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
- Develop a better understanding of key challenges and critical steps to understanding immunogenicity to maximize success in clinical development programs.
- Gain an understanding of the immunogenicity challenges across disciplines outside of your own expertise.
- See how the challenges of immunogenicity relate to each stage of the drug development process.
- Prepare to work with development teams to troubleshoot unexpected immunogenicity problems.
- Understand regulatory requirements and how to navigate regulatory submissions when immunogenicity challenges arise.
Committee
Chad Briscoe, Ph.D., BioAgilytix
Jim McNally, Ph.D., BioAgilytix
Johanna Mora, Ph.D., Bristol Myers-Squibb