Archives: Agenda

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: Lois Wallace, Senior Manager, Clinical Development, SERB Pharmaceuticals

• 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

• Designing efficient start-up strategies that optimize timelines and balance speed, cost, and quality in lean biotech environments
• Making critical early decisions on study location, site selection, and operational setup to drive timelines and success
• Strategically aligning clinical plans with financing milestones, ensuring trials generate the right data to support valuation growth
• Building the right operating model by balancing internal capabilities with CRO and FSP partnerships
• Aligning clinical operations with key value inflection points to maximize investor confidence and long-term development impact