This session outlines an end-to-end framework for Multi-Regional Clinical Trials (MRCTs). It covers critical regional epidemiology and regulatory planning, third-party operational models, the impact of inter-ethnicity differences on future labeling, and navigating health agency registration decisions.
Plan
- Clinical epidemiology in different regions
- Regulatory requirements on protocol design and patient recruitment
- Timeline and financial models
Do
- Operational models involving third parties
Check
- Influence of inter-ethnicity differences and response differences on future label statements
Access
- Agency‘s decision on registration
本演讲将全面概述多区域临床试验（MRCT）的端到端框架：涵盖区域流行病学与法规落地规划（Plan）、第三方运营模型构建（Do）、种族差异对未来说明书标签的影响评估（Check），以及应对监管机构注册决策的策略（Access）。
- How to build a “Predict and Prevent” Supply Mindset
- Dynamic Re-supply Models for a Dynamic Clinical Reality
- A Step-by-Step Guide to Smoother Cross-Border Movements
- Rapid Response Protocols and Effective Contingency Planning
- Integrating Partners into a Single, Seamless Team
- 如何建立“预测并预防”的供应思维。
- 面向动态临床现实的动态补货模型。
- 更顺畅跨境运输的分步指南。
- 快速响应流程与有效的应急规划。
- 将合作伙伴整合为一个无缝协作团队。
Moderator: Jae-Young Ha, CBO, AriBio
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
Chinese biotech is moving faster than ever from innovation to global ambition — but the challenge now goes beyond developing a differentiated asset. It’s proving that asset’s value early, generating globally credible clinical data, and reaching the right international partners before momentum fades. Drawing on real-world case studies, this session examines how delays at proof-of-concept erode value, how regulatory and operational efficiency compress development timelines, and how Chinese biotechs can expand globally without slowing execution. Attendees will gain practical insight into how faster PoC, stronger patient access, efficient global trial deployment, and high-quality international data strengthen partnering discussions and make assets more attractive to global pharma.
中国生物医药产业正以前所未有的速度从“本土创新”迈向“全球雄心”。然而，企业如今面临的挑战已不仅限于研发具有差异化的资产，更在于如何在早期证明资产价值、生成具备全球公信力的临床数据，并在市场热度消退前精准对接国际合作伙伴。本议程将结合真实世界案例研究，深入探讨概念验证（PoC）阶段的延迟如何侵蚀资产价值、如何通过提升监管与运营效率来压缩研发周期，以及中国药企如何在不牺牲执行速度的前提下实现全球化扩展。参会者将获得极具实用价值的行业洞察，明确如何通过加速PoC进程、强化患者招募、高效部署全球临床试验以及获取高质量国际数据，来增加商务谈判筹码，从而让管线资产对跨国药企（Global Pharma）更具吸引力。
