Agenda for Day 2 - Tuesday 10 November, 2026Tuesday, 10 November 2026

Mila Makovec’s remarkable story, where an experimental therapy was developed in less than a year, highlights the groundbreaking potential of personalised medicine to address diseases once thought untreatable. With rapid advancements in gene editing, RNA therapeutics, and platform technologies, the dream of custom medicines is becoming a reality for thousands of patients.

Yet, a pressing question remains: how do we fairly value, fund, and pay for therapies designed for a single patient or small populations?

Be part of this compelling discussion as our expert panel explores the scientific, regulatory, and economic innovations required to transform personalised medicine from exceptional cases into a scalable, sustainable healthcare model.

Key Topics to Be Explored:

• Mila's story: A catalyst for the rise of personalized medicine

• Cutting-edge scientific breakthroughs enabling ultra-targeted therapies

• Navigating regulatory pathways for precision medicines

• Addressing the economic hurdles of developing therapies for small populations

• Pioneering reimbursement and payment models for custom treatments

• The critical role of public-private partnerships in expanding access

• Building a sustainable pipeline to serve future patients

This session promises to inspire and inform, offering actionable insights into the future of precision medicine.

The cardiometabolic space is experiencing a surge in innovation beyond GLP-1 therapies, with emerging mechanisms and novel approaches addressing obesity, diabetes, cardiovascular risk, and metabolic health. This session explores what the latest data reveals about next-generation platforms, examines which targets and modalities are capturing scientific and commercial attention, and discusses where capital and partnerships are flowing. As competition intensifies and the market evolves, the session provides insights into differentiated opportunities and strategic considerations for key stakeholders in this high-growth area.

This year’s Ecosystem Innovation Track at BIO-Europe dives into the transformative forces reshaping biotech and pharma collaboration. From open innovation platforms and cross-border networks to AI-powered ecosystems and regulatory advancements, the agenda brings together global leaders to explore how partnerships, innovation, and integrated strategies are accelerating drug discovery and patient impact.

If you would like to get involved, please contact partneringsponsorship@informa.com

This year’s Ecosystem Innovation Track at BIO-Europe dives into the transformative forces reshaping biotech and pharma collaboration. From open innovation platforms and cross-border networks to AI-powered ecosystems and regulatory advancements, the agenda brings together global leaders to explore how partnerships, innovation, and integrated strategies are accelerating drug discovery and patient impact.

If you would like to get involved, please contact partneringsponsorship@informa.com

Therapeutic breakthroughs are worthless if they do not reach patients. It often takes far too long for innovative therapies to be put into practice. This is because approval, benefit assessment, and pricing are handled by different decision-makers, and decisions are made sequentially rather than in parallel. But what if decision-makers collaborate, pursue a common goal, and make decisions in a single process rather than one after another?

Using case studies, this panel examines how the networked collaboration of decision-makers can facilitate the rapid introduction of medicines in Europe. It showcases how parallel, coordinated processes ensure that patients in Europe gain access to the therapies they need as quickly as possible.

This year’s Ecosystem Innovation Track at BIO-Europe dives into the transformative forces reshaping biotech and pharma collaboration. From open innovation platforms and cross-border networks to AI-powered ecosystems and regulatory advancements, the agenda brings together global leaders to explore how partnerships, innovation, and integrated strategies are accelerating drug discovery and patient impact.

If you would like to get involved, please contact partneringsponsorship@informa.com

Have you ever wondered what the future holds for clinical operations? More importantly, how can we prepare for what lies ahead? This session gives the audience a glimpse into the future by exploring the challenges to come and recommending solutions to implement now, in preparation for tomorrow.

• Explore how AI and global expansion are reshaping clinical trials, unlocking innovation and transforming operational efficiency across international markets

• Discuss the role of community engagement in driving operational excellence, fostering trust and improving patient participation and retention

• Identify disruptive pathways to accelerate trial timelines and navigate the evolving landscape of decentralised trials, patient diversity and digitalization

• Understand how to leverage China’s speed, patient access and regulatory flexibility to accelerate global development timelines

• Explore the surge in licensing agreements between global pharma and Chinese innovators and what makes China attractive for global partnerships

• Understand the regulatory evolution in the regional and their impact on development

• How will the GPL and the Biotech Act create additional incentives for market access?

