Oct29 Star Trek: Tissue Chips in Space
“That’s one small step for a man, one giant leap for mankind." — Neil Armstrong
It’s been 50 years since we landed on the moon, and technologic innovation – both in space and on earth – has bounded forward. One of those technology innovations has been microphysiological systems, or “organs-on-c... Read More..
Oct10 Making CAR-T Therapies Go Faster: An FDA Perspective
In a recent Commentary published in Clinical and Translational Science ( CTS ), Dr. Peter Marks, the Director of the US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER), provides a clear and compelling overview of the FDA's flexible regulatory app... Read More..
Sep30 #Science: Can Excessive Screen Time Improve Medication Adherence and Patient Safety?
There is much debate among parents, educators, and employers about the appropriate amount of screen time. In fact, most families and schools have developed rules surrounding the use of social media and electronic communication apps with the intent of preserving the human interactions that are so cr... Read More..
Sep16 Dishing Out the QT Risk
Early identification of QT-prolongation or pro-arrhythmic risk for drugs in development has historically relied on binding or functional assays for hERG and other ion channels, with follow-up studies in animals. This hERG-to-animal approach entails a jump from simple and relatively uncertain to cos... Read More..
Aug21 Moving the Needle for Liquid Biopsy
Historically, cancer detection and drug response monitoring required collecting tumor biopsies, which can be a very invasive procedure, to characterize many types of solid tumors such as non-small cell lung cancer (NSCLC), and is practically infeasible for many others. Furthermore, given their inva... Read More..
Aug09 Learn and Confirm? Or Confirm and Learn the Hard Way?
A recent publication in CTS by Lyauk et al . presents results from an evaluation of dose selection in NDAs approved by the FDA between 2015 and 2017, in an effort to characterize the extent to which sponsors follow the “learn and confirm” paradigm of dose selection. Read More..
Jul19 CTS Impact Factor More Than Doubles to 3.989 for the Second Year in a Row!
The most recent impact factor (IF) numbers are in, and Clinical and Translational Science (CTS) has again doubled its IF to 3.989. The 2018 IF is the first year that we “own” the entire metric. Last year, we owned half the 2017 metric and the IF was 1.954, while two years ago, the old editori... Read More..
Jul12 The Difference Is Night and Day
Does your study call for recurrent measurement of heart rate or blood pressure? If so, read “ Models of Variability and Circadian Rhythm in Heart Rate, Blood Pressure, and QT Interval for Healthy Subjects Who Received Placebo in Phase I Trials ” by Mukul Minocha et al . In this creative appr... Read More..
Jun30 Adding to the Transporter DDI Toolbox
Jun14 Children Are Not Little Adults
There is a saying in experimental pharmacology that preclinical species are not little humans. In clinical pharmacology, the same sentiment is true for pediatric populations. You do not need to be a parent or a pediatrician to realize that children are not just mini versions of adults. Yet a common... Read More..