Admin mod - LOWERY CREEK CONSULTING -CMC consulting services

制药/配方/ CMC顾问将提供高级制药/配方/ CMC专业知识，并通过电话会议和电子邮件向NIH和LDT成员提供项目反馈和指导。制剂/制剂/CMC顾问的角色可能包括但不限于以下职责和任务：

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: 1. 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. 2. 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. 3. Provide recommendations for drug substance manufacturing, analytical method development, and process development for small molecules. 4. Provide pharmaceutical sciences expertise in chemical manufacturing, formulation, and product development for small molecules. 5. 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. 6. Provide expertise in activities related to API development. 7. Recommend dose form selection and API development strategies for HEAL efforts. 8. Develop plans to assist BPN 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. 9. Accompany NIH staff or visit, at BPN staff request, Contract Research Organizations [CRO] under contract. Inspect facilities and discuss appropriateness of CRO proposed methodology. Submit trip reports to BPN staff. 10. Assist BPN 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. 11. Facilitate Lead Development Team discussions via telephone and email regarding assigned drug metabolism and pharmacokinetics efforts.