Background

Microphysiological systems (MPS) are potentially transformative models that may offer unique insights into drug efficacy and safety and could be more predictive of in vivo biology than the in vitro models currently used in drug discovery and development. MPS are designed to mimic physiologically relevant functions of human or animal organs and tissues. The IQ MPS affiliate defines MPS as going beyond traditional 2D culture models by including several of the following design aspects: a multicellular environment within biopolymer or tissue-derived matrix; a 3D structure; the inclusion of mechanical cues such as stretch or perfusion for breathing, gut peristalsis, flow; incorporating primary or stem cell derived cells; and/or inclusion of immune system components. 1

MPS have promising applications in mechanistic pharmacology or toxicology investigations, preclinical safety screening, and evaluation of drug disposition that could ultimately improve the translational success of drug candidates into the clinic, with the additional potential benefit of impacting the 3Rs (replacing, reducing, and refining animal use) in preclinical studies. Over the last decade the sophistication and capabilities of these tools have matured dramatically and the landscape has become more diverse and increasingly complex.

Yet, a number of challenges remain before these technologies can be fully incorporated into drug discovery and development, with one of the most critical being establishing robust qualification packages built around specific contexts of use (COUs). Focused efforts to characterize performance and assess the analytical validity of new tissue platforms will be needed to build a high level of confidence in the technologies in order to drive industrialization, advance regulatory acceptance and fully realize the promise of MPS.

To address these challenges and support the implementation of MPS in drug development, a group of pharmaceutical and biotechnology companies came together under the International Consortium for Innovation and Quality in Pharmaceutical Development to establish the IQ MPS affiliate.

The IQ MPS Affiliate aims to achieve the following:

Adapted from Dash and Proctor (2019) Hepatic microphysiological systems: Current and future applications in drug discovery and development. In Micro and Nano Technologies, microfluidic Cell Culture Systems (2nd Ed) Elsevier, 2019.

Serve as a thought leader for both MPS developers and stakeholder organizations in the industry implementation and qualification of MPS models.

Provide a venue for appropriate cross-pharma collaboration and data sharing to facilitate industry implementation and qualification of MPS models.

Create focused engagement between industry and regulatory agencies on the current status and evolving field of MPS in an industry setting.

Develop external partnerships and collaborations to help enhance the inclusion of industry priorities.

1 Fabre, K., Berridge, B., Proctor, W. R., Ralston, S., Will, Y., Baran, S. W., ... & Van Vleet, T. R. (2020). Introduction to a manuscript series on the characterization and use of microphysiological systems (MPS) in pharmaceutical safety and ADME applications. Lab on a Chip, 20(6), 1049-1057.