Statistical Validation of Biomarkers for Use in Early Clinical Development and Biotechnology

Featuring Ziad Taib, Statistical Science Director at AstraZeneca

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Abstract: 'Statistical Validation of Biomarkers for Use in Early Clinical Development and Biotechnology'

Despite the fact that a large number of candidate biomarkers have been identified by biologists during the last decades, very few of these has made it all the way to clinical practice. One of the reason for this, is lack of proper validation on a level that is satisfactory to the authorities and the medical community. Biomarker validation, viewed as a confirmatory process aiming at validating a specific biomarker for a certain purpose, should ideally be based on proper statistical models and methodology. In this presentation, we will consider such validation methods based on type of biomarker and discuss several associated pitfalls from an early clinical biometrics perspective.

About the speaker:

Ziad Taib is a Global product statistician at Astrazeneca, R&D and an adjunct Professor of Biostatistics at Chalmers University of Technology, Gothenburg, Sweden. He joined the pharmaceutical industry in the year 2000 after over 10 years teaching and research in academia. Since then, he has occupied several projects- and line management positions in AstraZeneca. He is currently mostly involved within the Respiratory and Inflammation therapeutic areas within Early Clinical Biometrics. Among his current areas of interest are: statistical methods related to the use of Biomarkers in clinical trials as well as stochastic modelling in early phase clinical trials. His earlier research was centered on stochastic modelling in biology and medicine, e.g. models for spread of infectious diseases. He is currently the president of the International Biometric Society's Nordic Baltic Region.

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