Category: blog

  • EU pharmaceutical regulations and market access

    EU pharmaceutical regulations and market access

    How EU Medicine Pricing and Reimbursement Really Works: An Interactive Explainer

    Why can a drug be approved across the entire European Union but still be unavailable to patients in certain member states? The answer lies in the complex system of pharmaceutical pricing, reimbursement, intellectual property protection, supply chain fragility, and access program design that governs how medicines move from laboratory to patient. This interactive group chat walks you through four stories featuring the key stakeholders who shape medicine access in Europe — including the Trump administration’s Most Favored Nation pricing policy, which is now reshaping the incentives of European price negotiations in real time.

    Choose a story and press play

    Use the menu on the left to switch between the four stories. Use the playback controls to start, pause, skip forward, or step back. Adjust the speed to read at your own pace. The abbreviation reference on the right explains technical terms as they appear. Each story has five acts.

    The Cancer Drug

    EMA, Pharma Inc., Germany, Netherlands, Romania, Belgium, Patients, Doctor, Volt Europa

    Glossary

    The core problem

    In the EU, marketing authorisation for a new medicine is handled centrally by the European Medicines Agency (EMA). Once approved, a drug can legally be sold in all 27 member states. However, whether public health insurance will pay for that drug is decided at the national level — each country individually runs a Health Technology Assessment (HTA) and negotiates a price with the manufacturer. This creates a strategic game: companies launch first in high-price countries like Germany and Switzerland to set high reference prices, then delay or skip smaller and lower-income markets entirely. Almost all EU countries use External Price Referencing (EPR), benchmarking their own prices against others, which makes every national price negotiation a global pricing decision in disguise.

    A new external pressure has entered this system: the US Trump administration’s Most Favored Nation (MFN) policy references the lowest prices among 19 OECD countries — including most EU member states — as a ceiling for what Medicare pays. This creates a perverse incentive: aggressive European price negotiation now risks propagating back into the far larger US market. Germany has already introduced confidential pricing options specifically to keep its negotiated prices invisible to the MFN benchmark. The downstream consequences for patient access in lower-income EU member states are still unfolding.

    Even when pricing works as intended, patients still face structural barriers: supply chains built for cost efficiency rather than resilience, medicines that vanish from pharmacy shelves, and a parallel universe of pre-approval access programs that follow commercial logic while being described as charity. The four stories below examine each of these failure modes in turn.

    What you will learn

    Story 1 — The Cancer Drug follows a new oncology drug through the full EU pricing labyrinth: EMA approval, the launch-country sequencing strategy, confidential discount deals, patent thickets blocking generics, and the limits of what EU legislation can actually force.

    Story 2 — The Rare Disease explores orphan drugs for small patient populations, where standard cost-effectiveness thresholds break down entirely, HTA bodies face impossible choices, and patients in Poland wait while patients in Italy are already being treated — with the same drug, for the same disease.

    Story 3 — The Shortage examines why antibiotics disappeared from pharmacy shelves across Europe in 2022–2023: three decades of cost-optimised offshoring, price floors that make manufacturing unviable, 27 fragmented notification systems, and a Critical Medicines Act that monitors better than it enforces.

    Story 4 — Compassionate Use exposes the shadow system of pre-approval access: pharmaceutical companies providing free drugs to dying patients before authorisation — while collecting real-world data for their reimbursement dossier, building physician relationships, and strategically timing programs to create political pressure at HTA decision day. And deciding which countries are “strategic” enough to be included.

    All four stories feature the voices of major stakeholders: the European Commission, pharmaceutical companies, national health authorities, the pharma industry lobby (EFPIA), generic and biosimilar manufacturers, hospital pharmacists, doctors, health insurers, the WHO, patients, and Volt Europa — as well as the US administration as an external actor reshaping the game from outside.

  • From AlphaFold to AIDO: The Evolution of AI-Driven Biology

    From AlphaFold to AIDO: The Evolution of AI-Driven Biology

    From Molecular Prediction to Systems-Level Biological Intelligence

    Computational Biology · AI

    From Molecular Prediction to Systems-Level Biological Intelligence

    AlphaFold gave us the parts list. The next generation of biological AI aims to understand how those parts build living systems.

    Five years ago, Google DeepMind’s AlphaFold fundamentally changed how we understand biology. By solving the 50-year-old protein folding problem, it opened doors that scientists had been pushing against for decades. Today, as we stand on the shoulders of this breakthrough, a new question emerges: What comes after prediction?

    The answer may lie not in better predictions of individual components, but in understanding how those components work together as integrated living systems. This is the premise behind GenBio AI’s AI-Driven Digital Organism (AIDO), which represents a conceptual shift from molecular prediction to systems-level biological intelligence.

