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DRIVE EUROPEAN ACTIVITIES FOR
ADVANCED THERAPY MEDICINAL PRODUCT
DEVELOPMENT AND IMPLEMENTATION

The JOIN4ATMP project aims to accelerate and de-risk European ATMP development and ensure wide-spread access of ATMPs, through the mapping of obstacles to such development, the audit of real-world-based solutions and the definition of new paths forward.

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PUBLICATIONS

2026

  • Designs of the clinical trials aiming at evaluating cell and gene therapy products: A critical appraisal from a literature review
    Author(s): Lucie Biard, Vincent Lévy, Sylvie Chevret - on behalf of the JOIN4ATMP consortium
    doi: https://doi.org/10.1016/j.omta.2025.201651

    This is a systematic literature review of ATMP trials from 2022 to 2024 examining the methodological and statistical aspects of current practice in clinical evaluation of ATMPs and including 276 studies including both cell and gene therapies. “To our knowledge, this is the first literature review that comprehensively examined current practice in clinical evaluation of ATMPs, regardless of regulatory approvals,” the authors state.

  • Why advanced therapy medicinal products struggle in clinical translation: an in-depth analysis of developmental challenges in the EU
    Author(s): Charlotte Van Isterdael, Edurne Mugarza, Piret Fischer, et al.
    Frontiers in Medicine - Regulatory Science
    doi: https://doi.org/10.3389/fmed.2026.1839531

    Advanced Therapy Medicinal Products (ATMPs) can offer unprecedented therapeutic benefit for patients with limited treatment options. However, their clinical translation and early-stage clinical development remain highly complex, particularly for academic developers and small- and medium-sized enterprises (SMEs). This study presents a comprehensive analysis of the different types of challenges that ATMP developers face in initiating clinical trials, based on a scoping literature review, conducted according to the JBI methodology for scoping reviews and reported according to PRISMA-ScR. PubMed, Embase and Scopus were searched for peer-reviewed literature covering the last decade, focusing on publications discussing regulatory challenges for ATMP developers at the stage of clinical trial initiation.

2024