PSI: Statistical Issues in the Use of Biomarkers


  • 25 September - 26 September 2013
  • Sunningdale Park, Ascot, Berkshire, SL5 0QE
  • Organiser: PSI - Statisticians in the Pharmaceutical Industry
  • E-mail:
  • Event Details

This two day course provides an introduction to the use of Biomarkers in pharmaceutical drug development. The course will provide an overview of general statistical principles in the development of biomarkers and biomarker-based classifiers and in the design and analysis of biomarker studies. Practical examples will be given in R.

About the presenters:

Athula Herath: Athula Herath is Statistical Director leading R&D Biostatistics group in Cambridge within MedImmune, the Translational Medicine Biotech Unit of AstraZeneca. Athula has been involved with biomarkers within the pharmaceutical settings for the past 15 years and speant a spell of 10 years as a University Lecturer prior to that. Athula obtained his PhD in statistical computing from Keele University.

Viswanath Devanarayan: Viswanath Devanarayan is Global Head of Exploratory Statistics at AbbVie and Adjunct Associate Professor of Statistics at Northern Illinois University. He has significant experience across the pharmaceutical industry including Lilly, Merck and Abbott and has given numerous invited presentations on assay methodologies and biomarker discovery with both pre-clinical and clinical applications. He has coauthored several important position papers on topics such as biomarker method validation and clinical biomarker qualification.

Marc Buyse: Marc Buyse studied biostatistics at the Harvard School of Public Health (USA). He is the founder of the International Drug Development Institute (IDDI), a company providing data services for clinical trials and of CluePoints, a company dedicated to statistical monitoring of clinical trials. He is Associate Professor at the University of Hasselt in Belgium. Marc is widely published on the clinical evaluation of biomarkers and the development of surrogate endpoints, see

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