIENCE?
NEXT SLIDE PLEASE.
I DON'T HAVE CONFLICTS WITH ANY
OF THE ORGANIZATIONS I'VE LISTED
HERE BUT THE MONEY CAN COME FROM
INDUSTRY, WHICH TYPICALLY FUNDS,
IF YOU WILL, IN-HOUSE SCIENCE
ALTHOUGH SOME COMPANIES ALSO
HAVE GRANT PROGRAMS.
IT CAN COME FROM PRIVATE
CHARITIES.
MY FAVORITE IS THE FIRST ONE,
NATIONAL BLOOD FOUNDATION, PART
OF THE ABB.
OR IT CAN COME FROM GOVERNMENT.
IN THE UNITED STATES, THAT WOULD
BE THE NIH, DARPA, THINGS LIKE
THAT.
NEXT SLIDE PLEASE.
THERE HAVE BEEN TIMES IN MY OWN
CAREER WHERE I WAS DEPRESSED AT
THE ABILITY TO ATTRACT FUNDING
TO DO SCIENCE.
AND EVEN CONSIDERED THE
POSSIBILITY OF HAVING A BAKE
SALE IN THE LOBBY OF OUR
RESEARCH BUILDING, BUT
FORTUNATELY NEVER HAD TO GO THAT
FAR ALTHOUGH WE GOT CLOSE.
NEXT SLIDE PLEASE.
WHO IS THE LARGEST SUPPORTER OF
MEDICAL RESEARCH IN THE UNITED
STATES?
NEXT SLIDE.
SOME PEOPLE THINK IT'S BILL AND
MELINDA GATES, AND THEY HAVE
BEEN INCREDIBLY GENEROUS WITH
THEIR FOUNDATION, WHICH PROVIDES
HUNDREDS OF MILLIONS OF DOLLARS
ANNUALLY FOR RESEARCH.
NEXT SLIDE PLEASE.
BUT THEY ARE NOT THE BIGGEST
SUPPORTER OF RESEARCH IN THE
UNITED STATES.
THIS X UNFORTUNATELY RELATES TO
THEIR NOT EVEN BEING MARRIED
ANYMORE, WHICH IS SAD BUT THAT'S
LIFE.
NEXT SLIDE.
SO, THEN IF IT'S NOT THE GATES
FOUNDATION OR SOME OTHER PRIVATE
FOUNDATION WHO IS IT?
NEXT SLIDE PLEASE.
I WOULD ARGUE IT'S ALL OF YOU.
ALL OF THE PEOPLE IN THE UNITED
STATES.
THE U.S. TAXPAYER IS THE BIGGEST
SUPPORTER IN THE UNITED STATES.
HOW DO WE DO THIS?
BY PAYING OUR TAXES.
IT'S DONE THROUGH THE NIH.
THIS IS A PICTURE OF THE CAMPUS
IN BETHESDA, THE INTRAMURAL
PROGRAM, IF YOU WILL.
NEXT SLIDE PLEASE.
BUT FOR THE PURPOSES OF TODAY
AND FOR MOST OF THE PEOPLE IN
THE AUDIENCE, WE'RE MOST
CONCERNED WITH THE EXTRAMURAL
PROGRAM, HOW DOES THE NIH FUND
BIOMEDICAL RESEARCH OUTSIDE OF
BETHESDA?
NEXT SLIDE PLEASE.
SO THE WAY NIH DOES THIS IS BY
PROVIDING GRANTS.
AND AS I'M SURE YOU'RE ALL
AWARE, GETTING AN NIH GRANT IS
VERY DIFFICULT.
THERE'S A HIGH BAR THAT NEEDS TO
BE JUMPED OVER IN ORDER TO GET
FUNDED.
AND THE WAY THESE DECISIONS ARE
MADE OR THE FIRST STEP IN MAKING
THESE DECISIONS IS PEER REVIEW
BY STUDY SECTION.
AND YOU SHOULD REMEMBER, PLEASE,
THAT PEER REVIEW IS A HUMAN
CONSTRUCT.
IT'S PERFORMED BY HUMANS.
AND THEREFORE AS YOU MIGHT
IMAGINE, EVEN THOUGH PART OF
EVERY NIH GRANT YOU NEED TO DEAL
WITH THE CONCEPTS OF RIGOR AND
REPRODUCIBILITY, AND IF YOU
WILL, THE ROBUSTNESS OF THE
RESEARCH YOU'RE PROPOSING I
WOULD ARGUE FROM YEARS OF
EXPERIENCE THAT THE PEER REVIEW
PROGRAM IS NOT A HIGHLY ROBUST
PROGRAM, PARTICULARLY AT THE --
IN THE MIDDLE, AT THE NIH
FUNDING CUTOFF.
SO, FOR PROPOSALS THAT ARE
FANTASTIC, I THINK ROBUSTNESS IS
TERRIFIC.
FOR PROPOSAL THAT ARE REALLY
PRETTY BAD, I THINK THE
ROBUSTNESS IS TERRIFIC.
BUT IN THE MIDDLE, IT'S NOT SO
CLEAR TO ME THAT THE REVIEW IS
ROBUST.
EVERYBODY DOES THEIR BEST, BUT
IT IS A HUMAN CONSTRUCT AND
HUMAN JUDGMENT IS REQUIRED.
SO I THINK THERE'S A STATEMENT
FROM WINSTON CHURCHILL THAT'S
RELEVANT TO THIS, WHICH IS, HE
SAID THAT DEMOCRACY IS THE WORST
FORM OF GOVERNMENT, EXCEPT FOR
ALL OTHERS THAT HAVE BEEN TRIED.
NEXT SLIDE PLEASE.
AND I WOULD ARGUE THAT NIH PEER
REVIEW IS THE WORST FORM OF
PROPOSAL EVALUATION, EXCEPT FOR
ALL OTHERS THAT HAVE BEEN TRIED.
AND SO I THINK THIS IS THE BEST
WE CAN DO AT THE MOMENT.
I THINK IT WORKS EXTREMELY WELL.
BUT IT CAN BE, I'M AWARE,
FRUSTRATING FOR YOU AND IT HAS
BEEN ALSO VERY FRUSTRATING ON
OCCASION FOR ME.
NEXT SLIDE PLEASE.
SO, TODAY AND TOMORROW DURING
THIS STATE OF THE SCIENCE
SYMPOSIUM AS IN PRIOR STATE OF
THE SCIENCE SYMPOSIA, THIS IS AN
INCREDIBLE OPPORTUNITY FOR ALL
OF US.
THE NIH LEADERSHIP AT THE
HIGHEST LEVEL WANTS TO HEAR WHAT
WE HAVE TO SAY.
THEY WOULD LIKE TO KNOW WHAT OUR
OPINIONS ARE REGARDING WHAT ARE
THE BEST OR MOST IMPORTANT
THINGS THAT THEY SHOULD FOCUS
THEIR GRANT PROGRAMS ON FOR
ARGUMENT'S SAKE FOR THE NEXT
FIVE TO SEVEN YEARS, AN
INCREDIBLE OPPORTUNITY FOR US TO
GIVE OUR OPINION AND IT'S
INCREDIBLY IMPORTANT FOR THE
FUTURE OF OUR FIELD BECAUSE WE
HELP -- WE DON'T DIRECT IT BUT
WE HELP THE NIH DECIDE WHERE
FUNDING SHOULD BE DIRECTED.
NEXT SLIDE PLEASE.
SO, WHAT ARE OUR HISTORICAL
ANTECEDENTS FOR THIS?
NEXT SLIDE PLEASE.
SO, I WOULD LIKE TO GIVE YOU MY
PERSONAL OPINION ON WHAT THE TOP
TEN ADVANCES HAVE BEEN IN
TRANSFUSION MEDICINE SINCE 1978.
WHY DID I PICK 1978?
BECAUSE THAT WAS THE YEAR I
STARTED MY RESIDENCY IN ANATOMIC
AND CLINICAL PATHOLOGY.
AND WHY DID I PICK TOP TEN?
BECAUSE, WELL, THAT'S HOW WE
OFTEN THINK ABOUT THIS IS, THE
TOP THEN THIS, THE TOP TEN THAT.
NEXT SLIDE PLEASE.
I COULDN'T LIMIT TO TEN, EVEN
THOUGH I TRIED.
NEXT SLIDE PLEASE.
SO I WOULD LIKE TO PROVIDE MY
OPINION ON WHAT THE TOP TWELVE
ADVANCES HAVE BEEN SINCE I
STARTED RESIDENCY TRAINING IN
THE LATE 1970s.
NEXT SLIDE PLEASE.
THESE ARE THE FIRST SIX.
I DON'T THINK THERE'S GOING TO
BE OF ARGUMENT WITH THE GROUP AS
TO WHETHER THESE RISE TO THE
OCCASION, FIRST FOUR PCR, HCV,
HBV, RECOGNIZED BY NOBEL PRIZES,
THE DISCOVERY OF HBV WAS
RECOGNIZED BY NOBEL PRIZE.
THAT'S GREAT.
THE RESULT OF THAT PARTICULARLY
FOR TRANSFUSION MEDICINE HAS
BEEN ABILITY TO SCREEN THE BLOOD
SUPPLY WHICH IS USEFUL.
WHEN I WAS A RESIDENT, HIV/AIDS
PANDEMIC STARTED, WE HAD NO IDEA
FIRST OF ALL WHETHER IT WAS EVEN
A VIRUS BUT EVEN AFTER THAT WAS
IT TRANSMISSIBLE BY BLOOD, AND
IF SO HOW COULD YOU SCREEN OUT
THE UNITS?
AND ALSO I REMEMBER THAT IN THE
1970s, ABOUT 10% OF THE BLOOD
SUPPLY WAS CONTAMINATED WITH
WHAT WAS THEN CALLED NON-A,
NON-B HEPATITIS, NO WAY OF
IDENTIFYING WHICH UNITS WERE
INFECTIOUS OR NOT.
THIS HAS BEEN A TREMENDOUS
ANSWER I WOULD ARGUE IN TERMS OF
THE SAFETY OF THE BLOOD SUPPLY.
I CAN ALSO TELL YOU THAT IN
1978, THE ONLY BLOOD GROUP
ANTIGENS THAT WE HAD ANY IDEA
WHAT THEIR STRUCTURES WERE, WERE
THE CARBOHYDRATE, ET CETERA, AND
DIDN'T KNOW THE GENES THAT
ENCODED THOSE BLOOD GROUP
ANTIGENS AND HAD NO IDEA WHAT
ANY OF THE PROTEIN BLOOD GROUP
ANTIGENS WERE.
IT'S REMARKABLE NOW 40 YEARS
LATER, 44 YEARS LATER, THAT
REALLY WE KNOW EVERYTHING ABOUT
ALL THE GENES AND STRUCTURES
WITH RARE EXCEPTIONS IN THE
BLOOD GROUPS.
I THINK THIS IS A MAJOR ADVANCE.
NEXT SLIDE.
WE MIGHT HAVE MORE ARGUMENTS
AMONG THE GROUP AS TO WHETHER
THESE ARE THE SICK YOU WOULD
CHOOSE -- SIX YOU WOULD CHOOSE
BUT THESE ARE MY OPINION.
USE OF RECOMBINANT GROWTH
FACTORS LIKE ERYTHROPOETIN,
APHERESIS PARTICULARLY FOR
COLLECTING CELLS LIKE PERIPHERAL
BLOOD, HEMATOPOIETIC STEM CELLS,
LYMPHOCYTES, ET CETERA.
ABILITY TO MANIPULATE THE
GENETICS OF EITHER THE CELLS WE
COLLECT OR PATIENTS THAT NEED TO
BE GENETICICALLY MODIFIED,
VARIOUS IMMUNOSUPPRESSION
METHODS STARTING WITH
LEUKOREDUCTION.
HOW ARE WE DOING?
THAT'S MY OPINION FROM 40 YEARS,
WHAT'S MY OPINION FROM THE LAST
STATE OF THE SCIENCE SYMPOSIUM
IN 2015?
NEXT SLIDE PLEASE.
SO, AT THE END OF THE SYMPOSIUM
THESE WERE SOME MAJOR POINTS,
QUESTIONS INCLUDE WHAT'S IN THE
BAG?
ARE OUR TRANSFUSION TRIGGERS
RELEVANT?
HOW DO WE KNOW IF WHAT WE'RE
DOING ACTUALLY WORKS?
HOW CAN WE MAKE BETTER AND SAFER
PRODUCTS?
HOW CAN WE PROTECT OUR DONORS
BETTER BECAUSE THESE ARE
PRIMARILY THE VAST MAJORITY ARE
VOLUNTEER DONORS WHO DONATE
THEIR TIME AND THEIR BLOOD TO
OUR PURPOSE.
AND ALSO AS SOME OF MY
PEDIATRICIAN FRIENDS WILL
CONTINUE TO REMIND ME THAT
CHILDREN ARE NOT SMALL ADULTS,
NEONATES ARE NOT SMALL CHILDREN.
NEXT SLIDE PLEASE.
SO, IN ORDER TO DO THIS WE ALSO
FELT THERE WERE THINGS WE
NEEDED, THE GROUP FELT THERE
WERE THINGS WE NEEDED.
SO WE NEEDED MORE ROBUST
DATABASES, WE NEEDED MORE
MECHANISTICALLY ORIENTED
RESEARCH.
WE NEEDED TO EDUCATE EACH OTHER,
AND OTHER HEALTH CARE PROVIDERS,
AND ALSO THE LAY PUBLIC.
WE NEEDED A BETTER OF
HEMOSTASIS AND IMPROVE TRAINING
IN TRANSFUSION MEDICINE, THE
TASKS WE SET SEVEN YEARS AGO.
NEXT SLIDE PLEASE.
SO I THINK WE DID WELL.
I THINK IF YOU LOOK AT THE
NUMBERS OF PAPERS THAT HAVE BEEN
PUBLISHED OVER THE LAST SEVEN
YEARS, HOW MANY OF THEM HAVE
ADDRESSED THESE KINDS OF ISSUES
AND THE AMOUNT OF COLLABORATIVE
RESEARCH THAT'S BEEN DONE AND
QUALITY OF THE TALKS AT OUR
NATIONAL AND INTERNATIONAL
MEETINGS, I THINK THE FIELD AS A
WHOLE HAS MADE SIGNIFICANT
ADVANCES OVER THE LAST SEVEN
YEARS AND I THINK THE NIH
FUNDING AND SUPPORT FOR
TRANSFUSION MEDICINE HAS PLAYED
A MAJOR ROLE IN THAT.
HOWEVER, I WOULD ARGUE THAT NONE
OF WHAT I'VE SEEN FROM THE LAST
SEVEN YEARS WOULD FIT THE BILL,
IF YOU WERE GIVING THIS TALK 40
YEARS FROM NOW.
SO, WHAT ARE WE GOING TO DO AS A
FIELD TO MAKE SIGNIFICANT
ADVANCES OVER THE NEXT 40 YEARS
TO MATCH WHAT WAS DONE OVER THE
LAST 40 YEARS?
AND I THINK ONE OF THEM IS TO
HAVE MEETINGS LIKE THIS TO TALK
TO EACH OTHER, ENCOURAGE AND
STIMULATE EACH OTHER, AND THEN I
THINK WE NEED TO AIM HIGH IN
TERMS OF WHAT WE FOCUS ON.
NEXT SLIDE PLEASE.
SO, I BELIEVE, AND I BET THAT
ALL OF YOU BELIEVE, THAT THE
MAJOR WAY OF MAKING SUCH
ADVANCES IS BY DOING RESEARCH.
AND THERE ARE MULTIPLE TYPES OF
RESEARCH.
THERE'S BASIC, IF YOU WILL,
MECHANISTIC BENCH RESEARCH,
CLINICAL OR PATIENT-FACING
RESEARCH, THERE'S TRANSLATIONAL
RESEARCH BRINGING THINGS FROM
THE BENCH TO BEDSIDE.
THERE'S PUBLIC HEALTH RESEARCH
WHICH IS REALLY VERY IMPORTANT
DURING THE COVID PANDEMIC, AND I
FORGOT TO LIST THEM BUT YOU
COULD ALSO CONSIDER RESEARCH IN
EDUCATION, EDUCATIONAL RESEARCH,
AND IMPLEMENTATION RESEARCH AS
DIFFERENT TYPES OF RESEARCH
APPROACHES.
AND I'M OFTEN ASKED, WELL,
WHAT'S THE MOST OR BEST WAY OF
DOING RESEARCH, WHAT IS THE BEST
RESEARCH?
AND I WILL ANSWER THAT WITH A
METAPHOR.
NEXT SLIDE PLEASE.
THIS IS DUKE ELLINGTON, AN
AMAZING PIANIST, ORCHESTRA
LEADER, COMPOSER, ADVOCATE, ET
CETERA.
NEXT SLIDE PLEASE.
AND HE WAS ASKED IN A SNIDE WAY,
WHICH WAS INAPPROPRIATE BUT
OKAY, WHICH IS BETTER, CLASSICAL
MUSIC OR JAZZ?
SINCE HE MADE MOST OF HIS CAREER
IN THE REALM, IF, WILL YOU, OF
JAZZ IT WAS A SNIDE QUESTION
TRYING TO IMPLY HIS MUSIC WASN'T
AS GOOD AS CLASSICAL MUSIC.
HE GAVE A WONDERFUL ANSWER.
NEXT SLIDE.
THANK YOU.
THAT THERE'S SIMPLY TWO KINDS OF
MUSIC.
THERE'S GOOD MUSIC, AND THERE'S
THE OTHER KIND.
AND THAT'S THE ANSWER I GIVE.
I THINK WE SHOULD GIVE WHEN
PEOPLE ASK US ABOUT RESEARCH.
NEXT SLIDE PLEASE.
THAT THERE'S SIMPLY TWO KINDS OF
RESEARCH.
THERE'S GOOD RESEARCH, AND
THERE'S THE OTHER KIND.
NEXT SLIDE PLEASE.
AND SO I WOULD ARGUE THAT NONE
OF THESE APPROACHES IS BETTER
THAN THE OTHER.
IT'S HOW ARE THESE APPROACHES
APPLIED, AND WHAT ARE THE
QUESTIONS BEING ASKED THAT ARE
BEING TRIED TO ANSWER.
THAT REALLY MATTER.
NEXT SLIDE PLEASE.
SO IF THAT'S SO, WHO IS GOING TO
DO THIS RESEARCH IN ANY OF THESE
DIFFERENT AXES OF RESEARCH, IF
YOU WILL.
NEXT SLIDE PLEASE.
WELL, I WOULD ARGUE, AS MANY OF
YOU KNOW I'M BLUNT AND
OUTSPOKEN, I BELIEVE THAT
SERIOUS RESEARCH TRAINING IS
REQUIRED.
I DON'T CARE HOW YOU DO IT,
WHETHER A POSTDOC OR TWO
POSTDOCS OR GET TRAINED ON THE
JOB OR SOMETHING, BUT YOU REALLY
NEED TO SPEND THE TIME AND THE
ENERGY TO GET SERIOUS TRAINING
TO DO SIGNIFICANT RESEARCH, AND
I WOULD ARGUE THAT A ONE-YEAR
CLINICAL FELLOWSHIP IN
TRANSFUSION MEDICINE FOLLOWING A
RESIDENCY TRAINING IN PATHOLOGY,
INTERNAL MEDICINE, WHATEVER, IS
NOT SUFFICIENT TO BE ABLE TO DO
GOOD RESEARCH.
YOU NEED TO DO MORE THAN THAT,
AND THAT SIMPLY HAVING A BOARD
CERTIFICATION IN PATHOLOGY
MEDICINE, PEDIATRICS,
TRANSFUSION MEDICINE IS NOT THE
SAME AS HAVING RESEARCH
EXPERTISE.
I WOULD URGE YOU, THE PEOPLE YOU
TRAIN AND INFLUENCE, TO
INFLUENCE THEM TO GET SERIOUS
RESEARCH TRAINING.
NEXT SLIDE PLEASE.
AND SO WHO IS GOING TO DO IT?
WE NEED ALL THESE PEOPLE.
IT'S NOT JUST PHYSICIANS, NOT
JUST SCIENTISTS.
ANYBODY WHO HAS WRITTEN OR
OBTAINED AN NIH GRANT REALIZES
YOU NEED ADMINISTRATIVE STAFF
AND BUSINESS PEOPLE TO HELP YOU
THROUGH THE PROCESS.
SO I THINK WE NEED ALL OF THESE
DIFFERENT TYPES OF INDIVIDUALS.
WE NEED TO ATTRACT ALL OF THESE
TYPES OF INDIVIDUALS.
I THINK WE NEED TO ENGAGE ALL OF
THESE TYPES OF INDIVIDUALS, IF
WE'RE GOING TO MAKE MAJOR TOP
TEN CONTRIBUTIONS OVER THE NEXT
40 YEARS.
I'D LIKE TO GIVE YOU -- I'M
GETTING CLOSE TO THE END, I'D
LIKE TO GIVE SOME THOUGHTS ABOUT
COVID AND THE LAST THREE YEARS.
IF YOU'RE NOT SPEAKING, PLEASE
MUTE YOURSELF.
NEXT SLIDE PLEASE.
SO, THERE'S GOOD NEWS.
I THINK REALLY AMAZING NEWS OF
HAVING LIVED THROUGH THE LAST 2
1/2 YEARS.
ONE OF WHICH WAS INCREDIBLE TO
ME HOW EVERYONE, I MEAN EVERYONE
IN SCIENCE AND MEDICINING,
REORIENTED THEIR ATTENTION AND
SKILL SETS FROM WHATEVER THEY
WERE DOING TO FOCUS ON COVID-19.
THAT WAS INCREDIBLE TO ME.
I ALSO THINK THAT THINGS
HAPPENED INCREDIBLY FAST, AND
THERE WAS WONDERFUL SHARING,
COOPERATION, INCREDIBLE
PRODUCTIVITY, THE NUMBERS OF
PAPERS PUBLISHED PER MINUTE WAS
AMAZING.
AND AT LEAST FOR ME THERE WERE
UNIMAGINED ACCOMPLISHMENTS.
I NEVER EXPECTED THAT A VACCINE
WOULD BE AVAILABLE, PROTECTIVE
VACCINE WOULD BE AVAILABLE FOR
COVID WITHIN A YEAR OF THE
IDENTIFICATION OF THE ORGANISM.
IT'S AMAZING TO ME.
THAT WAS GREAT, AND IT'S ONE OF
THE RELATIVELY FEW THINGS THAT
GIVES ME HOPE FOR HUMANITY IN
THESE VERY DIFFICULT AND CHAOTIC
TIMES.
NEXT SLIDE PLEASE.
HOWEVER, I THINK THERE'S SOME
BAD NEWS ALSO, AT LEAST IN MY
OPINION.
I'M GOING TO USE CCP AS MY
EXAMPLE.
I'M ALSO -- I WAS ALSO INVOLVED,
I'M ALSO AT FAULT FOR SOME OF
THIS.
