Tiziana Azzani

Pharma World Magazine begins a journey of discovery of the main actors of Technology Transfer in Italy interviewing Maria Luisa Nolli, CEO NCNbio

Innovation is the way to growth in a modern economic system, while research and development are the engine that ensures the continuity and sustainability. Because of biotechnological transformation, these activities have gradually become more complex compared to the past characterized by chemically synthetic drugs; now the research phase remains in University which has the knowledge and scientific expertise, while the development phase of a new drug, medical device or diagnostic device remains in the Biotech Company, which has the facilities and expertise to bring the product to market.

Who then owns the innovative product? Who protects the intellectual property and especially how patients can be ensured to receive all benefits coming from the evolution of biomedical science? The innovative process has to be aligned with regulation processes of market and with those of assessment which mark the technology access in practice. They have also to consider the appropriateness and economic sustainability of health systems. The creation of a closer relationship between the research world, institutions and the business system, the so-called “triple helix”, is the determining factor for the development of innovative capacity particularly in knowledge-intensive sectors. In other words, technological innovation has to be promptly transferred into clinical practice through specialized structures dealing in Technology Transfer, such as a “missing link” between University and Company. It is a new model that has been spreading rapidly, especially abroad and overseas. As Brady Huggett wrote in an article published by Nature Biotechnology, in the last few years in American Universities have been implementing a radical change characterized by of investment of large amounts of capital to expand and structure spaces devoted to technology transfer, to move the objectives and change the business model resulting in start-up and becoming more active in business development processes (Reinventing tech transfer. Nature Biotechnology 2014).

We talked with Maria Luisa Nolli, co-founder and CEO NCNbio, a new start-up that deals with technology transfer in biotechnology. With Maria Luisa Nolli, Pharma World Magazine begins a journey of discovery of the main actors of technology transfer in Italy.

What is Technology Transfer?

The technology transfer is usually defined as all the activities of research centers aimed at the assessment, protection and commercialization of technologies and the management of intellectual property developed within research projects conducted by University. Today the biotech world can not do without these activities, because all biotechnology products, whether drugs, medical or diagnostic devices, have a high scientific and technological content that requires skills that Company does not always have alone. The only scientific knowledge does not guarantee the research product to arrive on the market and therefore the access of a patient to an innovative therapy. The link between the University and the Company is precisely the Technology Transfer.

Why do we need of a structure dedicated to technology transfer and not just a collaboration between University and Company?

First of all, we need new forms of investment to support especially the initial stages of development of a product on which the Company hardly bet. Indeed, usually the Company invests on a drug not before phase II, after the clinical trial in the case of a medical device and only after the demonstration of feasibility in clinical practice in the case of a diagnostic. The financial support can obviously come from different sources; these include government funding programs (in Europe the current Horizon 2020 program, in the USA the NIH programs). Other sources of funding may result from so-called venture capitals, venture capital financing the start-up or growth of activities in the high development potential sectors, or from small Biotech companies which start to accelerate the development of a product until it reach an interesting step for Big Pharma. This scenario places the technology transfer activities. This way if not properly supported can become very difficult and tiring, that’s why besides the financial support needed fiscal measures and incentives to intellectual property protection. Recently in Italy came into force measures such as the status of young innovative enterprise and the patent box that aim to facilitate this initial path.

What does Technology Transfer do?

The process is complex and involves different professionals; the activities depend on each individual project and the actors that go around. Technology transfer is not only about the transition from University to the Company, but specifically involves all phases of the development chain, to the market and often even further because all phases are very high-tech. I refer, for example, to the time when the project is transferred to a spin-off and from the spin-off to the Company. But the technology transfer does not end when the project enters into the Company, because for all biotech products (drugs or diagnostic devices) it’s important to monitor the maintenance of their original characteristics.

The actors involved in technology transfer are many and with different skills and include: basic researchers, project managers, financial, lawyers, regulatory experts, persons with expertise in trademarks and patents, and some who have already gained industrial experience. The aim of this multidisciplinary team is to create an ad hoc process that allows the selected project to move from basic research to become a product with suitable characteristics to the placing on the market.

The objective of Technology Transfer is thus identify research projects that can become interesting products for the market. At a time of crisis and general paucity of funds, we do not risk the abandonment of basic research by University?

I’s important that UniversitY basic and applied research are balanced; only in this way can be a “continuum” between creativity, innovative projects, protection of intellectual property through patents and their exploitation to the market. This is an internal academy management problem.

Who are the main actors of Technology Transfer in Italy?

In Italy there are Offices/Departments within Universities, Research Centers as well as technology parks, entirely dedicated to technology transfer (TTO Technology Transfer Office). Examples are the TTO San Raffaele Hospital in Milan, The TTO of University in Milan and Bologna, the Bioindustry Park Silvano Fumero in Ivrea, the Polytechnic of Milan or Tuscany Life Science at Siena and many others. Recently they are then rising private companies, who deal with technology transfer, such as TTFactor, which manages innovation to IFOM (FIRC Institute of Molecular Oncology) and IEO (European Institute of Oncology). The involvement of these structures within or close to the Research Centers can help you decide where to invest in the protection of intellectual property directing it to a product idea. But of this we will discuss in more detail and depth in one of the next stages of our “journey” to discover the Technology Transfer.