Sanofi’s Country Lead, President & Managing Director for Italy Marcello Cattani discusses his career track and explains the company’s broad manufacturing footprint in the country – where Sanofi has four plants. In addition, he comments on the imminent changes to the Italian healthcare system and how the organization is transforming under Paul Hudson’s tenure.

 

Can you begin by outlining your career trajectory up to this point and how you draw on this experience today?

I took my first steps in pharma over 20 years ago at Procter and Gamble (P&G), a company which has traditionally been a disruptor in terms of marketing strategy, and which was a fantastic learning ground for me. After five years at P&G, taking on roles across sales and people management, in late 2006 I joined Genzyme as Product Manager for the company’s Fabry Disease ERT in Italy. This represented a significant shift from my previous experience in traditional pharma, moving into a 100 percent biotech company treating rare diseases which have few patients, few treatment centres, and a highly value-driven purpose.

Following that, I spent seven and a half years at BMS in both local (Italy) and international (Europe and Brazil) roles encompassing medical, commercial, marketing and access. While at BMS, I was charged with overseeing all the company’s most important product launches in Italy, including the first biologic drug for rheumatoid arthritis, as well as treatments in diabetes and oncology, where I oversaw the rollout of treatments for chronic myeloid leukaemia and multiple myeloma. 

In mid-2015 I moved back to Genzyme, by then a Sanofi company, where I led on public affairs, access and communications, and patient advocacy, supporting the transition and integration of Genzyme through Sanofi. Since then, my work has encompassed running a marketing excellence team across all specialty care franchises and leading the onco-haematology franchise. I was appointed General Manager Sanofi Genzyme for Italy and Malta in September 2019, Country Lead – President & Managing Director of Sanofi Italy and Malta in April 2020, all while maintaining direct oversight of the Specialty Care GBU.

I am a scientist by training, with a bachelor’s degree in Molecular Biology, and a Master of Science in Chemical and Food Technology from the University of Parma, which is well known for its expertise in food technology. However, I spent a very short time working in food before P&G poached me and I began my journey through pharma.

 

How challenging was it to take on these broader management roles against the backdrop of the COVID-19 pandemic?

Honestly speaking, it was made far less challenging than it might have been by the fabulous Sanofi Italy team. Working collectively with this talented team during such a trying time has been a real privilege. Our affiliate has always excelled in product launches, creating value and new programs, while fostering forward our talented associated, and we did so throughout the pandemic.

 

Given the geographical proximity of Italy to Sanofi headquarters in France, what is the logic behind the company’s significant Italian footprint and what role does the company play within the country?

Italy is a critical market for Sanofi as our third-largest revenue generator in Europe, after Germany and France. Moreover, we play a pivotal role within the Italian ecosystem and employ over 2,000 associates here across commercial operations, medical affairs, research, and industrial affairs. Italy is important for Sanofi and Sanofi is even more important to the Italian economic and social system. We are one of the top multinational pharma companies operating in Italy and have a truly meaningful impact on the country.

 

How deep is Sanofi’s manufacturing footprint in Italy?

Sanofi has four manufacturing plants in Italy, Origgio in Lombardy, Anagni in Lazio, Scoppito in Abruzzo, and Brindisi in Puglia, all of which have different specialties.

The Origgio plant is one of Sanofi’s global hubs for the production of consumer healthcare products such as probiotics and prebiotics and is now looking toward new production lines in digestive health, coughs and colds, and pain. 

The Anagni site has roughly 400 employees and is focused on sterile and injectable products such as vaccines. It has a strategic role in Sanofi’s potential upcoming COVID-19 vaccine, developed in collaboration with GSK, and will serve not only Italy, but all of  Europe.

Scoppito is focused on innovation, specifically in solid-form drugs, and is a fully integrated factory with more than 250 employees and 50 percent of its production is dedicated to exports, making it a crucial location for international markets. Scoppito has been chosen by the global ‘Columbus High Potent Workshop’ project, looking at manufacturing 4.0, digitalisation, and industrialization of present and future small molecules of our pipeline, so developed by our R&D pipeline or in the future.

Brindisi is a strategic plant mostly producing active pharmaceutical ingredients (APIs) and is part of the EUROAPI initiative, a future leading European company dedicated to the development, production and marketing of APIs. 

