Regulatory strategies for value maximisation of early clinical stage assets

Prepare for partnering – Optimizing value in early development

There are many important reasons why a company would choose not to develop and commercialise a product on their own. The cost of development increases exponentially, making the final stages impossible to finance for many companies. Building a commercial organisation covering vast territories can be an equally daunting task.

Companies we work with have a clear definition of what it is they want to do and often their strategy is limited to discovering and developing proofs of concepts of products in a certain region; the rest is simply not part of their focus. Whatever the reason, the goal for many companies we work with is often to develop the product to a stage where partnering or out-licensing becomes feasible.

This white paper written by Niamh Kinsella, Biologics Expert, Paul Chamberlain, Biopharmaceuticals Expert, Josi Holz, Clinical Strategy Expert and Eva Lilienberg, Service area lead Global Development, focus on how you can strengthen your partnering negotiation position, reduce the time to the clinic and to help you determine value-adding regulatory milestones by applying integrated regulatory strategies, ultimately optimising the value of your asset at the point of exit.






Niamh Kinsella
Paul Chamberlain
Josefin-Beate Holz
Eva Lilienberg