Cutting-edge knowledge in harmonization of ADA/NAb Testing, Reporting, clinical Prediction (with traditional tools & with AI/ML implementation) , Mitigation and Management for Biotherapeutics & Biosimilars; Regulatory Feedbacks on use of S/N and 1-Tier approaches in submissions; Special focus on immunogenicity strategies/risk impact for ADC & Peptides; Understanding the Emerging Approaches for the Immunogenicity Assessment of Next-Generation Biotherapeutics; Lesson Learned on Integrated Summary of Immunogenicity (ISI); Impact of Drug Tolerance, Soluble Target and Interferences on a meaningful Clinical ADA Assessment; Newest case studies in Immunogenicity Assessment, Risk-based Approaches, Pre-existing Antibodies Interpretation and Clinical Relevance; Traditional KOL Industry/Regulators focused and highly interactive panel discussions on Immunogenicity Reporting, Submissions Outcome and recent Controversial Issues.

Novel Translational Biomarkers Identification with cutting-edge Multi-Assay Strategy, LBA & Mass Spec and challenges in Data Integration; Application of Fit for Purpose Validation (BAV) and COU Limitations as Primary Driver of the Validation Design; Development IVD/CDx assays for AAV Gene Therapy Patient Selection/Stratification and Drug Response Monitoring; Issues with IVD pre-analytical phase and Off-shelf CAP/CLIA assay use; Current best practices in Translational Science from Discovery/Exploratory Biomarkers to Clinical/Confirmatory Biomarkers for novel therapies; Overcoming challenges with Assay Sensitivity/Linearity; Recent developments in Vaccine Biomarkers LBA and Exosomes/Extracellular Vesicles; Technical issues with EU IVDR applications, risk assessment, impact on Biomarkers Strategies for clinical development; Implementing Clinical Biomarkers as Primary Endpoints; Novel data on lesson learned from using Fully Automated Singlicate LBA in real-life situations; Current best practices on Complex/Tissue Biomarkers; Considerations on Next Generation Biomarkers to optimize dosing & predict safety; Traditional KOL Industry/Regulators focused and highly interactive panel discussions on Biomarker Assays, BAV, IVD, CDx, and recent Controversial Issues. 

Cutting-edge Mass Spec methodologies in drug discovery/development applied to Novel Modalities, Protein Drugs, Biomarkers and Transgene; Automation/Robotic in Mass Spec; Strategies & novel case studies for complex method development for next-generation of Small Molecules, Peptides, Oligonucleotides (mRNA, siRNA, LNP, nanoliposomes), Bispecific ADC, Dual Payload ADC; Lesson Learned from Mass Spec Innovative Approaches and Technology Advancements by using PNA and Locked Nucleic Acid (LNA) Probe Hybridization and Multiplexing Discovery Bioanalysis; Strategies for improving throughput, sensitivity, resolution and multiplexed capabilities for Liposomal & Covalent drugs, Prodrugs and Low-Abundance Peptides; Developments in HRMS MS/MS Activation & Spectral Annotation using the Latest Generation of QTOF/Orbitrap for DAR Shift and Glycoform Changes; Multiple Nanoflow innovative applications; Increasing bioanalytical selectivity & sensitivity in presence of Isobaric/ADA Interferences; Application of Discovery Bioanalysis solution to Regulated Bioanalysis; Traditional KOL Industry/Regulators focused and highly interactive panel discussions on Discovery/Regulated Mass Spectrometry applications and recent Controversial Issues.

