| The role of the Istituto Superiore di Sanità as the competent authority for Phase I trials in the translation of advanced therapies. | |
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MedLine Citation:
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PMID: 21430344 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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Advanced therapy medicinal products (ATMP) can offer new, effective therapeutic options for the treatment of severe illnesses, including cancer, neurodegenerative and cardiovascular diseases. Translation of advanced therapies to the clinic has been slow despite significant academic research from academia and foundations. The implementation of 2001/20 Directive in Italy established that the development of an ATMP should follow the GXP rules - good manufacturing practice (GMP) for production, good laboratory practice (GLP) for non clinical safety studies and good clinical practice (GCP) for clinical trials. The high costs of GCP application and the needs for GMP facilities are perceived as the most important bottlenecks for the development of ATMP. Here it is pointed out that a strategic cooperation between different actors (academia, industry and experts in regulatory issues) is strongly needed. In particular, it is highlighted that the Istituto Superiore di Sanità, as the competent authority for the authorization of Phase I clinical trials, has a specific responsibility in fostering the translation of safe and effective therapies for human diseases. |
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Authors:
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Patrizia Popoli; Maria Francesca Cometa; Fulvia Fabi; Annarita Meneguz |
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Publication Detail:
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Type: JOURNAL ARTICLE |
Journal Detail:
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Title: Annali dell'Istituto superiore di sanita Volume: 47 ISSN: 0021-2571 ISO Abbreviation: - Publication Date: 2011 |
Date Detail:
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Created Date: 2011-3-24 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 7502520 Medline TA: Ann Ist Super Sanita Country: - |
Other Details:
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Languages: ENG Pagination: 79-82 Citation Subset: - |
Affiliation:
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Secretariat of the Commitee for the Evaluation of Phase I Clinical Trials, Dipartimento del Farmaco, Istituto Superiore di Sanità, Rome, Italy. E-mail: patrizia.popoli@iss.it. |
Vernacular Title:
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Il ruolo dell'Istituto Superiore di Sanità, come autorità competente per le sperimentazioni cliniche di fase 1, nella traslazione di terapie avanzate. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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