TO PROVIDE THE NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE (NINDS) BLUEPRINT NEUROTHERAPEUTICS NETWORK (BPN) WITH PROCESS CHEMISTRY CONSULTANT SUPPORT SERVICES IN ACCORDANCE WITH THE GOVE

根据 GOVE 为国家神经疾病和中风研究所 (NINDS) 蓝图神经治疗网络 (BPN) 提供工艺化学顾问支持服务

• 批准号: 10653680
• 负责人: GIAN LUCA ARALDI
• 金额: $ 0.6万
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-20 至 2022-09-19
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10653680
• 关键词: Address; Biological Assay; Chemicals; Chemistry; Clinical; Clinical Research; Contractor; Contracts; Data; Development; Development Plans; Electronic Mail; Feedback; Guidelines; Knowledge; Lead; National Institute of Neurological Disorders and Stroke; Plants; Process; Protocols documentation; Regulation; Reporting; Research; Role; Services; Site; Strategic Planning; Technology Transfer; Testing; TimeLine; United States National Institutes of Health; Writing; innovative technologies; manufacturing process; manufacturing scale-up; member; pre-clinical; programs; scale up; small molecule; symposium; technology development

TO PROVIDE THE NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE (NINDS) BLUEPRINT NEUROTHERAPEUTICS NETWORK (BPN) WITH PROCESS CHEMISTRY CONSULTANT SUPPORT SERVICES Process Chemistry consultants will be expected to provide senior-level Process Chemistry 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 Process Chemistry consultant may include but is not limited to the following responsibilities and tasks: • Support process chemistry efforts of preclinical and clinical programs of the small molecules in development. Consultants may be asked to provide guidance on process endpoints, recommend assays and milestones to be incorporated into a testing funnel or development plan, and interpret data delivered by research service contractors. • In partnership with other consultants, contractors, and the NIH staff, advise, strategically plan, and manage process chemistry to support development of efficient and scalable manufacturing processes. • Provide expertise in process, scale up and implementation of innovative technologies, in support of IND enabling and clinical studies. • Serve as the process chemistry expert in order to identify potential developmental challenges and suggest strategies to address these challenges on realistic timelines. • Lead the chemical development activities including scale-up and process development from pilot-scale to commercial scale and technology transfer to commercial plants. • Manage the process development technology transfer of projects at contract manufacturing sites. • Oversee the writing of protocols for the manufacture of scale-up batches and associated process development reports. • Lead the process chemistry activities for compounds in development in accordance with the US regulatory and the ICH guidelines. • Evaluate manufacturing processes and changes, assessment of regulatory implications. • Maintain current knowledge of the relevant guidelines and regulations.

为国家神经疾病和中风研究所 (NINDS) 蓝图神经治疗网络 (BPN) 提供工艺化学顾问支持服务 过程化学顾问应提供高级过程化学专业知识，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。过程化学顾问的角色可能包括但不限于：以下职责和任务： • 支持正在开发的小分子临床前和临床项目的工艺化学工作，可能会要求顾问提供有关工艺终点的指导，建议纳入测试漏斗或开发计划的分析和里程碑，并解释研究服务提供的数据。承包商。 • 与其他顾问、承包商和 NIH 工作人员合作，提供建议、战略规划和管理工艺化学，以支持高效且可扩展的制造工艺的开发。 • 提供创新技术的流程、规模化和实施方面的专业知识，以支持 IND 实施和临床研究。 • 担任工艺化学专家，以确定潜在的发展挑战，并提出在现实的时间内应对这些挑战的策略。 • 领导化学品开发活动，包括从中试规模到商业规模的放大和工艺开发以及向商业工厂的技术转让。 • 管理合同制造工厂项目的工艺开发技术转让。 • 监督放大批次生产方案和相关工艺开发报告的编写。 • 根据美国法规和ICH 指南，领导正在开发的化合物的工艺化学活动。 • 评估制造流程和变更，评估监管影响。 • 保持对相关指南和法规的最新了解。