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的一部分，有助于结束长期（治愈）倡议，以加快科学解决方案，以了解疼痛的基础并增强临床疼痛管理。” 性能区域2：PK/PD和ADME研究中小企业 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，并向NIH员工提供有关与PK/PD和ADME相关的里程碑的建议。非临床顾问的作用可能包括但不限于以下职责和任务： a）充当PK/PD和ADME专家，以确定潜在的药物发现和发展挑战，例如铅识别和铅开发，并提出解决这些挑战的策略 b）合作研究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 Biologics Development Projects的发现和翻译项目 c）与其他顾问，承包商和NIH员工合作，咨询，战略性计划和管理PK/ PD和/ ADME计划，以支持生物测定开发，铅优化，公式活动，IND启用和临床研究 d）在适当的神经疾病动物模型中支持体内效率研究设计 绩效区域3：毒理学中小企业 有毒理学中小企业顾问将有望通过电话会议和电子邮件向NIH提供高级专业知识，并向NIH和LDT成员提供有关项目的反馈和指导。顾问的作用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渠道或开发计划，设计毒理学和药理学研究，并解释CROS提供的数据。 b）与其他顾问，承包商和NIH员工合作，咨询，战略计划和管理计划，以促进铅优化，IND启用和临床研究 c）作为LDT的毒理学需求，药理学和物流的资源 d）充当毒理学专家，以确定潜在的发展挑战并提出解决这些挑战的策略 e）在支持生物制剂开发的研究毒理学研究设计上合作 f）审查CRO或PIS提供的监管文件的毒理学部分 g）在支持生物制剂开发方面的调查研究设计上合作。 h）提供临床前策略开发的专家支持，包括神经系统疾病 i）支持神经疾病的体外和体内模型开发 j）支持硅分析和体外/ Ex Vivo中的设计和解释 寡核苷酸的筛选策略 k）设计PK/PD和毒理学安全研究 绩效区域6 - 医学写作中小企业 医学写作中小企业顾问将负责NIH生物制剂计划的高质量监管和其他支持文件。顾问将与LDT协调，以准备，编辑，审查和提交文件在项目时间表中的监管机构（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（DMFS），研究人员声明（FDA 1572）和药物档案。医学写作顾问的作用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工作，以收集，编译，写作和编辑监管文件，以提交监管机构 b）确保符合ICH指南的提交符合适用于FDA要求的格式和内容要求 c）管理监管提交的时间表 d）独立工作以完成分配的项目 e）保持对影响医学写作的当前最佳行业实践和监管要求的熟悉 f）作为整体临床研究过程的一部分，在其他文档上审查和执行质量控制（QC）