Excellent medicine relies on fresh research and new biomarkers
The discovery of biomarkers is giving rise to new areas of diagnostic and treatment, thereby improving human health. The global biomarkers market expects to reach a market value of $53.3 billion by 2021 of which healthcare and R&D expenditure are the key growth drivers (source: “Biomarkers Market - Global Forecast to 2021”). A biomarker is a very broad term for something that can be tested to confirm the presence or absence of a disease, e.g. proteins produced by our own cells or by invaders or antibodies which our immune system produces to fight off diseases.
Fresh research results often do not reach companies
However, the development and commercialization of biomarkers is time consuming, complicated, and expensive. At the beginning of the project, there was no proven routine to bring biomarkers to the market successfully. “Even though new biomarkers are being identified in laboratories all the time, not many make it past a scientific publication”, explains Allan Stensballe, professor at Aalborg University in Denmark. Tero Piispanen, senior executive at Turku Science Park Ltd., Finland, adds that “Researchers need guidance to select the most relevant biomarker discoveries and conduct a development plan that meets the early requirements from relevant industry partners, such as pharmaceutical and diagnostic enterprises, SMEs, and investors”.
Diverse competences and experiences are needed
These challenges have paved the way for the Biomarker Commercialization (BIC) project, led by a consortium of eight partner organisations: hospitals, universities and science parks from the Baltic Sea region. "The transnational cooperation was crucial for the success of this project," explains Valerie Daussin from the innovation department of the University Hospital of Aalborg in Denmark, who leads the project consortium. "At the university hospital, we identified a need for developing a specific working method on biomarker development, but we couldn't improve it on our own.” Experiences and focus on biomarker inventions amongst Danish colleagues were very limited. “The Interreg project brought together and opened doors to relevant international partners with very strong and diverse competences who were already experienced in bringing biomarkers to the market,” Valerie highlights.
Leading researchers into a product-mindset
With the objective of bringing new and better biomarkers for in-vitro diagnostics more efficiently from discovery into clinical use, the BIC consortium developed a set of tools. The purpose of the tools is to lead the researchers, such as medical students, biochemists or molecular biologists, into a product-mindset from the beginning when doing their research and to offer guidance through the highly regulated and strict development phases of the development process.
Step by step guidance: discovery - prototype - commercial launch
The first of four biomarker commercialization tools that were published in Summer 2020, is a web-based tool available on biomarker.nu, the Biomarker Commercialization Guide. The BIC Guide supports academic researchers and SMEs when developing an in-vitro diagnostic biomarker invention to a commercial product. It provides guidance through the technology readiness levels and covers the clinical, regulatory, and business aspects of the commercialization process. Eight researcher teams, six SMEs and two technology transfer offices from Denmark, Estonia and Finland tested the guide.