Archives: Agenda

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

Clinical development is being reshaped by technology, new regulations, and a patient=centric focus. This panel will analyse key trends, from virtual trials to AI, separating hype from reality and providing a practical roadmap for leading the next generation of clinical research.
临床开发正在受到技术、新法规和以患者为中心理念的重塑。本圆桌将分析从虚拟试验到 AI 的关键趋势，区分炒作与现实，并为引领下一代临床研究提供实用路线图。

• Practical Implementation of DCTs & Hybrid Models
• Integrating RWE, AI, and Advanced Analytics
• Evolving from Recruitment to True Engagement
• Adapting SOPs, Vendor Partnerships, and Risk Management
• Regional Variations in Adopting Next-Generation Trials

• DCT 与混合模式的实践落地
• 整合 RWE、AI 与高级分析
• 从患者招募迈向真正的患者参与
• 调整 SOP、供应商伙伴关系与风险管理
• 下一代试验在不同区域的采用差异

Moderator:  Rachel Wang, Consultant, Deallus

As more Chinese biotech companies expand clinical development beyond China, the question is no longer whether to go global, but how to build globally ready development programs from the outset. Drawing on practical experience and industry observations, this presentation will explore the critical decisions sponsors face across development planning, regulatory strategy, study execution, and operational readiness. It will also share common challenges, lessons learned, and practical considerations to help organizations better prepare for clinical development across the US, Europe, and other international markets.

随着越来越多中国创新药企业加速国际化布局，当前面临的关键问题已不再是是否走向全球，而是如何从研发早期建立符合全球要求的临床开发策略。本次分享将结合实践经验与行业观察，探讨企业在全球临床开发过程中面临的关键决策，包括开发规划、注册策略、研究执行及运营准备等内容，并分享常见挑战、实践经验和可借鉴的建议，帮助企业更好地规划美国、欧洲及其他国际市场的临床开发。

The rise of Cell and Gene Therapies presents a formidable supply chain challenge due to their nature as “living drugs.” Success in China’s CGT clinical trials thus hinges on mastering a complex, time-sensitive, and patient-centric logistical system to translate the immense potential of these therapies into reliable patient outcomes.
细胞与基因疗法的兴起为供应链带来了严峻挑战，因为其本质上属于“活体药物”。因此，中国 CGT 临床试验的成功取决于能否掌握复杂、时间敏感且以患者为中心的物流体系，将这些疗法的巨大潜力转化为可靠的患者结果。

• What is the Unique CGT Challenge
• Assessing China’s Readiness in Cryogenic Logistics, GMP Facilities & Single-Use Technologies
• Orchestrating the “Vein-to-Vein” Journey with Real-Time Tracking & Chain of Custody
• Navigating NMPA Guidelines and Building QMS for Advanced Therapies
• The Integrated Role of Specialized CDMOs, Logistics Providers & Clinical Sites

• CGT 的独特挑战是什么
• 评估中国在低温物流、GMP 设施和一次性技术方面的准备度
• 通过实时追踪和监管链管理“从静脉到静脉”的全流程
• 解读 NMPA 指南并为先进疗法建立 QMS
• 专业 CDMO、物流供应商与临床中心的一体化角色

• Designing protocols with site and patient feasibility in mind to reduce complexity and accelerate recruitment.
• Embedding operational planning early to improve timelines, budget predictability, and study execution.
• Leveraging digital technologies, data, and AI to streamline trial management and reduce administrative burden.
• Building collaborative partnerships with sites, CROs, and technology providers to drive efficient, high-quality trial delivery.

• 在方案设计阶段纳入中心和患者可行性考量，降低复杂度并加速招募。
• 尽早嵌入运营规划，以改善时间线、预算可预测性和研究执行。
• 利用数字技术、数据和 AI 简化试验管理并减少行政负担。
• 与中心、CRO 和技术供应商建立协作伙伴关系，推动高效、高质量的试验交付。

• Regulatory Compliance: Navigating strict NMPA oversight and IP-GMP rules for MRCT integration.
• Sourcing Strategy: Utilizing local procurement and bonded zones to bypass customs delays.
• Labeling Standards: Implementing mandatory Simplified Chinese text while maintaining blinding integrity.
• Domestic Logistics: Managing secure cold-chain distribution networks across vast hospital networks.
• Chain of Custody: Executing meticulous drug reconciliation leading to certified local destruction.

• 法规合规：应对 NMPA 严格监管以及 MRCT 整合中的 IP-GMP 规则。
• 采购策略：利用本地采购和保税区政策避免清关延误。
• 标签标准：落实强制性简体中文文本要求，同时保持盲法完整性。
• 国内物流：在广泛的医院网络中管理安全的冷链配送网络。
• 监管链：执行细致的药品核对，直至获得认证的本地销毁

This presentation systematically addresses the core challenges and efficient execution strategies of supply chain management for MRCTs. It delivers practical management frameworks and partner selection methodologies for clinical operations and supply chain managers to improve trials’ overall execution quality and speed. 本演讲将系统性地阐述多区域临床试验（MRCTs）中供应链管理的核心挑战与高效执行策略。演讲将为临床运营与供应链经理提供实用的管理框架以及合作伙伴选择方法论，以全面提升临床试验的执行质量与速度。

（请至少参观3个展位）

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。

• How China Building Beyond “Population Advantage”
• How to Leverage AI and Digital Platforms in Patient Matching
• The Power of Hospital Alliances and Regional Clinical Hubs
• Aligning Patient Recruitment, Clinical Supply Strategy And Site Readiness To Reduce Delays
• How to Adapt China’s Model for International Multi-Center Trials

• 中国不仅是“人口优势”
• 如何利用 AI 与数字平台进行患者匹配
• 医院联盟与区域临床中心的发展
• 患者招募、临床供应策略的动态调整
• 如何将中国模式应用于MRCT

Moderator: Sarah Nightingale, APAC Principal Consultant, GlobalData