BIOACTIVITY ASSAY DEVELOPMENT CONSULTANT SUPPORT SERVICES

生物活性检测顾问可能需要评估生物活性检测和 推荐策略和实验，以优化和/或验证用于 药物化学运动。生物活性检测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。美国国家卫生研究院可能 寻求顾问对设计和解释常用的 体外分析，如生化和基于细胞的分析。具体咨询 责任将取决于个别顾问的专业知识和 2016年4月15日第3页，共7页 个别项目。可能需要与化验相关的咨询服务 基于LDTS或基于LDTS。 生物活性检测顾问的角色可能包括但不限于 以下职责和任务： ·与其他顾问、承包商和NIH工作人员合作，提供建议， 战略性地规划和管理项目，以促进领导优化、INDENABLE研究和临床研究。 ·作为LDT的资源，满足化验要求和实施药物的后勤 小分子化合物在临床前阶段的开发活动 一直到最初的临床阶段 ·担任化验专家，以确定潜在的发展挑战 并提出应对这些挑战的战略建议。 ·协作对象

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