Archives: Agenda

• What changes for sponsors when EHDS, eIDAS 2.0 wallets, the Data Governance Act and the AI Act converge on clinical trial data infrastructure.
• Why current consent and audit-trail architectures will not survive a participant’s right to revoke or port their data, and what the Nordic region is already building as the working answer: consent evidence ledgers, privacy-preserving computation, and neutral data altruism intermediaries

• Sharing practical examples of what has worked (and what hasn’t)
• Highlighting key challenges and how to overcome them
• Comparing tools in terms of ease of implementation, cost, and impact for smaller teams
• Exploring which solutions are realistically adoptable within limited resources and existing systems

In recent years, some of the most damaging cyberattacks in Europe share a common thread – identity. As traditional defences strengthen, attackers have shifted tactics, moving away from malware and exploits toward abusing legitimate credentials, permissions, and trust relationships within enterprise environments.

This session considers how attackers use identities to navigate industry-standard defences. We’ll explore the anatomy of an identity-based attack – from initial access through to organisational-wide takeover – and highlight recurring patterns seen across European enterprises.

Today’s breaches aren’t the result of poor security but of unseen complexity. Hidden identity attack paths buried deep in Active Directory and Entra ID provide adversaries with millions of routes to critical systems.

We’ll conclude with a strategy to move from reactive defence to proactive identity risk management. By continuously mapping and removing identity attack paths, organisations can eliminate the bridges adversaries depend on.

• Comparing timelines and setup across the UK EU and other key regions
• Understanding trade-offs between speed cost quality and patient access
• Deciding how to prioritise regions based on trial type and strategy

Moderator Tina Karunaratne, Founder and President, Bridge to Compassionate Care

• Identifying how clinical strategy and data quality impact investment decisions
• Translating investor expectations into practical changes in trial design and execution
• Applying these insights to improve funding strategy in a tougher market

Moderator: Alexander Booth, Host, Lab to Lives Podcast

• Sharing practical learnings and experiences from Phase 1 of the “all-in-one” pilot
• Exploring what is changing in Phase 2 and what sponsors can expect from the expanded framework
• Understanding how coordinated assessment could simplify studies involving medicinal products, IVDs and medical devices
• Looking ahead at the wider COMBINE programme and how its learnings could inform future approaches to combined studies

• Designing an FIH study to generate an early proof-of-concept signal alongside safety and tolerability data
• Selecting FeNO as a practical biomarker to rapidly assess anti-inflammatory activity in asthma patients
• Demonstrating a 50% reduction in mean FeNO after just three days of treatment while maintaining minimal systemic exposure
• Exploring the operational decisions that enabled rapid assessment of healthy volunteers and asthma patients within the same early-phase programme
• Translating early clinical and biomarker data into clear evidence to support the next stage of development