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

点击翻译按钮获取中文摘要

“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.