Value, Access, and Regulatory Strategy Conference

In the environment of an ongoing debate about access to new medicines vs. sustainability of health systems, multi-stakeholder engagement is a promising facilitator. The session will discuss how further dialogue between stakeholders could facilitate mutual understanding of the different perspectives and needs. The panel will explore how stakeholders could work collaboratively to build trust and find ways to address the residual uncertainties inherent to accelerated development and approval, such as conditional marketing authorization, of innovative medicines in areas of unmet medical need. How could outcome certainty be increased through a life cycle approach to evidence generation? How can we facilitate data generation throughout the lifecycle appropriate for different stakeholder purposes? How can we make sure that these processes are less sequential/more in parallel? Perspective of patients, regulators, HTA bodies, payers and industry will be provided.