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HIP Symposium 34

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REGENERATIVE MEDICINE FOR COVIDJuly 14, 202112:00-2:00pmH O P E O R H Y P E ?Healthcare Innovation Symposium XXXIV

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12:00-12:05 pm12:05-12:25 pm12:25-12:45 pm1:00-1:10 pm1:10-1:20 pm 1:20-1:30 pmWELCOME AND INTRODUCTIONSREGENERATIVE MEDICINE FOR COVID THERAPYPOTENTIAL NEW THERAPIESCHARACTERIZATION & MANUFACTURINGCELL THERAPY AT EMORY - POTENTIAL FOR COVIDEXPERIENCE & EXPECTATIONSJoanne Kurtzberg, MDJerome Harris Distinguished Professor of Pediatrics and Professor of PathologyDirector, Marcus Center for Cellular CuresDirector, Pediatric Blood and Marrow Transplant ProgramDuke University Medical CenterFred Sanfilippo MD, PhDDirector, Emory-Georgia Tech Healthcare Innovation ProgramProfessor of Pathology & Laboratory Medicine, Emory University School of MedicineProfessor of Health Policy & Management, Rollins School of Public Health Joshua Hare, MDChief Sciences OfficerSenior Associate Dean for Experimental and Regenerative TherapeuticsLouis Lemberg Professor of MedicineDirector, Interdisciplinary Stem Cell InstituteUniversity of Miami Miller School of MedicineEd Waller, MD, PhDProfessor of Medicine, Medical Oncology and PathologyRein Saral MD Professorship in Cancer MedicineDirector, Emory Regenerative Engineering and Medicine CenterMedical Director, Center for Stem Cell Processing and ApheresisEditor-in-Chief, Journal of ImmunoMedicineEmory University School of MedicineSteve Stice , PhDDW Brooks Distinguished ProfessorDirector, Regenerative Bioscience CenterUniversity of GeorgiaChief Scientific Officer, Aruna Bio Inc.Krish Roy, PhDRobert A. Milton Chair ProfessorDirector, NSF Engineering Research Center (ERC) for Cell Manufacturing Technologies (CMaT)Director, Marcus Center for Therapeutic Cell Characterization and Manufacturing (MC3M)Director, Center for ImmunoEngineeringThe Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and EmoryProgram1:30-2:00 pmQ&A SESSION

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Joanne Kurtzbereg, MDMarcus Center for Cellular CuresDuke UniversityDr. Kurtzberg is an internationally renownedexpert in pediatric hematology/oncology,pediatric blood and marrow transplantation,umbilical cord blood banking andtransplantation, and novel applications of cordblood in the emerging fields of cellulartherapies and regenerative medicine. Dr.Kurtzberg serves as the Director of the MarcusCenter for Cellular Cures (MC3), Director of thePediatric Blood and Marrow TransplantProgram, Director of the Carolinas Cord BloodBank, and Co-Director of the Stem CellTransplant Laboratory at Duke University. Dr. Kurtzberg’s research in MC3 focuses ontranslational studies from bench to bedside,seeking to develop transformative clinicaltherapies using cells, tissues, molecules, genes,and biomaterials to treat diseases and injuriesthat currently lack effective treatments. Recentareas of investigation in MC3, which are fundedby the Marcus Foundation, include the use ofautologous cord blood in children withneonatal brain injury, cerebral palsy, andautism, as well as preclinical studiesmanufacturing microglial oligodendrocyte-likecells from cord blood to treat patients withacquired and genetic brain diseases. Studies ofdonor cord blood cells in adults with strokeand children with cerebral palsy and autismare also underway. Dr. Kurtzberg’s lab has developed novelchemotherapeutic drugs for T-cellLeukemias, assays enumerating ALDH brightcells to predict cord blood potency fromsegments attached to cryopreserved cordblood units, and is performing translationalresearch testing cord blood expansion,cellular targeted therapies and tissue repairand regeneration. Dr. Kurtzberg currentlyholds several INDs for investigational clinicaltrials.

