TOXICOLOGY CONSULTING SERVICES FOR NINDS' HEAL PROGRAM

NINDS HEAL 计划的毒理学咨询服务

• 批准号: 10720991
• 负责人: MARCIE WOOD
• 金额: $ 1.47万
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-11-01 至 2022-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10720991
• 关键词: Address; Chemical Structure; Chemistry; Clinical Research; Consult; Contractor; Contracts; Data; Development; Electronic Mail; Feedback; Helping to End Addiction Long-term; Individual; Lead; Methodology; National Institute of Neurological Disorders and Stroke; Neurosciences; Pain; Pain management; Process; Program Development; Reporting; Research Contracts; Services; Speed; Strategic Planning; Structure-Activity Relationship; Telephone; Testing; Toxicology; United States National Institutes of Health; Visit; clinical pain; design; drug development; drug discovery; lead optimization; programs

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 shall provide toxicology consulting services to the NIH HEAL Program and to other NIH neuroscience-focused drug discovery and development programs. Consulting services include: • Providing input on project milestones, target product profiles, and testing funnels. • Providing feedback on chemical structures and processes proposed by a chemistry service contractor for each round of Structure-Activity Relationship (SAR). • Evaluating SAR data as directed by the Contracting Officer’s Representative (COR). • Toxicology Contractor(s) may be asked to evaluate the potential tractability (including surrounding IP space) of a chemical structure for toxicology. Specific consulting responsibilities will depend on the expertise of the Contractor and the needs of individual projects. • In partnership with other consultants, contractors, and the NIH staff, advise, strategically plan and manage toxicology programs to facilitate exploratory chemistry, hit-to-lead, lead optimization, IND enabling, and clinical studies. • Serving as the toxicology expert in identifying potential drug discovery and development challenges, and suggesting strategies to address these challenges. • Collaborating on design of investigative studies in support of NIH drug discovery and development projects. • As required by the Contracting Officer’s Representative (COR), accompanying NIH staff on visits to Contract Research Organizations (CRO) under contract to the HEAL Program, inspecting facilities, discussing appropriateness of CRO proposed methodology, and submitting trip reports to HEAL program staff. • Facilitating Lead Development Team discussions via telephone and email regarding assigned toxicology efforts.

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。