Aligning regulatory, value demonstration and market access strategy to drive uptake of advanced therapies: what do executives need to know?
23 Jan 2019
The vanguard of transformative and potentially curative regenerative and advanced therapies has launched, with over 25 therapies anticipated to emerge in the next 2-3 years and a robust pipeline of 950 therapies. These therapies, while promising superior magnitude and duration of effect, must also address challenges of the complex regulatory landscape, single-administration value capture, pricing and affordability concerns. Understanding optimal routes through which to engage and approach regulatory and HTA (health technology assessment) interactions is critical to successful product development. This session will highlight best practices and lessons in aligning regulatory, value demonstration and market access efforts to optimize commercial acceptance and uptake, with case examples from North America and Europe.