Document is current

Article History

Accepted: 7 October 2020

First Online: 3 November 2020

Declarations

:

: Not applicable. All work on this paper was done voluntarily and no compensation was paid to any of the authors.

: Drs. Chalasani, Avigan, Dimick-Santos, and Rockey have no conflicts of interest that are directly relevant to the content of this paper. Dr. Chalasani has ongoing consulting activities (or had in the preceding 12 months) with NuSirt, AbbVie, Eli Lilly, Afimmune (DS Biopharma), Allergan (Tobira), Madrigal, Shire, Axovant, Coherus, Pronova (BASF), Siemens, and Genentech. These consulting activities are generally in the areas of NAFLD and drug hepatotoxicity. Dr. Chalasani receives research grant support to his institution from Intercept, Lilly, Galectin Therapeutics, and Cumberland. Over the last decade, Dr. Chalasani has served as a paid consultant to more than 30 pharmaceutical companies, and his outside activities have regularly been disclosed to his institutional authorities. Drs. Treem, Lonjon-Domanec, Seekins, Dash, Regev, Marcinak, and Patwardhan are full-time employees of Takeda,ssen Pharmaceutica NV, Bristol Myers Squibb, Genentech, Eli Lilly, Pfizer, and AbbVie, respectively. Dr. Palmer was a full-time employee of Takeda (formerly Shire) during the drafting of this paper and is now at Liver Consulting LLC. Drs. Palmer, Lewis, and Freston serve as consultants to several pharmaceutical companies for activities related to NAFLD and DILI but have not derived any financial or other compensation from activities related to developing this best practices document. Dr. Rockey receives ongoing research grant support to his institution from Galectin Therapeutics, Genfit, Gilead Sciences, Intercept Pharmaceuticals, Mallinckrodt Pharmaceuticals, Salix Pharmaceuticals, and Sequana Pharmaceuticals. Dr. Maller was a full-time employee of Pfizer during the drafting of this paper and is now at MEMS Biopharma Consulting, LLC. Dr. Di Bisceglie serves on adjudication committees for AbbVie and Daichi Sankyo, on a data safety monitoring committee for Eiger, and as a consultant and chief medical officer to HighTide Therapeutics, which is developing a therapy for fatty liver disease. He has not derived any financial or other compensation from activities related to developing this best practices document. Dr. Andrade serves as a consultant to several pharmaceutical companies for activities related to NAFLD and DILI but has not derived any financial or other compensation from activities related to developing this best practices document.

: Not applicable.

: Not applicable.

: Not applicable.

: All data reviewed and analyzed in this paper are already in the public domain in previous publications, abstracts, conference presentations, and on ClinicalTrials.gov.

: Not applicable.

: Ajit Dash, M.D., Ph.D., MBBS, Genentech, Inc.; Isabelle Lonjon-Domanec, M.D,ssen Pharmaceutica NV; Eric Maller, M.D., Pfizer; John F. Marcinak, M.D., AbbVie; Melissa Palmer, M.D., Liver Consulting LLC (formerly with Takeda); Niti Patel, Ph.D., DABT, Takeda; Meenal Patwardhan, M.D., MHSA, AbbVie Inc.; Ritu Raheja, MPH/MBA, AbbVie Inc.; Arie Regev, M.D., Eli Lilly and Company; Daniel Seekins, M.D., Bristol Myers Squibb; William R. Treem, M.D., Takeda; Hui-Talia Zhang, M.D., Ph.D, Bayer HealthCare Pharmaceuticals.

: All industry, academic, and regulatory-based authors contributed to the paper’s conception, design, and development through a series of in-person and virtual working sessions. Material preparation, data collection, and analysis were performed primarily by Will Treem, Melissa Palmer, Isabelle Lonjon-Domanec, Daniel Seekins, Jon Marcinak, and Ajit Dash. The first draft of the manuscript was written by the same six authors, and all authors subsequently commented on and edited all versions of the manuscript. All authors participated in the development and agreed upon the consensus recommendations in the paper and read and approved the final manuscript.