Making Europe a Leader of the Next Biopharma Revolution
In 2019, during discussions for the last Commission mandate, the world had never heard of COVID-19. Both Europe and the rest of the globe were wholly unprepared for the upheaval that was to grip our societies in the years to come.
Since the end of the pandemic, issues of sovereignty, security of supply and cost cutting have come to dominate the EU health policy debate. While enormously important, if these issues are the focus of the next mandate Europe will be preparing for the last, rather than the next, crisis. Because we cannot solve the most fundamental challenges confronting our societies and health systems without bolstering our capabilities to do cutting edge scientific research in the EU and to discover new medical innovations.
Over the past twenty years, Europe has experienced an erosion of its innovation edge losing a quarter of its share of global R&D investment since 2001[i] and significantly trailing the US as well as emerging competitors as a location for new product development and biotech startups[ii].
To tackle the multiplicity of issues that threaten to overwhelm the continent’s healthcare systems, undermine our economies or indeed, be the agents of the next pandemic, Europe needs to regain its edge in innovation.
Harnessing the AI revolution in science and medicine
If harnessed responsibly and at scale, AI can be a critical tool to solving the most pertinent and costly problems facing Europe’s healthcare systems.
Within Immunology – a field I am most familiar with and in which Europe has an opportunity to become a scientific leader – AI promises to make the process of discovering and developing new medicines and vaccines better and faster.
In interaction with our new scientific understanding of the immune system, AI is already leaving an indelible mark, leading to the development of more first-in-class compounds and ultimately better, more effective medical products to treat and prevent severe (and costly) life-long illnesses.
As EU leaders set their priorities for the next mandate, ensuring European universities, research institutes and companies can be at the forefront of this AI revolution in medicine – and able to deliver breakthrough science that will shape healthcare for decades to come – should be central to the discussion.
Scientific Innovation needs to be the central focus
The Commission proposals on biotech and biomanufacturing[iii] are a good place to start for the next mandate. They are an opportunity to build on Europe’s scientific excellence in areas such as immuno-science – and to consider how we can multiplicate existing capabilities and accelerate the speed of research by deeply embedding AI in our scientific eco-systems.
The increasing incidence of immune-related diseases is an enormous challenge confronting health system and affecting ever more people[iv]. Immune-mediated inflammatory diseases (IMIDs) encompass a heterogeneous group of disorders including more than 100 lifelong and costly illnesses – such as type 1 diabetes, asthma, inflammatory bowel diseases (IBD), rheumatoid arthritis, chronic obstructive pulmonary disease (COPD) and multiple sclerosis – projected to skyrocket in the coming decades.
In recent years, the science of immunology has transformed our understanding of these illnesses. Due to our deeper insights into shared pathogenesis, a diverse set of diseases once thought completely unconnected are now known to share a similar molecular basis and pathology. As a tool, AI is interacting with our new scientific models of immunology to dramatically accelerate scientific discovery, for example helping unlock fundamental genetic mechanisms that underpin immune related diseases and make some people susceptible but others not. AI is also transforming our ability to research complex therapeutics for immune disorders, such as protein and gene-based therapies, accelerating drug discovery across new platforms including monoclonal, bispecific and multi-specific antibodies and mRNA-based vaccines and therapeutics[v]. This is dramatically expanding the potential to delay, treat, cure or prevent many of the life-long chronic diseases for which few options are currently available and which place such a high burden on patients and healthcare systems across Europe.
Europe Can Become a Hub of AI Driven Immuno-Science
Europe is becoming a hub of this new emerging immuno-science, particularly in early-stage R&D.
Interest and investment in clusters such as the Marseille Immunology Biocluster, the Caixa Research Immunology Institute in Barcelona or BioRN in Heidelberg are recognition of the excellence in immunology research in the EU and the dynamism of the biotech sector. As one of Europe’s largest pharma companies, Sanofi is becoming the world’s leading immunology company, partnering for cutting edge research with Immunology Centres of Excellence across Europe.
