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Blood Safety Is Pleased to Invite You to Its SYMPOSIUM

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Blood Safety Is Pleased to Invite You to Its SYMPOSIUM Macopharma Lead the way in blood safety is pleased to invite you to its SYMPOSIUM BLOOD SAFETY Tuesday, June 5th 2018 www.bloodsafety.macopharma.com ISBT Toronto 2018 BLOOD SAFETY ISBT Toronto 2018 Tuesday, June 5th 2018 12.00 - 1.30 PM Room 718 B Chairperson Prof. Dana Devine CBS, Vancouver Presentations « THERAFLEX UV-Platelets: Mechanism of action, specifications and sterility studies » Prof. Axel Seltsam (DRK, Springe) « The phase III CAPTURE Trial: routine use in the blood bank of Frankfurt » Dr. Veronika Brixner (DRK, Frankfurt) « Review on the inactivation of arboviruses with THERAFLEX» Prof. Denese Marks (ARCBS, Sydney) 2 BLOOD SAFETY SYMPOSIUM BLOOD SAFETY SYMPOSIUM 3 PROF. DANA DEVINE Chairperson Selected publications: Chief Scientist, Canadian Blood Services Devine DV. Pathogen Inactivation strategies to improve blood safety: let’s not throw pathogen-reduced platelets out with their bath water. JAMA Oncol, 2018; 1. DOI: 10.1001/jamaoncol.2017.4949 Professor of Pathology & Laboratory Medicine, Goldman M, W-Y Shih A, O’Brien SF, Devine D. Donor deferral policies for men who have sex with men: past, present and University of British Columbia, Vancouver, Canada future. Vox Sang 2018; 113(2):95-103. Germain M, Delage G, O’Brien SF, Grégoire Y, Fearon M, Devine D. Mitigation of the threat posed to transfusion by donors traveling to Zika-affected areas: a Canadian risk-based approach. Transfusion 2017; 57(10):2463-2468. EMPLOYMENT HISTORY Devine DV. Implementation of pathogen inactivation technology: how to make the best decisions? Transfusion 2017; 57(5):1109-1111. 2018 - present: Chief Scientist Klein-Bosgoed C, Schubert P, Devine DV. Riboflavin and ultraviolet illumination affects selected platelet mRNA transcript Canadian Blood Services amounts differently. Transfusion 2016; 56(9):2286-95. 2000 - present: Professor of Pathology & Laboratory Medicine Schubert P, Culibrk B, Karwal S, Serrano K, Levin E, Bu D, Bhakta V, Sheffield WP, Goodrich RP, Devine DV. Whole blood University of British Columbia, Vancouver, Canada treated with riboflavin and ultraviolet light: quality assessment of all blood components produced by the buffy coat method. Transfusion 2015; 55(4):815-23. 2006 – 2017: Chief Medical & Scientific Officer Canadian Blood Services Schubert P, Coupland D, Culibrk B, Goodrich RP, Devine DV. Riboflavin and ultraviolet light treatment of platelets triggers p38MAPK signaling: inhibition significantly improves in vitro platelet quality after pathogen reduction treatment. Transfusion 2013; 53(12):3164-73. 1995 - 2000: Associate Professor of Pathology & Laboratory Medicine University of British Columbia, Vancouver, Canada Semple E, Bowes-Schmidt A, Yi QL, Shimla S, Devine DV. Transfusion reactions: a comparative observational study of blood CURRICULUM VITAE CURRICULUM components produced before and after implementation of semiautomated production from whole blood. Transfusion 1999 – 2006: Director, Research & Development 2012; 52(12):2683-91. Canadian Blood Services Stein J, Besley J, Brook C, Hamill M, Klein E, Krewski D, Murphy G, Richardson M, Sirna J, Skinner M, Steiner R, van Aken P, Devine D. Risk-based decision-making for blood safety: preliminary report of a consensus conference. Vox Sang 2011; 101(4):277-81. EDUCATION Kleinman S, Cameron C, Custer B, Busch M, Katz L, Kralj B, Matheson I, Murphy K, Preiksaitis J, Devine D. Modeling the risk 1987 : PhD (Immunology) of an emerging pathogen entering the Canadian blood supply. Transfusion 2010; 50(12):2592-606. Duke University, Durham, North Carolina, USA 4 BLOOD SAFETY SYMPOSIUM BLOOD SAFETY SYMPOSIUM 5 PROF. AXEL SELTSAM Prof. Axel Seltsam « THERAFLEX UV-Platelets: Mechanism of action, specifications Speaker and sterility studies » « THERAFLEX UV-Platelets: Mechanism of action, specifications and sterility studies » THERAFLEX UV-PLATELETS: AN UPDATE ON THE CLINICAL DEVELOPMENT Associate Professor for Transfusion Medicine, Hanover Medical School, Germany In line with current microbial risk reduction efforts, pathogen inactivation (PI) technologies for Head of production and head of R&D, blood components promise to reduce the residual risk of known and emerging infectious German Red Cross Blood Service NSTOB, Springe agents. THERAFLEX UV-Platelets is a novel UVC-based PI technology for treatment of platelet concentrates (PCs) that works without photoactive substances. It is the product of a joint venture between Macopharma and the German Red Cross Blood Service NSTOB in EMPLOYMENT HISTORY Springe, Germany. Shortwave UVC light (254 nm) directly interacts with nucleic acids to form pyrimidine dimers that block the elongation of nucleic acid. UVC irradiation mainly 2008 - present: Head of production and head of R&D affects the nucleic acids of pathogens and leukocytes and does not impair plasma and German Red Cross Blood Service NSTOB, Springe platelet quality. The THERAFLEX UV-Platelets system effectively inactivates a broad range of 2003 - 2008: Associate Professor for Molecular Immunohaematology different disease-causing viruses, bacteria and protozoa. As no photoactive substances are Institute of Transfusion Medicine, Hannover Medical School, Germany involved, UVC treatment is just as simple but faster (takes less than 1 minute) than gamma irradiation, and can easily be integrated into the manufacturing processes at blood banks. 