Archives: Agenda

• 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

A single biopharma portfolio today may encompass a diverse mix of modalities—small molecules, monoclonal antibodies, ADCs, cell therapies, and more—each with vastly different and often contradictory supply chain requirements. This new reality demands a fundamental shift towards platform-based supply chain strategies.

• What Are We Actually Building?
• Orchestrating Complexity with Data & AI
• From Transactional Vendors to Strategic Capability Partners
• Upskilling Teams for a Multi-Modality World

如今，单一生物医药企业的研发管线可能涵盖多种不同的药物模态——小分子、单克隆抗体（单抗）、抗体偶联药物（ADCs）、细胞疗法等。这些药物对供应链的要求截然不同，甚至相互冲突。这一新现状要求供应链管理必须发生根本性转变，全面走向平台化策略。

• 我们究竟在构建什么？
• 利用数据与人工智能（AI）协调整合复杂流程
• 从传统的交易型供应商转型为战略能力合作伙伴
• 赋能团队升级，全面迎接多模态时代

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。

• Selecting the right countries and sites to support global development goals
• Using real-world data and feasibility insights to improve decision-making
• Aligning site selection with recruitment, operational, and regulatory strategies
• Creating scalable site networks for long-term global clinical development success

• 选择合适的国家和中心，以支持全球开发目标。
• 利用真实世界数据和可行性洞察改善决策。
• 将中心选择与招募、运营和法规策略相结合。
• 建立可扩展的中心网络，实现长期全球临床开发成功。

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

• 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