Groothuis Patrick G, Guo Sun-Wei
1 Preclinical Department, Synthon Biopharmaceuticals bv, Nijmegen, the Netherlands.
2 Shanghai OB/GYN Hospital, Fudan University, Shanghai, China.
Reprod Sci. 2018 Sep;25(9):1318-1329. doi: 10.1177/1933719118785767. Epub 2018 Jul 1.
The pipelines of pharmaceutical companies are filled with thousands of promising new compounds for a plethora of indications. Yet, a close review of the drugs that have recently been in clinical trials quickly reveals that only a handful of drugs under evaluation in women with endometriosis can be genuinely qualified as truly innovative and breakthrough drugs. Why is there such an industry-wide lukewarm interest in drug research and development for endometriosis/adenomyosis? Why are pharmaceutical companies so reluctant to initiate programs or invest in academic research in endometriosis/adenomyosis? It is evident that a substantial part of the novel druggable targets originate from research in academia. However, only the pharmaceutical industry has the resources and expertise to bring drugs to patients. In other words, we are fully dependent on the pharmaceutical industry to bring new therapeutics to the market. The aim of this editorial is to make scientists from academia aware of the enormous complexity of the drug development process, the drivers that propel pharmaceutical companies to initiate new programs and to prioritize their portfolios, the value of intellectual property rights, and also about the importance of scientific rigor, predictive translational models, and biomarkers. At the same time, the pharmaceutical industry must be made aware of the enormous opportunity at hand, as the current patient population with endometriosis/adenomyosis is just the tip of the iceberg. We hope that the insights presented here will enable the endometriosis/adenomyosis research community to find ways to valorize their knowledge and attract the interest of the industry.
制药公司的研发管线中充斥着成千上万种针对众多适应症的有前景的新化合物。然而，仔细审视近期处于临床试验阶段的药物就会很快发现，在子宫内膜异位症女性中接受评估的药物里，只有少数几种能真正称得上是具有创新性和突破性的药物。为何整个行业对子宫内膜异位症/子宫腺肌病的药物研发兴趣不高？为何制药公司如此不愿启动相关项目或投资子宫内膜异位症/子宫腺肌病的学术研究？显然，相当一部分新的可成药靶点源自学术研究。然而，只有制药行业具备将药物推向患者的资源和专业知识。换句话说，我们完全依赖制药行业将新疗法推向市场。这篇社论的目的是让学术界的科学家们了解药物研发过程的巨大复杂性、推动制药公司启动新项目并对其产品组合进行优先级排序的驱动因素、知识产权的价值，以及科学严谨性、预测性转化模型和生物标志物的重要性。与此同时，必须让制药行业意识到眼前的巨大机遇，因为目前子宫内膜异位症/子宫腺肌病的患者群体只是冰山一角。我们希望这里阐述的见解能使子宫内膜异位症/子宫腺肌病研究界找到方法来提升其知识价值并吸引行业的关注。
