PHARMACEUTICS/FORMULATION/CMC CONSULTING SERVICES FOR NINDS HEAL PROGRAM

药剂学/制剂/ CMC

Pharmaceutics / Formulation / CMC Pharmaceutics / Formulation/ CMC consultants will be expected to provide senior-level Pharmaceutics / Formulation/ CMC 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 Pharmaceutics / Formulation/CMC consultant may include but is not limited to the following responsibilities and tasks: • Evaluate Pharmaceutics / Formulation / CMC activities for HEAL compounds under development in accordance with US regulatory and International Council of Harmonization for Registration of Pharmaceuticals for Human Use [ICH] guidelines. • Identify and assess regulatory risks for compounds under development and provide CMC guidance to HEAL program and LDTs. Develop Pharmaceutics / Formulation / CMC strategies which accord with US and international guidelines. • Provide recommendations for drug substance manufacturing, analytical method development, and process development for small molecules. • Provide pharmaceutical sciences expertise in chemical manufacturing, formulation, and product development for small molecules. • Assist in ensuring timely preparation, review, and submission of chemical manufacturing and controls documents to regulatory authorities including FDA, European Medicines Agency [EMA] and other national authorities, to support the conduct of clinical trials and marketing applications. • Provide expertise in activities related to API development. • Recommend dose form selection and API development strategies for HEAL efforts. • Develop plans to assist HEAL staff in strategically managing chemical manufacturing and controls pharmacokinetic programs which facilitate assay development, exploratory chemistry, lead optimization, formulation activities, investigational new drug (IND) enabling, and clinical studies. • Accompany NIH staff or visit, at HEAL staff request, Contract Research Organizations [CRO] under contract with HEAL. Inspect facilities and discuss appropriateness of CRO proposed methodology. Submit trip reports to HEAL staff. • Assist HEAL staff to design investigative chemical manufacturing and controls pharmacokinetics studies, including study strategy and experimental design. Provide advice regarding recommended study milestones and prepare milestone reports as needed. • Facilitate Lead Development Team discussions via telephone and email regarding assigned drug metabolism and pharmacokinetics efforts. 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.