Aldo Sterpone, Grünenthal Italia’s General Manager, outlines the company’s focus on pain and its efforts to bring innovation to the area through R&D and acquisitions. He also explains the importance of Italy as one of Grünenthal’s manufacturing hubs.

To begin, can you outline your career and what brought you to Grünenthal?

I have been working for a little bit more than 30 years in the pharmaceutical industry. I have worked for several companies, mainly multinationals, in both a national and international environment. I can say that 28 of those 30 years have been in international settings. I worked for Novartis, for AstraZeneca, for Amgen, and for Roche, in several different roles: sales, marketing, national and international.

Having covered most of the different areas that are particular to the pharmaceutical industrial, I joined Grünenthal in 2018 as GM for Italy. Grünenthal is a company that is really focused on patients and one of the areas that is affecting patients broadly across all geographies and impacting their quality of life. The area is pain. Pain is something that is not yet considered as it should be, but it impacts patients, caregivers and families heavily, especially if we talk about chronic pain. It is something that makes us work hard to find new innovative solutions, but also to keep going with the solutions we already have, making sure they are used appropriately across the globe to improve patients’ lives.

 

This is the first time you have worked as a country head. What would you say about the experience, looking back on the four years you have spent in the role so far?

Looking back at these four years, I am happy because in Italy we have been growing, at least in the first part of that period. We have been able to put very relevant services and initiatives in place to not only shape the market but also the environment and make the authorities and stakeholders pay more attention to the way pain patients are treated and managed. In Italy, we have a law, law 38, which was set up a little over 10 years ago to enable better pain management across the country. But there is still a lot of work to be done to fully implement the law across Italy. Thus, we are working harder in terms of relationships with clinicians and the authorities to understand the appropriate management of chronic pain. Pain, and specifically chronic pain, is something that can impact heavily the economic and social aspects of the country.

 

You mentioned that pain is not taken into proper consideration. Is this changing?

In most cases, unfortunately, pain is simply considered a symptom of something else, of a disease. Chronic pain has now been recognized as a disease, per se, which means we should deal with chronic pain as something that is affecting and impacting patients’ overall quality of life. Chronic pain affects a huge number of people and is always underestimated because data are not widely available, but one out of five people suffer from chronic pain, not just in Italy, but across the globe. Therefore, having proper treatments and proper management of the disease can make a huge difference. It is drawing a lot of attention from the authorities also because the cost is huge with an estimated EUR 300 billion due to the consequences of chronic pain in Europe.

 

How exactly does Grünenthal tackle pain? What is the company’s clinical approach?

We are one of the few companies focusing heavily on pain. There are not many companies working on pain because is not an easy area in which to bring new innovative products to patients. If you look back at the last few years and the registration of new products by the European Medicine Agency (EMA), you will not find any pain products among them, which tells us two things. One, that there are few companies working on pain. The other is that it is not easy to bring innovation to the area of pain. That is why we decided to review and reorganize our R&D a couple of years ago, take on the open innovation approach and start collaboration with some excellence centres like the one in Boston. We reshaped our way of doing R&D because the first pillar of our strategy is innovation. We have five pillars, in fact: innovation, growth, acquisition, efficiency and people. So, we decided to review our way of working and focus all our R&D efforts and resources on four areas within pain: lower back pain, osteoarthritis, local neuropathic pain, and postoperative pain.

Then there is the acquisition area. We are working a lot in terms of business development, and we have acquired some products that were beneficial to setting up the shape of the company to attract investments in order to fund R&D in a more relevant way. We recently acquired a Swiss company, Mestex, with a product called MTX-071 (Resiniferatoxin) that is in phase III. It is a product that will treat patients with osteoarthritis of the knee, working to reduce the pain and postponing the need for surgery.

We are also focusing a lot on Qutenza and launched it in the US. Its mechanism of action strongly reduces neuropathic pain. The first year in the US has been very promising in terms of results, usage of the product, acceptance, adoption by clinicians, and more importantly, in term of feedback from patients.

 

Speaking of pain management in different countries, in the US for example, with its highly privatised system, there was the opioid crisis. What would you say about how clinicians handle pain in Italy?

In Italy, thanks to the law that I mentioned earlier, the attention to pain has been increasing over the years. However, there are still quite significant differences across the regions, in term of application of law 38 and this results in significantly different approaches to patients with diversified patient journeys. In many cases patients do not reach the appropriate specialist as soon as they should, going on for years before getting the correct diagnosis and the appropriate treatments.

This is something we need to work hard to improve and to introduce some kind of standardisation to ensure that all patients with chronic pain can be properly treated at the right time by the right specialist.

