BIOSPAIN 2026

Spanish biotech spin-offs are stepping onto the global stage like nimble launchpads of innovation, pulling in investors and partners from Europe, the US and Asia. Rooted in world-class science yet built for translation, they marry academic brilliance with entrepreneurial grit — and with sharper international branding, smoother regulatory pathways and bolder cross-border alliances, they can turn local discoveries into scalable, globe-spanning solutions.

Advanced Therapies and Next-Gen Biotech Platforms to Deliver Global Health Impact
Given the relative strength of the Basque Country in industrial biotechnology capabilities—particularly in advanced manufacturing, regenerative medicine, and translational research—this proposal envisions a coherent set of 2–3 interconnected BIOSPAIN 2026 sessions exploring advanced therapies and next-generation biotech platforms from complementary perspectives. Rather than a single discussion, the aim is to reflect the breadth and maturity of the regional ecosystem by distributing expertise across multiple formats, including thematic panels and moderated discussions.
These sessions would collectively examine how scientific innovation, industrial scale-up, and clinical translation converge to enable global impact in advanced therapies. While each session would address a distinct angle—from platform technologies and manufacturing infrastructure to translational science and clinical application—they would be designed to offer a unified narrative around the Basque Country’s role as a European hub for advanced biomedicine.
Across the proposed sessions, participation would include leading voices from biotechnology companies, industrial-scale manufacturing organizations, and academic and translational research institutions:
The session provides a review of platform technologies and genome engineering, industrialization and manufacturing of gene and cell therapies, and translational research and clinical integration, depending on final program design.
Overall, this proposal aims to showcase the Basque Country’s distinctive positioning at the intersection of industrial capability, scientific excellence, and translational innovation, illustrating how regional strengths can be leveraged to drive global health impact in advanced therapies through coordinated, multi-stakeholder dialogue.

Quantum technologies are rapidly evolving from theoretical promise to practical tools across biomedicine and biotechnology. Early applications in drug discovery, molecular simulation, quantum enhanced imaging, and secure data infrastructures are already underway, supported by hybrid quantum–classical approaches and pioneering industrial collaborations. This panel will bring together experts from quantum computing, biotechnology, diagnostics, and cybersecurity to explore near term opportunities and realistic pathways for adoption.
Participants will gain insights into emerging use cases, regulatory considerations, and strategic actions enabling biotech and health organizations to prepare for the quantum decade ahead.

Introduction: Why Quantum for Biotech Now? (5 min)

Block 1 – Quantum Computing in Biomedicine: Molecules, Models and Precision Medicine (20 min)

Block 2 – Quantum Sensing, Imaging and Diagnostics: The Next Frontier (20 min)

Block 3 – Quantum Biotech Industrial Collaborations and Biomanufacturing (20 min)

1. Mujer TBC, Multiverse Computing
2. Javier Aizpurua, Scientific director, BasQ-Basque Quantum Strategy TBC

Following a market correction, ATMPs are entering a more selective phase where scientific promise must be matched by clear execution. This session will examine what differentiates companies that get funded, scaled, and ultimately acquired. The discussion will focus on investor selection criteria at seed and Series A, including data thresholds, platform differentiation, and capital efficiency. It will also address the role of delivery and manufacturing in enabling—or limiting—scalability. From a pharma perspective, the panel will highlight what drives partnering and acquisition decisions, and why many ATMP companies fail to reach that stage. Bringing together investors, founders, pharma, and manufacturing experts, the session will provide a practical framework to assess ATMP opportunities in today’s environment.

• Regulatoria: AEMPS o alguna empresa experta en el tema (ej.: Asphalion o Clarek + Modet). TBC
• Legislación: un perfil que conozca la legislación y marco europeo (aquí sugeriríamos alguien de Vinces) TBC

5. Legislative perspective: VINCES???

Women specificities in healthcare are gaining importance due to the higher socieconomical status in developed countries and insights from research highlighting sex and gender disparities in the development, prevention and treatment of diseases. As an example, cardiovascular disease remains the leading cause of death among women in the EU, yet it is still under-researched, frequently misdiagnosed, and often undertreated. Understanding women's health requires moving beyond a "one-size-fits-all" medical model to one that recognizes the profound impact of sex and gender on health outcomes and considers the differential needs in prevention and treatment. In parallel, there is a growing high-tech market delivering new healthcare products and services specifically designed for women, the so-called femtech sector, with innovations specifically designed for women’s wellness or care related to diagnostic devices, wearable sensors, etc. This panel will analyze this healthcare paradigm change and the related technological innovations as well as the integration of these aspects into routine clinical workflows by multidisciplinary experts including a cardiologist with expertise in digital health and AI, pharma and femtech companies.

