DCTD Drug Development Project Management

化学生物学联盟由NCI癌症治疗和诊断部门（DCTD）与癌症研究中心（CCR）和NCI主任办公室（OD）共同开发，以促进发现和开发治疗癌症的新药物。据设想，该联盟的启动将为探测复杂的信号通路提供尖端的化学工具，并将作为制定一流靶向治疗的起点。CBC将是一个化学生物学和分子肿瘤学接口的综合研究联盟，将与DCTD和CCR内的各种项目合作，建立一个小型生物技术关注规模的迭代癌症药物发现小组。CBC的目标是关注目前私营部门尚未满足的肿瘤学治疗需求。CBC的长期愿景是弥合NCI支持的基础科学研究和临床研究之间的差距，作为重新建立NCI作为创新癌症治疗发现领域的世界领导者的第一步。 为了应对这一挑战，并确保NCI重新成为国家癌症治疗发现竞技场中强大而灵活的参与者，我们建议在协调癌症药物发现方面开展国家努力，将学术和小型生物技术化学生物学和分子肿瘤学团体与NCI开发治疗计划（DTP）的后期药物开发资源结合起来。这一独特的努力将： 1.专注于新靶点的识别，以及新分子的开发，以询问这些靶点，并作为潜在药物可以通过重组的NCI治疗管道设计和测试的先导结构。这将通过建立一个由化学家，化学生物学家和分子肿瘤学家组成的联盟来实现，该联盟认识到在药物发现方面越来越需要高度跨学科和创造性的团队研究工作，这将推动NCI进入个性化治疗癌症医学的时代。这些团队将通过使用NCI合同、NCI-SAIC分包合同或NCI赠款机制获得资金，以最方便和最适合所需科学专业知识的方式组建。 2.建立一个迭代的药物发现工作，将合并当前NCI治疗研究活动的所有部分，以便加速将有前途的化学先导化合物开发成真正的临床候选药物 3.建立一个增强的、强大的药物管道，目标是在2009年第四季度生产一种新的临床药物，用于首次人体临床试验 本文概述的综合过程将使NCI能够通过巩固和协调治疗开发所需的基本化学和生物技术，最大限度地提高其在过去十年中对分子肿瘤学的投资回报。这一举措还将简化学术界和小企业的化学家和生物学家的治疗开发工作流程，加强科学基础设施，使其分子沿着整个药物开发管道进入首次人体临床试验。我们相信，NCI化学生物学联盟将提供新的战略方法，使NCI重新成为抗癌药物发现和开发的世界领导者。

The Chemical Biology Consortium is being developed by NCI's Division of Cancer Treatment and Diagnosis (DCTD), in conjunction with the Center for Cancer Research (CCR) and the NCI Office of the Director (OD) to facilitate the discovery and development of new agents to treat cancer. It is envisioned that initiation of this consortium will provide cutting-edge chemical tools for probing complex signaling pathways and will serve as the starting point for the elaboration of first-in-class targeted therapies. The CBC will be an integrated research consortium at the interface of chemical biology and molecular oncology that will, working with various programs within DCTD and CCR, establish an iterative cancer drug discovery group on the scale of a small biotechnology concern. The goal of the CBC will be to focus on unmet therapeutic needs in oncology that are not currently addressed by the private sector. The long-term vision of the CBC is to bridge the gap between basic scientific investigation and clinical research supported by the NCI as the first step in re-establishing the NCI as a world leader in the area of innovative cancer therapeutics discovery. To address this challenge and to ensure that NCI re-emerges as a strong and flexible player in the national cancer therapeutics discovery arena, we propose to develop a national effort in coordinated cancer drug discovery that unites academic and small biotechnology chemical biology and molecular oncology groups with the later-stage drug development resources of the NCI's Developmental Therapeutics Program (DTP). This unique effort will: 1. Focus on the identification of novel targets, and the development of new molecules to interrogate those targets and serve as lead structures around which potential drugs can be designed and tested by a restructured NCI therapeutics pipeline. This will be accomplished, in part, by establishing a consortium of chemists, chemical biologists, and molecular oncologists, formed in recognition of the increasing need for a highly interdisciplinary and creative team research effort in drug discovery, that will propel the NCI into the era of personalized therapeutic cancer medicine. These teams will be formed with funding through the use of NCI contracts, NCI-SAIC subcontracts, or NCI grants mechanisms, whichever is most expedient and appropriate to the scientific expertise required. 2. Establish an iterative drug discovery effort that will coalesce all segments of the current NCI therapeutics research activity, so that the development of promising chemical leads into bone fide clinical candidates can be accelerated 3. Build an enhanced, and robust drug pipeline with the goal of producing a new clinical agent for first-in-human clinical testing in the fourth quarter of 2009 The integrated process outlined here will allow NCI to maximize the return on its investment in molecular oncology over the past decade by consolidating and coordinating the essential chemical and biological technologies that are available and necessary for therapeutics development. This initiative will also streamline the therapeutics development workflow for chemists and biologists in academia and small business by enhancing the scientific infrastructure available to move their molecules along the entire drug development pipeline into first-in-human clinical trials. We believe that the NCI Chemical Biology Consortium will provide the new strategic approach that is required for NCI to re-establish itself as a world leader in anticancer drug discovery and development.