IQ MPS
IQ Microphysiological Systems Affiliate
An Affiliate of the International Consortium for Innovation and Quality in Drug Development
Liver
This session will cover the functional readouts and reference ranges for key liver complex in vitro model parameters. We will introduce relevant COUs and highlight liver MPS model characterization and proof-of-concept data for DMPK and safety testing. Additionally, the value of liver MPS in replicating species-specific toxicity that was not reproducible using traditional in vitro systems (i.e., 2D plated hepatocytes) will be discussed.
Date & Time
Thursday, October 3, 2024, 10:30 AM ET - 12:30 PM ET
Duration
120 minutes
Agenda
Welcome and Module II Introduction
Aaron Fullerton (Genentech)
Nakissa Sadrieh (FDA)
Module I (Introduction to CIVM/MPS) Recap
Aaron Fullerton (Genentech)
Introduction to Liver CIVM/MPS: Model Features, Technical Considerations, Functional Readouts, and Relevant COUs
Leah Norona (Genentech)
Case Study: Establishing and qualifying a human liver-chip for DMPK and safety purposes
Benoit Cox (UCB)
Case Study: Interrogating potential FMO-mediated species-specific toxicity of a histamine receptor antagonist using rat and dog liver chips
David Kukla (AbbVie)
Q&A / Discussion
Alexa Rizzolo (Bristol Myers Squibb)
Rachelle Prantil Baun (Novo Nordisk)
Sowmya Balasubramanian (Astellas)
Qiang Shi (FDA)
Frederic Moulin (FDA)
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.
Nakissa Sadrieh, PhD
Senior Advisor for New Alternative Methods
CDER/FDA
Alexa Rizzolo, PhD
Scientist
Bristol Myers Squibb
Alexa is currently a Scientist in Discovery Toxicology at Bristol Myers Squibb where she supports the identification and management of toxicological liabilities using in vitro systems. She received her doctorate in Toxicology from Rutgers University. Prior to pursuing her PhD, she worked at Scripps Research Institute in the department of Immunology and at GlaxoSmithKline in the department of Investigative and Mechanistic Toxicology.
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.
David Kukla, PhD
Senior Scientist
AbbVie
David is currently a scientist in the quantitative, translational, and ADME sciences group (formerly DMPK) at AbbVie where he supports hepatocyte metabolic studies for clearance and reaction phenotyping using liver CIVM and MPS. He received his doctorate in Bioengineering from the University of Illinois at Chicago and his bachelor’s in Materials Science and Engineering from the University of Illinois at Urbana-Champaign.
Benoit Cox, PhD
Senior Scientist
UCB Biopharma SRL
Benoit is a Senior Scientist in the in vitro ADME team at UCB where he supports metabolic and permeability studies using traditional models and CIVM. Previously, he developed a human liver-chip model during a postdoc at UCB. He obtained his Master of Drug Development and PhD in Biomedical Sciences at the University of Leuven in Belgium.
Rachelle Prantil Baun, PhD
Principal Scientist
Novo Nordisk
Rachelle is currently a Principal Scientist in the Micro-physiological Systems department at Novo Nordisk, leading the Liver MPS efforts. She has a PhD in Biomedical Engineering and has worked extensively with in vitro systems for multiple drug discovery purposes. Rachelle led disease modeling efforts for Organs On Chips at the Wyss Institute for 6 years and has also worked in RNA and DNA based therapies at Pfizer and Intergalactic Therapeutics.
Sowmya Balasubramanian, PhD
Senior Scientist
Astellas
Sowmya is a member of the translational science team within Astellas' engineered small molecules division leading pre-clinical biomarker initiatives and facilitating MPS-based studies across programs. In her previous positions, Sowmya has acquired expertise in characterizing the biology of complex in vitro systems and establishing in vitro platforms to enhance drug discovery endeavors.