Bridging the gap between microbiomics and clinical regulations

Join us for an enlightening session with Nikolaj Sørensen, Phd, VP of Operational Excellence and Compliance at Cmbio. 

The human microbiome, the microbes living on and in us, is a key player in health and disease. Studies in recent years have found that it can influence everything from gastrointestinal health to immune responses and even mental health. Thus, the microbiome has a huge therapeutic potential, but significant unsolved regulatory hurdles complicate the development of microbiome-based therapeutic interventions.

Unlike the methods typically used in clinical trials, the science of microbiomics is characterized by the following challenging features:

• There are no universally accepted standard methods
• A lack of reference materials
• Highly multivariate datasets with high variability
• Complex and computationally intensive bioinformatics
• Big data

As a result, using microbiomics in clinical trials often means forging new paths.

What you will learn

• What are the discrepancies between microbiomics and research more typical of clinical trials?
• What reference materials are currently available, and how can they be used?
• How do we translate traditional validation approaches to fit a format which is applicable to microbiomics?

Many of the issues facing microbiomics in a clinical context also apply to untageted metabolomics, which will also be subject to discussion.