• Implications of initiatives on regulatory data protection and market exclusivity

• Navigating changes to Supplementary Protection Certificates (SPCs) and their impact on market exclusivity

• Regulatory strategies to maximise available incentives

• Comparing key global differences in approaches to incentives

• Examining the enhanced incentives under updated GPL regulations

• Understanding the baseline for data protection measures

• How to qualify for rewards attached to new indications with significant clinical benefits

• Analysing breakthrough definition for extending exclusivity periods

• Key updates tailored to paediatric medicine advancements

• Regulatory pathways and benefits available for unmet medical need targeted products, and how can they accelerate development and approval?

• How do you define unmet medical needs and that are the thresholds? Navigating the challenge of variable regulatory interpretations across diseases and therapeutic areas

• Case study insight into different conditions and how they qualify for Unmet Need

• Have the changes in the GPL really moved the needle when it comes to stimulating development for unmet medical needs?

CNS remains one of the most challenging yet promising areas in drug development, attracting selective but significant investment and partnership activity. This session analyses recent deal flows, explores what's driving transactions in CNS, and examines the strategic priorities shaping partnerships between biotech innovators and larger players. With new modalities and targets emerging alongside persistent development challenges, the session discusses where value is being created and what matters most for stakeholders creating and evaluating CNS opportunities.

Immunology continues to unlock therapeutic possibilities across autoimmune, inflammatory, and immune-mediated conditions, making it a hotbed for innovation and capital deployment. This session explores emerging targets and novel modalities reshaping the landscape, examines what recent clinical data reveals about efficacy and differentiation, and discusses the deal dynamics and partnership strategies defining the space. As competition intensifies and new frontiers open, the session provides actionable insights for stakeholders creating and assessing opportunities in this dynamic and crowded market.

Longevity science is transitioning from research curiosity to serious commercial opportunity, with interventions aimed at slowing or reversing aging processes gaining scientific credibility and investor attention. This session explores the latest developments in aging biology and health span extension, examines what the emerging data reveals about therapeutic potential, and discusses the investment landscape taking shape around longevity. As funding flows into the space and partnership models evolve, the session provides strategic perspectives for evaluating opportunities in this nascent but rapidly growing field.

Biotech company creation is evolving. Rather than simply financing promising science, a growing number of investors and operator-led platforms are actively building companies from the ground up, combining capital, translational expertise, operational infrastructure, and experienced leadership from day one.

This session will examine the rise of these next-generation venture creation models and how they are reshaping the path from academic discovery to scalable biotech company. Bringing together leaders from venture creation platforms, investment firms, pharma, and innovation ecosystems, the discussion will explore whether biotech company building can become more systematic, capital efficient, and repeatable.

Key themes include:

• The emergence of operator-led biotech creation models

• Institutionalizing company formation around academic innovation

• The role of pharma and ecosystem partnerships

• Fractional leadership and shared operational infrastructure

• Europe’s opportunity to build globally competitive biotech ecosystems

The session will provide strategic insight into how the biotech industry is rethinking not just how companies are funded, but how they are built.

The Ones to Watch sessions at BIO-Europe spotlight emerging biotech companies, innovative startups, or groundbreaking projects that are poised to make a significant impact in the life sciences industry. These sessions provide a platform for showcasing cutting-edge ideas, novel technologies, and promising business models, offering attendees a glimpse into the future of biotech innovation. They are an excellent opportunity for investors, partners, and industry leaders to discover the next big players in the ecosystem.

If you would like to get involved, please contact partneringsponsorship@informa.com

This year’s Ecosystem Innovation Track at BIO-Europe dives into the transformative forces reshaping biotech and pharma collaboration. From open innovation platforms and cross-border networks to AI-powered ecosystems and regulatory advancements, the agenda brings together global leaders to explore how partnerships, innovation, and integrated strategies are accelerating drug discovery and patient impact.

