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Frequently Asked Questions (FAQ) - SME-PHC12-2014/2015 Topic related questions

Answer: 

Yes for the PHC topic, funding rate is 100%

Answer: 

No, the feasibility assessment in phase 1 is addressing activities like risk assessment, description of bottlenecks, market study, user involvement, IP regime, partner search etc. Clinical studies are activities planned in phase 2.

Answer: 

Please use the definitions as shown here (and please see also the corresponding literature)

A biomarker is a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention (NHI Biomarkers Definitions Working Group; 2001)

A valid biomarker is defined as “a biomarker that is measured in an analytical test system with well-established performance characteristics and for which there is an established scientific framework or body of evidence that elucidates the physiologic, toxicological, pharmacologic, or clinical significance of the test results

(FDA. Guidance for industry - pharmacogenomic data submissions. 2005)