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Introduction to CIVM and MPS

This session will provide an overview of the objectives and content of the IQ MPS Affiliate Training course followed by an overview of MPS platforms and how the pharmaceutical industry is currently using these and other Complex In Vitro Models.

Date & Time

Thursday, July 13, 2023 at 10:00 AM ET

Duration

90 minutes

Agenda

Welcome and Introduction

Nakissa Sadrieh, CDER/FDA


Development of CIVM/MPS Models and Overview of Course Outline

Aaron Fullerton, PhD, DABT, Genentech


Industry use of CIVM/MPS: IQ MPS Affiliate 2019/2021 Landscape Survey Highlights

Anna K. Kopec, PhD, Pfizer, Inc.


Q&A


Session Slides:


IQ MPS_PharmTox Training Module 1 Session 1 - Introduction and Pharma MPS Use
.pdf
Download PDF • 7.38MB

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>

Anna K. Kopec, PhD

Director, Investigative Toxicology

Global Discovery, Investigative & Translational Sciences

Drug Safety R&D

Pfizer, Inc.

Anna is a Director of Investigative Toxicology group at Pfizer and 2022-2023 IQ MPS Affiliate Vice Chair. She received a dual major PhD in Biochemistry & Molecular Biology and Environmental Toxicology from Michigan State University studying effects of xenobiotic exposures and investigating mechanisms linking coagulation and liver repair in models of liver injury. In her role at Pfizer, she provides strategic guidance on the qualification and context-driven application of novel complex in vitro models.

<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>

Nakissa Sadrieh

Senior Advisor for New Alternative Methods

CDER/FDA

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