Topics to be Covered:

• Current regulatory guidance
  
• NAb assay strategy – Immunogenicity risk assessment
  
• Special focus on assay format selection – Mechanism of action-based approach
  
• Validation and implementation of NAb assays
  
• Relevant case studies
  

Topics to be Covered:​

• Types of Interferences: Soluble Target, Drug and Matrix
  
• Immunogenicity Assay Designs and Susceptibility to Interference
  
• Competitive Ligand-Binding Immunoassays Bridging Immunoassays
  
• Cell-Based Immunoassays Mitigation Strategies
  
• Sample Pre-Treatment BEADACEBEHD
  
• Heat Inactivation
  
• Case Studies
  

Topics to be Covered:​

• Tiered testing strategy: Basic issues regarding screening, confirmatory, and titer assays
  
• ADA assay validation strategies: Experimental design to execute a validation
  
• Step-wise process for calculating different types of cut-points
  
• Practical challenges for the in-study implementation of cut-points
  
• Case studies related to the implementation of validation and study-specific cut-point
  

Topics to be Covered:​

• Overview of the IEDB and CEDAR database structure, content, and how to search for epitope-related data
  
• Introduction to the classic Analysis Resource: tools for epitope analysis and prediction
  
• Walkthrough of the Next-Generation Tools to create prediction pipelines for advanced scientific research
  
• Live demonstrations showing how to apply all IEDB resources to real-life scientific problems, including predicting cancer epitope
  
• Practical guidance on integrating IEDB resources into your own research projects and experimental design

Benefits of Attending:

• Gain a comprehensive understanding of how to navigate and extract data from the IEDB and CEDAR database
  
• Learn to use both classic and next-generation epitope prediction tools to enhance your research capabilities, including predicting cancer epitopes and de-immunizing protein antigens
  
• See real-world examples of how IEDB tools can be applied to address complex immunological research questions
  
• Develop the skills to build and customize epitope prediction pipelines for your specific research needs
  
• Leave with practical knowledge and confidence to incorporate IEDB resources into experimental planning and data analysis
  

Background:

Information relevant to the assessment of the impact of undesirable immunogenicity of therapeutic proteins on overall clinical benefit vs. risk balance is distributed across many different sections of the regulatory dossier. This has made it difficult for regulatory reviewers to locate the requisite data. Moreover, essential background information to describe the intrinsic immunogenic potential of the molecule, and how extrinsic factors (product quality, patient variables, dose regimen, etc.) might interact to influence clinical manifestations, is often missing. Although there might be valid reasons for applying a particular strategy for evaluating immunogenicity, the sponsor’s rationale is often not clearly explained. For this reason, recently issued FDA and EMA guidance has recommended submitting integrated summary documents in regulatory submissions with the objective of collating the essential information required by the regulatory assessor.

Who Should Attend:

This short course is relevant to anyone who is involved in generating and compiling the input data for immunogenicity-­related sections of regulatory dossiers, including CMC, bioanalytical, non-­clinical, clinical, and regulatory specialists.

Topics to be Covered:

• Regulatory expectations
  
• The iterative process
  
• Risk assessment and study planning
  
• Identifying relevant information for the ISI
  
• ISI structure, level of detail and analysis, suggestions for presenting the data