Given the high unmet medical need, the potential benefit to the patients and the limited therapeutic ‘window of opportunity’, there is an imperative to provide access to promising products to patients in an expedient manner. With a number of potential breakthrough therapies in the pipeline, there is a high need to discuss the type and the amount of evidence that can be collected during clinical development and the fact that a greater proportion of the evidence will need to be generated post-launch. In this session we want to focus on questions such as: What will future evidence generation strategies look like? What are the consequences of these developments for regulatory and HTA decision making? The speakers will focus on the types of evidence that different stakeholders need in their decision-making.