Archives: Agenda

• AI integration across the drug development lifecycle
• Building AI-driven drug discovery pipelines in China
• Overcoming challenges in AI adoption
• Success case study from Degron

中国正快速将人工智能（AI）整合到药物研发和临床开发中，这得益于机器学习、大数据分析的进步以及政府对生物技术创新的支持。本环节将聚焦AI从早期发现到监管申报的实际应用，并探讨企业如何在不断变化的中国监管环境中成功利用AI技术。

• AI在药物研发全生命周期中的整合
• 构建AI驱动的中国药物研发管线
• AI技术落地面临的挑战与应对
• 达歌生物成功案例分享

• Site selection strategies and patient recruitment challenges
• Decentralized trials and remote monitoring in China
• Risk management and quality control in outsourced trials

• 研究中心筛选策略与患者招募挑战
• 中国本土去中心化临床试验与远程监查实践
• 外包试验中的风险管理与质量控制

• Quickly generate initial efficacy signals – PROOF of CONCEPT – with globally recognized FDA/EMA
• Secure expedited regulatory approval for Phase 1 and 2 clinical trials in
• Achieve an efficient budget for clinical

• 快速生成具有全球认可度（FDA/EMA 标准）的初步疗效信号 – 概念验证
• 确保在欧洲获得加速的一期和二期临床试验监管审批
• 实现临床试验预算的高效配置

The Evolving Clinical Trial Landscape in China: Challenges & Opportunities

China has emerged as a key player in global clinical research, driven by regulatory reforms, a vast patient population, and increasing investments in biotechnology. This panel discussion will provide a comprehensive overview of the current clinical trial landscape in China, examining the challenges, opportunities, and future outlook for sponsors, CROs, and global stakeholders.

• Current State of Clinical Trials in China

Growth trends and recent developments in the Chinese clinical trial ecosystem, impact of regulatory reforms, including NMPA’s efforts to streamline approvals, China’s role in global multi-regional clinical trials (MRCTs).

• Challenges Facing Clinical Trials in China

Navigating regulatory complexities, Intellectual property (IP) concerns and data protection in clinical research, Operational challenges: site selection, patient recruitment, and investigator training, Differences in trial execution compared to the U.S. and EU.

• Clinical Trial Supply Chain

Challenges and Best Practice; Strategies for reducing supply chain disruptions and ensuring compliance

• Opportunities for Sponsors & CROs

• The Future of Clinical Trials in China

How China is positioning itself as a leader in global drug development. Potential impact of geopolitical factors on international collaboration.

Moderator:

Fiona Barry, Editor in Chief & Director of Outsourcing, Globaldata Healthcare

Panelists:

Summer Xia, CEO & Founder, Trial-Data Medicine Li Zeng, CEO, Jing Medicine

Fiona Xing, Senior Director of Global Clinical Trial Supply, Brii Biosciences

中国临床试验格局的演变：挑战与机遇

中国凭借监管改革、庞大的患者群体及对生物技术日益增长的投资，已成为全球临床研究的关键参与者。本论坛将全面剖析中国临床试验的现状，探讨申办方、CRO 及全球利益相关方面临的挑战、机遇与未来

• 中国临床试验现状：中国临床试验生态系统的增长趋势与最新进展；监管改革的影响（包括 NMPA 审批流程优化举措）；中国在全球多区域临床试验（MRCT）中的角色
• 中国临床试验面临的挑战：复杂监管环境的应对策略；知识产权保护与临床研究数据安全；实操难点：研究中心筛选、患者招募及研究者培训；中美欧临床试验执行的差异性分析
• 临床试验供应链：挑战与最佳实践
• 降低供应链中断风险与合规保障策略
• 赞助商与 CRO 的机遇
• 中国临床试验的未来图景：中国如何确立全球药物研发领导地位；地缘政治因素对国际合作潜在影响

主持嘉宾:

Fiona Barry, 医疗健康部主席，GlobalData

论坛嘉宾:

夏素琴，创始人，创达医药曾雳，创始人，和径医药

邢新苗, 供应链高级总监，腾盛博药

• Working with Chinese CROs and CMOs – what global sponsors should
• Common difficulties for China sponsors going
• Managing cross-border clinical trials: logistics, communication, and cultural
• Case studies of successful global-China

• 与中国 CRO/CMO 合作——全球申办方必备指南
• 中国出海常见难点
• 跨国临床试验管理要点：物流协调、沟通机制与文化适配
• 中外合作成功案例深度解析

• Case Studies on the Overseas Expansion of Chinese Medical Devices.
• Exploring the Global Medical Device Market: Where to Set Sail First?
• Practical Insights and Considerations for Multinational Clinical Trials.

• 中国医疗器械出海案例分享
• 全球医疗器械市场探索：出海第一站在哪？
• 跨国临床试验实战与注意点