In addition to the sequential 3-DAY Main Workshop program, 7 full-day Specialized Workshops will spread throughout the week to give you many choices to combine Main Workshop DAYs with these Specialized Workshops based on your specific track of interest and learning needs.
Most Recent Developments on Immunogenicity Regulations Harmonization, Testing & Reporting, Risk-Based Approaches, Prediction, Mitigation and Management; Updates on the US FDA Draft Immunogenicity Labeling Guidance; Immunogenicity of Complex/Novel Biotherapeutics and Biosimilars; Newest Case Studies in Immunogenicity Assessment, Pre-Existing Antibodies Interpretation and Clinical Relevance; Lesson Learned on Integrated Summary of Immunogenicity (ISI); Challenges Associated with Reporting NAb data; Latest Progress in Improving Cut Point, False Positivity Rate (FPR) and Drug/Target Tolerance/Interference; Industry/Regulators Focused and Interactive Discussions on Immunogenicity Reporting, Submissions Outcome and recent Controversial Issues
From Discovery/Exploratory Biomarkers to Clinical/Confirmatory Biomarkers Latest Progress in LBA & Mass Spec Development/BAV; Recent Issues in Development of CDx for Patient Selection/Stratification and Drug Response Monitoring; State-of-the-art Multiplex/OMICs Discovery Biomarkers Novel Platform; Current Challenges in Implementing Clinical Biomarkers as Primary Endpoints; Recent Development/Industry Practice in Vaccine Biomarkers LBA Development/Validation; Recent Progress in Fit-for-Purpose Biomarker Assay Validation (FFP BAV) Application and ISR/Parallelism; Novel Data on Lesson Learned from using New Platforms and Patient Centric/Micro Sampling in Real-Life Situations; Current Best Practices on Tissue Biomarkers; Industry/Regulators Focused and Interactive Discussions on BAV, IVD/CDx and Recent Controversial Issues
Mass Spec Applications of Novel Modalities/Protein Degraders; Solving New & Old Challenges with Mass Spec Innovative Approaches in Small Molecules, Peptides, Oligonucleotides and Large Molecules/ADC Method Development/Validation; Lesson Learned from Mass Spec Technology Advancements in Discovery Bioanalysis; Recent Developments in Tissues/Non-Liquid Matrices; Novel Advancements in Intact Protein Bioanalysis and Sample Preparation/Immunoaffinity (IA), QTOF/Orbitrap Bioanalysis; Data-Independent Acquisition Mass Spectrometry for Biomarker Discovery; Application of Discovery Bioanalysis Solution in Regulated Bioanalysis
LBA Applications in Novel Modalities; Solving New & Old Challenges with LBA Innovative Approaches in Complex Biotherapeutics, Biomarkers, ADA/NAb Method Development/Validation; Technology Advancements in Difficult LBA Development; Novel Applications of Artificial Intelligence (AI) for LBA; Latest Progress in Critical Reagents Generation/Performance; Noval Approaches for Bridging Highly Variable Critical Reagents Lots; Critical Reagent for New Modalities and New Assays Platforms; Application of Discovery Bioanalysis Solution in Regulated Bioanalysis
Cell-Based Assays Applications in Cellular Immunogenicity/NAb Assays, Cellular Kinetics for Cell Therapy/CAR-T Cells and Vaccine Functional Assays; Issues in Reporting NAb Data from Cell-Based Assays; Recent Approaches in ELISpot Development/Validation and Technology Advancements; Regulatory Expectation on ELISpot Assays for Submitted Studies; Newest Innovations in Spectral Cytometry, Mass Cytometry, and Imaging Cytometry; Novel Applications of Artificial Intelligence (AI) for Flow Cytometry; New Development in Flow Cytometry for Exploratory & Clinical Biomarkers/IVDs; Current Status of Single-Cell Assays for High Dimensional Cytometry in Clinical Trials
Understanding the Critical Importance of GCP & Clinical Sample Management/Reconciliation in Mass Spec & LBA Regulated Bioanalysis; Sample Collection/Integrity and Direct Impact of Discrepancies in Bioanalysis; Building/Developing Reliable Sample Management Internal Strategies/SOP Based on Previous WRIB Recommendations; Are ICH M10 Adoption and Transition being Successfully Completed or are there still Issues for Mass Spectrometry & Ligand Binding Assays? Ongoing Evolution in Microsampling, 3R and Patient Centric Sampling in Regulated Bioanalysis; Validation of Emerging Technologies in Regulated Bioanalysis; Industry/Regulators Focused and Interactive Discussions on Regulated Bioanalysis/BMV and Recent Controversial Issues
Latest Progress in qPCR, dPCR, and ddPCR Method Development and Validation for Genetic Multiplexing, Transgene and Target Gene Expression; Action Plan to address qPCR & ddPCR Cross-Validation/Discrepancies; Increasing Applications of NGS in Bioanalysis and Developing Next Level Recommendations; Novel Applications of nanoString in Gene Therapy; Latest Case Studies on Immunogenicity of Gene/Cell/Vaccine Therapies based on Lessons Learned from Regulatory Expectations Focusing on TAb vs.NAb Assays as a Companion Diagnostic (CDx); Progress in Development and Characterization of Next Generation CAR-T; Industry/Regulators Focused and Interactive Discussions on Molecular Assays and Immunogenicity of Gene Therapy, Cell Therapy, and Vaccine and Recent Controversial Issues
See Below Agenda at a Glance to find out how to combine these Full-Day Specialized Workshops with Main Workshop DAYs:
