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Int J Pharm Med 2006; 20 (5): 327-330 1364-9027/06/0005-0327/$39.95/0 © 2006 Adis Data Information BV. All rights reserved.
Forum Updates in Pharmaceutical Medicine Contents 1. 2. 3. 4. 5. 6. 7. 8.
Speeding to Success . . . . . . . . . . . . . . . . . . . . . Limited Publication of Paediatric Exclusivity Trials . . . . . IOM Committee Releases Recommendations for US FDA Systems for Tracking Investigator-Initiated Trials Lacking . Public-Private Partnership to find Biomarkers . . . . . . . Lancet Issues Call for Phase I Trials . . . . . . . . . . . . . Paediatric Ethicist to Join FDA Office . . . . . . . . . . . . New Appointments for Australian Association . . . . . . .
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1. Speeding to Success Drug companies that develop and launch new products faster than their peers perform consistently better across a number of dimensions, earn higher revenues and have lower development costs, according to a new analysis from the Tufts Center for the Study of Drug Development (CSDD). Between 2000 and 2005, drugs developed by the fastest companies each gained an average of $US1.1 billion in incremental prescription revenue and saved an average of $US30 million in out-of-pocket development costs, compared to those of the slowest companies.1 “Speed demon companies – the fastest drug developers – are consistently implementing efficient R&D practices across their portfolios,” said Ken Getz, senior research fellow at Tufts CSDD and co-author of the study. “These companies have far less development and regulatory time variability, kill projects sooner, and are better at setting resource priorities.” According to Tufts CSDD, Bayer, AstraZeneca, Allergan, Boehringer Ingelheim and Merck & Co. were the five fastest development companies in the 2000–2005 period. These companies were able to shorten development and regulatory cycles by up to 17 months, compared with the average performing drug developers. “Given the high direct cost of development and the substantial opportunity cost for a day of delay in reaching the market, speed and efficiency are central strategic objectives,” Getz noted. “This is especially important today with steadily rising R&D costs, lengthening development and regulatory approval times,
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ever more complex clinical trials, and stubbornly low success rates of drugs moving through clinical development.” The Tufts CSD
