Seven full-day Specialized Workshops Throughout the Week

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.

Monday Specialized Workshops - May 06, 2024: 7am to 5:30pm

  • Full-Day Specialized Workshop M1:
    Advanced Strategies for Immunogenicity of Biotherapeutics - :

    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)

  • Full-Day Specialized Workshop M2:
    Advanced Strategies for Biomarkers and IVD/CDx Assays - :

    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

Tuesday Specialized Workshop - May 07, 2024: 7am to 5:50pm

Thursday Specialized Workshops - May 09, 2024: 7am to 6pm

Friday Specialized Workshops - May 10, 2024: 7am to 5:30pm

  • Full-Day Specialized Workshop F1:
    Advanced Strategies for Regulated Bioanalysis & BMV - :

    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

  • Full-Day Specialized Workshop F2:
    Advanced Strategies for Molecular Assays and Immunogenicity of Gene Therapy, Cell Therapy and Vaccine - :

    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

See Below Agenda at a Glance to find out how to combine these Full-Day Specialized Workshops with Main Workshop DAYs:

Click to Enlarge to See Detailed Programs of Each Main Workshop DAY or Each Specialized Workshop

Agenda at a Glance Agenda at a Glance