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Session 11

In Vitro Microphysiological Systems – From Concept to Regulatory Acceptance

Programme of the Session

  • Organs-on-chips for vascular function 
    Andries Van der Meer 
    MIRA Institute for Biomedical Technology and Technical Medicine, University of Twente, Enschede, Netherlands
  • Applications of microphysiological systems in the pharmaceutical industry 
    Tommy Andersson 
    Innovative Medicines and Early Development Biotech Unit, AstraZeneca, Gothenburg, Sweden
  • Determining the predicative ability of in vitro microphysiological systems to answer critical regulatory questions 
    Suzanne Fitzpatrick
    Center for Food Safety and Applied Nutrition, US Food and Drug Administration, College Park, United States
  • Combining organs on a chip – a roadmap towards “humans-on-a-chip” 
    Uwe Marx 
    TissUse GmbH, Berlin, Germany
  • Human multi-organ-chips (MOCs) from vison to acceptance by industry and regulators
    Horst Spielmann1, Uwe Marx2

    1Pharmacy, Freie Universität Berlin, Berlin, Germany; 2TissUse GmbH, Berlin, Germany

Session Abstract

Organ-on-a-Chip and Body-on-a-Chip microdevices that reconstitute tissue-tissue interactions critical to organ and systemic functions can expand the capabilities of cell culture models and provide low-cost alternatives to animal toxicology studies. With simplified designs and careful choice of biocompatible device materials, they can potentially be used for a variety of applications: from high-throughput analysis and screening of cellular responses to determining systemic effects of drugs, chemicals, particulates, toxins, pathogens, or other environment stimuli relevant to pharmaceutical, cosmetic, and environmental applications.
As the science of in vitro microphysiological systems develops, it is also imperative that regulators dialogue on what they need to have confidence in the predicative capacity of these new and exciting models.  This symposium presents a pathway for building this confidence by first developing confidence in each of the different integral parts of the model and then combining these together for a “context of use” evaluation of its overall predictive ability to answer critical regulatory questions.
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