During the pandemic, these sites did not stop production and we were able to continue serving patients in Italy and beyond with no backlog or supply continuity issues, which makes me very proud of our amazing teams.

 

Beyond manufacturing, how important is R&D for Sanofi Italy’s operations and what is the scope of the firm’s clinical trial footprint?

Sanofi’s clinical study unit, which covers R&D and clinical trials, is very present in Italy, leveraging the country’s strong network of academic institutions and physicians. It leads not only Italy but also other countries of the Adriatic and Balcan region. Only in 2020, roughly 45 molecules are being tested in Italy in 95 trials across 640 sites, with over 3,000 patients enrolled. 

 

Given your previous work in patient engagement, how would you characterise Italian patients’ level of willingness to enrol in clinical trials?

Italians have long been keen on participating in clinical research. This is even more pronounced today thanks to a greater public understanding of the impact and value of medical innovation and biotechnology, especially new advanced therapy medicinal products (ATMPs). COVID-19 and the incredible speed at which biological vaccines were developed, manufactured, and supplied has also had a big impact on this trend.

Beyond this cutting-edge innovation and biotechnology transition in areas like vaccines, oncology, and rare diseases, there is also a wealth of unmet needs to be addressed through general medicine, consumer healthcare, and nutraceuticals, which we remain committed to.

While the overall environment is extremely positive, there are still improvements to be made in terms of communicating in a more engaging manner and streamlining some of the bureaucracy around patient enrolment and the various ethical committees. While Italy is certainly globally competitive in terms of the standards and professional capabilities of its academic, hospitals and research sites, and therefore of the data they generate, it is perhaps less strong in being able to enrol vast patient populations in short, clearly defined timelines. Having 20 different sub-national health systems creates complexity in terms of rules and technicalities, and also leads to political discussions, as these regions are led by different political parties.

 

The arrival of Paul Hudson as CEO in 2020 seems to have been a breath of fresh air for Sanofi, with clearer growth strategy and a specific focus on different company’s business areas and the launch of multifaceted products like Dupilumab. In European markets like Italy, what mandate were you given and how has the affiliate been performing under your watch this far?

Paul is transforming Sanofi from a traditional pharma into a modern biopharma; investing heavily in new pipeline assets to secure a successful future where Sanofi addresses high unmet medical needs, while foster a deep cultural change to innovation, patient focus, with bold ambition. Dupilumab is for sure a key asset, with a fantastic mechanism of action and the potential for significant impact in several indications, which we are committed to executing locally. 

Here in Italy, the affiliate has been performing very well. This strong performance not only covers financial results, but also innovation of our go-to-market model, within which customer engagement, patient partnerships, digitalization, and omni-channel activity are all now deeply embedded.

As an example of these patient partnerships in action, in rare disease, we are supporting a program of care where enzymes are administered at the patient’s home. The Italian government, through the pandemic, now recognises how big impact such programs can have. Although, due to political considerations, some regions are resistant to this change, we hope that through support and partnership with the Ministry of Health and AIFA all regions will eventually open up to this service and to others like it. Such services help healthcare systems to treat better and embrace a more holistic approach to care, preserving patients’ quality of life through wasting less time in hospitals and easing the burden on hospital resources.

 

What has changed in terms of stakeholder willingness to engage in these kinds of partnerships with pharma companies? Is it a push from the authorities or from patients themselves?

There has been a revolution in thinking among Italians, both individual citizens and the state, and a recognition that good health is beneficial for all. A healthier population will be able to live longer and more successful lives, keep the economy moving forward, and contribute more to society. Therefore, the demand for healthcare is rapidly increasing, like for innovative and specialty drugs as well, a change in behaviour that institutions are following closely. Thanks to technology, physicians and patients are closer than ever before, maximising the benefit of diagnoses and treatments beyond the walls of hospitals or doctors’ offices. 

Patient expectations are also growing and the new Italian government, led by Prime Minister Mario Draghi, has begun to reform the healthcare system to meet these high expectations, reversing a trend of consistent budget cuts over the past decade. This year, the government invested EUR two billion into healthcare, which is a good sign, but is still not a large enough proportion of the total EUR 125 billion budget. More needs to be done to make the big changes that are needed across infrastructure, digitalisation, speed of access to innovation, and bringing the same level of efficiency to Italy’s 20 regional healthcare systems.

