Microphysiological systems in early stage drug development: Perspectives on current applications and future impact

Area of Science:

• Biomedical Engineering
• Drug Discovery
• Toxicology

Background:

• Microphysiological systems (MPS) show promise for standardized, physiologically relevant testing of drug candidates.
• Despite potential for improved clinical translation, pharmaceutical industry and regulatory adoption of MPS is slow.
• Gaps in understanding MPS strengths and limitations hinder their widespread use.

Purpose of the Study:

• To review advances in microphysiological systems (MPS) research across key organ systems (liver, intestine, vascular, kidney, lung).
• To highlight the context of use for MPS and their potential added value in drug development.
• To discuss the challenges and requirements for successful MPS implementation, including qualification and reproducibility.

Main Methods:

• Review of recent advancements in microphysiological systems (MPS) research.
• Focus on specific organ systems: liver, intestine, vascular, kidney, and lung.
• Analysis of the context of use and added value of MPS compared to existing methods.

Main Results:

• MPS research is advancing, offering more predictive models for drug testing.
• Examples illustrate the application of MPS in various organ systems.
• MPS must demonstrate added value over current methods and be qualified for specific uses.

Conclusions:

• Collaboration between consortia and regulators is crucial for MPS adoption.
• MPS need to be reproducible and qualified for specific contexts to gain trust.
• Successful implementation of MPS can reduce animal use in nonclinical research (3Rs).