>> WELCOME BACK, EVERYONE TODAY TO THE SECOND DAY OF THE STATE OF SCIENCE AND TRANSFUSION MEDICINE SYMPOSIUM. I'M HAPPY TO SEE YOU JOIN AGAIN, AS OTHERS ARE JOINING NOW. YESTERDAY WE HEARD AND DISCUSSED RESEARCH PRIORITIES FROM THREE WORKS GROUPS FOCUSED ON BLOOD DONORS AND SUPPLY, OPTIMIZING TRANSFUSION OUTCOMES AND RECIPIENTS AND EMERGING INFECTIONS. TODAY YOU WILL HEAR PRESENTATION RESEARCH PRIORITIES FROM THREE MORE STATE OF THE SCIENCE WORKING GROUPS FOCUSED ON MECHANISTIC ASPECT OF COMPONENTS IN TRANSFUSION, NEW METHODS IN TRANSFUSION SCIENCE, AND DONOR AND RECIPIENT HEALTH DISPARITIES. AS REMINDER FOR THOSE WHO ARE NOT WITH US YESTERDAY WE ASK DURING THE PRESENTATIONS YOUR MICROPHONES REMAIN MUTED AND YOU UTILIZE THE ZOOM CHAT BOX TO ASK QUESTIONS. OR MAKE COMMENTS. MANY OF YOU SHOULD HAVE RECEIVED BIOSKETCHES ON OUR SPEAKERS. YESTERDAY AND IN PARALLEL WITH YESTERDAY'S AGENDA FOLLOWING THE THREE PRESENTATIONS BY THE WORKING GROUP CO-CHAIRS, WHETHER HE HAVE A LUNCH BREAK THEN RETURN TO PARTICIPATE IN ONE OF THREE SIMULTANEOUSLY OCCURRING BREAK OUT SESSIONS. LUNCH BREAK WE'LL PROVIDE INSTRUCTIONS THOUSAND ENTER THE BREAK OUT ROOMS AND DURING THE THE BREAK OUT SESSIONS YOU WILL HAVE THE OPPORTUNITY TO ASK QUESTIONS OR MAKE COMMENTS VIA THE CHAT BOX OR RAISE YOUR HAND THROUGH THE ZOOM PORTAL TO BE CALLED ON TO SPEAK. IN PARALLEL WITH YESTERDAY'S PRESENTATION, AFTER THE BREAK OUT SESSIONS EACH WORKING GROUP WILL PRESENT A SUMMARY OF THE DISCUSSION. WE ALSO HOPE TO HAVE SOME TIME FOR OPEN DISCOURSE AND PRESENT SOME FINAL THOUGHTS PRIOR TO CLOSING THE MEETING THIS AFTERNOON. WE ARE PLEASED TO HAVE TWO KEYNOTE SPEAKERS TO SHARE PERSPECTIVES ON STATE OF THE SCIENCE IN TRANSFUSION MEDICINE AND I WILL TURN IT OVER TO BRIAN TO INTRODUCE OUR FIRST KEYNOTE SPEAKER FOR TODAY. >> THANK YOU SO MUCH, NAREG. APPRECIATE HANDING OVER TO ME AND THANKS TO EVERYBODY FOR JOINING US AGAIN TODAY, VERY EXCITED FOR THE SECOND DAY OF THE WORKSHOP AND ALSO THE OPPORTUNITY TO BE ABLE TO INTRODUCE OUR FIRST KEYNOTE SPEAKER OF THE DAY. FIRST KEYNOTE SPEAKER IS DR. DANA DEVINE, DIRECTOR OF THE UNIVERSITY OF BRITISH COLUMBIA CENTER FOR BLOOD RESEARCH AND SHE IS THE CHIEF SCIENTIST AT CANADIAN BLOOD SERVICES. SHE WAS FORMALLY VICE PRESIDENT MEDICAL AND SCIENTIFIC SERVICES AT COMMUNITY BLOOD SERVICES, POSITION SHE HELD FOR 11 YEARS. BEFORE THAT SHE WAS DIRECTOR OF THE CANADIAN BLOOD SERVICES CENTER FOR INNOVATION. AS MANY OF YOU KNOW, SHE IS CURRENTLY THE PRESIDENT OF THE ASSOCIATION FOR THE ADVANCEMENT OF BLOOD AND BIOTHERAPIES. WE ARE THRILLED THAT DANA WILL BE HERE TODAY. SHE IS GOING TO PRESENT PRE-RECORDED REMARKS. HOWEVER SHE IS ONLINE AND WILL BE ABLE TO FOLLOW UP WITH ANY QUESTIONS ON -- AND ANSWER THOSE. WITHOUT ANY MORE WAITING LET'S PLEASE TURN IT OVER TO HEAR DR. DEVINE KEYNOTE ADDRESS. THANK YOU. >> GOOD MORNING OR GOOD AFTERNOON, WHEREVER YOU HAPPEN TO BE. THIS IS DANA DEVINE SPEAKING. I AM CURRENTLY THE DIRECTOR OF THE UNIVERSITY BRITISH COLUMBIA CENTER FOR BLOOD RESEARCH AND CHIEF SCIENTIST FOR CANADIAN BLOOD SERVICES. I WANT TO TALK TO YOU TODAY ABOUT THE IMPACT OF BLOOD DONOR VARIATION ON TRANSFUSION PRODUCT QUALITY. I THINK THIS IS AN AREA THAT IS HAS BECOME GREATER INTEREST IN RECENT YEARS. SO I HAVE A FEW DISCLOSURES. I AM A HALF TIME EMPLOYEE OF CANADIAN BLOOD SERVICES, I CHAIR THE BOARD OF MACRO PHARMA, CHAIR MEDICAL ADVISORY COMMITTEE OF RED CROSS AND MEMBER OF THE BOARD OF DIRECTORS OF STORM BIO, A BOSTON BASED STARTUP IN THE GENE THERAPY AREA WHICH WAS FOUNDED BY ONE OF MY FORMER GRADUATE STUDENTS. SO I GUESS THE QUESTION THAT WE ARE TRYING TO ANSWER FOR TODAY IS WHAT HAPPENS TO BLOOD CELLS IN STORAGE? I THINK THAT WE ALL ARE ALL WELL AWARE THAT CELLULAR BLOOD PRODUCTS DEVELOP STORAGE LESIONS OVER TIME AND THESE HAVE A NEGATIVE IMPACT ON BLOOD PRODUCT QUALITY. THIS CAN BE DEMONSTRATED BY A COLLECTION OF DATA THAT WAS PUT TOGETHER BY THE BEST COLLABORATIVE AND PUBLISHED IN 2008 IN TRANSFUSION. WHAT YOU CAN SEE IN THIS SLIDE IS SIMPLY THAT THE MINIMUM STANDARD FOR 24 HOUR RECOVERY FOR THE FDA IS 75%. YOU CAN SEE THAT THERE ARE NUMBER OF INDIVIDUALS WHO DON'T REACH THAT 75%. THIS IS A REFLECTION OF THE FACT THAT THERE'S A LOT OF VARIABILITY AMONG BLOOD DONORS AND THIS IS REFLECTED IN THE SURVIVAL RECOVERY OF THE RED CELLS. YOU CAN ALSO SEE IF YOU LOOK AT IMAGES OF RED CELLS IN STORAGE, THIS IS ADOPTED FROM ANOTHER TRANSFUSION PAPER. WHEN WE ARE TALKING BLOOD COMPONENT QUALITY WE ARE TALKING ABOUT THE IMAGES DAY ONE. BY THE THE TIME YOU HAVE GOTTEN TO DAY 21 YOU SEE A LOT OF RED CELL FORMS, THESE RED CELL FORMS ARE BLEVVING OFF FROM TIPS AND CREATING MICROPARTICLES IN THE UNIT. IF BY DAY 35 YOU HAVE RED CELLS THAT ARE SPE SPHERICAL AND COMPLETED THIS BLOOD BLEVVING PROCESS AND ON THE WAY TO LYSIS. SO THESE ARE NOT THE GREATEST RED CELLS TO TRANSPHUTS TO PATIENTS. WE CAN SEE THESE STORAGE INDUCED MICROERYTHROCYTES AND HERE YOU HAVE -- THESE ARE DAY ONE, AND HERE YOU GO ON THROUGH VARIOUS WEEKS AND YOU CAN SEE THAT WE GET THESE VERY ROUND SPHERICAL CELLS BY 42 DAYS STORAGE, THESE CELLS ARE VERY DIFFICULT TO GET THROUGH SPLENIC SINUSES BECAUSE THEY ARE ROUND SO THEY DON'T HAVE THE DEFORMABILITY CAPABILITIES THAT FRESH RED CELLS DO. WE HAVE EXAMPLES IN THIS GRAPH OF HIGH STORAGE INDUCED MICROERYTHROCYTE FORMERS AND YOU CAN SEE SOMETIMES THIS IS VERY HIGH INDEED. WE HAVE LOW STORAGE INDUCED MICROERYTHROCYTE PERFORMERS WHICH ARE THE BETTER DONORS. THERE IS ALSO AN IMPACT OF -- THIS IS DATA FROM KANIAS. THIS IS AN EXAMPLE OF STORAGE REMOLLSIS BY AGE. YOU CAN SEE THAT FEMALES ARE GENERALLY DOING BETTER IN STORAGE THAN GUYS ARE. SO THIS IS A GRAPH OF THE VARIABILITY YOU SEE IN BETWEEN THE GENDERS. OVER HERE ON THIS OTHER SIDE ARE SOME DATA THAT LOOK AT OSMOTIC FRAGILITY. YOU CAN SEE THE OSMOTIC FRAGILITY IN MEN IS IS MARKEDLY DIFFERENT THAN IN WOMEN, AS IS THE PLASMA TAC WHICH IS TOTAL -- FORGOT WHAT THE ABBREVIATION STANDS FOR. SORRY. SO THIS IS JUST WHAT WE ARE LOOKING AT THE DIFFERENCE BETWEEN GENDERS. WE ALSO SEE THIS IS WORK OUT OF MY OWN LABORATORY. WE ALSO SEE THAT YOU CAN SEE SIGNIFICANT DIFFERENCE IN BODY MASS INDEX WHICH HAS SIGNIFICANT LEVEL OF STORAGE HEMOLYSIS SO HIGHER BMI THE MORE LIKELY YOUR RED CELLS ARE TO LYSE IN STORAGE. WE ALSO SEE THESE TRIGLYCERIDE LEVELS IN DIFFERENCE BETWEEN MALES AND FEMALES, IS PARTLY ACCOUNTS FOR SOME OF THE DIFFERENCE. WHAT ABOUT PLATELET? THIS IS AN INTERESTING DATA SET PUT TOGETHER BY THE BEST COLLABORATIVE. THESE ARE DONORS DOWN HERE IN THIS RED BOX WHOSE PLATELETS FAIL PH ON ONE DONATION AND THEY ARE MORE LIKELY TO FAIL ON A SECOND DONATION. SO THESE ARE DONORS THAT WE PROBABLY DON'T WANT IN OUR SYSTEM. THEY ARE FAILING PH ON MULTIPLE OCCASIONS THROUGH SEVEN DAY QUALITY CONTROL OR FIVE DAY QUALITY CONTROL DEPENDING WHERE YOU ARE. THIS IS A SET OF POOL DATA ACROSS THE TWO CANADIAN BLOOD SERVICES, THE BRITT S OSSIES, DUTCH AND COUPLE OF AMERICAN OUTFITS. SO BLOOD SYSTEMS KNOWN AS VITALANT AS WELL AS EFS. SO THIS IS A VERY INFORMATIVE QUALITY CONTROL SET OF DATA THAT TELLS US THAT WE REALLY NEED TO GET THESE PLATELET DONORS, WHOSE PLATELETS ARE FAILING PH ON MULTIPLE DONATIONS OUT OF THE SYSTEM. SO ONE OF THE THINGS THAT MY GROUP HAS DONE IS STARTED TO CHASE AROUND BIOMARKERS TO TRY TO IDENTIFY POOR STORING DONORS. WE HAVE TAKEN A COUPLE OF APPROACHES TO THIS, WE LOOKED BY PROTEOMIC METHODOLOGIES AND SOME OF THIS IS DONE IN COLLABORATION WITH D'ALESSANDRO. WE HAVE SEEN A STRONG CORRELATION BETWEEN RAP 1 AND RHOGDI FOR THE ABILITY OF THESE PLATELETS TO GIVE REASONABLE NUMBERS ON SURVIVAL AND RECOVERY. THE OTHER QUESTION THAT BECOMES MORE RELEVANT IS DO THESE BIOMARKERS PREDICT TRANSFUSION OUTCOME IN PATIENTS SO WHAT WE DID IS A PROJECT WITH CHERYL BEFORE SHE RETIRED, THIS WAS LOOKING AT DONORS WHO CURRENTLY MET SUCCESSFULLY MET SCREENING CRITERIA. THEN WE LOOKED AT THEIR OWN SURVIVAL RECOVERY. WE RADIO LABELED THE PLATELETS OF DONORS AND RETURNED THEM TO THE DONOR. WE LOOKED WITH WHETHER OR NOT THEY HAD A GOOD OR POOR OUTCOME. WE FOUND DONORS THAT DID NOT HAVE A GOOD OUTCOME. AND WOULD NOT HAVE PASSED THE FDA MINIMUM STANDARDS. PROTEOMICS IS A VERY POWERFUL TECHNOLOGY AND OFFERS AN APPROACH TO IDENTIFY DONOR BIOMARKERS THAT ARE RELATED TO SUCCESSFUL STORAGE. WE USE PROTEOMICS TO IDENTIFY PUNITIVE BIOMARKERS AND WE NEED TO TEST THESE IN LARGE CLINICAL TRIALS. THE QUESTION IS HOW DO WE OPTIMIZE QUALITY OF DONORS GIFT. WE NEED TO ENSURE THAT COMPONENT PRODUCTION STORAGE ARE OPTIMAL, WE CAN BE FOCUSED ON IMPROVING STORAGE CONTAINERS WHICH I HAVE A GRADUATE STUDENT IN MY GROUP WHO IS WORKING ON THAT PARTICULAR PROBLEM. THEN WE HAVE A SERIES OF STORAGE SOLUTIONS WE CAN ADD TO PLATELET CONCENTRATES OR RED CELL CONCENTRATES AND TRY TO UNDERSTAND WHETHER THEY ARE GOING TO CONTRIBUTE TO IMPROVEMENT OF QUALITY OF PRODUCT. WE NEED TO UNDERSTAND DONOR APPRECIATION TO PRODUCT QUALITY AND THAT WILL ALLOW STORAGE LESION DEVELOPMENT WELL ENOUGH TO HAVE BIOMARKERS THAT GUIDE DONOR MANAGEMENT. SO WHAT WE WANT TO BE ABLE TO DO IS LOOK AT OTHER APPROACHES TO QUALITY IMPROVEMENT, WORKING ON NOVEL ADDITIVE SOLUTIONS AND WORKING TO IDENTIFY BIOMARKERS THAT IDENTIFY POOR STORING DONORS. THERE IS A NICE PAPER THAT (INDISCERNIBLE) PUB -- NAREG ROUBINIAN PUBLISHED IN JCI INSIGHTS THAT LOOKED WHETHER YOU GOT -- WHAT WERE CONTRIBUTORS TO POOR-STORING DONORS. THEY FOUND THAT THE SEX, THE RH STATUS, THE FINGER STICK HEMOGLOBIN, WHETHER OR NOT THE DONOR SMOKED, THEN STORAGE DONATION WHETHER OR NOT YOU GAMMA IRRADIATED THE COMPONENT, WHETHER OR NOT IT WAS LEUKOREDUCED, WHETHER OR NOT IT WAS AN APHERESIS COLLECTION AND THE KIND OF STORAGE SOLUTION THAT WAS INVOLVED, WERE ALSO CONTRIBUTING FACTORS. FOR THE RECIPIENT, THE SEX, THE BODY MASS INDEX, THE RACE AND ETHNICITY AND THE AGE, WERE ALL CHARACTERISTICS ASSOCIATED WITH HEMOGLOBIN. AND BILIRUBIN. SO THESE ARE THINGS WE NEED TO BE THINKING ABOUT. SO IN CONCLUSION, THE QUALITY OF BLOOD PRODUCTS IS REALLY VERY IMPORTANT FOR OUR PATIENTS, AND WE NEED TO WORK TO IMPROVE OUR APPROACH TO QUALITY ASSURANCE FOR BLOOD COMPONENTS. THIS EFFORT HAS TO INCLUDE THE DEVELOPMENT OF BETTER STANDARDS FOR COMPONENT QUALITY CONTROL AND THE IDENTIFICATION OF DONORS WHO HAVE CHARACTERISTICS THAT CAUSE REDUCED QUALITY. THOUGH I WOULD SAY THAT RIGHT NOW IN THE MIDDLE OF THE PANDEMIC WHEN WE ARE A LITTLE BIT SHORT OF DONORS MAYBE WE DON'T WANT TO IMPLEMENT THAT AT THIS PARTICULAR POINT IN TIME. SO THANK YOU FOR YOUR ATTENTION AND I AM MORE THAN HAPPY TO TAKE ANY QUESTIONS. WE DO HAVE TIME, THIS IS AN ADDITIONAL CHANCE TO HAVE DIALOGUE. I SEE WE HAVE A HAND RAISED. PLEASE GO AHEAD. >> THANK YOU FOR THAT EXCELLENT PRESENTATION. I WAS CURIOUS, ABOUT THE DONORS THE PLATELET DONORS THAT ARE FAILING PH MULTIPLE TIMES, DO WE HAVE ANY KIND OF UNDERSTANDING OR SPECULATION EVEN AS TO WHY? THAT MIGHT BE? IS IT SOMETHING THAT HAS TO DO WITH FACTORS THAT ARE EXPRESSED ON THEIR PLATELETS OR IN THEIR PLASMA? I THINK MOST PLATELETS DONORS WHO ARE FAILING MULTIPLE TIMES ARE ACTIVATED. THAT CAUSES THE PLATELETS TO HAVE A MUCH SHORTER ADULT LIFE THAN WHAT NORMALLY SEE. >> HAVE WE LOOKED AT ACTIVATION MARKERS ON THESE PLATELETS? >> YES WE HAVE. >> THIS IS THE OPPORTUNITY TO RAISE COMMENTS AT THIS POINT MORE BROADLY. THANK YOU. I SEE A HAND RAISED. I APOLOGIZE. ALL I CAN SAY IS PLEASE GO AHEAD. I DON'T KNOW YOUR FULL NAME. >> >> I HAVE A QUESTION FOR YOU. COULD YOU FOR SEE DIFFERENT DONORS YOU COULD HAVE DIFFERENT STORAGE TIMES THAT WOULD BE MANAGED BY IT? >> THAT IS WHERE WE ARE GOING TO END UP GOING. I THINK THAT FOR SOME OF THESE DONORS, WHOSE PALATALLIES DON'T STORE WELL FOR INSTANCE WERE GOING TO HAVE SHORTER STORAGE PERIODS THAN SAY FIVE OR SEVEN DAYS. AND THAT CREATES A SET OF CHALLENGES FOR THE HOSPITALS. >> THANK YOU. LOOKS LIKE WE HAVE MERLIN WHO RAISE THEIR HAND, THEN A CHAT THEN FOLLOW WITH YOU CASSANDRA. >> MANY THANKS. HOW DO YOU RECONCILE THE VALUE OF IDENTIFYING STORAGE LESIONS WHEN WE KNOW THAT SOME OF THEM ARE REPAIRED DURING CIRCULATION LIKE THE SODIUM POTASSIUM, CONCENTRATION OF D 3 PDG. >> I DO THINK THAT I'M A PLATELET BIOLOGIST PRIMARILY. SO I'M MORE FOCUSED ON WHAT IS GOING ON WITH THE PLATELET DONORS. I DO THINK THAT WHAT WE SEE IS A LARGE NUMBER OF ACTIVATED PLATELETS IN THESE DONORS THESE PLATELETS ARE ACTIVATED AND CLEARED QUICKLY IN CIRCULATION, SO I THIS I THEY ARE NOT A REALLY GOOD PRODUCT. SOME OF THESE STORAGE LESIONS GET REPAIRED IN CIRCULATION. PARTICULARLY FOR RED CELLS. >> I'M GOING TO READ THE CHAT QUESTIONS AND FOLLOW IN ORDER OF HANDS. MONICA, I DON'T KNOW YOUR LAST NAME. INTERESTING CHALLENGE, ARE POOR PLATELET DONORS ALSO POOR RED CELL DONORS? >> NOT NECESSARILY. IF YOU ARE COLLECTING PLATELETS BY APHERESIS TECHNOLOGY YOU WILL SEE THIS PHENOMENON FOR PLATELET DONORS. IT DOESN'T NECESSARILY ALSO MEAN THEY ARE POOR RED CELL DONORS. >> THANK YOU. DR. JOSEPHSON PLEASE. >> GREAT TALK. CURIOUS WHETHER, I DIDN'T SEE IT PRESENTED BUT YOU MIGHT HAVE LOOKED AT IT, BY DONORS AND PLATE LET'S, OPPOSED TO RED CELLS. WHETHER YOU FOUND OR INVESTIGATING THERE IS A SIMILAR DIFFERENCE OR NO DIFFERENCE AT ALL BETWEEN THE -- AND THE AGE OF THE PLATELET, DOES THAT MATTER. >> WE HAVEN'T LOOKED AT THAT THOUGH WE COULD. I HAVEN'T -- THE WORK WE HAVE BEEN DOING ISN'T REALLY FOCUSED IN THAT DIRECTION. I COULD EASILY GO BACK AND COUNT UP THE NUMBER OF MALE AND FEMALE DONORS AND SEE THE SAME KIND OF DIFFERENCE WE DO FOR RED CELLS. >> NEXT UP IS DR. BUSCH. >> THE CONCEPT WHAT IS IN THE BAG, WHICH IS ONE OF THE POINTS RAISED (INDISCERNIBLE) WE ACTUALLY DON'T MEASURE AT THE TIME OF ISSUE OR CERTAINLY TIME OF TRANSFUSION WHAT THE CONTENT OF RED CELLS OR PERHAPS PLATELETS ARE IN THE PRODUCTS THAT WE ISSUE. WE PACK IN A RED CELL AND NEVER QUANTIFY THE HEMOGLOBIN OR RED CELL CONTENT. SO BOTH IN TERMS OF DOSE OF RED CELLS AND PLATELETS AT THE TIME ISSUE FROM TRANSFUSION SERVICE OR QUALITY MEASURES. WHAT IS THE FUTURE DIRECTION IN THAT REGARD? >> I THINK AS PROBABLY MOST PEOPLE KNOW, THE NUMBER OF UNITS IS HIGHLY VARIABLE AND WE ARE NOT GIVING STANDARD DOSE TO PATIENTS SO THAT IS A CONCERN THAT WE DON'T HAVE A STANDARD DELIVERY SYSTEM. WE ARE GO GOING TO END UP WITH QUALITY CROW FEATURES THAT WE HAVE GOT NOW. I THINK WE ARE -- WE JUST HAVE TO GO DOWN THAT PATH OF DEVELOPING NEW QUALITY CONTROL PARAMETERS. >> THANK YOU. DR. KOR. >> FANTASTIC PRESENTATION. THANK YOU. A QUICK QUESTION OF THE CLINICAL RELEVANCE OF THE STORAGE LESION. RED CELLS CLEARLY A LOT OF INTEREST OVER TEN PLUS YEARS, 20 YEARS AT THIS POINT BUT COULDN'T FIND IT MADE A BIG CLINICAL DIFFERENCE IN PATIENTS WHO RECEIVE EXTENDED STORE RED CELLS VERSUS SHORTER STORE RED CELLS. I'M WONDERING FROM A PLATELET PERSPECTIVE, CLEARLY YOU HAVE SHOWN NICELY THAT THERE ARE SUBOPTIMAL PLATELET COMPONENTS BUT ANY SENSE WHAT THE IMPACT OF TRANSFUSED THOSE COMPONENTS TO RECIPIENTS IS ON RECIPIENT OUTCOMES? ? >> NOSE PLATELETS ARE ACTIVATED SO THEY GET CLEARED IMMEDIATELY THEY HAVE ALL ACTIVATION RECEPTORS ARE TURNED ON AND THEY GET CLEARED OUT IN THE RECEPTORS IN THE LIVER AND ALSO BY MACROPHAGES IN THE SPLEEN. THE OTHER ISSUE ABOUT THE RED CELLS IS THAT HONESTLY, NOT SURE WE REALLY KNOW. I'M VERY INTERESTED IN GETTING INVOLVED IN SOME CLINICAL STUDIES THAT WOULD TELL US WHAT IS HAPPENING. BECAUSE IF YOU LOOK PARTICULARLY IN PATIENTS WHO ARE RECEIVING CHRONIC TRANSFUSION SUPPORT LIKE THALASSEMIA PATIENTS AND SICKLE CELL DISEASE PATIENTS, I THINK IF YOU GIVE THEM A BAD UNIT OF RED CELLS, THEY ARE COMING BACK FOR ANOTHER TRANSFUSION MUCH QUICKER THAN THEY WOULD BE IF WE GAVE THEM A GOOD UNIT. >> MOSTLY THINKING INCREMENTS DANA, OPPOSED TO POTENTIAL INJURIOUS EFFECT TO AN ORGAN? >> YES, I'M THINKING THINKING T IS THE INCREMENT. I DON'T THINK WE HAVE ANY EVIDENCE THAT THESE CELLS ARE CAUSING DAMAGE TO END ORGANS >> THANK YOU. >> GREAT. WE DO SEE ADDITIONAL HANDHANDHANDS. PLEASE GO AHEAD,E YOUR NAME SO WE CAN CATCH YOUR NAME PLEASE. >> THIS IS LARRY HORASCH, CAN YOU HEAR ME? >> HI. >> HI, DANA, THANK YOU FOR THAT SUMMARY. TWO QUESTIONS FOR YOU. YOU PUT YOUR FINGER AND MIKE ALSO POINTED TO SOMETHING IMPORTANT IN A CLINICAL TRIAL WE DID SEVERAL YEARS AGO. WE HAD TO MEASURE HEMOGLOBIN IN THE BAG BECAUSE WE WERE INTERESTED IN CONSUMPTION IN THALASSEMIA PATIENTS. HEMOGLOBIN VARIED FROM 38 TO 75 GRAMS, HUGE FROM ACCEPTED DONORS. SO I THINK YOU ARE RIGHT ABOUT THAT. WE NEED TO BE MEASURING THE AMOUNT OF HEMOGLOBIN IN BAG. BUT WHAT ABOUT COLD STORED PLATELETS? WE KNOW THEY DON'T CIRCULATE WELL. WHAT ABOUT THE QUALITY CONTROL OF THOSE? >> I THINK COLD STORED PLATELETS HAVE BEEN SHOWN TO BE USEFUL FOR BLEEDING PATIENTS. YOU SHOULDN'T BE USING A PROPHYLACTIC PLATELET TRANSFUSION. THEY HAVE A ROLE BUT IT IS MORE FOR BLEEDING PATIENTS AND CARDIAC SURGERY, THAT SORT OF THING. >> I AGREE WITH THAT. TO THE MARKERS YOU LOOK AT IN COLD STORED PLATELETS TELL YOU ANYTHING ABOUT THE QUALITY OF ROOM TEMPERATURE STORED PLATELETS? >> I HAD A GRADUATE STUDENT WORK IN COLD STORED PLATELETS. HE'S FOUND VERY INTERESTING THINGS THEY WORK REALLY WELL IN -- HE'S BEEN DOING A LOT OF IN VITRO WORK AND THEY WORK WELL IN ROTEM (PHONETIC) ASSAYS BUT THEY DON'T WORK THAT WELL IN PLATELET AGGREGATION STUDIES AND THAT SORT OF THING. >> THANK YOU. >> DOCTOR, WE WILL COME BACK TO YOU IN A SECOND. THE REASON I WANT TO MAYBE JUST TURN TO THE CHAT BOX IS THIS QUESTION THAT'S BEEN RAISED BY DR. SUNNY ZEKE IS VERY MUCH CONNECTED TO WHAT WE HAVE BEEN DISCUSSING WHICH IS ACTIVATED PLATELETS ARE PRESENTED AS AN ARGUMENT IN FAVOR OF COLD STORED PLATELETS. MIGHT THE FUTURE HAVE TWO KINDS OF PLATELET LABELS BLEEDING VERSUS PROPHYLAXIS? WONDERING WHAT YOU THINK ABOUT THAT, DR. DEVINE? >> YEAH, I'M PRETTY SURE THAT MOST OF OUR HOSPITALS WILL END UP WITH DUAL INVENTORIES WHERE WE HAVE ONE SET OF COLD PLATELETS, WE ARE GOING BACK TO SOMETHING THAT ALL PLATELETS WERE STORED IN THE COLD INITIALLY WHEN FIRST DEVELOPED COMPONENT THERAPY. I THINK THAT THESE -- WE ARE GOING TO END UP GOING BACK THERE BECAUSE THESE PLATELETS ARE REALLY VERY GOOD AT PREVENTING -- HELPING PATIENTS STOP BLEEDING. I THINK THAT WE WILL HAVE TWO DOUBLE INVENTORIES IN MANY THE HOSPITALS. ONE SET OF PLATELETS THAT STORED ROOM TEMPERATURE, PLATELET SHAKER AND THE OTHER SET THAT IS STORED IN THE REFRIGERATOR. >> THANK YOU. SO DR. EICHBAUM PLEASE GO AHEAD. >> SIMILAR TO THE COLD STORAGE PLATELETS, JUST A GENERAL FOLLOW-UP QUESTION ABOUT WHAT IS THIS TELL US ABOUT WHAT WE SHOULD BE TELLING CLINICIANS ABOUT THE RESULTS OF MANY MULTI-MILLION DOLLAR, MULTI-CENTER TRIALS THAT THOUGH THEY ARE PROBLEMS WITH THESE STUDIES MOST OF THE END POINTS WERE ABOUT MORTALITY MORBIDITY ABOUT THE RED CELL STORAGE LESION THAT THERE MAY NOT BE THAT BIG IMPACT. DO WE HAVE TO RE-EVALUATE ALL THESE STUDIES? HOW DO WE LOOK AT THESE -- ALL THESE STORAGE LESIONS STUDIES? >> I THINK WE NEED TO GO BACK AND RE-EVALUATE THEM. I THINK THAT THEY ARE -- WE PUT A CERTAIN LEVEL OF INTERPRETATION ON THEM INITIALLY AND I THINK WE REALLY NEED TO GO BACK AND LOOK AT THEM AGAIN. >> THANKS. >> THANK YOU. WE HAVE ADDITIONAL QUESTION FROM -- NEED TO SCROLL BACK UP. QUESTIONS ARE STARTING TO COME IN, WHICH IS GREAT, APPRECIATE THAT. RELATED QUESTION IS THE POSSIBLE IMPACT ON STORAGE NOT ONLY ON 24 HOUR RECOVERY BUT ALSO LONG TERM RED CELL SURVIVAL. ESPECIALLY CONSIDERING TRANSFUSION NEEDS OF PATIENTS WHO REQUIRE LONG TERM TRANSFUSION SUPPORT. MORE A COMMENT BUT WONDERING IF WILL IS ASOR IN I ASPECTS >> THIS IS AN IMPORTANT ASPECT AND I THINK THAT IF WE LOOK AT WHAT IS GOING ON THERE WE SEE A SHORTENING OF SURVIVAL WITH RED BLOOD CELLS IN THESE PATIENTS WHO REQUIRE LONG TERM TRANSFUSION SUPPORT. IT IS RELATED TO DONORS. IT IS RELATED TO THE CHARACTERISTICS OF THE DONOR. >> THANK YOU ALSO SEEING QUITE A FEW QUESTIONS AROUND COLD STORE VERSUS NOT AND POTENTIALLY DIFFERENT ASPECT OF PLATELETS THEMSELVES. THAT IDEA OF POTENTIAL DUAL INVENTORY BOTH WHETHER THAT MIGHT BE PRIORITY IDENTIFIED COMING OUT OF THE STATE OF SCIENCE AND ADDITIONAL LITERATURE COMPARING PERFORMANCE IN DIFFERENT SETTINGS. SO FOR THOSE WHO ASKED THOSE QUESTIONS IF YOU DO WANT TO COME OFF AND FURTHER EXPLORE THAT, VERY HAPPY FOR YOU TO DO SO. >> I NOTICE THAT DR. SPINELLA (PHONETIC) HAS A PROMOTIONAL THING FOR HIS >> TRIAL. >> HIS TRIAL IN THE CHAT BOX AND I ENCOURAGE ALL OF YOU WHO ARE BASED IN THE STATES TO REALLY PILE IN AND TRY TO HELP THEM GET THAT TRIAL DONE. I THINK THAT IS GOING TO SHOW US SOME REALLY IMPORTANT INFORMATION. . >> THANK YOU, DR. DZIK. PLEASE GO AHEAD. >> FOLLOW UP, IT IS A GREAT TOPIC AND VERY INTERESTING AND YOU KNOW, THE POTENTIAL FOR DUAL INVENTORIES AND PROBL PROBLEMS T THAT WOULD PRESENT IN TERMS OF LOGISTICS AND CROSSING LINES AND THAT SORT OF THING MAKES IT -- AND CONSEQUENCES FOR PATIENTS MAKES IT REALLY IMPORTANT WE DEMONSTRATE COLD STORED PLATELETS STOP BLEEDING IN PATIENTS. DANA WHO I ADMIRE VERY MUCH TOSS THAT OFF. THE QUALITY OF THE EVIDENCE LOOKING AT CLINICAL BLEEDING OUTCOMES, WITH ONE PLATELET VERSUS ANOTHER IS NOT THAT ROBUST. THIS IS SUCH AN IMPORTANT BIG ISSUE THAT I THINK IT COULD BE SOMETHING NHLBI MIGHT WANT TO GET BEHIND. THAT IS NOT TO SAY THE CHIPS ARE NOT INFORMATIVE, LOOKING FORWARD TO IT AS WELL AS ANYONE. BUT MAY NOT BE THE FINAL ANSWER. WE MAY NEED MORE STUDIES IN SETTINGS OTHER THAN CARDIAC SURGERY TO DEMONSTRATE THE EFFECT IN VIVO, LEST WE FALL INTO A TRAP WE HAVE FALLEN INTO A HUNDRED THOUSAND TIMES IN THE PAST WHICH IS TO USE LABORATORY MEASURES AS SOME SORT OF TRUTH SERUM REGARDING IN VIVO EFFECTIVENESS. WHICH -- >> I COMPLETELY AGREE WITH YOU, SUNNY. >> I DO THINK BY THE WAY ADD ONE MORE THOUGHT THEN BE QUIET, WHICH EVERYONE WILL BE HAPPY ABOUT. DR. LARRY WHO IS LIKE MR. PLATELET FROM DECADES AGO, AND A GENIUS WHEN YOU LOOK BAT AT EARLIER WORK, THE GUY WAS WAY AHEAD OF HIS TIME. NOTICE WHEN YOU PUT PLATELETS IN THE COLD THEY UNDERGO FORM OF ACTIVATION THAT CAUSES THEM TO RELEASE INTERIOR THINGS SUCH AS VWF. AND FIBRINOGEN. SO WHEN YOU THEN TAKE A COLD PLATELET WITH ITS