White Paper

Cell and gene therapies (CGTs) offer the potential for a step change in treatment management principles and outcomes expectations across an ever increasing spectrum of diseases. However, bringing CGTs to market is still at a nascent stage embodying the well known phrase of ‘flying the plane while building it’. That said, R&D efforts are churning at an unprecedented rate, with the time window ever shortening from bench to bedside.

This paper seeks to provide practical strategic advice to teams charged with the launch commercialization of CGT assets. The focus is at the acute end of launch planning and preparation, where organizations are looking to evaluate ‘what to gear up; when to gear up; and who to gear up with’, to establish market awareness, anticipation and readiness.

It is clear that CGTs bring a unique set of considerations that are different to mainstream launches. Following an overview of the different nature of these therapies that fall under the umbrella term of ‘advanced therapies’, 10 overarching strategic recommendations outline a road map for launch commercialization. It is impossible to cover all the considerations and permutations that may need to be undertaken. Instead, our aim is to share core areas of focus and strategic evaluation that provide a checklist for effective internal evaluation and external stakeholder engagement.

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