Archives: Agenda

Forcing a single clinical supply model across APAC creates delays, costs, and regulatory risks. This presentation addresses regional complexities through flexible strategies and local collaboration.

• Model Selection: Evaluating central, regional, and hybrid supply frameworks.
• Streamlined Logistics: Bridging gaps between sourcing, compliance, and local distribution.
• Risk Mitigation: Overcoming cross-border bottlenecks and critical documentation challenges.
• Strategic Value: Balancing speed, cost, and long-term partner alignment over transactional relationships.

在亚太地区强推单一的临床供应链模型会导致延误、高昂成本和合规风险。本演讲将通过灵活的战略与本地化合作，探讨并解决这些区域复杂性问题。

• 模式选择：评估集中式、区域式以及混合式的供应链架构。
• 高效物流：消除采购、合规与本地分销之间的断层。
• 风险缓解：克服跨境瓶颈与关键文件审查带来的挑战。
• 战略价值：权衡速度与成本，建立长期的伙伴协作，而非单纯的业务交易

• 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。

• Globalizing Early-Phase Development: Explores expanding opportunities for biopharmaceutical innovators to run Phase 1 trials internationally.
• Strategic Regional Advantages: Showcases destinations like Australia that offer rapid regulatory pathways, cost efficiencies, and universally accepted data.
• Operational Optimization: Uses case studies to highlight strategies for accelerating timelines, optimizing study designs, and reducing costs.
• Commercial Success: Illustrates how multi-region early-phase data drives robust partnering, licensing, and subsequent clinical success.

• 早期开发全球化： 探讨生物医药创新企业在国际上开展一期（Phase 1）临床试验的拓展机遇。
• 区域战略优势： 展示澳大利亚等基地的独特优势，包括快速的监管审批通道、高性价比以及全球通用的临床数据。
• 运营层面优化： 运用案例分析，重点阐述加速项目时间线、优化试验设计以及降低成本的有效策略。
• 商业成功助力： 阐明多区域早期临床数据的融合如何强力推动商务合作、品种授权以及后续临床研究的成功。

Chinese biotech is moving faster than ever from innovation to global ambition — but the challenge now goes beyond developing a differentiated asset. It’s proving that asset’s value early, generating globally credible clinical data, and reaching the right international partners before momentum fades. Drawing on real-world case studies, this session examines how delays at proof-of-concept erode value, how regulatory and operational efficiency compress development timelines, and how Chinese biotechs can expand globally without slowing execution. Attendees will gain practical insight into how faster PoC, stronger patient access, efficient global trial deployment, and high-quality international data strengthen partnering discussions and make assets more attractive to global pharma.

中国生物医药产业正以前所未有的速度从“本土创新”迈向“全球雄心”。然而，企业如今面临的挑战已不仅限于研发具有差异化的资产，更在于如何在早期证明资产价值、生成具备全球公信力的临床数据，并在市场热度消退前精准对接国际合作伙伴。本议程将结合真实世界案例研究，深入探讨概念验证（PoC）阶段的延迟如何侵蚀资产价值、如何通过提升监管与运营效率来压缩研发周期，以及中国药企如何在不牺牲执行速度的前提下实现全球化扩展。参会者将获得极具实用价值的行业洞察，明确如何通过加速PoC进程、强化患者招募、高效部署全球临床试验以及获取高质量国际数据，来增加商务谈判筹码，从而让管线资产对跨国药企（Global Pharma）更具吸引力。

• Embedding agility into study decision models to intelligently support decentralized and hybrid trial models.
• Creating connected DCT ecosystems to shorten study timelines and reduce overall operational burden.
• Leveraging AI-driven insights to optimize end-to-end patient support and long-term adherence.
• Intelligent Medication Management & Safety Monitoring with smart pillboxes to enable closed-loop medication adherence and safety surveillance.

• 将动态适应嵌入研究决策模型，智能支持去中心化和混合型试验模式。
• 打造互联的 DCT 生态系统，缩短研究周期并降低整体运营负担。
• 利用 AI 驱动洞察，优化端到端患者支持和长期依从性。
• 通过智能药盒实现智能用药管理与安全监测，形成闭环用药依从性和安全监测。

• 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。

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

• 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