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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

Thursday, September 28, 2023 at 10:00 AM ET

Duration

90 minutes

Agenda

Welcome and Introduction

Aaron Fullerton, Genentech


How will CIVMs Utilize the Existing Qualification Framework?

Aaron Fullerton, Genentech


A Microphysiological Skeletal Muscle Platform for Disease Modeling and Pharmacology

Christopher Hinckley, Biogen


Q&A

Lindsay Tomlinson, Pfizer


Safety at the Forefront: Challenges and Strategies for Establishing Liver CIVM/MPS

Leah Norona, Genentech


Q&A

Lindsay Tomlinson, Pfizer


Session Slides:


IQ MPS PharmTox Training Module 1 Sesssion 5
.pdf
Download PDF • 7.98MB

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>

Lindsay Tomlinson, DVM, DVSc

Global Pathologist Resource Lead

Pfizer, Inc.

Lindsay Tomlinson has over 22 years of toxicologic pathology and project experience in the pharmaceutical industry. She holds a DVM and DVSc from the Ontario Veterinary College and is board certified with the American College of Veterinary Pathologists (ACVP) in anatomic and clinical pathology and the American Board of Toxicologists (ABT) in toxicology. In her current role as Global Pathologist Resource Lead for anatomic and clinical pathologists at Pfizer, she supports the development of mRNA vaccines and the adoption of digital pathology technologies, including the development and incorporation of complex in vitro models into the standard testing paradigm and applications of artificial intelligence in toxicological pathology assessments. Lindsay is also an active member of several professional societies, previously serving as President of the American Society for Veterinary Clinical Pathology (ASVCP) Executive Board, Chair of the ASVCP Regulatory Affairs Committee, member of the Society of Toxicologic Pathology (STP) Executive Committee, Chair of the STP Scientific and Regulatory Policy Committee, and member of the INHAND (International Harmonization of Nomenclature and Diagnostic Criteria) Project on female reproductive pathology.

<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

Associate Director

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 is a scientist in the Investigative Toxicology Group within the 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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