Table 1 Glossary used in this paper

Biomarker:

A characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention [5].

Surrogate endpoints:

A biomarker intended to substitute for a clinical endpoint. A surrogate endpoint is expected to predict clinical benefit (or harm, or lack of benefit) based on epidemiologic, therapeutic, pathophysiologic or other scientific evidence [5].

Condition:

Any deviation(s) from the normal structure or function of the body, as manifested by a characteristic set of signs and symptoms (typically recognized distinct disease or a syndrome) (guideline ENTR/6283/00 Rev3) [2].

Orphan Condition:

the condition as defined above that meets the criteria defined in Art.3 of Regulation (EC) No 141/2000 (guideline ENTR/6283/00 Rev3) [2].

Personalised Medicine:

A medicine targeted to individual patients, based on their genetic characteristics [6].