Agenda in Charts according to your Interest

Full Immersion Agenda Chart

Monday
Full-Day Specialized Workshop M1:
Biotherapeutics Immunogenicity Assessment & Clinical Relevance - Latest Advances, Challenges and Solutions
OR
Full-Day Specialized Workshop M2:
Biomarkers Discovery, Development, Validation & Regulatory Approval - Latest Advances, Challenges and Solutions
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 Immunogenicity/Technologies of Biotherapeutics, and Gene, Cell & Vaccine Therapies: Regulators' Inputs & ASK THE REGULATORS - Interactive Panel Discussion with Regulators
2B: Regulators' Advice on Bioanalytical Method Validation (BMV) and Biomarkers Assay Validation (BAV): Regulators' Inputs & ASK THE REGULATORS - Interactive Panel Discussion with Regulators
Thursday
Main Workshop Day 3:
Mass Spectrometry, Chromatography, and Sample Preparation:
  • Innovation and Novel Solutions for Chromatographic Assays
  • Novel Modalities Advanced Mass Spectrometry Applications
  • 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 - Latest Advances, Challenges and Solutions
OR
Full-Day Specialized Workshop F2:
Gene, Cell, and Vaccine Therapies Immunogenicity & Technologies - Latest Advances, Challenges and Solutions

Mass Spec Focus Agenda Chart

Monday
Full-Day Specialized Workshop M2:
Biomarkers Discovery, Development, Validation & Regulatory Approval - Latest Advances, Challenges and Solutions
Tuesday
Full-Day Specialized Workshop T1:
Mass Spectrometry Assays - Latest Advances, Challenges and Solutions
Wednesday
Main Workshop Day 2:
2A: Regulators' Advice on Immunogenicity/Technologies of Biotherapeutics, and Gene, Cell & Vaccine Therapies: Regulators' Inputs & ASK THE REGULATORS - Interactive Panel Discussion with Regulators
2B: Regulators' Advice on Bioanalytical Method Validation (BMV) and Biomarkers Assay Validation (BAV): Regulators' Inputs & ASK THE REGULATORS - Interactive Panel Discussion with Regulators
Thursday
Main Workshop Day 3:
Mass Spectrometry, Chromatography, and Sample Preparation:
  • Innovation and Novel Solutions for Chromatographic Assays
  • Novel Modalities Advanced Mass Spectrometry Applications
  • 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 - Latest Advances, Challenges and Solutions

Ligand-Binding Focus Agenda Chart

Monday
Full-Day Specialized Workshop M1:
Biotherapeutics Immunogenicity Assessment & Clinical Relevance - Latest Advances, Challenges and Solutions
OR
Full-Day Specialized Workshop M2:
Biomarkers Discovery, Development, Validation & Regulatory Approval - Latest Advances, Challenges and Solutions
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 Immunogenicity/Technologies of Biotherapeutics, and Gene, Cell & Vaccine Therapies: Regulators' Inputs & ASK THE REGULATORS - Interactive Panel Discussion with Regulators
2B: Regulators' Advice on Bioanalytical Method Validation (BMV) and Biomarkers Assay Validation (BAV): Regulators' Inputs & ASK THE REGULATORS - Interactive Panel Discussion with Regulators
Thursday
Full-Day Specialized Workshop Th1:
Ligand-Binding Assays - Latest Advances, Challenges and Solutions
Friday
Full-Day Specialized Workshop F1:
Regulated Bioanalysis Sampling, Validating, Analyzing & Reporting - Latest Advances, Challenges and Solutions
OR
Full-Day Specialized Workshop F2:
Gene, Cell, and Vaccine Therapies Immunogenicity & Technologies - Latest Advances, Challenges and Solutions

Cell-Based Focus Agenda Chart

Monday
Full-Day Specialized Workshop M1:
Biotherapeutics Immunogenicity Assessment & Clinical Relevance - Latest Advances, Challenges and Solutions
OR
Full-Day Specialized Workshop M2:
Biomarkers Discovery, Development, Validation & Regulatory Approval - Latest Advances, Challenges and Solutions
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 Immunogenicity/Technologies of Biotherapeutics, and Gene, Cell & Vaccine Therapies: Regulators' Inputs & ASK THE REGULATORS - Interactive Panel Discussion with Regulators
2B: Regulators' Advice on Bioanalytical Method Validation (BMV) and Biomarkers Assay Validation (BAV): Regulators' Inputs & ASK THE REGULATORS - Interactive Panel Discussion with Regulators
Thursday
Full-Day Specialized Workshop Th2:
Cell-Based Assays - Latest Advances, Challenges and Solutions
Friday
Full-Day Specialized Workshop F1:
Regulated Bioanalysis Sampling, Validating, Analyzing & Reporting - Latest Advances, Challenges and Solutions
OR
Full-Day Specialized Workshop F2:
Gene, Cell, and Vaccine Therapies Immunogenicity & Technologies - Latest Advances, Challenges and Solutions