The FDA and other regulatory agencies consider the integrity of laboratory data to be an integral part of the drug manufacturing process. Deficiencies of out-of-specification (OOS) investigations continue to be the major cause of warning letters in the pharmaceutical industry.

There are several forces driving globalization of R&D. The first is to better target the R&D needs and markets of other nations. A second is to spread the costs of large projects between two partners or more to reduce the risks and costs incurred by each partner. A third is to promote the sale of the R&D results to the countries in which the R&D took place.

Recognize this mobile phone commercial cliché? Well, you might be hearing it in your lab as this phrase is repeated more and more—not relating to poor cell phone service, but the insides of buildings and laboratories.

The only thing that changed was the title. The job, the responsibilities, even the pay were exactly the same, but when the title was changed to director, the relationships, levels of trust, gossip and impediments to getting things done were all out of whack for a couple of months. This is a situation that takes more than simple explanations to fix.

No matter how prepared new researchers think they are for the hazards they’re going to encounter in the lab, it’s pretty likely they’re eventually going to have some type of mishap that reminds them that firsthand experience has no substitute.

Problem: Mass spectrometry (MS) has become an indispensible technology for the analysis of compounds of biological interest, is widely available and offers rapid and accurate detection with broad applicability.

Problem: Pharma and biotech companies are striving to reduce drug attrition rates within the drug discovery process.

The environmental safety and food production industries are facing a rapidly changing climate, being increasingly affected by regulatory and financial pressures.

This simple idea preceded by 15 years the requirements of the OSHA Lab Standard for “Standard Operating Procedures,” “Control Measures” and “Special Provisions for Working with Particularly Hazardous Substances.”

Stephen Barnes, Ph.D., Professor of Pharmacology & Toxicology and Director of the Targeted Metabolomics and Proteomics Laboratory at the University of Alabama at Birmingham (UAB), talks about the changes taking place in the field of mass spectrometry (MS) as it migrates from the research lab to a clinical environment.