Transitioning From Preclinical Evidence to Advanced Therapy Medicinal Product: A Spanish Experience

A systematic and ordered product development program, in compliance with current quality and regulatory standards, increases the likelihood of yielding a successful advanced therapy medicinal product (ATMP) for clinical use as safe and effective therapy. As this is a novel field, little accurate inf...

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Bibliographic Details
Published in:Frontiers in cardiovascular medicine 2021-02, Vol.8, p.604434-604434
Main Authors: Gastelurrutia, Paloma, Prat-Vidal, Cristina, Vives, Joaquim, Coll, Ruth, Bayes-Genis, Antoni, Gálvez-Montón, Carolina
Format: Article
Language:English
Subjects:
advanced therapy medicinal product
Cardiovascular Medicine
investigational medicinal product
investigational medicinal product dossier (IMPD)
regulatory agency
translational (regulation)
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Summary:A systematic and ordered product development program, in compliance with current quality and regulatory standards, increases the likelihood of yielding a successful advanced therapy medicinal product (ATMP) for clinical use as safe and effective therapy. As this is a novel field, little accurate information is available regarding the steps to be followed, and the information to be produced to support the development and use of an ATMP. Notably, successful clinical translation can be somewhat cumbersome for academic researchers. In this article, we have provided a summary of the available information, supported by our experience in Spain throughout the development of an ATMP for myocardial infarction, from the pre-clinical stage to phase I clinical trial approval.
ISSN:2297-055X
2297-055X
DOI:10.3389/fcvm.2021.604434