Agenda of the Week

21st 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
Austria AGES
Belgium FAMHP
Italy AIFA

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

21st 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 Ligand-Binding, Cell-Based, and Molecular Assays (DAY 1 & DAY 2) or 2-DAY Mass Spec, Chromatography, and 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 12 (7am to 5:30pm)
Specialized Workshop M1: (Full-Day) Immunogenicity Assessment, Harmonization & Clinical Relevance ADA/NAb Testing & Reporting Stand-alone NAb assay New Approach Methodologies (NAM) In silico/in vitro vs AI/ML prediction Regulatory Feedback on S/N and 1-Tier Pre-existing Ab meaningful interpretation Immunogenicity for: Peptides, oligonucleotide, ADC, Bi/Multispecifics, TCE, Gene therapies, Next-generation biotherapeutics, Novel/complex modalities	Specialized Workshop M2: (Full-Day) Biomarkers Discovery, Development, Validation & Regulatory Approval LBA & Mass Spec (MSA) biomarker development Fit for Purpose Validation (BAV) Multiplex/OMICs/High-Plex Integrating AI/ML in biomarker strategy IVD/CDx assays development CAP/CLIA/ISO assays Strategies to meet EU IVDR Development/Validation of biomarkers for: Target Engagement (TE) PD, Vaccine LBA, Discovery/Exploratory, Clinical/Confirmatory
Continental Breakfast Morning Snacks and Beverages Hot Buffet Lunch Afternoon Snacks and Beverages
WRIB Welcome Reception 05:30pm-06:30pm at Ballroom Foyer

Tuesday April 13 (7am - 5:30pm)
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 Mass Spec Applications for Novel Modalities: AAV Gene Therapy, Bispecific T Cell Engager, Small Molecules Covalent Inhibitors, Low-abundance Peptides, Oligonucleotides, Antibody Oligonucleotide Conjugates, Targeted Protein Degraders, Dual-Payload ADCs, Liposomal & Covalent drugs, Encapsulated Nanoparticle Payloads Automation/Robotic in Mass Spec
Continental Breakfast Morning Snacks and Beverages Hot Buffet Lunch Afternoon Snacks and Beverages Networking Wine & Beer Reception

Wednesday April 14 (7am - 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 15 (7am - 5:30pm)
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 LBA applications for Novel Modalities: Antibody-Based Therapeutics, Multispecifics, Complex Biotherapeutics, Drug Conjugates AI/ML-driven workflows & DOE Optimization Critical Reagents/Positive Controls Drug Tolerance, Soluble Target and Interferences PK/PD/ADA Singlicate Evaluation of Emerging Technologies Assay format and PC selection for Oligos	Specialized Workshop Th2: (Full-Day) Cell-Based Assays Cellular Immunogenicity (NAb Assays) Cell Therapy (Immunogenicity/Cellular Kinetics) Vaccines (Cell-Mediated Immunity) Biomarkers (RO & TE) Biofunctional Assays (BFA) AI/ML for High Parameter Cytometry ELISpot/FluoroSpot development Biodistribution Isolation of PBMCs Liquid Biopsies Biomarkers Focus on Spectral Cytometry Mass & Imagine Cytometry
Continental Breakfast Morning Snacks and Beverages Hot Buffet Lunch Afternoon Snacks and Beverages Networking Wine & Beer Reception

Friday April 16 (7am to 5pm)
Specialized Workshop F1: (Full-Day) Regulated Bioanalysis Sampling, Validating, Analyzing & Reporting BMV Guidelines for New Modalities AI/ML in Regulated Bioanalysis AI/ML adoption and governance NAMs in Regulated Bioanalysis NAMs applications in Preclinical Harmonization of Cross-validation Patient Centric Sampling Microsampling Automated Clinical Sample Management BA/BE Data Integrity Beyond ICH M10 Emerging Technologies	Specialized Workshop F2: (Full-Day) Gene, Cell, Vaccine Therapies Discovery, Development & Regulatory Approval Methodologies for Peak Vector/Transgene Exposure Biodistribution studies/guidelines mRNA Vaccines/Cancer Vaccines Oncolytic Virus Multiplex PCR and Sequencing for characterizing AAV capsid Gene editing CRISPR-Cas9 techniques High-performance CAR-T cells characterization Quantitative bias in PCR-based methods NGS method development/validation Viral Shedding Assay
Continental Breakfast Morning Snacks and Beverages Hot Buffet Lunch Afternoon Snacks and Beverages

	Main Workshop DAYs
	Specialized Workshops

You can click on the picture to view enlarged version to see details