Archives: Agenda

• How should sponsors allocate resources to accelerate clinical development without compromising quality: Deciding where to build internal capabilities versus leveraging external partners
• Making strategic decisions across processes, technology and quality
• Outsourcing: Which model and when the solution must change
• Convincing the investor: Speed, quality and capital efficiency

• 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

• 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)

• 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

• Why most oncology trial delays are designed in before the first patient is enrolled
• How Pharma, Biotech and CRO teams are using AI to eliminate amendments before they happen
• What it takes to build a protocol that actually works operationally, globally, and regulator-ready from day one

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

• A definition of Europe’s competitive strengths and current role in global clinical development
• Determining recent challenges and competitive pressure
• Leveraging strategic success factors for future growth
• A joint outlook: How Europe can combine scientific excellence with greater speed and operational efficiency

• Integrating patient insights into decision-making from early development through to later stages of the medicines lifecycle
• Building meaningful partnerships with patients and patient organisations to shape development priorities and approaches
• Translating patient insights into practical changes to R&D processes, study plans and development strategies
• Evaluating how patient engagement influences the relevance of research, decision-making and development outcomes