Moderator: Daniel Gao, President, ISPE Supply Chain
Panelists:
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.
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。
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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。
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。