Global Medical Affairs Fertility, R&D Biopharma, Merck KGaA, Darmstadt, Germany.
Department of Development and Regeneration, Biomedical Sciences Group, KU Leuven (University of Leuven), Leuven, Belgium.
Biol Reprod. 2019 Dec 24;101(6):1140-1145. doi: 10.1093/biolre/ioz016.
Endometriosis is an important gynecological disease, affecting 10% of reproductive age women, and associated with pain, infertility, reduced quality of life, and high health economic cost. Except for ultrasound detection of ovarian endometriotic cysts, the gold standard for diagnosis is laparoscopy, leading to diagnostic delays of 5-10 years. Accurate noninvasive biomarkers are needed, especially for symptomatic women with a normal gynecological ultrasound, to triage them towards medical or surgical treatment and to monitor their treatment outcome. Such biomarkers are not available today, largely because the research focus has been on discovery, not on reproducibility and validation. Academia/industry partnerships can move this field forward by validation of promising markers, consensus on endometriosis phenotypes/controls and desirable accuracy (sensitivity/specificity). Such partnerships should increase the quality and reproducibility of target discovery work and foster global consensus on the use of relevant preclinical/animal models, if they are managed with complete (financial) transparency and with the aim to translate innovation into products benefiting patients. It is essential that mutual objectives are clarified between industry and academia partners including intellectual property policy, critical decision points, funding agreements, milestones and timelines, with a clear strategy for project termination/change of strategy, a restriction on publications till new discoveries have been patented, considering that a minority of novel findings can be translated into new therapeutic targets, diagnostics, or marketed products.
子宫内膜异位症是一种重要的妇科疾病，影响 10%的育龄妇女，与疼痛、不孕、生活质量下降和高健康经济成本有关。除了超声检测卵巢子宫内膜异位囊肿外，诊断的金标准是腹腔镜检查，导致诊断延迟 5-10 年。需要准确的非侵入性生物标志物，特别是对于妇科超声正常但有症状的妇女，以便对其进行分诊，选择药物治疗还是手术治疗，并监测其治疗效果。目前尚无此类生物标志物，主要是因为研究重点是发现，而不是可重复性和验证。学术界/工业界的合作可以通过验证有前途的标志物、对子宫内膜异位症表型/对照组和理想的准确性（敏感性/特异性）达成共识，从而推动该领域的发展。此类合作应提高目标发现工作的质量和可重复性，并促进全球对相关临床前/动物模型的使用达成共识，如果这些合作能够完全（财务）透明地进行，并以将创新转化为有益于患者的产品为目标。至关重要的是，应在行业和学术界合作伙伴之间明确相互目标，包括知识产权政策、关键决策点、资金协议、里程碑和时间表，并制定明确的项目终止/变更策略，在新发现获得专利之前限制出版物，因为少数新发现可以转化为新的治疗靶点、诊断方法或上市产品。
