IQ MPS
IQ Microphysiological Systems Affiliate
An Affiliate of the International Consortium for Innovation and Quality in Drug Development
Module II
Established CIVM/MPS (Organ-Specific Sessions)
CIVM designed to recapitulate organs most frequently impacted by off-target toxicity, such as liver and GI, and therapeutic targets that are difficult to model in vitro, such as lung, have received the greatest attention for their potential to improve clinical translatability. This module will provide a detailed overview of those CIVM models with which the field has the most experience. Each session will focus on a different organ system and utilize case studies to illustrate how pharmaceutical end users are applying these models for internal decision-making and the unique considerations and challenges for qualifying these models for each context of use.
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.
GI (Part I)
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.
GI (Part II)
This session will provide an overview of complex in vitro models specific to the Gastrointestinal tract and how they are being employed for ADME and leveraged for evaluation of alternative therapeutic modalities (T-cell therapy). Speakers will present on three case studies: 1) predicting absorption and intestinal first-pass elimination, 2) modeling oral phosphate prodrug bioconversion, and 3) safety evaluation of T cell-based therapies.
Kidney
This session aims to provide points of view for assessment of kidney function highlighting available complex in vitro models covering contexts of use for safety and ADME properties. Case studies demonstrating nephrotoxicity assessment using microfluidic device-based and immune-competent kidney models will be presented. Additionally, the CIVM landscape for Kidney will be discussed to address gaps remaining in modeling renal physiology.
Lung
This session provides a comprehensive overview of the complex in vitro models (CIVMs) commonly employed by lung safety teams in the drug development process. Participants will gain a thorough understanding of the functional characterization of these models and how they are rigorously qualified for use through testing with tool compounds known to exhibit lung safety liabilities.
Through real-world case studies, we will explore different contexts of use, specifically focusing on the decision-making process for choosing between transwell, organoid and organ-chip models. This will include in-depth discussions on the critical role of cell sourcing and characterization in establishing trust and confidence in these models.
