IQ MPS
IQ Microphysiological Systems Affiliate
An Affiliate of the International Consortium for Innovation and Quality in Drug Development
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
Moderators and Presenters
Aaron Fullerton, PhD, DABT
Director, Investigative Toxicology, Safety Assessment
Genentech
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.
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.
Nakissa Sadrieh
Senior Advisor for New Alternative Methods
CDER/FDA