Expanding Access and Innovation for Italian Patients: Interview with Regina Vasiliou – Vice President and General Manager, Bristol Myers Squibb, Italy

Meeting highlights: 

• Mission for Italian Patients: Regina’s primary mission is ensuring access to BMS treatments for all Italian patients, with four new treatments introduced in 2024 year.

• Elevating Italy’s Profile: Regina aims to elevate Italy’s profile within BMS and with stakeholders, leveraging a favorable political environment and a reform-focused health minister.

• Speeding Up Drug Access: Regina discussed reducing the time for Italian patients to access new drugs, emphasizing the need for further improvements and prioritizing innovative drugs.

• Expanding Therapeutic Areas: BMS is expanding into immunology and neuroscience, with upcoming treatments for diseases like schizophrenia and Alzheimer’s.

• Company Culture and Talent Development: Regina highlighted BMS Italy’s positive culture, recognized as a great workplace, with flexible policies, development programs, and cross-functional collaboration to attract and retain talent.

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EF: What do you want to achieve as General Manager? What mission did you set yourself when you were first appointed, and how has it evolved over the past year and a half? 

RV: I have two main missions. First, I want to ensure that all Italian patients can access our treatments. This year has been very successful; we've made four new therapies reimbursed and available to Italian patients. This brings me great satisfaction. Patient access is crucial. As General Manager, I’m aware of the importance of creating a trustful dialogue with regulatory authorities to bring therapeutic innovation to our country. I realize the significant impact I can have, more than ever imagined, at the start of my career.  

My second mission is to elevate Italy's profile both internally and externally. I took on this role at a fortunate time, with a favorable environment and a new government that values our industry's contributions. The new health minister recognizes the need to reinvent the national healthcare system, which is 45 years old and needs reform. There's now much more political will and openness to change. In the Italian pharmaceutical industry, we are now more united than ever. We've agreed on our priorities, and everyone is aligned on the areas we want to improve. Our goals include reforming the national healthcare system, ensuring faster patient access, and increasing research in the country. It's a great position to be in, and this defines my mission in this new role. 

EF: In specific terms, what needs to happen to improve approvals and reimbursement for faster patient access? 

RV: According to market research, Italy is doing pretty well compared to most European countries, however, we know there is still room for improvement. We're in a good position as 80% of EMA-approved drugs are being made available in Italy, making our country second only to Germany. But there's a gap of over 290 days compared to Germany in access time. Alongside a new health minister who is very attentive to these issues, we also have a new president of AIFA, our regulatory reimbursement body. I was pleased to participate in discussions with him, where he emphasized two key changes in AIFA's vision and communication. The changes are putting the patient at the center and speeding up access to new drugs, especially for those with high unmet medical needs. The benchmark is Germany, and the goal is to make these essential drugs available to all Italian patients immediately after approval. This vision is ambitious but crucial.  

As a company and part of the pharma sector, we share this vision of prioritizing innovation and getting it to patients as early as possible. We're having many discussions with AIFA about potential solutions. One idea is a differentiated review process based on a drug's value. All products and renegotiations follow the same process with identical submission requirements and timelines. One approach could be to prioritize medicines that meet the criteria of innovation, unmet medical needs, and patient value. 

Another approach is to expand Italy's innovative drugs fund to cover more treatments. We've realized the criteria to access the fund were quite stringent, and there are resource savings. We're considering revising these criteria to allow more drugs to be funded. We're also focusing on sustainability and exploring ways to save resources within the healthcare system by investing in innovation. These are just a few examples, but they illustrate our ambition to improve patient access times, even though our current situation is already good, compared to most European countries. 

EF: Could you elaborate on the company's current focus on more novel therapeutic areas, the direction the portfolio is taking, and something exciting coming up that could impact patients? 

RV: We have been active in therapeutic areas like cardiovascular, oncology, and hematology for many years. These areas continue to interest us due to the ongoing unmet medical needs, and we aim to drive innovation there. Recently, we've expanded into immunology, with a new treatment for psoriasis, and neuroscience, with a relatively new treatment for multiple sclerosis. Thanks to acquisitions at the end of last year, we're now focusing on diseases like schizophrenia and Alzheimer's. I'm particularly excited about Alzheimer's, as it's an area with few major developments despite a rising incidence due to Europe's aging population. The Italian government has a dedicated fund for Alzheimer's, highlighting the unmet medical need. 

Our portfolio is evolving, and we aim to provide solutions where they either don't exist or aren't optimal, driving innovation in these areas. What I appreciate about our pipeline is its breadth—covering many compounds and disease areas—and its depth, with different modes of action from biologics and small molecules to CAR T-cells. We're exploring all types of scientific innovation to bring to patients, and working for a company like BMS with such potential is truly a privilege. 

EF: What is strategically significant about Italy and the Italian market to BMS as a global organization? Why is a euro invested in Italy better than a euro invested somewhere else? 

