Journal for Clinical Studies
Author: Dr. Chitra Lele, Sciformix Corporation
The growing complexities of the drug development process, toughening drug safety standards, increased regulatory scrutiny, and ongoing patent cliff have placed significant pressure on the pharmaceutical industry. An estimated $217bn worth of originator products will have lost patent protection by 20181, with $150bn of this figure predicted to be lost between 2010 and 20172. In addition, with the number of blockbuster drugs coming off patent year-on-year, many innovators are increasingly examining how best to pick up the deficit. Emerging markets offer many opportunities for innovators undertaking this strategy, thanks to their spending power, potential for high volumes and offshoring capabilities.
Companies are also looking to employ new strategies in the product lifecycle process to bring products faster to market with new models, tools, technologies and processes. Better quality data and analyses set the stage for faster, more informed decisions. With about 85% of all therapies failing in early clinical trials, many being lost due to outdated and impractical clinical trial designs3, this is an area where significant improvements can be made in cost, quality and resources