• Representante de Abbvie –TBC.
• Representante de Qassay –TBC.

Bioprinting is rapidly evolving from an emerging laboratory technology into a transformative clinical platform with the potential to redefine regenerative medicine. This roundtable will bring together key European stakeholders from biofabrication, robotics, clinical translation and advanced manufacturing to discuss how bioprinting can successfully move from research environments into real-world medical practice.
Through complementary perspectives, the discussion will address the major challenges and opportunities facing the field: unmet clinical needs, in vivo bioprinting, robotic-assisted biofabrication, industrial scalability, regulatory pathways, hospital integration and next-generation regenerative therapies. The session aims to provide a realistic and strategic vision of how the clinical future of bioprinting can be built.
The roundtable would be moderated by Andrea García Lizarribar (TECNALIA), who will guide the discussion around the technological, clinical and industrial pathways required to accelerate the adoption of biofabrication technologies in healthcare.
The proposed panel creates a strong and complementary storyline around the clinical translation of bioprinting technologies:

• Enabling technologies and manufacturing platforms → REGEMAT 3D

Together, the panel balances:

• clinical perspective
• industrial scalability
• enabling technologies
• advanced therapies
• future-oriented innovation
• while maintaining a realistic and high-impact discussion on how bioprinting can successfully transition from research laboratories into clinical practice.

The session offers a unique opportunity to showcase how European innovation ecosystems are shaping the future of clinically applicable biofabrication technologies.

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.

Fishing in the Atlantic Marine Biotech Innovation Ecosystem: A Comprehensive Examination of Emerging Scientific and Technological Potential, Pathways for Development and Commercialization, Policy and Governance Challenges, and the Tangible Societal Impacts on Coastal Economies, Public Health, Biodiversity Conservation, and Community Resilience This expanded formulation frames a broad, multi-dimensional exploration of the Atlantic marine biotechnology and fisheries landscape — tracing how basic research and nascent technologies move through translational development, entrepreneurship, and regulatory systems into real-world applications. It highlights interconnected topics such as sustainable resource management, value-chain innovation (from bioprospecting to bio-based products), equity and livelihoods for coastal communities, environmental and biodiversity considerations, and measurable benefits to public health, regional economies, and social well-being. The emphasis is on understanding not just the scientific potential but also the institutional, economic, and societal mechanisms that determine whether innovations deliver meaningful, equitable impact.

Representative of A4F

As biologics and advanced therapies—including proteins, antibodies, and ATMPs—reshape the therapeutic landscape, the key challenge is no longer only scientific, but industrial. This roundtable will explore how CDMOs are evolving beyond isolated capabilities into integrated, platform-driven ecosystems that accelerate development, reduce risk, and enable efficient path-to-patient.


Rather than focusing solely on technologies, the discussion will highlight how collaboration across specialized players—viral vector developers, biologics manufacturers, and fill-finish experts—can create seamless development pathways. The goal is to understand how to connect early innovation with robust, scalable, and compliant manufacturing strategies.
Key Discussion Topics

• Platforms as enablers: How standardized platforms can reduce timelines and costs, while balancing the need for flexibility in complex and novel therapies.



•  End-to-end thinking: The importance of integrating drug substance and drug product considerations early to avoid late-stage challenges.


• Scaling advanced therapies: Key bottlenecks in moving from clinical to commercial manufacturing, particularly for ATMPs and viral vectors.


• The power of proximity: Why close collaboration between CDMO teams and developers is critical to accelerate decision-making, knowledge transfer, and execution.

Differentiation Angle:

This session will provide a strategic perspective on how to move from fragmented innovation to coordinated industrial execution—combining platform efficiency with collaboration—to ultimately deliver complex therapies to patients faster and more reliably.

The successful translation of early-stage oncology research into therapies that reach patients requires more than scientific excellence. It demands effective collaboration among researchers, technology transfer professionals, biotech companies, patient organizations, investors, and funding institutions. As Europe increasingly embraces collaborative and impact-driven innovation models, new approaches are emerging to bridge the gap between discovery and clinical application.

