Italy has all the credentials to be a leading player in the sector of ATMP, but it must continue to invest in skills, resources and long-term strategies to ensure that its scientific discoveries are translated into effective therapeutic solutions by organisations in our country. The risk is that if this opportunity is not provided in our country, many organisations will be forced to seek it abroad. In this way, valuable resources will be taken away from better structured nations, as is already the case for individual researchers, the well-known brain drain.
Pioneers
The podcast “Biotech Pioneers” – produced by MakingLife in collaboration with Genenta Science – describes the long journey from the laboratory to the market, with the difficulties, strategies and solutions. Simone Montonati and Pierluigi Paracchi interview some of the main protagonists, pioneers of a sector that does not envisage marked paths or standard procedures:
- Lidia Pieri, co-founder and CEO of Sybilla Biotech, a company that develops molecules with a new mechanism of action thanks to a proprietary physics-based computational platform
- Alberto Auricchio, scientific director of TIGEM and founder and Cso of AAVantgarde, an international (but Italian-based) clinical-stage biotechnology company that has developed two exclusive adeno-associated viral vector platforms with the aim of overcoming the limitations imposed by the current DNA loading capacity of AAVs
- Paolo Rizzardi, co-founder and CEO of Altheia Science, a pioneering start-up company developing innovative therapeutic approaches in the field of autoimmune diseases and liquid tumours, whose founders include two Italian scientists of global importance, Alessandra Biffi and Paolo Fiorina
- Maria Luisa Nolli, co-founder and CEO of NCNbio, a company specialising in industrial technology transfer in the field of biotechnology
- Giuseppe Speziale, consultant at Deloitte Legal and legal expert in the biotechnology sector and Marco Perrone, partner at Officine Innovazione
- Marco Ferrari, CEO of Anemocyte, a Bmo (biotech manufacturing organisation) focused on the development and production of plasmids for the production of viral vectors and mRNA.
The long march
In the field of ATMPs, even the most promising scientific solutions face extremely complex challenges to reach the market: an intricate maze of ever-changing regulations, a highly competitive market, extremely high development costs and, of course, the need to find adequate expertise and funding to reach the market. And even once this tortuous journey is complete, long-term economic sustainability is threatened by exceptional production costs and, in the case of ultra-rare diseases, very limited patient pools.
The cost of development – and subsequently of production – is very high, and it is precisely at the most advanced stages (typically the clinical ones) that efficient capital is needed, i.e. in large quantities and with much faster disbursement times than those offered by charities and international or ministerial public calls, which currently guarantee the first steps of research.
A slowdown due to a lack of funds risks favouring more organised realities (perhaps abroad) or bringing the product to market years later (with potentially dramatic consequences for patients’ lives). Unfortunately, compared to more mature realities such as the United States, the italian financial system to support this journey is still underdeveloped, with a small number of banks, investors, analysts and consultants specialising in the biotech sector.
It is clear that this tortuous path cannot be tackled by research centres or academic institutions alone.
Academic research generally does not have within it all the skills needed to develop a drug and at a certain point the research centre, the hospital, the scientist must meet entrepreneurs, experienced business managers, product development specialists, without whom the research risks remaining a cue for a nice scientific paper but without any benefit for patients. It is a natural transition.
Pierluigi Paracchi, co-founder and Ceo of Genenta Science
The internationalisation of Italian biotech companies
This is a particularly difficult step to take in a country that, although mature, has not yet succeeded in creating a structured and efficient ecosystem to accompany researchers and entrepreneurs in a sector that is in many ways still in its infancy.
In this sense, the “Working Table for the Internationalisation of Biotechnology Industries“, set up by Minister Tajani and chaired by Pierluigi Paracchi, is an important step in this direction and represents an important element of innovation for Italy, Giovanni Caforio, CEO of Bristol-Myers Squibb, Pierluigi Petrone of Farmindustria with the group of the same name, Gianmario Verona of Human Technopole, exponents of the CNR, the top management of ENEA Biomedica Tech and, of course, representatives of Maeci and Mimit (the Ministries of Foreign Affairs and Enterprise and Made in Italy).
