Rationale
Rapid diagnosis and treatment are essential for effective TB care and management and for reducing the risk of emerging drug-resistant forms of TB, for which treatment options are more limited, burdensome, and costly. One of the most critical challenges in TB treatment development is the identification of reliable biomarkers to quantitatively assess the sterilizing capacity of new drugs and drug combinations and predict long-term treatment effects better and faster than current culture-based methods. The identification, validation, and integration of drug resistance biomarkers into existing diagnostic platforms would enable prompt adjustment of treatment regimens to improve patient outcomes and reduce the emergence of drug resistance, which is essential to preserve new TB drugs and regimens.
Goals and Objective
The overall goal of GoFAST is to:
- Advance the discovery, development, and validation of novel diagnostics and biomarkers to accelerate the development of new TB drugs and regimens and inform their clinical use, including among persons living with HIV.
- Support and facilitate research to better understand mechanisms of resistance to new and existing TB drugs.
- Advance the development of more efficient and cost-effective drug susceptibility assays that can be deployed at the POC and developed in alignment with ongoing clinical evaluations.
Expected Outcome
GoFAST will support and facilitate collaborations with leading TB researchers and key stakeholders to promote the development of novel biomarkers so as to facilitate decisions for advancing novel regimens to Phase 3 trials, facilitate early detection of drug resistance, and improve monitoring of TB patients on therapy. Such biomarkers should be easy to interpret and portable across clinical phases and should provide data to inform rank ordering and prioritization of regimens for clinical evaluation. Through this effort, FAST-TB aims to develop a strategy for the integration of biomarker assessment in clinical trials.
|
Name |
Organization |
|
David Alland |
Rutgers |
|
Bavesh Kana |
Wits |
|
Norbert Heinrich |
LMU Munich |
|
Christoph Lange |
Research Center Borstel, Leibniz Lung Center |
|
Padmini Salgame |
Rutgers |
|
Daniela Cirillo |
San Raffaele Research Institute |
|
Timothy Walker |
University of Oxford, UK |
|
Gerhard Walzl |
Stellenbosch |
|
Stephany Duda |
Vanderbilt University Medical Center |
|
Christian Lienhardt |
IRD |
|
Adithya Cattamanchi |
UCSF |
|
WG Number |
WG Title |
WG co-leads |
|
WG1 |
Standardization of methods and best practices for evaluation and validation of new markers within clinical trials and observational studies |
Norbert Heinrich |
|
WG2 |
Standardization of biobanking procedures, including improved access to specimens and data to support biomarker discovery and development |
Stephany Duda |
|
WG3/4 |
Development of a roadmap detailing the key gaps linking DST to drug development and the deployment of commercial drugs & Establishment of a framework for DST assay development along ongoing clinical evaluations |
Bavesh Kana |