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Bringing biotechnology to Italy – an essential step for rare diseases treatments

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Dr. Albert Farrugia


The importance of the biotech industry to the growth and competitiveness of the European pharmaceutical sector is fundamental. Today, the majority of innovative medicines – as well as many diagnostic products – are developed or manufactured using biotechnology.

Globally, biotech medicines represent 20% of commercialised drugs, 40% of authorised drugs and 50% of drugs under development. These medicines are particularly needed for patients with rare diseases, where the principles of large pharma are rarely relevant.

Italy’s biotech landscape suffers from limited investment from the mainstream sectors, due to inadequate funding and challenges in the transfer of technologies. With 110 biotech drugs available for treating a range of disorders, Italy’s biotech industry nevertheless lags behind in Europe; in a Biotechnology Innovation Scorecard[1], Italy scored 28.7/100, placing it 38th of the 54 countries studied.

However, the situation is starting to change with coordinated efforts in research, finance and organisation. In recent years, the biotech industry in Italy has developed due to excellent academic and industrial research as well as the value of the technology and products developed.

  • Italian biotech companies totalled 571 in 2017
  • Italian biotech turnover is over $12.2 billion (increasing by 12% between 2014 and 2016)
  • Investments in R&D amounted to $2 billion between 2014 and 2016
  • There are about 3,790 employees in biotech research.

Biotechnology is among the sectors utilising the higher level of innovation in Italy. In particular, smaller companies are driving innovation, addressing the challenges posed by limited funding and technology transfer through building skilled scientific and commercial teams, developing intellectual property and entering into partnerships with like-minded organisations.

A network with room for improvement

Furthermore, technology transfer infrastructure in Italy is still very underdeveloped, and commercialising technologies from institutions can be a difficult process, unless adapted to the particular needs of rare disease therapies. Moreover, with few exceptions, the local biotech community is still poorly networked; scientific groups tend to work in isolation rather than integrating with the international biotech community.

Biotechnology is among the sectors utilising the higher level of innovation in Italy.

However, new events, awards and accelerator programmes, like BioInItaly, Meet in Italy for Life Sciences and Bioupper, are taking off.

Banks, venture capitalists and even the Government are also now more willing to invest in Italy’s biotech industry, due to the evidence that the innovative approach of small companies is paying off.

Supporting those who need it most

Infrastructure, funding and collaboration are persistent challenges for the biotech industry. Despite this, in the least economically advantaged parts of the country, biotech companies are focusing on the provision of therapies that are otherwise inaccessible.

“Pharma philosophy should be about creating a balance between social engagement and financial necessity. For example, it may be difficult to get medication to a patient in a particular country, but a pharmaceutical company should deliver in such a situation. Even if the cost of delivery is more than the cost of the drugs, it is the responsibility of such large organisations to ensure that the patient is taken care of,” says Dr Davide Rosiello, founder of biotech and pharmaceutical company, BioVIIIx, who specialise in bleeding disorders and rare diseases, especially haemophilia.

There has been marked commitment from one firm in Naples to haemophilia and related bleeding disorders to deliver products overlooked by the mainstream providers. Steady growth has also stimulated the formation of a new division based on the development of orphan medicines for rare diseases.

Rare disease research and development needs a strong internal core of commercial and scientific expertise committed to innovation. An ethos of openness to the establishment of relationships with a number of innovative, local biotech companies and international startups can enable the generation of strong intellectual property addressing substantial unmet medical need in the areas of oncology and medical information technology.

Dr Rosiello says: “In order to protect patients, doctors, colleagues, suppliers and stakeholders in general, it is essential to keep to a set of principles that govern every day of our lives, whatever our role in the company, and irrespective of  the mandatory requirements of the governing bodies.”

BIOVIIIx operates under the philosophy of “having a multiplicity of arrows in our quiver, in order to maximise the opportunity of hitting our target!”

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