Developing PreDICT – a fully integrated data platform for preclinical in vivo data: learning from experience

摘要

Highlights ? We describe a project that implemented a fully integrated solution for in vivo data. ? Discuss cultural and technical learnings as well as blockers to success. ? PreDICT provides a novel platform for animal level in vivo PK, PD and efficacy data. ? It enables best practice in the integration, management and retention of data. ? The challenges in maintaining such a platform are highlighted. In vivo models have been crucial for developing our understanding of key processes associated with human disease and developing novel therapeutics. These in vivo studies are becoming increasingly complex, requiring long-term efficacy data and additional supportive datasets such as pharmacokinetic profiles and analysis of multiple biomarkers of pharmacodynamic response and efficacy. Moreover, a new agent will be investigated in many different models and often in combination with other drugs. Despite advances across the industry integrating and analysing complex datasets, management of in vivo data remains an ongoing challenge across the industry. Here, we describe a project that has successfully delivered a working solution to integrate pharmacokinetic, biomarker and efficacy data, independent of therapy area.