Another important point to be highlighted for Italy is the appropriate use of available treatments. Because of law 38, the use of pain treatments, even opioid treatments, is very carefully managed in Italy and there are no signs of an opioid crisis or anything similar here because, fortunately, we have a very regulated environment.

 

Perhaps this is a good moment for Italy to look at patient journeys along with the consequences of COVID, if we consider the package the country has received from the European Commission. What are your thoughts on the lessons learned from the pandemic and how the EC funds should be used?

We can say that COVID-19 taught us very important lessons that we were not aware of before the pandemic: the fact that health is fundamental for all other aspects of life. That is very important and what we saw was the fact that many patients were left alone with their diseases and were not able to go to the hospital and were not even able to get a doctor to visit them at home. That was particularly true for pain patients who were obliged to manage their pain by themselves, which was not correct or fair or humanly acceptable. What we need to do now is take advantage of this moment, not just of the money coming from the EC’s Next Generation Europe plan, because money without ideas is not going to change anything. We need to combine the effect of the funding with the ideas that were born during the pandemic; ideas like telemedicine and smaller local hospitals.

These local hospitals will be a first reference point for patients where they will be able to go directly to be initially managed. Yet what is even more important, as I said before, is to keep working on the journey, on the next step in the patient journey, to make all the people working in these centres able to send these patients to the appropriate specialists. These people need to be aware and well informed in order to take the right steps to manage patients properly and send them to the appropriate specialists for the next phases of the journey. On top of that, we are working with the Italian association of anaesthesiologists and pain therapists in order to set up a telemedicine project that can help manage patients, even without asking the patients to go to a special centre. When we talk about chronic pain, in most cases, we are talking about elderly patients who are not always able to move. All the technological advances that have taken place over the years must be made available to offer proper management also in a virtual way which also requires training because managing patients from a distance is not the same as doing it in person.

 

You spoke about virtual management, but do you think the physical presence of medical reps is still important?

As an industry we are probably behind other sectors in terms of technological advances and ways of working. Now the reps are present in the field again after the pandemic and pharma companies are focused again on a face-to-face approach; that remains a very important pillar of the relationship but we also need to step up and evolve our way of working. That will bring the ability to manage relationships with clinicians with an omnichannel approach, not just face-to-face, but working to keep the relationship open, even between physical visits. For example, remote calls or webinars; there are many opportunities to make our relationships more open with external stakeholders, and at the same time more efficient.

 

Talent is one of Grünenthal’s pillars. What would you say about Italian talent?  Of course, Italy is known for its creativity, but how reactive would you say your people are to change?

Yes, we are very creative, but in some cases, we are not good at implementation, and I think you need both things. Implementation is something we need to work on every day, because it is probably not a part of our DNA. In Italy, I see a lot of young people, including at Grünenthal, that are very focused, and very committed to these new approaches and are also able to give strong input and make more effort on the implementation side. That makes me confident that we can go faster on that and improve quickly. Obviously, this is also related to our ability as leaders to steer and motivate people to further improve in this area, and to keep working on it. It is not just their responsibility, but it is even more our responsibility to incentivise them, properly recognising success along the way.

 

What is the importance of Italy for Grünenthal?

Italy is extremely important in the Grünenthal world, for a couple of reasons. One is the importance of the commercial affiliates in the overall balance of Grünenthal worldwide. We are the third biggest affiliate in the world for Grünenthal, after Germany and Spain.

The other reason why Italy is extremely important for Grünenthal is that Italy has a production and manufacturing site that is Grünenthal’s top site in the  world. It is a top-notch facility that came out as one of the best in an external survey done by McKinsey of 1,000 sites across the world. It was built in the 1970s, employs more than 400 people and occupies an area of 50,000 square meters. Taken over by Grünenthal in 1996 from an Italian pharmaceutical company, it has been completely renovated over the years. It is also where we have recently been reshoring and a new building has been set up to produce an anti-migraine product, taking this production from oversees and bringing it to Italy. In addition, the site is also working for other companies and we have put in place several CDMOs there.

 

Looking at the future, what direction would you like to see the Italian affiliate taking over the next few years?

The future for Grünenthal Italy is focused on pain. Pain will remain our area of focus and where we want to be considered as leaders. We are already a leader in the pain area, but we want to keep going, keeping this leadership and advancing new innovative medicines. Also, through our way of managing our customers and managing our presence in the Italian environment: further strengthening our skills and competencies in digital and omnichannel and further strengthening our ability to collaborate with institutions. For example, we sponsored a very important initiative at the end of last year: a poster on pain put together by the Italian association of anaesthesiologists in order to improve the management of pain patients across Italy. We want to keep partnering on initiatives like this that can improve the life of patients. On top of that, our future in Italy will be more characterised by our industrial presence, which we will continue to be reinforced and improved.