Archives: Agenda

• A real-world case study demonstrating where AI has tangibly reduced costs or accelerated timelines
• How AI was implemented in practice (e.g. patient recruitment, data cleaning, site selection) and what made it successful
• Breaking down the ROI: cost savings, efficiency gains, and operational impact
• Lessons learned: where AI delivered value vs where it fell short—and how to replicate success in smaller biotech settings

There are many aspects to moving from early research to clinical delivery under one roof. This session explores the practical realities of building clinical operations and establishing an in-house Phase II unit.

• Building and scaling a clinical operations function
• Talent, structure, and service provider strategy
• Establishing an in-house Phase II unit: key considerations and patient recruitment

• The surge of high-quality assets from China: what’s driving the acceleration?
• Licensing trends: why Western pharma is increasingly looking East
• Regulatory implications: how the FDA and global bodies are adapting
• Geopolitics vs innovation: balancing risk, access, and opportunity in trial strategy

China’s life sciences sector is rapidly reshaping the global biotech landscape, with a growing pipeline of high-quality assets attracting significant international investment and licensing activity. This session will explore how this shift is impacting clinical development strategies, regulatory frameworks, and competitive dynamics. From navigating cross-border partnerships to understanding evolving FDA perspectives, join industry leaders as they unpack what this means for outsourcing, trial design, and the future of global collaboration.

Biotech companies often operate with lean teams and limited resources yet face the same complexities as larger pharma. This session will explore how smaller organisations can maximise internal capabilities, leverage cross-functional talent, and build efficient operating models to successfully deliver clinical trials.

• Making the most of lean teams: prioritisation and resource allocation strategies
• Leveraging cross-functional talent and transferable skillsets across departments
• Building agile operating models to increase efficiency and speed
• When to outsource vs keep capabilities in-house
• Empowering individuals to take on broader roles and responsibilities
• Creating a culture of collaboration and flexibility to drive delivery