Why advanced therapy medicinal products struggle in clinical translation: an in-depth analysis of developmental challenges in the EU - Takeaways - MDSpire

Why advanced therapy medicinal products struggle in clinical translation: an in-depth analysis of developmental challenges in the EU

  • By

  • Charlotte Van Isterdael

  • Edurne Mugarza

  • Piret Fischer

  • Koen Debackere

  • Peter Vandenberghe

  • Silvia Martin Lluesma

  • Johan Van Eldere

  • Isabelle Huys

  • June 2, 2026

  • 0 min

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  • 1

    Advanced Therapy Medicinal Products (ATMPs) offer potential benefits for patients with limited treatment options but face complex clinical translation challenges.

  • 2

    The study identifies four key challenge areas for ATMP developers: preclinical evidence, cell sourcing and manufacturing, clinical trials, and regulatory landscape.

  • 3

    Only 29 ATMPs have received marketing authorization in the EU since the regulation's introduction in 2008, highlighting limited access.

  • 4

    The clinical translation of ATMPs is more challenging than conventional pharmaceuticals due to complexity, high costs, and specialized expertise.

  • 5

    The review aims to enhance regulatory awareness among academic and SME developers by mapping frequently reported challenges in ATMP development.

Original Source(s)

Why advanced therapy medicinal products struggle in clinical translation: an in-depth analysis of developmental challenges in the EU

  • by Charlotte Van Isterdael, Edurne Mugarza, Piret Fischer, Koen Debackere, Peter Vandenberghe, Silvia Martin Lluesma, Johan Van Eldere, Isabelle Huys

  • June 2, 2026

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