PHARMACEUTICS/FORMULATION/CMC CONSULTING SERVICES FOR NINDS HEAL PROGRAM

NINDS HEAL 计划的药剂/制剂/CMC 咨询服务

• 批准号: 10664817
• 负责人: SOMNATH MISHRA
• 金额: $ 2.26万
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-11 至 2022-09-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10664817
• 关键词: Chemicals; Chemistry; Chronic; Clinical Research; Conduct Clinical Trials; Contracts; Development; Dose; Drug Kinetics; Electronic Mail; Ensure; European; Experimental Designs; Feedback; Formulation; Guidelines; Helping to End Addiction Long-term; Human; International; Investigational Drugs; Knee Osteoarthritis; Lead; Marketing; Medicine; Methodology; National Institute of Neurological Disorders and Stroke; Opiate Addiction; Pain; Pain management; Perioperative; Pharmaceutical Preparations; Pharmacologic Substance; Pharmacy (field); Preparation; Process; Quality of life; Recommendation; Reporting; Research Contracts; Risk; Role; Science; Speed; Telephone; Time; United States National Institutes of Health; Visit; analytical method; assay development; authority; chronic musculoskeletal pain; clinical pain; design; drug metabolism; improved; lead optimization; member; method development; novel; product development; programs; small molecule; symposium

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. CMC / Pharmaceutics / Formulation CMC / Pharmaceutics / Formulation consultants will be expected to provide senior-level CMC / Pharmaceutics / Formulation 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 CMC / Pharmaceutics / Formulation consultant may include but is not limited to the following responsibilities and tasks: • Evaluate Chemical Manufacturing and Controls [CMC] activities for 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 NINDS and LDTs. Develop 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 NINDS efforts. • Develop plans to assist NIH 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 NIH staff request, Contract Research Organizations [CRO] under contract with NIH. Inspect facilities and discuss appropriateness of CRO proposed methodology. Submit trip reports to NIH staff. • Assist NIH 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.

这项研究是美国国立卫生研究院帮助结束长期成瘾（HEAL）倡议的一部分，旨在加速科学解决方案，以了解疼痛的基础并加强临床疼痛管理。