The Boston Consulting Group, London, UK.
The Boston Consulting Group, Paris, France.
Clin Pharmacol Ther. 2019 Apr;105(4):886-898. doi: 10.1002/cpt.1354.
At the turn of the century, the pharmaceutical industry began a transition toward a focus on oncology, rare diseases, and other areas of high unmet need that required a new, more complex approach to drug development. For many of these disease states and novel approaches to therapy, traditional approaches to clinical trial design fall short, and a number of innovative trial designs have emerged. In light of these changes, regulators across the globe are implementing new programs to provide regular development program support, facilitate accelerated access, use real-world data, and use digital tools to improve patients' lives. Emerging market regulators are also focusing on simplifying their regulatory pathways via regional harmonization schemes with varying levels of ambition. These changes in the external environment imply that biopharma regulatory teams need to adapt and evolve, leveraging digital tools, data, and analytics, and positioning themselves as strategic advisors during development.
在世纪之交，制药行业开始向专注于肿瘤学、罕见病和其他高未满足需求领域转变，这需要对药物开发采用新的、更复杂的方法。对于许多这些疾病状态和新型治疗方法，传统的临床试验设计方法存在不足，因此出现了许多创新的试验设计。有鉴于此，全球监管机构正在实施新的计划，以提供常规的开发计划支持、促进加速准入、使用真实世界数据以及使用数字工具来改善患者的生活。新兴市场监管机构也通过具有不同雄心水平的区域协调计划来专注于简化其监管途径。外部环境的这些变化意味着生物制药监管团队需要适应和发展，利用数字工具、数据和分析，并在开发过程中定位自己作为战略顾问。
