Translational Sciences Division

Designed by Drug Developers, Run by Drug Developers

Your dedicated Strategic and Scientific Drug Development Partner from Bench to Bedside

  • Translational Strategy
    • Drug Development Biomarker Strategies: Preclinical to Filing

       

    • Post-market Clinical Research Strategy

       

    • Large Molecule Bioanalytical Strategy

       

    • Bioanalytical and Biomarker Assay Life Cycle Management

       

  • Scientific Partnership
    • Scientific Guidance and Oversight of PK, Immunogenicity, and Biomarker Projects

       

    • Data Analysis and Interpretation

       

    • Scientific Integration with drug development stakeholders

       

    • Critical Reagent Design and Management

       

  • Regulatory Engagement
    • Author and Review Bioanalytical and Biomarker sections for INDs, study protocols & reports, & filing documents

       

    • Regulatory Q&A

       

    • Data-driven Influencing of Regulatory Guidance

       

Immunologix Laboratories - Facility

Synergizing with Immunologix Laboratories Assay Experts

Recognized experts in Ligand Binding Assays

Preclinical and Clinical PK, Immunogenicity, and Biomarker Assay Development, Validation, & Study Analyses

Critical Reagent Characterization Services