BIOLOGICS SUBJECT MATTER EXPERT (SME) CONSULTING SERVICES

生物制品主题专家 (SME) 咨询服务

• 批准号: 10719224
• 负责人: DAINA VANAGS
• 金额: $ 1.07万
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-15 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10719224
• 关键词: ADME Study; Address; Affect; Amendment; Animal Model; Area; Biological Assay; Biological Products; Clinical; Clinical Protocols; Clinical Research; Consult; Contractor; Data; Data Analyses; Development; Development Plans; Electronic Mail; Ensure; Experimental Designs; Familiarity; Feedback; Formulation; Guidelines; Helping to End Addiction Long-term; In Vitro; Industry; Lead; Logistics; Medical; Neurological Models; Oligonucleotides; Pain; Pain management; Pamphlets; Performance; Pharmaceutical Preparations; Pharmacology; Pharmacology Study; Pharmacology and Toxicology; Preparation; Process; Protocols documentation; Quality Control; Research Design; Research Personnel; Resources; Role; Services; Speed; Strategic Planning; Study Subject; Testing; TimeLine; Toxicology; United States National Institutes of Health; Work; Writing; clinical pain; design; drug development; drug discovery; efficacy study; in silico; in vivo; in vivo Model; lead optimization; member; model development; nervous system disorder; pharmacokinetics and pharmacodynamics; pre-clinical; programs; safety study; screening; symposium

“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

“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。 性能领域2：PK/PD和ADME研究SME SME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。非临床顾问的职责可能包括但不限于以下职责和任务： a）、 担任PK/PD和ADME专家，以识别潜在的药物发现和开发挑战，如先导化合物识别和先导化合物开发，并提出应对这些挑战的策略 B） 合作设计研究性PK/PD和ADME研究、PK/PD和ADME策略、实验设计、数据分析和解释，以支持NIH生物制剂开发项目的发现和转化项目 c）、 与其他顾问、承包商和NIH工作人员合作，为PK/PD和/ ADME项目提供建议、战略规划和管理，以促进生物测定开发、先导化合物优化、制剂活动、IND启用和临床研究 d）、 支持在适当的神经系统疾病动物模型中进行体内疗效研究设计 性能领域3：毒理学SME 毒理学SME顾问将通过电话会议和电子邮件向NIH和LDT成员提供高级专业知识，并就项目提供反馈和指导。顾问的角色可能包括但不限于以下职责和任务： a）、 帮助建立项目的毒理学终点和里程碑，推荐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、战略规划和管理项目，以促进先导药物优化、IND启用和临床研究 c）、 作为LDT的毒理学要求、药理学和物流资源，从临床前阶段到初始临床阶段开展生物制剂的生物制剂开发活动 d）、 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策略 e）、 合作设计毒理学研究，以支持生物制剂开发 f）的 审查CRO或PI提供的监管文件的毒理学部分 g）的 合作设计调查性研究，以支持生物制剂的开发。 h）的 为临床前策略制定提供专家支持，包括神经系统疾病 （一） 支持神经系统疾病的体外和体内模型开发 j）、 支持计算机模拟分析和体外/离体分析的设计和解释 寡核苷酸的筛选策略 k）的 支持设计PK/PD和毒理学安全性研究 绩效领域6 -医学写作SME 医学写作SME顾问将负责为NIH生物制剂项目准备和提交高质量的监管和其他支持文件。顾问将与LDT协调，准备、编辑、审查并向监管机构提交文件（例如，FDA）。文件可能包括但不限于临床方案、IND申请、研究者手册（IB）、IND修正案、药物主文件（DMF）、研究者声明（FDA 1572表）和药物档案。医学写作顾问的职责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，汇编，编写和编辑监管文件，以提交给监管机构 B） 确保提交材料符合符合ICH指南中适用于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）、 熟悉影响医学写作的当前最佳行业实践和法规要求 f）的 作为整个临床研究过程的一部分，对其他文件进行审查和质量控制（QC）