Main Workshop DAY 3 - Thursday April 4, 2019, 7am to 6:30pm
"LBA, Cell-based Assays/Flow Cytometry, & Emerging Technologies DAY"
Day 3 Session List
Day 3A: LBA, Cell-based Assays/Flow Cytometry, and Emerging Technologies
Novel Bioanalytical Developments in Cancer Immuno & Gene Therapy
Immunogenicity: What’s New in Drug Tolerance & Sensitivity, Positive Controls (PC) Appropriateness, Clinical Relevance, PK, PD, ADA Data Correlation
PK assays & Biomarkers assays: Soluble Target & ADA Impact in PK, Vaccine Clinical Assays, Exploratory Biomarkers – Who are they?, Accuracy in Biomarkers Assays?
Panel Discussion on LBA, Cell-based Assays/Flow Cytometry, and Emerging Technologies - Consensus for 2019 White Paper in Bioanalysis
Day 3B: ICH M10 BMV Draft Guideline - LBA
Harmonized Topics on LBA among US FDA, EU EMA, Health Canada, Japan MHLW regulations
Unresolved Issues and On-going Industry/Regulators’ Discussions on LBA
Panel Discussion on ICH M10 BMV Draft Guideline LBA - Provide official Recommendations to ICH