Navigating Clinical Operations in Biotech’s Survival Mode 生物医药寒冬之下:如何驾驭临床运营的“生存模式”

  • Building Cross-Functional Leadership: Developing “T-shaped” talent with end-to-end operational vision.
  • Proactive Risk Management: Systematically anticipating and mitigating clinical trial risks.
  • Strategic Partnership with CROs: Redefining sponsor-CRO collaboration beyond transactional outsourcing.
  • From Trial Data to Market Value: Making clinical quality the cornerstone of biotech IPO credibility.

 

  • 构建跨职能领导力: 培养具备端到端(全流程)运营视野的“T型”复合型人才。
  • 前瞻性风险管理: 系统性地预测并缓解临床试验过程中的潜在风险。
  • 与 CRO 的战略合作伙伴关系: 重新定义申办方与 CRO 的合作模式,摆脱单纯的“交易型外包“。
  • 从试验数据到市场价值: 让临床质量成为生物医药企业 IPO(上市)公信力的基石。

PANEL DISCUSSION: Global Site Activation: Navigating Overseas Clinical Trial Applications 圆桌讨论:全球中心启动:海外临床试验申请的实务导航

  • 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

Moderator:

Julia Leng Multitude Therapeutics

Platform Strategies: Designing Flexible Supply Chains for Multi-Modality Trials 平台化策略:为多模态临床试验设计灵活的供应链

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