Archives: Agenda

China’s pharmaceutical innovation stands at a pivotal inflection point. After a decade of explosive growth, the industry is navigating a period of “capital winter,” intense policy-driven competition, and a strategic shift from the pursuit of quantity to the mandate of quality. However, this pressure is also a catalyst, forcing a clear-eyed re-evaluation of the path forward. Today, China is not just a vast clinical trial hub or a manufacturing powerhouse; it is defining its ambition to become a “world new drug creation center” by 2035.
中国医药创新正处在关键转折点。经历十年的爆发式增长后，行业经历了“资本寒冬”、政策驱动的激烈竞争，以及从追求数量转向强调质量的战略变化。在这种压力下，行业对未来发展有了更清醒的认识。现在，中国不再只是庞大的临床试验中心或制造强国；它正在定义到 2035 年成为“世界新药创制中心”的雄心。

• The “Innovation Pivot”: From Fast-Follower to First-in-Class
• The “Globalization 2.0” Playbook: From BD Transactions to Enduring Value
• The “Dual Engine” of Policy: Regulatory Acceleration Meets Payment Reformation
• Convergence and Concentration: Surviving the “Great Integration”
• The Ultimate Alignment: Bridging the Pipeline to Unmet Clinical Need

•  “创新转向”：从快速跟随到 First-in-Class
•  “全球化 2.0”打法：从 BD 交易到持久价值
•  政策“双引擎”：监管加速与支付改革并进
• 融合与集中：在“大整合”中生存
• 终极方案：将管线与未满足的临床需求相适配

Moderator: Sarah Nightingale, APAC Principal Consultant, GlobalData

• Understanding country-specific site application and approval requirements
• Reducing start-up timelines through effective planning and local partnerships
• Common challenges and pitfalls when activating sites across multiple regions
• Best practices for successful collaboration with investigators, sites, and regulators

• 了解各国特定的中心申请与审批要求。
• 通过有效规划和本地合作伙伴关系缩短启动时间。
• 跨多个区域启动中心时常见的挑战和陷阱。
• 与研究者、中心和监管方成功协作的最佳实践

A single biopharma portfolio today may encompass a diverse mix of modalities—small molecules, monoclonal antibodies, ADCs, cell therapies, and more—each with vastly different and often contradictory supply chain requirements. This new reality demands a fundamental shift towards platform-based supply chain strategies.

• What Are We Actually Building?
• Orchestrating Complexity with Data & AI
• From Transactional Vendors to Strategic Capability Partners
• Upskilling Teams for a Multi-Modality World

如今，单一生物医药企业的研发管线可能涵盖多种不同的药物模态——小分子、单克隆抗体（单抗）、抗体偶联药物（ADCs）、细胞疗法等。这些药物对供应链的要求截然不同，甚至相互冲突。这一新现状要求供应链管理必须发生根本性转变，全面走向平台化策略。

• 我们究竟在构建什么？
• 利用数据与人工智能（AI）协调整合复杂流程
• 从传统的交易型供应商转型为战略能力合作伙伴
• 赋能团队升级，全面迎接多模态时代

Expanding clinical trials into China requires more than a global strategy, it requires local execution. In this session, Emsere will share how a smarter equipment rental and management strategy can simplify clinical trial operations, reduce logistical complexity, and ensure equipment is available when and where it’s needed. Learn how combining global standards with local expertise helps sponsors execute successful clinical trials in China. 将临床试验拓展至中国，不仅需要具备全球化的战略眼光，更需要扎实的本土化执行力。在本次专题中，Emsere 将分享如何通过更智慧的设备租赁与管理策略来简化临床试验运营、降低物流复杂度，并确保设备能够在所需的时间和地点精准交付。您将了解到，如何将全球统一标准与本土专业经验相结合，从而助力申办方在中国成功执行临床试验。

• Selecting the right countries and sites to support global development goals
• Using real-world data and feasibility insights to improve decision-making
• Aligning site selection with recruitment, operational, and regulatory strategies
• Creating scalable site networks for long-term global clinical development success

• 选择合适的国家和中心，以支持全球开发目标。
• 利用真实世界数据和可行性洞察改善决策。
• 将中心选择与招募、运营和法规策略相结合。
• 建立可扩展的中心网络，实现长期全球临床开发成功。