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.