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Vermilion Life Sciences Ltd
A medium sized European company had experienced a recent Phase III failure in its lead asset in a competitive therapeutic area. Their follow on asset showed promise but there was reticence to invest aggressively because of cost concerns, and the fact that this project was projected to be approved relatively shortly before its patent expiry. In addition its late development would make differentiation and data generation against competitor projects challenging.
Upon review of the data available we rapidly addressed the challenges of time to approval, and the ability to generate comparator data. We identified the critical success factors and were able to design a proposal that prioritised these for early evaluation, and determination of probability of success to reduce risk. We incorporated a sequential plan to generate data against newly approved comparators that were more advanced in development, as these seemed likely to be approved before our asset. Our proposal projected saving two years to approval, and included generation of comparator data for pricing and reimbursement that was not possible with a traditional plan. It also projected that the asset could overtake competitors in development.
In our data review we also identified a potential responder population who were recommended for more intensive evaluation and additional targeting for even earlier approval.
Our plans demonstrated the ability to save at least two years in development, with substantial cost savings and competitive advantage by leapfrogging competitors.
Please contact us for a discussion of how we can streamline your development plans to maximise value, minimise risk and cut costs and time to filing and uptake.