{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T13:10:24Z","timestamp":1789996224251,"version":"4.0.1"},"reference-count":28,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2026,9,5]],"date-time":"2026-09-05T00:00:00Z","timestamp":1788566400000},"content-version":"vor","delay-in-days":4,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T00:00:00Z","timestamp":1788220800000},"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":[[2026,9]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>Despite integration of artificial intelligence (AI) into drug discovery and an expanding global medicines pipeline, new drug approvals have declined, highlighting a paradox in biopharma: More drugs discovered, but less approvals, higher costs, and longer timelines. Reasons for the decreased research and development (R&amp;D) efficiency are multifactorial, in part driven by the complexity of new modalities, difficult targets and indications, and persistence of cognitive biases in clinical decision\u2010making. One proposed solution to address R&amp;D productivity challenges includes the adoption of organization\u2010wide quantitative decision frameworks (QDFs). QDFs have the potential to increase R&amp;D productivity by integrating quantitative assessments of program risk and value, clinical development costs, time, and probability of success into product valuations. A QDF integrates emerging clinical characteristics of the product through model\u2010predicted efficacy and safety and links them to common valuation models to quantify the impact of product risk and uncertainty on value at different development stages. Context\u2010aware AI can dynamically incorporate relevant unstructured information including clinical, competitor, market, and regulatory data into a QDF. The framework may be applied to compare clinical development scenarios for a single program, evaluate trade\u2010offs between programs, and support portfolio\u2010level decision making. Application of comprehensive QDFs in drug development promotes organizational alignment and transparency in product valuations, thereby supporting rationale decision\u2010making, investment partnership negotiations, and product reimbursement assessment.<\/jats:p>","DOI":"10.1111\/cts.70721","type":"journal-article","created":{"date-parts":[[2026,9,5]],"date-time":"2026-09-05T07:01:23Z","timestamp":1788591683000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Expanding Quantitative Medicines' Reach: Systems and Methods to Enhance R&amp;D Productivity and Decision\u2010Making in the Agentic\u2010Era"],"prefix":"10.1111","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0009-0007-0166-7076","authenticated-orcid":false,"given":"Brian W.","family":"Corrigan","sequence":"first","affiliation":[{"name":"Strategic Advisory Solutions Metrum Research Group  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric","family":"Anderson","sequence":"additional","affiliation":[{"name":"Strategic Advisory Solutions Metrum Research Group  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1254-3339","authenticated-orcid":false,"given":"Andrew","family":"Tredennick","sequence":"additional","affiliation":[{"name":"Strategic Advisory Solutions Metrum Research Group  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0429-542X","authenticated-orcid":false,"given":"Luis","family":"Martinez Lomeli","sequence":"additional","affiliation":[{"name":"Strategic Advisory Solutions Metrum Research Group  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Megan Cala","family":"Pane","sequence":"additional","affiliation":[{"name":"Strategic Advisory Solutions Metrum Research Group  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tyler","family":"Dunlap","sequence":"additional","affiliation":[{"name":"Strategic Advisory Solutions Metrum Research Group  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian","family":"Davis","sequence":"additional","affiliation":[{"name":"Strategic Advisory Solutions Metrum Research Group  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Rogers","sequence":"additional","affiliation":[{"name":"Strategic Advisory Solutions Metrum Research Group  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marc R.","family":"Gastonguay","sequence":"additional","affiliation":[{"name":"Strategic Advisory Solutions Metrum Research Group  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,5]]},"reference":[{"key":"e_1_2_7_2_1","unstructured":"Citeline \u201cCiteline Pharma R&D 2025 Review \u201d(2025) https:\/\/www.citeline.com\/\u2010\/media\/C28F0B5022334A4EAC9B0DDDE55F5737."},{"key":"e_1_2_7_3_1","unstructured":"U.S. Food and Drug Administration \u201cNovel Drug Approvals for 2025 \u201d(2026) https:\/\/www.fda.gov\/drugs\/novel\u2010drug\u2010approvals\u2010fda\/novel\u2010drug\u2010approvals\u20102025."},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.drudis.2025.104291"},{"key":"e_1_2_7_5_1","unstructured":"Norstella \u201cWhy are Clinical Development Success Rates Falling? \u201d(2024) https:\/\/www.norstella.com\/insight\/why\u2010are\u2010clinical\u2010development\u2010success\u2010rates\u2010falling\/."},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-024-53211-z"},{"key":"e_1_2_7_7_1","unstructured":"Deloitte \u201cBe Brave Be Bold: Measuring the Return From Pharmaceutical Innovation \u201d(2025) https:\/\/www.deloitte.com\/content\/dam\/assets\u2010zone2\/ch\/en\/docs\/industries\/life\u2010sciences\u2010health\u2010care\/2025\/ch\u2010deloitte\u2010report\u2010pharmastudy\u2010roi\u2010r\u2010d\u2010en.pdf."