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. 2025 Apr 30.
doi: 10.1007/s13346-025-01867-z. Online ahead of print.

The translational journey of cancer nanomedicines: biological and entrepreneurial lessons learned

Cristianne Johanna Ferdinand Rijcken  1   2
Affiliations

The translational journey of cancer nanomedicines: biological and entrepreneurial lessons learned

Cristianne Johanna Ferdinand Rijcken. Drug Deliv Transl Res. .

Abstract

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.

Keywords: Cancer nanomedicines; Clinical evaluation; Entrepreneurial aspects spinoff; Fundamental biological insights; Translational development.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: Not relevant. Consent for publication: CR. Competing interests: CR is shareholder of Cristal Therapeutics and Liberates.

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