NINDS BPN/ Lowery Creek /CMC Consulting Services IGF::CL::IGF

NINDS BPN/ Lowery Creek /CMC 咨询服务 IGF::CL::IGF

• 批准号: 10329714
• 负责人: BETH BURNSIDE
• 金额: $ 2.8万
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-05-23 至 2022-05-22
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10329714
• 关键词: Chemicals; Clinical; Clinical Trials; Conduct Clinical Trials; Consult; Contracts; Development; Dose; Ensure; Formulation; Guidelines; Knowledge; Lead; Leadership; Logistics; Marketing; National Institute of Neurological Disorders and Stroke; Pharmaceutical Preparations; Pharmacologic Substance; Pharmacy (field); Preparation; Process; Regulation; Resources; Risk; Role; Science; Services; Time; United States National Institutes of Health; Visit; analytical method; authority; drug development; implementation process; manufacturing process; member; method development; pre-clinical; product development; small molecule

The consultant will serve as a resource to LDT members for the regulatory requirements, processes, and logistics to conduct drug development activities for small molecule compounds from the preclinical stage through to the initial clinical stage. The consultant may be asked to provide strategic guidance for chemical manufacturing and controls (CMC) regulatory activities necessary to enable preclinical drug product manufacturing, IND enabling studies, and clinical trials. The role of the CMC/Pharmaceutics consultant may include but is not limited to the following responsibilities and tasks: • Lead CMC activities for compounds in development, in accordance with the US regulatory and the ICH guidelines. • Provide expertise in drug substance manufacturing, analytical method development, and process development for small molecules. • Provide pharmaceutical sciences leadership in chemical manufacturing, formulation, and product development for small molecules. • Provide CMC guidance and strategy to LDTs, including identifying and assessing regulatory risks. • Ensure the timely preparation, review and submission of CMC documents to regulatory authorities including FDA, EMA and other national authorities, to support the conduct of clinical trials and marketing applications. • Ensure the compliance of CMC activities with applicable regulatory requirements. • Evaluate manufacturing processes and changes, assess regulatory implications and support process implementation. • Assist NIH with inspections and onsite visits with contract organizations. • Maintain current knowledge of the relevant guidelines and regulations and determine applicability to activities. • Provide expertise in dose form selection. • Provide expertise in API development and related activities.

该顾问将作为LDT成员的法规要求，流程和物流资源，从临床前阶段到初始临床阶段进行小分子化合物的药物开发活动。顾问可能会被要求为化学品生产和控制（CMC）监管活动提供战略指导，以实现临床前制剂生产、IND使能研究和临床试验。 CMC/药剂顾问的职责可能包括但不限于以下职责和任务： · 根据美国法规和ICH指导原则，领导开发中化合物的CMC活动。 · 提供原料药生产、分析方法开发和小分子工艺开发方面的专业知识。 · 在小分子化学品制造、配方和产品开发方面提供制药科学方面的领导地位。 · 为LDT提供CMC指导和策略，包括识别和评估监管风险。 · 确保及时准备、审查并向监管机构（包括FDA、EMA和其他国家机构）提交CMC文件，以支持临床试验和上市申请的开展。 · 确保CMC活动符合适用的法规要求。 · 评估生产工艺和变更，评估监管影响并支持工艺实施。 · 协助NIH与合同组织进行检查和现场访问。 · 保持对相关指南和法规的现有知识，并确定其对活动的适用性。 · 提供剂型选择方面的专业知识。 · 提供API开发和相关活动的专业知识。