CHEMISTRY MANUFACTURING CONTROL [CMC] / PHARMACEUTICS / FORMULATION CONSULTANT SUPPORT SERVICES

化学制造控制 [CMC] / 制药 / 配方顾问支持服务

• 批准号: 10551178
• 负责人: MISHRA SOMNATH
• 金额: $ 0.69万
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-12-20 至 2022-12-19
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10551178
• 关键词: Chemicals; Chemistry; Clinical Research; Conduct Clinical Trials; Contractor; Contracts; Development; Dose; Drug Kinetics; Electronic Mail; Ensure; European; Experimental Designs; Feedback; Formulation; Guidelines; Human; International; Investigational Drugs; Lead; Marketing; Medicine; Methodology; Pharmaceutical Preparations; Pharmacologic Substance; Pharmacy (field); Preparation; Process; Recommendation; Reporting; Research Contracts; Risk; Role; Science; Services; Telephone; Time; United States Food and Drug Administration; United States National Institutes of Health; Visit; analytical method; assay development; authority; design; drug metabolism; lead optimization; member; method development; product development; programs; small molecule; symposium

The Contractor provides support services to the NIH Blueprint Neurotherapeutics Network for chemistry manufacturing control (CMC) / Pharmaceutics / Formulation CMC / Pharmaceutics / Formulation consultants provide senior-level CMC / Pharmaceutics / Formulation expertise and contribute feedback and guidance on projects to the National Institutes of Health (NIH) and to lead development team (LDT) members through conference calls and by email. The role of the CMC / Pharmaceutics / Formulation consultant may include but is not limited to the following responsibilities and tasks: • Evaluate CMC activities for Blueprint Neurotherapeutics (BPN) compounds under development in accordance with US regulatory and International Council of Harmonization for Registration of Pharmaceuticals for Human Use [ICH] guidelines. • Identify and assess regulatory risks for compounds under development and provide CMC guidance to BPN and LDTs. Develop CMC strategies which accord with US and international guidelines. • Provide recommendations for drug substance manufacturing, analytical method development, and process development for small molecules. • Provide pharmaceutical sciences expertise in chemical manufacturing, formulation, and product development for small molecules. • Assist in ensuring timely preparation, review, and submission of chemical manufacturing and controls documents to regulatory authorities including the Food and Drug Administration (FDA), European Medicines Agency [EMA] and other national authorities, to support the conduct of clinical trials and marketing applications. • Provide expertise in activities related to active pharmaceutical ingredient (API) development. • Recommend dose form selection and API development strategies for BPN efforts. • Develop plans to assist NIH BPN staff in strategically managing chemical manufacturing and controls pharmacokinetic programs which facilitate assay development, exploratory chemistry, lead optimization, formulation activities, investigational new drug (IND) enabling, and clinical studies. • Accompany NIH staff or visit, at BPN staff request, Contract Research Organizations [CRO] under contract with BPN. Inspect facilities and discuss appropriateness of CRO proposed methodology. Submit trip reports to BPN staff. • Assist NIH BPN staff to design investigative chemical manufacturing and controls pharmacokinetics studies, including study strategy and experimental design. Provide advice regarding recommended study milestones and prepare milestone reports as needed. • Facilitate Lead Development Team discussions via telephone and email regarding assigned drug metabolism and pharmacokinetics efforts.

承包商为NIH的化学制造控制(CMC)/制药/配方蓝图神经治疗网络提供支持服务 CMC/制药/配方顾问提供高级CMC/制药/配方专业知识，并通过电话会议和电子邮件向美国国立卫生研究院(NIH)和领导开发团队(LDT)成员提供关于项目的反馈和指导。CMC/制药/配方顾问的角色可能包括但不限于以下职责和任务： ·根据美国监管机构和国际人用药物注册协调理事会[ICH]指南，评估正在开发的蓝图神经疗法(BPN)化合物的CMC活动。 ·确定和评估正在开发的化合物的监管风险，并向BPN和LDT提供CMC指导。制定符合美国和国际准则的CMC战略。 ·为小分子药物制造、分析方法开发和工艺开发提供建议。 ·提供化学制造、配方和小分子产品开发方面的制药科学专业知识。 ·协助确保及时准备、审查和向包括食品和药物管理局(FDA)、欧洲药品管理局(EMA)和其他国家当局在内的监管机构提交化学品制造和控制文件，以支持进行临床试验和营销应用。 ·提供与活性药物成分(原料药)开发相关的活动方面的专业知识。 ·为BPN工作建议剂型选择和原料药开发战略。 ·制定计划，协助NIH BPN员工从战略上管理化学制造和控制药代动力学计划，以促进分析开发、探索性化学、先导优化、配方活动、研究性新药(IND)启用和临床研究。 ·陪同NIH工作人员或应BPN工作人员要求访问与BPN签订合同的合同研究组织[CRO]。检查设施并讨论CRO提出的方法的适当性。向BPN员工提交出差报告。 ·协助NIH BPN工作人员设计调查性化学制造和控制药代动力学研究，包括研究策略和实验设计。提供有关推荐研究里程碑的建议，并根据需要准备里程碑报告。 ·通过电话和电子邮件促进Lead开发团队就指定的药物代谢和药代动力学工作进行讨论。