PANEL DISCUSSION: Staying Ahead of the Curve: Key Trends Transforming Clinical Trials 圆桌讨论:保持领先:重塑临床试验的关键趋势

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

How biotech companies can build operational excellence into trials from the outset 打造卓越的临床方案设计

  • 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。

Supply Chain Readiness for Cell and Gene Therapy Trials in China 中国CGT供应链实践

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

Clinical Supply Practices in MRCT MRCT 中的临床供应实践

  • 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

KEYNOTE PANEL: The Patient Enrollment Revolution: Global Lessons from China’s Clinical Trial Efficiency 主题圆桌:患者入组革命:中国临床试验效率带来的全球启示

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

OPENING KEYNOTE: China’s Biopharma Leap: From Fast-Follower to Global Innovator 开幕主题演讲:中国生物医药的跃升:从快速跟随到引领创新

China stands at an inflection point in global biopharma innovation. Having mastered the art of rapid development and commercialization as a fast-follower, the industry is now making a decisive strategic pivot towards becoming a true globald innovator. The rise of China-led international multi-center trials (MRCTs) and landmark global partnerships underscores a new reality: China is no longer just a vast market or a development executor, but a primary source of scientific insight and therapeutic value.

中国正处于全球生物医药创新的关键转折点。随着中国临床的蓬勃发展,现在已经逐渐引领全球创新。由中国主导的多中心临床试验(MRCT)以及具有里程碑意义的全球交易,正在展示着中国在临床试验中的角色转变——从全球申办方的执行中心,转变为科学前沿与医药创新的重要源头

  • From “Fast Follower” to Autonomous Innovation
  • Leveraging China’s Capabilities for Worldwide Development
  • From Local Assurance to Global Collaboration
  • Aligning Standards and Achieving Mutual Recognition
  • Building an Open, Collaborative Global Network

 

  • 从“快速跟随”到自主创新
  • 借助中国能力推动全球开发
  • 从本土保障到全球协作
  • 标准统一与互认
  • 建立开放、协作的全球网络