Forecasting for Success: The Power of Regulatory Gap Analysis

| 01 December 2008

With the ever-changing regulatory environment and rapid developments in science, it is hard to keep track of the development strategy for a biomedical product. The best available data and development strategy today might not be good a couple of years from now. One must track not only one's own work but also overall developments in science and worldwide regulatory reviews of similar products, as well as market trends and changes in the political and legal environment. Fewer than 1% of all biomedical products conceived move beyond preclinical testing, and fewer than 10% of products that reach clinical testing make it onto the market. Experts estimate the cost and time to develop a successful drug at about $1.3 billion (US) and 10 years (see Figures 1 and 2). The bulk of this time and money is spent in preclinical and clinical development. Newer drug development models aim to reduce the time and cost of successful biomedical product development.1 However, there is no substitute for a timely assessment of the situation and effective strategies to minimize regulatory failure and shorten time to market. The strategy for regulatory approval could be just as unique as the product itself.


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