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To understand why “business as usual” is no longer an option for the research-based drug industry, it is worth considering some of the myriad challenges that drug companies currently face. At the top of the list is the upcoming onslaught of patent expirations of many highrevenue- generating branded medicines. Between 2009 and 2012, worldwide sales for these products will exceed $112 billion (Table 1). Included in this list are 36 blockbusters (drugs with annual sales of $1 billion or more). Some important examples include Singulair (montelukast), with more than $4 billion in annual sales (patent expiration in 2012); Plavix (clopidogrel), with more than $8 billion in annual sales (patent expiration in 2011); and Lipitor (atorvastatin), with an industry-leading $13.7 billion in annual sales (patent expiration in 2010). Given that only 3 in 10 new products, on average, generate revenues equal to or greater than average industry R&D costs,1 the loss of patent protection on these blockbusters represents a very real threat to the industry's ability to sustain its own growth. Without question, many of the large pharma mergers and acquisitions announced in 2009 reflect the industry's desire to avoid the imminent danger of the patent cliff, rather than an interest in enhancing R&D capabilities or scope.

The current environment for innovation presents formidable economic, regulatory, and political challenges for the research-based pharmaceutical industry. In particular, the growing time, cost, and risk related to drug development are stubborn obstacles to filling industry pipelines and boosting the output of new pharmaceutical and biological products. Presented here is a model of an innovation network. Although structures may vary, the innovation network offers the best mechanism to ensure viability and economic success for all sectors of the pharmaceutical and biotechnology industry, as well as the uninterrupted flow of innovative lifesaving and life-improving medicines for waiting patients.

The Rise of Contract Research Organizations Clinical trials are administered by investigators at hospitals, academic institutions or managed sites. The investigators find and enroll healthy and symptomatic volunteers, each of whom is required to sign an informed consent acknowledging acceptance of the drug and its potential side effects. The testing protocol and informed consent form are monitored by Institutional Review Boards ('IRBs') in the sites where the trials are conducted. In essence, the IRB acts as an ethics committee to ensure the safety of patients and volunteers. Once clinical trials are completed, the data are subjected to biostatistical analysis over a 6 to 12 month period.'3 If the data yield promising results, the sponsor seeks final approval though a New Drug Application ('NDA'). The NDA must contain all scientific information the sponsor has gathered and typically fills 100,000 pages or more.'4 During the review period, the FDA assesses the safety and effectiveness of the drug, the manufacturing process, and the risk-benefit calculus.'5 By law, the FDA has 180 days to either approve the application or notify the sponsor of the opportunity to request a hearing on the merits of the application.'6 In practice, ho本论文由英语论文网提供整理，提供论文代写，英语论文代写，代写论文，代写英语论文，代写留学生论文，代写英文论文，留学生论文代写相关核心关键词搜索。