Project Manager US Food and Drug Administration Silver Springs , Maryland
Presentation Description: Drug-induced liver injury (DILI) is of significant concern to drug development and review because of the limited success with existing preclinical models. For developing alternative methods, a systematic and concerted research effort is required to address the deficiencies in current models, and to present a defined approach towards the development of new or adapted model systems for DILI predictions along with an extensive drug list is essential with known DILI severity and toxicity. This session will not only cover the current understanding from various consortium efforts initiated to address this issue lead by FDA as well as Industry but also provide an opportunity to the audience if they wish to participate and contribute to the efforts. Attendees with developing in-depth understanding and optimal usage of currently existing models along with the de-risking strategies for DILI by understanding underlying DILI mechanism.
This session aims to provide consolidated in-depth understanding and roadmap for de-risking the compounds which could be potentially cause the liver injury later in the development and leads to attrition
This session will also share vast resources, tools and strategies available from developer or regulator stand point ways to use if they are thinking about de-risking
This session will also provide opportunity to audience to get engaged in the consortium project lead by FDA and other industry partners