- Understanding the link between European competitiveness, trial attractiveness, and patient access
- Examining how site capacity constraints are reshaping the clinical trial landscape
- Exploring what differentiates sponsors that sites and patients actively choose to work with
- Assessing how trusted partnerships can accelerate study delivery and bring innovation to patients faster
Archives: Agenda
Avoiding Turbulence: How Early and Proactive Patient Engagement Keeps Clinical Development on Course
- Understand why early patient engagement matters: Explore how patient-focused clinical development can improve the relevance, feasibility and quality of clinical trials.
- Explore the evidence and recommendations of meaningful PRP involvement: Review the 2023 EULAR recommendations and value of involving PRPs from the outset of clinical development.
- Consider how to put patient partnership into practice: Examine practical approaches to embedding PRP involvement in trial design, delivery and evaluation
Chairperson’s opening remarks
Chair: Available
KEYNOTE: Challenges and Opportunities for Biotech Clinical Drug Development
- How should clinical trial sponsors allocate resources to accelerate clinical development without compromising quality?
- Making strategic investment decisions across people, technology and quality
- Deciding where to build internal capabilities versus leveraging external partners
- Balancing speed, quality and capital efficiency while preparing for the next stage of growth
From Trial to Real World: Strategic Clinical Development Beyond Traditional CRO Models – Rethinking Partnership Models to Move from Trial to Real-World Impact
- Closing the Gap Between Trial and Impact: Translating clinical evidence into real-world outcomes: ensuring data supports access, reimbursement decisions, and ultimately, better lives for patients.
- Embedding Real-World Evidence from Day One: How strategic partnerships enable early RWE planning
- Redefining Partnership: Moving from vendor relationships to true collaboration
- Why Rare Diseases Are Different: The case for deeper Sponsor–CRO integration: navigating small patient populations, accelerating site activation and enrollment
Session reserved for Flex Databases
Afternoon refreshments, networking and prize draw
The Clinical Development Paradox: Trial Timelines Are Becoming Increasingly Rigid, But Trial Complexity Keeps Growing
- Why faster development timelines are colliding with increasing trial complexity
- Understanding how accelerated pathways are reshaping expectations across sponsors, CROs and regulators
- Assessing whether traditional operating and outsourcing models can keep pace with today’s demands
- Adapting to rolling submissions, real-time oversight and compressed development timelines
- Building operational resilience without compromising speed, quality or compliance
LIVE DEBATE Data Hoarding or Data Sharing? Rethinking Collaboration in Clinical Research
- Exploring the untapped potential of data sitting across academic centres, hospitals, sponsors, and research networks
- Debating whether competitive advantage is preventing the industry from unlocking faster and more cost-effective innovation
- Examining the operational, ethical, and commercial challenges associated with large-scale data sharing initiatives
- Discussing whether cross-industry consortia could create shared value, reduce duplication, and accelerate clinical development for all stakeholders
Debater 1: Eric Hajjar, Project Lead – Serious Bacterial Infections, Global Antibiotic R&D Partnership (GARDP)
Debater 2: Andreas Panteli, Director, Clinical Trial Recruitment/ Operations, Novartis
Moderator: Karen Cheng, Patient Advocate, The Myositis Association (TMA)