PLASMA NOW ENRICHED WITH VWF AND STICK IT IN THE ROTA MACHINE, IT IS POSSIBLE THE EFFECT YOU OBSERVE HAS NOTHING TO DO WITH PLATELETS THEMSELVES BUT THE FACT YOU CHANGED THE PLASMA ENVIRONMENT OF THOSE PLACE LETS BY HAVING THEM ENRICH THAT PLASMA FOR VON WILLEBRANDE AND ALL, AN EFFECT WHICH IS SUBSTANTIAL AND A CLOSED TEST TUBE, BUT NOT NECESSARILY BE TRUE IN VIVO WHERE THAT FLUID GETS WASHED AWAY, IF YOU FOLLOW WHAT I'M TRYING TO SAY. >> YOU ARE EXACTLY RIGHT, SUNNY >> ALL RIGHT. >> PERFECT TIMING. I DO APOLOGIZE BUT IT IS A VALUABLE DISCUSSION AND THERE'S ADDITIONAL CHAT REMARKS COMING IN. WE ARE GOING TO RECORD ALL THOSE AND MAKE SURE THEY ARE AVAILABLE FOR THE SAKE OF TIME, WE WANT TO TRY TO STAY ON SCHEDULE SO WE WILL MOVE ON. I THINK WE WILL BE INTRODUCING THE NEXT GROUP WHICH WILL BE ONE OF THE ACTUAL WORKING GROUPS. >> THANK YOU SO MUCH, DR. DEVINE FOR YOUR TALK AND ALSO ENGAGEMENT WITH THE MEMBERS WHO ARE PARTICIPATING TODAY. >> THANK YOU VERY MUCH FOR THE INHAVE IATION. >> THANK YOU, AGAIN, DANA. AS WELL. AND WE DO HOPE TO COME BACK TO THESE QUESTIONS WE NOW BEGIN GENERAL SESSION WITH THE PRESENTATION OF DRAFT RESEARCH PRIORITIES BY WORKING GROUP CO-CHAIRS, IT IS MY PLEASURE TO INTRODUCE OUR FIRST GROUP OF CO-CHAIRS, FOCUSED ON MECHANISTIC ASPECT OF COMPONENTS AND TRANSFUSIONS, OMICS EFFECTIVENESS QUALITY AND SAFETY. DR. ELDAD HOD, DEPARTMENT OF PATHOLOGY CELL BIOLOGY CLEMSON UNIVERSITY. LEADER IN TRANSLATIONAL RESEARCH FOCUSED ON RED CELL BIOLOGY AND RECIPIENT OF SEVERAL GRANTS FROM THE NIH INCLUDING PRINCIPLE INVESTIGATOR FOR THE NEW YORK HUB PROGRAM. DR. ANGELA D'ALESSANDRO, PROFESSOR DEPARTMENT OF CHEMISTRY MOLECULAR GENETICS UNIVERSITY OF COLORADO, AMONG MANY OTHER ROLES HE FILLS HE IS DIRECTOR OF MEDICAL OMICS CORE AS WELL AS MASS SPECTROMETRY SHARED RESOURCE, UNIVERSITY OF COLORADO. WELCOME TO YOU BOTH. >> THANK YOU, THANKS TO THE ORGANIZERS, NHLBI, BRIAN AND ART FOR GIVING US THE OPPORTUNITY TO CO-CHAIR THIS COMMITTEE. I APPRECIATE THE DISCUSSION WE JUST HAD BECAUSE IT GIVES US A GOOD INTRODUCTION TO THE WORK WE DID ON THIS COMMITTEE. SO JUST TO INTRODUCE YOU TO THE PROCESS WE UNDERTOOK WHEN DRAFTING PRIORITIES FOR THIS COMMITTEE. WE FORMED A COMMITTEE WITH -- IN ADDITION TO ANGLO AND MYSELF WE ASKED THE PEOPLE YOU SEE LISTED HERE TO JOIN US AND WE TRY TO GIVE PRESENTATION FROM BOTH PEOPLE WHO DO CLINICAL RESEARCH AND BASIC RESEARCH IMMUNOLOGY ALSO REPRESENTED AS WELL AS PEOPLE WITH FOCUS ON PEDIATRIC TRANSFUSION MEDICINE AS WELL AS ADULT AND PEOPLE WITH REGULATORY EXPERIENCE. WE MET SEVERAL TIMES BY ZOOM TO BRAINSTORM IDEAS AND IT BECAME APPARENT TO ANGLO AND I THAT FIVE BROAD THEMES EMERGED SO WE BROKE OUT FIVE SUBGROUPS TO DEVELOP THEMES INTO SEPARATE PRIORITY AND THEN MET BACK AGAIN LARGER GROUP TO REVIEW WHAT THE SUBGROUPS HAVE COME UP WITH AND WILL PRESENT FIVE THEMES OR DRAFT PRIORITIES TO YOU TODAY. NEXT PLEASE. SO JUST TO OUTLINE THE BROAD FIVE THEMES BEFORE WE GO INTO THEM ONE BY ONE. THE FIRST THING I WANT TO MENTION IS THAT WHEN WE DID THIS WE WANTED EACH OF THE PRIORITIES -- WE DIDN'T WANT PRIORITY TO BE REFLECTIVE OF ONE BLOOD PRODUCT LIKE RED CELL OR PLATELET, WE WANTED THEM TO BE RELEVANT TO ALL BLOOD PRODUCTS SO THAT WAS ONE OF THE THINGS WE WENT IN THINKING ABOUT WHEN WE DID THIS AND WE ALSO DIDN'T WANT THEM TO JUST BE DEDICATED TO PARTICULAR POPULATION. SO IT WASN'T LIKE ONE PRIORITY FOR NEONATAL TRANSFUSION MEDICINE. WE WANTED THAT TO ENTERCOLLATE AND BE PART OF EACH OF THE PRIORITIES WE CAME UP WITH. SO AT THE END OF THE DAY FIVE PRIORITIES, FIRST HOW TO BETTER DEFINE BLOOD PRODUCT QUALITY AND WE HAD AN EXCELLENT DISCUSSION ABOUT THAT IN THE PRIOR FOLLOWING THE KEYNOTE SPEECH. THE NEXT IS ARE THERE BETTER WAYS TO EVALUATE TRANSFUSION NEEDS AND EFFECTIVENESS. THE THIRD HAS SOME OVERLAP WITH THE SIX PRIORITY FROM YESTERDAY SECOND COMMITTEE CHAIRED BY CASSANDRA AND DARRELL, NON-INFECTIOUS SAFETY OF BLOOD PRODUCTS BE IMPROVED. THE FOURTH IS MORE IMMUNOLOGY BASED PRIORITY, WHAT STRATEGIES CAN BE EMPLOYED TO REDUCE RESPONSES TO RED BLOOD CELL OR OTHER ANTIGENS IN CONSEQUENCES OF ANTIBODIES IN TRANSFUSION AND PREGNANCY. AND THEN THE FIFTH IS HOW TO DESIGN AND TEST NEXT GENERATION OF BLOOD PRODUCTS, BLOOD DERIVED THERAPEUTICS AND HOW WE ENSURE SAFETY OF BLOOD PRODUCTS REPURPOSED FOR NON-TRANSFUSION INDICATIONS. ALSO MENTION THESE ARE IN NO PARTICULAR ORDER WE WILL PRESENT THEM IN THE ORDER THEY ARE HERE BUT THAT DOESN'T MEAN WE ARE PRIORITIZING ONE OVER THE OTHER. IN THE DISCUSSION WE WOULD LOVE TO HEAR FROM YOU, IF YOU THINK SOME ARE MORE IMPORTANT THAN OTHERS IF YOU DON'T AGREE WITH PRIORITIES NEXT PLEASE. I WILL PRESENT THE FIRST ONE, HOW TO BETTER DEFINE BLOOD PRODUCT QUALITY. WHAT THIS ENCOMPASSES IS THREE THINGS, THE FIRST IS INNOVATIVE METHODS TO ASSESS BLOOD PRODUCT QUALITY INCLUDING DEVELOPING ALTERNATIVES TO CURRENT MEASURES USED FOR QUALITY CONTROL AND REGULATORY PURPOSES. A LOT OF WHAT WE WERE TALKING ABOUT IN THE PRIOR DISCUSSION SESSION. UNDERSTANDING MECHANISMS FOR HOW QUALITY MARKERS AFFECT DIFFERENT OUTCOMES AT THE MOLECULAR AND FUNCTIONAL LEVEL AND USING NOVEL STRATEGIES TO IMPROVE QUALITY USING PERCHIZE TRANSFUSION MEDICINE APPROACHES SO THIS WILL ENCOMPASS THESE THREE IDEAS. SO WHY IS THIS AN ISSUE AND I DIDN'T PLAN THIS WITH DANA, SHE SHOWED THE SAME FIGURE FROM THE SAME PAPER SHOWING EFFECTIVELY WHAT HAPPENS WITH THE RED CELL STORAGE LESION IS AS YOU PUT RED CELLS IN A BAG, THEY START TO DETERIORATE AND WE CAN NOW MEASURE MICROERYTHROCYTES IN A RELATIVELY AUTOMATED WAY, USING FLOW CYTOMETRY. THAT IS WHERE THEY ARE SO FAR DAMAGED THEY DON'T CIRCULATE WELL. WE CAN ME MEASURE THESE THINGS, SINCE LAST DAY OF THE SCIENCE WE DEVELOPED NOVEL METHODS FOR MEASURE THESE THINGS. WE HAVE OMICS TOOLS, ME TAB ONLYIC, PROTEOMICS. THINGS MY CO-CHAIR IS EXPERT ON THAT CAN REALLY -- WE CAN DEFINE STORAGE LESION. THE GAP IN KNOWLEDGE WE STILL FACE IS WHICH OF THESE MEASURES AFFECT OR PREDICT TRANSFUSION EFFECTIVENESS. THAT IS THE ONE OF THE GOALS OF THIS PRIORITY. NEXT PLEASE. SO WHY IS THIS AN ISSUE? THE POST TRANSFUSION RECOVERY STUDY, THE CURRENT FDA GOLD STANDARD FOR RED CELLS AND PLATELETS AS WELL, THERE ARE LOT OF METHOD LOGICAL ISSUES WHETHER YOU USE CHROMIUM OR BIOTIN, THERE ARE ISSUES WITH IT THAT ARE PUBLISHED FROM HAVING DONE MANY OF THESE STUDIES THE WAY YOU EXTRAPOLATE TO T 0 AND DETERMINE WHAT STARTING POPULATION IS, IS A MATHEMATICAL CALCULATION AND SOMETIMES FLAWED ESPECIALLY WHEN YOU TAKE INTO ACCOUNT WHAT IS SPLEEN MIGHT DO AS THEY FIRST PASS THROUGH THE CIRCULATION. BUT IT IS THE GOLD STANDARD BUT IT DOESN'T NECESSARILY TELL US ANYTHING ABOUT OXYGEN DELIVERY, IMPORTANT FOR RED CELLS AND HEMOSTASIS WHICH SOMETIMES IS IMPORTANT FOR RED CELLS AND PLATELETS. OR PLASMA FOR THAT MATTER. SO IT IS THE GOLD STANDARD BUT DOESN'T TELL US WHAT IS IMPORTANT IN OUR PATIENTS. THE OTHER LAYER TO THIS, THERE'S DIFFERENT MEASURES OF QUALITY THAT MIGHT BE IMPORTANT FOR DIFFERENT POPULATIONS TO GETS AT THE CONVERSATION ABOUT COLD STORED PLATELETS, POTENTIALLY IN TRAUMA, YOU DON'T CARE ABOUT WHETHER THE PLATELETS CIRCULATE FOR 24 HOURS BUT WHAT YOU CARE ABOUT IS DO THEY GO TO SITE OF BLEEDING AND STOP IT SO THE QUALITY MEASURE FOR PLATELETS MIGHT BE -- CURRENT GOLD STANDARD QUALITY MEASURES MIGHT BE IRRELEVANT FOR COLD STORED PLATELETS. DEFINING THOSE MEASURES IN MORE OPTIMAL WAY IS PART OF THIS PRIORITY. SIMILARLY FOR CHRONIC RED CELL TRANSFUSIONS OR SICKLE CELL, YOU NEED BETTER LIFE SPAN FOR THOSE RED CELLS. POTENTIALLY AS QUESTIONED IN THE PRIOR SESSION ALLUDED TO, MAYBE OUR MEASURES ARE NOT OPTIMAL FOR THEM EITHER. NEXT SLIDE. WE ALSO NEED QUALITY MEASURES AND BETTER DEFINING THEM BECAUSE WE THINK IT WILL HELP US TO DEVELOP NOVEL PRODUCTS SO WITHOUT USEFUL QUALITY MEASURES THAT ARE REPRODUCIBLE AND EASIER TO PERFORM THAN POST TRANSFUSION RECOVERY THAT HINDERS OUR ABILITY TO DEVELOP NOVEL PRODUCTS AND ALLOW US TO BETTER QC CURRENT PRODUCTS. NEXT SLIDE. IN TERMS OF PROPOSED APPROACH, IN ALL PRIORITIES IT GOES BACK TO WHAT STEVE MENTIONED YESTERDAY, WE NEED GOOD STUDIES AND DOESN'T MATTER -- WE NEED EVERYTHING ALL TOGETHER CLINICAL STUDIES BASIC STUDIES, PRE-CLINICAL STUDIES, AND SO CLEARLY NEED MORE OF THAT. WHAT THE GROUP DID WANT TO HIGHLIGHT IS THAT THERE IS SOME COMPARATIVE EFFECTIVENESS RESEARCH AND THERE ARE DIFFERENT POPULATIONS THAT WE THINK THE QUALITY MEASURES MIGHT FUNCTION DIFFERENTLY IN THEM. SO LOOK AT THIS LIST AND IF YOU HAVE ANY COMMENTS ON THEM OR ANOTHER POPULATION IMPORTANT TO HIGHLIGHT PLEASE LET US KNOW IN THE DISCUSSION SECTION BUT WE THINK THE FOCUS SHOULD BE ON THE QUALITY -- LINKING QUALITY MARKERS WITH TRANSFUSION FOR DIFFERENT POPULATIONS AND DIFFERENT TRANSFUSION INDICA INDICATIONS. WE ALREADY HAVE STUDIES UNDERWAY THAT ARE TRYING TO LINK GENETIC AND OMICS MARKERS TO PREDICT BLOOD PRODUCT QUALITY. THERE ARE STUDIES SHOWN OBSERVATIONALLY THAT YOU CAN USE HEMOGLOBIN PLATELET, BILIRUBIN INCREMENTS TO ASSESS CERTAIN PARTS OF THE STORAGE LESION SO THEY CAN DIFFERENTIATE ON A POPULATION LEVEL YOU CAN USE THE INCREMENTS IN AN OBSERVATIONAL DATA SET TO OBSERVE THAT OLDER STORED UNITS RAISE THESE MARKERS GREATER. THERE IS A MOUSE MODEL OF RED CELL TRANSFUSION BUT WE CERTAINLY NEED MORE WORK DEVELOPING MODELS FOR THE OTHER BLOOD COMPONENTS. AND MORE WORK NEEDS TO BE DONE DEVELOPING IN IN VITRO OR EXVIVO IN SILICO MODELS TO ADDRESS THE QUESTIONS FOR ALL BLOOD PRODUCTS. I WILL HAND IT OFF TO ANGLO FOR THE NEXT PRIORITY. >> THANK YOU, ELDAD. SO THE SECOND PRIORITY IS PRETTY MUCH ALIGNED WITH THE FIRST ONE, WITH THE MINOR DIFFERENCE THAT SOMEWHAT FIRST PRIORITY NEEDS TO THE BLOOD IN CERTAIN PRIORITY, IDENTIFY THE FOCUS MORE ON EFFECTIVENESS OF RECEIVED PRODUCTS. SO SPECIFICALLY AMONG THE PRIORITIES IN THE WORKING GROUP CONSENSUS WAS REACHED ON THE NEED TO IDENTIFY BETTER WAYS TO TRANSFUSION EFFECTIVENESS. WE BELIEVE THAT NOVEL METHODS STRATEGIES NEED TO ASSESS BLOOD PRODUCT EFFICACY INCLUDING DEVELOPING ALTERNATIVE MEASURES US.WE ALSO THINK IT IS IMPORTANO UNDERSTAND MECHANISMS THAT UNDERLIE THE (INAUDIBLE) ALL BLOOD COMPONENTS. WHILE WE HAVE A CHANCE TO GO INTO DETAILS THE NEXT FEW SLIDES, OUTCOMES IDENTIFY, WE (INAUDIBLE) BLOOD CELLS POPULATION WITH INCREASE FOR PLASMA AND OTHER COMPONENTS THOUGH IT IS BEING INCLUSIVE (INAUDIBLE) PLAY A ROLE ON FORMATION, AT THAT POINT WORKING GROUPS IN PARTICULAR THE ONE LED BY DR. JOSEPHSON HAVE DISCUSSED EXTENSIVELY THE IMPACT OF ASPECTS OF -- THAT FORM THE CONTEXT OF QUALITY CONTROL OF BLOOD PRODUCTS AND EFFICACY. FOR EXAMPLE YESTERDAY IT HAS BEEN DISCUSSED THAT THE BREAK OUT SESSION FOR THE WORKING GROUP DISCUSS SIX MINUTE WALKING TEST HEART RATE IMMUNE FUNCTION, WORKING GROUP OPTIMIZING OUTCOMES FOR RECIPIENTS. AS SUCH THIS STUDY PRESENTATION FOCUS ON POTENTIAL BLOOD MARKERS FOR EFFECTIVENESS. SO THE NEED FOR NOVEL STRATEGIES TO MEASURE TRANSFUSION EFFICACY OF BLOOD PRODUCTS IS IDENTIFIED BY STRATEGIES LARGELY BASED ON FOR EXAMPLE CELLS, -- FUNCTIONAL MEASUREMENTS OF THE SUFFICIENCY OF DELIVERY OR PHYSICAL INTOLERANCE OR ANEMIA. THE GROUP -- INDUCES BLOOD PRODUCTS AND WE ARE TRYING TO MEASURE MODEL CONTENT OR ALTERNATIVE MEASURES OF POTENCY TIED TO EFFECTIVENESS OF THE PRODUCT. THE SAME CONSIDERATION APPLIES TO ACCOUNT FOR THE HETEROGENEITY OF THE BLOOD PRODUCTS. AS POINTED OUT IN THE KEYNOTE ADDRESS P. AND THE SESSION THAT FOLLOWED. AS SUCH WORKING GROUP ON THE URGENCY TO FIND NEW QUALIFIED BIOMARKERS TO IMPROVE PRECISIONS, IDENTIFY PATIENTS WHO MOST LIKELY BENEFIT FROM TRANSFUSION EITHER IN THE ACUTE OR CHRONIC CARE SETTING. PATIENTS (INAUDIBLE) SURGERY OR PATIENTS WITH ACQUIRED GENETIC ANEMIA OR THROMBOCYTOPENIA. AS I PERSONALLY ADDRESS THESE QUESTIONS, WE NOTED THAT NOVEL BIOMARKERS EFFECTIVENESS CAN BE IDENTIFIED BY TECHNOLOGY, TARGETED BLOOD DEVICE TO ASSESS FOR EXAMPLE MEASUREMENTS OF ALL LEVELS FOR SPECIFICALLY METABOLIC MARKERS OF HYPOXIA MANY IN CONTEXT OF RED CELL TRANSFUSION. ANTICIPATED FOR NEED O FOR DEVELOPMENT OF LAB -- DEVICES, FOR EXAMPLE SENSORS FOR METABOLITE TESTS, GAS METABOLITES OR OTHER FUNCTION BIOMARKERS OF EFFECTIVENESS WHO PROVIDE MECHANISTIC INSIGHT TO FUNCTIONAL IMPROVEM IMPROVEMENTS (INDISCERNIBLE). MARKERS ALSO GUIDE TRANSFUSION OF BLOOD PRODUCTS AND RED BLOOD CELLS, FOR EXAMPLE PLATELETS TEMPERATURE COLD STORED PLATELETS OR FREEZE-DRIED. WE DISCUSS A LITTLE BIT OF THIS THIS MORNING, PLASMA CAN BE -- FOR WHOLE BLOOD. NOVEL MARKERS TRANSFUSION EFFICACY FOR THIS PRODUCT, COULD COMPLIMENT MEASUREMENTS. FOR EXAMPLE DONATION THAT ACCOUNTS, MENTIONED THAT, CLASSIC (INDISCERNIBLE) POSITIVE GENERATION OR POINT OF CARE QUANTITATIVE MEASUREMENTS OF CLOTTING FACTORS FOR FIBRINOGEN LEVELS. ONE THING THE GROUP -- IS SUCH MARKERS NOVEL MARKERS SHOULD MEET CLIA CERTIFIED STANDARDS AND WHAT HAS BEEN DEFINED BEST BIOMARKERS END POINTS AND OTHER TOOLS, FOR DEVICES AND BIOMARKERS. WE BELIEVE THAT PROGRESS IN ADDRESSING THESE ISSUES EFFECTIVENESS AS OUTLINED WILL BE FEASIBLE AT LEAST BEGIN TO BE IN THE NEXT TEN YEAR YEARS. FOR EXAMPLE, CONCEPTS SUCH AS ANEMIA TOLERANCE AND IMPACT ON TRANSFUSION REQUIREMENT ARE BEING STUDIED AND DISCUSSED TO OPTIMIZE TRANSFUSION TRIGGERS. WE NEED TO BETTER DEFINE THE QUALITY FOR EXAMPLE RED BLOOD CELLS AS REPRODUCIBLY EFFECTIVE OXYGEN THERAPEUTICS BEYOND HEMOGLOBIN INCREMENTS. DEFINING EFFECTIVE HOMEOSTASIS IN CONJUNCTION WITH PLATELET, CRYOPRECIPITATE WHOLE BLOOD TRANSFUSION REQUIRE ADDITIONAL REFINEMENT. SUGGESTING P BY OTHER GROUPS THE IDENTIFICATION OF MAGIC BULLET, THERE WAS A NICE -- IN ONE OF THE BREAK OUT SESSION. MAGIC BULLET MARKERS NEEDED EFFECTIVENESS MAYBE BY THE -- TRANSFUSED PRODUCT IN SUCK COMPONENTS LIKE RED BLOOD CELLS AND BEYOND HEMOSTASIS AND GAS TRANSPORT. MEASUREMENTS MAY NOT JUST BE RELATED TO ONE PARAMETER, BUT A COMBINATION OF MEASUREMENTS PERHAPS INFORMED BY TRADITIONAL OMICS APPROACHES AND CLINICAL MEASUREMENTS IDENTIFY BY ACTIVATION INTELLIGENCE OR MACHINE LEARNING OPERATIONS OF AVAILABLE DATA AND WORKING GROUP RELATED TO THAT. NEXT SLIDE PLEASE. FINALLY TRANSFUSION BLOOD COMPONENTS MRI FOCUSING ON DIFFERENT POPULATION AS RED BLOOD CELL, FOR EXAMPLE FOCUSING ON NEONATES, CONSIDERATION CAN BE MADE FOR PATIENTS TRANSFUSION MANY THE SETTING OF TRAUMA PATIENTS OR UNDERGOING ELECTIVE SURGERY, AS POINTED OUT IN THE CHAT, CHRONIC TRANSFUSION, FOR EXAMPLE PATIENT SUFFERING FROM CRYOGENIC ANEMIA OR THROMBOCYTOPENIA. ONE I HOLD NEAR AND DEAR TO MY HEART IS CONCEPT OF PRECISE TRANSFUSION MEDICINE HAS BEEN PERSONALIZED SINCE (INAUDIBLE) TRANSFUSION EFFORTS BUT PRECISE MEDICINE APPROACHES WILL BE CLINICAL DEFINE AND VALIDATE NOVEL BIOMARKERS. THE SAME EFFECTIVENESS PARAMETERS IS TRANSFUSION OF BLOOD PRODUCTS, AGAIN IN OTHER WORDS GROUP NOTED THAT THERE (INDISCERNIBLE) TRANSDUCED PATIENTS IS BY LACK OF MARKERS THAN EFFECTIVENESS. IT IS NOTED THAT TRANSFUSION (INDISCERNIBLE) RED CELL PRODUCTS, THERE IS LIMITED BASIC CLINICAL SCIENCE IN THIS SPACE THE EXTENT TO TRY INDICATIONS UNDERWENT TO STOP TRANSFUSION. NEXT SLIDE. WITH THAT, ELDAD. >> SO THIS IS OUR NONINFECTIOUS SAFETY TRANSFUSIONED BLOOD PRODUCT PRIORITY. SO THIS ONE ENCOMPASSES IDENTIFYING COMPOUNDS AND TRANSFUSED BLOOD PRODUCTS THAT LEAD TO ADVERSE EFFECTS AND SUSCEPTIBLE RECIPIENTS, NOT NECESSARILY ALL RECIPIENTS. UNDERSTANDING THE MECHANISMS FOR HOW BLOOD PRODUCTS AND COMPOUNDS FOUND THERE IN INTERACT WITH CELLS AND ORGAN SYSTEMS AND NOVEL STRATEGIES TO IMPROVE SAFETY BY PREVENTING THE OCCURRENCE OF THE WRONG PRODUCT GETTING INTO THE RIGHT RECIPIENT OR THE RIGHT PRODUCT GETTING TO THE WRONG RECIPIENT. NEXT SLIDE. SO WHY IS THIS AN ISSUE? THERE ARE COMPOUNDS FOUND IN THE PRODUCT THAT WE CAN THEORETICALLY MEASURE AND THEY POTENTIALLY CAN LEAD TO ADVERSE OUTCOMES IN VULNERABLE PATIENTS AND THE GROUP FEELS THERE SHOULD BE MORE WORK DONE ON ESTABLISHING THIS, SO AGAIN YOU WOULD LOOK AT THE LIST WE PUT HERE AND IF THERE ARE ANYTHING YOU THINK WE ARE MISSING PLEASE LET US KNOW THESE COMPOUNDS FOUND IN THE PRODUCT COME FROM DONOR SUCH AS ANTIBODIES, THIS IS WHERE WE INCORPORATE THE ABO ANTIBODIES OR HLA ANTIBODIES OR OTHER ANTIBODIES THAT MIGHT BE IN THE PRODUCT. THERE CUB PRESCRIPTION AND NON-PRESCRIPTION DRUGS THAT ARE FOUND IN THE PRODUCT, HORMONES, HEAVY METALS, AND GENETIC VARIANTS OF CELLULAR ELEMENTS OR PROTEIN ELEMENTS THAT COULD BE IN THE PRODUCT FROM THE DONOR THAT MAY LEAD TO ADVERSE OUTCOMES IN CERTAIN RECIPIENTS. IN TERMS OF MANUFACTURING, THERE'S THE STORAGE SOLUTIONS WE USE, THERE'SPLASTISIZERS AND OTHER COMPOUNDS THAT MIGHT BE USED FOR PATHOGEN INACTIVATION THAT MAY OR MAY NOT LEAD TO ADVERSE OUTCOMES. FINALLY, THE PROCESS OF STORAGE INCREASES OR CHANGES WHAT IS IN THE BAG AND RELEASES POTASSIUM TO THE SUPERNATANT, THERE'S INCREASES IN MICROVESICALS, EXOSOMES, HEMOGLOBIN NOT IN THE RED CELL BUT FOUND OUTSIDE THE RED CELL AND OTHER RESPONSE MEDIATORS LIKEOXILIPINS TO CAUSE OUTCOMES -- ADVERSE OUTCOMES IN CERTAIN MODEL SYSTEMS. THEN THERE IS A CONCEPT OF TRIM, TRANSFUSION RELATED IMMUNOMODULATION. WE DON'T UNDERSTAND IT, WE STILL DON'T UNDERSTAND WHAT EXTENT IT HAPPENS AND WHAT CAUSES IT. BUT WE THINK THERE MIGHT BE COMPOUNDS IN THE TRANSFUSED PRODUCT THAT MAY INTERACT WITH THE RECIPIENT, RECIPIENT CELLS OR ORGAN SYSTEMS, AND THAT STUDYING THE MECHANISMS AND THE BIOLOGICAL CROSS TALK BETWEEN THE DONOR PRODUCT AND RECIPIENT SHOULD BE PRIORITY. NEXT SLIDE PLEASE. IN TERMS OF PROPOSED APPROACH. THE GROUP ALSO FELT THERE ARE -- WE DON'T NECESSARILY DO A GREAT JOB MONITORING FOR ALL THE TRANSFUSION -- HARMFUL EFFECTS AND TRANSFUSION REACTS OCCUR WITHOUT KNOWING SO NOVEL METHODS TO MONITOR FOR HARMFUL EFFECTS ARE NEEDED. WE NEED TO DETERMINE WHICH PATIENT POPULATIONS ARE MOST VULNERABLE TO THESE EFFECTS SO FOR SOME LIKE HEAVY METALS, NEONATES MIGHT BE MORE VULNERABLE. ALSO INCORPORATING SEX, RACE, ETHNICITY, GENETIC BACK GROWN OF RECIPIENT AND DONOR MAY ALSO IMPACT THIS. FROM THE REGULATORY SIDE, WE THINK THERE MIGHT BE NEED TO BE EXPOSURE LIMITS ESTABLISHED AND STANDARDS FOR CONCENTRATION OF POTENTIALLY HARMFUL COMPOUNDS DEPENDSING WHAT THE STUDIES SHOW. THEN ADDITIONAL METHODS ARE NEEDED TO IMPROVE BLOOD SAFETY TO REDUCE ERRORS IN ALL STEPS OF TRANS FUSION PRODUCT. WE SEE WRONG BLOOD IN TUBE WAY TOO OFTEN THAN IS -- MAKES ME FEEL COMFORTABLE. NEXT SLIDE. SO IN TERMS OF BARRIERS, ONE OF THE MAIN BARRIERS FOR ANY STUDIES IN PARTICULARLY AS A RESULT FORRABLE NEONATES AND CHILDREN IS MIGHT REQUIRE LONG STANDING SUPPORT FOR LONG RANGE STUDIES TO LOOK AT THE LONG TERM CONSEQUENCES. SO THAT IS A BARRIER TO DOING THOSE KINDS OF STUDIES BUT WE FEEL THAT THAT IS -- MORE SUPPORT IS NEEDED FOR THOSE TYPES OF STUDIES. MORE ANIMAL AND PRE-CLINICAL MODELS FOR BLOOD PRODUCTS NEED TO BE DEVELOPED AS IN THE OTHER PRIORITIES WE HAVE, ADDITIONAL OMICS APPROACHES, NEEDED TO PUT ALL THIS TOGETHER AND IMPLEMENTATION SCIENCE APPROACHES FOR IMPROVING SAFETY WE MOVE ON TO DRAFT PRIORITY FOUR WHICH IS WHAT STRATEGIES CAN BE EMPLOYED TO INDUCE RESPONSES TO RED BLOOD CELL OR OTHER ANTIGENS AND CONSEQUENCES OF ANTIBODIES IN TRANSFUSION AND PREGNANCY. SO THIS ENCOMPASSES THREE THINGS. FIRST IS PREVENTION STRATEGIES AND THE GROUP FELT STRONGLY THAT AN OUNCE OF PREVENTION IS WORTH POUND OF CURE AND WE SHOULD TRY WHERE POSSIBLE TO AVOID ANTIBODY FORMATION AND SO THAT WAS THE FIRST PART, SECOND ONE WAS UNDERSTANDING MECHANISMS, SO IT IS STILL MORE WORK ON -- INTO WHY SOME MAKE ANTIBODIES AND SOME DON'T. FOR RED CELLS PLATELETS AND ALSO SELF ANTIGENS VERSUS ALLO ANTIGENS, AND INCLUDING THE ROLE THAT DONOR COMPONENT CHARACTERISTICS MAY PLAY. NOVEL STRATEGIES AND THERAPEUTICS TO MINIMIZE COMPLICATIONS SO WHEN SOMEONE HAS ANTIBODY TO SOMETHING HOW CAN WE MINIMIZE THE COMPLICATIONS OR HARM THEY DO. THIS INCLUDES HYPERHEMOLYSIS WHICH IS STILL POORLY UNDERSTAND. AUTOANTIBODIES THE TO RED CELL ANTIGENS AND ANTI-BODY THES TO OTHER THINGS LIKE PLASMA LIKE IGA OR HAPTOGLOBIN TO BE INCLUSIVE OF ALL BLOOD PRODUCTS. SO WHY AN ISSUE? ALLO ANTIBODIES CAN RESULT IN HEMOLYTIC TRANSFUSION REACTIONS, DELAY OR PREVENT FUTURE TRANSFUSION SUPPORT, IT CAN POSE BARRIERS TO TRANSPLANTATION AND CAUSE OTHER SERIOUS ADVERSE EFFECTS, ONE OF THE THINGS WE DIDN'T PUTS HERE IS IT ALSO ADDS SIGNIFICANT COST IF THERE WERE NO ALLO ANTIBODIES WE WOULDN'T SPEND EFFORT AND MONEY PERFORMING TIGHTENED SCREENS, THINGS LIKE THAT. THERE IS ALSO THIS CONCEPT OF RESPONDER VERSUS NON-RESPONDSER POPULATIONS WHERE SOME PEOPLE TEND TO RESPOND AND MAKE ANTIBODIES WHEN EXPOSED TO ALLO ANTIGENS AND SOME DON'T. WE STILL DON'T UNDERSTAND THAT. THERE NEEDS TO BE MORE RESEARCH INTO DEFINING WHO IS AND ISN'T A RESPONDER. ALSO THE CONCEPT OF ANTIBODIES OF INESSENCE, MANY ANTIBODIES APPEAR AND THEN DISAPPEAR NOT DETECTABLE BY AGGLUTINATION METHODS SO WE DON'T DETECT THEM IN BLOOD VEIN AND AS PATIENTS GO FROM BLOOD VAIN TO BLOOD VAIN IF WE DON'T HAVE A METHOD FOR TRACKING E. CXFC ANTIBODIES SOMETIMES EXPOSE PEOPLE TO ANTIGENS THAT HAD WE HAD THEIR HISTORY WE COULD HAVE AVOIDED SO UNDERSTANDING THE PROCESS OF EVANESCENCE AND WHEN CLINICALLY SIGNIFICANT IS IMPORTANT. WHEN YOU CHALLENGE SOMEONE WHO HAS ALLO ANTIBODIES, OR AUTOANTIBODIES FOR THAT MATTER, WHY SOME PEOPLE HAVE CLINICAL SYMPTOMS WITH IT AND SOME DON'T, WE STILL DON'T KNOW. SO UNDERSTANDING THAT MECHANISTIC IS ALSO THE GROUP FELT WAS IMPORTANT. NEXT SLIDE. SO THE GROUP FELT AGAIN THAT PREVENTION STRATEGIES ARE OUT MOST IMPORTANCE. WE NEED MORE WORK DONE ON BETTER MATCHING BASED ON MOLECULAR PHENOTYPES AND MORE WORK DONE ON MOLECULAR GENOTYPING. ADDITIONAL BASIC TRANSLATIONAL AND CLINICAL STUDIES TO STUDY MECHANISMS UNDERLYING IMMUNIZATION. SEVERITY OF TRANSFUSION REACTIONS AND THERAPEUTICS TO MINIMIZE COMPLICATIONS. T NEXT SLIDE. TERMS OF BARRIERS, ONE OF THE MAJOR BARRIERS IS THAT ALLO IMMUNIZATION IS A RELATIVELY RARE EVENT, HARD TO PREDICT WHEN SOMEONE WILL HAVE OCCURRENCE OF ALLO ANTIBODY. WE NEED TO DO A BETTER JOB BUILDING BIOBANKS WITH FLOW ANNOTATED BIOSPECIMENS, SPECIMENS THAT ARE AVAILABLE BEFORE SOMEONE MAKES AN ANTIBODY. WE