Many countries across the globe have enacted privacy laws and now Healthcare Authorities and Ethics Committees mandate that Clinical Trial Applications contain appropriate data privacy language. The good news is that it is simple in the Life Science industry because Good Clinical Practices have always protected the Rights of the Patients since the Code of Nuremberg in 1949. Participants will understand how to do it right the first time, they will learn the key points of attention, so the clinical trial is not delayed.
全球许多国家已颁布隐私法。目前，各国医疗卫生当局和伦理委员会均强制要求临床试验申请（CTA）中包含适当的数据隐私表述。值得庆幸的是，生命科学行业在此方面有深厚积累——自1949年《纽伦堡法典》问世以来，”临床试验规范“（GCP）就一直致力于保护患者权益。本演讲/课程将帮助参会者了解如何从源头实现合规的正确路径，并深度剖析关键风控点，以避免临床试验的延误。
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
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。
