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
基本信息
- 批准号:10909761
- 负责人:
- 金额:$ 3万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:AddressBiological AssayBiological ProductsClinicalClinical ResearchCollaborationsContractorData AnalysesDevelopmentDevelopment PlansElectronic MailFeedbackIn VitroLogisticsNational Institute of Neurological Disorders and StrokeNeurosciencesOligonucleotidesPharmacologyPharmacology StudyPharmacology and ToxicologyProgram DevelopmentRecommendationResourcesRoleServicesStrategic PlanningTestingToxicologyUnited States National Institutes of Healthdesigndrug developmentdrug discoveryhealingin silicoin vivo Modellead optimizationmembermodel developmentnervous system disorderpharmacokinetics and pharmacodynamicspre-clinicalprogramssafety studyscreeningsymposium
项目摘要
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
毒理学中小企业(S)
预计毒理学中小企业顾问将提供高级专业知识,并通过电话会议和电子邮件向NIH和LDT成员提供关于项目的反馈和指导。顾问的作用可包括但不限于以下责任和任务:
A)帮助建立项目的毒理学终点和里程碑,建议将生物测定纳入测试漏斗或开发计划,设计毒理学和药理学研究,并解释CRO提供的数据。
B)与其他顾问、承包商和NIH工作人员合作,提供建议、战略性计划和管理项目,以促进主导优化、IND支持和临床研究
C)作为LDT的毒理学要求、药理学和后勤资源,开展从临床前阶段到临床初期的生物剂开发活动
D)担任毒理学专家,以查明潜在的发展挑战并提出应对这些挑战的战略
E)合作设计调查性毒理学研究,以支持生物制品开发
F)审查CRO或私人投资机构提供的监管备案文件的毒理学部分
G)合作设计调查性研究,以支持生物制品的开发。
H)为临床前战略制定提供专家支助,包括神经疾病战略
一)支持神经系统疾病的体外和体内模型开发
J)支持计算机分析和体外/体外分析的设计和解释
寡核苷酸的筛选策略
K)支持设计PK/PD和毒理学安全研究
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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{{ truncateString('STEVE DUDDY', 18)}}的其他基金
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:
10721114 - 财政年份:2022
- 资助金额:
$ 3万 - 项目类别:
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:
10721115 - 财政年份:2022
- 资助金额:
$ 3万 - 项目类别:
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 - 财政年份:2022
- 资助金额:
$ 3万 - 项目类别:
INTEGRATED NONCLINICAL DEVELOPMENT SOLUTIONS, INC.:1212619 [14-013436] IGF::CL::IGF
综合非临床开发解决方案有限公司:1212619 [14-013436] IGF::CL::IGF
- 批准号:
8950820 - 财政年份:2014
- 资助金额:
$ 3万 - 项目类别:
INTEGRATED NONCLINICAL DEVELOPMENT SOLUTIONS, INC.:1212619 [14-013436] IGF::CL::IGF
综合非临床开发解决方案有限公司:1212619 [14-013436] IGF::CL::IGF
- 批准号:
9053391 - 财政年份:2014
- 资助金额:
$ 3万 - 项目类别:
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