 

Realistically, how much impact can we expect these economic reforms to have?

There is a sizeable need for more technicians and pharmaco-economists as well as greater political commitment, but prospects are good, and we are beginning to see changes. Open discussions are now taking place about the contribution, governance, and funding of pharma across both the hospital and retail markets. 

In the hospital sector, funding is relatively low compared to patient demand, which needs to be addressed. The system could work a lot better; for example, savings coming from paybacks currently go to the regions where they are often addressed and not used on areas like schools and social services. While these are, of course, important issues, there needs to be a reassessment of how funds could better be allocated to ensure patient access to innovation. The fact that companies in the hospital sector are paying back around EUR 1.25 billion per year is impacting Italy’s ability to attract investments within Europe. Reform will bolster our competitiveness across the pharma value chain. 

Looking further afield, addressing health is clearly a global challenge. On a global scale there is a clear vision to invest more in pharma and biotech, including in production, to be self-sufficient and better manage future healthcare crises. Therefore, we should seek to re-shore API production in Europe to safeguard our security and sovereignty. Securing healthcare is key for any country’s economic and social development, and must be a key priority for European governments, along with the green and digital transitions.

 

Italy is the top recipient of European COVID recovery funds; I presume you are advocating for this money to be used to secure the future rather than covering up the missteps of the past?

Italy needs to create new methods of public-private cooperation with fewer ideological hang-ups, creating the ability to move more quickly and more flexibly. There needs to be a move towards cross-fertilisation and building up hubs where R&D specialists can work end-to-end with manufacturing, creating more opportunities for start-ups. Italy already has some hubs in Lombardy, Tuscany, and Lazio, but they are not enough. 

However, to achieve this, a strategic political vision and toolkit is needed. The Ministry of Economic Development led by Giancarlo Giorgetti is making good progress, directing European funds towards innovation projects across the healthcare value chain, and we at Sanofi are keen to play a role in any way we can.

In addition to building up infrastructure, technology, and digitalization, talent will be a key issue. Our industry has been strong on hiring graduates with STEM competencies in recent years – in our manufacturing sites, for example, we are looking for processing engineers and biotechnology experts – but there is a significant competition for talent, both from other industries and from other companies. The framework conditions for talent to develop their careers within Italian pharma need to be strengthened and, together with our industry association Farmindustria, we are meeting with several universities and high schools to enlighten students about the prospects available in our industry.

 

Sanofi stands about among its contemporaries for its wide-ranging pipeline of Phase I, II and III drug candidates, many of which are multimodal. Are plans in place to bring all these products to Italy? 

Sanofi has 91 new entities in development – mostly in oncology, immunology, vaccines, and rare disease, where there are high levels of unmet medical need – and plans are in place to bring almost all to Italy. This country has always contributed to Sanofi’s success and the Italian affiliate will be something of a launch machine in the coming years, although our launch timelines are not yet as fast as they could be. Our access, medical affairs, and regulatory teams are in place to capitalise on the high value of our portfolio and – thanks to our strong partnerships with AIFA and the MoH – we are optimistic of being able to roll out many successful launches in the coming years. 

 

Sanofi recently changed its branding, shedding the Pasteur and Genzyme names and releasing a redesigned logo. What is the significance of this move?

This branding change perfectly represents the new purpose of Sanofi “we chase the miracles of science to improve people’s lives”. Strong of our great heritage in patient-centric discoveries, of the combination of different cultures, identities and experiencies sends a clear and positive message about the company’s renewed mission and ambition. 

There are both challenges and opportunities in front of us, not least how to translate our fantastic innovation into meaningful impacts on patients’ lives. We are moving away from the legacy of traditional Big Pharma into a more agile organization that is faster, better, and brings more value to patients than ever before.

 

Do you have a final message to share with our global audience?

We learned during the COVID pandemic to be part of a common team; working together with other companies to produce vaccines against COVID-19 and redoubling our commitment to fighting against diseases in the interest of patients. Through this emergency we proved, as a company and as an industry, our strength, resilience, and innovation. 

The pandemic has also foregrounded our commitment to diversity and teambuilding. Sanofi aims to be seen as a top employer both internally and externally, with great brand recognition and a high level of engagement, and we are well on our way to securing a truly inclusive and human working environment for all our associates.