Read the Conversation
EF: What attracted you to join Sobi?
RL: I spent around more than a decade at Novartis, my first job in the pharmaceutical industry after consulting. It was an amazing experience for me, like attending a great school. During my time there, I got to work in various countries like Spain, Italy, the UK, Ireland, and Switzerland, taking on different roles. I was involved in the company's transformation efforts in my last position. I wanted to return to a General Management role, preferably in Spain. That's when I got in touch with Sobi, and the opportunity aligned perfectly. It was the right moment to broaden my horizons and gain more diverse experience. While I had a wide-ranging background at Novartis, most of my work centered on oncology, hematology, and rare diseases. This new Sobi role focused on rare diseases and strongly emphasized hematology, which was a perfect fit for me: having the opportunity to transform the lives of people living with rare diseases in Spain and Portugal.
EF: Can you give us context and background on how the areas of focus are evolving in Sobi?
RL: Sobi is a biopharmaceutical company focused on rare diseases. Our headquarters are located in Stockholm, Sweden, and we operate in more than 70 countries worldwide. The company specializes in the therapeutic areas of hematology and immunology, and we also have a range of Specialty Care products. In hematology, we are leaders in hemophilia A and B, and we treat Immune Thrombocytopenia (ITP) or Paroxysmal Nocturnal Hemoglobinuria (PNH). In the near future, we will be entering the field of on-hematology. In the area of immunology, we have a presence in the field of autoinflammatory conditions such as Still's disease, Cryopyrin-Associated Periodic Syndromes (CAPS), and Familial Mediterranean Fever.
EF: How would you describe the strategic significance of Spain and Portugal to this global group? If you're talking to HQ to attract resources, what is your pitch for why Spain is such an important market?
RL: Spain's market size is relatively small compared to top world countries, accounting for about 10% of Europe and 3% globally. However, Spain typically ranks in the top five markets in Europe alongside Germany, France, Italy, and the UK. While Spain may seem small in comparison, it's a significant market globally, often ranking in the top 10 in terms of sales. Despite its size, Spain excels in clinical trials, fast growth, and innovation. The country has an innovative mindset, and although it may lag in access to healthcare compared to some other countries, Spanish doctors are often early adopters of new technologies and treatments. In both Sobi's and my previous roles, Spain has consistently performed well, sometimes even matching or approaching the levels of the US in terms of scientific achievements beyond just sales metrics.
EF: How do you assess the reimbursement process in Spain, especially with the different autonomous regions having to work individually? What challenges do you face in that respect?
RL: Of the five countries I've worked in, Spain stands out as one of the most complex markets, particularly within the European Community. The decentralized healthcare system adds another layer of complexity, requiring approvals at the national, regional, and, many times, hospital levels. This makes access strategies crucial, with access teams playing a critical role in navigating these complexities; for companies, it is critical to establish permanent dialogue processes with the different administrations and actors involved in the process of access to medicines. While Italy shares some similarities, Spain is generally considered more complex and difficult regarding market access.
EF: How are you working beyond the treatment to improve awareness and the lives of the people you treat, for example, with the document you presented to the Senate, the Coordenadas?
RL: In Sobi, we seek answers to the challenges and demands faced by patients with rare diseases, healthcare professionals, and authorities. For this reason, we have developed the institutional program "acERca las enfermedades raras" (Engaging with Rare Diseases). This program helps us to understand the reality of patients with rare diseases and comprehend the impact these conditions have, both on them and their surroundings. With this collective knowledge, we aim to seek solutions.
In the specific project “Coordenadas” (Coordinates), over the past year, a group of experts in rare diseases has identified the best practices from each autonomous community to serve as guidance for improving comprehensive patient care. At the Senate, we have made their conclusions available to all institutions, professionals, and patient associations. Consequently, the final document includes indicators proposing advancements toward achieving comprehensive care, promoting diagnosis, and developing personalized therapeutic plans for each patient.
EF: How do you see the use of technology and artificial intelligence in healthcare, and how do you see the importance of big data in advanced research and clinical care?
