Developing Medications for Nicotine Cessation

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DESCRIPTION (provided by applicant): Tobacco use is the leading cause of preventable disease, disability, and death. Despite the fact that addiction represents more than 40% of brain-related illnesses, there is a dearth of innovative treatments, and there is little interest in developing new treatments in the pharmaceutical and biotechnology industry. It is essential that an innovative approach is taken to develop more effective medications for the treatment of nicotine cessation. Our proposed public private partnership (PPP) will provide a comprehensive approach that exploits the latest research discoveries in nicotine dependence and translates this into medications for nicotine cessation. The assembled team has expertise and a demonstrated track record in translating basic research discoveries into medications for addiction in short time-frames. We have developed, implemented and managed a product development pipeline by establishing collaborative partnerships with academic centers, research institutes, government, and private companies. The current cost for developing a new chemical entity is ~$1 billion and as NIDA plans to commit $50 million dollars over 5 years to a public private partnership entity, one of the critical functions of the managing partner will be to raise additional funds by leveraging resources through partnerships. During the UH2 planning phase of the award will form a public private partnership entity that will function as a "virtual pharmaceutical company" devoted to Developing Nicotine Cessation Medicines. By the end of the UH2 phase, we will have established a Board of Directors, advisory boards, established the product development pipeline in consultation with experts in the advisory boards and outside consultants, developed the operations of the organization, establish partnerships via letters of understanding with academic centers and Institutes, pharmaceutical and biotechnology companies, non-government organizations, not-for profit organizations, Foundations and international relations with countries such as China, where the prevalence of smoking is so great it is considered a significant health and economic threat for the country. At the end of the UH2 planning phase the managing partner (MP) will be ready to implement the product development pipeline at the beginning of the UH3 phase. The mission of the PPP will be "patient focused and medicines centered". The product development pipeline will have 10 projects operating simultaneously with the view of developing two new medicines for nicotine cessation. The development process differs significantly in its approach from that of the academic lab and favors a more linear, project management style. The strategy will be to focus on the project at hand, as each project requires a unique array of components for translation. We will draw on the wealth of information from basic and clinical research generated from model organisms such as rodent models, discoveries in molecular neuroscience, systems neuroscience, genetics and clinical research. We have established extensive industry collaborations to source and synthesize compounds using contract chemical companies, biotechnology and pharmaceutical companies that have drug development and clinical trial expertise. The goal will be to develop medicines for addiction by accelerating the pathway of basic research discoveries to the clinic. It is not possible to develop medicines without collaborating with business for intellectual property, licensing and investment as this endeavor needs significant funds and resources. The Gallo Center, the Sanford Burnham Medical Research Institute and University of California San Diego have demonstrated track record as collaborative partners, have experience with a successful bench-to-bedside program for the development of novel therapeutics. Together we have established a medications development program that extends from basic research in addiction, preclinical development, drug discovery and development to human clinical trials. Furthermore, technologies are developed through intellectual property licensing and joint development relationships with biotech and pharmaceutical companies. If we are given the opportunity, we will develop a multidisciplinary collaborative public private product development partnership that aims to move from molecules to medicines by applying a virtual pharma approach to develop novel medications for nicotine cessation. PUBLIC HEALTH RELEVANCE: Despite the fact that by 2030 around 10 million people a year will die of smoking-related illness, there is a dearth of innovative treatments, and relatively little interest in developing new treatments in the pharmaceutical and biotechnology industry. We will develop a multidisciplinary collaborative public private product development partnership that aims to move from molecules to medicines by applying a virtual pharma approach to develop novel medications for nicotine cessation.