Archives: Agenda

Managing Complex Logistics for ADC and Bi-Specific Antibody Clinical Trials ADC 与双特异性抗体临床试验的复杂物流管理

Antibody-Drug Conjugates (ADCs) and Bi-Specific Antibodies (BsAbs) represent the cutting edge of targeted oncology therapeutics. The delicate balance of the ADC structure (linker, antibody, payload) and the intricate assembly of the BsAb (two distinct binding domains) impose unprecedented demands for coordination and control across every logistical step, from manufacturing to the patient’s bedside.
抗体偶联药物（ADC）和双特异性抗体（BsAb）代表了靶向肿瘤治疗的前沿。ADC 结构（连接子、抗体、载荷）的精密平衡，以及 BsAb（两个不同结合结构域）的复杂组装，对从产线到病床的每一个物流环节都提出了前所未有的挑战。

  • Identifying Critical Vulnerabilities in ADC & BsAb Supply Chains
  • Strategies from Point-of-Manufacture to Global Distribution
  • How to Leverage IoT and Blockchain for End-to-End Traceability from Factory to Bedside
  • Dynamic Strategies for Dose Escalation & Biomarker-Driven Patient Stratification
  • Leveraging China’s Mature Biologics Supply Chain Ecosystem

 

  • 识别 ADC 与 BsAb 供应链中的关键节点
  • 从生产端到全球配送的策略
  • 如何利用 IoT 与区块链实现从产线到病床的端到端可追溯性
  • 剂量递增与生物标志物驱动患者分层的动态策略
  • 借力中国成熟的生物制品供应链生态

PANEL DISCUSSION AI & DCT: Transforming Clinical Trial Delivery in China 圆桌讨论：AI +DCT：重塑中国临床试验交付

  • AI as Digital Workforce: Automating Clinical Operations and Intelligent Data Quality Control under ICH E6(R3)
  • From Pain Points to Solutions: DCT Application & Landing Practice

 

  • AI 作为数字化劳动力：在 ICH E6(R3) 框架下实现临床运营自动化与智能数据质量控制。
  • 从痛点到解决方案：DCT 应用与落地实践

Moderator: Suqin Xia, Founder, DCT Academy

Panelists:

1.     BioPharma

2.     BioPharma

3. Reserved for Event Sponsor

CASE STUDY 案例研究 Inner-Ear Gene Therapy — From Target to IND: How China’s Integrated CRO/CDMO Ecosystem Accelerates CGT Translation 内耳基因疗法 – 从靶点到 IND：中国CRO/CDMO 生态如何加速 CGT 转化

  • Proof of concept established: 2.5-year follow-up data for OTOF gene therapy demonstrate that inner-ear gene therapy is safe, effective, and delivers predictable therapeutic outcomes.
  • The target-to-IND pathway is mature: parallel workflows + a dense CRO/CDMO ecosystem + an integrated CRDMO model enable China to move from discovery to IND 50–70% faster than the global norm.
  • Supply chain readiness determines successful delivery: cold-chain logistics, potency testing, and end-to-end regulatory compliance systems (NMPA/QMS) are critical to the scaled delivery of cell and gene therapies (CGT).
  • Structural advantage: national strategic tailwinds + partners’ end-to-end delivery capabilities help Chinese companies such as Euhearing Therapeutics accelerate CGT implementation.

 

  • 概念验证已成立: OTOF 基因治疗 2.5 年随访数据证明内耳基因治疗安全、有效且疗效可预测。
  • 从靶点到 IND 已成熟: 并行化工作流 + 密集 CRO/CDMO 生态 + CRDMO 一体化,使中国「发现→IND」周期比全球快 50–70%。
  • 供应链就绪决定落地: 细胞与基因治疗(CGT)的冷链、效价与全程监管链(NMPA/QMS)是规模化交付的关键。
  • 结构性优势:国家战略红利 + 合作伙伴端到端交付，有助于以佑音医药等为代表的中国企业加速 CGT 落地。

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

PRIZE DRAW

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