Seven full-day Specialized Workshops Throughout the Week

In addition to the sequential 3-DAY Main Workshop program, 7 full-day Specialized Workshops will spread throughout the week to give you many choices to combine Main Workshop DAYs with these Specialized Workshops based on your specific track of interest and learning needs.

Monday Specialized Workshops - April 13, 2026: 7am to 5:45pm

  • Full-Day Specialized Workshop M1:
    Biotherapeutics & Biosimilars Immunogenicity Assessment & Clinical Relevance - Latest Advances, Challenges and Solutions from Internationally Recognized Key Opinion Leaders

    Cutting-edge knowledge in harmonization of ADA/NAb TestingReporting, 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 Oligonucleotide & Peptides; Understanding the Emerging Approaches for the Immunogenicity Assessment of Next-Generation Biotherapeutics; Lesson Learned on Integrated Summary of Immunogenicity (ISI); Advanced ADA-Domain-Characterization of Complex/Novel Biotherapeutics; 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 RelevanceTraditional KOL Industry/Regulators focused and highly interactive panel discussions on Immunogenicity Reporting, Submissions Outcome and recent Controversial Issues.

  • Full-Day Specialized Workshop M2:
    Biomarkers Discovery, Development, Validation & Regulatory Approval - Latest Advances, Challenges and Solutions from Internationally Recognized Key Opinion Leaders

    Novel Translational Biomarkers Identification with cutting-edge Multiplex/OMICs/High-Plex by Emerging Technologies, LBA & Mass Spec and challenges in Data Integration; Application of Fit for Purpose Validation (BAV) with the 2025 US FDA Guidance BMV for Biomarkers; Development IVD/CDx assays for AAV Gene Therapy Patient Selection/Stratification and Drug Response Monitoring; Issues with IVD pre-analytical phase; 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 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 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 Biomarker Assays, BAV, IVD, CDx, LDT and recent Controversial Issues

Tuesday Specialized Workshop - April 14, 2026: 7am to 5:45pm

  • Full-Day Specialized Workshop T1:
    Mass Spectrometry Assays - Latest Advances, Challenges and Solutions from Internationally Recognized Key Opinion Leaders

    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), Protein Degraders and Macrocylic/Large Molecules/ADC; Lesson Learned from Mass Spec Innovative Approaches and Technology Advancements by using 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; Multiple Nanoflow & Ion Mobility Spectrometry (IMS) innovative applications; Increasing bioanalytical selectivity & sensitivity in presence of Isobaric 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.

Thursday Specialized Workshops - April 16, 2026: 7am to 5:45pm

  • Full-Day Specialized Workshop Th1:
    Ligand-Binding Assays - Latest Advances, Challenges and Solutions from Internationally Recognized Key Opinion Leaders

    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 ultrasensitive ADA/Nab Assays; Cutting-edge advancements in LBA Critical Reagents/Positive Controls generation and performance evaluation for Biotherapeutics, Gene Therapy and Biomarkers application; 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; Understanding the unique challenges of critical reagent generated for novel modalities and for Emerging Technologies; Application of Discovery Bioanalysis solution to Regulated BioanalysisTraditional KOL Industry/Regulators focused and highly interactive panel discussions on Discovery/Regulated Ligand-Binding & Enzymatic Assays applications and recent Controversial Issues.

  • Full-Day Specialized Workshop Th2:
    Cell-Based Assays - Latest Advances, Challenges and Solutions from Internationally Recognized Key Opinion Leaders

    Cutting-edge CBA methodologies in drug discovery/development in Cellular Immunogenicity (NAb Assays), Cell Therapy (Cellular Kinetics & PK CAR T Cell Clinical Trials), RNA Therapies, Biomarkers (Receptor Occupancy & Target Engagement) and Vaccines (Cell-Mediated Immunity/Functional Assays); Further development and implementation of AI/ML for High Parameter Cytometry applications and Data management; Recent approaches ELISpot & FluoroSpot development/validation and technology advancements; PrimeFlow methodology for cell-specific simultaneous Transgene RNA/Protein bioanalysis; Innovative approaches for overcoming the issue in the Isolation of Peripheral Blood Mononuclear Cells (PBMCs) and improving Unstable Flow Cytometry Assays; Advancements in Liquid Biopsies Biomarkers for disease monitoring; Newest innovations in Spectral Cytometry, Mass Cytometry, and Imagine Cytometry; Current status of Single-Cell 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.

Friday Specialized Workshops - April 17, 2026: 7am to 5pm

  • Full-Day Specialized Workshop F1:
    Regulated Bioanalysis Sampling, Validating, Analyzing & Reporting - Latest Advances, Challenges and Solutions from Internationally Recognized Key Opinion Leaders

    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; Development of Piloted AI Reporting Tools and Case studies and current applications/considerations; 2025 FDA BMV for Biomarkers & Regulatory Inspections; ICH M10 Cross Validation - was Industry/Regulators’ harmonization reached? What’s the current status of Regulated Bioanalysis in China? 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; Validation of Emerging Technologies/Method 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.

  • Full-Day Specialized Workshop F2:
    Gene, Cell, and Vaccine Therapies Immunogenicity & Technologies - Latest Advances, Challenges and Solutions from Internationally Recognized Key Opinion Leaders

    Recent Advances in the Immunogenicity Assessment & Clinical Relevance for Gene, Cell, Vaccine Therapies based on lesson learned from Regulatory Submissions; Advice on putting together the Integrated Summary of Immunogenicity (ISI) and challenges in applying the Current Paradigm for Immunogenicity Testing for Gene & Cell Therapies; Use of Novel Vectors (Viral & LNP) and Regulatory Feedbacks on TAb/NAb Assays; Fit-for-Purpose Validation for Immunogenicity T Cell Assay and progress in the development and characterization of Next Generation CAR-T; Comprehensive Cellular Kinetics Strategy; 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) and Nanostring applications in Bioanalysis and how the bioanalytical labs are handling the method development and validation for NGS and Nanostring; Understanding & misunderstanding in qPCR/ddPCR Cross-Validation & Data Comparability; 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.



Agenda at a Glance Agenda at a Glance