Scripps Florida Product Development Partnership for smoking cessation therapeutic

佛罗里达斯克里普斯戒烟治疗产品开发合作伙伴

• 批准号: 8260903
• 负责人: Patrick Robert Griffin
• 金额: $ 12.45万
• 依托单位: SCRIPPS FLORIDA
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-30 至 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8260903
• 关键词: 2-cyclopentyl-5-(5-isoquinolylsulfonyl)-6-nitro-1H-benzo(D)imidazole; Abstinence; Academia; Accounting; Attention; Bioinformatics; Biological Markers; Boxing; Capital; Cardiovascular Diseases; Cessation of life; Chantix; Charge; Chronic; Clinical; Collaborations; Communities; Country; Databases; Development; Disease; Drug Formulations; Drug Industry; Epigenetic Process; Event; Florida; Foundations; Future; Generations; Grant; Health; Health Care Costs; Healthcare; Healthcare Systems; Income; Industry; Knowledge; Label; Literature; Lung diseases; Malignant neoplasm of lung; Marketing; Medicine; Mental Health; MicroRNAs; Mission; Molecular; National Institute of Drug Abuse; Nicotine Dependence; Peptide antibodies; Pharmaceutical Preparations; Pharmacotherapy; Phase; Phase II Clinical Trials; Phase III Clinical Trials; Placebos; Positioning Attribute; Process; Relapse; Reporting; Research; Research Institute; Research Personnel; Resources; Review Literature; Risk; Scientist; Services; Signal Transduction; Smoker; Smoking; Societies; Therapeutic; Tobacco; Tobacco Dependence; Tobacco Use Cessation; Tobacco smoking; Tobacco use; Translational Research; Untranslated RNA; World Bank; Zyban; base; burden of illness; combat; cost effective; drug discovery; economic impact; effective intervention; industry partner; information gathering; interest; meetings; member; mortality; new product development; novel; pre-clinical; product development; programs; research and development; small molecule; smoking cessation; symposium; technology development; therapeutic development; trend; web site

DESCRIPTION (provided by applicant): The burden of disease and negative economic impact of tobacco addiction on society is staggering. It is predicted that ~0.6 billion current smokers worldwide will die from smoking-related illnesses, such as chronic obstructive pulmonary disorder (COPD), lung cancer, and cardiovascular disease. The development of efficacious smoking cessation aids is considered the most cost-effective intervention possible within a modern health-care system. Although clinically efficacious, current smoking cessation agents have very limited utility. Indeed, there is considerable risk of relapse even when treated with the most efficacious medications currently available, Chantix and Zyban, which must also now carry "black box" warnings on their labeling because of reported serious mental-health events associated with their use. Pharmacotherapy is therefore an effective strategy to aid smoking cessation efforts, but there is a pressing need to develop safer and more effective therapeutics. Product Development Partnerships (PDPs) are a collaborative effort between academia, the pharmaceutical industry and charitable organizations that seek to discover, develop and deliver new medicines. PDPs bridge the gap between research and development for diseases for which there has traditionally been low priority in industry to develop effective therapeutics. The major advantage of the PDP mechanism for therapeutic development for smoking cessation with Scripps Florida as the Managing Partner (MP) is that it takes full advantage of our core mission at TSRI-Scripps Florida to develop medications to aid smoking cessation and combines this expertise with the scientific and financial resources of PDP partners. Therapeutics will include small molecules (novel and re-purposed, RNAs, peptides, antibodies, and novel formulations and delivery mechanisms). During the UH2 phase of the MITD, we will thoroughly explore the feasibility of establishing a successful PDP for the generation of new smoking cessation products. During the UH3 phase we will execute on the Milestones described below. The Milestones achieved during the UH2 phase of the MITD PDP are; 1) Construct a searchable bioinformatic database to prioritize targets for therapeutic development. We will then report our findings using the database, along with all available scientific and strategic information on drug discovery in tobacco addiction, as a most comprehensive review of the nicotine addiction discovery process; and 2) We will organize a symposium, in conjunction with NIDA program staff, at a major scientific meeting (SRNT or CPDD) and FDA to discuss current clinical endpoints, and the potential and utility for developing biomarkers. We will also host a 2-day summit at TSRI-Scripps Florida to which all awardees of UH2 phase grants, NIDA program officials, leading academic scientists, established and perspective industry partners who may join the PDP, representatives from charitable foundations charged with combating tobacco addiction and smoking- associated disorders, and officials from the State of Florida Department of Health. At the end of this summit, we will identify the optimal partnerships to successfully drive the mission of the MITD PDP. The milestones achieved during the UH3 phase of the MITD PDP are: 1) We will fill a robust preclinical/clinical discovery pipeline based on findings during the UH2 phase; 2) By year 3 of the UH3, we will have 1 compound entering Phase II clinical trials; and 3) By year 5 of the UH3, we will have 1 compound entering Phase III clinical trials, and another 1-2 compounds entering Phase II clinical trials. PUBLIC HEALTH RELEVANCE: The burden of disease and negative economic impact of tobacco addiction on society is staggering. It is predicted that ~0.6 billion current smokers worldwide will die from smoking-related illnesses, such as chronic obstructive pulmonary disorder (COPD), lung cancer, and cardiovascular disease. Indeed, if current trends in tobacco use persist, by 2020 smoking will become the largest single health problem worldwide, causing ~8.4 million deaths annually. The World Bank estimates that in high-income countries, smoking-related healthcare accounts for between 6-15% of all healthcare costs, ~$160 billion annually. Smokers who quit before the onset of tobacco-related illness can largely avoid the increased mortality risk. Nevertheless, ~80% of smokers currently attempting to quit will relapse within the first month of abstinence. The development of efficacious smoking cessation aids is considered the most cost-effective intervention possible within a modern health-care system. Product Development Partnerships (PDPs) are a collaborative effort between academia, the pharmaceutical industry and charitable organizations that seek to discover, develop and deliver new medicines. PDPs bridge the gap between research and development for diseases for which there has traditionally been low priority in industry to develop effective therapeutics (small market size etc).

