{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,22]],"date-time":"2026-06-22T05:47:13Z","timestamp":1782107233712,"version":"3.54.5"},"reference-count":9,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2026,6,13]],"date-time":"2026-06-13T00:00:00Z","timestamp":1781308800000},"content-version":"vor","delay-in-days":12,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,6,1]],"date-time":"2026-06-01T00:00:00Z","timestamp":1780272000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2026,6]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>Quantitative medicine supports modern drug development and regulatory decision\u2010making by integrating non\u2010clinical and clinical data to inform dose selection, trial optimization, and extrapolation across populations and benefit\u2013risk assessment. The Medicines and Healthcare products Regulatory Agency (MHRA) has adopted quantitative approaches across the product lifecycle within a risk\u2010proportionate regulatory framework. Internationally, the ICH M15 guideline provides a harmonized framework for planning, evaluation and documentation of model\u2010informed drug development (MIDD) evidence which is aligned with MHRA practice. This perspective describes the application of quantitative medicine to UK regulatory decision\u2010making using two case studies: sugemalimab (Eqjubi) in oncology and lecanemab (Leqembi) in Alzheimer's disease. The case studies are assessed using ICH M15 concepts, including context of use, model influence, and consequence of a wrong decision. For sugemalimab, quantitative pharmacokinetic modeling supported a high\u2010impact dosing decision with clinically meaningful consequences of a wrong decision requiring proportionate scrutiny and mitigation of uncertainty. For lecanemab, multiple quantitative models with lower individual influence supported interpretation of pharmacokinetic variability, biomarkers, and clinical outcomes within the overall benefit\u2013risk assessment. These case studies demonstrate how quantitative models can support decisions with differential impact ranging from critical dosing decisions to interpretation of complex data. Regulatory policy that is aligned with ICH M15 can be used to support the use of quantitative medicine to link complex modeling approaches with regulatory decision\u2010making and enable patient access to medicines.<\/jats:p>","DOI":"10.1111\/cts.70636","type":"journal-article","created":{"date-parts":[[2026,6,13]],"date-time":"2026-06-13T14:06:25Z","timestamp":1781359585000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Quantitative Medicine to Support Drug Development and Regulatory Decisions: A\n                    <scp>UK<\/scp>\n                    Regulatory Approach Informed by\n                    <scp>ICH M15<\/scp>"],"prefix":"10.1111","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4368-8565","authenticated-orcid":false,"given":"Essam","family":"Kerwash","sequence":"first","affiliation":[{"name":"Medicines and Healthcare Products Regulatory Agency (MHRA)  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4362-940X","authenticated-orcid":false,"given":"Andrew S.","family":"Butler","sequence":"additional","affiliation":[{"name":"Medicines and Healthcare Products Regulatory Agency (MHRA)  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1144-0629","authenticated-orcid":false,"given":"Maria","family":"Malamatari","sequence":"additional","affiliation":[{"name":"Medicines and Healthcare Products Regulatory Agency (MHRA)  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4582-6231","authenticated-orcid":false,"given":"Susan","family":"Cole","sequence":"additional","affiliation":[{"name":"Medicines and Healthcare Products Regulatory Agency (MHRA)  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,6,13]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.13077"},{"key":"e_1_2_8_3_1","unstructured":"\u201cGuideline on Reporting the Results of Population Pharmacokinetics Analyses (CHMP\/EWP\/185990\/06 Committee for Medicinal Products for Human Use) \u201d(2026) https:\/\/www.ema.europa.eu\/en\/documents\/scientific\u2010guideline\/guideline\u2010reporting\u2010results\u2010population\u2010pharmacokinetic\u2010analyses_en.pdf."},{"key":"e_1_2_8_4_1","unstructured":"\u201cGuideline on the Reporting of Physiologically Based Pharmacokinetic (PBPK) Modelling and Simulation (EMA\/CHMP\/458101\/2016 Committee for Medicinal Products for Human Use (CHMP)) \u201d(2026) https:\/\/www.ema.europa.eu\/en\/documents\/scientific\u2010guideline\/guideline\u2010reporting\u2010physiologically\u2010based\u2010pharmacokinetic\u2010pbpk\u2010modelling\u2010and\u2010simulation_en.pdf."},{"key":"e_1_2_8_5_1","unstructured":"Medicines and Healthcare products Regulatory Agency (MHRA) \u201cReal\u2010World Evidence Scientific Dialogue Programme \u201d(2026) https:\/\/www.gov.uk\/government\/publications\/mhra\u2010real\u2010world\u2010evidence\u2010scientific\u2010dialogue\u2010programme\/mhra\u2010real\u2010world\u2010evidence\u2010scientific\u2010dialogue\u2010programme."},{"key":"e_1_2_8_6_1","unstructured":"International Council for Harmonisation \u201cICH Harmonised Guideline: General Principles for Model Informed Drug Development (M15) Step 5 \u201d(2026)."},{"key":"e_1_2_8_7_1","unstructured":"\u201cEqjubi (Sugemalimab) MHRA Public Assessment Report PLGB 54280\/0003 \u201d(2026) https:\/\/mhraproducts4853.blob.core.windows.net\/docs\/f78f72cf2269a47b84b7982501532ea0ca51556b."},{"key":"e_1_2_8_8_1","unstructured":"\u201cLeqembi (Lecanemab) MHRA Public Assessment Report PLGB 33967\/0027 \u201d(2026) https:\/\/mhraproducts4853.blob.core.windows.net\/docs\/6ed2db79b7202feb5a8edbecfa5c35bb434381e6."},{"key":"e_1_2_8_9_1","unstructured":"\u201cCejemly EMA Public Assessment Report (EMA\/380155\/2024 Committee for Medicinal Products for Human Use (CHMP)) \u201d(2026) https:\/\/www.ema.europa.eu\/en\/documents\/assessment\u2010report\/cejemly\u2010epar\u2010public\u2010assessment\u2010report_en.pdf."},{"key":"e_1_2_8_10_1","unstructured":"\u201cAltuvoct Public MHRA Assessment Report PLGB 30941\/0024\u20100030 \u201d(2026) https:\/\/mhraproducts4853.blob.core.windows.net\/docs\/c4e707b0b30603b9c0755e35e0dad26aa9219a10."}],"container-title":["Clinical and Translational 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