{"title":"癌症纳米药物的转化之旅：生物学和创业经验教训。","authors":"Cristianne Johanna Ferdinand Rijcken","doi":"10.1007/s13346-025-01867-z","DOIUrl":null,"url":null,"abstract":"<p><p>Despite exhaustive investments, the breakthrough potential of nanomedicines (NM) is not yet realized. Whilst Doxil and covid-19 vaccines demonstrated certain benefits, many NM failed in clinical development. Lies the true reason for this limited success in inappropriate assumptions, incorrect approaches, or other omissions? This note describes the translational journey of CPC634 (docetaxel entrapping core-crosslinked polymeric micelles) and illustrates lessons learned in drug product development. Scientific elements are to understand the pathophysiology of the diseased tissue, the journey of NM upon administration and resulting drug release and the induced pharmacodynamic effects over time, particularly in actual patients. Industrial elements comprise market-product fit, target product profile, competitive benchmarking, while development efficiency focuses to generate a positive business case. A goal-oriented product design which is validated by external experts increases chances of development success and assures investor-readiness. NM development will progress by aligning fundamental biological insights with industrial product requirements, driving therapeutic breakthroughs.</p>","PeriodicalId":11357,"journal":{"name":"Drug Delivery and Translational Research","volume":" ","pages":"3351-3362"},"PeriodicalIF":5.5000,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"The translational journey of cancer nanomedicines: biological and entrepreneurial lessons learned.\",\"authors\":\"Cristianne Johanna Ferdinand Rijcken\",\"doi\":\"10.1007/s13346-025-01867-z\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Despite exhaustive investments, the breakthrough potential of nanomedicines (NM) is not yet realized. Whilst Doxil and covid-19 vaccines demonstrated certain benefits, many NM failed in clinical development. Lies the true reason for this limited success in inappropriate assumptions, incorrect approaches, or other omissions? This note describes the translational journey of CPC634 (docetaxel entrapping core-crosslinked polymeric micelles) and illustrates lessons learned in drug product development. Scientific elements are to understand the pathophysiology of the diseased tissue, the journey of NM upon administration and resulting drug release and the induced pharmacodynamic effects over time, particularly in actual patients. Industrial elements comprise market-product fit, target product profile, competitive benchmarking, while development efficiency focuses to generate a positive business case. A goal-oriented product design which is validated by external experts increases chances of development success and assures investor-readiness. NM development will progress by aligning fundamental biological insights with industrial product requirements, driving therapeutic breakthroughs.</p>\",\"PeriodicalId\":11357,\"journal\":{\"name\":\"Drug Delivery and Translational Research\",\"volume\":\" \",\"pages\":\"3351-3362\"},\"PeriodicalIF\":5.5000,\"publicationDate\":\"2025-10-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Drug Delivery and Translational Research\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s13346-025-01867-z\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/4/30 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Drug Delivery and Translational Research","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s13346-025-01867-z","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/4/30 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
The translational journey of cancer nanomedicines: biological and entrepreneurial lessons learned.
Despite exhaustive investments, the breakthrough potential of nanomedicines (NM) is not yet realized. Whilst Doxil and covid-19 vaccines demonstrated certain benefits, many NM failed in clinical development. Lies the true reason for this limited success in inappropriate assumptions, incorrect approaches, or other omissions? This note describes the translational journey of CPC634 (docetaxel entrapping core-crosslinked polymeric micelles) and illustrates lessons learned in drug product development. Scientific elements are to understand the pathophysiology of the diseased tissue, the journey of NM upon administration and resulting drug release and the induced pharmacodynamic effects over time, particularly in actual patients. Industrial elements comprise market-product fit, target product profile, competitive benchmarking, while development efficiency focuses to generate a positive business case. A goal-oriented product design which is validated by external experts increases chances of development success and assures investor-readiness. NM development will progress by aligning fundamental biological insights with industrial product requirements, driving therapeutic breakthroughs.
期刊介绍：
The journal provides a unique forum for scientific publication of high-quality research that is exclusively focused on translational aspects of drug delivery. Rationally developed, effective delivery systems can potentially affect clinical outcome in different disease conditions.
Research focused on the following areas of translational drug delivery research will be considered for publication in the journal.
Designing and developing novel drug delivery systems, with a focus on their application to disease conditions;
Preclinical and clinical data related to drug delivery systems;
Drug distribution, pharmacokinetics, clearance, with drug delivery systems as compared to traditional dosing to demonstrate beneficial outcomes
Short-term and long-term biocompatibility of drug delivery systems, host response;
Biomaterials with growth factors for stem-cell differentiation in regenerative medicine and tissue engineering;
Image-guided drug therapy,
Nanomedicine;
Devices for drug delivery and drug/device combination products.
In addition to original full-length papers, communications, and reviews, the journal includes editorials, reports of future meetings, research highlights, and announcements pertaining to the activities of the Controlled Release Society.
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