# Defining core competencies for advanced therapy medicinal products translation

## TL;DR

This paper identifies key skills needed to translate advanced therapies from research to clinical use, helping to train a specialized workforce.

## Contribution

The study systematically defines and validates core competencies for ATMPs translation through expert consensus.

## Key findings

- 16 competencies reached ≥75% consensus as Fundamental for ATMPs translation.
- Key areas include regulatory strategy, manufacturing scalability, and cross-disciplinary collaboration.
- The findings can guide targeted training programs for ATMPs translational professionals.

## Abstract

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.

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.

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.

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.