Improving conditions for early clinical trials
Rome – Italy’s biotech association has started an initiative to revive clinical research in Italy. At the end of May, Assobiotec’s Chairman Roberto Gradnik, head of the Italian Drug Agency Guido Rasi, and Enrico Garaci, the President of the Istituto Superiore di Sanita (ISS) signed an agreement to take action and procedures to encourage and facilitate the introduction of early (Phase I and II) clinical trials throughout the country. With the initiative, the organisations hope to attract biopharmaceutical firms to Italy to conduct trials up to clinical proof of concept.
The Italian sector currently has 136 products in the clinical pipeline and 132 under preclinical development. Biotech stakeholders now want to reduce approval times, strengthen inspection of production sites, and provide training for preparing the dossiers of clinical trial applications to attract more biotechs from abroad.
There have already been some signs of success. Since 2007, applications for Phase I studies have tripled, mainly due to reduction of the approval period from 100 to 45 days. Last year alome, Assobiotec counted 20% more biotechs from abroad that conducted their studies at Italian sites.