DMPPK CONSULTING SERVICES FOR NINDS' HEAL PROGRAM

为 NINDS 的 HEAL 计划提供 DMPPK 咨询服务

• 批准号: 10788062
• 负责人: RONALD FRANKLIN
• 金额: $ 6.3万
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-30 至 2023-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10788062
• 关键词: Address; Budgets; Chemistry; Chronic; Clinical Research; Contractor; Contracts; Data; Data Analyses; Development; Drug Kinetics; Electronic Mail; Experimental Designs; Feedback; Formulation; Helping to End Addiction Long-term; Investigational Drugs; Knee Osteoarthritis; Lead; Methodology; Mind; National Institute of Neurological Disorders and Stroke; Opiate Addiction; Pain; Pain management; Perioperative; Protocols documentation; Quality of life; Recommendation; Reporting; Research Contracts; Role; Services; Speed; Telephone; Testing; United States National Institutes of Health; Visit; assay development; chronic musculoskeletal pain; clinical pain; design; drug development; drug discovery; drug metabolism; improved; lead optimization; member; novel; programs; 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.” pain; DMPK consultants will be expected to provide senior-level DMPK 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 DMPK consultant may include but is not limited to the following responsibilities and tasks: • Offer input on project milestones, target product profiles, and testing funnels • Evaluate pharmacokinetics study protocols and data to identify potential drug discovery and development challenges. Recommend strategies to address these challenges. • In partnership with other consultants and contractors, develop plans to assist NIH staff in strategically managing pharmacokinetic programs which facilitate assay development, exploratory chemistry, lead optimization, formulation activities, investigational new drug (IND) enabling, and clinical studies. • Assist NIH staff to design investigative pharmacokinetics studies, including study strategy and experimental design bearing budget constraints in mind. Provide advice regarding recommended study milestones and prepare milestone reports are needed. • Facilitate Lead Development Team discussions via telephone and email regarding assigned drug metabolism and pharmacokinetics efforts. • Analyze and interpret data for pharmacokinetics drug discovery, development, and translational projects. • Accompany NIH staff or visit, at NINDS staff request, Contract Research Organizations [CRO] under contract to NINDS. Inspect facilities and discuss appropriateness of CRO proposed methodology. Submit trip reports to NINDS staff. 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。”疼痛; DMPK顾问将有望提供高级DMPK专业知识，并通过电话会议和电子邮件向NIH和LDT成员提供有关项目的反馈和指导。 DMPK顾问的作用可能包括但不限于以下职责： •提供项目里程碑，目标产品配置文件和测试渠道的输入 •评估药代动力学研究方案和数据，以确定潜在的药物发现和发育挑战。建议解决这些挑战的策略。 •与其他顾问和承包商合作，制定了计划，以帮助NIH员工战略管理药代动力学计划，这些计划设施开发，探索性化学，铅优化，配方奶粉活动，研究新药（IND）启用和临床研究。 •协助NIH员工设计调查性药代动力学研究，包括研究策略和实验设计轴承预算限制。提供有关建议的学习里程碑和准备里程碑报告的建议。 •通过电话和电子邮件促进有关指定的药物代谢和药代动力学工作的讨论。 •分析和解释药代动力学药物发现，开发和翻译项目的数据。 •陪同NIH的工作人员或访问Ninds员工请求，合同研究组织[CRO]符合NINDS的合同。检查CRO提出的方法的设施和讨论适当性。向Ninds员工提交旅行报告。 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。