    AlphaFold’s Revolutionary Impact

    AlphaFold 2’s impact on structural biology has been profound. With structural predictions for over 240 million proteins, it has empowered more than 3.3 million scientists across 190 countries. The achievement was recognised with the 2024 Nobel Prize in Chemistry, underscoring that a computational method had fundamentally transformed experimental biology.

    But AlphaFold was a starting point, not the finish line. Google DeepMind has since developed an ecosystem of specialised AI tools, each addressing different aspects of molecular biology.

    The DeepMind Biological AI Ecosystem

    AlphaFold 3

    Expands the original breakthrough beyond proteins to predict interactions between DNA, RNA, ligands, and other biomolecules. It achieves 76% accuracy on protein–small molecule interactions and 65% on DNA interactions, significantly outperforming previous computational methods.

    AlphaMissense

    Addresses the challenge of interpreting genetic variants. Of the roughly 4 million missense variants in the human genome, we previously knew the clinical significance of only about 2%. AlphaMissense has now classified 89% of all 71 million possible missense variants as either likely pathogenic or likely benign.

    AlphaProteo

    Moves from prediction to design by creating novel proteins with specific binding properties. This capability is relevant for developing new therapeutics targeting diseases like cancer and diabetes, where designed proteins could serve as entirely new classes of drugs.

    AlphaGenome

    Addresses the 98% of the genome that does not code for proteins. Processing DNA sequences up to 1 million base pairs long, it predicts thousands of molecular properties that characterise gene regulation: the control systems determining when and where genes are expressed.

    Why These Tools Matter

    Each of these models represents a significant advance in applying AI to specific biological challenges. Collectively, they provide accuracy that supports experimental design, the ability to analyse millions of molecules in hours rather than decades, and accessible tools that democratise advanced biological research. These are not incremental improvements. They are fundamental capabilities that did not previously exist, now available to researchers worldwide.

    The Limits of Individual Specialization

    Here is the fundamental challenge: biology does not operate in isolated modules.

    In a living cell, DNA transcription, RNA processing, protein folding, cellular expression, and evolutionary pressures are deeply interconnected parts of a complex, dynamic system where everything influences everything else.

    Illustration of interconnected cellular processes including DNA transcription, RNA processing, and protein folding
    Cellular processes are interconnected across multiple scales, from genetic regulation to protein function.

    Consider drug development as an example. You might use AlphaFold 3 to predict how a drug candidate binds to its target protein with high accuracy. But the next set of questions is harder: How does that binding affect the protein’s function in its cellular context? What downstream effects cascade through regulatory networks? How do genetic variants in different populations affect efficacy? What about off-target effects in other tissues and cell types?

    Current specialised models excel at the first question. The remaining questions require understanding the system as a whole. This is not a criticism of specialised models; it is an acknowledgment that we need complementary approaches to address different levels of biological organisation.

    AIDO: Integrated Systems Biology

    GenBio AI’s AI-Driven Digital Organism (AIDO) takes a different approach. Rather than optimising for specific prediction tasks, AIDO is designed to mirror biology’s inherent interconnectedness.

    The Architecture of Integration

    AIDO comprises six foundation models working in concert: a DNA model with 7 billion parameters trained across 796 species; an RNA model capturing transcriptional dynamics; a protein sequence model for functional prediction; a protein structure model for three-dimensional folding; a single-cell expression model for understanding cellular state; and an evolutionary information model capturing conservation, selection, and phylogenetic relationships.

    What makes AIDO distinctive is not the existence of multiple models, but how they communicate through hierarchical representation propagation and continual pretraining. Information flows between scales, allowing molecular-level understanding to inform cellular predictions and vice versa.

    Unified Task Handling

    AIDO can address up to 300 diverse biological tasks simultaneously. Traditional AI models are typically optimised for one or two specific tasks and perform well on those, but they struggle when reasoning across scales or integrating different types of biological information. AIDO’s architecture is specifically designed for this cross-scale reasoning.

    The stated long-term goal is to move beyond prediction toward biological programming: not just understanding “what is” but designing “what could be.” This requires understanding the design principles governing how components assemble into functional systems and how robustness emerges.

    Why Both Approaches Are Essential

    The future of biological AI is not about choosing between specialised models and integrated systems. Both are necessary and complementary.

