Cambridge, UK: CN Bio, a leading Organ-on-a-Chip (OOC) company that designs and manufactures single-and multi-organ microphysiological systems (MPS), has received the ‘Most Impactful Industry Collaboration of the Year’ at the 2023 OBN Awards. The award recognises the ongoing success of the Company’s collaboration with the U.S. Food and Drug Administration (FDA), aimed at advancing OOC adoption through evaluation of its PhysioMimix® OOC range of MPS across a series of applications in drug discovery and development.
Around 90% of drug candidates reaching clinical trials fail, often due to poor clinical translatability between conventional animal models and humans. Coupled with increasing awareness around ethical considerations and the increasing cost of animal studies, there is growing interest in New Approach Methodologies (NAMs), such as OOC, to provide effective, predictive preclinical models. Recent ground-breaking legislature, including the US Government’s FDA Modernization Act and similar acts from the Canadian Government have supported this.
However, a lack of published data demonstrating OOC technology in comparison to other, long established preclinical models has impacted its widespread adoption into drug discovery and development programmes. To overcome these challenges, in 2017, the FDA selected CN Bio as a collaborative partner, to harness its 14+ years OOC expertise in a ground-breaking research partnership aimed at evaluating the accuracy and reproducibility of MPS relative to standard practices. The successful study led to the publication of the first co-authored, peer-reviewed article between an MPS provider and a regulator, and general recommendations for the use of liver MPS technology during drug discovery workflows. Since then, the breadth and scope of the study has been expanded twice to investigate additional models for increasingly complex studies that aim to better inform decision-making at an earlier stage of drug discovery, gain deeper mechanistic insights to refine in vivo study assay design and reduce requirements for animal models. Further publications are anticipated.
The OBN Awards, now in their 15th year, are a highly regarded and sought-after awards programme for the Life Sciences industry, designed to celebrate innovation and outstanding achievement across all corners of the industry. Sponsored by Mills & Reeve, the award for ‘Most Impactful Industry Collaboration of the Year’ recognises companies that have successfully engaged in partnerships that have shown a dynamic impact on R&D which stands to benefit patients.
Dr. Tomasz Kostrzewski, Chief Scientific Officer, commented: “It is a huge honour to have received Most Impactful Industry Collaboration of the Year at this year’s OBN Awards. By working closely with the FDA, our aim is to highlight the impact that this research could have on the global NAM market.” He added: “The data so far further asserts the utility of our OOC technology to provide accurate and reproducible data, encouraging MPS adoption into drug discovery and development workflows, positioning the technology as a viable alternative to animal models, where suited. Taken together, the collaboration’s ever-growing scope is helping to pave the way for global regulatory bodies to rewrite legislature around animal testing requirements, and open up possibilities for accurate, human-relevant preclinical models that can bring more effective treatments to patients who need them.”
- ‘Characterizing the Reproducibility in Using a Liver Microphysiological System for Assaying Drug Toxicity, Metabolism and Accumulation’, Clinical and Translational Science https://ascpt.onlinelibrary.wiley.com/doi/10.1111/cts.12969
