Considering future qualification for regulatory science in the early development of microphysiological systems: a case study of microthrombosis in a Vessel-on-Chip.

Microphysiological systems (MPS) and Organs-on-Chips (OoCs) hold significant potential for replicating complex human biological processes . However, their widespread adoption by industry and regulatory bodies depends on effective qualification to demonstrate that these models are fit for purpose. Many models developed in academia are not initially designed with qualification in mind, which limits their future implementation in end-user settings.

Novel strategies to assess cytokine release mediated by chimeric antigen receptor T cells based on the adverse outcome pathway concept.

The success of cellular immunotherapies such as chimeric antigen receptor (CAR) T cell therapy has led to their implementation as a revolutionary treatment option for cancer patients. However, the safe translation of such novel immunotherapies, from non-clinical assessment to first-in-human studies is still hampered by the lack of suitable and models recapitulating the complexity of the human immune system. Additionally, using cells derived from human healthy volunteers in such test systems may not adequately reflect the altered state of the patient's immune system thus potentially underestimating the risk of life-threatening conditions, such as cytokine release syndrome (CRS) following CAR T cell therapy.

Out of Sight, Out of Mind? Neuronal Gamma Oscillations During Occlusion Events in Infants.

Object permanence allows infants to interact successfully with objects in the environment. What happens in the human infant brain when objects move in and out of sight? This study used high-density electroencephalography (hdEEG) to record induced oscillatory brain activities in 29 locomotor infants before, during, and after occlusion of a moving object traveling at different speeds. Temporal spectral evolution (TSE) showed that before and after the occlusion event, event-related synchronized (ERS) brain activity was observed, whereas event-related desynchronized (ERD) activity was detected when the car was hidden behind the occluder.

Determinants of Citizens' Intention to Participate in Self-Led Contact Tracing: Cross-Sectional Online Questionnaire Study.

Background: Contact tracing (CT) is a key intervention to contain outbreaks of communicable diseases. During large-scale outbreaks, public health services may lack the resources required to perform CT effectively. One way of mitigating this issue is to shift some of the tasks in CT normally performed by public health services to cases and their contacts, supported by digital tools.