Striking the right balance between rapid market access of new drugs and sufficient prior collation of data on their benefit/risk profiles remains a major challenge facing drug regulatory agencies. In their Perspective, Eichler and colleagues describe the associated scientific and regulatory issues and speculate on potential future directions, such as a life-cycle approach to drug regulation. Improving predictions of drug efficacy and safety will help expedite the development and approval of innovative drugs. In the second perspective this month, using examples of recently introduced pharmacogenetic tests and genetic studies of complex disorders including type 2 diabetes and Alzheimer's disease, Roses discusses key issues in the use of pharmacogenetics in drug discovery and development. Alzheimer's disease is one of a range of central nervous system disorders for which inhibition of histone deacetylase (HDAC) activity may be therapeutically beneficial. Current knowledge regarding the role of histone modification in brain homeostasis and disease pathogenesis, as well as recent clinical advances with HDAC-targeted therapeutics, is reviewed by Kazantsev and Thompson. The sirtuin enzymes are highly conserved class III HDACs, which are thought to be involved in the process of ageing. Lavu and colleagues discuss the potential of targeting specific sirtuins to treat age-related disorders, including cancer, metabolic, neurodegenerative and inflammatory diseases. Our last review considers the interleukin-33/ST2 signalling pathway, which has been implicated in various inflammatory disorders, focusing on its emerging role as a therapeutic target and biomarker for cardiovascular disease. Finally, this month we are pleased to introduce a new section — Biobusiness Briefs (p794) — which highlights some of the latest developments related to deals, clinical trial results, regulatory affairs and market trends.
