In addition to the sequential 3-DAY Main Workshop program, 7 full-day Specialized Workshops spreads 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.
Full-Day Specialized Workshop M1:
"ADA/NAb Guidance Day: Recent Advancements in the Harmonization of Immunogenicity Testing & Reporting"
Industry/Regulators focused and interactive discussions on Immunogenicity Issues/Audits/Submissions outcome, controversial Issues on US FDA/EU EMA Immunogenicity Guidance/Guideline, finalization of NAb Assays Harmonization recommendations with multiple Agencies, ADA Validation Reporting, Immunogenicity Risk Assessment and impact on bioanalytical strategy, regulatory observations and 483s on ADA Assay Validation, Immunogenicity Assays for Multi-Domain Biotherapeutics (MDBs) & Bispecific drugs, Comparability of ADA assay performance/results
Full-Day Specialized Workshop M2:
"BMV Guidance Day: Recent Issues in Bioanalytical Method Validation Guidance/Guidelines and Regulated Bioanalysis for Small and Large Molecules"
Industry/Regulators focused and interactive discussions on Audits/Inspections/Submissions outcome, gap analysis on new Controversial Issues, interpretation and training on BMV Guidance/Guideline by Chromatographic and Ligand Binding Assays. In depth discussions on Evolving Regulated Bioanalysis Standards and Regulated Bioanalysis of Complex PK Assays. Special focus on Patient-centric Approaches in Regulated Bioanalysis
Full-Day Specialized Workshop T1 for Mass Spectrometry scientists:
"Mass Spectrometry of Biotherapeutics, Protein Biomarkers and Transgene Proteins: Recent Issues from Discovery to Regulatory Submissions"
Current advancement in Hybrid Assay (IA-MS), innovative Triple Quad sensitivity gain, HRMS (QTOF & Orbitrap) method development approaches, Hybrid assay Bioanalytical Assay Validation for regulatory submission, Transgene Protein bioanalysis & Tissue Assays for Gene Therapy, Latest Mass Spec Approaches and Technology Advancements for quantification of protein Therapeutics/Biomarkers, challenges for Sample Preparation & Immunoaffinity, HRMS bioanalysis for Intact Large Molecule, Biotherapeutics Biodistributions
Full-Day Specialized Workshop Th1 for LBA scientists:
"Conventional & Novel Critical Reagents: Recent Issues in Development and Management for Established/Emerging Technologies/Modalities"
New tools to support Robust Immunoassays, Bridging Highly Variable Critical Reagents lots, Critical Reagents from Phage-Display Technology vs conventional Animal-Based Critical Reagents, dealing with Critical Reagents Discontinued by Vendors, Critical Reagent for New Modalities and new Assays Platforms, High Affinity Critical Reagents and Relation to Assay Function, Aptamers/Affimers/Novel Non-Antibody Critical Reagents, Vaccine advanced experience in Critical Reagent Life Cycle Management/Bridging, Selection of Clinically-Relevant Positive Control for ADA assays
Full-Day Specialized Workshop Th2 for Cytometry scientists:
"Cytometry Innovation Day: Novel Techniques & Advanced Approaches in Cytometry"
High Dimensional/High Parameter Flow Cytometry, new applications of Automated Gating, Advancements in Full Spectrum/Spectral Cytometry, Novel applications of Mass Cytometry, overcoming the barriers in implementation of Imaging Cytometry, Advanced Flow Cytometry for Vaccine application, single‐cell multimodal omics & Highly Multiplexed Flow Cytometry
Full-Day Specialized Workshop F1:
"Biomarkers Development & Translational Science: Recent Issues from Discovery to Regulatory BAV Guidance"
Innovation in Biomarkers Assays Development in Discovery & Development. Harmonized Biomarker Assay Validation (BAV) Guidance and regulatory approval questions, advanced method development from Discovery multiplex/OMICs to Clinical primary/secondary endpoints & patients stratification, Ultra-sensitivity platforms pros/cons, best time to initiate CDx, complex assay Parallelism assessment, insights on when CLIA /ISO/GLP, challenges in Sample Collection. Focus on advancements in Exploratory Biomarkers & Target Engagement (TE) Biomarkers Assays
Full-Day Specialized Workshop F2:
"Gene Therapy, Cell Therapy and Vaccine Bioanalysis: Recent Issues in Scientific Advancements and Regulations"
US FDA & EU EMA expectations for Gene Therapy & Cell Therapy Immunogenicity Monitoring, Anti-AAV assays for patient enrollment/stratification in CAP/CLIA or/and GLP/GCP labs, need/not need to be a CDx, Assay format selection for CAR-T ADA Assay and Triplex CAR-T NAb Assay, Bioanalytical methods for CRISPR/Cas9 genome editing bioanalysis, Vaccine Bioanalysis and Harmonization on validation for Vaccine Assays, qPCR/ddPCR Bioanalytical Method Validation (BMV) and QC to monitor performance for Gene Therapy & Vaccine, Acceptance criteria for Biodistribution/Shedding Assay, Cell-based Aassays for Vaccines, current industry standards for CAR-T evaluation for Flow Cytometry & ELISpot assays
See Below Agenda at a Glance to find out how to combine these Full-Day Specialized Workshops with Main Workshop DAYs: