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A High-throughput Compatible Assay to Evaluate Drug Efficacy against Macrophage Passaged Mycobacterium tuberculosis
Published on: March 24, 2017
Addressing challenges along the 'access cascade' for new TB regimens
J Servello1, P de Colombani1, L Dall'Olio1
1Centre for Multidisciplinary Research in Health Science, Universita' di Milano, Milan, Italy.
Abstract:
This is a decisive moment with multiple new chemical entities progressing through the TB drug pipeline. Our review aims to contribute to policy discussion around these new TB treatments, primarily to increase the chance of successfully and rapidly adopting new regimens where they are most needed. Our analysis is based on: i) stakeholder engagement efforts undertaken in the context of UNITE4TB (a global clinical trial consortium for development of new TB drugs and regimens), ii) the outcomes of a special session of the UNITE4TB Annual Meeting 2024 in which representatives from several key stakeholder groups (pharmaceutical, clinical, research, regulatory, oversight, and advocacy) spoke on the topic of access to new TB regimens; and iii) a review of the literature. We propose a model for an 'access cascade' detailing the necessary steps from early research and development to the introduction of new regimens into clinical care. We then determined potential bottlenecks that might impede equitable access to new TB regimens globally, and conclude with recommended actions for stakeholders to take to overcome or mitigate the effects of these bottlenecks.
Insights
New tuberculosis (TB) treatments are advancing. This review proposes an
Area of Science:
- Drug development and infectious diseases.
- Global health policy and access to medicines.
- Clinical trial consortia and regulatory affairs.
Background:
- Multiple novel chemical entities are progressing through the tuberculosis (TB) drug development pipeline.
- There is a critical need to ensure timely and equitable access to new TB treatments.
- The UNITE4TB consortium is a global effort focused on developing new TB drugs and regimens.
Purpose of the Study:
- To inform policy discussions on the adoption of new TB treatments.
- To identify and address potential bottlenecks in accessing new TB regimens.
- To propose actionable recommendations for stakeholders to facilitate equitable global access.
Main Methods:
- Analysis of stakeholder engagement within the UNITE4TB consortium.
- Review of outcomes from a UNITE4TB Annual Meeting 2024 session with diverse stakeholder representation.
- Comprehensive literature review on TB drug access and policy.
Main Results:
- A proposed 'access cascade' model outlining the stages from R&D to clinical care.
- Identification of potential bottlenecks hindering equitable global access to new TB regimens.
- Development of stakeholder-specific recommendations to overcome access barriers.
Conclusions:
- Addressing bottlenecks in the access cascade is crucial for successful TB treatment adoption.
- Collaborative action among pharmaceutical, clinical, research, regulatory, oversight, and advocacy groups is essential.
- Proactive strategies are needed to ensure new TB regimens reach all populations equitably and rapidly.
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