PHARMACEUTICS/FORMULATION/CMC CONSULTING SERVICES FOR NINDS HEAL PROGRAM

药剂学/制剂/CMC 预计制药/配方/CMC顾问将提供高级制药/配方/CMC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。药剂学/配方/CMC顾问的角色可能包括但不限于以下职责和任务： ·根据美国监管机构和国际人用药品注册协调理事会准则，评估正在开发的HELL化合物的药剂学/配方/CMC活动。 ·确定和评估正在开发的化合物的监管风险，并为Heave计划和LDT提供CMC指导。制定符合美国和国际指南的药品/配方/CMC战略。 ·为小分子药物制造、分析方法开发和工艺开发提供建议。 ·提供化学制造、配方和小分子产品开发方面的制药科学专业知识。 ·协助确保及时准备、审查和向包括FDA、欧洲药品管理局[EMA]和其他国家当局在内的监管机构提交化学品制造和控制文件，以支持进行临床试验和营销应用。 ·提供与原料药开发相关的活动方面的专业知识。 ·为治疗工作推荐剂量形式选择和原料药开发战略。 ·制定计划，协助Hear员工从战略上管理化学制造和控制药代动力学计划，以促进分析开发、探索性化学、先导优化、配方活动、新药研究(IND)和临床研究。 ·陪同NIH工作人员或应Hear工作人员的要求访问与Hear签订合同的研究组织[CRO]。检查设施并讨论CRO提出的方法的适当性。向医护人员提交出差报告。 ·协助Health员工设计调查性化学制造和控制药代动力学研究，包括研究策略和实验设计。提供有关推荐研究里程碑的建议，并根据需要准备里程碑报告。 ·通过电话和电子邮件促进Lead开发团队就指定的药物代谢和药代动力学工作进行讨论。 这项研究是NIH帮助结束成瘾长期(Hear)倡议的一部分，该倡议旨在加快科学解决方案，以了解疼痛的基础并加强临床疼痛管理。这是该计划的一部分，该计划为各种疼痛状况建立了新的治疗选择，以提高生活质量和减少阿片类药物依赖。该项目研究范围广泛的疼痛状况，包括慢性重叠疼痛状况、慢性肌肉骨骼疼痛、围手术期疼痛和膝骨性关节炎。

Pharmaceutics / Formulation / CMC Pharmaceutics / Formulation/ CMC consultants will be expected to provide senior-level Pharmaceutics / Formulation/ CMC 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 Pharmaceutics / Formulation/CMC consultant may include but is not limited to the following responsibilities and tasks: • Evaluate Pharmaceutics / Formulation / CMC activities for HEAL compounds under development in accordance with US regulatory and International Council of Harmonization for Registration of Pharmaceuticals for Human Use [ICH] guidelines. • Identify and assess regulatory risks for compounds under development and provide CMC guidance to HEAL program and LDTs. Develop Pharmaceutics / Formulation / CMC strategies which accord with US and international guidelines. • Provide recommendations for drug substance manufacturing, analytical method development, and process development for small molecules. • Provide pharmaceutical sciences expertise in chemical manufacturing, formulation, and product development for small molecules. • 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. • Provide expertise in activities related to API development. • Recommend dose form selection and API development strategies for HEAL efforts. • Develop plans to assist HEAL 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. • Accompany NIH staff or visit, at HEAL staff request, Contract Research Organizations [CRO] under contract with HEAL. Inspect facilities and discuss appropriateness of CRO proposed methodology. Submit trip reports to HEAL staff. • Assist HEAL 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. • Facilitate Lead Development Team discussions via telephone and email regarding assigned drug metabolism and pharmacokinetics efforts. This study is part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to understand the basis of pain and enhance clinical pain management. It’s part of the program that establishes novel treatment options for a variety of pain conditions to improve quality of life and reduce opioid dependency. The program studies a broad range of pain conditions, including chronic overlapping pain conditions, chronic musculoskeletal pain, perioperative pain, and knee osteoarthritis.