Biomarker Commercialization – IVD applicable Biomarker Research and Innovation implementation Development GuidE

BiC BRIDGE

PROGRAMME 2014-2020

priority

1 Innovation

objective

1.3 Non-technological innovation

BiC BRIDGE

BiC BRIDGE helped smaller players of the biomarker development sector to streamline their biomarker development, and provided guidance, both on the regulatory framework and on the necessary steps linked to commercialisation.

The challenge

Biomarkers, or markers providing information on the health status of a person, measure cellular, biochemical or molecular changes in human tissues as well as cells or fluids. They contribute to future diagnostics and treatment. The development of biomarkers is time consuming and expensive, requiring the involvement of industry from early stages to better direct the research. Researchers lack the knowledge of complex commercialization processes and small and medium-sized enterprises (SMEs) have poor understanding of regulatory frameworks.

BIC BRIDGE built on the tools developed by the project BIC.

Budgets

BiC BRIDGE
in numbers

0.76

Million

Total
0.58

Million

Erdf
0.00

Million

Eni + Russia
0.00

Million

Norway

Achievements

While working directly with the users (SMEs essentially), BiC BRIDGE added two steps to the tool that was already developed within the main project. These steps correspond to the last phases before commercialisation. In practice, this means guidelines to be followed by SMEs when they plan to launch a new test on the market. The commercial goal is thus central in these phases, while the technical and regulatory processes are crucial supportive steps.

BiC BRIDGE has also developed an IVDR (In Vitro Diagnostics Regulatory) roadmap, which allows users to visualize in a dynamic way the regulatory process. It provides a live understanding of the interaction between the technical, commercial and regulatory processes. Finally, the project created an educational toolbox, including several tutorials, access to all recorded webinars, as well as a visual explanation of how to use the BiC tools. The project made sure to shorten the time between the discovery of a biomarker and its market entry also for the future. The long process of patenting, licensing and commercialising a biomarker discovery is now easier and faster.

Outputs

In Vitro Diagnostics Regulatory Roadmap

The BiC In Vitro Diagnostics Regulatory Roadmap is written from the manufacturer's perspective and is a map that provides guidance not only on what to do, but also on how to do it, to start-ups and spinouts with new biomarker-based IVDs, and SMEs with already commercially available IVDs that require re-approval. The Roadmap includes information on: - regulatory strategy - production design and planning - product development - development output - market and follow-up.

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Biomarker Commercialization Guide

The Biomarker Commercialization Guide is a web-based tool offering holistic guidance through them highly regulated and interdisciplinary biomarker development process. It highlights the biomarker development from three perspectives: technical, regulatory and commercial, and follows the process via the technology-readiness levels (TRLs).

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Project Stories

01.12.2020

Commercialising biomarkers faster to improve medical treatment

A project was set into motion in 2017 with the ambitious aim to facilitate and standardize the commercialization process of new biomarkers. Biomarkers are increasingly important in disease risk prediction, diagnosis, prognosis and treatment response. The BIC project concluded in September 2020 and brought about some tools that can help medical companies to bring new biomarkers to the market faster.
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25.04.2022

Enabling the market uptake of biomarkers used in diagnostics and treatment

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