Archives: Agenda

• 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make it difficult to identify emerging safety signals, a challenge recognized by both IDMC members and the FDA’s 2024 draft guidance.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
• Creating transparency around planning assumptions and defining decision-making authority within governance boards
• 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!

• 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

• The black box between scientific intent and clinical operations: Are our well-crafted protocols resting on a fragile chain of human actions?
• Four operational pitfalls at the site level: Where does trial execution break down?
• The trap of feeding black box data into AI: Are we simply accelerating the interpretation of bad execution data?
• Questions to ask your vendors about opening the execution black box

• Understanding the evolving regulatory landscape for AI-enabled trials
• Preparing for audits and inspections to avoid compliance pitfalls
• Lessons learned from real-world AI adoption across sponsors and CROs
• Implementing responsible AI practices to accelerate innovation without regulatory risk

• Responsible AI and Governance: Establishing practical frameworks for AI adoption, data privacy, and oversight in clinical research
• Site selection and start-up challenges: Lessons learned from initiating early-phase global clinical studies and overcoming common operational bottlenecks
• Smarter resourcing strategies: Balancing lean teams, CRO oversight, and cross-functional priorities to maximize productivity without compromising quality

A market-strategy read on why connectivity is the precondition, and AI is only the layer on top

• The tax that lean teams can’t absorb: Why 20+ disconnected site systems quietly cost small biotechs days, dollars, and audit findings
• You don’t need more people, just fewer gaps: How one cancer center cut protocol-training time in half and slashed monitoring findings 86% by connecting a single workflow
• Why connectivity beats a rushed AI bet: The case for fixing your execution layer before you buy the agentic-AI story