Archives: Agenda

• Selecting the right CDMO for your program balancing speed, quality, flexibility, and long-term scalability
• Building collaborative partnerships that improve communication, accountability, and execution across clinical supply
• Common pitfalls in sponsor–CDMO relationships and how to avoid delays before they happen

• Understanding how recent disruptions including natural events and geopolitical challenges have impacted supply chains
• Learning how sponsors adapted routes suppliers and timelines to keep trials running
• Identifying practical strategies to build flexibility visibility and faster decision making into supply operations

• 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