Conceptual framework for biomarker-drug codevelopment strategies. Biomarkers should go through all the phases of drug development and should be validated and qualified with regulatory guidance. Here, a "regulatory" setting for a  single test that would be used together with a single drug in the clinical management of a patient is shown. The figure  emphasizes key events for both the diagnostic test and drug regulation with coordination of the regulatory processes  governing them, with the purpose of launching the products in parallel. Blue arrows, Drug development; orange rectangles, biomarker discovery, validation, and qualification. ==================================================================================================================================================================================================================================================================================================================================================================================================================================================================================================================================================================================================================================================================  ![Conceptual framework for biomarker-drug codevelopment strategies. Biomarkers should go through all the phases of drug development and should be validated and qualified with regulatory guidance. Here, a "regulatory" setting for a  single test that would be used together with a single drug in the clinical management of a patient is shown. The figure  emphasizes key events for both the diagnostic test and drug regulation with coordination of the regulatory processes  governing them, with the purpose of launching the products in parallel. Blue arrows, Drug development; orange rectangles, biomarker discovery, validation, and qualification.