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As funding for translational research becomes increasingly available, attention is turning to how to build networks and career structures that will help investigators in the field to flourish.
As a variety of novel cell- or gene-based therapies move closer to the clinic, or to market approval in a few cases, Bethan Hughes explores the rapidly evolving regulatory environment for such products.
The United States Congress is currently considering legislation to create a regulatory pathway for follow-on biologics. Grabowski discusses the importance of data exclusivity in allowing innovator companies to achieve a return on investment before entry of follow-on competitors, and presents an analysis that provides support for a substantial data exclusivity period.
Fatty acid-binding proteins (FABPs) are members of a highly conserved family of proteins central to lipid-mediated processes and related metabolic and immune response pathways. Here, the authors review the functions of individual FABP family members, emphasizing the potential of FABP inhibition as a novel strategy in the treatment of disorders of the metabolic syndrome including obesity, diabetes and atherosclerosis.
MET tyrosine kinase has a central role in cell motility, proliferation and protection from apoptosis — properties that can transform it into a powerful pro-metastatic agent or oncogene. Here, Comoglio and colleagues discuss its biological role in cancer progression, recent progress in MET-targeted therapies, and how to identify the patient populations that might benefit from such treatment.
Successful development of novel anti-atherosclerosis therapies is hampered by the lack of imaging biomarkers for their evaluation. In their article, Lindsay and Choudhury compare and contrast the ability of current atherosclerosis imaging modalities to predict clinical outcomes and discuss the potential of emerging technologies to aid anti-atherosclerosis drug development by quantifying changes in biological function at the level of the atherosclerotic plaque.
In this Review Ebert and Wafford discuss the mechanisms of action of current and emerging hypnotic drugs, emphasizing the importance of taking into account the consequences of disrupted sleep on day-time performance (or quality of wakefulness) when developing new therapeutics.
