PHARMACEUTICS/FORMULATION/CMC CONSULTING SERVICES FOR NINDS HEAL PROGRAM

药剂/制剂/CMC 药剂学/制剂/CMC 顾问将提供高级药剂学/制剂/CMC 专业知识，并通过电话会议和电子邮件向 NIH 和 LDT 成员提供项目反馈和指导。药剂学/制剂/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委员会[ICH] 指南，评估正在开发的HEAL 化合物的药剂学/配方/CMC 活动。 • 识别和评估正在开发的化合物的监管风险，并为HEAL 计划和LDT 提供CMC 指导。制定符合美国和国际准则的药剂/制剂/CMC 策略。 • 为小分子原料药生产、分析方法开发和工艺开发提供建议。 • 提供小分子化学制造、配方和产品开发方面的制药科学专业知识。 • 协助确保及时准备、审查并向监管机构（包括 FDA、欧洲药品管理局 [EMA] 和其他国家机构）提交化学品制造和控制文件，以支持临床试验和营销申请的进行。 • 提供与API 开发相关的活动的专业知识。 • 推荐用于HEAL 工作的剂型选择和API 开发策略。 • 制定计划协助HEAL 员工战略性地管理化学品生产并控制药代动力学计划，以促进分析开发、探索化学、先导化合物优化、制剂活动、研究性新药(IND) 启用和临床研究。 • 陪同 NIH 工作人员或根据 HEAL 工作人员的要求访问与 HEAL 签订合同的合同研究组织 [CRO]。检查设施并讨论 CRO 提议的方法的适当性。向 HEAL 工作人员提交旅行报告。 • 协助HEAL 工作人员设计研究性化学品生产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先导开发团队讨论指定的药物代谢和药代动力学工作。 这项研究是 NIH 帮助消除成瘾长期 (HEAL) 计划的一部分，旨在加快科学解决方案的速度，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新的治疗方案，以提高生活质量并减少阿片类药物依赖。 该项目研究广泛的疼痛状况，包括慢性重叠疼痛、慢性肌肉骨骼疼痛、围手术期疼痛和膝骨关节炎。

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.