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NAFLD and NASH biomarker qualification in the LITMUS consortium – Lessons learned

Lookup NU author(s): Professor Quentin AnsteeORCiD

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Abstract

© 2022 The Author(s)Biomarkers have the potential to accelerate drug development, as early indicators of improved clinical response, to improve patient safety, and for personalised 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 reviews 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 and non-alcoholic steatohepatitis. 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.

Publication metadata

Author(s): Rasmussen DGK, Anstee QM, Torstenson R, Golding B, Patterson SD, Brass C, Thakker P, Harrison S, Billin AN, Schuppan D, Dufour J-F, Andersson A, Wigley I, Shumbayawonda E, Dennis A, Schoelch C, Ratziu V, Yunis C, Bossuyt P, Karsdal MA

Publication type: Review

Publication status: Published

Journal: Journal of Hepatology

Year: 2023

Volume: 78

Pages: 852-865

Print publication date: 30/04/2023

Online publication date: 13/12/2022

Acceptance date: 25/11/2022

ISSN (print): 0168-8278

ISSN (electronic): 1600-0641

Publisher: Elsevier B.V.

URL: https://doi.org/10.1016/j.jhep.2022.11.028

DOI: 10.1016/j.jhep.2022.11.028

PubMed id: 36526000

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