DMPPK CONSULTING SERVICES FOR NINDS' HEAL PROGRAM

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“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.