The Importance of Biomarkers for Early Drug Development

In this presentation, I will first describe the early drug development process comprising the pre-clinical phase, phase I to establish safety, tolerability and a good understanding of pharmacokinetics, and phase II that aims at providing a proof of concept for a given indication. I will then review different types of biomarkers that are of high relevance for drug development in neuropsychiatric disorders including (1) pharmacodynamic biomarkers that allow demonstrating modulation of brain activity, (2) biomarkers that quantify specific aspects of the disease pathophysiology or symptomatology, and (3) biomarkers that could be used to identify sub-populations that respond to a specific treatment. I will illustrate the different types of biomarkers using specific examples from our work at Roche. The goal is to convey the importance, the impact, and the challenges of using biomarkers in early drug development from an industry perspective.