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Safety biomarker applications in drug development

机译：安全生物标志物在药物开发中的应用

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Biomarkers are invaluable drug development tools to assess and monitor safety in early clinical trials especially when exposure margins are limiting for promising therapeutics. Although progress has been made towards identifying and implementing translational safety biomarkers for a number of organ toxicities such as kidney and liver, significant biomarker gaps still exist to monitor toxicities for testis, pancreas, etc. Several precompetitive consortia [e.g., Predictive Safety Testing Consortia (PSTC), Innovative Medicines Initiative (IMI)] are working with industry, academia, government, patient advocacy groups and foundations with a goal to qualify biomarkers such that they can be used in preclinical studies and clinical trials to accelerate drug development. This manuscript discusses the complexities of novel biomarker discovery, validation and international regulatory qualifications intended for clinical trial applications and shares specific examples from Pfizer Research and Development. As safety biomarkers become widely accepted and qualified by the regulatory agencies, they will increasingly be implemented in early clinical trials, play a key role in decision making and facilitate the progression of promising therapeutics from preclinical through clinical development.
机译：生物标记物是评估和监测早期临床试验安全性的宝贵药物开发工具，尤其是当暴露余量限制了有希望的治疗方法时。尽管在识别和实施针对多种器官毒性（例如肾脏和肝脏）的翻译安全性生物标记物方面已经取得了进展，但是仍然存在巨大的生物标记物空白，以监测睾丸，胰腺等的毒性。 PSTC，创新药物倡议（IMI）]正在与行业，学术界，政府，患者倡导团体和基金会合作，以期使生物标志物合格，以便将其用于临床前研究和临床试验以加速药物开发。本手稿讨论了旨在用于临床试验的新型生物标志物发现，验证和国际监管资格的复杂性，并分享了辉瑞研究与开发的特定示例。随着安全生物标记物被监管机构广泛接受和认证，它们将越来越多地用于早期临床试验中，在决策中起关键作用，并促进有前途的治疗剂从临床前发展到临床发展。

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