    Specialised Models (AlphaFold Family)

    • Exceptional accuracy on well-defined tasks
    • Validated, reliable predictions for specific components
    • Accessible tools for immediate research applications
    • Ground truth for training systems models

    Integrated Systems Models (AIDO)

    • Cross-scale reasoning about biological processes
    • Understanding emergent properties from component interactions
    • Design and engineering of complex biological systems
    • Predictions that account for cellular and organismal context

    Specialised models give us the vocabulary of biology: accurate descriptions of individual elements. Systems models aim to provide the grammar: how those elements combine to create functional meaning.

    Real-World Implications

    The convergence of these approaches opens concrete possibilities across multiple domains.

    Personalized Medicine

    Consider predicting not only whether a patient carries a pathogenic genetic variant, but how that variant propagates effects through cellular networks, how it interacts with other variants in their genome, and how treatments will perform in their specific biological context. This requires both accurate molecular predictions and systems-level integration.

    Drug Discovery

    Beyond predicting drug–target binding, we could simulate a drug’s effects throughout relevant cell types, predict off-target effects, understand resistance mechanisms before they emerge, and design combination therapies that account for systems-level responses.

    Synthetic Biology

    Designing organisms or cellular systems with novel capabilities requires understanding not just individual components but how to assemble them into functional, robust systems. We need both the parts list from specialised models and the assembly logic from systems models.

    Disease Understanding

    Many diseases arise not from single molecular defects but from dysregulation of biological networks. Understanding and treating these conditions requires systems-level thinking informed by accurate molecular predictions.

    The Path Forward

    We are at an inflection point in computational biology. Specialised models have given us unprecedented ability to characterise biological components. Systems-level approaches like AIDO are beginning to explore how those components give rise to emergent properties of living systems.

    The next breakthroughs will likely come from the interplay between these approaches: using specialised models to generate high-quality training data for systems models; using systems models to identify which molecular predictions matter most; developing hybrid architectures that combine task-specific accuracy with cross-scale reasoning; and creating feedback loops where experimental validation improves both types of models.

    This is not just about building better computational tools. It is about developing a quantitative, predictive framework for understanding life at every level of biological organisation. Neither specialised nor systems-level approaches alone are sufficient. Together, they are moving us toward a digital representation of biology that can predict, simulate, and ultimately enable us to engineer living systems.

    We are still in the early chapters of this story. The question is not which approach will prevail, but how quickly we can learn to use them in concert to address the biological challenges that matter most.

    What aspects of this evolution in biological AI are you most excited about?
    Share your thoughts with me on LinkedIn.

  • EU Horizon Europe Research Funding: Data, Trends, and Networks

    EU Horizon Europe Research Funding: Data, Trends, and Networks

    EU Horizon Europe Research Funding: Data, Trends, and Networks

    Research Funding · Data Analysis

    EU Horizon Europe Research Funding: Data, Trends, and Networks

    An analysis of the global distribution of funds, institutional collaboration, and research topics across the 2021–2027 funding period.

    Research funding in Europe is currently more in the spotlight than ever before. With the Horizon Europe programme, the European Union is investing billions of euros in innovation, sustainability, healthcare, and technology. As the 2021–2027 funding period nears its end, it is time to analyse the global distribution of funds, cooperation among institutes, and research topics to support well-informed decisions for both scientists and the EU Commission as they plan for the next funding period.

    The analysis of the Horizon Europe datasets provided valuable insights. The datasets contain information on countries, institutes, their funded projects, and maximum awarded amounts. The core findings, enhanced with interactive visualisations and rankings, are summarised below.

    Which Countries Participate in Horizon Europe Funded Projects?

    Very few countries worldwide have no involvement in European Horizon-funded projects. Russia is one of them. All other countries are colour-coded in the interactive map below. The colour scale is based on the sum of funded projects per country, normalised by the number of funded institutes per country.

    Project involvement per institute by country. Zoom and drag to explore. Colour intensity reflects the ratio of funded projects to funded institutes.

    The highest project involvement per institute is found in European countries such as Greece and Denmark. There are, however, visible differences in project involvement between Eastern and Western Europe. Horizon Europe funded projects also include significant participation from countries across North America, Australia, and Africa, highlighting the programme’s global reach and international collaboration.

    Which Research Institutions Are Most Frequently Involved?

    The bar chart below shows the absolute number of project participations per institution. Each bar is colour-coded by country.

    Top institutions by number of Horizon Europe project participations. Colour represents the institution’s country.

    Funding is concentrated among a few major players that hold leading positions across Europe. The French National Centre for Scientific Research (CNRS) leads by a wide margin, followed by the Spanish National Research Council (CSIC) and Germany’s Fraunhofer Society in second and third place. Notably, Denmark, a comparatively small country, ranks highly with three institutes among the top 20.

