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Key barriers include timely generation of robust predictive biomarker hypotheses (i.e., hypotheses regarding treatment\u2010by\u2010biomarker interactions), appropriate validation strategies, and coordinated development of companion diagnostics within increasingly complex FDA, European Medicines Agency, and In\u00a0Vitro Diagnostic Regulation regulatory frameworks. This review presents a pragmatic operational framework to guide the incorporation of precision medicine into drug development across therapeutic areas. We outline structured approaches for early biomarker hypothesis generation and prephase II evidence development; define five clinical development scenarios based on the strength of the biomarker signal\u2014front\u2010loaded enrichment, precision\u2010medicine\u2010enabled phase II, adaptive phase II, adaptive phase III, and back\u2010loaded confirmatory enrichment; and summarize regulatory and lifecycle considerations for companion diagnostics. 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Early, structured biomarker planning; integrated clinical\u2013diagnostic strategies; and iterative collaboration among sponsors, regulators, HTA bodies, payers, and patients are critical for translating biomarker insights into de\u2010risked pivotal trials and aligned regulatory and market\u2010access decisions.<\/jats:p>","DOI":"10.1002\/cpt.70423","type":"journal-article","created":{"date-parts":[[2026,8,7]],"date-time":"2026-08-07T06:51:36Z","timestamp":1786085496000},"page":"914-929","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Operationalizing Precision Medicine in Drug Development: Predictive Biomarkers, Companion Diagnostics, and Regulatory Pathways"],"prefix":"10.1002","volume":"120","author":[{"ORCID":"https:\/\/orcid.org\/0009-0007-8145-0546","authenticated-orcid":false,"given":"Ingrid","family":"Holst\u2010Laubjerg","sequence":"first","affiliation":[{"name":"Department of Drug Design and 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