BIOSPAIN 2026

The ongoing challenges at Europe's borders and beyond, the lingering effects of COVID-19, and the shifting landscape of biological threats have fundamentally reshaped the way Europe must approach its biologic sector. Vaccines, therapeutics, and diagnostics are no longer just healthcare solutions, they are essential strategic assets. Europe's ability to produce these tools quickly, at scale, and on home soil has become a cornerstone of both defense and crisis resilience.

This session brings together key leaders from Europe’s defense, health security, and intelligence sectors to tackle a crucial question: What infrastructure, coordination, procurement strategies, and alliance frameworks does Europe need to ensure its biologics production meets the demands of future crises? By leveraging lessons from recent events and the strategic insights currently driving EU and national plans, panelists will evaluate Europe’s manufacturing readiness, the strategic role of stockpiles, the integration of intelligence in preparedness, and the necessary public-private collaboration to turn strategic goals into operational capabilities.

Since the launch of the BioBasque strategy in 2002, Euskadi has invested in consolidating an innovation ecosystem which supports the growth of the health and life sciences industry. Under the overarching strategy of clusters as models for growth of sophisticated sectors, a sustained institutional support and the public-private collaboration have leveraged the development of a growing industry currently comprised of more than 300 companies (including specialised suppliers) that account for more than 8% of the direct employment in the Basque Country. The industry is also supported and accompanied by the Basque Network of Science, Technology and Innovation, composed of a rich tissue of organisations (Universities, BERC, Cooperativa Research Centres-CIC, Technology Centres gathered in BRTA, and Health Research Institutes among others) which provides skilled capabilities and contribute to generate deeptech start ups.


Since 2015, the industry has experienced very significant growth in the number of companies (60%), and particularly in terms of turnover (187%) and employment (151%). Most of this growth has been endogenous; even today, the generation of innovative and tech companies in the health/life sciences area remains strong (first in Spain, in number of companies per capita). However, in the recent past, the region is becoming an attractive location for companies, and people, that decide to relocate or establish operations and grow their business here.


This session will explore the factors that make the Basque Country attractive, from different points of view including international companies, investors, and researchers, as well as the Basque Health Cluster and the health public administration.

Eikonoklastes Therapeu cs, TBC 

The year 2025 has been marked by the Biotech Act, the proposed Regulation through which the European Commission aims to establish a comprehensive regulatory framework to foster investment, innovation, and competitiveness in the biotechnology sector at a pivotal moment for Europe's strategic autonomy.
Against this backdrop, this session will explore how the Biotech Act represents an opportunity to strengthen the competitiveness of the Spanish biotechnology sector. In particular, the discussion will focus on some of the proposals expected to have the greatest impact on the industry, including Strategic Projects, financing pilots, the extension of the Supplementary Protection Certificate (SPC), and measures to accelerate clinical trials.

Artificial intelligence is reshaping every stage of the pharmaceutical innovation pathway, from the identification of novel therapeutic targets to clinical development, regulatory decision-making and patient access. The convergence of next-generation sequencing, integrative multi-omics, advanced machine learning and emerging European health data infrastructures is creating unprecedented opportunities to accelerate the development of safer, more effective and more personalized medicines.

This round table will gather leaders from government, biotechnology, the pharmaceutical industry and biomedical research to explore how AI is transforming the entire drug development continuum. The discussion will examine how next-generation sequencing and the integration of genomics, transcriptomics, proteomics, metabolomics and other complementary data sources are enabling a deeper understanding of disease biology, improving target identification and validation, and advancing biomarker discovery for precision medicine.

The conversation will then address the application of AI throughout clinical development, including trial design, patient stratification, digital endpoints, real-world evidence generation and regulatory science. Particular attention will be given to the opportunities created by the European Health Data Space (EHDS), which will provide an unprecedented framework for the secure and responsible secondary use of health data to support biomedical research, innovation and evidence generation across Europe.

Beyond the technological advances, the panel will discuss the governance, interoperability and trust frameworks required to translate AI into clinical and societal value. Speakers will also consider how emerging European policy initiatives, including the forthcoming European Biotech Act, can strengthen Europe's innovation ecosystem by fostering investment, enabling responsible data sharing, supporting regulatory innovation and reinforcing the continent's competitiveness in AI-enabled biotechnology.

Bringing together perspectives from industry, academia and public administration, this session will offer a strategic discussion on how Europe—and Spain in particular—can leverage artificial intelligence, integrative 'omics and health data to accelerate biomedical innovation while ensuring scientific excellence, regulatory confidence and better outcomes for patients.

Following the publication of the proposed Biotech Act I Regulation, the European Commission has launched a consultation process for the future Biotech Act II, which will focus on industrial policy and on building a broad, forward-looking biotechnology ecosystem.In this session, organised by AseBio, we will examine the opportunities presented by Biotech Act II to advance biomanufacturing and biotechnology innovation in Europe, while also addressing the regulatory, financing, and scale-up challenges facing the sector.

