View Detailed Program of Full-Day Specialized Workshops

View Full-Day Specialized Workshop M1 Detailed Program – Sep. 27, 2021: 7am to 5:30pm

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

View Full-Day Specialized Workshop M2 Detailed Program – Sep. 27, 2021: 7am to 5:30pm

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

View Full-Day Specialized Workshop T1 Detailed Program– Sep. 28, 2021: 7am to 5:30pm

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

View Full-Day Specialized Workshop Th1 Detailed Program – Sep. 30, 2021: 7am to 5:30pm

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

View Full-Day Specialized Workshop Th2 Detailed Program – Sep. 30, 2021: 7am to 5:30pm

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

View Full-Day Specialized Workshop F1 Detailed Program – Oct. 1, 2021: 7am to 5:30pm

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

View Full-Day Specialized Workshop F2 Detailed Program – Oct. 1, 2021: 7am to 5:30pm

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

Agenda at a Glance Agenda at a Glance