INDUS CORP:1108890 [19-007541]

承包商应为NIH蓝图神经治疗网络提供以下咨询支持服务： 毒理学 毒理学顾问将提供高级过程化学专业知识，并通过电话会议和电子邮件向NIH和LDT成员提供关于项目的反馈和指导。过程化学顾问的角色可能包括但不限于以下职责和任务： ·顾问可能被要求帮助建立一个项目的毒理学终点和里程碑，建议将化验纳入测试漏斗或开发计划，设计毒理学和药理学研究，并解释研究服务承包商提供的数据。 ·与其他顾问、承包商和NIH工作人员合作，提供建议、战略规划和管理项目，以促进领导优化、IND支持和临床研究。 ·作为资源，领导毒理学要求、药理学和后勤开发团队成员开展从临床前阶段到临床初始阶段的小分子化合物药物开发活动。 ·担任毒理学专家，以确定潜在的发展挑战，并提出应对这些挑战的战略。 ·合作设计调查性毒理学研究，以支持化合物的开发。 ·审查CRO[合同研究组织]或私人投资机构提供的监管文件中的毒理学部分[主要调查人员合作设计调查性研究，以支持化合物的开发。

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.