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Case Studies

Case Study: Strategic Evidence Planning

Case Study: Strategic Evidence Planning


A new and growing biopharmaceutical company had recently launched a novel drug targeting specific mutations found in mostly haemotological cancers, but also for solid tumours.  Although clinical interest in the new agent had developed organically, the number of company and investigator sponsored studies had grown large and a clear strategy was not in place to support further investment in clinical studies.  A plan was required to help shape future investment in clinical studies and support expanded label usage for the new agent.

Our Actions:

Circuit Medical worked with the client to firstly understand the status of studies undertaken, committed to and in the pipeline.  Circuit Medical then worked with the client to develop a prioritization framework taking into consideration the degree of unmet need for populations of interest as well as the supporting scientific rationale supporting usage in such populations (and therefore indicating likelihood of success).  A workshop then followed to prioritise the different indications/populations of interest using a mixture of epidemiological data, scientific evidence and commercial analysis.  Working through a couple of iterations and consulting with experts, a prioritised list on indications/populations of interest was produced and agreed with the team responsible for evidence generation.  Next, a list of prioritised evidence requirements was drafted within indications/populations, using set criteria to further support future investment cases.

The Outcomes:

The client was satisfied that a prioritised indication/population of interest list was available to guide future investment.  The list was used to assess new investigator sponsored study proposals and guide investment decisions to those areas where the scientific rationale was greatest to support exploration of the new asset in areas of the highest unmet need.  The client used this work in a different workstream that concentrated on future areas of interest for label expansion.  Alignment around interests was achieved and the client was satisfied with having a sound decision making framework to help collaborations with investigators.

Circuit Medical has worked on numerous evidence generation strategies and plans across multiple therapeutic areas and with many different therapeutic modalities, get in touch to find out more about how we can support your evidence generation priorities.

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