DCTD Drug Development Project Management

DCTD 药物开发项目管理

• 批准号: 8654757
• 负责人: DAVID HEIMBROOK
• 金额: $ 2077.28万
• 依托单位: LEIDOS BIOMEDICAL RESEARCH, INC.
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-26 至 2018-09-25
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8654757
• 关键词: Academia; Address; Antineoplastic Agents; Area; Award; Biological; Biological Assay; Biology; Biotechnology; Businesses; Charge; Chemicals; Chemistry; Clinic; Clinical; Clinical Research; Clinical Trials; Complex; Contracts; Data; Development; Developmental Therapeutics Program; Division of Cancer Treatment and Diagnosis; Drug Discovery Groups; Ensure; Evaluation; Funding; Generations; Goals; Government; Grant; Human; Investigation; Investments; Joint Ventures; Joints; Lead; Malignant Neoplasms; Medicine; Mission; Molecular; Monitor; NCI Center for Cancer Research; New Agents; Office Management; Oncologist; Oncology Group; Patient Care; Pharmaceutical Chemistry; Pharmaceutical Preparations; Phase; Phase I Clinical Trials; Phenotype; Private Sector; Process; Research; Research Activity; Research Infrastructure; Research Support; Resources; Signal Pathway; Site; Staging; Structure; Structure-Activity Relationship; Synthesis Chemistry; Technology; Testing; Therapeutic; Therapeutic Human Experimentation; Vision; Work; analog; anticancer research; bone; cancer diagnosis; cancer therapy; clinical application; design; drug development; drug discovery; experience; flexibility; high throughput screening; innovation; molecular oncology; novel; oncology; programs; research clinical testing; screening; small molecule; therapeutic development; tool

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.

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，旨在促进新药物的发现和开发，治疗癌症。预计该联盟的启动将为探索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疗法的起点。 CBC 将成为化学生物学和分子肿瘤学交叉领域的一个综合研究联盟，将与 DCTD 和 CCR 内的各个项目合作，建立一个小型生物技术公司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解决的肿瘤学未满足的治疗需求。 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，作为重新确立 NCI 在创新癌症治疗发现领域的世界领导者地位的第一步。 为了应对这一挑战并确保 NCI 重新成为国家癌症治疗发现领域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全国性工作，将学术和小型生物技术、化学生物学和分子肿瘤学团体联合起来借助 NCI 发展治疗计划 (DTP) 的后期药物开发资源。这一独特的努力将： 1. 专注于新靶点的识别，以及新分子的开发来研究这些靶点，并作为先导结构，围绕该结构可以通过重组的 NCI 治疗管道来设计和测试潜在的药物。这将在一定程度上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，该联盟的成立是为了认识到药物发现领域对高度跨学科和创造性团队研究工作的日益增长的需求，这将推动 NCI 进入这样的时代个性化治疗癌症医学。这些团队的组建将通过 NCI 合同、NCI-SAIC 分包合同或 NCI 拨款机制提供资金，以最方便、最适合所需科学专业知识的方式提供资金。 2. 建立迭代药物发现工作，将当前 NCI 治疗研究活动的所有部分合并起来，从而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 年第四季度生产出用于首次人体临床试验的新临床药物 这里概述的综合流程将使 NCI 通过整合和协调治疗开发可用且必需的基本化学和生物技术，最大限度地提高过去十年在分子肿瘤学方面的投资回报。该计划还将通过加强可用于将其分子沿着整个药物开发流程转移到首次人体临床试验的科学基础设施，简化学术界和小型企业的化学家和生物学家的治疗开发工作流程。我们相信，NCI 化学生物学联盟将为 NCI 提供新的战略方法，帮助其重新确立抗癌药物发现和开发领域的世界领导者地位。