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.
Full-Day Specialized Workshop M1:
Immunogenicity of Biotherapeutics - Latest Developments, Challenges, and Solutions:
NEW Case Studies on Immunogenicity Assessment, Pre-existing Antibodies Interpretation and Clinical Relevance; Most Recent Advancements on Harmonization of Immunogenicity Regulations, Risk-Based Approaches, Prediction, Mitigation and Management; Recent Issues in ADA/NAb Validation & Comparability; Latest Progress for Improving Cut Point and Drug/Target Tolerance/Interference; BsmAb/MDBs and Biosimilars Immunogenicity Progresses; Industry/Regulators Focused and Interactive Discussions on Immunogenicity Reporting, Submissions Outcome and Recent Controversial Issues
Full-Day Specialized Workshop M2:
Biomarkers & Companion Diagnostics - Latest Developments, Challenges, and Solutions:
NEW Case Studies on Biomarker Common Strategies for LBA, Flow Cytometry & Mass Spec Method Development; Multiplex/OMICs, Exosomes/Liquid Biopsy-Based Discovery Biomarkers; Implementing Clinical Biomarkers as Primary Endpoints; Challenges with Regulatory BAV Guidance and Complex Biomarkers/CDx Validation; Recent Development in Vaccine Biomarkers Immunoassay; Current Best Practices on Tissue Biomarkers; Industry/Regulators Focused and Interactive Discussions on BAV, IVDR and CDx and Recent Controversial Issues
Full-Day Specialized Workshop T1 for Mass Spectrometry Scientists:
Mass Spectrometry Assays - Latest Developments, Challenges, and Solutions:
NEW Case Studies on Mass Spec Innovative Approaches and Technology Advancements in Discovery Bioanalysis; Overcoming Challenges with Tissues Biopsies/Non-Liquid Matrices; Recent Method Development Strategies for Novel Modalities, Oligonucleotides, ADC Therapeutics, and Complex Biotherapeutics; Current Industry Experience in Column Chemistry, Narrow-Bore, Wide Pore Monolithic and Superficially Porous Stationary Phases; Ultra-Sensitive Methods by Nano/Micro LC; Overcoming Ongoing Challenge in Intact Protein Bioanalysis; Recent Discovery Solution Advancements and How to Transfer them to Regulated Bioanalysis
Full-Day Specialized Workshop Th1 for LBA Scientists:
Ligand Binding Assays - Latest Developments, Challenges, and Solutions:
NEW Case Studies on LBA Innovative Approaches and Technology Advancements for Complex Method Development; New Tools to Support Robust Immunoassays; Recent LBA Applications and Critical Reagents Development for New Modalities and BsmAb/MDBs; Current Status of Non-Animal-Based Critical Reagents Usage and Implementation; Novel Ultra-Sensitive LBA; Ongoing Efforts to Develop Clinically Relevant Positive Control for ADA LBA; Recent Discovery Solution Advancements and How to Transfer them to Regulated Bioanalysis
Full-Day Specialized Workshop Th2 for Cytometry scientists:
Flow Cytometry Assays - Latest Developments, Challenges, and Solutions:
NEW Case Studies on Flow Cytometry Innovative Approaches and Technology Advancements for Exploratory & Clinical Biomarkers, Biotherapeutics Cellular Immunogenicity, Cellular Kinetics for Cell Therapy, and Vaccine Functional Assays; Novel Techniques to Extend Flow Cytometry Capabilities to High-Throughput / High-Content and Single-Cell assays; Recent Auto-Gating Developments for High Dimensional Cytometry; Current Flow Cytometry IVD Applications for CDx; Importance of Using High-Quality PBMCs in Global Clinical Trials; Newest Innovations in Spectral Cytometry, Mass Cytometry, and Imagine Cytometry
Full-Day Specialized Workshop F1:
BMV and Regulated Bioanalysis - Latest Developments, Challenges, and Solutions:
NEW Case Studies on ICH M10 Adoption & Transition One Year after its Implementation; Industry/Regulators Focused and Interactive Discussions on Audits/Inspections/Submissions Outcome Based on Recent Guidelines in Bioanalysis; Computer System Validation (CSV); Data Integrity; Current Controversial Issues for Mass Spectrometry & Ligand Binding Assays in Regulated Bioanalysis; Ongoing Evolution in Microsampling, 3R and Patient Centric Sampling in Regulated Bioanalysis; Harmonization on GCP & Clinical Sample Management; Recent Issues in Integration of High Throughput Automation in Regulated Bioanalysis
Full-Day Specialized Workshop F2:
Gene Therapy, Cell Therapy and Vaccine - Latest Developments, Challenges, and Solutions:
NEW Case Studies on Immunogenicity of Gene/Cell/Vaccine Therapies; Recent Recommendations and Regulatory Expectations on What's Really Needed for Assessment of Immunogenicity; Integrated Summary of Immunogenicity (ISI) for Gene Therapy; Continuing the Industry/Regulators Discussion on LNP & Viral Vectors Immunogenicity; Progress in the Next Generation CAR-T; Updated 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 and Cross-validation; Latest Progress in High-Performance ddPCR for Genetic Multiplexing, Transgene and Target Gene Expression
See Below Agenda at a Glance to find out how to combine these Full-Day Specialized Workshops with Main Workshop DAYs:
