DiMasi Joseph A, Kim Jennifer, Getz Kenneth A
1 Tufts Center for the Study of Drug Development, Tufts University School of Medicine, Tufts University, Boston, MA, USA.
Ther Innov Regul Sci. 2014 Jul;48(4):482-487. doi: 10.1177/2168479014521419.
During the past decade, high risk, cost, and inefficiency have driven pharmaceutical and biotechnology companies to enter into collaborative and shared innovation approaches, including mergers and acquisitions, joint development, and in-licensing. These approaches can interrupt the drug development process and affect program-level clinical and regulatory cycle times. To examine these potential impacts, detailed development histories were obtained for 289 new molecular and biologics entities that received FDA approval between 2000 and 2011. Approximately half the drugs analyzed had their clinical development activity interrupted by a collaborative or shared innovation approach, with in-licensing as the most common. The total duration (clinical plus approval phases) for interrupted development programs was 20% longer-an additional 14.8 months (median)-than that of uninterrupted development programs ( P < .05). Approval phase length differences between uninterrupted and interrupted programs were not statistically significant. The results of this study provide important benchmarks and new insights for portfolio planning, forecasting, and management.
在过去十年中，高风险、高成本和低效率促使制药和生物技术公司采用合作与共享创新方式，包括并购、联合开发和引进许可。这些方式可能会中断药物研发过程，并影响项目层面的临床和监管周期。为了研究这些潜在影响，我们获取了2000年至2011年间获得美国食品药品监督管理局（FDA）批准的289个新分子实体和生物制品实体的详细研发历史。分析的药物中约有一半的临床研发活动因合作或共享创新方式而中断，其中引进许可最为常见。中断研发项目的总时长（临床阶段加审批阶段）比未中断研发项目长20%，即多出14.8个月（中位数）（P < .05）。未中断和中断项目在审批阶段时长上的差异无统计学意义。本研究结果为投资组合规划、预测和管理提供了重要基准和新见解。
