PHARMACEUTICS FORMULATION/CHEMISTRY MANUFACTURING AND CONTROL CONSULTING SERVICES FOR SMALL MOLECULES AND/OR BIOLOGICS

小分子和/或生物制剂的药物制剂/化学制造和控制咨询服务

• 批准号: 10788021
• 负责人: GIAN ARALDI
• 金额: $ 4.85万
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-02 至 2023-09-01
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10788021
• 关键词: Authorization documentation; Biological Products; Chemicals; Chemistry; Clinical Research; Conduct Clinical Trials; 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; Teleconferences; Telephone; United States National Institutes of Health; Visit; analytical method; assay development; authority; design; drug metabolism; lead optimization; manufacture; member; method development; product development; programs; small molecule

Pharmaceutics / Formulation / CMC Pharmaceutics / Formulation/ CMC consultants will be expected to provide executive (senior scientific)-level Pharmaceutics / Formulation/ CMC expertise and contribute feedback and guidance on projects to the NIH and to LDT members through video/teleconference calls and by email. The role of the Pharmaceutics / Formulation/CMC consultant may include but is not limited to the following responsibilities and tasks: 1. Evaluate Pharmaceutics / Formulation / CMC activities for BPN compounds under development in accordance with US regulatory and International Council of Harmonization for Registration of Pharmaceuticals for Human Use [ICH] guidelines. 2. Identify and assess regulatory risks for compounds under development and provide CMC guidance to BPN program and LDTs. Develop Pharmaceutics / Formulation / CMC strategies which accord with US and international guidelines. 3. Provide recommendations for drug substance manufacturing, analytical method development, and process development for small molecules. 4. Provide pharmaceutical sciences expertise in chemical manufacturing, formulation, and product development for small molecules. 5. Assist in ensuring timely preparation, review, and submission of chemical manufacturing and controls documents to regulatory authorities including FDA, European Medicines Agency [EMA] and other national authorities, to support the conduct of clinical trials and marketing applications. 6. Provide expertise in activities related to API development. 7. Recommend dose form selection and API development strategies for BPN efforts. 8. Develop plans to assist 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. 9. Accompany NIH staff or visit, at BPN staff request, Contract Research Organizations [CRO] under contract. Inspect facilities and discuss appropriateness of CRO proposed methodology. Submit trip reports to BPN staff. 10. Assist 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. 11. Facilitate Lead Development Team discussions via telephone and email regarding assigned drug metabolism and pharmacokinetics efforts.

制药/制剂/ CMC 药剂学/制剂/ CMC顾问将提供执行（高级科学）级别的药剂学/制剂/ CMC专业知识，并通过视频/电话会议和电子邮件向NIH和LDT成员提供项目反馈和指导。药剂学/制剂/CMC顾问的职责可能包括但不限于以下职责和任务： 1. 根据美国法规和人用药品注册国际协调理事会[ICH]指南，评价正在开发的BPN化合物的药剂学/制剂/ CMC活性。 2. 识别和评估正在开发的化合物的监管风险，并为BPN项目和LDT提供CMC指导。制定雅阁美国和国际指南的药剂学/配方/ CMC策略。 3. 为小分子原料药生产、分析方法开发和工艺开发提供建议。 4. 在化学品制造、配方和小分子产品开发方面提供制药科学专业知识。 5. 协助确保及时准备、审查并向监管机构（包括FDA、欧洲药品管理局[EMA]和其他国家机构）提交化学品生产和控制文件，以支持临床试验和上市申请的开展。 6. 提供API开发相关活动的专业知识。 7. 为BPN工作推荐剂型选择和API开发策略。 8. 制定计划，协助BPN员工战略性地管理化学品生产和控制药代动力学项目，以促进分析开发、探索性化学、先导化合物优化、制剂活动、研究性新药（IND）启用和临床研究。 9. 陪同NIH工作人员或根据BPN工作人员的要求访问合同研究组织[CRO]。检查设施并讨论CRO提议方法的适当性。向BPN员工提交出差报告。 10. 协助BPN人员设计研究性化学品生产和控制药代动力学研究，包括研究策略和实验设计。根据需要，提供关于推荐研究里程碑的建议并准备里程碑报告。 11. 通过电话和电子邮件促进首席开发团队讨论分配的药物代谢和药代动力学工作。