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The Importance of Early Positioning in Drug Development

The Importance of Early Positioning in Drug Development

For some, product positioning is reactionary and established largely after data from a pivotal trial is ready. After all, how can a product’s positioning be established without knowing how the data stacks up to competitors? While it is true a product’s positioning will be constrained by the data submitted to the FDA, early positioning work can reveal opportunities for a novel treatment to differentiate itself from standard of care (SOC) through creative pivotal trial design. What we hope to convey here is that an asset does not need to be all things for all patients to be a success.

Improving upon the SOC’s efficacy is not the only way to become a market leader. Instead, as examples, designing a pivotal trial with a distinct dosing schedule, new safety endpoints, or a differentiated trial population are all ways to show additional value and carve out a meaningful share of the market. There is ample research to date showing that even a relative 10% improvement over the SOC’s primary endpoint may not be enough to overcome incumbency advantages. Fortunately, conducting positioning research early in clinical development can show many ways to move away from this head-to-head comparison and allow for tailoring of a product to segments not fully served by SOC.

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