Why Your R&D Externalization Strategy Needs A Laboratory Informatics Strategy

For the last several years, a rebounding global economy combined with a growing demand for advanced therapeutics has resulted in robust pipelines and the highest FDA approval rates seen in decades.  As a result of heighted R&D activity, we are seeing more rapid commercialization of innovative drugs for patients. Congress has also recently introduced a new bill called the 21st Century Cures Act designed to further speed up approvals and remove red tape.  Medical devices are following a similar suit.  According to a Food and Drug Administration2015 performance report, the approval rate for high-risk medical devices jumped to 98 percent in 2015, a 12 percent increase from the previous year and an almost 30 percent approval increase from 2012.