NEED BETTER INFORMATION SYSTEMS AND DATA SHARING TO DOCUMENT ANTIBODIES ACROSS THE STATES. THINGS THAT ARE MAYBE ROUTINE A IN OTHER COUNTRIES. WE NEED ADDITIONAL HEMOTOLOGY GENOMICS TOOLS TO BE ABLE TO DEAL WITH THIS INFORMATION. FINALLY, AGAIN AS A MAIN BARRIERS THAT WE NEED COLLABORATIVE NETWORKS AND POTENTIALLY REGISTRIES TO REALLY MAKE A DIFFERENCE IN -- FOR THIS PRIORITY. NEXT SLIDE. SWITCH BACK TO ANGLO. >> SO LAST BUT TESTING AND DESIGN AND THE TEST THE NEXT GENERATION OF BLOOD PRODUCTS BLOOD DERIVED THERAPEUTIC. AND IMMEDIATE TO ENSURE SAFETY OF NOVEL BLOOD PRODUCTS OR EVEN BLOOD PRODUCTS REPURPOSED FOR NON-TRANSFUSION INHIBITIONS. -- INDICATIONS. AS NOTESSED BY YESTERDAY, MULTIPLE WORKS GROUPS PRIOR SESSIONS THE GLOBAL PANDEMIC, COVID-19 PANDEMIC HAS EXACERBATED ISSUES IN THE BLOOD SUPPLY CHAIN. HURDLES IN DONOR RECRUITMENT AND SUBSEQUENT SCARCE BLOOD RESERVES HAVE PERSISTED IN EARLY 2022 DESPITE EASING OF THE PANDEMIC. EFFORT TO DEVELOP NOVEL BLOOD PRODUCTS EXTEND SHELF LIFE, QUOTHMENT OR EVEN REPLACE CURRENT PRODUCTS ARE OF INCREASED IMPORTANCE. MULTIPLE APPROACH WERE IDENTIFIED TO TRANSFER THE BLOOD, DEVELOPMENT OF EXVIVO GENERATED BLOOD CELLS FROM STEM OR PROGENITOR CELLS OR INDUCED PLURIPOTENT STEM CELLS OR ADULT UMBILICAL CORD BLOOD ORIGIN, SYNTHESIS OF ARTIFICIAL BLOOD CELLS, ERYTHROCYTES OR PLATELETS, THE USE OF BLOOD CELLS AS TRANSFUSION WERE NOTICED. SUCH AS THE USE OF BLOOD CELLS, SPECIAL EMPHASIS ON BLOOD CELLS AS DELIVERY SYSTEMS. FOR EXAMPLE ENZYME LOADED RED BLOOD CELLS FOR METABOLIC INTERVENTIONS IN CANCER. NEXT SLIDE PLEASE. THE DEVELOPMENT OF BLOOD PRODUCTS ENCOMPASS SIGNIFICANT GOALS, FORWARD TO QUALITY SAFETY AND EFFICACY AND PERHAPS SHELF LIFE OF FROM DR. DEVINE BLOOD GIFT. AS PART OF THE APPROACHES THE GROUP INCLUDED HIGH THROUGH PUT OMICS THAT ARE DEVELOPMENT OF NOVEL STRATEGIES OR ADJUVANTS FOR RED BLOOD CELLS PLATELETS WHOLE BLOOD PRODUCTS. IN ADDITION THE RESEARCH TEMPERATURE MENTIONED IN MISPRESENTATION BEFORE, FOR -- THROMBOSOMES, THE OPTIMIZATION OF MANAGEMENT APPROACHES FOR EXAMPLE HYPOXY STORAGE RED BLOOD CELLS WHOLE BLOOD. WHILE THE SARS COV-2 TRANSFUSION IS NOT REPRESENT CRITICAL ISSUE IN THE LATEST PANDEMIC, WE MAY NOT BE SO LUCKY THE NEXT PANDEMIC. PROVIDED IMPLEMENTATION OF PATHOGEN RELEASED PRODUCTS WILL BE BY DEVELOPMENT OF SPECIFIC -- POTENTIAL EMPHASIS OF PATHOGEN REACTION PROCESS. AS PART OF THE DISCUSSION WE ALSO BOTH CONTROL -- BRIEFLY DISCUSS DEVELOPMENT OF UNIVERSAL BLOOD PRODUCTS, FOR EXAMPLE ENZYMATIC TREATMENTS IN BLOOD GROUP ANTIGEN OR MORE BRIEFLY, WE DISCUSS PERCENT BLOOD GIVEN RECENT BREAK THROUGH IN CONDITION TO HUMANS. IN PARALLEL TO DEVELOPMENT OF NOVEL BLOOD PRODUCTS, NOVEL USE OF CORED BLOOD PRODU PRODUCTS ARE EMERGING. FOR EXAMPLE POOR PLASMA OR PLATELET GELS IN COSMETIC, RHEUMATOLOGY, SPORTS MEDICINE, EMERGENCY MEDICINE. IN BURN PATIENTS AND TRAUMA PATIENTS. STUDIES BY RODENT MODELS FOLLOWED BY MORE RECENT STUDIES ON TRANSFUSION OF PLASMA FROM YOUNG DAUGHTERS AND RECIPIENTS PROVIDE TRANSFUSIONAL BLOOD PRODUCTS FOR ANTI-AGING PURPOSES. FINALLY, COVID-19 PANDEMIC REVIVED INTEREST IN USE OF CONVALESCENT PLASMA FOR PROPHYLACTIC OR ACUTE DISEASE, OPENING KEYNOTE LECTURE NOTESSED HOW (INAUDIBLE) IF NOT FOR THE NEXT EPIDEMIC. NEXT SLIDE PLEASE. SO FOCUS THERE DESCRIBE BEGINNING TO DESCRIBE WOULD BE POSSIBLE WITHIN THE NEXT THREE TO TEN YEARS, STUDIES WOULD NEED TO (INAUDIBLE) AT THE TIME, AS PART OF THE STUDIES EXISTING ANIMAL MODELS ANIMAL MODELS WOULD BE NECESSARY. CAN BE UTILIZE THE DEVELOPMENT OF PRODUCTS WHICH CAN BE TESTED IN TRIALS. WITH RESPECT TO DEVELOPMENT OF EXVIVO GENETIC BLOOD PRODUCTS ONE ISSUE IDENTIFIED RELATED TO FOR EXAMPLE, HOW THOSE CELLS FUNCTION INCLUDING COST EFFECTIVENESS AND SAFETY, DIFFERENTIATION AMONG -- FOR EXAMPLE IN MANIPULATION -- ENUCLEATION OF ERYTHROID PRECURSORS. DEVELOPING STANDARDS AND QUALITY CONTROL METHODS FOR THESE NOVEL PRODUCTS IS CRUCIAL. SO THIS FINAL SLIDE SUMMARIZES THE PRIORITY OF WORKING GROUP OF COURSE AS DR. HOD MENTIONED, SEE THERE'S BEEN ACTIVITY IN THE CHAT, AND WE WILL BE HAPPY TO DISCUSS THIS IN THE BREAK OUT SESSION. THAT SHOULD BE AROUND 12:35 TO 1:35 P.M. AND THANK YOU ALL FOR YOUR ATTENTION. THANKS FOR THE OPPORTUNITY TO PRESENT TODAY AND SPECIAL THANKS TO THE WORK TO PUT ALL THIS TOGETHER AND OF COURSE ADD TO THE PRIORITIES ADDITIONAL PRIORITIES THAT WERE IN THESE WELL IDENTIFIED AS PARTS OF THE DISCUSSION AND PATH FORWARD. THANK YOU. >> THANK YOU SO MUCH DR. HOD AND D'ALESSANDRO, LOTS OF OPPORTUNITY TO COME BACK AND DISCUSSION DURING THE BREAK OUT SESSION AND LATER ON. I WILL MOVE TO THE NEXT WORKING GROUP. THAT IS AN INTERESTING WORKING GROUP, WE ASK THEM TO TACKLE A LOT OF DIFFERENT THINGS. THIS WORKING GROUP IS BEING CHAIRED BY DR. RUCHIKA GOEL AND DR. JANSEN SEHEULT, NEW METHODS TRANSFUSION SCIENCE, DATA SCIENCE MULTI-FACTORIAL ANALYSES, USE OF ARTIFICIAL INTELLIGENCE AND MACHINE LEARNING. SO AGAIN, THOSE ARE THE CHAIRS, THE CO-CHAIRS, DR. GOEL IS ASSOCIATE PROFESSOR IN PEDIATRICS HEMATOLOGY ONCOLOGY AT SIMMONS CANCER INSTITUTE AT SIU AS WELL AS ADDITIONAL ROLES AT JOHNS HOPKINS UNIVERSITY AND IMPACT LIFE AND DR. SEHEULT IS SENIOR CONSULTANT PROFESSOR IN DIVISION OF PATHOLOGY, COMPUTATIONAL PATHOLOGY AND ARTIFICIAL INTELLIGENCE, DEPARTMENT OF LABORATORY MEDICINE AT THE MAYO WHICH I IN THIS CASE IN ROCHESTER. SO THANK YOU. PLEASE GO AHEAD. >> THANK YOU SO MUCH, DR. CUSTER FOR THE INTRODUCTION. WE ARE GRATEFUL TO NHLBI FOR GETTING A CHANCE TO CO-CHAIR A SUBGROUP. AND ALSO WE ARE THANKFUL FOR NOVEL EMERGING DATA SCIENCES AND COMPUTATIONAL METHODS IN BLOOD BANKING TRANSFUSION MEDICINE TO BE RECOGNIZED AS AN INDEPENDENT SUBGROUP. NEXT SLIDE PLEASE. SO AS WE THINK ABOUT THE RESEARCH PRIORITIES THE NEXT FIVE TO TEN YEARS, WHY IS DATA SCIENCE IMPORTANT? DOES IT DESERVE A SEPARATE ROLE IN IDENTIFICATION? SO JUST LOOKING AT THE BACKGROUND, APPLICATIONS OF THE VARIOUS NEW DATA SCIENCE TECHNIQUES SUCH AS ANALYTICS, ARTIFICIAL INTELLIGENCE AND MANY SHEEN LEARNING AND MULTI-OMICS TO BANKING TRANSFUSION MEDICINE IS STILL IN THE RELATIVE INFANCY, DATA ANALYTICS CAN BE KEY TO PROPOSED ASSOCIATIONS FOR BETTER MECHANIC DECISIONS AND HELP IDENTIFY PREDICT PATTERNS AND TRENDS THAT WERE PREVIOUSLY UNKNOWN AND THOSE INFORM FUTURE STUDIES AS WELL AS INTERVENTIONS. HOWEVER, DESPITE A LOT OF BUZZ, LOTS OF NEWER COMPUTATIONAL METHODS ARE RELATIVELY UNDERUTILIZED ANDs SEW TEARIC CONCEPT BUT ONLY IN TRANSFUSION MEDICINE BLOOD BANKING BUT IN GENERAL ADOPTION IN HEALTHCARE IS SLOW AS COMPARED TO COMPANIES WHICH ARE TECH AND HIGHLY DATA DRIVEN BUSINESS SECTORS WE HAVE ADAPTED THEM MUCH FASTER. SO I THINK TIME IS RIGHT TO IDENTIFY AND AS WELL AS APPLY SOME OF THESE NEW NOVEL TECHNOLOGIES AND DRIVE INNOVATION IN THE FELTED. -- FEEL. OUR SUBGROUP -- FIELD. OUR SUBGROUP AS SOME ATTENDEES WILL NOTICE BRINGS TOGETHER A LOT OF PROPOSED APPROACHES FROM MANY STATE OF THE SCIENCE WORKING GROUPS AND EXCELLENT PROPROPOSALS PUT FORTH. AS DR. CUSTER MENTIONED ONE CHALLENGE WE FACE AS WE TRY TO COME UP WITH DRAFTING RESEARCH PRIORITIES WAS THAT DO WE USE EACH DATA SCIENCE TECHNIQUE AND PROPOSED THAT AT ITS OWN RESEARCH PRIORITY OR IDENTIFY RESEARCH GAPS WHERE THE DATA SCIENCE TECHNIQUES COULD BE APPLIED. WE HAVE COME WITH A HYBRID MODEL, WE HAVE ONE RESEARCH GAP THAT COULD BE SOLVE BY PROPOSING VARIOUS DATA SCIENCE TECHNIQUES OR ONE DATA SCIENCE TECHNIQUE THAT COULD BE APPLICABLE TO MORE THAN ONE RESEARCH GAP COMING UP WITH PROPOSED DELIVERABLES. HERE IS OUR WORKING GROUP AND WE HAVE BEEN FORT MAT THE UNIQUE STRENGTH OF THE GROUP IS HALF THE TEAM MEMBERS ARE PRIMARILY BASED IN CLINICAL TRANSFUSION MEDICINE, OTHER IS COMPOSED OF TECHNICAL DATA SCIENCE EXPERTS RANGING FROM GENOMICS INFORMATICS, BIOSTATISTICS AND DATA SCIENCES, ARTIFICIAL INTELLIGENCE AND MACHINE LEARNING AND THESE ARE EXPERTS FROM U.S. AND CANADA. SO THANK YOU SO MUCH FOR ALL THEIR TIME. NEXT SLIDE. FOR OUR METHODOLOGY SIMILAR TO GROUP AS ELDAD PRESENTED WE HAD A LOT OF CONVERSATIONS FIVE THEMES THAT BROADLY EMERGED. BASED ON COMBINATION OF APPLICATION AS WELL AS ANALYTIC TECHNIQUES. WE IDENTIFIED SUBGROUP LEADS AND RESPONSIBILITIES, AND LEADING TEAMS WERE ARTIFICIAL INTELLIGENCE AND MACHINE LEARNING. INFORMATICS, DATABASE CURATION, DATA VISUALIZATION AND BIG DATA RESEARCH. DEMAND FORECASTING AND BLOOD SUPPLY CHAIN MANAGEMENT. PERSONALIZED TRANSFUSION MEDICINE AND COST EFFECTIVENESS. OMICS AND SYSTEMS BIOLOGY IN BLOOD BANKING. SO WHAT WE CAN SEE HERE IS WE TRY TO -- DATA SCIENCE CATEGORIES TO VARIOUS SUB MEMBERS NEXT SLIDE. BUT THIS LOT OF EXPERTISE AND IDEAS ARE FLUID AND OVERLAPPING BUT YOU WILL SEE AS WE PRESENT RESEARCH PRIORITIES. NEXT SLIDE. SO THIS IS THE SUMMARY OF FOUR PRIORITIES. RIGHT NOW NO SPECIFIC ORDER. JANSEN WILL GO OVER RANKING STRATEGY BUT LOVE TO HEAR INPUT DURING THE BREAK OUT SESSIONS AND BEYOND AND THE RANKING SHOULD BE FLEXIBLE. SO SUMMARIES ARE USE OF INFORMATION COMMUNICATION TECHNOLOGIES, ICT AND SOCIAL MEDIA TO BETTER UNDERSTAND BLOOD DONOR BEHAVIOR. DEVELOPMENT AND USE OF MULTI-DIMENSIONAL RANGE OF DATABASES AND VISUALIZATION TECHNIQUES AND BLOOD BANKING IN TRANSFUSION MEDICINE. DATA DRIVEN ECONOMIC EVALUATIONS IN BLOOD BANKING TRANSFUSION MEDICINE. DEPLOYING ROBUST SCALABLE ARTIFICIAL INTELLIGENCE MACHINE LEARNING WORK FLOWS. INTEGRATING GENOMICS INTO CLINICAL TRANSFUSION WORK FLOWS USE OF IN SILICO CLINICAL TRIALS, AS WELL AS MULTI-MODAL AI AND MACHINE LEARNING WITH PHENOMMIC DATA. SO MOVING ON TO FIRST PRIORITY. THIS USING INFORMATION COMMUNICATION TECHNOLOGIES OR ICT AND SOCIAL MEDIA TO BETTER UNDERSTAND BLOOD DONOR BEHAVIOR. ALTHOUGH ICT SOCIAL MEDIA ARE CONCEPTUALLY DIFFERENT THEY ARE INTERTWINED AND INEXTRICABLY CONNECTED SO OUR QUESTION IS, HOW CAN SOCIAL MEDIA, AND OTHER ICT TECHNOLOGIES BE USED TO BETTER UNDERSTAND DONOR MOTIVATION, VARIOUS DONATION AND HELPING INCORPORATE THOSE TO FACILITATE DONOR RECRUITMENT. WHY AN ISSUE? COMMUNICATION TECHNOLOGY SUCH AS MAIL, TELEPHONE TEXT MESSAGING AND EMAIL USED IN RECRUITING BLOOD DONORS FOR DECADES AND THESE REMAIN PRIMARY CHANNELS OF COMMUNICATION FOR BLOOD CENTERS AND DONORS. ACADEMIC AND MARKETING AND SOCIOLOGY DEVELOPED TECHNIQUES FOR ADVANCING UNDERSTANDING HUMAN BEHAVIOR THROUGH THE LENS OF SOCIAL MEDIA. THESE TECHNOLOGIES PROVIDE A NOVEL YET UNTAP POTENTIAL TO UNDERSTAND DONOR BEHAVIOR AS WELL AS ENGAGE IN DONOR RECRUITMENT AND COORDINATION. WHAT IS PROPOSED APPROACH? WE LIKE TO PRESENT A RECENT EXAMPLE AS WELL. WE CAN USE THE ICT AND SOCIAL MEDIA PLATFORMS, TO REPLACE, SAY COMPLIMENT AND/OR REPLACE OLDER COMMUNICATION TECHNOLOGIES AND ESPECIALLY TARGET CERTAIN GRAPHICS, THE YOUNGER DONORS AS THESE PLATFORMS OFFER DEEPER MORE INTEGRATED CONNECTIONS AND AUTOMATION AND ADAPTED LEARNING BETTER THAN THE OLDER TECHNOLOGIES. THERE ARE RECENT SUCCESSFUL EXAMPLES THE BLOOD DONATION TOOL USED TO CONDUCT THE FIRST LARGE SCALE ALGORITHMIC MATCHING OF BLOOD DONORS. I WILL SHOW THE NEXT COUPLE OF SLIDES AND THIS SHOWS THE FIRST MODEL OF DEPLOYMENT IN BLOOD BANKING LARGE SCALE. THE GOEL WILL BE TO USE THIS PLATFORM AS OPPORTUNITIES FOR THE BLOOD CENTERS TO RECRUIT DONORS AND ALSO FOR THE DONORS TO IDENTIFY COMMUNITY AMONG THEMSELVES. THERE ARE ALSO NEWER NOVEL TECHNOLOGIES SUCH AS VIRTUAL OR AUGMENTED REALITIES WE HAVE BRILLIANT EXAMPLES AND NEWER TRIALS COMING UP FOR DONOR ENGAGEMENT AND ENHANCED EXPERIENCES. NEXT SLIDE. THIS SLIDE IS ADAPTED FROM -- WHO LED THIS WORK UNIVERSITY OF MARYLAND AND FACEBOOK FOR DEVELOPING LARGE SCALE ALGORITHMIC MATCHING FOR BLOOD DONATION, WHERE THE BLOOD DONORS AS THE NEED AROSE RECEIVE NOTIFICATION ABOUT THE DONATION OPPORTUNITIES AND HOW AND WHERE TO DO SO. THIS DID HAVE A GO LIVE IN 2017, STARTING WITH INDIA AND TO DATE BY EXAMPLE MORE THAN 35 MILLION PEOPLE WHO DID SIGN UP TO BE BLOOD DONORS ACROSS THE COUNTRIES AS LISTED. FOLLOW-UP IN PERSON SURVEYS IN SOME OF THESE COUNTRIES HAVE SHOWN THAT IN ONE TO FIVE DONOR SET THAT THE BLOOD DONATION TOOL DID INFLUENCE POSITION TO GIVE BLOOD. LOOK AT EXAMPLES FEASIBILITY AS WELL AS BARRIERS, YES, THERE IS FEESIBILITY BECAUSE TECHNOLOGIES ALLOW PERSON REAL TIME COMMUNICATION, WITH ENORMOUS AUDIENCES TO VARIETY OF MEDIA INCLUDING TEXT, RADIO IMAGES AN OPPORTUNITY FOR REACTION AND INDIVIDUAL IMPROVED MESSAGES. ON SOME OF THESE MODERN PLATFORMS USERS TEND TO ENGAGE WITH GROUPS RATHER THAN INDIVIDUALS WHICH ALSO WAS MENTIONED BY OUR BLOOD DONORS AND SUPPLY SUBGROUP BY DR. BRIGHT, THIS YOURS TRULY FOR COLLECTIVE CONSCIOUSNESS FOR NOVEL SOCIAL DYNAMICS. THERE ARE BARRIERS, TO BE TAKEN CARE OF, SO AS THESE TECHNOLOGIES ARE CONSTANTLY EVOLVING, ONGOING RESEARCH WILL BE NEEDED TO UNDERSTAND THE CHANGING ONLINE SOCIAL DYNAMICS. ONLINE PRIVACY BREACH OF INFORMATION FOR THESE MODALITIES ALWAYS REMAINS IMPORTANT ESPECIALLY SOME OF THEM THERE IS CONCERN FOR DEEPLY SHARING PERSONAL INFORMATION. THERE IS ALSO A NEED TO ACCOUNT FOR DONOR CONCERNS, PARTICULARLY RELATES TO NOTIFICATION FATIGUE, IN ADDITION SOME OF THESE COLLECTIVE CONSCIOUSNESS TECHNIQUES CAN HAVE POSITIVE AND NEGATIVE EFFECTS ON INDIVIDUALS AS WELL AS COMMUNITY SO LARGELY REMAINS TO BE STUDIED WHY THESE REMAIN INCORPORATED. OUR SECOND PRIORITY IS USING MULTI-DIMENSIONAL DATABASES AND DATA VISUALIZATION TOOLS AND BLOOD BANKING. THE QUESTIONS ARE, HOW CAN SOME OF THE MULTI-DIMENSIONAL DATABASES FIRST BE CURATED AND UTILIZED TO ANSWER RESEARCH QUESTIONS IN SOME OF THE SPECIFIC POPULATIONS, DR. -- MENTIONED SEVERAL TIMES THE POPULATIONS OF INTEREST AND THE SAME APPLIES, ABILITY OF HAVING SOME BIG DATA MULTI-DIMENSIONAL DATABASES DOES ALLOW THAT TO BE STUDIED. WE CAN ALSO STUDY RARE OUTCOMES AN EXPOSURES. HOW CAN YOU BEST UTILIZE DATA VISUALIZATION TOOLS TO EVALUATE AS WELL AS IMPROVE QUALITY IN DATA MANAGEMENT. SO WHY IS THIS IMPORTANT? TO DATE THERE IS LIMITED AVAILABILITY OF COMPREHENSIVE VEIN TO VEIN DATABASES WHICH CONTAIN INFORMATION ON DONORS, BLOOD COMPONENTS, AS WELL AS TRANSFUSION RECIPIENTS. THESE DATABASES PROVIDE KEY INFORMATION FROM MANY OBSERVATIONAL STUDIES AND ENABLE INVESTIGATORS TO ADDRESS EMERGING RESEARCH QUESTIONS. AS FAR AS DATA VISUALIZATION GOES MANY CURRENT EXTEND DATA VISUALIZATION TECHNIQUES HAVE BEEN STATIC AND TEND TO FOCUS ON SINGLE CENTER. WHILE THESE PROVIDE USEFUL FOCUS SUMMARIES ON PERFORMANCE DATA, THEY MAY NOT ALLOW FOR ENHANCE CONTEXT OR FLEXIBILITY AT HIERARCHICAL LEVELS FOR A DEEPER UNDERSTANDING. WHAT IS THE PROPOSED APPROACH? IT WOULD BE DEVELOPMENT OF COMPREHENSIVE VEIN TO VEIN DATABASES WHICH CONTAIN THIS INFORMATION. INCLUSION OF NON-TRANSFUSED CONTROLS IN PATIENT DATABASE COMPARATIVE EFFECTIVENESS STUDIES AREN PRO. UTILIZING MODELS I WILL TALK IN THE NEXT SLIDE INCLUDING OBSERVATIONAL MEDICAL OUTCOMES PARTNERSHIP OR OMOP COMMON DATA MODEL TO ALLOW'S OF COMBINING MULTIPLE VEIN TO VEIN DATABASES, SO WELL DESIGNED DATABASES AND THE DATA ANALYTICS PIPELINE CAN REALLY ENABLE THE DEPLOYMENT OF DATA VISUALIZATION TOOLS ACROSS MULTIPLE CENTERS. AND THIS CAN ALLOW INTRAAND INSTITUTIONAL BENCHMARKING OF PERFORMANCES USING A FEDERATED MODEL, SOMETHING JANSEN WILL ELABORATE ON. IN ADDITION, THE ADVANCE DATA VISUALIZATION APPLICATIONS FOR PATIENTS LIKE MINE, IT CAN ALLOW VISUALIZE PERFORMANCE IN OUTCOMES OF PAST PATIENTS, THAT IS SIMILAR TO UPCOMING PATIENT AND SERVE AS PERSONALIZE RISK ASSESSMENT TOOL. I WANT TO GIVE THIS EXAMPLE, FROM THE ODYSSEY WEBSITE SHOWING VERY SIMPLISTIC VIEW OF THE OMOP COMMON DATA MODEL WHICH ALLOWS SYSTEMATIC ANALYSIS OF VARIOUS DISPARATE OBSERVATIONAL DATABASES AND TRANSFORMS THE DATA WITHIN THESE DATABASES INTO A COMMON FORMAT OR A DATA MODEL. AS WELL AS COMMON REPRESENTATION USING THE TERMINOLOGIES, VOCABULARIES AND CODING SCHEMES. THEN NEXT STEP PERFORMS SYSTEMATIC ANALYSIS, USING A LIBRARY OF STANDARD ANALYTIC ROUTINES. THAT HAVE BEEN BASED ON THIS COMMON FORMATS. ALSO WANT TO GIVE AN EXAMPLE OF NON-STATIC PATIENT LED MANAGEMENT DATA VISUALIZING TOOL DEVELOPED BY (INAUDIBLE) DR. (INAUDIBLE) TEAM WHICH ALLOWS REAL TIME TRACKING AS WELL AS TRANSFUSIONAL BENCH MARKING. SO FEASIBILITY AND BARRIERS, DATABASES HAVE BEEN SUCCESSFULLY CREATED, THE RED THREE STUDIES INCORPORATED IT WELL, SO THERE ARE EXAMPLES. THE BENEFITS OF USING INCORPORATING SOME OF THE NEWER DESIGNS FOR EXAMPLE THE OMOP COMMON DATA MODEL CURRENTLY DOING, REALLY ALLOWS COMBINING THE DATA FROM VARIOUS DATE OPERADISPARATE SOURCES ONCE INCORPORATED THE MODEL CAN BE INTERROGATED BY IDENTIFYING NEW DATA MAPPINGS SUCH AS LABORATORY METHODS BEYOND CLINICAL APPLICATIONS. FURTHER DEPLOYING THE DATA VISUALIZATION TOOLS, IS BECOMING INCREASINGLY FEASIBLE WITH USE OF OPEN SOURCE AND/OR CHILD BASE SOLUTIONS. THIS CAN BE FACILITATED BY STANDARDIZE DATABASE STRUCTURE. THERE ARE BARRIERS INCLUDING NEED FOR DATA USE, SIGNIFICANT BARRIERS IN HARMONIZING THE DATA SETS, CURRENTLY USED NOVEL SYSTEMS SUCH AS THE LOGIC OBSERVATIONAL IDENTIFY FOR AGGREGATING THE LABORATORY DATA AND ALSO DEPLOYING REAL TIME DATA AGGREGATION PIPELINES. IN ADDITION ONCE THIS IS DONE DEFINING VALIDATED METRICS TO I ALLOW MEANINGFUL COMPARISON IS A KEY CHALLENGE. OUR NEXT PRIORITY IS USE OF DATA DRIVEN ECONOMIC EVALUATIONS AND BLOOD BANKING AND TRANSFUSION MEDICINE, AND HOW TO USE APPROACHES TO IMPROVE ACCURACY AS WELL AS APPLICABILITY ECONOMIC EVALUATIONS TO OUR COMMUNITY. WHY IS THIS AN ISSUE? COST EFFECTIVE ANALYSES, PERFORM FORMAL ASSESSMENT OF TRADE OFFS WHICH INFORM BENEFITS, HARMS AND COSTS INHERENT AS KEY IN ANY ALTERNATIVE OPTIONS. IT IS NOT COMPLETELY NEW TO TRANSCRIPTION MEDICINE BUT IN OTHER SCENARIOS AS WELL IT IS USED TO INFORM PUBLIC AND PRIVATE ORGANIZATIONS, INCLUDING DECISIONS BENEFIT DESIGNS AND PRICE NEGOTIATIONS. MODEL BASE ECONOMIC EVALUATION, SYNTHESIZE EVIDENCE AND REVEAL TRADE OFFS BETWEEN POLICY ALTERNATIVES WHEN FORM -- AND USE ALLOW EFFECTIVE AS WELL AS PATIENT USER HELD RESOURCES AND ALLOCATIONS. THERE HAVE BEEN SEVERAL ECONOMIC EVALUATIONS WHICH FOCUS PRIMARILY TRANSFUSION INFECTIONS ALL NOTABLY NON-INFECTIOUS TRANSFUSION CAN ACCOUNTS FOR MOST TRANSFUSION ASSOCIATED MORBIDITY AND MORTALI MORTALITYS AN EXAMPLE FROM PARTICIPANT, THIS SLIDE ADAPTED FROM SOME OF THE WORK ON (INAUDIBLE) ALSO AN AWARDEE WORKING AT STUDYING THIS ISSUE WHERE YOU SEE THAT THERE ARE STUDIES DATING MORE THAN 20 YEARS PLUS WHICH ASSURE DATA DRIVEN ECONOMIC EVALUATION FROM COST ANALYSES CAN REPRODUCIBILITY COMPARATIVE EFFECTIVENESS STUDY, COST CONSEQUENCE AND UTILITY ANALYSIS. SO WHAT WOULD BE THE PROPOSED APPROACH? WOULD BE FOR IN OUR TRANSFUSION MEDS SIN BLOOD BANKING, DERIVE BETTER MODEL BASE ECONOMIC EVALUATION, TO SYNTHESIZE EVIDENCE AND TRADE OFFS BETWEEN POLICY ALTERNATIVES, USE DECISION TREES AND MODELS WHICH MODEL DIFFUSION RECIPIENTS AS A HOMOGENOUS POPULATION AND MODELS AGAIN RESOURCES FOR EXAMPLE PUBLICATION AND LITERATURE. THE DECISION MODELING CAN BE USED TO INFORM DONOR ELIGIBILITY AND DEFERRALS, MODELS CAN BE USED TO CONTINUALLY REASSESS THE BLOOD SAFETY PORTFOLIO. IN ADDITION THE DATA APPROACHES DIRECTLY ANALYZE PATIENT LEVEL DATA AS PART OF THE DECISION ANALYTIC MODEL. THESE APPROACHES CAN BE REDUCE BIAS IN POPULATION LEVEL ESTIMATES AND ENABLE ANALYSIS OF POLICY IMPLICATIONS AS WELL AS FACILITATE MODEL BASE ECONOMIC EVALUATIONS OF INTERVENTIONS, NON-INFECTIOUS TRANSFUSION REACTIONS. FEASIBILITY IS AS WE MENTION SOME OF THESE STUDIES HAVE BEEN ATTEMPTED IN VARIOUS SCENARIOS PREVIOUSLY AND THERE IS INCREASE AVAILABILITY OF HIGH PERFORMANCE COMPUTERS AS WELL AS CLINICAL AND ADMINISTRATIVE BILLING DATA SYNCED ON TRANSFUSIONED PATIENTS ENABLE MORE DATA DRIVEN EVALUATIONS. RISK MODELS AND DECISION ANALYSIS INFORM EFFECTIVE BLOOD SAFETY POLICIES. SOME OF THE BARRIERS ARE ACCESS WE NEED TO LARGER DATA SETS, COMPONENT EXPOSURE AND OUTCOMES. DATA DIRECTLY ESTIMATE ADVERSE EVENT IN DONOR DATA AS WE THINK OF THE LONG TERM IMPLICATIONS AND ECONOMIC EVALUATION INTO ACCOUNT, SOME DATA TAKES YEARS TO ACCUMULATE ESPECIALLY -- THOSE ARE TOUGH ONES TO ACCOUNT FOR BY COST EFFECTIVENESS ANALYSIS. ALSO IN THE U.S. MULTI-CARE SYSTEM MULTI-SOURCES MAYBE NEEDED TO AGGREGATE TO ENSURE REPRESENTATIVENESS. NOW PASS TO JANSEN TO DISCUSS QUALITY. >> WE HAD NUMBER OF AI AND MACHINE LEARNING EXPERTS IN OUR GRUEL IN CLINICAL DOMAIN AND TECHNICAL EXPERTISE AN DATA SCIENCE AN ENGINEERING. WE STRUGGLED WITH THE AI PRIORITY AND FOCUS OF SCOPE BECAUSE AI IS A LARGE FIELD RIGHT NOW. SO ONE OF THE THINGS WE STRUGGLED WITH IS AI IS NOT NOVEL OR NEW THOUGH WE THINK OF IT AS A NEW CONCEPT, NEW THING THAT IS HAPPENING IN THE LAST DECADE, THE (INAUDIBLE) WAS DEVELOPED IN THE 50s, BACK PROPAGATION SINCE 1960s AND MODIFIED IN 1980s. SO THE CONCEPTS OF DEEP LEARNING AND MACHINE LEARNING ARE NOT NEW, THEY HAVE BEEN AROUND FOR DECADES BUT WHAT WE DO HAVE ARE IMPROVEMENT IN COMPUTATIONAL POWER, AND ALSO ACCESS TO DATA ON SCALE AND SHAPE NEVER SEEN BEFORE. SO YOU CAN THINK OF AI AS A PIPELINE, AI MODEL IS INTEGRATED IN THIS PIPELINE THAT INCLUDES PREANALYTICAL FACTORS OR PRE-MODEL FACTORS. AND ALSO POST MODEL FACTORS. WE WANT TO TRY TO TAKE THIS FROM A BIRD'S EYE VIEW HOLISTIC VIEW OF AI AND BLOOD BANKING TRANSFUSION MEDICINE AND COME UP WITH AN OVERARCHING PRIORITY. SO THE QUESTION WE CAME UP WITH CLINICAL SERVICES AND BLOOD BANKS EVALUATE ADOPT AI TOOLS PREDICTING PATIENT TRANSFUSION REQUIREMENT, BLOOD UTILIZATION AN DEMAND FORECASTING. HOW WE CAN ENSURE THOSE TOOLS ARE GENERALIZABLE ROBUST AN SCALABLE. THIS HAS BEEN FACILITATED BY THE IMPROVEMENT IN COMPUTATIONAL POWER AND CONNECTED INTEROPERABLE HEALTH DATA PIPELINES. WE ARE SEEING A NUMBER OF RESEARCH AND TRANSLATIONAL APPLICATION OF A AI ML TRANSFUSION ANALYTICS AND BLOOD DEMAND FORECASTING. TWO MORE COLLISION. THESE ARE -- CLICKS. THESE ARE DATA RESEARCH APPLICATIONS PUBLISHED IN TRANSFUSION MEDICINE DOMAIN, ARTIFICIAL INTELLIGENCE BASE PREDICTION OF TRANSFUSION IN ICU, APPLICATION DECISION TREE ALGORITHMS, PREDICTION MASSIVE TRANSFUSION TRAUMA. THEN MORE TRANSLATIONAL, SOMETHING THAT IS GOING FOR FDA APPROVAL IS AI ENABLED ADVANCE DEPLOYMENT, LOOKING AT