    What Are the Funded Research Projects About?

    To answer this question, keywords submitted with the proposals were assessed. The word cloud below shows the top 100 keywords, with the size of each word corresponding to its frequency of occurrence.

    Word cloud of the top 100 keywords from Horizon Europe project proposals, with AI, sustainability, and circular economy among the largest
    Top 100 keywords from Horizon Europe project proposals. Word size corresponds to frequency.

    AI research projects are heavily funded, reflecting the considerable attention this topic received during the most recent proposal evaluations. It is encouraging that sustainability and circular economy also rank highly. However, it is surprising to find so few keywords related to life sciences.

    Which Institutions Receive the Highest Funding?

    The colour coding in the chart below reflects the countries of the institutes.

    Top institutions by total awarded Horizon Europe funding (in euros). Colour represents the institution’s country.

    The CNRS leads by a wide margin, securing approximately €2.55 billion in total funding. The major Spanish and Italian research institutions occupy the next top ranks.

    The Catholic University of Leuven (KU Leuven) stands out as a top recipient of EU research funding, reflecting its exceptional ability to secure substantial grants under Horizon Europe. With more than €170 million awarded across 284 projects, as reported by the university in 2023, KU Leuven owes its success to a well-developed institutional support system, including dedicated grant writing assistance and strong policies fostering innovation. Closely following is the Technical University of Denmark (DTU), which similarly benefits from robust participation in Horizon Europe and other collaborative research initiatives. Both institutions demonstrate how strategic support structures and focused research expertise translate into competitive funding success.

    From Germany, the Fraunhofer Society and the Max Planck Society also rank high, reflecting their prominent role in European research. Following these are smaller universities such as Aarhus (Denmark), Ghent (Belgium), and Lund (Sweden), which are notable for their strong research output relative to their size.

    Which Countries Receive the Highest Funding?

    Total Horizon Europe funding allocation by country.

    A review of the funding allocation by country clearly indicates that Western European nations, specifically Spain, France, Italy, and Germany, receive the highest levels of financial support. This is largely attributable to the high concentration of research institutes in these countries. Spain, for example, receives up to €50 billion over the entire funding period.

    Collaboration Networks

    Collaboration is a key driver of research across Europe and the world, and it ensures that funding is allocated effectively. To better understand the research landscape within Horizon Europe-funded projects, a network-based approach was used to highlight crucial partnerships and identify the most collaborative institutions.

    How to read the networks: Each dot (node) represents one institution. Node colour corresponds to the country, and node size reflects the institution’s participation in Horizon Europe-funded projects. The connections (edges) represent collaborations; their thickness and colour intensity indicate how frequently two institutions collaborate. Hover over a node to see the institution name.

    The first network below includes the top 50 institutions that appear most frequently in the dataset. These institutions participate across many projects, indicating broad activity in the research ecosystem.

    Network of the 50 most frequently participating institutions. Node size reflects project count; edges represent shared project collaborations.

    To take a deeper look at the strongest cooperative relationships, the second network was filtered according to the most frequent collaborating institution pairs.

    Network of the strongest institutional collaboration links. Edge thickness indicates the number of shared projects between two institutions.

    Although many French institutions are centrally located within the network, the networks themselves are highly unclustered. This suggests that European research collaborations extend well beyond the borders of any single country. The leading institutions in France, Spain, Italy, and Germany play a crucial role in maintaining a robust framework for collaborations across Europe. These organisations serve as hubs, enabling and supporting other institutions within the European research ecosystem. Their central position helps ensure strong connectivity and sustained cooperation among diverse partners across the continent.

    Conclusion

    The analysis makes it clear that Horizon Europe is more than a funding programme; it is a catalyst for networking and interdisciplinary collaboration that extends globally. While large institutes and Western European countries hold a dominant position, specific partnerships are fostering the emergence of new research hotspots.

    As the new funding period approaches, the European Commission faces the task of evaluating project topics, while researchers must strategically reconsider their collaborative partnerships.

    Personal Note

    Between 2025 and 2027, key orientations of Horizon Europe projects have shifted towards three priorities: green transition, digital transition, and building a resilient, competitive Europe. While this explains why the word cloud contains only limited keywords related to life sciences, from a cancer researcher’s perspective, I would have hoped to see more than just “health” in very small letters.

    In my assessment, funding priorities will shift to more significantly incorporate the defence sector, while support for sustainability-focused initiatives may decline. Additionally, to foster cohesion and economic resilience, the European Union will likely increase funding directed toward Eastern European countries. It may be an advantage for future funding rounds to seek collaboration partners in Eastern Europe.