Archives: Agenda

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

• 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。

AI is reshaping the entire lifecycle of GLP-1 drug development. This presentation will systematically examine the specific applications of AI technology across the entire R&D chain, covering early-stage molecular design, activity and toxicity prediction, clinical trial design optimization, and optimized scheduling within the clinical supply chain. Using a case study of MindRank’s MAP platform, the session will analyze how AI-driven approaches improve R&D efficiency, reduce costs, and shorten timelines, ultimately advancing a candidate drug into Phase III clinical trials within 4.5 years.

AI正在重塑GLP-1药物的研发全链条。本报告将系统阐述AI技术在药物研发全生命周期中的具体应用，涵盖早期分子设计、活性与毒性预测、临床试验设计优化，以及临床供应端的优化调度。报告将结合德睿智药MAP平台的实际案例，分析如何通过AI驱动的方案提升研发效率、降低成本并缩短周期，并在4.5年内将相关候选药物推进至三期临床试验。

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

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