Definition of biomarkers and efficacy end-points
4. 'Take-home' messages
- Biomarkers are used more and more to streamline medicines development, and help tailor treatments for individual patients.
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.