Succeeding in Europe
First and foremost, the company has to have a launch product that they can afford to launch themselves, i.e., not overly resource intensive – typically a rare disease or specialist product, with a strong clinical value proposition vs an alternative in the clinical practice.
So, the first thing the aspiring new entrant has to do is an opportunity assessment with a focus on clinical positioning and market access. It is important to do this very early – at least by six months before the start of Phase 3 trial, if not at the start of Phase 2b, of the first programme.
– Understand how the product might be used and differentiated
– Set the target label and study pricing / reimbursement
– Clarify data requirement
– Consider tax and IP location strategy
– Devise a high-level road map for building the European franchise
There are independent consultants and specialist firms that can support this part of the journey. Hire/transfer a reliable executive and run a series of projects. Make sure that consultants are local and have up-to-date functional domain expertise in the European context.
Then, once the end of Phase 3 is near, the company can start investing in in-house launch capabilities: supply chain, registration, market access, medical, commercial and supporting functions.
The key here is not to build the overhead too early as there are always delays and set backs in clinical trials. In addition, the business environment for smaller biotech is unpredictable and corporate direction can change quickly. Companies are best advised to refrain from hiring too many people until it is ready commit to the build out and launch in Europe.
The team on the ground have to manage a vertical take-off and an extremely busy period during the twelve months up to the launch. Finding experienced senior leaders and delegating authorities would be the key to get the work done well and quickly.
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