Lessons for Product Profile Creation

Implications: The user-friendly and health care provider comfort aspects of an product with otherwise proven safety and efficacy must be considered when deciding how, when, and in what manner to develop f drug product. Despite the desirability of a non-injectibel insulin, the inhaled route of administration and acceptability of the formulation must be carefully examined in the real-world, and not just clinical trial, environments. This firm, despite its long history and expertise, missed the boat.

Analysis: Careful market analysis, as well as a thorough review of clinical tiral data, outcomes, and acceptability of the dosage form, would have likely provided a go/no-go decision earlier for the product. It does not good to have an expensive approval that fails in the marketplace. Writing off development costs without a spectacular failure in clinical use acceptability would be an important consideration for those to follow.