{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T13:20:11Z","timestamp":1787664011860,"version":"build-2736575974"},"reference-count":32,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T00:00:00Z","timestamp":1787184000000},"content-version":"vor","delay-in-days":19,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:00:00Z","timestamp":1785542400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>The transition to value\u2010based healthcare demands more efficient, evidence\u2010driven approaches to drug discovery, development and medical use. Clinical pharmacology is uniquely positioned to support this shift through model\u2010informed drug development (MIDD) decision\u2010making, integrating quantitative methods across the product lifecycle. This commentary outlines a roadmap for embedding MIDD from early drug discovery through regulatory evaluation and ultimately into reimbursement and real\u2010world use. We highlight how pharmacokinetic\/pharmacodynamic modeling, mechanistic modeling, disease progression models, patient\u2010relevant endpoints, and real\u2010world data will inform dose selection, optimize trial design, and reduce uncertainty in benefit\u2013risk and cost\u2010effectiveness assessments. Emphasis is placed on cross\u2010stakeholder alignment, including regulators, payers, clinicians, and industry, to ensure that model\u2010informed evidence translates into demonstrable patient and economic value. Key challenges, such as data integration, model transparency, and acceptance by decision\u2010makers, are discussed alongside practical solutions. By advancing a lifecycle\u2010based, quantitatively informed framework, clinical pharmacology can play a central role in delivering therapies that are not only safe and effective but also aligned with the principles of value\u2010based healthcare.<\/jats:p>","DOI":"10.1002\/jcph.70270","type":"journal-article","created":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T11:14:08Z","timestamp":1787224448000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Model\u2010Informed Decision Making from Drug Discovery to Reimbursement: A Roadmap for Clinical Pharmacology in Value\u2010Based Healthcare"],"prefix":"10.1002","volume":"66","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3127-9732","authenticated-orcid":false,"given":"Rajesh","family":"Krishna","sequence":"first","affiliation":[{"name":"Certara Drug Development Solutions Certara USA, Inc.  Radnor PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ananth","family":"Kadambi","sequence":"additional","affiliation":[{"name":"Certara Drug Development Solutions Certara USA, Inc.  Radnor PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick","family":"Smith","sequence":"additional","affiliation":[{"name":"Certara Drug Development Solutions Certara USA, Inc.  Radnor PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Piet H.","family":"van der Graaf","sequence":"additional","affiliation":[{"name":"Certara Predictive Technologies  Certara, Sheffield UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2833-8305","authenticated-orcid":false,"given":"Fran","family":"Brown","sequence":"additional","affiliation":[{"name":"Certara Drug Development Solutions Certara USA, Inc.  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