},{"key":"e_1_2_7_8_1","unstructured":"K.Mullin \u201cWhy are Alinical Development Success Rates Falling? \u201d(2024) https:\/\/www.norstella.com\/why\u2010clinical\u2010development\u2010success\u2010rates\u2010falling\/#:~:text=The%20main%20cause%20of%20attrition one%2Din%2Dtwo%20rate."},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1017\/CBO9780511809477"},{"key":"e_1_2_7_10_1","unstructured":"David.Shaywitz.\u201cAre We the Problem? The Role of Poor Decison Making in Stifling Drug Development \u201d(2013) Forbes."},{"key":"e_1_2_7_11_1","unstructured":"Deloitte \u201cUnleash AIs Potential: Measuring the Retrun from Pharmaceutical Innovation \u201014th Editon \u201d(2024) https:\/\/www2.deloitte.com\/content\/dam\/Deloitte\/us\/Documents\/life\u2010sciences\u2010health\u2010care\/us\u2010rd\u2010roi\u201014th\u2010edition.pdfhttp:\/\/paperpile.com\/b\/sMcUlN\/2TG6U."},{"key":"e_1_2_7_12_1","unstructured":"\u201cDrug Launches Reflect Overall Company Performance \u201d(2023) https:\/\/www.deloitte.com\/us\/en\/insights\/industry\/health\u2010care\/key\u2010factors\u2010for\u2010successful\u2010drug\u2010launch.html."},{"key":"e_1_2_7_13_1","unstructured":"T. J.Henderson \u201cGene Therapy Failures: Hard Lessons in the Code \u201d(2025) https:\/\/www.drugdiscoverynews.com\/gene\u2010therapy\u2010failures\u2010hard\u2010lessons\u2010in\u2010the\u2010code\u201016847."},{"key":"e_1_2_7_14_1","unstructured":"R. M.Peter \u201cAAV gene therapy: Pharma giants pull back on research \u201d(2025) https:\/\/www.labiotech.eu\/trends\u2010news\/aav\u2010gene\u2010therapy\u2010pharma\u2010pullback\/."},{"key":"e_1_2_7_15_1","unstructured":"\u201cNew EU Rules for Health Technology Assessments Become Effective. European Medicines Agency (ema) \u201d(2025) https:\/\/www.ema.europa.eu\/en\/news\/new\u2010eu\u2010rules\u2010health\u2010technology\u2010assessments\u2010become\u2010effective."},{"key":"e_1_2_7_16_1","unstructured":"\u201cYou Have Chosen Poorly: Why Drug Developers Make Bad Decisions \u201d(2022) https:\/\/www.aei.org\/op\u2010eds\/you\u2010have\u2010chosen\u2010poorly\u2010why\u2010drug\u2010developers\u2010make\u2010bad\u2010decisions\u2010will\u2010technology\u2010help\/http:\/\/paperpile.com\/b\/sMcUlN\/8G4n3."},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/9781119176657"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.drudis.2023.103734"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12916-020-01582-1"},{"key":"e_1_2_7_20_1","unstructured":"B.Kirby \u201cTarget Product Profile (Tpp) Playbook \u201d(2023) https:\/\/www.1daysooner.org\/wp\u2010content\/uploads\/2023\/10\/TPPPlaybookApril2023.pdf."},{"key":"e_1_2_7_21_1","unstructured":"A.ChandraandS.Mazumdar \u201cBiotech Asset Evaluation Methods: A Practioner's Guide \u201d(2024) https:\/\/www.analysisgroup.com\/globalassets\/insights\/publishing\/2024\u2010biotech\u2010asset\u2010valuation\u2010methods.pdfhttp:\/\/paperpile.com\/b\/sMcUlN\/8bUSI."},{"key":"e_1_2_7_22_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.2051"},{"key":"e_1_2_7_23_1","unstructured":"\u201cClinical Development Success Rates and Contributing Factors 2011\u20132020 \u201d(2021) https:\/\/go.bio.org\/rs\/490\u2010EHZ\u2010999\/images\/ClinicalDevelopmentSuccessRates2011_2020.pdf."},{"key":"e_1_2_7_24_1","doi-asserted-by":"publisher","DOI":"10.1002\/pst.2179"},{"issue":"1","key":"e_1_2_7_25_1","first-page":"213","article-title":"Applications of Portfolio Theory to Accelerating Biomedical Innovation","volume":"51","author":"Kumar N.","year":"2024","journal-title":"Journal of Portfolio Management"},{"key":"e_1_2_7_26_1","doi-asserted-by":"publisher","DOI":"10.1111\/cts.70188"},{"key":"e_1_2_7_27_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41586-025-09442-9"},{"key":"e_1_2_7_28_1","unstructured":"\u201cVirtual\u2010Lab: A Virtual Lab of LLM Agents for Science Research \u201d(2024) (Github)."},{"key":"e_1_2_7_29_1","unstructured":"A. G.Jaya Gupta \u201cAI's Trillion\u2010Dollar Opportunity: Context Graphs \u201d(2025) https:\/\/foundationcapital.com\/context\u2010graphs\u2010ais\u2010trillion\u2010dollar\u2010opportunity\/."}],"container-title":["Clinical and Translational Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cts.70721","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/cts.70721","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cts.70721","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T12:44:53Z","timestamp":1789994693000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/10.1111\/cts.70721"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9]]},"references-count":28,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2026,9]]}},"alternative-id":["10.1111\/cts.70721"],"URL":"https:\/\/doi.org\/10.1111\/cts.70721","archive":["Portico"],"relation":{},"ISSN":["1752-8054","1752-8062"],"issn-type":[{"value":"1752-8054","type":"print"},{"value":"1752-8062","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9]]},"assertion":[{"value":"2026-02-08","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-08-17","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-09-05","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70721"}}