Translational Digital Biomarkers Hub

Overview:

Drug development is undergoing a technological transformation, and it is imperative for the industry to leverage emerging technologies to increase clinical relevance and translatability of preclinical in vivo models. Digital biomarkers provide an opportunity to better understand in vivo models and translate new data sources into valuable, actionable insights.

The path to adoption of emerging technologies is not a straightforward one. Digital biomarkers will face similar characterization, validation and regulatory challenges as traditional biomarkers.

Creating easily accessible, centralized hub, where preclinical scientists and regulatory bodies can go to see all of the available preclinical digital biomarker technologies and their capabilities is one of the first steps in expediting interaction with these potentially impactful emerging technologies.

We are looking forward to your engagement with this hub!!!


Complex In Vitro Models (CIVM)

Overview:

Complex in vitro models (i.e. organoids, microphysiological systems, organs-on-chips) have the potential to become an integral part of the drug development workflow. A need exists for more clinically-relevant assays that better predict human clinical results during preclinical discovery and development.  While animal models are very useful and necessary in drug development, there are areas in which CIVM may present an option for more clinically relevant studies and it is the mission of this group to identify and present these models to enable crucial opportunities to refine, reduce and replace animal models.  Additional information and member organizations can be found by following this link.    

History:

Two NA3RsC board members from Novartis and AstraZeneca were running into a common problem and seeing many of their colleagues in the same predicament. They had specific needs they wanted to address in their drug development pipelines, but there were either no viable options for animal models or it would be too expensive or unethical to screen broadly in animals. They wanted to find alternative methods to test their compounds, but they did not know where to look in order to find the latest advances in complex in vitro models. These researchers reached out to management at AxoSim and Mimetas, two developers of microphysiological systems, and together they are seeking solutions.