Newsroom
UNITE4TB webinar recap: Expert interview on biomarkers in TB clinical trials
On Thursday 8 June, the second UNITE4TB webinar of 2023 took place, addressing the topic of Biomarkers in TB Clinical Trials. The guest speaker for the session was Prof. Stephen Gillespie from the University of St. Andrews, whose research focuses on modernizing Tuberculosis (TB) diagnostics and therapeutics.
Presentation
In his presentation, Prof. Gillespie, a member of the UNITE4TB Biomarkers Work Package, summarized the current role of biomarkers in TB treatment and clinical trials. He explained the concept of microbiological biomarkers, highlighted the current gold standard techniques (liquid and solid mycobacterial culture), and demonstrated the challenges posed. He also gave an overview of the most important TB biomarkers under evaluation, such as TB22, an immunological biomarker in the form of an end-of-therapy transcriptomic model that could replace culture and serve as an early marker of treatment failure. He noted that PATHFAST sputum LAM and TB-MBLA are both microbiological biomarkers that could serve as replacements for culture, predict long-term outcome, and support drug development.
Discussion
Prof. Gillespie’s presentation was followed by a debate chaired by Prof. Dr. Raquel Duarte (Instituto de Saúde Pública da Universidade do Porto, ISPUP) and Prof. Christoph Lange (Research Center Borstel), together with two members of the UNITE4TB Young Investigators Group: Niklas Köhler (Research Center Borstel) and Dr. Jodie Schildkraut (Radboud University Medical Center).
During the discussion, Prof. Gillespie highlighted the importance of standardization and validation of biomarkers for use in clinical trials and for regulatory approval to use in clinical settings. Although the importance of biomarkers both in clinical trials and for reaching the goal of TB elimination is increasingly recognized, more prioritization by stakeholders will be key in progressing biomarkers from experimental endpoints to tests that can be utilized in routine practice.
Prof. Gillespie also noted that while the cost of biomarkers often seems high, they have the potential to decrease costs in other areas, for example by decreasing the number of study procedures like culture. Finally, he remarked that while he does believe that in the future a single biomarker may be able to predict outcome, it is more likely that a combination of biomarkers will remain the norm.
This was the sixth webinar in the overall series of webinars being organized by our Consortium partners, ISPUP and the European Respiratory Society.
* Click on the web link to see the recording
Follow UNITE4TB on LinkedIn and Twitter to keep informed of the latest project news, including announcements of future webinars.