“We are happy to announce that the Best Practices and Pitfalls in Commercializing IVD-Applicable Biomarkers Handbook is now available from biomarker.nu webpage. The handbook is the first of four biomarker commercialization tools that are being published this summer by the Biomarker Commercialization (BIC) project consortium with the objective of bringing new and better IVD-applicable biomarkers more efficiently from discovery into clinical use”, tells the main author of the handbook, Dr. Piia von Lode, Innovation Manager at the University of Turku, Finland.
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CONTENTS
LIST OF ABBREVIATIONS
1 INTRODUCTION
2 CLINICAL IMPACTS OF IVD-APPLICABLE BIOMARKERS 2.1 Biomarker definition 2.2 Clinical need 2.3 Clinical utility and clinical benefit 2.4 Economic evaluations
2.5 Other impacts of testing
2.5.1 Social, psychological, ethical and legal impacts
2.5.2 Logistical considerations
3 THE IVD-APPLICABLE BIOMARKER PIPELINE
3.1 Candidate discovery and biomarker verification studies
3.1.1 Clinical specimens
3.1.2 Statistical versus clinical significance
3.1.3 Compliance with regulatory requirements
3.2 Specific assay development
3.2.1 Establishing a prototype in a specific assay platform
3.2.2 Analytical performance characteristics
3.2.3 Clinical performance characteristics
3.3 Diseases with no existing biomarkers
4 COMMERCIALIZATION ASPECTS
4.1 Market research
4.2 Market potential
4.3 Competition analysis
4.3.1 Alternative biomarkers and assay formats
4.3.2 Self-competition
4.4 Commercialization pathways and marketing
5 INTELLECTUAL PROPERTY RIGHTS (IPR)
5.1 IPR issues in the project lifecycle
5.1.1 Patents as a source of information
5.1.2 Novelty of research
5.1.3 Patenting versus publishing
5.1.4 Increasing the innovation activity
5.1.5 Dealing with discrepancies
5.2 Prerequisites of patenting
5.2.1 Novelty
5.2.2 Inventiveness
5.3 Freedom-to-operate
5.4 Scope of patent protection
5.5 Other forms of IP and commercialization without IPR
5.6 Termination of protection and commercialization activities
6 BUSINESS MODELS, AGREEMENTS AND OTHER LEGAL VIEWPOINTS
6.1 Material transfer agreements (MTAs)
6.1.1 MTA-in6.1.2 MTA-out
6.2 Non-disclosure agreements (NDAs)
6.3 Business models6.3.1 Licensing versus sales of IPR
6.3.2 Negotiations with alternative term sheets
6.3.3 Establishing start-up companies
7 CONCLUSIONS
8 GLOSSARYReferences
09 FURTHER READING