Evaluating Potential Immunogenic Adverse Events and Characterizing Anti-Drug Antibodies, and Their Impact on Potential Immunogenic Adverse Events

Time: 1:00 pm
day: Pre-Conference Day Track B PM


This hands-on workshop offers attendees clear examples for characterizing anti-drug antibody (ADA) outcomes in clinical trials and assessing their impact on significant clinical results in line with regulatory expectations and immunogenicity guidelines. Participants will collaborate in teams to discuss these examples, presenting summaries of their discussions on data analysis, result interpretation, and communicating key messages regarding immunogenic risk. This includes integrating immunogenicity clinical data for dossiers, comprehending how immunogenic response risks are reported from trials, identifying potential immunogenic adverse events, and ultimately securing the safety of treated individuals.

Join us to learn about:

  • Clinical trial design: how and when to collect samples to characterize anti-drug antibody (ADA). How to analyze and report the results of ADA from clinical trials, in alignment with regulatory agencies immunogenicity guidelines
  • Statistical Analysis Plan: examples on how to assess the impact of ADA on clinically meaningful outcomes
  • Collection of Data: how to collect Injection Site Reactions (ISR) and/or Infusion Related Reactions (IRR) for each administered dose, and how to use the data in the programmed algorithms for analyses and reporting
  • Medical Evaluation: Utilizing standardized assessments to evaluate all safety events, identify if they are potential acute or delayed immunogenic reactions against the therapeutic drug
  • Assessment of clinically significant impact by presence of ADA on potential Immunogenic Adverse Events
  • Identify the risk of potential Immunogenic Adverse Events and their significant impact on clinical outcomes for each program to inform risk-benefit considerations