IQ Microphysiological Systems Affiliate
An Affiliate of the International Consortium for Innovation and Quality in Drug Development
CIVM/MPS Qualification Considerations and Challenges
This session will provide an overview of qualification efforts for the use of CIVMs in various contexts of use and will include both a high-level overview of the current qualification landscape as well as examples of internal fit-for-purpose qualification efforts within Pharma companies for different contexts of use and discuss how these complex models present unique challenges to using traditional assay validation framework.
Date & Time
To Be Announced
Moderators and Presenters
Aaron Fullerton, PhD, DABT
Director - Investigative Toxicology, Safety Assessment
Aaron Fullerton leads the Investigative Toxicology laboratory within Safety Assessment at Genentech which is focused on the use of in-vitro models to support candidate selection and pre-clinical safety evaluation of a wide variety of therapeutic modalities in the Genentech portfolio. CIVM and MPS approaches comprise a major component of these tools leveraged alongside traditional in-vitro models to provide comprehensive understanding of safety liabilities, mechanisms of drug toxicity and translatability of safety findings from in-vivo pre-clinical animal studies.
Christopher A. Hinckley, PhD
Principle Scientist, Biogen
Chris Hinckley is a neuroscientist with over 5-years of experience managing preclinical and clinical stage programs across various drug modalities. Chris is also engaged in cutting-edge use of human cellular models of rare neurological and neuromuscular diseases and is a dedicated manager and mentor to a growing team of researchers.
Leah Norona, PhD, DABT
Senior Scientist, Genentech
Leah Norona, PhD, DABT, is a Senior Scientist in the Investigative Toxicology Group, Department of Safety Assessment at Genentech. She has a broad interdisciplinary background in toxicology and expertise in the development and strategic implementation of novel in vitro models to understand complex mechanisms underlying drug-induced liver injury (DILI). In her current role, she oversees the screening and mechanistic evaluation of molecules for DILI risk to support various aspects of the discovery and development pipeline.