2001 - 2003: Resident physician and scientific assistant Institute of Transfusion Medicine, Hannover Medical School, Germany The THERAFLEX UV-Platelets system is currently under clinical investigation in a multicenter 1998 - 2001: Scientific assistant trial in Germany. This phase III, randomized, controlled, double blind study, called CAPTURE, Institute of Transfusion Medicine, University Hospital Charité investigates the clinically effectiveness and safety of UVC-treated PCs in comparison to Berlin, Germany CURRICULUM VITAE CURRICULUM conventional (non-UVC-treated) PCs. Both, buffy-coat-derived pool PCs and apheresis PCs 1996 - 1998: Junior physician stored for up to 5 days in platelet additive solution (SSP+), are used in the study. Medical Clinic I of the Clinical Centre Fürth, teaching hospital Hematology-oncology patients with thrombocytopenia are randomly assigned to receive of the Friedrich-Alexander University Erlangen-Nuremberg prophylactic and therapeutic transfusions (either UVC-treated or control platelets). Primary endpoint of the study is 1-hour corrected count increment (CCI). Secondary endpoints EDUCATION include efficacy-related parameters (24-hour CCI, 1-hour and 24-hour CCIs, transfusion 2010: Master of Health Business Administration (MHBA) requirement of red cells and platelets, platelet transfusion interval) and safety parameters Friedrich-Alexander University Erlangen-Nuremberg, Germany (e.g., severe bleeding and platelet refractoriness). The ongoing study started in 2016. Patients will be enrolled up to a maximum of 166 patients. 2002: Specialist in Transfusion Medicine 1996: Doctor of Medicine Friedrich-Alexander Univer sity Erlangen-Nuremberg, Germany 6 BLOOD SAFETY SYMPOSIUM BLOOD SAFETY SYMPOSIUM 7 DR. VERONIKA BRIXNER Speaker Selected publications: Kim S, Handke W, Gravemann U, Döscher A, Brixner V, Müller TH, Seltsam A. Mitochondrial DNA multiplex real-time «The phase III CAPTURE Trial: routine use in the blood bank of Frankfurt » polymerase chain reaction inhibition assay for quality control of pathogen inactivation by ultraviolet C light in platelet concentrates. Transfusion 2018; 58:758-65. Van der Meer PF, Gravemann U, de Korte D, Sumian C, Tolksdorf F, Müller TH, Seltsam A. Effect of increased agitation Head of production speed on pathogen inactivation efficacy and in vitro quality in UVC-treated platelet concentrates. Vox Sang 2016; German Red Cross Blood Service Baden-Württemberg - Hesse, Frankfurt 111:127-34. Faddy HM, Fryk JJ, Prow NA, Watterson D, Young PR, Hall RA, Tolksdorf F, Sumian C, Gravemann U, Seltsam A, Marks DC. Inactivation of dengue, chikungunya, and Ross River viruses in platelet concentrates after treatment with ultraviolet C light. Transfusion 2016; 56:1548-55. EMPLOYMENT HISTORY Thiele T, Pohler P, Kohlmann T, Sumnig A, Aurich K, Selleng K, Westphal A, Bakchoul T, Petersmann A, Muller TH, Greinacher A, Seltsam A. Tolerance of platelet concentrates treated with UVC-light only for pathogen reduction - a phase I clinical 2017 - present: Head of production trial. Vox Sang 2015; 109:44-51. German Red Cross Blood Service Baden-Württemberg - Hesse, Frankfurt Pohler P, Müller M, Winkler C, Schaudien D, Sewald K, Müller TH, Seltsam A. Pathogen reduction by ultraviolet C light effectively inactivates human white blood cells in platelet products. Transfusion 2015; 55:337-47. 2002 – 2010: Resident physician and scientific assistant German Red Cross Blood Service Baden-Württemberg - Hesse, Frankfurt Seltsam A, Muller TH. Br J. Update on the use of pathogen-reduced human plasma and platelet concentrates. Haematol 2013; 162:442-54. 2000 – 2001: Junior physician Medical Clinic I of the St. Josefs Hospital Wiesbaden, teaching hospital Bashir S, Cookson P, Wiltshire M, Hawkins L, Sonoda L, Thomas S, Seltsam A, Tolksdorf F, Williamson LM, Cardigan R. of the Johann-Wolfgang Goethe University, Frankfurt, Germany Pathogen inactivation of platelets using ultraviolet C light: effect on in vitro function and recovery and survival of platelets. Transfusion 2013; 53:990-1000. EDUCATION Steinmann E, Gravemann U, Friesland M, Doerrbecker J, Muller TH, Pietschmann T, Seltsam A. Two pathogen reduction VITAE
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