C-Path has developed a framework to support FDA qualification of CIVMs for use in regulatory submissions.
Complex in vitro models (CIVMs), such as microphysiological systems (MPS), organoids, spheroids and organ/tissue-on-a-chip, present an opportunity to enhance the efficiency and accuracy of drug discovery and development in an ethical manner.
The Critical Path Institute (C-Path), a nonprofit organization created to improve drug development, has been working to facilitate the adoption of MPS as drug development tools (DDT) in regulatory science.
At this year’s Society for Laboratory Automation and Screening (SLAS) annual meeting, Dr. Graham Marsh, scientific director at C-Path, presented the organization’s framework to support a US Food and Drug Administration (FDA) qualification of CIVMs for use in regulatory submissions.
Technology Networks had the pleasure of speaking with Marsh to discuss how the framework was developed and how automation and AI can increase the confidence in CIVMs.
Read the piece in its original format in Technology Works here.
