Drug-induced liver injury (DILI) is a significant factor in drug attrition rates. Safety concerns are responsible for approximately 30 % of drug development failures, with hepatotoxicity specifically contributing to 18 % of these cases.
While traditional preclinical models are effective in identifying intrinsic, dose-dependent DILI, they often fall short in predicting or uncovering the mechanisms behind complex human DILI. This limitation means that indirect or idiosyncratic DILI risks can go unnoticed during preclinical and clinical stages, potentially leading to financial and reputational challenges for drug developers.
This webinar introduces the PhysioMimix® DILI assay, a tool designed to enhance risk assessment in drug development workflows. Using a human liver microphysiological system (MPS), also known as organ-on-a-chip (OOC), CN Bio explores data-rich investigative toxicology studies with drugs that are known to cause human toxicity.
The system allows for a deeper understanding of the mechanisms by which drugs can cause DILI, including oxidative stress, mitochondrial dysfunction, steatosis, disruptions in bile acid synthesis or transport, and inflammatory responses.
The webinar will also highlight how these insights enable drug developers to make more informed decisions, improve drug design, and reduce risks during the clinical progression of future candidates.
Learning objectives
- Understand how the PhysioMimix human Liver MPS mimics organ functions.
- Learn how to use the PhysioMimix DILI assay to forecast human risk.
- Identify DILI pathways using the assay.
- Understand MPS's role in drug research and development.
About the speaker
Dr. Ovidiu Novac is a Senior Scientist at CN Bio and a leading expert in organ-on-a-chip (OOC) technology.
Dr. Novac has extensive experience as a lead biological scientist, contributing to numerous assay development projects and specializing in assessing drug-induced liver injury in vitro. He also has a strong background in the development and performance evaluation of pharmaceutical and dermatological formulations, focusing on their effects on human skin tissue ex vivo (both topical and transdermal applications). His expertise extends to strategic planning for further evaluations in these areas.
Dr. Novac has played a key role in producing high-quality data for marketing and regulatory submissions in the pharmaceutical industry. He holds a BSc in Biomaterials and Prosthetic Technologies and a Ph.D. in Chemistry and has been involved in research on controlled drug delivery systems since 2006.