Archives: Agenda

• Designing protocols with site and patient feasibility in mind to reduce complexity and accelerate recruitment.
• Embedding operational planning early to improve timelines, budget predictability, and study execution.
• Leveraging digital technologies, data, and AI to streamline trial management and reduce administrative burden.
• Building collaborative partnerships with sites, CROs, and technology providers to drive efficient, high-quality trial delivery

• 在方案设计阶段纳入中心和患者可行性考量，降低复杂度并加速招募。
• 尽早嵌入运营规划，以改善时间线、预算可预测性和研究执行。
• 利用数字技术、数据和 AI 简化试验管理并减少行政负担。
• 与中心、CRO 和技术供应商建立协作伙伴关系，推动高效、高质量的试验交付。

The rise of Cell and Gene Therapies presents a formidable supply chain challenge due to their nature as “living drugs.” Success in China’s CGT clinical trials thus hinges on mastering a complex, time-sensitive, and patient-centric logistical system to translate the immense potential of these therapies into reliable patient outcomes.
细胞与基因疗法的兴起为供应链带来了严峻挑战，因为其本质上属于“活体药物”。因此，中国 CGT 临床试验的成功取决于能否掌握复杂、时间敏感且以患者为中心的物流体系，将这些疗法的巨大潜力转化为可靠的患者结果。

• What is the Unique CGT Challenge
• Assessing China’s Readiness in Cryogenic Logistics, GMP Facilities & Single-Use Technologies
• Orchestrating the “Vein-to-Vein” Journey with Real-Time Tracking & Chain of Custody
• Navigating NMPA Guidelines and Building QMS for Advanced Therapies
• The Integrated Role of Specialized CDMOs, Logistics Providers & Clinical Sites

• CGT 的独特挑战是什么
• 评估中国在低温物流、GMP 设施和一次性技术方面的准备度
• 通过实时追踪和监管链管理“从静脉到静脉”的全流程
• 解读 NMPA 指南并为先进疗法建立 QMS
• 专业 CDMO、物流供应商与临床中心的一体化角色

• AI as Digital Workforce: Automating Clinical Operations and Intelligent Data Quality Control under ICH E6(R3)
• From Pain Points to Solutions: DCT Application & Landing Practice

• AI 作为数字化劳动力：在 ICH E6(R3) 框架下实现临床运营自动化与智能数据质量控制。
• 从痛点到解决方案：DCT 应用与落地实践。

Moderator: Suqin Xia, Founder, DCT Academy

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