Lectures and seminars SFOepi Seminar Series in Biostatistics: José Sánchez

Abstract: Drug development is a long complex process starting with the discovery of a molecule that engages with a target and ends, typically several years later, with the approval for marketing by a health authority. The process is divided in 4 phases: pre-clinal and phases I to III where the drug discovery is done in the pre-clinical phase and the marketing follows a successful phase III trial. In this talk I will present a general overview of the drug development stages, their goals and the statistical aspects and challenges around their design and analysis.

About the speaker: Dr José Sánchez is a Director of Biometrics at AstraZeneca where he leads a team of statisticians working with the design, conduct and analysis of phase I and II clinical trials within the Cardiovascular, Renal and Metabolic (CVRM) diseases area. He has worked across the whole drug development pipeline and is engaged with several internal groups working in the innovation and optimisation of clinical trials, with special interest in mixed models and hierarchical models. José has represented Sweden in the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and is an adjunct senior lecturer at Chalmers University of Technology where he teaches a course in Data Science for Biomedicine.