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The unique immune
 monitoring service
center for your drug
   development



                www.cimna.org
Immunomonitoring for drug development

   Immune response analysis:
    a real added value to strengthen your pipeline

     Regulatory environment
       New requirements of EMEA and FDA for a better understanding of:
       • drug mechanisms of action
       • scientific context
       • initial drug dose evaluation

     Industrial environment
        • Obtain necessary information for GO/NO GO decisions
        • Strategic discovery of Biomarkers



                                                                www.cimna.org
CIMNA unique integrated Immunomonitoring center


   CIMNA is a niche service provider specialized in
    immunology

   We offer an access to a high-quality one-stop shop:

     EXPERTISE (board of experts in Immunology)
     State of the Art Technologies
     QUALITY Services
     Project Management


                                                www.cimna.org
CIMNA organisation

1300sqm of Laboratories, +60 employees, 1 location (Nantes, France)




                                                          www.cimna.org
Scientific Committee

   A high-level scientific committee ensuring best adequacy and
    interpretation of information for the specific needs of our partners

     Chairman: Prof. Régis JOSIEN

     TECHNOLOGY EXPERTS
        •   Cytomics:             Dr. Marie RIMBERT
        •   Transcriptomics :     Dr. Rémi HOULGATTE
        •   Repertoire:           Dr. Marina GUILLET
        •   Statistics:           Dr. Nadine GODFROID

     EXPERTS BY THERAPEUTIC AREA
        •   Transplantation :             Prof. Jean-Paul SOULILLOU
        •   Autoimmunity/inflammation:    Prof. Mohamed HAMIDOU
        •   Oncology & Immunotherapy:     Prof. Marc BONNEVILLE
        •   Neuroimmunology:              Dr. David LAPLAUD
        •   Allergy:                      Prof. Antoine MAGNANT
                                                               www.cimna.org
Cytomic unit

   ELISPOT
        • antigen-specific cytokine-secreting T cells (vaccin
          development, autoimmunity, infectious disease, cancer,
          transplantation)                                               GBEA
        • antigen-specific CTL
        • antigen-specific antibody producing B cells
   POLYCHROMATIC FLOW CYTOMETRY
        • immune cells (T, B, NK, DC, Mono.)
        • T cell subsets (naive, effector, central memory, effector
          memory)
        • Counting of antigen-specific T cells with tetramers
        • Intracellular cytokine staining to assess T cell function
   MULTIPLEX BEAD ARRAY ASSAYS
        • Multiple cytokine/chemokine quantification (immune
          response, inflammation, cytokine storm, etc..).
        • Multiple auto-antibody titration
   ELISA
        • Cytokine/chemokine dosage
        • Immunoglobulin dosage
        • Auto-antibody detection and titration
                                                                       www.cimna.org
T cell repertoire & qPCR unit
   TcLandscape
         • Transcriptomic approach to the analysis of T cell receptor
           populations.
         • Qualitative analysis of the TCR Vb Gene usage and CDR3         ISO
           Length distribution combined with qPCR on TCR mRNA            17025
           transcripts

   Indications:
         • Immune response detection & characterization
         • Targeting immune populations for functional analyses
         • Improvements in understanding disease
         • Screening drug candidates for their effect on T cell
           mobilization
         • Diversity analysis (Epitope spreading, Clonality testing)
         • Potential beneficial activity in animal models

   T Cell mobilization signature

   qPCR unit
         • Customized service using our real-time PCR platform (ABI
           7900HT)
         • ISO 17025 compliant
         • Easy and rapid transfer of your protocol to ISO 17025        www.cimna.org
Transcriptomics Unit
           Microarrays services
             DNA Chip (Agilent, Affimetrix)           ISO
                                                      9001
             miRNA expression
             SNP genotyping
             BioInformatics & biostatistics (21CFR part11)


