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

工艺化学咨询服务。

• 批准号: 10721072
• 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 2023-09-19
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10721072
• 关键词: Address; Biological Assay; Chemicals; Chemistry; Clinical; Clinical Research; Consult; Contractor; Contracts; Data; Development; Development Plans; Electronic Mail; Feedback; Guidelines; Human Resources; 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.

为国家神经紊乱和中风研究所(NINDS)蓝图神经治疗网络(BPN)提供过程化学顾问支持服务 预计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成员提供关于项目的反馈和指导。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的临床前和临床项目的过程化学努力。可能会要求顾问提供有关流程终点的指导，建议将分析和里程碑纳入测试漏斗或开发计划，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，以支持高效和可扩展的制造过程的开发。 ·提供流程、扩大和实施创新技术方面的专业知识，以支持IND支持和临床研究。 ·担任过程化学专家，以确定潜在的发展挑战，并提出战略，以便在现实的时间表内应对这些挑战。 ·领导化学品开发活动，包括从中试到商业规模的扩大和工艺开发，以及向商业工厂转让技术。 ·管理合同制造现场项目的工艺开发技术转让。 ·监督生产放大批次和相关工艺开发报告的协议的编写。 ·根据美国法规和非物质文化遗产指南，领导正在开发的化合物的过程化学活动。 ·评估制造流程和变更，评估监管影响。 ·保持对相关准则和条例的最新了解。