The need to translate results from basic to clinical research arises from the nature of initial in vitro experiments, which are simplified models of the more complex clinical setting. For example, primary chondrocytes cultured in single-cell layers with serum have different conditions and are less clinically relevant than chondrocytes scattered in a dense ECM in the articular cartilage of a human joint. Ex vivo cultures have slightly greater clinical relevance than in vitro experiments due to their more natural ECM environment, but are also more complex and can be more difficult to manipulate experimentally. Nordic's models aim to approximate the high throughput of intro studies and the superior translation of in-models by characterizing cellular function in a more transferable 3D environment. Of course, ex vivo models are still grown under artificial conditions in the laboratory and should be supported by in vivo and clinical research.
Current models and the translational gap
A wide range of in vitro models are commonly used to test the effects of targets and the stability of profiles, and to test cellular modulation. What many of these models have in common is that they lack the necessary complexity and profiling of downstream effects on tissue, making them less suitable for translational application further down the drug development chain.
From arthritic diseases to various forms of fibrosis and cancer, the need for translational models that can accurately profile the extracellular matrix and support decision-making in clinical development is becoming increasingly important.
Nordic Bioscience's translational models use ex vivo, fibroblast, or primary cell cultures cultured in or on appropriate matrices, allowing active profiling of tissue turnover using protein fingerprint biomarkers. For example, an in vitro NAFLD model won't provide the same depth of information as an ex vivo model would:
- Quantitative and dynamic measurement of tissue turnover
- In vivo replication where cells are maintained in a near-native matrix.
- Translational from in vitro to the clinic, allowing the same biomarker to be used at different stages of development.