COMPENSATORY RESERVE MACHINE LEARNING ALGORITHMS. THERE ARE ALSO FEW APPLICATIONS IN THE BLOOD BANKING DOMAIN, THIS ONE STUDY REDUCTION OF PLATELET OUTDATING AND SHORTAGE BY FORECASTING DEMAND WITH THE COMBINATION OF STATISTICAL LEARNING AND DEEP NEURAL NETWORKS. ONE OF OUR WORKING GROUP MEMBERS PUBLISHED THIS QUITE FANTASTIC PAPER ON DEMAND FORECASTING WHICH INCORPORATED BOTH STATISTICAL MODELING AND MACHINE LEARNING FOR INVENTORY OPTIMIZATION. THEN RUCHIKA MENTIONED THE FACEBOOK AI BLOOD DONATION TOOL. THIS WAS A QUICK OVERVIEW OF SOME OF THE RESEARCH APPLICATIONS POPPING UP IN THE LITERATURE. SO FOR THIS OVERARCHING GOEL DEPLOYING ROBUST SCALE GENERALIZABLE RISK-BASED APPROACH IS IDEAL WHICH BALANCES THE DISEASE STATES SEVERITY AND DECISION CONSEQUENCE. GOING ON TO FOCUS PRIORITY ON IMPLEMENT -- PLEA AGREEMENT TAKES RESEARCH ON DATA AVAILABILITY SOURCING FOR ALGORITHM EVALUATION. A STATISTICAL FRAMEWORK FOR MODEL VALIDATION VERIFICATION. PERFORMANCE MONITORING FOR DRIFTS OR SHIFTS OVER TIME. HUMAN COMPUTER INTERACTION AND MODEL CHANGE CONTROL. WE ALSO WANT TO FOCUS ON TWO TECHNIQUES WHICH ARE RELATIVELY NOVEL. FIRST ONE AROUND ENSEMBLE LEARNING BUT UTILIZED MORE IN BLOOD BANKING AND TRANSFUSION MEDICINE RECENTLY. SO USING MULTIPLE MODELS WHICH ALL HAVE THEIR OWN PROS AND CONS. TO ARRIVE AT A BETTER PREDICTION. WE ALSO WANT TO FOCUS ON FEDERATED LEARNING SO THE PRINCIPLES OF FEDERATED LEARNING ARE DECENTRALIZATION, DISTRIBUTION, SECURE AGGREGATION, AND ALL THOSE FACTORS CAN REDUCE CLIENT LATENCY, IMPROVE THE HUMAN COMPUTER INTERACTION, PROVIDES TOOL FOR DOING VERIFICATION. PROTECTS PRIVACY, HOUSING DATA LOCALLY. MUSCLE ROBUSTNESS AND GENERALIZABILITY, THE AIM WAS TO FOCUS ON USE OF ENSEMBLE LEARNING FEDERATED LEARNING TECHNIQUES ACHIEVING THE OVERASH.ING AIM OF ROBUST SCALABLE AI. SO THE FEASIBILITY ISSUES OF ROBUSTNESS SCALABILITY RELIABILITY, WE THINK CAN BE ADDRESSED WITHIN 3 TO 10 YEARS BECAUSE DATA INFRASTRUCTURE WIDELY AVAILABLE. EACH OUR VENDORS -- EPISICK SEPSIS MODEL WE AREN'T AWARE OF KNOWN IMPLEMENTATIONS IN BLOOD BANKING AND TRANSFUSION MEDICINE. ENSEMBLE AND FEDERATED METHODS ARE RELATIVELY NEW BUT THEY HAVE BEEN APPLIED QUITE A LOOT MEDICAL IMAGING AND OTHER CLINICAL USE CASES, THEY DO HOLD SIGNIFICANT PROMISE FOR TRANSFUSION MEDICINE BLOOD BANKING. THERE ARE PROBLEMS WITH INTEROPERABILITY AND AGGREGATION, SOME ALLEVIATED BY HAVING BETTER DATABASE DESIGN. SOME WILL ALSO BE ALLEVIATED AS SOFTWARE VENDORS GRAPPLE WITH COMPLIANCE WITH THE FIREMAN DATE. THE REACH OF THE MANDATE MAY NOT EXTEND BEYOND PATIENTS TO BLOOD DONOR AND REIMBURSEMENT IS ONGOING CONCERN AND PATHOLOGY AND RADIOLOGY RIGHT NOW. MOSTLY IM ALGORITHMS RECEIVE CATEGORY 3 CPT INITIALLY AND GETTING PAIRS TO REBUST FOR THESE MODELS IS CHALLENGING. FOR THE FIFTH PRIORITY WE LEVERAGE EXPERTISE OF OUR TWO GENOMICS EXPERTS, SELENA AND BILL, I DON'T HAVE EXPERTISE BUT I WILL PRESENT THEIR PRIORITY THEY DRAFTED FOR US. SO THE QUESTION HOW CAN WE BETTER INTEGRATE GENOMICS CLINICAL TRANSFUSION WORKFORCE WITH OBJECTIVE PROVIDING THE BEST DONOR FOR RECIPIENT, IN CLINICAL TRANSFUSION? GENOMICS HAS POTENTIAL TO ENHANCE NATIONAL RARE BLOOD INVENTORY IMPROVE ALLEGATION OF BLOOD DECREASE UTILIZATION, OPTIMIZE CLINICAL RESPONSE AN SAFETY. >> TWO MINUTE WARNING. >> GROWING EVIDENCE BASED DEMONSTRATED ADVANTAGES OF GENOMIC TESTING, CRITICAL FACTORS FOR BROAD UPTAKE OPTIMAL BIOINFORMATICS PIPELINE CREATION OF VALIDATION DATA SETS WITH RARE DIVERSE SAMPLES, ISSUES OF EQUITY AND RACIAL DIVERSITY, INCORPORATION OF LONG RANGE SEQUENCING GLOBAL CURATED ALLELE FREQUENCY DATABASES AND INTEROPERABILITY. APPLICABILITY OF THE PIPELINES TOOLS AN APPROACHES NEED TO BE SYSTEMATICALLY TESTED, THERE ARE POTENTIALLY UNTAPPED GENOMICS APPLICATIONS SUCH AS ALLO ORGANIZATION, AUTO-IMMUNITY, HYPERHEMOLYSIS, PERMIZED BLOOD DONATION SCHEDULES, DISCOVERY DATA SCIENCE CAN BE CROWD SOURCED USING GRAND CHALLENGES THOUGH WE HAVE TO GET AROUND PRIVACY. THERE IS A ROLE FOR MULTI-CENTER CLINICAL TRIAL. FEASIBILITIES, TOOLS ARE AVAILABLE IN OTHER DOMAINS AND INCREASELY AVAILABLE IN BLOOD BANGING TRANSFUSION BUT AT SLOW PACE. THERE ARE PLATFORMS AVAILABLE FOR CROWD SOURCE GRAND CHALLENGES, THERE ARE CONCERNS ABOUT PRIVACY, INTEROPERABILITY AND AGGREGATION. QUICKLY GLANCE OVER TWO ADDITIONAL PRIORITIES. FIRST WAS IN SILICO CLINICAL TRIALS, THE FADS PLACED A LARGE EMPHASIS ON -- FDA PLACED LARGE MODELING AND SIMULATION IN DEVICE APPROVAL PROCESS AN CLINICAL TRIALS. THIS ONE IN SILICO TRIALS OFFER INNOVATIVE APPROACH TO EVALUATING COMPARATIVE EFFICACY AND SAFETY, MODELING AND SIMULATION USE TO PREDICT PERFORMANCE, EXPLORE ALTERNATIVE STUDY DESIGNS, NOVEL EFFECTIVE THERAPEUTICS, SO THE QUESTION HERE WAS CAN IN SILICO CLINICAL TRIALS BE US YEW TO IDENTIFY PATIENT SUB GROUPS MOST LIKELY TO BENEFIT FROM RECESS STATION STRATEGIES, GUIDE INCLUSION AND EXCLUSION CRITERIA FOR CLINICAL TRIALS AND IMPROVE STATISTICAL POWER. THE OTHER PRIORITY WAS CHANGING THE PARADIGM OF AI ML, WE HAVE A TOP DOWN APPROACH, WE FRAGMENT THE PROBLEM TO SMALLER PROBLEMS, REFORMULATING THAT BOTTOM OR CONNECTIONIST APPROACH, COMBINING SINGLE MODEL AND SYSTEMS THAT BUILD UP TO FORM MORE COMPLEX MODELS. SO JAMES WORKED ON THIS PRIORITY FOR US, A SYSTEMS BY BIOLOGY EXPERT, HOW TO CREATE MULTI-MODAL AI THAT LEVERAGES DATA USING SYSTEMS BIOLOGY. TO INTEGRATE KNOWN MECHANISTIC DATA AND MOLECULAR DATA. HOW CAN THIS BE USED TO INTEGRATE DOMAIN KNOWLEDGE OF BIOCHEMICAL PATHWAYS AND IMPROVE PREDICTIVE ANALYTICS. WHAT WE USED WAS THE RICE SCORING METHOD, USED IN TELECOMMUNICATION, WE ADAPTED IT SLIGHTLY BUT USES FOUR FACTORS THE REACH, NUMBER OF INDIVIDUALS PRIORITIES LIKELY TO EFFECT THE IMPACT CONFIDENCE OF FEASIBILITY ACCOMPLISHED AND EFFORT NECESSARY TO IMPLEMENT PRIORITY. WE MADE A SLIGHT MODIFICATION BY SWEARING THE EFFORT TO GET VALUES TO BE CLOSER TO VALUE OF 1. THIS ADDRESSES STRIP PLOT HOW OUR WORKING GROUP MEMBERS RANKED ALL THESE SEVEN PRIORITIES IN ORDER THEY WERE PRESENTED TODAY SO THE FIRST FIVE PRESENTED WERE RANKED HIGHEST. LAST TWO ARE CONSIDERING ADDITIONAL PRIORITIES. SOME VARIABILITY, TECHNICAL EXPERTS RANKED IN SILICO CLINICAL TRIALS HIGHER THAN OTHER PRIORITIES BUT IN THE END WE CAME UP WITH A GOOD OVERALL RANKING FOR THE SERVE PRIORITIES. SO THIS HERE IS ANOTHER SUMMARY, THESE ARE OBVIOUSLY OPEN FOR REPRIORITIZATION BASED ON DISCUSSION MANY THE BREAK OUT SESSION. WE WANT THE THANK OUR 11 WORKING GROUP MEMBERS, THEY CRIBBED TO DISCUSSION AND HELPING DRAFT PRIORITIES. WE WELCOME DISCUSSION AND QUESTIONS IN THE BREAK OUT SESSION. THANK YOU. >> >> THANK YOU CLEAR RESEARCH PRIORITIES WHICH ENCOMPASS THE EXPERTISE OF YOUR WORKING GROUP I NOW ARE HAVE THE PRIVILEGE OF INTRODUCING DR. YVETTE MILLER AND MEGHAN DELANEY, DONORS IN TRANSFUSION MEDICINE. DR. -- IN CHARLOTTE, NICK NICK SHE SERVED IN MULTIPLE LEADER SHIP ROLES FOR THE AMERICAN RED CROSS AND AABB AND RECOGNIZED FOR HER LONG STANDING COMMITMENT TO ADDRESSING HEALTH DISPARITIES AND STRUCTURAL RACISM AND BIAS IN HEALTHCARE. DR. MEGHAN DELANEY IS CHIEF DIVISION OF PATHOLOGY, DIRECTOR OF CHILDREN'S NATIONAL HOSPITAL AND PEDIATRICS GEORGE WASHINGTON UNIVERSITY. WELCOME TO BOTH. >> GREAT. THANK YOU. SO MUCH. AGAIN WE WANT TO -- WE WANT TO THANK NHLBI FOR TAPPING US TO TALK ABOUT THIS IMPORTANT TOPIC ON DONOR BLOOD RECIPIENT HEALTH DISPARITIES. THIS IS A SPECIAL TIME AND SPECIAL PLACE TO BE TO HAVE THIS DISCUSSION IN GENERAL IN THE SCIENTIFIC LITERATURE, AND SPECIFICALLY IN TRANSFUSION MEDICINE, THERE HAS NOT BEEN MUCH DISCUSSION AROUND HEALTH DISPARITIES AND INHE CAN IS SO WE UNDERSTAND THAT THIS IS AN INCREDIBLE OPPORTUNITY TO BE INNOVATED TO HAVE THIS DISCUSSION. WE WANT TO THANK NHLBI AND BRIAN FOR TAPPING US AND INVITING US TO THIS SPACE. NONE OF THIS COULD HAVE BEEN DONE. WITHOUT THIS FANTASTIC GROUP OF INDIVIDUALS THAT HELP US THAT WORKED WITH US TO PUT THIS INFORMATION TOGETHER. MEGHAN AND I WERE DELIBERATE AN INTENTIONAL AND FOCUSED ON PUTTING A CROSS CULTURAL TEAM OF VICTIMS THAT HE WANT ARED DIFFERENT AREAS OF CERTAIN DIVERSITY IN TERMS OF ETHNICITY AND BACKGROUND BUT ALSO EDUCATION AND EXPERIEN EXPERIENL THESE INDIVIDUALS REPRESENT EXCELLENCE IN THEIR FIELDS. SO FIRST PRIORITY WAS REGARDING INCLUSION AND RESEARCH. HOW CAN DIVERSITY OF RESEARCH PARTICIPANTS FOR EXAMPLE RACE SOCIOECONOMIC STATUS AN LANGUAGE, BE INCREASED FOR BOTH BLOOD DONOR STUDIES AND STUDIES OF PATIENTS. WHAT IS THE PROBLEM WE ARE DESCRIBING? RACIALIZED ECONOMICALLY DEPRIVED COMMUNITIES HAVE POOR HEALTH OUTCOMES. THIS IS SOMETHING WE KNOW FROM THE LITERATURE, THE PUBLIC HEALTH LITERATURE AS WELL AS ASPECT FROM THE SCIENTIFIC LITERATURE. DONORS DIVERSITY OF THE DONOR POOL IS IMPORTANT FOR SUFFICIENCY BUT ALSO RARE BLOODS TYPES. STUDIES IN WHICH SUCH COMMUNITIES ARE UNDER-REPRESENTED, MAY IDENTIFY EFFICACY OF RESEARCH IN MORE ADVANCE MORE ADVANTAGED COMMUNITIES BUT MISIDENTIFYING EFFECTS IN COMMUNITIES MOST IN NEED. STUDIES DIVERSE DONORS OR POTENTIAL DONORS ARE UNDER-REPRESENTED RESULT IN RECRUITMENT STRATEGIES AND DONOR CRITERIA THAT DON'T ADDRESS RECOGNIZE IN THOSE SPECIFIC COMMUNITIES. SO WHY AN ISSUE? EXCLUSION OF MINORITIES RESULTS IN UNEQUAL RESOURCE ALLOCATION FOR TREATMENT OR DONOR RECRUITMENT APPROACHES THAT BENEFIT SOME MORE THAN OTHERS AND LESS EFFORT BEING PUT INTO THE ALLOCATION OF TREATMENT THAT BENEFIT MORE DIVERSE GROUPS. ONE OF THE ISSUES, FEW WORDS ABOUTIUS OF TERM MINORITIES. IN CONVERSATION WITH COMMUNITY DIVERSE COMMUNITIES AND SOME SPECIFIC INTERACTIONS HAVE BEEN WITH THE SICKLE CELL DISEASE COMMUNITY, AND COMMUNITIES THAT ARE GREATER RISK FOR HAVING SICKLE CELL DISEASE, THEY ARE MOVING AWAY FROM SELF IDENTIFYING AS MINORITY BECAUSE WE KNOW THAT IN THE TERMS OF POPULATION, IN THIS COUNTRY ARE THE COUNTRY IS BECOMING MORE DIVERSE AND WHEN THE NEXT 10 TO 15 YEARS THE WHITE POPULATION IN THIS COUNTRY WILL NOT BE THE DOMINANT CULTURE. SO WE ARE ABSOLUTELY MOVING AWAY FROM IDENTIFYING GROUPS, COMMUNITIES OF COLOR, UNDER-REPRESENTED COMMUNITIES, AS MINORITIES BUT WE ARE GOING TO CONTINUE TO USE THAT LANGUAGE IN THIS PRESENTATION BECAUSE THAT IS THE LANGUAGE MOST PEOPLE ARE USING NONOW. BUT TRAJECTORY IS MOVE ON FROM IDENTIFYING UNDERREPRESENTED POPULATIONS AS MINORITY. IN TERMS OF FEASIBILITY AND BARRIERSK SPECIFIC STUDIES ON DIVERSE COMMUNITIES SHOULD BE FUNDED AND SPECIFIC FUNDING ANNOUNCEMENTS TO DEVELOP PROJECTS BY DIVERSE RESEARCHERS. IF YOU DON'T KNOW THESE RESEARCH PROJECTS AND FUNDING IS AVAILABLING IT IS NOT WIDELY PUNILY SIZED YOU DONE KNOW -- PUBLICIZED YOU DON'T KNOW IT IS AVAILABLE. MEMBERSHIP OFTY VERSE RESEARCHERS INCLUDES MENTORING FROM START TO FINISH OF A PROJECTED, AND OPENNESS TO DIFFERENT WAYS OF EXPRESSING RESEARCH PLANS. SO WE UNDERSTAND LOOKING AT THE SCIENTIFIC LITERATURE IS MONOLITHIC IN TERMS HOW ARTICLES ARE WRITTEN SO SO BRINGING DIVERSE COMMUNITIES IN, THERE'S DIVERSITY OF THOUGHT AND PRESENTATION SO WE NEED TO RESPECT THAT. QUALITATIVE APPROACHES AND INTERDISCIPLINARY COLLABORATION SUPPORTED BECAUSE THESE WILL ENHANCE INCLUSIVITY. SODS ONE OF THE THINGS WE DO WITH PRIORITIES IS THAT WE LIST DISCUSSION QUESTIONS. WHILE WE KNOW YOU WILL ABSOLUTELY BE DROPPING THOUGHTS AND QUESTIONS IN THE CHAT WE WANTED CONVERSATIONS STARTERS. SO WHAT PART DOES MISTRUST PLAY IN THE INABILITY TO RECRUIT RESEARCH PARTICIPANTS FOR UNDER-REPRESENTED COMMUNITIES. WHAT TRUST BUILDING TECHNIQUES EMPLOYED AND DOES TRUTH RECONCILIATION MODEL HAVE A PLACE? USING CRISPER TECHNOLOGY AS AN EXAMPLE, SCIENTISTS EMPLOYING THESE TECHNIQUES MAY HAVE CONTACT WITH INDIVIDUALS THAT MAYBE RESEARCH SUBJECTS AND ULTIMATELY THE PATIENTS THAT WILL BE TREAT WITH THIS TECHNIQUE. IS THIS EXERTING UNDUE INFLUENCE ON PATIENT? AND HOW CAN THE CONFLICT OF INTEREST BE ADDRESSED? PRIORITY 2, ACCESS TO CARE. ACCESS TO APPROPRIATE TRANSFUSION CARE CAN BE LIMITED BY CHURL NORMS, FINANCIAL AND GEOGRAPHICAL BARRIERS. HOW CAN THESE BARRIERS BE OVERCOME? WHAT IS THE PROBLEM GEOGRAPHY PLAYS A NEGATIVE ROLE IN ACCESS TO CARE FOR PEOPLE WITH SICKLE CELL DISEASE AND OTHERS WHO NEED TRANSFUSION IN EMERGENCY SESSION SITUATIONS. IN 2010, 55% OF BLACK AMERICANS LIVED IN SOUTH AND 105 SOUTHERN COUNTIES HAD A BLACK POPULATION OF 50% OR GREATER. WHILE IN GENERAL, COMMUNITIES WITH HIGHER PERCENTAGES OF INDIVIDUALS FROM UNDER-REPRESENTED UNDERRESOURCED COMMUNITIES WHAT WE DO KNOW IS THEY HAVE DECREASE ACCESS TO CARE. AND RURAL HEALTHCARE HAS TRADITIONALLY LAGGED BEHIND THAT IN URBAN AREAS. SO THE PICTURE CHANGED DRAMATICALLY OVER THE PAST DECADE, DUE TO TRANSFORMATION OF FINANCING, INTRODUCTION OF TECHNOLOGIES AND CLUSTERING OF HEALTHCARE SERVICES AND RESOURCES TO SYSTEMS AND NETWORKS OFTEN PRIMARILY SITUATED IN URBAN CENTERS. DESPITE CHANGES, RURAL RESOURCES FOR RURAL HEALTH SYSTEMS REMAIN RELATIVELY INSUFFICIENT. AND UNCHANGED. RURAL COMMUNITIES CONTINUE TO EXPERIENCE SHORTAGES OF PHYSICIANS AND HEALTHCARE PROVIDERS IN GENERAL. AND PROPORTION OF RURAL HOSPITALS UNDER FINANCIAL STRESS AND STRAIN IS MUCH GREATER THAN THAT URBAN HOSPITALS. FOR PEOPLE WITH SICKLE CELL DISEASE LIVING IN RURAL AREAS, THERE ARE CHALLENGES, GREATLY AMPLIFIED UTILIZATION OF RESOURCES AND SERVICES IS DIRECTLY RELATED TO SOCIAL ECONOMIC CONDITIONS, THAT PATIENTS FACE IN TERMS OF DISTANCE TO CLINICAL SUPPORT. SO WHY IS THIS AN ISSUE? HEALTH OUTCOMES AS WE KNOW ARE DIRECTLY IMPACTED BY ACCESS TO CARE INCLUDING INDIVIDUALS WITH SICKLE CELL DISEASE. WHEN CONSIDERING ACCESS THE CARE AND TRANSFUSION MEDICINE, INDIVIDUALS WHO LIVE IN RURAL OR REMOTE OR LIMITED HOSPITAL LOCATIONS, HAVE DECREASE ACCESS TO PATIENT AND EMERGENCY TRANSFUSIONS SUCH AS OBSTETRICAL, EMERGENCY TRANSFUSIONS AND TRANSFUSIONS TO SUPPORT CHRONIC ILLNESS. IT IS IMPORTANT TO LOWER THESE ACCESS BARRIERS FOR TRANSFUSION THERAPY AS THIS COULD BE THE DIFFERENCE BETWEEN LIFE AND DEATH FOR POPULATIONS. PATIENTS MUST RECEIVE APPROPRIATE CARE WHEN NECESSARY, FOR EXAMPLE, ADEQUATE TRANSFUSION PHENOTYPICALLY RED BLOOD CELLS AN OUTPATIENT RED CELL EXCHANGESES END IT DAD AND AS NEEDED. -- EXCHANGES AS NEEDED. WHAT IS THE PROPOSED APPROACH? RESEARCH FOCUSED ON COMPARISON OF U.S. STATE LEVEL PROGRAMS TO TREAT FOR TREATMENT OF SICKLE CELL DISEASE AND OTHER HEMOGLOBINOPATHIES AND COSTS REIMBURSEMENT, MORBIDITY AND MORAL. WHAT ARE THE -- MORTALITY. WHAT ARE THE BARRIERS IN? PROPOSED STUDIES IDEAS WOULD BE FEASIBLE THOUGH DEFINITELY REQUIRE USING PUBLIC DATABASES IN CONJUNCTION WITH COST OF COLLECTION NEEDED TO FILL THE GAPS. NEXT SLIDE. DISCUSSION QUESTIONS, MEDICAID EXPANSION MAYBE PART OF THE EQUATION INCREASING ACCESS TO HEALTHCARE IN URBAN AREAS AND RURAL AREAS. WHAT ARE THE PROS AN CONS TO THIS EXPANSION? OVER THE LAST SEVEN OR EIGHT YEARS, BECAME PART OF THE LARGER CONVERSATION WHEN THE AFFORDSABLE CARE ACT EUPHEMISTICALLY KNOWN AS THE OBAMA CARE I GUESS, MEDICAID EXPANSION BECAME A HUGE ISSUE WE ARE STILL TALKING NOW BECAUSE SOME STATES HAVE NOT EXPANDED MEDICARE. THEN THE NEXT DISCUSSION QUESTION IS, CAN NON-PHYSICIAN HEALTHCARE PROVIDERS FILL THE PHYSICIAN GAP. PRIORITY 3 IS ACCESS TO DONATE. WHAT ARE EFFECTIVE STRATEGIES FOR OVERCOMING BARRIERS TO BLOOD DONATION EXPERIENCED BY MINORITY POPULATIONS? DESCRIPTION OF THE PROBLEM IS THAT A DECLINING BLOOD DONOR POPULATION EXACERBATES THE DISPARITIES OBSERVED IN THE UNDERREPRESENTATION OF MINORITY DOE NO, SIR. SO WHILE STUDIES HAVE SOUGHT TO UNDERSTAND THE MOTIVATIONS BEHIND NON-DONOR BEHAVIOR, FEWER STUDIES FOCUS ON THE BARRIERS TO DONATION. ONE OF THE THINGS THAT IS COMMONLY SEEN IN THE LITERATURE AROUND LACK OF INVOLVEMENT OF COMMUNITIES OF COLOR AND DIVERSE COMMUNITIES BLOOD DONATION, THE BLAME IS USUALLY PUT ON THE COMMUNITY. SO THAT IS PART OF THE LITERATURE, PART OF WHY PEOPLE DON'T DONATE BLOOD IS THEY HAVE NEVER BEEN ASKED IN WAY CONSISTENT WITH THEIR CULTURE OR WITH THE WAY THEY FEEL LIKE THEY NEED TO BE ASKED SO WE NEED TO REALLY TAKE A LOOK AT THAT. MINORITIES ARE UNDER-REPRESENTED, IN THE DONOR POPULATION, DUE IN PART O TO EDUCATIONAL BARRIERS, LACK OF ACCESS TO BLOOD DRIVES PHYSIOLOGIC BARRIERS AN LACK OF ENGAGEMENT DUE TO PERCEPTIONS OF CULTURAL RELEVANCE. SO WHY AN ISSUE IN THE DONOR CRITERIA CREATE A BARRIER DUE TO PHYSIOLOGICAL CHARACTERISTICS INCLUDING LOWER HEMOGLOBIN LEVELS AND HYPERTENSION. IN TERMS OF COMMUNITIES OF COLOR, HYPERTENSION CERTAINLY IS AT GREATER HIGH RISK OF HYPERTENSION AN SPECIFICALLY IN TERMS OF AFRICAN AMERICANS, OUR HEMOGLOBIN LEVELS AREN'T ON THE NORMAL LOWER END OF THE HEMOGLOBIN FRAMEWORK. ONE OF THE OTHER ISSUES THAT CERTAINLY HAS TO BE ADDRESSED IS THAT LOOK ACT THE REFERENCE RANGES, IN GENERAL REFERENCE RANGES WE HAVE FOR I WOULD SAY MOST TESTS, PARAMETERS IS BASED ON A MONOLITHIC WHITE POPULATION, SO TO BE ABLE TO RECTIFY THAT WE NEED TO REDO THOSE RANKS TO INCLUDE ALL POPULATIONS AND NORMALIZE THE PHYSIOLOGIC -- PHYSIOLOGY OF ALL POPULATIONS. SO INDIVIDUALS WITHIN THIS COMMUNITY ARE MORE LIKELY TO HAVE RARE BLOOD TYPES OR BE -- HAVE RARE BLOOD GROUPS AS WELL, IN RARE BLOOD GROUPS AS WELL WHICH ARE DESIRED AND HELPFUL TO CLINICAL SUPPORT OF COMMUNITY MEMBERS AS PATIENTS WHO NEEDS BLOOD TRANSFUSION. SO WHAT ARE THE PROPOSED APPROACHES? A SYSTEMIC APPROACH TO UNDERSTANDING AND MITIGATING EDUCATIONAL, CULTURAL, PHYSIOLOGICAL AND ACCESS RELATED BARRIERS TO DONATION CAN BE ADDRESSED IN SINGLE OR MORE -- MULTI-CENTER FORMAT. IN PARTNERSHIP WITH BLOOD CENTERS ALSO IN PARTNERSHIP WITH ORGANIZATIONS, FOCUS ON COMMUNITY OF INDIVIDUALS, THE BROAD COMMUNITY, MULTI-ETHNIC COMMUNITY OF INDIVIDUALS WITH HIGHER RATES OF SICKLE CELL DISEASE AS WELL AS OTHER HEMOGLOBINOPATHIES WE LOOK AT TO THE CDC, SICKLE CELL DISEASE ASSOCIATION OF AMERICA SO WITH OUR COMBINED EFFORTS AND ACTIVITIES, CAN BE DESIGNED TO IMPROVE EDUCATION, COMMUNICATION, PERCEIVED CULTURAL RELEVANCE AND ACCESS ISSUES COULD BE DEVELOPED TO DEEPEN ENGAGEMENT WITHIN THESE COMMUNITIES AS WELL AS HAVE A CONSISTENT LITERATURE THAT CAN BE USED BY ANYONE TO INTERFACE AND INTERACT WITH THESE DIVERSE COMMUNITIES. PRE AND POST INTERVENTION METRICS INCLUDES THE NUMBER OF PRESENTING NEW OR FIRST TIME DONORS, THE RETURN RATE WITHIN ONE YEAR OF SUCCESSFUL DONORS, THE NUMBER OF SPONSORS WITHIN THE COMMUNITY, AND LOOKING AT THE RETURN RATE OF DEFERRED DONORS. IN TERMS OF NEW SPONSORS, BECAUSE BLOOD COLLECTION ORGANIZATIONS RARELY HAVE INTERNALLY WE ARE ALL CERTAINLY GETTING BETTER. HAVE STAFF THAT REFLECT COMMUNITIES THAT WE ARE TRYING TO INTERFACE WITH, OUR PARTNERS BECOME IMPORTANT BECAUSE OUR PARTNERS ARE THE ONES THAT BRING US ALONG WITH THEM INTO THE COMMUNITY. PHYSIOLOGICAL BARRIERS APPLY MOST STRONGLY AGAIN TO AFRICAN AMERICAN DONORS ADDRESSING WHETHER THE MINIMUM HEMOGLOBIN CUTS OFFS ARE APPROPRIATE, FOR POPULATION WHOSE AVERAGE LEVELS AND DISTRIBUTIONS ARE CLEARLY DISTINCT FROM AND LOWER THAN POPULATIONS NOT OF AFRICAN ANCESTRY. OPERATIONAL METRICS INCLUDE DEFERRAL RATES AND RECOVERY OF HEMOGLOBIN AND FERRITIN BETWEEN DONATION VISITS. SO WHAT IS THE FEASIBILITY BARRIERS? STUDIES TO ADDRESS THE FOREGOING BARRIERS TO DONATION CAN BE CONDUCTED CERTAINLY WITHIN THE NEXT THREE TO TEN YEAR TIME FRAME, THOUGH STUDY OF PHYSIOLOGIC BARRIERS TO DONATION WOULD BE OPTIMALLY STUDIED FROM THE OTHER IDENTIFY BARRIERS. THESE STUDIES INFORM WHETHER DONOR CRITERIA BENEFIT FOR MODIFICATIONS. ONE GREAT THING THAT HAPPENED THIS YEAR IN MAY OF 2022, DRAFT GUIDANCE WAS ISSUED BY THE FDA TO THE INDUSTRY, TO LOOK AT BLOOD PRESSURE AND PULSE ELIGIBILITY REQUIREMENTS AND GIVE BLOOD COLLECTION RELATED TO ASSESSMENT OF THESE PARAMETERS. DISCUSSION QUESTIONS WILL RISK-BASED ELIGIBILITY QUESTIONS UP CREASE ACCESS TO DONATION. AND THE OPERATING MARGINS FOR BLOOD CENTERS, IS SMALL. HOW DOES INDUSTRY FUND NECESSARY RESEARCH. SO PRIORITY 4, ADVERSE EVANS. WHAT ARE EFFECTIVE MEASURES TO LOWER THE RATE OF ADVERSE EVENTS FROM PRODUCT TRANSFUSION, BLOOD PRODUCT TRANSFUSION AS WELL AS PREVENT FURTHER DEVELOPMENT OF ADVERSE EVANS IN PATIENTS OF MINORITY DIVERSE BACKGROUNDS. ONE OF THE THINGS WE HAVE SEEN WITH THE 2020 CENSUS IS THAT OUR POPULATIONS BECOMING MORE DIVERSE THAN EVER. THE POPULATION, SEGMENT OF POPULATION THAT HAD HIGHEST PERCENTAGE GROWTH WERE THOSE INDIVIDUALS THAT SELF-IDENTIFIED AS MIXED RACE. SO WE CERTAINLY KNOW THAT WE HAVE TO PAY ATTENTION TO THIS. IN TERMS OF DIVERSE BACKGROUNDS. THE DESCRIPTION OF PROBLEM IS PATIENTS FROM DIVERSE BACKGROUNDS EXPERIENCE HIGHER RATE OF TRANSFUSION RELATED ADVERSE EVENTS, IN PART TO GENETIC DIFFERENCES AND RED CELLS PLATELET AND HLA ANTIGENS ADVERSE EVENTS INCLUDES ALLO IMMUNIZATION, DTHTR, AND CELL ENGRAPHMENT WHICH LED TO SIGNIFICANT MORTALITY AND MORBIDITY AND MAY PRECLUDE LIFE SAVING INTERVENTIONS. SEW WHY IS THIS AN ISSUE? PATIENTS OF AFRICAN DESCENT LIVING MANY THE UNITED STATES HAVE HIGHER RATE OF RED CELL ALLO SENTENCETYIZATION TRANSFUSED FROM A DONOR POPULATION PRIMARILY CAUCASIAN DESCENT. PATIENTS WITH SICKLE CELL DISEASE ARE DISPROPORTIONATELY AFFECTED BY ALLO IMMUNIZATION AND DHCRs, THOUGH LESS WELL DOCUMENTED THIS SIMILARLY AFFECTS HISPANIC POPULATIONS. ALLO IMMUNIZATION AND DTHRs ARE FUTURE SAFE BLOOD TRANSFUSIONS PROPHYLACTIC RED CELL ANTIGEN IS RECOMMENDED TO REDUCE RISK BUT GENETIC MATCHING MAYBE REQUIRED TO MITIGATE THE RISK SUBSTANTIALLY. ALLO SENSITIZATION MAYBE PREVENTED WHEN HIGHER LEVELS OF MATCH BLOOD REQUIRES FURTHER STUDY. WE KNOW THAT THERE ARE LOTS OF APPROACHES TO THIS ALLO SENSITIZATION ISSUE, SOME CLINICIANS, PHENOTYPE THE PATIENT RIGHT UP FRONT BEFORE FIRST TRANSFUSION IF POSSIBLE. THEN THE OTHER APPROACHES, WAIT AND SEE IF THIS PATIENT BECOMES ALLO IMMUNIZED AND WE WILL DEAL WITH IT AFTER THE FACT. SO STRATEGIES TO MANAGE PATIENTS ARE NOT WELL STUDIED. SO WHAT IS THE PROPOSED APPROACH? FIRST PREVENTION. STUDY PROSPECTIVE MATCHING FOR PATIENTS RECEIVING CHRONIC TRANSFUSION USING ADVANCE TECHNOLOGY AN MATCHING ALGORITHMS. DIVERSE ADD MIXED BACKGROUNDS, THAT POPULATION GROWING, MORE PRECISE MATCHING FURTHER REDUCE RISK OF ALLO ANTIBODY FORMATI FORMATION. USEF GENOMICS IN MEDICINE EXPANDS AND EVER EXPANDING