Archives: Agenda

Most Sponsors and CROs have made the move to RBQM at an operational level – but is the approach actually intelligent, or is it still driven by manual review cycles, static risk thresholds and teams buried in reporting?

• Moving from operational RBQM to AI-enabled RBQM that learns, adapts and surfaces the right signals before they become issues
• Identifying where operational RBQM is still leaving value on the table and where AI can create a step change in quality and efficiency
• Examining what the data shows about improvements in speed, accuracy and cost
• Achieving real-time inspection readiness for Sponsors and building a quality capability that helps CROs win and retain business

• Understanding how the new UK framework is working in practice 6 months after implementation
• Identifying key operational changes, including approvals, consent, and trial setup
• Clarifying how sponsors can take advantage of faster pathways while staying compliant

• Exploring the meaning of risk sharing across roles
• Supporting balance between procurement and R&D priorities
• Strengthening partnership models through transparency

Moderator

Alexander Booth, Host, Lab to Lives Podcast

• Defining clear roles and responsibilities between sponsor and CRO to avoid duplication and gaps
• Identifying what sponsors should actively oversee versus what can be delegated with confidence
• Setting oversight models that focus on risk rather than excessive monitoring
• Improving communication and escalation pathways to prevent delays and misalignment

Formula One solved twenty years ago what clinical trials are still working on: designing the pressure out before the lights go on. This talk explores what we can learn from the fastest teams on earth, how our industry can adjust and how those lessons apply to cell and gene therapy in neuroscience and rare disease.

• Live data, live decisions: moving from retrospective reporting to real-time operational intelligence so enrollment, safety and site performance data can guide decisions while they still make a difference.
• Designed handovers, not heroic firefighting: rehearsing the sequence across regulatory, contracts, drug supply and training before the study starts so site activation becomes fast, predictable and scalable across regions.
• Adaptive by default, efficient by design: treating adaptability and cost discipline as one engineering problem rather than a trade-off in cell and gene therapy for neuroscience and rare disease where every patient counts.