The microbiome continuously shapes its environment through a complex set of interactions, and the microbial flora within and outside the human body has an essential relationship to an organism’s health status. For instance, dysbiosis in the gut microflora is an established contributor to the development of pathological conditions such as chronic inflammatory bowel diseases, type 2 diabetes, and colorectal cancer. In the drug discovery industry, scientists must be proactive in detecting changes in the intestinal microbiome in response to novel therapeutics. Changes to the microbiome associated with probiotic and prebiotic administration must be carefully monitored. Characterizing changes to the gut microbiome whether by metabolic, enzymatic, biomarker, or genomic approaches is fraught with difficulty and has a high assay development and validation cost. Therefore, many companies have looked to partner with research organizations that have success with innovative microbiome analysis tools.

In this webinar, our distinguished speakers, Dr. David Kwok and Dr. David Willoughby discuss current biomarker identification and metabolic evaluation techniques of the human gut microbiome, as well as metagenomic sequencing modalities utilized to streamline results for expedited interpretation and analysis.

In the discovery and investigation of novel biomarkers, tissue immunohistochemistry (IHC) studies are critical. The important question has been how to translate the technology into the clinical laboratory for patient testing once a biomarker target has been identified. Dr. Nan Zhang, VP of Global Central Lab Services at Frontage Laboratories Inc., will provide a valuable update on the application of Tissue IHC in new biomarker development, selection between different types of IHC, and validation of the methodology to be used for patient testing in clinical trials.

Frontage’s newest facility in Hayward, CA started operations in 2022. With over 19,000 in. square footage, it supports bioanalytical and biologics projects. The Biologics Services Department provides exploratory and GLP-compliant Ligand Binding Assay (LBA) services to biotech and pharmaceutical industries, supporting pharmacokinetics (PK), immunogenicity (ADA), and biomarker analysis for protein therapeutics. The Bioanalytical Services Department provides R&D and GLP-compliant, quantitative mass spectrometry services to biotech and pharmaceutical industries, supporting all preclinical and clinical PK / TK / DDI / BA / BE, protein binding, and biomarker studies.