Current status of ADA/NAb Testing, Reporting Harmonization and programs requiring stand-alone NAb assay; Recent developments of New Approach Methodologies (NAM) for immunogenicity risk assessment and regulatory expectations; Clinical Prediction with traditional integrated in silico and in vitro assessments vs AI/ML for tailored bioanalytical strategies and better understanding of B cell, T cell, innate immune activation; Emerging Approaches, newest data and Regulatory Feedback on S/N and 1-Tier approaches on clinical relevant ADA; Immunogenicity effect on safety, efficacy, and clinical data; Pre-existing Ab interpretation to generate clinically meaningful ADA data of complex modalities and anti-adeno-associated virus capsid antibodies; Newest case studies in immunogenicity assessment, strategies, clinical relevance for peptides, oligonucleotide, ADC, Bi/Multispecifics, TCE, cell/gene therapies, next-generation biotherapeutics, novel/complex modalities; Traditional KOL Industry/Regulators focused and highly interactive panel discussions on Immunogenicity Assessment, Harmonization & Clinical Relevance and recent Controversial Issues.

LBA & Mass Spec (MSA) challenges in complex biomarker development; Latest applications of Fit-for-Purpose Validation (BAV) in support of the 2026 US FDA Guidance BMV for Biomarkers; Identification/quantification of Novel Translational Biomarkers with Multiplex/OMICs/High-Plex by Emerging Technologies and Integrating AI/ML; Strategies in the Development/Validation of IVD/CDx Assays for Patient Selection/Stratification and Drug Response Monitoring; Updated Biomarkers Development Strategies to meet EU IVDR; Updated strategies for Biomarker assays in CAP/CLIA/ISO labs used in drug development; Strategies for development of Target Engagement (TE) PD biomarkers; Current best practices in Translational Science from Discovery/Exploratory Biomarkers to Clinical/Confirmatory Biomarkers for novel therapies; Overcoming challenges with Assay Sensitivity; Recent developments in Vaccine Biomarkers LBA; Implementing Clinical Biomarkers as Primary Endpoints; Novel data on lesson learned from using New Platforms and Patient Centric/Micro Sampling 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 Biomarkers Discovery, Development, Validation & Regulatory Approval and recent Controversial Issues.

