Regulatory decisions are of necessity based on incomplete data Traditional drug licensing approaches are based on binary approval decisions which reduce the uncertainty of an experimental therapy to a fully vetted, safe, and efficacious market authorization. Adaptive licensing (AL) proposals would contrast this precedent providing iterative phases of data gathering followed by regulatory evaluation and would allow the approval process to align more closely with patient needs such as timely access to new technology and the information required to inform medical decisions. Adaptive licensing would build on and broaden existing elements of drug regulation, including accelerated approval (in US) or conditional marketing authorization (in EU). This session summarizes a number of recent AL proposals and discusses how AL might be translated into practice.

Learning Objectives:
Discuss current proposals in this field and how these relate to different stakeholders' interests
Recognize the opportunities and challenges that need to be addressed before adaptive licensing pathways can be translated into practice.