Archives: Agenda

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

This presentation systematically addresses the core challenges and efficient execution strategies of supply chain management for MRCTs. It delivers practical management frameworks and partner selection methodologies for clinical operations and supply chain managers to improve trials’ overall execution quality and speed. 本演讲将系统性地阐述多区域临床试验（MRCTs）中供应链管理的核心挑战与高效执行策略。演讲将为临床运营与供应链经理提供实用的管理框架以及合作伙伴选择方法论，以全面提升临床试验的执行质量与速度。

• 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

As more Chinese biotech companies expand clinical development beyond China, the question is no longer whether to go global, but how to build globally ready development programs from the outset. Drawing on practical experience and industry observations, this presentation will explore the critical decisions sponsors face across development planning, regulatory strategy, study execution, and operational readiness. It will also share common challenges, lessons learned, and practical considerations to help organizations better prepare for clinical development across the US, Europe, and other international markets.

随着越来越多中国创新药企业加速国际化布局，当前面临的关键问题已不再是是否走向全球，而是如何从研发早期建立符合全球要求的临床开发策略。本次分享将结合实践经验与行业观察，探讨企业在全球临床开发过程中面临的关键决策，包括开发规划、注册策略、研究执行及运营准备等内容，并分享常见挑战、实践经验和可借鉴的建议，帮助企业更好地规划美国、欧洲及其他国际市场的临床开发。