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