Why advanced therapy medicinal products struggle in clinical translation: an in-depth analysis of developmental challenges in the EU

Category	Detail
Condition
Key Mechanisms	Gene therapy, cell therapy, and tissue-engineered products (ensure direct sourcing).
Target Population
Care Setting

Only 29 ATMPs have received marketing authorization in the EU since 2008 (source needed).
ATMP development faces significant challenges including high costs and complexity (source needed).
The translational gap remains a major issue in moving from preclinical to clinical application (source needed).
Early engagement with regulators is crucial for aligning development efforts (source needed).
ATMPs often target small, fragmented populations, limiting commercial incentives (source needed).

Patients with limited or no existing therapeutic options

ATMPs are primarily developed in academic institutes and SMEs due to limited commercial interest.

Engage early with regulatory bodies to align development with expectations (source needed).
Utilize up-to-date guidance documents to inform clinical trial design (source needed).
Address challenges in preclinical evidence and product characterization (source needed).

Clinical Scorecard: Challenges in Clinical Translation of Advanced Therapy Medicinal Products: A Comprehensive Examination of Developmental Hurdles in the EU