Archives: Agenda

Participants will learn how to evaluate and optimize pediatric biomarker sampling strategies, apply a practical blood volume review framework, identify opportunities to reduce patient burden while preserving scientific value, and explore future innovations that enable more insight from less blood.

Workshop objectives:

• Recognize the impact of blood volume burden in pediatric clinical trials
• Evaluate protocol sampling requirements through a patient-centered lens
• Apply strategic biomarker sampling principles to balance scientific objectives with patient feasibility and operational considerations
• Identify opportunities to reduce blood volume without compromising study objectives
• Explore emerging innovations in sample collection and biomarker science

In rare diseases, the eligible population may be a few hundred people scattered across a dozen countries, and many are already searching online for options long before they reach a study site. This session shows how sponsors can reach those patients directly, in their own language, and connect them to active sites ready to screen.

Adnexi will walk through its innovative Direct-to-Patient Enrollment Accelerator: compliant digital campaigns across 20 countries, IRB/EC-approved pre-screeners, and a referral portal that gives sites and sponsors visibility from first contact through randomization. Adnexi will then turn to it’s exhaustive global PAG platform, which identifies, profiles and engages patient advocacy groups in a specific disease state to augment enrollment.

Attendees will leave with a deep understanding of the latest innovations in patient enrollment for rare diseases.

• How to plan and allocate resources effectively across the full study lifecycle (from manufacturing to release and distribution)

• How to prepare for audits and inspections proactively incorporating audit readiness into daily workflows to avoid last minute firefighting

• The value of leveraging external partners and CDMOs effectively to improve quality oversight with limited internal teams

Prize Draw taking place in exhibition hall at 14:15

Join us for a chance to win one of our prizes, including Apple products

Prize Draw taking place in exhibition hall at 14:15

Join us for a chance to win one of our prizes, including Apple products

• Exploring realistic AI applications across forecasting, inventory management and distribution planning for Korean and regional trials
• Keeping pace with fast-moving AI development while maintaining trial integrity and regulatory alignment
• AI, data and the changing role of the CRO/vendor in Korea’s clinical supply ecosystem

• Moving beyond transactional oversight toward a genuine strategic partnership model
• Aligning financial incentives so both sponsor and CRO win when a trial performs well
• Leveraging joint innovation initiatives (AI, digital tools, process redesign) as a partnership accelerant rather than a point of friction
• Defining what “great” actually looks like from both the sponsor’s and the CRO’s perspective before trying to get there

• Overcoming the latest challenges in global cold chain logistics for clinical trials
• Identifying common risks and mitigation strategies for international temperature-controlled shipments
• Leveraging real-time temperature monitoring and digital technologies to enhance shipment visibility

• Assessing the existing clinical evidence and data gaps when taking on a licensed-in asset
• Translating the asset’s development strategy into an optimized clinical trial design
• Aligning internal teams, external partners, and investigators to accelerate study start-up and first-patient-in