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)：烟草成瘾给社会带来的疾病负担和负面经济影响令人震惊。据预测，目前全球约有6亿吸烟者将死于与吸烟相关的疾病，如慢性阻塞性肺疾病(COPD)、肺癌和心血管疾病。开发有效的戒烟辅助设备被认为是现代医疗保健系统中最具成本效益的干预措施。虽然目前的戒烟剂在临床上是有效的，但其效用非常有限。事实上，即使用目前可用的最有效的药物Chantix和Zyban治疗，复发的风险也很大，这两种药物现在也必须在标签上标上“黑匣子”警告，因为有报道称，与使用它们相关的严重精神健康事件。因此，药物治疗是帮助戒烟努力的有效策略，但迫切需要开发更安全和更有效的治疗方法。产品开发伙伴关系(PDP)是学术界、制药业和寻求发现、开发和提供新药的慈善组织之间的合作努力。PDP弥合了疾病研究和开发之间的差距，对于这些疾病，业界传统上不太重视开发有效的治疗方法。与佛罗里达州斯克里普斯公司合作开发戒烟治疗药物的PDP机制的主要优势是，它充分利用了我们在佛罗里达州斯克里普斯公司的核心使命，开发帮助戒烟的药物，并将这一专业知识与PDP合作伙伴的科学和财政资源相结合。治疗药物将包括小分子(新的和可再利用的、RNA、多肽、抗体和新的制剂和递送机制)。在MITD的UH2阶段，我们将彻底探讨建立一个成功的PDP来开发新的戒烟产品的可行性。在UH3阶段，我们将执行下面描述的里程碑。在MITD PDP的UH2阶段实现的里程碑是：1)构建一个可搜索的生物信息数据库，以确定治疗开发的优先目标。然后，我们将使用数据库报告我们的发现，以及所有可用的烟草成瘾药物发现的科学和战略信息，作为对尼古丁成瘾发现过程的最全面的回顾；以及2)我们将与NIDA项目工作人员一起，在一个重要的科学会议(SRNT或CPDD)和FDA上组织一次研讨会，讨论当前的临床终点，以及开发生物标记物的潜力和效用。我们还将在佛罗里达州TSRI-Scripps举办为期两天的峰会，UH2阶段拨款的所有获得者、NIDA项目官员、领先的学术科学家、可能加入PDP的知名和有前景的行业合作伙伴、负责打击烟草成瘾和吸烟相关疾病的慈善基金会的代表以及佛罗里达州卫生部的官员都将出席。在本次峰会结束时，我们将确定成功推动MITD PDP使命的最佳伙伴关系。在MITD PDP的UH3阶段取得的里程碑是：1)我们将根据UH2阶段的发现填补强大的临床前/临床发现渠道；2)到UH3第三年，我们将有1种化合物进入第二阶段临床试验；以及3)到UH3第五年，我们将有1种化合物进入第三阶段临床试验，另外1-2种化合物进入第二阶段临床试验。 公共卫生相关性：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，目前全球约有6亿吸烟者将死于与吸烟相关的疾病，如慢性阻塞性肺疾病(COPD)、肺癌和心血管疾病。事实上，如果目前的烟草使用趋势持续下去，到2020年，吸烟将成为全球最大的单一健康问题，每年造成约840万人死亡。世界银行估计，在高收入国家，与吸烟相关的医疗费用占所有医疗费用的6%-15%，每年约1600亿美元。在与烟草相关的疾病发作之前戒烟的吸烟者可以在很大程度上避免增加的死亡风险。然而，目前试图戒烟的吸烟者中，约80%会在戒烟的第一个月内复发。开发有效的戒烟辅助设备被认为是现代医疗保健系统中最具成本效益的干预措施。产品开发伙伴关系(PDP)是学术界、制药业和寻求发现、开发和提供新药的慈善组织之间的合作努力。PDP弥合了疾病研究和开发之间的差距，对于这些疾病，业界传统上不太重视开发有效的治疗方法(市场规模较小等)。