DMPPK CONSULTING SERVICES FOR NINDS' HEAL PROGRAM

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。 预计DMPK顾问将提供高级DMPK专业知识，并通过电话会议和电子邮件向NIH和LDT成员提供关于项目的反馈和指导。DMPK顾问的角色可能包括但不限于以下职责和任务： ·提供有关项目里程碑、目标产品简介和测试漏斗的意见 ·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开发挑战。建议应对这些挑战的策略。 ·与其他顾问和承包商合作，制定计划，协助NIH员工战略性地管理药代动力学计划，促进分析开发、探索性化学、铅优化、配方活动、研究性新药(IND)启用和临床研究。 ·协助NIH工作人员设计调查性药代动力学研究，包括考虑到预算限制的研究战略和实验设计。就推荐的研究里程碑提供建议，并准备里程碑报告。 ·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。 ·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工作人员，或应NINDS工作人员的要求，访问NINDS合同下的研究组织[CRO]。检查设施并讨论CRO提出的方法的适当性。向NINDS员工提交旅行报告。 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。

“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.” 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.