By Simon Ellison
Conducting the advanced therapy supply chain orchestra is more than waving a stick at people – it is an “end to end”, complicated, inter-related system that requires controlled, consistent management (1). For the purpose of this article, advanced therapies are seen as cell and gene based therapies. These therapies are showing fantastic clinical results and are now on the brink of becoming a commercial reality. Initially, advanced therapies are likely to be for small, orphan indications, but over the coming years I expect them to expand to address larger health challenges, such as stroke or diabetes. The value of advanced therapies is that they can potentially offer long-term solutions, and even cures, to unmet medical needs.
There are many challenges involved in developing an advanced therapy product – and rightly so R&D is the main focus for any company in the field. While focusing on building a strong melody, however, it’s important not to overlook how it will be delivered to the audience. Otherwise you may find that your delivery is closer to a garage band than a full Philharmonic. In other words, it is important to consider a coordinated supply chain management plan. In my view, this should be done as early as possible within the therapy’s development.