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Lookup NU author(s): Professor Quentin AnsteeORCiD
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (CC BY-NC-ND).
© 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.
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
