NINDS, NIH BPN, NIH HEAL AND OTHER NIH NEUROSCIENCE-FOCUSED DRUG DISCOVERY AND DEVELOPMENT PROGRAMS WITH TOXICOLOGY CONSULTING SERVICES

NINDS、NIH BPN、NIH Heal 和其他 NIH 神经科学重点药物发现和开发计划以及毒理学咨询服务

• 批准号: 10909762
• 负责人: STEVE DUDDY
• 金额: $ 1.2万
• 依托单位: CERTARA USA, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-20 至 2024-09-19
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10909762
• 关键词: Address; Biological Assay; Biological Products; Clinical; Clinical Research; Collaborations; Contractor; Data Analyses; Development; Development Plans; Electronic Mail; Feedback; Helping to End Addiction Long-term; In Vitro; Logistics; National Institute of Neurological Disorders and Stroke; Neurosciences; Oligonucleotides; Pain; Pain management; Pharmacology; Pharmacology Study; Pharmacology and Toxicology; Program Development; Recommendation; Resources; Role; Services; Speed; Strategic Planning; Testing; Toxicology; United States National Institutes of Health; clinical pain; design; drug development; drug discovery; in silico; in vivo Model; lead optimization; member; model development; nervous system disorder; pharmacokinetics and pharmacodynamics; pre-clinical; programs; safety study; screening; 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. Toxicology SME(s) Toxicology SME consultants will be expected to provide senior-level 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 consultants may include but are not limited to the following responsibilities and tasks: a) Help establish toxicology endpoints and milestones for a project, recommend bioassays to be incorporated into a testing funnel or development plan, design toxicology and pharmacology studies, and interpret data delivered by CROs. b) In partnership with other consultants, contractors, and the NIH staff, advise, strategically plan, and manage programs to facilitate lead optimization, IND enabling, and clinical studies c) Serve as a resource to the LDT for toxicology requirements, pharmacology and logistics to conduct biologics development activities for biologics from the preclinical stage through to the initial clinical stage d) Serve as the toxicology expert in order to identify potential developmental challenges and suggest strategies to address these challenges e) Collaborate on design of investigative toxicology studies in support of biologics development f) Review toxicology sections of regulatory filings provided by CROs or PIs g) Collaborate on the design of investigative studies in support of biologics development. h) Provide expert support of preclinical strategy development including that for neurological diseases i) Support in vitro and in vivo model development for neurological disease j) Support design and interpretation of in silico analyses and in vitro/ ex vivo screening strategies for oligonucleotides k) Support of design PK/PD and toxicology safety studies

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。