By Rob Wright
Prior to heading out to the 32nd Annual J.P. Morgan Healthcare Conference in San Francisco last month, I stumbled across several article headlines indicating the United States's domination of global biomedical R&D was fading. What metric was used to determine this? R&D spend. According to “new” research from the University of Michigan Health System, the U.S. share of the global biomedical R&D business declined from 51 percent to a mere 45 percent from 2007 to 2012. And while Europe remained unchanged at 29 percent, Asia rose from 18 to 24 percent.
By Karl Schick, Innovation Manager
Sensors designed for incorporation into disposable purification platforms, i.e. single-use tangential flow filtration (TFF), single-use normal flow filtration (NFF), or disposable chromatography, must meet a number of challenging requirements.
By Ruth Olmer, Christina Kropp, Claudia Huether-Franken, and Robert Zweigerdt
The routine application of human pluripotent stem cells and their derivatives in regenerative medicine and innovative drug discovery will require the constant supply of high cell numbers in consistent high quality.
By Jennifer Goldsmith, VP of Vault, Veeva Systems
According to a 2012 Trial Master File (TMF) Reference Model survey of 500 sponsors, CROs, and consultants, 28 percent of respondents are currently using an electronic TMF (eTMF) while 57 percent are in the process of planning, building, or evaluating an eTMF — a 12 percentage point jump since 2010. Most eTMFs today are used like electronic filing cabinets, merely a scanned archive of TMF information. Only a small fraction leverage the eTMF's ability to deliver business insights that provide true strategic value to the organization.
By Dirk Ahlbrecht, Sartorius Group
The U.S. Pharmacopeial (USP) Convention's Chapter 41 minimum quality standards for weights and balances have been updated after twenty years — and every pharmaceutical manufacturer is waiting to see what that means in practice.