NINDS, NIH BPN, NIH HEAL AND OTHER NIH NEUROSCIENCE-FOCUSED DRUG DISCOVERY AND DEVELOPMENT PROGRAMS WITH TOXICOLOGY CONSULTING SERVICES

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。 毒理学中小企业(S) 预计毒理学中小企业顾问将提供高级专业知识，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。顾问的作用可包括但不限于以下责任和任务： A)帮助建立项目的毒理学终点和里程碑，建议将生物测定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CRO提供的数据。 B)与其他顾问、承包商和NIH工作人员合作，提供建议、战略性计划和管理项目，以促进主导优化、IND支持和临床研究 C)作为LDT的毒理学要求、药理学和后勤资源，开展从临床前阶段到临床初期的生物剂开发活动 D)担任毒理学专家，以查明潜在的发展挑战并提出应对这些挑战的战略 E)合作设计调查性毒理学研究，以支持生物制品开发 F)审查CRO或私人投资机构提供的监管备案文件的毒理学部分 G)合作设计调查性研究，以支持生物制品的开发。 H)为临床前战略制定提供专家支助，包括神经疾病战略 一)支持神经系统疾病的体外和体内模型开发 J)支持计算机分析和体外/体外分析的设计和解释 寡核苷酸的筛选策略 K)支持设计PK/PD和毒理学安全研究

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. Toxicology SME(s) Toxicology SME consultants will be expected to provide senior-level 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 consultants may include but are not limited to the following responsibilities and tasks: a) Help establish toxicology endpoints and milestones for a project, recommend bioassays to be incorporated into a testing funnel or development plan, design toxicology and pharmacology studies, and interpret data delivered by CROs. b) 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 c) Serve as a resource to the LDT for toxicology requirements, pharmacology and logistics to conduct biologics development activities for biologics from the preclinical stage through to the initial clinical stage d) Serve as the toxicology expert in order to identify potential developmental challenges and suggest strategies to address these challenges e) Collaborate on design of investigative toxicology studies in support of biologics development f) Review toxicology sections of regulatory filings provided by CROs or PIs g) Collaborate on the design of investigative studies in support of biologics development. h) Provide expert support of preclinical strategy development including that for neurological diseases i) Support in vitro and in vivo model development for neurological disease j) Support design and interpretation of in silico analyses and in vitro/ ex vivo screening strategies for oligonucleotides k) Support of design PK/PD and toxicology safety studies