Webinar Description:

In this webinar, QPS will discuss the different considerations for preclinical and clinical assays, as well as the current QPS fit-for-purpose approach for the Anti-drug Antibody (ADA) assay validation and bioanalysis of samples from preclinical studies.

The monitoring of ADA is an important part of preclinical and clinical studies, as it is well known that protein-based drugs can trigger an immune response. For clinical studies, the formation of anti-drug antibodies can be a safety concern, and both EMA and FDA have published regulatory requirements for ADA assays.

Initially, the ADA analysis of preclinical study samples was approached very similar to that of clinical study samples. However, in the last few years it is more apparent that the ADA response in preclinical species has no predictive value for the immunogenicity in human. In fact, it is merely intended to identify ADA positive animals in the study and evaluate the impact of the presence of ADA on the PK data. Given the difference in objective of ADA analysis in preclinical and clinical studies, the efforts on method validation and ADA bioanalysis can be reduced for preclinical species.

Learning Objectives:

• Understand how the monitoring of Anti-drug Antibodies (ADA) is an important part of preclinical and clinical studies and understand the immune response safety concerns.
• Discover the different considerations for preclinical and clinical ADA assays.
• Learn about the current QPS fit-for-purpose approach for the ADA assay validation and bioanalysis of samples from preclinical studies.

Speaker:

Monique Putman, Ph.D.
QPS Competency Director
Translational Medicine

Monique Putman joined QPS Netherlands in 2002 and is currently Director Translational Medicine. In this position, Monique serves as manager of three teams for the development and validation of ligand binding assays, cell-based assays, activity assays and FACS assays to support the development of biological drugs. Prior to joining QPS, Monique held a position of Staff Scientist and Biological Safety Officer at the Hercules European Research Center (Barneveld, the Netherlands). Monique studied Food Technology at the Wageningen University (The Netherlands) and received her PhD in the Molecular Microbiology Group of the Groningen Biomolecular Sciences and Biotechnology Institute (GBB) of the University of Groningen, The Netherlands.

Cost: No Cost!