Biomarker

Interviews with researchers and biobanks

“Basic research is not really triggered by the idea of clinical use, and researchers are really not aware of the later challenges in the commercialization process. Researchers don’t understand technical and quality control points of view. It is also challenging to find collaborators, when scientific and commercial interests don’t meet.”

Researchers (n=16)

The interviewed researchers focus mostly on research and have less experience in commercialization procedures, even though some of the interviewees have previously worked in diagnostics companies and cooperated with clinicians. Most ideas of interviewees originate from basic research and professional curiosity, as their biomarker projects have not started with the goal to find a new biomarker but to solve research/patient related problems and researchers don’t have that much knowledge about systematic biomarker development.

Researchers seem to be aware of requirements for a new biomarker (sensitivity, specificity, pricing, sample type, technology etc). As challenges of biomarker commercialization, researchers mention lack of funding and know-how of the process (validation, statistics), long time-line of productization, access to samples and technological problems. Convincing clinicians to use or even to test a new biomarker is also mentioned as a challenge, and more communication between researchers and end-users is hoped.

Regulative aspects are not of interest for many of the interviewees. Only a few have any quality management in their labs, and some think that it is not needed for basic research. “The companies are to follow the IVD regulations, not the scientist, not that strictly.

Based on the answers of what kind of support is needed, researchers would benefit of guidance and training in e.g. IPR issues and quality points of view, systematic product development (e.g. it was not always clear whether the interviewees were talking about clinical validation or PoC, when discussing about milestones in biomarker development), making market and competition surveys, and concrete support in writing patents and contracts. Some interviewees see that support in applying for funding is needed, as only a few of the interviewed researchers have sponsors, and most of the work is financed by public funding or grants from foundations. Some proposals of action for TTOs are listed here:

  • Organizing mentoring, training, expert services (validation process, regulatory aspects)
  • Organizing networking with companies and end-users
  • A clear roadmap on biomarker development with relevant guidelines, quality requirements etc available for researchers

Researchers working with biomarker development prefer direct contacts, networking meetings and conferences and joint projects for matchmaking and communication. Some of interviewees could also be interested in using the BIC biomarker platform for matchmaking and search for support, if it works well.

A good platform could have kind of road map for biomarker development. All the steps presented, expert services offered, local contact points for validation services etc.”

Biobanks (n=2)

The two biobanks that were interviewed see themselves more as service providers than research organizations. They can provide clinical samples and data for research and development of biomarkers to other actors on the field. Services offered by biobanks include e.g. analyses of samples and data, sample collection, and characterization and validation services. The biobanks pay attention to quality management (SOPs), but regulative aspects concerning the further development are seen to be mainly on customers’ responsibility. The both interviewees see that the current trend is turning to use of clinical data in research and product development instead of (just) clinical samples.

Biobanks are interested in collaboration with research institutes, other biobanks and industry/companies. They could use a biomarker platform and attend networking events to find correct contacts for joint projects and to market their services.

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