Understanding the Emerging Approaches for the Immunogenicity Assessment of Next-Generation Biotherapeutics; Advances/Challenges in Current ADA Testing, Reporting, Prediction, Mitigation and Management for Biotherapeutics & Biosimilars; Input from US FDA on Labeling Guidance and Integrated Summary of Immunogenicity (ISI); Advanced ADA-Domain-Characterization of Complex/Novel Biotherapeutics; Newest Case Studies in Immunogenicity Assessment, Risk-Based Approaches, Pre-Existing Antibodies Interpretation and Clinical Relevance; Impact of Drug, Soluble Target and Interferences on Clinical ADA Assessment; AND LASTLY WRIB Traditional KOL Industry/Regulators Focused and Highly Interactive Panel Discussions on Immunogenicity Reporting, Submissions Outcome and Recent Controversial Issues

Advances in Translational Science from Discovery/Exploratory Biomarkers to Clinical/Confirmatory Biomarkers; Latest Case Studies to Identify & Validate Relevant Biomarkers by LBA & Mass Spec and Challenge with Assay Sensitivity; Recent Developments in Vaccine Biomarkers LBA Validation; Impact of New Regulations for Biomarker Testing: US CLIA, US LDT Proposed Rule and EU IVDR; CDx Assay Development for Gene Therapy Patient Selection/Stratification and Drug Response Monitoring; Cutting-Edge Multiplex/OMICs/High-Plex Technologies in Discovery Biomarkers and Challenges in Data Integration; Implementing Clinical Biomarkers as Primary Endpoints; Novel Data on Lesson Learned from Using New Platforms and Patient Centric/Micro Sampling in Real-Life Situations; Current Best Practices on Complex/Tissue Biomarkers; And LASTLY, WRIB Traditional KOL Industry/Regulators Focused and Highly Interactive Panel Discussions on Biomarker Assays, BAV, IVD, CDx, LDT and Recent Controversial Issues

Understanding the Challenges of Mass Spec Applications to Novel Modalities; Advanced/Innovative Applications of Automation/Robotic, Machine Learning in Mass Spec; Strategies & Novel Case Studies for Complex Method Development for Next-Generation of Small Molecules, Peptides, Oligonucleotides (mRNA, siRNA, LNP, Nanoliposomes), Protein Degraders and Macrocylic/Large Molecules/ADC; Lesson Learned from Mass Spec Innovative Approaches and Technology Advancements in Multiplexing Discovery Bioanalysis; Influence of Different Sample Preparation Approaches in Tissues; Bioanalysis by MS/MS Activation, and Spectral Annotation in HRMS using the Latest Generation of QTOF/Orbitrap; Mass Spec of Protein Drugs, Biomarkers and Transgene; Increasing Bioanalytical Selectivity & Sensitivity in Presence of Isobaric Interferences; Application of Discovery Bioanalysis Solution to Regulated Bioanalysis; AND LASTLY, WRIB Traditional KOL Industry Focused and Highly Interactive Panel Discussions on Discovery/Regulated Mass Spectrometry Applications and Recent Controversial Issues

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

Understanding the Challenges of Cell-Based Assays Applications in Cellular Immunogenicity (NAb Assays), Cell Therapy (Cellular Kinetics & PK CAR T Cell Clinical Trials), Biomarkers (Receptor Occupancy & Target Engagement) and Vaccines (Cell-Mediated Immunity/Functional Assays); Recent Approaches ELISpot & FluoroSpot Development/Validation and Technology Advancements; Innovative Approaches for Overcoming the Issue in Isolation of Peripheral Blood Mononuclear Cells (PBMCs); Advancements in Liquid Biopsies ctDNA Biomarkers for Disease Monitoring; Regulatory Expectation on ELISpot Assays for Submitted Studies; Newest Innovations in Spectral Cytometry, Mass Cytometry, and Imagine Cytometry; Novel Applications of Artificial Intelligence (AI)/Machine Learning (ML) for High Parameter Cytometry Applications and Data management; Current Status of Single-Cell Assays for High Dimensional Cytometry in Clinical Trials; AND LASTLY WRIB Traditional KOL Industry/Regulators Focused and Highly Interactive Panel Discussions on Discovery/Regulated Cell-Based Assays (Cytometry, ELISpot, In-vitro) Applications and Recent Controversial Issues

Understanding How Current BMV Guidelines can be Applied to New Modalities for Regulatory Submissions; Leveraging/Applying Artificial Intelligence & Machine Learning Methodologies within Regulated Bioanalysis beyond Automation/Robotics; Can SOP being Written using AI/ML? Can AI/ML Help Develop Better and Faster Bioanalytical Method? Case Studies and Current Applications/Considerations; Recent Advances in Patient Centric Sampling for Clinical Drug Development and Microsampling for Preclinical Drug Development; Updates on the Evolving Recommendations on Clinical Sample Management; Applications of New Guidelines Related to Regulated Bioanalysis: BA/BE Testing Samples and Data Integrity Guidance; Validation of Emerging Technologies/Method in Regulated Bioanalysis: Beyond ICH M10; AND LASTLY, WRIB Traditional KOL Industry/Regulators Focused and Highly Interactive Panel Discussions on Regulated Bioanalysis Sampling, Validating, Analyzing & Reporting and Recent Controversial Issues

Recent Advances in the Immunogenicity of Gene/Cell/Vaccine Therapies Based on Lesson Learned from Regulatory Submissions; Advice on Putting Together the Integrated Summary of Immunogenicity (ISI) and Challenges in Applying the Current Paradigm for Immunogenicity Testing for Gene & Cell Therapies; Immunogenicity Assessment & Clinical Relevance with Focus on Regulatory Feedback on TAb/NAb Assays; Progress in the Development and Characterization of Next Generation CAR-T; Latest Updates on the Wide Applications of Next-Generation Sequencing (NGS) and Nanostring in Bioanalysis and How Bioanalytical Labs are Handling the Method Development and Validation for NGS and Nanostring; Novel Case Studies and Challenges in the Expanded Application of qPCR, dPCR and ddPCR Assays for Genetic Multiplexing, Transgene and Target Gene Expression; Understanding & Misunderstanding in qPCR/ddPCR Cross-Validation & Data Comparability; AND LASTLY, WRIB Traditional KOL Industry/Regulators Focused and Highly Interactive Panel Discussions on Discovery/Regulated Gene, Cell, and Vaccine Therapies Immunogenicity & Technologies Applications and Recent Controversial Issues