                                       Clinical operations Unit
   Methodology
   Regulations
   CO, Monitoring
   Data Management                  GCP
   Biostatistics
   Medical writing
   Web Randomization
                                                    www.cimna.org
The unique immune
 monitoring service
      center



               www.cimna.org

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Cimna Slide Show October 2009

  • 1. The unique immune monitoring service center for your drug development www.cimna.org
  • 2. Immunomonitoring for drug development  Immune response analysis: a real added value to strengthen your pipeline  Regulatory environment New requirements of EMEA and FDA for a better understanding of: • drug mechanisms of action • scientific context • initial drug dose evaluation  Industrial environment • Obtain necessary information for GO/NO GO decisions • Strategic discovery of Biomarkers www.cimna.org
  • 3. CIMNA unique integrated Immunomonitoring center  CIMNA is a niche service provider specialized in immunology  We offer an access to a high-quality one-stop shop:  EXPERTISE (board of experts in Immunology)  State of the Art Technologies  QUALITY Services  Project Management www.cimna.org
  • 4. CIMNA organisation 1300sqm of Laboratories, +60 employees, 1 location (Nantes, France) www.cimna.org
  • 5. Scientific Committee  A high-level scientific committee ensuring best adequacy and interpretation of information for the specific needs of our partners  Chairman: Prof. Régis JOSIEN  TECHNOLOGY EXPERTS • Cytomics: Dr. Marie RIMBERT • Transcriptomics : Dr. Rémi HOULGATTE • Repertoire: Dr. Marina GUILLET • Statistics: Dr. Nadine GODFROID  EXPERTS BY THERAPEUTIC AREA • Transplantation : Prof. Jean-Paul SOULILLOU • Autoimmunity/inflammation: Prof. Mohamed HAMIDOU • Oncology & Immunotherapy: Prof. Marc BONNEVILLE • Neuroimmunology: Dr. David LAPLAUD • Allergy: Prof. Antoine MAGNANT www.cimna.org
  • 6. Cytomic unit  ELISPOT • antigen-specific cytokine-secreting T cells (vaccin development, autoimmunity, infectious disease, cancer, transplantation) GBEA • antigen-specific CTL • antigen-specific antibody producing B cells  POLYCHROMATIC FLOW CYTOMETRY • immune cells (T, B, NK, DC, Mono.) • T cell subsets (naive, effector, central memory, effector memory) • Counting of antigen-specific T cells with tetramers • Intracellular cytokine staining to assess T cell function  MULTIPLEX BEAD ARRAY ASSAYS • Multiple cytokine/chemokine quantification (immune response, inflammation, cytokine storm, etc..). • Multiple auto-antibody titration  ELISA • Cytokine/chemokine dosage • Immunoglobulin dosage • Auto-antibody detection and titration www.cimna.org
  • 7. T cell repertoire & qPCR unit  TcLandscape • Transcriptomic approach to the analysis of T cell receptor populations. • Qualitative analysis of the TCR Vb Gene usage and CDR3 ISO Length distribution combined with qPCR on TCR mRNA 17025 transcripts  Indications: • Immune response detection & characterization • Targeting immune populations for functional analyses • Improvements in understanding disease • Screening drug candidates for their effect on T cell mobilization • Diversity analysis (Epitope spreading, Clonality testing) • Potential beneficial activity in animal models  T Cell mobilization signature  qPCR unit • Customized service using our real-time PCR platform (ABI 7900HT) • ISO 17025 compliant • Easy and rapid transfer of your protocol to ISO 17025 www.cimna.org
  • 8. Transcriptomics Unit  Microarrays services  DNA Chip (Agilent, Affimetrix) ISO 9001  miRNA expression  SNP genotyping  BioInformatics & biostatistics (21CFR part11) Clinical operations Unit  Methodology  Regulations  CO, Monitoring  Data Management GCP  Biostatistics  Medical writing  Web Randomization www.cimna.org
  • 9. The unique immune monitoring service center www.cimna.org