October 18, 2012

Developing and Applying Biomarkers in Early Phase Clinical Trials

Developing and Applying Biomarkers in Early Phase Clinical Trials

As the pharmaceutical industry embraces the concept of personalised medicine, there is an increased interest in the application of biomarkers earlier in the drug development pipeline. This can pose significant challenges for both Pharma and diagnostics companies.

Almac has significant experience in the discovery of single target and multivariable signature based biomarker assays in a pre-clinical setting from both cell line and xenograft models and translating them into analytically validated clinical tests that can be used to enrich clinical trials from as early as phase I.

This webinar presents an overview of some of the key components involved in developing such products including:

• Platform selection
• Optimising tests for FFPE tissue
• Assay migration (tissue type and/or platform)
• Determination of assay analytical parameters to CLIA standards
• Biomarker clinical trial design and management
• Clinical assay delivery

Pharma and biotechnology companies worldwide, particularly

• Senior scientists and clinical trials executives involved in companion diagnostics and biomarker strategies

Dr. Timothy Davison is VP of Bioinformatics and Biostatistics within Almac Diagnostics. In this role, he leads a team of scientists, supporting technology benchmarking and the development of diagnostic, prognostic and predictive tests. Dr. Savison received his bachelor of Applied Mathematics from the University of Waterloo and Ph.D. in Medical Biophysics from the University of Toronto. He spent 2 years as a post-doctoral research scientist, joint appointed to the Max Planck Institute for Biological Cybernetics, Department of Empirical Inference for Machine Learning and Perception, and the Institute for Developmental Biology, Department of Molecular Biology.

Dr. Susan Farragher is an Operations Manager in Almac Diagnostics since 2010. She received her Ph.D. in Molecular Genetics from the University of Ulster Coleraine, Northern Ireland in 2002. Dr. Farragher has focused on driving laboratory process improvements and efficiencies including developing methods requiring FFPE tissue for use in genomic applications. Her current work includes development of clinical assays from assay design and optimization through to delivery of a 'locked down' assay. Dr. Farragher is also a General Supervisor in the clinical laboratory supervising the day to day work of all CLIA certified laboratory testing.

Almac partners with the biopharmaceutical industry to provide biomarker discovery and development solutions ranging from pre-clinical biomarker discovery, through to full companion diagnostic development, biomarker clinical trial management and clinical test delivery from our CLIA lab.

We have an expert team with a wide range of experience. We have a portfolio of proprietary discovery arrays and extensive experience and expertise working with formalin fixed paraffin embedded (FFPE) tissue. We utilise this expertise, experience and innovative technology developing diagnostics for our partners and in the development of our own pipeline of molecular diagnostics.