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4. 'Take-home' messages
- Biomarkers are used more and more to streamline medicines development, and help tailor treatments for individual patients.
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In medicines development, biomarkers are commonly used in early development studies (Phase I), proof of concept studies, and molecular profiling, and sometimes as surrogate endpoints.
- As a new method, the use of biomarkers in medicines development faces technical, regulatory and ethical challenges.
- Companion Diagnostics are tests that are validated and approved for marketing in combination with a new medicine. Since in the EU, medicines and diagnostics are regulated differently, obtaining a marketing authorisation for a medicine and its companion diagnostic together adds an extra layer of complexity to the approval process.