Sumitomo Pharma America, Marlborough, Massachusetts, USA.
Sanofi US, Bridgewater, New Jersey, USA.
Clin Pharmacol Ther. 2024 Aug;116(2):282-288. doi: 10.1002/cpt.3245. Epub 2024 Mar 22.
A recent industry perspective published in this journal describes the benefits received by drug companies from participation in the MIDD Pilot Program. Along with the primary objectives of supporting good decision-making in drug development, there were substantial savings in time and development costs. Furthermore, many sponsors reported qualitative benefits such as new learnings and clarity on MIDD strategies and methodology that could be applied to other development programs. Based on the success of the Pilot Program, the FDA recently announced the continuation of the MIDD Paired Meeting Program as part of the Prescription Drug User Fee Act (PDUFA VII). In this report, we describe the collective experiences of industry participants in the MIDD Program to date, including all aspects of the process from meeting request submission to follow-up actions. The purpose is to provide future participants with information to optimize the value of the MIDD Program.
近期本期刊登的一篇行业观点文章描述了制药公司参与药物研发中的中间结果和关键决策（MIDD）试点计划所获得的收益。除了支持药物开发中良好决策的主要目标外，该计划还在时间和开发成本方面带来了实质性的节省。此外，许多申办方报告了定性收益，例如在 MIDD 策略和方法方面的新认识和清晰性，这些收益可应用于其他开发项目。基于试点计划的成功，FDA 最近宣布将 MIDD 配对会议计划作为《处方药使用者付费法案》（PDUFA VII）的一部分继续进行。在本报告中，我们描述了迄今为止行业参与者在 MIDD 计划中的集体经验，包括从会议请求提交到后续行动的各个方面。目的是为未来的参与者提供信息，以优化 MIDD 计划的价值。
