INDUS CORP:1108890 [19-007541]

兴业股份:1108890 [19-007541]

• 批准号: 10610296
• 负责人: STEVE DUDDY
• 金额: $ 1.85万
• 依托单位: INTEGRATED NONCLINICAL DE
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-20 至 2022-09-19
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10610296
• 关键词: Address; Biological Assay; Chemistry; Clinical; Clinical Research; Consult; Contractor; Data; Development; Development Plans; Electronic Mail; Feedback; Lead; Logistics; Pharmacology; Pharmacology Study; Pharmacology and Toxicology; Principal Investigator; Process; Research; Research Contracts; Resources; Role; Services; Strategic Planning; Testing; Toxicology; United States National Institutes of Health; design; drug development; lead optimization; member; pre-clinical; programs; small molecule; symposium

The Contractor shall provide consulting support services to the NIH Blueprint Neurotherapeutics Network as follows: Toxicology Toxicology consultants will be expected to provide senior-level Process Chemistry expertise and contribute feedback and guidance on projects to the NIH and to LDT members through conference calls and by email. The role of the Process Chemistry consultant may include but is not limited to the following responsibilities and tasks: • Consultants may be asked to help establish toxicology endpoints and milestones for a project, recommend assays to be incorporated into a testing funnel or development plan, design toxicology and pharmacology studies, and interpret data delivered by research service contractors. • In partnership with other consultants, contractors, and the NIH staff, advise, strategically plan, and manage programs to facilitate lead optimization, IND enabling, and clinical studies. • Serve as a resource to lead development team members for toxicology requirements, pharmacology and logistics to conduct drug development activities for small molecule compounds from the preclinical stage through to the initial clinical stage. • Serve as the toxicology expert in order to identify potential developmental challenges and suggest strategies to address these challenges. • Collaborate on design of investigative toxicology studies in support of development compounds. • Review toxicology sections of regulatory filings provided by CROs [Contract Research Organizations] or PIs [Principal Investigators Collaborate on the design of investigative studies in support of development compounds.

承包商应向NIH Blueprint Neurotherapeutics Network提供以下咨询支持服务： 毒理学 毒理学顾问将提供高级工艺化学专业知识，并通过电话会议和电子邮件向NIH和LDT成员提供有关项目的反馈和指导。工艺化学顾问的职责可能包括但不限于以下职责和任务： · 顾问可能会被要求帮助建立项目的毒理学终点和里程碑，建议将试验纳入测试漏斗或开发计划，设计毒理学和药理学研究，并解释研究服务承包商提供的数据。 · 与其他顾问，承包商和NIH工作人员合作，提供建议，战略规划和管理计划，以促进铅优化，IND启用和临床研究。 · 作为一种资源，领导开发团队成员的毒理学要求，药理学和物流，从临床前阶段到初始临床阶段进行小分子化合物的药物开发活动。 · 担任毒理学专家，以确定潜在的发展挑战，并提出应对这些挑战的策略。 · 协助设计毒理学研究，以支持化合物的开发。 · 审查CRO [合同研究组织]或PI [主要研究者]提供的监管文件的毒理学部分，合作设计研究性研究，以支持开发化合物。