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系统生物学、生物标志物、生物模拟和建模在简化药物研发中的有效整合。

Effective integration of systems biology, biomarkers, biosimulation and modelling in streamlining drug development.

作者信息

Krishna Rajesh, Schaefer Hans Guenter, Bjerrum Ole J

机构信息

Merck Research Laboratories, Merck & Co., Inc., 126 East Lincoln Avenue, Rahway, NJ, USA.

出版信息

Eur J Pharm Sci. 2007 May;31(1):62-7. doi: 10.1016/j.ejps.2007.02.003. Epub 2007 Feb 20.

DOI:10.1016/j.ejps.2007.02.003
PMID:17408933
Abstract

The European Federation of Pharmaceutical Sciences (EUFEPS) has long established itself as leaders in the field of interdisciplinary meetings to discuss issues that face drug development. It's ever popular and well attended "Optimizing Drug Development" series has tackled numerous issues, most recent of which have been drug interactions, getting the dose right, candidate selection, and biomarkers (Lesko et al., 2000; Rolan et al., 2003; Stanski et al., 2005; Tucker et al., 2001). Over a course of 3 productive days, the meeting on "Effective Integration of Systems Biology, Biomarkers, Biosimulation and Modelling in Streamlining Drug Development", held in Basel, Switzerland was jointly sponsored by EUFEPS, European Biosimulation Network of Excellence (BioSim), American College of Clinical Pharmacology (ACCP), European Centre of Pharmaceutical Medicine (ECPM), and Swiss Society of Pharmaceutical Sciences (SGRW). The meeting was focused on emerging aspects related to the quantitative understanding of underlying pathways in drug discovery and clinical development, i.e. moving from an empirical to a model-based, quantitative drug development process. The objectives of the meeting were: (1) to highlight the current state of the art on biomarkers (as they relate to quantitative fingerprinting of disease), systems biology, modelling and simulation; (2) to illustrate the applications of these emerging tools in increasing the efficiency and productivity of new drug development by case examples; (3) to understand the gaps in the technology and organizational implementations in governance, and (4) allow an opportunity for cross-disciplinary interaction, i.e., scientists with more theoretical and technical modelling and simulation expertise of the BioSim network and researchers experienced in applying modelling and simulation techniques in day-to-day drug development were drawn together. This report summarizes the outcome from this meeting.

摘要

欧洲药物科学联合会(EUFEPS)长期以来一直是跨学科会议领域的领导者,致力于讨论药物开发所面临的问题。其广受欢迎且参会人数众多的“优化药物开发”系列会议已探讨了诸多问题,其中最近的议题包括药物相互作用、确定正确剂量、候选药物选择以及生物标志物(Lesko等人,2000年;Rolan等人,2003年;Stanski等人,2005年;Tucker等人,2001年)。在瑞士巴塞尔举行的为期3天卓有成效的“系统生物学、生物标志物、生物模拟和建模在简化药物开发中的有效整合”会议,由EUFEPS、欧洲卓越生物模拟网络(BioSim)、美国临床药理学院(ACCP)、欧洲药物医学中心(ECPM)和瑞士药物科学协会(SGRW)联合主办。该会议聚焦于药物发现和临床开发中对潜在途径进行定量理解的新兴方面,即从经验性药物开发过程转向基于模型的定量药物开发过程。会议的目标是:(1)突出生物标志物(与疾病定量指纹图谱相关)、系统生物学、建模和模拟的当前技术水平;(2)通过实例说明这些新兴工具在提高新药开发效率和生产力方面的应用;(3)了解治理中技术和组织实施方面的差距;(4)提供跨学科互动的机会,即BioSim网络中具有更多理论和技术建模与模拟专业知识的科学家与在日常药物开发中应用建模与模拟技术的研究人员汇聚一堂。本报告总结了此次会议的成果。

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