Feb08 Wondering About Wearables?
Consumer-oriented wearable devices, which commonly take the form of a wristwatch, have allowed us to quantify our daily movements with fine detail, and even examine the quality of our sleep. But beyond our personal, health-oriented curiosities, wearable devices and the related digital readouts ha... Read More..
Jan15 The Periodic Table of Translation
2019 is the 150th anniversary of periodic table, which transformed chemistry by placing it on firm scientific footing. We envision the Biomedical Data Translator doing the same for translational science. A principal stumbling block in translation is the compartmentalized nature of the tremen... Read More..
Jan08 Ringing in the New Year: 2018 in Review
Happy New Year! By now, you have probably seen the current Clinical and Translational Science (CTS) 2017 impact factor (IF) of 1.954, a more than two-fold increase over the previous year. As you know, IF assesses a journal’s performance by calculating how often researchers cite journal... Read More..
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... Read More..
Nov28 Design, Conduct, and Publication for First‐in‐Human Trials
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... Read More..
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... Read More..
Oct09 Guiding Science with Tutorials: First-in-Human How To
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... Read More..
Sep26 Exposure-Response for Safety? I’ll Believe It When I See It
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... Read More..
Sep10 Imaging the 510(k) Diagnostic Approval Process
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... Read More..
Aug22 Safety Signal or Chance Finding in First-in-Human? There’s a Model for That!
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... Read More..