More National Support is Needed


They way of the emerging biotechnology sector in Italy will be not easy. There is a lot of homework still to be done to achieve the funding basis of other European countries. Both, government and venture capitalists seem to ignore the high market potential of innovative R&D. The Italian Biotechnology Association (ASSOBIOTEC) works against this fact promoting the emerging companies and giving support at national and international level. EuropeanBiotechnologyNews has had the opportunity to talk with ASSOBIOTEC's Director Leonardo Vingiani about how he sees the development of the Italian biotech sector in the European context.

Which particularities and highlights has the Italian biotech sector in comparison with other European countries?
The Italian model is primarily made up of businesses focussing on medical applications (the so-called red biotechs), thus confirming and even emphasizing the global trend. Indeed, healthcare is the field that attracts by far the majority of resources in terms of investments in research and development, and which so far has yielded the most important innovative biotech-derived products (therapeutics, vaccines and diagnostics). When comparing the Italian biotech industry with that of other European countries, where the sector is more mature and the number of companies far greater, a positive peculiarity of Italian companies can be noticed, both in terms of financial solidity and actual strength in product development. In Italy there is a particular lack of seed funds and venture capital availability for the setup of a company. Consequently, existing companies are founded on real scientific and entrepreneurial strenght. The lack of resources favours selection, and selection favours real strength. Italian companies have a very good score in terms of new products in the development pipeline - whether as drug developers or as platform technologies and service providers. When looking at Italy's position in European rankings for products at advanced stages of development, we find it climbing up to the sixth place. It is 11th as regards the number of companies, and 9th if considering only EU countries. There are 16 new drugs, 6 of which have obtained orphan drug status from the EMEA - one of these also received OD status from the FDA. Hence, Italy's performance in the biotech-derived drug development pipeline is quite remarkable, especially when compared with the overall size of its red biotech industry. This clearly shows that the existing bioindustry core has not just a great potential to help create new and effective drugs, but also in terms of products developed it is already well-placed in the leading positions as to the present and current competitiveness.
Moreover, there is a strong concentration of a dedicated biotech industry in a specific area. The region of Lombardia, particularly the area of Milan is, indeed the area with by far the highest number of biotech companies: with around 50% of the whole Italian bioindustry as well as the highest growth rate. In this area the existing companies tend to grow more rapidly in size than elsewhere. The average num-ber of employees is 50% higher than the national average. This concentration of activity allows the creation of a common thread between various different realities. It allows to build up a fruitful scientific and entrepreneurial network and sufficiently reputable and stable activity in order to attract private investment in the most promising new biotech companies.
How could the Italian biotech sector benefit from the European biotechnology?
Europe has already understood the importance of biotechnology, recognizing it as one of the main levers for social and economic growth. Other Member States are implementing specific plans to support the biotech industry. Particularly the UK, Germany and France have anticipated the European Commission's strategy for the development of biotechnology. Their govern-ments are providing specific funding schemes for the creation and development of biotechnology companies. These invest-ments have already brought significant benefits for the development of businesses, prosperity, employment, new products and services. Italy should now be stimu-lated by this “internal competition” among EU Member States in order to bridge the gap as to the size of its commitment in the field. Our country now finds itself in a position not only of certain (and due) possibility of recovery, but paradoxically, of a distinction in the huge potential of the creation of biotechnology business. It is an area that still needs to be exploited as much as it has been done by other European states of comparable size and economic relevance. But, in order to determine favourable con-ditions for the development of innovative biotechnology companies, the substantial indifference shown so far by our public policy must be replaced by an unambigu-ous positive attitude. If Italy wishes to avoid being ruled out from enjoying the benefits of the product innovation race - in primis in the medical field - it has to recognise that the creation of a supportive framework ensuring the development and growth of biotechnology companies is a strategic priority. Furthermore, the national bio-industry must be fully integrated in the European industrial and research space, through a wide-lens policy of specific industrial promotional initiatives allowing to attract potential investors. Expertise and vocation are not lacking, but a lot needs to be done in order to reach the critical mass necessary for the competitive role that Italy should play in the international arena.
How does Assobiotec support the Italian biotechnology sector?
Assobiotec's mission is to be the landmark for Italian companies involved in R&D, production and marketing of products and services derived from biotech applications. It protects their interests and promotes biotechnology as a whole, and represents the Italian bioindustry at national and international level through close interactions with the institutions and with trade and scientific organisations. Assobiotec focuses its attention particularly on the active collaboration with both national and EU institutions aiming at promoting fiscal and financial policies fostering innovation, promoting R&D programmes of strategic interest to the bioindustry, and defining a clear regulatory framework for biotech-related activities (R&D, manufacturing, marketing and use of products, intellectual property). Moreover, Assobiotec's activities include promoting the access of Italian companies to the EU funding of biotech R&D activities through the RTD Framework Programmes, and enhancing the collaboration between companies (particularly SMEs) and research organisations in the field of biotech innovation.
What kind of governmental or private support can would-be entrepreneurs get for a start-up in Italy?
In fact, there is no specific public support or private seed money for the creation of start-ups. However, some interest is rising in the financial community, although only for already existing and particularly promising companies. On the other hand, some positive elements are the recent new promotional attitude of universities towards the active support of academic spin-offs, and the interest shown by the industrial community in the most developed area (Lombardia) by offering funding for the valorisation of selected results of public research through a project called “Bioiniziativa”.
How is the public understanding of the biotech innovations in the field of human health, food and agriculture?
The general public attitude is very positive towards medical applications and quite negative about agro-food. In the whole, in both cases it can be said that the the expectations, both about medical “miracles” and GMO-derived threats, are based on a rather unscientific perception, reflecting the average scarce scientific culture among the general public, which is a traditional trait of our country, in spite of the excellence of its scientific community.
Where do you see the Italian biotechnology sector in 10 years?
Italy has experienced the birth of a specialised biotech sector only in the very last few years. But the sector has shown rapid and considerable growth showing clearly its remarkable potential, especially in terms of dedicated SMEs (both from start-ups and spin-offs from the pharmaceutical industry). Indeed, the Italian biotech industry is still very 'young', and it has grown despite the lack of specific support measures: therefore, it really has a great potential for a strong increase in growth rate, creating innovation and knowledge and thereby providing significant socio-economic benefits to the country.
By the way, there must be a substantial change in the general attitude of the national institutions, which have to understand the potential of the biotech industry in terms of general competitiveness and provide an adequate context for its growth. The present national political climate with regard to biotechnology (particularly as to understanding the importance of biotech research for the progress of healthcare) has brought about some positive signals of interest, but so far these have been limited to sporadic measures - albeit of great symbolic value, though of little definite or concrete importance - mainly focused on the biotech-derived drugs already on the market. Nothing has been done so far to pro-actively support the creation of a national strength in the field by helping and promoting specifically the innovation produced by dedicated companies: instead, there was even the freezing of the very few structural schemes available (such as the Fondo per l'Innovazione Tecnologica).
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