However, Europe can be at the forefront of the new AI driven science of immunology only if the next Commission mandate and national governments address critical conditions. First and foremost, the next Commission must develop a comprehensive strategy for the Biopharma sector, paralleling what we see with the Chips Act or the Critical Raw Materials, combining industrial, innovation and investment strategies to reinforce both Europe’s cutting-edge science as well as the security and resilience of our healthcare systems. Below are considerations for Europe’s next mandate and biotech plan.
- Accelerate Innovation by unlocking health data and AI for research and manufacturing
AI is nothing without high-quality data. The European Health Data Space (EHDS) has the potential to unleash the power of AI for Health in Europe.
Data sharing will be key – but it’s essential the right structures are in place. Over the years Sanofi has been a leader in our willingness to share data with other researchers and – once there are appropriate protections built in to protect confidential information – sharing research data is something we wholeheartedly support. However, the EHDS carries significant risks and may have unintended consequences for data sharing in Europe. As the next Commission begins to implement the EHDS, it must engage the expertise of researchers, companies, and patient organizations to solve fundamental issues and ensure it serves its purpose of creating a rich health data ecosystem to drive research, with patient trust and accountability being front of mind.
Several other policy considerations in the next Commission will be critical for AI in health.
In terms of hardware, the deployment of the European quantum computing infrastructure will be an essential enabler of AI in drug discovery.
Skills will be essential. The EU has some of the best universities in the world and some of the best mathematicians, biologists, chemists, engineers, and data scientists.
All together this means the EU has the raw materials to be at the forefront of health AI. Strategically, the EU needs to focus on creating centres of excellence to harness and direct this talent.
Finally, responsible AI is innovative AI. The implementation of the new EU AI Act will be essential to ensure Europeans can trust what AI has to offer. Sanofi is fully aligned with the risk-based approach of the new act. This approach, following strict moral, ethical, and environmental standard has been embedded since the beginning into our development and use of AI through our RAISE initiative[vi].
- Future Proof IP and Regulatory Frameworks for complex therapeutics and vaccines
The revision of the general pharma legislation, which will continue into the next mandate, is a once-in-a-generation opportunity for future proofing the regulatory and incentives landscape to encourage the development of more complex medicines and vaccines with the assistance of AI in Europe – particularly for patients with unmet needs or those with rare conditions. Reducing incentives for innovation will not help European competitiveness, but more importantly is not in the best interests of patients. The next Commission must also future proof related healthcare regulations. With an eye to improving the attractiveness of Europe as a location for clinical trials, the next Commission should review and simplify the Clinical Trials Regulation.
- Securing biotech supply chains and enabling diversification
The Commission must be given a mandate to secure a diversity of technology platforms in Europe, as well as facilitating partnerships and international cooperation on biomanufacturing platforms. For instance, consortiums for raw materials and components exchange would be valuable for the European region as part of our preparedness for major disruptions, as would EU level planning for alternative and new critical raw materials essential for the biomanufacturing of future products in Europe.
- Foster innovation clusters in leading fields
Fostering innovation clusters in areas such as immunology, where Europe is already a leader and has the critical mass and proximity between research, care, and companies should be central to the next mandate plans.
HERA could play a more important role in building a strong ecosystem for late-stage development in the EU.
Collaborative planning should identify gaps and opportunities, decrease fragmentation, encourage specialization in specific areas and most importantly, plan with a European mindset rather than a national one.
[i] Charles River Associates (2022) Factors affecting the Location of Biopharmaceutical Investments and Implications for European Policy Priorities, Study for
[ii] See, for instance, Deu, L.F. and Santos da Silva, J. (2019) Biotech in Europe: A strong foundation for growth and innovation. McKinsey Report
[iii] European Commission (2024) Building the Future with Nature: Boosting Biotechnology and Biomanufacturing in the EU.
[iv] p. 4, GBD 2019 IMID Collaborators. (2023) Global, regional, and national incidence of six major immune-mediated inflammatory diseases: findings from the global burden of disease study 2019, Lancet (Vol. 64, Oct. 2023)
[v] For recent advances in AI driven drug discovery see Arnold, C. (2023) Inside the Nascent Industry of AI Designed Drugs. Nature, (Vol.29, June)
[vi] For further information on Responsible AI at Sanofi see ‘Artificial Intelligence across Sanofi’
