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.
NEW Case Studies and Lesson Learned on Immunogenicity Assessment, Interpretation and Clinical Relevance; Advancements on Harmonization of Immunogenicity Regulations, Risk-Based Approaches, Prediction, Mitigation and Management; Issues in ADA Validation Harmonization & ADA Assays Comparability; Improving Cut Point and FPR Calculation; Complex Biotherapeutics, Bispecific Antibody and Biosimilars S/N Immunogenicity Progresses; Industry/Regulators Interactive Discussions on Immunogenicity Reporting, Submissions Outcome and Recent Controversial Issues
NEW Case Studies on Biomarker Strategies for LBA & Mass Spec Method Development; Low Abundant Proteins/Exosomes Discovery Biomarkers; Implementing Clinical Biomarkers as Primary Endpoints (CLIA vs GCLP); Challenges with Regulatory BAV Guidance; Biomarker Validation as CDx and CLIA Approved Assays; Development in Vaccine Biomarkers Immunoassay, Interferences, Dilutional Linearity, RSM; Industry/Regulators Interactive Discussions on BAV, IVDR and CDx and Recent Controversial Issues
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
NEW Case Studies on Cell-Based & Flow Cytometry Innovative Approaches and Technology Advancements for Exploratory/Clinical Cellular Biomarkers, Cellular Immunogenicity, Cellular Kinetics for CAR-T/Cell Therapy, and Vaccine Functional Assays/CMI/ICS; Novel Techniques to Extend Flow Cytometry Capabilities for Quality Data Generation; Auto-Gating, Modular Approach Developments; High Dimensional Cytometry; Overcoming Sample Stability Limitations; Newest Innovations in Spectral Cytometry, Mass Cytometry, and Imagine Cytometry
NEW Case Studies on ICH M10 Adoption & Transition One Year after its Implementation; Special Session on US FDA Remote Regulatory Assessments (RRAs) direct experience from Pharma/CRO; Controversial Issues for Mass Spec & LBA on Stability, Dilution QC, Cross Validation, Hybrid Assays; Ongoing Evolution in Patient Centric Sampling & Sample Collection; Harmonization on GCP & Clinical Sample Management; Alternatives to Conventional QC-Based Bioanalysis; Industry/Regulators Interactive Discussions on Audits/Inspections/Submissions Outcomes
NEW Case Studies on Immunogenicity of Gene/Cell/Vaccine Therapies; Regulatory Expectations on Whats Really Needed for Immunogenicity Assessment; TAb or NAb and when Companion Diagnostic (CDX) is needed; Continuing the Industry/Regulators Discussion on LNP & Viral Vectors Immunogenicity; Progress in Tracking CAR-T Cells; Biodistribution of Replication Competent Viral Vectors and Vaccines; Method Development & Validation Strategies for ELISpot; Novel Applications of Next Generation Sequencing (NGS) & NanoString in Gene Therapy; State-of-the-art Recommendations for qPCR & ddPCR Validation; Latest Progress in High-Performance ddPCR for Genetic Assays
See Below Agenda at a Glance to find out how to combine these Full-Day Specialized Workshops with Main Workshop DAYs:
