Biomarker

Interviews with clusters

Biomarkers mainly supported by standard cluster tools, very little cluster specific efforts. Clusters may play a role in regional agenda setting promoting biomarkers if BiC can deliver USP’s and trans-national complimentary tools.

Experience and cluster support to biomarker development

  • Cluster support to biomarker development: Policy influencing, regulatory guidance, overview of competencies, market research, match making, connecting academia and industry, internationalization support, marketing, networking, identifying project funding sources,
  • Cluster priority: Most do not work directly with biomarkers. Only Biopeople has biomarkers as a specific topic they work on.

Conclusion: Biomarkers mainly supported by standard cluster tools, very little cluster specific efforts. Clusters may play a role in regional agenda setting promoting biomarkers if BiC can deliver USP’s and trans-national complimentary tools.

Milestones in biomarker commercial development

  • Identify market need and market size and understand reimbursement system
  • Find a customer to finance development, validation and market awareness.
  • Getting access to the clinics for testing
  • Validation the top priority.
  • Most important is the Phase III in clinical trials
  • Be aware of the high costs of marketing – more expensive than the development phase
  • Preparing a business model and business plan
  • Do not forget the regulatory part.
  • Get the marketing and sales force in place

Conclusion: What can a trans-national platform assist with? Maybe (1) market and reimbursement insight (2) match making between academia and paying customer (3) trans-national access to courses and training (4) trans-national access to competencies

Economy and reimbursement

  • Despite CE regulation, each country has own additional rules
  • High cost of biomarkers not a hindrance if benefits are even larger

Conclusion: A trans-national platform may facilitate access to knowledge on different reimbursement systems. Market analysis crucial to argue for the relevance of high biomarker costs

Translation to clinical setting

  • Early involvement of industry important

 

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