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 Replicating 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