Author: Dr. Chitra Lele, Sciformix Corporation
The pharmaceutical industry is under growing pressure from the complexities of the drug development process, hardening drug safety standards, increased regulatory scrutiny and the ongoing patent cliff. Indeed, it is estimated that $217 billion worth of originator products will have lost patent protection by 2018, with $150 billion of this amount predicted to be lost between 2010 and 2017 (1,2).
Leading innovators are constantly looking for new ways to pick up this shortfall – notably through emerging markets, which offer opportunities due to their spending power, potential for high volumes and offshoring capabilities. In addition, companies are looking to new strategies in the product lifecycle process to bring products to market faster. Better quality data and analyses are setting the stage for more rapid, informed decisions.
Given that only about 9% of all therapies will be approved in early clinical studies – with many being lost due to outdated and impractical trial designs (3) – this is an area in which signiﬁ cant improvements can be made in cost, quality and resources.