Transcript Firalis - EUROSFAIRE

Firalis SAS
Biomarker R&D
Bridging Science to Clinics
May 25th 2009
GTN IMI-JU
Hüseyin FIRAT, President, CSO
Firalis at a Glance
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Firalis
Our Mission
Creating novel values in biomarker (BM)-based diagnostics via R&D and
regulatory qualification of BMs
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Focus of Interest
BMs of inflammatory cardiovascular diseases
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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
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President: Hüseyin FIRAT
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Legal Status: SAS founded in July 2008
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Location: Huningue, South-Alsace, proximity of Basel/Switzerland
Firalis proprietary information
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Firalis
Start-up Team
Management team
Jean-Claude Wehrle CEO, from Sept 2009,
Former CEO of NanoVivoDiagnostics Corporation
Hueseyin Firat,
Attila Garami
Fidan Aras
Fuat Firat
Béatrice Molac
Stella Suzan
MD, PhD, Founder President, CSO
MD, PhD, Director of Translational BMs&IA
MD, Responsible for Assay Development
Management, responsible for Financial Affairs
PhD, Director of Regulatory Affairs & PI
PhD, Project Manager
Consultant support:
Denis le Bouteiller MSc, MBA, Management
Brice Suire
Senior Financial Advisor
Joerg Staeheli
DMan, Business Strategy Advisor
IMI-JU service provider
Interface Europe Landry Cochard (Bruxelles)
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Firalis
Servicing Activities
Services offered by Firalis
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Strategy consulting in BM R&D, support establishment of R&D programs, from
design to clinical qualification
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Management of BM R&D, upto the qualification of BMs. A part of experimental work
is subcontracted
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Integrative analysis of data from clinical and/or x-omic BM studies
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Development of BM assays and preclinical/clinical sample testing
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Meso-Scale Discovery Platform
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IMI-JU (Call # 2008.1.5)
Firalis
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
• EMEA1 (as partner) and FDA2 (as advisor)
1European
Medicines Agency
and Drug Administration, USA
3Europeen Federation of Pharmaceutical Industry and Associations
2Food
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IMI-JU (Call # 2008.1.5)
Firalis
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 €
EFPIA3 contribution)
3European
Federation of Pharmaceutical Industry and Associations
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Acknowledgement
Firalis
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)
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