Biomarkers & Clinical Endpoints Workgroup Q3-2015 Update
The BCE-WG identifies, develops consensus, and builds the evidence base to submit potential biomarkers and clinical endpoints that have promise in the development of new TB medical products to FDA and EMA for regulatory review and qualification in a specific context of use when applicable.
- The BCE-WG has paused while the Liquid Culture assessment is being completed via the M&S-WG and is awaiting the advancement of discovery-based BMs.
- The BCE-WG is finalizing the following whitepapers for publication submission:
- Kathleen D. Eisenach: “Sputum Liquid Culture and TPP”.
- Andrew Nunn: “Experience with Endpoints in BMRC Trials using Solid Media”
- Stephen H. Gillespie & Ellen Jo Baron: “Molecular Biomarkers in Tuberculosis”.
- Gerhard Walzl: “Immune Biomarkers for TB Treatment Response”.