Framework for establishing a Danish biomarker development infrastructure. The Danish Biomarker Network The Aim: To promote a Danish national initiative on development and application of biomarkers for the benefit of industry, patients and health care providers. Background: • Many other countries (e.g. UK, NL, CAN) have or are currently establishing similar initiatives. • F&I-support to the project: Biomarkers as an Emerging Growth Area in Denmark. • The Innovation Foundation is participating in building up a European initiative (ICPerMed), where 28 countries and the European Commission is to promote the development of Personalized Medicine in Europe. • Several other Danish initiatives with relevance for biomarker development: NEXT-partnership BREATHE project EUPATI-DK MVA Oncology Network The Danish Biomarker Network ”Danske Regioner” - Personlig Medicin initiativ Biomarkers as an emerging growth area in Denmark Draft proposal for Biomarker Development infrastructure. Biomarker Development needs defined by: Patients Pharma/Biotech The Danish Biomarker Network Health care providers Counsel for Biomarker Development: Prioritization and guidance in biomarker development Evaluation of new biomarkers. Clinical benefits. Regulatory issues. Ensuring implementation of well Improved patient segmentation Health economic evaluation. documented biomarkers in practice. in clinical trials. CDx validation. Is there a business case? Elements of an infrastructure for Biomarker Development in Denmark Technology Biobanks Bioinformatics/ICT Clinical demands Patient organisations platforms cohorts Big Data practical compliance - e.g. NGS, IHC, MS wearables implementation patient priorities qPCR MAPPING of stakeholders in project ”Biomarkers as an emerging growth area in Denmark” - Stakeholders in the Value Chain of Biomarker Development: Research Validation/Development Clinical implementation in diagnostics & treatment PUBLIC/PRIVATE PARTNERSHIP Biomarkers as an emerging growth area in Denmark 2 Partnership Model The Danish Biomarker Network Information and communication technology ICT Mission To strengthen the development of Personalised/precision medicine User centricity and companion diagnostics in Denmark Research Clinical Development Biomarkers as an emerging growth area in Denmark The Boost4Health project Main features INTERREG V B North West Europe Programme A European project with 10 partners + 1 sub- partner From 7 countries (NL, FR, UK, DE, BE, ES, DK) Led by Brabant Development Agency (BOM) 41 months : 25 Feb 2016 - 31 Jul 2019 €4.5M total budget SME support The SME receives access to international growth support: SME Intake conversation by Tailored coaching Growth Intermediary 1 programme Access to product 2 validation network SMEs receives support Matchmaking in from peers for their 3 service exchange international growth ecosystem Small scale financing 4 €500 – €7,500 In return, the SME provides services to other SMEs in the ecosystem Biopeople Denmark’s Life Science Cluster Biopeople, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark Biopeople representatives in B4H • Randi Krogsgaard, Communication Manager • Niels Westergaard, Manager Advisor for Biopeople in B4H-project • Petter Hartman, CEO Medicon Valley Alliance .