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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

Duration

90 minutes

Agenda

Coming soon.


Moderators and Presenters

Aaron Fullerton, PhD, DABT

Director - Investigative Toxicology, Safety Assessment

Genentech

<h2 class="font_2"><strong>Aaron Fullerton, PhD, DABT</strong></h2> <p class="font_8">Director - Investigative Toxicology, Safety Assessment</p> <p class="font_8">Genentech</p>

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.

<h2 class="font_2"><strong>Aaron Fullerton, PhD, DABT</strong></h2> <p class="font_8">Director - Investigative Toxicology, Safety Assessment</p> <p class="font_8">Genentech</p>

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.

<h2 class="font_2"><strong>Aaron Fullerton, PhD, DABT</strong></h2> <p class="font_8">Director - Investigative Toxicology, Safety Assessment</p> <p class="font_8">Genentech</p>

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.

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