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

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

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 journal › Review article › Academic › peer-review

Abstract

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 language	English
Journal	Journal of hepatology
DOIs	https://doi.org/10.1016/j.jhep.2022.11.028
Publication status	E-pub ahead of print - 13 Dec 2022

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

Cite this

Rasmussen, D. G. K., Anstee, Q. M., Torstenson, R., Golding, B., Patterson, S. D., Brass, C., Thakker, P., Harrison, S., Billin, A. N., Schuppan, D., Dufour, J-F., Andersson, A., Wigley, I., Shumbayawonda, E., Dennis, A., Schoelch, C., Ratziu, V., Yunis, C., Bossuyt, P., & Karsdal, M. A. (2022). NAFLD and NASH Biomarker Qualification in the LITMUS consortium - Lessons learned. Journal of hepatology. https://doi.org/10.1016/j.jhep.2022.11.028

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title = "NAFLD and NASH Biomarker Qualification in the LITMUS consortium - Lessons learned",

abstract = "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.",

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

year = "2022",

month = dec,

day = "13",

doi = "https://doi.org/10.1016/j.jhep.2022.11.028",

language = "English",

journal = "Journal of Hepatology",

issn = "0168-8278",

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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 2022, 'NAFLD and NASH Biomarker Qualification in the LITMUS consortium - Lessons learned', Journal of hepatology. https://doi.org/10.1016/j.jhep.2022.11.028

TY - JOUR

T1 - NAFLD and NASH Biomarker Qualification in the LITMUS consortium - Lessons learned

AU - Rasmussen, Daniel Guldager Kring

AU - Anstee, Quentin M

AU - Torstenson, Richard

AU - Golding, Bruno

AU - Patterson, Scott D

AU - Brass, Clifford

AU - Thakker, Paresh

AU - Harrison, Stephen

AU - Billin, Andrew N

AU - Schuppan, Detlef

AU - Dufour, Jean-François

AU - Andersson, Anneli

AU - Wigley, Ioan

AU - Shumbayawonda, Elizabeth

AU - Dennis, Andrea

AU - Schoelch, Corinna

AU - Ratziu, Vlad

AU - Yunis, Carla

AU - Bossuyt, Patrick

AU - Karsdal, Morten Asser

PY - 2022/12/13

Y1 - 2022/12/13

N2 - 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.

AB - 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.

U2 - https://doi.org/10.1016/j.jhep.2022.11.028

DO - https://doi.org/10.1016/j.jhep.2022.11.028

M3 - Review article

C2 - 36526000

JO - Journal of Hepatology

JF - Journal of Hepatology

SN - 0168-8278

ER -