I THINK IF YOU LOOK BACK, IF
WE'RE SELF-CRITICAL, IT WAS A
LACK OF COORDINATION.
EVERYBODY WAS DOING GREAT
THINGS.
EVERYBODY GOT ENGAGED, WAS
INVOLVED.
BUT THERE WAS REALLY A LACK OF
COORDINATION.
I THINK THERE WAS A LOT OF POOR
DECISION MAKING.
AGAIN, ON MY PART, IN ADDITION
TO OTHERS.
I THINK THERE WAS A LOT OF POOR
SCIENCE, MUCH OF WHICH ALSO GOT
PUBLISHED.
NEXT SLIDE PLEASE.
AND SO I WOULD LIKE TO PROPOSE
TO THE NIH, ALTHOUGH IT'S OUT OF
THE SCOPE OF THIS MEETING, ONE
POSSIBLE SOLUTION.
NEXT SLIDE PLEASE.
ONE THING I THINK IS DONE
INCREDIBLY WELL OVER THE LAST
20+ YEARS IS THE NIH-FUNDED REDS
PROGRAM, INCREDIBLY SUCCESSFUL,
I'VE GOTTEN TO KNOW IT MORE UP
CLOSE AND PERSONAL OVER THE LAST
COUPLE YEARS AS NEW YORK CITY
HAS BECOME ONE OF THE HUBS.
NEXT SLIDE PLEASE.
IT'S A HIGHLY PRODUCTIVE
PROGRAM.
I THINK IT WONDERFUL FOSTERS
TRAINING AND COLLABORATION.
THE WHOLE IS GREATER THAN THE
SUM OF THE PARTS AS THE GROUP
WORKS TOGETHER TO TRY TO DO EVEN
BETTER THINGS THAN ANY ONE
PERSON IN THE GROUP COULD THINK
OF ON THEIR OWN.
AND I THINK IT ALSO RAPIDLY CAN
REORIENT ITSELF TO DEAL WITH
IMMINENT THREATS, WHETHER ZIKA
OR EVEN COVID, THE THE GROUP CAN
REORIENTS ITSELF AND APPLY ITS
STRENGTHS AND RESOURCES TO
WHATEVER THE IMMINENT THREAT IS.
HOWEVER, ONE OF THE PROBLEMS IN
MY VIEW, THE WAY IT IS
CONSTITUTED, IT'S LIMITED TO
ONLY OBSERVATIONAL STUDIES
INCLUDING DURING COVID, COULD
ONLY DO OBSERVATIONAL STUDIES.
NEXT SLIDE PLEASE.
I REALLY THINK WHAT WE NEED, WE
HAD SOMETHING LIKE THIS A
NEWBORN OF YEARS, I WAS ONE OF
THE SEVERE CRITICS OF THE
PROGRAM I MUST ADMIT, I THINK WE
NEED ANALOGOUS PROGRAM FOR
PROSPECTIVE STUDIES, SHOULD BE
NIH FUNDED AND GIVEN MY
EXPERIENCE WITH COVID AND THE
WONDERFUL WORK AROUND THE WORLD
AND WONDERFUL COLLABORATION
AROUND THE WORLD, I THINK IT
NEEDS TO BE INTERNATIONAL IN
SCOPE.
I THINK IT NEEDS TO FUND PEOPLE
AROUND THE WORLD.
REDS HAS AN INTERNATIONAL PART
OF ITS PROGRAM NOW TOO.
IT CAN INCLUDE TRAINING IN
RANDOMIZED CONTROLLED TRIALS,
WHICH HAS UNIQUE ISSUES, COULD
HAVE A SINGLE IRB TO FOSTER
RESEARCH AND THINGS LIKE THAT.
NEXT SLIDE PLEASE.
SO FINALLY, IN CONCLUSION, I'D
LIKE TO MAKE ACKNOWLEDGMENTS.
I'VE BEEN ASSOCIATED ONE WAY OR
THE OTHER WITH THE NIH SINCE
1983 WHEN I ARRIVED ON THE
INTRAMURAL BETHESDA CAMPUS TO BE
A MEDICAL STAFF FELLOW IN WHAT
WAS NIADDK, MEANTORY WAS VIC
GINSBERG, NO LONGER WITH US.
I'VE BEEN FORTUNATE MYSELF AND
COLLEAGUES TO BE FUNDED
PRIMARILY BY NHLBI AND CURRENT
PEOPLE WHO I WOULD LIKE TO
THANK, INCREDIBLE, SIMONE AND
TRACI, LISBETH AND SHIMIAN.
GRANT PROPOSALS GET REVIEWED
THROUGH CENTER FOR SCIENTIFIC
REVIEW.
FOR THE FIRST TIME EVER STARTING
A COUPLE YEARS AGO THERE'S
TRANSFUSION IN THE NAME OF A
STUDY SECTION, HTBT STUDY
SECTION, I'M FORTUNATE ENOUGH TO
BE A STANDING MEMBER, AI-PING
AND KATHERINE ARE THE DIRECTORS,
YOU CAN BLAME ME IF YOU DON'T
FEEL YOUR GRANTS WERE REVIEWED
BUT WE DO THE BEST WE CAN AND
PLEASE REMEMBER THIS IS A HUMAN
CONSTRUCT.
NEXT SLIDE PLEASE.
FINALLY, ROZ IS A CONTRIBUTOR TO
THE NEW YORKER, I'VE BEEN
ENJOYING HER CARTOONS MY WHOLE
ADULT LIFE.
THIS JUST RECENTLY CAME OUT.
I THINK IT'S QUITE RELEVANT TO
US, QUITE RELEVANT TO TODAY.
THESE ARE THE FREQUENTLY ASKED
QUESTIONS OF LIFE.
NEXT SLIDE PLEASE.
SO WHEN YOUR NEW RESIDENTS AND
FELLOWS STARTED IN JULY
QUESTIONS THEY WERE, WHAT THE
HELL'S GOING ON?
I DON'T KNOW WHAT I'M DOING?
THEY WOULD ASK WHY ME, AND AS
THEY ARE ATTENDINGS YOU MIGHT
HAVE HAD THESE QUESTIONS ABOUT
THEM, WHICH IS WHERE DID YOU GET
THAT IDEA, WHO DO YOU THINK
YOU'RE KIDDING?
A QUESTION I ASK A LOT.
WHEN YOU GET TO MY AGE, NEXT
SLIDE, ONE OF THE QUESTIONS THAT
WILL INEVITABLY COME UP, IS THIS
ALL THERE IS?
AND I WOULD LIKE TO ANSWER THAT
QUESTION AFFIRMATIVELY, THAT'S
NOT TRUE.
NEXT SLIDE PLEASE.
THAT WE STILL HAVE A LOT OF WORK
TO DO.
IT'S GOING TO REQUIRE ALL OF US
TO PARTICIPATE IN SOME ROLE,
WHETHER THAT'S BY DOING, OR
MENTORING, OR CRITIQUING, OR
EDITING OR WHATEVER, THERE'S
STILL A LOT FOR ALL OF US TO DO,
EVEN SOMEONE CLOSER TO THE END
OF HIS CAREER THAN THE
BEGINNING.
NEXT SLIDE PLEASE.
AND THIS IS JOHN GORMAN, NOW 91
YEARS OLD.
ONE OF THE INVENTORS OF HR
IMMUNE GLOBULIN, I'M HONORED TO
SAY IS A FRIEND, AT 91 MORE
ENERGY, IDEAS, MORE CREATIVITY
THAN ANYONE I KNOW, CERTAINLY
ME.
AND I FEEL EVERY DAY HE'S
LOOKING OVER MY SHOULDER ASKING
ME WHAT I DID TODAY.
SO, MAY HE LOOK OVER YOUR
SHOULDER TOO.
THANK YOU VERY MUCH FOR THIS
OPPORTUNITY.
THANK YOU.
>> THANK YOU SO MUCH, DR.
SPITALNIK, FOR THE OPENING
COMMENTS AND REALLY HELPING US
THINK NOT ONLY ABOUT WHERE WE
ARE BUT WHERE WE'RE GOING AND
HOW WE HAVE TO GET THERE
TOGETHER.
TRULY APPRECIATE THAT OVERVIEW
BECAUSE IT'S A BEAUTIFUL
INTRODUCTION TO NOW REALLY WHAT
ARE THOSE PRIORITIES THAT THE
WORKING GROUPS HAVE DEVELOPED,
AND THAT OPPORTUNITY FOR ALL OF
THE PARTICIPANTS TO JOIN US AND
COMMENT ON THOSE PRIORITIES AND
ALSO FURTHER DEVELOP PRIORITIES.
WE'LL MOVE INTO THE GENERAL
SESSION FOR THAT OVERALL PROGRAM
FOR THE STATE OF THE SCIENCE AND
WE'LL BEGIN WITH DOCTORS BRYANT
AND SAYERS.
AND THEY WILL PRESENT TO US THE
WORKING GROUP PRIORITIES DEFINED
FOR BLOOD DONORS AND THE SUPPLY,
DIVERSIFYING WHILE MAINTAINING
THE DONOR POOL, DONOR SELECTION,
OPTIMIZING BLOOD AVAILABILITY
AND SAFETY.
I WILL HAND IT OVER TO DR.
BRYANT RIGHT NOW.
BEFORE I DO, I WILL JUST SAY
THAT I'M NOT GIVING A DETAILED
INTRODUCTION.
ALL THE BIOS FOR WORKING GROUP
CHAIRS ARE PROVIDED IN A
PAMPHLET LATER SO YOU'LL HAVE
MORE INFORMATION.
I DON'T WANT TO SHORT SHRIFT BUT
LET YOU KNOW DETAILS WILL BE
AVAILABLE FOR REVIEW.
I'LL TURN IT OVER TO DR. BRYANT,
PLEASE.
>> CAN EVERYONE SEE MY SLIDES?
>> WE CAN SEE YOUR SLIDES AND
NOW HEAR YOU.
THANK YOU.
>> EXCELLENT.
THANK YOU.
THANK YOU FOR THE INTRODUCTION,
BRIAN.
I'D LIKE TO THANK THE NHLBI,
OASH, AND THE CHAIRS FOR THEIR
HARD WORK AND DEDICATION
ORGANIZING THIS SYMPOSIUM.
I'M BARBARA BRYANT, WITH MERLYN
SAYERS WE'RE THE CO-CHAIRS OF
WORKING GROUP NUMBER 1.
WORKING GROUP NUMBER 1, FOCUSED
ON IMPORTANT TOPIC, BLOOD DONORS
AND THE BLOOD SUPPLY,
DIVERSIFYING WHILE MAINTAINING
THE DONOR POOL, DONOR SELECTION,
OPTIMIZING BLOOD AVAILABILITY
AND SAFETY.
SO AS WE HEARD THIS MORNING,
FROM ADMIRAL LEVINE, IN THE U.S.
ABOUT 62% OF THE POPULATION IS
ELIGIBLE TO DONATE BLOOD.
THAT'S ABOUT 205 MILLION
INDIVIDUALS.
BUT ONLY 3% OF THE U.S.
POPULATION DONATES BLOOD EACH
YEAR.
SO, OF ALL THE WHOLE BLOOD AND
APHERESIS RED CELL DONATIONS,
LESS THAN 20% COME FROM RACIAL
OR ETHNIC MINORITY DONORS.
AND FROM 2017 TO 2019 THERE WAS
A 15% DECREASE IN DONATION FROM
INDIVIDUALS IN THE 19 TO 24 YEAR
AGE RANGE.
WE KNOW WE NEED MORE
PARTICIPATION FROM DIVERSE AND
YOUNGER DONORS TO SUPPORT THE
NATION'S BLOOD TRANSFUSION NEEDS
TODAY AND ESPECIALLY IN THE
FUTURE.
AND PAST AND CURRENT INITIATIVES
TO ADDRESS THESE ISSUES HAVE NOT
RESULTED IN DEPENDABLE SOLUTIONS
THAT WILL ENSURE ADEQUACY,
SUSTAINABILITY, AND DIVERSITY OF
THE BLOOD SUPPLY.
IN THE PAST YEAR WE'VE ALL DEALT
WITH TREMENDOUS CHALLENGES
FACING THE BLOOD SUPPLY.
MANY TIMES BLOOD INVENTORIES
DROP TO LESS THAN 24-HOUR SUPPLY
LEVEL FORCING MANY HOSPITALS TO
TRIAGE BLOOD PRODUCTS, LOWER
THRESHOLD FOR TRANSFUSION, IN
SOME CASES SURGERIES WERE
CANCELED, POSTPONED, THERE WERE
REPORTS OF NOT ENOUGH BLOOD FOR
PATIENTS.
MANY SUGGESTED IT'S TIME TO STEP
OUTSIDE AND DEVELOP INNOVATIVE
APPROACHES FOR DIVERSIFYING AND
SUSTAINING THE BLOOD SUPPLY.
IF WE DO WHAT WE'VE BEEN DOING
WE'LL MOST LIKELY GET THE SAME
RESULT.
SO, AFTER REVIEWING THE
LITERATURE AND RECENT AND PAST
LITERATURE, SPEAKING TO THOUGHT
LEADERS AND CHANGE LEADERS
ACROSS THE UNITED STATES AND
GLOBALLY, MERLYN AND I PUT
TOGETHER A DYNAMIC GROUP OF
INDIVIDUALS FOR WORKING GROUP
NUMBER 1.
THE MEMBERS INCLUDE MEDICAL
DIRECTORS, NURSES, EDUCATORS,
MARKETING AND COMMUNICATION
SPECIALISTS, BIOMEDICAL
PARTNERSHIP MANAGERS, PSYCHOLOGY
PROFESSOR ALREADY WELL KNOWN IN
THE FIELD, APPLIED MEDICAL
ANTHROPOLOGIST, APPLIED
MATHEMATICIAN WHO SPECIALIZES IN
ALGORITHMS AND A.I. FOR
DETERMINING BEHAVIORS AND
DECISION MAKING, TRANSFUSION
MEDICINE FELLOW, AND A COMMUNITY
REPRESENTATIVE OR STAKEHOLDER
WHO IS A STRONG ADVOCATE FOR
SUPPORTING BLOOD DONATION FROM
UNDERREPRESENTED COMMUNITIES.
THE SLIDES FOR THIS PRESENTATION
WERE PREPARED BY EVERYONE IN
THIS WORKING GROUP.
SO, THESE ARE THE FIVE DRAFTS
RESEARCH PRIORITIES WE
IDENTIFIED.
NUMBER 1, MOTIVATORS AND
BARRIERS TO BLOOD DONATION.
NUMBER 2, DONOR EXPERIENCE AND
SUBSEQUENT DONOR BEHAVIOR.
NUMBER 3, INCENTIVES, DONOR
APPRECIATION AND COMPENSATION.
NUMBER 4, OPTIMIZING
COMMUNICATIONS WITH DONORS AND
POTENTIAL DONORS.
NUMBER 5, INNOVATIVE AND
INCLUSIVE USES OF INFORMATION
AND COMMUNICATION TECHNOLOGY.
SO FOR THE FIRST DRAFT PRIORITY,
MOTIVATORS AND BARRIERS, WHAT
ARE THE MOTIVATORS AND BARRIERS
TO INITIAL AND REPEAT BLOOD
DONATION, PARTICULARLY AMONG
YOUNGER INDIVIDUALS AND PEOPLE
OF DIVERSE BACKGROUNDS WHO ARE
CURRENTLY UNDERREPRESENTED IN
THE DONOR POOL?
THE PROBLEM IS IN THE U.S. WE'RE
FACED WITH ONGOING CHALLENGES
RELATED TO RECRUITMENT AND
RETENTION OF A NEW GENERATION OF
DONORS.
AND PARTICULARLY NOTEWORTHY
UNDERREPRESENTATION.
WHY IS THIS AN ISSUE?
THERE IS A SIZEABLE LITERATURE
ON BLOOD DONOR MOTIVATION, MAJOR
DEMOGRAPHIC, TECHNOLOGICAL AND
SOCIETAL CHANGES HAVE TAKEN
PLACE SINCE THE WORK WAS
PUBLISHED AND POTENTIAL IMPACT
OF CHANCE ON DONOR RECRUITMENT
AND RETENTION ARE NOT WELL
UNDERSTOOD.
DO BARRIERS REMAIN RELEVANT?
DO THEY HAVE THE SAME MEANING
TODAY AS IN THE PAST?
IN THE PAST IT SEEMED THE
MOTIVATORS WERE ALTRUISM, SAVE A
LIFE, NOW WE'RE FINDING MORE
THAT IT'S BENEVOLENCE AND THE
MESSAGE OF SAVE A LIFE IS A
TURNOFF TO A LOT OF DONORS.
ALSO WHAT ROLE DOES SOCIALIST
THEME PLAY IN THE MOTIVATION?
AS FAR AS BARRIERS, DID WE GET
TOLD IT'S CONVENIENT, THE TIME,
I HAVE ADMIT AT NIH OUR DONORS
HAVE TO GET THROUGH THE
PERIMETER, GO THROUGH HAVING THE
CAR SCREENED AND PARK, WAIT IN
LINE TO GET IN THE BUILDING
BEFORE THEY CAN GET SCREENED
AGAIN TO GET TO THE DONOR ROOM.
SO HOW DO THESE BARRIERS,
CONVENIENCE, FEAR, NEGATIVE
EXPERIENCES, REALLY IMPACT OUR
DONORS?
AND WHAT ARE THESE MOTIVATIONS
AND BARRIERS ACROSS SEX AND
GENDER, GENERATIONS, RACE,
ETHNICITY, AND GEOGRAPHY?
AS THE U.S. BECOMES MORE
DIVERSE, BLOOD DONOR MOTIVATION
MUST BE PURSUED IN A RANGE OF
COMMUNITIES.
PEOPLE OF COLOR, RELIGIOUS
MINORITIES, RECENT IMMIGRANT
GROUPS, ANDS HOW CAN WE
ENCOURAGE AND SUSTAIN DONORS AND
ENGAGE THOSE WHO NEVER
DONATEDs FROM DIFFERENT
COMMUNITIES?
SO, WHAT IS THE PROPOSED
APPROACH TO THIS RESEARCH?
NEEDED STUDIES WILL RANGE FROM
OBSERVATIONAL, QUALITATIVE,
MIX-METHOD DESIGNS, RANDOM
CLINICAL TRIALS INTENDED TO
EVALUATE NEW APPROACHES TO
RECRUITMENT AND RETENTION.
HOW FEASIBLE ARE THESE?
WHAT ARE THE BARRIERS?
METHODOLOGICAL APPROACHES
REQUIRED TO PRODUCE THIS
EVIDENCE DO NOT PRESENT UNDUE
CHALLENGE, WITH MANY EXISTING
EXAMPLES OF OBSERVATIONAL,
SURVEY, AND RANDOMIZED TRIALS
WITH BLOOD DONORS.
SO HOWEVER THESE STUDIES MUST BE
CONSIDERED NESTED, INTERACTING
INFLUENCES ON DONATION AND
BEHAVIOR OVER TIME INCLUDING
INDIVIDUAL RELATIONSHIP
ORGANIZATIONAL AND SOCIETAL
FACTORS.
SO, IN THIS DIAGRAM YOU SEE THE
INDIVIDUAL INFLUENCES SUCH AS
ALTRUISM, BENEVOLENCE,
VASOVAGAL, FAMILY, PEER, ONLINE
SOCIAL NETWORKS WHICH, AGAIN, IS
NESTED WITHIN ORGANIZATIONAL
INFLUENCES, ACCESS TO DONATION,
OPPORTUNITIES, CULTURALLY
TAILORED COMMUNICATION, AND
INCENTIVES, AND THEN SOCIETY'S
INFLUENCE, TRUST, ACCESS,
TREATMENT BASED ON RACE,
ETHNICITY, SEXUAL ORIENTATION.
COMMUNITY-BASED PARTICIPATORY
RESEARCH WILL BE PARTICULARLY
VALUABLE IN ASSURING ACCURATE
CONSIDERATION OF ALL THESE
FACTORS AND NESTED INFLUENCES ON
DONATION BEHAVIOR.
DRAFT PRIORITY NUMBER 2, DONOR
EXPERIENCE.
THE QUESTION IS WHAT IS THE
DONOR'S EXPERIENCE FROM THE
DONOR PERSPECTIVE?
HOW DOES IT VARY AND HOW DOES IT
RELATE TO SUBSEQUENT DONOR
BEHAVIOR?
THE PROBLEM IS, BLOOD DONATION
EXPERIENCES APPEAR TO INFLUENCE
SUBSEQUENT DONATION PRACTICES.
BUT MOST ASPECTS OF THIS
EXPERIENCE OUTSIDE OF TH ADVERSE
REACTIONS RECEIVED LITTLE
ATTENTION.
IT IS OPERATIONALIZED BY
RESEARCHERS RATHER THAN DEFINED
OR EXPLORED WITH THE RESEARCH
PARTICIPANTS.
THE IMPACT OF DONOR DIVERSITY IS
RARELY ADDRESSED IN THESE
STUDIES AS WELL.
SO WHY IS THIS AN ISSUE?
DONOR RECRUITMENT AND RETENTION
EFFORTS COULD BE CUSTOMIZED TO
BE MORE EFFECTIVE WITH IN DEPTH
AND AWARE UNDERSTANDING OF DONOR
EXPERIENCE.
FOR INSTANCE, WHAT ARE THE
DONOR'S PERCEPTIONS, WHAT DO
THEY UNDERSTAND ABOUT
ELIGIBILITY CRITERIA AND
DEFERRAL AND RECENT CHANGES TO
SOME CRITERIA.
DO THEY UNDERSTAND THE SCREENING
QUESTIONS AND WHY THEY ANSWER
THE WAY THEY DO?
HOW DOES THIS PERCEPTION
MOTIVATE OR DETER DONATION
BEHAVIOR?
AND WE MEAN THAT OUR
UNDERSTANDING OF THE DONOR
EXPERIENCE NEEDS TO INCORPORATE
ELEMENTS LIKE DEMOGRAPHIC
DIVERSITY, TYPE OF DONATION THEY
ARE ABOUT TO MAKE, DONOR CAREER
STAGE AND FREQUENCY, GEOGRAPHY,
DONATION LOCATION, AND OTHER
INTERACTING FACTORS.
INDIVIDUAL PERCEPTIONS
OBJECTIVELY SIMILAR EXPERIENCES
OFTEN VARY, AND BLOOD DONATION
IS LIKELY NO EXCEPTION.
WE NEED TO SAMPLE DIVERSE
DONORS, RACE AND ETHNICITY,
GENDER, AGE, NOVICE EXPERIENCE
AND THAT WILL HELP ENABLE US TO
EXAMINE THIS VARIATION, FROM THE
DONOR PERSPECTIVE DO THEY FEEL
WELCOME OR VALUED WHEN THEY COME
TO THE CENTER WHEN DEALING WITH
THE FRONT LINE STAFF?
ARE TIME COMMITMENTS BEING
UPHELD?
