The pharmaceutical industry is a dynamic, science-driven business constantly under pressure to innovate and morph into a higher performing organization. Innovations can include the implementation of new technologies, adopting new scientific methods, changing the decision-making process, compressing timelines, or making changes to the organizational structure. The drivers for the constant focus on performance improvement are the high cost of R&D as well as the lengthy timelines required to deliver new medicines for unmet needs. Successful innovations are measured against both the quality and quantity of potential new medicines in the pipeline and the delivery to patients. In this special feature article, we share our collective experience implementing matrix-assisted laser desorption/ionization imaging mass spectrometry (MALDI IMS) technology as an innovative approach to better understand the tissue biodistribution of drugs in the early phases of drug discovery to establish pharmacokinetic-pharmacodynamic (PK-PD) relationships, as well as in the development phase to understand pharmacology, toxicology, and disease pathogenesis. In our experience, successful implementation of MALDI IMS in support of therapeutic programs can be measured by the impact IMS studies have on driving decision making in pipeline progression. This provides a direct quantifiable measurement of the return to the organization for the investment in IMS. We have included discussion not only on the technical merits of IMS study conduct but also the key elements of setting study objectives, building collaborations, data integration into the medicine progression milestones, and potential pitfalls when trying to establish IMS in the pharmaceutical arena. We categorized IMS study types into five groups that parallel pipeline progression from the earliest phases of discovery to late stages of preclinical development. We conclude the article with some perspectives on how we see MALDI IMS maintaining relevance and becoming further embedded as an essential tool in the constantly changing environment of the pharmaceutical industry.

中文翻译：

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成像质谱在药物发现和开发中的出现：通过推动决策产生影响

制药行业是一个充满活力、科学驱动的企业，不断面临创新和转型为更高绩效组织的压力。创新可以包括新技术的实施、采用新的科学方法、改变决策过程、压缩时间线或改变组织结构。持续关注性能改进的驱动因素是研发成本高，以及为未满足的需求提供新药所需的漫长时间。成功的创新是根据潜在新药的质量和数量以及交付给患者的情况来衡量的。在这篇专题文章中，我们分享了我们实施基质辅助激光解吸/电离成像质谱 (MALDI IMS) 技术的集体经验，作为一种创新方法，可以在药物发现的早期阶段更好地了解药物的组织生物分布，从而建立药代动力学-药效学 (PK-PD)关系，以及在开发阶段了解药理学、毒理学和疾病发病机制。根据我们的经验，支持治疗计划的 MALDI IMS 的成功实施可以通过 IMS 研究对推动管道进展决策的影响来衡量。这提供了对组织投资 IMS 的回报的直接量化衡量。我们不仅讨论了 IMS 研究实施的技术优点，还讨论了设定研究目标、建立合作、将数据集成到医学进展里程碑的关键要素，以及尝试在制药领域建立 IMS 时的潜在陷阱。我们将 IMS 研究类型分为五组，从发现的早期阶段到临床前开发的后期阶段平行进行管道进展。我们以一些观点来结束这篇文章，说明我们如何看待 MALDI IMS 如何保持相关性并进一步嵌入作为制药行业不断变化的环境中的重要工具。我们将 IMS 研究类型分为五组，从发现的早期阶段到临床前开发的后期阶段平行进行管道进展。我们以一些观点来结束这篇文章，说明我们如何看待 MALDI IMS 如何保持相关性并进一步嵌入作为制药行业不断变化的环境中的重要工具。我们将 IMS 研究类型分为五组，从发现的早期阶段到临床前开发的后期阶段平行进行管道进展。我们以一些观点来结束这篇文章，说明我们如何看待 MALDI IMS 如何保持相关性并进一步嵌入作为制药行业不断变化的环境中的重要工具。