Archives: Agenda

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

• 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。

• 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