RL: Reality and mapping are distinct concepts. In Spain, there are 17 autonomous regions, each with its decentralized healthcare system, often disconnected from one another. This means that sharing healthcare data is challenging, as each region operates independently, with some hospitals even isolated from others within the same area. While the country generates significant data, we are all challenged to become better organized and connected to use that data more effectively. Additionally, healthcare models vary across regions; for instance, neonatal screening protocols differ, with some regions conducting 43 tests and others only 7.
Access to healthcare also varies depending on where you live, which our company aims to address. Surprisingly, only nine out of the 17 regions in Spain have a rare disease plan in place. The first rare disease plan in Spain was approved in 2009, coinciding with the start of my career in rare diseases. However, despite significant changes in the past decade, the document has not been updated since 2014. While discussions on big data and advancements like AI are important, many fundamental elements are still lacking to leverage these opportunities. It's crucial to have these basics in place to maximize potential. Often, we overestimate progress in the short term and underestimate it in the long term. I believe that many doctors and GPs will soon have AI tools to aid decision-making, but the challenge lies in organizing and managing the data effectively. While companies like Google have attempted to enter the healthcare sector, bridging the gap between data from various hospitals and systems remains a significant challenge.
EF: What needs to happen, and how can we get all stakeholders on the same page to move things forward and update the rare diseases plan?
RL: As a company, we're proactive in raising awareness about rare diseases and what improvements are needed in the healthcare system for these patients. It is still essential to raise awareness about the reality of the three million people in Spain who live with a rare disease. At Sobi, we are aware of this need, which is why we created the institutional program "acERca las Enfermedades Raras" (About Rare Diseases), which cleverly plays with the term "ER" in Spanish. We use it to get closer to the reality of patients with rare diseases and to learn about the comprehensive impact they have, both on them and on their environment. We use it to get closer to the reality of patients with rare diseases and to learn about the comprehensive impact they have, both on them and on their environment.
We've produced two significant documents: one is “33 proposals to improve the lives of people with respiratory diseases”. This document, developed in collaboration with stakeholders, including doctors, payers, patients, hospital managers, and politicians, offers 33 recommendations for enhancing the management of rare diseases. Additionally, this year, we released "Coordenadas," which I have told you about before. Our efforts extend beyond raising awareness about rare diseases. We also engage with patient groups, associations, and stakeholders to influence positive change within the healthcare system. The key is to put the disease and the characteristics of orphan drugs into context: a small number of patients and treatments with conditional approvals... The challenge is to bring this vision to the health system as a whole.
EF: You have quite a strong late-stage pipeline with several molecules in phase three and the registration process; how is it evolving? Is there something you're excited about bringing to the market?
RL: Over the past 3-4 years, we've consistently launched at least one new product annually, which is significant considering the size of Sobi. First, we introduced an innovative product for ITP, bringing substantial improvements compared to existing options. Last year, from a Spanish perspective, we launched a groundbreaking Paroxysmal Nocturnal Hemoglobinuria (PNH) product in May, improving patient outcomes. Next year, we plan to launch another transformative product in the hemophilia market, further solidifying our position. While disruptive innovations are often emphasized, most of our innovations are gradual improvements built upon previous successes. Our short-term focus remains on advancing these incremental innovations. We aim to enter the lymphoma market in the next two years and later expand into the C3 market with a product we currently have for hematology but adapted for nephrology. This outlines our strategic direction for the next 2-3 years.
EF: Do you have any message for our readers or anything we did not talk about and you think is important to raise awareness on?
RL: The pharmaceutical industry has always been innovative in product development but remains traditional in other areas. Unlike the banking sector, for example, which has shifted to digital platforms, we still largely rely on traditional methods to engage customers and navigate the healthcare system. Despite discussions about digital transformation, the industry has been slow to adopt new go-to-market models. However, this will change, especially with the potential integration of AI and other tools. In the future, teams may include experts in data alongside medical, marketing, and sales professionals, as algorithms play a more significant role in decision-making. These changes will impact everything from clinical trials to treatment decisions, requiring a shift in our approach and skill sets. While these changes may not happen overnight, they are inevitable and will shape the future of our industry.
