According to the FDA Guidance Document, Target Product Profile is a useful Strategic Development Process Tool to facilitate communication regarding a particular drug development program [1]. The importance of the TPP in the focus and facilitation of the FDA approval is no doubt quite significant as it contributes to the reduction of the review time [2]. However, even though the facilitation of the FDA review through a TPP is advantageous it still remains underutilized [3]. This under-utilization is perhaps due to the lack of the vision on how one can optimize target product profile and use it as the main driver for the entire product development. Later on, we will outline how one can use TPP to assess the value of development candidate and how that value can be optimized through a holistic look at the TPP.

Target Product Profile contribution to the specification and management of the overall commercial strategy is equally important as the commercial success is typically the final development goal. The lack of commercial success has been seen in numerous examples of bio-pharmaceutical products that have been developed, approved and launched. TPP enables you to start with end in mind and to define, align and manage your product development to the agreed goal with the right messaging, post-launch data and services differentiators. Bain&Company research has indicated that that nearly 50% of launches over the past eight years from 2017, have under-performed analyst expectations, and more than 25% have failed to reach even 50% of external revenue forecasts. In other words, a proper definition and assessment to optimize Target Product Profile enables R&D organizations to better adopt the ‘Commercially Driven’ bio-pharmaceutical product development.