Phase IIIb/IV clinical development strategy


Our client had positive Phase III data, resulting in a US and an EU marketing application. This was within a relatively small – but clinically critical – area of breast cancer. The client wanted our support in developing and executing a Phase IIIb/IV clinical development strategy and plan for the product to best meet the needs of the cancer community and the commercial body.


The product needed to be differentiated to stand out from the array of breast cancer treatments available. The client needed to define their positioning and to identify the data and studies that would best support this.


We delivered a staged approach, beginning with an evaluation of the competitor environment and the strength of the existing labels and Summaries of Product Characteristics of relevant competitors. This was supplemented with an assessment of public domain information regarding ongoing and future studies and the populations and endpoints under investigation. We created a ‘development heat map’, allowing our client to fully understand where competitor activity was highest and to assess the ‘white space areas’ where the potential of the client’s product overlapped with areas currently underserved by competitor and academic activity. Once the client had identified their areas of focus, we developed and delivered an external consultancy initiative to (i) validate the client’s thinking; (ii) establish skeleton protocols and associated action plans for the main areas of interest; and (iii) identify areas of academic interest that would form part of an assessment protocol for the submission of sponsor-supported, investigator-led protocols for new clinical studies.