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Establishing a common language for the stakeholders in stratified medicine — including drug developers, diagnostic companies, regulators and payers — could help tackle the complex challenges posed by biomarker-based drug development.
The Commissioner for Patents at the United States Patent and Trademark Office discusses the challenges that he faces as he takes up his new appointment.
Proteomics techniques can be applied in drug target identification and validation, but data interpretation can be complicated by the identification of proteins in unexpected cellular locations. Here, Butler and Overall discuss the importance of recognizing that many intracellular proteins may have physiological functions in the extracellular compartment, and its implications for drug discovery.
Orloff and colleagues describe how moving from the traditional approach to clinical trials based on sequential, distinct phases towards a more integrated strategy that increases flexibility and maximizes the use of accumulated knowledge could have a key role in improving the efficiency and cost-effectiveness of drug development. Using examples in which novel trial designs have been successfully applied, they also illustrate the use of the tools involved, such as Bayesian methodologies, and discuss the advantages and challenges for their more widespread implementation.
This article investigates pharmaceutical innovation by analysing data on the companies that introduced the ∼1,200 new drugs that have been approved by the US FDA since 1950. Implications of this analysis — which shows that the rate of new drug output in this period has essentially been constant despite the huge increases in R&D investment — are discussed, as well as options to achieve sustainability for the pharmaceutical industry.
Many inhibitors of histone deacetylases (HDACs) are in trials in patients with cancer, but a subset of HDAC inhibitors also have anti-inflammatory or immunosuppressive effects that may be of therapeutic benefit in autoimmune diseases or post-transplantation. Hancock and colleagues describe these effects, highlighting the importance of the ability of some HDAC inhibitors to enhance the production and suppressive functions of FOXP3+regulatory T cells, and discuss the potential to develop class- or subclass-specific HDAC inhibitors as novel immunotherapies.
Voltage-gated K+ channels (KV) are involved in diverse physiological processes and offer important drug development opportunities for cancer and autoimmune diseases, as well as metabolic, neurological and cardiovascular disorders. Here, Wulff and colleagues discuss strategies to pharmacologically modulate KV channels and highlight recent progress in developing drugs that target specific KVsubfamilies.
