Does process excellence handcuff drug development?

R&D expenditures in the pharmaceutical industry have been increasing, whereas the number of new drugs has stagnated. The patent cliff and increasing pricing pressure from payers urge for greater effectiveness and efficiency throughout the industry, including R&D. Good processes are at the heart of increased efficiency, while carefully maintaining and expanding freedom for scientific exploration and innovation.

Omic profiling for drug safety assessment: current trends and public-private partnerships.

The drug development process is currently being hindered by non-optimal prediction of toxicity. Advances in molecular profiling approaches, such as transcriptomics, proteomics and metabolomics, offer the potential to provide a more comprehensive insight into toxicological effects than hitherto possible. These new technologies present their own challenges, however, particularly in relation to standardization and assessment.