Archives: Agenda

• Evaluating CRO capabilities and experience relevant to your specific therapeutic area and development stage
• Balancing cost, quality and timelines within tight budget constraints
• Negotiating contracts with flexibility to protect your biotech’s goals

This session will explore whether the FDA’s Real-Time Clinical Trials (RTCT) program is an aspirational vision for the future or a near-term reality that biotech companies should begin preparing for today. This session will discuss what sponsors can do now to position themselves for participation in this emerging real-time development model.

• Separate hype from reality: Examine FDA’s stated goals for RTCTs, the scope of the pilot program, and its potential opportunities and limitations.
• Understand the broad operational and technology requirements: Identify the critical capabilities needed for participation in the pilot program.
• Develop your biotech readiness roadmap: Discuss practical actions sponsors can take today to assess their organizational readiness and engage with FDA as the RTCT model evolves.

• What “real time” looked like from the sponsor side when site activity became visible only after the work was complete
• How late queries and accessioning delays slowed data readout in a Phase I oncology study
• What changed when issues were identified and corrected before shipment
• Why clinical trial execution is foundational to better data and AI-ready trials

Hybrid operating models offer flexibility in how sponsors and CROs divide responsibilities, but success depends on how effectively those responsibilities are integrated across the study lifecycle. Drawing on lessons learned from a complex oncology clinical trial with an accelerated start-up timeline and sites selected before CRO engagement, this session explores practical strategies for establishing clear governance, coordinating sponsor- and CRO-managed functions, and creating a unified operational approach that accelerated site activation, supported first patient in, and sustained enrollment momentum despite a highly distributed delivery model.

The session will explore:

• Defining clear sponsor and CRO roles, governance structures, shared timelines, ownership, and decision-making frameworks to drive accountability and enable seamless execution within a hybrid operating model.
• Managing cross-functional vendors, technology integrations, and operational dependencies to proactively identify and mitigate execution risks.
• Building a unified sponsor-CRO approach for site engagement through aligned communication, coordinated oversight, and shared expectations to strengthen collaboration and enhance the site experience.
• Applying cross-functional readiness planning and proactive risk management strategies to accelerate study start-up, support first patient in, and drive enrollment success.

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