{"title":"Advancing Oncology Drug Development in the US: The Interplay between Innovations and Regulatory Science.","authors":"Yannan Nancy Dou, Jian Wang","doi":"10.1007/s43441-025-00800-3","DOIUrl":null,"url":null,"abstract":"<p><p>The landscape of drug development has evolved with the adoption of new therapeutic modalities, cutting-edge technology platforms, emerging scientific insights, and modern patient-centric clinical trial designs. In this review, we investigate the interplay between innovation and regulatory science in cancer drug development in the United States. As new innovations emerge, regulatory science adapts to integrate new discoveries and technologies, ensuring alignment with established regulations and safety standards. This fuels additional innovations through data and evidence generation, potentially expediting the development of revolutionary treatments and advancing patient access to novel, promising therapies. Early and frequent engagement with regulators is vital for drug developers aiming to successfully apply innovative approaches.</p>","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":" ","pages":""},"PeriodicalIF":2.0000,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapeutic innovation & regulatory science","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s43441-025-00800-3","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"MEDICAL INFORMATICS","Score":null,"Total":0}
引用次数: 0
Abstract
The landscape of drug development has evolved with the adoption of new therapeutic modalities, cutting-edge technology platforms, emerging scientific insights, and modern patient-centric clinical trial designs. In this review, we investigate the interplay between innovation and regulatory science in cancer drug development in the United States. As new innovations emerge, regulatory science adapts to integrate new discoveries and technologies, ensuring alignment with established regulations and safety standards. This fuels additional innovations through data and evidence generation, potentially expediting the development of revolutionary treatments and advancing patient access to novel, promising therapies. Early and frequent engagement with regulators is vital for drug developers aiming to successfully apply innovative approaches.
期刊介绍：
Therapeutic Innovation & Regulatory Science (TIRS) is the official scientific journal of DIA that strives to advance medical product discovery, development, regulation, and use through the publication of peer-reviewed original and review articles, commentaries, and letters to the editor across the spectrum of converting biomedical science into practical solutions to advance human health.
The focus areas of the journal are as follows:
Biostatistics
Clinical Trials
Product Development and Innovation
Global Perspectives
Policy
Regulatory Science
Product Safety
Special Populations
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