title: The role of the Istituto Superiore di Sanità as the competent authority for Phase I trials in the translation of advanced therapies.
abstract: 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.
authors: Secretariat of the Commitee for the Evaluation of Phase I Clinical Trials, Dipartimento del Farmaco, Istituto Superiore di Sanità, Rome, Italy. patrizia.popoli@iss.it
authors: Patrizia
authors: P
authors: Popoli
authors: Maria Francesca
authors: MF
authors: Cometa
authors: Fulvia
authors: F
authors: Fabi
authors: Annarita
authors: A
authors: Meneguz
mesh_terms: D000047:Academies and Institutes; D017321:Clinical Trials, Phase I as Topic / Q000331:legislation & jurisprudence*; D006801:Humans; D007558:Italy; D057170:Translational Research, Biomedical