NAFLD and NASH Biomarker Qualification in the LITMUS consortium - Lessons learned

Daniel Guldager Kring Rasmussen, Quentin M Anstee, Richard Torstenson, Bruno Golding, Scott D Patterson, Clifford Brass, Paresh Thakker, Stephen Harrison, Andrew N Billin, Detlef Schuppan, Jean-François Dufour, Anneli Andersson, Ioan Wigley, Elizabeth Shumbayawonda, Andrea Dennis, Corinna Schoelch, Vlad Ratziu, Carla Yunis, Patrick Bossuyt, Morten Asser Karsdal

Research output: Contribution to journalReview articleAcademicpeer-review


Biomarkers have the potential to accelerate drug development, as early indicators of improved clinical response, to improve patient safety, and for personalized medicine. However, few have been approved through the biomarker qualification pathways of the regulatory agencies. This paper outlines how biomarkers can accelerate drug development, and collects the lessons learned by the EU IMI2-funded LITMUS consortium, which has had several interactions with regulatory agencies in both the US and EU regarding biomarker qualification in patients with non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). Sharing knowledge of such interactions with the scientific community is of paramount importance to increase the chances of qualification of relevant biomarkers that may accelerate drug development, and thereby help patients, across disease indications. A qualified biomarker enables a decision to be made that all understand and support in a common framework.

Original languageEnglish
JournalJournal of hepatology
Publication statusE-pub ahead of print - 13 Dec 2022

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