描述（由申请人提供）：疾病负担和烟草成瘾对社会的负面经济影响令人震惊。据预测，全球目前约6亿目前的吸烟者将死于与吸烟有关的疾病，例如慢性阻塞性肺部疾病（COPD），肺癌和心血管疾病。有效的戒烟艾滋病的发展被认为是现代卫生保健系统中最具成本效益的干预措施。尽管临床有效，但目前的戒烟剂的实用性非常有限。的确，即使使用当前可用的最有效的药物，Chantix和Zyban也有重大复发的风险，由于据报道与使用相关的严重心理健康事件，Chantix和Zyban现在也必须在其标签上发出“黑匣子”警告。因此，药物治疗是帮助戒烟工作的有效策略，但迫切需要开发更安全，更有效的治疗疗法。产品开发合作伙伴关系（PDP）是学术界，制药行业与寻求发现，开发和提供新药物的慈善组织之间的合作努力。 PDP弥合了研究和发展之间的疾病差距，而这些疾病传统上在行业方面一直优先考虑开发有效的治疗疗法。 PDP机制用于与Scripps Florida戒烟的PDP机制的主要优势是，作为管理合作伙伴（MP），它充分利用了我们在佛罗里达州TSRI-SCRIPPS佛罗里达州的核心使命，以开发有助于戒烟的药物，并将这种专业知识与PDP合作伙伴的科学和财务资源相结合。治疗剂将包括小分子（新颖和重新组合，RNA，肽，抗体以及新型制剂和递送机制）。在MITD的UH2阶段，我们将彻底探讨建立成功生成新的戒烟产品的PDP的可行性。在UH3阶段，我们将在下面描述的里程碑上执行。在MITD PDP的UH2阶段实现的里程碑是； 1）构建可搜索的生物信息学数据库，以优先考虑治疗开发目标。然后，我们将使用数据库报告我们的发现，以及有关烟草成瘾中药物发现的所有可用科学和战略信息，作为对尼古丁成瘾发现过程的最全面的评论； 2）我们将在一次大型科学会议（SRNT或CPDD）和FDA上与NIDA计划人员一起组织研讨会，以讨论当前的临床终点，以及开发生物标志物的潜力和实用性。我们还将在佛罗里达州TSRI-SCRIPPS举办为期2天的峰会，所有获奖者的所有获奖者，NIDA计划官员，领先的学术科学家，建立了观点行业合作伙伴，他们可能会加入PDP，来自PDP的代表，慈善基金会的代表，负责与托巴科·康斯科成瘾和吸烟相关的疾病和官员的官员和佛罗里达州的官员。在此峰会结束时，我们将确定成功推动MITD PDP任务的最佳合作伙伴关系。 MITD PDP的UH3阶段所达到的里程碑是：1）我们将根据UH2阶段的发现填充坚固的临床前/临床发现管道； 2）到UH3的第3年，我们将有1个化合物进入II期临床试验； 3）到UH3的第5年，我们将有1种进入III期临床试验的化合物，另外1-2个化合物进入了II期临床试验。 公共卫生相关性：疾病的负担和烟草成瘾对社会的负面经济影响令人震惊。据预测，全球目前约6亿目前的吸烟者将死于与吸烟有关的疾病，例如慢性阻塞性肺部疾病（COPD），肺癌和心血管疾病。确实，如果当前使用烟草使用的趋势持续存在，到2020年，吸烟将成为全球最大的单一健康问题，每年造成840万人死亡。世界银行估计，在高收入国家，与吸烟相关的医疗保健占所有医疗保健费用的6-15％，每年约为1600亿美元。在与烟草相关疾病发作之前戒烟的吸烟者可以在很大程度上避免死亡率增加。然而，目前约有80％的吸烟者试图退出，将在禁欲的第一个月内复发。有效的戒烟艾滋病的发展被认为是现代卫生保健系统中最具成本效益的干预措施。产品开发合作伙伴关系（PDP）是学术界，制药行业与寻求发现，开发和提供新药物的慈善组织之间的合作努力。 PDP弥合了传统在行业中较低的疾病研究和发展之间的差距，以开发有效的治疗学（小市场规模等）。