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