PROCESS CHEMISTRY CONSULTING SERVICES. KEY PERSONNEL CONSULTANT: DR. GIAN ARALDI.

工艺化学咨询服务。

• 批准号: 10827835
• 负责人: GIAN ARALDI
• 金额: $ 0.47万
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-20 至 2024-09-19
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10827835
• 关键词: Address; Biological Assay; Chemicals; Chemistry; Clinical; Clinical Research; Contractor; Contracts; Data Analyses; Development; Development Plans; Electronic Mail; Feedback; Guidelines; Human Resources; Knowledge; Lead; National Institute of Neurological Disorders and Stroke; Plants; Process; Protocols documentation; Recommendation; Regulation; Reporting; Research; Role; Services; Site; Strategic Planning; Technology Transfer; Testing; United States National Institutes of Health; Writing; innovative technologies; manufacture; manufacturing process; manufacturing scale-up; member; pre-clinical; programs; scale up; small molecule; symposium; technology development; timeline

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.

为美国神经疾病和中风研究所（NINDS）神经治疗网络（BPN）提供过程化学咨询支持服务 过程化学顾问将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成员提供有关项目的反馈和指导。工艺化学顾问的职责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药物的临床前和临床项目的工艺化学工作。顾问可能会被要求提供有关过程终点的指导，推荐将纳入测试漏斗或开发计划的测定和里程碑，并解释研究服务承包商提供的数据。 · 与其他顾问，承包商和NIH工作人员合作，提供建议，战略规划和管理过程化学，以支持开发高效和可扩展的制造工艺。 · 提供创新技术的工艺、规模和实施方面的专业知识，以支持IND使能和临床研究。 · 作为工艺化学专家，识别潜在的发展挑战，并提出策略，以解决这些挑战的现实时间表。 · 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。 · 管理合同生产基地项目的工艺开发技术转移。 · 监督规模扩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指导原则，领导化合物开发的工艺化学活动。 · 评估生产工艺和变更，评估监管影响。 · 保持对相关指南和法规的最新了解。