dc.contributor | Vall d'Hebron Barcelona Hospital Campus |
dc.contributor.author | Vives Armengol, Joaquim |
dc.contributor.author | Coll, Ruth |
dc.contributor.author | Gálvez-Montón, Carolina |
dc.contributor.author | Prat-Vidal, Cristina |
dc.contributor.author | Gastelurrutia, Paloma |
dc.contributor.author | Bayes-Genis, Antoni |
dc.date.accessioned | 2021-07-07T12:37:38Z |
dc.date.available | 2021-07-07T12:37:38Z |
dc.date.issued | 2021-02-04 |
dc.identifier.citation | Gastelurrutia P, Prat-Vidal C, Vives J, Coll R, Bayes-Genis A, Gálvez-Montón C. Transitioning From Preclinical Evidence to Advanced Therapy Medicinal Product: A Spanish Experience. Front Cardiovasc Med. 2021 Feb 4;8:604434. |
dc.identifier.issn | 2297-055X |
dc.identifier.uri | https://hdl.handle.net/11351/6128 |
dc.description | Advanced therapy medicinal product; Investigational medicinal product; Translational (regulation) |
dc.description.abstract | 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. |
dc.language.iso | eng |
dc.publisher | Frontiers Media |
dc.relation.ispartofseries | Frontiers in Cardiovascular Medicine;8 |
dc.rights | Attribution 4.0 International |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ |
dc.source | Scientia |
dc.subject | Medicina - Investigació - Espanya |
dc.subject | Medicina basada en l'evidència |
dc.subject | Medicaments - Desenvolupament |
dc.subject.mesh | Translational Medical Research |
dc.subject.mesh | Therapies, Investigational |
dc.subject.mesh | Spain |
dc.title | Transitioning From Preclinical Evidence to Advanced Therapy Medicinal Product: A Spanish Experience |
dc.type | info:eu-repo/semantics/article |
dc.identifier.doi | 10.3389/fcvm.2021.604434 |
dc.subject.decs | investigación médica traslacional |
dc.subject.decs | tratamientos en investigación |
dc.subject.decs | España |
dc.relation.publishversion | https://www.frontiersin.org/articles/10.3389/fcvm.2021.604434/full |
dc.type.version | info:eu-repo/semantics/publishedVersion |
dc.audience | Professionals |
dc.contributor.organismes | Institut Català de la Salut |
dc.contributor.authoraffiliation | [Gastelurrutia P, Prat-Vidal C] Institut d'Investigació Biomèdica de Bellvitge-IDIBELL, L'Hospitalet de Llobregat, Spain. Insuficiencia Cardíaca y Regeneración Cardíaca Research Program, Fundació Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol (IGTP), Badalona, Spain. Centro de Investigación Biomédica en Red Cardiovascular, Instituto de Salud Carlos III, Madrid, Spain. [Vives J] Servei de Teràpia Cel·lular, Banc de Sang i Teixits, Barcelona, Spain. Grup d’Enginyeria tissular musculoesquelètica, Vall d'Hebron Institut de Recerca (VHIR), Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain. Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain. [Coll R] Servei de Teràpia Cel·lular, Banc de Sang i Teixits, Barcelona, Spain. [Bayes-Genis A] Insuficiencia Cardíaca y Regeneración Cardíaca Research Program, Fundació Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol (IGTP), Badalona, Spain. Centro de Investigación Biomédica en Red Cardiovascular, Instituto de Salud Carlos III, Madrid, Spain. Hospital Universitari Germans Trias i Pujol, Badalona, Spain. Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain. [Gálvez-Montón C] Insuficiencia Cardíaca y Regeneración Cardíaca Research Program, Fundació Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol (IGTP), Badalona, Spain. Centro de Investigación Biomédica en Red Cardiovascular, Instituto de Salud Carlos III, Madrid, Spain |
dc.identifier.pmid | 33614746 |
dc.identifier.wos | 000619000600001 |
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dc.rights.accessrights | info:eu-repo/semantics/openAccess |