Cutting-edge Mass Spec (MSA) methodologies in drug discovery/development applied to Novel Modalities, Protein Drugs, Biomarkers and Transgene; Automation/Robotic in Mass Spec; Innovative applications of Mass Spec in AAV Gene Therapy; Novel IA-MS developments for Bispecific T Cell Engager; Strategies & novel case studies for complex method development for next-generation of Small Molecules Covalent Inhibitors, Peptides, Oligonucleotides (mRNA, siRNA, LNP, nanoliposomes), Antibody Oligonucleotide Conjugates (AOC), Targeted Protein Degraders and Macrocylic/Large Molecules; Lesson Learned from Mass Spec Innovative Approaches and Technology Advancements for Dual-Payload ADCs by Integrated Bioanalytical Strategies to overcome instability issues; Strategies for improving throughput, sensitivity, resolution and multiplexed capabilities for Liposomal & Covalent drugs, Prodrugs and Low-abundance Peptides; Challenges in Quantitation of Encapsulated Nanoparticle Payloads; Developments in HRMS Increasing bioanalytical selectivity & sensitivity in presence of Isobaric Interferences; Measurement of biotherapeutics in in Formalin Fixed Paraffin Embedded Tumor; 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; Latest development to evaluate the impact of Drug Tolerance, Soluble Target and Interferences on a meaningful Clinical ADA Assessment and fit-for-purpose validation; Advanced/Innovative applications of Automation/Robotic, novel AI/ML-driven workflows and integration in DOE Optimization for LBA development; Strategies & novel case studies for complex method development for next-generation of Antibody-Based Therapeutics, Multispecifics/Complex Biotherapeutics, Drug Conjugates; High sensitivity Biomarkers Assays using Emerging Technologies (ET); Development of ultrasensitive ADA/NAb Assays; Cutting-edge advancements in LBA Critical Reagents/Positive Controls (CR/PC) generation and performance evaluation for Biotherapeutics, Gene Therapy and Biomarkers application; Data Driven Strategies for Implementation of PK/PD/ADA Singlicate Analysis lessons learned, regulatory feedback, and ongoing challenges; ADA Assay format and Positive Control (PC) selection for Oligonucleotides; Latest advances in the Method Development/Validation for LBA and Enzymatic Assays and Long-Term Maintenance to support Gene Therapy; Innovative approaches for bridging Highly Variable Critical Reagents Lots; 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), Cell Therapy (Immunogenicity/Cellular Kinetics assays for CAR T Cell Clinical Trials), Biomarkers Receptor Occupancy & Target Engagement (RO/TE) and Vaccines Cell-Mediated Immunity (CMI); Biofunctional Assays (BFA)Further development and implementation of AI/ML for High Parameter Cytometry applications and Data management; Recent approaches ELISpot & FluoroSpot development/validation and technology advancements; Biodistribution studies using advanced Multiparametric Flow Cytometry; Innovative approaches for overcoming the issue in the Isolation of Peripheral Blood Mononuclear Cells (PBMCs) and improving Unstable Flow Cytometry Assays; Modular High-Parameter Flow Cytometry; Advancements in Liquid Biopsies Biomarkers for disease monitoring; Newest innovations in Spectral Cytometry, Mass Cytometry, and Imagine Cytometry with a special focus on Spectral Flow Cytometry assays Current status of Single-cell Assays for High Dimensional Cytometry in clinical trials. Harmonized experience for RO Assays for complex Multidomain Biotherapeutics. 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 New Modalities for Regulatory Submissions; Implementation of AI/ML methodologies within Regulated Bioanalysis beyond Automation/Robotics; Enabling AI/ML in Regulated Bioanalytical Lab considerations for adoption and governance; Is NAMs impacting traditional Regulated Bioanalysis or not? NAMs applications in Preclinical Evaluation by improving human relevance while reducing dependence on traditional animal studies and Regulatory Expectations; Development of Piloted AI Reporting Tools and Case studies and current applications/considerations; 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; Applications of new Guidelines related to Regulated Bioanalysis: BA/BE Data Integrity; New insights on Bioavailability and Bioequivalence Studies in support of complex generic drugs; Emerging Technologies/Methods in Regulated Bioanalysis: Beyond ICH M10. Traditional KOL Industry/Regulators focused and highly interactive panel discussions on Regulated Bioanalysis Sampling, Validating, Analyzing & Reporting and recent Controversial Issues.

Methodologies to capture Peak Vector/Transgene Exposure in AAV therapies single administration with persistent transgene expression; Biodistribution studies to meet US FDA & EU EMA guidelines, long‑term persistence, tissue exposure, and safety risk; Innovative bioanalytical strategies to evaluate systemic gene expression for mRNA Vaccines, mRNA Cancer Vaccines & Replicating Oncolytic Virus therapies; Multiplex PCR and Sequencing approaches for genomic characterizing AAV capsid across multiple serotypes; Considerations on approved FDA wild-type AAV (wtAAV) vs novel gene delivery systems; Novel assays in support of gene editing CRISPR-Cas9 techniques; Development/characterization of Next Generation/High-performance CAR-T cells to overcome resistance and improve potency; Expanded application/validation of qPCR, dPCR and ddPCR assays for Genetic Multiplexing, Transgene and Target Gene Expression; Quantitative bias and false-positive in PCR-based methods used in Gene, Cell, Vaccine Therapies due to restriction enzyme–based fragmentation, length-dependent amplification efficiency, and PCR-induced artifacts; Cutting-edge Next-Generation Sequencing (NGS) applications in Gene, Cell, Vaccine Therapies; Strategies for NGS method development and validation; Advanced qPCR strategies for the quantification, normalization, monitoring inhibition of Transgene Expression in unwanted tissues and off-target resulting in toxicities; Use of ddPCR to measure specific Transgene Regulatory Elements (TREs) and mRNA transcript levels; Strategies for Viral Shedding Assay supporting Vaccine and Gene Therapy. Traditional KOL Industry/Regulators focused and highly interactive panel discussions on Di Gene, Cell, Vaccine Therapies Discovery, Development & Regulatory Approval and recent Controversial Issues.