Archives: Agenda

• The Rise of China’s Biotech Industry: The Chinese government’s “Made in China 2025” strategy and its impact on biotech innovation.
• The role of China’s National Medical Products Administration (NMPA) in accelerating drug
• The Role of Venture Capital in China’s Biotech Boom; How Chinese VCs and state-backed funds are fueling biotech startups and the differences between U.S. and Chinese biotech funding models.
• Competitive Pressure on S. Biotech Firms.
• Regulatory & Geopolitical Challenges: The impact of U.S.-China trade tensions and export controls on biotech collaboration.

Moderator:

Claire Qin, Chief Strategy Officer, Intelligen AI; BioPharma Investor

中国生物科技产业迅猛发展，在药物研发、临床试验及全球市场拓展方面对美国生物科技企业构成日益激烈的竞争。凭借政府强力支持、资本优势及创新疗法管线的持续扩充，在风险投资（VC）加持下的中国生物科技企业正在重塑行业格局。本环节将深入分析竞争态势、美国企业面临的挑战以及全球生物科技创新的未来走向。

• 中国生物科技产业崛起：”中国制造 2025″战略对生物科技创新的推动效应
• 监管加速作用：中国国家药品监督管理局（NMPA）在新药审批中的角色演进
• 资本驱动力量：中美国际资本运作模式差异——中国风险投资与政府基金如何赋能生物科技初创企业
• 美国企业的竞争压力：核心技术与市场份额的双重挑战
• 监管与地缘政治因素：中美贸易摩擦及出口管制对生物科技合作的影响

主持嘉宾:

秦祯，首席战略官，Intelligen AI

During the roundtable discussion session, the conference hall will be divided into zones. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within the industry. After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

ROUNDTABLE 1
What key aspects of inspection readiness should be considered right now? Hosted By Claire Qin, Chief Strategy Officer, Intelligen AI; BioPharma Investor

ROUNDTABLE 2
Getting the best out of your sponsor – CRO partnership
Hosted by Megan Qin, Head of Medical Device Clinical Excellence Working Group, CMAC

ROUNDTABLE 3
Ensuring clinical quality assurance in supply chain management
Hosted By Daniel Gao, President, ISPE Supply Chain Committee

互动式圆桌会议为您提供与同行深入交流的独特机会，共同探讨行业关键挑战的解决方案并分享最佳实践。每场 讨论由行业专家主持，聚焦单一议题，通过高互动形式拓展人脉网络，汲取他人经验智慧。 （每场圆桌讨论时长30分钟，参会者可轮换参与）

圆桌议题 1：中国药企出海的机遇与挑战

主持嘉宾：秦祯，首席战略官，Intelligen AI

圆桌议题 2：如何构建最优申办方-CRO 合作伙伴关系

主持嘉宾：秦飞，卓越临床联盟医疗器械工作组负责人，CMAC

圆桌议题 3：临床试验供应链质量管理保障机制

主持嘉宾：高晓伟，主席，ISPE 供应链分委会

• Global clinical trial supply outline and
• Strategies to minimize delays in clinical supply
• Implementing effective communication through ‘Huddles’.
• Practical Solutions for Streamlining Supply Chain

Moderator:

Daniel Gao, President, ISPE Supply Chain Committee

• 全球临床试验供应的布局和计划
• 临床供应链物流延迟最小化方案
• 通过”短频快”沟通机制提升协同效率
• 供应链流程优化实战案例解析

主持嘉宾:

高晓伟，主席，ISPE 供应链分会

Clinical trial standards are increasingly rising, while domestic innovative pharmaceutical companies continue to leverage their R&D efficiency advantages to rapidly advance clinical research and achieve first- mover advantages. In such an environment, how to better collaborate with partners to enhance clinical trial operational capabilities and the reliability of clinical drug supply has become a crucial topic.

• Challenges and Best Practices in Clinical
• Achieving Efficient Clinical Trials by Better Leveraging CRO Capabilities.
• Higher Quality and More Compliant Clinical Trial Drug Supply.
• Complex Packaging Design and Blinding Case

临床试验的标准日益提升，同时国内创新药企不断发挥 研发效率优势，快速推进临床研究，实现先发优势。如 何在这样的环境中，更好的和合作伙伴配合，提升临床 试验运营能力和临床药品供应可靠性，成为至关重要的 话题

• 临床运营阶段的挑战和最佳实践
• 更好借助 CRO 能力实现高效临床
• 高质量更合规的临床试验药品供应
• 复杂包装设计和编盲案例

Outsourcing and supply chains are being reshaped by global disruption and changes in the drug industry. Join Fiona Barry for an interactive deep dive into clinical trial supply trends, risks, and innovations.

• The latest global trends in clinical trial supply and
• How geopolitical shifts are reshaping supply chain
• Practical approaches for tackling drug shortages and managing risk.
• Insights from a survey of industry leaders in APAC, North America, and Europe

• 临床试验供应与外包的最新全球趋势
• 地缘政治变化如何重塑供应链战略
• 应对药品短缺与管理风险的实用策略
• 来自亚太、北美及欧洲行业领袖的调研洞见

Compared to traditional pharmaceutical companies, the development and advancement of clinical pipelines employ significantly different strategies and methodologies. In response to the international R&D and clinical environment, targeted clinical development planning is required, with distinct operational priorities and practices.

• Artificial Intelligence Accelerates Global Drug Development Planning.
• Global Clinical Trial Strategy and
• Best Practices for Efficient Global Drug
• Packaging Strategies and Protocols for Clinical

英矽智能是全球领先的 AI 驱动生物科技公司，专注于 利用人工智能技术加速药物研发。和传统药企相比，临 床管线的开发和推进有着非常不同的策略和方法。针对 国际化的研发和临床环境，需要针对性的临床研发布 局，在运作层面也有不同的重点和实践

• 人工智能加速全球药物研发布局
• 全球临床试验策略和布局
• 全球高效药品供应的最佳实践
• 针对临床方案的包装策略和方案