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.

This session will cover the key components that should be considered when developing a MPS model, such as the context of use, and physical and biological inputs (including cells, matrices and media). Furthermore, the concept of good experimental design for MPS will be presented using a case study example.

Basic 2D monolayer cultures can fail to predict in vivo pharmaceutical candidate properties such as efficacy, ADME, or toxicity as they lack the necessary physical and biochemical cues found in vivo. MPS aim to fill this gap by exploiting advances in material sciences, microfabrication processes, and engineering to recreate the in vivo environment. In this session, technical design considerations of MPS are discussed with respect to:

- Material considerations
- Fluid dynamics in systems with flow
- Mechanical stimuli were applicable
- Device qualification and operation
- Body-on-a-chip configuration
- Immune cell incorporation

With new approach methodologies (NAM) evolving in tandem and at a rapid pace, there is an opportunity to integrate them in ways previously thought impossible. This session aims to initiate discussion on how the diverse and complex datasets derived from CIVM and MPS models may be analyzed using quantitative systems biology (QSP), machine learning, and in silico modeling approaches. Examples will be provided through case studies, and a realistic view of the current gaps as well as future outlooks and opportunities will be discussed.

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 frameworks.

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.