{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:13:29Z","timestamp":1785543209774,"version":"3.56.0"},"reference-count":3,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2025,8,19]],"date-time":"2025-08-19T00:00:00Z","timestamp":1755561600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"},{"start":{"date-parts":[[2025,8,19]],"date-time":"2025-08-19T00:00:00Z","timestamp":1755561600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Ther Innov Regul Sci"],"published-print":{"date-parts":[[2026,1]]},"DOI":"10.1007\/s43441-025-00857-0","type":"journal-article","created":{"date-parts":[[2025,8,19]],"date-time":"2025-08-19T17:44:01Z","timestamp":1755625441000},"page":"31-33","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Master Protocols: A Promising Approach to Accelerate Drug Development in Rare Kidney Diseases"],"prefix":"10.1007","volume":"60","author":[{"ORCID":"https:\/\/orcid.org\/0009-0003-3626-0971","authenticated-orcid":false,"given":"Julie","family":"Lin","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3157-5141","authenticated-orcid":false,"given":"Jai","family":"Radhakrishnan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,8,19]]},"reference":[{"issue":"6","key":"857_CR1","doi-asserted-by":"publisher","first-page":"e2415445","DOI":"10.1001\/jamanetworkopen.2024.15445","volume":"7","author":"A Sertkaya","year":"2024","unstructured":"Sertkaya A, Beleche T, Jessup A, et al. Costs of drug development and research and development intensity in the US, 2000\u20132018. JAMA Netw Open. 2024;7(6):e2415445. https:\/\/doi.org\/10.1001\/jamanetworkopen.2024.15445","journal-title":"JAMA Netw Open"},{"key":"857_CR2","doi-asserted-by":"publisher","first-page":"62","DOI":"10.1056\/NEJMra1510062","volume":"377","author":"J Woodcock","year":"2017","unstructured":"Woodcock J, LaVange L. Master protocols to study multiple therapies, multiple diseases, or both. N Engl J Med. 2017;377:62\u201370. https:\/\/doi.org\/10.1056\/NEJMra1510062","journal-title":"N Engl J Med"},{"key":"857_CR3","unstructured":".S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER). Drug and biological product development: guidance for industry. U. Center for biologics evaluation and research (CBER). Master Protocols for Drug and Biological Product Development; 2023;1\u201325. (fda.gov). Master Protocols for."}],"container-title":["Therapeutic Innovation & Regulatory Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s43441-025-00857-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s43441-025-00857-0","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s43441-025-00857-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,31]],"date-time":"2025-12-31T03:01:46Z","timestamp":1767150106000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s43441-025-00857-0"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,8,19]]},"references-count":3,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2026,1]]}},"alternative-id":["857"],"URL":"https:\/\/doi.org\/10.1007\/s43441-025-00857-0","relation":{},"ISSN":["2168-4790","2168-4804"],"issn-type":[{"value":"2168-4790","type":"print"},{"value":"2168-4804","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,8,19]]},"assertion":[{"value":"24 January 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"1 August 2025","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"19 August 2025","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"JR is an employee of Columbia University. He receives grants from Vertex and has received grants from Travere and Mineralys as well as participated on speaker bureaus for Amgen and Glaxo Smith Kline. He is also an advisor or consultant to ANI Pharmaceuticals, Inc, Aurinia Pharmaceuticals Inc., Angion Biomedica Corp, Equillium, GlaxoSmithKline, Mallinckrodt, Beigene, Novartis, Vera Therapeutics, Sanofi, and Travere. At the time of this manuscript submission, JL was an employee of Sanofi and held stocks and\/or stock options in the company. At the time of manuscript acceptance, JL is an employee of Travere Therapeutics and holds stocks and\/or stock options in the company.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing Interests"}}]}}