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

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

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

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

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

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

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