Pharmacology and drug development core

药理学和药物开发核心

• 批准号: 8382005
• 负责人: Diane Heck
• 金额: $ 107.05万
• 依托单位: UNIV OF MED/DENT NJ-R W JOHNSON MED SCH
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-28 至 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8382005
• 关键词: Acute; Animal Model; Anti-Inflammatory Agents; Anti-inflammatory; Antioxidants; Archives; Biological Assay; Biology; Biometry; Bromine; Carbonates; Caring; Cell Culture Techniques; Centers of Research Excellence; Chemicals; Chlorine; Clinical Research; Clinical Trials; Collaborations; Community Health; Computer Simulation; Computer software; Consult; Data; Data Collection; Dependence; Dermal; Development; Devices; Diagnostic; Dose; Doxycycline; Drug Approval Processes; Drug Delivery Systems; Drug Formulations; Drug Industry; Drug Kinetics; Environmental Health; Epidemiology; Esters; Evaluation; Exposure to; Eye; Eye Injuries; Gelatinase B; Goals; Grant; Head; Health Sciences; Human Resources; Hydrogels; Hydrogen Sulfide; In Vitro; Indomethacin; Industry; Inflammation; Injury; Institutes; Internet; Investigational Drugs; Investigational New Drug Application; Laboratories; Lead; Lung; Lung diseases; MMP9 gene; Mechlorethamine; Medical; Medical Research; Modeling; Monitor; Mus; Mustard Gas; NIH Program Announcements; New York; Nitrogen; Organ Culture Techniques; Orphan Drugs; Oxidative Stress; Pathology; Pharmaceutical Chemistry; Pharmaceutical Preparations; Pharmacodynamics; Pharmacologic Substance; Pharmacology; Pharmacy (field); Pharmacy Schools; Phosgene; Placebos; Poison; Poisoning; Procedures; Prodrugs; Property; Radiation; Regulatory Affairs; Research; Research Institute; Research Personnel; Role; Screening procedure; Services; Skin; Solutions; Strategic Planning; System; Testing; Therapeutic; Therapeutic Uses; Thrombocytopenia; Time; Toxic effect; Toxicokinetics; Toxicology; Training; Universities; Vesicants; Work; Wound Healing; Writing; assay development; base; data integrity; data management; data sharing; drug candidate; drug development; drug discovery; experience; good laboratory practice; health practice; in vivo; medical schools; meetings; member; microbial alkaline proteinase inhibitor; model development; novel; pre-clinical; professor; programs; relational database; repository; research and development; response; scale up; school health; therapeutic development; vapor

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.

药理学和药物开发科学核心将由纽约医学院健康科学与实践学院环境健康科学系教授兼系主任兼流行病学、生物统计学和社区健康系代理主任Diane Heck博士领导。Heck博士是毒理学和环境健康方面的专家，并因其在化学毒性机制方面的工作而受到认可。她曾与 与药物化学家在药物发现和先导化合物优化方面有二十多年的合作经验。加入Heck博士开发团队的是Jules Mitchel博士，他是罗格斯大学药学院的兼职教授，也是TargetHealth的总裁，TargetHealth是一家专门从事法规事务、FDA互动和所有提交的全方位服务CRO。临床研究管理、生物统计学和数据管理、基于互联网的临床试验、医学写作、良好生产规范和其他支持服务， 制药业。他在药物、生物制剂、器械和诊断方面拥有广泛的制药经验，包括多次监管申报、多次FDA会议和IND/IDE申报以及战略规划。米切尔博士自成立以来一直与我们的中心合作，并在反ACT会议上发表演讲。核心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John Graham博士和罗格斯大学Earnest Mario药学院院长Christopher Molloy，以及约翰逊和约翰逊药物研究与开发有限责任公司炎症与肺部疾病前高级研究员/团队负责人。该中心还将得到来自UMDNJ的Michael Gallo博士的协助，他曾为眼部护理行业提供咨询，并将为推进我们的CouterACT中心开发的眼用水凝胶提供专业知识。 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（主要是硫芥、氮芥和机械相关制剂）而造成的伤害的治疗方法的发展。这包括检测开发，化合物评估和协助研究人员优先考虑候选药物。在上一个赠款期间制定的两项对策表明， 对芥子气损伤的皮肤（吲哚美辛-酯-碳酸盐前药）和眼损伤（多西环素负载水凝胶）具有有前途的活性;这些将通过CounterACT临床前开发机构（CPDF）进行进一步开发和IND使能研究。此外，核心将继续与强生制药研究所合作，推进TPOmp作为治疗硫芥和辐射诱导的血小板减少症的孤儿药进入IND。