19th 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 07 (7am to 5:30pm)
Specialized Workshop
M1:(Full-Day)
Biotherapeutics Biosimilars & Immunogenicity Assessment & Clinical Relevance

Immunogenicity Assessment of Next-Generation Biotherapeutics;
ADA Testing, Reporting, Prediction, Mitigation, and Management;
Labeling Guidance & ISI;
ADA-Domain Characterization of Complex Biotherapeutics;
Risk-based Approaches; Pre-existing Antibodies Interpretation and Clinical Relevance;
Impact of Drug, Soluble Target, and Interferences

Specialized Workshop
M2:(Full-Day)
Biomarkers Discovery, Development, Validation & Regulatory Approval

Translational Science from Discovery to Clinical;
Identification of Relevant Biomarkers by LBA & Mass Spec;
Assay Sensitivity and Emerging Platforms;
Vaccine Biomarkers;
US CLIA & LDT Rule and EU IVDR;
CDx Development for Gene Therapy;
High-Plex Technologies and Data Integration

Continental Breakfast
Morning Snacks and Beverages
Hot Buffet Lunch
Afternoon Snacks and Beverages
Welcome Reception
 
Tuesday April 08 (7am to 6pm)
Main Workshop
Day 1:
Ligand-Binding, Cell-Based & Molecular Assays

Immunogenicity (ADA/NAb) Assays;
Biomarker 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

Mass Spec Applications to Novel Modalities;
Next-Generation of Small Molecules, Peptides, Oligonucleotides, Protein Degraders;
Multiplexing Machine Learning in Discovery;
Sample Preparation Approaches in Tissues;
QTOF/Orbitrap Latest Generation;
Mass Spec of Protein Drugs, Biomarkers, and Transgene;
Overcoming Isobaric Interferences

Continental Breakfast
Morning Snacks and Beverages
Hot Buffet Lunch
Afternoon Snacks and Beverages
Networking Wine & Beer Reception
 
Wednesday April 09 (7am to 6pm)
Main Workshop
Day 2A:
Regulators’ Advice on Immunogenicity of Biotherapeutics, Gene Therapy, Cell Therapy, and Vaccine

Regulatory Inputs &
ASK THE REGULATORS - Panel Discussion
Main Workshop
Day 2B:
Regulators' Advice on Bioanalytical Method Validation (BMV) & Biomarkers Assay Validation (BAV)

Regulatory Inputs &
ASK THE REGULATORS - Panel Discussion
Continental Breakfast
Morning Snacks and Beverages
Hot Buffet Lunch
Afternoon Snacks and Beverages
Networking Wine & Beer Reception
 
Thursday April 10 (7am to 6pm)
Main Workshop
Day 3:
Mass Spectrometry, Chromatography, Sample Preparation

Innovation and Novel Solutions for Chromatographic Assays;
Small Molecules, Peptides, Oligonucleotides, and Large Molecules;
Hybrid/Immunoaffinity Mass Spectrometry (IA-MS) Assays;
High-Resolution Mass Spectrometry (HRMS) Assays;
Regulatory Challenges for Mass Spec Assays

Specialized Workshop
Th1:(Full-Day)
Ligand-Binding Assays

LBA Applications to Novel Modalities;
Automation/Robotic, ML, DOE in LBA;
Next-generation of Antibody-Based Therapeutics, Drug Conjugates, Biomarkers;
LBA Super Sensitive ADA/Nab;
Critical Reagents/Positive Controls for Novel Modalities and Emerging Technologies;
Enzymatic Assays to Support Gene Therapy

Specialized Workshop
Th2:(Full-Day)
Cell-Based Assays

Cellular Immunogenicity (NAb Assays);
Cell Therapy (Cellular Kinetics & PK for CAR-T);
Biomarkers (RO & TE);
Vaccines (CMI and Functional Assays);
ELISpot/FluoroSpot Development;
Isolation of PBMCs;
Liquid Biopsies ctDNA for Disease Monitoring;
Spectral, Mass, Imagine Cytometry;
AI/ML for High Parameter Cytometry

Continental Breakfast
Morning Snacks and Beverages
Hot Buffet Lunch
Afternoon Snacks and Beverages
Networking Wine & Beer Reception
 
Friday April 11 (7am to 5:30pm)
Specialized Workshop
F1:(Full-Day)
Regulated Bioanalysis Sampling, Validating, Analyzing & Reporting

BMV Guidelines for New Modalities;
AI/ML in Regulated Bioanalysis, SOP, Method Development;
Patient-Centric Sampling for Clinical Development;
Microsampling for Preclinical Development;
Clinical Sample Management;
BA/BE Testing Samples and Data Integrity Guidance;
Emerging Technology Validation;
Beyond ICH M10

Specialized Workshop
F2:(Full-Day)
Gene, Cell, and Vaccine Therapies Immunogenicity & Technologies

Immunogenicity of Gene/Cell/Vaccine Therapies based on Regulatory Submissions;
ISI and Current Immunogenicity Testing;
Clinical Relevance with focus on TAb/NAb Assays;
Next-Generation CAR-T;
Applications of NGS/Nanostring in Bioanalysis;
Novel Case Studies for qPCR and dPCR;
Understanding qPCR/ddPCR Data Comparability

Continental Breakfast
Morning Snacks and Beverages
Hot Buffet Lunch
Afternoon Snacks and Beverages
 
Main Workshop DAYs
Specialized Workshops
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