AND FOR THE FRONT LINE STAFF
THAT DEALS WITH THESE DONORS DAY
IN AND DAY OUT ARE THERE FACTORS
AND INFLUENCES THAT LEAVE THEY
WILL WELL OR ILL EQUIPPED TO
PROVIDE THE EXPERIENCE THE DONOR
WANTS AND EXPECTS? GIVEN THE
COALS OF BOLSTERING
SUSTAINABILITY OF THE BLOOD
SUPPLY AND ADVANCING HEALTH
EQUITY, RESEARCH MUST INCLUDE
PER SPECK PERSPECTIVES AND
PEOPLE OF COLOR.
MORE MAXIMUM IMPACT RESEARCH
SHOULD EXAMINE RELATIONSHIP
BETWEEN DONOR EXPERIENCE,
REPORTED BEHAVIOR.
PROPOSED RESEARCH APPROACH IS
LIKE A RESEARCH TRAJECTORY THAT
STARTS WITH RESEARCH AND MOVES
TO MIXED METHOD AND HYPOTHESIS
TESTING, THEN INTO
EVIDENCE-BASED INTERVENTIONS,
AND TESTING WITH EVENTUALLY
GETTING TO TRANSLATIONAL
RESEARCH PUTTING THESE EFFECTIVE
INTERVENTIONS INTO PLACE.
IT'S IMPORTANT TO ENGAGE WITH
UNDEREXPLORED POTENTIAL
INFLUENCES ON THE DONOR
EXPERIENCE.
EMOTIONS, SOCIAL FACTORS,
EVERYDAY LIFE EXPERIENCE OUTSIDE
OF DONATIONS.
CULTURAL DYNAMICS, INEQUALITY,
DONOR CENTER ENVIRONMENT.
APPROPRIATE STUDY DESIGNS WILL
VARY DEPENDING WHAT STAGE OF THE
RESEARCH TRAJECTORY THAT YOU'RE
IN.
WHAT IS FEASIBILITY AND
BARRIERS?
WELL, RESEARCH METHODS AND TOOLS
ESSENTIAL TO ADDRESS QUESTIONS
ARE WIDELY ACCESSIBLE,
MULTI-METHOD, THEORY-INFORMED
LONGITUDINAL APPROACHES.
THERE ARE CHALLENGES, POTENTIAL
LOW LOGISTIC PARTNERING WITH
BLOOD ORGANIZATIONS, ALSO
ANALYTICAL CHALLENGE, COMPLEXITY
OF HUMAN EXPERIENCE, IDENTIFYING
MULTIPLE INFLUENCES AND
UNDERSTANDING INTERACTION WHICH
MAY DIFFER ACROSS PARTICIPANTS
AND DONORS.
EVENTUALLY, MULTI-SITE TRIALS OF
POSSIBLE INTERVENTIONS WILL BE
NEEDED AS GEOGRAPHY, REGION IN
THE UNITED STATES MAY INFLUENCE
DONOR'S PERSPECTIVE AND THEIR
BEHAVIOR.
TRANSLATING EFFECTIVE
INTERVENTIONS INTO PRACTICE MAY
ALSO PROVE CHALLENGING AS BLOOD
COLLECTION ORGANIZATIONS FACE
MANY CONSTRAINTS.
DRAFT PRIORITY NUMBER 3,
INCENTIVES AND COMPENSATION.
SO WHAT INCENTIVE STRATEGIES
MOST EFFECTIVELY DRIVE BLOOD
DONATION?
FOR VARIOUS TYPES OF DONORS, HOW
WOULD OFFERING COMPENSATION FOR
BLOOD IMPACT DONOR BEHAVIOR IN
THE BLOOD SUPPLY?
THE PROBLEM IN THE UNITED STATES
THE BLOOD SYSTEM IS BASED ON
VOLUNTARY DONORS, OFFERING
INCENTIVES HAVE NOT STABILIZED
INVENTORIES UP TO NOW.
WHY IS THIS AN ISSUE?
THERE'S A NEED TO UNDERSTAND
CURRENT IMPLEMENTATION AND
IMPACT OF INCENTIVIZATION,
RESEARCH MAY IMPROVE THE
STABILITY AND EFFICIENCY OF THE
BLOOD SYSTEM.
WHAT IS THE PROPOSED RESEARCH?
RESEARCH ON INCENTIVE STRATEGIES
AND THEIR IMPACT WILL REQUIRE
MULTI-PHASED TRAJECTORY WITH
FORMATIVE RESEARCH,
HYPOTHESIS-TESTING AND STUDIES.
QUESTIONS ARE TO FIND OUT WHAT
DO DONORS UNDERSTAND AS
INCENTIVES AND WHAT ARE
PREFERENCES?
WHEN WE THINK OF INCENTIVE IT
COULD BE T-SHIRTS, MUST BE,
SWEATSHIRTS, OR TIME OFF,
RAFFLES, POSSIBLY AND INCLUDING
MONEY.
WE NEED TO EXAMINE ROLE OF
INCENTIVES ACCOUNTING FOR
PRESENTING BARRIERS.
AS FAR AS MOTIVATORS GO, DO
INCENTIVES DRIVE BEHAVIOR?
THERE ARE MANY COUNTRIES THAT DO
NOT GIVE INCENTIVES AND DON'T
HAVE TROUBLE RECRUITING DONORS
BUT IN THE UNITED STATES DOES IT
DRIVE BEHAVIOR?
WILL IT HELP WITH GOAL OF
RECRUITING THE YOUNGER AND MORE
DIVERSE DONOR?
AND THE BARRIERS ARE, WELL,
WOULD OTHERS NOT WANT
COMPENSATION, WOULD IT BE A
BUSINESS TRANSACTION?
SO WE NEED TO HAVE ANALYSIS DONE
ON THE IMPACT AND MULTIPLE
FACTORS SUCH AS RACE, ETHNICITY,
GENDER, AGE, GEOGRAPHY, DONATION
FREQUENCY AND HOW THAT PLAYS
INTO INCENTIVE STRATEGIES.
AND STUDIES MUST BE LONGITUDINAL
TO DOCUMENT CHANGES IN DONOR
ATTITUDE, BEHAVIOR AND
EXPECTATION OVER TIME, AS WELL
AS IMPACT OF THESE STRATEGIES ON
BLOOD CENTERS AND SUPPLY.
IN CONTINUING WITH PROPOSED
APPROACHES WE NEED TO EVALUATE
IMPACT OF INTRODUCING A
COMPENSATED BLOOD COLLECTION IN
TERMS OF BLOOD SAFETY,
AVAILABILITY, MOTIVATION TO GIVE
OR CONTRIBUTE AND COST
STRUCTURE.
I HAVE TO SAY WORKING GROUP 1
SPENT CONSIDERABLE AMOUNT OF
TIME TO DETERMINE WORDING.
MAYBE IT SHOULD BE VENDOR,
BECAUSE THEY ARE NOT A DONOR
BECAUSE THEY ARE GETTING PAID,
OR JUST CONTRIBUTOR?
AND ALSO FROM THE BLOOD CENTER
STANDPOINT, INDUSTRY STANDPOINT,
IF WE ARE GOING TO PAY DONORS TO
DONATE BLOOD WILL THE COST OF A
PAID DONOR MODEL BE PASSED TO
THE HOSPITALS?
WILL THIS SET UP A COST WAR
BETWEEN BLOOD CENTERS WHERE YOU
CAN GET PAID A CERTAIN AMOUNT AT
ONE BLOOD CENTER, DOWN THE
STREET FURTHER THEY WILL PAY YOU
A LITTLE BIT MORE FOR THE SAME
PRODUCT THAT YOU'RE DONATING.
AGAIN, WE NEED TO INVESTIGATE
HOW THIS IMPACT MIGHT DEPEND ON
WHAT PRODUCTS, WHAT COULD BE
INCLUDED FOR COMPENSATION, HOW
MUCH AND WHAT TYPE OF
COMPENSATION IS OFFERED.
SO ARE WE GOING TO COMPENSATE
FOR PLATELETS OR PLASMA OR RED
CELLS?
AND WILL OUR DONORS UNDERSTAND
WHY SOME GET PAID MONEY, SOME
DON'T?
DOES IT CHANGE DONATION
PRACTICES?
WILL EVERYBODY SWITCH TO
WHATEVER PRODUCT, WHERE THEY GET
PAID?
HOW MUCH MONEY IS ENOUGH TO
AGAIN COMPENSATE?
ARE YOU COMPENSATING FOR TIME?
IS IT THE MINIMUM WAGE, WHAT ARE
WE LOOKING AT HERE?
ALSO HOW DONOR IDENTITY MIGHT
EVOLVE.
THE IMPACT OF BECOMING A PAID
DONOR MAY CHANGE THAT.
DOES IT HAVE A POSITIVE OR
NEGATIVE SPIN?
IT'S POSSIBLE THAT WE MAY OFFEND
OR POSSIBLY LOSE LOYAL BLOOD
DONORS WHO WERE NEVER PAID IN
THE PAST, NOW INSULTED THAT THEY
COULD HAVE BEEN DOING IT FOR
MONEY AND DON'T UNDERSTAND THE
TRANSITION TO A COMPENSATED
MODEL.
BECAUSE COMPENSATED COLLECTION
OF CERTAIN COMPONENTS OCCURS IN
THE U.S., RESEARCH THAT EXPLORES
NON-REMUNERATED, OVERALL
COMPARISONS WITH PLASMA INDUSTRY
MAY BE INSTRUCTIVE.
WHAT ARE THE FEASIBILITY AND
BARRIERS?
AS LONG AS THE REPORTED
PREFERENCE CAN CAN BE LINKED TO
BEHAVIOR IT CAN BE PERFORM WITH
SURVEYS, INTERVIEWS, FOCUS
GROUPS, EXPERIMENTAL DESIGNS.
EFFECTS OF OFFERING FINANCIAL
COMPENSATION FOR BLOOD ARE
UNKNOWN.
AND ANY EVENTUAL INTERVENTION
STUDY SHOULD BE CONDUCTED IN
MULTIPLE LOCATIONS, TO PROVIDE
CONTEXT TO THE IMPACT.
FURTHER, THIS RESEARCH WILL NEED
TO BE LONGITUDINAL TO DOCUMENT
DISRUPTION OF THE CURRENT
UNREMUNERATED MODEL AND
CONSEQUENCES DRIVEN BY
ADJUSTMENTS TO IT.
NOW, DRAFT PRIORITY NUMBER 4,
MESSAGING AND CHANNELED, THE
QUESTION IS, IN TERMS OF
COMMUNICATING WITH DIVERSE BLOOD
DONORS AND POTENTIAL DONORS,
WHAT ARE THE CHARACTERISTICS TO
WHICH MESSAGES SHOULD BE
TAILORED, WHAT CONTENT IS MOST
RESONANT, WHICH CHANNELS AND
MODALITIES ARE MOST EFFECTIVE
AND HOW CAN EFFECTIVENESS BE
MARRIED?
THE PROBLEM IS IN AN AGE OF
EXTENSIVE DATA INFORMED TARGET
MARKETING, THE PRESUMPTION IS
THAT RELEVANCE AND
PERSUASIVENESS CAN BE ENCHANCED
THROUGH TAILORING YET THERE'S
LITTLE RESEARCH ON SUCH EFFORTS
FOR BLOOD DONATION IN THE U.S.
ENVIRONMENT.
SO WHY IS THIS AN ISSUE?
COMMUNICATION CHANNELS,
EFFECTIVE MESSAGING, TECHNOLOGY
CHANGES OCCUR SO RAPIDLY,
CENTERS MAY NOT MAXIMIZE USE OF
DOLLARS AND OPPORTUNITIES,
IMPACTING THEIR ABILITY TO REACH
NEW AND EXISTING BLOOD DONORS TO
ENSURE ADEQUATE BLOOD SUPPLY FOR
ALL.
STUDIES ARE NEEDED TO ASCERTAIN
HOW TO TAILOR AND DELIVER THIS
COMMUNICATION ACROSS DIVERSE
SUBPOPULATIONS OF PATIENTS, I'M
SORRY, DONORS, HARNESSING POWER
TO DRIVE BLOOD DONATION MAY HELP
ENSURE SUFFICIENCY OF BLOOD
SUPPLY.
WHAT WOULD BE THE PROPOSED
APPROACH?
BASIC RESEARCH IS NECESSARY TO
DETERMINE APPROPRIATE
SEGMENTATION PRACTICES FOR
POTENTIAL DONORS.
SO EVIDENCE SUGGESTS THAT
RACIAL, ETHNIC, GEOGRAPHIC AND
DONATION PRODUCT BASED GROUPS
MIGHT BE RELEVANT BUT TARGETING
MIGHT BE EQUALLY OR MORE
EFFECTIVE.
NEED TO DETERMINE WHAT CONTENT
RESONATES FOR EACH GROUP.
IN OTHER WORDS, IS IT A POSITIVE
MESSAGE THAT WE'VE USED LIKE
SAVE A LIFE OR IS IT A REALISTIC
MESSAGE, WE HAVE HORRIBLE BLOOD
SHORTAGE, NOT ENOUGH BLOOD TO
TAKE CARE OF PATIENTS, SURGERIES
CANCELED, WHICH CONTENT
RESONATES FOR EACH GROUP?
EFFECTIVENESS IS LINKED TO DONOR
MOTIVATION, THIS TYPE OF
RESEARCH SHOULD SEEK TO EXPLAIN
NOT ONLY WHAT WORKS BUT WHY IT
WORKS.
AND EVALUATE THE IMPACT OF
DIFFERENT DELIVERY CHANNELS FOR
THESE MESSAGES.
THE INTENT IS YOU WANT TO MAKE
SURE THE MESSAGING INCREASES
VISIBILITY, RELATABILITY,
COMPREHENSION AROUND THE NEED
FOR DONATION AND WILL MOVE
DONORS TOWARD WILLINGNESS TO
DONATE.
YOU HAVE TO WATCH POSITIVE
VERSUS OVERDOING IT.
I LIKE IT THE STORY ABOUT HARVEY
ALTER.
WE GET CALLS ABOUT OUR CAR
WARRANTY ON OUR NIH PHONES.
WHEN HE GOT HIS PHONE CALL ABOUT
WINNING THE NOBEL PRIZE HE
DIDN'T ANSWER UNTIL THE THIRD
CALL BECAUSE HE KNEW IT WAS
SOMETHING ABOUT A CAR WARRANTY.
IT WAS 4:00 IN THE MORNING BUT
HE DID NOT ANSWER UNTIL THE
THIRD PHONE CALL.
YOU DON'T WANT WITH THESE
IMPACTED DELIVERY CHANNELS TO
ENDS UP WITH NUMBNESS.
YOU WANT TO MOVE DONORS TOWARD
DONATION.
TRADITIONAL AND DIGITAL
CHANNELINGS ARE USED.
CHANNELS ARE POSSIBLE, WE HAVE
TO UNDERSTAND THE BEST MARKETING
CHANNELS FOR EACH GENERATION,
ETHNICITY, GENDER, AND TAKE INTO
ACCOUNT DIGITAL, THOSE WHO
ALWAYS HAD TECHNOLOGY, THOSE
THAT ARE IMMIGRANTS, NOT SO MUCH
UP ON THE TECHNOLOGY BUT WE'RE
TRYING REAL HARD.
SO THE USE OF NEW COMMUNICATION
TECHNOLOGY SHOULD ALSO BE
INVESTIGATED.
AND MEASURING EFFECTIVENESS OF
MARKETING CAN BE A CHALLENGE.
THEREFORE STUDIES NEED TO BE
CAREFULLY DESIGNED SO YOU'RE
ABLE TO PARSE OUT IMPACT
CONTENT, MODE, AND STRATEGIES.
IDEALLY ASSESSMENT WILL LINK
OUTREACH TO DONATION, AS WELL AS
CAPTURING THE MEANINGFUL EFFECTS
OF THOSE ATTEMPTS THAT FALL
SHORT OF DONATION.
WHAT IS THE FEASIBILITY AND
BARRIERS?
TESTING MESSAGES AND CHANNELS IN
CONTROLLED/LAB ENVIRONMENTS IS
FEASIBLE.
HOWEVER, WHEN YOU START LOOKING
AT REAL WORLD STUDIES YOU MAY
ENCOUNTER TWO MAIN CHALLENGES
DUE TO EXTERNAL FACTORS THAT MAY
THREATEN VALIDITY OF THE
RESEARCH FINDINGS.
FIRST OFF, CHANGES IN
ENVIRONMENT DURING THE STUDY, IN
OTHER WORDS UPDATES TO
ALGORITHMS, CHANGES IN SOCIAL
MEDIA PLATFORMS, SHIFTING LAWS
AND PRIVACY POLICIES.
OR PARTICIPANTS MAY OPT TO
DONATE BLOOD DRIVEN BY
INFLUENCES OUTSIDE OF THE STUDY.
A NATIONAL PLEA FOR BLOOD, IN
OTHER WORDS.
THE FEASIBILITY OF THE RESEARCH
MAY BE IMPACTED BY CURRENTLY
LIMITED TECHNOLOGICAL
CAPABILITIES OF MANY U.S. BLOOD
CENTERS.
MANY BLOOD CENTERS LACK
AUTOMATED ABILITY TO CONNECT
SPECIFIC COMMUNICATIONS,
STRATEGIES TO DONATIONS DUE TO
LACK OF SYSTEM INTEGRATION.
IN OTHER WORDS, MARKETING
DEPLOYMENT PLATFORMS.
OR NATURE OF SOCIAL MEDIA, MOST
PEOPLE USE HANDLES, THERE HAS TO
BE A WAY TO PULL HANDLES IN
BECAUSE IT MAY NOT BE A LEGAL
NAME.
CENTERS MAY STRUGGLE TO MEASURE
EFFECTIVENESS, TECHNOLOGY AND
EXPERTISE MAY EXIST EXTERNALLY.
NOW DRAFT PRIORITY NUMBER 5,
INFORMATION/COMMUNICATION
TECHNOLOGY.
THE QUESTION IS, WHAT ROLE DO
INFORMATION AND COMMUNICATION
TECHNOLOGIESES, KNOWN AS ICTs,
PLAY IN RAISING AWARENESS ABOUT
BLOOD DONATION AND RECRUITMENT
AND RETENTION OF BLOOD DONORS?
HOW CAN BLOOD COLLECTION
ORGANIZATIONS USE ICTs AND
INNOVATIVE AND INCLUSIVE WAYS?
THE PROBLEM IS MODERN ICTs
PRESENT MANY OPPORTUNITIES FOR
BLOOD DONATION ORGANIZATIONS TO
IMPROVE ENGAGEMENT WITH DONORS
AND POTENTIAL DONORS BUT OFTEN
ICTs ARE UNDERUTILIZED, NOT
WELL LEVERAGED.
WHY IS THIS AN ISSUE?
ICTs ARE EVERYWHERE AWAY.
MOST OF US CARRY OUR MOBILE
PHONE OR PHONES, WEARABLES,
REALTIME GEO LOCATION.
AUTOMATION, ARTIFICIAL
INTELLIGENCE, MACHINE LEARNING.
AUTOMATION HAS BEEN CREDITED
WITH ON ONE HAND MINIMIZING
HUMAN INTERACTION WHICH SOME
DONORS CAN ENJOY BUT CAN RAISE
INTERACTION THROUGH PERSONAL
CONNECTIONS ON SOCIAL MEDIA.
SO, THERE ARE MANY OPPORTUNITIES
FOR BLOOD COLLECTION
ORGANIZATIONS.
ICTs CAN BE USED FOR DONOR
ENGAGEMENT AND RECRUITMENT,
COORDINATION AND EDUCATION.
EDUCATION FOR NEW DONORS CAN
ADDRESS FEAR, KNOWLEDGE, ACCESS,
ANY OTHER INFORMATION THEY MAY
NEED.
EDUCATION FOR SEASONED DONORS
COULD ADDRESS CONVENIENCE,
PROMOTION OF DONOR IDENTITY AND
CONNECTION WITH OTHER DONORS.
ICTs COULD BE USED FOR
ESPECIALLY SMALLER DONOR CENTERS
THAT DON'T HAVE A DEDICATED
MARKETING AND RECRUITMENT TEAM,
COULD AID WITH THIS INFORMATION.
AND ICTs COULD ESTABLISH THE
BEST PRACTICES FOR STAFFING
DONOR CENTERS.
ALSO OPPORTUNITY TO ASSESS DIE
VEERS -- DIVERSE DONORS.
WHAT IS THE PROPOSED APPROACH?
WHAT ROLES DO ICTs PLAY IN
DONOR RECRUITMENT AND
COORDINATION?
HOW DO DONORS USE ICTS, WHEN
DOES THE CLIP EQUAL A DONATION?
HOW DO BLOOD DONOR COLLECTION
ORGANIZATIONS USE ICTs AND USE
THEM BETTER?
AND DO ICTs FACILITATE
DONATION OR CREATE BARRIERS TO
DONATION?
AND THESE BARRIERS WOULD BE DUE
TO DISPARITIES IN ACCESS, USE OF
ICTs.
THIS TYPE OF RESEARCH WOULD NEED
TO BE CONDUCTED IN DIVERSE
COMMUNITIES, PEOPLE OF COLOR,
YOUNGER AND OLDER DONORS,
NON-ENGLISH SPEAKERS, PEOPLE
LIVING WITH DISABILITIES WHICH
IS ONE GROUP THAT HAS NOT BEEN
INVESTIGATED.
ALSO, TO DEVELOP INNOVATIVE USE
FOR ICTs FOR RECRUITMENT AND
COORDINATION, THIS WOULD BE
GREAT TO LEVERAGE GROUP
COLLECTIVE CONSCIOUSNESS, SUCH
AS TWITTER AND ECHO CHAMBERS,
AND ALSO ROLE OF INFLUENCERS,
NETWORK, CONNECTION TO PEOPLE
MORE INFLUENTIAL THAN
INDIVIDUALS THEMSELVES MAY PLAY
A ROLE IN ICTs.
ALSO METHODS FROM OTHER FIELDS
WILL BE VERY USEFUL AND HELPFUL
AS WE START PROPOSING RESEARCH
IN OUR FIELD.
WHAT ARE THE FEASIBILITY AND
BARRIERS?
SO, THE METHODS FOR STUDYING
ICTs HAVE BEEN DEVELOPED OVER
MANY DECADES, SOCIOLOGY,
PSYCHOLOGY, ANTHROPOLOGY,
MARKETING, MEDIA STUDIES,
HUMAN-COMPUTER INTERACTION.
MODERN ICTs RAISE NOVEL RISK.
YOU HAVE ISSUE OF DONOR PRIVACY,
NEW ICTs GATHER FAR MORE
PERSONAL DATA THAN EARLIER
ICTs.
THE DATA CREATES A GREAT
OPPORTUNITY TO DEVELOP NEW DONOR
ENGAGEMENT STRATEGIES BUT ALSO
POSES RISK TO THE DONOR FOR
PRIVACY AN TRUST.
AND HOW WILL DONORS FEEL ABOUT
SURVEILLANCE?
THE POSITIVE AND NEGATIVES.
