On September 27-28, 2018 FDA and the Critical Path Institute's Transplant Therapeutics Consortium convened a public workshop entitled "Evidence-Based Treatment Decisions in Transplantation: The Right Dose & Regimen for the Right Patient/Individualized Treatment" to facilitate cooperative engagement of transplant community stakeholders, including pharmaceutical industry, academic researchers, clinicians, patients, and regulators to discuss methods to advance development of novel immunosuppressive drugs for use in solid organ transplantation. Day 1 focused on the utility of biomarkers in drug development, with considerations for seeking regulatory endorsement for use in clinical trials. Biomarkers add value to drug development by improving patient selection criteria, safety monitoring, endpoint selection, and more. Regulatory endorsement through the FDA Biomarker Qualification Program encourages the use of biomarkers in drug development by instilling confidence and consistency in biomarker interpretation across trials. Public-private partnerships or consortia allow stakeholders to share expertise, resources, and data in pursuit of biomarker qualification. Biomarkers relevant to pre-transplant risk assessment, early post-transplant care, and assessment of immune response, immunosuppressive drug efficacy, and graft function as discussed on day one of the workshop, are discussed.

中文翻译：

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使用生物标志物改善肾器官移植中免疫抑制药物的开发和结果：会议报告。

2018 年 9 月 27 日至 28 日，FDA 和关键路径研究所的移植治疗联盟召开了一个名为“移植中的循证治疗决策：适合患者/个体化治疗的正确剂量和方案”的公共研讨会，以促进移植社区的合作参与包括制药行业、学术研究人员、临床医生、患者和监管机构在内的利益相关者将讨论推进用于实体器官移植的新型免疫抑制药物开发的方法。第 1 天的重点是生物标志物在药物开发中的效用，并考虑寻求监管认可以用于临床试验。生物标志物通过改进患者选择标准、安全监测、终点选择等为药物开发增加价值。通过 FDA 生物标志物资格计划的监管认可，通过在试验中灌输对生物标志物解释的信心和一致性，鼓励在药物开发中使用生物标志物。公私合作伙伴关系或联盟允许利益相关者共享专业知识、资源和数据，以追求生物标志物资格。研讨会第一天讨论的与移植前风险评估、移植后早期护理、免疫反应评估、免疫抑制药物疗效和移植物功能相关的生物标志物进行了讨论。和数据以追求生物标志物资格。研讨会第一天讨论的与移植前风险评估、移植后早期护理、免疫反应评估、免疫抑制药物疗效和移植物功能相关的生物标志物进行了讨论。和数据以追求生物标志物资格。研讨会第一天讨论的与移植前风险评估、移植后早期护理、免疫反应评估、免疫抑制药物疗效和移植物功能相关的生物标志物进行了讨论。