Full Immersion Agenda Chart
Monday
Full-Day Specialized Workshop
M1:
Biotherapeutics/Biosimilars Immunogenicity Assessment & Clinical Relevance -
OR
Full-Day Specialized Workshop
M2:
Biomarkers Discovery, Development, Validation & Regulatory Approval -
Tuesday
Main Workshop Day 1:
Ligand-Binding, Cell-Based, and Molecular Assays:
- Immunogenicity (ADA/NAb) Assays
- Biomarkers and IVD/CDx/LDT Assays
- Gene Therapy, Cell Therapy, and Vaccine Assays
- Pharmacokinetic (PK) & Biodistribution Assays
- Regulatory Challenges for Ligand-Binding, Cell-Based, and Molecular Assays
Wednesday
Main Workshop Day 2:
2A:
Regulators' Advice on Bioanalytical Method Validation (BMV) & Biomarkers Assay Validation (BAV):
Regulators' Inputs & ASK THE REGULATORS - Interactive Panel Discussion with Regulators
2B:
Regulators' Advice on Immunogenicity/Technologies of Biotherapeutic, & Gene, Cell & Vaccine Therapies:
Regulators' Inputs & ASK THE REGULATORS - Interactive Panel Discussion with Regulators
Thursday
Main Workshop Day 3:
Mass Spectrometry, Chromatography, and Sample Preparation:
- Innovation/Automation, Emerging Technologies and Novel Solutions
- Gene Therapy, Immunogenicity and Biomarkers by Mass Spectrometry
- Small Molecules, Peptides, Oligonucleotides, and Large Molecules
- Hybrid/Immunoaffinity Mass Spectrometry (IA-MS) Assays
- High Resolution Mass Spectrometry (HRMS) Assays
- Regulatory Challenges for Mass Spectrometry Assays
Friday
Full-Day Specialized Workshop
F1:
Regulated Bioanalysis Sampling, Validating, Analyzing & Reporting -
OR
Full-Day Specialized Workshop
F2:
Gene, Cell, and Vaccine Therapies Immunogenicity & Technologies -
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