WE'VE ALL FELT THIS.
AMAZON, FACEBOOK, EVERY TIME I
LOG ON IT KNOWS WHAT IT IS I
NEED TO ORDER BEFORE I EVEN
THOUGHT OF IT.
AND ALSO ICTs RUN ON
ALGORITHMS.
THERE ARE BUILT-IN BIASES.
MAYBE NEWER ONES WILL HAVE THOSE
ELIMINATED BUT WE HAVE TO TAKE
THIS INTO ACCOUNT AND THERE'S A
NEED TO TRY TO REMOVE THESE
BIASES TO BEST SERVE THE DONORS.
AND THEN FINALLY HERE ABILITY TO
DISPEL DISINFORMATION BUT THERE
IS A POTENTIAL TO SPREAD
MISINFORMATION WITH ICTs, SO
THOSE ARE SOME OF THE CONCERNS
AND RISKS.
IN SUMMARY, DRAFT RESEARCH
PRIORITIES FOR WORKING GROUP 1
ARE MOTIVATORS AND BARRIERS,
DONOR EXPERIENCE, INCENTIVES AND
DOANORY APPRECIATION AND
COMPENSATION FOR BLOOD DONORS,
OPTIMIZING COMMUNICATION WITH
DONORS AND POTENTIAL DONORS,
INNOVATIVE AND INCLUSIVE USE OF
INFORMATION AND COMMUNICATION
TECHNOLOGY.
SO I'D LIKE TO THANK YOU FOR
YOUR ATTENTION.
WE LOOK FORWARD TO INPUT AND
SUGGESTIONS AS WE DISCUSS THESE
DRAFT RESEARCH PRIORITIES
FURTHER DURING THE BREAKOUT
SESSION THIS AFTERNOON.
THANK YOU VERY MUCH.
>> THANK YOU, DR. BRYANT, FOR
THAT EXCELLENT PRESENTATION.
I'D LIKE TO REMIND ATTENDEES TO
USE THE CHAT BOX TO MAKE
COMMENTS, WORKING GROUP
CO-CHAIRS WILL RESPOND DURING
THE BREAKOUT SESSION.
I'M PLEASED TO INTRODUCE DR.
TRIULZI AND JOSEPHSON,
OPTIMIZING TRANSFUSION,
OUTCOMES.
DR. TRIULZI IS IS UNIVERSITY OF
PITTSBURGH, EXPERTISE IN
TRANSFUSION AND CLINICAL TRIALS,
HELD NUMEROUS LEADERSHIP
POSITIONS IN PARTNERSHIP WITH
DR. SPITALNIK CO-CHAIRED THE
MOST RECENT STATE OF SCIENCE IN
TRANSFUSION MEDICINE SYMPOSIUM
IN 2015.
IT'S MY PLEASURE TO WELCOME DR.
CASSANDRA JOSEPHSON, DIRECTOR
FOR HEMATOLOGY ONCOLOGY AND
MEDICAL DIRECTOR OF TRANSFUSION
MEDICINE JOHNS HOPKINS AL
CHILDREN'S HOSPITAL, IN FLORIDA,
INVOLVED IN MEDICAL EDUCATION,
CLINICAL RESEARCH, LEADERSHIP
POSITIONS, WE WELCOME DR.
JOSEPHSON TO PRESENT RESEARCH
PRIORITIES FOR THE WORKING
GROUP.
>> THANK YOU, NAREG.
I'D LIKE TO THANK THE ORGANIZERS
FOR INVITING DR. TRIULZI AND
MYSELF TO CO-CHAIR THIS VERY
TALL ORDER TO FILL GROUP,
OPTIMIZING TRANSFUSION OUTCOMES
FOR RECIPIENTS, CLINICAL
RESEARCH, RCTs, PRAGMATIC
TRIALS, PATIENT BLOOD
MANAGEMENT, OBSERVATIONAL
EPIDEMIOLOGY.
I HAD TO ENLIST QUITE A FEW
PEOPLE, ONE OF WHICH WAS NOT
WRITTEN ON THIS SLIDE BUT WAS A
KEY MEMBER AND HELPED DR.
TRIULZI AND I CONSTITUTE THESE
DIFFERENT SUBGROUP MEMBERS,
NANCY AND HER CLINICAL EXPERTISE
AND CLINICAL RESEARCH EXPERT
DESIGN.
WE HAD TO FILL THESE SUBGROUPS
WITH EXPERTS AND WE TRIED TO GET
REPRESENTATION FROM TRANSFUSION
MEDICINE, ADULT AND PED HEM-ONC,
NEONATOLOGY, COMMUNITY LEADERS,
FAMILIES, MOMS, WE TRIED TO RUN
THE SPECTRUM SO WE COULD ADDRESS
EVERYTHING THAT WAS ASKED OF US.
WE HAD THESE SUBGROUPS CREATED
THAT FIRST WE THOUGHT WOULD
REPRESENT THE DIFFERENT
PRODUCTS, AND THEN AS WE
BROUGHT THE GROUP TOGETHER WE
NEEDED TO MANAGE ACUTE BLEEDING,
ENCOMPASSING THOSE PRODUCTS.
WE ALL QUICKLY DESIGNED FOR
SUBGROUP.
NEXT SLIDE.
WE THOUGHT WE WERE GOING TO HAVE
MANY GREAT IDEAS COME TO THE
FOREFRONT AND HOW WERE WE GOING
TO PRIORITIZE THOSE SO WE TRIED
IN A SCIENTIFIC WAY TO FIND A
PRIORITIZATION METHODOLOGY THAT
WE COULD EMPLOY.
AND THE CHILDREN'S HEALTH
NUTRITION RESEARCH INITIATIVE
HAD ACTUALLY VALIDATED A WAY TO
PUT PRIORITIES INTO ORDER AND IT
WAS SIMON AND MARY ANN TO
BROUGHT THIS TO OUR ATTENTION.
NEXT SLIDE PLEASE.
SO WHAT WE DID IS WE AS A GROUP
WERE SURVEYED AND WE LOOKED AT
THE TEN CRITERIA THAT THEY PUT
OUT AND SELECTED THE TOP --
SORRY, 20 PUT OUT AND SELECTED
THE TOP 10 AS A GROUP.
YOU CAN SEE WHAT REPRESENTATION
IS HERE, ANSWERABILITY TO
FEASIBILITY, WE JUST FELT LIKE
WE WERE GOING TO NEED SOME KIND
OF OBJECTIVE WAY TO DECIDE WITH
ALL OF THE PRIORITIES THAT WOULD
COME TO THE FOREFRONT.
YOU CAN SEE PROPOSAL BY THE
COMMITTEE, SO WE EMPLOYED THOSE
CRITERIA, AND THE TOP FIVE WERE
RED BLOOD CELL, ACUTE ANEMIA
MEASURES, PROPHYLACTIC PLATELET
TRANSFUSION, NON-HEMOSTATICS,
CHRONIC TRANSFUSION, BLEEDING
MANAGEMENT, NEXT FIVE STILL
IMPORTANT, NISHOT, COMPARING,
IMPLEMENTATION, AND COMPARING
PLASMA PRODUCTS.
NEXT SLIDE PLEASE.
PRIORITY NUMBER 1 WAS ANEMIA
MEASURES AND RED CELL
TRANSFUSION MAKING, WHAT ARE THE
OPTIMAL MEANS OF RED CELL
TRANSFUSION DECISION MAKING IN
THE SETTING OF ACUTE ILLNESS,
AND WE KNOW DURING ACUTE ILLNESS
RED CELL TRANSFUSION IS
INDICATED TO IMPROVE DELIVERY OR
RELIEVE BURDENS OF COMPENSATORY
ELEMENTS OF O2 DELIVERY SYSTEM.
WE'VE BEEN KIND OF PUT INTO A
BOX WITH LOOKING AT TRANSFUSION
TRIGGERS AND RESTRICTIVE RED
CELL TRANSFUSION STUDIES
FOCUSING ON ONE
ONE-SIZE-FITS-ALL OPTION, AND
LESS THAN 7 GRAMS PER DECILITER
HAVE BEEN OUR TRIGGER CHOICE BUT
WE KNOW THIS ONE DIMENSIONAL WAY
OF CHOOSING DOESN'T ACCOUNT FOR
VARIATION IN INDIVIDUAL
PHYSIOLOGY, AND SOME PATIENTS
MAY HAVE MORE PHYSIOLOGIC
RESERVE AND TOLERATE LOWER
LEVELS, OTHERS HAVE LESS
PHYSIOLOGIC RESERVE AND REQUIRE
HIGHER LEVELS.
AS A DISCIPLINE, OUR ABILITY TO
IMPROVE PATIENT OUTCOMES HAS
BEEN LIMITED BY THESE TYPE OF
STUDY DESIGNS.
SO THERE'S A NEED FOR
PERSONALIZED APPROACH BASED ON
NEW MEASURES OF OXYGEN DELIVERY
SYSTEMS, HOMEOSTASIS THAT
CORRELATES WITH CLINICAL
OUTCOMES.
NEXT SLIDE PLEASE.
SO WHAT IS THE ISSUE HERE?
CURRENT TRANSFUSION DECISION
MAKING IS ALWAYS BASED ON
HEMOGLOBIN CONCENTRATION AND
DOESN'T CONSIDER INTENSITY, AND
OTHER FACTORS INDEPENDENT OF
SEVERITY, THIS VARIES WIDELY
ACROSS AND WITHIN INDIVIDUALS
DUE TO CO-MORBIDITIES.
THERE'S LACK OF TRANSFUSION
MAKING DECISION STRUCTURE FOR
US, INDIVIDUALS FOR WHOM
PERMISSIVE ANEMIA IS UNSAFE SUCH
AS COMPENSATION IS UNSUSTAINABLE
AT ANY ABNORMAL HEMOGLOBIN, IN
SUCH PATIENTS WHERE GUIDELINES
GUIDE TRANSFUSION TIMING AND
AMOUNT.
RESULT IS BOTH OVERAND UNDER
UNDERTRANSFUSION AND RISK OF
ORGAN FAILURE.
UNDERTRANSFUSION ABOVE THIS
THRESHOLD OF 7, TRANSFUSION
RISKS UNDER 7, WE NEED NEW AND
BETTER MEASURES RATHER THAN
HEMOGLOBIN TO GUIDE OUR DECISION
MAKING TO IMPROVE OUTCOMES.
WHY IS THIS AN ISSUE?
WHAT IS THE PROPOSED APPROACH?
TRANSFUSION DECISION MAKING
REQUIRES IMPROVED
UNDERSTANDINGS, OF SUSTAINABLE
PHYSIOLOGIC COMPENSATION, ANEMIA
TOLERANCE, ABILITY TO IDENTIFY
SPECIFIC VITAL ORGANS AT RISK
FOR ISCHEMIA, WHEN GLOBAL 02
DELIVERY HOMEOSTASIS IS
MAINTAINED.
A PERSONALIZED APPROACH NEEDS TO
BE USED AND IS NOT ONLY GOING TO
BE BASED ON THE SEVERITY OF THE
ANEMIA BUT INTENSITY AND
SUSTAINABILITY TO COMPENSATE.
SO DIFFERENCES IN NATIVE AND
DONOR RED CELL PHYSIOLOGY AS
WELL AS TRANSFUSION
TRANSFUSION.
REQUIRES PERSONALIZED INDICATORS
OF COMPENSATION, CANDIDATES FOR
THIS COULD BE FOR GLOBAL OR
VITAL ORGANS SPECIFICALLY SO
BEDSIDE VO2, O2 CONSUMPTION
MEASURES, USE OF NOVEL
BIOMARKERS, INJECTABLE REPORTER
MOLECULES REFLECTING TISSUE
LEVELS, BIOCHEMICAL CUES OF
DELIVERY.
THERE NEED TO BE NOVEL
MONITORING DEVICES,
COMPUTATIONALLY DERIVED METRICS.
NEXT SLIDE PLEASE.
FEASIBILITY AND BARRIERS ARE
QUITE SUBSTANTIAL HERE BECAUSE
WE DON'T HAVE MUCH TO SUPPORT
DATA-WISE USE OF PHYSIOLOGIC
STRATEGIES AND SEEMS TO BE NO
CONSENSUS ON GOALS TARGETED.
SOME CANDIDATE METHODS EXIST AND
CAN BE STUDIED IN CLINICAL
SETTING SUCH AS WITH NIRS,
BEDSIDE VO2, BLOOD BIOMARKERS,
COMPUTED METRICS FROM
PHYSIOLOGIC DATA STREAMS, HEART
RATE, VARIABILITY INDEXING,
NOVEL DEVICE DEVELOPMENT
REQUIRES SUSTAINABILITY
STABILITY OF DELIVERY, GUIDING
THE TIMING, AMOUNT, RESPONSE TO
TRANSFUSION.
TRANSFUSION DECISION MAKING
DEVELOPMENT MAY BE FACILITATED
VIA BAYESIAN MODELING,
APPLICATION OF DYNAMICS,
DEVELOPMENT OF EHR EMBEDDED
COMPUTERIZED TOOLS AND THIS IS
POSSIBLY WITH REALTIME
ARTIFICIAL INTELLIGENCE AND
MACHINE LEARNING APPLICATIONS,
MEASURED TO REPORT GLOBAL HOMEO
TASTE IS. -- HOMEOSTASIS.
PROPHYLACTIC PLATELET
TRANSFUSION, WHAT IS THE OPTIMAL
USE IN CLINICAL SETTING?
WE'RE LOOKING AT CRITICAL
ILLNESS, SURGERY, EXTRACORPOREAL
SUPPORT, PATIENTS ON
ANTIPLATELET THERAPIES, HOW DO
DONOR CHARACTERISTICS SUCH AS
PRODUCT STORAGE, ABO
COMPATIBILITY AND PHYSIOLOGY,
RISK STRATIFICATION INFLUENCE
THIS OPTIMAL USE.
I THINK EVERYBODY IN THIS
AUDIENCE IS AWARE WE'VE LOOKED
AT UP AND DOWN PROPHYLACTIC
PLATELET TRANSFUSION IN
MALIGNANCIES BUT HAVEN'T DEFINED
IT IN OTHER REALM.
THIS IS A MAJOR SOURCE OF LACK
OF GUIDANCE FOR TRANSFUSING
PATIENTS.
NEXT SLIDE PLEASE.
SO WHAT IS THE ISSUE?
THE ISSUE IS THERE'S NO EVIDENCE
IN ADULT AND PEDS, VERY LITTLE
IN SETTING OF CRITICAL ILLNESS,
NEED FOR SURGERY, AND
NON-HEMATOLOGIC MALIGNANCIES SO
WHEN WE SHOULD USE PROPHYLACTIC
PLATELET TRANSFUSION.
THERE'S RISK OF USING PLATELETS
AND NOT UNDERSTANDING WHAT THEIR
BENEFITS ARE AND WE KNOW
PLATELET COUNT DOES NOT
CORRELATE WITH BLEEDING RISK.
USING THAT ONE DIMENSIONAL
TRIGGER IS PROBABLY INCORRECT.
THE USE OF PLATELET COUNT TO
MAKE TRANSFUSION DECISIONS
DOESN'T ACCOUNT FOR ADDITIONAL
DONOR AND RECIPIENT
CHARACTERISTICS THAT MAY BE
RELEVANT FOR DETERMINING RISK OF
BLEEDING OR RISKS ASSOCIATED
WITH TRANSFUSION OF PLATELET
COMPONENTS.
I MENTIONED DONOR FACTORS.
THERE ARE RECIPIENT FACTORS,
THAT'S WHY THESE DIFFERENT
RECIPIENT POPULATIONS NEED TO BE
LOOKED AT INDIVIDUALLY,
COMORBIDITIES, PLATELET
FUNCTION, LOCATION OF THE
POTENTIAL BLEED AND TYPE OF
INTERVENTION WHERE SUPPORT HAS
TO BE CONSIDERED WHEN GIVING A
PLATELET TRANSFUSION.
GLOBAL MEASURES OF HOMEOSTASIS
MAY ALLOW FOR RISK
STRATIFICATION INCLUDING TAKING
ANTIPLATELET MEDICATION OR
EXTRACOREPOREAL CIRCUIT.
WE NEED MORE RESEARCH TO ADDRESS
THE QUESTIONS.
RANDOMIZED CONTROLLED TRIALS
NEED TO BE PUT IN PLACE, TRIAL
DESIGN NEEDS TO BE CALLED UPON
BECAUSE SOME POPULATIONS ARE
MUCH SMALLER AND TO BE ABLE TO
CREATE TRANSFUSION GUIDELINES WE
NEED TO BE ABLE TO STUDY THESE
SMALLER PATIENT POPULATIONS.
ANIMAL MODELS AND TRANSLATIONAL
STUDIES TO DEFINE DONOR AND
RECIPIENT CHARACTERISTICS FOR
PROPHYLACTIC PLATELET
TRANSFUSION ARE NECESSARY,
ADDITIONAL MEASURES NEED TO BE
ASSESSED.
SYSTEMS BIOLOGY STUDIES AND
LEVERAGING ANALYTIC APPROACHES
SUCH AS AUTOMATED ARTIFICIAL
INTELLIGENCE MODELING PLATFORMS
WILL BE NEEDED TO BE ABLE TO
INTEGRATE ALL THAT DATA.
NEXT SLIDE PLEASE.
SO FEASIBILITY AND BARRIERS
IT IS FEASIBLE TO DO SOME
STUDIES, MORE CREATIVE TO COME
UP IN THESE SPECIAL POPULATIONS.
STUDIES LINKING PRE-CLINICAL
DATA AND METADATA MAY HELP YIELD
NEW INSIGHTS INTO THIS ISSUE
WITHOUT STUDYING THOUSANDS OF
PATIENTS SUCH AS WERE NEEDED IN
TRADITIONAL TRIALS.
IT MAY BE DIFFICULT TO ENROLL
ENOUGH SO POWERING LARGER
STUDIES MAY BECOME AN ISSUE AND
THAT TRANSLATES TO MORE
EXPENSIVE STUDIES THAT MAY NEED
TO GO ON BEYOND FIVE YEARS.
ADAPTIVE TRIAL DESIGN STRATEGIES
COULD BE HELPFUL HERE.
NUMBER 3, TRANSFUSION, WHAT ARE
EFFECTS ON HEMOSTATIC AND
NON-HEMOSTATIC PROCESSES SUCH AS
IMMUNE FUNCTION, INFLAMMATION,
ANGIOGENESIS AND MECHANISMS THAT
MEDIATE IN RECIPIENTS OF
DIFFERENT AGES GOING FROM
EXTREMELY PRE-TERM INFANTS TO
OLDER ADULTS, WITH VARIABLE
UNDERLYING CONDITIONS SUCH AS
CRITICAL ILLNESS,
IMMUNOCOMPROMISED, HAVING
CANCER.
WE NEED TO ANSWER WHAT IS GOING
ON IN SOME TRIALS ESPECIALLY THE
ONE IN NEONATES, DYING OR MORE
SICK WITH MORE PLATELETS GIVEN
FOR HEMOSTATIC REASONS,
MECHANISMS LEADING TO INCREASES
IN MORBIDITY AND MORTALITY IN
SELECT PATIENT PLATELET
TRANSFUSION RECIPIENTS SEEM TO
BE RELATED TO OFF TARGET OR
NON-HEMOSTATIC EFFECTS, VITAL TO
UNDERSTAND WHETHER AND HOW THEY
ARE MODULATED BY DIFFERENT
PRODUCT TREATMENT CONDITIONS
CRITICALLY IS IMPORTANT TO
APPRAISE RISK/BENEFIT RATIO OF
PLATELETS AND OTHER PRODUCTS
SUCH AS PLASMA TRANSFUSION IN
PATIENT POPULATIONS.
ARE THESE OFF-TARGET REASONS --
PLATELETS ARE CRITICAL
REGULATORS OF NON-HEMOSTATIC
PROCESSES PARTICULARLY IN INNATE
REALM, INFLAMMATION,
ANGIOGENESIS.
MAJORITY OF GENES IN PLATELETS
REGULATE IMMUNE PROCESS RATHER
THAN HEMOSTASIS.
THERE ARE FUNCTIONS IN ADDITION
TO HEMOSTATIC FUNCTIONS
PLATELETS INTERACT WITH IMMUNE
AND VASCULAR CELLS DIRECTLY AND
INDIRECTLY, SO IT'S SO IMPORTANT
TO HAVE ANIMAL MODEL DESIGNS TO
EVALUATE THE NON-HEMOSTATICS
FUNCTIONS IN INFECTION,
TRANSPLANTATION, CANCER,
RETINOPATHY, PLATELETS ENHANCE
THE DISEASE IN SOME CASES,
ATTENUATE IN OTHERS, DEPENDING
ON THE SPECIFIC MODEL BEING
USED.
NEXT SLIDE PLEASE.
SO WHAT IS THE PROPOSED
APPROACH?
TRANSLATIONAL STUDIES NEED TO
LOOK AT PATIENT POPULATION AND
CONDITIONS, BIOBANKING AND
ADDRESSING RESEARCH QUESTIONS
COULD BE INCORPORATED.
STATE-OF-THE-ART TECHNOLOGY SUCH
AS SINGLE CELL RNAseq TO BE
IMPLEMENTED TO CHARACTERIZE
MOLECULAR EFFECTS.
GIVEN CURRENT TRENDS, IT'S GOING
TO BE A LOT MORE DIFFICULT, SO
HUMAN STUDIES WILL NEED TO BE
REQUIRED TO BE MULTI-CENTER IN
APPROACH.
NEXT SLIDE PLEASE.
FEASIBILITY AND BARRIERS
ADDRESSING THIS COMPLEX QUESTION
IS GOING TO REQUIRE COMBINATION
OF STUDIES USING SYSTEM BIOLOGY
APPROACH AND INCORPORATING
ANIMAL MODELS OF DISEASE AND THE
STUDIES IN HUMANS.
PUBLISHED WORKS SUGGEST EFFECTS
ARE DIFFERENT BASED ON
DEVELOPMENTAL STAGE, CRITICAL TO
UNDERSTAND EVEN PRE-TERM VERSUS
TERM NEONATES VERSUS CHILDREN
VERSUS ADULTS.
NEXT SLIDE PLEASE.
NUMBER 4, RED CELL THERAPY, WHAT
ARE OPTIMAL TRANSFUSION
STRATEGIES FOR OUTPATIENTS
REQUIRING TRANSFUSION THERAPY?
RED CELL TRANSFUSION STUDIES,
NEARLY 30% OF TRANSFUSIONS OCCUR
OUTSIDE THE OUTPATIENT SETTING.
WE CAN'T APPLY WHAT'S LEARNED IN
THE HOSPITAL TO OUTPATIENTS,
TRANSFUSION NEEDS ARE OVER AND
EXTENDED PERIOD.
CLINICAL STUDIES ARE NEEDED TO
DEFINE OPTIMAL TRANSFUSION
DECISION MAKING STRATEGIES AND
WE LACK CONDITION OR
PATIENT-SPECIFIC METRICS FOR
LOOKING AT HEMATOPOIESIS.
