2Translational & Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom; Newcastle NIHR Biomedical Research Centre, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.
5Gilead Sciences, Inc, Foster City, California, USA.
6Novartis, East Hanover, NJ 07936, USA.
7Takeda Development Center Americas, Inc., 95 Hayden Avenue, Lexington, MA 02421, USA.
8Radcliffe Department of Medicine, University of Oxford, Oxford, United Kingdom.
9Institute of Translational Immunology and Research Center for Immune Therapy, Mainz University Medical Center, 55131, Mainz, Germany; Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, 02215, USA.
10Centre for Digestive Diseases, Lausanne, Switzerland.
13Sorbonne University, France; Pitié-Salpêtrière Hospital, France.
14Global Product Development, Internal Medicine and Hospital, Pfizer Inc, Florida, USA.
15Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Centre, Amsterdam, the Netherlands.
16Nordic Bioscience, Denmark.
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.