Archives: Agenda

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

Clinical Supply Practices in MRCT MRCT 中的临床供应实践

  • Regulatory Compliance: Navigating strict NMPA oversight and IP-GMP rules for MRCT integration.
  • Sourcing Strategy: Utilizing local procurement and bonded zones to bypass customs delays.
  • Labeling Standards: Implementing mandatory Simplified Chinese text while maintaining blinding integrity.
  • Domestic Logistics: Managing secure cold-chain distribution networks across vast hospital networks.
  • Chain of Custody: Executing meticulous drug reconciliation leading to certified local destruction.

 

  • 法规合规：应对 NMPA 严格监管以及 MRCT 整合中的 IP-GMP 规则。
  • 采购策略：利用本地采购和保税区政策避免清关延误。
  • 标签标准：落实强制性简体中文文本要求，同时保持盲法完整性。
  • 国内物流：在广泛的医院网络中管理安全的冷链配送网络。
  • 监管链：执行细致的药品核对，直至获得认证的本地销毁