Most Recent Developments on Immunogenicity Regulations Harmonization, Testing & Reporting, Risk-Based Approaches, MAPPs Prediction, Mitigation and Management; Immunogenicity of Complex/Novel Biotherapeutics and Biosimilars; Newest Case Studies in Immunogenicity Assessment, Pre-Existing Antibodies Interpretation and Clinical Relevance; Challenges Associated with Reporting NAb data; Latest Progress in Improving Cut Point, False Positivity Rate (FPR) and Drug/Target Tolerance/Interference; Final Proposal for Cross-Validation; Industry/Regulators Focused and Interactive Discussions on Immunogenicity Reporting, Submissions Outcome and recent Controversial Issues; Interactive Regulatory Updates on the US FDA Draft Immunogenicity Labeling Guidance & Lesson Learned on Integrated Summary of Immunogenicity (ISI)

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 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; 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; Mass Spectrometry for Biomarker Discovery; Application of Discovery Bioanalysis Solution in Regulated Bioanalysis

LBA Applications in Novel Modalities; Leveraging Multiple Platforms in Integrative Bioanalysis; Solving New & Old Challenges with LBA Innovative Approaches in Complex Biotherapeutics, PK/Biomarkers/ADA LBA; TAb/NAb for Gene Therapy Method Development/Validation; Super Sensitive Technology Advancements in ADA LBA Development; Latest Progress in Critical Reagents & Positive Controls Generation/Performance; Novel 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 CBA Development/Validation and Technology Advancements; Regulatory Expectation on CBA for Submitted Studies; Newest Innovations in High Dimensional Flow Cytometry/Mass Cytometry; Novel Applications of Artificial Intelligence (AI) & Machine Learning (ML) for Flow Cytometry; New Development in Flow Cytometry for Exploratory & Clinical Biomarkers/RO/TE; 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; Fit for Purpose (FFP) vs Full Validation for Automated Methods, Cross-Validation, Protein Binding and Urine Analysis; Are ICH M10 Implementation being Successfully Completed or are there still Issues for Mass Spectrometry & Ligand Binding Assays? Ongoing Evolution in Microsampling Preclinical 3R and Patient Centric Sampling in Regulated Bioanalysis; Validation of Emerging Technologies and ELN in Regulated Bioanalysis; Industry/Regulators Focused and Interactive Discussions on Regulated Bioanalysis/BMV and Recent Controversial Issues

IMMUNOGENICITY: Latest Case Studies on Immunogenicity Risk Assessment & Mitigation for Gene/Cell/Vaccine Therapies based on Lessons Learned from Regulatory Expectations; Progress in Development of Allogenic Cell Therapy Immunogenicity Assays and Characterization of Next Generation CAR-T; Recent Regulatory Guidelines for Vaccines and impact on Bioanalysis. TECHNOLOGIES: Latest Progress in PCR-based Assays, Method Development and Validation for Genetic Multiplexing, Transgene and Target Gene Expression; Action Plan to address qPCR/bDNA Cross-Validation/Discrepancies; Increasing Applications of NGS/Genomic Assays in Bioanalysis and Developing Next Level Recommendations; Novel Applications of NGS/Genomic Assays in CRISPR Gene Editing and FFPE Sample Analysis; Industry/Regulators Focused and Interactive Discussions on Molecular Assays and Immunogenicity of Gene Therapy, Cell Therapy, and Vaccine and Recent Controversial Issues