Archives: Agenda

Sponsored by Dr. Vince Clinical Research

Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple prizes or Amazon gift cards. The Prize Draw will take place in the Exhibition Hall. Make sure you don’t miss out!

Entries from this prize draw will also be entered into the early birds prize draw at 8.20am on day 2, you must be present to win!

The prize draw will take place in TRACK A: Outsourcing & Clinical Operations

Entries from the day 1 prize draw will be entered into the draw. You must be present to win!

• Embedding a strong internal culture to drive consistent execution, accountability, and scientific rigor across cross-functional clinical teams
• Extending cultural alignment beyond the organization to CROs, labs, and technology partners to enable more effective collaboration and shared ownership
• Improving communication, escalation pathways, and transparency to identify and manage risks earlier in complex, outsourced trial environments
• Accelerating decision-making by aligning expectations, behaviors, and governance across global clinical programs
• Reducing operational friction and delays by proactively addressing cultural misalignment and reinforcing shared ways of working

• When there’s no playbook: Navigating clinical development for a first-of-its-kind therapeutic platform.
• Building the roadmap without getting lost: Making decisions when established endpoints, biomarkers, assays, and development pathways don’t fully apply.
• What founders learn the hard way: Practical lessons, unexpected bottlenecks, and decisions that look very different from inside an emerging biotech.
• AI as a force multiplier: Using AI to accelerate decisions, insights, and execution across clinical development.
• The founder as an orchestrator: Connecting science, CMC, regulatory, clinical, manufacturing, and business decisions when organizational boundaries are still forming.

• Overcoming inconsistent vendor and CRO budget templates and improving mapping into sponsor financial frameworks
• Strengthening financial planning early by streamlining internal approvals, aligning clinical budgets and preventing downstream misalignment and operational delays

Moderator: Kimberley D. Potter, Director of Clinical Operations, Alume Biosciences

• How hidden silos across the sponsor-CRO partnership allow risks to remain invisible until they become timeline, quality or delivery issues
• Why changing the outsourcing model rarely fixes the underlying problem when FSP, full service, milestone-based, outcome-based and hybrid partnerships can all encounter the same execution gaps
• How to close the gap between knowing about a risk and actually acting on it, with clearer ownership of who decides, who acts and when
• Practical ways sponsors can gain earlier visibility into capacity, quality signals, competing priorities and delivery risks without creating another layer of oversight
• How to manage the partnership itself as an operational workstream, with shared ownership of risks, decisions and outcomes rather than relying on governance meetings to create alignment