Archives: Agenda

• How Eikon is deploying AI today across vendor oversight, demand planning, compliance documentation and stakeholder communication
• Separating Real-World Value from the Hype: Discover what worked, what failed, and what the team would do differently, gaining a grounded perspective on where AI delivers genuine ROI versus where it falls short
• Learn how practical AI tools are uncovering hidden logistics risks and driving operational efficiencies in ways traditional supply chain software simply cannot match

• Addressing logistical challenges in clinical trials for blood sample processing.
• Implementing solutions to stabilize biomarkers at collection and simplify workflows.

• Evaluating CRO capabilities and experience relevant to your specific therapeutic area and development stage
• Balancing cost, quality and timelines within tight budget constraints
• Negotiating contracts with flexibility to protect your biotech’s goals

This session will explore whether the FDA’s Real-Time Clinical Trials (RTCT) program is an aspirational vision for the future or a near-term reality that biotech companies should begin preparing for today. This session will discuss what sponsors can do now to position themselves for participation in this emerging real-time development model.

• Separate hype from reality: Examine FDA’s stated goals for RTCTs, the scope of the pilot program, and its potential opportunities and limitations.
• Understand the broad operational and technology requirements: Identify the critical capabilities needed for participation in the pilot program.
• Develop your biotech readiness roadmap: Discuss practical actions sponsors can take today to assess their organizational readiness and engage with FDA as the RTCT model evolves.

• What “real time” looked like from the sponsor side when site activity became visible only after the work was complete
• How late queries and accessioning delays slowed data readout in a Phase I oncology study
• What changed when issues were identified and corrected before shipment
• Why clinical trial execution is foundational to better data and AI-ready trials