Archives: Agenda

• The growing role of China in global clinical trials
• Key challenges facing clinical trial supply chains in China: logistics, regulations, and patient populations

• 中国在全球临床试验中日益凸显的核心地位
• 供应链三大核心挑战：
• 跨境物流与本土配送体系
• 动态监管合规要求
• 特殊患者群体的供应保障

• Sourcing comparators and placebos in China: Ensuring supply, regulatory compliance, and cost-effectiveness
• Addressing supply chain challenges specific to comparator and placebo sourcing
• Partnering with local vendors for sourcing in compliance with regulatory standards
• Efficiently managing comparator sourcing in a multi-country trial

• 中国本土供应体系构建：确保可及性、合规性与成本效益
• 对照药供应链特殊挑战应对方案
• 符合监管标准的本土供应商合作机制
• 跨国多中心试验中的高效供应管理

• 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

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

• 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

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

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

• The Rise of China’s Biotech Industry: The Chinese government’s “Made in China 2025” strategy and its impact on biotech innovation
• The role of China’s National Medical Products Administration (NMPA) in accelerating drug approvals
• The Role of Venture Capital in China’s Biotech Boom; How Chinese VCs and state-backed funds are fueling biotech startups and the differences between U.S. and Chinese biotech funding models
• Competitive Pressure on U.S. Biotech Firms
• Regulatory & Geopolitical Challenges: The impact of U.S.-China trade tensions and export controls on biotech collaboration

Moderator:

Claire Qin, Chief Strategy Officer, Intelligen AI; BioPharma Investor

中国生物科技产业迅猛发展，在药物研发、临床试验及全球市场拓展方面对美国生物科技企业构成日益激烈的竞争。凭借政府强力支持、资本优势及创新疗法管线的持续扩充，在风险投资（VC）加持下的中国生物科技企业正在重塑行业格局。本环节将深入分析竞争态势、美国企业面临的挑战以及全球生物科技创新的未来走向。

• 中国生物科技产业崛起：”中国制造2025″战略对生物科技创新的推动效应
• 监管加速作用：中国国家药品监督管理局（NMPA）在新药审批中的角色演进
• 资本驱动力量：中美国际资本运作模式差异——中国风险投资与政府基金如何赋能生物科技初创企业
• 美国企业的竞争压力：核心技术与市场份额的双重挑战
• 监管与地缘政治因素：中美贸易摩擦及出口管制对生物科技合作的影响

主持嘉宾:
秦祯，首席战略官，Intelligen AI