Leveraging real-time clinical data to deliver certainty in formulation development

Drug product optimization is a critical development step that is common for most drugs that are progressing through today’s development pipelines to respond to suboptimal exposure profiles, to transition from an early development formulation to one suitable for chronic administration in patients, or as part of a life-cycle management strategy.

Traditional drug product optimization processes take 12-18 months to complete and place significant emphasis on the predictive power of laboratory and preclinical assessments. This approach is a non-optimal working model necessitated by the multiple disciplines required to develop, make and test new formulations in humans.

In this presentation at the Basel Innovation Centre, Dr Andrew Parker will describe how to re-engineer and streamline the drug product optimization process, using clinical data to improve decision-making and halve development timelines.

Learning Objectives:

• Develop an understanding of Translational Pharmaceutics when applied to drug product optimization
• Hear case studies on reformulation programs