NEXT SLIDE PLEASE.
WHAT IS THE ISSUE?
I ALREADY EXPLAINED IT BUT THERE
ARE DIFFERENT GROUPS OF PATIENTS
THAT REQUIRE RED CELL
TRANSFUSION CHRONICALLY IN
OUTPATIENT SETTING.
SICKLE CELL DISEASE COMES TO
MIND, BUT ALSO QUALITY OF LIFE
BENEFITS, PERFORMANCE STATUS
SUCH AS MDS ARE IMPORTANT.
PROLONGED TRANSFUSION IS
ASSOCIATED WITH RISK.
SIGNIFICANT RESOURCES ARE
REQUIRED TO MEET NEEDS OF
DEPENDENT PATIENTS.
WE LOOK AT RED CELL ANTIBODY
IDENTIFICATION WORKUPS HERE, RED
CELL ANTIGEN MATCHING FOR MORE
FREQUENT UNITS, AND SICKLE CELL
DISEASE DESK FOR PATIENTS WITH
SICKLE CELLS, MAKING SURE
THERE'S NOT SICKLE CELLS IN
TRANSFUSED UNITS, LACK OF RCT
DEFINING OPTIMAL DECISION
MAKING STRATEGIES IN OUTPATIENT
SETTING.
WHAT'S THE PROPOSED APPROACH?
LOOKING AT RCTs TO DEFINE
OPTIMAL TRANSFUSION SUPPORT FOR
DISTINCT POPULATIONS REQUIRING
THERAPY TO EVALUATE AND
IMPLEMENT NATIONAL REGISTRIES TO
DOCUMENT TRANSFUSION
INFORMATION, INCLUDING RED CELL
IMMUNIZATION, GENOTYPE,
PHENOTYPE, STUDIES TO DEIMPACT
IMPACT OF COMMON COMPLICATIONS.
STUDIES TO DEFINE FUNDAMENTAL
RISK FACTORS.
AND THEN CLINICAL AND
PRE-CLINICAL TRANSLATIONAL
INVESTIGATION INCLUDING KEY
DONOR CHARACTERISTICS TO DEFINE
FACTORS THAT INFLUENCE SURVIVAL
OF TRANSFUSED RED CELLS THERE BY
REDUCING ALLOGENEIC EXPOSURE AND
CONSEQUENCES AS WELL AS
EFFECTIVE TRANSFUSION UPON
GENESIS AND CLEARANCE OF NATIVE
CELLS.
FEASIBILITY/BARRIERS, LARGE
NUMBER OF TRANSFUSE THE
OUTPATIENTS LIKE I SAID NEARLY
30%, NATIONAL DATABASES AND
REGISTRIES, ADVANCING ABILITY TO
PERFORM RED CELL GENESIS,
RECOVERY AND SURVIVAL STUDDIES,
GOING TOOL OF BIOTIN LABELING,
AND GOALS AND ENDPOINTS WILL
DELIVER BY POPULATION, AND
LOOKING AT QUALITY OF LIFE
MEASURES AND PHYSIOLOGIC
CAPACITY.
NEXT SLIDE PLEASE.
BLEEDING MANAGEMENT WITH
MULTIPLE COMPONENTS, THE
QUESTION HERE IS WHICH BLOOD
PRODUCTS, WHOLE OR COMPONENT
ALONE OR COMBINATION,
INTRAVENOUS, TOPICAL,
HEMOSTATICS, ARE MOST EFFECTIVE
AND SAFE TO TREAT BLEEDING IN
THE PRE-HOSPITAL AND HOSPITAL
SETTING INCLUDING DIFFERENT
CONDITIONS ASSOCIATED WITH
BLEEDING SUCH AS INTRACRANIAL,
G.I., SURGICAL, TRAUMA, ALSO
TAKING INTO CONSIDERATION
CLINICAL AND COST EFFECTIVENESS
OUTCOMES, STUDYING COMBINATIONS
TO OPTIMIZE OUTCOMES.
INSTEAD OF COMPARING ONE TO
ANOTHER WE ARE ABLE TO COMPARE
COMBINATION WE WOULD USE REALLY
IN REAL WORLD SITUATION TO TREAT
TRAUMA IN DESIGNING STUDIES THAT
WAY.
WHY IS IT AN ISSUE?
MORBIDITY AND MORTALITY IS HIGH,
24%, 50%, MORTALITY IN TRAUMA
AND ABOVE 60% FOR CHILDREN WITH
MEDICAL ETIOLOGY OF BLEEDING,
NOT MANY TRIALS CAN INFORM BEST
PRACTICE SO WE NEED TO CREATE
THEM IN THE FUTURE.
RELATIVE TO ALL OTHER CONDITIONS
THAT REQUIRE TRANSFUSION
PATIENTS WITH SEVERE BLEEDING
FROM ALL CAUSES HAVE THE WORST
OUTCOMES WITH HIGHEST POTENTIAL
FOR IMPROVEMENT IN OUTCOMES
SINCE THE RATE OF PREVENTIBLE
DEATH FROM BLEEDING IS HIGH.
IT'S ESTIMATED THAT FROM TRAUMA
ALONE THERE'S 30,000 PREVENTIBLE
DEATHING PER YEAR IN THE U.S.ING
SO RESEARCH ON STRATEGIES AND
BLEEDING PATIENTS SHOULD RECEIVE
HIGHEST PRIORITY ACCORDING TO
THIS GROUP.
AND SINCE THERE'S THE MOST TO
GAIN IN THIS POPULATION.
MULTIOMICS ANALYSES HAVE BEEN
ABLE TO IDENTIFY DISTINCT
BIOLOGIC RESPONSES AND THEY ARE
PREDICTIVE OF WHICH COHORT WILL
HAVE IMPROVED SURVIVAL WITH
CERTAIN THERAPIES.
USING PRECISION TRANSFUSION
MEDICINE THERAPY.
FOR EXAMPLE, PRE-HOSPITAL PLASMA
IMPROVED SURVIVAL IN PATIENTS
WITH PRO-INFLAMMATORY ENDOTYPE
WITH TRAUMATIC BRAIN INJURY.
NEXT SLIDE PLEASE.
WHAT IS THE PROPOSED APPROACH?
ADAPTIVE TRIAL DESIGN THAT
INCLUDE PLATFORM TRIALS COULD BE
CONSIDERED TO FACILITATE THE
STUDY OF COMBINATIONS AND
INCLUDE OTHER DESIGNS.
ALL OF THOSE PLATFORM TRIALS
COULD INCLUDE WHAT IS BELOW, FOR
INSTANCE COMPARING INDICATIONS
FOR PRODUCTS SUCH AS GOAL
DIRECTED THERAPIES, VISCOELASTIC
TESTING, MICROFLUIDIC FLOW-BASED
ASSAYS, COMPARING HOW BLOOD
COMPONENTS MANUFACTURING METHODS
AFFECT EFFICACY AND SAFETY, USE
FOR BLEEDING SUCH AS ROOM
TEMPERATURE, USE OF HEMOSTATIC
AGENTS, BIOLOGIC DATA REGARDING
OXYGEN DELIVERY, IMMUNE FUNCTION
TO ALLOW FOR USING MULTIOMIC
PLATFORMS FOR RESPONSE TO
BLEEDING AND BIOLOGIC RESPONSE
TO THERAPEUTIC MODALITIES, USE
OF IMPLEMENTATION SCIENCE, TO
LOOK AT IMPROVING BLEEDING IN
THESE PATIENTS, AND FINALLY
METHODS TO ALLOW FOR EXAMINING
THE GENERATION AND ACCURACY OF
BLEEDING SCORES THAT PREDICT USE
AND CORRELATE WITH CLINICAL
OUTCOMES THAT ARE ALSO FEASIBLE
AND REPRODUCIBLE.
NEXT SLIDE PLEASE.
THERE ARE ISSUES BUT MOSTLY
TRIALS IN BLEEDING PATIENTS HAVE
BEEN SUCCESSFULLY PERFORMED
RECENTLY, PRE-HOSPITAL, WITH
EXCEPTION FOR INFORMED CONSENT
AND PLATFORM TRIALS WHERE
BASIS -- MANY WERE BASED OFF
WHAT WAS DONE DURING COVID-19
TRIALS.
IT'S FEASIBLE TO INCORPORATE
PLATFORM TRIALS THAT REQUIRE
EFIC BASED ON ETHICAL
PRINCIPLES.
SO AS I MENTIONED THERE WERE
FIVE MORE TRIALS THAT REALLY
WERE GIVEN MUCH, MUCH THOUGHT
AND CONSIDERATION AND CAN BE
DISCUSSED IN THE BREAKOUT
SESSION AS WELL.
AND THEY WERE LOOKING AT RED
BLOOD CELL NISHOTS, RISK AND
OPTIMAL APPROACHES,
CRYOPRECIPITATE VERSUS
FIBRINOGEN CONCENTRATE, AND
CRYOPRECIPITATE VERSUS PLASMA,
HOW CAN WE PATIENTS WHO REQUIRE
PLASMA TRANSFUSION OR FIBRINOGEN
REPLACEMENT, THERE'S STEWARDSHIP
AND IMPLEMENTATION SCIENCE,
STRATEGIES TO OPTIMIZE BLOOD
PRODUCT STEWARDSHIP TO EVALUATE
AND DISSEMINATE AND COMPARING
PRODUCTS, IS ONE SUPERIOR,
TREATMENT OF NON-BLEEDING
PATIENTS PRIOR TO INVASIVE
PROCEDURES OR BLEEDING PATIENTS
IN TERMS OF EFFICACY, SAFETY,
LOGISTICS, OR SPECIFIC PATIENT
POPULATIONS.
NEXT SLIDE PLEASE.
>> TWO-MINUTE WARNING.
>> THESE ARE THE PRIORITY
SUMMARY, PRIORITIES SUMMARIZED,
AND YOU CAN GO BACK TO SEE SLIDE
27 TO GO FLEW SOME DETAILS OR
BACK TO WHAT YOU'VE BEEN
SUPPLIED TO READ PRIOR TO THIS.
NEXT SLIDE PLEASE.
AND LAST BUT NOT LEAST, WE CAN
RELEASE THESE FROM THE SLIDES, I
DON'T THINK THIS WAS INCLUDED
WHEN YOU GOT YOUR INFORMATION
PRIOR TO THE STATE OF THE
SCIENCE BUT THIS IS HOW WE WENT
THROUGH AND RATED EACH PRIORITY
AND CAME TO OUR TOP FIVE AND OUR
SECOND FIVE.
SO WITH THAT, I THANK YOU FOR
YOUR ATTENTION AND WE'LL
ENTERTAIN QUESTIONS IN THE CHAT
BOX DURING THE BREAKOUT SESSION.
THANK YOU.
>> THANK YOU, DR. JOSEPHSON.
AN AMAZING AMOUNT OF MATERIAL TO
COVER IN JUST UNDER 30 MINUTES,
VERY MUCH APPRECIATED AND LOTS
OF POINTS FOR DISCUSSION.
FOR NOW WE WILL MOVE ON TO OUR
NEXT WORKING GROUP, EMERGING
INFECTIONS, IMPACT ON BLOOD
SCIENCE, THE SUPPLY, SAFETY, AND
PUBLIC HEALTH.
CHAIRS ARE DR. EVAN BLOCH AND
LOUIS KATZ.
DR. BLOCH IS LEADING US THROUGH
THE CONTENT TODAY.
>> OKAY.
FIRST, SINCERE THANKS TO NHLBI,
ORGANIZING COMMITTEE, BRIAN AND
NAREG.
OUR FOCUS IS EMERGING INFECTION.
A CONCEPT PRESENTED BY MYSELF
AND MY CO-MODERATOR, DR. LOUIS
KATZ, IS CREDITED COULD THE
EFFORT OF THE MEMBERS OF THE
WORKING GROUP ACKNOWLEDGED AT
THE END.
AS WE GO THROUGH THE SLIDES, THE
PRIORITIES ARE NOT NUMBERED SO
DIFFERENT FROM THE PRIOR TWO
PRESENTATIONS.
THIS WAS INTENTIONAL.
WE EACH HAVE OUR BIASES AND
PREFERENCES, SO WE'VE LEFT THE
FINAL RANKING TO THE BREAKOUT
SESSION, WE DO KNOW WHAT THE
INDIVIDUAL MEMBERS, WHAT THEY
WOULD LIKE TO SEE.
NEXT SLIDE PLEASE.
SO, A WORD ABOUT EMERGING
INFECTIOUS DISEASES, ENCOUNTERED
MUCH MORE FREQUENTLY THAN
APPRECIATED, WE CAN LOOK AT THE
PAST TWO YEARS JUST TO GET A
FINE APPRECIATION FOR THE IMPACT
OF EMERGING INFECTIOUS DISEASES,
WE'RE IN THE MIDST OF AN
HISTORIC COVID-19 PANDEMIC AS
WELL AS MONKEYPOX PANDEMIC, OR
CRISIS OF INTERNATIONAL CONCERN,
DEPENDING HOW YOU WANT TO PHRASE
IT.
MULTIPLE AND DIVERSE
CONTRIBUTING FACTORS WHY THERE
IS INCREASED ESCALATION IN
EIDs, AND THEY ARE BOTH DIRECT
AS INDIRECT EFFECTS ON THE BLOOD
SUPPLY INDEPENDENT OF WHETHER A
GIVEN PATHOGEN IS ULTIMATELY
DEEMED TO BE TRANSFUSION
TRANSMISSIBLE.
NEXT SLIDE PLEASE.
SO, FIRST PRIORITY WHICH I'LL BE
DISCUSSING IS LEVERAGE DONOR
POPULATION TO STUDY EPIDEMIOLOGY
AND PATHOGENESIS OF TTIs AND
EIDs TO OPT MICE USE OF
POPULATION.
BLOOD DONORS OFFER OPPORTUNITIES
FOR STUDY OF INFECTIOUS DISEASE.
NEXT SLIDE PLEASE.
WHY IS THIS AN ISSUE?
WELL, IT'S NOT REALLY AN ISSUE.
IT'S AN OPPORTUNITY.
BLOOD DONORS ARE LARGE
DEMOGRAPHICALLY DIVERSE SUBSETS
OF THE GENERAL POPULATION.
THEY ARE GENERATING
CROSS-SECTIONAL AS WELL AS
LONGITUDINAL SAMPLES, LEVERAGED
FOR RESEARCH.
THE DATA AFFORD INSIGHT INTO
TRANSFUSION TRANSMITTED
INFECTION AND EMERGING
INFECTION.
THERE'S NUMEROUS EXAMPLES WHERE
DATA HAVE BEEN USED SUCCESSFULLY
TO ADVANCE OUR UNDERSTANDING OF
VARIETY OF INFECTIOUS DISEASES.
SEMINAL WORK ON HEPATITIS THAT
ARE WIDE REACHING, THOSE
FINDINGS WERE WIDE REACHING,
ADVANCING UNDERSTANDING OF
HEPATITIS B AS WELL AS HEPATITIS
C AND INTERVENTIONS THAT WE KNOW
IS ROUTINE IN BLOOD BANKING
ATTRIBUTED TO SOME OF THAT WORK.
LONGITUDINAL STUDY OF HIV
INFECTED DONORS AND RECIPIENTS
HAS INFORMED THE VIRAL AND
IMMUNOLOGICAL DYNAMICS DURING
ACUTE AND EARLY INFECTION.
SO THAT'S BEEN USED,
INCORPORATED INTO DIFFERENT
STAGING SYSTEMS.
IT'S YIELDED NOVEL CONCEPTS
SURROUNDING TRANSMITTED AND
FOUNDER VIRUSES.
WHAT'S THE PROPOSED APPROACH?
REALLY TO EXTEND EPIDEMIOLOGICAL
AND PATHOGENESIS RESEARCH IN
DONORS TO OTHER AGENTS.
IT'S ALREADY BEEN UNDERTAKEN FOR
A VARIETY OF PATHOGENS, HTLV,
ARBOVIRUS, PARASITES, AND FOR
EMERGING OUTBREAKS COMBINING TO
PROVIDE ESTIMATES OF POPULATION
INFECTIOUS RATES.
ALSO TO CONDUCT DONOR FOLLOW-UP
STUDIES WHERE WE CAN EXAMINE
IMMUNE RESPONSE DYNAMICS,
CORRELATE THOSE FINDINGS WERE
SYMPTOMS, AGAIN EXAMPLE OF
RECENT, YOU KNOW, RECENT EXAMPLE
WHERE THIS HAS BEEN UNDERTAKEN
SUCCESSFULLY DONOR SURVEILLANCE
STUDIES OF SARS-COV-2, YIELDED
ESTIMATES OF BURDEN OF
INFECTION, VACCINATION RATES,
COMPARED WITH CLINICAL CASE
RATES ENABLE ESTIMATES OF
INFECTION INCLUDING VACCINE
BREAKTHROUGH, REINFECTION,
DISEASE PENETRANCE.
NEXT SLIDE PLEASE.
WHAT'S THE FEASIBILITY OF
BARRIERS?
FEASIBLE, WE DISCUSSED A FEW
HIGH YIELD CONTRIBUTIONS, BUT
THE CHALLENGES RELATE TO
ESTABLISHING SUSTAINABILITY,
SUSTAIN ANALYSIS ITEMS FOR
REPOSITORIES AND RESEARCH
PROGRAMS, THE APPROACH HAS BEEN
BASED ON AD HOC PROPOSALS AND
SHORT-TERM FUNDING STREAMS.
HIGH PRIORITY ACTIVITIES INCLUDE
REALLY BUILDING SUSTAINABLE
CAPACITY, IDEALLY NEAR REAL TIME
RESPONSE TO POTENTIAL EID, ONE
NEEDS SYSTEMS TO CAPTURE
DONATION SAMPLES, CHARACTERIZE
MOLECULAR AND SEROLOGICAL
MARKERS TO ESTABLISH INCIDENCE
AND PREVALENCE OF INFECTION,
LONGITUDINAL FOLLOW-UP OF DONORS
FOR NATURAL HISTORY, AND
PATHOGENESIS STUDIES, SAMPLES
CAPTURE POST-DONATION
INFORMATION AND REPEAT DONOR
COHORT REPOSITORIES AND SUPPORTS
EFFORTS WHICH ARE ALREADY
UNDERWAY SO AGAIN GOING BACK TO
SARS-COV-2, THERE'S A LOT WHICH
CAN BE DONE WITH EPIDEMIOLOGY
AND PATHOGENESIS RESEARCH, AND
AS WELL AS ADVANCING THINGS TO
RAPID RESPONSES TO NEW EIDs
BASED ON TARGETING INVESTIGATION
OF DIFFERENT REPOSITORIES.
TO CONTINUE MOLECULAR
SURVEILLANCE OF INCIDENCE
INFECTION USING EXTANT
MECHANISMS SUCH AS REDS AND
TTIMS.
QUESTION IS HOW CAN PATHOGEN
REDUCTION OR PR BE INTEGRATED
INTO ROUTINE BLOOD TRANSFUSION
OPERATIONS TO OPTIMIZE BLOOD
SAFETY WHILE PRESERVING POTENCY?
CONVENTIONAL PARADIGM OF TEST
DEVELOPMENT IS SUBOPTIMAL, WHEN
CONTENDING WITH EMERGING,
REEMERGING, NOVEL PATHOGENS.
NEXT SLIDE PLEASE.
IT'S LOOKING AT A REACTIVE
VERSUS PRO-ACTIVE RESPONSE, THE
CONVENTIONAL PARADIGM OF TEST
DEVELOPMENT IS REACTIVE, A PIECE
VIEWED AS PRO-ACTIVE, INCLUDING
PATHOGENS WHICH SCREENING IS
ROUTINE, MAJOR TTIs, AGENTS
KNOWN TO BE TRANSMISSIBLE BUT
SCREENING IS NOT AVAILABLE FOR
ONE REASON OR ANOTHER.
WITH RESPECT TO TESTING, WHICH
IS THE CURRENT PARADIGM, THE
PACE OF TEST DEVELOPMENT IS
UNMATCHED.
THERE ARE REGULATORY AND
ADMINISTRATIVE BARRIERS TO TEST
DEVELOPMENT, QUALIFICATION
IMPLEMENTATION.
WE LOVE TO BLAME REGULATORS BUT
SOME OF THAT IS INHERENT TO A
NEW PATHOGEN.
THESE THINGS TAKE TIME.
DURING THAT TIME OF TEST
DEVELOPMENT, TRANSFUSION
TRANSMISSION, IS POTENTIALLY
GOING UNINTERRUPTED.
SO P.R. OFFERS A PRO-ACTIVE
STRATEGY, AVOIDS INTERVENTION.
ANCILLARY BENEFITS AS WELL, ONE
COULD EXTEND PRODUCT SHELF LIFE,
WHICH WOULD REDUCE WASTE AND
PRESERVE SAFETY, IF YOU THINK
ABOUT BACTERIAL CONTAMINATION
AND PLATELETS.
KIND OF MY NEXT STATEMENT IS
IRONIC, COULD DEFRAY COST OF
INFECTIOUS TESTING, WHICH IS
PLACING STRAIN ON TRANSFUSION
SERVICES AND I'LL GET TO THAT IN
A SUBSEQUENT SLIDE.
AND P.R. COULD REPLACE
IRRADIATION OF SELECTIVE
TECHNOLOGIES HAVE BEEN SHOWN TO
BE EFFECTIVE IN PREVENTING
TRANSFUSION-ASSOCIATED
GRAFT-VERSUS-HOST DISEASE.
NEXT SLIDE PLEASE.
THE PROPOSED APPROACH BROADLY IS
RESEARCH TO ADVANCE PR BY
REFINING CURRENT METHODS, AS
WELL AS DEVELOPING NEW
TECHNOLOGIES, SPECIFICALLY FOR
WHOLE BLOOD AND RED CELLS.
AND THERE ARE MECHANISMS TO DO
THIS, COULD SHALL ACCOMPLISHED
THROUGH INDUSTRY PARTNERSHIPS,
SPECIFICALLY SBIR FUNDING, AND
INDEPENDENCE ASSESSMENTS OF
RISKS AND COST/BENEFITS OF
IMPLEMENTATION OF P.R.
NEXT SLIDE PLEASE.
SO FEASIBILITY OR BARRIERS,
MAJOR BARRIER AT THE MOMENT IS
THAT THERE'S NO APPROVED
TECHNOLOGIES FOR TREATMENT OF
WHOLE BALLOONED RED CELLS IN THE
U.S.
RED CELLS ARE MOST COMMONLY
TRANSFUSED, THAT BARS UNIVERSAL
ADOPTION OF P.R. AT THE MOMENT.
AS COMPARED TO UNTREATED
PRODUCTS, P.R. IS HIGH COST AND
THE PREVIOUS SLIDE SAID IT COULD
DEFRAY COST, BUT AT THE MOMENT
IMPLEMENTATION IS VIEWED AS
INCREMENTAL COST, SO
IMPLEMENTATION MIGHT BE VIEWED
MORE FAVORABLY IF P.R.
