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Policy and Practice Reviews ARTICLE Provisionally accepted The full-text will be published soon. Notify me

Front. Pharmacol. | doi: 10.3389/fphar.2019.01377

EUFEMED Lyon Conference 2019: The Changing Landscape of Early Medicines Development - Be Prepared

  • 1Niche Science & Technology Ltd, United Kingdom
  • 2Association Francaise de Pharmacologie Translationelle (AFPT; formally Le Club Phase 1), France
  • 3Belgian Association of Phase I Units, Belgium
  • 4Association for Human Pharmacology in the Pharmaceutical Industry, United Kingdom
  • 5Association for Applied Human Pharmacology, Germany

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 modelling 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/

Keywords: early phase clinical drug development, the EUropean Federation for Exploratory MEdicines Development (EUFEMED), Conference report, pharmaceutical, FIH

Received: 10 Sep 2019; Accepted: 29 Oct 2019.

Copyright: © 2019 Hardman, Caplain, Rottey, Douglas, Stringer and Sourgens. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Mx. Tim Hardman, Niche Science & Technology Ltd, Richmond, United Kingdom, tim.hardman@niche.org.uk