BIC Biomarker Commercialization Tools

Challenge

While there is a lot of research identifying links between some biological signatures (biomarkers) with diseases or response to the treatment, less than 2% will convert into clinical applicable diagnostic test (IVD test). The discovery part is a substantial investment from research institutions, but the route to industrial development and to commercialisation is not part of the skills and expertise easily available in research institutions, even when having a Technology Transfer Office (TTO) to support commercialisation of an invention.

Technology

The BIC project partners have developed a set of tools supporting the process of development and commercialization of biomarkers. The tools include a Biomarker Commercialization Guide, a Best Practices Handbook, an IVD Regulatory Guide, and a Review Tool. The Biomarker Commercialization Guide is a web-based tool, providing guidance through the technology readiness levels (TRL) and covers the clinical, regulatory, and business aspects of the commercialization process. The Best Practices Handbook collects some of the best practices and pitfalls encountered at different phases of biomarker discovery, development, patent protection, and technology transfer. The Biomarker Commercialization Review Tool is a comprehensive checklist for the selection of the most promising invention for further commercialization of IVD-applicable biomarkers. The BIC In Vitro Diagnostics Regulatory Guide introduces researchers and entrepreneurs to a basic understanding of the regulatory process for the CE mark of IVD diagnostics, along with the development of the project toward a clinical product.

Commercial Opportunity

The aim of the tools is to present companies, universities, and research institutions involved in the biomarker development sector with a solution that will help them streamline their biomarker development and provide them guidance, both on the regulatory framework and on the necessary steps linked to commercialisation. The stakeholders can use a common framework that fosters cooperation and provides step by step guidance with the objective of accelerating a new generation of biomarker and companion diagnostics. The tools are freely available at biomarker.nu.

Development Status

The set of tools that was developed during the BIC project period is finalized and freely available. The BIC Bridge extension project aims to expand and further develop these tools. The project will produce an IVD Regulatory Roadmap to help stakeholders navigate through the regulation. It will also create industrial development and commercialisation guidance for the private sector and will upgrade the BIC Biomarker Commercialization Guide into an IT solution, available for all. In addition, BiCBRIDGE will develop a Training Material Toolbox for academia to prepare (future) researchers for commercialisation challenges, as well as for Technology Transfer Offices and professionals for trainings.

Patent Situation

The tools are freely available at biomarker.nu.

Further Reading

Webpage: https://biomarker.nu/.