> AIFA, ISS, Assobiotec. Agreement for research più fast

This is the goal of an agreement signed yesterday in Rome by the Italian drug Agency (Aifa), by the Istituto superiore di sanità (Iss) and the national Association for the development of biotechnology (Assobiotec), on the occasion of the meeting of the same association.

“With this agreement – said Roberto Gradnik, president of Assobiotec – we intend to take concrete action to strengthen the capacity of our Country to attract valuable resources, those that arise from the choice of the biopharmaceutical enterprises of locating it on our territory, the investments to carry out early phase clinical trials. In fact, we have a huge potential: Italy has in a few years has led to the development of well 136 products, and there are 132 in the preclinical phase that in the coming months will have to get to human testing, and we want to do in our Country.”

“The agreement signed today (yesterday, ndr) – he has added Guido Rasi, director general of Aifa – I think it is the beginning of a new trend of collaboration between public and private. Italy is subject to a delay compared to other european Countries due to a system structured in a way inefficient, with too many bureaucratic and planning. In più, it lacks the culture of phase I. The agreement put anà standing up a permanent table to draw together the new rules of the game, to propose new laws and to apply existing ones. To the productive sector, in the face of our commitment, we ask that you carry out in Italy in the early stages of clinical research, at least 50% of the molecules currently in preclinical phase or ‘discovery'”.

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“The clinical trial, he said Enrico Garaci, president of the Iss – is now one of the criticità of our system: this agreement may; be, therefore, an important tool for improving in that direction. Our part, like the Iss, we will support this initiative with every effort, especially for what concerns the phase I. We are in a commitment, già taken of transparency and efficiency that has led to reduce the time for assessment from 100 days in 2005 to 45 today, in the face of the fact that they have tripled the questions compared to 2005-2007, especially for the experiments of phase I from other Countries, an increase of 20%”.

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Page published on may 28, 2009