Posted 01 October 2008 | By
Former UK Prime Minister Harold Macmillan once said, "to be alive at all involves some risk." This statement is especially apt for a biomedical product development enterprise. Successful product development and commercialization require integration of multiple disciplines, each with its own complexities and risks. Drug developers need to worry about issues such as intellectual property, preclinical and clinical testing, business development and financial sustainability. Due to the logistics of the process, which could take up to 10 years and cost hundreds of millions of dollars, it is not surprising that most small and medium-size enterprises (SMEs) in the pharmaceutical industry do not end up with profits. And, since SMEs constitute more than 90% of this industry, that translates into a huge waste of money and resources. More importantly, SMEs are a major source of new products, either directly or indirectly, by licensing or selling their products to large enterprises.