Archives: Agenda

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: Rachel Wang王维新, Consultant顾问, Deallus

• Why Poland/CEE delivers: A proven early oncology environment — dense investigator networks, treatment-naive patients, and fast site activation built for FIH-to-Phase-II programs
• The regulatory pathway: What makes CEE data credible for FDA and EMA — and why country-level trial authorization in Europe is getting faster
• The case in practice: What early oncology development anchored in Poland/CEE looks like — and the operational set-up decisions that determine whether it delivers for your global filing

• 为什么波兰/中东欧可交付：成熟的早期肿瘤环境 – 密集的研究者网络、未接受治疗的患者群体，以及为 FIH 至 II 期项目打造的快速中心启动能力。
• 法规路径：是什么让中东欧数据获得 FDA 和 EMA 认可 – 以及为什么欧洲国家层面的临床试验授权正在加速。
• 实践案例：以波兰/中东欧为中心的早期肿瘤开发现状 – 哪些运营决策决定其能否服务全球申报。

Ensuring end-to-end quality standards is arguably the most significant operational challenge for sponsors and CDMOs alike. This complexity is heightened by the reality that a clinical supply network is a potential point of failure, risking not only product quality but the integrity of the entire trial.

确保端到端质量标准，可以说是申办方和 CDMO 面临的最重要运营挑战。由于临床供应网络中的任何环节都可能成为故障点，这一复杂性被进一步放大，不仅会影响产品质量，也会影响整个试验的完整性。

• Rethinking the Role of the Quality Unit
• Risk-Based Supplier Qualification and Lifecycle Management
• Digital Platforms for End-to-End Quality Data Integrity
• Managing Change in a Distributed Network
• Building a Culture of Quality Across Organizational Boundaries

• 重新定义质量部门
• 基于风险的供应商资质认定与生命周期管理
• 用于端到端质量数据完整性的数字平台
• 分布式网络中的变更管理
• 跨组织边界建立质量文化

• Embedding resilience into supply chain strategy, operations, and quality systems
• Leveraging digital technologies and data visibility to anticipate and mitigate disruptions
• Strengthening supplier networks and risk management frameworks for long-term continuity
• Balancing agility, compliance, and efficiency in an evolving global landscape

• 供应链战略、运营和质量体系的风险管控。
• 利用数字技术与数据可视化提前识别并缓解中断风险。
• 强化供应商网络与风险管理框架，保障弹性供应能力。
• 在不断演变的全球格局中平衡便利性、合规性和效率。

• Predicting enrollment trends to ensure uninterrupted clinical trial supply
• Using data-driven forecasting to support agile decision-making
• Managing uncertainty across global, multi-site studies
• Best practices for responding to faster-than-expected recruitment and changing demand

• 预测入组趋势，确保临床试验供应不中断。
• 使用数据驱动的预测支持快速决策。
• 管理全球多中心研究中的不确定性。
• 应对超预期快速招募和需求变化的最佳实践。

Moderator: Daniel Gao, President, ISPE Supply Chain

China has evolved from a participant in global clinical trials to a major driver of scientific innovation and drug development. As sponsors increasingly rely on China-generated data for global regulatory submissions, success requires more than adherence to international quality standards. This session explores how reliable clinical trial testing is achieved by combining globally harmonized quality systems with local scientific, operational, and regulatory expertise. Using examples from Eurofins Central Laboratory’s experience in China, including biomarker testing, method transfer, and HGRAC-aligned study execution, the session demonstrates how global standards and local excellence work together to deliver trusted, regulatory-ready data that accelerates clinical development worldwide.

中国已从全球临床试验的参与者，转变为科学创新与新药研发的核心驱动力。随着申办方日益依赖在中国生成的数据来进行全球监管申报，项目的成功不仅要求遵循国际质量标准，还需要更深层次的布局。本议题将探讨如何通过将全球统一的质量体系与本土的科学、运营及监管专业知识有机结合，来保障临床试验检测的可靠性。结合欧陆中央实验室（Eurofins Central Laboratory）在中国的丰富实践经验（包括生物标志物检测、方法转移以及符合人类遗传资源管理办公室/HGRAC要求的试验执行），本议题将深度展示全球标准与本土卓越实力的完美融合，从而如何交付值得信赖、符合监管要求的临床数据，最终加速全球新药研发进程。