Cutting-edge LBA methodologies in drug discovery/development applied to Novel Modalities & Complex Biologics; Advanced/Innovative applications of Automation/Robotic, novel AI/ML-Driven workflows and integration in LBA development; Strategies & novel case studies for complex method development for next-generation of Antibody-Based Therapeutics, Multispecifics/Complex Biotherapeutics, Drug Conjugates, Biomarkers; Development of PEG/Anti-PEG and ultrasensitive ADA/Nab Assays; Cutting-edge advancements in LBA Critical Reagents generation and performance evaluation for Biotherapeutics, and Biomarkers application; Latest advances in the Method Development/Validation for LBA and Long-Term Maintenance to support Complex Biotherapeutics; Innovative approaches Critical Reagents Stability ; Understanding the unique challenges for Emerging Technologies (NULISA & Olink); Application of Discovery Bioanalysis solution to Regulated Bioanalysis; Traditional KOL Industry/Regulators focused and highly interactive panel discussions on Discovery/Regulated Ligand-Binding & Enzymatic Assays applications and recent Controversial Issues.

Cutting-edge CBA methodologies in drug discovery/development in Cellular Immunogenicity (NAb Assays & Newer NAb assay Formats), Cell Therapy (Cellular Kinetics & CAR T), Biomarkers (Receptor Occupancy & Target Engagement) ; Further development and implementation of AI/ML for High Parameter Cytometry applications and Data management; Recent approaches ELISpot development/validation and technology advancements; Innovative approaches for overcoming the issue in Flow Cytometry Extended Sample Stability and the Isolation of Peripheral Blood Mononuclear Cells (PBMCs) and improving Unstable Flow Cytometry Assays; Advancements in Regulatory T-cell (Treg) Panel for disease monitoring; Newest innovations in Spectral Flow Cytometry, Mass Cytometry, and Imagine Cytometry; Current status of Single-Cell Level Assays for High Dimensional Cytometry in clinical trials; Traditional KOL Industry/Regulators focused and highly interactive panel discussions on Discovery/Regulated Cell-Based Assays (Cytometry, ELISpot, In-vitro) applications and recent Controversial Issues.

Current challenges in the application of BMV Guidelines to Rare Matrix, Radiopharmaceuticals/New Modalities for Regulatory Submissions; Recently disclosed US FDA Complete Response Letters (CRLs); Method Transfer best practice on assets sourced from China; Objective Statistical Criteria for Cross-validation, Regulatory Inspections, ICH M10 Cross Validation - was Industry/Regulators’ harmonization reached? Recent advances in Patient Centric Sampling for Clinical Drug Development and Microsampling for Preclinical Drug Development in Regulated Bioanalysis; Updates on the evolving recommendations on Clinical Sample Management; Enhancing Bioanalytical Performance by Capability-based Trending; Partial Validation Strategy Beyond ICH M10 Guidelines for Different Matrices and Different Routes of Administration; Traditional KOL Industry/Regulators focused and highly interactive panel discussions on Regulated Bioanalysis Sampling, Validating, Analyzing & Reporting and recent Controversial Issues.

IMMUNOGENICITY: Recent Advances in the Immunogenicity Assessment & Clinical Relevance for Gene, Cell, Vaccine Therapies based on lesson learned from Regulatory Submissions; Challenges in applying the Current Paradigm for Immunogenicity Testing for Gene & Cell Therapies; Current Challenges in Assessing Preexisting Antibodies for Novel Capsid and Route of Administration and Regulatory Feedbacks on TAb/NAb Assays; Advances in Monitoring RNA Therapies Immunogenicity; Latest Insights on Next-Generation Cell & Vaccine Therapies and progress in the development and characterization of Next Generation CAR-T; Comprehensive Cellular Kinetics Strategy; TECHNOLOGIES Novel case studies and challenges in the expanded application/validation of qPCR, dPCR and ddPCR assays for Genetic Multiplexing, Transgene and Target Gene Expression; Cutting-edge Next-Generation Sequencing (NGS), Whole Genome Sequencing and Nanostring applications in Bioanalysis and how the bioanalytical labs are handling the method development and validation for NGS and Nanostring; Current Challenges in the development of Multiplex qPCR & NanoString Assays; Traditional KOL Industry/Regulators focused and highly interactive panel discussions on Discovery/Regulated Gene, Cell, and Vaccine Therapies Immunogenicity & Technologies applications and recent Controversial Issues.