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, Vanessa Zann will describe how the application of Quotient Sciences’ Translational Pharmaceutics to re-engineer this process has created a Rapid Formulation Development and Clinical Testing approach, using clinical data to improve decision-making and halve development timelines using case studies from over 300 delivered programs.