This roundtable will explore how structured collaboration can accelerate oncology innovation and improve the likelihood that promising discoveries reach patients. Using real-world examples from the oncology innovation ecosystem, the session will highlight how coordinated support mechanisms can de-risk early-stage projects, strengthen translational pathways, and ensure patient needs are integrated from the outset.
The discussion will address key drivers transforming oncology drug development, including:

• Advances in molecular biology, genomics, and biomarker-driven clinical development that are enabling more precise and targeted therapeutic strategies.
• The growing use of real-world data (RWD) and real-world evidence (RWE) to inform clinical development and decision-making.
• The integration of patient perspectives from the earliest stages of research, ensuring that scientific priorities, development pathways, and innovation outcomes reflect real clinical needs and patient experiences.
• The application of artificial intelligence and machine learning across the R&D continuum, from target identification and drug discovery to biomarker development, clinical trial optimization, patient recruitment, and prediction of treatment response and toxicity.

Bringing together perspectives from academia, venture capital, biotech SMEs, patient advocacy organizations, and innovation support entities, the session will provide actionable insights into how collaborative ecosystems can accelerate oncology innovation and create greater translational impact.

A particular focus will be placed on the role of innovation support and incubation programs in identifying high-potential research projects and transforming them into investable opportunities. Speakers will discuss how early definition of an investment thesis—grounded in patient benefit, societal impact, and commercial potential—can strengthen project development and attract follow-on investment. The session will also explore how venture capital investors increasingly contribute beyond financing, actively supporting project evaluation, strategic positioning, and market alignment from the earliest stages. AECC, the Spanish Association Against Cancer, will present their pioneering Patient Advocacy programme its complemnetarity to their  newTechnology Transfer Program.

Representatives from Oncomatryx, Naru Intelligence, and Hawk Biosystems will share their experiences in developing cutting-edge technologies, including antibody-drug conjugates (ADCs), AI-driven clinical research solutions, and next-generation spatial proteomics platforms.

By showcasing successful examples of cross-sector collaboration, this session will demonstrate how coordinated innovation ecosystems can accelerate the journey from laboratory discovery to patient benefit.
Participants will gain practical insights into building investable, patient-centered oncology projects and fostering partnerships that accelerate translation and market adoption.


Proposed Panelists

• Representative, AECC Patient Advocacy Program / AECC INNOVA or AECC IMPACTO initiatives?

A silent storm is sweeping the globe: chronic kidney failure touches more than 850 million lives, ranks ninth among causes of death, and affects roughly 10% of the world’s population. In Spain alone, 15% of adults live with chronic kidney disease and about 68,000 people require dialysis or transplant to survive. Spain stands out as a beacon of transplant medicine — performing more than 6,000 kidney transplants a year and consistently leading the world in donor rates and clinical outcomes. Yet even a success story must evolve. To truly conquer organ shortages, extend long-term graft survival, and free patients from lifelong immunosuppression, bold innovation is essential. The horizon is already changing: xenotransplantation, advanced machine perfusion for organ preservation, robotic-assisted surgery (an area where Spain is a trailblazer), and AI-driven donor–recipient matching are reshaping what’s possible. Transplantation is re-emerging as a frontier of therapeutic invention, offering a rare opportunity to recast how drugs and biologics are developed for complex, high-stakes indications. Spain’s dense, high-volume clinical landscape offers an exceptional proving ground to accelerate next-generation drug development. By weaving together model-informed drug development, adaptive and innovative trial designs, and early regulatory alignment, we can shorten timelines, reduce development risk, and create more efficient clinical programs. The complexity of transplant studies — patient heterogeneity, long timelines, and shifting endpoints — demands this kind of nimble, collaborative approach. What’s needed now is stronger partnership between clinical centers, industry, regulators, and patient organizations to build an integrated ecosystem for transplant-focused innovation. The upcoming round table will explore how Spain can leverage its clinical excellence to become a global reference for transplant drug development, and how a forward-looking, coordinated strategy can turn today’s promise into tomorrow’s cures.

Imagine a kitchen where tiny, tireless chefs—yeast, bacteria, or fungi—are taught new recipes at the molecular level. That is precision fermentation: a carefully controlled, biology-driven process that programs microorganisms to churn out specific food ingredients, from enzymes and flavor molecules to structurally complex proteins. Using modern genetic and metabolic engineering, these microbial artisans produce high-purity molecules that once came only from animals or cumbersome extraction processes, offering a platform that’s predictable, scalable, and potentially kinder to the planet.

One of the clearest and most evocative examples of this approach is the creation of recombinant caseins. Caseins—the alpha, beta and kappa family members that give milk its character—are the architect proteins that assemble into micelles, creating milk’s texture, emulsifying power, and its ability to be turned into curds for cheese.

That said, the path from fermenter to supermarket shelf has practical hurdles: regulatory approval pathways, production economics, downstream processing and quality control, supply-chain integration, and consumer acceptance all matter. Overcoming these requires engineering, rigorous testing, smart economics, and clear communication about safety and benefits.

