Translational Bytes

Dec10 Machine Learning Meets Clinical Pharmacology

Generating “big data” has become increasingly easier and less expensive over the last decade, and the need for computational methods for the analysis of these data are fueling the burgeoning field of data sciences. The challenge for clinical pharmacology will be to rapidly assess and apply new comp...

Houck et al ., recently published a paper in Clinical and Translational Science (CTS) on the first-in-human (FIH) trial for NYX‐2925, a novel N‐methyl‐D‐aspartate receptor modulator . This was a single ‐ center, phase I, randomized, double ‐ blind, placebo ‐ controlled study conducted i...

Nov16 Here in My CAR(T)

In a recent Commentary published in Clinical and Translational Science , Rodriguez-Cartagena and co-authors provide an excellent introductory overview of the emerging field of Chimeric Antigen Receptor (CAR) T-Cell therapeutics . The Commentary provides a comprehensive summary of the scie...

Few topics have received greater interest in the world of early clinical development over the past year than the updated EMA Guidelines on First-in-Human and Early Clinical Trials , finalized in July 2017. Following release of the revised guidelines, the pharmaceutical industry has taken a close...

As our modeling colleagues in drug development remind us, exposure-response (ER) analyses are a critical component to proper dose selection, with the transition from phase II to phase III as a particularly critical juncture. Beyond maximizing efficacy, ER can be incredibly valuable for the interpre...

Biomarkers and diagnostics are a key focus of Clinical and Translational Sciences (CTS) . Biomarkers are the “glue” and common language of translational medicine, and are enjoying a renaissance of increased cross-stakeholder interest. The surge of work in the field of biomarkers include acti...

A recurring challenge in early drug development is the interpretation of emerging safety data from first-in-human (FIH) studies, where typical dose escalation for a novel small molecule follows a 6+2 paradigm, whereby 8 subjects (6 active, 2 placebo) are dosed in each ascending dose cohort. Eme...

The effects of testosterone, the big T, and a testis-derived substance driving male characteristics have been known since antiquity, as farmers knew the effects of castration on decreasing aggression and increasing body weight. Not surprisingly, the path to the discovery of testosterone and solving...

The most recent impact factor (IF) numbers are in, and Clinical and Translational Science (CTS) is clocking in at 1.954, a more than 2-fold increase over the previous year. Simply stated, the IF is a way of assessing journal performance by calculating how often researchers cite journal p...

Have you traveled internationally recently? If you have, I’m sure you’ve had to lug around an electrical adaptor or two to recharge your devices. Why? Because the world does not have one standard for electrical plugs. Can you imagine how convenient it would be if there was one worldwide standard? N...

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