Target Product Profile-Based Product Development: The Importance of Using a Holistic Approach for Your Program

A key element of a drug product’s long-term success is its Target Product Profile (TPP), specifically in building a framework for understanding patient needs, market differentiators, and potential hurdles in the development of a new product. Traditional dosage form design and development is frequently driven by cost and timeline constraints; however, additional profiling is required to make the program commercially successful. For example, a holistic evaluation of factors including pharmacokinetics, stability, patient compliance, disease state, and IP or market protection can significantly impact the product’s ultimate market success.

In this session, learn about the importance of a holistic approach to drug development and using the TPP to identify and address key considerations that will ensure a robust drug design strategy. Case study scenarios will illustrate how a holistic assessment of an API’s biopharmaceutic properties, manufacturability, market requirements, and target patient population has helped innovators identify the most suitable development path to ensure their product’s success.

Lisa Caralli, Senior Director, Scientific Advisory, Catalent