Archives: Agenda

• 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 supply 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。

• 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

• 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。

• Exploring the capability of Digital Display Labels (DDLs) and the benefits for Clinical Trial Supplies
• A demonstration of the functionality of DDLs; just in time labelling, lot & expiry update, multiple page count.
• Understanding the operational ability to securely & remotely update content & language.
• Integrating across IMP profiles, vials, bottles, blisters

• 探究数字显示标签（DDLs）的技术能力及其对临床试验供应带来的效益
• 现场演示数字显示标签（DDLs）的功能：实时/即时标签贴签、批号与有效期更新、多页面内容切换
• 深入了解其运营能力：如何安全地进行远程内容及语言更新
• 实现全方位集成整合：涵盖试验用药品（IMP）构型、西林瓶、药瓶及铝箔水泡眼包装（泡罩包装）

Akesa专场

• 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。

Many countries across the globe have enacted privacy laws and now Healthcare Authorities and Ethics Committees mandate that Clinical Trial Applications contain appropriate data privacy language. The good news is that it is simple in the Life Science industry because Good Clinical Practices have always protected the Rights of the Patients since the Code of Nuremberg in 1949. Participants will understand how to do it right the first time, they will learn the key points of attention, so the clinical trial is not delayed.

全球许多国家已颁布隐私法。目前，各国医疗卫生当局和伦理委员会均强制要求临床试验申请（CTA）中包含适当的数据隐私表述。值得庆幸的是，生命科学行业在此方面有深厚积累——自1949年《纽伦堡法典》问世以来，”临床试验规范“（GCP）就一直致力于保护患者权益。本演讲/课程将帮助参会者了解如何从源头实现合规的正确路径，并深度剖析关键风控点，以避免临床试验的延误。

• 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。