BioSafe/DruSafe Emerging Technologies: Real-Life Experiences w/Microphysiological & Organoid Systems

March 31, 2016

Workshop

BioSafe/DruSafe Emerging Technologies Workshop:  Real-Life Experiences with Microphysiological and Organoid (3D) Systems

Room 2058, USFDA, Silver Spring, MD

This workshop will provide an exchange of the ‘real-world’ experience of the evaluation and use of ‘organ-on-a-chip” and organoid (3D) platforms from pharmaceutical industry.  This will include discussion of the drivers for their evaluation, qualification/validation approaches, application for screening or investigation of toxicology, DMPK and pharmacology questions, and the experiences gained regarding advantages, disadvantages, challenges, and limitations.  The topics will include an overall perspective and update on the collaboration between NCATS and the IQ Consortium; hepatotoxicity cross platform evaluation of small molecules and ADCs; drug disposition modeling; development of a thrombosis model; and application to cardiac safety.  The session is meant to be interactive and will end with a panel discussion.