If you would like to get involved, please contact partneringsponsorship@informa.com

For today’s biotech founders, building a company no longer starts with infrastructure it starts with access to the right ecosystem. Incubators backed by global pharma and industry leaders are playing an increasingly central role in shaping the next generation of biotech companies, providing not just space, but capital access, expertise, partnerships, and integrated support networks.
In this fireside chat, a leader from one of the industry’s leading incubator platforms will share what they look for in early-stage companies, how they support founders beyond the lab, and how startups can best leverage ecosystem partnerships to accelerate growth. From navigating early development decisions to building the right partner network, this conversation offers a candid look at how biotech companies are really built today and what founders need to succeed.

• Examine cost-benefit frameworks for bridging studies across Japan, Korea, Taiwan and ASEAN countries, balancing regulatory requirements, ethnic sensitivity considerations and commercial ROI to accelerate regional approvals

• Explore the unique regulatory pathways and requirements across key Asian markets, including PMDA (Japan), MFDS (Korea), TFDA (Taiwan) and emerging frameworks in Southeast Asian nations

• Discuss proven strategies for managing multi-country trials in the region, including site selection and engagement in mature and emerging markets, patient recruitment in heterogeneous populations and building sustainable partnerships with local CROs and research institutions

• Future-Proof emerging opportunities across Southeast Asia's growing clinical trial ecosystem, the rise of decentralized and hybrid trial models adapted to Asian healthcare systems and how to leverage real-world evidence and digital health innovations tailored to local market needs

• Address unique regulatory hurdles and innovative approval pathways for rare disease clinical trials, including adaptive designs and strategies for generating robust evidence with limited patient populations

• Examine the impact of political and leadership changes at the FDA and across global regulatory agencies, and how these shifts influence drug development priorities, review timelines, and enforcement approaches

• Align trial design with evolving regulatory requirements by incorporating real-world evidence, digital endpoints, and quality-by-design principles that strengthen submissions and accelerate approvals

• Discuss Australia’s unique position as a global clinical trial hub

• Examine regulatory advantages, patient recruitment strategies and cost efficiencies

• Explore operational excellence in Australia’s clinical trial landscape

As Europe positions itself as a leading destination for clinical research, the ability to deliver clinical trials at scale requires robust operational frameworks and strategic site management. This fireside chat explores what it takes to transform Europe into a thriving clinical trials hub, examining the critical operational elements that enable successful trial execution across diverse European markets.

• Assess the regulatory, infrastructure, and market factors positioning Europe as an attractive hub for clinical research

• Learn how to evaluate site capabilities and optimize performance using data-driven approaches tailored to Europe's diverse healthcare systems

• Understand best practices for streamlining study initiation processes, managing cross-border logistics, and accelerating timelines

• Highlight opportunities in Eastern Europe, MENA and medium- to low-income countries

• Explore the role of local partnerships in accelerating trial timelines

• Address infrastructure and resource challenges in emerging markets

• EMA guidelines to operationalise the implementation

• Adapting to the evolving EMA network and its role in shaping GPL processes

• Understanding the key changes under GPL and their impact on your regulatory approval

• Practical scenarios: share different perspectives, identify readiness challenges, and discuss recommendations and next steps

• Latest developments in EMA’s regulatory sandbox and the potential for innovation

• Leveraging the IHI BRIDGE project to advance innovative healthcare technologies

• MHRA’s AI airlock sandbox expansion and its implications for biotech innovation

• Evaluating the potential of in-silico technologies to replace pre-clinical and phase I testing

• Understanding the impact of the EU Biotech Act, ATMP, and SoHO Regulations on ATMP development and Biosimilars

• Building a unified approach to Hospital Exemption to accelerate ATMP access and drive Europe's innovation and competitive edge forward

• Comparing the EU regulatory framework with the MHRA Rare Therapies Launch Pad and its support for innovation

• Exploring the FDA’s framework for accelerating individualized therapies and its implications for global competitiveness

• Identifying key strategies for biotech manufacturers to adapt to evolving regulatory requirements and seize new opportunities

• Examining the current state of EU CTR and upcoming changes under the EU Biotech Act

• Comparing the key differences across the US, China, and UK

• Assessing practical impacts on regulatory approval processes and timelines for clinical trials

• Navigating divergent regulatory feedback: understanding similarities and differences in how key global regulators engage with sponsors throughout the regulatory journey