Archives: Agenda

The cards are already on the table. The question is whether Europe knows how to play them. This session explores how the EU can turn global uncertainty into a defining moment for clinical research, manufacturing and R&D leadership.

• Closing the gap with the USA and China: accelerating decision timelines, unlocking translational funding and giving NCA alignment real teeth across all 27 member states.
• Turning US instability into EU opportunity: how NIH cuts, FDA uncertainty and policy unpredictability are opening a window for EU-first trial strategies and how long it may stay open.
• Making regulatory alignment stick: from ICH harmonization to more effective collaboration building a system where alignment is enforced, not just encouraged.

This session will cover:

• What the data reveal about EU’s competitive position
• EU CTR: momentum gained, limitations encountered, and unintended consequences
• Beyond CTR: how IVDR and MDR are reshaping clinical research delivery
• What must change for EU to remain attractive, including initiatives shaping the future EU landscape (FAST‑EU, COMBINE, EU Biotech Act)

• Overview of outsourcing models: Full-Service Outsourcing (FSO), Functional Service Provider (FSP), and in-house
• Pros and cons of each model and how to select the best fit for your trial
• When hybrid approaches (mixing outsourcing and in-house) are more effective than fully outsourcing or keeping trials fully internal
• Understanding why FSP is gaining popularity among sponsors and how it can help meet trial timelines

• Empirical Data quantifying the magnitude of the problem
• Identification of Opportunities to optimise protocol design and improve clinical trial performance
• Case examples of strategies and their impact

• Opportunities most resonating within panel member companies
• Strategies and tactics to address these opportunities
• Implementation challenges and how to overcome them
• Areas of future focus and opportunity

Moderator: Ken Getz, Executive Director, Research Professor (PHCM), Tufts Center for the Study of Drug Development

Harnessing the convergence of high-fidelity data with advanced AI is now essential for de-risking clinical trials and accelerating therapies to patients. What if the distance between a draft protocol and a validated study execution plan was reduced to a single, unified simulation?

Join Medidata’s Rob Buka for a deep dive into the future of holistic trial design and planning. Learn how advanced modeling and simulation capabilities within a central workspace can revolutionize trial operations. This session will illustrate Medidata’s strategy for optimizing protocol design, predicting trial outcomes, and achieving greater clinical and operational success in the next generation of drug development.