Biomarkers and Precision Medicine Community (BPMC)

Open Scientific Discussion (OSD) hosted by the AAPS Therapeutic Product Immunogenicity (TPI) and Biomarkers and Precision Medicine (BPM) Communities on February 7^th, 12 - 1 pm ET on the following topic:

Characterizing CD4 T Cell Immune Responses (Part 1)

·         Why is studying CD4 T cell responses important during preclinical immunogenicity risk assessment?

·         What are the features and challenges of different CD4 T cell assays?

·         How to choose and implement a CD4 T cell assay that is fit-for-purpose?

Discussion Leaders:

Jochem Gokemeijer (BMS), Bernard Maillere (CEA), Sophie Tourdot (Pfizer), and Laurent Malherbe (Lilly)

Organized by:  Yi Wen (Lilly), Vibha Jawa (BMS), Carmen Fernández-Metzler (PharmaCadence) and Karen Quadrini (Prothena Biosciences)

Note: Characterizing CD4 T Cell Immune Responses (Part 2) will occur on February 21^st, 12 - 1 pm ET featuring regulatory perspectives, relevance, and inclusion of other assays for holistic immunogenicity risk assessment