TECHNOLOGIES WERE ALLOWED TO
REPLACE COMPETING INTERVENTIONS
BUT THAT REALLY NEEDS TO BE
UNDERSTOOD MORE HOW THAT COULD
BE INTEGRATED BETTER.
THERE'S ALSO UNCERTAINTY ABOUT
THE LONG-TERM SAFETY EFFECTS OF
SELECTIVE TECHNOLOGIES.
NEXT SLIDE PLEASE.
THE THIRD PRIORITY IS A
FRAMEWORK FOR RAPID OR RIGOROUS
INTRODUCTION OF PASSIVE ANTIBODY
BASED THERAPIES.
SPECIFICALLY HOW CAN BLOOD
PRODUCTS AND DERIVATIVES SUCH AS
CONVALESCENT PLASMA BE PRODUCED
FOR EMERGING INFECTIOUS
DISEASES, SO DESPITE WIDESPREAD
USE OF THERAPIES DURING THE
COVID-19 PANDEMIC, THERE'S
REALLY NUMEROUS QUESTIONS THAT
REMAIN.
EVERYTHING FROM MECHANISM OF
ACTION, OPTIMAL DOSAGE, CLINICAL
USE.
NEXT SLIDE PLEASE.
SO WHY IS IT AN ISSUE?
WHAT IS CONVALESCENT PLASMA?
IT'S COLLECTED FROM INDIVIDUALS
WHO RECOVERED FROM A GIVEN
INFECTION, VACCINATED AND
DEVELOPED ANTIBODIES AGAINST A
PATHOGEN OF INTEREST.
IT'S AN ATTRACTIVE THERAPY FOR
USE AGAINST EIDs, PARTICULARLY
EARLY IN AN OUTBREAK WHEN
PREVENTIVE STRATEGIES SUCH AS
VACCINES OR TREATMENTS SUCH AS
DIRECT ACTING ANTI-VIRALS,
MONOCLONALS, UNLIKELY TO BE
AVAILABLE.
THERE ARE OTHER EXAMPLES OF
PASSIVE ANTIBODY BASED
THERAPIES, HUMANER IMMUNE
GLOBULIN, MONOCLONAL ANTIBODIES,
SLOW TO BE MANUFACTURED, MAY NOT
KEEP PACE WITH VIRAL EVOLUTION,
AS WAS THE CASE CAN SARS-COV-2,
EMERGENCE OF VARIANTS ANDS
SUBVARIANTS RENDERING AGENTS
INEFFECTIVE.
CP MAY BE LESS VULNERABLE.
PRIOR TO THE COVID-19, ONE CATCH
IS THAT A LOT OF FAVORABLE
REPORTS ARE GLEANED AND
CONTROLLED OBSERVATIONAL
STUDIES, HOST OF LIMITATIONS.
WE'VE LEARNED A LOT DURING
COVID.
WE KNOW THAT CONVALESCENT PLASMA
SEEMS TO BE SAFETY, COMPARABLE
RISKS TO OTHER PLASMA PRODUCTS,
AND EFFICACY IS PREDICATED ON
HIGH-TITER ANTIBODIES.
PROPOSED APPROACH BROADLY WE
NEED RESEARCH TO GUIDE RATIONAL
PRACTICE, SO THIS IS JUST A LIST
OF SOME OF THE EXAMPLES OF
STUDIES THAT ARE WITHIN THAT
SCOPE.
SO DETERMINATION OF EFFICACY,
SELECTED HIGH RISK PATIENT
POPULATIONS.
INCLUDING IMMUNOCOMPROMISED,
OPTIMIZATION OF CONVALESCENT
PLASMA USE, PRODUCT
QUALIFICATION, DOSING,
INDICATION, NOT JUST FOR
SARS-COV-2 BUT OTHER PATHOGENS,
DEVELOPMENTS OF OPERATIONAL
STRATEGIES TO DEPLOY
CONVALESCENT PLASMA EARLY AND
RAPIDLY, RISK ASSESSMENT OF CP
IN LOW- AND MIDDLE-INCOME
COUNTRIES WHERE TRANSMISSIBLE
INFECTION MAY OUTWEIGH BENEFIT
OF CP AND COULD BE A ROLE FOR
PATHOGEN REDUCTION AND A HOST OF
BASIC SCIENCE QUESTIONS RELATING
TO UNDERSTANDING MECHANISM OF
ACTION AND DEVELOPMENT OF OTHER
PASSIVE ANTIBODY-BASED
THERAPIES.
NEXT SLIDE PLEASE.
SO IN TERMS OF BARRIERS,
FEASIBILITY SO THAT THERE'S -- I
SEE THIS AS A REAL OPPORTUNITY,
EVIDENCED BY THE COVID-19
PANDEMIC, MULTI-DISCIPLINARY AND
INTERDISCIPLINARY COLLABORATION
AND RESEARCH, REFLECTING ON
COVID-19, CHALLENGES RELATED TO
LACK OF HARMONIZATION AND THIS
WAS HIGHLIGHTED SPECIFICALLY BY
DR. SPITALNIK IN HIS KEYNOTE
CONTRIBUTING TO DUPLICATION OF
EFFORTS, STUDY OF SUBPOPULATION,
NEGLECT OF OTHERS.
AND EFFICACY OF CONVALESCENT
PLASMA, HYPER IMMUNE GLOBULIN,
MAY BE SPECIFIC TO A PATHOGENRY
INTRODUCES A RANGE OF CHALLENGES
SUCH AS THERE ARE MANY
PATHOGENS, EACH DERIVATIVE
TARGETING A GIVEN PATHOGEN, AND
THERE'S ALSO POTENTIAL FOR
EVOLUTION OF PATHOGEN, MUTATION,
VARIANTS.
LASTLY, RESEARCH OF DERIVATIVES
IS COMPLEX.
SO, MASSIVE NUMBERS OF CASES MAY
BE NEEDED TO JUSTIFY INVESTMENT
FOR NEW AGENT.
THERE COULD BE VALUE IN STORE,
WHAT WE LEARNED FROM ONE AGENT
COULD BE APPLIED TO REEMERGENCE
BUT RESOURCES ARE NEEDED TO
SUPPORT INCENTIVIZED COLLECTION.
I'LL HAND OVER TO DR. KATZ FOR
THE OTHER THREE.
>> THANKS, EVAN.
I HOPE OUR SEVERE THUNDERSTORMS
HERE DON'T DEGRADE THE AUDIO.
OUR WORK GROUP WAS FOUNDED ON
THE RECOGNITION THAT THERE ARE A
LOT OF POTENTIAL PATHOGENS
EMERGING, OR ARE THE POTENTIAL
TO DO SO, BOTH AS TTIs FOR
PATHOGENS IN THE GENERAL
POPULATION.
SO RISK ASSESSMENT ASKS WHAT
SYSTEMS WILL ALLOW COLLECTION
CONTEMPORANEOUS RISK FACTOR DATA
FROM BLOOD DONOR SURVEILLANCE
COHORTS AND HOW REPRESENTATIVE
OF THE GENERAL POPULATION THOSE
COHORTS MIGHT BE, WHAT
ADJUSTMENTS STATISTICALLY NEED
TO BE MADE TO ASSURE GENERALIZED
ABILITY.
NEXT.
EARLY IDENTIFICATION OF
POTENTIAL TTI MAY FACILITATE
ANALYSIS AND INTERVENTION, WE'RE
VERY REACTIVE AND TIME IS OF THE
ESSENCE IN THAT CIRCUMSTANCE.
THERE MAY BE AN OPPORTUNITY TO
OPTIMIZE AND PRIORITIZE OUR
PROCESSES IN COLLECTION
FACILITIES TO IDENTIFY THOSE
EIDs THAT MAY BE IMPORTANT AND
SUPPLEMENT AS WELL IN A PUBLIC
HEALTH MODE NON-DONOR
SURVEILLANCE EFFORTS.
NEXT.
THE PROPOSED APPROACH IS TO
DEVELOP AND ENHANCE ABILITY TO
EXTRACT USEFUL INFORMATION FROM
AVAILABLE OPERATIONAL DATA FROM
OUR VERY DIVERSE POPULATION OF
DONORS.
THESE INCLUDE STANDARD
DEMOGRAPHICS, DONOR HISTORY,
ELEMENTS INCLUDING WHAT WE
ALWAYS COLLECT AND ADDITION OF
SPECIALIZED NEW ELEMENTS,
APPROPRIATE ADJUSTMENTS ALLOWING
COMPARISON TO THE GENERAL
POPULATION, ESPECIALLY PROCESS
AND I.T. ENHANCEMENT COMPATIBLE
WITH RAPID TURNAROUND FOR NEWLY
RECOGNIZED POTENTIAL THREATS IN
GMP ENVIRONMENT.
FEASIBILITY AND BARRIERS INCLUDE
NEED TO MOVE VERY RAPIDLY IN OUR
HIGHLY REGULATED ENVIRONMENT,
AND THIS IS OPERATIONAL,
AFFECTED BY I.T. INFRASTRUCTURE,
QUITE DIVERSE IN THE U.S., AND
CONSIDERATIONS OF RESEARCH
ETHICS THAT MUST BE DEALT WITH.
WE NEED TO DEVELOP AND MAINTAIN
COLLABORATIVE RELATIONSHIPS WITH
OTHER SECTORS ESPECIALLY PUBLIC
HEALTH AND FIELD INVESTIGATORS
IN ORDER TO MAXIMIZE RELEVANCE
OF PROPOSED DATA COLLECTION AND
ITS TIMELINESS.
AND WE NEED AGAIN TO HAVE MODELS
TO MAXIMIZE GENERALIZABILITY TO
DONOR DATA TO THE POPULATION IN
GENERAL TO THE DEGREE WE'RE IN A
PUBLIC HEALTH FOCUS.
NEXT.
ENHANCED DONOR TESTING, OF
COURSE DONOR TESTING HAS BEEN
CENTRAL TO OUR RESPONSES TO
EMERGING INFECTIONS, THE
QUESTION IS HOW CAN WE ENHANCE
AND EXPAND THAT BOTH WITH
RESPECT TO PERFORMANCE
CHARACTERISTICS AND EFFICIENCY
TO BE ADAPTED BLOOD DONORS IN
EVENT OF EMERGING INFECTION AND
EVALUATE RISK TO BLOOD SUPPLY.
DETECTING-- EARLY DETECTION CAN
SUPPORT PUBLIC HEALTH EFFORTS.
THIS IS ENHANCED BY MULTIPLEX
PLATFORMS WHICH WILL NEED TO BE
EXPANDED PERHAPS MADE PRO-ACTIVE
TO EVALUATE AND IDENTIFY
POTENTIAL EID THREATS.
WE NEED FORMALIZED NATIONALIZE
AND GLOBAL NETWORKS TO USE
CONTEMPORARY TESTING PLATFORMS,
OPERATIONAL AND RESEARCH, FOR
SENSITIVE SURVEILLANCE THAN THE
CURRENT INFORMAL HORIZON
SCANNING USED NOW TO RECOGNIZE
POTENTIAL THREATS BEFORE THEY
CAUSED RECOGNIZED CLINICAL
ILLNESS VIA TRANSFUSION AND TO
RESPOND PROACTIVELY.
NEXT.
THERE ARE A LARGE NUMBER OF
VIRAL AND OTHER AGENTS THAT ARE
BEING RECOGNIZED AS HUMAN
PATHOGENS, AS YOU SAW ON OUR
FIRST SLIDE.
MANY HAVE THE POTENTIAL FOR
TRANSFUSION TRANSMISSION THAT
DEMAND IMPROVED SURVEILLANCE.
CURRENT SURVEILLANCE IS LARGELY
AN INFORMAL ACTIVITY,
ESSENTIALLY BASED ON VOLUNTEER
HORIZON SCANNING BY TRANSFUSION
MEDICINE EXPERTS AND/OR
RECOGNIZED INFECTION --
RECOGNITION THAT INFECTION WITH
A NOVEL PATHOGEN MAY HAVE BEEN
TEMPORALLY ASSOCIATED WITH
TRANSFUSION BY BEDSIDE
CLINICIANS NOT FOCUSED ON OUR
ISSUES.
FORMAL GLOBAL COMMUNICATION AND
RESEARCH NETWORKS FOCUSED ON
NOVEL TTIs ARE REALLY NOT
AVAILABLE AT THIS POINT.
SUCH NETWORKS WITH AC STOWS
FLEXIBLE STATE-OF-THE-ART IN
VITRO TESTING COULD SUPPORT
EARLY RECOGNITION, NOT JUST OF
POTENTIAL EIDs BUT IN OUR
SPECIFIC FOCUS THOSE THAT MIGHT
BE TRANSFUSION TRANSMITTED.
THE PROPOSED APPROACH TO
LEVERAGE NOVEL TESTING METHODS
AND PLATFORMS TO STUDY DONOR
POPULATIONS.
THE ENHANCED METHODS INCLUDE
HIGHLY MULTIPLEX NUCLEIC AND
SEROLOGIC PLATFORMS APPLIED TO
EXISTING DONOR REPOSITORY, RAPID
HIGH-THROUGHPUT METAGENOMIC AND
SEQUENCING PLATFORMS, TO USE AT
NEED, AND A FOCUS ON ZOONOTIC
AND VECTOR-BORNE THREATS.
WE NEED BROADLY REPRESENTATIVE
GLOBAL GEOGRAPHICALLY DIVERSE
NETWORKS EARLY WITH ACTIVITY
STUDIES IN BLOOD AND COMPONENTS
THAT ARE NOT GENERALLY PERFORMED
AT THIS POINT, APPROPRIATE
CONFIRMATORY ALGORITHMS,
CONCEIVABLY TIME LIMITED ROLLING
REPOSITORIES THAT CAN BE
INTERROGATED IN THE NEAR REAL
TIME IN RESPONSE TO THE
EMERGENCE OF NEW PATHOGENS.
NEXT.
NEXT SLIDE PLEASE.
THERE WE GO.
FEASIBILITY AND BARRIERS, WE
ALREADY HAVE INDUSTRY AND BLOOD
COMMUNITY COLLABORATION.
INTERNATIONAL COLLABORATIONS,
FOR EXAMPLE, REDS, ARE ALREADY
SUCCESSFUL IN APPLYING
STATE-OF-THE-ART TEST METHODS
BUT ARE SOME WHAT REACTIVE.
THIS HAS BEEN THE EXCEPTION.
THE NEED TO INTEGRATE OUR DONOR
CONCERNS WITH FRONT LINE
SURVEILLANCE IS CRITICAL AND
SUSTAINABILITY IS PROBLEMATIC IN
THE FACE OF OTHER U.S. AND
INTERNATIONAL FUNDING
PRIORITIES.
NEXT.
OUR NEXT PRIORITY WAS
SURVEILLANCE AND HORIZON
SCANNING FOR EMERGING INFECTIOUS
DISEASES, THE QUESTION IS HOW TO
OPTIMIZE USE OF BLOOD DONOR
POPULATIONS TO ADVANCE
EPIDEMIOLOGIC AND SURVEILLANCE
PATHOGENESIS RESEARCH OF
ESTABLISHED AND EMERGING
INFECTIONS INCLUDING THOSE THAT
MAY BE TRANSFUSION
TRANSMISSIBLE.
AABB AND OTHERS GENERATED SOME
TOOLS.
FOR EXAMPLE, AABB HAS LISTED
AGENTS THAT MAY BE TRANSFUSION
TRANSMITTED BASED ON VOLUNTARY
AND REALLY UNSYSTEMIC
ACTIVITIES.
SYSTEMATIC ACTIVITIES.
THE EUROPEAN UPFRONT RISK
ASSESSMENT TOOL CAN QUANTIFY
RISK, BASED ON A PRIORI
ASSUMPTION ABOUT EPIDEMIOLOGY
AND PATHOGENESIS, AND ON EXPERT
OPINION WHICH MIGHT BE
CHARACTERIZED AS WELL AS
SPECULATION.
NEXT.
SO, THE ISSUE IS PREDICTING
EMERGENCE OF A NOVEL PATHOGEN,
WHICH IS INHERENTLY CHALLENGING,
BLOOD DONOR SCREENING MAY BE
SUFFICIENTLY TIMELY TO PREVENT
EARLY SPREAD IN THE DONOR BASE
AND SUBSEQUENTLY TO TRANSFUSION
RECIPIENTS AND THERE'S NO
ESTABLISHED PRO-ACTIVE APPROACH
TO RECOGNIZING AND PROJECTING
THE IMPACT OF EMERGING
INFECTIOUS DISEASES ON BLOOD
SAFETY AND AVAILABILITY.
NEXT.
PROPOSED APPROACH IS DEVELOPMENT
OF PROGRAMS TO FOSTER EARLY
RECOGNITION BY OUR COMMUNITY OF
A NEW EMERGING INFECTION,
FOLLOWED BY SYSTEMATIC
ASSESSMENT OF ITS POTENTIAL FOR
TRANSFUSION TRANSMISSION, TO
ENABLE RAPID RESPONSE.
WHAT IS THE EVIDENCE OF
TRANSFUSION TRANSMISSIBILITY AND
RISK INCLUDING OUR STAFF, WHAT
IS DONOR INCIDENCE AND IMPACT,
WHAT ARE THE -- WHAT IS
APPROPRIATE DONOR SCREENING
OPTION INCLUDING RISK SCREENING,
IN VITRO TESTING, PATHOGEN
REDUCTION IMPLEMENTATION.
NEXT.
THE PROPOSED APPROACH IS TO LOOK
AT RECENT EXPERIENCE INCLUDING
WEST NILE, CHAGAS, ZIKA,
CHIKUNGUNYA, COVID, NOW
MONKEYPOX, AS THAT EXPERIENCE
DEVELOPS.
REFINEMENT OF EUFRAT-LIKE TOOLS,
WHERE ASSUMPTION ARE USED,
SUPPORT FOR RAPID RESPONSE
TESTING PLATFORMS, AND TO
INCENTIVIZE INCLUSION OF DONOR
SAMPLE IN INITIAL STUDIES OF
EMERGING PATHOGENS BY
ESTABLISHING FORMAL AND
SUSTAINABLE COLLABORATIONS OF
FIELD INVESTIGATORS WITH GLOBAL
BLOOD COMMUNITY.
INTERNATIONAL COLLABORATIONS,
FOR EXAMPLE REDS, ALREADY
SUCCESSFUL AS PREVIOUSLY STATED
IF STILL REACTIVE.
WHILE SUCH INDUSTRY AND BLOOD
COMMUNITY COLLABORATION IS
ALREADY COMMON, BROAD ROUTINE
FIELD RESEARCH BLOOD COMMUNITY
COOPERATION IS LESS SO,
ESPECIALLY IN THE AREAS MOST OF
INTEREST FOR EMERGENCE OF NOVEL
PATHOGENS.
SUSTAINABILITY AGAIN IS
PROBLEMATIC, IN THE FACE OF
OTHER FUNDING PRIORITIES.
NEXT.
THIS IS OUR PRIORITY SUMMARY
THAT EVAN AND I HAVE GONE
THROUGH FOR THE BREAKOUT
SESSION.
WHILE WE HAVE IDEAS ABOUT THE
RANKINGS, WE HAVE CHOSEN NOT TO
BIAS THE BREAKOUT SESSION BY
LISTING THEM NOW.
NEXT SLIDE.
I WANT TO ACKNOWLEDGE THE
EMERGING INFECTIONS WORK GROUP
LISTED HERE AND AGAIN TO THANK
THE ORGANIZERS FOR ASKING US TO
PARTICIPATE.
I BELIEVE THAT IS OUR LAST
SLIDE.
BACK TO YOU, BRIAN AND NAREG.
>> THANK YOU, DOCTORS BLOCH AND
KATZ.
AGAIN, TO ALL THE SPEAKERS FOR
THEIR PRESENTATIONS AS PART OF
THE MORNING'S GENERAL SESSION.
WE'VE COME TO OUR BREAK FOR
LUNCH.
>>HELLO, EVERYBODY.
I KNOW WE'RE COMING TOGETHER
AFTER HAVING BEEN IN THE
BREAKOUT ROOMS.
THANK YOU, EVERYBODY, FOR GOING
TO THOSE BREAKOUT ROOMS AND FOR
THE DIALOGUE THAT WE HAD OVER
THE LAST HOUR.
FOR THE OTHER TWO ROOMS IT WAS
INTERESTING, FOR DONOR AND
SUPPLY GROUP REALLY IMPORTANT
CONVERSATION BUILDING ON WHAT
WAS PRESENTED THIS MORNING BY
DR. BRYANT, AN OPPORTUNITY TO
REFLECT.
OF COURSE, THEY HAVE THE
DISTINCT DISBENEFIT OF NOW
HAVING TO REPORT BACK TO THE
LARGER GROUP WHAT WAS DISCUSSED
OVER THE LAST HOUR, SO I BELIEVE
THAT THEY WILL DO THAT, EACH
GROUP HAS UP TO 20 MINUTES TO
TALK ABOUT WHAT THEY HEARD IN
TERMS OF FEEDBACK OF THE DEFINED
RESEARCH PRIORITIES AND THE NEXT
STEPS.
I DID NOTICE ACTUALLY ON OUR
AGENDA IT SAYS CONCLUDING
REMARKS, OR CONCLUDING
STATEMENTS, THAT'S MORE THAN A
BIT UNFAIR.
IT'S REPORTING BACK AND IT'S THE
BEGINNING OF A CONVERSATION
RATHER THAN THE CONCLUSION OF A
CONVERSATION BUT NONETHELESS IT
IS AN OPPORTUNITY FOR YOU ALL TO
HEAR IN THE LARGER MEETING ON
THE STATE OF THE SCIENCE WHAT
WAS DISCUSSED.
WE'LL BELIEVE WITH DR. BRYANT,
ALSO REPORTING BACK TO US FROM
THE FIRST WORKING GROUP.
THANK YOU.
>> THANKS, BRIAN.
BRIAN HELPED COORDINATE CALLING
ON PEOPLE AND KEEPING TRACK.
WE DIDN'T GET THROUGH ALL THE
COMMENTS IN THE CHAT BOX BUT GOT
THROUGH SOME VERY IMPORTANT
ONES.
I'D LIKE TO SAY THANK YOU TO THE
THOUGHTFUL CONTRIBUTIONS FROM
THE BREAKOUT PARTICIPANTS.
GREAT GROUP OF PEOPLE, ALL OF US
IN ONE ROOM EVEN THOUGH IT WAS
VIRTUAL.
GREAT FEEDBACK.
THIS IS STUFF WE'LL CONSIDER AS
WE LOOK AT THE PRIORITIES THAT
WE'VE PUT TOGETHER, THE DRAFT
PRIORITIES.
SO, JUST TO SUMMARIZE A LITTLE
BIT, I THINK ONE OF THE FIRST
THINGS THAT CAME UP WAS BUILDING
OF RESEARCH PARTNERSHIPS, AND
CHALLENGE THAT THERE IS BECAUSE
THIS ISN'T JUST THE REGULAR
TRANSFUSION MEDICINE ROLE.
