Archives: Agenda

Clinical supply forecasting and RTSM systems have traditionally operated as separate entities. This session examines the compelling case for unifying these systems and the benefits that can accrue. Is this the future of clinical supply management? What does this imply for your studies.

In this session we will look at:

•  Operational challenges encountered in forecasting and RTSM systems seen as discrete solutions
• Common integration models and why they fall short
• The unified solution and its closed-loop capabilities
• Business benefits including efficiency; cost savings and risk reduction

Join us to explore how this unification can transform clinical supply management from a reactive, manual process into a proactive, data-driven capability that reduces costs and risk and optimises clinical supply.

• 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

• 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

• 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

• 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