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May 25, 2026Journal of Translational MedicineOpen Access

Why promising ATMPs fail to reach patients: a qualitative stakeholder-informed analysis of cell therapy access in Europe

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Authors

GMGiuseppe Di MauroItalian Society of PhysiotherapyMPMaria PachettiInternational Centre for Genetic Engineering and BiotechnologyCPChristian PlonerInnsbruck Medical University

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Implication

Qualitative analysis identifies barriers to clinical translation and access of cell therapies in Europe, suggesting necessary policy revisions.

Key Points

  • This study aims to identify barriers to the clinical translation and patient access of advanced therapy medicinal products in Europe.
  • Conducted qualitative interviews with six stakeholders in the European ATMP landscape.
  • Analyzed input from structured questionnaires and interviews to identify cross-cutting themes.
  • Examined issues related to health technology assessment, manufacturing, and regulatory frameworks.
  • HTA approaches favor short-term budget impact over long-term therapeutic benefits, affecting access decisions.
  • Variability in manufacturing settings and underinvestment in GMP infrastructure hinder therapeutic scalability.
  • Recommendations include revising HTA frameworks and enhancing cross-border regulatory cooperation.

Cite This Study

Mauro et al. (2026) studied this question.

synapsesocial.com/papers/6a13e7cf0e02ee3982d327dbhttps://doi.org/10.1186/s12967-026-08303-x
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Propelling Healthcare with Advanced Therapy Medicinal Products: A Policy Discussion2020 · 23 citations
  2. 2ATMP development and market access in Europe and the United States: why scientific innovation alone no longer wins2026
  3. 3Expanding Patient Access to Advanced Therapies2026
  4. 4Why advanced therapy medicinal products struggle in clinical translation: an in-depth analysis of developmental challenges in the EU2026 · 1 citations
  5. 5Current practices, organizational structures, technologies and challenges in developing atmps: A survey by dare-NL, nxtgen hightech, T2EVOLVE and ctiwp of EBMT - a gocart-coalition initiative2025