Archives: Agenda

• 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。

• 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

Securing the right comparator drug is often the most critical yet daunting hurdle in planning a registration trial in China. Unlike other supplies, a comparator is not merely a commodity; it is a regulatory benchmark, a clinical necessity, and a potential bottleneck that can derail timelines and compromise data integrity.

• Strategies to ensure unbroken supply continuity.
• Risk mitigation plans for sourcing uncertainties.
• Practical insights from global pharmaceutical business.

在筹备中国注册临床试验的过程中，获取正确的对照药往往是最关键但也最棘手的难题。与其他临床供应品不同，对照药不仅仅是一种物资，它更是监管的基准、临床的必需品，也是一个极易导致项目延期并损害数据完整性的潜在瓶颈。

• 保障供应链持续不中断的应对策略
• 针对采购不确定性的风险缓解计划
• 来自全球制药企业的实用洞察

• Building Cross-Functional Leadership: Developing “T-shaped” talent with end-to-end operational vision.
• Proactive Risk Management: Systematically anticipating and mitigating clinical trial risks.
• Strategic Partnership with CROs: Redefining sponsor-CRO collaboration beyond transactional outsourcing.
• From Trial Data to Market Value: Making clinical quality the cornerstone of biotech IPO credibility.

• 构建跨职能领导力： 培养具备端到端（全流程）运营视野的“T型”复合型人才。
• 前瞻性风险管理： 系统性地预测并缓解临床试验过程中的潜在风险。
• 与 CRO 的战略合作伙伴关系： 重新定义申办方与 CRO 的合作模式，摆脱单纯的“交易型外包“。
• 从试验数据到市场价值： 让临床质量成为生物医药企业 IPO（上市）公信力的基石。

• 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。

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。

Moderator: Sarah Nightingale, APAC Principal Consultant, GlobalData