At the EBF 19th Open Symposium, discuss your bioanalysis challenges

Intertek experts will present two scientific sessions focused on advancing bioanalytical decision-making across immunogenicity and biomarker applications.

In "Adaptive ADA Tiered Approach: A Better Fit for Therapies with Pre-Existing Antibodies," Issa Jyamubandi explores the challenges that pre-existing antibodies can create during anti-drug antibody (ADA) assessment. Using a therapeutic candidate with a high prevalence of pre-existing antibodies as a case study, the presentation examines adaptive immunogenicity testing strategies, assay development and validation considerations, and the value of Signal-to-Noise (S/N) reporting for improving data interpretation and differentiating treatment-induced responses from treatment-boosted pre-existing immune responses.

In "Did We Get the Context?", Debbie McManus discusses the importance of context of use in biomarker assay development and validation. Through a multi-assay case study incorporating biomarker, pharmacokinetic and immunogenicity assessments, the presentation demonstrates how integrated datasets can provide a more complete understanding of therapeutic impact. It also explores how unexpected findings can challenge initial assumptions, influence clinical strategy and support the development of fit-for-purpose approaches for future study phases.

Together, these presentations highlight practical approaches to overcoming complex bioanalytical challenges, improving data interpretation and generating meaningful insights to support drug development.

Interested in learning more? Get in touch and we'll send you copies of the presentations.