Defining core competencies for advanced therapy medicinal products translation

Abstract

Background: Translating Advanced Therapy Medicinal Products (ATMPs) from research to clinical application requires a specialized set of priority topic areas that is not yet systematically defined. Methods: We employed a multi-phase approach combining a targeted literature review with a structured expert consensus survey. Selected experts evaluated a set of 35 preselected competencies across seven thematic areas using an anonymous online questionnaire, categorizing them as Fundamental, Ancillary, or Less Important for ATMPs translation. Results: Concordance was high, with 16 competencies reaching the ≥75% consensus threshold as Fundamental. These covered regulatory strategy, manufacturing scalability, quality management, clinical translation, and cross-disciplinary collaboration. Conclusions: This study establishes a validated set of ATMP-specific competencies that can serve as the basis for targeted training programs. Embedding these into education and professional development will help build a workforce capable of navigating the complex and constantly evolving translational needs of ATMPs.