rug development is a lengthy, complex, and expensive process, requiring hundreds of moving parts to act in concert to bring a therapeutic agent safely to market. According to the Association of Clinical Research Organizations, bringing a new drug or medical device to market can take 20 years and cost as much as $1 billion. Research, product development, and clinical trials involve not only the sponsor’s staff, but regulators, physicians, academic researchers, and patients. This lengthy and complex development cycle, which begins with preclinical research and continues through market approval, involves hundreds if not thousands of people and thousands of pieces of data, which must flow between the different stakeholders. An integral part of the drug development process is the contract research organization sector of the industry, which employs upward of 100,000 individuals, according to some estimates. According to independent analysis, clinical trials conducted by CROs are completed on average 30% more quickly than those conducted in-house. This results in average time savings of four to five months, translating to between $120 million and $150 million in increased revenue potential. Another key sector relates to patient recruitment and retention. According to some experts, this area remains one of the largest bottlenecks in the process for a number of reasons. Companies that specialize in patient recruitment and retention are developing innovative strategies to improve the process while keeping the patient center stage. E-based technologies are another key component of drug development. According to Ira Spector, VP, clinical development operations, Wyeth Research, IT is the underpinning of the modern clinical-trial organization. “About 10 years ago, we strategically focused on our IT systems in terms of how we were going to change trials,” he says. “The first thing we did was to focus on our back office operations. We recognized that the first major component in drug development is about hypothesizing and developing the right protocols. And the back end of drug development is interpreting data and determining if the data validate the hypothesis, and learning what the data tell us about the treatment. Everything else in between is about gaining data efficiently and processing it and turning it into useful information.” These three areas are just a few of the hundreds of moving parts that need to work in concert for successful clinical studies. Many of the top players in the world of drug development will be showcasing their products, services, and expertise at the upcoming 43rd Annual Meeting of the Drug Information Association (DIA) in Atlanta. Featuring more than 550 companies, this is an ideal venue for attendees to network with and evaluate companies from every facet of the biopharmaceutical industry and related fields, from CROs and technology vendors to site research centers, academia, and much more. Taren Grom Editor Taren Grom We look forward to discussing the latest industry trends at DIA in Atlanta. Please stop by Booth 1000 to say hello. VIEW on Clinical Services June 2007

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