20th WRIB Highlights

Full Immersion in Bioanalysis
  • Small & Large Molecules
  • Biomarkers
  • Immunogenicity
  • Gene/Cell Therapy
  • Vaccine Assays
  • Critical Reagents
  • Peptide & Oligos
  • New Modalities
  • LBA, Flow Cytometry
  • PCR, ELISpot, NGS
  • LC-MS/MS & HRMS
  • Hybrid LBA/LCMS
  • Emerging Technologies
Hear from Regulators...
  • US FDA
  • EU EMA
  • UK MHRA
  • Health Canada
  • Brazil ANVISA
  • Japan MHLW
  • Austria AGES
  • Norway NoMA
  • WHO
Learn What's New...
  • Method Dev. Challenges
  • Novel Case Studies
  • Emerging Approaches
  • Regulatory Standards
3-DAY Main Workshop
  • No Overlap Parallel Sessions
  • Flexibility to Choose Main Workshop DAYs
7 full-day Specialized Workshops
  • Spread throughout the week
  • Each with an in-depth Focus to maximize your learning process
Personalized Agenda
  • Choose your Main Workshop DAYs
  • Then Combine with Specialized Workshops of your interest
Questions to Regulators
  • Ask them directly to regulators at WRIB
  • Or Submit yours questions before WRIB if you want to be anonymous
Complete Speakers Slides
  • Distributed BEFORE meeting
Poster Awards
  • Free Registration for Next WRIB
  • Interviewed by Bioanalysis Journal
  • Appear in a speical feature report in the Bioanalysis Journal and on Bioanalysis Zone

Agenda in Charts according to your Interest

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 -
You can click on the chart to view enlarged version in a new browser page

Mass Spec Focus Agenda Chart

Monday
Full-Day Specialized Workshop M2:
Biomarkers Discovery, Development, Validation & Regulatory Approval -
Tuesday
Full-Day Specialized Workshop T1:
Mass Spectrometry 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 -
You can click on the chart to view enlarged version in a new browser page

Ligand-Binding Focus 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
Full-Day Specialized Workshop Th1:
Ligand-Binding 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 -
You can click on the chart to view enlarged version in a new browser page

Cell-Based Focus 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
Full-Day Specialized Workshop Th2:
Cell-Based 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 -
You can click on the chart to view enlarged version in a new browser page