Archives: Agenda

• Why recruitment forecasts and feasibility assessments across the DACH region continue to miss targets despite strong research infrastructure and healthcare systems
• How increasing study competition, protocol complexity, and limited patient availability are placing growing pressure on sites
• The operational challenges impacting recruitment and patient access across the region
• How sponsors, CROs, and sites can work together to create more realistic feasibility strategies and more sustainable approaches to patient recruitment and site engagement

Moderator: Karen Cheng, Patient Advocate, The Myositis Association (TMA)

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• Reducing development costs through leaner clinical strategies
• Navigating evolving regulatory expectations for biosimilars in Europe and globally
• Understanding how outsourcing models differ for biosimilar programs versus innovative therapies

• 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