This workshop will focus on the need for standards to support the burgeoning biotech and pharma industries developing clinical applications that target the human microbiome. Informed regulatory decision making requires an understanding of the analytical performance of the assays being used to verify the identity, purity, potency and stability of these biomanufactured Live Biotherapeutic Products (LBPs). Additionally, clinical microbiome laboratory tests must be validated before being used for donor screening, monitoring engraftment or evaluating other changes that occur in a patient’s microbiome before, during and after therapeutic intervention.
While next generation sequencing (NGS)-based (metagenomic) methods will be a major emphasis, other analytical methods, such as those being used for enumeration and viability assessment, will also be addressed.
NIST is currently working with our stakeholder community to develop standards for microbiome measurements that will enable federal, academic and industry labs to reliably reproduce each other’s results and advance the overall field.
- Eric Lin, NIST Materials Measurement Laboratory
- Freyja Williams, FDA Center for Biologics Evaluation and Research
- Raja Mazumder, George Washington University
- Brittney Goldberg, FDA Center for Devices and Radiological Health
- Jennifer Barb, NIH Center for Information Technology
- Ben Callahan, NC State University
- Elisha Wood-Charlson, Lawrence Berkeley National Lab
- Raul Cano, The Biocollective
- Scott A. Jackson, NIST Biosystems and Biomaterials Division
- Daryl Gohl, University of Minnesota
- Christian C. Abnet, NIH National Cancer Institute
Ricardo Valladares, Siolta
Dana Walsh, Rebiotix
Kit Goldman, USP
Paul Carlson, FDA/CBER
Jeffrey Heiser, Boston Analytical
Jennifer Balkus, University of Washington
Scott Tighe, University of Vermont
Dieter Tourlousse, AIST
Gregory C A Amos, NIBSC
Phil McQueen, NIH Center for Information Technology