Building Confidence in MPS for Regulatory Applications!  

At the intersection of innovation, collaboration, and science lies an exciting new project led by the 3Rs Collaborative (3RsC) – and CN Bio is one of the collaborators. This effort brings together regulators, technology providers, end-users, and non-profits to advance the responsible use of microphysiological systems (MPS) in regulatory applications. 

In partnership with 3RsC, the FDA Center for Drug Evaluation and Research (CDER), 9 commercial providers, 1 end-user, NIH-NICEATM, and C-Path, we are embarking on a project to evaluate the use of Liver MPS to detect Drug-induced liver injury (DILI). Our goal is to assess variability across multiple platforms using the same experimental protocol, with the ultimate goal of enhancing confidence in the accuracy, reliability, and standardized characterization of these models. 

🔍  Why this matters

This is more than a study. It’s a model for how different stakeholders such as regulators, developers, NIH and pharma end-users, can shape the future of drug development through the use of novel alternative methods. Our approach in this collaboration is focused on obtaining information that is human-relevant, data-rich, and aligned with the 3Rs. 

📈  What we’re doing

  • Testing known hepatotoxicants & their controls across 9 unique, commercially available liver MPS platforms 
  • Using real-world protocols to reflect what regulators might see in real submissions 
  • Analyzing cross-platform data to inform best practices and future guidance 
  • Submitting a collaborative letter of intent to FDA’s Innovative Science & Technology Approaches for New Drugs (ISTAND) program to qualify MPS for a specific context of use 

This is a first-of-its-kind, coordinated effort to harmonize innovation, good science while keeping regulatory considerations in mind—and it’s just the beginning. 

💡 The future of science is collaborative

It highlights scientific rigor, innovation, and ethical considerations. And it’s already underway. 

Participating end-user:

Merck & Co, Inc. 

Participating model developers:

Axiom/LifeNet Health, BioIVT, CN Bio, DefiniGEN, InSphero, Lena Biosciences, Inc., PredictCan, TissUse, Xellar. 

Click the links to find out more about our Liver MPS (also known as Liver-on-a-chip), DILI assays powered by PhysioMimix technology and our cross-species DILI Contract Research Services.