The main objective of ERA4TB is to create a European open platform to accelerate the development of new regimens for the treatment of tuberculosis. To reach this goal, the consortium has set the following specific objectives:
– Implementation of state-of-the-art tools and capacities into an open platform for the evaluation of TB drug candidates to effectively progress compounds from early preclinical to clinical development and identify potential new Pan-tuberculosis (Pan-TB)1 regimens ready for Phase II clinical evaluation.
– Development of modelling and simulation tools and application of standard and new artificial intelligence (AI) techniques for better characterization of pharmacokinetic-pharmacodynamic (PK/PD) relationships (concentration-effect or exposure-response relationships depending on the trial), optimization of clinical trial design, prediction of therapeutic dose range and antibacterial activity in humans.
– Management of data generated by the project, integrating also data and knowledge from historical datasets available in reference databases and from previous and existing consortia and projects, in the context of an ever-improving ‘learning system’ that allows to refine the platform continuously.
– Provision of a flexible and efficient management structure able to adapt to the capacity and resource allocation level required by each platform component at each stage of the project, depending on each compound’s progression and attrition dynamics and on inherent variables of the multiple combination assays.
– Provide a sustainability plan that incorporates all the synergies and lessons learned within the project and secures the survival of the platform beyond the life of the project.
– Define and execute an outreach, engagement, dissemination and communication plan in collaboration with regulatory authorities and other stakeholders, including patient organizations, to maximize the impact of the project.