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Joshua Hare, MDInterdisciplinary Stem Cell InstituteUniversity of MiamiJoshua Hare is Chief Sciences Officer, SeniorAssociate Dean for Experimental and CellularTherapeutics, Director of the InterdisciplinaryStem Cell Institute (ISCI), and Louis LembergProfessor of Medicine at the University ofMiami Miller School of Medicine. Dr. Hare is apracticing cardiologist specializing in heartfailure, and an internationally acknowledgedpioneer in the field of stem cell therapeuticsfor human heart disease. Dr. Hare led the first randomized allogeneicmesenchymal stromal cell (MSC) clinical trialfor patients with myocardial infarction and hasserved as Principal Investigator of three majorNHLBI programs in cell-based therapy. Heholds 27 active INDs for cell-based therapy,and under his leadership ISCI has activeprograms in cancer biology, cardiology, aging,neonatology, skin diseases, bone diseases,neurologic diseases, ophthalmology, and aprogram devoted to the ethics of stem celltherapy. Dr. Hare has published more than 350 originalresearch articles, editorials, and reviewarticles, and is the recipient of four activegrants from the NIH. He has served in the pastas chair of the Cardiac Contractility and HeartFailure study section of the NIH, and chairedStem Cell Working Group and BasicCardiovascular Science Council of theAmerican Heart Association. Educated at the University of Pennsylvania,Johns Hopkins, Brigham and Women’sHospital, and Harvard Medical School, Dr.Hare spent 12 years on the faculty at JohnsHopkins rising to the rank of Professor ofMedicine and Biomedical Engineering, andDirector of the Cardiac Transplant and HeartFailure program before joining the Universityof Miami in 2007. Dr. Hare is an electedmember of the American Association ofPhysicians and the Association of UniversityCardiologists. He is the inventor of 15 UnitedStates patents, that have led to the foundingof four biotechnology companies.

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Edmund Waller, MD, PhD Emory Regenerative Engineering and Medicine CenterEmory UniversityDr. Waller completed his undergraduatedegree at Harvard University in 1978, hisMD-PhD degree at Cornell UniversityMedical School and Rockefeller University in1985, and his clinical training in Oncology atStanford University in 1991. As a post-doctoral Fellow at Stanford from 1991 -1993, he studied hematopoiesis with Dr.Irving Weissman. Dr. Waller was recruited toEmory University in 1994 and promoted to atenured Professor of Hematology andMedical Oncology, Medicine, and Pathologyat Emory University in 2005. He served asthe Associate Director for Clinical Researchfor the Emory Winship Cancer Center from2009-2012 and as the Director of the BoneMarrow and Stem Cell Transplant Programat Emory University from 1998 to 2019. Hecurrently serves as the Emory Director forRegenerative Medicine and Engineering. Dr.Waller’s research is funded by the NationalCancer Institute, National Heart Lung andBlood Institute as well as the NationalMarrow Donor Program. Dr. Waller is the author of over 330 peer-reviewed articles with an h-index of 56. Dr.Waller’s research focuses on optimizing anti-cancer immunity. He has developed novelstrategies of regulating immune responsesby studying the interaction between T cellsand dendritic cells in murine models andusing clinical samples from patients. Currentprojects in his laboratory include graft engineering to enhance graft versusleukemia activities and post-transplantimmune reconstitution, novel drugsthat target immune pathways toregulate graft-versus-host disease, anddrugs that activate and expandcancer-specific T cells. He is thePrincipal Investigator of an IND-supported randomized placebo-controlled clinical trial of duvelisib, animmune-modulatory phosphatidylinositol-3 kinase inhibitor in patientswith severe COVID-19.

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Dr. Steve Stice is a Georgia Research AllianceEminent Scholar endowed chair, Professor andDirector of the Regenerative Bioscience Center atThe University of Georgia and serves as ChiefScientific Officer for ArunA Biomedical Inc. Dr. Sticeco-founded five biotechnology companies,including Advanced Cell Technology, andCytoGenesis, Inc., which was later purchased byBresaGen. Dr. Stice helped BresaGen develop four of thehuman embryonic stem cell lines approved for NIHfunding. He produced the first cloned rabbit in1987 and the first cloned transgenic calves, Georgeand Charlie, in 1988. In 1997, he produced the firstgenetically modified embryonic stem cell derivedpigs and cattle. In 2001, he announced abreakthrough in the cloning process and the firstcloned animal (calf) from an animal that was deadfor 48 hours. Stice continues to add to his first-to-market innovations. Working in collaboration withhis startup, ArunA and RBC researchers, he iscurrently developing a new Exosome treatment forstroke that has shown to reduce brain damage andaccelerate the brain's natural healing tendencies, intwo divergent animal species and two stroke types.Dr. Stice holds thirty-one patents, his most recenton neural stem cell-derived Exosome treatments topromote brain repair after stroke or TBI. As an invited member, he sits on the ScientificAdvisory Board for the Food and DrugAdministration (FDA), and is serving on theGoverning Committee of the first institute fundedby the U.S. Department of Commerce (DOC);National Institute for Innovation in ManufacturingBiopharmaceuticals (NIIMBL). Dr. Stice was named one of the 100 MostInfluential Georgians in 2002 by Georgia Trendmagazine. In 2000, he was named one of the topforty entrepreneurs under forty years old in Steven Stice, PhDRegenerative Bioscience CenterUniversity of GeorgiaGeorgia, and he received the AGR grandpresident’s award for leadership inagriculture and the Outstanding YoungAlumni Award from the University ofIllinois. In 2015 he was presented asAcademic Entrepreneur of the Year.Most recent honors include 2018election Fellow status to The NationalAcademy of Inventors® (NAI), thehighest professional distinctionaccorded solely to academic inventors,and the 2017 Georgia Bio IndustryGrowth Award, the most recognizedhonor bestowed by Georgia Bio, thestate’s life science advocacy andbusiness association. Dr. Stice received a B.S. degree inAgricultural Science from the Universityof Illinois in 1983, an M.S. degree in1985 from Iowa State University, and aPh.D. in 1989 from the University ofMassachusetts in Amherst.

