Abstract

The second biennial conference of the European Federation for Exploratory Medicines Development (EUFEMED) was the result of a continued effort of EUFEMED to gather all stakeholders of exploratory clinical drug development to evaluate and discuss recent developments in the field. The conference focused on how the landscape around early clinical development is changing and how clinical pharmacologists might prepare for these changes. A preconference workshop gave consideration to the impact that modeling and simulation, including physiology-based pharmacokinetic strategies, is having on the practice of clinical development. A second workshop looked at the challenges introduced by biological agents. The keynote address explored the potential role of virtual trials in early medicines development with emphasis on how models can help to understand and inform the drug development process. Presentations that followed covered a broad range of subjects including the potential impact of digital support on study performance in early phase development, extending from recruitment to remote data collection, lay person summaries, data transparency, and ethical considerations for trials in healthy subjects. The second day of the conference focused on future regulatory challenges in the field of early clinical development (including Brexit) and how to prepare for changes in the landscape. Subjects covered included new approaches and designs in oncology, the introduction of more complex study designs and digital biomarkers. Presentations given by invited speakers are published at https://www.eufemed.eu/download-presentations-of-the-lyon-conference-2019/.

Highlights

  • The European Federation for Exploratory Medicines Development (EUFEMED, www.eufemed.eu) is a not for profit federation that aims to improve and strengthen the early phase clinical drug development process in Europe

  • A growing number of regulatory submissions include physiologically based pharmacokinetic (PBPK) models that require the use of specialized software platforms

  • PBPK modeling is presently mentioned in several guidelines issued by the European Medicines Agency (EMA), there is limited understanding on what to include in a PBPK modeling report including, in particular, details of the predictive performance of the drug model (European Medicines Agency Science Medicines Health, 2018a)

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Summary

Introduction

The European Federation for Exploratory Medicines Development (EUFEMED, www.eufemed.eu) is a not for profit federation that aims to improve and strengthen the early phase clinical drug development process in Europe. The presentation concluded that model-informed approaches can provide a methodological framework for developing drugs with the optimal dose and delivery characteristics to provide clinical benefits.

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