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赛默飞(PPD):2026年全球医药研发动向报告:150位行业领导者洞见(英文版)(40页).pdf

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1、BALANCINGBALANCINGPRESSURE AND POSSIBILITYThe Pulse 2026Global R&D insights in pharmaceuticalsMethodology 4 Executive summary 8Detailed findings:Challenges,strategies and state of the industry 15Detailed findings:Patient-focused strategies 24Detailed findings:AI/ML in clinical development 28Detailed

2、 findings:Outsourcing 32Appendix 34Contents2The Pulse About The PulseThe future for drug developers is increasingly shaped by their ability to adopt innovative strategies and new technologies while navigating an environment marked by complexity and rapid change.Thats why the PPD clinical research bu

3、siness of Thermo Fisher Scientific surveyed 150 leaders at biotech and pharmaceutical organizations around the globe to assess trends in drug discovery and development.Respondents shared barriers to bringing drugs to market,innovations influencing progress,and perspectives on topics such as AI,patie

4、nt recruitment,the regulatory landscape and more.Now in its fourth year,The Pulse reveals a stark throughline:uncertainty has become the dominant backdrop for drug development.Many of the past years shifts economic pressures,evolving care models,regulatory recalibration and rising expectations to do

5、 more with less continue to reverberate.As companies shore up investments and reassess their portfolios,leaders are grappling with immense pressure to deliver in an environment where the ground keeps moving.Across this years data,a clear picture emerges.Drug developers are navigating shifting sands:

6、balancing long-term scientific ambition with short-term operational realities,confronting challenges that are becoming more intertwined and less predictable,and working to maintain momentum despite forces largely outside their control.The Pulse goes beyond the numbers to explore what this pervasive

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1. **核心挑战**:临床试验成本上升(55%)、患者招募困难(39%)和监管环境变化(35%)为前三大挑战,监管挑战较2024年显著上升(从第11位升至第3位)。 2. **研发趋势**:45%企业临床开发周期延长,主因是方案复杂(39%)、患者招募困难(31%)及监管要求(28%);97%企业采用创新设计、外包或AI/ML缩短周期。 3. **AI/ML应用**:平均每家企业已在13-14个领域应用AI/ML,主要用于运营(87%)、数据分析(85%)和药物设计(82%),但信任度(47%)和系统集成(36%)是主要障碍。 4. **患者策略**:58%企业聚焦提升入组率,52%改善患者留存,但仅13%认为目标达成“非常成功”;患者多样性方面,43%企业较两年前有所改善。 5. **行业方向**:60%认为行业方向正确,但40%担忧;47%将加速研发列为首要目标,29%优先控制成本。
**药研最大挑战?** **患者招募难在哪?** **AI如何加速研发?**
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