Interviews with clusters
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