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Designed to Win

Posted by on July 11th, 2016.

Blue Matter worked with a global biotechnology company to design the target product profile for a new asthma product in order to improve the probability of commercial success.

Drug development is staggeringly costly and approximately 95% of experimental medicines that are studied in humans fail to clear the regulatory hurdle for final approval. In addition to this, not all products that pass regulatory muster actually perform well in the marketplace. Although there may be a number of reasons for these failures after approval, one of the most important and fundamental reasons for failure of a product is a poorly designed clinical development plan that fails to adequately differentiate the product from competition or address the true needs of key customers. Blue Matter’s approach to designing the target product profile for a new product in development helps combine the commercial perspective and requirements with the clinical and regulatory perspective to ensure that a new product not only clears the technical and regulatory hurdles but also stands the best chance to succeed in the marketplace.

In this particular example, the Blue Matter team worked collaboratively with the clinical and commercial stakeholders to assess and refine the target product profile of a product with an indication in asthma. The team conducted research to determine the product’s revenue opportunity in context of competitors, unmet need, and customer’s likelihood of adoption. The project team discovered that a proposed efficacy endpoint was not relevant for many global markets. As a result, a revised product profile with a clinically more meaningful efficacy endpoint was recommended and the product was successfully approved and launched.