Why advanced therapy medicinal products struggle in clinical translation: an in-depth analysis of developmental challenges in the EU - Summary - MDSpire
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Why advanced therapy medicinal products struggle in clinical translation: an in-depth analysis of developmental challenges in the EU
To analyze the challenges faced by Advanced Therapy Medicinal Products (ATMP) developers in initiating clinical trials, focusing on specific regulatory challenges.
Key Findings:
Challenges are identified in four areas: preclinical evidence and product characteristics, cell sourcing and manufacturing, clinical trials, and regulatory landscape.
Early engagement with regulators and access to up-to-date guidance documents are important for aligning developer efforts with regulatory expectations.
Since the regulation was introduced in 2008, only 29 ATMPs have received marketing authorization in the EU.
Interpretation:
Limitations:
The analysis primarily focuses on the European regulatory context, which may not fully represent challenges in other jurisdictions.
The review may not capture all relevant literature due to the selection criteria and search strategy employed.
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