PHARMACEUTICS/FORMULATION/CMC CONSULTING SERVICES FOR NINDS HEAL PROGRAM

NINDS HEAL 计划的药剂/制剂/CMC 咨询服务

• 批准号: 10910957
• 负责人: STEPHEN ANDERSON
• 金额: $ 1.24万
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-29 至 2024-09-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10910957
• 关键词: Authorization documentation; Chemicals; Chemistry; Chronic; Clinical Research; Clinical Trials; Conduct Clinical Trials; Contractor; Contracts; Development; Dose; Drug Kinetics; Electronic Mail; Ensure; European; Experimental Designs; Feedback; Formulation; Guidelines; Helping to End Addiction Long-term; Hour; Human; International; Investigational Drugs; Knee Osteoarthritis; Lead; Marketing; Medicine; Methodology; National Institute of Neurological Disorders and Stroke; Neurosciences; Opiate Addiction; Pain; Pain management; Perioperative; Pharmaceutical Preparations; Pharmacologic Substance; Pharmacy (field); Preparation; Process; Program Development; Quality of life; Recommendation; Reporting; Research Contracts; Risk; Science; Services; Speed; Teleconferences; Telephone; Time; United States National Institutes of Health; Visit; Work; analytical method; assay development; authority; chronic musculoskeletal pain; clinical pain; design; drug development; drug discovery; drug metabolism; improved; lead optimization; manufacture; meetings; member; method development; novel; preclinical safety; product development; programs; small molecule; symposium

“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.

“这项研究是NIH的一部分，有助于结束长期（治愈）倡议，以加快科学解决方案，以了解疼痛的基础并增强临床疼痛管理。” 承包商应在协作中提供药品/配方/CMC咨询服务 NIH治疗计划以及其他NIH神经科学的药物发现的方式 开发计划在HEAL LEAS开发团队（LDT）任职时。 LDTS开会 每到两周大约通过Telececonference，每个LDT项目都可能需要 每周三到十个小时，包括会议和准备时间。 分配承包商的主要开发团队（LDT）可以从事许多项目 通过临床前安全阶段进行探索。一些项目可能会继续研究新的 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： •提供高级药品/配方/CMC专业知识，反馈和指导 通过电话会议和电子邮件来治愈计划人员和LDT成员的项目。 •评估药物 /配方 / CMC活动的治疗化合物 根据美国监管和国际协调理事会的发展 用于人类使用的药物注册[ICH]指南。 •确定和评估开发化合物的法规风险并提供CMC 治愈计划和LDT的指导。 •制定药品 /配方 / CMC策略，该战略与美国和国际 指南。 •提供药物制造，分析方法开发和 小分子的过程开发。 •提供化学制造，配方和产品的药物科学专业知识 小分子的开发。 •协助确保及时准备，审查和提交化学制造和 将文件控制到包括FDA，欧洲药品局（EMA）在内的监管机构 和其他国家当局，以支持临床试验和营销应用的行为。 •提供与活性药物成分（API）开发有关的活动的专业知识。 •为治疗努力推荐剂量的选择和API开发策略。 •制定计划以帮助治疗员工战略管理化学制造和控制 设施开发的药代动力学计划，探索性化学，铅 优化，公式活动，研究新药（IND）启用和临床 研究。 •应治疗人员的要求，陪同NIH员工或访问合同研究组织 （CRO）与Heal合同，检查CRO设施并讨论CRO的讨论 建议的方法。提交旅行报告以治愈员工。 •协助治疗人员设计研究化学制造和控制 药代动力学研究，包括研究策略和实验设计。提供建议 有关建议的学习里程碑，并根据需要准备里程碑报告。 •通过电话和电子邮件促进有关指定药物代谢和的电子邮件讨论 药代动力学工作。 这项研究是NIH的一部分，有助于长期（HEL）倡议结束成瘾，以加快科学解决方案，以了解疼痛的基础并增强临床疼痛管理。该计划的一部分为各种疼痛条件建立了新颖的治疗选择，以改善生活质量并减少阿片类药物的依赖性。该计划研究广泛的疼痛状况，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。