T-Cell Priming Targets Identified with Help from Single-Cell Genomics

Currently established rapid methods for sterility testing of advanced therapy medicinal products (ATMPs) are mostly based on growth-based processes or the detection of metabolic activities. However, the requirements for real-time measurement and the testing of cell-containing products cannot be met with most of these methods.

Virtual or “siteless” clinical trials allow trial coordinators and patients to conduct clinical study visits via online video calls and collect data via handheld or wearable devices. In addition, virtual trials increase the size and diversity of the patient pool, accelerate recruiting, and generate more informative, clinically-relevant data that is accepted by regulatory agencies. However, moving from traditional to virtual trials presents challenges as clinical trial sponsors learn how to design, execute, and complete effective virtual trials. To assure success, trial sponsors need to better understand the digital tools and platforms used in virtual trials, how to manage the data collection they enable, and the pitfalls to avoid. In this webinar, Bernard Munos, a pioneering pharmaceutical industry innovator, and Transparency Life Sciences co-founder Dr. Tomasz Sablinski will provide an overview of the strategies leaders are finding helpful in adopting and adapting to virtual trials.

Epidemiological studies show the beneficial effects of exercise during pregnancy in alleviating birth-related complications and improving neonatal metabolic health, whereas the underlying molecular mechanisms remain unclear. A protocol for maternal exercise (ME) of mice facilitates mechanistic exploration based on the regimen of the exercise guidelines for pregnant women. Treadmill exercise allows precise control of exercise intensity and duration compared to voluntary wheel running exercise, which leads to reduced variations among individual mouse within treatments and facilitates translation into ME in humans.

When a developed virus filtration process is validated by viral clearance testing, the addition of a virus spike for just this purpose can lead to disappointing results.