RV: Over the last few years, I've discovered a lot about Italy's pharmaceutical industry role. Originally from Cyprus, I've lived in Italy for ten years and recently learned how significant Italy is as a pharma hub. The pharma industry's contribution to Europe's growth is remarkable, representing one of the country's high-tech sectors with substantial industrial and strategic value. It accounts for 2% of our GDP and employs over 70,000 people.  

In 2023, investments in production and R&D reached €3.6 billion, an increase of almost 9% from 2022. Additionally, more than €700 million is invested annually in clinical research, with 90% from foreign capital companies. This substantial contribution is why the pharma industry receives so much attention from the government and other stakeholders. It drives innovation, exports, employment, and health benefits through clinical trials. 

Our system is recognized as one of the best-performing national health systems in the world. In terms of health, Italy ranks among the top 10 OECD countries for life expectancy at birth, with a figure that is three years higher than the average. With our aging population, health is a crucial topic for the country. This combination of factors has helped me realize the importance of our industry and explains the attention we receive from the government, stakeholders, politicians, and institutions. The stability of the new government is good, and it focuses heavily on the pharma industry, which helps significantly in political debates and opens doors for discussions and idea exchanges. This support is crucial for achieving goals like reforming our national health system, improving patient access, and ensuring sustainability in the mid-to-long term. The openness and access to the government and political dialogue over the past few years are unprecedented. 

EF: How do you distill everything from the digitalization noise into what is useful for you and your team? 

RV: I was invited to Milan Polytechnic Institute to present on AI and its evolution. As an industry, we've made significant progress in employing AI for molecule discovery, clinical trial design, and patient identification for trials. It's impressive to see our hospitals and universities in Italy also leading the way in utilizing AI. However, we've not moved at the same pace in our customer interactions and solutions for patients. This is why we are accelerating our efforts in this area. We plan to employ AI in our commercial operations, ensuring we respect all regulations and legislation. Our goal is to provide the right information to customers at the right time and speed through their preferred communication channels. Starting in the last quarter of this year, we are implementing AI in our commercial operations to improve customer service and, consequently, service to patients. This utilization of technology and AI aims to enhance our interactions and support. 

EF: How do you attract and retain Italy's best talent in such a competitive market? 

RV: It's a challenging task, given the competitive environment. However, BMS is a fantastic company; this sentiment is echoed throughout our organization. We've been recognized as a great place to work for several years, with 14 awards since 2021, including Best Workplaces in Italy, Best Workplaces for Women, and Best Workplaces in Pharma&Biotechnology from Great Place to Work rankings. Our top priority is creating an environment where people can develop, grow, and have fun. While it's not often discussed officially, fostering a climate where employees are happy to come to work and feel they are in the best conditions to excel is crucial. We're committed to achieving this through various initiatives to enhance employee satisfaction and well-being. 

Starting from the basics, we have a flexible working policy and several development programs for our employees. Our diversity and inclusion initiatives are highly appreciated as they allow everyone to bring their true selves to work. Our environment fosters collaboration, especially in Italy, where cross-functional work is seamless. There are no functional silos; everyone shares a common vision and objectives, working together regardless of their roles. This collaboration brings great satisfaction to what we achieve for our patients.  

We ensure good development and succession plans for our talent. We offer opportunities to experiment with different roles through tours of duty. This allows someone to try a different role for six months and decide whether to stay or return. This creates numerous growth and development opportunities. We're also investing in new technologies. This year, we supported a master's program with LUISS Business School on digital health and artificial intelligence, attended by about 70 people across the organization. Participants received accreditation that recognizes their efforts. Additionally, we have coaching programs and mentorship connections internally and externally to support our talent in their career development. These initiatives reflect our commitment to creating an environment where people can grow, develop, and enjoy their work. 

EF: When you look back at the past four years you have been in BMS, what is the one thing you are proud of achieving? What do you think you and your team will celebrate at the end of this year?  

RV: First, we discussed bringing new treatments to Italian patients within the year. Not all companies are fortunate enough to experience such an achievement in a year. It's one of our major celebrations this year. Second, let's talk about our evolving culture. Like many companies, we conduct employee satisfaction surveys. BMS Italy scores the highest in three key areas for our company: first, our employees believe in and support our company strategy; second, they feel comfortable speaking up and sharing their thoughts freely; third, we are effective in removing barriers to execution. While many organizations struggle with these themes, they are our strengths. I'm extremely proud of this and grateful to our leadership team and line managers. This, along with patient access, are significant achievement to celebrate at the end of the year. 

EF: What final message would you like to deliver to our audience and the industry from BMS Italy? 

RV: I want to leave you with the message that BMS Italy is making great progress in delivering treatments to our patients and enhancing our company culture. It's truly a great time and place to be! 

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