Overcoming Assay Harmonisation & Validation Challenges to Ensure Cross-Trial Comparability & Regulatory Acceptance

Eliminate the variability and comparability issues that undermine biomarker confidence across studies. This hands-on workshop equips you with frameworks for selecting validated assays, establishing harmonisation protocols across multiple vendors and platforms, and building regulatory-grade validation packages. Walk away with actionable strategies to reduce interlab variability, leverage IVD-approved assays, and create biomarker data sets that withstand regulatory scrutiny and enable meaningful historical data comparisons.

Workshop Highlights Include:

• Dissection of a failed biomarker programmes, examining the root causes, financial impact, and specific corrective actions that could have prevented the failure, providing cautionary lessons you can apply immediately
• Interactive group discussion on navigating the regulatory landscape in Europe versus US, understanding when validated assays are mandatory versus when research-use-only assays are acceptable, and strategies for transitioning from exploratory to regulatory-grade biomarkers
• Approaches to managing the competitive multi-vendor assay landscape, where differing platforms complicate standardisation, including the use of round-robin studies, shared reference materials, and harmonisation consortia
• Quality control strategies to ensure reproducibility across batches, sites, and time when deploying ultrasensitive biomarkers in multi-site global trials, including the establishment of internal standards and calibration procedures to maintain assay performance throughout a clinical programme

Speakers:

Nanh Nguyen

Translational Medicine Biomarker Lead

UCB