IQ MPS 

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Developed through a public–private partnership established in 2020 between the IQ Microphysiological Systems (IQ MPS) Affiliate and the U.S. Food and Drug Administration's Center for Drug Evaluation and Research (FDA/CDER), and informed by scientific perspective from the European Commission Joint Research Centre (EU-JRC), the MPS Training Course was created to build a shared scientific understanding of complex in vitro models (CIVM) and support their appropriate application in drug discovery, development, and regulatory science.

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Complex in vitro models—including organoids, microphysiological systems (MPS), and organ-chips—are an emerging class of New Approach Methodologies (NAMs) designed to better recapitulate human physiology than traditional two-dimensional cell culture models. By incorporating multicellular environments, three-dimensional architecture, biomimetic matrices, mechanical and biophysical cues (e.g., flow, perfusion, and tissue stretch), and immune-relevant cellular components, these technologies provide increasingly human-relevant approaches for evaluating drug efficacy, absorption, distribution, metabolism, and excretion (ADME), and preclinical safety. As the field continues to evolve, CIVM are becoming valuable tools for generating decision-enabling data throughout drug development while supporting efforts to replace, reduce, or refine animal use where scientifically appropriate.

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The course provides a structured, module-based curriculum that reflects how pharmaceutical scientists design, characterize, qualify, and apply CIVM within defined contexts of use. Participants gain practical instruction in cell sourcing and model construction, experimental design, biological endpoints, reproducibility and performance considerations, and approaches to model qualification. Real-world case studies demonstrate how pharmaceutical companies use CIVM to inform decisions across efficacy, ADME, and preclinical safety while highlighting both the opportunities and current limitations of these technologies.

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Originally developed to support regulatory familiarity with and consistent interpretation of CIVM-derived data in regulatory submissions, the course has been accessed by regulatory reviewers and assessors from FDA, EMA, MHRA, PMDA, and CDE. It is now available to the broader scientific community—including pharmaceutical and biotechnology scientists, technology developers, academic researchers, and regulatory professionals—to foster a shared scientific foundation and promote harmonization of scientific and regulatory approaches for evaluating and qualifying CIVM across diverse contexts of use.

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Upon completion of the course, participants will have a strong foundational understanding of how complex in vitro models are designed, characterized, qualified, and applied in drug development, and the scientific principles needed to evaluate CIVM-derived data in a scientifically informed and consistent manner.