Challenges & Practical Considerations In Predicting Idiosyncratic Drug-Induced Liver Injury

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About the Article Collection

Drug-induced liver injury (DILI) causes significant problems to healthcare providers, pharmaceutical companies, regulatory agencies, and patients.

Drugs account for 20-40% of all hepatic failures and DILI is a common cause of failure in clinical trials and reasoning behind the withdrawal of drugs from market [1]. Idiosyncratic DILI occurs at therapeutic doses of drugs in comparison to intrinsic DILI which is dependent on dose.

Approximately 75% of idiosyncratic drug reactions result in liver transplantation or death [1]. Predicting idiosyncratic DILI before it occurs is, therefore, a necessary and critical step to prevent harm to patients and accelerate progress toward safer and more effective medication.

With contributions from world-class key opinion leaders across academia and industry, this article collection will delve into the latest research, innovative methodologies, and advances in predicting DILI, while addressing real-world challenges.

The collection will contribute to advancing our understanding of idiosyncratic DILI prediction, and hopefully, a future where DILI is prevented and managed with precision and foresight.

We are delighted to work alongside the guest advisors; Adrian Ray and Jack Utrecht.

The collection welcomes authors to submit relevant editorials, reviews, perspectives, pharmacokinetic evaluations and original research.

Topics of interest include, but are not limited to:

  • Current techniques for screening DILI; spheroid models, organ-on-chip models

  • Biomarkers in DILI

  • AI and machine learning algorithms

  • Pharmacogenomics

  • Clinical application of predictive techniques in DILI

The benefit of publishing as part of an article collection is that they often become a key resource, driving a research community forward. This has a synergistic effect on every article in the issue.

If you are interested in contributing or would like to learn more, please reach out to the Commissioning Editor, Amelia Dennis, who will be happy to assist.

[1] https://emedicine.medscape.com/article/169814-overview?0=0=reg=1&1=reg=1

Submission Information

Submission Deadlines:

Standard  – December 5th, 2024

7-9 Weeks – January 23rd, 2025

3-5 Weeks – February 20th, 2025

About the Guest Advisors:

Adrian Ray

Dr. Ray has over two decades experience in biotech working at Gilead, Nimbus, Morphic and, most recently, serving as Chief Scientific Officer at Third Harmonic Bio. He has provided leadership for small molecule drug discovery, nonclinical development and translation across therapeutic areas contributing to numerous IND and successful worldwide registrational filings. Dr. Ray has authored >100 peer-reviewed articles, reviews, book chapters and letters to the editor in prestigious journals including manuscripts published in Science and Nature. He is an inventor on >30 granted US patents including those supporting successful drugs Harvoni and Veklury.

Dr. Ray received his undergraduate degree in Molecular, Cellular and Developmental Biology from the University of California at Santa Cruz graduating with Highest Honors. He completed his graduate studies in the Pharmacology Department at Yale University. Dr Ray was the recipient of the William H. Prusoff Young Investigator Lecture Award and the James R. Gillette Drug Metabolism and Disposition Best Paper Award.

Jack Uetrecht

Dr. Uetrecht is professor of pharmacy and medicine at the University of Toronto and past Canada Research Chair of Adverse Drug Reactions. He has over 40 years of experience and over 200 publications in the field of idiosyncratic drug reactions.  His contributions include identification of several reactive metabolites of drugs associated with idiosyncratic drug reactions.  This includes reactive metabolites formed by myeloperoxidase and sulfotransferase, and demonstration of how these pathways are involved in idiosyncratic drug reactions.  He has developed an animal model of nevirapine-induced skin rash, and he used PD-1 KO mice to develop models of immune-mediated liver injury.  He also developed a modified PD-1 rat model.  He has also shown the involvement of inflammasome activation in the immune response to drugs.  He has shown that simple inhibition of the mitochondrial electron transport chain is not involved in the mechanism of drug-induced liver injury.  He has found possible biomarkers such as GDF-15 to predict which drug candidates will cause idiosyncratic drug reactions.  His suggestion that starting with a very low dose of cenobamate followed by dose escalation would prevent the development of DRESS made approval of this drug possible, and a similar strategy would likely be effective in preventing idiosyncratic reactions to other drugs.

Dr. Uetrecht earned a Ph.D. in organic chemistry from Cornell University, an M.D. degree from Ohio State University, an internal medicine residency at the University of Kansas Health Science Center and a clinical pharmacology fellowship at Vanderbilt University.  He is a fellow of the American College of Internal Medicine, a fellow of the Canadian Academy of Health Sciences, and was awarded the Vos Lifetime Career Achievement Award in Immunotoxicology by the Society of Toxicology. He was ranked number 1 by ScholarGPT in the field of adverse drug reactions and number 10 in the field of drug metabolism and number 10 in the field of liver injury.

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