BIOACTIVITY ASSAY DEVELOPMENT CONSULTANT SUPPORT SERVICES

生物活性测定开发顾问支持服务

• 批准号: 10495522
• 负责人: LISA MINOR
• 金额: $ 1.23万
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-23 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10495522
• 关键词: Address; Biochemical; Biological Assay; Cells; Clinical; Clinical Research; Consult; Consultations; Contractor; Development; Individual; Logistics; Pharmaceutical Chemistry; Resources; Role; Services; Strategic Planning; United States National Institutes of Health; Validation; assay development; base; design; drug development; experimental study; in vitro Assay; lead optimization; pre-clinical; programs; small molecule

Bioactivity Assay consultants may be required to evaluate bioactivity assays and recommend strategies and experiments to optimize and/or validate the assays for use in a medicinal chemistry campaign. Bioactivity Assay consultants may be asked to assist in the establishment of milestones related to assay optimization or validation. The NIH may seek guidance from consultants on the design and interpretation of commonly used in vitro assays, such as biochemical and cell-based assays. Specific consulting responsibilities will depend on the expertise of the individual consultant and the needs of April 15, 2016 Page 3 of 7 individual projects. Assay-related consultation services may be required on an ad hoc basis or on LDTs. The role of the Bioactivity Assay consultant may include but is not limited to the following responsibilities and tasks: • In partnership with other consultants, contractors, and NIH staff, advise, strategically plan, and manage programs to facilitate lead optimization, INDenabling studies, and clinical studies. • Serve as a resource to LDT for assay requirements and logistics to conduct drug development activities for small molecule compounds from the preclinical stage through to the initial clinical stage • Serve as the assay expert in order to identify potential developmental challenges and suggest strategies to address these challenges. • Collaborate o

生物活性测定顾问可能需要评估生物活性测定， 推荐策略和实验，以优化和/或验证用于 药物化学运动。生物活性测定顾问可能会被要求协助 建立与分析优化或验证相关的里程碑。NIH可能 请顾问就设计和解释常用的 体外测定，如生物化学和基于细胞的测定。具体咨询 责任将取决于个别顾问的专门知识和 2016年4月15日第3页，共7页 个别项目。可能需要临时的化验相关咨询服务 或基于LDT。 生物活性测定顾问的职责可能包括但不限于 以下职责和任务： ·与其他顾问，承包商和NIH工作人员合作，建议， 战略规划和管理项目，以促进电极导线优化、IND启动研究和临床研究。 ·作为LDT的分析要求和物流资源，以进行药物 临床前阶段小分子化合物的开发活动 直到临床初期 ·作为分析专家，以确定潜在的发展挑战 并提出应对这些挑战的策略。 ·协作o