Archives: Agenda

（请至少参观3个展位）

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。

Patient enrollment remains one of the most critical bottlenecks in global drug development, often delaying timelines, increasing costs, and limiting patient access to innovative therapies. Against this backdrop, China has emerged not merely as a region of vast patient numbers, but as a laboratory for systemic innovation in clinical trial execution. 患者入组仍是全球药物开发中最关键的瓶颈之一，常常导致时间线延误、成本上涨，而且还会限制患者获得创新疗法的机会。在这一背景下，中国利用其庞大的患者数量而，不断发展临床试验执行中的体系创新。

• How China Building Beyond “Population Advantage”
• How to Leverage AI and Digital Platforms in Patient Matching
• The Power of Hospital Alliances and Regional Clinical Hubs
• Aligning Patient Recruitment, Clinical Supply Strategy And Site Readiness To Reduce Delays
• How to Adapt China’s Model for International Multi-Center Trials

• 中国不仅是“人口优势”
• 如何利用 AI 与数字平台进行患者匹配
• 医院联盟与区域临床中心的发展
• 患者招募、临床供应策略的动态调整
• 如何将中国模式应用于MRCT

Moderator: Sarah Nightingale, APAC Principal Consultant, GlobalData

China stands at an inflection point in global biopharma innovation. Having mastered the art of rapid development and commercialization as a fast-follower, the industry is now making a decisive strategic pivot towards becoming a true globald innovator. The rise of China-led international multi-center trials (MRCTs) and landmark global partnerships underscores a new reality: China is no longer just a vast market or a development executor, but a primary source of scientific insight and therapeutic value.

中国正处于全球生物医药创新的关键转折点。随着中国临床的蓬勃发展，现在已经逐渐引领全球创新。由中国主导的多中心临床试验（MRCT）以及具有里程碑意义的全球交易，正在展示着中国在临床试验中的角色转变——从全球申办方的执行中心，转变为科学前沿与医药创新的重要源头

• From “Fast Follower” to Autonomous Innovation
• Leveraging China’s Capabilities for Worldwide Development
• From Local Assurance to Global Collaboration
• Aligning Standards and Achieving Mutual Recognition
• Building an Open, Collaborative Global Network

• 从“快速跟随”到自主创新
• 借助中国能力推动全球开发
• 从本土保障到全球协作
• 标准统一与互认
• 建立开放、协作的全球网络

• Exploring the capability of Digital Display Labels (DDLs) and the benefits for Clinical Trial Supplies
• A demonstration of the functionality of DDLs; just in time labelling, lot & expiry update, multiple page count.
• Understanding the operational ability to securely & remotely update content & language.
• Integrating across IMP profiles, vials, bottles, blisters

• 探究数字显示标签（DDLs）的技术能力及其对临床试验供应带来的效益
• 现场演示数字显示标签（DDLs）的功能：实时/即时标签贴签、批号与有效期更新、多页面内容切换
• 深入了解其运营能力：如何安全地进行远程内容及语言更新
• 实现全方位集成整合：涵盖试验用药品（IMP）构型、西林瓶、药瓶及铝箔水泡眼包装（泡罩包装）

• Globalizing Early-Phase Development: Explores expanding opportunities for biopharmaceutical innovators to run Phase 1 trials internationally.
• Strategic Regional Advantages: Showcases destinations like Australia that offer rapid regulatory pathways, cost efficiencies, and universally accepted data.
• Operational Optimization: Uses case studies to highlight strategies for accelerating timelines, optimizing study designs, and reducing costs.
• Commercial Success: Illustrates how multi-region early-phase data drives robust partnering, licensing, and subsequent clinical success.
• 早期开发全球化： 探讨生物医药创新企业在国际上开展一期（Phase 1）临床试验的拓展机遇。
• 区域战略优势： 展示澳大利亚等基地的独特优势，包括快速的监管审批通道、高性价比以及全球通用的临床数据。
• 运营层面优化： 运用案例分析，重点阐述加速项目时间线、优化试验设计以及降低成本的有效策略。
• 商业成功助力： 阐明多区域早期临床数据的融合如何强力推动商务合作、品种授权以及后续临床研究的成功。

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。

Forcing a single clinical supply model across APAC creates delays, costs, and regulatory risks. This presentation addresses regional complexities through flexible strategies and local collaboration.

• Model Selection: Evaluating central, regional, and hybrid supply frameworks.
• Streamlined Logistics: Bridging gaps between sourcing, compliance, and local distribution.
• Risk Mitigation: Overcoming cross-border bottlenecks and critical documentation challenges.
• Strategic Value: Balancing speed, cost, and long-term partner alignment over transactional relationships.

在亚太地区强推单一的临床供应链模型会导致延误、高昂成本和合规风险。本演讲将通过灵活的战略与本地化合作，探讨并解决这些区域复杂性问题。

• 模式选择：评估集中式、区域式以及混合式的供应链架构。
• 高效物流：消除采购、合规与本地分销之间的断层。
• 风险缓解：克服跨境瓶颈与关键文件审查带来的挑战。
• 战略价值：权衡速度与成本，建立长期的伙伴协作，而非单纯的业务交易