BioPharm International-01-01-2006

On June 13, 2005, in Merck KgaA v. Integra Lifesciences I, Ltd., the US Supreme Court ruled unanimously that the exemption to patent infringement outlined in Title 35, Section 271(e)(1) of the US Code extends to all uses of patented inventions reasonably related to the development and submission of any information under the Food, Drug, and Cosmetic Act, including preclinical studies. In practice, this means that the exemption will allow companies to use other firms' patented compounds for experimentation on drugs that are not ultimately the subject of a submission to the Food and Drug Administration.

Ultra performance liquid chromatography (UPLC) is a new category of liquid chromatography that researchers are using to increase resolution, speed, and sensitivity in a variety of applications. These benefits result from packing columns with 1.7 ?m particles and using instruments that are optimized for such columns.

Sometimes, being human is a drag. Especially in winter. The days are short and cold; the nights are longer and colder. In the gray light of midday, it's tough to be enthusiastic about anything.

Cleaning validation is a critical consideration in the pharmaceutical industry. Inadequate cleaning can result in contamination of drug products with bacteria, endotoxins, active pharmaceuticals from previous batch runs, and cleaning solution residues. Such contaminants must be reduced to safe levels, both for regulatory approval and to ensure patient safety.

These latest pressures on technology relate not only to the need for improved manufacturing productivity and shorter development times, but also to the need to create smarter manufacturing operations

How much of an impact does patent reform, real or imagined, have on biopharmaceutical stocks?

The moral to the story is that the human body is immensely more complex than any computer that we've been able to dream up.

Andrew von Eschenbach, acting commissioner of the Food and Drug Administration (FDA), says that implementing the Critical Path Initiative is "one of my highest priorities," and is encouraging more FDA collaboration with other government agencies, academia, and industrial partners to find better ways to encourage innovation. As head of the National Cancer Institute (NCI), Von Eschenbach has supported joint projects with FDA to spur development of new cancer drugs, including efforts to qualify biomarkers for cancer detection in specific patient populations and to examine how imaging technologies can monitor the impact of therapies on cancer tumors.