Defining core competencies for advanced therapy medicinal products translation.

Area of Science:

• Biomedical Science
• Translational Medicine
• Pharmaceutical Sciences

Background:

• Translating Advanced Therapy Medicinal Products (ATMPs) into clinical practice lacks a defined set of essential skill areas.
• A systematic approach is needed to identify critical competencies for ATMP development.

Purpose of the Study:

• To systematically define and validate priority topic areas and competencies for ATMP translation.
• To establish a foundation for targeted educational and professional development programs in ATMP translation.

Main Methods:

• A multi-phase approach combining literature review and expert consensus survey.
• Experts evaluated 35 competencies across seven thematic areas using an anonymous online questionnaire.
• Competencies were categorized as Fundamental, Ancillary, or Less Important for ATMP translation.

Main Results:

• High concordance was achieved, with 16 competencies identified as Fundamental (≥75% consensus).
• Key fundamental competencies include regulatory strategy, manufacturing scalability, quality management, clinical translation, and cross-disciplinary collaboration.
• These validated competencies provide a clear roadmap for ATMP workforce development.

Conclusions:

• This study presents a validated set of ATMP-specific competencies essential for successful research-to-clinic translation.
• These competencies can inform the design of targeted training programs and professional development initiatives.
• Building a skilled workforce is vital for navigating the complexities of ATMP development and application.