Training Session M1

Advanced Biomarkers Development & Troubleshooting by LBA & Flow Cytometry:
Challenges from Exploratory to Clinical/Confirmatory Biomarkers, Fit-for-Purpose, Context of Use and New Platforms

Specialized Session M2

BMV Guidance Day:
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

Training Session T1

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

Specialized Session T2

Innovation in Flow Cytometry, Mass Cytometry, and Imaging Cytometry to Solve Complex Method Development Issues in Drug Discovery/Development and Clinical Applications:
What's New for Bioanalytical Labs using Cytometry for Biomarkers, Immunogenicity, Cell Therapy and Cellular and Immuno-Oncology Assays?"

Training Session 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

Specialized Session F1

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

Specialized Session F2

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