TOXICOLOGY CONSULTING SERVICES FOR NINDS' HEAL PROGRAM

这项研究是NIH帮助结束成瘾长期(Hear)倡议的一部分，该倡议旨在加快科学解决方案，以了解疼痛的基础并加强临床疼痛管理。 承包商应向NIH Hear计划和其他NIH提供毒理学咨询服务 专注于神经科学的药物发现和开发计划。咨询服务包括： ·提供有关项目里程碑、目标产品简介和测试漏斗的意见。 ·就化学服务机构提出的化学结构和工艺提供反馈 每一轮结构-活动关系(SAR)的承包商。 ·按照签约官员代表的指示评估搜索结果数据。 ·毒理承包商(S)可能被要求评估潜在的易处理性(包括 围绕IP空间)用于毒理学的化学结构。具体的咨询职责 将视承包商的专业知识和个别项目的需要而定。 ·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 管理毒理学项目，以促进探索性化学、点击到领先、领先优化、 IND使能和临床研究。 ·担任确定潜在药物发现和开发的毒理学专家 挑战，并提出应对这些挑战的战略。 ·合作设计调查性研究，以支持NIH药物发现和 发展项目。 ·按照签约官员代表(COR)的要求，陪同NIH工作人员 访问合同研究组织(CRO)合同下的HERE计划， 检查设施，讨论CRO提出的方法的适当性，并提交 Trip向项目工作人员报告。 ·通过电话和电子邮件促进销售线索开发团队讨论分配的 毒理学方面的努力。

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. The Contractor shall provide toxicology consulting services to the NIH HEAL Program and to other NIH neuroscience-focused drug discovery and development programs. Consulting services include: • Providing input on project milestones, target product profiles, and testing funnels. • Providing feedback on chemical structures and processes proposed by a chemistry service contractor for each round of Structure-Activity Relationship (SAR). • Evaluating SAR data as directed by the Contracting Officer’s Representative (COR). • Toxicology Contractor(s) may be asked to evaluate the potential tractability (including surrounding IP space) of a chemical structure for toxicology. Specific consulting responsibilities will depend on the expertise of the Contractor and the needs of individual projects. • In partnership with other consultants, contractors, and the NIH staff, advise, strategically plan and manage toxicology programs to facilitate exploratory chemistry, hit-to-lead, lead optimization, IND enabling, and clinical studies. • Serving as the toxicology expert in identifying potential drug discovery and development challenges, and suggesting strategies to address these challenges. • Collaborating on design of investigative studies in support of NIH drug discovery and development projects. • As required by the Contracting Officer’s Representative (COR), accompanying NIH staff on visits to Contract Research Organizations (CRO) under contract to the HEAL Program, inspecting facilities, discussing appropriateness of CRO proposed methodology, and submitting trip reports to HEAL program staff. • Facilitating Lead Development Team discussions via telephone and email regarding assigned toxicology efforts.