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 帮助结束成瘾长期 (HEAL) 计划的一部分，旨在加快科学解决方案的速度，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 SME 顾问将需要评估 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能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，例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 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 生物制品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，提供建议、战略规划和管理 PK/PD 和/ADME 计划，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) 支持神经疾病适当动物模型的体内功效研究设计 绩效领域 3：毒理学中小企业 毒理学中小企业顾问将需要提供高级专业知识，并通过电话会议和电子邮件向 NIH 和 LDT 成员提供项目反馈和指导。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，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、战略规划和管理项目，以促进先导化合物优化、IND 启用和临床研究 c) 作为 LDT 的毒理学要求、药理学和后勤资源，以开展从临床前阶段到初始临床阶段的生物制剂开发活动 d) 担任毒理学专家，以确定潜在的发育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的开发 f) 审查 CRO 或 PI 提供的监管文件的毒理学部分 g) 合作设计调查研究以支持生物制品的开发。 h) 为包括神经系统疾病在内的临床前策略制定提供专家支持 i) 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/离体的设计和解释 寡核苷酸筛选策略 k) 支持设计 PK/PD 和毒理学安全性研究 绩效领域 6 – 医学写作中小企业 医学写作 SME 顾问将负责为 NIH 生物制品计划准备和提交高质量的监管文件和其他支持文件。顾问将与 LDT 协调，在项目时间表内准备、编辑、审查文件并向监管机构（例如 FDA）提交文件。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。医学写作顾问的角色可能包括但不限于以下职责和任务： a) 独立或作为团队的一部分收集、编译、撰写和编辑监管文件以提交给监管机构 b) 确保提交的内容符合适用于 FDA 要求的格式和内容要求，并符合 ICH 指南 c) 管理监管提交的时间表 d) 独立完成分配的项目 e) 熟悉当前影响医学写作的最佳行业实践和监管要求 f) 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)