Archives: Agenda

• Strategies for embedding AI tools into everyday workflows and gaining buy-in across cross-functional teams
• Practical lessons for small biotech companies transitioning from experimentation to enterprise-level AI capabilities
• Why data quality, governance, and integrated systems must be established before AI can deliver meaningful insights
• Identifying realistic use cases where AI can support decision-making, forecasting, and operational oversight in drug development

• The Premise: Evolution, Not Replacement
• Current State: AI Use-Cases on the Ground
• Future State: The “Last-Mile” of Drug Development
• Builders, Not Bystanders: Why We Must Drive AI Development

• Traditional IDMC reports are struggling to keep pace with the complexity of modern clinical trials. Lengthy, table-heavy reports can make it difficult to identify emerging safety signals, a challenge recognized by both IDMC members and the FDA’s 2024 draft guidance.
• This presentation explores how modern data visualization techniques, including targeted graphical displays and interactive dashboards, can transform interim data into clear, actionable insights. By improving the interpretation of safety trends, patient trajectories and clinically relevant deviations, visualization enables faster signal detection and more informed IDMC decision-making.
• Attendees will discover practical strategies for modernizing IDMC reporting to improve patient safety, support regulatory expectations and enhance oversight throughout clinical development.

• Planning transitions between trial phases while maintaining clear governance and operational continuity for small biotechs as well as large pharma
• When does governance not happen when it should?
• Fit-for-purpose governance: Tailoring oversight strategies to the biotech environment, where agility and limited resources are critical
• Strengthening responsible vendor oversight with up-to-date documentation and compliance aligned with evolving ICH guidance and regulatory expectations

Moderator: Krissy Meckel Parker, Associate Director, Clinical QA, Neurocrine Biosciences

• Background and rationale for obtaining ethnic data in Phase I
• Case for collecting the data outside of China and Japan
• Regulatory updates from PMDA and NMPA
• Strategic planning. How, when and where to collect the data

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!

Sponsored by Dr. Vince Clinical Research

• Exploring the “flight to quality” as biopharma investment concentrates on high-potential therapeutic areas
• Examining today’s funding landscape and shifts in indication focus
• Moving from AI pilots to practical implementation across clinical research
• Highlighting emerging approaches and innovations reshaping trial delivery