AREA, FOR TRANTAS FUSION MEDICINE RED CELL PLATELETS AND HLA GENOTYPING PROVIDES AN AL TERM TEAR GNAT OR HL -- ALTERNATE OR HL ASSAY TO IMPROVE MATCHING OF DONORS AND RECIPIENTS. IN TERMS OF OUTCOMES, MEASURE ALLO IMMUNIZATION AND DHTR RATES, TRANSFUSION DELAYS DUE TO DIFFICULTY IDENTIFYING COMPATIBLE BLOOD AND WHETHER HLA IMMUNIZATION IMPACTS THE ELIGIBILITY FOR CURATIVE STEM CELL TRANSPLANT AND GENE THERAPY. FURTHER PREVENTION, FOR THOSE ALLO IMMUNIZED HIGH RISK OF FURTHER ALLO IMMUNIZATION FEASIBLE STUDIES MANAGEMENT MAY INCLUDE INTENSIFIED MATCHING, PROPHYLACTIC SUPPRESSION FROM FUTURE TRANSFUSION AND USE OF ANTI-COMPLIMENT OR OTHER AGENT TO HALT HEMOLYSIS DURING DHTR. SO IN TERMS OF FEASIBILITY AND BARRIERS, SYSTEMIC APPROACH TO STUDY PROPHYLACTIC RH AN EXTENDED RED CELL ANTIGEN MATCHING BY GENOTYPE SICKLE CELL DISEASE WOULD BE FEASIBLE IN THE NEXT TEN YEARS. WITH SINGLE OR MULTI-INSTITUTIONAL STUDY DESIGN TO DEMONSTRATE CLINICAL IMPACT, AS PERFORM PREVIOUSLY IN OTHER PATIENT POPULATION. THIS REQUIRES COLLABORATION BETWEEN TRANSFUSION SERVICES AND BLOOD DONOR CENTERS. NEW SEQUENCING TOOLS ARE CONSTANTLY EMERGING AS STUDIES AT NOVEL METHODS OF RED BLOOD CELL ANTIGEN GENOTYPING ARE FEASIBLE. SO DISCUSSION QUESTIONS. HOW CAN ADDRESSING HEALTH DISPARITIES AND HEALTH INEQUITIES IN UNDER-REPRESENTED RECIPIENT POPULATIONS DECREASE RECIPIENT ADVERSE REACTIONS? AND HOW CAN THE CHANGE IN ADVERSE REACTION RATES BE QUANTIFIED? SO THE FIFTH PRIORITY STRUCTURAL BARRIERS. WHAT ARE THE STRUCTURAL SOCIETAL ELEMENTS THAT IMPACT ACCESS TO TRANSFUSION ME SIN THERAPIES? AND HOW CAN THESE BARRIERS BE OVERCOME TO ACHIEVE EQUITABLE HEALTHCARE? SO IN TERMS OF DESCRIPTION OF THE PROBLEM, ACCESS TO HEALTH INSURANCE, CONSTRAINTS OF HEALTH INSURANCE POLICIES CAN PREVENT ACCESS TO TRANSFUSION MEDICINE CARE THERAPY, THERAPY AND DIAGNOSTICS. FOR INSTANCE THERE IS A HIGHER MATERNAL MORTALITY AMONG AFRICAN AMERICAN WOMEN, HOWEVER, THE ROLE TRANSFUSION MEDICINE PLAYS IS NOT WELL UNDERSTOOD. IN ADDITION, THE IMPACT OF RACIAL CULTURAL LINGUISTIC INCONGRUENCE WEAN PATIENTS AND DONORS AND THE TRANSFUSION MEDICINE WORK FORCE REQUIRES EXAMINATION ALONG WITH THE STUDY OF STRUCTURAL FACTORS THAT SUSTAIN IT. SO WHY IS THIS AN ISSUE? THE LINK BETWEEN HEALTHCARE DISPARITIES, AND STRUCTURAL FACTORS WITHIN INSTITUTIONS, ORGANIZATIONS, PROCESSES IN OUR SOCIETY, IS ESTABLISHED THROUGHOUT THE LITERATURE. MOSTLY IN THE PUBLIC HEALTH LITERATURE BECAUSE THE SCIENTIFIC LITERATURE UNTIL THE LAST TWO OR THREE YEARS SINCE WE HAVE BEEN IN THIS COUNTRY WE HAVE BEEN IN THIS CONVERSATION ABOUT SOCIAL CHANGES AND SOCIAL INJUSTICE AND HEALTH DISPARITIES AND HEALTH INEQUITIES THERE'S A DERTH OF LITERATURE IN THIS SPACE BUT LOOK AT THE LAST TWO YEARS TREMENDOUS AMOUNT OF CONVERSATION AROUND HEALTH DISPARITIES. HEALTH DISPARITIES AMONG RACIALIZED GROUPS HAVE BEEN DOCUMENTED CONSISTENTLY MANY THE U.S. FOR MANY DECADES. REGRETTABLY THERE IS SCARCITY OF LITERATURE ADDRESSING STRUCTURAL BARRIERS INCLUDING STRUCTURAL RACISM WITHIN TRANSFUSION MEDICINE FIELD. DEFINE QUANTIFY THESE STRUCTURAL BARRIERS FOLLOWED BY THE DESIGN AND IMPLEMENTATION OF INTERVENTION STRATEGIES IS IMPERATIVE TO ACHIEVE TRUE HEALTH EQUITY. SO WHAT IS THE PROPOSED APPROACH? MULTI-CENTER AND MULTI-DISCIPLINARY COLLABORATION AS WELL AS PUBLIC PRIVATE PARTNERSHIPS, INCLUDING HEALTH INSURANCE COMPANIES AN GOVERNMENT INSURANCE STAKEHOLDERS WITH COMMUNITY AS VISERY BOARDS ARE ABSOLUTELY IN COVERAGE. OBJECTIVE IDENTIFICATION OF STRUCTURAL BARRIERS, SHOULD BE FOLLOWED CLOSELY BY IMPLEMENTATION OF RESEARCH TO EVALUATE POSSIBLE INTERVENTIONS AND CORRECTED ACTIONS SHOULD BE IMPLEMENTED WITHOUT DELAY. FACTORS THAT MERIT INVESTIGATION INCLUDE CHARACTERIZATION, CHARACTERIZING THE VARIATION AND ACCESS AND QUALITY IN TERMS OF TRANSFUSION CARE BY RACE, ETHNICITY, GENDER IDENTITY, GEOGRAPHIC RESIDENCE, SOCIOECONOMIC STRATA AS WELL AS OTHER DEMOGRAPHIC ATTRIBUTES. IN TERMS OF FEASIBILITY AND BARRIERS, RESEARCH PRIORITIES REPRESENT IMPORTANT WORK THAT BUILDS UPON ITSELF AND CONTINUE TO STRONG CORRECT TESTIFY MEASURES DEMONSTRATED OR ARE FIRMLY IN PLACE. IT CANNOT BE UNDERESTIMATED HOW IMPORTANT COMMUNITY BASED PARTICIPATORY RESEARCH IS, IN TERMS OF USEFUL TOOL, THAT IS BEING USED TO IDENTIFY SOCIAL, STRUCTURAL AND ENVIRONMENTAL BARRIERS AND IDENTIFY SOLUTIONS. CHANGES TO HEALTH POLICY REIMBURSEMENT TO ENSURE HEALTH EQUITY AND TRANSFUSION MEDICINE WILL BE NECESSARY. SO THE DISCUSSION QUESTIONS ARE ACKNOWLEDGING STRUCTURAL NATURE OF RACISM AND BIAS IN HEALTHCARE IS THE INITIAL STEP IN DETERMINING SOLUTIONS. HOW IS THIS ACCOMPLISHED ON NATIONAL BASIS? WHERE WOULD ACCOUNTABILITY FOR EXECUTION REST? HEALTHCARE IS A FACET OF SOCIAL DETERMINANTS OF HEALTH WHICH AFFECT HOW INDIVIDUALS AN COMMUNITIES ACHIEVE FULL HEALTH AND WELL BEING. ARE COMMUNITY BASED MODELS THAT CAN BE SCALED TO BE USED IN VARIOUS COMMUNITIES. FINAL SLIDE RESTATING OUR PRIORITIES. AND AGAIN NOT ANY PARTICULAR ORDER, HOW CAN DIVERSITY RESEARCH PARTICIPANTS BE INCREASED FOR BOTH BLOOD DONOR STUDIES AND CLINICAL STUDIES. ACCESS TO APPROPRIATE TRANSFUSION CAN BE LIMITED BY CULTURAL NORMS, FINANCIAL AND GEOGRAPHICAL BARRIERS HOW CAN BARRIERS BE OVERCOME. WHAT ARE THE EFFECTIVE STRATEGIES FOR OVERCOMING BARRIERS TO BLOOD DONATION EXPERIENCED BY MINORITY POPULATIONS. WHAT ARE EFFECTIVE MEASURES TO LOWER THE RATE OF ADVERSE EVENTS FROM BLOOD PRODUCT TRANSFUSION, AS WELL AS PREVENTS FURTHER DEVELOPMENT OF ADVERSE EVENTS IN PATIENTS WITH MINORITY DIVERSE BACKGROUNDS AND WHAT ARE THE STRUCTURAL SOCIETAL ELEMENTS THAT IMPACT ACCESS TO TRANSFUSION MEDICINE THERAPY AND HOW BARRIERS OVERCOME TO ACHIEVE EQUITABLE HEALTHCARE. SO THANK YOU SO MUCH FOR YOUR ATTENTION. CONTINUE TO DROP YOUR THOUGHTS AND QUESTIONS IN TO THE CHAT. AGAIN, THANK YOU FOR OUR ENTIRE GROUP AND CO-CHAIR DR. MEGHAN DELANEY. >> THANK YOU VERY MUCH, YVETTE. WONDERFUL PRESENTATION. WE COMPLETED THE PRESENTATIONS OF THE WORKING GROUP CO-CHAIRS FOR THE GENERAL SESSION AND WE ARE IN OUR LUNCH BREAK NOW. PLEASE RETURN, HALF AN HOUR LUNCH BREAK. WE WILL RETURN, HEAR SAYS 12:30, BUT A LITTLE EARLIER IF YOU LIKE DIRECTION IN FINDING THE BREAK OUT SESSION LINK ON THE ZOOM CHAT BAR. THANK YOU. >>I WANT TO WELCOME EVERYBODY BACK FROM THE BREAK. THE NEXT PAR OF OUR AGENDA IS RECAP OF THE BREAK OUT SESSIONS THAT THE CO-CHAIRS HAVE THE UNENVIABLE -- >> IF I MAY INTERRUPT. I THINK WE ARE STILL WAITING FOR SOME PEOPLE AT THE BREAK OUTS. JUST 20 SECONDS. >> WELCOME BACK, EVERYONE. LOOKS LIKE MAJORITY OF HAD A CHANCE TO REJOIN THE SESSION. NEXT PART OF OUR AGENDA IS FOR EACH OF THE WORKING GROUP CO-CHAIRS TO SUMMARIZE IN RAPID FASHION DISCUSSION OF THE BREAK OUT SESSION OVER THE LAST HOUR. FIRST TO DO SO IS ELDAD AND ANGELO. >> WE HAVE A LOT OF TIME TO PREPARE FOR THIS BUT WE WILL DO THE BEST WE CAN AS WE HAD LIVELY DISCUSSION FOR AN HOUR WITH A WONDERFUL GROUP OF PEOPLE WHO SHARED THEIR THOUGHTS REGARDING PRIORITIES. SO I FEEL LIKE WE SPENT A LOT OF TIME DISCUSSING THE STORAGE LESION AND THE CLINICAL TRIALS SURROUNDING THE CLINICAL IMPACT OF THE STORAGE LESION. WHAT I GOT FROM THE -- WHAT WE THINK WE GOT FROM THE DISCUSSION IS THAT CLEARLY MORE RESEARCH IS NEEDED AND THAT MORE SYSTEMATIC APPROACH GOING FROM THE BENCH BACK O THE -- FROM THE BENCH TO BEDSIDE AND BACK AGAIN IS STILL NEEDED. WE ARE PROBABLY NOT GOING TO REPEAT THE CLINICAL TRIALS THAT HAVE ALREADY DONE SURROUNDING THE AGE OF BLOOD BUT WE STILL NEED TO FIND, LOOK FOR ADDITIONAL RECIPIENT POPULATIONS OR ADDITIONAL BIOMARKERS CAPTURED METABOLIC AGE OF THE OPPOSED TO THE CHRONOLOGICAL AGE USED TO RANDOMIZE ON AND SO THERE'S STILL ADDITIONAL WORK FROM PRE-CLINICAL STAGE THAT NEEDS TO GET DONE TO THEN FUTURE TAKE IT TO THE THE CLINICAL TRIALS. THERE WAS SOME MENTION MORE RIGOROUS VALIDATION OF BIOMARKERS NEEDS TO BE DONE AND WE HEARD THERE ARE SOME AVAILABLE BIOMARKERS AND TOOLS THAT EXIST THAT WE MIGHT BE UNDERUTILIZING AND THOSE COULD BE UTILIZED MORE SUCH AS NEERS AND OTHER PUBLIC THINGS. WHAT ELSE? THERE WAS ALSO SOME TALK ABOUT AND THIS MAYBE OVERLAPS WITH ONE OF THE SESSIONS FROM YESTERDAY BUT DIFFERENT CLINICAL TRIAL DESIGNS THAT MAY ALLOW US TO LOOK AT BIOMARKERS AND IMPACT SUCH AS ADAPTIVE TRIAL DESIGNS AND THINGS LIKE THAT. ANOTHER AREA IS ADDITIONAL RECIPIENT FACTORS THAT WE SHOULD TAKE INTO ACCOUNT SUCH AS RECIPIENT ANEMIA OR RECIPIENT INFLAMMATION THAT MAY IMPACT OUTCOMES OF PLATELET OR RED CELL TRANSFUGS AND THOSE SHOULD BE INCORPORATED TO PRIORITIES SO WE ADHERE THAT. CERTAINLY THE INTERACTION WITH VARIOUS THINGS WE DO IN BLOOD BANK OR CENTER LIKE IRRADIATION AND THINGS LIKE THAT AND IMPACT OF THOSE MODIFICATIONS AND HOW THEY IMPACT RECIPIENT. WE ALSO HAD A LITTLE DISCUSSION AROUND ARE THERE -- NOW -- AT LEAST FOR COLD STORED PLATELETS, WE KNOW MECHANISM OF CLEARANCE AND THERE ARE DRUGS AVAILABLE THAT CAN BLOCK THOSE SHOULD WE DO MORE STUDIES TO LOOK AT THERAPEUTIC INTERVENTIONS THAT COULD PREVENT CLEARANCE OF PLATELETS OR IF WE UNDERSTOOD THE MECHANISM OF RED CELL CLEARANCE BETTER CAN WE DESIGN DRUGS THAT WOULD PREVENT THAT AS WELL. SO WE HEARD THAT AS WELL. AND TRY TO INCORPORATE THAT INTO PRIORITIES. FINAL THING I HAD IN MY NOTES WAS RELATING TO LONGER TERM STUDIESs ESPECIALLY NEONATES AND TRANSFUSIONS, INTERUTERINE TRANSFUGS DURING PREGNANCY AND WE DON'T KNOW WHAT THE LONGER TERM IMMUNOLOGIC OR OTHER CLINICAL OUTCOMES ARE OF THESE TRANSFUSIONS ESPECIALLY IN YOUNG AND CLEARLY YOU NEED LONGER -- AS WE HAD IN PRIORITY WE NEED LONGER TERM STUDIES TO FOLLOW-UP ADVERSE CONSEQUENCES ESPECIALLY IN THE YOUNGER POPULATIONS SO THERE WAS GOOD DISCUSSION AROUND THAT. I KNOW WE WERE SUPPOSED TO -- WE HAD UP TO 20 MINUTES BUT TOLD WE DIDN'T HAVE TO USE THE FULL 20 MINUTES BUT ANGELO IF YOU HAD ADDITIONAL THINGS TO ADD. >> TWO ADDITIONAL POINTS, AS SOMEBODY WITH NO TIME PRETTY MUCMUCH. THE ONLY TWO OTHER THIS I HAVE ARE COMMENTS THAT CAME DURING THE PRESENTATION THAT PERTAIN TO OPPORTUNITY TO SELECT DONORS BASED ON FOR EXAMPLE KNOWING WHETHER CASE DONORS PARTICULARLY IF (INAUDIBLE) WHETHER WE KNOW THEY ARE GOING TO STORE POORLY, WHETHER WE CAN IDENTIFY PERSONALIZE THE APPROACH AND DONORS BE COLD STORE, ROOM TEMPERATURE AND USE PLATELETS DEPENDING ON ACTIVATION PROFILES FOR SPECIFIC INDICATIONS. THIS COMMENT WITHIN THE FRAMEWORK OF POTENTIAL APPLICATION OF MORE LIKE PERMIZED APPROACHES -- PERSONALIZED APPROACHES THAT TOOK INTO ACCOUNT THE PHENOTYPES AND THE NEEDS. THAT'S THE AMOUNT I HAVE IN TERMS OF NOTES, AND I SEE THERE IS A HAN HAND RAISED >> STEVE I DON'T KNOW IF YOU MEANT TO HAVE YOUR HAND RAISED. >> I WANT TO ASK A QUESTION TO ELDAD. IS YOUR GROUP ADVOCATING NEW CLINICAL TRIALS ON RED CELL TRANTAS FUSION THRESHOLDS NOW? OR ARE YOU SAYING WE NEED BETTER TOOLS TO DETERMINE THE METABOLIC AGE OF RED CELLS AND ONCE WE DO THAT THEN MAYBE CLINICAL TRIALS COULD FOLLOW. I WASN'T SURE WHAT THE CONCLUSION WAS. >> SO I'M NOT SURE WE ARE ADVOCATING EITHER. WE ARE ADVOCATING FOR MORE RESEARCH RELATING TO BIOMARKERS THAT MIGHT LEAD TO FUTURE CLINICAL TRIALS. YOU ARE ASKING REGARDING THRESHOLDS OR AGE OF BLOOD? OUR DISCUSSION WAS RELATING TO THE AGE OF BLOOD NOT SO MUCH THE THRESHOLD: TO THE EXTENT THERE IS A RECIPIENT POPULATION THAT HAS NOT BEEN STUDIED, THERE IS ENOUGH PRELIMINARY DATA TO SUPPORT A CLINICAL TRIAL THEN WE WOULD ADVOCATE FOR THERE TO BE FUNDING OR FOR THERE NOT FUNDING BUT THERE TO BE A CLINICAL TRIAL PROPOSED. >> THIS IS WHERE I'M COR ARE I FOR PERSEVERATING. THIS IS WHERE I'M CONFUSED. IN THE ABSENCE OF BETTER BIOMARKERS WHERE THE NOT BOLLIC AGE OF RED CELLS YOU ARE STILL ADVOCATING FOR CLINICAL STUDY IN SUBGROUP OF PATIENTS WHO HAVE NOT YET BEEN STUDIED? WHO MAY ACTUALLY -- IF YOU DID THAT WITHOUT THE METABOLIC MARKER THEN YOU WOULD JUST BE EVALUATING STORAGE AGE VERSUS OUTCOME IN A GROUP THAT WAS IN A SUBSET OF PATIENTS THAT YOU THOUGHT HAD NOT BEEN STUDIED ADEQUATELY? >> I THINK WE NEED TO THINK ABOUT DIFFERENT TYPE OF CLINICAL DESIGNS THAN I HAVE DONE IN THE PAST. I THINK THAT -- THERE ARE CERTAINLY CERTAIN PATIENT POPULATIONS THAT HAVE NOT BEEN STUDIED, AGAIN ONE EXAMPLE WE KEEP COMING BACK TO ARE CHRONICALLY TRANSFUSED PATIENTS WHERE CLEARLY THE SURVIVAL OF THE RED CELLS HAS GREATER IMPACT BUT OUTCOME THERE IS NOT MORTALITY, THEY ARE CHRONICALLY TRANSFUSED SO DIFFERENT OUTCOMES YOU CAN LOOK AT. AND I MOW WE ARE STUDYING THAT THROUGH OBSERVATION, THERE MAYBE OTHER CLINICAL TRIAL DESIGNS THAT ONE COULD APPROACH TO DO INTERVENTIONS TO LOOK IN DIFFERENT POPULATIONS WHETHER THAT MIGHT IMPROVE DIFFERENT OUTCOMES THAN THOSE THAT HAVE BEEN LOOKED AT SO NOT NECESSARILY PROPOSING THAT WE NEED BIOMARKERS, IT WOULD BE GREAT IF -- IF THERE WERE BIOMARKERS IF SOMEONE HAD ONE THAT THERE WAS SUFFICIENT PRE-CLINICAL DATA TO SUPPORT A CLINICAL TRIAL THEN SURE LET US PROPOSE ONE BUT THERE MAYBE OTHER CLINICAL TRIAL DESIGNS SOMEONE MIGHT PROPOSE. >> THANKS FOR THE CLARIFICATION >> OTHER QUESTIONS OR COMMENTS? >> I HAVE ONE QUICK COMMENT WHICH WAS I THINK IT WAS A VERY HELPFUL DISCUSSION IN THAT LAST SESSION ABILITY STUFF THAT WAS SUMMARIZED BUT WHAT WE DIDN'T GET TO WAS I HOPE WILL BE INCLUDED IN SUMMARY STATEMENT, I THINK SUMMARIZED BY THE WORKING GROUP, ISSUES SURROUNDING ALLOIZATION, THE NEED TO STUDY UNDERSTANDING, EVIDENCE NECESSARY SENSE, ALL THOSE DIDN'T COME UP BECAUSE OF ROBUST DISCUSSION AROUND OTHER SUBJECTS BUT I WOULD ENCOURAGE ELDAD AND ANGELO TO INCLUDE THOSE IN YOUR GENERAL DISCUSSION AS THIS GOES FORWARD TO THE NIH. >> OF COURSE. >> THESE ARE DRAFT PRIORITIES AND STILL TIME BEFORE FINALIZATION AND THERE COULD BE OPPORTUNITIES TO SHARE INPUT AND THEY WILL TALK ABOUT THAT LATER >> OTHER QUESTIONS OR COMMENTS? THANK YOU ELDAD AND ANGELA. I CERTAINLY CHALLENGE TRYING TO DIGEST WHAT COMMENTS AND CONVERSATION OF THE BREAK OUT AND BEING FIRST STEP. THANK YOU FOR THAT. NEXT RUCHIKA AND JANSENISM >> I LIKE TO SHARE MY SCREEN. IF THAT'S OKAY. SO WE HAD A LIVELY DISCUSSION, OUR RECORD SUBGROUP, JAN SON AND I WERE TRYING TO COMPILE ON OUR INFORMATION FEEDBACK INTO SLIDES AN COMMENTS, SO HERE WHAT WE HAVE IS FEEDBACK RECEIVED BY PARTICIPANTS. SO GOING BY THE PRIORITY, FOR THE INFORMATION COMMUNICATION TECHNOLOGY AND SOCIAL MEDIA TO UNDERSTAND THE BEHAVIOR OUR KNOWLEDGE POWER OF CLUCK AND ACCESSIBILITY DIVERSE CONCERNS RAISED FOR EXAMPLE IN UNITED STATES WITH DIFFERENT ORGANIZATIONS, AS THE COLLECTORS HOW WOULD LIKE NOTIFICATION SYSTEM BE ABLE TO FAIRLY DIRECT DONOR WITH COMPUTATION AMONG COLLECTORS, THAT'S MISWRITTEN THERE. IS THERE A WAY TO MAKE THE PLATFORM NEUTRAL FOR AN INTERVENTION LIKE THAT. WE ALSO DISCUSS IN RELEVANCE TO ANOTHER QUESTION THAT SOMETHING LIKE THIS IN CANADA, THERE IS ONLY TWO COLLECTORS PRIMARILY, MAY NOT BE A PROBLEM SO BEFORE A TOOL LIKE THIS IS IMPLEMENTED, APPLICATION IN THE UNITED STATES, SOMETHING THAT NEEDS TO BE LOOKED INTO WE DISCUSSED THE ROLE OF EVENTS FOR THE MASS CASUALTY EVENTS, AND BUT THERE ARE CURRENTLY THE INFORMATION LACKS AUTOMATION. FOLLOW-UP ON DOCUMENTING THE EFFECTIVENESS OF INTERVENTION LIKE THIS. CAN BE HARD BECAUSE SOMETIMES THE BLOOD ESTABLISHMENTS DON'T USE IN REAL NAME ON LINE AND THEY MAY BE USE NON-SPECIFIC NAMES SO THAT COULD LEAD TO DOCUMENTING EFFECTIVENESS, NOT AN EASY TASK THERE WAS CONCERN RAIDED FOR SOME OUTCOME LIKE THIS WITH NON-DONORS NOT RESPOND THAT MUCH SO INVERTED RISK OF SYSTEMIC BIAS AS WE ASSESS THESE INTERVENTIONS, WHILE WILL CAN BE BENEFIT OF CAUSATIVE DONATION EXPERIENCE, THE NEGATIVE IMPACT OF -- IT CAN BE MORE NEGATIVE, SOMEONE HAD NEGATIVE DONATION, IN THE BLOOD CENTER REALLY HARD. CAN IT ADVERSELY AFFECT COLLECTIONS LIKE NEGATIVE REVIEW POSTED. IF WE CAN USE THIS IN THE FUTURE TO INCORPORATE MORE SYSTEMATIC FEEDBACK WITH BLOOD CENTER OPERATIONS AND SOME BLOOD DONORS AND COLLECTION CENTERS COMMENTED THEY ARE ALREADY TRACKING THE SOCIAL MEDIA COMMENTARY FAIRLY CLOSELY. SOFT THAT IS FIRST, PRIORITY. FOR OUR SECOND PRIORITY ABOUT MULTI-DIMENSIONAL DATABASES AND DATA VISUALIZATION, WE HAD VERY HEATED INTENSE DISCUSSION. SO SOME IMPORTANT CONCERNS ABOUT THE DATA COLLECTION MODEL IS IT SUFFICIENT FOR RELATED RESEARCH AND GIVE SUFFICIENT DETAIL. SO CERTAINLY WE ACKNOWLEDGE AS WE ARE DOING MAPPING FROM EHR TO OMOP STANDARDS THERE'S LOSS OF SPECIFICITY AND NOT EXACT MATCHES ARE FOUND SO ONE DOES HAVE TO SELECT THE BEST AVAILABLE SO THERE ARE TRADE OFFS. HOWEVER, JUST WE GOT SOME RECENT EXPERIENCES HERE FROM ADAPTIVE RED 4P AND OMOP IS EVOLVING AND OVER THE YEARS THE REACH HAS GROWN. SO AT LEAST FROM CURRENT UNDERSTANDING FOR APPLICATION TO MEDICINE THE PRODUCT AND POSSIBLE SIDE OF RECIPIENT COVERAGE IT LOOKS BETTERMENT THE QUALITY OF DATA IMPROVED BUT THE DONOR SIDE OF THE DATABASE MODEL IS REALLY LEARNING AND THE LEARNING IS GOING WITH ADOPTING DONOR AS PATIENT AND USING THE SAME MODEL. WE HAVE DISCUSSIONS ABOUT INCLUDING DONORS AND COULD WE HAVE BETTER DONOR DATA INCORPORATED. THIS WAS SHARED THAT FDA BEST DEVELOP OMOP -- WHICH ACTS AS THE ISPP CORDS TO IDENTIFY TRANTAS FUSED COMPONENT. SO IT IS STILL REQUIRES SOME REGIONAL LEVEL WORK, SIMILAR BUT IT IS A POSSIBILITY. ONE IMPORTANT CONCERN AND FEEDBACK THAT CAME WAS FOR THE -- ANY WAY TO MAINTAIN DATA AND ITS APPLICABILITY WAS THE REAL TIME DATA AGGREGATION BECAUSE DATA TENDS TO LAG BY YEARS AND MONTHS. SO WE HAVE SOME -- THAT SOMETHING AS WE WORK ON SEVERAL DATABASES CURRENTLY, WE DISCUSS NOVEL STRATEGIES LIKE NLP NATURAL LANGUAGE PROCESSING FOR POPULATING ELEMENTS FROM THE HIV DATA. A LOT OF THIS IS EXPERIMENTAL BUT THERE IS SOME RESEARCH UPCOMING THAT SHOULD BE PRESENT IN THE NEAR FUTURE LOOKING HOW THIS IS IMPLEMENTED FOR ANY DATA FIDELITY OF DATA, IT REALLY DOES ALWAYS COME DOWN TO HOW TRUE THE DATA, ANYTHING DERIVED INDEPENDENT OF DATA, SO WE DISCUSS TIME STAMPS WHEN TRANSFUSION HAPPEN WHEN WAS PRODUCT ISSUED WAS IT ISSUED OR ISSUED FROM THE BLOOD BANK, NOT VALIDATION AND ARE WE PAYING ATTENTION TO THOSE DETAILS AS WE DO DATABASE LEVEL RESEARCH. WE ALSO SPOKE ABOUT COLLABORATION WITH THE HHS OFFICE OF NATIONAL COORDINATOR TO GET BIOLOGICALLY DERIVED PRODUCTS INTO THE U.S. CORE DATA FOR INTEROPERABILITY. THAT CAN BE REALLY A LOT OF COMMUNICATION BETWEEN BLOOD BANK SOFTWARE AND EHR. SO SOME USEFUL DISCUSSIONS HERE BETWEEN WOULD LIKE TO TAKE BACK TO OUR WORKING GROUP. FOR THE DATA DRIVEN APPROACHES ABOUT THE ECONOMIC EVALUATIONS, THIS POINT CAME UP THAT RECENTLY FOCUS IS ON INFECTIOUS DISEASE SCREENING AND EFFICIENCY AND THE EFFICACY AND THAT IS VERY IMPORTANT. HOWEVER DATA FROM THE HOSPITALS RECIPIENTS AND DOWNSTREAM CLINICAL IMPACT IS LIMITED. SO WE DID DISCUSS IT EARLIER IN PRESENTATION HOWEVER NON-INFECTIOUS OUTCOMES AND ADVERSE EVENTS NEED TO BE FOCUSED ON AND THIS IS A CHALLENGE. WE DISCUSS SCENARIOS WHERE ECONOMIC EVALUATIONS WOULD BE HELPFUL FOR EXAMPLE USE OF MACHINE COMPATIBLE PLATELETS AND DEVELOPMENT OF UNIFIED DATABASE TO UNDERSTAND SOME RESOURCE INTENSE PRACTICES LIKE SIMPLY DONOR MATCH COMPATIBLE DATA HOW WE DO THAT FOR A SELECT POPULATION. MOVING ON FOR OUR MACHINE LEARNING AND ARTIFICIAL INTELLIGENCE SEVERAL FEEDBACK AND COMMENTS, BASICALLY WE HAVE SOME SEVERAL STUDIES COMING BUT HOW CLINICAL TOOLS APPLICABLE. WE NEED ONGOING DEMONSTRATION OF GENERALIZABILITY SCALABILITY AND ROBUSTNESS SO THESE STUDIES ARE NOT REACHING CLINICAL GRADE APPLICATION LEVEL. WE HAVE TO BE MORE SPECIFIC ABOUT THE USE CASES. WHERE ARE TECHNIQUES APPROPRIATE, HOW ARE WE ADDRESSING THE IMPLEMENTATION GAP. I THINK ONE CONCERN WAS THAT THE PREDICTIVE MODEL BEYOND MODELING STAGE, IMPLEMENTATION STAGES NASCENT STAGE HOW ARE WE MONITORING THAT IS IMPORTANT, KEY METRICS FOR THAT. THE QUESTION OF EQUITY VERSUS EQUALITY, A MODEL THAT IS DERIVED FROM ANOTHER TRAINING DATA SET, IS IT GENERALIZABLE AND DEPLOYABLE IN PATIENT POPULATION WHICH WAS INDEPENDENT OF THAT, THE INTENDED USE POPULATION IS IT THE SAME SO COULD BE MAKING ERRORS IN THE APPLICATION VERY TRAINING DEPLOYMENT, THE APPLICATION CAN BE DEPENDENT ON TRAINING DATA SO MAKING SURE THAT FOR TRAINING DATABASE SETS MULTI-CENTER DATA DIVERSITY IS INCLUDED AS IMPORTANT. THAT TAKES INTO ACCOUNT CURRENT IMPLEMENTATIONS ARE NOT ACCURATE, COULD WE BE CONCERNED ABOUT POTENTIAL HARM ESPECIALLY FOR UNDER-REPRESENTED GROUPS OR WHERE IT RESULTS APPLIED NOT ENOUGH DIVERSITY IN OUR DEVELOPMENT IN THE TRAINING DATABASES. FOR GENOMICS WORKING GROUP INTEGRATING GENOMICS TO CLINICAL TRANSFUSION WORK FLOWS, WE DISCUSSED REGULATORY VALUES INHIBITED ADOPTION OR USING THE GENOTYPING AND INTERESTING PERSPECTIVE FROM SELENA SERVICES FOR EXAMPLE THE DIFFERENCE BETWEEN U.S. AND CANADA IS THAT BECAUSE THERE ARE FOR THE ENTIRE COUNTRY BASICALLY TWO BLOOD COLLECTORS WITHIN THAT ONE BEING MORE PRIMARY IT IS EASIER TO ESTABLISH WORK FLOWS THE INTEROPERABILITY IS EASIER, SHARING INFORMATION STANDARDIZATION WHICH IS GOING TO BE A CHALLENGE FOR REALLY WIDE SCALE GENOMICS IMPLEMENTATION IN US. WE DO NEED TO TAP INTO THE BLOOD DONOR DIVERSITY AS WE TRY TO MAKE GENOMICS WORK SUCCESSFUL AND SO THE PROGRAM HAS ESTABLISHED PROGRAM GENOTYPE FOR DONORS AND PATIENTS IS USED TO PROVIDE COMPATIBLE PRODUCTS FOR PATIENTS WITH ALLO ANTIBODIES. SO THERE'S SOME BACKGROUND ON WHAT PROGRAMS ARE IN PLACE AND HOW CAN WE MAKE IT WIDER MORE ACCESSIBLE DISCUSSED. VERY LIVELY DISCUSSION WE GOT THROUGH PRETTY MUCH ALL OUR PRIORITIES. I WOULD LIKE TO STOP HERE. >> FEW COMMENTS IN THE CHAT FROM AMANDA HESS. AARP LAUNCHING A WEBSITE TO HELP SUPPORT WORK OF PRIORITY NUMBER ONE. THEN FROM DARRELL CORE, THE PROMISE OF AI ML IS EXCITING IN THIS SPACE. AND ECHOING COMMENTS WE RAISED DURING THE BREAK OUT SESSION. >> I REACHED OUT TO AMANDA, PROBABLY AS WE TRY TO FINE TUNE THAT PRIORITY 1, TO DARRELL'S POINT THAT WAS THE OBJECTIVE OF HAVING PRIORITY FOCUS ON IMPLEMENTATION. RATHER THAN JUST RESEARCH INTO USE CASES FOR AI ML. THE REAL CHALLENGE IS IMPLEMENTING A MODEL AFTER IT'S BUILT. THEN CREATING BETTER DATABASES FACILITATES THE FRONT END WHICH IS CLEANING DATA MANIPULATING DATA, DATA ENGINEERING IN GENERAL. SO WE TRIED TO HAVE PRIORITIES THAT FOCUS ON THE FRONT AND