In addition to the Sequential 3 Main Workshop Days, 7 full-day Specialized/Training Sessions will spread throughout the week to give you the flexibility to choose different combination of Workshop Days and Specialized/Training Sessions based on your specific track of interest and learning needs.
Training Session M1: 7am - 5:30pm
"Advanced Biomarkers Development & Troubleshooting by LBA & Flow Cytometry: Challenges from Exploratory to Clinical/Confirmatory Biomarkers, Fit-for-Purpose, Context of Use and New Platforms"
From Discovery/Exploratory Biomarkers to Clinical/Confirmatory Biomarkers, actual challenges in developing and implementing biomarkers assays in different phases of drug discovery/development by embedding the Fit-for-Purpose (FFP), Context of Use (COU) and new platforms in real-life situations
Specialized Session M2: 7am - 5:30pm
"BMV Guidance Day: Interpretations & Training on ICH M10 before its Adoption; Audits Outcome using 2018 FDA; Transition from Local Guidelines to ICH M10 with Gap Analysis on Controversial Issues"
How can you be prepared for the transition from local FDA, EMA, MHLW, ANVISA Guidance/Guidelines to ICH M10? What do you need to do for the ICH M10 adoption & Global Harmonization of Bioanalytical Guidance? An in-depth gap analysis on controversial BMV issues after the public consultation of the ICH M10
Training Session T1 for LBA scientists: 7am - 6:00pm
"Large Molecules Method Development by LBA: Solving Challenges with Innovative Approaches on Critical Reagents, Learning from Vaccine Assays, Multi-Domain Biotherapeutics, Emerging Technologies"
What’s new in Critical Reagents and impact on method development? What can we learn from Vaccine Assays experience? How Multi-Domain Biotherapeutics (MDB) are changing traditional method development strategies? How can Emerging Technologies (ET) help in method development?
Training Session T2 for Flow Cytometry scientists: 7am - 6:00pm
"Innovation in Flow Cytometry, Mass Cytometry, and Imaging Cytometry to Solve Complex Method Development Issues in Drug Discovery/Development and Clinical Applications: What’s New for Bioanalytical Labs using Cytometry for Biomarkers, Immunogenicity, Cell Therapy and Cellular and Immuno-Oncology Assays?"
Learn from advanced case studies on Fluorescence-Based Flow Cytometry reduction in the complexity, increase in automation & sensitivity and capacity to detect rare populations. Learn the major advantages & challenges in using Mass Cytometry (CyTOF) & Imaging Cytometry vs traditional Flow Cytometry. How can your assay be improved by extending Flow Cytometry capabilities to high-throughput / high-content, single-cell assays, unmet antibody specificities in a single sample and without spillover between channels?
Training Session Th1 for LCMS scientists: 7am - 6pm
"Small Molecules, Oligos, Peptides, SM Biomarkers Method Development by Chromatographic Assays: Solving Challenges with Innovative Approaches on Sensitivity & Selectivity, Unstable/Sticky Compounds; Column Chemistry, Orthogonal Separations, Tissue bioanalysis"
New level of Sensitivity & Selectivity (S&S); “Very” Unstable Metabolites/Pro-drugs how to catch them;
Back to basic with adsorption of very “sticky” Compounds; Novel column chemistry and orthogonal separations. Novel strategies for tissue bioanalysis
Specialized Session F1: 7am - 5:30pm
"Advanced Immunogenicity Day: Implementation of 2019 FDA Immunogenicity Guidance, NAb Assays, ADA Validation Reporting, Immunogenicity Risk Assessment, Regulatory Feedbacks & Controversial Issues"
Implementation of the Guidance after a year from its issuance; Current approaches on Nab (Cell-Based and Bridging) Assays; ADA Validation Reporting; Immunogenicity Risk Assessment and impact on bioanalytical strategy; Regulatory Feedbacks on submitted studies; Inspections/audits outcomes based on the new Guidance; and Case Studies on successfully implementation in compliance with the new Guidance and avoid observations and 483s
Specialized Session F2: 7am - 5:30pm
"Cell & Gene Therapy Bioanalysis: Recent Advancements and New Frontiers for Bioanalytical Labs on Flow Cytometry, qPCR, ELISPOT, Regulatory Requirements, CAR-T and CRISPR Assays Case Studies"
Catching up with “explosion” of recent developments Cell & Gene Therapy Bioanalysis with specific focus on Flow Cytometry, qPCR, ELISPOT and Regulatory Requirements. Ongoing research in CAR-T and CRISPR Bioanalytical, Biodistribution Biomarkers and Immunogenicity Case Studies. Strategies to be prepared to handle the increasing demand of drug discovery/development bioanalytical data in support of ongoing and future research
