Immunogenicity Risk Assessments & Bioanalytical Considerations during Preclinical Development of Cel
Immunogenicity Risk Assessments & Bioanalytical Considerations & Clinical Relevance for Development of Cellular Therapies
Presented by the IQ Novel Modalities Working Group
Sponsored by IQ Translational and ADME Sciences Leadership Group (TALG) & IQ Clinical Pharmacology Leadership Group (CPLG)
This webinar intend to summarize the developability considerations associated with preclinical development of cell-based therapies. The talk will cover the potential risks associated with the constructs, tools used to mitigate the risks and development of a robust bioanalytical strategy to measure and monitor the humoral and cellular immune responses. A review of the current landscape of ongoing regulatory submissions as well as case studies using approved therapies will be presented. The talk will also provide best practices/approaches to adopt for clinical trials and sample collections and identify the current gaps and potential solutions to address such gaps. Apart from conventional cell-based therapies using autologous cells, the current knowledge of next generation of cells like allogeneic cells and NK and STEM cell-based therapies will also be presented.
- Jochem Gokemeijer, Bristol Myers Squibb
- Weifeng Xu, Merck & Co., Inc.
- Nanda Balasubramaniam, Bristol Myers Squibb