Archives: Agenda

• Developing evidence generation strategies that align with regulatory expectations and clinical development goals
• Selecting meaningful clinical and patient-centred endpoints to support efficient trial design and execution
• Integrating innovative trial designs, biomarkers, and real-world evidence to strengthen development decisions
• Optimising endpoint strategies to reduce development risk, accelerate approvals, and improve trial outcomes

• Company overview and capabilities
• Formulation and process considerations by dosage form
• Common failure modes and mitigations by dosage form
• Case study overview
• Common causes of Phase I delays

• Embedding patients as equal partners across the medicines development lifecycle
• Building trust through education, transparency and collaborative decision-making
• Strengthening patient engagement to improve clinical research and regulatory decisions
• EUPATI case study: Practical examples of how meaningful patient involvement creates lasting impact

• Establishing robust AI governance frameworks that balance innovation with trust, transparency and regulatory compliance
• Identifying and mitigating risks associated with AI adoption across clinical development and healthcare
• Preparing for the next generation of autonomous AI systems while maintaining effective human oversight and accountability
• Exploring practical approaches to implementing responsible AI that meet evolving regulatory expectations

1 stage, a variety of rapid-fire opinions, bold predictions and myth-busting from experts across the industry. Audience members will vote, agree or disagree, on each hot take! There’ll be a chance for the audience to pose some questions to the panel too.

The panel will answer the following:

• Biggest challenge in clinical trials today
• Biggest recruitment mistake
• Regarding AI – What’s overhyped and what’s worth the hype
• Where programs fail most often
• What vendors misunderstand
• One thing pharma should start doing
• One prediction for 2030
• Hot takes from the audience

Moderator: Eric Hajjar, Project Lead – Serious Bacterial Infections, Global Antibiotic R&D Partnership (GARDP)

• Shifting Phase IV from an operational to a strategic function within broader evidence generation and lifecycle planning
• Building reusable evidence platforms rather than relying on fragmented, one-off studies
• Exploring the growing role of external control arms alongside the challenges of data quality and regulatory acceptance
• Selecting the right outsourcing model to support long-term evidence generation and the future evolution of Phase IV programmes

Old myths debunked and depicting a framework for developing a good outsourcing strategy

• Only words? Living with each party’s interest and building up strategies on a program level
• The tension between expectation and reality: Ethics, compliance, patient centricity with cost pressure and tight timelines
• Let’s put some industry myths to bed: 5 myths regarding outsourcing paradigms
• The building blocks of a successful outsourcing strategy: Thinking about an outsourcing architecture
• Let’s get this harvest in! Examples for efficiency and success
• An economic paradox? Growing complexity while maintaining costs?
• Take home message