Archives: Agenda

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

• Understanding country-specific site application and approval requirements
• Reducing start-up timelines through effective planning and local partnerships
• Common challenges and pitfalls when activating sites across multiple regions
• Best practices for successful collaboration with investigators, sites, and regulators

• 了解各国特定的中心申请与审批要求。
• 通过有效规划和本地合作伙伴关系缩短启动时间。
• 跨多个区域启动中心时常见的挑战和陷阱。
• 与研究者、中心和监管方成功协作的最佳实践

Expanding clinical trials into China requires more than a global strategy, it requires local execution. In this session, Emsere will share how a smarter equipment rental and management strategy can simplify clinical trial operations, reduce logistical complexity, and ensure equipment is available when and where it’s needed. Learn how combining global standards with local expertise helps sponsors execute successful clinical trials in China. 将临床试验拓展至中国，不仅需要具备全球化的战略眼光，更需要扎实的本土化执行力。在本次专题中，Emsere 将分享如何通过更智慧的设备租赁与管理策略来简化临床试验运营、降低物流复杂度，并确保设备能够在所需的时间和地点精准交付。您将了解到，如何将全球统一标准与本土专业经验相结合，从而助力申办方在中国成功执行临床试验。