BIOLOGICS SUBJECT MATTER EXPERT (SME) 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。 绩效领域2：PK/PD和ADME研究中小企业(S) 中小企业顾问将被要求评估PK/PD和ADME研究方案和数据，协助研究设计，并就建立与PK/PD和ADME相关的里程碑向NIH工作人员提供建议。非临床顾问的角色可以包括但不限于以下职责和任务： A)担任PK/PD和ADME专家，以确定潜在的药物发现和开发挑战，如线索确定和线索开发，并提出应对这些挑战的战略 B)协作设计调查性PK/PD和ADME研究、PK/PD和ADME战略、实验设计、数据分析和解释，以支持NIH生物制品开发项目的发现和翻译项目 C)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PK/PD和/ADME计划，以促进生物分析开发、领导优化、配方活动、IND支持和临床研究 D)在适当的神经系统疾病动物模型中支持体内疗效研究设计 表演领域3：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 表演领域6-医学写作中小企业(S) 医疗写作中小企业顾问将负责为NIH生物制品项目准备和提交高质量的法规和其他支持文件。顾问将与LDTS协调，在项目时间表内准备、编辑、审查文件，并将文件提交给监管机构(例如FDA)。文件可能包括但不限于临床方案、IND应用、研究人员手册(IBS)、IND修正案、药物主文件(DMF)、研究人员声明(表FDA 1572)和药物档案。医疗写作顾问的角色可能包括但不限于以下职责和任务： A)独立工作或作为团队的一部分，收集、编译、编写和编辑提交给监管机构的监管文件 B)确保提交的材料符合符合非物质文化遗产准则的适用于FDA要求的格式和内容要求 C)管理监管提交的时间表 D)独立完成分配的项目 E)熟悉影响医疗写作的当前最佳行业做法和监管要求 F)审查和执行其他文件的质量控制(QC)，作为整个临床研究过程的一部分

“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.” Performance Area 2: PK/PD and ADME studies SME(s) SME consultants will be required to evaluate PK/PD and ADME study protocols and data, assist with study design, and advise NIH staff on the establishment of milestones related to PK/PD and ADME. The role of the nonclinical consultants may include, but is not limited to, the following responsibilities and tasks: a) Serve as the PK/PD and ADME expert in order to identify potential drug discovery and development challenges such as lead identification and lead development and suggest strategies to address these challenges b) Collaborate on design of investigative PK/PD and ADME studies, PK/PD and ADME strategy, experimental design, data analysis and interpretation for discovery and translational projects in support of NIH biologics development projects c) In partnership with other consultants, contractors, and the NIH staff, advise, strategically plan, and manage PK/PD and/ ADME programs to facilitate bioassay development, lead optimization, formulation activities, IND enabling, and clinical studies d) Support in vivo efficacy study design in appropriate animal models of neurological disease Performance Area 3: 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 Performance Area 6 – Medical Writing SME(s) Medical Writing SME consultants will be responsible for the preparation and submission of high-quality regulatory and other supporting documents for NIH biologics programs. The consultants will coordinate with LDTs to prepare, edit, review, and submit documents to regulatory agencies (e.g., FDA) within project timelines. Documents may include but are not limited to clinical protocols, IND applications, Investigator Brochures (IBs), IND Amendments, Drug Master Files (DMFs), Statement of Investigators (Form FDA 1572), and drug dossiers. The role of the Medical Writing consultant may include but is not limited to the following responsibilities and tasks: a) Work independently or as part of a team to gather, compile, write, and edit regulatory documents for submission to regulatory agencies b) Ensure that submissions meet format and content requirements applicable to FDA requirements in compliance with ICH guidelines c) Manage timelines for regulatory submissions d) Work independently to complete assigned projects e) Maintain familiarity with current best industry practices and regulatory requirements that affect medical writing f) Review and perform quality control (QC) on other documents as part of the overall clinical research process