Archives: Agenda

Participants work together in this collaborative session to separate genuine clinical value from AI hype, exploring where AI can meaningfully improve trial delivery and where human expertise remains essential

• 5-minute problem statement introducing a sponsor considering AI across multiple areas of clinical trial delivery
• 20-minute whiteboard exercise mapping where AI can add the most value across trial design, recruitment, operations, data and decision making
• 5-minute table presentations comparing each group’s learnings and approaches from the session 

Facilitator: Megan L. Dunham, Director, R&D AI Governance & Portfolio Strategy, Jazz Pharmaceuticals 

Co-Facilitator: Available for event sponsor

• Aligning early-stage packaging, labeling, and inventory models with future commercial market access requirements
• Identifying single-source dependencies, cold chain vulnerabilities, and regulatory bottlenecks before Phase III trials
• Selecting CDMO and logistics partners capable of seamlessly transitioning from small-batch clinical trials to full-scale commercial manufacturing

• Why recruitment forecasts and feasibility assessments across the DACH region continue to miss targets despite strong research infrastructure and healthcare systems
• How increasing study competition, protocol complexity, and limited patient availability are placing growing pressure on sites
• The operational challenges impacting recruitment and patient access across the region
• How sponsors, CROs, and sites can work together to create more realistic feasibility strategies and more sustainable approaches to patient recruitment and site engagement

Moderator: Available

Keaton Fonvielle is Head of Client Services at Atreo, where she leads client services strategy, project management, and operational delivery.  She brings more than 14 years of experience in RTSM across both CRO and technology organizations, with a background in project delivery, client leadership, team development, and operational transformation.  Keaton is particularly passionate about leveraging technology to make peoples’ lives better – creating positive experiences for clients, internal teams, and most importantly, patients.

• Understanding the key import compliance and documentation requirements when bringing products into the U.S.
• Navigating the different requirements that may apply depending on the product being imported
• Understanding the role of partner government agencies and when their requirements may come into play
• Knowing where to find the right guidance and which agencies or resources to turn to when questions arise