Preclinical Development – Chemical
2019 PharmSci 360
The focus of this session will be on presenting an overview of the emerging tools for improving drug candidate selection and drug product optimization. This Prologue presentation will provide an overview of the challenges encountered in in early stage drug development , specifically between lead optimization and drug formulation design. The increasing importance of modelling tools and bio-predictive approaches to guide drug formulation selection in pre-clinical settings will be discussed. The presentation will describe briefly emerging trends for predicting developability and applying risk-based/model-informed decision-making in lead candidate selection. This encompasses improved understanding and characterizing of biological systems, advances in screening tools, bio-relevant characterization incorporating early stage “fit for purpose” models for formulation optimization. This introductory presentation will set the scene in relation to emerging 'best practice' industry drug development guidelines and application of computational tools in model informed drug development. The presentation will then briefly introduce the more specific topics that will be presented by the various symposium speakers in the morning session.