Clinical Trial Assay Development and Validation – Strategies for Success

Featured Speaker: Dr Cheryl McFarlane, Assay Development & Validation Manager

Molecular biomarkers offer tremendous potential to classify patients into subgroups of relevance for prognostic & predictive utilities.  However, there are many challenges and considerations in translating a biomarker to a molecular diagnostic test (Clinical Trial Assay). When defining the intended use of novel biomarker, decisions including specimen collection, molecular content and platform selection can have a significant impact on a biomarker program.

A strategic approach to the development & analytical validation of clinical trial assays at each stage of clinical validation ensures the highest quality molecular data is acquired in the most efficient way whilst minimising the potential risk of product redesign for Biopharma companies.

Almac Diagnostic Services has substantial experience of analytical validation across all stages of diagnostic test development from utilisation in early proof of concept trials through to IVD Companion Diagnostic (CDx) tests, often consulting to help guide Biopharma companies through the process.

This talk will highlight a series of case studies to explore the strategic considerations at each stage of the development & validation journey to ensure that assays are both robust and compliant with appropriate global regulatory frameworks for prospective clinical trial stratification.

Takeaways:

Participants will learn about:

• Key considerations in the development & validation of CTAs for clinical stratification
• The importance of adequate specimen collection & stabilisation
• Major factors influencing platform selection
• The requirement of bridging studies and lessons learned
• Challenges of demonstrating adequate analytical performance of panels
• Considerations for data analysis pipelines