Archives: Agenda

The Next-Generation DCT Blueprint: AI-powered Network and Study Design Agility 下一代 DCT 蓝图：AI 驱动的网络洞察与试验设计动态适应性

  • Embedding agility into study decision models to intelligently support decentralized and hybrid trial models.
  • Creating connected DCT ecosystems to shorten study timelines and reduce overall operational burden.
  • Leveraging AI-driven insights to optimize end-to-end patient support and long-term adherence.
  • Intelligent Medication Management & Safety Monitoring with smart pillboxes to enable closed-loop medication adherence and safety surveillance.

 

  • 将动态适应嵌入研究决策模型，智能支持去中心化和混合型试验模式。
  • 打造互联的 DCT 生态系统，缩短研究周期并降低整体运营负担。
  • 利用 AI 驱动洞察，优化端到端患者支持和长期依从性。
  • 通过智能药盒实现智能用药管理与安全监测，形成闭环用药依从性和安全监测。

WINNING GLOBAL OUT-LICENSING: STRATEGIES FOR INNOVATIVE CHINESE BIOTECHS赢在海外授权：中国创新药企的全球化策略

Chinese biotech is moving faster than ever from innovation to global ambition — but the challenge now goes beyond developing a differentiated asset. It’s proving that asset’s value early, generating globally credible clinical data, and reaching the right international partners before momentum fades. Drawing on real-world case studies, this session examines how delays at proof-of-concept erode value, how regulatory and operational efficiency compress development timelines, and how Chinese biotechs can expand globally without slowing execution. Attendees will gain practical insight into how faster PoC, stronger patient access, efficient global trial deployment, and high-quality international data strengthen partnering discussions and make assets more attractive to global pharma.

中国生物医药产业正以前所未有的速度从“本土创新”迈向“全球雄心”。然而，企业如今面临的挑战已不仅限于研发具有差异化的资产，更在于如何在早期证明资产价值、生成具备全球公信力的临床数据，并在市场热度消退前精准对接国际合作伙伴。本议程将结合真实世界案例研究，深入探讨概念验证（PoC）阶段的延迟如何侵蚀资产价值、如何通过提升监管与运营效率来压缩研发周期，以及中国药企如何在不牺牲执行速度的前提下实现全球化扩展。参会者将获得极具实用价值的行业洞察，明确如何通过加速PoC进程、强化患者招募、高效部署全球临床试验以及获取高质量国际数据，来增加商务谈判筹码，从而让管线资产对跨国药企（Global Pharma）更具吸引力。

OPENING KEYNOTE: China’s Biopharma Leap: From Fast-Follower to Global Innovator 开幕主题演讲：中国生物医药的跃升：从快速跟随到引领创新

China stands at an inflection point in global biopharma innovation. Having mastered the art of rapid development and commercialization as a fast-follower, the industry is now making a decisive strategic pivot towards becoming a true globald innovator. The rise of China-led international multi-center trials (MRCTs) and landmark global partnerships underscores a new reality: China is no longer just a vast market or a development executor, but a primary source of scientific insight and therapeutic value.

中国正处于全球生物医药创新的关键转折点。随着中国临床的蓬勃发展，现在已经逐渐引领全球创新。由中国主导的多中心临床试验（MRCT）以及具有里程碑意义的全球交易，正在展示着中国在临床试验中的角色转变——从全球申办方的执行中心，转变为科学前沿与医药创新的重要源头

  • From “Fast Follower” to Autonomous Innovation
  • Leveraging China’s Capabilities for Worldwide Development
  • From Local Assurance to Global Collaboration
  • Aligning Standards and Achieving Mutual Recognition
  • Building an Open, Collaborative Global Network
  • 从“快速跟随”到自主创新
  • 借助中国能力推动全球开发
  • 从本土保障到全球协作
  • 标准统一与互认
  • 建立开放、协作的全球网络

How biotech companies can build operational excellence into trials from the outset 打造卓越的临床方案设计

  • 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。

Supply Chain Readiness for Cell and Gene Therapy Trials in China 中国CGT供应链实践

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

PANEL DISCUSSION AI & DCT: Transforming Clinical Trial Delivery in China 圆桌讨论：AI +DCT：重塑中国临床试验交付

  • 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

PEDIATRIC SPOTLIGHT – Interactive Session: Beyond the Blood Draw: Balancing Scientific Ambition and Patient Burden in Pediatric Trials

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