BIC Best Practice Handbook

Objective

Before biomarker discoveries made in research organizations can be commercially utilized in the clinical laboratory settings, many studies and surveys need to be completed and many questions answered. Is there a market need? Can enough scientific and clinical evidence be generated to convince the end users? Is the biomarker patent protectable? Can the invention be transferred into a practical product and produced at a scale that makes sense financially?

Although commercial product development is not the focus of academic research, understanding the requirements of the industry and real-life end users are prerequisites for the successful commercialization of new biomarker assays.

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 input for the collection has been sought from true-life practices which have led to success; practices found in literature and taught by experts in the field; opinions, expertise and experience of the different stakeholders (incl. end users, companies, TTOs, researchers, financiers), recommendations found in guidance, regulation or laws, as well as practices learned the hard way, i.e. repeatedly failing somewhere in the process and later adapting the process for increased success.

The best practices mainly include practices that are prerequisites for successful commercialization, but also practices that have been found to promote IVD-applicable biomarker commercialization.

The pitfalls are often the reasons why the commercialization fails and are of course something that should be avoided. These can relate for example to items or data that is missing or suboptimal, typical obstacles or failures somewhere else in the process (e.g. in patenting), or pieces of advice received from the industry partners or end users.

The main target group for the handbook is people involved with technology transfer, such as the personnel of Technology Transfer Offices (TTOs). However, the presented practices are not intended to be interpreted as strict rules but rather a source of inspiration. Optimal ways to proceed with patenting and commercialization significantly vary between cases and circumstances.

BIC Best Practice Handbook

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