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Firalis SAS Biomarker R&D Bridging Science to Clinics May 25 th 2009 GTN IMI-JU Hüseyin FIRAT, President, CSO
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2 Firalis at a Glance Our Mission Creating novel values in biomarker (BM)-based diagnostics via R&D and regulatory qualification of BMs Focus of Interest BMs of inflammatory cardiovascular diseases Two-pillar business model Servicing activities European contract approved >3 Mio € for 5 years Biomarker R&D activities Companion Diagnostic Test – IP secured Disease Biomarkers – IP secured President: Hüseyin FIRAT Legal Status: SAS founded in July 2008 Location: Huningue, South-Alsace, proximity of Basel/Switzerland Firalis proprietary information Firalis
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3 Start-up Team Management team Jean-Claude WehrleCEO, from Sept 2009, Former CEO of NanoVivoDiagnostics Corporation Hueseyin Firat, MD, PhD, Founder President, CSO Attila GaramiMD, PhD, Director of Translational BMs&IA Fidan ArasMD, Responsible for Assay Development Fuat FiratManagement, responsible for Financial Affairs Béatrice MolacPhD, Director of Regulatory Affairs & PI Stella SuzanPhD, Project Manager Consultant support: Denis le BouteillerMSc, MBA, Management Brice SuireSenior Financial Advisor Joerg StaeheliDMan, Business Strategy Advisor IMI-JU service provider Interface EuropeLandry Cochard (Bruxelles) Firalis proprietary information Firalis
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4 Servicing Activities Services offered by Firalis Strategy consulting in BM R&D, support establishment of R&D programs, from design to clinical qualification Management of BM R&D, upto the qualification of BMs. A part of experimental work is subcontracted Integrative analysis of data from clinical and/or x-omic BM studies Development of BM assays and preclinical/clinical sample testing –Meso-Scale Discovery Platform Firalis proprietary information Firalis
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55 IMI-JU (Call # 2008.1.5) Firalis has created and coordinated the SAFE-T (Safer And Faster Evidence-based Translation) consortium Development of Translational Safety BMs (liver, kidneys and vascular system) Overall foreseen budget: 36 Mio € over 5 years 11 «major pharmas», 4 biotechs, 6 academic EMEA 1 (as partner) and FDA 2 (as advisor) Firalis proprietary information Firalis 1 European Medicines Agency 2 Food and Drug Administration, USA 3 Europeen Federation of Pharmaceutical Industry and Associations
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66 IMI-JU (Call # 2008.1.5) Firalis is a major contributor to SAFE-T Initiator of the SAFE-T project and coordinator of applicant consortium Co-leading with the Industry partners 4 out of 9 Work Packages Obtained the highest EU funding among all partners Unique SME within the vascular project (budget:12 Mio €, 7 Mio € EFPIA 3 contribution) Firalis proprietary information Firalis 3 European Federation of Pharmaceutical Industry and Associations
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7 Firalis proprietary information 7 Acknowledgement Firalis team acknowledges for their support Regional institutions Agence Régional de l’Innovation (JJ Bernardini) SEMIA, OSEO Alsace, Alsace Innovation, Alsace Biovalley Philippe ARHETS (INSERM) IMI-JU service provider Interface Europe, Bruxelles (Landry Cochard) Firalis
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