Archives: Agenda

• The 3+3 design is simple but has limited statistical performance, failing to meet modern Phase I R&D needs.
• BOIN is a model-assisted design whose core centers on constructing optimal decision intervals around the target toxicity rate.
• BOIN combines strong statistical performance with high clinical feasibility.
• Compared to 3+3, BOIN allocates patients more rationally and improves MTD accuracy.
• BOIN has evolved into a design family that extends to efficacy, combination therapies, late-onset toxicities, and OBD optimization.

• 3+3 简单但统计性能有限，已难满足现代 I 期研发需求。
• BOIN 是模型辅助设计，核心是围绕目标毒性率构建最优决策区间。
• BOIN 兼具较强统计性能与较高临床可实施性。
• 相比 3+3，BOIN 能更合理分配患者并提高 MTD 准确率。
• BOIN 已发展为设计家族，可扩展到疗效、联合用药、迟发毒性和 OBD 优化等场景。

• How to build a “Predict and Prevent” Supply Mindset
• Dynamic Re-supply Models for a Dynamic Clinical Reality
• A Step-by-Step Guide to Smoother Cross-Border Movements
• Rapid Response Protocols and Effective Contingency Planning
• Integrating Partners into a Single, Seamless Team

• 如何建立“预测并预防”的供应思维。
• 面向动态临床现实的动态补货模型。
• 更顺畅跨境运输的分步指南。
• 快速响应流程与有效的应急规划。
• 将合作伙伴整合为一个无缝协作团队。

Moderator: Jae-Young Ha, CBO, AriBio

下午茶歇及交流

下午茶歇及交流

• Leveraging China’s integrated research, healthcare, and technology networks to accelerate development
• How scale, speed, and digital innovation are reshaping global clinical trial execution
• Translating local operational excellence into global study success
• Less on drug supplys multinational sponsors can apply from China’s evolving clinical ecosystem

• 借助中国一体化的科研、医疗和技术网络加速开发。
• 规模、速度与数字化创新如何重塑全球临床试验执行。
• 将本土运营卓越转化为全球研究成功。
• 跨国申办方可从中国不断演进的临床生态中借鉴的经验。

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

• 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

• 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。