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Projects
A mid-sized pharmaceutical company was nearing the completion of clinical development for a product targeting an orphan indication. While the product showed promise in this niche market, its mechanism of action also presented a significant opportunity in a broader indication with a high unmet medical need. However, launching the product in this larger market would likely necessitate a substantial price reduction, potentially undermining the profitability of the orphan indication.
A large pharmaceutical company asked us to evaluate the business potential of a new cardiovascular product. Upon review, we discovered a critical misalignment between the clinical development plan and the Target Product Profile (TPP). The TPP aimed to demonstrate superiority over a competitor, while the clinical development plan was designed to establish non-inferiority, risking the commercial viability of the product.
A client’s clinical development plan involved a staggered regulatory approval—initially with surrogate data followed by outcome data 18 months later. While this approach accelerated the time to market, there was concern that launching based on surrogate data might establish a lower price point that could not be adjusted upward even after the release of compelling outcome data.
A large pharmaceutical company sought to reposition a drug that had already been commercialized for one indication but was also undergoing clinical trials in co-morbid conditions and additional independent indications. The challenge was to refine the brand positioning to maximize the potential of these label extensions and reach a broader prescriber audience.
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