Archives: Agenda
Patient Centricity in Clinical Trials: A New Era in China 以患者为中心的临床试验：中国新时代
As China’s clinical trial ecosystem evolves, there is a growing emphasis on patient-centric approaches to improve recruitment, retention, and overall trial outcomes. This session will explore strategies to enhance patient engagement, leverage digital health solutions, and address cultural and regulatory considerations for patient-centric clinical trials in China.
- Understanding the Shift Toward Patient- Centric Trials in China.
- Enhancing Patient Recruitment and Retention
- Digital Health and Remote Monitoring in Patient- Centric Trials.
- Regulatory and Ethical
随着中国临床试验生态系统的演进，聚焦患者需求的 模式正显著提升受试者招募、留存及整体试验质量。 本环节将探讨如何通过数字化健康解决方案增强患者 参与度，并解析中国患者中心式试验中的文化适应性 与监管要求
- 去中心化临床试验 DCT 的发展历程
- 国内外相关法规对 DCT 的指导要求
- DCT 技术在临床研究中的具体应用和实践
- 关于 DCT 发展趋势的展望和应对。
Chairperson’s opening remarks 主席开幕致辞
AI-Driven New Paradigm for Healthcare AI 驱动的医疗健康新范式
- Government & Regulation: From “Approver” to “Ecosystem Cultivator and Rule-Maker”.
- Pharmaceutical Companies: From “Drug Suppliers” to “Key Ecosystem Builders and Enablers”.
- Medical Institutions: From “Service Endpoints” to “Data-Driven Innovation Hubs”.
- Patient Population: From “Passive Recipients” to “Empowered Active Health Partners”.
- 政府与监管：从“审批者”到“生态培育者与规则制定者
- 医药企业：从”药品供应商“到”生态系统的关键构建者与赋能者“
- 医疗机构：从“服务终端”到“数据驱动的创新协同中心”
- 患者群体：从”被动受众“到”自我赋能的主动健康伙 伴
Use of RWE in Neurovascular Medical Device Example 真实世界证据在神经血管医疗器械应用示例
- Clarifying the differences in using the terms RWE vs
- Proving examples of RWE sources available: commercial, society, private.
- Case study to explain a detailed implementation of RWE to support an expanded indication for a medical device
- RWE（真实世界证据）与 RWD（真实世界数据）术语使用的区别
- 现有 RWE 来源的实例：商业数据库、学会数据、私有数据源
- 如何运用真实世界证据支持医疗器械适应症扩展的案例介绍
Morning refreshments and networking – Please visit 3 booths in this break 上午茶歇与交流互动——请在此期间至少参观 3 个展位
From Regional to Global: Best Practices for Progressing Your Drug Development 从区域到全球：推动药物研发的最佳实践
- Understanding the current biotech landscape.
- Top considerations for future development.
- Engaging a global CRO.
- 了解当前生物技术领域的发展态势
- 未来发展的关键考量因素
- 如何与全球 CRO 建立合作
The Clinical Trial Landscape for Small to Mid- Sized Biopharma in China 中小型生物制药企业在华临床试验发展路径
- New regulations and guidance around clinical trials in China: how will this impact you?
- Navigating the constantly evolving vendor and CRO landscape as a small to mid sized sponsor
- An overview of technology and innovation in the clinical trial industry: what’s working and what isn’t?
- 中国临床试验新规解读：对中小型企业的实际影响
- 动态变化的 CRO/供应商生态应对策略
- 临床试验技术创新应用评估：有效方案与现存瓶颈
- 海南封关对中国医药企业的影响与机遇
Globalization of Phase 1 Clinical Trials to Maximize Program Delivery and ROI 一期临床试验全球化：最大化项目交付与投资回 报
- Summary of market data and where Phase 1 studies are being performed.
- What are investors looking for from Phase 1 clinical trial datasets?
- What and where can Phase 1 studies be done to meet or exceed market demands?
- Review relevant case studies given recent China Biotechs market success.
- 市场数据总结及一期临床试验开展地区分析
- 投资者对一期临床试验数据的关键需求
- 满足或超越市场需求的一期临床试验方案及实施地点
- 结合中国生物科技公司近期市场成功的相关案例研究
Implementing Artificial Intelligence in Drug Discovery and Development in China 人工智能（AI）在中国药物研发中的应用实践
- AI integration across the drug development lifecycle
- Building AI-driven drug discovery pipelines in China
- Overcoming challenges in AI adoption
- Success case study from Degron
中国正快速将人工智能（AI）整合到药物研发和临床开发中，这得益于机器学习、大数据分析的进步以及政府对生物技术创新的支持。本环节将聚焦AI从早期发现到监管申报的实际应用，并探讨企业如何在不断变化的中国监管环境中成功利用AI技术。
- AI在药物研发全生命周期中的整合
- 构建AI驱动的中国药物研发管线
- AI技术落地面临的挑战与应对
- 达歌生物成功案例分享