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Pharmacology and drug development core

Pharmacology and drug development core
药理学和药物开发核心
批准号:
8545532
负责人:
Diane Heck
金额:
$87.4万
依托单位国家:
美国
项目类别:
财政年份:
2006
资助国家:
美国
项目状态:
未结题
起止时间:
2006-09-28 至
关键词:
AcuteAnimal ModelAnti-Inflammatory AgentsAnti-inflammatoryAntioxidantsArchivesBiological AssayBiologyBiometryBromineCarbonatesCaringCell Culture TechniquesCenters of Research ExcellenceChemicalsChlorineClinical ResearchClinical TrialsCollaborationsCommunity HealthComputer SimulationComputer softwareConsultDataData CollectionDependenceDermalDevelopmentDevicesDiagnosticDoseDoxycyclineDrug Approval ProcessesDrug Delivery SystemsDrug FormulationsDrug IndustryDrug KineticsEnvironmental HealthEpidemiologyEstersEvaluationExposure toEyeEye InjuriesGelatinase BGoalsGrantHeadHealth SciencesHuman ResourcesHydrogelsHydrogen SulfideIn VitroIndomethacinIndustryInflammationInjuryInstitutesInternetInvestigational DrugsInvestigational New Drug ApplicationLaboratoriesLeadLungLung diseasesMMP9 geneMechlorethamineMedicalMedical ResearchModelingMonitorMusMustard GasNIH Program AnnouncementsNew YorkNitrogenOrgan Culture TechniquesOrphan DrugsOxidative StressPathologyPharmaceutical ChemistryPharmaceutical PreparationsPharmacodynamicsPharmacologic SubstancePharmacologyPharmacy (field)Pharmacy SchoolsPhosgenePlacebosPoisonPoisoningProceduresProdrugsPropertyRadiationRegulatory AffairsResearchResearch InstituteResearch PersonnelRoleServicesSkinSolutionsStrategic PlanningSystemTestingTherapeuticTherapeutic UsesThrombocytopeniaTimeToxic effectToxicokineticsToxicologyTrainingUniversitiesVesicantsWorkWound HealingWritingassay developmentbasedata integritydata managementdata sharingdrug candidatedrug developmentdrug discoveryexperiencegood laboratory practicehealth practicein vivomedical schoolsmeetingsmembermicrobial alkaline proteinase inhibitormodel developmentnovelpre-clinicalprofessorprogramsrelational databaserepositoryresearch and developmentresponsescale upschool healthscreeningtherapeutic developmentvapor

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中文摘要
翻译
药理学和药物开发科学核心将由Diane Heck博士领导,Diane Heck博士是纽约医学院健康科学与实践学院环境健康科学系教授兼主任,也是流行病学、生物统计学和社区健康系代理主任。Heck博士是毒物学和环境健康方面的专家,并因其在化学毒性潜在机制方面的工作而受到认可。她一直在合作中工作 与药物化学家在药物发现和领导优化方面有二十多年的经验。Jules Mitchel博士加入了Heck博士的开发团队,他是罗格斯药学院的兼职教授兼TargetHealth总裁,TargetHealth是一家专门从事监管事务、FDA互动和所有提交的全方位服务CRO。临床研究管理、生物统计和数据管理、基于互联网的临床试验、医学写作、良好生产实践和其他支持服务,以 制药业。他在药物、生物、设备和诊断方面拥有广泛的制药经验,包括多次提交监管报告、多次FDA会议和IND/IDE报告,以及战略规划。米切尔博士自中心成立以来一直与我们合作,并在反对抗会议上发表演讲。Core的主要合作者包括美国陆军化学防御医学研究所(USAMRICD)硫芥模型开发专家约翰·格雷厄姆博士和罗格斯大学欧内斯特·马里奥药学院院长克里斯托弗·莫洛伊,他曾担任强生药物研究和开发公司炎症和肺部疾病高级研究员/小组组长。CORE还将得到来自UMDNJ的Michael Gallo博士的协助,他曾为眼部护理行业提供咨询,并将提供由我们的CouterACT中心开发的推进眼部水凝胶的专业知识。 药理学和药物开发核心的总体作用是促进治疗因接触可能用于恐怖袭击的有毒化学品造成的伤害的治疗方法的进步,这些有毒化学品主要是硫磺芥末、氮芥末和与机械有关的制剂。这包括测试开发、化合物评估和协助调查人员确定待改进的候选药物的优先顺序。在上一次赠款期间制定的两项对策表明, 对硫磺芥末损伤皮肤(一种吲哚美辛-酯-碳酸盐前体药物)和眼睛损伤(多西环素加载水凝胶)具有良好的活性;这些将通过中和临床前开发基金(CPDF)进一步开发和促进工业研究。此外,Core将继续与强生药物研究所合作,将TPOMP推进为IND,作为治疗硫芥子气和辐射引起的血小板减少症的孤儿药物。
英文摘要
The Pharmacology and Drug Development Scientific Core will be headed by Dr. Diane Heck, Professor and Chair of the Department of Environmental Health Science and Acting Chair of the Department of Epidemiology, Biostatistics and Community Health in the School of Health Sciences and Practice at New York Medical College. Dr. Heck is an expert in Toxicology and Environmental Health and is recognized for her work on mechanisms underlying chemical toxicity. She has worked in collaboration with medicinal chemists for more than twenty years in drug discovery and lead optimization. Joining Dr. Heck in her Development Team is Dr. Jules Mitchel, an Adjunct Professor in the Rutgers School of Pharmacy and President of TargetHealth, a full service CRO specializing in Regulatory Affairs, FDA interactions and all submissions. Clinical Research Management, Biostatistics and Data Management, Internet-based Clinical Trials, Medical Writing, Good Manufacturing Practices and other support services to the pharmaceutical industry. He has broad base pharmaceutical experience in drugs, biologies, devices and diagnostics including multiple regulatory submissions, many FDA meetings and IND/IDE submissions, and strategic planning. Dr. Mitchel has been working with our Center since its inception and has presented talks at CounterACT meetings. Key collaborators for the Core include Drs. John Graham, an expert in sulfur mustard model development at the US Army Medical Research Institute of Chemical Defense (USAMRICD) and Christopher Molloy, Dean of the Earnest Mario School of Pharmacy at Rutgers University and a former Senior Research Fellow/Team Leader, Inflammation & Pulmonary Diseases, Johnson & Johnson Pharmaceutical Research and Development, LLC. The Core will also be assisted by Dr. Michael Gallo from UMDNJ who has consulted for the eye care industry and will provide expertise in advancing ocular hydrogels developed by our CouterACT Center. The overall role of the Pharmacology and Drug Development Core is to facilitate the advancement of therapeutics for treatment of injury resulting from exposure to toxic chemicals that could be used in a terrorist attack, principally sulfur mustard, nitrogen mustard and mechanistically related agents. This includes assay development, compound evaluation and assisting investigators to prioritize drug candidates to be advanced. Two countermeasures developed over the last grant period have demonstrated very promising activity against sulfur mustard wounded skin (an Indomethacin-Ester-Carbonate prodrug) and eye injuries (doxycycline loaded hydrogels); these will be advanced for further development and IND-enabling studies through the CounterACT Preclinical Development Facility (CPDF). In addition, the Core will continue working with J&J Pharmaceutical Research Institute to advance TPOmp into an IND as an orphan drug for the treatment of sulfur mustard and radiation-induced thrombocytopenia.
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Pharmacology and drug development core
Pharmacology and drug development core
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