Archives: Agenda

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。

• Embedding agility into study decision models to intelligently support decentralized and hybrid trial models.
• Creating connected DCT ecosystems to shorten study timelines and reduce overall operational burden.
• Leveraging AI-driven insights to optimize end-to-end patient support and long-term adherence.
• Intelligent Medication Management & Safety Monitoring with smart pillboxes to enable closed-loop medication adherence and safety surveillance.

• 将动态适应嵌入研究决策模型，智能支持去中心化和混合型试验模式。
• 打造互联的 DCT 生态系统，缩短研究周期并降低整体运营负担。
• 利用 AI 驱动洞察，优化端到端患者支持和长期依从性。
• 通过智能药盒实现智能用药管理与安全监测，形成闭环用药依从性和安全监测。

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

• Development of the biomedical industry in SIP
• Innovation ecosystem for biomedical industry in SIP
• 苏州工业园区（SIP）生物医药产业的发展历程与现状
• 苏州工业园区（SIP）生物医药产业的创新生态系统

China’s pharmaceutical innovation stands at a pivotal inflection point. After a decade of explosive growth, the industry is navigating a period of “capital winter,” intense policy-driven competition, and a strategic shift from the pursuit of quantity to the mandate of quality. However, this pressure is also a catalyst, forcing a clear-eyed re-evaluation of the path forward. Today, China is not just a vast clinical trial hub or a manufacturing powerhouse; it is defining its ambition to become a “world new drug creation center” by 2035.
中国医药创新正处在关键转折点。经历十年的爆发式增长后，行业经历了“资本寒冬”、政策驱动的激烈竞争，以及从追求数量转向强调质量的战略变化。在这种压力下，行业对未来发展有了更清醒的认识。现在，中国不再只是庞大的临床试验中心或制造强国；它正在定义到 2035 年成为“世界新药创制中心”的雄心。

• The “Innovation Pivot”: From Fast-Follower to First-in-Class
• The “Globalization 2.0” Playbook: From BD Transactions to Enduring Value
• The “Dual Engine” of Policy: Regulatory Acceleration Meets Payment Reformation
• Convergence and Concentration: Surviving the “Great Integration”
• The Ultimate Alignment: Bridging the Pipeline to Unmet Clinical Need

•  “创新转向”：从快速跟随到 First-in-Class
•  “全球化 2.0”打法：从 BD 交易到持久价值
•  政策“双引擎”：监管加速与支付改革并进
• 融合与集中：在“大整合”中生存
• 终极方案：将管线与未满足的临床需求相适配

Moderator: Sarah Nightingale, APAC Principal Consultant, GlobalData