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 of the Week

19th WRIB continues to feature the unique 3-DAY Main Workshop sequential program (DAY 1, DAY 2 and DAY 3). However you have the flexibility to select 2-DAY Main Workshop - either 2-DAY LBA, Flow Cytometry, PCR & ELISpot (DAY 1 & DAY 2) or 2-DAY Mass Spec, Chromatography & Sample Prep (DAY 2 & DAY 3).

In addition to the Main Workshop DAYs, 7 full-day Specialized Workshops spreads throughout the week to give you many choices to combine Main Workshop DAYs with these Specialized Workshops to maximize your learning needs.

And more importantly, EACH workshop (main or specialized) will be addressing the Latest Advances, Challenges and Solutions from Internationally Recognized Key Opinion Leaders and Regulators.

Monday April 13 (7am to 5:45pm)
Specialized Workshop
M1: (Full-Day)
Biotherapeutics & Biosimilars Immunogenicity Assessment & Clinical Relevance

Harmonization of ADA/NAb Testing, Reporting, Mitigation and Management;

AI/ML Prediction;

Regulatory Feedback on S/N and 1-Tier;

Strategies for Oligonucleotide & Peptides;

Next-Generation Biotherapeutics;

Lesson Learned on ISI and Clinical Relevance;

ADA-Domain-Characterization of Complex Biotherapeutics;

Drug Tolerance, Soluble Target and Interferences;
Specialized Workshop
M2: (Full-Day)
Biomarkers Discovery, Development, Validation & Regulatory Approval

Novel Translational Biomarkers by Multiplex/HighPlex OMICs;

Application of 2025 FDA Guidance BMV for Biomarkers;

CDx for Gene Therapy Patient Selection / Stratification;

Challenges with IVD pre-analytical phase;

Developments in Vaccine Biomarkers & Exosomes;

IVDR applications & Biomarkers Strategies;

Clinical Biomarkers as Primary Endpoints;
Continental Breakfast
Morning Snacks and Beverages
Hot Buffet Lunch
Afternoon Snacks and Beverages
Welcome Reception
 
Tuesday April 14 (7am - 5:45pm)
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;
Specialized Workshop
T1: (Full-Day)
Mass Spectrometry Assays

Cutting-edge MS methodologies for Novel Modalities, Protein Drugs, Biomarkers, Transgene, Small Molecules, Peptides, Oligonucleotides, Protein Degraders, Liposomal & Covalent drugs, Prodrugs and Low-abundance Peptides;

Technology Advancements in LNA Probe Hybridization and MS Multiplexing;

HRMS latest generation;

Multiple nanoflow & IMS;
Continental Breakfast
Morning Snacks and Beverages
Hot Buffet Lunch
Afternoon Snacks and Beverages
Networking Wine & Beer Reception
 
Wednesday April 15 (7am to 5:45pm)
Main Workshop
Day 2A:
Regulators' Advice on Bioanalytical Method Validation (BMV) & Biomarkers Assay Validation (BAV)

Latest Regulatory Inputs from Major/Influential Regulatory Agencies;

ASK THE REGULATORS! - WRIB Traditional Interactive Panel Discussion with Regulators;
Main Workshop
Day 2B:
Regulators' Advice on Immunogenicity/Technologies of Biotherapeutic, & Gene, Cell & Vaccine Therapies

Latest Regulatory Inputs from Major/Influential Regulatory Agencies;

ASK THE REGULATORS! - WRIB Traditional Interactive Panel Discussion with Regulators;
Continental Breakfast
Morning Snacks and Beverages
Hot Buffet Lunch
Afternoon Snacks and Beverages
Networking Wine & Beer Reception
 
Thursday April 16 (7am - 5:45pm)
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;
Specialized Workshop
Th1: (Full-Day)
Ligand-Binding Assays

Cutting-edge LBA methodologies for Novel Modalities & Complex Biologics;

Next-generation of Antibody-Based Therapeutics & Drug Conjugates;

Low-abundance Biomarkers & supporting Gene Therapy;

Automation/Robotic & AI/ML-driven workflows in LBA;

Critical Reagents / Positive Controls for Novel Modalities & Emerging Technologies in LBA;
Specialized Workshop
Th2: (Full-Day)
Cell-Based Assays

Cell Therapy (Cellular Kinetics), Cellular Immunogenicity (NAb Assays);

RNA Therapies (Transgene RNA/Protein by PrimeFlow);

Biomarkers (RO & TE), Vaccines (CMI /Functional Assays);

AI/ML for High Parameter Cytometry;

ELISpot/FluoroSpot development;

Isolation of PBMCs & Liquid Biopsies Biomarkers;

Spectral, Mass, Imagine Cytometry;
Continental Breakfast
Morning Snacks and Beverages
Hot Buffet Lunch
Afternoon Snacks and Beverages
Networking Wine & Beer Reception
 
Friday April 17 (7am to 5pm)
Specialized Workshop
F1: (Full-Day)
Regulated Bioanalysis Sampling, Validating, Analyzing & Reporting

BMV Guidelines for New Modalities for Regulatory Submissions;

AI/ML in Regulated Bioanalysis & AI Reporting;

Regulatory Inspections based on 2025 FDA BMV for Biomarkers;

PCS/ Microsampling Development;

Automated Clinical Sample Management;

BA/BE Data Integrity;

Beyond ICH M10 & Emerging Technologies;
Specialized Workshop
F2: (Full-Day)
Gene, Cell, and Vaccine Therapies Immunogenicity & Technologies

Immunogenicity Assessment & Clinical Relevance for Gene, Cell, Vaccine Therapies;

Validation for Immunogenicity T Cell Assay for Next-generation CAR-T;

Novel Vectors and TAb/NAb Assays;

Integrated Summary of Immunogenicity;

Current Validation Requirements for qPCR/ddPCR;

Cutting-edge applications of NGS/Nanostring in Bioanalysis;

qPCR/ddPCR data comparability / discrepancies;
Continental Breakfast
Morning Snacks and Beverages
Hot Buffet Lunch
Afternoon Snacks and Beverages
Main Workshop DAYs
Specialized Workshops
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