THIS IS LOOKING AT FOLKS THAT
ARE DOING THE PSYCHOLOGICAL
WORK, ANALYSIS, ANTHROPOLOGISTS,
MATHEMATICIANS, HOW DO YOU BRING
THESE PEOPLE IN AND ATTRACT THEM
TO WANT TO DO TRANSFUSION
MEDICINE WORK.
IT'S A BLENDING OF ACADEMIC AND
BLOOD CENTERS.
AND THIS IS SOMETHING THAT WE
HAVEN'T SEEN BEING DONE
STRONGLY.
SURE, THERE'S BEEN PEOPLE IN THE
GROUP SUCCESSFUL DOING IT, BUT
THIS IS SOMETHING WE'LL HAVE TO
MAKE SURE THAT WE OPEN THE DOORS
IN BOTH DIRECTIONS TO WORK
TOGETHER.
ALSO, COMMUNITY-BASED RESEARCH
WAS SOMETHING BROUGHT UP THAT
CONTINUES TO BE VERY IMPORTANT
THAT IS INTEGRAL IN WHAT WE'LL
BE DOING.
RESEARCHERS WITH TRUST ALREADY
DEVELOPED, MY NOTES, SOMETIMES
THEY DON'T MAKE ALL THE SENSE IN
THE WORLD.
THOSE RESEARCHERS THAT HAVE DONE
THIS HAVE DEVELOPED TRUST WITHIN
THE BLOOD BANKING COMMUNITY AND
VICE VERSA AND WILL BE GREAT
LEADERS AS WE MOVE FORWARD.
HOW DO WE GET COLLEGES AND
UNIVERSITIES TO LOOK AT THE FACT
THAT THEY COULD PARTNER WITH US
TO DO THESE THINGS.
LET'S SEE.
ONE OF THE OTHER CONCERNS IS
THAT WHEN WE GO OUT FOR FUNDING,
THAT HOW DO WE GET -- LET ME SEE
MY OTHER NOTES, HOW DO WE GET
PEOPLE ON THE COMMITTEES TO
UNDERSTAND THE IMPORTANCE OF
THESE OTHER FOLKS THAT MAYBE
AREN'T YOUR TYPICALLY PEOPLE
PUTTING THROUGH FOR TRANSFUSION
MEDICINE RESEARCH MONEY.
THAT THE PSYCHOLOGISTS AND THE
SOCIOLOGISTS, ALL THAT.
THIS IS IMPORTANT, POSSIBLY
PEOPLE THAT ARE FROM THE
ACADEMIC SHOULD BE PART OF THESE
GROUPS THAT ARE GIVING OUT THE
FUNDING.
THAT WILL BE IMPORTANT.
NEXT BIG TOPIC WAS A LOT OF
DISCUSSION ABOUT BLOOD DONATION
AND PLASMA DONATION, COMPARING
MOTIVATION AND BEHAVIORS AND
CONSTRAINTS OF BOTH GROUPS.
I DON'T KNOW IF WE'RE MORE ALIKE
OR MORE DIFFERENT.
WE FREQUENTLY SEE OURSELVES AS
COMPETITORS, MAYBE THAT'S NOT
EXACTLY RIGHT BUT WE DON'T KNOW
FOR SURE.
MANY DONORS IN THE PLASMA CENTER
RELY ON THE MONEY THEY ARE
GETTING TO SUPPORT THEMSELVES,
TO FEED THEMSELVES.
IT'S A HEALTH EQUITY ISSUE.
HOW DOES THIS PLAY INTO GETTING,
YOU KNOW -- PLAY INTO BLOOD
DONATION?
IS THERE A ROLE FOR PAYING
DONORS FOR THE SAME REASON?
ARE THEY DIFFERENT?
ARE THEY SIMILAR?
THEY MAY BE MOTIVATED MORE THAN
WE THINK.
ANOTHER ISSUE THAT CAME UP, I'M
GOING TO JUMP OVER, SOME
BARRIERS THAT WE SAW WERE
BARRIERS OF LOCATION.
SOMETIMES THE LOCATIONS OF OUR
BLOOD CENTERS AREN'T EXACTLY IN
THE LOCATIONS THAT YOU WANT THEM
TO BE IF YOU'RE TRYING TO
RECRUIT UNDERREPRESENTED
MINORITIES.
AND SO, THERE'S AN INEQUITY IN
BURDEN THERE FOR DONOR TO GET
DOWN TO A BLOOD CENTER.
ONE SECOND, BARBARA.
>> ONE SECOND, BARBARA.
WE LOST YOU.
CAN YOU HEAR US?
>> BARBARA, WE CAN'T HEAR YOU
ANYMORE.
>> UNFORTUNATELY BARBARA, I
DON'T KNOW, WE CANNOT HEAR YOU.
>> WE CANNOT HEAR YOU.
>> CAN YOU HEAR ME NOW?
>> YES.
>> HOW MUCH OF THAT DID Y'ALL
MISS?
THE WHOLE THING?
>> THE LAST MINUTE OR TWO.
>> OKAY, GOOD.
I STARTED THIS THING, I'VE BEEN
ON THE PHONE.
THE NIH PHONE MUST HAVE
DISCONNECTED AFTER SO MANY
HOURS.
WHERE DID I LAST LEAVE OFF?
DID I GET TO BLOOD DONATION OF
PLASMA?
MERLYN, DID I GET THROUGH MOST
OF THAT?
I CAN'T HEAR YOU.
>> YES, YOU DID, BARBARA.
>> I'D LOVE TO HEAR IT AGAIN.
>> SO, WE'RE COMPARING
MOTIVATION BETWEEN BLOOD DONORS
AND PLASMA DONORS AND
CONSTRAINTS, A LOT OF TIMES
PLASMA DONORS NEED THE MONEY TO
FEED THEIR HOUSEHOLDS, IT'S A
HEALTH EQUITY TYPE ISSUE.
BUT OTHERWISE, ARE THEY
DIFFERENT OR SAME?
WHAT ARE THE MOTIVATIONS?
WE DON'T KNOW BECAUSE WE HAVEN'T
ASKED THE QUESTION.
AND THEN FOR THE METHODS GROUP,
SEVERAL TIMES FOCUS GROUPS CAME
UP.
WE NEED PROBABLY MORE FOCUS
GROUPS, AS WE LOOK AT DONORS
ASKING THEM WHY DO YOU DONATE AS
OPPOSED TO NON-DONORS WHY HAVE
YOU NEVER DONATE OR STOP?
THERE NEEDS TO BE MORE TALKING
AND ENGAGING. ONLINE RESEARCH,
FOLKS COMMENTED ABOUT THAT.
I'M NOT SURE, TOTALLY UNDERSTAND
ALL THE ASPECTS OF THIS ANALYSIS
THAT THEY WOULD BE ABLE TO DO
WITH THAT.
ONE OF THE CHALLENGES ALSO
DEALT -- BARRIERS DEALT WITH
LOCATIONS.
WE HAVE OUR BRICK AND MORTAR
CENTERS NOT IN AREAS WHERE
THERE'S UNDERREPRESENTED
MINORITIES, AND THIS IS AN
INEQUITABLE BURDEN FOR THOSE
DONORS.
ALSO WITH MOBILES, IT'S HARD TO
PREDICT.
YOU'RE NOT ALWAYS PREDICTING
WHERE THEY ARE GOING TO BE.
THAT'S SOMETHING THAT NEEDS TO
BE LOOKED AT.
WE TALKED QUITE A BIT ABOUT
STUDENTS.
HIGH SCHOOL STUDENTS THAT WE
HOPED THAT BEING BLOOD DONORS
THROUGH THE HIGH SCHOOL YEARS
THAT WOULD CONTINUE TO BE DONORS
DURING COLLEGE AND BEYOND BUT
LOOKS THAT'S NOT COMING TO BE
TRUE.
WHY DO THESE DONORS NO LONGER
THINK THEY DON'T HAVE THE DONOR
IDENTITY?
IT WAS THERE IN HIGH SCHOOL, NOT
SO MUCH IN COLLEGE AND BEYOND.
WHAT CAN WE DO, HOW CAN WE
CAPTURE THOSE AND RETAIN THOSE
DONORS?
MORE DISCUSSION ABOUT IMMIGRANT
POPULATIONS, TAILORING OR
MESSAGE TO THOSE GROUPS OF
PEOPLE.
THAT'S VERY IMPORTANT.
AND LET'S SEE HERE.
RESEARCH FUNDING.
OH, I THINK I MENTIONED THAT
EARLIER, RESEARCH FUNDING WHEN
WE START GETTING TOGETHER PEOPLE
TO REVIEW, THERE WILL BE PEOPLE
THAT UNDERSTAND THE NEED FOR
COLLABORATIONS WITH PEOPLE THAT
ARE OUTSIDE THE TRANSFUSION
MEDICINE WORLD TO HELP US TAKE A
LOOK AT WHAT WE'VE GOT GOING ON.
ALL IN ALL, A BUNCH OF
THOUGHTFUL CONTRIBUTIONS FROM
EVERYBODY THERE.
THE GOOD THING, I DON'T THINK WE
MISSED ANYTHING IN OUR LIST OF
PRIORITIES.
THERE WAS A DISCUSSION, A POINT
MADE MAYBE PRIORITY 4 WHICH WAS
MESSAGING AND CHANNELS COULD BE
COMBINED WITH INNOVATIVE AND
INCLUSIVE USES AND INFORMATION
THAT WAS PRIORITY 5 SO WE'LL
TAKE A LOOK AT THAT AND CONSIDER
IT.
SO, MERLYN, DID I MISS ANYTHING
ELSE?
>> NO, I THINK THAT'S IT,
BARBARA.
>> OKAY.
ALL RIGHT.
WELL, THANK YOU VERY MUCH.
THANKS, BRIAN.
>> THANK YOU VERY MUCH, BARBARA
AND MERLYN.
THERE WAS QUITE AN EXTENSIVE
CHAT DISCUSSION TOO ASSOCIATED
THAT WE HAVE CAPTURED, THAT THE
WORKING GROUP WILL BE ABLE TO
BUILD OFF OF.
SO I WANT TO ACKNOWLEDGE
EVERYBODY WHO DID PROVIDE THOSE
COMMENTS.
THEY WILL NOT BE IGNORED IN ANY
WAY.
ALL RIGHT.
NEXT IS FOR US TO MOVE TO THE
NEXT WORKING GROUP, OPTIMIZING
TRANSFUSION OUTCOMES.
>> HELLO.
I'M GOING TO BE YOUR SUMMARIZER.
AND THEN DARRELL IS GOING TO
JOIN IN, IF I MISS ANYTHING OR
AT LEAST DON'T CAPTURE
SOMETHING.
THERE WAS GREAT DISCUSSION IN
THIS GROUP, LOTS OF TOPICS TO
DISCUSS, BUT I JUST WANTED TO
GIVE EVERYBODY KIND OF A
REMINDER OF WHAT OUR TOPICS
WERE, JUST TO RUN IT DOWN AGAIN.
SO, THERE WERE TEN.
FIRST WAS RED CELL ACUTE ANEMIA
MEASURES, SECOND WAS
PROPHYLACTIC TRANSFUSION,
NON-HEMOSTATIC FUNCTION, THE
IMMUNE SYSTEM.
RED CELL CHRONIC TRANSFUSION,
BLEEDING MANAGEMENT.
AND THEN THE OTHER FIVE WERE RED
CELL NISHOTS, FIBROGEN,
GUIDELINES, IMPLEMENT SCIENCE
AND COMPARING PRODUCTS.
WE HAD PEOPLE COMMENT WITH
SYNTHESIS OF WHAT WAS DISCUSSED.
ACTUALLY, IT WAS VERY NICE
BECAUSE THERE WERE THEMATIC
THINGS FOR EVERYTHING THAT CAME
OUT THAT WERE THE SAME KINDS OF
THEMES THAT CAME OUT WHEN WE
WERE HAVING OUR COMMITTEE
MEETINGS OVER THE LAST SEVERAL
MONTHS AND OUR SUBGROUP
MEETINGS.
AND I THINK THAT IF WE THINK
ABOUT THIS GOING ACROSS THE
DIFFERENT SUBGROUPS, REALLY THE
PLATELET COUNT AND HEMOGLOBIN
SEEM TO HAVE LOST THEIR MEANING
AND WE'VE LOST OUR WAY IN THE
SENSE OF USING THOSE AS A
TRANSFUSION TRIGGER.
AND SO, IN SOME WAYS WE'VE
OUTGROWN THEM.
WE'VE STUDIED THEM AND THEY HAVE
TRAPPED US IN A WAY THAT WE
REALLY CAN'T -- IT'S LIMITED US
TO LOOK BETTER AT PATIENT
OUTCOMES.
SO THE THOUGHT PROCESS WAS THAT
WE NEEDED TO HAVE A FUTURE WHERE
WE DEVELOP OTHER THINGS THAT ARE
GOING TO HELP US WITH
INDICATIONS OR OUTCOMES OF
TRANSFUSION.
THEY ARE NO LONGER IDEAL.
THAT WAS A HUGE SUMMARY
STATEMENT.
I WOULD SAY THAT WHAT WE DO NEXT
IN BOTH THE BLEEDING SPACE AND
IN THE OXYGEN CARRYING CAPACITY
OR TISSUE OXYGENATION SPACE HAS
TO DO WITH DEVELOPING BETTER
MEASURES EITHER USING HEMOGLOBIN
IN CONJUNCTION WITH NIRS OR
OTHERS MEASURES IN THE ICU,
DIFFERENT MONITORING TECHNIQUES,
TO COME UP WITH A BETTER WAY
FUNCTIONALLY TO ASSESS OUTCOMES
AND SO IN THE OXYGENATION,
TISSUE OXYGENATION SPACE,
INCORPORATING ALSO WHAT PATIENTS
ARE EXPERIENCING INTO THAT
OUTCOME.
SO, VERY FUNCTIONAL.
ALL THE WAY TO ASKING THE
PATIENT, NOT JUST WHAT WE CAN
MEASURE WITH NEW MEASURING
TECHNIQUES.
WITH PLATELETS AND RED CELLS,
GLOBAL WAYS TO MEASURE, TOO
LIMITED WITH PTT AND PT AND INR,
WE'VE BEEN TALKING ABOUT THIS
FOR A LONG TIME, PLASMA
PRODUCTS, SO REALLY
CONCENTRATING AND MOVING TO THE
NEXT DIRECTION OF DEVELOPING
WAYS TO STUDY THIS IN A MORE
PRECISION-BASED MEDICINE WAY.
HOW DID THIS ALL COME ABOUT?
ALL THE SCIENCE HAS LED US TO
UNDERSTAND THAT WHAT'S IN THE
PLATELET BAG AND WHAT'S IN THE
RED CELL BAG IS MUCH MORE
SOPHISTICATED THAN WE EVER
THOUGHT.
AND SO, PLATELETS AND RED CELLS
SEEM TO HAVE OTHER FUNCTIONS
WHICH HAVE BEEN DEFINED IN A LOT
OF DIFFERENT WAYS, AND ISN'T
JUST FOR PLATELETS FOR
HEMOSTASIS AND RED CELLS FOR
OXYGEN-CARRYING CAPACITY, THAT
THERE MAY BE IMMUNOLOGIC
FUNCTIONS, ANGIOGENIC FUNCTIONS,
FLOW CAPACITY, AND WE NEED TO
STOP LOOKING ONE DIMENSIONALLY
AND LOOK MORE BROADLY.
THE ENDOTHELIUM AS AN ORGAN
NEEDS TO BE STUDIED IN
RELATIONSHIP TO THIS, LEADING TO
COMMENTS ABOUT EXTRACORPOREAL
CIRCUITS, HOW DO WE UNDERSTAND
THAT IN EVERYTHING IN THAT
MILIEU AND WE NEED TO GET MORE
SOPHISTICATED IN THAT AREA.
THERE WERE ALSO IDEAS THROUGH
THE LIFESPAN RECIPIENTS REACTING
IN DIFFERENTIAL WAY TO RED CELL
TRANSFUSION, PLATELETS, AND
PLASMA AND THE VOLUME, DOSE,
RATE AROUND WHAT POTENCY OR
PRODUCTS DO FOR DIFFERENT
POPULATIONS IS IMPORTANT.
DIVERSITY, EQUITY, AND INCLUSION
NEEDS TO BE CONSIDERED WHEN IT
COMES TO RECIPIENTS, WHO ARE THE
PATIENTS THAT ARE BEING
TRANSFUSED ON A REGULAR BASIS,
AND PEOPLE WITH HEMOGLOBIN BE
O N -- HEMOGLOBINOPATHIES,
DIFFERENCES BETWEEN MEN AND
WOMEN, AND STUDIES POINTING
TOWARD THAT DIRECTION, PROBABLY
DIFFERENTIAL RESPONSES FOR
DIFFERENT PRODUCTS AS WELL.
THAT WAS DISCUSSED, AND BROUGHT
OUT TO BE IMPORTANT.
FINALLY WHAT IS THE EFFICACY OF
TRANSFUSION VERSUS THE SAFETY
PROFILE OF TRANSFUSIONS?
WHEN ARE WE TOO MUCH ONE SIDE OR
THE OTHER?
HOW ARE WE GOING TO INCORPORATE
THAT INTO TRANSFUSION STUDIES
THAT HAVE TO DO WITH WOMEN, HAVE
TO DO WITH TRAUMA VICTIMS, ARE
WE BEING TOO CONSERVATIVE WHERE
WE DON'T GIVE CERTAIN THINGS
BECAUSE WE'RE WORRIED, BUT SOME
OF THAT ALL STEMS FROM THE FACT
WE DON'T UNDERSTAND WHAT IS
GOING TO BE THE ACTUAL BENEFIT.
AND I THINK COMING TO A PLACE OF
STUDYING THOSE THINGS TOGETHER
IS GOING TO BE IMPORTANT TO THE
FUTURE OF HOW WE ADDRESS MANY OF
THE AREAS THAT WERE IDENTIFIED
BY THIS SUBGROUP OF THE STATE OF
THE SCIENCE.
WITH THAT I'LL LET YOU, DARRELL,
FILL IN OTHER PARTS YOU THINK I
MISSED.
>> YEAH, I THINK YOU COVERED IT
WELL.
I'LL EMPHASIZE ALMOST EACH
GROUP, WHETHER IT WAS PLATELETS
OR PLASMA OR RED CELLS,
DEFINITELY WANTED NHLBI TO
CONSIDER THE DONOR
CHARACTERISTICS THAT COULD
RESULT IN VARIABLE EFFICACY OF
THE PRODUCT ITSELF.
THOSE DONOR CHARACTERISTICS MAY
BE DONOR SEX, IT MAY BE DONOR
SMOKING STATUS, IT MAY BE DONOR
HEMOGLOBIN OR PLATELET CONTENT.
WE'RE LEARNING ABOUT THESE DONOR
AND COMPONENT CHARACTERISTICS
THAT MIGHT BE RELATED TO
OUTCOME.
SOME MAY BE NOT NECESSARILY
DONOR BUT MANUFACTURING STEPS,
OR TECHNIQUES SUCH AS COLD STORE
PLATELETS VERSUS ROOM
TEMPERATURE PLATELETS.
WE TALKED ABOUT P.I. RED CELLS
VERSUS NON-P.I. RED CELLS.
AND SO P.I. PLATELETS VERSUS
NON-P.I. PLATELETS.
SO, ALONG THE ENTIRE CONTINUUM
OF DONOR CHARACTERISTICS,
COMPONENT MANUFACTURING
CHARACTERISTICS TO WHAT IS THE
APPROPRIATE INDICATION WHICH WE
NOW KNOW IS -- WE'RE BEYOND JUST
HEMOGLOBIN OR PLATELET COUNT,
AND THEN WHAT ARE THE OUTCOMES
TO MEASURE.
SO, IT REALLY WAS AMAZING THE
CONSISTENCY OF THE COMMENTS
ACROSS THE DIFFERENT TYPES OF
BLOOD PRODUCTS.
AND ALTHOUGH IT WAS NOT IN OUR
TOP FIVE THAT WE PRESENTED, WE
SPENT QUITE A BIT OF TIME ON
NON-INFECTIOUS HAZARDS OF
TRANSFUSIONS AS CASSANDRA
MENTIONED SO ULTIMATELY WE CAN
UNDERSTAND RISK/BENEFIT PROFILE
OF AN INTERVENTION.
>> WE'RE GOING TO INCLUDE THAT
JUST TO MAKE SURE, DARRELL,
EVERYBODY HEARS THIS LOUD AND
CLEAR, JUST BECAUSE WE ALL CAME
UP WITH THOSE TOP FIVE AND WE
REALLY TRIED HARD TO BE ABLE TO
HAVE THOSE TO PRESENT, WE'RE
GOING TO BE DEVELOPING A
MANUSCRIPT THAT WILL COME FROM,
YOU KNOW, THE STATE OF THE
SCIENCE AND MAYBE EVEN EACH ONE
OF THESE GROUPS.
AND EVENTUALLY, WE'LL BE ABLE TO
INCORPORATE WHAT OTHER PEOPLE
HAVE SAID AND HOW WE PUT THIS
TOGETHER, BECAUSE IT'S REALLY
IMPORTANT TO BE ABLE TO
INTEGRATE ALL OF EVERYBODY'S
COMMENTS INTO THIS BECAUSE THEY
ALL ARE MEANINGFUL AND TO SOME
EXTENT ALL OF US ARE EXPERTS IN
THIS FIELD.
SO WE WANT ALL OF OUR THOUGHTS
TO BE INCORPORATED.
>> VERY MUCH THE PERSONALIZED
MEDICINE APPROACH TO GENERALIZED
CLINICAL CARE CAME THROUGH LOUD
AND CLEAR FROM THIS GROUP, WHICH
WAS EQUALLY REPRESENTED BY
TRANSFUSION MEDICINE PHYSICIANS
AND CLINICIANS, INTENTIONALLY.
WE REALIZE THAT TO BE
PERSONALIZED IN OUR APPROACH TO
TRANSFUSION, WE HAVE TO EVOLVE
BEYOND AN HEMOGLOBIN, PLATELET
COUNT, PTINR TO DO THAT AND
HELPING TO IMPROVE PATIENT
OUTCOMES.
THAT'S WHAT I WOULD SAY IS
REALLY THE OVERARCHING TEAM THAT
CAME OUT FROM THIS DISCUSSION.
>> I AGREE.
ARE WE SUPPOSED TO TAKE
QUESTIONS?
I SEE A HAND UP.
I DON'T KNOW HOW THIS IS
SUPPOSED TO GO.
>> WE DO HAVE TIME, ACCORDING TO
THE SCHEDULE.
>> YEAH, WE DO HAVE TIME.
SO WITH THAT IN MIND ACTUALLY I
THINK IT WOULD BE JUST FINE.
>> I'M COOL WITH THAT.
>> JULIE, DO YOU WANT TO ASK?
