NINDS BPN DMPK Consulting - Jiunn Lin IGF::CL::IGF

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。 该承包商提供药物代谢和药代动力学(DMPK)支持，同时在美国国立卫生研究院(NIH)蓝图神经疗法(BPN)领导开发团队(LDT)服务。LDT每一到两周通过电话会议召开大约两个小时的会议，每个 LDT项目每周可能需要三到十个小时，包括会议和准备时间。 预计承包商将以协作方式提供支持服务。领导开发团队 承包商被分配到可能在多个项目上工作，处于探索性到临床前安全阶段。 一些项目可能会进入新药研究和临床试验阶段。 承包商应为NIH蓝图神经治疗网络提供咨询支持服务 以下是： ·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。 ·制定计划，协助NIH BPN工作人员对促进化验的药代动力学方案进行战略性管理 开发、探索化学、先导优化、配方活动、研究新药(IND) 使能，和临床研究。 ·协助NIH BPN工作人员设计调查性药代动力学研究，包括研究策略和实验 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 Development团队关于指定药物代谢的讨论 和药代动力学方面的努力。 ·分析和解释药代动力学药物发现、开发和翻译项目的数据。

“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 provides drug metabolism and pharmacokinetics (DMPK) support while serving on National Institutes of Health (NIH) Blueprint Neurotherapeutics (BPN) Lead Development Teams (LDTs). 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. The Contractor is expected to provide support services in a collaborative way. Lead Development Teams the Contractor is assigned to may work on a number of projects in the exploratory through preclinical safety stages. Some projects may proceed to investigational new drug and clinical trial stages. The Contractor shall provide consulting support services to the NIH Blueprint Neurotherapeutics Network as follows: • Evaluate pharmacokinetics study protocols and data to identify potential drug discovery and development challenges. Recommend strategies to address these challenges. • Develop plans to assist NIH BPN 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 BPN staff to design investigative pharmacokinetics studies, including study strategy and experimental design. 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.