Aligning Clinical Development with Target Product Profile and Market Requirements
Challenge
Through a series of in-depth meetings and scientific assessments, we explored various clinical development paths for the compound across multiple indications. Our team worked closely with the client to assess the scientific potential of the product’s novel mode of action and evaluated options that would align the clinical strategy with the desired TPP.
Solution
Impact
Ultimately, we determined that the product lacked a viable market fit and recommended its discontinuation during Phase 1, saving the client hundreds of millions of euros that would have been spent on further development. A market review conducted several years later confirmed that there was no viable commercial opportunity for the product, validating the decision to halt its progress early.
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.