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Editorial [Hot Topic: De-risking the Discovery and Development of New Drugs from Bench to Clinic (Guest Editor: Sergey Ilyin)]

机译：社论[热门话题：从新药到临床的新药研发风险（来宾编辑：谢尔盖·伊林）

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The biopharmaceutical industry is facing challenges from increased generic competition, regulatory changes and other factors negatively impacting pharma economics. Industry is also presented with opportunities for improving overall research & development and business efficiency via de-risking development of novel drug candidates. Approaches to improve efficiency and decrease risk include in vitro and in vivo ADME (absorption, distribution, metabolism and excretion), biomarker-enabled development strategies, intelligent clinical trial design and overall risk management. ADME strategies to select and optimize drug candidates can significantly reduce PK-based failures in clinical trials, and more successfully predict drug-drug interaction potentials in the clinic. ADME strategies are reviewed in this issue by Balani et al. (Millenium Pharmaceuticals, Inc.). Biomarker approaches can facilitate transition between discovery, experimental medicine and full development and in some cases be a part of postmarketing activities. Biomarker methodologies include genomics, pharmacogenomics, proteomics, integrative strategies and molecular imaging. Pharmacogenomics and its role in discovery and development are discussed by Johnson et al. from Pfizer Global Research and Development. Integrative strategies, such as Functional Informatics, could incorporate several different technologies to cross validate findings. Genomics, proteomics and integrative strategies as they can be applied to clinical oncology biomarker discovery are reviewed by Belkowski and colleagues from the Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Noninvasive techniques are generally based on imaging modalities and include light imaging, CT, MRI, PET as well as different combinations of these modalities, for example PET/CT. Although all of these technologies can facilitate preclinical and clinical activities, it is beyond this issue to cover them in detail. PET provides an opportunity to non-invasively evaluate in vivo PK, receptor occupancy and pharmacodynamics (PD), and PK/PD, and could lead to a better prediction of dosing to be used in the clinic as well as to a reduction in the cost and duration of phase II clinical trials. It could also provide information to enhance our understanding of the mechanism(s) of action. PET technology provides an ability to complement with assays of therapeutic efficacy and potential adverse events. In diseases that are difficult to approach with traditional methods, PET will accelerate and improve compound development. PET technology is reviewed in this issue by Wang and Maurer from the Alza Corporation. Selection of the right dosing is of paramount importance for informed goo go decision in clinical development. Of equal importance is a well-conceived overall design of a clinical study. This is of particular importance to trials with high placebo response rate and Yang, Cusin, and Fava from the Depression Clinical and Research Program at the Massachusetts General Hospital discuss various strategies to address this problem in antidepressant trials. Finally, Martin Mackay and his co-authors from Pfizer talk about overall strategies (technology, organizational, etc.) to handle risk in drug discovery and development. This issue is comprised of well referenced up-to-date edited manuscripts from leaders in the pharmaceutical industry and academia.
机译：生物制药行业面临着来自仿制药竞争加剧，法规变化和其他对制药经济产生负面影响的挑战。通过降低新药候选药物的开发风险，行业还获得了改善整体研发和业务效率的机会。提高效率和降低风险的方法包括体外和体内ADME（吸收，分布，代谢和排泄），基于生物标志物的开发策略，智能临床试验设计和整体风险管理。选择和优化候选药物的ADME策略可显着减少临床试验中基于PK的失败，并更成功地预测临床中的药物相互作用。 Balani等人在本期中回顾了ADME策略。 （Millenium Pharmaceuticals，Inc.）。生物标志物方法可以促进发现，实验医学和全面开发之间的过渡，并且在某些情况下可以作为上市后活动的一部分。生物标志物的方法包括基因组学，药物基因组学，蛋白质组学，整合策略和分子成像。 Johnson等人讨论了药物基因组学及其在发现和开发中的作用。来自辉瑞全球研究与开发。诸如功能信息学之类的集成策略可以采用几种不同的技术来交叉验证发现。强生制药研究与开发有限公司的Belkowski及其同事对可用于临床肿瘤生物标志物发现的基因组学，蛋白质组学和整合策略进行了综述。非侵入性技术通常基于成像模态，并且包括光成像，CT，MRI，PET以及这些模态的不同组合，例如PET / CT。尽管所有这些技术都可以促进临床前和临床活动，但是详细介绍这些技术已经超出了这个问题。 PET为非侵入性评估体内PK，受体占有率和药效学（PD）以及PK / PD提供了机会，并可能导致更好地预测将用于临床的剂量以及降低成本以及II期临床试验的持续时间。它还可以提供信息，以增强我们对行动机制的理解。 PET技术提供了与治疗功效和潜在不良事件分析相补充的能力。在传统方法难以治疗的疾病中，PET将加速并改善化合物的开发。 Alza Corporation的Wang和Maurer在本期中对PET技术进行了评论。正确剂量的选择对于临床开发中明智/不可行的决定至关重要。同样重要的是临床研究的总体构思。这对于安慰剂反应率高的试验尤其重要，麻省总医院抑郁症临床与研究计划的Yang，Cusin和Fava讨论了在抗抑郁试验中解决该问题的各种策略。最后，马丁·麦凯（Martin Mackay）和他来自辉瑞（Pfizer）的合著者讨论了应对药物发现和开发风险的总体策略（技术，组织等）。本期由制药行业和学术界的领导者精心引用的最新编辑手稿组成。

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    《Current Topics in Medicinal Chemistry》 |2005年第11期|p.1031-1031|共1页
  • 作者

    Sergey Ilyin;

  • 作者单位

    Bioinformatics / Translational Technology Group LeaderJohnson&Johnson Pharmaceutical Research&Development, L.L.C.Welsh and McKean RdsPO Box 776Spring House, PA 19477-0776USA.;

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