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Go/No-Go: Gaining mechanistic insights of toxicity using a human DILI microphysiological system to inform decision making

12th November, 3pm UK time 

Drug-induced liver injury (DILI) events cause a large proportion of drug attrition – with 30% of all drug development failures due to safety concerns and 18% due to hepatotoxicity specifically. More importantly, many DILI events occur post-marketing due to indirect or idiosyncratic events that are not identified in preclinical and clinical trials – leading to financial and reputation loss for drug developers. Current models used in drug development and preclinical safety trials, although sufficient at capturing most intrinsic toxic events, have significant limitations and are not effective at predicting or understanding more complex DILI mechanisms in humans. In this webinar, we will discuss how the PhysioMimix® DILI assay offers a solution to these challenges. Through utilization of the microphysiological system (MPS), otherwise known as Organ-on-a-chip (OOC), we show that data-rich investigative toxicology studies can be made for identified toxic compounds. This allows drug developers to identify mechanisms of toxicity, thus empowering informed decisions to modify drug design and de-risk clinical progression of future drug candidates.

  • Determine how human liver MPS is applied to predicting DILI risk.
  • Learn how the human liver MPS can identify different mechanisms of toxicity.
  • Identify where MPS/OOC best fit within the drug discovery and development pipeline and how they are most suitably applied.
  • Learn about the PhysioMimix human liver MPS model and how it recapitulate the functionality of the liver.

 

Dr Ovidiu Novac
Senior Scientist, CN Bio

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Dr Ovidiu Novac is a Senior Scientist at CN Bio and a knowledgeable organ-on-a-chip (OOC) expert. Ovi performed on several assay development projects as lead biological scientist, is a knowledgeable organ-on-a-chip (OOC) expert, and has experience in assessing drug induced liver injury in vitro. Ovi has a background in the developmental stage of pharmaceutical and dermatological formulations and their performance assessment on human skin tissue ex vivo (topical and transdermal), and for strategic planning for further evaluation. During time spent in the pharma industry he contributed to delivering high quality results used for marketing purposes and in regulatory submissions. Ovi holds a BSc in biomaterials and prosthetic technologies and a PhD in chemistry and has been involved in research on controlled drug delivery systems since 2006.

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