QbD is fundamentally about how to build quality into a process to design and make a product versus trying to test the quality into a product. The ideation of the process and the final manufactured product starts early in development with process engineering and formulation. In order to clearly understand the “design space” information about the process, the product needs to be captured and made available to enable scientists to understand and determine the critical quality attributes that effect a product. Scientific informatics is thus fundamental in supporting QbD and more specifically, an ELN that provides the context of who did what, why and when around a product design and process.
ELNs are now playing a key role in early to late development and thus are an integral part of the informatics life cycle that supports QbD. The new evolution of the ELN to be able to create and capture workflows, as well as new data access and analysis, now supports pharma development to deploy and better support an informatics environment to deliver QbD. If you’re interested I’d highly recommend reading the new QbD article just published by Accelrys that discusses the role of informatics in support of QbD and specifically the role of the ELN.
Click the link to read the new white paper--and do, by all means, let me know what you think!
It was interesting to read the following research report findings from Thompson Reuters:
“Academic pharma patents more than trebling, from 602 in 2005 to 2025 in 2010”.
"This seems to show that [industry] is patenting more than ever in efforts to protect its intellectual property developments, but also academia is waking up to the need to protect itself, and raise its ability to generate revenue streams," the report claims. IP and Pharma funding is now becoming a significant source of funding for academia and especially important in light of drying government and research body grants. Recent changes for US patent laws to a 'first to file' process from a 'first to invent', funding paucity from government and the transient nature of academic research staff, mean that it is now more important than ever to protect, keep safe and prevent IP related to future patents from “wandering”.
Today’s# ELN is# now ideally suited for academic deployment. Web based, zero installation, low cost of ownership, ease of use and little reliance on IT resources now enables any university or group of universities to embrace an informatics infrastructure to capture and protect IP. Today we see universities being able to deploy ELNs to over 5000 users.
An ELN provides a secure environment that can be rapidly deployed to protect research information and also provides a means to trace and defend research “secrets” straying into other institutions as a result of a migrant work force. From a competitive funding perspective, universities that have embraced an informatics infrastructure that better manages and protects research information in a highly transferable electronic format with Pharma partners are arguably more likely to receive research funding.
So what's holding up academia from joining the other 154 thousand estimated ELN users in the world?