Getting Personal: FDA's Plan to Save the Drug Industry
This article was originally published in RPM Report
There's no question the pharmaceutical industry is desperate for a more efficient R&D machine, and FDA thinks it has one answer: personalized medicine. But for Big Pharma, the idea runs counter to the commercial reality: no one has yet demonstrated a viable model for making personalized medicine pay off. Knowing where and how to invest in personalized medicine--and taking advantage of FDA's interest the area--will increase the chances of commercial success.
You may also be interested in...
The US FDA’s plan to update a 20-year-old guidance on pharmacogenomic data submissions is a good time to reflect on the dramatic transformation of industry attitudes and approaches to targeted medicine over the past two decades.
An FDA/industry workshop on pharmacogenomics and biomarkers highlighted how far the regulatory system for PKG has evolved. Where industry was afraid to share data with FDA, the conversation is now about how to get the agency the resources it needs to review the data effectively.
An Institute of Medicine workshop on companion diagnostics suggests that regulatory standards are evolving at FDA to encourage companion diagnostic development. But almost everything else is still a challenge.