Specialized Workshop F1

Advanced Immunogenicity:
Implementation of 2019 FDA Immunogenicity Guidance, Nab Assays Harmonization, ADA Validation Reporting, Immunogenicity Risk Assessment, Regulatory Feedbacks & Controversial Issues

Specialized Workshop F2

Advanced Cell & Gene Therapy Bioanalysis:
Recent Advancements and New Frontiers for Bioanalytical Labs on Flow Cytometry, qPCR, ELISPOT, Regulatory Requirements, CAR-T and CRISPR Assays Case Studies

Specialized Workshop M1

Advanced Biomarkers Context of Use (CoU) Development & Troubleshooting:
Challenges from Exploratory to Clinical/Confirmatory Biomarkers, Fit-for-Purpose, Context of Use (COU) and New Platforms

Specialized Workshop M2

BMV Guidances:
Interpretations & Training on ICH M10 before its Adoption; Audits Outcome using 2018 FDA; Transition from Local Guidelines to ICH M10 with Gap Analysis on Controversial Issues

Specialized Workshop T1

LBA Advanced Method Development:
Solving Challenges with Innovative Approaches on Critical Reagents, Learning from Vaccine Assays, Multi-Domain Biotherapeutics, Emerging Technologies"

Specialized Workshop T2

Innovation in High Dimensional Flow Cytometry, Mass Cytometry, and Imaging Cytometry:
Solving Complex Method Development Issues in Bioanalytical Labs using Cytometry for Biomarkers, Immunogenicity, Cell Therapy and Cellular and Immuno-Oncology Assays?"

Specialized Workshop Th1

Mass Spec Advanced Method Development - Peptides, Oligos, SM and Biomarkers:
Solving Complex Challenges with Innovative Approaches on Sensitivity & Selectivity, Unstable/Sticky Compounds; Column Chemistry, Orthogonal Separations, Tissue Bioanalysis