BACK END AND NOT JUST AI ML USE CASES. >> AS WE DO OUR FINAL WRITE UP THESE ARE IMPORTANT FEEDBACK TO INCORPORATE. THANK YOU. >> I HAVEN'T ABLE TO JOIN THIS BREAK OUT BUT WONDER IF OFTEN TIMES ONE OF THE CHALLENGES IS WE LIKE TO CREATE MODELS USING STATIC RELATIONAL DATA THAT MIGHT EXIST IN OMOP DATA MODEL BUT REALITY USING THE MODEL UTILIZES IN WORK FLOWS NEEDS TO BE BUILT ON TRANSACTIONAL DATA MODEL THAT LOOKS DIFFERENT FROM OMOP DATA MODEL. HOW DO YOU ADDRESS THE GAP OF CREATING MODELS USING A STATIC RELATIONAL DATA ENVIRONMENT WHEN MODELS HAVE TO BE IMPLEMENTED ON A VERY DIFFERENT ENVIRONMENT AND CHALLENGES ARE AROUND THAT IMPLEMENTATION. >> WE DISCUSSED THAT WHEN IT CAME TO DATABASES. HOW DO WE MOVE FROM THIS STATIC DATABASE AGGREGATION TO REAL TIME DATA AGGREGATION. WHAT YOU ARE TALKING ABOUT AS WELL IS THE FIELDS WE USE THE TRAIN THE MODEL MAY NOT BE ACCESSIBLE FOR REAL TIME. THAT DID NOT COME UP AND WE WILL ADD TO LIST OF COMMENTS AS WELL. >> OTHER QUESTIONS OR COMMENTS FROM WORKING GROUP CHAIRS? THANK YOU VERY MUCH, RUCHIKA AND JANSEN, WONDERFUL JOB. >> THANK YOU. >> GO NOW INTRODUCE YVETTE MEGHAN TO PRESENT SUMMARY OF THEIR BREAK OUT SESSION. >> THANK YOU SO MUCH, NAREG. SHOW YOU COUPLE OF SLIDES THEN WE WILL CONTINUE TO TALK WITH THOSE SLIDES. I WILL START BY SHOWING -- FIRST I -- BEFORE I SAY ANYTHING ELSE I WILL SAY THIS GROUP AND OUR DISCUSSION THAT WE JUST HAD AS WELL AS THE WHOLE PAST YEAR WORKING TOGETHER HAS BEEN A LEARNING EXPERIENCE. EYE OPENING AND ALSO VERY ENGAGING, JUST SO INSPIRING TO HAVE SO MANY WANTING TO COME FORWARD AND TALK ABOUT THESE ISSUES THAT ARE UNFORTUNATELY PART OF THE FABRIC OF OUR SOCIETY THAT WE HAVE TO CALL OUT AND WORK TOGETHER TO IMPROVE HEALTHCARE FOR ALL PEOPLE. SO THE FIVE PRIORITIES THAT WE HAVE HERE, WE FEEL -- I WANT TO CLARIFY, THEY ARE NOT IN ORDER THEY ARE ALL IMPORTANT AND WE HAVE THEM NUMBERED ONE TO FIVE AND WE DON'T THINK -- THEY ARE QUITE BROAD IN GENERAL AND WE LIKE THEM THAT WAY. THOUGH WE HAVE MORE TO ADD ABOUT THEM AS WELL THAT CAME UP ESPECIALLY DURING THE BREAK OUT SESSION. SO SHOW THIS ONE SLIDE TO EMPHASIZE SOME MAJOR THEMES AND THEN I WILL TALK MORE ABOUT SOME OF THE REALLY INTERESTING COMMENTS THAT WERE BROUGHT UP. SO THINKING ABOUT WHY WE WERE CALLED TOGETHER BY THE NIH, SO OUR RESPONSE BACK IS WE FEEL THE FUNDING FROM NIH SPECIFICALLY ALLOCATED TO STRENGTHEN HEALTHCARE SYSTEMS DELIVERY AND UNDERSTANUNDERSTANDING THE NEEDF COMMUNITIES AND WE HAVE TO FACE RACISM AND WORK TOGETHER TO CALL IT OUT AND MOVE FORWARD TRANSPARENTLY AND COLLABORATIVELY. ONE THING THAT CAME OUT FOR REALLY ALL OF THE PRIORITIES THAT WE JUST PUT ON THE SCREEN IS FIRST STEP FOR MANY OR ALL OF THEM, IT'S COMMUNITY BASED RESEARCH AND WHAT WE MEAN BY THAT, IS TO TALK TO THE COMMUNITIES THEMSELVES, AND TO LET THEM TELL US WHAT THEY NEED, WHAT THEY WANT, WITH RESPECT TO PARTICIPATION IN RESEARCH, ACCESS AND NEEDS FROM THE HEALTHCARE SYSTEM. WANTING TO DONATE BLOOD AND WHAT THEY MIGHT WANT FROM A BLOOD DONOR CENTER. SO THERE ARE ALREADY MULTIPLE DIFFERENT GROUPS BECAUSE SOCIAL DETERMINANTS OF HEALTH IS NOT JUST THE HEALTHCARE SYSTEM, IT IS ACCESS TO HEALTHY FOOD AND THE ENVIRONMENT PEOPLE LIVE IN. AS WELL AS EMPLOYMENT OPPORTUNITIES, MANY, MANY THINGS THAT IMPACT SOCIAL DETERMINANTS OF HEALTH. SO WE THINK THAT OUR FIELD NEEDS TO PARTNER WITH GROUPS AND LEARN FROM GROUPS ALREADY WORKING IN THE COMMUNITY. TO HAVE AN ENTRE INTO THE COMMUNITY TO TRY TO LEARN WHAT THEY NEED, WHAT THEY WANT. WE NEED TO BE PREPARED FOR LACK OF TRUST AND HEARING THINGS THE HEALTHCARE SYSTEM OUR FIELD, OUR APPROACH TO DONOR RECRUITMENT AND TOUGH THINGS ABOUT HOW THOSE THINGS MAY HAVE OR HAD EXCLUDED MEMBERS OF DIFFERENT COMMUNITIES. BECAUSE THERE IS DESIRE AND KNOWN INTEREST TO INCREASING BLOOD DONOR RECRU RECRUITMENT, OF ALL TYPES OF PEOPLE, ETHNIC GROUPS, DIFFERENT GROUPS DIFFERENT GEOGRAPHIES ANCESTRAL BACKGROUND WE THINK HAVING BLOOD DONOR CENTERS AND REPRESENTATIVE THE BLOOD DONOR CENTERS IS PARTICIPANTS IN THIS TYPE OF LISTENING AND LEARNING WOULD BE ADVANTAGEOUS. WHEN WE TALKED ABOUT PATIENT OUTCOMES, THERE IS A LOT OF INTEREST IN PRIORITY FOUR AS WELL, WHICH IS TO REALLY BETTER CLASSIFY, KEEP TRACK OF AND LEARN HOW TO PREVENT AND TREAT ADVERSE EVENTS RELATED TO TRANSFUSION EXPERIENCED IN HIGHER PROPORTION OF PATIENTS OF MINORITY GROUPS. HOWEVER, THAT LOW -- THE LAST BULLET THERE, WE THINK RIGHT NOW WE KIND OF CONSIDER THOSE THINGS RARE. BUT MANY DON'T THINK THEY ARE RARE BECAUSE THEY ARE UNDERSTUDIED, UNDERCLASSIFIED, THERE'S NOT A LARGE FUNDING MECHANISM TO STUDY AD VERSION EVENTS SUCH AS TRANSFUSION REACTIONS SO THIS IS MULTI-CENTER AND QUITE LONG TERM STUDY, NOT JUST SHORT TERM STUDY SO FUNDING MECHANISMS HAVE TO SUPPORT THAT. COOPERATION WITH BLOOD DONOR CENTERS, COMMUNITY ORGANIZERS, POLITICIAN, CHURCH, THIS GOES BACK TO RESEARCH, WE IN OUR OFFICES AND -- ARE NOT ABLE TO SAY WHAT COMMUNITY NEEDS, WE NEED TO HAVE THEM AND ANYONE THAT WANTS TO TALK AND HELP US BETTER UNDERSTAND PATIENT OUTCOMES. THE PATIENT OUTCOMES COULD BE LACK OF TRANSFUSION WE CALLED OUT ON THE GROUP, WHERE A PATIENT LIVES, ACCESS TO TERTIARY AND QUARTERNARY CARE, GENE THERAPIES AND OTHER NEW TREATMENTS IS NOT AVAILABLE EVERYWHERE. SO THAT NEEDS TO BE RECOGNIZED STUDIED AND THOUGHT HOW IT COULD BE DELIVERED IN -- EVERYWHERE IN A MORE EQUITABLE WAY. THE LACK OF TRANSFUSION CAN BE FOR EMERGENCIES. SO FOR TRAUMA BASED CARE AS WELL AS BLEEDING, BOTH OF THOSE NEED TRANSFUSION CARE QUICKLY AND NOT ALL HOSPITALS OR HEALTHCARE FACILITIES ARE EQUIPPED FOR THAT. THERE IS RECK NICHE, WHAT CARE PATIENTS EXPERIENCE FOR THOSE EMERGENCIES DOES DEPEND WHERE THEY ARE AND WHO THEY ARE. SO THAT NEEDS TO BE ADDRESSED BOTH WITH HEALTHCARE SYSTEMS STRENGTHENING AND RESEARCH TO SUPPORT HEALTHCARE SYSTEM STRENGTHENING SO THOSE ARE BROAD THEMES THAT CAME OUT FROM OUR SESSION. I WANT TO THANK SO MANY PEOPLE WHO ALSO SPOKE UP AND GAVE REALLY SPECIFIC EXAMPLES. ONE THING THAT WAS DISCUSSED IN DETAIL WAS THE INFORMED CONSENT PROCESS. HOW THE LENGTH OF IT, THE DETAIL OF THE WRITTEN WORD AND HOW THAT DISUADES PEOPLE FROM PARTICIPATING IN RESEARCH. OTHER POINTS SPOKEN ABOUT IN TERMS OF SOCIAL DETERMINANTS OF HEALTH AND BLOOD CENTERS, THERE WAS A NICE CONNECTION MADE BY SEVERAL FOLKS ABOUT HOW NIH STARTING TO VIEW BLOOD CENTERS AS A PLACE WHERE CHRONIC DISEASES THAT IMPACT MANY PEOPLE, CAN BE TOUCH POINT FOR THE FIRST POINT OF CARE. AS WELL AS FOR YOUNG DONORS WHICH ARE OFTEN A TARGET OF DONATION RECRUITMENT IN TERMS OF ADOLESCENT BASED HEALTH. SO INCLUDING IN TERMS OF THE WHOLE COMMUNITY OF CARE FOR ALL DIFFERENT REPRESENTATIONS OF COMMUNITIES AND MINORITY GROUPS TO INCLUDE THOSE BLOOD CENTERS AND STUDY THAT TO BE ABLE TO BOTH LEARN AND TEACH AND POTENTIALLY RETAIN BLOOD DONORS BUT ALSO PROVIDE ACCESS TO HEALTHCARE OR AT LEAST THE ENTRE POINT OF HEALTHCARE. THERE ARE MANY OTHER POINTS, TRYING TO THINK OF WHAT OTHERS TO CALL OUT. THE -- BACK TO MY FIRST POINT, THEN I WILL SEND IT TO YVETTE. ABOUT COMMUNITY BASED RESEARCH AND COMMUNITY BASED LISTENING AND LEARNING, THERE WAS AN INTERESTING ANECDOTE SHARED ABOUT HOW ADVANCE STUDY BEGAN IN FLORIDA AND HOW GOING TO COMMUNITY AT LGBTQ COMMUNITY CENTER TO DESCRIBE STUDY AND LISTEN, WAS A REAL TURNING POINT FOR UNDERSTANDING HOW THE COMMUNITY WOULD RECEIVE STUDY AND ALSO THE POINT THE INITIAL DESCRIPTION OF THE STUDY WAS MET WITH A GREAT DEAL OF NOT TRUSTING SCIENTIFIC COMMUNITY. SO THOSE HAVE TO BE WORKED THROUGH TO MOVE FORWARD TO THIS IDEAL OF BROAD DIVERSITY INCLUDED IN OUR STUDY AS WELL AS INCLUDED IN OUR RESEARCHERS THEMSELVES. MY LAST POINT WILL BE THE RESEARCH PIPELINE BRING OF EDUCATING OUR YOUNG FOLKS IN ALL COMMUNITIES ABOUT SCIENCE, COMMUNITY BASED HEALTHCARE AND ADVOCACY AND ALL THESE TOPICS START YOUNG AND THERE ARE ALREADY PROGRAMS THAT MANY OF YOU ALSO LEAD AND PARTICIPATE IN AND SOME THAT OUR PROFESSIONAL SOCIETIES DO AND THOSE ARE INCREDIBLY IMPORTANT AND CONTINUE TO BE FUNDED IF NOT STUDIED TO SHOW THE IMPORTANCE OF FILLING THE PIPELINE WITH A VERY DIVERSE GROUP OF INDIVIDUALS THAT WILL ALSO MAKE THE FUTURE RESEARCH ON MORE INCLUSIVE. SO YVETTE, ANYTHING ELSE? I TRIED TO SUMMARIZE A LOT OF STUFF STUFF. IN A FEW MOMENT. >> MEGHAN, YOU DID AN EXCELLENT JOB. AGAIN, I WANT TO DO SOME OF THE SAME THINGS, THANK OUR CERTAINLY THE GROUP OF INDIVIDUALS THAT ATTENDED THE BREAK OUT SESSION BUT JUST HARDLY WORDS TO DESCRIBE REALLY HOW MUCH FUN IT WAS. TO WORK WITH OUR WORK GROUP TEAM. PERSONALITIES THAT MELD IT TOGETHER AND IT BECAME VERY COMFORTABLE FOR US TO WORK WITH EACH OTHER AND SHARE INFORMATION AND PARTNERSHIP. ALL OF US HAVE CERTAINLY NOW HAVE A NEW GROUP OF COLLEAGUES THAT WE CAN CALL ON. FOR YEARS AND YEARS TO COME AND GET THEIR OPINIONS AND THOUGHTS BECAUSE OF THE GREAT RESPECT WE HAVE FOR EACH OTHER. THE LAST THING I WANT TO ADD IS THAT BEING IN THIS SPECIFIC WORK GROUP, WE BEGAN TO ADDRESS AREAS IN RELATIONSHIP TO HEALTH DISPARITIES AND HEALTH INEQUITIES IN TRANSFUSION MEDICINE WHICH MANY NEVER DISCUSSED AT THIS LEVEL BEFORE. SO FOR MANY OF US, THIS IS NEW PLACE AND NEW SPACE AND NEW PLACE TO START THINKING SO NOW THAT THIS OPPORTUNITY HAS OPENED UP FOR US TO THINK DIFFERENTLY ABOUT WORK THAT WE DO, THE POPULATIONS WE WORK WITH AS WELL AS HAVE A COMPLETELY DIFFERENT VIEW OF OURSELVES, AND OUR ABILITY TO STEP UP AND STAND OUT AND ADVOCATE ON BEHALF OF OUR PATIENTS, THIS IS A NEW SPACE THAT MANY OF US HAVE NEVER BEEN IN BEFORE TO THIS EXTENT. WE ALL KNOW OUR RESPONSIBILITY TO WANT TO DO BEST FOR OUR PATIENTS BUT WE ARE THINKING ABOUT COMMUNITIES NOW. SO THE WORK THAT WE HAVE TO DO IN FRONT OF US IS VERY BROAD. BUT WE KNOW WE CAN DO IT. THIS IS OUR SPACE TO INHABIT. SO THAT IS THE ONLY THING I WANT TO ADD AND AGAIN, JUST THANK MY TEAM AND WORKING WITH MEGHAN HAS BEEN PURE JOY. WE WOULD JUST ENCOURAGE AND SUPPORT EVERYONE IN THIS WORK AND AGAIN THIS IS JUST THE FIRST SCENE OF THIS PLAY. SO WE HAVE A LOT OF WORK LEFT TO DO. THANK YOU. >> THANK YOU, YVETTE. BRIAN AND NAREG BACK OVER TO YOU OR ANY COMMENTS OF COURSE. I SEE SOME PEOPLE COMING OFF -- PUTTING THEIR CAMERAS ON. >> THANK YOU VERY MUCH. YOU TAKE A POSITIVE WAY TO END THE RECAP, ECHOING IN THE SPIRIT OF COLLABORATION AND THIS NEW UNIQUE FACET TO THE PART OF THE STATE OF THE SCIENCE, I CAN FOR SEE THAT CONTINUING TO THE FUTURE AS WELL. SO I WILL STOP AND SEE IF ANYONE HAS COMMENTS OR QUESTIONS. >> BEFORE YOU DO JUMP IN WITH ANY COMMENT FEEL FREE TO RAISE YOUR HAND OR USE THE CHAT BOX. THIS IS TIME FOR US NOT ONLY FOR COMMENTS FOR MEGHAN AND YVETTE BUT THE TWO OTHER WORKING GROUPS THAT PRESENTED TODAY. PLEASE FEEL FREE WE RECOGNIZE EACH OF YOU ONLY ABLE TO JOIN A SINGLE BRAINING OUT SESSION. WE PROBABLY WANTED TO ATTEND MANY MORE THAN JUST TWO OVER THE LAST TWO DAYS. WE DO HAVE A LITTLE BIT OF TIME. UPWARDS OF 20 MINUTES, WE WANT TO HAVE SOME FURTHER DISCUSSION. AND WE WANT TO TALK ACROSS GROUPS, FEEL FREE TO DO SO. THIS IS AN OPPORTUNITY FOR ALL OF TO HEAR EACH OTHER'S THOUGHTS TOGETHER. >> I WOULD SAY IF WE CAN FOCUS INITIALLY ON THE SIX WORKING GROUPS, IF THERE IS DESIRE TO PROCEED TO THE BROADER OPENNESS COURSE WE CAN DO SO PRIOR TO MY PUSH THIS PRESENTATION IN 20 MINUTES. -- MIKE BUSCH'S PRESENTATION IN 20 MINUTES. OPERATOR: QUENTIN. >> I WANT TO MAKE A BRIEF COMMENT, MEGHAN KNOWS THIS BECAUSE SHE WORKS WITH THE GLOBAL TRANSFUSION FORUM, THERE IS A LOT OF OVERLAP BETWEEN YOUR WORKING GROUP AND WHAT IS GOING ON IN LOW AND MIDDLE INCOME COUNTRIES. I THINK WE SHOULD EXPLORE OVERLAPS AND WHAT WE CAN LEARN FROM EACH OTHER BY DIRECTIONALLY, BIDIRECTIONALLY PARTICULARLY WITH DONOR PROGRAMS IN THESE SETTINGS MANY WHICH WERE INNOVATIVE IN AFRICA AND SURE YOU ARE AWARE BUT WE SHOULD LOOK INTO THAT, IT IS NOT JUST AS A WORD WE USE NOW IN GLOBAL HEALTH I'M IMMERSED IN, GLOBAL, LOCAL, GLOCAL STANDS FOR GLOBAL AND LOCAL. AND THIS IS CERTAINLY AN INCIDENCE OF SO TO SPEAK GLOCAL. THERE IS A LOT TO BE LEARNED FROM THE LOW AND MIDDLE INCOME COUNTRY SETTINGS AND PUT THE GROUPS IN TOUCH WITH EACH OTHER. >> BRIAN, OKAY IF I RESPOND? >> PLEASE. >> QUENTIN THANK YOU. WE WORK TOGETHER ON -- TWO COMMENTS I WANT TO BRING UP. ON OUR BREAK OUT SESSION BERNARDO PYATT BROUGHT UP USE OF WHAT'S APP AND THINKING FROM THE COMMUNITY BASED PERSPECTIVE, HOW DO COMMUNITIES TALK TO EACH OTHER? AND IS IT THESE DIFFERENT MODALITIES AND SHOULD THEY BE STUDIED. I PUT IN A PLUG THE BLOOD BASE PROGRAM IS INCREASING ACCESS TO SAVE TRANSFUSION IN LOW AND MIDDLE INCOME COUNTRIES SPECIFICALLY FOCUSED AT SUB-SAHARAN AFRIC AFRICA. ONE OE STUDIES LOOKS AT THE INTERVENTION FOR BLOOD DONATION RECRUITMENT AND GETTING PEOPLE IN IMMUNITY TO DONATE. ON A MORE GENERAL EXAMPLE, SORT OF EMPHASIZING WHAT QUINTON IS SAYING, THAT PROGRAM IN PARTICULAR IS A WAY THE NIH BY DOING IMPLEMENTATION SCIENCE RESEARCH IS STRENGTHENING THE HEALTHCARE SYSTEM WHERE THOSE ARE OCCURRING AND TRYING TO SHOW RESEARCH LEVEL METHODOLOGY THAT OPTION A OR B ARE TWO STUDY ARM, WHAT IS THE BETTER WAY TO INCREASE ACCESS TO BLOOD TRANSFUSION WHICH IS THE GOEL OF THOSE PROJECTS. SO THERE IS A PATHWAY THAT RESEARCH ORGANIZATION AND FUNDING CAN VERY CLEARLY PROVIDE HEALTHCARE SYSTEM STRENGTHENING, WHICH IS STILL NOT EVERYTHING THAT WE TALKED ABOUT IN OUR SUBGROUP BUT PART OF IT. SUPPORT, KNOWLEDGE, GENERALIZABLE INCREASE IN HEALTHCARE RECRUITMENT. THANKS. >> CASSANDRA. >> I WAS THINKING ABOUT COMMUNITY AND I WAS THINKING ABOUT HOW TO GET INTO THE COMMUNITY AND I WAS THINKING ABOUT PEDIATRICS AND FAMILIES. AND SO MANY CHILDREN IN DIFFERENT WAYS NEED BLOOD AND IT IS VERY HARD TO FIGURE HOW TO CONNECT TO THE COMMUNITIES AND THEY ARE ALL DIFFERENT TYPES OF COMMUNITIES OF PATIENTS THAT NEED BLOOD IN EITHER CHILDREN'S HOSPITAL OR IN -- WITH CHILDREN IN AN ADULT HOSPITAL. I WAS THINKING THAT ONE UNIQUE WAY MIGHT BE TO GET INTO THE COMMUNITIES BY HAVING -- LOOKING AT FAMILIES AND SOCIOECONOMIC DETERMINANTS OF HEALTH AND LOOKING AT IT BECAUSE SO MANY CHILDREN ARE ON MEDICAID AND THERE IS JUST -- SEEMS LIKE THAT WOULD BE AN INROAD TO TALK WITH FAMILIES AND TALK WITH VERY HARD TORR PARENTS TO GET PLACES, AND VERY HARD FOR THEM TO UNDERSTAND ABOUT BLOOD TRANSFUG. WE SPEAK TO LOTS OF FAMILIES HOW BLOOD GETS TO HOSPITALS. SOME CHILDREN HOSPITALS HAVE A BLOOD CENTER BUT MOST DONE. AND THEN I WAS JUST THINKING SOMEHOW SETTING UP WITH COMMUNITY, WHERE THERE ARE CHILDREN HOSPITALS MIGHT BE A WAY TO BRING BRING COMMUNITY CLOSER AND EDUCATE THEM ABOUT WHAT BLOOD TRANSFUSION IS ABOUT AND THEN FIND OUT WHAT THE BARRIERS ARE TO PEOPLE IN THE COMMUNITY BEING ABLE TO DONATE BLOOD. SO I WAS THINKING THAT WAS ONE AVENUE THAT MIGHT NOT HAVE BEEN HIGHLIGHTED THAT IS I THINK AN OPPORTUNITY. >> THANK YOU, CASSANDRA. GO AHEAD MIKE. >> OBVIOUSLY I WILL PRESENT LATER AND LAYING THE FOUNDATION FOR WHAT -- WHY I BELIEVE LARGE IMPORTANTLY SUSTAINABLE LINK DONOR RECIPIENT AND DISEASE REGISTRY DAY BASES ARE SO IMPORTANT OPTIMALLY LINKED TO REPOSITORIES. BUT PLEASED TO SEE PARTICIPATION IN THE MEETING OF SOME LEADERSHIP FROM SENIOR PEOPLE FROM RED CROSS AND LARGE TESTING LABS. I THINK IN MY DISCUSSION HISTORICALLY WITH NHLBI AND LEADERSHIP, NIH IS REALLY NOT THERE TO SUPPORT ESTABLISHING THE LARGE SCALE INFRASTRUCTURE NEEDED TO MAINTAIN AND ESTABLISH AND MAINTAIN THESE LARGE LINK BLOOD ORGANIZATIONS AND THE U.S. WE ARE SEEING OTHER COUNTRIES ARE LEAP FROGGING THOUGH SOME CASES YOU CAN ARGUE WE DEVELOP THE ORIGINAL PROGRAMS TO EARLY REGISTER PROGRAMS BECAUSE OF THE FRAGMENTATION OF THE U.S. BLOOD COLLECTION PROGRAMS, WE DON'T HAVE THE SYSTEMS LIKE THEY HAVE FOR EXAMPLE MILLION CANADA OR AUSTRALIA OR DENMARK THAT ALLOW A NATIONAL LONG TERM DEVELOPMENT OF SUCH DATABASES AND REPOSITORIES SO JUST TO PLANT THE IDEA THE BLOOD COLLECTION ORGANIZATIONS THEMSELVES AND THE LARGE TESTING LABS THEY OWN AND OPERATE, THEY HAVE A CERTAIN OBLIGATION. SOME OF THEM -- THEY JUST ESTABLISHED VETALIN INNOVATION CENTER, FOR ACTIVITIES TO MOVE RESEARCH FINDINGS TO REAL WORLD. I WOULD LIKE TO LAY THE GROUND WORK FOR ORGANIZATIONAL FUNDING THAT THEN IS COMPLIMENTED BY NIH AND OTHER EXTERNAL FUNDING. >> I WANT THE THEY CAN THE ORGANIZERS FOR THIS MEETING. ONE THING IMPRESS WITH MY MIND WITH THIS MEETING AND GENERAL TRANSFUSION DESPITE THE FACT TRANSFUSION IS A SMALL FIELD THE TALKS ARE INCREDIBLY DIVERSE YOU GO DOWN THE RABBIT HOLE AND REALIZE SO MANY AREAS FROM DONOR ASPECT OF GETTING THE ANTHROPOLOGY BEHIND IT TO ACTUALLY CHARACTERIZING IT TO WHAT HAPPENS IN DIFFERENT RECIPIENTS AND PATIENT POPULATIONS.S. ONE THOUGHT I HD TALKING ABOUT THIS, BASED ON A COMMENTS STEVE MADE AT THE BEGINNING OF THE MEETING IS THE TRAINING, TRANSFUSION IS UNIQUE ONE YEAR CLINICAL FELLOWSHIP WITH LITTLE RESEARCH EMBEDDED UNLIKE CARDIOLOGY OR OTHER SPECIALTIES IN MEDICINE WHERE THEY HAVE SIGNIFICANT RESEARCH TRAINING THAT YOU CAN ARGUE IS INSUFFICIENT TO BE ABLE TO PLAY FOR GRANTS. WONDER IF WILL IS OVERARCHING ASPECT THAT MAYBE BENEFIT BY HAVING -- NOT SPECIFICS IN TERMS OF HOW NIH SHOULD TO THIS BUT WHETHER THERE IS A BENEFIT FROM A PROGRAM. I TRAIN IN GLYCO BIOLOGY WHICH IS VERY ORGANIC CHEMISTRY AND INTENSE FIELD, WEIRDLY, AND NHLBI JUST FUNDED A K 12 PROGRAM FOR GLYCO BIOLOGY, WE HAVE A FOLLOW IN OUR LAB DOING THAT AND THERE'S BUNCH OF GREAT SCIENTISTS HERE AND NOT ON THIS CALL BUT POINTED OUT IF THAT WOULD BE USEFUL OVER ARCHING AND JUST ANOTHER COMMENT IN GENERAL FOR APHERESIS, NOT REALLY DISCUSSING NOT A SPECIFIC RESEARCH INTEREST OF MINE PER SE BUT SOMETHING WE ALL DEAL WITH CLINICALLY AND YOU CAN SEE PATIENTS ARE JUST NO DATA FOR MOST OF WHAT WE DO MECHANISTICALLY OR OTHERWISE SO JUST ANOTHER EXAMPLE OF SOMETHING I DON'T SUGGEST ANY WAY NEEDS TO PRIORITIZE ABOUT THINGS WE TALK ABOUT TODAY BUT SO MANY OPPORTUNITIES RESEARCH ONE LIMITATION IS JUST DON'T HAVE RESEARCH EMBEDDED IN TRAINING, SO I THINK THAT DOES LIMIT SOME OF THESE DIFFERENT ASPECTS OF DONOR SCIENCE, OTHER THINGS THAT MAY BE LEFT TO SITES BECAUSE THERE IS A STRUCTURE IN PLACE TO TRAIN PEOPLE. COULD BE WRONG BUT JUST A THOUGHT ON THAT IN GENERAL. >> RUCHIKA. >> HI. I STRONGLY -- EVERY TIME YOU GO THROUGH THE PROCESS THE QUESTION OF HOW CAN WE INTEGRATE THIS INTO TEACHING OUR -- WHETHER NEXT GENERATION OR FELLOWSHIP GRADUATES, TRAINEES, SOME WAY TO HAVE A MORE SYNCHRONIZE WAY OF MENTORSHIP, SOMETHING THAT THEY COULD DO START DURING THE TRANS-- INDEPENDENT, (INAUDIBLE) PEOPLE COMING FROM HEMATOLOGY, PULMONARY, ANESTHESIA, TRANSFUSION MEDICINE RESEARCH. BUT HAVING SOME PATHWAY THERE COULD BE UNDER ONE UMBRELLA. IF YOU HAVE AN INTEREST SOME WAY TO CONNECT TO MENTOR, STUFF CAN BE DONE REMOTELY, NOT EVERYTHING BUT (INAUDIBLE) HAS MENTORING PROGRAM, WE HAD DISCUSSION WITH CLAUDIA RECENTLY, WE WERE ON A CALL USING THE DEEP DIVE ABB DATA GROUP PROJECTS AND WE THOUGHT WE COULD USE IT TO ANNOUNCE AND SEE IF THERE ARE OTHER TRAINEES LOOKING FOR MENTORSHIP OR JUNIOR FACULTY OR SENIOR LOOKING FOR MENTORING, I THINK HAVING SOME INFRASTRUCTURE WOULD BE AMAZINGS. SOMETHING SIMILAR COULD BE DONE FOR SOME OF THE DATA SCIENCE AT LEAST SOME BASIC EDUCATION AS WELL WHICH WILL MAKE FOLKS MUCH MORE COMFORTABLE THAT EVEN UNDERSTANDING WHEN THE NEW PAPERS COME OUT SO YES, I THINK THAT IS A GREAT IDEA, SOME POINT BUILDING INTO TRANSFUSION MEDICINE EDUCATION IS HELPFUL. >> THANK YOU, RUCHIKA. YVETTE. >>S IN A GREAT CONVERSATION AROUND HOW DO WE EMBED RESEARCH IN TRAINING BUT THE I GUESS THE BROAD THINKING AROUND APHERESIS MEDICINE, WHEN YOU COME TO APHERESIS MEDICINE TOLUENE FROG OR PATHOLOGY OR HEMATOLOGY. SO USING APHERESIS MEDICINE HOW THOSE MULTIPLE MEDICAL SPECIALTIES CAN GET, SPECIFIC RESEARCH P P INFORMATION IN RELATIONSHIP TO THOSE POPULATIONS, PAINT DIVERSE POPULATIONS OF PATIENTS WHO NEED THIS ONE PROCEDURE APHERESIS. SO JUST RECENTLY THIS WAS LAST WEEK WE HAD A JOURNAL CLUB TALKING ABOUT DIFFERENT OBJECTIVE MEASURES OF TRAINING PHYSICIANS IN APHERESIS MEDICINE COMING FROM ALL THE MEDICAL SPECIALTIES AND HOW TO HAVE STANDARDIZED OBJECTIVES IN TERMS OF TRAINING. USING APHERESIS MEDICINE AS AN OPPORTUNITY TO BRING FORTH INTO ONE PARTICULAR PIECE OF DEALING WITH OR ONE PARTICULAR PROCEDURE OR ASPECT OF TREATMENT APHERESIS MEDICINE, AND THEN HAVE ALL OF THOSE MEDICAL SPECIALTIES THAT USE THIS PROCEDURE TALK ABOUT HOW THEY COULD COME TOGETHER IN RELATIONSHIP TO FUNDING, AND TRAINING AND RESEARCH AROUND APHERESIS MEDICINE WHICH IS IN MANY CASES TRANSFUSION, FALSE TRANSFUSION AS WELL. WE STARTED TA TALK TOWARD THEND OF THE MEETING AND THERE'S GOOD COMMENTS IN THE CHAT BOX AROUND DIFFERENT INITIATIVES. BECAUSE WE HAVEN'T HAD A CHANCE TO TALK ABOUT THIS AND THINK THROUGH WHAT SHOULD WE ASK FOR NIH AND NHLBI TO DO TO HELP SUPPORT NEXT GENERATION. AGAIN RECOGNIZING EVERYBODY'S EFFORT AND INTEREST IN THIS AREA, THANK YOU, FOR SURFACING IT AND GIVING A CHANCE TO RECORD IT AS A PARTS OF THE PROCEEDINGS FOR THE STATE OF THE SCIENCE TRANSFUSION MEDICINE. THOSE CHAT MESSAGES WILL BE CAPTURED. I WILL TRANSITION TO GIVE INTRODUCTION FOR MIKE BUSCH, AT LEAST MORE ME IT IS CERTAINLY A VERY STRANGE TO SEE HIM CLASSIFIED AS DIRECTOR EMERITUS OF THE RESEARCH INSTITUTE BUT WE ARE VERY HONORED TO HAVE HIM AS WELL AS WE HAVE DR. DEVINE SPEAKING ON HIS PERSPECTIVE FOR A RESEARCH CAREER IN BLOOD SAFETY AND TRANSFUSION MEDICINE. WHAT HE THINKS THE FUTURE BRINGS. SO HE HAS AN ESTEEMED CAREER WITH OVER 600 PEER REVIEWED PUBLICATIONS AS WELL AS 150 COMMENTARIES OR EDITORIAL PIECES ON THAT. SO HE DOESN'T NEED ANY MORE INTRODUCTION FROM ME, I WILL TURN IT TO MIKE. THANK YOU VERY MUCH FOR CLOSING OUT THE MEETING WITH YOUR KEYNOTE ADDRESS. >> THANK YOU. IT'S BEEN A TERRIFIC MEETING AND I WANT TO COMPLIMENT THE EXCELLENT PRESENTATIONS AND I'M HONORED TO GIVE THIS TALK. I ENJOYED ALL THE WORKING GROUP PRESENTATIONS. I THINK THIS IS EXTRAORDINARILY SUCCESSFUL, APPRECIATE STEVE'S COMMENTS AT THE BEGINNING LOOKING BACK AT THE LAST STATE OF THE SCIENCE MEETING AND I BELIEVE AS HE NOTED THAT WE HAVE MADE ENORMOUS PROGRESS ON THE IDEAS AND PROJECTS THAT WERE DELINEATED. SO SURE WE WILL DO THE