Potential speakers

• LEVPROT: Sabemos que están trabajando en temas de proteínas dulces por fermentación de precisión
• NOVONESIS: Creemos que es una empresa muy potente que puede tener tirón.
• Cocoon
• AZTI??

A guided tour of Spain’s biomedical frontier: where tomorrow’s therapies are being born, who’s driving them, which technologies enable them, and how to convert those breakthroughs into investment and company-building opportunities

Neurodegenerative diseases such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), and Alzheimer's Disease continue to pose major scientific, clinical, and societal challenges. At the same time, unprecedented advances in molecular biology, drug discovery, biomarkers, precision medicine, and advanced therapeutic approaches are transforming the landscape of neurological research and care.

This round table will bring together leading experts from academia, biotechnology, and clinical practice to discuss the latest innovations driving the development of next-generation therapies for neurodegenerative disorders. The discussion will explore emerging therapeutic strategies, including novel small molecules, biologics, regenerative and gene-based approaches, as well as the critical role of translational research in accelerating their path to patients.
Participants will examine how cutting-edge discoveries are being validated through clinical studies and real-world evidence, addressing key challenges related to efficacy assessment, biomarker development, patient stratification, regulatory pathways, and long-term outcomes. Particular attention will be given to lessons learned across ALS, MS, and Alzheimer's disease, highlighting opportunities for cross-disciplinary collaboration and innovation.

Featuring insights from Adolfo López de Munain, representatives of Golden Gait Biotech and CIC bioGUNE, and Ana Martínez Gil, the session will provide a comprehensive perspective on how scientific breakthroughs are advancing from the laboratory to clinical validation and, ultimately, to improved patient outcomes.

Key themes:

• Advanced therapeutic approaches for ALS, MS, and Alzheimer's disease
• Translational pathways from discovery to clinical application
• Biomarkers and patient stratification for precision neurology
• Clinical trial innovation and real-world evidence generation
• Collaboration between academia, healthcare systems, and biotech companies
• Future opportunities and challenges in neurodegenerative disease treatment development

This discussion will offer attendees a unique opportunity to gain insights into the evolving neurodegenerative disease ecosystem and the strategies shaping the next generation of therapeutic innovation.

Speakers

Mónica Povedano, Hospital Univ. Bellvitge, Neurology Service, TBC
Quimatryx, TBA
BMS?

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 (5 min)
Block 1 - From Immunity to Impact: Building Executable AMR Vaccines (15 min)
Block 2 – Genetic Detection of MDR Bacteria: LAMP and Other Rapid Molecular Techniques (15 min)
Block 3 – Electrochemical Biosensing: Fast, Sensitive Characterization of MDR Bacteria (15 min)
Block 4 – Point of Care Devices and Lab on a Chip Systems for Rapid AMR Decision-Making (15 min)
Block 5 – Connecting Diagnostics to Drug Development: The Feedback Loop (10 min)

The integration of biotechnology, software, and artificial intelligence is redefining the development of advanced solutions for diagnosis, patient stratifica on, and precision medicine. However, the effective transla on of these innovations into the European clinical environment requires going beyond analytical performance or the experimental validation of biomarkers. It also requires the ability to design robust, interoperable, and regulatorily aligned systems capable of integrating into complex and highly standardized healthcare ecosystems.

This round table will examine how to build biotech solutions powered by soware and AI under an interoperability-by-design approach, incorporating from the earliest stages aspects such as data architecture, semantic standardization, traceability, algorithmic governance, and regulatory compliance. In the European context, frameworks such as the European Health Data Space (EHDS), the AI Act, and the regulations applicable to medical devices and in vitro diagnostics (MDR/IVDR) are shaping a new paradigm in which evidence generation, data quality, and the capacity for technical and semantic integra on are inseparable from clinical value and market viability.

As a practical case, the presentation will address the use of AI in digital histopathology for biomarker iden fica on, an area of par cular relevance due to its poten al in precision oncology and its high methodological complexity. The combina on of digital imaging, computational analysis, and correla on with molecular and clinical data makes it possible to move toward more reproducible and scalable models of ssue characteriza on. However, its effective implementation depends on the harmonization of formats, pre-analytical and analytical quality, clinical validation, and interoperability with pathology systems, electronic health records, and biomedical data platforms. Innovation in AI-based biotechnology cannot be understood solely as an algorithmic challenge. Interoperability is no longer an IT project; it is strategic infrastructure for enabling European biotech to scale with AI.

AEMPS???