DMPPK CONSULTING SERVICES FOR NINDS' HEAL PROGRAM

DMPK 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成员提供有关项目的反馈和指导。DMPK顾问的职责可能包括但不限于以下职责和任务： · 为项目里程碑、目标产品概要和测试漏斗提供输入 · 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开发挑战。提出应对这些挑战的战略建议。 · 与其他顾问和承包商合作，制定计划以协助NIH工作人员战略性地管理药代动力学项目，促进分析开发、探索性化学、先导化合物优化、制剂活动、研究性新药（IND）启用和临床研究。 · 协助NIH人员设计药代动力学研究，包括研究策略和实验设计，考虑预算限制。提供关于建议的研究里程碑的建议，并准备里程碑报告。 · 通过电话和电子邮件促进首席开发团队讨论分配的药物代谢和药代动力学工作。 · 分析和解释药代动力学药物发现，开发和转化项目的数据。 · 陪同NIH工作人员或应NINDS工作人员的要求访问与NINDS签订合同的合同研究组织[CRO]。检查设施并讨论CRO拟定方法的适当性。向NINDS工作人员提交旅行报告。 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。

DMPK 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.