SAME. IN MY TALK I WANT TO STEP BACK AND SHARE PERSPECTIVE OF STUDIES, DID BASIC RESEARCH, LAB RESEARCH, Ph.D. IN RESIDENCY BUT THEN I WAS FORTUNATE TO GET INVOLVED VERY EARLY IN MY CAREER IN THE EARLY '80s WITH AIDS AND SOME BIG STUDIES AND I WILL SHARE COUPLE OF THOSE BUT THEN TALK ABOUT THE EVOLUTION OF STUDIES AND IMPACT OF BIG DATA ON THE FIELD. NEXT SLIDE, I WANT TO RECOGNIZE TWO MENTORS AND TED KATE FOUNDING SCIENTIST SCIENTIFIC DIRECTOR RESEARCH PROGRAM AT THE IRWIN MEMORIAL BLOOD BANK WHICH I JOINED AND PASSED AWAY ABOUT NINE YEARS AGO A AND GEORGE NIMO WHO RECENTLY PASSED AWAY. I MET BOTH HERB AND GEORGE ALMOST EXACTLY THE IMSAME TIME IN 1983 AT THE BLOOD BANK IN SAN FRANCISCO AND TRANSFUSION AIDS CRISIS WAS JUST BEGINNING TO BE APAREN. AND GEORGE AT THE TIME HAD JUST TAKEN OVER THE TRANSFUSION MEDICINE BRANCH AT NHLBI AND LEADING THE FUNDING PROCESS FOR THE BIG STUDIES THAT I WILL TALK ABOUT. SO MANY OF US INCLUDING SIMONE AND RECRUITED HER TO NHLBI AND NEXT SLIDE IS A PHOTO WITH THE CONCLUDING CEREMONY AROUND THE RED TREE PROGRAM WHICH CHOSE GEORGE AND SIMONE AND ALSO STEVE KLINEMAN WHO HAS BEEN A LIFE LONG COLLEAGUE, I MET HIM AT THE SAME TIME BACK IN 1984 AND WE HAVE BEEN CLOSE FRIENDS AND COLLEAGUES COLLABORATORS THROUGHOUT THE DECADES. SO THE NEXT SLIDE IS THE FINAL RECOGNITION WHICH IS TO BRIAN AND NAREG, VERY PROUD OBVIOUSLY THAT BRIAN IS SUCCEEDING ME AS DIRECTOR. AND PROUD THAT BOTH BRIAN AND NAREG ARE THE CO-CHAIRS OF THIS SYMPOSIUM BECAUSE THEY BOTH HAVE BEEN COLLABORATORS AT MY -- OUR INSTITUTE FOR LAST 10 TO 20 YEARS, WONDERFUL TO SEE YOUNG PEOPLE SUCCEED WITHIN OUR INSTITUTE STAY BUT ALSO TO MOVE ELSEWHERE AND BE SUCCESSFUL SO THAT RECENT DISCUSSION, IF THAT WAS APPROPRIATE,S THE CRITICAL VALUE OF TRAINING AND THE NEXT GENERATION OF SCIENTISTS TO ADVANCE THE FIELD. MOVING TO THE NEXT SLIDE, COUPLE OF EARLY STUDIES, I STARTED BACK IN 1984 AND I GOT INVOLVED WITH SAFETY STUDY TSS WHICH MEASURED RATE OF HIV INFECTION IN DONATION COLLECTED PRIOR TO HIV ANN BODY TESTING SO NHLBI HAD FORE SITE AND JIM MOSLEY AND STEVE AND GEORGE AND HERB PER KENS ESTABLISH AD REPOSITORY OF COUPLE OF HUNDRED THOUSAND DONATIONS COLLECTED PRIOR TO AVAILABILITY OF SCREENING IN 1985. WHEN WESTERED WITH EARLY GENERATION ANTIBODY TESTS ABOUT .8% DONATIONS IN SAN FRANCISCO AT THE TIME WERE ANTIBODY POSITIVE. AND THAT GAVE US INSIGHT TO THE RATE OF INFECTION PRIOR TO SCREENING BUT WE ARE REQUIRED THE REAL UNDERSTANDING OF THE PRE-SCREENING RISK WAS INTEGRATION OF THAT DATA WITH DATA ON RATE OF DONATION BY PRIOR HIGH RISK INDIVIDUALS IDENTIFIED AS AIDS CASES AND TRACK TO LOOK BACK AND THEN RATES OF INFECTION OVER TIME IN SAN FRANCISCO BASED ON HEPATITIS VACCINE TRIALS CONDUCTED, BY INTEGRATING ALL THOSE DATA WE WERE ABLE TO GENERATE THE CURVE AT THE BOTTOM, WHICH IS THE RISK OVER TIME AND DEMONSTRATE THE EARLY IMPLEMENTATION OF DONOR DEFERRAL CRITERIA WITH THE REALIZATION OF TRANSFUSION AIDS FIRST CASE REPORTED FROM SAN FRANCISCO DECEMBER OF '82 LED TO DROP AND PROGRESSIVE ENHANCEMENT OF THOSE DEFERRALS, ABOUT A TENFOLD REDUCTION OF HIV RISK PRIOR TO THE AVAILABILITY OF SCREENING SO A STRONG INDICATION OF THE IMPACT OF DONOR SAFETY SELECTION CRITERIA. SO ONE FIRST BIG STUDY BUT THE NEXT ONE I WILL SHARE IS A STUDY THAT WE FUNDED EARLY ON FROM NHLBI IN THE UPPER RIGHT, ANOTHER LONG TERM MENTOR. THIS WAS A STUDY OF AFTER SCREENING WAS IMPLEMENTED WE REALIZE THE TRANSMISSIONS WERE STILL HAPPENING SO IN COLLABORATION WITH TEAM I MOVED TO THE BLOOD BANK WE SAVED 75,000 IDENTIFIED PURIFIED PBMCs FROM 25,000 SERO NEGATIVE DONATION P AND DID POOL TESTING SO CONCEPT OF POOL TESTING WHICH IS OF COURTS EMPLOYED IN THE U.S., -- OF COURSE EMPLOYED IN THE U.S. BEGAN IN A SENSE CREATING POOLS OF PBMCs FROM DONORS AND PCR AND CULTURE TESTING ENDED UP BEING PERFORMED ON THOSE POOL SAMPLES AND IDENTIFYING VIE REAMIC INFECTIOUS UNITS MISSED BY SCREENING. SO TO BEGIN MY CAREER, I WAS LUCKY TO GET INTO BIG STUDIES. SERIES OF SLIDES TO MAKE A POINT HERE, EVERYTHING WE DO IN MY EXPERIENCE HAS RAMIFICATIONS WELL BEYOND TRANSFUSION SAFETY. WITH HIV, EARLY WORK WINDOW PERIOD AND HOW TO CLOSE THE BIN DOE PERIOD FROM A BLOOD SAFETY PERSPECTIVE LED TO DEVELOPMENT OF STAGING SYSTEM FOR IDENTIFYING CATEGORIZING NEWLY DIAGNOSED PEOPLE TO WHAT STAGE OF INFECTION THEY ARE IN AT THE TIME OF DIAGNOSIS AND THIS IS STILL USED GLOBALLY AS THE STAGING SYSTEM USED IN IF ALL CURE TRIALS, ET CETERA. FOR IDENTIFYING WHEN PEOPLE CATEGORIZE WHEN PEOPLE ARE INFECTED. WE ALSO DEVELOPED EARLY ON IN ORDER TO MEASURE RISK IN DONORS WE DEVELOP INCIDENCE ASSAYS WHICH ARE INITIALLY DETUNED LESS SENSITIVE BUT NOW THERE IS A BATTERY OF ALTERNATIVE APPROACH TO DETECT RECENTLY INFECTED PEOPLE BASED ON ANTIBODY MATURATION DYNAMICS. SO THESE ARE EXTENSIVELY USED ALL OVER THE WORLD TO MEASURE HIV INCIDENCE WITH MUCH MORE PRECISION AND CAN BE ACHIEVED WITH MORE TRADITIONAL INCIDENCE MEASUREMENT METHODS SO EXAMPLES HERE HOW STUDIES IN BLOOD BANKS CAN HAVE RAMIFICATIONS IN THIS -- TELL THE SAME STORY FOR MANY OTHER VIRUSES AND INFECTIOUS DISEASE. JUST TO RECOGNIZE THE REDS PROGRAM, I'M FORTUNATE AS STEVE TO BE PEOPLE WHO HAVE BEEN IN ALL THESE PROGRAMS. REDS 1 STARTED IN '88 YOU CAN SEE THE FOLKS THERE AND REDS 2 IN 2004. ALL THESE PROGRAMS RAN INITIALLY FUNDED FOR FIVE YEARS BUT THEY TYPICALLY RUN FEW MORE IN EXTENSION BASIS EXTRAORDINARILY PRODUCTIVE, YOU CAN SEE THE CITATION AFTER THE REDS 1 AND 2 PAPERS REVIEW PAPER THAT STEVE LED. NEXT SLIDE. THE REDS 3 PROGRAM FOR THE FIRST TIME INCLUDED NOT ONLY DOMESTIC BUT INTERNATIONAL SITES. SO AGAIN CITATION HERE TO THE REVIEW PAPER FOR THE REDS PROGRAM AND DOMESTIC TEAM ABOVE LEFT AND INTERNATIONAL GROUP LOWER RIGHT YOU SEE SIMONE HAS JOINED IN REDS 2S WETAT THEN TO NHLBI AND TOOK OVER FOR GEORGE AND LED THE PROGRAMS FROM ALL THOSE YEARS AND INTERNATIONAL AND NATIONAL COLLEAGUES ON THIS CALL. NEXT SLIDE. THIS IS THE REDS 4 TEAM STILL ACTIVE AND PRODUCTIVE. ALL ARE EXTRAORDINARILY PRODUCTIVE WITH MANY DIFFERENT PROJECTS GOING ON SIMULTANEOUSLY, ENORMOUS WORK BUT ENORMOUS SUCCESS. SO THE REDS 1 PROGRAM JUST TO MENTION EARLY ON FOCUSED ON BLOOD SAFETY, SO DEALING WITH OBVIOUSLY HIV AND EARLY FINDINGS WITH HEPATITIS C AND D WORK ON ASSESSMENT AND SOME WORK ON NEW TRANSFUSION ON DONOR EPIDEMIOLOGY AND BLOOD AVAILABILITY NO SIGNIFICANT STUDIES IN TRANSFUSION RECIPIENTS. THE NEXT SLIDE. ONE EARLY AGAIN COMMITMENTS OF THE NHLBI WAS ESTABLISH REPOSITORIES. I MENTIONED TRANSFUSION SAFETY STUDY REPOSITORY IN EARLY ON HARVEY WALTER HAD HIS LARGE REPOSITORIES VIRUS STUDY SO A FEW CITATIONS TO REVIEW ARTICLES THAT DISCUSSED THE INCREDIBLE VALUE OF SPECIMEN BANKS BUILT OFF OF DONOR SAMPLES ARE NOW LINKED DONOR RECIPIENT SAMPLES SO INCREDIBLY IMPORTANT IS TO SAVE SAMPLES FROM BLOOD DONATION, SOMETHING I WISH WE COULD DO MORE AND WE DO IN A STRATEGIC WAY NOW AS I WILL TALK ABOUT A LITTLE BIT LATER BUT A FEW CITATIONS INCLUDING ONE WITH SIMONE ON THE IMPORTANCE OF REPOSITORIES AND UTILITY. AND THEN THE NEXT SLIDE -- THEY ARE GLOBAL NOW, THE BIOLINK PROGRAM IS IMPORTANT NHLBI RESOURCE THAT SAVES THESE. SO NOT ONLY DOES NHLBI FUND ESTABLISHMENT OF RESPOSITORIES BUT IN A STRATEGIC WAY THEY MAINTAIN THE SAMPLES FOR DECADES AND MAKE AVAILABLE TO BIOLINK INCLUDING FUNDING OPPORTUNITIES TO DO STUDIES USING ARCHIVE SAMPLES WHICH BECAME VALUE IN DECADES LATER. NEXT SLIDE. IN TERMS OF TRANSFUSION RISK WE HAVE HAD INCREDIBLE SUCCESS WITH IMPLEMENTATION OF DONOR CRITERIA, ILLEGIBILITY CRITERIA BUT IMPORTANTLY THE FURTHER ADVANCEMENTS IN SERO LOGIC NUCLEIC ACID TESTING DRIVING DOWN THE RISK OF THE MAJOR TRANSFUSION VIRUSES, ON THE LINES BUT THEN EVERY YEAR SEEMS WE FACE A NEW EIV THREAT SO NHLBI THROUGH THE REDS PROGRAM AND OTHER GRANT FUND HAS RESPONDED TO VIRTUALLY ALL OF THESE THREATS AND ESTABLISHED WHETHER THEY REALLY HAVE TRANSFUSION PATHOGENS, WHETHER SCREENING IS INDICATED OR WHETHER THEY ARE TRULY INFECTIOUS DISEASE BUT WE DON'T SEE TRANSMITTED BY TRANSFUSION OR CAUSING DISEASE OR SOME CASES FALSE ALARMS. SO THINGS LIKE XMRV, A DECADE OR SO AGO, ALLEGED ASSOCIATED WITH CHRONIC FATIGUE SYNDROME BUT PROVEN CONTAMINATION EVENT. SO HUGE PROGRESS BUT NEVER ENDING CHALLENGE OBVIOUSLY AS WE NOW DEAL WITH SARS 2. THERE IS CRITICAL PAPERS COMING OUT SOON PAPER LED BY (INDISCERNIBLE) WILL BE APPEARING THIS WEEK THAT FULLY DISPROVES ANY RISK OF SARS COV-2 FROM TRANSFUSIONS AND NOW DEALING WITH MONKEY POX DO WE NEED TO ADDRESS THAT SO NEVER ENDING NEED TO RESPOND TO THREATS AND DO SO IN A SCIENTIFICALLY RIGOROUS FASHION. SUMMARIZE AS WE EVOLVE OUR THINKING OVER DECADES TO ADDRESS TRANSFUSION THREATS WE ARE BUILDING A PROCESS TO CRANK THE WHEEL, SAVE SAMPLES WE ESTABLISH PREVALENCE AND RNAEMIA OR DNAEMIA AND ESTABLISH INFECTIVITY OF, VIS-A-VIS ANIMAL MODEL TRANSMISSION STUDIES AND HUMAN LINK DONOR RECIPIENT TRANSFUSION STUDIES, STUDIES ON CONSEQUENCES OF THESE DISEASES IN PATIENTSES. THIS PROCESS HOW TO ASSESS WHETHER NEWLY IDENTIFIED POTENTIAL TRANSFUSION THREAT IS A PROBLEM AND HOW TO RESPONDS TO IT IS SOMETHING THAT WE THINK OVER DECADES LEARN HOW TO DO, IT TAKES TIME AND MONEY BUT IT IS SOMETHING WE EFFECTIVELY ACHIEVE AND THE BLOOD SUPPLY IS EXTRAORDINARILY SAFE THE MOST RECENT FUNDING, ALWAYS THROUGHOUT DECADES THE REDS PROGRAM HAS BEEN FOUNDATIONAL PROGRAM THOUGH THE BULK OF THE SCIENCE EXECUTED HAS OVER TWO DECADES FOCUS ON DONOR ISSUES AND DONOR RECIPIENT EFFICACY QUESTIONS, THE PROGRAM ON WHICH NHLBI ADDS RESOURCES TO ADDRESS NEW THREATS, WITH RESPECT TO SARS COV-2 WHERE THE RESPONSE PROGRAM WAS SUPPLEMENT TO REDS SPORE PROGRAM TO ESTABLISH FREQUENCIES OF RNAEMIA DONATIONS TO DO TRANSFUSION STUDIES AND INCLUDING ANIMAL MODEL STUDIES. SO THIS IS A SUMMARY OF THE KINDS OF STUDIES THAT WE HAVE DONE OVER THE LAST FEW YEARS WITH RESPECT TO SARS COV-2COV-2. ONE STUDY WAS SERO PREVALENCE THAT STARTED AS REDS 4 STUDY IN FIVE CITIES ACROSS THE U.S. AND EXPANDED TO THE BLOOD DONOR PROVIDENCE STUDY, SO A BIG STUDY WE ESTABLISHED THAT INCLUDES 50 STATES AND PUERTO RICO AND WASHINGTON D.C. TRACKING EVOLUTION OF BOTH INFECTION AND VACCINATION OVER THE LAST TWO AND A HALF YEARS NO DETAIL ON THE FINDINGS BUT TO ILLUSTRATE WE CAN ACHIEVE THESE STUDIES THROUGH REACHING OUT TO BLOOD ORGANIZATIONS THROUGHOUT THE U.S. WHO ARE ALWAYS COLLABORATIVE AND COOPERATIVE WITH RESPECT TO PROVIDING SAMPLES AND LINKING TOGETHER THOSE SAMPLES WITH NEW TECHNOLOGY TESTS, IN THIS CASE SERO SURVEILLANCE. WORKING WITH EXPERT GROUPS IN THIS CASES WETAT TO EXECUTE WAITING -- WESTAT WAITING TO INFER FROM BLOOD DATA THE RATINGS AND IMPACT OF VACCINATIONS AND IMPACT OF VARIANTS ON TRANSMISSION OVER TIME. SO THIS WAS MONTHLY CROSS SECTIONAL TESTING OF 170,000 SAMPLES PER MONTH, BUT WE REALIZE THE END OF LAST YEAR THAT APPROACH WAS REACHING SATURATION, COULDN'T MAKE MUCH SENSE OF IT SO THAT IS WHY WE MOVE TO THIS NEW APPROACH, A REPEAT DONOR COHORT SO THIS INVOLVES ABOUT 160,000 DONORS FROM RED CROSS AND VITALA FREQUENT REPEAT DONORS HAD SAMPLES SAVED DURING PERIODS WHEN UNIVERSAL SCREENING WAS GOING ON AND WE FLAGGED DONORS IDENTITIES ANDTURING SAMPLES EVERY TIME THESE DONORS DONATE GOING FORWARD FROM JULY 2021, CAPTURING SAMPLES AND STUDYING THEM FOR CONTINUED EVOLUTION OF THEIR INFECTION. THIS ALLOWS US TO DETECT VACCINE BREAK THROUGH INFECTION AND REINFECTION, FUNDED FOR ANOTHER YEAR BUT HOPEFULLY GO ON BEYOND THAT. WITH THE VISION JUST TO MENTION THIS CONCEPT OF A GLOBAL IMMUNOLOGIC OBSERVATORY SO USING SERIAL SAMPLES FROM REPEAT BLOOD DONORS AND FLAG AND CAPTURE SAMPLES FROM THE TESTING LABS ARCHIVE THOSE SAMPLES AWAY, THAT GETS US THE ABILITY TO RAPIDLY RESPOND TO FUTURE PANDEMIC THREATS AND UNDERSTAND WHEN VIRUSES ENTERED THE BLOOD SUPPLY. SO THE REDS PROGRAM EVOLVED, I APOLOGIZE IT SHOULD SAY REDS 2 AND 3 IN THE UPPER BARS HERE. BUT THE REDS 2 PROGRAM BEGAN TO LOOK AT DONOR SAFETY ISSUES, THINGS LIKE TROLLY AND TACO BUT THE REDS 3 PROGRAM NEXT SLIDE REALLY DID SOMETHING NEW AT THE TIME, TO LINK DONORS AND RECIPIENTS AND BUILD FOR THE FIRST TIME A LINK DONOR COMPONENT RECIPIENT DATABASE. THAT IS WHERE AGAIN I WANT TO FOCUS MOST OF MY SUBSEQUENT COMMENTS,S THE POWER AND THE IMPORTANCE OF THOSE LINKED DONOR RECIPIENT DATABASE, A LOT COME OUT THROUGH THE WORKING GROUP DISCUSSION IN THE PAST COUPLE OF DAYS. SO IN IS EARLY STUDY DANA SHOWED VERSION OF THIS THATNA READ ROUBINIAN SHOWED WHERE E H LINKED THE BLOOD DONOR CHARACTERISTICS EPIDEMIOLOGIC FACTORS GENDER AGE, COMPONENT CHARACTERISTICS IN TERMS OF THINGS LIKE IRRADIATION AND STORAGE, WITH RECIPIENT OUTCOME VARIABILITIES AND DEMOGRAPHICS. AND WAS ABLE TO SHOW CERTAIN DONOR CHARACTERISTICS COMPONENT CHARACTERISTICS IMPACT THE EFFICACY. THAT LED TO A FOLLOW-UP LARGE PROGRAM TRIGGERED BY MARK AND TAMIR IN THE WORK THEY DEMONSTRATED HIGH BOTH SIDESSED DONOR VARIATION INCLUDING GENDER AND AGE BUT GENETIC VARIATION AFFECT HEMOLYTIC PROPENSITY AND CONSEQUENCE RECOVERY AND EFFICACY OF TRANSFUSION. THE NEXT SLIDE IS THE STUDY WE BUILT ONE BIGGEST THING WE HAVE DONE IS RBC OMICS STUDY, INVOLVED IN ENROLLING 14,000 DONORS PERSPECTIVELY USING DIVERSION SAMPLES TO CAPTURE ALLOQUATS OF THE PRODUCED RED CELLS, USING THE REDUCTION FILTERS TO CAPTURE WHITE CELLS AND CHARACTERIZING PHENOTYPICALLY THE PROPERTIES OF STORED RED CELLS STORED IN SPECIAL TRANSFER BAGS AND CHARACTERIZE END OF STORAGE, WITH RESPECT TO HEMOLYTIC TO PROSENSITIVE WE RECALL LARGE SUB OAT AND SHOWED PHENOTYPE REPRODUCIBLE WINDOW NORS SO HERITABLE AND EXECUTED A LARGE GWAS STUDY TO IDENTIFY LARGE NUMBER OF TRAITS CORRELATED WITH THE HEMOLYTIC PROPENSITY OF THOSE RED CELLS THAT HAD BEEN STORED FOR 42 DAYS. THOSE SAMPLES HAVE NOW BEEN EXTENSIVELY CHARACTERIZED BY ANGELO D'ALESSANDRO'S TEAM BY METABOLOMICS AND WE LOOK AT TRANSFUSION EFFICACY IN TERMS OF PRODUCTS DERIVED FROM THE UNITS -- THESE CHARACTERIZED DONORS. NEXT SLIDE. THIS SUMMARIZES NO DETAIL HERE BUT THIS IS PUBLISHED IN RECENTLY IN JCI BY PAIGE STATISTICIAN OVERSEEING THIS WORK AT RTI. THESE ARE MAJOR GENE FINDINGS, MANY TURNED OUT TO BE PROTEINS EXPRESSED ON SURFACE OF RED CELLS, AND FUNCTIONAL AND INVOLVED IN PATHOLOGICAL CONDITIONS. IN A SENSE NO SURPRISE THESE PROTEINS AND POLYMORPHISMS WITHIN THESE PROTEINS INFLUENCE ABILITY OF RED CELLS TO TOLERATE STORAGE. IMPORTANT NEW CAPACITY TO UNDERSTAND MECHANISTIC REASONS WHY RED CELLS FUNCTION DIFFERENTLY. NEXT SLIDE PLEASE. ANOTHER FOLLOW-UP FROM NAREG, PUBLISHED IN JCI WHICH TOOK GENETIC FINDINGS FROM THE GWAS AND ADDED THOSE TO HIS ANALYSIS OF TRANSFUSION EFFICACY. EFFICACY DEFINED BASED ON CHANGES POST TRANSFUSION CHANGES AND HEMOGLOBIN CREATININE AND BILIRUBIN. AND A NUMBER OF HITS IDENTIFIED BASED ON IN VITRO HEMOLYSIS CHARACTERIZATION OF SAMPLES URNED THE OUT SIGNIFICANT WITH RESPECT TO TRANSFUSION EFFICACY IN MULTI-VARIANT ANALYSIS ACCOUNTED FOR ALL THE OTHER BLOOD DONOR COMPONENT RECIPIENT FACTORS. GREAT. ANGELO AND TRAVIS, HAS DONE ENORMOUS WORK ON THE OMICS SAMPLES AND ONE INTERESTING PAPER THAT HE HAS STUDIED THAT HE DEVELOPED WAS RELATED TO EXPOSOME SO TURNS OUT THESE DONOR SAMPLES THAT WE SAVE FROZEN FROM METABOLOMICS ANALYSIS CHARACTERIZE TO IDENTIFY EXTENSIVE DIETARY MICROBIOME AND POLLUTANTS AND DRUGS IN DONOR SAMPLES SO OUR DONORS ARE HUMAN BEINGS AND EXPOSE NOT ONLY TO GENETIC CHARACTER RICKS BUT EXPOSURE CHARACTERISTICS DIFFERENT FROM DONOR TO DONOR. WE CAN IDENTIFY THOSE COMPOUNDS IN THE METABOLOMIC PROFILES AND CORRELATE THE IMPACT OF FUNCTIONAL PROPERTIES OF RED CELLS IN VITRO CHARACTERIZATION. NEXT SLIDE SHOWS ONE RECENT WORK PRODUCTS OF ANGELO'S AND GRIER PAGE'S EFFORTS WHICH IS TO COMBINE GENETIC DATA WITH METABOLOMICS DATA IN QUANTITATIVE TRAIT LOCI ANALYSIS, THE PAPER IS UNDER REVIEW BUT FOR THE FIRST TIME REALLY INTEGRATED THE FINDINGS FROM THE GENETIC POLYMORPHISMS WE IDENTIFIED WITH THE METABOLOMICS DATA THAT IS RICH AND DEMONSTRATES EVERYTHING MAKES SENSE, THAT THE GENETIC POLYMORPHISM IN DIFFERENT GENES, INFLUENCE PROTEIN FUNCTION, REFLECTED IN METABOLOMIC PROFILES OF THOSE RED CELLS. THE REDS 4 PORTFOLIO, NOT GOING TO GO INTO BUT IT INCLUDES EXTENSIVE WORK TO TRY TO IDENTIFY NEW BIOMARKERS OF RED CELL SEQUENCING USING OMIC SAMPLES AND USES WORK TO ESTABLISH BIO RBC TECHNOLOGIES FOR TRACKING SURVIVAL RECOVERY AND FUNCTION OF CELLS AND CHARACTERIZATION OF CELLS THAT DO SURVIVE. THERE IS THE VEIN TO VEIN DATABASE AND LARGE MULTI-SITE PROTOCOLS WHICH INCLUDED PRE-TERM INFANT AND RBC IMPACT STUDY WHICH WILL USE A TRANSFUSION MEDICINE ARRAY THAT IS DEVELOPED AND INCLUDES FINDINGS FROM RBC OMICS AND EXTENSIVE ADDITIONAL CHARACTERIZATION OF GENETICS OF DONORS AND BLOOD GROUP POLYMORPHISMS. THEN THE RAPID RESPONSE CAPACITY BOTH WITH RESPECT TO THE CONCERNS OVER PREP AND DONORS AND THE SARS COV-2 RESPONSE PROGRAM, I REFERENCED EARLIER. CITATION AVAILABLE FOR THAT. WHAT WE HAVE DONE HERE IN THE U.S., WE DON'T WANT TO SAY WE ARE THE ONLY ONES WHO DO THESE BY NO MEANS INCREDIBLE WORK DONE IN COUNTRIES PARALLELLING WHAT WE ACHIEVE AND I WILL TOUCH ON A FEW OF THESE OVER THE NEXT FEW SLIDES. GUSTAF IS SHOWN HERE IN THE SCANDAT PROGRAM, I REMEMBER WRITING WITH BRIAN EDITORIAL THAT ACCOMPANIEDED THE FIRST SCANDAT PAPER 15 YEARS AGO MAYBE LONGER, AND THIS IS A LINKAGE OF THE SWEDISH AND DANISH DONOR AND TRANSFUSION DATABASES WITH THE REGISTRIES, THE DISEASE REGISTRIES WITHIN THOSE TWO COUNTRIES SO BY NATIONAL REGISTRY THAT IS NOW UPDATED AND GOES BACK 20 YEARS. ALLOWS YOU TO LOOK AT DONOR CHARACTERISTICS. THERE'S NO SAMPLES, NO DETAIL CHARACTERIZATION BEYOND ROUTINE DONOR DATA BUT BECAUSE NATIONAL IDEA OF ALL DONORS AND PATIENTS EVERYONE IN THEIR LIVES, THEY EXECUTE EXTRAORDINARY STUDIES AND DOZENS OF PUBLICATIONS FROM GUSTA IF AND TEAM FROM THE SCANDAT PROGRAM. CHRISTIAN ERICSON, THE DANISH DONOR STUDY, THE SCANDAT TOOK A STEP FURTHER NATIONAL BLOOD COLLECTION ORGANIZATION AND ABILITY TO ESSENTIALLY CONSENT ALMOST 100% DANISH BLOOD DONORS TO PARTICIPATE IN THE STUDY, THEY HAVE BEEN ABLE TO ACQUIRE LONGITUDINAL SAMPLES FROM DONORS AND STUDY THEM WITH RESPECT TO MANY CRITICAL QUESTIONS THAT WERE ALL INTERESTED IN TERMS OF IRON SUPPLEMENTATION, SO EXTENSIVE GWAS DATA GENERATED AND BIOMARKER STUDIES LINK DONOR RECIPIENT SAMPLES. IS THE AUSTRALIAN SYSTEM WHICH WAS UNAWARE OF, THIS IS ERICA WOOD WHO LED THE PROGRAM OF ESTABLISHING THE AUSTRALIAN NATIONAL TRANSFUSION DATA SET. NEXT SLIDE HAS HIGH LEVEL OVERVIEW OF THAT PROGRAM BUT IT IS GOLD STANDARD IN MY OPINION AND BEING FINALIZED AND BUILT BUT IT IS REALLY BUILDS THE LINKAGE FROM THE DONORS AND INCLUDING CAPTURING SAMPLES FROM THE DONATIONS, THROUGH TO THE HOSPITAL TRANSFUSION SERVICES, AND THE RECIPIENTS AND THEN LINKING THAT WITH CLINICAL REGISTRIES THROUGHOUT AUSTRALIA IN TERMS OF DISEASE REGISTRIES AND HEALTH OUTCOME REGISTRIES. SO THIS IS THE KIND OF BIG DATA I THINK IS FUTURE OF THE FIELD I WANT TO RECOGNIZE NANCY AND THE CANADIANS HAVE BEEN FABULOUS WORK AND NANCY IN PARTICULAR HAS ALWAYS BEEN A CHAMPION OF METHODOLOGY AND THIS IS FROM THE LAST TRANSFUSION PUBLISHED OUTSTANDING REVIEW OF HOW BIG DATA RESEARCH TRANSFUSION MEDICINE SHOULD BE DONE IN TERMS OF OPPOSED HYPOTHESIS DRIVEN BASED RESEARCH WHICH IS ALWAYS INVESTIGATIONAL STUDIES THAT INVOLVE RANDOMIZATION, THOSE ARE ALWAYS IMPORTANT AND SHOULD BE DONE BUT WHEN YOU CAPTURE AND ACCURATELY CURATE AND ANALYZE BIG DATA YOU CAN ACHIEVE INCREDIBLE INSIGHTS THAT FEED INTO THE NEXT FIELD OF HYPOTHESIS DRIVEN RESEARCH. COMING TO THE END HERE, I WANT TO SAY ALL THESE GREAT IDEAS AND ACCOMPLISHMENTS, CROSS FERTILIZATION COLLABORATION, CONCEPTION, PASSION, DEPENDS ON PEOPLE. THIS IS A SLIDE OF GROUP OF PEOPLE IN THE PERKINS LIBRARY THAT UNFORTUNATELY ABOUT TO BE CLOSED AS WE MOVE TO A NEW FACILITY BUT THIS INCLUDES STEVE KLINEMAN AND GUSTAV AND NAREG AND OTHERS AND I THINK PHILLIP OR ANGELO ARE STANDING UP TAKING THE PICTURE BUT THERE IS NO SUBSTITUTE FOR HUMAN BEINGS REALLY BOUNCING IDEAS OFF EACH OTHER AND CONSOLIDATING STUDIES AND CONCEPTUALIZING THEM INTO REAL PROTOCOLS THAT NEED TO BE TRANSLATED INTO MANUALS OF OPERATION AND EMPOWERMENT ANALYSES AND SIMONE AND WE EXECUTE THOSE STUDIES AND ACHIEVE WHAT IS REALLY BEEN I THINK A REALLY INCREDIBLE PROGRESS IN OUR FIELD THAT WE HAVE ACHIEVED OVER MY CAREER AND SEE IT CONTINUING WITH MY SUCCESSORS AS WELL AS THE TEAM ON THIS CALL. JUST THIS QUOTE WHICH I SPOTTED IN A TRANTAS FUSION ABB SMART BRIEF, BUT FEEL STRONGLY ABOUT, HAVING PEOPLE WHO ARE PASSIONATE WORKING TOGETHER FOR LONG PERIODS OF TIME IS THE ANSWER. LOT OF PEOPLE THAT REALLY WATCHING THAT IS FINE BUT PEOPLE WHO ARE PASSIONATE AND ACHIEVE IT THAT I THINK ALLOW US TO ACHIEVE WHAT IS IN THE LAST SLIDE WHICH IS THE PRODUCT OF THIS MEETING WHICH IS THE EVOLUTION OF OUR FIELD TO PRECISION TRANSFUSION MEDICINE VISION. THANK YOU FOR YOUR ATTENTION. IF THERE IS TIME I WILL HAPPILY ANSWER QUESTIONS >> THERE IS TIME SO YES, PLEASE THANK YOU VERY MUCH MIKE FOR YOUR COMPREHENSIVE CONVERSATION ABOUT THE FUTURE AND THE PAST ALL TOGETHER. HAPPY FOR PEOPLE TO ASK MIKE ANY QUESTIONS THEY WOULD LIKE. PEOPLE MAY BE A LITTLE OVERWHELMED WITH ALL THAT HONESTLY BUT I WILL ASK A QUESTION. IT IS A BEAUTIFUL VISION. BUT THERE IS A LOT OF ELEMENTS TO PRECISION TRANSFUSION MEDICINE THAT WE HAVE TO WORK THROUGH. SO HOW DO WE START? DO WE JUST START WITH PATH OF OUR OWN OR SHOULD WE BE DOING FOCUS RESEARCH THAT HELPS UNDERSTAND FOR EXAMPLE, HOW MUCH DONORS ARE WILLING TO PARTICIPATE IN THOSE ACTIVITIES >> IT IS A BIG MULTI-FACETED PROCESS BUT I DO THINK WE HAVE STARTED WELL ALONG THE PATH AND IT IS CONTINUING AND AGAIN ALL THE WORKING GROUPS ALL ENJOYED THE WORKING GROUP 1 AND DONOR WHAT DOES IT TAKE TO RECRUIT INSCENT AND ENCOURAGE PEOPLE TO GIVE. AS ALLUDED TO EARLIER, A BIG PIECE OF THIS IN THE U.S. THOUGH WE ARE INCREDIBLY FORTUNATE TO HAVE THE RESOURCES WE HAVE, IN TERMS OF NIH FUNDING AND SUPPORT FROM OTHER NATIONAL ORGANIZATIONS, THERE NEEDS TO BE A COMMITMENT IN THE BLOOD ORGANIZATIONS THEMSELVES. OBVIOUSLY THEY CARE DEEPLY, THEY NEED THE DONORS SO THEY CARE ABOUT DONOR RECRUITMENT