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Clinical Development Planning Experience
A large company was developing a novel asset in a therapeutic area where it had a dominant share. With concerns of patent expiry of its existing assets looming, speeding time to filing and approval of the new asset was a key objective. In evaluating development plans, a traditional proposal predicted approval at least a year after patent expiry of the existing brand, thus risking continuity of the company's therapeutic presence, but also its potential revenue to re invest into R&D.
A review within the project team identified essential criteria for project success and patient benefit, and a risk register evaluated whether an overly conservative regulatory plan had been proposed. The team subsequently developed an alternative, more aggressive plan, with a higher risk approach to regulatory filing, with a clear set of arguments on risk mitigation. This was taken to FDA and EMA for, 'End of Phase II' and Scientific Advice meetings respectively, with the plan being endorsed as acceptable should the studies be sufficiently positive. These plans were simultaneously reviewed by corporate governance who recognised the risk, but also the significant upside in development time. The downside was a reversion to the original plan so there was limited incremental risk exposure.
Once the plans and revised budget were endorsed, the team worked with and motivated its cross functional membership based on their ability to accelerate the plan. The patient benefit became a significant factor to drive a culture and behaviours that led to real team cohesion. This allowed team members to work within their functions to prioritise resources and work scheduling, to ensure that the more aggressive plan kept to time.
At the end of the programme, the team delivered its studies on schedule, with positive data. This led to filing and approval of the medicine prior to loss of exclusivity of the existing brand. An 'at risk' approach delivered significant upside at some cost, but substantial benefit. Articulating these plans and the acceleration to delivery as a result of the additional investment, and a more aggressive approach, made a substantial difference to bringing a medicine to patients much earlier.
Please contact us for a discussion of how our Development Planning experience can help design data generation plans for medicines to become available earlier and with greater certainty of uptake.