Specialized Workshop Th1 - Thursday April 10, 2025: 7am to 5:30pm - Discussion Topic List

" Ligand-Binding Assays - Latest Advances, Challenges and Solutions from Internationally Recognized Key Opinion Leaders"

Understanding the Challenges of LBA Applications to Novel Modalities; Advanced/Innovative Applications of Automation/Robotic, Machine Learning, DOE in LBA Development; Strategies & Novel Case Studies for Complex Method Development for Next-Generation of Antibody-Based Therapeutics, Multispecifics/Complex Biotherapeutics, Drug Conjugates, Biomarkers, ADA/Nab; Cutting-Edge Advancements in LBA Critical Reagents/Positive Controls Generation and Performance Evaluation for Biotherapeutics, Gene Therapy and Biomarkers Application; Latest Advances in the Method Development/Validation for Enzymatic Assays and Long-Term Maintenance to Support Gene Therapy; Innovative Approaches for Bridging Highly Variable Critical Reagents Lots; Understanding the Unique Challenges of Critical Reagent Generated for Novel Modalities and for Emerging Technologies; Application of Discovery Bioanalysis Solution to Regulated Bioanalysis; AND LASTLY, WRIB Traditional KOL Industry/Regulators Focused and Highly Interactive Panel Discussions on Discovery/Regulated Ligand-Binding & Enzymatic Assays Applications and Recent Controversial Issues

Session 1: LBA in Gene Therapy: Innovative Approaches in LBA for Total Antibody/Neutralizing Antibody (TAb/NAb) Assays Supporting GT Trials

Session 2: LBA in Immunogenicity: Super Sensitive ADA/NAb LBA, Strategies on ADA LBA Formats and Singlicate Validation

Session 3: LBA Critical Reagents: Enhanced Approaches for Characterization of CR/PC for Biomarker & ADA/NAb Assays

Session 4: State-of-the-art Integrative Bioanalysis by Leveraging Multiple Platforms: LBA, Mass Spec and PCR

Session 5: 2024 White Paper in Bioanalysis

  • 2024 White Paper on Ligand-Binding Assays - Latest Advances, Challenges and Solutions from Internationally Recognized Key Opinion Leaders

    Consensus & Conclusions on Ligand-Binding Assays - Latest Advances, Challenges and Solutions from Internationally Recognized Key Opinion Leaders for 2024 White Paper





Agenda at a Glance Agenda at a Glance