Artificial intelligence is transforming medical devices, particularly software-based technologies for early disease detection and personalised healthcare. However, in 2026 AI-powered medical devices in Europe will operate under a dual regulatory framework shaped by Regulation (EU) 2017/745 (MDR) and the Artificial Intelligence Act, creating one of the most complex compliance environments globally.
This session will bring together a Notified Body representative, a startup with an AI-based speech analysis platform for early detection of dementia, Parkinson’s disease and cardiovascular conditions, and regulatory strategy experts. The panel will provide a multidisciplinary and practice-oriented discussion on how innovative AI solutions can successfully reach the European market.
Key discussion points include:

• Qualification and classification of AI-based software as medical devices
• Clinical evidence expectations for machine learning systems
• Lifecycle management of adaptive algorithms
• Interaction between MDR and the AI Act requirements
• Data governance and high-risk AI systems
• Regulatory pitfalls and common deficiencies identified by Notified Bodies
• Strategic considerations for startups scaling internationally

The discussion will address whether Europe can maintain global competitiveness in digital health while ensuring patient safety and regulatory robustness. By combining regulatory authority perspective, industry experience and strategic advisory insight, this session offers a practical roadmap for innovators navigating AI medical device development in Europe.

Regional biotechnology clusters and associations play a vital role in strengthening the biotechnology ecosystem by promoting collaboration among stakeholders, facilitating knowledge transfer, and accelerating the scientific and business development of the sector. Their work enhances the competitiveness of biotechnology companies while reinforcing the innovation and growth potential of their respective regions.

The aim of this session is to examine the role of biotechnology clusters and bioregions in the development of the sector, explore how they collaborate with one another, and identify the key strengths and challenges across different regions, highlighting both shared priorities and the distinctive characteristics of each regional ecosystem. The discussion will also address the Biotech Act proposal to promote networks of biotechnology clusters as a means of strengthening competitiveness and fostering collaboration across the European biotechnology sector.

Human-derived substances are at the forefront of a new wave of biomedical innovation, spanning cell therapies, microbiome-based interventions, and advanced medicinal products. As these technologies rapidly evolve, so too does the complexity of the regulatory landscape governing their development and clinical application within the European Union.
This session will explore the scientific, clinical, and regulatory dimensions of substances of human origin (SoHO), with a focus on how emerging frameworks aim to balance patient safety, ethical considerations, and innovation. Experts will provide insights into the latest EU regulatory developments, including classification challenges, compliance pathways, and the implications of the evolving SoHO regulation.
A featured perspective from industry will highlight real-world translation, showcasing how cutting-edge companies—such as those working in microbiome therapeutics—navigate regulatory uncertainty while advancing novel therapies toward the clinic. The discussion will emphasize practical strategies for stakeholders across biotech, healthcare, and policy to effectively bring human-derived innovations to market.
Join us to unpack what truly constitutes “substance” in today’s biotech ecosystem—and how Europe is shaping its future.

Imagine a crossroads where human health, animal welfare, and the environment meet — and a new generation of sentinels stands guard. This panel will convene those sentinels to tackle the urgent challenge of protecting vulnerable people and animals from disease driven by major antibiotic‑resistant threats, and to showcase the bleeding‑edge tools that spot and dissect multidrug‑resistant bacteria across clinical, food and environmental landscapes within a One Health framework. We’ll voyage through the knotted realities of vaccine development and market access, then move into the fast‑moving world of diagnostics: gene‑based LAMP assays that turn hours into minutes, electrochemical biosensors that read microbial whispers as electrical signals, nanomaterial‑amplified methods that reveal the faintest traces of pathogens, microfluidic “lab on a chip” platforms that miniaturize whole laboratories, and point‑of‑care systems built for real‑world decisions. The growing appreciation for vaccines—from immune surrogates of protection to fresh insights into host‑pathogen dynamics and sharper disease definitions—will be explored as a keystone for prevention. Recent breakthroughs already sound like science fiction: sub‑hour detection of key AMR genes, ultra‑low limits of detection in messy samples, and real‑time antimicrobial susceptibility testing that brings clinical and research timelines into alignment. These advances not only sharpen bedside decision making but also feed drug discovery with high‑resolution pathogen profiles that accelerate new antimicrobial development. The panel will bring together thought leaders in vaccines, diagnostics, microfluidics, biosensing, environmental microbiology, and pharmaceutical innovation to chart the next frontiers in AMR detection — and to imagine how those frontiers will reshape the hunt for tomorrow’s drugs.

Introduction – The One Health Challenge of MDR Bacteria

Block 1 - From Immunity to Impact: Building Executable AMR Vaccines
Block 2 – Genetic Detection of MDR Bacteria: LAMP and Other Rapid Molecular Techniques
Block 3 – Electrochemical Biosensing: Fast, Sensitive Characterization of MDR Bacteria
Block 4 – Point of Care Devices and Lab on a Chip Systems for Rapid AMR Decision-Making
Block 5 - Connecting Diagnostics to Drug Developement: TheFeedback Loop

Looking ahead to 2035, what single technological or ecosystem change would have the greatest impact on transforming AMR detection from a reactive activity into a predictive and actionable One Health system?