BIOSPAIN 2026

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 proposed panel creates a strong and complementary storyline around the clinical translation of bioprinting technologies:

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.

Amyotrophic Lateral Sclerosis (ALS) poses 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 ALS. 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 paid to cross-disciplinary collaboration and innovation. 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
• 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.

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.

What would it take to make cooperative enterprises viable at scale in the life sciences ecosystem? How can these models attract investment while preserving their core values? And could they unlock more resilient, inclusive, and patient-centered innovation systems? This roundtable will bring together leaders from healthcare, industry, policy, and cooperative movements to explore the opportunities and limitations of rethinking enterprise models in pharma and beyond.
 
Participantes propuestos

• Representante de RPK (si hubiera opción, pendiente de confirmación)
• Representante de una institución vasca (si hubiera opción, pendiente de confirmación)

How early technical choices sculpt scalability, manufacturability, regulatory success and market readiness. Engineering doesn’t wait for shovels in the ground. It begins the moment a scientist chooses a route in the lab — a decision that can ripple through industrial design, regulatory strategy and the economic fate of a product. This roundtable will celebrate engineering as a continuous creative force across the entire biotech journey — from initial discovery and process development, through industrialization and GMP manufacture, to commercialization. 
 
The goal is to show engineering not as a finishing touch but as a guiding hand that helps teams make smarter choices at every turn. 

1) The role of engineering throughout the product lifecycle Think of engineering as the cartographer, bridge-builder and translator of the development path. When engaged early, it helps teams to: - Anticipate technical risks before they become crises. - Design for scalability so a lab success can grow into a reliable plant process. - Reduce regulatory uncertainty by embedding compliance-minded choices into the workflow. - Smooth technology transfer so knowledge travels cleanly from bench to plant. - Shape industrialization strategies that align process design with real-world constraints. - Strengthen investor confidence by turning technical stories into credible execution plans. - Accelerate time-to-market by avoiding late-stage rework and surprises. At heart, many seemingly late-stage failures trace back to early experimental choices. When engineering is part of those choices, the pathway to market becomes clearer and more navigable. 

2) Crossing the “valleys of death” The development journey is punctuated by perilous transitions — from research to process development, from process development to GMP manufacture, from manufacturing readiness to investor readiness, and from regulatory approval to commercial traction. These so-called “valleys of death” swallow promising innovations when technical, regulatory and economic realities are not anticipated. Introducing engineering thinking early is like building bridges and laying maps across those valleys: it reduces surprises, shortens detours and raises the odds that a promising technology will reach patients and markets.

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.

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.

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.

Rare disease research is entering a transformative era. Advances in precision medicine, in vivo gene editing and novel therapeutic modalities are opening unprecedented opportunities to address conditions that have long lacked effective treatments. However, scientific innovation alone is not sufficient. Translating breakthrough discoveries into accessible therapies requires overcoming significant challenges in clinical development, manufacturing, regulation and healthcare implementation.
This round table will explore the opportunities and barriers shaping the next generation of rare disease therapies, with particular attention to ophthalmology and central nervous system (CNS) disorders. Experts from biotechnology, pharmaceutical industry and translational research will discuss how emerging technologies—including in vivo gene editing and other precision therapeutic approaches—are changing treatment paradigms, while examining practical issues such as innovative clinical trial designs for ultra-rare populations, scalability of development programmes, biomarker-driven patient selection, and the path towards sustainable access.
The discussion will highlight how collaboration between academia, biotech, industry and healthcare systems can accelerate the delivery of innovative therapies to patients, positioning Spain and Europe as key contributors to the future of rare disease innovation.

Potential speakers

• Biobizkaia/Bioaraba