Archives: Agenda

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

PANEL DISCUSSION: Staying Ahead of the Curve: Key Trends Transforming Clinical Trials 圆桌讨论：保持领先：重塑临床试验的关键趋势

Clinical development is being reshaped by technology, new regulations, and a patient=centric focus. This panel will analyse key trends, from virtual trials to AI, separating hype from reality and providing a practical roadmap for leading the next generation of clinical research.

临床开发正在受到技术、新法规和以患者为中心理念的重塑。本圆桌将分析从虚拟试验到 AI 的关键趋势，区分炒作与现实，并为引领下一代临床研究提供实用路线图。

  • Practical Implementation of DCTs & Hybrid Models
  • Integrating RWE, AI, and Advanced Analytics
  • Evolving from Recruitment to True Engagement
  • Adapting SOPs, Vendor Partnerships, and Risk Management
  • Regional Variations in Adopting Next-Generation Trials

 

  • DCT 与混合模式的实践落地
  • 整合 RWE、AI 与高级分析
  • 从患者招募迈向真正的患者参与
  • 调整 SOP、供应商伙伴关系与风险管理
  • 下一代试验在不同区域的采用差异

Managing Complex Logistics for ADC and Bi-Specific Antibody Clinical Trials ADC 与双特异性抗体临床试验的复杂物流管理

Antibody-Drug Conjugates (ADCs) and Bi-Specific Antibodies (BsAbs) represent the cutting edge of targeted oncology therapeutics. The delicate balance of the ADC structure (linker, antibody, payload) and the intricate assembly of the BsAb (two distinct binding domains) impose unprecedented demands for coordination and control across every logistical step, from manufacturing to the patient’s bedside.
抗体偶联药物（ADC）和双特异性抗体（BsAb）代表了靶向肿瘤治疗的前沿。ADC 结构（连接子、抗体、载荷）的精密平衡，以及 BsAb（两个不同结合结构域）的复杂组装，对从产线到病床的每一个物流环节都提出了前所未有的挑战。

  • Identifying Critical Vulnerabilities in ADC & BsAb Supply Chains
  • Strategies from Point-of-Manufacture to Global Distribution
  • How to Leverage IoT and Blockchain for End-to-End Traceability from Factory to Bedside
  • Dynamic Strategies for Dose Escalation & Biomarker-Driven Patient Stratification
  • Leveraging China’s Mature Biologics Supply Chain Ecosystem
  • 识别 ADC 与 BsAb 供应链中的关键节点
  • 从生产端到全球配送的策略
  • 如何利用 IoT 与区块链实现从产线到病床的端到端可追溯性
  • 剂量递增与生物标志物驱动患者分层的动态策略
  • 借力中国成熟的生物制品供应链生态