The BIC Guide should provide guidance throughout the biomarker development process and should be a tool to monitor the progress of the biomarker development process actively.

In the web version of the tool, you will have access to the phases and tasks of the biomarker commercialization that were identified through the feedback from biomarker developing company representatives, biomarker developing scientists, investors and other stakeholders. The tasks are described and partially supported by useful, downloadable documents. The tool addresses analytical and clinical topics, as well as commercial and regulatory topics in the biomarker field.

Do you want to have a look at the current version of the BIC Guide?

Please contact your local contact partner!

The BIC Best Practice Handbook collects some of the best practices and pitfalls encountered at different phases of biomarker discovery and development, as well as patent protection and technology transfer at universities, hospitals and research organizations. The handbook focuses on in vitro diagnostics (IVD)-applicable biomarkers, i.e. markers that could potentially be examined in clinical specimens to provide information on the health status of a person in the healthcare or home settings.

The BIC Best Practice Handbook is now available!

The BIC ReviewTool is a tool for choosing the most innovative/commercializable biomarker projects. It is dedicated to TTOs (technology transfer offices) and business developers working with biomarker projects. The tool covers aspects of the biomarker commercialization process to consider, and technical parameters to accomplish in order to run effective commercialization and place IVD devices on the market. The BIC ReviewTool enables to check the maturity of the project developed so far, against a set of characteristics on biomarkers, planned tests, target population, position in the clinical care life-cycle, clinical performance of the test, checks on prototype and IPR issues.

The tool should provide guidance throughout the biomarker development process and should be a tool to monitor the progress of the project development and select biomarker projects with the biggest commercial potential at an early stage.

Do you want to have a look at the current version of the BIC ReviewTool for TTOs?

Please contact your local contact partner!

The BIC Regulatory Guide was created to extend, organize, and systematize knowledge in the area of regulatory affairs. It should support stakeholders, who participate in process of placing IVD biomarker products on the market.

The BIC Regulatory Guide will be available soon!