Specialized Workshop Th1 - Thursday June 22, 2023: 7am to 5:30pm - Discussion Topic List

"Ligand Binding Assays - Latest Developments, Challenges, and Solutions"

NEW Case Studies on Tissue LBA, Enzyme Assays and Multiplexing Innovative Approaches and Technology Advancements; Method Development Strategies for MDBs, Oligonucleotides, ADCs, and Cytokine Drugs; LBA Singlicate application for PK, ADA, NAb Assays; Critical Reagents for New Modalities Development/Strategies; Recombinant Calibrators for LBA, Non-Animal-Based Critical Reagents and Implementation of Hybridoma Phage Display; Recent Discovery Bioanalysis Solution and How to Transfer them to Regulated Bioanalysis

Session 1: Emerging & Multiplexing Technologies in Bioanalysis and Advancements in Enzyme Assays

  • Topic 1:

    Enzyme Activity Assay Development/Validation for Gene Therapy: Recent Developments, Updated Recommendations, Fit for Purpose Validation Strategy for Enzyme Assay in Serum & Tissue for the Transgene Protein, Importance to provide the Functional Readout after Cell Infection/Transduction, Evaluation of Assay Performance
    Dr. Hiroshi Sugimoto, Associate Director, Takeda

  • Topic 2:

    Tape Stripping Sample Collection: A Non-Invasive Method for Studying Target of Interest Expressed in the Skin, Tape Stripping Advantages vs Skin Biopsies current Invasive Gold Standard, Multiplex Assay and Buffer Optimization for Protein Extraction and Quantitation of Stratum Corneum Biomarkers
    Dr. Carolina Owen, Lab Head Ligand Binding Assays, Pfizer

  • Topic 3:

    Evaluation of Multiplexing Technologies for Targeted Proteomics: Evaluation of Olink, Somalogics, Luminex, Benefit of Measuring many Proteins Simultaneously, Issues with Panels with Poor Quality Data and Needs for Additional Assays with Better Sensitivity, Strategy for picking QC Levels, Best Technologies for Higher Plex/Panels 
    Dr. LaKenya Williams, Associate Director, BMS

  • Topic 4:

    Innovative Olink & Simoa Application in Bioanalysis - Exploring Emerging Technologies for Solving Challenging LBA Methodologies, High Multiplex/Throughput platform Olink, Understanding the Potentials/Limitations on Biomarker Analysis, Nanomolar to Sub Picomolar Analysis for PK Assay, Simoa applications beyond Biomarkers
    Dr. Tao Xu, Associate Director, Frontage

Session 2: Novel Modalities Method Development/Validation Challenges

  • Topic 5:

    Multi-Domain Biologics Advanced Bioanalytical Strategies: Answering Domain-specific Questions about Bioanalysis of Conditionally Activated Biologics, Strategies for Adapting LBA Methodologies to Distinguish Intact or Cleaved Products, Integrating Bioanalytical Approaches from Diverse Assay Formats
    Dr. Samuel Pine, Global Head of Bioanalysis & Immunogenicity, DMPK, Sanofi

  • Topic 6:

    Bioanalytical Strategies for Highly Complex Masked Cytokine Drugs: Best Practices and Approaches for this Novel Class of Drugs, Understanding the Bioanalysis of these MDB which are mAb fused to prodrug cytokine masked by another protein, Reagent Requirements for all Domains, Considerations for Monitoring the Intact molecule
    Dr. Christine Grimaldi, Director, Regeneron Pharmaceuticals

  • Topic 7:

    LBA & hELISA for RNAi PK/PD Support - Advanced Bioanalytical approaches to advance the development of RNAi Therapeutics, Generate Reproducible Endogenous QC Samples for Robust Biomarker Assays, Development of NHP Biomarker Assays using Human Assay Reagents, hELISA assays of Comparable Sensitivity with qPCR
    Dr. Guodong Zhang, Director, Alnylam

Session 3: Novel Approaches for LBA BMV/Samples Analysis & Tissues Analysis

  • Topic 8:

    LBA Single Well-Analysis (Singlicate) for PK & ADA Assays: Recent applications for Method Validation and Sample Analysis for both PK and ADA Assays, Current Regulatory Requirements and Previous Recommendations, Clinical Data of the LBA Singlicate Approach with Tri-specific Antibody
    Ms. Susana Liu, Associate Director, Clinical Bioanalytics, Pfizer

  • Topic 9:

    Lessons Learned & Reflections on LBA Single Well Analysis (Singlicate) and Value of the NAb Assay data: Evaluation of ADA/NAb responses from Phase 1 to Phase 3, Reasoning behind Switching to Singlicate Analysis for Phase 3 Study, Ensuring Results Validity obtained by Statistical Analysis Performed with the Phase 1 Study Results
    Dr. Corinne Petit-frere, Director Clinical Pharmacology & Immunology, Fresenius Kabi SwissBioSim

  • Topic 10:

    Is Tissue LBA Bioanalysis feasible? Can LBA alone, rather than Hybrid and/or Mass Spec assays, succeed in overcoming Tissue Bioanalysis issues? Considerations for the use of LBAs for Tissue Analysis, Best Platform/Format and Novel Technologies, Sample Processing for Tissue Disruption/Homogenization
    Ms. Beth Leary, Principal Scientist, Pfizer

Session 4: Advanced Labeled Critical Reagents Strategies and Hybridoma Phage Display Approach

  • Topic 11:

    Generation of Labeled Critical Reagents for ADA assays for AAV-based Gene Therapies: Novel Approaches and Challenges in Development of Labeling Techniques that aid ADA Assay Creation, Obstacles during Biotin and Ruthenium labeling, Characterizing Labeled Molecule and Evaluating Conjugation Effectiveness
    Dr. Nisha Palackal, Director, Regeneron

  • Topic 12:

    Advanced Critical Reagent Strategies: Guidelines for Recertification, Expiry Extension and Hybridoma Phage Display Development, Comparison of Anti-id generation strategies Animal vs Non-animal platform, Precise Characterization and Better Consistency for Non-neutralizing anti-IDs to support total PK and Biomarker assay
    Dr. Yong Jiang, Associate Director, GSK

  • Topic 13:

    Application of Recombinant Calibrators for LBA: Issue with Lot-to-lot Differences with Protein Calibrators for Biomarker LBA and Impact on Assay Performance, Strategies for Measuring Epitope Specific Active Concentration Analysis, Importance to determine Active Concentration rather than Total Concentration for Biomarker LBA Calibrators
    Dr. Shannon Chilewski, Principal Scientist, BMS

Session 5: 2023 White Paper in Bioanalysis

  • 2023 White Paper on Ligand Binding Assays - Latest Developments, Challenges, and Solutions

    Consensus & Conclusions on Ligand Binding Assays - Latest Developments, Challenges, and Solutions for 2023 White Paper

Agenda at a Glance Agenda at a Glance