AND RETENTION, RESEARCH THAT WAS DISCUSSED. THEY WANT THEIR PRODUCTS TO BE EFFICACIOUS, THEY WANT NEXT GENERATION BETTER TRANSFUSION PRODUCTS. SO I THINK THEY NEED TO INVEST IN ESTABLISHING CAPACITY TO CONSENT DONORS ROUTINELY TO BE ABLE TO CAPTURE SAMPLES FROM OPTIMALLY SELECTED SUB SETS OF DONORS TO BE ABLE TO LINK THAT TO TRANSFUSION OUTCOMES OPTIMALLY, CAPTURING SAMPLES AND SAVING THEM AND THAT COULD BE ACHIEVED THROUGH THE NATIONAL CENTRALIZED TESTING LABS. SO WE CAN'T EXPECT THE NIH AND THE CHALLENGE THAT I FELT OVER TIME IS EVERY TIME WE BUILD GREAT REPOSITORIES AND GREAT LINK DATA SETS THAT THE STUDIES EXPIRE. THERE'S NO MORE FUNDING TO SUSTAIN THOSE DATABASES FROM REDS 2, TO REDS 3 OR 4. SO I FEEL LIKE IN A CHAMPIONING TO THE HIGHER ORGANIZATION AND OTHERS THAT THE BLOOD COLLECTION ORGANIZATIONS AND TESTING LABORATORIES IN THE U.S. NEED TO PARTNER TOGETHER AND SUPPORT INFRASTRUCTURE ON WHICH THEN RESEARCH PROGRAMS CAN BUILD AND EXECUTE THE SCIENCE, DISCOVERY WORK AND THEN THE TRANSLATIONAL WORK TO MOVE THESE PRECISION TRANSFUSION MEDICINE TOOLS INTO ACTUAL PRACTICE. >> THANK YOU, MIC. LOOKS LIKE SUNNY, YOU HAVE A COMMENT? FEEL FREE. >> I DO, I HAVE A COMMENT AND A QUESTION FOR MIKE. FIRST IT IS REALLY HARD TO FOLLOW MIKE WITH ANYTHING. YOU LISTEN TO A PRESENTATION WITH MIKE IT IS ALWAYS IN A CLASS BY ITSELF. SO IT IS AN OPPORTUNITY JUST TO SAY THE OBVIOUS, WHICH IS TO CONGRATULATE YOU ON A JUST STUNNING CAREER EVERY TIME YOU SUMMARIZE ONE-TENTH OF WHAT YOU HAVE DONE, IT IS MIND BOGGLING. BUT ANYWAY THAT IS NOT WHAT I NEEDED. ONE THING THAT CAME UP IN TOWARD THE END OF THE SOS, I THINK WAS REALLY IMPORTANT, YOU TOUCHED ON IT MIKE. WITH YOUR COMMENTS TRYING TO PREPARE NEXT GENERATION. WE HEARD A LOT OF INTERESTING COMMENTS ABOUT THE IMPORTANCE OF TRANSFUSION MEDICINE EDUCATION ESPECIALLY IN TRAINING RESEARCH IN TRANSFUSION MEDICINE. THE INADEQUACY OF A ONE YEAR FELLOWSHIP TRAINING PROGRAM. CLINICAL TRANTAS FUSION MEDICINE IN ONE YEAR GOD FORD BY ALSO DOING RESEARCH TECHNIQUES AND HOW TO POOL OFF RESEARCH SO YOU SAID YOU WERE INCREDIBLY LUCKY TO HAVE FALLEN IN THE CIRCUMSTANCES THAT FOSTERED YOUR RESEARCH. AND I TAKE THAT POINT. I SEE THE ELEMENT OF LUCK THAT WAS THERE BUT WE KNOW IT WASN'T JUST LUCK, RIGHT? THERE WAS SOMETHING ABOUT YOU AND SOMETHING ABOUT THE PEOPLE WHO HELPED TRAIN YOU AND GUIDE YOU. I WOULD BE INTERESTED IN REFLECTING ON YOU REFLECTING YOUR OWN CAREER. IF YOU COULD HAVE ANYTHING, WITH RESPECT TO TRAINING FUTURE TRANSFUSION MEDICINE RESEARCHERS, WHAT WOULD THAT BE? HOW DO YOU THINK WE SHOULD CHANGE WHAT WE DO TO IMPROVE GENERATION OF RESEARCHERS? >> THANKS FOR THE COMMENTS. I FEEL THE SAME ABOUT YOU AND YOUR CAREER. FABULOUS. I DID I GUESS STUMBLE IN TO A SITUATION BUT I PUT MY HEART AND SOUL INTO IT FOR THE SUBSEQUENT 40 YEARS. I DID IT WITH PEOPLE WHO ARE PASSIONATE AND COMMITTED. SO HE CAME INTO WORK UNTIL A WEEK BEFORE HE DIED IN '92. LOVED EVERY MINUTE OF TRAINING PEOPLE, HE CONTINUED TO TRAIN ALL THE FELLOWS AND LEAD THE TRANSFUSION MEDICINE FELLOWSHIP PROGRAM. USDS IS STILL ACTIVE TRYING TO GET MONEY SUCCESSFULLY BUT JUST BEEN EXAMPLE OF SOMEONE WHO HAS JUST PUT THE METAL ALL THE TIME. SO I FEEL LIKE I WAS FORTUNATE AND AGAIN WITH NIH AND PEOPLE LIKE GEORGE AND SIMONE ON MY SIDE. BUT I THINK WHAT IS ALSO TRUE IS I CARE DEEPLY AND SURROUNDED -- BEEN FORTUNATE TO RECRUIT AND SURROUND MYSELF WITH YOUNG PEOPLE WHO DID STAY ON. THEY DID THE TRANSFUSION MEDICINE FELLOWSHIP AND THEN THEY EITHER STAYED OUR INSTITUTE FOR BRIEF PERIOD, MANY OTHERS WHO BECOME GREAT LEADERS IN THE FIELD, OR THEY STAYED ON AND BECOME INCREDIBLY PRODUCTIVE AND COLLABORATIVE IN OUR INSTITUTE. THAT REQUIRED THE INSTITUTE. WHAT WE HAVE SEEN UNFORTUNATELY IS DEMICE OF ALMOST ALL WHAT USED TO BE SUCCESSFUL TRANSFUSION MEDICINE RESEARCH PROGRAMS IN THE US. I WON'T NAME NAMES BUT MANY OF THEM HAVE EITHER STOPPED COMPLETELY OFFER STRUGGLING TO MAINTAIN INTERNAL FUNDING TO SUPPORT RESEARCH PROGRAMS. THIS IS A TRAGEDY. THE PROGRAMS LIKE OURS THAT ARE ABLE TO CONTINUE TO BENEFIT FROM INTRAMURAL FUNDING IS WHAT IS CRITICAL, WE JUST MOVING INTO A BRAND NEW INSTITUTE FACILITY. THE INVESTMENT OF OUR TALENT TO DO THAT IS WONDERFUL. A COMMITMENT TO SUPPORT INVESTIGATORS AT ALL STAGES TO SUPPORT SUMMER INTERNSHIPS AND FELLOWSHIP PROGRAMS, WE CAN'T EXPECT AND WE ARE A SMALL FIELD SO WE CAN'T SUCCESSFULLY COMPETE IN MANY CASES FOR LARGE SCALE TRAINING GRANTS, THE ONE WE HAD HISTORICALLY THAT ARE BROOD BANK FOCUSED UCSF NOW MOVED TO CELLULAR THERAPY FOCUS. THEY CHANGE TACK. SO IT REQUIRES COMMITMENT BACK TO EARLIER COMMENTS, IT REQUIRES COMMITMENTS OF THE NATIONAL BLOOD ORGANIZATIONS THAT WE NEED TO SUSTAIN AND RECOGNIZE THE INSTITUTES, WE LIKE TO SEE TRAINING GO ON EVERYWHERE RESEARCH OPPORTUNITIES, NATIONAL THANKS TO LARGE PROGRAMS NHLBI FUNDED, THAT BECOMES COLLABORATIVE ACTIVITY THAT DISSEMINATES OUT BEYOND THE HANDFUL OF INSTITUTES THAT LEAD IT AND DRIVE IT. BUT I THINK IT IS THAT LONG TERM COMMITMENT OF THE BLOOD ORGANIZATIONS THAT I FEEL LIKE WE MANAGE TO MAINTAIN BUT BARELY AND WE NEED TO KEEP ON THEM TO SUPPORT RESEARCH AND SUPPORT INFRASTRUCTURE. >> DR. YOUNG, WOULD YOU LIKE TO MAKE A COMMENT? >> HI. FIRST OF ALL, CONGRATULATIONS ON JUST SUCH INCREDIBLE CAREER. IT IS GREAT TO HAVE LUMINARIES LIKE YOU TO LOOK UP TO AND THANK YOU FOR THE GREAT TALK. ONE THING I HAVE BEEN THINKING ABOUT AS I LISTEN TO YOUR TALK AS WELL AS OTHERS IN THIS AFTERNOON, AND MORNING MUCH OF TRANSFUSION MEDICINE IS NOT ISN'T AMENABLE TO HYPOTH HYPOTHESIS. HYPOTHESIS BASED RESEARCH, A LOT IS QUITE EXPLORATORY. LOOKING AT DONOR MOTIVATION IS EXPLORATORY RESEARCH. NOT HYPOTHESIS DRIVEN. . AS IS SORT OF THE DONOR RECIPIENT DATABASE, REALLY LENDS ITSELF TO LOT OF EXPLORATORY RESEARCH, NOT NECESSARILY HYPOTHESIS DRIVEN AT THIS STAGE, NOT A LOT OF MECHANISTIC QUESTIONS, AVAILABLE IN OUR FIELD WHICH IS DIFFERENT THAN MAYBE SOME OTHER AREAS OF MEDICINE. I GUESS MY QUESTION IS, HOW WILLING IS NIH TO SUPPORT THIS FIELD AND THIS TYPE OF APPROACH BECAUSE THAT IS IN MY EXPERIENCE BEEN ONE OF THE CHALLENGES IN PROPOSING AND GETTING FUNDED >> THAT MIGHT BE A QUESTION FORESI MOAN. I THINK THE OTHER POINT TO MAKE IN RESPONSE THINGS HAVE EVOLVED SO DRAMATICALLY WITH COVID-19 THE LAST TWO DAYS HAVE BEEN A STRUGGLE BECAUSE FROM MIDNIGHT MY TIME UNTIL 8 A.M. OVERLAPPING BEGINNING OF THIS MEETING THERE'S BEEN A WHO WONDERFUL MEETING ABOUT HOW TO BE READY FOR THE NEXT PANDEMIC X, IT IS JUST -- BUT IT IS CHANGED OUR LIVES PRETTY DRAMATICALLY AND I THINK IT IS CHANGED RESEARCH. VIRTUALLY EVERYONE WHO IS DOING ANY KIND OF RESEARCH FROM BASIC THROUGH TRANSLATIONAL AND EPIDEMIOLOGIC OBSERVATIONAL RESEARCH PIVOTED TO WORK ON COVID-19. A LOT OF INCREDIBLE PRODUCTIVITY HAS BEEN ACHIEVED THROUGH OBSERVATIONAL STUDIES AND JUST RESPONDING URGENTLY TO CRISIS WE HAVE LIVED THROUGH. SO I HI IT IS KIND OF AN OPPORTUNITY FOR RESET AND I WOULD LIKE TO HEAR NHLBI RESPONSE AND OTHERS, I FEEL LIKE RESEARCH WE DO IS REAL RESEARCH AS STEVE SAID AT THE BEGINNING THERE'S ALL DIFFERENT KINDS OF RESEARCH AND IT HAS TO BE GOOD RESEARCH AND HAS TO BE IMPACTFUL BUT THERE IS VALUE TO THE KIND OF RESEARCH YOU JUST SUMMARIZED INCLUDING OPERATIONAL ISSUES LIKE DONOR MOTIVATION RETENTION THIS IS CRITICAL. SIMILAR MOAN ARE YOU ON? >> I'M ON AND I WANT TO SAY THAT ABSOLUTELY I THINK THOSE LAST TWO DAYS HAVE SHOWN ACTUALLY THE VERY IMPORTANT RESEARCH QUESTIONS THE FIELD HAS. SO OF COURSE THIS IS FOR THE WHOLE COMMUNITY TO CONSIDER. AS YOU KNOW, BUT OF COURSE NHLBI WILL ALSO LOOK AT THOSE PRIORITIES. CLEARLY, I'M PERSONALLY ALTHOUGH AS YOU KNOW I REALLY LOVE THIS FIELD, BUT I'M STILL IN AWE ABOUT BREADTH OF THE RESEARCH AND POSSIBILITIES YOU HAVE IN FRONT OF YOU. I ENCOURAGE YOU TO WHEN YOU HAVE A RESEARCH IDEA IN MIND YOU COME UP WITH SOME AIMS AND CALL US. >> ALL RIGHT, THANK YOU VERY MUCH DR. GLYNN. ENCOURAGEMENT, I THINK YOU WILL HEAR FROM PERHAPS MORE THAN A FEW PEOPLE. I MAKE ONE COMMENT, MIKE. LINKING TO WHAT YOU SAID. I THINK ADMIRAL LEVINE OPENING COMMENTS AT HIGHEST LEVEL OF HHS THERE IS A CURRENT CLEAR INTEREST THAT, IS A LEVERAGE POINT FOR US SO WE NEED TO TAKE ADVANTAGE OF THAT. WE WILL DO OUR BEST AS CO-CHAIRS AND ORGANIZING COMMITTEE OF THE STATE OF THE SCIENCE TRANSFUSION MEDICINE TO DO THAT. WHAT WE WILL DO NOW IS TURN TO SOME WRAP UP COMMENTS THAT NAREG AND I WILL MAKE ABOUT WHAT WE HEARD THE LAST COUPLE OF DAYS AND WHERE WE GO FROM HERE. SO TURN IT TO YOU TO START NAREG. >> CAN YOU SEE MY SCREEN? >> YES. >> THANK YOU MIKE FOR THE PRESENTATION ONE SEGUE. AS A PULMONOLOGIST BROUGHT INTO FIELD OF TRANSFUSION MEDICINE, REALLY WAS BEING SURROUNDED BY GREAT MENTORS, BY PEOPLE AROUND YOU MADE THE DIFFERENCE FOR ME PERSONALLY. FEW COMMENTS, THE ORGANIZING COMMITTEE PICKED A FEW EXAMPLES OF COMMON THEMES RESEARCH PRY YOURS ACROSS THE WORKING GROUPS THAT INDEPENDENTLY IDENTIFIED AREAS OF FOCUS. AREAS OF FOCUS TO BRING US BACK TO THE LET ME MOVE MY SCREEN, I AM LOOKING. THERE IS A FOCUS FOR THE 2022 STATE OF SCIENCE TRANSFUSION MEDICINE, INCLUDE INCREASING DIVERSIFYING THE BLOOD DONOR POOL IDENTIFYING WHICH BLOOD PRODUCTS WIDOW NORS BEST MEET THE CLINICAL NEEDS OF SPECIFIC RECIPIENT POPULATIONS HELPING ENSURE SAFE EFFECTIVE TRANSFUSION STRATEGIES RECOGNIZING THESE MAY DIFFER FOR DIFFERENT RECIPIENT POPULATIONS. SO I THINK OVER THE PAST TWO DAYS WE HAVE TOUCHED ON NUMBER OF THESE CONCEPTS ACROSS THE SIX WORKING GROUPS. MAINTAINING ROBUST DIVERSE BLOOD DONOR POOL, THIS IS AS NOTED RECENTLY BEEN AMPLIFIED IN SETTING OF BLOOD SHORTAGE INCLUDING PART OF COVID-19 AS WELL AS NEEDS FOR SPECIAL POPULATIONS. WE HAVE SPOKEN ABOUT NEEDS FOR COMPONENTS AND RECIPIENTS, WIDOW NORS WHICH PRODUCTS FOR BROAD RANGE OF RECIPIENTS ACROSS THE RANGE INCLUDING NEONATE AS WELL AS FOR VARIOUS CLINICAL SCENARIOS, BE IT SURGICAL, NON-SURGICAL, SITUATIONS OF HEMORRHAGE, PATIENTS WITH MALIGNANT CONDITIONS. THEN WITH OVERLAP FOCUSED ON BLOOD SAFETY AND EFFECTIVENESS, MINIMIZING MITIGATING RISK. IDENTIFYING EXPANDING UPON EFFICACY EFFECTIVENESS OUTCOMES AND AGAIN IN VARIOUS PARTICULAR POPULATIONS, WITH EVEN COMMENTS DURING THE BREAK OUT ABOUT RED CELL OR PLATELET EFFECTIVENESS OR CLEARANCE NOT JUST POST TRANSFUSION BUT DOWNSTREAM. WITH MIKE'S PRESENTATION, FOR BRINGING THIS TOGETHER THIS VISION OF PRECISION TRANSFUSION MEDICINE. CAN WE INTERFACE BETWEEN BASIC CLINICAL SCIENCE TO IDENTIFY WIDOW NORS USING FOR EXAMPLE, GENOMIC OR GENOTYPING METABOLOMICS OR HEMOLYSIS MEASURES OR OTHER BIOMARKERS MEET THE NEED FOR SPECIFIC RECIPIENTS ACROSS THE AGE SPECTRUM BY TRANSFUSION INDICATION OR CO-MORBIDITY. THAT INCLUDES DONOR OUTREACH SELECTION AND RETENTION IN MANY CASES SO THIS IS CONCEPT OF PERSONALIZED PRECISION MEDICINE IS ONE THAT HAS COME UP OVER PAST FEW DAYS ACROSS THE THREAD OF SIX WORKING GROUPS AND JUST WANTED TO TOUCH ON THAT AS WELL AS LET BRIAN DO SO. >> THANK YOU, I AM GOING TO BUILD ON WHAT NAREG SAID. SO WE HAVE VISION FOR PRECISION TRANSFUSION MEDICINE. SOME MIGHT CALL IT PERSONAL TRANSFUSION MEDICINE. WHAT I THINK RAISES IS AN OPPORTUNITY BUT WE SEE IT AS DIRECTLY MEETING THE CHALLENGES THAT WE HAVE TO FACE HEAD ON WITH RESPECT TO HEALTH DISPARITIES. CAN WE HAVE THEM BOTH. SO NO, WE CAN'T HAVE THEM BOTH. WE HAVE TO FIGURE HOW TO OVERCOME HEALTH DISPARITIES AND ACCESSING DONORS, TO PROVIDE COMPONENTS TO RECIPIENTS BUT DOING SO IN WAYS THAT ARE APPROPRIATE TO THE COMMUNITIES THAT WE SERVE. I SEE THIS AS A HUGE OPPORTUNITY BUT PERHAPS EVEN MORE REALLY IMPORTANT CHALLENGE WE FACE. THERE IS A LOT TO UNPACK AROUND THAT. CLEARLY WE WILL BE TRYING TO DO SO AS PART OF THE PROCEEDINGS OF THIS MEETING. THAT IS ALL TO SAY ABOUT THAT. I WILL GO ON TO SIMPLER TOPICS WHICH ARE EASIER JUST TO START TO SUMMARIZE NAREG SHARED THOUGHTS ON COMMON THEMES AND I WILL SHARE A COUPLE BEFORE WE TALK NEXT STEPS. SO WE HAD DISCUSSIONS AROUND INCREASING DIVERSIFYING THE BLOOD DONOR POOL AND SPECIFIC WORKING GROUPS FOCUSED ON DIFFERENT ASPECTS OF THAT. HONESTLY THAT WAS MY INTENTION, WE WANTED PEOPLE THINKING ABOUT HOW WE BRING DONORS IN, WHAT ARE THE ISSUES RELATED TO SUFFICIENCY OF THE SUPPLY BUT WE ALSO WANTED AN INDEPENDENT VOICE, WHAT DO WE HAVE WITH RESPECT TO DONOR RECIPIENT DISPARITIES AND HOW IMPORTANT ARE THOSE. BUT THERE ARE THOSE THEMES THAT CLEARLY ARE VERY CLOSE CONNECTED WITH THE WORK THOSE TWO DIFFERENT WORKING GROUPS DONE, ONE ARE MOTIVATORS AND BARRIERS TO INITIAL AND REPEAT DONATION. PARTICULARLY AMONG YOUNGER INDIVIDUALS AN PEOPLE WITH DIVERSE BACKGROUNDS CURRENTLY UNDERREPRESENTED IN DONOR POOL AND WHAT ARE EFFECTIVE STRATEGIES FOR OVERCOMING BARRIERS PARTICULARLY DIVERSE POPULATIONS OR COMMUNITY OF COLOR. SO WORK TOGETHER TO MELD TWO WORKING GROUP PRIORITIES INTO RESEARCH AGENDA THAT ADDRESSES ALL THAT SIMULTANEOUSLY OR WE WON'T BE SUCCESSFUL. WE HAVE THIS BROADER OR ADDITIONAL ASPECT OF THE SOCIAL MILIEU OR THE SITUATION WE FIND OURSELVES IN IN. UNRELATED TO RESEARCH PARTICIPANTS AND WILLINGNESS TO BE PART OF STUDIES, THAT IS MUCH MORE THAN JUST INDIVIDUAL CONVERSATION THAT IS ALL OF THOSE OTHER FACTORS THAT CONTRIBUTE TO WILLINGNESS TO PARTICIPATE OR NOT AND WORK WITH US SO WE FACE CHALLENGES BUT OPPORTUNITIES. THIS IS RECOGNIZING TWO VERY DIFFERENT WORKING GROUPS FOCUSED ON THINKING ABOUT THESE THEMES BUT COMMON IDEA HOW THE USE SOCIAL MEDIA, OR DIGITAL COMMUNICATIONS TO BE MORE EFFECTIVE COMMUNICATORS WITH BLOOD DONORS OBVIOUSLY DATA SCIENCE UNDERPINS THAT HOW THE FIELD IS GOING BUT THERE IS MORE DIRECT HOY IS IT EFFECTIVE AND HOW TO MEASURE EFFECTIVENESS IN DONORS THEMSELVES SO NO ANSWERS JUST COMMON THEMES THAT ALLOW US TO PROPOSE RESEARCH QUESTIONS AND STUDIES THAT CAN LOOK AT THIS IN MORE DETAIL. >> PARALLEL ACROSS THREE WORKING GROUPS WE SAW COMMON THEMES RELATED TO VEIN TO VEIN DATAB DATABASES, THE DATA METHODS GROUP MULTI-DIMENSIONAL VEIN TO VEIN DATABASES CURATED TO ANSWER SPECIFIC RESEARCH QUESTIONS AND SPECIFIC FOCUS ON SPECIAL POPULATIONS OR RARE OUTCOMES WHERE LARGE SCALE DATABASES IS PERHAPS NECESSARY. OPTIMIZING FOCUS ON EFFECTIVENESS BUT LINKING IN WHAT THE ROLE OF DONOR COMPONENTS WERE AS PART OF VEIN TO VEIN DATABASE. ONE CAN VIEW ROLE OF CONVALESCENT PLASMA AS ANOTHER FORM OF VEIN TO VEIN DATABASE RECOGNIZED IN OBSERVATIONAL STUDIES THAT THERE WERE FACETS OF THE DONOR INCLUDING THEIR IMMUNE TITERS, ANTIBODY TITERS RELEVANT TO OUTCOME OF RECIPIENT AND HOW THIS WAS NEEDED TO BE STUDIED IN CLINICAL TRIAL AND OBSERVATIONAL FASHIONS. INTEGRATING GENOMICS INTO CLINICAL TRANSFUSION WORK FLOW, THIS IS RECOGNIZED AN APPROACH TO RARE GENOTYPES BUT IDENTIFYING THE BEST DONOR FOR RECIPIENT IS ANOTHER FACET OF THIS CONCEPT. THE EVER PRESENT FOCUS ON BLOOD SAFETY IS -- REMAINS HIGHLY RELEVANT. THIS CAME UP IN FOUR WORKING GROUPS. IN THE BREAK OUT SESSION THIS WAS RAISED TO SOME EXTENT OPTIMIZING CLINICAL OUTCOMES NON-INFECTIOUS HAZARDS OF TRANSFUSION PART OF THE EMERGING INFECTIONS WORKING GROUP ROLE OF PATHOGEN REDUCED BLOOD PRODUCTS TO MITIGATE EMERGING PATHOGENS. MECHANISTICALLY SPEAKING RECOGNIZING THESE ADVERSE OUTCOMES AND RECIPIENTS HOW WE MORE BROADLY UNDERSTAND PATHOYENSIS OF ADVERSE EVENTS AND BETTER UNDERSTAND QUALITY IN TERMS OF MITIGATING EVENTS. RECOGNIZING THERE ARE DISPARITIES IN MINORITY DIVERSE BACKGROUND POPULATIONS WHERE WE SEE HIGHER ADVERSE EVENT RATES AND HOW CAN WE BETTER STUDY THOSE AND MITIGATE THOSE IN THE FUTURE. THEN MEASURING EFFECTIVENESS, ACROSS MULTIPLE WORK GROUP GROUP GROUPS. CLINICN MAKING FOR RED BLOOD CELL TRANSFUSION WAS EVER PRESENT TOPIC IN THE OPTIMIZING CLINICAL OUTCOMES GROUP. THIS IS AN AREA OF FOCUS TRYING TO UNDERSTAND HEMOSTATIC AND NON-HEMOSTATIC PROCESSES FOR PLATELET TRANSFUSION IMMUNE ASPECT OF THE TRANSFUSION THAT ARE NOT WELL UNDERSTOOD. CLEARLY MECHANISTICALLY APPROACHES TO BETTER UNDERSTANDING WHAT WE ARE DOING, HOW WE ARE DOING IT AND WHY WE ARE DOING IT FOCUSING ON METHODS AND STRATEGIES FOR UNDERSTANDING BOTH BLOOD PRODUCT EFFECTIVENESS AND EFFICACY. MECHANISMS FOR TRANSFUSION. LASTLY, FOR THE FOCUS ON NEW RESEARCH METHODS, THE USE OF BIG DATA OR SCALABLE TECHNOLOGIES ARTIFICIAL INTELLIGENCE, MACHINE LEARNING BLOOD FLOWS ON THE BLOOD BANKING SIDE AS WELL AS TRANSFUSION MEDICINE, THIS TOPIC ALSO CAME UP IN BREAK OUT SESSION FOR OPTIMIZING CLINICAL OUTCOMES RECOGNIZING PERHAPS LABORATORY TRANSFUSION THRESHOLDS SUCH AS PRE-TRANSFUSION HEMOBLOW BIN LEVEL OR PLATELET COUNTS ARE NOT THE MOST EFFECTIVE APPROACH TO TRANSFUSION DECISION MAKING AND MAY TAKE USE OF LARGER SCALE HEMODYNAMIC OR PHYSIOLOGIC DAYTIME ON PATIENTS AND UNDERSTANDING -- DATA ON PATIENTS AND WHICH IS CLINICAL DECISION MAKING AND EFFECTIVENESS OF WHAT THAT TRANSFUSION IS, USING LARGER SCALE DATA. SO THIS IS THE FIRST STEP OF PROCESS. WE HAD THE OPPORTUNITY TO PRESENT DRAFT RESEARCH PRIORITIES AND RECEIVE YOUR FEEDBACK AND INPUT. NEXT IS TO HAVE WORKING GROUPS RECONVENE TO DIGEST AND THINK THROUGH COMMENTS RECEIVED AND HOW THAT MAYBE MAY FORMALLY REVISE PRIORITIES. WE HAVE OPPORTUNITY FOR ADDITIONAL DIALOGUE AND FEEDBACK DURING THE UP COMING AABB MEETING IN OCTOBER. WE ALSO HAVE AN EMAIL ADDRESS WHICH WILL BE PROVIDED DIRECTLY TO REGISTRANTS BUT LET YOU KNOW ADDRESS WILL DIRECTLY REACH MEMBERS OF THE ORGANIZING COMMITTEE AND MEMBER OF NHLBI AND OASH. AS HAS BEEN DONE IN THE PAST, THERE MAY BE SPECIFIC WORKSHOPS OR SYMPOSIUM THAT BASED UPON THIS DISCUSSION, WILL BE HELD IN THE FUTURE BY NHLBI AND OASH. >> SO YES, AS INDICATED THERE IS AN OPPORTUNITY FOR FURTHER DIALOGUE SO WE DO ALL RECOGNIZE THE EXPERIENCE OF HAVING TO TRY TO HAVE THE STATE OF THE SCIENCE IN TRANSFUSION MEDICINE AS VIRTUAL MEETING, NOT HAD NEARLY THE TIME TO REALLY HAVE SIDE BAR CONVERSATIONS AND OPPORTUNITIES FOR SPARK IDEAS. SO WE ARE VERY HAPPY TO BE ABLE TO SAY WILL IS ONE MORE IN PERSON OPPORTUNITY FOR PEOPLE TO GET TOGETHER AND TALK ABOUT THE WORK DONE HERE BY ALL WORKING GROUPS AND WHAT IS PRESENTED THE LAST COUPLE OF DAYS. THAT IS GOING TO BE THE AABB NATIONAL BLOOD FOUNDATION RESEARCH AND DEVELOPMENT FORUM THAT WILL TAKE PLACE AT THE ANNUAL MEETING. TO BE HELD OCTOBER 3 FROM 7 A.M. TO 8:30, NOT A LONG PERIOD BUT IT IS GOING TO ALLOW US SIX SIMULTANEOUS ROUND TABLE DISCUSSIONS LED BY ONE OR MORE WORK GROUP CHAIRS AND MEMBERS. SO AGAIN PEOPLE WILL MEET SIMULTANEOUSLY, THIS MEANS YOU WILL HAVE TO CHOOSE SPECIFIC GROUP IF YOU CHOOSE TO PARTICIPATE IN THE MEETING ITSELF, BUT WHAT IT ALSO WILL BE IS AN OPPORTUNITY FOR ADDITIONAL 60 MINUTES OF CONVERSATION ABOUT EACH OF THE RESEARCH PRIORITIES SO WHAT YOU CAN DO IS IF YOU DO SIGN UP FOR THE AABB ANNUAL MEETING YOU CAN SELECT ONE OF THE ACTUAL ACTIVITIES YOU WILL ATTEND SO IT IS IMPORTANT FOR YOU TO BE ABLE TO -- IF YOU WANT TO PARTICIPATE IN THAT SIGN UP SO THEY CAN MAKE SURE TO ACCOMMODATE ALL INTERESTED INDIVIDUALS WHO WANT TO PARTICIPATE. IN ADDITION TO THAT DIALOGUE, BETWEEN NOW AND BEGINNING OF OCTOBER IS A CHANCE FOR THE WORKING GROUPS TO RECONVENE AND THINK HOW THEY MIGHT MODIFY OR LISTEN TO AND REFLECT ON THE COMMENTS RECEIVED. THEN THERE IS THE LISTENING SESSION AND OPPORTUNITY FOR THE ROUND TABLE DISCUSSIONS AS PARTS OF THE FORUM, WHAT HAPPENS WITH ALL THAT INFORMATION? THERE IS DIFFERENT REPORTS GENERATED, OF COURSE VERY MUCH IN KEEPING WITH PREVIOUS STATE OF THE SCIENCE AND TRANSFUSION MEDICINE. FIRST REPORT WILL BE WRITTEN REPORT PRIORITIES DEVELOPED AND WORK CLOSELY TO DEFINE NHLBI WEBSITE AND SHARED WITH OTHER ORGANIZATIONS. THIS WILL BE THE FIRST FORMAL REPORT OF THE PROCEEDINGS, OF THE 2022 SOS TRANSFUSION MEDICINE. IT WILL INCLUDE OVERARCHING INTRODUCTORY COMMENTS WE WILL WRITE AS ORGANIZING COMMITTEE AND HIGH LEVEL SUMMARY OF THE LIST OF PRIORITIES DEVELOPED BY EACH WORKING GROUP. WE ALSO WILL FOCUS ON CROSS CUTTING THEMES IDENTIFIED BY MORE THAN ONE GROUP WHAT WE THINK THAT MEANS, EXPECTED TIME LINE FOR THIS IS LATE OCTOBER TO EARLY NOVEMBER. WHERE THIS WOULD BE AVAILABLE ON THE WEBSITE SO WE HAVE TO WORK THROUGH THAT BUT THAT IS THE EXPECTED TIME LINE SO IT WILL BE ABOUT A MONTH AFTER THE MEETING THAT THIS IS AVAILABLE. IN ADDITION THERE IS A FORMAL PUBLICATION THAT WILL BE -- THE TRUE PROCEEDINGS AS REPORTED, MANUSCRIPT DEVELOPED COMBINING ALL THE DIFFERENT PRIORITIES AND ALSO INCLUDING REFLECTION ON PROGRESS WE HAVE MADE AS A SCIENTIFIC COMMUNITY SINCE 2015 STATE OF SCIENCE TRANSFUSION MEDICINE. SO WHATEVER WE ACHIEVE, WHAT WE HAVE YET TO ACHIEVE AND HOW THE NEW PRIORITIES LINK TO PREVIOUS STATES IN THE SCIENCE. IN ADDITION, ONE OF THE THINGS WE HAVE BEEN EXCITED TO BE ABLE TO TELL ALL THE WORKING GROUP MEMBERS AND PARTICIPANTS IS THE OPPORTUNITY FOR TRUE DEEP DIVE THEY HAVE DONE THINKING WHAT THE RESEARCH PRIORITIES SHOULD BE, AND OPPORTUNITY TO WITHIN THAT WORKING GROUP PUBLISH ALL NOSE PRIORITIES ALLOWING MORE INFORMATION OPT PRIORITIES THEMSELVES, THEY HAVE DEVELOPED AND EXTANT LITERATURE THAT UNDERPINS, SO THAT IS AVAILABLE BUT NOT A REQUIREMENT FOR EACH WORKING GROUP TO BE ABLE TO TAKE ON OR TACKLE. I SUSPECT ALL SIX WORKING GROUPS MAY END UP DEVELOPING THE -- THERE WILL BE SOME CRITICAL PUBLICATIONS THAT FELLOWS HERE IN 2022 OR REALICSICLY 2023 STATE OF THE SCIENCE WITH RESPECT TO EACH SIX PRIMARY TOPICS THAT HAVE BEEN THE THEMES FOR THE DIFFERENT WORKING GROUPS. WE HAVE COVERED A LOT. IN THE LAST COUPLE OF DAYS AND WE WANT TO THANK EVERYONE OF YOU FOR PARTICIPATING IN THE 2022 STOT OF THE SCIENCE TRANSFUSION MEDICINE AND FOR ALL THE COMMENTS AND DIALOGUE EVEN THOUGH THIS VIRTUAL FORMAT IS NEW FOR EXCHANGING SCIENTIFIC IDEAS WE HAVE HAD A FANTASTIC INPUT FROM WORKING GROUP PARTICIPANTS AND PEOPLE WHO PARTICIPATED AS JUST BEING PART OF THIS TWO DAY INTERACTION. AGAIN, THANK YOU ALL VERY MUCH. I ALSO WANT TO THANK DR. NAREG ROUBINIAN FOR BEING CO-CHAIR, DR. GLENN FOR THE SUPPORT FROM THE ORGANIZING COMMITTEE, THE IT STAFF AND EVERYBODY ELSE AT NHLBI, THANK YOU SO MUCH. L WE ARE NOT DONE. WE ARE JUST BEGINNING P DIALOGUE BUT YOU CAN SEE WHAT I PRESENTED ON THE LAST SLIDE WHAT THE NEXT STEPS WILL BE OVER THE COUPLE OF COMING MONTHS. THANK YOU, EVERYBODY.