INDUS CORP:1108890 [19-007541]

兴业股份:1108890 [19-007541]

• 批准号: 10368759
• 负责人: STEVE DUDDY
• 金额: $ 10.18万
• 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/10368759
• 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.

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