PHARMACEUTICS/FORMULATION/CMC CONSULTING SERVICES FOR NINDS HEAL PROGRAM

“这项研究是NIH帮助结束长期成瘾（HEAL）计划的一部分，旨在加速科学解决方案，以了解疼痛的基础并加强临床疼痛管理。 承包商应提供药剂学/配方/CMC咨询服务， NIH HEAL计划和其他NIH神经科学重点药物发现的方式， 在HEAL Lead Development Teams（LDT）任职期间，LDT会议 通过电话会议，每一到两周大约两个小时，每个LDT项目可能需要 每周3至10小时，包括会议和准备时间。 承包商被分配到的领导开发团队（LDT）可能从事多个项目 从探索性到临床前安全性阶段。一些项目可能会进行新的研究 药物（IND）和临床试验阶段。 承包商的责任和任务可能包括但不限于以下内容： ·提供高级药剂学/配方/CMC专业知识，反馈和指导， 通过电话会议和电子邮件向HEAL计划工作人员和LDT成员提供项目。 ·在以下条件下评估HEAL化合物的药剂学/制剂/ CMC活性 根据美国法规和国际理事会的要求， 人用药品注册[ICH]指南。 ·识别和评估正在开发的化合物的监管风险，并提供CMC 指导医疗计划和LDT。 ·制定雅阁美国和国际标准的制药/制剂/ CMC战略 指南 ·为原料药生产、分析方法开发提供建议， 小分子的工艺开发。 ·提供化学品制造、配方和产品方面的制药科学专业知识 小分子的发展。 ·协助确保及时准备、审查和提交化学品生产和 向监管机构（包括FDA、欧洲药品管理局（EMA））提交的控制文件 和其他国家当局，以支持临床试验和上市申请的开展。 ·提供与活性药物成分（API）开发相关的专业知识。 ·为HEAL工作推荐剂型选择和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和控制 药代动力学计划，促进试验开发、探索性化学、铅 优化、制剂活动、研究性新药（IND）启用和临床 问题研究 ·应HEAL工作人员的要求，陪同NIH工作人员或访问合同研究组织 (CRO)根据与HEAL签订的合同，检查CRO设施，并讨论CRO的适当性 建议的方法。向HEAL员工提交行程报告。 ·协助HEAL员工设计调查化学品制造和控制 药代动力学研究，包括研究策略和实验设计。提供咨询 关于建议的研究里程碑，并根据需要编写里程碑报告。 ·通过电话和电子邮件促进LDT关于指定药物代谢的讨论， 药代动力学的努力。 这项研究是NIH帮助结束长期成瘾（HEAL）计划的一部分，旨在加速科学解决方案，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方案，以改善生活质量并减少阿片类药物依赖。 该计划研究了广泛的疼痛状况，包括慢性重叠疼痛状况，慢性肌肉骨骼疼痛，围手术期疼痛和膝关节骨关节炎。

“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.” The Contractor shall provide Pharmaceutics/Formulation/CMC consulting services in a collaborative manner to the NIH HEAL Program and to other NIH neuroscience-focused drug discovery and development programs while serving on HEAL Lead Development Teams (LDT). LDTs meet for approximately two hours every one to two weeks via teleconference and each LDT project may require between three and ten hours weekly, inclusive of meeting and preparation time. Lead Development Teams (LDT) to which the Contractor is assigned may work on a number of projects in the exploratory through preclinical safety stages. Some projects may proceed to investigational new drug (IND) and clinical trial stages. The Contractor’s responsibilities and tasks may include but are not limited to the following: • Provide senior level pharmaceutics/formulation/CMC expertise, feedback, and guidance on projects to HEAL Program staff and LDT members through conference calls and email. • 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 U.S. 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 active pharmaceutical ingredient (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 control pharmacokinetic programs which facilitate assay development, exploratory chemistry, lead optimization, formulation activities, investigational new drug (IND) enabling, and clinical studies. • At the request of HEAL staff, accompany NIH staff or visit Contract Research Organizations (CRO) under contract with HEAL, inspect CRO facilities, and discuss appropriateness of CRO proposed methodology. Submit trip reports to HEAL staff. • Assist HEAL staff in designing 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 LDT 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.