Pier Mannuccio Mannucci, Scientific Director of the

Policlinico Foundation, describes some of the challenges the scientific community currently faces in Italy and what actions need to be taken to overcome these. He goes on to discuss the main objectives of the foundation and how the recent restructuring will provide better quality of care to patients.

Dr. Mannucci, can you please give us a brief assessment of the Italian pharmaceutical market?

Together with fashion and manufacturing, the pharmaceutical industry is one of the main propellants of the Italian economy. While I am very proud that this is the case, I struggle to understand this dynamic, as there are many obstacles and hurdles for the healthcare and life sciences industry in the country. For example, the approval process of a drug in Italy is very lengthy. After the EMA has approved a drug, it may take another year or even more, until it is introduced in Italy.

Another feature that is typical of the Italian market is the low penetration of generic drugs. In this regard, we are lagging behind many European countries, such as the Netherlands or Germany. This is due to reluctance, both on the physicians’ side to prescribe generic drugs as well as the patients’ side to switch to or use generic drugs. In addition, the producers of generics are not very active in promoting their products, compared to the producers of branded products.

Assessing the overall development of the market, a lot has changed over the last 30 years. In general, the market used to be very lavish. Today, we are in a much more regulated and reasonable environment.

It is clear that the Policlinico Foundation has built up a solid eco-system for scientific research and its translation into therapies. Looking at the wider country, however, how would you rate Italy’s eco-system for conduction of research?

Overall, Italians are good scientists and very active in clinical studies. However, the Italian eco-system poses a number of challenges, such as long approval processes and a lot of bureaucracy, which are stopping many pharmaceutical companies and CROs coming to Italy for important Phase I and Phase II studies.

In addition, AIFA used to promote and provide grants to conduct independent clinical research on drugs. This has changed however and the availability of grants has become unpredictable or absent.

We have excellent clinical scientists but their potential is not exploited in full. We hope that Mario Melazzini, the new AIFA president, will improve this situation, promote new research projects and fund independent drug research.

The IRCCS (Institute for Treatment and Research) Ca’ Granda Ospedale Maggiore Policlinico Foundation was officially founded in 1984, from the transformation of the Ospedale Maggiore Policlinico (in turn founded as early as in 1456) with the Ministry of Health, Regione Lombardia, the Municipality and Archdiocese of Milan as its founders. Could you outline the institute’s primary aims and ambitions?

The goal of the foundation is to improve the care of the patients through research. IRCCS is a network that consists of 50 Italian hospitals – one of which is Ca’ Granda Ospedale Maggiore Policlinico. Overall, we rank second in terms of scientific production and first in terms of number of publications. We are active in multiple medical and surgical disciplines and in biomedical research, particularly clinical and translational, as well as we engage in teaching activities in collaboration the University of Milan.

Could you please elaborate on your cooperation with the University and describe some of the opportunities that emanate from this collaboration?

Indeed, the Università degli Studi of Milan also operates within the Foundation, thanks to a specific convention that was established as early as in the 1920s. One of the reasons the Policlinico Foundation is so powerful in terms of research arises from this convention. I am very optimistic about the scientific talent that develops from this collaboration.

Nevertheless, we see a lot of talent leaving Italy – partly due to the lack of focus the government puts on research, as it does not yield in immediate results. The lack of investment into scientists and research only accelerates this issue.

Do you also collaborate with the pharmaceutical industry in clinical trials or research activities?

We do collaborate with many pharmaceutical companies: for example Pfizer is supporting an initiative on polypharmacy, helping to avoid adverse drug reactions in the elderly. We also have a partnership with Baxalta in the area of hemophilia and Kedrion in plasma-derived products. We also work with Alexion who is trying to expand the use of their life saving drug Soliris. These are only examples of a much wider collaboration.

For some years now the area in Francesco Sforza, via Commenda e via Pace has been undergoing radical changes: the building of the Padiglione Monteggia in 2009, hosting the Neurosciences Department; the in-depth restructuring of the Emergency Department in 2014; and the building of the new hospital. Can you outline the rationale behind these changes and the vision of the hospital going forward?

The new Policlinico is a modern structure that will help our doctors to provide the highest level of services and care for the patients. The new structure will be deeply integrated, hosting a new surgical and medical department plus obstetrics, gynecology and pediatrics. We expect the new hospital to be ready in approximately five-six years.

As scientific director of the Policlinico Foundation, my personal ambition is to finish the new hospital and to be able to provide better services and care to our patients.

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