Measurement and Understanding of Immune Response in Context of Clinical Development

Starts:  May 24, 2022 09:00 (ET)
Ends:  May 25, 2022 17:00 (ET)
Associated with  AAPS Community

Understand the immune response as a clinical development team is required to do in the development of biologics. This workshop covers key aspects of the assessment of immune response considerations in discovery and pre-clinical studies, from the clinical stages through approval. It is organized along the phases of drug development and uses case-study based presentations to demonstrate challenges and best practices. Discuss the current thinking on hot topics, including the appropriate approach for assessments in non-clinical trials; developing immunogenicity assays for novel constructs; developing immunogenicity risk assessments for clinical development; and current expectations for assay validations. 

Learning Objectives

  1. Develop a better understanding of key challenges and critical steps to understanding immunogenicity to maximize success in clinical development programs.
  2. Gain an understanding of the immunogenicity challenges across disciplines outside of your own expertise.
  3. See how the challenges of immunogenicity relate to each stage of the drug development process.
  4. Prepare to work with development teams to troubleshoot unexpected immunogenicity problems.
  5. Understand regulatory requirements and how to navigate regulatory submissions when immunogenicity challenges arise.



Chad Briscoe, Ph.D., BioAgilytix

Jim McNally, Ph.D., BioAgilytix

Johanna Mora, Ph.D., Bristol Myers-Squibb

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