Archives: Agenda

GlobalData’s clinical trials data indicates that new trials initiated in H1 2025 has increased significantly over previous years. In addition to surprising Wall Street, this has shaken up the biopharma competitive landscape and created major opportunities for CROs, CDMOs, Pharma Tech, and consultancies. Behind the headlines, clinical trial reporting lags, shifting start dates, and withdrawals make it easy to miss where the real growth is happening.

This session breaks down what drove the surge, where the next wave is coming from, and how early signals can give you the edge on predicting future market shifts. Whether you run trials, manufacture at scale, or advise life sciences companies, this is about being prepared, before your competitors are.

• Overview of the T-cell immunotherapy landscape
• Trends in regulatory approvals and designations impacting trial timing and logistics
• Market outlook and projected growth through 2031 and the implications for supply planning
• Clinical trial insights, including leading countries and key challenges affecting trial execution

• Planning modular PMPF studies to generate evidence supporting claim refinement, new use settings, or population expansion
• Addressing gaps from initial submissions and identifying operational challenges
• Leveraging AI tools to streamline post-market data collection, identifying emerging risks earlier, and improving interpretation of real-world performance
• Using PMPF outcomes to support intended purpose expansion and/or claim updates

• See how to align robust clinical evidence for MDR from an NB perspective
• Bridge the gap between reviewer expectations and sponsor realities
• Optimize clinical trial design and submissions for smoother approval

Chair: Dominic Tong, Senior Analyst, Medical Devices, GlobalData

• Medical device evidence is shifting from one-off trials to continuous, lifecycle-long evidence, with growing emphasis on post-market and real-world data and performance
• Episodic evidence generation models, designed around isolated studies and outsourced delivery, are increasingly misaligned with these expectations and introduce cost, delay and duplication at scale
• How medtech teams can use a single, versatile and affordable platform to run feasibility studies, trials, PMS and RWE in-house, enabling faster evidence generation and systematic reuse across the lifecycle
• A surgical robotics case study showing how clinical trial capabilities are brought in-house and a global clinical registry is leveraged to support evidence generation pre- and post-market

• Tracing the evolution of IVDR governance and how MDCG working groups shaped today’s framework and merged responsibilities over recent years
• Exploring behind the scenes of performance study assessments, including what is discussed within the competent authority review process and how applications are evaluated
• Sharing practical recommendations, common pitfalls, lessons learned, and strategies for preparing approval-ready submissions

• How an all-in-one eClinical platform simplifies medical device trial operations
• Why API-first interoperability is critical for device studies
• Practical AI use cases that support, rather than replace, clinical teams

• Understanding the updated competent authority application pathway for CDx under IVDR
• Sharing lessons learned from real-world submissions and post-application interactions
• Identifying best practices for aligning diagnostic and therapeutic regulatory timelines when engaging with authorities

• Spotting compliance risks early for novel or AI-enabled devices
• Best practices for bridging clinical and regulatory teams
• Lessons from recent reviews and practical recommendations for sponsors