ASSAY DEVELOPMENT CONSULTING SERVICES FOR NINDS' HEAL PROGRAM

1.生物活性测定 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 就常用的 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 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。 ·合作设计调查研究，以支持发展 化合物. 这项研究是NIH帮助结束长期成瘾（HEAL）计划的一部分，旨在加速科学解决方案，以了解疼痛的基础并加强临床疼痛管理。这是该计划的一部分，该计划为各种疼痛状况建立了新的治疗方案，以改善生活质量并减少阿片类药物依赖。 该计划研究了广泛的疼痛状况，包括慢性重叠疼痛状况，慢性肌肉骨骼疼痛，围手术期疼痛和膝关节骨关节炎。

1. Bioactivity Assay 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 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 on design of investigative studies in support of development compounds. This study is part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to understand the basis of pain and enhance clinical pain management. It’s part of the program that establishes novel treatment options for a variety of pain conditions to improve quality of life and reduce opioid dependency. The program studies a broad range of pain conditions, including chronic overlapping pain conditions, chronic musculoskeletal pain, perioperative pain, and knee osteoarthritis.