Agenda for Day 3 - Wednesday 11 November, 2026Wednesday, 11 November 2026

Respiratory medicine is evolving beyond traditional therapies and delivery methods, with novel modalities and emerging targets attracting renewed investment interest. This session explores the changing landscape across asthma, COPD, pulmonary fibrosis, and other conditions, examines what recent data reveals about next-generation approaches, and discusses where partnerships and capital are flowing. As innovation accelerates and market dynamics shift, the session identifies differentiated opportunities and strategic considerations for stakeholders in the respiratory space.

Ophthalmology is entering a new era of innovation with emerging therapies, novel delivery systems, and technological advances transforming the prevention and treatment of vision-threatening conditions. This session explores what the latest data reveals about new approaches to retinal diseases, glaucoma, and other ophthalmic conditions, and examines the investment and partnership activity driving the field forward. As deal flow accelerates and commercial opportunities expand, the session provides insights into valuation trends, strategic considerations, and where the most promising opportunities lie in the field.

While regional biotech hubs are thriving, the next frontier is building interconnected, cross-border innovation networks that leverage complementary strengths across geographies. This panel examines how successful ecosystems are collaborating internationally from European emerging life science hubs partnering with established centers, to Asian-European biotech corridors. Panelists will share strategies for navigating regulatory harmonization, cross-border funding mechanisms, talent mobility, and cultural differences while maintaining the agility that makes regional ecosystems successful. The discussion will highlight real-world examples of multi-hub collaborations that have accelerated patient impact.

• Explore critical lessons learned from failed and successful clinical trials

• Gain insights into improving trial design and operational processes

• Examine real world case studies to enhance future trial outcomes

• Explore how CAR-T platforms are bridging autoimmune and oncology indications, leveraging translational insights across disease areas

• Address organizational challenges of working across multiple departments with different priorities and stakeholder expectations

• Navigate recent FDA guidance on cellular therapies and regulatory pathway considerations when bridging from oncology to autoimmune indications

• Discuss strategies for effective cross-functional governance, resource allocation, and operational excellence in dual-indication programs

• Learn how to engage CROs as part of the team

• Minimize risks and enhance clinical trial partnerships

• Building relationships between vendors and biotech companies

• Explore bold and innovative strategies for Phase 3 trials in rare diseases, focusing on risk-taking and challenging existing literature to achieve groundbreaking results.

• Learn how to design clinical trials that differentiate first-in-class therapeutics and position novel therapies for success.

• Discover adaptive, platform, and basket trial designs to enhance efficiency and accelerate the development of breakthrough therapies

• European Health Data Space: sharing digital patient data

• GDPR, anonymization, and secondary use of data considerations

• How does the AI Act interact with GDPR, particularly regarding the use of patient data in AI models?

• Addressing global data-sharing challenges and regulatory considerations

• Update on Darwin Project: full data pilot for non-interventional studies

• Member States’ independent approaches to RWE and its impact on EU-wide consistency

• Intersection of Darwin and EHDS: navigating global transparency and data-sharing challenges

• Addressing regulatory questions in pre- and post-marketing spaces with RWE

• What specific regulatory obligations will companies need to meet under the AI Act?

• How will the regulatory burden of the AI Act impact innovation in drug discovery and development?

• EMA and FDA common principles for AI in medicine development

• Impact of the AI Act and EMA & FDA common principles on the use of AI in drug development and clinical trials including patient recruitment, monitoring, and data analysis

Dermatology is experiencing a surge in innovation and investment interest, driven by advances in biologics, precision medicine, and the growing recognition of skin health's connection to overall wellbeing. This session examines the expanding therapeutic landscape across inflammatory skin diseases, rare dermatologic conditions, and aesthetic medicine, explores what recent data reveals about market dynamics and patient demand, and discusses the deal activity and partnership opportunities emerging in the space. As the field gains commercial momentum, the session highlights strategic considerations for evaluating dermatology opportunities.

Antimicrobial resistance poses one of the most urgent global health threats, yet traditional market dynamics have failed to incentivize adequate investment in new antibiotics and alternative approaches. This session assesses where innovation stands today, identifies critical gaps in the development pipeline and funding landscape, and explores emerging partnership structures, policy incentives, and novel investment frameworks designed to address this challenge. As stakeholders work to align public health imperatives with commercial viability, the session discusses actionable strategies and opportunities for stakeholders committed to combating resistance.

Artificial intelligence is fundamentally reshaping how biotech ecosystems operate, from digital CROs collapsing discovery timelines to AI-native platforms enabling virtual experimentation. This panel explores how AI is creating new models of collaboration across the drug discovery value chain, the infrastructure needed to support AI-driven partnerships, and how traditional pharma, biotech's, and tech companies can build mutually beneficial AI ecosystems. Panelists will discuss practical challenges including data governance, model validation, regulatory considerations, and the skills required to thrive in AI-enabled innovation networks.

• Explore financial barriers in clinical trials and their impact on operations

• Discuss cost-saving strategies and innovative approaches to streamline trial processes

• Highlight mission driven investments that balance capital and clinical impact

• Discover how AI streamlines clinical trial operations- from intelligent protocol development and patient recruitment to digital twin technology that reduces patient requirements while maintaining regulatory compliance

• Learn strategies for shifting from traditional site-centric approaches to patient-focused trial designs that improve accessibility, diversity, and retention through decentralized and hybrid methodologies

• Explore real-world case studies and expert predictions on AI's future impact in precision medicine, regulatory evolution, and the transformation of clinical research operations

• Impact of Biotech Act changes on product development and regulatory timelines

• Adapting to combined assessments for notified bodies

• Addressing delays and inconsistencies in device and diagnostic approvals

• Ensuring compliance with updated MDR and IVDR requirements while fostering innovation

• Navigating market access and competitiveness for advanced therapies and diagnostics in Europe

• Key industry learnings from Joint Clinical Assessment procedures

• Addressing legal challenges and rare disease economic models

• Understanding Member States’ early responses to HTA implementation

• Evaluating whether HTA regulation will streamline market access or introduce new hurdles