In addition to the sequential 3-DAY Main Workshop program, 7 full-day Specialized Workshops spreads 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.
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; 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 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 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) in Bioanalysis and How Bioanalytical Labs are Handling the Method Development and Validation for NGS; 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 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
See Below Agenda at a Glance to find out how to combine these Full-Day Specialized Workshops with Main Workshop DAYs:
