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Biomarker R&D Bridging Science to Clinics May 25 th 2009 GTN IMI-JU Hüseyin FIRAT, President, CSO. Firalis SAS. 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

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Biomarker R&D

Bridging Science to Clinics

May 25th 2009

GTN IMI-JU

Hüseyin FIRAT, President, CSO

Firalis SAS


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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

Firalis proprietary information


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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

Firalis proprietary information


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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 clinicaland/or x-omicBM studies

Development of BM assays and preclinical/clinical sample testing

Meso-Scale Discovery Platform

Firalis

Firalis proprietary information


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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

EMEA1 (as partner) and FDA2 (as advisor)

Firalis

1European Medicines Agency

2Food and Drug Administration, USA

3Europeen Federation of Pharmaceutical Industry and Associations

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Firalis proprietary information


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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 € EFPIA3 contribution)

Firalis

3European Federation of Pharmaceutical Industry and Associations

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Firalis proprietary information


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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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Firalis proprietary information


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