>> THANK YOU VERY MUCH.
IT WAS GREAT PARTICIPATING IN
THIS GROUP DISCUSSION.
I'M COMING FROM PERSPECTIVE OF
(INAUDIBLE) AND SICKLE CELL
DISEASE AND THE THIRD ASPECT IS
WORKING FROM AFRICA.
I THINK TOWARDS THE END OF THE
DISCUSSION IN OUR WORKING GROUP
THERE WAS A COMMENT ABOUT THE
ISSUE ABOUT DIVERSITY AND
EQUITY.
NOT JUST FROM PERSPECTIVE OF
DONORS BUT PERSPECTIVE OF
SCIENTISTS.
ONE OF THE THINGS THAT I WANTED
TO MAKE A COMMENT WAS
SPECIFICALLY FOR SICKLE CELL
DISEASE, WE HAVE A SITUATION
WHERE WE HAVE PATIENTS WITH A
HEMOGLOBIN LESS THAN 5 GRAMS PER
DECILITER, 5% COME TO THE
CLINIC, 20% OF THE HOSPITALIZED
PATIENTS HAVE HEMOGLOBIN LESS
THAN 5.
IN THIS ISSUE THE ISSUE IS THEY
NEED BLOOD AND THERE'S
INADEQUATE BLOOD AND THERE ARE
CONSEQUENCE ABOUT CONSEQUENCES
OF SEVERE ANEMIA ON SICKLE CELL
DISEASE.
AND WHEN YOU HAVE TOO MUCH
BLOOD, WE'VE HAVE HAD INSTANCES
WITH INDIVIDUALS OR PARTICULARLY
CHILDREN WHO HAVE BEEN
TRANSFUSED AND HAD UNFORTUNATELY
POSTERIOR REVERSIBLE
(INDISCERNIBLE) SYNDROME,
REVERSIBLE, THEY WERE ABLE TO
RECOVER FROM THE NEUROLOGICAL
COMPLICATIONS SO THESE ARE TWO
INSTANCES, I THINK THIS WAS
DISCUSSED, TOO MUCH AND I THINK
SOMEBODY ELSE TALKED ABOUT THE
RATE WHERE YOU MAY BE
TRANSFUSING TOO FAST.
THE THIRD -- AND THESE ARE AREAS
FROM A CLINICAL PERSPECTIVE THAT
I THINK ARE IMPORTANT RESEARCH
QUESTIONS THAT NEED TO BE
ANSWERED.
AGAIN, SOMETHING THAT WAS
RAISED, THAT THERE'S A GAP IN
CLINICAL SCIENCE, REALLY ABOUT
THERAPEUTIC BLOOD TRANSFUSION,
WHETHER IT'S IN ACUTE OR CHRONIC
FACE.
I'M BIAS BECAUSE MY PERSPECTIVE
IS LOOKING FROM PERSPECTIVE OF
SICKLE CELL AND OF AFRICA.
OVER TO YOU.
THANK YOU.
>> JULIE, THAT WAS AWESOME.
WHAT A GREAT SUMMARY OF AN
ASPECT OF WHAT WE TALKED ABOUT
WHICH BROUGHT IN DIFFERENT
THINGS.
DEFINITELY DIVERSITY OF THE
PHYSICIANS AND INVESTIGATORS
REPRESENTED HERE, THAT WAS
BROUGHT UP.
THAT IS A VERY IMPORTANT ASPECT
OF THINGS.
SO I'M REALLY GLAD YOU'RE
SPEAKING UP FOR WHERE YOU'RE
PARTICIPATING FROM BECAUSE IT
DEFINITELY PRESENTS SIMILAR
ISSUES BUT SOME OTHER, YOU KNOW,
BIG DIFFERENCES IN AVAILABILITY
OF RESOURCES AND THEN HOW DO YOU
MANAGE THAT AND MANAGE THOSE
POTENTIAL CONSEQUENCES.
WE DID TALK A LOT ABOUT TACO,
THIS IS NOT TACO IN CHILDREN BUT
TACO ALL OVER BEING, YOU KNOW,
ONE OF THE NUMBER ONE
TRANSFUSION REACTION MORBIDITY
AND MORTALITY THINGS IN THE U.S.
AS WELL.
I THINK THAT WE SORT OF WRITE IT
OFF.
WE THINK IT'S OVERLOAD.
BUT THERE ARE MANY CIRCUMSTANCES
OF THE PATIENT THAT WE NEED TO
TAKE INTO ACCOUNT LIKE A VERY
LOW HEMOGLOBIN AND HOW MUCH WE
TRANSFUSE, HOW FAST, HOW MUCH
ARE WE DOING IT WITH AND NOW
THAT WE UNDERSTAND THERE'S
DIFFERENCES IN RED CELLS HOW
LONG HAS THAT BEEN BLOOD STORED,
ARE THERE DIFFERENCES IN THE
BIOLOGIC CHARACTERISTICS FROM
DONOR TO DONOR, IS THAT IN
EFFECT?
THAT BRINGS OUT AN ENTIRE OTHER
ASPECT OF RED CELL TRANSFUSION
WE NEED TO CONCENTRATE ON.
I'M SUPER HAPPY YOU BROUGHT THAT
UP.
AND LIKE I SAID, LIKE DARRELL
SAID, THERE WERE A LOT OF
COMMENTS THAT CAME INTO THE
CHAT, AND THIS IS AN ONGOING
DISCUSSION AND WE WANT TO
INCORPORATE WHAT OTHER PEOPLE
THINK ARE IMPORTANT QUESTIONS TO
BE ANSWERED.
AND SO I JUST WANT TO SAY THANK
YOU, JULIE, FOR SAYING ALL OF
THAT.
QUENTIN?
>> A VERY GENERAL QUESTION
FOLLOWING ON JULIE'S POINT,
WORKING IN AFRICA, WHERE I AM
FROM MYSELF.
I KNOW THE REDS PROGRAM ENTER
NATIONAL BUT WHAT IS THE SCOPE
OF THE INITIATIVE TO EXPAND MORE
BROADLY AND HAVE INITIATIVES
WITH DOMAINS LIKE AFRICA AND
OTHER PARTS OF THE WORLD?
THERE'S AN ENORMOUS AMOUNT OF
COLLABORATIVE OPPORTUNITY AND
THINGS WE CAN LEARN BY THESE
CROSS-COLLABORATIVE
OPPORTUNITIES.
SOMEONE COULD ELUCIDATE, THAT
COULD UNEARTH THE BEGINNING,
U.S.-CENTRIC, BUT I'M CURIOUS IF
ANYONE CAN ANSWER THAT.
>> I DON'T KNOW IF NHLBI WANTS
TO TAKE THAT OR OUR CALL WAS TO
PUT SCIENCE -- WHAT ARE
SCIENTIFIC QUESTIONS, THAT'S WHY
THIS IS VERY IMPORTANT, WHAT
EVERYBODY'S BRINGING BUT THE
MECHANISM AND HOW IT GETS DONE,
I DON'T BELIEVE HAS TO BE
LIMITED TO THE UNITED STATES BUT
I'M GOING TO LET THE NHLBI OR
BRIAN AND NARIG ANSWER.
>> THIS IS SIMONE.
YES, OF COURSE, INTERNATIONAL
COLLABORATIONS, AS WE ALL KNOW,
ARE EXTREMELY IMPORTANT.
SO, WE CERTAINLY, YOU KNOW, AS
WE GO FORWARD THE GOAL OF THIS
PARTICULAR EFFORT WAS FIRST OF
ALL TO INVITE EVERYONE TO
PARTICIPATE AND COME UP WITH
SCIENTIFIC RESEARCH PRIORITIES.
SO, YOU KNOW, THAT'S HOPEFULLY
WHAT WE'RE DOING.
BUT THERE IS NO DOUBT THAT OF
COURSE INTERNATIONAL
COLLABORATIONS ARE REALLY
IMPORTANT.
>> THANK YOU, SIMONE.
DOES ANYBODY ELSE HAVE
QUESTIONS?
ABOUT WHAT WE PUT UP?
OR OTHER QUESTIONS THAT OTHER
PEOPLE WANT TO ANSWER?
>> I'M GOING TO TAKE SOME
PREROGATIVE.
I WOULD LIKE TO MAKE SURE THE
EMERGING INFECTIOUS GROUP HAS A
CHANCE TO CONVEY, AND IF THERE
ARE FURTHER THOUGHTS, PLEASE
ENTER THEM IN THE CHAT BOX.
YOU DON'T NECESSARILY HAVE TO GO
OFF MUTE TO MAKE SURE YOU'RE
CONVEYING ANY IMPORTANT POINT.
PLEASE DO DO THAT.
IT'S VERY IMPORTANT.
THAT'S ANOTHER SOURCE TO PROVIDE
INPUT.
FOR NOW I WANT TO GIVE EMERGING
INFECTIONS, EMERGING AGENTS
GROUP A CHANCE TO SUMMARIZE
THEIR BREAKOUT SESSION.
>> THANK YOU, EVERYBODY.
THANKS.
>> SO THAT'S US.
CAN I SHARE SLIDES?
ONE SECOND.
NO PRESSURE WHATSOEVER.
OKAY.
SO, THANKS VERY MUCH.
I'M GOING TO PRESENT THE
FINDINGS FROM OUR BREAKOUT
SESSIONS, EMERGING INFECTIONS.
SO THE FIRST THING WE ACTUALLY
SUCCESSFULLY MANAGED TO RANK OR
RERANK THE PRIORITIES.
THE WAY THIS IS COMING OUT WE'VE
BEEN LEFT WITH FIVE RATHER THAN
FIVE PLUS ONE AS WHAT WE HAD
BEFORE.
PRIORITY 1 SURVEILLANCE HORIZON
SCANNING AND RISK ASSESSMENTS
FOR EID.
TWO IS LEVERAGING DONOR
POPULATIONS.
THREE IS PATHOGEN REDUCTION OF
BLOOD PRODUCTS.
FOUR ENHANCED DONOR TESTING.
FIVE, APPLICATION OF BLOOD
DERIVATIVES TO TREAT INFECTIOUS
DISEASES, ALL ORIGINAL LISTS
WERE CONSOLIDATED AND MADE IT
IN.
PRIORITIES 1 AND 2 WERE CLEARLY
IDENTIFIED AS FRONTRUNNERS WITH
RESPECT TO IMPORTANCE.
ALL THE PRIORITIES WERE DEEMED
TO BE IMPORTANT, INDEPENDENT OF
SOURCE OF FUNDING.
THERE WAS SOME DEBATE WOULD THIS
BE SOMETHING WHICH NHLBI WAS
WILLING TO FUND.
THAT WAS STILL DEEMED TO BE
IMPORTANT.
AS I MENTIONED SURVEILLANCE,
HORIZON SCANNING, RISK
ASSESSMENT WERE ULTIMATELY
COMBINED WHICH MADE SENSE.
WITH RESPECT TO PRIORITY 1, WE
ALREADY UNDERTAKE SURVEILLANCE
SCANNING AND RISK ASSESSMENT.
THE CATCH BEING THAT IT'S NOT
NECESSARILY PRO-ACTIVE OR
SUFFICIENTLY RIGOROUS FOR WHAT
IS NEEDED.
SO SOME OF THOSE SUBPOINTS,
CERTAINLY A NEED FOR
INTERNATIONAL COLLABORATION,
PARTICULARLY IN LESS RESOURCE
COUNTRIES GIVEN PROXIMITY TO THE
SOURCE OF OUR BREAKS IN EMERGING
INFECTIOUS DISEASES, SO THOSE
COLLABORATIONS SHOULD FUEL
IMPORTATION OF SAMPLES, ALSO
NEEDS TO BE DEVELOPMENT OF
ASSAYS FOR LOW-RESOURCE
SETTINGS, PARTICULARLY VALUABLE
FOR HAVING THINGS LIKE LAMP OR
MOLECULAR ASSAYS FOR FIELD WORK,
FOR LOW RESOURCE PLACES.
THERE'S A NEED FOR SCALEUP OF
SURVEILLANCE, INTERFACING -- I
DON'T KNOW WHAT THIS MEANS,
APPROPRIATE DONOR SAMPLES EARLY
ON, NEED FOR INFECTIVITY
STUDIES.
ALSO, INTEGRATION OF BLOOD DONOR
COHORTS INTO KIND OF OTHER
SURVEILLANCE EFFORTS, THAT'S
OUTSIDE OF THE BLOOD COMMUNITY.
AND IN STRENGTHENING POST
DONATION INFORMATION REPORTING
SYSTEMS AND PROCESS CAPTURE.
THERE'S RISK ASSESSMENT, NEED
ONGOING RISK ASSESSMENT WITH
ABILITY TO PIVOT ACCORDINGLY SO
WE NEED TO DETERMINE A
NO-BRAINER TERMINATION OF
TRANSFUSION RISK.
IT TAKES TIME TO DEMONSTRATE.
AN EMPHASIS, REQUEST FOR ANIMAL
MODELS, WHERE -- WHICH CAN BE
USEFUL IN DETERMINING MINIMUM
INFECTIOUS DOING AND
UNDERSTANDING PARAMETERS, SO
LOOKING AT THE -- UNDERSTANDING
THE ECLIPSE PHASE VERSUS
ANTIBODY FACE, IMPACT OF
SEROCONVERSION ON INFECTIVITY
AND LOOKING AT ALGORITHMS.
THERE WAS A POINT BLOOD
TRANSFUSION IS BEING A
RELATIVELY MINOR CONTRIBUTOR TO
INCIDENCE OF INFECTION AT LEAST
IN HIGH-INCOME COUNTRIES IN A
POST-HIV ERA.
THEY MAY NOT HOLD TRUE FOR
FUTURE EIDs, NOT IN LOW- AND
MIDDLE-INCOME COUNTRIES TODAY.
LOOKS AT VIABILITY OR ASSESSING
VIABILITY OF INDIVIDUALIZED RISK
ASSESSMENTS AND DEFERRAL, SO
LOOKING AT DEFERRALS DUE TO
INFECTIOUS RISK, HOW THIS MAY
IMPACT DONORS, WILLINGNESS TO
DONATE IN THE FUTURE, ONE
EXAMPLE BEING MSM.
A NEED FOR EDUCATION OF
CLINICIANS IN VULNERABLE
POPULATIONS SUCH AS
IMMUNOSUPPRESSED.
A SUGGESTION TO CONDUCT
PRO-ACTIVE RESEARCH SUCH AS
STUDY OF THE VIROME AND AN
INTERESTING ERA, PARAMETERS OF
TOLERABLE RISK, CANADIANS CAME
UP WITH A NICE FRAMEWORK, BUT
FORMALIZING A PROCESS WHICH MAY
BE APPLICABLE IN THE U.S.
SO, PRIORITY 2 IS LEVERAGING
DONOR POPULATIONS TO STUDY EPI
AND PATHOGENESIS, TRYING TO
UNDERSTAND TO WHAT EXTENT THEY
ARE REPRESENTATIVE OF THE
GENERAL POPULATION AND DEVISING
WAYS TO ADJUST ACCORDING THIS.
THIS IS LESS OF CONCERN WITH
NOVEL AGENTS, BUT IF WE ALREADY
SCREEN FOR AGENT, MAY BE LEFT
WITH A HIGHLY BIASED CONCLUSION.
THERE'S A POINT EPIDEMIOLOGY AND
PATHOGENESIS MAY BE DIFFERENT BY
LOCATION, ASSAYS DIFFERENT
AROUND THE WORLD, HOW THAT
IMPACTS INTERPRETATION.
REALLY AN IMPORTANT POINT WHICH
WAS RAISED AND NEEDS TO BE
INCORPORATED, ESTABLISHMENT AND
MAINTENANCE OF REPOSITORIES,
SEEMS TO BE A RETICENCE TO FUND
DEVELOPMENT AND MAINTENANCE OF
REPOSITORIES THAT ENABLE THE
RESEARCH THAT'S BEING PROPOSED,
ROLLING REPOSITORIES IN SELECTED
SETTINGS, THE EXAMPLE OF BRAZIL
WHERE THEY MAINTAIN SAMPLES FOR
SIX MONTHS.
THERE WAS ALSO THE POINT THAT IT
MIGHT BE BEST TO EMPHASIZE
REPEAT DONORS OR HIGH-YIELD
DONOR SUBSETS THAT, YOU KNOW,
WHICH ARE MORE LIKELY TO PROVIDE
EPIDEMIOLOGICALLY
CROSS-SECTIONAL SAMPLES WERE NOT
FEASIBLE BUT REPEAT DONORS
FLAGGING A SUBSET OF DONORS AND
HOLDING THOSE SAMPLES FOR TWO TO
THREE YEARS MAY BE VALUABLE.
INFRASTRUCTURE IS A KEY
CHALLENGE THAT NEEDS TO BE
SPECIFIC, AND THERE WAS CONCERN
OF OVERLAP WITH NIAID OR CDC IN
THIS REGARD.
THIRD IS PATHOGEN REDUCTION OF
BLOOD PRODUCTS.
AN IMPORTANT POINT, THIS MAY
EVOLVE INTO HOMELAND SECURITY
ISSUE TO THE DEGREE THE BLOOD
SUPPLY WOULD BE THREATENED, NEXT
EID COULD BE HIGHLY TRANSFUSION
TRANSMISSIBLE, AND LOOK AT
PATHOGEN REDUCTION ON OTHER
ASPECTS OF PLATELET FUNCTION AS
IMPORTANT AS HEMOSTASIS, LIKE
IMMUNOMODULATION.
ALSO A RISK/BENEFIT OF P.R. IN
LOW AND MIDDLE INCOME COUNTRIES,
THAT'S NOT THE SAME AS
HIGH-INCOME COUNTRIES, SAME
THRESHOLD MAY NOT NECESSARILY
APPLY WHEN ONE IS DEALING WITH
HIGH INCIDENCE OF INFECTION, LOW
UPTAKE OF MOLECULAR METHODS AND
SUBOPTIMAL SEROLOGY.
RED CELL AND WHOLE BLOOD
TECHNOLOGIES ARE IN DEVELOPMENT,
THERE ARE EXPECTATIONS WITH
THINGS COMING THROUGH IN THE
NEXT YEAR OR TWO.
WITH ABILITY TO PRODUCE
COMPONENTS, IN THE CASE OF WHOLE
BLOOD.
ONE QUESTION RAISED TO WHAT
EXTENT IS THIS A RESEARCH VERSUS
COMMERCIAL ENDEAVOR?
ALSO RAISED, POTENTIAL
COLLABORATION BETWEEN NHLBI AND
BARDA, GIVEN BARDA IS FOLKED ON
PANDEMIC PREPAREDNESS WITH
FUNDING OPPORTUNITIES.
FOUR IS ENHANCED DONOR TESTING.
SO, DISCUSSED AVAILABILITY OF
MULTIPLEXED AND NEXT GENERATION
SEQUENCING METHODS.
DISCUSSED SPEED AND SCALABILITY
OF DEPLOYMENT THAT WOULD
IDENTIFY AGENTS NOT NECESSARILY
RELEVANT AND IMPACT TO DONORS,
WITH RESPECT TO GENERATING
INFORMATION, DONORS NEED TO BE
NOTIFIED ABOUT RESULTS, NOT
NECESSARILY ACTIONABLE.
TALKS ABOUT BUILDING ASSAY
PROTOTYPES AND SYSTEMS TO SCALE
AGAINST EIDs.
OBVIOUSLY NEEDS TO BE
RESTRICTIONS, TARGET SEQUENCES
TO AGENTS THAT ARE RELEVANT, IF
THIS IS OPERATIONALLY
INTEGRATED, AND HOW TO INTERPRET
FINDINGS.
AND THEN HOW DOES TESTING AND
RESEARCH CONTRIBUTE TO
OPERATIONAL DECISION MAKING, AND
BALANCE OF SEROLOGY.
PRIORITY 5, BLOOD DIFFERENCE
SUCH AS CONVALESCENT PLASMA TO
TREAT INFECTIOUS DISEASES, A FUN
DISCUSSION, LOTS OF HEATED
DEBATE.
I DON'T KNOW IF IT'S CONSENSUS
BUT I'LL SAY IT ANYWAY.
SEEMS IMPORTANT TO UNDERSTAND
THE HETEROGENEITY OF OUTPUT OF
CONVALESCENT PLASMA, LOOKING AT
CYTOKINES, ANIMAL MODELS, ET
CETERA.
AND SPECIFICALLY WHY WERE THERE
DISPARATE FINDINGS OF SIMILAR
TRIALS IN COVID-19.
THERE'S A HESITANCY TO ACCEPT
MODEL SYSTEMS IN TRANSFUSE
MEDICINE IN GENERAL FOR DECISION
MAKING.
FOR EXAMPLE, TO UNDERSTAND
RISK/BENEFITS OF A GIVEN
PRODUCT.
THERE IS, YOU KNOW, I THINK THIS
REALLY IS A RICH AREA TO STUDY,
SPECIFICALLY IN SELECTED HIGH
RISK POPULATIONS SUCH AS
IMMUNOSUPPRESSED, BUT THERE ARE
NOTABLE CHALLENGES SURROUNDING
HOW TO DEVELOP A PROGRAM OR
RESEARCH STUDY IN THE ABSENCE OF
A PATHOGEN.
AND THAT IS I THINK IT.
THANKS VERY MUCH.
THE END.
>> THAT WAS FANTASTIC.
THANK YOU TO ALL OF THE WORKING
GROUP CO-CHAIRS AND GROUP
MEMBERS FOR EFFORT IN
IDENTIFYING AND PRIORITIZING
RESEARCH PRIORITIES AS WELL AS
LEADING THE BREAKOUT DISCUSSION
WHICH THE ONE I ATTENDED I
CONCUR WAS EXCELLENT, IN ITS
SUMMARY FOR YOUR RESPECTIVE
WORKING GROUPS TODAY.
I ALSO WANT TO THANK ALL OF YOU
IN ATTENDANCE FOR YOUR ATTENTION
AND PARTICIPATION.
I FOR ONE AM GLAD TO KNOW THE
OTHER GREATOUT SESSIONS ARE
RECORDED AND CAN BE REVIEWED BY
US IN THE FUTURE.
I ALSO IN ADDITION TO YOUR
COMMUNICATIONS WITH US, WE DO
PLAN TO PROVIDE YOU WITH AN
NHLBI E-MAIL ADDRESS TO SHARE
ADDITIONAL COMMENTS OR
QUESTIONS.
I DO HOPE THAT MANY OF YOU WILL
BE ABLE TO RECONVENE WITH US
TOMORROW, HEARING FROM THREE
MORE STATE OF THE SCIENCE AND
TRANSFUSION MEDICINE WORKING
GROUPS, INCLUDES MECHANISTIC
TRANSFUSION, THAT METHODS IN
TRANSFUSION SCIENCE, DONOR AND
RECIPIENT HEALTH DISPARITIES.
THANK YOU AGAIN.
LOOK FORWARD TO RECONVENING
AGAIN TOMORROW MORNING, 10 A.M.
EASTERN TIME.