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Dr. Krishnendu (Krish) Roy is the Robert A.Milton Chaired Professor in BiomedicalEngineering. At Georgia Tech, he also serves asthe Director of the newly established NSFEngineering Research Center for CellManufacturing Technologies and The MarcusCenter for Cell-Therapy Characterization andManufacturing - as well as the Director of theCenter for ImmunoEngineering. He is also theTechnical Lead of the NIST/AMTech National CellManufacturing Consortium, a national public-private partnership, focused on addressing thechallenges and solutions for large scalemanufacturing of therapeutic cells. Dr. Roy’sresearch interests are in the areas of scalablecell manufacturing, Immuno-engineering, stem-cell engineering and controlled drug andvaccine delivery technologies, with particularfocus in biomedical materials. In recognition of his seminal contributions tothese fields, Dr. Roy is elected Fellow of theAmerican Institute for Medical and BiologicalEngineering and the Biomedical EngineeringSociety. In addition, Dr. Roy has receivednumerous awards and honors including YoungInvestigator Awards from both the ControlledRelease Society and The Society forBiomaterials, NSF CAREER award, Global IndusTechnovator Award from MIT, the CRS CygnusAward etc. He is also the recipient of BestTeacher Award given by the BiomedicalEngineering Students at UT-Austin and the bestadvisor award given by bioengineering studentsat Georgia Tech.Krish Roy, PhDWallace H. Coulter Dept. of Biomedical Engineering Georgia Institute of TechnologyHe serves as a member of the EditorialBoards of the Journal of ControlledRelease, the European Journal ofPharmaceutics and Biopharmaceutics,the Journal of Immunology andRegenerative Medicine, all fromElsevier, as well as the AIChE Journal ofAdvanced Biomanufacturing andBioprocessing. He is a member of theForum on Regenerative Medicine of theNational Academies of Science,Engineering and Medicine (NASEM),and a Board Member of the StandardsCoordinating Body (SCB) for Cell andRegenerative Therapies.

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Fred Sanfilippo, MD, PhD directs the Emory-Georgia Tech Healthcare Innovation Program,which has a mission to accelerate innovationin healthcare research, education, andservice. He also serves as Professor ofPathology and Laboratory Medicine andHealth Policy and Management at Emory, andformer Medical Director of the MarcusFoundation. For over 30 years he has been anacademic leader at Duke, Johns Hopkins, OhioState and Emory; serving as a division chief,department chair, program/center director,dean, medical center CEO, universitysenior/executive VP, health system boardchair and academic health center CEO.During that time he has led organizationaland cultural changes yielding improvedacademic, clinical, and financial performanceat each institution. He also led the creation ofthe US Scientific Registry of TransplantRecipients; Johns Hopkins Medical Labs; apersonalized health plan (YP4H) at OSU; andnovel departments and centers in areasranging from Biomedical Informatics toPersonalized Health and Integrative Medicine. Sanfilippo received his BA and MS in physicsfrom the University of Pennsylvania, and hisMD and PhD in immunology from Duke,where he also did his residency training,receiving board certification in Anatomic &Clinical Pathology, and Immunopathology. Fred Sanfilippo, MD, PhDEmory-Georgia Tech Healthcare Innovation ProgramEmory UniversityHe has mentored more than 30 graduate student and fellows, servedon 13 editorial boards, publishedover 250 articles, received threepatents, and been awarded over $30million in sponsored research. He hasbeen board chair of five non-profits,and president of seven academic andprofessional organizations includingthe American Society of InvestigativePathology and the American Societyof Transplantation.

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